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


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


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


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


Replacing periodic in-office follow-ups with remote follow-ups for 2 years in pacemaker patients committed to remote monitoring does not increase the occurrence of major cardiovascular events and reduces resource consumption. Registration: URL: https://clinicaltrials.gov; Unique identifier: NCT01523704.",2020,"Only 1.4% of remote follow-ups triggered an unscheduled in-office follow-up, and only 1.5% of scheduled in-office follow-ups were considered actionable.  ","['In Japan, consecutive pacemaker patients committed to RM', '1274 randomized patients (50.4% female, age 77±10 years), 558 (RFU) and 550 (CFU) patients reached either the primary endpoint or 24 months follow-up', 'Pacemaker Patients with Biennial In-clinic Evaluation', 'pacemaker patients for two years']","['exclusive remote follow-up (RFU', 'RFU']","['composite of death, stroke, or cardiovascular events requiring surgery, and the primary hypothesis was non-inferiority with 5% margin', 'median (IQR) number of in-office follow-ups']","[{'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3844103', 'cui_str': '550'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",1274.0,0.189135,"Only 1.4% of remote follow-ups triggered an unscheduled in-office follow-up, and only 1.5% of scheduled in-office follow-ups were considered actionable.  ","[{'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Watanabe', 'Affiliation': 'Department of Cardiology, Fujita Health University School of Medicine, Aichi (E.W.).'}, {'ForeName': 'Fumio', 'Initials': 'F', 'LastName': 'Yamazaki', 'Affiliation': 'Department of Cardiovascular Surgery, Shizuoka City Shizuoka Hospital (F.Y.).'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Goto', 'Affiliation': 'Department of Cardiology, Nagoya City University Hospital (T.G.), Aichi, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Asai', 'Affiliation': 'Department of Cardiology, Ichinomiya Municipal Hospital (T. Asai), Aichi, Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Cardiology, Handa City Hospital (T. Yamamoto), Aichi, Japan.'}, {'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Hirooka', 'Affiliation': 'Department of Cardiology, National Hospital Organization Osaka National Hospital (K.H.), Tokyo, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Department of Cardiology, Kyorin University Hospital (T.S.), Tokyo, Japan.'}, {'ForeName': 'Atsunobu', 'Initials': 'A', 'LastName': 'Kasai', 'Affiliation': 'Department of Cardiology, Japanese Red Cross Ise Hospital, Mie (A.K.).'}, {'ForeName': 'Marehiko', 'Initials': 'M', 'LastName': 'Ueda', 'Affiliation': 'Department of Cardiology, Chiba University Hospital (M.U.), Tokyo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Yamakawa', 'Affiliation': 'Department of Cardiology, Teikyo University Hospital (T. Yamakawa), Tokyo, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Ueda', 'Affiliation': 'Department of Cardiology, Osaka Police Hospital, Japan (Y.U.).'}, {'ForeName': 'Katsuhito', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Cardiology, Kochi Health Sciences Center, Japan (K.Y.).'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Tokunaga', 'Affiliation': 'Department of Cardiology, JA Toride Medical Ctr, Ibaraki, Japan (T.T.).'}, {'ForeName': 'Yoshinao', 'Initials': 'Y', 'LastName': 'Sugai', 'Affiliation': 'Department of Cardiology, Hiraka General Hospital, Akita, Japan (Y.S.).'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Department of Cardiology, Kasukabe Chuo General Hospital, Saitama, Japan (K.T.).'}, {'ForeName': 'Shigeki', 'Initials': 'S', 'LastName': 'Hiramatsu', 'Affiliation': 'Department of Cardiology, Fukuyama Cardiovascular Hospital, Hiroshima, Japan (S.H.).'}, {'ForeName': 'Tomoharu', 'Initials': 'T', 'LastName': 'Arakawa', 'Affiliation': 'Department of Cardiology, Daido Hospital, Aichi, Japan (T. Arakawa).'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Schrader', 'Affiliation': 'Biotronik, Berlin, Germany (J.S.).'}, {'ForeName': 'Niraj', 'Initials': 'N', 'LastName': 'Varma', 'Affiliation': 'Cleveland Clinic, Heart & Vascular Institute, OH (N.V.).'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ando', 'Affiliation': 'Department of Cardiology, Kokura Memorial Hospital, Fukuoka, Japan (K.A.).'}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.119.007734']
1,32338932,Predictors and moderators of treatment outcome in a randomized clinical trial for binge-eating disorder.,"OBJECTIVE


The current study examined predictors and moderators of two interventions for binge-eating disorder (BED).
METHOD


Participants were 112 adults with BED ( M age  = 39.7 ± 13.4 years;  M BMI  = 35.1 ± 13.4 kg/m²; 82% female; 91% Caucasian) randomly assigned to integrative cognitive-affective therapy for BED (ICAT-BED) or guided self-help cognitive-behavioral therapy (CBTgsh). Generalized linear models examined predictors and moderators of objective binge-eating episode (OBE) frequency and OBE abstinence at end-of-treatment (EOT) and 6-month follow-up (FU).
RESULTS


Lower levels of baseline dietary restraint and emotion regulation difficulties predicted greater reductions in OBE frequency at EOT and FU, respectively. At EOT, greater pretreatment self-control predicted greater reductions in OBE frequency in ICAT-BED than CBTgsh ( p s < .05). In addition, low shape/weight overvaluation predicted greater reductions in OBE frequency in ICAT-BED than CBTgsh, whereas high shape/weight overvaluation predicted comparable reductions in OBE frequency across treatments at EOT ( p s < .02). At EOT and FU, greater baseline actual-ideal self-discrepancy predicted significantly greater reductions in OBE frequency in ICAT-BED, than CBTgsh ( p s < .02). No significant predictor or moderator effects were observed for models examining OBE abstinence.
CONCLUSION


This study identified two general predictors and four moderators of BED treatment response. However, only one predictor (actual-ideal self-discrepancy) interacted with treatment type to differentially predict OBE frequencies at both EOT and FU. Altogether, findings suggest that ICAT-BED may confer specific and durable improvements in OBE frequencies among individuals with high actual-ideal self-discrepancy. Therefore, patients demonstrating these characteristics may be more likely to benefit from ICAT-BED. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"RESULTS


Lower levels of baseline dietary restraint and emotion regulation difficulties predicted greater reductions in OBE frequency at EOT and FU, respectively.","['Participants were 112 adults with BED ( M age  = 39.7 ± 13.4 years;  M BMI  = 35.1 ± 13.4 kg/m²; 82% female; 91% Caucasian', 'binge-eating disorder (BED']","['integrative cognitive-affective therapy for BED (ICAT-BED) or guided self-help cognitive-behavioral therapy (CBTgsh', 'ICAT-BED', 'treatment (EOT) and 6-month follow-up (FU']","['objective binge-eating episode (OBE) frequency and OBE abstinence', 'OBE frequencies', 'binge-eating disorder', 'OBE frequency']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517558', 'cui_str': '13.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C2733435', 'cui_str': 'Guided self-help cognitive behavioral therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}]",112.0,0.0252791,"RESULTS


Lower levels of baseline dietary restraint and emotion regulation difficulties predicted greater reductions in OBE frequency at EOT and FU, respectively.","[{'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Anderson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Minnesota Medical School.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Smith', 'Affiliation': 'Department of Psychiatry and The Behavioral Sciences, University of Southern California.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Schaefer', 'Affiliation': 'Sanford Center for Biobehavioral Research.'}, {'ForeName': 'Ross D', 'Initials': 'RD', 'LastName': 'Crosby', 'Affiliation': 'Sanford Center for Biobehavioral Research.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'Sanford Center for Biobehavioral Research.'}, {'ForeName': 'Scott G', 'Initials': 'SG', 'LastName': 'Engel', 'Affiliation': 'Sanford Center for Biobehavioral Research.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Crow', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Minnesota Medical School.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Wonderlich', 'Affiliation': 'Sanford Center for Biobehavioral Research.'}, {'ForeName': 'Carol B', 'Initials': 'CB', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Minnesota Medical School.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000503']
2,32339248,Effect of High vs Low Doses of Chloroquine Diphosphate as Adjunctive Therapy for Patients Hospitalized With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection: A Randomized Clinical Trial.,"Importance


There is no specific antiviral therapy recommended for coronavirus disease 2019 (COVID-19). In vitro studies indicate that the antiviral effect of chloroquine diphosphate (CQ) requires a high concentration of the drug.
Objective


To evaluate the safety and efficacy of 2 CQ dosages in patients with severe COVID-19.
Design, Setting, and Participants


This parallel, double-masked, randomized, phase IIb clinical trial with 81 adult patients who were hospitalized with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection was conducted from March 23 to April 5, 2020, at a tertiary care facility in Manaus, Brazilian Amazon.
Interventions


Patients were allocated to receive high-dosage CQ (ie, 600 mg CQ twice daily for 10 days) or low-dosage CQ (ie, 450 mg twice daily on day 1 and once daily for 4 days).
Main Outcomes and Measures


Primary outcome was reduction in lethality by at least 50% in the high-dosage group compared with the low-dosage group. Data presented here refer primarily to safety and lethality outcomes during treatment on day 13. Secondary end points included participant clinical status, laboratory examinations, and electrocardiogram results. Outcomes will be presented to day 28. Viral respiratory secretion RNA detection was performed on days 0 and 4.
Results


Out of a predefined sample size of 440 patients, 81 were enrolled (41 [50.6%] to high-dosage group and 40 [49.4%] to low-dosage group). Enrolled patients had a mean (SD) age of 51.1 (13.9) years, and most (60 [75.3%]) were men. Older age (mean [SD] age, 54.7 [13.7] years vs 47.4 [13.3] years) and more heart disease (5 of 28 [17.9%] vs 0) were seen in the high-dose group. Viral RNA was detected in 31 of 40 (77.5%) and 31 of 41 (75.6%) patients in the low-dosage and high-dosage groups, respectively. Lethality until day 13 was 39.0% in the high-dosage group (16 of 41) and 15.0% in the low-dosage group (6 of 40). The high-dosage group presented more instance of QTc interval greater than 500 milliseconds (7 of 37 [18.9%]) compared with the low-dosage group (4 of 36 [11.1%]). Respiratory secretion at day 4 was negative in only 6 of 27 patients (22.2%).
Conclusions and Relevance


The preliminary findings of this study suggest that the higher CQ dosage should not be recommended for critically ill patients with COVID-19 because of its potential safety hazards, especially when taken concurrently with azithromycin and oseltamivir. These findings cannot be extrapolated to patients with nonsevere COVID-19.
Trial Registration


ClinicalTrials.gov Identifier: NCT04323527.",2020,"Viral RNA was detected in 31 of 40 (77.5%) and 31 of 41 (75.6%) patients in the low-dosage and high-dosage groups, respectively.","['Patients Hospitalized With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2', 'Older age (mean [SD] age, 54.7 [13.7] years vs 47.4 [13.3] years) and more heart disease (5 of 28 [17.9%] vs 0) were seen in the high-dose group', 'Enrolled patients had a mean (SD) age of 51.1 (13.9) years, and most (60 [75.3%]) were men', '81 adult patients who were hospitalized with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection was conducted from March 23 to April 5, 2020, at a tertiary care facility in Manaus, Brazilian Amazon', 'patients with severe COVID-19']","['high-dosage CQ ', 'azithromycin and oseltamivir', 'Chloroquine Diphosphate', 'chloroquine diphosphate (CQ', 'low-dosage CQ ']","['participant clinical status, laboratory examinations, and electrocardiogram results', 'instance of QTc interval', 'safety and efficacy', 'Viral respiratory secretion RNA detection', 'safety and lethality outcomes', 'Lethality', 'Respiratory secretion', 'Infection', 'Viral RNA', 'reduction in lethality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C4517562', 'cui_str': '13.9'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0055447', 'cui_str': 'Chloroquine phosphate'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0260877', 'cui_str': 'Laboratory examination'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C1532372', 'cui_str': 'Respiratory secretion'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0035736', 'cui_str': 'Viral RNA'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",81.0,0.0816988,"Viral RNA was detected in 31 of 40 (77.5%) and 31 of 41 (75.6%) patients in the low-dosage and high-dosage groups, respectively.","[{'ForeName': 'Mayla Gabriela Silva', 'Initials': 'MGS', 'LastName': 'Borba', 'Affiliation': 'Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Fernando Fonseca Almeida', 'Initials': 'FFA', 'LastName': 'Val', 'Affiliation': 'Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Vanderson Souza', 'Initials': 'VS', 'LastName': 'Sampaio', 'Affiliation': 'Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Marcia Almeida Araújo', 'Initials': 'MAA', 'LastName': 'Alexandre', 'Affiliation': 'Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Gisely Cardoso', 'Initials': 'GC', 'LastName': 'Melo', 'Affiliation': 'Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Brito', 'Affiliation': 'Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Maria Paula Gomes', 'Initials': 'MPG', 'LastName': 'Mourão', 'Affiliation': 'Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'José Diego', 'Initials': 'JD', 'LastName': 'Brito-Sousa', 'Affiliation': 'Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Djane', 'Initials': 'D', 'LastName': 'Baía-da-Silva', 'Affiliation': 'Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Marcus Vinitius Farias', 'Initials': 'MVF', 'LastName': 'Guerra', 'Affiliation': 'Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Ludhmila Abrahão', 'Initials': 'LA', 'LastName': 'Hajjar', 'Affiliation': 'Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rosemary Costa', 'Initials': 'RC', 'LastName': 'Pinto', 'Affiliation': 'Fundação de Vigilância em Saúde do Amazonas, Manaus, Brazil.'}, {'ForeName': 'Antonio Alcirley Silva', 'Initials': 'AAS', 'LastName': 'Balieiro', 'Affiliation': 'Instituto Leônidas and Maria Deane, Fiocruz Amazonas, Manaus, Brazil.'}, {'ForeName': 'Antônio Guilherme Fonseca', 'Initials': 'AGF', 'LastName': 'Pacheco', 'Affiliation': 'Programa de Computação Científica, Fiocruz, Rio de Janeiro, Brazil.'}, {'ForeName': 'James Dean Oliveira', 'Initials': 'JDO', 'LastName': 'Santos', 'Affiliation': 'Universidade Federal do Amazonas, Manaus, Brazil.'}, {'ForeName': 'Felipe Gomes', 'Initials': 'FG', 'LastName': 'Naveca', 'Affiliation': 'Instituto Leônidas and Maria Deane, Fiocruz Amazonas, Manaus, Brazil.'}, {'ForeName': 'Mariana Simão', 'Initials': 'MS', 'LastName': 'Xavier', 'Affiliation': 'Instituto Nacional de Infectologia Carlos Chagas-Fiocruz, Rio de Janeiro, Brazil.'}, {'ForeName': 'André Machado', 'Initials': 'AM', 'LastName': 'Siqueira', 'Affiliation': 'Instituto Nacional de Infectologia Carlos Chagas-Fiocruz, Rio de Janeiro, Brazil.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Schwarzbold', 'Affiliation': 'Universidade Federal de Santa Maria, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Júlio', 'Initials': 'J', 'LastName': 'Croda', 'Affiliation': 'Faculdade de Medicina da Universidade Federal do Mato Grosso do Sul, Campo Grande, Brazil.'}, {'ForeName': 'Maurício Lacerda', 'Initials': 'ML', 'LastName': 'Nogueira', 'Affiliation': 'Faculdade de Medicina de São José do Rio Preto, São Paulo, Brazil.'}, {'ForeName': 'Gustavo Adolfo Sierra', 'Initials': 'GAS', 'LastName': 'Romero', 'Affiliation': 'Universidade de Brasília, Brasília, Brazil.'}, {'ForeName': 'Quique', 'Initials': 'Q', 'LastName': 'Bassat', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Cor Jesus', 'Initials': 'CJ', 'LastName': 'Fontes', 'Affiliation': 'Universidade Federal de Mato Grosso, Mato Grosso, Brazil.'}, {'ForeName': 'Bernardino Cláudio', 'Initials': 'BC', 'LastName': 'Albuquerque', 'Affiliation': 'Faculdade de Medicina da Universidade Federal do Amazonas, Manaus, Brazil.'}, {'ForeName': 'Cláudio-Tadeu', 'Initials': 'CT', 'LastName': 'Daniel-Ribeiro', 'Affiliation': 'Instituto Oswaldo Cruz, Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.'}, {'ForeName': 'Wuelton Marcelo', 'Initials': 'WM', 'LastName': 'Monteiro', 'Affiliation': 'Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Marcus Vinícius Guimarães', 'Initials': 'MVG', 'LastName': 'Lacerda', 'Affiliation': 'Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA network open,['10.1001/jamanetworkopen.2020.8857']
3,32339933,"Comments on ""A multicentre prospective randomized controlled clinical trial comparing the effectiveness and cost of a static air mattress and alternating air pressure mattress to prevent pressure ulcers in nursing home residents"": Letter to the editor and authors' reponse.",,2020,,['nursing home residents'],['static air mattress and alternating air pressure mattress'],[],"[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0024940', 'cui_str': 'Mattress'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0001876', 'cui_str': 'Air pressure'}]",[],,0.0890545,,"[{'ForeName': 'W', 'Initials': 'W', 'LastName': 'Fagart', 'Affiliation': ""Centre d'Evaluation des Dispositif Médicaux-Handicap (CEDM-H), CHU de Nîmes, 30029 Nîmes, France. Electronic address: willy.fagart@chu-nimes.fr.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'De La Bachelerie', 'Affiliation': ""Centre d'Evaluation des Dispositif Médicaux-Handicap (CEDM-H), CHU de Nîmes, 30029 Nîmes, France.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Blot', 'Affiliation': ""Centre d'Evaluation des Dispositif Médicaux-Handicap (CEDM-H), CHU de Nîmes, 30029 Nîmes, France.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dupeyron', 'Affiliation': 'Département de Médecine Physique et de Réadaptation, CHU de Nîmes, 30029 Nîmes, France.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Chevalier', 'Affiliation': 'Laboratoire De Biostatistique, Épidémiologie, Santé Publique, Informatique Médicale, CHU de Nîmes, 30029 Nîmes, France.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103547']
4,32366927,Effects of chronic type 5 phosphodiesterase inhibition on penile microvascular reactivity in hypertensive patients with erectile dysfunction: a randomized crossover placebo-controlled trial.,"This randomized crossover and placebo-controlled trial evaluated the effects of daily use of sildenafil citrate (SIL, 1-month 50 mg twice daily) on penile and systemic endothelial microvascular function in hypertensive patients presenting with erectile dysfunction. The effects of SIL on arterial pressure were evaluated using ambulatory blood pressure monitoring (ABPM). Fifty patients diagnosed with primary arterial hypertension and erectile dysfunction (aged 57.4 ± 5.6 years), recruited in a tertiary public hospital, were treated with SIL (50 mg twice daily) or placebo (PLA) for two 30-day periods with a 30-day washout between them. Laser speckle contrast imaging coupled with acetylcholine skin iontophoresis was used to evaluate penile and systemic (forearm) cutaneous microvascular reactivity. SIL treatment increased penile basal microvascular flow (P = 0.002) and maximal endothelial-dependent peak response to skin iontophoresis of acetylcholine (ACh, P = 0.006). The area under the curve of microvascular vasodilation induced by ACh was also significantly increased (P = 0.02). Lastly, SIL treatment did not modify systemic microvascular reactivity. Twenty-four-hour ABPM (P = 0.0002) and daytime (P = 0.002) and nighttime (P = 0.001) mean diastolic blood pressure values were significantly reduced after SIL treatment. The scores of the Simplified International Index of Erectile Function (P < 0.0001) and the number of patients with positive responses to Sexual Encounter Profile question 3 (P < 0.0001) also increased after SIL treatment. Penile endothelium-dependent microvascular reactivity improved after continuous use of sildenafil in hypertensive patients with erectile dysfunction; the treatment also reduced blood pressure, suggesting that, in addition to improving erectile function, daily use of sildenafil could improve blood pressure control.",2020,"SIL treatment increased penile basal microvascular flow (P = 0.002) and maximal endothelial-dependent peak response to skin iontophoresis of acetylcholine (ACh, P = 0.006).","['hypertensive patients with erectile dysfunction', 'hypertensive patients presenting with erectile dysfunction', 'Fifty patients diagnosed with primary arterial hypertension and erectile dysfunction (aged 57.4\u2009±\u20095.6 years), recruited in a tertiary public hospital']","['SIL', 'Laser speckle contrast imaging coupled with acetylcholine skin iontophoresis', 'sildenafil', 'chronic type 5 phosphodiesterase inhibition', 'sildenafil citrate (SIL, 1-month 50\u2009mg twice daily', 'placebo (PLA', 'placebo']","['penile and systemic endothelial microvascular function', 'penile microvascular reactivity', 'ambulatory blood pressure monitoring (ABPM', 'blood pressure control', 'systemic microvascular reactivity', 'area under the curve of microvascular vasodilation', 'daytime', 'mean diastolic blood pressure values', 'microvascular reactivity', 'scores of the Simplified International Index of Erectile Function', 'penile basal microvascular flow', 'penile and systemic (forearm) cutaneous microvascular reactivity', 'arterial pressure']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C4517794', 'cui_str': '5.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}]","[{'cui': 'C0257766', 'cui_str': 'SILV protein, human'}, {'cui': 'C3854375', 'cui_str': 'Laser speckle contrast imaging'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0022024', 'cui_str': 'Iontophoresis procedure'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0457499', 'cui_str': 'Type 5'}, {'cui': 'C0031640', 'cui_str': 'Phosphoric diester hydrolase'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0724693', 'cui_str': 'Sildenafil citrate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030851', 'cui_str': 'Penile structure'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0232108', 'cui_str': 'Arterial pulse pressure'}]",50.0,0.0960623,"SIL treatment increased penile basal microvascular flow (P = 0.002) and maximal endothelial-dependent peak response to skin iontophoresis of acetylcholine (ACh, P = 0.006).","[{'ForeName': 'Valéria', 'Initials': 'V', 'LastName': 'Verri', 'Affiliation': 'National Institute of Cardiology, Ministry of Health, Rio de Janeiro, Brazil.'}, {'ForeName': 'Alessandro R', 'Initials': 'AR', 'LastName': 'Nascimento', 'Affiliation': 'National Institute of Cardiology, Ministry of Health, Rio de Janeiro, Brazil.'}, {'ForeName': 'Andrea A', 'Initials': 'AA', 'LastName': 'Brandao', 'Affiliation': 'State University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Tibirica', 'Affiliation': 'National Institute of Cardiology, Ministry of Health, Rio de Janeiro, Brazil. etibi@uol.com.br.'}]",Journal of human hypertension,['10.1038/s41371-020-0343-3']
5,32340121,Acute Caffeine Supplementation Does Not Improve Performance in Trained CrossFit ®  Athletes.,"Caffeine's ergogenic effects persist during various exercise modalities; however, information establishing its efficacy during CrossFit ®  protocols is limited. This study aimed to determine the effects of caffeine supplementation on CrossFit ®  performance. Twenty CrossFit ® -trained men (age = 26.7 ± 6.2 years, experience = 3.7 ± 2.9 years) were randomized in a double-blind, crossover design. Participants completed two sessions separated by a seven-day washout period, 60 min after consuming 5 mg/kg body mass of caffeine or a placebo. In each session, participants completed as many rounds as possible in 20 min of five pull-ups, 10 push-ups, and 15 air squats. CrossFit ®  performance was the total number of repetitions completed in 20 min. Paired-samples t-tests were used to compare CrossFit ®  performance between caffeine and placebo conditions and to test for a potential learning effect between the first and second sessions. CrossFit ®  performance was not significantly different during the caffeine condition compared to the placebo (468.6 ± 114.7 vs. 466.7 ± 94.3 repetitions,  p  = 0.861). A significant learning effect was identified between the first and second sessions (452.4 ± 101 vs. 483.8 ± 106.5 repetitions,  p  = 0.001), with no significant effect of treatment order ( p  = 0.438). Caffeine's ergogenic effect were not present during the CrossFit ®  workout ""Cindy""; however, future research should include familiarization sessions and examine other CrossFit ®  workouts in novice and women participants.",2020,"CrossFit ®  performance was not significantly different during the caffeine condition compared to the placebo (468.6 ± 114.7 vs. 466.7 ± 94.3 repetitions,  ","['Trained CrossFit ®  Athletes', 'Twenty CrossFit ® -trained men (age = 26.7 ± 6.2 years, experience = 3.7 ± 2.9 years']","['caffeine or a placebo', 'caffeine supplementation', 'Caffeine', 'Acute Caffeine Supplementation', 'placebo']","['CrossFit ®  performance', 'learning effect']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C4517641', 'cui_str': '2.9'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.135352,"CrossFit ®  performance was not significantly different during the caffeine condition compared to the placebo (468.6 ± 114.7 vs. 466.7 ± 94.3 repetitions,  ","[{'ForeName': 'Jesse A', 'Initials': 'JA', 'LastName': 'Stein', 'Affiliation': 'Department of Kinesiology, College of Health and Human Sciences, Kansas State University, Manhattan, KS 66506, USA.'}, {'ForeName': 'Melitza', 'Initials': 'M', 'LastName': 'Ramirez', 'Affiliation': 'Department of Kinesiology, College of Health and Human Sciences, Kansas State University, Manhattan, KS 66506, USA.'}, {'ForeName': 'Katie M', 'Initials': 'KM', 'LastName': 'Heinrich', 'Affiliation': 'Department of Kinesiology, College of Health and Human Sciences, Kansas State University, Manhattan, KS 66506, USA.'}]","Sports (Basel, Switzerland)",['10.3390/sports8040054']
6,32340530,Cardiovascular Risk and Resilience Among Black Adults: Rationale and Design of the MECA Study.,"Background Cardiovascular disease incidence, prevalence, morbidity, and mortality have declined in the past several decades; however, disparities persist among subsets of the population. Notably, blacks have not experienced the same improvements on the whole as whites. Furthermore, frequent reports of relatively poorer health statistics among the black population have led to a broad assumption that black race reliably predicts relatively poorer health outcomes. However, substantial intraethnic and intraracial heterogeneity exists; moreover, individuals with similar risk factors and environmental exposures are often known to experience vastly different cardiovascular health outcomes. Thus, some individuals have good outcomes even in the presence of cardiovascular risk factors, a concept known as resilience. Methods and Results The MECA (Morehouse-Emory Center for Health Equity) Study was designed to investigate the multilevel exposures that contribute to ""resilience"" in the face of risk for poor cardiovascular health among blacks in the greater Atlanta, GA, metropolitan area. We used census tract data to determine ""at-risk"" and ""resilient"" neighborhoods with high or low prevalence of cardiovascular morbidity and mortality, based on cardiovascular death, hospitalization, and emergency department visits for blacks. More than 1400 individuals from these census tracts assented to demographic, health, and psychosocial questionnaires administered through telephone surveys. Afterwards, ≈500 individuals were recruited to enroll in a clinical study, where risk biomarkers, such as oxidative stress, and inflammatory markers, endothelial progenitor cells, metabolomic and microRNA profiles, and subclinical vascular dysfunction were measured. In addition, comprehensive behavioral questionnaires were collected and ideal cardiovascular health metrics were assessed using the American Heart Association's Life Simple 7 measure. Last, 150 individuals with low Life Simple 7 were recruited and randomized to a behavioral mobile health (eHealth) plus health coach or eHealth only intervention and followed up for improvement. Conclusions The MECA Study is investigating socioenvironmental and individual behavioral measures that promote resilience to cardiovascular disease in blacks by assessing biological, functional, and molecular mechanisms. REGISTRATION URL: https://www.clini​caltr​ials.gov. Unique identifier: NCT03308812.",2020,"Notably, blacks have not experienced the same improvements on the whole as whites.","['blacks in the greater Atlanta, GA, metropolitan area', 'Black Adults', '≈500 individuals', '150 individuals with low Life Simple 7 were recruited and randomized to a']",['behavioral mobile health (eHealth) plus health coach or eHealth only intervention'],"['oxidative stress, and inflammatory markers, endothelial progenitor cells, metabolomic and microRNA profiles, and subclinical vascular dysfunction', ' Cardiovascular disease incidence, prevalence, morbidity, and mortality', 'Cardiovascular Risk and Resilience']","[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0303134', 'cui_str': 'Beryllium-7'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2317129', 'cui_str': 'Health coach'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}]",,0.0394992,"Notably, blacks have not experienced the same improvements on the whole as whites.","[{'ForeName': 'Shabatun J', 'Initials': 'SJ', 'LastName': 'Islam', 'Affiliation': 'Division of Cardiology Department of Medicine Emory University School of Medicine Atlanta GA.'}, {'ForeName': 'Jeong Hwan', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology Department of Medicine Emory University School of Medicine Atlanta GA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Topel', 'Affiliation': 'Division of Cardiology Department of Medicine Emory University School of Medicine Atlanta GA.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Division of Cardiology Department of Medicine Emory University School of Medicine Atlanta GA.'}, {'ForeName': 'Yi-An', 'Initials': 'YA', 'LastName': 'Ko', 'Affiliation': 'Department of Biostatistics and Bioinformatics Rollins School of Public Health Emory University Atlanta GA.'}, {'ForeName': 'Mahasin S', 'Initials': 'MS', 'LastName': 'Mujahid', 'Affiliation': 'Division of Epidemiology School of Public Health University of California Berkeley CA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Sims', 'Affiliation': 'Department of Medicine University of Mississippi Medical Center Jackson MS.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Mubasher', 'Affiliation': 'Department of Community Health and Preventive Medicine Morehouse School of Medicine Atlanta GA.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Ejaz', 'Affiliation': 'Division of Cardiology Department of Medicine Emory University School of Medicine Atlanta GA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Morgan-Billingslea', 'Affiliation': 'Department of Community Health and Preventive Medicine Morehouse School of Medicine Atlanta GA.'}, {'ForeName': 'Kia', 'Initials': 'K', 'LastName': 'Jones', 'Affiliation': 'Division of Cardiology Department of Medicine Emory University School of Medicine Atlanta GA.'}, {'ForeName': 'Edmund K', 'Initials': 'EK', 'LastName': 'Waller', 'Affiliation': 'Department of Hematology and Oncology Winship Cancer Institute Emory University School of Medicine Atlanta GA.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Jones', 'Affiliation': 'Division of Pulmonary, Allergy, Critical Care and Sleep Medicine Department of Medicine Emory University School of Medicine Atlanta GA.'}, {'ForeName': 'Karan', 'Initials': 'K', 'LastName': 'Uppal', 'Affiliation': 'Division of Pulmonary, Allergy, Critical Care and Sleep Medicine Department of Medicine Emory University School of Medicine Atlanta GA.'}, {'ForeName': 'Sandra B', 'Initials': 'SB', 'LastName': 'Dunbar', 'Affiliation': 'Nell Hodgson Woodruff School of Nursing Emory University Atlanta GA.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Pemu', 'Affiliation': 'Department of Medicine Morehouse School of Medicine Atlanta GA.'}, {'ForeName': 'Viola', 'Initials': 'V', 'LastName': 'Vaccarino', 'Affiliation': 'Division of Cardiology Department of Medicine Emory University School of Medicine Atlanta GA.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Searles', 'Affiliation': 'Division of Cardiology Department of Medicine Emory University School of Medicine Atlanta GA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Baltrus', 'Affiliation': 'Department of Community Health and Preventive Medicine Morehouse School of Medicine Atlanta GA.'}, {'ForeName': 'Tené T', 'Initials': 'TT', 'LastName': 'Lewis', 'Affiliation': 'Department of Epidemiology Rollins School of Public Health Emory University Atlanta GA.'}, {'ForeName': 'Arshed A', 'Initials': 'AA', 'LastName': 'Quyyumi', 'Affiliation': 'Division of Cardiology Department of Medicine Emory University School of Medicine Atlanta GA.'}, {'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'Taylor', 'Affiliation': 'Department of Medicine Morehouse School of Medicine Atlanta GA.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.015247']
7,32341121,Dopamine and Risky Decision-Making in Gambling Disorder.,"Gambling disorder is a behavioral addiction associated with impairments in value-based decision-making and cognitive control. These functions are thought to be regulated by dopamine within fronto-striatal circuits, but the role of altered dopamine neurotransmission in the etiology of gambling disorder remains controversial. Preliminary evidence suggests that increasing frontal dopamine tone might improve cognitive functioning in gambling disorder. We therefore examined whether increasing frontal dopamine tone via a single dose of the catechol- O -methyltransferase (COMT) inhibitor tolcapone would reduce risky choice in human gamblers ( n  = 14) in a randomized double-blind placebo-controlled crossover study. Data were analyzed using hierarchical Bayesian parameter estimation and a combined risky choice drift diffusion model (DDM). Model comparison revealed a nonlinear mapping from value differences to trial-wise drift rates, confirming recent findings. An increase in risk-taking under tolcapone versus placebo was about five times more likely, given the data, than a decrease [Bayes factor (BF) = 0.2]. Examination of drug effects on diffusion model parameters revealed that an increase in the value dependency of the drift rate under tolcapone was about thirteen times more likely than a decrease (BF = 0.073). In contrast, a reduction in the maximum drift rate under tolcapone was about seven times more likely than an increase (BF = 7.51). Results add to previous work on COMT inhibitors in behavioral addictions and to mounting evidence for the applicability of diffusion models in value-based decision-making. Future work should focus on individual genetic, clinical and cognitive factors that might account for heterogeneity in the effects of COMT inhibition.",2020,"Gambling disorder is associated with impairments in value-based decision-making and cognitive control, functions regulated by the neurotransmitter dopamine.","['gambling disorder', 'human gamblers (n=14']","['catechol-O-methyltransferase (COMT) inhibitor tolcapone', 'Dopamine', 'frontal dopamine tone via the catechol-O-methyltransferase (COMT) inhibitor tolcapone', 'tolcapone vs. placebo', 'tolcapone', 'placebo']","['maximum drift rate under tolcapone', 'risky choice', 'value-dependency of the drift rate under tolcapone', 'cognitive functioning']","[{'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0858352', 'cui_str': 'Gambler'}]","[{'cui': 'C0007407', 'cui_str': 'Catechol methyltransferase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0246330', 'cui_str': 'tolcapone'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0246330', 'cui_str': 'tolcapone'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]",,0.0953733,"Gambling disorder is associated with impairments in value-based decision-making and cognitive control, functions regulated by the neurotransmitter dopamine.","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Peters', 'Affiliation': 'Department of Psychology, Biological Psychology, University of Cologne, Cologne 50923, Germany jan.peters@uni-koeln.de.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Vega', 'Affiliation': 'Department of Neurology, VA Northern California Healthcare System, San Francisco, CA 94121.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Weinstein', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Mitchell', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Kayser', 'Affiliation': 'Department of Neurology, VA Northern California Healthcare System, San Francisco, CA 94121.'}]",eNeuro,['10.1523/ENEURO.0461-19.2020']
8,32347208,"Yoga improves balance, mobility, and perceived occupational performance in adults with chronic brain injury: A preliminary investigation.","BACKGROUND AND PURPOSE


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


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


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


We observed significant improvements in balance, mobility, and self-reported occupational performance in adults with chronic brain injury.",2020,"Significant improvement was observed post-yoga in balance (p = 0.05), mobility (p = 0.03), and self-reported occupational performance (p = 0.04).
","['Nine participants with chronic brain injury were recruited, and seven (four female) completed the study', 'adults with brain injury', 'Participants served as their own controls', 'adults with chronic brain injury']",[],"['self-reported occupational performance', 'balance confidence, pain, and occupational performance and satisfaction', 'balance, mobility, and perceived occupational performance', 'functional deficits', 'balance, mobility, and self-reported occupational performance', 'mobility']","[{'cui': 'C0751813', 'cui_str': 'Chronic Brain Injury'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",9.0,0.0225685,"Significant improvement was observed post-yoga in balance (p = 0.05), mobility (p = 0.03), and self-reported occupational performance (p = 0.04).
","[{'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Stephens', 'Affiliation': 'Colorado State University, Department of Occupational Therapy, USA. Electronic address: jaclyn.stephens@colostate.edu.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Van Puymbroeck', 'Affiliation': 'Clemson University, Recreational Therapy Program, USA.'}, {'ForeName': 'P L', 'Initials': 'PL', 'LastName': 'Sample', 'Affiliation': 'Colorado State University, Department of Occupational Therapy, USA. Electronic address: pat.sample@colostate.edu.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Schmid', 'Affiliation': 'Colorado State University, Department of Occupational Therapy, USA. Electronic address: arlene.schmid@colostate.edu.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101172']
9,32342266,Application of Vitamin E Acetate on Staple Lines and Anastomoses of Roux-en-Y Gastric Bypass: Impact on Postoperative Pain and Acute Phase Reactants.,"PURPOSE


Postoperative pain after laparoscopic surgery has 3 components: parietal, visceral, and associated with pneumoperitoneum. Visceral pain accounts for around 30% of the total pain and is less amenable to be controlled by multimodal analgesia. The topical application of vitamin E ointment has demonstrated an anti-inflammatory effect in the local inflammatory response against surgical aggression. Vitamin E has been also associated with a reduction in postoperative pain of skin wounds. The aim of this study was to evaluate the effect of the topical application of vitamin E acetate on staple lines and anastomoses of Roux-en-Y gastric bypass, as part of a multimodal analgesia scheme within an Enhanced Recovery After Surgery (ERAS) program.
METHODS


A prospective randomized clinical trial was performed. Patients were divided into 2 groups: patients receiving a topical application of vitamin E on staple lines and anastomoses (G1) and patients not receiving it (G2). The primary endpoint was postoperative pain, as measured by VAS 24 h after surgery. Secondary outcomes include morphine rescue needs, acute phase reactants 24 h after surgery, and hospital stay.
RESULTS


One hundred forty patients were included, 70 in each group. Postoperative pain was 10 mm in G1 and 21.8 mm in G2 (p < 0.001). Morphine needs within the first 24 h were 2.9% in G1 and 13.2% in G2 (p = 0.026). C-reactive protein levels were significantly lower in G1 (8.7 mg/dL vs 11.9; p = 0.016). Mean hospital stay was 2.1 days in G1 and 2.9 in G2 (p = 0.019).
CONCLUSION


Topical application of vitamin E reduces postoperative pain and acute phase reactants, allowing an earlier discharge.
TRIAL REGISTRATION


NCT03765827, https://www.clinicaltrials.gov.",2020,Postoperative pain was 10 mm in G1 and 21.8 mm in G2 (p < 0.001).,"['Staple Lines and Anastomoses of Roux-en-Y Gastric Bypass', 'One hundred forty patients were included, 70 in each group']","['vitamin E acetate', 'Vitamin E Acetate', 'Morphine', 'topical application of vitamin E on staple lines and anastomoses (G1) and patients not receiving it (G2', 'vitamin E', 'vitamin E ointment', 'Vitamin E']","['staple lines and anastomoses of Roux-en-Y gastric bypass', 'morphine rescue needs, acute phase reactants 24\xa0h after surgery, and hospital stay', 'Mean hospital stay', 'Visceral pain', 'postoperative pain', 'postoperative pain and acute phase reactants', 'Postoperative Pain and Acute Phase Reactants', 'Postoperative pain', 'C-reactive protein levels']","[{'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0078373', 'cui_str': 'Tocopherol Acetate'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}]","[{'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0001347', 'cui_str': 'Acute phase reactant'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0234245', 'cui_str': 'Visceral pain'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}]",140.0,0.12876,Postoperative pain was 10 mm in G1 and 21.8 mm in G2 (p < 0.001).,"[{'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Ruiz-Tovar', 'Affiliation': 'Bariatric and Metabolic Surgery Unit, Rey Juan Carlos University Hospital, Gladiolo, s/n, 28933, Madrid, Spain. jruiztovar@gmail.com.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Garcia', 'Affiliation': 'Bariatric and Metabolic Surgery Unit, Rey Juan Carlos University Hospital, Gladiolo, s/n, 28933, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ferrigni', 'Affiliation': 'Bariatric and Metabolic Surgery Unit, Rey Juan Carlos University Hospital, Gladiolo, s/n, 28933, Madrid, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Duran', 'Affiliation': 'Bariatric and Metabolic Surgery Unit, Rey Juan Carlos University Hospital, Gladiolo, s/n, 28933, Madrid, Spain.'}]",Obesity surgery,['10.1007/s11695-020-04635-9']
10,32341291,Test-Retest Reliability and the Effects of Exercise on the King-Devick Test.,"OBJECTIVE


To determine the test-retest reliability and the influence of exercise on King-Devick (K-D) test performance.
DESIGN


Crossover study design.
SETTING


Controlled laboratory.
PARTICIPANTS


Participants consisted of 63 (39 women and 24 men) healthy, recreationally active college students who were 21.0 + 1.5 years of age.
INDEPENDENT VARIABLES


Participants completed the K-D test using a 2-week, test-retest interval. The K-D test was administered before and after a counterbalanced exercise or rest intervention. Reliability was assessed using testing visits (visit 1 and visit 2) as the independent variables. Exercise or rest and time (baseline, postintervention) were used as independent variables to examine the influence of exercise.
MAIN OUTCOME MEASURES


Intraclass correlation (ICC) coefficients with 95% confidence intervals were calculated between visits to assess reliability of K-D test completion time. A repeated-measure 2 x 2 analysis of variance (intervention × time) with post hoc paired t tests was used to assess the influence of exercise on K-D test performance.
RESULTS


The K-D test was observed to have strong test-retest reliability [ICC2,1 = 0.90 (0.71, 0.96)] over time. No significant intervention-by-time interaction (P = 0.55) or intervention main effects (P = 0.68) on K-D time were observed. Mean differences of -1.5 and -1.7 seconds (P < 0.001) were observed between baseline and rest and exercise interventions for K-D test performance, respectively. Up to 32% (20/63) of participants were observed to have a false-positive K-D test performance before and after each intervention.
CONCLUSIONS


Although strong test-retest reliability coefficients were observed using clinically relevant time points, a high false-positive rate warrants caution when interpreting the K-D test.",2020,"Up to 32% (20/63) of participants were observed to have a false-positive K-D test performance before and after each intervention.
","['Participants consisted of 63 (39 women and 24 men) healthy, recreationally active college students who were 21.0 + 1.5 years of age']",['counterbalanced exercise or rest intervention'],"['Reliability', 'Exercise or rest and time (baseline, postintervention', 'K-D time', 'false-positive K-D test performance', 'King-Devick (K-D) test performance']","[{'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C4759290', 'cui_str': 'King-Devick test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.088008,"Up to 32% (20/63) of participants were observed to have a false-positive K-D test performance before and after each intervention.
","[{'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Eddy', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Goetschius', 'Affiliation': 'Department of Exercise Science and Athletic Training, Adrian College, Adrian, Michigan.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Hertel', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Resch', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, Virginia.'}]",Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine,['10.1097/JSM.0000000000000586']
11,32347209,"Evaluation of the effectiveness of self-healing training on self-compassion, body image concern, and recovery process in patients with skin cancer.","BACKGROUND AND PURPOSE


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


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


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


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


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


Self-healing training significantly increased self-compassion, including self-kindness, self-judgment, and sense of common humanity (p < 0.01), and decreased the level of body image concern, isolation, and over-identification (p < 0.05).
","[{'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Latifi', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran. Electronic address: latifizh@gmail.com.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Soltani', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran.'}, {'ForeName': 'Shokoufeh', 'Initials': 'S', 'LastName': 'Mousavi', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101180']
12,32343994,Effects of electronic cigarette on platelet and vascular function after four months of use.,"We examined the effects of electronic cigarette on platelet and vascular function after 4 months of use compared to tobacco smoking. Forty smokers without cardiovascular disease were randomized to smoke either conventional cigarettes or an electronic cigarette (nicotine concentration of 12 mg/ml). At baseline and after four months, we measured a) platelet function by Platelet Function Analyzer PFA-100 and Light Transmission Aggregometry, b) pulse wave velocity, c) plasma malondialdehyde levels as oxidative stress index and d) the exhaled CO level. After 4 months, continuation of conventional cigarette smoking further impaired platelet function compared to vaping as assessed by PFA (mean increase 27.1 vs 11.6 s, p for interaction = 0.048) and by LTA (decline 24.1 vs 9.4%, p for interaction = 0.045). Conversely, compared to smoking, vaping resulted in greater reduction of exhaled CO (6.9 ppm vs 2.6, p for interaction < 0.001), improvement of PWV (decrease of 0.8 m/s vs increase of 0.8 m/s, p for interaction = 0.020) and reduction of MDA (reduction 0.13 vs increase 0.19 nmol/L, p for interaction = 0.035). Switching to electronic cigarette for 4 months has a neutral effect on platelet function while it reduces arterial stiffness and oxidative stress compared to tobacco smoking.",2020,"After 4 months, continuation of conventional cigarette smoking further impaired platelet function compared to vaping as assessed by PFA (mean increase 27.1 vs 11.6 s, p for interaction = 0.048) and by LTA (decline 24.1 vs 9.4%, p for interaction = 0.045).",['Forty smokers without cardiovascular disease'],"['electronic cigarette', 'conventional cigarettes or an electronic cigarette (nicotine concentration of 12\u202fmg/ml']","['exhaled CO', 'platelet function', 'platelet and vascular function', 'improvement of PWV', 'arterial stiffness and oxidative stress', 'reduction of MDA', 'platelet function by Platelet Function Analyzer PFA-100 and Light Transmission Aggregometry, b) pulse wave velocity, c) plasma malondialdehyde levels as oxidative stress index and d) the exhaled CO level']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439294', 'cui_str': 'g/L'}]","[{'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0920267', 'cui_str': 'Platelet aggregation test'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0179038', 'cui_str': 'Analyzer'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",40.0,0.0199673,"After 4 months, continuation of conventional cigarette smoking further impaired platelet function compared to vaping as assessed by PFA (mean increase 27.1 vs 11.6 s, p for interaction = 0.048) and by LTA (decline 24.1 vs 9.4%, p for interaction = 0.045).","[{'ForeName': 'Ignatios', 'Initials': 'I', 'LastName': 'Ikonomidis', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece. Electronic address: ignoik@gmail.com.""}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Katogiannis', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Gavriella', 'Initials': 'G', 'LastName': 'Kostelli', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Kallirhoe', 'Initials': 'K', 'LastName': 'Kourea', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Kyriakou', 'Affiliation': 'Laboratory of Haematology & Blood Bank Unit, ""Attikon"" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Athina', 'Initials': 'A', 'LastName': 'Kypraiou', 'Affiliation': 'Laboratory of Haematology & Blood Bank Unit, ""Attikon"" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Tsoumani', 'Affiliation': 'Department of Pharmaceutical Chemistry, National and Kapodistrian University of Athens, School of Pharmacy, Athens, Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Andreadou', 'Affiliation': 'Department of Pharmaceutical Chemistry, National and Kapodistrian University of Athens, School of Pharmacy, Athens, Greece.'}, {'ForeName': 'Vaia', 'Initials': 'V', 'LastName': 'Lambadiari', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Plotas', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Thymis', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Argirios E', 'Initials': 'AE', 'LastName': 'Tsantes', 'Affiliation': 'Laboratory of Haematology & Blood Bank Unit, ""Attikon"" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}]",Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association,['10.1016/j.fct.2020.111389']
13,32347692,COMPARISON OF VISUAL AND REFRACTIVE OUTCOMES OF TWO TRIFOCAL INTRAOCULAR LENSES.,"PURPOSE


To compare clinical outcomes after cataract surgery and bilateral implantation of two diffractive trifocal toric intraocular lenses (IOLs).
SETTING


Hospital da Luz, Lisbon, Portugal DESIGN:: Double arm, randomized and prospective case series METHODS:: A total of 60 patients were randomly allocated to receive bilateral implantation of either FineVision toric PODFT (PhysIOL) or Acrysof IQ PanOptix toric (Alcon) IOLs. Visual and refractive outcomes, contrast sensitivity, IOL misalignment, and quality of vision outcomes (QoV questionnaire) were evaluated at 3 months postoperatively. Surgically induced astigmatic changes were evaluated by vector analysis.
RESULTS


Each group comprised 30 patients (60 eyes). No significant differences between groups were found regarding uncorrected and corrected distance and near visual outcomes (p≥0.333). Mean postoperative distance-corrected intermediate visual acuity at 60 cm was 0.04 ± 0.09 and 0.09 ± 0.11 logMAR in the PanOptix and PODFT group, respectively (p=0.032). Mean IOL axis misalignment was 1.59 ± 2.15° (PanOptix group) and 1.89 ± 3.31° (PODFT group) (p=0.821). Mean magnitude of error of astigmatic correction was -0.09 and -0.11 D in the PanOptix and PODFT group, respectively (p=0.333). Contrast sensitivity, QoV scores for the presence of photic phenomena, and the level of spectacle independence were similar in both groups (p>0.05).
CONCLUSIONS


Both trifocal toric IOLs allow a complete patient's visual restoration, providing good spectacle independence and good visual quality outcomes. The PanOptix toric IOL provides superior intermediate visual acuity for distances around 60 cm.",2020,No significant differences between groups were found regarding uncorrected and corrected distance and near visual outcomes (p≥0.333).,"[' A total of 60 patients', 'Hospital da Luz, Lisbon, Portugal DESIGN']","['cataract surgery and bilateral implantation of two diffractive trifocal toric intraocular lenses (IOLs', 'bilateral implantation of either FineVision toric PODFT (PhysIOL) or Acrysof IQ PanOptix toric (Alcon) IOLs']","['Mean IOL axis misalignment', 'Mean magnitude of error of astigmatic correction', 'Visual and refractive outcomes, contrast sensitivity, IOL misalignment, and quality of vision outcomes (QoV questionnaire', 'corrected distance and near visual outcomes', 'Contrast sensitivity, QoV scores', 'astigmatic changes', 'Mean postoperative distance-corrected intermediate visual acuity', 'level of spectacle independence']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0032729', 'cui_str': 'Portugal'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1275646', 'cui_str': 'Trifocal glasses'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C1275957', 'cui_str': 'Misalignment'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1690987', 'cui_str': 'Intermediate visual acuity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}]",60.0,0.109203,No significant differences between groups were found regarding uncorrected and corrected distance and near visual outcomes (p≥0.333).,"[{'ForeName': 'Filomena J', 'Initials': 'FJ', 'LastName': 'Ribeiro', 'Affiliation': 'Department of Ophthalmology, Hospital da Luz, Lisbon, Portugal.'}, {'ForeName': 'Tiago B', 'Initials': 'TB', 'LastName': 'Ferreira', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000118']
14,32347699,Evaluation of total corneal power measurements with a new optical biometer.,"PURPOSE


Evaluate the repeatability and validity of total corneal power measurements (TK) obtained with a recently introduced optical biometer (IOL Master 700, Zeiss, Germany) to a Scheimpflug device (Pentacam, Oculus, Germany).
SETTING


Department of Ophthalmology, Ludwig-Maximilians-University, Munich, Germany DESIGN:: Prospective randomized controlled trial METHODS:: Ninety-three eyes of 93 subjects were included. The inclusion criteria were a corneal astigmatism of 3.00 dioptres or less, no prior ocular surgery, no known corneal irregularities and no known dry eyes. All eyes were measured 3 times using the optical biometer and the Scheimpflug device. The results were statistically compared using Bland-Altman, within-subject standard deviation and astigmatism vector analysis.
RESULTS


The repeatability was 0.42 for standard K, 0.40 for TK, 0.45 for TCRP, 0.43 for TNP and 0.39 for SimK. Bland-Altman analysis showed no significant difference between the IOL Master 700´s TK compared to standard K and Pentacam´s SimK, TNP and TCRP, the P value exceeding 0.05 in each case. A difference of >0.5 D between astigmatism measurements between TK and TCRP was found in 10 cases, compared to standard K and TNP with 0 and 2 cases.
CONCLUSIONS


Repeatability of both devices was high, although measurements of meridian show a great variability, suggesting numerous measurements are needed to enhance accuracy. Total corneal refractive power measurements between recently introduced TK and TCRP cannot be used interchangeably. Future studies are necessary to evaluate which measurement will result in a better outcome when respective measurements are used for toric IOL calculations.",2020,"A difference of >0.5 D between astigmatism measurements between TK and TCRP was found in 10 cases, compared to standard K and TNP with 0 and 2 cases.
","['The inclusion criteria were a corneal astigmatism of 3.00 dioptres or less, no prior ocular surgery, no known corneal irregularities and no known dry eyes', ' Ninety-three eyes of 93 subjects were included', 'Department of Ophthalmology, Ludwig-Maximilians-University, Munich, Germany DESIGN']",['total corneal power measurements (TK'],['Total corneal refractive power measurements'],"[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0339682', 'cui_str': 'Regular astigmatism - corneal'}, {'cui': 'C0439484', 'cui_str': 'Diopters'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1705869', 'cui_str': 'Ophthalmic surgery'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C0024081', 'cui_str': ""Ludwig's angina""}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0429520', 'cui_str': 'Refractive power'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",93.0,0.0469384,"A difference of >0.5 D between astigmatism measurements between TK and TCRP was found in 10 cases, compared to standard K and TNP with 0 and 2 cases.
","[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Shajari', 'Affiliation': 'Department of Ophthalmology, Ludwig-Maximilians University, Munich, Germany.'}, {'ForeName': 'Ruven', 'Initials': 'R', 'LastName': 'Sonntag', 'Affiliation': 'Department of Ophthalmology, Ludwig-Maximilians University, Munich, Germany.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Ramsauer', 'Affiliation': 'Department of Ophthalmology, Ludwig-Maximilians University, Munich, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kreutzer', 'Affiliation': 'Department of Ophthalmology, Ludwig-Maximilians University, Munich, Germany.'}, {'ForeName': 'Efstathios', 'Initials': 'E', 'LastName': 'Vounotrypidis', 'Affiliation': 'Department of Ophthalmology, Ludwig-Maximilians University, Munich, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kohnen', 'Affiliation': 'Department of Ophthalmology, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Siegfried', 'Initials': 'S', 'LastName': 'Priglinger', 'Affiliation': 'Department of Ophthalmology, Ludwig-Maximilians University, Munich, Germany.'}, {'ForeName': 'Wolfgang J', 'Initials': 'WJ', 'LastName': 'Mayer', 'Affiliation': 'Department of Ophthalmology, Ludwig-Maximilians University, Munich, Germany.'}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000136']
15,32346816,Agreement Among Paper and Electronic Modes of the EQ-5D-5L.,"INTRODUCTION


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


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


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


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


Overall, our comparisons of the paper, screen-based, and phone-based formats of the EQ-5D-5L provided substantial evidence to support the measurement equivalence of these modes of data collection.",2020,The test-retest results showed mean differences near zero and ICC values > 0.90 for both the index and the EQ VAS scores.,[],['EQ-5D-5L'],"['intraclass correlation coefficients (ICCs', 'EQ VAS scores', 'EQ-5D index scores and EQ VAS scores']",[],[],"[{'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.036839,The test-retest results showed mean differences near zero and ICC values > 0.90 for both the index and the EQ VAS scores.,"[{'ForeName': 'J Jason', 'Initials': 'JJ', 'LastName': 'Lundy', 'Affiliation': 'Outcometrix, 433 Central Avenue, Suite 300, St. Petersburg, FL, 33701, USA. jlundy@outcometrix.com.'}, {'ForeName': 'Stephen Joel', 'Initials': 'SJ', 'LastName': 'Coons', 'Affiliation': 'Patient-Reported Outcome Consortium, Critical Path Institute, Tucson, AZ, USA.'}, {'ForeName': 'Emuella', 'Initials': 'E', 'LastName': 'Flood', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Mira J', 'Initials': 'MJ', 'LastName': 'Patel', 'Affiliation': 'Division of Clinical Outcome Assessment, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, White Oak, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The patient,['10.1007/s40271-020-00419-6']
16,32344167,Umifenovir treatment is not associated with improved outcomes in patients with coronavirus disease 2019: a retrospective study.,"OBJECTIVES


Coronavirus disease 2019 (COVID-19) is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Umifenovir (Arbidol®) is an antiviral drug being used to treat influenza in Russia and China. This study aimed to investigate the effectiveness and safety of umifenovir for COVID-19.
METHODS


A retrospective study was performed in a non-intensive care unit (ICU) ward in Jinyintan Hospital from 2 February 2020 to 20 March 2020. COVID-19 was confirmed by real-time reverse-transcriptase polymerase chain reaction (RT-PCR) assay of pharyngeal swab specimens. The confirmed patients were divided into the umifenovir group and the control group according to the use of umifenovir. The main outcomes were the rate of negative pharyngeal swab tests for SARS-CoV-2 within 1 week after admission and the time for the virus to turn negative. The negativity time of SARS-CoV-2 was defined as the first day of a negative test if the nucleic acid of SARS-CoV-2 was negative for two consecutive tests.
RESULTS


A total of 81 COVID-19 patients were included, with 45 in the umifenovir group and 36 in the control group. Baseline clinical and laboratory characteristics were comparable between the two groups. Thirty-three out of 45 (73%) patients in the umifenovir group tested negative for SARS-CoV-2 within 7 days after admission, the number was 28/36 (78%) in the control group (p 0.19). The median time from onset of symptoms to SARS-CoV-2 turning negative was 18 days (interquartile range (IQR) 12-21) in the umifenovir group and 16 days (IQR 11-21) in the control group (p 0.42). Patients in the umifenovir group had a longer hospital stay than patients in the control group (13 days (IQR 9-17) vs 11 days (IQR 9-14), p 0.04). No deaths or severe adverse reactions were found in both groups.
DISCUSSION


Umifenovir might not improve the prognosis or accelerate SARS-CoV-2 clearance in non-ICU patients. A randomized control clinical trial is needed to assess the efficacy of umifenovir.",2020,"CONCLUSIONS


Umifenovir might not improve the prognosis or accelerate the SARS-CoV-2 clearance in non-ICU patients.","['81 COVID-19 patients were included, with 45 in umifenovir group and 36 in control group', 'non-ICU Ward in Jinyintan Hospital from February 2, 2020 to March 20, 2020', 'patients with coronavirus disease 2019']","['umifenovir', 'Umifenovir treatment', 'Umifenovir (Arbidol®']","['deaths or severe adverse reaction', 'SARS-CoV-2 clearance', 'median time from onset of symtoms to SARS-CoV-2 turning negative', ""negative rate of pharyngeal swab's test for SARS-CoV-2 within 1\xa0week after admission, as well as the duration for virus turning negative"", 'negativity time of SARS-CoV-2', 'longer hospital stay', 'SARS-CoV-2']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0254211', 'cui_str': 'umifenovir'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0254211', 'cui_str': 'umifenovir'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0541749', 'cui_str': 'Does turn'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439056', 'cui_str': 'Throat swab'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",81.0,0.0490309,"CONCLUSIONS


Umifenovir might not improve the prognosis or accelerate the SARS-CoV-2 clearance in non-ICU patients.","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Lian', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Liver Research Centre, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Lin', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China. Electronic address: linqc_fy@126.com.'}]",Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,['10.1016/j.cmi.2020.04.026']
17,32344176,Imagining a positive future reduces cortisol response to awakening and reactivity to acute stress.,"The positive influence of optimism on health is thought to be due in part to a reduced physiological response to stress, as manifested for instance in activity of hypothalamic-pituitary-adrenal (HPA) systems. Results of previous studies support the notion that dispositional optimism can influence diurnal cortisol secretion as well as cortisol reactivity. The aim of the present study was to examine whether induced optimism can similarly affect HPA activity and thereby potentially have beneficial health effects. We assigned 66 university students to either the Best Possible Self (BPS) or an active control condition, respectively entailing two weeks of daily visualization of a positive future or time management exercises. Before and after the intervention, we assessed diurnal cortisol levels, response to awakening (CAR), and reactivity to the Trier Social Stress Task (TSST), as well as optimism, affect, negative cognitions, perceived stress, and threat appraisal. Effects of the BPS intervention were tested with repeated measures ANOVA (psychological outcomes) and multilevel regression (cortisol outcomes). The BPS intervention was associated with decreases in both the CAR and cortisol responses to acute stress. Compared to controls, BPS participants showed decreased worrying and increased positive affect post-intervention; however, they did not show the expected greater increase in optimism. Within-person decreases in worrying were associated with decreased CARs, whereas both decreased worrying and increased PA were linked to attenuated stress reactivity. Results suggest that the BPS intervention can influence HPA axis reactivity, with effects on well-being variables likely mediating the process. More research is needed to determine longer-term neuroendocrine and health effects of such interventions in at-risk as well as healthy populations.",2020,"Compared to controls, BPS participants showed decreased worrying and increased positive affect post-intervention; however, they did not show the expected greater increase in optimism.",['66 university students to either the'],"['BPS intervention', 'Best Possible Self (BPS) or an active control condition, respectively entailing two weeks of daily visualization of a positive future or time management exercises']","['optimism', 'CAR and cortisol responses', 'cortisol response', 'diurnal cortisol levels, response to awakening (CAR), and reactivity to the Trier Social Stress Task (TSST), as well as optimism, affect, negative cognitions, perceived stress, and threat appraisal', 'HPA axis reactivity', 'HPA activity', 'diurnal cortisol secretion']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0206209', 'cui_str': 'Time Management'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0004381', 'cui_str': 'Automobile'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036536', 'cui_str': 'secretion'}]",66.0,0.0181314,"Compared to controls, BPS participants showed decreased worrying and increased positive affect post-intervention; however, they did not show the expected greater increase in optimism.","[{'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Nicolson', 'Affiliation': 'Department of Psychiatry & Neuropsychology, School for Mental Health and Neuroscience, Maastricht University, Universiteitssingel 40, 6229ER Maastricht, the Netherlands. Electronic address: n.nicolson@maastrichtuniversity.nl.'}, {'ForeName': 'Madelon L', 'Initials': 'ML', 'LastName': 'Peters', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, Universiteitssingel 40, 6229ER Maastricht, the Netherlands. Electronic address: madelon.peters@maastrichtuniversity.nl.'}, {'ForeName': 'Yvo M C', 'Initials': 'YMC', 'LastName': 'In den Bosch-Meevissen', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, Universiteitssingel 40, 6229ER Maastricht, the Netherlands.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104677']
18,32347216,Grinding the intaglio surface of yttria partially- and fully-stabilized zirconia polycrystals restorations: Effect on their fatigue behavior.,"This study evaluated the effects of diamond bur grinding the intaglio surface of second (yttria partially-stabilized zirconia polycrystals, PSZ) and third-generation zirconia (fully-stabilized zirconia polycrystals, FSZ) adhesively cemented to dentin analogue substrate on the fatigue failure load, cycle number until failure, surface micromorphology and phase transformation. Disc-shaped specimens were produced from second (Katana ML-HT, Kuraray) and third-generation zirconia (Katana STML, Kuraray) and randomly allocated (n = 15) into two groups according to the intaglio surface treatment: Control - Ctrl (without grinding); Grinding - Gr (grinding at the center of the intaglio surface). The ceramic discs were adhesively cemented (Multilink Automix System) onto dentin analogue discs. Fatigue tests were executed by the step-stress method. The obtained data were analyzed by Kaplan Meier and Mantel-Cox tests. In addition, surface topography, roughness, phase transformation and fractography analyses were performed. SEM analysis showed that grinding increased the surface roughness and introduced defects in zirconia from both generations. Grinding increased the fatigue failure load, number of cycles to failure and survival rates of the second-generation zirconia statistically (control: 1373.33 N < grinding: 1600 N), while these same outcomes were reduced by grinding for the third-generation zirconia significantly (control: 766.67 N > grinding: 620 N). Thus, clinical adjustments with diamond burs damage the fatigue behavior of adhesively cemented third-generation zirconia.",2020,"Grinding increased the fatigue failure load, number of cycles to failure and survival rates of the second-generation zirconia statistically (control: 1373.33 ",[],"['intaglio surface treatment: Control - Ctrl (without grinding); Grinding - Gr (grinding at the center of the intaglio surface', 'diamond bur grinding the intaglio surface of second (yttria partially-stabilized zirconia polycrystals, PSZ) and third-generation zirconia (fully-stabilized zirconia polycrystals, FSZ']","['surface roughness and introduced defects in zirconia', 'Fatigue tests', 'fatigue failure load, number of cycles to failure and survival rates', 'fatigue behavior']",[],"[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0185051', 'cui_str': 'Removal by grinding'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0057717', 'cui_str': 'Diamond'}, {'cui': 'C0700351', 'cui_str': 'Bur'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0292957', 'cui_str': 'yttria'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0079411', 'cui_str': 'Generations'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C1292748', 'cui_str': 'Introduces'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0215012,"Grinding increased the fatigue failure load, number of cycles to failure and survival rates of the second-generation zirconia statistically (control: 1373.33 ","[{'ForeName': 'Camila Pauleski', 'Initials': 'CP', 'LastName': 'Zucuni', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, State of Rio Grande do Sul, Brazil. Electronic address: camila-svs@hotmail.com.'}, {'ForeName': 'Bruna Dias', 'Initials': 'BD', 'LastName': 'Ilha', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, State of Rio Grande do Sul, Brazil. Electronic address: brunailha2@hotmail.com.'}, {'ForeName': 'Michele Mirian', 'Initials': 'MM', 'LastName': 'May', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, State of Rio Grande do Sul, Brazil. Electronic address: mmayodontologia@gmail.com.'}, {'ForeName': 'Liliana Gressler', 'Initials': 'LG', 'LastName': 'May', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, State of Rio Grande do Sul, Brazil. Electronic address: liligmay@gmail.com.'}, {'ForeName': 'Luiz Felipe', 'Initials': 'LF', 'LastName': 'Valandro', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, State of Rio Grande do Sul, Brazil. Electronic address: valandrolf@gmail.com.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2020.103800']
19,32344934,Lipidomics Reveals Reduced Inflammatory Lipid Species and Storage Lipids after Switching from EFV/FTC/TDF to RPV/FTC/TDF: A Randomized Open-Label Trial.,"HIV and antiretroviral therapy affect lipid metabolism. Lipidomics quantifies several individual species that are overlooked using conventional biochemical analyses, outperforming traditional risk equations. We aimed to compare the plasma lipidomic profile of HIV patients taking efavirenz (EFV) or rilpivirine (RPV). Patients ≥ 18 years old on EFV co-formulated with emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) with HIV-RNA < 50 copies/mL for ≥6 months were randomized to continue EFV/FTC/TDF (n = 14) or switch to RPV/FTC/TDF (n =15). Lipidomic analyses conducted by mass spectrometry (MS) were performed at baseline and after 12 and 24 weeks. OWLiver ®  Care and OWLiver ®  tests were performed to estimate the presence of fatty liver disease (NAFLD). No significant differences (83% male, median age 44 years, 6 years receiving EFV/FTC/TDF, CD4 +  count 740 cells/mm 3 , TC 207 [57 HDL-C/133 LDL-C] mg/dL, TG 117 mg/dL) were observed between the groups at baseline. Significant reductions in plasma lipids and lipoproteins but increased circulating bilirubin concentrations were observed in patients who switched to RPV/FTC/TDF. Patients on RPV/FTC/TDF showed a decrease in the global amount of storage lipids (-0.137 log 2  [fold-change] EFV vs. 0.059 log 2  [fold-change] RPV) but an increase in lysophosphatidylcholines (LPCs) and total steroids. Compared with EFV, RPV increased metabolites with anti-inflammatory properties and reduced the repository of specific lipotoxic lipids.",2020,Significant reductions in plasma lipids and lipoproteins but increased circulating bilirubin concentrations were observed in patients who switched to RPV/FTC/TDF.,"[' 50 copies/mL for ≥6 months', 'Patients ≥ 18 years old on EFV co-formulated with', 'HIV patients taking']","['TDF', 'emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) with HIV-RNA', 'RPV/FTC/TDF', 'efavirenz (EFV) or rilpivirine (RPV', 'continue EFV/FTC/TDF']","['Inflammatory Lipid Species and Storage Lipids', 'plasma lipids and lipoproteins', 'repository of specific lipotoxic lipids', 'global amount of storage lipids ', 'circulating bilirubin concentrations', 'lysophosphatidylcholines (LPCs) and total steroids']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C1566826', 'cui_str': 'Rilpivirine'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0427734', 'cui_str': 'Bilirubin concentration, test strip measurement'}, {'cui': 'C0024360', 'cui_str': 'Lysolecithin'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}]",,0.0351108,Significant reductions in plasma lipids and lipoproteins but increased circulating bilirubin concentrations were observed in patients who switched to RPV/FTC/TDF.,"[{'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Curran', 'Affiliation': ""Infectious Diseases Department, Hospital Universitari Vall d'Hebron, 08035 Barcelona, Spain.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rull', 'Affiliation': 'Hospital Universitari de Tarragona Joan XXIII, IISPV, Universitat Rovira i Virgili, 43005 Tarragona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Navarro', 'Affiliation': ""Infectious Diseases Department, Hospital Universitari Vall d'Hebron, 08035 Barcelona, Spain.""}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Vidal-González', 'Affiliation': ""Vall d'Hebron Institut de Recerca (VHIR), 085035 Barcelona, Spain.""}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Martin-Castillo', 'Affiliation': ""Vall d'Hebron Institut de Recerca (VHIR), 085035 Barcelona, Spain.""}, {'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Burgos', 'Affiliation': ""Infectious Diseases Department, Hospital Universitari Vall d'Hebron, 08035 Barcelona, Spain.""}, {'ForeName': 'Vicenç', 'Initials': 'V', 'LastName': 'Falcó', 'Affiliation': ""Infectious Diseases Department, Hospital Universitari Vall d'Hebron, 08035 Barcelona, Spain.""}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Ribera', 'Affiliation': ""Infectious Diseases Department, Hospital Universitari Vall d'Hebron, 08035 Barcelona, Spain.""}, {'ForeName': 'Ariadna', 'Initials': 'A', 'LastName': 'Torrella', 'Affiliation': ""Vall d'Hebron Institut de Recerca (VHIR), 085035 Barcelona, Spain.""}, {'ForeName': 'Bibiana', 'Initials': 'B', 'LastName': 'Planas', 'Affiliation': ""Vall d'Hebron Institut de Recerca (VHIR), 085035 Barcelona, Spain.""}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Peraire', 'Affiliation': 'Hospital Universitari de Tarragona Joan XXIII, IISPV, Universitat Rovira i Virgili, 43005 Tarragona, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Crespo', 'Affiliation': 'Internal Medicine Department. Complexo Hospitalario Universitario de Vigo; IIS Galicia Sur, 36312 Vigo, Spain.'}]",Journal of clinical medicine,['10.3390/jcm9051246']
20,32345650,Using the BRAVO Risk Engine to Predict Cardiovascular Outcomes in Clinical Trials With Sodium-Glucose Transporter 2 Inhibitors.,"OBJECTIVE


This study evaluated the ability of the Building, Relating, Assessing, and Validating Outcomes (BRAVO) risk engine to accurately project cardiovascular outcomes in three major clinical trials-BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME), Canagliflozin Cardiovascular Assessment Study (CANVAS), and Dapagliflozin Effect on Cardiovascular Events-Thrombolysis in Myocardial Infarction (DECLARE-TIMI 58) trial-on sodium-glucose cotransporter 2 inhibitors (SGLT2is) to treat patients with type 2 diabetes.
RESEARCH DESIGN AND METHODS


Baseline data from the publications of the three trials were obtained and entered into the BRAVO model to predict cardiovascular outcomes. Projected benefits of reducing risk factors of interest (A1C, systolic blood pressure [SBP], LDL, or BMI) on cardiovascular events were evaluated, and simulated outcomes were compared with those observed in each trial.
RESULTS


BRAVO achieved the best prediction accuracy when simulating outcomes of the CANVAS and DECLARE-TIMI 58 trials. For EMPA-REG OUTCOME, a mild bias was observed (∼20%) in the prediction of mortality and angina. The effect of risk reduction on outcomes in treatment versus placebo groups predicted by the BRAVO model strongly correlated with the observed effect of risk reduction on the trial outcomes as published. Finally, the BRAVO engine revealed that most of the clinical benefits associated with SGLT2i treatment are through A1C control, although reductions in SBP and BMI explain a proportion of the observed decline in cardiovascular events.
CONCLUSIONS


The BRAVO risk engine was effective in predicting the benefits of SGLT2is on cardiovascular health through improvements in commonly measured risk factors, including A1C, SBP, and BMI. Since these benefits are individually small, the use of the complex, dynamic BRAVO model is ideal to explain the cardiovascular outcome trial results.",2020,"The BRAVO risk engine was effective in predicting the benefits of SGLT2is on cardiovascular health through improvements in commonly measured risk factors, including A1C, SBP, and BMI.","['patients with type 2 diabetes', 'Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME']","['BI 10773 (Empagliflozin', 'placebo', 'sodium-glucose cotransporter 2 inhibitors (SGLT2is']","['mortality and angina', 'Canagliflozin Cardiovascular Assessment Study (CANVAS), and Dapagliflozin Effect on Cardiovascular Events-Thrombolysis in Myocardial Infarction', 'A1C, SBP, and BMI', 'risk factors of interest (A1C, systolic blood pressure [SBP], LDL, or BMI) on cardiovascular events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0208940', 'cui_str': 'REG1A protein, human'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C3490349', 'cui_str': 'BI 10773'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}]",,0.0433696,"The BRAVO risk engine was effective in predicting the benefits of SGLT2is on cardiovascular health through improvements in commonly measured risk factors, including A1C, SBP, and BMI.","[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Shao', 'Affiliation': 'Department of Pharmaceutical Outcomes and Policy, University of Florida College of Pharmacy, Gainesville, FL.'}, {'ForeName': 'Lizheng', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Tulane University School of Public Health and Tropical Medicine, New Orleans, LA.'}, {'ForeName': 'Vivian A', 'Initials': 'VA', 'LastName': 'Fonseca', 'Affiliation': 'Tulane University School of Medicine, New Orleans, LA vfonseca@tulane.edu.'}]",Diabetes care,['10.2337/dc20-0227']
21,32344842,The Effects of Vitamin D Supplementation on Lipid and Inflammatory Profile of Healthy Adolescent Boys: A Randomized Controlled Trial.,"BACKGROUND


Deficiency of vitamin D, an anti-inflammatory micronutrient with some favorable effects on lipid profiles, has been found to be highly prevalent in adolescents. We aimed to investigate the effect of a school-based vitamin D supplementation regimen on the correction of vitamin D deficiency as well as lipid and inflammatory profiles of healthy adolescent boys.
METHODS


In this randomized single-blind placebo-controlled trial, seventy-one healthy adolescent boys (age 17 years old) were recruited from one high school in Tehran, Iran, and randomly assigned to two groups. The supplement group received vitamin D pearls at a dose of 50,000 IU monthly for 6 months, this dose is indeed defined by the Ministry of Health in Iran for a potential national school-based vitamin D supplementation program. The other group was given placebo pearls for the same duration. Before and after the treatment, the serum levels of 25-hydroxy vitamin D (25(OH) D), parathyroid hormone (PTH), retinol, lead (Pb), the lipid profile and the inflammatory biomarkers were measured and compared.
RESULTS


Between-groups statistical analysis showed that a dose (50,000 IU/month) vitamin D significantly increased the serum levels of 25-hydroxyvitamin D (25 (OH) D) ( p  < 0.001) and decreased serum levels of PTH ( p  = 0.003). No significant change was observed in serum levels of retinol and Pb. Between-group analysis revealed that the serum levels of TG (P = 0.001) decreased while an increase in serum levels of HDL ( p  = 0.021) was observed ( p  < 0.05). Both the within- and between-group analysis showed that serum tumor necrosis factor receptor 2 (TNFR2) concentration declined while serum interleukin-10 (IL-10) increased in response to vitamin D supplementation ( p  < 0.05).
CONCLUSION


A supplementation regimen of (50,000 IU/month) vitamin D in a context with high rates of vitamin deficiency has shown positive impacts on the serum vitamin D, lipid profile and inflammatory biomarkers in healthy adolescent boys.",2020,Between-group analysis revealed that the serum levels of TG (P = 0.001) decreased while an increase in serum levels of HDL ( p  = 0.021) was observed ( p  < 0.05).,"['Healthy Adolescent Boys', 'seventy-one healthy adolescent boys (age 17 years old) were recruited from one high school in Tehran, Iran', 'healthy adolescent boys']","['vitamin D pearls', 'Vitamin D Supplementation', 'vitamin D', 'school-based vitamin D supplementation regimen', 'placebo']","['serum levels of 25-hydroxyvitamin D (25 (OH) D', 'serum levels of PTH', 'serum levels of TG', 'serum tumor necrosis factor receptor 2 (TNFR2) concentration declined while serum interleukin-10 (IL-10', 'serum levels of retinol and Pb', 'serum vitamin D, lipid profile and inflammatory biomarkers', 'serum levels of 25-hydroxy vitamin D (25(OH) D), parathyroid hormone (PTH), retinol, lead (Pb), the lipid profile and the inflammatory biomarkers', 'serum levels of HDL']","[{'cui': 'C0686747', 'cui_str': 'Well adolescent'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0255813', 'cui_str': 'Lymphocyte antigen CD120B'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}]",71.0,0.226066,Between-group analysis revealed that the serum levels of TG (P = 0.001) decreased while an increase in serum levels of HDL ( p  = 0.021) was observed ( p  < 0.05).,"[{'ForeName': 'Amirhossein', 'Initials': 'A', 'LastName': 'Yarparvar', 'Affiliation': 'School of Nutrition, University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Elmadfa', 'Affiliation': 'School of Nutrition, University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Abolghasem', 'Initials': 'A', 'LastName': 'Djazayery', 'Affiliation': 'School of Nutrition and Dietetics, Tehran University of Medical Science, Tehran 14155/6117, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Abdollahi', 'Affiliation': 'Nutrition Department of the Ministry of health and Medical Education, Tehran 1467664961, Iran.'}, {'ForeName': 'Forouzan', 'Initials': 'F', 'LastName': 'Salehi', 'Affiliation': 'Deputy Director of Family Health Department of the Ministry of Health and Medical Education, Tehran 1467664961, Iran.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Heshmat', 'Affiliation': 'Ramin Heshmat, Tehran University of Medical Sciences, Tehran 141675395, Iran.'}]",Nutrients,['10.3390/nu12051213']
22,32345653,Screening and Treatment Outcomes in Adults and Children With Type 1 Diabetes and Asymptomatic Celiac Disease: The CD-DIET Study.,"OBJECTIVE


To describe celiac disease (CD) screening rates and glycemic outcomes of a gluten-free diet (GFD) in patients with type 1 diabetes who are asymptomatic for CD.
RESEARCH DESIGN AND METHODS


Asymptomatic patients (8-45 years) were screened for CD. Biopsy-confirmed CD participants were randomized to GFD or gluten-containing diet (GCD) to assess changes in HbA 1c  and continuous glucose monitoring over 12 months.
RESULTS


Adults had higher CD-seropositivity rates than children (6.8% [95% CI 4.9-8.2%,  N  = 1,298] vs. 4.7% [95% CI 3.4-5.9%,  N  = 1,089],  P  = 0.035) with lower rates of prior CD screening (6.9% vs. 44.2%,  P  < 0.0001). Fifty-one participants were randomized to a GFD ( N  = 27) or GCD ( N  = 24). No HbA 1c  differences were seen between the groups (+0.14%, 1.5 mmol/mol; 95% CI -0.79 to 1.08;  P  = 0.76), although greater postprandial glucose increases (4-h +1.5 mmol/L; 95% CI 0.4-2.7;  P  = 0.014) emerged with a GFD.
CONCLUSIONS


CD is frequently observed in asymptomatic patients with type 1 diabetes, and clinical vigilance is warranted with initiation of a GFD.",2020,"RESULTS


Adults had higher CD-seropositivity rates than children (6.8% [95% CI 4.9-8.2%,  N  = 1,298] vs. 4.7% [95% CI 3.4-5.9%,  N  = 1,089],  P  = 0.035) with lower rates of prior CD screening (6.9% vs. 44.2%,  P  < 0.0001).","['patients with type 1 diabetes who are asymptomatic for CD', 'asymptomatic patients with type 1 diabetes', 'Biopsy-confirmed CD participants', 'Asymptomatic patients (8-45 years) were screened for CD', 'Adults and Children With Type 1 Diabetes and Asymptomatic Celiac Disease']","['GCD', 'GFD or gluten-containing diet (GCD', 'GFD', 'gluten-free diet (GFD']","['rates of prior CD screening', 'postprandial glucose increases', 'CD-seropositivity rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0007570', 'cui_str': 'Celiac disease'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1272312', 'cui_str': 'Celiac disease screen'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C2362561', 'cui_str': 'Gluten'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0344351', 'cui_str': 'Gluten free diet'}]","[{'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0007570', 'cui_str': 'Celiac disease'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0860803', 'cui_str': 'Glucose increased'}]",51.0,0.0463207,"RESULTS


Adults had higher CD-seropositivity rates than children (6.8% [95% CI 4.9-8.2%,  N  = 1,298] vs. 4.7% [95% CI 3.4-5.9%,  N  = 1,089],  P  = 0.035) with lower rates of prior CD screening (6.9% vs. 44.2%,  P  < 0.0001).","[{'ForeName': 'Farid H', 'Initials': 'FH', 'LastName': 'Mahmud', 'Affiliation': 'Division of Endocrinology, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada farid.mahmud@sickkids.ca.'}, {'ForeName': 'Antoine B M', 'Initials': 'ABM', 'LastName': 'Clarke', 'Affiliation': 'Division of Endocrinology, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Kariym C', 'Initials': 'KC', 'LastName': 'Joachim', 'Affiliation': 'Division of Endocrinology, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Assor', 'Affiliation': 'Division of Endocrinology, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'McDonald', 'Affiliation': ""Division of Endocrinology and Metabolism, St. Joseph's Health Care, London Health Sciences Centre, Western University, London, Ontario, Canada.""}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saibil', 'Affiliation': 'Division of Gastroenterology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Lochnan', 'Affiliation': 'Department of Endocrinology, The Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'Zubin', 'Initials': 'Z', 'LastName': 'Punthakee', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Amish', 'Initials': 'A', 'LastName': 'Parikh', 'Affiliation': 'Division of Endocrinology, Trillium Health Partners, Toronto, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Advani', 'Affiliation': ""Division of Endocrinology, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Baiju R', 'Initials': 'BR', 'LastName': 'Shah', 'Affiliation': 'Division of Endocrinology and Metabolism, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Perkins', 'Affiliation': 'Division of Endocrinology and Metabolism, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Caroline S', 'Initials': 'CS', 'LastName': 'Zuijdwijk', 'Affiliation': ""Division of Endocrinology and Metabolism, University of Ottawa, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.""}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Mack', 'Affiliation': ""Division of Gastroenterology, Hepatology and Nutrition, University of Ottawa, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.""}, {'ForeName': 'Dror', 'Initials': 'D', 'LastName': 'Koltin', 'Affiliation': 'Division of Endocrinology, Trillium Health Partners, Toronto, Ontario, Canada.'}, {'ForeName': 'Emilia N', 'Initials': 'EN', 'LastName': 'De Melo', 'Affiliation': 'Division of Endocrinology, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Hsieh', 'Affiliation': 'Department of Pathology, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Geetha', 'Initials': 'G', 'LastName': 'Mukerji', 'Affiliation': ""Division of Endocrinology, Women's College Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Gilbert', 'Affiliation': 'Division of Endocrinology and Metabolism, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Bax', 'Affiliation': ""Pediatric Gastroenterology, Department of Pediatrics, Children's Hospital, London Health Sciences Centre, Western University, London, Ontario, Canada.""}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'Lawson', 'Affiliation': ""Division of Endocrinology and Metabolism, University of Ottawa, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Cino', 'Affiliation': 'Division of Gastroenterology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Melanie D', 'Initials': 'MD', 'LastName': 'Beaton', 'Affiliation': 'Division of Gastroenterology, London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Navaaz A', 'Initials': 'NA', 'LastName': 'Saloojee', 'Affiliation': 'Department of Gastroenterology, The Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Lou', 'Affiliation': 'JDRF, New York, NY.'}, {'ForeName': 'Patricia H', 'Initials': 'PH', 'LastName': 'Gallego', 'Affiliation': ""Division of Endocrinology, Children's Hospital, London Health Sciences Centre, Western University, London, Ontario, Canada.""}, {'ForeName': 'Premysl', 'Initials': 'P', 'LastName': 'Bercik', 'Affiliation': 'Department of Gastroenterology, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Houlden', 'Affiliation': 'Department of Endocrinology, Kingston General Hospital, Kingston, Ontario, Canada.'}, {'ForeName': 'Ronnie', 'Initials': 'R', 'LastName': 'Aronson', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Kirsch', 'Affiliation': 'Division of Endocrinology, Markham-Stouffville Hospital, Markham, Ontario, Canada.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Paterson', 'Affiliation': 'Department of Gastroenterology, Kingston General Hospital, Kingston, Ontario, Canada.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Marcon', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}]",Diabetes care,['10.2337/dc19-1944']
23,32345685,A Triadic Intervention for Adolescent Sexual Health: A Randomized Clinical Trial.,"OBJECTIVES


In this study, we evaluate the efficacy of Families Talking Together (FTT), a triadic intervention to reduce adolescent sexual risk behavior.
METHODS


Adolescents aged 11 to 14 and their female caregivers were recruited from a pediatric clinic; 900 families were enrolled; 84 declined. Families were randomly assigned to FTT or 1 of 2 control conditions. The FTT triadic intervention consisted of a 45-minute face-to-face session for mothers, health care provider endorsement of intervention content, printed materials for families, and a booster call for mothers. The primary outcomes were ever having had vaginal intercourse, sexual debut within the past 12 months, and condom use at last sexual intercourse. Assessments occurred at baseline, 3 months post baseline, and 12 months post baseline.
RESULTS


Of enrolled families, 73.4% identified as Hispanic, 20.4% as African American, and 6.2% as mixed race. Mean maternal age was 38.8 years, and mean adolescent grade was seventh grade. At the 12-month follow-up, 5.2% of adolescents in the experimental group reported having had sexual intercourse, compared with 18% of adolescents in the control groups ( P  < .05). In the experimental group, 4.7% of adolescents reported sexual debut within the past 12 months, compared with 14.7% of adolescents in the control group ( P  < .05). In the experimental group, 74.2% of sexually active adolescents indicated using a condom at last sexual intercourse, compared with 49.1% of adolescents in the control group ( P  < .05).
CONCLUSIONS


This research suggests that the FTT triadic intervention is efficacious in delaying sexual debut and reducing sexual risk behavior among adolescents.",2020,This research suggests that the FTT triadic intervention is efficacious in delaying sexual debut and reducing sexual risk behavior among adolescents.,"['Mean maternal age was 38.8 years, and mean adolescent grade was seventh grade', 'Adolescent Sexual Health', 'Of enrolled families, 73.4% identified as Hispanic, 20.4% as African American, and 6.2% as mixed race', 'Adolescents aged 11 to 14 and their female caregivers were recruited from a pediatric clinic; 900 families were enrolled; 84 declined', 'adolescents']","['FTT triadic intervention', 'FTT', 'triadic intervention', 'Triadic Intervention', 'Families Talking Together']","['sexual intercourse', 'sexual debut', 'ever having had vaginal intercourse, sexual debut within the past 12 months, and condom use at last sexual intercourse', 'sexual risk behavior']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0024915', 'cui_str': 'Maternal age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205441', 'cui_str': 'Seventh'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C3839701', 'cui_str': 'Pediatric clinic'}, {'cui': 'C4517900', 'cui_str': '900'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}]",900.0,0.0590979,This research suggests that the FTT triadic intervention is efficacious in delaying sexual debut and reducing sexual risk behavior among adolescents.,"[{'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Guilamo-Ramos', 'Affiliation': 'Center for Latino Adolescent and Family Health, New York University, New York, New York; vincent.ramos@nyu.edu.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Benzekri', 'Affiliation': 'Center for Latino Adolescent and Family Health, New York University, New York, New York.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Thimm-Kaiser', 'Affiliation': 'Center for Latino Adolescent and Family Health, New York University, New York, New York.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Dittus', 'Affiliation': 'Division of Sexually Transmitted Disease Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Yumary', 'Initials': 'Y', 'LastName': 'Ruiz', 'Affiliation': 'Center for Latino Adolescent and Family Health, New York University, New York, New York.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Cleland', 'Affiliation': 'New York University Langone Health, New York, New York; and.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'McCoy', 'Affiliation': 'Morris Heights Health Center, Bronx, New York.'}]",Pediatrics,['10.1542/peds.2019-2808']
24,32348263,Effect of an mHealth Intervention Using a Pedometer App With Full In-Person Counseling on Body Composition of Overweight Adults: Randomized Controlled Weight Loss Trial.,"BACKGROUND


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


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


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


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


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


ClinicalTrials.gov NCT03845478; https://clinicaltrials.gov/ct2/show/NCT03845478.",2020,"The results show that regardless of sex or age, prescribing walking increased the number of steps per day by 4806 step on average (standardized beta coefficient=-0.813, SE=427.586, t=-11.242, P<.001).
","['Overweight Adults', 'Overweight adults (n=98; mean body mass index 32.53 [SD 4.92] kg/m2', 'adults', 'overweight or obese patients', 'adult patients with excess weight or obesity']",['mHealth Intervention Using a Pedometer App With Full'],[],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]",[],,0.0631852,"The results show that regardless of sex or age, prescribing walking increased the number of steps per day by 4806 step on average (standardized beta coefficient=-0.813, SE=427.586, t=-11.242, P<.001).
","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Hernández-Reyes', 'Affiliation': 'Universidad de Córdoba, Córdoba, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Cámara-Martos', 'Affiliation': 'Universidad de Córdoba, Córdoba, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Molina-Luque', 'Affiliation': 'Universidad de Córdoba, Córdoba, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Moreno-Rojas', 'Affiliation': 'Universidad de Córdoba, Córdoba, Spain.'}]",JMIR mHealth and uHealth,['10.2196/16999']
25,30232416,Ghrelin is impacted by the endogenous circadian system and by circadian misalignment in humans.,"The human circadian system regulates hunger independently of behavioral factors, resulting in a trough in the biological morning and a peak in the biological evening. However, the role of the only known orexigenic hormone, ghrelin, in this circadian rhythm is unknown. Furthermore, although shift work is an obesity risk factor, the separate effects of the endogenous circadian system, the behavioral cycle, and circadian misalignment on ghrelin has not been systematically studied. Here we show-by using two 8-day laboratory protocols-that circulating active (acylated) ghrelin levels are significantly impacted by endogenous circadian phase in healthy adults. Active ghrelin levels were higher in the biological evening than the biological morning (fasting +15.1%, P = 0.0001; postprandial +10.4%, P = 0.0002), consistent with the circadian variation in hunger (P = 0.028). Moreover, circadian misalignment itself (12-h behavioral cycle inversion) increased postprandial active ghrelin levels (+5.4%; P = 0.04). While not significantly influencing hunger (P > 0.08), circadian misalignment increased appetite for energy-dense foods (all P < 0.05). Our results provide possible mechanisms for the endogenous circadian rhythm in hunger, as well as for the increased risk of obesity among shift workers.",2019,"While not significantly influencing hunger (P > 0.08), circadian misalignment increased appetite for energy-dense foods (all P < 0.05).",['healthy adults'],[],"['Active ghrelin levels', 'postprandial active ghrelin levels', 'circadian variation in hunger', 'hunger']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]",[],"[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}]",,0.0482443,"While not significantly influencing hunger (P > 0.08), circadian misalignment increased appetite for energy-dense foods (all P < 0.05).","[{'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'Qian', 'Affiliation': ""Medical Chronobiology Program, Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, USA. jqian@bwh.harvard.edu.""}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Morris', 'Affiliation': ""Medical Chronobiology Program, Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Caputo', 'Affiliation': ""Medical Chronobiology Program, Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Garaulet', 'Affiliation': 'Department of Physiology, Chronobiology Laboratory, University of Murcia and Research Biomedical Institute of Murcia, Murcia, Spain.'}, {'ForeName': 'Frank A J L', 'Initials': 'FAJL', 'LastName': 'Scheer', 'Affiliation': ""Medical Chronobiology Program, Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, USA. fscheer@bwh.harvard.edu.""}]",International journal of obesity (2005),['10.1038/s41366-018-0208-9']
26,32345760,Esophageal Pressure Versus Gas Exchange to Set PEEP During Intraoperative Ventilation.,"BACKGROUND


Pneumoperitoneum and Trendelenburg position affect respiratory system mechanics and oxygenation during elective pelvic robotic surgery. The primary aim of this randomized pilot study was to compare the effects of a conventional low tidal volume ventilation with PEEP guided by gas exchange (V Gas-guided ) versus low tidal volume ventilation tailoring PEEP according to esophageal pressure (V Pes-guided ) on oxygenation and respiratory mechanics during elective pelvic robotic surgery.
METHODS


This study was conducted in a single-center tertiary hospital between September 2017 and January 2019. Forty-nine adult patients scheduled for elective pelvic robotic surgery were screened; 28 subjects completed the full analysis. Exclusion criteria were American Society of Anesthesiologists physical status ≥ 3, contraindications to nasogastric catheter placement, and pregnancy. After dedicated naso/orogastric catheter insertion, subjects were randomly assigned to V Gas-guided  ([Formula: see text] and PEEP set to achieve [Formula: see text] > 94%) or V Pes-guided  (PEEP tailored to equalize end-expiratory transpulmonary pressure). Oxygenation ([Formula: see text]/[Formula: see text]) was evaluated (1) at randomization, after pneumoperitoneum and Trendelenburg application; (2) at 60 min; (3) at 120 min following randomization; and (4) at end of surgery. Respiratory mechanics were assessed during the duration of the study.
RESULTS


Compared to V Gas-guided , oxygenation was higher with V Pes-guided  at 60 min (388 ± 90 vs 308 ± 95 mm Hg,  P  = .02), at 120 min after randomization (400 ± 90 vs 308 ± 81 mm Hg,  P  = .008), and at the end of surgery (402 ± 95 vs 312 ± 95 mm Hg,  P  = .009). Respiratory system elastance was lower with V Pes-guided  compared to V Gas-guided  at 20 min (24.2 ± 7.3 vs 33.4 ± 10.7 cm H 2 O/L,  P  = .001) and 60 min (24.1 ± 5.4 vs 31.9 ± 8.5 cm H 2 O/L,  P  = .006) from randomization.
CONCLUSIONS


Oxygenation and respiratory system mechanics were improved when applying a ventilatory strategy tailoring PEEP to equalize expiratory transpulmonary pressure in subjects undergoing pelvic robotic surgery compared to a V Gas-guided  approach. (ClinicalTrials.gov registration NCT03153592).",2020,"Compared to V Gas-guided , oxygenation was higher with V Pes-guided  at 60 min (388 ± 90 vs 308 ± 95 mm Hg,  P  = .02), at 120 min after randomization (400 ± 90 vs 308 ± 81 mm Hg,  P  = .008), and at the end of surgery (402 ± 95 vs 312 ± 95 mm Hg,  P  = .009).","['subjects undergoing pelvic robotic surgery', 'single-center tertiary hospital between September 2017 and January 2019', 'Forty-nine adult patients scheduled for elective pelvic robotic surgery were screened; 28 subjects completed the full analysis', 'elective pelvic robotic surgery']","['Esophageal Pressure Versus Gas Exchange to Set PEEP', 'V Gas-guided  ([Formula: see text] and PEEP set to achieve [Formula: see text] > 94%) or V Pes-guided  (PEEP tailored to equalize end-expiratory transpulmonary pressure', 'conventional low tidal volume ventilation with PEEP guided by gas exchange (V Gas-guided ) versus low tidal volume ventilation tailoring PEEP']","['Respiratory mechanics', 'Respiratory system elastance']","[{'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0232531', 'cui_str': 'Esophageal pressure'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0442700', 'cui_str': 'End-expiration'}, {'cui': 'C0442377', 'cui_str': 'Transpulmonary artery approach'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0035237', 'cui_str': 'Structure of respiratory system'}]",49.0,0.116304,"Compared to V Gas-guided , oxygenation was higher with V Pes-guided  at 60 min (388 ± 90 vs 308 ± 95 mm Hg,  P  = .02), at 120 min after randomization (400 ± 90 vs 308 ± 81 mm Hg,  P  = .008), and at the end of surgery (402 ± 95 vs 312 ± 95 mm Hg,  P  = .009).","[{'ForeName': 'Gianmaria', 'Initials': 'G', 'LastName': 'Cammarota', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Maggiore della Carità University Hospital, Novara, Italy. gmcamma@gmail.com.'}, {'ForeName': 'Gianluigi', 'Initials': 'G', 'LastName': 'Lauro', 'Affiliation': 'Department of Translational Medicine, Eastern Piedmont University, Novara, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Sguazzotti', 'Affiliation': 'Department of Translational Medicine, Eastern Piedmont University, Novara, Italy.'}, {'ForeName': 'Iolanda', 'Initials': 'I', 'LastName': 'Mariano', 'Affiliation': 'Department of Translational Medicine, Eastern Piedmont University, Novara, Italy.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Perucca', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Maggiore della Carità University Hospital, Novara, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Messina', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Humanitas Research Hospital, Milan, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Zanoni', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Maggiore della Carità University Hospital, Novara, Italy.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Garofalo', 'Affiliation': 'Department of Medical and Surgical Science, Magna Graecia University, Catanzaro, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bruni', 'Affiliation': 'Department of Medical and Surgical Science, Magna Graecia University, Catanzaro, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Della Corte', 'Affiliation': 'Department of Translational Medicine, Eastern Piedmont University, Novara, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Navalesi', 'Affiliation': 'Department of Medical and Surgical Science, Magna Graecia University, Catanzaro, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Bignami', 'Affiliation': 'Anesthesiology, Critical Care and Pain Medicine Division, Department of Medicine and Surgery. University of Parma, Parma, Italy.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Vaschetto', 'Affiliation': 'Department of Translational Medicine, Eastern Piedmont University, Novara, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Mojoli', 'Affiliation': 'Anesthesia and Intensive Care Department, Policlinico S. Matteo IRCCS Foundation, Pavia, Italy.'}]",Respiratory care,['10.4187/respcare.07238']
27,32367115,Corrigendum for O'Connor et al. Nutrient enrichment of human milk with human and bovine milk-based fortifiers for infants born weighing < 1250 g: a randomized clinical trial. Am J Clin Nutr 2018;108:108-16.,,2020,,['human milk with human and bovine milk-based fortifiers for infants born weighing\xa0'],[],[],"[{'cui': 'C0026140', 'cui_str': 'Breast milk'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}]",[],[],,0.0313816,,[],The American journal of clinical nutrition,['10.1093/ajcn/nqaa042']
28,32348280,A Pedometer-Guided Physical Activity Intervention for Obese Pregnant Women (the Fit MUM Study): Randomized Feasibility Study.,"BACKGROUND


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


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


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


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


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


Australian and New Zealand Clinical Trials Registry ACTRN12617000038392; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370884.",2020,"Estimated mean baseline activity levels were 14.5 active min/day and 5455 steps/day, with no significant differences found in activity levels between groups, with mean daily step counts in all groups remaining in the sedentary (5000 steps/day) or low activity (5000-7499 steps/day) categories for the entire study duration.","['pregnant women with obesity', 'women who are already overweight', '30 pregnant women with obesity a Fitbit Zip pedometer and randomized them into 1 of 3 groups', 'Obese Pregnant Women', 'A total of 30 participants were recruited within a 10-week period, with a dropout rate of 10% (3/30, 2 withdrawals and 1 stillbirth); 27 participants thus completed the study', 'pregnant women']","['pedometer-based intervention', 'Pedometer-Guided Physical Activity Intervention', ""control (pedometer only), app (pedometer synced to patients' personal smartphone, with self-monitoring of activity), or app-coach (addition of a health coach-delivered behavioral change program""]","['Estimated mean baseline activity levels', 'Recruitment and retention rates', 'maternal weight gain and activity levels', 'Mean BMI', 'Mean (SD) percentage of missing data days', 'activity levels', 'participant compliance with wearing pedometers (days with missing pedometer data), data syncing, and data integrity', 'Activity outcomes (step counts and active minutes']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0453984', 'cui_str': 'Zipper'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2317129', 'cui_str': 'Health coach'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439232', 'cui_str': 'min'}]",30.0,0.0752825,"Estimated mean baseline activity levels were 14.5 active min/day and 5455 steps/day, with no significant differences found in activity levels between groups, with mean daily step counts in all groups remaining in the sedentary (5000 steps/day) or low activity (5000-7499 steps/day) categories for the entire study duration.","[{'ForeName': 'Jai N', 'Initials': 'JN', 'LastName': 'Darvall', 'Affiliation': 'Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, Melbourne, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Melbourne Medical School, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Mohamed Nusry', 'Initials': 'MN', 'LastName': 'Nazeem', 'Affiliation': 'Melbourne Medical School, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Cheryce L', 'Initials': 'CL', 'LastName': 'Harrison', 'Affiliation': 'Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Clarke', 'Affiliation': 'Department of Physiotherapy, Western Health, Melbourne, Australia.'}, {'ForeName': 'Chennelle', 'Initials': 'C', 'LastName': 'Mendoza', 'Affiliation': 'Department of Physiotherapy, Western Health, Melbourne, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Parker', 'Affiliation': 'Centre for Integrated Critical Care, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Harrap', 'Affiliation': 'Melbourne Epicentre, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Teale', 'Affiliation': ""Department of Women's and Children's Services, Western Health, Melbourne, Australia.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Story', 'Affiliation': 'Centre for Integrated Critical Care, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hessian', 'Affiliation': 'Department of Anaesthesia and Pain Management, Western Health, Melbourne, Australia.'}]",JMIR mHealth and uHealth,['10.2196/15112']
29,32348796,Food-based social comparisons influence liking and consumption.,"This study examined the effects of food-based social comparisons on hedonic ratings and consumption of a meal. Participants were randomly assigned to one of three experimental conditions in which they were led to believe that they got a worse meal, a better meal, or the same meal as another participant. They then tasted and rated their own meal. Subsequent liking and ad lib food consumption were measured. Participants who were told that another person got a better meal than they did (upward comparison) liked their meal less than if they were told that another person received either the same meal as they did or a worse meal (downward comparison). Similarly, participants who were in the upward comparison condition ate less food than if they were in the control or downward comparison conditions. Consumption was mediated by liking. The results suggest that being told that someone else is eating a meal that is higher or lower in hedonic value than one's own meal induces hedonic contrast and influences liking and consumption.",2020,"Participants were randomly assigned to one of three experimental conditions in which they were led to believe that they got a worse meal, a better meal, or the same meal as another participant.",['Participants who were told that another person got a better meal than they did (upward comparison) liked their meal less than if they were told that another person'],['food-based social comparisons'],"['hedonic contrast and influences liking and consumption', 'hedonic ratings and consumption of a meal', 'Subsequent liking and ad lib food consumption']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C1282911', 'cui_str': 'Upward'}, {'cui': 'C0439092', 'cui_str': '<'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]",,0.0296622,"Participants were randomly assigned to one of three experimental conditions in which they were led to believe that they got a worse meal, a better meal, or the same meal as another participant.","[{'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Mills', 'Affiliation': 'Department of Psychology, York University, Toronto, ON, M3J 1P3, Canada. Electronic address: jsmills@yorku.ca.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Polivy', 'Affiliation': 'Department of Psychology, University of Toronto, Toronto, ON, M3J 1P3, Canada.'}, {'ForeName': 'Ayesha', 'Initials': 'A', 'LastName': 'Iqbal', 'Affiliation': 'Department of Psychology, York University, Toronto, ON, M3J 1P3, Canada.'}]",Appetite,['10.1016/j.appet.2020.104720']
30,32352803,"Condensing parent training: A randomized trial comparing the efficacy of a briefer, more intensive version of Parent-Child Interaction Therapy (I-PCIT).","OBJECTIVE


The current study examined the comparative efficacy of a more intensive version of Parent-Child Interaction Therapy (I-PCIT; 5 days/week over 2 weeks) versus a time-limited weekly PCIT format (1 day/week over 10 weeks) in treating early childhood externalizing behavior problems.
METHOD


Using a randomized trial design, 60 young children (mean age [ M age ] = 4.33 years; 65% male; 85% Latinx) with clinically elevated levels of externalizing behavior problems and their parents were assigned to either I-PCIT ( n  = 30) or time-limited PCIT ( n  = 30). Families completed pre-, post-, and follow-up assessments 6-9 months following treatment completion. Parents completed measures of child behavior, discipline practices, and parenting stress. Observational data on child behavior and parenting were also collected.
RESULTS


Noninferiority and multivariate repeated-measures analyses indicated comparable improvements across 6 out of 7 observed and parent-reported outcomes, including parenting skills, discipline practices, and child externalizing behavior problems at posttreatment. Comparable treatment gains remained at follow-up, with the caveat that parents in time-limited PCIT reported lower externalizing behavior problems compared with I-PCIT, although both groups were still significantly better compared with pretreatment. Lastly, moderation analyses indicated that parents experiencing high levels of stress benefited more from I-PCIT in terms of decreasing child externalizing behavior compared with time-limited PCIT.
CONCLUSIONS


I-PCIT appears to be a viable treatment option for families, especially those experiencing high levels of stress, in terms of targeting early externalizing behavior problems within a short period of time. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"RESULTS


Noninferiority and multivariate repeated-measures analyses indicated comparable improvements across 6 out of 7 observed and parent-reported outcomes, including parenting skills, discipline practices, and child externalizing behavior problems at posttreatment.",['60 young children (mean age [ M age ] = 4.33 years; 65% male; 85% Latinx) with clinically elevated levels of externalizing behavior problems and their parents'],"['time-limited PCIT', 'intensive version of Parent-Child Interaction Therapy (I-PCIT', 'I-PCIT']","['externalizing behavior problems', 'child behavior, discipline practices, and parenting stress', 'child externalizing behavior', 'parenting skills, discipline practices, and child externalizing behavior problems']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",60.0,0.0418372,"RESULTS


Noninferiority and multivariate repeated-measures analyses indicated comparable improvements across 6 out of 7 observed and parent-reported outcomes, including parenting skills, discipline practices, and child externalizing behavior problems at posttreatment.","[{'ForeName': 'Paulo A', 'Initials': 'PA', 'LastName': 'Graziano', 'Affiliation': 'Department of Psychology, Florida International University.'}, {'ForeName': 'Rosmary', 'Initials': 'R', 'LastName': 'Ros-Demarize', 'Affiliation': 'Department of Pediatrics, Division of Developmental-Behavioral Pediatrics, Medical University of South Carolina.'}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Hare', 'Affiliation': 'Department of Psychology, Florida International University.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000504']
31,32350413,Scheduling nab-paclitaxel combined with gemcitabine as first-line treatment for metastatic pancreatic adenocarcinoma.,"BACKGROUND


Nab-paclitaxel plus gemcitabine (nabP+gemcitabine) offers modest survival gains for patients with metastatic pancreatic ductal adenocarcinoma (PDAC). Sequential scheduling of nabP+gemcitabine in a PDAC mouse model improved efficacy; this hypothesis was tested in a clinical trial.
METHODS


Patients with previously untreated metastatic PDAC were randomised to receive nabP+gemcitabine administered either concomitantly on the same day, or sequentially, with gemcitabine administered 24 h after nabP. The primary outcome measure was progression-free survival (PFS). Secondary outcome measures were objective response rate (ORR), overall survival (OS), safety, quality of life (QoL) and predictive biomarkers.
RESULTS


In total, 71 patients received sequential (SEQ) and 75 concomitant (CON) treatment. Six-month PFS was 46% with SEQ and 32% with CON scheduling. Median PFS (5.6 versus 4.0 months, hazard ratio [HR] 0.67, 95% confidence interval [95% CI] 0.47-0.95, p = 0.022) and ORR (52% versus 31%, p = 0.023) favoured the SEQ arm; median OS was 10.2 versus 8.2 months (HR 0.93, 95% CI 0.65-1.33, p = 0.70). CTCAE Grade ≥3 neutropaenia incidence doubled with SEQ therapy but was not detrimental to QoL. Strongly positive tumour epithelial cytidine deaminase (CDA) expression favoured benefit from SEQ therapy (PFS HR 0.31, 95% CI 0.13-0.70).
CONCLUSIONS


SEQ delivery of nabP+gemcitabine improved PFS and ORR, with manageable toxicity, but did not significantly improve OS.
CLINICAL TRIAL REGISTRATION


ISRCTN71070888; ClinialTrials.gov (NCT03529175).",2020,"Median PFS (5.6 versus 4.0 months, hazard ratio [HR] 0.67, 95% confidence interval [95% CI] 0.47-0.95, p = 0.022) and ORR (52% versus 31%, p = 0.023) favoured the SEQ arm; median OS was 10.2 versus 8.2 months (HR 0.93, 95% CI 0.65-1.33,","['Patients with previously untreated metastatic PDAC', 'metastatic pancreatic adenocarcinoma', 'patients with metastatic pancreatic ductal adenocarcinoma (PDAC']","['nabP+gemcitabine', 'sequential (SEQ) and 75 concomitant (CON) treatment', 'Scheduling nab-paclitaxel combined with gemcitabine', 'paclitaxel plus gemcitabine (nabP+gemcitabine', 'gemcitabine']","['Median PFS', 'OS', 'CTCAE Grade ≥3 neutropaenia incidence', 'objective response rate (ORR), overall survival (OS), safety, quality of life (QoL) and predictive biomarkers', 'survival gains', 'ORR', 'SEQ arm; median OS', 'efficacy', 'PFS and ORR, with manageable toxicity', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0861727', 'cui_str': 'Pancreatic adenocarcinoma metastatic'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205539', 'cui_str': 'Scheduled - procedure status'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",,0.254728,"Median PFS (5.6 versus 4.0 months, hazard ratio [HR] 0.67, 95% confidence interval [95% CI] 0.47-0.95, p = 0.022) and ORR (52% versus 31%, p = 0.023) favoured the SEQ arm; median OS was 10.2 versus 8.2 months (HR 0.93, 95% CI 0.65-1.33,","[{'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Corrie', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK. pippa.corrie@addenbrookes.nhs.uk.""}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Qian', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Basu', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Valle', 'Affiliation': 'University of Manchester and The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Falk', 'Affiliation': 'Bristol Haematology and Oncology Centre, Bristol, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lwuji', 'Affiliation': 'Leicester Royal Infirmary, Leicester, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wasan', 'Affiliation': 'Hammersmith Hospital, Imperial College, London, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Palmer', 'Affiliation': 'Clatterbridge Cancer Centre, Liverpool, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Scott-Brown', 'Affiliation': 'University Hospital Coventry and Warwickshire, Coventry, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wadsley', 'Affiliation': 'Weston Park Hospital, Sheffield, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Arif', 'Affiliation': 'Velindre Cancer Centre, Cardiff, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bridgewater', 'Affiliation': 'UCL Cancer Institute, London, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Propper', 'Affiliation': 'Barts Cancer Institute, London, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gillmore', 'Affiliation': 'The Royal Free Hospital, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gopinathan', 'Affiliation': 'Cancer Research UK-Cambridge Institute, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Skells', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bundi', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Brais', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Dalchau', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Bax', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Chhabra', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Machin', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dayim', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'McAdam', 'Affiliation': 'Peterborough City Hospital, Peterborough, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cummins', 'Affiliation': 'Royal Surrey County Hospital, Guildford, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Wall', 'Affiliation': 'Western General Hospital, Edinburgh, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ellis', 'Affiliation': 'Royal Cornwall Hospitals, Truro, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Anthoney', 'Affiliation': ""St. James's University Hospitals, Leeds, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Evans', 'Affiliation': 'Beatson West of Scotland Cancer Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Y T', 'Initials': 'YT', 'LastName': 'Ma', 'Affiliation': 'Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Isherwood', 'Affiliation': 'Cancer Research UK-Cambridge Institute, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Neesse', 'Affiliation': 'Gastroenterology and Gastrointestinal Cancer Clinic, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Tuveson', 'Affiliation': 'Cold Spring Harbor Laboratory, Cold Spring Harbor, New York, USA.'}, {'ForeName': 'D I', 'Initials': 'DI', 'LastName': 'Jodrell', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}]",British journal of cancer,['10.1038/s41416-020-0846-2']
32,32349366,Site-Specific Effects of Online rTMS during a Working Memory Task in Healthy Older Adults.,"The process of manipulating information within working memory is central to many cognitive functions, but also declines rapidly in old age. Improving this process could markedly enhance the health-span in older adults. The current pre-registered, randomized and placebo-controlled study tested the potential of online repetitive transcranial magnetic stimulation (rTMS) applied at 5 Hz over the left lateral parietal cortex to enhance working memory manipulation in healthy elderly adults. rTMS was applied, while participants performed a delayed-response alphabetization task with two individually titrated levels of difficulty. Coil placement and stimulation amplitude were calculated from fMRI activation maps combined with electric field modeling on an individual-subject basis in order to standardize dosing at the targeted cortical location. Contrary to the a priori hypothesis, active rTMS significantly decreased accuracy relative to sham, and only in the hardest difficulty level. When compared to the results from our previous study, in which rTMS was applied over the left prefrontal cortex, we found equivalent effect sizes but opposite directionality suggesting a site-specific effect of rTMS. These results demonstrate engagement of cortical working memory processing using a novel TMS targeting approach, while also providing prescriptions for future studies seeking to enhance memory through rTMS.",2020,"Contrary to the a priori hypothesis, active rTMS significantly decreased accuracy relative to sham, and only in the hardest difficulty level.","['healthy elderly adults', 'Healthy Older Adults', 'older adults']","['Online rTMS', 'online repetitive transcranial magnetic stimulation (rTMS', 'rTMS', 'placebo']",['health-span'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0191049,"Contrary to the a priori hypothesis, active rTMS significantly decreased accuracy relative to sham, and only in the hardest difficulty level.","[{'ForeName': 'Lysianne', 'Initials': 'L', 'LastName': 'Beynel', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Duke University School of Medicine, 200 Trent Drive, Box 3620 DUMC, Durham, NC 27710, USA.'}, {'ForeName': 'Simon W', 'Initials': 'SW', 'LastName': 'Davis', 'Affiliation': 'Department of Neurology, Duke University School of Medicine, 3116 N Duke Street, Durham, NC 27704, USA.'}, {'ForeName': 'Courtney A', 'Initials': 'CA', 'LastName': 'Crowell', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Duke University School of Medicine, 200 Trent Drive, Box 3620 DUMC, Durham, NC 27710, USA.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Dannhauer', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Duke University School of Medicine, 200 Trent Drive, Box 3620 DUMC, Durham, NC 27710, USA.'}, {'ForeName': 'Wesley', 'Initials': 'W', 'LastName': 'Lim', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Duke University School of Medicine, 200 Trent Drive, Box 3620 DUMC, Durham, NC 27710, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Palmer', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Duke University School of Medicine, 200 Trent Drive, Box 3620 DUMC, Durham, NC 27710, USA.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Hilbig', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Duke University School of Medicine, 200 Trent Drive, Box 3620 DUMC, Durham, NC 27710, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Brito', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Duke University School of Medicine, 200 Trent Drive, Box 3620 DUMC, Durham, NC 27710, USA.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Hile', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Duke University School of Medicine, 200 Trent Drive, Box 3620 DUMC, Durham, NC 27710, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Luber', 'Affiliation': 'National Institute of Mental Health, 6001 Executive Boulevard, Bethesda, MD 20852, USA.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Lisanby', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Duke University School of Medicine, 200 Trent Drive, Box 3620 DUMC, Durham, NC 27710, USA.'}, {'ForeName': 'Angel V', 'Initials': 'AV', 'LastName': 'Peterchev', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Duke University School of Medicine, 200 Trent Drive, Box 3620 DUMC, Durham, NC 27710, USA.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Cabeza', 'Affiliation': 'Center for Cognitive Neuroscience, Duke University, 308 Research Drive, Durham, NC 27710, USA.'}, {'ForeName': 'Lawrence G', 'Initials': 'LG', 'LastName': 'Appelbaum', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Duke University School of Medicine, 200 Trent Drive, Box 3620 DUMC, Durham, NC 27710, USA.'}]",Brain sciences,['10.3390/brainsci10050255']
33,32349429,Effect of Lupin-Enriched Biscuits as Substitute Mid-Meal Snacks on Post-Prandial Interstitial Glucose Excursions in Post-Surgical Hospital Patients with Type 2 Diabetes.,"Hospital biscuit snacks offered to Type 2 Diabetes Mellitus (T2DM) patients may adversely affect glycaemic control. This study investigated the effect of lupin mid-meal biscuit snacks, compared to spelt or standard hospital biscuits, on interstitial glucose levels in post-operative T2DM inpatients. In a pilot cross-over pragmatic study, 20 patients (74 ± 12 years) consumed, in order, lupin biscuits (20% lupin), wholemeal spelt and standard plain sweet biscuits as mid-meal snacks (2 biscuits each for morning and afternoon tea) on three consecutive days. Continuous glucose monitoring, appetite perceptions and bowel motions were recorded. Glucose levels were not significantly different in the first 90 min after mid-meal biscuit consumption at morning and afternoon tea, irrespective of type. However, after consuming the lupin biscuits only, glucose levels were significantly ( p  < 0.001) reduced 90 min postprandially after dinner, indicating a potential second-meal effect. Patients also reported improved satiety after lupin biscuit consumption on day 1, compared to days 2 and 3 ( p  = 0.018). These findings suggest that lupin-enriched biscuits may improve both glycaemic control and satiety in hospitalised T2DM patients, potentially contributing to reduced length of stay. Larger controlled studies are warranted to confirm these findings and inform potential revision of hospital menu standards for T2DM patients.",2020,"Patients also reported improved satiety after lupin biscuit consumption on day 1, compared to days 2 and 3 ( p  = 0.018).","['20 patients (74 ± 12 years) consumed, in order, lupin biscuits (20% lupin), wholemeal spelt and standard plain sweet biscuits as mid-meal snacks (2 biscuits each for morning and afternoon tea) on three consecutive days', 'hospitalised T2DM patients', 'Post-Surgical Hospital Patients with Type 2 Diabetes', 'post-operative T2DM inpatients', 'T2DM patients']","['Lupin-Enriched Biscuits as Substitute Mid-Meal Snacks', 'Hospital biscuit snacks', 'lupin mid-meal biscuit snacks']","['glycaemic control and satiety', 'glucose levels', 'Continuous glucose monitoring, appetite perceptions and bowel motions', 'interstitial glucose levels', 'Glucose levels', 'satiety after lupin biscuit consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0330813', 'cui_str': 'Lupinus'}, {'cui': 'C0452501', 'cui_str': 'Cookie and/or cracker'}, {'cui': 'C0331515', 'cui_str': 'Triticum spelta'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0439550', 'cui_str': 'Afternoon'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0239966', 'cui_str': 'Hospital patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}]","[{'cui': 'C0330813', 'cui_str': 'Lupinus'}, {'cui': 'C0452501', 'cui_str': 'Cookie and/or cracker'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C1522203', 'cui_str': 'Interstitial route'}, {'cui': 'C0330813', 'cui_str': 'Lupinus'}, {'cui': 'C0452501', 'cui_str': 'Cookie and/or cracker'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",20.0,0.0156027,"Patients also reported improved satiety after lupin biscuit consumption on day 1, compared to days 2 and 3 ( p  = 0.018).","[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Skalkos', 'Affiliation': 'Department of Dietetics, Nutrition and Sport, School of Allied Health, Human Services and Sport, La Trobe University, Victoria 3086, Australia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Moschonis', 'Affiliation': 'Department of Dietetics, Nutrition and Sport, School of Allied Health, Human Services and Sport, La Trobe University, Victoria 3086, Australia.'}, {'ForeName': 'Colleen J', 'Initials': 'CJ', 'LastName': 'Thomas', 'Affiliation': 'Department of Physiology, Anatomy and Microbiology, School of Life Sciences, La Trobe University, Melbourne, Victoria 3086, Australia.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'McMillan', 'Affiliation': 'Department of Dietetics, Nutrition and Sport, School of Allied Health, Human Services and Sport, La Trobe University, Victoria 3086, Australia.'}, {'ForeName': 'Antigone', 'Initials': 'A', 'LastName': 'Kouris-Blazos', 'Affiliation': 'Department of Dietetics, Nutrition and Sport, School of Allied Health, Human Services and Sport, La Trobe University, Victoria 3086, Australia.'}]",Nutrients,['10.3390/nu12051239']
34,32349288,Investigating the Effects of Chiropractic Spinal Manipulation on EEG in Stroke Patients.,":   Objective:  The purpose of this study was to evaluate the impact of chiropractic spinal manipulation on the early somatosensory evoked potentials (SEPs) and resting-state electroencephalography (EEG) recorded from chronic stroke patients.  Methods:  Seventeen male patients (53 ± 12 years old) participated in this randomized cross-over study. The patients received chiropractic spinal manipulation and control intervention, in random order, separated by at least 24 hours. EEG was recorded before and after each intervention during rest and stimulation of the non-paretic median nerve. For resting-state EEG, the delta-alpha ratio, brain-symmetry index, and power-spectra were calculated. For SEPs, the amplitudes and latencies of N20 and N30 peaks were assessed. Source localization was performed on the power-spectra of resting-state EEG and the N30 SEP peak.  Results:  Following spinal manipulation, the N30 amplitude increased by 39%, which was a significant increase compared to the control intervention ( p  < 0.01). The latency and changes to the strength of the cortical sources underlying the N30 peak were not significant. The N20 peak, the resting-state power-spectra, delta-alpha ratio, brain-symmetry index, and resting-state source localization showed no significant changes after either intervention.  Conclusion:  A single session of chiropractic spinal manipulation increased the amplitude of the N30 SEP peak in a group of chronic stroke patients, which may reflect changes to early sensorimotor function. More research is required to investigate the long-term effects of chiropractic spinal manipulation, to better understand what impact it may have on the neurological function of stroke survivors.",2020,", the N30 amplitude increased by 39%, which was a significant increase compared to the control intervention ( p  < 0.01).","['Seventeen male patients (53 ± 12 years old', 'Stroke Patients', 'chronic stroke patients']","['spinal manipulation', 'Chiropractic Spinal Manipulation', 'chiropractic spinal manipulation', 'chiropractic spinal manipulation and control intervention']","['early somatosensory evoked potentials (SEPs) and resting-state electroencephalography (EEG', 'amplitudes and latencies of N20 and N30 peaks', 'resting-state power-spectra, delta-alpha ratio, brain-symmetry index, and resting-state source localization', 'EEG', 'amplitude of the N30 SEP peak', 'N30 amplitude', 'delta-alpha ratio, brain-symmetry index, and power-spectra']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]","[{'cui': 'C0086586', 'cui_str': 'Manipulation of spine'}, {'cui': 'C0008138', 'cui_str': 'Chiropractic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0015216', 'cui_str': 'Somatosensory evoked potential'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0037710', 'cui_str': 'Auditory localization'}]",17.0,0.0229653,", the N30 amplitude increased by 39%, which was a significant increase compared to the control intervention ( p  < 0.01).","[{'ForeName': 'Muhammad Samran', 'Initials': 'MS', 'LastName': 'Navid', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, 9000 Aalborg, Denmark.'}, {'ForeName': 'Imran Khan', 'Initials': 'IK', 'LastName': 'Niazi', 'Affiliation': 'Centre for Chiropractic Research, New Zealand College of Chiropractic, Auckland 1060, New Zealand.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Lelic', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, 9000 Aalborg, Denmark.'}, {'ForeName': 'Rasmus Bach', 'Initials': 'RB', 'LastName': 'Nedergaard', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, 9000 Aalborg, Denmark.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Holt', 'Affiliation': 'Centre for Chiropractic Research, New Zealand College of Chiropractic, Auckland 1060, New Zealand.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Amjad', 'Affiliation': 'Centre for Chiropractic Research, New Zealand College of Chiropractic, Auckland 1060, New Zealand.'}, {'ForeName': 'Asbjørn Mohr', 'Initials': 'AM', 'LastName': 'Drewes', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, 9000 Aalborg, Denmark.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Haavik', 'Affiliation': 'Centre for Chiropractic Research, New Zealand College of Chiropractic, Auckland 1060, New Zealand.'}]",Brain sciences,['10.3390/brainsci10050253']
35,32349353,Potato Protein Isolate Stimulates Muscle Protein Synthesis at Rest and with Resistance Exercise in Young Women.,"Skeletal muscle myofibrillar protein synthesis (MPS) increases in response to protein feeding and to resistance exercise (RE), where each stimuli acts synergistically when combined. The efficacy of plant proteins such as potato protein (PP) isolate to stimulate MPS is unknown. We aimed to determine the effects of PP ingestion on daily MPS with and without RE in healthy women. In a single blind, parallel-group design, 24 young women (21 ± 3 years,  n  = 12/group) consumed a weight-maintaining baseline diet containing 0.8 g/kg/d of protein before being randomized to consume either 25 g of PP twice daily (1.6 g/kg/d total protein) or a control diet (CON) (0.8 g/kg/d total protein) for 2 wks. Unilateral RE (~30% of maximal strength to failure) was performed thrice weekly with the opposite limb serving as a non-exercised control (Rest). MPS was measured by deuterated water ingestion at baseline, following supplementation (Rest), and following supplementation + RE (Exercise). Ingestion of PP stimulated MPS by 0.14 ± 0.09 %/d at Rest, and by 0.32 ± 0.14 %/d in the Exercise limb. MPS was significantly elevated by 0.20 ± 0.11 %/d in the Exercise limb in CON ( P  = 0.008). Consuming PP to increase protein intake to levels twice the recommended dietary allowance for protein augmented rates of MPS. Performance of RE stimulated MPS regardless of protein intake. PP is a high-quality, plant-based protein supplement that augments MPS at rest and following RE in healthy young women.",2020,MPS was significantly elevated by 0.20 ± 0.11 %/d in the Exercise limb in CON ( P  = 0.008).,"['healthy women', 'Young Women', '24 young women (21 ± 3 years,  n  = 12/group) consumed a', 'healthy young women']","['PP ingestion', 'Unilateral RE', 'Skeletal muscle myofibrillar protein synthesis (MPS', 'weight-maintaining baseline diet containing 0.8 g/kg/d of protein before being randomized to consume either 25 g of PP', 'control diet (CON']",['MPS'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032846', 'cui_str': 'Potato'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0597295', 'cui_str': 'Genetic translation'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C1532536', 'cui_str': 'g/kg/day'}, {'cui': 'C0456638', 'cui_str': '25G'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}]","[{'cui': 'C0597295', 'cui_str': 'Genetic translation'}]",24.0,0.0233358,MPS was significantly elevated by 0.20 ± 0.11 %/d in the Exercise limb in CON ( P  = 0.008).,"[{'ForeName': 'Sara Y', 'Initials': 'SY', 'LastName': 'Oikawa', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON L8S 4L8, Canada.'}, {'ForeName': 'Ravninder', 'Initials': 'R', 'LastName': 'Bahniwal', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON L8S 4L8, Canada.'}, {'ForeName': 'Tanya M', 'Initials': 'TM', 'LastName': 'Holloway', 'Affiliation': 'Faculty of Applied Health & Community Studies, Sheridan College, Brampton, L6Y 5H9, Canada.'}, {'ForeName': 'Changhyun', 'Initials': 'C', 'LastName': 'Lim', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON L8S 4L8, Canada.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'McLeod', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON L8S 4L8, Canada.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'McGlory', 'Affiliation': 'School of Kinesiology and Health Studies, Queens University, Kingston, K7L 3N6, Canada.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Baker', 'Affiliation': 'Department of Neurology, Michael G. DeGroote School of Medicine, McMaster University, Hamilton, L8S 4K1, Canada.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Phillips', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON L8S 4L8, Canada.'}]",Nutrients,['10.3390/nu12051235']
36,32352912,A Cluster Randomized Controlled Trial of a Lay Health Worker Intervention to Increase Healthy Eating and Physical Activity Among Vietnamese Americans.,"INTRODUCTION


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


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


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


A lay health worker intervention increased both healthy eating and physical activity knowledge and self-reported behaviors among older Vietnamese Americans.",2020,A lay health worker intervention increased both healthy eating and physical activity knowledge and self-reported behaviors among older Vietnamese Americans.,"['Vietnamese Americans', 'Each lay health worker recruited 10 participants aged 50 to 74', 'From 2008 to 2013, using flip charts, lay health workers led 2 educational sessions on HEPA (intervention) or colorectal cancer (comparison', 'older Vietnamese Americans', '64 lay health workers to 2 intervention arms']","['health worker intervention', 'Lay Health Worker Intervention', 'lay health worker intervention', 'fruits and vegetables']","['Healthy Eating and Physical Activity', 'healthy eating and physical activity knowledge and self-reported behaviors', 'HEPA knowledge and self-reported behaviors', 'physical activity weekly', 'Consumption of 5 or more daily servings of fruits and vegetables']","[{'cui': 'C4505363', 'cui_str': 'Vietnamese Americans'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0540654', 'cui_str': 'Casper Protein'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}]","[{'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}]",64.0,0.0231968,A lay health worker intervention increased both healthy eating and physical activity knowledge and self-reported behaviors among older Vietnamese Americans.,"[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Jih', 'Affiliation': 'Division of General Internal Medicine, University of California, San Francisco, 1545 Divisadero St, San Francisco, CA 94115. Email: jane.jih@ucsf.edu.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Stewart', 'Affiliation': 'Department of Public Health Sciences, University of California, Davis.'}, {'ForeName': 'Thien-Nhien', 'Initials': 'TN', 'LastName': 'Luong', 'Affiliation': 'Vietnamese Reach for Health Coalition, Fremont, California.'}, {'ForeName': 'Tung T', 'Initials': 'TT', 'LastName': 'Nguyen', 'Affiliation': 'Division of General Internal Medicine, University of California, San Francisco.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'McPhee', 'Affiliation': 'Division of General Internal Medicine, University of California, San Francisco.'}, {'ForeName': 'Bang H', 'Initials': 'BH', 'LastName': 'Nguyen', 'Affiliation': 'Research Department, Cancer Prevention Institute of California, Fremont, California.'}]",Preventing chronic disease,['10.5888/pcd17.190353']
37,32349117,One-day tropisetron treatment improves cognitive deficits and P50 inhibition deficits in schizophrenia.,"The core features of schizophrenia (SCZ) include cognitive deficits and impaired sensory gating represented by P50 inhibition deficits, which appear to be related to the α7 nicotinic acetylcholine receptor (nAChR). An agonist of nAChR receptor may improve these defects. This study aimed to investigate how administering multiple doses of tropisetron, a partial agonist of nAChR, for 1 day would affect cognitive deficits and P50 inhibition deficits in SCZ patients. We randomized 40 SCZ non-smokers into a double-blind clinical trial with four groups: placebo, 5 mg/d, 10 mg/d, and 20 mg/d of oral tropisetron. Their P50 ratios were all more than 0.5 and they took risperidone at 3-6 mg/day for at least a month before participating in the experiment. We measured the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and P50 inhibition before and one day after treatment. After one day of treatment, the total RBANS scores of the 20 mg and 5 mg tropisetron groups, and the immediate memory of the 10 mg group were significantly higher than placebo group. The P50 ratio was smaller in the 5 mg and 10 mg groups than in the placebo group (both p < 0.05) after treatment. Furthermore, the improvement in RBANS total score was correlated with increased S1 latency (p < 0.05), and the increase in immediate memory score was correlated with decreased S2 amplitude. One day of treatment with tropisetron improved both cognitive and P50 inhibition deficits, suggesting that longer term treatment with α7 nAChR agonists for these deficits in SCZ may be promising.",2020,"Furthermore, the improvement in RBANS total score was correlated with increased S1 latency (p < 0.05), and the increase in immediate memory score was correlated with decreased S2 amplitude.","['schizophrenia', 'SCZ patients']","['tropisetron', 'risperidone', 'oral tropisetron', 'placebo']","['S1 latency', 'P50 ratio', 'total RBANS scores', 'cognitive and P50 inhibition deficits', 'immediate memory score', 'P50 ratios', 'Neuropsychological Status (RBANS) and P50 inhibition', 'cognitive deficits and P50 inhibition deficits', 'RBANS total score']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0063322', 'cui_str': 'tropisetron'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0219874', 'cui_str': 'p50(csk)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2959617', 'cui_str': 'Repeatable battery for the assessment of neuropsychological status score'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C4505412', 'cui_str': 'Repeatable Battery for the Assessment of Neuropsychological Status'}, {'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}]",40.0,0.0632082,"Furthermore, the improvement in RBANS total score was correlated with increased S1 latency (p < 0.05), and the increase in immediate memory score was correlated with decreased S2 amplitude.","[{'ForeName': 'Luyao', 'Initials': 'L', 'LastName': 'Xia', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Mental Health Center, Shantou University, Shantou, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Hong', 'Affiliation': 'Mental Health Center, Shantou University, Shantou, China.'}, {'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Gaoxia', 'Initials': 'G', 'LastName': 'Wei', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Jiesi', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Huixia', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Qilong', 'Initials': 'Q', 'LastName': 'Dai', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Hanjing E', 'Initials': 'HE', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Kosten', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Xiang Yang', 'Initials': 'XY', 'LastName': 'Zhang', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China. zhangxy@psych.ac.cn.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0685-0']
38,32350749,A Phase II Randomized Trial to Explore the Potential for Pharmacokinetic Drug-Drug Interactions with Stiripentol or Valproate when Combined with Cannabidiol in Patients with Epilepsy.,"BACKGROUND


In recent randomized, placebo-controlled, phase III trials, highly purified cannabidiol demonstrated efficacy with an acceptable safety profile in patients with Lennox-Gastaut syndrome or Dravet syndrome. It is anticipated that antiepileptic drugs such as stiripentol and valproate will be administered concomitantly with cannabidiol.
OBJECTIVES


This trial evaluated the effect of cannabidiol on steady-state pharmacokinetics of stiripentol or valproate in patients with epilepsy, and the safety and tolerability of cannabidiol.
METHODS


This phase II, two-arm, parallel-group, double-blind, randomized, placebo-controlled trial recruited male and female patients with epilepsy aged 16-55 years. Patients receiving a stable dose of stiripentol or valproate were randomized 4:1 to receive concomitant double-blind cannabidiol or placebo. Patients received plant-derived, highly purified cannabidiol medicine (Epidiolex ®  in the USA; Epidyolex ®  in the EU; 100 mg/mL oral solution) at a dose of 20 mg/kg/day from day 12 to 26, following a 10-day dose-escalation period. Blood samples for pharmacokinetic evaluations were collected on days 1 and 26 before stiripentol/valproate dosing and up to 12 h postdose. Treatment-emergent adverse events (AEs) were recorded.
RESULTS


In total, 35 patients were recruited to the stiripentol arm (n = 14) or the valproate arm (n = 21). Both the safety and the pharmacokinetic populations of the stiripentol arm comprised 14 patients (2 placebo; 12 cannabidiol). The safety population of the valproate arm comprised 20 patients (4 placebo; 16 cannabidiol; one withdrew before receiving treatment); the pharmacokinetic population comprised 15 patients (3 placebo; 12 cannabidiol). Concomitant cannabidiol led to a small increase in stiripentol exposure (17% increase in maximum observed plasma concentration [C max ]; 30% increase in area under the concentration-time curve over the dosing interval [AUC tau ]). Concomitant cannabidiol also had little effect on valproate exposure (13% decrease in C max ; 17% decrease in AUC tau ) or its metabolite, 2-propyl-4-pentenoic acid (4-ene-VPA) (23% decrease in C max ; 30% decrease in AUC tau ). All changes in exposure are expressed as the dose-normalized geometric mean (CV%) day 26 to day 1 ratio. The most common AE was diarrhea; most AEs were mild. Two patients discontinued cannabidiol because of serious AEs (rash [n = 1] in the stiripentol arm; hypertransaminasemia [n = 1] in the valproate arm). A separate in vitro study investigated the bidirectional effect of cannabidiol, or its metabolite 7-carboxy-cannabidiol, on valproate plasma protein binding; no change in plasma protein binding was observed for either compound.
CONCLUSIONS


The clinical relevance of the increase in stiripentol exposure is unknown; patients receiving cannabidiol and stiripentol concomitantly should be monitored for adverse reactions as individual patient responses may vary. Coadministration of cannabidiol did not affect the pharmacokinetics of valproate or its metabolite, 4-ene-VPA, in adult patients with epilepsy. Safety results were consistent with the known safety profile of cannabidiol at a dose of 20 mg/kg/day. Clinicaltrials.gov: NCT02607891.",2020,"Coadministration of cannabidiol did not affect the pharmacokinetics of valproate or its metabolite, 4-ene-VPA, in adult patients with epilepsy.","['Patients receiving a stable dose of', 'controlled trial recruited male and female patients with epilepsy aged 16-55 years', '20 patients (4', 'patients with epilepsy', 'adult patients with epilepsy', 'In total,\xa035 patients were recruited to the stiripentol arm (n = 14) or the valproate arm (n = 21', 'Patients with Epilepsy', 'patients with Lennox-Gastaut syndrome or Dravet syndrome']","['concomitant double-blind cannabidiol or placebo', 'placebo', 'valproate', 'Stiripentol or Valproate', 'plant-derived, highly purified cannabidiol medicine (Epidiolex ®  in the USA; Epidyolex ®  in the EU; 100 mg/mL oral solution', 'stiripentol or valproate']","['stiripentol exposure', 'valproate exposure', 'AUC tau ) or its metabolite, 2-propyl-4-pentenoic acid (4-ene-VPA', 'plasma protein binding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0075262', 'cui_str': 'stiripentol'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C0238111', 'cui_str': 'Lennox-Gastaut syndrome'}, {'cui': 'C0751122', 'cui_str': 'Severe myoclonic epilepsy in infancy'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C0075262', 'cui_str': 'stiripentol'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4731581', 'cui_str': 'Epidiolex'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0991536', 'cui_str': 'Oral solution'}]","[{'cui': 'C0075262', 'cui_str': 'stiripentol'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0046536', 'cui_str': '2-propyl-4-pentenoic acid'}, {'cui': 'C0032120', 'cui_str': 'Plasma protein'}]",35.0,0.419758,"Coadministration of cannabidiol did not affect the pharmacokinetics of valproate or its metabolite, 4-ene-VPA, in adult patients with epilepsy.","[{'ForeName': 'Elinor', 'Initials': 'E', 'LastName': 'Ben-Menachem', 'Affiliation': 'Department of Clinical Neuroscience at Institute of Neuroscience and Physiology, Neurologen, University of Gothenburg, Blå Stråket 7, Plan 0, 41345, Gothenburg, Sweden. elinor.ben-menachem@neuro.gu.se.'}, {'ForeName': 'Boudewijn', 'Initials': 'B', 'LastName': 'Gunning', 'Affiliation': 'Stichting Epilepsie Instellingen Nederland, Zwolle, The Netherlands.'}, {'ForeName': 'Carmen María', 'Initials': 'CM', 'LastName': 'Arenas Cabrera', 'Affiliation': 'Hospital Universitario Virgen del Rocío, Seville, Spain.'}, {'ForeName': 'Kevan', 'Initials': 'K', 'LastName': 'VanLandingham', 'Affiliation': 'Greenwich Biosciences, Inc., Carlsbad, CA, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Crockett', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Critchley', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Wray', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}, {'ForeName': 'Bola', 'Initials': 'B', 'LastName': 'Tayo', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}, {'ForeName': 'Gilmour', 'Initials': 'G', 'LastName': 'Morrison', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Toledo', 'Affiliation': ""Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}]",CNS drugs,['10.1007/s40263-020-00726-4']
39,32353277,"Multisystemic therapy versus management as usual in the treatment of adolescent antisocial behaviour (START): 5-year follow-up of a pragmatic, randomised, controlled, superiority trial.","BACKGROUND


Multisystemic therapy is a manualised treatment programme for young people aged 11-17 years who exhibit antisocial behaviour. To our knowledge, the Systemic Therapy for At Risk Teens (START) trial is the first large-scale randomised controlled trial of multisystemic therapy in the UK. Previous findings reported to 18 months after baseline (START-I study) did not indicate superiority of multisystemic therapy compared with management as usual. Here, we report outcomes of the trial to 60 months (START-II study).
METHODS


In this pragmatic, randomised, controlled, superiority trial, young people (aged 11-17 years) with moderate-to-severe antisocial behaviour were recruited from social services, youth offending teams, schools, child and adolescent mental health services, and voluntary services across England, UK. Participants were eligible if they had at least three severity criteria indicating past difficulties across several settings and one of five general inclusion criteria for antisocial behaviour. Eligible families were randomly assigned (1:1), using stochastic minimisation and stratifying for treatment centre, sex, age at enrolment, and age at onset of antisocial behaviour, to management as usual or 3-5 months of multisystemic therapy followed by management as usual. Research assistants and investigators were masked to treatment allocation; the participants could not be masked. For this extension study, the primary outcome was the proportion of participants with offences with convictions in each group at 60 months after randomisation. This study is registered with ISRCTN, ISRCTN77132214, and is closed to accrual.
FINDINGS


Between Feb 4, 2010, and Sept 1, 2012, 1076 young people and families were assessed for eligibility and 684 were randomly assigned to management as usual (n=342) or multisystemic therapy (n=342). By 60 months' of follow-up, 188 (55%) of 342 people in the multisystemic therapy group had at least one offence with a criminal conviction, compared with 180 (53%) of 341 in the management-as-usual group (odds ratio 1·13, 95% CI 0·82-1·56; p=0·44).
INTERPRETATION


The results of the 5-year follow-up show no evidence of longer-term superiority for multisystemic therapy compared with management as usual.
FUNDING


National Institute for Health Research Health Services and Delivery Research programme.",2020,"The results of the 5-year follow-up show no evidence of longer-term superiority for multisystemic therapy compared with management as usual.
","['Participants were eligible if they had at least three severity criteria indicating past difficulties across several settings and one of five general inclusion criteria for antisocial behaviour', 'young people (aged 11-17 years) with moderate-to-severe antisocial behaviour were recruited from social services, youth offending teams, schools, child and adolescent mental health services, and voluntary services across England, UK', '1076 young people and families were assessed for eligibility and 684 were randomly assigned to management as usual (n=342) or', 'young people aged 11-17 years who exhibit antisocial behaviour', 'Eligible families']","['multisystemic therapy', 'multisystemic therapy followed by management as usual', 'Multisystemic therapy']",['proportion of participants with offences with convictions'],"[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0233523', 'cui_str': 'Antisocial behavior'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C1446401', 'cui_str': 'Voluntary services'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}]","[{'cui': 'C3840203', 'cui_str': 'Multisystemic therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",[],,0.202544,"The results of the 5-year follow-up show no evidence of longer-term superiority for multisystemic therapy compared with management as usual.
","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fonagy', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK. Electronic address: p.fonagy@ucl.ac.uk.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Butler', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cottrell', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Scott', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Pilling', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Eisler', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fuggle', 'Affiliation': 'Anna Freud National Centre for Children and Families, London, UK.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Kraam', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, UK; Rotherham Doncaster and South Humber NHS Foundation Trust, Doncaster, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Byford', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wason', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK; MRC Biostatistics Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Smith', 'Affiliation': 'Department of Psychological Sciences, Birkbeck College, University of London, London, UK.'}, {'ForeName': 'Alisa', 'Initials': 'A', 'LastName': 'Anokhina', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Ellison', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Simes', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Poushali', 'Initials': 'P', 'LastName': 'Ganguli', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Allison', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Goodyer', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}]",The lancet. Psychiatry,['10.1016/S2215-0366(20)30131-0']
40,32350816,Correction to: Is Open-Label Placebo a New Ergogenic Aid? A Commentary on Existing Studies and Guidelines for Future Research.,"Page 4, Figure 1.",2020,"Page 4, Figure 1.",[],[],[],[],[],[],,0.0186372,"Page 4, Figure 1.","[{'ForeName': 'Tiemi', 'Initials': 'T', 'LastName': 'Saito', 'Affiliation': 'Applied Physiology and Nutrition Research Group, School of Physical Education and Sport, Rheumatology Division, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Av. Dr. Arnaldo, 455, Cerqueira César, São Paulo, SP, CEP: 01246903, Brazil.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Barreto', 'Affiliation': 'Applied Physiology and Nutrition Research Group, School of Physical Education and Sport, Rheumatology Division, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Av. Dr. Arnaldo, 455, Cerqueira César, São Paulo, SP, CEP: 01246903, Brazil.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Saunders', 'Affiliation': 'Applied Physiology and Nutrition Research Group, School of Physical Education and Sport, Rheumatology Division, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Av. Dr. Arnaldo, 455, Cerqueira César, São Paulo, SP, CEP: 01246903, Brazil.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Gualano', 'Affiliation': 'Applied Physiology and Nutrition Research Group, School of Physical Education and Sport, Rheumatology Division, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Av. Dr. Arnaldo, 455, Cerqueira César, São Paulo, SP, CEP: 01246903, Brazil. gualano@usp.br.'}]","Sports medicine (Auckland, N.Z.)",['10.1007/s40279-020-01289-6']
41,32351447,Prospect of Sodium-Glucose Co-transporter 2 Inhibitors Combined With Insulin for the Treatment of Type 2 Diabetes.,"Sodium-glucose co-transporter 2 (SGLT2) inhibitors are a new family of antidiabetic drugs that reduce blood glucose independent of insulin. In this review, we present the advantages and adverse effects of SGLT2 inhibitors plus insulin therapy as a treatment regimen for patients with type 2 diabetes (T2D). Compared with placebo, SGLT2 inhibitors plus insulin therapy could significantly decrease fasting blood glucose and HbA1c, thereby reducing the daily required dose of insulin. A reduction in body weight and improvements in insulin resistance and β-cell function have also been widely reported with this therapy, and other potential advantages, including the reduction in blood pressure, adverse cardiovascular outcomes, and visceral adipose tissue volume, have been revealed. SGLT2 inhibitors cause a greater reduction than dipeptidyl peptidase-4 (DPP-4) inhibitors in body weight and the risk of cardiovascular disease. Furthermore, compared with glucagon-like peptide-1 (GLP-1) agonists, SGLT2 inhibitors reduce blood pressure, and heart failure. As this therapy is an oral preparation, an improvement in patient compliance is also achieved. Despite these advantages, however, combination therapy with SGLT2 inhibitors and insulin has several risks. Although no difference has been found in the incidence of hypoglycemic events and urinary tract infection between the administration of this combination and that of placebo, the risk of genital tract infections was reported to increase with the combination therapy. Additionally, bone adverse effects, euglycemic diabetic ketoacidosis, and volume depletion-and osmotic diuresis-related adverse effects have been observed. Altogether, we could conclude that SGLT2 inhibitors plus insulin therapy is an efficient treatment option for patients with T2D, especially those requiring high daily insulin doses and those with insulin resistance, obesity, and a high risk of cardiovascular events. However, careful monitoring of the adverse effects of this combination is also warranted.",2020,"Although no difference has been found in the incidence of hypoglycemic events and urinary tract infection between the administration of this combination and that of placebo, the risk of genital tract infections was reported to increase with the combination therapy.","['patients with T2D', 'Type 2 Diabetes', 'patients with type 2 diabetes (T2D']","['Sodium-glucose co-transporter 2 (SGLT2) inhibitors', 'placebo', 'inhibitors plus insulin therapy', 'SGLT2 inhibitors plus insulin therapy', 'SGLT2', 'Sodium-Glucose Co-transporter 2 Inhibitors Combined With Insulin', 'placebo, SGLT2 inhibitors plus insulin therapy', 'glucagon-like peptide-1 (GLP-1) agonists, SGLT2 inhibitors']","['risk of genital tract infections', 'fasting blood glucose and HbA1c, thereby reducing the daily required dose of insulin', 'blood pressure, and heart failure', 'hypoglycemic events and urinary tract infection', 'body weight', 'blood pressure, adverse cardiovascular outcomes, and visceral adipose tissue volume', 'bone adverse effects, euglycemic diabetic ketoacidosis, and volume depletion-and osmotic diuresis-related adverse effects', 'insulin resistance and β-cell function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C2314882', 'cui_str': 'Genital Tract Infections'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C4524093', 'cui_str': 'Euglycaemic diabetic ketoacidosis'}, {'cui': 'C0546884', 'cui_str': 'Hypovolemia'}, {'cui': 'C0232823', 'cui_str': 'Osmotic diuresis'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}]",,0.0347668,"Although no difference has been found in the incidence of hypoglycemic events and urinary tract infection between the administration of this combination and that of placebo, the risk of genital tract infections was reported to increase with the combination therapy.","[{'ForeName': 'Yinqiu', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Endocrinology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Chenhe', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'Department of Endocrinology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yangli', 'Initials': 'Y', 'LastName': 'Ye', 'Affiliation': 'Department of Endocrinology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Mingxiang', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Department of Endocrinology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Qu', 'Affiliation': 'Department of Bone and Joint Surgery, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}]",Frontiers in endocrinology,['10.3389/fendo.2020.00190']
42,32353206,Effects of individual pelvic floor muscle training vs individual training progressing to group training vs group training alone in women with stress urinary incontinence: A randomized clinical trial.,"AIMS


To assess the effects of individual pelvic floor muscle (PFM) training vs individual training (IT) progressing to group training (GT) vs group-only training in women with stress urinary incontinence (SUI).
METHODS


Randomized controlled and pragmatic clinical trials with 90 women with SUI. Participants were randomly allocated to one of three groups: IT, GT, or four individual sessions progressing to group training (IPGT). The intervention included 12 sessions, once a week, with direct supervision by a physical therapist.
PRIMARY OUTCOME


severity according to the King's Health Questionnaire.
SECONDARY OUTCOMES


PFM function by palpation and manometer, bladder and exercise diaries, PFM training adherence, and self-efficacy. Reassessments were conducted at the end of the intervention, 3 and 6 months after the intervention. Intra- and intergroup analysis for all outcomes was performed using a multivariate analysis of variance. In the mixed-effects model used, the evaluation groups and times and their interactions were considered. A significance level of 5% was adopted.
RESULTS


After the intervention, the severity measure improved in all three groups (P < .001), without difference between them (P = .56). The benefits of the intervention were maintained 3 and 6 months after the end of the supervised training (P < .001). The IPGT group had a significant improvement in PFM function when compared to the other groups posttreatment (P < .001).
CONCLUSION


PFM training improved the severity of urinary incontinence in all groups after 12 sessions of training supervised by a physical therapist. IT progressing to GT improved the function of upper PFM when compared to the other groups.",2020,"After the intervention, the severity measure improved in all three groups (P < .001), without difference between them (P = .56).","['women with stress urinary incontinence (SUI', 'women with stress urinary incontinence', '90 women with SUI']","['IT, GT, or four individual sessions progressing to group training (IPGT', 'individual pelvic floor muscle training vs individual training progressing to group training vs group training alone', 'individual pelvic floor muscle (PFM) training vs individual training (IT) progressing to group training (GT) vs group-only training', 'PFM training', 'direct supervision by a physical therapist']","['PFM function by palpation and manometer, bladder and exercise diaries, PFM training adherence, and self-efficacy', 'severity of urinary incontinence', 'PFM function', 'severity measure', 'function of upper PFM', ""severity according to the King's Health Questionnaire""]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C2720530', 'cui_str': 'Manometer'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",90.0,0.0228563,"After the intervention, the severity measure improved in all three groups (P < .001), without difference between them (P = .56).","[{'ForeName': 'Vilena B', 'Initials': 'VB', 'LastName': 'Figueiredo', 'Affiliation': 'Physical Therapy\xa0Department, Federal University of São Carlos (UFSCar), São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Simony L', 'Initials': 'SL', 'LastName': 'Nascimento', 'Affiliation': ''}, {'ForeName': 'Renata F L', 'Initials': 'RFL', 'LastName': 'Martínez', 'Affiliation': 'Physical Therapy\xa0Department, Federal University of São Carlos (UFSCar), São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Clara T S', 'Initials': 'CTS', 'LastName': 'Lima', 'Affiliation': 'Physical Therapy\xa0Department, Federal University of Ceará (UFC), Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Cristine H J', 'Initials': 'CHJ', 'LastName': 'Ferreira', 'Affiliation': 'Department of Health Sciences, Health Science Department, University of São Paulo (USP), Ribeirão Preto-SP, São Paulo, Brazil.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Driusso', 'Affiliation': 'Physical Therapy\xa0Department, Federal University of São Carlos (UFSCar), São Carlos, São Paulo, Brazil.'}]",Neurourology and urodynamics,['10.1002/nau.24370']
43,32353218,"Effect of a combined exercise program on physical fitness, lung function, and quality of life in patients with controlled asthma and exercise symptoms: A randomized controlled trial.","BACKGROUND


Asthmatic patients may benefit from exercise training, although the effects of a combined aerobic and resistance training program are still poorly investigated in children and adolescents.
OBJECTIVE


To analyze the effects of a combined exercise training (resistance and aerobic) program on aerobic fitness, lung function, asthma control and quality of life in a group of mild-moderate asthmatic children with exercise symptoms.
METHODS


This was a 12-week randomized controlled trial including children and adolescents diagnosed with mild-moderate asthma and presenting exercise-induced symptoms. The intervention group (IG) performed the exercise training (resistance and aerobic) 3 days/week, for 60 minutes. The control group (CG) followed routine clinical orientations. The main outcomes were cardiorespiratory fitness, muscle strength, lung function, quality of life, asthma control, and functional tests after 3 months of the intervention.
RESULTS


Fifty-three patients (IG = 25 and CG = 28) with a mean age of 11.5 ± 2.6 years were included. No significant differences were found between groups regarding lung function, asthma control, quality of life, and functional tests. Ventilatory equivalent for oxygen consumption at ventilatory threshold (P = .025;  η   p   2     = 0.083), peak oxygen consumption (P = .008;  η   p   2     = 0.116) and test duration (P = .014;  η   p   2     = 0.1) presented greater improvements in the IG. In addition, improvements were observed in leg press (P < .001;  η   p   2     = 0.36), hamstring curl (P = .001;  η   p   2     = 0.217), high row (P = .003;  η   p   2     = .167), low row (P = .009;  η   p   2     = 0.128) and quadriceps leg extension (P = .015;  η   p   2     = 0.108) in the IG.
CONCLUSION


Combined exercise training (resistance and aerobic) improved cardiorespiratory fitness and muscle strength in children and adolescents with controlled asthma and exercise symptoms.",2020,"In addition, improvements were observed in leg press (P < .001;  η   p   2     = 0.36), hamstring curl (P = .001;  η   p   2     = 0.217), high row (P = .003;  η   p   2     = .167), low row (P = .009;  ","['children and adolescents diagnosed with mild-moderate asthma and presenting exercise-induced symptoms', 'Fifty-three patients (IG\u2009=\u200925 and CG\u2009=\u200928) with a mean age of 11.5\u2009±\u20092.6 years were included', 'patients with controlled asthma and exercise symptoms', 'mild-moderate asthmatic children with exercise symptoms', 'Asthmatic patients', 'children and adolescents with controlled asthma and exercise symptoms', 'children and adolescents']","['exercise training', 'combined aerobic and resistance training program', 'exercise training (resistance and aerobic', 'combined exercise training (resistance and aerobic) program', 'Combined exercise training (resistance and aerobic', 'combined exercise program']","['leg press', 'quadriceps leg extension', 'cardiorespiratory fitness, muscle strength, lung function, quality of life, asthma control, and functional tests', 'hamstring curl', 'lung function, asthma control, quality of life, and functional tests', 'peak oxygen consumption', 'physical fitness, lung function, and quality of life', 'aerobic fitness, lung function, asthma control and quality of life', 'cardiorespiratory fitness and muscle strength']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0010474', 'cui_str': ""Curling's ulcers""}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}]",,0.0378759,"In addition, improvements were observed in leg press (P < .001;  η   p   2     = 0.36), hamstring curl (P = .001;  η   p   2     = 0.217), high row (P = .003;  η   p   2     = .167), low row (P = .009;  ","[{'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Sanz-Santiago', 'Affiliation': 'Pulmonology Unit, Hospital Universitario Infantil Niño Jesús de Madrid, Madrid, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Diez-Vega', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Santana-Sosa', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Lopez Nuevo', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Iturriaga Ramirez', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Fernanda Maria', 'Initials': 'FM', 'LastName': 'Vendrusculo', 'Affiliation': 'Laboratory of Pediatric Physical Activity, Infant Center, PUCRS, Porto Alegre, Brazil.'}, {'ForeName': 'Márcio Vinícius Fagundes', 'Initials': 'MVF', 'LastName': 'Donadio', 'Affiliation': 'Laboratory of Pediatric Physical Activity, Infant Center, PUCRS, Porto Alegre, Brazil.'}, {'ForeName': 'José Ramón', 'Initials': 'JR', 'LastName': 'Villa Asensi', 'Affiliation': 'Pulmonology Unit, Hospital Universitario Infantil Niño Jesús de Madrid, Madrid, Spain.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Pérez-Ruiz', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, Spain.'}]",Pediatric pulmonology,['10.1002/ppul.24798']
44,32353962,Circulating Ionized Magnesium as a Measure of Supplement Bioavailability: Results from a Pilot Study for Randomized Clinical Trial.,"Oral supplementation may improve the dietary intake of magnesium, which has been identified as a shortfall nutrient. We conducted a pilot study to evaluate appropriate methods for assessing responses to the ingestion of oral magnesium supplements, including ionized magnesium in whole blood (iMg 2+ ) concentration, serum total magnesium concentration, and total urinary magnesium content. In a single-blinded crossover study, 17 healthy adults were randomly assigned to consume 300 mg of magnesium from MgCl 2  (ReMag ® , a picosized magnesium formulation) or placebo, while having a low-magnesium breakfast. Blood and urine samples were obtained for the measurement of iMg 2+ , serum total magnesium, and total urine magnesium, during 24 h following the magnesium supplement or placebo dosing. Bioavailability was assessed using area-under-the-curve (AUC) as well as maximum (C max ) and time-to-maximum (T max ) concentration. Depending on normality, data were expressed as the mean ± standard deviation or median (range), and differences between responses to MgCl 2  or placebo were measured using the paired  t -test or Wilcoxon signed-rank test. Following MgCl 2  administration versus placebo administration, we observed significantly greater increases in iMg 2+  concentrations (AUC = 1.51 ± 0.96 vs. 0.84 ± 0.82 mg/dL·24h; C max  = 1.38 ± 0.13 vs. 1.32 ± 0.07 mg/dL, respectively; both  p  < 0.05) but not in serum total magnesium (AUC = 27.00 [0, 172.93] vs. 14.55 [0, 91.18] mg/dL·24h; C max  = 2.38 [1.97, 4.01] vs. 2.24 [1.98, 4.31] mg/dL) or in urinary magnesium (AUC = 201.74 ± 161.63 vs. 139.30 ± 92.84 mg·24h; C max  = 26.12 [12.91, 88.63] vs. 24.38 [13.51, 81.51] mg/dL;  p  > 0.05). Whole blood iMg 2+  may be a more sensitive measure of acute oral intake of magnesium compared to serum and urinary magnesium and may be preferred for assessing supplement bioavailability.",2020,(AUC = 201.74 ± 161.63 vs. 139.30 ± 92.84 mg·24h; C max  = 26.12,['17 healthy adults'],"['urinary magnesium', 'consume 300 mg of magnesium from MgCl 2  (ReMag ® , a picosized magnesium formulation) or placebo, while having a low-magnesium breakfast', 'placebo']","['Blood and urine samples', 'ionized magnesium in whole blood (iMg 2+ ) concentration, serum total magnesium concentration, and total urinary magnesium content', 'Bioavailability', 'serum total magnesium, and total urine magnesium', 'iMg 2+  concentrations', 'maximum (C max ) and time-to-maximum (T max ) concentration', 'serum total magnesium', 'Supplement Bioavailability']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0240291', 'cui_str': 'Mg reduced'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0428308', 'cui_str': 'Magnesium measurement, urine'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]",17.0,0.300493,(AUC = 201.74 ± 161.63 vs. 139.30 ± 92.84 mg·24h; C max  = 26.12,"[{'ForeName': 'Jiada', 'Initials': 'J', 'LastName': 'Zhan', 'Affiliation': 'Public Health Nutrition, Case Western Reserve University, 10900 Euclid Avenue, Cleveland, OH 44106,USA.'}, {'ForeName': 'Taylor C', 'Initials': 'TC', 'LastName': 'Wallace', 'Affiliation': 'Department of Nutrition and Food Studies, George Mason University, MS1F7, 4400 University Drive,Fairfax, VA 22030, USA.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Butts', 'Affiliation': 'Department of Nutrition Science, Purdue University, 700 West State Street, West Lafayette, IN 47907, USA.'}, {'ForeName': 'Sisi', 'Initials': 'S', 'LastName': 'Cao', 'Affiliation': 'Department of Nutrition Science, Purdue University, 700 West State Street, West Lafayette, IN 47907, USA.'}, {'ForeName': 'Velarie', 'Initials': 'V', 'LastName': 'Ansu', 'Affiliation': 'Department of Applied Health Science, School of Public Health, Indiana University Bloomington, Bloomington, IN 47405, USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Spence', 'Affiliation': 'Department of Applied Health Science, School of Public Health, Indiana University Bloomington, Bloomington, IN 47405, USA.'}, {'ForeName': 'Connie M', 'Initials': 'CM', 'LastName': 'Weaver', 'Affiliation': 'Weaver and Associates Consulting, LLC, West Lafayette, IN 47906, USA.'}, {'ForeName': 'Nana', 'Initials': 'N', 'LastName': 'Gletsu-Miller', 'Affiliation': 'Department of Applied Health Science, School of Public Health, Indiana University Bloomington, Bloomington, IN 47405, USA.'}]",Nutrients,['10.3390/nu12051245']
45,32353974,"Suppression of Oral Sweet Sensations during Consumption of Sweet Food in Humans: Effects on Gastric Emptying Rate, Glycemic Response, Appetite, Food Satisfaction and Desire for Basic Tastes.","Suppression of oral sweet sensation (OSS) acutely reduces intake of sweet-tasting food due to lower liking. However, little is known about other physiological responses during both the prandial and postprandial phase. Here, we explored the effects of  Gymnema sylvestre  (GS)-based suppression of OSS of several types of sweet-tasting food (muffin, sweet yogurt, banana) on gastric emptying, blood glucose (BG), plasma insulin (PI), appetite indices (hunger, fullness and prospective consumption), satisfaction and desire for tastes. Fifteen healthy subjects (22 ± 3 years, 9 women) took part in the study. Subjects rinsed their mouth with either GS solution or distilled water before eating the sweet-tasting food. Subjects felt decreased sweet taste intensity and reduced taste liking associated with GS rinsing after consuming each food, compared with rinsing with distilled water ( p  < 0.05). Gastric emptying, BG, PI and appetite indices during and after the prandial phase did not significantly change with GS rinsing compared to rinsing with distilled water ( p  > 0.05). Higher desire for sweet taste as well as lower satisfaction ( p  < 0.05) in the postprandial phase were observed with GS rinsing. These results suggest that the suppression of OSS does not affect gastric emptying, glycemic response and appetite during and after consumption of sweet-tasting food.",2020,Higher desire for sweet taste as well as lower satisfaction ( p  < 0.05) in the postprandial phase were observed with GS rinsing.,"['Oral Sweet Sensations during Consumption of Sweet Food in Humans', 'Fifteen healthy subjects (22 ± 3 years, 9 women) took part in the study']","['oral sweet sensation (OSS', 'GS solution or distilled water before eating the sweet-tasting food', 'GS rinsing']","['Gastric Emptying Rate, Glycemic Response, Appetite, Food Satisfaction and Desire for Basic Tastes', 'gastric emptying, blood glucose (BG), plasma insulin (PI), appetite indices (hunger, fullness and prospective consumption), satisfaction and desire for tastes', 'Gastric emptying, BG, PI and appetite indices', 'gastric emptying, glycemic response and appetite', 'sweet taste intensity and reduced taste liking']","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0453865', 'cui_str': 'Sweet food'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C1701810', 'cui_str': 'Rinse'}]","[{'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0858600', 'cui_str': 'Taste sweet'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",15.0,0.0208928,Higher desire for sweet taste as well as lower satisfaction ( p  < 0.05) in the postprandial phase were observed with GS rinsing.,"[{'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Kashima', 'Affiliation': 'Faculty of Health Sciences, Hiroshima Shudo University, 1-1-1 Ozuka-higashi, Asaminami-ku, Hiroshima 731-3195, Japan.'}, {'ForeName': 'Kanako', 'Initials': 'K', 'LastName': 'Kimura', 'Affiliation': 'School of Health Sciences, Prefectural University of Hiroshima, 1-1-71 Ujina-higashi, Minami-ku, Hiroshima 734-8558, Japan.'}, {'ForeName': 'Natsumi', 'Initials': 'N', 'LastName': 'Nishitani', 'Affiliation': 'School of Health Sciences, Prefectural University of Hiroshima, 1-1-71 Ujina-higashi, Minami-ku, Hiroshima 734-8558, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Yamaoka Endo', 'Affiliation': 'School of Health Sciences, Prefectural University of Hiroshima, 1-1-71 Ujina-higashi, Minami-ku, Hiroshima 734-8558, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Fukuba', 'Affiliation': 'School of Health Sciences, Prefectural University of Hiroshima, 1-1-71 Ujina-higashi, Minami-ku, Hiroshima 734-8558, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Kashima', 'Affiliation': 'School of Health Sciences, Prefectural University of Hiroshima, 1-1-71 Ujina-higashi, Minami-ku, Hiroshima 734-8558, Japan.'}]",Nutrients,['10.3390/nu12051249']
46,32289380,Clinical outcomes in men of diverse ethnic backgrounds with metastatic castration-resistant prostate cancer.,"BACKGROUND


We have shown previously in multivariable analysis that black men had 19% lower risk of death than white men with metastatic castration-resistant prostate cancer (mCRPC) treated with a docetaxel and prednisone (DP)-based regimen. The primary goal of this analysis was to compare progression-free survival (PFS), biochemical PFS, ≥50% decline in prostate-specific antigen (PSA) from baseline and objective response rate (ORR) in white, black and Asian men with mCRPC treated with a DP-based regimen.
PATIENTS AND METHODS


Individual patient data from 8820 mCRPC men randomized on nine phase III trials to a DP-containing regimen were combined. Race used in the analysis was based on self-report. End points were PFS, biochemical PSA, ≥50% decline in PSA from baseline and ORR. The proportional hazards and the logistic regression models were employed to assess the prognostic importance of race in predicting outcomes adjusting for established prognostic factors.
RESULTS


Of 8820 patients, 7528 (85%) were white, 500 (6%) were black, 424 were Asian (5%) and 368 (4%) had race unspecified. Median PFS were 8.3 [95% confidence interval (CI) 8.2-8.5], 8.2 (95% CI 7.4-8.8) and 8.3 (95% CI 7.6-8.8) months in white, black and Asian men, respectively. Median PSA PFS were 9.9 (95% CI 9.7-10.4), 8.5 (95% CI 8.0-10.3) and 11.1 (95% CI 9.9-12.5) months in white, black and Asian men, respectively.
CONCLUSIONS


We observed no differences in clinical outcomes by race and ethnic groups in men with mCRPC enrolled on these phase III clinical trials with DP.",2020,"Median PSA PFS were 9.7 months (95% CI 9.4-10), 8.5 months (95% CI 7.6-10) and 10.0 (95% CI 9.5-11.8) in white, black and Asian men, respectively.
","['white, black and Asian men with mCRPC treated with a DP-based regimen', 'men with mCRPC enrolled on these phase III clinical trials with DP', 'black men had 19% lower risk of death than white men with metastatic castration resistant prostate cancer (mCRPC) treated with a', 'Men of Diverse Ethnic s with Metastatic Castration Resistant Prostate Cancer', 'Of 8,820 patients, 7,528 (85%) were white, 500 (6%) were black, 424 were Asian (5%) and 368 (4%) had race unspecified', 'Individual patient data from 8,820 mCRPC men randomized on nine phase III trials to DP-containing regimen were combined']",['docetaxel (D) and prednisone (P)-based regimen'],"['Median PSA PFS', 'Median PFS', 'progression-free survival (PFS), biochemical PFS, ≥50% decline in PSA from baseline and objective response rate (ORR']","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",8820.0,0.269513,"Median PSA PFS were 9.7 months (95% CI 9.4-10), 8.5 months (95% CI 7.6-10) and 10.0 (95% CI 9.5-11.8) in white, black and Asian men, respectively.
","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Halabi', 'Affiliation': 'Duke University Medical Center and Duke University, Durham, USA. Electronic address: susan.halabi@duke.edu.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Old Dominion University, Norfolk, USA.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Tangen', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rosenthal', 'Affiliation': 'The Royal Melbourne Hospital, Parkville, Australia.'}, {'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Petrylak', 'Affiliation': 'Yale School of Medicine, New Haven, USA.'}, {'ForeName': 'I M', 'Initials': 'IM', 'LastName': 'Thompson', 'Affiliation': 'Christus San Rosa Hospital Medical Center, San Antonio, USA.'}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': 'British Columbia Cancer Agency - Vancouver Centre, Vancouver, Canada.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'De Bono', 'Affiliation': 'The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, Sutton, UK.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Araujo', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Logothetis', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Eisenberger', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, USA.'}, {'ForeName': 'D I', 'Initials': 'DI', 'LastName': 'Quinn', 'Affiliation': 'University of Southern California Norris Comprehensive Cancer Center, Los Angeles, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, USA.'}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Higano', 'Affiliation': 'University of Washington and Fred Hutchinson Cancer Research Center, Seattle, USA.'}, {'ForeName': 'I F', 'Initials': 'IF', 'LastName': 'Tannock', 'Affiliation': 'Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada.'}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Small', 'Affiliation': 'University of California, San Francisco, San Francisco, USA.'}, {'ForeName': 'W K', 'Initials': 'WK', 'LastName': 'Kelly', 'Affiliation': 'Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.03.309']
47,32353544,Medication treatment for opioid use disorder in expectant mothers (MOMs): Design considerations for a pragmatic randomized trial comparing extended-release and daily buprenorphine formulations.,"Opioid use disorder (OUD) in pregnant women has increased significantly in recent years. Maintaining these women on sublingual (SL) buprenorphine (BUP) is an evidence-based practice but BUP-SL is associated with several disadvantages that an extended-release (XR) BUP formulation could eliminate. The National Drug Abuse Treatment Clinical Trials Network (CTN) is conducting an intent-to-treat, two-arm, open-label, pragmatic randomized controlled trial, Medication treatment for Opioid-dependent expectant Mothers (MOMs), to compare mother and infant outcomes of pregnant women with OUD treated with BUP-XR, relative to BUP-SL. A second aim is to determine the relative economic value of utilizing BUP-XR. Approximately 300 pregnant women with an estimated gestational age (EGA) of 6-30 weeks, recruited from 12 sites, will be randomized in a 1:1 ratio to BUP-XR or BUP-SL, balancing on site, EGA, and BUP-SL status (taking/not taking) at the time of randomization. Participants will be provided with study medication and attend weekly medication visits through 12 months postpartum. Participants will be invited to participate in two sub-studies to evaluate the: 1) mechanisms by which BUP-XR may improve mother and infant outcomes; and 2) effects of prenatal exposure to BUP-XR versus BUP-SL on infant neurodevelopment. This paper describes the key design decisions for the main trial made during protocol development. This Investigational New Drug (IND) trial uniquely uses pragmatic features where feasible in order to maximize external validity, hence increasing the potential to inform clinical practice guidelines and address multiple knowledge gaps for treatment of this patient population.",2020,"Approximately 300 pregnant women with an estimated gestational age (EGA) of 6-30 weeks, recruited from 12 sites, will be randomized in a 1:1 ratio to BUP-XR or BUP-SL, balancing on site, EGA, and BUP-SL status (taking/not taking) at the time of randomization.","['expectant mothers (MOMs', 'Approximately 300 pregnant women with an estimated gestational age (EGA) of 6-30\u202fweeks, recruited from 12 sites', 'pregnant women with OUD treated with BUP-XR, relative to BUP-SL', 'pregnant women']","['sublingual (SL) buprenorphine (BUP', 'buprenorphine formulations', 'prenatal exposure to BUP-XR versus BUP-SL']",[],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1442163', 'cui_str': 'MoM'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}]","[{'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]",[],300.0,0.0591114,"Approximately 300 pregnant women with an estimated gestational age (EGA) of 6-30 weeks, recruited from 12 sites, will be randomized in a 1:1 ratio to BUP-XR or BUP-SL, balancing on site, EGA, and BUP-SL status (taking/not taking) at the time of randomization.","[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA. Electronic address: winhusen@carc.uc.edu.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Lofwall', 'Affiliation': 'Departments of Behavioral Science and Psychiatry, University of Kentucky College of Medicine, Center on Drug and Alcohol Research, 845 Angliana Avenue, Lexington, KY 40508, USA.'}, {'ForeName': 'Hendrée E', 'Initials': 'HE', 'LastName': 'Jones', 'Affiliation': 'UNC Horizons and Department of Obstetrics and Gynecology, University of North Carolina Chapel Hill, 410 North Greensboro St., Carrboro, NC 27510, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wilder', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lindblad', 'Affiliation': 'The Emmes Company, LLC, 401 N Washington Street, Suite 700, Rockville, MD 20850, USA.'}, {'ForeName': 'Davida M', 'Initials': 'DM', 'LastName': 'Schiff', 'Affiliation': 'Division of General Academic Pediatrics, MassGeneral Hospital for Children, 125 Nashua St Suite 860, Boston, MA 02114, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Wexelblatt', 'Affiliation': ""Perinatal Institute, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH 45229, USA; Department of Pediatrics, University of Cincinnati College of Medicine, 3230 Eden Avenue, Cincinnati, OH 45229, USA.""}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Merhar', 'Affiliation': ""Perinatal Institute, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH 45229, USA; Department of Pediatrics, University of Cincinnati College of Medicine, 3230 Eden Avenue, Cincinnati, OH 45229, USA.""}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Murphy', 'Affiliation': 'Department of Healthcare Policy & Research, Weill Cornell Medical College, 425 East 61st Street Suite 301, New York, NY 10065, USA.'}, {'ForeName': 'Shelly F', 'Initials': 'SF', 'LastName': 'Greenfield', 'Affiliation': ""Department of Psychiatry, Harvard Medical School, 25 Shattuck Street, Boston, MA 02115, USA; Division of Alcohol, Drug and Addictions and the Division of Women's Mental Health, McLean Hospital, 115 Mill Street, Belmont, MA 02478, USA.""}, {'ForeName': 'Mishka', 'Initials': 'M', 'LastName': 'Terplan', 'Affiliation': 'Friends Research Institute,1040 Park Ave Suite 103, Baltimore, MD 21201, USA.'}, {'ForeName': 'Elisha M', 'Initials': 'EM', 'LastName': 'Wachman', 'Affiliation': 'Department of Pediatrics, Boston Medical Center, 801 Albany Street, Boston, MA 02119, USA.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Kropp', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Theobald', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Lewis', 'Affiliation': 'The Emmes Company, LLC, 401 N Washington Street, Suite 700, Rockville, MD 20850, USA.'}, {'ForeName': 'Abigail G', 'Initials': 'AG', 'LastName': 'Matthews', 'Affiliation': 'The Emmes Company, LLC, 401 N Washington Street, Suite 700, Rockville, MD 20850, USA.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Guille', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Medical University of South Carolina, 67 President St., MSC 861, Charleston, SC 29425, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Silverstein', 'Affiliation': 'Department of Pediatrics, Boston Medical Center, Boston University School of Medicine, 88 East Newton Street, Boston, MA 02118, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Rosa', 'Affiliation': 'Center for the Clinical Trials Network, National Institute on Drug Abuse, 6001 Executive Blvd, Bethesda, MD 20892, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106014']
48,32353739,Real time SVD-based clutter filtering using randomized singular value decomposition and spatial downsampling for micro-vessel imaging on a Verasonics ultrasound system.,"Singular value decomposition (SVD)-based clutter filters can robustly reject the tissue clutter as compared with the conventional high pass filter-based clutter filters. However, the computational burden of SVD makes real time SVD-based clutter filtering challenging (e.g. frame rate at least 10-15 Hz with region of interest of about 4 × 4 cm 2 ). Recently, we proposed an acceleration method based on randomized SVD (rSVD) clutter filtering and randomized spatial downsampling, which can significantly reduce the computational complexity without compromising the clutter rejection capability. However, this method has not been implemented on an ultrasound scanner and tested for its performance. In this study, we implement this acceleration method on a Verasonics scanner using a multi-core CPU architecture, and evaluate the selections of the imaging and processing parameters to enable real time micro-vessel imaging. The Blood-to-Clutter Ratio (BCR) performance was evaluated on a Verasonics machine with different settings of parameters such as block size and ensemble size. The demonstration of real time process was implemented on a 12-core CPU (downsampling factor of 12, 12-threads in this study) host computer. The processing time of the rSVD-based clutter filter was less than 30 ms and BCRs were higher than 20 dB as the block size, ensemble size and the rank of tissue clutter subspace were set as 30 × 30, 45 and 26 respectively. We also demonstrate that the micro-vessel imaging frame rate of the proposed architecture can reach approximately 22 Hz when the block size, ensemble size and the rank of tissue clutter subspace were set as 20 × 20 pixels, 45 and 26 respectively (using both images and supplementary videos). The proposed method may be important for real time 2D scanning of tumor microvessels in 3D to select and store the most representative 2D view with most abnormal micro-vessels for better diagnosis.",2020,"The processing time of the rSVD-based clutter filter was less than 30 ms and BCRs were higher than 20 dB as the block size, ensemble size and the rank of tissue clutter subspace were set as 30 × 30, 45 and 26 respectively.",[],[],"['Blood-to-Clutter Ratio (BCR) performance', 'processing time of the rSVD-based clutter filter']",[],[],"[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0009090', 'cui_str': 'Cluttering'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0039010', 'cui_str': 'Swine Vesicular Disease'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0180860', 'cui_str': 'Filter'}]",,0.0321407,"The processing time of the rSVD-based clutter filter was less than 30 ms and BCRs were higher than 20 dB as the block size, ensemble size and the rank of tissue clutter subspace were set as 30 × 30, 45 and 26 respectively.","[{'ForeName': 'U-Wai', 'Initials': 'UW', 'LastName': 'Lok', 'Affiliation': 'Department of Radiology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Song', 'Affiliation': 'Department of Radiology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Trzasko', 'Affiliation': 'Department of Radiology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Daigle', 'Affiliation': 'Verasonics Inc., Kirkland, WA, USA.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Borisch', 'Affiliation': 'Department of Radiology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.'}, {'ForeName': 'Chengwu', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Department of Radiology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Gong', 'Affiliation': 'Department of Radiology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': 'Department of Radiology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.'}, {'ForeName': 'Wenwu', 'Initials': 'W', 'LastName': 'Ling', 'Affiliation': 'Department of Ultrasound, West China Hospital of Sichuan University, China.'}, {'ForeName': 'Shigao', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA. Electronic address: Chen.Shigao@mayo.edu.'}]",Ultrasonics,['10.1016/j.ultras.2020.106163']
49,32289134,PURL: Can drinking more water prevent urinary tract infections?,A high-quality randomized controlled trial says 'Yes.',2020,A high-quality randomized controlled trial says 'Yes.',[],[],[],[],[],[],,0.07454,A high-quality randomized controlled trial says 'Yes.',"[{'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'McCollum', 'Affiliation': 'Family Medicine Residency, Dwight David Eisenhower Army Medical Center, Fort Gordon, GA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Garigan', 'Affiliation': 'Family Medicine Residency, Dwight David Eisenhower Army Medical Center, Fort Gordon, GA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Earwood', 'Affiliation': 'Family Medicine Residency, Dwight David Eisenhower Army Medical Center, Fort Gordon, GA, USA.'}]",The Journal of family practice,[]
50,32354661,How continuum beliefs can reduce stigma of schizophrenia: The role of perceived similarities.,"Growing evidence has shown continuum beliefs as a promising tool to reduce psychiatric stigma in the general population, but data still lack regarding mechanisms underlying this effect. This study aims at testing the hypothesis that continuum beliefs affect public stigma and self-stigma by increasing perceived similarities between oneself and people with schizophrenia. Perceiving such similarities may reduce public stigma and increase self-stigma in the general population. The current study was preregistered on OSF. Data were collected via an on-line survey (N = 565). Participants were randomly assigned to one of the three experimental conditions. Continuum beliefs were induced with short videos supporting either a continuum viewpoint of schizophrenia, a categorial viewpoint of schizophrenia, or a neutral video. A scale of Perceived similarities between oneself and people with schizophrenia was administered. Public stigma was measured with an Essentialism scale and Self-stigma with a scale of self-stereotype association. Mediation analyses showed that the effects of categorial and continuum beliefs on essentialism and self-stereotype association were mediated by perceived similarities. Our results suggest that continuum beliefs about schizophrenia act as a recategorization mechanism, by enhancing perceived similarities with the stereotyped group.",2020,Mediation analyses showed that the effects of categorial and continuum beliefs on essentialism and self-stereotype association were mediated by perceived similarities.,[],[],"['essentialism and self-stereotype association', 'public stigma and increase self-stigma', 'public stigma and self-stigma', 'Public stigma', 'stigma of schizophrenia']",[],[],"[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0038272', 'cui_str': 'Stereotyping'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]",565.0,0.0332623,Mediation analyses showed that the effects of categorial and continuum beliefs on essentialism and self-stereotype association were mediated by perceived similarities.,"[{'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Violeau', 'Affiliation': 'Laboratory of Psychology EA 4139, University of Bordeaux, France. Electronic address: louis.violeau-beaugendre@u-bordeaux.fr.'}, {'ForeName': 'Kevin-Marc', 'Initials': 'KM', 'LastName': 'Valery', 'Affiliation': 'Laboratory of Psychology EA 4139, University of Bordeaux, France; Adult Psychiatric Hospital of Jonzac, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Fournier', 'Affiliation': 'Laboratory of Psychology EA 4139, University of Bordeaux, France; Adult Psychiatric Hospital of Jonzac, France.'}, {'ForeName': 'Antoinette', 'Initials': 'A', 'LastName': 'Prouteau', 'Affiliation': 'Laboratory of Psychology EA 4139, University of Bordeaux, France; Adult Psychiatric Hospital of Jonzac, France.'}]",Schizophrenia research,['10.1016/j.schres.2020.04.014']
51,32355067,Impact of diabetes on clinical outcome among elderly patients with acute coronary syndrome treated with percutaneous coronary intervention: insights from the ELDERLY ACS 2 trial.,"BACKGROUND


Despite recent improvements in percutaneous coronary revascularization and antithrombotic therapies for the treatment of acute coronary syndromes, the outcome is still unsatisfactory in high-risk patients, such as the elderly and patients with diabetes. The aim of the current study was to investigate the prognostic impact of diabetes on clinical outcome among patients included in the Elderly-ACS 2 trial, a randomized, open-label, blinded endpoint study carried out at 32 centers in Italy.
METHODS


Our population is represented by 1443 patients included in the Elderly-ACS 2 trial. Diabetes was defined as known history of diabetes at admission. The primary endpoint of this analysis was cardiovascular mortality, while secondary endpoints were all-cause death, recurrent myocardial infarction, Bleeding Academic Research Consortium type 2 or 3 bleeding, and rehospitalization for cardiovascular event or stent thrombosis within 12 months after index admission.
RESULTS


Diabetes was present in 419 (29%) out of 1443 patients. Diabetic status was significantly associated with major cardiovascular risk factors and history of previous coronary disease, presentation with non-ST segment elevation myocardial infarction (P = 0.01) more extensive coronary disease (P = 0.02), more advanced Killip class at presentation (P = 0.003), use at admission of statins (P = 0.004) and diuretics at discharge (P < 0.001). Median follow-up was 367 days (interquartile range: 337-378 days). Diabetic status was associated with an absolute increase in the rate of cardiovascular mortality as compared with patients without diabetes [5.5 vs. 3.3%, hazard ratio (HR) 1.7 (0.99-2.8), P = 0.054], particularly among those treated with clopidogrel [HR (95% confidence interval (CI)) = 1.89 (0.93-3.87), P = 0.08]. However, this difference disappeared after correction for baseline differences [Adjusted HR (95% CI) 1.1(0.4-2.9), P = 0.86]. Similar findings were observed for other secondary endpoints, except for bleeding complications, significantly more frequent in diabetic patients [HR (95% CI) 2.02 (1.14-3.6), P = 0.02; adjusted HR (95% CI) = 2.1 (1.01-4.3), P = 0.05]. No significant interaction was observed between type of dual antiplatelet therapy, diabetic status and outcome.
CONCLUSION


Among elderly patients with acute coronary syndromes, diabetic status was associated with higher rates of comorbidities, more severe cardiovascular risk profile and major bleeding complications fully accounting for the absolute increase in mortality. In fact, diabetes mellitus did not emerge as an independent predictor of survival in advanced age.",2020,"Diabetic status was associated with an absolute increase in the rate of cardiovascular mortality as compared with patients without diabetes [5.5 vs. 3.3%, hazard ratio (HR) 1.7 (0.99-2.8), P = 0.054], particularly among those treated with clopidogrel [HR (95% confidence interval (CI)) = ","['Diabetes was present in 419 (29%) out of 1443 patients', 'patients included in the Elderly-ACS 2 trial, a randomized, open-label, blinded endpoint study carried out at 32 centers in Italy', '1443 patients included in the Elderly-ACS 2 trial', 'elderly and patients with diabetes', 'elderly patients with acute coronary syndrome treated with', 'elderly patients with acute coronary syndromes']","['percutaneous coronary revascularization and antithrombotic therapies', 'percutaneous coronary intervention']","['extensive coronary disease', 'diabetic patients [HR', 'cause death, recurrent myocardial infarction, Bleeding Academic Research Consortium type 2 or 3 bleeding, and rehospitalization for cardiovascular event or stent thrombosis', 'bleeding complications', 'rate of cardiovascular mortality', 'severe cardiovascular risk profile and major bleeding complications', 'major cardiovascular risk factors and history of previous coronary disease, presentation with non-ST segment elevation myocardial infarction', 'mortality', 'cardiovascular mortality', 'Diabetic status', 'advanced Killip class']","[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0002455', 'cui_str': 'American Cancer Society'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0010068', 'cui_str': 'Coronary Heart Disease'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C1536221', 'cui_str': 'Non ST segment elevation myocardial infarction'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0456387', 'cui_str': 'Class'}]",1443.0,0.0929041,"Diabetic status was associated with an absolute increase in the rate of cardiovascular mortality as compared with patients without diabetes [5.5 vs. 3.3%, hazard ratio (HR) 1.7 (0.99-2.8), P = 0.054], particularly among those treated with clopidogrel [HR (95% confidence interval (CI)) = ","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'De Luca', 'Affiliation': ""Azienda Ospedaliera-Universitaria 'Maggiore della Carità', Eastern Piedmont University, Novara.""}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Verdoia', 'Affiliation': ""Azienda Ospedaliera-Universitaria 'Maggiore della Carità', Eastern Piedmont University, Novara.""}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Savonitto', 'Affiliation': 'Ospedale Manzoni, Lecco.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Piatti', 'Affiliation': 'Ospedale Manzoni, Lecco.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Grosseto', 'Affiliation': 'Ospedale Infermi, Rimini.'}, {'ForeName': 'Nuccia', 'Initials': 'N', 'LastName': 'Morici', 'Affiliation': 'ASST Grande Ospedale Metropolitano Niguarda, Milano.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Bossi', 'Affiliation': 'ASST Grande Ospedale Metropolitano Niguarda, Milano.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Sganzerla', 'Affiliation': 'Ospedale Treviglio-Caravaggio, Treviglio.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Tortorella', 'Affiliation': 'IRCCS Arcispedale S. Maria Nuova, Reggio Emilia.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cacucci', 'Affiliation': 'Ospedale Maggiore, Crema, Italy.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Murena', 'Affiliation': 'Ospedale S. Maria delle Grazie, Pozzuoli, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Toso', 'Affiliation': 'Ospedale S. Stefano, Prato, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Bongioanni', 'Affiliation': 'Ospedale Mauriziano, Torino, Italy.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Ravera', 'Affiliation': ""Ospedale Ruggi D' Aragona, Salerno, Italy.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Corrada', 'Affiliation': 'Humanitas Clinical and Research Center, Rozzano, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Mariani', 'Affiliation': 'Ospedale Civile, Legnano, Italy.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Di Ascenzo', 'Affiliation': 'Ospedale di San Donà di Piave-Portogruaro, Portogruaro, Italy.'}, {'ForeName': 'Anna S', 'Initials': 'AS', 'LastName': 'Petronio', 'Affiliation': 'Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Cavallini', 'Affiliation': 'Ospedale S. Maria della Misericordia, Perugia, Italy.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Vitrella', 'Affiliation': 'Ospedali Riuniti di Trieste, Trieste, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Antonicelli', 'Affiliation': ""Istituto Nazionale di Ricerca e Cura per l' Anziano, Ancona, Italy.""}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Rogacka', 'Affiliation': 'Statistics and Biomathematics Unit, Department of Molecular and Transactional Medicine, University of Brescia, Brescia.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'De Servi', 'Affiliation': 'Multimedica IRCSS, Milan, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Journal of cardiovascular medicine (Hagerstown, Md.)",['10.2459/JCM.0000000000000978']
52,32353115,ACTH Infusion Impairs Baroreflex Sensitivity-Implications for Cardiovascular Hypoglycemia-Associated Autonomic Failure.,"CONTEXT


Hypoglycemia attenuates cardiovascular homeostatic autonomic control. This attenuation, known as the cardiovascular component of hypoglycemia-associated autonomic failure (HAAF), is characterized most notably by decreased baroreflex sensitivity (BRS) that begins during hypoglycemia and persists until at least the next day, despite return to euglycemia. Understanding the mechanisms underlying this reduction in BRS is important because BRS attenuation is associated with increased morbidity and mortality.
OBJECTIVE


The objective of this work is to investigate the role of the adrenocorticotropin (ACTH)-adrenal axis in decreasing BRS. We tested the hypothesis that infusion of ACTH 1-24 (cosyntropin), as compared to placebo, would acutely suppress BRS, and that this decrease in BRS would be present the next day.
DESIGN


A double-blind, placebo-controlled, random-order, cross-over study was conducted.
SETTING


This study took place in a clinical research center.
PARTICIPANTS


Participants included healthy men and women.
INTERVENTIONS


Interventions included an intravenous infusion of cosyntropin (70 μg/hour for 2.5 hours in the morning and again in the early afternoon) vs normal saline placebo.
MAIN OUTCOME MEASURES


Outcome measures included BRS during and 16 hours after cosyntropin vs placebo infusions.
RESULTS


Cosyntropin infusion attenuated BRS (mm Hg/ms) as compared to placebo (baseline 17.8 ± 1.38 vs 17.0 ± 2.07; during 14.4 ± 1.43 vs 17.3 ± 1.65; and next day 14.8 ± 1.42 vs 18.9 ± 2.04; P < .05, time by treatment, analysis of variance). BRS was decreased during the final 30 minutes of the morning cosyntropin infusion as compared to baseline (P < .01) and remained suppressed the next day (16 hours after afternoon infusion) (P < .025). Placebo infusion did not significantly change BRS. Corrected QT interval was not affected.
CONCLUSIONS


ACTH attenuates BRS, raising the possibility that hypoglycemia-induced increases in ACTH may contribute to the cardiovascular component of HAAF.",2020,"QTc was not affected.
",['Healthy men and women'],"['normal saline placebo', 'Placebo', 'ACTH Infusion', 'cosyntropin', 'adrenocorticotropin hormone (ACTH)-adrenal axis', 'placebo']","['change BRS', 'BRS', 'QTc', 'baroreflex sensitivity (BRS']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0199780', 'cui_str': 'Administration of hormone'}, {'cui': 'C0010192', 'cui_str': 'Cosyntropin'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0206162', 'cui_str': 'Baroreceptor reflex'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0860814', 'cui_str': 'QTc'}]",,0.120712,"QTc was not affected.
","[{'ForeName': 'Janet H', 'Initials': 'JH', 'LastName': 'Leung', 'Affiliation': 'Division of Endocrinology and Diabetes, Virginia Mason Medical Center, Seattle, Washington.'}, {'ForeName': 'Omar F', 'Initials': 'OF', 'LastName': 'Bayomy', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Istvan', 'Initials': 'I', 'LastName': 'Bonyhay', 'Affiliation': 'Department of Neurology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Celli', 'Affiliation': 'Department of Neurology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'White', 'Affiliation': 'Department of Neurology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Freeman', 'Affiliation': 'Department of Neurology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Gail K', 'Initials': 'GK', 'LastName': 'Adler', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa221']
53,32353635,Feasibility of decision rule-based treatment of comorbid youth: A pilot randomized control trial.,"This study examined the feasibility, acceptability, and preliminary efficacy of a decision rule driven treatment for youth with comorbid conduct problems and depression. A randomized, controlled, repeated measures design was used to compare two treatment approaches: Decision-Rule Based Treatment (DR) and Sequential Treatment (SEQ). Participants included 30 children (ages 8-14; 66% female; 80% Caucasian) who met criteria for a depressive disorder (major depressive disorder and/or dysthymia) and a conduct problem disorder (oppositional defiant disorder and/or conduct disorder). Assessments were conducted at baseline, post-treatment, and six-month follow-up. Treatment adherence, attendance, and session evaluations ratings indicate that the treatments were feasible to implement and acceptable to parents and youth in both conditions. Both treatments showed similar remission of internalizing and externalizing diagnoses. Participants in DR showed significantly greater improvements at six-month follow-up in child-reported depressive symptom severity compared to SEQ. Both DR and SEQ conditions showed significantly lower behavior problems at end of treatment and six-month follow-up. DR showed significant reductions in emotion dysregulation at 6-month follow-up, while SEQ did not. Findings suggest that a decision rule based intervention holds promise as a feasible and acceptable treatment with high rates of remittance.",2020,"Treatment adherence, attendance, and session evaluations ratings indicate that the treatments were feasible to implement and acceptable to parents and youth in both conditions.","['Participants included 30 children (ages 8-14; 66% female; 80% Caucasian) who met criteria for a depressive disorder (major depressive disorder and/or dysthymia) and a conduct problem disorder (oppositional defiant disorder and/or conduct disorder', 'youth with comorbid conduct problems and depression', 'comorbid youth']",['Decision-Rule Based Treatment (DR) and Sequential Treatment (SEQ'],"['remission of internalizing and externalizing diagnoses', 'behavior problems', 'depressive symptom severity', 'emotion dysregulation']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0013415', 'cui_str': 'Dysthymia'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0029121', 'cui_str': 'Oppositional defiant disorder'}, {'cui': 'C0149654', 'cui_str': 'Conduct disorder'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0522637', 'cui_str': 'Measuring ruler'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",30.0,0.0310239,"Treatment adherence, attendance, and session evaluations ratings indicate that the treatments were feasible to implement and acceptable to parents and youth in both conditions.","[{'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Wolff', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA; Rhode Island Hospital, Providence, RI, USA. Electronic address: jennifer_wolff@brown.edu.'}, {'ForeName': 'Abbe', 'Initials': 'A', 'LastName': 'Garcia', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA; Rhode Island Hospital, Providence, RI, USA.'}, {'ForeName': 'Lourah M', 'Initials': 'LM', 'LastName': 'Kelly', 'Affiliation': 'Rhode Island Hospital, Providence, RI, USA; University of Connecticut Health Center, Farmington, CT, USA.'}, {'ForeName': 'Elisabeth A', 'Initials': 'EA', 'LastName': 'Frazier', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Jones', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Spirito', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103625']
54,32354905,A German Study Comparing Standard Wire Localization With Magnetic Seed Localization of Non-palpable Breast Lesions.,"BACKGROUND


Exact localization of non-palpable breast lesions is necessary to ensure that the correct lesion is removed. Conventional methods come with several disadvantages.
PATIENTS AND METHODS


We compared 28 patients who underwent breast-conserving surgery for a non-palpable lesion. By surgeon choice, 14 patients were assigned to undergo magnetic seed localization and 14 underwent standard wire localization. The primary outcome was the operative time, and secondary outcome was the patient pain level.
RESULTS


The mean age was 52±10 (SD) years in the seed arm, and 55±13 years in the wire arm. The median time from skin incision to tumor extraction was not significantly different between the two groups. Patients in the wire localized group significantly more often reported pain during coughing/breathing, movement, and sleep.
CONCLUSION


Using seed localization at Charité Breast Center did not lead to a significant decrease in operative time but might allow time savings once established, while increasing patient comfort and reducing organizational burden.",2020,"Using seed localization at Charité Breast Center did not lead to a significant decrease in operative time but might allow time savings once established, while increasing patient comfort and reducing organizational burden.","['The mean age was 52±10 (SD) years in the seed arm, and 55±13 years in the wire arm', '28 patients who underwent breast-conserving surgery for a non-palpable lesion']",[],"['pain during coughing/breathing, movement, and sleep', 'patient pain level', 'operative time', 'median time from skin incision to tumor extraction']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0005978', 'cui_str': 'Bone wire'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C0522499', 'cui_str': 'Palpable'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0191279', 'cui_str': 'Incision of skin'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]",28.0,0.130657,"Using seed localization at Charité Breast Center did not lead to a significant decrease in operative time but might allow time savings once established, while increasing patient comfort and reducing organizational burden.","[{'ForeName': 'Friedrich', 'Initials': 'F', 'LastName': 'Kühn', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Clinic for Gynecology with Breast Center, Berlin, Germany.'}, {'ForeName': 'Charlotte Emmi Elisabeth', 'Initials': 'CEE', 'LastName': 'Simon', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Ilhamiyya', 'Initials': 'I', 'LastName': 'Aliyeva', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Clinic for Gynecology with Breast Center, Berlin, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'KUßMAUL', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Clinic for Gynecology with Breast Center, Berlin, Germany.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'GROß', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Clinic for Gynecology with Breast Center, Berlin, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Schweizerhof', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Biometry and Clinical Epidemiology, Berlin, Germany.'}, {'ForeName': 'Jens-Uwe', 'Initials': 'JU', 'LastName': 'Blohmer', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Clinic for Gynecology with Breast Center, Berlin, Germany.'}, {'ForeName': 'Maria Margarete', 'Initials': 'MM', 'LastName': 'Karsten', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Clinic for Gynecology with Breast Center, Berlin, Germany maria-margarete.karsten@charite.de.'}]","In vivo (Athens, Greece)",['10.21873/invivo.11888']
55,32354952,A Randomized Control Trial of Oral Sucrose Solution for Prevention of Hypoglycemia in High Risk Infants.,"BACKGROUND


Neonatal hypoglycemia is found in up to 15% of neonates and 50% of those with risk factors. Hypoglycemia can cause brain damage and increase risk of developmental delay. Nevertheless, the data regarding hypoglycemia prevention by oral sucrose are still limited. The present study aimed to investigate whether oral sucrose solution can prevent hypoglycemia in high-risk infants.
PATIENTS AND METHODS


Four hundred and twenty-five infants with high hypoglycemic risk were randomized into two groups (214 infants in the intervention and 211 infants in the control groups). The intervention group received one dose of 0.8 ml/kg of 24% oral sucrose solution followed by enteral feed and was compared to the control group receiving enteral feed alone. Glucose levels were evaluated by Dextrostrix.
RESULTS


There was no significant difference in antenatal and perinatal risk factors of neonatal hypoglycemia between groups. Glucose level on admission was 72.1±20.3 and 72.1±24.1 mg/dl in the intervention and control groups, respectively. Although no significant difference was recognized in terms of capillary blood glucose levels between groups, data analysis revealed that the glucose increase over time was significantly higher in the intervention group at 1 h (mean±SE=3.61±1.27 mg/dl; p<0.005), 3 h (mean±SE=7.95±1.57 mg/dl, p<0.001), and 6 h (mean±SE=6.31±1.62 mg/dl, p<0.001) in comparison to those of the control. No serious adverse event was observed in either group.
CONCLUSION


A single dose of 24% sucrose solution enhanced the increase of glucose level at 1, 3 and 6 h. However, routine early feeding alone is not inferior to the addition of an oral sucrose solution.",2020,"Although no significant difference was recognized in terms of capillary blood glucose levels between groups, data analysis revealed that the glucose increase over time was significantly higher in the intervention group at 1 h (mean±SE=3.61±1.27 mg/dl; p<0.005), 3 h (mean±SE=7.95±1.57 mg/dl, p<0.001), and 6 h (mean±SE=6.31±1.62 mg/dl, p<0.001) in comparison to those of the control.","['high-risk infants', 'High Risk Infants', 'Four hundred and twenty-five infants with high hypoglycemic risk were randomized into two groups (214 infants in the intervention and 211 infants in the control groups']","['one dose of 0.8 ml/kg of 24% oral sucrose solution followed by enteral feed and was compared to the control group receiving enteral feed alone', 'Oral Sucrose Solution', 'oral sucrose solution']","['Glucose level on admission', 'antenatal and perinatal risk factors of neonatal hypoglycemia', 'capillary blood glucose levels', 'hypoglycemia', 'serious adverse event', 'glucose level', 'Glucose levels', 'glucose increase over time']","[{'cui': 'C0419437', 'cui_str': 'High risk infant'}, {'cui': 'C3844105', 'cui_str': '425'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0457453', 'cui_str': 'On admission'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C1171167', 'cui_str': 'Perinatal risk'}, {'cui': 'C0158986', 'cui_str': 'Neonatal hypoglycemia'}, {'cui': 'C0457578', 'cui_str': 'Capillary blood glucose measurement'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0860803', 'cui_str': 'Glucose increased'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",425.0,0.0363782,"Although no significant difference was recognized in terms of capillary blood glucose levels between groups, data analysis revealed that the glucose increase over time was significantly higher in the intervention group at 1 h (mean±SE=3.61±1.27 mg/dl; p<0.005), 3 h (mean±SE=7.95±1.57 mg/dl, p<0.001), and 6 h (mean±SE=6.31±1.62 mg/dl, p<0.001) in comparison to those of the control.","[{'ForeName': 'Sarivirin', 'Initials': 'S', 'LastName': 'Surachaidungtavil', 'Affiliation': 'Department of Pediatrics, Phramongkutklao Hospital and Phramongkutklao College of Medicine, Bangkok, Thailand.'}, {'ForeName': 'Pithi', 'Initials': 'P', 'LastName': 'Chanvorachote', 'Affiliation': 'Department of Pharmacology and Physiology, Faculty of Pharmaceutical Sciences, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Nithipun', 'Initials': 'N', 'LastName': 'Suksumek', 'Affiliation': 'Department of Pediatrics, Phramongkutklao Hospital and Phramongkutklao College of Medicine, Bangkok, Thailand drnithipun@hotmail.com nithipun@gmail.com.'}]","In vivo (Athens, Greece)",['10.21873/invivo.11935']
56,32354072,mcIRBP-19 of Bitter Melon Peptide Effectively Regulates Diabetes Mellitus (DM) Patients' Blood Sugar Levels.,"This study was conducted to test the effectiveness of a particular bitter melon peptide (BMP), with a specific sequence of 19 amino acids (mcIRBP-19), in regulating diabetic patients' blood glucose. In order to test the product with the specially processed BMP, a total of 142 diabetic patients were solicited as study subjects, of which 64 were assigned to an experiment group and 78 to a control group. Biochemical data were compared with a paired  t- test to verify the significance of changes over different time periods. The clinical results showed that BMP started to improve the subjects' glycated hemoglobin (HbA1c) levels at the end of the second month (T2), with mean values being significantly lowered from 7.8 ± 1.4% (T0) to 7.5 ± 1.4% (T2) ( p  = 0.004). The values reduced continuously, eventually reaching 7.4 ± 1.1% ( p  = 0.000) at the end of the experiment (T3). HbA1c levels for the control group were 7.5 ± 1.2% in T0 and 7.5 ± 1.1% (T3), and not significantly different ( p  = 0.852) over the same period. This study provides clinical evidence that helps to verify the effectiveness of the new BMP product in regulating diabetic patients' blood sugar levels.",2020,"The values reduced continuously, eventually reaching 7.4 ± 1.1% ( p  = 0.000) at the end of the experiment (T3).","[""diabetic patients' blood glucose"", '142 diabetic patients were solicited as study subjects, of which 64 were assigned to an experiment group and 78 to a control group']","['BMP', 'particular bitter melon peptide (BMP), with a specific sequence of 19 amino acids (mcIRBP-19']","[""subjects' glycated hemoglobin (HbA1c) levels"", 'HbA1c levels']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0330482', 'cui_str': 'Momordica charantia'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}]","[{'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",142.0,0.0220155,"The values reduced continuously, eventually reaching 7.4 ± 1.1% ( p  = 0.000) at the end of the experiment (T3).","[{'ForeName': 'Pang-Kuei', 'Initials': 'PK', 'LastName': 'Hsu', 'Affiliation': 'Greenyn Biotechnology Co., Ltd., Taichung City 40768, Taiwan.'}, {'ForeName': 'Frank F C', 'Initials': 'FFC', 'LastName': 'Pan', 'Affiliation': 'Department of Pharmacy and Department of Hospitality, College of Pharmacy and Healthcare, Tajen University, Yanpu, Pingtung County 90741, Taiwan.'}, {'ForeName': 'Ching-Sen', 'Initials': 'CS', 'LastName': 'Hsieh', 'Affiliation': 'Department of Pharmacy and Department of Hospitality, College of Pharmacy and Healthcare, Tajen University, Yanpu, Pingtung County 90741, Taiwan.'}]",Nutrients,['10.3390/nu12051252']
57,32354152,Prebiotic Effects of Partially Hydrolyzed Guar Gum on the Composition and Function of the Human Microbiota-Results from the PAGODA Trial.,"(1) Background: Alterations in the structural composition of the human gut microbiota have been identified in various disease entities along with exciting mechanistic clues by reductionist gnotobiotic modeling. Improving health by beneficially modulating an altered microbiota is a promising treatment approach. Prebiotics, substrates selectively used by host microorganisms conferring a health benefit, are broadly used for dietary and clinical interventions. Herein, we sought to investigate the microbiota-modelling effects of the soluble fiber, partially hydrolyzed guar gum (PHGG). (2) Methods: We performed a 9 week clinical trial in 20 healthy volunteers that included three weeks of a lead-in period, followed by three weeks of an intervention phase, wherein study subjects received 5 g PHGG up to three times per day, and concluding with a three-week washout period. A stool diary was kept on a daily basis, and clinical data along with serum/plasma and stool samples were collected on a weekly basis. PHGG-induced alterations of the gut microbiota were studied by 16S metagenomics of the V1-V3 and V3-V4 regions. To gain functional insight, we further studied stool metabolites using nuclear magnetic resonance (NMR) spectroscopy. (3) Results: In healthy subjects, PHGG had significant effects on stool frequency and consistency. These effects were paralleled by changes in α- (species evenness) and β-diversity (Bray-Curtis distances), along with increasing abundances of metabolites including butyrate, acetate and various amino acids. On a taxonomic level, PHGG intake was associated with a bloom in  Ruminococcus ,  Fusicatenibacter ,  Faecalibacterium  and  Bacteroides  and a reduction in  Roseburia ,  Lachnospiracea  and  Blautia . The majority of effects disappeared after stopping the prebiotic and most effects tended to be more pronounced in male participants. (4) Conclusions: Herein, we describe novel aspects of the prebiotic PHGG on compositional and functional properties of the healthy human microbiota.",2020,"(species evenness) and β-diversity (Bray-Curtis distances), along with increasing abundances of metabolites including butyrate, acetate and various amino acids.","['healthy human microbiota', '20 healthy volunteers', 'male participants']","['nuclear magnetic resonance (NMR) spectroscopy', 'PHGG', 'soluble fiber, partially hydrolyzed guar gum (PHGG', 'Partially Hydrolyzed Guar Gum', 'prebiotic PHGG']","['α', 'stool frequency and consistency', 'abundances of metabolites including butyrate, acetate and various amino acids']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0037812', 'cui_str': 'Analysis, Spectrum'}, {'cui': 'C0061996', 'cui_str': 'guar gum'}, {'cui': 'C3661727', 'cui_str': 'Soluble fiber'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006521', 'cui_str': 'Butyrates'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}]",20.0,0.0740248,"(species evenness) and β-diversity (Bray-Curtis distances), along with increasing abundances of metabolites including butyrate, acetate and various amino acids.","[{'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Reider', 'Affiliation': 'Christian Doppler Laboratory for Mucosal Immunology, Medical University Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Moosmang', 'Affiliation': 'Institute of Pharmacy/Pharmacognosy & Center for Molecular Biosciences Innsbruck, Leopold-Franzens Universität, 6020 Innsbruck, Austria.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Tragust', 'Affiliation': 'Christian Doppler Laboratory for Mucosal Immunology, Medical University Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Lovro', 'Initials': 'L', 'LastName': 'Trgovec-Greif', 'Affiliation': 'Division of Computational Systems Biology, Department of Microbiology, University of Vienna, 1010 Vienna, Austria.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Tragust', 'Affiliation': 'General Zoology/Institute of Biology, University Halle, 06108 Halle/Saale, Germany.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Perschy', 'Affiliation': 'Division of Computational Systems Biology, Department of Microbiology, University of Vienna, 1010 Vienna, Austria.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Przysiecki', 'Affiliation': 'Christian Doppler Laboratory for Mucosal Immunology, Medical University Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Sturm', 'Affiliation': 'Institute of Pharmacy/Pharmacognosy & Center for Molecular Biosciences Innsbruck, Leopold-Franzens Universität, 6020 Innsbruck, Austria.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Tilg', 'Affiliation': 'Department of Internal Medicine I, Gastroenterology, Hepatology, Endocrinology & Metabolism, Medical University Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Stuppner', 'Affiliation': 'Institute of Pharmacy/Pharmacognosy & Center for Molecular Biosciences Innsbruck, Leopold-Franzens Universität, 6020 Innsbruck, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rattei', 'Affiliation': 'Division of Computational Systems Biology, Department of Microbiology, University of Vienna, 1010 Vienna, Austria.'}, {'ForeName': 'Alexander R', 'Initials': 'AR', 'LastName': 'Moschen', 'Affiliation': 'Christian Doppler Laboratory for Mucosal Immunology, Medical University Innsbruck, 6020 Innsbruck, Austria.'}]",Nutrients,['10.3390/nu12051257']
58,32356185,High success rates for the use of sofosbuvir/ombitasvir/paritaprevir/ritonavir + ribavirin and sofosbuvir/simeprevir/daclatasvir + ribavirin in retreatment of chronic hepatitis C infection after unsuccessful sofosbuvir/daclatasvir therapy: a real-life experience.,"The aim of this work was assessment of the efficacy and tolerability of two different regimens for retreatment of hepatitis C virus (HCV) patients who failed to respond to SOF/DCV-based therapy. This prospective study included 104 HCV patients who failed to respond to SOF/DCV-based therapy. Patients were randomly allocated to two groups. Efficacy and tolerability were assessed. The 12-week sustained virological response (SVR12) rates were 96% and 94.4% in groups B and A, respectively, with no significant difference (p = 1.000). Most adverse events reported were mild to moderate, with no deaths during the study. Multi-target direct-acting antiviral (DAA) combinations are efficient for retreatment of HCV patients after failure of SOF/DCV-based therapy in real-world management.ClinicalTrials.gov identifier: NCT02992457.",2020,"The 12-week sustained virological response (SVR12) rates were 96% and 94.4% in groups B and A, respectively, with no significant difference (p = 1.000).","['104 HCV patients who failed to respond to SOF/DCV-based therapy', 'hepatitis C virus (HCV) patients who failed to respond to SOF/DCV-based therapy', 'HCV patients after failure of SOF/DCV-based therapy in real-world management']","['Multi-target direct-acting antiviral (DAA) combinations', 'sofosbuvir/ombitasvir/paritaprevir/ritonavir\u2009+\u2009ribavirin and sofosbuvir/simeprevir/daclatasvir\u2009+\u2009ribavirin']","['virological response (SVR12) rates', 'Efficacy and tolerability', 'efficacy and tolerability']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3252090', 'cui_str': 'daclatasvir'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C3653501', 'cui_str': 'DIRECT ACTING ANTIVIRALS'}, {'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C3864967', 'cui_str': 'ombitasvir, paritaprevir and ritonavir'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C2605855', 'cui_str': 'simeprevir'}, {'cui': 'C3252090', 'cui_str': 'daclatasvir'}]","[{'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",104.0,0.0180318,"The 12-week sustained virological response (SVR12) rates were 96% and 94.4% in groups B and A, respectively, with no significant difference (p = 1.000).","[{'ForeName': 'Ebada Mohamed', 'Initials': 'EM', 'LastName': 'Said', 'Affiliation': 'Hepatology, Gastroenterology and Infectious Diseases Department, Faculty of Medicine, Benha University, Benha, Egypt.'}, {'ForeName': 'Badawy A', 'Initials': 'BA', 'LastName': 'Abdulaziz', 'Affiliation': 'Hepatology, Gastroenterology and Infectious Diseases Department, Faculty of Medicine, Benha University, Benha, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'El Kassas', 'Affiliation': 'Endemic Medicine Department, Faculty of Medicine, Helwan University, Cairo, Egypt.'}, {'ForeName': 'Ibrahim Hussein', 'Initials': 'IH', 'LastName': 'El Attar', 'Affiliation': 'Hepatology, Gastroenterology and Infectious Diseases Department, Faculty of Medicine, Benha University, Benha, Egypt.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Emadeldeen', 'Affiliation': 'National Hepatology and Tropical Medicine Research Institute (NHTMRI), Cairo, Egypt.'}, {'ForeName': 'Sherief M', 'Initials': 'SM', 'LastName': 'Abd-Elsalam', 'Affiliation': 'Tropical Medicine Department, Tanta University, Tanta, Egypt. sherif.abdelbaky@med.tanta.edu.eg.'}]",Archives of virology,['10.1007/s00705-020-04639-x']
59,32242978,Incentive spirometry to prevent acute chest syndrome in adults with sickle cell disease; a randomized controlled trial.,,2020,,['adults with sickle cell disease'],['Incentive spirometry'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}]","[{'cui': 'C0454512', 'cui_str': 'Incentive spirometry'}]",[],,0.151465,,"[{'ForeName': 'Charlotte F J', 'Initials': 'CFJ', 'LastName': 'van Tuijn', 'Affiliation': 'Department of Hematology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Aafke E', 'Initials': 'AE', 'LastName': 'Gaartman', 'Affiliation': 'Department of Hematology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Erfan', 'Initials': 'E', 'LastName': 'Nur', 'Affiliation': 'Department of Hematology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Anita W', 'Initials': 'AW', 'LastName': 'Rijneveld', 'Affiliation': 'Department of Hematology, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Bart J', 'Initials': 'BJ', 'LastName': 'Biemond', 'Affiliation': 'Department of Hematology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}]",American journal of hematology,['10.1002/ajh.25805']
60,32125874,Do Ambient Ozone or Other Pollutants Modify Effects of Controlled Ozone Exposure on Pulmonary Function?,"Rationale:  In a previous trial (MOSES [Multicenter Ozone Study of oldEr Subjects]), 3 hours of controlled ozone (O 3 ) exposure caused concentration-related reductions in lung function with evidence of airway inflammation and injury, but without convincing evidence of effects on cardiovascular function. However, the subjects' exposures to indoor and outdoor air pollution in the hours and days before each controlled O 3  exposure may have modified biomarker responses to the controlled O 3  exposures. Objectives:  We sought to determine whether personal measures of nitrogen dioxide (NO 2 ) and O 3 , or ambient concentrations of O 3 , particulate matter ≤2.5 μm in aerodynamic diameter, NO 2 , carbon monoxide (CO), and sulfur dioxide (SO 2 ) in the 72 and 96 hours before the exposure visit modified biomarker responses to controlled O 3  exposure. Methods:  MOSES subjects were exposed for 3 hours in random order to clean air containing 0 ppb O 3 , 70 ppb O 3 , or 120 ppm O 3 , alternating 15 minutes of moderate exercise with 15 minutes of rest. Cardiovascular and pulmonary endpoints (biomarkers of autonomic function, repolarization, ST segment change, arrhythmia, prothrombotic vascular status, systemic inflammation, vascular function, pulmonary function, oxidative stress, and lung injury) were measured on the day before, the day of, and up to 22 hours after each exposure. We evaluated whether ambient pollutant concentrations in the 96 hours before the pre-exposure visit modified pre- to post-exposure lung function biomarker responses to the controlled O 3  exposures, using tertiles of passive personal exposure samplers (PES) of O 3  and NO 2 , ambient air pollutant concentrations, and mixed effects linear regression. We also similarly explored the effect modification of controlled O 3  effects on biomarkers of other MOSES outcome groups in the same way. Although we used  P  < 0.01 to define statistical significance, we did not formally correct for multiple comparisons. Results:  The effects of MOSES controlled O 3  exposures on forced expiratory volume in 1 second (FEV 1 ) and forced vital capacity (FVC) were modified by ambient NO 2  and CO, and PES NO 2 . Reductions in FEV 1  and FVC were observed only when these concentrations were in the ""medium"" or ""high"" tertile in the 72 hours before the pre-exposure visit. There was no such modification of the effect of controlled O 3  exposure on any other cardiopulmonary outcome group. Conclusions:  Reductions in markers of lung function, but not other pathways, by the MOSES controlled O 3  exposure were modified by ambient NO 2  and CO, and PES NO 2 , and these reductions were observed only when these pollutant concentrations were elevated in the hours and days before the pre-exposure visit.Clinical trial registered with ClinicalTrials.gov (NCT01487005).",2020,"Reductions in FEV 1  and FVC were observed only when these concentrations were in the ""medium"" or ""high"" tertile in the 72 hours before the pre-exposure visit.",['oldEr Subjects'],"['Controlled Ozone Exposure', 'clean air containing 0 ppb O 3 , 70 ppb O 3 , or 120 ppm O 3 , alternating 15 minutes of moderate exercise with 15 minutes of rest']","['personal measures of nitrogen dioxide (NO 2 ) and O 3 , or ambient concentrations of O 3 , particulate matter ≤2.5 μm in aerodynamic diameter, NO 2 , carbon monoxide (CO), and sulfur dioxide (SO 2 ', 'markers of lung function', 'forced expiratory volume in 1 second (FEV 1 ) and forced vital capacity (FVC', 'Cardiovascular and pulmonary endpoints (biomarkers of autonomic function, repolarization, ST segment change, arrhythmia, prothrombotic vascular status, systemic inflammation, vascular function, pulmonary function, oxidative stress, and lung injury', 'FEV 1  and FVC', 'ambient pollutant concentrations']","[{'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0032441', 'cui_str': 'Polybrominated biphenyl'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C1442447', 'cui_str': 'Fifteen minutes'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0028160', 'cui_str': 'Nitrogen dioxide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1720884', 'cui_str': 'Particulate Matter'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0038777', 'cui_str': 'Sulfur Dioxide'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0429029', 'cui_str': 'ST segment'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0273115', 'cui_str': 'Injury of lung'}, {'cui': 'C0014417', 'cui_str': 'Pollutants, Environmental'}]",,0.0286714,"Reductions in FEV 1  and FVC were observed only when these concentrations were in the ""medium"" or ""high"" tertile in the 72 hours before the pre-exposure visit.","[{'ForeName': 'David Q', 'Initials': 'DQ', 'LastName': 'Rich', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Sally W', 'Initials': 'SW', 'LastName': 'Thurston', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Balmes', 'Affiliation': 'University of California at San Francisco, San Francisco, California.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Bromberg', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; and.'}, {'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Arjomandi', 'Affiliation': 'University of California at San Francisco, San Francisco, California.'}, {'ForeName': 'Milan J', 'Initials': 'MJ', 'LastName': 'Hazucha', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; and.'}, {'ForeName': 'Neil E', 'Initials': 'NE', 'LastName': 'Alexis', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; and.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ganz', 'Affiliation': 'University of California at San Francisco, San Francisco, California.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Zareba', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Thevenet-Morrison', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Petros', 'Initials': 'P', 'LastName': 'Koutrakis', 'Affiliation': 'Harvard T. H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Frampton', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201908-597OC']
61,32297590,Rigorous Randomized Controlled Trial Implementation in the Era of COVID-19.,,2020,Rigorous Randomized Controlled Trial Implementation in the Era of Novel Coronavirus Disease (COVID-19).,[],[],[],[],[],[],,0.195176,Rigorous Randomized Controlled Trial Implementation in the Era of Novel Coronavirus Disease (COVID-19).,"[{'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thuy', 'Initials': 'T', 'LastName': 'Doan', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.20-0262']
62,32367175,Impact of a 12-Week Randomized Exercise Training Program on Lipid Profile in Severely Obese Patients Following Bariatric Surgery.,"PURPOSE


The benefit of exercise training on lipid profile in bariatric surgery patients is scarce. We assess the effect of a supervised exercise-training program on lipid profile following bariatric surgery.
MATERIALS AND METHODS


A total of 60 patients were prospectively recruited, of those 49 completed the study (age 41 ± 11 years; body mass index 45.9 ± 6.1 kg/m 2 , 75% women). The bariatric surgery procedures performed were sleeve gastrectomy (SG) (n = 24) and biliopancreatic diversion with duodenal switch (BPD-DS) (n = 25). Of the 49 patients who completed the study, 34 had been randomized to a 12-week supervised exercise training program (exercise group) between the 3rd and the 6th month following bariatric surgery (SG = 17 and BPD-DS = 17). Fasting blood samples and anthropometric measurements were performed preoperatively and at 3, 6, and 12 months after bariatric surgery.
RESULTS


At 6 months and 12 months, percentage of weight loss was similar between groups (6 months: - 29.6 ± 5.5 vs. - 27.8 ± 7.7%; P = 0.371; 12 months: - 38.4 ± 10.4 vs. - 37.9 ± 9.5%; P = 0.876 exercise vs. control). Both groups had an increase in HDL values between the 3nd and the 6th month following bariatric surgery. There was a significantly greater increment in HDL values in the exercise group (0.18 ± 0.14 vs. 0.07 ± 0.12 mmol/L, P = 0.014; exercise vs. control).
CONCLUSION


Our results showed a beneficial effect of a 12-week supervised exercise-training program in bariatric surgery patients showing similar weight loss on HDL-cholesterol levels without additional effect on LDL-cholesterol levels.",2020,"At 6 months and 12 months, percentage of weight loss was similar between groups (6 months: - 29.6 ± 5.5 vs. - 27.8 ± 7.7%; P = 0.371; 12 months: - 38.4 ± 10.4 vs. - 37.9 ± 9.5%; P = 0.876 exercise vs. control).","['bariatric surgery patients', '49 patients who completed the study, 34 had been randomized to a 12-week', 'Severely Obese Patients Following Bariatric Surgery', 'A total of 60 patients were prospectively recruited, of those 49 completed the study (age 41\u2009±\u200911\xa0years; body mass index 45.9\u2009±\u20096.1\xa0kg/m 2 , 75% women']","['exercise training', 'sleeve gastrectomy (SG', 'biliopancreatic diversion with duodenal switch (BPD-DS', 'Exercise Training Program', 'supervised exercise-training program', 'supervised exercise training program (exercise']","['LDL-cholesterol levels', 'HDL values', 'Lipid Profile', 'HDL-cholesterol levels', 'percentage of weight loss', 'Fasting blood samples and anthropometric measurements']","[{'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0005435', 'cui_str': 'Biliopancreatic bypass'}, {'cui': 'C1960687', 'cui_str': 'Duodenal switch'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",60.0,0.0218751,"At 6 months and 12 months, percentage of weight loss was similar between groups (6 months: - 29.6 ± 5.5 vs. - 27.8 ± 7.7%; P = 0.371; 12 months: - 38.4 ± 10.4 vs. - 37.9 ± 9.5%; P = 0.876 exercise vs. control).","[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Tardif', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Québec, Québec, Canada.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Auclair', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Québec, Québec, Canada.'}, {'ForeName': 'Marie-Eve', 'Initials': 'ME', 'LastName': 'Piché', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Québec, Québec, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Biertho', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Québec, Québec, Canada.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Marceau', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Québec, Québec, Canada.'}, {'ForeName': 'Frédéric-Simon', 'Initials': 'FS', 'LastName': 'Hould', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Québec, Québec, Canada.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Biron', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Québec, Québec, Canada.'}, {'ForeName': 'Stéfane', 'Initials': 'S', 'LastName': 'Lebel', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Québec, Québec, Canada.'}, {'ForeName': 'Odette', 'Initials': 'O', 'LastName': 'Lescelleur', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Québec, Québec, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Poirier', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Québec, Québec, Canada. paul.poirier@criucpq.ulaval.ca.'}]",Obesity surgery,['10.1007/s11695-020-04647-5']
63,32358259,Evaluation of total corneal power measurements with a new optical biometer.,"PURPOSE


To evaluate the repeatability and validity of total corneal power measurements (total keratometry [TK]) obtained with a recently introduced optical biometer (IOLMaster 700, Carl Zeiss Meditec AG) to a Scheimpflug device (Pentacam, Oculus).
SETTING


Department of Ophthalmology, Ludwig-Maximilians-University, Munich, Germany.
DESIGN


Prospective randomized controlled trial.
METHODS


The inclusion criteria were a corneal astigmatism of 3.00 diopters (D) or less, no previous ocular surgery, no known corneal irregularities, and no known dry eyes. All eyes were measured 3 times using the optical biometer and the Scheimpflug device. The results were statistically compared using Bland-Altman, within-subject SD, and astigmatism vector analysis.
RESULTS


Ninety-three eyes of 93 subjects were included. Overall, the repeatability of all eyes measured was 0.42 for standard K, 0.40 for TK, 0.45 for total corneal refractive power (TCRP), 0.43 for true net power (TNP), and 0.39 for simulated K. Bland-Altman analysis showed no significant difference between the optical biometer's TK compared with standard K and the Scheimpflug device's simulated K, TNP, and TCRP, the P value exceeding .05 in each case. A difference of >0.50 diopters between astigmatism measurements between TK and TCRP was found in 10 cases compared with standard K and TNP with 0 and 2 cases.
CONCLUSIONS


Repeatability of both devices was high, although measurements of meridian showed a great variability, suggesting that numerous measurements are needed to enhance accuracy. TCRP measurements between recently introduced TK and TCRP cannot be used interchangeably. Future studies are necessary to evaluate which measurement will result in a better outcome when respective measurements are used for toric intraocular lens calculations.",2020,"Overall, the repeatability of all eyes measured was 0.42 for standard K, 0.40 for TK, 0.45 for total corneal refractive power (TCRP), 0.43 for true net power (TNP), and 0.39 for simulated K. Bland-Altman analysis showed no significant difference between the optical biometer's TK compared with standard K and the Scheimpflug device's simulated K, TNP, and TCRP, the P value exceeding .05 in each case.","['Department of Ophthalmology, Ludwig-Maximilians-University, Munich, Germany', 'The inclusion criteria were a corneal astigmatism of 3.00 diopters (D) or less, no previous ocular surgery, no known corneal irregularities, and no known dry eyes', 'Ninety-three eyes of 93 subjects were included']",['total corneal power measurements (total keratometry [TK'],"['total corneal refractive power (TCRP', 'TCRP measurements']","[{'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C0024081', 'cui_str': ""Ludwig's angina""}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0339682', 'cui_str': 'Regular astigmatism - corneal'}, {'cui': 'C0439484', 'cui_str': 'Diopters'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1705869', 'cui_str': 'Ophthalmic surgery'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0430885', 'cui_str': 'Keratometry'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0429520', 'cui_str': 'Refractive power'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",93.0,0.0716156,"Overall, the repeatability of all eyes measured was 0.42 for standard K, 0.40 for TK, 0.45 for total corneal refractive power (TCRP), 0.43 for true net power (TNP), and 0.39 for simulated K. Bland-Altman analysis showed no significant difference between the optical biometer's TK compared with standard K and the Scheimpflug device's simulated K, TNP, and TCRP, the P value exceeding .05 in each case.","[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Shajari', 'Affiliation': 'From the Department of Ophthalmology, Ludwig-Maximilians University (Shajari, Sonntag, Ramsauer, Kreutzer, Vounotrypidis, Priglinger, Mayer), Munich, Department of Ophthalmology (Shajari, Kohnen), Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Ruven', 'Initials': 'R', 'LastName': 'Sonntag', 'Affiliation': ''}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Ramsauer', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kreutzer', 'Affiliation': ''}, {'ForeName': 'Efstathios', 'Initials': 'E', 'LastName': 'Vounotrypidis', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kohnen', 'Affiliation': ''}, {'ForeName': 'Siegfried', 'Initials': 'S', 'LastName': 'Priglinger', 'Affiliation': ''}, {'ForeName': 'Wolfgang J', 'Initials': 'WJ', 'LastName': 'Mayer', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000136']
64,32358262,Comparison of visual and refractive outcomes of 2 trifocal intraocular lenses.,"PURPOSE


To compare clinical outcomes after cataract surgery and bilateral implantation of 2 diffractive trifocal toric intraocular lenses (IOLs).
SETTING


Hospital da Luz, Lisbon, Portugal.
DESIGN


Double-arm, randomized, prospective case series.
METHODS


A total of 60 patients were randomly allocated to receive bilateral implantation of either the FineVision Pod FT toric IOL (PhysIOL) or the AcrySof IQ PanOptix toric IOL (Alcon). Visual and refractive outcomes, contrast sensitivity, IOL misalignment, and quality of vision outcomes (QoV questionnaire) were evaluated at 3 months postoperatively. Surgically induced astigmatic changes were evaluated by vector analysis.
RESULTS


Each group (FineVision toric and AcrySof IQ PanOptix toric) comprised 30 patients (60 eyes). No significant differences between groups were found regarding uncorrected and corrected distance and near visual outcomes (P ≥ .333). Mean postoperative distance-corrected intermediate visual acuity at 60 cm was 0.04 ± 0.09 logarithm of the minimum angle of resolution (logMAR) and 0.09 ± 0.11 logMAR in the PanOptix and Pod FT group, respectively (P = .032). Mean IOL axis misalignment was 1.59 degrees ± 2.15 degrees (PanOptix group) and 1.89 degrees ± 3.31 degrees (Pod FT group) (P = .821). Mean magnitude of error of astigmatic correction was -0.09 diopters (D) and -0.11 D in the PanOptix group and Pod FT group, respectively (P = .333). Contrast sensitivity, QoV scores for the presence of photic phenomena, and the level of spectacle independence were similar in both groups (P > .05).
CONCLUSIONS


Both trifocal toric IOLs allowed complete patient visual restoration, and good spectacle independence and good visual quality outcomes. The PanOptix IOL provided superior intermediate visual acuity for distances around 60 cm.",2020,No significant differences between groups were found regarding uncorrected and corrected distance and near visual outcomes (P ≥ .333).,"['30 patients (60 eyes', 'Hospital da Luz, Lisbon, Portugal', '60 patients']","['2 trifocal intraocular lenses', 'cataract surgery and bilateral implantation of 2 diffractive trifocal toric intraocular lenses (IOLs', 'bilateral implantation of either the FineVision Pod FT toric IOL (PhysIOL) or the AcrySof IQ PanOptix toric IOL (Alcon']","['Mean IOL axis misalignment', 'Mean magnitude of error of astigmatic correction', 'Visual and refractive outcomes, contrast sensitivity, IOL misalignment, and quality of vision outcomes (QoV questionnaire', 'corrected distance and near visual outcomes', 'Contrast sensitivity, QoV scores', 'astigmatic changes', 'Mean postoperative distance-corrected intermediate visual acuity', 'complete patient visual restoration, and good spectacle independence and good visual quality outcomes', 'level of spectacle independence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0032729', 'cui_str': 'Portugal'}]","[{'cui': 'C1275646', 'cui_str': 'Trifocal glasses'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C1275957', 'cui_str': 'Misalignment'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1690987', 'cui_str': 'Intermediate visual acuity'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",60.0,0.0784492,No significant differences between groups were found regarding uncorrected and corrected distance and near visual outcomes (P ≥ .333).,"[{'ForeName': 'Filomena J', 'Initials': 'FJ', 'LastName': 'Ribeiro', 'Affiliation': 'From the Department of Ophthalmology, Hospital da Luz, Lisbon, Portugal.'}, {'ForeName': 'Tiago B', 'Initials': 'TB', 'LastName': 'Ferreira', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000118']
65,32358267,Influence of angle κ on visual and refractive outcomes after implantation of a diffractive trifocal intraocular lens.,"PURPOSE


To evaluate changes in angle κ after the implantation of a trifocal intraocular lens (IOL) and to assess the postoperative outcomes of patients with different angle κ values.
SETTING


IOA Madrid Innova Ocular, Madrid, Spain.
DESIGN


Prospective trial.
METHODS


Sixty-three eyes from 63 patients who had bilateral implantation of a diffractive trifocal IOL (POD F, PhysIOL) were included. Pupil offset was used as the best estimate of angle κ and was measured using Pentacam (Oculus) preoperatively and at 3 months postoperatively. Postoperative refractive outcomes (sphere, cylinder, and manifest refraction spherical equivalent) and visual outcomes at far, intermediate, and near distance were assessed and compared between eyes with small pupil offset and eyes with large pupil offset. Quality of vision was assessed using a subjective questionnaire.
RESULTS


There was a significant decrease in pupil offset values postoperatively (mean: 0.197 ± 0.12 mm) compared with those preoperatively (mean: 0.239 ± 0.12 mm), with a mean decrease of -0.042 mm (P = .0002). The same significant decrease was found for both right and left eyes, when analyzed separately. No statistically significant difference was found in any of the refractive and visual acuity outcomes between eyes with small pupil offset and eyes with large pupil offset. The majority of patients (14 of 16) complaining of significant halos had eyes with small pupil offset.
CONCLUSIONS


Large pupil offset did not negatively affect visual and refractive outcomes. The tolerance to larger pupil offset might be due to the IOL optical design, with the first diffractive ring being larger than other commonly used multifocal IOLs. More studies comparing various diffractive IOL models would be useful to confirm such hypothesis.",2020,No statistically significant difference was found in any of the refractive and visual acuity outcomes between eyes with small pupil offset and eyes with large pupil offset.,"['IOA Madrid Innova Ocular, Madrid, Spain', 'Sixty-three eyes from 63 patients who had bilateral implantation of a diffractive trifocal IOL (POD F, PhysIOL) were included', 'patients with different angle κ values']",['trifocal intraocular lens (IOL'],"['Postoperative refractive outcomes (sphere, cylinder, and manifest refraction spherical equivalent) and visual outcomes at far, intermediate, and near distance', 'visual and refractive outcomes', 'pupil offset values', 'Quality of vision', 'refractive and visual acuity outcomes']","[{'cui': 'C0648637', 'cui_str': 'isooctyl acrylate'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1275646', 'cui_str': 'Trifocal glasses'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]","[{'cui': 'C1275646', 'cui_str': 'Trifocal glasses'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0181797', 'cui_str': 'Medical gas cylinder'}, {'cui': 'C1301318', 'cui_str': 'Subjective refraction'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}]",63.0,0.0391853,No statistically significant difference was found in any of the refractive and visual acuity outcomes between eyes with small pupil offset and eyes with large pupil offset.,"[{'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Garzón', 'Affiliation': 'From the IOA Madrid Innova Ocular (Garzón, López-Artero, Poyales); Department of Optica II, Complutense University, Madrid (Garzón, García-Montero); Clínica Oftalmológica Dr Gonzalo Muñoz, Valencia (Albarrán-Diego); Department of Ophthalmology (Oftalmar), Vithas Medimar International Hospital, Alicante (Pérez-Cambrodí); and Begitek, Innova Ocular (Illarramendi), Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'García-Montero', 'Affiliation': ''}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'López-Artero', 'Affiliation': ''}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Albarrán-Diego', 'Affiliation': ''}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Pérez-Cambrodí', 'Affiliation': ''}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Illarramendi', 'Affiliation': ''}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Poyales', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000156']
66,32356084,Is Essentialism Essential? Reducing Homonegative Prejudice by Targeting Diverse Sexual Orientation Beliefs.,"We conducted an experiment to assess whether targeting multiple beliefs about sexual orientation (SO) may be more effective in reducing homonegativity than focusing only on beliefs about its biogenetic origins. Participants (116 women, 85 men) were randomly assigned to one of three treatment conditions or a control condition. Those in the treatment conditions read essays summarizing: (1) research suggesting SO has biogenetic origins, (2) research suggesting SO is socially constructed and refuting beliefs about the discreteness, homogeneity, and informativeness of SO categories; or (3) research suggesting SO is biogenetic and research suggesting SO categories are socially constructed and not necessarily discrete, homogenous, or informative. We predicted participants in the conditions that targeted multiple beliefs related to the social construction of SO, not just its biogenetic origins, would exhibit the strongest reductions in beliefs about the discreteness, homogeneity, and informativeness of SO categories, and in homonegativity. We also predicted these participants would exhibit the greatest increases in support for gay and lesbian civil rights. We observed hypothesized shifts in SO beliefs across all experimental conditions. While there was a small main effect of time on homonegative prejudice, there was no main effect of condition and no changes in support for gay and lesbian civil rights. However, post hoc analyses suggested the two conditions addressing social constructionist beliefs accounted for most of the observed prejudice reduction. Implications for more comprehensive educational and social interventions designed to promote social justice for sexual minorities are discussed.",2020,"However, post hoc analyses suggested the two conditions addressing social constructionist beliefs accounted for most of the observed prejudice reduction.","['Participants (116 women, 85 men']",[],[],"[{'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}]",[],[],116.0,0.0209656,"However, post hoc analyses suggested the two conditions addressing social constructionist beliefs accounted for most of the observed prejudice reduction.","[{'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Fry', 'Affiliation': 'Department of Psychology, University of Tennessee, Knoxville, 1404 Circle Drive, Knoxville, TN, 37996, USA.'}, {'ForeName': 'Patrick R', 'Initials': 'PR', 'LastName': 'Grzanka', 'Affiliation': 'Department of Psychology, University of Tennessee, Knoxville, 1404 Circle Drive, Knoxville, TN, 37996, USA. patrick.grzanka@utk.edu.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Miles', 'Affiliation': 'Department of Psychology, University of Tennessee, Knoxville, 1404 Circle Drive, Knoxville, TN, 37996, USA.'}, {'ForeName': 'Elliott N', 'Initials': 'EN', 'LastName': 'DeVore', 'Affiliation': 'Department of Psychology, University of Tennessee, Knoxville, 1404 Circle Drive, Knoxville, TN, 37996, USA.'}]",Archives of sexual behavior,['10.1007/s10508-020-01706-x']
67,32356115,Poor prognostic factors in predicting abatacept response in a phase III randomized controlled trial in psoriatic arthritis.,"In ASTRAEA (NCT01860976), abatacept significantly increased American College of Rheumatology criteria 20% (ACR20) responses at Week 24 versus placebo in patients with psoriatic arthritis (PsA). This post hoc analysis explored relationships between prospectively identified baseline characteristics [poor prognostic factors (PPFs) ] and response to abatacept. Patients were randomized (1:1) to receive subcutaneous abatacept 125 mg weekly or placebo for 24 weeks; those without ≥ 20% improvement in joint counts at Week 16 switched to open-label abatacept. Potential predictors of ACR20 response were identified by treatment arm using multivariate analyses. Likelihood of ACR20 response to abatacept versus placebo was compared in univariate and multivariate analyses in subgroups stratified by the PPF, as defined by EULAR and/or GRAPPA treatment guidelines. Odds ratios (ORs) were generated using logistic regression to identify meaningful differences (OR cut-off: 1.2). 424 patients were randomized and treated (abatacept n = 213; placebo n = 211). In abatacept-treated patients, elevated C-reactive protein (CRP), high Disease Activity Score based on 28 joints (CRP), presence of dactylitis, and ≥ 3 joint erosions were identified as predictors of response (OR > 1.2). In placebo-treated patients, only dactylitis was a potential predictor of response. In the univariate analysis stratified by PPF, ACR20 response was more likely (OR > 1.2) with abatacept versus placebo in patients with baseline PPFs than in those without; multivariate analysis confirmed this finding. Response to abatacept versus placebo is more likely in patients with features indicative of high disease activity and progressive disease; these characteristics are recognized as PPFs in treatment guidelines for PsA.",2020,"In the univariate analysis stratified by PPF, ACR20 response was more likely (OR > 1.2) with abatacept versus placebo in patients with baseline PPFs than in those without; multivariate analysis confirmed this finding.","['424 patients', 'psoriatic arthritis', 'patients with psoriatic arthritis (PsA']","['subcutaneous abatacept 125\xa0mg weekly or placebo', 'placebo']","['ACR20 response', 'elevated C-reactive protein (CRP), high Disease Activity Score based on 28 joints (CRP), presence of dactylitis, and\u2009≥\u20093 joint erosions', 'Odds ratios (ORs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1619966', 'cui_str': 'abatacept'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0742906', 'cui_str': 'Elevated C-reactive protein'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0239161', 'cui_str': 'Dactylitis'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",424.0,0.122464,"In the univariate analysis stratified by PPF, ACR20 response was more likely (OR > 1.2) with abatacept versus placebo in patients with baseline PPFs than in those without; multivariate analysis confirmed this finding.","[{'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Swedish Medical Center, University of Washington School of Medicine, Seattle, WA, USA. pmease@philipmease.com.'}, {'ForeName': 'Iain B', 'Initials': 'IB', 'LastName': 'McInnes', 'Affiliation': 'Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Strand', 'Affiliation': 'Division of Immunology and Rheumatology, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'FitzGerald', 'Affiliation': ""St. Vincent's University Hospital, The Conway Institute for Biomolecular Research, and University College Dublin, Dublin, Ireland.""}, {'ForeName': 'Harris A', 'Initials': 'HA', 'LastName': 'Ahmad', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Yedid', 'Initials': 'Y', 'LastName': 'Elbez', 'Affiliation': 'Excelya, Boulogne-Billancourt, France.'}, {'ForeName': 'Subhashis', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}]",Rheumatology international,['10.1007/s00296-020-04564-x']
68,32368942,Isokinetic Strength Comparison of Tuberosity Fractures of the Proximal Fifth Metatarsal Treated With Elastic Bandage vs Cast.,"BACKGROUND


The aim of this study was to compare the strength of injured and healthy ankle muscle as well as functional and clinical outcomes between patients with proximal fifth metatarsal tuberosity fractures who received elastic bandage treatment and those who received cast immobilization.
METHODS


Sixty-five patients who presented to our clinic between February 2018 and April 2019 were randomly divided into 2 groups: 33 received elastic bandages (group 1) and 32 received cast immobilization (group 2). All patients were scheduled for follow-up appointments at our clinic after 2, 4, 8, 12, and 24 weeks. Visual analog scale-foot and ankle (VAS-FA) score, time missed from work, and using assistive devices were recorded as clinical outcomes. Both ankle plantarflexion-dorsiflexion and inversion-eversion muscle strengths (peak torque) were measured using an isokinetic dynamometer for each group and were compared with those of the healthy extremities.
RESULTS


The mean missed work was 11.3 days in group 1 and 27.6 days in group 2. Groups 1 and 2 used assistive devices for a mean of 6.7 and 16.2 days, respectively ( P  = .001). Group 1 had a significantly higher VAS-FA score at the 2nd, 4th, and 8th week of follow-up compared with group 2, and no significant differences were observed at the time of injury and at the 12th and 24th weeks. The muscle strength deficits in group 1 were present at the 4th week, whereas those in the cast immobilization group were determined at the 4th and 8th weeks in all muscles. During the 12th and 24th week of follow-up, no significantly differences in both extremities were observed between the groups.
CONCLUSION


Elastic bandage treatment was better than cast immobilization in terms of preserving ankle muscle strength, clinical outcomes, and functional scores regardless of the degree of fracture displacement. Moreover, the present study emphasized that cast immobilization offered no advantages in this fracture treatment.
LEVEL OF EVIDENCE


Level I, prognostic randomized controlled trial.",2020,"Both ankle plantarflexion-dorsiflexion and inversion-eversion muscle strengths (peak torque) were measured using an isokinetic dynamometer for each group and were compared with those of the healthy extremities.
","['Sixty-five patients who presented to our clinic between February 2018 and April 2019', 'patients with proximal fifth metatarsal tuberosity fractures who received']","['ankle plantarflexion-dorsiflexion and inversion-eversion muscle strengths (peak torque', 'elastic bandage treatment and those who received cast immobilization', 'Elastic Bandage vs Cast', 'Elastic bandage', 'cast immobilization', 'elastic bandages']","['VAS-FA score', 'mean missed work', 'Visual analog scale-foot and ankle (VAS-FA) score, time missed from work, and using assistive devices', 'muscle strength deficits']","[{'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0459705', 'cui_str': 'Fifth metatarsal structure'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0021943', 'cui_str': 'Chromosome inversion'}, {'cui': 'C0015211', 'cui_str': 'Eversion'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0336591', 'cui_str': 'Elastic bandage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1283330', 'cui_str': 'Absenteeism at work'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0036605', 'cui_str': 'Assistive equipment'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",65.0,0.0314114,"Both ankle plantarflexion-dorsiflexion and inversion-eversion muscle strengths (peak torque) were measured using an isokinetic dynamometer for each group and were compared with those of the healthy extremities.
","[{'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Bayram', 'Affiliation': 'Department of Orthopedics and Traumatology, Istanbul University Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Alper Şükrü', 'Initials': 'AŞ', 'LastName': 'Kendirci', 'Affiliation': 'Department of Orthopedics and Traumatology, Istanbul University Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Doğan', 'Initials': 'D', 'LastName': 'Kıral', 'Affiliation': 'Department of Orthopedics and Traumatology, Istanbul University Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Türker', 'Initials': 'T', 'LastName': 'Şahinkaya', 'Affiliation': 'Department of Sports Medicine, Istanbul University Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Ekinci', 'Affiliation': 'Department of Orthopedics and Traumatology, Istanbul University Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Sefa Giray', 'Initials': 'SG', 'LastName': 'Batıbay', 'Affiliation': 'Department of Orthopedics and Traumatology, Ankara Occupational and Environmental Diseases Hospital, Ankara, Turkey.'}, {'ForeName': 'Turgut', 'Initials': 'T', 'LastName': 'Akgül', 'Affiliation': 'Department of Orthopedics and Traumatology, Istanbul University Faculty of Medicine, Istanbul, Turkey.'}]",Foot & ankle international,['10.1177/1071100720916429']
69,32356023,"The effect of caffeine on cognitive performance is influenced by CYP1A2 but not ADORA2A genotype, yet neither genotype affects exercise performance in healthy adults.","PURPOSE


To determine the influence of two commonly occurring genetic polymorphisms on exercise, cognitive performance, and caffeine metabolism, after caffeine ingestion.
METHODS


Eighteen adults received caffeine or placebo (3 mg kg -1 ) in a randomised crossover study, with measures of endurance exercise (15-min cycling time trial; 70-min post-supplementation) and cognitive performance (psychomotor vigilance test; PVT; pre, 50 and 95-min post-supplementation). Serum caffeine and paraxanthine were measured (pre, 30 and 120-min post-supplementation), and polymorphisms in ADORA2A (rs5751876) and CYP1A2 (rs762551) genes analysed.
RESULTS


Caffeine enhanced exercise performance (P < 0.001), but effects were not different between participants with ADORA2A 'high' (n = 11) vs. 'low' (n = 7) sensitivity genotype (+ 6.4 ± 5.8 vs. + 8.2 ± 6.8%), or CYP1A2 'fast' (n = 10) vs. 'slow' (n = 8) metabolism genotype (+ 7.2 ± 5.9 vs. + 7.0 ± 6.7%, P > 0.05). Caffeine enhanced PVT performance (P < 0.01). The effect of caffeine was greater for CYP1A2 'fast' vs. 'slow' metabolisers for reaction time during exercise (- 18 ± 9 vs. - 1.0 ± 11 ms); fastest 10% reaction time at rest (- 18 ± 11 vs. - 3 ± 15 ms) and lapses at rest (- 3.8 ± 2.7 vs. + 0.4 ± 0.9) (P < 0.05). There were no PVT differences between ADORA2A genotypes (P > 0.05). Serum caffeine and paraxanthine responses were not different between genotypes (P > 0.05).
CONCLUSION


Caffeine enhanced CYP1A2 'fast' metabolisers' cognitive performance more than 'slow' metabolisers. No other between-genotype differences emerged for the effect of caffeine on exercise or cognitive performance, or metabolism.",2020,"RESULTS


Caffeine enhanced exercise performance (P < 0.001), but effects were not different between participants with ADORA2A 'high' (n = 11) vs. 'low' (n = 7) sensitivity genotype (+ 6.4 ± 5.8 vs. + 8.2 ± 6.8%), or CYP1A2 'fast' (n = 10) vs. 'slow' (n = 8) metabolism genotype (+ 7.2 ± 5.9 vs. + 7.0 ± 6.7%, P > 0.05).","['Eighteen adults received', 'healthy adults']","['endurance exercise (15-min cycling time trial; 70-min post-supplementation) and cognitive performance (psychomotor vigilance test; PVT; pre, 50 and 95-min post-supplementation', 'caffeine', 'caffeine or placebo', 'Caffeine']","['Serum caffeine and paraxanthine', 'cognitive performance', 'exercise or cognitive performance, or metabolism', 'exercise, cognitive performance, and caffeine metabolism', 'Serum caffeine and paraxanthine responses', 'PVT performance', 'exercise performance']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0044060', 'cui_str': '1,7-dimethylxanthine'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",18.0,0.140491,"RESULTS


Caffeine enhanced exercise performance (P < 0.001), but effects were not different between participants with ADORA2A 'high' (n = 11) vs. 'low' (n = 7) sensitivity genotype (+ 6.4 ± 5.8 vs. + 8.2 ± 6.8%), or CYP1A2 'fast' (n = 10) vs. 'slow' (n = 8) metabolism genotype (+ 7.2 ± 5.9 vs. + 7.0 ± 6.7%, P > 0.05).","[{'ForeName': 'Alexander T', 'Initials': 'AT', 'LastName': 'Carswell', 'Affiliation': 'Endurance Research Group, School of Sport and Exercise Sciences, University of Kent, Chatham, Kent, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Howland', 'Affiliation': 'School of Biosciences, University of Kent, Canterbury, Kent, UK.'}, {'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Martinez-Gonzalez', 'Affiliation': 'Endurance Research Group, School of Sport and Exercise Sciences, University of Kent, Chatham, Kent, UK.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Baron', 'Affiliation': 'Endurance Research Group, School of Sport and Exercise Sciences, University of Kent, Chatham, Kent, UK.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Davison', 'Affiliation': 'Endurance Research Group, School of Sport and Exercise Sciences, University of Kent, Chatham, Kent, UK. g.davison@kent.ac.uk.'}]",European journal of applied physiology,['10.1007/s00421-020-04384-8']
70,32357559,"Efficacy and Safety of a 0.1% Tacrolimus Nasal Ointment as a Treatment for Epistaxis in Hereditary Hemorrhagic Telangiectasia: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Trial.","Hereditary hemorrhagic telangiectasia is a rare but ubiquitous genetic disease. Epistaxis is the most frequent and life-threatening manifestation and tacrolimus, an immunosuppressive agent, appears to be an interesting new treatment option because of its anti-angiogenic properties. Our objective was to evaluate, six weeks after the end of the treatment, the efficacy on the duration of nosebleeds of tacrolimus nasal ointment, administered for six weeks to patients with hereditary hemorrhagic telangiectasia complicated by nosebleeds, and we performed a prospective, multicenter, randomized, placebo-controlled, double-blinded, ratio 1:1 phase II study. Patients were recruited from three French Hereditary Hemorrhagic Telangiectasia (HHT) centers between May 2017 and August 2018, with a six-week follow-up, and we included people aged over 18 years, diagnosed with hereditary hemorrhagic telangiectasia and epistaxis (total duration > 30 min/6 weeks prior to inclusion). Tacrolimus ointment 0.1% was self-administered by the patients twice daily. About 0.1 g of product was to be administered in each nostril with a cotton swab. A total of 50 patients was randomized and treated. Mean epistaxis duration before and after treatment in the tacrolimus group were 324.64 and 249.14 min, respectively, and in the placebo group 224.69 and 188.14 min, respectively. Epistaxis duration improved in both groups, with no significant difference in our main objective comparing epistaxis before and after treatment ( p =  0.77); however, there was a significant difference in evolution when comparing epistaxis before and during treatment ( p =  0.04). Toxicity was low and no severe adverse events were reported. In conclusion, tacrolimus nasal ointment, administered for six weeks, did not improve epistaxis in HHT patients after the end of the treatment. However, the good tolerance, associated with a significant improvement in epistaxis duration during treatment, encouraged us to perform a phase 3 trial on a larger patient population with a main outcome of epistaxis duration during treatment and a longer treatment time.",2020,"Epistaxis duration improved in both groups, with no significant difference in our main objective comparing epistaxis before and after treatment ( p =  0.77); however, there was a significant difference in evolution when comparing epistaxis before and during treatment ( p =  0.04).","['patients with hereditary hemorrhagic telangiectasia complicated by nosebleeds', '50 patients', 'Patients were recruited from three French Hereditary Hemorrhagic Telangiectasia (HHT) centers between May 2017 and August 2018, with a six-week follow-up, and we included people aged over 18 years, diagnosed with hereditary hemorrhagic telangiectasia and epistaxis', 'Epistaxis in Hereditary Hemorrhagic Telangiectasia']","['tacrolimus nasal ointment', 'Placebo', 'Tacrolimus Nasal Ointment', 'tacrolimus', 'Tacrolimus ointment', 'placebo']","['Efficacy and Safety', 'epistaxis', 'severe adverse events', 'Toxicity', 'epistaxis duration', 'Epistaxis duration', 'Mean epistaxis duration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039445', 'cui_str': 'Osler hemorrhagic telangiectasia syndrome'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0014591', 'cui_str': 'Bleeding from nose'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0039446', 'cui_str': 'Telangiectasis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205136', 'cui_str': 'Over'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0991527', 'cui_str': 'Nasal ointment'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1253468', 'cui_str': 'Tacrolimus Topical Ointment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",50.0,0.310066,"Epistaxis duration improved in both groups, with no significant difference in our main objective comparing epistaxis before and after treatment ( p =  0.77); however, there was a significant difference in evolution when comparing epistaxis before and during treatment ( p =  0.04).","[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Dupuis-Girod', 'Affiliation': 'Hospices Civils de Lyon, Hôpital Femme-Mère-Enfants, Service de Génétique et Centre de Référence de la Maladie de Rendu-Osler, F-69677 Bron, France.'}, {'ForeName': 'Anne-Emmanuelle', 'Initials': 'AE', 'LastName': 'Fargeton', 'Affiliation': 'Hospices Civils de Lyon, Hôpital Femme-Mère-Enfants, Service de Génétique et Centre de Référence de la Maladie de Rendu-Osler, F-69677 Bron, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Grobost', 'Affiliation': 'Service de Médecine Interne, CHU Estaing, 63100 Clermont-Ferrand, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Rivière', 'Affiliation': ""Service de Médecine Interne CHU de Montpellier, Hôpital St Eloi, and Centre d'Investigation Clinique, Inserm, CIC 1411, F-34295 Montpellier CEDEX 7, France.""}, {'ForeName': 'Marjolaine', 'Initials': 'M', 'LastName': 'Beaudoin', 'Affiliation': 'Hospices Civils de Lyon, Hôpital Femme-Mère-Enfants, Service de Génétique et Centre de Référence de la Maladie de Rendu-Osler, F-69677 Bron, France.'}, {'ForeName': 'Evelyne', 'Initials': 'E', 'LastName': 'Decullier', 'Affiliation': 'Hospices Civils de Lyon, Pôle Santé Publique, F-69003 Lyon, France.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Bernard', 'Affiliation': 'Hospices Civils de Lyon, Pôle Santé Publique, F-69003 Lyon, France.'}, {'ForeName': 'Valentine', 'Initials': 'V', 'LastName': 'Bréant', 'Affiliation': 'Hospices Civils de Lyon, Pharmacie, Hôpital Louis Pradel, F-69677 Bron, France.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Colombet', 'Affiliation': 'Hospices Civils de Lyon, Pharmacie, Hôpital Louis Pradel, F-69677 Bron, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Philouze', 'Affiliation': 'Hospices Civils de Lyon, Hôpital de la Croix Rousse, Service ORL, F-69317 Lyon, France.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Bailly', 'Affiliation': 'Inserm, CEA, Laboratory Biology of Cancer and Infection, University, Grenoble Alpes, F-38000 Grenoble, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Faure', 'Affiliation': 'Hospices Civils de Lyon, Hôpital E. Herriot, Service ORL, F-69437 Lyon, France.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Hermann', 'Affiliation': 'Hospices Civils de Lyon, Hôpital E. Herriot, Service ORL, F-69437 Lyon, France.'}]",Journal of clinical medicine,['10.3390/jcm9051262']
71,32357579,Are Vitamin D 3  Tablets and Oil Drops Equally Effective in Raising S-25-Hydroxyvitamin D Concentrations? A Post-Hoc Analysis of an Observational Study on Immunodeficient Patients.,"BACKGROUND


Vitamin D 3  supplements are available as tablets or oil drops, but there is no consensus as to whether either of these preparations is more effective than the other.
METHODS


We compared the effectiveness of tablets versus oil in raising S-25-hydroxyvitamin D (S-25-OHD) in plasma by re-analyzing data from a previously performed observational study in which immunodeficient patients with S-25-OHD concentrations <75 nmol/L were randomly prescribed vitamin D 3  tablets (1600 IU/day) or vitamin D 3  oil-drops (1500 IU/day) for twelve months. Tablets and oil were compared for the effect on S-25-OHD concentrations after 3-5 months and antibiotic use.
RESULTS


Data on S-25-OHD after ≥ 3 months was available for 137 patients treated with tablets and 69 with oil drops. Both groups exhibited a significant increase in S-25-OHD-oil-drops from 55 to 86 nmol/L and tablets from 52 to 87 nmol/L-with no difference between groups ( p  = 0.77). In a subgroup of patients without immunoglobulin replacement, vitamin D 3  supplementation with oil drops ( n  = 34) but not with tablets ( n  = 60) resulted in significantly lower antibiotic administration ( p  < 0.001 and  p  = 0.58).
CONCLUSION


Vitamin D 3  supplementation with tablets and oil drops were equally efficient in raising S-25-OHD concentrations. Only oil drops caused a reduction in antibiotic consumption in immuno-deficient patients who did not receive immunoglobulin replacement.",2020,Both groups exhibited a significant increase in S-25-OHD-oil-drops from 55 to 86 nmol/L and tablets from 52 to 87 nmol/L-with no difference between groups ( p  = 0.77).,"['Immunodeficient Patients', 'immunodeficient patients with S-25-OHD concentrations <75 nmol', '137 patients treated with tablets and 69 with oil drops']","['vitamin D 3  supplementation with oil drops', 'Vitamin D 3  supplementation with tablets and oil drops', 'vitamin D 3  tablets', 'vitamin D 3  oil-drops']","['antibiotic administration', 'S-25-OHD concentrations', 'S-25-OHD-oil-drops', 'raising S-25-OHD concentrations', 'antibiotic consumption']","[{'cui': 'C0021051', 'cui_str': 'Immunodeficiency disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1859049', 'cui_str': 'Haddad syndrome'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439191', 'cui_str': 'nmol'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0199779', 'cui_str': 'Administration of antibiotic'}, {'cui': 'C1859049', 'cui_str': 'Haddad syndrome'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.306117,Both groups exhibited a significant increase in S-25-OHD-oil-drops from 55 to 86 nmol/L and tablets from 52 to 87 nmol/L-with no difference between groups ( p  = 0.77).,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Helde Frankling', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society (NVS), Division of Clinical Geriatrics, Blickagången 16, Neo floor 7, SE-141 83 Huddinge, Sweden.'}, {'ForeName': 'Anna-Carin', 'Initials': 'AC', 'LastName': 'Norlin', 'Affiliation': 'Department of Infectious Diseases, The Immunodeficiency Unit, Karolinska University Hospital Huddinge, SE-141 86 Stockholm, Sweden.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Hansen', 'Affiliation': 'Department of Infectious Diseases, The Immunodeficiency Unit, Karolinska University Hospital Huddinge, SE-141 86 Stockholm, Sweden.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Wahren Borgström', 'Affiliation': 'Department of Infectious Diseases, The Immunodeficiency Unit, Karolinska University Hospital Huddinge, SE-141 86 Stockholm, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bergman', 'Affiliation': 'Department of Infectious Diseases, The Immunodeficiency Unit, Karolinska University Hospital Huddinge, SE-141 86 Stockholm, Sweden.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Björkhem-Bergman', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society (NVS), Division of Clinical Geriatrics, Blickagången 16, Neo floor 7, SE-141 83 Huddinge, Sweden.'}]",Nutrients,['10.3390/nu12051230']
72,32361126,Kinetic parameters during land and water walking performed by individuals with Down Syndrome.,"BACKGROUND


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


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


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


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


Individuals with DS present reduced Fz outcomes during water walking in comparison to land. Therefore, water walking may be performed by individuals with DS with safe vertical loads on lower limbs regardless the self-selected speed for rehabilitation, correction of gait and training purposes.",2020,"In the aquatic environment, no significant difference was observed for the first and second Fz peaks with the increasing speed of walking.","['individuals with DS', 'individuals with Down Syndrome', 'Individuals with DS present', 'Fourteen adults with DS (age: 27.9\u2009±\u20097.9 years; body mass: 58.4\u2009±\u200912.9\u2009kg; height: 1.4\u2009±\u20090.1\u2009m, body mass index: 29.2\u2009±\u20095.4\u2009kg.m -2 ) completed two sessions of data collection, one on land and another in aquatic environment']",['vertical ground reaction force (Fz) of walking performed in water and on land'],"['speed of walking', 'second peak of Fz', 'reduced Fz outcomes', 'loading rate']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013080', 'cui_str': 'Trisomy 21'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0563034', 'cui_str': 'Aquatic environment'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0557668', 'cui_str': 'Landing'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",14.0,0.0231467,"In the aquatic environment, no significant difference was observed for the first and second Fz peaks with the increasing speed of walking.","[{'ForeName': 'Gabriela Neves', 'Initials': 'GN', 'LastName': 'Nunes', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Stephanie Santana', 'Initials': 'SS', 'LastName': 'Pinto', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Gabriele Randuz', 'Initials': 'GR', 'LastName': 'Krüger', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Leonardo Alexandre', 'Initials': 'LA', 'LastName': 'Peyré-Tartaruga', 'Affiliation': 'Exercise Research Laboratory, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Luana Siqueira', 'Initials': 'LS', 'LastName': 'Andrade', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Graciele Ferreira', 'Initials': 'GF', 'LastName': 'Mendes', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Vitor de Lima', 'Initials': 'VL', 'LastName': 'Krüger', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Rochele Barboza', 'Initials': 'RB', 'LastName': 'Pinheiro', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Alexandre Carriconde', 'Initials': 'AC', 'LastName': 'Marques', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Cristine Lima', 'Initials': 'CL', 'LastName': 'Alberton', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil. Electronic address: tinialberton@yahoo.com.br.'}]",Gait & posture,['10.1016/j.gaitpost.2020.04.017']
73,32369281,A Trial of Lopinavir-Ritonavir in Covid-19.,,2020,,['Covid-19'],['Lopinavir-Ritonavir'],[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}]",[],,0.0535202,,"[{'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Dalerba', 'Affiliation': 'Columbia University, New York, NY pdd2109@columbia.edu.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Levin', 'Affiliation': 'Columbia University, New York, NY pdd2109@columbia.edu.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Thompson', 'Affiliation': 'Columbia University, New York, NY pdd2109@columbia.edu.'}]",The New England journal of medicine,['10.1056/NEJMc2008043']
74,32369283,A Trial of Lopinavir-Ritonavir in Covid-19.,,2020,,['Covid-19'],['Lopinavir-Ritonavir'],[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}]",[],,0.0535202,,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Havlichek', 'Affiliation': 'Michigan State University, East Lansing, MI havliche@msu.edu.'}]",The New England journal of medicine,['10.1056/NEJMc2008043']
75,32369284,A Trial of Lopinavir-Ritonavir in Covid-19.,,2020,,['Covid-19'],['Lopinavir-Ritonavir'],[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}]",[],,0.0535202,,"[{'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Corrao', 'Affiliation': 'University of Palermo School of Medicine, Palermo, Italy s.corrao@tiscali.it.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Natoli', 'Affiliation': 'ARNAS Civico Di Cristina Benfratelli, Palermo, Italy.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Cacopardo', 'Affiliation': 'University of Catania School of Medicine, Catania, Italy.'}]",The New England journal of medicine,['10.1056/NEJMc2008043']
76,32369285,A Trial of Lopinavir-Ritonavir in Covid-19.,,2020,,['Covid-19'],['Lopinavir-Ritonavir'],[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}]",[],,0.0535202,,"[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Carmona-Bayonas', 'Affiliation': 'Hospital Universitario Morales Meseguer, Murcia, Spain alberto.carmonabayonas@gmail.com.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Jimenez-Fonseca', 'Affiliation': 'Hospital Universitario Central de Asturias, Oviedo, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Castañón', 'Affiliation': 'Clínica Universidad de Navarra, Madrid, Spain.'}]",The New England journal of medicine,['10.1056/NEJMc2008043']
77,32369282,A Trial of Lopinavir-Ritonavir in Covid-19.,,2020,,['Covid-19'],['Lopinavir-Ritonavir'],[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}]",[],,0.0535202,,"[{'ForeName': 'Kurt M', 'Initials': 'KM', 'LastName': 'Kunz', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA kkunz@sas.upenn.edu.'}]",The New England journal of medicine,['10.1056/NEJMc2008043']
78,32365533,The Effect of a Virtual Reality-Based Intervention Program on Cognition in Older Adults with Mild Cognitive Impairment: A Randomized Control Trial.,"This study aimed to investigate the association between a virtual reality (VR) intervention program and cognitive, brain and physical functions in high-risk older adults. In a randomized controlled trial, we enrolled 68 individuals with mild cognitive impairment (MCI). The MCI diagnosis was based on medical evaluations through a clinical interview conducted by a dementia specialist. Cognitive assessments were performed by neuropsychologists according to standardized methods, including the Mini-Mental State Examination (MMSE) and frontal cognitive function: trail making test (TMT) A & B, and symbol digit substitute test (SDST). Resting state electroencephalogram (EEG) was measured in eyes open and eyes closed conditions for 5 minutes each, with a 19-channel wireless EEG device. The VR intervention program (3 times/week, 100 min each session) comprised four types of VR game-based content to improve the attention, memory and processing speed. Analysis of the subjects for group-time interactions revealed that the intervention group exhibited a significantly improved executive function and brain function at the resting state. Additionally, gait speed and mobility were also significantly improved between and after the follow-up. The VR-based training program improved cognitive and physical function in patients with MCI relative to controls. Encouraging patients to perform VR and game-based training may be beneficial to prevent cognitive decline.",2020,Analysis of the subjects for group-time interactions revealed that the intervention group exhibited a significantly improved executive function and brain function at the resting state.,"['high-risk older adults', 'patients with MCI relative to controls', '68 individuals with mild cognitive impairment (MCI', 'Older Adults with Mild Cognitive Impairment']","['symbol digit substitute test (SDST', '19-channel wireless EEG device', 'VR-based training program', 'Virtual Reality-Based Intervention Program', 'virtual reality (VR) intervention program and cognitive, brain and physical functions']","['Resting state electroencephalogram (EEG', 'gait speed and mobility', 'cognitive and physical function', 'Mini-Mental State Examination (MMSE) and frontal cognitive function: trail making test (TMT', 'executive function and brain function']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}]","[{'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0040604', 'cui_str': 'Trail making test'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}]",68.0,0.0141577,Analysis of the subjects for group-time interactions revealed that the intervention group exhibited a significantly improved executive function and brain function at the resting state.,"[{'ForeName': 'Ngeemasara', 'Initials': 'N', 'LastName': 'Thapa', 'Affiliation': 'Department of Health Sciences, Graduate School, Dong-A University, Busan 49315, Korea.'}, {'ForeName': 'Hye Jin', 'Initials': 'HJ', 'LastName': 'Park', 'Affiliation': 'Department of Health Sciences, Graduate School, Dong-A University, Busan 49315, Korea.'}, {'ForeName': 'Ja-Gyeong', 'Initials': 'JG', 'LastName': 'Yang', 'Affiliation': 'Department of Health Sciences, Graduate School, Dong-A University, Busan 49315, Korea.'}, {'ForeName': 'Haeun', 'Initials': 'H', 'LastName': 'Son', 'Affiliation': 'Department of Health Sciences, Graduate School, Dong-A University, Busan 49315, Korea.'}, {'ForeName': 'Minwoo', 'Initials': 'M', 'LastName': 'Jang', 'Affiliation': 'Department of Health Sciences, Graduate School, Dong-A University, Busan 49315, Korea.'}, {'ForeName': 'Jihyeon', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Health Sciences, Graduate School, Dong-A University, Busan 49315, Korea.'}, {'ForeName': 'Seung Wan', 'Initials': 'SW', 'LastName': 'Kang', 'Affiliation': 'Data Center for Korean EEG, College of Nursing, Seoul National University, Seoul 03080, Korea.'}, {'ForeName': 'Kyung Won', 'Initials': 'KW', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Dong-A University College of Medicine, Busan 49201, Korea.'}, {'ForeName': 'Hyuntae', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Department of Health Sciences, Graduate School, Dong-A University, Busan 49315, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9051283']
79,32365359,"Rifabutin-Based Triple Therapy (RHB-105) for  Helicobacter pylori  Eradication: A Double-Blind, Randomized, Controlled Trial.","BACKGROUND


Although consensus supports eradication of  Helicobacter pylori  infections, antimicrobial resistance has substantially reduced eradication rates with most current therapies.
OBJECTIVE


To assess the effectiveness of a novel rifabutin-based therapy (RHB-105) for  H pylori  eradication.
DESIGN


Phase 3, double-blind trial (ERADICATE Hp2). (ClinicalTrials.gov: NCT03198507).
SETTING


55 clinical research sites in the United States.
PARTICIPANTS


455 treatment-naive adults with epigastric discomfort and confirmed  H pylori  infection.
INTERVENTION


RHB-105 (amoxicillin, 3 g; omeprazole, 120 mg; and rifabutin, 150 mg) versus active comparator (amoxicillin, 3 g, and omeprazole, 120 mg), given as 4 capsules every 8 hours for 14 days.
MEASUREMENTS


Between-group difference for  H pylori  eradication rate, demonstrated by  13 C urea breath test 4 weeks after treatment, analyzed by using the χ 2  test.
RESULTS


In the intention-to-treat population, the eradication rate was higher with RHB-105 than with the active comparator (228 vs. 227 patients, respectively; 83.8% [95% CI, 78.4% to 88.0%] vs. 57.7% [95% CI, 51.2% to 64.0%];  P  < 0.001). Eradication rates were unaffected by resistance to clarithromycin or metronidazole. No rifabutin resistance was detected. The most commonly reported adverse events (incidence ≥5%) were diarrhea (10.1% with RHB-105 vs. 7.9% with active comparator), headache (7.5% vs. 7.0%), and nausea (4.8% vs. 5.3%).
LIMITATION


Persons of Asian descent were excluded because of their higher prevalence of poor cytochrome P450 2C19 metabolizers.
CONCLUSION


These findings suggest potential for RHB-105 as first-line empirical  H pylori  therapy, addressing an unmet need in the current environment of increasing antibiotic resistance.
PRIMARY FUNDING SOURCE


RedHill Biopharma Ltd.",2020,Eradication rates were unaffected by resistance to clarithromycin or metronidazole.,"['Participants\n\n\n455 treatment-naive adults with epigastric discomfort and confirmed H pylori infection', 'Helicobacter pylori Eradication', 'Limitation\n\n\nPersons of Asian descent']","['novel rifabutin-based therapy (RHB-105', 'RHB-105 (amoxicillin, 3 g; omeprazole, 120 mg; and rifabutin, 150 mg) versus active comparator (amoxicillin, 3 g, and omeprazole', 'Rifabutin-Based Triple Therapy (RHB-105', 'metronidazole', 'clarithromycin']","['headache', 'diarrhea', 'rifabutin resistance', 'eradication rate', 'Eradication rates', 'adverse events', 'nausea', 'eradication rates', 'H pylori eradication rate']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0232570', 'cui_str': 'Epigastric fullness'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0205386', 'cui_str': 'Descending'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0140575', 'cui_str': 'Rifabutin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0140575', 'cui_str': 'Rifabutin'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}]",455.0,0.422929,Eradication rates were unaffected by resistance to clarithromycin or metronidazole.,"[{'ForeName': 'David Y', 'Initials': 'DY', 'LastName': 'Graham', 'Affiliation': 'Baylor College of Medicine, Houston, Texas (D.Y.G., K.G.H.).'}, {'ForeName': 'Yamil', 'Initials': 'Y', 'LastName': 'Canaan', 'Affiliation': 'Jesscan Medical Research, Miami, Florida (Y.C.).'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Maher', 'Affiliation': 'BI Research Center, Houston, Texas (J.M.).'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Wiener', 'Affiliation': 'GW Research, Inc., Chula Vista, California (G.W.).'}, {'ForeName': 'Kristina G', 'Initials': 'KG', 'LastName': 'Hulten', 'Affiliation': 'Baylor College of Medicine, Houston, Texas (D.Y.G., K.G.H.).'}, {'ForeName': 'Ira N', 'Initials': 'IN', 'LastName': 'Kalfus', 'Affiliation': 'Independent Consultant to Pharmaceutical companies, New York, New York (I.N.K.).'}]",Annals of internal medicine,['10.7326/M19-3734']
80,32365675,"Correction: Sartorius et al. ""Postprandial Effects of a Proprietary Milk Protein Hydrolysate Containing Bioactive Peptides in Prediabetic Subjects""  Nutrients  2019 , 11,  1700.","Milk proteins have been hypothesized to protect against type 2 diabetes (T2DM) by beneficially modulating glycemic response, predominantly in the postprandial status. This potential is, amongst others, attributed to the high content of whey proteins, which are commonly a product of cheese production. However, native whey has received substantial attention due to its higher leucine content, and its postprandial glycemic effect has not been assessed thus far in prediabetes. In the present study, the impact of a milk protein hydrolysate of native whey origin with alpha-glucosidase inhibiting properties was determined in prediabetics in a randomized, cross-over trial. Subjects received a single dose of placebo or low- or high-dosed milk protein hydrolysate prior to a challenge meal high in carbohydrates. Concentration-time curves of glucose and insulin were assessed. Incremental areas under the curve (iAUC) of glucose as the primary outcome were significantly reduced by low-dosed milk peptides compared to placebo (p = 0.0472), and a minor insulinotropic effect was seen. A longer intervention period with the low-dosed product did not strengthen glucose response but significantly reduced HbA1c values (p = 0.0244). In conclusion, the current milk protein hydrolysate of native whey origin has the potential to modulate postprandial hyperglycemia and hence may contribute in reducing the future risk of developing T2DM.",2020,A longer intervention period with the low-dosed product did not strengthen glucose response but significantly reduced HbA1c values (p = 0.0244).,"['Prediabetic Subjects""  Nutrients  2019 , 11,  1700']","['placebo', 'milk protein hydrolysate', 'placebo or low- or high-dosed milk protein hydrolysate', 'Proprietary Milk Protein Hydrolysate Containing Bioactive Peptides']","['glucose response', 'Incremental areas under the curve (iAUC) of glucose', 'Concentration-time curves of glucose and insulin', 'insulinotropic effect']","[{'cui': 'C0678695', 'cui_str': 'Nutrients'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026138', 'cui_str': 'Milk protein'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0172105,A longer intervention period with the low-dosed product did not strengthen glucose response but significantly reduced HbA1c values (p = 0.0244).,"[{'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Sartorius', 'Affiliation': 'BioTeSys GmbH, Schelztorstr. 54-56, 73728 Esslingen, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Weidner', 'Affiliation': 'BioTeSys GmbH, Schelztorstr. 54-56, 73728 Esslingen, Germany.'}, {'ForeName': 'Tanita', 'Initials': 'T', 'LastName': 'Dharsono', 'Affiliation': 'BioTeSys GmbH, Schelztorstr. 54-56, 73728 Esslingen, Germany.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Boulier', 'Affiliation': 'Ingredia S.A., 51 Avenue F. Lobbedez CS 60946, 62033 Arras CEDEX, France.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Wilhelm', 'Affiliation': 'Department of Mathematics, Natural and Economic Sciences, Ulm University of Applied Sciences, Albert-Einstein-Allee 55, 89081 Ulm, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Schön', 'Affiliation': 'BioTeSys GmbH, Schelztorstr. 54-56, 73728 Esslingen, Germany.'}]",Nutrients,['10.3390/nu12051266']
81,32365853,Effects of Mini-Basketball Training Program on Executive Functions and Core Symptoms among Preschool Children with Autism Spectrum Disorders.,"This study examined the effects of a 12-week mini-basketball training program (MBTP) on executive functions and core symptoms among preschoolers with autism spectrum disorder (ASD). In this quasi-experimental pilot study, 33 ASD preschoolers who received their conventional rehabilitation program were assigned to either a MBTP group ( n  = 18) or control group ( n  = 15). Specifically, the experimental group was required to take an additional 12-week MBTP (five days per week, one session per day, and forty minutes per session), while the control group was instructed to maintain their daily activities. Executive functions and core symptoms (social communication impairment and repetitive behavior) were evaluated by the Childhood Executive Functioning Inventory (CHEXI), the Social Responsiveness Scale-Second Edition (SRS-2), and the Repetitive Behavior Scale-Revised (RBS-R), respectively. After the 12-week intervention period, the MBTP group exhibited significantly better performances in working memory ( F  = 7.51,  p  < 0.01, partial  η 2  = 0.195) and regulation ( F  = 4.23,  p  < 0.05, partial  η 2  = 0.12) as compared to the control group. Moreover, the MBTP significantly improved core symptoms of ASD preschoolers, including the social communication impairment ( F  = 6.02,  p  < 0.05, partial  η 2  = 0.020) and repetitive behavior ( F  = 5.79,  p  < 0.05, partial  η 2  = 0.016). Based on our findings, we concluded that the 12-week MBTP may improve executive functions and core symptoms in preschoolers with ASD, and we provide new evidence that regular physical exercise in the form of a MBTP is a promising alternative to treat ASD.",2020,"After the 12-week intervention period, the MBTP group exhibited significantly better performances in working memory ( F  = 7.51,  p  < 0.01, partial  η 2  = 0.195) and regulation ( F  = 4.23,  p  < 0.05, partial  η 2  = 0.12) as compared to the control group.","['preschoolers with autism spectrum disorder (ASD', 'Preschool Children with Autism Spectrum Disorders', '33 ASD preschoolers who received their', 'preschoolers with ASD']","['Mini-Basketball Training Program', 'mini-basketball training program (MBTP', 'conventional rehabilitation program', 'MBTP']","['performances in working memory', 'executive functions', 'Executive functions and core symptoms (social communication impairment and repetitive behavior', 'Executive Functions and Core Symptoms', 'Childhood Executive Functioning Inventory (CHEXI), the Social Responsiveness Scale-Second Edition (SRS-2), and the Repetitive Behavior Scale-Revised (RBS-R', 'social communication impairment', 'repetitive behavior', 'executive functions and core symptoms']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}]","[{'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009460', 'cui_str': 'Communication disorder'}, {'cui': 'C1827547', 'cui_str': 'Repetitious behavior'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441795', 'cui_str': 'Second edition'}, {'cui': 'C0175693', 'cui_str': 'Russell-Silver syndrome'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}]",33.0,0.0130992,"After the 12-week intervention period, the MBTP group exhibited significantly better performances in working memory ( F  = 7.51,  p  < 0.01, partial  η 2  = 0.195) and regulation ( F  = 4.23,  p  < 0.05, partial  η 2  = 0.12) as compared to the control group.","[{'ForeName': 'Jin-Gui', 'Initials': 'JG', 'LastName': 'Wang', 'Affiliation': 'College of Physical Education, Yangzhou University, Yangzhou 225127, China.'}, {'ForeName': 'Ke-Long', 'Initials': 'KL', 'LastName': 'Cai', 'Affiliation': 'College of Physical Education, Yangzhou University, Yangzhou 225127, China.'}, {'ForeName': 'Zhi-Mei', 'Initials': 'ZM', 'LastName': 'Liu', 'Affiliation': 'College of Physical Education, Yangzhou University, Yangzhou 225127, China.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Herold', 'Affiliation': 'Research Group Neuroprotection, German Center for Neurodegenerative Diseases (DZNE), Leipziger Str. 44, 39120 Magdeburg, Germany.'}, {'ForeName': 'Liye', 'Initials': 'L', 'LastName': 'Zou', 'Affiliation': 'Exercise and Mental Health Laboratory, School of Psychology, Shenzhen University, Shenzhen 518060, China.'}, {'ForeName': 'Li-Na', 'Initials': 'LN', 'LastName': 'Zhu', 'Affiliation': 'School of Physical Education and Sports Science, Beijing Normal University, Beijing 100000, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Xiong', 'Affiliation': 'College of Physical Education, Yangzhou University, Yangzhou 225127, China.'}, {'ForeName': 'Ai-Guo', 'Initials': 'AG', 'LastName': 'Chen', 'Affiliation': 'College of Physical Education, Yangzhou University, Yangzhou 225127, China.'}]",Brain sciences,['10.3390/brainsci10050263']
82,32365979,"CUL4A ,  ERCC5 , and  ERCC1  as Predictive Factors for Trabectedin Efficacy in Advanced Soft Tissue Sarcomas (STS): A Spanish Group for Sarcoma Research (GEIS) Study.","A translational study was designed to analyze the expression of nucleotide excision repair (NER) and homologous recombination (HR) genes as potential predictive biomarkers for trabectedin in soft-tissue sarcoma (STS). This study is part of a randomized phase II trial comparing trabectedin plus doxorubicin versus doxorubicin in advanced STS. Gene expression levels were evaluated by qRT-PCR, while CUL4A protein levels were quantified by immunohistochemistry. Expression levels were correlated with patients' progression-free survival (PFS) and overall survival (OS). Gene expression was also evaluated in cell lines and correlated with trabectedin sensitivity. In doxorubicin arm and in the whole series, which includes samples from both arms, no significant differences in terms of PFS were observed amongst the analyzed genes. In the group treated with trabectedin plus doxorubicin, the median of PFS was significantly longer in cases with  CUL4A ,  ERCC1,  or  ERCC5  overexpression, while  BRCA1  expression did not correlated with PFS. Gene expression had no prognostic influence in OS. CUL4A protein levels correlated with worse PFS in doxorubicin arm and in the whole series. In cell lines, only overexpression of  ERCC1  was significantly correlated with trabectedin sensitivity. In conclusion,  CUL4A, ERCC5,  and mainly  ERCC1  acted as predictive factors for trabectedin efficacy in advanced STS.",2020,"In doxorubicin arm and in the whole series, which includes samples from both arms, no significant differences in terms of PFS were observed amongst the analyzed genes.","['advanced STS', 'soft-tissue sarcoma (STS', 'Advanced Soft Tissue Sarcomas (STS']","['trabectedin plus doxorubicin', 'trabectedin plus doxorubicin versus doxorubicin', 'nucleotide excision repair (NER) and homologous recombination (HR) genes', 'doxorubicin']","['CUL4A protein levels', 'progression-free survival (PFS) and overall survival (OS', 'PFS', 'Expression levels', 'median of PFS', 'Gene expression levels', 'qRT-PCR, while CUL4A protein levels', 'trabectedin sensitivity', 'Gene expression', 'overexpression of']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma'}]","[{'cui': 'C1311070', 'cui_str': 'trabectedin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0524550', 'cui_str': 'Nucleotide Excision Repair'}, {'cui': 'C0599773', 'cui_str': 'Homologous Recombination'}, {'cui': 'C0017337', 'cui_str': 'Gene'}]","[{'cui': 'C0428479', 'cui_str': 'Protein level - finding'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C1311070', 'cui_str': 'trabectedin'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.0252561,"In doxorubicin arm and in the whole series, which includes samples from both arms, no significant differences in terms of PFS were observed amongst the analyzed genes.","[{'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Moura', 'Affiliation': 'Institute of Biomedicine of Sevilla (IBIS, HUVR, CSIC, Universidad de Sevilla), 41013 Sevilla, Spain.'}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'Sanchez-Bustos', 'Affiliation': 'Institute of Biomedicine of Sevilla (IBIS, HUVR, CSIC, Universidad de Sevilla), 41013 Sevilla, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Fernandez-Serra', 'Affiliation': 'Laboratory of Molecular Biology, Fundación Instituto Valenciano de Oncología, 46009 Valencia, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Lopez-Alvarez', 'Affiliation': 'Institute of Biomedicine of Sevilla (IBIS, HUVR, CSIC, Universidad de Sevilla), 41013 Sevilla, Spain.'}, {'ForeName': 'José L', 'Initials': 'JL', 'LastName': 'Mondaza-Hernandez', 'Affiliation': 'Institute of Biomedicine of Sevilla (IBIS, HUVR, CSIC, Universidad de Sevilla), 41013 Sevilla, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Blanco-Alcaina', 'Affiliation': 'Institute of Biomedicine of Sevilla (IBIS, HUVR, CSIC, Universidad de Sevilla), 41013 Sevilla, Spain.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Gavilan-Naranjo', 'Affiliation': 'Institute of Biomedicine of Sevilla (IBIS, HUVR, CSIC, Universidad de Sevilla), 41013 Sevilla, Spain.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Martinez-Delgado', 'Affiliation': 'Institute of Biomedicine of Sevilla (IBIS, HUVR, CSIC, Universidad de Sevilla), 41013 Sevilla, Spain.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Lacerenza', 'Affiliation': 'Institute of Biomedicine of Sevilla (IBIS, HUVR, CSIC, Universidad de Sevilla), 41013 Sevilla, Spain.'}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'Santos-Fernandez', 'Affiliation': 'Institute of Biomedicine of Sevilla (IBIS, HUVR, CSIC, Universidad de Sevilla), 41013 Sevilla, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Carrasco-Garcia', 'Affiliation': 'Institute of Biomedicine of Sevilla (IBIS, HUVR, CSIC, Universidad de Sevilla), 41013 Sevilla, Spain.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Hidalgo-Rios', 'Affiliation': 'Institute of Biomedicine of Sevilla (IBIS, HUVR, CSIC, Universidad de Sevilla), 41013 Sevilla, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gutierrez', 'Affiliation': 'Hematology Department, University Hospital Son Espases/IdISBa, 07120 Mallorca, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Ramos', 'Affiliation': 'Pathology Department, University Hospital Son Espases, 07120 Mallorca, Spain.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Hindi', 'Affiliation': 'Institute of Biomedicine of Sevilla (IBIS, HUVR, CSIC, Universidad de Sevilla), 41013 Sevilla, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Taron', 'Affiliation': 'Institute of Biomedicine of Sevilla (IBIS, HUVR, CSIC, Universidad de Sevilla), 41013 Sevilla, Spain.'}, {'ForeName': 'Jose Antonio', 'Initials': 'JA', 'LastName': 'Lopez-Guerrero', 'Affiliation': 'Laboratory of Molecular Biology, Fundación Instituto Valenciano de Oncología, 46009 Valencia, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Martin-Broto', 'Affiliation': 'Institute of Biomedicine of Sevilla (IBIS, HUVR, CSIC, Universidad de Sevilla), 41013 Sevilla, Spain.'}]",Cancers,['10.3390/cancers12051128']
83,32360399,Effect of different exercise training intensities on musculoskeletal and neuropathic pain in inactive individuals with type 2 diabetes - Preliminary randomised controlled trial.,"AIMS


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


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


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


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


ACTRN12615000475549.",2020,"Compared to CON, reduction in musculoskeletal pain intensity was significantly greater for C-HIIT (MD -5.4, 95% CI [","['inactive individuals with type 2 diabetes', 'Thirty-two inactive adults with T2D (59% male, mean age 58.7±9.1yrs, median HbA 1c  7.8', 'People with type 2 diabetes (T2D', 'Inactive Individuals with Type 2 Diabetes']","['usual care (CON), supervised combined aerobic and resistance moderate-intensity continuous training (C-MICT), or supervised combined high-intensity interval training (C-HIIT', 'CON', 'Different Exercise Training Intensities']","['modified Nordic Musculoskeletal Questionnaire and the Neuropathy Total Symptom Score-6 respectively', 'sensory function', 'Adverse events', 'Musculoskeletal and Neuropathic Pain', 'musculoskeletal pain intensity', 'neuropathy symptoms', 'adverse events', 'pain pressure thresholds', 'musculoskeletal and neuropathic pain', 'musculoskeletal pain']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",32.0,0.143575,"Compared to CON, reduction in musculoskeletal pain intensity was significantly greater for C-HIIT (MD -5.4, 95% CI [","[{'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Cox', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Trishan', 'Initials': 'T', 'LastName': 'Gajanand', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Nicola W', 'Initials': 'NW', 'LastName': 'Burton', 'Affiliation': 'School of Applied Psychology, Griffith University, Mt Gravatt, Queensland, Australia.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Coombes', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Brooke K', 'Initials': 'BK', 'LastName': 'Coombes', 'Affiliation': 'School of Allied Health Sciences, Griffith University, Nathan, Queensland, Australia. Electronic address: b.coombes@griffith.edu.au.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108168']
84,32365981,The Effect of  Lactobacillus plantarum  299v on Iron Status and Physical Performance in Female Iron-Deficient Athletes: A Randomized Controlled Trial.,"Iron is an essential micronutrient for oxygen transport and mitochondrial metabolism and is critical for physical performance. Compromised iron stores are more commonly found among athletes, and females are especially at risk. Iron deficiency is generally treated using oral iron supplements. However, only a small proportion of ingested iron is absorbed, necessitating higher intakes, which may result in adverse side effects, reduced compliance, and inefficient repletion of iron stores. The probiotic strain  Lactobacillus plantarum  299v (Lp299v) significantly increases intestinal iron absorption in meal studies. The present study was conducted to explore the effects of 20 mg of iron with or without Lp299v on iron status, mood state, and physical performance. Fifty-three healthy non-anemic female athletes with low iron stores (ferritin < 30 μg/L) were randomized, and 39 completed the study. Intake of Lp299v with iron for four weeks increased ferritin levels more than iron alone (13.6 vs. 8.2 µg/L), but the difference between the groups was not significant ( p  = 0.056). The mean reticulocyte hemoglobin content increased after intake of Lp299v compared to control (1.5 vs. 0.82 pg) after 12 weeks, but the difference between the group was not significant ( p  = 0.083). The Profile of Mood States (POMS) questionnaire showed increased vigor with Lp299v vs. iron alone after 12 weeks (3.5 vs. 0.1,  p  = 0.015). No conclusive effects on physical performance were observed. In conclusion, Lp299v, together with 20 mg of iron, could result in a more substantial and rapid improvement in iron status and improved vigor compared to 20 mg of iron alone. A larger clinical trial is needed to further explore these findings as well as the impact of Lp299v on physical performance.",2020,Intake of Lp299v with iron for four weeks increased ferritin levels more than iron alone,"['Fifty-three healthy non-anemic female athletes with low iron stores (ferritin < 30 μg/L', 'Female Iron-Deficient Athletes']","['20 mg of iron with or without Lp299v', 'iron alone', 'Lactobacillus plantarum  299v', 'probiotic strain  Lactobacillus plantarum  299v (Lp299v']","['Profile of Mood States (POMS) questionnaire', 'iron status, mood state, and physical performance', 'mean reticulocyte hemoglobin content', 'Iron Status and Physical Performance', 'intestinal iron absorption', 'physical performance', 'ferritin levels', 'iron status and improved vigor']","[{'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0860975', 'cui_str': 'Iron low'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}]","[{'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}]","[{'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0035286', 'cui_str': 'Reticulocyte'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",53.0,0.0766623,Intake of Lp299v with iron for four weeks increased ferritin levels more than iron alone,"[{'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Axling', 'Affiliation': 'Probi AB, 223 70 Lund, Sweden.'}, {'ForeName': 'Gunilla', 'Initials': 'G', 'LastName': 'Önning', 'Affiliation': 'Probi AB, 223 70 Lund, Sweden.'}, {'ForeName': 'Maile A', 'Initials': 'MA', 'LastName': 'Combs', 'Affiliation': ""Nutrition and Scientific Affairs Department, The Nature's Bounty Co., Ronkonkoma, NY 11779, USA.""}, {'ForeName': 'Alemtsehay', 'Initials': 'A', 'LastName': 'Bogale', 'Affiliation': ""Nutrition and Scientific Affairs Department, The Nature's Bounty Co., Ronkonkoma, NY 11779, USA.""}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Högström', 'Affiliation': 'Sports Medicine Umeå AB and Orthopedics, Department of Surgical and Perioperative Sciences, Umeå University, 901 87 Umeå, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Svensson', 'Affiliation': 'Section of Sports Medicine, Department of Community Medicine and Rehabilitation, Umeå University, 901 87 Umeå, Sweden.'}]",Nutrients,['10.3390/nu12051279']
85,32366578,Cardiovascular Risk Reduction With Liraglutide: An Exploratory Mediation Analysis of the LEADER Trial.,"OBJECTIVE


The Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) trial (ClinicalTrials.gov reg. no. NCT01179048) demonstrated a reduced risk of cardiovascular (CV) events for patients with type 2 diabetes who received the glucagon-like peptide 1 receptor agonist liraglutide versus placebo. The mechanisms behind this CV benefit remain unclear. We aimed to identify potential mediators for the CV benefit observed with liraglutide in the LEADER trial.
RESEARCH DESIGN AND METHODS


We performed exploratory analyses to identify potential mediators of the effect of liraglutide on major adverse CV events (MACE; composite of CV death, nonfatal myocardial infarction, or nonfatal stroke) from the following candidates: glycated hemoglobin (HbA 1c ), body weight, urinary albumin-to-creatinine ratio (UACR), confirmed hypoglycemia, sulfonylurea use, insulin use, systolic blood pressure, and LDL cholesterol. These candidates were selected as CV risk factors on which liraglutide had an effect in LEADER such that a reduction in CV risk might result. We used two methods based on a Cox proportional hazards model and the new Vansteelandt method designed to use all available information from the mediator and to control for confounding factors.
RESULTS


Analyses using the Cox methods and Vansteelandt method indicated potential mediation by HbA 1c  (up to 41% and 83% mediation, respectively) and UACR (up to 29% and 33% mediation, respectively) on the effect of liraglutide on MACE. Mediation effects were small for other candidates.
CONCLUSIONS


These analyses identify HbA 1c  and, to a lesser extent, UACR as potential mediators of the CV effects of liraglutide. Whether either is a marker of an unmeasured factor or a true mediator remains a key question that invites further investigation.",2020,"Mediation effects were small for other candidates.
",['patients with type 2 diabetes who received the'],"['liraglutide', 'glucagon-like peptide 1 receptor agonist liraglutide versus placebo', 'Liraglutide']","['UACR', 'potential mediation by HbA 1c', 'risk of cardiovascular (CV) events', 'glycated hemoglobin (HbA 1c ), body weight, urinary albumin-to-creatinine ratio (UACR), confirmed hypoglycemia, sulfonylurea use, insulin use, systolic blood pressure, and LDL cholesterol', 'major adverse CV events (MACE; composite of CV death, nonfatal myocardial infarction, or nonfatal stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0680727', 'cui_str': 'Mediation'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0240016', 'cui_str': 'Insulin used'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",,0.0770687,"Mediation effects were small for other candidates.
","[{'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill, NC jbuse@med.unc.edu.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Bain', 'Affiliation': 'Swansea University Medical School, Swansea, U.K.'}, {'ForeName': 'Johannes F E', 'Initials': 'JFE', 'LastName': 'Mann', 'Affiliation': 'KfH Kidney Centre, Munich, Germany.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nauck', 'Affiliation': 'Diabetes Center Bochum-Hattingen, St. Josef Hospital (Ruhr-Universität Bochum), Bochum, Germany.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Nissen', 'Affiliation': 'Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Pocock', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, U.K.'}, {'ForeName': 'Neil R', 'Initials': 'NR', 'LastName': 'Poulter', 'Affiliation': 'School of Public Health, Imperial College London, London, U.K.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Pratley', 'Affiliation': 'AdventHealth Translational Research Institute, Orlando, FL.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Linder', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Tea', 'Initials': 'T', 'LastName': 'Monk Fries', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Ørsted', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-2251']
86,32363411,Building Emotional Resilience in Youth in Lebanon: a School-Based Randomized Controlled Trial of the FRIENDS Intervention.,"In Lebanon, approximately one in four adolescents suffers from a psychiatric disorder. Alarmingly, 94% of adolescents with a mental disorder have not sought any treatment. This study assessed the effectiveness of an evidence-based school-based universal mental health intervention (the FRIENDS program) in reducing depression and anxiety symptoms in middle school students in Lebanon. A total of 280 6th graders aged 11-13 years were recruited from 10 schools in Beirut. Schools were matched on size and tuition and randomly assigned to intervention or control groups. The FRIENDS program was translated into Arabic, adapted, and then implemented by trained mental health professionals during 10 classroom sessions over 3 months. We assessed sociodemographic and relevant psychological symptoms by self-report, using the Scale for Childhood Anxiety and Related Disorders (SCARED), Mood and Feelings Questionnaire (MFQ), and Strengths and Difficulties Questionnaire (SDQ), at baseline. We re-administered these scales at 3 months post-intervention. There was a significant time × group interaction for the SDQ emotional score (p = 0.011) and total MFQ score (p = 0.039) indicating significant improvement in depressive and emotional symptoms in the intervention group. Subgroup analysis by gender showed a significant time × group interaction for the total SCARED score (p = 0.025) in females but not in males (p = 0.137), consistent with a reduction of anxiety symptoms in this stratum of the intervention group as compared with the control group. The FRIENDS program was effective in reducing general emotional and depressive symptoms among middle school students in this Lebanese study population. This intervention provides an opportunity for promoting mental health in Lebanese schools and reducing the treatment gap in mental health care.",2020,"Subgroup analysis by gender showed a significant time × group interaction for the total SCARED score (p = 0.025) in females but not in males (p = 0.137), consistent with a reduction of anxiety symptoms in this stratum of the intervention group as compared with the control group.","['A total of 280 6th graders aged 11-13\xa0years were recruited from 10 schools in Beirut', 'Youth in Lebanon', 'adolescents with a mental disorder', 'middle school students in Lebanon', 'middle school students in this Lebanese study population']",['evidence-based school-based universal mental health intervention (the FRIENDS program'],"['Childhood Anxiety and Related Disorders (SCARED), Mood and Feelings Questionnaire (MFQ), and Strengths and Difficulties Questionnaire (SDQ', 'Building Emotional Resilience', 'anxiety symptoms', 'total SCARED score', 'depressive and emotional symptoms', 'general emotional and depressive symptoms', 'depression and anxiety symptoms', 'SDQ emotional score', 'total MFQ score']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0023190', 'cui_str': 'Lebanon'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",280.0,0.0621785,"Subgroup analysis by gender showed a significant time × group interaction for the total SCARED score (p = 0.025) in females but not in males (p = 0.137), consistent with a reduction of anxiety symptoms in this stratum of the intervention group as compared with the control group.","[{'ForeName': 'Fadi T', 'Initials': 'FT', 'LastName': 'Maalouf', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, American University of Beirut, P.O. Box 11-0236, Riad El-Solh/Beirut, 1107 2020, Lebanon. fm38@aub.edu.lb.'}, {'ForeName': 'Loay', 'Initials': 'L', 'LastName': 'Alrojolah', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, American University of Beirut, P.O. Box 11-0236, Riad El-Solh/Beirut, 1107 2020, Lebanon.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Ghandour', 'Affiliation': 'Department of Epidemiology and Population, Faculty of Health Sciences, American University of Beirut, P.O. Box 11-0236, Riad El-Solh/Beirut, 1107 2020, Lebanon. lg01@aub.edu.lb.'}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Afifi', 'Affiliation': 'Community and Behavioral, College of Public Health, University of Iowa, Iowa, IA, USA.'}, {'ForeName': 'Leyla Akoury', 'Initials': 'LA', 'LastName': 'Dirani', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, American University of Beirut, P.O. Box 11-0236, Riad El-Solh/Beirut, 1107 2020, Lebanon.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Barrett', 'Affiliation': 'Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Nakkash', 'Affiliation': 'Department of Health Promotion and Community Health, Faculty of Health Sciences, American University of Beirut, Beirut, Lebanon.'}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Shamseddeen', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, American University of Beirut, P.O. Box 11-0236, Riad El-Solh/Beirut, 1107 2020, Lebanon.'}, {'ForeName': 'Farah', 'Initials': 'F', 'LastName': 'Tabaja', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, American University of Beirut, P.O. Box 11-0236, Riad El-Solh/Beirut, 1107 2020, Lebanon.'}, {'ForeName': 'Courtney M', 'Initials': 'CM', 'LastName': 'Yuen', 'Affiliation': 'Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Becker', 'Affiliation': 'Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01123-5']
87,32360848,"Bond assessment of resin modified glass ionomer cement to dentin conditioned with photosensitizers, laser and conventional regimes.","AIM


To assess different conditioning regimes on shear bond strength (SBS) of resin modified glass ionomer cement (RMGIC) bonded to dentin MATERIAL AND METHODS: Fifty non carious intact maxillary molars were cleaned, isolated and randomly divided into five groups (n = 10). Before randomization, dentin surface was exposed and finished. Samples in group 1 were conditioned with methylene blue photosensitizer (MBP) 50 mg/l and activated by photodynamic therapy (PDT), Group 2: surface treated with Er,Cr:YSGG (ECL), Group 3: surface conditioned with polyacrylic acid (PAA) (control), Group 4: surface conditioned with 17 % Ethylenediaminetetraacetic acid (EDTA), Group 5: surface conditioned with total etch (Optibond solo Plus). For SBS testing the samples were placed in universal testing machine. Fracture analysis of debonded surfaces were evaluated using stereomicroscope at 40x magnification. Means and standard deviations were calculated using analysis of variance (ANOVA) and Tukey's post hoc test at a significance level of (p < 0.05).
RESULTS


The maximum bond strength was found in group 5 conditioned with Optibond solo plus total etch (23.15 ± 3.21 MPa). Whereas, the lowest bond values were observed in group 1 treated with MBP (15.25 ± 1.54 MPa). Moreover, samples in group 2, group 3 and group 4 resulted in comparable bond strength (p > 0.05).
CONCLUSION


MBP at 50 mg/l is not recommended to condition dentin prior to RMGIC application. Moreover, ECL has a potential to be suggested for dentin conditioning compared to PAA.",2020,"Moreover, samples in group 2, group 3 and group 4 resulted in comparable bond strength (p > 0.05) CONCLUSION: MBP at 50 mg/",['Fifty non carious intact maxillary molars'],"['photodynamic therapy (PDT), Group 2: surface treated with Er,Cr:YSGG (ECL), Group 3: surface conditioned with polyacrylic acid (PAA) (control), Group 4: surface conditioned with 17% Ethylenediaminetetraacetic acid (EDTA), Group 5: surface conditioned with total etch (Optibond solo Plus', 'ECL', 'methylene blue photosensitizer (MBP) 50', 'MBP']","['maximum bond strength', 'shear bond strength (SBS', 'lowest bond values', 'bond strength']","[{'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0054720', 'cui_str': 'Carbomer-940'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0013618', 'cui_str': 'Edetic Acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1121655', 'cui_str': 'OptiBond Solo Plus'}, {'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C0162713', 'cui_str': 'Photosensitizing agent'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",50.0,0.0255986,"Moreover, samples in group 2, group 3 and group 4 resulted in comparable bond strength (p > 0.05) CONCLUSION: MBP at 50 mg/","[{'ForeName': 'Abdulaziz Abdullah', 'Initials': 'AA', 'LastName': 'Al-Khureif', 'Affiliation': 'Dental Health Department, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia. Electronic address: aalkhuraif@ksu.edu.sa.'}, {'ForeName': 'Badreldin A', 'Initials': 'BA', 'LastName': 'Mohamed', 'Affiliation': 'Community Health Department, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia. Electronic address: badreldinmoah@gmail.com.'}, {'ForeName': 'Abdullah M', 'Initials': 'AM', 'LastName': 'Al-Shehri', 'Affiliation': 'Dental Health Department, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia. Electronic address: abdullahalshehri466@gmail.com.'}, {'ForeName': 'Aftab Ahmed', 'Initials': 'AA', 'LastName': 'Khan', 'Affiliation': 'Dental Biomaterials Research Chair, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia. Electronic address: aakjk@hotmail.com.'}, {'ForeName': 'Darshan Devang', 'Initials': 'DD', 'LastName': 'Divakar', 'Affiliation': 'Dental Biomaterials Research Chair, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia. Electronic address: dardevdiv@gmail.com.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101795']
88,32372486,Nitrates Do Not Affect Bone Density or Bone Turnover in Postmenopausal Women: A Randomized Controlled Trial.,"Organic nitrates have been reported to have significant effects on bone mineral density (BMD) and bone turnover in previous clinical trials. However, results are inconsistent and some trials with strikingly positive results have been retracted because of scientific misconduct. As preparation for a potential fracture prevention study, we set out to determine the lowest effective dose and the most effective and acceptable nitrate preparation. We undertook a 1-year, double-blind, randomized, placebo-controlled trial of three different nitrate preparations and two different doses in osteopenic postmenopausal women, with a planned 1-year observational extension. The primary endpoint was change in BMD at the lumbar spine, and secondary endpoints included BMD changes at other sites, changes in bone turnover markers, and adverse events. A total of 240 eligible women who tolerated low-dose oral nitrate treatment in a 2-week run-in period were randomized to five different treatment groups or placebo. Over 12 months, there were no statistically significant between-group differences in changes in BMD at any site and no consistent differences in bone turnover markers. When the active treatment groups were pooled, there were also no differences in changes in BMD or bone turnover markers between nitrate treatment and placebo. Eighty-eight (27%) women withdrew during the run-in phase, with the majority because of nitrate-induced headache, and 41 of 200 (21%) women randomized to nitrate treatment withdrew or stopped study medication during the 1-year study compared with 1 of 40 (2.5%) in the placebo group. In summary, organic nitrates do not have clinically relevant effects on BMD or bone turnover in postmenopausal women and were poorly tolerated. These results call into question the validity of previous clinical research reporting large positive effects of nitrates on BMD and bone turnover. © 2020 American Society for Bone and Mineral Research.",2020,"Over 12 months, there were no statistically significant between-group differences in changes in BMD at any site and no consistent differences in bone turnover markers.","['240 eligible women who tolerated low-dose oral nitrate treatment in a 2-week run-in period', 'Postmenopausal Women', 'Eighty-eight (27%) women withdrew during the run-in phase, with the majority because of nitrate-induced headache, and 41 of 200 (21%) women randomized to', 'postmenopausal women', '© 2020 American Society for Bone and Mineral Research', 'osteopenic postmenopausal women, with a planned 1-year observational extension']","['nitrate', 'placebo']","['BMD or bone turnover markers', 'bone mineral density (BMD) and bone turnover', 'Bone Density or Bone Turnover', 'BMD or bone turnover', 'BMD', 'bone turnover markers', 'BMD and bone turnover', 'BMD changes at other sites, changes in bone turnover markers, and adverse events', 'change in BMD at the lumbar spine']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}]",240.0,0.436884,"Over 12 months, there were no statistically significant between-group differences in changes in BMD at any site and no consistent differences in bone turnover markers.","[{'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Bolland', 'Affiliation': 'Department of Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Meaghan E', 'Initials': 'ME', 'LastName': 'House', 'Affiliation': 'Department of Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Horne', 'Affiliation': 'Department of Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Pinel', 'Affiliation': 'Department of Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Greg D', 'Initials': 'GD', 'LastName': 'Gamble', 'Affiliation': 'Department of Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Grey', 'Affiliation': 'Department of Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'Reid', 'Affiliation': 'Department of Medicine, University of Auckland, Auckland, New Zealand.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3982']
89,32362436,Effects of incentives on viral suppression in people living with HIV who use cocaine or opiates.,"BACKGROUND


Antiretroviral therapy (ART) adherence is essential to maintenance of undetectable viral loads among people living with HIV, which improves health and reduces HIV transmission. Despite these benefits, some people living with HIV do not maintain the level of adherence required to sustain an undetectable viral load. This problem is particularly common among people who use drugs.
OBJECTIVE


To determine effects of incentivizing viral suppression in people living with HIV who used cocaine or opiates.
METHODS


In this secondary analysis of data collected during a randomized controlled trial, participants (N=102) with detectable HIV viral loads (>200 copies/mL) were randomly assigned to a Usual Care or Incentive group. Usual Care participants did not earn incentives for viral suppression. Incentive participants earned incentives ($10/day maximum) for providing blood samples with reduced or undetectable (<200 copies/mL) viral loads. All participants completed assessments every three months. Results collected during the first year were compared based on group assignment and drug use.
RESULTS


Among participants who used cocaine or opiates, Incentive participants (n = 27) provided more (OR:4.0, CI:1.6-10.3, p = .004) blood samples with an undetectable viral load (69 %) than Usual Care participants (n = 25; 41 %). Among participants who did not use cocaine or opiates, Incentive participants (n = 25) provided more (OR:4.1, CI:1.5-10.7, p = .005) blood samples with an undetectable viral load (78 %) than Usual Care participants (n = 25; 36 %). Effects of incentives did not differ by drug use (OR:1.0, CI:0.3-4.0, p = .992).
CONCLUSIONS


Incentivizing viral suppression can promote undetectable viral loads in people living with HIV who use cocaine or opiates.",2020,"Effects of incentives did not differ by drug use (OR:1.0, CI:0.3-4.0, p = .992).
","['participants who did not use cocaine or opiates, Incentive participants (n = 25', 'people living with HIV who used cocaine or opiates', 'people who use drugs', 'people living with HIV who use cocaine or opiates', 'participants (N=102) with detectable HIV viral loads (>200 copies/mL', 'people living with HIV', 'participants who used cocaine or opiates, Incentive participants (n = 27']",['Usual Care or Incentive group'],['viral suppression'],"[{'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]",,0.168094,"Effects of incentives did not differ by drug use (OR:1.0, CI:0.3-4.0, p = .992).
","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Pollock', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for Learning and Health, Johns Hopkins University School of Medicine, 5200 Eastern Avenue Suite 350 East, Baltimore, MD, 21224, USA. Electronic address: spolloc6@jhu.edu.'}, {'ForeName': 'Forrest', 'Initials': 'F', 'LastName': 'Toegel', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for Learning and Health, Johns Hopkins University School of Medicine, 5200 Eastern Avenue Suite 350 East, Baltimore, MD, 21224, USA. Electronic address: ftoegel1@jhmi.edu.'}, {'ForeName': 'August F', 'Initials': 'AF', 'LastName': 'Holtyn', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for Learning and Health, Johns Hopkins University School of Medicine, 5200 Eastern Avenue Suite 350 East, Baltimore, MD, 21224, USA. Electronic address: aholtyn1@jhmi.edu.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Rodewald', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for Learning and Health, Johns Hopkins University School of Medicine, 5200 Eastern Avenue Suite 350 East, Baltimore, MD, 21224, USA. Electronic address: arodewa1@jhmi.edu.'}, {'ForeName': 'Jeannie-Marie', 'Initials': 'JM', 'LastName': 'Leoutsakos', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for Learning and Health, Johns Hopkins University School of Medicine, 5200 Eastern Avenue Suite 350 East, Baltimore, MD, 21224, USA. Electronic address: jeannie-marie@jhu.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fingerhood', 'Affiliation': 'Department of Medicine, Comprehensive Care Practice, Johns Hopkins Bayview Medical Center, 5200 Eastern Ave # W2, Baltimore, MD 21224, USA. Electronic address: mifinger@jhmi.edu.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Silverman', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for Learning and Health, Johns Hopkins University School of Medicine, 5200 Eastern Avenue Suite 350 East, Baltimore, MD, 21224, USA. Electronic address: ksilverm@jhmi.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108000']
90,32360090,Complications with focus on delirium during hospital stay related to femoral nerve block compared to conventional pain management among patients with hip fracture - A randomised controlled trial.,"INTRODUCTION


Patients with hip fracture often suffer complications leading to increased mortality and morbidity. Pain management are important, but opioids has many side effects. The aim of this study was to investigate whether Femoral Nerve Block (FNB) can reduce complications during hospital stay, with special focus on delirium compared to conventional pain management with opioids among patients with hip fracture, including those with dementia.
PATIENTS & METHODS


In a randomized controlled trial involving patients >70 years with hip fracture (trochanteric and cervical), including those with dementia. Preoperatively, patients (n=236) were consecutively assigned to receive FNB and opioids if required (intervention group, n = 116) or conventional pain management using opioids if required (control group, n = 120). Delirium was set according to different assessments and DSM-IV-TR criteria. Other complications were set by a specialist in geriatric medicine and a trained research nurse according to a predefined protocol.
RESULTS


Most patients, 157 (66%), were women, mean age was 84 (±6.7) years and 109 (46%) patients had dementia disorders. Forty-four patients (38.9%) developed delirium preoperatively in the intervention group compared to 59 (49.2%) patients in the control group (p=0.116). Common postoperative complications were pre- and postoperative delirium, nutritional problems, anaemia, constipation and urinary tract infection with no significant difference between the groups. In the subgroup analysis among patients with dementia, a large proportion developed delirium postoperative (96.3%) and they had a long duration of delirium during hospital stay (5.9 ±1.8), however no difference between the groups.
CONCLUSION


Despite less preoperative pain and need of opioids, FNB did not reduce the incidence of complications. However, a preoperative FNB may result in less preoperative delirium, but this should be further investigated. As pain treatment, FNB is a good alternative with few documented adverse effects in order to reduce pain and opioids among patients with hip fracture.",2020,"Common postoperative complications were pre- and postoperative delirium, nutritional problems, anaemia, constipation and urinary tract infection with no significant difference between the groups.","['Preoperatively, patients (n=236', 'patients >70 years with hip fracture (trochanteric and cervical), including those with dementia', 'patients had dementia disorders', 'patients with hip fracture', 'Most patients, 157 (66%), were women, mean age was 84 (±6.7) years and 109 (46', 'patients with hip fracture, including those with dementia']","['FNB and opioids if required (intervention group, n\xa0=\xa0116) or conventional pain management using opioids if required (control group, n\xa0=\xa0120', 'femoral nerve block', 'conventional pain management', 'Femoral Nerve Block (FNB']","['mortality and morbidity', 'delirium preoperatively', 'preoperative pain and need of opioids', 'pre- and postoperative delirium, nutritional problems, anaemia, constipation and urinary tract infection', 'delirium postoperative', 'long duration of delirium during hospital stay', 'incidence of complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0497327', 'cui_str': 'Dementia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0394739', 'cui_str': 'Local anesthetic femoral nerve block'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C3714509', 'cui_str': 'Nutritional disorder'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",236.0,0.116168,"Common postoperative complications were pre- and postoperative delirium, nutritional problems, anaemia, constipation and urinary tract infection with no significant difference between the groups.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Unneby', 'Affiliation': 'Department of Nursing and Department of Surgical and Perioperative Science Orthopedics, Umeå University, Umeå, Sweden. Electronic address: anna.unneby@umu.se.'}, {'ForeName': 'Professor Olle', 'Initials': 'PO', 'LastName': 'Svensson', 'Affiliation': 'Department of Surgical and Perioperative Science Orthopedics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Professor Yngve', 'Initials': 'PY', 'LastName': 'Gustafson', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Geriatric Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Associate Professor Britt-Marie', 'Initials': 'APB', 'LastName': 'Lindgren', 'Affiliation': 'Department of Nursing, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Ulrica', 'Initials': 'U', 'LastName': 'Bergström', 'Affiliation': 'Department of Surgical and Perioperative Science Orthopedics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Professor Birgitta', 'Initials': 'PB', 'LastName': 'Olofsson', 'Affiliation': 'Department of Nursing and Department of Surgical and Perioperative Science Orthopedics, Umeå University, Umeå, Sweden.'}]",Injury,['10.1016/j.injury.2020.04.013']
91,32378726,High-intensity arm resistance training does not lead to better outcomes than low-intensity resistance training in patients after subacute stroke: A randomized controlled trial.,"OBJECTIVE


To describe the effects of 2 levels of intensity of arm resistance training on grip strength, arm function, activities, participation, and adverse events in patients with subacute stroke.
DESIGN


A randomized controlled and preregistered trial with concealed allocation, assessor blinding and intention-to-treat analysis.
PATIENTS


Patients with subacute stroke and upper extremity hemiparesis.
METHODS


After randomization the experimental group received a 3-week high-intensity arm resistance training (HIT). The control group completed a 3-week low-intensity arm resistance training (LIT). The primary outcome was grip strength. Secondary outcomes included the Motricity Index, Fugl-Meyer Assessment for the upper limb, Box and Block Test, Goal Attainment Scale, Modified Ashworth Scale, and adverse events. All outcomes were assessed at baseline and after 3 weeks of intervention.
RESULTS


A total of 43 patients were investigated (HIT, n = 23; LIT, n = 20). All primary and secondary outcomes improved after the 3-week training, but no significant between-group differences were found. Adverse events occurred in 5% of training sessions (19/369).
CONCLUSION


The results of this study did not show differential effects on any outcome of 2 forms of arm resistance training in patients with subacute stroke.",2020,"Secondary outcomes included the Motricity Index, Fugl-Meyer Assessment for the upper limb, Box and Block Test, Goal Attainment Scale, Modified Ashworth Scale, and adverse events.","['patients with subacute stroke', '43 patients were investigated (HIT, n\u2009=\u200923; LIT, n\u2009=\u200920', 'patients after subacute stroke', 'Patients with subacute stroke and upper extremity hemiparesis']","['3-week high-intensity arm resistance training (HIT', 'low-intensity resistance training', 'High-intensity arm resistance training', '3-week low-intensity arm resistance training (LIT']","['Adverse events', 'grip strength, arm function, activities, participation, and adverse events', 'Motricity Index, Fugl-Meyer Assessment for the upper limb, Box and Block Test, Goal Attainment Scale, Modified Ashworth Scale, and adverse events', 'grip strength']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0018989', 'cui_str': 'Hemiparesis'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0451322', 'cui_str': 'Motricity index'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}]",43.0,0.0821925,"Secondary outcomes included the Motricity Index, Fugl-Meyer Assessment for the upper limb, Box and Block Test, Goal Attainment Scale, Modified Ashworth Scale, and adverse events.","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Högg', 'Affiliation': 'Department of Physiotherapy, Asklepios Kliniken Schildautal, , Seesen, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Holzgraefe', 'Affiliation': ''}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Drüge', 'Affiliation': ''}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Hauschild', 'Affiliation': ''}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Herrmann', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Obermann', 'Affiliation': ''}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Mehrholz', 'Affiliation': ''}]",Journal of rehabilitation medicine,['10.2340/16501977-2686']
92,32360038,Outcomes After Left Main Coronary Artery Revascularization by Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting According to Smoking Status.,"Cigarette smoking is a well-known risk factor for coronary artery disease (CAD). However, the impact of smoking on outcomes after coronary revascularization, especially in patients with left main CAD (LMCAD) is less well understood. The EXCEL trial randomized 1,905 patients with LMCAD and visually assessed low or intermediate anatomical complexity (SYNTAX score ≤32) to PCI with everolimus-eluting stents or CABG. Patients were categorized according to smoking status (current, former, or never), and their outcomes at 5 years were compared by logistic regression with follow-up time included as a log-transformed offset variable. The primary endpoint was a composite of death, myocardial infarction, or stroke. Among 1893 patients with known smoking status at baseline, 416 (22%) were current smokers and 774 (41%) were former smokers. The crude rates of the primary endpoint were 19.5% for never smokers, 20.5% for former smokers (p = 0.61 vs never smokers), and 23.1% for smokers (p = 0.15 vs never smokers). Compared with never smokers, the adjusted risk of the primary endpoint was higher for current smokers (adjOR 1.82, 95% confidence interval [CI] 1.126 to 2.63; p = 0.001), but not for former smokers (adjOR 1.00, 95% CI 0.75 to 1.33, p = 0.10). The relative efficacy of PCI versus CABG for the 5-year primary endpoint was similar irrespective of smoking status (P interaction  = 0.22). In conclusion, current smokers in the EXCEL trial had a higher adjusted 5-year risk of the primary composite endpoint of death, myocardial infarction, or stroke than never smokers, whereas former smokers were not at increased risk. Active smoking was a risk factor after LMCAD revascularization irrespective of revascularization method.",2020,"Compared with never smokers, the adjusted risk of the primary endpoint was higher for current smokers (adjOR 1.82, 95% confidence interval [CI] 1.126 to 2.63; p = 0.001), but not for former smokers (adjOR 1.00, 95% CI 0.75 to 1.33, p = 0.10).","['patients with left main CAD (LMCAD', '1,905 patients with LMCAD and visually assessed low or intermediate anatomical complexity (SYNTAX score ≤32) to', '1893 patients with known smoking status at baseline, 416 (22%) were current smokers and 774 (41%) were former smokers']","['PCI versus CABG', 'Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting', 'PCI with everolimus-eluting stents or CABG']","['composite of death, myocardial infarction, or stroke', 'death, myocardial infarction, or stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0337671', 'cui_str': 'Ex-smoker'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",1905.0,0.0367596,"Compared with never smokers, the adjusted risk of the primary endpoint was higher for current smokers (adjOR 1.82, 95% confidence interval [CI] 1.126 to 2.63; p = 0.001), but not for former smokers (adjOR 1.00, 95% CI 0.75 to 1.33, p = 0.10).","[{'ForeName': 'Bahira', 'Initials': 'B', 'LastName': 'Shahim', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Redfors', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden; NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Shmuel', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Morice', 'Affiliation': 'Hôpital privé Jacques Cartier, Ramsay Générale de Santé, Massy, France.'}, {'ForeName': 'Bernard J', 'Initials': 'BJ', 'LastName': 'Gersh', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Puskas', 'Affiliation': ""Mount Sinai Heart at Mount Sinai Saint Luke's, New York, New York.""}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kandzari', 'Affiliation': 'Piedmont Heart Institute, Atlanta, Georgia.'}, {'ForeName': 'Béla', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Heart and Vascular Center, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Ferenc', 'Initials': 'F', 'LastName': 'Horkay', 'Affiliation': 'Heart and Vascular Center, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Crowley', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, NUIG, National University of Ireland, Galway, Ireland; Imperial College of Science, Technology and Medicine, London, United Kingdom.'}, {'ForeName': 'Arie Pieter', 'Initials': 'AP', 'LastName': 'Kappetein', 'Affiliation': 'Thoraxcenter, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Sabik', 'Affiliation': 'Department of Surgery, UH Cleveland Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Ben-Yehuda', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: gstone@crf.org.'}]",The American journal of cardiology,['10.1016/j.amjcard.2020.04.029']
93,32361773,"Effects of turmeric extract supplementation on inflammation and muscle damage after a half-marathon race: a randomized, double-blind, placebo-controlled trial.","PURPOSE


Strenuous exercise induces inflammation and muscle damage. Turmeric (Curcuma longa L.) is a widely used spice that exhibits potent anti-inflammatory response and appears to decrease indirect markers of muscle damage. A randomized, double-blind, placebo-controlled trial was conducted to evaluate the effects of Curcuma longa L. extract (CLE) on inflammation and muscle damage after a half-marathon race.
METHODS


Twenty-eight healthy, normal-weight men were randomly assigned to one of two groups: (1) CLE (3 capsules per day, 500 mg each); or (2) placebo (PLA, 3 capsules per day, 500 mg of microcrystalline cellulose). Participants received the intervention for 4 weeks and immediately before and after the half-marathon race. Creatine kinase, lactate dehydrogenase, alanine aminotransferase, aspartate aminotransferase, myoglobin, interleukins 6 and 10 were assessed at baseline, immediately before, after, and at 2, 24, and 48 h after the half-marathon race.
RESULTS


The half-marathon race increased markers of inflammation and muscle damage. A greater increase in interleukin-10 was observed in the CLE group immediately after the competition compared to the PLA group (7.54 ± 1.45 vs 5.25 ± 0.59 pg/mL; p < 0.05; d = 0.55). Myoglobin concentration was lower 2 h after the race in participants from the CLE group compared to the PLA group (62.10 ± 8.26 vs 107.85 ± 18.45 ng/mL; p = 0.01; d = 0.86).
CONCLUSION


Curcuma longa L. extract supplementation leads to an increase in IL-10 and decreased myoglobin in recreational male runners after a half-marathon race.
TRIAL REGISTRATION NUMBER


U1111-1179-6335, February 13, 2016.",2020,Myoglobin concentration was lower 2 h after the race in participants from the CLE group compared to the PLA group (62.10 ± 8.26 vs 107.85 ± 18.45 ,"['recreational male runners after a half-marathon race', 'after a half-marathon race', 'Twenty-eight healthy, normal-weight men']","['turmeric extract supplementation', 'CLE', 'PLA', 'placebo (PLA, 3 capsules per day, 500\xa0mg of microcrystalline cellulose', 'Curcuma longa L. extract (CLE', 'Strenuous exercise', 'placebo']","['Creatine kinase, lactate dehydrogenase, alanine aminotransferase, aspartate aminotransferase, myoglobin, interleukins 6 and 10', 'IL-10 and decreased myoglobin', 'interleukin-10', 'Myoglobin concentration', 'inflammation and muscle damage']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0168374', 'cui_str': 'Marathon composite resin'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0077524', 'cui_str': 'Turmeric extract'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0669247', 'cui_str': 'microcrystalline cellulose'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0027078', 'cui_str': 'Myoglobin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}]",28.0,0.514186,Myoglobin concentration was lower 2 h after the race in participants from the CLE group compared to the PLA group (62.10 ± 8.26 vs 107.85 ± 18.45 ,"[{'ForeName': 'Flávia Rasmussen', 'Initials': 'FR', 'LastName': 'Faria', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (LABINCE), School of Nutrition, Federal University of Goiás, St. 227, Block 68, Setor Leste Universitário, Goiânia, GO, 74.605-080, Brazil.'}, {'ForeName': 'Aline Corado', 'Initials': 'AC', 'LastName': 'Gomes', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (LABINCE), School of Nutrition, Federal University of Goiás, St. 227, Block 68, Setor Leste Universitário, Goiânia, GO, 74.605-080, Brazil.'}, {'ForeName': 'Alisson', 'Initials': 'A', 'LastName': 'Antunes', 'Affiliation': 'Laboratory of Biopharmacy and Pharmacokinetics, Federal University of Goiás, Goiânia, GO, 74.605-080, Brazil.'}, {'ForeName': 'Kênnia Rocha', 'Initials': 'KR', 'LastName': 'Rezende', 'Affiliation': 'Laboratory of Biopharmacy and Pharmacokinetics, Federal University of Goiás, Goiânia, GO, 74.605-080, Brazil.'}, {'ForeName': 'Gustavo Duarte', 'Initials': 'GD', 'LastName': 'Pimentel', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (LABINCE), School of Nutrition, Federal University of Goiás, St. 227, Block 68, Setor Leste Universitário, Goiânia, GO, 74.605-080, Brazil.'}, {'ForeName': 'Camila Lemos Pinto', 'Initials': 'CLP', 'LastName': 'Oliveira', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (LABINCE), School of Nutrition, Federal University of Goiás, St. 227, Block 68, Setor Leste Universitário, Goiânia, GO, 74.605-080, Brazil.'}, {'ForeName': 'Barbara Moura', 'Initials': 'BM', 'LastName': 'Antunes', 'Affiliation': 'Department of Physical Education, Exercise and Immunometabolism Research Group, São Paulo State University (UNESP), Presidente Prudente, 19.060-900, Brazil.'}, {'ForeName': 'Fabio Santos', 'Initials': 'FS', 'LastName': 'Lira', 'Affiliation': 'Department of Physical Education, Exercise and Immunometabolism Research Group, São Paulo State University (UNESP), Presidente Prudente, 19.060-900, Brazil.'}, {'ForeName': 'Marcelo Saldanha', 'Initials': 'MS', 'LastName': 'Aoki', 'Affiliation': 'School of Arts, Sciences and Humanities, University of São Paulo, São Paulo, 03.828-000, Brazil.'}, {'ForeName': 'João Felipe', 'Initials': 'JF', 'LastName': 'Mota', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (LABINCE), School of Nutrition, Federal University of Goiás, St. 227, Block 68, Setor Leste Universitário, Goiânia, GO, 74.605-080, Brazil. jfemota@gmail.com.'}]",European journal of applied physiology,['10.1007/s00421-020-04385-7']
94,32360256,Multivessel Versus Culprit-Vessel Percutaneous Coronary Intervention in Cardiogenic Shock.,"OBJECTIVES


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


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


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


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


In patients with MVCAD presenting with AMICS treated with early MCS, revascularization of nonculprit lesions was associated with similar hospital survival and acute kidney injury when compared with culprit-only PCI. Selective nonculprit PCI can be safety performed in AMICS in patients supported with mechanical circulatory support.",2020,"Demographics between the cohorts were similar with respect to age, sex, history of diabetes, prior PCI or coronary artery bypass grafting, and prior history of myocardial infarction.","['patients enrolled in the NCSI (National Cardiogenic Shock Initiative) trial who were treated using a revascularization strategy of', 'patients with MVCAD presenting with AMICS treated with early MCS, revascularization of nonculprit lesions', 'patients supported with mechanical circulatory support', 'Cardiogenic Shock', '198 patients with MVCAD', 'patients with multivessel disease who present with acute myocardial infarction and cardiogenic shock (AMICS', 'Patients with multivessel coronary artery disease (MVCAD', 'patients treated with early mechanical circulatory support (MCS', 'From July 2016 to December 2019, patients who presented with AMICS to 57 participating hospitals']","['Culprit-Vessel Percutaneous\xa0Coronary Intervention', 'percutaneous coronary intervention (PCI) of multivessel PCI (MV-PCI) versus culprit-vessel PCI (CV-PCI', 'Multi']","['Survival and rates of acute kidney injury', 'hospital survival and acute kidney injury', 'severe impairment of cardiac output and worse lactate clearance on presentation, and cardiac performance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]",198.0,0.0717317,"Demographics between the cohorts were similar with respect to age, sex, history of diabetes, prior PCI or coronary artery bypass grafting, and prior history of myocardial infarction.","[{'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Lemor', 'Affiliation': 'Department of Cardiology, Henry Ford Hospital, Detroit, Michigan. Electronic address: alejandrolemor@outlook.com.'}, {'ForeName': 'Mir B', 'Initials': 'MB', 'LastName': 'Basir', 'Affiliation': 'Department of Cardiology, Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'Kirit', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': 'Department of Cardiology, St. Joseph Mercy Oakland, Pontiac, Michigan.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Kolski', 'Affiliation': ""Department of Cardiology, St. Joseph's Hospital-Orange, Orange, California.""}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Kaki', 'Affiliation': 'Department of Cardiology, Ascension St. John Hospital-Detroit, Detroit, Michigan.'}, {'ForeName': 'Navin K', 'Initials': 'NK', 'LastName': 'Kapur', 'Affiliation': 'Department of Cardiology, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Riley', 'Affiliation': 'The Christ Hospital Health Network, Cincinnati Ohio.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Finley', 'Affiliation': 'Department of Cardiology, Mercy Fitzgerald Hospital, Yeadon, Pennsylvania.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Goldsweig', 'Affiliation': 'Department of Cardiology, University of Nebraska, Omaha, Nebraska.'}, {'ForeName': 'Herbert D', 'Initials': 'HD', 'LastName': 'Aronow', 'Affiliation': 'Department of Cardiology, Alpert Medical School at Brown University, Providence, Rhode Island.'}, {'ForeName': 'P Matthew', 'Initials': 'PM', 'LastName': 'Belford', 'Affiliation': 'Department of Cardiology, Wake Forest Baptist Health, Winston-Salem, North Carolina.'}, {'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Tehrani', 'Affiliation': 'Department of Cardiology, Inova Fairfax Hospital, Falls Church, Virginia.'}, {'ForeName': 'Alexander G', 'Initials': 'AG', 'LastName': 'Truesdell', 'Affiliation': 'Department of Cardiology, Inova Fairfax Hospital, Falls Church, Virginia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lasorda', 'Affiliation': 'Department of Cardiology, Allegheny General Hospital, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Bharadwaj', 'Affiliation': 'Department of Cardiology, Loma Linda Medical Center, Loma Linda, California.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Hanson', 'Affiliation': 'Department of Cardiology, Beaumont Hospital-Royal Oak, Royal Oak, Michigan.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'LaLonde', 'Affiliation': 'Department of Cardiology, Ascension St. John Hospital-Detroit, Detroit, Michigan.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gorgis', 'Affiliation': 'Department of Cardiology, Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': ""O'Neill"", 'Affiliation': 'Department of Cardiology, Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.03.012']
95,32360887,Methodology and baseline characteristics of a randomized controlled trial testing a health care professional and peer-support program for patients with chronic obstructive pulmonary disease: The BREATHE2 study.,"BACKGROUND


Self-management support (SMS) for patients with COPD can improve health-related quality of life (HRQOL). However, it remains unclear what SMS strategies are most effective. Using peer support to advance self-management is promising, as peer supporters possess credibility and can serve as role models.
METHODS


We conducted a single-blinded RCT comparing the effectiveness of two strategies to support patients with COPD. The strategies were 'Health Care Professional (HCP)' and 'HCP Plus Peer' support. Peer support was provided by patients with COPD who have stopped smoking, completed an acute pulmonary rehabilitation program, and met the requirements for becoming a peer supporter. We enrolled patients receiving treatment at inpatient and outpatient settings. Patients were encouraged to invite one family-caregiver to enroll with them. The primary outcome measure was the change in HRQOL at 6 months post enrollment. Secondary outcomes included COPD-related and all-cause hospitalizations and ED visits. Caregiver outcomes included preparedness for caregiving, caregiver stress, and coping.
RESULTS


A total of 292 patients as well as 50 family-caregivers were enrolled. The average patient age was 67.3 yrs. (SD 9.4), 61% were female and 26% were African-Americans. The majority of caregivers were females (68%) and were a spouse/partner (58%).
DISCUSSION


This study tested a dual strategy for providing support to patients with COPD that incorporates peer and health care professional support. The study had minimal exclusion criteria. If shown effective, the study offers a program of peer support that can be readily implemented in health care settings.",2020,"BACKGROUND


Self-management support (SMS) for patients with COPD can improve health-related quality of life (HRQOL).","['patients with chronic obstructive pulmonary disease', 'patients with COPD that incorporates peer and health care professional support', 'patients with COPD', 'enrolled patients receiving treatment at inpatient and outpatient settings', 'patients with COPD who have stopped smoking, completed an acute pulmonary rehabilitation program, and met the requirements for becoming a peer supporter', '292 patients and into this study as well as 50 family-caregivers were enrolled']","['Self-management support (SMS', 'health care professional and peer-support program']","['COPD-related and all-cause hospitalizations and ED visits', 'health-related quality of life (HRQOL', 'preparedness for caregiving, caregiver stress, and coping', 'change in HRQOL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0425310', 'cui_str': 'Stopped smoking'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C1998980', 'cui_str': 'Caregiver role strain'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",292.0,0.0760412,"BACKGROUND


Self-management support (SMS) for patients with COPD can improve health-related quality of life (HRQOL).","[{'ForeName': 'Hanan', 'Initials': 'H', 'LastName': 'Aboumatar', 'Affiliation': 'Armstrong Institute for Patient Safety and Quality, The Johns Hopkins School of Medicine, 750 East Pratt Street, 15th floor, Baltimore, MD 21202, USA; Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 21218, USA; Department of Health, Behavior, and Society, Bloomberg School of Public Health, Johns Hopkins University, 601 North Caroline Street, Suite 2080, Baltimore, MD 21205, USA; Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, 2024 East Monument Street, Baltimore, MD 21287, USA. Electronic address: habouma1@jhmi.edu.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Naqibuddin', 'Affiliation': 'Armstrong Institute for Patient Safety and Quality, The Johns Hopkins School of Medicine, 750 East Pratt Street, 15th floor, Baltimore, MD 21202, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Neiman', 'Affiliation': 'Armstrong Institute for Patient Safety and Quality, The Johns Hopkins School of Medicine, 750 East Pratt Street, 15th floor, Baltimore, MD 21202, USA; Department of Internal Medicine, Hackensack University Medical Center, 30 Prospect Avenue, Hackensack, NJ 07601, USA.'}, {'ForeName': 'Jamia', 'Initials': 'J', 'LastName': 'Saunders', 'Affiliation': 'Armstrong Institute for Patient Safety and Quality, The Johns Hopkins School of Medicine, 750 East Pratt Street, 15th floor, Baltimore, MD 21202, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Armstrong Institute for Patient Safety and Quality, The Johns Hopkins School of Medicine, 750 East Pratt Street, 15th floor, Baltimore, MD 21202, USA.'}, {'ForeName': 'Hina', 'Initials': 'H', 'LastName': 'Chaudhry', 'Affiliation': 'Armstrong Institute for Patient Safety and Quality, The Johns Hopkins School of Medicine, 750 East Pratt Street, 15th floor, Baltimore, MD 21202, USA.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Garcia-Morales', 'Affiliation': 'Armstrong Institute for Patient Safety and Quality, The Johns Hopkins School of Medicine, 750 East Pratt Street, 15th floor, Baltimore, MD 21202, USA; Johns Hopkins University Bloomberg School of Public Health, 615 N Wolfe St, Baltimore, MD 21205, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Robinson', 'Affiliation': 'Johns Hopkins Bayview Medical Center, 4940 Eastern Ave, Baltimore, MD 21224, USA.'}, {'ForeName': 'Marjorie', 'Initials': 'M', 'LastName': 'McBurney', 'Affiliation': 'Johns Hopkins Bayview Medical Center, 4940 Eastern Ave, Baltimore, MD 21224, USA.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Jager', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, 615 N Wolfe St, Baltimore, MD 21205, USA.'}, {'ForeName': 'Tokunbo', 'Initials': 'T', 'LastName': 'Ajayi', 'Affiliation': 'Howard County General Hospital, 5755 Cedar Lane, Columbia, MD 21044, USA.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Bone', 'Affiliation': 'Department of Health, Behavior, and Society, Bloomberg School of Public Health, Johns Hopkins University, 601 North Caroline Street, Suite 2080, Baltimore, MD 21205, USA.'}, {'ForeName': 'Suna', 'Initials': 'S', 'LastName': 'Chung', 'Affiliation': 'Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, 2024 East Monument Street, Baltimore, MD 21287, USA.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Farrell', 'Affiliation': 'Howard County General Hospital, 5755 Cedar Lane, Columbia, MD 21044, USA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Joo Jin', 'Affiliation': 'Department of Psychiatry, Johns Hopkins School of Medicine, 600 North Wolfe Street, Baltimore, MD 21287, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Linnell', 'Affiliation': 'BREATHE2 Study, 750 East Pratt Street, 15th floor, Baltimore, MD 21202, USA.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Pirfo', 'Affiliation': 'Johns Hopkins Bayview Medical Center, 4940 Eastern Ave, Baltimore, MD 21224, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Rand', 'Affiliation': 'Pulmonary and Critical Care Medicine, The Johns Hopkins School of Medicine, 5501 Hopkins Bayview Circle, Baltimore, MD 21224, USA.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Riley', 'Affiliation': 'BREATHE2 Study, 750 East Pratt Street, 15th floor, Baltimore, MD 21202, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Salvaterra', 'Affiliation': 'Pulmonary Disease & Critical Care Medicine, Johns Hopkins Community Physicians, 11085 Little Patuxent Parkway, Columbia, MD 21044, USA.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Shea', 'Affiliation': 'Johns Hopkins Bayview Medical Center, 4940 Eastern Ave, Baltimore, MD 21224, USA.'}, {'ForeName': 'Jorawar', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'Howard County General Hospital, 5755 Cedar Lane, Columbia, MD 21044, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wise', 'Affiliation': 'Pulmonary and Critical Care Medicine, The Johns Hopkins School of Medicine, 5501 Hopkins Bayview Circle, Baltimore, MD 21224, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106023']
96,32374123,"The relation between the storage symptoms before and after transurethral resection of the prostate, analysis of the risk factors and the prevention of the symptoms with solifenacin.","OBJECTIVE AND HYPOTHESIS


We aimed to investigate the reasons of storage symptoms ( SS) after transurethral resection of the prostate (TURP). The hypothesis was that a positive correlation would be identified between preoperative and postoperative SS in patients with undergoing TURP and starting early solifenacin treatment in patients with high preoperative SS would be reasonable. In addition, we aimed to analyze multiple other risk factors for post-TURP SS.
MATERIALS AND METHODS


A total of 160 patients undergoing TURP were prospectively evaluated and divided into two groups according to their OABS. Those with a score of ≥10 points were Group 1 (G1), and those with < 10 points Group 2 (G2). In addition, patients in each group were randomly further divided into two subgroups: those who were started on 5 mg solifenacin succinate in the early postoperative period (G1/G2 A) and those who were not (G1/G2 B). In additions to SS Preop, perop and at the 3rd-month of postoperatively 14 variable were evaluated. The effects of these factors, surgery and the efficacy of an early medical treatment on the postoperative SS were investigated. LUTS were assessed by International Prostate Symptom Score (IPSS) and SS were assessed by sum of IPSS 2, 4 and 7 questionnaires (Storage, S- IPSS).
RESULTS


Preoperative IPSS and S-IPSS were significantly higher in G1 (p< 0.001); there was a significant improvement at IPSS, S-IPSS, QoL score, Qmax, and PVR for all groups after surgery. Only preoperative S-IPSS was found to have significant effect on postoperative SS (p< 0.001). There was a significant difference between G1A and G1B but no significant difference between G2A and G2B in terms of SS at postoperatively. In addition to this, prostatic volume was found smaller than non-symptomatic patients in de novo SS patients.
CONCLUSION


TURP provides significant improvement in both storage and voiding symptoms. The predictive value of the preoperative S-IPSS on postop SS is significant. These results suggest that 5 mg solifenacin succinate treatment in the early postoperative period may be beneficial for patients with high preoperative SS and may not be beneficial in others. Small prostatic volume may bode ill for postoperative SS in the patients with de novo SS.",2020,"RESULTS


Preoperative IPSS and S-IPSS were significantly higher in G1 (p< 0.001); there was a significant improvement at IPSS, S-IPSS, QoL score, Qmax, and PVR for all groups after surgery.","['patients with high preoperative SS', 'patients with de novo SS', '160 patients undergoing TURP']","['solifenacin succinate', 'TURP', 'transurethral resection of the prostate (TURP']","['prostatic volume', 'postoperative SS', 'G1A and G1B', 'storage and voiding symptoms', 'International Prostate Symptom Score (IPSS) and SS', 'Preoperative IPSS and S-IPSS', 'IPSS, S-IPSS, QoL score, Qmax, and PVR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}]","[{'cui': 'C1509436', 'cui_str': 'Solifenacin succinate'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}]","[{'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242852', 'cui_str': 'Proliferative vitreoretinopathy'}]",160.0,0.0169544,"RESULTS


Preoperative IPSS and S-IPSS were significantly higher in G1 (p< 0.001); there was a significant improvement at IPSS, S-IPSS, QoL score, Qmax, and PVR for all groups after surgery.","[{'ForeName': 'Timucin', 'Initials': 'T', 'LastName': 'Sipal', 'Affiliation': 'Depertment of Urology, Cerkezkoy State Hospital, Tekirdag, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Akdere', 'Affiliation': 'Depertmen of Urology, Trakya University Medical Faculty, Edirne, Turkey.'}]",International braz j urol : official journal of the Brazilian Society of Urology,['10.1590/S1677-5538.IBJU.2019.0227']
97,32374130,Editorial Comment: Laparoscopy versus robotic-assisted pyeloplasty in children: pre-liminary results of a pilot prospective ran-domized controlled trial.,,2020,,['children'],['Editorial Comment: Laparoscopy versus robotic-assisted pyeloplasty'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0282411', 'cui_str': 'Editorial Comment'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0554139', 'cui_str': 'Pyeloplasty'}]",[],,0.0347665,,"[{'ForeName': 'Eliney F', 'Initials': 'EF', 'LastName': 'Faria', 'Affiliation': 'Serviço de Urologia, Hospital Felicio Rocho, Belo Horizonte, MG, Brasil.'}]",International braz j urol : official journal of the Brazilian Society of Urology,['10.1590/S1677-5538.IBJU.2020.04.05']
98,32372217,"Effects of timing of moderate exercise in the evening on sleep and subsequent dietary intake in lean, young, healthy adults: randomized crossover study.","PURPOSE


This work studied the acute effects in healthy adults of evening exercise timing on their quality of sleep and dietary intake over the following 12 h.
METHODS


Sixteen men and women, (age: 22.3 ± 1.4 years; BMI: 20.8 ± 1.4 kg/m 2 , intermediate chronotype) took part in three randomized crossover sessions spread over three consecutive weeks: control session (CTL), 1 h exercise session at 6:30 pm (E6:30) and 1 h exercise session at 8:30 pm (E8:30), in which exercise finished 4 h and 2 h before habitual bedtime, respectively. Exercise was an outdoor run at 60% HR maxth . Energy expenditure and sleep were ambulatories monitored by accelerometry under free-living condition. Ad-libitum dinner and breakfast were used to measure subsequent energy intake and proportion of that energy derived from each macronutrient.
RESULTS


Evening exercise did not disrupt sleep. Improvement in sleep quality compared to the control condition was observed only when exercise was performed 4 h before habitual bedtime (WASO: p < 0.01; SE: p < 0.02). Interestingly, our results give insight into differences in sleep parameters response to evening exercise between habitually poor and good sleepers mainly when it comes to sleep efficiency and wake after sleep onset (all p < 0.01). There was no difference in calorie intake from ad-libitum dinner and breakfast. However, an association between improvement in sleep efficiency from acute exercise and reduction of energy intake the following morning was found.
CONCLUSION


Early evening exercise could offer a useful alternative for achieving better sleep in healthy young adults especially when it comes to poor sleepers.",2020,Improvement in sleep quality compared to the control condition was observed only when exercise was performed 4 h before habitual bedtime (WASO: p < 0.01; SE: p < 0.02).,"['healthy young adults', 'Sixteen men and women, (age: 22.3\u2009±\u20091.4\xa0years; BMI: 20.8\u2009±\u20091.4\xa0kg/m 2 , intermediate chronotype) took part', 'healthy adults', 'lean, young, healthy adults']","['control session (CTL), 1\xa0h exercise session at 6:30\xa0pm (E6:30) and 1\xa0h exercise session', 'moderate exercise']","['calorie intake', 'sleep quality', 'sleep efficiency', 'energy intake']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",16.0,0.0228493,Improvement in sleep quality compared to the control condition was observed only when exercise was performed 4 h before habitual bedtime (WASO: p < 0.01; SE: p < 0.02).,"[{'ForeName': 'Oussama', 'Initials': 'O', 'LastName': 'Saidi', 'Affiliation': 'Laboratory of Adaptations To Exercise Under Physiological and Pathological Conditions (AME2P), Clermont Auvergne University, 63000, Clermont-Ferrand, France.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Davenne', 'Affiliation': 'INSERMUMR-S 1075 COMETE, Caen Normandie University, Caen, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Lehorgne', 'Affiliation': 'Laboratory of Adaptations To Exercise Under Physiological and Pathological Conditions (AME2P), Clermont Auvergne University, 63000, Clermont-Ferrand, France.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Duché', 'Affiliation': 'Laboratory of Adaptations To Exercise Under Physiological and Pathological Conditions (AME2P), Clermont Auvergne University, 63000, Clermont-Ferrand, France. pascale.duche@univ-tln.fr.'}]",European journal of applied physiology,['10.1007/s00421-020-04386-6']
99,32369989,Effectiveness of Mediterranean Diet Implementation in Dry Eye Parameters: A Study of PREDIMED-PLUS Trial.,"The purpose of this study is to evaluate the effect of a Mediterranean diet supplemented with extra virgin olive oil and nuts on dry eye parameters. The participants in this study were randomized into one of the two interventional arms: (1) a standard intervention group, a Mediterranean diet supplemented with extra virgin olive oil and nuts; and (2) an intensive intervention group, based on a hypocaloric Mediterranean diet and an intensive lifestyle program with physical activity and weight-loss goals. In both groups, common dry eye tests were conducted at baseline and after six months: the Ocular Surface Disease Index (OSDI), the Dry Eye Scoring System (DESS), tear break-up time (TBUT), the Schirmer's test, and the Oxford staining grade. Sixty-seven eyes were examined. After six months, dry eye parameters improved in both groups; differences between groups were favorable for the intensive intervention group. The implementation of a Mediterranean diet pattern was beneficial for the selected patients with dry eye, and could be beneficial for patients with dry eye in general. Behavioral support for diet adherence and the promotion of healthy lifestyles (exercise) and weight loss (calorie restriction) have an added positive effect.",2020,"After six months, dry eye parameters improved in both groups; differences between groups were favorable for the intensive intervention group.","['Sixty-seven eyes', 'Dry Eye Parameters']","['Mediterranean diet supplemented with extra virgin olive oil and nuts', 'Mediterranean Diet Implementation', 'Mediterranean diet pattern', 'standard intervention group, a Mediterranean diet supplemented with extra virgin olive oil and nuts; and (2) an intensive intervention group, based on a hypocaloric Mediterranean diet and an intensive lifestyle program with physical activity and weight-loss goals']","['healthy lifestyles (exercise) and weight loss (calorie restriction', 'dry eye parameters', ""Ocular Surface Disease Index (OSDI), the Dry Eye Scoring System (DESS), tear break-up time (TBUT), the Schirmer's test, and the Oxford staining grade""]","[{'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]","[{'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0028723', 'cui_str': 'Nut'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]","[{'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test""}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",67.0,0.0153005,"After six months, dry eye parameters improved in both groups; differences between groups were favorable for the intensive intervention group.","[{'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Molina-Leyva', 'Affiliation': 'Department of Ophthalmology, Hospital Virgen de las Nieves, 999023 Granada, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Molina-Leyva', 'Affiliation': 'Department of Dermatology, Hospital Virgen de las Nieves, 999023 Granada, Spain.'}, {'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Riquelme-Gallego', 'Affiliation': 'Department of Preventive Medicine and Public Health, Universidad de Granada, 999023 Granada, Spain.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Cano-Ibáñez', 'Affiliation': 'Department of Preventive Medicine and Public Health, Universidad de Granada, 999023 Granada, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'García-Molina', 'Affiliation': 'Department of Preventive Medicine and Public Health, Universidad de Granada, 999023 Granada, Spain.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Bueno-Cavanillas', 'Affiliation': 'Department of Preventive Medicine and Public Health, Universidad de Granada, 999023 Granada, Spain.'}]",Nutrients,['10.3390/nu12051289']
100,32370147,Water Consumption during a School Day and Children's Short-Term Cognitive Performance: The CogniDROP Randomized Intervention Trial.,"There is still little research examining the relationship between water consumption in school and specific cognitive performance. The aim of this cluster-randomized intervention CogniDROP trial was to investigate the short-term effects of drinking water during the morning on executive functions. The participants were from the 5 th  and 6 th  grade of a comprehensive school in Germany (14 classes,  n  = 250, 61.6% boys). The classes were randomly divided into an intervention group (an education on healthy drinking behavior and a promotion of water consumption) and a control group. A battery of computerized tasks (Switch Task, 2-Back Task, Corsi Block-Tapping Task and Flanker Task) was used to test executive functions. Urine color and thirst were evaluated to check the hydration level. Physical activity over the past 24 h was measured using GT3X ActiGraph. A non-linear relationship was observed between the amount of drinking water and executive performance. Consuming water up to 1000 mL (or up to 50% of Total Water Intake) had benefits during memory tasks. Urine color and number of steps on the study day correlated with water consumed. The results suggest that a water-friendly environment supports school-aged children in adequate water intake resulting in better cognitive performance, especially short-term memory.",2020,"The results suggest that a water-friendly environment supports school-aged children in adequate water intake resulting in better cognitive performance, especially short-term memory.","[""Water Consumption during a School Day and Children's Short-Term Cognitive Performance"", 'participants were from the 5 th  and 6 th  grade of a comprehensive school in Germany (14 classes,  n  = 250, 61.6% boys']","['intervention group (an education on healthy drinking behavior and a promotion of water consumption) and a control group', 'computerized tasks (Switch Task, 2-Back Task, Corsi Block-Tapping Task and Flanker Task']","['executive functions', 'Physical activity', 'Urine color and number of steps', 'drinking water and executive performance']","[{'cui': 'C0013123', 'cui_str': 'Water intake'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0557796', 'cui_str': 'Comprehensive school'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0870221', 'cui_str': 'Male child'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0013124', 'cui_str': 'Drinking Behavior'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0013123', 'cui_str': 'Water intake'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0278030', 'cui_str': 'Color of urine'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]",,0.0274991,"The results suggest that a water-friendly environment supports school-aged children in adequate water intake resulting in better cognitive performance, especially short-term memory.","[{'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Drozdowska', 'Affiliation': ""Research Department of Child Nutrition, University Children's Hospital, Ruhr University Bochum, 44791 Bochum, Germany.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Falkenstein', 'Affiliation': 'Institute for Work, Learning and Ageing (ALA), 44805 Bochum, Germany.'}, {'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Jendrusch', 'Affiliation': 'Department of Sports Medicine and Sports Nutrition, Ruhr University Bochum, 44801 Bochum, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Platen', 'Affiliation': 'Department of Sports Medicine and Sports Nutrition, Ruhr University Bochum, 44801 Bochum, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Luecke', 'Affiliation': ""Research Department of Child Nutrition, University Children's Hospital, Ruhr University Bochum, 44791 Bochum, Germany.""}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Kersting', 'Affiliation': ""Research Department of Child Nutrition, University Children's Hospital, Ruhr University Bochum, 44791 Bochum, Germany.""}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Jansen', 'Affiliation': ""Research Department of Child Nutrition, University Children's Hospital, Ruhr University Bochum, 44791 Bochum, Germany.""}]",Nutrients,['10.3390/nu12051297']
101,32370159,The Effect of a Multicomponent Dual-Task Exercise on Cortical Thickness in Older Adults with Cognitive Decline: A Randomized Controlled Trial.,"The aim of this study was to examine cortical thickness changes associated with a multicomponent exercise intervention combining physical exercise and cognitive training in older adults with cognitive decline. This study involved a secondary analysis of neuroimaging data from a randomized controlled trial with 280 older adults having cognitive decline who were randomly assigned to either a multicomponent exercise group ( n  = 140) that attended weekly 90-minute exercise and cognitive training sessions or a health education control group ( n  = 140). The cortical thickness and cognitive performance were assessed at the baseline and at trial completion (10 months). The cortical thickness in the frontal and temporal regions was determined using FreeSurfer software. Cognitive performance was evaluated using the Gerontology-Functional Assessment Tool (NCGG-FAT). The cortical thickness significantly increased in the middle temporal ( p  < 0.001) and temporal pole ( p  < 0.001) in the multicomponent exercise group compared with the control group. Cortical thickness changes were significantly associated with change in trail making test (TMT)-A, TMT-B, and story memory after a 10-month multicomponent exercise intervention. This study suggests that multicomponent exercise programs combining physical exercise and cognitive training have important implications for brain health, especially in providing protection from age-related cortical thinning.",2020,"Cortical thickness changes were significantly associated with change in trail making test (TMT)-A, TMT-B, and story memory after a 10-month multicomponent exercise intervention.","['280 older adults having cognitive decline', 'Older Adults with Cognitive Decline', 'older adults with cognitive decline']","['multicomponent exercise programs combining physical exercise and cognitive training', 'Multicomponent Dual-Task Exercise', 'multicomponent exercise intervention combining physical exercise and cognitive training', 'multicomponent exercise group ( n  = 140) that attended weekly 90-minute exercise and cognitive training sessions or a health education control group', 'multicomponent exercise']","['Cortical Thickness', 'cortical thickness', 'Cortical thickness changes', 'trail making test (TMT)-A, TMT-B, and story memory', 'cortical thickness and cognitive performance', 'Cognitive performance']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0040604', 'cui_str': 'Trail making test'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",280.0,0.0537647,"Cortical thickness changes were significantly associated with change in trail making test (TMT)-A, TMT-B, and story memory after a 10-month multicomponent exercise intervention.","[{'ForeName': 'Seongryu', 'Initials': 'S', 'LastName': 'Bae', 'Affiliation': 'Department of Preventive Gerontology, Center for Gerontology and Social Science, National Center for Geriatrics and Gerontology, Obu 474-8511, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Harada', 'Affiliation': 'Department of Preventive Gerontology, Center for Gerontology and Social Science, National Center for Geriatrics and Gerontology, Obu 474-8511, Japan.'}, {'ForeName': 'Sangyoon', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Preventive Gerontology, Center for Gerontology and Social Science, National Center for Geriatrics and Gerontology, Obu 474-8511, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Harada', 'Affiliation': 'Department of Preventive Gerontology, Center for Gerontology and Social Science, National Center for Geriatrics and Gerontology, Obu 474-8511, Japan.'}, {'ForeName': 'Keitaro', 'Initials': 'K', 'LastName': 'Makino', 'Affiliation': 'Department of Preventive Gerontology, Center for Gerontology and Social Science, National Center for Geriatrics and Gerontology, Obu 474-8511, Japan.'}, {'ForeName': 'Ippei', 'Initials': 'I', 'LastName': 'Chiba', 'Affiliation': 'Department of Preventive Gerontology, Center for Gerontology and Social Science, National Center for Geriatrics and Gerontology, Obu 474-8511, Japan.'}, {'ForeName': 'Hyuntae', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Department of Preventive Gerontology, Center for Gerontology and Social Science, National Center for Geriatrics and Gerontology, Obu 474-8511, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Shimada', 'Affiliation': 'Department of Preventive Gerontology, Center for Gerontology and Social Science, National Center for Geriatrics and Gerontology, Obu 474-8511, Japan.'}]",Journal of clinical medicine,['10.3390/jcm9051312']
102,32370906,"Editorial Commentary: Spinning ""Spin"" in Randomized Trials in Orthopaedic Surgery.","Reporting the results of a randomized trial can be complex. In some cases, the primary outcome may not achieve statistical significance (usually defined as P ≤ .05) but the information may be clinically meaningful. ""Spinning"" the results of a study to show them to be more favorable than they are in reality is a form of reporting bias. The best way around potential reporting bias is for readers to read the methods section first to evaluate exactly what was done, followed by the results section to interpret the outcomes and analysis. Then, and only then, can readers decide whether the findings are relevant to them and their patients.",2020,"In some cases, the primary outcome may not achieve statistical significance (usually defined as P ≤ .05) but the information may be clinically meaningful.",[],[],[],[],[],[],,0.0566112,"In some cases, the primary outcome may not achieve statistical significance (usually defined as P ≤ .05) but the information may be clinically meaningful.","[{'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Marx', 'Affiliation': 'New York, New York.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2020.02.041']
103,32372433,"Re: Pravastatin for early-onset pre-eclampsia: a randomised, blinded, placebo-controlled trial.",,2020,,['early-onset pre-eclampsia'],"['Re: Pravastatin', 'placebo']",[],"[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}]","[{'cui': 'C0085542', 'cui_str': 'Pravastatin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.772416,,"[{'ForeName': 'Liliana S', 'Initials': 'LS', 'LastName': 'Voto', 'Affiliation': 'Departamento Materno infantil, Hospital General de Agudos Dr. Juan A. Fernández, Ciudad de Buenos Aires, Argentina.'}, {'ForeName': 'Moises G', 'Initials': 'MG', 'LastName': 'Zeitune', 'Affiliation': 'Departamento Materno infantil, Hospital General de Agudos Dr. Juan A. Fernández, Ciudad de Buenos Aires, Argentina.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16240']
104,32370253,Effects of Combined Transcranial Direct Current Stimulation with Cognitive Training in Girls with Rett Syndrome.,"BACKGROUND


Transcranial Direct Current Stimulation (tDCS) combined with traditional rehabilitative techniques has not been widely applied to Rett Syndrome (RTT). The aim of this study was to examine the effects of combined cognitive traditional training with tDCS applied to attention and language measures in subjects with RTT.
METHODS


31 subjects with RTT were randomly allocated into two groups: non-sham tDCS ( n  = 18) and sham tDCS ( n  = 13). The former received the integrated intervention non-sham tDCS plus cognitive empowerment during the treatment phase. The latter received sham stimulation plus cognitive empowerment. All participants underwent neurological and cognitive assessment to evaluate attention and language measures: before integrated treatment (pre-test phase), at the conclusion of the treatment (post-test phase), and at 1 month after the conclusion of the treatment (follow-up phase).
RESULTS


the results indicated longer attention time in the non-sham tDCS group compared to the sham tDCS group with a stable trend also in the follow-up phase; an increase of the number of vowel/phoneme sounds in the non-sham tDCS group; and an improvement in the neurophysiological parameters in the non-sham tDCS group.
CONCLUSIONS


This study supports the use of tDCS as a promising and alternative approach in the RTT rehabilitation field.",2020,"the results indicated longer attention time in the non-sham tDCS group compared to the sham tDCS group with a stable trend also in the follow-up phase; an increase of the number of vowel/phoneme sounds in the non-sham tDCS group; and an improvement in the neurophysiological parameters in the non-sham tDCS group.
","['Girls with Rett Syndrome', 'subjects with RTT', '31 subjects with RTT']","['sham tDCS', 'tDCS', 'combined cognitive traditional training with tDCS', 'integrated intervention non-sham tDCS plus cognitive empowerment', 'non-sham tDCS', 'sham stimulation plus cognitive empowerment', 'Transcranial Direct Current Stimulation (tDCS) combined with traditional rehabilitative techniques', 'Combined Transcranial Direct Current Stimulation with Cognitive Training']","['number of vowel/phoneme sounds', 'longer attention time', 'neurophysiological parameters']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035372', 'cui_str': ""Rett's disorder""}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",31.0,0.0389347,"the results indicated longer attention time in the non-sham tDCS group compared to the sham tDCS group with a stable trend also in the follow-up phase; an increase of the number of vowel/phoneme sounds in the non-sham tDCS group; and an improvement in the neurophysiological parameters in the non-sham tDCS group.
","[{'ForeName': 'Rosa Angela', 'Initials': 'RA', 'LastName': 'Fabio', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Messina, Via Bivona, 98100 Messina, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gangemi', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Messina, Via Bivona, 98100 Messina, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Semino', 'Affiliation': 'Centro AIRETT Ricerca e Innovazione (CARI), Research and Innovation Airett Center, 37100 Verona, Italy.'}, {'ForeName': 'Aglaia', 'Initials': 'A', 'LastName': 'Vignoli', 'Affiliation': 'Department of Health Sciences, Child Neuropsychiatry Unit, Epilepsy Center, San Paolo Hospital, Universitàdegli Studi di Milano, 20142 Milan, Italy.'}, {'ForeName': 'Maria Paola', 'Initials': 'MP', 'LastName': 'Canevini', 'Affiliation': 'Department of Health Sciences, Child Neuropsychiatry Unit, Epilepsy Center, San Paolo Hospital, Universitàdegli Studi di Milano, 20142 Milan, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Priori', 'Affiliation': 'Aldo Ravelli Research Center for Neurotechnology and Experimental Neurotheraputics, Department of Health Sciences, University of Milan, 20142 Milan, Italy.'}, {'ForeName': 'Gabriella Di', 'Initials': 'GD', 'LastName': 'Rosa', 'Affiliation': 'Division of Child Neurology and Psychiatry, G. Martino Hospital, University of Messina, Via Consolare Pompea, 46046 Messina, Italy.'}, {'ForeName': 'Tindara', 'Initials': 'T', 'LastName': 'Caprì', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Messina, Via Bivona, 98100 Messina, Italy.'}]",Brain sciences,['10.3390/brainsci10050276']
105,32372290,Pooled Safety and Tolerability Analysis of Empagliflozin in Patients with Type 2 Diabetes Mellitus.,"INTRODUCTION


The aim of this analysis was to characterize the safety and tolerability of empagliflozin in patients with type 2 diabetes mellitus (T2DM) who were randomized to empagliflozin (10/25 mg) or placebo in clinical trials.
METHODS


Pooled data from 20 trials were analyzed for patients with T2DM treated with empagliflozin 10 mg (n = 4858), empagliflozin 25 mg (n = 5057), or placebo (n = 4904). The dataset comprised 15 randomized phase I-III trials, an extension trial and dose escalation studies. Adverse events (AEs) were assessed descriptively in participants who took ≥ 1 dose of study drug. AE incidence rates per 100 patient-years were calculated to adjust for differences in drug exposure between trials.
RESULTS


Total exposure was 16,480 and 7857 patient-years in the pooled empagliflozin 10/25 mg and placebo groups, respectively. The incidence of any AEs, AEs leading to treatment discontinuation, severe AEs, and serious AEs was similar across groups. The frequency of serious AEs requiring hospitalization was 18.6% for the empagliflozin 10/25 mg group and 21.3% for the placebo group. The empagliflozin 10/25 mg group was not associated with a higher rate of confirmed hypoglycemia versus placebo, except in patients co-administered insulin and/or a sulfonylurea (31.5% vs. 30.2%, respectively). The incidence of events consistent with urinary tract infections (UTI) was also similar for the empagliflozin 10/25 mg group versus placebo (9.27 vs. 9.70/100 patient-years, respectively). History of UTI was identified as a risk factor for UTI during treatment. Events consistent with genital infections occurred more frequently with empagliflozin 10/25 mg than placebo (3.54 vs. 0.95/100 patient-years, respectively). The frequency of AEs consistent with volume depletion was similar across groups, but higher with empagliflozin 10/25 mg than placebo in patients aged 75 to < 85 years and those on loop diuretics at baseline.
CONCLUSION


This comprehensive analysis confirms that both empagliflozin 10 mg and 25 mg are well tolerated in patients with T2DM, reinforcing the established clinical safety profile of empagliflozin.",2020,Events consistent with genital infections occurred more frequently with empagliflozin,"['10\xa0mg (n\u2009=\u20094858', 'Total exposure was 16,480 and 7857 patient-years in the pooled', 'Patients with Type 2 Diabetes Mellitus', 'patients with type 2 diabetes mellitus (T2DM', 'Pooled data from 20 trials were analyzed for patients with T2DM treated with', 'patients with T2DM']","['empagliflozin 25\xa0mg (n\u2009=\u20095057), or placebo', 'Empagliflozin', 'empagliflozin', 'placebo']","['AE incidence rates', 'genital infections', 'higher rate of confirmed hypoglycemia', 'safety and tolerability', 'incidence of any AEs, AEs leading to treatment discontinuation, severe AEs, and serious AEs', 'Adverse events (AEs', 'incidence of events consistent with urinary tract infections (UTI', 'frequency of AEs consistent with volume depletion', 'frequency of serious AEs requiring hospitalization']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C3848772', 'cui_str': 'empagliflozin 25 MG [Jardiance]'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0729552', 'cui_str': 'Genital infection'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0546884', 'cui_str': 'Hypovolemia'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",,0.314442,Events consistent with genital infections occurred more frequently with empagliflozin,"[{'ForeName': 'Ona', 'Initials': 'O', 'LastName': 'Kinduryte Schorling', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Clark', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Zwiener', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kaspers', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Jisoo', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Hristo', 'Initials': 'H', 'LastName': 'Iliev', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany. hristo.iliev@boehringer-ingelheim.com.'}]",Advances in therapy,['10.1007/s12325-020-01329-7']
106,32370930,Long-term changes in delay discounting following a smoking cessation treatment for patients with depression.,"BACKGROUND


Delay discounting (DD) has been identified as a trans-disorder process underlying addictive behaviors, including smoking. Previous studies have evaluated how different treatments for drug dependence have affected DD, showing mixed results. Furthermore, no study has examined the effects of changes in depression on DD rates. The aim of this study was to evaluate the impact of treatment type: cognitive behavioral treatment (CBT), CBT + behavioral activation (BA), or CBT + BA + contingency management (CM), and changes in smoking status and depression on DD rates in long-term follow-up among a sample of treatment-seeking smokers with depression.
METHODS


Participants were 180 treatment-seeking smokers with depression who were randomly assigned to one of the following treatment conditions: CBT (n = 60), CBT + BA (n = 60), and CBT + BA + CM (n = 60). Depressive symptomatology and major depression diagnosis were evaluated through the BDI-II and the SCID-I of the DSM-IV-TR. DD rates were assessed using the DD task with hypothetical monetary rewards. Smoking status, DD, and depressive symptomatology were collected at baseline, at end-of-treatment and at one-, two-, three-, and six-month follow-ups.
RESULTS


CM for smoking cessation reduces DD rates (p = .0094). Smoking abstinence (p = .0024) and reduction in depressive symptoms (p = .0437) were associated with decreases in DD rates in long-term follow-up.
CONCLUSIONS


CM interventions for smoking cessation, smoking abstinence, and the improvement of depression contribute to reductions in DD over time.",2020,"Smoking abstinence (p = .0024) and reduction in depressive symptoms (p = .0437) were associated with decreases in DD rates in long-term follow-up.
","['patients with depression', 'Participants were 180 treatment-seeking smokers with depression']","['CBT', 'CBT + BA + CM', 'cognitive behavioral treatment (CBT), CBT + behavioral activation (BA), or CBT + BA + contingency management (CM', 'CBT + BA']","['Depressive symptomatology and major depression diagnosis', 'Smoking status, DD, and depressive symptomatology', 'Smoking abstinence', 'smoking status and depression on DD rates', 'DD rates', 'delay discounting', 'depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3850035', 'cui_str': 'Intertemporal Preferences'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",180.0,0.0288067,"Smoking abstinence (p = .0024) and reduction in depressive symptoms (p = .0437) were associated with decreases in DD rates in long-term follow-up.
","[{'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'García-Pérez', 'Affiliation': 'Department of Psychology. University of Oviedo, Plaza Feijoo, s/n, 33003 Oviedo, Spain. Electronic address: garciaperangel@uniovi.es.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Vallejo-Seco', 'Affiliation': 'Department of Psychology. University of Oviedo, Plaza Feijoo, s/n, 33003 Oviedo, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Weidberg', 'Affiliation': 'Department of Psychology. University of Oviedo, Plaza Feijoo, s/n, 33003 Oviedo, Spain.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'González-Roz', 'Affiliation': 'Department of Psychology. University of Oviedo, Plaza Feijoo, s/n, 33003 Oviedo, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Secades-Villa', 'Affiliation': 'Department of Psychology. University of Oviedo, Plaza Feijoo, s/n, 33003 Oviedo, Spain.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108007']
107,32370931,Financial incentives promote engagement in employment services for unemployed adults in treatment for opioid use disorder.,"BACKGROUND


Promoting employment among unemployed adults with substance use disorder is a difficult challenge for which existing interventions have had limited effects. This study examined whether financial incentives could increase engagement in employment services for unemployed adults in treatment for opioid use disorder.
METHODS


The study was conducted from 2014 to 2019 in Baltimore, MD. After a 3-month abstinence initiation and training period, participants (N = 91) were randomly assigned to a Control group or an Incentive group and were invited to work with an employment specialist to seek employment in a community job for 12 months. Participants assigned to the Control group (n = 47) did not receive incentives for working with the employment specialist. Participants assigned to the Incentive group (n = 44) could earn financial incentives for working with the employment specialist, but had to provide opiate- and cocaine-negative urine samples to maximize pay.
RESULTS


Incentive participants attended the employment services and worked with the employment specialist on significantly more days than Control participants (41.8 % versus 1.1 % of days; OR = 40.42, 95 % CI = 32.46-48.38, p < .001), and for significantly more hours than Control participants (3.58 versus 1.25 h, on average; OR=2.34, 95 % CI=1.83-2.85, p < .001). Incentive participants were more likely to be retained than Control participants when analyses were based solely on attendance (HR=0.12, 95 % CI=0.06-0.25, p < .001) and attendance and employment combined (HR=0.15, 95 % CI=0.07-0.31, p < .001).
CONCLUSIONS


Financial incentives were effective in promoting engagement in employment services for individuals who often do not utilize employment services.",2020,"Incentive participants were more likely to be retained than Control participants when analyses were based solely on attendance (HR=0.12, 95 % CI=0.06-0.25, p < .001) and attendance and employment combined (HR=0.15, 95 % CI=0.07-0.31, p < .001).
","['2014 to 2019 in Baltimore, MD', 'unemployed adults with substance use disorder', 'unemployed adults', 'unemployed adults in treatment for opioid use disorder', 'individuals who often do not utilize employment services']","['Control group (n = 47) did not receive incentives for working with the employment specialist', 'Control group or an Incentive group and were invited to work with an employment specialist to seek employment in a community job for 12 months', 'Incentive group (n = 44) could earn financial incentives for working with the employment specialist, but had to provide opiate- and cocaine-negative urine samples to maximize pay']",['employment services and worked with the employment specialist'],"[{'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}]","[{'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}]",91.0,0.153669,"Incentive participants were more likely to be retained than Control participants when analyses were based solely on attendance (HR=0.12, 95 % CI=0.06-0.25, p < .001) and attendance and employment combined (HR=0.15, 95 % CI=0.07-0.31, p < .001).
","[{'ForeName': 'August F', 'Initials': 'AF', 'LastName': 'Holtyn', 'Affiliation': 'Johns Hopkins University School of Medicine, USA. Electronic address: aholtyn1@jhmi.edu.'}, {'ForeName': 'Forrest', 'Initials': 'F', 'LastName': 'Toegel', 'Affiliation': 'Johns Hopkins University School of Medicine, USA.'}, {'ForeName': 'Shrinidhi', 'Initials': 'S', 'LastName': 'Subramaniam', 'Affiliation': 'Johns Hopkins University School of Medicine, USA.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Arellano', 'Affiliation': 'Johns Hopkins University School of Medicine, USA.'}, {'ForeName': 'Jeannie-Marie', 'Initials': 'JM', 'LastName': 'Leoutsakos', 'Affiliation': 'Johns Hopkins University School of Medicine, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fingerhood', 'Affiliation': 'Johns Hopkins University School of Medicine, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Silverman', 'Affiliation': 'Johns Hopkins University School of Medicine, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.107982']
108,32371534,"A prospective, controlled study of non-motor effects of subthalamic stimulation in Parkinson's disease: results at the 36-month follow-up.","OBJECTIVE


To examine 36-month effects of bilateral subthalamic nucleus deep brain stimulation (STN-DBS) on non-motor symptoms (NMS) compared with standard-of-care medical treatment (MED) in Parkinson's disease (PD).
METHODS


Here we report the 36-month follow-up of a prospective, observational, controlled, international multicentre study of the NILS cohort. Assessments included NMSScale (NMSS), PDQuestionnaire-8 (PDQ-8), Scales for Outcomes in PD (SCOPA)-motor examination, -activities of daily living, and -complications, and levodopa equivalent daily dose (LEDD). Propensity score matching resulted in a pseudo-randomised sub-cohort balancing baseline demographic and clinical characteristics between the STN-DBS and MED groups. Within-group longitudinal outcome changes were analysed using Wilcoxon signed-rank and between-group differences of change scores with Mann-Whitney U test. Strength of clinical responses was quantified with Cohen's effect size. In addition, bivariate correlations of change scores were explored.
RESULTS


Propensity score matching applied on the cohort of 151 patients (STN-DBS n=67, MED n=84) resulted in a well-balanced sub-cohort including 38 patients per group. After 36 months, STN-DBS significantly improved NMSS, PDQ-8, SCOPA-motor examination and -complications and reduced LEDD. Significant between-group differences, all favouring STN-DBS, were found for NMSS, SCOPA-motor complications, LEDD (large effects), motor examination and PDQ-8 (moderate effects). Furthermore, significant differences were found for the sleep/fatigue, urinary (large effects) and miscellaneous NMSS domains (moderate effects). NMSS total and PDQ-8 change scores correlated significantly.
CONCLUSIONS


This study provides Class IIb evidence for beneficial effects of STN-DBS on NMS at 36-month follow-up which also correlated with quality of life improvements. This highlights the importance of NMS for DBS outcomes assessments.",2020,"After 36 months, STN-DBS significantly improved NMSS, PDQ-8, SCOPA-motor examination and -complications and reduced LEDD.","[""Parkinson's disease"", ""Parkinson's disease (PD""]","['subthalamic stimulation', 'bilateral subthalamic nucleus deep brain stimulation (STN-DBS', 'standard-of-care medical treatment (MED', 'STN-DBS']","['NMSScale (NMSS), PDQuestionnaire-8 (PDQ-8), Scales for Outcomes in PD (SCOPA)-motor examination, -activities of daily living, and -complications, and levodopa equivalent daily dose (LEDD', 'NMSS, PDQ-8, SCOPA-motor examination and -complications and reduced LEDD', 'NMSS total and PDQ-8 change scores', 'sleep/fatigue, urinary (large effects) and miscellaneous NMSS domains', 'NMSS, SCOPA-motor complications, LEDD (large effects), motor examination and PDQ-8 (moderate effects', 'quality of life improvements']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0152355', 'cui_str': 'Nucleus of Luys'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205395', 'cui_str': 'Miscellaneous'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",151.0,0.0752582,"After 36 months, STN-DBS significantly improved NMSS, PDQ-8, SCOPA-motor examination and -complications and reduced LEDD.","[{'ForeName': 'Stefanie Theresa', 'Initials': 'ST', 'LastName': 'Jost', 'Affiliation': 'Department of Neurology, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Sauerbier', 'Affiliation': 'Department of Neurology, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Visser-Vandewalle', 'Affiliation': 'Department of Stereotaxy and Functional Neurosurgery, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Keyoumars', 'Initials': 'K', 'LastName': 'Ashkan', 'Affiliation': ""Parkinson Foundation International Centre of Excellence, King's College Hospital, London, UK.""}, {'ForeName': 'Monty', 'Initials': 'M', 'LastName': 'Silverdale', 'Affiliation': 'Department of Neurology and Neurosurgery, Salford Royal NHS Foundation Trust, Manchester Academic Health Science Centre, Greater Manchester, UK.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Evans', 'Affiliation': 'Department of Neurology and Neurosurgery, Salford Royal NHS Foundation Trust, Manchester Academic Health Science Centre, Greater Manchester, UK.'}, {'ForeName': 'Philipp A', 'Initials': 'PA', 'LastName': 'Loehrer', 'Affiliation': 'Department of Neurology, University Hospital of Giessen and Marburg, Campus Marburg, Marburg, Hessen, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Rizos', 'Affiliation': ""Parkinson Foundation International Centre of Excellence, King's College Hospital, London, UK.""}, {'ForeName': 'Jan Niklas', 'Initials': 'JN', 'LastName': 'Petry-Schmelzer', 'Affiliation': 'Department of Neurology, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Reker', 'Affiliation': 'Department of Neurology, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Gereon Rudolf', 'Initials': 'GR', 'LastName': 'Fink', 'Affiliation': 'Department of Neurology, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Franklin', 'Affiliation': 'Institute of Medical Statistics and Computational Biology (IMSB), University of Cologne, Köln, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Samuel', 'Affiliation': ""Parkinson Foundation International Centre of Excellence, King's College Hospital, London, UK.""}, {'ForeName': 'Alfons', 'Initials': 'A', 'LastName': 'Schnitzler', 'Affiliation': 'Department of Neurology, Center for Movement Disorders and Neuromodulation, Heinrich-Heine-University Duesseldorf, Duesseldorf, Germany.'}, {'ForeName': 'Michael Thomas', 'Initials': 'MT', 'LastName': 'Barbe', 'Affiliation': 'Department of Neurology, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Antonini', 'Affiliation': 'Parkinson and Movement Disorders Unit, IRCCS Hospital San Camillo, Venice, Italy.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Martinez-Martin', 'Affiliation': 'Center for Networked Biomedical Research on Neurodegenerative Diseases, Madrid, Spain.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Timmermann', 'Affiliation': 'Department of Neurology, University Hospital of Giessen and Marburg, Campus Marburg, Marburg, Hessen, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Ray-Chaudhuri', 'Affiliation': ""Parkinson Foundation International Centre of Excellence, King's College Hospital, London, UK.""}, {'ForeName': 'Haidar S', 'Initials': 'HS', 'LastName': 'Dafsari', 'Affiliation': 'Department of Neurology, University Hospital Cologne, Cologne, Germany haidar.salimi-dafsari@uk-koeln.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Journal of neurology, neurosurgery, and psychiatry",['10.1136/jnnp-2019-322614']
109,32371657,Impact of diabetes on clinical outcome among elderly patients with acute coronary syndrome treated with percutaneous coronary intervention: insights from the ELDERLY ACS 2 trial.,"BACKGROUND


Despite recent improvements in percutaneous coronary revascularization and antithrombotic therapies for the treatment of acute coronary syndromes, the outcome is still unsatisfactory in high-risk patients, such as the elderly and patients with diabetes. The aim of the current study was to investigate the prognostic impact of diabetes on clinical outcome among patients included in the Elderly-ACS 2 trial, a randomized, open-label, blinded endpoint study carried out at 32 centers in Italy.
METHODS


Our population is represented by 1443 patients included in the Elderly-ACS 2 trial. Diabetes was defined as known history of diabetes at admission. The primary endpoint of this analysis was cardiovascular mortality, while secondary endpoints were all-cause death, recurrent myocardial infarction, Bleeding Academic Research Consortium type 2 or 3 bleeding, and rehospitalization for cardiovascular event or stent thrombosis within 12 months after index admission.
RESULTS


Diabetes was present in 419 (29%) out of 1443 patients. Diabetic status was significantly associated with major cardiovascular risk factors and history of previous coronary disease, presentation with non-ST segment elevation myocardial infarction (P = 0.01) more extensive coronary disease (P = 0.02), more advanced Killip class at presentation (P = 0.003), use at admission of statins (P = 0.004) and diuretics at discharge (P < 0.001). Median follow-up was 367 days (interquartile range: 337-378 days). Diabetic status was associated with an absolute increase in the rate of cardiovascular mortality as compared with patients without diabetes [5.5 vs. 3.3%, hazard ratio (HR) 1.7 (0.99-2.8), P = 0.054], particularly among those treated with clopidogrel [HR (95% confidence interval (CI)) = 1.89 (0.93-3.87), P = 0.08]. However, this difference disappeared after correction for baseline differences [Adjusted HR (95% CI) 1.1(0.4-2.9), P = 0.86]. Similar findings were observed for other secondary endpoints, except for bleeding complications, significantly more frequent in diabetic patients [HR (95% CI) 2.02 (1.14-3.6), P = 0.02; adjusted HR (95% CI) = 2.1 (1.01-4.3), P = 0.05]. No significant interaction was observed between type of dual antiplatelet therapy, diabetic status and outcome.
CONCLUSION


Among elderly patients with acute coronary syndromes, diabetic status was associated with higher rates of comorbidities, more severe cardiovascular risk profile and major bleeding complications fully accounting for the absolute increase in mortality. In fact, diabetes mellitus did not emerge as an independent predictor of survival in advanced age.",2020,"Diabetic status was associated with an absolute increase in the rate of cardiovascular mortality as compared with patients without diabetes [5.5 vs. 3.3%, hazard ratio (HR) 1.7 (0.99-2.8), P = 0.054], particularly among those treated with clopidogrel [HR (95% confidence interval (CI)) = ","['Diabetes was present in 419 (29%) out of 1443 patients', 'patients included in the Elderly-ACS 2 trial, a randomized, open-label, blinded endpoint study carried out at 32 centers in Italy', '1443 patients included in the Elderly-ACS 2 trial', 'elderly and patients with diabetes', 'elderly patients with acute coronary syndrome treated with', 'elderly patients with acute coronary syndromes']","['percutaneous coronary revascularization and antithrombotic therapies', 'percutaneous coronary intervention']","['extensive coronary disease', 'diabetic patients [HR', 'cause death, recurrent myocardial infarction, Bleeding Academic Research Consortium type 2 or 3 bleeding, and rehospitalization for cardiovascular event or stent thrombosis', 'bleeding complications', 'rate of cardiovascular mortality', 'severe cardiovascular risk profile and major bleeding complications', 'major cardiovascular risk factors and history of previous coronary disease, presentation with non-ST segment elevation myocardial infarction', 'mortality', 'cardiovascular mortality', 'Diabetic status', 'advanced Killip class']","[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0002455', 'cui_str': 'American Cancer Society'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0010068', 'cui_str': 'Coronary Heart Disease'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C1536221', 'cui_str': 'Non ST segment elevation myocardial infarction'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0456387', 'cui_str': 'Class'}]",1443.0,0.0929041,"Diabetic status was associated with an absolute increase in the rate of cardiovascular mortality as compared with patients without diabetes [5.5 vs. 3.3%, hazard ratio (HR) 1.7 (0.99-2.8), P = 0.054], particularly among those treated with clopidogrel [HR (95% confidence interval (CI)) = ","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'De Luca', 'Affiliation': ""Azienda Ospedaliera-Universitaria 'Maggiore della Carità', Eastern Piedmont University, Novara.""}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Verdoia', 'Affiliation': ""Azienda Ospedaliera-Universitaria 'Maggiore della Carità', Eastern Piedmont University, Novara.""}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Savonitto', 'Affiliation': 'Ospedale Manzoni, Lecco.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Piatti', 'Affiliation': 'Ospedale Manzoni, Lecco.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Grosseto', 'Affiliation': 'Ospedale Infermi, Rimini.'}, {'ForeName': 'Nuccia', 'Initials': 'N', 'LastName': 'Morici', 'Affiliation': 'ASST Grande Ospedale Metropolitano Niguarda, Milano.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Bossi', 'Affiliation': 'ASST Grande Ospedale Metropolitano Niguarda, Milano.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Sganzerla', 'Affiliation': 'Ospedale Treviglio-Caravaggio, Treviglio.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Tortorella', 'Affiliation': 'IRCCS Arcispedale S. Maria Nuova, Reggio Emilia.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cacucci', 'Affiliation': 'Ospedale Maggiore, Crema, Italy.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Murena', 'Affiliation': 'Ospedale S. Maria delle Grazie, Pozzuoli, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Toso', 'Affiliation': 'Ospedale S. Stefano, Prato, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Bongioanni', 'Affiliation': 'Ospedale Mauriziano, Torino, Italy.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Ravera', 'Affiliation': ""Ospedale Ruggi D' Aragona, Salerno, Italy.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Corrada', 'Affiliation': 'Humanitas Clinical and Research Center, Rozzano, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Mariani', 'Affiliation': 'Ospedale Civile, Legnano, Italy.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Di Ascenzo', 'Affiliation': 'Ospedale di San Donà di Piave-Portogruaro, Portogruaro, Italy.'}, {'ForeName': 'Anna S', 'Initials': 'AS', 'LastName': 'Petronio', 'Affiliation': 'Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Cavallini', 'Affiliation': 'Ospedale S. Maria della Misericordia, Perugia, Italy.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Vitrella', 'Affiliation': 'Ospedali Riuniti di Trieste, Trieste, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Antonicelli', 'Affiliation': ""Istituto Nazionale di Ricerca e Cura per l' Anziano, Ancona, Italy.""}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Rogacka', 'Affiliation': 'Statistics and Biomathematics Unit, Department of Molecular and Transactional Medicine, University of Brescia, Brescia.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'De Servi', 'Affiliation': 'Multimedica IRCSS, Milan, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Journal of cardiovascular medicine (Hagerstown, Md.)",['10.2459/JCM.0000000000000978']
110,32371183,Optimization of CT windowing for diagnosing invasiveness of adenocarcinoma presenting as sub-solid nodules.,"PURPOSE


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


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


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


At 120 kVp, core window setting (WW/WL, 1175/35 HU) outperformed the traditional mediastinal window setting to diagnose the invasiveness of SSNs.",2020,"In testing group, the sensitivity, specificity, positive, negative predictive value, and diagnostic accuracy for SSN invasiveness were 49.4%, 90.5%, 95.7%, 29.7%, and 57.3% for mediastinal window setting, and 87.6%, 76.2%, 91.6%, 76.2%, and 85.5% for core window setting.
","['lung adenocarcinoma in sub-solid nodules (SSNs', 'Of the 437 SSNs, 88 were pre-invasive [17 atypical adenomatous hyperplasia (AAH) and 71 adenocarcinoma in situ (AIS', '437 SSNs', ' 349 were invasive [233 minimally invasive adenocarcinoma (MIA), 116 invasive adenocarcinoma (IA']",['CT'],"['sensitivity, specificity, positive, negative predictive value, and diagnostic accuracy for SSN invasiveness']","[{'cui': 'C0152013', 'cui_str': 'Adenocarcinoma of lung'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0028259', 'cui_str': 'Nodule'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0334001', 'cui_str': 'Atypical glandular hyperplasia'}, {'cui': 'C0334000', 'cui_str': 'Glandular hyperplasia'}, {'cui': 'C0334276', 'cui_str': 'Adenocarcinoma in situ'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C4517541', 'cui_str': '116'}]",[],"[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C1301821', 'cui_str': 'Social security number'}, {'cui': 'C1301757', 'cui_str': 'Invasiveness'}]",233.0,0.0224966,"In testing group, the sensitivity, specificity, positive, negative predictive value, and diagnostic accuracy for SSN invasiveness were 49.4%, 90.5%, 95.7%, 29.7%, and 57.3% for mediastinal window setting, and 87.6%, 76.2%, 91.6%, 76.2%, and 85.5% for core window setting.
","[{'ForeName': 'Xiaonan', 'Initials': 'X', 'LastName': 'Cui', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Centre of Cancer, Key Laboratory of Cancer Prevention and Therapy, Department of Radiology, Tianjin, People's Republic of China; University of Groningen, University Medical Center Groningen, Department of Radiology, Groningen, the Netherlands.""}, {'ForeName': 'Shuxuan', 'Initials': 'S', 'LastName': 'Fan', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Centre of Cancer, Key Laboratory of Cancer Prevention and Therapy, Department of Radiology, Tianjin, People's Republic of China.""}, {'ForeName': 'Marjolein A', 'Initials': 'MA', 'LastName': 'Heuvelmans', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Epidemiology, Groningen, the Netherlands; Medisch Spectrum Twente, Department of Pulmonology, Enschede, the Netherlands.'}, {'ForeName': 'Daiwei', 'Initials': 'D', 'LastName': 'Han', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Radiology, Groningen, the Netherlands.'}, {'ForeName': 'Yingru', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Centre of Cancer, Key Laboratory of Cancer Prevention and Therapy, Department of Radiology, Tianjin, People's Republic of China.""}, {'ForeName': 'Harry J M', 'Initials': 'HJM', 'LastName': 'Groen', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Pulmonary Diseases, Groningen, the Netherlands.'}, {'ForeName': 'Monique D', 'Initials': 'MD', 'LastName': 'Dorrius', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Radiology, Groningen, the Netherlands; University of Groningen, University Medical Center Groningen, Department of Epidemiology, Groningen, the Netherlands.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Oudkerk', 'Affiliation': 'Institute for Diagnostic Accuracy (iDNA) BV, Groningen, the Netherlands; University of Groningen, Faculty of Medical Sciences, Groningen, the Netherlands.'}, {'ForeName': 'Geertruida H', 'Initials': 'GH', 'LastName': 'de Bock', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Epidemiology, Groningen, the Netherlands.'}, {'ForeName': 'Rozemarijn', 'Initials': 'R', 'LastName': 'Vliegenthart', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Radiology, Groningen, the Netherlands.'}, {'ForeName': 'Zhaoxiang', 'Initials': 'Z', 'LastName': 'Ye', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Centre of Cancer, Key Laboratory of Cancer Prevention and Therapy, Department of Radiology, Tianjin, People's Republic of China. Electronic address: yezhaoxiang@163.com.""}]",European journal of radiology,['10.1016/j.ejrad.2020.108981']
111,32378975,Effect of neuromuscular electrical stimulation on skeletal muscle size and function in patients with breast cancer receiving chemotherapy.,"Exercise has numerous benefits for patients with cancer, but implementation is challenging because of practical and logistical hurdles. This study examined whether neuromuscular electrical stimulation (NMES) can serve as a surrogate for classic exercise by eliciting an exercise training response in skeletal muscle of women diagnosed with breast cancer undergoing chemotherapy. Patients ( n  = 22) with histologically confirmed stage I, II, or III breast cancer scheduled to receive neoadjuvant or adjuvant chemotherapy were randomized to 8 wk of bilateral neuromuscular electrical stimulation (NMES; 5 days/wk) to their quadriceps muscles or control. Biopsy of the vastus lateralis was performed at baseline and after 8 wk of intervention to assess muscle fiber size, contractility, and mitochondrial content. Seventeen patients (8 control/9 NMES) completed the trial and were included in analyses. NMES promoted muscle fiber hypertrophy ( P  < 0.001), particularly in fast-twitch, myosin heavy chain (MHC) IIA fibers ( P  < 0.05) and tended to induce fiber type shifts in MHC II fibers. The effects of NMES on single-muscle fiber contractility were modest, and it was unable to prevent declines in the function in MHC IIA fibers. NMES did not alter intermyofibrillar mitochondrial content/structure but was associated with reductions in subsarcolemmal mitochondria. Our results demonstrate that NMES induces muscle fiber hypertrophy and fiber type shifts in MHC II fibers but had minimal effects on fiber contractility and promoted reductions in subsarcolemmal mitochondria. Further studies are warranted to evaluate the utility of NMES as an exercise surrogate in cancer patients and other conditions. NEW & NOTEWORTHY  This is the first study to evaluate whether neuromuscular electrical stimulation (NMES) can be used as an exercise surrogate to improve skeletal muscle fiber size or function in cancer patients receiving treatment. We show that NMES promoted muscle fiber hypertrophy and fiber type shifts but had minimal effects on single-fiber contractility and reduced subsarcolemmal mitochondria.",2020,"NMES promoted muscle fiber hypertrophy (P<0.001), particularly in fast-twitch, myosin heavy chain (MHC)","['patients with cancer', 'Seventeen patients (8 control/9 NMES) completed the trial and were included in analyses', 'Patients (n=22) with histologically-confirmed, stage I, II or III breast cancer scheduled to receive', 'women diagnosed with breast cancer undergoing chemotherapy', 'patients with breast cancer receiving chemotherapy']","['neuromuscular electrical stimulation', 'NMES', 'neuromuscular electrical stimulation (NMES', 'neoadjuvant or adjuvant chemotherapy', 'bilateral neuromuscular electrical stimulation (NMES; 5 days/week) to their quadriceps muscles or control', 'Exercise']","['fast-twitch, myosin heavy chain (MHC', 'skeletal muscle size and function', 'muscle fiber hypertrophy', 'subsarcolemmal mitochondria']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0677547', 'cui_str': 'days/week'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}, {'cui': 'C0027100', 'cui_str': 'Myosin Heavy Chain'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0333759', 'cui_str': 'Muscle fiber hypertrophy'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}]",22.0,0.0485888,"NMES promoted muscle fiber hypertrophy (P<0.001), particularly in fast-twitch, myosin heavy chain (MHC)","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Toth', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Voigt', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Tourville', 'Affiliation': 'Department of Orthopedics and Rehabilitation, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Shannon M', 'Initials': 'SM', 'LastName': 'Prior', 'Affiliation': 'Vermont Cancer Center, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Blas A', 'Initials': 'BA', 'LastName': 'Guigni', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Axel V', 'Initials': 'AV', 'LastName': 'Schlosberg', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Isaac B', 'Initials': 'IB', 'LastName': 'Smith', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Taylor J', 'Initials': 'TJ', 'LastName': 'Forest', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Kaufman', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Marie E', 'Initials': 'ME', 'LastName': 'Wood', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Hibba', 'Initials': 'H', 'LastName': 'Rehman', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Dittus', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00203.2020']
112,32311925,Evaluation of photobiomodulation in salivary production of patients with xerostomy induced by anti-hypertensive drugs: Study protocol clinical trial (SPIRIT compliant).,"INTRODUCTION


Hypertension (systemic arterial hypertension [SAH]) is a systemic condition that affects about 30% of the world population, according to data from the World Health Organization (WHO). Drugs used to control this disease have the potential to induce xerostomia, an oral condition in which the decrease of the salivary flow is observed and whose presence leads to the increase of the index of caries, periodontal disease, loss of the teeth, dysgeusia, difficulty of mastication, dysphagia, bad breath and oral burning and impairment of prothesis installed in the buccal cavity, including retention of removable and total dentures.
METHODS


This is a randomized, placebo-controlled, blind clinical protocol that aims to analyze the impact of phobiomodulation (PBM) on salivary glands of patients with antihypertensive drug induced xerostomia. Patients will be divided into 2 groups: G1: older adults with xerostomia induced by antihypertensive drugs and treatment with PBM (n = 30); G2: placebo PBM (n = 30). The irradiation will be made using a diode laser emitting at 808 nm with 100 mW and 40 seconds of exposure per site at the salivary glands. Twenty sites will be irradiated weekly for 4 weeks. Non-stimulated and stimulated salivary flow will be analyzed before and after the treatment.
RESULTS


This protocol will determine the effectiveness of photodynamic therapy regarding the reduction of xerostomia in older adults using antihypertensive drugs.
CONCLUSION


This protocol will determine the effectiveness of photodynamic therapy regarding the reduction of xerostomia in older adults using antihypertensive drugs.
TRIAL REGISTRATION


Clinicaltrials.gov - NCT03632096.",2020,Patients will be divided into 2 groups: G1: older adults with xerostomia induced by antihypertensive drugs and treatment with PBM (n = 30); G2: placebo PBM (n = 30).,"['patients with xerostomy induced by anti-hypertensive drugs', 'n\u200a=\u200a30', 'Patients will be divided into 2 groups: G1: older adults with xerostomia induced by antihypertensive drugs and treatment with PBM (n\u200a=\u200a30); G2', 'patients with antihypertensive drug induced xerostomia', 'older adults using antihypertensive drugs']","['placebo PBM', 'phobiomodulation (PBM', 'placebo', 'photobiomodulation', 'photodynamic therapy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}]",[],,0.152994,Patients will be divided into 2 groups: G1: older adults with xerostomia induced by antihypertensive drugs and treatment with PBM (n = 30); G2: placebo PBM (n = 30).,"[{'ForeName': 'Maria Lucia Zarvos', 'Initials': 'MLZ', 'LastName': 'Varellis', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, University Nove de Julho (UNINOVE), Rua Vergueiro, Liberdade, São Paulo, Brazil.'}, {'ForeName': 'Marcela Leticia Leal', 'Initials': 'MLL', 'LastName': 'Gonçalves', 'Affiliation': ''}, {'ForeName': 'Vanessa Christina Santos', 'Initials': 'VCS', 'LastName': 'Pavesi', 'Affiliation': ''}, {'ForeName': 'Anna Carolina Ratto Tempestini', 'Initials': 'ACRT', 'LastName': 'Horliana', 'Affiliation': ''}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'de Fátima Teixeira da Silva', 'Affiliation': ''}, {'ForeName': 'Lara Jansiski', 'Initials': 'LJ', 'LastName': 'Motta', 'Affiliation': ''}, {'ForeName': 'Valdomiro F', 'Initials': 'VF', 'LastName': 'Barbosa Filho', 'Affiliation': ''}, {'ForeName': 'Cícero Dayves Silva', 'Initials': 'CDS', 'LastName': 'Bezerra', 'Affiliation': ''}, {'ForeName': 'Felipe Gonçalves da', 'Initials': 'FGD', 'LastName': 'Silva', 'Affiliation': ''}, {'ForeName': 'Sandra Kalil', 'Initials': 'SK', 'LastName': 'Bussadori', 'Affiliation': ''}, {'ForeName': 'Alessandro M', 'Initials': 'AM', 'LastName': 'Deana', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000019583']
113,32379118,A Randomized Trial of Static and Articulating Spacers for the Treatment of Infection Following Total Knee Arthroplasty.,"BACKGROUND


There is no consensus whether the interim antibiotic spacer utilized in the 2-stage exchange arthroplasty should immobilize the joint or allow for motion. The purpose of this multicenter, randomized clinical trial was to compare static and articulating spacers as part of the 2-stage exchange arthroplasty for the treatment of chronic periprosthetic joint infection complicating total knee arthroplasty as defined with use of Musculoskeletal Infection Society criteria.
METHODS


Sixty-eight patients undergoing 2-stage exchange arthroplasty were randomized to either a static (32 patients) or an articulating (36 patients) spacer. An a priori power analysis determined that 28 patients per group would be necessary to detect a 13° difference in range of motion between groups. Six patients were excluded after randomization, 6 died, and 7 were lost to follow-up before 2 years.
RESULTS


Patients in the static group had a hospital length of stay that was 1 day greater than the articulating group after stage 1 (6.1 compared with 5.1 days; 95% confidence interval [CI], 5.3 to 6.9 days and 4.6 to 5.6 days, respectively; p = 0.032); no other differences were noted perioperatively. At a mean of 3.5 years (range, 2.0 to 6.4 years), 49 patients were available for evaluation. The mean motion arc was 113.0° (95% CI, 108.4° to 117.6°) in the articulating spacer group, compared with 100.2° (95% CI, 94.2° to 106.1°) in the static spacer group (p = 0.001). The mean Knee Society Score was higher in the articulating spacer cohort (79.4 compared with 69.8 points; 95% CI, 72.4 to 86.3 and 63.6 to 76.1, respectively; p = 0.043). Although not significantly different with the sample size studied, static spacers were associated with a greater need for an extensile exposure at the time of reimplantation (16.7% compared with 4.0%; 95% CI, 0.6% to 38.9% and 0.5% to 26.3%, respectively; p = 0.189) and a higher rate of reoperation (25.0% compared with 8.0%; 95% CI, 9.8% to 46.7% and 1.0% to 26.0%, respectively; p = 0.138).
CONCLUSIONS


Articulating spacers provided significantly greater range of motion and higher Knee Society scores at a mean of 3.5 years. Static spacers were associated with a longer hospital stay following removal of the infected implant. When the soft-tissue envelope allows and if there is adequate osseous support, an articulating spacer is associated with improved outcomes.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"RESULTS


Patients in the static group had a hospital length of stay that was 1 day greater than the articulating group after stage 1 (6.1 compared with 5.1 days; 95% confidence interval [CI], 5.3 to 6.9 days and 4.6 to 5.6 days, respectively; p = 0.032); no other differences were noted perioperatively.","['Total Knee Arthroplasty', 'chronic periprosthetic joint infection complicating total knee arthroplasty', 'Sixty-eight patients undergoing 2-stage exchange arthroplasty']","['2-stage exchange arthroplasty', 'Static and Articulating Spacers']","['range of motion and higher Knee Society scores', 'hospital length of stay', 'mean Knee Society Score', 'rate of reoperation', 'mean motion arc', 'hospital stay']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0157749', 'cui_str': 'Arthropathy associated with infection'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}]","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0221874', 'cui_str': 'Spacer'}]","[{'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",68.0,0.234311,"RESULTS


Patients in the static group had a hospital length of stay that was 1 day greater than the articulating group after stage 1 (6.1 compared with 5.1 days; 95% confidence interval [CI], 5.3 to 6.9 days and 4.6 to 5.6 days, respectively; p = 0.032); no other differences were noted perioperatively.","[{'ForeName': 'Cindy R', 'Initials': 'CR', 'LastName': 'Nahhas', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Peter N', 'Initials': 'PN', 'LastName': 'Chalmers', 'Affiliation': 'Department of Orthopaedic Surgery, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Parvizi', 'Affiliation': 'Department of Orthopaedic Surgery, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Sporer', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Keith R', 'Initials': 'KR', 'LastName': 'Berend', 'Affiliation': 'Joint Implant Surgeons, Inc., New Albany, Ohio.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Moric', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Antonia F', 'Initials': 'AF', 'LastName': 'Chen', 'Affiliation': ""Department of Orthopaedic Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Austin', 'Affiliation': 'Department of Orthopaedic Surgery, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania.'}, {'ForeName': 'Gregory K', 'Initials': 'GK', 'LastName': 'Deirmengian', 'Affiliation': 'Department of Orthopaedic Surgery, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Joint Implant Surgeons, Inc., New Albany, Ohio.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Della Valle', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.00915']
114,32319997,High Rates of Off-label Prescribing and the Urgent Need for a Randomized Clinical Trial.,,2020,,[],[],['High Rates of Off-label'],[],[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1096117', 'cui_str': 'Off label use'}]",,0.203738,,"[{'ForeName': 'Ann Marie', 'Initials': 'AM', 'LastName': 'Navar', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Associate Editor.'}]",JAMA cardiology,['10.1001/jamacardio.2020.0612']
115,32379269,Olanzapine for the Treatment of Advanced Cancer-Related Chronic Nausea and/or Vomiting: A Randomized Pilot Trial.,"Importance


Nausea and vomiting, unrelated to chemotherapy, can be substantial symptoms in patients with advanced cancer.
Objective


To evaluate the utility of olanzapine for treating chronic nausea/vomiting, unrelated to chemotherapy, in patients with advanced cancer.
Design, Setting, and Participants


This study is a double-line, placebo-controlled, randomized clinical trial conducted from July 2017 through April 2019, with analysis conducted in 2019. Eligible participants were outpatients with advanced cancer who had persistent nausea/vomiting without having had chemotherapy or radiotherapy in the prior 14 days. Chronic nausea was present for at least 1 week (worst daily nausea numeric rating scores needed to be greater than 3 on a 0-10 scale).
Interventions


Patients received olanzapine (5 mg) or a placebo, orally, daily for 7 days.
Main Outcomes and Measures


Patient-reported outcomes were used for study end points. Data were collected at baseline and daily for 7 more days. The primary study end point (the change in nausea numeric rating scores from baseline to the last treatment day) and the study hypothesis were both identified prior to data collection.
Results


A total of 30 patients (15 per arm) were enrolled; these included 16 women and 14 men who had a mean (range) age of 63 (39-79) years. Baseline median nausea scores, in all patients, were 9 out of 10 (range, 8-10). After 1 day and 1 week, the median nausea scores in the placebo arm were 9 out of 10 (range, 8-10) on both days, compared with the olanzapine arm scores of 2 out of 10 (range, 2-3) after day 1 and 1 out of 10 (range, 0-3) after 1 week. After 1 week of treatment, the reduction in nausea scores in the olanzapine arm was 8 points (95% CI, 7-8) higher than that of the placebo arm. The primary 2-sided end point P value was <.001. Correspondingly, patients in the olanzapine arm reported less emesis, less use of other antiemetic drugs, better appetite, less sedation, less fatigue, and better well-being. One patient, on the placebo, stopped treatment early owing to lack of perceived benefit. No patients receiving olanzapine reported excess sedation or any other adverse event.
Conclusions and Relevance


Olanzapine, at 5 mg/d, appeared to be effective in controlling nausea and emesis and in improving other symptoms and quality-of-life parameters in the study population.
Trial Registration


ClinicalTrials.gov Identifier: NCT03137121.",2020,"Correspondingly, patients in the olanzapine arm reported less emesis, less use of other antiemetic drugs, better appetite, less sedation, less fatigue, and better well-being.","['30 patients (15 per arm) were enrolled; these included 16 women and 14 men who had a mean (range) age of 63 (39-79) years', 'Eligible participants were outpatients with advanced cancer who had persistent nausea/vomiting without having had chemotherapy or radiotherapy in the prior 14 days', 'patients with advanced cancer', 'July 2017 through April 2019, with analysis conducted in 2019', 'Advanced Cancer-Related Chronic Nausea and/or Vomiting']","['olanzapine', 'Olanzapine', 'placebo']","['nausea and emesis', 'median nausea scores', 'Chronic nausea', 'excess sedation', 'Baseline median nausea scores', 'chronic nausea/vomiting', 'nausea scores', 'Nausea and vomiting', 'nausea numeric rating scores', 'emesis, less use of other antiemetic drugs, better appetite, less sedation, less fatigue, and better well-being']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C3654042', 'cui_str': 'Other antiemetics'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",30.0,0.258888,"Correspondingly, patients in the olanzapine arm reported less emesis, less use of other antiemetic drugs, better appetite, less sedation, less fatigue, and better well-being.","[{'ForeName': 'Rudolph M', 'Initials': 'RM', 'LastName': 'Navari', 'Affiliation': 'Comprehensive Cancer Center, University of Alabama at Birmingham.'}, {'ForeName': 'Cameron M', 'Initials': 'CM', 'LastName': 'Pywell', 'Affiliation': 'Comprehensive Cancer Center, University of Alabama at Birmingham.'}, {'ForeName': 'Jennifer G', 'Initials': 'JG', 'LastName': 'Le-Rademacher', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'White', 'Affiliation': 'Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Dodge', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Costantine', 'Initials': 'C', 'LastName': 'Albany', 'Affiliation': 'Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Loprinzi', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}]",JAMA oncology,['10.1001/jamaoncol.2020.1052']
116,32376872,"Correction: Ketamine metabolites, clinical response, and gamma power in a randomized, placebo-controlled, crossover trial for treatment-resistant major depression.",An amendment to this paper has been published and can be accessed via a link at the top of the paper.,2020,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,[],['placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.114074,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"[{'ForeName': 'Cristan A', 'Initials': 'CA', 'LastName': 'Farmer', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Gilbert', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Ruin', 'Initials': 'R', 'LastName': 'Moaddel', 'Affiliation': 'National Institute on Aging, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'Jomy', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Clinical Pharmacokinetics Research Unit, Pharmacy Department, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Adeojo', 'Affiliation': 'Clinical Pharmacokinetics Research Unit, Pharmacy Department, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Lovett', 'Affiliation': 'National Institute on Aging, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'Allison C', 'Initials': 'AC', 'LastName': 'Nugent', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bashkim', 'Initials': 'B', 'LastName': 'Kadriu', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Peixiong', 'Initials': 'P', 'LastName': 'Yuan', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Gould', 'Affiliation': 'Departments of Psychiatry, Pharmacology, and Anatomy and Neurobiology, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Lawrence T', 'Initials': 'LT', 'LastName': 'Park', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Zarate', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA. zaratec@mail.nih.gov.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0699-7']
117,32382745,A New Oral Testosterone Undecanoate Formulation Restores Testosterone to Normal Concentrations in Hypogonadal Men.,"CONTEXT


A novel formulation of oral testosterone (T) undecanoate (TU) was evaluated in a phase 3 clinical trial.
OBJECTIVE


Determine efficacy, short-term safety, and alignment of new oral TU formulation with current US approval standards for T replacement therapy.
DESIGN


Randomized, active-controlled, open-label study.
SETTING AND PATIENTS


Academic and private clinical practice sites; enrolled patients were clinically hypogonadal men 18 to 65 years old.
METHODS


Patients were randomized 3:1 to oral TU, as prescribed (JATENZO®; n = 166) or a topical T product once daily (Axiron®; n = 56) for 3 to 4 months. Dose titration was based on average T levels (Cavg) calculated from serial pharmacokinetic (PK) samples. T was assayed by liquid chromatography-mass spectrometry/mass spectrometry. Patients had 2 dose adjustment opportunities prior to final PK visit. Safety was assessed by standard clinical measures, including ambulatory blood pressure (BP).
RESULTS


87% of patients in both groups achieved mean T Cavg in the eugonadal range. Sodium fluoride-ethylenediamine tetra-acetate plasma T Cavg (mean ± standard deviation) for the oral TU group was 403 ± 128 ng/dL (~14 ± 4 nmol/L); serum T equivalent, ~489 ± 155 ng/dL (17 ± 5 nmol/L); and topical T, 391 ± 140 ng/dL (~14 ± 5 nmol/L). Modeling/simulation of T PK data demonstrated that dose titration based on a single blood sample 4 to 6 h after oral TU dose yielded efficacy (93%) equivalent to Cavg-based titration (87%). Safety profiles were similar in both groups, but oral TU was associated with a mean increase in systolic BP of 3 to 5 mm Hg.
CONCLUSION


A new oral TU formulation effectively restored T to mid-eugonadal levels in hypogonadal patients.",2020,"Safety profiles were similar in both groups, but oral TU was associated with a mean increase in systolic BP of 3-5 mm Hg.
CONCLUSION


","[' enrolled patients were clinically hypogonadal men 18-65 years old', 'Hypogonadal Men', 'Patients', 'hypogonadal patients', 'Academic and private clinical practice sites']","['Testosterone Undecanoate Formulation Restores Testosterone', 'oral testosterone (T) undecanoate (TU', 'topical T product QD (Axiron®']","['average T levels (Cavg) calculated from serial pharmacokinetic (PK) samples', 'Safety', 'ambulatory BP', 'Safety profiles', 'systolic BP', 'mean T Cavg']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0076195', 'cui_str': 'Testosterone undecanoate'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0359087', 'cui_str': 'Testosterone-containing product in oral dose form'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C2961759', 'cui_str': 'Axiron'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.046234,"Safety profiles were similar in both groups, but oral TU was associated with a mean increase in systolic BP of 3-5 mm Hg.
CONCLUSION


","[{'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Swerdloff', 'Affiliation': 'The Lundquist Institute and Harbor-UCLA Medical Center, Torrance, CA, US.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'The Lundquist Institute and Harbor-UCLA Medical Center, Torrance, CA, US.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'White', 'Affiliation': 'University of Connecticut School of Medicine, Farmington, CT, US.'}, {'ForeName': 'Jed', 'Initials': 'J', 'LastName': 'Kaminetsky', 'Affiliation': 'Manhattan Medical Research, New York, NY, US.'}, {'ForeName': 'Marc C', 'Initials': 'MC', 'LastName': 'Gittelman', 'Affiliation': 'UroMedix and South Florida Medical Research, Aventura, FL, US.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Longstreth', 'Affiliation': 'Longstreth and Associates, Mundelein, IL, US.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Dudley', 'Affiliation': 'Clarus Therapeutics Inc., Northbrook, IL, US.'}, {'ForeName': 'Theodore M', 'Initials': 'TM', 'LastName': 'Danoff', 'Affiliation': 'Clarus Therapeutics Inc., Northbrook, IL, US.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa238']
118,32375334,Circulating Levels of Muscle-Related Metabolites Increase in Response to a Daily Moderately High Dose of a Vitamin D3 Supplement in Women with Vitamin D Insufficiency-Secondary Analysis of a Randomized Placebo-Controlled Trial.,"Recently, we demonstrated negative effects of vitamin D supplementation on muscle strength and physical performance in women with vitamin D insufficiency. The underlying mechanism behind these findings remains unknown. In a secondary analysis of the randomized placebo-controlled trial designed to investigate cardiovascular and musculoskeletal health, we employed NMR-based metabolomics to assess the effect of a daily supplement of vitamin D3 (70 µg) or an identically administered placebo, during wintertime. We assessed the serum metabolome of 76 postmenopausal, otherwise healthy, women with vitamin D (25(OH)D) insufficiency (25(OH)D < 50 nmol/L), with mean levels of 25(OH)D of 33 ± 9 nmol/L. Compared to the placebo, vitamin D3 treatment significantly increased the levels of 25(OH)D (-5 vs. 59 nmol/L, respectively,  p  < 0.00001) and 1,25(OH) 2 D (-10 vs. 59 pmol/L, respectively,  p  < 0.00001), whereas parathyroid hormone (PTH) levels were reduced (0.3 vs. -0.7 pmol/L, respectively,  p  < 0.00001). Analysis of the serum metabolome revealed a significant increase of carnitine, choline, and urea and a tendency to increase for trimethylamine-N-oxide (TMAO) and urinary excretion of creatinine, without any effect on renal function. The increase in carnitine, choline, creatinine, and urea negatively correlated with muscle health and physical performance. Combined with previous clinical findings reporting negative effects of vitamin D on muscle strength and physical performance, this secondary analysis suggests a direct detrimental effect on skeletal muscle of moderately high daily doses of vitamin D supplements.",2020,"± 9 nmol/L. Compared to the placebo, vitamin D3 treatment significantly increased the levels of 25(OH)D (-5 vs. 59 nmol/L, respectively,  p  < 0.00001) and 1,25(OH) 2 D (-10 vs. 59 pmol/L, respectively,  p  < 0.00001), whereas parathyroid hormone (PTH) levels were reduced (0.3 vs. -0.7 pmol/L, respectively,  p  < 0.00001).","['76 postmenopausal, otherwise healthy, women with vitamin D (25(OH)D) insufficiency (25(OH)D < 50 nmol/L), with mean levels of 25(OH)D of 33', 'women with vitamin D insufficiency', 'Women with Vitamin D Insufficiency']","['Placebo', 'vitamin D supplements', 'Vitamin D3 Supplement', 'vitamin D3 (70 µg) or an identically administered placebo', 'placebo, vitamin D3', 'vitamin D', 'vitamin D supplementation', 'placebo']","['muscle strength and physical performance', 'parathyroid hormone (PTH) levels', 'renal function', 'levels of 25(OH)D', 'carnitine, choline, creatinine, and urea negatively correlated with muscle health and physical performance', 'carnitine, choline, and urea and a tendency to increase for trimethylamine-N-oxide (TMAO) and urinary excretion of creatinine']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency'}, {'cui': 'C0439282', 'cui_str': 'nmol/L'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007258', 'cui_str': 'Carnitine'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}]",,0.512143,"± 9 nmol/L. Compared to the placebo, vitamin D3 treatment significantly increased the levels of 25(OH)D (-5 vs. 59 nmol/L, respectively,  p  < 0.00001) and 1,25(OH) 2 D (-10 vs. 59 pmol/L, respectively,  p  < 0.00001), whereas parathyroid hormone (PTH) levels were reduced (0.3 vs. -0.7 pmol/L, respectively,  p  < 0.00001).","[{'ForeName': 'Lise Sofie', 'Initials': 'LS', 'LastName': 'Bislev', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, 8200 Aarhus N, Denmark.'}, {'ForeName': 'Ulrik Kræmer', 'Initials': 'UK', 'LastName': 'Sundekilde', 'Affiliation': 'Department of Food Science, Aarhus University, Agro Food Park 48, 8200 Aarhus N, Denmark.'}, {'ForeName': 'Ece', 'Initials': 'E', 'LastName': 'Kilic', 'Affiliation': 'Department of Food Science, Aarhus University, Agro Food Park 48, 8200 Aarhus N, Denmark.'}, {'ForeName': 'Trine Kastrup', 'Initials': 'TK', 'LastName': 'Dalsgaard', 'Affiliation': 'Department of Food Science, Aarhus University, Agro Food Park 48, 8200 Aarhus N, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Rejnmark', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, 8200 Aarhus N, Denmark.'}, {'ForeName': 'Hanne Christine', 'Initials': 'HC', 'LastName': 'Bertram', 'Affiliation': 'Department of Food Science, Aarhus University, Agro Food Park 48, 8200 Aarhus N, Denmark.'}]",Nutrients,['10.3390/nu12051310']
119,32379608,The Impact of Childhood Maltreatment on Long-Term Outcomes in Disorder-Specific vs. Nonspecific Psychotherapy for Chronic Depression.,"BACKGROUND


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


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


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


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


The presence of CM did not significantly moderate long-term treatment effects of CBASP compared to SP. When trauma subtypes were considered, CBASP was more effective than SP after one year in patients who retrospectively reported emotional abuse.",2020,"When trauma subtypes were considered, CBASP was more effective than SP after one year in patients who retrospectively reported emotional abuse.","['Disorder-Specific vs. Nonspecific Psychotherapy for Chronic Depression', 'patients with chronic depression and CM during acute treatment']","['CBT, IPT and Supportive Psychotherapy (SP', 'Psychotherapy (CBASP', 'CBASP', 'CBASP or SP']","['number of well weeks as measured by the Longitudinal Interval Follow-Up Evaluation Interview (LIFE', 'self- and clinician-rated depression symptoms']","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0581391', 'cui_str': 'Chronic depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0221295', 'cui_str': 'Supportive psychotherapy'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C1160858', 'cui_str': 'Behavior assessment'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",268.0,0.144678,"When trauma subtypes were considered, CBASP was more effective than SP after one year in patients who retrospectively reported emotional abuse.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bausch', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany. Electronic address: paul.bausch@gmx.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Fangmeier', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Meister', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Elsaeßer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Levente', 'Initials': 'L', 'LastName': 'Kriston', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Jan Philipp', 'Initials': 'JP', 'LastName': 'Klein', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Lübeck University, Lübeck, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Zobel', 'Affiliation': 'Psychology School at the Fresenius University of Applied Sciences Berlin, Berlin, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hautzinger', 'Affiliation': 'Department of Psychology, Clinical Psychology, and Psychotherapy, Eberhard Karls University Tübingen, Tübingen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Härter', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Schramm', 'Affiliation': 'Department of Psychology, Clinical Psychology, and Psychotherapy, Eberhard Karls University Tübingen, Tübingen, Germany.'}]",Journal of affective disorders,['10.1016/j.jad.2020.03.164']
120,32318745,"Comparative analysis of power, work and muscle activation during weight-stack and iso-inertial flywheel resistance exercise in young adults with cerebral palsy.","INTRODUCTION


The development of efficient resistance exercise protocols to counteract muscle dysfunction in cerebral palsy is warranted. Whether individuals with cerebral palsy are able to perform iso-inertial resistance (flywheel) exercise in a comparable manner to typically developed subjects has never been experimentally tested.
DESIGN


A comparative, controlled study.
SUBJECTS


Eight young ambulatory adults with cerebral palsy (mean age 19 years; Gross Motor Function Classification System (GMFCS) I-III) and 8 typically developed control subjects (mean age 21 years).
METHODS


Subjects performed acute bouts on the weight-stack and flywheel leg-press device, respectively. Range of motion, electromyography, power, work and muscle thickness (ultrasound) data were collected.
RESULTS


Subjects with cerebral palsy were able to produce a greater eccentric/concentric peak power ratio on the flywheel (p < 0.05 vs ratio in weight-stack), however absolute values were lower (p < 0.05 vs weight-stack). Typically developed subjects produced more power per mm of thigh muscle than the cerebral palsy group, independent of leg, device and action.
DISCUSSION


Subjects with cerebral palsy could not elicit the eccentric overload seen in typically developed subjects. Furthermore, peak power production per mm muscle was markedly reduced in both legs in subjects with cerebral palsy. In conclusion, this comparative study of weight-stack and flywheel exercise does not support the implementation of the current iso-inertial protocol for young adults with cerebral palsy.",2020,"Typically developed subjects produced more power per mm of thigh muscle than the cerebral palsy group, independent of leg, device and action.
","['Subjects performed acute bouts on the weight-stack and flywheel leg-press device, respectively', 'Subjects with cerebral palsy', 'young adults with cerebral palsy', 'subjects with cerebral palsy', 'individuals with cerebral palsy', 'Eight young ambulatory adults with cerebral palsy (mean age 19 years; Gross Motor Function Classification System (GMFCS) I-III) and 8 typically developed control subjects (mean age 21 years']","['resistance exercise protocols', 'weight-stack and flywheel exercise', 'power, work and muscle activation during weight-stack and iso-inertial flywheel resistance exercise']","['peak power production per mm muscle', 'Range of motion, electromyography, power, work and muscle thickness (ultrasound) data', 'power per mm of thigh muscle', 'eccentric/concentric peak power ratio']","[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0224416', 'cui_str': 'Skeletal muscle structure of thigh'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",8.0,0.012195,"Typically developed subjects produced more power per mm of thigh muscle than the cerebral palsy group, independent of leg, device and action.
","[{'ForeName': 'Ferdinand', 'Initials': 'F', 'LastName': 'von Walden', 'Affiliation': ""Women's and Children's health, Karolinska Institutet, , 17177 Stockholm, Sweden. ferdinand.von.walden@ki.se.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hjalmarsson', 'Affiliation': ''}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Reimeringer', 'Affiliation': ''}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Kvist', 'Affiliation': ''}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Raffalt', 'Affiliation': ''}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Pontén', 'Affiliation': ''}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Fernandez-Gonzalo', 'Affiliation': ''}]",Journal of rehabilitation medicine,['10.2340/16501977-2682']
121,32380239,Effects of Partial Sleep Deprivation on Braking Response of Drivers in Hazard Scenarios.,"This study aimed at modeling the Response Time (RT) and Total Braking Time (TBT) of drivers under Partial Sleep Deprivation (PSD). Fifty male participants drove the driving simulator in three experimental conditions: two test sessions and a baseline. The two test sessions were conducted after one and two nights of PSD (sleep = 4.25 ± 0.5 h), respectively. Sleep reduction was recorded using a wrist-worn Actiwatch. The baseline session was conducted after full rest (7-8 h sleep/day for a week). The order of test sessions and baseline was randomized. Each test included two hazard events: 1) pedestrians crossing a road and 2) parked vehicles merging into a roadway. Karolinska Sleepiness Scale (KSS) and Sleepiness Symptoms Questionnaire (SSQ) ratings were also recorded during each drive. Four separate models using parametric accelerated failure time (AFT) with Weibull distribution were developed for RT and TBT in the two events. The models were chosen with clustered heterogeneity to account for intra-group heterogeneity due to repeated measures across tests. In the case of pedestrians crossing event, RT increased by 10% in the first test session and no significant effect observed on RT in the second test session. The overall TBT reduced by 25% and 28% during the first and second PSD sessions, respectively. In the case of vehicle merging event, both response time and total braking time delayed by 44% and 17% respectively after PSD. Other factors such as age, experience, work-rest hours, KSS and SSQ rating, often exercising, approaching speed and braking force were also found significant in the analysis. The parametric AFT approach adopted in this study showed the change in 'response time' and 'total braking time' concerning the type of hazard scenario and partial sleep-deprivation.",2020,Four separate models using parametric accelerated failure time (AFT) with Weibull distribution were developed for RT and TBT in the two events.,"['Fifty male participants', 'Drivers in Hazard Scenarios']",['Partial Sleep Deprivation'],"['Sleep reduction', 'response time and total braking time delayed', 'pedestrians crossing a road and 2) parked vehicles merging into a roadway', 'Karolinska Sleepiness Scale (KSS) and Sleepiness Symptoms Questionnaire (SSQ) ratings', 'overall TBT', 'Response Time (RT) and Total Braking Time (TBT) of drivers under Partial Sleep Deprivation (PSD']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0337108', 'cui_str': 'Brake'}, {'cui': 'C0522486', 'cui_str': 'Delay time'}, {'cui': 'C0450063', 'cui_str': 'Pedestrian'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C0237771', 'cui_str': 'Parks, Recreational'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}]",50.0,0.023591,Four separate models using parametric accelerated failure time (AFT) with Weibull distribution were developed for RT and TBT in the two events.,"[{'ForeName': 'Kirti', 'Initials': 'K', 'LastName': 'Mahajan', 'Affiliation': 'Transportation Systems Engineering, Department of Civil Engineering, Indian Institute of Technology (IIT) Bombay, Powai, Mumbai 400 076, India.'}, {'ForeName': 'Nagendra R', 'Initials': 'NR', 'LastName': 'Velaga', 'Affiliation': 'Transportation Systems Engineering, Department of Civil Engineering, Indian Institute of Technology (IIT) Bombay, Powai, Mumbai 400 076, India. Electronic address: n.r.velaga@iitb.ac.in.'}]",Accident; analysis and prevention,['10.1016/j.aap.2020.105545']
122,32380260,Methodological and reporting issues in a randomised controlled trial: Comment on de la Fuente et al (2020).,,2020,,[],[],[],[],[],[],,0.0693986,,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': ""O'Halloran"", 'Affiliation': ""School of Nursing and Midwifery, Queen's University Belfast, Belfast BT9 7BL, United Kingdom. Electronic address: p.ohalloran@qub.ac.uk.""}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103585']
123,32383355,A mind-body intervention for stress reduction as an adjunct to an information session on stress management in university students.,"INTRODUCTION


This study describes the implementation of a mind-body intervention to reduce the perceived level of stress in a nonclinical group of university students. We used a novel approach including a single session of a mind-body technique known as the brain wave modulation (BWM) as an adjunct to a single information session on stress management.
METHODS


Three hundred and six students participated in the study. A quasi-experimental design was adopted: Students in the experimental group were exposed to an information session on stress management followed by a single session of the BWM, while the other students were exposed to the information session alone.
RESULTS


A 2 × 2 mixed factor analysis of variance demonstrated that the single session of the BWM was effective in reducing the perceived level of stress in the experimental group as compared to the control group.
CONCLUSION


The BWM is a very easy-to-learn technique that presents certain advantages over traditional mind-body methods.",2020,"A 2 × 2 mixed factor analysis of variance demonstrated that the single session of the BWM was effective in reducing the perceived level of stress in the experimental group as compared to the control group.
","['nonclinical group of university students', 'university students', 'Three hundred and six students participated in the study']",[],['perceived level of stress'],"[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]",306.0,0.0194834,"A 2 × 2 mixed factor analysis of variance demonstrated that the single session of the BWM was effective in reducing the perceived level of stress in the experimental group as compared to the control group.
","[{'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Cozzolino', 'Affiliation': 'Department of Humanities, Philosophy and Education, University of Salerno, Fisciano, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Girelli', 'Affiliation': 'Department of Humanities, Philosophy and Education, University of Salerno, Fisciano, Italy.'}, {'ForeName': 'Deborah R', 'Initials': 'DR', 'LastName': 'Vivo', 'Affiliation': 'Department of Humanities, Philosophy and Education, University of Salerno, Fisciano, Italy.'}, {'ForeName': 'Pierpaolo', 'Initials': 'P', 'LastName': 'Limone', 'Affiliation': 'Department of Humanities, Literature, Cultural Heritage, Education Sciences, University of Foggia, Foggia, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Celia', 'Affiliation': 'Department of Humanities, Literature, Cultural Heritage, Education Sciences, University of Foggia, Foggia, Italy.'}]",Brain and behavior,['10.1002/brb3.1651']
124,32380119,Exposure to harmful and potentially harmful constituents decreased in smokers switching to Carbon-Heated Tobacco Product.,"BACKGROUND


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


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


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


Switching from cigarettes to CHTP resulted in significantly reduced exposure to HPHCs and was associated with observed improvements in some biomarkers of effect representative of pathomechanistic pathways underlying the development of smoking-related diseases.",2020,"Exposure to nicotine was higher in the CHTP group at Day 5, but was similar between the two groups at Day90.","['smokers who switch to CHTP', 'adult healthy smokers, not willing to quit']","['CHTP', 'Carbon-Heated Tobacco Product (CHTP']","['white blood cell count, soluble intracellular adhesion molecule-1, and 11-dehydro-thromboxane B2 respectively indicative of reduced inflammation, endothelial dysfunction, and platelet activation', 'biomarkers of exposure (BoExp) to HPHCs, and to nicotine, urinary excretion of mutagenic constituents (Ames assay), CYP1A2 activity, biomarkers of effect, and safety', 'Urine mutagenicity and CYP1A2 activity']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0007009', 'cui_str': 'Carbon'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0600109', 'cui_str': 'Willing'}]","[{'cui': 'C0007009', 'cui_str': 'Carbon'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}]","[{'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0007578', 'cui_str': 'Cell Adhesion Molecules'}, {'cui': 'C0044728', 'cui_str': '11-dehydro-thromboxane B2'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0032173', 'cui_str': 'Platelet activation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0729650', 'cui_str': 'Constituents'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0066324', 'cui_str': 'methylamphotericin B'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0207509', 'cui_str': 'Cytochrome p450 CYP1A2 enzyme'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042036', 'cui_str': 'Urine'}]",,0.0196296,"Exposure to nicotine was higher in the CHTP group at Day 5, but was similar between the two groups at Day90.","[{'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Bosilkovska', 'Affiliation': 'Philip Morris International, Philip Morris Products, S.A., Quai Jeanrenaud 5, CH-2000, Neuchâtel, Switzerland. Electronic address: Marija.Bosilkovska@contracted.pmi.com.'}, {'ForeName': 'Cam Tuan', 'Initials': 'CT', 'LastName': 'Tran', 'Affiliation': 'Philip Morris International, Philip Morris Products, S.A., Quai Jeanrenaud 5, CH-2000, Neuchâtel, Switzerland.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'de La Bourdonnaye', 'Affiliation': 'Philip Morris International, Philip Morris Products, S.A., Quai Jeanrenaud 5, CH-2000, Neuchâtel, Switzerland.'}, {'ForeName': 'Brindusa', 'Initials': 'B', 'LastName': 'Taranu', 'Affiliation': 'Philip Morris International, Philip Morris Products, S.A., Quai Jeanrenaud 5, CH-2000, Neuchâtel, Switzerland.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Benzimra', 'Affiliation': 'Philip Morris International, Philip Morris Products, S.A., Quai Jeanrenaud 5, CH-2000, Neuchâtel, Switzerland.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Haziza', 'Affiliation': 'Philip Morris International, Philip Morris Products, S.A., Quai Jeanrenaud 5, CH-2000, Neuchâtel, Switzerland.'}]",Toxicology letters,['10.1016/j.toxlet.2020.04.013']
125,32382859,"Comparison of the Long-Term Results of Puncture, Aspiration, Injection and Re-aspiration (PAIR) and Catheterization Techniques for the Percutaneous Treatment of CE1 and CE3a Liver Hydatid Cysts: A Prospective Randomized Trial.","PURPOSE


To evaluate and compare the results of puncture, aspiration, injection and re-aspiration (PAIR) and catheterization techniques for treatment of CE1 and CE3a liver hydatid cysts according to World Health Organization classification.
MATERIALS AND METHODS


Forty patients (29 females) with 56 liver CE1and CE3a cysts were prospectively randomized and enrolled into 2 groups by sealed envelope method. Procedures were performed under general anesthesia. Several parameters including technical success (completing procedure steps), clinical success (lack of recurrence on follow-up), major and minor complications, long-term changes of cyst cavities and length of hospital stay were compared between two groups.
RESULTS


As in 2 patients with 3 cysts, PAIR technique had to be changed to catheterization technique due to technical reasons. The technical success rates were 91.9% and 100% for PAIR and catheterization groups, respectively. Volume decrease rates were 78.5% and 86.8% in PAIR and catheterization groups, with a mean follow-up of 78.1 and 71 months, respectively. There was no mortality, anaphylactic shock or intraabdominal dissemination. The rate of major complications such as abscess, cysto-biliary fistula and recurrence was 2.94% and 36.84% in PAIR and catheterization groups, respectively (p = 0.002). Median length of hospital stay was shorter in PAIR group (1 vs 4 days) (p = 0.015).
CONCLUSION


PAIR technique should be preferred to catheterization technique for treatment of liver CE1 and CE3a cysts due to lower rates of major complications and length of hospital stay. Catheterization technique should be employed when cysto-biliary fistula was evident.",2020,"Median length of hospital stay was shorter in PAIR group (1 vs 4 days) (p = 0.015).
","['CE1 and CE3a Liver Hydatid Cysts', 'Forty patients (29 females) with 56 liver CE1and CE3a cysts']","['puncture, aspiration, injection and re-aspiration (PAIR) and catheterization techniques', 'Puncture, Aspiration, Injection and Re-aspiration (PAIR) and Catheterization Techniques']","['rate of major complications such as abscess, cysto-biliary fistula and recurrence', 'mortality, anaphylactic shock or intraabdominal dissemination', 'Median length of hospital stay', 'Volume decrease rates', 'clinical success (lack of recurrence on follow-up), major and minor complications, long-term changes of cyst cavities and length of hospital stay', 'technical success', 'technical success rates']","[{'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0013502', 'cui_str': 'Echinococcosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0010709', 'cui_str': 'Cyst'}]","[{'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}, {'cui': 'C0005417', 'cui_str': 'Fistula of bile duct'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0002792', 'cui_str': 'Anaphylaxis'}, {'cui': 'C0230168', 'cui_str': 'Abdominopelvic cavity structure'}, {'cui': 'C0205221', 'cui_str': 'Disseminated'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0010709', 'cui_str': 'Cyst'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0449851', 'cui_str': 'Technique'}]",2.0,0.0334107,"Median length of hospital stay was shorter in PAIR group (1 vs 4 days) (p = 0.015).
","[{'ForeName': 'Okan', 'Initials': 'O', 'LastName': 'Akhan', 'Affiliation': 'Department of Radiology, Hacettepe University School of Medicine, 06100, Ankara, Turkey. akhano@tr.net.'}, {'ForeName': 'Erhan', 'Initials': 'E', 'LastName': 'Erdoğan', 'Affiliation': 'Department of Radiology, Eskisehir Yunus Emre State Hospital, 26190, Eskişehir, Turkey.'}, {'ForeName': 'Turkmen Turan', 'Initials': 'TT', 'LastName': 'Ciftci', 'Affiliation': 'Department of Radiology, Hacettepe University School of Medicine, 06100, Ankara, Turkey.'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Unal', 'Affiliation': 'Department of Radiology, Hacettepe University School of Medicine, 06100, Ankara, Turkey.'}, {'ForeName': 'Ergun', 'Initials': 'E', 'LastName': 'Karaağaoğlu', 'Affiliation': 'Department of Biostatistics, Hacettepe University, 06100, Ankara, Turkey.'}, {'ForeName': 'Devrim', 'Initials': 'D', 'LastName': 'Akinci', 'Affiliation': 'Department of Radiology, Hacettepe University School of Medicine, 06100, Ankara, Turkey.'}]",Cardiovascular and interventional radiology,['10.1007/s00270-020-02477-7']
126,32380746,Consumption of Goat Cheese Naturally Rich in Omega-3 and Conjugated Linoleic Acid Improves the Cardiovascular and Inflammatory Biomarkers of Overweight and Obese Subjects: A Randomized Controlled Trial.,"This study examines the value of a goat cheese naturally enriched in polyunsaturated fatty acids (PUFA) (n-3 PUFA and conjugated linolenic acid (CLA)) as means of improving cardiovascular and inflammatory health. Sixty-eight overweight and obese subjects (BMI ≥ 27 and <40 kg/m 2 ), with at least two risk factors for cardiovascular disease (CVD) in a lipid panel blood tests, participated in a randomized, placebo-controlled, double-blind, parallel designed study. The subjects consumed for 12 weeks: (1) 60 g/d control goat cheese and (2) 60 g/d goat cheese naturally enriched in n-3 PUFA and CLA. Diet and physical activity were assessed. Anthropometric and dual-energy X-ray absorptiometry (DXA) tests were performed. Blood samples were collected at the beginning and at the end of the study period. Changes in health status, lifestyle and dietary habits, and daily compliance were recorded. The consumption of a PUFA-enriched goat cheese significantly increased plasma high-density lipoprotein (HDL)-cholesterol, as well as in apolipoprotein B, and it significantly decreased high-sensitivity C-reactive protein concentrations compared to the control goat cheese ( p  < 0.05). The significant improvement of the plasma lipid profile and inflammatory status of people with risk for CVD due to the consumption of PUFA-enriched cheese suggests a potential role of this dairy product as an alternative to develop high nutritional value food in a balanced diet comprising regular exercise.",2020,"The consumption of a PUFA-enriched goat cheese significantly increased plasma high-density lipoprotein (HDL)-cholesterol, as well as in apolipoprotein B, and it significantly decreased high-sensitivity C-reactive protein concentrations compared to the control goat cheese ( p  < 0.05).","['Overweight and Obese Subjects', 'Sixty-eight overweight and obese subjects (BMI ≥ 27 and <40 kg/m 2 ), with at least two risk factors for cardiovascular disease (CVD) in a lipid panel blood tests']","['Cheese', 'goat cheese naturally enriched in polyunsaturated fatty acids (PUFA) (n-3 PUFA and conjugated linolenic acid (CLA', 'Omega-3 and Conjugated Linoleic Acid', 'placebo']","['n-3 PUFA and CLA', 'Diet and physical activity', 'plasma high-density lipoprotein (HDL)-cholesterol', 'Blood samples', 'health status, lifestyle and dietary habits, and daily compliance', 'high-sensitivity C-reactive protein concentrations', 'Consumption of Goat', 'Anthropometric and dual-energy X-ray absorptiometry (DXA) tests', 'plasma lipid profile and inflammatory status']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0023767', 'cui_str': 'Lipid A'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}]","[{'cui': 'C0007968', 'cui_str': 'Cheese'}, {'cui': 'C0018019', 'cui_str': 'Capra hircus'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0023752', 'cui_str': 'Linolenic Acids'}, {'cui': 'C0050156', 'cui_str': '9,11-linoleic acid'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0050156', 'cui_str': '9,11-linoleic acid'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0018019', 'cui_str': 'Capra hircus'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",68.0,0.0440996,"The consumption of a PUFA-enriched goat cheese significantly increased plasma high-density lipoprotein (HDL)-cholesterol, as well as in apolipoprotein B, and it significantly decreased high-sensitivity C-reactive protein concentrations compared to the control goat cheese ( p  < 0.05).","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Santurino', 'Affiliation': 'Nutrition Research Group, Hospital La Paz Institute for Health Research (IdiPAZ), 28046 Madrid, Spain.'}, {'ForeName': 'Bricia', 'Initials': 'B', 'LastName': 'López-Plaza', 'Affiliation': 'Nutrition Research Group, Hospital La Paz Institute for Health Research (IdiPAZ), 28046 Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Fontecha', 'Affiliation': 'Food Lipid Biomarkers and Health Group, Institute of Food Science Research (CIAL, CSIC), Campus of Autonomous University of Madrid, 28049 Madrid, Spain.'}, {'ForeName': 'María V', 'Initials': 'MV', 'LastName': 'Calvo', 'Affiliation': 'Food Lipid Biomarkers and Health Group, Institute of Food Science Research (CIAL, CSIC), Campus of Autonomous University of Madrid, 28049 Madrid, Spain.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Bermejo', 'Affiliation': 'Nutrition Research Group, Hospital La Paz Institute for Health Research (IdiPAZ), 28046 Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gómez-Andrés', 'Affiliation': 'Department of Anatomy, Histology and Neuroscience, School of Medicine, Autonomous University of Madrid, 28049 Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Gómez-Candela', 'Affiliation': 'Nutrition Research Group, Hospital La Paz Institute for Health Research (IdiPAZ), 28046 Madrid, Spain.'}]",Nutrients,['10.3390/nu12051315']
127,32381418,Mineral Trioxide Aggregate Could Have a Better Success Rate Than Calcium Hydroxide for Partial Pulpotomy of Symptomatic Mature Permanent Molars.,"ARTICLE TITLE AND BIBLIOGRAPHIC INFORMATION


Partial Pulpotomy in Mature Permanent Teeth with Clinical Signs Indicative of Irreversible Pulpitis: A Randomized Clinical Trial. Taha NA, Khazali MA. J Endod 2017;43(9):1417-21.
SOURCE OF FUNDING


Information not available.
TYPE OF STUDY/DESIGN


Randomized clinical trial.",2020,"J Endod 2017;43(9):1417-21.
",['Mature Permanent Teeth with Clinical Signs Indicative of Irreversible Pulpitis'],['Calcium Hydroxide'],[],"[{'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0348070', 'cui_str': 'Structure of permanent tooth'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}]","[{'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}]",[],,0.0959954,"J Endod 2017;43(9):1417-21.
","[{'ForeName': 'Eman', 'Initials': 'E', 'LastName': 'Bakhurji', 'Affiliation': ''}]",The journal of evidence-based dental practice,['10.1016/j.jebdp.2019.101341']
128,32381556,Effect of a Digital Health Intervention on Decreasing Barriers and Increasing Facilitators for Colorectal Cancer Screening in Vulnerable Patients.,"BACKGROUND


Colorectal cancer is the second leading cause of cancer-related death in the United States, in part, because one third of Americans fail to get screened. In a prior randomized controlled trial, we found that an iPad patient decision aid called Mobile Patient Technology for Health-CRC (mPATH-CRC) doubled the proportion of patients who completed colorectal cancer screening.
METHODS


All data for the current analysis were collected as part of a randomized controlled trial to determine the impact of mPATH-CRC on receipt of colorectal cancer screening within 24 weeks. Participants were enrolled from six community-based primary care practices between June 2014 and May 2016 and randomized to either usual care or mPATH-CRC. Six potential mediators of the intervention effect on screening were considered. The Iacobucci method was used to assess the significance of the mediation.
RESULTS


A total of 408 patients had complete data for all potential mediators. Overall, the potential mediators accounted for approximately three fourths (76.3%) of the effect of the program on screening completion. Perceived benefits, self-efficacy, ability to state a screening decision, and patient-provider discussion were statistically significant mediators. Patient-provider discussion accounted for the largest proportion of the effect of mPATH-CRC (70.7%).
CONCLUSIONS


mPATH-CRC increased completion of colorectal cancer screening by affecting patient-level and system-level mediators. However, the most powerful mediator was the occurrence of a patient-provider discussion about screening. Digital interventions like mPATH-CRC are an important adjunct to the patient-provider encounter.
IMPACT


Understanding the factors that mediated mPATH-CRC's success is paramount to developing other effective interventions.",2020,"Perceived benefits, self-efficacy, ability to state a screening decision, and patient/provider discussion were statistically significant mediators.","['Colorectal cancer (CRC', 'Participants were enrolled from 6 community-based primary care practices between June 2014 and May 2016 and randomized to either', '408 patients had complete data for all potential mediators', 'Colorectal Cancer Screening in Vulnerable Patients', 'iPad patient decision aid called Mobile Patient Technology for Health-CRC (mPATH-CRC) doubled the proportion of patients who completed CRC screening']","['usual care or mPATH-CRC', 'Digital Health Intervention']","['Perceived benefits, self-efficacy, ability to state a screening decision, and patient/provider discussion', 'completion of CRC screening']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4517769', 'cui_str': '408'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]",408.0,0.0654856,"Perceived benefits, self-efficacy, ability to state a screening decision, and patient/provider discussion were statistically significant mediators.","[{'ForeName': 'Nancy M', 'Initials': 'NM', 'LastName': 'Denizard-Thompson', 'Affiliation': 'Internal Medicine, Wake Forest University School of Medicine, Winston-Salem, North Carolina. ndenizar@wakehealth.edu.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Miller', 'Affiliation': 'Internal Medicine, Wake Forest University School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Snavely', 'Affiliation': 'Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Spangler', 'Affiliation': 'Department of Family and Community Medicine, Wake Forest School of Medicine, Winston Salem, North Carolina.'}, {'ForeName': 'L Doug', 'Initials': 'LD', 'LastName': 'Case', 'Affiliation': 'Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Weaver', 'Affiliation': 'Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-19-1199']
129,32381562,Maintenance of clinical remission in early axial spondyloarthritis following certolizumab pegol dose reduction.,"BACKGROUND


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


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


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


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


NCT02505542, ClinicalTrials.gov.",2020,"At Week 48, 43.9% (323/736) patients achieved sustained remission, of whom 313 were randomised to CZP full maintenance dose, CZP reduced maintenance dose or placebo.","['ASDAS) <1.3 at Weeks 32/36 and 48', 'patients with early axSpA.\nMETHODS', 'patients with axial spondyloarthritis (axSpA', 'adults with early active axSpA (radiographic or non-radiographic']","['CZP 200\u2009mg every 2 weeks (Q2W', 'CZP 200\u2009mg every 4 weeks (Q4W; reduced maintenance dose) or placebo', 'CZP 200\u2009mg Q2W', 'placebo']","['remaining flare-free (flare: ASDAS', 'sustained remission (Ankylosing Spondylitis Disease Activity Score', 'sustained remission', 'flare-free']","[{'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}]","[{'cui': 'C4026841', 'cui_str': 'certolizumab pegol 200 MG'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C3714445', 'cui_str': 'Maintenance dose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}]",,0.666024,"At Week 48, 43.9% (323/736) patients achieved sustained remission, of whom 313 were randomised to CZP full maintenance dose, CZP reduced maintenance dose or placebo.","[{'ForeName': 'Robert Bm', 'Initials': 'RB', 'LastName': 'Landewé', 'Affiliation': 'Amsterdam Rheumatology & Clinical Immunology Center, Amsterdam, The Netherlands landewe@rlandewe.nl.'}, {'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'Depertment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Dougados', 'Affiliation': 'Hopital Cochin, Rheumatology, Université Paris Descartes, Paris, France.'}, {'ForeName': 'Xenofon', 'Initials': 'X', 'LastName': 'Baraliakos', 'Affiliation': 'Rheumazentrum Ruhrgebiet, Ruhr University Bochum, Bochum, Herne, Germany.'}, {'ForeName': 'Filip E', 'Initials': 'FE', 'LastName': 'Van den Bosch', 'Affiliation': 'Department of Internal Medicine and Pediatrics, VIB Center for Inflammation Research, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Gaffney', 'Affiliation': 'Rheumatology Department, Norfolk and Norwich University Hospital NHS Foundation Trust, Norwich, UK.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bauer', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Hoepken', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany.'}, {'ForeName': 'Owen R', 'Initials': 'OR', 'LastName': 'Davies', 'Affiliation': 'UCB Pharma, Slough, UK.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'de Peyrecave', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Thomas', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany.'}, {'ForeName': 'Lianne', 'Initials': 'L', 'LastName': 'Gensler', 'Affiliation': 'University of California San Francisco, San Francisco, California, USA.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216839']
130,32383748,Effect of Zinc Supplementation vs Placebo on Mortality Risk and HIV Disease Progression Among HIV-Positive Adults With Heavy Alcohol Use: A Randomized Clinical Trial.,"Importance


Zinc supplementation can reduce alcohol-related microbial translocation and inflammation.
Objective


To assess whether zinc supplementation reduces markers of mortality and risk of cardiovascular disease, reduces levels of inflammation and microbial translocation, and slows HIV disease progression in people with heavy alcohol use who are living with HIV/AIDS.
Design, Setting, and Participants


This study is a double-blinded placebo-controlled randomized clinical trial of zinc supplementation among participants recruited from 2013 to 2015. Participants were recruited from HIV and addiction clinical and nonclinical care sites in St Petersburg, Russia. Participants were adults (aged 18-70 years) with documented HIV infection who were antiretroviral therapy-naive at baseline and had past 30-day heavy alcohol consumption. Data analysis was performed from February 2017 to February 2020.
Intervention


Pharmacy-grade zinc gluconate supplementation (15 mg for men and 12 mg for women, taken daily by mouth for 18 months) was compared with a placebo.
Main Outcomes and Measures


The primary outcome was mortality risk measured as a change in Veterans Aging Cohort Study (VACS) Index score between baseline and 18 months. The VACS Index scores range from 0 to 164, with higher scores indicating higher mortality risk. Secondary outcomes were change in CD4 cell count between baseline and 18 months, the assessment of cardiovascular disease risk (Reynolds Risk Score, which ranges from 0% to 100%, with higher scores indicating higher risk), and changes in inflammatory or microbial translocation biomarkers at 18 months. Adjusted linear regression analyses were performed.
Results


A total of 254 participants (184 men [72%]; mean [SD] age, 34 [6] years) were enrolled in the trial; 126 were randomized to receive zinc, and 128 were randomized to receive placebo. Participants had high CD4 cell counts (mean [SD], 521 [292] cells/mm3), and 188 (74%) reported heavy drinking in the past week. In the main analyses, zinc supplementation did not affect changes in the VACS Index score at 18 months (change for zinc, mean [SD], 0.49 [14.6]; median [interquartile range], 0.0 [-7.0 to 6.0]; change for placebo, mean [SD], 5.5 [17.2]; median [interquartile range], 6.0 [-6.0 to 14.0]; adjusted mean difference [AMD], -4.68; 95% CI, -9.62 to 0.25; P = .06) or any secondary outcomes, including change in CD4 cell count (AMD, 41.8 cells/mm3; 95% CI, -20.3 to 103.8 cells/mm3; P = .19), Reynolds Risk Score (AMD, -0.014; 95% CI, -0.167 to 0.139; P = .85), interleukin-6 level (AMD, -0.13 pg/mL; 95% CI, -0.38 to 0.11 pg/mL; P = .30), dimerized plasmin fragment D level (AMD, -0.21 μg/mL fibrinogen equivalent units; 95% CI, -0.48 to 0.07 μg/mL fibrinogen equivalent units; P = .14), soluble CD14 level (AMD, -38.01 ng/mL; 95% CI, -166.90 to 90.88 ng/mL; P = .56), intestinal fatty acid binding protein level (AMD, 0.08 pg/mL; 95% CI, -0.07 to 0.22 pg/mL; P = .32), and lipopolysaccharide binding protein level (AMD, -0.09 ng/mL; 95% CI, -0.23 to 0.06 ng/mL; P = .24). In the per-protocol analyses, zinc supplementation statistically significantly affected changes in the VACS Index score at 18 months (AMD, -7.49; 95% CI, -13.74 to -1.23; P = .02); however, the adherence rate to zinc supplementation was 51%.
Conclusions and Relevance


Zinc supplementation did not reduce mortality risk, CD4 cell counts, cardiovascular disease risk, and levels of inflammation or microbial translocation in people with heavy alcohol use who are living with HIV/AIDS. Zinc supplementation did not change the VACS Index score but may have been limited by low adherence.
Trial Registration


ClinicalTrials.gov Identifier: NCT01934803.",2020,"In the per-protocol analyses, zinc supplementation statistically significantly affected changes in the VACS Index score at 18 months (AMD, -7.49; 95% CI, -13.74 to -1.23; P = .02); however, the adherence rate to zinc supplementation was 51%.
","['participants recruited from 2013 to 2015', 'Participants were adults (aged 18-70 years) with documented HIV infection who were antiretroviral therapy-naive at baseline and had past 30-day heavy alcohol consumption', 'HIV-Positive Adults With Heavy Alcohol Use', 'Participants were recruited from HIV and addiction clinical and nonclinical care sites in St Petersburg, Russia', 'A total of 254 participants (184 men [72%]; mean [SD] age, 34 [6] years) were enrolled in the trial; 126', 'people with heavy alcohol use who are living with HIV/AIDS']","['Zinc supplementation', 'zinc supplementation', 'Zinc Supplementation vs Placebo', 'Intervention\n\n\nPharmacy-grade zinc gluconate supplementation', 'placebo']","['Mortality Risk and HIV Disease Progression', 'mortality risk', 'cardiovascular disease risk (Reynolds Risk Score', 'change in CD4 cell count', 'high CD4 cell counts', 'VACS Index score', 'changes in inflammatory or microbial translocation biomarkers', 'soluble CD14 level', 'mortality risk measured as a change in Veterans Aging Cohort Study (VACS', 'VACS Index scores range', 'interleukin-6 level', 'adherence rate to zinc supplementation', 'lipopolysaccharide binding protein level', 'mortality and risk of cardiovascular disease, reduces levels of inflammation and microbial translocation, and slows HIV disease progression', 'Index score', 'intestinal fatty acid binding protein level', 'heavy drinking', 'dimerized plasmin fragment D level', 'mortality risk, CD4 cell counts, cardiovascular disease risk, and levels of inflammation or microbial translocation', 'Reynolds Risk Score']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0337950', 'cui_str': 'Site of care'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]","[{'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0149381', 'cui_str': 'Zinc Gluconate'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1141957', 'cui_str': 'HIV disease progression'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040715', 'cui_str': 'Chromosomal translocation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0108768', 'cui_str': 'Lymphocyte antigen CD14'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0065054', 'cui_str': 'lipopolysaccharide-binding protein'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0163314', 'cui_str': 'Intestinal Fatty Acid-Binding Protein'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0016016', 'cui_str': 'Plasmin'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}]",126.0,0.736847,"In the per-protocol analyses, zinc supplementation statistically significantly affected changes in the VACS Index score at 18 months (AMD, -7.49; 95% CI, -13.74 to -1.23; P = .02); however, the adherence rate to zinc supplementation was 51%.
","[{'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Freiberg', 'Affiliation': 'Vanderbilt Center for Clinical Cardiovascular Trials Evaluation (V-C3REATE), Cardiovascular Division, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Debbie M', 'Initials': 'DM', 'LastName': 'Cheng', 'Affiliation': 'Department of Biostatistics, Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Gnatienko', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Blokhina', 'Affiliation': 'First Pavlov State Medical University of St Petersburg, St Petersburg, Russian Federation.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Coleman', 'Affiliation': 'Biostatistics and Epidemiology Data Analytics Center (BEDAC), Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Margaret F', 'Initials': 'MF', 'LastName': 'Doyle', 'Affiliation': 'Larner College of Medicine, Department of Pathology and Laboratory Medicine, The University of Vermont, Colchester.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Yaroslavtseva', 'Affiliation': 'First Pavlov State Medical University of St Petersburg, St Petersburg, Russian Federation.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Bridden', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Kaku', 'Initials': 'K', 'LastName': 'So-Armah', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Tracy', 'Affiliation': 'Larner College of Medicine, Department of Pathology and Laboratory Medicine, The University of Vermont, Colchester.'}, {'ForeName': 'Kendall', 'Initials': 'K', 'LastName': 'Bryant', 'Affiliation': 'HIV/AIDS Research, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Lioznov', 'Affiliation': 'First Pavlov State Medical University of St Petersburg, St Petersburg, Russian Federation.'}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Krupitsky', 'Affiliation': 'First Pavlov State Medical University of St Petersburg, St Petersburg, Russian Federation.'}, {'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Samet', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Boston Medical Center, Boston, Massachusetts.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.4330']
131,32380138,Reduced tactile acuity in chronic low back pain is linked with structural neuroplasticity in primary somatosensory cortex and is modulated by acupuncture therapy.,"Prior studies have shown that patients suffering from chronic Low Back Pain (cLBP) have impaired somatosensory processing including reduced tactile acuity, i.e. reduced ability to resolve fine spatial details with the perception of touch. The central mechanism(s) underlying reduced tactile acuity are unknown but may include changes in specific brain circuitries (e.g. neuroplasticity in the primary somatosensory cortex, S1). Furthermore, little is known about the linkage between changes in tactile acuity and the amelioration of cLBP by somatically-directed therapeutic interventions, such as acupuncture. In this longitudinal neuroimaging study, we evaluated healthy control adults (HC, N ​= ​50) and a large sample of cLBP patients (N ​= ​102) with structural brain imaging (T1-weighted MRI for Voxel-Based Morphometry, VBM; Diffusion Tensor Imaging, DTI) and tactile acuity testing using two-point discrimination threshold (2PDT) over the lower back (site of pain) and finger (control) locations. Patients were evaluated at baseline and following a 4-week course of acupuncture, with patients randomized to either verum acupuncture, two different forms of sham acupuncture (designed with or without somatosensory afference), or no-intervention usual care control. At baseline, cLBP patients demonstrated reduced acuity (greater 2PDT, P ​= ​0.01) over the low back, but not finger (P ​= ​0.29) locations compared to HC, suggesting that chronic pain affects tactile acuity specifically at body regions encoding the experience of clinical pain. At baseline, Gray Matter Volume (GMV) was elevated and Fractional Anisotropy (FA) was reduced, respectively, in the S1-back region of cLBP patients compared to controls (P ​< ​0.05). GMV in cLBP correlated with greater 2PDT-back scores (ρ ​= ​0.27, P ​= ​0.02). Following verum acupuncture, tactile acuity over the back was improved (reduced 2PDT) and greater improvements were associated with reduced S1-back GMV (ρ ​= ​0.52, P ​= ​0.03) and increased S1-back adjacent white matter FA (ρ ​= ​-0.56, P ​= ​0.01). These associations were not seen for non-verum control interventions. Thus, S1 neuroplasticity in cLBP is linked with deficits in tactile acuity and, following acupuncture therapy, may represent early mechanistic changes in somatosensory processing that track with improved tactile acuity.",2020,"At baseline, Gray Matter Volume (GMV) was elevated and Fractional Anisotropy (FA) was reduced, respectively, in the S1-back region of cLBP patients compared to controls (P<0.05).","['patients suffering from chronic Low Back Pain (cLBP', 'healthy control adults (HC, N=50) and a large sample of cLBP patients (N=102) with']","['acupuncture', 'structural brain imaging (T1-weighted MRI for Voxel Based Morphometry, VBM; Diffusion Tensor Imaging, DTI) and tactile acuity testing using two-point discrimination threshold (2PDT', 'verum acupuncture', 'sham acupuncture (designed with or without somatosensory afference), or no-intervention usual care control']","['tactile acuity', 'S1-back adjacent white matter FA', '2PDT-back scores', 'Fractional Anisotropy (FA', 'tactile acuity over the back was improved (reduced 2PDT', 'reduced S1-back GMV', 'reduced acuity', 'Gray Matter Volume (GMV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0203860', 'cui_str': 'Imaging of brain'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C4523852', 'cui_str': 'Voxel-based morphometry'}, {'cui': 'C0078140', 'cui_str': 'VBM protocol'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",102.0,0.102659,"At baseline, Gray Matter Volume (GMV) was elevated and Fractional Anisotropy (FA) was reduced, respectively, in the S1-back region of cLBP patients compared to controls (P<0.05).","[{'ForeName': 'Hyungjun', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA; Division of Clinical Medicine, Korea Institute of Oriental Medicine, Daejeon, 34054, South Korea.'}, {'ForeName': 'Ishtiaq', 'Initials': 'I', 'LastName': 'Mawla', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Jeungchan', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Gerber', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Walker', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Jieun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA; Division of Clinical Medicine, Korea Institute of Oriental Medicine, Daejeon, 34054, South Korea.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ortiz', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Suk-Tak', 'Initials': 'ST', 'LastName': 'Chan', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Marco L', 'Initials': 'ML', 'LastName': 'Loggia', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Ajay D', 'Initials': 'AD', 'LastName': 'Wasan', 'Affiliation': 'Department of Anesthesiology, Center for Pain Research, University of Pittsburgh, Pittsburgh, PA, 15261, USA.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Edwards', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, 02115, USA.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Kong', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA; Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, 02215, USA.'}, {'ForeName': 'Ted J', 'Initials': 'TJ', 'LastName': 'Kaptchuk', 'Affiliation': 'Program in Placebo Studies & Therapeutic Encounter (PiPS), Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, 02115, USA.'}, {'ForeName': 'Randy L', 'Initials': 'RL', 'LastName': 'Gollub', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA; Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, 02215, USA.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Rosen', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Vitaly', 'Initials': 'V', 'LastName': 'Napadow', 'Affiliation': ""Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA; Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, 02115, USA. Electronic address: vitaly@mgh.harvard.edu.""}]",NeuroImage,['10.1016/j.neuroimage.2020.116899']
132,32384495,"A simple, efficient, and safe way of finding recurrent laryngeal nerve beneficial for PTC patients.","BACKGROUND


More surgeons have known the importance of parathyroid grand and recurrent laryngeal nerve protection in the surgery, but there is still plenty of scope to improve the surgical techniques. This study aims at investigating whether the improved method of finding recurrent laryngeal nerve (RLN) can protect parathyroid grand and RLN.
METHODS


One hundred fifty-eight patients were enrolled and divided randomly into the test and control group according to different methods of finding RLN in the surgery. In the experimental group the author could quickly find the laryngeal recurrent nerve in the lower part of the neck and separate along the surface of the recurrent laryngeal nerve to the point where the recurrent laryngeal nerve gets into the larynx close to the thyroid gland named lateral approach, while in the control group the author severed the middle and lower thyroid vein and raised the lower thyroid pole to look for the RLN near the trachea by the blunt separation.
RESULTS


The author identified 152 and 159 parathyroid glands in the test and control group, respectively and there were a lower ratio of auto-transplantation and less operative time in the test group compared with that in the control group. The author also found that the parathyroid hormone level (1 day and 2 months) in the test group was higher than that in the control group. There were no differences in metastatic LN and recurrent laryngeal nerve palsy in the 2 groups.
CONCLUSION


The improved method of finding RLN is a simple, efficient and safe way, and easy to implement.",2020,"There were no differences in metastatic LN and recurrent laryngeal nerve palsy in the 2 groups.
",['One hundred fifty-eight patients'],[],"['metastatic LN and recurrent laryngeal nerve palsy', 'parathyroid hormone level', 'lower ratio of auto-transplantation and less operative time']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0542142', 'cui_str': 'Vagus nerve laryngeal paralysis'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}]",158.0,0.0184314,"There were no differences in metastatic LN and recurrent laryngeal nerve palsy in the 2 groups.
","[{'ForeName': 'Shouyi', 'Initials': 'S', 'LastName': 'Yan', 'Affiliation': 'Department of Thyroid and Vascular Surgery.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Xie', 'Affiliation': 'Department of Thyroid and Vascular Surgery.'}, {'ForeName': 'Wenxin', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Thyroid and Vascular Surgery.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Thyroid and Vascular Surgery.'}, {'ForeName': 'Liyong', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Thyroid and Vascular Surgery.'}]",Medicine,['10.1097/MD.0000000000020138']
133,32384055,"Usability, Acceptability, and Effectiveness of Web-Based Conversational Agents to Facilitate Problem Solving in Older Adults: Controlled Study.","BACKGROUND


The usability and effectiveness of conversational agents (chatbots) that deliver psychological therapies is under-researched.
OBJECTIVE


This study aimed to compare the system usability, acceptability, and effectiveness in older adults of 2 Web-based conversational agents that differ in theoretical orientation and approach.
METHODS


In a randomized study, 112 older adults were allocated to 1 of the following 2 fully automated interventions: Manage Your Life Online (MYLO; ie, a chatbot that mimics a therapist using a method of levels approach) and ELIZA (a chatbot that mimics a therapist using a humanistic counseling approach). The primary outcome was problem distress and resolution, with secondary outcome measures of system usability and clinical outcome.
RESULTS


MYLO participants spent significantly longer interacting with the conversational agent. Posthoc tests indicated that MYLO participants had significantly lower problem distress at follow-up. There were no differences between MYLO and ELIZA in terms of problem resolution. MYLO was rated as significantly more helpful and likely to be used again. System usability of both the conversational agents was associated with helpfulness of the agents and the willingness of the participants to reuse. Adherence was high. A total of 12% (7/59) of the MYLO group did not carry out their conversation with the chatbot.
CONCLUSIONS


Controlled studies of chatbots need to be conducted in clinical populations across different age groups. The potential integration of chatbots into psychological care in routine services is discussed.",2020,System usability of both the conversational agents was associated with helpfulness of the agents and the willingness of the participants to reuse.,"['112 older adults', 'Older Adults', 'older adults']","['Web-Based Conversational Agents', 'ELIZA', 'conversational agents (chatbots']","['problem distress', 'Usability, Acceptability, and Effectiveness', 'system usability, acceptability, and effectiveness', 'Manage Your Life Online (MYLO', 'problem distress and resolution, with secondary outcome measures of system usability and clinical outcome']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",112.0,0.098404,System usability of both the conversational agents was associated with helpfulness of the agents and the willingness of the participants to reuse.,"[{'ForeName': 'Matthew Russell', 'Initials': 'MR', 'LastName': 'Bennion', 'Affiliation': 'Department of Psychology, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Gillian E', 'Initials': 'GE', 'LastName': 'Hardy', 'Affiliation': 'Department of Psychology, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Roger K', 'Initials': 'RK', 'LastName': 'Moore', 'Affiliation': 'Department of Computer Science, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Kellett', 'Affiliation': 'Department of Psychology, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Millings', 'Affiliation': 'Department of Psychology, The University of Sheffield, Sheffield, United Kingdom.'}]",Journal of medical Internet research,['10.2196/16794']
134,32384205,The efficacy and safety of a 577-nm high-power optically pumped semiconductor laser in the treatment of postacne erythema.,"BACKGROUND


Postacne erythema (PAE) is a common sequela of inflammatory acne vulgaris, treatment of which has been challenging due to limited options available and the variability of results for each modality. Recently, a 577-nm high-power optically pumped semiconductor laser (HOPSL) initially developed for vascular lesions has shown promising results for the treatment of PAE.
AIMS


To evaluate the efficacy and safety of 577-nm HOPSL in the treatment of postacne erythema.
METHODS


This was a split-face, randomized controlled trial pilot study. Twenty-one patients with PAE on both sides of their face were enrolled. Each subject's face sides were randomly assigned to either receive 577-nm HOPSL treatment (QuadroStar PRO™, Asclepion Laser Technologies) using the scanner handpiece, 1mm spot size, 80% coverage, 12-15 J/cm 2  , 30 ms, 2 passes for 3 sessions at 1-month intervals, or no treatment at all. Outcome measures such as overall improvement, the Erythema Index (EI), and Melanin Index (MI) from 3 different areas on both treatment and control sides were assessed at baseline, and 1-month follow-up after each treatment session. Side effects including pain, erythema, swelling, and crusting were also recorded.
RESULTS


Upon completion of the treatment period, the mean EI was significantly decreased in both treated and nontreated sides of the face (P < .001 and P = .001, respectively). The laser-treated sides already demonstrated significant reduction in the mean EI compared with nontreated sides at 1 month after the 2nd treatment (P = .007). The mean MI of both sides, however, did not show any statistically significant differences from baseline, and likewise when comparing between sides. Patients reported more improvement on laser-treated sides compared with nontreated sides. Reported side effects were limited to mild discomfort during treatment and transient facial erythema lasting approximately 30 minutes.
CONCLUSION


Patients who received treatment with the 577-nm HOPSL had better outcomes with minimal side effects at 1 month after 2 treatments as compared to those who did not receive any treatment. Therefore, the 577-nm HOPSL may be considered as an effective adjuvant treatment for PAE and early erythematous atrophic scars.",2020,The laser-treated sides already demonstrated significant reduction in the mean EI compared to non-treated sides at 1 month after the 2nd treatment (p=0.007).,"['Twenty-one patients with PAE on both sides of their face were enrolled', 'postacne erythema']","['577-nm high-power optically pumped semiconductor laser (HOPSL', '577-nm HOPSL', '577-nm HOPSL treatment (QuadroStar PRO TM  , Asclepion Laser Technologies, Jena, Germany) using the scanner handpiece', '577-nm high-power optically pumped semiconductor laser']","['minimal side effects', 'overall improvement, the Erythema Index (EI) and Melanin Index (MI', 'mean MI of both sides', 'efficacy and safety', 'pain, erythema, swelling, and crusting', 'mean EI']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}, {'cui': 'C0181115', 'cui_str': 'Handpiece'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0025196', 'cui_str': 'Melanin'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0205204', 'cui_str': 'Crust'}]",21.0,0.0328977,The laser-treated sides already demonstrated significant reduction in the mean EI compared to non-treated sides at 1 month after the 2nd treatment (p=0.007).,"[{'ForeName': 'Rungsima', 'Initials': 'R', 'LastName': 'Wanitphakdeedecha', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Kathryn Anne G', 'Initials': 'KAG', 'LastName': 'Cembrano', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Chanida', 'Initials': 'C', 'LastName': 'Ungaksornpairote', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Waritch', 'Initials': 'W', 'LastName': 'Kobwanthanakun', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Weeranut', 'Initials': 'W', 'LastName': 'Phothong', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sasima', 'Initials': 'S', 'LastName': 'Eimpunth', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Woraphong', 'Initials': 'W', 'LastName': 'Manuskiatti', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Fritz', 'Affiliation': 'Dermatology and Laser Center, Landau, Germany.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Salavastru', 'Affiliation': 'Carol Davila University of Medicine and Pharmacy, Bucharest, Romania.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13474']
135,32384291,"Ketamine and Magnesium for Refractory Neuropathic Pain: A Randomized, Double-blind, Crossover Trial.","BACKGROUND


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


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


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


The results of this trial in neuropathic pain refuted the hypothesis that ketamine provided pain relief at 5 weeks and cognitive-emotional benefit versus placebo and that a combination with magnesium had any additional analgesic effect.",2020,"There were no significant differences in emotional, sleep, and quality of life measures.","['20 patients with neuropathic pain', 'Refractory Neuropathic Pain', '20 patients with chronic neuropathic painNo effect of either the']","['placebo, ketamine, and ketamine/magnesium', 'ketamine or ketamine + magnesium', 'ketamine (0.5 mg/kg)/placebo or ketamine (0.5 mg/kg)/magnesium sulfate (3g) or placebo/placebo', 'ketamine', 'Ketamine', 'Ketamine and Magnesium', 'ketamine, ketamine/magnesium', 'ketamine/magnesium', 'saline, ketamine, and ketamine + magnesium infusions', 'magnesium', 'placebo']","['pain (at 7, 15, 21 and 28 days) and health-related, emotional, sleep, and quality of life questionnaires', 'pain relief', 'area under the curve of daily pain intensity', 'emotional, sleep, and quality of life measures', 'Daily pain intensity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0038720', 'cui_str': 'Inorganic sulfate'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",20.0,0.768198,"There were no significant differences in emotional, sleep, and quality of life measures.","[{'ForeName': 'Gisèle', 'Initials': 'G', 'LastName': 'Pickering', 'Affiliation': 'From University Hospital Clermont-Ferrand, Inserm CIC 1405, Clinical Pharmacology Department, F-63000 Clermont-Ferrand, France (G.P., V.M., A.C., F.G.) Clermont Auvergne University, Inserm 1107, F-63000 Clermont-Ferrand, France (G.P.) University Hospital Clermont-Ferrand, Clinical Research and Innovation Department, F-63000 Clermont-Ferrand, France (B.P., C.L.) University Hospital of Clermont-Ferrand, Assessment and Treatment of Pain Center, F-63000 Clermont-Ferrand, France (F.M., A.B.-B., E.C., N.D.) University Hospital Clermont-Ferrand, Clinical Research/Temporary Authorization Department, F-63000 Clermont-Ferrand, France (L.B.).'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': ''}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Morel', 'Affiliation': ''}, {'ForeName': 'Alexandrine', 'Initials': 'A', 'LastName': 'Corriger', 'Affiliation': ''}, {'ForeName': 'Fatiha', 'Initials': 'F', 'LastName': 'Giron', 'Affiliation': ''}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Marcaillou', 'Affiliation': ''}, {'ForeName': 'Assiya', 'Initials': 'A', 'LastName': 'Bidar-Beauvallot', 'Affiliation': ''}, {'ForeName': 'Evelyne', 'Initials': 'E', 'LastName': 'Chandeze', 'Affiliation': ''}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Lambert', 'Affiliation': ''}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Bernard', 'Affiliation': ''}, {'ForeName': 'Noémie', 'Initials': 'N', 'LastName': 'Delage', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003345']
136,32322920,"[Intensity-modulated fractionated radiotherapy vs. stereotactic body radiotherapy for prostate cancer (PACE-B): acute toxicity findings from an international, randomized, open-label, phase 3, noninferiority trial].",,2020,,[],['Intensity-modulated fractionated radiotherapy vs. stereotactic body radiotherapy'],[],[],"[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}]",[],,0.0827106,,"[{'ForeName': 'Gerhard G', 'Initials': 'GG', 'LastName': 'Grabenbauer', 'Affiliation': 'Strahlentherapie & Radioonkologie am Klinikum Coburg, Ketschendorfer Straße\xa033, 96450, Coburg, Deutschland. gg@diestrahlentherapeuten.de.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-020-01616-w']
137,32384612,Effects of 12 Weeks of Resistance Training on Cardiovascular Risk Factors in School Adolescents.,"Background and objectives:  The practice of physical exercise, especially resistance exercise, is important for the treatment and/or prevention of cardiovascular risk factors in adult individuals. However, there are few studies on its effects on adolescent individuals. Therefore, the aim of the present study was to evaluate the effects of applying a 12-week resistance training program on cardiovascular risk factors in adolescents.  Materials and Methods:  Thus, 122 adolescents aged 13-16 years of both genders participated in the study from school in the city of Lagarto, Sergipe (SE), Brazil, divided into two groups: Control Group (CG) and Group undergoing resistance training (RTG). Blood collection and anthropometric measurements were performed before and after the 12-week resistance training program (RTP).  Results:  After 12 weeks of the RTP in the adolescents, there was a reduction in the triglyceride variables (9.55%,  p  = 0.0286), Low-Density Lipoproteins (LDL) (5.42%,  p  = 0.0244), non-High-Density Lipoproteins (HDL) (5.40%,  p  = 0.0019), blood glucose (6.71%,  p  = 0.0040), systolic blood pressure (10.13%,  p  < 0.0001), as well as an increase in the body weight variable (1.73%,  p  = 0.0003).  Conclusions:  It was concluded that a 12-week RTP can prevent and/or alleviate the development of several chronic degenerative diseases in adulthood and that resistance training is important for maintaining the health of adolescents.",2020,It was concluded that a 12-week RTP can prevent and/or alleviate the development of several chronic degenerative diseases in adulthood and that resistance training is important for maintaining the health of adolescents.,"['adult individuals', 'School Adolescents', '122 adolescents aged 13-16 years of both genders participated in the study from school in the city of Lagarto, Sergipe (SE), Brazil, divided into two groups', 'adolescent individuals', 'adolescents']","['resistance training program', 'RTP', 'Control Group (CG) and Group undergoing resistance training (RTG', 'physical exercise, especially resistance exercise', 'Resistance Training']","['triglyceride variables', 'blood glucose', 'Blood collection and anthropometric measurements', 'cardiovascular risk factors', 'non-High-Density Lipoproteins (HDL', 'systolic blood pressure', 'Cardiovascular Risk Factors', 'Low-Density Lipoproteins (LDL', 'body weight variable']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0916139', 'cui_str': 'Stk38 protein, mouse'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0530684', 'cui_str': 'ezogabine'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C1535899', 'cui_str': 'Non-high-density lipoprotein cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",122.0,0.0161412,It was concluded that a 12-week RTP can prevent and/or alleviate the development of several chronic degenerative diseases in adulthood and that resistance training is important for maintaining the health of adolescents.,"[{'ForeName': 'Lorrany da', 'Initials': 'LD', 'LastName': 'Rosa Santos', 'Affiliation': 'Departamento de Educação Física, Universidade Federal de Sergipe, São Cristóvão 49040-780, Brazil.'}, {'ForeName': 'Silvan Silva de', 'Initials': 'SS', 'LastName': 'Araujo', 'Affiliation': 'Departamento de Educação Física, Universidade Federal de Sergipe, São Cristóvão 49040-780, Brazil.'}, {'ForeName': 'Erlânyo Francisco Dos Santos', 'Initials': 'EFDS', 'LastName': 'Vieira', 'Affiliation': 'Departamento de Educação Física, Universidade Federal de Sergipe, São Cristóvão 49040-780, Brazil.'}, {'ForeName': 'Charles Dos Santos', 'Initials': 'CDS', 'LastName': 'Estevam', 'Affiliation': 'Departamento de Fisiologia, Universidade Federal de Sergipe, São Cristóvão 49100-000, Brazil.'}, {'ForeName': 'Jymmys Lopes Dos', 'Initials': 'JLD', 'LastName': 'Santos', 'Affiliation': 'Departamento de Educação Física, Universidade Federal de Sergipe, São Cristóvão 49040-780, Brazil.'}, {'ForeName': 'Rogério Brandão', 'Initials': 'RB', 'LastName': 'Wichi', 'Affiliation': 'Departamento de Educação Física, Universidade Federal de Sergipe, São Cristóvão 49040-780, Brazil.'}, {'ForeName': 'Fábio Bessa', 'Initials': 'FB', 'LastName': 'Lima', 'Affiliation': 'Departamento de Fisiologia e Biofísica, Instituto de Ciências Biomédicas I (ICB I), Universidade de São Paulo, São Paulo 05508-000, Brazil.'}, {'ForeName': 'Carla Roberta Oliveira', 'Initials': 'CRO', 'LastName': 'Carvalho', 'Affiliation': 'Departamento de Fisiologia e Biofísica, Instituto de Ciências Biomédicas I (ICB I), Universidade de São Paulo, São Paulo 05508-000, Brazil.'}, {'ForeName': 'Felipe José', 'Initials': 'FJ', 'LastName': 'Aidar', 'Affiliation': 'Physical Education Department and Group of Studies and Research of Performance, Sport, Health and Paralympic Sports-GEPEPS, Universidade Federal de Sergipe, São Cristóvão 49100-000, Brazil.'}, {'ForeName': 'Anderson Carlos', 'Initials': 'AC', 'LastName': 'Marçal', 'Affiliation': 'Departamento de Morfologia, Universidade Federal de Sergipe, São Cristóvão 49100-000, Brazil.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56050220']
138,32384457,Randomized cross-over trial of demand oxygen delivery system.,"INTRODUCTION


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


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


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


jRCTs052190041.",2020,The demand oxygen delivery system (DODS) saves oxygen and extends the usable time of an oxygen cylinder,"['Twenty-six patients with chronic obstructive pulmonary disease or interstitial pneumonia', 'accordance with the Declaration of Helsinki and was registered on Aug 23, 2019 (https://jrct.niph.go.jp/en-latest-detail/jRCTs052190041', 'patients with respiratory failure']","['conventional DODS', 'auto-DODS or conventional DODS']","['hypoxemia and survival', 'mean oxygen saturation (SpO2) at rest and during the 6-minute walk test', 'ratios of the times during which the oxygen concentrator operates at each sensitivity mode (standard, high, and extra high) and at a constant pulse rate to the examination time, the ratio of the times during which SpO2 fall below 90% to the examination time, the lowest value of SpO2 during the examination time, the mean and highest pulse rates during the examination time, 6-minute walking distance, recovery time, Borg scale, comfort, and reliability, which are measured by a numerical rating scale and a questionnaire, respectively']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0206061', 'cui_str': 'Interstitial pneumonia'}, {'cui': 'C0018898', 'cui_str': 'Declaration of Helsinki'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0429622', 'cui_str': 'Oxygen delivery'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0182123', 'cui_str': 'Oxygen concentrator'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0449399', 'cui_str': 'Borg scale'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",26.0,0.0386822,The demand oxygen delivery system (DODS) saves oxygen and extends the usable time of an oxygen cylinder,"[{'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Nagano', 'Affiliation': 'Department of Internal Medicine, Division of Respiratory Medicine.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Internal Medicine, Division of Respiratory Medicine.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Omori', 'Affiliation': 'Clinical and Translational Research Center, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan.'}, {'ForeName': 'Takehiro', 'Initials': 'T', 'LastName': 'Otoshi', 'Affiliation': 'Department of Internal Medicine, Division of Respiratory Medicine.'}, {'ForeName': 'Kanoko', 'Initials': 'K', 'LastName': 'Umezawa', 'Affiliation': 'Department of Internal Medicine, Division of Respiratory Medicine.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Katsurada', 'Affiliation': 'Department of Internal Medicine, Division of Respiratory Medicine.'}, {'ForeName': 'Masatsugu', 'Initials': 'M', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Internal Medicine, Division of Respiratory Medicine.'}, {'ForeName': 'Motoko', 'Initials': 'M', 'LastName': 'Tachihara', 'Affiliation': 'Department of Internal Medicine, Division of Respiratory Medicine.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Nishimura', 'Affiliation': 'Department of Internal Medicine, Division of Respiratory Medicine.'}]",Medicine,['10.1097/MD.0000000000020010']
139,32384461,Efficacy of needle-knife combined with etanercept treatment regarding disease activity and hip joint function in ankylosing spondylitis patients with hip joint involvement: A randomized controlled study.,"This study aimed to assess the efficacy of needle-knife (NK) combined with etanercept (NKCE) in attenuating pain, inflammation, disease activity, and improving hip joint function in ankylosing spondylitis (AS) patients with hip joint involvement.Totally, 90 patients with active AS involving unilateral hip joint were enrolled and randomly assigned in 1:1:1 ratio to receive NKCE, NK or conventional drugs (control). The ESR, CRP, hip joint pain Visual Analogue Scale (VAS) score, bath ankylosing spondylitis disease activity index (BASDAI), bath ankylosing spondylitis functional index (BASFI), modified Harris hip score (mHHS), and range of motion (ROM) of affected hip joint were assessed at baseline (W0), after 1-week treatment (W1) and after 24-week treatment (W24).ESR and CRP were decreased in NKCE group compared with NK and control groups, while was not attenuated in NK group compared with control group. Regrading pain and disease activity, NKCE group presented a reduction in hip pain VAS score and BASDAI compared with NK and control groups, and NK group showed a decrease in hip pain VAS score and BASDAI compared with control group. Besides, BASFI was lowered in NKCE and NK groups compared with control group, but similar between NKCE and NK groups. mHHS and hip ROM were raised in NKCE and NK groups compared with control group, but similar between NKCE and NK groups.NKCE decreases hip pain, inflammation, disease activity and improves hip joint function in AS patients with hip joint involvement.",2020,"mHHS and hip ROM were raised in NKCE and NK groups compared with control group, but similar between NKCE and NK groups.","['90 patients with active AS involving unilateral hip joint', 'ankylosing spondylitis (AS) patients with hip joint involvement', 'AS patients with hip joint involvement', 'ankylosing spondylitis patients with hip joint involvement']","['needle-knife combined with etanercept', 'needle-knife (NK) combined with etanercept (NKCE', 'NKCE, NK or conventional drugs (control', 'NKCE']","['pain, inflammation, disease activity', 'BASFI', 'mHHS and hip ROM', 'Regrading pain and disease activity', 'disease activity and hip joint function', 'hip pain, inflammation, disease activity and improves hip joint function', 'hip pain VAS score and BASDAI', 'ESR, CRP, hip joint pain Visual Analogue Scale (VAS) score, bath ankylosing spondylitis disease activity index (BASDAI), bath ankylosing spondylitis functional index (BASFI), modified Harris hip score (mHHS), and range of motion (ROM) of affected hip joint']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}]","[{'cui': 'C0181464', 'cui_str': 'Needle knife'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C2363836', 'cui_str': 'Natural killer cell count'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0576002', 'cui_str': 'Hip joint - range of movement'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0019559', 'cui_str': 'Hip pain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C1998004', 'cui_str': 'Bath ankylosing spondylitis disease activity index'}, {'cui': 'C0013845', 'cui_str': 'Electron spin resonance measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}]",90.0,0.0265861,"mHHS and hip ROM were raised in NKCE and NK groups compared with control group, but similar between NKCE and NK groups.","[{'ForeName': 'Yuquan', 'Initials': 'Y', 'LastName': 'You', 'Affiliation': 'School of Biomedical Sciences, Huaqiao University.'}, {'ForeName': 'Meimei', 'Initials': 'M', 'LastName': 'Cai', 'Affiliation': 'Department of Ankylosing Spondylitis, Quanzhou Orthopedic-Traumatological Hospital of Fujian Traditional Chinese Medicine University, Quanzhou, China.'}, {'ForeName': 'Junsheng', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'School of Biomedical Sciences, Huaqiao University.'}, {'ForeName': 'Lianqun', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Ankylosing Spondylitis, Quanzhou Orthopedic-Traumatological Hospital of Fujian Traditional Chinese Medicine University, Quanzhou, China.'}, {'ForeName': 'Changxian', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Ankylosing Spondylitis, Quanzhou Orthopedic-Traumatological Hospital of Fujian Traditional Chinese Medicine University, Quanzhou, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'School of Biomedical Sciences, Huaqiao University.'}, {'ForeName': 'Yaping', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': 'Department of Ankylosing Spondylitis, Quanzhou Orthopedic-Traumatological Hospital of Fujian Traditional Chinese Medicine University, Quanzhou, China.'}]",Medicine,['10.1097/MD.0000000000020019']
140,32384462,Randomized cross-over trial of demand oxygen delivery system in nocturnal hypoxemia.,"BACKGROUND


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


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


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


The study was registered on Aug 23, 2019 (jRCTs052190042).",2020,"If the auto-DODS demonstrates non-inferiority to continuous flow in oxygenation during sleep, the auto-DODS can be used even at night, and the patient will need only 1 device.
","['nocturnal hypoxemia', 'Twenty patients with chronic obstructive pulmonary disease or interstitial pneumonia']","['demand oxygen delivery system', 'portable oxygen concentrator with an auto-DODS or a continuous-flow oxygen concentrator during sleep']","['mean oxygen saturation (SpO2) during the total sleep time', 'total sleep time, the lowest value of SpO2 during the total sleep time, the mean and highest pulse rate during the total sleep time, the apnoea index during the total sleep time, the total sleep duration itself, and comfort and reliability as measured by numerical rating scale and questionnaires', 'ratios of time that the oxygen concentrator spends in each sensitivity mode (standard, high, and extra-high) and at a constant pulse rate to the total sleep time, the total time and ratio of time for which SpO2']","[{'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0206061', 'cui_str': 'Interstitial pneumonia'}]","[{'cui': 'C0429622', 'cui_str': 'Oxygen delivery'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1618343', 'cui_str': 'Portable oxygen concentrator'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0182123', 'cui_str': 'Oxygen concentrator'}, {'cui': 'C0587116', 'cui_str': 'During sleep'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0182123', 'cui_str': 'Oxygen concentrator'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}]",20.0,0.0357811,"If the auto-DODS demonstrates non-inferiority to continuous flow in oxygenation during sleep, the auto-DODS can be used even at night, and the patient will need only 1 device.
","[{'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Nagano', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Omori', 'Affiliation': 'Clinical and Translational Research Center, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan.'}, {'ForeName': 'Takehiro', 'Initials': 'T', 'LastName': 'Otoshi', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine.'}, {'ForeName': 'Kanoko', 'Initials': 'K', 'LastName': 'Umezawa', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Katsurada', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine.'}, {'ForeName': 'Masatsugu', 'Initials': 'M', 'LastName': 'Yamamoto', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine.'}, {'ForeName': 'Motoko', 'Initials': 'M', 'LastName': 'Tachihara', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Nishimura', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine.'}]",Medicine,['10.1097/MD.0000000000020031']
141,32384676,"A Single-Arm, Prospective, Exploratory Study to Preliminarily Test Effectiveness and Safety of Skin Electrical Stimulation for Leber Hereditary Optic Neuropathy.","Leber hereditary optic neuropathy (LHON) is an intractable disease associated with mitochondrial DNA (mtDNA) mutations. In this preliminary, single-arm, prospective, open-label exploratory trial, we investigated the effectiveness and safety of skin electrical stimulation (SES) for cases of LHON harboring the mtDNA 11,778 mutation. Of the 11 enrolled patients, 10 completed six sessions of SES once every two weeks over a 10-week period. The primary outcome measure was the change in logarithm of the minimum angle of resolution (logMAR)-converted best-corrected visual acuity (BCVA) at one week after the last session of SES. The main secondary outcome measures were the logMAR BCVA at four and eight weeks and Humphrey visual field test sensitivities at one, four, and eight weeks. At all follow-up points, the logMAR BCVA had improved significantly from baseline [1.80 (1.70–1.80) at baseline, 1.75 (1.52–1.80) at one week, 1.75 (1.50–1.80) at four weeks, and 1.75 (1.52–1.80) at eight weeks;  p  < 0.05]. At eight weeks of follow-up, five patients showed >2-fold increase in the summed sensitivity at 52 measurement points from baseline. No adverse effects were observed. In conclusion, SES could be a viable treatment option for patients with LHON in the chronic phase harboring the mtDNA 11,778 mutation.",2020,No adverse effects were observed.,"['11 enrolled patients', 'Leber Hereditary Optic Neuropathy', 'cases of LHON harboring the mtDNA 11,778 mutation', 'patients with LHON in the chronic phase harboring the mtDNA 11,778 mutation']","['SES', 'Skin Electrical Stimulation', 'skin electrical stimulation (SES']","['logMAR BCVA at four and eight weeks and Humphrey visual field test sensitivities', 'summed sensitivity', 'change in logarithm of the minimum angle of resolution (logMAR)-converted best-corrected visual acuity (BCVA', 'logMAR BCVA', 'adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0917796', 'cui_str': ""Leber's optic atrophy""}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0012929', 'cui_str': 'Mitochondrial DNA'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0430866', 'cui_str': 'Humphrey perimeter plot'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",11.0,0.0623657,No adverse effects were observed.,"[{'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Kurimoto', 'Affiliation': 'Division of Ophthalmology, Department of Surgery, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Ueda', 'Affiliation': 'Division of Ophthalmology, Department of Surgery, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.'}, {'ForeName': 'Sotaro', 'Initials': 'S', 'LastName': 'Mori', 'Affiliation': 'Division of Ophthalmology, Department of Surgery, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.'}, {'ForeName': 'Seiko', 'Initials': 'S', 'LastName': 'Kamada', 'Affiliation': 'Division of Ophthalmology, Department of Surgery, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Sakamoto', 'Affiliation': 'Division of Ophthalmology, Department of Surgery, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Yamada-Nakanishi', 'Affiliation': 'Division of Ophthalmology, Department of Surgery, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Matsumiya', 'Affiliation': 'Division of Ophthalmology, Department of Surgery, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Division of Ophthalmology, Department of Surgery, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.'}]",Journal of clinical medicine,['10.3390/jcm9051359']
142,32384719,"A Low-Glycemic Index, High-Fiber, Pulse-Based Diet Improves Lipid Profile, but Does Not Affect Performance in Soccer Players.","Pulses (i.e., lentils, chickpeas, beans, peas) are low-glycemic index, high-fiber foods that are beneficial for improving blood lipids. Young soccer players typically have low dietary fiber intake, perhaps because of concerns regarding gastro-intestinal problems during exercise performance. Twenty-seven (17 females) soccer players were randomized to receive a pulse-based diet or their regular diet for four weeks in a cross-over study and evaluated for changes in blood lipids and athletic performance, with 19 (22 ± 6y; 12 females) completing the study (eight participants withdrew because of lack of time). Women increased high density lipoproteins (+0.5 ± 0.7 vs. -0.6 ± 0.3 mmol/L;  p  < 0.01) and reduced total cholesterol to high density lipoprotein ratio (-2.4 ± 2.9 vs. +2.6 ± 2.2;  p  < 0.01) on the pulse-based vs. regular diet, respectively, while there were no differences between diet phases in men. Athletic performance assessed by distance covered during games by a global positioning system was not significantly different during the pulse-based vs. regular diet (9180 ± 1618 vs. 8987 ± 1808 m per game;  p  = 0.35). It is concluded that a pulse-based diet can improve blood lipid profile without affecting athletic performance in soccer players.",2020,Athletic performance assessed by distance covered during games by a global positioning system was not significantly different during the pulse-based vs. regular diet (9180 ± 1618 vs. 8987 ± 1808 m per game;  ,"['Young soccer players', 'Twenty-seven (17 females) soccer players', 'soccer players', 'Soccer Players']",['pulse-based diet or their regular diet'],"['high density lipoproteins', 'blood lipid profile', 'total cholesterol to high density lipoprotein ratio']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0184625', 'cui_str': 'Normal diet'}]","[{'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0192598,Athletic performance assessed by distance covered during games by a global positioning system was not significantly different during the pulse-based vs. regular diet (9180 ± 1618 vs. 8987 ± 1808 m per game;  ,"[{'ForeName': 'Eliran', 'Initials': 'E', 'LastName': 'Mizelman', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, SK S7N 5B2, Canada.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Chilibeck', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, SK S7N 5B2, Canada.'}, {'ForeName': 'Abdul', 'Initials': 'A', 'LastName': 'Hanifi', 'Affiliation': 'College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, SK S7N 5A2, Canada.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Kaviani', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, SK S7N 5B2, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Brenna', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, SK S7N 5B2, Canada.'}, {'ForeName': 'Gordon A', 'Initials': 'GA', 'LastName': 'Zello', 'Affiliation': 'College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, SK S7N 5A2, Canada.'}]",Nutrients,['10.3390/nu12051324']
143,32384426,A phase I/IIa double blind single institute trial of low dose sirolimus for Pendred syndrome/DFNB4.,"INTRODUCTION


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


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


JMA-IIA00361; Pre-results.",2020,The number of occurrences and types of adverse events and of side effects will be sorted by clinical symptoms and by abnormal change of clinical test results.,"['patient with PDS/DFNB4', 'Sixteen of outpatients with fluctuating hearing diagnosed as PDS in SLC26A4 genetic testing aged in between 7 and 50 years old at the time of consent are given either', 'Pendred syndrome/DFNB4']","['placebo or sirolimus tablet (NPC-12T', 'placebo', 'NPC-12T placebo', 'sirolimus']","['number of occurrences and types of adverse events', 'safety and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C3538946', 'cui_str': 'Dilated Vestibular Aqueduct'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0231241', 'cui_str': 'Fluctuating'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0679560', 'cui_str': 'Genetic test'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0028587', 'cui_str': 'Nuclear Pore'}]","[{'cui': 'C0449789', 'cui_str': 'Number of occurrences'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.43163,The number of occurrences and types of adverse events and of side effects will be sorted by clinical symptoms and by abnormal change of clinical test results.,"[{'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Fujioka', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Akiyama', 'Affiliation': 'Clinical and Translational Research Center, Keio University Hospital, Tokyo, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Hosoya', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kayoko', 'Initials': 'K', 'LastName': 'Kikuchi', 'Affiliation': 'Clinical and Translational Research Center, Keio University Hospital, Tokyo, Japan.'}, {'ForeName': 'Yuto', 'Initials': 'Y', 'LastName': 'Fujiki', 'Affiliation': 'Clinical and Translational Research Center, Keio University Hospital, Tokyo, Japan.'}, {'ForeName': 'Yasuko', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Clinical and Translational Research Center, Keio University Hospital, Tokyo, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Yoshihama', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Ozawa', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Keita', 'Initials': 'K', 'LastName': 'Tsukada', 'Affiliation': 'Department of Otorhinolaryngology, Shinshu University School of Medicine, Nagano, Japan.'}, {'ForeName': 'Shin-Ya', 'Initials': 'SY', 'LastName': 'Nishio', 'Affiliation': 'Department of Otorhinolaryngology, Shinshu University School of Medicine, Nagano, Japan.'}, {'ForeName': 'Shin-Ichi', 'Initials': 'SI', 'LastName': 'Usami', 'Affiliation': 'Department of Otorhinolaryngology, Shinshu University School of Medicine, Nagano, Japan.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Matsunaga', 'Affiliation': 'Department of Otolaryngology, National Hospital Organization Tokyo Medical Center, Tokyo, Japan.'}, {'ForeName': 'Tomonobu', 'Initials': 'T', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Pediatrics, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Department of Preventive Medicine and Public Health, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Ogawa', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Keio University School of Medicine, Tokyo, Japan.'}]",Medicine,['10.1097/MD.0000000000019763']
144,32384434,In vivo investigation on bio-markers of perimenopausal panic disorder and catgut embedding acupoints mechanism.,"BACKGROUND


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


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


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


Chinese Clinical Trial Registry, ChiCTR-INR-16009724, registered in November 2016.",2020,The changes in Hamilton Anxiety Scale (HAMA) Score and Symptom Checklist 90 (SCL-90) Score will also be compared between these two groups.,"['70 outpatients with perimenopausal PD recruited from two hospitals of Chinese Medicine', 'perimenopausal PD', 'Perimenopausal women']","['Alprazolam', 'acupoint catgut embedding treatment two weeks a time in the following predefined acupuncture points: Shenshu (BL23), Sanyinjiao (SP6), Guanyuan (RN4), Ganshu (BL18), Zusanli (ST36) and Pishu (BL20', 'control group (Group Medication', 'functional magnetic resonance imaging (fMRI) and proton magnetic resonance spectroscopy (1H-MRS) scans', 'acupoint catgut embedding']","['frequency of panic attack, Panic Disorder Severity Score (PDSS), and Panic-associated Symptoms Score (PASS', 'Hamilton Anxiety Scale (HAMA) Score and Symptom Checklist 90 (SCL-90) Score']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C3839366', 'cui_str': 'Perimenopausal state'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0002333', 'cui_str': 'Alprazolam'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0007420', 'cui_str': 'Catgut'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0450614', 'cui_str': 'BL20'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C3850002', 'cui_str': '1H-MRS'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0086769', 'cui_str': 'Panic attack'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C0521989', 'cui_str': 'Associated symptom'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist'}]",70.0,0.0811251,The changes in Hamilton Anxiety Scale (HAMA) Score and Symptom Checklist 90 (SCL-90) Score will also be compared between these two groups.,"[{'ForeName': 'Guizhen', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': ""The Bao'an District TCM Hospital, The Affiliated Hospital of Guangzhou University of Chinese Medicine, Shenzhen.""}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Clinical Medical College of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Clinical Medical College of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Xiaokang', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Clinical Medical College of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Junquan', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'Clinical Medical College of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Yunxiang', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Clinical Medical College of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.'}]",Medicine,['10.1097/MD.0000000000019909']
145,32384437,Extracorporeal shock wave therapy versus corticosteroid injection for chronic plantar fasciitis: A protocol of randomized controlled trial.,"BACKGROUND


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


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


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


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


This study protocol was registered in Research Registry (researchregistry5428).",2020,Eighty patients with unilateral plantar fasciitis were randomized to receive either ESWT (3 times once per week) (n = 40) or CSI treatment (a single 1-mL dose of betamethasone sodium plus 0.5 mL of prilocaine under ultrasound guidance by injection into the plantar fascia) (n = 40).,"['chronic plantar fasciitis', 'plantar fasciitis among Chinese population', 'plantar fasciitis', 'Eighty patients with unilateral plantar fasciitis']","['corticosteroid injection (CSI) and extracorporeal shock wave therapy (ESWT', 'ultrasound-guided CSI versus medium frequency ESWT', 'betamethasone sodium plus 0.5\u200amL of prilocaine', 'Extracorporeal shock wave therapy versus corticosteroid injection', 'CSI treatment', 'ESWT', 'CSI versus ESWT']","['visual analog scale and Foot Function Index scores', 'heel tenderness index score and plantar fascia thickness as obtained by ultrasound examination']","[{'cui': 'C1136148', 'cui_str': 'Fasciitis, Plantar, Chronic'}, {'cui': 'C0149756', 'cui_str': 'Plantar fasciitis'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0033124', 'cui_str': 'Prilocaine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C4706287', 'cui_str': 'Foot Function Index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0549109', 'cui_str': 'Plantar fascia structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0948501', 'cui_str': 'Ultrasound examination'}]",80.0,0.206775,Eighty patients with unilateral plantar fasciitis were randomized to receive either ESWT (3 times once per week) (n = 40) or CSI treatment (a single 1-mL dose of betamethasone sodium plus 0.5 mL of prilocaine under ultrasound guidance by injection into the plantar fascia) (n = 40).,"[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': ""Department of Traumatic Orthopedics, Weifang People's Hospital, Weifang, Shandong, 261041.""}, {'ForeName': 'Wen Ming', 'Initials': 'WM', 'LastName': 'Luo', 'Affiliation': ""Department of Traumatic Orthopedics, Weifang People's Hospital, Weifang, Shandong, 261041.""}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Ultrasound, Weifang Maternal and Child health Hospital, Weifang, Shandong, 261000, China.'}]",Medicine,['10.1097/MD.0000000000019920']
146,32391709,"Single-session digital intervention for adolescent depression, anxiety, and well-being: Outcomes of a randomized controlled trial with Kenyan adolescents.","BACKGROUND


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


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


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


This is the first report that a brief, computerized SSI may reduce depressive symptoms in adolescents in sub-Saharan Africa. Replication trials with extended follow-ups will help gauge the strength and durability of these effects. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Compared to the control, Shamiri-Digital produced a greater reduction in adolescent depressive symptoms in both the full sample (p = .028, d = 0.50) and a subsample of youths with moderate to severe depression symptoms (p = .010, d = 0.83) from baseline to 2-week follow-up.","['Kenyan adolescents', 'High school students (N = 103, age 13-18', 'adolescents in sub-Saharan Africa']","['computerized SSI', 'digital SSI Shamiri-Digital (Shamiri means ""thrive"" in Kiswahili) or a study-skills control intervention', 'Single-session digital intervention', 'computerized single-session interventions (SSIs']","['severe depression symptoms', 'anxiety symptoms, well-being, or happiness', 'depressive symptoms', 'adolescent depressive symptoms']","[{'cui': 'C0337839', 'cui_str': 'Kenyans'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2938208', 'cui_str': 'Thrive'}, {'cui': 'C0871455', 'cui_str': 'Study Skills'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0588008', 'cui_str': 'Severe depression'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",,0.0872907,"Compared to the control, Shamiri-Digital produced a greater reduction in adolescent depressive symptoms in both the full sample (p = .028, d = 0.50) and a subsample of youths with moderate to severe depression symptoms (p = .010, d = 0.83) from baseline to 2-week follow-up.","[{'ForeName': 'Tom L', 'Initials': 'TL', 'LastName': 'Osborn', 'Affiliation': 'Department of Psychology, Harvard University.'}, {'ForeName': 'Micaela', 'Initials': 'M', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Psychology, Harvard University.'}, {'ForeName': 'Akash R', 'Initials': 'AR', 'LastName': 'Wasil', 'Affiliation': 'Department of Psychology, University of Pennsylvania.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Venturo-Conerly', 'Affiliation': 'Department of Psychology, Harvard University.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Gan', 'Affiliation': 'Department of Psychology, Harvard University.'}, {'ForeName': 'Rediet G', 'Initials': 'RG', 'LastName': 'Alemu', 'Affiliation': 'Department of Psychology, Harvard University.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Roe', 'Affiliation': 'Department of Psychology, Harvard University.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Arango G', 'Affiliation': 'Department of Psychology, Harvard University.'}, {'ForeName': 'Benny H', 'Initials': 'BH', 'LastName': 'Otieno', 'Affiliation': 'Shamiri Institute.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Wasanga', 'Affiliation': 'Department of Psychology, Kenyatta University.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Shingleton', 'Affiliation': 'Department of Psychology, Harvard University.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Weisz', 'Affiliation': 'Department of Psychology, Harvard University.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000505']
147,32388895,Pulmonary Metastasectomy in Colorectal Cancer: updated analysis of 93 randomized patients - control survival is much better than previously assumed.,"AIM


Lung metastases from colorectal cancer are resected in selected patients in the belief that this confers a significant survival advantage. It is generally assumed that the 5-year survival of these patients would be near zero without metastasectomy. We tested the clinical effectiveness of this practice in Pulmonary Metastasectomy in Colorectal Cancer (PulMiCC), a randomized, controlled noninferiority trial.
METHOD


Multidisciplinary teams in 14 hospitals recruited patients with resectable lung metastases into a two-arm trial. Randomization was remote and stratified according to site, with minimization for age, sex, primary cancer stage, interval since primary resection, prior liver involvement, number of metastases and carcinoembryonic antigen level. The trial management group was blind to patient allocation until after intention-to-treat analysis.
RESULTS


From 2010 to 2016, 93 participants were randomized. These patients were 35-86 years of age and had between one and six lung metastases at a median of 2.7 years after colorectal cancer resection; 29% had prior liver metastasectomy. The patient groups were well matched and the characteristics of these groups were similar to those of observational studies. The median survival after metastasectomy was 3.5 (95% CI: 3.1-6.6) years compared with 3.8 (95% CI: 3.1-4.6) years for controls. The estimated unadjusted hazard ratio for death within 5 years, comparing the metastasectomy group with the control group, was 0.93 (95% CI: 0.56-1.56). Use of chemotherapy or local ablation was infrequent and similar in each group.
CONCLUSION


Patients in the control group (who did not undergo lung metastasectomy) have better survival than is assumed. Survival in the metastasectomy group is comparable with the many single-arm follow-up studies. The groups were well matched with features similar to those reported in case series.",2020,"The estimated unadjusted hazard ratio for death within five years, comparing metastasectomy to control, was 0.93 (95%CI:0.56,1.56).","['From 2010 to 2016, 93 participants were randomised, aged 35 to 86 years, with 1-6 lung metastases at a median of 2.7 years after colorectal cancer resection', '14 hospitals recruited patients with resectable lung metastases into a two-arm trial', 'Colorectal Cancer (PulMiCC']",['chemotherapy or local ablation'],"['Survival', 'median survival']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0153676', 'cui_str': 'Secondary malignant neoplasm of lung'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",93.0,0.290895,"The estimated unadjusted hazard ratio for death within five years, comparing metastasectomy to control, was 0.93 (95%CI:0.56,1.56).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Milosevic', 'Affiliation': 'Institute for Lung Diseases of Vojvodina, Thoracic Surgery Clinic, Sremska Kamenica, Serbia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Edwards', 'Affiliation': 'Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Tsang', 'Affiliation': 'Basildon and Thurrock University Hospitals NHS Foundation Trust, Basildon, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dunning', 'Affiliation': 'South Tees Hospitals NHS Foundation Trust, The James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Shackcloth', 'Affiliation': 'Liverpool Heart And Chest Hospital NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Batchelor', 'Affiliation': 'Bristol Royal Infirmary, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Coonar', 'Affiliation': 'Royal Papworth Hospital NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hasan', 'Affiliation': 'The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Davidson', 'Affiliation': 'Division of Surgery, Royal Free London NHS Foundation Trust, UCL, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Marchbank', 'Affiliation': 'Derriford Hospital, University Hospitals Plymouth NHS Trust, Plymouth, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Grumett', 'Affiliation': 'The Royal Wolverhampton NHS Trust, New Cross Hospital, Wolverhampton, UK.'}, {'ForeName': 'N R', 'Initials': 'NR', 'LastName': 'Williams', 'Affiliation': 'Surgical & Interventional Trials Unit (SITU), University College London, London, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Macbeth', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Farewell', 'Affiliation': 'MRC Biostatistics Unit, Cambridge, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Treasure', 'Affiliation': 'Clinical Operational Research Unit, University College London, London, UK.'}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.15113']
148,32332564,"The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial.",,2020,,['after Abdominally Based Autologous Microvascular Breast Reconstruction'],"['Bupivacaine Hydrochloride', 'Liposomal Bupivacaine']",['Transversus Abdominis Plane Block'],"[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine hydrochloride'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]",,0.200618,,"[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Knackstedt', 'Affiliation': 'Department of Plastic Surgery, Cleveland Clinic Division of Plastic Surgery, MetroHealth Department of Plastic Surgery, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gatherwright', 'Affiliation': ''}, {'ForeName': 'Risal', 'Initials': 'R', 'LastName': 'Djohan', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006782']
149,32384502,Comparison of high tone therapy and transcutaneous electrical nerve stimulation therapy in chemotherapy-induced polyneuropathy.,"INTRODUCTION


Chemotherapy-induced peripheral neuropathy (CIPN) is a worldwide concern in patients receiving neurotoxic agents for cancer therapy. High tone external muscle stimulation is a promising therapeutic approach to alleviate symptoms of CIPN.
METHODS


This pilot study aims to investigate whether the application of home-based high-tone external muscle stimulation therapy (HTEMS) improves symptoms of CIPN. The trial is planned as a therapist- and assessor-blinded, 1:1 randomized controlled study. A total of 50 patients with chemotherapy-induced peripheral polyneuropathy will be included. All patients will perform therapy at home. Study participants will be allocated randomly to the HTEMS therapy (intervention group) or to the transcutaneous electrical nerve stimulation (TENS, control group), respectively, following a standardized therapy schedule. Compliance of participants can be verified by reading out the tool box. Outcomes will be evaluated at baseline and after 8 weeks of home-based therapy. The primary outcome includes improvement of CIPN according to the patient-reported EORTC QLQ-CIPN 20 questionnaire. Secondary outcomes are the patient-reported change in health-related quality of life and clinician-reported changes of vibration sensibility, tendon reflexes, temperature sensibility, perception of touch, and strength of the lower leg muscles. Further a safety- and process evaluation will be performed.
DISCUSSION


This pilot RCT aims to evaluate the impact of home-based HTEMS as compared to TENS in CIPN. There is a need for an effective treatment for CIPN and the results of this study are expected to possibly identify a novel and effective treatment strategy in the future.",2020,The primary outcome includes improvement of CIPN according to the patient-reported EORTC QLQ-CIPN 20 questionnaire.,"['chemotherapy-induced polyneuropathy', '50 patients with chemotherapy-induced peripheral polyneuropathy', 'patients receiving neurotoxic agents for cancer therapy']","['HTEMS therapy (intervention group) or to the transcutaneous electrical nerve stimulation (TENS, control group', 'home-based high-tone external muscle stimulation therapy (HTEMS', 'Chemotherapy-induced peripheral neuropathy (CIPN', 'high tone therapy and transcutaneous electrical nerve stimulation therapy', 'High tone external muscle stimulation']","['improvement of CIPN according to the patient-reported EORTC QLQ-CIPN 20 questionnaire', 'patient-reported change in health-related quality of life and clinician-reported changes of vibration sensibility, tendon reflexes, temperature sensibility, perception of touch, and strength of the lower leg muscles']","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0014518', 'cui_str': 'Lyell syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}]","[{'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0439823', 'cui_str': 'Sensibilities'}, {'cui': 'C0034943', 'cui_str': 'Peripheral reflex'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C2350522', 'cui_str': 'Touch perception'}, {'cui': 'C0230446', 'cui_str': 'Both lower legs'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",50.0,0.0546638,The primary outcome includes improvement of CIPN according to the patient-reported EORTC QLQ-CIPN 20 questionnaire.,"[{'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Schaffler-Schaden', 'Affiliation': 'Institute of General Practice, Family Medicine and Preventive Medicine.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Sassmann', 'Affiliation': 'Institute of Physical Medicine and Rehabilitation.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Johansson', 'Affiliation': 'Institute of General Practice, Family Medicine and Preventive Medicine.'}, {'ForeName': 'Simon P', 'Initials': 'SP', 'LastName': 'Gampenrieder', 'Affiliation': 'Department of Internal Medicine III with Haematology, Medical Oncology, Haemostaseology, Infectiology and Rheumatology, Oncologic Center, Salzburg Cancer Research Institute - Laboratory for Immunological and Molecular Cancer Research (SCRI-LIMCR).'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Rinnerthaler', 'Affiliation': 'Department of Internal Medicine III with Haematology, Medical Oncology, Haemostaseology, Infectiology and Rheumatology, Oncologic Center, Salzburg Cancer Research Institute - Laboratory for Immunological and Molecular Cancer Research (SCRI-LIMCR).'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Lampl', 'Affiliation': 'Institute of Physical Medicine and Rehabilitation.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Herfert', 'Affiliation': 'Institute of Physical Medicine and Rehabilitation.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Lenzhofer', 'Affiliation': 'Institute of Physical Medicine and Rehabilitation.'}, {'ForeName': 'Yvonne T', 'Initials': 'YT', 'LastName': 'Landkammer', 'Affiliation': 'Institute of Physical Medicine and Rehabilitation.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Rieder', 'Affiliation': 'Institute of Physical Medicine and Rehabilitation.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'Department of Internal Medicine III with Haematology, Medical Oncology, Haemostaseology, Infectiology and Rheumatology, Oncologic Center, Salzburg Cancer Research Institute - Laboratory for Immunological and Molecular Cancer Research (SCRI-LIMCR).'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Flamm', 'Affiliation': 'Institute of General Practice, Family Medicine and Preventive Medicine.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Niebauer', 'Affiliation': 'Institute of Physical Medicine and Rehabilitation.'}]",Medicine,['10.1097/MD.0000000000020149']
150,32384504,Efficacy of baby shampoo and commercial eyelid cleanser in patients with meibomian gland dysfunction: A randomized controlled trial.,"BACKGROUND


To compare the efficacy between Johnson's baby shampoo top-to-toe (No More Tears formula) and OCuSOFT Lid Scrub Original Foaming Eyelid Cleanser (OSO) in patients with grade 2 meibomian gland dysfunction (MGD).
METHODS


Sixty participants with grade 2 MGD were enrolled and analyzed based on intention to treat basis in a prospective, randomized, single-blind trial for eye scrub using either diluted baby shampoo or OSO. The data collection included the Ocular Surface Disease Index (OSDI) questionnaire, compliance, and complications. The eye examinations were according to the Tear Film and Ocular Surface Society at baseline and at post-treatment weeks 4 and 12.
RESULTS


The mean (±SD) age of the 60 patients who presented with grade 2 MGD was 48.0 ± 13.8 years and 75.0% were females. The OSDI scores of these participants between pre-treatment and post-treatment weeks 4 and 12 improved significantly in both groups (all P < .001). The mean (±SD) differences of the improvement of OSDI score from baseline were not statistically significantly different between the baby shampoo and OSO groups at post-treatment weeks 4 and 12 (P = .57 and P = .54, respectively). The compliance and complications were also not statistically significant between the 2 groups.
CONCLUSIONS


Eyelid scrub using either baby shampoo or OSO and warm compresses could significantly reduce eye irritability and uncomfortable symptoms in grade 2 MGD patients. In this study, the efficacy, compliance, and complications between the 2 groups were not statistically significantly different.",2020,The OSDI scores of these participants between pre-treatment and post-treatment weeks 4 and 12 improved significantly in both groups (all P < .001).,"['patients with meibomian gland dysfunction', '60 patients who presented with grade 2 MGD was 48.0\u200a±\u200a13.8 years and 75.0% were females', 'grade 2 MGD patients', 'patients with grade 2 meibomian gland dysfunction (MGD', 'Sixty participants with grade 2 MGD']","['baby shampoo and commercial eyelid cleanser', 'OCuSOFT Lid Scrub Original Foaming Eyelid Cleanser (OSO', 'diluted baby shampoo or OSO']","['OSDI scores', 'eye irritability and uncomfortable symptoms', 'OSDI score', 'Ocular Surface Disease Index (OSDI) questionnaire, compliance, and complications', 'compliance and complications', 'efficacy, compliance, and complications', 'Tear Film and Ocular Surface Society']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1275684', 'cui_str': 'Meibomian gland dysfunction'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C4517561', 'cui_str': '13.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0150765', 'cui_str': 'Shampoo'}, {'cui': 'C0015426', 'cui_str': 'Eyelid structure'}, {'cui': 'C0722230', 'cui_str': 'Ocusoft'}, {'cui': 'C2946035', 'cui_str': 'Scrubs'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0991510', 'cui_str': 'Foam'}]","[{'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0037455', 'cui_str': 'Societies'}]",60.0,0.0646905,The OSDI scores of these participants between pre-treatment and post-treatment weeks 4 and 12 improved significantly in both groups (all P < .001).,"[{'ForeName': 'Orapan', 'Initials': 'O', 'LastName': 'Aryasit', 'Affiliation': ''}, {'ForeName': 'Yuwarat', 'Initials': 'Y', 'LastName': 'Uthairat', 'Affiliation': ''}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Singha', 'Affiliation': ''}, {'ForeName': 'Orasa', 'Initials': 'O', 'LastName': 'Horatanaruang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020155']
151,32384509,To explore the clinical efficacy of Traditional Chinese Medicine bath in the treatment of psoriasis vulgaris with blood-heat syndrome and its effect on related cytokines based on different temperature and different concentration.,"BACKGROUND


Chinese herbal bath has long been used in the curative treatment of psoriasis vulgaris. However, there is no unified standard protocol for Chinese herbal bath. Many factors affect the curative effect of Chinese herbal bath, such as water temperature, bath concentration, and soaking time. Most studies involving Chinese herbal bath has described the bath generally, and few studies have investigated the factors that might contribute to the efficacy of Chinese herbal bath. Here we describe a protocol to evaluate the efficacy and safety of various bathwater temperatures and herbal concentrations on psoriasis vulgaris, and their effect on serum vascular endothelial growth factor (VEGF), tumor necrosis factor α (TNF-α), interleukin 23 (IL-23), and interleukin 17 (IL-17). These data could be useful for optimizing Chinese herbal bath treatments.
METHODS


In this randomized controlled trial, we planned to recruit 288 hospitalized atients with psoriasis vulgaris aged 18 to 65 years. All participants who meet the inclusion criteria will be randomly assigned to the observation group, the control group, or the basic treatment group. The observation group will be divided into 6 sub-groups according to water temperatures and bath concentrations, designated as observation groups 1 to 6. Thirty-six participants will be assigned to each group. The basic treatment group will be given co-qingdai capsule, po 2 g tid; compound glycyrrhizin tablet, po 75 mg tid; AA Skincare jojoba Oil, us.ext qd. The observation group will be given a Chinese herbal bath at the same time as the basic treatment. The control group will be given ozone hydrotherapy at the same time as the basic treatment. The entire treatment course will last for 2 weeks. The following parameters will be compared in each group, before and 2 weeks after treatment: the psoriasis area and severity index score (PASI), pruritus score, clinical efficacy, and dermatology life quality index score (DLQI); serum levels of serum VEGF, TNF-α, IL-23, and IL-17; and confocal laser scanning microscope images.
CONCLUSION


This study will evaluate the efficacy and safety of various Chinese herbal bath conditions (water temperatures and herbal concentrations) on the treatment of psoriasis vulgaris, which will provide an important reference for the operation of Chinese herbal bath.
TRIAL REGISTRATION NUMBER


ChiCTR1900027468.",2020,"The following parameters will be compared in each group, before and 2 weeks after treatment: the psoriasis area and severity index score (PASI), pruritus score, clinical efficacy, and dermatology life quality index score (DLQI); serum levels of serum VEGF, TNF-α, IL-23, and IL-17; and confocal laser scanning microscope images.
","['288 hospitalized atients with psoriasis vulgaris aged 18 to 65 years', 'psoriasis vulgaris with blood-heat syndrome']","['Traditional Chinese Medicine bath', 'glycyrrhizin tablet, po 75\u200amg tid; AA Skincare jojoba Oil, us.ext qd', 'ozone hydrotherapy', 'various Chinese herbal bath conditions (water temperatures and herbal concentrations']","['efficacy and safety', 'serum vascular endothelial growth factor (VEGF), tumor necrosis factor α (TNF-α), interleukin 23 (IL-23), and interleukin 17 (IL-17', 'psoriasis area and severity index score (PASI), pruritus score, clinical efficacy, and dermatology life quality index score (DLQI); serum levels of serum VEGF, TNF-α, IL-23, and IL-17; and confocal laser scanning microscope images']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0263361', 'cui_str': 'Psoriasis vulgaris'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0061751', 'cui_str': 'Glycyrrhizic Acid'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0064161', 'cui_str': 'jojoba wax'}, {'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0963088', 'cui_str': 'IL-23'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C4706308', 'cui_str': 'DLQI (Dermatology Life Quality Index) score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0181839', 'cui_str': 'Microscope'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]",36.0,0.0598044,"The following parameters will be compared in each group, before and 2 weeks after treatment: the psoriasis area and severity index score (PASI), pruritus score, clinical efficacy, and dermatology life quality index score (DLQI); serum levels of serum VEGF, TNF-α, IL-23, and IL-17; and confocal laser scanning microscope images.
","[{'ForeName': 'Wenxia', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': 'Department of Dermatology, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Qianying', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': 'Department of Dermatology, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Yuesi', 'Initials': 'Y', 'LastName': 'Qin', 'Affiliation': 'School of Clinical Medicine, Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Dai', 'Affiliation': 'Chengdu Yinkang Psoriasis Hospital, Chengdu, Sichuan Province, PR China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': 'Chengdu Yinkang Psoriasis Hospital, Chengdu, Sichuan Province, PR China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Jiao', 'Affiliation': 'Department of Dermatology, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Dermatology, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Shengzhen', 'Initials': 'S', 'LastName': 'Ye', 'Affiliation': 'Department of Dermatology, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Jiahao', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Dermatology, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Mingling', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Department of Dermatology, Hospital of Chengdu University of Traditional Chinese Medicine.'}]",Medicine,['10.1097/MD.0000000000020172']
152,32387326,The influence of postoperative environment on patient pain and satisfaction: a randomized trial.,"BACKGROUND


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


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


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


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


In this randomized trial, we found music and landscape imagery did not substantially affect postoperative pain scores; however, they had a positive effect on the postoperative experience. Furthermore, this effect appeared to broaden 2 weeks after surgery. Given the importance of value-based care, interventions such as these should be emphasized to enhance patient satisfaction, quality scores, and overall well-being.",2020,Total morphine equivalents (p=0.817) and nursing pain scores (p=0.774) were also similar.,"['One hundred thirty-three subjects were enrolled; primary outcome data was available for 92 (46 per arm', 'The mean age was 63.8 (SD 9.5) years, median Charlson Comorbidity score was 2 (min=0,max=7), and 94.6% were Caucasian', 'inpatients undergoing pelvic reconstructive surgery', 'Exclusions included history of a chronic pain or substance abuse', 'Eligible candidates were 18-85 years old, English speaking, and scheduled to undergo native tissue vaginal vault suspension for symptomatic pelvic organ prolapse']","['standard hospital room, without music or landscape', 'Postoperative Environment']","['VAS pain score', 'Total morphine equivalents', 'healing environment', 'nursing pain scores', 'narcotic use, likelihood to refer family to the same hospital facility, satisfaction with care and the hospital, and perception of a healing environment', 'Patient Pain and Satisfaction', 'higher satisfaction with their care', 'Visual Analogue Scale (VAS) for pain on the morning of post-operative day one', 'pain and satisfaction scores', 'median VAS scores for pain']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0524865', 'cui_str': 'Reconstruction - action'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0740858', 'cui_str': 'Substance abuse'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0227794', 'cui_str': 'Structure of fornix of vagina'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",133.0,0.174362,Total morphine equivalents (p=0.817) and nursing pain scores (p=0.774) were also similar.,"[{'ForeName': 'Austin M', 'Initials': 'AM', 'LastName': 'Hill', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, TriHealth Good Samaritan Hospital, Cincinnati, OH. Electronic address: austinm.hill1@gmail.com.'}, {'ForeName': 'Catrina C', 'Initials': 'CC', 'LastName': 'Crisp', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, TriHealth Good Samaritan Hospital, Cincinnati, OH.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Shatkin-Margolis', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, TriHealth Good Samaritan Hospital, Cincinnati, OH.'}, {'ForeName': 'Tiffanie', 'Initials': 'T', 'LastName': 'Tam', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, TriHealth Good Samaritan Hospital, Cincinnati, OH.'}, {'ForeName': 'Eunsun', 'Initials': 'E', 'LastName': 'Yook', 'Affiliation': 'Hatton Research Institute, TriHealth Good Samaritan Hospital, Cincinnati, OH.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Kleeman', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, TriHealth Good Samaritan Hospital, Cincinnati, OH.'}, {'ForeName': 'Rachel N', 'Initials': 'RN', 'LastName': 'Pauls', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, TriHealth Good Samaritan Hospital, Cincinnati, OH.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.05.006']
153,32392715,"Impact of Intensive Lifestyle Treatment (Diet Plus Exercise) on Endothelial and Vascular Function, Arterial Stiffness and Blood Pressure in Stage 1 Hypertension: Results of the HINTreat Randomized Controlled Trial.","Lifestyle modification is an important component of essential hypertension (EH) therapy. The aim of the Hypertension Intensive Nutrition Treatment (HINTreat) parallel, randomized controlled trial was to examine the effect of a 6-month intensive lifestyle treatment (ILT) (diet plus exercise with monthly visits) compared to the usual care. A total of 76 adults with stage 1 EH were randomized (38 in each group). Dietary analysis, anthropometry, physical activity, biochemical and urine profile, blood pressure (BP), asymmetric dimethylarginine (ADMA), central hemodynamics, β-stiffness index and carotid intima media-thickness were evaluated. The dietary inflammatory index (DII) was calculated for each participant from the intake of 29 nutrients/food components. At the end of the trial, participants in the ILT group reduced their 24h urinary Na excretion ( p  ≤ 0.001), daytime systolic BP ( p  ≤ 0.048) and mean carotid β-stiffness index ( p  ≤ 0.005) and ameliorated their lipidemic profile compared to the standard care. Univariate analysis for the total sample showed a strong association between DII and ADMA levels (β = 0.089,  p  ≤ 0.01). ILT is effective in improving the inflammatory components of the diet and selected cardiometabolic parameters, including arterial stiffness.",2020,"At the end of the trial, participants in the ILT group reduced their 24h urinary Na excretion ( p  ≤ 0.001), daytime systolic BP ( p  ≤ 0.048) and mean carotid β-stiffness index ( p  ≤ 0.005) and ameliorated their lipidemic profile compared to the standard care.","['Stage 1 Hypertension', '76 adults with stage 1 EH']","['ILT', 'intensive lifestyle treatment (ILT) (diet plus exercise with monthly visits', 'Intensive Lifestyle Treatment (Diet Plus Exercise']","['Endothelial and Vascular Function, Arterial Stiffness and Blood Pressure', 'lipidemic profile', '24h urinary Na excretion', 'dietary inflammatory index (DII', 'Dietary analysis, anthropometry, physical activity, biochemical and urine profile, blood pressure (BP), asymmetric dimethylarginine (ADMA), central hemodynamics, β-stiffness index and carotid intima media-thickness', 'DII and ADMA levels', 'mean carotid β-stiffness index', 'daytime systolic BP']","[{'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0067385', 'cui_str': 'N,N-dimethylarginine'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",76.0,0.0675404,"At the end of the trial, participants in the ILT group reduced their 24h urinary Na excretion ( p  ≤ 0.001), daytime systolic BP ( p  ≤ 0.048) and mean carotid β-stiffness index ( p  ≤ 0.005) and ameliorated their lipidemic profile compared to the standard care.","[{'ForeName': 'Anastasios', 'Initials': 'A', 'LastName': 'Vamvakis', 'Affiliation': 'Third Department of Internal Medicine, Papageorgiou Hospital, Aristotle University of Thessaloniki, GR56403 Thessaloniki, Greece.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Gkaliagkousi', 'Affiliation': 'Third Department of Internal Medicine, Papageorgiou Hospital, Aristotle University of Thessaloniki, GR56403 Thessaloniki, Greece.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Lazaridis', 'Affiliation': 'Third Department of Internal Medicine, Papageorgiou Hospital, Aristotle University of Thessaloniki, GR56403 Thessaloniki, Greece.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Grammatikopoulou', 'Affiliation': 'Department of Nutritional Sciences & Dietetics, Faculty of Health Sciences, International Hellenic University, Alexander Campus, Sindos, PO Box 141, GR57400 Thessaloniki, Greece.'}, {'ForeName': 'Areti', 'Initials': 'A', 'LastName': 'Triantafyllou', 'Affiliation': 'Third Department of Internal Medicine, Papageorgiou Hospital, Aristotle University of Thessaloniki, GR56403 Thessaloniki, Greece.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Nikolaidou', 'Affiliation': 'Third Department of Internal Medicine, Papageorgiou Hospital, Aristotle University of Thessaloniki, GR56403 Thessaloniki, Greece.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Koletsos', 'Affiliation': 'Third Department of Internal Medicine, Papageorgiou Hospital, Aristotle University of Thessaloniki, GR56403 Thessaloniki, Greece.'}, {'ForeName': 'Panagiota', 'Initials': 'P', 'LastName': 'Anyfanti', 'Affiliation': 'Third Department of Internal Medicine, Papageorgiou Hospital, Aristotle University of Thessaloniki, GR56403 Thessaloniki, Greece.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Tzimos', 'Affiliation': 'Northern Greece Statistics Directorate, Hellenic Statistical Authority, 218 Delfon Str, GR54646 Thessaloniki, Greece.'}, {'ForeName': 'Pantelis', 'Initials': 'P', 'LastName': 'Zebekakis', 'Affiliation': 'Division of Endocrinology and Metabolism and Diabetes Center, First Department of Internal Medicine, Medical School, AHEPA University Hospital, Aristotle University of Thessaloniki, GR54621 Thessaloniki, Greece.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Douma', 'Affiliation': 'Third Department of Internal Medicine, Papageorgiou Hospital, Aristotle University of Thessaloniki, GR56403 Thessaloniki, Greece.'}]",Nutrients,['10.3390/nu12051326']
154,32392796,"Clinical Utility of Extracorporeal Shock Wave Therapy on Hypertrophic Scars of the Hand Caused by Burn Injury: A Prospective, Randomized, Double-Blinded Study.","Postburn hypertrophic scarring is a common complication in burn injuries to the hands, often associated with impaired hand function. We evaluated the effects of extracorporeal shock wave therapy (ESWT), compared to a sham stimulation therapy, on hypertrophic scars of the hand caused by burn injury and investigated its effects on hand function. This was a double-blinded, randomized, controlled trial of 48 patients with a burn to their dominant right hand. The parameters of ESWT were as follows: energy flux density, 0.05-0.30 mJ/mm 2 ; frequency, 4 Hz; 1000 to 2000 impulses per treatment; four treatments, once a week for four weeks. The outcomes measured were as follows: a 10-point visual analogue scale pain score; Vancouver scar scale for scar vascularity, height, pliability and pigmentation; ultrasound measurement of scar thickness; Jebsen-Taylor hand function test; grip strength; Perdue pegboard test; and the Michigan hand outcomes questionnaire. The change in the score from baseline to post-treatment was compared between the two groups. ESWT improved the pain score ( p  = 0.001), scar thickness ( p  = 0.018), scar vascularity ( p  = 0.0015), and improved hand function (simulated card-turning,  p  = 0.02; picking up small objects,  p  = 0.004). The other measured outcomes were not different between the two groups. ESWT is effective in decreasing pain, suppressing hypertrophic scarring, and improving hand function.",2020,"ESWT improved the pain score ( p  = 0.001), scar thickness ( p  = 0.018), scar vascularity ( p  = 0.0015), and improved hand function (simulated card-turning,  p  = 0.02; picking up small objects,  p  = 0.004).","['Hypertrophic Scars of the Hand Caused by Burn Injury', '48 patients with a burn to their dominant right hand']","['ESWT', 'Extracorporeal Shock Wave Therapy', 'extracorporeal shock wave therapy (ESWT']","['scar vascularity', 'hand function', 'scar thickness', '10-point visual analogue scale pain score; Vancouver scar scale for scar vascularity, height, pliability and pigmentation; ultrasound measurement of scar thickness; Jebsen-Taylor hand function test; grip strength; Perdue pegboard test; and the Michigan hand outcomes questionnaire', 'pain score', 'pain, suppressing hypertrophic scarring']","[{'cui': 'C0162810', 'cui_str': 'Hypertrophic scar'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0006434', 'cui_str': 'Burn injury'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0230370', 'cui_str': 'Structure of right hand'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}]","[{'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0162810', 'cui_str': 'Hypertrophic scar'}]",48.0,0.0594385,"ESWT improved the pain score ( p  = 0.001), scar thickness ( p  = 0.018), scar vascularity ( p  = 0.0015), and improved hand function (simulated card-turning,  p  = 0.02; picking up small objects,  p  = 0.004).","[{'ForeName': 'So Young', 'Initials': 'SY', 'LastName': 'Joo', 'Affiliation': 'Department of Rehabilitation Medicine, Hangang Sacred Heart Hospital, College of Medicine Hallym University, Seoul 07247, Korea.'}, {'ForeName': 'Seung Yeol', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Medicine, Soonchunhyang University Hospital, Bucheon 14584, Korea.'}, {'ForeName': 'Yoon Soo', 'Initials': 'YS', 'LastName': 'Cho', 'Affiliation': 'Department of Rehabilitation Medicine, Hangang Sacred Heart Hospital, College of Medicine Hallym University, Seoul 07247, Korea.'}, {'ForeName': 'Cheong Hoon', 'Initials': 'CH', 'LastName': 'Seo', 'Affiliation': 'Department of Rehabilitation Medicine, Hangang Sacred Heart Hospital, College of Medicine Hallym University, Seoul 07247, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9051376']
155,32393980,Afternoon distraction: a high-saturated-fat meal and endotoxemia impact postmeal attention in a randomized crossover trial.,"BACKGROUND


Saturated-fat intake and endotoxemia can impair cognition. However, their acute impact on cognitive performance is unknown.
OBJECTIVE


This study assessed the impact of 2 high-fat meals and endotoxemia on attention.
METHODS


In this double-blind, randomized crossover trial, 51 women (n = 32 breast cancer survivors, n = 19 noncancer controls; mean ± SD age: 53 ± 8 y) completed the Continuous Performance Test (CPT) and had their blood drawn to assess endotoxemia markers LPS binding protein (LBP), soluble CD14 (sCD14), and the LBP to sCD14 ratio 1 h prior to eating either a high-saturated-fat meal or a high-oleic-sunflower-oil meal. Women again completed the CPT 5 h postmeal. At 1 to 4 wk later, women completed the same protocol but consumed the other meal.
RESULTS


In adjusted models, women had more difficulty distinguishing target stimuli from distractors after consuming the high-saturated-fat meal than they did after the oleic-sunflower-oil meal (B = 4.44, SE = 1.88, P = 0.02). Women with higher baseline LBP had less consistent response times (B = 0.002, SE = 0.0008, P = 0.04). Those with higher LBP and LBP:sCD14 were less able to sustain their attention throughout the entire CPT, as reflected by their progressively slower (B = 0.002, SE = 0.0006, P = 0.003; and B = 2.43, SE = 0.090, P = 0.008, respectively) and more erratic (B = 0.003, SE = 0.0008, P < 0.0001; and B = 3.29, SE = 1.17, P = 0.006, respectively) response times. Additionally, women with higher baseline LBP or sCD14 were less able to maintain or increase response speeds at higher interstimulus intervals (B = 0.002, SE = 0.0006, P = 0.02; and B = 0.006, SE = 0.003, P = 0.03, respectively), indicating greater difficulty adapting to changing task demands. Significant meal type by LBP and LBP:sCD14 interactions emerged (P < 0.05), such that high LBP and LBP:sCD14 erased between-meal cognitive differences, uniformly impairing performance.
CONCLUSIONS


These results suggest that higher LBP, sCD14, and LBP:sCD14 and saturated-fat intake individually and jointly influence attention. Endotoxemia may override the relative cognitive benefit of healthier oil choices.This trial is registered at clinicaltrials.gov as NCT04247763.",2020,"LBP had less consistent response times (B = 0.002, SE = 0.0008, P = 0.04).","['Women with higher baseline', '51 women (n\xa0=\xa032 breast cancer survivors, n\xa0=\xa019 noncancer controls; mean ± SD age: 53 ± 8 y']","['Afternoon distraction', 'LBP', 'Continuous Performance Test (CPT', 'LBP to sCD14 ratio 1 h prior to eating either a high-saturated-fat meal or a high-oleic-sunflower-oil meal']","['endotoxemia markers LPS binding protein (LBP), soluble CD14 (sCD14', 'cognitive performance']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0439550', 'cui_str': 'Afternoon'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0242210', 'cui_str': 'Binding protein'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0108768', 'cui_str': 'Lymphocyte antigen CD14'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0947381', 'cui_str': 'Helianthus annuus'}, {'cui': 'C0028908', 'cui_str': 'Oil'}]","[{'cui': 'C0376618', 'cui_str': 'Endotoxemia'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0242210', 'cui_str': 'Binding protein'}, {'cui': 'C0108768', 'cui_str': 'Lymphocyte antigen CD14'}]",51.0,0.151899,"LBP had less consistent response times (B = 0.002, SE = 0.0008, P = 0.04).","[{'ForeName': 'Annelise A', 'Initials': 'AA', 'LastName': 'Madison', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Martha A', 'Initials': 'MA', 'LastName': 'Belury', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Andridge', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'M Rosie', 'Initials': 'MR', 'LastName': 'Shrout', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Renna', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Malarkey', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Bailey', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Janice K', 'Initials': 'JK', 'LastName': 'Kiecolt-Glaser', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa085']
156,32384500,Multiple versus single doses of dexamethasone in total hip arthroplasty: A protocol of randomized controlled trial.,"BACKGROUND


Reduction of post-operative pain, nausea, and vomiting in patients undergoing total hip arthroplasty (THA) may facilitate earlier discharge from hospital and reduce healthcare costs. The recommended dose regimen of dexamethasone in THA has not been determined. The purpose of this study was performed to compare the efficiency of multiple versus single doses of dexamethasone for early postoperative pain treatment after THA.
METHODS


This study was a randomized controlled trial which conducted in our hospital. Informed consent for participation in this trial was obtained from each patient before surgery. Two hundred patients undergoing THA received 1 dose of intravenous dexamethasone and 1 dose of normal saline (Group A), or 2 doses of intravenous dexamethasone (Group B). The primary outcome was visual analog scale pain scores in the immediate postoperative period. Secondary outcomes included postoperative opioid use, length of hospital stay, activity level during physical therapy, and hip range of motion.
RESULTS


This clinical trial might provide some insights to estimate the safety of dexamethasone.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5460).",2020,"Secondary outcomes included postoperative opioid use, length of hospital stay, activity level during physical therapy, and hip range of motion.
","['Two hundred patients undergoing', 'early postoperative pain treatment after THA', 'patients undergoing total hip arthroplasty (THA', 'total hip arthroplasty']","['dexamethasone', 'normal saline', 'intravenous dexamethasone', 'THA']","['postoperative opioid use, length of hospital stay, activity level during physical therapy, and hip range of motion', 'visual analog scale pain scores']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0576002', 'cui_str': 'Hip joint - range of movement'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}]",200.0,0.478323,"Secondary outcomes included postoperative opioid use, length of hospital stay, activity level during physical therapy, and hip range of motion.
","[{'ForeName': 'Bangjian', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Shaoqiong', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'Department of Operation room, Panzhihua Central Hospital.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Sheng', 'Affiliation': 'Department of Anesthesiology, West China Second University Hospital, Sichuan University, Sichuan Province, China.'}]",Medicine,['10.1097/MD.0000000000020147']
157,32386747,Effect of immune regulatory pathways after immunization with GMZ2 malaria vaccine candidate in healthy lifelong malaria-exposed adults.,"BACKGROUND


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


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


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


Regulatory immune responses are induced following immunization. Stronger sHLA-G and Treg immune responses may suppress vaccine induced immune responses, and the magnitude of the sHLA-G response increased the risk of Plasmodium falciparum infection after CHMI. These findings could have implications for the design and testing of malaria vaccine candidates in semi-immune individuals.",2020,"The sHLA-G level on D84 was associated with a decrease of the anti-GMZ2 IgG concentration, whereas Treg frequencies on D0 or on D84, and Breg frequency on D84 were associated with lower plasmablast frequencies.","['Fifty Gabonese adults with lifelong exposure to Plasmodium spp', 'healthy lifelong malaria-exposed adults']","['30\xa0µg or 100\xa0µg GMZ2-CAF01, or 100\xa0µg GMZ2-alum, or control vaccine (rabies vaccine', 'GMZ2 malaria vaccine candidate']","['Vaccine efficacy', 'sHLA-G levels and anti-GMZ2 IgG concentrations', 'anti-GMZ2 IgG concentration', 'Only plasma and peripheral blood mononuclear cells', 'sHLA-G concentration', 'risk of P. falciparum infection']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4274169', 'cui_str': 'Lifelong'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0032148', 'cui_str': 'Plasmodium'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}]","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0051522', 'cui_str': 'aluminum sulfate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0034496', 'cui_str': 'Rabies vaccine'}, {'cui': 'C0206255', 'cui_str': 'Malarial Vaccines'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",35.0,0.0706217,"The sHLA-G level on D84 was associated with a decrease of the anti-GMZ2 IgG concentration, whereas Treg frequencies on D0 or on D84, and Breg frequency on D84 were associated with lower plasmablast frequencies.","[{'ForeName': 'Odilon', 'Initials': 'O', 'LastName': 'Nouatin', 'Affiliation': ""Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany; Germany; German Centre for Infection Research (DZIF), Partner Site Tübingen, Germany; Département de Biochimie et de Biologie Cellulaire, Faculté des Sciences et Techniques, Université d'Abomey-Calavi, Cotonou, Benin. Electronic address: paterneodilon@gmail.com.""}, {'ForeName': 'Ulysse', 'Initials': 'U', 'LastName': 'Ateba Ngoa', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon. Electronic address: ulyssus7000@gmail.com.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Ibáñez', 'Affiliation': 'Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany.'}, {'ForeName': 'Jean Claude', 'Initials': 'JC', 'LastName': 'Dejon-Agobe', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Mordmüller', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany; Germany; German Centre for Infection Research (DZIF), Partner Site Tübingen, Germany. Electronic address: benjamin.mordmueller@uni-tuebingen.de.'}, {'ForeName': 'Jean Ronald', 'Initials': 'JR', 'LastName': 'Edoa', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany. Electronic address: j.ronaldedoa@cermel.org.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Mougeni', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Brückner', 'Affiliation': 'Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany. Electronic address: sinab@gmx.net.'}, {'ForeName': 'Aurore', 'Initials': 'A', 'LastName': 'Bouyoukou Hounkpatin', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Esen', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany; Germany; German Centre for Infection Research (DZIF), Partner Site Tübingen, Germany. Electronic address: meral.esen@uni-tuebingen.de.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Theisen', 'Affiliation': 'Department for Congenital Disorders, Statens Serum Institut, Copenhagen, Denmark and Centre for Medical Parasitology at Department of International Health, Immunology and Microbiology, University of Copenhagen, and Department of Infectious Diseases, Copenhagen University Hospital, Rigshospitalet, Denmark. Electronic address: mth@ssi.dk.'}, {'ForeName': 'Kabirou', 'Initials': 'K', 'LastName': 'Moutairou', 'Affiliation': ""Département de Biochimie et de Biologie Cellulaire, Faculté des Sciences et Techniques, Université d'Abomey-Calavi, Cotonou, Benin. Electronic address: kamoutairo@yahoo.fr.""}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Hoffman', 'Affiliation': 'Sanaria Inc, Rockville, MD 20850, USA. Electronic address: slhoffman@sanaria.com.'}, {'ForeName': 'Saadou', 'Initials': 'S', 'LastName': 'Issifou', 'Affiliation': 'Fondation pour la Recherche Scientifique, 72 BP45 Cotonou, Benin. Electronic address: isaadou2002@yahoo.fr.'}, {'ForeName': 'Adrian J F', 'Initials': 'AJF', 'LastName': 'Luty', 'Affiliation': ""Centre d'Etude et de Recherche sur le Paludisme Associé à la Grossesse et à l'Enfance, Faculté des Sciences de la Santé, Université d'Abomey-Calavi, Cotonou, MERIT UMR D216, Benin; Université de Paris, MERIT, IRD, Paris, France. Electronic address: adrian.luty@ird.fr.""}, {'ForeName': 'Marguerite M', 'Initials': 'MM', 'LastName': 'Loembe', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany; Germany; German Centre for Infection Research (DZIF), Partner Site Tübingen, Germany. Electronic address: mmassingaloembe@cermel.org.'}, {'ForeName': 'Selidji Todagbé', 'Initials': 'ST', 'LastName': 'Agnandji', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany; Germany; German Centre for Infection Research (DZIF), Partner Site Tübingen, Germany. Electronic address: agnandjis@cermel.org.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Lell', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Department of Medicine I, Division of Infectious Diseases and Tropical Medicine, Medical University of Vienna, Vienna, Austria. Electronic address: bertrand.lell@cermel.org.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Kremsner', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany; Germany; German Centre for Infection Research (DZIF), Partner Site Tübingen, Germany. Electronic address: peter.kremsner@uni-tuebingen.de.'}, {'ForeName': 'Ayôla Akim', 'Initials': 'AA', 'LastName': 'Adegnika', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany; Germany; German Centre for Infection Research (DZIF), Partner Site Tübingen, Germany; Leiden University Medical Centre (LUMC), 2333 ZA Leiden, the Netherlands. Electronic address: aadegnika@cermel.org.'}]",Vaccine,['10.1016/j.vaccine.2020.04.046']
158,32388694,Supporting Infant Emotion Regulation Through Attachment-Based Intervention: a Randomized Controlled Trial.,"Infant emotion regulation has long-term implications for human development, highlighting the need for preventive interventions that support emotion regulation early in life. Such interventions may be especially important for infants higher in emotional reactivity who need to regulate their emotions more frequently and intensely than infants lower in emotional reactivity. The current randomized trial examined main and moderated effects of an attachment-based intervention on (a) infants' use of mother-oriented and self-soothing emotion regulation strategies and (b) infant emotion dysregulation in 186 low-income, predominantly Latino infants. We tested the brief (10-session) Attachment and Biobehavioral Catch-up (ABC) intervention in the context of home-based federal Early Head Start (EHS) services. Control participants received home-based EHS plus 10 weekly books. Intent-to-treat analyses with covariates revealed main effects of the intervention on infants' use of mother-oriented emotion regulation strategies during a brief (40-s) novel and potentially fear-inducing procedure (d = 0.31). Infant emotional reactivity moderated intervention impacts on mother-oriented emotion regulation strategies and on infant emotion dysregulation: We found stronger effects of the intervention for infants relatively higher in emotional reactivity. Findings are discussed in terms of the preventive value of attachment-based interventions for supporting early emotion regulation.",2020,Intent-to-treat analyses with covariates revealed main effects of the intervention on infants' use of mother-oriented emotion regulation strategies during a brief (40-s) novel and potentially fear-inducing procedure (d = 0.31).,"['186 low-income, predominantly Latino infants', 'infants relatively higher in emotional reactivity']","['home-based EHS plus 10 weekly books', 'attachment-based intervention', 'brief (10-session) Attachment and Biobehavioral Catch-up (ABC) intervention', 'mother-oriented and self-soothing emotion regulation strategies and (b) infant emotion dysregulation']",['infant emotion dysregulation'],"[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0231617', 'cui_str': 'Catch'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",186.0,0.0256925,Intent-to-treat analyses with covariates revealed main effects of the intervention on infants' use of mother-oriented emotion regulation strategies during a brief (40-s) novel and potentially fear-inducing procedure (d = 0.31).,"[{'ForeName': 'Allison D', 'Initials': 'AD', 'LastName': 'Hepworth', 'Affiliation': 'University of Maryland School of Social Work, 525 West Redwood St., Baltimore, MD, 21201, USA. allison.hepworth@ssw.umaryland.edu.'}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Berlin', 'Affiliation': 'University of Maryland School of Social Work, 525 West Redwood St., Baltimore, MD, 21201, USA.'}, {'ForeName': 'Tiffany L', 'Initials': 'TL', 'LastName': 'Martoccio', 'Affiliation': 'University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Erin N', 'Initials': 'EN', 'LastName': 'Cannon', 'Affiliation': 'University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Rebecca H', 'Initials': 'RH', 'LastName': 'Berger', 'Affiliation': 'University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Brenda Jones', 'Initials': 'BJ', 'LastName': 'Harden', 'Affiliation': 'University of Maryland, College Park, MD, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01127-1']
159,32332685,"Respiratory muscle training in stroke patients with respiratory muscle weakness, dysphagia, and dysarthria - a prospective randomized trial: Erratum.",,2020,,"['stroke patients with respiratory muscle weakness, dysphagia, and dysarthria ']",['Respiratory muscle training'],[],"[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1836141', 'cui_str': 'Respiratory muscle weakness'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0013362', 'cui_str': 'Dysarthria'}]","[{'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}]",[],,0.0313329,,[],Medicine,['10.1097/MD.0000000000020194']
160,32394723,"Effects of Depot Medroxyprogesterone Acetate, Copper Intrauterine Devices, and Levonorgestrel Implants on Early HIV Disease Progression.","Limited data exist on the effects of contraceptives on HIV disease progression. We studied the association between intramuscular injectable depot medroxyprogesterone acetate (DMPA-IM), the copper intrauterine device (IUD), and the levonorgestrel (LNG) implant on markers of HIV disease progression at the time of HIV detection and 3 months postdetection and time from detection to CD4 count <350 cells/mm 3 . Among women initiating antiretroviral therapy (ART), we studied the effect of contraceptive group on time from ART initiation to viral load (VL) <40 copies/mL. We included women 16-35 years randomized to DMPA-IM, copper IUD, or LNG implant with incident HIV infection during the Evidence for Contraceptive Options and HIV Outcomes (ECHO) trial ( n  = 382). We analyzed HIV VL and CD4 cell count according to participants' randomized method and also conducted a ""continuous use"" analysis that excluded follow-up time after method discontinuation. We used adjusted linear models to compare mean VL and CD4 cell levels by contraceptive group up to the time of ART initiation. We compared time from HIV detection to CD4 count <350 cells/mm 3  and, following ART initiation, time to viral suppression (VL <40 copies/mL) using Cox proportional hazards models. At HIV detection, women allocated to DMPA-IM had lower VL relative to copper IUD (-0.28 log 10  copies/mL; 95% confidence interval [CI]: -0.55 to -0.01) and LNG implant (-0.27, CI: -0.55 to 0.02) and higher mean CD4 than copper IUD users by 66 cells/mm 3  (CI: 11-121). In continuous use analyses women allocated to DMPA-IM progressed to CD4 < 350 cells/mm 3  slower than copper IUD users (hazard ratio [HR] = 0.6, CI: 0.3-1.1), whereas copper IUD users progressed faster than LNG implant users (HR = 1.8, CI: 1.0-3.3). Time to viral suppression was faster for DMPA-IM than copper IUD (HR = 1.5, CI: 1.0-2.3) and LNG implant 1.4 (CI: 0.9-2.2) users. We found no evidence of more rapid early HIV disease progression among women using DMPA-IM than among women using copper IUD or LNG implant. Our finding of more rapid progression among copper IUD compared with DMPA-IM users should be interpreted cautiously.",2020,"Women using DMPA-IM (HR= 0.6, CI: 0.3, 1.1) and LNG implant (HR = 0.6, CI: 0.3, 1.0) progressed to CD4 <350 slower than copper IUD users and time to viral suppression was faster for DMPA-IM than copper IUD (HR=1.5 (CI: 1.0, 2.3) and LNG implant 1.4 (CI: 0.9-2.2) users in continuous use analysis.
","['women using DMPA-IM', 'women 16-35 years randomized to']","['DMPA-IM, copper IUD, or levonorgestrel implant', 'DMPA-IM, the copper IUD and levonorgestrel (LNG) implant', 'depot medroxyprogesterone acetate, copper intrauterine devices, and levonorgestrel implants']","['mean viral load and CD4 cell levels', 'time to viral suppression', 'VL relative to copper IUD', 'HIV viral load and CD4 cell count', 'early HIV disease progression', 'time to CD4 count <350 cells/mm3 and viral suppression']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0067376', 'cui_str': 'N,N-dimethyl-4-anisidine'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0067376', 'cui_str': 'N,N-dimethyl-4-anisidine'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0015927', 'cui_str': 'Fetal death'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}, {'cui': 'C0021901', 'cui_str': 'Copper Intrauterine Devices'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0039215', 'cui_str': 'T lymphocyte positive for CD4 antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0015927', 'cui_str': 'Fetal death'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1141957', 'cui_str': 'HIV disease progression'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0439243', 'cui_str': 'uL'}]",382.0,0.424447,"Women using DMPA-IM (HR= 0.6, CI: 0.3, 1.1) and LNG implant (HR = 0.6, CI: 0.3, 1.0) progressed to CD4 <350 slower than copper IUD users and time to viral suppression was faster for DMPA-IM than copper IUD (HR=1.5 (CI: 1.0, 2.3) and LNG implant 1.4 (CI: 0.9-2.2) users in continuous use analysis.
","[{'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Morrison', 'Affiliation': 'FHI 360, Durham, North Carolina, USA.'}, {'ForeName': 'G Justus', 'Initials': 'GJ', 'LastName': 'Hofmeyr', 'Affiliation': 'Effective Care Research Unit, Department of Obstetrics and Gynaecology, University of Witwatersrand/Fort Hare/Walter Sisulu, East London, South Africa.'}, {'ForeName': 'Katherine K', 'Initials': 'KK', 'LastName': 'Thomas', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Rees', 'Affiliation': 'Wits Reproductive Health and HIV Institute (Wits RHI), University of Witswatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Neena', 'Initials': 'N', 'LastName': 'Philip', 'Affiliation': 'Mailman School of Public Health, ICAP at Columbia University, New York, USA.'}, {'ForeName': 'Thesla', 'Initials': 'T', 'LastName': 'Palanee-Phillips', 'Affiliation': 'Wits Reproductive Health and HIV Institute (Wits RHI), University of Witswatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Nanda', 'Affiliation': 'FHI 360, Durham, North Carolina, USA.'}, {'ForeName': 'Gonasagrie', 'Initials': 'G', 'LastName': 'Nair', 'Affiliation': 'Emavundleni Research Center, Capetown, South Africa.'}, {'ForeName': 'Maricianah', 'Initials': 'M', 'LastName': 'Onono', 'Affiliation': 'KEMRI-RCTP Study Center, Kisumu, Kenya.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Mastro', 'Affiliation': 'FHI 360, Durham, North Carolina, USA.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Lind', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, USA.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Heffron', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, USA.'}, {'ForeName': 'Vinodh', 'Initials': 'V', 'LastName': 'Edward', 'Affiliation': 'The Aurum Institute, Johannesburg, South Africa.'}, {'ForeName': 'Jen', 'Initials': 'J', 'LastName': 'Deese', 'Affiliation': 'FHI 360, Durham, North Carolina, USA.'}, {'ForeName': 'Mags', 'Initials': 'M', 'LastName': 'Beksinska', 'Affiliation': 'MatCH Research Unit (MRU), Faculty of Health Sciences, Department of Obstetrics and Gynecology, University of the Witwatersrand, Durban, South Africa.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Beesham', 'Affiliation': 'MatCH Research Unit (MRU), Faculty of Health Sciences, Department of Obstetrics and Gynecology, University of the Witwatersrand, Durban, South Africa.'}, {'ForeName': 'Jeffrey S A', 'Initials': 'JSA', 'LastName': 'Stringer', 'Affiliation': 'Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, USA.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, USA.'}, {'ForeName': 'Khatija', 'Initials': 'K', 'LastName': 'Ahmed', 'Affiliation': 'Setshaba Research Center, Soshanguve, South Africa.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",AIDS research and human retroviruses,['10.1089/AID.2020.0015']
161,32320845,Hybrid type 1 randomized controlled trial of a tablet-based application to improve quality of care in child mental health treatment.,"The quality of child mental health care is highly variable in community practice settings. Innovative technology-based solutions may be leveraged to improve quality of care and, in turn, treatment outcomes. This is a protocol paper that describes an innovative study design in which we rigorously evaluate the effectiveness of a tablet-assisted intervention, Supporting Providers and Reaching Kids (SPARK). SPARK consists of a collection of interactive games and activities that are designed to improve provider fidelity and child engagement in evidence-based psychotherapies. The methodology also allows us to explore the implementation and sustainability of a technology-enhanced intervention in more than two dozen community practice settings. This paper includes a description and justification for sample selection and recruitment procedures, selection of assessment measures and methods, design of the intervention, and statistical evaluation of critical outcomes. Novel features of the design include the tablet-based toolkit approach that has strong applicability to a range of child mental health interventions and the use of a hybrid type 1 effectiveness-implementation trial that allows for the simultaneous investigation of the effectiveness of the intervention and the implementation context. Challenges related to the implementation of a technology-enhanced intervention in existing mental health clinics are discussed, as well as implications for future research and practice.",2020,Novel features of the design include the tablet-based toolkit approach that has strong applicability to a range of child mental health interventions and the use of a hybrid type 1 effectiveness-implementation trial that allows for the simultaneous investigation of the effectiveness of the intervention and the implementation context.,['child mental health treatment'],['tablet-based application'],"['provider fidelity and child engagement', 'quality of care']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184647', 'cui_str': 'Mental health treatment'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}]",,0.040181,Novel features of the design include the tablet-based toolkit approach that has strong applicability to a range of child mental health interventions and the use of a hybrid type 1 effectiveness-implementation trial that allows for the simultaneous investigation of the effectiveness of the intervention and the implementation context.,"[{'ForeName': 'Margaret T', 'Initials': 'MT', 'LastName': 'Anton', 'Affiliation': 'Technology Applications Center for Healthful Lifestyles, College of Nursing, Medical University of South Carolina, 99 Jonathan Lucas St., MSC 160, Charleston, SC 29425, United States of America. Electronic address: antonm@musc.edu.'}, {'ForeName': 'Leigh E', 'Initials': 'LE', 'LastName': 'Ridings', 'Affiliation': 'Technology Applications Center for Healthful Lifestyles, College of Nursing, Medical University of South Carolina, 99 Jonathan Lucas St., MSC 160, Charleston, SC 29425, United States of America.'}, {'ForeName': 'Rochelle', 'Initials': 'R', 'LastName': 'Hanson', 'Affiliation': 'National Crime Victims Center, Department of Psychiatric and Behavioral Services, Medical University of South Carolina, 67 President Street, Charleston, SC 29425, United States of America.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Davidson', 'Affiliation': 'Technology Applications Center for Healthful Lifestyles, College of Nursing, Medical University of South Carolina, 99 Jonathan Lucas St., MSC 160, Charleston, SC 29425, United States of America.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Saunders', 'Affiliation': 'National Crime Victims Center, Department of Psychiatric and Behavioral Services, Medical University of South Carolina, 67 President Street, Charleston, SC 29425, United States of America.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Price', 'Affiliation': 'Department of Psychological Science, University of Vermont, John Dewey Hall, Rm 248, 2 Colchester Ave., Burlington, VM 05405, United States of America.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Kmett Danielson', 'Affiliation': 'National Crime Victims Center, Department of Psychiatric and Behavioral Services, Medical University of South Carolina, 67 President Street, Charleston, SC 29425, United States of America.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Chu', 'Affiliation': 'Graduate School of Applied and Professional Psychology, Rutgers University, 152 Frelinghuysen Rd., Piscataway, NJ 08854, United States of America.'}, {'ForeName': 'Clara E', 'Initials': 'CE', 'LastName': 'Dismuke', 'Affiliation': 'Health Economics Resource Center (HERC), VA Palo Alto Health Care System, 795 Willow Road (152-MPD), Menlo Park, CA 94025, United States of America.'}, {'ForeName': 'Zachary W', 'Initials': 'ZW', 'LastName': 'Adams', 'Affiliation': 'Department of Psychiatry, School of Medicine, Indiana University, 410 West 10th Street, Indianapolis, IN 46202, United States of America.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Ruggiero', 'Affiliation': 'Technology Applications Center for Healthful Lifestyles, College of Nursing, Medical University of South Carolina, 99 Jonathan Lucas St., MSC 160, Charleston, SC 29425, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106010']
162,32386922,Stability of acute responses to drugs in humans across repeated testing: Findings with alcohol and amphetamine.,"BACKGROUND


Controlled drug challenge studies provide valuable information about the acute behavioral effects of drugs, including individual differences that may affect risk for abuse. One question that arises in such studies is whether a single administration of a drug (and placebo) provides an accurate measure of response to the drug.
METHODS


Here, we examined data from two studies, one with alcohol and one with amphetamine, in which participants received two administrations of the drug and placebo. In this analysis we assess the stability of acute subjective and cardiovascular responses to the drugs across the two administrations. We examine i) systematic increases or decreases to the drugs from the first to the second administration, ii) test-retest reliability within individuals and iii) the accuracy of the acute drug responses to predict drug choice in a later session.
RESULTS


Responses were largely stable across sessions, although on the second session amphetamine ""liking"" was higher, and subjective responses to placebo including ""liking"" and ""want more"" decreased in both studies. Test-retest reliability within individuals was high. Responses during the first drug administration were as accurate in predicting drug choice as responses during both administrations combined.
CONCLUSIONS


Our findings indicate that a single administration of drug (and placebo) provides a good index of an individual's responses to alcohol or amphetamine, when participants are tested under controlled experimental conditions.",2020,"RESULTS


Responses were largely stable across sessions, although on the second session amphetamine ""liking"" was higher, and subjective responses to placebo including ""liking"" and ""want more"" decreased in both studies.",[],"['drug (and placebo', 'amphetamine', 'placebo']",['stability of acute subjective and cardiovascular responses'],[],"[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}]",,0.0465427,"RESULTS


Responses were largely stable across sessions, although on the second session amphetamine ""liking"" was higher, and subjective responses to placebo including ""liking"" and ""want more"" decreased in both studies.","[{'ForeName': 'Conor H', 'Initials': 'CH', 'LastName': 'Murray', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, 5841 S Maryland Ave MC3077, Chicago, IL 60637 USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Weafer', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, 5841 S Maryland Ave MC3077, Chicago, IL 60637 USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, 5841 S Maryland Ave MC3077, Chicago, IL 60637 USA. Electronic address: hdew@uchicago.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.107989']
163,32384663,"Efficacy of Commercially Available Nutritional Supplements: Analysis of Serum Uptake, Macular Pigment Optical Density and Visual Functional Response.","Purpose:  To compare the change in serum carotenoids, macular pigment optical density (MPOD) and visual function with the intake of two commercially available nutritional supplements.  Methods:  Participants were given a 24-week supply of a lipid-based micronized liquid medical food, Lumega-Z™ (LM), containing 28 mg of the macular carotenoids lutein (L), zeaxanthin (Z) and  meso -zeaxanthin (MZ), or given PreserVision™ AREDS 2 Formula (gel-caps; PV) containing 12 mg of the macular carotenoids L and Z, but no reported MZ. Serum levels of L, Z and MZ were obtained at baseline and after 12 weeks. Macular pigment optical densities (MPOD) and visual function were assessed at baseline and after 24 weeks.  Results:  Average blood serum concentrations of L, Z and MZ in the two groups at baseline were similar. The increases in L, Z and MZ were 0.434, 0.063 and 0.086 mol/L vs. 0.100, 0.043 and 0.001 mol/L, respectively, in the LM vs. PV group. From baseline to week 24, average MPOD in the LM-group increased by 0.064 from 0.418 to 0.482, whereas in the PV-group, it was essentially unchanged (0.461 to 0.459;). Although log-contrast sensitivity was improved in all groups under three conditions (photopic, mesopic and mesopic with glare), the change in log-contrast sensitivity was not statistically significant . Conclusion:  Despite only a 2.3-fold higher carotenoid concentration than PV, LM supplementation provides approximately 3-4-fold higher absorption, which leads to a significant elevation of MPOD levels.",2020,"The increases in L, Z and MZ were 0.434, 0.063 and 0.086 mol/L vs. 0.100, 0.043 and 0.001 mol/L, respectively, in the LM vs. PV group.",[],"['lipid-based micronized liquid medical food, Lumega-Z™ (LM), containing 28 mg of the macular carotenoids lutein (L), zeaxanthin (Z) and  meso -zeaxanthin (MZ), or given PreserVision™ AREDS 2 Formula (gel-caps; PV) containing 12 mg of the macular carotenoids L and Z, but no reported MZ', 'Commercially Available Nutritional Supplements']","['Average blood serum concentrations of L, Z and MZ', 'Serum Uptake, Macular Pigment Optical Density and Visual Functional Response', 'Serum levels of L, Z and MZ', 'MPOD levels', 'average MPOD', 'carotenoid concentration', 'serum carotenoids, macular pigment optical density (MPOD) and visual function', 'Macular pigment optical densities (MPOD) and visual function', 'log-contrast sensitivity']",[],"[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C2927194', 'cui_str': 'Medical food'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0303444', 'cui_str': 'Magnesium-28'}, {'cui': 'C0007271', 'cui_str': 'Carotinoid'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0078752', 'cui_str': 'zeaxanthin'}, {'cui': 'C3884591', 'cui_str': 'meso-zeaxanthin'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C2586580', 'cui_str': 'PreserVision'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C3850163', 'cui_str': 'Macular Pigment'}, {'cui': 'C0439164', 'cui_str': 'OD units'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0398595', 'cui_str': 'Myeloperoxidase deficiency'}, {'cui': 'C0007271', 'cui_str': 'Carotinoid'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}]",,0.0553229,"The increases in L, Z and MZ were 0.434, 0.063 and 0.086 mol/L vs. 0.100, 0.043 and 0.001 mol/L, respectively, in the LM vs. PV group.","[{'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Bone', 'Affiliation': 'College of Arts, Science and Education, Florida International University, Miami, FL 33199, USA.'}, {'ForeName': 'Pinakin Gunvant', 'Initials': 'PG', 'LastName': 'Davey', 'Affiliation': 'College of Optometry, Western University of Health Sciences, Pomona, CA 91766, USA.'}, {'ForeName': 'Betzabe O', 'Initials': 'BO', 'LastName': 'Roman', 'Affiliation': 'College of Arts, Science and Education, Florida International University, Miami, FL 33199, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Evans', 'Affiliation': 'Guardion Health Sciences Inc, San Diego, CA 92128, USA.'}]",Nutrients,['10.3390/nu12051321']
164,32386772,Underrepresentation of Women in Cardiovascular Randomized Clinical Trials.,,2020,,[],[],[],[],[],[],,0.29109,,"[{'ForeName': 'Nariman', 'Initials': 'N', 'LastName': 'Sepehrvand', 'Affiliation': ''}, {'ForeName': 'Wendimagegn', 'Initials': 'W', 'LastName': 'Alemayehu', 'Affiliation': ''}, {'ForeName': 'Debraj', 'Initials': 'D', 'LastName': 'Das', 'Affiliation': ''}, {'ForeName': 'Pishoy', 'Initials': 'P', 'LastName': 'Gouda', 'Affiliation': ''}, {'ForeName': 'Justin A', 'Initials': 'JA', 'LastName': 'Ezekowitz', 'Affiliation': ''}]",The Canadian journal of cardiology,['10.1016/j.cjca.2019.12.030']
165,32388584,Enteric-coated sodium bicarbonate supplementation improves high-intensity cycling performance in trained cyclists.,"PURPOSE


Enteric-coated sodium bicarbonate (NaHCO 3 ) can attenuate gastrointestinal (GI) symptoms following acute bicarbonate loading, although the subsequent effects on exercise performance have not been investigated. The purpose of this study was to examine the effects of enteric-coated NaHCO 3  supplementation on high-intensity exercise performance and GI symptoms.
METHODS


Eleven trained male cyclists completed three 4 km time trials after consuming; a placebo or 0.3 g∙kg -1  body mass NaHCO 3  in enteric-coated or gelatin capsules. Exercise trials were timed with individual peak blood bicarbonate ion concentration ([HCO 3 - ]). Blood acid-base balance was measured pre-ingestion, pre-exercise, and post-exercise, whereas GI symptoms were recorded pre-ingestion and immediately pre-exercise.
RESULTS


Pre-exercise blood [HCO3 - ] and potential hydrogen (pH) were greater for both NaHCO 3  conditions (P < 0.0005) when compared to placebo. Performance time was faster with enteric-coated (- 8.5 ± 9.6 s, P = 0.044) and gelatin (- 9.6 ± 7.2 s, P = 0.004) NaHCO 3  compared to placebo, with no significant difference between conditions (mean difference = 1.1 ± 5.3 s, P = 1.000). Physiological responses were similar between conditions, although blood lactate ion concentration was higher with gelatin NaHCO 3  (2.4 ± 1.7 mmol∙L -1 , P = 0.003) compared with placebo. Furthermore, fewer participants experienced GI symptoms with enteric-coated (n = 3) compared to gelatin (n = 7) NaHCO 3 .
DISCUSSION


Acute enteric-coated NaHCO 3  consumption mitigates GI symptoms at the onset of exercise and improves subsequent 4 km cycling TT performance. Athletes who experience GI side-effects after acute bicarbonate loading may, therefore, benefit from enteric-coated NaHCO 3  supplementation prior to exercise performance.",2020,"NaHCO 3  compared to placebo, with no significant difference between conditions (mean difference = 1.1 ± 5.3 s, P = 1.000).","['trained cyclists', 'Eleven trained male cyclists completed three 4\xa0km time trials after consuming; a']","['placebo or 0.3\xa0g∙kg -1  body mass NaHCO 3  in enteric-coated or gelatin capsules', 'enteric-coated NaHCO 3  supplementation', 'sodium bicarbonate (NaHCO 3 ', 'gelatin', 'Enteric-coated sodium bicarbonate supplementation', 'placebo']","['Blood acid-base balance', 'Pre-exercise blood [HCO3 - ] and potential hydrogen (pH', 'high-intensity exercise performance and GI symptoms', 'high-intensity cycling performance', 'Performance time', 'GI symptoms', 'Physiological responses', 'blood lactate ion concentration']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0017237', 'cui_str': 'Gelatin'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0001117', 'cui_str': 'Acid-base equilibrium'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0022023', 'cui_str': 'Ions'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",11.0,0.268481,"NaHCO 3  compared to placebo, with no significant difference between conditions (mean difference = 1.1 ± 5.3 s, P = 1.000).","[{'ForeName': 'Nathan Philip', 'Initials': 'NP', 'LastName': 'Hilton', 'Affiliation': 'Department of Sport and Physical Activity, Sports Nutrition and Performance Research Group, Edge Hill University, St Helens Road, Ormskirk, L39 4QP, UK. hiltonn@edgehill.ac.uk.'}, {'ForeName': 'Nicholas Keith', 'Initials': 'NK', 'LastName': 'Leach', 'Affiliation': 'Department of Sport and Physical Activity, Sports Nutrition and Performance Research Group, Edge Hill University, St Helens Road, Ormskirk, L39 4QP, UK.'}, {'ForeName': 'Melissa May', 'Initials': 'MM', 'LastName': 'Hilton', 'Affiliation': 'Therapies Department, Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'S Andy', 'Initials': 'SA', 'LastName': 'Sparks', 'Affiliation': 'Department of Sport and Physical Activity, Sports Nutrition and Performance Research Group, Edge Hill University, St Helens Road, Ormskirk, L39 4QP, UK.'}, {'ForeName': 'Lars Robert', 'Initials': 'LR', 'LastName': 'McNaughton', 'Affiliation': 'Department of Sport and Physical Activity, Sports Nutrition and Performance Research Group, Edge Hill University, St Helens Road, Ormskirk, L39 4QP, UK.'}]",European journal of applied physiology,['10.1007/s00421-020-04387-5']
166,32390099,"Reply to: Commentary to Josef Tacke, et al. The Randomized Freeway Stent Study: Drug-Eluting Balloons Outperform Standard Balloon Angioplasty for Postdilatation of Nitinol Stents in the SFA and PI Segment.",,2020,,[],['Drug-Eluting Balloons Outperform Standard Balloon Angioplasty'],[],[],"[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002996', 'cui_str': 'Balloon Angioplasty'}]",[],,0.0218828,,"[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Lammer', 'Affiliation': 'Department of Cardiovascular and Interventional Radiology, Medical University Vienna, Gebirgsgasse 26, 1230, Vienna, Austria. johannes.lammer@meduniwien.ac.at.'}]",Cardiovascular and interventional radiology,['10.1007/s00270-020-02464-y']
167,32390102,"Yes, I can - maybe … Effects of placebo-related instructions on neuroregulation in children with ADHD.","Neurofeedback training (NFT) provides strategies for children with ADHD to achieve changes on the neurophysiological and behavioral level to attenuate ADHD symptoms. We assume self-efficacy (an ""active attitude""), a core variable in successful NFT. In a randomized, double-blind controlled study, we investigated the impact of a ""placebo instruction"" on the EEG-regulation performance during two sessions of Theta-Beta-NFT in children with ADHD (age 8-12 years). Children receiving the information ""this might be a placebo-training"" showed inferior neuroregulation (n = 10) compared to children receiving a standard instruction (n = 12). Results of our pilot study are discussed in view of factors necessary for a valid training (ensuring maximal self-efficacy in the participants) and the fidelity of placebo-controlled trials in NFT-research.",2020,"Children receiving the information ""this might be a placebo-training"" showed inferior neuroregulation (n = 10) compared to children receiving a standard instruction (n = 12).","['children with ADHD', 'children with ADHD (age 8-12\xa0years']","['Theta-Beta-NFT', 'standard instruction', 'placebo instruction', 'Neurofeedback training (NFT', 'placebo-related instructions']",['EEG-regulation performance'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]","[{'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0220905', 'cui_str': 'regulations'}]",,0.224866,"Children receiving the information ""this might be a placebo-training"" showed inferior neuroregulation (n = 10) compared to children receiving a standard instruction (n = 12).","[{'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Gevensleben', 'Affiliation': 'Clinic for Child and Adolescent Psychiatry and Psychotherapy, University Medical Center Göttingen, von-Siebold-Str. 5, D37075, Goettingen, Germany. hgevens@gwdg.de.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schmiedeke', 'Affiliation': 'Clinic for Child and Adolescent Psychiatry and Psychotherapy, University Medical Center Göttingen, von-Siebold-Str. 5, D37075, Goettingen, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Heinrich', 'Affiliation': 'NeuroCare Group, Munich, Germany.'}, {'ForeName': 'Aribert', 'Initials': 'A', 'LastName': 'Rothenberger', 'Affiliation': 'Clinic for Child and Adolescent Psychiatry and Psychotherapy, University Medical Center Göttingen, von-Siebold-Str. 5, D37075, Goettingen, Germany.'}]","Journal of neural transmission (Vienna, Austria : 1996)",['10.1007/s00702-020-02193-z']
168,32330522,A transcriptional blood signature distinguishes early tuberculosis disease from latent tuberculosis infection and uninfected individuals in a Vietnamese cohort.,"OBJECTIVES


Global tuberculosis (TB) control is restricted by the failure to detect an estimated 3.3 million TB cases annually. In the majority of TB endemic settings, sputum smear microscopy is used to diagnose TB, but this test is insensitive for TB in its early stages. The objective of this study is to establish a concise gene signature that discriminates between individuals with early TB disease, latent TB infection (LTBI) and those without infection.
METHODS


This is a case control study nested within a cluster-randomised trial of population screening for active TB using Xpert MTB/RIF. Whole blood samples from 303 participants with active TB (97), LTBI (92) and uninfected individuals (114) were subject to transcriptomic analysis of selected target genes based on a systematic review of previous studies.
RESULTS


Analysis of 82 genes identified a pattern of differentially expressed genes in TB disease. A seven gene signature was identified that distinguished between TB disease and no TB disease with an AUC of 0.86 (95% CI: 0.80-0.91), and between TB disease from LTBI with an AUC of 0.88 (95% CI: 0.82-0.93).
CONCLUSION


This gene signature accurately distinguishes early TB disease from those without TB disease or infection, in the context of community-wide TB screening. It could be used as a non-sputum based screening tool or triage test to detect prevalent cases of TB in the community.",2020,"A seven gene signature was identified that distinguished between TB disease and no TB disease with an AUC of 0.86 (95% CI: 0.80-0.91), and between TB disease from LTBI with an AUC of 0.88 (95% CI: 0.82-0.93).
","['population screening for active TB using Xpert MTB/RIF', 'individuals with early TB disease, latent TB infection (LTBI) and those without infection', '303 participants with active TB (97), LTBI (92) and uninfected individuals (114']",[],[],"[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0026926', 'cui_str': 'Mycobacterium tuberculosis'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1609538', 'cui_str': 'Inactive tuberculosis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C4708785', 'cui_str': '114'}]",[],[],303.0,0.242559,"A seven gene signature was identified that distinguished between TB disease and no TB disease with an AUC of 0.86 (95% CI: 0.80-0.91), and between TB disease from LTBI with an AUC of 0.88 (95% CI: 0.82-0.93).
","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Ho', 'Affiliation': 'Woolcock Institute of Medical Research, The University of Sydney, 431 Glebe Point Rd, Glebe NSW 2037, Australia; South Western Sydney Clinical School, University of New South Wales, Sydney, Australia; Centenary Institute, The University of Sydney, Sydney, Australia. Electronic address: jennifer.ho@sydney.edu.au.'}, {'ForeName': 'Nilesh J', 'Initials': 'NJ', 'LastName': 'Bokil', 'Affiliation': 'School of Life Sciences, University of Technology Sydney, Sydney, Australia.'}, {'ForeName': 'Phuong Thi Bich', 'Initials': 'PTB', 'LastName': 'Nguyen', 'Affiliation': 'Woolcock Institute of Medical Research, The University of Sydney, 431 Glebe Point Rd, Glebe NSW 2037, Australia.'}, {'ForeName': 'Thu Anh', 'Initials': 'TA', 'LastName': 'Nguyen', 'Affiliation': 'Woolcock Institute of Medical Research, The University of Sydney, 431 Glebe Point Rd, Glebe NSW 2037, Australia.'}, {'ForeName': 'Michael Y', 'Initials': 'MY', 'LastName': 'Liu', 'Affiliation': 'The ithree Institute, University of Technology Sydney, Sydney, Australia.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Hare', 'Affiliation': 'Centenary Institute, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Greg J', 'Initials': 'GJ', 'LastName': 'Fox', 'Affiliation': 'Woolcock Institute of Medical Research, The University of Sydney, 431 Glebe Point Rd, Glebe NSW 2037, Australia; Central Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Bernadette M', 'Initials': 'BM', 'LastName': 'Saunders', 'Affiliation': 'Centenary Institute, The University of Sydney, Sydney, Australia; School of Life Sciences, University of Technology Sydney, Sydney, Australia.'}, {'ForeName': 'Guy B', 'Initials': 'GB', 'LastName': 'Marks', 'Affiliation': 'Woolcock Institute of Medical Research, The University of Sydney, 431 Glebe Point Rd, Glebe NSW 2037, Australia; South Western Sydney Clinical School, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Warwick J', 'Initials': 'WJ', 'LastName': 'Britton', 'Affiliation': 'Centenary Institute, The University of Sydney, Sydney, Australia; Central Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.'}]",The Journal of infection,['10.1016/j.jinf.2020.03.066']
169,32389808,Rationale and study design for lifestyle intervention in preparation for pregnancy (LIPP): A randomized controlled trial.,"INTRODUCTION


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


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


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


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


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


NCT03146156.",2020,"Findings may change standard obstetrical care by providing Level 1 evidence on lifestyle interventions improving neonatal outcomes for women planning for pregnancy.
","['pregnancy (LIPP', 'Overweight/class 1 obese women after a previous pregnancy, ~12', 'women planning for pregnancy']","['LIPP', 'lifestyle intervention']","['umbilical cord blood insulin resistance, lipid profile and inflammation', 'maternal pregravid and gestational body composition, insulin sensitivity, β-cell function, fasting metabolic and inflammatory biomarkers, and overall quality of life', 'utero metabolic milieu', 'neonatal adiposity at birth assessed by PEA POD and placental mitochondrial lipid metabolism']","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0600457', 'cui_str': 'Gravida'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0030738', 'cui_str': 'Peas'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}]",1.0,0.119724,"Findings may change standard obstetrical care by providing Level 1 evidence on lifestyle interventions improving neonatal outcomes for women planning for pregnancy.
","[{'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Erickson', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America; Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America.'}, {'ForeName': 'J T', 'Initials': 'JT', 'LastName': 'Mey', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America; Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Axelrod', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America; Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America; Department of Translational Services, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Paul', 'Affiliation': 'Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Gordesky', 'Affiliation': 'Department of Reproductive Biology, Center for Reproductive Health, MetroHealth Medical, 2500 MetroHealth Dr, Cleveland, OH 44109, United States of America.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Russell', 'Affiliation': 'Mother Infant Research Institute, Tufts Medical Center, 800 Washington St, Boston, MA 02111, United States of America.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Barkoukis', 'Affiliation': 'Department of Nutrition, Case Western Reserve University, 10900 Euclid Ave, Cleveland, OH 44106, United States of America.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': ""O'Tierney-Ginn"", 'Affiliation': 'Department of Reproductive Biology, Center for Reproductive Health, MetroHealth Medical, 2500 MetroHealth Dr, Cleveland, OH 44109, United States of America; Mother Infant Research Institute, Tufts Medical Center, 800 Washington St, Boston, MA 02111, United States of America.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Fielding', 'Affiliation': 'Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, 711 Washington St, Boston, MA 02111, United States of America.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Kirwan', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America; Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America. Electronic address: John.Kirwan@pbrc.edu.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Catalano', 'Affiliation': 'Department of Reproductive Biology, Center for Reproductive Health, MetroHealth Medical, 2500 MetroHealth Dr, Cleveland, OH 44109, United States of America; Mother Infant Research Institute, Tufts Medical Center, 800 Washington St, Boston, MA 02111, United States of America. Electronic address: pcatalano@tuftsmedicalcenter.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106024']
170,32332634,Clinical study for external washing by traditional Chinese medicine in the treatment of multiple infectious wounds of diabetic foot: Study protocol clinical trial (SPIRIT compliant).,"BACKGROUND


Diabetic foot (DF) is among the most serious complications of type 2 diabetes. DF infection (DFI) is a key factor in the deterioration and development of DF, so controlling infection plays an important role in the treatment of the disease. Traditional Chinese medicine foot bath has been widely used in China as a complementary and alternative therapy to improve circulation and infection control of DF. However, the existing evidence shows that its efficacy and safety are still insufficient. We report a study protocol about a multicenter, double-blind, randomized, placebo controlled trial which aims to make well-designed clinical trials to evaluate the efficacy and safety of herbal medicine foot bath decoction (FBD) and explore the mechanism of external washing of Chinese herbs in DFI.
METHODS


This study is a multicenter, double-blind, randomized, placebo controlled clinical trial in which 60 eligible participants were randomly divided into an experimental group and control group at a 1:2 ratio. Both groups received the same basic treatment for DF disease, the experimental group used FBD and ordinary dressing changes, while half of the patients in the control group received placebo and ordinary dressings, and the other half received placebo and silver ion dressings. Patients in both groups will be evaluated weekly for efficacy during the intervention. The primary efficacy indicators include the types of wound pathogens, interleukin 6 and tumor necrosis factor α. Secondary efficacy indicators included blood glucose, blood lipids, wound area, lower extremity blood vessel diameter, blood flow speed, walking speed, walking distance, and traditional Chinese medicine syndrome scores. We will also conduct a safety evaluation of the drug at the end of the trial.
DISCUSSION


This multicenter, double-blind, randomized, placebo clinical trial not only provides data on the efficacy and safety of FBD, but also provides a novel treatment strategy for clinicians and DF patients.",2020,"The primary efficacy indicators include the types of wound pathogens, interleukin 6 and tumor necrosis factor α. Secondary efficacy indicators included blood glucose, blood lipids, wound area, lower extremity blood vessel diameter, blood flow speed, walking speed, walking distance, and traditional Chinese medicine syndrome scores.","['multiple infectious wounds of diabetic foot', '60 eligible participants', 'clinicians and DF patients']","['external washing by traditional Chinese medicine', 'placebo and ordinary dressings, and the other half received placebo and silver ion dressings', 'placebo', 'herbal medicine foot bath decoction (FBD']","['types of wound pathogens, interleukin 6 and tumor necrosis factor α. Secondary efficacy indicators included blood glucose, blood lipids, wound area, lower extremity blood vessel diameter, blood flow speed, walking speed, walking distance, and traditional Chinese medicine syndrome scores', 'efficacy and safety of FBD']","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0206172', 'cui_str': 'Diabetic foot'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0037125', 'cui_str': 'silver'}, {'cui': 'C0022023', 'cui_str': 'Ions'}, {'cui': 'C0025125', 'cui_str': 'Herbs, Medicinal'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}]","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}]",60.0,0.305234,"The primary efficacy indicators include the types of wound pathogens, interleukin 6 and tumor necrosis factor α. Secondary efficacy indicators included blood glucose, blood lipids, wound area, lower extremity blood vessel diameter, blood flow speed, walking speed, walking distance, and traditional Chinese medicine syndrome scores.","[{'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Haipo', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Long', 'Affiliation': 'Neijiang Hospital of Traditional Chinese Medicine, Neijiang, Sichuan Province, P.R. China.'}, {'ForeName': 'Luguang', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Chunguang', 'Initials': 'C', 'LastName': 'Xie', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Guangming', 'Initials': 'G', 'LastName': 'Gong', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}]",Medicine,['10.1097/MD.0000000000019841']
171,32394478,"Pain reduction realized with extracorporeal shock wave therapy for the treatment of symptoms associated with interstitial cystitis/bladder pain syndrome-A prospective, multicenter, randomized, double-blind, placebo-controlled study.","AIMS


Extracorporeal shock wave therapy (ESWT) inhibited bladder inflammation and pain in preclinical studies. We assessed ESWT for the treatment of refractory interstitial cystitis/bladder pain syndrome (IC/BPS).
METHODS


This double-blind, randomized, placebo-controlled physician-initiated study enrolled 54 patients with IC/BPS. The patients were assigned to ESWT (N = 24; 2000 shocks, frequency of 3 Hz, and maximum total energy flow density 0.25 mJ/mm 2  ) once a week for 4 weeks at suprapubic bladder area or placebo (N = 25; shock wave setting without energy transmission). The primary endpoint was the average changes in O'Leary-Sant symptom scores (OSS) between baseline and 4 weeks after treatment. Secondary endpoints included visual analog scale (VAS, 0-10) for pain, the average changes of variables in a 3-day voiding diary, and global response assessment of patient satisfaction.
RESULTS


At 4 weeks posttreatment, both groups were associated with a statistically significant decrease in OSS and VAS pain scale. However, there were no difference in mean change between ESWT vs placebo groups. A significantly higher proportion of patients on ESWT responded as improved in the VAS ≥ 3 vs placebo (P = .035). At 12 weeks posttreatment, improvement in the VAS ≥ 3 was 57.1% vs 19.0% (ESWT vs placebo; P = .011). The finding was associated with an improvement in frequency - 1.0 ± 2.3 vs 0.7 ± 3.2 (ESWT vs placebo; P = .065). No significant adverse events were found in either group.
CONCLUSIONS


A reduction in pain was discovered in this trial assessing ESWT in patients with IC/BPS but OSS, which was the primary outcome parameter, was not improved.",2020,"No significant adverse events were found in either group.
","['54 patients with IC/BPS', 'symptoms associated with interstitial cystitis/bladder pain syndrome', 'refractory interstitial cystitis/bladder pain syndrome (IC/BPS']","['extracorporeal shock wave therapy', 'Extracorporeal shock wave therapy (ESWT', 'ESWT', 'ESWT vs placebo', 'placebo']","[""average changes in O'Leary-Sant symptom scores (OSS"", 'VAS\u2009≥', 'adverse events', 'pain', 'visual analog scale (VAS, 0-10) for pain, the average changes of variables in a 3-day voiding diary, and global response assessment of patient satisfaction', 'OSS and VAS pain scale', 'Pain reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282488', 'cui_str': 'Ulcerative cystitis'}, {'cui': 'C1720830', 'cui_str': 'Bladder Pain Syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449206', 'cui_str': 'OSS'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",54.0,0.673396,"No significant adverse events were found in either group.
","[{'ForeName': 'Yao-Chi', 'Initials': 'YC', 'LastName': 'Chuang', 'Affiliation': 'Department of Urology, Center for Shockwave Medicine and Tissue Engineering, Kaohsiung Chang Gung Memorial Hospital, College of Medicine, Chang Gung University, Taoyuan City, Taiwan.'}, {'ForeName': 'En', 'Initials': 'E', 'LastName': 'Meng', 'Affiliation': 'Division of Urology, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Chancellor', 'Affiliation': 'Department of urology, Oakland University William Beaumont School of Medicine, Royal Oak, Michigan.'}, {'ForeName': 'Hann-Chorng', 'Initials': 'HC', 'LastName': 'Kuo', 'Affiliation': 'Department of Urology, Hualien Tzu Chi General Hospital, Tzu Chi Medical Foundation, Buddhist Tzu Chi University, Hualien, Taiwan.'}]",Neurourology and urodynamics,['10.1002/nau.24382']
172,32396017,"Effects of blackcurrant extract on arterial functions in older adults: A randomized, double-blind, placebo-controlled, crossover trial.","PURPOSE


Blackcurrant extract mainly contains anthocyanins. Several reports suggest that anthocyanins have beneficial effect for cardiovascular functions. The aim of this study was to examine the effect of 7-day intake of New Zealand blackcurrant (NZBC) extract on arterial functions, e.g. arterial stiffness, and serum lipids.
METHODS


A randomized, double-blind, placebo-controlled, crossover design study with a washout period of 28 days was conducted. Fourteen older adults participated in this study (age 73.3 ± 1.7 years). Participants took either a 7-day course of placebo or two capsules of NZBC extract (each 300 mg capsule contains 35% blackcurrant extract). Participants took one of the two trials first and then took the other after a washout period. Carotid-femoral pulse-wave velocity, an index of central arterial stiffness, and central blood pressure were measured at baseline and again at the end of the 7-day study period.
RESULTS


Compared to baseline, carotid-femoral pulse-wave velocity ( P  = .03) and central blood pressure ( P  = .02) decreased significantly after the 7-day study period with NZBC intake. In addition, carotid-femoral pulse-wave velocity ( P  = .04) and central blood pressure ( P  = .001) in the NZBC intake trial decreased significantly more than in the placebo intake trial. No effects were observed on serum lipids.
CONCLUSION


These results suggest that short-term NZBC intake reduces central arterial stiffness and central blood pressure in older adults. Therefore, anthocyanin-rich blackcurrants might be beneficial for maintaining or improving cardiovascular health as an alternative to pharmaceutical medications.
ABBREVIATIONS


Aix: augmentation index; BP: blood pressure; cfPWV: carotid-femoral pulse-wave velocity;  CVD: cardiovascular diseases; DBP: diastolic blood pressure;  faPWV: femoral-ankle pulse-wave velocity; FG: fasting glucose; HDL: high-density lipoprotein cholesterol; LDL: low-density lipoprotein cholesterol; MBP: mean blood pressure; NZBC: New Zealand blackcurrant; PP: pulse pressure; SBP: systolic blood pressure; TG: triglycerides.",2020,"Compared to baseline, carotid-femoral pulse-wave velocity ( P  = .03) and central blood pressure ( P  = .02) decreased significantly after the 7-day study period with NZBC intake.","['older adults', 'Fourteen older adults participated in this study (age 73.3\xa0±\xa01.7\xa0years', 'Abbreviations ']","['anthocyanins', 'Blackcurrant extract mainly contains anthocyanins', 'blackcurrant extract', 'New Zealand blackcurrant (NZBC) extract', 'placebo or two capsules of NZBC extract', 'NZBC intake', 'placebo']","['carotid-femoral pulse-wave velocity', 'Carotid-femoral pulse-wave velocity, an index of central arterial stiffness, and central blood pressure', 'central arterial stiffness and central blood pressure', 'arterial functions', 'serum lipids', 'arterial functions, e.g. arterial stiffness, and serum lipids', 'central blood pressure']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0000723', 'cui_str': 'Abbreviation'}]","[{'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C0453277', 'cui_str': 'Blackcurrants'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}]",14.0,0.385975,"Compared to baseline, carotid-femoral pulse-wave velocity ( P  = .03) and central blood pressure ( P  = .02) decreased significantly after the 7-day study period with NZBC intake.","[{'ForeName': 'Takanobu', 'Initials': 'T', 'LastName': 'Okamoto', 'Affiliation': 'Department of Exercise Physiology, Nippon Sport Science University , Tokyo, Japan.'}, {'ForeName': 'Yuto', 'Initials': 'Y', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Exercise Physiology, Nippon Sport Science University , Tokyo, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Kobayashi', 'Affiliation': 'Center for Fundamental Education, Teikyo University of Science , Tokyo, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Nakazato', 'Affiliation': 'Department of Exercise Physiology, Nippon Sport Science University , Tokyo, Japan.'}, {'ForeName': 'Mark Elisabeth Theodorus', 'Initials': 'MET', 'LastName': 'Willems', 'Affiliation': 'Institute of Sport, University of Chichester , Chichester, UK.'}]","Clinical and experimental hypertension (New York, N.Y. : 1993)",['10.1080/10641963.2020.1764015']
173,32397596,Acute Effects of a Single Football Training or Match on Passive Hip Rotation Range of Motion in Semi-Professional Football Players: A Pilot Study.,"BACKGROUND AND OBJECTIVES


The repetitive loading forces generated during football activities may induce alterations in the hip rotation range of motion (ROM) in players. The objective of this study was to evaluate the acute effects of a training and a match on bilateral passive hip rotation ROM in both lower limbs in soccer.
MATERIAL AND METHODS


Twenty-eight male players were divided into two groups: 14 players (28 limbs) with normal bilateral hip rotation ROM (NH group) and 14 players (28 limbs) with restricted bilateral hip ROM (RH group). Passive bilateral hip rotation ROM was measured, by goniometer, before and after training or a match. Internal-rotation ROM (ROM IR ), external-rotation ROM (ROM ER ), total ROM (ROM TOT ) and relative internal rotation (ROM REL ) were calculated.
RESULTS


The NH group did not show substantial changes in hip ROM after a training nor a match. After a training session, only the RH group exhibited a substantial increase in ROM IR , ROM ER  and ROM TOT . After a match, only the RH group exhibited a substantial increase in ROM ER  and ROM TOT  and exhibited a substantial decrease in ROM REL . Comparing both groups, there were significant differences within ROM changes for ROM ER  and ROM TOT  after training and for ROM ER  and ROM REL  after a match.
CONCLUSIONS


Despite the small sample size of the present study, the findings indicate that a single football activity leads to significant changes in hip rotation ROM in players with restricted bilateral hip external-rotation ROM. However, these changes did not reach reference cut-off scores.",2020,"Comparing both groups, there were significant differences within ROM changes for ROM ER  and ROM TOT  after training and for ROM ER  and ROM REL  after a match.
","['Semi-Professional Football Players', 'players with restricted bilateral hip external-rotation ROM', 'soccer', 'Twenty-eight male players were divided into two groups: 14 players (28 limbs) with']","['Single Football Training or Match', 'normal bilateral hip rotation ROM (NH group) and 14 players (28 limbs) with restricted bilateral hip ROM (RH group', 'training and a match on bilateral passive hip rotation ROM']","['ROM IR , ROM ER  and ROM TOT ', 'Internal-rotation ROM (ROM IR ), external-rotation ROM (ROM ER ), total ROM (ROM TOT ) and relative internal rotation (ROM REL ', 'hip ROM', 'Passive Hip Rotation Range of Motion', 'ROM changes for ROM ER  and ROM TOT  after training and for ROM ER  and ROM REL', 'ROM ER  and ROM TOT', 'ROM REL ', 'Passive bilateral hip rotation ROM', 'hip rotation ROM']","[{'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0576002', 'cui_str': 'Hip joint - range of movement'}]","[{'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0035018', 'cui_str': 'rel Oncogene'}, {'cui': 'C0576002', 'cui_str': 'Hip joint - range of movement'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]",28.0,0.0259294,"Comparing both groups, there were significant differences within ROM changes for ROM ER  and ROM TOT  after training and for ROM ER  and ROM REL  after a match.
","[{'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'De-la-Cruz-Torres', 'Affiliation': 'Department of Physiotherapy, University of Seville, Avicena Street, 41009 Seville, Spain.'}, {'ForeName': 'Vanesa', 'Initials': 'V', 'LastName': 'Abuín-Porras', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea, Villaviciosa de Odón, 28670 Madrid, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Blanco-Morales', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea, Villaviciosa de Odón, 28670 Madrid, Spain.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'de-la-Cueva-Reguera', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea, Villaviciosa de Odón, 28670 Madrid, Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Calvo-Lobo', 'Affiliation': 'Facultad de Enfermería, Fisioterapia y Podología, Universidad Complutense de Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'López-López', 'Affiliation': 'Research, Health and Podiatry Group, Department of Health Sciences, Faculty of Nursing and Podiatry, Universidade da Coruña, 15403 Ferrol, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Romero-Morales', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea, Villaviciosa de Odón, 28670 Madrid, Spain.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56050228']
174,32397609,Hydrolyzed Chicken Extract (ProBeptigen ® ) on Cognitive Function in Healthy Middle-Aged People: A Randomized Double-Blind Trial.,"Cognitive decline is an important issue of global public health. Cognitive aging might begin at middle adulthood, the period particularly vulnerable to stress in lifespan. Essence of chicken (EOC) has consistently demonstrated its beneficial effects on various cognitive domains as nutritional supplementation. This study primarily aimed to examine the cognitive enhancement effects of ProBeptigen® (previously named CMI-168), hydrolyzed peptides extracted from EOC, in healthy middle-aged people under mild stress. Ninety healthy subjects were randomly assigned into the ProBeptigen® or placebo group for eight weeks. Neurocognitive assessment, event-related potentials (ERPs), and blood tests were conducted before, during, and after the treatment. The ProBeptigen® group outperformed placebo group on Logical Memory subtests of Wechsler Memory Scale-third edition (WMS-III) and Spatial Working Memory task in the Cambridge Neuropsychological Test Automated Battery (CANTAB). The anti-inflammatory effects of ProBeptigen® in humans were also confirmed, with progressively declining high-sensitivity C-reactive protein (hs-CRP) levels. Regular dietary supplementation of ProBeptigen® is suggested to improve verbal short- and long-term memory as well as spatial working memory, and reduce inflammation in middle-aged healthy individuals with stress. The effects of ProBeptigen® on cognition warrant further investigation. (NCT03612752).",2020,The ProBeptigen® group outperformed placebo group on Logical Memory subtests of Wechsler Memory Scale-third edition (WMS-III) and Spatial Working Memory task in the Cambridge Neuropsychological Test Automated Battery (CANTAB).,"['Ninety healthy subjects', 'middle-aged healthy individuals with stress', 'Healthy Middle-Aged People', 'healthy middle-aged people under mild stress']","['chicken (EOC', 'ProBeptigen® or placebo', 'ProBeptigen®', 'Hydrolyzed Chicken Extract (ProBeptigen ® ', 'ProBeptigen® (previously named CMI-168), hydrolyzed peptides extracted from EOC', 'placebo']","['Cognitive Function', 'Logical Memory subtests of Wechsler Memory Scale-third edition (WMS-III) and Spatial Working Memory task', 'Neurocognitive assessment, event-related potentials (ERPs), and blood tests']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}]","[{'cui': 'C0008051', 'cui_str': 'Gallus gallus'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0451575', 'cui_str': 'Wechsler memory scale'}, {'cui': 'C0441796', 'cui_str': 'Third edition'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0282171', 'cui_str': 'Event-related potentials'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}]",90.0,0.166073,The ProBeptigen® group outperformed placebo group on Logical Memory subtests of Wechsler Memory Scale-third edition (WMS-III) and Spatial Working Memory task in the Cambridge Neuropsychological Test Automated Battery (CANTAB).,"[{'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, Shuang-Ho Hospital, Taipei Medical University, New Taipei 235, Taiwan.'}, {'ForeName': 'Cheng-Chang', 'Initials': 'CC', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, Shuang-Ho Hospital, Taipei Medical University, New Taipei 235, Taiwan.'}, {'ForeName': 'Kuan-Yu', 'Initials': 'KY', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Shuang-Ho Hospital, Taipei Medical University, New Taipei 235, Taiwan.'}, {'ForeName': 'Ying-Chin', 'Initials': 'YC', 'LastName': 'Lin', 'Affiliation': 'School of Medicine, College of Medicine, Taipei Medical University, Taipei 110, Taiwan.'}, {'ForeName': 'Pei-Jung', 'Initials': 'PJ', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, Shuang-Ho Hospital, Taipei Medical University, New Taipei 235, Taiwan.'}, {'ForeName': 'Pei-Hsiu', 'Initials': 'PH', 'LastName': 'Hsieh', 'Affiliation': 'Department of Neurology, Shuang-Ho Hospital, Taipei Medical University, New Taipei 235, Taiwan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Nakao', 'Affiliation': ""Research and Development, BRAND'S Suntory Asia, Singapore 138623, Singapore.""}, {'ForeName': 'Mandy Y L', 'Initials': 'MYL', 'LastName': 'Ow', 'Affiliation': ""Research and Development, BRAND'S Suntory Asia, Singapore 138623, Singapore.""}, {'ForeName': 'Yi-Chen', 'Initials': 'YC', 'LastName': 'Hsieh', 'Affiliation': 'PhD Program for Neural Regenerative Medicine, College of Medical Science and Technology, Taipei Medical University, Taipei 110, Taiwan.'}, {'ForeName': 'Chaur-Jong', 'Initials': 'CJ', 'LastName': 'Hu', 'Affiliation': 'Department of Neurology, Shuang-Ho Hospital, Taipei Medical University, New Taipei 235, Taiwan.'}]",Nutrients,['10.3390/nu12051362']
175,32334332,The effects of consecutive sessions of anodal transcranial direct current stimulation over the primary motor cortex on hand function in healthy older adults.,"BACKGROUND


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


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


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


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


The current findings suggest a-tDCS can be considered as a promising stand-alone technique in the intervention of the age-related decline of manual dexterity for improving hand function.",2020,"Compared to the sham group, the results indicated significant improvement in all PPT subtests (P < 0.05), except for PPTL at T1, PPT for both hands at T2 and PPT assembly at T3 in a-tDCS group.
","['32 participants received', 'healthy older adults']","['multi session anodal transcranial Direct Current Stimulation (a-tDCS', 'active or sham a-tDCS', 'anodal transcranial direct current stimulation']","['PPT', 'PPT subtests']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0204462', 'cui_str': 'Purdue pegboard test'}]",32.0,0.0611213,"Compared to the sham group, the results indicated significant improvement in all PPT subtests (P < 0.05), except for PPTL at T1, PPT for both hands at T2 and PPT assembly at T3 in a-tDCS group.
","[{'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Rostami', 'Affiliation': 'Research Center on Aging, Department of Physiotherapy, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mosallanezhad', 'Affiliation': 'Research Center on Aging, Department of Physiotherapy, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran. Electronic address: zmosallanezhad@yahoo.com.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Ansari', 'Affiliation': 'Musculoskeletal Rehabilitation Research Center, Speech Therapy Department, Ahvaz Jundishapur University of Medical Science, Ahvaz, Iran.'}, {'ForeName': 'Dawson', 'Initials': 'D', 'LastName': 'Kidgell', 'Affiliation': 'Department of Physiotherapy, School of Primary Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Tahere', 'Initials': 'T', 'LastName': 'Rezaeian', 'Affiliation': 'Research Center on Aging, Department of Physiotherapy, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Enayatollah', 'Initials': 'E', 'LastName': 'Bakhshi', 'Affiliation': 'Department of Biostatistics, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Ghodrati', 'Affiliation': 'Health and Rehabilitation Sciences Program, University of Western Ontario, London, Canada.'}, {'ForeName': 'Shapour', 'Initials': 'S', 'LastName': 'Jaberzadeh', 'Affiliation': 'Department of Physiotherapy, School of Primary Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104063']
176,32392882,"The Preventive role of Regular Physical Training in Ventricular Remodeling, Serum Cardiac Markers, and Exercise Performance Changes in Breast Cancer in Women Undergoing Trastuzumab Therapy-An REH-HER Study.","Cardiotoxicity is known as a severe clinical problem in oncological practice that reduces the options for cancer therapy. Physical exercise is recognized as a well-established protective measure for many heart and cancer diseases. In our study, we hypothesized that supervised and moderate-intensity exercise training would prevent heart failure and its consequences induced by trastuzumab therapy. The aim of this study was to examine the effect of physical training on ventricular remodeling, serum cardiac markers, and exercise performance in women with human epidermal growth receptor 2 (HER2+) breast cancer (BC) undergoing trastuzumab therapy. This was a prospective, randomized, clinical controlled trial. Forty-six BC women were randomized into either an intervention group (IG) or a control group (CG). An exercise program (IG) was performed after 3-6 months of trastuzumab therapy at 5 d/week (to 80% maximum heart rate (HRmax)) for 9 weeks. We then evaluated their cardiac function using echocardiography, a 6-Minute Walk Test (6MWT), and plasma parameters (C-reactive protein (CRP), myoglobin (MYO), interleukin-6 (IL-6), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and creatine kinase (CK)). After the physical training program, we did not observe any significant changes in the left ventricular (LV) ejection fraction (LVEF) and 6MWT ( p  > 0.05) in the IG compared to the CG (decrease  p  < 0.05). The differences in the blood parameters were not significant ( p  < 0.05). To conclude, moderate-intensity exercise training prevented a decrease in the LVEF and physical capacity during trastuzumab therapy in HER2+ BC. Further research is needed to validate our results.",2020,The differences in the blood parameters were not significant ( p  < 0.05).,"['Forty-six BC women', 'Breast Cancer in Women', 'women with human epidermal growth receptor 2 (HER2+) breast cancer (BC) undergoing trastuzumab therapy']","['trastuzumab therapy', 'supervised and moderate-intensity exercise training', 'Regular Physical Training', 'physical training', 'Physical exercise', 'intervention group (IG) or a control group (CG', 'moderate-intensity exercise training']","['blood parameters', '6-Minute Walk Test (6MWT), and plasma parameters (C-reactive protein (CRP), myoglobin (MYO), interleukin-6 (IL-6), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and creatine kinase (CK', 'heart failure', 'ventricular remodeling, serum cardiac markers, and exercise performance', 'Cardiotoxicity', 'LVEF and physical capacity', 'left ventricular (LV) ejection fraction (LVEF) and 6MWT']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0027078', 'cui_str': 'Myoglobin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0600519', 'cui_str': 'Ventricular remodelling'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1271630', 'cui_str': 'Cardiac markers'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]",46.0,0.0258682,The differences in the blood parameters were not significant ( p  < 0.05).,"[{'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Hojan', 'Affiliation': 'Department of Rehabilitation, Greater Poland Cancer Centre, 61-866 Poznan, Poland.'}, {'ForeName': 'Danuta', 'Initials': 'D', 'LastName': 'Procyk', 'Affiliation': 'Central Labolatory, Greater Poland Cancer Centre, 61-866 Poznan, Poland.'}, {'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Horyńska-Kęstowicz', 'Affiliation': 'Department of Rehabilitation, Greater Poland Cancer Centre, 61-866 Poznan, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Leporowska', 'Affiliation': 'Central Labolatory, Greater Poland Cancer Centre, 61-866 Poznan, Poland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Litwiniuk', 'Affiliation': 'Department of Chemotherapy, Greater Poland Cancer Centre, 61-866 Poznan, Poland.'}]",Journal of clinical medicine,['10.3390/jcm9051379']
177,32394049,A Large-Scale Replication of the Effectiveness of the KiVa Antibullying Program: a Randomized Controlled Trial in the Netherlands.,"This study evaluates the effectiveness of the KiVa antibullying program in the Netherlands through a randomized controlled trial of students in grades 3-4 (Dutch grades 5-6). The sample involved 98 schools who volunteered to participate in the research, with 245 classes and 4383 students at the baseline (49% girls; M age = 8.7 years), who participated in five measurement waves, collected in three consecutive school years. After the baseline, two-thirds of the schools were assigned to the intervention condition (KiVa or KiVa+, the latter included an additional intervention component of network feedback to teachers) and one-third to the control condition (waiting list, care as usual) with a stratified randomization procedure. The effects of the intervention on self-reported victimization and bullying were tested using cross-classified ordered multinomial models and binomial logistic regression models. These longitudinal models showed that self-reported victimization and bullying reduced more strongly in KiVa-schools compared with control schools, with stronger effects after two school years than after one school year of implementation. The results showed that for students in control schools, the odds of being a victim were 1.29-1.63 higher, and the odds of being a bully were 1.19-1.66 higher than for KiVa students. No significant differences between KiVa and KiVa+ emerged. Overall, the findings provide evidence of the effectiveness of the KiVa program in the Netherlands.",2020,"These longitudinal models showed that self-reported victimization and bullying reduced more strongly in KiVa-schools compared with control schools, with stronger effects after two school years than after one school year of implementation.","['students in grades 3-4 (Dutch grades 5-6', '98 schools who volunteered to participate in the research, with 245 classes and 4383 students at the baseline (49% girls; M age\u2009=\u20098.7\xa0years), who participated in five measurement waves, collected in three consecutive school years']","['KiVa Antibullying Program', 'intervention condition (KiVa or KiVa+, the latter included an additional intervention component of network feedback to teachers) and one-third to the control condition (waiting list, care as usual) with a stratified randomization procedure', 'KiVa antibullying program']",['odds of being a victim'],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C1705232', 'cui_str': 'Common terminology criteria for adverse events grade 5'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517880', 'cui_str': '8.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C1278569', 'cui_str': 'WAS A'}]",98.0,0.0250472,"These longitudinal models showed that self-reported victimization and bullying reduced more strongly in KiVa-schools compared with control schools, with stronger effects after two school years than after one school year of implementation.","[{'ForeName': 'Gijs', 'Initials': 'G', 'LastName': 'Huitsing', 'Affiliation': 'Department of Sociology, University of Groningen, and Interuniversity Center for Social Science Theory and Methodology (ICS), Groningen, The Netherlands. g.e.huitsing@rug.nl.'}, {'ForeName': 'Gerine M A', 'Initials': 'GMA', 'LastName': 'Lodder', 'Affiliation': 'Department of Sociology, University of Groningen, and Interuniversity Center for Social Science Theory and Methodology (ICS), Groningen, The Netherlands.'}, {'ForeName': 'Wiliam J', 'Initials': 'WJ', 'LastName': 'Browne', 'Affiliation': 'School of Education, University of Bristol, Bristol, UK.'}, {'ForeName': 'Beau', 'Initials': 'B', 'LastName': 'Oldenburg', 'Affiliation': 'Department of Sociology, University of Groningen, and Interuniversity Center for Social Science Theory and Methodology (ICS), Groningen, The Netherlands.'}, {'ForeName': 'Rozemarijn', 'Initials': 'R', 'LastName': 'Van der Ploeg', 'Affiliation': 'Department of Pedagogy and Educational Science, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Veenstra', 'Affiliation': 'Department of Sociology, University of Groningen, and Interuniversity Center for Social Science Theory and Methodology (ICS), Groningen, The Netherlands.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01116-4']
178,32397192,Effects of a Multicomponent Exercise Program in Physical Function and Muscle Mass in Sarcopenic/Pre-Sarcopenic Adults.,"This study aimed to assess the effects of a multicomponent exercise program on physical function and muscle mass in older adults with sarcopenia or pre-sarcopenia. Moreover, we aim to standardize the exercise program for easy incorporation in the daily life of community-dwelling older adults as a secondary outcome. A single-blind randomized controlled trial was conducted with individuals (≥60 years) who had sarcopenia or pre-sarcopenia ( n  = 72). Participants were randomly assigned to the exercise and control groups. The exercise program consisted of 12 weekly 60-minute sessions that included resistance, balance, flexibility, and aerobic training. Outcome measures were physical function and muscle mass. Assessments were conducted before and immediately after the intervention. Among the 72 participants (mean age: 75.0 ± 6.9 years; 70.8% women), 67 (93.1%) completed the trial. Group-by-time interactions on the chair stand ( p  = 0.02) and timed ""up and go"" ( p  = 0.01) tests increased significantly in the exercise group. Although the exercise group showed a tendency to prevent loss of muscle mass, no significant interaction effects were observed for cross-sectional muscle area and muscle volume. The 12-week exercise program improved physical function in the intervention group. Although it is unclear whether the program is effective in increasing muscle mass, a multicomponent exercise program would be an effective treatment for physical function among older adults with sarcopenia.",2020,"Group-by-time interactions on the chair stand ( p  = 0.02) and timed ""up and go"" ( p  = 0.01) tests increased significantly in the exercise group.","['72 participants (mean age: 75.0 ± 6.9 years; 70.8% women), 67 (93.1%) completed the trial', 'community-dwelling older adults', 'older adults with sarcopenia', 'Sarcopenic/Pre-Sarcopenic Adults', 'individuals (≥60 years) who had sarcopenia or pre-sarcopenia ( n  = 72', 'older adults with sarcopenia or pre-sarcopenia']","['Multicomponent Exercise Program', 'multicomponent exercise program', 'exercise program']","['physical function', 'physical function and muscle mass', 'Physical Function and Muscle Mass', 'loss of muscle mass']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517826', 'cui_str': '6.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}]",72.0,0.0366604,"Group-by-time interactions on the chair stand ( p  = 0.02) and timed ""up and go"" ( p  = 0.01) tests increased significantly in the exercise group.","[{'ForeName': 'Hyuma', 'Initials': 'H', 'LastName': 'Makizako', 'Affiliation': 'Department of Physical Therapy, School of Health Sciences, Faculty of Medicine, Kagoshima University, Kagoshima 890-8544, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Nakai', 'Affiliation': 'Department of Physical Therapy, School of Health Sciences, Faculty of Medicine, Kagoshima University, Kagoshima 890-8544, Japan.'}, {'ForeName': 'Kazutoshi', 'Initials': 'K', 'LastName': 'Tomioka', 'Affiliation': 'Graduate School of Health Sciences, Kagoshima University, Kagoshima 890-8544, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Taniguchi', 'Affiliation': 'Graduate School of Health Sciences, Kagoshima University, Kagoshima 890-8544, Japan.'}, {'ForeName': 'Nana', 'Initials': 'N', 'LastName': 'Sato', 'Affiliation': 'Graduate School of Health Sciences, Kagoshima University, Kagoshima 890-8544, Japan.'}, {'ForeName': 'Ayumi', 'Initials': 'A', 'LastName': 'Wada', 'Affiliation': 'Graduate School of Health Sciences, Kagoshima University, Kagoshima 890-8544, Japan.'}, {'ForeName': 'Ryoji', 'Initials': 'R', 'LastName': 'Kiyama', 'Affiliation': 'Department of Physical Therapy, School of Health Sciences, Faculty of Medicine, Kagoshima University, Kagoshima 890-8544, Japan.'}, {'ForeName': 'Kota', 'Initials': 'K', 'LastName': 'Tsutsumimoto', 'Affiliation': 'Center for Gerontology and Social Science, National Center for Geriatrics and Gerontology, Obu 474-5811, Japan.'}, {'ForeName': 'Mitsuru', 'Initials': 'M', 'LastName': 'Ohishi', 'Affiliation': 'Department of Cardiovascular Medicine and Hypertension, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima 890-8520, Japan.'}, {'ForeName': 'Yuto', 'Initials': 'Y', 'LastName': 'Kiuchi', 'Affiliation': 'Graduate School of Health Sciences, Kagoshima University, Kagoshima 890-8544, Japan.'}, {'ForeName': 'Takuro', 'Initials': 'T', 'LastName': 'Kubozono', 'Affiliation': 'Department of Cardiovascular Medicine and Hypertension, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima 890-8520, Japan.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Takenaka', 'Affiliation': 'Tarumizu Municipal Medical Center Tarumizu Chuo Hospital, Kagoshima 891-2124, Japan.'}]",Journal of clinical medicine,['10.3390/jcm9051386']
179,32335058,Static and Dynamic Factors Associated With Extended Depth of Focus in Monofocal Intraocular Lenses.,"PURPOSE


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


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


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


Corneal profile and type of IOL implanted were the most important factors influencing near vision functionality with aspheric monofocal IOLs. Higher positive SA in the aberration-free group potentially led to better DCNVA than the negative-SA group in normal eyes. Hyperprolate corneas had better DOF curves and DCNVA than normal corneas.",2020,The aberration-free IOL group showed significantly better DCNVA and higher total SA than the negative-SA group.,"['eyes implanted with aspheric monofocal intraocular lenses (IOLs', 'Ninety-one normal eyes', '111 eyes of 74 patients that underwent']","['aberration-free IOLs', 'negative-spherical aberration (SA) (ZCB00) IOLs', 'phacoemulsification with monofocal IOL implantation', 'aberration-free (MX60E']","['DOF curves and DCNVA', 'Corneal higher-order aberrations (SA, coma, trefoil and corneal asphericity for 6-mm pupil', 'DCNVA, higher negative SA, coma and Q value (p<.05), and smaller pupil size', 'Ray tracing metrics [visual strehl optical transfer function (VSOTF), effective range of focus (EROF), sphere shift (SS), EROF-SS], pupil size measurements at far and near, ocular and corneal SA', 'Distance-corrected near visual acuity (DCNVA) and subjective defocus curves']","[{'cui': 'C0581278', 'cui_str': 'Ophthalmological implant'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0950061', 'cui_str': 'Trefoil'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0026205', 'cui_str': 'Persistent miosis'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0086894', 'cui_str': 'Rajiformes'}, {'cui': 'C0442822', 'cui_str': 'Trace'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0517965', 'cui_str': 'Size of pupil'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429541', 'cui_str': 'Near visual acuity'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",111.0,0.0231069,The aberration-free IOL group showed significantly better DCNVA and higher total SA than the negative-SA group.,"[{'ForeName': 'Karolinne Maia', 'Initials': 'KM', 'LastName': 'Rocha', 'Affiliation': 'Storm Eye Institute - Medical University of South Carolina, Charleston, South Carolina, USA. Electronic address: rochak@musc.edu.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Gouvea', 'Affiliation': 'Storm Eye Institute - Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'George Oral', 'Initials': 'GO', 'LastName': 'Waring', 'Affiliation': 'Waring Vision Institute, Mt. Pleasant, South Carolina, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Haddad', 'Affiliation': 'Storm Eye Institute - Medical University of South Carolina, Charleston, South Carolina, USA; Federal University of Sao Paulo - UNIFESP, São Paulo, Brazil.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.04.014']
180,32397344,A Randomized Comparison of Plasma Levobupivacaine Concentrations Following Thoracic Epidural Analgesia and Subpleural Paravertebral Analgesia in Open Thoracic Surgery.,"BACKGROUND


The aim of this study was to compare plasma levobupivacaine concentrations in thoracic epidural and subpleural paravertebral analgesia.
METHODS


Forty-four patients indicated for open lung resection had an epidural catheter inserted preoperatively or a subpleural catheter surgically. A bolus of 0.25% levobupivacaine at a dosage of 0.5 mg × kg -1  was given after the thoracotomy closure. Plasma levobupivacaine level at 30 min was the primary outcome. Pharmacokinetic modeling was performed subsequently. Secondary outcomes included the quality of analgesia, complications, and patients'mobility.
RESULTS


Plasma concentrations were similar 30 min after application-0.389 mg × L -1  in the epidural and 0.318 mg × L -1  in the subpleural group ( p  = 0.33) and lower in the subpleural group at 120 min ( p  = 0.03). The areas under the curve but not maximum concentrations were lower in the subpleural group. The time to reach maximum plasma level was similar in both groups-27.6 vs. 24.2 min. No clinical symptoms of local anesthetic toxicity were recorded.
CONCLUSIONS


Levobupivacaine systemic concentrations were low in both groups without the symptoms of toxicity. This dosage should be safe for postoperative analgesia after thoracotomy.",2020,The time to reach maximum plasma level was similar in both groups-27.6 vs. 24.2 min.,"['Forty-four patients indicated for', 'Open Thoracic Surgery']","['open lung resection', 'Plasma Levobupivacaine Concentrations', 'Thoracic Epidural Analgesia and Subpleural Paravertebral Analgesia', 'epidural catheter inserted preoperatively or a subpleural catheter surgically', 'levobupivacaine']","['local anesthetic toxicity', 'Plasma concentrations', 'time to reach maximum plasma level', 'plasma levobupivacaine concentrations', 'Plasma levobupivacaine level', ""quality of analgesia, complications, and patients'mobility""]","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0396565', 'cui_str': 'Lung excision'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0179751', 'cui_str': 'Epidural catheter'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0473977', 'cui_str': 'Local anesthetic toxicity'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0783513,The time to reach maximum plasma level was similar in both groups-27.6 vs. 24.2 min.,"[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Matek', 'Affiliation': '1st Department of Surgery-Department of Abdominal, Thoracic Surgery and Traumatology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague, 128 00 Prague, Czech Republic.'}, {'ForeName': 'Stanislav', 'Initials': 'S', 'LastName': 'Cernohorsky', 'Affiliation': '1st Department of Surgery-Department of Abdominal, Thoracic Surgery and Traumatology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague, 128 00 Prague, Czech Republic.'}, {'ForeName': 'Stanislav', 'Initials': 'S', 'LastName': 'Trca', 'Affiliation': '1st Department of Surgery-Department of Abdominal, Thoracic Surgery and Traumatology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague, 128 00 Prague, Czech Republic.'}, {'ForeName': 'Zdenek', 'Initials': 'Z', 'LastName': 'Krska', 'Affiliation': '1st Department of Surgery-Department of Abdominal, Thoracic Surgery and Traumatology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague, 128 00 Prague, Czech Republic.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hoskovec', 'Affiliation': '1st Department of Surgery-Department of Abdominal, Thoracic Surgery and Traumatology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague, 128 00 Prague, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Bruthans', 'Affiliation': 'Department of Anaesthesia and Intensive Care, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague, 128 00 Prague, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sima', 'Affiliation': 'Institute of Pharmacology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague, 128 00 Prague, Czech Republic.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Michalek', 'Affiliation': 'Department of Anaesthesia and Intensive Care, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague, 128 00 Prague, Czech Republic.'}]",Journal of clinical medicine,['10.3390/jcm9051395']
181,32397586,Basic Laparoscopic Skills Training Is Equally Effective Using 2D Compared to 3D Visualization: A Randomized Controlled Trial.,"Reduced depth perception due to two-dimensional (2D) visualization of a three-dimensional (3D) space represents a main challenge in acquiring basic laparoscopic skills (BLS); 3D visualization might increase training efficiency. This study aimed to assess whether BLS training on a standard box trainer using 2D is at least equally effective compared to 3D. Medical students were randomized to training of Fundamentals of Laparoscopic Surgery (FLS) tasks using either 2D or 3D for four weeks. Baseline and post-training tests were performed using the assigned visualization modality. Data of 31 participants were analyzed ( n  = 16 2D,  n  = 15 3D). Baseline test scores did not differ significantly between groups; only at the peg transfer task and total scores, the 3D group performed better than the 2D group. All scores improved significantly in both groups, with post training scores not differing significantly between groups. Non-inferiority of 2D compared to 3D was demonstrated for total score improvement and improvement in all individual FLS tasks except for suturing with extracorporeal knot tying. Post training test performance did not change significantly when changing to the unfamiliar modality. In conclusion, BLS training using standard 2D is at least equally effective as with 3D, without significant disadvantages when changing to the other modality.",2020,Non-inferiority of 2D compared to 3D was demonstrated for total score improvement and improvement in all individual FLS tasks except for suturing with extracorporeal knot tying.,"['31 participants were analyzed ( n  = 16 2D,  n  = 15 3D']","['Basic Laparoscopic Skills Training', 'BLS training', 'Laparoscopic Surgery (FLS) tasks']",['Reduced depth perception'],[],"[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0011586', 'cui_str': 'Stereoscopic vision'}]",31.0,0.035656,Non-inferiority of 2D compared to 3D was demonstrated for total score improvement and improvement in all individual FLS tasks except for suturing with extracorporeal knot tying.,"[{'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Montanari', 'Affiliation': 'Department of Gynecology and Obstetrics, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Schwameis', 'Affiliation': 'Department of Gynecology and Obstetrics, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Veit-Rubin', 'Affiliation': 'Department of Gynecology and Obstetrics, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Kuessel', 'Affiliation': 'Department of Gynecology and Obstetrics, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Heinrich', 'Initials': 'H', 'LastName': 'Husslein', 'Affiliation': 'Department of Gynecology and Obstetrics, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.'}]",Journal of clinical medicine,['10.3390/jcm9051408']
182,32397081,Acute Effects of Aerobic Exercise on Cognitive Attention and Memory Performance: An Investigation on Duration-Based Dose-Response Relations and the Impact of Increased Arousal Levels.,"Current evidence indicates that acute aerobic exercise might increase domain-specific cognitive performance. However, only a small number of studies deduced the impact on lower and higher cognitive functions systematically or analyzed dose-response relationships and the underlying mechanisms. This study aimed to expose the dose-response relationships by investigating the influence of exercise duration on subjective and objective arousal, cognitive attention and visual recognition memory tasks. Nineteen participants (eight female; 25.69 ± 3.11 years) were included in a randomized, three-armed intervention study in a cross-over design. The participants completed three different interventions consisting of either 15, 30 or 45 min of cycling at 60-70% VO 2 max. Arousal and cognitive measurements were taken before and immediately after (<2 min) exercise. All three interventions led to significant but comparable effects on self-perceived arousal, heart rate (HR) and rating of perceived exertion (RPE) ( p  < 0.05). Analysis of variance (ANOVA) indicated significant effects of exercise duration on visual recognition memory accuracy. Reaction times for higher and lower cognitive tasks did not change after exercise. Fifteen minutes of aerobic exercise was feasible to induce beneficial changes in self-perceived arousal. Processing speed of visual recognition memory and attention remained unaltered. Exercise exceeding fifteen minutes seemed to negatively impact visual recognition memory accuracy.",2020,"All three interventions led to significant but comparable effects on self-perceived arousal, heart rate (HR) and rating of perceived exertion (RPE) ( p  < 0.05).",['Nineteen participants (eight female; 25.69 ± 3.11 years'],"['Aerobic Exercise', 'aerobic exercise']","['Cognitive Attention and Memory Performance', 'self-perceived arousal, heart rate (HR) and rating of perceived exertion (RPE', 'Arousal and cognitive measurements', 'subjective and objective arousal, cognitive attention and visual recognition memory tasks', 'visual recognition memory accuracy', 'domain-specific cognitive performance', 'Reaction times for higher and lower cognitive tasks']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1285654', 'cui_str': 'Memory performance'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",19.0,0.17255,"All three interventions led to significant but comparable effects on self-perceived arousal, heart rate (HR) and rating of perceived exertion (RPE) ( p  < 0.05).","[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Hacker', 'Affiliation': 'Department of Sports Medicine, Institute of Psychology and Sports Sciences, Goethe University, 60487 Frankfurt, Germany.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Banzer', 'Affiliation': 'Department of Preventive and Sports Medicine, Institute of Occupational, Social and Environmental Medicine, Goethe University, 60590 Frankfurt, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Vogt', 'Affiliation': 'Department of Sports Medicine, Institute of Psychology and Sports Sciences, Goethe University, 60487 Frankfurt, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Engeroff', 'Affiliation': 'Department of Preventive and Sports Medicine, Institute of Occupational, Social and Environmental Medicine, Goethe University, 60590 Frankfurt, Germany.'}]",Journal of clinical medicine,['10.3390/jcm9051380']
183,32398113,Propranolol for familial cerebral cavernous malformation (Treat_CCM): study protocol for a randomized controlled pilot trial.,"BACKGROUND


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


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


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


ClinicalTrails.gov, NCT03589014. Retrospectively registered on 17 July 2018.",2020,The primary outcome is intracranial haemorrhage or focal neurological deficit attributable to CCMs.,"['six Italian clinical centres with central reading of brain magnetic resonance imaging (MRI) and adverse events', 'familial cerebral cavernous malformation (Treat_CCM', 'Retrospectively registered on 17 July 2018', 'Patients with symptomatic FCCMs']","['Propranolol', 'propranolol (40-80\u2009mg twice daily) in addition to standard care or to standard care alone (i.e. anti-epileptic drugs or headache treatments', 'propranolol', 'Neurosurgical excision, and perhaps stereotactic radiosurgery']","['MRI changes over time (i.e. de novo CCM lesions, CCM size and signal characteristics, iron deposition, and vascular leakage as assessed by quantitative susceptibility mapping and dynamic contrast enhanced permeability), disability, health-related quality of life, depression severity, and anxiety (SF-36, BDI-II, State-Trait Anxiety Inventory', 'safety and efficacy', 'intracranial haemorrhage or focal neurological deficit attributable to CCMs']","[{'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2931263', 'cui_str': 'Hereditary cavernous hemangioma of brain'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]","[{'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0085203', 'cui_str': 'Radiosurgery'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0065772', 'cui_str': 'MCC protocol'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0333596', 'cui_str': 'Deposition of iron'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C2919945', 'cui_str': 'Cavernous hemangioma of brain'}]",,0.228911,The primary outcome is intracranial haemorrhage or focal neurological deficit attributable to CCMs.,"[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Lanfranconi', 'Affiliation': 'Department of Neurology, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Padiglione Monteggia-piano 3, Via Francesco Sforza 35, 20122, Milan, Italy. silvia.lanfranconi@policlinico.mi.it.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Scola', 'Affiliation': 'Department of Neuroradiology, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Via Francesco Sforza 35, 20122, Milan, Italy.'}, {'ForeName': 'Giulio Andrea', 'Initials': 'GA', 'LastName': 'Bertani', 'Affiliation': 'Department of Neurosurgery, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Via Francesco Sforza 35, 20122, Milan, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Zarino', 'Affiliation': 'Department of Neurosurgery, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Via Francesco Sforza 35, 20122, Milan, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Pallini', 'Affiliation': 'Department of Neurosurgery, Università Cattolica del Sacro Cuore, Largo Francesco Vito 1, 00168, Rome, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': ""d'Alessandris"", 'Affiliation': 'Department of Neurosurgery, Università Cattolica del Sacro Cuore, Largo Francesco Vito 1, 00168, Rome, Italy.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Mazzon', 'Affiliation': 'IRCCS Centro Neurolesi ""Bonino Pulejo"", Contrada Casazza, 98124, Messina, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Marino', 'Affiliation': 'IRCCS Centro Neurolesi ""Bonino Pulejo"", Contrada Casazza, 98124, Messina, Italy.'}, {'ForeName': 'Maria Rita', 'Initials': 'MR', 'LastName': 'Carriero', 'Affiliation': 'Cerebrovascular Disease Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, Via Giovanni Celoria 11, 20133, Milan, Italy.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Scelzo', 'Affiliation': 'Cerebrovascular Disease Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, Via Giovanni Celoria 11, 20133, Milan, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Faragò', 'Affiliation': 'Department of Neuroradiology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Via Giovanni Celoria 11, 20133, Milan, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Castori', 'Affiliation': 'Division of Medical Genetics, Fondazione IRCCS Casa Sollievo della Sofferenza, Viale Cappuccini 2, 71013, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Carmela', 'Initials': 'C', 'LastName': 'Fusco', 'Affiliation': 'Division of Medical Genetics, Fondazione IRCCS Casa Sollievo della Sofferenza, Viale Cappuccini 2, 71013, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Petracca', 'Affiliation': 'Division of Medical Genetics, Fondazione IRCCS Casa Sollievo della Sofferenza, Viale Cappuccini 2, 71013, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': ""d'Agruma"", 'Affiliation': 'Division of Medical Genetics, Fondazione IRCCS Casa Sollievo della Sofferenza, Viale Cappuccini 2, 71013, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Tassi', 'Affiliation': '""Claudio Munari"" Epilepsy Surgery Centre, ASST Grande Ospedale Metropolitano Niguarda, Piazza dell\'Ospedale Maggiore 3, 20162, Milan, Italy.'}, {'ForeName': 'Piergiorgio', 'Initials': 'P', 'LastName': ""d'Orio"", 'Affiliation': '""Claudio Munari"" Epilepsy Surgery Centre, ASST Grande Ospedale Metropolitano Niguarda, Piazza dell\'Ospedale Maggiore 3, 20162, Milan, Italy.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Lampugnani', 'Affiliation': 'Laboratory of Vascular Biology, IFOM, Firc Institute for Molecular Oncology, Via Adamello 16, 20139, Milan, Italy.'}, {'ForeName': 'Enrico Bjorn', 'Initials': 'EB', 'LastName': 'Nicolis', 'Affiliation': 'Laboratory of Cardiovascular Clinical Pharmacology, Mario Negri Institute for Pharmacological Research-IRCCS, Via Mario Negri, 2, 20156, Milan, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Vasamì', 'Affiliation': 'Laboratory of Cardiovascular Clinical Pharmacology, Mario Negri Institute for Pharmacological Research-IRCCS, Via Mario Negri, 2, 20156, Milan, Italy.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Novelli', 'Affiliation': 'Laboratory of Cardiovascular Clinical Pharmacology, Mario Negri Institute for Pharmacological Research-IRCCS, Via Mario Negri, 2, 20156, Milan, Italy.'}, {'ForeName': 'Valter', 'Initials': 'V', 'LastName': 'Torri', 'Affiliation': 'Laboratory of Research Methodology, Mario Negri Institute for Pharmacological Research-IRCCS, Via Mario Negri, 2, 20156, Milan, Italy.'}, {'ForeName': 'Jennifer Marie Theresia Anna', 'Initials': 'JMTA', 'LastName': 'Meessen', 'Affiliation': 'Laboratory of Cardiovascular Clinical Pharmacology, Mario Negri Institute for Pharmacological Research-IRCCS, Via Mario Negri, 2, 20156, Milan, Italy.'}, {'ForeName': 'Rustam', 'Initials': 'R', 'LastName': 'Al-Shahi Salman', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Little France Crescent 49, Edinburgh, EH16 4SB, UK.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Dejana', 'Affiliation': 'Laboratory of Vascular Biology, IFOM, Firc Institute for Molecular Oncology, Via Adamello 16, 20139, Milan, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Latini', 'Affiliation': 'Laboratory of Cardiovascular Clinical Pharmacology, Mario Negri Institute for Pharmacological Research-IRCCS, Via Mario Negri, 2, 20156, Milan, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-4202-x']
184,32333641,"Immunogenicity and safety of a proposed pegfilgrastim biosimilar MSB11455 versus the reference pegfilgrastim Neulasta ®  in healthy subjects: A randomized, double-blind trial.","MSB11455 is a proposed biosimilar to the currently licensed reference pegfilgrastim (Neulasta ®  ). This study was designed primarily to compare the immunogenicity of MSB11455 and Neulasta ®  . As secondary objectives, the safety and tolerability of MSB11455 and Neulasta ®  were also compared. Healthy adult subjects were randomized to either MSB11455 or Neulasta ®  , stratified by antipolyethylene glycol (PEG) antibody status at screening and study site. Subjects received a single subcutaneous dose of MSB11455 or Neulasta ®  (both 6 mg/0.6 mL) on day 1 of each of two study periods (same product in both periods), separated by a washout of 28-35 days. Immunogenicity samples were taken predose and up to day 84 post-first dose. Noninferiority was confirmed if the upper limit of the exact one-sided adjusted 95% confidence interval (CI) for the difference in antidrug antibody (ADA)-positive rates was < 10%. Safety was assessed throughout the study. Overall, 336 subjects were randomized and treated (N = 168 in each group). Noninferiority of MSB11455 over Neulasta ®  was demonstrated for immunogenicity; the difference in confirmed treatment-induced ADA-positive rate between MSB11455 and Neulasta ®  was -0.6% (upper limit of the exact one-sided adjusted 95% CI: 6.25%). ADAs were mostly directed against the PEG moiety of pegfilgrastim. No filgrastim-specific neutralizing antibodies were detected in either treatment group. Safety and tolerability were as expected for pegfilgrastim, and comparable between treatments. This study supports and strengthens the available evidence for the biosimilarity of MSB11455 to Neulasta ®  .",2020,Noninferiority was confirmed if the upper limit of the exact one-sided adjusted 95% confidence interval (CI) for the difference in antidrug antibody (ADA)-positive rates was < 10%.,"['Healthy adult subjects', 'healthy subjects', '336 subjects were randomized and treated (N\xa0=\xa0168 in each group']","['MSB11455 or Neulasta ®', 'pegfilgrastim biosimilar MSB11455', 'MSB11455', 'MSB11455 or Neulasta ®  , stratified by antipolyethylene glycol (PEG) antibody status at screening and study site']","['Safety', 'Safety and tolerability', 'Immunogenicity and safety', 'safety and tolerability of MSB11455 and Neulasta ®', 'antidrug antibody (ADA)-positive rates']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1171279', 'cui_str': 'Neulasta'}, {'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0017951', 'cui_str': 'Glycol'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1171279', 'cui_str': 'Neulasta'}, {'cui': 'C0741132', 'cui_str': 'Antibody test positive'}]",336.0,0.130076,Noninferiority was confirmed if the upper limit of the exact one-sided adjusted 95% confidence interval (CI) for the difference in antidrug antibody (ADA)-positive rates was < 10%.,"[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Wynne', 'Affiliation': 'Christchurch Clinical Studies Trust Ltd, Christchurch, New Zealand.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schwabe', 'Affiliation': 'Auckland Clinical Studies Ltd, Auckland, New Zealand.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Vincent', 'Affiliation': 'Fresenius Kabi SwissBioSim GmbH, Eysins, Switzerland.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Schueler', 'Affiliation': 'Biostatistics, Merck Healthcare, Darmstadt, Germany.'}, {'ForeName': 'Janka', 'Initials': 'J', 'LastName': 'Ryding', 'Affiliation': 'SVAR Life Science - Wieslab AB, Lund, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Ullmann', 'Affiliation': 'Fresenius Kabi SwissBioSim GmbH, Eysins, Switzerland.'}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Ghori', 'Affiliation': 'Fresenius Kabi SwissBioSim GmbH, Eysins, Switzerland.'}, {'ForeName': 'Radmila', 'Initials': 'R', 'LastName': 'Kanceva', 'Affiliation': 'Fresenius Kabi SwissBioSim GmbH, Eysins, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stahl', 'Affiliation': 'Fresenius Kabi SwissBioSim GmbH, Eysins, Switzerland.'}]",Pharmacology research & perspectives,['10.1002/prp2.578']
185,32335287,Isradipine enhancement of virtual reality cue exposure for smoking cessation: Rationale and study protocol for a double-blind randomized controlled trial.,"Cigarette smoking remains a leading cause of preventable death in the United States, contributing to over 480,000 deaths each year. Although significant strides have been made in the development of effective smoking cessation treatments, most established interventions are associated with high relapse rates. One avenue for increasing the effectiveness of smoking cessation interventions is to design focused, efficient, and rigorous experiments testing engagement of well-defined mechanistic targets. Toward this aim, the current protocol will apply a pharmacologic augmentation strategy informed by basic research in animal models of addiction. Our goal is to evaluate the enhancing effect of isradipine, an FDA-approved calcium channel blocker, on the extinction of craving-a key mechanism of drug relapse after periods of abstinence. To activate craving robustly in human participants, we will use multimodal smoking cues including novel 360° video environments developed for this project and delivered through consumer virtual reality headsets. Adult smokers will take either isradipine or placebo and complete the cue exposure protocol in a double-blind randomized control trial. In order to test the hypothesis that isradipine will enhance retention of craving extinction, participants will repeat cue exposure 24 h later without the administration of isradipine or placebo. The study will be implemented in a primary care setting where adult smokers receive healthcare, and smoking behavior will be tracked throughout the trial with ecological momentary assessment.",2020,"In order to test the hypothesis that isradipine will enhance retention of craving extinction, participants will repeat cue exposure 24 h later without the administration of isradipine or placebo.","['human participants', 'Adult smokers', 'smoking cessation']","['isradipine', 'Isradipine', 'isradipine or placebo']",[],"[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]","[{'cui': 'C0071304', 'cui_str': 'Isradipine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.135599,"In order to test the hypothesis that isradipine will enhance retention of craving extinction, participants will repeat cue exposure 24 h later without the administration of isradipine or placebo.","[{'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Papini', 'Affiliation': 'Department of Psychology, The University of Texas at Austin, Austin, TX, United States.; Institute for Mental Health Research, The University of Texas at Austin, Austin, TX, USA. Electronic address: spapini@utexas.edu.'}, {'ForeName': 'Cara C', 'Initials': 'CC', 'LastName': 'Young', 'Affiliation': 'School of Nursing, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Catherine S', 'Initials': 'CS', 'LastName': 'Gebhardt', 'Affiliation': 'Department of Psychology, The University of Texas at Austin, Austin, TX, United States.; Institute for Mental Health Research, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Perrone', 'Affiliation': 'Department of Psychology, The University of Texas at Austin, Austin, TX, United States.; Institute for Mental Health Research, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Morikawa', 'Affiliation': 'Department of Neuroscience, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Otto', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, MA, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Roache', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Jasper A J', 'Initials': 'JAJ', 'LastName': 'Smits', 'Affiliation': 'Department of Psychology, The University of Texas at Austin, Austin, TX, United States.; Institute for Mental Health Research, The University of Texas at Austin, Austin, TX, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106013']
186,32335288,The 'Take a Break' game: Randomized trial protocol for a technology-assisted brief abstinence experience designed to engage lower-motivated smokers.,"BACKGROUND


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


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


Take a Break is an innovative approach to engage those not prepared for a quit attempt. Take a Break provides motivation phase smokers with tools and a brief experience to prepare them for a quit attempt, filling a gap in tobacco cessation support and current research.",2020,"Primary outcomes include number of days abstinent during the challenge, change in patient-reported self-efficacy after the challenge, time to first quit attempt following the challenge, and 7-day point prevalent smoking cessation at six months.
","['engage lower-motivated smokers', 'smokers not ready to quit']","['Motivational Messages, 2) text message Challenge Quizzes, 3) Goal-setting with tobacco treatment specialist, 4) Coping Mini-Games apps, and 5) Recognition and Rewards for participation during a 3-week challenge', 'Nicotine Replacement Therapy (NRT) sampling and daily smoking assessment text messages']","['number of days abstinent during the challenge, change in patient-reported self-efficacy after the challenge, time to first quit attempt following the challenge, and 7-day point prevalent smoking cessation']","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3853073', 'cui_str': 'Smoking assessment'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]",,0.0313065,"Primary outcomes include number of days abstinent during the challenge, change in patient-reported self-efficacy after the challenge, time to first quit attempt following the challenge, and 7-day point prevalent smoking cessation at six months.
","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Amante', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America. Electronic address: daniel.amante@umassmed.edu.'}, {'ForeName': 'Amanda C', 'Initials': 'AC', 'LastName': 'Blok', 'Affiliation': 'VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, United States Department of Veterans Affairs, Ann Arbor, MI, United States of America; Systems, Populations and Leadership Department, School of Nursing, University of Michigan, Ann Arbor, MI, United States of America.'}, {'ForeName': 'Catherine S', 'Initials': 'CS', 'LastName': 'Nagawa', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America.'}, {'ForeName': 'Jessica G', 'Initials': 'JG', 'LastName': 'Wijesundara', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America.'}, {'ForeName': 'Jeroan J', 'Initials': 'JJ', 'LastName': 'Allison', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America.'}, {'ForeName': 'Sharina D', 'Initials': 'SD', 'LastName': 'Person', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Morley', 'Affiliation': 'Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, United States of America; Feinstein Institute for Medical Research, Manhasset, NY, United States of America.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Conigliaro', 'Affiliation': 'Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, United States of America; Feinstein Institute for Medical Research, Manhasset, NY, United States of America.'}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Mattocks', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America; VA Central Western Massachusetts Healthcare System, Leeds, MA, United States of America.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Garber', 'Affiliation': 'Reliant Medical Group, Worcester, MA, United States of America.'}, {'ForeName': 'Thomas K', 'Initials': 'TK', 'LastName': 'Houston', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America; Department of Internal Medicine, Wake Forest University School of Medicine, Winston-Salem, NC, United States of America.'}, {'ForeName': 'Rajani S', 'Initials': 'RS', 'LastName': 'Sadasivam', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106002']
187,32291387,Comparison of abdominal compression devices in persons with abdominal paralysis due to spinal cord injury.,"STUDY DESIGN


Single subject design with five subjects.
OBJECTIVES


The objetive of this study is to compare the effectiveness and usability of alternative commercial abdominal compression garments with participants' usual medical binders.
SETTING


Private residences in Pierce and King Counties, WA, USA.
METHODS


Participants wore each garment for 5 days followed by a 2-day washout in personal binder. Week 1: Personal binder. Weeks 2 and 3: Randomly ordered test garments (tank, bodysuit). Physiologic measurements: blood pressure (SBP, DBP), blood oxygen saturation (SaO 2 ), forced expiratory volume in one second (FEV 1 ), and heart rate (HR). Participants completed logs twice daily for 5 days per garment regarding ease of use, comfort, respiration, and appearance. We certify that all applicable institutional and governmental regulations concerning the ethical use of human volunteers were followed during the course of this research.
RESULTS


The use of a personal binder results in significant increases in SBP and FEV 1 . Personal binders support FEV 1  significantly better than test garments. There is no difference in SBP between test garments and personal binders. There are no significant differences between DBP, SaO 2 , or HR between participants' personal binders and no binder. Participants reported that neither tank nor bodysuit felt adequately supportive or easy to use.
CONCLUSIONS


Abdominal compression improves respiratory function and supports SBP in individuals with chronic SCI. Further research is needed to guide the development of an easy-to-use and physiologically supportive abdominal compression garment.",2019,"There are no significant differences between DBP, SaO 2 , or HR between participants' personal binders and no binder.","['Private residences in Pierce and King Counties, WA, USA.\nMETHODS', 'persons with abdominal paralysis due to spinal cord injury', 'human volunteers', 'individuals with chronic SCI', 'Single subject design with five subjects']","['alternative commercial abdominal compression garments', 'abdominal compression devices', ' Randomly ordered test garments (tank, bodysuit', 'Abdominal compression']","['DBP, SaO 2 , or HR', 'SBP', 'respiratory function', 'Physiologic measurements: blood pressure (SBP, DBP), blood oxygen saturation (SaO 2 ), forced expiratory volume in one second (FEV 1 ), and heart rate (HR', 'SBP and FEV 1 ']","[{'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0848128', 'cui_str': 'Piercing, Body'}, {'cui': 'C0454792', 'cui_str': 'Offaly'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0237766', 'cui_str': 'Hysterical paralysis'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C2985539', 'cui_str': 'Compression garment'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009072', 'cui_str': 'Garments'}, {'cui': 'C0336821', 'cui_str': 'Tank'}]","[{'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C1862322', 'cui_str': 'Southeast Asian ovalocytosis'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0199213', 'cui_str': 'Physiologic measurement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}]",5.0,0.0276293,"There are no significant differences between DBP, SaO 2 , or HR between participants' personal binders and no binder.","[{'ForeName': 'Michaela de', 'Initials': 'M', 'LastName': 'Groot', 'Affiliation': 'University of Puget Sound, Tacoma, WA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Swartz', 'Affiliation': 'University of Puget Sound, 1500 N Warner St. CMB 1030, 98416, Tacoma, WA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hastings', 'Affiliation': 'University of Puget Sound, 1500 N Warner St. CMB 1030, 98416, Tacoma, WA, USA. jhastings@pugetsound.edu.'}]",Spinal cord series and cases,['10.1038/s41394-019-0176-x']
188,32299024,"A double-blind, randomized controlled trial of duloxetine for pain in Parkinson's disease.","BACKGROUND


Duloxetine proved effective for treating pain in people with Parkinson's disease in a single-arm, open-label study.
OBJECTIVE


To evaluate the efficacy of duloxetine in a double-blind, randomized, placebo-controlled trial.
METHODS


We randomly assigned 46 patients with Parkinson's disease with pain to either the duloxetine 40 mg/day arm or the placebo arm. After 10 weeks, we tested the change from baseline in 24-hour average pain severity measured by a visual analogue scale.
RESULTS


We could not confirm the effect of duloxetine on pain. Exploratory analyses indicated that treatment with duloxetine was associated with improved scores on the Unified Parkinson's Disease Rating Scale Part III and 3 domains of the Parkinson's Disease Questionnaire - 39.
CONCLUSIONS


The study failed to provide evidence for the use of duloxetine for treating pain in people with Parkinson's disease.",2020,"Exploratory analyses indicated that treatment with duloxetine was associated with improved scores on the Unified Parkinson's Disease Rating Scale Part III and 3 domains of the Parkinson's Disease Questionnaire - 39.
","[""people with Parkinson's disease in a single-arm, open-label study"", ""pain in Parkinson's disease"", ""people with Parkinson's disease"", ""46 patients with Parkinson's disease with pain to either the""]","['duloxetine', 'placebo', 'Duloxetine', 'duloxetine 40\xa0mg/day arm or the placebo']","['24-hour average pain severity measured by a visual analogue scale', ""Unified Parkinson's Disease Rating Scale Part III and 3 domains of the Parkinson's Disease Questionnaire - 39"", 'pain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1576942', 'cui_str': 'duloxetine 40 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",46.0,0.692206,"Exploratory analyses indicated that treatment with duloxetine was associated with improved scores on the Unified Parkinson's Disease Rating Scale Part III and 3 domains of the Parkinson's Disease Questionnaire - 39.
","[{'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Iwaki', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan; Laboratory of Neurogenetics, National Institute on Aging, National Institute of Health, MD, USA; Data Tecnica International, MD, USA.'}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Ando', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Tada', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Nishikawa', 'Affiliation': 'Department of Neurology, National Center Hospital of Neurology and Psychiatry, Tokyo, Japan.'}, {'ForeName': 'Tomoaki', 'Initials': 'T', 'LastName': 'Tsujii', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Yamanishi', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Miyaue', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan; Department of Neurology, Saiseikai Matsuyama Hospital, Ehime, Japan.'}, {'ForeName': 'Hayato', 'Initials': 'H', 'LastName': 'Yabe', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan; Department of Neurology, Saiseikai Matsuyama Hospital, Ehime, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nagai', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nomoto', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan; Department of Neurology, Saiseikai Imabari Hospital, Ehime, Japan. Electronic address: nomoto1492@nifty.com.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116833']
189,32332363,Original Research: Exploring the Effects of a Nurse-Initiated Diary Intervention on Post-Critical Care Posttraumatic Stress Disorder.,"BACKGROUND


Critical illness survivors may develop posttraumatic stress disorder (PTSD) following critical illness and hospitalization. Left untreated, PTSD may result in poor health outcomes.
PURPOSE


This study sought to examine the effects of a nurse-initiated diary intervention on PTSD development and symptom severity in critical illness survivors with varying levels of mentation.
METHODS


The study used a pretest-posttest control group design. Patients who were hospitalized in a critical care unit for more than 24 hours were recruited at a single medical center with two such units. All participants completed a pretest on day 2 of critical care hospitalization; the intervention group participants also received a diary. All participants received a posttest one month after critical care discharge. The variables examined were PTSD severity and symptoms of avoidance, intrusion, and hyperarousal. Variables were measured using the Impact of Event Scale-Revised. Diaries were written by the patient, visitors, and interdisciplinary team members, and kept by the patient.
RESULTS


A total of 134 participants completed the study. The intervention group participants experienced significantly fewer PTSD symptoms than the control group participants. PTSD was found to be of concern in 35 (26%) of all participants: five in the intervention group and 30 in the control group.
CONCLUSIONS


For critical illness survivors, a collaborative diary-writing intervention during hospitalization and after discharge can mitigate post-critical care PTSD. Participants who received diaries had a lower incidence of PTSD symptoms than controls; and at follow-up, they indicated that the diary intervention was worthwhile. We recommend the use of collaborative diary writing to help critical illness survivors in working through their experiences.",2020,The intervention group participants experienced significantly fewer PTSD symptoms than the control group participants.,"['Patients who were hospitalized in a critical care unit for more than 24 hours were recruited at a single medical center with two such units', '134 participants completed the study', 'critical illness survivors with varying levels of mentation', 'Post-Critical Care Posttraumatic Stress Disorder']","['Nurse-Initiated Diary Intervention', 'nurse-initiated diary intervention', 'collaborative diary writing']","['PTSD severity and symptoms of avoidance, intrusion, and hyperarousal', 'PTSD symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4552570', 'cui_str': 'Hyperarousal'}]",134.0,0.0386469,The intervention group participants experienced significantly fewer PTSD symptoms than the control group participants.,"[{'ForeName': 'Lorrie', 'Initials': 'L', 'LastName': 'Torres', 'Affiliation': 'Lorrie Torres is a hospital nursing supervisor at Tripler Army Medical Center in Honolulu, HI, where Gordon West is deputy chief of the Center for Nursing Science and Clinical Inquiry. Francine Nelson is associate dean of the graduate and doctoral programs in the School of Nursing, University of Phoenix. Contact author: Lorrie Torres, lorrie.c.torres.civ@mail.mil. The authors have disclosed no potential conflicts of interest, financial or otherwise.'}, {'ForeName': 'Francine', 'Initials': 'F', 'LastName': 'Nelson', 'Affiliation': ''}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'West', 'Affiliation': ''}]",The American journal of nursing,['10.1097/01.NAJ.0000662804.81454.66']
190,32335343,"Safety and efficacy of memantine for multiple sclerosis-related fatigue: A pilot randomized, double-blind placebo-controlled trial.","BACKGROUND


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


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


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


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


This trial failed to prove any clinical efficacy of memantine for the management of MS-related fatigue. Although memantine was generally well-tolerated, adverse events were among the major causes of dropout in this study.",2020,"The mean [95% CI] absolute change in MFIS scores from baseline did not differ significantly between the memantine (-5.8 [-12.7 to 1.0]) and placebo (-4.0 [-10.6 to 2.7]) groups (between-group difference: -1.9 [-11.7 to 7.8], P = .702).","['multiple sclerosis-related fatigue', 'Sixteen patients in the memantine group and 24 patients in the', 'patients with MS', 'Sixty-four patients', 'patients with multiple sclerosis (MS', 'Eligible patients with relapsing-remitting MS (RRMS) according to the McDonald criteria']","['placebo', 'memantine']","['MFIS scores', 'tolerated, adverse events', 'Safety and efficacy', 'serious adverse events', 'safety and efficacy', 'severity of fatigue', 'dizziness and sedation', 'Modified Fatigue Impact Scale (MFIS']","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2960438', 'cui_str': 'Fatigue impact scale score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C2733557', 'cui_str': 'Fatigue impact scale'}]",64.0,0.542728,"The mean [95% CI] absolute change in MFIS scores from baseline did not differ significantly between the memantine (-5.8 [-12.7 to 1.0]) and placebo (-4.0 [-10.6 to 2.7]) groups (between-group difference: -1.9 [-11.7 to 7.8], P = .702).","[{'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Falsafi', 'Affiliation': 'Department of Neurology, Alavi Hospital, Ardabil University of Medical Sciences, Ardabil, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Tafakhori', 'Affiliation': 'Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elmira', 'Initials': 'E', 'LastName': 'Agah', 'Affiliation': ""Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran; NeuroImmunology Research Association (NIRA), Universal Scientific Education and Research Network (USERN), Tehran, Iran.""}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Mojarrad', 'Affiliation': 'School of medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reihaneh', 'Initials': 'R', 'LastName': 'Dehghani', 'Affiliation': 'Molecular Immunology Research Center, School of Medicine, Tehran University of Medical Science, Tehran 1419783151, Iran; Network of Immunity in Infection, Malignancy, and Autoimmunity (NIIMA), Universal Scientific Education and Research Network (USERN), Los Angeles, CA 90001, USA.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Ghaffarpour', 'Affiliation': 'Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: ghafarpour@tums.ac.ir.'}, {'ForeName': 'Vajiheh', 'Initials': 'V', 'LastName': 'Aghamollaii', 'Affiliation': 'Department of Neurology, Roozbeh Hospital, Tehran University of Medical Sciences, Roozbeh Hospital, Tehran, Iran.'}, {'ForeName': 'Seyed Vahid', 'Initials': 'SV', 'LastName': 'Mousavi', 'Affiliation': ""Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran; NeuroImmunology Research Association (NIRA), Universal Scientific Education and Research Network (USERN), Tehran, Iran.""}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Fouladi', 'Affiliation': ""Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Pourghaz', 'Affiliation': 'Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pargol', 'Initials': 'P', 'LastName': 'Balali', 'Affiliation': ""Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Harirchian', 'Affiliation': 'Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: harirchm@tums.ac.ir.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116844']
191,32289325,Caloric compensation and appetite control in children of different weight status and predisposition to obesity.,"To prevent childhood obesity it is critical to identify behavioral phenotypes for overeating, especially among children who are predisposed to obesity. We examined caloric compensation and appetite control in 212 normal-weight (NW) and obese (OB) children, ages 7 to 9, who were at high risk (HR) or low risk (LR) for obesity based on maternal obesity. In a within-subjects crossover design, children ate breakfast, lunch, dinner, and snacks in the laboratory once a week for two weeks. Children's percentage compensation index (%COMPX) was computed at breakfast. Twenty-five minutes before breakfast, children received one of two compulsory preloads, which varied in energy density (ED) and caloric content [Low ED (LED): 1.00 kcal/g; 100 kcal; High ED (HED): 1.60 kcal/g; 160 kcal]. Children's appetite was measured hourly using Visual Analog Scales, which were used to compute 3-h post-prandial area under the curve (AUCs) after breakfast and the satiety quotient (SQ), which allows between-group comparisons of a fixed amount of a food's potency to reduce appetite sensations per unit of intake. There were no significant differences in %COMPX, SQ, or AUC among LR-NW, HR-NW, and HR-OB children (P > 0.10). SQs for Hunger and Prospective Consumption were higher and SQ for Fullness lower after consuming the LED compared to the HED preload (P < 0.009). Further, the SQ and AUC for Desire to Eat and AUC for Prospective Consumption significantly predicted energy intake during the remainder of the day (P < 0.03). In this study, HR-NW children did not differ from LR-NW or HR-OB children in their caloric compensation or appetite control. Foods with a high satiating effect may facilitate appetite control and help to moderate daily energy intake in all children, including at-risk children.",2020,SQs for Hunger and Prospective Consumption were higher and SQ for Fullness lower after consuming the LED compared to the HED preload (P < 0.009).,"['212 normal-weight (NW) and obese (OB) children, ages 7 to 9, who were at high risk (HR) or low risk (LR) for obesity based on maternal obesity', 'children who are predisposed to obesity', 'children of different weight status and predisposition to obesity']","['caloric content [Low ED (LED): 1.00\u202fkcal/g; 100\u202fkcal; High ED (HED', 'Caloric compensation and appetite control']","[""Children's percentage compensation index"", 'COMPX, SQ, or AUC among LR-NW, HR-NW, and HR-OB children', ""Children's appetite"", 'SQs for Hunger and Prospective Consumption', 'energy intake']","[{'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0746977', 'cui_str': 'Maternal Obesity'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}]","[{'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0152057', 'cui_str': 'Compensation'}, {'cui': 'C0003622', 'cui_str': 'Appetite control'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0152057', 'cui_str': 'Compensation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",212.0,0.0314051,SQs for Hunger and Prospective Consumption were higher and SQ for Fullness lower after consuming the LED compared to the HED preload (P < 0.009).,"[{'ForeName': 'Tanja V E', 'Initials': 'TVE', 'LastName': 'Kral', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Department of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, PA, USA. Electronic address: tkral@nursing.upenn.edu.'}, {'ForeName': 'Reneé H', 'Initials': 'RH', 'LastName': 'Moore', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Chittams', 'Affiliation': 'Department of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': ""O'Malley"", 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Jones', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Quinn', 'Affiliation': 'Department of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Jennifer O', 'Initials': 'JO', 'LastName': 'Fisher', 'Affiliation': 'Department of Social and Behavioral Sciences, College of Public Health, Temple University, Philadelphia, PA, USA.'}]",Appetite,['10.1016/j.appet.2020.104701']
192,32328036,The Optimized Calculation Method for Insulin Dosage in an Insulin Tolerance Test (ITT): A Randomized Parallel Control Study.,"Objective:  To explore the most suitable calculation method for insulin dosage in an insulin tolerance test (ITT) and to evaluate the clinical application value of the optimization coefficient (γ).  Methods:  In this study, 140 adult patients with congenital growth hormone deficiency (GHD) or acquired hypopituitarism were randomized into the following two groups: the conventional group ( n  = 70) and the optimized group ( n  = 70). Oral glucose tolerance tests (OGTTs), insulin release tests (IRTs), and ITTs were conducted. For ITTs, insulin doses were the product of body weight (kg) and related coefficient (0.15 IU/kg for the control group and γ IU/kg for the optimized group, respectively). Notably, γ was defined as -0.034 + 0.000176 × AUC INS  + 0.009846 × BMI, which was based on our previous study.  Results:  In the ITTs, the rate of achieving adequate hypoglycemia with a single insulin dose was significantly higher for the optimized group compared with the conventional group (92.9 vs. 60.0%,  P  < 0.001). The optimized group required higher initial doses of insulin (0.23 IU/kg). Meanwhile, the two groups did not differ significantly in their nadir blood glucose (1.9 vs. 1.9 mmol/L,  P  = 0.828).  Conclusion:  This study confirmed that the proposed optimized calculation method for insulin dosage in ITTs led to more efficient hypoglycemia achievement, without increasing the incidence of serious adverse events.",2020,"In the ITTs, the rate of achieving adequate hypoglycemia with a single insulin dose was significantly higher for the optimized group compared with the conventional group (92.9 vs. 60.0%,  P  < 0.001).",['140 adult patients with congenital growth hormone deficiency (GHD) or acquired hypopituitarism'],['Insulin Tolerance Test (ITT'],"['rate of achieving adequate hypoglycemia', 'Oral glucose tolerance tests (OGTTs), insulin release tests (IRTs), and ITTs', 'nadir blood glucose']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0271561', 'cui_str': 'Growth hormone deficiency'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0020635', 'cui_str': 'Hypopituitarism'}]","[{'cui': 'C0236287', 'cui_str': 'Insulin tolerance test'}]","[{'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}]",140.0,0.0430821,"In the ITTs, the rate of achieving adequate hypoglycemia with a single insulin dose was significantly higher for the optimized group compared with the conventional group (92.9 vs. 60.0%,  P  < 0.001).","[{'ForeName': 'Yuwen', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrine and Metabolic Diseases, Ruijin Hospital North, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Shouyue', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'Department of Endocrine and Metabolic Diseases, Ruijin Hospital North, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Huiying', 'Initials': 'H', 'LastName': 'Jia', 'Affiliation': 'Department of Endocrine and Metabolic Diseases, Ruijin Hospital North, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Qi', 'Affiliation': 'Department of Endocrine and Metabolic Diseases, Ruijin Hospital North, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrine and Metabolic Diseases, Ruijin Hospital North, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Department of Endocrine and Metabolic Diseases, Ruijin Hospital North, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yuhong', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Endocrine and Metabolic Diseases, Ruijin Hospital North, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Weiqing', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Medical Genomics, National Clinical Research Center for Metabolic Diseases, Collaborative Innovation Center of Systems Biomedicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Ning', 'Affiliation': 'State Key Laboratory of Medical Genomics, National Clinical Research Center for Metabolic Diseases, Collaborative Innovation Center of Systems Biomedicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}]",Frontiers in endocrinology,['10.3389/fendo.2020.00202']
193,32334615,Effectiveness of a multi-level intervention to reduce men's perpetration of intimate partner violence: a cluster randomised controlled trial.,"BACKGROUND


Men's perpetration of intimate partner violence (IPV) limits gains in health and wellbeing for populations globally. Largely informal, rapidly expanding peri-urban settlements, with limited basic services such as electricity, have high prevalence rates of IPV. Evidence on how to reduce men's perpetration, change social norms and patriarchal attitudes within these settings is limited. Our cluster randomised controlled trial aimed to determine the effectiveness of the Sonke CHANGE intervention in reducing use of sexual and/or physical IPV and severity of perpetration by men aged 18-40 years over 2 years.
METHODOLOGY


The theory-based intervention delivered activities to bolster community action, including door-to-door discussions, workshops, drawing on the CHANGE curriculum, and deploying community action teams over 18 months. In 2016 and 2018, we collected data from a cohort of men, recruited from 18 clusters; nine were randomised to receive the intervention, while the nine control clusters received no intervention. A self-administered questionnaire, using audio-computer assisted software, asked about sociodemographics, gender attitudes, mental health, and the use and severity of IPV. We conducted an intention-to-treat analysis at the cluster level comparing the expected risk to observed risk of using IPV while controlling for baseline characteristics. A secondary analysis used latent classes (LCA) of men to see whether there were differential effects of the intervention for subgroups of men.
RESULTS


Of 2406 men recruited, 1458 (63%) were followed to 2 years. Overall, we saw a reduction in men's reports of physical, sexual and severe IPV from baseline to endpoint (40.2% to 25.4%, 31.8% to 15.8%, and 33.4% to 18.2%, respectively). Intention-to-treat analysis showed no measurable differences between intervention and control clusters for primary IPV outcomes. Difference in the cluster-level proportion of physical IPV perpetration was 0.002 (95% confidence interval [CI] - 0.07 to 0.08). Similarly, differences between arms for sexual IPV was 0.01 (95% CI - 0.04 to 0.06), while severe IPV followed a similar pattern (Diff = 0.01; 95% CI - 0.05 to 0.07). A secondary analysis using LCA suggests that among the men living in intervention communities, there was a greater reduction in IPV among less violent and more law abiding men than among more highly violent men, although the differences did not reach statistical significance.
CONCLUSION


The intervention, when implemented in a peri-urban settlement, had limited effect in reducing IPV perpetrated by male residents. Further analysis showed it was unable to transform entrenched gender attitudes and use of IPV by those men who use the most violence, but the intervention showed promise for men who use violence less.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02823288. Registered on 30 June 2016.",2020,"The intervention, when implemented in a peri-urban settlement, had limited effect in reducing IPV perpetrated by male residents.","['Of 2406 men recruited, 1458 (63%) were followed to 2 years', 'In 2016 and 2018, we collected data from a cohort of men, recruited from 18 clusters; nine', ""Men's perpetration of intimate partner violence (IPV) limits gains in health and wellbeing for populations globally"", 'by men aged 18-40\u2009years over 2 years', ""men's perpetration of intimate partner violence""]","['multi-level intervention', 'Sonke CHANGE intervention']","['severe IPV', 'IPV', 'sexual IPV', 'sexual and/or physical IPV and severity of perpetration', 'physical, sexual and severe IPV']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205455', 'cui_str': '9'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",2406.0,0.183564,"The intervention, when implemented in a peri-urban settlement, had limited effect in reducing IPV perpetrated by male residents.","[{'ForeName': 'Nicola J', 'Initials': 'NJ', 'LastName': 'Christofides', 'Affiliation': 'Faculty of Health Sciences, School of Public Health, University of the Witwatersrand, 27 St Andrews Rd, Parktown, Johannesburg, 2193, South Africa. nicola.christofides@wits.ac.za.'}, {'ForeName': 'Abigail M', 'Initials': 'AM', 'LastName': 'Hatcher', 'Affiliation': 'Faculty of Health Sciences, School of Public Health, University of the Witwatersrand, 27 St Andrews Rd, Parktown, Johannesburg, 2193, South Africa.'}, {'ForeName': 'Dumisani', 'Initials': 'D', 'LastName': 'Rebombo', 'Affiliation': 'Sonke Gender Justice, Juta Street, Braamfontein, Johannesburg, South Africa.'}, {'ForeName': 'Ruari-Santiago', 'Initials': 'RS', 'LastName': 'McBride', 'Affiliation': 'Faculty of Health Sciences, School of Public Health, University of the Witwatersrand, 27 St Andrews Rd, Parktown, Johannesburg, 2193, South Africa.'}, {'ForeName': 'Shehnaz', 'Initials': 'S', 'LastName': 'Munshi', 'Affiliation': 'Faculty of Health Sciences, School of Public Health, University of the Witwatersrand, 27 St Andrews Rd, Parktown, Johannesburg, 2193, South Africa.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Pino', 'Affiliation': 'Sonke Gender Justice, Juta Street, Braamfontein, Johannesburg, South Africa.'}, {'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'Abdelatif', 'Affiliation': 'South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Peacock', 'Affiliation': 'Sonke Gender Justice, Juta Street, Braamfontein, Johannesburg, South Africa.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Levin', 'Affiliation': 'Faculty of Health Sciences, School of Public Health, University of the Witwatersrand, 27 St Andrews Rd, Parktown, Johannesburg, 2193, South Africa.'}, {'ForeName': 'Rachel K', 'Initials': 'RK', 'LastName': 'Jewkes', 'Affiliation': 'Faculty of Health Sciences, School of Public Health, University of the Witwatersrand, 27 St Andrews Rd, Parktown, Johannesburg, 2193, South Africa.'}]",Trials,['10.1186/s13063-020-4185-7']
194,32283187,Mediators of intervention effects on dietary fat intake in low-income overweight or obese women with young children.,"PURPOSE


We investigated whether autonomous motivation and self-efficacy might mediate the association between a lifestyle behavior intervention and dietary fat intake in low-income overweight or obese women with young children.
METHODS


Participants were randomized to an intervention or comparison group. Intervention participants received a 16-week intervention aimed to prevent weight gain through promotion of stress management, healthy eating and physical activity. During the intervention phase, participants viewed a designated video lesson at home and dialed in a peer support group teleconference every week (weeks 1-4) then every other week (weeks 5-16). Potential mediation effects were analyzed using sequential mixed-effects linear models and path analysis.
RESULTS


The intervention led to increased autonomous motivation (β = 0.34, standard error [SE] = 0.15, P = 0.005), which subsequently increased self-efficacy (β = 0.18, SE = 0.35, P < 0.001), and higher levels of self-efficacy were associated with decreased dietary fat intake (β = -0.22, SE = 0.28, P < 0.001). In other words, autonomous motivation and self-efficacy mediated the association between the lifestyle behavior intervention and dietary fat intake.
CONCLUSION


To decrease dietary fat intake for low-income overweight or obese women with young children, strategies, such as those promoting peer encouragement, may be warranted in interventions to enhance autonomous motivation and/or practical skills for increasing self-efficacy.",2020,"The intervention led to increased autonomous motivation (β = 0.34, standard error [SE] = 0.15, P = 0.005), which subsequently increased self-efficacy (β = 0.18, SE = 0.35, P < 0.001), and higher levels of self-efficacy were associated with decreased dietary fat intake (β = -0.22, SE = 0.28, P < 0.001).","['Participants', 'low-income overweight or obese women with young children']","['16-week intervention aimed to prevent weight gain through promotion of stress management, healthy eating and physical activity', 'lifestyle behavior intervention and dietary fat intake']","['dietary fat intake', 'autonomous motivation', 'self-efficacy', 'higher levels of self-efficacy']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0425440', 'cui_str': 'Dietary fat intake'}]","[{'cui': 'C0425440', 'cui_str': 'Dietary fat intake'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0336699,"The intervention led to increased autonomous motivation (β = 0.34, standard error [SE] = 0.15, P = 0.005), which subsequently increased self-efficacy (β = 0.18, SE = 0.35, P < 0.001), and higher levels of self-efficacy were associated with decreased dietary fat intake (β = -0.22, SE = 0.28, P < 0.001).","[{'ForeName': 'Mei-Wei', 'Initials': 'MW', 'LastName': 'Chang', 'Affiliation': 'The Ohio State University College of Nursing, 1585 Neil Avenue, Columbus, OH, 43210, USA. Electronic address: chang.1572@osu.edu.'}, {'ForeName': 'Alai', 'Initials': 'A', 'LastName': 'Tan', 'Affiliation': 'The Ohio State University College of Nursing, 1585 Neil Avenue, Columbus, OH, 43210, USA.'}, {'ForeName': 'Jiying', 'Initials': 'J', 'LastName': 'Ling', 'Affiliation': 'Michigan State University College of Nursing, 1355 Bogue St, East Lansing, MI, 48824, USA. Electronic address: lingjiyi@msu.edu.'}, {'ForeName': 'Duane T', 'Initials': 'DT', 'LastName': 'Wegener', 'Affiliation': 'The Ohio State University Department of Psychology, 1835 Neil Avenue, Columbus, OH, 43210, USA. Electronic address: wegener.1@osu.edu.'}, {'ForeName': 'Lorraine B', 'Initials': 'LB', 'LastName': 'Robbins', 'Affiliation': 'Michigan State University College of Nursing, 1355 Bogue St, East Lansing, MI, 48824, USA. Electronic address: robbin76@msu.edu.'}]",Appetite,['10.1016/j.appet.2020.104700']
195,32311695,Efficacy and Safety of the 9-mm Intrabronchial Valve in Patients with Advanced Emphysema.,"BACKGROUND


Endoscopic valve therapy aims at lung volume reduction that is associated with improved lung function, exercise tolerance and quality of life in emphysema patients. The size of intrabronchial valves of the Spiration® Valve System (SVS) selected to achieve lobar occlusion may have an influence on treatment outcomes.
METHODS


49 severe emphysema patients (M/F: 24/25, age: 64 ± 7 years), with complete interlobar fissures on the side intended to be treated, underwent treatment with at least one 9-mm intrabronchial valve implantation at 3 centers and were followed up at 30, 90 and 180 days after intervention. Changes in pulmonary function tests (PFT), 6-min walk test (6MWT), modified Medical Research Council (mMRC) dyspnea scale and chronic obstructive pulmonary disease assessment test scores as well as possible complications were recorded.
RESULTS


Forced expiratory volume in 1 s (FEV1) improved significantly over the 6-month period of the study, and the proportion of patients achieving a minimal clinically important difference (MCID) for FEV1 was 46.4% at 6 months. Regarding the remaining PFT values, the changes were not statistically significant at 6 months, but when looking at the MCIDs, 44.4% of the patients achieved the MCID decrease for residual volume. The 6MWT distance also improved statistically significantly, and an MCID increase of ≥26 m was reached by 41.7% of the patients. Furthermore, there was a statistically significant improvement in the mMRC score. The incidence of pneumothoraxes requiring drainage was 26.5% while a valve dislocation rate of 24% was observed but only in the lower lobes.
CONCLUSIONS


Endoscopic lung volume reduction with the 9-mm SVS valves was associated with statistically significant but modest improvement of FEV1, mMRC and 6MWT up to 6 months after intervention. These results were accompanied by an anticipated and acceptable risk profile. The relative increased incidence of device dislocation observed needs to be further elucidated.",2020,"The 6MWT distance also improved statistically significantly, and an MCID increase of ≥26 m was reached by 41.7% of the patients.","['49 severe emphysema patients (M/F: 24/25, age: 64 ± 7 years), with complete interlobar fissures on the side intended to be treated, underwent treatment with at least one 9-mm intrabronchial valve implantation at 3 centers and were followed up at 30, 90 and 180 days after intervention', 'Patients with Advanced Emphysema', 'emphysema patients']",['9-mm Intrabronchial Valve'],"['Forced expiratory volume in 1 s (FEV1', 'Efficacy and Safety', 'MCID increase of ≥26 m', 'valve dislocation rate', 'FEV1, mMRC and 6MWT', 'lung function, exercise tolerance and quality of life', 'pulmonary function tests (PFT), 6-min walk test (6MWT), modified Medical Research Council (mMRC) dyspnea scale and chronic obstructive pulmonary disease assessment test scores', 'incidence of pneumothoraxes requiring drainage', 'mMRC score', '6MWT distance', 'MCID decrease for residual volume']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0013990', 'cui_str': 'Emphysema'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332469', 'cui_str': 'Fissure'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1512914', 'cui_str': 'Intrabronchial route'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C1512914', 'cui_str': 'Intrabronchial route'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}]","[{'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4277733', 'cui_str': 'Minimal Clinically Important Difference'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0012691', 'cui_str': 'Dislocation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2960692', 'cui_str': 'Chronic obstructive pulmonary disease assessment test score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume'}]",,0.0420869,"The 6MWT distance also improved statistically significantly, and an MCID increase of ≥26 m was reached by 41.7% of the patients.","[{'ForeName': 'Konstantina', 'Initials': 'K', 'LastName': 'Kontogianni', 'Affiliation': 'Thoraxklinik, University of Heidelberg, Heidelberg, Germany, kkontogianni@gmail.com.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Gompelmann', 'Affiliation': 'Thoraxklinik, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Arschang', 'Initials': 'A', 'LastName': 'Valipour', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, North Hospital Vienna, Vienna, Austria.'}, {'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Gerovasili', 'Affiliation': 'Queen Elizabeth Hospital, University Hospitals Birmingham NHS Trust, Birmingham, United Kingdom.'}, {'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Schuhmann', 'Affiliation': 'Thoraxklinik, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Stanzel', 'Affiliation': 'Lungenklinik Hemer, Hemer, Germany.'}, {'ForeName': 'Felix J F', 'Initials': 'FJF', 'LastName': 'Herth', 'Affiliation': 'Thoraxklinik, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Eberhardt', 'Affiliation': 'Thoraxklinik, University of Heidelberg, Heidelberg, Germany.'}]",Respiration; international review of thoracic diseases,['10.1159/000506521']
196,32330775,Treatment with intravenous immunoglobulin increases the level of small EVs in plasma of pregnant women with recurrent pregnancy loss.,"Extracellular vesicles (EVs), which are small cell-derived compartments, take part in numerous different physiological processes. The contents of EVs reveal the cell of origin and indicates pathophysiological states in different diseases. In pregnancy disorders, changes have been reported in the composition, bioactivity and concentration of placental and non-placental EVs. The purpose of this study was to monitor the effects on EVs in patients receiving intravenous immunoglobulin (IVIG) or placebo (albumin) treatment due to recurrent pregnancy loss (RPL). In a placebo-controlled trial study of IVIG treatment, plasma collected from 39 women with RPL were investigated using the Extracellular Vesicle Array (EV Array). Plasma was sampled consecutively (from gestational week (GW) 5) and the protein phenotypes of the smaller EVs (sEVs) were analyzed for the presence of 34 markers. The levels of sEVs or changes in their levels in early pregnancy were correlated with treatment. There was statistically significant increased levels of sEVs in patients who received IVIG versus placebo. In conclusion, the treatment with high-doses of IVIG clearly boosted the production and release of sEVs to the circulation; however, the biological role of this boost remains to be clarified in further studies.",2020,There was statistically significant increased levels of sEVs in patients who received IVIG versus placebo.,"['pregnant women with recurrent pregnancy loss', '39 women with RPL', 'patients receiving']","['placebo', 'intravenous immunoglobulin', 'intravenous immunoglobulin (IVIG) or placebo (albumin']","['levels of sEVs or changes in their levels in early pregnancy', 'level of small EVs', 'levels of sEVs']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0156740', 'cui_str': 'Pregnancy in habitual aborter'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0001924', 'cui_str': 'albumin'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0560135', 'cui_str': 'eV'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C3894683', 'cui_str': 'Extracellular Vesicles'}]",39.0,0.0521941,There was statistically significant increased levels of sEVs in patients who received IVIG versus placebo.,"[{'ForeName': 'Malene Møller', 'Initials': 'MM', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Clinical Immunology, Aalborg University Hospital, Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark; Extracellular Vesicles Research Center Denmark (EVSearch.dk), Aalborg, Denmark. Electronic address: maljoe@rn.dk.'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Bæk', 'Affiliation': 'Department of Clinical Immunology, Aalborg University Hospital, Aalborg, Denmark; Extracellular Vesicles Research Center Denmark (EVSearch.dk), Aalborg, Denmark.'}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Sloth', 'Affiliation': 'Department of Clinical Immunology, Aalborg University Hospital, Aalborg, Denmark; Extracellular Vesicles Research Center Denmark (EVSearch.dk), Aalborg, Denmark.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Varming', 'Affiliation': 'Department of Clinical Immunology, Aalborg University Hospital, Aalborg, Denmark; Extracellular Vesicles Research Center Denmark (EVSearch.dk), Aalborg, Denmark.'}, {'ForeName': 'Ole Bjarne', 'Initials': 'OB', 'LastName': 'Christiansen', 'Affiliation': 'Department of Obstetrics and Gynecology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Nadja Emilie', 'Initials': 'NE', 'LastName': 'Ditlevsen', 'Affiliation': 'Department of Obstetrics and Gynecology, Aalborg University Hospital, Aalborg, Denmark; School of Medicine and Health, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Rajaratnam', 'Affiliation': 'Department of Obstetrics and Gynecology, Aalborg University Hospital, Aalborg, Denmark; School of Medicine and Health, Aalborg University, Aalborg, Denmark.'}]",Journal of reproductive immunology,['10.1016/j.jri.2020.103128']
197,32196749,"A randomized, double-blind, single-dose, three-arm, parallel group study to determine pharmacokinetic similarity of ABP 959 and eculizumab (Soliris ®  ) in healthy male subjects.","OBJECTIVES


ABP 959 is a proposed biosimilar to eculizumab, a monoclonal antibody targeting the human C5 complement protein. The objective of this randomized, double-blind, three-arm, study was to demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) similarity of ABP 959 relative to the eculizumab reference product (RP) in healthy adult male subjects.
METHODS


Eligible subjects aged 18-45 years were randomized to receive a 300-mg IV infusion of ABP 959, or FDA-licensed eculizumab (eculizumab US), or EU-authorized eculizumab (eculizumab EU). Primary PK endpoint was area under the total serum concentration-time curve from 0 to infinity (AUC 0-∞  ); primary PD endpoint was area between the effect curve (ABEC) of CH50-time data.
RESULTS


The geometric mean of PK and PD parameters were similar between ABP 959 versus eculizumab US and eculizumab EU; PK and PD similarity was established based on 90% confidence intervals of the geometric mean ratio being within prespecified equivalence margin of 0.8 and 1.25. The incidence of treatment-emergent adverse events was similar across groups. The incidence of binding anti-drug antibodies was similar across treatments; no subjects developed neutralizing antibodies.
CONCLUSIONS


This study demonstrated PK and PD similarity of ABP 959 to eculizumab RP; safety and immunogenicity profiles were also similar.",2020,"The incidence of binding anti-drug antibodies was similar across treatments; no subjects developed neutralizing antibodies.
","['healthy adult male subjects', 'Healthy Male Subjects', 'Eligible subjects aged 18-45 years']","['300-mg IV infusion of ABP 959, or FDA-licensed eculizumab (eculizumab US), or EU-authorized eculizumab (eculizumab EU', 'ABP 959 and Eculizumab (Soliris ®  ']","['geometric mean of PK and PD parameters', 'incidence of treatment-emergent adverse events', 'area under the total serum concentration-time curve', 'incidence of binding anti-drug antibodies', 'pharmacokinetic (PK) and pharmacodynamic (PD) similarity']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0023636', 'cui_str': 'Permits'}, {'cui': 'C1541483', 'cui_str': 'eculizumab'}, {'cui': 'C1744173', 'cui_str': 'Soliris'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}]",,0.331056,"The incidence of binding anti-drug antibodies was similar across treatments; no subjects developed neutralizing antibodies.
","[{'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Chow', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chien', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Daniel T', 'Initials': 'DT', 'LastName': 'Mytych', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Hanes', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}]",European journal of haematology,['10.1111/ejh.13411']
198,32234531,Which strategies to manage problem foods were related to weight loss in a randomized clinical trial?,"Individuals managing their weight are often faced with problem foods that are difficult to resist eating. In the context of a weight-loss intervention, we characterized the most commonly reported problem foods and the behavioral strategies used to manage them, and examined which strategies were related to weight loss. Women with overweight and obesity (N = 186) participated in a one-year randomized trial of three interventions (NCT01474759): standard advice to eat less food, choosing portions based on energy density, and using pre-portioned foods. At Months 0, 6, and 12 of the trial, participants listed the foods they found most problematic and reported the frequency of using eight behavioral strategies to control intake of these foods, including three practices for avoiding exposure to problem foods and three for consuming them but limiting intake. The responses showed that 82% of the top three problem foods were in the categories of sweet baked items, salty snacks, starchy side dishes, chocolate and candy, and ice cream. After one year, women who reported more frequently using the strategy of limiting portions of problem foods had a greater rate of weight loss (kg/week), regardless of their intervention group (p < 0.0001). Among women who limited portions of problem foods less frequently, those using pre-portioned foods had greater initial weight loss compared to the other two groups, but then regained weight at a greater rate (p < 0.0001). The three avoidance strategies for problem foods were reported to be frequently used but were not found to be related to weight loss. These results suggest that adopting and maintaining strategies to manage portions of problem foods, rather than avoiding exposure to them, can be a more useful approach for weight loss.",2020,The three avoidance strategies for problem foods were reported to be frequently used but were not found to be related to weight loss.,['Women with overweight and obesity'],"['standard advice to eat less food, choosing portions based on energy density, and using pre-portioned foods']","['rate of weight loss', 'categories of sweet baked items, salty snacks, starchy side dishes, chocolate and candy, and ice cream', 'initial weight loss']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0020498', 'cui_str': 'Disseminated idiopathic skeletal hyperostosis'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0006855', 'cui_str': 'Candy'}, {'cui': 'C0020747', 'cui_str': 'Ice cream'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]",186.0,0.0213008,The three avoidance strategies for problem foods were reported to be frequently used but were not found to be related to weight loss.,"[{'ForeName': 'Liane S', 'Initials': 'LS', 'LastName': 'Roe', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA. Electronic address: LSR7@psu.edu.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Rolls', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}]",Appetite,['10.1016/j.appet.2020.104687']
199,32336050,Three-Dimensional Flexible Endoscopy Can Facilitate Efficient and Reliable Endoscopic Hand Suturing: An ex-vivo Study.,"BACKGROUND/AIMS


Three-dimensional (3D) flexible endoscopy, a new imaging modality that provides a stereoscopic view, can facilitate endoscopic hand suturing (EHS), a novel intraluminal suturing technique. This ex-vivo pilot study evaluated the usefulness of 3D endoscopy in EHS.
METHODS


Four endoscopists (two certified, two non-certified) performed EHS in six sessions on a soft resin pad. Each session involved five stitches, under alternating 3D and two-dimensional (2D) conditions. Suturing time (sec/session), changes in suturing time, and accuracy of suturing were compared between 2D and 3D conditions.
RESULTS


The mean suturing time was shorter in 3D than in 2D (9.8±3.4 min/session vs. 11.2±5.1 min/session) conditions and EHS was completed faster in 3D conditions, particularly by non-certified endoscopists. The suturing speed increased as the 3D sessions progressed. Error rates (failure to grasp the needle, failure to thread the needle, and puncture retrial) in the 3D condition were lower than those in the 2D condition, whereas there was no apparent difference in deviation distance.
CONCLUSION


3D endoscopy may contribute to increasing the speed and accuracy of EHS in a short time period. Stereoscopic viewing during 3D endoscopy may help in efficient skill acquisition for EHS, particularly among novice endoscopists.",2020,"The mean suturing time was shorter in 3D than in 2D (9.8±3.4 min/session vs. 11.2±5.1 min/session) conditions and EHS was completed faster in 3D conditions, particularly by non-certified endoscopists.",[],"['Dimensional Flexible Endoscopy', 'Endoscopic Hand Suturing']","['speed and accuracy of EHS', 'Error rates (failure to grasp the needle, failure to thread the needle, and puncture retrial', 'deviation distance', 'Suturing time (sec/session), changes in suturing time, and accuracy of suturing', 'mean suturing time', 'suturing speed']",[],"[{'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C4319672', 'cui_str': 'Thread'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0059387', 'cui_str': 'staphylococcal enterotoxin C'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0176266,"The mean suturing time was shorter in 3D than in 2D (9.8±3.4 min/session vs. 11.2±5.1 min/session) conditions and EHS was completed faster in 3D conditions, particularly by non-certified endoscopists.","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Omori', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Goto', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kazutoshi', 'Initials': 'K', 'LastName': 'Higuchi', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takamitsu', 'Initials': 'T', 'LastName': 'Umeda', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Naohiko', 'Initials': 'N', 'LastName': 'Akimoto', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Suzuki', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kumiko', 'Initials': 'K', 'LastName': 'Kirita', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Eriko', 'Initials': 'E', 'LastName': 'Koizumi', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Noda', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Teppei', 'Initials': 'T', 'LastName': 'Akimoto', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Mitsuru', 'Initials': 'M', 'LastName': 'Kaise', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Iwakiri', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan.'}]",Clinical endoscopy,['10.5946/ce.2019.207']
200,32302930,"Attentional prioritization in dual-task walking: Effects of stroke, environment, and instructed focus.","BACKGROUND


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


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


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


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


Although dual-tasking slows walking speed and verbal responses to auditory stimuli in people with stroke, the effects are not considerably impacted by a more complex, distracting environment. Adults with and without stroke may have difficulty overriding the preferred attention allocation strategy during dual-task walking, especially for habitual dual-tasks such as walking while speaking. It may also be that the cognitive control strategy governing task prioritization is influenced by degree of cognitive engagement.",2020,"The dual-task attention allocation strategy was generally inflexible to instructed prioritization in adults with and without stroke in both environments, however, the volitional attention allocation strategy differed for the two dual-task conditions such that speech was prioritized in the speech-gait dual-task and gait appeared to be prioritized in the Stroop-gait dual-task.
","['Adults with and without stroke', 'adults with and without stroke', 'Adults with stroke (n = 29) as well as age-, gender-, and education-matched adults without stroke (n = 23) participated', 'people with stroke']",['explicit instruction about task prioritization (no-priority) and then with gait-priority instruction and Stroop/speech-priority instruction'],"['walking speed while generating spontaneous speech', 'Stroop reaction time', 'dual-task gait speed']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0439607', 'cui_str': 'Priorities'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0037817', 'cui_str': 'Speech'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205173', 'cui_str': 'Double'}]",23.0,0.0469792,"The dual-task attention allocation strategy was generally inflexible to instructed prioritization in adults with and without stroke in both environments, however, the volitional attention allocation strategy differed for the two dual-task conditions such that speech was prioritized in the speech-gait dual-task and gait appeared to be prioritized in the Stroop-gait dual-task.
","[{'ForeName': 'Prudence', 'Initials': 'P', 'LastName': 'Plummer', 'Affiliation': 'Department of Physical Therapy, MGH Institute of Health Professions, 36 1st Avenue, Boston, MA, 02129, United States. Electronic address: pplummer@mghihp.edu.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Altmann', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Jody', 'Initials': 'J', 'LastName': 'Feld', 'Affiliation': 'Department of Orthopaedic Surgery, Duke University, NC, United States.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Zukowski', 'Affiliation': 'Department of Physical Therapy, High Point University, High Point, NC, United States.'}, {'ForeName': 'Bijan', 'Initials': 'B', 'LastName': 'Najafi', 'Affiliation': 'Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Giuliani', 'Affiliation': 'Department of Allied Health Sciences, University of North Carolina at Chapel Hill, NC, United States.'}]",Gait & posture,['10.1016/j.gaitpost.2020.03.013']
201,32304981,Opioid overdose reversals using naloxone in New York City by people who use opioids: Implications for public health and overdose harm reduction approaches from a qualitative study.,"BACKGROUND


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


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


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


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


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


People who use opioids recognise three distinct and interconnected outcomes that may follow a successful opioid overdose reversal after intramuscular or intranasal administration of naloxone.","[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Parkin', 'Affiliation': ""National Addiction Centre, King's College London, 4 Windsor Walk, Denmark Hill SE5 8BB, United Kingdom. Electronic address: stephen.parkin@kcl.ac.uk.""}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Neale', 'Affiliation': ""National Addiction Centre, King's College London, 4 Windsor Walk, Denmark Hill SE5 8BB, United Kingdom; Centre for Social Research in Health, University of New South Wales, Sydney, NSW 2052, Australia.""}, {'ForeName': 'Caral', 'Initials': 'C', 'LastName': 'Brown', 'Affiliation': ""National Addiction Centre, King's College London, 4 Windsor Walk, Denmark Hill SE5 8BB, United Kingdom.""}, {'ForeName': 'Aimee N C', 'Initials': 'ANC', 'LastName': 'Campbell', 'Affiliation': 'Division on Substance Use Disorders, Columbia University Medical Center and New York State Psychiatric Institute, 1051 Riverside Drive, Unit 20, New York, NY 10032, United States.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Castillo', 'Affiliation': 'Division on Substance Use Disorders, Columbia University Medical Center and New York State Psychiatric Institute, 1051 Riverside Drive, Unit 20, New York, NY 10032, United States.'}, {'ForeName': 'Jermaine D', 'Initials': 'JD', 'LastName': 'Jones', 'Affiliation': 'Division on Substance Use Disorders, Columbia University Medical Center and New York State Psychiatric Institute, 1051 Riverside Drive, Unit 20, New York, NY 10032, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Strang', 'Affiliation': ""National Addiction Centre, King's College London, 4 Windsor Walk, Denmark Hill SE5 8BB, United Kingdom; South London and Maudsley NHS Foundation Trust, Maudsley Hospital, London SE5 8AZ, United Kingdom.""}, {'ForeName': 'Sandra D', 'Initials': 'SD', 'LastName': 'Comer', 'Affiliation': 'Division on Substance Use Disorders, Columbia University Medical Center and New York State Psychiatric Institute, 1051 Riverside Drive, Unit 20, New York, NY 10032, United States.'}]",The International journal on drug policy,['10.1016/j.drugpo.2020.102751']
202,32330277,Effect of High vs Low Doses of Chloroquine Diphosphate as Adjunctive Therapy for Patients Hospitalized With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection: A Randomized Clinical Trial.,"Importance


There is no specific antiviral therapy recommended for coronavirus disease 2019 (COVID-19). In vitro studies indicate that the antiviral effect of chloroquine diphosphate (CQ) requires a high concentration of the drug.
Objective


To evaluate the safety and efficacy of 2 CQ dosages in patients with severe COVID-19.
Design, Setting, and Participants


This parallel, double-masked, randomized, phase IIb clinical trial with 81 adult patients who were hospitalized with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection was conducted from March 23 to April 5, 2020, at a tertiary care facility in Manaus, Brazilian Amazon.
Interventions


Patients were allocated to receive high-dosage CQ (ie, 600 mg CQ twice daily for 10 days) or low-dosage CQ (ie, 450 mg twice daily on day 1 and once daily for 4 days).
Main Outcomes and Measures


Primary outcome was reduction in lethality by at least 50% in the high-dosage group compared with the low-dosage group. Data presented here refer primarily to safety and lethality outcomes during treatment on day 13. Secondary end points included participant clinical status, laboratory examinations, and electrocardiogram results. Outcomes will be presented to day 28. Viral respiratory secretion RNA detection was performed on days 0 and 4.
Results


Out of a predefined sample size of 440 patients, 81 were enrolled (41 [50.6%] to high-dosage group and 40 [49.4%] to low-dosage group). Enrolled patients had a mean (SD) age of 51.1 (13.9) years, and most (60 [75.3%]) were men. Older age (mean [SD] age, 54.7 [13.7] years vs 47.4 [13.3] years) and more heart disease (5 of 28 [17.9%] vs 0) were seen in the high-dose group. Viral RNA was detected in 31 of 40 (77.5%) and 31 of 41 (75.6%) patients in the low-dosage and high-dosage groups, respectively. Lethality until day 13 was 39.0% in the high-dosage group (16 of 41) and 15.0% in the low-dosage group (6 of 40). The high-dosage group presented more instance of QTc interval greater than 500 milliseconds (7 of 37 [18.9%]) compared with the low-dosage group (4 of 36 [11.1%]). Respiratory secretion at day 4 was negative in only 6 of 27 patients (22.2%).
Conclusions and Relevance


The preliminary findings of this study suggest that the higher CQ dosage should not be recommended for critically ill patients with COVID-19 because of its potential safety hazards, especially when taken concurrently with azithromycin and oseltamivir. These findings cannot be extrapolated to patients with nonsevere COVID-19.
Trial Registration


ClinicalTrials.gov Identifier: NCT04323527.",2020,"Viral RNA was detected in 31 of 40 (77.5%) and 31 of 41 (75.6%) patients in the low-dosage and high-dosage groups, respectively.","['Enrolled patients had a mean (SD) age of 51.1 (13.9) years, and most (60 [75.3%]) were men', '81 adult patients who were hospitalized with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection was conducted from March 23 to April 5, 2020, at a tertiary care facility in Manaus, Brazilian Amazon', 'Older age (mean [SD] age, 54.7 [13.7] years vs 47.4 [13.3] years) and more heart disease (5 of 28 [17.9%] vs 0) were seen in the high-dose group', 'Patients Hospitalized With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2', 'patients with severe COVID-19']","['azithromycin and oseltamivir', 'high-dosage CQ ', 'low-dosage CQ ', 'Chloroquine Diphosphate', 'chloroquine diphosphate (CQ']","['participant clinical status, laboratory examinations, and electrocardiogram results', 'Viral RNA', 'reduction in lethality', 'Respiratory secretion', 'safety and efficacy', 'Viral respiratory secretion RNA detection', 'Infection', 'safety and lethality outcomes', 'instance of QTc interval', 'Lethality']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517562', 'cui_str': '13.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0055447', 'cui_str': 'Chloroquine phosphate'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0260877', 'cui_str': 'Laboratory examination'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0035736', 'cui_str': 'Viral RNA'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1532372', 'cui_str': 'Respiratory secretion'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0860814', 'cui_str': 'QTc'}]",81.0,0.0816988,"Viral RNA was detected in 31 of 40 (77.5%) and 31 of 41 (75.6%) patients in the low-dosage and high-dosage groups, respectively.","[{'ForeName': 'Mayla Gabriela Silva', 'Initials': 'MGS', 'LastName': 'Borba', 'Affiliation': 'Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Fernando Fonseca Almeida', 'Initials': 'FFA', 'LastName': 'Val', 'Affiliation': 'Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Vanderson Souza', 'Initials': 'VS', 'LastName': 'Sampaio', 'Affiliation': 'Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Marcia Almeida Araújo', 'Initials': 'MAA', 'LastName': 'Alexandre', 'Affiliation': 'Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Gisely Cardoso', 'Initials': 'GC', 'LastName': 'Melo', 'Affiliation': 'Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Brito', 'Affiliation': 'Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Maria Paula Gomes', 'Initials': 'MPG', 'LastName': 'Mourão', 'Affiliation': 'Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'José Diego', 'Initials': 'JD', 'LastName': 'Brito-Sousa', 'Affiliation': 'Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Djane', 'Initials': 'D', 'LastName': 'Baía-da-Silva', 'Affiliation': 'Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Marcus Vinitius Farias', 'Initials': 'MVF', 'LastName': 'Guerra', 'Affiliation': 'Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Ludhmila Abrahão', 'Initials': 'LA', 'LastName': 'Hajjar', 'Affiliation': 'Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rosemary Costa', 'Initials': 'RC', 'LastName': 'Pinto', 'Affiliation': 'Fundação de Vigilância em Saúde do Amazonas, Manaus, Brazil.'}, {'ForeName': 'Antonio Alcirley Silva', 'Initials': 'AAS', 'LastName': 'Balieiro', 'Affiliation': 'Instituto Leônidas and Maria Deane, Fiocruz Amazonas, Manaus, Brazil.'}, {'ForeName': 'Antônio Guilherme Fonseca', 'Initials': 'AGF', 'LastName': 'Pacheco', 'Affiliation': 'Programa de Computação Científica, Fiocruz, Rio de Janeiro, Brazil.'}, {'ForeName': 'James Dean Oliveira', 'Initials': 'JDO', 'LastName': 'Santos', 'Affiliation': 'Universidade Federal do Amazonas, Manaus, Brazil.'}, {'ForeName': 'Felipe Gomes', 'Initials': 'FG', 'LastName': 'Naveca', 'Affiliation': 'Instituto Leônidas and Maria Deane, Fiocruz Amazonas, Manaus, Brazil.'}, {'ForeName': 'Mariana Simão', 'Initials': 'MS', 'LastName': 'Xavier', 'Affiliation': 'Instituto Nacional de Infectologia Carlos Chagas-Fiocruz, Rio de Janeiro, Brazil.'}, {'ForeName': 'André Machado', 'Initials': 'AM', 'LastName': 'Siqueira', 'Affiliation': 'Instituto Nacional de Infectologia Carlos Chagas-Fiocruz, Rio de Janeiro, Brazil.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Schwarzbold', 'Affiliation': 'Universidade Federal de Santa Maria, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Júlio', 'Initials': 'J', 'LastName': 'Croda', 'Affiliation': 'Faculdade de Medicina da Universidade Federal do Mato Grosso do Sul, Campo Grande, Brazil.'}, {'ForeName': 'Maurício Lacerda', 'Initials': 'ML', 'LastName': 'Nogueira', 'Affiliation': 'Faculdade de Medicina de São José do Rio Preto, São Paulo, Brazil.'}, {'ForeName': 'Gustavo Adolfo Sierra', 'Initials': 'GAS', 'LastName': 'Romero', 'Affiliation': 'Universidade de Brasília, Brasília, Brazil.'}, {'ForeName': 'Quique', 'Initials': 'Q', 'LastName': 'Bassat', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Cor Jesus', 'Initials': 'CJ', 'LastName': 'Fontes', 'Affiliation': 'Universidade Federal de Mato Grosso, Mato Grosso, Brazil.'}, {'ForeName': 'Bernardino Cláudio', 'Initials': 'BC', 'LastName': 'Albuquerque', 'Affiliation': 'Faculdade de Medicina da Universidade Federal do Amazonas, Manaus, Brazil.'}, {'ForeName': 'Cláudio-Tadeu', 'Initials': 'CT', 'LastName': 'Daniel-Ribeiro', 'Affiliation': 'Instituto Oswaldo Cruz, Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.'}, {'ForeName': 'Wuelton Marcelo', 'Initials': 'WM', 'LastName': 'Monteiro', 'Affiliation': 'Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Marcus Vinícius Guimarães', 'Initials': 'MVG', 'LastName': 'Lacerda', 'Affiliation': 'Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA network open,['10.1001/jamanetworkopen.2020.8857']
203,32229250,An embedded mixed-methods study highlighted a lack of discussions on retention in clinical trial consultations.,"OBJECTIVES


This study investigated trial consultations to identify whether and to what extent discussions of retention are present.
STUDY DESIGN AND SETTING


This embedded mixed-methods study design included a purposive sample of audio-recorded trial consultations obtained from four sites of a large multicenter UK-based surgical RCT. Study participants included potential trial participants, trial surgeons (TSs), and research nurses (RNs).
RESULTS


Forty-four participants were included in this study: potential trial participants (n = 37); TSs (n = 4); and RNs (n = 3). Analysis revealed no discussion of retention across 79% of consultations. Of the remaining 21% where discussions of retention were present, only 3% (maximum) of the conversation related to retention. There was some evidence of good practice, but on the whole the discussions contained inaccuracies about timing and delivery of questionnaires and the right to withdraw often highlighted without providing trial consequences.
CONCLUSION


This study is the first to explore trial consultations for discussions of retention. It suggests that there may be room for improvement within current practice. Further research is required to determine the generalizability of the findings reported to other clinical trials.",2020,Analysis revealed no discussion of retention across 79% of consultations.,"['Study participants included potential trial participants, trial surgeons (TSs), and research nurses (RNs', 'purposive sample of audio-recorded trial consultations obtained from four sites of a large multicenter UK-based surgical RCT', 'Forty-four participants were included in this study: potential trial participants (n\xa0=\xa037); TSs (n\xa0=\xa04); and RNs (n\xa0=\xa03']",[],[],"[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0687693', 'cui_str': 'Research nurse'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C4319568', 'cui_str': '44'}]",[],[],44.0,0.176627,Analysis revealed no discussion of retention across 79% of consultations.,"[{'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Tunji-Ajayi', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, AB25 2ZD, UK.'}, {'ForeName': 'Eilidh M', 'Initials': 'EM', 'LastName': 'Duncan', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, AB25 2ZD, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Gillies', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, AB25 2ZD, UK. Electronic address: k.gillies@abdn.ac.uk.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2020.03.011']
204,32251766,Temperament profiles are associated with dietary behavior from childhood to adulthood.,"BACKGROUND AND OBJECTIVES


Temperament may be associated with eating behaviors over the lifespan. This study examined the association of toddlerhood temperament with dietary behavior and dietary intervention outcomes across 18 years.
METHODS


The study comprised 660 children (52% boys) from The Special Turku Intervention Project (STRIP), which is a longitudinal randomized controlled trial from the age of 7 months until the age of 20 years (1990-2010). Temperament was assessed using Carey temperament scales when the participants were 2 years of age. Latent profile analysis yielded three temperament groups, which were called negative/low regulation (19% of the children), neutral/average regulation (52%) and positive/high regulation (28%). Dietary behavior was examined from 2 to 20 years of age using food records, which were converted into a diet score (mean = 15.7, SD 4.6). Mixed random-intercept growth curve analysis was the main analytic method.
RESULTS


Dietary behavior showed a significant quadratic U-shaped curve over time (B for quadratic association = 0.39, P<.001; B for linear association = 0.09, P = 0.58). Children in the negative/low regulation temperament group had a lower diet score (less healthy diet) across the 18 years compared to children in the neutral/average or in the positive/high regulation group. Temperament was not associated with the rate of change in diet over time. Temperament did not have any interactive effects with the intervention (F [2, 627], P = 0.72).
CONCLUSION


Children with a temperament profile characterized by high negative mood, high irregularity and high intensity in emotion expression constitute a risk group for less healthy eating over the lifespan.",2020,"Temperament did not have any interactive effects with the intervention (F [2, 627], P = 0.72).
","['18 years', '660 children (52% boys) from The Special Turku Intervention Project (STRIP), which is a longitudinal randomized controlled trial from the age of 7 months until the age of 20 years (1990-2010']",[],"['lower diet score', 'Carey temperament scales', 'Dietary behavior']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0282440', 'cui_str': 'Randomized Controlled Trials as Topic'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039474', 'cui_str': 'Temperament'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",660.0,0.0437514,"Temperament did not have any interactive effects with the intervention (F [2, 627], P = 0.72).
","[{'ForeName': 'Jari', 'Initials': 'J', 'LastName': 'Lipsanen', 'Affiliation': 'Department of Psychology and Logopedics, Faculty of Medicine, University of Helsinki, Finland.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Elovainio', 'Affiliation': 'Department of Psychology and Logopedics, Faculty of Medicine, University of Helsinki, Finland; National Institute for Health and Welfare, Finland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hakulinen', 'Affiliation': 'Department of Psychology and Logopedics, Faculty of Medicine, University of Helsinki, Finland.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Tremblay', 'Affiliation': 'Healthy Active Living and Obesity Research Group, CHEO Research Institute, Ottawa, Canada.'}, {'ForeName': 'Suvi', 'Initials': 'S', 'LastName': 'Rovio', 'Affiliation': 'Research Centre of Applied and Preventive Cardiovascular Medicine, University of Turku, Finland.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Lagström', 'Affiliation': 'Department of Public Health, University of Turku, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Johanna M', 'Initials': 'JM', 'LastName': 'Jaakkola', 'Affiliation': 'Research Centre of Applied and Preventive Cardiovascular Medicine, University of Turku, Finland.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Jula', 'Affiliation': 'National Institute for Health and Welfare, Finland.'}, {'ForeName': 'Tapani', 'Initials': 'T', 'LastName': 'Rönnemaa', 'Affiliation': 'Department of Medicine, University of Turku and Division of Medicine, Turku University Hospital, Finland.'}, {'ForeName': 'Jorma', 'Initials': 'J', 'LastName': 'Viikari', 'Affiliation': 'Department of Medicine, University of Turku and Division of Medicine, Turku University Hospital, Finland.'}, {'ForeName': 'Harri', 'Initials': 'H', 'LastName': 'Niinikoski', 'Affiliation': 'Institute of Biomedicine, University of Turku, Department of Pediatrics and AdolescentMedicine, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Olli', 'Initials': 'O', 'LastName': 'Simell', 'Affiliation': 'Department of Medicine, University of Turku and Division of Medicine, Turku University Hospital, Finland.'}, {'ForeName': 'Olli T', 'Initials': 'OT', 'LastName': 'Raitakari', 'Affiliation': 'Research Centre of Applied and Preventive Cardiovascular Medicine, University of Turku, Finland; Centre for Population Health Research, University of Turku and Turku University Hospital, Finland; Department of Clinical Physiology and Nuclear Medicine, Turku University Hospital, Finland.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Pahkala', 'Affiliation': 'Research Centre of Applied and Preventive Cardiovascular Medicine, University of Turku, Finland; Paavo Nurmi Centre, Sports & Exercise Medicine Unit, Department of Health and Physical Activity, University of Turku, Finland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pulkki-Råback', 'Affiliation': 'Department of Psychology and Logopedics, Faculty of Medicine, University of Helsinki, Finland; Research Centre for Child Psychiatry, Faculty of Medicine, University of Turku, Finland. Electronic address: laura.pulkki-raback@helsinki.fi.'}]",Appetite,['10.1016/j.appet.2020.104681']
205,32251813,Is Full Endoscopic Lumbar Discectomy Less Invasive Than Conventional Surgery? A Randomized MRI Study.,"BACKGROUND


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


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


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


We found a significant difference in signal intensity of the paravertebral muscles between the FELD and OD groups, reflective of the minor surgical invasiveness of endoscopic discectomy. FELD resulted in less trauma to the paraspinal muscles, possibly also reducing inflammatory cytokine release and, therefore, is a valuable tool for spinal surgeons.",2020,"Median values for postoperative back pain were significantly lower for FELD patients (p-value=<0.001), as long as the median time from operation to patients autonomous mobilization (p-value=0.001).
","['50 patients with a single-level lumbar foraminal herniation, an invalidating radicular pain, and adequate imaging (postoperative MRI < 24 hours']","['transforaminal full-endoscopic lumbar discectomy (FELD) and open discectomy (OD', 'FELD']","['median preoperative and postoperative leg pain', 'Median values for postoperative back pain', 'signal intensity of paravertebral muscles', 'mean volume of paravertebral muscle signal alterations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0441996', 'cui_str': 'Foraminal'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0278147', 'cui_str': 'Radicular pain'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0439584', 'cui_str': '24 hours'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0206078', 'cui_str': 'Discectomy of spine'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",50.0,0.066437,"Median values for postoperative back pain were significantly lower for FELD patients (p-value=<0.001), as long as the median time from operation to patients autonomous mobilization (p-value=0.001).
","[{'ForeName': 'Leonello', 'Initials': 'L', 'LastName': 'Tacconi', 'Affiliation': 'Neurosurgical Department, Azienda Sanitaria Universitaria Integrata di Trieste, Trieste, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Signorelli', 'Affiliation': 'Division of Neurosurgery, Department of Basic Medical Sciences, Neurosciences and Sense Organs, University ""Aldo Moro"" of Bari, Bari, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Giordan', 'Affiliation': 'Neurosurgical Department, Azienda ULSS 2 Marca Trevigiana, Treviso, Veneto, Italy. Electronic address: enrico.giordan@aulss2.veneto.it.'}]",World neurosurgery,['10.1016/j.wneu.2020.03.123']
206,30625023,Piloting a Financial Counseling Intervention for Patients With Cancer Receiving Chemotherapy.,"PURPOSE


National organizations encourage communication about costs of cancer care; however, few data are available on health system models for identifying and assisting patients with financial distress (FD). We report the feasibility and acceptability of a financial counseling (FC) intervention for patients who receive chemotherapy at a comprehensive cancer center.
MATERIALS AND METHODS


Patients were randomly assigned 1:1 to FC or standard care. The FC arm received education, financial assistance screening, and an estimation tool with total billed charges and out-of-pocket (OOP) cost of one cycle of chemotherapy from a financial counselor through phone call and in-person visit. Participants completed measures of FD, health-related quality of life, and acceptability.
RESULTS


Ninety-five participants enrolled (mean age, 61 years; 72% white; 50% commercially insured), with a 32% attrition rate between assessments. Rates of completion for the phone call, in-person, and entire intervention were 98%, 47%, and 30%, respectively. The OOP estimation tool was considered understandable and acceptable to the majority of participants. No significant changes in FD were found between arms. Emotional functioning was negatively associated with having high FD (95% CI, -0.13379 to -0.013; P = .0189). Being married was associated with a decrease in log-odds of having high FD (β = -1.916; 95% CI, -3.358 to -0.475; P = .0092).
CONCLUSION


Implementation of an FC program that provides transparent cost data is feasible and acceptable. Incorporation of FC into clinical workflow, including phone counseling, is important to improve feasibility. Additional work is needed to develop tailored educational materials that are patient specific.",2019,"Emotional functioning was negatively associated with having high FD (95% CI, -0.13379 to -0.013","['patients with financial distress (FD', 'Ninety-five participants enrolled (mean age, 61 years; 72% white; 50% commercially insured), with a 32% attrition rate between assessments', 'patients who receive chemotherapy at a comprehensive cancer center', 'Patients With Cancer Receiving Chemotherapy']","['education, financial assistance screening, and an estimation tool with total billed charges and out-of-pocket (OOP) cost of one cycle of chemotherapy', 'Financial Counseling Intervention', 'financial counseling (FC) intervention', 'FC or standard care']","['FD, health-related quality of life, and acceptability', 'Emotional functioning', 'FD', 'log-odds of having high FD (β']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C3815933', 'cui_str': 'Expenditures, Out-of-Pocket'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",95.0,0.0380156,"Emotional functioning was negatively associated with having high FD (95% CI, -0.13379 to -0.013","[{'ForeName': 'Sheetal M', 'Initials': 'SM', 'LastName': 'Kircher', 'Affiliation': '1 Northwestern University, Chicago, IL.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Yarber', 'Affiliation': '1 Northwestern University, Chicago, IL.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Rutsohn', 'Affiliation': '1 Northwestern University, Chicago, IL.'}, {'ForeName': 'Yanina', 'Initials': 'Y', 'LastName': 'Guevara', 'Affiliation': '1 Northwestern University, Chicago, IL.'}, {'ForeName': 'Madison', 'Initials': 'M', 'LastName': 'Lyleroehr', 'Affiliation': '1 Northwestern University, Chicago, IL.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Alphs Jackson', 'Affiliation': '1 Northwestern University, Chicago, IL.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Walradt', 'Affiliation': '1 Northwestern University, Chicago, IL.'}, {'ForeName': 'Bijal', 'Initials': 'B', 'LastName': 'Desai', 'Affiliation': '1 Northwestern University, Chicago, IL.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Mulcahy', 'Affiliation': '1 Northwestern University, Chicago, IL.'}, {'ForeName': 'Aparna', 'Initials': 'A', 'LastName': 'Kalyan', 'Affiliation': '1 Northwestern University, Chicago, IL.'}, {'ForeName': 'Al B', 'Initials': 'AB', 'LastName': 'Benson', 'Affiliation': '1 Northwestern University, Chicago, IL.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Agulnik', 'Affiliation': '1 Northwestern University, Chicago, IL.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Mohindra', 'Affiliation': '1 Northwestern University, Chicago, IL.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'DeSouza', 'Affiliation': '2 Humana, Louisville, KY.'}, {'ForeName': 'Sofia F', 'Initials': 'SF', 'LastName': 'Garcia', 'Affiliation': '1 Northwestern University, Chicago, IL.'}]",Journal of oncology practice,['10.1200/JOP.18.00270']
207,30647436,"A pilot study of the effect of phospholipid curcumin on serum metabolomic profile in patients with non-alcoholic fatty liver disease: a randomized, double-blind, placebo-controlled trial.","BACKGROUND/OBJECTIVES


Curcumin, a natural polyphenol compound in the spice turmeric, has been found to have potent anti-oxidative and anti-inflammatory activity. Curcumin may treat non-alcoholic fatty liver disease (NAFLD) through its beneficial effects on biomarkers of oxidative stress (OS) and inflammation, which are considered as two feature of this disease. However, the effects of curcumin on NAFLD have been remained poorly understood. This investigation evaluated the effects of administrating curcumin on metabolic status in NAFLD patients.
SUBJECTS/METHODS


Fifty-eight NAFLD patients participated in a randomized, double-blind, placebo-controlled parallel design of study. The subjects were allocated randomly into two groups, which either received 250 mg phospholipid curcumin or placebo, one capsule per day for a period of 8 weeks. Fasting blood samples were taken from each subject at the start and end of the study period. Subsequently, metabolomics analysis was performed for serum samples using NMR.
RESULTS


Compared with the placebo, supplementing phospholipid curcumin resulted in significant decreases in serum including 3- methyl-2-oxovaleric acid, 3-hydroxyisobutyrate, kynurenine, succinate, citrate, α-ketoglutarate, methylamine, trimethylamine, hippurate, indoxyl sulfate, chenodeoxycholic acid, taurocholic acid, and lithocholic acid. This profile of metabolic biomarkers could distinguish effectively NAFLD subjects who were treated with curcumin and placebo groups, achieving value of 0.99 for an area under receiver operating characteristic curve (AUC).
CONCLUSIONS


Characterizing the serum metabolic profile of the patients with NAFLD at the end of the intervention using NMR-based metabolomics method indicated that the targets of curcumin treatment included some amino acids, TCA cycle, bile acids, and gut microbiota.",2019,"Compared with the placebo, supplementing phospholipid curcumin resulted in significant decreases in serum including 3- methyl-2-oxovaleric acid, 3-hydroxyisobutyrate, kynurenine, succinate, citrate, α-ketoglutarate, methylamine, trimethylamine, hippurate, indoxyl sulfate, chenodeoxycholic acid, taurocholic acid, and lithocholic acid.","['Fifty-eight NAFLD patients', 'NAFLD patients', 'patients with non-alcoholic fatty liver disease', 'NAFLD subjects who were treated with curcumin and placebo groups, achieving value of 0.99 for an area under receiver operating characteristic curve (AUC']","['placebo', '250\u2009mg phospholipid curcumin or placebo', 'Curcumin', 'curcumin', 'phospholipid curcumin']","['amino acids, TCA cycle, bile acids, and gut microbiota', 'serum metabolomic profile', 'metabolic status', 'serum including 3- methyl-2-oxovaleric acid, 3-hydroxyisobutyrate, kynurenine, succinate, citrate, α-ketoglutarate, methylamine, trimethylamine, hippurate, indoxyl sulfate, chenodeoxycholic acid, taurocholic acid, and lithocholic acid', 'Fasting blood samples']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4517488', 'cui_str': '0.99'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0031676', 'cui_str': 'Phospholipids'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}]","[{'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0005390', 'cui_str': 'Bile Acids'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1328813', 'cui_str': 'Metabolomic'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0945804', 'cui_str': '3-Hydroxyisobutyrate'}, {'cui': 'C0022818', 'cui_str': 'Benzenebutanoic acid, alpha,2-diamino-gamma-oxo-'}, {'cui': 'C0038617', 'cui_str': 'Succinates'}, {'cui': 'C0376259', 'cui_str': 'Citrate'}, {'cui': 'C0066318', 'cui_str': 'methylamine bisulfite'}, {'cui': 'C0077172', 'cui_str': 'trimethylamine'}, {'cui': 'C0019568', 'cui_str': 'Hippurates'}, {'cui': 'C0021210', 'cui_str': 'Indoxyl Sulfate'}, {'cui': 'C0008024', 'cui_str': 'Chenodeoxycholic Acid'}, {'cui': 'C0039358', 'cui_str': 'Cholyltaurine'}, {'cui': 'C0023875', 'cui_str': 'Isolithocholic Acid'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",58.0,0.255001,"Compared with the placebo, supplementing phospholipid curcumin resulted in significant decreases in serum including 3- methyl-2-oxovaleric acid, 3-hydroxyisobutyrate, kynurenine, succinate, citrate, α-ketoglutarate, methylamine, trimethylamine, hippurate, indoxyl sulfate, chenodeoxycholic acid, taurocholic acid, and lithocholic acid.","[{'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Chashmniam', 'Affiliation': 'Department of Chemistry, Sharif University of Technology, Tehran, Iran.'}, {'ForeName': 'Seyed Reza', 'Initials': 'SR', 'LastName': 'Mirhafez', 'Affiliation': 'Department of Basic Medical Sciences, Neyshabur University of Medical Sciences, Neyshabur, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Dehabeh', 'Affiliation': 'Department of Biology, Payamnoor University, Mashhad, Iran.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Hariri', 'Affiliation': 'Department of Basic Medical Sciences, Neyshabur University of Medical Sciences, Neyshabur, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Azimi Nezhad', 'Affiliation': 'Department of Basic Medical Sciences, Neyshabur University of Medical Sciences, Neyshabur, Iran.'}, {'ForeName': 'B Fatemeh', 'Initials': 'BF', 'LastName': 'Nobakht M Gh', 'Affiliation': 'Department of Basic Medical Sciences, Neyshabur University of Medical Sciences, Neyshabur, Iran. nobakhtf1@nums.ac.ir.'}]",European journal of clinical nutrition,['10.1038/s41430-018-0386-5']
208,32331584,"Corrigendum to ""van Bommel EJM, Muskiet MHA, van Baar MJB, et al. The renal hemodynamic effects of the SGLT2 inhibitor dapagliflozin are caused by post-glomerular vasodilatation rather than pre-glomerular vasoconstriction in metformin-treated patients with type 2 diabetes in the randomized, double-blind RED trial."" Kidney Int. 2020;97:202-212.",,2020,,['treated patients with type 2 diabetes'],"['metformin', 'SGLT2 inhibitor dapagliflozin']",['renal hemodynamic effects'],"[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0995255,,[],Kidney international,['10.1016/j.kint.2020.03.009']
209,32213777,Impact of Silicone Stent Placement in Symptomatic Airway Obstruction due to Non-Small Cell Lung Cancer - A French Multicenter Randomized Controlled Study: The SPOC Trial.,"BACKGROUND


Therapeutic bronchoscopy (TB) is an accepted strategy for the symptomatic management of central airway malignant obstruction. Stent insertion is recommended in case of extrinsic compression, but its value in preventing airway re-obstruction after endobronchial treatment without extrinsic compression is unknown.
OBJECTIVE


Silicone stent Placement in symptomatic airway Obstruction due to non-small cell lung Cancer (SPOC) is the first randomized controlled trial investigating the potential benefit of silicone stent insertion after successful TB in symptomatic malignant airway obstruction without extrinsic compression.
METHOD


We planned an inclusion of 170 patients in each group (stent or no stent) over a period of 3 years with 1-year follow-up. The 1-year survival rate without symptomatic local recurrence was the main endpoint. Recurrence rate, survival, quality of life, and stent tolerance were secondary endpoints. During 1-year follow-up, clinical events were monitored by flexible bronchoscopies and were evaluated by an independent expert committee.
RESULTS


Seventy-eight patients (mean age 65 years) were randomized into 2 arms: stents (n = 40) or no stents (n = 38) after IB. Consequently, our main endpoint could not be statistically answered. Improvement of dyspnea symptoms is noticeable in each group but lasts longer in the stent group. Stents do not change the survival curve but reduce unattended bronchoscopies. In the no stent group, 19 new TB were performed with 16 stents inserted contrasting with 10 rigid bronchoscopies and 3 stents placed in the stent group. In a subgroup analysis according to the oncologic management protocol following TB (first-line treatment and other lines or palliation), the beneficial effect of stenting on obstruction recurrence was highly significant (p < 0.002), but was not observed in the naïve group, free from first-line chemotherapy.
CONCLUSION


Silicone stent placement maintains the benefit of TB after 1 year on dyspnea score, obstruction's recurrence, and the need for new TB. Stenting does not affect the quality of life and is suggested for patients after failure of first-line chemotherapy. It is not suggested in patients without previous oncologic treatment.",2020,Improvement of dyspnea symptoms is noticeable in each group but lasts longer in the stent group.,"['Seventy-eight patients (mean age 65 years', 'central airway malignant obstruction', 'patients after failure of first-line chemotherapy', '170 patients in each group (stent or no stent) over a period of 3 years with 1-year follow-up', 'patients without previous oncologic treatment', 'symptomatic airway Obstruction due to non-small cell lung Cancer (SPOC']","['Silicone Stent Placement', 'Silicone stent placement', 'silicone stent insertion', 'no stents', 'Silicone stent Placement', 'Therapeutic bronchoscopy (TB']","['dyspnea symptoms', 'survival curve', 'obstruction recurrence', ""dyspnea score, obstruction's recurrence"", 'quality of life', '1-year survival rate without symptomatic local recurrence', 'Symptomatic Airway Obstruction', 'Recurrence rate, survival, quality of life, and stent tolerance']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0205478', 'cui_str': 'Oncologic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0001883', 'cui_str': 'Airway Obstruction'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0522776', 'cui_str': 'Placement of stent (procedure)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}]","[{'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0001883', 'cui_str': 'Airway Obstruction'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}]",,0.370104,Improvement of dyspnea symptoms is noticeable in each group but lasts longer in the stent group.,"[{'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Dutau', 'Affiliation': 'Department of Thoracic Oncology, Pleural Diseases, and Interventional Pulmonology, North University Hospital, Marseille, France, hdutau@ap-hm.fr.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Di Palma', 'Affiliation': 'Department of Clinical Investigations, University of Saint Etienne, Saint Etienne, France.'}, {'ForeName': 'Yoann', 'Initials': 'Y', 'LastName': 'Thibout', 'Affiliation': 'Department of Pulmonology and Thoracic Oncology, North University Hospital, Saint Etienne, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Febvre', 'Affiliation': 'Department of Pulmonology, Saint Antoine Hospital, Paris, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Cellerin', 'Affiliation': 'Department of Pulmonology, Nantes University Hospital, Nantes, France.'}, {'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Naudin', 'Affiliation': 'Department of Pulmonology, Nantes University Hospital, Nantes, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Hermant', 'Affiliation': 'Department of Pulmonology, Larrey University Hospital, Toulouse, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Vallerand', 'Affiliation': 'Department of Pulmonology, Maison Blanche University Hospital, Reims, France.'}, {'ForeName': 'Samy', 'Initials': 'S', 'LastName': 'Lachkar', 'Affiliation': 'Department of Pulmonology, Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Clément', 'Initials': 'C', 'LastName': 'Fournier', 'Affiliation': 'Department of Pulmonology, Calmette Hospital, CHU Lillle, F-59000, Lille, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Laroumagne', 'Affiliation': 'Department of Thoracic Oncology, Pleural Diseases, and Interventional Pulmonology, North University Hospital, Marseille, France.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Quiot', 'Affiliation': 'Department of Pulmonology, Cavale Blanche University Hospital, Brest, France.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Vergnon', 'Affiliation': 'Department of Pulmonology and Thoracic Oncology, North University Hospital, Saint Etienne, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Respiration; international review of thoracic diseases,['10.1159/000506601']
210,32332565,"Reply: The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial.",,2020,,['Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction'],"['Bupivacaine Hydrochloride', 'Liposomal Bupivacaine']",[],"[{'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine hydrochloride'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]",[],,0.187489,,"[{'ForeName': 'Austin Y', 'Initials': 'AY', 'LastName': 'Ha', 'Affiliation': 'Division of Plastic and Reconstructive Surgery Department of Anesthesiology Division of Plastic and Reconstructive Surgery, Washington University School of Medicine, Saint Louis, Mo.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Guffey', 'Affiliation': ''}, {'ForeName': 'Terence M', 'Initials': 'TM', 'LastName': 'Myckatyn', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006783']
211,32332590,Effect of cognitive-behavioral therapy with music therapy in reducing physics test anxiety among students as measured by generalized test anxiety scale.,"BACKGROUND


The study determined the effect of cognitive-behavioral therapy (CBT) with music in reducing physics test anxiety among secondary school students as measured by generalized test anxiety scale.
METHODS


Pre-test post-test randomized control trial experimental design was adopted in this study. A total of 83 senior secondary students including male (n = 46) and female (n = 37) from sampled secondary schools in Enugu State, Nigeria, who met the inclusion criteria constituted participants for the study. A demographic questionnaire and a 48-item generalized test anxiety scale were used for data collection for the study. Subjects were randomized into treatment and control groups. The treatment group was exposed to a 12-week CBT-music program. Thereafter, the participants in the treatment group were evaluated at 3 time points. Data collected were analyzed using repeated measures analysis of variance.
RESULTS


The participants who were exposed to CBT-music intervention program significantly had lower test anxiety scores at the post-treatment than the participants in the control group. Furthermore, the test anxiety scores of the participants in the CBT-music group were significantly lower than those in the control group at the follow-up measure. Thus, the results showed a significant effect of CBT with music in reducing physics test anxiety among secondary school students.
CONCLUSION


We concluded that CBT-music program has a significant benefit in improving the management of physics test anxiety among secondary school students.",2020,"Furthermore, the test anxiety scores of the participants in the CBT-music group were significantly lower than those in the control group at the follow-up measure.","['83 senior secondary students including male (n\u200a=\u200a46) and female (n\u200a=\u200a37) from sampled secondary schools in Enugu State, Nigeria, who met the inclusion criteria constituted participants for the study', 'secondary school students']","['CBT-music intervention program', 'CBT-music program', 'cognitive-behavioral therapy with music therapy', 'CBT', 'cognitive-behavioral therapy (CBT']","['generalized test anxiety scale', 'test anxiety scores', 'physics test anxiety']","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0039577', 'cui_str': 'Test Anxiety Questionnaire'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031837', 'cui_str': 'Physics'}]",83.0,0.0210617,"Furthermore, the test anxiety scores of the participants in the CBT-music group were significantly lower than those in the control group at the follow-up measure.","[{'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Ugwuanyi', 'Affiliation': 'Postdoctoral fellow, School of Education Studies, Faculty of Education, University of the Free State, Bloemfontein, South Africa.'}, {'ForeName': 'Moses O', 'Initials': 'MO', 'LastName': 'Ede', 'Affiliation': 'Department of Educational Foundations.'}, {'ForeName': 'Charity N', 'Initials': 'CN', 'LastName': 'Onyishi', 'Affiliation': ''}, {'ForeName': 'Osita V', 'Initials': 'OV', 'LastName': 'Ossai', 'Affiliation': ''}, {'ForeName': 'Edith N', 'Initials': 'EN', 'LastName': 'Nwokenna', 'Affiliation': 'Department of Art Education, Faculty of Education, University of Nigeria, Nsukka.'}, {'ForeName': 'Lauretta C', 'Initials': 'LC', 'LastName': 'Obikwelu', 'Affiliation': 'Department of Educational Foundations.'}, {'ForeName': 'Amaka', 'Initials': 'A', 'LastName': 'Ikechukwu-Ilomuanya', 'Affiliation': ''}, {'ForeName': 'Chijioke V', 'Initials': 'CV', 'LastName': 'Amoke', 'Affiliation': 'Department of Educational Foundations.'}, {'ForeName': 'Agnes O', 'Initials': 'AO', 'LastName': 'Okeke', 'Affiliation': 'Postdoctoral fellow, School of Education Studies, Faculty of Education, University of the Free State, Bloemfontein, South Africa.'}, {'ForeName': 'Catherine U', 'Initials': 'CU', 'LastName': 'Ene', 'Affiliation': 'Postdoctoral fellow, School of Education Studies, Faculty of Education, University of the Free State, Bloemfontein, South Africa.'}, {'ForeName': 'Edmund E', 'Initials': 'EE', 'LastName': 'Offordile', 'Affiliation': 'Department of Educational Foundations.'}, {'ForeName': 'Lilian C', 'Initials': 'LC', 'LastName': 'Ozoemena', 'Affiliation': 'Department of Educational Foundations.'}, {'ForeName': 'Maduka L', 'Initials': 'ML', 'LastName': 'Nweke', 'Affiliation': 'Department of Physiology, Faculty of Basic Medical Sciences, College of Medicine, University of Nigeria, Ituku-Ozalla, Enugu State, Nigeria.'}]",Medicine,['10.1097/MD.0000000000016406']
212,32234313,Does misperception of fruit and vegetable intake adequacy affect progression through the stages of behavior change after nutritional intervention?,"Pseudomaintenance (PM) is a Transtheoretical Model (TTM) stage of change that refers to individuals who believe they eat enough fruit and vegetables (FV) despite their low FV intake. It is not known how they change behavior after usual TTM-based interventions. Thus, this randomized controlled community trial describes the effect of PM on progression through the stages of change for FV intake among adult and elderly health promotion service users after TTM-based intervention. The stage of change for FV intake was assessed; FV intake was estimated from brief validated questions at baseline (n = 3414) and follow-up (n = 1782). Individuals whose perception of adequacy matched the estimated intake were labeled as ""concordant perception,"" while those with low intake who believed that their intake was adequate were classified as being in PM. The intervention group received the intervention while the control group received usual care. The prevalence of ""no stage progression"" at follow-up was close to 50% for those in PM at baseline. After adjustment for demographics, randomization, self-efficacy, decisional balance, and baseline intake, users in PM at baseline had higher odds [OR = 1.53 (1.21-1.94)] of progressing to higher stages for fruit and no difference in progression for vegetables. We propose strategies to approach FV intake in future studies and reinforce the need for additional trials aimed at describing changes in FV intake among individuals in PM, in order to continue answering the scientific questions that we began to investigate.",2020,"The prevalence of ""no stage progression"" at follow-up was close to 50% for those in PM at baseline.",['adult and elderly health promotion service users after TTM-based intervention'],"['Pseudomaintenance (PM', 'intervention while the control group received usual care', 'PM']","['self-efficacy, decisional balance, and baseline intake, users in PM', 'prevalence of ""no stage progression', 'FV intake']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0040953', 'cui_str': 'Trichotillomania'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",,0.0477207,"The prevalence of ""no stage progression"" at follow-up was close to 50% for those in PM at baseline.","[{'ForeName': 'Maria Cecília Ramos de', 'Initials': 'MCR', 'LastName': 'Carvalho', 'Affiliation': 'Universidade Federal de Minas Gerais, Grupo de Pesquisa de Intervenções em Nutrição, 190 Alfredo Balena Avenue, Nursing School, Room 316, Santa Efigênia, 30130-100, Belo Horizonte, MG, Brazil. Electronic address: ceciliaramosnutri@gmail.com.'}, {'ForeName': 'Mariana Carvalho de', 'Initials': 'MC', 'LastName': 'Menezes', 'Affiliation': 'Universidade Federal de Ouro Preto, Escola de Nutrição, Departamento de Nutrição Clínica e Social, Programa de Pós-Graduação em Saúde e Nutrição, Grupo de Pesquisa de Intervenções em Nutrição, Dois Street, Morro do Cruzeiro Campus, Nutrition School, Room 65, 35400-000, Ouro Preto, MG, Brazil. Electronic address: marysnut@gmail.com.'}, {'ForeName': 'Natacha', 'Initials': 'N', 'LastName': 'Toral', 'Affiliation': 'Universidade de Brasilia, Faculdade de Ciências da Saúde, Departamento de Nutrição, Programa de Pós-Graduação em Nutrição Humana, Darcy Ribeiro Campus, Health Sciences School, 70910-900, Brasília (North Wing), DF, Brazil. Electronic address: natachatoral@hotmail.com.'}, {'ForeName': 'Aline Cristine Souza', 'Initials': 'ACS', 'LastName': 'Lopes', 'Affiliation': 'Universidade Federal de Minas Gerais, Escola de Enfermagem, Departamento de Nutrição, Programa de Pós-Graduação em Nutrição e Saúde, Grupo de Pesquisa de Intervenções em Nutrição, 190 Alfredo Balena Avenue, Nursing School, Room 316, Santa Efigênia, 30130-100, Belo Horizonte, MG, Brazil. Electronic address: alinelopesenf@gmail.com.'}]",Appetite,['10.1016/j.appet.2020.104682']
213,32244170,Endogenous in-session cortisol during exposure therapy predicts symptom improvement: Preliminary results from a scopolamine-augmentation trial.,"The purpose of this study was to explore whether individual differences in glucocorticoid concentrations were associated with symptom improvement following exposure therapy for patients with social anxiety disorder. To do this, 60 participants with social anxiety disorder completed a randomized-controlled trial of exposure therapy, where participants were randomized to receive scopolamine-augmentation or placebo during their 7 exposure sessions. Scopolamine is an antimuscarinic which blocks the effects of acetylcholine and reduces autonomic arousal. During sessions 1, 4, 7, and during the post-treatment extinction assessment, participants provided up to 16 saliva samples (4 in each session). Pre-treatment, post-treatment, and at 1-month follow-up, participants completed the Liebowitz Social Anxiety Scale to monitor change in fear and avoidance symptoms. Elevated endogenous in-session cortisol during exposure sessions was associated with less symptom improvement from pre- to post-treatment and at 1-month follow-up. The association between elevated endogenous in-session cortisol and attenuated symptom change was not moderated by scopolamine treatment condition. Individuals with social anxiety disorder who have elevated neuroendocrine signaling may under-benefit from exposure therapy. This is the first study, to our knowledge, to examine whether endogenous in-session cortisol concentrations predict symptom changes following exposure therapy for the treatment of social anxiety disorder. More investigation of non-invasive and reliable biological markers that explain variability in responses to effective treatments are needed.",2020,Elevated endogenous in-session cortisol during exposure sessions was associated with less symptom improvement from pre- to post-treatment and at 1-month follow-up.,"['patients with social anxiety disorder', 'social anxiety disorder', '60 participants with social anxiety disorder', 'Individuals with social anxiety disorder who have elevated neuroendocrine signaling may under-benefit from exposure therapy']","['acetylcholine', 'Scopolamine', 'scopolamine', 'scopolamine-augmentation or placebo', 'exposure therapy']","['Liebowitz Social Anxiety Scale to monitor change in fear and avoidance symptoms', 'symptom improvement', 'autonomic arousal']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0027912', 'cui_str': 'Neuroendocrine System'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]","[{'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0036442', 'cui_str': 'Scopolamine'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]","[{'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}]",60.0,0.01704,Elevated endogenous in-session cortisol during exposure sessions was associated with less symptom improvement from pre- to post-treatment and at 1-month follow-up.,"[{'ForeName': 'Kate R', 'Initials': 'KR', 'LastName': 'Kuhlman', 'Affiliation': 'Department of Psychological Science, University of California Irvine, Irvine, CA, 92697, United States; Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, 90095, United States; Institute for Interdisciplinary Salivary Bioscience, University of California Irvine, Irvine, CA, 92697, United States. Electronic address: krkuhl@uci.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Treanor', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, 90095, United States.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Imbriano', 'Affiliation': 'Department of Psychology, Stony Brook University, Stony Brook, NY, 11794, United States.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Craske', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, 90095, United States; Department of Psychology, University of California Los Angeles, Los Angeles, CA, 90095, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104657']
214,32246953,Teaching people to eat according to appetite - Does the method of glucose measurement matter?,"BACKGROUND


Hunger training teaches people to eat according to their appetite using pre-prandial glucose measurement. Previous hunger training interventions used fingerprick blood glucose, however continuous glucose monitoring (CGM) offers a painless and convenient form of glucose monitoring. The aim of this randomised feasibility trial was to compare hunger training using CGM with fingerprick glucose monitoring in terms of adherence to the protocol, acceptability, weight, body composition, HbA1c, psychosocial variables, and the relationship between adherence measures and weight loss.
METHODS


40 adults with obesity were randomised to either fingerpricking or scanning with a CGM and followed identical interventions for 6 months, which included 1 month of only eating when glucose was under their individualised glucose cut-off. For months 2-6 participants relied on their sensations of hunger to guide their eating and filled in a booklet.
RESULTS


90% of the fingerpricking group and 85% of the scanning group completed the study. Those using the scanner measured their glucose an extra 1.9 times per day (95% CI 0.9, 2.8, p < 0.001) compared with those testing by fingerprick. Both groups lost similar amounts of weight over 6 months (on average 4 kg), were satisfied with the hunger training program and wanted to measure their glucose again within the next year. There were no differences between groups in terms of intervention acceptability, weight, body composition, HbA1c, eating behaviours, or psychological health. Frequency of glucose testing and booklet entry both predicted a clinically meaningful amount of weight loss.
CONCLUSIONS


Either method of measuring glucose is effective for learning to eat according to hunger using the hunger training program. As scanning with a CGM encouraged better adherence to the protocol without sacrificing outcome results, future interventions should consider using this new technology in hunger training programs.",2020,"There were no differences between groups in terms of intervention acceptability, weight, body composition, HbA1c, eating behaviours, or psychological health.",['40 adults with obesity'],"['continuous glucose monitoring (CGM', 'hunger training using CGM with fingerprick glucose monitoring', 'fingerpricking or scanning with a CGM and followed identical interventions for 6 months, which included 1 month of only eating when glucose was under their individualised glucose cut-off']","['intervention acceptability, weight, body composition, HbA1c, eating behaviours, or psychological health', 'adherence to the protocol, acceptability, weight, body composition, HbA1c, psychosocial variables']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0202048', 'cui_str': 'Glucose measurement by monitoring device'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C1518543', 'cui_str': 'Off'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}]",40.0,0.0289517,"There were no differences between groups in terms of intervention acceptability, weight, body composition, HbA1c, eating behaviours, or psychological health.","[{'ForeName': 'Michelle R', 'Initials': 'MR', 'LastName': 'Jospe', 'Affiliation': 'Department of Medicine, University of Otago, PO Box 56, Dunedin, 9054, New Zealand. Electronic address: michelle.jospe@otago.ac.nz.'}, {'ForeName': 'Willemijn E', 'Initials': 'WE', 'LastName': 'de Bruin', 'Affiliation': 'Department of Medicine, University of Otago, PO Box 56, Dunedin, 9054, New Zealand. Electronic address: w.debruin@otago.ac.nz.'}, {'ForeName': 'Jillian J', 'Initials': 'JJ', 'LastName': 'Haszard', 'Affiliation': 'Centre for Biostatistics, University of Otago, PO Box 56, Dunedin, 9054, New Zealand. Electronic address: jill.haszard@otago.ac.nz.'}, {'ForeName': 'Jim I', 'Initials': 'JI', 'LastName': 'Mann', 'Affiliation': 'Department of Medicine, University of Otago, PO Box 56, Dunedin, 9054, New Zealand. Electronic address: jim.mann@otago.ac.nz.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Brunton', 'Affiliation': 'Information Technology Services, University of Otago, PO Box 56, Dunedin, 9054, New Zealand. Electronic address: mark.brunton@otago.ac.nz.'}, {'ForeName': 'Rachael W', 'Initials': 'RW', 'LastName': 'Taylor', 'Affiliation': 'Department of Medicine, University of Otago, PO Box 56, Dunedin, 9054, New Zealand. Electronic address: rachael.taylor@otago.ac.nz.'}]",Appetite,['10.1016/j.appet.2020.104691']
215,32338190,Splinting versus extension-block pinning of bony mallet finger: a randomized clinical trial.,"Surgical treatment of bony mallet fingers is frequently recommended, but the evidence is sparse. This randomized clinical trial aimed to compare nonoperative splinting versus extension-block pinning of bony mallet fingers with involvement of more than one-third of the joint surface but without primary joint subluxation. Thirty-two patients were randomized and 28 fulfilled the protocol. At 6 months follow-up, there were no significant differences in active extension lag in the distal interphalangeal joint (the primary outcome) or in patient-reported function and pain scores. Flexion and active range of motion in the distal interphalangeal joint and finger-to-palm distance were better in the splinting group, but three patients developed secondary subluxation. We conclude from this study, that splinting these injuries is safe and efficient in restoring joint motion, but splinting does not sufficiently prevent secondary subluxation of the joint. Radiographic follow-up during splinting appears to be necessary.  Level of evidence:  I.",2020,"Flexion and active range of motion in the distal interphalangeal joint and finger-to-palm distance were better in the splinting group, but three patients developed secondary subluxation.",['Thirty-two patients were randomized and 28 fulfilled the protocol'],"['nonoperative splinting versus extension-block', 'Splinting versus extension-block pinning of bony mallet finger']","['active extension lag in the distal interphalangeal joint', 'function and pain scores', 'Flexion and active range of motion in the distal interphalangeal joint and finger-to-palm distance']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0204861', 'cui_str': 'Application of splint'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0443157', 'cui_str': 'Bony'}, {'cui': 'C0158473', 'cui_str': 'Mallet finger'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0231746', 'cui_str': 'Extension lag finding'}, {'cui': 'C0932510', 'cui_str': 'Structure of distal interphalangeal joint'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0230373', 'cui_str': 'Palm of hand (surface region)'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",32.0,0.112533,"Flexion and active range of motion in the distal interphalangeal joint and finger-to-palm distance were better in the splinting group, but three patients developed secondary subluxation.","[{'ForeName': 'Janni K', 'Initials': 'JK', 'LastName': 'Thillemann', 'Affiliation': 'Department of Orthopaedics, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Theis M', 'Initials': 'TM', 'LastName': 'Thillemann', 'Affiliation': 'Department of Orthopaedics, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Pia K', 'Initials': 'PK', 'LastName': 'Kristensen', 'Affiliation': 'Department of Orthopaedic Surgery, Regional Hospital Horsens, Horsens, Denmark.'}, {'ForeName': 'Anders D', 'Initials': 'AD', 'LastName': 'Foldager-Jensen', 'Affiliation': 'Department of Orthopaedics, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Munk', 'Affiliation': 'Department of Orthopaedics, Aarhus University Hospital, Aarhus, Denmark.'}]","The Journal of hand surgery, European volume",['10.1177/1753193420917567']
216,24615411,How can communication by oncologists enhance patients' trust? An experimental study.,"BACKGROUND


Cancer patients need to trust their oncologist to embark in the process of oncologic treatment. Yet, it is unclear how oncologist communication contributes to such trust. The aim of this study was to investigate the effect of three elements of oncologists' communication on cancer patients' trust: conferring competence, honesty, and caring.
METHODS


Eight videotaped consultations, 'vignettes', were created, reflecting an encounter between an oncologist and a patient with colorectal cancer. All vignettes were identical, except for small variations in the oncologist's verbal communication. Cancer patients (n = 345) were randomly assigned to viewing two vignettes, asked to identify with the patient and afterwards to rate their trust in the observed oncologist. The effects of competence, honesty, and caring on trust were established with multilevel analysis.
RESULTS


Oncologist's enhanced expression of competence (β = 0.17, 95% CI 0.08, 0.27; P < 0.001), honesty (β = 0.30, 95% CI 0.20, 0.40; P < 0.001), as well as caring (β = 0.36, 95% CI 0.26, 0.46; P < 0.001) resulted in significantly increased trust. Communication of honesty and caring also increased patients' expectation of operation success and reported willingness to recommend the oncologist.
CONCLUSION(S)


As hypothesized, oncologists can influence their patients' trust by enhanced conveyance of their level of competence, honesty, and caring. Caring behavior has the strongest impact on trust. These findings can be translated directly into daily clinical practice as well as in communication skills training.",2014,"Communication of honesty and caring also increased patients' expectation of operation success and reported willingness to recommend the oncologist.
","['Cancer patients (n = 345', 'Cancer patients', ""Eight videotaped consultations, 'vignettes', were created, reflecting an encounter between an oncologist and a patient with colorectal cancer""]",[],"['expression of competence', 'trust']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}]",[],"[{'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0237935', 'cui_str': 'Trust'}]",345.0,0.0571336,"Communication of honesty and caring also increased patients' expectation of operation success and reported willingness to recommend the oncologist.
","[{'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Hillen', 'Affiliation': 'Departments of Medical Psychology. Electronic address: m.a.hillen@amc.uva.nl.'}, {'ForeName': 'H C J M', 'Initials': 'HCJM', 'LastName': 'de Haes', 'Affiliation': 'Departments of Medical Psychology.'}, {'ForeName': 'L J A', 'Initials': 'LJA', 'LastName': 'Stalpers', 'Affiliation': 'Radiotherapy.'}, {'ForeName': 'J H G', 'Initials': 'JHG', 'LastName': 'Klinkenbijl', 'Affiliation': 'Surgery, Academic Medical Center, University of Amsterdam, Amsterdam.'}, {'ForeName': 'E H', 'Initials': 'EH', 'LastName': 'Eddes', 'Affiliation': 'Department of Surgery, Deventer Hospital, Deventer, The Netherlands.'}, {'ForeName': 'P N', 'Initials': 'PN', 'LastName': 'Butow', 'Affiliation': 'Centre for Medical Psychology and Evidence-based Decision-making (CeMPED) - School of Psychology, University of Sydney, Sydney, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van der Vloodt', 'Affiliation': 'Departments of Medical Psychology.'}, {'ForeName': 'H W M', 'Initials': 'HWM', 'LastName': 'van Laarhoven', 'Affiliation': 'Department of Medical Oncology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'E M A', 'Initials': 'EMA', 'LastName': 'Smets', 'Affiliation': 'Departments of Medical Psychology.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu027']
217,24615500,Incidence and time course of everolimus-related adverse events in postmenopausal women with hormone receptor-positive advanced breast cancer: insights from BOLERO-2.,"BACKGROUND


In the BOLERO-2 trial, everolimus (EVE), an inhibitor of mammalian target of rapamycin, demonstrated significant clinical benefit with an acceptable safety profile when administered with exemestane (EXE) in postmenopausal women with hormone receptor-positive (HR(+)) advanced breast cancer. We report on the incidence, time course, severity, and resolution of treatment-emergent adverse events (AEs) as well as incidence of dose modifications during the extended follow-up of this study.
PATIENTS AND METHODS


Patients were randomized (2:1) to receive EVE 10 mg/day or placebo (PBO), with open-label EXE 25 mg/day (n = 724). The primary end point was progression-free survival. Secondary end points included overall survival, objective response rate, and safety. Safety evaluations included recording of AEs, laboratory values, dose interruptions/adjustments, and study drug discontinuations.
RESULTS


The safety population comprised 720 patients (EVE + EXE, 482; PBO + EXE, 238). The median follow-up was 18 months. Class-effect toxicities, including stomatitis, pneumonitis, and hyperglycemia, were generally of mild or moderate severity and occurred relatively early after treatment initiation (except pneumonitis); incidence tapered off thereafter. EVE dose reduction and interruption (360 and 705 events, respectively) required for AE management were independent of patient age. The median duration of dose interruption was 7 days. Discontinuation of both study drugs because of AEs was higher with EVE + EXE (9%) versus PBO + EXE (3%).
CONCLUSIONS


Most EVE-associated AEs occur soon after initiation of therapy, are typically of mild or moderate severity, and are generally manageable with dose reduction and interruption. Discontinuation due to toxicity was uncommon. Understanding the time course of class-effect AEs will help inform preventive and monitoring strategies as well as patient education.
TRIAL REGISTRATION NUMBER


NCT00863655.",2014,"EVE dose reduction and interruption (360 and 705 events, respectively) required for AE management were independent of patient age.","['postmenopausal women with hormone receptor-positive (HR(+)) advanced breast cancer', '720 patients (EVE + EXE, 482; PBO + EXE, 238', 'Patients', 'postmenopausal women with hormone receptor-positive advanced breast cancer']","['EVE + EXE', 'exemestane (EXE', 'everolimus (EVE', 'EVE 10 mg/day or placebo (PBO), with open-label EXE']","['Class-effect toxicities, including stomatitis, pneumonitis, and hyperglycemia', 'incidence, time course, severity, and resolution of treatment-emergent adverse events (AEs', 'overall survival, objective response rate, and safety', 'progression-free survival', 'recording of AEs, laboratory values, dose interruptions/adjustments, and study drug discontinuations', 'median duration of dose interruption']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C4517865', 'cui_str': 'Seven hundred and twenty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0047006', 'cui_str': '(R,S)-N-ethyl-3,4-methylenedioxyamphetamine'}]","[{'cui': 'C0047006', 'cui_str': '(R,S)-N-ethyl-3,4-methylenedioxyamphetamine'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C3714636', 'cui_str': 'Pulmonary Inflammation'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0449247', 'cui_str': 'Time course (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",724.0,0.267679,"EVE dose reduction and interruption (360 and 705 events, respectively) required for AE management were independent of patient age.","[{'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'University of California, San Francisco Helen Diller Family Comprehensive Cancer Center, UCSF, San Francisco, USA. Electronic address: hrugo@medicine.ucsf.edu.'}, {'ForeName': 'K I', 'Initials': 'KI', 'LastName': 'Pritchard', 'Affiliation': 'Sunnybrook Odette Cancer Centre and the University of Toronto, Toronto, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gnant', 'Affiliation': 'Department of Surgery, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Noguchi', 'Affiliation': 'Department of Breast and Endocrine Surgery, Osaka University, Osaka, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Piccart', 'Affiliation': 'Institut Jules Bordet, Brussels, Belgium.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Hortobagyi', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Baselga', 'Affiliation': 'Memorial Sloan-Kettering Cancer Center, New York.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Perez', 'Affiliation': 'Memorial Cancer Institute, Hollywood, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Geberth', 'Affiliation': 'Praxisklinic am Rosengarten Mannheim, Schwerpunktpraxis für Gynaekologische Onkologie, Mannheim, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Csoszi', 'Affiliation': 'Department of Medical Oncology, Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Szolnok, Hungary.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Chouinard', 'Affiliation': 'Cambridge Memorial Hospital, Cambridge, Canada.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Srimuninnimit', 'Affiliation': 'Siriraj Hospital, Mahidol University, Bangkok.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Puttawibul', 'Affiliation': 'Songklanagarind Hospital, Faculty of Medicine, Prince of Songkla University, Songkla, Thailand.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Eakle', 'Affiliation': 'Florida Cancer Specialists, Ft Myers.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Feng', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Bauly', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'El-Hashimy', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Taran', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, USA.'}, {'ForeName': 'H A', 'Initials': 'HA', 'LastName': 'Burris', 'Affiliation': 'Sarah Cannon Research Institute, Nashville, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu009']
218,24667715,A randomized controlled phase II trial of a novel composition of paclitaxel embedded into neutral and cationic lipids targeting tumor endothelial cells in advanced triple-negative breast cancer (TNBC).,"BACKGROUND


EndoTAG-1, composed of paclitaxel embedded in liposomal membranes targeting tumor endothelial cells, was evaluated for safety and efficacy in advanced triple-negative breast cancer (TNBC).
PATIENTS AND METHODS


One hundred and forty patients were treated with weekly EndoTAG-1 (22 mg/m(2)) plus paclitaxel (70 mg/m(2)), twice weekly EndoTAG-1 (2× 44 mg/m(2)), or weekly paclitaxel (90 mg/m(2)) for greater than or equal to four cycles (3-week treatment + 1-week rest) or until progression/toxicity. Primary end point was progression-free survival (PFS) rate evaluated centrally after four cycles of therapy (week 16). The study was not powered for intergroup comparisons.
RESULTS


The PFS rate at week 16 was 59.1% [one-sided 95% CI: 45.6, ∞] on combination treatment, 34.2% [21.6, ∞] on EndoTAG-1, and 48.0% [30.5, ∞] on paclitaxel. Median PFS reached 4.2, 3.4, and 3.7 months, respectively. After complete treatment (week 41 analysis), median overall survival (OS) was 13.0, 11.9, and 13.1 months for the modified Intention-to-Treat (ITT) population and 15.1, 12.5, and 8.9 months for the per-protocol population, respectively. The clinical benefit rate was 53%, 31%, and 36% for the treatment groups. Safety analysis revealed known toxicities of the drugs with slight increases of grade 3/4 neutropenia on combination therapy.
CONCLUSION


Treatment of advanced TNBC with a combination of EndoTAG-1 and standard paclitaxel [Taxol® (Bristol-Myers Squibb GmbH), or equivalent generic formulation] was well tolerated and showed antitumor efficacy. The positive trend needs to be confirmed in a randomized phase III trial.
STUDY REGISTRATION


European Clinical Trials Database: EudraCT number 2006-002221-23. ClinicalTrials.gov identifier: NCT00448305.",2014,"The PFS rate at week 16 was 59.1% [one-sided 95% CI: 45.6, ∞] on combination treatment, 34.2% [21.6, ∞] on EndoTAG-1, and 48.0% [30.5, ∞] on paclitaxel.","['One hundred and forty patients', 'advanced triple-negative breast cancer (TNBC']","['paclitaxel', 'paclitaxel (90 mg/m(2)) for greater than or equal to four cycles (3-week treatment + 1-week rest) or until progression/toxicity', 'EndoTAG-1', 'paclitaxel embedded into neutral and cationic lipids targeting tumor endothelial cells', 'EndoTAG-1 and standard paclitaxel [Taxol®']","['PFS rate', 'tolerated and showed antitumor efficacy', 'clinical benefit rate', 'Median PFS', 'safety and efficacy', 'grade 3/4 neutropenia', 'median overall survival (OS', 'progression-free survival (PFS) rate']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C3539878', 'cui_str': 'Triple Negative Breast Cancer'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0225336', 'cui_str': 'Endothelial Cells'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0678133', 'cui_str': 'Taxol'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",140.0,0.0874955,"The PFS rate at week 16 was 59.1% [one-sided 95% CI: 45.6, ∞] on combination treatment, 34.2% [21.6, ∞] on EndoTAG-1, and 48.0% [30.5, ∞] on paclitaxel.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Awada', 'Affiliation': 'Institut Jules Bordet, Université Libre de Bruxelles, Bruxelles, Belgium. Electronic address: ahmad.awada@bordet.be.'}, {'ForeName': 'I N', 'Initials': 'IN', 'LastName': 'Bondarenko', 'Affiliation': 'Dnepropetrovsk State Medical Academy, Dnepropetrovsk, Ukraine.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bonneterre', 'Affiliation': 'Oscar Lambret Center of Fight Against Cancer, Lille, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Nowara', 'Affiliation': 'Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice, Poland.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Ferrero', 'Affiliation': 'Antoine Lacassagne Center of Fight Against Cancer, Nice, France.'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Bakshi', 'Affiliation': 'Kaushalya Medical Foundation, Thane, India.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Wilke', 'Affiliation': 'Medigene AG, Martinsried, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Piccart', 'Affiliation': 'Institut Jules Bordet, Université Libre de Bruxelles, Bruxelles, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu025']
219,24667714,"High concordance of protein (by IHC), gene (by FISH; HER2 only), and microarray readout (by TargetPrint) of ER, PgR, and HER2: results from the EORTC 10041/BIG 03-04 MINDACT trial.","BACKGROUND


To investigate the correlation of TargetPrint with local and central immunohistochemistry/fluorescence in situ hybridization assessment of estrogen (ER), progesterone (PgR), and human epidermal growth factor receptor 2 (HER2) in the first 800 patients enrolled in the MINDACT trial.
PATIENTS AND METHODS


Data from local (N = 800) and central (N = 626) assessments of receptor status were collected and compared with TargetPrint results.
RESULTS


For ER, the positive agreement (the percentage of central pathology positive assessments that were also TargetPrint/local laboratory positive) for TargetPrint in comparison to centralized assessment was 98% with a negative agreement (the percentage of central pathology negative assessments that were also TargetPrint/local laboratory negative) of 96%. For PgR, the positive agreement was 83% with a negative agreement of 92%. For HER2, the positive agreement was 75% with a negative agreement of 99%. Even though the local assessment showed higher positive agreement for PgR (89%) and higher positive agreement for HER2 (85%), the range of discordant local versus central assessments were as high as 6.7% for ER, 12.9% for PgR, and 4.3% for HER2.
CONCLUSION


TargetPrint and local assessment of ER, PgR, and HER2 show high concordance with central assessment in the first 800 MINDACT patients. However, there are concerns about the higher discordance rates for some local sites. TargetPrint can improve the reliability of hormone receptor and HER2 testing for those centers with a lower rate of concordance with the reference laboratory, with the limitation of a positive agreement of 75% for HER2. TargetPrint consequently has important implications for treatment decisions in clinical practice and is a reliable alternative to local assessment for ER.
CLINICAL TRIALS NUMBER


NCT00433589.",2014,"Even though the local assessment showed higher positive agreement for PgR (89%) and higher positive agreement for HER2 (85%), the range of discordant local versus central assessments were as high as 6.7% for ER, 12.9% for PgR, and 4.3% for HER2.
","['Data from local (N = 800) and central (N = 626', '800 patients enrolled in the MINDACT trial']",['EORTC'],['reliability of hormone receptor and HER2 testing'],"[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}]",800.0,0.0611438,"Even though the local assessment showed higher positive agreement for PgR (89%) and higher positive agreement for HER2 (85%), the range of discordant local versus central assessments were as high as 6.7% for ER, 12.9% for PgR, and 4.3% for HER2.
","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Viale', 'Affiliation': 'Department of Pathology, European Institute of Oncology and University of Milan, Milan, Italy. Electronic address: giuseppe.viale@ieo.it.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Slaets', 'Affiliation': 'Department of Statistics, European Organization for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bogaerts', 'Affiliation': 'Department of Statistics, European Organization for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Rutgers', 'Affiliation': 'Department of Surgery, Netherlands Cancer Institute, Amsterdam.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': ""Van't Veer"", 'Affiliation': 'Department of Pathology, Netherlands Cancer Institute, Amsterdam, The Netherlands; Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA, USA; Research and Development, Agendia, Amsterdam, The Netherlands.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Piccart-Gebhart', 'Affiliation': 'Department of Medical Oncology, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'F A', 'Initials': 'FA', 'LastName': 'de Snoo', 'Affiliation': 'Medical Affairs, Agendia, Amsterdam, The Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Stork-Sloots', 'Affiliation': 'Medical Affairs, Agendia, Amsterdam, The Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Russo', 'Affiliation': 'Department of Pathology, European Institute of Oncology and University of Milan, Milan, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': ""Dell'Orto"", 'Affiliation': 'Department of Pathology, European Institute of Oncology and University of Milan, Milan, Italy.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van den Akker', 'Affiliation': 'Research and Development, Agendia, Amsterdam, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Glas', 'Affiliation': 'Research and Development, Agendia, Amsterdam, The Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Cardoso', 'Affiliation': 'Breast Unit, Champalimaud Cancer Center, Lisbon, Portugal.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu026']
220,32338459,Bioequivalence and pharmacodynamics of a generic dabigatran etexilate capsule in healthy Chinese subjects under fasting and fed conditions.,"To assess bioequivalence of a generic dabigatran etexilate capsule in healthy Chinese subjects under fasting and fed conditions. This was an open-label, single-center, randomized four-period crossover study with a 7-day washout period. A single oral dose of 150 mg generic dabigatran etexilate capsule (test drug) or a commercial dabigatran etexilate capsule (Pradaxa ®  , reference drug) was given to healthy volunteers under the fasting and fed conditions. Plasma concentrations of total and free dabigatran were detected using a validated HPLC-MS/MS method. A noncompartmental method was used for pharmacokinetic analysis and established coagulation assays were applied for pharmacodynamic analysis. The 90% CIs of the test/reference ratios of C max  , AUC 0-t  , and AUC 0-∞  for the total dabigatran concentration were 92.57%-106.58%, 91.63%-106.32%, and 92.54%-106.17%, respectively, under fasting condition, and 99.30%-110.74%, 98.58%-105.37%, and 97.75%-103.99%, respectively, under fed conditions. The 90% CIs of the ratios of the parameters for the free dabigatran were 93.18%-106.98%, 92.13%-107.10%, 92.89%-106.48%, respectively, under fasting condition, and 100.05%-110.89%, 99.37%-106.23%, 97.59%-103.98%, respectively, under the fed condition. Additionally, the upper limit of the 90% CIs for σWT/σWR was below 2.5. There were no significant differences in the coagulation parameters including thrombin clotting time, activated partial thromboplastin time, and anti-IIa activity between the two preparations. The generic dabigatran etexilate capsule is bioequivalent to the brand-named product in healthy Chinese volunteers under fasting and fed conditions. The two products have comparable pharmacodynamic parameters, with a good safety profile. In addition, food intake influences absorption of both products in a similar way.",2020,"There were no significant differences in the coagulation parameters including thrombin clotting time, activated partial thromboplastin time, and anti-IIa activity between the two preparations.","['healthy volunteers under the fasting and fed conditions', 'healthy Chinese volunteers under fasting and fed conditions', 'healthy Chinese subjects under fasting and fed conditions']","['generic dabigatran etexilate capsule', '150\xa0mg generic dabigatran etexilate capsule (test drug) or a commercial dabigatran etexilate capsule (Pradaxa ®  , reference drug']","['Plasma concentrations of total and free dabigatran', 'reference ratios of C max  , AUC 0-t  , and AUC 0-∞  for the total dabigatran concentration', 'coagulation parameters including thrombin clotting time, activated partial thromboplastin time, and anti-IIa activity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0342895', 'cui_str': 'Fish-eye disease'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]","[{'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C2940577', 'cui_str': 'dabigatran etexilate Oral Capsule'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0038577', 'cui_str': 'Drug of abuse screen'}, {'cui': 'C2940579', 'cui_str': 'Pradaxa'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0677634', 'cui_str': 'Reptilase time'}, {'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.0534543,"There were no significant differences in the coagulation parameters including thrombin clotting time, activated partial thromboplastin time, and anti-IIa activity between the two preparations.","[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Pharmacy, The Third Hospital of Changsha, Changsha, The People's Republic of China.""}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Pharmacy, The Third Hospital of Changsha, Changsha, The People's Republic of China.""}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': ""Department of Pharmacy, The Third Hospital of Changsha, Changsha, The People's Republic of China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Xiang', 'Affiliation': ""Department of Pharmacy, Peking University First Hospital, Beijing, The People's Republic of China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Pharmacy, The Third Hospital of Changsha, Changsha, The People's Republic of China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': ""Department of Pharmacy, The Third Hospital of Changsha, Changsha, The People's Republic of China.""}, {'ForeName': 'Yangyang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Pharmacy, The Third Hospital of Changsha, Changsha, The People's Republic of China.""}, {'ForeName': 'Qiufen', 'Initials': 'Q', 'LastName': 'Xie', 'Affiliation': ""Department of Pharmacy, Peking University First Hospital, Beijing, The People's Republic of China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Mao', 'Affiliation': ""Chengdu Brilliant Pharmaceutical Co. Ltd, Chengdu, The People's Republic of China.""}, {'ForeName': 'Yimin', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': ""Department of Pharmacy, Peking University First Hospital, Beijing, The People's Republic of China.""}]",Pharmacology research & perspectives,['10.1002/prp2.593']
221,32332591,Effects of group cognitive-behavioral therapy on psychological distress of awaiting-trial prison inmates.,"BACKGROUND/OBJECTIVES


The level of psychological distress among awaiting-trial inmates is rapidly increasing in Nigeria. Studies have recommended increasing attention and additional psychological intervention that could improve the psychological wellbeing of prisoners. This study evaluates the effect of cognitive behavioral therapy on psychological distress among awaiting-trial prison inmates in Nigeria.
METHODS


A total of 34 awaiting-trial prison inmates in Enugu state Nigeria were used as the study participants. Two measures (perceived emotional distress inventory and general health Questionnaire) were used for data collection. Repeated measures with analysis of variance (ANOVA) were used to examine the effects of the intervention. Effect sizes were also reported with partial Eta Squared ((Equation is included in full-text article.)).
RESULTS


The result showed that there was no significant difference in psychological distress between the treatment and no-intervention groups. The results showed that CBT had a significant effect on psychological distress of awaiting-trial prison inmates when compared to their counterparts in the no-intervention group at Time 2. Additionally, the efficacy of CBT on the psychological distress of awaiting-trial prison inmates was significantly sustained at the follow-up measurements (Time 3).
CONCLUSION


This study suggests that cognitive behavioral therapy is an effective intervention for decreasing psychological distress among awaiting-trial prison inmates. Additionally, the impactful benefit of the intervention can persist in overtime. Therefore, cognitive behavioral therapists can further explore the efficacy of CBT using various cultures.",2020,This study suggests that cognitive behavioral therapy is an effective intervention for decreasing psychological distress among awaiting-trial prison inmates.,"['awaiting-trial prison inmates', 'awaiting-trial prison inmates in Nigeria', 'psychological distress of awaiting-trial prison inmates', '34 awaiting-trial prison inmates in Enugu state Nigeria were used as the study participants']","['group cognitive-behavioral therapy', 'CBT', 'cognitive behavioral therapy']","['level of psychological distress', 'emotional distress inventory and general health Questionnaire', 'partial Eta Squared', 'psychological distress']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0451182', 'cui_str': 'General health questionnaire'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C1720127', 'cui_str': 'Eta'}]",34.0,0.0294526,This study suggests that cognitive behavioral therapy is an effective intervention for decreasing psychological distress among awaiting-trial prison inmates.,"[{'ForeName': 'Chijioke Virgilus', 'Initials': 'CV', 'LastName': 'Amoke', 'Affiliation': 'Department of Educational Foundations, Faculty of Education.'}, {'ForeName': 'Moses Onyemaechi', 'Initials': 'MO', 'LastName': 'Ede', 'Affiliation': 'Department of Educational Foundations, Faculty of Education.'}, {'ForeName': 'Bonaventure N', 'Initials': 'BN', 'LastName': 'Nwokeoma', 'Affiliation': 'Department of Sociology and Anthropology, Faculty of Social Sciences, University of Nigeria, Nsukka.'}, {'ForeName': 'Sebastian O', 'Initials': 'SO', 'LastName': 'Onah', 'Affiliation': 'Department of Sociology and Anthropology, Faculty of Social Sciences, University of Nigeria, Nsukka.'}, {'ForeName': 'Amaka B', 'Initials': 'AB', 'LastName': 'Ikechukwu-Ilomuanya', 'Affiliation': 'Department of Educational Foundations, Faculty of Education.'}, {'ForeName': 'Florence C', 'Initials': 'FC', 'LastName': 'Albi-Oparaocha', 'Affiliation': 'Department of Educational Foundations, Faculty of Education, Alex Ekwueme Federal University, Ndufu-Alike Ebonyi State.'}, {'ForeName': 'Maduka L', 'Initials': 'ML', 'LastName': 'Nweke', 'Affiliation': 'Department of Physiology, Faculty of Basic Medical Sciences, College of Medicine, University of Nigeria, Ituku Ozalla Enugu Campus.'}, {'ForeName': 'Chijioke V', 'Initials': 'CV', 'LastName': 'Amoke', 'Affiliation': 'Department of Educational Foundations, Faculty of Education.'}, {'ForeName': 'Kingsley C', 'Initials': 'KC', 'LastName': 'Amadi', 'Affiliation': 'Department of Sociology and Anthropology, Faculty of Social Sciences, University of Nigeria, Nsukka.'}, {'ForeName': 'Henry E', 'Initials': 'HE', 'LastName': 'Aloh', 'Affiliation': 'Health Economics and Research Unit, Department of Health Services, Alex Ekwueme Federal University, Ndufu-Alike Ebonyi State.'}, {'ForeName': 'Emenike N', 'Initials': 'EN', 'LastName': 'Anyaegbunam', 'Affiliation': 'Department of Psychology, Faculty of Management, Alex Ekwueme Federal University, Ndufu-Alike Ebonyi State.'}, {'ForeName': 'Chinyere A', 'Initials': 'CA', 'LastName': 'Nwajiuba', 'Affiliation': 'Department of Educational Foundations, Faculty of Education, Alex Ekwueme Federal University, Ndufu-Alike Ebonyi State.'}, {'ForeName': 'Onyeyilichukwu P', 'Initials': 'OP', 'LastName': 'Onwuama', 'Affiliation': 'Department of Sociology and Anthropology, Faculty of Social Sciences, University of Nigeria, Nsukka.'}, {'ForeName': 'Kelechi R', 'Initials': 'KR', 'LastName': 'Ede', 'Affiliation': 'Department of Agricultural Science Education, University of Nigeria, Nsukka.'}, {'ForeName': 'Agnes I', 'Initials': 'AI', 'LastName': 'Ononaiwu', 'Affiliation': 'Department of Educational Foundations, Faculty of Education.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Nweze', 'Affiliation': 'Department of Educational Foundations, Ebonyi State University, Abakaliki Nigeria.'}]",Medicine,['10.1097/MD.0000000000018034']
222,32332608,Two head positions for orotracheal intubation with the trachway videolight intubating stylet with manual in-line stabilization: A randomized controlled trial.,"BACKGROUND


The Trachway Videolight Intubating Stylet is a video-assisted system with a rigid but malleable intubating stylet that facilitates endotracheal intubation. Minimizing cervical spine movement with manual in-line stabilization is essential for patients with cervical spine injuries such as multiple trauma. However, the intubation time of the Trachway Videolight Intubating Stylet and complications associated with intubation in patients with manual in-line stabilization in the neutral-head and head-lift positions remain unclear.
METHODS


Patients (20-80 years old) who were scheduled to undergo surgery that required general anesthesia with tracheal intubation were randomly allocated to either a neutral-head (n = 62) or a head-lift position (n = 62) group. Manual in-line stabilization was performed to limit cervical spine mobility. We aimed to evaluate orotracheal intubation time and success rate in these 2 positions with the Trachway Videolight Intubating Stylet.
RESULTS


Intubation was faster in the head-lift than in the neutral-head position (20 ± 10 and 25 ± 13 seconds, respectively, P = .000); intubation was equally successful in the 2 positions (96.8% vs 96.8%). Responses to intubation did not differ between positions (heart rate, P = .142; visual analog scale scores for throat soreness, P = .54). The only significant predictor of intubation time was the body mass index in the head-lift position group (P = .005).
CONCLUSIONS


Intubation using the Trachway Videolight Intubating Stylet with manual in-line stabilization is faster in the head-lift position, and therefore preferable. However, if the head-lift position is not suitable, the neutral-head position is a sensible alternative, with comparable intubation success rate, heart rate change, and postoperative throat soreness.",2020,"Responses to intubation did not differ between positions (heart rate, P = .142; visual analog scale scores for throat soreness, P = .54).","['patients with manual in-line stabilization in the neutral-head and head-lift positions remain unclear', 'Patients (20-80 years old) who were scheduled to undergo surgery that required general anesthesia with tracheal intubation', 'patients with cervical spine injuries']","['manual in-line stabilization', 'neutral-head (n\u200a=\u200a62) or a head-lift position', 'Trachway Videolight', 'orotracheal intubation with the trachway videolight intubating stylet with manual in-line stabilization']","['visual analog scale scores for throat soreness', 'intubation time of the Trachway Videolight', 'orotracheal intubation time and success rate', 'intubation time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0432666', 'cui_str': 'Injury of cervical spine'}]","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0396621', 'cui_str': 'Orotracheal intubation'}, {'cui': 'C0183663', 'cui_str': 'Stylet'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0396621', 'cui_str': 'Orotracheal intubation'}]",,0.0898193,"Responses to intubation did not differ between positions (heart rate, P = .142; visual analog scale scores for throat soreness, P = .54).","[{'ForeName': 'Wei-Hung', 'Initials': 'WH', 'LastName': 'Chan', 'Affiliation': 'Department of Anesthesiology, Tri-Service General Hospital.'}, {'ForeName': 'Chiao-Pei', 'Initials': 'CP', 'LastName': 'Cheng', 'Affiliation': 'Department of Anesthesiology, Tri-Service General Hospital.'}, {'ForeName': 'Yu-Lung', 'Initials': 'YL', 'LastName': 'Chiu', 'Affiliation': 'Graduate Institute of Medical Sciences.'}, {'ForeName': 'Yung-Chi', 'Initials': 'YC', 'LastName': 'Hsu', 'Affiliation': 'Department of Anesthesiology, Tri-Service General Hospital.'}, {'ForeName': 'Mei-Hua', 'Initials': 'MH', 'LastName': 'Hu', 'Affiliation': 'Division of Pediatric General Medicine, Chang Gung Memorial Hospital, LinKou Branch.'}, {'ForeName': 'Go-Shine', 'Initials': 'GS', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Tri-Service General Hospital.'}]",Medicine,['10.1097/MD.0000000000019645']
223,32332617,"Effectiveness of a multifactorial intervention, consisting of self-management of antihypertensive medication, self-measurement of blood pressure, hypocaloric and low sodium diet, and physical exercise, in patients with uncontrolled hypertension taking 2 or more antihypertensive drugs: The MEDICHY study.","INTRODUCTION


High blood pressure is the leading modifiable risk factor for cardiovascular disease, and is associated with high morbidity and mortality and with significant health care costs for individuals and society. However, fewer than half of the patients with hypertension receiving pharmacological treatment have adequate blood pressure control. The main reasons for this are therapeutic inertia, lack of adherence to treatment, and unhealthy lifestyle (i.e., excess dietary fat and salt, sedentary lifestyle, and overweight). Cardiovascular risk and mortality are greater in hypertensive patients who are receiving treatment but have suboptimal control of blood pressure.
METHODS/DESIGN


This is a multicentre, parallel, 2-arm, single-blind (outcome assessor), controled, cluster-randomized clinical trial. General practitioners and nurses will be randomly allocated to the intervention group (self-management of antihypertensive medication, self-measurement of blood pressure, hypocaloric and low sodium diet, and physical exercise) or the control group (regular clinical practice). A total of 424 patients in primary care centers who use 2 or more antihypertensive drugs and blood pressure of at least 130/80 during 24-hambulatory blood pressure monitoring will be recruited. The primary outcome is systolic blood pressure at 12 months. The secondary outcomes are blood pressure control (<140/90 mm Hg); quality of life (EuroQol 5D); direct health care costs; adherence to use of antihypertensive medication; and cardiovascular risk (REGICOR and SCORE scales).
DISCUSSION


This trial will be conducted in the primary care setting and will evaluate the impact of a multifactorial intervention consisting of self-management of blood pressure, antihypertensive medications, and lifestyle modifications (hypocaloric and low sodium diet and physical exercise).",2020,"Cardiovascular risk and mortality are greater in hypertensive patients who are receiving treatment but have suboptimal control of blood pressure.
","['patients with uncontrolled hypertension taking 2 or more antihypertensive drugs', 'General practitioners and nurses', 'hypertensive patients who are receiving treatment but have suboptimal control of blood pressure', '424 patients in primary care centers who use 2 or more antihypertensive drugs and blood pressure of at least 130/80 during 24-hambulatory blood pressure monitoring will be recruited']","['multifactorial intervention, consisting of self-management of antihypertensive medication, self-measurement of blood pressure, hypocaloric and low sodium diet, and physical exercise', 'blood pressure, antihypertensive medications, and lifestyle modifications (hypocaloric and low sodium diet and physical exercise', 'intervention group (self-management of antihypertensive medication, self-measurement of blood pressure, hypocaloric and low sodium diet, and physical exercise) or the control group (regular clinical practice']","['systolic blood pressure', 'Cardiovascular risk and mortality', 'adequate blood pressure control', 'blood pressure control (<140/90\u200amm Hg); quality of life (EuroQol 5D); direct health care costs; adherence to use of antihypertensive medication; and cardiovascular risk (REGICOR and SCORE scales']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0026426', 'cui_str': 'Blood pressure monitoring'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0012169', 'cui_str': 'Low sodium diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",424.0,0.0453177,"Cardiovascular risk and mortality are greater in hypertensive patients who are receiving treatment but have suboptimal control of blood pressure.
","[{'ForeName': 'Fabián', 'Initials': 'F', 'LastName': 'Unda Villafuerte', 'Affiliation': ""Coll D'en Rabassa Healthcare Centre.""}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Llobera Cànaves', 'Affiliation': 'Primary Care Research Unit of Mallorca, Balearic Health Services (IB-Salut).'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Lorente Montalvo', 'Affiliation': 'Santa Ponça Health Care Centre.'}, {'ForeName': 'María Lucía', 'Initials': 'ML', 'LastName': 'Moreno Sancho', 'Affiliation': 'Son Cladera Healthcare Centre, Balearic Health Services (IB-Salut).'}, {'ForeName': 'Bartolomé', 'Initials': 'B', 'LastName': 'Oliver Oliver', 'Affiliation': 'Spanish Society of Family and Community Pharmacy.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Bassante Flores', 'Affiliation': 'Palliative Care Health Centre.'}, {'ForeName': 'Andreu', 'Initials': 'A', 'LastName': 'Estela Mantolan', 'Affiliation': 'Dalt San Joan Healthcare Centre, Mahó, Menorca.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Pou Bordoy', 'Affiliation': 'Camp Redó Healthcare Centre.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Rodríguez Ruiz', 'Affiliation': 'Primary Care Research Unit of Menorca, Balearic Health Services (IB-Salut), Menorca, Balearic Islands, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Requena Hernández', 'Affiliation': ""Coll D'en Rabassa Healthcare Centre.""}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Leiva', 'Affiliation': 'Primary Care Research Unit of Mallorca, Balearic Health Services (IB-Salut).'}, {'ForeName': 'Matíes', 'Initials': 'M', 'LastName': 'Torrent Quetglas', 'Affiliation': ""Institut d'investigació Sanitària Illes Balears.""}, {'ForeName': 'José María', 'Initials': 'JM', 'LastName': 'Coll Benejam', 'Affiliation': ""Institut d'investigació Sanitària Illes Balears.""}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': ""D'Agosto Forteza"", 'Affiliation': 'Son Serra La Vileta Healthcare Centre.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Rigo Carratalà', 'Affiliation': ""Institut d'investigació Sanitària Illes Balears.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000019769']
224,32332635,A randomized controlled clinical study of acupuncture therapy for Seborrheic alopecia in young and middle ages: Study protocol clinical trial (SPIRIT compliant).,"INTRODUCTION


Seborrheic alopecia (SA) has clinical manifestations, duration of disease, and priorities. In the current situation where there are many and complicated clinical treatments, Western medicine treatment can delay and control the development of the disease and promote hair regeneration. However, some patients may aggravate symptoms after taking the drug, and the condition is easy to repeat after stopping the drug. Acupuncture is an important method for non-surgical treatment of SA, and it has various methods, low side effects, high safety, and simple and economical. Therefore, we will use a clinical randomized controlled study to explore the effect of acupuncture on SA, and provide a new idea and reference for the treatment of this disease.
METHODS/DESIGN


We will select 60 patients diagnosed with SA. They will be randomly divided into intervention group and control groups. The control group will be given conventional treatment measures. The intervention group will receive acupuncture. Efficacy will be evaluated by comparing the skin lesion score and dermatological quality of life index before and after treatment.
DISCUSSION


This trial may provide evidence regarding the clinical effectiveness, safety, and cost-effectiveness of acupuncture for patients with SA.
TRIAL REGISTRATION NUMBER


CTR2000030430.",2020,"Efficacy will be evaluated by comparing the skin lesion score and dermatological quality of life index before and after treatment.
","['patients with SA', 'Seborrheic alopecia in young and middle ages', '60 patients diagnosed with SA']","['acupuncture therapy', 'Acupuncture', 'acupuncture']",['skin lesion score and dermatological quality of life index'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0026062', 'cui_str': 'Middle-age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0037284', 'cui_str': 'Skin lesion'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011625', 'cui_str': 'DERMATOLOGICALS'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index'}]",60.0,0.0791902,"Efficacy will be evaluated by comparing the skin lesion score and dermatological quality of life index before and after treatment.
","[{'ForeName': 'Qiulian', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Graduate student of HeBei North University.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Department of Dermatology,Huabei Petroleum General Hospital.'}, {'ForeName': 'Longjun', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Graduate Student of Hebei University of Chinese medicine.'}, {'ForeName': 'Jinfang', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Dermatology, The First Hospital of Hebei Medical University.'}, {'ForeName': 'Bichen', 'Initials': 'B', 'LastName': 'Sun', 'Affiliation': 'Department of Traditional Chinese Medicine, Huabei Petroleum General Hospital.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Qin Huang Dao Hospital of Traditional Chinese Medicine of HeBei North University,China.'}]",Medicine,['10.1097/MD.0000000000019842']
225,31837944,Ho:YAG laser versus pneumatic lithotripsy for management of pediatric ureteral stones: a prospective-comparative analysis with adults.,"BACKGROUND


There are limited number of studies comparing the results of Holmium:YAG laser lithotripsy (LL) and pneumatic lithotripsy (PL) for pediatric ureteral stones.
OBJECTIVES


To perform a comparative analysis of LL and PL in the management of ureteral stones in children and adults.
STUDY DESIGN


Ninety-eight children (56 boys and 42 girls) and 623 adults (360 men and 263 women), who were treated for ureteral stones at our clinic between 2017 and 2019, were the subjects of this study. Patients were grouped according to their age as group 1 (n:98, pediatric [<18 age]) and group 2 (n:623, adult [≥18 age]). The patients were then grouped according to lithotripter type as laser (n:580) and pneumatic (n:141). The effects of lithotripter type, stone size and location, and operative times on success and complication rates were investigated.
RESULTS


In both groups, mean operation time was in favor of PL (14.6 vs 22.8 min, p = 0.042 and 26.4 vs 36.3 min, p = 0.013, respectively). In both groups, overall stone-free rates (SFR) were in favor of LL (86.8% vs 66.7%, p < 0.001, and 83% vs 73.9%, p = 0.005, respectively), but there was no significant difference in overall SFRs between adults and children (78.4% vs 76.7, p = 0.390). Retreatment rates were higher in the pneumatic group in both children and adults (p = 0.026 and p = 0.041, respectively). While there was no significant difference in the overall complication rates between adults and children (53.5% vs 40.6%, p = 0.816), the rate of complications with LL was lower in adults (37.7% vs 69.4%, p < 0.001) (TABLE).
DISCUSSION


This paper is the first to report a comparative analysis of factors affecting URS success in adults and children. SFRs were higher in all ureteral locations for LL. LL, lower ureteral location, and <6 mm ureteral stone were determined as the predictors of success for both pediatric and adult patients. The presence of multiple surgeons with different levels of experience is the main limitation of this study.
CONCLUSION


Both LL and PL are safe in children and adults with similar clinically insignificant complication rates. However, in the short term, LL provides better SFRs in both children and adults, especially in the upper ureteral stones. Surgeons should decide the energy technique to be used in URS according to the characteristics of the stone rather than the patient's age group.",2020,"Retreatment rates were higher in the pneumatic group in both children and adults (p = 0.026 and p = 0.041, respectively).","['Ninety-eight children (56 boys and 42 girls) and 623 adults (360 men and 263 women), who were treated for ureteral stones at our clinic between 2017 and 2019, were the subjects of this study', 'adults and children', 'pediatric ureteral stones', 'Patients were grouped according to their age as group 1 (n:98, pediatric [<18 age]) and group 2 (n:623, adult [≥18 age', 'children and adults']","['LL and PL', 'Holmium:YAG laser lithotripsy (LL) and pneumatic lithotripsy (PL', 'Ho:YAG laser versus pneumatic lithotripsy', 'LL']","['LL, lower ureteral location, and <6\xa0mm ureteral stone', 'overall complication rates', 'Retreatment rates', 'overall stone-free rates (SFR', 'rate of complications with LL', 'overall SFRs', 'SFRs', 'success and complication rates', 'mean operation time']","[{'cui': 'C4319627', 'cui_str': 'Ninety-eight'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0041952', 'cui_str': 'Ureterolithiasis'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}]","[{'cui': 'C0042950', 'cui_str': 'Will'}, {'cui': 'C0019846', 'cui_str': 'Holmium'}, {'cui': 'C0587723', 'cui_str': 'Lasers, Yttrium Aluminum Garnet'}, {'cui': 'C0023878', 'cui_str': 'Litholapaxy'}, {'cui': 'C0441085', 'cui_str': 'Ho YAG Lasers'}]","[{'cui': 'C0042950', 'cui_str': 'Will'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0041952', 'cui_str': 'Ureterolithiasis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C1264665', 'cui_str': 'Substance fraction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",98.0,0.0433744,"Retreatment rates were higher in the pneumatic group in both children and adults (p = 0.026 and p = 0.041, respectively).","[{'ForeName': 'Fuat', 'Initials': 'F', 'LastName': 'Kızılay', 'Affiliation': 'Department of Urology, Faculty of Medicine, Ege University, 35100, Izmir, Turkey. Electronic address: fuatkizilay@gmail.com.'}, {'ForeName': 'Serdar', 'Initials': 'S', 'LastName': 'Kalemci', 'Affiliation': 'Department of Urology, Faculty of Medicine, Ege University, 35100, Izmir, Turkey.'}, {'ForeName': 'Burak', 'Initials': 'B', 'LastName': 'Turna', 'Affiliation': 'Department of Urology, Faculty of Medicine, Ege University, 35100, Izmir, Turkey.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Şimşir', 'Affiliation': 'Department of Urology, Faculty of Medicine, Ege University, 35100, Izmir, Turkey.'}, {'ForeName': 'Oktay', 'Initials': 'O', 'LastName': 'Nazlı', 'Affiliation': 'Department of Urology, Faculty of Medicine, Ege University, 35100, Izmir, Turkey.'}]",Journal of pediatric urology,['10.1016/j.jpurol.2019.11.006']
226,32334176,"The RESPECT trial-Replacement of peripheral intravenous catheters according to clinical reasons or every 96 hours: A randomized, controlled, non-inferiority trial.","BACKGROUND


Peripheral intravenous catheters are widely used for infusion therapy. To prevent phlebitis, routine catheter replacement at 72 or 96 hours remains widely practiced.
OBJECTIVE


To investigate the non-inferiority of clinically indicated peripheral intravenous catheter replacement compared with routine replacement every 96 hours to prevent phlebitis. Phlebitis severity, catheter indwelling time, and other catheter failure types were also compared.
SETTING


Multi-center trial in wards at two hospitals in Sao Paulo, Brazil.
DESIGN


The REplacement of PEripheral intravenous CaTheters according to clinical signs or every 96 hours (RESPECT) trial was a Randomized, non-blinded, controlled, non-inferiority trial.
PARTICIPANTS


1319 patients were enrolled with the following inclusion criteria: aged ≥18 years, expected peripheral intravenous therapy for ≥96 hours; peripheral intravenous catheters inserted in the selected wards, intensive care units, or surgical centers; and informed consent provided. Exclusion criteria were: bloodstream infection and/or sepsis, neutrophil count of ≤1000/mm 3 , and simultaneous use of more than one peripheral intravenous catheter. Recruitment occurred within 96 hours of peripheral intravenous catheter insertion. Randomization was performed using a computer-generated, concealed list.
METHODS


As intervention, clinically indicated replacement group patients underwent peripheral intravenous catheter removal only at the end of therapy or in the presence of phlebitis, infiltration, occlusion, displacement, accidental removal, or bloodstream infection. Routine 96-h replacement group patients (control) had their catheters replaced every 96-h, unless clinical reasons required earlier replacement. The primary outcome was Phlebitis and the analyses were carried out on intention-to-treat and per-protocol bases.
RESULTS


Demographic and clinical variables were similar between groups, with the exception to type of admission (p = 0.025) more frequent in clinically indicated patients and surgical on routine replacement group. Of the 1319 patients, 119 (9.0%) developed phlebitis with no between-group difference (p = 0.162); these patients used 2747 peripheral intravenous catheters, being that 134 presented phlebitis. Phlebitis/1000 catheter-days, was 14.9 in the clinically indicated group and 23.8 in the routine replacement group (p = 0.006). The survival analysis showed no significant between-group difference in the occurrence of the first phlebitis episode.
CONCLUSIONS


Clinically indicated peripheral intravenous catheter replacement was not inferior to routine (96 hours) replacement regarding phlebitis occurrence, and was associated with significantly less phlebitis per 1000 days.
TRIAL REGISTRATION


Registered with www.clinicaltrials.gov (NCT02568670).",2020,"Of the 1319 patients, 119 (9.0%) developed phlebitis with no between-group difference (p = 0.162); these patients used 2747 peripheral intravenous catheters, being that 134 presented phlebitis.","['Multi-center trial in wards at two hospitals in Sao Paulo, Brazil', '1319 patients were enrolled with the following inclusion criteria: aged ≥18 years, expected peripheral intravenous therapy for ≥96\xa0h; peripheral intravenous catheters inserted in the selected wards, intensive care units, or surgical centers; and informed consent provided']","['peripheral intravenous catheters', 'peripheral intravenous catheter replacement', 'peripheral intravenous catheter removal']","['Phlebitis', 'phlebitis', 'intention-to-treat and per-protocol bases', 'Phlebitis severity, catheter indwelling time, and other catheter failure types']","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1862322', 'cui_str': 'Southeast Asian ovalocytosis'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0455142', 'cui_str': 'Intravenous therapy'}, {'cui': 'C0179768', 'cui_str': 'Peripheral intravenous catheter'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]","[{'cui': 'C0179768', 'cui_str': 'Peripheral intravenous catheter'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0031542', 'cui_str': 'Phlebitis'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0007439', 'cui_str': 'In-Dwelling Catheters'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",1319.0,0.175394,"Of the 1319 patients, 119 (9.0%) developed phlebitis with no between-group difference (p = 0.162); these patients used 2747 peripheral intravenous catheters, being that 134 presented phlebitis.","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Vendramim', 'Affiliation': 'Specialist in pediatric intensive care, M.Sc., Ph.D. in Health Science of Federal University of Sao Paulo, 258 Aimberê, St. Sao Paulo, Brazil. Electronic address: patvendramim@gmail.com.'}, {'ForeName': 'A F M', 'Initials': 'AFM', 'LastName': 'Avelar', 'Affiliation': 'Federal University of Sao Paulo, Brazil. Electronic address: ariane.machado@unifesp.br.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Rickard', 'Affiliation': 'Griffith University - Australia, Australia. Electronic address: c.rickard@griffith.edu.au.'}, {'ForeName': 'M D L G', 'Initials': 'MDLG', 'LastName': 'Pedreira', 'Affiliation': 'Federal University of Sao Paulo, Brazil. Electronic address: mpedreira@unifesp.br.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2019.103504']
227,31714640,Therapeutic Drug Monitoring of Newer Antiepileptic Drugs: A Randomized Trial for Dosage Adjustment.,"OBJECTIVE


Therapeutic drug monitoring (TDM) of antiepileptic drugs (AEDs) is widely established for older generation AEDs, whereas there is limited evidence about newer AEDs. Our aim is to assess the benefit of TDM of newer generation AEDs in epilepsy.
METHODS


We performed a randomized, controlled trial comparing systematic with rescue TDM of lamotrigine, levetiracetam, oxcarbazepine, topiramate, brivaracetam, zonisamide, or pregabalin. Participants were adults with epilepsy, in whom treatment with newer generation AEDs was initiated or needed adjustment. In the systematic TDM arm, AED plasma levels were available at each appointment, whereas in the rescue TDM arm, levels were known only if a study endpoint was reached (inefficacy or adverse events). The primary outcome was the proportion of participants followed 1 year without reaching one of the predefined endpoints.
RESULTS


A total of 151 participants were enrolled; global retention in the study was similar in both arms (56% overall, 58% in the systematic, and 53% in the rescue TDM arm, p = 0.6, Cox regression). There was no difference in terms of outcome regarding treatment efficacy or tolerability. Partial adherence of clinicians to TDM (adjusting or not AED dosage based on blood levels) did not explain this lack of benefit.
INTERPRETATION


This study provides class A evidence that systematic drug level monitoring of newer generation AEDs does not bring tangible benefits in the management of patients with epilepsy. Poor correlation between clinical effects and drug levels likely accounts for this finding. However, TDM is useful in several situations, such as pregnancy, as well as when there are compliance issues. ANN NEUROL 2020;87:22-29.",2020,There was no difference in term of outcome regarding treatment efficacy or tolerability.,"['Participants were adults with epilepsy, in whom treatment with newer generation AEDs was initiated or needed adjustment', 'patients with epilepsy', '151 participants were enrolled']","['lamotrigine, levetiracetam, oxcarbazepine, topiramate, brivaracetam, zonisamide, or pregabalin', 'TDM']","['efficacy or tolerability', 'proportion of participants followed over one year without reaching one of the predefined endpoint', 'global retention', 'AED plasma levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0064636', 'cui_str': 'lamotrigine'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0069751', 'cui_str': 'oxcarbazepine'}, {'cui': 'C0076829', 'cui_str': 'topiramate'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0078844', 'cui_str': 'zonisamide'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}]","[{'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",151.0,0.217395,There was no difference in term of outcome regarding treatment efficacy or tolerability.,"[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Aícua-Rapún', 'Affiliation': 'Department of Clinical Neurosciences, Neurology Service, Lausanne University Hospital (Vaud University Hospital Center) and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'André', 'Affiliation': 'Service of Clinical Pharmacology, Lausanne University Hospital (Vaud University Hospital Center) and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Andrea O', 'Initials': 'AO', 'LastName': 'Rossetti', 'Affiliation': 'Department of Clinical Neurosciences, Neurology Service, Lausanne University Hospital (Vaud University Hospital Center) and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Ryvlin', 'Affiliation': 'Department of Clinical Neurosciences, Neurology Service, Lausanne University Hospital (Vaud University Hospital Center) and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Andreas F', 'Initials': 'AF', 'LastName': 'Hottinger', 'Affiliation': 'Department of Clinical Neurosciences, Neurology Service, Lausanne University Hospital (Vaud University Hospital Center) and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Laurent A', 'Initials': 'LA', 'LastName': 'Decosterd', 'Affiliation': 'Laboratory of Clinical Pharmacology Laboratory, Lausanne University Hospital (Vaud University Hospital Center) and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Buclin', 'Affiliation': 'Service of Clinical Pharmacology, Lausanne University Hospital (Vaud University Hospital Center) and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Novy', 'Affiliation': 'Department of Clinical Neurosciences, Neurology Service, Lausanne University Hospital (Vaud University Hospital Center) and University of Lausanne, Lausanne, Switzerland.'}]",Annals of neurology,['10.1002/ana.25641']
228,32332636,Effect of electroacupuncture on diabetic neurogenic bladder: A randomized controlled trial protocol.,"BACKGROUND


The most common and bothersome lower urinary tract complication of diabetes mellitus is diabetic neurogenic bladder (DNB). Acupuncture has certain advantages in treating bladder dysfunction including urinary retention and incontinence. Therefore, we think that electroacupuncture (EA) may be beneficial to DNB patients. However, it is not clear whether EA combined with basic western medicine could optimize the therapeutic effect for DNB.
METHOD/DESIGN


This is a sham-controlled, patient-blinded, pioneer randomized controlled trial (RCT). One hundred fifty eligible patients will be randomly divided into 3 groups: A. basic western medicine (BWC), B. EA with BWC, C. sham EA with BWC. EA treatment will be given twice a week for 12 weeks at bilateral BL23, BL32, BL33, and BL35. The BWC group will received Alpha-lipoic acid (ALA) and methylcobalamin (MC) treatment for 12 weeks, 2 treatment sessions per week. The primary outcome is scored by the 72-hour bladder diary (72h-BD). The secondary outcomes will be scored by the American Urological Association symptom index (AUA-SI), Post-void residual urine volume (PVR) and urodynamic tests. All the assessments will be conducted at baseline and the 12th weeks after the intervention starts. The follow-up assessments will be performed with 72h-BD and AUA-SI in the 4th, 12th, and 24th weeks after intervention ends.
DISCUSSION


This trial protocol provides an example of the clinical application acupuncture treatment in the management of DNB. This RCT will provide us information on the effect of treating DNB patients with only acupuncture, western medicine therapy (ALA + MC) as well as the combination of both. The additive effect or synergistic effect of acupuncture and basic western medicine will then be analyzed.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR2000030421.",2020,"EA treatment will be given twice a week for 12 weeks at bilateral BL23, BL32, BL33, and BL35.","['diabetic neurogenic bladder', 'One hundred fifty eligible patients']","['Alpha-lipoic acid (ALA) and methylcobalamin (MC', 'basic western medicine (BWC), B. EA with BWC, C. sham EA with BWC', 'electroacupuncture', 'Acupuncture', 'electroacupuncture (EA', 'acupuncture']","['72-hour bladder diary (72h-BD', 'American Urological Association symptom index (AUA-SI), Post-void residual urine volume (PVR) and urodynamic tests']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0005697', 'cui_str': 'Neurogenic bladder'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C0065844', 'cui_str': 'mecobalamin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart'}, {'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0429774', 'cui_str': 'Residual urine volume'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",150.0,0.160783,"EA treatment will be given twice a week for 12 weeks at bilateral BL23, BL32, BL33, and BL35.","[{'ForeName': 'Xuke', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Shengju', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Qiu', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine.'}]",Medicine,['10.1097/MD.0000000000019843']
229,32332638,The efficacy of jade moxibustion in knee osteoarthritis.,"INTRODUCTION


This study aims to compare clinical effect between Jade moxibustion and traditional moxibustion, and to determine the clinical effect of Jade moxibustion on knee osteoarthritis (KOA).
METHODS/DESIGN


This is a 2-parallel-group, randomized controlled trial. A total of 148 subjects with KOA (Kellgren-Lawrence grade II or III) will be recruited and randomized to receive Jade moxibustion treatment or a traditional moxibustion treatment in a 1:1 ratio. Jade moxibustion group: The affected knee of the subjects will be covered with jade kneepad. Traditional moxibustion group: Chosen the ST35, ST34, EX-LE4, SP10 and Ashi points at the affected knee. The subjects will receive treatment three times a week, altogether 12 times in 4 weeks. The main outcomes are WOMAC knee pain score, knee function score and SF-36 quality of life questionnaire changes at the 4th week. Secondary outcomes include WOMAC knee pain score and knee function score, overall clinical efficacy evaluation, medication, safety evaluation at the 2nd, 12th, and 24th week, and cytokines related to osteoarthritis in serum.
DISCUSSION


This randomized controlled trial used traditional moxibustion as a control group to provide rigorous evidence for the clinical efficacy and safety of Jade moxibustion in treatment of KOA.
TRIAL REGISTRATION


ISRCTN registry, No 21174552. Registered on 28 February 2020.",2020,"The main outcomes are WOMAC knee pain score, knee function score and SF-36 quality of life questionnaire changes at the 4th week.","['knee osteoarthritis', '148 subjects with KOA (Kellgren-Lawrence grade II or III']","['Jade moxibustion and traditional moxibustion', 'jade moxibustion', 'Jade moxibustion', 'traditional moxibustion', 'Jade moxibustion treatment or a traditional moxibustion treatment']","['knee osteoarthritis (KOA', 'WOMAC knee pain score, knee function score and SF-36 quality of life questionnaire changes', 'WOMAC knee pain score and knee function score, overall clinical efficacy evaluation, medication, safety evaluation at the 2nd, 12th, and 24th week, and cytokines related to osteoarthritis in serum']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",148.0,0.0669277,"The main outcomes are WOMAC knee pain score, knee function score and SF-36 quality of life questionnaire changes at the 4th week.","[{'ForeName': 'Lusheng', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine.'}, {'ForeName': 'Zouqin', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Shanghai Pudong New Area Hospital of Traditional Chinese Medicine, Pudong New Area, Shanghai, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Cheng', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine.'}, {'ForeName': 'Haiping', 'Initials': 'H', 'LastName': 'Deng', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine.'}, {'ForeName': 'Xueyong', 'Initials': 'X', 'LastName': 'Shen', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine.'}]",Medicine,['10.1097/MD.0000000000019845']
230,31782181,Randomized Placebo-Controlled Trial of Intravenous Immunoglobulin in Autoimmune LGI1/CASPR2 Epilepsy.,"OBJECTIVE


Drug-resistant seizures are common in patients with leucine-rich, glioma-inactivated 1 (LGI1)-IgG associated and contactin-associated protein-like 2 (CASPR2)-IgG associated encephalitis. We performed the first randomized double-blind placebo-controlled trial to evaluate efficacy of intravenous immunoglobulin (IVIG) in reducing seizure frequency.
METHODS


Our enrollment goal was 30 LGI1/CASPR2-IgG-seropositive adult patients with ≥2 seizures per week. Patients were randomized to receive IVIG (0.5g/kg day 1, 1g/kg day 2, 0.6g/kg weeks 3 and 5) or volume-matched intravenous normal saline. Following the blinded phase, the nonresponders in the placebo group received IVIG. The primary clinical outcome was 50% reduction in seizure frequency from baseline to 5 weeks.
RESULTS


After enrollment of 17 patients (LGI1-IgG, 14; CASPR2-IgG, 3) over 34 months, the study was terminated due to slow enrollment. Six of 8 patients in the IVIG group were responders, compared to 2 of 9 in the placebo group (p = 0.044, odds ratio = 10.5, 95% confidence interval = 1.1-98.9). For the LGI1-IgG seropositive subgroup, 6 of 8 patients in the IVIG group were responders, compared to zero of 6 in the placebo group. Two LGI1-IgG-seropositive patients receiving IVIG, but none receiving placebo, were seizure-free at the end of the blinded phase. Four of the 6 patients entering the open-label IVIG arm reported ≥50% reduction in seizure frequency. There were no correlations with LGI1/CASPR2-IgG1-4 subclasses.
INTERPRETATION


Superiority of IVIG to placebo reached statistical significance for the primary endpoint for all patients and the subset with LGI1-IgG. These results have to be interpreted with the caveat that the study did not reach its originally selected sample size. ANN NEUROL 2020;87:313-323.",2020,"INTERPREATION


Superiority of IVIG to placebo reached statistical significance for the primary end-point for all patients and the subset with LGI1-IgG.","['30 LGI1/CASPR2-IgG-seropositive adult patients with ≥2 seizures per-week', 'autoimmune LGI1/CASPR2 epilepsy', 'patients with Leucine-rich, glioma-inactivated-1 (LGI1) and contactin-associated-protein-like-2 (CASPR2)-IgG associated encephalitis']","['Placebo', 'volume-matched intravenous normal saline', 'placebo', 'IVIG', 'intravenous immunoglobulin (IVIG']",['seizure frequency'],"[{'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0521143', 'cui_str': 'Seropositive (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0017638', 'cui_str': 'Glial Cell Tumors'}, {'cui': 'C0056257'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0014038', 'cui_str': 'Inflammation, Brain'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}]","[{'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",,0.667386,"INTERPREATION


Superiority of IVIG to placebo reached statistical significance for the primary end-point for all patients and the subset with LGI1-IgG.","[{'ForeName': 'Divyanshu', 'Initials': 'D', 'LastName': 'Dubey', 'Affiliation': 'Department of Neurology and Immunology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Britton', 'Affiliation': 'Department of Neurology and Immunology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McKeon', 'Affiliation': 'Department of Neurology and Immunology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Avi', 'Initials': 'A', 'LastName': 'Gadoth', 'Affiliation': 'Department of Neurology and Immunology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Zekeridou', 'Affiliation': 'Department of Neurology and Immunology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Sebastian A', 'Initials': 'SA', 'LastName': 'Lopez Chiriboga', 'Affiliation': 'Department of Neurology and Immunology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Devine', 'Affiliation': 'Department of Neurology and Immunology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Jane H', 'Initials': 'JH', 'LastName': 'Cerhan', 'Affiliation': 'Department of Neurology and Immunology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Dunlay', 'Affiliation': 'Department of Neurology and Immunology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Sagen', 'Affiliation': 'Department of Neurology and Immunology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Ramberger', 'Affiliation': 'Oxford Autoimmune Neurology Group, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Waters', 'Affiliation': 'Oxford Autoimmune Neurology Group, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sarosh R', 'Initials': 'SR', 'LastName': 'Irani', 'Affiliation': 'Oxford Autoimmune Neurology Group, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sean J', 'Initials': 'SJ', 'LastName': 'Pittock', 'Affiliation': 'Department of Neurology and Immunology, Mayo Clinic, Rochester, MN.'}]",Annals of neurology,['10.1002/ana.25655']
231,31899024,Comparative Effectiveness of Topically Administered Tranexamic Acid Versus Topical Oxymetazoline Spray for Achieving Hemostasis in Epistaxis.,"BACKGROUND


The use of tranexamic acid (TXA) has recently gained popularity as a treatment modality for epistaxis in the emergency department. Previous studies have compared topical TXA to nasal packing. However, topical TXA has not yet been compared with topical oxymetazoline in the treatment of epistaxis.
OBJECTIVES


This study compares the efficacy of the intravenous formulation of TXA applied topically vs. the vasoconstrictor oxymetazoline applied topically in achieving hemostasis in patients presenting to the emergency department with anterior epistaxis.
METHODS


In this prospective study, patients presenting to the emergency department with the chief complaint of epistaxis, and meeting inclusion criteria, were allocated into 2 treatment groups; topical oxymetazoline vs. topical application of the intravenous preparation of TXA. Patients were assessed for time to hemostasis in the emergency department as well as the occurrence of rebleeding within the next 48 h after discharge.
RESULTS


Hemostasis was achieved in 14 (78%) of the 18 patients in the TXA group compared with 7 (35%) of the 20 patients in the oxymetazoline group. While there were occurrences of rebleeding in the emergency department before discharge and at 48 h in both groups, 11 patients in the TXA group had no recurrence of bleeding compared with 5 in the oxymetazoline group.
CONCLUSION


This study demonstrated that the topical application of the intravenous preparation of TXA is more effective than topical oxymetazoline for achievement of hemostasis in anterior epistaxis. This has clinical significance toward preventing an avoidable need for escalation of treatment that could include applying nasal packing or cautery as well as preventing avoidable return emergency department visits. These outcomes would increase cost, potentially increase patient discomfort, and prolong emergency department throughput time.",2020,"RESULTS


Hemostasis was achieved in 14 (78%) of the 18 patients in the TXA group compared with 7 (35%) of the 20 patients in the oxymetazoline group.","['patients presenting to the emergency department with the chief complaint of epistaxis, and meeting inclusion criteria', 'Epistaxis', 'patients presenting to the emergency department with anterior epistaxis']","['tranexamic acid (TXA', 'vasoconstrictor oxymetazoline', 'topical TXA', 'topical oxymetazoline', 'oxymetazoline', 'TXA', 'Tranexamic Acid Versus Topical Oxymetazoline Spray', 'topical oxymetazoline vs. topical application of the intravenous preparation of TXA']","['recurrence of bleeding', 'occurrences of rebleeding', 'patient discomfort, and prolong emergency department throughput time', 'occurrence of rebleeding', 'time to hemostasis', 'Hemostasis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0014591', 'cui_str': 'Nosebleed'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0339815', 'cui_str': 'Anterior epistaxis (disorder)'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0042397', 'cui_str': 'Vasoactive Agonists'}, {'cui': 'C0030071', 'cui_str': 'Oxymetazoline'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}]",,0.0246286,"RESULTS


Hemostasis was achieved in 14 (78%) of the 18 patients in the TXA group compared with 7 (35%) of the 20 patients in the oxymetazoline group.","[{'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Whitworth', 'Affiliation': 'Lakeland Health Emergency Medicine Residency Program, Lakeland Health, Saint Joseph, Michigan.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Johnson', 'Affiliation': 'Lakeland Health Emergency Medicine Residency Program, Lakeland Health, Saint Joseph, Michigan.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Wisniewski', 'Affiliation': 'Michigan State University College of Osteopathic Medicine, East Lansing, Michigan.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Schrader', 'Affiliation': 'Lakeland Health Emergency Medicine Residency Program, Lakeland Health, Saint Joseph, Michigan.'}]",The Journal of emergency medicine,['10.1016/j.jemermed.2019.11.038']
232,31786228,One week stenting after pediatric laparoscopic pyeloplasty; is it enough?,"INTRODUCTION


The use of ureteric stents for urinary diversion after pediatric dismembered pyeloplasty and its duration remain debatable. Classically, an indwelling Double J ureteric stent has to be left for 4-6 weeks. However, such a duration is not free of stent-related complications, in addition to the need to remove it under general anesthesia in the pediatric age group.
OBJECTIVES


This study aims to evaluate the outcome of short-term stenting after laparoscopic pyeloplasty in pediatric sector.
METHODS


A prospective randomized study of 37 children (less than 16 years-old) with pelvi-ureteric junction obstruction (PUJO) were managed by laparoscopic pyeloplasty by the same surgeon in the period between April 2015 and September 2017. In group A (18 patients), the DJ was removed after 4 weeks under general anesthesia, while in group B (19 patients), the DJ was fixed to the urethral catheter by a stitch, and it was removed with the urethral catheter after one week in the outpatient office. All patients were followed regularly for symptomatic improvement. Urine culture and sensitivity was done 1 month postoperatively. Abdominal ultrasound was done at 3, 6, 12 months and annually thereafter, while renal isotope scanning was done after 6 months.
RESULTS


There were no significant differences between both groups regarding operative duration, postoperative leakage, hospital stay, early postoperative complications. Both groups improved after pyeloplasty with no significant differences regarding symptoms, follow-up ultrasound, and renal scanning. The incidence of irritative symptoms and need for anticholinergics after catheter removal as well as urinary tract infection after 1 month were significantly higher in group A (P-value: 0.004 and 0.029, respectively) (Table).
DISCUSSION


To the authors knowledge, this is the first prospective controlled randomized study comparing short-term stenting with the classic 4 weeks stenting after laparoscopic pyeloplasty in the pediatric age group. In addition, the used technique of stenting not only allows stent removal on outpatient basis without anesthesia but also benefits from the pre-operative retrograde study so as not to miss any associated pathology in the ureter.
CONCLUSION


Short-term ureteric stenting after laparoscopic pyeloplasty in pediatric age group is safe and not inferior to the standard 4-week stenting. It also avoids the stent-related complications.",2020,Short-term ureteric stenting after laparoscopic pyeloplasty in pediatric age group is safe and not inferior to the standard 4-week stenting.,['37 children (less than 16 years-old) with pelvi-ureteric junction obstruction (PUJO) were managed by laparoscopic pyeloplasty by the same surgeon in the period between April 2015 and September 2017'],"['Short-term ureteric stenting', 'short-term stenting with the classic 4 weeks stenting after laparoscopic pyeloplasty', 'ureteric stents', 'laparoscopic pyeloplasty', 'pediatric laparoscopic pyeloplasty']","['operative duration, postoperative leakage, hospital stay, early postoperative complications', 'urinary tract infection', 'Urine culture and sensitivity', 'incidence of irritative symptoms']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0521619', 'cui_str': 'Pelvi-ureteric junction obstruction'}, {'cui': 'C0812509', 'cui_str': 'Laparoscopic pyeloplasty'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0041951', 'cui_str': 'Ureter'}, {'cui': 'C0439658', 'cui_str': 'Classic (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0812509', 'cui_str': 'Laparoscopic pyeloplasty'}, {'cui': 'C0183518', 'cui_str': 'Ureteric stent (physical object)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0430404', 'cui_str': 'Urine culture (procedure)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",37.0,0.0491849,Short-term ureteric stenting after laparoscopic pyeloplasty in pediatric age group is safe and not inferior to the standard 4-week stenting.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Abdelwahab', 'Affiliation': 'Urology Department, Faculty of Medicine, Cairo University, Egypt.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Abdelaziz', 'Affiliation': 'Urology Department, Faculty of Medicine, Cairo University, Egypt. Electronic address: drayehia81@gmail.com.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Aboulela', 'Affiliation': 'Urology Department, Faculty of Medicine, Cairo University, Egypt.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Shouman', 'Affiliation': 'Urology Department, Faculty of Medicine, Cairo University, Egypt.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Ghoneima', 'Affiliation': 'Urology Department, Faculty of Medicine, Cairo University, Egypt.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shoukry', 'Affiliation': 'Urology Department, Faculty of Medicine, Cairo University, Egypt.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kassem', 'Affiliation': 'Urology Department, Faculty of Medicine, Cairo University, Egypt.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Abdelhamid', 'Affiliation': 'Urology Department, Faculty of Medicine, Cairo University, Egypt.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Abdelhakim', 'Affiliation': 'Urology Department, Faculty of Medicine, Cairo University, Egypt.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'ElGhoneimy', 'Affiliation': 'Urology Department, Faculty of Medicine, Cairo University, Egypt.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Morsi', 'Affiliation': 'Urology Department, Faculty of Medicine, Cairo University, Egypt.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Badawy', 'Affiliation': 'Urology Department, Faculty of Medicine, Cairo University, Egypt.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Elkady', 'Affiliation': 'Urology Department, Faculty of Medicine, Cairo University, Egypt.'}]",Journal of pediatric urology,['10.1016/j.jpurol.2019.10.016']
233,30587521,Cerebral gustatory activation in response to free fatty acids using gustatory evoked potentials in humans.,"There is some evidence of specific oro-detection of FFAs in rodents and humans. The aim of this study was to record gustatory evoked potentials (GEPs) in response to FFA solutions and to compare GEPs in response to linoleic acid solution with GEPs obtained after stimulation with sweet and salty tastants. Eighteen healthy men were randomly stimulated with fatty (linoleic acid), sweet (sucrose), and salty (NaCl) solutions at two concentrations in the first experiment. Control recordings (n = 14) were obtained during stimulation by a paraffin oil mixture without FFA or by water. In the second experiment, 28 men were randomly stimulated with five FFA solutions and a paraffin emulsion. GEPs were recorded with electroencephalographic electrodes at Cz, Fz, and Pz. GEPs were observed in response to FFA in all participants. GEP characteristics did not differ according to the quality and the concentration of the solutions in the first experiment and according to the FFA in the second experiment. This study describes for the first time GEPs in response to FFA and demonstrates that the presence of FFA in the mouth triggers an activation of the gustatory cortex. These data reinforce the concept that fat taste could be the sixth primary taste.",2019,GEP characteristics did not differ according to the quality and the concentration of the solutions in the first experiment and according to the FFA in the second experiment.,"['Eighteen healthy men', 'humans', '28 men']","['fatty (linoleic acid), sweet (sucrose), and salty (NaCl) solutions', 'linoleic acid solution with GEPs obtained after stimulation with sweet and salty tastants', 'gustatory evoked potentials (GEPs', 'five FFA solutions and a paraffin emulsion', 'paraffin oil mixture without FFA or by water']",[],"[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0023750', 'cui_str': 'Linoleic Acids'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0439678', 'cui_str': 'Gustatory (qualifier value)'}, {'cui': 'C0015214', 'cui_str': 'Evoked Potentials'}, {'cui': 'C0030415', 'cui_str': 'Paraffin'}, {'cui': 'C0014020', 'cui_str': 'Emulsions'}, {'cui': 'C0070062', 'cui_str': 'paraffin oils'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}]",[],28.0,0.0235865,GEP characteristics did not differ according to the quality and the concentration of the solutions in the first experiment and according to the FFA in the second experiment.,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mouillot', 'Affiliation': ""Centre des Sciences du Goût et de l'Alimentation, AgroSup Dijon, CNRS, INRA, Université Bourgogne Franche-Comté, F-21000 Dijon, France.""}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Szleper', 'Affiliation': ""Centre des Sciences du Goût et de l'Alimentation, AgroSup Dijon, CNRS, INRA, Université Bourgogne Franche-Comté, F-21000 Dijon, France.""}, {'ForeName': 'Gaspard', 'Initials': 'G', 'LastName': 'Vagne', 'Affiliation': ""Centre des Sciences du Goût et de l'Alimentation, AgroSup Dijon, CNRS, INRA, Université Bourgogne Franche-Comté, F-21000 Dijon, France.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Barthet', 'Affiliation': ""Centre des Sciences du Goût et de l'Alimentation, AgroSup Dijon, CNRS, INRA, Université Bourgogne Franche-Comté, F-21000 Dijon, France.""}, {'ForeName': 'Djihed', 'Initials': 'D', 'LastName': 'Litime', 'Affiliation': ""Centre des Sciences du Goût et de l'Alimentation, AgroSup Dijon, CNRS, INRA, Université Bourgogne Franche-Comté, F-21000 Dijon, France.""}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Brindisi', 'Affiliation': ""Centre des Sciences du Goût et de l'Alimentation, AgroSup Dijon, CNRS, INRA, Université Bourgogne Franche-Comté, F-21000 Dijon, France.""}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Leloup', 'Affiliation': ""Centre des Sciences du Goût et de l'Alimentation, AgroSup Dijon, CNRS, INRA, Université Bourgogne Franche-Comté, F-21000 Dijon, France.""}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Penicaud', 'Affiliation': ""Centre des Sciences du Goût et de l'Alimentation, AgroSup Dijon, CNRS, INRA, Université Bourgogne Franche-Comté, F-21000 Dijon, France.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Nicklaus', 'Affiliation': ""Centre des Sciences du Goût et de l'Alimentation, AgroSup Dijon, CNRS, INRA, Université Bourgogne Franche-Comté, F-21000 Dijon, France.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Brondel', 'Affiliation': ""Centre des Sciences du Goût et de l'Alimentation, AgroSup Dijon, CNRS, INRA, Université Bourgogne Franche-Comté, F-21000 Dijon, France.""}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Jacquin-Piques', 'Affiliation': ""Centre des Sciences du Goût et de l'Alimentation, AgroSup Dijon, CNRS, INRA, Université Bourgogne Franche-Comté, F-21000 Dijon, France agnes.jacquin-piques@chu-dijon.fr.""}]",Journal of lipid research,['10.1194/jlr.M086587']
234,32331244,Dietary Intervention in Pregnant Women with Gestational Diabetes; Protocol for the DiGest Randomised Controlled Trial.,"Gestational diabetes mellitus (GDM) annually affects 35,000 pregnancies in the United Kingdom, causing suboptimal health outcomes to the mother and child. Obesity and excessive gestational weight gain are risk factors for GDM. The Institute of Medicine recommends weight targets for women that are overweight and obese, however, there are no clear guidelines for women with GDM. Observational data suggest that modest weight loss (0.6-2 kg) after 28 weeks may reduce risk of caesarean section, large-for-gestational-age (LGA), and maternal postnatal glycaemia. This protocol for a multicentre randomised double-blind controlled trial aims to identify if a fully controlled reduced energy diet in GDM pregnancy improves infant birthweight and reduces maternal weight gain (primary outcomes). A total of 500 women with GDM (National Institute of Health and Care Excellence (NICE) 2015 criteria) and body mass index (BMI) ≥25 kg/m 2  will be randomised to receive a standard (2000 kcal/day) or reduced energy (1200 kcal/day) diet box containing all meals and snacks from 28 weeks to delivery. Women and caregivers will be blinded to the allocations. Food diaries, continuous glucose monitoring, and anthropometry will measure dietary compliance, glucose levels, and weight changes. Women will receive standard antenatal GDM management (insulin/metformin) according to NICE guidelines. The secondary endpoints include caesarean section rates, LGA, and maternal postnatal glucose concentrations.",2020,This protocol for a multicentre randomised double-blind controlled trial aims to identify if a fully controlled reduced energy diet in GDM pregnancy improves infant birthweight and reduces maternal weight gain (primary outcomes).,"['women with GDM', 'Pregnant Women with Gestational Diabetes', '500 women with GDM (National Institute of Health and Care Excellence (NICE) 2015 criteria) and body mass index (BMI) ≥25 kg/m 2', 'Gestational diabetes mellitus (GDM) annually affects 35,000 pregnancies in the United Kingdom, causing suboptimal health outcomes to the mother and child']","['Dietary Intervention', 'standard (2000 kcal/day) or reduced energy (1200 kcal/day) diet box containing all meals and snacks from 28 weeks to delivery', 'standard antenatal GDM management (insulin/metformin']","['weight loss', 'Food diaries, continuous glucose monitoring, and anthropometry will measure dietary compliance, glucose levels, and weight changes', 'caesarean section rates, LGA, and maternal postnatal glucose concentrations', 'risk of caesarean section, large-for-gestational-age (LGA), and maternal postnatal glycaemia', 'Obesity and excessive gestational weight gain', 'maternal weight gain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0456649', 'cui_str': 'kcal/day'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0012157', 'cui_str': 'Dietary Records'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C1848395', 'cui_str': 'Large for dates baby'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}]",500.0,0.204451,This protocol for a multicentre randomised double-blind controlled trial aims to identify if a fully controlled reduced energy diet in GDM pregnancy improves infant birthweight and reduces maternal weight gain (primary outcomes).,"[{'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Kusinski', 'Affiliation': 'Institute of Metabolic Science, University of Cambridge, Cambridge CB2 0QQ, UK.'}, {'ForeName': 'Helen R', 'Initials': 'HR', 'LastName': 'Murphy', 'Affiliation': 'Cambridge Universities NHS Foundation Trust, Cambridge CB2 0QQ, UK.'}, {'ForeName': 'Emanuella', 'Initials': 'E', 'LastName': 'De Lucia Rolfe', 'Affiliation': 'NIHR Cambridge Biomedical Research Centre-Diet, Anthropometry and Physical Activity Group, MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge, Cambridge CB2 0QQ, UK.'}, {'ForeName': 'Kirsten L', 'Initials': 'KL', 'LastName': 'Rennie', 'Affiliation': 'NIHR Cambridge Biomedical Research Centre-Diet, Anthropometry and Physical Activity Group, MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge, Cambridge CB2 0QQ, UK.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Oude Griep', 'Affiliation': 'NIHR Cambridge Biomedical Research Centre-Diet, Anthropometry and Physical Activity Group, MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge, Cambridge CB2 0QQ, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Hughes', 'Affiliation': 'Institute of Metabolic Science, University of Cambridge, Cambridge CB2 0QQ, UK.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Taylor', 'Affiliation': 'Institute of Cellular Medicine, University of Newcastle, Cambridge NE4 5PL, UK.'}, {'ForeName': 'Claire L', 'Initials': 'CL', 'LastName': 'Meek', 'Affiliation': 'Institute of Metabolic Science, University of Cambridge, Cambridge CB2 0QQ, UK.'}]",Nutrients,['10.3390/nu12041165']
235,32120028,Phase I randomized trial of liothyronine for remyelination in multiple sclerosis: A dose-ranging study with assessment of reliability of visual outcomes.,"BACKGROUND


Thyroid hormone promotes remyelination in multiple sclerosis (MS) animal models through a variety of mechanisms. Liothyronine (L-T3) is a short-acting thyroid hormone with demonstrated safety and tolerability for short-term and chronic use in euthyroid adults with other health conditions, but has not been studied in people with MS. The objectives of this single-center, phase I, placebo-controlled, clinical trial were to determine the safety, tolerability, and optimal dosing of L-T3 in people with MS in preparation for a phase 2 remyelination clinical trial. Secondary goals included exploration of the reliability of functional and clinical measurements of myelination in the anterior visual pathway over one week.
METHODS


Groups of six clinically stable people with MS were randomized in a 4:2 ratio to receive L-T3 or placebo. The first group received 50 mcg total daily dose (TDD) of L-T3, with escalating doses of L-T3 in subsequent groups, up to potentially 150 mcg TDD in the final group. Prior to enrollment for the next dose-escalated group, all safety measures for the prior dose were reviewed. The maximum tolerated dose (MTD) was considered to be the dose below which two or more participants experienced dose limiting symptoms or one participant experienced a serious adverse event. After the MTD was reached, no further patients were enrolled. Visual evoked potentials (VEP) P100 latency with two different check sizes (17' and 34') and Sloan low contrast letter acuity (LCLA) were measured pre- and post-treatment. To determine whether there was a treatment effect, the placebo and L-T3 groups were compared using a clustered bootstrap regression estimation. A linear mixed effects model was used to determine test-retest reliability of VEP and LCLA in all eyes.
RESULTS


Between May 2016 and November 2016, 15 people with MS were randomized to L-T3 (n = 10) or placebo (n = 5). Subjects were adherent to the study drug and the MTD was 75 mcg TDD. No serious adverse events were observed and the most common adverse events were poor sleep and loose stools. No treatment effect of L-T3 was observed over one week. Therefore, data from patients on L-T3 and placebo were pooled to explore VEP and LCLA reliability. The intraclass correlations of VEP 17', VEP 34' and LCLA were 0.836, 0.860, and 0.932, respectively. The mean differences in values between visits 1 and 2 for VEP 17' and 34' and LCLA were 1.9 ms/eye (SD 6.5), 0.4 ms/eye (6.3), and 0.8/eye (3.6), respectively.
CONCLUSIONS


This study confirms the short-term safety and tolerability of L-T3 in people with MS, with 75 mcg TDD as the MTD. Our results also support that, despite small variations over one week, VEP with various check sizes and Sloan LCLA are reliable functional and clinical outcome measures that could be used in remyelination clinical trials in MS. A future phase 2 clinical trial to investigate the efficacy of L-T3 as a remyelination therapy may be warranted. This trial was registered on clinicaltrials.gov (NCT02760056).",2020,"The intraclass correlations of VEP 17', VEP 34' and LCLA were 0.836, 0.860, and 0.932, respectively.","['euthyroid adults with other health conditions', 'Groups of six clinically stable people with MS', 'people with MS in preparation for a phase 2 remyelination clinical trial', 'Between May 2016 and November 2016, 15 people with MS', 'people with MS, with 75 mcg TDD as the MTD', 'multiple sclerosis']","['Liothyronine (L-T3', '50 mcg total daily dose (TDD) of L-T3', 'L-T3', 'placebo', 'liothyronine', 'L-T3 or placebo']","['serious adverse events', 'Sloan low contrast letter acuity (LCLA', 'exploration of the reliability of functional and clinical measurements of myelination in the anterior visual pathway over one week', 'serious adverse event', 'Visual evoked potentials (VEP) P100 latency', 'VEP and LCLA reliability', 'safety and tolerability', 'maximum tolerated dose (MTD', 'safety, tolerability']","[{'cui': 'C0117002', 'cui_str': 'Euthyroid (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0334220', 'cui_str': 'Remyelination'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C0183841', 'cui_str': 'Telecommunications Devices for the Deaf'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}]","[{'cui': 'C0041014', 'cui_str': 'liothyronine'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C1280903', 'cui_str': 'Exploration procedure'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0042829', 'cui_str': 'Visual Pathways'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0546834', 'cui_str': 'Visual evoked potential study'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0752079', 'cui_str': 'Maximally Tolerated Dose'}]",15.0,0.117628,"The intraclass correlations of VEP 17', VEP 34' and LCLA were 0.836, 0.860, and 0.932, respectively.","[{'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Wooliscroft', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, 3181 S.W. Sam Jackson Park Road, Portland, OR L226 97239, United States; Department of Neurology, Department of Veterans Affairs Portland Health Care System, 3710 S.W. U.S. Veterans Hospital Rd., Portland, OR 97239, United States. Electronic address: wooliscr@ohsu.edu.'}, {'ForeName': 'Ghadah', 'Initials': 'G', 'LastName': 'Altowaijri', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, 3181 S.W. Sam Jackson Park Road, Portland, OR L226 97239, United States; Department of Neurology, Department of Veterans Affairs Portland Health Care System, 3710 S.W. U.S. Veterans Hospital Rd., Portland, OR 97239, United States.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Hildebrand', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, 3181 S.W. Sam Jackson Park Road, Portland, OR L226 97239, United States; Department of Neurology, Department of Veterans Affairs Portland Health Care System, 3710 S.W. U.S. Veterans Hospital Rd., Portland, OR 97239, United States. Electronic address: hildeand@ohsu.edu.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Samuels', 'Affiliation': 'Division of Endocrinology, Diabetes and Clinical Nutrition, Oregon Health & Science University, 3181 S.W. Sam Jackson Park Road, CR107, Portland, OR 97239, United States. Electronic address: samuelsm@ohsu.edu.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Oken', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, 3181 S.W. Sam Jackson Park Road, Portland, OR L226 97239, United States. Electronic address: oken@ohsu.edu.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Bourdette', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, 3181 S.W. Sam Jackson Park Road, Portland, OR L226 97239, United States. Electronic address: bourdett@ohsu.edu.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Cameron', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, 3181 S.W. Sam Jackson Park Road, Portland, OR L226 97239, United States; Department of Neurology, Department of Veterans Affairs Portland Health Care System, 3710 S.W. U.S. Veterans Hospital Rd., Portland, OR 97239, United States. Electronic address: cameromi@ohsu.edu.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102015']
236,32162727,Promoting and maintaining urinary continence: Follow-up from a cluster-randomized trial of elderly village women in Bangladesh.,"AIMS


Pelvic floor and mobility exercises were shown to be effective in managing incontinence in a cluster-randomized trial (CRT) of village women aged 60 to 75 years in Bangladesh. The present analysis examines continence 12 months after the CRT and exercise program implementation with village paramedics as preceptors.
METHODS


Women from nine villages in the exercise arm of the CRT were followed-up 12 months after the 6-month intervention. They provided information about exercise since the CRT and a 3-day continence record (3DCR). Posttrial, a further 6-month exercise intervention led by village paramedics was initiated in 20 villages. Women completed the two-item Sandvik severity questionnaire before and after the intervention. Paramedics kept a record of each woman's attendance at the 48 exercise sessions RESULTS: A total of 130 of 150 women from the CRT completed the 12-month follow-up; 61.5% were dry on the 3DCR at follow-up. Total continence was related to the continuation of exercises carried out in the home and absence of urinary tract infection at follow-up. Those exercising at follow-up had an odds ratio (OR) of 3.49 (95% confidence interval [CI], 1.86-6.58) of being continent at follow-up. Higher end-of-CRT body mass index was associated with greater follow-up leakage. In the 20-village roll-out, with 316 incontinent women, improvement in both severity and total continence on the Sandvik questionnaire were related to a total number of sessions attended (OR = 1.09; 95% CI, 1.05-1.13). At roll-out, 38.6% achieved continence, comparable to 43.0% in the CRT using physiotherapy preceptors CONCLUSIONS: Group exercise classes led by paramedics resulted in a marked improvement in continence but maintenance requires exercise postintervention.",2020,Total continence was related to the continuation of exercises carried out in the home and absence of urinary tract infection at follow-up.,"['A total of 130 of 150 women from the CRT completed the 12-month follow-up; 61.5% were dry on the 3DCR at follow-up', 'Women from nine villages in the exercise arm of the CRT were followed-up 12 months after the 6-month intervention', '316 incontinent women', 'elderly village women in Bangladesh', 'village women aged 60 to 75 years in Bangladesh']","['Pelvic floor and mobility exercises', 'CRT']","['continence but maintenance requires exercise postintervention', 'severity and total continence on the Sandvik questionnaire', 'Total continence']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0231238', 'cui_str': 'Incontinent (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",316.0,0.0528876,Total continence was related to the continuation of exercises carried out in the home and absence of urinary tract infection at follow-up.,"[{'ForeName': 'Rezaul', 'Initials': 'R', 'LastName': 'Haque', 'Affiliation': 'Gonoshasthaya Kendra, Savar, Bangladesh.'}, {'ForeName': 'Fardous', 'Initials': 'F', 'LastName': 'Kabir', 'Affiliation': 'Gonoshasthaya Kendra, Savar, Bangladesh.'}, {'ForeName': 'Kamrun', 'Initials': 'K', 'LastName': 'Naher', 'Affiliation': 'Department of Physiotherapy, Gono Bishwabidyalay University, Savar, Bangladesh.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Cherry', 'Affiliation': 'Division of Preventive Medicine, Department of Medicine, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Dianna', 'Initials': 'D', 'LastName': 'MacDonald', 'Affiliation': 'Department of Obstetrics and Gynaecology, Lois Hole Hospital for Women, Edmonton, Canada.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Wagg', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Zafrullah', 'Initials': 'Z', 'LastName': 'Chowdhury', 'Affiliation': 'Gonoshasthaya Kendra, Savar, Bangladesh.'}]",Neurourology and urodynamics,['10.1002/nau.24334']
237,32088652,Comparison of MS inflammatory activity in women using continuous versus cyclic combined oral contraceptives.,"BACKGROUND


Many women with multiple sclerosis (MS) report fluctuating symptoms across their menstrual cycle. Oral contraceptives (OCs) alter hormonal levels across the menstrual cycle. While cyclic OCs administer hormones for 21 days, followed by a week of placebo, continuous OCs can administer continuous doses of hormones for up to 3 months. Previous studies have suggested that OC use is associated with lower MS-related inflammation. We hypothesized that due to reduced hormonal fluctuations, women with MS might experience less inflammatory activity (clinical relapses+MRI) on continuous OCs than on cyclic OCs.
METHODS


We performed a retrospective analysis of prospectively collected data. For women with MS aged 18-50 seen at the UCSF Center for MS and Neuroinflammation, we extracted data on OC use from the Electronic Medical Records (EMR). All variables were confirmed using manual clinical chart review. We identified 19 women with relapsing forms of MS on continuous OCs and matched them (2:1 when possible) to women on cyclic OCs for OC formulation, age, MS duration and DMT type. Inflammatory activity in the two groups was then compared using log-rank tests (time to new relapse, new T2-weighted lesion formation, and gadolinium-enhancing lesion formation) and t-tests (annualized relapse rate). We also performed subgroup analyses in women with at least 1 year (N = 28) and 2 years (N = 21) of clinical observation. A power calculation was performed.
RESULTS


There was no difference in time to relapse (p = 0.50) between continuous and cycling OC users. However, continuous OC users showed a statistical trend to longer time to T2 lesion formation (p = 0.09) and longer time to contrast-enhancing lesion formation (p = 0.05). In patients with at least 1 year of observation, there was a significant difference in time to T2 lesion formation (p = 0.03) and time to contrast-enhancing lesion formation (p = 0.02).
CONCLUSION


In this exploratory study, women on continuous OCs showed a trend towards less inflammatory activity on MRI relative to women on cyclic OCs. This difference was not reflected in relapse rates. We estimate that 342 patients would be required for an adequately powered cohort study to evaluate such an effect. Our findings provide reassurance that for women using continuous OCs to alleviate menstrual fluctuations in symptoms, there is not an increase in MS-related inflammatory activity.",2020,"However, continuous OC users showed a statistical trend to longer time to T2 lesion formation (p = 0.09) and longer time to contrast-enhancing lesion formation (p = 0.05).","['19 women with relapsing forms of MS on continuous OCs and matched them (2:1 when possible) to women on cyclic OCs for OC formulation, age, MS duration and DMT type', 'women with at least 1 year (N\u202f=\u202f28) and 2 years (N\u202f=\u202f21) of clinical observation', '342 patients', 'For women with MS aged 18-50 seen at the UCSF Center for MS and Neuroinflammation', 'women using continuous versus cyclic combined oral contraceptives']","['Oral contraceptives (OCs', 'placebo, continuous OCs']","['MS inflammatory activity', 'time to relapse', 'time to contrast-enhancing lesion formation', 'Inflammatory activity', 'relapse rates', 'longer time to contrast-enhancing lesion formation', 'longer time to T2 lesion formation', 'time to T2 lesion formation']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1720477', 'cui_str': 'When'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0439596', 'cui_str': 'Cyclic (qualifier value)'}, {'cui': 'C0009906', 'cui_str': 'Contraceptive Agents, Female, Combined'}]","[{'cui': 'C0029151', 'cui_str': 'Oral contraception (finding)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",342.0,0.070475,"However, continuous OC users showed a statistical trend to longer time to T2 lesion formation (p = 0.09) and longer time to contrast-enhancing lesion formation (p = 0.05).","[{'ForeName': 'Chelsea S', 'Initials': 'CS', 'LastName': 'Chen', 'Affiliation': 'Weill Institute for the Neurosciences, Department of Neurology, University of California, San Francisco, CA, United States. Electronic address: chelsea.chen@ucsf.edu.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Krishnakumar', 'Affiliation': 'Weill Institute for the Neurosciences, Department of Neurology, University of California, San Francisco, CA, United States. Electronic address: tanya.krishnakumar@ucsf.edu.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Rowles', 'Affiliation': 'Weill Institute for the Neurosciences, Department of Neurology, University of California, San Francisco, CA, United States. Electronic address: william.rowles@ucsf.edu.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Anderson', 'Affiliation': 'Weill Institute for the Neurosciences, Department of Neurology, University of California, San Francisco, CA, United States. Electronic address: annika.anderson@ucsf.edu.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'Weill Institute for the Neurosciences, Department of Neurology, University of California, San Francisco, CA, United States. Electronic address: chao.zhao@ucsf.edu.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Do', 'Affiliation': 'Weill Institute for the Neurosciences, Department of Neurology, University of California, San Francisco, CA, United States. Electronic address: lvtieu@gmail.com.'}, {'ForeName': 'Riley', 'Initials': 'R', 'LastName': 'Bove', 'Affiliation': 'Weill Institute for the Neurosciences, Department of Neurology, University of California, San Francisco, CA, United States. Electronic address: riley.bove@ucsf.edu.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.101970']
238,32322552,A comparison of cardiopulmonary resuscitation with standard manual compressions versus compressions with real-time audiovisual feedback: A randomized controlled pilot study.,"Background


Strategies that improve cardiopulmonary resuscitation (CPR) guideline adherence may improve in-hospital cardiac arrest (IHCA) outcomes. Real-time audiovisual feedback (AVF) is one strategy identified by the American Heart Association and the International Liaison Committee on Resuscitation as an area needing further investigation. The aim of this study was to determine if in patients with IHCA, does the addition of a free-standing AVF device to standard manual chest compressions during CPR improve sustained return of spontaneous circulation (ROSC) rates (primary outcome) or CPR quality or guideline adherence (secondary outcomes).
Methods


This was a prospective, randomized, controlled, parallel study of patients undergoing resuscitation with chest compressions for IHCA in the mixed medical-surgical intensive care units (ICUs) of two academic teaching hospitals. Patients were randomized to receive either standard manual chest compressions or compressions using the Cardio First Angel™ feedback device.
Results


Sixty-seven individuals were randomized, and 22 were included. CPR quality evaluation and guideline adherence scores were improved in the intervention group ( P  = 0.0005 for both). The incidence of ROSC was similar between groups ( P  = 0.64), as was survival to ICU discharge ( P  = 0.088) and survival to hospital discharge ( P  = 0.095).
Conclusion


The use of the Cardio First Angel™ compression feedback device improved adherence to publish CPR guidelines and CPR quality. The insignificant change in rates of ROSC and survival to ICU or hospital discharge may have been related to small sample size. Further clinical studies comparing AVF devices to standard manual compressions are needed, as are device head-to-head comparisons.",2020,CPR quality evaluation and guideline adherence scores were improved in the intervention group ( P  = 0.0005 for both).,"['patients with IHCA', 'Sixty-seven individuals were randomized, and 22 were included', 'patients undergoing resuscitation with chest compressions for IHCA in the mixed medical-surgical intensive care units (ICUs) of two academic teaching hospitals']","['standard manual chest compressions or compressions using the Cardio First Angel™ feedback device', 'Real-time audiovisual feedback (AVF', 'cardiopulmonary resuscitation with standard manual compressions versus compressions with real-time audiovisual feedback']","['spontaneous circulation (ROSC) rates (primary outcome) or CPR quality or guideline adherence (secondary outcomes', 'survival to ICU discharge', 'CPR quality evaluation and guideline adherence scores', 'rates of ROSC and survival', 'survival to hospital discharge', 'incidence of ROSC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1690590', 'cui_str': 'Surgical intensive care unit'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}]","[{'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0525059', 'cui_str': 'Guideline Adherence'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",67.0,0.0943899,CPR quality evaluation and guideline adherence scores were improved in the intervention group ( P  = 0.0005 for both).,"[{'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Vahedian-Azimi', 'Affiliation': 'Trauma Research Center, Nursing Faculty, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farshid', 'Initials': 'F', 'LastName': 'Rahimibashar', 'Affiliation': 'Department of Anesthesia and Critical Care, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Miller', 'Affiliation': 'Department of Emergency Medicine, East Carolina University Brody School of Medicine, Greenville, NC, USA.'}]",International journal of critical illness and injury science,['10.4103/IJCIIS.IJCIIS_84_19']
239,32311960,Traditional Chinese medicine (Liang-Xue-Di-Huang Decoction) for hemorrhoid hemorrhage: Study Protocol Clinical Trial (SPIRIT Compliant).,"BACKGROUND


Hemorrhoidal disease (HD) is one of the commonest proctologic condition in the general population. Medical therapy for HD has not been formally confirmed due to the inconsistent of results. Liang-Xue-Di-Huang Decoction, a kind of ancient Chinese classical prescription, has been used to treat HD from the 19th century in China. However, clinical research of Liang-Xue-Di-Huang Decoction in the treatment of HD was lack. We designed this study to evaluate the efficacy and safety of Liang-Xue-Di-Huang Decoction in the treatment of HD.
METHODS/DESIGN


A randomized, controlled, double blind, double-mimetic agent, and multicenter trial to evaluate the efficacy and safety of Liang-Xue-Di-Huang Decoction is proposed. HD patients (stage I, II, III) will be randomly assigned into experimental group or control group. HD patients will receive a 7-day treatments and a 7-day follow-up. The primary outcome measure is the Hemorrhoid Bleeding Score in 7 and 14 days. The Secondary outcome measures are Goligher prolapse score and quality-of-life score in 7 and 14 days.
DISCUSSION


This study will provide objective evidences to evaluate the efficacy and safety of Liang-Xue-Di-Huang Decoction in treatment of HD.",2020,"The Secondary outcome measures are Goligher prolapse score and quality-of-life score in 7 and 14 days.
","['HD patients (stage I, II, III', 'hemorrhoid hemorrhage']","['Traditional Chinese medicine (Liang-Xue-Di-Huang Decoction', 'Liang-Xue-Di-Huang Decoction']","['Hemorrhoid Bleeding Score', 'efficacy and safety', 'Goligher prolapse score and quality-of-life score']","[{'cui': 'C0034896', 'cui_str': 'Rectum structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0019112', 'cui_str': 'Hemorrhoids'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}]","[{'cui': 'C0265031', 'cui_str': 'Bleeding hemorrhoids'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0610441,"The Secondary outcome measures are Goligher prolapse score and quality-of-life score in 7 and 14 days.
","[{'ForeName': 'Shuo-Yang', 'Initials': 'SY', 'LastName': 'Shi', 'Affiliation': 'Nanjing University of Chinese Medicine, Changzhou Hospital of Traditional Chinese Medicine, Changzhou.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing.'}, {'ForeName': 'Zong-Qi', 'Initials': 'ZQ', 'LastName': 'He', 'Affiliation': 'Suzhou Hospital of Traditional Chinese Medicine, Suzhou.'}, {'ForeName': 'Zhao-Feng', 'Initials': 'ZF', 'LastName': 'Shen', 'Affiliation': 'Nanjing University of Chinese Medicine, Changzhou Hospital of Traditional Chinese Medicine, Changzhou.'}, {'ForeName': 'Wei-Xin', 'Initials': 'WX', 'LastName': 'Zhang', 'Affiliation': 'Nanjing University of Chinese Medicine, Changzhou Hospital of Traditional Chinese Medicine, Changzhou.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Nanjing University of Chinese Medicine, Changzhou Hospital of Traditional Chinese Medicine, Changzhou.'}, {'ForeName': 'Cheng-Biao', 'Initials': 'CB', 'LastName': 'Xu', 'Affiliation': 'Xuyi Hospital of Traditional Chinese Medicine, Huaian.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Geng', 'Affiliation': 'Wujin Hospital of Traditional Chinese Medicine, Changzhou, Jiangsu, China.'}, {'ForeName': 'Ben-Sheng', 'Initials': 'BS', 'LastName': 'Wu', 'Affiliation': 'Suzhou Hospital of Traditional Chinese Medicine, Suzhou.'}, {'ForeName': 'Yu-Gen', 'Initials': 'YG', 'LastName': 'Chen', 'Affiliation': 'Nanjing University of Chinese Medicine, Changzhou Hospital of Traditional Chinese Medicine, Changzhou.'}]",Medicine,['10.1097/MD.0000000000019720']
240,32311961,Efficacy and safety of combination of curcuminoid complex and diclofenac versus diclofenac in knee osteoarthritis: A randomized trial.,"BACKGROUND


To compare the efficacy and safety of combination of curcuminoid complex and diclofenac vs diclofenac alone in the treatment of knee osteoarthritis (OA).
METHODS


In this randomized trial, 140 patients of knee OA received either curcuminoid complex 500 mg (BCM-95) with diclofenac 50 mg 2 times daily or diclofenac 50 mg alone 2 times daily for 28 days. Patients were assessed at baseline, day 14 and day 28. Primary efficacy measures were Knee injury and OA outcome score (KOOS) subscale at day 14 and day 28. Anti-ulcer effect and patient-physician's global assessment of therapy at day 28 were included as secondary endpoints. Safety after treatment was evaluated by recording adverse events and laboratory investigations.
RESULTS


Both treatment groups showed improvement in primary endpoints at each evaluation visit. Patients receiving curcuminoid complex plus diclofenac showed significantly superior improvement in KOOS subscales, viz. pain and quality of life at each study visit (P < .001) when compared to diclofenac. Less number of patients required rescue analgesics in curcuminoid complex plus diclofenac group (3%) compared to diclofenac group (17%). The number of patients who required histamine 2 (H2) blockers was significantly less in curcuminoid complex plus diclofenac group compared to diclofenac group (6% vs 28%, respectively; P < .001). Adverse effects were significantly less in curcuminoid complex plus diclofenac group (13% vs 38% in diclofenac group; P < .001). Patient's and physician's global assessment of therapy favored curcuminoid complex plus diclofenac than diclofenac.
CONCLUSION


Combination of curcuminoid complex and diclofenac showed a greater improvement in pain and functional capacity with better tolerability and could be a better alternative treatment option in symptomatic management of knee OA.
TRIAL REGISTRATION


ISRCTN, ISRCTN10074826.",2020,Adverse effects were significantly less in curcuminoid complex plus diclofenac group (,"['knee osteoarthritis', 'knee osteoarthritis (OA', '140 patients of knee OA']","['diclofenac', 'curcuminoid complex and diclofenac', 'curcuminoid complex 500\u200amg (BCM-95) with diclofenac 50\u200amg 2 times daily or diclofenac', 'curcuminoid complex plus diclofenac', 'curcuminoid complex and diclofenac vs diclofenac']","['number of patients who required histamine 2 (H2) blockers', 'Efficacy and safety', 'Knee injury and OA outcome score (KOOS) subscale', 'KOOS subscales', 'pain and quality of life', 'Adverse effects', 'pain and functional capacity']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0065839', 'cui_str': 'Carbendazim'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019588', 'cui_str': 'Histamine'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0022744', 'cui_str': 'Injury of knee'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}]",140.0,0.0559604,Adverse effects were significantly less in curcuminoid complex plus diclofenac group (,"[{'ForeName': 'Dhaneshwar', 'Initials': 'D', 'LastName': 'Shep', 'Affiliation': 'Department of Pharmacology, Krishna Institute of Medical Sciences, Satara.'}, {'ForeName': 'Chitra', 'Initials': 'C', 'LastName': 'Khanwelkar', 'Affiliation': 'Department of Pharmacology, Krishna Institute of Medical Sciences, Satara.'}, {'ForeName': 'Prakashchandra', 'Initials': 'P', 'LastName': 'Gade', 'Affiliation': ""Department of Pharmacology, Dr. Vithalrao Vikhe Patil Foundation's Medical College & Hospital, Ahmednagar.""}, {'ForeName': 'Satyanand', 'Initials': 'S', 'LastName': 'Karad', 'Affiliation': 'Department of Orthopedics, City Care Accident Hospital, Parli Vaijnath, Beed, Maharashtra, India.'}]",Medicine,['10.1097/MD.0000000000019723']
241,32311983,Effect of lower esophageal gastric tube implantation in postoperative enteral nutritional support in patients with laryngeal cancer: A study protocol for a randomized controlled trial.,"BACKGROUND


For a long time, postoperative nutritional support for laryngeal cancer patients has depended on the gastric tube for enteral nutrition. Silica gel gastric tube is often used in clinical practice; however, the gastric tube placed in the conventional depth often leads to various complications in the stomach, thus damaging the nutritional status of patients and leading to the poor prognosis.
METHODS/DESIGN


A total of 80 patients with laryngeal cancer in otolaryngology, head and neck surgery department of Deyang people's hospital from May 2020 to April 2022 will be selected and randomly divided into control group and experimental group according to the numerical table. Patients in the control group will receive conventional gastric tube placement, with a depth of 45 to 55 cm, which can extract gastric juice. B-ultrasound accurately positioned the gastric tube in the stomach instead of the cardia, and postoperative nasal feeding nutrition will be provided. In the experimental group, the gastric tube will be pulled out 10 cm after conventional placement and no gastric juice will be extracted. B-ultrasonography verified that the gastric tube will be located below the esophagus or above the cardia, and routine nasal feeding will be performed postoperatively. Analysis for comfort and prognosis were performed by general comfort questionnaire and various index including height, body mass index, albumin value, electrolyte, wound healing, pharyngeal fistula.
DISCUSSION


In this study, visual simulation scale and general comfort questionnaire developed by Kolaba, an American comfort nursing specialist, were used to evaluate the comfort level of the 2 groups of patients, including pain, acid reflux, upper abdominal burning sensation, and hiccup. Objective indexes such as height, body mass index, albumin value, electrolyte, wound healing, and pharyngeal fistula were used to evaluate the prognosis of the 2 groups of patients. The visual simulation scale can preliminarily judge the subjective feelings of patients.
TRIAL REGISTRATION


It has been registered at http://www.chictr.org.cn/listbycreater.aspx (Identifier: ChiCTR2000030378), Registered February 29, 2020.",2020,"The visual simulation scale can preliminarily judge the subjective feelings of patients.
","['patients with laryngeal cancer', 'laryngeal cancer patients', ""80 patients with laryngeal cancer in otolaryngology, head and neck surgery department of Deyang people's hospital from May 2020 to April 2022""]","['lower esophageal gastric tube implantation', 'conventional gastric tube placement']","['general comfort questionnaire and various index including height, body mass index, albumin value, electrolyte, wound healing, pharyngeal fistula', 'height, body mass index, albumin value, electrolyte, wound healing, and pharyngeal fistula']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007107', 'cui_str': 'Malignant tumor of larynx'}, {'cui': 'C0029892', 'cui_str': 'Otolaryngology'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1536454', 'cui_str': 'Pharyngeal fistula'}]",80.0,0.0256279,"The visual simulation scale can preliminarily judge the subjective feelings of patients.
","[{'ForeName': 'Hongying', 'Initials': 'H', 'LastName': 'Xiao', 'Affiliation': ""Department of Otolaryngology, Head and Neck Surgery, People's Hospital of De Yang City, Deyang City, Sichuan, China.""}, {'ForeName': 'Jianmin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Sisi', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Xiaofang', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000019771']
242,32311968,Effect of 5 different cervical collars on optic nerve sheath diameter: A randomized crossover trial.,"BACKGROUND


There is considerable evidence that prolonged use of cervical collars potentially cause detrimental effects including increase in optic nerve sheath diameter (ONSD) among healthy volunteers. Different types of cervical collars immobilize cervical spine variably well and may presumably differently influence the venous compression and hence the intracranial pressure. We therefore aimed to evaluate the influence of cervical spine immobilization with 5 different types of cervical collars on ONSD measured noninvasively by ultrasound on healthy volunteers.
METHODS


We conducted a randomized crossover trial including 60 adult healthy volunteers. Control assessment of the optic nerve sheath thickness was performed in both sagittal and transverse planes. Patient was placed supine on a transport stretcher, cervical collar was placed, and ONSD measurement was performed after 5 and 20 minutes. During the next days, the procedure was repeated with random allocation of participants and random cervical collar.
RESULTS


Sixty healthy volunteers were included in our study. ONSD left diameter [mm] for the baseline was 3.8 [interquartile range (IQR): 3.65-3.93)] mm. Using AMBU after 5 min, ONSD was changed up to 4.505 (IQR 4.285-4.61; P < .001) mm. The largest change at 5 minutes and 20 minutes was using Philly 4.73 (IQR: 4.49-4.895; P < .001) and 4.925 (IQR: 4.65-5.06; P < .001), respectively. Necklite reported the lower change in ONSD: 3.92 (IQR: 3.795-4; P = 1.0) mm in 5 minutes and 3.995 (IQR: 3.875 - 4.1; P = 1.0) mm in 20 minutes. ONSD right diameter [mm] for the baseline was 3.8 (IQR 3.675-3.9) mm. Using AMBU after 5 minutes, ONSD was changed up to 4.5 (IQR 4.21-4.6) mm. The largest change at 5 minutes and 20 minutes was using Philly 4.705 (IQR 4.455-4.9) and 4.93 (IQR 4.645-5.075), respectively. Necklite reported the lower change in ONSD -33.9 (IQR 3.795-3.99) mm in 5 minutes and 3.995 (IQR 3.86-4.09) mm in 20 minutes.
CONCLUSION


We report significant increase of ONSD from the baseline after cervical collar placement among healthy volunteers at 5 minutes and 20 minutes interval. In addition, no significant difference was noted between ONSD measurements at 5 and 20 minutes. Clinicians should take proactive steps to assess the actual need of cervical collar case by case basis. Nonetheless, when needed, Necklite moldable neck brace seems to be a reasonable option.Registration: ClinicalTrials database (www.clinicaltrials.gov, NCT03609879).",2020,"The largest change at 5 minutes and 20 minutes was using Philly 4.73 (IQR: 4.49-4.895; P < .001) and 4.925 (IQR: 4.65-5.06; P < .001), respectively.","['healthy volunteers', 'Registration', '60 adult healthy volunteers', 'Sixty healthy volunteers']",['5 different cervical collars'],"['ONSD measurements', 'optic nerve sheath diameter', 'optic nerve sheath thickness', 'ONSD', 'optic nerve sheath diameter (ONSD']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0175751', 'cui_str': 'Cervical collar'}]","[{'cui': 'C0228673', 'cui_str': 'Optic nerve sheath structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",60.0,0.277633,"The largest change at 5 minutes and 20 minutes was using Philly 4.73 (IQR: 4.49-4.895; P < .001) and 4.925 (IQR: 4.65-5.06; P < .001), respectively.","[{'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Ladny', 'Affiliation': 'Department of Trauma-Orthopedic Surgery, Solec Hospital, Warsaw, Poland.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Smereka', 'Affiliation': 'Department of Emergency Medical Service, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Sanchit', 'Initials': 'S', 'LastName': 'Ahuja', 'Affiliation': 'Department of Anesthesiology, Pain management and Perioperative Medicine, Henry Ford Health System, Detroit, MI.'}, {'ForeName': 'Lukasz', 'Initials': 'L', 'LastName': 'Szarpak', 'Affiliation': 'Medical Simulation Center, Lazarski University, Warsaw, Poland.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Ruetzler', 'Affiliation': 'Departments of Outcomes Research and General Anesthesiology, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Jerzy Robert', 'Initials': 'JR', 'LastName': 'Ladny', 'Affiliation': 'Clinic of Emergency Medicine, Medical University Bialystok, Bialystok, Poland.'}]",Medicine,['10.1097/MD.0000000000019740']
243,32311976,"A clinical study of traditional Chinese medicine prolonging the survival of advanced gastric cancer patients by regulating the immunosuppressive cell population: A study protocol for a multicenter, randomized controlled trail.","BACKGROUND


Gastric cancer (GC) is a common high-mortality disease, causing a serious social burden. Traditional Chinese medicine has been utilized to prevent and treat GC for many years but its effects remain unclear. The aim of our study is to elucidate the anti-tumor effects and the possible mechanism of Jianpi Yangzheng Xiaozheng decoction.
METHODS/DESIGN


This is a prospective, multicenter, randomized controlled trial continuing 1.5 years. Two hundred ten eligible patients will be randomly divided into 2 groups, the chemotherapy alone and the chemotherapy combined with JPYZXZ group at a ratio of 1:2. All patients will receive the treatment for 24 weeks and follow up for 1.5 years. The primary outcomes are one-year survival rate, progression-free survival, and overall survival (OS), while the secondary outcomes are immune related hematology test, objective response rate, tumor makers, traditional Chinese medicine syndrome points, fatigue scale, and quality of life scale. All of these outcomes will be analyzed at the end of the trail.
DISCUSSION


This study will provide the objective evidence for the efficacy and safety of Jianpi Yangzheng Xiaozheng decoction in advanced GC. Furthermore, it will be helpful to form a therapeutic regimen in advanced GC by the combination of traditional medicine and western medicine.Trail registration: ChiCTR1900028147.",2020,"The primary outcomes are one-year survival rate, progression-free survival, and overall survival (OS), while the secondary outcomes are immune related hematology test, objective response rate, tumor makers, traditional Chinese medicine syndrome points, fatigue scale, and quality of life scale.","['advanced GC', 'advanced gastric cancer patients by regulating the immunosuppressive cell population', 'Gastric cancer (GC', 'Two hundred ten eligible patients']","['Jianpi Yangzheng Xiaozheng decoction', 'traditional Chinese medicine', 'chemotherapy alone and the chemotherapy combined with JPYZXZ']","['one-year survival rate, progression-free survival, and overall survival (OS), while the secondary outcomes are immune related hematology test, objective response rate, tumor makers, traditional Chinese medicine syndrome points, fatigue scale, and quality of life scale']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0554244', 'cui_str': 'Maker'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}]",210.0,0.125357,"The primary outcomes are one-year survival rate, progression-free survival, and overall survival (OS), while the secondary outcomes are immune related hematology test, objective response rate, tumor makers, traditional Chinese medicine syndrome points, fatigue scale, and quality of life scale.","[{'ForeName': 'Xiaoting', 'Initials': 'X', 'LastName': 'Pan', 'Affiliation': 'The Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine.'}, {'ForeName': 'Heyun', 'Initials': 'H', 'LastName': 'Tao', 'Affiliation': 'The Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine.'}, {'ForeName': 'Mengjun', 'Initials': 'M', 'LastName': 'Nie', 'Affiliation': 'The Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine.'}, {'ForeName': 'Yuanjie', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'The Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine.'}, {'ForeName': 'Pan', 'Initials': 'P', 'LastName': 'Huang', 'Affiliation': 'Traditional Chinese Medicine Hospital of Zhangjiagang.'}, {'ForeName': 'Shenlin', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'The Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'The Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'The Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Ma', 'Affiliation': 'Changzhou TCM Hospital.'}, {'ForeName': 'Anwei', 'Initials': 'A', 'LastName': 'Dai', 'Affiliation': 'Traditional Chinese Medicine Hospital of Kunshan.'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Jiangsu Cancer Hospital.'}, {'ForeName': 'Baorui', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Nanjing Drum Tower Hospital, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zou', 'Affiliation': 'The Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine.'}, {'ForeName': 'Qingmin', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': 'The Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine.'}]",Medicine,['10.1097/MD.0000000000019757']
244,32311977,Clinical study on post evaluation after listing of Qizhi Weitong granules: Study protocol clinical trial (SPIRIT compliant).,"BACKGROUND


Functional dyspepsia (FD) is a highly prevalent functional gastrointestinal disorder which brings a significant impact on patients' quality of life. Although there are many available treatments to alleviate dyspepsia symptoms, most of them are far from satisfactory. Traditional Chinese medicine (TCM) has shown good potential in the treatment of FD, especially in terms of improving symptoms and adverse effects of Western medicine. Qizhi Weitong granule (QZWTG), a TCM preparation, has been utilized in treating FD for a long time and has achieved good clinical results. However, the existing evidence of its efficacy and mechanism of action is insufficient. Hence, the purpose of this study is to evaluate the efficacy and safety of QZWTG in the treatment of FD.
METHODS


This study is a multicenter, randomized, double-blinded, double-placebo, positive drug parallel controlled clinical study. The experiment will be carried out in 8 hospitals at the same time, and a total of 384 cases of participants will be randomly assigned to the experimental group and the control group (n = 192). The experimental group will be given QZWTG and Mosapride citrate tablet placebo, and the control group will be given QZWTG placebo and Mosapride citrate tablet. After 4 weeks of intervention and 2 weeks of follow-up, the efficacy and safety of QZWTG in patients with FD will be observed. The primary outcomes are the change in the main symptom score. The secondary outcomes include TCM syndrome evaluation, the change of the Hamilton anxiety scale and the Hamilton depression scale, and advanced events. This study will explore the biological mechanism of QZWTG in the treatment of FD through the results of blood and urine metabolomics.
DISCUSSION


This trial will provide first-hand evidence on whether QZWTG is noninferior to Mosapride citrate tablet. There will be a new option for the treatment of FD if noninferiority is set up. In addition, the efficacy and safety of QZWTG in the treatment of FD will be evaluated, and the mechanism of QZWTG in the treatment of FD will be explored through the metabolomics of blood and urine. On the other hand, as far as we know, this study may be the largest trial of efficacy and safety of QZWTG in the treatment of FD, which has important application value.",2020,"After 4 weeks of intervention and 2 weeks of follow-up, the efficacy and safety of QZWTG in patients with FD will be observed.","['patients with FD', '8 hospitals at the same time, and a total of 384 cases of participants']","['QZWTG and Mosapride citrate tablet placebo', 'placebo', 'QZWTG', 'Qizhi Weitong granule (QZWTG', 'Traditional Chinese medicine (TCM', 'QZWTG placebo and Mosapride citrate tablet']","['change in the main symptom score', 'efficacy and safety', 'TCM syndrome evaluation, the change of the Hamilton anxiety scale and the Hamilton depression scale, and advanced events', 'efficacy and safety of QZWTG']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0245956', 'cui_str': 'mosapride citrate'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}]",384.0,0.104168,"After 4 weeks of intervention and 2 weeks of follow-up, the efficacy and safety of QZWTG in patients with FD will be observed.","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'China Academy of Chinese Medical Sciences.'}, {'ForeName': 'Jiaqi', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology, Xiyuan Hospital of China Academy of Chinese Medical Sciences.'}, {'ForeName': 'Juanjuan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lv', 'Affiliation': 'Department of Gastroenterology, Xiyuan Hospital of China Academy of Chinese Medical Sciences.'}, {'ForeName': 'Zedan', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'China Academy of Chinese Medical Sciences.'}, {'ForeName': 'Fengyun', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Xiyuan Hospital of China Academy of Chinese Medical Sciences.'}, {'ForeName': 'Xudong', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'China Academy of Chinese Medical Sciences.'}]",Medicine,['10.1097/MD.0000000000019758']
245,32316911,Controlled trial of lovastatin combined with an open-label treatment of a parent-implemented language intervention in youth with fragile X syndrome.,"BACKGROUND


The purpose of this study was to conduct a 20-week controlled trial of lovastatin (10 to 40 mg/day) in youth with fragile X syndrome (FXS) ages 10 to 17 years, combined with an open-label treatment of a parent-implemented language intervention (PILI), delivered via distance video teleconferencing to both treatment groups, lovastatin and placebo.
METHOD


A randomized, double-blind trial was conducted at one site in the Sacramento, California, metropolitan area. Fourteen participants were assigned to the lovastatin group; two participants terminated early from the study. Sixteen participants were assigned to the placebo group. Lovastatin or placebo was administered orally in a capsule form, starting at 10 mg and increasing weekly or as tolerated by 10 mg increments, up to a maximum dose of 40 mg daily. A PILI was delivered to both groups for 12 weeks, with 4 activities per week, through video teleconferencing by an American Speech-Language Association-certified Speech-Language Pathologist, in collaboration with a Board-Certified Behavior Analyst. Parents were taught to use a set of language facilitation strategies while interacting with their children during a shared storytelling activity. The main outcome measures included absolute change from baseline to final visit in the means for youth total number of story-related utterances, youth number of different word roots, and parent total number of story-related utterances.
RESULTS


Significant increases in all primary outcome measures were observed in both treatment groups. Significant improvements were also observed in parent reports of the severity of spoken language and social impairments in both treatment groups. In all cases, the amount of change observed did not differ across the two treatment groups. Although gains in parental use of the PILI-targeted intervention strategies were observed in both treatment groups, parental use of the PILI strategies was correlated with youth gains in the placebo group and not in the lovastatin group.
CONCLUSION


Participants in both groups demonstrated significant changes in the primary outcome measures. The magnitude of change observed across the two groups was comparable, providing additional support for the efficacy of the use of PILI in youth with FXS.
TRIAL REGISTRATION


US National Institutes of Health (ClinicalTrials.gov), NCT02642653. Registered 12/30/2015.",2020,"Although gains in parental use of the PILI-targeted intervention strategies were observed in both treatment groups, parental use of the PILI strategies was correlated with youth gains in the placebo group and not in the lovastatin group.
","['Sixteen participants', 'youth with fragile X syndrome', 'one site in the Sacramento, California, metropolitan area', 'Fourteen participants', 'youth with fragile X syndrome (FXS) ages 10 to 17\u2009years']","['lovastatin combined with an open-label treatment of a parent-implemented language intervention', 'placebo', 'lovastatin', 'Lovastatin or placebo', 'combined with an open-label treatment of a parent-implemented language intervention (PILI), delivered via distance video teleconferencing to both treatment groups, lovastatin and placebo']","['absolute change from baseline to final visit in the means for youth total number of story-related utterances, youth number of different word roots, and parent total number of story-related utterances', 'severity of spoken language and social impairments']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0016667', 'cui_str': 'Fragile X syndrome'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0024027', 'cui_str': 'Lovastatin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0424919', 'cui_str': 'Language spoken'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",16.0,0.181326,"Although gains in parental use of the PILI-targeted intervention strategies were observed in both treatment groups, parental use of the PILI strategies was correlated with youth gains in the placebo group and not in the lovastatin group.
","[{'ForeName': 'Angela John', 'Initials': 'AJ', 'LastName': 'Thurman', 'Affiliation': 'MIND Institute, University of California Davis Health, 2825 50th Street, Room 2335, Sacramento, CA, 95817, USA. ajthurman@ucdavis.edu.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Potter', 'Affiliation': 'MIND Institute, University of California Davis Health, 2825 50th Street, Room 2335, Sacramento, CA, 95817, USA.'}, {'ForeName': 'Kyoungmi', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'MIND Institute, University of California Davis Health, 2825 50th Street, Room 2335, Sacramento, CA, 95817, USA.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Tassone', 'Affiliation': 'MIND Institute, University of California Davis Health, 2825 50th Street, Room 2335, Sacramento, CA, 95817, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Banasik', 'Affiliation': 'MIND Institute, University of California Davis Health, 2825 50th Street, Room 2335, Sacramento, CA, 95817, USA.'}, {'ForeName': 'Sarah Nelson', 'Initials': 'SN', 'LastName': 'Potter', 'Affiliation': 'MIND Institute, University of California Davis Health, 2825 50th Street, Room 2335, Sacramento, CA, 95817, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Bullard', 'Affiliation': 'MIND Institute, University of California Davis Health, 2825 50th Street, Room 2335, Sacramento, CA, 95817, USA.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Nguyen', 'Affiliation': 'MIND Institute, University of California Davis Health, 2825 50th Street, Room 2335, Sacramento, CA, 95817, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'McDuffie', 'Affiliation': 'MIND Institute, University of California Davis Health, 2825 50th Street, Room 2335, Sacramento, CA, 95817, USA.'}, {'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Hagerman', 'Affiliation': 'MIND Institute, University of California Davis Health, 2825 50th Street, Room 2335, Sacramento, CA, 95817, USA.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Abbeduto', 'Affiliation': 'MIND Institute, University of California Davis Health, 2825 50th Street, Room 2335, Sacramento, CA, 95817, USA.'}]",Journal of neurodevelopmental disorders,['10.1186/s11689-020-09315-4']
246,32330749,Human gut microbiome composition and tryptophan metabolites were changed differently by fast food and Mediterranean diet in 4 days: a pilot study.,"Diets rich in animal source foods vs plant-based diets have different macronutrient composition, and they have been shown to have differential effects on the gut microbiome. In this study, we hypothesized that diets with very different nutrient composition are able to change gut microbiome composition and metabolites in a very short period. We compared a fast food (FF) diet (ie, burgers and fries) with a Mediterranean (Med) diet, which is rich in vegetables, whole grains, olive oil, nuts, and fish. Ten healthy subjects participated in a controlled crossover study in which they consumed a Med diet and FF diet in randomized order for 4 days each, with a 4-day washout between treatments. Fecal DNA was extracted and the 16S V4 region amplified using polymerase chain reaction followed by sequencing on an Illumina MiSeq. Plasma metabolites and bile acids were analyzed using liquid chromatography-mass spectrometry. Certain bile-tolerant microbial genera and species including Collinsella, Parabacteroides, and Bilophila wadsworthia significantly increased after the FF diet. Some fiber-fermenting bacteria, including Lachnospiraceae and Butyricicoccus, increased significantly after the Med diet and decreased after the FF diet. Bacterially produced metabolites indole-3-lactic acid and indole-3-propionic acid, which have been shown to confer beneficial effects on neuronal cells, increased after the Med diet and decreased after the FF diet. Interindividual variability in response to the treatments may be related to differences in background diet, for example as shown by differences in Bilophila response in relationship to the saturated fat content of the baseline diet. In conclusion, an animal fat-rich, low-fiber FF diet v. a high-fiber Med diet altered human gut microbiome composition and its metabolites after just 4 days.",2020,"Some fiber-fermenting bacteria, including Lachnospiraceae and Butyricicoccus, increased significantly after the Med diet and decreased after the FF diet.",['Ten healthy subjects'],"['fast food (FF) diet (ie, burgers and fries) with a Mediterranean (Med) diet, which is rich in vegetables, whole grains, olive oil, nuts, and fish', 'Med diet and FF diet']","['Collinsella, Parabacteroides, and Bilophila wadsworthia', 'Plasma metabolites and bile acids']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0344355', 'cui_str': 'Convenience food'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0452929', 'cui_str': 'Burger'}, {'cui': 'C1510451', 'cui_str': 'French fries'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0028723', 'cui_str': 'Nut'}, {'cui': 'C0016163', 'cui_str': 'Fish'}]","[{'cui': 'C1047126', 'cui_str': 'Collinsella'}, {'cui': 'C1927848', 'cui_str': 'Parabacteroides'}, {'cui': 'C1005848', 'cui_str': 'Bilophila wadsworthia'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}]",10.0,0.0227447,"Some fiber-fermenting bacteria, including Lachnospiraceae and Butyricicoccus, increased significantly after the Med diet and decreased after the FF diet.","[{'ForeName': 'Chenghao', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: chhzhu@ucdavis.edu.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Sawrey-Kubicek', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: lsawreykubicek@ucdavis.edu.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Beals', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: egbeals@ucdavis.edu.'}, {'ForeName': 'Chris H', 'Initials': 'CH', 'LastName': 'Rhodes', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: chrhodes@ucdavis.edu.'}, {'ForeName': 'Hannah Eve', 'Initials': 'HE', 'LastName': 'Houts', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: hehouts@ucdavis.edu.'}, {'ForeName': 'Romina', 'Initials': 'R', 'LastName': 'Sacchi', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: rsacchi@ucdavis.edu.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Zivkovic', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: amzivkovic@ucdavis.edu.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.03.005']
247,31522843,"Antibiotic or silver versus standard ventriculoperitoneal shunts (BASICS): a multicentre, single-blinded, randomised trial and economic evaluation.","BACKGROUND


Insertion of a ventriculoperitoneal shunt for hydrocephalus is one of the commonest neurosurgical procedures worldwide. Infection of the implanted shunt affects up to 15% of these patients, resulting in prolonged hospital treatment, multiple surgeries, and reduced cognition and quality of life. Our aim was to determine the clinical and cost-effectiveness of antibiotic (rifampicin and clindamycin) or silver shunts compared with standard shunts at reducing infection.
METHODS


In this parallel, multicentre, single-blind, randomised controlled trial, we included patients with hydrocephalus of any aetiology undergoing insertion of their first ventriculoperitoneal shunt irrespective of age at 21 regional adult and paediatric neurosurgery centres in the UK and Ireland. Patients were randomly assigned (1:1:1 in random permuted blocks of three or six) to receive standard shunts (standard shunt group), antibiotic-impregnated (0·15% clindamycin and 0·054% rifampicin; antibiotic shunt group), or silver-impregnated shunts (silver shunt group) through a randomisation sequence generated by an independent statistician. All patients and investigators who recorded and analysed the data were masked for group assignment, which was only disclosed to the neurosurgical staff at the time of operation. Participants receiving a shunt without evidence of infection at the time of insertion were followed up for at least 6 months and a maximum of 2 years. The primary outcome was time to shunt failure due the infection and was analysed with Fine and Gray survival regression models for competing risk by intention to treat. This trial is registered with ISRCTN 49474281.
FINDINGS


Between June 26, 2013, and Oct 9, 2017, we assessed 3505 patients, of whom 1605 aged up to 91 years were randomly assigned to receive either a standard shunt (n=536), an antibiotic-impregnated shunt (n=538), or a silver shunt (n=531). 1594 had a shunt inserted without evidence of infection at the time of insertion (533 in the standard shunt group, 535 in the antibiotic shunt group, and 526 in the silver shunt group) and were followed up for a median of 22 months (IQR 10-24; 53 withdrew from follow-up). 32 (6%) of 533 evaluable patients in the standard shunt group had a shunt revision for infection, compared with 12 (2%) of 535 evaluable patients in the antibiotic shunt group (cause-specific hazard ratio [csHR] 0·38, 97·5% CI 0·18-0·80, p=0·0038) and 31 (6%) of 526 patients in the silver shunt group (0·99, 0·56-1·74, p=0·96). 135 (25%) patients in the standard shunt group, 127 (23%) in the antibiotic shunt group, and 134 (36%) in the silver shunt group had adverse events, which were not life-threatening and were mostly related to valve or catheter function.
INTERPRETATION


The BASICS trial provides evidence to support the adoption of antibiotic shunts in UK patients who are having their first ventriculoperitoneal shunt insertion. This practice will benefit patients of all ages by reducing the risk and harm of shunt infection.
FUNDING


UK National Institute for Health Research Health Technology Assessment programme.",2019,"1594 had a shunt inserted without evidence of infection at the time of insertion (533 in the standard shunt group, 535 in the antibiotic shunt group, and 526 in the silver shunt group) and were followed up for a median of 22 months (IQR 10-24; 53 withdrew from follow-up).","['UK patients who are having their first ventriculoperitoneal shunt insertion', 'Between June 26, 2013, and Oct 9, 2017', 'patients with hydrocephalus of any aetiology undergoing insertion of their first ventriculoperitoneal shunt irrespective of age at 21 regional adult and paediatric neurosurgery centres in the UK and Ireland', '3505 patients, of whom 1605 aged up to 91 years']","['antibiotic-impregnated shunt (n=538), or a silver shunt', 'Antibiotic or silver versus standard ventriculoperitoneal shunts (BASICS', 'antibiotic (rifampicin and clindamycin', 'standard shunt', 'standard shunts (standard shunt group), antibiotic-impregnated (0·15% clindamycin and 0·054% rifampicin; antibiotic shunt group), or silver-impregnated shunts (silver shunt group) through a randomisation sequence generated by an independent statistician', 'silver shunts', 'ventriculoperitoneal shunt']","['specific hazard ratio [csHR', 'shunt revision for infection', 'adverse events', 'time to shunt failure due the infection', 'cognition and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0175662', 'cui_str': 'Ventriculoperitoneal shunt device (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0020255', 'cui_str': 'Hydrocephaly'}, {'cui': 'C1314792', 'cui_str': 'Causality'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022067', 'cui_str': 'Ireland, Republic of'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1442858', 'cui_str': 'Surgical fistula'}, {'cui': 'C0037125', 'cui_str': 'Silver'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0175662', 'cui_str': 'Ventriculoperitoneal shunt device (physical object)'}, {'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C0008947', 'cui_str': 'Clindamycin'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0334957', 'cui_str': 'Statistician (occupation)'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1442858', 'cui_str': 'Surgical fistula'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0034380'}]",526.0,0.179442,"1594 had a shunt inserted without evidence of infection at the time of insertion (533 in the standard shunt group, 535 in the antibiotic shunt group, and 526 in the silver shunt group) and were followed up for a median of 22 months (IQR 10-24; 53 withdrew from follow-up).","[{'ForeName': 'Conor L', 'Initials': 'CL', 'LastName': 'Mallucci', 'Affiliation': ""Department of Paediatric Neurosurgery, Alder Hey Children's Hospital, Liverpool, UK. Electronic address: cmallucci@me.com.""}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Jenkinson', 'Affiliation': 'Department of Neurosurgery, Walton Centre National Health Service Foundation Trust, Liverpool, UK; Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Conroy', 'Affiliation': 'Clinical Trials Research Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Hartley', 'Affiliation': ""Department of Microbiology, Great Ormond Street Children's Hospital, London, UK.""}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': 'Clinical Trials Research Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Dalton', 'Affiliation': 'Clinical Trials Research Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Kearns', 'Affiliation': 'Clinical Trials Research Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Moitt', 'Affiliation': 'Clinical Trials Research Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Griffiths', 'Affiliation': ""Department of Paediatric Neurology, Alder Hey Children's Hospital, Liverpool, UK; Institute of Infection and Global Health, University of Liverpool, Liverpool, UK.""}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Culeddu', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Solomon', 'Affiliation': 'Department of Neurology, Walton Centre National Health Service Foundation Trust, Liverpool, UK; Institute of Infection and Global Health, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Dyfrig', 'Initials': 'D', 'LastName': 'Hughes', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK.'}, {'ForeName': 'Carrol', 'Initials': 'C', 'LastName': 'Gamble', 'Affiliation': 'Clinical Trials Research Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)31603-4']
248,31791665,"The renal hemodynamic effects of the SGLT2 inhibitor dapagliflozin are caused by post-glomerular vasodilatation rather than pre-glomerular vasoconstriction in metformin-treated patients with type 2 diabetes in the randomized, double-blind RED trial.","Sodium-glucose cotransporter 2 inhibitors (SGLT2i) improve hard renal outcomes in type 2 diabetes. This is possibly explained by the fact that SGLT2i normalize the measured glomerular filtration rate (mGFR) by increasing renal vascular resistance, as was shown in young people with type 1 diabetes and glomerular hyperfiltration. Therefore, we compared the renal hemodynamic effects of dapagliflozin with gliclazide in type 2 diabetes. The mGFR and effective renal plasma flow were assessed using inulin and para-aminohippurate clearances in the fasted state, during clamped euglycemia (5 mmol/L) and during clamped hyperglycemia (15 mmol/L). Filtration fraction and renal vascular resistance were calculated. Additionally, factors known to modulate renal hemodynamics were measured. In 44 people with type 2 diabetes on metformin monotherapy (Hemoglobin A1c 7.4%, mGFR 113 mL/min), dapagliflozin versus gliclazide reduced mGFR by 5, 10, and 12 mL/min in the consecutive phases while both agents similarly improved Hemoglobin A1c (-0.48% vs -0.65%). Dapagliflozin also reduced filtration fraction without increasing renal vascular resistance, and increased urinary adenosine and prostaglandin concentrations. Gliclazide did not consistently alter renal hemodynamic parameters. Thus, beyond glucose control, SGLT2i reduce mGFR and filtration fraction in type 2 diabetes. The fact that renal vascular resistance was not increased by dapagliflozin suggests that this is due to post-glomerular vasodilation rather than pre-glomerular vasoconstriction.",2020,"Dapagliflozin also reduced filtration fraction without increasing renal vascular resistance, and increased urinary adenosine and prostaglandin concentrations.","['44 people with type 2 diabetes on', 'type 2 diabetes', 'young people with type 1 diabetes and glomerular hyperfiltration', 'treated patients with type 2 diabetes']","['dapagliflozin versus gliclazide', 'SGLT2 inhibitor dapagliflozin', 'metformin', 'Gliclazide', 'Sodium-glucose cotransporter 2 inhibitors (SGLT2i', 'dapagliflozin', 'metformin monotherapy', 'dapagliflozin with gliclazide', 'Dapagliflozin']","['renal hemodynamic effects', 'urinary adenosine and prostaglandin concentrations', 'renal hemodynamic parameters', 'Hemoglobin A1c', 'renal hemodynamics', 'mGFR and effective renal plasma flow', 'renal vascular resistance', 'glomerular filtration rate (mGFR', 'Filtration fraction and renal vascular resistance']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0017631', 'cui_str': 'Gliclazide'}, {'cui': 'C3273807', 'cui_str': 'Gliflozins'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0001443', 'cui_str': 'Adenosine'}, {'cui': 'C0356622', 'cui_str': 'Prostaglandins, oxytocics'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0206088', 'cui_str': 'ERPF'}, {'cui': 'C0429119', 'cui_str': 'Vascular resistance (observable entity)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0016107', 'cui_str': 'Filtration - action'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}]",113.0,0.0276821,"Dapagliflozin also reduced filtration fraction without increasing renal vascular resistance, and increased urinary adenosine and prostaglandin concentrations.","[{'ForeName': 'Erik J M', 'Initials': 'EJM', 'LastName': 'van Bommel', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, location VUMC, Amsterdam, The Netherlands. Electronic address: e.vanbommel@amsterdamumc.nl.'}, {'ForeName': 'Marcel H A', 'Initials': 'MHA', 'LastName': 'Muskiet', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, location VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Michaël J B', 'Initials': 'MJB', 'LastName': 'van Baar', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, location VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Tonneijck', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, location VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Mark M', 'Initials': 'MM', 'LastName': 'Smits', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, location VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Emanuel', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, location VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bozovic', 'Affiliation': 'Department of Clinical Biochemistry, University Health Network, University of Toronto, Toronto, Ontario, Canada; Department of Laboratory Medicine and Pathobiology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'A H Jan', 'Initials': 'AHJ', 'LastName': 'Danser', 'Affiliation': 'Division of Pharmacology and Vascular Medicine, Department of Internal Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Geurts', 'Affiliation': 'Division of Nephrology and Transplantation, Department of Internal Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Ewout J', 'Initials': 'EJ', 'LastName': 'Hoorn', 'Affiliation': 'Division of Nephrology and Transplantation, Department of Internal Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Daan J', 'Initials': 'DJ', 'LastName': 'Touw', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Emil L', 'Initials': 'EL', 'LastName': 'Larsen', 'Affiliation': 'Department of Clinical Pharmacology, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Henrik E', 'Initials': 'HE', 'LastName': 'Poulsen', 'Affiliation': 'Department of Clinical Pharmacology, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mark H H', 'Initials': 'MHH', 'LastName': 'Kramer', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, location VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Nieuwdorp', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, location VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Jaap A', 'Initials': 'JA', 'LastName': 'Joles', 'Affiliation': 'Department of Nephrology and Hypertension, University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Daniël H', 'Initials': 'DH', 'LastName': 'van Raalte', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, location VUMC, Amsterdam, The Netherlands.'}]",Kidney international,['10.1016/j.kint.2019.09.013']
249,31178433,Effects of Treatment of Impaired Glucose Tolerance or Recently Diagnosed Type 2 Diabetes With Metformin Alone or in Combination With Insulin Glargine on β-Cell Function: Comparison of Responses In Youth And Adults.,"β-Cell dysfunction is central to the pathogenesis of impaired glucose tolerance (IGT) and type 2 diabetes. Compared with adults, youth have hyperresponsive β-cells and their decline in β-cell function appears to be more rapid. However, there are no direct comparisons of β-cell responses to pharmacological intervention between the two age-groups. The Restoring Insulin Secretion (RISE) Adult Medication Study and the RISE Pediatric Medication Study compared interventions to improve or preserve β-cell function. Obese youth ( n  = 91) and adults ( n  = 132) with IGT or recently diagnosed type 2 diabetes were randomized to 3 months of insulin glargine followed by 9 months of metformin, or 12 months of metformin. Hyperglycemic clamps conducted at baseline, after 12 months of medication, and 3 months after medication withdrawal assessed β-cell function as steady-state and maximal C-peptide responses adjusted for insulin sensitivity. Temporal changes in β-cell function were distinctly different. In youth, β-cell function deteriorated during treatment and after treatment withdrawal, with no differences between treatment groups. In adults, β-cell function improved during treatment, but this was not sustained after treatment withdrawal. The difference in β-cell function outcomes in response to medications in youth versus adults supports a more adverse trajectory of β-cell deterioration in youth.",2019,"In youth, β-cell function deteriorated during treatment and after treatment withdrawal, with no differences between treatment groups.","['Obese youth ( n  = 91) and adults ( n  = 132) with IGT or recently diagnosed type 2 diabetes', 'Youth And Adults']","['insulin glargine', 'metformin, or 12 months of metformin', 'Metformin Alone or in Combination With Insulin Glargine']","['β-cell function', 'Restoring Insulin Secretion (RISE', 'β-cell function as steady-state and maximal C-peptide responses adjusted for insulin sensitivity']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}]",132.0,0.028769,"In youth, β-cell function deteriorated during treatment and after treatment withdrawal, with no differences between treatment groups.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes,['10.2337/db19-0299']
250,30365024,Measurement of Electronic Cigarette Frequency of Use Among Smokers Participating in a Randomized Controlled Trial.,"BACKGROUND


The United States Food and Drug Administration has prioritized understanding the dependence potential of electronic cigarettes (e-cigs). Dependence is often estimated in part by examining frequency of use; however measures of e-cig use are not well developed because of varying product types. This study used an e-cig automatic puff counter to evaluate the value of self-reported e-cig use measures in predicting actual use (puffs).
METHODS


Data were collected from a two-site randomized placebo-controlled trial evaluating the effects of e-cigs on toxicant exposure in smokers attempting to reduce their cigarette consumption. Participants randomized to an e-cig condition self-reported their e-cig frequency of use (times per day-one ""time"" consists of around 15 puffs or lasts around 10 minutes) on the Penn State Electronic Cigarette Dependence Index (PSECDI) and kept daily diary records of the number of puffs per day from the e-cig automatic puff counter. A linear mixed-effects model was used to determine the predictive value of the times per day measure. Correlations were used to further investigate the relationship.
RESULTS


A total of 259 participants with 1165 observations of e-cig use were analyzed. Self-reported e-cig use in times per day was a significant predictor of e-cig puffs per day (p < .01). The Spearman correlation between measures was r equal to .58. Examination of individual participant responses revealed some potential difficulties reporting and interpreting times per day because of the difference in use patterns between cigarettes and e-cigs.
CONCLUSION


This study provides evidence that the self-reported PSECDI measure of times per day is a significant predictor of actual frequency of e-cig puffs taken.
IMPLICATIONS


Self-reported measures of e-cig frequency of use are predictive of actual use, but quantifying e-cig use in patterns similar to cigarettes is problematic.",2020,Self-reported e-cig use in times per day was a significant predictor of e-cig puffs per day (p<.01).,"['smokers attempting to reduce their cigarette consumption', '259 participants with 1165 observations of e-cig use were analyzed', 'smokers participating']","['e-cig condition self-reported their e-cig frequency of use (times per day - one ""time"" consists of around 15 puffs or lasts around 10 minutes) on the Penn State Electronic Cigarette Dependence Index (PSECDI', 'placebo']",[],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption (observable entity)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C4280017', 'cui_str': 'E-Cig Use'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C1533107', 'cui_str': 'Puffs'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],259.0,0.038409,Self-reported e-cig use in times per day was a significant predictor of e-cig puffs per day (p<.01).,"[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Yingst', 'Affiliation': 'Penn State Tobacco Center of Regulatory Science, Pennsylvania State University, Hershey, PA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Foulds', 'Affiliation': 'Penn State Tobacco Center of Regulatory Science, Pennsylvania State University, Hershey, PA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Veldheer', 'Affiliation': 'Penn State Tobacco Center of Regulatory Science, Pennsylvania State University, Hershey, PA.'}, {'ForeName': 'Caroline O', 'Initials': 'CO', 'LastName': 'Cobb', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Miao-Shan', 'Initials': 'MS', 'LastName': 'Yen', 'Affiliation': 'Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Shari', 'Initials': 'S', 'LastName': 'Hrabovsky', 'Affiliation': 'Penn State Tobacco Center of Regulatory Science, Pennsylvania State University, Hershey, PA.'}, {'ForeName': 'Sophia I', 'Initials': 'SI', 'LastName': 'Allen', 'Affiliation': 'Penn State Tobacco Center of Regulatory Science, Pennsylvania State University, Hershey, PA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bullen', 'Affiliation': 'University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Eissenberg', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond, VA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/nty233']
251,31217579,Management of primary pterygium with intra-lesional injection of 5 flurouracil and bevacizumab (Avastin).,"BACKGROUND


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


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


The injection of 5 fluorouracil and Avastin act synergistically to arrest progression and induce atrophy in primary pterygium. This is related to the effect of agents on fibroblasts, collagen, and vascular tissues. Such medical intervention is a safe and viable option in the management of primary pterygium though excision of residual tissue is still required in some cases. Longer follow up is needed to ascertain whether this will reduce the recurrence rate following excision.",2019,"VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I were all reduced in the injected samples.
","['primary pterygium', 'Fourteen eyes of 14 patients', 'primary pterygium with intra-lesional injection of 5', 'Sixteen eyes with primary pterygium']","['combined 5FU and Avastin injections', 'intralesional 5 fluorouracil and Avastin', 'primary pterygium who did not receive injections (control) and subjected to immunohistological examination for beta fibroblast growth factor (bFGF', 'fluorouracil and Avastin', 'flurouracil and bevacizumab (Avastin']","['Pterygium progression', 'vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), von-Willebrand factor (vWF), lymphatic vessel endothelial hyaluronan receptor (LYVE-1) and collagen-I', 'redness', 'VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I', 'recurrence rate']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C1135130', 'cui_str': 'Avastin'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0016026', 'cui_str': 'DNA Synthesis Factor'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0242275', 'cui_str': 'Epidermal Growth Factor'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0229889', 'cui_str': 'Structure of lymphatic vessel'}, {'cui': 'C0243982', 'cui_str': 'Hyaluronan Receptors'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",,0.0193891,"VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I were all reduced in the injected samples.
","[{'ForeName': 'Noha', 'Initials': 'N', 'LastName': 'Ghoz', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Britton', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Ross', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Mohammed', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Hogan', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Dalia G', 'Initials': 'DG', 'LastName': 'Said', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Harminder S', 'Initials': 'HS', 'LastName': 'Dua', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK. harminder.dua@nottingham.ac.uk.'}]","Eye (London, England)",['10.1038/s41433-019-0493-0']
252,31096264,Influence of Δ9-tetrahydrocannabinol on long-term neural correlates of threat extinction memory retention in humans.,"The neural mechanisms and durability of Δ9-tetrahydrocannabinol (THC) impact on threat processing in humans are not fully understood. Herein, we used functional MRI and psychophysiological tools to examine the influence of THC on the mechanisms of conditioned threat extinction learning, and the effects of THC on extinction memory retention when assessed 1 day and 1 week from learning. Healthy participants underwent threat conditioning on day 1. On day 2, participants were randomized to take one pill of THC or placebo (PBO) 2-h before threat extinction learning. Extinction memory retention was assessed 1 day and 1 week after extinction learning. We found that THC administration increased amygdala and ventromedial prefrontal cortex (vmPFC) activation during early extinction learning with no significant impact on skin conductance responses (SCR). When extinction memory retention was tested 24 h after learning, the THC group exhibited lower SCRs to the extinguished cue with no significant extinction-induced activations within the extinction network. When extinction memory retention was tested 1 week after learning, the THC group exhibited significantly decreased responses to the extinguished cues within the vmPFC and amygdala, but significantly increased functional coupling between the vmPFC, hippocampus, and dorsal anterior cingulate cortex during this extinction retention test. Our results are the first to report a long-term impact of one dose of THC on the functional activation of the threat extinction network and unveil a significant change in functional connectivity emerging after a week from engagement. We highlight the need for further investigating the long-term impact of THC on threat and anxiety circuitry.",2019,"When extinction memory retention was tested 24 h after learning, the THC group exhibited lower SCRs to the extinguished cue with no significant extinction-induced activations within the extinction network.","['humans', 'Healthy participants underwent threat conditioning on day 1']","['Δ9-tetrahydrocannabinol (THC', 'THC', 'Δ9-tetrahydrocannabinol', 'THC or placebo (PBO) 2-h before threat extinction learning']","['extinction memory retention', 'amygdala and ventromedial prefrontal cortex (vmPFC) activation', 'Extinction memory retention', 'functional coupling between the vmPFC, hippocampus, and dorsal anterior cingulate cortex', 'skin conductance responses (SCR']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}]","[{'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C3850122', 'cui_str': 'Ventral Medial Prefrontal Cortex'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0949582', 'cui_str': 'Seahorses'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C1123023', 'cui_str': 'Skin'}]",,0.0325937,"When extinction memory retention was tested 24 h after learning, the THC group exhibited lower SCRs to the extinguished cue with no significant extinction-induced activations within the extinction network.","[{'ForeName': 'Mira Z', 'Initials': 'MZ', 'LastName': 'Hammoud', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, USA. mhammoud@uic.edu.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Peters', 'Affiliation': 'Department of Pharmacy Practice and Department of Psychiatry & Behavioral Neuroscience, Wayne State University, Detroit, USA.'}, {'ForeName': 'Joshua R B', 'Initials': 'JRB', 'LastName': 'Hatfield', 'Affiliation': 'Department of Pharmacy Practice and Department of Psychiatry & Behavioral Neuroscience, Wayne State University, Detroit, USA.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Gorka', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, USA.'}, {'ForeName': 'K Luan', 'Initials': 'KL', 'LastName': 'Phan', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, USA.'}, {'ForeName': 'Mohammed R', 'Initials': 'MR', 'LastName': 'Milad', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, USA.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Rabinak', 'Affiliation': 'Department of Pharmacy Practice and Department of Psychiatry & Behavioral Neuroscience, Wayne State University, Detroit, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0416-6']
253,31021390,Single-Fraction Stereotactic vs Conventional Multifraction Radiotherapy for Pain Relief in Patients With Predominantly Nonspine Bone Metastases: A Randomized Phase 2 Trial.,"Importance


Consensus is lacking as to the optimal radiotherapy dose and fractionation schedule for treating bone metastases.
Objective


To assess the relative efficacy of high-dose, single-fraction stereotactic body radiotherapy (SBRT) vs standard multifraction radiotherapy (MFRT) for alleviation of pain in patients with mostly nonspine bone metastases.
Design, Setting, and Participants


This prospective, randomized, single-institution phase 2 noninferiority trial conducted at a tertiary cancer care center enrolled 160 patients with radiologically confirmed painful bone metastases from September 19, 2014, through June 19, 2018. Patients were randomly assigned in a 1:1 ratio to receive either single-fraction SBRT (12 Gy for ≥4-cm lesions or 16 Gy for <4-cm lesions) or MFRT to 30 Gy in 10 fractions.
Main Outcomes and Measures


The primary end point was pain response, defined by international consensus criteria as a combination of pain score and analgesic use (daily morphine-equivalent dose). Pain failure (ie, lack of response) was defined as worsening pain score (≥2 points on a 0-to-10 scale), an increase in morphine-equivalent opioid dose of 50% or more, reirradiation, or pathologic fracture. We hypothesized that SBRT was noninferior to MFRT.
Results


In this phase 2 noninferiority trial of 96 men and 64 women (mean [SD] age, 62.4 [10.4] years), 81 patients received SBRT and 79 received MFRT. Among evaluable patients who received treatment per protocol, the single-fraction group had more pain responders than the MFRT group (complete response + partial response) at 2 weeks (34 of 55 [62%] vs 19 of 52 [36%]) (P = .01), 3 months (31 of 43 [72%] vs 17 of 35 [49%]) (P = .03), and 9 months (17 of 22 [77%] vs 12 of 26 [46%]) (P = .03). No differences were found in treatment-related toxic effects or quality-of-life scores after SBRT vs MFRT; local control rates at 1 and 2 years were higher in patients receiving single-fraction SBRT.
Conclusions and Relevance


Delivering high-dose, single-fraction SBRT seems to be an effective treatment option for patients with painful bone metastases. Among evaluable patients, SBRT had higher rates of pain response (complete response + partial response) than did MFRT and thus should be considered for patients expected to have relatively long survival.
Trial Registration


ClinicalTrials.gov identifier: NCT02163226.",2019,"No differences were found in treatment-related toxic effects or quality-of-life scores after SBRT vs MFRT; local control rates at 1 and 2 years were higher in patients receiving single-fraction SBRT.
","['tertiary cancer care center enrolled 160 patients with radiologically confirmed painful bone metastases from September 19, 2014, through June 19, 2018', '96 men and 64 women (mean [SD] age, 62.4 [10.4] years), 81 patients received', 'Patients With Predominantly Nonspine Bone Metastases', 'patients with mostly nonspine bone metastases', 'patients with painful bone metastases']","['SBRT', 'Single-Fraction Stereotactic vs Conventional Multifraction Radiotherapy', 'single-fraction stereotactic body radiotherapy (SBRT) vs standard multifraction radiotherapy (MFRT', 'single-fraction SBRT', 'MFRT']","['Pain failure (ie, lack of response', 'worsening pain score', 'Pain Relief', 'pain responders', 'pain response', 'pain response, defined by international consensus criteria as a combination of pain score and analgesic use (daily morphine-equivalent dose', 'toxic effects or quality-of-life scores']","[{'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",96.0,0.198972,"No differences were found in treatment-related toxic effects or quality-of-life scores after SBRT vs MFRT; local control rates at 1 and 2 years were higher in patients receiving single-fraction SBRT.
","[{'ForeName': 'Quynh-Nhu', 'Initials': 'QN', 'LastName': 'Nguyen', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Chun', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Chow', 'Affiliation': 'Department of Radiation Oncology, Odette Cancer Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Ritsuko', 'Initials': 'R', 'LastName': 'Komaki', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Zhongxing', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Rensi', 'Initials': 'R', 'LastName': 'Zacharia', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Bill K', 'Initials': 'BK', 'LastName': 'Szeto', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Welsh', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Hahn', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Fuller', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Bryan S', 'Initials': 'BS', 'LastName': 'Moon', 'Affiliation': 'Department of Orthopedic Oncology, The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Justin E', 'Initials': 'JE', 'LastName': 'Bird', 'Affiliation': 'Department of Orthopedic Oncology, The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Satcher', 'Affiliation': 'Department of Orthopedic Oncology, The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Patrick P', 'Initials': 'PP', 'LastName': 'Lin', 'Affiliation': 'Department of Orthopedic Oncology, The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Melenda', 'Initials': 'M', 'LastName': 'Jeter', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': ""O'Reilly"", 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Valerae O', 'Initials': 'VO', 'LastName': 'Lewis', 'Affiliation': 'Department of Orthopedic Oncology, The University of Texas MD Anderson Cancer Center, Houston.'}]",JAMA oncology,['10.1001/jamaoncol.2019.0192']
254,31042696,Effects of MDMA on attention to positive social cues and pleasantness of affective touch.,"The psychostimulant drug ±3,4-methylenedioxymethamphetamine (MDMA) reportedly produces distinctive feelings of empathy and closeness with others. MDMA increases social behavior in animal models and has shown promise in psychiatric disorders, such as autism spectrum disorder (ASD) and post-traumatic stress disorder (PTSD). How it produces these prosocial effects is not known. This behavioral and psychophysiological study examined the effects of MDMA, compared with the prototypical stimulant methamphetamine (MA), on two measures of social behavior in healthy young adults: (i) responses to socially relevant, ""affective"" touch, and (ii) visual attention to emotional faces. Men and women (N = 36) attended four sessions in which they received MDMA (0.75 or 1.5 mg/kg), MA (20 mg), or a placebo in randomized order under double-blind conditions. Responses to experienced and observed affective touch (i.e., being touched or watching others being touched) were assessed using facial electromyography (EMG), a proxy of affective state. Responses to emotional faces were assessed using electrooculography (EOG) in a measure of attentional bias. Subjective ratings were also included. We hypothesized that MDMA, but not MA, would enhance the ratings of pleasantness and psychophysiological responses to affective touch and increase attentional bias toward positive facial expressions. Consistent with this, we found that MDMA, but not MA, selectively enhanced ratings of pleasantness of experienced affective touch. Neither drug altered the ratings of pleasantness of observed touch. On the EOG measure of attentional bias, MDMA, but not MA, increased attention toward happy faces. These results provide new evidence that MDMA can enhance the experience of positive social interactions; in this case, pleasantness of physical touch and attentional bias toward positive facial expressions. The findings are consistent with evidence that the prosocial effects are unique to MDMA relative to another stimulant. Understanding the behavioral and neurobiological processes underlying the distinctive social effects of MDMA is a key step to developing the drug for psychiatric disorders.",2019,"On the EOG measure of attentional bias, MDMA, but not MA, increased attention toward happy faces.","['Men and women (N\u2009=\u200936) attended four sessions in which they received', 'healthy young adults']","['placebo', 'psychostimulant drug ±3,4-methylenedioxymethamphetamine (MDMA', 'MDMA', 'electrooculography (EOG', 'MA', 'prototypical stimulant methamphetamine (MA']","['ratings of pleasantness and psychophysiological responses to affective touch and increase attentional bias toward positive facial expressions', 'positive social cues and pleasantness of affective touch', 'Subjective ratings', 'ratings of pleasantness of observed touch', 'attention toward happy faces']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0304403', 'cui_str': 'Psychostimulant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C0013854', 'cui_str': 'EOG'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}]","[{'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C4277667', 'cui_str': 'Attentional Bias'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0015457', 'cui_str': 'Facial Expression'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}]",,0.0389876,"On the EOG measure of attentional bias, MDMA, but not MA, increased attention toward happy faces.","[{'ForeName': 'Anya K', 'Initials': 'AK', 'LastName': 'Bershad', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Leah M', 'Initials': 'LM', 'LastName': 'Mayo', 'Affiliation': 'Center for Social and Affective Neuroscience, Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Kathryne', 'Initials': 'K', 'LastName': 'Van Hedger', 'Affiliation': 'Department of Clinical Neurological Sciences, University of Western Ontario, London, ON, UK.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'McGlone', 'Affiliation': 'School of Natural Sciences and Psychology, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Susannah C', 'Initials': 'SC', 'LastName': 'Walker', 'Affiliation': 'School of Natural Sciences and Psychology, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA. hdew@uchicago.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0402-z']
255,31104833,"Burosumab versus conventional therapy in children with X-linked hypophosphataemia: a randomised, active-controlled, open-label, phase 3 trial.","BACKGROUND


X-linked hypophosphataemia in children is characterised by elevated serum concentrations of fibroblast growth factor 23 (FGF23), hypophosphataemia, rickets, lower extremity bowing, and growth impairment. We compared the efficacy and safety of continuing conventional therapy, consisting of oral phosphate and active vitamin D, versus switching to burosumab, a fully human monoclonal antibody against FGF23, in paediatric X-linked hypophosphataemia.
METHODS


In this randomised, active-controlled, open-label, phase 3 trial at 16 clinical sites, we enrolled children with X-linked hypophosphataemia aged 1-12 years. Key eligibility criteria were a total Thacher rickets severity score of at least 2·0, fasting serum phosphorus lower than 0·97 mmol/L (3·0 mg/dL), confirmed PHEX (phosphate-regulating endopeptidase homolog, X-linked) mutation or variant of unknown significance in the patient or a family member with appropriate X-linked dominant inheritance, and receipt of conventional therapy for at least 6 consecutive months for children younger than 3 years or at least 12 consecutive months for children older than 3 years. Eligible patients were randomly assigned (1:1) to receive either subcutaneous burosumab starting at 0·8 mg/kg every 2 weeks (burosumab group) or conventional therapy prescribed by investigators (conventional therapy group). Both interventions lasted 64 weeks. The primary endpoint was change in rickets severity at week 40, assessed by the Radiographic Global Impression of Change global score. All patients who received at least one dose of treatment were included in the primary and safety analyses. The trial is registered with ClinicalTrials.gov, number NCT02915705.
FINDINGS


Recruitment took place between Aug 3, 2016, and May 8, 2017. Of 122 patients assessed, 61 were enrolled. Of these, 32 (18 girls, 14 boys) were randomly assigned to continue receiving conventional therapy and 29 (16 girls, 13 boys) to receive burosumab. For the primary endpoint at week 40, patients in the burosumab group had significantly greater improvement in Radiographic Global Impression of Change global score than did patients in the conventional therapy group (least squares mean +1·9 [SE 0·1] with burosumab vs +0·8 [0·1] with conventional therapy; difference 1·1, 95% CI 0·8-1·5; p<0·0001). Treatment-emergent adverse events considered possibly, probably, or definitely related to treatment by the investigator occurred more frequently with burosumab (17 [59%] of 29 patients in the burosumab group vs seven [22%] of 32 patients in the conventional therapy group). Three serious adverse events occurred in each group, all considered unrelated to treatment and resolved.
INTERPRETATION


Significantly greater clinical improvements were shown in rickets severity, growth, and biochemistries among children with X-linked hypophosphataemia treated with burosumab compared with those continuing conventional therapy.
FUNDING


Ultragenyx Pharmaceutical and Kyowa Kirin International.",2019,"For the primary endpoint at week 40, patients in the burosumab group had significantly greater improvement in Radiographic Global Impression of Change global score than did patients in the conventional therapy group (least squares mean +1·9 [SE 0·1] with burosumab vs +0·8","['enrolled children with X-linked hypophosphataemia aged 1-12 years', '32 (18 girls, 14 boys', 'children with X-linked hypophosphataemia', '122 patients assessed, 61 were enrolled', 'Key eligibility criteria were a total Thacher rickets severity score of at least 2·0, fasting serum phosphorus lower than 0·97 mmol/L (3·0 mg/dL), confirmed PHEX (phosphate-regulating endopeptidase homolog, X-linked) mutation or variant of unknown significance in the patient or a family member with appropriate X-linked dominant inheritance, and receipt of conventional therapy for at least 6 consecutive months for children younger than 3 years or at least 12 consecutive months for children older than 3 years', 'Eligible patients']","['conventional therapy', 'subcutaneous burosumab starting at 0·8 mg/kg every 2 weeks (burosumab group) or conventional therapy prescribed by investigators (conventional therapy group', 'Burosumab versus conventional therapy', 'oral phosphate and active vitamin D']","['Radiographic Global Impression of Change global score', 'rickets severity, growth, and biochemistries', 'change in rickets severity', 'serious adverse events', 'efficacy and safety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3540852', 'cui_str': 'Hypophosphatemia, X-Linked'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0035579', 'cui_str': 'Rachitis'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0920102', 'cui_str': 'Phosphorus low'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0030946', 'cui_str': 'Endopeptidases'}, {'cui': 'C0241764', 'cui_str': 'X-linked inheritance (qualifier value)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0728826', 'cui_str': 'Inheritance (attribute)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C4301607', 'cui_str': 'burosumab'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035579', 'cui_str': 'Rachitis'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",61.0,0.0972279,"For the primary endpoint at week 40, patients in the burosumab group had significantly greater improvement in Radiographic Global Impression of Change global score than did patients in the conventional therapy group (least squares mean +1·9 [SE 0·1] with burosumab vs +0·8","[{'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Imel', 'Affiliation': 'Department of Medicine and Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, USA. Electronic address: eimel@iu.edu.'}, {'ForeName': 'Francis H', 'Initials': 'FH', 'LastName': 'Glorieux', 'Affiliation': 'Shriners Hospital for Children - Canada, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Whyte', 'Affiliation': 'Shriners Hospitals for Children - St Louis, St Louis, MO, USA.'}, {'ForeName': 'Craig F', 'Initials': 'CF', 'LastName': 'Munns', 'Affiliation': ""The University of Sydney Children's Hospital Westmead Clinical School, The Children's Hospital at Westmead, Westmead, NSW, Australia; Department of Endocrinology, The Children's Hospital at Westmead, Westmead, NSW, Australia.""}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Ward', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Nilsson', 'Affiliation': 'Center for Molecular Medicine, Karolinska Institutet, Stockholm, Sweden; School of Medical Sciences, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Jill H', 'Initials': 'JH', 'LastName': 'Simmons', 'Affiliation': 'Department of Pediatrics, Division of Endocrinology and Diabetes, Vanderbilt University School of Medicine, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Raja', 'Initials': 'R', 'LastName': 'Padidela', 'Affiliation': ""Department of Paediatric Endocrinology, Royal Manchester Children's Hospital, Manchester, UK.""}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Namba', 'Affiliation': 'Department of Pediatrics, Osaka Hospital, Japan Community Healthcare Organization, Osaka, Japan; Department of Pediatrics, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Hae Il', 'Initials': 'HI', 'LastName': 'Cheong', 'Affiliation': ""Seoul National University Children's Hospital, Seoul, Korea.""}, {'ForeName': 'Pisit', 'Initials': 'P', 'LastName': 'Pitukcheewanont', 'Affiliation': ""Center of Endocrinology, Diabetes and Metabolism, Children's Hospital of Los Angeles, Los Angeles, CA, USA.""}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Sochett', 'Affiliation': 'Department of Pediatrics, Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Högler', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Johannes Kepler University Linz, Linz, Austria; Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Muroya', 'Affiliation': ""Kanagawa Children's Medical Center, Yokohama, Japan.""}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Okayama Saiseikai General Hospital Outpatient Center, Okayama, Japan.'}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Gottesman', 'Affiliation': 'Shriners Hospitals for Children - St Louis, St Louis, MO, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Biggin', 'Affiliation': ""The University of Sydney Children's Hospital Westmead Clinical School, The Children's Hospital at Westmead, Westmead, NSW, Australia.""}, {'ForeName': 'Farzana', 'Initials': 'F', 'LastName': 'Perwad', 'Affiliation': 'Department of Pediatrics, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Mao', 'Affiliation': 'Ultragenyx Pharmaceutical, Novato, CA, USA.'}, {'ForeName': 'Chao-Yin', 'Initials': 'CY', 'LastName': 'Chen', 'Affiliation': 'Ultragenyx Pharmaceutical, Novato, CA, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Skrinar', 'Affiliation': 'Ultragenyx Pharmaceutical, Novato, CA, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'San Martin', 'Affiliation': 'Ultragenyx Pharmaceutical, Novato, CA, USA.'}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Portale', 'Affiliation': 'Department of Pediatrics, University of California, San Francisco, San Francisco, CA, USA.'}]","Lancet (London, England)",['10.1016/S0140-6736(19)30654-3']
256,32329438,Enhancing Patient Activation and Self-Management Activities in Patients With Type 2 Diabetes Using the US Department of Defense Mobile Health Care Environment: Feasibility Study.,"BACKGROUND


Past mobile health (mHealth) efforts to empower type 2 diabetes (T2D) self-management include portals, text messaging, collection of biometric data, electronic coaching, email, and collection of lifestyle information.
OBJECTIVE


The primary objective was to enhance patient activation and self-management of T2D using the US Department of Defense's Mobile Health Care Environment (MHCE) in a patient-centered medical home setting.
METHODS


A multisite study, including a user-centered design and a controlled trial, was conducted within the US Military Health System. Phase I assessed preferences regarding the enhancement of the enabling technology. Phase II was a single-blinded 12-month feasibility study that randomly assigned 240 patients to either the intervention (n=123, received mHealth technology and behavioral messages tailored to Patient Activation Measure [PAM] level at baseline) or the control group (n=117, received equipment but not messaging. The primary outcome measure was PAM scores. Secondary outcome measures included Summary of Diabetes Self-Care Activities (SDSCA) scores and cardiometabolic outcomes. We used generalized estimating equations to estimate changes in outcomes.
RESULTS


The final sample consisted of 229 patients. Participants were 61.6% (141/229) male, had a mean age of 62.9 years, mean glycated hemoglobin (HbA 1c ) of 7.5%, mean BMI of 32.7, and a mean duration of T2D diagnosis of 9.8 years. At month 12, the control group showed significantly greater improvements compared with the intervention group in PAM scores (control mean 7.49, intervention mean 1.77; P=.007), HbA 1c  (control mean -0.53, intervention mean -0.11; P=.006), and low-density lipoprotein cholesterol (control mean -7.14, intervention mean 4.38; P=.01). Both groups showed significant improvement in SDSCA, BMI, waist size, and diastolic blood pressure; between-group differences were not statistically significant. Except for patients with the highest level of activation (PAM level 4), intervention group patients exhibited significant improvements in PAM scores. For patients with the lowest level of activation (PAM level 1), the intervention group showed significantly greater improvement compared with the control group in HbA 1c  (control mean -0.09, intervention mean -0.52; P=.04), BMI (control mean 0.58, intervention mean -1.22; P=.01), and high-density lipoprotein cholesterol levels (control mean -4.86, intervention mean 3.56; P<.001). Significant improvements were seen in AM scores, SDSCA, and waist size for both groups and in diastolic and systolic blood pressure for the control group; the between-group differences were not statistically significant. The percentage of participants who were engaged with MHCE for ≥50% of days period was 60.7% (68/112; months 0-3), 57.4% (62/108; months 3-6), 49.5% (51/103; months 6-9), and 43% (42/98; months 9-12).
CONCLUSIONS


Our study produced mixed results with improvement in PAM scores and outcomes in both the intervention and control groups. Structural design issues may have hampered the influence of tailored behavioral messaging within the intervention group.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02949037; https://clinicaltrials.gov/ct2/show/NCT02949037.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.2196/resprot.6993.",2020,"At month 12, the control group saw significantly greater improvements compared to the intervention group in PAM® score (control mean: 7.49, intervention mean: 1.77; P=.007), HbA1c (control mean:","['participants had mean age of 62.8 years, mean HbA1c of 7.5', 'Patients with Type 2 Diabetes using the U.S. Department of Defense Mobile Health Care Environment', '240 patients to either the']","['MHCE intervention (n=123, received enabling mHealth technology and behavioral messages tailored to Patient Activation Measure® (PAM®) level at baseline or the control group (n=117, received equipment but not behavioral messaging, ""intervention-lite']","['PAM® scores', 'PAM® score', 'BMI', 'Summary of Diabetes Self-care Activities (SDSCA) scores and cardiometabolic outcomes', 'HDL cholesterol levels', 'LDL cholesterol (control mean', 'PAM® score, SDSCA, and waist size for both groups, and diastolic and systolic blood pressure', 'SDSCA, BMI, waist size, and diastolic blood pressure']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0557735', 'cui_str': 'Caring environment'}, {'cui': 'C4319600', 'cui_str': '240'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0557735', 'cui_str': 'Caring environment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4075707', 'cui_str': 'Patient Activation Measure'}, {'cui': 'C2931826', 'cui_str': 'Potassium aggravated myotonia'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}]","[{'cui': 'C2931826', 'cui_str': 'Potassium aggravated myotonia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",240.0,0.02861,"At month 12, the control group saw significantly greater improvements compared to the intervention group in PAM® score (control mean: 7.49, intervention mean: 1.77; P=.007), HbA1c (control mean:","[{'ForeName': 'Ronald W', 'Initials': 'RW', 'LastName': 'Gimbel', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC, United States.'}, {'ForeName': 'Lior M', 'Initials': 'LM', 'LastName': 'Rennert', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC, United States.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Crawford', 'Affiliation': ""Nellis Family Medicine Residency Program, Mike O'Callaghan Federal Hospital, Las Vegas, NV, United States.""}, {'ForeName': 'Jeanette R', 'Initials': 'JR', 'LastName': 'Little', 'Affiliation': 'Mobile Health Innovation Center, Telemedicine & Advanced Technologies Research Center, U.S. Army Medical Research & Materials Command, Fort Gordon, GA, United States.'}, {'ForeName': 'Khoa', 'Initials': 'K', 'LastName': 'Truong', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC, United States.'}, {'ForeName': 'Joel E', 'Initials': 'JE', 'LastName': 'Williams', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC, United States.'}, {'ForeName': 'Sarah F', 'Initials': 'SF', 'LastName': 'Griffin', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC, United States.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC, United States.'}, {'ForeName': 'Liwei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Fielding School of Public Health, University of California Los Angeles, Los Angeles, CA, United States.'}, {'ForeName': 'LingLing', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA, United States.'}, {'ForeName': 'Jennie B', 'Initials': 'JB', 'LastName': 'Moss', 'Affiliation': ""Nellis Family Medicine Residency Program, Mike O'Callaghan Federal Hospital, Las Vegas, NV, United States.""}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Marshall', 'Affiliation': 'Clinical Informatics Fellowship Program, Madigan Army Medical Center, Tacoma, WA, United States.'}, {'ForeName': 'Karen W', 'Initials': 'KW', 'LastName': 'Edwards', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC, United States.'}, {'ForeName': 'Kristy J', 'Initials': 'KJ', 'LastName': 'Crawford', 'Affiliation': ""Nellis Family Medicine Residency Program, Mike O'Callaghan Federal Hospital, Las Vegas, NV, United States.""}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hing', 'Affiliation': 'Department of Internal Medicine, Madigan Army Medical Center, Tacoma, WA, United States.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Schmeltz', 'Affiliation': 'Mobile Health Innovation Center, Telemedicine & Advanced Technologies Research Center, U.S. Army Medical Research & Materials Command, Fort Gordon, GA, United States.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Lumsden', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC, United States.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Ashby', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC, United States.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Haas', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC, United States.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Palazzo', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC, United States.'}]",Journal of medical Internet research,['10.2196/17968']
257,31699604,Family-Based Mental Health Promotion for Somali Bantu and Bhutanese Refugees: Feasibility and Acceptability Trial.,"PURPOSE


There are disparities in mental health of refugee youth compared with the general U.S.
POPULATION


We conducted a pilot feasibility and acceptability trial of the home-visiting Family Strengthening Intervention for refugees (FSI-R) using a community-based participatory research approach. The FSI-R aims to promote youth mental health and family relationships. We hypothesized that FSI-R families would have better psychosocial outcomes and family functioning postintervention compared with care-as-usual (CAU) families. We hypothesized that FSI-R would be feasible to implement and accepted by communities.
METHODS


A total of 40 Somali Bantu (n = 103 children, 58.40% female; n = 43 caregivers, 79.00% female) and 40 Bhutanese (n = 49 children, 55.30% female; n = 62 caregivers, 54.00% female) families were randomized to receive FSI-R or CAU. Refugee research assistants conducted psychosocial assessments pre- and post-intervention, and home visitors delivered the preventive intervention. Multilevel modeling assessed the effects of FSI-R. Feasibility was measured from retention, and acceptability was measured from satisfaction surveys.
RESULTS


The retention rate of 82.50% indicates high feasibility, and high reports of satisfaction (81.50%) indicate community acceptance. Across communities, FSI-R children reported reduced traumatic stress reactions, and caregivers reported fewer child depression symptoms compared with CAU families (β = -.42; p = .03; β = -.34; p = .001). Bhutanese FSI-R children reported reduced family arguing (β = -1.32; p = .04) and showed fewer depression symptoms and conduct problems by parent report (β = -9.20; p = .04; β = -.92; p = .01) compared with CAU. There were no significant differences by group on other measures.
CONCLUSIONS


A family-based home-visiting preventive intervention can be feasible and acceptable and has promise for promoting mental health and family functioning among refugees.",2020,We hypothesized that FSI-R families would have better psychosocial outcomes and family functioning postintervention compared with care-as-usual (CAU) families.,"['A total of 40 Somali Bantu (n\xa0= 103 children, 58.40% female; n\xa0= 43 caregivers, 79.00% female) and 40 Bhutanese (n\xa0= 49 children, 55.30% female; n\xa0= 62 caregivers, 54.00% female) families', 'Family-Based Mental Health Promotion for Somali Bantu and Bhutanese Refugees']","['FSI-R or CAU', 'home-visiting Family Strengthening Intervention']","['FSI-R. Feasibility', 'child depression symptoms', 'retention rate', 'depression symptoms and conduct problems', 'traumatic stress reactions']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0337847', 'cui_str': 'Somalis (ethnic group)'}, {'cui': 'C0337826', 'cui_str': 'Bantu (ethnic group)'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0337894', 'cui_str': 'Bhutanese (ethnic group)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0184645', 'cui_str': 'Mental health promotion'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}]","[{'cui': 'C0444892', 'cui_str': 'CAU'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}]",103.0,0.150707,We hypothesized that FSI-R families would have better psychosocial outcomes and family functioning postintervention compared with care-as-usual (CAU) families.,"[{'ForeName': 'Theresa S', 'Initials': 'TS', 'LastName': 'Betancourt', 'Affiliation': 'Research Program on Children and Adversity, Boston College School of Social Work, Chestnut Hill, Massachusetts. Electronic address: theresa.betancourt@bc.edu.'}, {'ForeName': 'Jenna M', 'Initials': 'JM', 'LastName': 'Berent', 'Affiliation': 'Research Program on Children and Adversity, Boston College School of Social Work, Chestnut Hill, Massachusetts.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Freeman', 'Affiliation': 'Research Program on Children and Adversity, Boston College School of Social Work, Chestnut Hill, Massachusetts.'}, {'ForeName': 'Rochelle L', 'Initials': 'RL', 'LastName': 'Frounfelker', 'Affiliation': 'Division of Social and Transcultural Psychiatry, Department of Psychiatry, McGill University, Montreal, Canada.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Brennan', 'Affiliation': ""Research Program on Children and Adversity, Boston College School of Social Work, Chestnut Hill, Massachusetts; Women's Studies Research Center, Brandeis University, Waltham, Massachusetts.""}, {'ForeName': 'Saida', 'Initials': 'S', 'LastName': 'Abdi', 'Affiliation': ""Refugee Trauma and Resilience Center, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Maalim', 'Affiliation': 'Research Program on Children and Adversity, Boston College School of Social Work, Chestnut Hill, Massachusetts.'}, {'ForeName': 'Abdirahman', 'Initials': 'A', 'LastName': 'Abdi', 'Affiliation': 'Research Program on Children and Adversity, Boston College School of Social Work, Chestnut Hill, Massachusetts.'}, {'ForeName': 'Tej', 'Initials': 'T', 'LastName': 'Mishra', 'Affiliation': 'Research Program on Children and Adversity, Boston College School of Social Work, Chestnut Hill, Massachusetts.'}, {'ForeName': 'Bhuwan', 'Initials': 'B', 'LastName': 'Gautam', 'Affiliation': 'Research Program on Children and Adversity, Boston College School of Social Work, Chestnut Hill, Massachusetts.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Creswell', 'Affiliation': 'Department of Family Medicine, University of Michigan Medical School, St. Ann Arbor, Michigan; College of Education and Human Services, University of Nebraska-Lincoln, Lincoln, Nebraska.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Beardslee', 'Affiliation': ""College of Education and Human Services, University of Nebraska-Lincoln, Lincoln, Nebraska; Judge Baker Children's Center, Harvard University, Boston, Massachusetts.""}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2019.08.023']
258,32325257,"A multicentre, randomised trial comparing schedules of G-CSF (filgrastim) administration for primary prophylaxis of chemotherapy-induced febrile neutropenia in early stage breast cancer.","BACKGROUND


The optimal duration of filgrastim as primary febrile neutropenia (FN) prophylaxis in early breast cancer patients is unknown, with 5, 7 or 10 days being commonly prescribed. This trial evaluates whether 5 days of filgrastim was non-inferior to 7/10 days.
PATIENTS AND METHODS


In this randomised, open-label trial, early breast cancer patients who were to receive filgrastim as primary FN prophylaxis were randomly allocated to 5 versus 7 versus 10 days of filgrastim for all chemotherapy cycles. A protocol amendment in November 2017 allowed subsequent patients (N = 324) to be randomised to either 5 or 7/10 days. The primary outcome was a composite of either FN or treatment-related hospitalisations. Secondary outcomes included chemotherapy dose reductions, delays and discontinuations. Analyses were carried out by per protocol (primary) and intention-to-treat, and the non-inferiority margin was set at 3% for the risk of having FN and/or hospitalisation per cycle of chemotherapy.
RESULTS


Patients (N = 466) were randomised to receive 5 (184, 39.5%), or 7/10 (282, 60.5%) days of filgrastim. In our primary analysis, the difference in risk of either FN or treatment-related hospitalisation per cycle was -1.52% [95% confidence interval (CI): -3.22% to 0.19%] suggesting non-inferiority of a 5-day filgrastim schedule compared with 7/10-days. The difference in events per cycle for FN was 0.11% (95% CI: -1.05 to 1.27) while for treatment-related hospitalisations it was -1.68% (95% CI: -2.73% to -0.63%). The overall proportions of patients having at least one occurrence of either FN or treatment-related hospitalisation were 11.8% and 14.96% for the 5- and 7/10-day groups, respectively (risk difference: -3.17%, 95% CI: -9.51% to 3.18%).
CONCLUSION


Five days of filgrastim was non-inferior to 7/10 days. Given the cost and toxicity of this agent, 5 days should be considered standard of care. CLINICALTRIALS.
GOV REGISTRATION


NCT02428114 and NCT02816164.",2020,The difference in events per cycle for FN was 0.11% (95%CI: -1.05 to 1.27) while for treatment-related hospitalisations it was -1.68% (95%CI: -2.73% to -0.63%).,"['early breast cancer (EBC) patients', 'Patient (N=466', 'November 2017 allowed subsequent patients (N=324', 'early stage breast cancer', 'EBC patients who were to receive filgrastim as primary FN prophylaxis']","['filgrastim', 'G-CSF (filgrastim']","['overall proportions of patients having at least one occurrence of either FN or treatment-related hospitalization', 'risk of either FN or treatment-related hospitalisation per cycle', 'events per cycle for FN', 'composite of either FN or treatment-related hospitalisations', 'chemotherapy dose reductions, delays, and discontinuations', 'febrile neutropenia']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",,0.248534,The difference in events per cycle for FN was 0.11% (95%CI: -1.05 to 1.27) while for treatment-related hospitalisations it was -1.68% (95%CI: -2.73% to -0.63%).,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Clemons', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, The Ottawa Hospital and University of Ottawa, Ottawa, Canada; Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada; Clinical Epidemiology Program, The Ottawa Hospital Research Institute, Ottawa, Canada. Electronic address: mclemons@toh.ca.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Fergusson', 'Affiliation': 'Division of Clinical Epidemiology, Department of Medicine, The Ottawa Hospital and University of Ottawa, Ottawa, Canada; Clinical Epidemiology Program, The Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Simos', 'Affiliation': 'The Stronach Regional Cancer Center, Newmarket, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mates', 'Affiliation': 'Cancer Centre of Southeastern Ontario, Kingston, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Robinson', 'Affiliation': 'Cancer Centre of Southeastern Ontario, Kingston, Canada.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Califaretti', 'Affiliation': 'Grand River Regional Cancer Centre, Kitchener, Canada.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zibdawi', 'Affiliation': 'The Stronach Regional Cancer Center, Newmarket, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bahl', 'Affiliation': 'Grand River Regional Cancer Centre, Kitchener, Canada.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Raphael', 'Affiliation': 'Department of Medical Oncology, Schulich School of Medicine & Dentistry, Western University and London Health Sciences Centre, London, Canada; Division of Medical Oncology, London Regional Cancer Program, Western University, London, Canada.'}, {'ForeName': 'M F K', 'Initials': 'MFK', 'LastName': 'Ibrahim', 'Affiliation': 'Thunder Bay Regional Health Research Institute, Thunder Bay, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Fernandes', 'Affiliation': 'Department of Medical Oncology, Schulich School of Medicine & Dentistry, Western University and London Health Sciences Centre, London, Canada.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Pitre', 'Affiliation': 'The Northeast Cancer Centre, Sudbury, Canada.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Aseyev', 'Affiliation': 'Thunder Bay Regional Health Research Institute, Thunder Bay, Canada.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Stober', 'Affiliation': 'Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Vandermeer', 'Affiliation': 'Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Saunders', 'Affiliation': 'Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hutton', 'Affiliation': 'Clinical Epidemiology Program, The Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mallick', 'Affiliation': 'Clinical Epidemiology Program, The Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'G R', 'Initials': 'GR', 'LastName': 'Pond', 'Affiliation': 'McMaster University, Hamilton, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Awan', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, The Ottawa Hospital and University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hilton', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, The Ottawa Hospital and University of Ottawa, Ottawa, Canada; Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.04.005']
259,31548349,Plasma 25-Hydroxyvitamin D Levels and Survival in Patients with Advanced or Metastatic Colorectal Cancer: Findings from CALGB/SWOG 80405 (Alliance).,"PURPOSE


Previous studies have suggested that higher circulating 25-hydroxyvitamin D [25(OH)D] levels are associated with decreased colorectal cancer risk and improved survival. However, the influence of vitamin D status on disease progression and patient survival remains largely unknown for patients with advanced or metastatic colorectal cancer.
EXPERIMENTAL DESIGN


We prospectively collected blood samples in 1,041 patients with previously untreated advanced or metastatic colorectal cancer participating in a randomized phase III clinical trial of first-line chemotherapy plus biologic therapy. We examined the association of baseline plasma 25(OH)D levels with overall survival (OS) and progression-free survival (PFS). Cox proportional hazards models were used to calculate hazard ratios (HRs) and confidence intervals (CIs), adjusted for prognostic factors and confounders.
RESULTS


At study entry, 63% of patients were vitamin D deficient (<20 ng/mL) and 31% were vitamin D insufficient (20-<30 ng/mL). Higher 25(OH)D levels were associated with an improvement in OS and PFS ( P   trend  = 0.0009 and 0.03, respectively). Compared with patients in the bottom quintile of 25(OH)D (≤10.8 ng/mL), those in the top quintile (≥24.1 ng/mL) had a multivariable-adjusted HR of 0.66 (95% CI, 0.53-0.83) for OS and 0.81 (95% CI, 0.66-1.00) for PFS. The improved survival associated with higher 25(OH)D levels was consistent across patient subgroups of prognostic patient and tumor characteristics.
CONCLUSIONS


In this large cohort of patients with advanced or metastatic colorectal cancer, higher plasma 25(OH)D levels were associated with improved OS and PFS. Clinical trials assessing the benefit of vitamin D supplementation in patients with colorectal cancer are warranted.",2019,"Higher 25(OH)D levels were associated with an improvement in OS and PFS ( P   trend =0.0009 and 0.03, respectively).","['Patients with Advanced or Metastatic Colorectal Cancer', 'CRC patients', '1,041 patients with previously untreated advanced or metastatic CRC participating in a randomized phase III clinical trial of first-line', 'patients with advanced or metastatic CRC']","['chemotherapy plus biologic therapy', 'vitamin D supplementation']","['colorectal cancer (CRC) risk and improved survival', 'survival', 'Plasma 25-Hydroxyvitamin D Levels and Survival', 'circulating 25-hydroxyvitamin D [25(OH)D] levels', 'OS and PFS', 'Higher 25(OH)D levels', 'baseline plasma 25(OH)D levels with overall survival (OS) and progression-free survival (PFS', 'plasma 25(OH)D levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1096780', 'cui_str': 'Clinical Trial, Phase 3'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0005527', 'cui_str': 'Biologic Therapy'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",1041.0,0.182611,"Higher 25(OH)D levels were associated with an improvement in OS and PFS ( P   trend =0.0009 and 0.03, respectively).","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yuan', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts. chen_yuan@dfci.harvard.edu.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Sato', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Hollis', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Sui', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Niedzwiecki', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Fang-Shu', 'Initials': 'FS', 'LastName': 'Ou', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'I-Wen', 'Initials': 'IW', 'LastName': 'Chang', 'Affiliation': 'Southeast Clinical Oncology Research (SCOR) Consortium, Winston-Salem, North Carolina.'}, {'ForeName': 'Bert H', 'Initials': 'BH', 'LastName': ""O'Neil"", 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Innocenti', 'Affiliation': 'Eshelman School of Pharmacy and Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Blanke', 'Affiliation': ""SWOG Group Chair's Office/Knight Cancer Institute, Oregon Health and Science University, Portland, Oregon.""}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Goldberg', 'Affiliation': 'West Virginia University Cancer Institute, Morgantown, West Virginia.'}, {'ForeName': 'Alan P', 'Initials': 'AP', 'LastName': 'Venook', 'Affiliation': 'Department of Medicine, University of California San Francisco (UCSF) School of Medicine, San Francisco, California.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mayer', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Fuchs', 'Affiliation': 'Yale Cancer Center and Smilow Cancer Hospital, New Haven, Connecticut.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Meyerhardt', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Kimmie', 'Initials': 'K', 'LastName': 'Ng', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-0877']
260,32329089,Daytime masticatory muscle electromyography biofeedback regulates the phasic component of sleep bruxism.,"BACKGROUND


Electromyography (EMG) biofeedback (BF) training is potentially an effective cognitive-behavioural approach to regulate bruxism.
OBJECTIVE


This study examined sleep bruxism regulation by daytime clenching control using a single-channel auditory EMG BF device.
METHODS


Seventeen male subjects (mean age, 24.4 ± 3.1 years; mean ± SD) with self-reported awake/sleep bruxism were recruited and divided into a BF (n = 10) and a control (CO) group (n = 7). All subjects underwent four EMG recording sessions during both daytime and sleep over 3 weeks. During the daytime, in week 2, the BF group received feedback alert signals when excessive EMG activity with certain burst duration was detected while the subjects performed regular daily activities. The CO group underwent EMG recording sessions without receiving any alerts of parafunctional activity. The number of phasic burst events during sleep was compared between the BF and CO groups.
RESULTS


While the number of phasic EMG events was not significantly different between the BF and CO groups at baseline, significantly smaller phasic events were observed in the BF compared to the CO group at the follow-up session (week 3) (P = .006, Tukey's HSD). Since daytime BF training is aimed at raising awareness of awake bruxism, it does not interrupt the sleep sequence or involve associated side effects.
CONCLUSION


The present results suggest that EMG BF targeting for tonic EMG events during the daytime can be an effective method to regulate phasic EMG events during sleep.",2020,"RESULTS


While the number of phasic EMG events was not significantly different between the BF and CO groups at baseline, significantly smaller phasic and tonic events were observed in the BF compared to the CO group at the follow-up session (week 3)","['Seventeen male subjects (mean age, 24.4 ± 3.1 years; mean ± SD) with self-reported awake/sleep bruxism']","['control (CO', 'Electromyography (EMG) biofeedback (BF) training', 'Daytime Masticatory Muscle Electromyography Biofeedback', 'daytime clenching control using a single-channel auditory EMG BF device', 'EMG BF']","['phasic EMG events', 'smaller phasic and tonic events', 'number of phasic burst events during sleep']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0751771', 'cui_str': 'Nocturnal Teeth Grinding Disorder'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0024890', 'cui_str': 'Structure of muscle of mastication'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0179310', 'cui_str': 'Biofeedback system'}]","[{'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C3543842', 'cui_str': 'TONICS'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0587116', 'cui_str': 'During sleep'}]",17.0,0.0100028,"RESULTS


While the number of phasic EMG events was not significantly different between the BF and CO groups at baseline, significantly smaller phasic and tonic events were observed in the BF compared to the CO group at the follow-up session (week 3)","[{'ForeName': 'Konatsu', 'Initials': 'K', 'LastName': 'Saito-Murakami', 'Affiliation': 'Division of Fixed Prosthodontics, Department of Restorative & Biomaterials Sciences, Meikai University School of Dentistry, Sakado, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Sato', 'Affiliation': 'Division of Fixed Prosthodontics, Department of Restorative & Biomaterials Sciences, Meikai University School of Dentistry, Sakado, Japan.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Otsuka', 'Affiliation': 'Division of Fixed Prosthodontics, Department of Restorative & Biomaterials Sciences, Meikai University School of Dentistry, Sakado, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Miura', 'Affiliation': 'Division of Fixed Prosthodontics, Department of Restorative & Biomaterials Sciences, Meikai University School of Dentistry, Sakado, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Terada', 'Affiliation': 'Department of Biomedical Engineering, Faculty of Science and Engineering, Toyo University, Kawagoe, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Fujisawa', 'Affiliation': 'Division of Fixed Prosthodontics, Department of Restorative & Biomaterials Sciences, Meikai University School of Dentistry, Sakado, Japan.'}]",Journal of oral rehabilitation,['10.1111/joor.12979']
261,31499528,Menopausal Estrogen-Alone Therapy and Health Outcomes in Women With and Without Bilateral Oophorectomy: A Randomized Trial.,"Background


Whether health outcomes of menopausal estrogen therapy differ between women with and without bilateral salpingo-oophorectomy (BSO) is unknown.
Objective


To examine estrogen therapy outcomes by BSO status, with additional stratification by 10-year age groups.
Design


Subgroup analyses of the randomized Women's Health Initiative Estrogen-Alone Trial. (ClinicalTrials.gov: NCT00000611).
Setting


40 U.S. clinical centers.
Participants


9939 women aged 50 to 79 years with prior hysterectomy and known oophorectomy status.
Intervention


Conjugated equine estrogens (CEE) (0.625 mg/d) or placebo for a median of 7.2 years.
Measurements


Incidence of coronary heart disease and invasive breast cancer (the trial's 2 primary end points), all-cause mortality, and a ""global index"" (these end points plus stroke, pulmonary embolism, colorectal cancer, and hip fracture) during the intervention phase and 18-year cumulative follow-up.
Results


The effects of CEE alone did not differ significantly according to BSO status. However, age modified the effect of CEE in women with prior BSO. During the intervention phase, CEE was significantly associated with a net adverse effect (hazard ratio for global index, 1.42 [95% CI, 1.09 to 1.86]) in older women (aged ≥70 years), but the global index was not elevated in younger women (P trend by age = 0.016). During cumulative follow-up, women aged 50 to 59 years with BSO had a treatment-associated reduction in all-cause mortality (hazard ratio, 0.68 [CI, 0.48 to 0.96]), whereas older women with BSO had no reduction (P trend by age = 0.034). There was no significant association between CEE and outcomes among women with conserved ovaries, regardless of age.
Limitations


The timing of CEE in relation to BSO varied; several comparisons were made without adjustment for multiple testing.
Conclusion


The effects of CEE did not differ by BSO status in the overall cohort, but some findings varied by age. Among women with prior BSO, in those aged 70 years or older, CEE led to adverse effects during the treatment period, whereas women randomly assigned to CEE before age 60 seemed to derive mortality benefit over the long term.
Primary Funding Source


The WHI program is funded by the National Heart, Lung, and Blood Institute; National Institutes of Health; and U.S. Department of Health and Human Services. Wyeth Ayerst donated the study drugs.",2019,"The effects of CEE did not differ by BSO status in the overall cohort, but some findings varied by age.","['women with prior BSO', 'women aged 50 to 79 years with prior hysterectomy and known oophorectomy status', 'Participants\n\n\n9939', 'women with and without bilateral salpingo-oophorectomy (BSO', 'women with prior BSO, in those aged 70 years or older, CEE', 'Women']","['Intervention\n\n\nConjugated equine estrogens (CEE', 'Bilateral Oophorectomy', 'Menopausal Estrogen-Alone Therapy', 'CEE', 'placebo', 'menopausal estrogen therapy']","['global index', 'cause mortality', 'BSO status', 'coronary heart disease and invasive breast cancer', 'mortality benefit', 'cause mortality, and a ""global index"" (these end points plus stroke, pulmonary embolism, colorectal cancer, and hip fracture']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0029936', 'cui_str': 'Oophorectomy'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0195495', 'cui_str': 'Bilateral salpingectomy with oophorectomy (procedure)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0046018', 'cui_str': 'CEES'}]","[{'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0046018', 'cui_str': 'CEES'}, {'cui': 'C0278321', 'cui_str': 'Castration, Female'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0279494'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}]",,0.296687,"The effects of CEE did not differ by BSO status in the overall cohort, but some findings varied by age.","[{'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts (J.E.M., S.S.B.).""}, {'ForeName': 'Aaron K', 'Initials': 'AK', 'LastName': 'Aragaki', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington (A.K.A., G.L.A., R.L.P.).'}, {'ForeName': 'Shari S', 'Initials': 'SS', 'LastName': 'Bassuk', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts (J.E.M., S.S.B.).""}, {'ForeName': 'Rowan T', 'Initials': 'RT', 'LastName': 'Chlebowski', 'Affiliation': 'City of Hope National Medical Center, Duarte, and Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, California (R.T.C.).'}, {'ForeName': 'Garnet L', 'Initials': 'GL', 'LastName': 'Anderson', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington (A.K.A., G.L.A., R.L.P.).'}, {'ForeName': 'Jacques E', 'Initials': 'JE', 'LastName': 'Rossouw', 'Affiliation': 'National Heart, Lung, and Blood Institute, Bethesda, Maryland (J.E.R.).'}, {'ForeName': 'Barbara V', 'Initials': 'BV', 'LastName': 'Howard', 'Affiliation': 'MedStar Health Research Institute, Bonita Springs, Florida, and Georgetown-Howard Universities, Washington, DC (B.V.H.).'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Thomson', 'Affiliation': 'Mel & Enid Zuckerman College of Public Health, University of Arizona, Tucson, Arizona (C.A.T.).'}, {'ForeName': 'Marcia L', 'Initials': 'ML', 'LastName': 'Stefanick', 'Affiliation': 'Stanford Prevention Research Center, Stanford, California (M.L.S.).'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Kaunitz', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida (A.M.K.).'}, {'ForeName': 'Carolyn J', 'Initials': 'CJ', 'LastName': 'Crandall', 'Affiliation': 'David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, California (C.J.C.).'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Eaton', 'Affiliation': 'Alpert Medical School of Brown University, Providence, Rhode Island (C.B.E., S.L.).'}, {'ForeName': 'Victor W', 'Initials': 'VW', 'LastName': 'Henderson', 'Affiliation': 'Stanford University, Stanford, California (V.W.H.).'}, {'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Alpert Medical School of Brown University, Providence, Rhode Island (C.B.E., S.L.).'}, {'ForeName': 'Juhua', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'Brown University, Providence, Rhode Island; Indiana University, Bloomington, Indiana (J.L.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rohan', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, New York (T.R.).'}, {'ForeName': 'Aladdin H', 'Initials': 'AH', 'LastName': 'Shadyab', 'Affiliation': 'University of California, San Diego School of Medicine, La Jolla, California (A.H.S.).'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Wells', 'Affiliation': 'University of Kentucky, Lexington, Kentucky (G.W.).'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Wactawski-Wende', 'Affiliation': 'University at Buffalo, the State University of New York, Buffalo, New York (J.W.).'}, {'ForeName': 'Ross L', 'Initials': 'RL', 'LastName': 'Prentice', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington (A.K.A., G.L.A., R.L.P.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of internal medicine,['10.7326/M19-0274']
262,30858518,Lithium continuation therapy following ketamine in patients with treatment resistant unipolar depression: a randomized controlled trial.,"The N-methyl-D-aspartate (NMDA) receptor antagonist ketamine is associated with rapid but transient antidepressant effects in patients with treatment resistant unipolar depression (TRD). Based on work suggesting that ketamine and lithium may share overlapping mechanisms of action, we tested lithium compared to placebo as a continuation strategy following ketamine in subjects with TRD. Participants who met all eligibility criteria and showed at least an initial partial response to a single intravenous infusion of ketamine 0.5 mg/kg were randomized under double-blind conditions to lithium or matching placebo before receiving an additional three infusions of ketamine. Subsequent to the ketamine treatments, participants remained on lithium or placebo during a double-blind continuation phase. The primary study outcome was depression severity as measured by the Montgomery-Åsberg Depression Rating Scale compared between the two groups at Study Day 28, which occurred ~2 weeks following the final ketamine of four infusions. Forty-seven participants with TRD were enrolled in the study and underwent an initial ketamine infusion, of whom 34 participants were deemed to have at least a partial antidepressant response and were eligible for randomization. Comparison between treatment with daily oral lithium (n = 18) or matching placebo (n = 16) at the primary outcome showed no difference in depression severity between groups (t 32  = 0.11, p = 0.91, 95% CI [-7.87, 8.76]). There was no difference between lithium and placebo in continuing the acute antidepressant response to ketamine. The identification of a safe and effective strategy for preventing depression relapse following an acute course of ketamine treatment remains an important goal for future studies.",2019,There was no difference between lithium and placebo in continuing the acute antidepressant response to ketamine.,"['Participants who met all eligibility criteria and showed at least an initial partial response to a single intravenous infusion of ketamine 0.5\u2009mg/kg', 'subjects with TRD', 'patients with treatment resistant unipolar depression (TRD', 'patients with treatment resistant unipolar depression', 'Forty-seven participants with TRD were enrolled in the study and underwent an initial ketamine infusion, of whom 34 participants were deemed to have at least a partial antidepressant response and were eligible for randomization']","['ketamine', 'matching placebo', 'ketamine and lithium', 'placebo', 'lithium or placebo', 'daily oral lithium', 'N-methyl-D-aspartate (NMDA) receptor antagonist ketamine', 'Lithium continuation therapy', 'lithium and placebo', 'lithium or matching placebo']","['depression severity', 'depression severity as measured by the Montgomery-Åsberg Depression Rating Scale']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0041696', 'cui_str': 'Unipolar Depression'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3540800', 'cui_str': 'Lithium'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4521484', 'cui_str': 'N-methyl-D-aspartate receptor antagonist (disposition)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}]",34.0,0.668127,There was no difference between lithium and placebo in continuing the acute antidepressant response to ketamine.,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Costi', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Laili', 'Initials': 'L', 'LastName': 'Soleimani', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Glasgow', 'Affiliation': 'Department of Anesthesiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Jess', 'Initials': 'J', 'LastName': 'Brallier', 'Affiliation': 'Department of Anesthesiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Spivack', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Jaclyn', 'Initials': 'J', 'LastName': 'Schwartz', 'Affiliation': 'Department of Psychology, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Cara F', 'Initials': 'CF', 'LastName': 'Levitch', 'Affiliation': 'Department of Psychology, Fordham University, Bronx, NY, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Richards', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Hoch', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Wade', 'Affiliation': 'Department of Psychology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Welch', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Collins', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Feder', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Dan V', 'Initials': 'DV', 'LastName': 'Iosifescu', 'Affiliation': 'New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Dennis S', 'Initials': 'DS', 'LastName': 'Charney', 'Affiliation': 'Department of Neuroscience, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Murrough', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA. james.murrough@mssm.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0365-0']
263,30926955,"Effects of liraglutide on appetite, food preoccupation, and food liking: results of a randomized controlled trial.","BACKGROUND


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


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


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


Consistent with short-term studies, IBT-liraglutide participants reported greater improvements in hunger, fullness, and food preoccupation than those assigned to IBT-alone. Differences in appetite persisted for 24 weeks but were not maintained at week 52, despite the relatively greater weight losses in the liraglutide-treated participants at the trial's end.",2020,"Multi-component participants reported reduced liking of meals relative to the IBT-alone and IBT-liraglutide groups through weeks 40 and 52, respectively.","['113 adults with obesity (76.1% female, 55.8% white, BMI\u2009=\u200938.8\u2009±\u20094.8\u2009kg/m 2 ) who participated in a 52-week trial']","['intensive behavioral therapy alone (IBT-alone), IBT with liraglutide 3.0\u2009mg/day (IBT-liraglutide), or IBT-liraglutide combined with a 12-week meal replacement diet (Multi-component', 'IBT-alone, IBT-liraglutide', 'IBT-alone and Multi-component', 'IBT-liraglutide', 'liraglutide']","['hunger, fullness, and food preoccupation', 'liking of meals relative', 'hunger, fullness after meals, liking of meals, and food preoccupation', 'fullness', 'weight losses', 'food preoccupation', 'appetite', 'visual analogue scales', 'appetite, food preoccupation, and food liking']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C4517765', 'cui_str': '4.8 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0549165', 'cui_str': 'Preoccupation with ideas'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",113.0,0.0597185,"Multi-component participants reported reduced liking of meals relative to the IBT-alone and IBT-liraglutide groups through weeks 40 and 52, respectively.","[{'ForeName': 'Jena Shaw', 'Initials': 'JS', 'LastName': 'Tronieri', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. jena.tronieri@pennmedicine.upenn.edu.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Walsh', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Robert I', 'Initials': 'RI', 'LastName': 'Berkowitz', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Naji', 'Initials': 'N', 'LastName': 'Alamuddin', 'Affiliation': 'Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Gruber', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Leonard', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Zayna M', 'Initials': 'ZM', 'LastName': 'Bakizada', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Ariana M', 'Initials': 'AM', 'LastName': 'Chao', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}]",International journal of obesity (2005),['10.1038/s41366-019-0348-6']
264,32294503,Clinical features and outcomes of pregnant women suspected of coronavirus disease 2019.,"BACKGROUND


2019 novel coronavirus disease (COVID-19) has become a worldwide pandemic. Under such circumstance pregnant women are also affected significantly.
OBJECTIVE


This study aims to observe the clinical features and outcomes of pregnant women who have been confirmed with COVID-19.
METHODS


The research objects were 55 cases of suspected COVID-19 pregnant women who gave a birth from Jan 20th 2020 to Mar 5th 2020 in our hospital-a big birth center delivering about 30,000 babies in the last 3 years. These cases were subjected to pulmonary CT scan and routine blood test, manifested symptoms of fever, cough, chest tightness or gastrointestinal symptoms. They were admitted to an isolated suite, with clinical features and newborn babies being carefully observed. Among the 55 cases, 13 patients were assigned into the confirmed COVID-19 group for being tested positive sever acute respiratory syndrome coronavirus 2(SARS-CoV-2) via maternal throat swab test, and the other 42 patients were assigned into the control group for being ruled out COVID-19 pneumonia based on new coronavirus pneumonia prevention and control program(the 7th edition).
RESULTS


There were 2 fever patients during the prenatal period and 8 fever patients during the postpartum period in the confirmed COVID-19 group. In contrast, there were 11 prenatal fever patients and 20 postpartum fever patients in the control group (p>0.05). Among 55 cases, only 2 case had cough in the confirmed group. The imaging of pulmonary CT scan showed ground- glass opacity (46.2%, 6/13), patch-like shadows(38.5%, 5/13), fiber shadow(23.1%, 3/13), pleural effusion (38.5%, 5/13)and pleural thickening(7.7%, 1/13), and there was no statistical difference between the confirmed COVID-19 group and the control group (p>0.05). During the prenatal and postpartum period, there was no difference in the count of WBC, Neutrophils and Lymphocyte, the radio of Neutrophils and Lymphocyte and the level of CRP between the confirmed COVID-19 group and the control group(p<0.05). 20 babies (from confirmed mother and from normal mother) were subjected to SARS-CoV-2 examination by throat swab samples in 24 h after birth and no case was tested positive.
CONCLUSION


The clinical symptoms and laboratory indicators are not obvious for asymptomatic and mild COVID-19 pregnant women. Pulmonary CT scan plus blood routine examination are more suitable for finding pregnancy women with asymptomatic or mild COVID-19 infection, and can be used screening COVID-19 pregnant women in the outbreak area of COVID-19 infection.",2020,"During the prenatal and postpartum period, there was no difference in the count of WBC, Neutrophils and Lymphocyte, the radio of Neutrophils and Lymphocyte and the level of CRP between the confirmed COVID-19 group and the control group(p<0.05).","['Pregnant Women Suspected of Coronavirus Disease 2019', 'mild COVID-19 pregnant women', 'pregnant women who have been confirmed with COVID-19', '55 cases of suspected COVID-19 pregnant women who gave a birth from Jan 20th 2020 to Mar 5th 2020 in our hospital-a big birth center delivering about 30,000 babies in the last 3 years', '20 babies (from confirmed mother and from normal mother', '55 cases, 13 patients were assigned into the confirmed COVID-19 group for being tested positive sever acute respiratory syndrome coronavirus 2(SARS-CoV-2) via maternal throat swab test, and the other 42 patients']","['Pulmonary CT scan plus blood routine examination', 'control group for being ruled out COVID-19 pneumonia based on new coronavirus pneumonia prevention and control program(the 7th edition']","['ground- glass opacity', 'pulmonary CT scan and routine blood test, manifested symptoms of fever, cough, chest tightness or gastrointestinal symptoms', 'count of WBC, Neutrophils and Lymphocyte, the radio of Neutrophils and Lymphocyte and the level of CRP', 'pleural effusion']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0024782', 'cui_str': 'Marathi language'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0085142', 'cui_str': 'Birth Centers'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0264097', 'cui_str': 'Calcaneal apophysitis'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0439056', 'cui_str': 'Throat swab'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0441792', 'cui_str': 'Editions'}]","[{'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0029053', 'cui_str': 'Decreased translucency'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0232292', 'cui_str': 'Tight chest'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0034546', 'cui_str': 'Radio'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0032227', 'cui_str': 'Pleural effusion'}]",42.0,0.0506724,"During the prenatal and postpartum period, there was no difference in the count of WBC, Neutrophils and Lymphocyte, the radio of Neutrophils and Lymphocyte and the level of CRP between the confirmed COVID-19 group and the control group(p<0.05).","[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Obstetrics, Maternal and Child Health Hospital of Hubei Province, Tongji Medical College, Huazhong University of Science and Technology, No. 745, Wuluo Road, Hongshan District, Wuhan 430070, China. Electronic address: keaiyh@163.com.'}, {'ForeName': 'Guoqiang', 'Initials': 'G', 'LastName': 'Sun', 'Affiliation': 'Department of Obstetrics, Maternal and Child Health Hospital of Hubei Province, Tongji Medical College, Huazhong University of Science and Technology, No. 745, Wuluo Road, Hongshan District, Wuhan 430070, China. Electronic address: sunguoqiang@hbfy.com.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Tang', 'Affiliation': 'Department of Obstetrics, Maternal and Child Health Hospital of Hubei Province, Tongji Medical College, Huazhong University of Science and Technology, No. 745, Wuluo Road, Hongshan District, Wuhan 430070, China. Electronic address: tangfei87169226@163.com.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Peng', 'Affiliation': 'Department of Obstetrics, Maternal and Child Health Hospital of Hubei Province, Tongji Medical College, Huazhong University of Science and Technology, No. 745, Wuluo Road, Hongshan District, Wuhan 430070, China. Electronic address: pm19751023@163.com.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Obstetrics, Maternal and Child Health Hospital of Hubei Province, Tongji Medical College, Huazhong University of Science and Technology, No. 745, Wuluo Road, Hongshan District, Wuhan 430070, China. Electronic address: gaoying123114@163.com.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Peng', 'Affiliation': 'Department of Obstetrics, Maternal and Child Health Hospital of Hubei Province, Tongji Medical College, Huazhong University of Science and Technology, No. 745, Wuluo Road, Hongshan District, Wuhan 430070, China. Electronic address: 15670513217@163.com.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Department of Radiology, Maternal and Child Health Hospital of Hubei Province, Tongji Medical College, Huazhong University of Science and Technology, No. 745, Wuluo Road, Hongshan District, Wuhan 430070, China. Electronic address: 1165557196@qq.com.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Obstetrics, Maternal and Child Health Hospital of Hubei Province, Tongji Medical College, Huazhong University of Science and Technology, No. 745, Wuluo Road, Hongshan District, Wuhan 430070, China. Electronic address: zhao020060@163.com.'}, {'ForeName': 'Zhichun', 'Initials': 'Z', 'LastName': 'Jin', 'Affiliation': 'Department of prenatal diagnosis, Maternal and Child Health Hospital of Hubei Province, Tongji Medical College, Huazhong University of Science and Technology, No. 745, Wuluo Road, Hongshan District, Wuhan 430070, China. Electronic address: jzc88@163.com.'}]",The Journal of infection,['10.1016/j.jinf.2020.04.003']
265,32281113,Comparison of proximal and distal corticosteroid injections for carpal tunnel syndrome.,"INTRODUCTION


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


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


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


Corticosteroid injections for CTS distal to the wrist are not inferior to proximal injections, yet they are more painful.",2020,"Pain was lower in the proximal than distal group Discussion Corticosteroid injections for CTS distal to the wrist are not inferior to proximal injections, but are more painful.","['131 wrists with CTS', 'carpal tunnel syndrome']","['methylprednisolone', 'placebo', 'proximal and distal corticosteroid injections', 'proximal injection', 'distal corticosteroid injection']","['CTS symptom severity scale (SSS', 'difference in SSS at 3 months, functional status scale (FSS', 'Pain', 'pain of injections']","[{'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}]","[{'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]",131.0,0.175168,"Pain was lower in the proximal than distal group Discussion Corticosteroid injections for CTS distal to the wrist are not inferior to proximal injections, but are more painful.","[{'ForeName': 'Pradeep Pankajakshan', 'Initials': 'PP', 'LastName': 'Nair', 'Affiliation': 'Department of Neurology, Jawaharlal Institute of Postgraduate Medical Education, Pondicherry, India.'}, {'ForeName': 'Vaibhav', 'Initials': 'V', 'LastName': 'Wadwekar', 'Affiliation': 'Department of Neurology, Jawaharlal Institute of Postgraduate Medical Education, Pondicherry, India.'}, {'ForeName': 'Sunitha Vellathussery', 'Initials': 'SV', 'LastName': 'Chakkalakkoombil', 'Affiliation': 'Department of Radiodiagnosis, Jawaharlal Institute of Postgraduate Medical Education, Pondicherry, India.'}, {'ForeName': 'Sunil K', 'Initials': 'SK', 'LastName': 'Narayan', 'Affiliation': 'Department of Neurology, Jawaharlal Institute of Postgraduate Medical Education, Pondicherry, India.'}, {'ForeName': 'Revanth', 'Initials': 'R', 'LastName': 'Marusani', 'Affiliation': 'Department of Neurology, Jawaharlal Institute of Postgraduate Medical Education, Pondicherry, India.'}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Murgai', 'Affiliation': 'Department of Neurology, Jawaharlal Institute of Postgraduate Medical Education, Pondicherry, India.'}, {'ForeName': 'Sibi', 'Initials': 'S', 'LastName': 'Thirunavukkarasu', 'Affiliation': 'Department of Neurology, Jawaharlal Institute of Postgraduate Medical Education, Pondicherry, India.'}, {'ForeName': 'Amritha', 'Initials': 'A', 'LastName': 'Krishnamoorthy', 'Affiliation': 'Department of Neurology, Jawaharlal Institute of Postgraduate Medical Education, Pondicherry, India.'}, {'ForeName': 'Harichandrakumar Kottyen', 'Initials': 'HK', 'LastName': 'Thazhath', 'Affiliation': 'Department of Medical Biometrics and Informatics, Jawaharlal Institute of Postgraduate Medical Education, Pondicherry, India.'}]",Muscle & nerve,['10.1002/mus.26886']
266,31125079,Favorable Changes in Biomarkers of Potential Harm to Reduce the Adverse Health Effects of Smoking in Smokers Switching to the Menthol Tobacco Heating System 2.2 for 3 Months (Part 2).,"INTRODUCTION


Tobacco Heating System (THS) 2.2, a candidate modified-risk tobacco product, aims at offering an alternative to cigarettes for smokers while substantially reducing the exposure to harmful and potentially harmful constituents found in cigarette smoke.
METHODS


One hundred and sixty healthy adult US smokers participated in this randomized, three-arm parallel group, controlled clinical study. Subjects were randomized in a 2:1:1 ratio to menthol Tobacco Heating System 2.2 (mTHS), menthol cigarette, or smoking abstinence for 5 days in confinement and 86 subsequent ambulatory days. Endpoints included biomarkers of exposure to harmful and potentially harmful constituents (reported in our co-publication, Part 1) and biomarkers of potential harm (BOPH).
RESULTS


Compliance (protocol and allocated product exposure) was 51% and 18% in the mTHS and smoking abstinence arms, respectively, on day 90. Nonetheless, favorable changes in BOPHs of lipid metabolism (total cholesterol and high- and low-density cholesterol), endothelial dysfunction (soluble intercellular adhesion molecule-1), oxidative stress (8-epi-prostaglandin F2α), and cardiovascular risk factors (eg, high-sensitivity C-reactive protein) were observed in the mTHS group. Favorable effects in other BOPHs, including ones related to platelet activation (11-dehydrothromboxane B2) and metabolic syndrome (glucose), were more pronounced in normal weight subjects.
CONCLUSIONS


The results suggest that the reduced exposure demonstrated when switching to mTHS is associated with overall improvements in BOPHs, which are indicative of pathomechanistic pathways underlying the development of smoking-related diseases, with some stronger effects in normal weight subjects.
IMPLICATIONS


Switching to mTHS was associated with favorable changes for some BOPHs indicative of biological pathway alterations (eg, oxidative stress and endothelial dysfunction). The results suggest that switching to mTHS has the potential to reduce the adverse health effects of smoking and ultimately the risk of smoking-related diseases. Switching to mTHS for 90 days led to reductions in a number of biomarkers of exposure in smokers, relative to those who continued smoking cigarettes, which were close to those observed when stopping smoking (reported in our co-publication, Part 1). Initial findings suggest reduced levels of 8-epi-prostaglandin F2α and intercellular adhesion molecule 1, when switching to mTHS for 90 days. These changes are comparable to what is observed upon smoking cessation. In normal weight subjects, additional favorable changes were seen in 11-dehydrothromboxane B2, fibrinogen, homocysteine, hs-CRP, percentage of predicted forced expiratory volume in 1 second, systolic blood pressure, diastolic blood pressure, glucose, high-density lipoprotein, apolipoprotein A1, and triglycerides.
TRIAL REGISTRATION


NCT01989156.",2020,"RESULTS


Compliance (protocol and allocated product exposure) was 51% and 18% in the mTHS and SA arms, respectively, on Day 90.",['One hundred and sixty healthy adult U.S. smokers'],"['menthol THS 2.2 (mTHS), menthol cigarette, or smoking abstinence (SA', 'Tobacco Heating System (THS']","['platelet activation (11-dehydrothromboxane B2) and metabolic syndrome (glucose', 'biomarkers of exposure to HPHCs (reported in our co-publication, Part 1) and biomarkers of potential harm (BOPH', 'BOPHs of lipid metabolism (total cholesterol and high- and low-density cholesterol), endothelial dysfunction (soluble intercellular adhesion molecule1), oxidative stress (8-epi-prostaglandin F2α), and cardiovascular risk factors (e.g., high-sensitivity C-reactive protein']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0018851', 'cui_str': 'Heating'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0032173', 'cui_str': 'Platelet Activation'}, {'cui': 'C0044728', 'cui_str': 'Thromboxa-5,13-dien-1-oic acid, 9,15-dihydroxy-11-oxo-, (5Z,9alpha,13E,15S)-'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0034036', 'cui_str': 'Publications'}, {'cui': 'C0449719', 'cui_str': 'Part (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0267963', 'cui_str': 'Pancreatic Insufficiency'}, {'cui': 'C0356622', 'cui_str': 'Prostaglandins, oxytocics'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]",160.0,0.0207686,"RESULTS


Compliance (protocol and allocated product exposure) was 51% and 18% in the mTHS and SA arms, respectively, on Day 90.","[{'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Haziza', 'Affiliation': 'PMI Research and Development, Philip Morris Products S.A., Neuchâtel, Switzerland.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'de La Bourdonnaye', 'Affiliation': 'PMI Research and Development, Philip Morris Products S.A., Neuchâtel, Switzerland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Donelli', 'Affiliation': 'PMI Research and Development, Philip Morris Products S.A., Neuchâtel, Switzerland.'}, {'ForeName': 'Dimitra', 'Initials': 'D', 'LastName': 'Skiada', 'Affiliation': 'PMI Research and Development, Philip Morris Products S.A., Neuchâtel, Switzerland.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Poux', 'Affiliation': 'PMI Research and Development, Philip Morris Products S.A., Neuchâtel, Switzerland.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Weitkunat', 'Affiliation': 'PMI Research and Development, Philip Morris Products S.A., Neuchâtel, Switzerland.'}, {'ForeName': 'Gizelle', 'Initials': 'G', 'LastName': 'Baker', 'Affiliation': 'PMI Research and Development, Philip Morris Products S.A., Neuchâtel, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Picavet', 'Affiliation': 'PMI Research and Development, Philip Morris Products S.A., Neuchâtel, Switzerland.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Lüdicke', 'Affiliation': 'PMI Research and Development, Philip Morris Products S.A., Neuchâtel, Switzerland.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz084']
267,31826336,"Early High-Dose Vitamin D 3  for Critically Ill, Vitamin D-Deficient Patients.","BACKGROUND


Vitamin D deficiency is a common, potentially reversible contributor to morbidity and mortality among critically ill patients. The potential benefits of vitamin D supplementation in acute critical illness require further study.
METHODS


We conducted a randomized, double-blind, placebo-controlled, phase 3 trial of early vitamin D 3  supplementation in critically ill, vitamin D-deficient patients who were at high risk for death. Randomization occurred within 12 hours after the decision to admit the patient to an intensive care unit. Eligible patients received a single enteral dose of 540,000 IU of vitamin D 3  or matched placebo. The primary end point was 90-day all-cause, all-location mortality.
RESULTS


A total of 1360 patients were found to be vitamin D-deficient during point-of-care screening and underwent randomization. Of these patients, 1078 had baseline vitamin D deficiency (25-hydroxyvitamin D level, <20 ng per milliliter [50 nmol per liter]) confirmed by subsequent testing and were included in the primary analysis population. The mean day 3 level of 25-hydroxyvitamin D was 46.9±23.2 ng per milliliter (117±58 nmol per liter) in the vitamin D group and 11.4±5.6 ng per milliliter (28±14 nmol per liter) in the placebo group (difference, 35.5 ng per milliliter; 95% confidence interval [CI], 31.5 to 39.6). The 90-day mortality was 23.5% in the vitamin D group (125 of 531 patients) and 20.6% in the placebo group (109 of 528 patients) (difference, 2.9 percentage points; 95% CI, -2.1 to 7.9; P = 0.26). There were no clinically important differences between the groups with respect to secondary clinical, physiological, or safety end points. The severity of vitamin D deficiency at baseline did not affect the association between the treatment assignment and mortality.
CONCLUSIONS


Early administration of high-dose enteral vitamin D 3  did not provide an advantage over placebo with respect to 90-day mortality or other, nonfatal outcomes among critically ill, vitamin D-deficient patients. (Funded by the National Heart, Lung, and Blood Institute; VIOLET ClinicalTrials.gov number, NCT03096314.).",2019,"Early administration of high-dose enteral vitamin D 3  did not provide an advantage over placebo with respect to 90-day mortality or other, nonfatal outcomes among critically ill, vitamin D-deficient patients.","['critically ill, vitamin D-deficient patients who were at high risk for death', 'Of these patients, 1078 had baseline vitamin D deficiency (25-hydroxyvitamin D level, <20 ng per milliliter [50 nmol per liter]) confirmed by subsequent testing and were included in the primary analysis population', '1360 patients were found to be vitamin D-deficient during point-of-care screening and underwent randomization', 'critically ill, vitamin D-deficient patients', 'Critically Ill, Vitamin D-Deficient Patients', 'critically ill patients']","['single enteral dose of 540,000 IU of vitamin D 3  or matched placebo', 'vitamin D supplementation', 'placebo', 'early vitamin D 3  supplementation', 'vitamin D']","['90-day mortality', '90-day mortality or other, nonfatal outcomes', '90-day all-cause, all-location mortality', 'mean day 3 level of 25-hydroxyvitamin D', 'severity of vitamin D deficiency']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439526', 'cui_str': 'per milliliter'}, {'cui': 'C0439191', 'cui_str': 'nmol'}, {'cui': 'C0475211', 'cui_str': 'L'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1304890', 'cui_str': 'Enteral (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}]",1360.0,0.763031,"Early administration of high-dose enteral vitamin D 3  did not provide an advantage over placebo with respect to 90-day mortality or other, nonfatal outcomes among critically ill, vitamin D-deficient patients.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Adit A', 'Initials': 'AA', 'LastName': 'Ginde', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Roy G', 'Initials': 'RG', 'LastName': 'Brower', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Caterino', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Lani', 'Initials': 'L', 'LastName': 'Finck', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Valerie M', 'Initials': 'VM', 'LastName': 'Banner-Goodspeed', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Colin K', 'Initials': 'CK', 'LastName': 'Grissom', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Hayden', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Hough', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Hyzy', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Levitt', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Pauline K', 'Initials': 'PK', 'LastName': 'Park', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Ringwood', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Emanuel P', 'Initials': 'EP', 'LastName': 'Rivers', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Wesley H', 'Initials': 'WH', 'LastName': 'Self', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Nathan I', 'Initials': 'NI', 'LastName': 'Shapiro', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'B Taylor', 'Initials': 'BT', 'LastName': 'Thompson', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Donald M', 'Initials': 'DM', 'LastName': 'Yealy', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Talmor', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}]",The New England journal of medicine,['10.1056/NEJMoa1911124']
268,30722062,Reduction in Exposure to Selected Harmful and Potentially Harmful Constituents Approaching Those Observed Upon Smoking Abstinence in Smokers Switching to the Menthol Tobacco Heating System 2.2 for 3 Months (Part 1).,"INTRODUCTION


The Tobacco Heating System (THS) is a ""heat-not-burn"" tobacco product designed to generate significantly lower levels of harmful and potentially harmful constituents (HPHCs) and present lower risk of harm than cigarettes. This study assessed the exposure reduction to selected HPHCs in smokers switching to menthol Tobacco Heating System (mTHS) 2.2 compared with smokers continuing smoking menthol cigarettes (mCCs) and smoking abstinence (SA) for 5 days in a confined setting, followed by an 86-day ambulatory period.
METHODS


A total of 160 healthy adult US smokers participated in this randomized, three-arm parallel group, controlled clinical study. Biomarkers of exposure to 16 HPHCs were measured in blood and 24-hour urine. Safety was monitored throughout the study. Information was also gathered on product evaluation, product use, subjective effects, and clinical risk markers (co-publication Part 2).
RESULTS


Nicotine uptake was comparable in both exposure groups (mTHS:mCC ratio of 96% on day 90). On day 5, biomarker of exposure levels to other HPHCs were reduced by 51%-96% in the mTHS group compared with the mCC group, and these reductions were sustained for most biomarkers of exposure over ambulatory period. After 90 days of use, the level of satisfaction with mTHS and suppression of urge to smoke were comparable to mCC.
CONCLUSION


Switching from mCCs to mTHS significantly reduced the exposure to HPHCs to levels approaching those observed in subjects who abstained from smoking for the duration of the study.
IMPLICATIONS


This study compared the impact of switching to mTHS on biomarkers of exposure, relative to continued smoking or SA.
CLINICAL SIGNIFICANCE



TRIAL REGISTRATION


NCT01989156 (ClinicalTrials.gov).",2020,"On Day 5, biomarker of exposure levels to other HPHCs were reduced by 51% to 96% in the mTHS group compared with the mCC group, and these reductions were sustained for most biomarkers over the ambulatory period.","['Methods\n\n\nOne hundred sixty healthy adult U.S. smokers', 'smokers switching to menthol THS']","['Harmful Constituents', 'Menthol Tobacco Heating System 2.2', 'Tobacco Heating System (THS', 'mCC']","['Nicotine uptake', 'blood and 24-hour urine', 'biomarker of exposure levels to other HPHCs', 'Smoking Abstinence', 'level of satisfaction with mTHS and suppression of urge to smoke', 'Safety']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}]","[{'cui': 'C0729650', 'cui_str': 'Constituents (substance)'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0018851', 'cui_str': 'Heating'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C4517629', 'cui_str': '2.2'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0005768'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",160.0,0.0221785,"On Day 5, biomarker of exposure levels to other HPHCs were reduced by 51% to 96% in the mTHS group compared with the mCC group, and these reductions were sustained for most biomarkers over the ambulatory period.","[{'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Haziza', 'Affiliation': 'PMI R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'de La Bourdonnaye', 'Affiliation': 'PMI R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Donelli', 'Affiliation': 'PMI R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Poux', 'Affiliation': 'PMI R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.'}, {'ForeName': 'Dimitra', 'Initials': 'D', 'LastName': 'Skiada', 'Affiliation': 'PMI R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Weitkunat', 'Affiliation': 'PMI R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.'}, {'ForeName': 'Gizelle', 'Initials': 'G', 'LastName': 'Baker', 'Affiliation': 'PMI R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Picavet', 'Affiliation': 'PMI R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Lüdicke', 'Affiliation': 'PMI R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz013']
269,31689359,Interventions for prodromal stage of psychosis.,"BACKGROUND


Psychosis is a serious mental condition characterised by a loss of contact with reality. There may be a prodromal period or stage of psychosis, where early signs of symptoms indicating onset of first episode psychosis (FEP) occur. A number of services, incorporating multimodal treatment approaches (pharmacotherapy, psychotherapy and psychosocial interventions), developed worldwide, now focus on this prodromal period with the aim of preventing psychosis in people at risk of developing FEP.
OBJECTIVES


The primary objective is to assess the safety and efficacy of early interventions for people in the prodromal stage of psychosis. The secondary objective is, if possible, to compare the effectiveness of the various different interventions.
SEARCH METHODS


We searched Cochrane Schizophrenia's study-based Register of studies (including trials registers) on 8 June 2016 and 4 August 2017.
SELECTION CRITERIA


All randomised controlled trials (RCTs) evaluating interventions for participants older than 12 years, who had developed a prodromal stage of psychosis.
DATA COLLECTION AND ANALYSIS


Review authors independently inspected citations, selected studies, extracted data, and assessed study quality.
MAIN RESULTS


We included 20 studies with 2151 participants. The studies analysed 13 different comparisons. Group A comparisons explored the absolute effects of the experimental intervention. Group B were comparisons within which we could not be clear whether differential interactive effects were also ongoing. Group C comparisons explored differential effects between clearly distinct treatments. A key outcome for this review was 'transition to psychosis'. For details of other main outcomes please see 'Summary of findings' tables. In Group A (comparisons of absolute effects) we found no clear difference between amino acids and placebo (risk ratio (RR) 0.48 95% confidence interval (CI) 0.08 to 2.98; 2 RCTs, 52 participants; very low-quality evidence). When omega-3 fatty acids were compared to placebo, fewer participants given the omega-3 (10%) transitioned to psychosis compared to the placebo group (33%) during long-term follow-up of seven years (RR 0.24 95% CI 0.09 to 0.67; 1 RCT, 81 participants; low-quality evidence). In Group B (comparisons where complex interactions are probable) and in the subgroup focusing on antipsychotic drugs added to specific care packages, the amisulpiride + needs-focused intervention (NFI) compared to NFI comparison (no reporting of transition to psychosis; 1 RCT, 102 participants; very low-quality evidence) and the olanzapine + supportive intervention compared to supportive intervention alone comparison (RR 0.58 95% CI 0.28 to 1.18; 1 RCT, 60 participants; very low-quality evidence) showed no clear differences between groups. In the second Group B subgroup (cognitive behavioural therapies (CBT)), when CBT + supportive therapy was compared with supportive therapy alone around 8% of participants allocated to the combination of CBT and supportive therapy group transitioned to psychosis during follow-up by 18 months, compared with double that percentage in the supportive therapy alone group (RR 0.45 95% CI 0.23 to 0.89; 2 RCTs, 252 participants; very low-quality evidence). The CBT + risperidone versus CBT + placebo comparison identified no clear difference between treatments (RR 1.02 95% CI 0.39 to 2.67; 1 RCT, 87 participants; very low-quality evidence) and this also applies to the CBT + needs-based intervention (NBI) + risperidone versus NBI comparison (RR 0.75 95% CI 0.39 to 1.46; 1 RCT, 59 participants; very low-quality evidence). Group C (differential effects) also involved six comparisons. The first compared CBT with supportive therapy. No clear difference was found for the 'transition to psychosis' outcome (RR 0.74 95% CI 0.28 to 1.98; 1 RCT, 72 participants; very low-quality evidence). The second subgroup compared CBT + supportive intervention was compared with a NBI + supportive intervention, again, data were equivocal, few and of very low quality (RR 6.32 95% CI 0.34 to 117.09; 1 RCT, 57 participants). In the CBT + risperidone versus supportive therapy comparison, again there was no clear difference between groups (RR 0.76 95% CI 0.28 to 2.03; 1 RCT, 71 participants; very low-quality evidence). The three other comparisons in Group C demonstrated no clear differences between treatment groups. When cognitive training was compared to active control (tablet games) (no reporting of transition to psychosis; 1 RCT, 62 participants; very low quality data), family treatment compared with enhanced care comparison (RR 0.54 95% CI 0.18 to 1.59; 2 RCTs, 229 participants; very low-quality evidence) and integrated treatment compared to standard treatment comparison (RR 0.57 95% CI 0.28 to 1.15; 1 RCT, 79 participants; very low-quality evidence) no effects of any of these approaches was evident.
AUTHORS' CONCLUSIONS


There has been considerable research effort in this area and several interventions have been trialled. The evidence available suggests that omega-3 fatty acids may prevent transition to psychosis but this evidence is low quality and more research is needed to confirm this finding. Other comparisons did not show any clear differences in effect for preventing transition to psychosis but again, the quality of this evidence is very low or low and not strong enough to make firm conclusions.",2019,"The CBT + risperidone versus CBT + placebo comparison identified no clear difference between treatments (RR 1.02 95% CI 0.39 to 2.67; 1 RCT, 87 participants; very low-quality evidence) and this also applies to the CBT + needs-based intervention (NBI) + risperidone versus NBI comparison (RR 0.75 95% CI 0.39 to 1.46; 1 RCT, 59 participants; very low-quality evidence).","['20 studies with 2151 participants', 'participants older than 12 years, who had developed a prodromal stage of psychosis', 'people at risk of developing FEP', 'prodromal stage of psychosis', 'people in the prodromal stage of psychosis', ""Cochrane Schizophrenia's study-based Register of studies (including trials registers) on 8 June 2016 and 4 August 2017""]","['CBT + risperidone', 'CBT + placebo', 'cognitive behavioural therapies (CBT', 'CBT + supportive therapy', 'olanzapine + supportive intervention', 'CBT and supportive therapy', 'multimodal treatment approaches (pharmacotherapy, psychotherapy and psychosocial interventions', 'placebo', 'omega-3 fatty acids']","['safety and efficacy', ""transition to psychosis' outcome""]","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3494361', 'cui_str': 'Prodromal Stage'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0032611', 'cui_str': 'Polytetrafluoroethylene'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0009429', 'cui_str': 'Multimodal Treatment'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}]",252.0,0.277609,"The CBT + risperidone versus CBT + placebo comparison identified no clear difference between treatments (RR 1.02 95% CI 0.39 to 2.67; 1 RCT, 87 participants; very low-quality evidence) and this also applies to the CBT + needs-based intervention (NBI) + risperidone versus NBI comparison (RR 0.75 95% CI 0.39 to 1.46; 1 RCT, 59 participants; very low-quality evidence).","[{'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Bosnjak Kuharic', 'Affiliation': 'University Psychiatric Hospital Vrapče, Bolnicka cesta 32, Zagreb, Grad Zagreb, Croatia, 10000.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Kekin', 'Affiliation': 'Clinical Hospital Centre Zagreb, Department of Psychiatry, Kispaticeva 12, 10 000, Zagreb, Croatia.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Hew', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, Department of Acute Care Psychiatry, Ladywell Unit, University Hospital Lewisham, London, UK.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Rojnic Kuzman', 'Affiliation': 'Clinical Hospital Centre Zagreb, Department of Psychiatry, Kispaticeva 12, 10 000, Zagreb, Croatia.'}, {'ForeName': 'Livia', 'Initials': 'L', 'LastName': 'Puljak', 'Affiliation': 'Catholic University of Croatia, Center for Evidence-Based Medicine and Health Care, Ilica 242, Zagreb, Croatia, 10000.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012236.pub2']
270,31321423,"A Randomized Clinical Trial of Snus Examining the Effect of Complete Versus Partial Cigarette Substitution on Smoking-Related Behaviors, and Biomarkers of Exposure.","INTRODUCTION


This 8-week multisite, randomized controlled trial of snus examined the differential effects of instructions on (1) snus use, (2) smoking and smoking-related measures, and (3) exposure to tobacco-related constituents.
METHOD


US adult daily cigarette smokers (n = 150; 43.3% female; Medianage = 43.5) were recruited from Minneapolis, Minnesota; Columbus and Coshocton, Ohio; and Buffalo, New York. Following a 1-week sampling phase of snus, participants who used at least 7 pouches were randomized to either (1) partial substitution (PS; ""use snus as you like with your cigarettes""), (2) complete substitution (CS; ""avoid cigarettes""), or (3) usual brand cigarettes (UB). Analyses included between-group analyses (eg, PS vs. CS) using Wilcoxon rank sum test of cigarettes per day and snus pouches per day, and a linear mixed model (biomarkers).
RESULTS


Compared to the PS and UB groups, smokers assigned to CS reported greater reductions in cigarettes per day (ps < .001), using more snus pouches per day (p = .02), and more smoke-free days (CS median = 14.5, PS and UB medians = 0, p < .001). In addition, results demonstrated reductions in carbon monoxide (p < .001), total nicotine equivalents (p = .02), and four out of five measured volatile organic compounds (ps < .01) over time among the CS group. Exposure to N'-nitrosonornicotine increased by trial end only among the PS group (p < .04). Phenanthrene tetraol increased among all groups by trial end (p = .02) with no difference between groups.
CONCLUSIONS


Instructions to completely switch from cigarettes to snus resulted in the greatest reduction in cigarettes and exposure to harmful constituents.
IMPLICATIONS


Directly instructing smokers to switch completely to snus, rather than using ad libitum (with no instructions to avoid cigarettes), is necessary for reductions in smoking and subsequent exposure to harmful constituents.",2020,"Phenanthrene tetraol increased among all groups by trial end (p = .02) with no difference between groups.
","['participants who used at least 7 pouches', 'US adult daily cigarette smokers (n = 150; 43.3% female; Medianage = 43.5) were recruited from Minneapolis, Minnesota; Columbus and Coshocton, Ohio; and Buffalo, New York']","[""N'-nitrosonornicotine"", 'partial substitution (PS; ""use snus as you like with your cigarettes""), (2) complete substitution (CS; ""avoid cigarettes""), or (3) usual brand cigarettes (UB', 'Complete Versus Partial Cigarette Substitution']","['Smoking-Related Behaviors, and Biomarkers of Exposure', 'Phenanthrene tetraol', 'total nicotine equivalents', 'carbon monoxide']","[{'cui': 'C4319584', 'cui_str': 'Pouch (unit of presentation)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0028905', 'cui_str': 'Ohio'}, {'cui': 'C1739095', 'cui_str': 'Bos bison'}, {'cui': 'C0027976', 'cui_str': 'New York'}]","[{'cui': 'C0067113', 'cui_str': 'N-nitrosonor-nicotine'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C4288198', 'cui_str': 'Snus'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C3181403', 'cui_str': 'phenanthrene tetraol'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}]",,0.0376759,"Phenanthrene tetraol increased among all groups by trial end (p = .02) with no difference between groups.
","[{'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Meier', 'Affiliation': 'Department of Psychology, University of Wisconsin-Stevens Point, WI.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Lindgren', 'Affiliation': 'Masonic Comprehensive Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Anderson', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Reisinger', 'Affiliation': 'College of Medicine, Ohio State University, Columbus, OH.'}, {'ForeName': 'Kaila J', 'Initials': 'KJ', 'LastName': 'Norton', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, NY.'}, {'ForeName': 'Joni', 'Initials': 'J', 'LastName': 'Jensen', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Strayer', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dick', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Mei-Kuen', 'Initials': 'MK', 'LastName': 'Tang', 'Affiliation': 'Masonic Comprehensive Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Menglan', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Masonic Comprehensive Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Carmella', 'Affiliation': 'Masonic Comprehensive Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Stephen S', 'Initials': 'SS', 'LastName': 'Hecht', 'Affiliation': 'Masonic Comprehensive Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Sharon E', 'Initials': 'SE', 'LastName': 'Murphy', 'Affiliation': 'Masonic Comprehensive Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Masonic Comprehensive Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Stepanov', 'Affiliation': 'Masonic Comprehensive Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': ""O'Connor"", 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, NY.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Shields', 'Affiliation': 'College of Medicine, Ohio State University, Columbus, OH.'}, {'ForeName': 'Dorothy K', 'Initials': 'DK', 'LastName': 'Hatsukami', 'Affiliation': 'Masonic Comprehensive Cancer Center, University of Minnesota, Minneapolis, MN.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz055']
271,31974691,Refining the criteria for immediate total-body CT after severe trauma.,"OBJECTIVES


Initial trauma care could potentially be improved when conventional imaging and selective CT scanning is omitted and replaced by immediate total-body CT (iTBCT) scanning. Because of the potentially increased radiation exposure by this diagnostic approach, proper selection of the severely injured patients is mandatory.
METHODS


In the REACT-2 trial, severe trauma patients were randomized to iTBCT or conventional imaging and selective CT based on predefined criteria regarding compromised vital parameters, clinical suspicion of severe injuries, or high-risk trauma mechanisms in five trauma centers. By logistic regression analysis with backward selection on the 15 study inclusion criteria, a revised set of criteria was derived and subsequently tested for prediction of severe injury and shifts in radiation exposure.
RESULTS


In total, 1083 patients were enrolled with median ISS of 20 (IQR 9-29) and median GCS of 13 (IQR 3-15). Backward logistic regression resulted in a revised set consisting of nine original and one adjusted criteria. Positive predictive value improved from 76% (95% CI 74-79%) to 82% (95% CI 80-85%). Sensitivity decreased by 9% (95% CI 7-11%). The area under the receiver operating characteristics curve remained equal and was 0.80 (95% CI 0.77-0.83), original set 0.80 (95% CI 0.77-0.83). The revised set retains 8.78 mSv (95% CI 6.01-11.56) for 36% of the non-severely injured patients.
CONCLUSIONS


Selection criteria for iTBCT can be reduced from 15 to 10 clinically criteria. This improves the positive predictive value for severe injury and reduces radiation exposure for less severely injured patients.
KEY POINTS


• Selection criteria for iTBCT can be reduced to 10 clinically useful criteria. • This reduces radiation exposure in 36% of less severely injured patients. • Overall discriminative capacity for selection of severely injured patients remained equal.",2020,Positive predictive value improved from 76% (95% CI 74-79%) to 82% (95% CI 80-85%).,"['1083 patients were enrolled with median ISS of 20 (IQR 9-29) and median GCS of 13 (IQR 3-15', 'severe trauma patients']","['iTBCT or conventional imaging and selective CT', 'conventional imaging and selective CT scanning']","['Positive predictive value', 'Sensitivity', 'radiation exposure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation (event)'}]",1083.0,0.196791,Positive predictive value improved from 76% (95% CI 74-79%) to 82% (95% CI 80-85%).,"[{'ForeName': 'Kaij', 'Initials': 'K', 'LastName': 'Treskes', 'Affiliation': 'Trauma Unit, Department of Surgery, Amsterdam University Medical Centers, location AMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands. k.treskes@amsterdamumc.nl.'}, {'ForeName': 'Teun P', 'Initials': 'TP', 'LastName': 'Saltzherr', 'Affiliation': 'Department of Surgery, Haaglanden Medical Center, Lijnbaan 32, 2512 VA, Den Haag, the Netherlands.'}, {'ForeName': 'Michael J R', 'Initials': 'MJR', 'LastName': 'Edwards', 'Affiliation': 'Trauma Unit, Department of Surgery, Radboud University Medical Center, Geert Grooteplein-Zuid 10, 6525 GA, Nijmegen, the Netherlands.'}, {'ForeName': 'Benn J A', 'Initials': 'BJA', 'LastName': 'Beuker', 'Affiliation': 'Trauma Unit, Department of Surgery, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, the Netherlands.'}, {'ForeName': 'Esther M M', 'Initials': 'EMM', 'LastName': 'Van Lieshout', 'Affiliation': ""Trauma Research Unit, Department of Surgery, Erasmus MC, University Medical Center Rotterdam, 's-Gravendijkwal 230, 3015 CE, Rotterdam, the Netherlands.""}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Hohmann', 'Affiliation': 'Department of Radiology and Nuclear Medicine, University of Basel Hospital, Petersgraben, 4031, Basel, Switzerland.'}, {'ForeName': 'Jan S K', 'Initials': 'JSK', 'LastName': 'Luitse', 'Affiliation': 'Trauma Unit, Department of Surgery, Amsterdam University Medical Centers, location AMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'Ludo F M', 'Initials': 'LFM', 'LastName': 'Beenen', 'Affiliation': 'Department of Radiology, Amsterdam University Medical Centers, location AMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Hollmann', 'Affiliation': 'Department of Anaesthesiology, Amsterdam University Medical Centers, location AMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'Marcel G W', 'Initials': 'MGW', 'LastName': 'Dijkgraaf', 'Affiliation': 'Clinical Research Unit/Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam University Medical Centers, location AMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'J Carel', 'Initials': 'JC', 'LastName': 'Goslings', 'Affiliation': 'Trauma Unit, Department of Surgery, Amsterdam University Medical Centers, location AMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European radiology,['10.1007/s00330-019-06503-2']
272,31944869,Exploring Input Parameters in an Expressive Vocabulary Treatment With Late Talkers.,"Purpose The aims of this study were (a) to assess the efficacy of the Vocabulary Acquisition and Usage for Late Talkers (VAULT) treatment and (b) to compare treatment outcomes for expressive vocabulary acquisition in late talkers in 2 conditions: 3 target words/90 doses per word per session versus 6 target words/45 doses per word per session. Method We ran the treatment protocol for 16 sessions with 24 primarily monolingual English-speaking late talkers. We calculated a  d  score for each child, compared treatment to control effect sizes, and assessed the number of words per week children acquired outside treatment. We compared treatment effect sizes of children in the condition of 3 target words/90 doses per word to those in the condition of 6 target words/45 doses per word. We used Bayesian repeated-measures analysis of variance and Bayesian  t  tests to answer our condition-level questions. Results With an average treatment effect size of almost 1.0, VAULT was effective relative to the no-treatment condition. There were no differences between the different dose conditions. Discussion The VAULT protocol was an efficacious treatment that has the potential to increase the spoken vocabulary of late-talking toddlers and provides clinicians some flexibility in terms of number of words targeted and dose number, keeping in mind the interconnectedness of treatment parameters. Supplemental Material https://doi.org/10.23641/asha.11593323.",2020,"The VAULT protocol was an efficacious treatment that has the potential to increase the spoken vocabulary of late-talking toddlers and provides clinicians some flexibility in terms of number of words targeted and dose number, keeping in mind the interconnectedness of treatment parameters.","['16 sessions with 24 primarily monolingual English-speaking late talkers', 'late talkers in 2 conditions']",['Vocabulary Acquisition and Usage for Late Talkers (VAULT'],[],"[{'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}]",[],,0.0318903,"The VAULT protocol was an efficacious treatment that has the potential to increase the spoken vocabulary of late-talking toddlers and provides clinicians some flexibility in terms of number of words targeted and dose number, keeping in mind the interconnectedness of treatment parameters.","[{'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Alt', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, The University of Arizona, Tucson.'}, {'ForeName': 'Heidi M', 'Initials': 'HM', 'LastName': 'Mettler', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, The University of Arizona, Tucson.'}, {'ForeName': 'Jessie A', 'Initials': 'JA', 'LastName': 'Erikson', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, The University of Arizona, Tucson.'}, {'ForeName': 'Cecilia R', 'Initials': 'CR', 'LastName': 'Figueroa', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, The University of Arizona, Tucson.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Etters-Thomas', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, The University of Arizona, Tucson.'}, {'ForeName': 'Genesis D', 'Initials': 'GD', 'LastName': 'Arizmendi', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, The University of Arizona, Tucson.'}, {'ForeName': 'Trianna', 'Initials': 'T', 'LastName': 'Oglivie', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, The University of Arizona, Tucson.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2019_JSLHR-19-00219']
273,31017637,"Association of Rivaroxaban With Thromboembolic Events in Patients With Heart Failure, Coronary Disease, and Sinus Rhythm: A Post Hoc Analysis of the COMMANDER HF Trial.","Importance


Whether anticoagulation benefits patients with heart failure (HF) in sinus rhythm is uncertain. The COMMANDER HF randomized clinical trial evaluated the effects of adding low-dose rivaroxaban to antiplatelet therapy in patients with recent worsening of chronic HF with reduced ejection fraction, coronary artery disease (CAD), and sinus rhythm. Although the primary end point of all-cause mortality, myocardial infarction, or stroke did not differ between rivaroxaban and placebo, there were numerical advantages favoring rivaroxaban for myocardial infarction and stroke.
Objective


To examine whether low-dose rivaroxaban was associated with reduced thromboembolic events in patients enrolled in the COMMANDER HF trial.
Design, Setting, and Participants


Post hoc analysis of the COMMANDER HF multicenter, randomized, double-blind, placebo-controlled trial in patients with CAD and worsening HF. The trial randomized 5022 patients postdischarge from a hospital or outpatient clinic after treatment for worsening HF between September 2013 and October 2017. Patients were required to be receiving standard care for HF and CAD and were excluded for a medical condition requiring anticoagulation or a bleeding history. Patients were randomized in a 1:1 ratio. Analysis was conducted from June 2018 and January 2019.
Intervention


Patients were randomly assigned to receive 2.5 mg of rivaroxaban given orally twice daily or placebo in addition to their standard therapy.
Main Outcomes and Measures


For this post hoc analysis, a thromboembolic composite was defined as either (1) myocardial infarction, ischemic stroke, sudden/unwitnessed death, symptomatic pulmonary embolism, or symptomatic deep venous thrombosis or (2) all of the previous components except sudden/unwitnessed deaths because not all of these are caused by thromboembolic events.
Results


Of 5022 patients, 3872 (77.1%) were men, and the overall mean (SD) age was 66.4 (10.2) years. Over a median (interquartile range) follow-up of 19.6 (11.7-30.8) months, fewer patients assigned to rivaroxaban compared with placebo had a thromboembolic event including sudden/unwitnessed deaths: 328 (13.1%) vs 390 (15.5%) (hazard ratio, 0.83; 95% CI, 0.72-0.96; P = .01). When sudden/unwitnessed deaths were excluded, the results analyzing thromboembolic events were similar: 153 (6.1%) vs 190 patients (7.6%) with an event (hazard ratio, 0.80; 95% CI, 0.64-0.98; P = .04).
Conclusions and Relevance


In this study, thromboembolic events occurred frequently in patients with HF, CAD, and sinus rhythm. Rivaroxaban may reduce the risk of thromboembolic events in this population, but these events are not the major cause of morbidity and mortality in patients with recent worsening of HF for which rivaroxaban had no effect. While consistent with other studies, these results require confirmation in prospective randomized clinical trials.
Trial Registration


ClinicalTrials.gov identifier: NCT01877915.",2019,"Although the primary end point of all-cause mortality, myocardial infarction, or stroke did not differ between rivaroxaban and placebo, there were numerical advantages favoring rivaroxaban for myocardial infarction and stroke.
","['patients with recent worsening of chronic HF with reduced ejection fraction, coronary artery disease (CAD), and sinus rhythm', 'patients with heart failure (HF', '5022 patients postdischarge from a hospital or outpatient clinic after treatment for worsening HF between September 2013 and October 2017', '5022 patients, 3872 (77.1%) were men, and the overall mean (SD) age was 66.4 (10.2) years', 'Patients were required to be receiving standard care for HF and CAD and were excluded for a medical condition requiring anticoagulation or a bleeding history', 'Patients With Heart Failure, Coronary Disease, and Sinus Rhythm', 'patients with CAD and worsening HF', 'patients enrolled in the COMMANDER HF trial']","['rivaroxaban given orally twice daily or placebo', 'rivaroxaban', 'placebo', 'Rivaroxaban']","['thromboembolic composite was defined as either (1) myocardial infarction, ischemic stroke, sudden/unwitnessed death, symptomatic pulmonary embolism, or symptomatic deep venous thrombosis or (2) all of the previous components except sudden/unwitnessed deaths', 'thromboembolic event including sudden/unwitnessed deaths', 'risk of thromboembolic events', 'thromboembolic events', 'myocardial infarction and stroke', 'cause mortality, myocardial infarction, or stroke']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0232201', 'cui_str': 'Coronary sinus rhythm'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C4521843', 'cui_str': 'CDR'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C1276802', 'cui_str': 'Sudden onset'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",5022.0,0.382181,"Although the primary end point of all-cause mortality, myocardial infarction, or stroke did not differ between rivaroxaban and placebo, there were numerical advantages favoring rivaroxaban for myocardial infarction and stroke.
","[{'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Greenberg', 'Affiliation': 'Cardiology Division, Department of Medicine, University of California, San Diego, La Jolla.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Neaton', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Berlin-Brandenburg Center for Regenerative Therapies, Berlin, Germany.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Byra', 'Affiliation': 'Janssen Research and Development, Raritan, New Jersey.'}, {'ForeName': 'John G F', 'Initials': 'JGF', 'LastName': 'Cleland', 'Affiliation': 'Robertson Centre for Biostatistics and Clinical Trials, University of Glasgow, Glasgow, Scotland.'}, {'ForeName': 'Hsiaowei', 'Initials': 'H', 'LastName': 'Deng', 'Affiliation': 'Janssen Research and Development, Raritan, New Jersey.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Fu', 'Affiliation': 'Janssen Research and Development, Spring House, Pennsylvania.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'La Police', 'Affiliation': 'Janssen Research and Development, Raritan, New Jersey.'}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'National Heart Centre Singapore, Singapore.'}, {'ForeName': 'Mandeep R', 'Initials': 'MR', 'LastName': 'Mehra', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Nessel', 'Affiliation': 'Janssen Research and Development, Raritan, New Jersey.'}, {'ForeName': 'Theodore E', 'Initials': 'TE', 'LastName': 'Spiro', 'Affiliation': 'Research and Development, Pharmaceuticals, Thrombosis and Hematology Therapeutic Area, Bayer US, Whippany, New Jersey.'}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'van Veldhuisen', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Vanden Boom', 'Affiliation': 'Janssen Research and Development, Raritan, New Jersey.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': 'Universite de Lorraine, INSERM Unite 1116, Vandoeuvre les Nancy, France.'}]",JAMA cardiology,['10.1001/jamacardio.2019.1049']
274,32304404,Stress Management Training Improves Overall Performance during Critical Simulated Situations: A Prospective Randomized Controlled Trial.,"BACKGROUND


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


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


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


Residents coping with simulated critical situations who have been trained with Tactics to Optimize the Potential showed better overall performance and a decrease in stress level during high-fidelity simulation. The benefits of this stress management training may be explored in actual clinical settings, where a 5-min Tactics to Optimize the Potential reactivation is feasible prior to delivering a specific intervention.",2020,"The overall performance (mean ± SD) was higher in the Tactics to Optimize the Potential group (59 ± 10) as compared with controls ([54 ± 10], difference, 5 [95% CI, 1 to 9]; P = 0.010; effect size, 0.50 [95% CI, 0.16 to 0.91]).","['Residents participating in high-fidelity simulation', '134 residents randomized', 'during Critical Simulated Situations']","['specific training', 'Stress management training', 'Stress Management Training', 'stress management training']","['median Visual Analogue Scale', 'overall performance (mean ± SD', 'stress level, as assessed by the Visual Analogue Scale during simulation', 'stress level', 'Overall Performance', 'overall performance during simulation measured as a composite score (from 0 to 100) combining a specific clinical score with two nontechnical scores (the Ottawa Global Rating Scale and the Team Emergency Assessment Measure scores) rated']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4517565', 'cui_str': '134'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}]",134.0,0.0838857,"The overall performance (mean ± SD) was higher in the Tactics to Optimize the Potential group (59 ± 10) as compared with controls ([54 ± 10], difference, 5 [95% CI, 1 to 9]; P = 0.010; effect size, 0.50 [95% CI, 0.16 to 0.91]).","[{'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Sigwalt', 'Affiliation': 'From the Departments of Anesthesia and Intensive Care, Hospices Civils of Lyon, Lyon, France (F.S., G.P., D.C., J.-J.L., T.R., M.L.) Departments of Anesthesia and Intensive Care, Grenoble Alpes University Hospital, Grenoble, France (J.-N.E.) Institute of Biomedical Research, Armies\' Health Service, Bretigny sur Orge, France (D.C., M.T., F.C.) Desgenettes Hospital, Armies\' Health Service, Lyon, France (M.B.) Seventh Medical Center of the Armies of Lyon, 76th Medical Antenna of Varces, Varces, France (A.G.-L.) Claude Bernard Lyon 1 University, high fidelity medical simulation center (CLESS; Centre Lyonnais d\'Enseignement par Simulation en Santé), SAMSEI, Lyon, France (D.C., J.-J.L., T.R., M.L.) Health Data Department, Hospices Civils of Lyon, Lyon, France (A.D.) Claude Bernard Lyon 1 University, Health Services and Performance Research Lab (EA 7425 HESPER), Lyon, France (A.D., J.-J.L., M.L.) EA 7426 ""Pathophysiology of Injury-Induced Immunosuppression"" (Pi3), Claude Bernard Lyon 1 University-Biomérieux-Hospices Civils of Lyon, Lyon, France (T.R.) Val-de-Grâce School, Paris, France (M.T., F.C.).'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Petit', 'Affiliation': ''}, {'ForeName': 'Jean-Noel', 'Initials': 'JN', 'LastName': 'Evain', 'Affiliation': ''}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Claverie', 'Affiliation': ''}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Bui', 'Affiliation': ''}, {'ForeName': 'Angélique', 'Initials': 'A', 'LastName': 'Guinet-Lebreton', 'Affiliation': ''}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Trousselard', 'Affiliation': ''}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Canini', 'Affiliation': ''}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Chassard', 'Affiliation': ''}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Duclos', 'Affiliation': ''}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Lehot', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rimmelé', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Lilot', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003287']
275,32304405,"Magnesium and Bladder Discomfort after Transurethral Resection of Bladder Tumor: A Randomized, Double-blind, Placebo-controlled Study.","BACKGROUND


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


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


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


Magnesium reduced the incidence of catheter-related bladder discomfort above a moderate grade and increased patient satisfaction among patients having transurethral resection of bladder tumor.",2020,"The incidence of catheter-related bladder discomfort above a moderate grade at 0 h postoperatively was significantly lower in the magnesium group than in the control group (13 [22%] vs. 46 [77%]; P < 0.001; relative risk = 0.283; 95% CI, 0.171 to 0.467; absolute risk reduction = 0.55; number needed to treat = 2); similar results were observed for catheter-related bladder discomfort above a moderate grade at 1 and 2 h postoperatively (5 [8%] vs. 17 [28%]; P = 0.005; relative risk = 0.294; 95% CI, 0.116 to 0.746; and 1 [2%] vs. 14 [23%]; P < 0.001; relative risk = 0.071; 95% CI, 0.010 to 0.526, respectively).","['after Transurethral Resection of Bladder Tumor', '120 patients recovering from transurethral resection of bladder tumor, intravenous', 'patients having transurethral resection of bladder tumor']","['magnesium', 'intravenous magnesium sulfate', 'normal saline', 'Magnesium', 'Placebo', 'Magnesium and Bladder Discomfort']","['patient satisfaction, and magnesium-related adverse effects', 'incidence of catheter-related bladder discomfort above a moderate grade at 0 h postoperatively', 'patient satisfaction', 'Magnesium-related adverse effects', 'bladder discomfort', 'Patient satisfaction', 'catheter-related bladder discomfort', 'mild, moderate, and severe catheter-related bladder discomfort', 'incidence of catheter-related bladder discomfort']","[{'cui': 'C0401496', 'cui_str': 'Transurethral resection of bladder neoplasm'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0549391', 'cui_str': 'Bladder discomfort'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0549391', 'cui_str': 'Bladder discomfort'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",120.0,0.63529,"The incidence of catheter-related bladder discomfort above a moderate grade at 0 h postoperatively was significantly lower in the magnesium group than in the control group (13 [22%] vs. 46 [77%]; P < 0.001; relative risk = 0.283; 95% CI, 0.171 to 0.467; absolute risk reduction = 0.55; number needed to treat = 2); similar results were observed for catheter-related bladder discomfort above a moderate grade at 1 and 2 h postoperatively (5 [8%] vs. 17 [28%]; P = 0.005; relative risk = 0.294; 95% CI, 0.116 to 0.746; and 1 [2%] vs. 14 [23%]; P < 0.001; relative risk = 0.071; 95% CI, 0.010 to 0.526, respectively).","[{'ForeName': 'Jun-Young', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea (J.-Y.P.. D.-H.K., J.Y., J.-H.H., Y.-K.K.) the Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea (J.H.H.).'}, {'ForeName': 'Jun Hyuk', 'Initials': 'JH', 'LastName': 'Hong', 'Affiliation': ''}, {'ForeName': 'Doo-Hwan', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Jihion', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Jai-Hyun', 'Initials': 'JH', 'LastName': 'Hwang', 'Affiliation': ''}, {'ForeName': 'Young-Kug', 'Initials': 'YK', 'LastName': 'Kim', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003309']
276,32323190,Associations between model-predicted rivaroxaban exposure and patient characteristics and efficacy and safety outcomes in the prevention of venous thromboembolism.,"Anticoagulant plasma concentrations and patient characteristics might affect the benefit-risk balance of therapy. The study objective was to assess the impact of model-predicted rivaroxaban exposure and patient characteristics on outcomes in patients receiving rivaroxaban for venous thromboembolism (VTE) prophylaxis (VTE-P) after hip/knee replacement surgery. Post hoc exposure-response analyses were conducted using data from the phase 3 RECORD1-4 studies, in which 12,729 patients were randomized to rivaroxaban 10 mg once daily or enoxaparin for ≤ 39 days. Multivariate regression approaches were used to correlate model-predicted individual rivaroxaban exposures and patient characteristics with outcomes. In the absence of measured rivaroxaban exposure, exposure estimates were predicted based on individual increases in prothrombin time (PT) and by making use of the known correlation between rivaroxaban plasma concentration and dynamics of PT. No significant associations between rivaroxaban exposure and total VTE or major bleeding were identified. A significant association between exposure and a composite of major or non-major clinically relevant (NMCR) bleeding from day 4 after surgery was observed. The relationship was shallow, with an approximate predicted absolute increase in a composite of major or NMCR bleeding from 1.08 [95% confidence interval (CI) 0.76-1.54] to 2.18% (95% CI 1.51-3.17) at the 5th and 95th percentiles of trough plasma concentration, respectively. In conclusion, based on the underlying data and analysis, no reliable target window for exposure with improved benefit-risk could be identified within the investigated exposure range. Hence, monitoring rivaroxaban levels is unlikely to be beneficial in VTE-P.",2020,No significant associations between rivaroxaban exposure and total VTE or major bleeding were identified.,"['12,729 patients', 'patients receiving rivaroxaban for venous thromboembolism (VTE) prophylaxis (VTE-P) after hip/knee replacement surgery']","['rivaroxaban', 'rivaroxaban 10\xa0mg once daily or enoxaparin']","['composite of major or NMCR bleeding', 'prothrombin time (PT', 'rivaroxaban exposure and total VTE or major bleeding', 'composite of major or non-major clinically relevant (NMCR) bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C3162455', 'cui_str': 'rivaroxaban 10 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}]",12729.0,0.076615,No significant associations between rivaroxaban exposure and total VTE or major bleeding were identified.,"[{'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Reinecke', 'Affiliation': 'Bayer AB, Solna, Sweden.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Solms', 'Affiliation': 'Clinical Pharmacometrics, Bayer AG, Berlin, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Willmann', 'Affiliation': 'Clinical Pharmacometrics, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Theodore E', 'Initials': 'TE', 'LastName': 'Spiro', 'Affiliation': 'Bayer U.S., LLC, Research & Development, Pharmaceuticals, 100 Bayer Boulevard, Whippany, NJ, 07981, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Peters', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Jeffrey I', 'Initials': 'JI', 'LastName': 'Weitz', 'Affiliation': 'McMaster University, and the Thrombosis & Atherosclerosis Research Institute, Hamilton, ON, Canada.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Mueck', 'Affiliation': 'Clinical Pharmacokinetics, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Garmann', 'Affiliation': 'Clinical Pharmacometrics, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': 'Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, FL, USA.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Keith A A', 'Initials': 'KAA', 'LastName': 'Fox', 'Affiliation': 'Centre for Cardiovascular Science, The University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Bayer U.S., LLC, Research & Development, Pharmaceuticals, 100 Bayer Boulevard, Whippany, NJ, 07981, USA. scott.berkowitz@bayer.com.'}]",Journal of thrombosis and thrombolysis,['10.1007/s11239-020-02078-8']
277,32323192,Associations between model-predicted rivaroxaban exposure and patient characteristics and efficacy and safety outcomes in patients with non-valvular atrial fibrillation.,"Rivaroxaban exposure and patient characteristics may affect the rivaroxaban benefit-risk balance. This study aimed to quantify associations between model-predicted rivaroxaban exposure and patient characteristics and efficacy and safety outcomes in patients with non-valvular atrial fibrillation (NVAF), using data from the phase 3 ROCKET AF trial (NCT00403767). In ROCKET AF, 14,264 patients with NVAF were randomized to rivaroxaban (20 mg once daily [OD], or 15 mg OD if creatinine clearance was 30-49 mL/min) or dose-adjusted warfarin (median follow-up: 707 days); rivaroxaban plasma concentration was measured in a subset of 161 patients. In this post hoc exposure-response analysis, a multivariate Cox model was used to correlate individual predicted rivaroxaban exposures and patient characteristics with time-to-event efficacy and safety outcomes in 7061 and 7111 patients, respectively. There was no significant association between model-predicted rivaroxaban trough plasma concentration (C trough ) and efficacy outcomes. Creatinine clearance and history of stroke were significantly associated with efficacy outcomes. C trough  was significantly associated with the composite of major or non-major clinically relevant (NMCR) bleeding (hazard ratio [95th percentile vs. median]: 1.26 [95% confidence interval 1.13-1.40]) but not with major bleeding alone. The exposure-response relationship for major or NMCR bleeding was shallow with no clear threshold for an acceleration in risk. History of gastrointestinal bleeding had a greater influence on safety outcomes than C trough . These results support fixed rivaroxaban 15 mg and 20 mg OD dosages in NVAF. Therapeutic drug monitoring is unlikely to offer clinical benefits in this indication beyond evaluation of patient characteristics.",2020,There was no significant association between model-predicted rivaroxaban trough plasma concentration (C trough ) and efficacy outcomes.,"['14,264 patients with NVAF', 'patients with non-valvular atrial fibrillation (NVAF', 'patients with non-valvular atrial fibrillation']","['rivaroxaban', 'Rivaroxaban']","['safety outcomes', 'rivaroxaban trough plasma concentration (C trough ) and efficacy outcomes', 'composite of major or non-major clinically relevant (NMCR) bleeding', 'Creatinine clearance and history of stroke', 'rivaroxaban plasma concentration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",14264.0,0.0632288,There was no significant association between model-predicted rivaroxaban trough plasma concentration (C trough ) and efficacy outcomes.,"[{'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA. LZhang11@ITS.JNJ.com.'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Keith A A', 'Initials': 'KAA', 'LastName': 'Fox', 'Affiliation': 'Centre for Cardiovascular Science, The University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Willmann', 'Affiliation': 'Clinical Pharmacometrics, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Partha', 'Initials': 'P', 'LastName': 'Nandy', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Bayer U.S., LLC, Research & Development, Pharmaceuticals, Whippany, NJ, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Hermanowski-Vosatka', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Jeffrey I', 'Initials': 'JI', 'LastName': 'Weitz', 'Affiliation': 'Thrombosis & Atherosclerosis Research Institute, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Solms', 'Affiliation': 'Clinical Pharmacometrics, Bayer AG, Berlin, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': 'Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, FL, USA.'}, {'ForeName': 'Manesh', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Peters', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}]",Journal of thrombosis and thrombolysis,['10.1007/s11239-020-02077-9']
278,32323462,Peeling with 70% glicolic acid followed by 5% 5-fluorouracil as well as 5% 5-fluorouracil cream are effective methods for the treatment of actinic keratoses on upper limbs: A randomized clinical trial.,"The 5% 5-fluorouracil (5-FU) cream, considered the gold standard topical treatment, and peeling using 70% glycolic acid (GA) followed by 5% 5-FU are methods for the treatment of actinic keratoses (AKs). However, the comparison of these two treatments had not yet been described and therefore was the objective of this study. A randomized clinical trial, intrapatient study in which 17 patients received a type of treatment in the right and left upper limb with 5% 5-FU cream (twice daily) or a peeling application of 70% GA (every 15 days) followed by 5% 5-FU cream. There was a significant reduction of 75% and 85.71% in the mean number of AK lesions and of 74.5% and 85.71% in the size of lesions on the upper limbs of patients treated with peeling and 5% 5-FU cream (P-value ≤.001), respectively. Neither treatment was superior to the other since there was no significant difference (P-value ≥.05) between the treatments, both at the post-intervention period as well as when comparing the difference between the pre and post-intervention periods. The peeling with 70% GA followed by 5% 5-FU as well as 5% 5-FU cream are effective methods for the treatment of AKs on upper limbs.",2020,"There was a significant reduction of 75% and 85.71% in the mean number of AK lesions and of 74.5% and 85.71% in the size of lesions on the upper limbs of patients treated with peeling and 5% 5-FU cream (p-value ≤ 0.001), respectively.","['actinic keratoses on upper limbs', '17 patients received a type of treatment in the right and left upper limb with 5']","['peeling using 70% glycolic acid (GA) followed by 5% 5-FU', '5-fluorouracil (5-FU) cream', '5-FU cream (twice daily) or a peeling application of 70% GA (every 15\u2009days) followed by 5% 5-FU cream', 'Peeling with 70% glicolic acid followed by 5% 5-fluorouracil', '5-fluorouracil cream', '5-FU cream', '5-FU']",['mean number of AK lesions'],"[{'cui': 'C0439681', 'cui_str': 'Actinic'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0237849', 'cui_str': 'Peeling of skin'}, {'cui': 'C1533643', 'cui_str': 'Glycolic acid'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001128', 'cui_str': 'Acid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",,0.0319346,"There was a significant reduction of 75% and 85.71% in the mean number of AK lesions and of 74.5% and 85.71% in the size of lesions on the upper limbs of patients treated with peeling and 5% 5-FU cream (p-value ≤ 0.001), respectively.","[{'ForeName': 'Cristiane L', 'Initials': 'CL', 'LastName': 'Heuser', 'Affiliation': 'Program in Comprehensive Health Care-PPGAIS, a collaboration between the University of Cruz Alta-UNICRUZ and Regional University of the Northwestern of Rio Grande do Sul-UNIJUÍ, RS, Brazil.'}, {'ForeName': 'Guilherme G', 'Initials': 'GG', 'LastName': 'Heuser', 'Affiliation': 'Program in Comprehensive Health Care-PPGAIS, a collaboration between the University of Cruz Alta-UNICRUZ and Regional University of the Northwestern of Rio Grande do Sul-UNIJUÍ, RS, Brazil.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Casagrande', 'Affiliation': 'Regional University of the Northwestern of Rio Grande do Sul-UNIJUÍ, Ijuí, RS, Brazil.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'de Fátima Pavan Zanella', 'Affiliation': 'Program in Comprehensive Health Care-PPGAIS, a collaboration between the University of Cruz Alta-UNICRUZ and Regional University of the Northwestern of Rio Grande do Sul-UNIJUÍ, RS, Brazil.'}, {'ForeName': 'Eliane R', 'Initials': 'ER', 'LastName': 'Winkelmann', 'Affiliation': 'Program in Comprehensive Health Care-PPGAIS, a collaboration between the University of Cruz Alta-UNICRUZ and Regional University of the Northwestern of Rio Grande do Sul-UNIJUÍ, RS, Brazil.'}]",Dermatologic therapy,['10.1111/dth.13459']
279,32324307,"Rationale and design of a smartphone-enabled, home-based exercise program in patients with symptomatic peripheral arterial disease: The smart step randomized trial.","BACKGROUND


Supervised exercise therapy (SET) is recommended in patients with symptomatic peripheral arterial disease (PAD) as first-line therapy, although patient adoption remains low. Home-based exercise therapy (HBET) delivered through smartphones may expand access. The feasibility of such programs, especially in low-resource settings, remains unknown.
METHODS


Smart Step is a pilot randomized trial of smartphone-enabled HBET vs walking advice in patients with symptomatic PAD in an inner-city hospital. Participants receive a smartphone app with daily exercise reminders and educational content. A trained coach performs weekly phone-based coaching sessions. All participants receive a Fitbit Charge HR 2 to measure physical activity. The primary outcome changes in 6-minute walking test (6MWT) distance at 12 weeks over baseline. Secondary outcomes are the degree of engagement with the smartphone app and changes in health behaviors and quality of life scores after 12 weeks and 1 year.
RESULTS


A total of 15 patients are randomized as of December 15, 2019 with a mean (SD) age of 66.1 (5.8) years. The majority are female (60%) and black (87%). At baseline, the mean (SD) ABI and 6MWT were 0.86 (0.29) and 363.5 m, respectively. Enrollment is expected to continue until December 2020 to achieve a target size of 50 participants.
CONCLUSIONS


The potential significance of this trial will be to provide preliminary evidence of a home-based, ""mobile-first"" approach for delivering a structured exercise rehabilitation program. Smartphone-enabled HBET can be potentially more accessible than center-based programs, and if proven effective, may have a potential widespread public health benefit.",2020,"Smartphone-enabled HBET can be potentially more accessible than center-based programs, and if proven effective, may have a potential widespread public health benefit.","['patients with symptomatic peripheral arterial disease', 'patients with symptomatic PAD in an inner-city hospital', 'patients with symptomatic peripheral arterial disease (PAD', '15 patients are randomized as of December 15, 2019 with a mean (SD) age of 66.1 (5.8) years']","['Supervised exercise therapy (SET', 'Fitbit Charge HR', 'smartphone-enabled HBET vs walking advice', 'Home-based exercise therapy (HBET', 'Smartphone-enabled HBET', 'smartphone-enabled, home-based exercise program', 'smartphone app with daily exercise reminders and educational content']","['degree of engagement with the smartphone app and changes in health behaviors and quality of life scores', 'mean (SD) ABI and 6MWT', '6-minute walking test (6MWT) distance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}, {'cui': 'C0557849', 'cui_str': 'Inner city'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1328319', 'cui_str': 'Ankle brachial pressure index'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",,0.172339,"Smartphone-enabled HBET can be potentially more accessible than center-based programs, and if proven effective, may have a potential widespread public health benefit.","[{'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Harzand', 'Affiliation': 'Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Vakili', 'Affiliation': 'Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Alaaeddin', 'Initials': 'A', 'LastName': 'Alrohaibani', 'Affiliation': 'Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Smah M', 'Initials': 'SM', 'LastName': 'Abdelhamid', 'Affiliation': 'Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Neil F', 'Initials': 'NF', 'LastName': 'Gordon', 'Affiliation': 'INTERVENT International, Savannah, Georgia, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Thiel', 'Affiliation': 'INTERVENT International, Savannah, Georgia, USA.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Benarroch-Gampel', 'Affiliation': 'Division of Vascular Surgery, Department of Surgery, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Victoria J', 'Initials': 'VJ', 'LastName': 'Teodorescu', 'Affiliation': 'Division of Vascular Surgery, Department of Surgery, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Keri', 'Initials': 'K', 'LastName': 'Minton', 'Affiliation': 'Grady Memorial Hospital, Atlanta, Georgia, USA.'}, {'ForeName': 'Nanette K', 'Initials': 'NK', 'LastName': 'Wenger', 'Affiliation': 'Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Ravi R', 'Initials': 'RR', 'LastName': 'Rajani', 'Affiliation': 'Division of Vascular Surgery, Department of Surgery, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Amit J', 'Initials': 'AJ', 'LastName': 'Shah', 'Affiliation': 'Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}]",Clinical cardiology,['10.1002/clc.23362']
280,32004687,Immune response to different types of hepatitis B vaccine booster doses 2-32 years after the primary immunization schedule and its influencing factors.,"OBJECTIVE


To assess the immune effect of different types of hepatitis B vaccine (HepB) booster doses 2-32 years after primary immunization, explore the influencing factors, and offer guidance regarding the necessity and timing of boosters.
METHODS


In total, 1163 participants who were born from 1986 to 2015, received the HepB full-course primary vaccination, were hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) negative, and had hepatitis B surface antibody (anti-HBs) <10 mIU/mL were enrolled. Individuals were randomly divided into two groups and received a booster dose of HepB. Venous blood samples were collected 30 days later and tested for anti-HBs.
RESULTS


In total, 595 and 568 individuals received a single dose of HepB (CHO) and HepB (SC), respectively. Venous blood samples were obtained from 1079 vaccinees (CHO: 554, SC: 525). The seroconversion rates were 93.68% (519/554) and 86.67% (455/525) (p < 0.05), with geometric mean concentrations (GMCs) of 426.58 mIU/ml and 223.8 mIU/ml, respectively. This result indicated that BMI, smoking status, vaccine types of booster and prebooster anti-HBs concentration significantly influenced anti-HBs levels. Only BMI, prebooster anti-HBs concentrations and booster types were different between the anti-HBs positive and negative groups.
CONCLUSIONS


Participants boostered with HepB (CHO) had a relatively higher seroconversion rate than those boostered with HepB (SC). The high seroconversion rates in the two groups suggested that the subjects remained protected despite low circulating antibodies, so there is currently no urgent need for booster immunization. Factors including BMI ≥ 25 and prebooster anti-HBs concentration <2.5 mIU/mL, which contributed to lower responses to a booster dose, might indicate a greater risk of breakthrough infection.",2020,"Only BMI, prebooster anti-HBs concentrations and booster types were different between the anti-HBs positive and negative groups.
","['In total, 595 and 568 individuals received a', '1163 participants who were born from 1986 to 2015, received the HepB full-course primary vaccination, were hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) negative, and had hepatitis B surface antibody (anti-HBs) <10 mIU/mL were enrolled']","['hepatitis B vaccine (HepB', 'single dose of HepB (CHO) and HepB (SC', 'hepatitis B vaccine']","['Only BMI, prebooster anti-HBs concentrations and booster types', 'seroconversion rate', 'seroconversion rates', 'BMI\u2009≥\u200925 and prebooster anti-HBs concentration', 'Venous blood samples', 'high seroconversion rates', 'Immune response']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0061073', 'cui_str': 'HPhCA'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0201477', 'cui_str': 'Hepatitis B surface antigen measurement (procedure)'}, {'cui': 'C0201480', 'cui_str': 'Hepatitis B core antibody measurement (procedure)'}, {'cui': 'C0312631', 'cui_str': 'Antibody to hepatitis B core antigen (substance)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0201478', 'cui_str': 'Hepatitis B surface antibody measurement (procedure)'}, {'cui': 'C0369334', 'cui_str': 'Antibody to hepatitis B surface antigen (substance)'}, {'cui': 'C0439457', 'cui_str': 'milliinternational unit/milliliter'}]","[{'cui': 'C0062527', 'cui_str': 'Hepatitis B Surface Antigen Vaccine'}, {'cui': 'C0061073', 'cui_str': 'HPhCA'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0369334', 'cui_str': 'Antibody to hepatitis B surface antigen (substance)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1697762', 'cui_str': 'Booster'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}]",1163.0,0.0274436,"Only BMI, prebooster anti-HBs concentrations and booster types were different between the anti-HBs positive and negative groups.
","[{'ForeName': 'Yu-Liang', 'Initials': 'YL', 'LastName': 'Zhao', 'Affiliation': ""Hebei Province Center for Disease Control and Prevention, 97 Huai'an East Road, Yuhua District, Shijiazhuang 050021, Hebei, People's Republic of China. Electronic address: yuliang_zh1@163.com.""}, {'ForeName': 'Lu-Lu', 'Initials': 'LL', 'LastName': 'Pan', 'Affiliation': ""Hebei Province Center for Disease Control and Prevention, 97 Huai'an East Road, Yuhua District, Shijiazhuang 050021, Hebei, People's Republic of China.""}, {'ForeName': 'Zhi-Yong', 'Initials': 'ZY', 'LastName': 'Hao', 'Affiliation': ""Zhengding County Center for Disease Control and Prevention, Zhengding 050800, Hebei, People's Republic of China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Jin', 'Affiliation': ""Hebei Province Center for Disease Control and Prevention, 97 Huai'an East Road, Yuhua District, Shijiazhuang 050021, Hebei, People's Republic of China.""}, {'ForeName': 'Yan-Hong', 'Initials': 'YH', 'LastName': 'Zhang', 'Affiliation': ""Zhengding County Center for Disease Control and Prevention, Zhengding 050800, Hebei, People's Republic of China.""}, {'ForeName': 'Min-Jie', 'Initials': 'MJ', 'LastName': 'Li', 'Affiliation': ""Hebei Province Center for Disease Control and Prevention, 97 Huai'an East Road, Yuhua District, Shijiazhuang 050021, Hebei, People's Republic of China.""}, {'ForeName': 'Xin-Jiang', 'Initials': 'XJ', 'LastName': 'Zhang', 'Affiliation': ""Zhengding County Center for Disease Control and Prevention, Zhengding 050800, Hebei, People's Republic of China.""}, {'ForeName': 'Bi-Hua', 'Initials': 'BH', 'LastName': 'Han', 'Affiliation': ""Hebei Province Center for Disease Control and Prevention, 97 Huai'an East Road, Yuhua District, Shijiazhuang 050021, Hebei, People's Republic of China.""}, {'ForeName': 'Hai-Song', 'Initials': 'HS', 'LastName': 'Zhou', 'Affiliation': ""Zhengding County Center for Disease Control and Prevention, Zhengding 050800, Hebei, People's Republic of China.""}, {'ForeName': 'Tian-Li', 'Initials': 'TL', 'LastName': 'Ma', 'Affiliation': ""Hebei Province Center for Disease Control and Prevention, 97 Huai'an East Road, Yuhua District, Shijiazhuang 050021, Hebei, People's Republic of China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': ""Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Changing District, 100052 Beijing, People's Republic of China.""}, {'ForeName': 'Jing-Chen', 'Initials': 'JC', 'LastName': 'Ma', 'Affiliation': ""Hebei Province Center for Disease Control and Prevention, 97 Huai'an East Road, Yuhua District, Shijiazhuang 050021, Hebei, People's Republic of China.""}, {'ForeName': 'Li-Peng', 'Initials': 'LP', 'LastName': 'Shen', 'Affiliation': ""Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Changing District, 100052 Beijing, People's Republic of China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ""Hebei Province Center for Disease Control and Prevention, 97 Huai'an East Road, Yuhua District, Shijiazhuang 050021, Hebei, People's Republic of China. Electronic address: liqicdc226@163.com.""}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.01.047']
281,31138020,G-CSF for Extensive STEMI.,"RATIONALE


In the exploratory Phase II STEM-AMI (Stem Cells Mobilization in Acute Myocardial Infarction) trial, we reported that early administration of G-CSF (granulocyte colony-stimulating factor), in patients with anterior ST-segment-elevation myocardial infarction and left ventricular (LV) dysfunction after successful percutaneous coronary intervention, had the potential to significantly attenuate LV adverse remodeling in the long-term.
OBJECTIVE


The STEM-AMI OUTCOME CMR (Stem Cells Mobilization in Acute Myocardial Infarction Outcome Cardiac Magnetic Resonance) Substudy was adequately powered to evaluate, in a population showing LV ejection fraction ≤45% after percutaneous coronary intervention for extensive ST-segment-elevation myocardial infarction, the effects of early administration of G-CSF in terms of LV remodeling and function, infarct size assessed by late gadolinium enhancement, and myocardial strain.
METHODS AND RESULTS


Within the Italian, multicenter, prospective, randomized, Phase III STEM-AMI OUTCOME trial, 161 ST-segment-elevation myocardial infarction patients were enrolled in the CMR Substudy and assigned to standard of care (SOC) plus G-CSF or SOC alone. In 119 patients (61 G-CSF and 58 SOC, respectively), CMR was available at baseline and 6-month follow-up. Paired imaging data were independently analyzed by 2 blinded experts in a core CMR lab. The 2 groups were similar for clinical characteristics, cardiovascular risk factors, and pharmacological treatment, except for a trend towards a larger infarct size and longer symptom-to-balloon time in G-CSF patients. ANCOVA showed that the improvement of LV ejection fraction from baseline to 6 months was 5.1% higher in G-CSF patients versus SOC (P=0.01); concurrently, there was a significant between-group difference of 6.7 mL/m 2  in the change of indexed LV end-systolic volume in favor of G-CSF group (P=0.02). Indexed late gadolinium enhancement significantly decreased in G-CSF group only (P=0.04). Moreover, over time improvement of global longitudinal strain was 2.4% higher in G-CSF patients versus SOC (P=0.04). Global circumferential strain significantly improved in G-CSF group only (P=0.006).
CONCLUSIONS


Early administration of G-CSF exerted a beneficial effect on top of SOC in patients with LV dysfunction after extensive ST-segment-elevation myocardial infarction in terms of global systolic function, adverse remodeling, scar size, and myocardial strain.
CLINICAL TRIAL REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT01969890.",2019,"Early administration of G-CSF exerted a beneficial effect on top of SOC in patients with LV dysfunction after extensive STEMI in terms of global systolic function, adverse remodeling, scar size, and myocardial strain.
","['Extensive STEMI', 'patients with anterior STEMI and left ventricular (LV) dysfunction after successful percutaneous coronary intervention (PCI', '161 STEMI patients were enrolled in the CMR Substudy and assigned to']","['standard of care (SOC) plus G-CSF or SOC alone', 'G-CSF', 'granulocyte colony stimulating factor (G-CSF']","['global longitudinal strain', 'infarct size and longer symptom-to-balloon time', 'indexed LV end-systolic volume', 'global systolic function, adverse remodeling, scar size, and myocardial strain', 'LVEF', 'CMR', 'Indexed LGE', 'Global circumferential strain']","[{'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0242698', 'cui_str': 'Ventricular Dysfunction, Left'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C1868749', 'cui_str': 'Myocardial strain'}, {'cui': 'C0205113', 'cui_str': 'Circumferential (qualifier value)'}]",161.0,0.0767638,"Early administration of G-CSF exerted a beneficial effect on top of SOC in patients with LV dysfunction after extensive STEMI in terms of global systolic function, adverse remodeling, scar size, and myocardial strain.
","[{'ForeName': 'Felice', 'Initials': 'F', 'LastName': 'Achilli', 'Affiliation': 'From the Departments of Cardiology (F.A., S.R., C.M., F.S.), ASST-Monza, San Gerardo Hospital, Monza, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Pontone', 'Affiliation': 'Cardiovascular Imaging (G. Pontone, M.G., G.M., A.B.), Centro Cardiologico Monzino IRCCS, Milano, Italy.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Bassetti', 'Affiliation': 'Vascular Biology and Regenerative Medicine Unit (B.B., G. Pompilio), Centro Cardiologico Monzino IRCCS, Milano, Italy.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Squadroni', 'Affiliation': 'Department of Cardiology, San Carlo Borromeo Hospital, Milano, Italy (L.S.).'}, {'ForeName': 'Jeness', 'Initials': 'J', 'LastName': 'Campodonico', 'Affiliation': 'Intensive Cardiac Care Unit (J.C.), Centro Cardiologico Monzino IRCCS, Milano, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Corrada', 'Affiliation': 'Cardiovascular Department, Humanitas Clinical and Research Center IRCCS, Rozzano, Italy (E.C.).'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Facchini', 'Affiliation': 'Cardiology, Bassini Hospital, Cinisello Balsamo, Italy (C.F.).'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Mircoli', 'Affiliation': ""Cardiology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy (L.M.).""}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Esposito', 'Affiliation': 'Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples Federico II, Napoli, Italy (G.E.).'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Scarpa', 'Affiliation': 'Cardiology, Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, Italy (D.S.).'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Pidello', 'Affiliation': 'Cardiology, Città della Salute e della Scienza University Hospital of Torino, Italy (S.P.).'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Righetti', 'Affiliation': 'From the Departments of Cardiology (F.A., S.R., C.M., F.S.), ASST-Monza, San Gerardo Hospital, Monza, Italy.'}, {'ForeName': 'Filiberto', 'Initials': 'F', 'LastName': 'Di Gennaro', 'Affiliation': 'Radiology (F.D.G.), ASST-Monza, San Gerardo Hospital, Monza, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Guglielmo', 'Affiliation': 'Cardiovascular Imaging (G. Pontone, M.G., G.M., A.B.), Centro Cardiologico Monzino IRCCS, Milano, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Muscogiuri', 'Affiliation': 'Cardiovascular Imaging (G. Pontone, M.G., G.M., A.B.), Centro Cardiologico Monzino IRCCS, Milano, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Baggiano', 'Affiliation': 'Cardiovascular Imaging (G. Pontone, M.G., G.M., A.B.), Centro Cardiologico Monzino IRCCS, Milano, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Limido', 'Affiliation': 'Coronary Intensive Care Unit, ASST-Settelaghi, Ospedale di Circolo-Fondazione Macchi, Varese, Italy (A.L.).'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lenatti', 'Affiliation': 'Cardiology, Alessandro Manzoni Hospital, Lecco, Italy (L.L.).'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Di Tano', 'Affiliation': 'Cardiology, ASST of Cremona, Italy (G.D.T.).'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Malafronte', 'Affiliation': 'From the Departments of Cardiology (F.A., S.R., C.M., F.S.), ASST-Monza, San Gerardo Hospital, Monza, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Soffici', 'Affiliation': 'From the Departments of Cardiology (F.A., S.R., C.M., F.S.), ASST-Monza, San Gerardo Hospital, Monza, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Ceseri', 'Affiliation': 'ANMCO Research Center, Heart Care Foundation, Firenze, Italy (M.C.).'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Maggiolini', 'Affiliation': 'Cardiology, San Leopoldo Mandic Hospital, Merate, Italy (S.M.).'}, {'ForeName': 'Gualtiero I', 'Initials': 'GI', 'LastName': 'Colombo', 'Affiliation': 'Immunology and Functional Genomics Unit (G.I.C.), Centro Cardiologico Monzino IRCCS, Milano, Italy.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Pompilio', 'Affiliation': 'Vascular Biology and Regenerative Medicine Unit (B.B., G. Pompilio), Centro Cardiologico Monzino IRCCS, Milano, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation research,['10.1161/CIRCRESAHA.118.314617']
282,32162970,Reduction in All-Cause Mortality with Fluticasone Furoate/Umeclidinium/Vilanterol in Patients with Chronic Obstructive Pulmonary Disease.,"Rationale:  The IMPACT (Informing the Pathway of Chronic Obstructive Pulmonary Disease Treatment) trial demonstrated a significant reduction in all-cause mortality (ACM) risk with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus UMEC/VI in patients with chronic obstructive pulmonary disease (COPD) at risk of future exacerbations. Five hundred seventy-four patients were censored in the original analysis owing to incomplete vital status information. Objectives:  Report ACM and impact of stepping down therapy, following collection of additional vital status data. Methods:  Patients were randomized 2:2:1 to FF/UMEC/VI 100/62.5/25 μg, FF/VI 100/25 μg, or UMEC/VI 62.5/25 μg following a run-in on their COPD therapies. Time to ACM was prespecified. Additional vital status data collection and subsequent analyses were performed  post hoc . Measurements and Main Results:  We report vital status data for 99.6% of the intention-to-treat population ( n  = 10,355), documenting 98 (2.36%) deaths on FF/UMEC/VI, 109 (2.64%) on FF/VI, and 66 (3.19%) on UMEC/VI. For FF/UMEC/VI, the hazard ratio for death was 0.72 (95% confidence interval, 0.53-0.99;  P  = 0.042) versus UMEC/VI and 0.89 (95% confidence interval, 0.67-1.16;  P  = 0.387) versus FF/VI. Independent adjudication confirmed lower rates of cardiovascular and respiratory death and death associated with the patient's COPD. Conclusions:  In this secondary analysis of an efficacy outcome from the IMPACT trial, once-daily single-inhaler FF/UMEC/VI triple therapy reduced the risk of ACM versus UMEC/VI in patients with symptomatic COPD and a history of exacerbations.",2020,"For FF/UMEC/VI, the hazard ratio for death was 0.72","['patients with symptomatic COPD and a history of exacerbations', 'Patients', 'COPD Patients', 'patients with COPD at risk of future exacerbations']","['Fluticasone Furoate/Umeclidinium/Vilanterol', 'FF/UMEC/VI 100/62.5/25', 'fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus UMEC/VI']","['hazard ratio for death', 'rates of cardiovascular and respiratory death, and death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0016884', 'cui_str': 'Future'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.617718,"For FF/UMEC/VI, the hazard ratio for death was 0.72","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'Clinical Sciences.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Crim', 'Affiliation': 'Clinical Sciences, GlaxoSmithKline, Research Triangle Park, North Carolina.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Pulmonary and Critical Care Medicine, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Nicola C', 'Initials': 'NC', 'LastName': 'Day', 'Affiliation': 'Safety and Medical Governance and.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Dransfield', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, Lung Health Center, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'David M G', 'Initials': 'DMG', 'LastName': 'Halpin', 'Affiliation': 'University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'MeiLan K', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': 'University of Michigan, Pulmonary and Critical Care, Ann Arbor, Michigan.'}, {'ForeName': 'C Elaine', 'Initials': 'CE', 'LastName': 'Jones', 'Affiliation': 'Development, R&D, and.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Kilbride', 'Affiliation': 'Biostatistics, GlaxoSmithKline, Uxbridge, Middlesex, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lange', 'Affiliation': 'Section of Epidemiology, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lomas', 'Affiliation': 'UCL Respiratory, University College London, London, United Kingdom.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Lettis', 'Affiliation': 'Biostatistics, GlaxoSmithKline, Uxbridge, Middlesex, United Kingdom.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Manchester', 'Affiliation': 'Global Clinical Science and Delivery, GlaxoSmithKline, Collegeville, Pennsylvania.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Martin', 'Affiliation': 'Global Medical Affairs, GlaxoSmithKline, Brentford, Middlesex, United Kingdom.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Midwinter', 'Affiliation': 'Biostatistics, GlaxoSmithKline, Uxbridge, Middlesex, United Kingdom.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Morris', 'Affiliation': 'Clinical Sciences, GlaxoSmithKline, Research Triangle Park, North Carolina.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Pascoe', 'Affiliation': 'Clinical Sciences.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Centre for Respiratory Medicine and Allergy, Institute of Inflammation and Repair, Manchester Academic Health Science Centre, The University of Manchester, Manchester University NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wise', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland; and.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, New York.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201911-2207OC']
283,32297442,Acupuncture for Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Survivors: A Randomized Controlled Pilot Trial.,"BACKGROUND


Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most debilitating long-term side effects in breast cancer survivors. We conducted a randomized controlled pilot trial to assess the feasibility, safety, and effects of an acupuncture intervention on CIPN in this population.
PATIENTS AND METHODS


Women with stage I-III breast cancer with grade 1 or higher CIPN after taxane-containing adjuvant chemotherapy were randomized 1:1 to an immediate acupuncture (IA) arm or to a waitlist control group (CG). Participants in the IA arm received 18 sessions of acupuncture over 8 weeks, then received no additional acupuncture. Patients in the CG arm received usual care over 8 weeks, followed by nine sessions of acupuncture over 8 weeks. Measures including Patient Neurotoxicity Questionnaire (PNQ), Functional Assessment of Cancer Therapy-Neurotoxicity subscale (FACT-NTX), and Brief Pain Inventory-short form (BPI-SF) were collected at baseline and at 4, 8, and 16 weeks after enrollment.
RESULTS


Forty women (median age, 54) were enrolled (20 to IA and 20 to CG), with median time between completion of chemotherapy and enrollment of 14 months (range 1-92). At 8 weeks, participants in the IA arm experienced significant improvements in PNQ sensory score (-1.0 ± 0.9 vs. -0.3 ± 0.6; p = .01), FACT-NTX summary score (8.7 ± 8.9 vs. 1.2 ± 5.4; p = .002), and BPI-SF pain severity score (-1.1 ± 1.7 vs. 0.3 ± 1.5; p = .03), compared with those in the CG arm. No serious side effects were observed.
CONCLUSION


Women with CIPN after adjuvant taxane therapy for breast cancer experienced significant improvements in neuropathic symptoms from an 8-week acupuncture treatment regimen. Additional larger studies are needed to confirm these findings.
IMPLICATIONS FOR PRACTICE


Chemotherapy-induced peripheral neuropathy (CIPN) is a toxicity that often persists for months to years after the completion of adjuvant chemotherapy for early breast cancer. In a randomized pilot trial of 40 breast cancer survivors with CIPN, an 8-week acupuncture intervention (vs. usual care) led to a statistically and clinically significant improvement in subjective sensory symptoms including neuropathic pain and paresthesia. Given the lack of effective therapies and established safety profile of acupuncture, clinicians may consider acupuncture as a treatment option for mild to moderate CIPN in practice.",2020,"No serious side effects were observed.
","['Women with stage I-III breast cancer with grade 1 or higher CIPN after', 'breast cancer survivors', '40 breast cancer survivors with CIPN, an 8-week', 'Forty women (median age, 54) were enrolled (20 to IA and 20 to CG), with median time between completion of chemotherapy and enrollment of 14 months (range 1-92', 'Breast Cancer Survivors']","['Acupuncture', 'taxane-containing adjuvant chemotherapy', 'acupuncture', 'taxane therapy', 'immediate acupuncture (IA) arm or to a waitlist control group (CG', 'acupuncture intervention']","['neuropathic symptoms', 'serious side effects', 'FACT-NTX summary score', 'BPI-SF pain severity score', 'PNQ sensory score', 'subjective sensory symptoms including neuropathic pain and paresthesia', 'Patient Neurotoxicity Questionnaire (PNQ), Functional Assessment of Cancer Therapy-Neurotoxicity subscale (FACT-NTX), and Brief Pain Inventory-short form (BPI-SF']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxicity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0423551', 'cui_str': 'Sensory symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}]",40.0,0.156072,"No serious side effects were observed.
","[{'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Giobbie-Hurder', 'Affiliation': 'Division of Biostatistics, Department of Data Sciences, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Freedman', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'Im Hee', 'Initials': 'IH', 'LastName': 'Shin', 'Affiliation': 'Department of Medical Statistics and Informatics, School of Medicine at the Catholic University of Daegu, Daegu, Republic of Korea.'}, {'ForeName': 'Nancy U', 'Initials': 'NU', 'LastName': 'Lin', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'Ann H', 'Initials': 'AH', 'LastName': 'Partridge', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Rosenthal', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Ligibel', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.'}]",The oncologist,['10.1634/theoncologist.2019-0489']
284,32192539,Protocol for a randomized controlled trial: peer-to-peer Group Problem Management Plus (PM+) for adult Syrian refugees in Turkey.,"BACKGROUND


A large proportion of Syrians have been exposed to potentially traumatic events, multiple losses, and breakdown of supportive social networks and many of them have sought refuge in host countries where they also face post-migration living difficulties such as discrimination or integration problems or both. These adversities may put Syrian refugees at high risk for common mental disorders. In response to this, the World Health Organization (WHO) developed a trans-diagnostic scalable psychological intervention called Problem Management Plus (PM+) to reduce psychological distress among populations exposed to adversities. PM+ has been adapted for Syrian refugees and can be delivered by non-specialist peer lay persons in the community.
METHODS


A randomized controlled trial (RCT) will be conducted with 380 Syrian refugees in Turkey. After providing informed consent, participants with high levels of psychological distress (scoring above 15 on the Kessler-10 Psychological Distress Scale (K10)) and functional impairment (scoring above 16 on the WHO Disability Assessment Schedule 2.0, or WHODAS 2.0) will be randomly assigned to Group PM+/enhanced care as usual (Group PM+/E-CAU) (n = 190) or E-CAU (n = 190). Outcome assessments will take place 1 week after the fifth session (post-assessment), 3 months after the fifth session and 12 months after baseline assessment. The primary outcome is psychological distress as measured by the Hopkins Symptom Checklist (HSCL-25). Secondary outcomes include functional impairment, post-traumatic stress symptoms, self-identified problems, and health system and productivity costs. A process evaluation will be conducted to explore the feasibility, challenges and success of the intervention with 25 participants, including participants, facilitators, policy makers and mental health professionals.
DISCUSSION


The treatment manual of the Syrian-Arabic Group PM+ and training materials will be made available through the WHO once the effectiveness and cost-effectiveness of Group PM+ have been established.
TRIAL REGISTRATION


Clinical Trial Registration: ClinicalTrials.gov Identifier NCT03960892. Unique protocol ID: 10/2017. Prospectively registered on 21 May 2019.",2020,"PM+ has been adapted for Syrian refugees and can be delivered by non-specialist peer lay persons in the community.
","['participants with high levels of psychological distress (scoring above\u200915 on the', 'adult Syrian refugees in Turkey', '380 Syrian refugees in Turkey', '25 participants, including participants, facilitators, policy makers and mental health professionals']","['peer-to-peer Group Problem Management Plus (PM', 'PM']","['Kessler-10 Psychological Distress Scale (K10)) and functional impairment', 'psychological distress as measured by the Hopkins Symptom Checklist (HSCL-25', 'functional impairment, post-traumatic stress symptoms, self-identified problems, and health system and productivity costs', 'psychological distress']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337819', 'cui_str': 'Syrians (ethnic group)'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}, {'cui': 'C0041400', 'cui_str': 'Turkey'}, {'cui': 'C4319693', 'cui_str': 'Three hundred and eighty'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0242170', 'cui_str': 'Policy Makers'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0030767', 'cui_str': 'Peer Group'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0222045'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist (assessment scale)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress (finding)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0683510', 'cui_str': 'Identifying problems (procedure)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.139306,"PM+ has been adapted for Syrian refugees and can be delivered by non-specialist peer lay persons in the community.
","[{'ForeName': 'Ersin', 'Initials': 'E', 'LastName': 'Uygun', 'Affiliation': 'Trauma Research Laboratory, Department of Psychology, Istanbul Sehir University, Istanbul, Turkey. ersinuygun@hotmail.com.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Ilkkursun', 'Affiliation': 'Psychology Department, Koc University, Istanbul, Turkey.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Sijbrandij', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'A Tamer', 'Initials': 'AT', 'LastName': 'Aker', 'Affiliation': 'Department of Psychiatry, Bilgi University, Istanbul, Turkey.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bryant', 'Affiliation': 'School of Psychology, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Cuijpers', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Daniela C', 'Initials': 'DC', 'LastName': 'Fuhr', 'Affiliation': 'Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'de Graaff', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Joop', 'Initials': 'J', 'LastName': 'de Jong', 'Affiliation': 'Faculty of Social and Behavioural Sciences, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'McDaid', 'Affiliation': 'Care Policy and Evaluation Centre, Department of Health Policy, London School of Economics and Political Science, London, UK.'}, {'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Morina', 'Affiliation': 'University Hospital Zurich, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'A-La', 'Initials': 'AL', 'LastName': 'Park', 'Affiliation': 'Care Policy and Evaluation Centre, Department of Health Policy, London School of Economics and Political Science, London, UK.'}, {'ForeName': 'Bayard', 'Initials': 'B', 'LastName': 'Roberts', 'Affiliation': 'Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ventevogel', 'Affiliation': 'Public Health Section, United Nations High Commissioner for Refugees, Geneva, Switzerland.'}, {'ForeName': 'Taylan', 'Initials': 'T', 'LastName': 'Yurtbakan', 'Affiliation': 'Trauma Research Laboratory, Department of Psychology, Istanbul Sehir University, Istanbul, Turkey.'}, {'ForeName': 'Ceren', 'Initials': 'C', 'LastName': 'Acarturk', 'Affiliation': 'Psychology Department, Koc University, Istanbul, Turkey.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-4166-x']
285,31605793,A Randomized Double-Blind Phase II Study of the Seneca Valley Virus (NTX-010) versus Placebo for Patients with Extensive-Stage SCLC (ES SCLC) Who Were Stable or Responding after at Least Four Cycles of Platinum-Based Chemotherapy: North Central Cancer Treatment Group (Alliance) N0923 Study.,"INTRODUCTION


The Seneca Valley virus (NTX-010) is an oncolytic picornavirus with tropism for SCLC. This phase II double-blind, placebo-controlled trial evaluated NTX-010 in patients with extensive-stage (ES) SCLC after completion of first-line chemotherapy.
METHODS


Patients with ES SCLC who did not progress after four or more cycles of platinum-based chemotherapy were randomized 1:1 to a single dose of NTX-010 or placebo within 12 weeks of chemotherapy. The primary end point was progression-free survival (PFS). A prespecified interim analysis for futility was performed after 40 events. Viral clearance and the development of neutralizing antibodies were followed.
RESULTS


From January 15, 2010, to January 10, 2013, a total of 50 patients were randomized and received therapy on study (26 received NTX-010 and 24 received placebo). At the specified interim analysis, the median PFS was 1.7 months (95% confidence interval [CI]: 1.4-3.1 months) for the NTX-010 group versus 1.7 months (95% CI: 1.4-4.3 months) for the placebo group (hazard ratio = 1.03, p = 0.92), and the trial was terminated owing to futility. In the NTX-010 group, PFS was shorter in patients with detectable virus at days 7 and 14 versus in those in whom it was not detected after treatment (1.0 month [95% CI: 0.4-1.5 months] versus 1.8 months [95% CI: 1.3-5.5 months, p = 0.008] and 0.9 months [95% CI: 0.4-2.6 months] versus 1.3 months [95% CI: 1.0-5.3 months], respectively [p = 0.04]).
CONCLUSIONS


Patients with ES SCLC did not benefit from NTX-010 treatment after chemotherapy with a platinum doublet. Persistence of NTX-010 in the blood 1 or 2 weeks after treatment was associated with a shorter PFS.",2020,"In the NTX-010 group, PFS was shorter in patients with detectable virus at days 7 and 14 versus not detected after treatment (1.0 month (95% CI 0.4-1.5 months) vs 1.8 months (95% CI 1.3-5.5 months; p=0.008); and 0.9 months (95% CI 0.4-2.6 months) vs 1.3 months (95% CI 1.0-5.3 months), p=0.04) respectively.
","['patients with extensive stage (ES) SCLC after completion of first line chemotherapy', 'patients with extensive stage SCLC (ES-SCLC) who were stable or responding after at least 4 cycles of platinum-based chemotherapy: NCCTG (Alliance) N0923 Study', 'ES-SCLC patients who did not progress after ≥4 cycles of platinum-based chemotherapy', 'From January 15, 2010 to January 10, 2013, 50 patients']","['Seneca Valley Virus (NTX-010) vs placebo', 'placebo', 'NTX-010', 'NTX-010 or placebo']","['progression free survival (PFS', 'median PFS', 'Viral clearance and the development of neutralizing antibodies', 'PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C1831871', 'cui_str': 'Senecavirus A'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}]",50.0,0.392168,"In the NTX-010 group, PFS was shorter in patients with detectable virus at days 7 and 14 versus not detected after treatment (1.0 month (95% CI 0.4-1.5 months) vs 1.8 months (95% CI 1.3-5.5 months; p=0.008); and 0.9 months (95% CI 0.4-2.6 months) vs 1.3 months (95% CI 1.0-5.3 months), p=0.04) respectively.
","[{'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Schenk', 'Affiliation': 'University of Colorado, Aurora, Colorado.'}, {'ForeName': 'Sumithra J', 'Initials': 'SJ', 'LastName': 'Mandrekar', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota; Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Grace K', 'Initials': 'GK', 'LastName': 'Dy', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}, {'ForeName': 'Marie Christine', 'Initials': 'MC', 'LastName': 'Aubry', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Angelina D', 'Initials': 'AD', 'LastName': 'Tan', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota; Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Shaker R', 'Initials': 'SR', 'LastName': 'Dakhil', 'Affiliation': 'Cancer Center of Kansas, Newton, Kansas.'}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Sachs', 'Affiliation': 'The Toledo Clinic-Maumee, Maumee, Ohio.'}, {'ForeName': 'Jorge J', 'Initials': 'JJ', 'LastName': 'Nieva', 'Affiliation': 'University of Southern California, Los Angeles, California.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Bertino', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lee Hann', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Schild', 'Affiliation': 'Mayo Clinic, Scottsdale, Arizona.'}, {'ForeName': 'Troy W', 'Initials': 'TW', 'LastName': 'Wadsworth', 'Affiliation': 'Northwest NCORP, Multicare Regional Cancer Center, Tacoma, Washington.'}, {'ForeName': 'Alex A', 'Initials': 'AA', 'LastName': 'Adjei', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Julian R', 'Initials': 'JR', 'LastName': 'Molina', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota. Electronic address: molina.julian@mayo.edu.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2019.09.083']
286,31538372,Differential Posttreatment Outcomes of Methylphenidate for Smoking Cessation for Individuals With ADHD.,"BACKGROUND AND OBJECTIVES


In a multisite, randomized study (CTN-0029), a 3-month course of Osmotic-Release Oral System Methylphenidate (OROS-MPH) improved smoking cessation in a group of patients with higher baseline severity in Attention-Deficit/Hyperactivity Disorder (ADHD). This treatment, however, worsened smoking cessation outcome in the group with lower baseline ADHD severity. We want to examine whether this differential treatment effect persisted after OROS-MPH was discontinued.
METHODS


We conducted a secondary analysis of the 1-month follow-up data from CTN-0029 after the discontinuation of OROS-MPH (N = 134). Nicotine patch was tapered during this month. We tested whether OROS-MPH had an effect on self-reported 7-day abstinence by week, as well as possible treatment by baseline ADHD severity interactions.
RESULTS


Abstinence diminished overall in time after the end of the treatment. In the high baseline severity group, patients who received OROS-MPH had an advantage in 7-day abstinence at week 15 (40% for OROS-MPH vs 20% for placebo, odds ratio = 2.63, P = .028). In the lower severity group (n = 121), no difference was detected (29% for OROS-MPH vs 32% for placebo, P = 1.00) between the two treatment groups. There was also a significant treatment by baseline ADHD severity interaction (P = .03).
CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE


OROS-MPH promotes abstinence beyond the course of treatment for patients with more severe ADHD, while the paradoxical effects in the lower baseline severity group is not persistent after medication discontinuation. Targeting ADHD in smoking cessation as a comorbidity therefore can have broader impact with more precise patient selection. (Am J Addict).",2019,"In the lower severity group (n = 121), no difference was detected (29% for OROS-MPH vs 32% for placebo, P = 1.00) between the two treatment groups.","['patients with more severe ADHD', 'patients with higher baseline severity in Attention-Deficit/Hyperactivity Disorder (ADHD', 'Individuals With ADHD']","['OROS-MPH', 'Osmotic-Release Oral System Methylphenidate (OROS-MPH', 'Nicotine patch', 'Methylphenidate']","['7-day abstinence', 'baseline ADHD severity interaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]",,0.240385,"In the lower severity group (n = 121), no difference was detected (29% for OROS-MPH vs 32% for placebo, P = 1.00) between the two treatment groups.","[{'ForeName': 'Sean X', 'Initials': 'SX', 'LastName': 'Luo', 'Affiliation': 'Department of Psychiatry, Division on Substance Use Disorders, Columbia University, New York, New York.'}, {'ForeName': 'Lirio S', 'Initials': 'LS', 'LastName': 'Covey', 'Affiliation': 'Department of Psychiatry, Division on Substance Use Disorders, Columbia University, New York, New York.'}, {'ForeName': 'Mei-Chen', 'Initials': 'MC', 'LastName': 'Hu', 'Affiliation': 'Department of Psychiatry, Division on Substance Use Disorders, Columbia University, New York, New York.'}, {'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Winhusen', 'Affiliation': 'Division of Addiction Sciences, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'Department of Psychiatry, Division on Substance Use Disorders, Columbia University, New York, New York.'}]",The American journal on addictions,['10.1111/ajad.12961']
287,32316070,"Efficacy and safety of ixekizumab in a phase III, randomized, double-blind, placebo-controlled study in paediatric patients with moderate-to-severe plaque psoriasis (IXORA-PEDS).","BACKGROUND


Plaque psoriasis affects children and adults, but treatment options for paediatric psoriasis are limited.
OBJECTIVES


To evaluate the efficacy and safety of ixekizumab (IXE), a high-affinity monoclonal antibody that selectively targets interleukin-17A, for moderate-to-severe paediatric psoriasis.
METHODS


In a randomized, double-blind, placebo-controlled, phase III study (IXORA-PEDS), patients aged 6 to < 18 years with moderate-to-severe plaque psoriasis were randomized 2 : 1 to weight-based dosing of IXE every 4 weeks (IXE Q4W, n = 115) or placebo (n = 56) through week 12, followed by open-label IXE Q4W. Coprimary endpoints were the proportions of patients at week 12 achieving ≥ 75% improvement in Psoriasis Area and Severity Index (PASI 75) and those achieving a static Physician's Global Assessment score of 0 or 1 (sPGA 0,1).
RESULTS


IXE was superior (P < 0·001) to placebo for both coprimary endpoints of PASI 75 (IXE Q4W, 89%; placebo, 25%) and sPGA (0,1) (IXE Q4W, 81%; placebo, 11%). IXE was also superior for all gated secondary endpoints, including PASI 75 and sPGA (0,1) at week 4, improvement in itch, and complete skin clearance. IXE Q4W provided significant (P < 0·001) improvements vs. placebo in quality of life and clearance of scalp and genital psoriasis. Responses at week 12 were sustained or further improved through week 48. Through week 12, 45% (placebo) and 56% (IXE) of patients reported treatment-emergent adverse events. One serious adverse event was reported (IXE), one patient discontinued due to an adverse event (placebo) and no deaths were reported.
CONCLUSIONS


IXE was superior to placebo in the treatment of moderate-to-severe paediatric psoriasis, and the safety profile was generally consistent with that observed in adults. What is already known about this topic? Paediatric psoriasis affects approximately 1% of children and can negatively impact health-related quality of life. Treatment options for paediatric psoriasis are typically limited to off-label treatments and approved systemic biologics. Ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin-17A, is approved for moderate-to-severe plaque psoriasis in adults and was recently approved by the US Food and Drug Administration for moderate-to-severe paediatric psoriasis. What does this study add? Ixekizumab resulted in rapid and statistically significant improvements over placebo in skin involvement, itch and health-related quality of life, which persisted through 48 weeks of treatment in paediatric patients with moderate-to-severe plaque psoriasis. The safety profile of ixekizumab was generally consistent with that seen in adults. Ixekizumab may be an additional potential therapeutic option and an additional class of biologic therapy (interleukin-17A antagonist) for the treatment of moderate-to-severe paediatric psoriasis.",2020,IXE Q4W provided significant (p<0·001) improvements versus placebo in quality of life and clearance of scalp and genital psoriasis.,"['patients (age 6 to <18 years) with moderate-to-severe plaque psoriasis', 'Paediatric Patients with Moderate-to-Severe Plaque Psoriasis (IXORA-PEDS']","['IXE', 'IXE every four weeks (IXE Q4W, N=115) or placebo', 'placebo', 'ixekizumab (IXE', 'Ixekizumab', 'Placebo']","['quality of life and clearance of scalp and genital psoriasis', 'safety profile', 'Efficacy and Safety', 'PASI 75 and sPGA (0,1) at Week 4, improvement in itch, and complete skin clearance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]",,0.383156,IXE Q4W provided significant (p<0·001) improvements versus placebo in quality of life and clearance of scalp and genital psoriasis.,"[{'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Paller', 'Affiliation': 'Department of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'M M B', 'Initials': 'MMB', 'LastName': 'Seyger', 'Affiliation': 'Department of Dermatology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Alejandro Magariños', 'Affiliation': 'Psoriahue, Buenos Aires, Argentina.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bagel', 'Affiliation': 'Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pinter', 'Affiliation': 'Department of Dermatology, Venereology and Allergology, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cather', 'Affiliation': 'Mindful Dermatology and Modern Research Associates, Dallas, TX, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Keller', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rodriguez Capriles', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gontijo Lima', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Gallo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Little', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Edson-Heredia', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Papp', 'Affiliation': 'K Papp Clinical Research and Probity Medical Research, Waterloo, ON, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The British journal of dermatology,['10.1111/bjd.19147']
288,30556911,Systemic Tofacitinib Concentrations in Adult Patients With Atopic Dermatitis Treated With 2% Tofacitinib Ointment and Application to Pediatric Study Planning.,"Atopic dermatitis is a chronic eczematous, pruritic, inflammatory skin condition affecting children and adults. Tofacitinib is a Janus kinase inhibitor. The efficacy, safety, and pharmacokinetics of 2% tofacitinib ointment twice daily have been evaluated in a 4-week phase 2a multisite randomized, double-blind, vehicle-controlled, parallel-group study (NCT02001181) in adult patients with mild to moderate atopic dermatitis and 2% to 20% body surface area (BSA) involvement. Tofacitinib ointment demonstrated significantly greater efficacy versus vehicle for all efficacy end points and had an acceptable safety profile. Predose and postdose pharmacokinetic samples were collected in week 2 and week 4. The objective of this analysis was to assess if predicted mean tofacitinib concentrations with topical application at higher treated BSA across age groups would exceed relevant concentration thresholds based on oral doses of tofacitinib. In this analysis, the pharmacokinetic concentrations were characterized using a linear mixed-effects model. The model was used to predict concentrations for adults with higher (>20%) treatable BSA. Adult concentrations were used to extrapolate concentrations to a pediatric population (2 to 17 years) using allometric principles. The predicted systemic concentrations for 2% tofacitinib ointment in both adult and pediatric populations at treated BSA ≤50% for a mild to moderate atopic dermatitis population did not exceed those reported for the 10th percentile of observed oral tofacitinib 5-mg twice-daily doses in patients with moderate to severe plaque psoriasis. The methodology described will enable analysis and prediction of systemic concentrations for topical agents.",2019,Tofacitinib ointment demonstrated significantly greater efficacy versus vehicle for all efficacy end points and had an acceptable safety profile.,"['With Atopic Dermatitis', 'adults with higher (>20%) treatable BSA', 'adult patients with mild to moderate atopic dermatitis and 2% to 20% body surface area (BSA) involvement', 'Adult Patients']","['Tofacitinib', 'Tofacitinib ointment', 'Tofacitinib Ointment']","['pharmacokinetic concentrations', 'efficacy, safety, and pharmacokinetics', 'Systemic Tofacitinib Concentrations', 'Predose and postdose pharmacokinetic samples', 'systemic concentrations']","[{'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}]","[{'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0028912', 'cui_str': 'Salves'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]",,0.188634,Tofacitinib ointment demonstrated significantly greater efficacy versus vehicle for all efficacy end points and had an acceptable safety profile.,"[{'ForeName': 'Vivek S', 'Initials': 'VS', 'LastName': 'Purohit', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Ports', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Cunshan', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Riley', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1360']
289,32321301,Effects of diabetes duration and HgA1C level on corneal endothelial morphology.,"OBJECTIVE


The aim of this study is to investigate the effects of the HbA1c level and the duration of diabetes mellitus on the corneal endothelium morphology and to compare between healthy individuals and diabetes mellitus patients with non-proliferative diabetic retinopathy and proliferative diabetic retinopathy.
MATERIAL AND METHODS


Ninety patients who applied to the Health Sciences University Ulucanlar Eye Training and Research Hospital between January 2016 and January 2017 were included in this prospective randomized study. In the study, 45 diabetes mellitus patients and 45 healthy individuals were evaluated. The diabetes patients were compared in terms of HbA1c level, diabetes mellitus duration, corneal endothelial cell density, coefficient of variation, standard deviation, and hexagonality with healthy control group.
RESULTS


A statistically significant difference was found in the endothelial cell densitometer, coefficient of variation, and standard deviation measurements between the diabetes mellitus patients and the control (healthy) group. But, there was no statistically significant difference between 6A (hexagonality) and central corneal thickness measurements. There was a negative correlation between HbA1c levels and diabetes mellitus times and endothelial cell densitometer values in the patients with diabetes mellitus diagnosis and standard deviation values in the positive direction. There was a statistically significant difference between diabetes mellitus patients with the diagnosis of non-proliferative diabetic retinopathy and proliferative diabetic retinopathy in the endothelial cell densitometer and standard deviation values. But there was not any statistically significant difference between coefficient of variation, 6A, and central corneal thickness values.
CONCLUSION


The endothelial cell densitometer in diabetes mellitus patients with retinopathy is lower than that in healthy individuals. There is a negative correlation between retinopathy severity and corneal endothelial cell density. Diabetes affects negatively not only vascular tissues but also avascular cornea.",2020,There was a statistically significant difference between diabetes mellitus patients with the diagnosis of non-proliferative diabetic retinopathy and proliferative diabetic retinopathy in the endothelial cell densitometer and standard deviation values.,"['45 diabetes mellitus patients and 45 healthy individuals', 'Ninety patients who applied to the Health Sciences University Ulucanlar Eye Training and Research Hospital between January 2016 and January 2017', 'diabetes mellitus patients with retinopathy', 'healthy individuals and diabetes mellitus patients with non-proliferative diabetic retinopathy and proliferative diabetic retinopathy']",[],"['HbA1c levels and diabetes mellitus times and endothelial cell densitometer values', 'coefficient of variation, 6A, and central corneal thickness values', 'HbA1c level, diabetes mellitus duration, corneal endothelial cell density, coefficient of variation, standard deviation, and hexagonality', 'endothelial cell densitometer, coefficient of variation, and standard deviation measurements', 'endothelial cell densitometer', 'corneal endothelial morphology', '6A (hexagonality) and central corneal thickness measurements', 'retinopathy severity and corneal endothelial cell density']","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0035309', 'cui_str': 'Retinal disorder'}, {'cui': 'C0004606', 'cui_str': 'Nonproliferative diabetic retinopathy'}, {'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}]",[],"[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0035309', 'cui_str': 'Retinal disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",90.0,0.0163855,There was a statistically significant difference between diabetes mellitus patients with the diagnosis of non-proliferative diabetic retinopathy and proliferative diabetic retinopathy in the endothelial cell densitometer and standard deviation values.,"[{'ForeName': 'Salih', 'Initials': 'S', 'LastName': 'Çolak', 'Affiliation': 'Ministry of Health, Osmaniye Government Hospital, Osmaniye, Turkey.'}, {'ForeName': 'Burcu', 'Initials': 'B', 'LastName': 'Kazanci', 'Affiliation': 'Ministry of Health, Ulucanlar Eye Research and Education Hospital, Ankara, Turkey.'}, {'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Ozçelik Soba', 'Affiliation': 'Ministry of Health, Ulucanlar Eye Research and Education Hospital, Ankara, Turkey.'}, {'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Ozdamar Erol', 'Affiliation': 'Ministry of Health, Ulucanlar Eye Research and Education Hospital, Ankara, Turkey.'}, {'ForeName': 'Pelin', 'Initials': 'P', 'LastName': 'Yilmazbas', 'Affiliation': 'Ministry of Health, Ulucanlar Eye Research and Education Hospital, Ankara, Turkey.'}]",European journal of ophthalmology,['10.1177/1120672120914812']
290,32250836,"Effect of a brief progressive resistance training program in hospital porters on pain, work ability, and physical function.","BACKGROUND


Hospital porters are possibly exposed to the greatest mechanical loads within the hospital environment. However, the evidence about preventive strategies in this population is scarce.
OBJECTIVE


To investigate the effect of a workplace-based progressive resistance-training program on musculoskeletal pain among hospital porters.
METHOD


A total of 37 hospital porters (27 women, 10 men) participated. Participants allocated to the intervention group performed five brief resistance training sessions/week, for 9 weeks during working hours at the hospital. Intensity was progressively increased. Participants allocated to the control group maintained their usual physical activity. The primary outcome was pain assessed with the patient global impression of pain change scale. Secondary outcome measures were average pain intensity, work ability, use of analgesics, and physical function. Additionally, perceived general changes were evaluated at follow-up: wellness, satisfaction at work, desire to exercise, motivation to eat healthy, energy to be with family and friends, and socialization with colleagues.
RESULTS


For the primary outcome, the intervention group showed lower general pain (p < 0.0001) and greater wellbeing (p < 0.0001), work satisfaction (p = 0.0048), desire for practicing exercise (p = 0.0007), and energy (p = 0.0474) compared with the control group. Significant between-group interactions were found for work impairment due to diseases (d = -1.2), hips/thighs pain (d = 0.7), ankles/feet pain (d = 0.4), the Biering-Sorensen test (d = -0.6) and the push-ups test (d = -2.3) favoring the intervention group. All between-group differences were clinically important.
CONCLUSION


A progressive resistance training program performed at the workplace is feasible and effective in reducing musculoskeletal pain and improving work ability and physical function among hospital porters.",2020,"For the primary outcome, the intervention group showed lower general pain (p < 0.0001) and greater wellbeing (p < 0.0001), work satisfaction (p = 0.0048), desire for practicing exercise (p = 0.0007), and energy (p = 0.0474) compared with the control group.","['musculoskeletal pain among hospital porters', 'A total of 37 hospital porters (27 women, 10 men) participated']","['workplace-based progressive resistance-training program', 'progressive resistance training program', 'brief resistance training sessions', 'control group maintained their usual physical activity']","['work satisfaction', 'pain assessed with the patient global impression of pain change scale', 'musculoskeletal pain and improving work ability and physical function', 'satisfaction at work, desire to exercise, motivation to eat healthy, energy to be with family and friends, and socialization with colleagues', 'desire for practicing exercise', 'greater wellbeing', 'average pain intensity, work ability, use of analgesics, and physical function', 'ankles/feet pain', 'hips/thighs pain', 'Intensity', 'pain, work ability, and physical function', 'lower general pain']","[{'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0402674', 'cui_str': 'Hospital porter'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0037447', 'cui_str': 'Socialization'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0016512', 'cui_str': 'Foot pain'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",37.0,0.0521316,"For the primary outcome, the intervention group showed lower general pain (p < 0.0001) and greater wellbeing (p < 0.0001), work satisfaction (p = 0.0048), desire for practicing exercise (p = 0.0007), and energy (p = 0.0474) compared with the control group.","[{'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Escriche-Escuder', 'Affiliation': 'Exercise Intervention for Health Research Group (EXINH-RG), Department of Physiotherapy, University of Valencia, Spain; Department of Physiotherapy, University of Malaga, Malaga, Spain.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Calatayud', 'Affiliation': 'Exercise Intervention for Health Research Group (EXINH-RG), Department of Physiotherapy, University of Valencia, Spain; National Research Centre for the Working Environment, Copenhagen, Denmark. Electronic address: joaquin.calatayud@uv.es.'}, {'ForeName': 'Lars L', 'Initials': 'LL', 'LastName': 'Andersen', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark; Sport Sciences, Department of Health Science and Technology, Aalborg University, Denmark.'}, {'ForeName': 'Yasmín', 'Initials': 'Y', 'LastName': 'Ezzatvar', 'Affiliation': 'Exercise Intervention for Health Research Group (EXINH-RG), Department of Physiotherapy, University of Valencia, Spain.'}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Aiguadé', 'Affiliation': 'Department of Nursing and Physiotherapy, University of Lleida, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Casaña', 'Affiliation': 'Exercise Intervention for Health Research Group (EXINH-RG), Department of Physiotherapy, University of Valencia, Spain.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102162']
291,32315696,Testing the effects of transcranial direct current stimulation (tDCS) on the face inversion effect and the N170 event-related potentials (ERPs) component.,"The following study investigates the effects of tDCS on face recognition skills indexed by the face inversion effect (better recognition performance for upright vs. inverted faces). We combined tDCS and EEG simultaneously to examine the effects of tDCS on the face inversion effect behaviourally and on the N170 ERPs component. The results from two experiments (overall N = 112) show that anodal tDCS delivered at Fp3 site for 10 min at 1.5 mA (double-blind and between-subjects) can reduce behaviourally the face inversion effect compared to sham (control) stimulation. The ERP results provide some evidence for tDCS being able to influence the face inversion effect on the N170. Specifically, we find a dissociation of the tDCS-induced effects where for the N170 latencies the tDCS reduces the usual face inversion effect (delayed N170 in response to inverted vs. upright faces) compared to sham. Contrarily, the same tDCS procedure on the same participants increased the inversion effect seen in the N170 amplitudes by making the negative deflection for the inverted faces that much greater than that for upright faces. We interpret our results in the context of the literature on the face inversion effect and the N170 peak component. In doing so, we extend our results to previous studies investigating the effects of tDCS on perceptual learning and face recognition.",2020,The following study investigates the effects of tDCS on face recognition skills indexed by the face inversion effect (better recognition performance for upright vs. inverted faces).,[],"['tDCS', 'transcranial direct current stimulation (tDCS', 'anodal tDCS']",['perceptual learning and face recognition'],[],"[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}]",,0.0243991,The following study investigates the effects of tDCS on face recognition skills indexed by the face inversion effect (better recognition performance for upright vs. inverted faces).,"[{'ForeName': 'Ciro', 'Initials': 'C', 'LastName': 'Civile', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK. Electronic address: c.civile@exeter.ac.uk.'}, {'ForeName': 'Emika', 'Initials': 'E', 'LastName': 'Waguri', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Quaglia', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Wooster', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Curtis', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'Rossy', 'Initials': 'R', 'LastName': 'McLaren', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'Aureliu', 'Initials': 'A', 'LastName': 'Lavric', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'I P L', 'Initials': 'IPL', 'LastName': 'McLaren', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK. Electronic address: i.p.l.mclaren@exeter.ac.uk.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2020.107470']
292,32316007,Deep Brain Stimulation for Spasmodic Dysphonia: A Blinded Comparison of Unilateral and Bilateral Stimulation in Two Patients.,"Deep brain stimulation (DBS) is a promising new therapy for patients with spasmodic dysphonia (SD). The preliminary results from our randomized controlled trial showed good clinical effects with unilateral left thalamic stimulation in 6 right- handed patients. This suggests that the pathological process underpinning SD may have a ""hemisphere dominant"" pathway. We describe 2 patients with concurrent essential tremor and SD who had previously undergone bilateral thalamic DBS for their limb tremor. Both patients experienced an unanticipated improvement of their SD symptoms. One patient was right-handed, and the other was mixed left-handed. To investigate the amount of SD improvement following DBS therapy in each hemisphere, 4 different settings were tested: both sides on, left side on, right side on, and both sides off. Both patients most improved following bilateral stimulation. There was, however, a powerful unilateral benefit in both patients with only a small additional benefit from bilateral stimulation. The right-handed patient improved most with left-hemisphere stimulation whereas the mixed left-handed patient improved most with right hemisphere stimulation. There was some discrepancy between the two tests applied in the second patient reflecting the known difficulties to evaluate vocal symptom improvement in SD. We discuss the possible correlation of handedness and speech hemisphere dominance as well as the need for more reliable tests to measure SD severity. Ultimately, we recommend a bilateral approach for future studies, using a patient perception test as the primary outcome and functional imaging to further investigate the correlation of handedness and the amount of hemisphere dominance in SD.",2020,The right-handed patient improved most with left-hemisphere stimulation whereas the mixed left-handed patient improved most with right hemisphere stimulation.,"['Spasmodic Dysphonia', '6 right- handed patients', 'Two Patients', '2 patients with concurrent essential tremor and SD who had previously undergone bilateral thalamic DBS for their limb tremor', 'patients with spasmodic dysphonia (SD']",['Deep brain stimulation (DBS'],"['SD symptoms', 'vocal symptom improvement']","[{'cui': 'C0264588', 'cui_str': 'Spastic dysphonia'}, {'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0270736', 'cui_str': 'Essential tremor'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0235081', 'cui_str': 'Tremor, Limb'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}]","[{'cui': 'C0264588', 'cui_str': 'Spastic dysphonia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",2.0,0.0807081,The right-handed patient improved most with left-hemisphere stimulation whereas the mixed left-handed patient improved most with right hemisphere stimulation.,"[{'ForeName': 'Marie T', 'Initials': 'MT', 'LastName': 'Krüger', 'Affiliation': 'Division of Neurosurgery, University of British Columbia, Vancouver, British Columbia, Canada, marie.krueger@mac.com.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Hu', 'Affiliation': 'Division of Otolaryngology, Head and Neck Surgery, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Honey', 'Affiliation': 'Division of Neurosurgery, University of British Columbia, Vancouver, British Columbia, Canada.'}]",Stereotactic and functional neurosurgery,['10.1159/000507058']
293,30122068,Smoking cessation after nurse-coordinated referral to a comprehensive lifestyle programme in patients with coronary artery disease: a substudy of the RESPONSE-2 trial.,"OBJECTIVE


The objective of this study was to investigate the characteristics of successful quitters, their use of a smoking cessation programme and the use of other lifestyle interventions to improve lifestyle-related risk factors, within a nurse-coordinated care programme.
METHODS


We used data from the multicentre randomised controlled RESPONSE-2 trial ( n=824, The Netherlands). The trial was designed to assess the efficacy of nurse-coordinated referral to a comprehensive set of up to three community-based interventions, based on smoking cessation, healthy food choices and physical activity to improve lifestyle-related risk factors in coronary artery disease patients, compared to usual care. Smoking status was assessed using urinary cotinine at baseline and 12 months follow-up.
RESULTS


At 12 months follow-up, there was no statistically significant difference in cessation rates (50% intervention group vs. 46% usual care group, P=0.45). The majority of successful quitters in both groups quit immediately after hospitalisation (72% intervention group vs. 86% usual care group, P=0.29). Only 19% of successful quitters in the intervention group participated in the smoking cessation programme. However, successful quitters participated more frequently in other lifestyle programmes compared with persistent smokers (65% vs. 37%, P<0.01).
CONCLUSION


The majority of patients who successfully quit smoking are those who quit immediately after hospitalisation, without a need to participate in a smoking cessation programme. Moreover, this programme was attended by only a minority of successful quitters. Successful quitters were motivated to attend other lifestyle programmes addressing healthy food choices and physical activity. Our findings support a tailored, comprehensive approach to lifestyle interventions in the secondary prevention of coronary artery disease.",2019,"The majority of successful quitters in both groups quit immediately after hospitalisation (72% intervention group vs. 86% usual care group, P=0.29).","['coronary artery disease patients', 'patients with coronary artery disease']","['Smoking cessation after nurse-coordinated referral to a comprehensive lifestyle programme', 'smoking cessation programme']","['majority of successful quitters', 'cessation rates', 'Smoking status']","[{'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",824.0,0.0440029,"The majority of successful quitters in both groups quit immediately after hospitalisation (72% intervention group vs. 86% usual care group, P=0.29).","[{'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Snaterse', 'Affiliation': '1 ACHIEVE Centre of Applied Research, Amsterdam University of Applied Sciences, The Netherlands.'}, {'ForeName': 'Harald T', 'Initials': 'HT', 'LastName': 'Jorstad', 'Affiliation': '2 Department of Cardiology, Academic Medical Centre, The Netherlands.'}, {'ForeName': 'Madelon', 'Initials': 'M', 'LastName': 'Minneboo', 'Affiliation': '2 Department of Cardiology, Academic Medical Centre, The Netherlands.'}, {'ForeName': 'Sangeeta', 'Initials': 'S', 'LastName': 'Lachman', 'Affiliation': '2 Department of Cardiology, Academic Medical Centre, The Netherlands.'}, {'ForeName': 'S Matthijs', 'Initials': 'SM', 'LastName': 'Boekholdt', 'Affiliation': '2 Department of Cardiology, Academic Medical Centre, The Netherlands.'}, {'ForeName': 'Gerben', 'Initials': 'G', 'LastName': 'Ter Riet', 'Affiliation': '3 Department of General Practice, Academic Medical Centre, The Netherlands.'}, {'ForeName': 'Wilma Jm', 'Initials': 'WJ', 'LastName': 'Scholte Op Reimer', 'Affiliation': '1 ACHIEVE Centre of Applied Research, Amsterdam University of Applied Sciences, The Netherlands.'}, {'ForeName': 'Ron Jg', 'Initials': 'RJ', 'LastName': 'Peters', 'Affiliation': '2 Department of Cardiology, Academic Medical Centre, The Netherlands.'}]",European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology,['10.1177/1474515118795722']
294,30129790,MOVE-HF: an internet-based pilot study to improve adherence to exercise in patients with heart failure.,"AIM


The use of the internet and newer activity monitors such as the Fitbit Charge HR to improve exercise adherence is limited. The primary aim of the Move on Virtual Engagement (MOVE-HF) was to investigate the effects of group social support by internet-based synchronized face-to-face video and objective physical activity feedback on adherence to recommended exercise guidelines.
METHODS


Thirty stable heart failure patients (New York Heart Association class I-III), aged 64.7±11.5 years, were randomly assigned to an experimental or comparison group. Participants were provided a handout on self-care in heart failure, an exercise routine, a Fitbit Charge HR and were asked to wear the Fitbit Charge HR daily, and record their exercise sessions using both the Fitbit Charge HR and exercise diaries. In addition, participants in the experimental group connected to Vidyo software, once a week, for 8 weeks, for a 45-minute face-to-face online group discussion/education session.
RESULTS


Overall Vidyo session attendance was 68%, with 73% of participants attending five or more sessions. Adherence to exercise was 58.8% in the experimental group and 57.3% in the comparison group. The experimental group perceived receiving social support through the internet-based synchronized face-to-face video meetings but due to a small sample size and lack of adequate power, no significant impact on exercise adherence was observed. Participants commented that feedback regarding physical activity from the Fitbit Charge HR was helpful and motivational.
CONCLUSION


Delivering social support by internet-based synchronized face-to-face video is feasible with heart failure patients. However, more investigations are needed to understand its impact on exercise adherence.",2019,Adherence to exercise was 58.8% in the experimental group and 57.3% in the comparison group.,"['heart failure patients', 'Thirty stable heart failure patients (New York Heart Association class I-III), aged 64.7±11.5 years', 'patients with heart failure']","['MOVE-HF', 'Virtual Engagement (MOVE-HF', 'group social support by internet-based synchronized face-to-face video and objective physical activity feedback', 'receiving social support through the internet-based synchronized face-to-face video meetings', 'Delivering social support by internet-based synchronized face-to-face video']","['Overall Vidyo session attendance', 'Adherence to exercise', 'exercise adherence']","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441885', 'cui_str': 'Class 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0037438'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",30.0,0.0324775,Adherence to exercise was 58.8% in the experimental group and 57.3% in the comparison group.,"[{'ForeName': 'Pallav', 'Initials': 'P', 'LastName': 'Deka', 'Affiliation': '1 Department of Nursing, University of South Dakota, USA.'}, {'ForeName': 'Bunny', 'Initials': 'B', 'LastName': 'Pozehl', 'Affiliation': '2 College of Nursing, University of Nebraska Medical Center, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Williams', 'Affiliation': '3 Divison of Cardiology, Creighton University School of Medicine, USA.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Norman', 'Affiliation': '4 College of Allied Health Professions, University of Nebraska Medical Center, USA.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Khazanchi', 'Affiliation': '5 College of Information Science and Technology, University of Nebraska at Omaha, USA.'}, {'ForeName': 'Dola', 'Initials': 'D', 'LastName': 'Pathak', 'Affiliation': '6 Department of Statistics, University of Nebraska at Lincoln, USA.'}]",European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology,['10.1177/1474515118796613']
295,32320773,"Surgery versus combined treatment with curettage and imiquimod for nodular basal cell carcinoma: One-year results of a noninferiority, randomized, controlled trial.","PURPOSE


Nodular basal cell carcinoma (nBCC) is mostly treated with surgical excision. Interest in minimally invasive treatment of these low-risk tumors is increasing. We assessed the effectiveness of nBCC treatment with curettage and imiquimod cream compared with surgical excision.
METHODS


Patients with nBCC included in this randomized, controlled noninferiority trial were randomly assigned to either a curettage and imiquimod cream group or a surgical excision group. The primary endpoint was the proportion of patients free from treatment failure 1 year after the end of treatment. A prespecified noninferiority margin of 8% was used. A modified intention-to-treat and a per-protocol analysis was performed (ClinicalTrials.gov identifier NCT02242929).
RESULTS


One hundred forty-five patients were randomized: 73 to the curettage and imiquimod cream group and 72 to the surgical excision group. The proportion of patients free of recurrence after 12 months was 86.3% (63/73) for the curettage and imiquimod group and 100% (72/72) for the surgical excision group. The difference in efficacy was -13.7% (95% confidence interval -21.6% to -5.8%; 1-sided P = .0004) favoring surgical excision.
CONCLUSION


Noninferiority of curettage and imiquimod cream cannot be concluded. Given the still high efficacy of curettage and imiquimod cream and the indolent growth pattern of nBCC, curettage and imiquimod could still be a valuable treatment option with the possibility to prevent overuse of excisions. However, it cannot replace surgical excision.",2020,Proportion of patients free of recurrence after 12 months was 86.3% for curettage and imiquimod (63/73) and 100% for excision (72/72).,"['Nodular basal cell carcinoma (nBCC', '145 patients were randomized; 73 to', 'Patients with nodular BCC', 'Nodular basal cell carcinoma (SCIN']","['imiquimod cream', 'curettage and imiquimod cream and 72 to surgical excision', 'imiquimod', 'Surgery versus combined treatment with Curettage and Imiquimod', 'nBCC', 'curettage and imiquimod cream or surgical excision', 'curettage and imiquimod cream']","['efficacy', 'proportion of patients free from treatment failure one 1 year']","[{'cui': 'C1304300', 'cui_str': 'Nodular basal cell carcinoma of skin'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205297', 'cui_str': 'Nodular'}, {'cui': 'C4721806', 'cui_str': 'Basal cell carcinoma of skin'}]","[{'cui': 'C1252977', 'cui_str': 'imiquimod Topical Cream'}, {'cui': 'C0010468', 'cui_str': 'Curettage'}, {'cui': 'C0728940', 'cui_str': 'Excision'}, {'cui': 'C0165032', 'cui_str': 'imiquimod'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1304300', 'cui_str': 'Nodular basal cell carcinoma of skin'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0439234', 'cui_str': 'year'}]",145.0,0.0800048,Proportion of patients free of recurrence after 12 months was 86.3% for curettage and imiquimod (63/73) and 100% for excision (72/72).,"[{'ForeName': 'Kelly A E', 'Initials': 'KAE', 'LastName': 'Sinx', 'Affiliation': 'Department of Dermatology, Maastricht University Medical Center, Maastricht, The Netherlands; GROW Research Institute for Oncology and Developmental Biology, Maastricht University, Maastricht, The Netherlands. Electronic address: kelly.sinx@mumc.nl.'}, {'ForeName': 'Patty J', 'Initials': 'PJ', 'LastName': 'Nelemans', 'Affiliation': 'Department of Epidemiology, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Nicole W J', 'Initials': 'NWJ', 'LastName': 'Kelleners-Smeets', 'Affiliation': 'Department of Dermatology, Maastricht University Medical Center, Maastricht, The Netherlands; GROW Research Institute for Oncology and Developmental Biology, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Veronique J L', 'Initials': 'VJL', 'LastName': 'Winnepenninckx', 'Affiliation': 'Department of Pathology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Aimee H M M', 'Initials': 'AHMM', 'LastName': 'Arits', 'Affiliation': 'Department of Dermatology, Maastricht University Medical Center, Maastricht, The Netherlands; GROW Research Institute for Oncology and Developmental Biology, Maastricht University, Maastricht, The Netherlands; Department of Pathology, Maastricht University Medical Center, Maastricht, The Netherlands; Department of Dermatology, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Klara', 'Initials': 'K', 'LastName': 'Mosterd', 'Affiliation': 'Department of Dermatology, Maastricht University Medical Center, Maastricht, The Netherlands; GROW Research Institute for Oncology and Developmental Biology, Maastricht University, Maastricht, The Netherlands.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.04.053']
296,32319740,Sex-dependent least toxic timing of irinotecan combined with chronomodulated chemotherapy for metastatic colorectal cancer: Randomized multicenter EORTC 05011 trial.,"The least toxic time (LTT) of irinotecan varied by up to 8 hours according to sex and genetic background in mice. The translational relevance was investigated within a randomized trial dataset, where no LTT stood out significantly in the whole population. 130 male and 63 female eligible patients with metastatic colorectal cancer were randomized to receive chronomodulated Irinotecan with peak delivery rate at 1 of 6 clock hours staggered by 4 hours on day 1, then fixed-time chronomodulated Fluorouracil-Leucovorin-Oxaliplatin for 4 days, q3 weeks. The sex-specific circadian characteristics of grade (G) 3-4 toxicities were mapped with cosinor and time*sex interactions confirmed with Fisher's exact test. Baseline characteristics of male or female patients were similar in the six treatment groups. Main grade 3-4 toxicities over six courses were diarrhea (males vs females, 39.2%; vs 46.0%), neutropenia (15.6% vs 15.0%), fatigue (11.5% vs 15.9%), and anorexia (10.0% vs 7.8%). They were reduced following irinotecan peak delivery in the morning for males, but in the afternoon for females, with statistically significant rhythms (P < .05 from cosinor) and sex*timing interactions (Fisher's exact test, diarrhea, P = .023; neutropenia, P = .015; fatigue, P = .062; anorexia, P = .032). Irinotecan timing was most critical for females, with grades 3-4 ranging from 55.2% of the patients (morning) to 29.4% (afternoon) for diarrhea, and from 25.9% (morning) to 0% (afternoon) for neutropenia. The study results support irinotecan administration in the morning for males and in the afternoon for females, in order to minimize adverse events without impairing efficacy.",2020,"They were reduced following irinotecan peak delivery in the morning for males, but","['metastatic colorectal cancer', 'male or female patients', '130 male and 63 female eligible patients with metastatic colorectal cancer']","['irinotecan combined with chronomodulated chemotherapy', 'Fluorouracil-Leucovorin-Oxaliplatin', 'chronomodulated Irinotecan', 'Irinotecan', 'irinotecan']","['diarrhea', 'anorexia', 'fatigue', 'Main grade 3-4 toxicities', 'least toxic time (LTT', 'neutropenia']","[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319552', 'cui_str': '130'}]","[{'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}]",130.0,0.0775641,"They were reduced following irinotecan peak delivery in the morning for males, but","[{'ForeName': 'Pasquale F', 'Initials': 'PF', 'LastName': 'Innominato', 'Affiliation': 'North Wales Cancer Centre, Betsi Cadwaladr University Health Board, Bangor, United Kingdom.'}, {'ForeName': 'Annabelle', 'Initials': 'A', 'LastName': 'Ballesta', 'Affiliation': 'Division of Biomedical Sciences, Cancer Chronotherapy Team, Cancer Research Centre, Warwick Medical School, Coventry, United Kingdom.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Division of Biomedical Sciences, Cancer Chronotherapy Team, Cancer Research Centre, Warwick Medical School, Coventry, United Kingdom.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Focan', 'Affiliation': 'Department of Oncology, Clinique Saint-Joseph, CHC-Liège Hospital Group, Liège, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Chollet', 'Affiliation': 'Clinical and Translational Research Division, Jean Perrin Comprehensive Cancer Centre, Clermont-Ferrand, France.'}, {'ForeName': 'Abdoulaye', 'Initials': 'A', 'LastName': 'Karaboué', 'Affiliation': 'Medical Oncology Unit, GHI Le Raincy-Montfermeil, Montfermeil, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Giacchetti', 'Affiliation': 'UMRS 935, ""Cancer Chronotherapy and Postoperative Liver Functions"", French National Institute for Health and Medical Research (INSERM) and Paris-Sud University, Villejuif, France.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Bouchahda', 'Affiliation': 'UMRS 935, ""Cancer Chronotherapy and Postoperative Liver Functions"", French National Institute for Health and Medical Research (INSERM) and Paris-Sud University, Villejuif, France.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Adam', 'Affiliation': 'UMRS 935, ""Cancer Chronotherapy and Postoperative Liver Functions"", French National Institute for Health and Medical Research (INSERM) and Paris-Sud University, Villejuif, France.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Garufi', 'Affiliation': 'Division of Medical Oncology, San Camillo Forlanini Hospital, Roma, Italy.'}, {'ForeName': 'Francis A', 'Initials': 'FA', 'LastName': 'Lévi', 'Affiliation': 'Division of Biomedical Sciences, Cancer Chronotherapy Team, Cancer Research Centre, Warwick Medical School, Coventry, United Kingdom.'}]",Cancer medicine,['10.1002/cam4.3056']
297,32179132,Outcomes for Hyperthermia Combined with Concurrent Radiochemotherapy for Patients with Cervical Cancer.,"PURPOSE


To evaluate the effect of hyperthermia combined with concurrent radiochemotherapy (RCT) and treatment-related toxicity in patients with cervical cancer (CC) stage IB-IV.
METHODS AND MATERIALS


This study was conducted between 2009 and 2013 in patients with International Federation of Gynecology and Obstetrics (FIGO) stage IB-IV CC. The patients were randomly assigned into 2 treatment groups: RCT and RCT plus hyperthermia (RCHT). Five-year survival, treatment-related toxicity, and other prognostic factors were evaluated.
RESULTS


Three hundred seventy-three patients completed treatment and were analyzed by per-protocol (PP) analysis. The 5-year overall survival (OS) in the RCHT group (81.9%) was better than that in RCT group (72.3%), and the log-rank test showed a statistically significant difference between the 2 groups (P = .040). Univariate and multivariate Cox regression analysis for 5-year OS showed a statistically significant difference (P = .043, P = .045, respectively). The 5-year local relapse-free survival in RCHT (86.8%) was also better than that in RCT (82.7%), but the difference was not significant. Acute or late toxicity was not significantly different between the 2 groups. Advanced clinical stage (FIGO) and larger tumor size showed higher risk of death and a relatively poor prognosis in univariate and multivariate analysis.
CONCLUSIONS


The study confirmed that hyperthermia combined with RCT yielded a better 5-year OS in CC. Acute and late toxicity was similar between the RCT and RCHT groups. Clinical stage (FIGO) and tumor size were independent prognostic factors in CC.",2020,The 5-year overall survival (OS) in RCHT group (81.9%) was better than that in RCT group (72.3%) and the log-rank test showed statistically significant difference between the two groups (p=0.040).,"['373 patients completed treatment and were analyzed by per protocol (PP) analysis', '2009 and 2013 in CC patients with the International Federation of Gynecology and Obstetrics (FIGO) stage IB-IV', 'patients with cervical cancer (CC) stage IB-IV', 'patients with cervical cancer']","['RCT', 'RCT and RCT plus hyperthermia (RCHT', 'hyperthermia combined with concurrent radiochemotherapy', 'HT combined to RCT', 'hyperthermia (HT) combined with concurrent radiochemotherapy (RCT']","['5-year survival', '5-year OS', '5-year overall survival (OS', 'Acute or late toxicity', 'Clinical stage (FIGO) and tumor size', '5-year local relapse-free survival (LRFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0450454', 'cui_str': 'FIGO Stage'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0457152', 'cui_str': 'Stage Ib'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205563', 'cui_str': 'Clinical staging (qualifier value)'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",,0.250432,The 5-year overall survival (OS) in RCHT group (81.9%) was better than that in RCT group (72.3%) and the log-rank test showed statistically significant difference between the two groups (p=0.040).,"[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Hong', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Shaomin', 'Initials': 'S', 'LastName': 'Che', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Yingbing', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Du', 'Initials': 'D', 'LastName': 'Meng', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Shi', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Su', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Yunyi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Hailin', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Jiquan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Beina', 'Initials': 'B', 'LastName': 'Hui', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Jinli', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Zi', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. Electronic address: chenhwdr@hotmail.com.""}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.03.006']
298,32087031,Oral provocation of patients allergic to sesquiterpene lactones with German chamomile tea to demonstrate possible systemic allergic dermatitis.,"BACKGROUND


Most patients with contact allergy to Asteraceae plants are patch test positive to sesquiterpene lactone mix (SLM). There are several reports among these patients of a flare-up of hand eczema after ingestion of food and beverages originating from Asteraceae plants.
AIM


To investigate whether German chamomile tea can elicit systemic allergic dermatitis.
PATIENTS AND METHODS


Individuals with or without contact allergy to SLM were patch tested with an extract of German chamomile tea. Six weeks later, they were provoked with capsules containing either freeze-dried German chamomile tea or placebo capsules containing lactose, in a double-blind, randomized study. A numerical rating scale (NRS) was used to ascertain the volunteers' opinion of their hand eczema status. The study individuals were examined to detect a possible flare-up of healed patch test reactions to chamomile.
RESULTS


None of the subjects had a flare-up of healed patch test reactions. According to the NRS, SLM-positive individuals experienced a significant worsening of hand eczema, independently of whether they received chamomile or lactose capsules.
CONCLUSION


No evidence suggestive of systemic allergic dermatitis was found.",2020,"The study individuals were examined to detect a possible flare-up of healed patch test reactions to chamomile.
","['patients with contact allergy to Asteraceae plants', 'Individuals with or without contact allergy to SLM were patch tested with an extract of German chamomile tea', 'patients allergic to sesquiterpene lactones with']","['German chamomile tea', 'freeze-dried German chamomile tea or placebo capsules containing lactose', 'sesquiterpene lactone mix (SLM']",['systemic allergic contact dermatitis'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002111', 'cui_str': 'Allergy Specialty'}, {'cui': 'C0446228', 'cui_str': 'Compositae'}, {'cui': 'C0032098', 'cui_str': 'Plants'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030646', 'cui_str': 'Patch Tests'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C1510478', 'cui_str': 'Matricaria chamomilla'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0036847', 'cui_str': 'Sesquiterpenes'}, {'cui': 'C0022947', 'cui_str': 'Lactones'}]","[{'cui': 'C1510478', 'cui_str': 'Matricaria chamomilla'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0016698', 'cui_str': 'Lyophilization'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0022949', 'cui_str': 'Lactose'}, {'cui': 'C0439985', 'cui_str': 'Sesquiterpene lactone mix (product)'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0162820', 'cui_str': 'Dermatitis, Allergic Eczematous'}]",,0.150894,"The study individuals were examined to detect a possible flare-up of healed patch test reactions to chamomile.
","[{'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Lundh', 'Affiliation': 'Department of Occupational and Environmental Dermatology, Lund University, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Gruvberger', 'Affiliation': 'Department of Occupational and Environmental Dermatology, Lund University, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Persson', 'Affiliation': 'Department of Occupational and Environmental Dermatology, Lund University, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Hindsén', 'Affiliation': 'Department of Occupational and Environmental Dermatology, Lund University, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Zimerson', 'Affiliation': 'Department of Occupational and Environmental Dermatology, Lund University, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Åke', 'Initials': 'Å', 'LastName': 'Svensson', 'Affiliation': 'Department of Dermatology, Lund University, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Bruze', 'Affiliation': 'Department of Occupational and Environmental Dermatology, Lund University, Skåne University Hospital, Malmö, Sweden.'}]",Contact dermatitis,['10.1111/cod.13499']
299,31271885,Effect of Sirolimus on Immune Reconstitution Following Myeloablative Allogeneic Stem Cell Transplantation: An Ancillary Analysis of a Randomized Controlled Trial Comparing Tacrolimus/Sirolimus and Tacrolimus/Methotrexate (Blood and Marrow Transplant Clinical Trials Network/BMT CTN 0402).,"Although allogeneic hematopoietic cell transplantation (HCT) is a potentially curative therapy for hematologic neoplasms, one of its limiting toxicities continues to be graft-versus-host disease, both acute (aGVHD) and chronic (cGVHD). Sirolimus is a mammalian target of rapamycin inhibitor that has proven effective in GVHD prophylaxis in combination with a calcineurin inhibitor, such as tacrolimus. The impact of sirolimus on immune reconstitution has not been comprehensively investigated in vivo thus far, however. Here we present an ancillary analysis of the randomized study BMT-CTN 0402 that examined the effect of sirolimus on immune subsets post-transplantation. We further examine the association between different lymphocyte subsets and outcomes post-transplantation in each arm. BMT-CTN 0402 was a randomized trial (n = 304) comparing 2 GVHD prophylaxis regimens, tacrolimus/sirolimus (Tac/Sir) and tacrolimus/methotrexate (Tac/MTX), in patients with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome undergoing myeloablative HLA-matched HCT. There were no differences in 114-day GVHD-free survival (primary endpoint), aGVHD, cGVHD, relapse, or overall survival (OS) between the 2 arms. Of the 304 patients, 264 had available samples for the current immune reconstitution analysis. Blood samples were collected at 1, 3, 6, 12, and 24 months post-HCT. Multiparameter flow cytometry was performed at the project laboratory (Esoterix Clinical Trials Services) in a blinded fashion, and results for the 2 arms were compared. Multivariable Cox regression models, treating each phenotypic parameter as a time-dependent variable, were constructed to study the impact of reconstitution on clinical outcomes. There were no significant differences in patient and transplantation characteristics between the Tac/Sir and Tac/MTX arms in this analysis. Absolute lymphocyte count and CD3 +  cell, CD4 +  cell, and conventional T cell (Tcon) counts were significantly decreased in the Tac/Sir arm for up to 3 months post-HCT, whereas CD8 +  cells recovered even more slowly (up to 6 months) in this arm. Interestingly, there was no clear difference in the absolute number of regulatory T cells (Tregs, defined as CD4 + CD25 +  cells) between the 2 arms at any point post-HCT; however, the Treg:Tcon ratio was significantly greater in the Tac/Sir arm in the first 3 months after HCT. B lymphocyte recovery was significantly compromised in the Tac/Sir arm from 1 month to 6 months after HCT, whereas natural killer cell reconstitution was not affected in the Tac/Sir arm. In the outcomes analysis, higher numbers of CD3 +  cells, CD4 +  cells, CD8 +  cells, and Tregs were associated with better OS. Neither Treg numbers nor the Treg:Tcon ratio was correlated with GVHD. Our findings indicate that Tac/Sir has a more profound T cell suppressive effect than the combination of Tac/MTX in the early post-transplantation period, and particularly compromises the recovery of CD8 +  T cells, which have been implicated in aGVHD. Sirolimus used in vivo with tacrolimus does not appear to result in increased absolute numbers of Tregs, but might have a beneficial effect on the Treg:Tcon balance in the first 3 months after transplantation. Nonetheless, no differences in aGVHD or cGVHD between the 2 arms were observed in the parent randomized trial. Calcineurin-inhibitor free, sirolimus-containing GVHD prophylaxis strategies, incorporating other novel agents, should be investigated further to maximize the potential favorable effect of sirolimus on Treg:Tcon balance in the post-transplantation immune repertoire. Sirolimus significantly compromises B cell recovery in the first 6 months post-HCT, with potential complex effects on cGVHD that merit further study.",2019,"There was no difference in 114-day GVHD free survival (primary endpoint) as well as acute or chronic GVHD, relapse or overall survival between arms.","['myeloablative allogeneic stem-cell transplantation', '264/304 patients had available samples for the current immune reconstitution analysis']","['sirolimus', 'Sirolimus', 'tacrolimus', 'calcineurin inhibitors like tacrolimus', 'rapamycin (mTOR) inhibitor', 'myeloablative HLA-matched transplantation', 'GVHD prophylaxis regimens, tacrolimus/sirolimus (Tac/Sir) versus tacrolimus/methotrexate (Tac/MTX', 'Tacrolimus/Sirolimus with Tacrolimus/Methotrexate', 'Tac/MTX', 'allogeneic hematopoietic cell transplantation (HCT']","['NK cells reconstitution', 'absolute number of regulatory T-cells', '114-day GVHD free survival', 'Blood samples', 'immune reconstitution', 'compromises B-cell recovery', 'patient and transplant characteristics', 'Absolute lymphocyte count (ALC), CD3+, CD4+ and conventional T cell counts', 'higher numbers of CD3+, CD4', 'aGVHD or cGVHD', 'B-lymphocyte recovery', 'overall survival', 'acute or chronic GVHD, relapse or overall survival']","[{'cui': 'C2242529', 'cui_str': 'Allogenic stem cell transplantation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C4505207', 'cui_str': 'Immune Regeneration'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C4521884', 'cui_str': 'Calcineurin inhibitor (disposition)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0242966', 'cui_str': 'Sepsis Syndrome'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}]","[{'cui': 'C0022688', 'cui_str': 'NK Cells'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0039198', 'cui_str': 'T-Cells, Regulatory'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C4505207', 'cui_str': 'Immune Regeneration'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C3544087', 'cui_str': 'Absolute lymphocyte count'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease (disorder)'}, {'cui': 'C0867389', 'cui_str': 'Chronic graft-versus-host disease (disorder)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",,0.0394254,"There was no difference in 114-day GVHD free survival (primary endpoint) as well as acute or chronic GVHD, relapse or overall survival between arms.","[{'ForeName': 'Mahasweta', 'Initials': 'M', 'LastName': 'Gooptu', 'Affiliation': 'Division of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, Massachusetts. Electronic address: mahasweta_gooptu@dfci.harvard.edu.'}, {'ForeName': 'Haesook T', 'Initials': 'HT', 'LastName': 'Kim', 'Affiliation': 'Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Howard', 'Affiliation': 'Center for International Blood and Marrow Transplant Research, Minneapolis, Minnesota.'}, {'ForeName': 'Sung W', 'Initials': 'SW', 'LastName': 'Choi', 'Affiliation': 'Blood and Marrow Transplantation Program, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Soiffer', 'Affiliation': 'Division of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Joseph H', 'Initials': 'JH', 'LastName': 'Antin', 'Affiliation': 'Division of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Ritz', 'Affiliation': ""Dana-Farber/Boston Children's Cancer and Blood Disorders Center, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Corey S', 'Initials': 'CS', 'LastName': 'Cutler', 'Affiliation': 'Division of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, Massachusetts.'}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2019.06.029']
300,32317575,Forgot calcium? Admission ionized-calcium in two civilian randomized controlled trials of prehospital plasma for traumatic hemorrhagic shock.,"BACKGROUND


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


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


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


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


Therapeutic, level II.",2020,"Prehospital plasma recipients had significantly higher rates of hypocalcemia compared with controls (53% vs. 36%; adjusted relative risk, 1.48; 95% confidence interval [CI], 1.03-2.12; p = 0.03).","['160 subjects (76% men', 'Adults with traumatic hemorrhagic shock (systolic blood pressure ≤70 mm Hg or 71-90 mm Hg + heart rate ≥108 bpm) were eligible', ' 48% received prehospital plasma (median age, 40 years [interquartile range, 28-53 years]) and 71% suffered blunt trauma (median Injury Severity Score [ISS], 22 [interquartile range, 17-34', 'traumatic hemorrhagic shock', 'We studied patients enrolled in two institutions participating in prehospital plasma RCTs (control, standard of care; experimental, plasma), with i-Ca collected before calcium supplementation']",[],"['massive transfusion', 'survival', 'Severe hypocalcemia', 'rates of hypocalcemia', 'Hypocalcemia']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0036982', 'cui_str': 'Hemorrhagic shock'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439385', 'cui_str': 'beats/min'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043253', 'cui_str': 'Blunt injury'}, {'cui': 'C0021504', 'cui_str': 'Injury severity score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0373561', 'cui_str': 'Calcium electrolyte'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy'}]",[],"[{'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}]",160.0,0.491442,"Prehospital plasma recipients had significantly higher rates of hypocalcemia compared with controls (53% vs. 36%; adjusted relative risk, 1.48; 95% confidence interval [CI], 1.03-2.12; p = 0.03).","[{'ForeName': 'Hunter B', 'Initials': 'HB', 'LastName': 'Moore', 'Affiliation': 'From the School of Medicine, Department of Surgery, University of Colorado Anschutz Medical Campus (H.B.M., E.E.M., M.J.C., M.P.C., A.S.), Aurora, CO; University of Colorado Anschutz Medical Campus, School of Public Health, Department of Health Systems, Management and Policy (A.S.); Aurora, Colorado; University of Pittsburgh (M.T.T., J.L.S., F.X.G., J.B.B., M.N., B.Z.), Pittsburgh, Pennsylvania; Ernest E. Moore Shock Trauma Center at Denver Health (E.E.M., M.J.C.), Denver, Colorado; and Combat Casualty Care Research Program (A.E.P.), US Army Medical Research Materiel Command, Fort Detrick, Maryland.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Tessmer', 'Affiliation': ''}, {'ForeName': 'Ernest E', 'Initials': 'EE', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Sperry', 'Affiliation': ''}, {'ForeName': 'Mitchell J', 'Initials': 'MJ', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Chapman', 'Affiliation': ''}, {'ForeName': 'Anthony E', 'Initials': 'AE', 'LastName': 'Pusateri', 'Affiliation': ''}, {'ForeName': 'Francis X', 'Initials': 'FX', 'LastName': 'Guyette', 'Affiliation': ''}, {'ForeName': 'Joshua B', 'Initials': 'JB', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Neal', 'Affiliation': ''}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Zuckerbraun', 'Affiliation': ''}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Sauaia', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002614']
301,32312713,Randomized Phase IIB Trial of the Lignan Secoisolariciresinol Diglucoside in Premenopausal Women at Increased Risk for Development of Breast Cancer.,"We conducted a multiinstitutional, placebo-controlled phase IIB trial of the lignan secoisolariciresinol diglucoside (SDG) found in flaxseed. Benign breast tissue was acquired by random periareolar fine needle aspiration (RPFNA) from premenopausal women at increased risk for breast cancer. Those with hyperplasia and ≥2% Ki-67 positive cells were eligible for randomization 2:1 to 50 mg SDG/day (Brevail) versus placebo for 12 months with repeat bio-specimen acquisition. The primary endpoint was difference in change in Ki-67 between randomization groups. A total of 180 women were randomized, with 152 ultimately evaluable for the primary endpoint. Median baseline Ki-67 was 4.1% with no difference between arms. Median Ki-67 change was -1.8% in the SDG arm ( P  = 0.001) and -1.2% for placebo ( P  = 0.034); with no significant difference between arms. As menstrual cycle phase affects proliferation, secondary analysis was performed for 117 women who by progesterone levels were in the same phase of the menstrual cycle at baseline and off-study tissue sampling. The significant Ki-67 decrease persisted for SDG (median = -2.2%;  P  = 0.002) but not placebo (median = -1.0%). qRT-PCR was performed on 77 pairs of tissue specimens. Twenty-two had significant ERα gene expression changes (<0.5 or >2.0) with 7 of 10 increases in placebo and 10 of 12 decreases for SDG ( P  = 0.028), and a difference between arms ( P  = 0.017). Adverse event incidence was similar in both groups, with no evidence that 50 mg/day SDG is harmful. Although the proliferation biomarker analysis showed no difference between the treatment group and the placebo, the trial demonstrated use of SDG is tolerable and safe.",2020,Median Ki-67 change was -1.8% in the SDG arm (P=0.001) and -1.2% for placebo (P=0.034); with no significant difference between arms.,"['Pre-menopausal Women at Increased Risk for Development of Breast Cancer', '117 women who by progesterone levels', '180 women were randomized, with 152 ultimately evaluable for the primary endpoint', 'Those with hyperplasia and ≥2% Ki-67 positive cells']","['SDG', 'RT-qPCR', 'Lignan Secoisolariciresinol Diglucoside', 'random periareolar fine needle aspiration (RPFNA', 'lignan secoisolariciresinol diglucoside (SDG', 'placebo']","['SDG', 'change in Ki-67', 'Adverse event incidence', 'ERα gene expression changes', 'Median Ki-67 change', 'Median baseline Ki-67']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0428409', 'cui_str': 'Progesterone level'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}, {'cui': 'C0439178', 'cui_str': '% positive cells'}]","[{'cui': 'C0290196', 'cui_str': 'secoisolariciresinol diglucoside'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0064971', 'cui_str': 'Lignans'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1510483', 'cui_str': 'Fine needle aspiration biopsy - action'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0290196', 'cui_str': 'secoisolariciresinol diglucoside'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",180.0,0.408017,Median Ki-67 change was -1.8% in the SDG arm (P=0.001) and -1.2% for placebo (P=0.034); with no significant difference between arms.,"[{'ForeName': 'Carol J', 'Initials': 'CJ', 'LastName': 'Fabian', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Seema A', 'Initials': 'SA', 'LastName': 'Khan', 'Affiliation': 'Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Judy E', 'Initials': 'JE', 'LastName': 'Garber', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Dooley', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Lisa D', 'Initials': 'LD', 'LastName': 'Yee', 'Affiliation': 'Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Klemp', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Nydegger', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Kandy R', 'Initials': 'KR', 'LastName': 'Powers', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Kreutzjans', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Carola M', 'Initials': 'CM', 'LastName': 'Zalles', 'Affiliation': 'Department of Pathology, Boca Raton Hospital, Boca Raton, Florida.'}, {'ForeName': 'Trina', 'Initials': 'T', 'LastName': 'Metheny', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Teresa A', 'Initials': 'TA', 'LastName': 'Phillips', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Jinxiang', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Devin C', 'Initials': 'DC', 'LastName': 'Koestler', 'Affiliation': 'Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Prabhakar', 'Initials': 'P', 'LastName': 'Chalise', 'Affiliation': 'Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Nanda Kumar', 'Initials': 'NK', 'LastName': 'Yellapu', 'Affiliation': 'Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Jernigan', 'Affiliation': 'University of Kansas Cancer Center, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Brian K', 'Initials': 'BK', 'LastName': 'Petroff', 'Affiliation': 'Veterinary Diagnostic Laboratory, Michigan State University, Lansing, Michigan.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Hursting', 'Affiliation': 'Department of Nutrition, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Bruce F', 'Initials': 'BF', 'LastName': 'Kimler', 'Affiliation': 'Department of Radiation Oncology, University of Kansas Medical Center, Kansas City, Kansas. bkimler@kumc.edu.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-20-0050']
302,32318777,Cyclosporine A prevents cardiac arrest-induced acute respiratory failure: a post-hoc analysis of the CYRUS trial.,,2020,,[],['Cyclosporine'],['cardiac arrest-induced acute respiratory failure'],[],"[{'cui': 'C0010592', 'cui_str': 'Cyclosporine'}]","[{'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure'}]",,0.195655,,"[{'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Kreitmann', 'Affiliation': ""Service de Médecine Intensive - Réanimation, Hospices Civils de Lyon, Hôpital Edouard Herriot, 5, place d'Arsonval, 69437, Lyon Cedex 03, France.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Argaud', 'Affiliation': ""Service de Médecine Intensive - Réanimation, Hospices Civils de Lyon, Hôpital Edouard Herriot, 5, place d'Arsonval, 69437, Lyon Cedex 03, France.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Ovize', 'Affiliation': 'Faculté de médecine Lyon Est, Université de Lyon, Université Claude Bernard Lyon 1, 69373, Lyon, France.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Cour', 'Affiliation': ""Service de Médecine Intensive - Réanimation, Hospices Civils de Lyon, Hôpital Edouard Herriot, 5, place d'Arsonval, 69437, Lyon Cedex 03, France. martin.cour@chu-lyon.fr.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-020-06043-0']
303,30899994,Abaloparatide effect on forearm bone mineral density and wrist fracture risk in postmenopausal women with osteoporosis.,"PURPOSE


Wrist fractures are common, contribute significantly to morbidity in women with postmenopausal osteoporosis, and occur predominantly at the ultradistal radius, a site rich in trabecular bone. This exploratory analysis of the phase 3 ACTIVE study evaluated effects of abaloparatide versus placebo and teriparatide on forearm bone mineral density (BMD) and risk of wrist fracture.
METHODS


Forearm BMD was measured by dual energy X-ray absorptiometry in a subset of 982 women from ACTIVE, evenly distributed across the three treatment groups. Wrist fractures were ascertained in the total cohort (N = 2463).
RESULTS


After 18 months, ultradistal radius BMD changes from baseline were 2.25 percentage points greater for abaloparatide compared with placebo (95% confidence interval (CI) 1.38, 3.12, p < 0.001) and 1.54 percentage points greater for abaloparatide compared with teriparatide (95% CI 0.64, 2.45, p < 0.001). At 18 months, 1/3 radius BMD losses (versus baseline) were similar for abaloparatide compared with placebo (-0.42; 95% CI -1.03, 0.20; p = 0.19) but losses with teriparatide exceeded those of placebo (-1.66%; 95% CI -2.27, -1.06; p < 0.001). The decline with abaloparatide was less than that seen with teriparatide (group difference 1.22%; 95% CI 0.57, 1.87; p < 0.001). The radius BMD findings, at both ultradistal and 1/3 sites, are consistent with the numerically lower incidence of wrist fractures observed in women treated with abaloparatide compared with teriparatide (HR = 0.43; 95% CI 0.18, 1.03; p = 0.052) and placebo (HR = 0.49, 95% CI 0.20, 1.19, p = 0.11).
CONCLUSIONS


Compared with teriparatide, abaloparatide increased BMD at the ultradistal radius (primarily trabecular bone) and decreased BMD to a lesser extent at the 1/3 radius (primarily cortical bone), likely contributing to the numerically lower wrist fracture incidence observed with abaloparatide.",2019,"After 18 months, ultradistal radius BMD changes from baseline were 2.25 percentage points greater for abaloparatide compared with placebo (95% confidence interval (CI) 1.38, 3.12, p < 0.001) and 1.54 percentage points greater for abaloparatide compared with teriparatide (95% CI 0.64, 2.45, p < 0.001).","['982 women from ACTIVE, evenly distributed across the three treatment groups', 'postmenopausal women with osteoporosis', 'women with postmenopausal osteoporosis']","['abaloparatide versus placebo and teriparatide', 'placebo', 'teriparatide']","['Wrist fractures', 'BMD', 'forearm bone mineral density (BMD) and risk of wrist fracture', 'wrist fractures', 'radius BMD losses', 'ultradistal radius BMD changes', 'forearm bone mineral density and wrist fracture risk', 'decline with abaloparatide', 'radius BMD findings']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0029458', 'cui_str': 'Postmenopausal Bone Loss'}]","[{'cui': 'C4042342', 'cui_str': 'abaloparatide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0070093', 'cui_str': 'Teriparatide'}]","[{'cui': 'C0435630', 'cui_str': 'Fracture of distal end of radius and ulna (disorder)'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1306504', 'cui_str': 'Radius (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C4042342', 'cui_str': 'abaloparatide'}, {'cui': 'C2607943', 'cui_str': 'findings'}]",,0.361972,"After 18 months, ultradistal radius BMD changes from baseline were 2.25 percentage points greater for abaloparatide compared with placebo (95% confidence interval (CI) 1.38, 3.12, p < 0.001) and 1.54 percentage points greater for abaloparatide compared with teriparatide (95% CI 0.64, 2.45, p < 0.001).","[{'ForeName': 'N B', 'Initials': 'NB', 'LastName': 'Watts', 'Affiliation': 'Mercy Health Osteoporosis and Bone Health Services, Cincinnati, OH, USA. nelson.watts@hotmail.com.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Hattersley', 'Affiliation': 'Radius Health, Inc., Waltham, MA, USA.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Fitzpatrick', 'Affiliation': 'Radius Health, Inc., Waltham, MA, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Radius Health, Inc., Waltham, MA, USA.'}, {'ForeName': 'G C', 'Initials': 'GC', 'LastName': 'Williams', 'Affiliation': 'Radius Health, Inc., Waltham, MA, USA.'}, {'ForeName': 'P D', 'Initials': 'PD', 'LastName': 'Miller', 'Affiliation': 'Colorado Center for Bone Research, Lakewood, CO, USA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Cosman', 'Affiliation': 'Columbia University College of Physicians and Surgeons, New York, NY, USA.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-019-04890-2']
304,32271467,Plasma rich in growth factors injection effectiveness for myofascial pain treatment in masticatory muscles. Randomised controlled trial.,"BACKGROUND


Myofascial pain in masticatory muscles is one of the most common temporomandibular disorder. Nowadays, the most usable treatment methods are based on the muscle taut band cell membrane disruption, which releases the taut band. Platelet-rich plasma, made with PRGF Endoret ®  method, gives an opportunity to use platelet-derived growth factors in treatment processes. It has been proven that platelet-derived growth factors can relief pain and activate muscle regeneration.
OBJECTIVE


To test a hypothesis that PRGF injections can be effective for treating myofascial pain in masticatory muscles.
METHODS


Fifty adult patients participated in the study. Participants were randomly divided into two groups. The first group received 1-mL lidocaine injections to trigger point in their masseter muscle. The second group of patients received 1-mL PRGF injections. The patients' pain was measured by using visual analogue scale (VAS).
RESULT


Statistically significant difference in pain levels before the procedure and 4 weeks after it was found in both groups. There was no statistically significant difference between groups in pain levels before the procedure (P = .063) and 2 weeks after it (P = .123); however, statistically significant difference was noticed 4 weeks after the procedure (P < .001). Four weeks after the procedure, patients' average pain in lidocaine group was 3.4 on VAS, and it was 0.9 in PRGF group.
CONCLUSIONS


PRGF injections in masseter muscle affected by myofascial pain syndrome are an effective treatment method. PRGF injections more effectively relief myofascial pain in masseter muscle than lidocaine injections.",2020,"There were no statistically significant difference between groups in pain levels before the procedure (p=0,063) and 2 weeks after it (p=0,123), however, statistically significant difference was noticed 4 weeks after the procedure (p<0,001).","['50 adult patients participated in the study', 'myofascial pain treatment in masticatory muscles']","['lidocaine injections', 'lidocaine', '1ml PRGF injections', 'PRGF injections']","['average pain', 'visual analogue scale (VAS', 'relief myofascial pain', 'pain levels', 'myofascial pain syndrome']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0553642', 'cui_str': 'Myofascial pain'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0024890', 'cui_str': 'Structure of muscle of mastication'}]","[{'cui': 'C4049857', 'cui_str': 'Lidocaine Injection'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0553642', 'cui_str': 'Myofascial pain'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}]",50.0,0.0613336,"There were no statistically significant difference between groups in pain levels before the procedure (p=0,063) and 2 weeks after it (p=0,123), however, statistically significant difference was noticed 4 weeks after the procedure (p<0,001).","[{'ForeName': 'Dovydas', 'Initials': 'D', 'LastName': 'Sakalys', 'Affiliation': 'Department of Maxillofacial Surgery, Faculty of Odontology, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Jan Pavel', 'Initials': 'JP', 'LastName': 'Rokicki', 'Affiliation': 'Department of Maxillofacial Surgery, Faculty of Odontology, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Gintaras', 'Initials': 'G', 'LastName': 'Januzis', 'Affiliation': 'Department of Maxillofacial Surgery, Faculty of Odontology, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Ricardas', 'Initials': 'R', 'LastName': 'Kubilius', 'Affiliation': 'Department of Maxillofacial Surgery, Faculty of Odontology, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}]",Journal of oral rehabilitation,['10.1111/joor.12973']
305,30198757,Development and effects of a self-management efficacy promotion program for adult patients with congenital heart disease.,"BACKGROUND


With the recent advances in medicine, patients with congenital heart disease are surviving to adulthood. Adults with congenital heart disease must practice self-management to recognize the symptoms of complications and the appropriate response.
AIMS


The purpose of this study was to develop a self-management efficacy promotion program for adults with congenital heart disease and to test the effects of the developed program on disease-related knowledge, self-management implementation and health-related quality of life.
METHODS


A non-equivalent, control group, pre-post test design was used. The intervention group received the self-management efficacy promotion program for six weeks. The control group received only the usual care.
RESULTS


The study results showed that disease-related knowledge ( F=91.095, p<0.001) was significantly different between the two groups, as was the self-management performance ( F=11.846, p<0.001). However, health-related quality of life (generic core scale: F=0.023, p=0.881, cardiac module scale: F=0.174, p=0.678) was not significantly different between groups.
CONCLUSION


The self-management efficacy promotion program for adults with congenital heart disease had a significant effect on disease-related knowledge and self-management implementation, but did not affect health-related quality of life.",2019,"The self-management efficacy promotion program for adults with congenital heart disease had a significant effect on disease-related knowledge and self-management implementation, but did not affect health-related quality of life.","['adults with congenital heart disease', 'adult patients with congenital heart disease', 'Adults with congenital heart disease', 'patients with congenital heart disease']",['self-management efficacy promotion program'],"['self-management performance', 'health-related quality of life', 'disease-related knowledge']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0346743,"The self-management efficacy promotion program for adults with congenital heart disease had a significant effect on disease-related knowledge and self-management implementation, but did not affect health-related quality of life.","[{'ForeName': 'Mi-Ja', 'Initials': 'MJ', 'LastName': 'Lee', 'Affiliation': '1 Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Dukyoo', 'Initials': 'D', 'LastName': 'Jung', 'Affiliation': '2 College of Nursing, Ewha Womans University, Seoul, Korea.'}]",European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology,['10.1177/1474515118800099']
306,32030845,"A Prospective, randomized comparative study between ultrasound-guided posterior quadratus lumborum block and ultrasound-guided ilioinguinal/iliohypogastric nerve block for pediatric inguinal herniotomy.","BACKGROUND


Ilioinguinal/iliohypogastric nerve block is commonly performed to control postherniotomy pain. The posterior quadratus lumborum block has been recently described as an effective analgesic technique for pediatric low abdominal surgery. No data were found regarding the use of posterior quadratus lumborum block in comparison with the traditional ilioinguinal/iliohypogastric nerve block in pediatric inguinal surgery.
AIM


This randomized assessor-blinded study compared postoperative analgesic effects between ultrasound-guided posterior quadratus lumborum block and ilioinguinal/iliohypogastric nerve block in pediatric inguinal herniotomy.
METHODS


One- to seven-year-old children scheduled for unilateral open herniotomy were randomly assigned to receive either ultrasound-guided posterior quadratus lumborum block with 0.25% bupivacaine 0.5 mL/kg or ultrasound-guided ilioinguinal/iliohypogastric nerve block with 0.25% bupivacaine 0.2 mL/kg after induction of general anesthesia. The primary outcome was the proportion of patients who received postoperative oral acetaminophen. The required fentanyl in the recovery room, 24-hour acetaminophen consumption, success rate of regional blocks, block performance data, block-related complications, postoperative pain intensity, and parental satisfaction were assessed.
RESULTS


This study included 40 patients after excluding four cases who were ineligible. The number of patients who required postoperative oral acetaminophen was significantly lower in the posterior quadratus lumborum block group (15.8% vs 52.6%; OR: 5.9; 95% CI: 1.3, 27.3; P = .022). The pain scores at 30 minutes, 1, 2, 6, 12, and 24 hours were similar between groups. There was no evidence of between-group differences in block performance time, the number of needle passes, block-related complications, and parental satisfaction.
CONCLUSION


The posterior quadratus lumborum block with 0.25% bupivacaine 0.5 mL/kg provided better pain control than the ilioinguinal/iliohypogastric nerve block with 0.25% bupivacaine 0.2 mL/kg after open herniotomy in children. The ultrasound guidance technique for the posterior quadratus lumborum block is safe and as simple as the ultrasound-guided ilioinguinal/iliohypogastric nerve block for pediatric patients.",2020,"There was no evidence of between-group differences in block performance time, the number of needle passes, block-related complications and parental satisfaction.
","['pediatric patients', 'Pediatric Inguinal Herniotomy', '40 patients after excluding four cases who were ineligible', 'One to seven-year-old children scheduled for unilateral open herniotomy']","['ultrasound-guided posterior quadratus lumborum block and ilioinguinal/iliohypogastric nerve block', 'ultrasound-guided posterior quadratus lumborum block with 0.25% bupivacaine 0.5 ml/kg or ultrasound-guided ilioinguinal/iliohypogastric nerve block with 0.25% bupivacaine 0.2 ml/kg after induction of general anesthesia', 'Ultrasound-Guided Posterior Quadratus Lumborum Block and Ultrasound-Guided Ilioinguinal/Iliohypogastric Nerve Block', 'bupivacaine']","['number of patients who required postoperative oral acetaminophen', 'proportion of patients who received postoperative oral acetaminophen', 'block performance time, the number of needle passes, block-related complications and parental satisfaction', 'pain control', 'pain scores', 'recovery room, 24-hour acetaminophen consumption, success rate of regional blocks, block performance data, block-related complications, postoperative pain intensity, and parental satisfaction']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018246', 'cui_str': 'Groin'}, {'cui': 'C0405600', 'cui_str': 'Simple excision of inguinal hernial sac (procedure)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0394767', 'cui_str': 'Local anesthetic block of iliohypogastric nerve (procedure)'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia (procedure)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",40.0,0.214158,"There was no evidence of between-group differences in block performance time, the number of needle passes, block-related complications and parental satisfaction.
","[{'ForeName': 'Artid', 'Initials': 'A', 'LastName': 'Samerchua', 'Affiliation': 'Department of Anesthesiology, Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Prangmalee', 'Initials': 'P', 'LastName': 'Leurcharusmee', 'Affiliation': 'Department of Anesthesiology, Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Kachain', 'Initials': 'K', 'LastName': 'Panichpichate', 'Affiliation': 'Department of Anesthesiology, Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Nutchanart', 'Initials': 'N', 'LastName': 'Bunchungmongkol', 'Affiliation': 'Department of Anesthesiology, Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Mullika', 'Initials': 'M', 'LastName': 'Wanvoharn', 'Affiliation': 'Department of Anesthesiology, Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Kanokkan', 'Initials': 'K', 'LastName': 'Tepmalai', 'Affiliation': 'Pediatric Division, Department of Surgery, Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Jiraporn', 'Initials': 'J', 'LastName': 'Khorana', 'Affiliation': 'Pediatric Division, Department of Surgery, Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Sireekarn', 'Initials': 'S', 'LastName': 'Chantakhow', 'Affiliation': 'Pediatric Division, Department of Surgery, Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}]",Paediatric anaesthesia,['10.1111/pan.13837']
307,32320002,How oro-sensory exposure and eating rate affect satiation and associated endocrine responses-a randomized trial.,"BACKGROUND


Longer oral processing decreases food intake. This can be attributed to greater oro-sensory exposure (OSE) and a lower eating rate (ER). How these factors contribute to food intake, and the underlying physiological mechanisms, remain unclear.
OBJECTIVES


We aimed to determine the independent and simultaneous effects of OSE and ER on satiation and associated endocrine responses.
METHODS


Forty participants in study 1 [mean ± SD age: 24 ± 4 y; BMI (in kg/m2): 22 ± 2] and 20 in study 2 (mean ± SD age: 23 ± 3 y; BMI: 23 ± 2) participated in a 2 × 2 randomized trial. In both studies, participants ate chocolate custard with added caramel sauce (low OSE) or caramel fudge (high OSE) and with short (fast ER) or long breaks (slow ER) in between bites, until fullness. In study 2, endocrine responses were measured during the meal.
RESULTS


In study 1, participants ate (mean ± SEM) 42 ± 15 g less in the slow- than in the fast-ER condition, only within the high-OSE condition (P = 0.04). In study 2, participants ate 66 ± 21 g less in the high- than in the low-OSE condition and there were no intake differences between slow and fast ER (P = 0.35). Eight minutes after starting to eat, insulin concentrations increased by 42%-65% in all treatments compared with the control. At the end of the meal, insulin concentrations were 81% higher in the high-OSE, slow-ER than in the low-OSE, fast-ER condition (P = 0.049). Pancreatic polypeptide (PP) increased by 62%, 5 min after meal onset in the low-OSE, fast-ER condition (P = 0.005). Ghrelin concentrations did not change.
CONCLUSIONS


Greater OSE increases insulin responsiveness. In contrast, PP responses are stronger when OSE is reduced and ER is fast. Insulin and PP responses may mediate the independent effects of OSE and ER on food intake. These may be beneficial eating strategies, particularly for type 2 diabetic patients, to control food intake and maintain glucose homeostasis.This trial was registered at trialregister.nl as NL6544.",2020,"Eight minutes after starting to eat, insulin concentrations increased by 42%-65% in all treatments compared with the control.","['participants ate (mean\xa0±\xa0SEM) 42\xa0±\xa015 g less in the slow- than in the fast-ER condition, only within the high-OSE condition (P\xa0=\xa00.04', 'SD age: 24\xa0±\xa04\xa0y', 'Forty participants in study 1 [mean\xa0±', ' BMI: 23\xa0±\xa02) participated in a 2\xa0×\xa02 randomized trial']","['chocolate custard with added caramel sauce (low OSE) or caramel fudge (high OSE) and with short (fast ER) or long breaks (slow ER', 'OSE', 'OSE and ER']","['Ghrelin concentrations', 'insulin concentrations', 'BMI', 'eating rate (ER', 'Insulin and PP responses', 'OSE increases insulin responsiveness', 'Pancreatic polypeptide (PP']","[{'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C4517407', 'cui_str': '0.04'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0453512', 'cui_str': 'Custard'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0108509', 'cui_str': 'Caramel'}, {'cui': 'C0453357', 'cui_str': 'Sauce'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0458193', 'cui_str': 'Fudge'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0439834', 'cui_str': 'Slow'}]","[{'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0030298', 'cui_str': 'Pancreatic peptide'}]",,0.0776592,"Eight minutes after starting to eat, insulin concentrations increased by 42%-65% in all treatments compared with the control.","[{'ForeName': 'Marlou', 'Initials': 'M', 'LastName': 'Lasschuijt', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University & Research, Wageningen, Netherlands.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Mars', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University & Research, Wageningen, Netherlands.'}, {'ForeName': 'Cees', 'Initials': 'C', 'LastName': 'de Graaf', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University & Research, Wageningen, Netherlands.'}, {'ForeName': 'Paul A M', 'Initials': 'PAM', 'LastName': 'Smeets', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University & Research, Wageningen, Netherlands.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa067']
308,32320024,Effect of chicory inulin-type fructan-containing snack bars on the human gut microbiota in low dietary fiber consumers in a randomized crossover trial.,"BACKGROUND


The low intake of dietary fiber compared to recommended amounts has been referred to as the dietary fiber gap. The addition of fiber to snack foods could favorably alter gut microbiota and help individuals meet intake recommendations.
OBJECTIVES


Our objective was to examine the effect of low- and moderate-dose fiber-containing snack bars, comprising mainly chicory root inulin-type fructans (ITF), on gut microbiota in healthy adults with habitual low dietary fiber intake using 16S ribosomal RNA-based approaches.
METHODS


In 2 separate 4-wk, placebo-controlled, double-blind, crossover trials, 50 healthy adults with low dietary fiber intake were randomly assigned to receive isocaloric snack bars of either moderate-dose fiber (7 g/d) or control in Trial 1 (n = 25) or low-dose fiber (3 g/d) or control in Trial 2 (n = 25), with 4-wk washout periods. Fecal microbiota composition and inferred function, fecal SCFA concentration, gastrointestinal (GI) symptoms, dietary intake, and quality of life were measured.
RESULTS


Compared with the control group, the moderate-dose group showed significant differences across multiple microbial taxa, most notably an increased relative abundance of the Bifidobacterium genus from (mean ± SEM) 5.3% ± 5.9% to 18.7% ± 15.0%. With low-dose ITF, significant increases in Bifidobacterium were no longer present after correction for multiple comparisons but targeted analysis with qPCR showed a significant increase in Bifidobacterium. Predictive functional profiling identified changes in predicted function after intake of the moderate- but not the low-dose bar. Fecal SCFAs were affected by time but not treatment. There were no between-group differences in GI symptoms. Importantly, fiber intake increased significantly with the moderate- and low-dose bars.
CONCLUSIONS


In healthy adults, adding 3 or 7 g ITF to snack bars increased Bifidobacterium, a beneficial member of the gut microbial community. The addition of ITF to food products could help reduce the dietary fiber gap prevalent in modern life.This trial was registered at clinicaltrials.gov as NCT03042494.",2020,"With low-dose ITF, significant increases in Bifidobacterium were no longer present after correction for multiple comparisons but targeted analysis with qPCR showed a significant increase in Bifidobacterium.","['healthy adults', '50 healthy adults with low dietary fiber intake', 'healthy adults with habitual low dietary fiber intake using 16S ribosomal RNA-based approaches']","['isocaloric snack bars of either moderate-dose fiber (7 g/d) or control in Trial 1 (n\xa0=\xa025) or low-dose fiber', 'chicory inulin-type fructan-containing snack bars', 'low- and moderate-dose fiber-containing snack bars, comprising mainly chicory root inulin-type fructans (ITF', 'placebo']","['relative abundance', 'Fecal SCFAs', 'fiber intake', 'GI symptoms', 'Fecal microbiota composition and inferred function, fecal SCFA concentration, gastrointestinal (GI) symptoms, dietary intake, and quality of life', 'Bifidobacterium']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0474451', 'cui_str': 'Dietary fiber intake'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0035701', 'cui_str': 'Ribosomal RNA'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0242868', 'cui_str': 'Chicory'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0016743', 'cui_str': 'Levans'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C3537684', 'cui_str': 'chicory root extract'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}]",50.0,0.151477,"With low-dose ITF, significant increases in Bifidobacterium were no longer present after correction for multiple comparisons but targeted analysis with qPCR showed a significant increase in Bifidobacterium.","[{'ForeName': 'Raylene A', 'Initials': 'RA', 'LastName': 'Reimer', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Soto-Vaca', 'Affiliation': 'General Mills Bell Institute of Health and Nutrition, Golden Valley, MN, USA.'}, {'ForeName': 'Alissa C', 'Initials': 'AC', 'LastName': 'Nicolucci', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Shyamchand', 'Initials': 'S', 'LastName': 'Mayengbam', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Heekuk', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Columbia University, New York, NY, USA.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Madsen', 'Affiliation': 'Division of Gastroenterology, Centre of Excellence for Gastrointestinal Inflammation and Immunity Research, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Menon', 'Affiliation': 'General Mills Bell Institute of Health and Nutrition, Golden Valley, MN, USA.'}, {'ForeName': 'Elaine E', 'Initials': 'EE', 'LastName': 'Vaughan', 'Affiliation': 'Sensus BV (Royal Cosun), Roosendaal, Netherlands.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa074']
309,32243363,"Efficacy of photodynamic therapy and periodontal treatment in patients with gingivitis and fixed orthodontic appliances: Protocol of randomized, controlled, double-blind study.","It is known that the presence of orthodontic brackets predisposes for a change in the biofilm, facilitating the development of gingivits. The sites are difficult to access with a toothbrush and periodontal curette, worsening inflammation, in addition, a gingival hyperplasia is associated with poor hygiene. The objective of this study is to evaluate the impact of photodinamyc therapy (PDT) as an adjuvant treatment, considering clinical immunoregulatory and microbiological parameters. This randomized, controlled, double-blind clinical study will include 34 patients, both genders, having used fixed appliance for more than 12 months, with gingivitis. Participants will be divided into two groups: G1 (n = 17)- Scaling and Root Planing + PDT placebo and G2 (n = 17)- Scaling and Root Planing + PDT. In G2 the following dosimetric parameters will be used: methylene blue 0.005%, λ= 660 nanometers (nm), 9 Joules (J) per site, irradiance= 3.5Watts (W)/ centimeters (cm), radiant exposure= 318J/cm. All participants will receive oral hygiene guidance prior the curetes scaling. The clinical periodontal data to be analyzed are plaque index, gingival index and probing depth. Crevicular fluid, from 4 pre-determined sites and saliva, will be collected and analysed for IL-6, IL-1β, IL-8, TNF-α and IL-10 cytokines using ELISA (Enzyme immunoabsorption assay) method. Total Bacteria count will also be performed, by qPCR and Universal16SrRNA gene. All analysis will be realized using in the baseline (T0), 7 (T1) and 21 (T2) days after treatment. Oral health-related quality of life will be assessed using the OHIP-14 questionnaire at times T0 and T2. If sample distribution is normal, the Student T-test will be applied if it is not normal, the Mann-Whitney test will be used. The data will be presented in terms of ± PD and The significance level will be set at p < 0.05. Our results may improve quality of life and add data to establish a therapeutic alternative for gingivitis during the orthodontic treatment. Registration: clinicaltrials.gov NCT04037709. https://clinicaltrials.gov/ct2/show/NCT04037709 - Registered in July 2019.",2020,Oral health-related quality of life will be assessed using the OHIP-14 questionnaire at times T0 and T2.,"['34 patients, both genders, having used fixed appliance for more than 12 months, with gingivitis', 'patients with gingivitis and fixed orthodontic appliances']","['photodinamyc therapy (PDT', 'G1 (n\u200a=\u200a17)- Scaling and Root Planing + PDT placebo and G2 (n\u200a=\u200a17)- Scaling and Root Planing + PDT', 'https://clinicaltrials.gov/ct2/show/NCT04037709', 'photodynamic therapy and periodontal treatment']","['quality of life', 'Total Bacteria count', 'Oral health-related quality of life', 'plaque index, gingival index and probing depth']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008684', 'cui_str': 'Chronic gingivitis'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",34.0,0.202244,Oral health-related quality of life will be assessed using the OHIP-14 questionnaire at times T0 and T2.,"[{'ForeName': 'Ellen Perim', 'Initials': 'EP', 'LastName': 'Rosa', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE, São Paulo, Brazil.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Murakami-Malaquias-Silva', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE, São Paulo, Brazil.'}, {'ForeName': 'Tânia Oppido', 'Initials': 'TO', 'LastName': 'Schalch', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE, São Paulo, Brazil.'}, {'ForeName': 'Daniela Bezerra', 'Initials': 'DB', 'LastName': 'Teixeira', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE, São Paulo, Brazil.'}, {'ForeName': 'Ricardo Fidos', 'Initials': 'RF', 'LastName': 'Horliana', 'Affiliation': 'Academic specialization student in Temporomandibular Disorder and Orofacial pain.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Tortamano', 'Affiliation': 'Department of Orthodontics, School of Dentistry, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Isabel Peixoto', 'Initials': 'IP', 'LastName': 'Tortamano', 'Affiliation': 'Department of Stomatology, School of Dentistry, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Inês Aparecida', 'Initials': 'IA', 'LastName': 'Buscariolo', 'Affiliation': 'Department of Stomatology, School of Dentistry, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Priscila Larcher', 'Initials': 'PL', 'LastName': 'Longo', 'Affiliation': 'Postgraduate Program of Aging Science -São Judas Tadeu University - São Paulo, SP, Brazil.'}, {'ForeName': 'Renata Matalon', 'Initials': 'RM', 'LastName': 'Negreiros', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE, São Paulo, Brazil.'}, {'ForeName': 'Sandra Kalil', 'Initials': 'SK', 'LastName': 'Bussadori', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE, São Paulo, Brazil.'}, {'ForeName': 'Lara Jansiski', 'Initials': 'LJ', 'LastName': 'Motta', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE, São Paulo, Brazil.'}, {'ForeName': 'Anna Carolina Ratto Tempestini', 'Initials': 'ACRT', 'LastName': 'Horliana', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE, São Paulo, Brazil.'}]",Medicine,['10.1097/MD.0000000000019429']
310,32243365,Effects of anodal transcranial direct current stimulation over the contralesional hemisphere on motor recovery in subacute stroke patients with severe upper extremity hemiparesis: Study protocol for a randomized controlled trial.,"INTRODUCTION


Upper extremity motor impairment is one of the major sequelae of stroke, resulting in limitations of activities of daily living. Recently, contralesional cortical activation has been reported to be important for motor recovery in stroke patients with severe upper extremity hemiparesis due to the extensive corticospinal tract involvement. We therefore designed this study to investigate the effects of contralesional anodal transcranial direct current stimulation (tDCS), which induces cortical activation, in stroke patients with severe upper extremity motor impairment.
METHODS AND ANALYSIS


We will recruit patients with subacute stroke (<3 months after onset) with unilateral upper extremity weakness who meet the following criteria: Shoulder Abduction and Finger Extension (SAFE) score below 8, Fugl-Meyer Assessment for upper extremity (FMA-UE) score ≤25, and absent motor evoked potential (MEP) response on the affected extensor carpi radialis muscle. Subjects will be randomly allocated to either the intervention (n = 18) or the control group (n = 18). The intervention group will undergo 10 sessions of robotic arm rehabilitation with simultaneous anodal tDCS over the contralesional premotor area, whereas the control group will receive sham tDCS during the same sessions. One daily session consists of 25 minutes.The primary outcome measure of this study is the Fugl-Meyer Assessment score of the upper extremity; the secondary outcome measures are the Korean version of the Modified Barthel Index, the Brunnstrom stage of the affected arm and hand, the Box and Block Test, the Modified Ashworth Scale, the Manual Muscle Power Test, and the patient's encephalographic laterality index.
DISCUSSION


Findings of this study will help to establish an individualized tDCS protocol according to the stroke severity and to find out the EEG parameters to predict the better recovery in subacute stroke patients with severe upper extremity hemiparesis.
ETHICS AND DISSEMINATION


The study was approved by the Seoul National University Bundang Hospital Institutional Review Board (IRB No. B-1806-475-006) and will be carried out in accordance with the approved guidelines. The results of the trial will be submitted for publication in a peer-reviewed journal.",2020,"Recently, contralesional cortical activation has been reported to be important for motor recovery in stroke patients with severe upper extremity hemiparesis due to the extensive corticospinal tract involvement.","['patients with subacute stroke (<3 months after onset) with unilateral upper extremity weakness who meet the following criteria: Shoulder Abduction and Finger Extension (SAFE) score below 8, Fugl-Meyer Assessment for upper extremity (FMA-UE) score ≤25, and absent motor evoked potential (MEP) response on the affected extensor carpi radialis muscle', 'stroke patients with severe upper extremity hemiparesis', 'subacute stroke patients with severe upper extremity hemiparesis', 'stroke patients with severe upper extremity motor impairment']","['contralesional anodal transcranial direct current stimulation (tDCS', 'anodal transcranial direct current stimulation', 'robotic arm rehabilitation with simultaneous anodal tDCS over the contralesional premotor area, whereas the control group will receive sham tDCS']","[""Fugl-Meyer Assessment score of the upper extremity; the secondary outcome measures are the Korean version of the Modified Barthel Index, the Brunnstrom stage of the affected arm and hand, the Box and Block Test, the Modified Ashworth Scale, the Manual Muscle Power Test, and the patient's encephalographic laterality index""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0751409', 'cui_str': 'Monoparesis - arm'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0224265', 'cui_str': 'Structure of extensor carpi radialis muscle'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018989', 'cui_str': 'Hemiparesis'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0336542', 'cui_str': 'Robotic arm'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0228202', 'cui_str': 'Premotor cortex'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023114', 'cui_str': 'Handedness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0509946,"Recently, contralesional cortical activation has been reported to be important for motor recovery in stroke patients with severe upper extremity hemiparesis due to the extensive corticospinal tract involvement.","[{'ForeName': 'Stephanie Hyeyoung', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Won-Seok', 'Initials': 'WS', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Junsik', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Nam-Jong', 'Initials': 'NJ', 'LastName': 'Paik', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000019495']
311,32108022,Medication Adherence During Adjunct Therapy With Statins and ACE Inhibitors in Adolescents With Type 1 Diabetes.,"OBJECTIVE


Suboptimal adherence to insulin treatment is a main issue in adolescents with type 1 diabetes. However, to date, there are no available data on adherence to adjunct noninsulin medications in this population. Our aim was to assess adherence to ACE inhibitors and statins and explore potential determinants in adolescents with type 1 diabetes.
RESEARCH DESIGN AND METHODS


There were 443 adolescents with type 1 diabetes recruited into the Adolescent Type 1 Diabetes Cardio-Renal Intervention Trial (AdDIT) and exposed to treatment with two oral drugs-an ACE inhibitor and a statin-as well as combinations of both or placebo for 2-4 years. Adherence was assessed every 3 months with the Medication Event Monitoring System (MEMS) and pill count.
RESULTS


Median adherence during the trial was 80.2% (interquartile range 63.6-91.8) based on MEMS and 85.7% (72.4-92.9) for pill count. Adherence based on MEMS and pill count dropped from 92.9% and 96.3%, respectively, at the first visit to 76.3% and 79.0% at the end of the trial. The percentage of study participants with adherence ≥75% declined from 84% to 53%. A good correlation was found between adherence based on MEMS and pill count ( r  = 0.82,  P  < 0.001). Factors associated with adherence were age, glycemic control, and country.
CONCLUSIONS


We report an overall good adherence to ACE inhibitors and statins during a clinical trial, although there was a clear decline in adherence over time. Older age and suboptimal glycemic control at baseline predicted lower adherence during the trial, and, predictably, reduced adherence was more prevalent in subjects who subsequently dropped out.",2020,"RESULTS


Median adherence during the trial was 80.2% (interquartile range 63.6-91.8), based on MEMS, and 85.7% (72.4-92.9) for pill count.","['Adolescents With Type 1 Diabetes', 'adolescents with type 1 diabetes', '443 adolescents with type 1 diabetes recruited into the Adolescent Type 1 Diabetes Cardio-renal Intervention Trial (AdDIT) and exposed to treatment with two oral drugs']","['placebo', 'Statins and ACE Inhibitors']","['Adherence based on MEMS and pill count', 'Adherence', 'adherence based on MEMS and pill count', 'Median adherence', 'Medication Adherence']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1979923', 'cui_str': 'Micro-Electro-Mechanical Systems'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}]",443.0,0.0573073,"RESULTS


Median adherence during the trial was 80.2% (interquartile range 63.6-91.8), based on MEMS, and 85.7% (72.4-92.9) for pill count.","[{'ForeName': 'Elżbieta', 'Initials': 'E', 'LastName': 'Niechciał', 'Affiliation': 'Department of Pediatric Diabetes, Endocrinology and Obesity, Poznan University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Carlo L', 'Initials': 'CL', 'LastName': 'Acerini', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge, U.K.'}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Chiesa', 'Affiliation': 'Institute of Cardiovascular Science, University College London, London, U.K.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Stevens', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge, U.K.'}, {'ForeName': 'R Neil', 'Initials': 'RN', 'LastName': 'Dalton', 'Affiliation': ""Evelina Children's Hospital, Guy's and St Thomas' National Health Service Foundation Trust, London, U.K.""}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Daneman', 'Affiliation': 'Department of Paediatrics, The Hospital for Sick Children and University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Deanfield', 'Affiliation': 'Institute of Cardiovascular Science, University College London, London, U.K.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Jones', 'Affiliation': 'Telethon Kids Institute, The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Farid H', 'Initials': 'FH', 'LastName': 'Mahmud', 'Affiliation': 'Department of Paediatrics, The Hospital for Sick Children and University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Sally M', 'Initials': 'SM', 'LastName': 'Marshall', 'Affiliation': 'Institute of Cellular Medicine (Diabetes), Faculty of Clinical Medical Sciences, Newcastle University, Newcastle upon Tyne, U.K.'}, {'ForeName': 'H Andrew W', 'Initials': 'HAW', 'LastName': 'Neil', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology & Metabolism, University of Oxford, Oxford, U.K.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Dunger', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge, U.K.'}, {'ForeName': 'M Loredana', 'Initials': 'ML', 'LastName': 'Marcovecchio', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-0884']
312,32311845,Changes in respiratory mechanics at birth in preterm infants: A pilot study.,"OBJECTIVE


We aimed to measure lung mechanics at birth by the forced oscillation technique (FOT) for assessment of the initial degree of lung aeration and the short-term aeration changes after applying different respiratory support strategies.
METHODS


Eighteen preterm infants (gestational age = 29-36 week) were randomized to receive either continuous positive airway pressure (CPAP) at 5 cmH 2  O only or combined with a sustained inflation (SI; 15 seconds at 25 cmH 2  O after 5 seconds of CPAP) at birth. We assessed the respiratory system reactance at 5 Hz (X 5;  increases with lung volume recruitment at a given distending pressure) at 2, 40, and 150 seconds after initiation of CPAP. k-Means clustering of the initial X 5  value (X 5,i  ) stratified newborn into either infants with lower (lowerX 5,i  ; X 5   < -280 cmH 2  O*s/L) and higher (higherX 5,i  ; X 5   > -240 cmH 2  O*s/L) initial degree of lung volume recruitment.
RESULTS


Initial values were highly heterogeneous. In the LowerX 5,i  group, X 5  increased with time, with SI-patients showing significantly higher values at 150 seconds than the non-SI group (X 5   = -89 ± 27 cmH 2  O vs -274 ± 58 cmH 2  O). In the higherX 5,i  group, X 5  did not improve with time, regardless of the respiratory strategy, suggesting a lack of lung recruitment. Moreover, 75% of infants receiving SI in the higherX 5,i  group experienced a transient loss of aeration after the maneuver.
CONCLUSIONS


Preterm newborns present initially with highly heterogeneous lung aeration at birth that significantly impacts the effectiveness of the subsequent lung volume recruitment strategy. FOT may represent a valuable tool for individualizing a respiratory resuscitation at birth as it is noninvasive and may be applied simultaneously to respiratory support.",2020,"In the higherX 5,i  group, X 5  did not improve with time, regardless of the respiratory strategy, suggesting a lack of lung recruitment.","['Eighteen preterm infants (gestational age\u2009=\u200929-36 week', 'preterm infants']","['continuous positive airway pressure (CPAP) at 5\u2009cmH 2  O only or combined with a sustained inflation (SI; 15\u2009seconds at 25\u2009cmH 2  O after 5\u2009seconds of CPAP', 'FOT', 'forced oscillation technique (FOT']","['respiratory system reactance', 'transient loss of aeration']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0949658', 'cui_str': 'Primary familial hypertrophic cardiomyopathy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0021398', 'cui_str': 'Economic Inflation'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0035237', 'cui_str': 'Structure of respiratory system'}, {'cui': 'C0040704', 'cui_str': 'Transients'}]",18.0,0.0588961,"In the higherX 5,i  group, X 5  did not improve with time, regardless of the respiratory strategy, suggesting a lack of lung recruitment.","[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Veneroni', 'Affiliation': 'TechRes lab, Department of Electronics, Information and bioengineering, Politecnico di Milano University, Milano, Italy.'}, {'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Mercadante', 'Affiliation': ""Neonatal Intensive Care Unit (NICU), Fondazione IRCCS Ca'Granda Foundation, Ospedale Maggiore Policlinico Hospital-Università degli Studi di Milano, Milan, Italy.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lavizzari', 'Affiliation': ""Neonatal Intensive Care Unit (NICU), Fondazione IRCCS Ca'Granda Foundation, Ospedale Maggiore Policlinico Hospital-Università degli Studi di Milano, Milan, Italy.""}, {'ForeName': 'Mariarosa', 'Initials': 'M', 'LastName': 'Colnaghi', 'Affiliation': ""Neonatal Intensive Care Unit (NICU), Fondazione IRCCS Ca'Granda Foundation, Ospedale Maggiore Policlinico Hospital-Università degli Studi di Milano, Milan, Italy.""}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Mosca', 'Affiliation': ""Neonatal Intensive Care Unit (NICU), Fondazione IRCCS Ca'Granda Foundation, Ospedale Maggiore Policlinico Hospital-Università degli Studi di Milano, Milan, Italy.""}, {'ForeName': 'Raffaele L', 'Initials': 'RL', 'LastName': 'Dellacà', 'Affiliation': 'TechRes lab, Department of Electronics, Information and bioengineering, Politecnico di Milano University, Milano, Italy.'}]",Pediatric pulmonology,['10.1002/ppul.24772']
313,32311921,Study on urinary metabolomics of premenstrual dysphoric disorder patients with liver-qi depression syndrome treated with Xiaoyaosan: Study Protocol Clinical Trial (SPIRIT Compliant).,"INTRODUCTION


Premenstrual dysphoric disorder (PMDD) is a serious form of premenstrual syndrome with mental symptoms as its main manifestation, which seriously affects women's health and daily life. Some basic research and clinical studies have shown that the Chinese herbal medicine of Xiaoyaosan can relieve the symptoms of mental disorders with few side effects. The aim of this study is to evaluate the clinical efficacy of Xiaoyaosan for treating PMDD with liver-qi depression syndrome. In addition, metabonomics and small molecular marker compounds closely related to the pathogenesis of PMDD are expected to be found, and mechanism of Xiaoyaosan is further explored from the metabolic level.
METHODS AND ANALYSIS


This study is a clinical pilot trial. Thirty PMDD patients with liver-qi depression syndrome and thirty healthy participants will be recruited. Study participants will be assigned in a 1:1 ratio to 2 groups: a normal control group and Xiaoyaosan treatment group. The treatment group will receive the Chinese patent medicine of Xiaoyaosan for 3 menstrual cycles. The primary outcome is the syndrome change in the Daily Record of Severity of Problems (DRSP). The secondary outcome is improvement in TCM syndrome, which will be measured with TCM symptom score scale. Urine metabolism profiles of participants by liquid chromatograph-mass spectrometer (LC-MS) method will be measured to explore the mechanism of PMDD pathogenesis and action of Xiaoyaosan on PMDD.
DISCUSSION


This trial will evaluate the effectiveness and the therapeutic mechanism from the metabolomics level of Xiaoyaosan in individuals with PMDD. If successful, the outcome of this trial will provide a viable treatment option for PMDD patients and objective evidence on the efficacy of Xiaoyaosan for PMDD.
ETHICS AND DISSEMINATION


The trial has been approved by the Institutional Ethics Committee of Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine (file number: DZMEC-KY-2019-73). Written informed consent will be obtained from all participants. The results of the study will be published in peer-reviewed journals or communicated via yearly reports to funding bodies.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR1900026296.",2020,The trial has been approved by the Institutional Ethics Committee of Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine (file number: DZMEC-KY-2019-73).,"['Thirty PMDD patients with liver-qi depression syndrome and thirty healthy participants', 'individuals with PMDD', 'PMDD patients', 'premenstrual dysphoric disorder patients with liver-qi depression syndrome treated with']","['Chinese patent medicine of Xiaoyaosan', 'normal control group and Xiaoyaosan treatment group', 'Xiaoyaosan']","['TCM syndrome, which will be measured with TCM symptom score scale', 'urinary metabolomics', 'Urine metabolism profiles', 'syndrome change in the Daily Record of Severity of Problems (DRSP']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0520676', 'cui_str': 'Premenstrual dysphoric disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013231', 'cui_str': 'Drugs, Non-Prescription'}, {'cui': 'C2605266', 'cui_str': 'xiaoyaosan'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2355580', 'cui_str': 'Record of'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]",30.0,0.129672,The trial has been approved by the Institutional Ethics Committee of Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine (file number: DZMEC-KY-2019-73).,"[{'ForeName': 'Mengbai', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'School of Traditional Chinese Medicine, Beijing University of Chinese Medicine.'}, {'ForeName': 'Yanfeng', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'School of Traditional Chinese Medicine, Jinan University, Guangzhou.'}, {'ForeName': 'Chenyue', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'School of Traditional Chinese Medicine, Beijing University of Chinese Medicine.'}, {'ForeName': 'Yueyun', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'School of Traditional Chinese Medicine, Beijing University of Chinese Medicine.'}, {'ForeName': 'Zhiyi', 'Initials': 'Z', 'LastName': 'Yan', 'Affiliation': 'School of Traditional Chinese Medicine, Beijing University of Chinese Medicine.'}, {'ForeName': 'Yajing', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': 'School of Traditional Chinese Medicine, Beijing University of Chinese Medicine.'}, {'ForeName': 'Xiaojuan', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'School of Traditional Chinese Medicine, Jinan University, Guangzhou.'}, {'ForeName': 'Qingyu', 'Initials': 'Q', 'LastName': 'Ma', 'Affiliation': 'School of Traditional Chinese Medicine, Jinan University, Guangzhou.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'School of Traditional Chinese Medicine, Jinan University, Guangzhou.'}, {'ForeName': 'Liuqing', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Jiuzhitang Co., Ltd., Changsha, China.'}, {'ForeName': 'Jiaxu', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'School of Traditional Chinese Medicine, Beijing University of Chinese Medicine.'}]",Medicine,['10.1097/MD.0000000000019425']
314,32302056,Relative bioavailability of a pediatric dispersible tablet and adult film-coated tablet of macitentan in healthy volunteers.,"To compare the pharmacokinetic (PK) properties of the pediatric dispersible tablet formulation of macitentan and the adult film-coated tablet formulation of macitentan in healthy subjects. A randomized, open-label, single-dose, two-sequence, two-period, crossover, Phase 1 study was conducted in 12 healthy adults. Subjects were randomized to one of the two possible treatment sequences A/B or B/A on Day 1 under fasted conditions. Treatment A was a single 10 mg dose of macitentan (film-coated adult formulation) and Treatment B was a single 10 mg dose of macitentan, consisting of two 5 mg dispersible tablets (pediatric formulation). PK sampling over 216 hours was conducted, and PK parameters were derived using non-compartmental methods. For macitentan, geometric means ratio of peak plasma concentrations (C max  ), plasma concentration-time curve from zero to the time of the last quantifiable concentration (AUC 0-   t  ), and plasma concentration-time curve from zero to infinity (AUC 0-∞  ) were 1.140, 0.974, and 0.974, respectively. The corresponding 90% confidence intervals fell entirely within the referenced range of 0.8000 to 1.2500, which is used for evaluation of bioequivalence. These results indicate no significant differences between the pediatric dispersible tablet and the adult film-coated tablet. Both formulations were well tolerated. The pediatric dispersible tablet is biocomparable to the adult film-coated tablet formulation.",2020,Both formulations were well tolerated.,"['healthy volunteers', '12 healthy adults', 'healthy subjects']",['pediatric dispersible tablet and adult film-coated tablet of macitentan'],"['Relative bioavailability', 'tolerated', 'pharmacokinetic (PK) properties', 'plasma concentration-time curve', 'For macitentan, geometric means ratio of peak plasma concentrations (C max  ), plasma concentration-time curve']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0991504', 'cui_str': 'Disintegrating Oral Tablet'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1273643', 'cui_str': 'Film-coated tablet'}, {'cui': 'C2606556', 'cui_str': 'Macitentan'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C2606556', 'cui_str': 'Macitentan'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",12.0,0.0220696,Both formulations were well tolerated.,"[{'ForeName': 'Patricia N', 'Initials': 'PN', 'LastName': 'Sidharta', 'Affiliation': 'Idorsia Pharmaceuticals Ltd., Allschwil, Switzerland.'}, {'ForeName': 'Radka', 'Initials': 'R', 'LastName': 'Štěpánová', 'Affiliation': 'Aixial s.r.o., Brno, Czech Republic.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Globig', 'Affiliation': 'Idorsia Pharmaceuticals Ltd., Allschwil, Switzerland.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Ulč', 'Affiliation': 'CEPHA s.r.o., Plzeň, Czech Republic.'}, {'ForeName': 'Dénes', 'Initials': 'D', 'LastName': 'Csonka', 'Affiliation': 'Actelion Pharmaceuticals Ltd., Allschwil, Switzerland.'}]",Pharmacology research & perspectives,['10.1002/prp2.580']
315,32318744,Evaluating the Efficacy of Crisaborole Using the Atopic Dermatitis Severity Index and Percentage of Affected Body Surface Area.,"Crisaborole ointment, 2%, is a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild-to-moderate atopic dermatitis. This post hoc analysis pools results from 2 phase 3 studies (ClinicalTrials.gov, NCT02118766 [AD-301]; NCT02118792 [AD-302]) to evaluate crisaborole efficacy in patients ≥ 2 years with mild-to-moderate atopic dermatitis (per Investigator's Static Global Assessment) using the Atopic Dermatitis Severity Index (ADSI) and percentage of treatable body surface area (%BSA). Patients were randomly assigned 2:1 to receive crisaborole (n = 1,016) or vehicle (n = 506) twice daily for 28 days. ADSI scores were the sum of pruritus, erythema, exudation, excoriation, and lichenification severity scores, each graded on a 4-point scale from none (0) to severe (3). Respective mean changes in ADSI score and %BSA at day 29 were (crisaborole vs. vehicle) -3.52 versus -2.42 (p < 0.0001) and -7.43 versus -4.44 (p < 0.0001). Crisaborole was effective in treating mild-to-moderate atopic dermatitis based on ADSI and %BSA.",2020,Crisaborole was effective in treating mild-to-moderate atopic dermatitis based on ADSI and %BSA.,"['mild-to-moderate atopic dermatitis', ""patients ≥\u20092 years with mild-to-moderate atopic dermatitis (per Investigator's Static Global Assessment) using the Atopic Dermatitis Severity Index (ADSI) and percentage of treatable body surface area (%BSA""]","['Crisaborole ointment', 'crisaborole', 'Crisaborole']","['ADSI scores', 'ADSI score and %BSA', 'crisaborole efficacy', 'Atopic Dermatitis Severity Index and Percentage of Affected Body Surface Area', 'pruritus, erythema, exudation, excoriation, and lichenification severity scores']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}]","[{'cui': 'C4301784', 'cui_str': 'crisaborole Topical Ointment'}, {'cui': 'C4301781', 'cui_str': 'crisaborole'}]","[{'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C4301781', 'cui_str': 'crisaborole'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0311437', 'cui_str': 'Exudation'}, {'cui': 'C0015256', 'cui_str': 'Excoriation'}, {'cui': 'C0023653', 'cui_str': 'Lichenification'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}]",,0.0507047,Crisaborole was effective in treating mild-to-moderate atopic dermatitis based on ADSI and %BSA.,"[{'ForeName': 'Jonathan I', 'Initials': 'JI', 'LastName': 'Silverberg', 'Affiliation': 'Department of Dermatology, The George Washington University School of Medicine and Health Sciences, 20052 Washington, DC, USA. E-mail: JonathanISilverberg@gmail.com.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Tallman', 'Affiliation': ''}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Ports', 'Affiliation': ''}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Gerber', 'Affiliation': ''}, {'ForeName': 'Huaming', 'Initials': 'H', 'LastName': 'Tan', 'Affiliation': ''}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Zielinski', 'Affiliation': ''}]",Acta dermato-venereologica,['10.2340/00015555-3489']
316,32315444,Adjunctive effect of mouthrinse on treatment of peri-implant mucositis using mechanical debridement: A randomized clinical trial.,"AIM


To study effect of delmopinol hydrochloride (DEL) in comparison with chlorhexidine digluconate (CHX) and a placebo (PLA) in addition to non-surgical mechanical debridement in patients with peri-implant mucositis.
MATERIALS AND METHODS


Eighty-nine patients with at least one implant diagnosed with peri-implant mucositis were randomly assigned to one of three study groups (DEL, CHX and PLA). Professional non-surgical mechanical debridement was performed at baseline. Mouth rinsing was carried out by the patients twice a day in addition to their regular oral hygiene practices. Assessments of efficacy were performed for the primary outcome - Implant bleeding on probing (IBOP%) and secondary outcomes - modified Bleeding Index (mBI) and modified Plaque Index (mPI) at 1 and 3 months.
RESULTS


At 3 months, there was statistically significant reduction in IBOP% and mBI within the study groups compared to baseline. However, there was no statistically significant difference between the study groups at 3 months follow-up. Moreover, there was a statistically significant difference according to mPI at 1 month between the chlorhexidine and placebo group (p = .004).
CONCLUSIONS


This study confirms that mechanical debridement combined with oral hygiene instruction is effective in treatment of peri-implant mucositis. The clinical effects between groups were comparable.",2020,This study confirms that mechanical debridement combined with oral hygiene instruction is effective in treatment of peri-implant mucositis.,"['Eighty-nine patients with at least one implant diagnosed with peri-implant mucositis', 'patients with peri-implant mucositis']","['mechanical debridement combined with oral hygiene instruction', 'mouthrinse', 'mechanical debridement', 'placebo', 'delmopinol hydrochloride (DEL', 'chlorhexidine', 'placebo (PLA', 'chlorhexidine digluconate (CHX']","['Implant bleeding on probing sites (IBOP%) and secondary outcomes the modified Bleeding Index (mBI), modified Plaque Index (mPI', 'IBOP% and mBI', 'peri-implant mucositis']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3698407', 'cui_str': 'Peri-implant mucositis'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0204131', 'cui_str': 'Oral hygiene education'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0166532', 'cui_str': 'delmopinol'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0055361', 'cui_str': 'Chlorhexidine gluconate'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0449996', 'cui_str': 'Probe location'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C3698407', 'cui_str': 'Peri-implant mucositis'}]",89.0,0.0295568,This study confirms that mechanical debridement combined with oral hygiene instruction is effective in treatment of peri-implant mucositis.,"[{'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Philip', 'Affiliation': 'Department of Oral Implantology and Prosthetic Dentistry, Academic Center for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Marja L', 'Initials': 'ML', 'LastName': 'Laine', 'Affiliation': 'Department of Periodontology, Academic Center for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Daniël', 'Initials': 'D', 'LastName': 'Wismeijer', 'Affiliation': 'Department of Oral Implantology and Prosthetic Dentistry, Academic Center for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}]",Journal of clinical periodontology,['10.1111/jcpe.13295']
317,32315448,Effect of self-performed mechanical plaque control frequency on gingival health in subjects with a history of periodontitis: A Randomized Clinical Trial.,"AIM


This randomized clinical trial evaluated the effect of the frequency of self-performed mechanical plaque control (SPC) on gingival health in subjects with a history of periodontitis.
MATERIALS AND METHODS


Forty-two subjects participating in a routine periodontal maintenance program were randomized to perform SPC at 12-, 24- or 48-hr intervals. Plaque index (PlI) and gingival index (GI) were evaluated at baseline, and days 15, 30 and 90 of study. Probing depths, clinical attachment levels and bleeding on probing were assessed at baseline, days 30 and 90. Mixed linear models were used for the analysis and comparison of experimental groups.
RESULTS


Mean GI at baseline remained unchanged throughout study (90 days) only in the 12-hr group (0.7 ± 0.1 versus 0.8 ± 0.1; p < .05). At the end of study, mean GI was significantly increased in the 48-hr group over that in the 12- and 24-hr groups. When GI = 2 scores were considered, only the 48-hr group failed to maintain gingival health throughout the study (18.8%).
CONCLUSION


SPC performed at a 12- or 24-hr frequency appears sufficient to controlling gingival inflammation whereas this clinical status was not maintained using a 48-hr frequency in subjects with a history of periodontitis subject to a routine periodontal maintenance program (ClinicalTrials.gov: 50208115.9.0000.5346).",2020,Mean GI at baseline remained unchanged throughout study (90 days) only in the 12-hour group (0.7±0.1 vs. 0.8±0.1; p<0.05).,"['Forty-two subjects participating in a routine periodontal maintenance program', 'subjects with a history of periodontitis', 'Subjects with a History of Periodontitis']","['self-performed mechanical plaque control (SPC', 'Self-Performed Mechanical Plaque Control Frequency']","['Probing depths, clinical attachment levels and bleeding on probing', 'maintain gingival health', 'gingival health', 'Gingival Health', 'mean GI', 'Mean GI', 'Plaque index (PlI) and gingival index (GI']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]","[{'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}]",42.0,0.0637548,Mean GI at baseline remained unchanged throughout study (90 days) only in the 12-hour group (0.7±0.1 vs. 0.8±0.1; p<0.05).,"[{'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Maier', 'Affiliation': 'Department of Stomatology, Division of Periodontology, School of Dentistry, Federal University of Santa Maria, Santa Maria, Brazil.'}, {'ForeName': 'Ana Paula Pereira', 'Initials': 'APP', 'LastName': 'Reiniger', 'Affiliation': 'Department of Stomatology, Division of Periodontology, School of Dentistry, Federal University of Santa Maria, Santa Maria, Brazil.'}, {'ForeName': 'Camila Silveira', 'Initials': 'CS', 'LastName': 'Sfreddo', 'Affiliation': 'Department of Stomatology, Division of Periodontology, School of Dentistry, Federal University of Santa Maria, Santa Maria, Brazil.'}, {'ForeName': 'Ulf Me', 'Initials': 'UM', 'LastName': 'Wikesjö', 'Affiliation': 'Laboratory for Applied Periodontal & Craniofacial Research, Adams School of Dentistry, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Karla Zanini', 'Initials': 'KZ', 'LastName': 'Kantorski', 'Affiliation': 'Department of Stomatology, Division of Periodontology, School of Dentistry, Federal University of Santa Maria, Santa Maria, Brazil.'}, {'ForeName': 'Carlos Heitor Cunha', 'Initials': 'CHC', 'LastName': 'Moreira', 'Affiliation': 'Department of Stomatology, Division of Periodontology, School of Dentistry, Federal University of Santa Maria, Santa Maria, Brazil.'}]",Journal of clinical periodontology,['10.1111/jcpe.13297']
318,32282728,Acupuncture for erectile dysfunction in post-stroke patients: Study Protocol Clinical Trial (SPIRIT Compliant).,"INTRODUCTION


Erectile dysfunction refers to the continued inability of the penis to reach and maintain sufficient erections to achieve a satisfactory sex life and last at least 6 months. As part of traditional Chinese medicine, acupuncture has been widely used in clinical practice. In order to evaluate, the exact effect of acupuncture on the clinical efficacy of patients with Post-stroke Erectile dysfunction (PSED), this experiment uses randomized controlled experiments.
METHODS/DESIGN


This pragmatic randomized controlled trial will recruit 103 patients who are diagnosed with PSED. Simple randomization to conventional treatment with a 1:1 allocation ratio will be used. Ten 30-min acupuncture sessions will be provided to patients assigned to the Intervention group. All participants will continue to receive conventional treatment. The selection of outcomes will be evaluated by International Erectile Function Index-5 (IIEF-5) score at week 8.
DISCUSSION


This trial may provide evidence regarding the clinical effectiveness, safety, and cost-effectiveness of acupuncture for patients with PSED.
TRIAL REGISTRATION


ClinicalTrials.gov, ChiCTR2000030231, Registered on February 25, 2020.",2020,"In order to evaluate, the exact effect of acupuncture on the clinical efficacy of patients with Post-stroke Erectile dysfunction (PSED), this experiment uses randomized controlled experiments.
","['patients with PSED', 'post-stroke patients', 'patients with Post-stroke Erectile dysfunction (PSED', '103 patients who are diagnosed with PSED']","['acupuncture', 'Acupuncture']","['erectile dysfunction', 'International Erectile Function Index-5 (IIEF-5) score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",103.0,0.144524,"In order to evaluate, the exact effect of acupuncture on the clinical efficacy of patients with Post-stroke Erectile dysfunction (PSED), this experiment uses randomized controlled experiments.
","[{'ForeName': 'Yanfeng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Urology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing.'}, {'ForeName': 'Xudong', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Graduate School of Beijing University of Chinese Medicine, Chaoyang.'}, {'ForeName': 'Ruijia', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Graduate School of Beijing University of Chinese Medicine, Chaoyang.'}, {'ForeName': 'Jisheng', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Graduate School of Beijing University of Chinese Medicine, Chaoyang.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Deng', 'Affiliation': 'Graduate School of Beijing University of Chinese Medicine, Chaoyang.'}, {'ForeName': 'Bowen', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Graduate School of Beijing University of Chinese Medicine, Chaoyang.'}, {'ForeName': 'Chongyang', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Graduate School of Beijing University of Chinese Medicine, Chaoyang.'}, {'ForeName': 'Haisong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Andrology.'}]",Medicine,['10.1097/MD.0000000000019718']
319,32282729,Randomized control trial of ultrasound-guided erector spinae block versus shoulder periarticular anesthetic infiltration for pain control after arthroscopic shoulder surgery: Study protocol clinical trial (SPIRIT compliant).,"INTRODUCTION


Moderate to severe postoperative pain and associated opioid use may interfere with patients' well-being and course of recovery. Regional anesthetic techniques provide an opportunity for opioid sparing and improved patient outcomes. A new regional technique called the erector spinae plane (ESP) block has the potential to provide effective analgesia after shoulder arthroscopy with minimal risks and decreased opioid consumption. Our primary objective is to determine whether, in patients who undergo arthroscopic shoulder surgery, a preoperative ESP block reduces pain scores as compared to periarticular infiltration at the end of surgery. Additionally, we will also examine other factors such as opioid consumption, sensory block, adverse events, patient satisfaction, and persistent pain.
METHODS


This is a 2-arm, single-center, parallel-design, double-blind randomized controlled trial of 60 patients undergoing arthroscopic shoulder surgery. Eligible patients will be recruited in the preoperative clinic. Using a computer-generated randomization, with a 1:1 allocation ratio, patients will be randomized to either the ESP or periarticular infiltration group. Patients will be followed in hospital in the postanesthesia care unit, at 24 hours, and at 1 month. The study with be analyzed as intention-to-treat.
DISCUSSION


This study will inform an evidence-based choice in recommending ESP block for shoulder arthroscopy, as well as providing safety data. The merits of the study include its double dummy blinding to minimize observer bias, and its assessment of patient important outcomes, including pain scores, opioid consumption, and patient satisfaction. This study will also help provide an estimate of the incidence of side effects and complications of the ESP block.
TRIAL REGISTRATION NUMBER


NCT03691922; Recruited Date of registration: October 2, 2018.",2020,A new regional technique called the erector spinae plane (ESP) block has the potential to provide effective analgesia after shoulder arthroscopy with minimal risks and decreased opioid consumption.,"['60 patients undergoing arthroscopic shoulder surgery', 'pain control after arthroscopic shoulder surgery', 'patients who undergo arthroscopic shoulder surgery, a', 'Eligible patients will be recruited in the preoperative clinic']","['ESP or periarticular infiltration group', 'preoperative ESP block', 'ultrasound-guided erector spinae block']","['pain scores', 'opioid consumption, sensory block, adverse events, patient satisfaction, and persistent pain', 'pain scores, opioid consumption, and patient satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0186321', 'cui_str': 'Operative procedure on shoulder'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0595695', 'cui_str': 'Periarticular route'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",60.0,0.417126,A new regional technique called the erector spinae plane (ESP) block has the potential to provide effective analgesia after shoulder arthroscopy with minimal risks and decreased opioid consumption.,"[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Czuczman', 'Affiliation': 'Department of Anesthesia.'}, {'ForeName': 'Harsha', 'Initials': 'H', 'LastName': 'Shanthanna', 'Affiliation': ""Department of Anesthesia, St Joseph's Health Care.""}, {'ForeName': 'Bashar', 'Initials': 'B', 'LastName': 'Alolabi', 'Affiliation': ""Department of Surgery, Joseph's Healthcare.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Moisiuk', 'Affiliation': ""Department of Anesthesia, St Joseph's Health Care.""}, {'ForeName': 'Turlough', 'Initials': 'T', 'LastName': ""O'Hare"", 'Affiliation': ""Department of Anesthesia, St Joseph's Health Care.""}, {'ForeName': 'Moin', 'Initials': 'M', 'LastName': 'Khan', 'Affiliation': ""Department of Surgery, Joseph's Healthcare.""}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Forero', 'Affiliation': ""Department of Anesthesia, St Joseph's Health Care.""}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Davis', 'Affiliation': ""Department of Anesthesia, St Joseph's Health Care.""}, {'ForeName': 'Jaydeep', 'Initials': 'J', 'LastName': 'Moro', 'Affiliation': ""Department of Surgery, Joseph's Healthcare.""}, {'ForeName': 'Thuva', 'Initials': 'T', 'LastName': 'Vanniyasingam', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}]",Medicine,['10.1097/MD.0000000000019721']
320,32282739,Application of multiple injections of contrast agent in head and neck CT arteriovenous angiography in children: Study protocol clinical trial (SPIRIT Compliant).,"OBJECTIVE


To investigate the application value of multiple injections of contrast agent in head and neck CT arteriovenous angiography in children.
METHODS


A total of 100 children aged 6 to 7 years who needed head and neck CT arteriovenous angiography were prospectively selected. They were randomly divided into a control group and a research group, with 50 children in each group. The same scanning parameters and reconstruction methods were used. The right median cubital vein was injected intravenously with the contrast agent Omnipaque (350 mg I/ml). For children in the control group, a bolus of undiluted contrast agent (dose was 2 ml/kg, upper limit was 50 ml) was injected 1 time. The arterial phase and vein phase of the head and neck vessels were scanned. For children in the research group, a contrast agent bolus diluted with saline to a concentration of 20% was first injected (dose was 1 ml/kg, upper limit was 25 ml), and then an undiluted contrast agent bolus (dose was 1 ml/kg, upper limit was 25 ml) was injected. Thresholds were used to trigger the scanning of the head and neck arterial phases. The CT image quality of the head and neck arteries and veins, radiation dose and contrast agent dose were compared between the 2 groups.
RESULTS


Subjective evaluation of CT image quality of arteries: there were 47 cases of 4 points and 3 cases of 3 points in the control group and 34 cases of 4 points and 16 cases of 3 points in the research group. Subjective evaluation of CT image quality of veins: there were 47 cases of 4 points and 3 cases of 3 points in the control group and 5 cases of 4 points, 42 cases of 3 points and 3 cases of 2 points in the research group. The CT value of brain arterial vessel enhancement was higher in the control group than the research group, and the difference was statistically significant (P < .05). The CT value of vein enhancement was higher in the control group than the research group, and the difference was statistically significant (P < .05). The X-ray dose in the research group was 51% lower than that in the control group; the contrast agent dose in the research group was 44% lower than that in the control group.
CONCLUSION


For the head and neck enhanced CT examination of children, the method of first bolus injection of 20% diluted contrast agent and later bolus injection of undiluted contrast agent can clearly demonstrate the head and neck arteries and veins one time, reducing the X-ray dose and contrast agent dose, which has clinical practical value in the enhanced CT examination of children with head and neck disease.",2020,"The CT value of vein enhancement was higher in the control group than the research group, and the difference was statistically significant (P < .05).","['head and neck CT arteriovenous angiography in children', '100 children aged 6 to 7 years who needed head and neck CT arteriovenous angiography were prospectively selected', 'children with head and neck disease']",[],"['Subjective evaluation of CT image quality of veins', 'CT value of vein enhancement', 'CT image quality of arteries', 'CT value of brain arterial vessel enhancement']","[{'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0450109', 'cui_str': 'Arteriovenous'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",[],"[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}]",100.0,0.0177129,"The CT value of vein enhancement was higher in the control group than the research group, and the difference was statistically significant (P < .05).","[{'ForeName': 'Shilong', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': 'Department of Radiology.'}, {'ForeName': 'Guanping', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'National Clinical Research Center for Child Health and Disorders.'}, {'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology.'}, {'ForeName': 'Xianfan', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Ministry of Education Key Laboratory of Child Development and Disorders.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Fan', 'Affiliation': 'China International Science and Technology Cooperation base of Child development and Critical Disorders.'}, {'ForeName': 'Daisong', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'He', 'Affiliation': 'Department of Radiology.'}]",Medicine,['10.1097/MD.0000000000019773']
321,32108029,A Randomized Controlled Trial of a 6-Month Low-Carbohydrate Intervention on Disease Progression in Men with Recurrent Prostate Cancer: Carbohydrate and Prostate Study 2 (CAPS2).,"PURPOSE


Both weight loss and low-carbohydrate diets (LCD) without weight loss prolong survival in prostate cancer models. Few human trials have tested weight loss or LCD on prostate cancer.
EXPERIMENTAL DESIGN


We conducted a multi-site randomized 6-month trial of LCD versus control on PSA doubling time (PSADT) in patients with prostate cancer with biochemical recurrence (BCR) after local treatment. Eligibility included body mass index (BMI) ≥ 24 kg/m 2  and PSADT 3 to 36 months. The LCD arm was instructed to eat [Formula: see text]20 g/carbs/day; the control arm instructed to avoid dietary changes. Primary outcome was PSADT. Secondary outcomes included weight, lipids, glucose metabolism, and diet.
RESULTS


Of 60 planned patients, the study stopped early after an interim analysis showed futility. Twenty-seven LCD and 18 control patients completed the study. At 6 months, although both arms consumed similar protein and fats, the LCD arm reduced carbohydrates intake (-117 vs. 8 g,  P  < 0.001) and lost weight (-12.1 vs. -0.50 kg,  P  < 0.001). The LCD arm reduced HDL, triglycerides, and HbA1c with no difference in total cholesterol or glucose. Mean PSADT was similar between LCD (21 months) and control (15 months,  P  = 0.316) arms. In a  post hoc  exploratory analysis accounting for prestudy PSADT, baseline PSA, primary treatment, and hemoconcentration, PSADT was significantly longer in LCD versus control (28 vs. 13 months,  P  = 0.021) arms. Adverse events were few, usually mild, and returned to baseline by 6 months.
CONCLUSIONS


Among BCR patients, LCD induced weight loss and metabolic benefits with acceptable safety without affecting PSADT, suggesting LCD does not adversely affect prostate cancer growth and is safe. Given exploratory findings of longer PSADT, larger studies testing LCD on disease progression are warranted.",2020,"Mean PSADT was similar between LCD (21 months) vs. control (15 months, p=0.316).","['PC patients with biochemical recurrence (BCR) after local treatment', 'men with recurrent prostate cancer', '27 LCD and 18 controls completed the study']","['low carbohydrate intervention', 'LCD', 'weight loss and low carbohydrate diets (LCD) without weight loss']","['weight, lipids, glucose metabolism, and diet', 'lost weight', 'Mean PSADT', 'protein and fats, LCD reduced carbohydrates intake', 'LCD reduced HDL, triglycerides, and HbA1c with no difference in total cholesterol or glucose', 'Adverse events', 'weight loss and metabolic benefits', 'PSA doubling time (PSADT', 'disease progression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0259836', 'cui_str': 'Diet, Carbohydrate-Restricted'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}]",,0.0777638,"Mean PSADT was similar between LCD (21 months) vs. control (15 months, p=0.316).","[{'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Freedland', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California. stephen.freedland@cshs.org.'}, {'ForeName': 'Jenifer', 'Initials': 'J', 'LastName': 'Allen', 'Affiliation': 'Duke Clinical and Translational Science Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Aubrey', 'Initials': 'A', 'LastName': 'Jarman', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Taofik', 'Initials': 'T', 'LastName': 'Oyekunle', 'Affiliation': 'Duke University Medical Center, Duke Cancer Institute, Durham, North Carolina.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Armstrong', 'Affiliation': 'Duke University Medical Center, Duke Cancer Institute, Durham, North Carolina.'}, {'ForeName': 'Judd W', 'Initials': 'JW', 'LastName': 'Moul', 'Affiliation': 'Duke University Medical Center, Duke Cancer Institute, Durham, North Carolina.'}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Sandler', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Posadas', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Levin', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Wiggins', 'Affiliation': 'Durham VA Medical Center, Durham, North Carolina.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Howard', 'Affiliation': 'Durham VA Medical Center, Durham, North Carolina.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Pao-Hwa', 'Initials': 'PH', 'LastName': 'Lin', 'Affiliation': 'Duke University School of Medicine, Durham, North Carolina.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-3873']
322,32108355,Recombinant human insulin-like growth factor-1 therapy for 6 months improves growth but not motor function in boys with Duchenne muscular dystrophy.,"INTRODUCTION


Recombinant human insulin-like growth factor-1 (rhIGF-1) is a growth factor and has anabolic effects on muscle. We investigated whether rhIGF-1 therapy: 1) improves or preserves muscle function; and 2) improves growth in boys with Duchenne muscular dystrophy (DMD).
METHODS


In this study we compared prepubescent, ambulatory, glucocorticoid-treated boys with DMD (n = 17) vs controls (glucocorticoid therapy only, n = 21) in a 6-month-long, prospective, randomized, controlled trial of subcutaneous rhIGF-1 therapy. The primary outcome was 6-minute walk distance (6MWD). Secondary outcomes included height velocity (HV), change in height standard deviation score (ΔHtSDS), motor function, cardiopulmonary function, body composition, insulin sensitivity, quality of life, and safety.
RESULTS


Change in 6MWD was similar between groups (rhIGF-1 vs controls [mean ± SD]: 3.4 ± 32.4 vs -5.1 ± 50.2 meters, P = .53). Treated subjects grew more than controls (HV: 6.5 ± 1.7 vs 3.3 ± 1.3 cm/year, P < .0001; 6-month ΔHtSDS: 0.25, P < .0001). Lean mass and insulin sensitivity increased in treated subjects.
DISCUSSION


In boys with DMD, 6 months of rhIGF-1 therapy did not change motor function, but it improved linear growth.",2020,"Treated subjects grew more than controls (HV: 6.5±1.7 vs. 3.3±1.3cm/year, p<0.0001; 6-month ∆HtSDS 0.25 SD, p<0.0001).","['prepubescent, ambulatory, glucocorticoid-treated boys with DMD (n=17) compared to controls (glucocorticoid therapy only, n=21', 'boys with Duchenne muscular dystrophy (DMD', 'boys with Duchenne Muscular Dystrophy']","['subcutaneous rhIGF-1 therapy', 'rhIGF-1 therapy', 'Recombinant human insulin-like growth factor-1 (rhIGF-1) therapy']","['6-minute walk distance (6MWD', 'linear growth', 'height velocity (HV), change in height SD (∆HtSDS), motor function, cardiopulmonary function, body composition, insulin sensitivity, quality of life, and safety', 'Lean mass and insulin sensitivity', '6MWD']","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0744425', 'cui_str': 'Glucocorticoid therapy'}, {'cui': 'C0013264', 'cui_str': 'Cardiomyopathy, Dilated, X-Linked'}]","[{'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0904505', 'cui_str': 'mecasermin'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0034380'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",,0.150267,"Treated subjects grew more than controls (HV: 6.5±1.7 vs. 3.3±1.3cm/year, p<0.0001; 6-month ∆HtSDS 0.25 SD, p<0.0001).","[{'ForeName': 'Meilan M', 'Initials': 'MM', 'LastName': 'Rutter', 'Affiliation': ""Division of Endocrinology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}, {'ForeName': 'Brenda L', 'Initials': 'BL', 'LastName': 'Wong', 'Affiliation': 'Department of Pediatrics and Neurology, University of Massachusetts Medical School, Worcester, Massachusetts, USA.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Collins', 'Affiliation': 'Mercy Clinic Pediatric Neurology, Springfield, Missouri, USA.'}, {'ForeName': 'Hemant', 'Initials': 'H', 'LastName': 'Sawnani', 'Affiliation': ""Division of Pulmonary Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Taylor', 'Affiliation': ""The Heart Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Horn', 'Affiliation': ""Division of Pediatric Neurology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}, {'ForeName': 'Philippe F', 'Initials': 'PF', 'LastName': 'Backeljauw', 'Affiliation': ""Division of Endocrinology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}]",Muscle & nerve,['10.1002/mus.26846']
323,32311926,Impact of healthy diet and physical activity on metabolic health in men and women: Study Protocol Clinical Trial (SPIRIT Compliant).,"INTRODUCTION


Healthy dietary patterns and physical activity (PA) represent important lifestyle behaviors with considerable potential to influence on age-related metabolic health. Yet, data on the combined effects of these lifestyle behaviors on metabolic health including low-grade systemic inflammation in aging populations remain scarce. Therefore, this protocol describes a randomized controlled trial aiming to examine the impacts of healthy dietary patterns alone or combined with PA on metabolic health in middle-aged and older men and women.
MATERIAL AND METHODS


The ORUDIET study is a 3-arm randomized controlled 16-week trial: Healthy Diet (HD), Healthy diet plus PA (HD-PA), and control (CON). The trial is open label, randomized with allocation concealment, parallel groups with passive controls. Participants without overt disease aged between 55 and 70 years, with BMI below 35, a current intake of a maximum of 1 serving of fruit and vegetable per day, and noncompliance to PA guidelines are eligible for inclusion. Participants in HD are instructed to increase fruit and vegetable intake to 5 servings per day (equivalent to 500 g). Participants in HD-PA receive the same dietary intervention as the HD and are additionally instructed to engage in moderate-to-vigorous physical activities for at least 150 minutes per week. The primary study outcomes are changes in metabolic and inflammatory health biomarkers. Secondary outcomes are changes in body composition and perceived health.
ETHICS AND DISSEMINATION


The study protocol has been approved by the ethical review board in Uppsala, Sweden. The results will be published in peer-reviewed journals and disseminated in national and international conferences.
TRIAL REGISTRATION NUMBER


NCT04062682 Pre-results.",2020,"The ORUDIET study is a 3-arm randomized controlled 16-week trial: Healthy Diet (HD), Healthy diet plus PA (HD-PA), and control (CON).","['middle-aged and older men and women', 'Participants without overt disease aged between 55 and 70 years, with BMI below 35, a current intake of a maximum of 1 serving of fruit and vegetable per day, and noncompliance to PA guidelines are eligible for inclusion', 'men and women']","['healthy diet and physical activity', 'Healthy dietary patterns and physical activity (PA', 'Healthy Diet (HD), Healthy diet plus PA (HD-PA), and control (CON', 'healthy dietary patterns alone or combined with PA']","['metabolic health', 'changes in body composition and perceived health', 'changes in metabolic and inflammatory health biomarkers']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0376405', 'cui_str': 'Noncompliance with treatment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.0740695,"The ORUDIET study is a 3-arm randomized controlled 16-week trial: Healthy Diet (HD), Healthy diet plus PA (HD-PA), and control (CON).","[{'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Bergens', 'Affiliation': 'School of Health Sciences, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Jort', 'Initials': 'J', 'LastName': 'Veen', 'Affiliation': ''}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Montiel-Rojas', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Edholm', 'Affiliation': ''}, {'ForeName': 'Fawzi', 'Initials': 'F', 'LastName': 'Kadi', 'Affiliation': ''}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Nilsson', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000019584']
324,32311936,Effects of breastfeeding education based on the self-efficacy theory on women with gestational diabetes mellitus: A CONSORT-compliant randomized controlled trial.,"BACKGROUND


Women with gestational diabetes mellitus (GDM) face big challenges of breastfeeding. In order to improve breastfeeding self-efficacy and breastfeeding rate of them, we formulated perinatal individualized interventions based on self-efficacy theory and conducted a randomized controlled trial to verify the effectiveness.
METHODS


We conducted a randomized controlled trial. The perinatal individualized interventions based on the self-efficacy theory including 4 phases were led by the International Board Certified Lactation Consultant (IBCLC). Women allocated to the control group received usual care for lactation support during the antenatal and postnatal period. Data collection occurred at admission, discharge, 6 weeks postpartum, 4 months postpartum, and 6 months postpartum.
RESULTS


We enrolled 226 women with GDM, 113 in the intervention group and 113 in the control group. The scores of breastfeeding self-efficacy in the intervention group were significantly higher than those in the control group at discharge, at 6 weeks, 4 months, and 6 months postpartum (P < .05). We found higher rates of exclusive and any breastfeeding in the intervention group at discharge (Exclusive: 25.2% vs 13.5%, P < .05; Any: 94.4% vs 89.4%, P > .05), at 6 weeks postpartum (Exclusive: 75.5% vs 62.5%, P < .05; Any: 100.0% vs 96.2%, P > .05), at 4 months postpartum (Exclusive: 68.9% vs 43.3%, P < .05; Any: 94.3% vs 83.7%, P < .05) and at 6 months postpartum (Exclusive: 55.8% vs 36.9%, P < .05; Any: 88.5% vs 64.1%, P < .05).
CONCLUSION


Perinatal individualized breastfeeding education based on the self-efficacy theory had positive effects on breastfeeding self-efficacy and breastfeeding rate of women with GDM.",2020,"The scores of breastfeeding self-efficacy in the intervention group were significantly higher than those in the control group at discharge, at 6 weeks, 4 months, and 6 months postpartum (P < .05).","['women with gestational diabetes mellitus', 'women with GDM', 'Women with gestational diabetes mellitus (GDM', '226 women with GDM, 113 in the intervention group and 113 in the control group']","['breastfeeding education', 'control group received usual care for lactation support']","['breastfeeding self-efficacy and breastfeeding rate', 'scores of breastfeeding self-efficacy', 'rates of exclusive and any breastfeeding']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C4546716', 'cui_str': 'Indium-113'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0418914', 'cui_str': 'Breastfeeding education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",226.0,0.0791,"The scores of breastfeeding self-efficacy in the intervention group were significantly higher than those in the control group at discharge, at 6 weeks, 4 months, and 6 months postpartum (P < .05).","[{'ForeName': 'Huaxuan', 'Initials': 'H', 'LastName': 'You', 'Affiliation': 'Department of Obstetrics and Gynecology.'}, {'ForeName': 'Anjiang', 'Initials': 'A', 'LastName': 'Lei', 'Affiliation': 'Department of Obstetrics and Gynecology.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xiang', 'Affiliation': 'Department of Obstetrics and Gynecology.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynecology.'}, {'ForeName': 'Biru', 'Initials': 'B', 'LastName': 'Luo', 'Affiliation': 'Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University).'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University).'}]",Medicine,['10.1097/MD.0000000000019643']
325,32311940,The efficacy of transcranial alternating current stimulation for treating post-stroke depression: Study Protocol Clinical Trial (SPIRIT Compliant).,"BACKGROUND


The treatment of post-stroke depression (PSD) with anti-depressant drugs is partly practical. Transcranial alternating current stimulation (tACS) offers the potential for a novel treatment modality for adult patients with PSD. In this study, we will assess the efficacy and safety of tACS for treating PSD and explore its effect on gamma and beta-oscillations involving in emotional regulation.
METHODS


The prospective study is an 8-week, double-blind, randomized, placebo-controlled trial. Seventy eligible participants with mild to moderate PSD aged between 18 years and 70 years will be recruited and randomly assigned to either active tACS intervention group or sham group. Daily 40-minute, 77.5-Hz, 15-mA sessions of active or sham tACS targeting the forehead and both mastoid areas on weekdays for 4 consecutive weeks (week 4), and an additional 4-week observational period (week 8) will be followed up. The primary outcome is the proportion of participants having an improvement at week 8 according to the Hamilton Depression Rating Scale 17-Item (HAMD-17) score, including the proportion of participants having a decrease of ≥ 50% in HAMD-17 score or clinical recovery (HAMD-17 score ≤ 7). Secondary outcomes include neurological function, independence level, activities of daily living, disease severity, anxiety, and cognitive function. The exploratory outcomes are gamma and beta-oscillations assessed at baseline, week 4, and week 8. Data will be analyzed by logistical regression analyses and mixed-effects models.
DISCUSSION


The study will be the first randomized controlled trial to evaluate the efficacy and safety of tACS at a 77.5-Hz frequency and 15-mA current in reducing depressive severity in patients with PSD. The results of the study will present a base for future studies on the tACS in PSD and its possible mechanism.
TRIAL REGISTRATION NUMBER


NCT03903068, pre-results.",2020,Transcranial alternating current stimulation (tACS) offers the potential for a novel treatment modality for adult patients with PSD.,"['patients with PSD', 'Seventy eligible participants with mild to moderate PSD aged between 18 years and 70 years', 'adult patients with PSD']","['transcranial alternating current stimulation', 'Daily 40-minute, 77.5-Hz, 15-mA sessions of active or sham tACS', 'placebo', 'Transcranial alternating current stimulation (tACS', 'tACS', 'active tACS intervention group or sham group']","['efficacy and safety', 'depressive severity', 'proportion of participants having an improvement at week 8 according to the Hamilton Depression Rating Scale 17-Item (HAMD-17) score, including the proportion of participants having a decrease of ≥ 50% in HAMD-17 score or clinical recovery (HAMD-17 score ≤ 7', 'neurological function, independence level, activities of daily living, disease severity, anxiety, and cognitive function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2938940', 'cui_str': 'Post stroke depression'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0559741', 'cui_str': 'Item score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",70.0,0.229424,Transcranial alternating current stimulation (tACS) offers the potential for a novel treatment modality for adult patients with PSD.,"[{'ForeName': 'Hongxing', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University.'}, {'ForeName': 'Wenrui', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University.'}, {'ForeName': 'Wenfeng', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Puren Hospital.'}, {'ForeName': 'Zu', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University.'}, {'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Peng', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Xue', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University.'}, {'ForeName': 'Haixia', 'Initials': 'H', 'LastName': 'Leng', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University.'}, {'ForeName': 'Weijun', 'Initials': 'W', 'LastName': 'Ding', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Dong', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University.'}, {'ForeName': 'Xiaoqin', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University.'}, {'ForeName': 'Yunyan', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University.'}, {'ForeName': 'Changbiao', 'Initials': 'C', 'LastName': 'Chu', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University.'}, {'ForeName': 'Sufang', 'Initials': 'S', 'LastName': 'Xue', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University.'}, {'ForeName': 'Liyuan', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Yao', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Ding', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University.'}, {'ForeName': 'Shuqin', 'Initials': 'S', 'LastName': 'Zhan', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University.'}, {'ForeName': 'Baoquan', 'Initials': 'B', 'LastName': 'Min', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University.'}, {'ForeName': 'Chunqiu', 'Initials': 'C', 'LastName': 'Fan', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University.'}, {'ForeName': 'Aihong', 'Initials': 'A', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University.'}, {'ForeName': 'Zhichao', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yin', 'Affiliation': 'Medical Research & Biometrics Centre, National Centre for Cardiovascular Diseases Cardiovascular.'}, {'ForeName': 'Qingfeng', 'Initials': 'Q', 'LastName': 'Ma', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University.'}, {'ForeName': 'Andrius', 'Initials': 'A', 'LastName': 'Baskys', 'Affiliation': 'Andrius Baskys, Graduate College of Biomedical Sciences, Western University of Health Sciences, Pomona, CA.'}, {'ForeName': 'Ricardo E', 'Initials': 'RE', 'LastName': 'Jorge', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Haiqing', 'Initials': 'H', 'LastName': 'Song', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University.'}]",Medicine,['10.1097/MD.0000000000019671']
326,32139381,Efficacy and Safety of Liraglutide 3.0 mg in Individuals With Overweight or Obesity and Type 2 Diabetes Treated With Basal Insulin: The SCALE Insulin Randomized Controlled Trial.,"OBJECTIVE


Most individuals with type 2 diabetes also have obesity, and treatment with some diabetes medications, including insulin, can cause further weight gain. No approved chronic weight management medications have been prospectively investigated in individuals with overweight or obesity and insulin-treated type 2 diabetes. The primary objective of this study was to assess the effect of liraglutide 3.0 mg versus placebo on weight loss in this population.
RESEARCH DESIGN AND METHODS


Satiety and Clinical Adiposity-Liraglutide Evidence (SCALE) Insulin was a 56-week, randomized, double-blind, placebo-controlled, multinational, multicenter trial in individuals with overweight or obesity and type 2 diabetes treated with basal insulin and ≤2 oral antidiabetic drugs.
RESULTS


Individuals were randomized to liraglutide 3.0 mg ( n  = 198) or placebo ( n  = 198), combined with intensive behavioral therapy (IBT). At 56 weeks, mean weight change was -5.8% for liraglutide 3.0 mg versus -1.5% with placebo (estimated treatment difference -4.3% [95% CI -5.5; -3.2];  P  < 0.0001). With liraglutide 3.0 mg, 51.8% of individuals achieved ≥5% weight loss versus 24.0% with placebo (odds ratio 3.41 [95% CI 2.19; 5.31];  P  < 0.0001). Liraglutide 3.0 mg was associated with significantly greater reductions in mean HbA 1c  and mean daytime glucose values and less need for insulin versus placebo, despite a treat-to-glycemic-target protocol. More hypoglycemic events were observed with placebo than liraglutide 3.0 mg. No new safety or tolerability issues were observed.
CONCLUSIONS


In individuals with overweight or obesity and insulin-treated type 2 diabetes, liraglutide 3.0 mg as an adjunct to IBT was superior to placebo regarding weight loss and improved glycemic control despite lower doses of basal insulin and without increases in hypoglycemic events.",2020,"Liraglutide 3.0 mg was associated with significantly greater reductions in mean HbA 1c , mean daytime glucose values, and less need for insulin versus placebo, despite a treat-to-glycemic target protocol.","['individuals with overweight or obesity and insulin-treated type 2 diabetes', 'individuals with overweight or obesity and type 2 diabetes treated with basal insulin and less than or equal to two oral antidiabetic drugs', 'individuals with type 2 diabetes', 'Individuals With Overweight or Obesity and Type']","['Liraglutide', 'Basal Insulin', 'placebo', 'intensive behavioral therapy (IBT', 'liraglutide']","['weight loss', 'mean weight change', 'hypoglycemic events', 'weight loss and improved glycemic control', '≥5% weight loss', 'Efficacy and Safety', 'mean HbA 1c , mean daytime glucose values']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetics'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.311179,"Liraglutide 3.0 mg was associated with significantly greater reductions in mean HbA 1c , mean daytime glucose values, and less need for insulin versus placebo, despite a treat-to-glycemic target protocol.","[{'ForeName': 'W Timothy', 'Initials': 'WT', 'LastName': 'Garvey', 'Affiliation': 'Department of Nutrition Sciences, The University of Alabama at Birmingham and the Birmingham VA Medical Center, Birmingham, AL garveyt@uab.edu.'}, {'ForeName': 'Andreas L', 'Initials': 'AL', 'LastName': 'Birkenfeld', 'Affiliation': 'Department of Diabetology, Endocrinology, and Nephrology, Eberhard Karls University Tübingen, Tübingen, Germany.'}, {'ForeName': 'Dror', 'Initials': 'D', 'LastName': 'Dicker', 'Affiliation': 'Internal Medicine D, Hasharon Hospital, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Geltrude', 'Initials': 'G', 'LastName': 'Mingrone', 'Affiliation': ""Division of Diabetes and Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, London, U.K.""}, {'ForeName': 'Sue D', 'Initials': 'SD', 'LastName': 'Pedersen', 'Affiliation': 'C-ENDO Diabetes and Endocrinology Clinic, Calgary, Alberta, Canada.'}, {'ForeName': 'Altynai', 'Initials': 'A', 'LastName': 'Satylganova', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Dorthe', 'Initials': 'D', 'LastName': 'Skovgaard', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Sugimoto', 'Affiliation': 'Cedar Crosse Research Center, Chicago, IL.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Jensen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Diabetes Unit, Department of Internal Medicine, Hadassah Hebrew University Hospital, Jerusalem, Israel.'}]",Diabetes care,['10.2337/dc19-1745']
327,32165444,Intrahepatic Fat and Postprandial Glycemia Increase After Consumption of a Diet Enriched in Saturated Fat Compared With Free Sugars.,"OBJECTIVE


Debate continues regarding the influence of dietary fats and sugars on the risk of developing metabolic diseases, including insulin resistance and nonalcoholic fatty liver disease (NAFLD). We investigated the effect of two eucaloric diets, one enriched with saturated fat (SFA) and the other enriched with free sugars (SUGAR), on intrahepatic triacylglycerol (IHTAG) content, hepatic de novo lipogenesis (DNL), and whole-body postprandial metabolism in overweight males.
RESEARCH DESIGN AND METHODS


Sixteen overweight males were randomized to consume the SFA or SUGAR diet for 4 weeks before consuming the alternate diet after a 7-week washout period. The metabolic effects of the respective diets on IHTAG content, hepatic DNL, and whole-body metabolism were investigated using imaging techniques and metabolic substrates labeled with stable-isotope tracers.
RESULTS


Consumption of the SFA diet significantly increased IHTAG by mean ± SEM 39.0 ± 10.0%, while after the SUGAR diet IHTAG was virtually unchanged. Consumption of the SFA diet induced an exaggerated postprandial glucose and insulin response to a standardized test meal compared with SUGAR. Although whole-body fat oxidation, lipolysis, and DNL were similar following the two diets, consumption of the SUGAR diet resulted in significant ( P  < 0.05) decreases in plasma total, HDL, and non-HDL cholesterol and fasting β-hydroxybutyrate plasma concentrations.
CONCLUSIONS


Consumption of an SFA diet had a potent effect, increasing IHTAG together with exaggerating postprandial glycemia. The SUGAR diet did not influence IHTAG and induced minor metabolic changes. Our findings indicate that a diet enriched in SFA is more harmful to metabolic health than a diet enriched in free sugars.",2020,Consumption of the SFA diet induced an exaggerated postprandial glucose and insulin response to a standardized test meal compared with SUGAR.,"['Sixteen overweight males', 'overweight males']","['SFA or SUGAR diet', 'eucaloric diets, one enriched with saturated fat (SFA) and the other enriched with free sugars (SUGAR']","['plasma total, HDL, and non-HDL cholesterol and fasting β-hydroxybutyrate plasma concentrations', 'IHTAG content, hepatic DNL, and whole-body metabolism', 'exaggerated postprandial glucose and insulin response', 'Intrahepatic Fat and Postprandial Glycemia Increase', 'intrahepatic triacylglycerol (IHTAG) content, hepatic de novo lipogenesis (DNL']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0597423', 'cui_str': 'Fatty Acids, Saturated'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C1563744', 'cui_str': 'Lipogenesis'}]",16.0,0.0155907,Consumption of the SFA diet induced an exaggerated postprandial glucose and insulin response to a standardized test meal compared with SUGAR.,"[{'ForeName': 'Siôn A', 'Initials': 'SA', 'LastName': 'Parry', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Churchill Hospital, Oxford, U.K.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Rosqvist', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Churchill Hospital, Oxford, U.K.'}, {'ForeName': 'Ferenc E', 'Initials': 'FE', 'LastName': 'Mozes', 'Affiliation': 'Oxford Centre for Clinical Magnetic Resonance Research, University of Oxford, John Radcliffe Hospital, Oxford, U.K.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Cornfield', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Churchill Hospital, Oxford, U.K.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hutchinson', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Churchill Hospital, Oxford, U.K.'}, {'ForeName': 'Marie-Eve', 'Initials': 'ME', 'LastName': 'Piche', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Churchill Hospital, Oxford, U.K.'}, {'ForeName': 'Andreas J', 'Initials': 'AJ', 'LastName': 'Hülsmeier', 'Affiliation': 'Institute for Clinical Chemistry, University Hospital Zurich and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Hornemann', 'Affiliation': 'Institute for Clinical Chemistry, University Hospital Zurich and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Dyson', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Churchill Hospital, Oxford, U.K.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Hodson', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Churchill Hospital, Oxford, U.K. leanne.hodson@ocdem.ox.ac.uk.'}]",Diabetes care,['10.2337/dc19-2331']
328,30706519,Does having a similar disability matter for match outcomes?: A randomized study of matching mentors and mentees by visual impairment.,"Mentoring is modestly effective for youth with a chronic illness or physical disability; however, program effectiveness may be enhanced when mentors and mentees are matched on shared interests and experiences. To test this hypothesis, mentees were randomly assigned to having a mentor with or without visual impairment (VI). Results showed that mentors without VI were younger and more likely to work or be educated in a helping profession and less likely to have a fixed mindset and extremely high positive expectations than mentors with VI. The main analyses on match outcomes showed that mentors with VI had significantly fewer and shorter match meetings, had a weaker relationship with their mentees, and were more likely to end their match prematurely. Mentor age, helping profession background, and fixed mindset were confounds in several analyses and reduced the significance of the relationship between VI group and match meeting quantity. The only relationship that remained significant controlling for covariates showed that matches including a mentor with VI were significantly more likely to end in premature closure than matches including a mentor without VI. Implications of the findings for future research and program practices related to matching were discussed.",2019,"The main analyses on match outcomes showed that mentors with VI had significantly fewer and shorter match meetings, had a weaker relationship with their mentees, and were more likely to end their match prematurely.",['youth with a chronic illness or physical disability'],[],[],"[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap (finding)'}]",[],[],,0.0630223,"The main analyses on match outcomes showed that mentors with VI had significantly fewer and shorter match meetings, had a weaker relationship with their mentees, and were more likely to end their match prematurely.","[{'ForeName': 'Eline C M', 'Initials': 'ECM', 'LastName': 'Heppe', 'Affiliation': 'Vrije Universiteit Amsterdam.'}, {'ForeName': 'Janis B', 'Initials': 'JB', 'LastName': 'Kupersmidt', 'Affiliation': 'Innovation Research & Training.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Kef', 'Affiliation': 'Vrije Universiteit Amsterdam.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Schuengel', 'Affiliation': 'Vrije Universiteit Amsterdam.'}]",Journal of community psychology,['10.1002/jcop.22116']
329,32234355,Patient Education and Engagement Through Multimedia: A Prospective Pilot Study on Health Literacy in Patients with Cerebral Aneurysms.,"BACKGROUND


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


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


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


Overall, in the present prospective study, the use of a multimedia-based educational intervention resulted in an upward trend in knowledge without a statistically significant difference in patient satisfaction scores compared with the control patients. To better measure the effectiveness of multimedia-based patient education interventions, future studies should account for the patients' baseline education level, preexisting educational resources available to study patients, socioeconomic factors, and emotional state.",2020,No statistical difference was detected in patient satisfaction scores between the intervention and control groups.,"['one-year period in 2018', 'Patients with Cerebral Aneurysms', '52 brain aneurysm patients (newly diagnosed or follow-up) presenting for their neurosurgery outpatient clinic visit', 'patients with a newly diagnosed complex disease']","['multimedia educational intervention', 'Health Literacy', 'educational intervention', 'multimedia-based patient education interventions']","['patient knowledge scores', 'patient health literacy and satisfaction', 'knowledge gain', 'patient satisfaction scores']","[{'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155730', 'cui_str': 'Cerebral aneurysm, nonruptured'}, {'cui': 'C0751003', 'cui_str': 'Brain Aneurysm'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}]",26.0,0.0575532,No statistical difference was detected in patient satisfaction scores between the intervention and control groups.,"[{'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Agarwal', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, USA. Electronic address: agarwaln@upmc.edu.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Funahashi', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, USA.'}, {'ForeName': 'Tavis', 'Initials': 'T', 'LastName': 'Taylor', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, USA.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Jorge', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, USA.'}, {'ForeName': 'Rafey', 'Initials': 'R', 'LastName': 'Feroze', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Hansberry', 'Affiliation': 'Department of Radiology, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Gross', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, USA.'}, {'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Jankowitz', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Friedlander', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, USA.'}]",World neurosurgery,['10.1016/j.wneu.2020.03.099']
330,32282720,"Effectiveness and safety of electroacupuncture and its cotreatment with electronic moxibustion in the treatment of patients with moderate benign prostatic hyperplasia using alpha blocker: Study protocol for an assessor-blinded, randomized controlled clinical trial.","BACKGROUND


Benign prostatic hyperplasia (BPH) is a medical condition that affects the quality of life by causing lower urinary tract symptoms (LUTS) in 40% to 70% of men aged ≥60 years. Medication treatment is primarily recommended for patients with BPH if their symptom score based on the International Prostate Symptom score (IPSS) is above the moderate level. However, electroacupuncture (EA) and electronic moxibustion (EM), one of the most recent complementary and alternative treatments, are suggested as adjuvant treatments in the improvement of LUTS caused by BPH with respect to the limitations of medication treatments, such as side effects or no improvement in LUTS despite treatment. Therefore, this study aimed to evaluate the effectiveness and safety of EA and its cotreatment with EM for the improvement of LUTS in patients diagnosed with BPH using an alpha blocker but with moderate symptoms on the basis of IPSS.
METHODS/DESIGN


This protocol is a 2-arm parallel-design, randomized, controlled assessor-blinded clinical trial. Seventy-eight patients diagnosed with BPH are randomized to one of the following groups: [EA and its cotreatment with EM + alpha blocker group] and [alpha blocker group]. [EA and its cotreatment with EM + alpha blocker group] continues to use the previously prescribed alpha blocker and visits the study institution 3 times a week for 6 weeks to receive the cotreatment of EA and EM. [Alpha blocker group] continues to use the previously prescribed alpha blocker for 6 weeks. To evaluate the effectiveness of the EA and its cotreatment with EM, the followings are measured: total score of the IPSS, IPSS quality of life assessment, EuroQol-Five dimension, maximum and average urinary flow rate (Qmax and Qave), and prostate size at the baseline, 3rd, 6th, and 12th weeks. The primary effectiveness endpoint measures the average change in the total score of the IPSS at the 6th week. Side effects are recorded at each visit.
DISCUSSION


The results of this study are expected to provide useful information on the effectiveness and safety of the EA and its cotreatment with EM for patients with BPH with regard to the improvements in LUTS.
TRIAL REGISTRATION


Clinical Research Information Service of Republic of Korea (CRIS-KCT0004411), October 31, 2019.",2020,Medication treatment is primarily recommended for patients with BPH if their symptom score based on the International Prostate Symptom score (IPSS) is above the moderate level.,"['patients diagnosed with BPH using an alpha blocker but with moderate symptoms on the basis of IPSS', 'Benign prostatic hyperplasia (BPH', 'Seventy-eight patients diagnosed with BPH', 'patients with moderate benign prostatic hyperplasia using alpha blocker', 'patients with BPH if their symptom score based on the International Prostate Symptom score (IPSS', 'patients with BPH']","['electronic moxibustion', 'EA', 'electroacupuncture (EA) and electronic moxibustion (EM', 'electroacupuncture', 'EM + alpha blocker']","['Effectiveness and safety', 'Side effects', 'average change in the total score of the IPSS', 'total score of the IPSS, IPSS quality of life assessment, EuroQol-Five dimension, maximum and average urinary flow rate (Qmax and Qave), and prostate size']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0001641', 'cui_str': 'Alpha adrenergic receptor antagonist'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0001641', 'cui_str': 'Alpha adrenergic receptor antagonist'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0429785', 'cui_str': 'Average urinary flow rate'}, {'cui': 'C0426731', 'cui_str': 'Prostate size'}]",78.0,0.0679168,Medication treatment is primarily recommended for patients with BPH if their symptom score based on the International Prostate Symptom score (IPSS) is above the moderate level.,"[{'ForeName': 'Hyo Bin', 'Initials': 'HB', 'LastName': 'Kim', 'Affiliation': 'Department of Acupuncture and Moxibustion Medicine, College of Korean Medicine, Daejeon University, Daejeon.'}, {'ForeName': 'Young Il', 'Initials': 'YI', 'LastName': 'Kim', 'Affiliation': 'Department of Acupuncture and Moxibustion Medicine, College of Korean Medicine, Daejeon University, Daejeon.'}, {'ForeName': 'Ju Hyun', 'Initials': 'JH', 'LastName': 'Jeon', 'Affiliation': 'Department of Acupuncture and Moxibustion Medicine, College of Korean Medicine, Daejeon University, Daejeon.'}, {'ForeName': 'Eunseok', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'Department of Acupuncture and Moxibustion Medicine, College of Korean Medicine, Daejeon University, Daejeon.'}, {'ForeName': 'Jin Youp', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Korean Medicine, Graduate School, Kyung Hee University, Seoul.'}, {'ForeName': 'Ojin', 'Initials': 'O', 'LastName': 'Kwon', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine.'}, {'ForeName': 'Young Eun', 'Initials': 'YE', 'LastName': 'Choi', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine.'}, {'ForeName': 'Changsop', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine.'}, {'ForeName': 'Chang-Hyun', 'Initials': 'CH', 'LastName': 'Han', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine.'}]",Medicine,['10.1097/MD.0000000000019678']
331,32302064,Relative bioavailability and pharmacokinetic comparison of calcium glucoheptonate with calcium carbonate.,"Adequate calcium intake is important for the prevention of bone loss and osteoporosis. For some populations such as those of Southeast Asia where calcium intake is very low, supplements represent a suitable dietary source of calcium. The objective of this study was to compare the relative oral bioavailability of calcium from calcium glucoheptonate, a highly soluble calcium salt containing 8.2% of elemental calcium, to that of calcium carbonate. A single-dose, randomized-sequence, open-label, two-period crossover study, with a 7-day washout period, was conducted in 24 Indonesian healthy adult volunteers. After a 12-hour (overnight) fast, subjects received either two oral ampoules of 250 mg/10 mL of calcium glucoheptonate each or one effervescent tablet of calcium carbonate containing 500 mg of elemental calcium. The relative oral bioavailability of calcium from calcium glucoheptonate as compared to calcium carbonate was 92% within 6 hours and 89% within 12 hours after study drug administration. The 90% confidence intervals for the mean test/reference ratios of the maximum plasma concentration and the area under the concentration-time curve at 12 hours post-administration were 77.09%-120.31% and 60.58%-122.30%, respectively. Five subjects experienced a total of eight adverse events which were all mild and transient; no serious adverse events or deaths were reported. These results indicate that calcium glucoheptonate is associated with a high relative bioavailability of calcium compared to calcium carbonate, and is well-tolerated. Calcium glucoheptonate might thus be a potential choice for calcium supplementation in Southeast Asian populations.",2020,Five subjects experienced a total of eight adverse events which were all mild and transient; no serious adverse events or deaths were reported.,"['24 Indonesian healthy adult volunteers', 'Southeast Asian populations']","['calcium glucoheptonate with calcium carbonate', 'calcium glucoheptonate', 'calcium carbonate containing 500\xa0mg of elemental calcium', 'Calcium glucoheptonate', 'calcium from calcium glucoheptonate', 'calcium carbonate']","['mean test/reference ratios of the maximum plasma concentration and the area under the concentration-time curve', 'total of eight adverse events', 'relative oral bioavailability', 'serious adverse events or deaths']","[{'cui': 'C0021248', 'cui_str': 'Indonesian language'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0238697', 'cui_str': 'South East Asian'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0108111', 'cui_str': 'Calcium gluceptate'}, {'cui': 'C0006681', 'cui_str': 'Calcium Carbonate'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",24.0,0.0152834,Five subjects experienced a total of eight adverse events which were all mild and transient; no serious adverse events or deaths were reported.,"[{'ForeName': 'Mss', 'Initials': 'M', 'LastName': 'Wiria', 'Affiliation': 'Department of Pharmacology and Therapeutics, Faculty of Medicine, University of Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Hung Manh', 'Initials': 'HM', 'LastName': 'Tran', 'Affiliation': 'Faculty of Pharmacy, University of Medicine and Pharmacy, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Phuc H B', 'Initials': 'PHB', 'LastName': 'Nguyen', 'Affiliation': 'Consumer HealthCare, Sanofi, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Valencia', 'Affiliation': 'PT Pharma Metric Labs, Jakarta, Indonesia.'}, {'ForeName': 'Surajit', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Consumer HealthCare, Sanofi, Singapore, Singapore.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Pouteau', 'Affiliation': 'Consumer HealthCare, Sanofi, Gentilly, France.'}]",Pharmacology research & perspectives,['10.1002/prp2.589']
332,32144165,Increase in Endogenous Glucose Production With SGLT2 Inhibition Is Unchanged by Renal Denervation and Correlates Strongly With the Increase in Urinary Glucose Excretion.,"OBJECTIVE


Sodium-glucose cotransporter 2 (SGLT2) inhibition causes an increase in endogenous glucose production (EGP). However, the mechanisms are unclear. We studied the effect of SGLT2 inhibitors on EGP in subjects with type 2 diabetes (T2D) and without diabetes (non-DM) in kidney transplant recipients with renal denervation.
RESEARCH DESIGN AND METHODS


Fourteen subjects who received a renal transplant (six with T2D [A1C 7.2 ± 0.1%] and eight non-DM [A1C 5.6 ± 0.1%) underwent measurement of EGP with [3- 3 H]glucose infusion following dapagliflozin (DAPA) 10 mg or placebo. Plasma glucose, insulin, C-peptide, glucagon, and titrated glucose-specific activity were measured.
RESULTS


Following placebo in T2D, fasting plasma glucose (FPG) (143 ± 14 to 124 ± 10 mg/dL;  P  = 0.02) and fasting plasma insulin (12 ± 2 to 10 ± 1.1 μU/mL;  P  < 0.05) decreased; plasma glucagon was unchanged, and EGP declined. After DAPA in T2D, FPG (143 ± 15 to 112 ± 9 mg/dL;  P  = 0.01) and fasting plasma insulin (14 ± 3 to 11 ± 2 μU/mL;  P  = 0.02) decreased, and plasma glucagon increased (all  P  < 0.05 vs. placebo). EGP was unchanged from baseline (2.21 ± 0.19 vs. 1.96 ± 0.14 mg/kg/min) in T2D ( P  < 0.001 vs. placebo). In non-DM following DAPA, FPG and fasting plasma insulin decreased, and plasma glucagon was unchanged. EGP was unchanged from baseline (1.85 ± 0.10 to 1.78 ± 0.10 mg/kg/min) after DAPA, whereas EGP declined significantly with placebo. When the increase in EGP production following DAPA versus placebo was plotted against the difference in urinary glucose excretion (UGE) for all patients, a strong correlation ( r  = 0.824;  P  < 0.001) was observed.
CONCLUSIONS


Renal denervation in patients who received a kidney transplant failed to block the DAPA-mediated stimulation of EGP in both individuals with T2D and non-DM subjects. The DAPA-stimulated rise in EGP is strongly related to the increase in UGE, blunting the decline in FPG.",2020,EGP was unchanged from baseline (2.21 ± 0.19 vs. 1.96 ± 0.14 mg/kg/min) in T2D ( P  < 0.001 vs. placebo).,"['subjects with type 2 diabetes (T2D) and without diabetes (non-DM) in kidney transplant recipients with renal denervation', 'Fourteen subjects who received a renal transplant (six with T2D [A1C 7.2 ± 0.1%] and eight non-DM [A1C 5.6 ± 0.1%) underwent measurement of']","['SGLT2 inhibitors', 'placebo', 'SGLT2', 'EGP with [3- 3 H]glucose infusion following dapagliflozin (DAPA) 10 mg or placebo', 'Sodium-glucose cotransporter 2']","['Urinary Glucose Excretion', ' plasma glucagon', 'Plasma glucose, insulin, C-peptide, glucagon, and titrated glucose-specific activity', 'urinary glucose excretion (UGE', 'plasma glucagon', 'endogenous glucose production (EGP', 'EGP', 'T2D, fasting plasma glucose (FPG', 'EGP production', 'Endogenous Glucose Production', 'fasting plasma insulin', 'DAPA, FPG and fasting plasma insulin decreased, and plasma glucagon']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C1321798', 'cui_str': 'Muscle denervation'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C4517857', 'cui_str': '7.2 (qualifier value)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C4517794', 'cui_str': '5.6 (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]","[{'cui': 'C3273807', 'cui_str': 'Gliflozins'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C1278023', 'cui_str': 'Plasma glucagon measurement'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0033268'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}]",14.0,0.0856011,EGP was unchanged from baseline (2.21 ± 0.19 vs. 1.96 ± 0.14 mg/kg/min) in T2D ( P  < 0.001 vs. placebo).,"[{'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Solis-Herrera', 'Affiliation': 'Division of Diabetes, The University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Daniele', 'Affiliation': 'Division of Diabetes, The University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Alatrach', 'Affiliation': 'Division of Diabetes, The University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Agyin', 'Affiliation': 'Division of Diabetes, The University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Triplitt', 'Affiliation': 'Division of Diabetes, The University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Adams', 'Affiliation': 'Division of Diabetes, The University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Rupal', 'Initials': 'R', 'LastName': 'Patel', 'Affiliation': 'Division of Diabetes, The University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Gastaldelli', 'Affiliation': 'Division of Diabetes, The University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Henri', 'Initials': 'H', 'LastName': 'Honka', 'Affiliation': 'Division of Diabetes, The University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Division of Diabetes, The University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Abdul-Ghani', 'Affiliation': 'Division of Diabetes, The University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Cersosimo', 'Affiliation': 'Division of Diabetes, The University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Stephano', 'Initials': 'S', 'LastName': 'Del Prato', 'Affiliation': 'Section of Diabetes and Metabolic Disease, Department of Clinical and Experimental Medicine, University of Pisa and Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'DeFronzo', 'Affiliation': 'Division of Diabetes, The University of Texas Health Science Center at San Antonio, San Antonio, TX albarado@uthscsa.edu.'}]",Diabetes care,['10.2337/dc19-2177']
333,32144166,Dalcetrapib Reduces Risk of New-Onset Diabetes in Patients With Coronary Heart Disease.,"OBJECTIVE


Incident type 2 diabetes is common among patients with recent acute coronary syndrome and is associated with an adverse prognosis. Some data suggest that cholesteryl ester transfer protein (CETP) inhibitors reduce incident type 2 diabetes. We compared the effect of treatment with the CETP inhibitor dalcetrapib or placebo on incident diabetes in patients with recent acute coronary syndrome.
RESEARCH DESIGN AND METHODS


In the dal-OUTCOMES trial, 15,871 patients were randomly assigned to treatment with dalcetrapib 600 mg daily or placebo, beginning 4-12 weeks after an acute coronary syndrome. Absence of diabetes at baseline was based on medical history, no use of antihyperglycemic medication, and hemoglobin A 1c  and serum glucose levels below diagnostic thresholds. Among these patients, incident diabetes after randomization was defined by any diabetes-related adverse event, new use of antihyperglycemic medication, hemoglobin A 1c  ≥6.5%, or a combination of at least two measurements of serum glucose ≥7.0 mmol/L (fasting) or ≥11.1 mmol/L (random).
RESULTS


At baseline, 10,645 patients (67% of the trial cohort) did not have diabetes. During a median follow-up of 30 months, incident diabetes was identified in 403 of 5,326 patients (7.6%) assigned to dalcetrapib and in 516 of 5,319 (9.7%) assigned to placebo, corresponding to absolute risk reduction of 2.1%, hazard ratio of 0.77 (95% CI 0.68-0.88;  P  < 0.001), and a need to treat 40 patients for 3 years to prevent 1 incident case of diabetes. Considering only those with prediabetes at baseline, the number needed to treat for 3 years to prevent 1 incident case of diabetes was 25. Dalcetrapib also decreased the number of patients who progressed from normoglycemia to prediabetes and increased the number who regressed from diabetes to no diabetes.
CONCLUSIONS


In patients with a recent acute coronary syndrome, incident diabetes is common and is reduced substantially by treatment with dalcetrapib.",2020,"Dalcetrapib also decreased the number of patients who progressed from normoglycemia to prediabetes and increased the number who regressed from diabetes to no diabetes.
","['10,645 patients (67% of the trial cohort) did not have diabetes', 'Patients With Coronary Heart Disease', '15,871 patients', 'patients with recent acute coronary syndrome']","['dalcetrapib', 'Dalcetrapib', 'CETP inhibitor dalcetrapib or placebo', 'placebo', 'cholesteryl ester transfer protein (CETP) inhibitors']",['incident diabetes'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}]","[{'cui': 'C2713495', 'cui_str': 'S-(2-((1-(2-ethylbutyl)cyclohexane)carbonylamino)phenyl) 2-methylpropanethioate'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0055538', 'cui_str': 'Cholesterol Ester Transport Protein, CETP'}]",[],15871.0,0.109939,"Dalcetrapib also decreased the number of patients who progressed from normoglycemia to prediabetes and increased the number who regressed from diabetes to no diabetes.
","[{'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Schwartz', 'Affiliation': 'Cardiology Section, Veterans Affairs Medical Center, and University of Colorado School of Medicine, Aurora, CO gregory.schwartz@va.gov.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Christie M', 'Initials': 'CM', 'LastName': 'Ballantyne', 'Affiliation': 'Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Barter', 'Affiliation': 'University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Donald M', 'Initials': 'DM', 'LastName': 'Black', 'Affiliation': 'DalCor Pharmaceuticals, Zug, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kallend', 'Affiliation': 'The Medicines Company, Zurich, Switzerland.'}, {'ForeName': 'Fouzia', 'Initials': 'F', 'LastName': 'Laghrissi-Thode', 'Affiliation': 'DalCor Pharmaceuticals, Zug, Switzerland.'}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Leitersdorf', 'Affiliation': 'Hadassah Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, Scotland, U.K.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Nicholls', 'Affiliation': 'Monash Cardiovascular Research Centre, Monash University, Melbourne, Australia.'}, {'ForeName': 'Anders G', 'Initials': 'AG', 'LastName': 'Olsson', 'Affiliation': 'Linköping University, Linköping, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Preiss', 'Affiliation': 'Medical Research Council Population Health Research Unit, Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, U.K.'}, {'ForeName': 'Prediman K', 'Initials': 'PK', 'LastName': 'Shah', 'Affiliation': 'Cedars-Sinai Heart Institute, Los Angeles, CA.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Tardif', 'Affiliation': 'Montreal Heart Institute, Université de Montréal, Montreal, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kittelson', 'Affiliation': 'University of Colorado School of Public Health, Aurora, CO.'}]",Diabetes care,['10.2337/dc19-2204']
334,32314290,The effect of Zataria multiflora on inflammatory cytokine and respiratory symptoms in veterans exposed to sulfur mustard.,"The effect of Zataria multiflora (Z. multiflora) on serum cytokine, chemokines, and respiratory symptoms in the veterans exposed to sulfur mustard (SM) more than two decades (27-30 years) ago was conducted in 2018. Thirty-four patients were randomly assigned to the placebo group (P, mean age (54.40 ± 5.51)) and two treated groups with Z. multiflora extract 5 and 10 mg/kg/day (Z5 and 10; mean age, 58.50 ± 3.60 and 55.18 ± 4.11, respectively). Serum levels of tumor necrosis factor (TNF-α), monocyte chemotactic protein 1 (MCP-1), vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), forced expiratory volume-one second (FEV 1 ), and respiratory symptoms including chest wheeze (CW), night wheeze (NW), night cough (NC), and cough and wheeze during exercise (ECW) were assessed at the baseline (phase 0), 1 and 2 months after starting treatment (phase I and II, respectively). The value of FEV 1  was significantly increased in Z10 in phase I and II compared with that in phase 0 (p < 0.01 for both) and in Z5 in phase II compared with phase I and 0 (p < 0.001for both). All respiratory symptoms significantly decreased in Z5 and 10 in phase I and II compared with those in phase 0 (p < 0.05 to p < 0.001). Serum levels of TNF-α and VEGF were decreased in Z5 and 10 in phase I and II compared with those in phase 0 (p < 0.05 to p < 0.001). Serum levels of MCP-1 and EGF were decreased in Z10 in phase I and II compared with those in phase 0 (p < 0.05 to p < 0.001). The percent change of respiratory symptoms, serum levels of cytokines during the treatment period, was significantly improved in the treated groups compared with that in the placebo group. Two months' of treatment with Z. multiflora improved cytokine levels, respiratory symptom, and FEV 1  values in SM-exposed patients.",2020,"Serum levels of tumor necrosis factor (TNF-α), monocyte chemotactic protein 1 (MCP-1), vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), forced expiratory volume-one second (FEV 1 ), and respiratory symptoms including chest wheeze (CW), night wheeze (NW), night cough (NC), and cough and wheeze during exercise (ECW) were assessed at the baseline (phase 0), 1 and 2 months after starting treatment (phase I and II, respectively).","['veterans exposed to sulfur mustard (SM) more than two decades (27-30\xa0years) ago was conducted in 2018', 'Thirty-four patients', 'veterans exposed to sulfur mustard']","['Zataria multiflora', 'Zataria multiflora (Z. multiflora', 'placebo']","['value of FEV 1', 'cytokine levels, respiratory symptom, and FEV 1  values', 'respiratory symptoms, serum levels of cytokines', 'inflammatory cytokine and respiratory symptoms', 'serum cytokine, chemokines, and respiratory symptoms', 'All respiratory symptoms', 'Serum levels of TNF-α and VEGF', 'Serum levels of MCP-1 and EGF', 'Serum levels of tumor necrosis factor (TNF-α), monocyte chemotactic protein 1 (MCP-1), vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), forced expiratory volume-one second (FEV 1 ), and respiratory symptoms including chest wheeze (CW), night wheeze (NW), night cough (NC), and cough and wheeze during exercise (ECW']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0026874', 'cui_str': 'Mustard gas'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0003023', 'cui_str': 'Angola'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0242275', 'cui_str': 'Epidermal Growth Factor'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}]",34.0,0.0320334,"Serum levels of tumor necrosis factor (TNF-α), monocyte chemotactic protein 1 (MCP-1), vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), forced expiratory volume-one second (FEV 1 ), and respiratory symptoms including chest wheeze (CW), night wheeze (NW), night cough (NC), and cough and wheeze during exercise (ECW) were assessed at the baseline (phase 0), 1 and 2 months after starting treatment (phase I and II, respectively).","[{'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Khazdair', 'Affiliation': 'Cardiovascular Diseases Research Center, Birjand University of Medical Sciences, Birjand, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Rezaeetalab', 'Affiliation': 'COPD Research Center, Department of Internal Medicine, Imam-Reza Hospital, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Houshang', 'Initials': 'H', 'LastName': 'Rafatpanah', 'Affiliation': 'Department of Immunology, Immunology Research Center, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Boskabady', 'Affiliation': 'Department of Physiology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, 9177948564, Iran. boskabadymh@mums.ac.ir.'}]",Environmental science and pollution research international,['10.1007/s11356-020-08855-5']
335,32102112,Biologics for chronic rhinosinusitis.,"BACKGROUND


This living systematic review is one of several Cochrane Reviews evaluating the medical management of patients with chronic rhinosinusitis. Chronic rhinosinusitis is common. It is characterised by inflammation of the nasal and sinus linings, nasal blockage, rhinorrhoea, facial pressure/pain and loss of sense of smell. It occurs with or without nasal polyps.   'Biologics' are medicinal products produced by a biological process. Monoclonal antibodies are one type, already evaluated in related inflammatory conditions (e.g. asthma and atopic dermatitis).
OBJECTIVES


To assess the effects of biologics for the treatment of chronic rhinosinusitis.
SEARCH METHODS


The Cochrane ENT Information Specialist searched the Cochrane ENT Register; CENTRAL (2019, Issue 9); Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 16 September 2019.
SELECTION CRITERIA


Randomised controlled trials (RCTs) with at least three months follow-up comparing biologics (currently, monoclonal antibodies) against placebo/no treatment in patients with chronic rhinosinusitis.
DATA COLLECTION AND ANALYSIS


We used standard Cochrane methodological procedures. Our primary outcomes were disease-specific health-related quality of life (HRQL), disease severity and serious adverse events (SAEs). The secondary outcomes were avoidance of surgery, extent of disease (measured by endoscopic or computerised tomography (CT) score), generic HRQL and adverse events (nasopharyngitis, including sore throat). We used GRADE to assess the certainty of the evidence for each outcome.
MAIN RESULTS


We included eight RCTs. Of 986 adult participants, 984 had severe chronic rhinosinusitis with nasal polyps; 43% to 100% of participants also had asthma. Three biologics, with different targets, were evaluated: dupilumab, mepolizumab and omalizumab. All the studies were sponsored or supported by industry. Anti-IL-4Rα mAb (dupilumab) versusplacebo/no treatment (all receiving intranasal steroids) Three studies (784 participants) evaluated dupilumab. Disease-specific HRQL was measured with the SNOT-22 (score 0 to 110; minimal clinically important difference (MCID) 8.9 points). At 24 weeks, the SNOT-22 score was 19.61 points lower (better) in participants receiving dupilumab (mean difference (MD) -19.61, 95% confidence interval (CI) -22.54 to -16.69; 3 studies; 784 participants; high certainty). Symptom severity measured on a 0- to 10-point visual analogue scale (VAS) was 3.00 lower in those receiving dupilumab (95% CI -3.47 to -2.53; 3 studies; 784 participants; moderate certainty). The risk of serious adverse events may be lower in the dupilumab group (risk ratio (RR) 0.45, 95% CI 0.28 to 0.75; 3 studies; 782 participants; low certainty).  The number of participants requiring nasal polyp surgery (actual or planned) during the treatment period is probably lower in those receiving dupilumab (RR 0.17, 95% CI 0.05 to 0.52; 2 studies; 725 participants; moderate certainty). Change in the extent of disease using the Lund Mackay computerised tomography (CT) score (0 to 24, higher = worse) was -7.00 (95% CI -9.61 to -4.39; 3 studies; 784 participants; high certainty), a large effect favouring the dupilumab group.  The EQ-5D visual analogue scale (0 to 100, higher = better; MCID 8 points) was used to measure change in generic quality of life. The mean difference favouring dupilumab was 8.59 (95% CI 5.31 to 11.86; 2 studies; 706 participants; moderate certainty). There may be little or no difference in the risk of nasopharyngitis (RR 0.95, 95% CI 0.72 to 1.25; 3 studies; 783 participants; low certainty). Anti-IL-5 mAb (mepolizumab) versusplacebo/no treatment (all receiving intranasal steroids) Two studies (137 participants) evaluated mepolizumab. Disease-specific HRQL measured with the SNOT-22 at 25 weeks was 13.26 points lower (better) in participants receiving mepolizumab (95% CI -22.08 to -4.44; 1 study; 105 participants; low certainty; MCID 8.9).  It is very uncertain whether there is a difference in s ymptom severity: on a 0- to 10-point VAS symptom severity was -2.03 lower in those receiving mepolizumab (95% CI -3.65 to -0.41; 1 study; 72 participants; very low certainty). It is very uncertain if there is difference in the risk of serious adverse events (RR 1.57, 95% CI 0.07 to 35.46; 2 studies; 135 participants, very low certainty). It is very uncertain whether or not the overall risk that patients still need surgery at trial end is lower in the mepolizumab group (RR 0.78, 95% CI 0.64 to 0.94; 2 studies; 135 participants; very low certainty). It is very uncertain whether mepolizumab reduces the extent of disease as measured by endoscopic nasal polyps score (scale range 0 to 8). The mean difference was 1.23 points lower in the mepolizumab group (MD -1.23, 95% -1.79 to -0.68; 2 studies; 137 participants; very low certainty). The difference in generic quality of life (EQ-5D) was 5.68 (95% CI -1.18 to 12.54; 1 study; 105 participants; low certainty), favouring the mepolizumab group. This difference is smaller than the MCID of 8 points. There may be little or no difference in the risk of nasopharyngitis (RR 0.73, 95% 0.36 to 1.47; 2 studies; 135 participants; low certainty). Anti-IgE mAb (omalizumab) versus placebo/no treatment (all receiving intranasal steroids) Three very small studies (65 participants) evaluated omalizumab. We are very uncertain about the effect of omalizumab on disease-specific HRQL, severe adverse events, extent of disease (CT scan scores), generic HRQL and adverse effects.
AUTHORS' CONCLUSIONS


In adults with severe chronic rhinosinusitis and nasal polyps, using regular topical nasal steroids, dupilumab improves disease-specific HRQL compared to placebo, and reduces the extent of the disease as measured on a CT scan. It probably also improves symptoms and generic HRQL and there is no evidence of an increased risk of serious adverse events. It may reduce the need for further surgery. There may be little or no difference in the risk of nasopharyngitis. In similar patients, mepolizumab may improve both disease-specific and generic HRQL. It is uncertain whether it reduces the need for surgery or improves nasal polyp scores. There may be little or no difference in the risk of nasopharyngitis. It is uncertain if there is a difference in symptom severity and the risk of serious adverse events. We are uncertain about the effects of omalizumab.",2020,The difference in generic quality of life (EQ-5D) was 5.68,"['986 adult participants, 984 had severe chronic rhinosinusitis with nasal polyps; 43% to 100% of\xa0participants also had asthma', 'adults with severe chronic rhinosinusitis and nasal polyps', 'chronic rhinosinusitis', 'to -4.39; 3 studies; 784 participants; high certainty),\xa0a large effect favouring the dupilumab group', 'patients with chronic rhinosinusitis', '3.47\xa0to -2.53; 3 studies; 784 participants; moderate\xa0certainty']","['omalizumab', 'Anti-IL-4Rα mAb (dupilumab', 'Anti-IL-5 mAb (mepolizumab', 'placebo', 'versusplacebo/no treatment (all receiving intranasal steroids', 'Anti-IgE mAb (omalizumab)\xa0versus placebo/no treatment (all receiving\xa0intranasal steroids', 'biologics']","['SNOT-22 score', 'Lund Mackay computerised tomography (CT) score', 'avoidance of surgery, extent of disease (measured by endoscopic or computerised tomography (CT) score), generic HRQL and adverse events (nasopharyngitis, including sore throat', 'generic quality of life', 'Disease-specific HRQL', '10-point VAS\xa0symptom severity', 'risk\xa0of nasopharyngitis', 'endoscopic nasal polyps score', 'nasal polyp scores', 'number of participants requiring nasal polyp\xa0surgery (actual or planned', 'EQ-5D visual analogue scale', 'generic quality of life (EQ-5D', 'risk of nasopharyngitis', 'disease-specific HRQL, severe adverse events, extent of disease (CT scan scores), generic HRQL and adverse effects', 'Symptom severity measured on\xa0a 0- to 10-point visual analogue scale (VAS', 'disease-specific HRQL', 'disease-specific and generic HRQL', 'disease-specific health-related quality of life (HRQL), disease severity and serious adverse events (SAEs']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4524092', 'cui_str': 'Chronic rhinosinusitis with nasal polyps'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0149516', 'cui_str': 'Chronic sinusitis (disorder)'}, {'cui': 'C0027430', 'cui_str': 'Nasal Polyps'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439543', 'cui_str': 'Certainties (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]","[{'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C0021759', 'cui_str': 'Interleukin-5'}, {'cui': 'C0969324', 'cui_str': 'mepolizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0051978', 'cui_str': 'anti-IgE antibodies'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0449279', 'cui_str': 'Extent of disease (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0242429', 'cui_str': 'Sore Throat'}, {'cui': 'C0034380'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0027430', 'cui_str': 'Nasal Polyps'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",986.0,0.240152,The difference in generic quality of life (EQ-5D) was 5.68,"[{'ForeName': 'Lee-Yee', 'Initials': 'LY', 'LastName': 'Chong', 'Affiliation': 'UK Cochrane Centre, Oxford, UK.'}, {'ForeName': 'Patorn', 'Initials': 'P', 'LastName': 'Piromchai', 'Affiliation': 'Faculty of Medicine, Khon Kaen University, Department of Otorhinolaryngology, Khon Kaen, Thailand.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Sharp', 'Affiliation': 'National Institute for Health and Care Excellence, Level 1A, City Tower, Piccadilly Plaza, Manchester, UK, M1 4BT.'}, {'ForeName': 'Kornkiat', 'Initials': 'K', 'LastName': 'Snidvongs', 'Affiliation': 'Chulalongkorn University, Department of Otolaryngology, Faculty of Medicine, Bangkok, Thailand.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Philpott', 'Affiliation': 'Norwich Medical School, University of East Anglia, Department of Medicine, Norwich, UK, NR4 7TJ.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Hopkins', 'Affiliation': ""Guy's Hospital, ENT Department, Gerat Maze Pond, London, UK, SE1 9RT.""}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Burton', 'Affiliation': 'Cochrane UK, Summertown Pavilion, 18 - 24 Middle Way, Oxford, UK, OX2 7LG.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD013513.pub2']
336,30197099,"Letter Regarding ""The Prostacyclin Analogue Iloprost as an Early Predictor of Successful Revascularization in Diabetic Patients Affected by Critical Limb Ischemia and Foot Ulcers"".","PURPOSE


The aim of this study is to evaluate the role of Iloprost as an early predictor of successful revascularization in patients affected by ischemic diabetic foot ulcers (DFUs).
METHODS


Consecutive patients with ischemic DFUs with persistent low TcPO2 (<30mmHg) one day after a technical successful Percutaneous Transluminal Angioplasty (PTA) have been included. All patients underwent Iloprost infusion and TcPO2 has been recorded at days 3, 14 and 30. According to the TcPO2 reported at day 3, patients were divided into two groups: group A (patients with TcPO2 ≥30mmHg) and group B (patients with TcPO2 <30mmHg). Baseline TcPO2 values at days 3, 14 and 30 after Iloprost infusion and needing of re-intervention (re-PTA) have been evaluated.
RESULTS


Twenty-five patients have been included, 12/25 (48%) in Group A and 13/25 (52%) in Group B. There were no significant differences at the baseline and one day after PTA between the two groups while TcPO2 values recorded in Group A at days 3, 14 and 30 after Iloprost infusion were significant higher in comparison to the Group B (χ = 0.005). The rate of re-PTA were respectively 33,3% (Group A) and 53,8% (Group B) (p = 0.03).
CONCLUSIONS


Iloprost may be an early predictor of successful revascularization in patients affected by critical limb ischemia (CLI) and DFUs.",2019,"There were no significant differences at the baseline and one day after PTA between the two groups while TcPO2 values recorded in Group A at days 3, 14 and 30 after Iloprost infusion were significant higher in comparison to the Group B (χ = 0.005).","['patients affected by ischemic diabetic foot ulcers (DFUs', 'diabetic patients affected by critical limb ischemia and foot ulcers', 'Consecutive patients with ischemic DFUs with persistent low TcPO2 (<30mmHg) one day after a technical successful']","['prostacyclin analogue Iloprost', 'Iloprost infusion and TcPO2', 'Iloprost', 'Percutaneous Transluminal Angioplasty (PTA']","['rate of re-PTA', 'TcPO2 values', 'Baseline TcPO2 values']","[{'cui': 'C0522476', 'cui_str': 'Patient affected (contextual qualifier) (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer (disorder)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C1142264', 'cui_str': 'Critical limb ischemia'}, {'cui': 'C0085119', 'cui_str': 'Foot Ulcer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]","[{'cui': 'C0205911', 'cui_str': 'Prostaglandins I'}, {'cui': 'C0079594', 'cui_str': 'Iloprost'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C2936666', 'cui_str': 'Percutaneous Transluminal Angioplasty'}, {'cui': 'C0015522', 'cui_str': 'Factor Eleven'}]","[{'cui': 'C0015522', 'cui_str': 'Factor Eleven'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0323337,"There were no significant differences at the baseline and one day after PTA between the two groups while TcPO2 values recorded in Group A at days 3, 14 and 30 after Iloprost infusion were significant higher in comparison to the Group B (χ = 0.005).","[{'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Izzo', 'Affiliation': 'Department of Systems Medicine, University of Tor Vergata, Viale Oxford 81, 00133 Rome, Italy. Electronic address: valentina_izzo@virgilio.it.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Meloni', 'Affiliation': 'Department of Systems Medicine, University of Tor Vergata, Viale Oxford 81, 00133 Rome, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Giurato', 'Affiliation': 'Department of Systems Medicine, University of Tor Vergata, Viale Oxford 81, 00133 Rome, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Uccioli', 'Affiliation': 'Department of Systems Medicine, University of Tor Vergata, Viale Oxford 81, 00133 Rome, Italy.'}]",Cardiovascular revascularization medicine : including molecular interventions,['10.1016/j.carrev.2018.08.021']
337,31122493,"Safety and efficacy of co-careldopa as an add-on therapy to occupational and physical therapy in patients after stroke (DARS): a randomised, double-blind, placebo-controlled trial.","BACKGROUND


Dopamine is a key modulator of striatal function and learning and might improve motor recovery after stroke. Previous small trials of dopamine agonists after stroke provide equivocal evidence of effectiveness on improving motor recovery. We aimed to assess the safety and efficacy of co-careldopa plus routine occupational and physical therapy during early rehabilitation after stroke.
METHODS


This double-blind, multicentre, randomised controlled trial of co-careldopa versus placebo in addition to routine NHS occupational and physical therapy was done at 51 UK NHS acute inpatient stroke rehabilitation services. We recruited patients with new or recurrent clinically diagnosed ischaemic or haemorrhagic (excluding subarachnoid haemorrhage) stroke 5-42 days before randomisation, who were unable to walk 10 m or more, had a score of less than 7 points on the Rivermead Mobility Index, were expected to need rehabilitation, and were able to access rehabilitation after discharge from hospital. Participants were assigned (1:1) using stratified random blocks to receive 6 weeks of oral co-careldopa or matched placebo in addition to routine NHS physiotherapy and occupational therapy. The initial two doses of co-careldopa were 62·5 mg (50 mg of levodopa and 12·5 mg of carbidopa) and the remaining doses were 125 mg (100 mg of levodopa and 25 mg of carbidopa). Participants were required to take a single oral tablet 45-60 min before physiotherapy or occupational therapy session. The primary outcome was ability to walk independently, defined as a Rivermead Mobility Index score of 7 or more, at 8 weeks. Primary and safety analyses were done in the intention-to-treat population. The trial is registered on the ISRCTN registry, number ISRCTN99643613.
FINDINGS


Between May 30, 2011, and March 28, 2014, of 1574 patients found eligible, 593 (mean age 68·5 years) were randomly assigned to either the co-careldopa group (n=308) or to the placebo group (n=285), on an average 18 days after stroke onset. Primary outcome data were available for all 593 patients. We found no evidence that the ability to walk independently improved with co-careldopa (125 [41%] of 308 patients) compared with placebo (127 [45%] of 285 patients; odds ratio 0·78 [95% CI 0·53-1·15]) at 8 weeks. Mortality at 12 months did not differ between the two groups (22 [7%] vs 17 [6%]). Serious adverse events were largely similar between groups. Vomiting during therapy sessions, after taking the study drug, was the most frequent adverse event and was more frequent in the co-careldopa group than the placebo group (19 [6·2%] vs 9 [3·2%]).
INTERPRETATION


Co-careldopa in addition to routine occupational and physical therapy does not seem to improve walking after stroke. Further research might identify subgroups of patients with stroke who could benefit from dopaminergic therapy at different doses or times after stroke with more intensive motor therapy.
FUNDING


Medical Research Council.",2019,Mortality at 12 months did not differ between the two groups (22 [7%] vs 17 [6%]).,"['51 UK NHS acute inpatient stroke rehabilitation services', 'patients after stroke (DARS', 'Between May 30, 2011, and March 28, 2014, of 1574 patients found eligible, 593 (mean age 68·5 years', 'patients with new or recurrent clinically diagnosed ischaemic or haemorrhagic (excluding subarachnoid haemorrhage) stroke 5-42 days before randomisation, who were unable to walk 10 m or more, had a score of less than 7 points on the Rivermead Mobility Index, were expected to need rehabilitation, and were able to access rehabilitation after discharge from hospital']","['oral co-careldopa or matched placebo in addition to routine NHS physiotherapy and occupational therapy', 'placebo', 'single oral tablet 45-60 min before physiotherapy or occupational therapy session', 'co-careldopa', 'routine NHS occupational and physical therapy', 'co-careldopa versus placebo', 'co-careldopa plus routine occupational and physical therapy', 'levodopa and 25 mg of carbidopa', 'levodopa and 12·5 mg of carbidopa']","['Mortality', 'safety and efficacy', 'ability to walk independently improved with co-careldopa', 'ability to walk independently, defined as a Rivermead Mobility Index score', 'Vomiting', 'Serious adverse events', 'Safety and efficacy']","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0204097', 'cui_str': 'Stroke Rehabilitation'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0038525', 'cui_str': 'SAH (Subarachnoid Hemorrhage)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0560046', 'cui_str': 'Unable to walk (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital (finding)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0993159', 'cui_str': 'Oral Tablet'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0521127', 'cui_str': 'Occupational (qualifier value)'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0006982', 'cui_str': 'Carbidopa'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0559964', 'cui_str': 'Ambulation ability'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.5157,Mortality at 12 months did not differ between the two groups (22 [7%] vs 17 [6%]).,"[{'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Ford', 'Affiliation': 'Oxford University Hospitals NHS Foundation Trust, University of Oxford, Oxford, UK. Electronic address: gary.ford@ouh.nhs.uk.'}, {'ForeName': 'Bipin B', 'Initials': 'BB', 'LastName': 'Bhakta', 'Affiliation': 'The Academic Department of Rehabilitation Medicine, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Cozens', 'Affiliation': 'NHS Grampian, Aberdeen, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Hartley', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Holloway', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Meads', 'Affiliation': 'Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Pearn', 'Affiliation': 'The Academic Department of Rehabilitation Medicine, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Ruddock', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Sackley', 'Affiliation': ""School of Population and Environmental Sciences, Faculty of Life Science and Medicine, King's College London, London, UK.""}, {'ForeName': 'Eirini-Christina', 'Initials': 'EC', 'LastName': 'Saloniki', 'Affiliation': 'Centre for Health Services Studies and Personal Social Services Research Unit, University of Kent, Canterbury, UK.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Santorelli', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Marion F', 'Initials': 'MF', 'LastName': 'Walker', 'Affiliation': 'Rehabilitation and Ageing, Queens Medical Centre, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Farrin', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30147-4']
338,31421635,Maintenance of antidepressant and antisuicidal effects by D-cycloserine among patients with treatment-resistant depression who responded to low-dose ketamine infusion: a double-blind randomized placebo-control study.,"Increasing evidence supports a rapid antidepressant and antisuicidal effect of a single subanesthetic dose of ketamine infusion for treatment-resistant depression (TRD). Maintaining the initial clinical response after ketamine infusion in TRD is a crucial next-step challenge. D-cycloserine (DCS), a partial agonist of the glycine co-agonist of the N-methyl-D-aspartate (NMDA) glutamate receptor, is potentially effective as a depression augmentation treatment. However, whether DCS maintains the antidepressant and antisuicidal effects of ketamine infusion remains unknown. In all, 32 patients with TRD (17 with major depression and 15 with bipolar depression) who responded to ketamine infusion with an average 17-item Hamilton Depression Rating Scale (HAMD) score of 9.47 ± 4.11 at baseline were randomly divided to 6-week DCS treatment (250 mg for 2 days, 500 mg for 2 days, 750 mg for 3 days, and 1000 mg for 5 weeks) and placebo groups. Depression symptoms were rated at timepoints of dose titration and weekly. During the 6-week treatment, the total scores of HAMD did not differ between the DCS and placebo groups. The results remained consistent when stratified by disorder. A mixed model analysis indicated that the DCS group exhibited lower scores of HAMD item 3 (suicide) compared with the placebo group throughout the follow-up period (p = 0.01). A superior maintenance of the antisuicidal effect of ketamine was observed in the DCS group than in the placebo group. DCS may be therapeutically beneficial for patients with TRD who responded to ketamine infusion but have a residual suicidal risk.",2019,A superior maintenance of the antisuicidal effect of ketamine was observed in the DCS group than in the placebo group.,"['32 patients with TRD (17 with major depression and 15 with bipolar depression', 'infusion with an average 17-item Hamilton Depression Rating Scale (HAMD) score of 9.47\u2009±\u20094.11 at baseline', 'patients with treatment-resistant depression who responded to low-dose ketamine infusion', 'patients with TRD']","['DCS treatment', 'placebo', 'DCS', 'ketamine', 'D-cycloserine (DCS', 'D-cycloserine']","['total scores of HAMD', 'Depression symptoms', 'HAMD item 3 (suicide']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0005587', 'cui_str': 'Depression, Bipolar'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}]",,0.143272,A superior maintenance of the antisuicidal effect of ketamine was observed in the DCS group than in the placebo group.,"[{'ForeName': 'Mu-Hong', 'Initials': 'MH', 'LastName': 'Chen', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chih-Ming', 'Initials': 'CM', 'LastName': 'Cheng', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Wei-Chen', 'Initials': 'WC', 'LastName': 'Lin', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Cheng-Ta', 'Initials': 'CT', 'LastName': 'Li', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chen-Jee', 'Initials': 'CJ', 'LastName': 'Hong', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Pei-Chi', 'Initials': 'PC', 'LastName': 'Tu', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Ya-Mei', 'Initials': 'YM', 'LastName': 'Bai', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shih-Jen', 'Initials': 'SJ', 'LastName': 'Tsai', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA. john.krystal@yale.edu.'}, {'ForeName': 'Tung-Ping', 'Initials': 'TP', 'LastName': 'Su', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan. tomsu0402@gmail.com.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0480-y']
339,31426118,[Therapy Options for Infants with Congenital Cytomegalovirus Infection - Implications for Setting Up Neonatal Screening Programs].,"INTRODUCTION


The number of diseases covered by universal neonatal screening in Germany has risen steadily from 1 (phenylketonuria) in 1968 to 17 (with hearing impairment and congenital hip dysplasia) in 2018. Treatment, however, of disorders diagnosed by screening may harm children, as failed neuroblastoma screening has shown. There are several pilot studies to detect congenital cytomegalovirus (CMV) infection but no consensus as to the treatment of the infants identified.
METHODOLOGY


Systematic search for studies investigating therapy of congenital CMV infection, using PubMed and the WHO International Clinical Trials Registry Platform (ICTRP).
RESULTS


We found only one controlled trial that randomized infants with symptomatic congenital CMV infection (involving the central nervous system) to treatment (intravenous ganciclovir for 6 weeks) or no treatment. Treatment was associated with significantly less hearing deterioration. A second trial comparing 6 weeks vs. 6 months of treatment with valganciclovir, an oral prodrug of ganciclovir, found no benefit for hearing but modestly improved developmental outcomes associated with 6 months of treatment. In contrast, an open-label registry reported benefits for infants with congenital CMV infection and isolated hearing who received valganciclovir for 12 months, with hearing improvement in 2/3 of cases after a median follow-up of 4½ years.
CONCLUSIONS


Antiviral treatment of neonates with congenital CMV infection and few symptoms including isolated hearing loss remains controversial. A generally accepted therapy, however, is pivotal before introducing universal or targeted screening for congenital CMV infection.",2020,Treatment was associated with significantly less hearing deterioration.,"['Infants with Congenital Cytomegalovirus Infection', 'infants with congenital CMV infection and isolated hearing who received', 'randomized infants with symptomatic congenital CMV infection (involving the central nervous system']","['valganciclovir', 'ganciclovir']",['hearing deterioration'],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0158945', 'cui_str': 'Congenital cytomegalovirus infection (disorder)'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}]","[{'cui': 'C0909381', 'cui_str': 'valganciclovir'}, {'cui': 'C0017066', 'cui_str': 'Ganciclovir'}]",[],,0.0304385,Treatment was associated with significantly less hearing deterioration.,"[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Bührer', 'Affiliation': 'Klinik für Neonatologie, Charité - Universitätsmedizin Berlin, Berlin.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Blankenstein', 'Affiliation': 'Neugeborenen-Screeninglabor Berlin-Brandenburg, Charité - Universitätsmedizin, Berlin.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Rossi', 'Affiliation': 'Kinder- und Jugendmedizin - Perinatalzentrum, Vivantes Klinikum Neukölln, Berlin.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Zeitschrift fur Geburtshilfe und Neonatologie,['10.1055/a-0966-9915']
340,31279324,Effects of hydrocortisone on autobiographical memory retrieval in patients with posttraumatic stress disorder and borderline personality disorder: the role of childhood trauma.,"In a previous study, we found that patients with posttraumatic stress disorder (PTSD) and borderline personality disorder (BPD) showed better autobiographical memory (AM) retrieval after hydrocortisone administration than after placebo administration. Here we investigate the neural correlates of AM retrieval after hydrocortisone administration in patients with PTSD or BPD. We recruited 78 female participants for this placebo-controlled crossover study: 40 healthy controls, 20 patients with PTSD, and 18 patients with BPD (all without medication). All participants received an oral placebo or 10 mg hydrocortisone in a randomized order before performing an AM task. Neural activity was monitored during the task by functional magnetic resonance imaging. Neural activation did not differ between the three groups during AM retrieval, neither in the placebo condition nor after hydrocortisone intake. Multiple regression analysis revealed that Childhood Trauma Questionnaire scores correlated positively with hydrocortisone effects on activation in the anterior medial prefrontal cortex (amPFC), ventrolateral prefrontal cortex (vlPFC), posterior cingulate cortex (PCC), angular gyrus, and cerebellum. These results suggest that hydrocortisone-induced neural activation pattern during AM retrieval is related to childhood trauma. Previously described effects in the hippocampus, which were absent in the current study, might be related to PTSD caused by trauma in adulthood. The effects of hydrocortisone on brain activation and how these effects are influenced by childhood trauma, trauma in adulthood, and PTSD symptoms should be determined in future studies.",2019,"Neural activation did not differ between the three groups during AM retrieval, neither in the placebo condition nor after hydrocortisone intake.","['patients with PTSD or BPD', 'patients with posttraumatic stress disorder (PTSD) and borderline personality disorder (BPD', '78 female participants for this placebo-controlled crossover study: 40 healthy controls, 20 patients with PTSD, and 18 patients with BPD (all without medication', 'patients with posttraumatic stress disorder and borderline personality disorder']","['oral placebo', 'hydrocortisone']","['Neural activation', 'autobiographical memory retrieval', 'Childhood Trauma Questionnaire scores', 'autobiographical memory (AM) retrieval', 'anterior medial prefrontal cortex (amPFC), ventrolateral prefrontal cortex (vlPFC), posterior cingulate cortex (PCC), angular gyrus, and cerebellum', 'brain activation', 'Neural activity', 'neural activation pattern']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]","[{'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C3266730', 'cui_str': 'Ventrolateral'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate'}, {'cui': 'C0152305', 'cui_str': 'Prelunate Gyrus'}, {'cui': 'C0007765', 'cui_str': 'Parencephalon'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]",78.0,0.0472001,"Neural activation did not differ between the three groups during AM retrieval, neither in the placebo condition nor after hydrocortisone intake.","[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Metz', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany. sophie.metz@charite.de.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Fleischer', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Gärnter', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Golde', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Duesenberg', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Roepke', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Oliver T', 'Initials': 'OT', 'LastName': 'Wolf', 'Affiliation': 'Department of Cognitive Psychology, Institute of Cognitive Neuroscience, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Otte', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Wingenfeld', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0459-8']
341,32305259,Management of early pregnancy loss with mifepristone and misoprostol: clinical predictors of treatment success from a randomized trial.,"BACKGROUND


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


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


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


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


No baseline clinical factors predicted treatment success in women receiving medical management with misoprostol for early pregnancy loss. Adding mifepristone to the medical management regimen of early pregnancy loss improved treatment success; thus, mifepristone treatment should be considered for management of early pregnancy loss regardless of baseline clinical factors.",2020,No other baseline clinical factors predicted treatment success in the misoprostol-alone or mifepristone pretreatment arms individually.,"['alone for early pregnancy loss (EPL', 'women with a closed cervical os, with 29% of women with EPL requiring a second dose after three days, and 16% eventually requiring a uterine aspiration procedure', 'women with a parity of 0 or 1, 94/108 (87%) in the', 'women undergoing medical management of EPL with', 'women receiving medical management with', '297 evaluable subjects in the primary study, including 148 in the', 'combined and 149 in the misoprostol-alone groups', 'women who had vaginal bleeding at the time of treatment, 15/17 (88%) in the']","['prostaglandin E1 analogue misoprostol', 'misoprostol-alone', 'misoprostol-alone or mifepristone', 'mifepristone and misoprostol', 'mifepristone', 'mifepristone-misoprostol or misoprostol', 'mifepristone-misoprostol', 'misoprostol']","['vaginal bleeding', 'pregnancy']","[{'cui': 'C3830362', 'cui_str': 'Early Pregnancy Loss'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C1185785', 'cui_str': 'External os structure'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2979982', 'cui_str': 'Vaginal bleeding'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0002335', 'cui_str': 'Alprostadil'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0026088', 'cui_str': 'Mifepristone'}]","[{'cui': 'C2979982', 'cui_str': 'Vaginal bleeding'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]",,0.312621,No other baseline clinical factors predicted treatment success in the misoprostol-alone or mifepristone pretreatment arms individually.,"[{'ForeName': 'Sarita', 'Initials': 'S', 'LastName': 'Sonalkar', 'Affiliation': 'Division of Family Planning, Department of Obstetrics and Gynecology, Hospital of the University of Pennsylvania, Philadelphia, PA. Electronic address: sarita.sonalkar@pennmedicine.upenn.edu.'}, {'ForeName': 'Nathanael', 'Initials': 'N', 'LastName': 'Koelper', 'Affiliation': ""Department of Obstetrics and Gynecology, Center for Research on Reproduction and Women's Health, Philadelphia, PA.""}, {'ForeName': 'Mitchell D', 'Initials': 'MD', 'LastName': 'Creinin', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Atrio', 'Affiliation': 'Department of Obstetrics and Gynecology, Montefiore Hospital and Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Mary D', 'Initials': 'MD', 'LastName': 'Sammel', 'Affiliation': 'Department of Biostatistics and Informatics, Center for Integrative Design and Analysis, Colorado School of Public Health, Denver, CO.'}, {'ForeName': 'Arden', 'Initials': 'A', 'LastName': 'McAllister', 'Affiliation': 'Division of Family Planning, Department of Obstetrics and Gynecology, Hospital of the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Courtney A', 'Initials': 'CA', 'LastName': 'Schreiber', 'Affiliation': 'Division of Family Planning, Department of Obstetrics and Gynecology, Hospital of the University of Pennsylvania, Philadelphia, PA.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.04.006']
342,31811650,Randomized controlled trial of a clinical decision support system for painful polyneuropathy.,"INTRODUCTION


Despite the existence of guidelines, painful neuropathy is often inappropriately treated. We sought to determine the effectiveness of a clinical decision support system on guideline-recommended medication use.
METHODS


We randomized neurology providers, stratified by subspecialty, to a best practice alert (BPA) linked to a Smartset or a BPA alone when seeing patients with neuropathy. The primary outcome was the proportion of patients with uncontrolled nerve pain prescribed a guideline-recommended medication. Generalized estimating equations were used to assess effectiveness.
RESULTS


Seventy-five neurology providers (intervention 38, control 37) treated 2697 patients with neuropathy (intervention 1026, control 671). Providers did not acknowledge the BPA in 1928 (71.5%) visits. Only four of eight intervention arm neurologists who treated patients with uncontrolled nerve pain opened the Smartset. The intervention was not associated with guideline-recommended medication use (odds ratio 0.52, 0.18-1.48; intervention 52%, control 54.8%).
DISCUSSION


Our intervention did not improve prescribing practices for painful neuropathy. Physicians typically ignored the BPAs/Smartset; therefore, future studies should mandate their use or employ alternate strategies.",2020,"The intervention was not associated with guideline-recommended medication use (odds ratio 0.52, 0.18-1.48; intervention 52%, control 54.8%).
","['painful polyneuropathy', 'Seventy-five neurology providers (intervention 38, control 37) treated 2697 patients with neuropathy (intervention 1026, control 671']",[],['proportion of patients with uncontrolled nerve pain prescribed a guideline-recommended medication'],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}]",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0751372', 'cui_str': 'Nerve Pain'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}]",2697.0,0.0495132,"The intervention was not associated with guideline-recommended medication use (odds ratio 0.52, 0.18-1.48; intervention 52%, control 54.8%).
","[{'ForeName': 'Evan L', 'Initials': 'EL', 'LastName': 'Reynolds', 'Affiliation': 'Health Services Research Program, Department of Neurology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Burke', 'Affiliation': 'Health Services Research Program, Department of Neurology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Mousumi', 'Initials': 'M', 'LastName': 'Banerjee', 'Affiliation': 'School of Public Health, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Callaghan', 'Affiliation': 'Health Services Research Program, Department of Neurology, University of Michigan, Ann Arbor, Michigan.'}]",Muscle & nerve,['10.1002/mus.26774']
343,31715077,"Pravastatin for early-onset pre-eclampsia: a randomised, blinded, placebo-controlled trial.","OBJECTIVE


Women with pre-eclampsia have elevated circulating levels of soluble fms-like tyrosine kinase-1 (sFlt-1). Statins can reduce sFlt-1 from cultured cells and improve pregnancy outcome in animals with a pre-eclampsia-like syndrome. We investigated the effect of pravastatin on plasma sFlt-1 levels during pre-eclampsia.
DESIGN


Blinded (clinician and participant), proof of principle, placebo-controlled trial.
SETTING


Fifteen UK maternity units.
POPULATION


We used a minimisation algorithm to assign 62 women with early-onset pre-eclampsia (24 +0  -31 +6   weeks of gestation) to receive pravastatin 40 mg daily (n = 30) or matched placebo (n = 32), from randomisation to childbirth.
PRIMARY OUTCOME


Difference in mean plasma sFlt-1 levels over the first 3 days following randomisation.
RESULTS


The difference in the mean maternal plasma sFlt-1 levels over the first 3 days after randomisation between the pravastatin (n = 27) and placebo (n = 29) groups was 292 pg/ml (95% CI -1175 to 592; P = 0.5), and over days 1-14 was 48 pg/ml (95% CI -1009 to 913; P = 0.9). Women who received pravastatin had a similar length of pregnancy following randomisation compared with those who received placebo (hazard ratio 0.84; 95% CI 0.50-1.40; P = 0.6). The median time from randomisation to childbirth was 9 days (interquartile range [IQR] 5-14 days) for the pravastatin group and 7 days (IQR 4-11 days) for the placebo group. There were three perinatal deaths in the placebo-treated group and no deaths or serious adverse events attributable to pravastatin.
CONCLUSIONS


We found no evidence that pravastatin lowered maternal plasma sFlt-1 levels once early-onset pre-eclampsia had developed. Pravastatin appears to have no adverse perinatal effects.
TWEETABLE ABSTRACT


Pravastatin does not improve maternal plasma sFlt-1 or placental growth factor levels following a diagnosis of early preterm pre-eclampsia #clinicaltrial finds.",2020,Women who received pravastatin had a similar length of pregnancy following randomization compared with those who received placebo (Hazard ratio 0.84; 95%CI: 0.50-1.40; p=0.6).,"['animals with a preeclampsia-like syndrome', ' 15 UK maternity units', 'early-onset preeclampsia', 'Women with preeclampsia', ""62 women with early-onset preeclampsia (24 +0  - 31 +6  weeks' gestation""]","['pravastatin 40mg daily (n=30) or matched placebo', 'Statins', 'pravastatin', 'placebo', 'Pravastatin']","['maternal plasma sFlt-1 levels', 'deaths or serious adverse events', 'pregnancy outcome', 'median time from randomization to childbirth', 'perinatal deaths', 'length of pregnancy', 'plasma sFlt-1 levels', 'mean plasma sFlt-1 levels', 'mean maternal plasma sFlt-1 levels']","[{'cui': 'C0003062', 'cui_str': 'Animals'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C0085542', 'cui_str': 'Pravastatin'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0360714', 'cui_str': 'Statins'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1313526', 'cui_str': 'S2FLT'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1148523', 'cui_str': 'Childbirth'}, {'cui': 'C0701826', 'cui_str': 'Perinatal death (event)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",62.0,0.769051,Women who received pravastatin had a similar length of pregnancy following randomization compared with those who received placebo (Hazard ratio 0.84; 95%CI: 0.50-1.40; p=0.6).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'Aston Medical Research Institute, Aston Medical School, Aston University, Birmingham, UK.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Williams', 'Affiliation': ""UCL EGA Institute for Women's Health, University College London Hospitals NHS Foundation Trust, London, UK.""}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Cheed', 'Affiliation': 'Birmingham Clinical Trials Unit, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'L J', 'Initials': 'LJ', 'LastName': 'Middleton', 'Affiliation': 'Birmingham Clinical Trials Unit, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ahmad', 'Affiliation': 'Aston Medical Research Institute, Aston Medical School, Aston University, Birmingham, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Aston Medical Research Institute, Aston Medical School, Aston University, Birmingham, UK.'}, {'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'Vince', 'Affiliation': 'Birmingham Clinical Trials Unit, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hewett', 'Affiliation': 'Institute of Cardiovascular Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Spencer', 'Affiliation': 'Barking, Havering & Redbridge University Hospitals NHS Trust, Romford, UK.'}, {'ForeName': 'K S', 'Initials': 'KS', 'LastName': 'Khan', 'Affiliation': 'Queen Mary University of London, London, UK.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Daniels', 'Affiliation': 'Nottingham Clinical Trials Unit, School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16013']
344,32308126,The effect of the transfemoral prosthetic socket interface designs on skeletal motion and socket comfort: A randomized clinical trial.,"BACKGROUND


The most crucial aspect of a prosthesis is the socket, as it will directly determine gait stability and quality. The current standard of care ischial ramus containment socket is reported to increase coronal stability through gait; however, socket discomfort is the primary complaint among prosthetic users.
OBJECTIVES


The purpose of this study is to compare ischial ramus containment to alternatives in the transfemoral amputee population. All subjects were fit with three different sockets: traditional ischial ramus containment, a dynamic socket, and a sub-ischial. In this study, authors hypothesized socket skeletal motion would be equivalent across interventions.
STUDY DESIGN


Single-blind, repeated-measures, three-period randomized crossover clinical trial.
METHODS


Outcome measures were socket comfort score and skeletal motion, viewed coronally with X-ray measuring the position of the skeleton in relationship to the socket in full weight-bearing and full un-loading.
RESULTS


The mean age was 38.2 and mean Amputee Mobility Predictor score was 40. Mean vertical movement, horizontal movement, single limb prosthetic stance, mean femoral adduction in swing and stance, and median socket comfort score were not statistically different.
CONCLUSION


The socket design did not significantly effect skeletal motion and socket comfort. All socket designs are suitable depending on the patient-centric preferences and prosthetist skill set.
CLINICAL RELEVANCE


The comfort of the standard of care transfemoral amputation socket has been widely reported as problematic. A comparison of alternative designs in a controlled clinical trial environment will assist the clinician in understanding the impact of design regarding skeletal motion and comfort. Users could benefit from alternatives applied in clinical practice.",2020,The socket design did not significantly effect skeletal motion and socket comfort.,[],['transfemoral prosthetic socket interface designs'],"['socket comfort score and skeletal motion, viewed coronally with X-ray measuring the position of the skeleton in relationship to the socket in full weight-bearing and full un-loading', 'skeletal motion and socket comfort', 'Mean vertical movement, horizontal movement, single limb prosthetic stance, mean femoral adduction in swing and stance, and median socket comfort score', 'effect skeletal motion and socket comfort']",[],"[{'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0085086', 'cui_str': 'Weight-bearing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0231457', 'cui_str': 'Adduction'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.166151,The socket design did not significantly effect skeletal motion and socket comfort.,"[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Kahle', 'Affiliation': 'OP Solutions, Tampa, FL, USA.'}, {'ForeName': 'Rebecca Maria', 'Initials': 'RM', 'LastName': 'Miro', 'Affiliation': 'University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Loi T', 'Initials': 'LT', 'LastName': 'Ho', 'Affiliation': 'Prosthetic Design + Research, Tampa, FL, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Porter', 'Affiliation': 'University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Lura', 'Affiliation': 'Florida Gulf Coast University, Fort Myers, FL, USA.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Carey', 'Affiliation': 'University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lunseth', 'Affiliation': 'University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Highsmith', 'Affiliation': 'US Department of Veterans Affairs, Tampa, FL, USA.'}, {'ForeName': 'M Jason', 'Initials': 'MJ', 'LastName': 'Highsmith', 'Affiliation': 'University of South Florida, Tampa, FL, USA.'}]",Prosthetics and orthotics international,['10.1177/0309364620913459']
345,32305379,Sensorimotor performance is improved by targeted memory reactivation during a daytime nap in healthy older adults.,"Sensorimotor consolidation occurs during sleep. However, the benefit of sleep-based consolidation decreases with age due to decreased sleep quality and quantity. This study aimed to enhance sensorimotor performance through repetitive delivery of task-based auditory cues during sleep, known as targeted memory reactivation (TMR). Healthy older adults performed a non-dominant arm throwing task before and after a 1 h nap. While napping, half of participants received TMR throughout the hour. Participants who received TMR during sleep demonstrated a greater overall change in throwing accuracy from the start of the first to the end of the second throwing task session. However, there was no generalization of throwing accuracy to variants of the task or to a novel dart throwing task. Findings support the use of TMR during sleep to enhance task-specific sensorimotor performance in healthy older adults despite age-related decreases in sleep quality and quantity. Future research is needed to evaluate the effects of TMR on rehabilitation protocols.",2020,"However, there was no generalization of throwing accuracy to variants of the task or to a novel dart throwing task.","['Healthy older adults', 'healthy older adults']","['task-based auditory cues', 'TMR']",['sleep quality and quantity'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}]",,0.0188997,"However, there was no generalization of throwing accuracy to variants of the task or to a novel dart throwing task.","[{'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Johnson', 'Affiliation': 'Department of Physical Therapy & Rehabilitation Science, University of Maryland School of Medicine, 100 Penn Street, Baltimore, MD, 21201, United States.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Scharf', 'Affiliation': 'Sleep Disorders Center, Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Maryland Medical Center, 827 Linden Ave, Baltimore, MD, 21201, United States.'}, {'ForeName': 'Avelino C', 'Initials': 'AC', 'LastName': 'Verceles', 'Affiliation': 'Sleep Disorders Center, Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Maryland Medical Center, 827 Linden Ave, Baltimore, MD, 21201, United States.'}, {'ForeName': 'Kelly P', 'Initials': 'KP', 'LastName': 'Westlake', 'Affiliation': 'Department of Physical Therapy & Rehabilitation Science, University of Maryland School of Medicine, 100 Penn Street, Baltimore, MD, 21201, United States. Electronic address: kwestlake@som.umaryland.edu.'}]",Neuroscience letters,['10.1016/j.neulet.2020.134973']
346,31922613,Rituximab in refractory chronic inflammatory demyelinating polyneuropathy.,"INTRODUCTION


Chronic inflammatory demyelinating polyneuropathy (CIDP) is a disorder in which early effective treatment is important to minimize disability from axonal degeneration. It has been suggested that some patients with CIDP may benefit from rituximab therapy, but there is no definitive evidence for this.
METHODS


Baseline and post-rituximab-therapy neuromuscular Medical Research Council (MRC) sum scores, Inflammatory Neuropathy Cause and Treatment (INCAT) disability score, and functional status were assessed in 11 patients with refactory CIDP.
RESULTS


The MRC sum score, INCAT disability score, and functional status improved in all patients after rituximab therapy.
DISCUSSION


Our study provides evidence of the efficacy of rituximab therapy in at least some patients with CIDP. A placebo-controlled study to assess the effectiveness of rituximab therapy in CIDP with and without nodal antibodies is required to identify disease markers that predict responsiveness.",2020,"The MRC score, INCAT disability score, and functional status improved in all patients after rituximab therapy.
","['11 patients with intractable CIDP', 'Chronic inflammatory demyelinating polyneuropathy (CIDP', 'refractory chronic inflammatory demyelinating polyneuropathy', 'patients with CIDP']","['rituximab therapy', 'placebo', 'Rituximab']","['scores (MRC), Inflammatory Neuropathy Cause and Treatment (INCAT) disability scores, and functional status', 'MRC score, INCAT disability score, and functional status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0393819', 'cui_str': 'Inflammatory Polyradiculopathy, Chronic'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0270922', 'cui_str': 'Peripheral demyelinating neuropathy'}]","[{'cui': 'C4047978', 'cui_str': 'Rituximab therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0270933', 'cui_str': 'Inflammatory neuropathy (disorder)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",,0.101734,"The MRC score, INCAT disability score, and functional status improved in all patients after rituximab therapy.
","[{'ForeName': 'Suraj A', 'Initials': 'SA', 'LastName': 'Muley', 'Affiliation': ""Department of Neurology, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, Arizona.""}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Jacobsen', 'Affiliation': ""Department of Neurology, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, Arizona.""}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Parry', 'Affiliation': 'Department of Neurology, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Uzma', 'Initials': 'U', 'LastName': 'Usman', 'Affiliation': ""Department of Neurology, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, Arizona.""}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Ortega', 'Affiliation': ""Department of Neurology, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, Arizona.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Walk', 'Affiliation': 'Department of Neurology, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Allen', 'Affiliation': 'Department of Neurology, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Mamatha', 'Initials': 'M', 'LastName': 'Pasnoor', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Varon', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Mazen M', 'Initials': 'MM', 'LastName': 'Dimachkie', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, Kansas.'}]",Muscle & nerve,['10.1002/mus.26804']
347,31590179,Influence of combined treatment with naltrexone and memantine on alcohol drinking behaviors: a phase II randomized crossover trial.,"Glutamate and opioid systems play important roles in alcohol drinking behaviors. We examined if combined treatment with the NMDA antagonist memantine and the opioid antagonist naltrexone, when compared with naltrexone alone, would have a greater influence on alcohol drinking behaviors. Fifty-six, non-treatment-seeking heavy drinkers, with alcohol dependence and a positive family history (FHP) of alcoholism, participated in a randomized, double-blind, crossover trial, including two 6-8 days treatment periods, separated by a 6-day washout, and 3 alcohol drinking paradigm (ADP) sessions. After the first baseline (BAS) ADP1 session, participants were randomized to receive either naltrexone (NTX; 50 mg/day) + placebo memantine, or NTX (50 mg/day) + memantine (MEM; 20 mg/day), during the first treatment period, following which they completed ADP2. After a 6-day washout, participants were crossed over to the treatment they did not receive during the first treatment period, following which they completed ADP3. During each ADP, participants received a priming drink of alcohol followed by 3 1-hour, self-administration periods during which they had ad-lib access to 12 drinks. Individually, both NTX and NTX + MEM, when compared to BAS ADP1, significantly reduced the number of drinks consumed (p's < 0.001) and craving (p's < 0.001). When comparing NTX + MEM vs. NTX on number of drinks consumed, there was a significant treatment* sequence interaction (p = 0.004). Specifically, when NTX + MEM followed NTX alone, NTX + MEM resulted in a further reduction in drinking (mean: -1.94; 95% CI: -2.6, -0.8, p = 0.0005). However, when NTX alone followed NTX + MEM, NTX alone did not lead to further reduction in drinking (mean: 0.59; 95% CI: -0.67, 1.43, p = 0.47). Similar patterns were observed for alcohol craving; specifically, a significant reduction in craving was observed when NTX + MEM followed NTX alone (p = 0.009), but craving reduction was maintained when NTX + MEM was followed by NTX alone. Neither treatment condition significantly influenced alcohol-induced stimulation or sedation. Memantine (at a dose of 20 mg/day) enhances the efficacy of naltrexone (50 mg/day) in reducing alcohol drinking and craving among FHP drinkers with beneficial effects that appear to carryover after discontinuation of memantine treatment.",2020,"When comparing NTX + MEM vs. NTX on number of drinks consumed, there was a significant treatment* sequence interaction (p = 0.004).","['Fifty-six, non-treatment-seeking heavy drinkers, with alcohol dependence and a positive family history (FHP) of alcoholism']","['Memantine', 'naltrexone', 'NTX\u2009+\u2009MEM vs. NTX', 'NMDA antagonist memantine', 'NTX', 'alcohol drinking paradigm (ADP) sessions', 'naltrexone (NTX; 50\u2009mg/day)\u2009+\u2009placebo memantine, or NTX (50\u2009mg/day)\u2009+\u2009memantine (MEM', 'opioid antagonist naltrexone', 'naltrexone and memantine', 'priming drink of alcohol']","['craving', 'alcohol craving', 'alcohol drinking behaviors', 'craving reduction', 'number of drinks consumed', 'alcohol drinking and craving', 'alcohol-induced stimulation or sedation']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0337678', 'cui_str': 'Heavy drinker (finding)'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0559555', 'cui_str': 'FH - Alcoholism'}]","[{'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C1979923', 'cui_str': 'Micro-Electro-Mechanical Systems'}, {'cui': 'C0079883', 'cui_str': 'N-Methyl-D-aspartate'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0027410', 'cui_str': 'Opioid Receptor Antagonists'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0565662', 'cui_str': 'Finding relating to alcohol drinking behavior'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]",12.0,0.0285429,"When comparing NTX + MEM vs. NTX on number of drinks consumed, there was a significant treatment* sequence interaction (p = 0.004).","[{'ForeName': 'Suchitra', 'Initials': 'S', 'LastName': 'Krishnan-Sarin', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA. suchitra.krishnan-sarin@yale.edu.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': ""O'Malley"", 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Franco', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Dana A', 'Initials': 'DA', 'LastName': 'Cavallo', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Jeanette M', 'Initials': 'JM', 'LastName': 'Tetrault', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Pittman', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0536-z']
348,32273184,"Immunogenicity and safety of an adjuvanted inactivated polio vaccine, IPV-Al, following vaccination in children at 2, 4, 6 and at 15-18 months.","BACKGROUND


Availability of affordable inactivated polio vaccines (IPV) is of major importance to meet the increasing global supply needs. The results presented here demonstrate non-inferiority of a reduced-dose, aluminium hydroxide-adjuvanted IPV (IPV-Al) to standard IPV.
METHODS


A phase 3, observer-blinded, randomised, clinical trial was conducted in Panama in infants who received either IPV-Al (n = 400) or standard IPV (n = 400) at age 2, 4 and 6 months. In the booster trial, subjects received a single dose of IPV-Al at age 15-18 months. The primary endpoint was type-specific seroconversion, defined as an antibody titre ≥4-fold higher than the estimated maternal antibody titre and a titre ≥8, one month after the primary vaccination series. In the booster trial, the primary endpoint was the type-specific booster effects (geometric mean titre (GMT) post-booster (Day 28)/GMT pre-booster (Day 0).
RESULTS


Seroconversion rates following primary vaccination with IPV-Al vs IPV were: 96.1% vs 100% (type 1); 100% vs 100% (type 2); and 99.2% vs 100% (type 3) respectively. IPV-Al was non-inferior to IPV, as the lower 95% confidence limits of the treatment differences were above the pre-defined -10%-point limit: 3.94% (-6.51; -2.01) for type 1; 0.0% (-1.30; -1.37) for type 2; -0.85 (-2.46; 0.40) for type 3. The booster effects for the group primed with IPV-Al versus the group primed with IPV were 25.3 vs 9.2 (type 1), 19.1 vs 6.5 (type 2) and 50.4 vs 12.5 (type 3). IPV-Al had a comparable safety profile to that of IPV.
CONCLUSIONS


Non-inferiority of IPV-Al to standard IPV with respect to seroconversion after vaccination at 2, 4 and 6 months was confirmed for all three poliovirus serotypes. A robust booster response was demonstrated following vaccination with IPV-Al, regardless of the primary vaccine received. Both vaccines were well tolerated. ClinicalTrials.gov identifiers: NCT03025750 and NCT03671616.
FUNDING


Bill & Melinda Gates Foundation.",2020,"Non-inferiority of IPV-Al to standard IPV with respect to seroconversion after vaccination at 2, 4 and 6 months was confirmed for all three poliovirus serotypes.",['Panama in infants who received either IPV-Al (n\xa0=\xa0400) or'],"['IPV', 'aluminium hydroxide-adjuvanted IPV (IPV-Al', 'standard IPV', 'adjuvanted inactivated polio vaccine, IPV-Al']","['type-specific seroconversion, defined as an antibody titre ≥4-fold higher than the estimated maternal antibody titre', 'Immunogenicity and safety', 'tolerated', 'Seroconversion rates', 'type-specific booster effects (geometric mean titre (GMT']","[{'cui': 'C0030266', 'cui_str': 'Panama'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C3816746', 'cui_str': '400'}]","[{'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0002371', 'cui_str': 'Aluminum Hydroxide'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0729663', 'cui_str': 'Maternal antibody'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.210725,"Non-inferiority of IPV-Al to standard IPV with respect to seroconversion after vaccination at 2, 4 and 6 months was confirmed for all three poliovirus serotypes.","[{'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Sáez-Llorens', 'Affiliation': 'Hospital del Niño Dr. José Renán Esquivel, Calle 34 Este, Panama City, Panama; Cevaxin, Avenida Mexico Calle 33, Local 4, Calidonia, Panama; National System of Investigation at Senacyt, Panama. Electronic address: xsaezll@cwpanama.net.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Thierry-Carstensen', 'Affiliation': 'Statens Serum Institut, 5 Artillerivej, 2300 Copenhagen S, Denmark. Electronic address: BTC@ssi.dk.'}, {'ForeName': 'Lina Saem', 'Initials': 'LS', 'LastName': 'Stoey', 'Affiliation': 'Statens Serum Institut, 5 Artillerivej, 2300 Copenhagen S, Denmark. Electronic address: LSST@ssi.dk.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Sørensen', 'Affiliation': 'AJ Vaccines, 5 Artillerivej, 2300 Copenhagen S, Denmark. Electronic address: CHS@ajvaccines.com.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Wachmann', 'Affiliation': 'Larix A/S, Lyskær 8b, 2730 Herlev, Denmark. Electronic address: HEW@larixcro.com.'}, {'ForeName': 'Ananda S', 'Initials': 'AS', 'LastName': 'Bandyopadhyay', 'Affiliation': 'Bill & Melinda Gates Foundation, Seattle, WA, USA. Electronic address: Ananda.bandyopadhyay@gatesfoundation.org.'}, {'ForeName': 'Pernille Ingemann', 'Initials': 'PI', 'LastName': 'Nielsen', 'Affiliation': 'AJ Vaccines, 5 Artillerivej, 2300 Copenhagen S, Denmark. Electronic address: PXN@ajvaccines.com.'}, {'ForeName': 'Mie Vestergaard', 'Initials': 'MV', 'LastName': 'Kusk', 'Affiliation': 'AJ Vaccines, 5 Artillerivej, 2300 Copenhagen S, Denmark. Electronic address: MHK@ajvaccines.com.'}]",Vaccine,['10.1016/j.vaccine.2020.02.066']
349,32020400,"Microwave ablation plus chemotherapy versus chemotherapy in advanced non-small cell lung cancer: a multicenter, randomized, controlled, phase III clinical trial.","OBJECTIVES


This prospective trial was performed to verify whether microwave ablation (MWA) in combination with chemotherapy could provide superior survival benefit compared with chemotherapy alone.
MATERIALS AND METHODS


From March 1, 2015, to June 20, 2017, treatment-naïve patients with pathologically verified advanced or recurrent non-small cell lung cancer (NSCLC) were randomly assigned to MWA plus chemotherapy group or chemotherapy group. The primary endpoint was progression-free survival (PFS), while the secondary endpoints included overall survival (OS), time to local progression (TTLP), and objective response rate (ORR). The complications and adverse events were also reported.
RESULTS


A total of 293 patients were randomly assigned into the two groups. One hundred forty-eight patients with 117 stage IV tumors were included in the MWA plus chemotherapy group. One hundred forty-five patients with 113 stage IV tumors were included in the chemotherapy group. The median follow-up period was 13.1 months and 12.4 months, respectively. Median PFS was 10.3 months (95% CI 8.0-13.0) in the MWA plus chemotherapy group and 4.9 months (95% CI 4.2-5.7) in the chemotherapy group (HR = 0.44, 95% CI 0.28-0.53; p < 0.0001). Median OS was not reached in the MWA plus chemotherapy group and 12.6 months (95% CI 10.6-14.6) in the chemotherapy group (HR = 0.38, 95% CI 0.27-0.53; p < 0.0001) using Kaplan-Meier analyses with log-rank test. The median TTLP was 24.5 months, and the ORR was 32% in both groups. The adverse event rate was not significantly different in the two groups.
CONCLUSIONS


In patients with advanced NSCLC, longer PFS and OS can be achieved with the treatment of combined MWA and chemotherapy than chemotherapy alone.
KEY POINTS


• Patients treated with MWA plus chemotherapy had superior PFS and OS over those treated with chemotherapy alone. • The ORR of patients treated with MWA plus chemotherapy was similar to that of those treated with chemotherapy alone. • Complications associated with MWA were common but tolerable and manageable.",2020,"Median PFS was 10.3 months (95% CI 8.0-13.0) in the MWA plus chemotherapy group and 4.9 months (95% CI 4.2-5.7) in the chemotherapy group (HR = 0.44, 95% CI 0.28-0.53; p < 0.0001).","['From March 1, 2015, to June 20, 2017, treatment-naïve patients with pathologically verified advanced or recurrent non-small cell lung cancer (NSCLC', 'One hundred forty-eight patients with 117 stage IV tumors were included in the MWA plus chemotherapy group', 'advanced non-small cell lung cancer', 'A total of 293 patients', 'One hundred forty-five patients with 113 stage IV tumors were included in the chemotherapy group']","['chemotherapy', 'MWA plus chemotherapy group or chemotherapy', 'microwave ablation (MWA', 'Microwave ablation plus chemotherapy versus chemotherapy', 'MWA plus chemotherapy']","['overall survival (OS), time to local progression (TTLP), and objective response rate (ORR', 'progression-free survival (PFS', 'median TTLP', 'Median PFS', 'complications and adverse events', 'superior PFS and OS', 'Median OS', 'adverse event rate', 'ORR']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319567', 'cui_str': '45'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3854551', 'cui_str': 'Microwave ablation'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}]",293.0,0.295302,"Median PFS was 10.3 months (95% CI 8.0-13.0) in the MWA plus chemotherapy group and 4.9 months (95% CI 4.2-5.7) in the chemotherapy group (HR = 0.44, 95% CI 0.28-0.53; p < 0.0001).","[{'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Wei', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Ye', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China. yexintaian2014@163.com.'}, {'ForeName': 'Qingliang', 'Initials': 'Q', 'LastName': 'Feng', 'Affiliation': 'Department of Oncology, Liaocheng Cancer Hospital, Liaocheng, Shandong, China.'}, {'ForeName': 'Yanjun', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Oncology, Liaocheng Cancer Hospital, Liaocheng, Shandong, China.'}, {'ForeName': 'Licheng', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Oncology, The People's Liberation Army 88 Hospital, Tai'an, Shandong, China.""}, {'ForeName': 'Wenqiao', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': ""Department of Oncology, The People's Liberation Army 88 Hospital, Tai'an, Shandong, China.""}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': ""Department of Oncology, Dezhou People's Hospital, Dezhou, Shandong, China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Meng', 'Affiliation': ""Department of Oncology, Dezhou People's Hospital, Dezhou, Shandong, China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': ""Department of Oncology, Dezhou People's Hospital, Dezhou, Shandong, China.""}, {'ForeName': 'Chuntang', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""Department of Thoracic Surgery, The Second People's Hospital of Dezhou, Dezhou, Shandong, China.""}, {'ForeName': 'Guangxu', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': ""Department of Thoracic Surgery, The Second People's Hospital of Dezhou, Dezhou, Shandong, China.""}, {'ForeName': 'Kaixian', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': ""Department of Oncology, Tengzhou Central People's Hospital, Zaozhuang, Shandong, China.""}, {'ForeName': 'Peishun', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': ""Department of Oncology, Tengzhou Central People's Hospital, Zaozhuang, Shandong, China.""}, {'ForeName': 'Jingwang', 'Initials': 'J', 'LastName': 'Bi', 'Affiliation': 'Department of Oncology, Jinan Military General Hospital, Jinan, Shandong, China.'}, {'ForeName': 'Guoliang', 'Initials': 'G', 'LastName': 'Xue', 'Affiliation': 'Department of Oncology, Jinan Military General Hospital, Jinan, Shandong, China.'}, {'ForeName': 'Yahong', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Oncology, Affiliated Hospital of Shandong Academy of Medical Sciences, Jinan, Shandong, China.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Sheng', 'Affiliation': 'Department of Oncology, Liaocheng Cancer Hospital, Liaocheng, Shandong, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Department of Oncology, Affiliated Hospital of Shandong Academy of Medical Sciences, Jinan, Shandong, China.'}, {'ForeName': 'Guohua', 'Initials': 'G', 'LastName': 'Yu', 'Affiliation': ""Department of Oncology, Weifang People's Hospital, Weifang, Shandong, China.""}, {'ForeName': 'Haipeng', 'Initials': 'H', 'LastName': 'Ren', 'Affiliation': ""Department of Oncology, Weifang People's Hospital, Weifang, Shandong, China.""}, {'ForeName': 'Junye', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, Affiliated Hospital of Jining Medical University, Jining, Shandong, China.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Department of Oncology, Affiliated Hospital of Jining Medical University, Jining, Shandong, China.'}, {'ForeName': 'Shaoshui', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Oncology, Binzhou Medical University Hospital, Binzhou, Shandong, China.'}, {'ForeName': 'Dianzhong', 'Initials': 'D', 'LastName': 'Geng', 'Affiliation': 'Department of Oncology, Binzhou Medical University Hospital, Binzhou, Shandong, China.'}, {'ForeName': 'Benhua', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': ""Department of Oncology, Affiliated Hospital of Taishan Medical University, Tai'an, Shandong, China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""Department of Oncology, Affiliated Hospital of Taishan Medical University, Tai'an, Shandong, China.""}, {'ForeName': 'Liangming', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, Yantai Yuhuangding Hospital, Yantai, Shandong, China.'}, {'ForeName': 'Dengjun', 'Initials': 'D', 'LastName': 'Sun', 'Affiliation': 'Department of Oncology, Yantai Yuhuangding Hospital, Yantai, Shandong, China.'}, {'ForeName': 'Xinglu', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""Department of Oncology, The People's Hospital of Pingyi Country, Linyi, Shandong, China.""}, {'ForeName': 'Cunqi', 'Initials': 'C', 'LastName': 'Diao', 'Affiliation': ""Department of Oncology, The People's Hospital of Pingyi Country, Linyi, Shandong, China.""}, {'ForeName': 'Guanghui', 'Initials': 'G', 'LastName': 'Huang', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Wenhong', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Meng', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Ni', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Aimin', 'Initials': 'A', 'LastName': 'Zheng', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Weijun', 'Initials': 'W', 'LastName': 'Fan', 'Affiliation': 'Department of Imaging and Interventional Radiology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yuliang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Interventional Medicine, The Second Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': ""Department of Health Statistics, School of Preventive Medicine, Fourth Military Medical University, Xi'an, Shanxi, China.""}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Fan', 'Affiliation': ""Public Health School, Taishan Medical University, Tai'an, Shandong, China.""}, {'ForeName': 'Zhigeng', 'Initials': 'Z', 'LastName': 'Zou', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Qingyu', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Tian', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}]",European radiology,['10.1007/s00330-019-06613-x']
350,31486777,Magnetic seizure therapy (MST) for major depressive disorder.,"Electroconvulsive therapy (ECT) is effective for major depressive disorder (MDD) but its effects on memory limit its widespread use. Magnetic seizure therapy (MST) is a potential alternative to ECT that may not adversely affect memory. In the current trial, consecutive patients with MDD consented to receive MST applied over the prefrontal cortex according to an open-label protocol. Depressive symptoms and cognition were assessed prior to, during and at the end of treatment. Patients were treated two to three times per week with high-frequency MST (i.e., 100 Hz) (N = 24), medium frequency MST (i.e., 60 or 50 Hz) (N = 26), or low-frequency MST (i.e., 25 Hz MST) (N = 36) using 100% stimulator output. One hundred and forty patients were screened; 86 patients with MDD received a minimum of eight treatments and were deemed to have an adequate course of MST; and 47 completed the trial per protocol, either achieving remission (i.e., 24-item Hamilton Rating Scale for Depression score <10 and a relative reduction of >60% at two consecutive assessments; n = 17) or received a maximum of 24 sessions (n = 30). High-frequency (100 Hz) MST produced the highest remission rate (33.3%). Performance on most cognitive measures remained stable, with the exception of significantly worsened recall consistency of autobiographical information and significantly improved brief visuospatial memory task performance. Under open conditions, MST led to clinically meaningful reduction in depressive symptoms in patients with MDD and produced minimal cognitive impairment. Future studies should compare MST and ECT under double-blind randomized condition.",2020,"Performance on most cognitive measures remained stable, with the exception of significantly worsened recall consistency of autobiographical information and significantly improved brief visuospatial memory task performance.","['consecutive patients with MDD consented to receive', 'major depressive disorder', 'One hundred and forty patients were screened; 86 patients with MDD received a minimum of eight treatments and were deemed to have an adequate course of MST; and 47 completed the trial per protocol, either achieving remission (i.e., 24-item Hamilton Rating Scale for Depression score <10 and a relative reduction of >60% at two consecutive assessments; n\u2009=\u200917) or received a maximum of 24 sessions (n\u2009=\u200930']","['Magnetic seizure therapy (MST', 'Electroconvulsive therapy (ECT', 'MST']","['depressive symptoms', 'High-frequency', 'Depressive symptoms and cognition', 'minimal cognitive impairment', 'highest remission rate', 'brief visuospatial memory task performance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C4545802', 'cui_str': 'HAM-D (Hamilton Rating Scale for Depression) score'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1291708', 'cui_str': 'Minimal cognitive impairment'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",140.0,0.0334955,"Performance on most cognitive measures remained stable, with the exception of significantly worsened recall consistency of autobiographical information and significantly improved brief visuospatial memory task performance.","[{'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada. Jeff.Daskalakis@camh.ca.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Dimitrova', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Shawn M', 'Initials': 'SM', 'LastName': 'McClintock', 'Affiliation': 'Neurocognitive Research Laboratory, Department of Psychiatry, University of Texas Southwestern Medical Center, and Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Yinming', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Voineskos', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Tarek K', 'Initials': 'TK', 'LastName': 'Rajji', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Goldbloom', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Albert H C', 'Initials': 'AHC', 'LastName': 'Wong', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Knyahnytska', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Downar', 'Affiliation': 'Toronto General Hospital, University Health Network, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Fitzgerald', 'Affiliation': 'Epworth Centre for Innovation in Mental Health, Epworth Healthcare and Monash Alfred Psychiatry Research Centre, The Alfred and Monash University Central Clinical School, Commercial Rd Melbourne, VIC, Australia.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0515-4']
351,31509297,Three times as much physical education reduced the risk of children being overweight or obese after 5 years.,"AIM


We evaluated the effect that increasing physical education lessons from 1.5 to 4.5 hours per week for 5 years had on the body mass index (BMI) and waist circumferences of children aged 5-11 years at inclusion.
METHODS


From 2008 to 2013, six intervention schools in Svendborg, Denmark, delivered 4.5 hours of physical education lessons per week to 750 children. Meanwhile, four matched control schools gave 549 children the standard 1.5 hours of physical education lessons per week. Measurements were taken at baseline and yearly for 5 years. Of the 1299 children, 81 joined the schools after 2008.
RESULTS


At baseline, the percentage of overweight children was 12% in the intervention schools and 13% in the control schools, whereas 15% and 19% were abdominal obese, respectively. After 5 years, the respective risks of remaining abdominal obese or overweight were 43% and 51% in the intervention schools and 78% and 84% in the control schools. Mean BMI increased 0.450 kg/m 2  more in the control group over the five-year period. The intervention was not effective in decreasing the average waist circumference.
CONCLUSION


Three times as much physical education lessons per week, for 5 years, effectively decreased BMI and the likelihood of remaining overweight or obese.",2020,"At baseline, the percentage of overweight children was 12% in the intervention schools and 13% in the control schools, whereas 15% and 19% were abdominal obese, respectively.","['five years had on the body mass index (BMI) and waist circumferences of children aged 5-11 years at inclusion', 'From 2008-2013', '1,299 children, 81 joined the schools after 2008']",[],"['average waist circumference', 'Mean BMI', 'respective risks of remaining abdominal obese or overweight', 'percentage of overweight children']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0036375', 'cui_str': 'School'}]",[],"[{'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",549.0,0.0133348,"At baseline, the percentage of overweight children was 12% in the intervention schools and 13% in the control schools, whereas 15% and 19% were abdominal obese, respectively.","[{'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Kühr', 'Affiliation': 'Department of Sport Science and Clinical Biomechanics, Research Unit for Exercise Epidemiology, Centre of Research in Childhood Health, Faculty of Health, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Rodrigo Antunes', 'Initials': 'RA', 'LastName': 'Lima', 'Affiliation': 'Ministry of Education of Brazil, CAPES Foundation, Brasília - DF, Brazil.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Grøntved', 'Affiliation': 'Department of Sport Science and Clinical Biomechanics, Research Unit for Exercise Epidemiology, Centre of Research in Childhood Health, Faculty of Health, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Wedderkopp', 'Affiliation': 'Department of Sport Science and Clinical Biomechanics, Research Unit for Exercise Epidemiology, Centre of Research in Childhood Health, Faculty of Health, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Klakk', 'Affiliation': 'Department of Sport Science and Clinical Biomechanics, Research Unit for Exercise Epidemiology, Centre of Research in Childhood Health, Faculty of Health, University of Southern Denmark, Odense, Denmark.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15005']
352,31514201,The effect of methylphenidate on social cognition and oxytocin in children with attention deficit hyperactivity disorder.,"The current study aimed to explore the possible effect of stimulants on oxytocin (OT), a neuropeptide which regulates social behavior, as a mediator of the pro-social effect of methylphenidate (MPH) in children with attention deficit hyperactivity disorder (ADHD) compared to healthy controls (HCs). Utilizing a double-blind placebo-controlled design, we compared the performance of 50 children with ADHD and 40 HCs in ""theory of mind"" (ToM) tasks and examined the effect of a single dose of MPH/placebo on ToM and salivary OT levels in children with ADHD at baseline and following an interpersonal interaction. Children with ADHD displayed significantly poorer ToM performance; however, following MPH administration, their performance normalized and differences between children with ADHD and HC were no longer found. Salivary OT levels at baseline did not differ between children with ADHD and HCs. However, after a parent-child interaction, OT levels were significantly higher in the HC group compared to children with ADHD. Administration of MPH attenuated this difference such that after parent-child interaction differences in OT levels between children with ADHD and HC were no longer found. In the ADHD group, OT levels decreased from administration of placebo to the parent-child interaction. However, the administration of MPH to children with ADHD was associated with an increase in OT levels after the parent-child interaction. We conclude that OT might play a role as a mediator of social deficits in children with ADHD and that the reactivity of the OT system to social interaction in children with ADHD might be impaired. Stimulants may improve ToM and social functions in children with ADHD via its impact on the OT system. PRS: OT and Social Cognition in Children with ADHD: Impact of MPH.",2020,"However, after a parent-child interaction, OT levels were significantly higher in the HC group compared to children with ADHD.","['Children with ADHD', 'children with attention deficit hyperactivity disorder (ADHD', '50 children with ADHD and 40 HCs in ""theory of mind"" (ToM) tasks', 'children with ADHD at baseline and following an interpersonal interaction', 'children with attention deficit hyperactivity disorder', 'children with ADHD']","['methylphenidate', 'HC', 'MPH', 'MPH/placebo', 'oxytocin (OT', 'placebo', 'methylphenidate (MPH']","['ToM and social functions', 'poorer ToM performance', 'Salivary OT levels', 'social cognition and oxytocin', 'ToM and salivary OT levels', 'OT levels']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0935573', 'cui_str': 'Mentalizing'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]",50.0,0.04804,"However, after a parent-child interaction, OT levels were significantly higher in the HC group compared to children with ADHD.","[{'ForeName': 'Orit', 'Initials': 'O', 'LastName': 'Levi-Shachar', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Hila Z', 'Initials': 'HZ', 'LastName': 'Gvirts', 'Affiliation': 'Department of Behavioral Sciences and Psychology, Ariel University, Ariel, Israel.'}, {'ForeName': 'Yiftach', 'Initials': 'Y', 'LastName': 'Goldwin', 'Affiliation': 'Shalvata Mental Health Center, Hod-Hasharon, Israel.'}, {'ForeName': 'Yuval', 'Initials': 'Y', 'LastName': 'Bloch', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Shamay-Tsoory', 'Affiliation': 'Department of Psychology, Haifa University, Haifa, Israel.'}, {'ForeName': 'Orna', 'Initials': 'O', 'LastName': 'Zagoory-Sharon', 'Affiliation': 'Baruch Ivcher School of Psychology, Interdisciplinary Center, Herzlia, Israel.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Feldman', 'Affiliation': 'Baruch Ivcher School of Psychology, Interdisciplinary Center, Herzlia, Israel.'}, {'ForeName': 'Hagai', 'Initials': 'H', 'LastName': 'Maoz', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel. hagaima@gmail.com.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0522-5']
353,31914878,Development of Predictive Equations for Nocturnal Hypertension and Nondipping Systolic Blood Pressure.,"Background Nocturnal hypertension, defined by a mean asleep systolic blood pressure (SBP)/diastolic blood pressure (BP) ≥120/70 mm Hg, and nondipping SBP, defined by an awake-to-asleep decline in SBP <10%, are each associated with increased risk for cardiovascular disease. Methods and Results We developed predictive equations to identify adults with a high probability of having nocturnal hypertension or nondipping SBP using data from the CARDIA (Coronary Artery Risk Development in Young Adults) study (n=787), JHS (Jackson Heart Study) (n=1063), IDH (Improving the Detection of Hypertension) study (n=395), and MHT (Masked Hypertension) study (n=772) who underwent 24-hour ambulatory BP monitoring. Participants were randomized to derivation (n=2511) or validation (n=506) data sets. The prevalence rates of nocturnal hypertension and nondipping SBP were 39.7% and 44.9% in the derivation data set, respectively, and 36.6% and 44.5% in the validation data set, respectively. The predictive equation for nocturnal hypertension included age, race/ethnicity, smoking status, neck circumference, height, high-density lipoprotein cholesterol, albumin/creatinine ratio, and clinic SBP and diastolic BP. The predictive equation for nondipping SBP included age, sex, race/ethnicity, waist circumference, height, alcohol use, high-density lipoprotein cholesterol, and albumin/creatinine ratio. Concordance statistics (95% CI) for nocturnal hypertension and nondipping SBP predictive equations in the validation data set were 0.84 (0.80-0.87) and 0.73 (0.69-0.78), respectively. Compared with reference models including antihypertensive medication use and clinic SBP and diastolic BP as predictors, the continuous net reclassification improvement (95% CI) values for the nocturnal hypertension and nondipping SBP predictive equations were 0.52 (0.35-0.69) and 0.51 (0.34-0.69), respectively. Conclusions These predictive equations can direct ambulatory BP monitoring toward adults with high probability of having nocturnal hypertension and nondipping SBP.",2020,"Concordance statistics (95% CI) for nocturnal hypertension and nondipping SBP predictive equations in the validation data set were 0.84 (0.80-0.87) and 0.73 (0.69-0.78), respectively.","['adults with high probability of having nocturnal hypertension and nondipping SBP', 'adults with a high probability of having nocturnal hypertension or nondipping SBP using data from the CARDIA (Coronary Artery Risk Development in Young Adults) study (n=787']",['24-hour ambulatory BP monitoring'],"['antihypertensive medication use and clinic SBP and diastolic BP', ' Nocturnal hypertension', 'mean asleep systolic blood pressure (SBP)/diastolic blood pressure (BP) ≥120/70\xa0mm\xa0Hg, and nondipping SBP', 'Nocturnal Hypertension and Nondipping Systolic Blood Pressure', 'density lipoprotein cholesterol, albumin/creatinine ratio, and clinic SBP and diastolic BP', 'Concordance statistics', 'nocturnal hypertension and nondipping SBP predictive equations', 'prevalence rates of nocturnal hypertension and nondipping SBP']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0007144', 'cui_str': 'Cardia'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}]","[{'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0065055', 'cui_str': 'lipoprotein cholesterol'}, {'cui': 'C0486293', 'cui_str': 'Albumin/creatinine ratio measurement'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",,0.0416412,"Concordance statistics (95% CI) for nocturnal hypertension and nondipping SBP predictive equations in the validation data set were 0.84 (0.80-0.87) and 0.73 (0.69-0.78), respectively.","[{'ForeName': 'Byron C', 'Initials': 'BC', 'LastName': 'Jaeger', 'Affiliation': 'Department of Biostatistics University of Alabama at Birmingham AL.'}, {'ForeName': 'John N', 'Initials': 'JN', 'LastName': 'Booth', 'Affiliation': 'Department of Epidemiology University of Alabama at Birmingham AL.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Butler', 'Affiliation': 'Department of Population Health Sciences New York University School of Medicine New York NY.'}, {'ForeName': 'Lloyd J', 'Initials': 'LJ', 'LastName': 'Edwards', 'Affiliation': 'Department of Biostatistics University of Alabama at Birmingham AL.'}, {'ForeName': 'Cora E', 'Initials': 'CE', 'LastName': 'Lewis', 'Affiliation': 'Department of Epidemiology University of Alabama at Birmingham AL.'}, {'ForeName': 'Donald M', 'Initials': 'DM', 'LastName': 'Lloyd-Jones', 'Affiliation': 'Department of Preventive Medicine Northwestern University Evanston IL.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Sakhuja', 'Affiliation': 'Department of Epidemiology University of Alabama at Birmingham AL.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Schwartz', 'Affiliation': 'Department of Psychiatry Stony Brook School of Medicine Stony Brook NY.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Shikany', 'Affiliation': 'Division of Preventive Medicine Department of Medicine University of Alabama at Birmingham AL.'}, {'ForeName': 'Daichi', 'Initials': 'D', 'LastName': 'Shimbo', 'Affiliation': 'Department of Medicine Columbia University Medical Center New York NY.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Yano', 'Affiliation': 'Department of Community and Family Medicine Duke University Durham NC.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Muntner', 'Affiliation': 'Department of Epidemiology University of Alabama at Birmingham AL.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.013696']
354,31435957,Comparative study of preterm infants fed new and existing human milk fortifiers showed favourable markers of gastrointestinal status.,"AIM


This study examined the influence of different human milk fortifiers on biomarkers of gastrointestinal immaturity and inflammation in preterm infants.
METHODS


We report secondary outcomes from a controlled, double-blind, randomised, parallel group study conducted from 2011 to 2014 in neonatal intensive care units at 11 metropolitan hospitals in France, Belgium, Germany, Switzerland and Italy. Preterm infants born at up to 32 weeks or weighing up to 1500 g were randomised to a new powdered human milk fortifier (n = 77) or a control fortifier (n = 76) for a minimum of 21 days. We analysed faecal markers of gut inflammation, namely alpha-1 antitrypsin and calprotectin, and maturity, namely elastase-1.
RESULTS


Faecal alpha-1 antitrypsin was slightly lower in the new than control fortifier group after 21 days of full enteral feeding, with a geometric mean and standard deviation of 1.52 ± 1.32 vs 1.82 ± 1.44 mg/g stools (P = .01). There was no significant difference in faecal calprotectin (median [Q1-Q3] of 296 [136-565] μg/g stools in both groups combined at study day 21). Faecal elastase-1 was lower in the new fortifier than control fortifier group (202.5 ± 1.6 vs 257.7 ± 1.5 μg/g stools, P = .016).
CONCLUSION


Mean values for each parameter were within the ranges in healthy term infants, indicating favourable markers of gastrointestinal status in both groups. In addition, for faecal calprotectin, the relatively high concentration observed in preterm infants fed fortified human milk suggests that the threshold level for detecting necrotising enterocolitis should be revised.",2020,"RESULTS


Faecal alpha-1 antitrypsin was slightly lower in the new than control fortifier group after 21 days of full enteral feeding, with a geometric mean and standard deviation of 1.52 ±1.32 versus 1.82 ±1.44 mg/g stools (p = 0.01).","['2011-2014 in neonatal intensive care units at 11 metropolitan hospitals in France, Belgium, Germany, Switzerland and Italy', 'Preterm infants born at up to 32 weeks or weighing up to 1500g', 'preterm infants', 'preterm infants fed']","['human milk fortifiers', 'new and existing human milk fortifiers', 'new powdered human milk fortifier (n = 77) or a control fortifier']","['Faecal alpha-1 antitrypsin', 'Faecal elastase-1', 'Mean values', 'faecal calprotectin', 'faecal markers of gut inflammation, namely alpha-1 antitrypsin and calprotectin, and maturity, namely elastase-1']","[{'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0020029', 'cui_str': 'Hospitals, Metropolitan'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}]","[{'cui': 'C3853188', 'cui_str': 'Human milk fortifier'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0002191', 'cui_str': 'alfa1 antitrypsin'}, {'cui': 'C0030306', 'cui_str': 'Elastase'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0950624', 'cui_str': 'Calgranulin'}, {'cui': 'C0449989', 'cui_str': 'Maturity (attribute)'}]",,0.0668623,"RESULTS


Faecal alpha-1 antitrypsin was slightly lower in the new than control fortifier group after 21 days of full enteral feeding, with a geometric mean and standard deviation of 1.52 ±1.32 versus 1.82 ±1.44 mg/g stools (p = 0.01).","[{'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Rigo', 'Affiliation': 'Department of Neonatology, CHR Citadelle, University of Liège, Liège, Belgium.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Hascoët', 'Affiliation': 'Maternité Régionale Universitaire A. Pinard, CHRU, Nancy, France.'}, {'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Picaud', 'Affiliation': 'Service de Neonatologie, Hôpital de la Croix Rousse, Lyon, France.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Mosca', 'Affiliation': 'Neonatal Intensive Care Unit, Department of Clinical Science and Community Health, Fondazione IRCCS ""Ca\' Granda"" Ospedale Maggiore Policlinico, University of Milan, Milano, Italy.'}, {'ForeName': 'Amandine', 'Initials': 'A', 'LastName': 'Rubio', 'Affiliation': 'Hôpital Couple Enfant, CHU de Grenoble, Grenoble, France.'}, {'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'Saliba', 'Affiliation': 'Hôpital Clocheville, CHU de Tours, Tours, France.'}, {'ForeName': 'Michaël', 'Initials': 'M', 'LastName': 'Radkë', 'Affiliation': 'Klinikum Westbrandenburg GmbH, Potsdam, Germany.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Simeoni', 'Affiliation': 'Centre Hospitalier Universitaire Vaudois, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Guillois', 'Affiliation': 'Hôpital Clemenceau, CHU de Caen, Caen, France.'}, {'ForeName': 'Nicholas P', 'Initials': 'NP', 'LastName': 'Hays', 'Affiliation': 'Nestlé Product Technology Center - Nutrition, La Tour-de-Peilz, Switzerland.'}, {'ForeName': 'Mickaël', 'Initials': 'M', 'LastName': 'Hartweg', 'Affiliation': 'Nestlé Clinical Development Unit, Lausanne, Switzerland.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Billeaud', 'Affiliation': 'CIC Pédiatrique 1401 CHU, Bordeaux, France.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Spalinger', 'Affiliation': ""Children's Hospital of Lucerne, Lucerne, Switzerland.""}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.14981']
355,31752964,The DREAM Initiative: study protocol for a randomized controlled trial testing an integrated electronic health record and community health worker intervention to promote weight loss among South Asian patients at risk for diabetes.,"BACKGROUND


Electronic health record (EHR)-based interventions that use registries and alerts can improve chronic disease care in primary care settings. Community health worker (CHW) interventions also have been shown to improve chronic disease outcomes, especially in minority communities. Despite their potential, these two approaches have not been tested together, including in small primary care practice (PCP) settings. This paper presents the protocol of Diabetes Research, Education, and Action for Minorities (DREAM) Initiative, a 5-year randomized controlled trial integrating both EHR and CHW approaches into a network of PCPs in New York City (NYC) in order to support weight loss efforts among South Asian patients at risk for diabetes.
METHODS/DESIGN


The DREAM Initiative was funded by the National Institute of Diabetes and Digestive and Kidney Diseases (National Institutes of Health). A total of 480 individuals at risk for type 2 diabetes will be enrolled into the intervention group, and an equal number will be included in a matched control group. The EHR intervention components include the provision of technical assistance to participating PCPs regarding prediabetes-related registry reports, alerts, and order sets. The CHW intervention components entail group education sessions on diabetes prevention, including weight loss and nutrition. A mixed-methods approach will be used to evaluate the feasibility, adoption, and impact (≥ 5% weight loss) of the integrated study components. Additionally, a cost effectiveness analysis will be conducted using outcomes, implementation costs, and healthcare claims data to determine the incremental cost per person achieving 5% weight loss.
DISCUSSION


This study will be the first to test the efficacy of an integrated EHR-CHW intervention within an underserved, minority population and in a practical setting via a network of small PCPs in NYC. The study's implementation is enhanced through cross-sector partnerships, including the local health department, a healthcare payer, and EHR vendors. Through use of a software platform, the study will also systematically track and monitor CHW referrals to social service organizations. Study findings, including those resulting from cost-effectiveness analyses, will have important implications for translating similar strategies to other minority communities in sustainable ways.
TRIAL REGISTRATION


This study protocol has been approved and is made available on ClinicalTrials.gov by NCT03188094 as of 15 June 2017.",2019,"Through use of a software platform, the study will also systematically track and monitor CHW referrals to social service organizations.","['15 June 2017', '480 individuals at risk for type 2 diabetes', 'South Asian patients at risk for diabetes', 'Minorities (DREAM']","['Community health worker (CHW) interventions', 'integrated EHR-CHW intervention', 'EHR and CHW', 'integrated electronic health record and community health worker intervention']","['weight loss and nutrition', 'weight loss']","[{'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013117', 'cui_str': 'Dreams'}]","[{'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}]",480.0,0.0390764,"Through use of a software platform, the study will also systematically track and monitor CHW referrals to social service organizations.","[{'ForeName': 'Sahnah', 'Initials': 'S', 'LastName': 'Lim', 'Affiliation': 'Department of Population Health, NYU School of Medicine, 180 Madison Avenue, New York, NY, 10016, USA. Sahnah.Lim@nyulangone.org.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Wyatt', 'Affiliation': 'Department of Population Health, NYU School of Medicine, 180 Madison Avenue, New York, NY, 10016, USA.'}, {'ForeName': 'Shinu', 'Initials': 'S', 'LastName': 'Mammen', 'Affiliation': 'Department of Population Health, NYU School of Medicine, 180 Madison Avenue, New York, NY, 10016, USA.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Zanowiak', 'Affiliation': 'Department of Population Health, NYU School of Medicine, 180 Madison Avenue, New York, NY, 10016, USA.'}, {'ForeName': 'Sadia', 'Initials': 'S', 'LastName': 'Mohaimin', 'Affiliation': 'Department of Population Health, NYU School of Medicine, 180 Madison Avenue, New York, NY, 10016, USA.'}, {'ForeName': 'Keith S', 'Initials': 'KS', 'LastName': 'Goldfeld', 'Affiliation': 'Department of Population Health, NYU School of Medicine, 180 Madison Avenue, New York, NY, 10016, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Shelley', 'Affiliation': 'Department of Population Health, NYU School of Medicine, 180 Madison Avenue, New York, NY, 10016, USA.'}, {'ForeName': 'Heather T', 'Initials': 'HT', 'LastName': 'Gold', 'Affiliation': 'Department of Population Health, NYU School of Medicine, 550 First Avenue, New York, NY, 10016, USA.'}, {'ForeName': 'Nadia S', 'Initials': 'NS', 'LastName': 'Islam', 'Affiliation': 'Department of Population Health, NYU School of Medicine, 180 Madison Avenue, New York, NY, 10016, USA.'}]",Trials,['10.1186/s13063-019-3711-y']
356,31634898,A multipredictor model to predict the conversion of mild cognitive impairment to Alzheimer's disease by using a predictive nomogram.,"Predicting the probability of converting from mild cognitive impairment (MCI) to Alzheimer's disease (AD) is still a challenging task. This study aims at providing a personalized MCI-to-AD conversion estimation by using a multipredictor nomogram that integrates neuroimaging features, cerebrospinal fluid (CSF) biomarker, and clinical assessments. To do so, 290 MCI patients were collected from the Alzheimer's Disease Neuroimaging Initiative (ADNI), of whom 76 has converted to AD and 214 remained with MCI. All subjects were randomly divided into a primary and validation cohort. Radiomics signature (Rad-sig) was obtained based on 17 cerebral cortex features selected by using Least Absolute Shrinkage and Selection Operator (LASSO) algorithm. Clinical factors and amyloid-beta peptide (Aβ) concentration were selected by using Spearman correlation between the converted and not-converted patients. Then, a nomogram that combines image features, clinical factor, and Aβ concentration was constructed and validated. Furthermore, we explored the associations between various predictors from the macro- to the microperspective by assessing gene expression patterns. Our results showed that the multipredictor nomogram (C-index 0.978 and 0.956 in both cohorts, respectively) outperformed the nomogram using either Rad-sig or Aβ concentration as individual predictors. Significant associations were found between neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways. Our study may have a clinical impact as a powerful predictive tool for predicting the conversion probability of MCI and providing associations between cognitive impairment, structural changes, Aβ levels, and underlying biological patterns from the macro- to the microperspective.",2020,"Significant associations were found between neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways.","[""290 MCI patients were collected from the Alzheimer's Disease Neuroimaging Initiative (ADNI), of whom 76 has converted to AD and 214 remained with MCI""]",[],"['neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways', 'Clinical factors and amyloid-beta peptide (Aβ) concentration']","[{'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0007776', 'cui_str': 'Cortical Plate'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0078939', 'cui_str': ""Alzheimer's ABP""}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0173736,"Significant associations were found between neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways.","[{'ForeName': 'Kexin', 'Initials': 'K', 'LastName': 'Huang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Lifeng', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Yubo', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Suping', 'Initials': 'S', 'LastName': 'Cai', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Liaojun', 'Initials': 'L', 'LastName': 'Pang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""The Key Laboratory of Biomedical Information Engineering of Ministry of Education, School of Life Sciences and Technology, Xi'an Jiaotong University, Xi'an, 710049, P. R. China.""}, {'ForeName': 'Liyu', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China. huangly@mail.xidian.edu.cn.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0551-0']
357,30239904,Corrigendum: E-Cigarettes May Support Smokers With High Smoking-Related Risk Awareness to Stop Smoking in the Short Run: Preliminary Results by Randomized Controlled Trial.,,2020,,['Smokers With High Smoking-Related Risk Awareness'],[],[],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}]",[],[],,0.0172603,,"[{'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Masiero', 'Affiliation': ''}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Lucchiari', 'Affiliation': ''}, {'ForeName': 'Ketti', 'Initials': 'K', 'LastName': 'Mazzocco', 'Affiliation': ''}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Veronesi', 'Affiliation': ''}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Maisonneuve', 'Affiliation': ''}, {'ForeName': 'Costantino', 'Initials': 'C', 'LastName': 'Jemos', 'Affiliation': ''}, {'ForeName': 'Emanuela Omodeo', 'Initials': 'EO', 'LastName': 'Salè', 'Affiliation': ''}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Spina', 'Affiliation': ''}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Bertolotti', 'Affiliation': ''}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Pravettoni', 'Affiliation': ''}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/nty175']
358,32152176,"Correction: Postoperative intravenous parecoxib sodium followed by oral celecoxib post total knee arthroplasty in osteoarthritis patients (PIPFORCE): a multicentre, double-blind, randomised, placebo-controlled trial.",,2020,,['post total knee arthroplasty in osteoarthritis patients (PIPFORCE'],"['celecoxib', 'placebo', 'parecoxib sodium']",[],"[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0915144', 'cui_str': 'parecoxib sodium'}]",[],,0.657965,,[],BMJ open,['10.1136/bmjopen-2019-030501corr1']
359,31129681,Maternal anemia type during pregnancy is associated with anemia risk among offspring during infancy.,"BACKGROUND


We evaluated the association between etiology of maternal anemia and iron status throughout infancy.
METHODS


Samples from a study designed to examine Praziquantel treatment during pregnancy were used (n = 359). All women were infected with schistosomiasis and randomized to Praziquantel or placebo at 16 ± 2 weeks' gestation. Hemoglobin, serum ferritin (SF), soluble transferrin receptor (sTfR), hepcidin, C-reactive protein, and interleukin-6 were measured in maternal and infant blood. The relationship between both maternal Praziquantel treatment and etiology of anemia and infant iron status was evaluated.
RESULTS


Maternal iron-deficiency anemia was associated with increased risk of infant anemia at 6 months of age. Infants of mothers with the lowest levels of circulating hepcidin during gestation, likely a marker for iron deficiency, had higher sTfR:SF levels and lower hemoglobin levels, particularly at 12 months of age. Maternal non-iron-deficiency anemia (NIDA) did not impact infant anemia risk or iron status. Maternal treatment for schistosomiasis had no effect on infant hematologic status.
CONCLUSIONS


Maternal iron deficiency anemia was associated with an increased risk for anemia or iron deficiency during late infancy. We did not observe an association between maternal NIDA and increased risk for iron deficiency during infancy.",2019,"Hemoglobin, serum ferritin (SF), soluble transferrin receptor (sTfR), hepcidin, C-reactive protein, and interleukin-6 were measured in maternal and infant blood.",['All women were infected with schistosomiasis and randomized to'],"['Praziquantel or placebo', 'Praziquantel']","['sTfR', 'SF levels and lower hemoglobin levels', 'risk of infant anemia', 'Hemoglobin, serum ferritin (SF), soluble transferrin receptor (sTfR), hepcidin, C-reactive protein, and interleukin-6', 'Maternal anemia type', 'etiology of anemia and infant iron status', 'Maternal iron-deficiency anemia', 'Maternal non-iron-deficiency anemia (NIDA']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0036323', 'cui_str': 'Schistoma Infection'}]","[{'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C1116139', 'cui_str': 'Transferrin receptor, soluble (substance)'}, {'cui': 'C0966897', 'cui_str': 'Liver-Expressed Antimicrobial Peptide'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0015127', 'cui_str': 'causes'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia (disorder)'}, {'cui': 'C0068218', 'cui_str': 'NIDA'}]",,0.133641,"Hemoglobin, serum ferritin (SF), soluble transferrin receptor (sTfR), hepcidin, C-reactive protein, and interleukin-6 were measured in maternal and infant blood.","[{'ForeName': 'Ajibola I', 'Initials': 'AI', 'LastName': 'Abioye', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'McDonald', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Sangshin', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA. spark@uos.ac.kr.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Ripp', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Brady', 'Initials': 'B', 'LastName': 'Bennett', 'Affiliation': 'Center for International Health Research, Rhode Island Hospital, The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Hannah W', 'Initials': 'HW', 'LastName': 'Wu', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Sunthorn', 'Initials': 'S', 'LastName': 'Pond-Tor', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Marianne J', 'Initials': 'MJ', 'LastName': 'Sagliba', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Amabelle J', 'Initials': 'AJ', 'LastName': 'Amoylen', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Palmera I', 'Initials': 'PI', 'LastName': 'Baltazar', 'Affiliation': 'Remedios Trinidad Romualdez Hospital, Tacloban City, Leyte, The Philippines.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Tallo', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Luz P', 'Initials': 'LP', 'LastName': 'Acosta', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Remigio M', 'Initials': 'RM', 'LastName': 'Olveda', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Kurtis', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Friedman', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}]",Pediatric research,['10.1038/s41390-019-0433-5']
360,32142372,Omalizumab for Aspirin Hypersensitivity and Leukotriene Overproduction in Aspirin-exacerbated Respiratory Disease. A Randomized Controlled Trial.,"Rationale:  Aspirin-exacerbated respiratory disease is characterized by severe asthma, nonsteroidal antiinflammatory drug hypersensitivity, nasal polyposis, and leukotriene overproduction. Systemic corticosteroid therapy does not completely suppress lifelong aspirin hypersensitivity. Omalizumab efficacy against aspirin-exacerbated respiratory disease has not been investigated in a randomized manner. Objectives:  To evaluate omalizumab efficacy against aspirin hypersensitivity, leukotriene E 4  overproduction, and symptoms during an oral aspirin challenge in patients with aspirin-exacerbated respiratory disease using a randomized design. Methods:  We performed a double-blind, randomized, crossover, placebo-controlled, single-center study at Sagamihara National Hospital between August 2015 and December 2016. Atopic patients (20-79 yr old) with aspirin-exacerbated respiratory disease diagnosed by systemic aspirin challenge were randomized (1:1) to a 3-month treatment with omalizumab or placebo, followed by a >18-week washout period (crossover design). The primary endpoint was the difference in area under logarithm level of urinary leukotriene E 4  concentration versus time curve in the intent-to-treat population during an oral aspirin challenge. Measurements and Main Results:  Sixteen patients completed the study and were included in the analysis. The area under the logarithm level of urinary leukotriene E 4  concentration versus time curve during an oral aspirin challenge was significantly lower in the omalizumab phase (median [interquartile range], 51.1 [44.5-59.8]) than in the placebo phase (80.8 [interquartile range, 65.4-87.8]) ( P  < 0.001). Ten of 16 patients (62.5%) developed oral aspirin tolerance up to cumulative doses of 930 mg in the omalizumab phase ( P  < 0.001). Conclusions:  Omalizumab treatment inhibited urinary leukotriene E 4  overproduction and upper/lower respiratory tract symptoms during an oral aspirin challenge, resulting in aspirin tolerance in 62.5% of the patients with aspirin-exacerbated respiratory disease.",2020,"CONCLUSIONS


Omalizumab treatment inhibited urinary leukotriene E 4  overproduction and upper/lower respiratory tract symptoms during oral aspirin challenge, resulting in aspirin tolerance in 62.5% of aspirin-exacerbated respiratory disease patients.","['Atopic patients aged 20-79 years with aspirin-exacerbated respiratory disease diagnosed by systemic aspirin challenge', 'exacerbated respiratory disease patients', 'controlled, single-centre study at Sagamihara National Hospital between August 2015 and December 2016', 'Sixteen patients completed the study and were included in the analysis']","['omalizumab or placebo', 'aspirin', 'placebo', 'https://www.umin.ac.jp/ctr/index.htm, ID', 'aspirin-hypersensitivity, leukotriene E', 'Omalizumab', 'Systemic corticosteroid therapy']","['aspirin tolerance', 'urinary leukotriene E 4  overproduction and upper/lower respiratory tract symptoms', 'area under logarithm level of urinary leukotriene E 4  concentration vs time curve', 'oral aspirin tolerance']","[{'cui': 'C0392707', 'cui_str': 'Atopy (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3853540', 'cui_str': 'Samter syndrome'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1444749', 'cui_str': 'Exacerbated (qualifier value)'}, {'cui': 'C0035204', 'cui_str': 'Respiration Disorders'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C3544362', 'cui_str': 'Hypersensitivity (SMQ)'}, {'cui': 'C0064855', 'cui_str': 'Leukotrienes E'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0125644', 'cui_str': 'LTE4'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0282335', 'cui_str': 'Respiratory Tract'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]",,0.296549,"CONCLUSIONS


Omalizumab treatment inhibited urinary leukotriene E 4  overproduction and upper/lower respiratory tract symptoms during oral aspirin challenge, resulting in aspirin tolerance in 62.5% of aspirin-exacerbated respiratory disease patients.","[{'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Hayashi', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Yuma', 'Initials': 'Y', 'LastName': 'Fukutomi', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Mitsui', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Kajiwara', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Watai', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Kamide', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Yuto', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Yuto', 'Initials': 'Y', 'LastName': 'Hamada', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Tomita', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Sekiya', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Tsuburai', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Izuhara', 'Affiliation': 'Division of Medical Biochemistry, Department of Biomolecular Sciences, Saga Medical School, Saga, Japan; and.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Wakahara', 'Affiliation': 'Department of Respiratory Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Naozumi', 'Initials': 'N', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Respiratory Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Respiratory Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Masami', 'Initials': 'M', 'LastName': 'Taniguchi', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201906-1215OC']
361,30839494,EVALUATION OF THE EFFECT OF TOPICAL INTERFERON α2b AS A COMPLEMENTARY TREATMENT OF MACULAR EDEMA OF PATIENTS WITH DIABETIC RETINOPATHY: A Double-Blind Placebo-Controlled Randomized Clinical Trial Study.,"PURPOSE


The objective of this study is to evaluate the effect of the topical interferon α2b (IFNα2b) as an adjunctive therapy in the treatment of diabetic macular edema.
METHOD


This was a randomized controlled clinical trial performed on patients with diabetic macular edema. Fifty eyes of 50 patients (one eye/patient) who were receiving treatment for diabetic macular edema were randomly assigned to get topical IFNα2b 1 MU/mL or artificial tear eye drop as an adjunctive therapy. The primary measure outcomes were best-corrected visual acuity and central macular thickness; the secondary goals were to assess the effect of topical IFNα2b on the intraocular pressure and its potential side effects.
RESULTS


Baseline demographic data of the two groups were similar. The improvement in visual acuity of patients on IFN was more than the patients on artificial tear by the end of the fourth week (6.85 and 1.45 Early Treatment Diabetic Retinopathy Study letters, respectively, P = 0.001) and the eighth week (6.75 and 1.05 Early Treatment Diabetic Retinopathy Study letters, respectively, P = 0.005). The central macular thickness was also decreased correspondingly by the end of fourth week (53.1 ± 153 µm for patients on IFN and 26.6 ± 119.1 µm for patients on artificial tear, P = 0.497) and eighth week (27.9 ± 67.7 for patients on IFN and 29.2 ± 98 µm for patients on artificial tear, P = 0.957), but it was not statistically significant. Intraocular pressure was decreased on the fourth week in IFN group for 1.7 mmHg ±3 and increased for 0.1 mmHg ±2.3 in the artificial tear group (P = 0.018). No significant side effect was detected with topical IFN drop.
CONCLUSION


This study evaluated the short-term effects of topical IFNα2b 1 MU/mL. The drug was well tolerated and may have an effect on improvement of best-corrected visual acuity in patients with diabetic macular edema. It also had an intraocular pressure lowering effect on the studied eyes. However, further studies are needed to confirm this finding.",2020,Intraocular pressure was decreased on the fourth week in IFN group for 1.7 mmHg ±3 and increased for 0.1 mmHg ±2.3 in the artificial tear group (P = 0.018).,"['Fifty eyes of 50 patients (one eye/patient) who were receiving treatment for diabetic macular edema', 'α2b AS A COMPLEMENTARY TREATMENT OF MACULAR EDEMA OF PATIENTS WITH DIABETIC RETINOPATHY', 'patients with diabetic macular edema', 'diabetic macular edema']","['topical IFNα2b 1 MU/mL or artificial tear eye drop as an adjunctive therapy', 'Placebo', 'topical IFNα2b', 'topical interferon α2b (IFNα2b']","['side effect', 'intraocular pressure and its potential side effects', 'visual acuity', 'central macular thickness', 'Intraocular pressure', 'best-corrected visual acuity and central macular thickness', 'intraocular pressure lowering effect']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C0271051', 'cui_str': 'Macular Edema'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0439339', 'cui_str': 'mU/mL'}, {'cui': 'C2608262', 'cui_str': 'Lubricating Eye Drops'}, {'cui': 'C0015399', 'cui_str': 'Ophthalmic Drops'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.140353,Intraocular pressure was decreased on the fourth week in IFN group for 1.7 mmHg ±3 and increased for 0.1 mmHg ±2.3 in the artificial tear group (P = 0.018).,"[{'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Afarid', 'Affiliation': 'Department of Ophthalmology, Poostchi Ophthalmology Research Center, Shiraz Medical School, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Aidin', 'Initials': 'A', 'LastName': 'Meshksar', 'Affiliation': 'Department of Ophthalmology, Poostchi Ophthalmology Research Center, Shiraz Medical School, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Salehi', 'Affiliation': 'Research Center for Traditional Medicine and History of Medicine, Shiraz Medical School, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad Mostafa', 'Initials': 'MM', 'LastName': 'Safarpour', 'Affiliation': 'Department of Ophthalmology, Poostchi Ophthalmology Research Center, Shiraz Medical School, Shiraz University of Medical Sciences, Shiraz, Iran.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002465']
362,31305505,CORRELATION OF SUBRETINAL HYPERREFLECTIVE MATERIAL MORPHOLOGY AND VISUAL ACUITY IN NEOVASCULAR AGE-RELATED MACULAR DEGENERATION.,"PURPOSE


To evaluate the association of subretinal hyperreflective material (SHRM) morphological features with visual acuity in eyes with neovascular age-related macular degeneration.
METHODS


Retrospective analysis of treatment-naïve patients with neovascular age-related macular degeneration enrolled in randomized anti-vascular endothelial growth factor (VEGF) and anti-platelet-derived growth factor clinical trials. Standardized spectral domain optical coherence tomography images were graded at baseline, 12-week, and 24-week follow-up visits. Masked readers evaluated the morphology of SHRM (reflectivity, shape, anterior, and posterior boundaries) and measured SHRM height, width, and area at the fovea, within the center 1 mm, and outside the center 1 mm.
RESULTS


Baseline SHRM characteristics that correlated with worse visual acuity at 12 and 24 weeks included layered appearance (P = 0.006, 0.001), hyperreflective spots in SHRM (P = 0.001, 0.011), and separation between SHRM and outer retina (P = 0.03, 0.019). The disappearance of SHRM correlated with better visual acuity at Weeks 12 and 24 (P < 0.001). Layered appearance of SHRM at baseline was significantly associated with increased reflectivity at Weeks 12 and 24 (P = 0.009, 0.003). Decreasing reflectivity of SHRM lesion at Weeks 12 and 24 correlated with better visual acuity (P < 0.01, 0.01). Increased width and area of baseline SHRM at the foveal center correlated with worse visual acuity at 12 (P < 0.001, <0.001) and 24 weeks (<0.001, <0.001).
CONCLUSION


Several attributes of SHRM including, layered appearance, increased reflectivity, larger size, and hyperreflective spots correlated with worse visual acuity at 12- and 24-week follow-ups. Baseline SHRM characteristics can help practitioners predict visual and morphological prognosis and guide therapy.",2020,The disappearance of SHRM correlated with better visual acuity at Weeks 12 and 24 (P < 0.001).,"['Retrospective analysis of treatment-naïve patients with neovascular age-related macular degeneration enrolled in', 'eyes with neovascular age-related macular degeneration']",['randomized anti-vascular endothelial growth factor (VEGF'],"['hyperreflective spots in SHRM', 'morphology of SHRM (reflectivity, shape, anterior, and posterior boundaries) and measured SHRM height, width, and area at the fovea', 'layered appearance', 'Layered appearance of SHRM', 'visual acuity', 'Increased width and area of baseline SHRM', 'disappearance of SHRM', 'layered appearance, increased reflectivity, larger size, and hyperreflective spots', 'Decreasing reflectivity of SHRM lesion']","[{'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}]","[{'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]",,0.15083,The disappearance of SHRM correlated with better visual acuity at Weeks 12 and 24 (P < 0.001).,"[{'ForeName': 'Jaya B', 'Initials': 'JB', 'LastName': 'Kumar', 'Affiliation': 'Department of Ophthalmology, Duke University, Durham, North Carolina.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Stinnett', 'Affiliation': 'Department of Ophthalmology, Duke University, Durham, North Carolina.'}, {'ForeName': 'Jung I L', 'Initials': 'JIL', 'LastName': 'Han', 'Affiliation': 'Department of Ophthalmology, Duke University, Durham, North Carolina.'}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Jaffe', 'Affiliation': 'Department of Ophthalmology, Duke University, Durham, North Carolina.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002552']
363,31103481,A Comparison of Mindfulness-Based Cognitive Therapy Vs Cognitive Behavioral Therapy for the Treatment of Provoked Vestibulodynia in a Hospital Clinic Setting.,"INTRODUCTION


Chronic and distressing genito-pelvic pain associated with vaginal penetration is most frequently due to provoked vestibulodynia (PVD). Cognitive behavioral therapy (CBT) significantly reduces genital pain intensity and improves psychological and sexual well-being. In general chronic pain populations, mindfulness-based approaches may be as effective for improving pain intensity as CBT.
AIM


To compare mindfulness-based cognitive therapy (MBCT) with CBT in the treatment of PVD.
METHODS


To ensure power of 0.95 to find medium effect size or larger in this longitudinal design, we enrolled 130 participants. Of these, 63 were assigned to CBT (mean age 31.2 years), and 67 to MBCT (mean age 33.7 years). Data from all participants who completed baseline measures were analyzed, with intent-to-treat analyses controlling for years since diagnosis.
MAIN OUTCOME MEASURES


Our primary outcome was self-reported pain during vaginal penetration at immediate post-treatment and at 6 months' follow-up. Secondary endpoints included pain ratings with a vulvalgesiometer, pain catastrophizing, pain hypervigilance, pain acceptance, sexual function, and sexual distress.
RESULTS


There was a significant interaction between group and time for self-reported pain, such that improvements with MBCT were greater than those with CBT. For all other endpoints, both groups led to similar significant improvements, and benefits were maintained at 6 months.
CLINICAL IMPLICATIONS


Mindfulness is a promising approach to improving self-reported pain from vaginal penetration and is as effective as CBT for several psychological endpoints.
STRENGTH & LIMITATIONS


A strength of the present study was the robust sample size (n = 130 women) who had received confirmed clinical diagnoses of PVD.
CONCLUSION


The present study showed mindfulness to be as effective for most pain- and sexuality-related endpoints in the treatment of PVD. Brotto LA, Bergeron S, Zdaniuk B, et al. A Comparison of Mindfulness-Based Cognitive Therapy Vs Cognitive Behavioral Therapy for the Treatment of Provoked Vestibulodynia in a Hospital Clinic Setting. J Sex Med 2019;16:909-923.",2019,"Mindfulness is a promising approach to improving self-reported pain from vaginal penetration and is as effective as CBT for several psychological endpoints.
","['Provoked Vestibulodynia in a Hospital Clinic Setting', '63 were assigned to CBT (mean age 31.2 years), and 67 to MBCT (mean age 33.7 years', 'enrolled 130 participants', 'sample size (n\xa0= 130 women) who had received confirmed clinical diagnoses of PVD']","['Mindfulness-Based Cognitive Therapy Vs Cognitive Behavioral Therapy', 'Cognitive behavioral therapy (CBT']","['genital pain intensity and improves psychological and sexual well-being', 'pain ratings with a vulvalgesiometer, pain catastrophizing, pain hypervigilance, pain acceptance, sexual function, and sexual distress', 'self-reported pain during vaginal penetration']","[{'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C2717866', 'cui_str': 'Vestibulodynia'}, {'cui': 'C0587906', 'cui_str': 'Hospital clinic (environment)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0239725', 'cui_str': 'Genital pain'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0235013', 'cui_str': 'Hypervigilance'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0556623', 'cui_str': 'Vaginal penetration (finding)'}]",130.0,0.0332539,"Mindfulness is a promising approach to improving self-reported pain from vaginal penetration and is as effective as CBT for several psychological endpoints.
","[{'ForeName': 'Lori A', 'Initials': 'LA', 'LastName': 'Brotto', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Vancouver, British Columbia, Canada. Electronic address: Lori.Brotto@vch.ca.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Bergeron', 'Affiliation': 'Department of Psychology, Universite de Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Bozena', 'Initials': 'B', 'LastName': 'Zdaniuk', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Driscoll', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Grabovac', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Leslie A', 'Initials': 'LA', 'LastName': 'Sadownik', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Kelly B', 'Initials': 'KB', 'LastName': 'Smith', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Basson', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, British Columbia, Canada.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.04.002']
364,32233095,Impact of the type of anthracycline and of stem cell transplantation in younger patients with acute myeloid leukaemia: Long-term follow up of a phase III study.,"We provide a long-term evaluation of patients enrolled in the EORTC/GIMEMA AML-10 trial which included a total of 2157 patients, 15-60 years old, randomized to receive either daunorubicin (DNR, 50 mg/m 2  ), mitoxantrone (MXR, 12 mg/m 2  ), or idarubicin (IDA, 10 mg/m 2  ) in addition to standard-dose cytarabine and etoposide for induction chemotherapy and intermediate dose cytarabine for consolidation. Younger patients who reached complete remission with complete (CR) or incomplete (CRi) recovery were then scheduled to receive an allogeneic hematopoietic stem cell transplantation (HSCT). That was if they had a HLA-identical sibling donor; in all other cases, an autologous HSCT had to be administered. At an 11-year median follow-up, the 5-year, 10-year and 15-year overall survival (OS) rates were 33.2%, 30.1% and 28.0%, respectively. No significant difference between the three randomized groups regarding OS was observed (P = .38). In young patients, 15-45 years old, no treatment difference (P = .89) regarding OS was observed, while in patients 46-60 years old, MXR and IDA groups had a trend for a longer OS as compared to the DNR group (P = .029). Among younger patients without a favorable MRC cytogenetic risk subgroup who achieved a CR/CRi after induction chemotherapy, those with a HLA-identical sibling donor had higher 10-year and 15-year OS rates than those without. In older patients who reached CR/CRi, the long-term outcomes of those with or without a donor was similar. In conclusion, long-term outcomes of the study confirmed similar OS in the three randomized groups in the whole cohort of patients.",2020,"In young patients, 15-45 years old, no treatment difference (P=0.89) regarding OS was observed, while in patients 46-60 years old, MXR and IDA groups had a trend for a longer OS as compared to the DNR group (P=0.029).","['younger patients with acute myeloid leukaemia', 'Younger patients who reached complete remission with complete (CR) or incomplete (CRi) recovery', 'patients enrolled in the EORTC/GIMEMA AML-10 trial which included a total of 2157 patients, 15-60\u2009years old', 'younger patients without a favourable MRC cytogenetic risk subgroup']","['daunorubicin (DNR, 50 mg/m 2  ), mitoxantrone (MXR, 12 mg/m 2  ), or idarubicin (IDA, 10 mg/m 2  ) in addition to standard-dose cytarabine and etoposide for induction chemotherapy and intermediate dose cytarabine', 'anthracycline and of stem cell transplantation', 'allogeneic hematopoietic stem cell transplantation (HSCT']","['15-year overall survival (OS) rates', 'OS']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0010802', 'cui_str': 'Cytogenetic'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0582114', 'cui_str': 'DNAR - Do not attempt resuscitation'}, {'cui': 'C0026259', 'cui_str': 'Mitoxantrone'}, {'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",2157.0,0.159809,"In young patients, 15-45 years old, no treatment difference (P=0.89) regarding OS was observed, while in patients 46-60 years old, MXR and IDA groups had a trend for a longer OS as compared to the DNR group (P=0.029).","[{'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Baron', 'Affiliation': 'GIGA-I3 and CHU, University of Liège, Liège, Belgium.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Efficace', 'Affiliation': ""Gruppo Italiano Malattie Ematologiche Dell'Adulto GIMEMA, Rome, Italy.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cannella', 'Affiliation': ""Gruppo Italiano Malattie Ematologiche Dell'Adulto GIMEMA, Rome, Italy.""}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Muus', 'Affiliation': 'Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Trisolini', 'Affiliation': 'Sapienza University, Rome, Italy.'}, {'ForeName': 'Constantijn J M', 'Initials': 'CJM', 'LastName': 'Halkes', 'Affiliation': 'Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Fazi', 'Affiliation': ""Gruppo Italiano Malattie Ematologiche Dell'Adulto GIMEMA, Rome, Italy.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Vignetti', 'Affiliation': ""Gruppo Italiano Malattie Ematologiche Dell'Adulto GIMEMA, Rome, Italy.""}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Marie', 'Affiliation': 'Saint-Antoine Hospital, Paris, France.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Chiusolo', 'Affiliation': 'Gemelli Hospital, Rome, Italy.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'van der Velden', 'Affiliation': 'Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'La Sala', 'Affiliation': ""Gruppo Italiano Malattie Ematologiche Dell'Adulto GIMEMA, Rome, Italy.""}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Vitolo', 'Affiliation': 'Candiolo Cancer Institute-IRCCS, Torino, Italy.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Thomas', 'Affiliation': 'Lyon-Sud University Hospital, Lyon, France.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Lefrère', 'Affiliation': ""Assistance Publique-Hôpitaux de Paris, Necker Children's Hospital, Paris, France.""}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Di Raimondo', 'Affiliation': 'Universita di Catania, Catania, Italy.'}, {'ForeName': 'Jean-Henri', 'Initials': 'JH', 'LastName': 'Bourhis', 'Affiliation': 'Gustave Roussy cancer campus Grand Paris, Villejuif, France.'}, {'ForeName': 'Giorgina', 'Initials': 'G', 'LastName': 'Specchia', 'Affiliation': 'Giovanni XXIII- University Hospital, Bari, Italy.'}, {'ForeName': 'José E', 'Initials': 'JE', 'LastName': 'Guimarães', 'Affiliation': 'Hospital S. João, Porto, Portugal.'}, {'ForeName': 'Bernardino', 'Initials': 'B', 'LastName': 'Allione', 'Affiliation': 'Candiolo Cancer Institute-IRCCS, Torino, Italy.'}, {'ForeName': 'Radovan', 'Initials': 'R', 'LastName': 'Vrhovac', 'Affiliation': 'University Hospital Centre Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Felicetto', 'Initials': 'F', 'LastName': 'Ferrara', 'Affiliation': 'Cardarelli Hospital, Naples, Italy.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Stevens-Kroef', 'Affiliation': 'Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Liv', 'Initials': 'L', 'LastName': 'Meert', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Theo', 'Initials': 'T', 'LastName': 'de Witte', 'Affiliation': 'Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Roelof', 'Initials': 'R', 'LastName': 'Willemze', 'Affiliation': 'Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Amadori', 'Affiliation': 'University Tor Vergata, Rome, Italy.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Suciu', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}]",American journal of hematology,['10.1002/ajh.25795']
365,31045214,Effects of Current and Enhanced Tobacco Corrective Messages on Smokers' Intention to Quit Smoking and Intention to Purchase Cigarettes.,"INTRODUCTION


A federal court has ordered tobacco companies to issue corrective messages to address tobacco-related misperceptions. This study examined the effects of viewing current versus two enhanced versions of tobacco corrective messages on smokers' intention to quit smoking and intention to purchase cigarettes.
METHODS


US adult smokers (N = 803) were randomly assigned to view (1) two current tobacco corrective messages (Current), (2) two corrective messages that include an industry deception statement (Industry Deception), or (3) two corrective messages with an industry deception statement and testimonials of people harmed by smoking (Industry Deception + Testimonial). Outcomes were pretest-posttest change in intentions to quit smoking and posttest intention to purchase cigarette measures.
RESULTS


Intention to quit smoking increased significantly after viewing the Current corrective messages versus baseline. In addition, viewing the Industry Deception + Testimonial messages increased intention to quit smoking compared with the Current corrective condition and the Industry Deception condition. Hispanic smokers had increased intention to quit smoking and decreased intention to purchase cigarettes to a greater degree than non-Hispanic smokers in response to Industry Deception + Testimonial messages. There was no significant difference in intention to purchase cigarettes across conditions.
CONCLUSIONS


Enhancing the current corrective statements by including an industry deception statement and testimonials may strengthen effects and contribute to remedying the effects of tobacco misinformation.
IMPLICATIONS


Previous research has found that draft or proposed versions of tobacco industry corrective messages are effective in correcting beliefs and knowledge. However, studies have not examined how the current court-ordered corrective messages could change intention to quit smoking and intention to purchase cigarettes nor whether enhanced messages could perform better. Study findings suggest that the current corrective messages can increase smokers' intention to quit smoking beyond their baseline intention. More importantly, enhancing corrective messages by including an industry deception statement and testimonial was found to be more effective than current corrective messages. Findings can inform future iterations of tobacco correctives and strategies to reverse the effects of tobacco misinformation.",2020,Hispanic smokers had increased intention to quit smoking and decreased intention to purchase cigarettes to a greater degree than non-Hispanic smokers in response to Industry Deception + Testimonial messages.,"[""Smokers' Intention to Quit Smoking and Intention to Purchase Cigarettes"", 'US adult smokers (N=803', ""smokers' intention to quit smoking and intention to purchase cigarettes"", 'Hispanic smokers']","['current tobacco corrective messages (Current), 2) two corrective messages that include an industry deception statement (Industry Deception), or 3) two corrective messages with an industry deception statement and testimonials of smokers harmed by smoking (Industry Deception + Testimonial', 'Current and Enhanced Tobacco Corrective Messages', 'viewing current versus two enhanced versions of tobacco corrective messages']","['intention to quit smoking', 'quit smoking', 'intentions to quit smoking and posttest intention to purchase cigarette measures']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}]","[{'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0021267', 'cui_str': 'Industry'}, {'cui': 'C0024195', 'cui_str': 'Deception'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",803.0,0.0388787,Hispanic smokers had increased intention to quit smoking and decreased intention to purchase cigarettes to a greater degree than non-Hispanic smokers in response to Industry Deception + Testimonial messages.,"[{'ForeName': 'Stella J', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Department of Social and Behavioral Sciences, TH Chan School of Public Health, Harvard University, Boston, MA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Sanders-Jackson', 'Affiliation': 'Department of Advertising and Public Relations, College of Communication Arts and Sciences, Michigan State University, East Lansing, MI.'}, {'ForeName': 'Andy S L', 'Initials': 'ASL', 'LastName': 'Tan', 'Affiliation': 'Department of Social and Behavioral Sciences, TH Chan School of Public Health, Harvard University, Boston, MA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz063']
366,32304829,Study Protocol: A randomized controlled trial of suicide risk reduction in the year following jail release (the SPIRIT Trial).,"PURPOSE


This article describes the protocol for a randomized effectiveness and cost-effectiveness trial of Stanley and Brown's Safety Planning Intervention (SPI) during pretrial jail detention to reduce post-release suicide events (suicide attempts, suicide behaviors, and suicide-related hospitalizations).
BACKGROUND


With 10 million admissions per year and short stays (often days), U.S. jails touch many individuals at risk for suicide, providing an important opportunity for suicide prevention that is currently being missed. This study (N = 800) is the first randomized evaluation of an intervention to reduce suicide risk in the vulnerable year after jail release. Given that roughly 10% of all suicides in the U.S. with known circumstances occur in the context of a criminal legal stressor, reducing suicide risk in the year after arrest and jail detention could have a noticeable impact on national suicide rates.
DESIGN


Pretrial jail detainees at risk for suicide were randomized to SPI during jail detention plus post-release phone follow-up or to enhanced Standard Care. Outcomes assessed through 12 months post-release include suicide events, suicide attempts, weeks of active suicide ideation, severity of suicide ideation, time to first event, psychiatric symptoms, functioning, and cost-effectiveness. Methods accommodate short jail stays and maximize trial safety and follow-up in a large sample with severe suicide risk, access to lethal means including substances and firearms, high rates of psychiatric illness, and unstable circumstances.
CONCLUSION


Adequate funding was important to create the infrastructure needed to run this large trial cleanly. We encourage funders to provide adequate resources to ensure clean, well-run trials.",2020,"Outcomes assessed through 12 months post-release include suicide events, suicide attempts, weeks of active suicide ideation, severity of suicide ideation, time to first event, psychiatric symptoms, functioning, and cost-effectiveness.","['Pretrial jail detainees at risk for suicide', 'With 10 million admissions per year and short stays (often days']","[""Stanley and Brown's Safety Planning Intervention (SPI"", 'SPI during jail detention plus post-release phone follow-up or to enhanced Standard Care']","['suicide risk', 'suicide events, suicide attempts, weeks of active suicide ideation, severity of suicide ideation, time to first event, psychiatric symptoms, functioning, and cost-effectiveness']","[{'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0563664', 'cui_str': 'At risk for suicide'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0439508', 'cui_str': '/year'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0563664', 'cui_str': 'At risk for suicide'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0392348', 'cui_str': 'Ideation'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.211819,"Outcomes assessed through 12 months post-release include suicide events, suicide attempts, weeks of active suicide ideation, severity of suicide ideation, time to first event, psychiatric symptoms, functioning, and cost-effectiveness.","[{'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Johnson', 'Affiliation': 'Michigan State University College of Human Medicine, 200 East 1(st) St Room 366, Flint, MI 48503, United States of America. Electronic address: JJohns@msu.edu.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Brown University Warren Alpert Medical School, 700 Butler Drive, Providence, RI 02906, United States of America. Electronic address: Richard_Jones@brown.edu.'}, {'ForeName': 'Ted', 'Initials': 'T', 'LastName': 'Miller', 'Affiliation': 'Pacific Institute for Research and Evaluation, 11720 Beltsville Drive, Suite 909, Calverton, MD 20705, United States of America. Electronic address: Miller@pire.org.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Miller', 'Affiliation': 'Brown University Warren Alpert Medical School, 345 Blackstone Blvd, Providence, RI 02906, United States of America. Electronic address: Ivan_Miller_iii@brown.edu.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Stanley', 'Affiliation': 'Columbia University, 1051 Riverside Drive, Unit 42, New York, NY 10032, United States of America. Electronic address: Bhs2@columbia.edu.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Brown', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine, 3535 Market Street, Room 2032, Philadelphia, PA 19104, United States of America. Electronic address: gregbrow@mail.med.upenn.edu.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Arias', 'Affiliation': 'Brown University Warren Alpert Medical School and Butler Hospital, 345 Blackstone Blvd, Providence, RI 02906, United States of America.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Cerbo', 'Affiliation': 'Rhode Island Department of Corrections, 1375 Pontiac Avenue, Cranston, RI 029020, United States of America. Electronic address: Louis.Cerbo@bhddh.ri.gov.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Rexroth', 'Affiliation': 'Genesee County Jail and Corizon Health, 1002 South Saginaw Street, Flint, MI 48502, United States of America. Electronic address: Julie.Rexroth@corizonhealth.com.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Fitting', 'Affiliation': 'The Providence Center, 528 N. Main Street, Providence, RI, 02904, United States of America. Electronic address: hfitting@provctr.org.'}, {'ForeName': 'Danis', 'Initials': 'D', 'LastName': 'Russell', 'Affiliation': 'Genesee Health System, 420 West 5(th) Avenue, Flint, MI 48503, United States of America. Electronic address: drussell@ghs.org.'}, {'ForeName': 'Sheryl', 'Initials': 'S', 'LastName': 'Kubiak', 'Affiliation': 'Wayne State University School of Social Work, 5447 Woodward Avenue, Detroit, MI 48202, United States of America. Electronic address: spk@wayne.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stein', 'Affiliation': 'Boston University, 715 Albany Street, Talbot Building T2W, Boston, MA 02118, United States of America. Electronic address: mdstein@bu.edu.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Matkovic', 'Affiliation': 'Rhode Island Hospital, 593 Eddy Street, Providence, RI 02903, United States of America. Electronic address: Christopher_Matkovic@brown.edu.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Yen', 'Affiliation': 'Brown University Warren Alpert Medical School, 700 Butler Drive, Providence, RI 02906, United States of America. Electronic address: Shirley_Yen_PhD@brown.edu.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Gaudiano', 'Affiliation': 'Brown University Warren Alpert Medical School and Butler Hospital, 345 Blackstone Blvd, Providence, RI 02906, United States of America. Electronic address: Brandon_Gaudiano@brown.edu.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Weinstock', 'Affiliation': 'Brown University Warren Alpert Medical School, 700 Butler Drive, Providence, RI 02906, United States of America. Electronic address: Lauren_Weinstock@brown.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106003']
367,31252032,IL-4Rα Blockade by Dupilumab Decreases Staphylococcus aureus Colonization and Increases Microbial Diversity in Atopic Dermatitis.,"Dupilumab is a fully human antibody to interleukin-4 receptor α that improves the signs and symptoms of moderate to severe atopic dermatitis (AD). To determine the effects of dupilumab on Staphylococcus aureus colonization and microbial diversity on the skin, bacterial DNA was analyzed from swabs collected from lesional and nonlesional skin in a double-blind, placebo-controlled study of 54 patients with moderate to severe AD randomized (1:1) and treated with either dupilumab (200 mg weekly) or placebo for 16 weeks. Microbial diversity and relative abundance of Staphylococcus were assessed by DNA sequencing of 16S ribosomal RNA, and absolute S. aureus abundance was measured by quantitative PCR. Before treatment, lesional skin had lower microbial diversity and higher overall abundance of S. aureus than nonlesional skin. During dupilumab treatment, microbial diversity increased and the abundance of S. aureus decreased. Pronounced changes were seen in nonlesional and lesional skin. Decreased S. aureus abundance during dupilumab treatment correlated with clinical improvement of AD and biomarkers of type 2 immunity. We conclude that clinical improvement of AD that is mediated by interleukin-4 receptor α inhibition and the subsequent suppression of type 2 inflammation is correlated with increased microbial diversity and reduced abundance of S. aureus.",2020,"Before treatment, lesional skin had lower microbial diversity and higher overall abundance of S. aureus than nonlesional skin.","['54 patients with moderate-to-severe atopic dermatitis randomized (1:1) and treated with either', 'Atopic Dermatitis']","['dupilumab', 'placebo']","['atopic dermatitis and biomarkers of type 2 immunity', 'microbial diversity', 'Microbial diversity and relative abundance of Staphylococcus', 'nonlesional and lesional skin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0020964', 'cui_str': 'Immunity'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0038170', 'cui_str': 'Staphylococcus'}, {'cui': 'C1123023', 'cui_str': 'Skin'}]",54.0,0.107796,"Before treatment, lesional skin had lower microbial diversity and higher overall abundance of S. aureus than nonlesional skin.","[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Callewaert', 'Affiliation': 'Department of Pediatrics, University of California San Diego, La Jolla, California, USA; Center for Microbial Ecology and Technology, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Teruaki', 'Initials': 'T', 'LastName': 'Nakatsuji', 'Affiliation': 'Department of Dermatology, University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Knight', 'Affiliation': 'Department of Pediatrics, University of California San Diego, La Jolla, California, USA; Departments of Computer Science and Engineering, University of California San Diego, La Jolla, California, USA; Center for Microbiome Innovation, University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Kosciolek', 'Affiliation': 'Department of Pediatrics, University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Vrbanac', 'Affiliation': 'Department of Pediatrics, University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kotol', 'Affiliation': 'Department of Dermatology, University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Ardeleanu', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hultsch', 'Affiliation': 'Sanofi-Genzyme, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Guttman-Yassky', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bissonnette', 'Affiliation': 'Innovaderm Research, Inc., Montreal, Quebec, Canada.'}, {'ForeName': 'Jonathan I', 'Initials': 'JI', 'LastName': 'Silverberg', 'Affiliation': 'Departments of Dermatology, Preventive Medicine, and Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Krueger', 'Affiliation': 'Laboratory for Investigative Dermatology, Rockefeller University, New York, New York, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Menter', 'Affiliation': 'Department of Dermatology, Baylor University Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Neil M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Pirozzi', 'Affiliation': 'Sanofi, Bridgewater, New Jersey, USA.'}, {'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'Hamilton', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Gallo', 'Affiliation': 'Department of Dermatology, University of California San Diego, La Jolla, California, USA. Electronic address: rgallo@ucsd.edu.'}]",The Journal of investigative dermatology,['10.1016/j.jid.2019.05.024']
368,32299860,The effect of exacerbation history on outcomes in the IMPACT trial.,"IMPACT, a 52-week, randomised, double-blind trial, assessed the efficacy and safety of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy  versus  FF/VI or UMEC/VI in patients with symptomatic COPD and a history of exacerbations.Subgroup analyses assessed whether the efficacy of FF/UMEC/VI  versus  FF/VI or UMEC/VI and UMEC/VI  versus  FF/VI varies according to prior exacerbation history, and the combined effects of exacerbation history and blood eosinophil counts. Three subgroups were defined: single moderate (1 moderate/no severe; n=3056 (30%)), frequent moderate (≥2 moderate/no severe; n=4628 (45%)) and severe (≥1 severe/any moderate; n=2671 (26%)). End-points included annual on-treatment moderate/severe exacerbation rate (pre-specified), lung function and health status (both post-hoc).Moderate/severe exacerbation rates (reduction % (95% CI)) were reduced in the FF/UMEC/VI group  versus  FF/VI (single moderate 20% (10-29), frequent moderate 11% (2-19), severe 17% (7-26)) and  versus  UMEC/VI (single moderate 18% (5-29), frequent moderate 29% (21-37), severe 26% (14-35)). Moderate/severe exacerbation rates were reduced in the FF/VI group  versus  UMEC/VI in the frequent moderate subgroup; a numerical reduction was observed in the severe subgroup (single moderate 2% (-12-18), frequent moderate 21% (11-29), severe 11% (-3-22)). Moderate/severe exacerbation rates were lower in the FF/VI group compared with UMEC/VI in patients with higher eosinophil counts. FF/UMEC/VI improved lung function and health status  versus  both dual therapies irrespective of exacerbation subgroup. UMEC/VI improved lung function  versus  FF/VI in all subgroups.Triple therapy was more effective than dual regardless of exacerbation history, consistent with results in the intent-to-treat population. Comparisons between dual therapies were influenced by prior exacerbation history and eosinophil counts.",2020,Moderate/severe exacerbation rates were reduced in the FF/VI group  versus  UMEC/VI in the frequent moderate subgroup; a numerical reduction was observed in the severe subgroup (single moderate: 2% [-12-18]; frequent moderate: 21% [11-29]; severe: 11% [-3-22]).,"['≥2 moderate/no severe; n=4628 [45%]) and severe (≥1 severe/any moderate; n=2671 [26', 'patients with symptomatic chronic obstructive pulmonary disease and a history of exacerbations']","['fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy  versus  FF/VI or UMEC/VI', 'Triple therapy']","['severe exacerbation rates', 'annual on-treatment moderate/severe exacerbation rate (pre-specified), lung function, and health status ', 'Moderate/severe exacerbation rates', 'UMEC/VI improved lung function', 'efficacy and safety', 'numerical reduction', 'FF/UMEC/VI improved lung function and health status', 'frequent moderate']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}]",,0.597665,Moderate/severe exacerbation rates were reduced in the FF/VI group  versus  UMEC/VI in the frequent moderate subgroup; a numerical reduction was observed in the severe subgroup (single moderate: 2% [-12-18]; frequent moderate: 21% [11-29]; severe: 11% [-3-22]).,"[{'ForeName': 'David M G', 'Initials': 'DMG', 'LastName': 'Halpin', 'Affiliation': 'University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, UK d.halpin@nhs.net.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Dransfield', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, Lung Health Center, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'MeiLan K', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': 'University of Michigan, Pulmonary & Critical Care, Ann Arbor, MI, USA.'}, {'ForeName': 'C Elaine', 'Initials': 'CE', 'LastName': 'Jones', 'Affiliation': 'GlaxoSmithKline, Research Triangle Park, NC, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Kilbride', 'Affiliation': 'GlaxoSmithKline, Stockley Park, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lange', 'Affiliation': 'Medical Dept, Herlev and Gentofte Hospital, Herlev, Denmark.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lomas', 'Affiliation': 'UCL Respiratory, University College London, London, UK.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, NY, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Pascoe', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'University of Manchester, NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Hospitals Trust, Manchester, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wise', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.'}]",The European respiratory journal,['10.1183/13993003.01921-2019']
369,32301579,Cognitive bias modification for threat interpretations: Impact on anxiety symptoms and stress reactivity.,"BACKGROUND


Cognitive bias modification for interpretations (CBM-I) is a computerized intervention that has received increasing attention in the last decade as a potential experimental intervention for anxiety. Initial CBM-I trials with clinical populations suggest the potential utility of this approach. However, most CBM-I experiments have been conducted with unaffected samples, few (one or two) training sessions, and have not examined transfer effects to anxiety-related constructs such as stress reactivity.
METHOD


This study compared a 12-session CBM-I intervention (n = 12) to an interpretation control condition (ICC; n = 12) in individuals (N = 24) with elevated trait anxiety on interpretation bias, anxiety symptom, and stress reactivity outcomes (electrodermal activity, heart rate, and respiratory sinus arrhythmia).
RESULTS


Compared to the ICC group, participants assigned to CBM-I experienced significantly greater improvements in interpretation bias and anxiety symptoms by post-intervention 4 weeks later, with impact on anxiety maintained at 1-month follow-up. While CBM-I and ICC groups did not differ in stress reactivity during an acute stressor at pre-intervention, the CBM-I group evidenced improved stress reactivity at post-intervention compared to ICC on two psychophysiological indices, electrodermal activity and heart rate.
CONCLUSIONS


The results of this pilot study suggest that CBM-I may hold promise for reducing anxiety symptoms, as well as impact psychophysiological arousal during an acute stressor.",2020,"Compared to the ICC group, participants assigned to CBM-I experienced significantly greater improvements in interpretation bias and anxiety symptoms by post-intervention 4 weeks later, with impact on anxiety maintained at 1-month follow-up.",[],"['12-session CBM-I intervention (n\u2009=\u200912) to an interpretation control condition (ICC', 'ICC']","['anxiety symptoms and stress reactivity', 'elevated trait anxiety on interpretation bias, anxiety symptom, and stress reactivity outcomes (electrodermal activity, heart rate, and respiratory sinus arrhythmia', 'stress reactivity', 'psychophysiological indices, electrodermal activity and heart rate', 'interpretation bias and anxiety symptoms', 'anxiety symptoms']",[],"[{'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0003813', 'cui_str': 'Sinus arrhythmia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",24.0,0.0301572,"Compared to the ICC group, participants assigned to CBM-I experienced significantly greater improvements in interpretation bias and anxiety symptoms by post-intervention 4 weeks later, with impact on anxiety maintained at 1-month follow-up.","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Rozenman', 'Affiliation': 'Department of Psychology, University of Denver, Denver, Colorado.'}, {'ForeName': 'Araceli', 'Initials': 'A', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Psychology, California State University, Long Beach, California.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Logan', 'Affiliation': 'Department of Psychology, California State University, Long Beach, California.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Goger', 'Affiliation': 'San Diego State University (SDSU)/University of California, San Diego (UCSD), Joint Doctoral Program in Clinical Psychology, San Diego, California.'}]",Depression and anxiety,['10.1002/da.23018']
370,32298501,High-protein meals require 30% additional insulin to prevent delayed postprandial hyperglycaemia.,"AIM


To determine the amount of additional insulin required for a high-protein meal to prevent postprandial hyperglycaemia in individuals with type 1 diabetes using insulin pump therapy.
METHODS


In this randomized cross-over study, 26 participants aged 8-40 years, HbA 1c  < 65 mmol/mol (8.1%), received a 50 g protein, 30 g carbohydrate, low-fat (< 1 g) breakfast drink over five consecutive days at home. A standard insulin dose (100%) was compared with additional doses of 115, 130, 145 and 160% for the protein, in randomized order. Doses were commenced 15-min pre-drink and delivered over 3 h using a combination bolus with 65% of the standard dose given up front. Postprandial glycaemia was assessed by 4 h of continuous glucose monitoring.
RESULTS


The 100% dosing resulted in postprandial hyperglycaemia. From 120 min, ≥ 130% doses resulted in significantly lower postprandial glycaemic excursions compared with 100% (P < 0.05). A 130% dose produced a mean (sd) glycaemic excursion that was 4.69 (2.42) mmol/l lower than control, returning to baseline by 4 h (P < 0.001). From 120 min, there was a significant increase in the risk of hypoglycaemia compared with control for 145% [odds ratio (OR) 25.4, 95% confidence interval (CI) 5.5-206; P < 0.001) and 160% (OR 103, 95% CI 19.2-993; P < 0.001). Some 81% (n = 21) of participants experienced hypoglycaemia following a 160% dose, whereas 58% (n = 15) experienced hypoglycaemia following a 145% dose. There were no hypoglycaemic events reported with 130%.
CONCLUSIONS


The addition of 30% more insulin to a standard dose for a high-protein meal, delivered using a combination bolus, improves postprandial glycaemia without increasing the risk of hypoglycaemia.",2020,"From 120 min, ≥ 130% doses resulted in significantly lower postprandial glycaemic excursions compared with 100% (P < 0.05).","['26 participants aged 8-40\xa0years, HbA 1c  <\xa065\xa0mmol/mol (8.1%), received a 50\xa0g protein', 'individuals with type 1 diabetes']","['30\xa0g carbohydrate, low-fat (<\xa01\xa0g) breakfast drink']","['risk of hypoglycaemia', 'postprandial hyperglycaemia', 'mean (sd) glycaemic excursion', 'Postprandial glycaemia', 'hypoglycaemia', 'delayed postprandial hyperglycaemia', 'postprandial glycaemic excursions', 'postprandial glycaemia', 'hypoglycaemic events']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0086376', 'cui_str': 'G protein'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C1855520', 'cui_str': 'Postprandial Hyperglycemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",26.0,0.433075,"From 120 min, ≥ 130% doses resulted in significantly lower postprandial glycaemic excursions compared with 100% (P < 0.05).","[{'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Paterson', 'Affiliation': ""Department of Paediatric Endocrinology and Diabetes, John Hunter Children's Hospital, Newcastle, Australia.""}, {'ForeName': 'C E M', 'Initials': 'CEM', 'LastName': 'Smart', 'Affiliation': ""Department of Paediatric Endocrinology and Diabetes, John Hunter Children's Hospital, Newcastle, Australia.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Howley', 'Affiliation': 'School of Mathematical and Physical Sciences/Statistics, The University of Newcastle, Rankin Park, New South Wales, Australia.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Price', 'Affiliation': 'Pacific Private Clinic, Gold Coast, Australia.'}, {'ForeName': 'D C', 'Initials': 'DC', 'LastName': 'Foskett', 'Affiliation': 'Insulin Pump Angels, Gold Coast, Australia.'}, {'ForeName': 'B R', 'Initials': 'BR', 'LastName': 'King', 'Affiliation': ""Department of Paediatric Endocrinology and Diabetes, John Hunter Children's Hospital, Newcastle, Australia.""}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14308']
371,32282882,"IVMP+IVIG raises platelet counts faster than IVIG alone: results of a randomized, blinded trial in childhood ITP.","Children with immune thrombocytopenia (ITP) rarely suffer from life-threatening bleeds (eg, intracranial hemorrhage). In such settings, the combination of IV methylprednisolone (IVMP) with IV immune globulin (IVIG) is used to rapidly increase platelet counts (PCs). However, there are no controlled data to support using combination therapy over IVIG alone. We conducted a randomized, double-blind, placebo-controlled study to evaluate the rapidity of the PC increment and associated adverse events (AEs) between 2 regimens: A (IV placebo) and B (IVMP 30 mg/kg), both given over 1 hour, followed in both cases by IVIG (Gamunex 10%) 1 g/kg over 2-3 hours in children 1-17 years old with primary ITP and PCs <20 × 109/L in whom physicians had decided to treat with IVIG. Thirty-two children (ages: median, 8 years; range, 1.2-17.5 years) with a mean baseline PC of 9.2 × 109/L participated. Eighteen were randomized to regimen A and 14 to regimen B. By 8 hours after initiating therapy, 55% of all children had a PC ≥20 × 109/L (no group difference). By 24 hours, mean PCs were 76.9 × 109/L (B) vs 55 × 109/L (A) (P = .06; P = .035 when adjusted for intergroup differences in patient ages). No patient experienced severe bleeding/unexpected severe AEs. There were statistically fewer IVIG-related headaches in the group receiving combination therapy (P = .046). Our findings show a rapid response to IVIG with/without steroids and provide evidence to support the use of IVMP+IVIG in life-threatening situations. This trial was registered at www.clinicaltrials.gov as #NCT00376077.",2020,There were statistically fewer IVIG-related headaches in the group receiving combination therapy (P = .046).,"['Thirty-two children (ages: median, 8 years; range, 1.2-17.5 years) with a mean baseline PC of 9.2\xa0×', 'children 1-17 years old with primary ITP and PCs <20\xa0×\xa0109/L in whom physicians had decided to treat with IVIG', 'Children with immune thrombocytopenia (ITP) rarely suffer from life-threatening bleeds (eg, intracranial hemorrhage']","['methylprednisolone (IVMP) with IV immune globulin (IVIG', 'IVMP+IVIG', 'placebo']","['platelet counts (PCs', 'rapidity of the PC increment and associated adverse events (AEs', 'IVIG-related headaches', 'severe bleeding/unexpected severe AEs', 'mean PCs']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C5191219', 'cui_str': '9.2'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0242584', 'cui_str': 'Autoimmune thrombocytopenia'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0522498', 'cui_str': 'Rare'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}]","[{'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",32.0,0.385708,There were statistically fewer IVIG-related headaches in the group receiving combination therapy (P = .046).,"[{'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Carcao', 'Affiliation': 'Division of Haematology/Oncology, Department of Paediatrics, Hospital for Sick Children and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Silva', 'Affiliation': 'Kingston General Hospital, Kingston, ON, Canada.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'David', 'Affiliation': 'Pediatric Hematology Oncology, CHU Ste-Justine, University of Montreal, Montreal, QC, Canada.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Klaassen', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Eastern Ontario, Ottawa, ON, Canada.""}, {'ForeName': 'MacGregor', 'Initials': 'M', 'LastName': 'Steele', 'Affiliation': ""Alberta Children's Hospital, Calgary, AB, Canada.""}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Price', 'Affiliation': 'Division of Pediatric Hematology/Oncology, Department of Pediatrics, IWK Health Centre, Halifax, NS, Canada; and.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Wakefield', 'Affiliation': 'Department of Nursing, Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Lussia', 'Initials': 'L', 'LastName': 'Kim', 'Affiliation': 'Child Health Evaluative Sciences, Research Institute, Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Stephens', 'Affiliation': 'Child Health Evaluative Sciences, Research Institute, Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Victor S', 'Initials': 'VS', 'LastName': 'Blanchette', 'Affiliation': 'Division of Haematology/Oncology, Department of Paediatrics, Hospital for Sick Children and University of Toronto, Toronto, ON, Canada.'}]",Blood advances,['10.1182/bloodadvances.2019001343']
372,32282696,Hemorrhoidal artery ligation with Doppler guidance vs digital guidance for grade II-III hemorrhoidal disease treatment: Study protocol clinical trial (SPIRIT Compliant).,"INTRODUCTION


Hemorrhoidal artery ligation (HAL) with Doppler guidance and suture fixation of hemorrhoidal nodes (RAR) is a popular minimally invasive technique for hemorrhoidal disease (HD) treatment which uses an ultrasound probe to detect hemorrhoidal arteries for further ligation. We hypothesized that ultrasound guidance has no advantages over manual hemorrhoidal arteries detection for HD treatment.The aim is to compare the results of HAL-RAR procedure in patients with stage II-III HD with Doppler and manual HA detection.In this ongoing randomized, controlled, single center clinical study 204 patients randomly divides into group A (HAL-RAR with Doppler US navigation) and group B (HAL with manual HA detection and mucopexy) are planned to be included. The primary endpoint was recurrence of any symptoms of HD; secondary endpoints were pain syndrome severity, treatment satisfaction (1 to 5 points), and need for the drug therapy in 30 days and 8 weeks after surgery.
CONCLUSION


Ultrasound guidance technology of HAL with mucopexy could have the same efficacy the manual HA detection regarding the HD treatment effectiveness and patient satisfaction.",2020,(RAR) is a popular minimally invasive technique for hemorrhoidal disease (HD) treatment which uses an ultrasound probe to detect hemorrhoidal arteries for further ligation.,"['204 patients randomly', 'patients with stage II-III HD with Doppler and manual HA detection', 'grade II-III hemorrhoidal disease treatment']","['HAL-RAR procedure', 'Hemorrhoidal artery ligation with Doppler guidance vs digital guidance', 'divides into group A (HAL-RAR with Doppler US navigation) and group B (HAL with manual HA detection and mucopexy', 'Hemorrhoidal artery ligation (HAL) with Doppler guidance and suture fixation of hemorrhoidal nodes', 'ultrasound guidance']","['recurrence of any symptoms of HD', 'pain syndrome severity, treatment satisfaction (1 to 5 points), and need for the drug therapy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0034896', 'cui_str': 'Rectum structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0034896', 'cui_str': 'Rectum structure'}, {'cui': 'C0189722', 'cui_str': 'Ligation of artery'}, {'cui': 'C0140278', 'cui_str': 'Retinoic Acid Receptor'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034896', 'cui_str': 'Rectum structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0391976', 'cui_str': 'Pain Disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",204.0,0.0325255,(RAR) is a popular minimally invasive technique for hemorrhoidal disease (HD) treatment which uses an ultrasound probe to detect hemorrhoidal arteries for further ligation.,"[{'ForeName': 'Daniil', 'Initials': 'D', 'LastName': 'Markaryan', 'Affiliation': 'Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University), Moscow, Russia.'}, {'ForeName': 'Inna', 'Initials': 'I', 'LastName': 'Tulina', 'Affiliation': ''}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Garmanova', 'Affiliation': ''}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Bredikhin', 'Affiliation': ''}, {'ForeName': 'Aftandil', 'Initials': 'A', 'LastName': 'Alikperzade', 'Affiliation': ''}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Tsarkov', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000019424']
373,32304353,Effectiveness of Zhong-Yong thinking based dialectical behavior therapy group skills training versus supportive group therapy for lowering suicidal risks in Chinese young adults: A randomized controlled trial with a 6-month follow-up.,"BACKGROUND


Dialectical behavior therapy (DBT) is a first-line treatment for the prevention of suicide. Zhong-Yong thinking could be viewed as a Chinese way of dialectical thinking, has long been a culturally dictating thinking style in China. To enhance cultural adaptability, we integrated Zhong-Yong thinking into DBT group skills training and examined its efficacy in suicidal prevention compared with a supportive group therapy and a wait-list group in high-risk suicidal Chinese college students.
METHODS


A total of 97 suicidal participants were randomized to either Zhong-Yong thinking based DBT group skills training (DBT ZYT  , n = 33), or supportive group therapy (SGT; n = 32), or wait-list group (WL; n = 32). DBT ZYT  was a 12-week program based on Zhong-Yong thinking instead of dialectical thinking, coaching participants mindfulness, emotion regulation, distress tolerance, and interpersonal effectiveness. Supportive group therapy was a 12-week program aiming at improving interpersonal effectiveness and emotion regulation skills. Outcome measures were assessed at pre- and post-treatment and 6-month follow-up.
RESULTS


At post-treatment measures, the levels of suicidal ideation, hopelessness, psychache symptoms, and general psychopathology had significantly decreased in both intervention groups; at the 6-month follow-up measures, the intervention effects were better maintained in the DBT ZYT  group rather than in the SGT group. Specifically, DBT ZYT  was more effective in relieving participants' long-term obsessive-compulsive, anxiety, hostility, phobic, psychotic, and additional symptoms.
CONCLUSIONS


Zhong-Yong thinking not only could integrate with DBT skills training in Chinese young adult population, but also has special strength in enhancing DBT's efficacy.",2020,"At post-treatment measures, the levels of suicidal ideation, hopelessness, psychache symptoms, and general psychopathology had significantly decreased in both intervention groups; at the 6-month follow-up measures, the intervention effects were better maintained in the DBT ZYT  group rather than in the SGT group.","['high-risk suicidal Chinese college students', 'Chinese young adults', '97 suicidal participants', 'Chinese young adult population']","['Zhong-Yong thinking based dialectical behavior therapy group skills training versus supportive group therapy', 'Zhong-Yong thinking based DBT group skills training (DBT ZYT  , n\xa0=\xa033), or supportive group therapy (SGT; n\xa0=\xa032), or wait-list', 'Supportive group therapy', 'Dialectical behavior therapy (DBT', 'DBT skills training']","['levels of suicidal ideation, hopelessness, psychache symptoms, and general psychopathology', ""relieving participants' long-term obsessive-compulsive, anxiety, hostility, phobic, psychotic, and additional symptoms"", 'emotion regulation, distress tolerance, and interpersonal effectiveness', 'suicidal risks', 'interpersonal effectiveness and emotion regulation skills']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1321145', 'cui_str': 'Dialectical behavior therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C4521535', 'cui_str': 'US Military enlisted E5'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0150041', 'cui_str': 'Feeling hopeless'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0020039', 'cui_str': 'Hostile behavior'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",97.0,0.0292573,"At post-treatment measures, the levels of suicidal ideation, hopelessness, psychache symptoms, and general psychopathology had significantly decreased in both intervention groups; at the 6-month follow-up measures, the intervention effects were better maintained in the DBT ZYT  group rather than in the SGT group.","[{'ForeName': 'Xueling', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Psychology, Guangdong Provincial Key Laboratory of Tropical Disease Research, School of Public Health, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Psychology, Guangdong Provincial Key Laboratory of Tropical Disease Research, School of Public Health, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Psychology, Guangdong Provincial Key Laboratory of Tropical Disease Research, School of Public Health, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'School of Nursing, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Weichen', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'School of Nursing, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Caiyan', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Department of Psychology, Guangdong Provincial Key Laboratory of Tropical Disease Research, School of Public Health, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Peining', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychology, Guangdong Provincial Key Laboratory of Tropical Disease Research, School of Public Health, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Siyuan', 'Initials': 'S', 'LastName': 'Ding', 'Affiliation': 'Department of Psychology, Guangdong Provincial Key Laboratory of Tropical Disease Research, School of Public Health, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Xiaoyuan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychology, Guangdong Provincial Key Laboratory of Tropical Disease Research, School of Public Health, Southern Medical University, Guangzhou, China.'}]",Brain and behavior,['10.1002/brb3.1621']
374,32303894,The Physiological Regulation of Emotion During Social Interactions: Vagal Flexibility Moderates the Effects of a Military Parenting Intervention on Father Involvement in a Randomized Trial.,"To make prevention programs more effective and understand ""what works for whom,"" evidence regarding what individual characteristics predict intervention responsiveness is needed. Previous studies have evaluated a military parent training program known as After Deployment Adaptive Parenting Tools/ADAPT, yet less is understood about the program's varying effects for fathers. We tested the physiological regulation of emotion during social interactions as a moderator predicting fathers' responsiveness in a randomized trial of ADAPT, in which emotion regulation was operationally measured through vagal flexibility (VF; dynamic changes in cardiac vagal tone). Families with a child aged between 4 and 13 years for whom physiological data were gathered (n = 145) were randomly assigned to ADAPT (14-week face-to-face group intervention) or a control group (services as usual). Fathers in these families were National Guard/Reserve members who had been deployed to war in Iraq and/or Afghanistan and recently returned. Prior to the intervention, cardiac data was collected in-home throughout a set of family interaction tasks and VF was operationalized as the changes in high frequency (HF) power of heart rate variability (HRV) from a reading task to a problem-solving task. Parenting behaviors were observed and coded based on theory-driven indicators pre-intervention and at 1-year follow-up. Results of structural equation modeling showed that VF significantly moderated fathers' intervention responsiveness, such that fathers with higher vs. lower VF exhibited more effective parenting at 1-year follow-up if they were randomized into ADAPT vs. the control group. This study is the first to demonstrate that parasympathetic vagal functioning may be a biomarker to predict response to a military parenting intervention to enhance parenting in combat deployed fathers. The implications for precision-based prevention are discussed.",2020,"Results of structural equation modeling showed that VF significantly moderated fathers' intervention responsiveness, such that fathers with higher vs. lower VF exhibited more effective parenting at 1-year follow-up if they were randomized into ADAPT vs. the control group.","['Emotion During Social Interactions', 'Families with a child aged between 4 and 13\xa0years for whom physiological data were gathered (n\u2009=\u2009145', 'Fathers in these families were National Guard/Reserve members who had been deployed to war in Iraq and/or Afghanistan and recently returned']","['Military Parenting Intervention', 'military parenting intervention', 'ADAPT (14-week face-to-face group intervention) or a control group (services as usual']","['Parenting behaviors', 'vagal flexibility (VF; dynamic changes in cardiac vagal tone']","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0037420', 'cui_str': 'Interaction with others'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0278253', 'cui_str': 'Guarded prognosis'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0043027', 'cui_str': 'War'}, {'cui': 'C0022066', 'cui_str': 'Iraq'}, {'cui': 'C0001732', 'cui_str': 'Afghanistan'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0332156', 'cui_str': 'Return to'}]","[{'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]",145.0,0.0230976,"Results of structural equation modeling showed that VF significantly moderated fathers' intervention responsiveness, such that fathers with higher vs. lower VF exhibited more effective parenting at 1-year follow-up if they were randomized into ADAPT vs. the control group.","[{'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'REACH Institute, Department of Psychology, Arizona State University, 900 S. McAllister, Psychology North, Rm 212, Tempe, AZ, 85287, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hoch', 'Affiliation': 'Department of Educational Psychology, University of Minnesota-Twin Cities, 250 Education Sciences Bldg, 56 East River Rd, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Abigail H', 'Initials': 'AH', 'LastName': 'Gewirtz', 'Affiliation': 'Department of Family Social Science and Institute of Child Development, University of Minnesota-Twin Cities, 290 McNeal Hall, 1985 Buford Ave, St. Paul, MN, 55108, USA. agewirtz@umn.edu.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01122-6']
375,32304159,Evaluation of an implementation project: The exercise physiology in aged care program.,"AIM


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


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


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


Data supporting the maintenance for some physical functions suggest that this type of program should be considered for older adults living with dementia in residential aged care facilities. Geriatr Gerontol Int 2020; ••: ••-••.",2020,Evidence for a dose effect was demonstrated for the 2-min walk and timed-up-and-go associated with the number of individual sessions attended by a participant.,"['Participants (n = 59', 'vulnerable older adults living with dementia, delivered in a residential aged care facility in South Australia', 'older adults', 'In total, 51 family members and 44 care staff completed surveys or participated', 'older adults living with dementia in residential aged care facilities', 'aged care program']",['Exercise Physiologist-led exercise program'],"['Physical function, cognitive function and habitual physical activity', 'handgrip strength', 'habitual activity or cognitive function', 'maintenance of physical function']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C0037715', 'cui_str': 'South Australia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0260141', 'cui_str': 'Physiologist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",59.0,0.0232159,Evidence for a dose effect was demonstrated for the 2-min walk and timed-up-and-go associated with the number of individual sessions attended by a participant.,"[{'ForeName': 'Gaynor', 'Initials': 'G', 'LastName': 'Parfitt', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity (ARENA), University of South Australia Allied Health and Human Performance, Adelaide, South Australia, Australia.'}, {'ForeName': 'Dannielle', 'Initials': 'D', 'LastName': 'Post', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity (ARENA), University of South Australia Allied Health and Human Performance, Adelaide, South Australia, Australia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Penington', 'Affiliation': 'Helping Hand Organisation, North Adelaide, South Australia, Australia.'}, {'ForeName': 'Kade', 'Initials': 'K', 'LastName': 'Davison', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity (ARENA), University of South Australia Allied Health and Human Performance, Adelaide, South Australia, Australia.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Corlis', 'Affiliation': 'Helping Hand Organisation, North Adelaide, South Australia, Australia.'}]",Geriatrics & gerontology international,['10.1111/ggi.13923']
376,32298131,Bridge-Enhanced Anterior Cruciate Ligament Repair Is Not Inferior to Autograft Anterior Cruciate Ligament Reconstruction at 2 Years: Results of a Prospective Randomized Clinical Trial.,"BACKGROUND


Preclinical studies suggest that for complete midsubstance anterior cruciate ligament (ACL) injuries, a suture repair of the ACL augmented with a protein implant placed in the gap between the torn ends (bridge-enhanced ACL repair [BEAR]) may be a viable alternative to ACL reconstruction (ACLR).
HYPOTHESIS


We hypothesized that patients treated with BEAR would have a noninferior patient-reported outcomes (International Knee Documentation Committee [IKDC] Subjective Score; prespecified noninferiority margin, -11.5 points) and instrumented anteroposterior (AP) knee laxity (prespecified noninferiority margin, +2-mm side-to-side difference) and superior muscle strength at 2 years after surgery when compared with patients who underwent ACLR with autograft.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 1.
METHODS


One hundred patients (median age, 17 years; median preoperative Marx activity score, 16) with complete midsubstance ACL injuries were enrolled and underwent surgery within 45 days of injury. Patients were randomly assigned to receive either BEAR (n = 65) or autograft ACLR (n = 35 [33 with quadrupled semitendinosus-gracilis and 2 with bone-patellar tendon-bone]). Outcomes-including the IKDC Subjective Score, the side-to-side difference in instrumented AP knee laxity, and muscle strength-were assessed at 2 years by an independent examiner blinded to the procedure. Patients were unblinded after their 2-year visit.
RESULTS


In total, 96% of the patients returned for 2-year follow-up. Noninferiority criteria were met for both the IKDC Subjective Score (BEAR, 88.9 points; ACLR, 84.8 points; mean difference, 4.1 points [95% CI, -1.5 to 9.7]) and the side-to-side difference in AP knee laxity (BEAR, 1.61 mm; ACLR, 1.77 mm; mean difference, -0.15 mm [95% CI, -1.48 to 1.17]). The BEAR group had a significantly higher mean hamstring muscle strength index than the ACLR group at 2 years (98.2% vs 63.2%;  P  < .001). In addition, 14% of the BEAR group and 6% of the ACLR group had a reinjury that required a second ipsilateral ACL surgical procedure ( P  = .32). Furthermore, the 8 patients who converted from BEAR to ACLR in the study period and returned for the 2-year postoperative visit had similar primary outcomes to patients who had a single ipsilateral ACL procedure.
CONCLUSION


BEAR resulted in noninferior patient-reported outcomes and AP knee laxity and superior hamstring muscle strength when compared with autograft ACLR at 2-year follow-up in a young and active cohort. These promising results suggest that longer-term studies of this technique are justified.
REGISTRATION


NCT02664545 (ClinicalTrials.gov identifier).",2020,The BEAR group had a significantly higher mean hamstring muscle strength index than the ACLR group at 2 years (98.2% vs 63.2%;  P  < .001).,"['One hundred patients (median age, 17 years; median preoperative Marx activity score, 16) with complete midsubstance ACL injuries were enrolled and underwent surgery within 45 days of injury', 'Autograft Anterior Cruciate Ligament Reconstruction at 2 Years', 'complete midsubstance anterior cruciate ligament (ACL) injuries']","['autograft ACLR', 'BEAR', 'ACLR', 'Bridge-Enhanced Anterior Cruciate Ligament Repair', 'ACLR with autograft']","['IKDC Subjective Score', 'AP knee laxity', 'IKDC Subjective Score, the side-to-side difference in instrumented AP knee laxity, and muscle strength', 'AP knee laxity and superior hamstring muscle strength', 'mean hamstring muscle strength index']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1456574', 'cui_str': 'Injury of anterior cruciate ligament'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}]","[{'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0332536', 'cui_str': 'Laxity'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",100.0,0.170288,The BEAR group had a significantly higher mean hamstring muscle strength index than the ACLR group at 2 years (98.2% vs 63.2%;  P  < .001).,"[{'ForeName': 'Martha M', 'Initials': 'MM', 'LastName': 'Murray', 'Affiliation': ""Investigation performed at Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Braden C', 'Initials': 'BC', 'LastName': 'Fleming', 'Affiliation': ""Investigation performed at Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Badger', 'Affiliation': ""Investigation performed at Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ""Investigation performed at Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Freiberger', 'Affiliation': ""Investigation performed at Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Henderson', 'Affiliation': ""Investigation performed at Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Barnett', 'Affiliation': ""Investigation performed at Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Ata', 'Initials': 'A', 'LastName': 'Kiapour', 'Affiliation': ""Investigation performed at Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Ecklund', 'Affiliation': ""Investigation performed at Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Proffen', 'Affiliation': ""Investigation performed at Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Sant', 'Affiliation': ""Investigation performed at Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Dennis E', 'Initials': 'DE', 'LastName': 'Kramer', 'Affiliation': ""Investigation performed at Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Lyle J', 'Initials': 'LJ', 'LastName': 'Micheli', 'Affiliation': ""Investigation performed at Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Yi-Meng', 'Initials': 'YM', 'LastName': 'Yen', 'Affiliation': ""Investigation performed at Boston Children's Hospital, Boston, Massachusetts, USA.""}]",The American journal of sports medicine,['10.1177/0363546520913532']
377,32299820,Low-dose versus High-dose Carfilzomib with Dexamethasone (S1304) in Patients with Relapsed-Refractory Multiple Myeloma.,"PURPOSE


Treatment of multiple myeloma has evolved tremendously and optimal utilization of available therapies will ensure maximal patient benefits.
PATIENTS AND METHODS


We report the Southwest Oncology Group randomized phase II trial (S1304) comparing twice weekly low-dose (27 mg/m 2 ; arm 1) to high-dose carfilzomib (56 mg/m 2 ; arm 2), both with dexamethasone, administered for 12 cycles (11 months) for relapsed and/or refractory multiple myeloma with up to six prior lines of therapy (NCT01903811). The primary endpoint was progression-free survival (PFS), and patients on arm 1 could cross-over to arm 2 after progression on treatment.
RESULTS


Among 143 enrolled patients, of whom 121 were eligible and analyzable, the overall response rate was 42.8%, with no significant difference between the arms ( P  = 0.113). Also, neither the median PFS [5 months and 8 months, respectively; HR, 1.061; 80% Wald confidence interval (CI), 0.821-1.370;  P  = 0.384] nor the median overall survival were significantly different (26 and 22 months, respectively; HR, 1.149, 80% Wald CI, 0.841-.571;  P  = 0.284). Sixteen patients crossed over to arm 2 with a median PFS benefit of 3 months. Certain adverse events (AE) were more frequent in arm 2, including fatigue, thrombocytopenia, and peripheral neuropathy, but there was no significant difference in cardiopulmonary AEs.
CONCLUSIONS


This randomized trial did not support a benefit of fixed duration, twice weekly 56 mg/m 2  dosing of carfilzomib over the 27 mg/m 2  dose for the treatment of relapsed and/or refractory multiple myeloma. However, treatment to progression in earlier patient populations with high-dose carfilzomib using different schedules should still be considered as part of the standard of care.",2020,"Certain adverse events (AE) were more frequent in Arm 2, including fatigue, thrombocytopenia and peripheral neuropathy, but there was no significant difference in cardiopulmonary AEs.
","['multiple myeloma (MM', '143 enrolled patients', 'Patients with Relapsed-Refractory Multiple Myeloma']","['dexamethasone', 'carfilzomib', 'Dexamethasone']","['fatigue, thrombocytopenia and peripheral neuropathy', 'cardiopulmonary AEs', 'median overall survival', 'Certain adverse events (AE', 'overall response rate', 'progression-free survival (PFS', 'median PFS']","[{'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2001856', 'cui_str': 'carfilzomib'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",143.0,0.0870112,"Certain adverse events (AE) were more frequent in Arm 2, including fatigue, thrombocytopenia and peripheral neuropathy, but there was no significant difference in cardiopulmonary AEs.
","[{'ForeName': 'Sikander', 'Initials': 'S', 'LastName': 'Ailawadhi', 'Affiliation': 'Mayo Clinic, Jacksonville, Florida. ailawadhi.sikander@mayo.edu.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Sexton', 'Affiliation': 'Cancer Research and Biostatistics, Seattle, Washington.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Lentzsch', 'Affiliation': 'Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Muneer H', 'Initials': 'MH', 'LastName': 'Abidi', 'Affiliation': 'Spectrum Health/Michigan State University, Grand Rapids, Michigan.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Voorhees', 'Affiliation': 'Levine Cancer Institute, Charlotte, North Carolina.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'Cohen', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Rohren', 'Affiliation': 'Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Heitner', 'Affiliation': 'Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Kelly', 'Affiliation': 'Norris Comprehensive Cancer Center, Los Angeles, California.'}, {'ForeName': 'Niklas J', 'Initials': 'NJ', 'LastName': 'Mackler', 'Affiliation': 'IHA Hem/Onc, Ann Arbor, Michigan.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Baer', 'Affiliation': 'Kaiser Permanente, Oakland, California.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Hoering', 'Affiliation': 'Cancer Research and Biostatistics, Seattle, Washington.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Durie', 'Affiliation': 'Cedars-Sinai Comprehensive Cancer Center, Los Angeles, California.'}, {'ForeName': 'Robert Z', 'Initials': 'RZ', 'LastName': 'Orlowski', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-1997']
378,31401457,On EMDR: Measuring the working memory taxation of various types of eye (non-)movement conditions.,"BACKGROUND AND OBJECTIVE


A recent, large randomized controlled trial employing different forms of eye (non-)movements in eye movement desensitization and reprocessing (EMDR) showed that fixating the eyes either on a therapist's moving or non-moving hand led to equal reductions in symptoms of post-traumatic stress disorder (PTSD). However, numerous EMDR lab analogue studies found that eye movements produce larger memory effects than eyes stationary. These beneficial effects are typically explained by differences in working memory (WM) taxation. We tested the degree of WM taxation of several eye (non-)movement conditions used in the clinical trial.
METHODS


All participants (N = 40) performed: (1) eyes moving by following the experimenter's moving finger, (2) eyes fixed on the experimenter's stationary finger, (3) eyes closed, or (4) looking unfocused into the room. Simultaneously they performed a simple reaction time task. Reaction times are an objective index of the extent to which different dual attention tasks tax WM.
RESULTS


Eyes moving is more taxing than eyes fixed, while eyes fixed did not differ from eyes unfocused. All conditions were more taxing than eyes closed.
LIMITATIONS


We studied WM taxation in a laboratory setting; no clinical interventions were applied.
CONCLUSIONS


In line with previous lab studies, making eye movements was more taxing than eyes fixed. We discuss why this effect was not observed for reductions in PTSD symptoms in the clinical trial (e.g., differences in dependent variables, sample population, and intervention duration). For more comprehensive future insights, we recommend integration of mechanistically focused lab analogue studies and patient-oriented clinical studies.",2019,"RESULTS


Eyes moving is more taxing than eyes fixed, while eyes fixed did not differ from eyes unfocused.",[],"[""eyes moving by following the experimenter's moving finger, (2) eyes fixed on the experimenter's stationary finger, (3) eyes closed, or (4) looking unfocused into the room"", 'eye (non-)movements in eye movement desensitization and reprocessing (EMDR']","['PTSD symptoms', 'working memory (WM) taxation']",[],"[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0578671', 'cui_str': 'Does move (finding)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0016129', 'cui_str': 'Fingers'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0439835', 'cui_str': 'Stationary (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0556520', 'cui_str': 'Desensitization (Psychology)'}, {'cui': 'C0870535', 'cui_str': 'EMDR'}]","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0039370', 'cui_str': 'Taxation'}]",,0.0714934,"RESULTS


Eyes moving is more taxing than eyes fixed, while eyes fixed did not differ from eyes unfocused.","[{'ForeName': 'Suzanne C', 'Initials': 'SC', 'LastName': 'van Veen', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, the Netherlands. Electronic address: s.c.vanveen@uu.nl.'}, {'ForeName': 'Sahaj', 'Initials': 'S', 'LastName': 'Kang', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'van Schie', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus University Rotterdam, the Netherlands.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2019.101494']
379,31469508,Effect of multidose drug dispensing on the time in therapeutic range in patients using vitamin-K antagonists: A randomized controlled trial.,"BACKGROUND


A high number of vitamin K antagonist (VKA) users have a low proportion of time in therapeutic range (TTR) resulting in a high number of bleeding and thromboembolism events.
OBJECTIVE


Can the quality of anticoagulation be improved by dispensing VKAs via multidose drug dispensing (MDD).
METHOD


A randomized controlled trial in the Netherlands. Patients who used VKAs, ≥65 years of age with a TTR <65% were eligible for inclusion. All oral drugs were dispensed via MDD. In MDD systems, all oral chronic medication intended for one dosing moment is packed in plastic disposable pouches. Controls received VKAs by manual dispensing. The difference in TTR between the 6 months after- and 6 months before the index date. A mixed-effects model with the intervention, TTR before the index date, MDD system at baseline as covariates, and pharmacy as random effect. A per-protocol analysis was performed with all patients who completed the study as intended.
RESULTS


One hundred and seventy-nine patients were included. Mean age was 80.0 (SD 6.9) years. Mean TTR during the study was 79.2 ± 18.0% in the intervention group and 72.5 ± 20.1% in the control group. The intervention resulted in a 5.6% (95% CI: 0.1-11.1) increase in TTR compared to the control group. Per-protocol analysis resulted in an 8.3% (95% CI: 0.99-15.61) increase in TTR compared to the control group. No differences in reduction were observed between the intervention and control group.
CONCLUSION


The quality of anticoagulation can be improved with the use of MDD systems.",2020,"No differences in reduction were observed between the intervention and control group.
","['Mean age was 80.0 (SD 6.9) years', '179 patients were included', 'Patients who used VKAs, ≥ 65 years of age with a time in therapeutic range < 65% were eligible for inclusion', 'patients using vitamin-K antagonists']","['vitamin K antagonists (VKAs', 'multidose drug dispensing']","['Mean TTR', 'time in therapeutic range (TTR', 'TTR', 'quality of anticoagulation']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517609', 'cui_str': '179 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C3653316', 'cui_str': 'Vitamin K antagonists'}]","[{'cui': 'C3653316', 'cui_str': 'Vitamin K antagonists'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",179.0,0.106827,"No differences in reduction were observed between the intervention and control group.
","[{'ForeName': 'Bram J', 'Initials': 'BJ', 'LastName': 'Mertens', 'Affiliation': 'SIR Institute for Pharmacy Practice and Policy, Leiden, the Netherlands.'}, {'ForeName': 'Henk-Frans', 'Initials': 'HF', 'LastName': 'Kwint', 'Affiliation': 'SIR Institute for Pharmacy Practice and Policy, Leiden, the Netherlands.'}, {'ForeName': 'Svetlana V', 'Initials': 'SV', 'LastName': 'Belitser', 'Affiliation': 'Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, University Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Felix J M', 'Initials': 'FJM', 'LastName': 'van der Meer', 'Affiliation': 'Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Rob J', 'Initials': 'RJ', 'LastName': 'van Marum', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Marcel L', 'Initials': 'ML', 'LastName': 'Bouvy', 'Affiliation': 'SIR Institute for Pharmacy Practice and Policy, Leiden, the Netherlands.'}]",Journal of thrombosis and haemostasis : JTH,['10.1111/jth.14625']
380,30857773,A Randomized Trial of Baby Triple P for Preterm Infants: Child Outcomes at 2 Years of Corrected Age.,"OBJECTIVE


To determine the efficacy of a hospital-based intervention that transitions into existing community support, in enhancing developmental outcomes at 2 years of corrected age in infants born at less than 32 weeks.
STUDY DESIGN


In total, 323 families of 384 infants born <32 weeks were randomized to receive intervention or care-as-usual. The intervention teaches parents coping skills, partner support, and effective parenting strategies over 4 hospital-based and 4 home-phone sessions. At 2 years of corrected age maternally reported child behavior was assessed by the Infant and Toddler Social Emotional Adjustment Scale. Observed child behavior was coded with the Revised Family Observation Schedule. Cognitive, language, and motor skills were assessed with the Bayley Scales of Infant and Toddler Development III.
RESULTS


Mean gestational age of infants was 28.5 weeks (SD = 2.1), and mothers' mean age was 30.6 years (SD = 5.8). A total of 162 families (n = 196 infants) were allocated to intervention and 161 families (n = 188 infants) received care-as-usual. There was no significant adjusted difference between treatment groups on dysregulation (0.2; 95% CI -2.5 to 3.0, P = .9) externalizing (0.3; 95% CI -1.6 to 2.2, P = .8), internalizing (-1.5; 95% CI -4.3 to 1.3, P = .3), observed aversive (0.00; -0.04 to 0.04, P = .9), or nonaversive behavior (-0.01; 95% CI -0.05 to 0.03, P = .7). Intervention children scored significantly higher on cognition (3.5; 95% CI 0.2-6.8, P = .04) and motor skill (5.5; 95% CI 2.5-8.4, P < .001), and approached significance on language (3.8; 95% CI -0.3 to 7.9, P = .07).
CONCLUSIONS


Baby Triple P for Preterm Infants increases cognitive and motor skills but does not impact behavior. The results are evidence that hospital-based interventions can improve some developmental outcomes for infants <32 weeks.
TRIAL REGISTRATION


ACTRN 12612000194864.",2019,"externalizing (0.3; 95% CI -1.6 to 2.2, P = .8), internalizing (-1.5; 95% CI -4.3 to 1.3, P = .3)","['In total, 323 families of 384 infants born <32\xa0weeks', ""Mean gestational age of infants was 28.5\xa0weeks (SD\xa0=\xa02.1), and mothers' mean age was 30.6\xa0years (SD\xa0=\xa05.8"", 'A total of 162 families (n\xa0=\xa0196 infants', '2\xa0years of corrected age in infants born at less than 32\xa0weeks', 'Preterm Infants']","['care-as-usual', 'Baby Triple P', 'intervention or care-as-usual']","['Bayley Scales of Infant and Toddler Development III', 'child behavior', 'externalizing', 'Cognitive, language, and motor skills', 'nonaversive behavior', 'cognition', 'motor skill', 'cognitive and motor skills', 'Infant and Toddler Social Emotional Adjustment Scale']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C4517678', 'cui_str': '28.5'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}]","[{'cui': 'C0222045'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0557904', 'cui_str': 'Psychological Adjustment'}]",162.0,0.145524,"externalizing (0.3; 95% CI -1.6 to 2.2, P = .8), internalizing (-1.5; 95% CI -4.3 to 1.3, P = .3)","[{'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Colditz', 'Affiliation': ""University of Queensland Center for Clinical Research, Faculty of Medicine, The University of Queensland, Brisbane, Australia; Royal Brisbane and Women's Hospital, Brisbane, Australia. Electronic address: p.colditz@uq.edu.au.""}, {'ForeName': 'Roslyn N', 'Initials': 'RN', 'LastName': 'Boyd', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Center, UQ Child Health Research Center, Faculty of Medicine, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Winter', 'Affiliation': 'University of Queensland Center for Clinical Research, Faculty of Medicine, The University of Queensland, Brisbane, Australia; The Parenting and Family Support Center, School of Psychology, Faculty of Health and Behavioral Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Margo', 'Initials': 'M', 'LastName': 'Pritchard', 'Affiliation': ""University of Queensland Center for Clinical Research, Faculty of Medicine, The University of Queensland, Brisbane, Australia; Mater Mothers' Hospital, Brisbane, Australia; Australian Catholic University, Brisbane, Australia.""}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Gray', 'Affiliation': ""Mater Mothers' Hospital, Brisbane, Australia; Mater Research Institute-University of Queensland, Brisbane, Australia.""}, {'ForeName': 'Koa', 'Initials': 'K', 'LastName': 'Whittingham', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Center, UQ Child Health Research Center, Faculty of Medicine, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': ""O'Callaghan"", 'Affiliation': ""Mater Mothers' Hospital, Brisbane, Australia.""}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Jardine', 'Affiliation': ""Mater Mothers' Hospital, Brisbane, Australia; Mater Research Institute-University of Queensland, Brisbane, Australia.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': ""O'Rourke"", 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Marquart', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Kylee', 'Initials': 'K', 'LastName': 'Forrest', 'Affiliation': 'University of Queensland Center for Clinical Research, Faculty of Medicine, The University of Queensland, Brisbane, Australia; Mater Research Institute-University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Spry', 'Affiliation': 'The Parenting and Family Support Center, School of Psychology, Faculty of Health and Behavioral Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Sanders', 'Affiliation': 'The Parenting and Family Support Center, School of Psychology, Faculty of Health and Behavioral Sciences, The University of Queensland, Brisbane, Australia.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.01.024']
381,32304248,Soft tissue stability around dental implants after soft tissue grafting from the lateral palate or the tuberosity area - A randomized controlled clinical study.,"AIM


To compare the soft tissue stability (STA) around single implants previously augmented with either subepithelial connective tissue graft (SCTG) from the lateral palate (LP) or from the tuberosity area (TA).
MATERIAL AND METHODS


Twenty-nine patients showing 33 implants with buccal volume deficiency randomly received SCTG from LP (control group/CG) or TA (test group/TG). At 4 months (FU-4) the definitive crown was installed and an intra-oral scan performed. At 12 months (FU-12), a new scan was registered. Between FU-4 and FU-12 STA was evaluated by STL image superimposition. Clinical parameters and the modified pink aesthetic score (PES) (Fürhauser et al. 2005) were recorded.
RESULTS


After FU-4 both tissues demonstrated a similar STA without statistically significant differences (SSD). The mean soft tissue changes were 0.03 ± 0.22 mm for CG and 0.04 ± 0.23 mm for TG (p = .870). SSD were observed for changes in keratinized tissue (KT) with greater stability for TG (0 ± 0.32 mm) compared with CG (-0.3 ± 0.33 mm) (p = .002). PES resulted in mean values of 8.37 ± 2.46 for CG and 8.54 ± 2.43 for TG (p=.59).
CONCLUSIONS


Both groups demonstrated similar STA between the definitive crown placement and 12 months, while greater stability of the KT gained was observed in TG.",2020,"Both groups demonstrated similar STA between the definitive crown placement and 12 months, while greater stability of the KT gained was observed in TG.",['Twenty-nine patients showing 33 implants with buccal volume deficiency randomly received'],"['FU-4', 'subepithelial connective tissue graft (SCTG', 'SCTG from LP (control group/CG) or TA (test group/TG', 'soft tissue stability (STA']","['stability of the KT gained', 'mean soft tissue changes', 'Soft tissue stability', 'SSD', 'modified pink aesthetic score (PES']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}]","[{'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332585', 'cui_str': 'Pink color'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",29.0,0.0325745,"Both groups demonstrated similar STA between the definitive crown placement and 12 months, while greater stability of the KT gained was observed in TG.","[{'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Rojo', 'Affiliation': 'Department of Periodontology, Universitat Internacional de Catalunya (UIC), Barcelona, Spain.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Stroppa', 'Affiliation': 'Department of Periodontology, Universitat Internacional de Catalunya (UIC), Barcelona, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Sanz-Martin', 'Affiliation': 'Department of Periodontology, Universitat Internacional de Catalunya (UIC), Barcelona, Spain.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Gonzalez-Martín', 'Affiliation': 'Section of Post-graduate Periodontology, Faculty of Odontology, University Complutense of Madrid, Madrid, Spain.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Nart', 'Affiliation': 'Department of Periodontology, Universitat Internacional de Catalunya (UIC), Barcelona, Spain.'}]",Journal of clinical periodontology,['10.1111/jcpe.13292']
382,31603721,Positive Effect of Platelet-Rich Plasma on Pain in Plantar Fasciitis: A Double-Blind Multicenter Randomized Controlled Trial.,"BACKGROUND


When nonoperative treatment for chronic plantar fasciitis fails, often a corticosteroid injection is given. Corticosteroid injection gives temporary pain reduction but no healing. Platelet-rich plasma (PRP) has proven to be a safe therapeutic option in the treatment of tendon, muscle, bone, and cartilage injuries.
PURPOSE


To determine the effectiveness of PRP as compared with corticosteroid injections for chronic plantar fasciitis.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 1.
METHODS


Patients with chronic plantar fasciitis were allocated to have steroid injection or PRP. The primary outcome measure was the Foot Function Index (FFI) Pain score. Secondary outcome measures were function, as scored by the FFI Activity, FFI Disability, and American Orthopaedic Foot & Ankle Society, and quality of life, as scored with the short version of the World Health Organization Quality of Life (WHOQOL-BREF). All outcomes were measured at baseline and at 4, 12, and 26 weeks and 1 year after the procedure.
RESULTS


Of the 115 patients, 63 were allocated to the PRP group, of which 46 (73%) completed the study, and 52 were allocated to the control group (corticosteroid injection), of which 36 (69%) completed the study. In the control group, FFI Pain scores decreased quickly and then remained stable during follow-up. In the PRP group, FFI Pain reduction was more modest but reached a lower point after 12 months than the control group. After adjusting for baseline differences, the PRP group showed significantly lower pain scores at the 1-year follow-up than the control group (mean difference, 14.4; 95% CI, 3.2-25.6). The number of patients with at least 25% improvement (FFI Pain score) between baseline and 12-month follow-up differed significantly between the groups. Of the 46 patients in the PRP group, 39 (84.4%) improved at least 25%, while only 20 (55.6%) of the 36 in the control group showed such an improvement ( P  = .003). The PRP group showed significantly lower FFI Disability scores than the control group (mean difference, 12.0; 95% CI, 2.3-21.6).
CONCLUSION


Treatment of patients with chronic plantar fasciitis with PRP seems to reduce pain and increase function more as compared with the effect of corticosteroid injection.
REGISTRATION


NCT00758641 (ClinicalTrials.gov identifier).",2019,"In the PRP group, FFI Pain reduction was more modest but reached a lower point after 12 months than the control group.","['115 patients', 'patients with chronic plantar fasciitis', 'Patients with chronic plantar fasciitis', 'Plantar Fasciitis']","['Corticosteroid injection', 'Platelet-Rich Plasma', 'Platelet-rich plasma (PRP', 'steroid injection or PRP', 'PRP', 'corticosteroid injections', 'control group (corticosteroid injection']","['Pain score', 'pain scores', 'improvement (FFI Pain score', 'Foot Function Index (FFI', 'temporary pain reduction', 'FFI Pain reduction', 'FFI Disability scores', 'FFI Pain scores', 'function, as scored by the FFI Activity, FFI Disability, and American Orthopaedic Foot & Ankle Society, and quality of life, as scored with the short version of the World Health Organization Quality of Life (WHOQOL-BREF']","[{'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1136148', 'cui_str': 'Heel Spur Syndrome'}, {'cui': 'C0149756', 'cui_str': ""Policeman's Heel""}]","[{'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C4706287', 'cui_str': 'Foot Function Index (assessment scale)'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0034380'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}]",63.0,0.126549,"In the PRP group, FFI Pain reduction was more modest but reached a lower point after 12 months than the control group.","[{'ForeName': 'Joost C', 'Initials': 'JC', 'LastName': 'Peerbooms', 'Affiliation': 'Department of Orthopaedics, Albert Schweitzer Ziekenhuis, Dordrecht, the Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lodder', 'Affiliation': 'Department of Methodology and Statistics, Tilburg University, Tilburg, the Netherlands.'}, {'ForeName': 'Brenda L', 'Initials': 'BL', 'LastName': 'den Oudsten', 'Affiliation': 'Department of Medical and Clinical Psychology, Centre of Research on Psychological and Somatic Disorders, Tilburg University, Tilburg, the Netherlands.'}, {'ForeName': 'Kamiel', 'Initials': 'K', 'LastName': 'Doorgeest', 'Affiliation': 'Department of Orthopaedics, Ikazia Ziekenhuis, Rotterdam, the Netherlands.'}, {'ForeName': 'Hans M', 'Initials': 'HM', 'LastName': 'Schuller', 'Affiliation': 'Department of Orthopaedics, Diaconessenhuis Leiden, the Netherlands.'}, {'ForeName': 'Taco', 'Initials': 'T', 'LastName': 'Gosens', 'Affiliation': 'Department of Orthopaedics, Elisabeth Ziekenhuis Tilburg, the Netherlands.'}]",The American journal of sports medicine,['10.1177/0363546519877181']
383,32302717,Predictors of Change in Left-Ventricular Structure and Function in a Trial of Extended Hours Hemodialysis.,"BACKGROUND


Myocardial pathology is common in patients undergoing hemodialysis. To explore the effects of differing aspects of dialysis treatment on its evolution, we examined the impact of change in markers of volume status, hemodynamics and solute clearance on left ventricular (LV) parameters in a randomized trial of extended hours dialysis.
METHODS AND RESULTS


A Clinical Trial of IntensiVE (ACTIVE) Dialysis randomized 200 patients undergoing hemodialysis to extended dialysis hours (≥ 24 hours/week) or standard hours (12-18 hours/week) for 12 months. In a prespecified substudy, 95 participants underwent cardiac magnetic resonance imaging (CMR) at baseline and at the study's end. Generalized linear regression was used to model the relationship between changes in LV parameters and markers of volume status (normalized ultrafiltration rate and total weekly interdialytic weight gain), hemodynamic changes (systolic and diastolic blood pressure) and solute control (urea clearance, dialysis hours and phosphate). Randomization to extended hours dialysis was not associated with change in any CMR parameter. Reduction in ultrafiltration rate was associated with reduction in LV mass index (P = 0.049) and improved ejection fraction (P = 0.024); reduction in systolic blood pressure was also associated with improvement in ejection fraction (P = 0.045); reduction in interdialytic weight gain was associated with reduced stroke volume (P = 0.038). There were no associations between change in urea clearance, phosphate or total hours per week and CMR parameters.
CONCLUSIONS


Reduction in ultrafiltration rate and blood pressure are associated with improved myocardial parameters in hemodialysis recipients independently of solute clearance or dialysis time. These findings underscore the importance of fluid status and related parameters as potential treatment targets in this population.",2020,Reduction in UF rate was associated with reduction in LV mass index (LVMI) (P=0.049) and improved ejection fraction (EF) (P=0.024); reduction in systolic BP was also associated with improvement in EF (P=0.045); reduction in IDWG was associated with reduced stroke volume (SV) (P=0.038).,"['200 hemodialysis patients to extended dialysis hours (≥ 24 hours/week) or standard hours (12-18 hours/week) for 12 months', 'hemodialysis recipients', '95 participants underwent', 'hemodialysis patients']","['dialysis treatment', 'cardiac magnetic resonance imaging (CMR']","['ejection fraction (EF', 'myocardial parameters', 'Kt/V, phosphate or total hours per week, and CMR parameters', 'UF rate', 'systolic BP', 'volume status (normalized ultrafiltration [UF] rate and total weekly interdialytic weight gain [IDWG]), hemodynamic changes (systolic and diastolic blood pressure [BP]) and solute control (Kt/V, dialysis hours and phosphate', 'LV mass index (LVMI', 'ultrafiltration rate and blood pressure', 'EF', 'reduced stroke volume (SV']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0556976', 'cui_str': 'hours/week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0429662', 'cui_str': 'kt/V'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0556976', 'cui_str': 'hours/week'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0041612', 'cui_str': 'Ultrafiltration'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}]",200.0,0.0410275,Reduction in UF rate was associated with reduction in LV mass index (LVMI) (P=0.049) and improved ejection fraction (EF) (P=0.024); reduction in systolic BP was also associated with improvement in EF (P=0.045); reduction in IDWG was associated with reduced stroke volume (SV) (P=0.038).,"[{'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Smyth', 'Affiliation': 'The George Institute for Global Health and University of New South Wales, Sydney, Australia; Sydney School of Public Health, University of Sydney, Sydney, Australia; Department of Renal Medicine, St George Hospital, Sydney, Australia. Electronic address: bsmyth@georgeinstitute.org.au.'}, {'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Chan', 'Affiliation': 'University Health Network, Toronto, Canada.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Grieve', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, Australia; Sydney Translational Imaging Laboratory, Charles Perkins Centre, University of Sydney, Sydney, Australia; Department of Radiology, Royal Prince Alfred Hospital, Sydney, Australia.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Puranik', 'Affiliation': 'Specialist Magnetic Resonance Imaging, Newtown, Australia; Department of Cardiology, Royal Prince Alfred Hospital, Sydney, Australia.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zuo', 'Affiliation': ""Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Daqing', 'Initials': 'D', 'LastName': 'Hong', 'Affiliation': ""Renal Department, Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Gray', 'Affiliation': 'Sunshine Coast University Hospital, Birtinya, Australia; School of Health and Sport Sciences, University of the Sunshine Coast, Australia.'}, {'ForeName': 'Janak R', 'Initials': 'JR', 'LastName': 'De Zoysa', 'Affiliation': 'North Shore Hospital, Auckland, New Zealand; Department of Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Anish', 'Initials': 'A', 'LastName': 'Scaria', 'Affiliation': 'The George Institute for Global Health and University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gallagher', 'Affiliation': 'The George Institute for Global Health and University of New South Wales, Sydney, Australia; Renal Unit, Concord Repatriation General Hospital, Sydney, Australia.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'The George Institute for Global Health and University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Jardine', 'Affiliation': 'The George Institute for Global Health and University of New South Wales, Sydney, Australia; Renal Unit, Concord Repatriation General Hospital, Sydney, Australia.'}]",Journal of cardiac failure,['10.1016/j.cardfail.2020.03.010']
384,32229581,Antidopaminergic treatment is associated with reduced chorea and irritability but impaired cognition in Huntington's disease (Enroll-HD).,"OBJECTIVES


Alterations in dopamine neurotransmission underlie some of the clinical features of Huntington's disease (HD) and as such are a target for therapeutic intervention, especially for the treatment of chorea and some behavioural problems. However, justification for such an intervention is mainly based on case reports and small open label studies and the effects these drugs have on cognition in HD remain unclear.
METHODS


In this study, we used the Enroll-HD observational database to assess the effects of antidopaminergic medication on motor, psychiatric and cognitive decline, over a 3-year period. We first looked at the annual rate of decline of a group of HD patients taking antidopaminergic medication (n=466) compared with an untreated matched group (n=466). The groups were matched on specified clinical variables using propensity score matching. Next, we studied a separate group of HD patients who were prescribed such medications part way through the study (n=90) and compared their rate of change before and after the drugs were introduced and compared this to a matched control group.
RESULTS


We found that HD patients taking antidopaminergic medication had a slower progression in chorea and irritability compared with those not taking such medications. However, this same group of patients also displayed significantly greater rate of decline in a range of cognitive tasks.
CONCLUSION


In conclusion we found that antidopaminergic treatment is associated with improvements in the choreic movements and irritability of HD but worsens cognition. However, further research is required to prospectively investigate this and whether these are causally linked, ideally in a double-blind placebo-controlled trial.",2020,In conclusion we found that antidopaminergic treatment is associated with improvements in the choreic movements and irritability of HD but worsens cognition.,"['HD patients taking antidopaminergic medication (n=466) compared with an untreated matched group (n=466', 'HD patients who were prescribed such medications part way through the study (n=90']","['antidopaminergic medication', 'Antidopaminergic']","['chorea and irritability', 'choreic movements and irritability of HD but worsens cognition', 'motor, psychiatric and cognitive decline']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0024908', 'cui_str': 'Matched Groups'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0008489', 'cui_str': 'Choreatic Syndromes'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0234985', 'cui_str': 'Cognitive Decline'}]",,0.0291193,In conclusion we found that antidopaminergic treatment is associated with improvements in the choreic movements and irritability of HD but worsens cognition.,"[{'ForeName': 'Kate L', 'Initials': 'KL', 'LastName': 'Harris', 'Affiliation': 'Department of Clinical Neurosciences, The University of Cambridge, Cambridge, United Kingdom kh600@cam.ac.uk.'}, {'ForeName': 'Wei-Li', 'Initials': 'WL', 'LastName': 'Kuan', 'Affiliation': 'Department of Clinical Neurosciences, The University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Mason', 'Affiliation': 'Department of Clinical Neurosciences, Cambridge Centre for Brain Repair, Cambridge, Cambridgeshire, United Kingdom.'}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Barker', 'Affiliation': 'Department of Clinical Neurosciences, John van Geest Centre for Brain Repair, and MRC-WT Cambridge Stem Cell Institute, University of Cambridge, Cambridge, United Kingdom.'}]","Journal of neurology, neurosurgery, and psychiatry",['10.1136/jnnp-2019-322038']
385,32144936,Transvenous lead extraction: Efficacy and safety of the procedure in octogenarian patients.,"BACKGROUND


Managing elderly patients with infection or malfunction deriving from a cardiac implantable electronic device (CIED) may be challenging. The aim of this study was to evaluate safety and efficacy of mechanical transvenous lead extraction (TLE) in elderly patients.
METHODS


Patients who had undergone TLE in single tertiary referral center were divided in two groups (group 1: ≥ 80 years; group 2: < 80 years) and their acute and chronic outcomes were compared. All patients were treated with manual traction or mechanical dilatation.
RESULTS


Our analysis included 1316 patients (group 1: 202; group 2: 1114 patients), with a total of 2513 leads extracted. Group 1 presented more comorbidities, more pacemakers than implantable cardioverter-defibrillators, whereas the dwelling time of the oldest lead and the number of leads were similar, irrespective of patient's age. In group 1, the radiological success rate for lead was higher (99.0% vs 95.9%; P < .001) and the fluoroscopy time lower (13.0 vs 15.0 min; P = .04) than in group 2. Clinical success was reached in 1273 patients (96.7%), without significant differences between groups (group 1: 98.0% vs group 2: 96.4%; P = .36). Major complications occurred in 10 patients (0.7%) without significative differences between patients with more or less than 80 years (group 1: 1.5% vs group 2: 0.6%; P = .24) and with no procedure-related deaths in elderly group.
CONCLUSIONS


Mechanical TLE in elderly patients is a safe and effective procedure. In the over-80s, a comparable incidence of major complications with younger patients was observed, with at least a similar efficacy of the procedure.",2020,"Clinical success was reached in 1273 patients (96.7%), without significant differences between groups (group 1: 98.0% vs group 2: 96.4%; P = .36).","['1316 patients (group 1: 202; group 2: 1114 patients), with a total of 2513 leads extracted', 'Patients who had undergone TLE in single tertiary referral center', 'elderly patients', 'elderly patients with infection or malfunction deriving from a', 'octogenarian patients']","['implantable cardioverter-defibrillators', 'cardiac implantable electronic device (CIED', 'manual traction or mechanical dilatation', 'Mechanical TLE', 'mechanical transvenous lead extraction (TLE', 'Transvenous lead extraction']","['Major complications', 'safety and efficacy', 'Clinical success', 'fluoroscopy time lower', 'radiological success rate for lead']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0014556', 'cui_str': 'Temporal lobe epilepsy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0028829', 'cui_str': 'Octogenarians'}]","[{'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0010214', 'cui_str': 'Countercurrent electrophoresis measurement'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0040597', 'cui_str': 'Traction'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0014556', 'cui_str': 'Temporal lobe epilepsy'}, {'cui': 'C0522521', 'cui_str': 'Transvenous approach'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]",2513.0,0.0470997,"Clinical success was reached in 1273 patients (96.7%), without significant differences between groups (group 1: 98.0% vs group 2: 96.4%; P = .36).","[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Giannotti Santoro', 'Affiliation': 'Cardiology Department, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Segreti', 'Affiliation': 'Cardiology Department, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Zucchelli', 'Affiliation': 'Cardiology Department, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Barletta', 'Affiliation': 'Cardiology Department, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Fiorentini', 'Affiliation': 'Cardiology Department, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Di Cori', 'Affiliation': 'Cardiology Department, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'De Lucia', 'Affiliation': 'Cardiology Department, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Bongiorni', 'Affiliation': 'Cardiology Department, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.'}]",Pacing and clinical electrophysiology : PACE,['10.1111/pace.13896']
386,31654548,"Efficacy of fibrinogen concentrate in major abdominal surgery - A prospective, randomized, controlled study in cytoreductive surgery for pseudomyxoma peritonei.","BACKGROUND


Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy for pseudomyxoma peritonei (PMP) is associated with excessive bleeding and acquired fibrinogen deficiency. Maintaining plasma fibrinogen may support hemostasis.
OBJECTIVES


To compare hemostatic efficacy and safety of human fibrinogen concentrate (HFC) vs cryoprecipitate as fibrinogen sources for bleeding patients with acquired fibrinogen deficiency undergoing PMP CRS.
METHODS


FORMA-05 was an off-label single-center, prospective, randomized, controlled phase 2 study. Patients undergoing PMP surgery with predicted intraoperative blood loss ≥2 L received human fibrinogen concentrate (HFC; 4 g) or cryoprecipitate (two pools of 5 units, containing approximately 4.0-4.6 g fibrinogen), repeated as needed. The primary endpoint was a composite of intraoperative and postoperative efficacy, graded using objective 4-point scales and adjudicated by an independent committee.
RESULTS


One hundred percent of patients receiving HFC (95% confidence interval: 83.9-100.0, n = 21) or cryoprecipitate (84.6-100.0, n = 22) achieved hemostatic success. HFC demonstrated noninferior efficacy (P = .0095; post hoc) and arrived in the operating room 46 minutes faster. There were significantly greater mean increases with HFC vs cryoprecipitate in plasma fibrinogen (0.78 vs 0.35 g/L; P < .0001) and FIBTEM A20 (3.33 vs 0.93 mm; P = .003). Factor XIII, factor VIII, and von Willebrand factor activity were maintained throughout surgery. Only red blood cells were transfused intraoperatively (median units: HFC group, 1.0; cryoprecipitate group, 0.5). Thromboembolic events were detected with cryoprecipitate only. Safety was otherwise comparable between groups.
CONCLUSIONS


Human fibrinogen concentrate was hemostatically efficacious in patients undergoing major abdominal PMP surgery, with a favorable safety profile. These results are relevant to other surgical settings where bleeding and acquired fibrinogen deficiency occur.",2020,HFC demonstrated non-inferior efficacy (p=0.0095; post hoc) and arrived in the operating room 46 minutes faster.,"['bleeding patients with acquired fibrinogen deficiency undergoing PMP CRS', 'cytoreductive surgery for pseudomyxoma peritonei', 'major abdominal surgery ', 'patients undergoing major abdominal PMP surgery', 'Patients undergoing PMP surgery with predicted intraoperative blood loss ≥2 L received']","['fibrinogen concentrate', 'human fibrinogen concentrate (HFC', 'Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy', 'HFC']","['Factor XIII, factor VIII and von Willebrand factor activity', 'red blood cells', 'Safety', 'plasma fibrinogen', 'Thromboembolic events', 'HFC demonstrated non-inferior efficacy', 'hemostatic efficacy and safety', 'composite of intraoperative and postoperative efficacy, graded using objective 4-point scales and adjudicated by an independent committee', 'hemostatic success']","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439661', 'cui_str': 'Acquired (qualifier value)'}, {'cui': 'C4316812', 'cui_str': 'Fibrinogen Deficiency'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive Surgery'}, {'cui': 'C0033822', 'cui_str': 'Syndrome of Pseudomyxoma Peritonei'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}]","[{'cui': 'C2587184', 'cui_str': 'fibrinogen concentrate (human)'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive Surgery'}, {'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}]","[{'cui': 'C0015528', 'cui_str': 'coagulation factor XIII'}, {'cui': 'C0015506', 'cui_str': 'coagulation factor VIII'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0856510', 'cui_str': 'Plasma fibrinogen'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0019120', 'cui_str': 'Hemostatics'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0222045'}, {'cui': 'C1299583', 'cui_str': 'Independent'}]",,0.278666,HFC demonstrated non-inferior efficacy (p=0.0095; post hoc) and arrived in the operating room 46 minutes faster.,"[{'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': 'Basingstoke and North Hampshire Hospital, Basingstoke, UK.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Stanford', 'Affiliation': 'Basingstoke and North Hampshire Hospital, Basingstoke, UK.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Nunn', 'Affiliation': 'Basingstoke and North Hampshire Hospital, Basingstoke, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Alves', 'Affiliation': 'Basingstoke and North Hampshire Hospital, Basingstoke, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Sargant', 'Affiliation': 'Basingstoke and North Hampshire Hospital, Basingstoke, UK.'}, {'ForeName': 'Savita', 'Initials': 'S', 'LastName': 'Rangarajan', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, UK.'}, {'ForeName': 'Emily Arbuthnot', 'Initials': 'EA', 'LastName': 'Smith', 'Affiliation': 'Basingstoke and North Hampshire Hospital, Basingstoke, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bell', 'Affiliation': 'Basingstoke and North Hampshire Hospital, Basingstoke, UK.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Dayal', 'Affiliation': 'Basingstoke and North Hampshire Hospital, Basingstoke, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Cecil', 'Affiliation': 'Basingstoke and North Hampshire Hospital, Basingstoke, UK.'}, {'ForeName': 'Alexios', 'Initials': 'A', 'LastName': 'Tzivanakis', 'Affiliation': 'Basingstoke and North Hampshire Hospital, Basingstoke, UK.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Kruzhkova', 'Affiliation': 'Octapharma AG, Lachen, Switzerland.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Solomon', 'Affiliation': 'Octapharma AG, Lachen, Switzerland.'}, {'ForeName': 'Sigurd', 'Initials': 'S', 'LastName': 'Knaub', 'Affiliation': 'Octapharma AG, Lachen, Switzerland.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Moran', 'Affiliation': 'Basingstoke and North Hampshire Hospital, Basingstoke, UK.'}, {'ForeName': 'Faheez', 'Initials': 'F', 'LastName': 'Mohamed', 'Affiliation': 'Basingstoke and North Hampshire Hospital, Basingstoke, UK.'}]",Journal of thrombosis and haemostasis : JTH,['10.1111/jth.14665']
387,32198929,Noninvasive cardiac output measurement based optimization in nonresponders of cardiac resynchronization therapy.,"BACKGROUND


Cardiac resynchronization therapy (CRT) is an important and effective therapy for end-stage heart failure (HF). Nonresponse to CRT is one of the main obstacles to its application in clinical practice. Herein, we investigated the utilization of the optimization technique using noninvasive cardiac output measurement (NICOM) based Mobil-O-Graph device that measures several circulation parameters noninvasively.
METHODS


Seventy-five CRT nonresponder HF patients with an implanted CRT device were included. Patients were randomized equally to 3 groups: NICOM, echocardiographic, and empirical optimization groups. After 3 months of optimization, changes in six minutes walk test (6-MWT), cardiac output (CO), left ventricular ejection fraction (LVEF), and end-systolic volume (LVESV) were measured. New York Heart Association (NYHA) class and hospitalization for HF were also determined.
RESULTS


There were no statistically significant differences among the three groups in terms of demographics, baseline characteristics. In the NICOM group, the 6-MWT, LVEF, CO, and LVESV measurements showed significant improvements compared to baseline values (P < .05). There was no significant improvement in 6-MWT, LVEF, CO, NYHA class, and LVESV in Echo and Empirical groups after 3 months (P > .05). 6-MWT, CO, LVESV percentages, and hospitalization for HF were significantly different between the groups (P < .05). In post hoc analyzes, the percentages of the change in 6-MWT, CO, LVESV, and hospitalization for HF were significantly higher in the NICOM group (P < .017).
CONCLUSIONS


This study suggests that Mobil-O-Graph device optimization according to CO measures does appear to have potential hemodynamic and clinical benefits in nonresponder CRT patients. Use of Mobil-O-Graph device as an option for optimization of CRT devices can be an attractive method of improving CRT outcomes.",2020,"There was no significant improvement in 6-MWT, LVEF, CO, NYHA class and LVESV in Echo and Empirical groups after 3 months (p > 0.05).",['Seventy-five CRT non-responder heart failure patients with an implanted CRT device were included'],"['NICOM based Mobil-O-Graph device', 'Mobil-O-Graph device']","['6-MWT, CO, LVESV and hospitalization for HF', '6-minute walk test(6-MWT), cardiac output(CO), left ventricular ejection fraction(LVEF) and end-systolic volumes(LVESV', '6-MWT, LVEF, CO, NYHA class and LVESV', 'NYHA class and hospitalization for HF', '6-MWT, LVEF, CO and LVESV measurements', '6-MWT, CO, LVESV percentages and hospitalization for HF']","[{'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",75.0,0.0318589,"There was no significant improvement in 6-MWT, LVEF, CO, NYHA class and LVESV in Echo and Empirical groups after 3 months (p > 0.05).","[{'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Yenerçağ', 'Affiliation': 'Department of Cardiology, University of Health Sciences, Samsun Training and Research Hospital, Samsun, Turkey.'}, {'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Yüksel', 'Affiliation': 'Department of Cardiology, Ondokuz Mayıs University Hospital, Samsun, Turkey.'}, {'ForeName': 'Metin', 'Initials': 'M', 'LastName': 'Çoksevim', 'Affiliation': 'Department of Cardiology, Ondokuz Mayıs University Hospital, Samsun, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Akçay', 'Affiliation': 'Department of Cardiology, Ondokuz Mayıs University Hospital, Samsun, Turkey.'}, {'ForeName': 'Uğur', 'Initials': 'U', 'LastName': 'Arslan', 'Affiliation': 'Department of Cardiology, University of Health Sciences, Samsun Training and Research Hospital, Samsun, Turkey.'}]",Pacing and clinical electrophysiology : PACE,['10.1111/pace.13904']
388,31691462,Efficacy and safety of open-label caplacizumab in patients with exacerbations of acquired thrombotic thrombocytopenic purpura in the HERCULES study.,"BACKGROUND


Acquired thrombotic thrombocytopenic purpura (aTTP) is a rare, life-threatening autoimmune thrombotic microangiopathy. Caplacizumab, an anti-von Willebrand Factor Nanobody ®  , is effective for treating aTTP episodes and is well tolerated.
OBJECTIVES AND METHODS


In the phase 3 HERCULES trial (NCT02553317), patients with aTTP received double-blind caplacizumab or placebo during daily therapeutic plasma exchange (TPE) and for ≥30 days thereafter. Patients who experienced an exacerbation while on blinded study drug treatment switched to receive open-label caplacizumab plus re-initiation of daily TPE. Exacerbations were defined as recurrence of disease occurring within 30 days after cessation of daily TPE.
RESULTS


Thirty-one patients (placebo, n = 28; caplacizumab, n = 3) had an exacerbation during double-blind treatment. Twenty-eight patients switched to open-label caplacizumab (placebo, n = 26; caplacizumab, n = 2); the three others discontinued upon exacerbation. Median time to platelet count response (≥150 × 10 9  /L) was 3.49 days upon receiving caplacizumab. There were no deaths. During open-label treatment, further exacerbation or a major thromboembolic event (vena cava thrombosis) was experienced by one patient (3.6%) each. Consistent with the double-blind phase, the most frequent treatment-emergent adverse events were catheter site hemorrhage (28.6%), headache (21.4%), and epistaxis (17.9%).
CONCLUSIONS


These results suggest that caplacizumab was efficacious and well tolerated in patients with aTTP who experienced a disease exacerbation during double-blind treatment in HERCULES.",2020,Median time to platelet count response (≥150 x 10 9  /L) was 3.49 days upon receiving caplacizumab.,"['patients with exacerbations of acquired thrombotic thrombocytopenic purpura in the HERCULES study', 'Patients who experienced an exacerbation while on blinded study drug treatment switched to', 'patients with aTTP received']","['receive open-label caplacizumab plus re-initiation of daily TPE', 'Caplacizumab', 'open-label caplacizumab', 'caplacizumab', 'double-blind caplacizumab or placebo', 'open-label caplacizumab (placebo']","['efficacious and well tolerated', 'Median time to platelet count response', 'catheter site hemorrhage', 'headache', 'disease exacerbation', 'Efficacy and safety', 'exacerbation or a major thromboembolic event (vena cava thrombosis', 'epistaxis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2584778', 'cui_str': 'Moschowitz syndrome'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C3713057', 'cui_str': 'caplacizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0920166', 'cui_str': 'Catheter site haemorrhage'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0235874', 'cui_str': 'Disease Exacerbation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0265050', 'cui_str': 'Thrombosis of vena cava (disorder)'}, {'cui': 'C0014591', 'cui_str': 'Nosebleed'}]",31.0,0.471274,Median time to platelet count response (≥150 x 10 9  /L) was 3.49 days upon receiving caplacizumab.,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Knoebl', 'Affiliation': 'Division of Hematology and Hemostasis, Department of Medicine 1, Medical University of Vienna, Wien, Austria.'}, {'ForeName': 'Spero', 'Initials': 'S', 'LastName': 'Cataland', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Peyvandi', 'Affiliation': ""Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Coppo', 'Affiliation': 'Department of Hematology, Reference Center for Thrombotic Microangiopathies (CNR-MAT), Saint-Antoine University Hospital, AP-HP, Paris, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Scully', 'Affiliation': 'Cardiometabolic Programme-NIHR UCLH/UCL BRC, Department of Haematology, University College London Hospital, London, UK.'}, {'ForeName': 'Johanna A', 'Initials': 'JA', 'LastName': 'Kremer Hovinga', 'Affiliation': 'Department of Hematology and Central Hematology Laboratory, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Ara', 'Initials': 'A', 'LastName': 'Metjian', 'Affiliation': 'Department of Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'de la Rubia', 'Affiliation': 'Hematology Department, Internal Medicine, School of Medicine and Dentistry, Catholic University of Valencia, Valencia, Spain.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Pavenski', 'Affiliation': ""Departments of Medicine and Laboratory Medicine, St. Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Minkue Mi Edou', 'Affiliation': 'Clinical Development, Ablynx, a Sanofi Company, Ghent, Belgium.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'De Winter', 'Affiliation': 'Formerly Clinical Development, Ablynx, a Sanofi Company, Ghent, Belgium.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Callewaert', 'Affiliation': 'Medical Affairs, Sanofi, Diegem, Belgium.'}]",Journal of thrombosis and haemostasis : JTH,['10.1111/jth.14679']
389,32297837,Reducing Cardiovascular Disease Risk in Women Beyond Statin Therapy: New Insights 2020.,"Management of residual and persistent cardiovascular disease (CVD) risk among statin-treated individuals has emerged as an important preventive strategy. The purpose of this article is to review the unique landscape of CVD in women and relevant prior prevention trials, and to discuss how the recent results of the Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial (REDUCE-IT) might apply to the contemporary management of CVD risk among statin-treated women. Women have unique risk factors that may impact CVD and its prevention. Historically, women have been underrepresented in CVD trials, posing a challenge to development of clinical recommendations for women. Low-density lipoprotein cholesterol-targeting treatments have demonstrated CVD risk reduction, with comparable effects in both sexes. In contrast, triglyceride-lowering treatments (niacin, fenofibrate, and omega-3 fatty acids) have reported mixed findings for CVD risk reduction. Recent clinical trials of combination omega-3 fatty acids (docosahexaenoic acid/eicosapentaenoic acid [EPA]) have not found significant CVD risk reduction. The recently published REDUCE-IT study found that icosapent ethyl, an EPA-only omega-3 fatty acid, in combination with statins, significantly reduced CVD events in high-risk patients. The icosapent ethyl group had a significantly lower occurrence of the primary composite CVD endpoint (17.2%) than the placebo group (22.0%; hazard ratio 0.75; 95% confidence interval 0.68-0.83;  p  < 0.001). CVD risk reduction with icosapent ethyl treatment was comparable between women and men ( p  for interaction, 0.33). Data from REDUCE-IT suggest women benefit similarly to men with respect to icosapent ethyl, a novel therapy for prevention of CVD.",2020,"CVD risk reduction with icosapent ethyl treatment was comparable between women and men ( p  for interaction, 0.33).",['high-risk patients'],"['triglyceride-lowering treatments (niacin, fenofibrate, and omega-3 fatty acids', 'placebo', 'combination omega-3 fatty acids (docosahexaenoic acid/eicosapentaenoic acid [EPA']","['CVD risk reduction', 'CVD events', 'primary composite CVD endpoint']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027996', 'cui_str': 'Niacin'}, {'cui': 'C0033228', 'cui_str': 'Fenofibrate'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}]","[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",,0.0558982,"CVD risk reduction with icosapent ethyl treatment was comparable between women and men ( p  for interaction, 0.33).","[{'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Mosca', 'Affiliation': 'Division of Cardiology, Department of Medicine, Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Ann Marie', 'Initials': 'AM', 'LastName': 'Navar', 'Affiliation': 'Department of Medicine, Division of Cardiology, Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Nanette', 'Initials': 'N', 'LastName': 'Kass Wenger', 'Affiliation': ""Department of Cardiology, Emory University School of Medicine; Emory Heart and Vascular Center; Emory Women's Heart Center, Atlanta, Georgia.""}]",Journal of women's health (2002),['10.1089/jwh.2019.8189']
390,31852424,Myocardial Effects of Aldosterone Antagonism in Heart Failure With Preserved Ejection Fraction.,"Background Spironolactone may have prognostic benefit in selected patients with heart failure with preserved ejection fraction. This study assessed the myocardial tissue effects of spironolactone in heart failure with preserved ejection fraction. Methods and Results A 1:1 randomized controlled study of 6 months of spironolactone versus control in heart failure with preserved ejection fraction. The primary outcome was change in myocardial extracellular volume fraction by cardiovascular magnetic resonance as a surrogate of diffuse fibrosis. Of 55 randomized patients, 40 (20 women; age, 75.2±5.9 years) completed follow-up (19 treatment, 21 control). A significant change in extracellular volume over the study period was not seen (treatment, 28.7±3.7% versus 27.7±3.4% [ P =0.14]; controls, 27.6±3.4% versus 28.3±4.4% [ P =0.14]); however, the rate of extracellular volume expansion was decreased by spironolactone (-1.0±2.4% versus 0.8±2.2%). Indexed left ventricular mass decreased with treatment (104.4±26.6 versus 94.0±20.6 g/m 2 ;  P =0.001) but not in controls (101.4±29.4 versus 104.0±32.8 g/m 2 ;  P =0.111). Extracellular mass decreased by 13.8% (15.1±4.8 versus 13.0±3.4 g/m 2 ;  P =0.003), and cellular mass decreased by 8.3% (37.6±10.0 versus 34.3±7.9 g/m 2 ;  P =0.001) with spironolactone, but was static in controls. Conclusions Spironolactone did not lead to significant change in extracellular volume. However, spironolactone did decrease rate of extracellular expansion, with a decrease in the mass of both cellular and extracellular myocardial compartments. These data point to the mechanism of action of spironolactone in heart failure with preserved ejection fraction, including a direct tissue effect with a reduction in rate of myocardial fibrosis.",2020,Indexed left ventricular mass decreased with treatment (104.4±26.6 versus 94.0±20.6 g/m 2 ;  P =0.001) but not in controls (101.4±29.4 versus 104.0±32.8 g/m 2 ;  P =0.111).,"['Heart Failure', 'selected patients with heart failure with preserved ejection fraction', 'heart failure with preserved ejection fraction', '55 randomized patients, 40 (20 women; age, 75.2±5.9\xa0years) completed follow-up (19 treatment, 21 control']","['spironolactone', 'Aldosterone Antagonism', 'Spironolactone', ' Spironolactone']","['rate of myocardial fibrosis', 'myocardial extracellular volume fraction by cardiovascular magnetic resonance as a surrogate of diffuse fibrosis', 'rate of extracellular volume expansion', 'Indexed left ventricular mass', 'extracellular volume', 'rate of extracellular expansion', 'cellular mass', 'Extracellular mass', 'mass of both cellular and extracellular myocardial compartments']","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0373535', 'cui_str': 'Aldosterone measurement (procedure)'}]","[{'cui': 'C0151654', 'cui_str': 'Myocardial fibrosis'}, {'cui': 'C0521119', 'cui_str': 'Extracellular (qualifier value)'}, {'cui': 'C0560268', 'cui_str': 'Volume fraction'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C1265984', 'cui_str': 'Diffuse fibrosis'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass (finding)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",55.0,0.0497496,Indexed left ventricular mass decreased with treatment (104.4±26.6 versus 94.0±20.6 g/m 2 ;  P =0.001) but not in controls (101.4±29.4 versus 104.0±32.8 g/m 2 ;  P =0.111).,"[{'ForeName': 'Adam K', 'Initials': 'AK', 'LastName': 'McDiarmid', 'Affiliation': 'Multidisciplinary Cardiovascular Research Centre and Leeds Institute of Cardiovascular and Metabolic Medicine University of Leeds United Kingdom.'}, {'ForeName': 'Peter P', 'Initials': 'PP', 'LastName': 'Swoboda', 'Affiliation': 'Multidisciplinary Cardiovascular Research Centre and Leeds Institute of Cardiovascular and Metabolic Medicine University of Leeds United Kingdom.'}, {'ForeName': 'Bara', 'Initials': 'B', 'LastName': 'Erhayiem', 'Affiliation': 'Multidisciplinary Cardiovascular Research Centre and Leeds Institute of Cardiovascular and Metabolic Medicine University of Leeds United Kingdom.'}, {'ForeName': 'Katrina A', 'Initials': 'KA', 'LastName': 'Bounford', 'Affiliation': 'Leeds Teaching Hospitals NHS Trust Leeds United Kingdom.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Bijsterveld', 'Affiliation': 'Multidisciplinary Cardiovascular Research Centre and Leeds Institute of Cardiovascular and Metabolic Medicine University of Leeds United Kingdom.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Tyndall', 'Affiliation': 'Leeds Teaching Hospitals NHS Trust Leeds United Kingdom.'}, {'ForeName': 'Graham J', 'Initials': 'GJ', 'LastName': 'Fent', 'Affiliation': 'Multidisciplinary Cardiovascular Research Centre and Leeds Institute of Cardiovascular and Metabolic Medicine University of Leeds United Kingdom.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Garg', 'Affiliation': 'Multidisciplinary Cardiovascular Research Centre and Leeds Institute of Cardiovascular and Metabolic Medicine University of Leeds United Kingdom.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Dobson', 'Affiliation': 'Multidisciplinary Cardiovascular Research Centre and Leeds Institute of Cardiovascular and Metabolic Medicine University of Leeds United Kingdom.'}, {'ForeName': 'Tarique A', 'Initials': 'TA', 'LastName': 'Musa', 'Affiliation': 'Multidisciplinary Cardiovascular Research Centre and Leeds Institute of Cardiovascular and Metabolic Medicine University of Leeds United Kingdom.'}, {'ForeName': 'James R J', 'Initials': 'JRJ', 'LastName': 'Foley', 'Affiliation': 'Multidisciplinary Cardiovascular Research Centre and Leeds Institute of Cardiovascular and Metabolic Medicine University of Leeds United Kingdom.'}, {'ForeName': 'Klaus K', 'Initials': 'KK', 'LastName': 'Witte', 'Affiliation': 'Multidisciplinary Cardiovascular Research Centre and Leeds Institute of Cardiovascular and Metabolic Medicine University of Leeds United Kingdom.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Kearney', 'Affiliation': 'Multidisciplinary Cardiovascular Research Centre and Leeds Institute of Cardiovascular and Metabolic Medicine University of Leeds United Kingdom.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Greenwood', 'Affiliation': 'Multidisciplinary Cardiovascular Research Centre and Leeds Institute of Cardiovascular and Metabolic Medicine University of Leeds United Kingdom.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Plein', 'Affiliation': 'Multidisciplinary Cardiovascular Research Centre and Leeds Institute of Cardiovascular and Metabolic Medicine University of Leeds United Kingdom.'}]",Journal of the American Heart Association,['10.1161/JAHA.118.011521']
391,31846014,Effect of Rocuronium vs Succinylcholine on Endotracheal Intubation Success Rate Among Patients Undergoing Out-of-Hospital Rapid Sequence Intubation: A Randomized Clinical Trial.,"Importance


Rocuronium and succinylcholine are often used for rapid sequence intubation, although the comparative efficacy of these paralytic agents for achieving successful intubation in an emergency setting has not been evaluated in clinical trials. Succinylcholine use has been associated with several adverse events not reported with rocuronium.
Objective


To assess the noninferiority of rocuronium vs succinylcholine for tracheal intubation in out-of-hospital emergency situations.
Design, Setting and Participants


Multicenter, single-blind, noninferiority randomized clinical trial comparing rocuronium (1.2 mg/kg) with succinylcholine (1 mg/kg) for rapid sequence intubation in 1248 adult patients needing out-of-hospital tracheal intubation. Enrollment occurred from January 2014 to August 2016 in 17 French out-of-hospital emergency medical units. The date of final follow-up was August 31, 2016.
Interventions


Patients were randomly assigned to undergo tracheal intubation facilitated by rocuronium (n = 624) or succinylcholine (n = 624).
Main Outcomes and Measures


The primary outcome was the intubation success rate on first attempt. A noninferiority margin of 7% was chosen. A per-protocol analysis was prespecified as the primary analysis.
Results


Among 1248 patients who were randomized (mean age, 56 years; 501 [40.1%] women), 1230 (98.6%) completed the trial and 1226 (98.2%) were included in the per-protocol analysis. The number of patients with successful first-attempt intubation was 455 of 610 (74.6%) in the rocuronium group vs 489 of 616 (79.4%) in the succinylcholine group, with a between-group difference of -4.8% (1-sided 97.5% CI, -9% to ∞), which did not meet criteria for noninferiority. The most common intubation-related adverse events were hypoxemia (55 of 610 patients [9.0%]) and hypotension (39 of 610 patients [6.4%]) in the rocuronium group and hypoxemia (61 of 616 [9.9%]) and hypotension (62 of 616 patients [10.1%]) in the succinylcholine group.
Conclusions and Relevance


Among patients undergoing endotracheal intubation in an out-of-hospital emergency setting, rocuronium, compared with succinylcholine, failed to demonstrate noninferiority with regard to first-attempt intubation success rate.
Trial Registration


ClinicalTrials.gov Identifier: NCT02000674.",2019,"The most common intubation-related adverse events were hypoxemia (55 of 610 patients [9.0%]) and hypotension (39 of 610 patients [6.4%]) in the rocuronium group and hypoxemia (61 of 616 [9.9%]) and hypotension (62 of 616 patients [10.1%]) in the succinylcholine group.
","['1248 adult patients needing out-of-hospital tracheal intubation', '1248 patients who were randomized (mean age, 56 years; 501 [40.1%] women), 1230 (98.6%) completed the trial and 1226 (98.2%) were included in the per-protocol analysis', 'Patients Undergoing Out-of-Hospital Rapid Sequence Intubation', 'Enrollment occurred from January 2014 to August 2016 in 17 French out-of-hospital emergency medical units', 'tracheal intubation in out-of-hospital emergency situations', 'patients undergoing endotracheal intubation in an out-of-hospital emergency setting']","['rocuronium vs succinylcholine', 'tracheal intubation facilitated by rocuronium', 'succinylcholine', 'Rocuronium and succinylcholine', 'Succinylcholine', 'Rocuronium vs Succinylcholine', 'rocuronium']","['number of patients with successful first-attempt intubation', 'intubation success rate', 'hypotension', 'hypoxemia', 'Endotracheal Intubation Success Rate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0038627', 'cui_str': 'suxamethonium'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}]",1248.0,0.684436,"The most common intubation-related adverse events were hypoxemia (55 of 610 patients [9.0%]) and hypotension (39 of 610 patients [6.4%]) in the rocuronium group and hypoxemia (61 of 616 [9.9%]) and hypotension (62 of 616 patients [10.1%]) in the succinylcholine group.
","[{'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Guihard', 'Affiliation': 'Department of Emergency, CHU de la Réunion, Allée des Topazes, Saint Denis, Réunion, France.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Chollet-Xémard', 'Affiliation': 'Groupe Hospitalo-Universitaire Henri Mondor, SAMU 94, Assistance Publique-Hôpitaux de Paris, Créteil, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Lakhnati', 'Affiliation': 'SMUR 95, Centre Hospitalier de Gonesse, Gonesse, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Vivien', 'Affiliation': 'Department of Anesthesia & Critical Care - SAMU, Assistance Publique - Hôpitaux de Paris, Hôpital Necker-Enfants Malades, Université Paris Descartes, Paris, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Broche', 'Affiliation': ""Département d'Anesthésie-Réanimation-SMUR, Hôpital Universitaire Lariboisière, AP-HP, Paris, France.""}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Savary', 'Affiliation': 'Emergency Department, General Hospital of Annecy, Annecy, France.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Ricard-Hibon', 'Affiliation': ""SMUR de l'hôpital Beaujon, Clichy, France.""}, {'ForeName': 'Pierre-Jean', 'Initials': 'PJ', 'LastName': 'Marianne Dit Cassou', 'Affiliation': 'Department of Emergency, CHU de la Réunion, Réunion, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Adnet', 'Affiliation': 'AP-HP, Urgences-SAMU 93, Unité Recherche-Enseignement-Qualité, Hôpital Avicenne, Bobigny, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Wiel', 'Affiliation': 'Univ Lille, EA 2694 - Santé Publique: Epidémiologie et Qualité des Soins, Lille, France.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Deutsch', 'Affiliation': 'Department of Emergency Medicine, Groupe Hospitalier Broca Cochin Hôtel-Dieu, Paris, France.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Tissier', 'Affiliation': 'Department of Emergency Medicine, University Hospital Dijon, Dijon, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Loeb', 'Affiliation': 'Raymond Poincaré Hospital (APHP), SAMU 92, Paris, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Bounes', 'Affiliation': ""Pôle Médecine d'Urgence, Hôpital Universitaire de Purpan, Toulouse, France.""}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Rousseau', 'Affiliation': ""Services de Médecine d'Urgence et de Réanimation, Pôle Urgence Réanimation, SAMU 77, Melun, France.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Jabre', 'Affiliation': ""AP-HP, Service d'Aide Médicale d'Urgence (SAMU) de Paris and Paris Sudden Death Expertise Center, Université Paris Descartes, Paris, France.""}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Huiart', 'Affiliation': 'INSERM CIC 1410 Clinical and Epidemiology/ CHU Réunion/Université de la Réunion, Saint-Pierre, Reunion, France.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Ferdynus', 'Affiliation': ""Departement d'Informatique Clinique, Centre Hospitalier Universitaire de La Réunion Site Félix Guyon, Saint-Denis, France.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Combes', 'Affiliation': 'Department of Emergency, CHU de la Réunion, Université de la Réunion, Réunion, France.'}]",JAMA,['10.1001/jama.2019.18254']
392,31847572,The new TV dinner: effects of television programming content on eating and attitudes towards exercise.,"Evidence exists for a negative influence of exercise/weight-loss television on explicit attitudes towards exercise. However, it is unclear if this is specific to viewing intense exercise or the overweight/obese status of the viewed exercisers. Additionally, exposure to exercise cues can induce people to eat more, reflecting compensatory eating in response to exercise cues rather than actual exercise. In this study, we examined the relative influence of viewing overweight/obese versus normal weight exercisers on eating (calories consumed) and attitudes towards exercise. 102 college students were randomized to view: 1) overweight/obese individuals engaging in vigorous exercise; 2) normal weight individuals engaging in vigorous exercise; or 3) no-exercise video with participants of various weight statuses (control condition). Participants subsequently completed a taste test assessing calories consumed; a computerized, implicit attitudes-towards-exercise task; and an explicit attitudes-towards-exercise questionnaire. Participants with higher BMIs and those viewing normal weight exercisers (vs. overweight/obese exercisers) ate significantly more. No significant effects were found for the interaction between BMI and video or for explicit or implicit attitudes towards exercise. This study extends findings of the impact of viewing vigorous exercise to eating behaviors. If replicated under naturalistic conditions, findings have implications for health promotion initiatives and television programming impacting overeating.",2020,No significant effects were found for the interaction between BMI and video or for explicit or implicit attitudes towards exercise.,"['102 college students', 'Participants with higher BMIs and those viewing normal weight exercisers (vs. overweight/obese exercisers']","['television programming content', 'viewing overweight/obese versus normal weight exercisers on eating (calories consumed) and attitudes towards exercise', 'taste test assessing calories consumed; a computerized, implicit attitudes-towards-exercise task; and an explicit attitudes-towards-exercise questionnaire', 'viewing vigorous exercise', 'view: 1) overweight/obese individuals engaging in vigorous exercise; 2) normal weight individuals engaging in vigorous exercise; or 3) no-exercise video with participants of various weight statuses (control condition']","['eating and attitudes towards exercise', 'interaction between BMI and video or for explicit or implicit attitudes towards exercise']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0180776', 'cui_str': 'Exerciser'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0039461', 'cui_str': 'Television'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0180776', 'cui_str': 'Exerciser'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C3875042', 'cui_str': 'Attitude towards exercise (observable entity)'}, {'cui': 'C0039336', 'cui_str': 'Gustation'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C3875042', 'cui_str': 'Attitude towards exercise (observable entity)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}]",,0.0260631,No significant effects were found for the interaction between BMI and video or for explicit or implicit attitudes towards exercise.,"[{'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Szuhany', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, MA, USA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Otto', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, MA, USA.'}]","Psychology, health & medicine",['10.1080/13548506.2019.1705990']
393,31756291,Phenotype is sustained during hospital readmissions following treatment for complicated severe malnutrition among Kenyan children: A retrospective cohort study.,"Hospital readmission is common among children with complicated severe acute malnutrition (cSAM) but not well-characterised. Two distinct cSAM phenotypes, marasmus and kwashiorkor, exist, but their pathophysiology and whether the same phenotype persists at relapse are unclear. We aimed to test the association between cSAM phenotype at index admission and readmission following recovery. We performed secondary data analysis from a multicentre randomised trial in Kenya with 1-year active follow-up. The main outcome was cSAM phenotype upon hospital readmission. Among 1,704 HIV-negative children with cSAM discharged in the trial, 177 children contributed a total of 246 readmissions with cSAM. cSAM readmission was associated with age<12 months (p = .005), but not site, sex, season, nor cSAM phenotype. Of these, 42 children contributed 44 readmissions with cSAM that occurred after a monthly visit when SAM was confirmed absent (cSAM relapse). cSAM phenotype was sustained during cSAM relapse. The adjusted odds ratio for presenting with kwashiorkor during readmission after kwashiorkor at index admission was 39.3 [95% confidence interval (95% CI) [2.69, 1,326]; p = .01); and for presenting with marasmus during readmission after kwashiorkor at index admission was 0.02 (95% CI [0.001, 0.037]; p = .01). To validate this finding, we examined readmissions to Kilifi County Hospital, Kenya occurring at least 2 months after an admission with cSAM. Among 2,412 children with cSAM discharged alive, there were 206 readmissions with cSAM. Their phenotype at readmission was significantly influenced by their phenotype at index admission (p < .001). This is the first report describing the phenotype and rate of cSAM recurrence.",2020,"cSAM readmission was associated with age<12 months (p = .005), but not site, sex, season, nor cSAM phenotype.","['Kenyan children', '2,412 children with cSAM discharged alive, there were 206 readmissions with cSAM', '1,704 HIV-negative children with cSAM discharged in the trial, 177 children contributed a total of 246 readmissions with cSAM', 'children with complicated severe acute malnutrition (cSAM', 'Kenya with 1-year active follow-up', 'Kilifi County Hospital, Kenya occurring at least 2 months after an admission with cSAM']",[],"['cSAM phenotype upon hospital readmission', 'cSAM readmission', '44 readmissions with cSAM', 'Hospital readmission']","[{'cui': 'C0337839', 'cui_str': 'Kenyans (ethnic group)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C2933140', 'cui_str': 'AM206 cpd'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0020005', 'cui_str': 'Hospitals, County'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",[],"[{'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}]",2412.0,0.11712,"cSAM readmission was associated with age<12 months (p = .005), but not site, sex, season, nor cSAM phenotype.","[{'ForeName': 'Gerard Bryan', 'Initials': 'GB', 'LastName': 'Gonzales', 'Affiliation': 'Laboratory of Gastroenterology, Department of Internal Medicine and Paediatrics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Moses M', 'Initials': 'MM', 'LastName': 'Ngari', 'Affiliation': 'The Childhood Acute Illness & Nutrition (CHAIN) Network, Nairobi, Kenya.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Njunge', 'Affiliation': 'The Childhood Acute Illness & Nutrition (CHAIN) Network, Nairobi, Kenya.'}, {'ForeName': 'Johnstone', 'Initials': 'J', 'LastName': 'Thitiri', 'Affiliation': 'The Childhood Acute Illness & Nutrition (CHAIN) Network, Nairobi, Kenya.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mwalekwa', 'Affiliation': 'KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya.'}, {'ForeName': 'Neema', 'Initials': 'N', 'LastName': 'Mturi', 'Affiliation': 'KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya.'}, {'ForeName': 'Martha K', 'Initials': 'MK', 'LastName': 'Mwangome', 'Affiliation': 'The Childhood Acute Illness & Nutrition (CHAIN) Network, Nairobi, Kenya.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Ogwang', 'Affiliation': 'The Childhood Acute Illness & Nutrition (CHAIN) Network, Nairobi, Kenya.'}, {'ForeName': 'Amek', 'Initials': 'A', 'LastName': 'Nyaguara', 'Affiliation': 'The Childhood Acute Illness & Nutrition (CHAIN) Network, Nairobi, Kenya.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Berkley', 'Affiliation': 'The Childhood Acute Illness & Nutrition (CHAIN) Network, Nairobi, Kenya.'}]",Maternal & child nutrition,['10.1111/mcn.12913']
394,31774980,Evaluation of student perceptions with 2 interprofessional assessment tools-the Collaborative Healthcare Interdisciplinary Relationship Planning instrument and the Interprofessional Attitudes Scale-following didactic and clinical learning experiences in the United States.,"PURPOSE


This study investigated changes in students' attitudes using 2 validated interprofessional survey instruments-the Collaborative Healthcare Interdisciplinary Relationship Planning (CHIRP) instrument and the Interprofessional Attitudes Scale (IPAS)-before and after didactic and clinical cohorts.
METHODS


Students from 7 colleges/schools participated in didactic and clinical cohorts during the 2017-2018 year. Didactic cohorts experienced 2 interactive sessions 6 months apart, while clinical cohorts experienced 4 outpatient clinical sessions once monthly. For the baseline and post-cohort assessments, 865 students were randomly assigned to complete either the 14-item CHIRP or the 27-item IPAS. The Pittman test using permutations of linear ranks was used to determine differences in the score distribution between the baseline and post-cohort assessments. Pooled results were compared for the CHIRP total score and the IPAS total and subdomain scores. For each score, 3 comparisons were made simultaneously: overall baseline versus post-didactic cohort, overall baseline versus post-clinical cohort, and post-didactic cohort versus post-clinical cohort. Alpha was adjusted to 0.0167 to account for simultaneous comparisons.
RESULTS


The baseline and post-cohort survey response rates were 62.4% and 65.9% for CHIRP and 58.7% and 58.1% for IPAS, respectively. The post-clinical cohort scores for the IPAS subdomain of teamwork, roles, and responsibilities were significantly higher than the baseline and post-didactic cohort scores. No differences were seen for the remaining IPAS subdomain scores or the CHIRP instrument total score.
CONCLUSION


The IPAS instrument may discern changes in student attitudes in the subdomain of teamwork, roles, and responsibilities following short-term clinical experiences involving diverse interprofessional team members.",2019,"This study investigated changes in students' attitudes using 2 validated interprofessional survey instruments-the Collaborative Healthcare Interdisciplinary Relationship Planning (CHIRP) instrument and the Interprofessional Attitudes Scale (IPAS)-before and after didactic and clinical cohorts.
","['Students from 7 colleges/schools participated in didactic and clinical cohorts during the 2017-2018 year', '865 students', ""students' attitudes using 2 validated interprofessional survey instruments-the""]",['Collaborative Healthcare Interdisciplinary Relationship Planning (CHIRP) instrument and the Interprofessional Attitudes Scale (IPAS)-before and after didactic and clinical cohorts'],"['CHIRP total score and the IPAS total and subdomain scores', 'remaining IPAS subdomain scores or the CHIRP instrument total score']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C4551823', 'cui_str': 'instruments'}]","[{'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0222045'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0614109', 'cui_str': 'I(S)pA(S)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}]",,0.0516536,"This study investigated changes in students' attitudes using 2 validated interprofessional survey instruments-the Collaborative Healthcare Interdisciplinary Relationship Planning (CHIRP) instrument and the Interprofessional Attitudes Scale (IPAS)-before and after didactic and clinical cohorts.
","[{'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Dennis', 'Affiliation': 'Department of Pharmacy, Clinical and Administrative Sciences, College of Pharmacy, University of Oklahoma, Oklahoma City, OK, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Craft', 'Affiliation': 'Fran and Earl Ziegler College of Nursing, University of Oklahoma, Oklahoma City, OK, USA.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Bratzler', 'Affiliation': 'Department of Health Administration and Policy, College of Public Health, University of Oklahoma, Oklahoma City, OK, USA.'}, {'ForeName': 'Melody', 'Initials': 'M', 'LastName': 'Yozzo', 'Affiliation': 'Department of Family and Preventive Medicine, College of Medicine, University of Oklahoma, Oklahoma City, OK, USA.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Bender', 'Affiliation': 'Department of Rehabilitative Sciences, College of Allied Health, University of Oklahoma, Oklahoma City, OK, USA.'}, {'ForeName': 'Christi', 'Initials': 'C', 'LastName': 'Barbee', 'Affiliation': 'Department of Communication Sciences and Disorders, College of Allied Health, University of Oklahoma, Oklahoma City, OK, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Neely', 'Affiliation': 'Office of Instruction, Assessment, & Faculty Development, College of Pharmacy, University of Oklahoma, Oklahoma City, OK, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Robinson', 'Affiliation': 'Office of the Vice Provost for Academic Affairs & Faculty Development, University of Oklahoma, Oklahoma City, OK, USA.'}]",Journal of educational evaluation for health professions,['10.3352/jeehp.2019.16.35']
395,32240909,Compliance and tolerability of short-course radiotherapy followed by preoperative chemotherapy and surgery for high-risk rectal cancer - Results of the international randomized RAPIDO-trial.,"BACKGROUND


Preoperative chemoradiotherapy (CRT) followed by total mesorectal excision is widely accepted as the standard of care for high-risk rectal cancer. Adjuvant chemotherapy is advised in several international guidelines, although the survival benefit remains unclear and compliance is poor. The current multidisciplinary approach has led to major improvements in local control, yet the occurrence of distant metastases has not decreased accordingly. The combination of short-course radiotherapy (SCRT) and chemotherapy in the waiting period before surgery might have several benefits, including higher compliance, downstaging and better effect of systemic therapy.
METHODS


This is an investigator-initiated, international multicentre randomized phase III trial. High-risk rectal cancer patients were randomized to SCRT followed by chemotherapy (6 cycles CAPOX or alternatively 9 cycles FOLFOX4) and subsequent surgery, or long-course radiotherapy (25-28 × 2-1.8 Gy) with concomitant capecitabine followed by surgery and optional postoperative chemotherapy (8 cycles CAPOX or 12 cycles FOLFOX4) according to local institutions' policy. The primary endpoint is time to disease-related treatment failure. Here, we report the compliance, toxicity and postoperative complications in both study groups.
FINDINGS


Between June 2011 and June 2016, 920 patients were enrolled. Of these, 901 were evaluable (460 in the experimental arm and 441 in the standard arm). All patients in the experimental arm received 5 × 5 Gy radiotherapy, and 84% of all patients received at least 75% of the prescribed chemotherapy. In the standard arm, the compliance for CRT was 94% and 57% for postoperative chemotherapy. Toxicity ≥grade 3 occurred in 48% of patients in the experimental arm, compared to 25% of patients in the standard arm during preoperative treatment and 35% of patients during postoperative chemotherapy. No statistically significant differences in surgical procedures or postoperative complications were observed.
INTERPRETATION


High compliance (84%) of preoperative systemic treatment could be achieved with the experimental approach. Although considerable toxicity was observed during preoperative therapy, this did not lead to differences in surgical procedures or postoperative complications. Longer follow-up time is needed to assess the primary endpoint and related outcomes.",2020,"Toxicity ≥grade 3 occurred in 48% of patients in the experimental arm, compared to 25% of patients in the standard arm during preoperative treatment and 35% of patients during postoperative chemotherapy.","['High-risk rectal cancer patients', 'high-risk rectal cancer ', 'Between June 2011 and June 2016, 920 patients were enrolled', '901 were evaluable (460 in the experimental arm and 441 in the standard arm']","['short-course radiotherapy', '5\xa0×\xa05 Gy radiotherapy', 'preoperative chemotherapy and surgery', 'short-course radiotherapy (SCRT) and chemotherapy', 'Adjuvant chemotherapy', 'Preoperative chemoradiotherapy (CRT', 'SCRT followed by chemotherapy (6 cycles CAPOX or alternatively 9 cycles FOLFOX4) and subsequent surgery, or long-course radiotherapy', 'concomitant capecitabine followed by surgery and optional postoperative chemotherapy']","['Toxicity ≥grade 3', 'time to disease-related treatment failure', 'Compliance and tolerability', 'compliance, toxicity and postoperative complications', 'toxicity', 'surgical procedures or postoperative complications']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C1273551', 'cui_str': 'Postoperative chemotherapy'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]",920.0,0.114836,"Toxicity ≥grade 3 occurred in 48% of patients in the experimental arm, compared to 25% of patients in the standard arm during preoperative treatment and 35% of patients during postoperative chemotherapy.","[{'ForeName': 'Maxime J M', 'Initials': 'MJM', 'LastName': 'van der Valk', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, The Netherlands. Electronic address: mvandervalk@lumc.nl.'}, {'ForeName': 'Corrie A M', 'Initials': 'CAM', 'LastName': 'Marijnen', 'Affiliation': 'Department of Radiotherapy, Leiden University Medical Center, The Netherlands; Department of Radiotherapy, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Boudewijn', 'Initials': 'B', 'LastName': 'van Etten', 'Affiliation': 'Department of Surgery, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Esmée A', 'Initials': 'EA', 'LastName': 'Dijkstra', 'Affiliation': 'Department of Medical Oncology, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Denise E', 'Initials': 'DE', 'LastName': 'Hilling', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Elma Meershoek-Klein', 'Initials': 'EM', 'LastName': 'Kranenbarg', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Department of Medical Statistics, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Annet G H', 'Initials': 'AGH', 'LastName': 'Roodvoets', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Renu R', 'Initials': 'RR', 'LastName': 'Bahadoer', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Tone', 'Initials': 'T', 'LastName': 'Fokstuen', 'Affiliation': 'Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Albert Jan', 'Initials': 'AJ', 'LastName': 'Ten Tije', 'Affiliation': 'Department of Medical Oncology, Amphia Hospital, Breda, The Netherlands.'}, {'ForeName': 'Jaume', 'Initials': 'J', 'LastName': 'Capdevila', 'Affiliation': 'Department of Medical Oncology, Vall Hebron University Hospital, Vall Hebron Institute of Oncology (VHIO). Barcelona, Spain.'}, {'ForeName': 'Mathijs P', 'Initials': 'MP', 'LastName': 'Hendriks', 'Affiliation': 'Department of Medical Oncology, Northwest Clinics, Alkmaar, The Netherlands.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Edhemovic', 'Affiliation': 'Department of Surgical Oncology, Institute of Oncology Ljubljana, Slovenia.'}, {'ForeName': 'Andrès M R', 'Initials': 'AMR', 'LastName': 'Cervantes', 'Affiliation': 'Department of Medical Oncology, Hospital Clínico Universitario de Valencia, Spain.'}, {'ForeName': 'Derk Jan A', 'Initials': 'DJA', 'LastName': 'de Groot', 'Affiliation': 'Department of Medical Oncology, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Per J', 'Initials': 'PJ', 'LastName': 'Nilsson', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Glimelius', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Uppsala University, Sweden.'}, {'ForeName': 'Cornelis J H', 'Initials': 'CJH', 'LastName': 'van de Velde', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Geke A P', 'Initials': 'GAP', 'LastName': 'Hospers', 'Affiliation': 'Department of Medical Oncology, University of Groningen, University Medical Center Groningen, The Netherlands. Electronic address: g.a.p.hospers@umcg.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.03.011']
396,31034102,Expectations influence treatment outcomes in patients with low back pain. A secondary analysis of data from a randomized clinical trial.,"BACKGROUND


Low back pain (LBP) is a global public health challenge, which causes high healthcare costs and the highest burden on society in terms of years lived with disability. While patients' expectations for improvement may have effects on LBP treatment outcomes, it remains unclear if psychological profiles modify this relationship. Therefore, the objectives of this study were to investigate if (a) patients' expectations predicted short-term outcome, and (b) psychological profile, pain intensity and self-rated health modified the relationship between expectations and outcome.
METHODS


Data were collected between April 2012 and January 2016 during the inclusion into a randomized controlled trial. Potentially eligible participants were identified through 40 chiropractic clinics located across Sweden. Patients' expectations, psychological profile, pain intensity, activity limitation and self-rated health were collected from patients with recurrent persistent LBP during their first chiropractic visit (n = 593). Subjective improvement was measured at the fourth visit.
RESULTS


Patients with a high expectation of improvement had 58% higher risk to report an improvement at the fourth visit (RR = 1.58, 95% CI: 1.28, 1.95). Controlling for potential confounders only slightly decreased the strength of this association (RR = 1.49, 95% CI: 1.20, 1.86). Baseline pain intensity, psychological profile and self-rated health did not modify the effect of expectation on outcome.
CONCLUSIONS


Baseline patients' expectations play an important role when predicting LBP treatment outcomes. Clinicians should consider and address patients' expectations at the first visit to best inform prognosis.
SIGNIFICANCE


This study confirms the importance of patients' expectations in a clinical setting. Patients' expectations predict the short-term outcome of chiropractic care for LBP. Pain intensity, psychological profile and self-rated health did not modify this relationship.",2019,"Baseline pain intensity, psychological profile and self-rated health did not modify the effect of expectation on outcome.
","['Data were collected between April 2012 and January 2016 during the inclusion into a randomized controlled trial', 'patients with low back pain', 'Potentially eligible participants were identified through 40 chiropractic clinics located across Sweden']",[],"['Subjective improvement', 'Pain intensity, psychological profile and self-rated health', ""Patients' expectations, psychological profile, pain intensity, activity limitation and self-rated health"", 'Baseline pain intensity, psychological profile and self-rated health']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0008138', 'cui_str': 'Chiropractic'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]",[],"[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}]",,0.130218,"Baseline pain intensity, psychological profile and self-rated health did not modify the effect of expectation on outcome.
","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Eklund', 'Affiliation': 'Unit of Intervention and Implementation Research for Worker Health, The Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'De Carvalho', 'Affiliation': ""Discipline of Medicine, Faculty of Medicine, Memorial University of Newfoundland, St. John's, Newfoundland and Labrador, Canada.""}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Pagé', 'Affiliation': 'Department of Anatomy, Université du Québec à Trois-Rivières, Trois-Rivières, Québec, Canada.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong SAR, China.'}, {'ForeName': 'Melker S', 'Initials': 'MS', 'LastName': 'Johansson', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Pohlman', 'Affiliation': 'Research Institute, Parker University, Dallas, Texas.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hartvigsen', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Swain', 'Affiliation': 'Department of Chiropractic, Faculty of Science and Engineering, Macquarie University, Sydney, Australia.'}]","European journal of pain (London, England)",['10.1002/ejp.1407']
397,31902327,Clinical and Biomarker Predictors of Expanded Heart Failure Outcomes in Patients With Type 2 Diabetes Mellitus After a Recent Acute Coronary Syndrome: Insights From the EXAMINE Trial.,"Background Improved heart failure (HF) risk stratification after a recent acute coronary syndrome may identify those who can benefit from therapies that reduce HF risk. We aimed to identify clinical and biomarker predictors for expanded HF outcomes in patients with type 2 diabetes mellitus after recent acute coronary syndrome. Methods and Results The EXAMINE (Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care) trial was a multicenter, non-inferiority, double-masked, placebo-controlled study which randomized 5380 patients with type 2 diabetes mellitus after recent acute coronary syndrome to alogliptin or placebo. Baseline biomarkers were measured in 5154 patients: NT-proBNP (N-terminal pro-B-type natriuretic peptide), high-sensitivity troponin I, adiponectin, growth-differentiation-factor-15, and galectin-3. Our primary outcome was cardiovascular) death, HF hospitalization, elevated NT-proBNP during follow-up, or loop diuretics initiation. The association between clinical variables, biomarkers, and outcomes were assessed using Cox regression models. In the study population, the median age was 61.0 years, 67.7% were men, and 28.0% had baseline HF (median follow-up was 18 months). In multivariable analyses, NT-proBNP had the strongest association with the primary outcome (per log 2 , hazard ratio 1.24; Wald χ 2  67.4;  P <0.0001) followed by a prior HF history (hazard ratio 1.42; Wald χ 2  20.8;  P <0.0001). A model with clinical variables and biomarkers allowed for risk prediction for expanded HF outcomes (C-statistic=0.72). Discrimination results were similar for cardiovascular death or HF hospitalization. Conclusions Among patients with type 2 diabetes mellitus after recent acute coronary syndrome, the use biomarkers such as N-terminal pro-B-type natriuretic peptide and clinical variables enables risk stratification for expanded HF outcomes. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT00968708.",2020,"In multivariable analyses, NT-proBNP had the strongest association with the primary outcome (per log 2 , hazard ratio 1.24; Wald χ 2  67.4;  P <0.0001) followed by a prior HF history (hazard ratio 1.42; Wald χ 2  20.8;  P <0.0001).","['5154 patients: NT-proBNP', 'patients with type 2 diabetes mellitus after recent acute coronary syndrome', '5380 patients with type 2 diabetes mellitus after recent acute coronary syndrome to alogliptin or', 'In the study population, the median age was 61.0\xa0years, 67.7% were men, and 28.0% had baseline HF (median follow-up was 18\xa0months', 'Patients With Type 2 Diabetes Mellitus']","['Alogliptin versus Standard of Care', 'placebo']","['high-sensitivity troponin', 'cardiovascular death or HF hospitalization', 'cardiovascular) death, HF hospitalization, elevated NT-proBNP during follow-up, or loop diuretics initiation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C1958126', 'cui_str': 'alogliptin'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C1958126', 'cui_str': 'alogliptin'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0523952', 'cui_str': 'Troponin measurement'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0354100', 'cui_str': 'Loop Diuretics'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}]",5380.0,0.426068,"In multivariable analyses, NT-proBNP had the strongest association with the primary outcome (per log 2 , hazard ratio 1.24; Wald χ 2  67.4;  P <0.0001) followed by a prior HF history (hazard ratio 1.42; Wald χ 2  20.8;  P <0.0001).","[{'ForeName': 'Abhinav', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'INSERM CIC 1433 NI-CRCT (Cardiovascular and Renal Clinical Trialists) F-CRIN network Université de Lorraine and CHRU Nancy France.'}, {'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center Harvard Medical School Boston MA.""}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': 'INSERM CIC 1433 NI-CRCT (Cardiovascular and Renal Clinical Trialists) F-CRIN network Université de Lorraine and CHRU Nancy France.'}, {'ForeName': 'Yuyin', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Baim Institute for Clinical Research Boston MA.'}, {'ForeName': 'George L', 'Initials': 'GL', 'LastName': 'Bakris', 'Affiliation': 'University of Chicago Medicine Chicago IL.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': 'Baim Institute for Clinical Research Boston MA.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'White', 'Affiliation': 'University of Connecticut School of Medicine Farmington CT.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': 'INSERM CIC 1433 NI-CRCT (Cardiovascular and Renal Clinical Trialists) F-CRIN network Université de Lorraine and CHRU Nancy France.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.012797']
398,31785015,"Virtual reality during pediatric vascular access: A pragmatic, prospective randomized, controlled trial.","BACKGROUND


Vascular access is a minor procedure that is associated with reported pain and fear in pediatric patients, often resulting in procedural incompliance. Virtual reality has been shown to be effective in adult populations for reducing pain and anxiety in various medical settings, although large studies are lacking in pediatrics.
AIMS


The primary aim was to determine whether pain would be reduced in pediatric patients using virtual reality undergoing vascular access. The four secondary aims measured patient fear, procedural compliance, satisfaction, and adverse events.
METHODS


A prospective, randomized, controlled trial was completed at a pediatric hospital, enrolling children 7-18 years old undergoing vascular access in a variety of clinical settings, randomized to virtual reality or standard of care. Pain scores were measured using a numeric pain faces scale. The secondary outcomes of patient fear, procedural compliance, satisfaction, and adverse events were measured with the Child Fear Scale, modified Induction Compliance Checklist, and satisfaction surveys, respectively. Chi-squared, t tests, and regression models were used to analyze the results.
RESULTS


The analysis included 106 patients in the virtual reality group and 114 in the control. There were no significant differences in postprocedure pain (VR group estimated 0.11 points lower, 95% confidence interval: 0.50 points lower to 0.28 points greater, P = .59), postprocedure fear (VR group estimated 0.05 points lower, 95% confidence interval: 0.23 points lower to 0.13 points greater), or compliance (adjusted odds ratio 2.31, 95% confidence interval: 0.96-5.56). Children in the virtual reality group were satisfied with the intervention. There were no adverse events.
CONCLUSION


This study demonstrates no reduction in pain while using Virtual reality (VR) across a heterogeneous pediatric inpatient population undergoing vascular access.",2020,"There were no significant differences in post-procedure pain (VR group estimated 0.11 points lower, 95% confidence interval: 0.50 points lower to 0.28 points greater, p=0.59), post-procedure fear (VR group estimated 0.05 points lower, 95% confidence interval: 0.23 points lower to 0.13 points greater) or compliance (adjusted odds ratio 2.31, 95% confidence interval: 0.96 to 5.56).","['pediatric patients using virtual reality undergoing vascular access', '106 patients in the virtual reality group and 114 in the control', 'heterogeneous pediatric inpatient population undergoing vascular access', 'pediatric hospital, enrolling children 7-18 years old undergoing vascular access in a variety of clinical settings, randomized to virtual reality or standard of care']",[],"['post-procedure fear', 'Child Fear Scale, modified induction compliance checklist, and satisfaction surveys', 'pain', 'Pain scores', 'patient fear, procedural compliance, satisfaction, and adverse events', 'numeric pain faces scale', 'post-procedure pain']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0303405', 'cui_str': '114In radioisotope'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}]",[],"[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0222045'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}]",106.0,0.343114,"There were no significant differences in post-procedure pain (VR group estimated 0.11 points lower, 95% confidence interval: 0.50 points lower to 0.28 points greater, p=0.59), post-procedure fear (VR group estimated 0.05 points lower, 95% confidence interval: 0.23 points lower to 0.13 points greater) or compliance (adjusted odds ratio 2.31, 95% confidence interval: 0.96 to 5.56).","[{'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Caruso', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Division of Pediatric Anesthesia, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Alexandria', 'Initials': 'A', 'LastName': 'George', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Division of Pediatric Anesthesia, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Menendez', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Division of Pediatric Anesthesia, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'De Souza', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Division of Pediatric Anesthesia, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Khoury', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Division of Pediatric Anesthesia, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Madison N', 'Initials': 'MN', 'LastName': 'Kist', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Division of Pediatric Anesthesia, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Samuel T', 'Initials': 'ST', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Division of Pediatric Anesthesia, Stanford University School of Medicine, Stanford, CA, USA.'}]",Paediatric anaesthesia,['10.1111/pan.13778']
399,32243609,The benefits of iron supplementation following blood donation vary with baseline iron status.,"Whole blood donation rapidly removes approximately 10% of a donor's blood volume and stimulates substantial changes in iron metabolism and erythropoiesis. We sought to identify donors who benefit from iron supplementation, describe the nature of the benefit, and define the time course for recovery from donation. Blood samples were collected over 24 weeks following whole blood donation from 193 participants, with 96 participants randomized to 37.5 mg daily oral iron. Changes in total body, red blood cell (RBC), and storage iron, hepcidin, erythropoietin, and reticulocyte count were modeled using semiparametric curves in a mixed model. and the changes were compared among six groups defined by baseline ferritin (<12; 12-50; ≥50 ng/mL) and iron supplementation. The effect of oral iron on storage and RBC iron recovery was minimal in donors with baseline ferritin ≥50 ng/mL, but sizeable when ferritin was <50 ng/mL. Iron initially absorbed went to RBC and storage iron pools when ferritin was <12 ng/mL but went mostly to RBCs when ferritin was ≥12 ng/mL. Donors with ferritin ≥12 ng/mL had a ""ripple"" increase in reticulocytes ~100 days after donation indicating physiological responses occur months following donation. Thus, iron supplements markedly enhance recovery from whole blood donation in donors with ferritin <50 ng/mL. However, full recovery from donation requires over 100 days when taking iron. The findings also highlight the value of the study of blood donors for understanding human hemoglobin and iron metabolism and their usefulness for future studies as additional biomarkers are discovered.",2020,"The effect of oral iron on storage and RBC iron recovery was minimal in donors with baseline ferritin ≥50 ng/mL, but sizeable when ferritin was <50 ng/mL. Iron initially absorbed went to RBC and storage iron pools when ferritin was <12 ng/mL but went mostly to RBCs when ferritin was ≥12 ng/mL. Donors with ferritin ≥12","['donors with baseline ferritin ≥50 ng/mL, but sizeable when ferritin was <50 ng/mL. Iron initially absorbed went to RBC and storage iron pools when ferritin was <12 ng/mL but went mostly to RBCs when ferritin was ≥12 ng/mL. Donors with ferritin ≥12', 'donors with ferritin <50 ng/mL']",['iron supplementation'],"['storage and RBC iron recovery', 'total body, RBC, and storage iron, hepcidin, erythropoietin, and reticulocyte count']","[{'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0014792', 'cui_str': 'erythrocytes'}]","[{'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}]","[{'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0206161', 'cui_str': 'Reticulocyte count'}]",96.0,0.117661,"The effect of oral iron on storage and RBC iron recovery was minimal in donors with baseline ferritin ≥50 ng/mL, but sizeable when ferritin was <50 ng/mL. Iron initially absorbed went to RBC and storage iron pools when ferritin was <12 ng/mL but went mostly to RBCs when ferritin was ≥12 ng/mL. Donors with ferritin ≥12","[{'ForeName': 'Alan E', 'Initials': 'AE', 'LastName': 'Mast', 'Affiliation': 'Blood Research Institute, Versiti, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Aniko', 'Initials': 'A', 'LastName': 'Szabo', 'Affiliation': 'Division of Biostatistics, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Mars', 'Initials': 'M', 'LastName': 'Stone', 'Affiliation': 'Vitalant Research Institute, San Francisco, California, USA.'}, {'ForeName': 'Ritchard G', 'Initials': 'RG', 'LastName': 'Cable', 'Affiliation': 'American Red Cross Scientific Affairs, Farmington, Connecticut, USA.'}, {'ForeName': 'Bryan R', 'Initials': 'BR', 'LastName': 'Spencer', 'Affiliation': 'American Red Cross Scientific Affairs, Dedham, Massachusetts, USA.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Kiss', 'Affiliation': 'Vitalant Northeast Division, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of hematology,['10.1002/ajh.25800']
400,31724337,Effects of dl-3-n-butylphthalide on serum lipoprotein-associated phospholipase A2 and hypersensitive C-reactive protein levels in acute cerebral infarction.,"OBJECTIVE


This study aims to explore the curative effect of dl-3-n-butylphthalide (NBP) on patients with acute cerebral infarction (ACI) and its effects on serum lipoprotein-associated phospholipase A2 (Lp-PLA2) and hypersensitive C-reactive protein (hs-CRP) levels.
METHODS


A total of 136 ACI patients treated in our hospital, who met the criteria, were selected and randomly divided into two groups: control group (n = 60, including 28 males and 32 females) and treatment group (n = 76, including 32 males and 44 females). Patients in the control group were treated with routine drug therapy, while patients in the treatment group were treated with NBP on this basis. A dose of 100 ml was administered by intravenous injection for 2 times/day, for 14 days. The curative effect was evaluated using the National Institute of Health Stroke Scale (NIHSS) and Barthel index (BI) self-care ability. The levels of the two factors in serum were measured using enzyme-linked immunosorbent assay, and the changes in levels of these two factors in serum at different time points before and after treatment were compared between the two groups.
RESULTS


(a) Lp-PLA2 and hs-CRP levels in the treatment group after treatment were significantly lower than those before treatment and those in the control group after treatment (p < .05). (b) The NIHSS and BI scores in the treatment group were significantly lower after treatment than before treatment and those in the control group after treatment (p < .05).
CONCLUSION


Dl-3-n-butylphthalide can improve the expression of Lp-PLA2 and hs-CRP in serum in ACI patients. Furthermore, NBP has significant efficacy in inhibiting inflammation and improving neurological symptoms.",2019,Dl-3-n-butylphthalide can improve the expression of Lp-PLA2 and hs-CRP in serum in ACI patients.,"['patients with acute cerebral infarction (ACI', 'acute cerebral infarction', '136 ACI patients treated in our hospital, who met the criteria, were selected and randomly divided into two groups: control group (n\xa0=\xa060, including 28 males and 32 females) and treatment group (n\xa0=\xa076, including 32 males and 44 females', 'ACI patients']","['NBP', 'dl-3-n-butylphthalide', 'routine drug therapy', 'dl-3-n-butylphthalide (NBP']","['NIHSS and BI scores', 'a) Lp-PLA2 and hs-CRP levels', 'National Institute of Health Stroke Scale (NIHSS) and Barthel index (BI) self-care ability', 'serum lipoprotein-associated phospholipase A2 (Lp-PLA2) and hypersensitive C-reactive protein (hs-CRP) levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007785', 'cui_str': 'Cerebral Infarction'}, {'cui': 'C0540404', 'cui_str': 'adenylyl cyclase type I'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0332286', 'cui_str': 'Into (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0047625', 'cui_str': '3-n-butylphthalide'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0914069', 'cui_str': '1-Alkyl-2-acetylglycerophosphocholine Esterase'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3472496', 'cui_str': 'National Institutes of Health stroke scale'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C0562734', 'cui_str': 'Ability to perform self-care activities'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0031667', 'cui_str': 'Lecithinase A2'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]",,0.0205239,Dl-3-n-butylphthalide can improve the expression of Lp-PLA2 and hs-CRP in serum in ACI patients.,"[{'ForeName': 'Xiao-Lei', 'Initials': 'XL', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurology, Shanxi People's Hospital, Taiyuan, China.""}, {'ForeName': 'Yin-Tao', 'Initials': 'YT', 'LastName': 'Dong', 'Affiliation': ""Department of Neurology, Shanxi People's Hospital, Taiyuan, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Neurology, Shanxi People's Hospital, Taiyuan, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurology, Shanxi People's Hospital, Taiyuan, China.""}, {'ForeName': 'Ting-Ting', 'Initials': 'TT', 'LastName': 'Li', 'Affiliation': ""Department of Neurology, Shanxi People's Hospital, Taiyuan, China.""}, {'ForeName': 'Feng-Yun', 'Initials': 'FY', 'LastName': 'Hu', 'Affiliation': ""Department of Neurology, Shanxi People's Hospital, Taiyuan, China.""}]",Brain and behavior,['10.1002/brb3.1469']
401,31763732,"Prospective, multicenter, randomized, controlled trial evaluating the performance of a novel combination powder vs hemostatic matrix in cardiothoracic operations.","AIM


This trial compared the hemostatic performance of a novel combination powder (CP) to a control hemostatic matrix (HM) in cardiothoracic operations.
METHODS


Patients meeting eligibility criteria were enrolled after providing informed consent. Subjects were randomized intraoperatively to receive CP (HEMOBLAST Bellows; Biom'up, France) or HM (FLOSEAL Hemostatic Matrix; Baxter Healthcare Corporation, Hayward, CA). Bleeding was assessed using a clinically validated, quantitative bleeding severity scale. The primary endpoint was total time to hemostasis (TTTH), from the start of device preparation, as an indicator of when a surgeon asks for a surgical hemostat until hemostasis was achieved. TTTH at 3 minutes was utilized for the primary analysis, while TTTH at 5 minutes was considered as a secondary endpoint.
RESULTS


A total of 105 subjects were enrolled across four institutions. The primary efficacy endpoint for the superiority of CP relative to HM for success at achieving hemostasis within 3 minutes was met, with 64.2% of the CP group achieving hemostasis compared with 9.6% of the HM group, a difference of 54.54% (37.4%-71.6%; P < .001 for superiority). The secondary efficacy endpoint was also met, with 92.5% of the CP group achieving hemostasis at 5 minutes versus 44.2% in the HM group, a difference of 48.2% (31.1%-65.4%; P < .001 for noninferiority). There were no device-related adverse events.
CONCLUSIONS


In this multicenter, randomized, controlled trial, comparison of CP to HM revealed CP superiority and noninferiority for TTTH at 3 and 5 minutes, respectively.",2020,"The primary efficacy endpoint for the superiority of CP relative to HM for success at achieving hemostasis within 3 minutes was met, with 64.2% of the CP group achieving hemostasis compared with 9.6% of the HM group, a difference of 54.54% (37.4%-71.6%; P < .001 for superiority).","['cardiothoracic operations', '105 subjects were enrolled across four institutions', 'Patients meeting eligibility criteria were enrolled after providing informed consent']","['CP', 'novel combination powder (CP', 'novel combination powder vs hemostatic matrix']","['Bleeding', 'total time to hemostasis (TTTH), from the start of device preparation, as an indicator of when a surgeon asks for a surgical hemostat until hemostasis', 'achieving hemostasis', 'superiority of CP relative to HM for success at achieving hemostasis']","[{'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]","[{'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0019120', 'cui_str': 'Hemostatics'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0180950', 'cui_str': 'Hemostat, device (physical object)'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}]",105.0,0.290589,"The primary efficacy endpoint for the superiority of CP relative to HM for success at achieving hemostasis within 3 minutes was met, with 64.2% of the CP group achieving hemostasis compared with 9.6% of the HM group, a difference of 54.54% (37.4%-71.6%; P < .001 for superiority).","[{'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Dang', 'Affiliation': 'Department of Surgery, Kaiser Moanalua Medical Center, Honolulu, Hawaii.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Ardehali', 'Affiliation': 'Department of Surgery, University of California at Los Angeles, Los Angeles, California.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Bruckner', 'Affiliation': 'Methodist DeBakey Heart and Vascular Center, Houston Methodist Hospital, Houston, Texas.'}, {'ForeName': 'Patrick E', 'Initials': 'PE', 'LastName': 'Parrino', 'Affiliation': 'Thoracic and Cardiovascular Surgery Section, Ochsner Medical Center, New Orleans, Louisiana.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Gillen', 'Affiliation': 'Department of Statistics, University of California, Irvine, California.'}, {'ForeName': 'Rachel W', 'Initials': 'RW', 'LastName': 'Hoffman', 'Affiliation': ""Biom'up SA, Lyon, France.""}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Spotnitz', 'Affiliation': ""Biom'up SA, Lyon, France.""}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Cavoores', 'Affiliation': ""Biom'up SA, Lyon, France.""}, {'ForeName': 'Ian J', 'Initials': 'IJ', 'LastName': 'Shorn', 'Affiliation': ""Biom'up SA, Lyon, France.""}, {'ForeName': 'Roberto J', 'Initials': 'RJ', 'LastName': 'Manson', 'Affiliation': ""Biom'up SA, Lyon, France.""}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Spotnitz', 'Affiliation': ""Biom'up SA, Lyon, France.""}]",Journal of cardiac surgery,['10.1111/jocs.14376']
402,31131629,Effects of Extended-Release Niacin on Quartile Lp-PLA 2  Levels and Clinical Outcomes in Statin-treated Patients with Established Cardiovascular Disease and Low Baseline Levels of HDL-Cholesterol: Post Hoc Analysis of the AIM HIGH Trial.,"BACKGROUND


Lipoprotein-associated phospholipase A 2  (LpPLA 2 ) is an inflammatory marker that has been associated with the presence of vulnerable plaque and increased risk of cardiovascular (CV) events.
OBJECTIVE


To assess the effect of extended-release niacin (ERN) on Lp-PLA 2  activity and clinical outcomes.
METHODS


We performed a post hoc analysis in 3196 AIM-HIGH patients with established CV disease and low baseline levels of high-density lipoprotein cholesterol (HDL-C) who were randomized to ERN versus placebo on a background of simvastatin therapy (with or without ezetimibe) to assess the association between baseline Lp-PLA 2  activity and the rate of the composite primary end point (CV death, myocardial infarction, stroke, hospitalization for unstable angina, and symptom-driven revascularization).
RESULTS


Participants randomized to ERN, but not those randomized to placebo, experienced a significant 8.9% decrease in LpPLA 2 . In univariate analysis, the highest quartile of LpPLA 2  activity (>208 nmol/min/mL, Q4) was associated with higher event rates compared to the lower quartiles in the placebo group (log rank  P  = .032), but not in the ERN treated participants (log rank  P  = .718). However, in multivariate analysis, adjusting for sex, diabetes, baseline LDL-C, HDL-C, and triglycerides, there was no significant difference in outcomes between the highest Lp-PLA2 activity quartile versus the lower quartiles in both the placebo and the ERN groups.
CONCLUSION


Among participants with stable CV disease on optimal medical therapy, elevated Lp-PLA 2  was associated with higher CV events; however, addition of ERN mitigates this effect. This association in the placebo group was attenuated after multivariable adjustment, which suggests that Lp-PLA 2  does not improve risk assessment beyond traditional risk factors.",2019,"RESULTS


Participants randomized to ERN, but not those randomized to placebo, experienced a significant 8.9% decrease in LpPLA 2 .","['Statin-treated Patients with Established Cardiovascular Disease and Low Baseline Levels of HDL-Cholesterol', 'participants with stable CV disease on optimal medical therapy, elevated Lp', '3196 AIM-HIGH patients with established CV disease and low baseline levels of high-density lipoprotein cholesterol (HDL-C']","['Lipoprotein-associated phospholipase', 'ERN versus placebo', 'ERN', 'placebo', 'extended-release niacin (ERN', 'Extended-Release Niacin', 'simvastatin therapy (with or without ezetimibe']","['rate of the composite primary end point (CV death, myocardial infarction, stroke, hospitalization for unstable angina, and symptom-driven revascularization', 'LpPLA 2 ', 'highest Lp-PLA2 activity quartile', 'risk assessment beyond traditional risk factors', 'Quartile Lp-PLA 2  Levels and Clinical Outcomes']","[{'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}]","[{'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0031671', 'cui_str': 'Lecithinases'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0027996', 'cui_str': 'Niacin'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0914069', 'cui_str': '1-Alkyl-2-acetylglycerophosphocholine Esterase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment (procedure)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",,0.498581,"RESULTS


Participants randomized to ERN, but not those randomized to placebo, experienced a significant 8.9% decrease in LpPLA 2 .","[{'ForeName': 'Radmila', 'Initials': 'R', 'LastName': 'Lyubarova', 'Affiliation': '1 Division of Cardiology, Albany Medical Center, Albany Medical College, Albany, NY, USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Albers', 'Affiliation': '2 University of Washington, Northwest Lipid Metabolism, And Diabetes Research Laboratories, Seattle, WA, USA.'}, {'ForeName': 'Santica M', 'Initials': 'SM', 'LastName': 'Marcovina', 'Affiliation': '2 University of Washington, Northwest Lipid Metabolism, And Diabetes Research Laboratories, Seattle, WA, USA.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': '3 Axio Research LLC, Seattle, WA, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'McBride', 'Affiliation': '3 Axio Research LLC, Seattle, WA, USA.'}, {'ForeName': 'Alexandru', 'Initials': 'A', 'LastName': 'Topliceanu', 'Affiliation': '4 Division of Cardiology, Albany Medical Center, Albany Medical College, Albany, NY, USA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Anderson', 'Affiliation': '5 University of Calgary and Libin Cardiovascular Institute, Foothills Medical Centre, Calgary, Canada.'}, {'ForeName': 'Jerome L', 'Initials': 'JL', 'LastName': 'Fleg', 'Affiliation': '6 National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': '6 National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Moti L', 'Initials': 'ML', 'LastName': 'Kashyap', 'Affiliation': '7 VA Long Beach Healthcare System, Long Beach, CA, USA.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'McGovern', 'Affiliation': '8 Miami Beach, FL, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Boden', 'Affiliation': '9 New England Healthcare System, Boston, MA, USA.'}]",Journal of cardiovascular pharmacology and therapeutics,['10.1177/1074248419852955']
403,32145111,c-MYC expression and maturity phenotypes are associated with outcome benefit from addition of ixazomib to lenalidomide-dexamethasone in myeloma.,"OBJECTIVES


In the TOURMALINE-MM1 phase 3 trial in relapsed/refractory multiple myeloma, ixazomib-lenalidomide-dexamethasone (IRd) showed different magnitudes of progression-free survival (PFS) benefit vs placebo-Rd according to number and type of prior therapies, with greater benefit seen in patients with >1 prior line of therapy or 1 prior line of therapy without stem cell transplantation (SCT).
METHODS


RNA sequencing data were used to investigate the basis of these differences.
RESULTS


The PFS benefit of IRd vs placebo-Rd was greater in patients with tumors expressing high c-MYC levels (median not reached vs 11.3 months; hazard ratio [HR] 0.42; 95% CI, 0.26, 0.66; P < .001) compared with in those expressing low c-MYC levels (median 20.6 vs 16.6 months; HR 0.75; 95% CI, 0.42, 1.2). Expression of c-MYC in tumors varied based on the number and type of prior therapy received, with the lowest levels observed in tumors of patients who had received 1 prior line of therapy including SCT. These tumors also had higher expression levels of CD19 and CD81.
CONCLUSIONS


PFS analyses suggest that lenalidomide and ixazomib target tumors with different levels of c-MYC, CD19, and CD81 expression, thus providing a potential rationale for the differential benefits observed in the TOURMALINE-MM1 study. This trial was registered at www.clinicaltrials.gov as: NCT01564537.",2020,"Expression of c-MYC in tumors varied based on the number and type of prior therapy received, with the lowest levels observed in tumors of patients who had received 1 prior line of therapy including SCT.",['patients with >1 prior line of therapy or 1 prior line of therapy without stem cell transplantation (SCT'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4280965', 'cui_str': '>1'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}]",[],[],,0.125194,"Expression of c-MYC in tumors varied based on the number and type of prior therapy received, with the lowest levels observed in tumors of patients who had received 1 prior line of therapy including SCT.","[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Di Bacco', 'Affiliation': 'Millennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited), Cambridge, MA, USA.'}, {'ForeName': 'Nizar J', 'Initials': 'NJ', 'LastName': 'Bahlis', 'Affiliation': 'Southern Alberta Cancer Research Institute, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Nikhil C', 'Initials': 'NC', 'LastName': 'Munshi', 'Affiliation': 'Hematologic Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Avet-Loiseau', 'Affiliation': 'Hematology, IUC-Oncopole, Toulouse, France.'}, {'ForeName': 'Tamás', 'Initials': 'T', 'LastName': 'Masszi', 'Affiliation': 'Department of Haematology and Stem Cell Transplantation, St. István and St. László Hospital of Budapest, Budapest, Hungary.'}, {'ForeName': 'Luísa', 'Initials': 'L', 'LastName': 'Viterbo', 'Affiliation': 'Instituto Português de Oncologia do Porto Francisco Gentil, Entidade Pública Empresarial (IPOPFG, EPE), Porto, Portugal.'}, {'ForeName': 'Ludek', 'Initials': 'L', 'LastName': 'Pour', 'Affiliation': 'Hematology and Oncology, University Hospital Brno, Brno, Czech Republic.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ganly', 'Affiliation': 'Department of Haematology, Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': 'Institute of Hematology and Medical Oncology ""Seràgnoli"", Bologna University School of Medicine, S.Orsola\'s University Hospital, Bologna, Italy.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Langer', 'Affiliation': 'University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Shaji K', 'Initials': 'SK', 'LastName': 'Kumar', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'S Vincent', 'Initials': 'SV', 'LastName': 'Rajkumar', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Jonathan J', 'Initials': 'JJ', 'LastName': 'Keats', 'Affiliation': 'Translational Genomics Research Institute (TGEN), Phoenix, AZ, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Berg', 'Affiliation': 'Millennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited), Cambridge, MA, USA.'}, {'ForeName': 'Jianchang', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Millennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited), Cambridge, MA, USA.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Millennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited), Cambridge, MA, USA.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Badola', 'Affiliation': 'Millennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited), Cambridge, MA, USA.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Millennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited), Cambridge, MA, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Millennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited), Cambridge, MA, USA.'}, {'ForeName': 'Dixie-Lee', 'Initials': 'DL', 'LastName': 'Esseltine', 'Affiliation': 'Millennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited), Cambridge, MA, USA.'}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Luptakova', 'Affiliation': 'Millennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited), Cambridge, MA, USA.'}, {'ForeName': 'Helgi', 'Initials': 'H', 'LastName': 'van de Velde', 'Affiliation': 'Millennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited), Cambridge, MA, USA.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Richardson', 'Affiliation': 'Hematologic Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'Department of Hematology, University Hospital Hôtel Dieu, University of Nantes, Nantes, France.'}]",European journal of haematology,['10.1111/ejh.13405']
404,31035775,Ticagrelor Does Not Improve Endothelial Dysfunction in Stable Survivors of Acute Coronary Syndrome.,"BACKGROUND


Ticagrelor is an intriguing antiplatelet agent with a potentially beneficial impact on endothelial dysfunction and confers a mortality benefit beyond 1 month after acute coronary syndrome (ACS). However, little data exist on whether ticagrelor improves endothelial dysfunction in stable patients who survive the acute period and receive guideline-directed medical therapy.
METHODS AND RESULTS


This study is a prospective, randomized, parallel, open-labeled study that enrolled 30-day survivors of non-ST-segment elevation ACS (NSTE-ACS). Forty patients with NSTE-ACS were randomly assigned to ticagrelor or clopidogrel groups. The primary end point was the change in the percentage brachial artery flow-mediated dilation (baFMD) from baseline. Baseline characteristics were not different between the 2 groups. The median time from the stent implantation to screening was 269 days. After 30 days of study medication administration, the change in the percentage baFMD value was similar between the ticagrelor and clopidogrel groups (-0.08 [1.42] vs 0.30 [1.69],  P  = .66). There was no difference in the change in high-sensitive C-reactive protein (-0.61 [1.48] vs -0.01 [0.57],  P  = .28); however, the change in platelet inhibition significantly differed (P2Y 12  reaction units, -140.5 [49.5] vs -3.9 [51.4],  P  < .001).
CONCLUSIONS


This dual time point baFMD study demonstrated that treatment with ticagrelor was not superior to clopidogrel for improving endothelial dysfunction in stabilized patients with NSTE-ACS.",2019,"There was no difference in the change in high-sensitive C-reactive protein (-0.61 [1.48] vs -0.01 [0.57], P = .28); however, the change in platelet inhibition significantly differed (P2Y 12  reaction units, -140.5","['enrolled 30-day survivors of non-ST-segment elevation ACS (NSTE-ACS', 'stable patients who survive the acute period and receive guideline-directed medical therapy', 'Forty patients with NSTE-ACS', 'Stable Survivors of Acute Coronary Syndrome', 'stabilized patients with NSTE-ACS']","['Ticagrelor', 'ticagrelor', 'clopidogrel', 'ticagrelor or clopidogrel']","['high-sensitive C-reactive protein', 'endothelial dysfunction', 'percentage baFMD value', 'platelet inhibition', 'median time', 'percentage brachial artery flow-mediated dilation (baFMD', 'Endothelial Dysfunction']","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation (finding)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0006087', 'cui_str': 'Brachial Artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}]",40.0,0.0510088,"There was no difference in the change in high-sensitive C-reactive protein (-0.61 [1.48] vs -0.01 [0.57], P = .28); however, the change in platelet inhibition significantly differed (P2Y 12  reaction units, -140.5","[{'ForeName': 'Sungmin', 'Initials': 'S', 'LastName': 'Lim', 'Affiliation': '1 Division of Cardiology, Cardiovascular Center, Mediplex Sejong Hospital, Incheon, Republic of Korea.'}, {'ForeName': 'Eun Ho', 'Initials': 'EH', 'LastName': 'Choo', 'Affiliation': ""2 Division of Cardiology, Department of Internal Medicine, Uijeongbu St Mary's Hospital, College of Medicine, The Catholic University of Korea, Uijeongbu, Republic of Korea.""}, {'ForeName': 'Chan Joon', 'Initials': 'CJ', 'LastName': 'Kim', 'Affiliation': ""2 Division of Cardiology, Department of Internal Medicine, Uijeongbu St Mary's Hospital, College of Medicine, The Catholic University of Korea, Uijeongbu, Republic of Korea.""}, {'ForeName': 'Ik Jun', 'Initials': 'IJ', 'LastName': 'Choi', 'Affiliation': ""3 Division of Cardiology, Department of Internal Medicine, Incheon St Mary's Hospital, College of Medicine, The Catholic University of Korea, Incheon, Republic of Korea.""}, {'ForeName': 'Kwan Yong', 'Initials': 'KY', 'LastName': 'Lee', 'Affiliation': ""3 Division of Cardiology, Department of Internal Medicine, Incheon St Mary's Hospital, College of Medicine, The Catholic University of Korea, Incheon, Republic of Korea.""}, {'ForeName': 'Byung-Hee', 'Initials': 'BH', 'LastName': 'Hwang', 'Affiliation': ""4 Division of Cardiology, Department of Internal Medicine, St Paul's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Jong-Min', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': ""2 Division of Cardiology, Department of Internal Medicine, Uijeongbu St Mary's Hospital, College of Medicine, The Catholic University of Korea, Uijeongbu, Republic of Korea.""}, {'ForeName': 'Wook Sung', 'Initials': 'WS', 'LastName': 'Chung', 'Affiliation': ""5 Division of Cardiology, Department of Internal Medicine, Seoul St Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Kiyuk', 'Initials': 'K', 'LastName': 'Chang', 'Affiliation': ""5 Division of Cardiology, Department of Internal Medicine, Seoul St Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}]",Journal of cardiovascular pharmacology and therapeutics,['10.1177/1074248419841640']
405,31419323,Efficacy and safety of HAT1 compared with calcipotriol in the treatment of patients with mild to moderate chronic plaque psoriasis: results from an open-label randomized comparative pilot clinical study.,"Psoriasis is commonly treated with topical corticosteroids, oral cytotoxic drugs and biologic agents, which can be associated with significant adverse effects (AEs), high cost and response attenuation. Additionally, patients often use alternative therapies ad hoc, which can be challenging to integrate into a treatment regimen, owing to a lack of adequately powered controlled trials assessing efficacy and safety. We developed a novel topical botanical complex, herbal anti-inflammatory treatment (HAT1), through extensive preclinical in vitro and in vivo modelling to define key mechanisms of action and clinical potential. To assess the efficacy and safety of HAT1 in psoriasis, we performed a 10-week, open-label, pilot clinical trial comparing topical treatment of HAT1 with calcipotriol 0.005% in adult patients with mild to moderate psoriasis. Primary and secondary endpoints included the percentage of patients obtaining improvement of ≥ 75% in Psoriasis Area and Severity Index (PASI 75), Physician's Global Assessment (PGA) response, and evaluation of tolerability and safety of HAT1. In the HAT1 arm, 85.7% of study patients reached PASI 75 compared with 21.4% in the calcipotriol comparator group. Additionally, 78.6% of patients in the HAT1 arm achieved a 'clear' or 'minimal' PGA response. HAT1 was well tolerated, with no AEs observed throughout the trial. These results suggest that HAT1 reduces psoriasis disease activity in a clinically relevant manner. Ongoing studies, including well-powered, double-blind, randomized controlled trials will be required to assess the potential of HAT1 in psoriasis.",2020,In the HAT1 arm 85.7% of study patients reached a PASI 75 compared to 21.4% in the calcipotriol comparator group.,"['patients with mild-to-moderate chronic plaque psoriasis', 'adult mild to moderate psoriasis patients']","['HAT1 to 0.005% calcipotriol', 'calcipotriol', 'HAT1']","['clear"" or ""minimal"" PGA response', 'Efficacy and safety', 'efficacy and safety', 'percentage of patients obtaining PASI improvement of 75% or greater (PASI 75), PGA response, and evaluation of tolerability and safety of HAT1', 'psoriasis disease activity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C4517389', 'cui_str': '0.005'}, {'cui': 'C0065767', 'cui_str': 'calcipotriol'}]","[{'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",,0.0666339,In the HAT1 arm 85.7% of study patients reached a PASI 75 compared to 21.4% in the calcipotriol comparator group.,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Alex', 'Affiliation': 'Haus Clinical Research Program, Haus Bioceuticals, Oklahoma City, OK, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': 'Haus Clinical Research Program, Haus Bioceuticals, Oklahoma City, OK, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Sutton', 'Affiliation': 'Haus Clinical Research Program, Haus Bioceuticals, Oklahoma City, OK, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Yesudas', 'Affiliation': 'Haus Clinical Research Program, Haus Bioceuticals, Oklahoma City, OK, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sutton', 'Affiliation': 'Haus Clinical Research Program, Haus Bioceuticals, Oklahoma City, OK, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': 'Haus Clinical Research Program, Haus Bioceuticals, Oklahoma City, OK, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Centola', 'Affiliation': 'Haus Clinical Research Program, Haus Bioceuticals, Oklahoma City, OK, USA.'}]",Clinical and experimental dermatology,['10.1111/ced.14074']
406,31315612,"Intensive virtual reality and robotic based upper limb training compared to usual care, and associated cortical reorganization, in the acute and early sub-acute periods post-stroke: a feasibility study.","BACKGROUND


There is conflict regarding the benefits of greater amounts of intensive upper limb rehabilitation in the early period post-stroke. This study was conducted to test the feasibility of providing intensive therapy during the early period post-stroke and to develop a randomized control trial that is currently in process. Specifically, the study investigated whether an additional 8 h of specialized, intensive (200-300 separate hand or arm movements per hour) virtual reality (VR)/robotic based upper limb training introduced within 1-month post-stroke resulted in greater improvement in impairment and behavior, and distinct changes in cortical reorganization measured via Transcranial Magnetic Stimulation (TMS), compared to that of a control group.
METHODS


Seven subjects received 8-1 h sessions of upper limb VR/robotic training in addition to their inpatient therapy (PT, OT, ST). Six subjects only received their inpatient therapy. All were tested on measures of impairment [Upper Extremity Fugl-Meyer Assessment (UEFMA), Wrist AROM, Maximum Pinch Force], behavior [Wolf Motor Function Test (WMFT)], and also received TMS mapping until 6 months post training. ANOVAs were conducted to measure differences between groups across time for all outcome measures. Associations between changes in ipsilesional cortical maps during the early period of enhanced neuroplasticity and long-term changes in upper limb impairment and behavior measures were evaluated.
RESULTS


The VR/robotic group made significantly greater improvements on UEFMA and Wrist AROM scores compared to the usual care group. There was also less variability in the association between changes in the First Dorsal Interosseus (FDI) muscle map area and WMFT and Maximum Force change scores for the VR/robotic group.
CONCLUSIONS


An additional 8 h of intensive VR/robotic based upper limb training initiated within the first month post-stroke may promote greater gains in impairment compared to usual care alone. Importantly, the data presented demonstrated the feasibility of conducting this intervention and multiple outcome measures (impairment, behavioral, neurophysiological) in the early period post-stroke.",2019,The VR/robotic group made significantly greater improvements on UEFMA and Wrist AROM scores compared to the usual care group.,['Seven subjects received'],"['8-1\u2009h sessions of upper limb VR/robotic training in addition to their inpatient therapy (PT, OT, ST', 'intensive therapy', 'intensive VR/robotic based upper limb training', 'additional 8\u2009h of specialized, intensive (200-300 separate hand or arm movements per hour) virtual reality (VR)/robotic based upper limb training', 'Intensive virtual reality and robotic based upper limb training compared to usual care, and associated cortical reorganization']","['UEFMA and Wrist AROM scores', 'impairment [Upper Extremity Fugl-Meyer Assessment (UEFMA), Wrist AROM, Maximum Pinch Force], behavior [Wolf Motor Function Test (WMFT', 'impairment and behavior, and distinct changes in cortical reorganization measured via Transcranial Magnetic Stimulation (TMS', 'First Dorsal Interosseus (FDI) muscle map area and WMFT and Maximum Force change scores']","[{'cui': 'C0205453', 'cui_str': '7'}]","[{'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0556501', 'cui_str': 'Upper limb training (procedure)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0564385', 'cui_str': 'per hour'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0418416', 'cui_str': 'Pinched (event)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0325001', 'cui_str': 'Wolves'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",300.0,0.0240431,The VR/robotic group made significantly greater improvements on UEFMA and Wrist AROM scores compared to the usual care group.,"[{'ForeName': 'Jigna', 'Initials': 'J', 'LastName': 'Patel', 'Affiliation': 'Department of Rehabilitation and Movement Sciences, School of Health Professions, Rutgers University, The State University of New Jersey, 65 Bergen Street, Newark, NJ, 07107, USA. patel421@shp.rutgers.edu.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Fluet', 'Affiliation': 'Department of Rehabilitation and Movement Sciences, School of Health Professions, Rutgers University, The State University of New Jersey, 65 Bergen Street, Newark, NJ, 07107, USA.'}, {'ForeName': 'Qinyin', 'Initials': 'Q', 'LastName': 'Qiu', 'Affiliation': 'Department of Rehabilitation and Movement Sciences, School of Health Professions, Rutgers University, The State University of New Jersey, 65 Bergen Street, Newark, NJ, 07107, USA.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Yarossi', 'Affiliation': 'Movement Neuroscience Laboratory, Department of Physical Therapy, Bouve College of Health Sciences, Movement and Rehabilitation Science, Northeastern University, 308C Robinson Hall - 360 Huntington Avenue, Boston, MA, 02115, USA.'}, {'ForeName': 'Alma', 'Initials': 'A', 'LastName': 'Merians', 'Affiliation': 'Department of Rehabilitation and Movement Sciences, School of Health Professions, Rutgers University, The State University of New Jersey, 65 Bergen Street, Newark, NJ, 07107, USA.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Tunik', 'Affiliation': 'Movement Neuroscience Laboratory, Department of Physical Therapy, Bouve College of Health Sciences, Movement and Rehabilitation Science, Northeastern University, 308C Robinson Hall - 360 Huntington Avenue, Boston, MA, 02115, USA.'}, {'ForeName': 'Sergei', 'Initials': 'S', 'LastName': 'Adamovich', 'Affiliation': 'Department of Biomedical Engineering, New Jersey Institute of Technology, 616 Fenster Hall - 323 Dr. MLK Jr. BLVD, Newark, NJ, 07102, USA.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-019-0563-3']
407,31751012,"Overall Survival with Osimertinib in Untreated,  EGFR -Mutated Advanced NSCLC.","BACKGROUND


Osimertinib is a third-generation, irreversible tyrosine kinase inhibitor of the epidermal growth factor receptor (EGFR-TKI) that selectively inhibits both EGFR-TKI-sensitizing and  EGFR  T790M resistance mutations. A phase 3 trial compared first-line osimertinib with other EGFR-TKIs in patients with  EGFR  mutation-positive advanced non-small-cell lung cancer (NSCLC). The trial showed longer progression-free survival with osimertinib than with the comparator EGFR-TKIs (hazard ratio for disease progression or death, 0.46). Data from the final analysis of overall survival have not been reported.
METHODS


In this trial, we randomly assigned 556 patients with previously untreated advanced NSCLC with an  EGFR  mutation (exon 19 deletion or L858R allele) in a 1:1 ratio to receive either osimertinib (80 mg once daily) or one of two other EGFR-TKIs (gefitinib at a dose of 250 mg once daily or erlotinib at a dose of 150 mg once daily, with patients receiving these drugs combined in a single comparator group). Overall survival was a secondary end point.
RESULTS


The median overall survival was 38.6 months (95% confidence interval [CI], 34.5 to 41.8) in the osimertinib group and 31.8 months (95% CI, 26.6 to 36.0) in the comparator group (hazard ratio for death, 0.80; 95.05% CI, 0.64 to 1.00; P = 0.046). At 3 years, 79 of 279 patients (28%) in the osimertinib group and 26 of 277 (9%) in the comparator group were continuing to receive a trial regimen; the median exposure was 20.7 months and 11.5 months, respectively. Adverse events of grade 3 or higher were reported in 42% of the patients in the osimertinib group and in 47% of those in the comparator group.
CONCLUSIONS


Among patients with previously untreated advanced NSCLC with an  EGFR  mutation, those who received osimertinib had longer overall survival than those who received a comparator EGFR-TKI. The safety profile for osimertinib was similar to that of the comparator EGFR-TKIs, despite a longer duration of exposure in the osimertinib group. (Funded by AstraZeneca; FLAURA ClinicalTrials.gov number, NCT02296125.).",2020,"The median overall survival was 38.6 months (95% confidence interval [CI], 34.5 to 41.8) in the osimertinib group and 31.8 months (95% CI, 26.6 to 36.0) in the comparator group (hazard ratio for death, 0.80; 95.05% CI, 0.64 to 1.00; P = 0.046).","['patients with  EGFR  mutation-positive advanced non-small-cell lung cancer (NSCLC', 'patients with previously untreated advanced NSCLC with an  EGFR  mutation', '556 patients with previously untreated advanced NSCLC with an  EGFR  mutation (exon 19 deletion or L858R allele) in a 1:1 ratio to receive either']","['osimertinib (80 mg once daily) or one of two other EGFR-TKIs (gefitinib at a dose of 250 mg once daily or erlotinib', 'first-line osimertinib with other EGFR-TKIs']","['Adverse events of grade 3 or higher', 'longer progression-free survival', 'overall survival', 'median overall survival', 'Overall Survival', 'Overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C4517811', 'cui_str': 'Five hundred and fifty-six'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C1442161', 'cui_str': 'Deletion (morphologic abnormality)'}, {'cui': 'C0002085', 'cui_str': 'Allelomorphs'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]","[{'cui': 'C4058811', 'cui_str': 'osimertinib'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",556.0,0.534357,"The median overall survival was 38.6 months (95% confidence interval [CI], 34.5 to 41.8) in the osimertinib group and 31.8 months (95% CI, 26.6 to 36.0) in the comparator group (hazard ratio for death, 0.80; 95.05% CI, 0.64 to 1.00; P = 0.046).","[{'ForeName': 'Suresh S', 'Initials': 'SS', 'LastName': 'Ramalingam', 'Affiliation': 'From Winship Cancer Institute, Emory University School of Medicine, Atlanta (S.S.R.); the Respiratory Oncology Unit, Department of Respiratory Medicine, University Hospital KU Leuven, Leuven, Belgium (J.V.); the Thoracic Unit, Department of Medical Oncology, Institut Gustave Roussy, Villejuif (D.P., J.-C.S.), and University Paris Sud, Orsay (J.-C.S.) - both in France; the Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul (B.C.C.), and the Division of Medical Oncology, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju (K.H.L.) - both in South Korea; the Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL (J.E.G.); the Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo (Y.O.), the Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka (F.I.), and the Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka (T.K.) - all in Japan; Pulmonary Hospital of Tongji University, Shanghai (C.Z.), and Jilin Provincial Cancer Hospital, Changchun (Y.C.) - both in China; the Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok (T.R.), and the Oncology Unit, Department of Medicine, Chiang Mai University, Chiang Mai (B.C.) - both in Thailand; Kent Oncology Centre, Maidstone Hospital, and Tunbridge Wells NHS Trust, Maidstone (R.S.), and Late Oncology Statistics (A.T., R.H.) and Oncology Research and Development (M.S., Y.R.), AstraZeneca, Cambridge - both in the United Kingdom; Hospital Regional Universitario Málaga, Instituto de Investigación Biomédica de Málaga, Malaga, Spain (M.C.); William Osler Health System, University of Toronto, Toronto (P.C.); the Department of Medicine and Surgery, University of Parma and Medical Oncology Unit, University Hospital of Parma, Parma, Italy (M.T.); the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan (M.-C.L.); and Early Oncology Research and Development, AstraZeneca, Gaithersburg, MD (J.-C.S.).'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Vansteenkiste', 'Affiliation': 'From Winship Cancer Institute, Emory University School of Medicine, Atlanta (S.S.R.); the Respiratory Oncology Unit, Department of Respiratory Medicine, University Hospital KU Leuven, Leuven, Belgium (J.V.); the Thoracic Unit, Department of Medical Oncology, Institut Gustave Roussy, Villejuif (D.P., J.-C.S.), and University Paris Sud, Orsay (J.-C.S.) - both in France; the Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul (B.C.C.), and the Division of Medical Oncology, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju (K.H.L.) - both in South Korea; the Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL (J.E.G.); the Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo (Y.O.), the Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka (F.I.), and the Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka (T.K.) - all in Japan; Pulmonary Hospital of Tongji University, Shanghai (C.Z.), and Jilin Provincial Cancer Hospital, Changchun (Y.C.) - both in China; the Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok (T.R.), and the Oncology Unit, Department of Medicine, Chiang Mai University, Chiang Mai (B.C.) - both in Thailand; Kent Oncology Centre, Maidstone Hospital, and Tunbridge Wells NHS Trust, Maidstone (R.S.), and Late Oncology Statistics (A.T., R.H.) and Oncology Research and Development (M.S., Y.R.), AstraZeneca, Cambridge - both in the United Kingdom; Hospital Regional Universitario Málaga, Instituto de Investigación Biomédica de Málaga, Malaga, Spain (M.C.); William Osler Health System, University of Toronto, Toronto (P.C.); the Department of Medicine and Surgery, University of Parma and Medical Oncology Unit, University Hospital of Parma, Parma, Italy (M.T.); the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan (M.-C.L.); and Early Oncology Research and Development, AstraZeneca, Gaithersburg, MD (J.-C.S.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Planchard', 'Affiliation': 'From Winship Cancer Institute, Emory University School of Medicine, Atlanta (S.S.R.); the Respiratory Oncology Unit, Department of Respiratory Medicine, University Hospital KU Leuven, Leuven, Belgium (J.V.); the Thoracic Unit, Department of Medical Oncology, Institut Gustave Roussy, Villejuif (D.P., J.-C.S.), and University Paris Sud, Orsay (J.-C.S.) - both in France; the Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul (B.C.C.), and the Division of Medical Oncology, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju (K.H.L.) - both in South Korea; the Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL (J.E.G.); the Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo (Y.O.), the Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka (F.I.), and the Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka (T.K.) - all in Japan; Pulmonary Hospital of Tongji University, Shanghai (C.Z.), and Jilin Provincial Cancer Hospital, Changchun (Y.C.) - both in China; the Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok (T.R.), and the Oncology Unit, Department of Medicine, Chiang Mai University, Chiang Mai (B.C.) - both in Thailand; Kent Oncology Centre, Maidstone Hospital, and Tunbridge Wells NHS Trust, Maidstone (R.S.), and Late Oncology Statistics (A.T., R.H.) and Oncology Research and Development (M.S., Y.R.), AstraZeneca, Cambridge - both in the United Kingdom; Hospital Regional Universitario Málaga, Instituto de Investigación Biomédica de Málaga, Malaga, Spain (M.C.); William Osler Health System, University of Toronto, Toronto (P.C.); the Department of Medicine and Surgery, University of Parma and Medical Oncology Unit, University Hospital of Parma, Parma, Italy (M.T.); the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan (M.-C.L.); and Early Oncology Research and Development, AstraZeneca, Gaithersburg, MD (J.-C.S.).'}, {'ForeName': 'Byoung Chul', 'Initials': 'BC', 'LastName': 'Cho', 'Affiliation': 'From Winship Cancer Institute, Emory University School of Medicine, Atlanta (S.S.R.); the Respiratory Oncology Unit, Department of Respiratory Medicine, University Hospital KU Leuven, Leuven, Belgium (J.V.); the Thoracic Unit, Department of Medical Oncology, Institut Gustave Roussy, Villejuif (D.P., J.-C.S.), and University Paris Sud, Orsay (J.-C.S.) - both in France; the Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul (B.C.C.), and the Division of Medical Oncology, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju (K.H.L.) - both in South Korea; the Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL (J.E.G.); the Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo (Y.O.), the Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka (F.I.), and the Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka (T.K.) - all in Japan; Pulmonary Hospital of Tongji University, Shanghai (C.Z.), and Jilin Provincial Cancer Hospital, Changchun (Y.C.) - both in China; the Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok (T.R.), and the Oncology Unit, Department of Medicine, Chiang Mai University, Chiang Mai (B.C.) - both in Thailand; Kent Oncology Centre, Maidstone Hospital, and Tunbridge Wells NHS Trust, Maidstone (R.S.), and Late Oncology Statistics (A.T., R.H.) and Oncology Research and Development (M.S., Y.R.), AstraZeneca, Cambridge - both in the United Kingdom; Hospital Regional Universitario Málaga, Instituto de Investigación Biomédica de Málaga, Malaga, Spain (M.C.); William Osler Health System, University of Toronto, Toronto (P.C.); the Department of Medicine and Surgery, University of Parma and Medical Oncology Unit, University Hospital of Parma, Parma, Italy (M.T.); the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan (M.-C.L.); and Early Oncology Research and Development, AstraZeneca, Gaithersburg, MD (J.-C.S.).'}, {'ForeName': 'Jhanelle E', 'Initials': 'JE', 'LastName': 'Gray', 'Affiliation': 'From Winship Cancer Institute, Emory University School of Medicine, Atlanta (S.S.R.); the Respiratory Oncology Unit, Department of Respiratory Medicine, University Hospital KU Leuven, Leuven, Belgium (J.V.); the Thoracic Unit, Department of Medical Oncology, Institut Gustave Roussy, Villejuif (D.P., J.-C.S.), and University Paris Sud, Orsay (J.-C.S.) - both in France; the Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul (B.C.C.), and the Division of Medical Oncology, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju (K.H.L.) - both in South Korea; the Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL (J.E.G.); the Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo (Y.O.), the Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka (F.I.), and the Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka (T.K.) - all in Japan; Pulmonary Hospital of Tongji University, Shanghai (C.Z.), and Jilin Provincial Cancer Hospital, Changchun (Y.C.) - both in China; the Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok (T.R.), and the Oncology Unit, Department of Medicine, Chiang Mai University, Chiang Mai (B.C.) - both in Thailand; Kent Oncology Centre, Maidstone Hospital, and Tunbridge Wells NHS Trust, Maidstone (R.S.), and Late Oncology Statistics (A.T., R.H.) and Oncology Research and Development (M.S., Y.R.), AstraZeneca, Cambridge - both in the United Kingdom; Hospital Regional Universitario Málaga, Instituto de Investigación Biomédica de Málaga, Malaga, Spain (M.C.); William Osler Health System, University of Toronto, Toronto (P.C.); the Department of Medicine and Surgery, University of Parma and Medical Oncology Unit, University Hospital of Parma, Parma, Italy (M.T.); the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan (M.-C.L.); and Early Oncology Research and Development, AstraZeneca, Gaithersburg, MD (J.-C.S.).'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Ohe', 'Affiliation': 'From Winship Cancer Institute, Emory University School of Medicine, Atlanta (S.S.R.); the Respiratory Oncology Unit, Department of Respiratory Medicine, University Hospital KU Leuven, Leuven, Belgium (J.V.); the Thoracic Unit, Department of Medical Oncology, Institut Gustave Roussy, Villejuif (D.P., J.-C.S.), and University Paris Sud, Orsay (J.-C.S.) - both in France; the Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul (B.C.C.), and the Division of Medical Oncology, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju (K.H.L.) - both in South Korea; the Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL (J.E.G.); the Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo (Y.O.), the Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka (F.I.), and the Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka (T.K.) - all in Japan; Pulmonary Hospital of Tongji University, Shanghai (C.Z.), and Jilin Provincial Cancer Hospital, Changchun (Y.C.) - both in China; the Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok (T.R.), and the Oncology Unit, Department of Medicine, Chiang Mai University, Chiang Mai (B.C.) - both in Thailand; Kent Oncology Centre, Maidstone Hospital, and Tunbridge Wells NHS Trust, Maidstone (R.S.), and Late Oncology Statistics (A.T., R.H.) and Oncology Research and Development (M.S., Y.R.), AstraZeneca, Cambridge - both in the United Kingdom; Hospital Regional Universitario Málaga, Instituto de Investigación Biomédica de Málaga, Malaga, Spain (M.C.); William Osler Health System, University of Toronto, Toronto (P.C.); the Department of Medicine and Surgery, University of Parma and Medical Oncology Unit, University Hospital of Parma, Parma, Italy (M.T.); the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan (M.-C.L.); and Early Oncology Research and Development, AstraZeneca, Gaithersburg, MD (J.-C.S.).'}, {'ForeName': 'Caicun', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'From Winship Cancer Institute, Emory University School of Medicine, Atlanta (S.S.R.); the Respiratory Oncology Unit, Department of Respiratory Medicine, University Hospital KU Leuven, Leuven, Belgium (J.V.); the Thoracic Unit, Department of Medical Oncology, Institut Gustave Roussy, Villejuif (D.P., J.-C.S.), and University Paris Sud, Orsay (J.-C.S.) - both in France; the Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul (B.C.C.), and the Division of Medical Oncology, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju (K.H.L.) - both in South Korea; the Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL (J.E.G.); the Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo (Y.O.), the Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka (F.I.), and the Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka (T.K.) - all in Japan; Pulmonary Hospital of Tongji University, Shanghai (C.Z.), and Jilin Provincial Cancer Hospital, Changchun (Y.C.) - both in China; the Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok (T.R.), and the Oncology Unit, Department of Medicine, Chiang Mai University, Chiang Mai (B.C.) - both in Thailand; Kent Oncology Centre, Maidstone Hospital, and Tunbridge Wells NHS Trust, Maidstone (R.S.), and Late Oncology Statistics (A.T., R.H.) and Oncology Research and Development (M.S., Y.R.), AstraZeneca, Cambridge - both in the United Kingdom; Hospital Regional Universitario Málaga, Instituto de Investigación Biomédica de Málaga, Malaga, Spain (M.C.); William Osler Health System, University of Toronto, Toronto (P.C.); the Department of Medicine and Surgery, University of Parma and Medical Oncology Unit, University Hospital of Parma, Parma, Italy (M.T.); the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan (M.-C.L.); and Early Oncology Research and Development, AstraZeneca, Gaithersburg, MD (J.-C.S.).'}, {'ForeName': 'Thanyanan', 'Initials': 'T', 'LastName': 'Reungwetwattana', 'Affiliation': 'From Winship Cancer Institute, Emory University School of Medicine, Atlanta (S.S.R.); the Respiratory Oncology Unit, Department of Respiratory Medicine, University Hospital KU Leuven, Leuven, Belgium (J.V.); the Thoracic Unit, Department of Medical Oncology, Institut Gustave Roussy, Villejuif (D.P., J.-C.S.), and University Paris Sud, Orsay (J.-C.S.) - both in France; the Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul (B.C.C.), and the Division of Medical Oncology, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju (K.H.L.) - both in South Korea; the Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL (J.E.G.); the Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo (Y.O.), the Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka (F.I.), and the Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka (T.K.) - all in Japan; Pulmonary Hospital of Tongji University, Shanghai (C.Z.), and Jilin Provincial Cancer Hospital, Changchun (Y.C.) - both in China; the Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok (T.R.), and the Oncology Unit, Department of Medicine, Chiang Mai University, Chiang Mai (B.C.) - both in Thailand; Kent Oncology Centre, Maidstone Hospital, and Tunbridge Wells NHS Trust, Maidstone (R.S.), and Late Oncology Statistics (A.T., R.H.) and Oncology Research and Development (M.S., Y.R.), AstraZeneca, Cambridge - both in the United Kingdom; Hospital Regional Universitario Málaga, Instituto de Investigación Biomédica de Málaga, Malaga, Spain (M.C.); William Osler Health System, University of Toronto, Toronto (P.C.); the Department of Medicine and Surgery, University of Parma and Medical Oncology Unit, University Hospital of Parma, Parma, Italy (M.T.); the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan (M.-C.L.); and Early Oncology Research and Development, AstraZeneca, Gaithersburg, MD (J.-C.S.).'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'From Winship Cancer Institute, Emory University School of Medicine, Atlanta (S.S.R.); the Respiratory Oncology Unit, Department of Respiratory Medicine, University Hospital KU Leuven, Leuven, Belgium (J.V.); the Thoracic Unit, Department of Medical Oncology, Institut Gustave Roussy, Villejuif (D.P., J.-C.S.), and University Paris Sud, Orsay (J.-C.S.) - both in France; the Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul (B.C.C.), and the Division of Medical Oncology, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju (K.H.L.) - both in South Korea; the Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL (J.E.G.); the Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo (Y.O.), the Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka (F.I.), and the Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka (T.K.) - all in Japan; Pulmonary Hospital of Tongji University, Shanghai (C.Z.), and Jilin Provincial Cancer Hospital, Changchun (Y.C.) - both in China; the Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok (T.R.), and the Oncology Unit, Department of Medicine, Chiang Mai University, Chiang Mai (B.C.) - both in Thailand; Kent Oncology Centre, Maidstone Hospital, and Tunbridge Wells NHS Trust, Maidstone (R.S.), and Late Oncology Statistics (A.T., R.H.) and Oncology Research and Development (M.S., Y.R.), AstraZeneca, Cambridge - both in the United Kingdom; Hospital Regional Universitario Málaga, Instituto de Investigación Biomédica de Málaga, Malaga, Spain (M.C.); William Osler Health System, University of Toronto, Toronto (P.C.); the Department of Medicine and Surgery, University of Parma and Medical Oncology Unit, University Hospital of Parma, Parma, Italy (M.T.); the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan (M.-C.L.); and Early Oncology Research and Development, AstraZeneca, Gaithersburg, MD (J.-C.S.).'}, {'ForeName': 'Busyamas', 'Initials': 'B', 'LastName': 'Chewaskulyong', 'Affiliation': 'From Winship Cancer Institute, Emory University School of Medicine, Atlanta (S.S.R.); the Respiratory Oncology Unit, Department of Respiratory Medicine, University Hospital KU Leuven, Leuven, Belgium (J.V.); the Thoracic Unit, Department of Medical Oncology, Institut Gustave Roussy, Villejuif (D.P., J.-C.S.), and University Paris Sud, Orsay (J.-C.S.) - both in France; the Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul (B.C.C.), and the Division of Medical Oncology, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju (K.H.L.) - both in South Korea; the Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL (J.E.G.); the Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo (Y.O.), the Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka (F.I.), and the Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka (T.K.) - all in Japan; Pulmonary Hospital of Tongji University, Shanghai (C.Z.), and Jilin Provincial Cancer Hospital, Changchun (Y.C.) - both in China; the Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok (T.R.), and the Oncology Unit, Department of Medicine, Chiang Mai University, Chiang Mai (B.C.) - both in Thailand; Kent Oncology Centre, Maidstone Hospital, and Tunbridge Wells NHS Trust, Maidstone (R.S.), and Late Oncology Statistics (A.T., R.H.) and Oncology Research and Development (M.S., Y.R.), AstraZeneca, Cambridge - both in the United Kingdom; Hospital Regional Universitario Málaga, Instituto de Investigación Biomédica de Málaga, Malaga, Spain (M.C.); William Osler Health System, University of Toronto, Toronto (P.C.); the Department of Medicine and Surgery, University of Parma and Medical Oncology Unit, University Hospital of Parma, Parma, Italy (M.T.); the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan (M.-C.L.); and Early Oncology Research and Development, AstraZeneca, Gaithersburg, MD (J.-C.S.).'}, {'ForeName': 'Riyaz', 'Initials': 'R', 'LastName': 'Shah', 'Affiliation': 'From Winship Cancer Institute, Emory University School of Medicine, Atlanta (S.S.R.); the Respiratory Oncology Unit, Department of Respiratory Medicine, University Hospital KU Leuven, Leuven, Belgium (J.V.); the Thoracic Unit, Department of Medical Oncology, Institut Gustave Roussy, Villejuif (D.P., J.-C.S.), and University Paris Sud, Orsay (J.-C.S.) - both in France; the Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul (B.C.C.), and the Division of Medical Oncology, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju (K.H.L.) - both in South Korea; the Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL (J.E.G.); the Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo (Y.O.), the Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka (F.I.), and the Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka (T.K.) - all in Japan; Pulmonary Hospital of Tongji University, Shanghai (C.Z.), and Jilin Provincial Cancer Hospital, Changchun (Y.C.) - both in China; the Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok (T.R.), and the Oncology Unit, Department of Medicine, Chiang Mai University, Chiang Mai (B.C.) - both in Thailand; Kent Oncology Centre, Maidstone Hospital, and Tunbridge Wells NHS Trust, Maidstone (R.S.), and Late Oncology Statistics (A.T., R.H.) and Oncology Research and Development (M.S., Y.R.), AstraZeneca, Cambridge - both in the United Kingdom; Hospital Regional Universitario Málaga, Instituto de Investigación Biomédica de Málaga, Malaga, Spain (M.C.); William Osler Health System, University of Toronto, Toronto (P.C.); the Department of Medicine and Surgery, University of Parma and Medical Oncology Unit, University Hospital of Parma, Parma, Italy (M.T.); the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan (M.-C.L.); and Early Oncology Research and Development, AstraZeneca, Gaithersburg, MD (J.-C.S.).'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Cobo', 'Affiliation': 'From Winship Cancer Institute, Emory University School of Medicine, Atlanta (S.S.R.); the Respiratory Oncology Unit, Department of Respiratory Medicine, University Hospital KU Leuven, Leuven, Belgium (J.V.); the Thoracic Unit, Department of Medical Oncology, Institut Gustave Roussy, Villejuif (D.P., J.-C.S.), and University Paris Sud, Orsay (J.-C.S.) - both in France; the Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul (B.C.C.), and the Division of Medical Oncology, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju (K.H.L.) - both in South Korea; the Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL (J.E.G.); the Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo (Y.O.), the Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka (F.I.), and the Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka (T.K.) - all in Japan; Pulmonary Hospital of Tongji University, Shanghai (C.Z.), and Jilin Provincial Cancer Hospital, Changchun (Y.C.) - both in China; the Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok (T.R.), and the Oncology Unit, Department of Medicine, Chiang Mai University, Chiang Mai (B.C.) - both in Thailand; Kent Oncology Centre, Maidstone Hospital, and Tunbridge Wells NHS Trust, Maidstone (R.S.), and Late Oncology Statistics (A.T., R.H.) and Oncology Research and Development (M.S., Y.R.), AstraZeneca, Cambridge - both in the United Kingdom; Hospital Regional Universitario Málaga, Instituto de Investigación Biomédica de Málaga, Malaga, Spain (M.C.); William Osler Health System, University of Toronto, Toronto (P.C.); the Department of Medicine and Surgery, University of Parma and Medical Oncology Unit, University Hospital of Parma, Parma, Italy (M.T.); the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan (M.-C.L.); and Early Oncology Research and Development, AstraZeneca, Gaithersburg, MD (J.-C.S.).'}, {'ForeName': 'Ki Hyeong', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'From Winship Cancer Institute, Emory University School of Medicine, Atlanta (S.S.R.); the Respiratory Oncology Unit, Department of Respiratory Medicine, University Hospital KU Leuven, Leuven, Belgium (J.V.); the Thoracic Unit, Department of Medical Oncology, Institut Gustave Roussy, Villejuif (D.P., J.-C.S.), and University Paris Sud, Orsay (J.-C.S.) - both in France; the Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul (B.C.C.), and the Division of Medical Oncology, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju (K.H.L.) - both in South Korea; the Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL (J.E.G.); the Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo (Y.O.), the Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka (F.I.), and the Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka (T.K.) - all in Japan; Pulmonary Hospital of Tongji University, Shanghai (C.Z.), and Jilin Provincial Cancer Hospital, Changchun (Y.C.) - both in China; the Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok (T.R.), and the Oncology Unit, Department of Medicine, Chiang Mai University, Chiang Mai (B.C.) - both in Thailand; Kent Oncology Centre, Maidstone Hospital, and Tunbridge Wells NHS Trust, Maidstone (R.S.), and Late Oncology Statistics (A.T., R.H.) and Oncology Research and Development (M.S., Y.R.), AstraZeneca, Cambridge - both in the United Kingdom; Hospital Regional Universitario Málaga, Instituto de Investigación Biomédica de Málaga, Malaga, Spain (M.C.); William Osler Health System, University of Toronto, Toronto (P.C.); the Department of Medicine and Surgery, University of Parma and Medical Oncology Unit, University Hospital of Parma, Parma, Italy (M.T.); the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan (M.-C.L.); and Early Oncology Research and Development, AstraZeneca, Gaithersburg, MD (J.-C.S.).'}, {'ForeName': 'Parneet', 'Initials': 'P', 'LastName': 'Cheema', 'Affiliation': 'From Winship Cancer Institute, Emory University School of Medicine, Atlanta (S.S.R.); the Respiratory Oncology Unit, Department of Respiratory Medicine, University Hospital KU Leuven, Leuven, Belgium (J.V.); the Thoracic Unit, Department of Medical Oncology, Institut Gustave Roussy, Villejuif (D.P., J.-C.S.), and University Paris Sud, Orsay (J.-C.S.) - both in France; the Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul (B.C.C.), and the Division of Medical Oncology, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju (K.H.L.) - both in South Korea; the Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL (J.E.G.); the Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo (Y.O.), the Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka (F.I.), and the Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka (T.K.) - all in Japan; Pulmonary Hospital of Tongji University, Shanghai (C.Z.), and Jilin Provincial Cancer Hospital, Changchun (Y.C.) - both in China; the Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok (T.R.), and the Oncology Unit, Department of Medicine, Chiang Mai University, Chiang Mai (B.C.) - both in Thailand; Kent Oncology Centre, Maidstone Hospital, and Tunbridge Wells NHS Trust, Maidstone (R.S.), and Late Oncology Statistics (A.T., R.H.) and Oncology Research and Development (M.S., Y.R.), AstraZeneca, Cambridge - both in the United Kingdom; Hospital Regional Universitario Málaga, Instituto de Investigación Biomédica de Málaga, Malaga, Spain (M.C.); William Osler Health System, University of Toronto, Toronto (P.C.); the Department of Medicine and Surgery, University of Parma and Medical Oncology Unit, University Hospital of Parma, Parma, Italy (M.T.); the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan (M.-C.L.); and Early Oncology Research and Development, AstraZeneca, Gaithersburg, MD (J.-C.S.).'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Tiseo', 'Affiliation': 'From Winship Cancer Institute, Emory University School of Medicine, Atlanta (S.S.R.); the Respiratory Oncology Unit, Department of Respiratory Medicine, University Hospital KU Leuven, Leuven, Belgium (J.V.); the Thoracic Unit, Department of Medical Oncology, Institut Gustave Roussy, Villejuif (D.P., J.-C.S.), and University Paris Sud, Orsay (J.-C.S.) - both in France; the Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul (B.C.C.), and the Division of Medical Oncology, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju (K.H.L.) - both in South Korea; the Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL (J.E.G.); the Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo (Y.O.), the Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka (F.I.), and the Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka (T.K.) - all in Japan; Pulmonary Hospital of Tongji University, Shanghai (C.Z.), and Jilin Provincial Cancer Hospital, Changchun (Y.C.) - both in China; the Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok (T.R.), and the Oncology Unit, Department of Medicine, Chiang Mai University, Chiang Mai (B.C.) - both in Thailand; Kent Oncology Centre, Maidstone Hospital, and Tunbridge Wells NHS Trust, Maidstone (R.S.), and Late Oncology Statistics (A.T., R.H.) and Oncology Research and Development (M.S., Y.R.), AstraZeneca, Cambridge - both in the United Kingdom; Hospital Regional Universitario Málaga, Instituto de Investigación Biomédica de Málaga, Malaga, Spain (M.C.); William Osler Health System, University of Toronto, Toronto (P.C.); the Department of Medicine and Surgery, University of Parma and Medical Oncology Unit, University Hospital of Parma, Parma, Italy (M.T.); the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan (M.-C.L.); and Early Oncology Research and Development, AstraZeneca, Gaithersburg, MD (J.-C.S.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'John', 'Affiliation': 'From Winship Cancer Institute, Emory University School of Medicine, Atlanta (S.S.R.); the Respiratory Oncology Unit, Department of Respiratory Medicine, University Hospital KU Leuven, Leuven, Belgium (J.V.); the Thoracic Unit, Department of Medical Oncology, Institut Gustave Roussy, Villejuif (D.P., J.-C.S.), and University Paris Sud, Orsay (J.-C.S.) - both in France; the Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul (B.C.C.), and the Division of Medical Oncology, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju (K.H.L.) - both in South Korea; the Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL (J.E.G.); the Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo (Y.O.), the Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka (F.I.), and the Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka (T.K.) - all in Japan; Pulmonary Hospital of Tongji University, Shanghai (C.Z.), and Jilin Provincial Cancer Hospital, Changchun (Y.C.) - both in China; the Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok (T.R.), and the Oncology Unit, Department of Medicine, Chiang Mai University, Chiang Mai (B.C.) - both in Thailand; Kent Oncology Centre, Maidstone Hospital, and Tunbridge Wells NHS Trust, Maidstone (R.S.), and Late Oncology Statistics (A.T., R.H.) and Oncology Research and Development (M.S., Y.R.), AstraZeneca, Cambridge - both in the United Kingdom; Hospital Regional Universitario Málaga, Instituto de Investigación Biomédica de Málaga, Malaga, Spain (M.C.); William Osler Health System, University of Toronto, Toronto (P.C.); the Department of Medicine and Surgery, University of Parma and Medical Oncology Unit, University Hospital of Parma, Parma, Italy (M.T.); the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan (M.-C.L.); and Early Oncology Research and Development, AstraZeneca, Gaithersburg, MD (J.-C.S.).'}, {'ForeName': 'Meng-Chih', 'Initials': 'MC', 'LastName': 'Lin', 'Affiliation': 'From Winship Cancer Institute, Emory University School of Medicine, Atlanta (S.S.R.); the Respiratory Oncology Unit, Department of Respiratory Medicine, University Hospital KU Leuven, Leuven, Belgium (J.V.); the Thoracic Unit, Department of Medical Oncology, Institut Gustave Roussy, Villejuif (D.P., J.-C.S.), and University Paris Sud, Orsay (J.-C.S.) - both in France; the Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul (B.C.C.), and the Division of Medical Oncology, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju (K.H.L.) - both in South Korea; the Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL (J.E.G.); the Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo (Y.O.), the Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka (F.I.), and the Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka (T.K.) - all in Japan; Pulmonary Hospital of Tongji University, Shanghai (C.Z.), and Jilin Provincial Cancer Hospital, Changchun (Y.C.) - both in China; the Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok (T.R.), and the Oncology Unit, Department of Medicine, Chiang Mai University, Chiang Mai (B.C.) - both in Thailand; Kent Oncology Centre, Maidstone Hospital, and Tunbridge Wells NHS Trust, Maidstone (R.S.), and Late Oncology Statistics (A.T., R.H.) and Oncology Research and Development (M.S., Y.R.), AstraZeneca, Cambridge - both in the United Kingdom; Hospital Regional Universitario Málaga, Instituto de Investigación Biomédica de Málaga, Malaga, Spain (M.C.); William Osler Health System, University of Toronto, Toronto (P.C.); the Department of Medicine and Surgery, University of Parma and Medical Oncology Unit, University Hospital of Parma, Parma, Italy (M.T.); the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan (M.-C.L.); and Early Oncology Research and Development, AstraZeneca, Gaithersburg, MD (J.-C.S.).'}, {'ForeName': 'Fumio', 'Initials': 'F', 'LastName': 'Imamura', 'Affiliation': 'From Winship Cancer Institute, Emory University School of Medicine, Atlanta (S.S.R.); the Respiratory Oncology Unit, Department of Respiratory Medicine, University Hospital KU Leuven, Leuven, Belgium (J.V.); the Thoracic Unit, Department of Medical Oncology, Institut Gustave Roussy, Villejuif (D.P., J.-C.S.), and University Paris Sud, Orsay (J.-C.S.) - both in France; the Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul (B.C.C.), and the Division of Medical Oncology, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju (K.H.L.) - both in South Korea; the Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL (J.E.G.); the Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo (Y.O.), the Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka (F.I.), and the Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka (T.K.) - all in Japan; Pulmonary Hospital of Tongji University, Shanghai (C.Z.), and Jilin Provincial Cancer Hospital, Changchun (Y.C.) - both in China; the Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok (T.R.), and the Oncology Unit, Department of Medicine, Chiang Mai University, Chiang Mai (B.C.) - both in Thailand; Kent Oncology Centre, Maidstone Hospital, and Tunbridge Wells NHS Trust, Maidstone (R.S.), and Late Oncology Statistics (A.T., R.H.) and Oncology Research and Development (M.S., Y.R.), AstraZeneca, Cambridge - both in the United Kingdom; Hospital Regional Universitario Málaga, Instituto de Investigación Biomédica de Málaga, Malaga, Spain (M.C.); William Osler Health System, University of Toronto, Toronto (P.C.); the Department of Medicine and Surgery, University of Parma and Medical Oncology Unit, University Hospital of Parma, Parma, Italy (M.T.); the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan (M.-C.L.); and Early Oncology Research and Development, AstraZeneca, Gaithersburg, MD (J.-C.S.).'}, {'ForeName': 'Takayasu', 'Initials': 'T', 'LastName': 'Kurata', 'Affiliation': 'From Winship Cancer Institute, Emory University School of Medicine, Atlanta (S.S.R.); the Respiratory Oncology Unit, Department of Respiratory Medicine, University Hospital KU Leuven, Leuven, Belgium (J.V.); the Thoracic Unit, Department of Medical Oncology, Institut Gustave Roussy, Villejuif (D.P., J.-C.S.), and University Paris Sud, Orsay (J.-C.S.) - both in France; the Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul (B.C.C.), and the Division of Medical Oncology, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju (K.H.L.) - both in South Korea; the Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL (J.E.G.); the Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo (Y.O.), the Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka (F.I.), and the Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka (T.K.) - all in Japan; Pulmonary Hospital of Tongji University, Shanghai (C.Z.), and Jilin Provincial Cancer Hospital, Changchun (Y.C.) - both in China; the Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok (T.R.), and the Oncology Unit, Department of Medicine, Chiang Mai University, Chiang Mai (B.C.) - both in Thailand; Kent Oncology Centre, Maidstone Hospital, and Tunbridge Wells NHS Trust, Maidstone (R.S.), and Late Oncology Statistics (A.T., R.H.) and Oncology Research and Development (M.S., Y.R.), AstraZeneca, Cambridge - both in the United Kingdom; Hospital Regional Universitario Málaga, Instituto de Investigación Biomédica de Málaga, Malaga, Spain (M.C.); William Osler Health System, University of Toronto, Toronto (P.C.); the Department of Medicine and Surgery, University of Parma and Medical Oncology Unit, University Hospital of Parma, Parma, Italy (M.T.); the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan (M.-C.L.); and Early Oncology Research and Development, AstraZeneca, Gaithersburg, MD (J.-C.S.).'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Todd', 'Affiliation': 'From Winship Cancer Institute, Emory University School of Medicine, Atlanta (S.S.R.); the Respiratory Oncology Unit, Department of Respiratory Medicine, University Hospital KU Leuven, Leuven, Belgium (J.V.); the Thoracic Unit, Department of Medical Oncology, Institut Gustave Roussy, Villejuif (D.P., J.-C.S.), and University Paris Sud, Orsay (J.-C.S.) - both in France; the Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul (B.C.C.), and the Division of Medical Oncology, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju (K.H.L.) - both in South Korea; the Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL (J.E.G.); the Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo (Y.O.), the Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka (F.I.), and the Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka (T.K.) - all in Japan; Pulmonary Hospital of Tongji University, Shanghai (C.Z.), and Jilin Provincial Cancer Hospital, Changchun (Y.C.) - both in China; the Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok (T.R.), and the Oncology Unit, Department of Medicine, Chiang Mai University, Chiang Mai (B.C.) - both in Thailand; Kent Oncology Centre, Maidstone Hospital, and Tunbridge Wells NHS Trust, Maidstone (R.S.), and Late Oncology Statistics (A.T., R.H.) and Oncology Research and Development (M.S., Y.R.), AstraZeneca, Cambridge - both in the United Kingdom; Hospital Regional Universitario Málaga, Instituto de Investigación Biomédica de Málaga, Malaga, Spain (M.C.); William Osler Health System, University of Toronto, Toronto (P.C.); the Department of Medicine and Surgery, University of Parma and Medical Oncology Unit, University Hospital of Parma, Parma, Italy (M.T.); the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan (M.-C.L.); and Early Oncology Research and Development, AstraZeneca, Gaithersburg, MD (J.-C.S.).'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Hodge', 'Affiliation': 'From Winship Cancer Institute, Emory University School of Medicine, Atlanta (S.S.R.); the Respiratory Oncology Unit, Department of Respiratory Medicine, University Hospital KU Leuven, Leuven, Belgium (J.V.); the Thoracic Unit, Department of Medical Oncology, Institut Gustave Roussy, Villejuif (D.P., J.-C.S.), and University Paris Sud, Orsay (J.-C.S.) - both in France; the Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul (B.C.C.), and the Division of Medical Oncology, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju (K.H.L.) - both in South Korea; the Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL (J.E.G.); the Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo (Y.O.), the Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka (F.I.), and the Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka (T.K.) - all in Japan; Pulmonary Hospital of Tongji University, Shanghai (C.Z.), and Jilin Provincial Cancer Hospital, Changchun (Y.C.) - both in China; the Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok (T.R.), and the Oncology Unit, Department of Medicine, Chiang Mai University, Chiang Mai (B.C.) - both in Thailand; Kent Oncology Centre, Maidstone Hospital, and Tunbridge Wells NHS Trust, Maidstone (R.S.), and Late Oncology Statistics (A.T., R.H.) and Oncology Research and Development (M.S., Y.R.), AstraZeneca, Cambridge - both in the United Kingdom; Hospital Regional Universitario Málaga, Instituto de Investigación Biomédica de Málaga, Malaga, Spain (M.C.); William Osler Health System, University of Toronto, Toronto (P.C.); the Department of Medicine and Surgery, University of Parma and Medical Oncology Unit, University Hospital of Parma, Parma, Italy (M.T.); the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan (M.-C.L.); and Early Oncology Research and Development, AstraZeneca, Gaithersburg, MD (J.-C.S.).'}, {'ForeName': 'Matilde', 'Initials': 'M', 'LastName': 'Saggese', 'Affiliation': 'From Winship Cancer Institute, Emory University School of Medicine, Atlanta (S.S.R.); the Respiratory Oncology Unit, Department of Respiratory Medicine, University Hospital KU Leuven, Leuven, Belgium (J.V.); the Thoracic Unit, Department of Medical Oncology, Institut Gustave Roussy, Villejuif (D.P., J.-C.S.), and University Paris Sud, Orsay (J.-C.S.) - both in France; the Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul (B.C.C.), and the Division of Medical Oncology, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju (K.H.L.) - both in South Korea; the Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL (J.E.G.); the Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo (Y.O.), the Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka (F.I.), and the Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka (T.K.) - all in Japan; Pulmonary Hospital of Tongji University, Shanghai (C.Z.), and Jilin Provincial Cancer Hospital, Changchun (Y.C.) - both in China; the Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok (T.R.), and the Oncology Unit, Department of Medicine, Chiang Mai University, Chiang Mai (B.C.) - both in Thailand; Kent Oncology Centre, Maidstone Hospital, and Tunbridge Wells NHS Trust, Maidstone (R.S.), and Late Oncology Statistics (A.T., R.H.) and Oncology Research and Development (M.S., Y.R.), AstraZeneca, Cambridge - both in the United Kingdom; Hospital Regional Universitario Málaga, Instituto de Investigación Biomédica de Málaga, Malaga, Spain (M.C.); William Osler Health System, University of Toronto, Toronto (P.C.); the Department of Medicine and Surgery, University of Parma and Medical Oncology Unit, University Hospital of Parma, Parma, Italy (M.T.); the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan (M.-C.L.); and Early Oncology Research and Development, AstraZeneca, Gaithersburg, MD (J.-C.S.).'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Rukazenkov', 'Affiliation': 'From Winship Cancer Institute, Emory University School of Medicine, Atlanta (S.S.R.); the Respiratory Oncology Unit, Department of Respiratory Medicine, University Hospital KU Leuven, Leuven, Belgium (J.V.); the Thoracic Unit, Department of Medical Oncology, Institut Gustave Roussy, Villejuif (D.P., J.-C.S.), and University Paris Sud, Orsay (J.-C.S.) - both in France; the Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul (B.C.C.), and the Division of Medical Oncology, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju (K.H.L.) - both in South Korea; the Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL (J.E.G.); the Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo (Y.O.), the Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka (F.I.), and the Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka (T.K.) - all in Japan; Pulmonary Hospital of Tongji University, Shanghai (C.Z.), and Jilin Provincial Cancer Hospital, Changchun (Y.C.) - both in China; the Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok (T.R.), and the Oncology Unit, Department of Medicine, Chiang Mai University, Chiang Mai (B.C.) - both in Thailand; Kent Oncology Centre, Maidstone Hospital, and Tunbridge Wells NHS Trust, Maidstone (R.S.), and Late Oncology Statistics (A.T., R.H.) and Oncology Research and Development (M.S., Y.R.), AstraZeneca, Cambridge - both in the United Kingdom; Hospital Regional Universitario Málaga, Instituto de Investigación Biomédica de Málaga, Malaga, Spain (M.C.); William Osler Health System, University of Toronto, Toronto (P.C.); the Department of Medicine and Surgery, University of Parma and Medical Oncology Unit, University Hospital of Parma, Parma, Italy (M.T.); the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan (M.-C.L.); and Early Oncology Research and Development, AstraZeneca, Gaithersburg, MD (J.-C.S.).'}, {'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Soria', 'Affiliation': 'From Winship Cancer Institute, Emory University School of Medicine, Atlanta (S.S.R.); the Respiratory Oncology Unit, Department of Respiratory Medicine, University Hospital KU Leuven, Leuven, Belgium (J.V.); the Thoracic Unit, Department of Medical Oncology, Institut Gustave Roussy, Villejuif (D.P., J.-C.S.), and University Paris Sud, Orsay (J.-C.S.) - both in France; the Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul (B.C.C.), and the Division of Medical Oncology, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju (K.H.L.) - both in South Korea; the Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL (J.E.G.); the Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo (Y.O.), the Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka (F.I.), and the Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka (T.K.) - all in Japan; Pulmonary Hospital of Tongji University, Shanghai (C.Z.), and Jilin Provincial Cancer Hospital, Changchun (Y.C.) - both in China; the Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok (T.R.), and the Oncology Unit, Department of Medicine, Chiang Mai University, Chiang Mai (B.C.) - both in Thailand; Kent Oncology Centre, Maidstone Hospital, and Tunbridge Wells NHS Trust, Maidstone (R.S.), and Late Oncology Statistics (A.T., R.H.) and Oncology Research and Development (M.S., Y.R.), AstraZeneca, Cambridge - both in the United Kingdom; Hospital Regional Universitario Málaga, Instituto de Investigación Biomédica de Málaga, Malaga, Spain (M.C.); William Osler Health System, University of Toronto, Toronto (P.C.); the Department of Medicine and Surgery, University of Parma and Medical Oncology Unit, University Hospital of Parma, Parma, Italy (M.T.); the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan (M.-C.L.); and Early Oncology Research and Development, AstraZeneca, Gaithersburg, MD (J.-C.S.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1913662']
408,31567160,Switching from efavirenz to rilpivirine improves sleep quality and self-perceived cognition but has no impact on neurocognitive performances.,"BACKGROUND


Efavirenz (EFV) association with neurocognitive impairment is debated. Whether switching away from EFV improves neurocognitive performances is still controversial.
METHODS


In a randomized open-label controlled trial, patients under effective treatment with tenofovir disoproxil-fumarate (TDF), emtricitabine (FTC) and EFV, who had altered neurocognitive assessment (z-transformed score below -1 in at least one cognitive domain), depression, anxiety or low sleep-quality, were randomized 1 : 1 to immediate or delayed (24-weeks) switch to TDF/FTC/rilpivirine (RPV). Treatment efficacy, neurocognitive function, symptoms and quality of life were evaluated 12, 24 and 48 weeks after randomization.
FINDINGS


Seventy-four patients were randomized to immediate (36 patients) or delayed switch (38 patients). At baseline, 63 and 25% of patients had z-scores below -1 in at least one or two neurocognitive domains, 31.1, 17.6 and 44.6% had significant depression or anxiety symptoms or low sleep quality. At week 24 (primary end-point), overall neurocognitive improvement was observed, with no statistically significant differences between arms, neither considering the global z score (between arms difference +0.1; P = 0.458), nor domain-specific z scores. Patients switching away from EFV had significant greater improvement of sleep quality index (between-arm difference -1.5; P = 0.011), self-reported cognitive failures (-6.2; P = 0.001) and CNS symptoms score (-5; P = 0.002), but not of anxiety or depression. No protocol defined virological failure, grade at least 3 lab abnormalities or drug-related serious adverse events were reported.
CONCLUSION


Our results do not support the hypothesis that switching to RPV improves cognitive function in patient under stable treatment with EFV. Nonetheless, improvements in neuropsychiatric symptoms, sleep quality and self-perceived cognition were observed.",2020,"At week 24 (primary end-point), overall NC improvement was observed, with no statistically significant differences between arms, neither considering the global z-score (between arms difference +0.1; P=0.458), nor domain-specific z-scores.","[' who had altered NC assessment (Z-transformed score below -1 in ≥1 cognitive domains), depression, anxiety or low sleep-quality', '74 patients were randomized to immediate (36 patients) or delayed switch (38 patients']","['Efavirenz (EFV', 'tenofovir disoproxil-fumarate (TDF), emtricitabine (FTC) and EFV', 'TDF/FTC/rilpivirine (RPV', 'efavirenz to rilpivirine']","['virological failure, grade ≥3 lab abnormalities or drug-related serious adverse events', 'self-reported cognitive failures', 'overall NC improvement', 'anxiety or depression', 'sleep quality and self-perceived cognition', 'CNS symptoms score', 'cognitive function', 'depression or anxiety symptoms or low sleep-quality', 'neuropsychiatric symptoms, sleep quality and self-perceived cognition', 'Treatment efficacy, NC function, symptoms and quality of life', 'sleep quality index', 'neurocognitive performances', 'NC performances', 'global z-score']","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}]","[{'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C1566826', 'cui_str': 'Rilpivirine'}]","[{'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0422879', 'cui_str': 'CNS symptom'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4285807', 'cui_str': 'Neuropsychiatric symptoms'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]",74.0,0.140276,"At week 24 (primary end-point), overall NC improvement was observed, with no statistically significant differences between arms, neither considering the global z-score (between arms difference +0.1; P=0.458), nor domain-specific z-scores.","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Lapadula', 'Affiliation': 'SC Malattie Infettive, Ospedale San Gerardo, Monza.'}, {'ForeName': 'Davide Paolo', 'Initials': 'DP', 'LastName': 'Bernasconi', 'Affiliation': 'University of Milano-Bicocca.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Bai', 'Affiliation': 'Ospedale San Paolo, University of Milan, Milan.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Focà', 'Affiliation': 'Clinica di Malattie Infettive e Tropicali, ASST Spedali Civili, University of Brescia, Brescia.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Di Biagio', 'Affiliation': 'Clinica di Malattie Infettive, Ospedale San Martino, Genoa.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Bonora', 'Affiliation': 'Clinica di Malattie Infettive, University of Turin, Turin.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Castelli', 'Affiliation': 'Clinica di Malattie Infettive e Tropicali, ASST Spedali Civili, University of Brescia, Brescia.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Squillace', 'Affiliation': 'SC Malattie Infettive, Ospedale San Gerardo, Monza.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Bandera', 'Affiliation': ""Clinica di Malattie Infettive, IRCCS Fondazione Ca' Granda Policinico di Milano, University of Milan, Milan, Italy.""}, {'ForeName': ""Antonella d'Arminio"", 'Initials': 'AD', 'LastName': 'Monforte', 'Affiliation': 'Ospedale San Paolo, University of Milan, Milan.'}, {'ForeName': 'Guglielmo Marco', 'Initials': 'GM', 'LastName': 'Migliorino', 'Affiliation': 'SC Malattie Infettive, Ospedale San Gerardo, Monza.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Gori', 'Affiliation': ""Clinica di Malattie Infettive, IRCCS Fondazione Ca' Granda Policinico di Milano, University of Milan, Milan, Italy.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","AIDS (London, England)",['10.1097/QAD.0000000000002377']
409,32294732,EFFECTS OF SYNBIOTIC SUPPLEMENTATION ON GUT FUNCTIONING AND SYSTEMIC INFLAMMATION OF COMMUNITY-DWELLING ELDERS - SECONDARY ANALYSES FROM A RANDOMIZED CLINICAL TRIAL.,"BACKGROUND


Aging is a complex process marked by alterations on gut functioning and physiology, accompanied by an increase on the inflammatory status, leading to a scenario called ""inflammaging"".
OBJECTIVE


To evaluate the effects of a synbiotic substance on systemic inflammation, gut functioning of community-dwelling elders.
METHODS


This is a secondary analysis from a randomized clinical trial, lasting 24 weeks, including 49 elders, distributed into two groups: SYN (n=25), which received a synbiotic substance (Frutooligossacaride 6g, Lactobacillus paracasei LPC-31 109 to 108 UFC, Lactobacillus rhamnosus HN001 109 to 108 UFC, Lactobacillus acidophilus NCFM 109 to 108 UFC e Bifidobacterium lactis HN019 109 to 108 UFC), or PLA (n=24), receiving placebo. The evaluations consisted of serum IL-10 e TNF-α (after overnight fasting), evaluation of chronic constipation (by Rome III Criteria) and faeces types (by Bristol Stool Form Scale). Data were compared before and after the supplementation time, and between groups.
RESULTS


No significant differences were found between baseline and final values of serum inflammatory markers. Some subtle beneficial changes were observed in SYN, concerning both gut functioning and faeces types.
CONCLUSION


From our data, synbiotic supplementation showed a subtle benefit in gut functioning in apparently healthy community-dwelling elders. Our findings can suggest that the benefits in healthy individuals were less expressive than the ones presented in studies with individuals previously diagnosed as dysbiosis. Future studies, comparing elders with and without gut dysbiosis can confirm our findings.",2020,No significant differences were found between baseline and final values of serum inflammatory markers.,"['49 elders, distributed into two groups: SYN (n=25', 'HN019 109 to 108 UFC), or PLA (n=24), receiving', 'community-dwelling elders', 'healthy individuals', 'apparently healthy community-dwelling elders']","['serum IL-10 e TNF-α', 'placebo', 'synbiotic substance (Frutooligossacaride 6g, Lactobacillus paracasei LPC-31 109 to 108 UFC, Lactobacillus rhamnosus', 'synbiotic supplementation', 'synbiotic substance']","['gut functioning', 'serum inflammatory markers']","[{'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C1080735', 'cui_str': 'Lactobacillus paracasei'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0317597', 'cui_str': 'Lactobacillus casei rhamnosus'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.0964422,No significant differences were found between baseline and final values of serum inflammatory markers.,"[{'ForeName': 'João', 'Initials': 'J', 'LastName': 'Valentini Neto', 'Affiliation': 'Universidade de São Paulo, Faculdade de Saúde Pública, Departamento de Nutrição, São Paulo, SP, Brasil.'}, {'ForeName': 'Terezinha Perricci', 'Initials': 'TP', 'LastName': 'Chella', 'Affiliation': 'Universidade de São Paulo, Faculdade de Saúde Pública, Departamento de Nutrição, São Paulo, SP, Brasil.'}, {'ForeName': 'Danielle Panipucci', 'Initials': 'DP', 'LastName': 'Rudnik', 'Affiliation': 'Universidade de São Paulo, Faculdade de Saúde Pública, Departamento de Nutrição, São Paulo, SP, Brasil.'}, {'ForeName': 'Sandra Maria Lima', 'Initials': 'SML', 'LastName': 'Ribeiro', 'Affiliation': 'Universidade de São Paulo, Faculdade de Saúde Pública, Departamento de Nutrição, São Paulo, SP, Brasil.'}]",Arquivos de gastroenterologia,['10.1590/S0004-2803.202000000-06']
410,32294559,"Antimicrobial photodynamic therapy with Bixa orellana extract and blue LED in the reduction of halitosis-A randomized, controlled clinical trial.","BACKGROUND


This study aimed to evaluate the reduction of halitosis when using antimicrobial photodynamic therapy (aPDT) with Bixa orellana extract and blue light-emitting diode (LED).
METHODS


Forty-four UNINOVE students or employees with a diagnosis of sulfide (H2S) ≥ 112 ppb in gas chromatography were selected. The patients were randomly divided in groups: Group 1 (n = 15): aPDT with annatto and LED; Group 2 (n = 14): tongue scraping; Group 3 (n = 15): tongue scraping and aPDT. For aPDT, a wasBixa orellana extract used in a concentration of 20 % w/v (Fórmula e Ação®, São Paulo, Brazil) on the tongue for 2 min, associated with a blue-violet LED (Valo Cordless Ultradent® Products, Inc., South Jordan, UT, USA) (395-480 nm). Six points were irradiated on the back of the tongue, at wavelength 395-480 nm for 20 s, energy of 9.6 J and radiant energy of 6.37 J/cm 2  per point. The results were compared before, immediately after treatment and 7 days after. The Friedman test was used for the intragroup analysis and the Kruskal Wallis test for the intergroup analysis.
RESULTS


In all groups, there was a difference between baseline and the value immediately after the treatment. In Groups 1 and 3, there was no difference between the baseline and the 7 days control.
CONCLUSION


There was an immediate reduction of halitosis, but the reduction was not maintained after 7days.",2020,"In Groups 1 and 3, there was no difference between the baseline and the 7 days control.
","['first posted on November 17, 2017, last updated on February 1, 2018', 'Forty-four UNINOVE students or employees with a diagnosis of sulfide (H2S) ≥']","['antimicrobial photodynamic therapy (aPDT) withBixa orellana extract and blue light-emitting diode (LED', 'Antimicrobial photodynamic therapy with Bixa orellana extract and blue LED', 'aPDT with annatto and LED; Group 2 (n\u2009=\u200914): tongue scraping; Group 3 (n\u2009=\u200915): tongue scraping and aPDT']",[],"[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0038739', 'cui_str': 'Sulfide'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0303896', 'cui_str': 'Blue light'}, {'cui': 'C0162676', 'cui_str': 'Enzyme-multiplied immunoassay technique'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C1026070', 'cui_str': 'Bixa'}, {'cui': 'C0051928', 'cui_str': 'Annatto Extract'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0444082', 'cui_str': 'Scrapings'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}]",[],,0.0573173,"In Groups 1 and 3, there was no difference between the baseline and the 7 days control.
","[{'ForeName': 'Marcela Leticia Leal', 'Initials': 'MLL', 'LastName': 'Gonçalves', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University, Vergueiro Street, 235/249 - Liberdade, ZIP 01504-001, São Paulo, SP, Brazil. Electronic address: marcelalleal@hotmail.com.'}, {'ForeName': 'Ana Carolina Costa', 'Initials': 'ACC', 'LastName': 'da Mota', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University, Vergueiro Street, 235/249 - Liberdade, ZIP 01504-001, São Paulo, SP, Brazil. Electronic address: ana_cmota@yahoo.com.br.'}, {'ForeName': 'Alessandro Melo', 'Initials': 'AM', 'LastName': 'Deana', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University, Vergueiro Street, 235/249 - Liberdade, ZIP 01504-001, São Paulo, SP, Brazil. Electronic address: amdeana@gmail.com.'}, {'ForeName': 'Lisyanne Araújo de Souza', 'Initials': 'LAS', 'LastName': 'Cavalcante', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University, Vergueiro Street, 235/249 - Liberdade, ZIP 01504-001, São Paulo, SP, Brazil. Electronic address: lisyanne.araujo@gmail.com.'}, {'ForeName': 'Anna Carolina Ratto Tempestini', 'Initials': 'ACRT', 'LastName': 'Horliana', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University, Vergueiro Street, 235/249 - Liberdade, ZIP 01504-001, São Paulo, SP, Brazil. Electronic address: annacrth@gmail.com.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Pavani', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University, Vergueiro Street, 235/249 - Liberdade, ZIP 01504-001, São Paulo, SP, Brazil. Electronic address: chrispavani@gmail.com.'}, {'ForeName': 'Lara Jansiski', 'Initials': 'LJ', 'LastName': 'Motta', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University, Vergueiro Street, 235/249 - Liberdade, ZIP 01504-001, São Paulo, SP, Brazil. Electronic address: larajmotta@terra.com.br.'}, {'ForeName': 'Kristianne Porta Santos', 'Initials': 'KPS', 'LastName': 'Fernandes', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University, Vergueiro Street, 235/249 - Liberdade, ZIP 01504-001, São Paulo, SP, Brazil. Electronic address: kristianneporta@gmail.com.'}, {'ForeName': 'Raquel Agnelli', 'Initials': 'RA', 'LastName': 'Mesquita-Ferrari', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University, Vergueiro Street, 235/249 - Liberdade, ZIP 01504-001, São Paulo, SP, Brazil. Electronic address: raquel.mesquita@gmail.com.'}, {'ForeName': 'Daniela Fátima Teixeira', 'Initials': 'DFT', 'LastName': 'da Silva', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University, Vergueiro Street, 235/249 - Liberdade, ZIP 01504-001, São Paulo, SP, Brazil. Electronic address: dfteixeira@uni9.pro.br.'}, {'ForeName': 'Pamella de Barros', 'Initials': 'PB', 'LastName': 'Motta', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University, Vergueiro Street, 235/249 - Liberdade, ZIP 01504-001, São Paulo, SP, Brazil. Electronic address: pamellabmotta@gmail.com.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Araújo Prates', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University, Vergueiro Street, 235/249 - Liberdade, ZIP 01504-001, São Paulo, SP, Brazil. Electronic address: pratesra@gmail.com.'}, {'ForeName': 'Sandra Kalil', 'Initials': 'SK', 'LastName': 'Bussadori', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University, Vergueiro Street, 235/249 - Liberdade, ZIP 01504-001, São Paulo, SP, Brazil. Electronic address: sandra.skb@gmail.com.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101751']
411,32294560,"Efficacy of lidocaine 7 %, tetracaine 7 % self-occlusive cream in reducing MAL-cPDT-associated pain in subjects with actinic keratosis: A randomized, single-blind, vehicle-controlled trial (The ""3P-Trial"").","INTRODUCTION


Conventional photodynamic therapy (cPDT) is considered a very effective treatment of actinic keratosis (AK) lesions. However, its use is limited by the fact that this procedure could be very painful. The use of topical anesthetics such as tetracaine or lignocaine/prilocaine has shown disappointing results in term of pain reduction. A self-occlusive topical 7% lidocaine/7% tetracaine anesthetic cream (LT-C) approved by the FDA to provide local topical anesthesia in adults undergoing superficial dermatological procedures is available. There are no data regarding its pain reducing effect during cPDT. We perform a prospective, randomized, single-blind, two-center trial (The 3P-Trial) to assess the pain reduction effect of LT-C versus vehicle in subjects with AK undergoing cPDT.
MATERIAL AND METHODS


Fifty AK subjects (74 ± 10 years, 32 men, 18 women) with on average 17 lesions were enrolled after their written informed consent. Eight subjects presented also a total of 16 basal cell carcinoma lesions. Twenty-five were randomized to LT-cream, applied 1 h before the Methyl amino levulinate (MAL)-cPDT session and 25 to cream vehicle. The main outcome was the patient-assessed evaluation of pain score during and just after the conclusion of cPDT session (mean of the two values) using a 10-point visual analog scale (VAS). The cPDT session (LED Red light 630 nm) was performed with a duration of 6 ± 2 min with a standard fluence of 37 J/cm2. All treated lesions were prepared by gentle superficial curettage.
RESULTS


All the randomized subjects concluded the trial. The mean ± SD of VAS score in vehicle group was 6.2 ± 2.7 (95 % CI of the mean: 5.0-7.5). In the group treated with LT-cream the VAS score was 3.3 ± 1.9 (95 % CI of the mean: 2.5-4.1). The active cream reduced the VAS score by 47 %. Median values of pain VAS score in the active group was reduced by 60 % in comparison with vehicle group (3.0 vs 7.5). The difference between the two groups was statistically significant (p = 0.0009; Mann-Whitney test).
DISCUSSION


The 3P-trial has demonstrated that the preventive application of the self-occlusive lidocaine 7%-tetracaine 7% cream is very effective in reducing the procedure-associated pain during MAL-cPDT for the treatment of AK lesions.",2020,"The difference between the two groups was statistically significant (p = 0.0009; Mann-Whitney test).
","['subjects with actinic keratosis', 'actinic keratosis (AK) lesions', 'Eight subjects presented also a total of 16 basal cell carcinoma lesions', 'Fifty AK subjects (74\u2009±\u200910 years, 32 men, 18 women) with on average 17 lesions were enrolled after their written informed consent', 'Twenty-five were randomized to', 'subjects with AK undergoing cPDT', 'adults undergoing superficial dermatological procedures']","['lidocaine', 'tetracaine or lignocaine/prilocaine', 'lidocaine 7%-tetracaine', 'LT-C versus vehicle', 'LT-cream, applied 1\u2009hour before the Methyl amino levulinate (MAL)-cPDT session and 25 to cream vehicle', 'tetracaine', 'lidocaine/7% tetracaine anesthetic cream (LT-C', 'Conventional photodynamic therapy (cPDT']","['10-point visual analog scale (VAS', 'Median values of pain VAS score', 'VAS score', 'patient-assessed evaluation of pain score', 'pain reduction effect', 'MAL-cPDT-associated pain', 'mean\u2009±\u2009SD of VAS score']","[{'cui': 'C0022602', 'cui_str': 'Actinic keratosis'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007117', 'cui_str': 'Basal cell carcinoma'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0011625', 'cui_str': 'DERMATOLOGICALS'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0039629', 'cui_str': 'Tetracaine'}, {'cui': 'C0033124', 'cui_str': 'Prilocaine'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C3505266', 'cui_str': 'levulinate'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C3505266', 'cui_str': 'levulinate'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",50.0,0.0858632,"The difference between the two groups was statistically significant (p = 0.0009; Mann-Whitney test).
","[{'ForeName': 'Marta Benedetta', 'Initials': 'MB', 'LastName': 'Brumana', 'Affiliation': 'Humanitas San Pio X Clinic, Milan, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Milani', 'Affiliation': 'Cantabria Labs Difa Cooper Medical Direction, Viale Milano 160, Caronno Pertusella, VA, Italy. Electronic address: massimo.milani@difacooper.com.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Puviani', 'Affiliation': 'Dermatology Medica Plus, Modena, Italy.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101758']
412,31942688,Weight Loss and Vomiting 1 Year After Banded Versus Non-banded One Anastomosis Gastric Bypass: a Prospective Randomized Trial.,"BACKGROUND


The weight loss outcomes after banded one-anastomosis gastric bypass (OAGB) remain to be determined.
OBJECTIVE


To compare weight loss and vomiting 1 year after banded versus non-banded OAGB.
METHODS


This is a prospective, open-label, randomized study, which evaluated 33 individuals with morbid obesity, which underwent banded (16 individuals) and non-banded OAGB (17 individuals) and were followed up for 12 months. Weight loss (percentages of total weight loss-%TWL-and excess weight loss-%EWL) and occurrence of vomiting were assessed and compared before surgery and after 6 and 12 months.
RESULTS


At baseline, there were no differences between groups in regard to age, gender, and body mass index (BMI). At 6 and 12 months post-op, and the overall mean %TWL regardless of band use was 22.4 ± 7% and 29 ± 6.9%, respectively, and the overall average %EWL regardless of band use was 66.8 ± 22.9% and 86.3 ± 24%, respectively. %TWL did not differ between the banded and non-banded groups at 6 (21.8 ± 6.8% vs. 23.1 ± 7.4%; p = 0.7) and 12 months post-op (27.5 ± 6.6% vs. 30.4 ± 7.1%; p = 0.3), as well as %EWL at 6 (67 ± 22.9% vs. 67.6 ± 23.6%; p = 0.6) and 12 months post-op (83.5 ± 24.4% vs. 89 ± 24.1%; p = 0.4). The occurrence of vomiting did not significantly differ between banded and non-banded OAGB at 6 (12.5% vs. 11.8%; p = 0.9) and 12 months post-op (12.5% vs. 5.9%; p = 0.5).
CONCLUSION


OAGB led to an overall satisfactory weight loss after 1 year, regardless of band use. Banded OAGB did not lead to neither significantly higher weight loss nor more vomiting than non-banded OAGB 1 year after surgery.",2020,Banded OAGB did not lead to neither significantly higher weight loss nor more vomiting than non-banded OAGB 1 year after surgery.,"['33 individuals with morbid obesity, which underwent banded (16 individuals) and non-banded OAGB (17 individuals) and were followed up for 12\xa0months']","['OAGB', 'Banded Versus Non-banded One Anastomosis Gastric Bypass']","['weight loss and vomiting 1\xa0year', 'overall satisfactory weight loss', 'weight loss nor more vomiting', 'Weight Loss and Vomiting 1 Year', 'occurrence of vomiting', 'Weight loss (percentages of total weight', 'loss-%TWL-and excess weight loss-%EWL) and occurrence of vomiting']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028756', 'cui_str': 'Obesity, Severe'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0042965', 'cui_str': 'Vomitus (substance)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",,0.0252491,Banded OAGB did not lead to neither significantly higher weight loss nor more vomiting than non-banded OAGB 1 year after surgery.,"[{'ForeName': 'Everton', 'Initials': 'E', 'LastName': 'Cazzo', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP), São Paulo, Brazil. notrevezzo@yahoo.com.'}, {'ForeName': 'Laísa Simakawa', 'Initials': 'LS', 'LastName': 'Jimenez', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP), São Paulo, Brazil.'}, {'ForeName': 'Felipe Gilberto', 'Initials': 'FG', 'LastName': 'Valerini', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP), São Paulo, Brazil.'}, {'ForeName': 'Tiago Bezerra', 'Initials': 'TB', 'LastName': 'de Freitas Diniz', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP), São Paulo, Brazil.'}, {'ForeName': 'Almino Cardoso', 'Initials': 'AC', 'LastName': 'Ramos', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP), São Paulo, Brazil.'}, {'ForeName': 'Elinton Adami', 'Initials': 'EA', 'LastName': 'Chaim', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP), São Paulo, Brazil.'}]",Obesity surgery,['10.1007/s11695-020-04393-8']
413,32087337,N-acetylcysteine for the treatment of comorbid alcohol use disorder and posttraumatic stress disorder: Design and methodology of a randomized clinical trial.,"Alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) are two prevalent psychiatric conditions in the U.S. The co-occurrence of AUD and PTSD is also common, and associated with a more severe clinical presentation and worse treatment outcomes across the biopsychosocial spectrum (e.g., social and vocational functioning, physical health) as compared to either disorder alone. Despite the high co-occurrence and negative outcomes, research on effective medications for AUD/PTSD is sparse and there is little empirical evidence to guide treatment decisions. The study described in this paper addresses this knowledge gap by testing the efficacy of N-acetylcysteine (NAC) in reducing alcohol use and PTSD symptoms. Animal studies and prior clinical research suggest a role for NAC in the treatment of substance use disorders and PTSD via glutamate modulation. NAC is a cysteine pro-drug that stimulates the cystine-glutamate exchanger, normalizes glial glutamate transporters, and restores glutamatergic tone on presynaptic receptors in reward regions of the brain. Moreover, NAC is available over-the-counter, has a long-established safety record, and does not require titration to achieve the target dose. This paper describes the rationale, study design, and methodology of a 12-week, randomized, double-blind, placebo-controlled trial of NAC (2400 mg/day) among adults with co-occurring AUD and PTSD. Functional magnetic resonance imaging (fMRI) and proton magnetic resonance spectroscopy ( 1 H-MRS) are utilized to investigate the neural circuitry and neurochemistry underlying comorbid AUD/PTSD and identify predictors of treatment outcome. This study is designed to determine the efficacy of NAC in the treatment of co-occurring AUD/PTSD and provide new information regarding mechanisms of action implicated in co-occurring AUD/PTSD.",2020,Animal studies and prior clinical research suggest a role for NAC in the treatment of substance use disorders and PTSD via glutamate modulation.,"['adults with co-occurring AUD and PTSD', 'comorbid alcohol use disorder and posttraumatic stress disorder']","['placebo', 'NAC', 'N-acetylcysteine', 'Functional magnetic resonance imaging (fMRI) and proton magnetic resonance spectroscopy ( 1 H-MRS', 'N-acetylcysteine (NAC']",['alcohol use and PTSD symptoms'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C3850002', 'cui_str': '1H-MRS'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0324161,Animal studies and prior clinical research suggest a role for NAC in the treatment of substance use disorders and PTSD via glutamate modulation.,"[{'ForeName': 'Sudie E', 'Initials': 'SE', 'LastName': 'Back', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: backs@musc.edu.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Gray', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: graykm@musc.edu.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Santa Ana', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: santaana@musc.edu.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Jones', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: jonjen@musc.edu.'}, {'ForeName': 'Amber M', 'Initials': 'AM', 'LastName': 'Jarnecke', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: jarnecka@musc.edu.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Joseph', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: josep@musc.edu.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Prisciandaro', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: priscian@musc.edu.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Killeen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: killeent@musc.edu.'}, {'ForeName': 'Delisa G', 'Initials': 'DG', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: browdg@musc.edu.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Taimina', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: taimina@musc.edu.'}, {'ForeName': 'Ebele', 'Initials': 'E', 'LastName': 'Compean', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Malcolm', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: malcolmr@musc.edu.'}, {'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: hellmuth@musc.edu.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Kalivas', 'Affiliation': 'Department of Neuroscience, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: kalivasp@musc.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105961']
414,32294530,"Durvalumab with or without tremelimumab in patients with recurrent or metastatic head and neck squamous cell carcinoma: EAGLE, a randomized, open-label phase III study.","BACKGROUND


Targeting the programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) axis has demonstrated clinical benefit in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). Combining immunotherapies targeting PD-L1 and cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) has shown evidence of additive activity in several tumor types. This phase III study evaluated the efficacy of durvalumab (an anti-PD-L1 monoclonal antibody) or durvalumab plus tremelimumab (an anti-CTLA-4 monoclonal antibody) versus standard of care (SoC) in R/M HNSCC patients.
PATIENTS AND METHODS


Patients were randomly assigned to receive 1 : 1 : 1 durvalumab (10 mg/kg every 2 weeks [q2w]), durvalumab plus tremelimumab (durvalumab 20 mg/kg q4w plus tremelimumab 1 mg/kg q4w × 4, then durvalumab 10 mg/kg q2w), or SoC (cetuximab, a taxane, methotrexate, or a fluoropyrimidine). The primary end points were overall survival (OS) for durvalumab versus SoC, and OS for durvalumab plus tremelimumab versus SoC. Secondary end points included progression-free survival (PFS), objective response rate, and duration of response.
RESULTS


Patients were randomly assigned to receive durvalumab (n = 240), durvalumab plus tremelimumab (n = 247), or SoC (n = 249). No statistically significant improvements in OS were observed for durvalumab versus SoC [hazard ratio (HR): 0.88; 95% confidence interval (CI): 0.72-1.08; P = 0.20] or durvalumab plus tremelimumab versus SoC (HR: 1.04; 95% CI: 0.85-1.26; P = 0.76). The 12-month survival rates (95% CI) were 37.0% (30.9-43.1), 30.4% (24.7-36.3), and 30.5% (24.7-36.4) for durvalumab, durvalumab plus tremelimumab, and SoC, respectively. Treatment-related adverse events (trAEs) were consistent with previous reports. The most common trAEs (any grade) were hypothyroidism for durvalumab and durvalumab plus tremelimumab (11.4% and 12.2%, respectively), and anemia (17.5%) for SoC. Grade ≥3 trAE rates were 10.1%, 16.3%, and 24.2% for durvalumab, durvalumab plus tremelimumab, and SoC, respectively.
CONCLUSION


There were no statistically significant differences in OS for durvalumab or durvalumab plus tremelimumab versus SoC. However, higher survival rates at 12 to 24 months and response rates demonstrate clinical activity for durvalumab.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT02369874.",2020,There were no statistically significant differences in OS for durvalumab or durvalumab plus tremelimumab versus SoC.,"['patients with recurrent or metastatic head and neck squamous cell carcinoma', 'Patients', 'R/M HNSCC patients', 'recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC', 'n=247), or SoC (n=249']","['durvalumab', 'SoC', 'durvalumab [10 mg/kg every 2 weeks (Q2W)], durvalumab plus tremelimumab (durvalumab 20 mg/kg Q4W plus tremelimumab 1 mg/kg Q4W × 4, then durvalumab 10 mg/kg Q2W), or SoC (cetuximab, a taxane, methotrexate or a fluoropyrimidine', 'Durvalumab with or without tremelimumab', 'durvalumab plus tremelimumab']","['progression-free survival (PFS), objective response rate, and duration of response', 'hypothyroidism for durvalumab and durvalumab plus tremelimumab', 'anemia', 'higher survival rates', '12-month survival rates', 'OS', 'trAE rates', 'overall survival (OS) for durvalumab versus SoC, and OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0744620', 'cui_str': 'Squamous cell carcinoma of head and neck metastatic'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2351038', 'cui_str': 'tremelimumab'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2351038', 'cui_str': 'tremelimumab'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]",,0.104994,There were no statistically significant differences in OS for durvalumab or durvalumab plus tremelimumab versus SoC.,"[{'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Ferris', 'Affiliation': 'Department of Otolaryngology, UPMC Hillman Cancer Center, Pittsburgh, USA. Electronic address: ferrrl@UPMC.EDU.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Haddad', 'Affiliation': 'Department of Medical Oncology, Dana Farber Cancer Institute, Boston, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Even', 'Affiliation': 'Head and Neck Department, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Tahara', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dvorkin', 'Affiliation': 'Omsk Regional Oncology Dispensary, Omsk, Omskaya, Russian Federation.'}, {'ForeName': 'T E', 'Initials': 'TE', 'LastName': 'Ciuleanu', 'Affiliation': 'Ion Chiricuta Institute of Oncology, Iuliu Haţieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Clement', 'Affiliation': 'Department of Oncology, Leuven Cancer Institute, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mesia', 'Affiliation': ""Catalan Institute of Oncology, IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kutukova', 'Affiliation': 'Chemotherapy Department, SPb SBIH City Clinical Oncology Dispensary, Saint Petersburg, Russian Federation.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zholudeva', 'Affiliation': 'Regional Transcarpathian Oncological Dispensary, Uzhgorod, Ukraine.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Daste', 'Affiliation': 'Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Caballero-Daroqui', 'Affiliation': 'Department of Oncology, Hospital Universitario La Fe, Valencia, Spain.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Keam', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Vynnychenko', 'Affiliation': 'Sumy State University, Sumy Regional Oncology Center, Sumy, Ukraine.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lafond', 'Affiliation': 'Department of Oncology, Clinique Victor Hugo/Centre Jean Bernard, Le Mans, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Shetty', 'Affiliation': 'Late-stage ImmunoOncology, AstraZeneca, Gaithersburg, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Mann', 'Affiliation': 'Research and Development Oncology, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': 'Late-stage ImmunoOncology, AstraZeneca, Gaithersburg, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wildsmith', 'Affiliation': 'Research and Development Oncology, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Morsli', 'Affiliation': 'Research and Development Oncology, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Fayette', 'Affiliation': 'Department of Medical Oncology, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Licitra', 'Affiliation': 'Head & Neck Medical Oncology, Fondazione IRCCS Istituto Nazionale Tumori Milano, University of Milan, Milan, Italy. Electronic address: lisa.licitra@istitutotumori.mi.it.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.04.001']
415,31981043,Endoscopic Argon Plasma Coagulation vs. Multidisciplinary Evaluation in the Management of Weight Regain After Gastric Bypass Surgery: a Randomized Controlled Trial with SHAM Group.,"BACKGROUND


Roux-en-Y gastric bypass is one of the most widely performed bariatric surgeries. However, the relapse of obesity occurs in approximately 20% of patients and enlargement of the anastomosis is one of the factors associated with this relapse. Endoscopic treatment of the anastomosis has been proposed to assist in renewed weight loss. One endoscopic technique is the narrowing of the anastomosis argon plasma coagulation (APC).
OBJECTIVE


Evaluate the effectiveness and safety of the endoscopic treatment of an enlarged anastomosis with APC.
METHODS


A randomized controlled study was conducted comparing APC to exclusive multidisciplinary management after weight regain.
RESULTS


Forty-two patients were divided into two groups: APC (n = 22) and control (n = 20). After 14 months of follow-up with a crossover at 6 months, significant improvement in satiety and greater weight loss were found in the APC group and after crossover. APC was associated with significant weight loss [9.73 (7.46, 12) vs. + 1.38 (- 1.39, 2.15)], a reduction in the anastomosis diameter [p < 0.001], early satiation [0.77 (0.44, 1.11) vs. - 0.59 (- 0.95, - 0.23), p < 0.001], and increased quality of life measured using the EQ5D index [p = 0.04] and EQ5D VAS scale [p = 0.04]. Considering total mean weight loss throughout the entire follow-up, weight loss was similar in both groups (13.02 kg in the APC and 11.52 kg in the control).
CONCLUSION


Treatment of the gastrojejunal anastomosis with APC was effective and safe, with significant weight loss, the return of early satiation, and an improvement in quality of life.",2020,"Considering total mean weight loss throughout the entire follow-up, weight loss was similar in both groups (13.02 kg in the APC and 11.52 kg in the control).
","['After Gastric Bypass Surgery', 'Forty-two patients']","['Endoscopic Argon Plasma Coagulation vs. Multidisciplinary Evaluation', 'APC', 'SHAM']","['quality of life', 'satiety and greater weight loss', 'weight loss', 'EQ5D VAS scale', 'effectiveness and safety', 'total mean weight loss', 'weight loss, the return of early satiation', 'relapse of obesity occurs', 'Weight Regain']","[{'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1879736', 'cui_str': 'Argon Beam Coagulation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0034380'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0222045'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",42.0,0.0503247,"Considering total mean weight loss throughout the entire follow-up, weight loss was similar in both groups (13.02 kg in the APC and 11.52 kg in the control).
","[{'ForeName': 'Luiz Gustavo', 'Initials': 'LG', 'LastName': 'de Quadros', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil. Gustavo_quadros@hotmail.com.'}, {'ForeName': 'Manoel Galvão', 'Initials': 'MG', 'LastName': 'Neto', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'João Caetano', 'Initials': 'JC', 'LastName': 'Marchesini', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Teixeira', 'Affiliation': 'Orlando Health Hospital, Orlando, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Grecco', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'Roberto Luiz Kaiser', 'Initials': 'RLK', 'LastName': 'Junior', 'Affiliation': 'Beneficência Portuguesa Hospital, Sao Jose do Rio Preto, São Paulo, Brazil.'}, {'ForeName': 'Natan', 'Initials': 'N', 'LastName': 'Zundel', 'Affiliation': 'Jackson North Medical Center, University at Buffalo, Miami, USA.'}, {'ForeName': 'Idiberto José Zotarelli', 'Initials': 'IJZ', 'LastName': 'Filho', 'Affiliation': 'Kaiser Day Hospital, Sao Jose do Rio Preto, São Paulo, Brazil.'}, {'ForeName': 'Thiago Ferreira', 'Initials': 'TF', 'LastName': 'de Souza', 'Affiliation': 'Hospital das Clínicas da Faculdade de Medicina, Universidade de São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Admar Concon', 'Initials': 'AC', 'LastName': 'Filho', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'Lyz Bezerra', 'Initials': 'LB', 'LastName': 'da Silva', 'Affiliation': 'Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Almino Cardoso', 'Initials': 'AC', 'LastName': 'Ramos', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'Álvaro Antônio Bandeira', 'Initials': 'ÁAB', 'LastName': 'Ferraz', 'Affiliation': 'Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Josemberg Marins', 'Initials': 'JM', 'LastName': 'Campos', 'Affiliation': 'Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}]",Obesity surgery,['10.1007/s11695-020-04414-6']
416,32122921,Genomic Variants of Cytarabine Sensitivity Associated with Treatment-Related Mortality in Pediatric AML: A Report from the Children's Oncology Group.,"PURPOSE


Cytarabine is an effective treatment for AML with associated toxicities including treatment related mortality (TRM). The purpose is to determine the clinical relevance of SNPs identified through the use of HapMap lymphoblastoid cell-based models, in predicting cytarabine response and toxicity in AML.
EXPERIMENTAL DESIGN


We tested clinical significance of SNPs associated with cytarabine sensitivity in children with AML treated on Children's Oncology Group regimens (CCG 2941/2961). Endpoints included overall survival (OS), event-free survival (EFS), and TRM. Patients who received bone marrow transplant were excluded. We tested 124 SNPs associated with cytarabine sensitivity in HapMap cell lines in 348 children to determine whether any associated with treatment outcomes. In addition, we tested five SNPs previously associated with TRM in children with AML in our independent dataset of 385 children.
RESULTS


Homozygous variant genotypes of rs2025501 and rs6661575 had increased  in vitro  cellular sensitivity to cytarabine and were associated with increased TRM. TRM was particularly increased in children with variant genotype randomized to high-dose cytarabine (rs2025501:  P  = 0.0024 and rs6661575  P  = 0.0188). In analysis of previously reported SNPs, only the variant genotype rs17202778 C/C was significantly associated with TRM ( P  < 0.0001).
CONCLUSIONS


We report clinical importance of two SNPs not previously associated with cytarabine toxicity. Moreover, we confirm that SNP rs17202778 significantly impacts TRM in pediatric AML. Cytarabine sensitivity genotypes may predict TRM and could be used to stratify to standard versus high-dose cytarabine regimens, warranting further study in prospective AML trials.",2020,"RESULTS


Homozygous variant genotypes of rs2025501 and rs6661575 had increased  in vitro  cellular sensitivity to cytarabine and were associated with increased TRM.","[""children with AML treated on Children's Oncology Group regimens (CCG 2941/2961"", '348 children', 'pediatric AML', 'Patients who received bone marrow transplant were excluded']","['cytarabine', 'Cytarabine']","['TRM', 'cytarabine toxicity', 'overall survival (OS), event free survival (EFS) and TRM']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",385.0,0.0445535,"RESULTS


Homozygous variant genotypes of rs2025501 and rs6661575 had increased  in vitro  cellular sensitivity to cytarabine and were associated with increased TRM.","[{'ForeName': 'Christine L', 'Initials': 'CL', 'LastName': 'Phillips', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio. Christine.phillips@cchmc.org.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Lane', 'Affiliation': ""Division of Biostatics and Epidemiology, Cincinnati Children's Hospital, Cincinnati, Ohio.""}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Gerbing', 'Affiliation': ""Children's Oncology Group, Arcadia, California.""}, {'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Alonzo', 'Affiliation': 'University of Southern California, Los Angeles, California.'}, {'ForeName': 'Alyss', 'Initials': 'A', 'LastName': 'Wilkey', 'Affiliation': ""Cancer and Blood Diseases Institute, Cincinnati Children's Hospital, Cincinnati Ohio.""}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Radloff', 'Affiliation': ""Cancer and Blood Diseases Institute, Cincinnati Children's Hospital, Cincinnati Ohio.""}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Lange', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Gamazon', 'Affiliation': 'Vanderbilt Genetics Institute and the Division of Genetic Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'M Eileen', 'Initials': 'ME', 'LastName': 'Dolan', 'Affiliation': 'Section of Hematology/Oncology, The University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Stella M', 'Initials': 'SM', 'LastName': 'Davies', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-3117']
417,32291291,Preventing sickness absence among employees with common mental disorders or stress-related symptoms at work: a cluster randomised controlled trial of a problem-solving-based intervention conducted by the Occupational Health Services.,"OBJECTIVES


Common mental disorders (CMDs) are among the main causes of sickness absence and can lead to suffering and high costs for individuals, employers and the society. The occupational health service (OHS) can offer work-directed interventions to support employers and employees. The aim of this study was to evaluate the effect on sickness absence and health of a work-directed intervention given by the OHS to employees with CMDs or stress-related symptoms.
METHODS


Randomisation was conducted at the OHS consultant level and each consultant was allocated into either giving a brief problem-solving intervention (PSI) or care as usual (CAU). The study group consisted of 100 employees with stress symptoms or CMDs. PSI was highly structured and used a participatory approach, involving both the employee and the employee's manager. CAU was also work-directed but not based on the same theoretical concepts as PSI. Outcomes were assessed at baseline, at 6 and at 12 months. Primary outcome was registered sickness absence during the 1-year follow-up period. Among the secondary outcomes were self-registered sickness absence, return to work (RTW) and mental health.
RESULTS


A statistical interaction for group × time was found on the primary outcome (p=0.033) and PSI had almost 15 days less sickness absence during follow-up compared with CAU. Concerning the secondary outcomes, PSI showed an earlier partial RTW and the mental health improved in both groups without significant group differences.
CONCLUSION


PSI was effective in reducing sickness absence which was the primary outcome in this study.",2020,"Concerning the secondary outcomes, PSI showed an earlier partial RTW and the mental health improved in both groups without significant group differences.
","['100 employees with stress symptoms or CMDs', 'Randomisation was conducted at the OHS consultant level and each consultant was allocated into either', 'employees with common mental disorders or stress-related symptoms at work', 'employees with CMDs or stress-related symptoms', 'Common mental disorders (CMDs']","['CAU', 'giving a brief problem-solving intervention (PSI) or care as usual (CAU']","['earlier partial RTW and the mental health', 'sickness absence', 'self-registered sickness absence, return to work (RTW) and mental health', 'registered sickness absence']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0028801', 'cui_str': 'Occupational health service'}, {'cui': 'C0009817', 'cui_str': 'Consultant'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0043227', 'cui_str': 'Working'}]","[{'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]",100.0,0.155075,"Concerning the secondary outcomes, PSI showed an earlier partial RTW and the mental health improved in both groups without significant group differences.
","[{'ForeName': 'Marijke', 'Initials': 'M', 'LastName': 'Keus van de Poll', 'Affiliation': 'Division of Intervention and Implementation Research in Worker Health, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden marijke.keus.van.de.poll@ki.se.'}, {'ForeName': 'Lotta', 'Initials': 'L', 'LastName': 'Nybergh', 'Affiliation': 'Division of Intervention and Implementation Research in Worker Health, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Lornudd', 'Affiliation': 'Department of Learning, Informatics, Management and Ethics (LIME), Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hagberg', 'Affiliation': 'Division of Intervention and Implementation Research in Worker Health, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Bodin', 'Affiliation': 'Division of Intervention and Implementation Research in Worker Health, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Kwak', 'Affiliation': 'Division of Intervention and Implementation Research in Worker Health, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Jensen', 'Affiliation': 'Division of Intervention and Implementation Research in Worker Health, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Lohela-Karlsson', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Margareta', 'Initials': 'M', 'LastName': 'Torgén', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Bergstrom', 'Affiliation': 'Division of Intervention and Implementation Research in Worker Health, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden.'}]",Occupational and environmental medicine,['10.1136/oemed-2019-106353']
418,32290297,Effectiveness of a Flexible and Continuous Case Management Program for Suicide Attempters.,"The purpose of this study was to investigate the effect of continuous case management with a flexible approach on the prevention of suicide by suicide reattempt in a real clinical setting. The subjects in this study were 526 suicide attempters who visited emergency rooms in a teaching hospital in South Korea. Subjects were provided a continuous case management program with a flexible approach according to the severity of their suicide risk and needs. During the entire observation period (from 182 days to 855 days, mean = 572 ± 254), 18 patients (3.7%) died by suicide reattempt: Eight patients (2.27%) in the case management group and 10 patients (7.35%) in the no-case management group. The Cox regression analysis showed that the case management group had a 75% lower risk of death from suicide attempts than the no-case management group (HR = 0.34, 95% CI = 0.13-0.87). This result was shown to be more robust after adjusting for confounding factors such as gender, age, psychiatric treatment, suicide attempts, and family history of suicide (adjusted HR = 0.27, 95% CI = 0.09-0.83). This study was conducted in a single teaching hospital and not a randomized controlled one. A flexible and continuous case management program for suicide attempters is effective for preventing death by suicide reattempts.",2020,"The Cox regression analysis showed that the case management group had a 75% lower risk of death from suicide attempts than the no-case management group (HR = 0.34, 95% CI = 0.13-0.87).","['526 suicide attempters who visited emergency rooms in a teaching hospital in South Korea', 'Suicide Attempters']","['Flexible and Continuous Case Management Program', 'continuous case management with a flexible approach']",['risk of death from suicide attempts'],"[{'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}]","[{'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0085971', 'cui_str': 'Case management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt'}]",,0.0212233,"The Cox regression analysis showed that the case management group had a 75% lower risk of death from suicide attempts than the no-case management group (HR = 0.34, 95% CI = 0.13-0.87).","[{'ForeName': 'Min-Hyuk', 'Initials': 'MH', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Yonsei University Wonju College of Medicine, Wonju 26426, Korea.'}, {'ForeName': 'Jinhee', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Yonsei University Wonju College of Medicine, Wonju 26426, Korea.'}, {'ForeName': 'Hyunjean', 'Initials': 'H', 'LastName': 'Noh', 'Affiliation': 'Hopefull Psychiatric Clinic, Anyang, Korea.'}, {'ForeName': 'Jin-Pyo', 'Initials': 'JP', 'LastName': 'Hong', 'Affiliation': 'Department of Psychiatry, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Hyun', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Emergency Medicine, Yonsei University Wonju College of Medicine, Wonju 26426, Korea.'}, {'ForeName': 'Yong Sung', 'Initials': 'YS', 'LastName': 'Cha', 'Affiliation': 'Department of Emergency Medicine, Yonsei University Wonju College of Medicine, Wonju 26426, Korea.'}, {'ForeName': 'Joung-Sook', 'Initials': 'JS', 'LastName': 'Ahn', 'Affiliation': 'Department of Psychiatry, Yonsei University Wonju College of Medicine, Wonju 26426, Korea.'}, {'ForeName': 'Sei-Jin', 'Initials': 'SJ', 'LastName': 'Chang', 'Affiliation': 'Department of Preventive Medicine, Yonsei University Wonju College of Medicine, Wonju 26426, Korea.'}, {'ForeName': 'Seongho', 'Initials': 'S', 'LastName': 'Min', 'Affiliation': 'Department of Psychiatry, Yonsei University Wonju College of Medicine, Wonju 26426, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17072599']
419,32289804,A Single Motivational Lecture Can Promote Modest Weight Loss: A Randomized Controlled Trial.,"BACKGROUND


Obesity is a public health problem worldwide. To widely disseminate weight-loss interventions across the target population, a cost-effective approach is needed.
OBJECTIVE


We aimed to test whether a single motivational lecture could promote weight loss.
METHODS


Our study was a 3-month randomized controlled trial, and we recruited participants via local newspaper advertisements in 3 cities in Ibaraki Prefecture, Japan, and randomly assigned them to a control group (no intervention) and an intervention group, who attended a single motivational lecture lasting approximately 2 h. No other lectures or textbooks were provided. The eligibility criteria included an age of 40-64 years, a body mass index (BMI) of 25-40 kg/m2, and the presence of at least 1 component of metabolic syndrome. The primary outcome was body weight change at 3 months.
RESULTS


We enrolled 145 eligible participants with a mean age of 53.8 ± 7.1 years and a BMI of 28.5 ± 3.1 kg/m2. The 3-month body weight change in the control and intervention groups was -0.65 kg (95% confidence interval [CI] -1.09 to -0.20) and -2.48 kg (95% CI -3.01 to -1.95), respectively. The between-group difference was 1.83 kg (95% CI 1.15-2.51).
CONCLUSIONS


The significant difference suggested that a single motivational lecture is an effective option to promote modest weight loss in the short term.",2020,"The 3-month body weight change in the control and intervention groups was -0.65 kg (95% confidence interval [CI] -1.09 to -0.20) and -2.48 kg (95% CI -3.01 to -1.95), respectively.","['participants via local newspaper advertisements in 3 cities in Ibaraki Prefecture, Japan', '145 eligible participants with a mean age of 53.8 ± 7.1 years and a BMI of 28.5 ± 3.1 kg/m2', 'The eligibility criteria included an age of 40-64 years, a body mass index (BMI) of 25-40 kg/m2, and the presence of at least 1 component of metabolic syndrome']","['Motivational Lecture', 'control group (no intervention) and an intervention group, who attended a single motivational lecture lasting approximately 2 h', 'single motivational lecture']","['body weight change at 3 months', 'Modest Weight Loss', 'weight loss', '3-month body weight change']","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0027989', 'cui_str': 'Newspapers'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517678', 'cui_str': '28.5'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}]","[{'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",145.0,0.202298,"The 3-month body weight change in the control and intervention groups was -0.65 kg (95% confidence interval [CI] -1.09 to -0.20) and -2.48 kg (95% CI -3.01 to -1.95), respectively.","[{'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Nakata', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba, Japan, nakata.yoshio.gn@u.tsukuba.ac.jp.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Sasai', 'Affiliation': 'Graduate School of Arts and Sciences, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Takehiko', 'Initials': 'T', 'LastName': 'Tsujimoto', 'Affiliation': 'Faculty of Human Sciences, Shimane University, Matsue, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Hashimoto', 'Affiliation': 'Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Kobayashi', 'Affiliation': 'Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}]",Obesity facts,['10.1159/000506813']
420,32290072,"The Effect of Active Plus, a Computer-Tailored Physical Activity Intervention, on the Physical Activity of Older Adults with Chronic Illness(es)-A Cluster Randomized Controlled Trial.","eHealth interventions aimed at improving physical activity (PA) can reach large populations with few resources and demands on the population as opposed to centre-based interventions. Active Plus is a proven effective computer-tailored PA intervention for the older adult population focusing on PA in daily life. This manuscript describes the effects of the Active Plus intervention ( N  = 260) on PA of older adults with chronic illnesses (OACI), compared to a waiting list control group ( N  = 325). It was part of a larger randomized controlled trial (RCT) on the effects of the Active Plus intervention on cognitive functioning. OACI (≥65 years) with at least one chronic illness were allocated to one of the conditions. Intervention group participants received PA advice. Baseline and follow-up measurements were assessed after 6 and 12 months. Intervention effects on objectively measured light PA (LPA) and moderate-to-vigorous PA (MVPA) min/week were analysed with multilevel linear mixed-effects models adjusted for the clustered design. Intervention effects on self-reported MVPA min/week on common types of PA were analysed with two-part generalized linear mixed-effects models adjusted for the clustered design. The dropout rate was 19.1% after 6 months and 25.1% after 12 months. Analyses showed no effects on objectively measured PA. Active Plus increased the likelihood to perform self-reported cycling and gardening at six months and participants who cycled increased their MVPA min/week of cycling. Twelve months after baseline the intervention increased the likelihood to perform self-reported walking and participants who cycled at 12 months increased their MVPA min/week of cycling. Subgroup analyses showed that more vulnerable participants (higher degree of impairment, age or body mass index) benefitted more from the intervention on especially the lower intensity PA outcomes. In conclusion, Active Plus only increased PA behaviour to a limited extent in OACI 6 and 12 months after baseline measurements. The Active Plus intervention may yet be not effective enough by itself in OACI. A blended approach, where this eHealth intervention and face-to-face contact are combined, is advised to improve the effects of Active Plus on PA in this target group.",2020,Twelve months after baseline the intervention increased the likelihood to perform self-reported walking and participants who cycled at 12 months increased their MVPA min/week of cycling.,"['group ( N  = 325', '≥65 years) with at least one chronic illness', 'Older Adults with Chronic Illness(es)-A Cluster', 'older adults with chronic illnesses (OACI']","['PA advice', 'waiting list control', 'Active Plus, a Computer-Tailored Physical Activity Intervention', 'OACI', 'Active Plus intervention']","['objectively measured light PA (LPA) and moderate-to-vigorous PA (MVPA', 'cognitive functioning', 'PA behaviour', 'dropout rate']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517714', 'cui_str': '325'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0837253,Twelve months after baseline the intervention increased the likelihood to perform self-reported walking and participants who cycled at 12 months increased their MVPA min/week of cycling.,"[{'ForeName': 'Esmee', 'Initials': 'E', 'LastName': 'Volders', 'Affiliation': 'Faculty of Psychology, Open University of The Netherlands, 6419 AT Heerlen, The Netherlands.'}, {'ForeName': 'Catherine A W', 'Initials': 'CAW', 'LastName': 'Bolman', 'Affiliation': 'Faculty of Psychology, Open University of The Netherlands, 6419 AT Heerlen, The Netherlands.'}, {'ForeName': 'Renate H M', 'Initials': 'RHM', 'LastName': 'de Groot', 'Affiliation': 'Faculty of Educational Sciences, Open University of The Netherlands, 6419 AT Heerlen, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Verboon', 'Affiliation': 'Faculty of Psychology, Open University of The Netherlands, 6419 AT Heerlen, The Netherlands.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Lechner', 'Affiliation': 'Faculty of Psychology, Open University of The Netherlands, 6419 AT Heerlen, The Netherlands.'}]",International journal of environmental research and public health,['10.3390/ijerph17072590']
421,32290266,SettleIN: Using a Manualised Intervention to Facilitate the Adjustment of Older Adults with Dementia Following Placement into Residential Care.,"The authors examined the feasibility of delivering an adapted version of SettleIN, a manualised staff-led programme designed to facilitate adjustment to care for new residents with dementia. The effects of SettleIN on resident adjustment, mood and quality of life were also investigated. A pilot randomised controlled trial was conducted. Nineteen new residents with dementia and 21 staff participants were recruited. Residents were randomly assigned to receive the SettleIN programme or residential care as usual. Resident quality of life, mood and overall adjustment were measured at baseline and post-intervention, in week seven. Interviews were conducted with staff in week seven to explore intervention feasibility. Despite medium to large effect sizes, there was no significant difference in mean change scores between the two conditions, with regards to quality of life, psychological wellbeing or overall adjustment outcomes. Qualitative feedback indicated that SettleIN was not feasible across all areas, with problems around recruitment and practicality. However, SettleIN was deemed feasible in terms of retention and acceptability among staff. The majority of staff felt that SettleIN was beneficial for residents but that organisational and programme factors impacted upon intervention feasibility. Further exploration of organisational barriers is needed in order to reduce the impact of such factors on care home research.",2020,"Despite medium to large effect sizes, there was no significant difference in mean change scores between the two conditions, with regards to quality of life, psychological wellbeing or overall adjustment outcomes.","['new residents with dementia', 'Nineteen new residents with dementia and 21 staff participants were recruited', 'Older Adults with Dementia Following Placement into Residential Care']","['SettleIN programme or residential care as usual', 'Manualised Intervention']","['quality of life, psychological wellbeing or overall adjustment outcomes', 'mean change scores', 'Resident quality of life, mood and overall adjustment', 'resident adjustment, mood and quality of life']","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",,0.089169,"Despite medium to large effect sizes, there was no significant difference in mean change scores between the two conditions, with regards to quality of life, psychological wellbeing or overall adjustment outcomes.","[{'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Saint-Bryant', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, 1-19 Torrington Place, London WC1E 7HB, UK.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Murrill', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, 1-19 Torrington Place, London WC1E 7HB, UK.'}, {'ForeName': 'Janine K', 'Initials': 'JK', 'LastName': 'Hayward', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, 1-19 Torrington Place, London WC1E 7HB, UK.'}, {'ForeName': 'Kayleigh-Marie', 'Initials': 'KM', 'LastName': 'Nunez', 'Affiliation': 'Wolfson Centre for Age Related Diseases, Kings College London, Wolfson Wing, Hodgkin Building, Guys Campus, London SE1 1UL, UK.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Spector', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, 1-19 Torrington Place, London WC1E 7HB, UK.'}]",International journal of environmental research and public health,['10.3390/ijerph17072606']
422,32290136,Strength plus Endurance Training and Individualized Diet Reduce Fat Mass in Overweight Subjects: A Randomized Clinical Trial.,"Studies with overweight people are a priority in order to observe the effect of the timing of intervention on pre-obesity people. The aim was to compare different physical activity programs plus an individualized hypocaloric diet on body composition in overweight subjects. A randomized controlled clinical trial was carried out in overweight adults with no history of relevant illness. Primary outcome was total fat mass (TFM). Participants were allocated into four activity programs with equal intensity and volume of exercise for 22 weeks: strength training (S), endurance training (E), strength + endurance training (SE), and 'adhering to physical activity recommendations' (C). Participants followed a diet with 25% less energy (50%-55% carbohydrates, 30%-35% fat) measured by accelerometer. Variables were assessed at baseline and at the end of the intervention. Body composition was measured by dual-energy X-ray absorptiometry. One hundred nineteen from 205 subjects were randomized in the four exercise groups (S = 30/E = 30/SE = 30/C = 29) and 84 participants (36 men/48 women) ended the intervention (S = 19/E = 25/SE = 22/C = 18). At the end of the experiment, all groups except C increased their total physical activity (S = 1159 ± 1740; E = 1625 ± 1790; SE = 1699 ± 2516; C = 724 ± 1979 MET-min/week). Using an ANOVA-test, improvements were observed in body weight (S = -4.6 ± 4.5; E = -6.6 ± 4.6; SE = -8.5 ± 2.8; C = -6.1 ± 5.6 kg,  p  = 0.059) and TFM (S = -4.24 ± 2.02; E = -4.74 ± 2.96; SE = -6.74 ± 3.27; C = -3.94 ± 4.18%;  p  < 0.05). The main conclusion was that there were no adverse events. Strength and endurance training with a balanced, individualized hypocaloric diet was the most effective at reducing weight loss and fat mass in overweight subjects. Trial registration: NCT01116856.",2020,"Strength and endurance training with a balanced, individualized hypocaloric diet was the most effective at reducing weight loss and fat mass in overweight subjects.","['One hundred nineteen from 205 subjects', 'overweight adults with no history of relevant illness', 'Overweight Subjects', 'overweight subjects']","['Strength plus Endurance Training and Individualized Diet', 'physical activity programs plus an individualized hypocaloric diet', ""activity programs with equal intensity and volume of exercise for 22 weeks: strength training (S), endurance training (E), strength + endurance training (SE), and 'adhering to physical activity recommendations' (C"", 'Strength and endurance training with a balanced, individualized hypocaloric diet']","['total fat mass (TFM', 'body composition', 'total physical activity', 'weight loss and fat mass', 'Body composition', 'body weight']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205415', 'cui_str': 'Balanced'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",36.0,0.0451208,"Strength and endurance training with a balanced, individualized hypocaloric diet was the most effective at reducing weight loss and fat mass in overweight subjects.","[{'ForeName': 'Pedro J', 'Initials': 'PJ', 'LastName': 'Benito', 'Affiliation': 'LFE Research Group, Department of Health and Human Performance, Faculty of Physical Activity and Sport Science-INEF, Universidad Politécnica de Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Bricia', 'Initials': 'B', 'LastName': 'López-Plaza', 'Affiliation': 'Department of Nutrition, Hospital La Paz Health Research Institute (IdiPAZ), La Paz University Hospital, 28046 Madrid, Spain.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Bermejo', 'Affiliation': 'Department of Nutrition, Hospital La Paz Health Research Institute (IdiPAZ), La Paz University Hospital, 28046 Madrid, Spain.'}, {'ForeName': 'Ana B', 'Initials': 'AB', 'LastName': 'Peinado', 'Affiliation': 'LFE Research Group, Department of Health and Human Performance, Faculty of Physical Activity and Sport Science-INEF, Universidad Politécnica de Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Cupeiro', 'Affiliation': 'LFE Research Group, Department of Health and Human Performance, Faculty of Physical Activity and Sport Science-INEF, Universidad Politécnica de Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Butragueño', 'Affiliation': 'LFE Research Group, Department of Health and Human Performance, Faculty of Physical Activity and Sport Science-INEF, Universidad Politécnica de Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Rojo-Tirado', 'Affiliation': 'LFE Research Group, Department of Health and Human Performance, Faculty of Physical Activity and Sport Science-INEF, Universidad Politécnica de Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Domingo', 'Initials': 'D', 'LastName': 'González-Lamuño', 'Affiliation': 'Laboratory of Pediatrics, Department of Medical and Surgery Sciences, Faculty of Medicine, University of Cantabria, Marqués de Valdecilla Biomedical Research Institute (IDIVAL), 39011 Santander, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Gómez-Candela', 'Affiliation': 'Department of Nutrition, Hospital La Paz Health Research Institute (IdiPAZ), La Paz University Hospital, 28046 Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': 'On Behalf Of The Pronaf Study Group', 'Affiliation': ''}]",International journal of environmental research and public health,['10.3390/ijerph17072596']
423,32290148,"Effects of Aerobic-, Anaerobic- and Combined-Based Exercises on Plasma Oxidative Stress Biomarkers in Healthy Untrained Young Adults.","Currently, it is well accepted that physical exercise-induced oxidative stress may damage biological structures and impair cellular functions. However, it is still unclear which type of exercise results in the greatest oxidative stress responses among a healthy untrained population. The aim of the present study was to compare the acute oxidative stress response (i.e., 0 to 20 min) following different types of exercise (anaerobic, aerobic, and combined). Ten healthy, untrained males (19.5 ± 1.7 years) performed three randomized exercise bouts: anaerobic (30 s Wingate test), aerobic (30 min at 60% maximal aerobic power (MAP)) or combined (anaerobic and aerobic). Venous blood samples were collected before, as well as at 0 (P0), 5 (P5), 10 (P10), and 20 (P20) min after each session. Rates of malondialdehyde (MDA) and antioxidant activities (i.e., glutathione peroxidase (GPX), superoxide dismutase (SOD), glutathione reductase (GR), α-tocopherol, and total antioxidant status (TAS)) were assessed. Independent of exercise type, plasma MDA, GPX, SOD, and GR contents increased above baseline, whereas plasma α-tocopherol decreased under baseline after the test sessions ( p  < 0.05). Aerobic and anaerobic exercises generated faster responses (at P0) when compared to the combined exercise (P5 to P10) for the majority of the tested parameters. Plasma TAS content only increased following the aerobic exercise at P10 ( p  = 0.03). Five to twenty-minutes post exercise, the highest MDA response was registered in the aerobic condition, and the highest GPX and SOD responses were recorded in the anaerobic (at P5) and aerobic (at P20) conditions ( p  < 0.05). In conclusion, aerobic, anaerobic, or combined exercises have the potential to acutely increase oxidative stress and antioxidant activities, but with different responses magnitude. These findings confirm that oxidative stress response seems to be dependent on the intensity and the duration of the physical exercise and may help in understanding how varying exercise bouts influence the degree of oxidative stress among healthy untrained young adults.",2020,"Rates of malondialdehyde (MDA) and antioxidant activities (i.e., glutathione peroxidase (GPX), superoxide dismutase (SOD), glutathione reductase (GR), α-tocopherol, and total antioxidant status (TAS)) were assessed.","['healthy untrained young adults', 'healthy untrained population', 'Healthy Untrained Young Adults', 'Ten healthy, untrained males (19.5 ± 1.7 years) performed three']","['Aerobic-, Anaerobic- and Combined-Based Exercises', 'exercise (anaerobic, aerobic, and combined', 'Aerobic and anaerobic exercises', 'randomized exercise bouts: anaerobic (30 s Wingate test), aerobic (30 min at 60% maximal aerobic power (MAP)) or combined (anaerobic and aerobic']","['Plasma Oxidative Stress Biomarkers', 'Venous blood samples', 'highest MDA response', 'oxidative stress and antioxidant activities', 'plasma MDA, GPX, SOD, and GR contents', 'Rates of malondialdehyde (MDA) and antioxidant activities (i.e., glutathione peroxidase (GPX), superoxide dismutase (SOD), glutathione reductase (GR), α-tocopherol, and total antioxidant status (TAS', 'Plasma TAS content', 'highest GPX and SOD responses', 'acute oxidative stress response', 'plasma α-tocopherol']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0017824', 'cui_str': 'Glutathione reductase (NAD(P)H)'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0559483', 'cui_str': 'Pentalogy of Cantrell'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]",,0.0476807,"Rates of malondialdehyde (MDA) and antioxidant activities (i.e., glutathione peroxidase (GPX), superoxide dismutase (SOD), glutathione reductase (GR), α-tocopherol, and total antioxidant status (TAS)) were assessed.","[{'ForeName': 'Achraf', 'Initials': 'A', 'LastName': 'Ammar', 'Affiliation': 'Institute of Sport Science, Otto-von-Guericke-University Magdeburg, 39106 Magdeburg, Germany.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Trabelsi', 'Affiliation': ""Institut Supérieur du Sport et de l'Education Physique de Sfax, Université de Sfax, Sfax 3000, Tunisia.""}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Boukhris', 'Affiliation': ""Institut Supérieur du Sport et de l'Education Physique de Sfax, Université de Sfax, Sfax 3000, Tunisia.""}, {'ForeName': 'Jordan M', 'Initials': 'JM', 'LastName': 'Glenn', 'Affiliation': 'Neurotrack Technologies, Redwood City, CA 94063, USA.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Bott', 'Affiliation': 'Neurotrack Technologies, Redwood City, CA 94063, USA.'}, {'ForeName': 'Liwa', 'Initials': 'L', 'LastName': 'Masmoudi', 'Affiliation': ""Institut Supérieur du Sport et de l'Education Physique de Sfax, Université de Sfax, Sfax 3000, Tunisia.""}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hakim', 'Affiliation': 'Laboratory of Pharmacology, Faculty of Medicine, Sfax University, Sfax 3029, Tunisia.'}, {'ForeName': 'Hamdi', 'Initials': 'H', 'LastName': 'Chtourou', 'Affiliation': ""Institut Supérieur du Sport et de l'Education Physique de Sfax, Université de Sfax, Sfax 3000, Tunisia.""}, {'ForeName': 'Tarak', 'Initials': 'T', 'LastName': 'Driss', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical Activity, Health and Learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, 92000 Nanterre, France.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Hoekelmann', 'Affiliation': 'Institute of Sport Science, Otto-von-Guericke-University Magdeburg, 39106 Magdeburg, Germany.'}, {'ForeName': 'Kais', 'Initials': 'K', 'LastName': 'El Abed', 'Affiliation': ""Institut Supérieur du Sport et de l'Education Physique de Sfax, Université de Sfax, Sfax 3000, Tunisia.""}]",International journal of environmental research and public health,['10.3390/ijerph17072601']
424,32273234,Androgens and Overall Survival in Patients With Metastatic Castration-resistant Prostate Cancer Treated With Docetaxel.,"BACKGROUND


Pre-treatment androgen levels are associated with overall survival (OS) in patients with metastatic castration-resistant prostate cancer (CRPC) treated with androgen synthesis inhibitors. The current study sought to determine whether pre-treatment serum androgens predict clinical outcome among patients with metastatic CRPC treated with docetaxel chemotherapy.
MATERIALS AND METHODS


Data were obtained from 1050 men who were chemotherapy-naive prior to treatment with docetaxel, prednisone, and either bevacizumab or placebo (CALGB 90401). Pretreatment serum assays for testosterone, androstenedione, and dehydroepiandrosterone (DHEA) were performed with tandem liquid chromatography-mass spectrometry.
RESULTS


Median values for testosterone, androstenedione, and DHEA were 1.00, 13.50, and 8.12 ng/dL, respectively. The median was used to define the midpoint between low and high values. In univariate analysis, median OS for low versus high levels was 21.4 and 24.2 months for testosterone, 23.8 and 21.9 months for androstenedione, and 20.2 and 25.2 months for DHEA (P = NS). In multivariable analysis of all androgens, baseline DHEA was prognostic of ≥ 50% PSA decline from baseline (P = .008). In multivariable analysis adjusting for 10 known prognostic values and prior ketoconazole use for metastatic CRPC, a 10-unit increase in baseline testosterone increased risk of death (hazard ratio, 1.11; 95% confidence interval, 1.01-1.23; P = .039), whereas a 10-unit increase in androstenedione lowered risk of death (hazard ratio, 0.92; 95% confidence interval, 0.88-0.97; P = .001).
CONCLUSION


Consistent with prior studies, higher androstenedione levels in patients with metastatic CRPC treated with docetaxel are associated with improved survival. However pretreatment levels of other androgen levels are associated with varied effects on clinical outcome in chemotherapy-treated patients.",2020,"In univariate analysis, median OS for low versus high levels was 21.4 and 24.2 months for testosterone, 23.8 and 21.9 months for androstenedione, and 20.2 and 25.2 months for DHEA (P = NS).","['Data were obtained from 1050 men who were chemotherapy-naive prior to treatment with', 'patients with metastatic CRPC treated with docetaxel chemotherapy', 'Patients', 'CALGB 90401', 'patients with metastatic castration-resistant prostate cancer (CRPC) treated with', 'patients with metastatic CRPC treated with']","['Docetaxel', 'docetaxel', 'androgen synthesis inhibitors', 'docetaxel, prednisone, and either bevacizumab or placebo', 'ketoconazole']","['Median values for testosterone, androstenedione, and DHEA', 'Androgens and Overall Survival', 'overall survival (OS', 'androstenedione levels', 'survival', 'median OS', 'androstenedione lowered risk of death', 'Pretreatment serum assays for testosterone, androstenedione, and dehydroepiandrosterone (DHEA']","[{'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C4517528', 'cui_str': '1050'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C3853002', 'cui_str': 'Androgen Synthesis Inhibitors'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022625', 'cui_str': 'Ketoconazole'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0002860', 'cui_str': 'Androstenedione'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0002844', 'cui_str': 'Androgen'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0337432', 'cui_str': 'Androstenedione measurement'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}]",,0.330625,"In univariate analysis, median OS for low versus high levels was 21.4 and 24.2 months for testosterone, 23.8 and 21.9 months for androstenedione, and 20.2 and 25.2 months for DHEA (P = NS).","[{'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Ryan', 'Affiliation': 'Division of Hematology, Oncology and Transplantation University of Minnesota, Masonic Cancer Center, Minneapolis, MN. Electronic address: ryanc@umn.edu.'}, {'ForeName': 'Sandipan', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Duke University Medical Center, Durham, NC.'}, {'ForeName': 'William K', 'Initials': 'WK', 'LastName': 'Kelly', 'Affiliation': 'Department of Medical Oncology, Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Middleberg', 'Affiliation': 'NMS Labs, Willow Grove, PA.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Russell', 'Affiliation': 'Division of Hematology, Oncology and Transplantation University of Minnesota, Masonic Cancer Center, Minneapolis, MN.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Memorial Sloan Kettering Cancer, New York, NY.'}, {'ForeName': 'Mary-Ellen', 'Initials': 'ME', 'LastName': 'Taplin', 'Affiliation': 'Dana-Farber/Partners Cancer Care, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Halabi', 'Affiliation': 'Duke University Medical Center, Durham, NC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical genitourinary cancer,['10.1016/j.clgc.2019.10.002']
425,32292179,The Impact of a Tablet App on Adherence to American Heart Association Guidelines During Simulated Pediatric Cardiopulmonary Resuscitation: Randomized Controlled Trial.,"BACKGROUND


Evidence-based best practices are the cornerstone to guide optimal cardiopulmonary arrest resuscitation care. Adherence to the American Heart Association (AHA) guidelines for cardiopulmonary resuscitation (CPR) optimizes the management of critically ill patients and increases their chances of survival after cardiac arrest. Despite advances in resuscitation science and survival improvement over the last decades, only approximately 38% of children survive to hospital discharge after in-hospital cardiac arrest and only 6%-20% after out-of-hospital cardiac arrest.
OBJECTIVE


We investigated whether a mobile app developed as a guide to support and drive CPR providers in real time through interactive pediatric advanced life support (PALS) algorithms would increase adherence to AHA guidelines and reduce the time to initiation of critical life-saving maneuvers compared to the use of PALS pocket reference cards.
METHODS


This study was a randomized controlled trial conducted during a simulation-based pediatric cardiac arrest scenario caused by pulseless ventricular tachycardia (pVT). A total of 26 pediatric residents were randomized into two groups. The primary outcome was the elapsed time in seconds in each allocation group from the onset of pVT to the first defibrillation attempt. Secondary outcomes were time elapsed to (1) initiation of chest compression, (2) subsequent defibrillation attempts, and (3) administration of drugs, including the time intervals between defibrillation attempts and drug doses, shock doses, and the number of shocks. All outcomes were assessed for deviation from AHA guidelines.
RESULTS


Mean time to the first defibrillation attempt (121.4 sec, 95% CI 105.3-137.5) was significantly reduced among residents using the app compared to those using PALS pocket cards (211.5 sec, 95% CI 162.5-260.6, P<.001). With the app, 11 out of 13 (85%) residents initiated chest compressions within 60 seconds from the onset of pVT and 12 out of 13 (92%) successfully defibrillated within 180 seconds. Time to all other defibrillation attempts was reduced with the app. Adherence to the 2018 AHA pVT algorithm improved by approximately 70% (P=.001) when using the app following all CPR sequences of action in a stepwise fashion until return of spontaneous circulation. The pVT rhythm was recognized correctly in 51 out of 52 (98%) opportunities among residents using the app compared to only 19 out of 52 (37%) among those using PALS cards (P<.001). Time to epinephrine injection was similar. Among a total of 78 opportunities, incorrect shock or drug doses occurred in 14% (11/78) of cases among those using the cards. These errors were reduced to 1% (1/78, P=.005) when using the app.
CONCLUSIONS


Use of the mobile app was associated with a shorter time to first and subsequent defibrillation attempts, fewer medication and defibrillation dose errors, and improved adherence to AHA recommendations compared with the use of PALS pocket cards.",2020,"These errors were reduced by 12.8% (1/78, P =.0046) using the app.
","['Twenty-six pediatric residents', 'critically ill patients', 'American Heart Association Guidelines During Simulated Pediatric Cardiopulmonary Resuscitation']","['Mobile Device Tablet App', 'simulation-based pediatric cardiac arrest scenario-pulseless ventricular tachycardia (pVT', 'epinephrine']","['pVT rhythm', 'time elapsed to 1) initiation of chest compression, 2) subsequent defibrillation attempts, and 3) administration of drugs, including the time intervals between defibrillation attempts and drug doses, shock doses, and the number of shocks', 'Mean time', 'elapsed time in seconds']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002458', 'cui_str': 'American Heart Association'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0750196', 'cui_str': 'Pulseless ventricular tachycardia'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205436', 'cui_str': 'Second'}]",,0.0876083,"These errors were reduced by 12.8% (1/78, P =.0046) using the app.
","[{'ForeName': 'Johan N', 'Initials': 'JN', 'LastName': 'Siebert', 'Affiliation': ""Department of Pediatric Emergency Medicine, Geneva Children's Hospital, Geneva University Hospitals, Geneva, Switzerland.""}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Lacroix', 'Affiliation': ""Department of Pediatric Emergency Medicine, Geneva Children's Hospital, Geneva University Hospitals, Geneva, Switzerland.""}, {'ForeName': 'Aymeric', 'Initials': 'A', 'LastName': 'Cantais', 'Affiliation': 'Pediatric Emergency Department, University Hospital of Saint-Etienne, Saint-Etienne, France.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Manzano', 'Affiliation': ""Department of Pediatric Emergency Medicine, Geneva Children's Hospital, Geneva University Hospitals, Geneva, Switzerland.""}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Ehrler', 'Affiliation': 'Diagnostic Department, Geneva University Hospitals, Geneva, Switzerland.'}]",Journal of medical Internet research,['10.2196/17792']
426,32051147,Novel Detection and Restorative Levodopa Treatment for Preclinical Diabetic Retinopathy.,"Diabetic retinopathy (DR) is diagnosed clinically by directly viewing retinal vascular changes during ophthalmoscopy or through fundus photographs. However, electroretinography (ERG) studies in humans and rodents have revealed that retinal dysfunction is demonstrable prior to the development of visible vascular defects. Specifically, delays in dark-adapted ERG oscillatory potential (OP) implicit times in response to dim-flash stimuli (<-1.8 log cd · s/m 2 ) occur prior to clinically recognized DR. Animal studies suggest that retinal dopamine deficiency underlies these early functional deficits. In this study, we randomized individuals with diabetes, without clinically detectable retinopathy, to treatment with either low- or high-dose Sinemet (levodopa plus carbidopa) for 2 weeks and compared their ERG findings with those of control subjects (no diabetes). We assessed dim-flash-stimulated OP delays using a novel handheld ERG system (RETeval) at baseline and 2 and 4 weeks. RETeval recordings identified significant OP implicit time delays in individuals with diabetes without retinopathy compared with age-matched control subjects ( P  < 0.001). After 2 weeks of Sinemet treatment, OP implicit times were restored to control values, and these improvements persisted even after a 2-week washout. We conclude that detection of dim-flash OP delays could provide early detection of DR and that Sinemet treatment may reverse retinal dysfunction.",2020,RETeval recordings identified significant OP implicit-time delays in persons with diabetes without retinopathy compared to age-matched control s  (p<0.001).,"['persons with diabetes without retinopathy', 'persons with diabetes, without clinically detectable retinopathy, to treatment with either low or high dose Sinemet (levodopa plus carbidopa) for 2 weeks and compared their ERG findings with those of control (no DM) subjects', 'Pre-Clinical Diabetic Retinopathy']",['Novel Detection and Restorative Levodopa Treatment'],"['Diabetic retinopathy (DR', 'OP implicit-time delays', 'delays in dark-adapted ERG oscillatory potential (OP) implicit times', 'OP implicit times']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0035309', 'cui_str': 'Retinal Diseases'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0074559', 'cui_str': 'Sinemet'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0006982', 'cui_str': 'Carbidopa'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}]","[{'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332582', 'cui_str': 'Dark color (qualifier value)'}]",,0.0177311,RETeval recordings identified significant OP implicit-time delays in persons with diabetes without retinopathy compared to age-matched control s  (p<0.001).,"[{'ForeName': 'Cara T', 'Initials': 'CT', 'LastName': 'Motz', 'Affiliation': 'Center for Visual and Neurocognitive Rehabilitation, Atlanta Veterans Affairs Medical Center, Decatur, GA.'}, {'ForeName': 'Kyle C', 'Initials': 'KC', 'LastName': 'Chesler', 'Affiliation': 'Center for Visual and Neurocognitive Rehabilitation, Atlanta Veterans Affairs Medical Center, Decatur, GA.'}, {'ForeName': 'Rachael S', 'Initials': 'RS', 'LastName': 'Allen', 'Affiliation': 'Center for Visual and Neurocognitive Rehabilitation, Atlanta Veterans Affairs Medical Center, Decatur, GA.'}, {'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Bales', 'Affiliation': 'Center for Visual and Neurocognitive Rehabilitation, Atlanta Veterans Affairs Medical Center, Decatur, GA.'}, {'ForeName': 'Lukas M', 'Initials': 'LM', 'LastName': 'Mees', 'Affiliation': 'Center for Visual and Neurocognitive Rehabilitation, Atlanta Veterans Affairs Medical Center, Decatur, GA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Feola', 'Affiliation': 'Center for Visual and Neurocognitive Rehabilitation, Atlanta Veterans Affairs Medical Center, Decatur, GA.'}, {'ForeName': 'April Y', 'Initials': 'AY', 'LastName': 'Maa', 'Affiliation': 'Center for Visual and Neurocognitive Rehabilitation, Atlanta Veterans Affairs Medical Center, Decatur, GA.'}, {'ForeName': 'Darin E', 'Initials': 'DE', 'LastName': 'Olson', 'Affiliation': 'Division of Endocrinology, Metabolism and Lipids, Emory University, Atlanta, GA.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Thule', 'Affiliation': 'Division of Endocrinology, Metabolism and Lipids, Emory University, Atlanta, GA.'}, {'ForeName': 'P Michael', 'Initials': 'PM', 'LastName': 'Iuvone', 'Affiliation': 'Department of Ophthalmology, Emory University, Atlanta, GA.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Hendrick', 'Affiliation': 'Department of Ophthalmology, Emory University, Atlanta, GA.'}, {'ForeName': 'Machelle T', 'Initials': 'MT', 'LastName': 'Pardue', 'Affiliation': 'Center for Visual and Neurocognitive Rehabilitation, Atlanta Veterans Affairs Medical Center, Decatur, GA machelle.pardue@bme.gatech.edu.'}]",Diabetes,['10.2337/db19-0869']
427,32252062,"Ketamine metabolites, clinical response, and gamma power in a randomized, placebo-controlled, crossover trial for treatment-resistant major depression.","A single, subanesthetic dose of (R,S)-ketamine (ketamine) exerts rapid and robust antidepressant effects. Several groups previously reported that (2S,6S;2R,6R)-hydroxynorketamine (HNK) had antidepressant effects in rodents, and that (2R,6R)-HNK increased cortical electroencephalographic gamma power. This exploratory study examined the relationship between ketamine metabolites, clinical response, psychotomimetic symptoms, and gamma power changes in 34 individuals (ages 18-65) with treatment-resistant depression (TRD) who received a single ketamine infusion (0.5 mg/kg) over 40 min. Plasma concentrations of ketamine, norketamine, and HNKs were measured at 40, 80, 120, and 230 min and at 1, 2, and 3 days post-infusion. Linear mixed models evaluated ketamine metabolites as mediators of antidepressant and psychotomimetic effects and their relationship to resting-state whole-brain magnetoencephalography (MEG) gamma power 6-9 h post-infusion. Three salient findings emerged. First, ketamine concentration positively predicted distal antidepressant response at Day 11 post-infusion, and an inverse relationship was observed between (2S,6S;2R,6R)-HNK concentration and antidepressant response at 3 and 7 days post-infusion. Norketamine concentration was not associated with antidepressant response. Second, ketamine, norketamine, and (2S,6S;2R,6R)-HNK concentrations at 40 min were positively associated with contemporaneous psychotomimetic symptoms; post-hoc analysis revealed that ketamine was the predominant contributor. Third, increased (2S,6S;2R,6R)-HNK maximum observed concentration (C max ) was associated with increased MEG gamma power. While contrary to preclinical observations and our a priori hypotheses, these exploratory results replicate those of a recently published study documenting a relationship between higher (2S,6S;2R,6R)-HNK concentrations and weaker antidepressant response in humans and provide further rationale for studying gamma power changes as potential biomarkers of antidepressant response.",2020,Norketamine concentration was not associated with antidepressant response.,['34 individuals (ages 18-65) with treatment-resistant depression (TRD) who received a'],"['placebo', 'ketamine', 'subanesthetic dose of (R,S)-ketamine (ketamine', '2S,6S;2R,6R)-hydroxynorketamine (HNK', 'Ketamine', 'single ketamine infusion']","['Plasma concentrations of ketamine, norketamine, and HNKs', '2S,6S;2R,6R)-HNK concentration and antidepressant response', 'ketamine, norketamine, and (2S,6S;2R,6R)-HNK concentrations', 'distal antidepressant response', 'Norketamine concentration', 'cortical electroencephalographic gamma power']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0068996', 'cui_str': 'norketamine'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}]",,0.0410552,Norketamine concentration was not associated with antidepressant response.,"[{'ForeName': 'Cristan A', 'Initials': 'CA', 'LastName': 'Farmer', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Gilbert', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Ruin', 'Initials': 'R', 'LastName': 'Moaddel', 'Affiliation': 'National Institute on Aging, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'Jomy', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Clinical Pharmacokinetics Research Unit, Pharmacy Department, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Adeojo', 'Affiliation': 'Clinical Pharmacokinetics Research Unit, Pharmacy Department, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Lovett', 'Affiliation': 'National Institute on Aging, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'Allison C', 'Initials': 'AC', 'LastName': 'Nugent', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bashkim', 'Initials': 'B', 'LastName': 'Kadriu', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Peixiong', 'Initials': 'P', 'LastName': 'Yuan', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Gould', 'Affiliation': 'Departments of Psychiatry, Pharmacology, and Anatomy and Neurobiology, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Lawrence T', 'Initials': 'LT', 'LastName': 'Park', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Zarate', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA. zaratec@mail.nih.gov.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0663-6']
428,32259647,The possible use of precision tinted lenses to improve social cognition in children with autism spectrum disorders.,"A masked randomised control design compared the effectiveness of precision ophthalmic tints in improving the recognition of emotion in Autism Spectrum Disorders (ASD). Fourteen children aged 10-14 with ASD and 14 control children matched on verbal and non-verbal IQ, wore spectacles with coloured lenses to complete two tasks that involved the observation of coloured video sequences in which social interactions were depicted. On one occasion (randomly first or second) the coloured lenses provided light of a colour that the child had one month previously selected as optimal for the clarity of text. On the other occasion the lenses differed in CIE UCS chromaticity by 0.077. Performance in the ASD group was superior in both social interaction tasks with the lenses that provided the optimal colour of light.",2020,A masked randomised control design compared the effectiveness of precision ophthalmic tints in improving the recognition of emotion in Autism Spectrum Disorders (ASD).,"['children with autism spectrum disorders', 'Fourteen children aged 10-14 with ASD and 14 control children matched on verbal and non-verbal IQ, wore spectacles with coloured lenses', 'Autism Spectrum Disorders (ASD']","['precision tinted lenses', 'precision ophthalmic tints']","['CIE UCS chromaticity', 'social cognition']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0023318', 'cui_str': 'Lenses'}]","[{'cui': 'C0023318', 'cui_str': 'Lenses'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C0010214', 'cui_str': 'Countercurrent electrophoresis measurement'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",14.0,0.0151303,A masked randomised control design compared the effectiveness of precision ophthalmic tints in improving the recognition of emotion in Autism Spectrum Disorders (ASD).,"[{'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Ludlow', 'Affiliation': 'University of Hertfordshire, School of Psychology and Sports Sciences, College Lane, Hatfield AL10 9AB, United Kingdom. Electronic address: a.ludlow@herts.ac.uk.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Giannadou', 'Affiliation': 'University of Sheffield, Department of Psychology, 1 Vicar Lane, Sheffield S1 2LT, United Kingdom. Electronic address: agiannadou1@sheffield.ac.uk.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Franklin', 'Affiliation': 'University of Sussex, School of Psychology, Falmer BN1 9QH, United Kingdom. Electronic address: Anna.Franklin@sussex.ac.uk.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Allen', 'Affiliation': 'Anglia Ruskin University, Department of Vision and Hearing Sciences & Vision and Eye Research Unit, Cambridgeshire CB1 1PT, United Kingdom. Electronic address: peter.allen@anglia.ac.uk.'}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Simmons', 'Affiliation': 'University of Glasgow, School of Psychology, 62 Hillhead Street, Glasgow G12 8QB, United Kingdom. Electronic address: David.Simmons@glasgow.ac.uk.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Wilkins', 'Affiliation': 'University of Essex, Department of Psychology, Wivenhoe Park, Colchester CO4 3SQ, United Kingdom. Electronic address: arnold@essex.ac.uk.'}]",Vision research,['10.1016/j.visres.2020.03.007']
429,32108686,Prophylactic Intrathecal Morphine and Prevention of Post-Dural Puncture Headache: A Randomized Double-blind Trial.,"BACKGROUND


Prophylactic epidural morphine administration after unintentional dural puncture with a large-bore needle has been shown to decrease the incidence of post-dural puncture headache. The authors hypothesized that prophylactic administration of intrathecal morphine would decrease the incidence of post-dural puncture headache and/or need for epidural blood patch after unintentional dural puncture.
METHODS


Parturients with an intrathecal catheter in situ after unintentional dural puncture with a 17-g Tuohy needle during intended epidural catheter placement for labor analgesia were enrolled in this randomized, double-blind trial. After delivery, subjects were randomized to receive intrathecal morphine 150 µg or normal saline. The primary outcome was the incidence of post-dural puncture headache. Secondary outcomes included onset, duration, and severity of post-dural puncture headache, the presence of cranial nerve symptoms and the type of treatment the patient received.
RESULTS


Sixty-one women were included in the study. The incidence of post-dural puncture headache was 21 of 27 (78%) in the intrathecal morphine group and 27 of 34 (79%) in the intrathecal saline group (difference, -1%; 95% CI, -25% to 24%). There were no differences between groups in the onset, duration, or severity of headache, or presence of cranial nerve symptoms. Epidural blood patch was administered to 10 of 27 (37%) of subjects in the intrathecal morphine and 11 of 21 (52%) of the intrathecal saline group (difference 15%; 95% CI, -18% to 48%).
CONCLUSIONS


The present findings suggest that a single prophylactic intrathecal morphine dose of 150 µg administered shortly after delivery does not decrease the incidence or severity of post-dural puncture headache after unintentional dural puncture. This study does not support the clinical usefulness of prophylactic intrathecal morphine after an unintentional dural puncture.",2020,"There were no differences between groups in the onset, duration, or severity of headache, or presence of cranial nerve symptoms.","['unintentional dural puncture', 'Sixty-one women were included in the study', 'Post-Dural Puncture Headache', 'Parturients with an intrathecal catheter in situ after unintentional dural puncture with a 17-g Tuohy needle during intended epidural catheter placement for labor analgesia']","['prophylactic intrathecal morphine', 'intrathecal morphine', 'intrathecal saline', 'Epidural morphine', 'intrathecal morphine 150 µg or normal saline', 'Prophylactic Intrathecal Morphine']","['onset, duration, or severity of headache, or presence of cranial nerve symptoms', 'incidence or severity of post-dural puncture headache', 'onset, duration, and severity of post-dural puncture headache, the presence of cranial nerve symptoms and the type of treatment the patient received', 'Epidural blood patch', 'incidence of post-dural puncture headache']","[{'cui': 'C0919916', 'cui_str': 'Unintentional dural puncture'}, {'cui': 'C4517832', 'cui_str': 'Sixty-one'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0751188', 'cui_str': 'Post-Dural Puncture Headaches'}, {'cui': 'C2584606', 'cui_str': 'Intrathecal catheter'}, {'cui': 'C0444498', 'cui_str': 'In situ (qualifier value)'}, {'cui': 'C0050288', 'cui_str': 'A 17'}, {'cui': 'C0184186', 'cui_str': 'Tuohy epidural needle'}, {'cui': 'C3665866', 'cui_str': 'Epidural catheter placement'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0010268', 'cui_str': 'Cranial Nerves'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0751188', 'cui_str': 'Post-Dural Puncture Headaches'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162649', 'cui_str': 'Patchs, Epidural Blood'}]",61.0,0.677125,"There were no differences between groups in the onset, duration, or severity of headache, or presence of cranial nerve symptoms.","[{'ForeName': 'Feyce M', 'Initials': 'FM', 'LastName': 'Peralta', 'Affiliation': 'From the Department of Anesthesiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois (F.M.P., N.H., P.T., M.J.J.) Department of Anesthesia, University of Iowa Carver College of Medicine, Iowa City, Iowa (C.A.W.) Department of Anesthesiology, Rush University Medical Center, Chicago, Illinois (R.J.M.).'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Wong', 'Affiliation': ''}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Higgins', 'Affiliation': ''}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'Toledo', 'Affiliation': ''}, {'ForeName': 'Mary Jane', 'Initials': 'MJ', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'McCarthy', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003206']
430,32221992,Cellular immune response to acute exercise: Comparison of endurance and resistance exercise.,"OBJECTIVES


Exercise-induced cellular mobilization might play a role in treatment and prevention of several diseases. However, little is known about the impact of different exercise modalities on immune cell mobilization and clinical cellular inflammation markers. Therefore, the present study aimed to investigate differences between acute endurance exercise (EE) and resistance exercise (RE) on cellular immune alterations.
METHODS


Twenty-four healthy men conducted an acute EE (cycling at 60% of peak power output) and RE (five exercise machines at 70% of the one-repetition maximum) session lasting 50 minutes in randomized order. Blood samples were collected before, after and one hour after exercise cessation. Outcomes included counts and proportions of leukocytes, neutrophils (NEUT), lymphocytes (LYM), LYM subsets, CD4/CD8 ratio, and the clinical cellular inflammation markers NEUT/LYM ratio (NLR), platelets/LYM ratio (PLR), and systemic immune inflammation index (SII).
RESULTS


Alterations in all outcomes were revealed except for CD8 +  T cells, CD4/CD8 ratio, NLR, and PLR. EE induced a stronger cellular immune response and provoked alterations in more immune cell populations than RE. SII was altered only after EE.
CONCLUSION


An acute EE session causes a stronger mobilization of immune cells than RE. Additionally, SII represents an integrative marker to depict immunological alterations.",2020,"RESULTS


Alterations in all outcomes were revealed except for CD8 +  T cells, CD4/CD8 ratio, NLR and PLR.",['24 healthy men conducted an acute EE (cycling at 60% of peak power output) and RE (five exercise machines at 70% of the one-repetition maximum) session lasting 50 minutes in randomized order'],"['acute endurance exercise (EE) and resistance exercise (RE', 'endurance and resistance exercise']","['counts and proportions of leukocytes, neutrophils (NEUT), lymphocytes (LYM), LYM subsets, CD4/CD8 ratio and the clinical cellular inflammation markers NEUT/LYM ratio (NLR), platelets/LYM ratio (PLR) and systemic immune inflammation index (SII', 'SII', 'CD8 +  T cells, CD4/CD8 ratio, NLR and PLR']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}]","[{'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise (regime/therapy)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}]","[{'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0449199', 'cui_str': 'LYM (body structure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}]",24.0,0.0838802,"RESULTS


Alterations in all outcomes were revealed except for CD8 +  T cells, CD4/CD8 ratio, NLR and PLR.","[{'ForeName': 'Marit Lea', 'Initials': 'ML', 'LastName': 'Schlagheck', 'Affiliation': 'Department for Molecular and Cellular Sports Medicine, Institute for Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Walzik', 'Affiliation': 'Department for Molecular and Cellular Sports Medicine, Institute for Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Joisten', 'Affiliation': 'Department for Molecular and Cellular Sports Medicine, Institute for Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Koliamitra', 'Affiliation': 'Department for Molecular and Cellular Sports Medicine, Institute for Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Hardt', 'Affiliation': 'Department for Molecular and Cellular Sports Medicine, Institute for Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Metcalfe', 'Affiliation': 'Department for Molecular and Cellular Sports Medicine, Institute for Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Wahl', 'Affiliation': 'Department for Molecular and Cellular Sports Medicine, Institute for Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Bloch', 'Affiliation': 'Department for Molecular and Cellular Sports Medicine, Institute for Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Schenk', 'Affiliation': 'Department of ""Performance and Health (Sports Medicine)"", Institute of Sport and Sport Science, Technical University Dortmund, Dortmund, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Zimmer', 'Affiliation': 'Department of ""Performance and Health (Sports Medicine)"", Institute of Sport and Sport Science, Technical University Dortmund, Dortmund, Germany.'}]",European journal of haematology,['10.1111/ejh.13412']
431,32147362,Selonsertib for patients with bridging fibrosis or compensated cirrhosis due to NASH: Results from randomized phase III STELLAR trials.,"BACKGROUND & AIMS


Apoptosis signal-regulating kinase 1 (ASK1) plays a key role in hepatocyte injury, inflammation, and fibrosis in non-alcoholic steatohepatitis (NASH). We evaluated the safety and antifibrotic effect of selonsertib, a selective inhibitor of ASK1, in patients with advanced fibrosis due to NASH.
METHODS


We conducted 2 randomized, double-blind, placebo-controlled, phase III trials of selonsertib in patients with NASH and bridging fibrosis (F3, STELLAR-3) or compensated cirrhosis (F4, STELLAR-4). Patients were randomized 2:2:1 to receive selonsertib 18 mg, selonsertib 6 mg, or placebo once daily for 48 weeks. Liver biopsies were performed at screening and week 48 and non-invasive tests of fibrosis (NITs) were evaluated. The primary efficacy endpoint was the proportion of patients with ≥1-stage improvement in fibrosis without worsening of NASH at week 48. Additional endpoints included changes in NITs, progression to cirrhosis (in STELLAR-3), and liver-related clinical events.
RESULTS


Neither trial met the primary efficacy endpoint. In STELLAR-3, fibrosis improvement without worsening of NASH was observed in 10% (31/322, p = 0.49 vs. placebo), 12% (39/321, p = 0.93 vs. placebo), and 13% (21/159) of patients in the selonsertib 18 mg, selonsertib 6 mg, and placebo groups, respectively. In STELLAR-4, the primary endpoint was achieved in 14% (51/354; p = 0.56), 13% (45/351; p = 0.93), and 13% (22/172) of patients, respectively. Although selonsertib led to dose-dependent reductions in hepatic phospho-p38 expression indicative of pharmacodynamic activity, it had no significant effect on liver biochemistry, NITs, progression to cirrhosis, or adjudicated clinical events. The rates and types of adverse events were similar among selonsertib and placebo groups.
CONCLUSIONS


Forty-eight weeks of selonsertib monotherapy had no antifibrotic effect in patients with bridging fibrosis or compensated cirrhosis due to NASH.
LAY SUMMARY


Patients with non-alcoholic steatohepatitis (NASH) can develop scarring of the liver (fibrosis), including cirrhosis, which increases the risks of liver failure and liver cancer. We tested whether 48 weeks of treatment with selonsertib reduced fibrosis in patients with NASH and advanced liver scarring. We did not find that selonsertib reduced fibrosis in these patients.
TRIAL REGISTRATION DETAILS


Clinicaltrials.gov numbers NCT03053050 and NCT03053063.",2020,"Although selonsertib led to dose-dependent reductions in hepatic phospho-p38 expression indicative of pharmacodynamic activity, it had no significant effect on liver biochemistry, NITs, progression to cirrhosis, or adjudicated clinical events.","['patients with bridging fibrosis or compensated cirrhosis due to NASH', 'Patients with Bridging Fibrosis or Compensated Cirrhosis Due to NASH', 'patients with NASH and bridging fibrosis (F3, STELLAR-3) or compensated cirrhosis (F4, STELLAR-4', 'patients with advanced fibrosis due to NASH']","['selonsertib 18 mg, selonsertib 6 mg, or placebo', 'selonsertib monotherapy', 'placebo']","['changes in NITs, progression to cirrhosis (in STELLAR-3), and liver-related clinical events', 'STELLAR-3, fibrosis improvement without worsening of NASH', 'rates and types of adverse events', 'liver biochemistry, NITs, progression to cirrhosis', 'proportion of patients with ≥1-stage improvement in fibrosis without worsening of NASH']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0334160', 'cui_str': 'Bridging fibrosis (morphologic abnormality)'}, {'cui': 'C0205432', 'cui_str': 'Compensated (qualifier value)'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0562688', 'cui_str': 'Egg of order Phthiraptera (organism)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}]",,0.317529,"Although selonsertib led to dose-dependent reductions in hepatic phospho-p38 expression indicative of pharmacodynamic activity, it had no significant effect on liver biochemistry, NITs, progression to cirrhosis, or adjudicated clinical events.","[{'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Harrison', 'Affiliation': 'Pinnacle Clinical Research, San Antonio, TX, USA. Electronic address: sharrison@pinnacleresearch.com.'}, {'ForeName': 'Vincent Wai-Sun', 'Initials': 'VW', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, Hong Kong, China.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Okanoue', 'Affiliation': 'Saiseikai Suita Hospital, Suita City, Osaka, Japan.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Bzowej', 'Affiliation': 'Oschner Medical Center, New Orleans, LA, USA.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Vuppalanchi', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Ziad', 'Initials': 'Z', 'LastName': 'Younes', 'Affiliation': 'Gastro One, Germantown, TN, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Kohli', 'Affiliation': 'The Institute for Liver Health, Chandler, AZ, USA.'}, {'ForeName': 'Shiv', 'Initials': 'S', 'LastName': 'Sarin', 'Affiliation': 'Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Stephen H', 'Initials': 'SH', 'LastName': 'Caldwell', 'Affiliation': 'University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Naim', 'Initials': 'N', 'LastName': 'Alkhouri', 'Affiliation': 'Texas Liver Institute, University of Texas Health San Antonio, TX, USA.'}, {'ForeName': 'Mitchell L', 'Initials': 'ML', 'LastName': 'Shiffman', 'Affiliation': 'Liver Institute of Virginia, Bon Secours Mercy Health, Richmond, VA, USA.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Camargo', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA, USA.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Kersey', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Jia', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA, USA.'}, {'ForeName': 'Yanni', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA, USA.'}, {'ForeName': 'C Stephen', 'Initials': 'CS', 'LastName': 'Djedjos', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA, USA.'}, {'ForeName': 'G Mani', 'Initials': 'GM', 'LastName': 'Subramanian', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA, USA.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Myers', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA, USA.'}, {'ForeName': 'Nadege', 'Initials': 'N', 'LastName': 'Gunn', 'Affiliation': 'Pinnacle Clinical Research, Austin, TX, USA.'}, {'ForeName': 'Aasim', 'Initials': 'A', 'LastName': 'Sheikh', 'Affiliation': 'GI Specialists of Georgia, Marietta, GA, USA.'}, {'ForeName': 'Quentin M', 'Initials': 'QM', 'LastName': 'Anstee', 'Affiliation': 'Institute of Cellular Medicine, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK & Newcastle NIHR Biomedical Research Center, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Romero-Gomez', 'Affiliation': 'Hospital Universitario Virgen del Rocio, Sevilla, Spain.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Trauner', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of Vienna, Austria.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Goodman', 'Affiliation': 'Inova Fairfax Hospital, Falls Church, VA, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lawitz', 'Affiliation': 'Texas Liver Institute, University of Texas Health San Antonio, TX, USA.'}, {'ForeName': 'Zobair', 'Initials': 'Z', 'LastName': 'Younossi', 'Affiliation': 'Inova Fairfax Hospital, Falls Church, VA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of hepatology,['10.1016/j.jhep.2020.02.027']
432,32054731,Pharmacodynamic Analysis of BTK Inhibition in Patients with Chronic Lymphocytic Leukemia Treated with Acalabrutinib.,"PURPOSE


To determine the pharmacodynamic relationship between target occupancy of Bruton tyrosine kinase (BTK) and inhibition of downstream signaling.
PATIENTS AND METHODS


Patients with chronic lymphocytic leukemia (CLL) enrolled in a phase II clinical trial (NCT02337829) with the covalent, selective BTK inhibitor acalabrutinib donated blood samples for pharmacodynamic analyses. Study design included randomization to acalabrutinib 100 mg twice daily or 200 mg once daily and dose interruptions on day 4 and 5 of the first week. BTK occupancy and readouts of intracellular signaling were assessed sequentially between 4 and 48 hours from last dose.
RESULTS


Four hours from last dose, BTK occupancy exceeded 96% and at trough, was higher with twice daily, median 95.3%, than with once daily dosing, median 87.6% ( P  < 0.0001). By 48 hours from last dose, median free BTK increased to 25.6%. Due to covalent binding of acalabrutinib, free BTK is generated by  de novo  synthesis. The estimated rate of BTK synthesis varied widely between patients ranging from 3.6% to 31.4% per day. Acalabrutinib reduced phosphorylation of BTK and inhibited downstream B-cell receptor (BCR) and NFκB signaling. During dosing interruptions up to 48 hours, expression of BCR target genes rebounded, while phosphorylation of signaling molecules remained repressed.  In vitro  cross-linking of IgM on CLL cells obtained 36 to 48 hours from last dose upregulated CD69, with high correlation between cellular free BTK and response ( R  = 0.7,  P  ≤ 0.0001).
CONCLUSIONS


Higher BTK occupancy was achieved with twice daily over once daily dosing, resulting in deeper and more sustained inhibition of BCR signaling.",2020,Acalabrutinib reduced phosphorylation of BTK and inhibited downstream BCR and NF-κB signaling.,"['Patients with Chronic Lymphocytic Leukemia (CLL) enrolled on a phase 2 clinical trial (NCT02337829) with the covalent, selective BTK inhibitor acalabrutinib donated blood samples for pharmacodynamic analyses', 'patients with chronic lymphocytic leukemia treated with acalabrutinib']",[],"['CLL cells', 'BTK occupancy and readouts of intracellular signaling', 'phosphorylation of BTK and inhibited downstream BCR and NF-κB signaling', 'BTK occupancy', 'median free BTK', 'estimated rate of BTK synthesis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C1096779', 'cui_str': 'Clinical Trial, Phase 2'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C4078312', 'cui_str': 'acalabrutinib'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]",[],"[{'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0178719', 'cui_str': 'Intracellular (qualifier value)'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C0522506', 'cui_str': 'Downstream (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]",,0.0559815,Acalabrutinib reduced phosphorylation of BTK and inhibited downstream BCR and NF-κB signaling.,"[{'ForeName': 'Anfal', 'Initials': 'A', 'LastName': 'Alsadhan', 'Affiliation': 'Hematology Branch, National Heart, Lung, and Blood Institute, NIH, Bethesda, Maryland.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Cheung', 'Affiliation': 'Acerta Pharma, South San Francisco, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gulrajani', 'Affiliation': 'Acerta Pharma, South San Francisco, California.'}, {'ForeName': 'Erika M', 'Initials': 'EM', 'LastName': 'Gaglione', 'Affiliation': 'Hematology Branch, National Heart, Lung, and Blood Institute, NIH, Bethesda, Maryland.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Nierman', 'Affiliation': 'Hematology Branch, National Heart, Lung, and Blood Institute, NIH, Bethesda, Maryland.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hamdy', 'Affiliation': 'Acerta Pharma, South San Francisco, California.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Izumi', 'Affiliation': 'Acerta Pharma, South San Francisco, California.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Bibikova', 'Affiliation': 'Acerta Pharma, South San Francisco, California.'}, {'ForeName': 'Priti', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Acerta Pharma, South San Francisco, California.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': 'Hematology Branch, National Heart, Lung, and Blood Institute, NIH, Bethesda, Maryland.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Covey', 'Affiliation': 'Acerta Pharma, South San Francisco, California.'}, {'ForeName': 'Sarah E M', 'Initials': 'SEM', 'LastName': 'Herman', 'Affiliation': 'Hematology Branch, National Heart, Lung, and Blood Institute, NIH, Bethesda, Maryland.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Wiestner', 'Affiliation': 'Hematology Branch, National Heart, Lung, and Blood Institute, NIH, Bethesda, Maryland. wiestnea@nhlbi.nih.gov.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-3505']
433,32184121,Cetuximab and Radiation Therapy Versus Cisplatin and Radiation Therapy for Locally Advanced Head and Neck Cancer: Long-Term Survival and Toxicity Outcomes of a Randomized Phase 2 Trial.,"PURPOSE


This study describes the long-term survival and toxicity outcomes of a multicenter randomized phase 2 trial comparing radiation therapy (RT) plus cisplatin (CDDP) or cetuximab (CTX) as first line treatment in locally advanced head and neck cancer (LASCCHN).
METHODS AND MATERIALS


Between January 2011 and August 2014, 70 patients were enrolled and randomized to receive RT plus weekly CDDP (40 mg/m 2 ) or CTX (250 mg/m 2  plus a loading dose of 400 mg/m 2 ). This updated series focuses on late toxicities (graded by using Common Terminology Criteria for Adverse Events version 4.0) and long-term survival outcomes in terms of local control, overall survival, cancer-specific survival, and metastasis-free survival (MFS). A supplementary analysis based on human papilloma virus (HPV) status was also performed.
RESULTS


No statistically significant difference was found in terms of late effects (xerostomia, fibrosis, mucosal atrophy, weight loss). In the CDDP arm and the CTX arm, 5-year local control rates were 67% and 48%; 5-year MFS rates were 83% and 97%; 5-year overall survival rates were 61% and 52%; and 5-year cancer-specific survival rates were 70% and 59%, respectively. None of these differences reached statistical significance. A subgroup analysis by HPV status and anatomic subsites revealed that in HPV+ oropharyngeal carcinoma, better survival was obtained in the CDDP arm (although statistical tests were not performed owing to the small sample size). Conversely, no statistically significant differences were observed in HPV- oropharyngeal carcinoma and other anatomic subsites, except for the confirmed better MFS rates of the CTX arm.
CONCLUSIONS


Long-term results are in line with current literature suggesting that RT + CTX is inferior to RT + CDDP for the definitive treatment of LASCCHN. However, if not as an alternative to CDDP, CTX might still play a role in LASCCHN, particularly in HPV- cases.",2020,"no statistically significant difference was found in terms of late effects (xerostomia, fibrosis, mucosal atrophy, weight loss).","['ADVANCED HEAD AND NECK CANCER', 'Between January 2011 and August 2014, 70 patients', 'locally advanced head and neck cancer (LASCCHN']","['RT + CTX', 'radiotherapy (RT) plus cisplatin (CDDP) or cetuximab (CTX', 'CTX', 'RT plus weekly CDDP']","['5-year LC rates', 'late effects (xerostomia, fibrosis, mucosal atrophy, weight loss', '5-year CSS rates', 'HPV- OPC', '5-years OS rates', 'local control (LC), overall survival (OS), cancer-specific survival (CSS) and metastasis free survival (MFS', '5-year MFS rates', 'late toxicities', 'MFS rates', 'HPV+ oropharyngeal carcinoma (OPC) better survival']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1368999', 'cui_str': 'Late effect of'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C2242595', 'cui_str': 'Mucosal atrophy'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C0007097', 'cui_str': 'Epithelioma'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}]",70.0,0.184636,"no statistically significant difference was found in terms of late effects (xerostomia, fibrosis, mucosal atrophy, weight loss).","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Maddalo', 'Affiliation': 'Radiation Oncology Department, ASST Spedali Civili di Brescia - Brescia University, Brescia, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Borghetti', 'Affiliation': 'Radiation Oncology Department, ASST Spedali Civili di Brescia - Brescia University, Brescia, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Tomasini', 'Affiliation': 'Radiation Oncology Department, ASST Spedali Civili di Brescia - Brescia University, Brescia, Italy. Electronic address: tomad88@libero.it.'}, {'ForeName': 'Renzo', 'Initials': 'R', 'LastName': 'Corvò', 'Affiliation': 'Health Science Department (DISSAL) University of Genova, Genova - Radiation Oncology Department IRCCS San Martino Hospital, Genova, Italy.'}, {'ForeName': 'Pierluigi', 'Initials': 'P', 'LastName': 'Bonomo', 'Affiliation': 'Department of Radiation Oncology, Azienda Ospedaliero Universitaria Careggi, University of Florence, Florence, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Petrucci', 'Affiliation': 'Pistoia Hospital, Azienda Unità Sanitaria Locale No. 3, Pistoia, Italy.'}, {'ForeName': 'Fabiola', 'Initials': 'F', 'LastName': 'Paiar', 'Affiliation': 'Department of Radiation Oncology, Azienda Ospedaliera Universitaria Pisana, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Lastrucci', 'Affiliation': 'S. Donato Hospital, Azienda Unità Sanitaria Locale No. 8, Arezzo, Italy.'}, {'ForeName': 'Marco Lorenzo', 'Initials': 'ML', 'LastName': 'Bonù', 'Affiliation': 'Radiation Oncology Department, ASST Spedali Civili di Brescia - Brescia University, Brescia, Italy.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Greco', 'Affiliation': 'Radiation Oncology Department, ASST Spedali Civili di Brescia - Brescia University, Brescia, Italy.'}, {'ForeName': 'Loredana', 'Initials': 'L', 'LastName': 'Costa', 'Affiliation': 'Radiation Oncology Department, ASST Spedali Civili di Brescia - Brescia University, Brescia, Italy.'}, {'ForeName': 'Ludovica', 'Initials': 'L', 'LastName': 'Pegurri', 'Affiliation': 'Radiation Oncology Department, ASST Spedali Civili di Brescia - Brescia University, Brescia, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Triggiani', 'Affiliation': 'Radiation Oncology Department, ASST Spedali Civili di Brescia - Brescia University, Brescia, Italy.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Belgioia', 'Affiliation': 'Health Science Department (DISSAL) University of Genova, Genova - Radiation Oncology Department IRCCS San Martino Hospital, Genova, Italy.'}, {'ForeName': 'Isacco', 'Initials': 'I', 'LastName': 'Desideri', 'Affiliation': 'Department of Radiation Oncology, Azienda Ospedaliero Universitaria Careggi, University of Florence, Florence, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Grisanti', 'Affiliation': 'Medical Oncology ASST-Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Buglione', 'Affiliation': 'Radiation Oncology Department, ASST Spedali Civili di Brescia - Brescia University, Brescia, Italy.'}, {'ForeName': 'Stefano Maria', 'Initials': 'SM', 'LastName': 'Magrini', 'Affiliation': 'Radiation Oncology Department, ASST Spedali Civili di Brescia - Brescia University, Brescia, Italy.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.02.637']
434,29356607,"Effects of Aerobic and Resistance Exercise on Metabolic Syndrome, Sarcopenic Obesity, and Circulating Biomarkers in Overweight or Obese Survivors of Breast Cancer: A Randomized Controlled Trial.","Purpose Metabolic syndrome is associated with an increased risk of cardiovascular disease, type 2 diabetes, and breast cancer recurrence in survivors of breast cancer. This randomized controlled trial assessed the effects of a 16-week combined aerobic and resistance exercise intervention on metabolic syndrome, sarcopenic obesity, and serum biomarkers among ethnically diverse, sedentary, overweight, or obese survivors of breast cancer. Methods Eligible survivors of breast cancer (N = 100) were randomly assigned to exercise (n = 50) or usual care (n = 50). The exercise group participated in supervised moderate-to-vigorous-65% to 85% of heart rate maximum-aerobic and resistance exercise three times per week for 16 weeks. Metabolic syndrome z-score (primary outcome), sarcopenic obesity, and serum biomarkers were measured at baseline, postintervention (4 months), and 3-month follow-up (exercise only). Results Participants were age 53 ± 10.4 years, 46% were obese, and 74% were ethnic minorities. Adherence to the intervention was 95%, and postintervention assessments were available in 91% of participants. Postintervention metabolic syndrome z-score was significantly improved in exercise versus usual care (between-group difference, -4.4; 95% CI, -5.9 to -2.7; P < .001). Sarcopenic obesity (appendicular skeletal mass index, P = .001; body mass index, P = .001) and circulating biomarkers, including insulin ( P = .002), IGF-1 ( P = .001), leptin ( P = .001), and adiponectin ( P = .001), were significantly improved postintervention compared with usual care. At 3-month follow-up, all metabolic syndrome variables remained significantly improved compared with baseline in the exercise group ( P < .01). Conclusion Combined resistance and aerobic exercise effectively attenuated metabolic syndrome, sarcopenic obesity, and relevant biomarkers in an ethnically diverse sample of sedentary, overweight, or obese survivors of breast cancer. Our findings suggest a targeted exercise prescription for improving metabolic syndrome in survivors of breast cancer and support the incorporation of supervised clinical exercise programs into breast cancer treatment and survivorship care plans.",2018,"Postintervention metabolic syndrome z-score was significantly improved in exercise versus usual care (between-group difference, -4.4; 95% CI, -5.9 to -2.7; P < .001).","['Results Participants were age 53 ± 10.4 years, 46% were obese, and 74% were ethnic minorities', 'Overweight or Obese Survivors of Breast Cancer', 'survivors of breast cancer', 'Methods Eligible survivors of breast cancer (N = 100', 'ethnically diverse, sedentary, overweight, or obese survivors of breast cancer']","['combined aerobic and resistance exercise intervention', 'exercise group participated in supervised moderate-to-vigorous-65% to 85% of heart rate maximum-aerobic and resistance exercise', 'exercise (n = 50) or usual care', 'targeted exercise prescription', 'Aerobic and Resistance Exercise', 'resistance and aerobic exercise']","['Metabolic syndrome z-score (primary outcome), sarcopenic obesity, and serum biomarkers', 'metabolic syndrome variables', 'Metabolic Syndrome, Sarcopenic Obesity', 'Sarcopenic obesity (appendicular skeletal mass index', 'metabolic syndrome, sarcopenic obesity, and serum biomarkers', 'adiponectin', 'circulating biomarkers, including insulin', 'IGF-1', 'metabolic syndrome, sarcopenic obesity', 'Postintervention metabolic syndrome z-score']","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}]","[{'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}]",100.0,0.0497091,"Postintervention metabolic syndrome z-score was significantly improved in exercise versus usual care (between-group difference, -4.4; 95% CI, -5.9 to -2.7; P < .001).","[{'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Dieli-Conwright', 'Affiliation': 'Christina M. Dieli-Conwright, Nathalie Sami, Kyuwan Lee, Thomas A. Buchanan, and Darcy V. Spicer, University of Southern California, Los Angeles; Leslie Bernstein and Joanne E. Mortimer, City of Hope, Duarte, CA; Kerry S. Courneya, University of Alberta, Edmonton, Alberta, Canada; Wendy Demark-Wahnefried, University of Alabama at Birmingham, Birmingham, AL; and Debu Tripathy, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Kerry S', 'Initials': 'KS', 'LastName': 'Courneya', 'Affiliation': 'Christina M. Dieli-Conwright, Nathalie Sami, Kyuwan Lee, Thomas A. Buchanan, and Darcy V. Spicer, University of Southern California, Los Angeles; Leslie Bernstein and Joanne E. Mortimer, City of Hope, Duarte, CA; Kerry S. Courneya, University of Alberta, Edmonton, Alberta, Canada; Wendy Demark-Wahnefried, University of Alabama at Birmingham, Birmingham, AL; and Debu Tripathy, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Demark-Wahnefried', 'Affiliation': 'Christina M. Dieli-Conwright, Nathalie Sami, Kyuwan Lee, Thomas A. Buchanan, and Darcy V. Spicer, University of Southern California, Los Angeles; Leslie Bernstein and Joanne E. Mortimer, City of Hope, Duarte, CA; Kerry S. Courneya, University of Alberta, Edmonton, Alberta, Canada; Wendy Demark-Wahnefried, University of Alabama at Birmingham, Birmingham, AL; and Debu Tripathy, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Sami', 'Affiliation': 'Christina M. Dieli-Conwright, Nathalie Sami, Kyuwan Lee, Thomas A. Buchanan, and Darcy V. Spicer, University of Southern California, Los Angeles; Leslie Bernstein and Joanne E. Mortimer, City of Hope, Duarte, CA; Kerry S. Courneya, University of Alberta, Edmonton, Alberta, Canada; Wendy Demark-Wahnefried, University of Alabama at Birmingham, Birmingham, AL; and Debu Tripathy, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Kyuwan', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Christina M. Dieli-Conwright, Nathalie Sami, Kyuwan Lee, Thomas A. Buchanan, and Darcy V. Spicer, University of Southern California, Los Angeles; Leslie Bernstein and Joanne E. Mortimer, City of Hope, Duarte, CA; Kerry S. Courneya, University of Alberta, Edmonton, Alberta, Canada; Wendy Demark-Wahnefried, University of Alabama at Birmingham, Birmingham, AL; and Debu Tripathy, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Buchanan', 'Affiliation': 'Christina M. Dieli-Conwright, Nathalie Sami, Kyuwan Lee, Thomas A. Buchanan, and Darcy V. Spicer, University of Southern California, Los Angeles; Leslie Bernstein and Joanne E. Mortimer, City of Hope, Duarte, CA; Kerry S. Courneya, University of Alberta, Edmonton, Alberta, Canada; Wendy Demark-Wahnefried, University of Alabama at Birmingham, Birmingham, AL; and Debu Tripathy, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Darcy V', 'Initials': 'DV', 'LastName': 'Spicer', 'Affiliation': 'Christina M. Dieli-Conwright, Nathalie Sami, Kyuwan Lee, Thomas A. Buchanan, and Darcy V. Spicer, University of Southern California, Los Angeles; Leslie Bernstein and Joanne E. Mortimer, City of Hope, Duarte, CA; Kerry S. Courneya, University of Alberta, Edmonton, Alberta, Canada; Wendy Demark-Wahnefried, University of Alabama at Birmingham, Birmingham, AL; and Debu Tripathy, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Debu', 'Initials': 'D', 'LastName': 'Tripathy', 'Affiliation': 'Christina M. Dieli-Conwright, Nathalie Sami, Kyuwan Lee, Thomas A. Buchanan, and Darcy V. Spicer, University of Southern California, Los Angeles; Leslie Bernstein and Joanne E. Mortimer, City of Hope, Duarte, CA; Kerry S. Courneya, University of Alberta, Edmonton, Alberta, Canada; Wendy Demark-Wahnefried, University of Alabama at Birmingham, Birmingham, AL; and Debu Tripathy, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Bernstein', 'Affiliation': 'Christina M. Dieli-Conwright, Nathalie Sami, Kyuwan Lee, Thomas A. Buchanan, and Darcy V. Spicer, University of Southern California, Los Angeles; Leslie Bernstein and Joanne E. Mortimer, City of Hope, Duarte, CA; Kerry S. Courneya, University of Alberta, Edmonton, Alberta, Canada; Wendy Demark-Wahnefried, University of Alabama at Birmingham, Birmingham, AL; and Debu Tripathy, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Joanne E', 'Initials': 'JE', 'LastName': 'Mortimer', 'Affiliation': 'Christina M. Dieli-Conwright, Nathalie Sami, Kyuwan Lee, Thomas A. Buchanan, and Darcy V. Spicer, University of Southern California, Los Angeles; Leslie Bernstein and Joanne E. Mortimer, City of Hope, Duarte, CA; Kerry S. Courneya, University of Alberta, Edmonton, Alberta, Canada; Wendy Demark-Wahnefried, University of Alabama at Birmingham, Birmingham, AL; and Debu Tripathy, The University of Texas MD Anderson Cancer Center, Houston, TX.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.2017.75.7526']
435,31825569,"Tucatinib, Trastuzumab, and Capecitabine for HER2-Positive Metastatic Breast Cancer.","BACKGROUND


Patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer who have disease progression after therapy with multiple HER2-targeted agents have limited treatment options. Tucatinib is an investigational, oral, highly selective inhibitor of the HER2 tyrosine kinase.
METHODS


We randomly assigned patients with HER2-positive metastatic breast cancer previously treated with trastuzumab, pertuzumab, and trastuzumab emtansine, who had or did not have brain metastases, to receive either tucatinib or placebo, in combination with trastuzumab and capecitabine. The primary end point was progression-free survival among the first 480 patients who underwent randomization. Secondary end points, assessed in the total population (612 patients), included overall survival, progression-free survival among patients with brain metastases, confirmed objective response rate, and safety.
RESULTS


Progression-free survival at 1 year was 33.1% in the tucatinib-combination group and 12.3% in the placebo-combination group (hazard ratio for disease progression or death, 0.54; 95% confidence interval [CI], 0.42 to 0.71; P<0.001), and the median duration of progression-free survival was 7.8 months and 5.6 months, respectively. Overall survival at 2 years was 44.9% in the tucatinib-combination group and 26.6% in the placebo-combination group (hazard ratio for death, 0.66; 95% CI, 0.50 to 0.88; P = 0.005), and the median overall survival was 21.9 months and 17.4 months, respectively. Among the patients with brain metastases, progression-free survival at 1 year was 24.9% in the tucatinib-combination group and 0% in the placebo-combination group (hazard ratio, 0.48; 95% CI, 0.34 to 0.69; P<0.001), and the median progression-free survival was 7.6 months and 5.4 months, respectively. Common adverse events in the tucatinib group included diarrhea, palmar-plantar erythrodysesthesia syndrome, nausea, fatigue, and vomiting. Diarrhea and elevated aminotransferase levels of grade 3 or higher were more common in the tucatinib-combination group than in the placebo-combination group.
CONCLUSIONS


In heavily pretreated patients with HER2-positive metastatic breast cancer, including those with brain metastases, adding tucatinib to trastuzumab and capecitabine resulted in better progression-free survival and overall survival outcomes than adding placebo; the risks of diarrhea and elevated aminotransferase levels were higher with tucatinib. (Funded by Seattle Genetics; HER2CLIMB ClinicalTrials.gov number, NCT02614794.).",2020,"RESULTS


Progression-free survival at 1 year was 33.1% in the tucatinib-combination group and 12.3% in the placebo-combination group (hazard ratio for disease progression or death, 0.54;","['Patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer who have disease progression after therapy with multiple HER2-targeted agents', 'HER2-Positive Metastatic Breast Cancer', 'We randomly assigned patients with HER2-positive metastatic breast cancer previously treated with', 'heavily pretreated patients with HER2-positive metastatic breast cancer']","['trastuzumab and capecitabine', 'trastuzumab, pertuzumab, and trastuzumab emtansine, who had or did not have brain metastases, to receive either tucatinib or placebo, in combination with trastuzumab and capecitabine', 'placebo', 'Tucatinib, Trastuzumab, and Capecitabine']","['overall survival, progression-free survival', 'median progression-free survival', 'Progression-free survival', 'progression-free survival and overall survival outcomes', 'median overall survival', 'progression-free survival', 'Diarrhea and elevated aminotransferase levels', 'objective response rate, and safety', 'risks of diarrhea and elevated aminotransferase levels', 'diarrhea, palmar-plantar erythrodysesthesia syndrome, nausea, fatigue, and vomiting', 'Overall survival', 'median duration of progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C4721209', 'cui_str': 'Metastasis from human epidermal growth factor 2 positive carcinoma of breast'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C2935436', 'cui_str': 'ado-trastuzumab emtansine'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain (disorder)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0549410', 'cui_str': 'Chemotherapy-Induced Palmoplantar Erythrodysesthesia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",612.0,0.420447,"RESULTS


Progression-free survival at 1 year was 33.1% in the tucatinib-combination group and 12.3% in the placebo-combination group (hazard ratio for disease progression or death, 0.54;","[{'ForeName': 'Rashmi K', 'Initials': 'RK', 'LastName': 'Murthy', 'Affiliation': ""From M.D. Anderson Cancer Center, Houston (R.K.M., G.H.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S. Loi); the Royal Marsden NHS Foundation Trust, London (A.O.), and Edinburgh Cancer Research Centre, Edinburgh (D.C.) - both in the United Kingdom; Winship Cancer Institute, Atlanta (E.P.); Sarah Cannon Research Institute/Tennessee Oncology-Nashville (E.H.) and Vanderbilt University Medical Center (V.A.), Nashville; University of California, Los Angeles, Medical Center-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H., D.S.), and Stanford Comprehensive Cancer Institute, Palo Alto (M.P.) - both in California; Dana-Farber Cancer Institute, Boston (N.U.L., I.K., E.P.W.); University of Colorado Cancer Center, Aurora (V.B.); Duke Cancer Institute, Durham (C.A.), and University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill (L.A.C.) - both in North Carolina; University Health Network, Princess Margaret Cancer Centre, Toronto (P.L.B.), and British Columbia Cancer, Vancouver (K.G.) - both in Canada; Hospital Universitario Vall D'Hebron, Barcelona (M.O.); Sygehus Lillebaelt-Vejle Sygehus, Vejle, Denmark (E.J.); Centre Léon Bérard, Lyon, France (T.B.); Rambam Health Care Campus, Haifa, Israel (S.S.S.); Universitaetsklinikum Hamburg-Eppendorf, Hamburg (V.M.), and German Breast Group, Neu-Isenburg (S. Loibl) - both in Germany; Hospital Cuf Descobertas R. Mário Botas, Lisbon, Portugal (S.B.); Cliniques Universitaires Saint-Luc, Brussels (F.P.D.); Third Medical Department, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); Istituto Europeo di Oncologia, IRCCS, University of Milan, Milan (G.C.); and Seattle Genetics, Bothell, WA (M.C.P.-W., L.W., W.F.).""}, {'ForeName': 'Sherene', 'Initials': 'S', 'LastName': 'Loi', 'Affiliation': ""From M.D. Anderson Cancer Center, Houston (R.K.M., G.H.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S. Loi); the Royal Marsden NHS Foundation Trust, London (A.O.), and Edinburgh Cancer Research Centre, Edinburgh (D.C.) - both in the United Kingdom; Winship Cancer Institute, Atlanta (E.P.); Sarah Cannon Research Institute/Tennessee Oncology-Nashville (E.H.) and Vanderbilt University Medical Center (V.A.), Nashville; University of California, Los Angeles, Medical Center-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H., D.S.), and Stanford Comprehensive Cancer Institute, Palo Alto (M.P.) - both in California; Dana-Farber Cancer Institute, Boston (N.U.L., I.K., E.P.W.); University of Colorado Cancer Center, Aurora (V.B.); Duke Cancer Institute, Durham (C.A.), and University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill (L.A.C.) - both in North Carolina; University Health Network, Princess Margaret Cancer Centre, Toronto (P.L.B.), and British Columbia Cancer, Vancouver (K.G.) - both in Canada; Hospital Universitario Vall D'Hebron, Barcelona (M.O.); Sygehus Lillebaelt-Vejle Sygehus, Vejle, Denmark (E.J.); Centre Léon Bérard, Lyon, France (T.B.); Rambam Health Care Campus, Haifa, Israel (S.S.S.); Universitaetsklinikum Hamburg-Eppendorf, Hamburg (V.M.), and German Breast Group, Neu-Isenburg (S. Loibl) - both in Germany; Hospital Cuf Descobertas R. Mário Botas, Lisbon, Portugal (S.B.); Cliniques Universitaires Saint-Luc, Brussels (F.P.D.); Third Medical Department, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); Istituto Europeo di Oncologia, IRCCS, University of Milan, Milan (G.C.); and Seattle Genetics, Bothell, WA (M.C.P.-W., L.W., W.F.).""}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Okines', 'Affiliation': ""From M.D. Anderson Cancer Center, Houston (R.K.M., G.H.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S. Loi); the Royal Marsden NHS Foundation Trust, London (A.O.), and Edinburgh Cancer Research Centre, Edinburgh (D.C.) - both in the United Kingdom; Winship Cancer Institute, Atlanta (E.P.); Sarah Cannon Research Institute/Tennessee Oncology-Nashville (E.H.) and Vanderbilt University Medical Center (V.A.), Nashville; University of California, Los Angeles, Medical Center-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H., D.S.), and Stanford Comprehensive Cancer Institute, Palo Alto (M.P.) - both in California; Dana-Farber Cancer Institute, Boston (N.U.L., I.K., E.P.W.); University of Colorado Cancer Center, Aurora (V.B.); Duke Cancer Institute, Durham (C.A.), and University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill (L.A.C.) - both in North Carolina; University Health Network, Princess Margaret Cancer Centre, Toronto (P.L.B.), and British Columbia Cancer, Vancouver (K.G.) - both in Canada; Hospital Universitario Vall D'Hebron, Barcelona (M.O.); Sygehus Lillebaelt-Vejle Sygehus, Vejle, Denmark (E.J.); Centre Léon Bérard, Lyon, France (T.B.); Rambam Health Care Campus, Haifa, Israel (S.S.S.); Universitaetsklinikum Hamburg-Eppendorf, Hamburg (V.M.), and German Breast Group, Neu-Isenburg (S. Loibl) - both in Germany; Hospital Cuf Descobertas R. Mário Botas, Lisbon, Portugal (S.B.); Cliniques Universitaires Saint-Luc, Brussels (F.P.D.); Third Medical Department, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); Istituto Europeo di Oncologia, IRCCS, University of Milan, Milan (G.C.); and Seattle Genetics, Bothell, WA (M.C.P.-W., L.W., W.F.).""}, {'ForeName': 'Elisavet', 'Initials': 'E', 'LastName': 'Paplomata', 'Affiliation': ""From M.D. Anderson Cancer Center, Houston (R.K.M., G.H.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S. Loi); the Royal Marsden NHS Foundation Trust, London (A.O.), and Edinburgh Cancer Research Centre, Edinburgh (D.C.) - both in the United Kingdom; Winship Cancer Institute, Atlanta (E.P.); Sarah Cannon Research Institute/Tennessee Oncology-Nashville (E.H.) and Vanderbilt University Medical Center (V.A.), Nashville; University of California, Los Angeles, Medical Center-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H., D.S.), and Stanford Comprehensive Cancer Institute, Palo Alto (M.P.) - both in California; Dana-Farber Cancer Institute, Boston (N.U.L., I.K., E.P.W.); University of Colorado Cancer Center, Aurora (V.B.); Duke Cancer Institute, Durham (C.A.), and University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill (L.A.C.) - both in North Carolina; University Health Network, Princess Margaret Cancer Centre, Toronto (P.L.B.), and British Columbia Cancer, Vancouver (K.G.) - both in Canada; Hospital Universitario Vall D'Hebron, Barcelona (M.O.); Sygehus Lillebaelt-Vejle Sygehus, Vejle, Denmark (E.J.); Centre Léon Bérard, Lyon, France (T.B.); Rambam Health Care Campus, Haifa, Israel (S.S.S.); Universitaetsklinikum Hamburg-Eppendorf, Hamburg (V.M.), and German Breast Group, Neu-Isenburg (S. Loibl) - both in Germany; Hospital Cuf Descobertas R. Mário Botas, Lisbon, Portugal (S.B.); Cliniques Universitaires Saint-Luc, Brussels (F.P.D.); Third Medical Department, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); Istituto Europeo di Oncologia, IRCCS, University of Milan, Milan (G.C.); and Seattle Genetics, Bothell, WA (M.C.P.-W., L.W., W.F.).""}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Hamilton', 'Affiliation': ""From M.D. Anderson Cancer Center, Houston (R.K.M., G.H.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S. Loi); the Royal Marsden NHS Foundation Trust, London (A.O.), and Edinburgh Cancer Research Centre, Edinburgh (D.C.) - both in the United Kingdom; Winship Cancer Institute, Atlanta (E.P.); Sarah Cannon Research Institute/Tennessee Oncology-Nashville (E.H.) and Vanderbilt University Medical Center (V.A.), Nashville; University of California, Los Angeles, Medical Center-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H., D.S.), and Stanford Comprehensive Cancer Institute, Palo Alto (M.P.) - both in California; Dana-Farber Cancer Institute, Boston (N.U.L., I.K., E.P.W.); University of Colorado Cancer Center, Aurora (V.B.); Duke Cancer Institute, Durham (C.A.), and University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill (L.A.C.) - both in North Carolina; University Health Network, Princess Margaret Cancer Centre, Toronto (P.L.B.), and British Columbia Cancer, Vancouver (K.G.) - both in Canada; Hospital Universitario Vall D'Hebron, Barcelona (M.O.); Sygehus Lillebaelt-Vejle Sygehus, Vejle, Denmark (E.J.); Centre Léon Bérard, Lyon, France (T.B.); Rambam Health Care Campus, Haifa, Israel (S.S.S.); Universitaetsklinikum Hamburg-Eppendorf, Hamburg (V.M.), and German Breast Group, Neu-Isenburg (S. Loibl) - both in Germany; Hospital Cuf Descobertas R. Mário Botas, Lisbon, Portugal (S.B.); Cliniques Universitaires Saint-Luc, Brussels (F.P.D.); Third Medical Department, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); Istituto Europeo di Oncologia, IRCCS, University of Milan, Milan (G.C.); and Seattle Genetics, Bothell, WA (M.C.P.-W., L.W., W.F.).""}, {'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Hurvitz', 'Affiliation': ""From M.D. Anderson Cancer Center, Houston (R.K.M., G.H.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S. Loi); the Royal Marsden NHS Foundation Trust, London (A.O.), and Edinburgh Cancer Research Centre, Edinburgh (D.C.) - both in the United Kingdom; Winship Cancer Institute, Atlanta (E.P.); Sarah Cannon Research Institute/Tennessee Oncology-Nashville (E.H.) and Vanderbilt University Medical Center (V.A.), Nashville; University of California, Los Angeles, Medical Center-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H., D.S.), and Stanford Comprehensive Cancer Institute, Palo Alto (M.P.) - both in California; Dana-Farber Cancer Institute, Boston (N.U.L., I.K., E.P.W.); University of Colorado Cancer Center, Aurora (V.B.); Duke Cancer Institute, Durham (C.A.), and University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill (L.A.C.) - both in North Carolina; University Health Network, Princess Margaret Cancer Centre, Toronto (P.L.B.), and British Columbia Cancer, Vancouver (K.G.) - both in Canada; Hospital Universitario Vall D'Hebron, Barcelona (M.O.); Sygehus Lillebaelt-Vejle Sygehus, Vejle, Denmark (E.J.); Centre Léon Bérard, Lyon, France (T.B.); Rambam Health Care Campus, Haifa, Israel (S.S.S.); Universitaetsklinikum Hamburg-Eppendorf, Hamburg (V.M.), and German Breast Group, Neu-Isenburg (S. Loibl) - both in Germany; Hospital Cuf Descobertas R. Mário Botas, Lisbon, Portugal (S.B.); Cliniques Universitaires Saint-Luc, Brussels (F.P.D.); Third Medical Department, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); Istituto Europeo di Oncologia, IRCCS, University of Milan, Milan (G.C.); and Seattle Genetics, Bothell, WA (M.C.P.-W., L.W., W.F.).""}, {'ForeName': 'Nancy U', 'Initials': 'NU', 'LastName': 'Lin', 'Affiliation': ""From M.D. Anderson Cancer Center, Houston (R.K.M., G.H.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S. Loi); the Royal Marsden NHS Foundation Trust, London (A.O.), and Edinburgh Cancer Research Centre, Edinburgh (D.C.) - both in the United Kingdom; Winship Cancer Institute, Atlanta (E.P.); Sarah Cannon Research Institute/Tennessee Oncology-Nashville (E.H.) and Vanderbilt University Medical Center (V.A.), Nashville; University of California, Los Angeles, Medical Center-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H., D.S.), and Stanford Comprehensive Cancer Institute, Palo Alto (M.P.) - both in California; Dana-Farber Cancer Institute, Boston (N.U.L., I.K., E.P.W.); University of Colorado Cancer Center, Aurora (V.B.); Duke Cancer Institute, Durham (C.A.), and University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill (L.A.C.) - both in North Carolina; University Health Network, Princess Margaret Cancer Centre, Toronto (P.L.B.), and British Columbia Cancer, Vancouver (K.G.) - both in Canada; Hospital Universitario Vall D'Hebron, Barcelona (M.O.); Sygehus Lillebaelt-Vejle Sygehus, Vejle, Denmark (E.J.); Centre Léon Bérard, Lyon, France (T.B.); Rambam Health Care Campus, Haifa, Israel (S.S.S.); Universitaetsklinikum Hamburg-Eppendorf, Hamburg (V.M.), and German Breast Group, Neu-Isenburg (S. Loibl) - both in Germany; Hospital Cuf Descobertas R. Mário Botas, Lisbon, Portugal (S.B.); Cliniques Universitaires Saint-Luc, Brussels (F.P.D.); Third Medical Department, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); Istituto Europeo di Oncologia, IRCCS, University of Milan, Milan (G.C.); and Seattle Genetics, Bothell, WA (M.C.P.-W., L.W., W.F.).""}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Borges', 'Affiliation': ""From M.D. Anderson Cancer Center, Houston (R.K.M., G.H.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S. Loi); the Royal Marsden NHS Foundation Trust, London (A.O.), and Edinburgh Cancer Research Centre, Edinburgh (D.C.) - both in the United Kingdom; Winship Cancer Institute, Atlanta (E.P.); Sarah Cannon Research Institute/Tennessee Oncology-Nashville (E.H.) and Vanderbilt University Medical Center (V.A.), Nashville; University of California, Los Angeles, Medical Center-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H., D.S.), and Stanford Comprehensive Cancer Institute, Palo Alto (M.P.) - both in California; Dana-Farber Cancer Institute, Boston (N.U.L., I.K., E.P.W.); University of Colorado Cancer Center, Aurora (V.B.); Duke Cancer Institute, Durham (C.A.), and University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill (L.A.C.) - both in North Carolina; University Health Network, Princess Margaret Cancer Centre, Toronto (P.L.B.), and British Columbia Cancer, Vancouver (K.G.) - both in Canada; Hospital Universitario Vall D'Hebron, Barcelona (M.O.); Sygehus Lillebaelt-Vejle Sygehus, Vejle, Denmark (E.J.); Centre Léon Bérard, Lyon, France (T.B.); Rambam Health Care Campus, Haifa, Israel (S.S.S.); Universitaetsklinikum Hamburg-Eppendorf, Hamburg (V.M.), and German Breast Group, Neu-Isenburg (S. Loibl) - both in Germany; Hospital Cuf Descobertas R. Mário Botas, Lisbon, Portugal (S.B.); Cliniques Universitaires Saint-Luc, Brussels (F.P.D.); Third Medical Department, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); Istituto Europeo di Oncologia, IRCCS, University of Milan, Milan (G.C.); and Seattle Genetics, Bothell, WA (M.C.P.-W., L.W., W.F.).""}, {'ForeName': 'Vandana', 'Initials': 'V', 'LastName': 'Abramson', 'Affiliation': ""From M.D. Anderson Cancer Center, Houston (R.K.M., G.H.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S. Loi); the Royal Marsden NHS Foundation Trust, London (A.O.), and Edinburgh Cancer Research Centre, Edinburgh (D.C.) - both in the United Kingdom; Winship Cancer Institute, Atlanta (E.P.); Sarah Cannon Research Institute/Tennessee Oncology-Nashville (E.H.) and Vanderbilt University Medical Center (V.A.), Nashville; University of California, Los Angeles, Medical Center-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H., D.S.), and Stanford Comprehensive Cancer Institute, Palo Alto (M.P.) - both in California; Dana-Farber Cancer Institute, Boston (N.U.L., I.K., E.P.W.); University of Colorado Cancer Center, Aurora (V.B.); Duke Cancer Institute, Durham (C.A.), and University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill (L.A.C.) - both in North Carolina; University Health Network, Princess Margaret Cancer Centre, Toronto (P.L.B.), and British Columbia Cancer, Vancouver (K.G.) - both in Canada; Hospital Universitario Vall D'Hebron, Barcelona (M.O.); Sygehus Lillebaelt-Vejle Sygehus, Vejle, Denmark (E.J.); Centre Léon Bérard, Lyon, France (T.B.); Rambam Health Care Campus, Haifa, Israel (S.S.S.); Universitaetsklinikum Hamburg-Eppendorf, Hamburg (V.M.), and German Breast Group, Neu-Isenburg (S. Loibl) - both in Germany; Hospital Cuf Descobertas R. Mário Botas, Lisbon, Portugal (S.B.); Cliniques Universitaires Saint-Luc, Brussels (F.P.D.); Third Medical Department, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); Istituto Europeo di Oncologia, IRCCS, University of Milan, Milan (G.C.); and Seattle Genetics, Bothell, WA (M.C.P.-W., L.W., W.F.).""}, {'ForeName': 'Carey', 'Initials': 'C', 'LastName': 'Anders', 'Affiliation': ""From M.D. Anderson Cancer Center, Houston (R.K.M., G.H.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S. Loi); the Royal Marsden NHS Foundation Trust, London (A.O.), and Edinburgh Cancer Research Centre, Edinburgh (D.C.) - both in the United Kingdom; Winship Cancer Institute, Atlanta (E.P.); Sarah Cannon Research Institute/Tennessee Oncology-Nashville (E.H.) and Vanderbilt University Medical Center (V.A.), Nashville; University of California, Los Angeles, Medical Center-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H., D.S.), and Stanford Comprehensive Cancer Institute, Palo Alto (M.P.) - both in California; Dana-Farber Cancer Institute, Boston (N.U.L., I.K., E.P.W.); University of Colorado Cancer Center, Aurora (V.B.); Duke Cancer Institute, Durham (C.A.), and University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill (L.A.C.) - both in North Carolina; University Health Network, Princess Margaret Cancer Centre, Toronto (P.L.B.), and British Columbia Cancer, Vancouver (K.G.) - both in Canada; Hospital Universitario Vall D'Hebron, Barcelona (M.O.); Sygehus Lillebaelt-Vejle Sygehus, Vejle, Denmark (E.J.); Centre Léon Bérard, Lyon, France (T.B.); Rambam Health Care Campus, Haifa, Israel (S.S.S.); Universitaetsklinikum Hamburg-Eppendorf, Hamburg (V.M.), and German Breast Group, Neu-Isenburg (S. Loibl) - both in Germany; Hospital Cuf Descobertas R. Mário Botas, Lisbon, Portugal (S.B.); Cliniques Universitaires Saint-Luc, Brussels (F.P.D.); Third Medical Department, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); Istituto Europeo di Oncologia, IRCCS, University of Milan, Milan (G.C.); and Seattle Genetics, Bothell, WA (M.C.P.-W., L.W., W.F.).""}, {'ForeName': 'Philippe L', 'Initials': 'PL', 'LastName': 'Bedard', 'Affiliation': ""From M.D. Anderson Cancer Center, Houston (R.K.M., G.H.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S. Loi); the Royal Marsden NHS Foundation Trust, London (A.O.), and Edinburgh Cancer Research Centre, Edinburgh (D.C.) - both in the United Kingdom; Winship Cancer Institute, Atlanta (E.P.); Sarah Cannon Research Institute/Tennessee Oncology-Nashville (E.H.) and Vanderbilt University Medical Center (V.A.), Nashville; University of California, Los Angeles, Medical Center-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H., D.S.), and Stanford Comprehensive Cancer Institute, Palo Alto (M.P.) - both in California; Dana-Farber Cancer Institute, Boston (N.U.L., I.K., E.P.W.); University of Colorado Cancer Center, Aurora (V.B.); Duke Cancer Institute, Durham (C.A.), and University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill (L.A.C.) - both in North Carolina; University Health Network, Princess Margaret Cancer Centre, Toronto (P.L.B.), and British Columbia Cancer, Vancouver (K.G.) - both in Canada; Hospital Universitario Vall D'Hebron, Barcelona (M.O.); Sygehus Lillebaelt-Vejle Sygehus, Vejle, Denmark (E.J.); Centre Léon Bérard, Lyon, France (T.B.); Rambam Health Care Campus, Haifa, Israel (S.S.S.); Universitaetsklinikum Hamburg-Eppendorf, Hamburg (V.M.), and German Breast Group, Neu-Isenburg (S. Loibl) - both in Germany; Hospital Cuf Descobertas R. Mário Botas, Lisbon, Portugal (S.B.); Cliniques Universitaires Saint-Luc, Brussels (F.P.D.); Third Medical Department, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); Istituto Europeo di Oncologia, IRCCS, University of Milan, Milan (G.C.); and Seattle Genetics, Bothell, WA (M.C.P.-W., L.W., W.F.).""}, {'ForeName': 'Mafalda', 'Initials': 'M', 'LastName': 'Oliveira', 'Affiliation': ""From M.D. Anderson Cancer Center, Houston (R.K.M., G.H.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S. Loi); the Royal Marsden NHS Foundation Trust, London (A.O.), and Edinburgh Cancer Research Centre, Edinburgh (D.C.) - both in the United Kingdom; Winship Cancer Institute, Atlanta (E.P.); Sarah Cannon Research Institute/Tennessee Oncology-Nashville (E.H.) and Vanderbilt University Medical Center (V.A.), Nashville; University of California, Los Angeles, Medical Center-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H., D.S.), and Stanford Comprehensive Cancer Institute, Palo Alto (M.P.) - both in California; Dana-Farber Cancer Institute, Boston (N.U.L., I.K., E.P.W.); University of Colorado Cancer Center, Aurora (V.B.); Duke Cancer Institute, Durham (C.A.), and University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill (L.A.C.) - both in North Carolina; University Health Network, Princess Margaret Cancer Centre, Toronto (P.L.B.), and British Columbia Cancer, Vancouver (K.G.) - both in Canada; Hospital Universitario Vall D'Hebron, Barcelona (M.O.); Sygehus Lillebaelt-Vejle Sygehus, Vejle, Denmark (E.J.); Centre Léon Bérard, Lyon, France (T.B.); Rambam Health Care Campus, Haifa, Israel (S.S.S.); Universitaetsklinikum Hamburg-Eppendorf, Hamburg (V.M.), and German Breast Group, Neu-Isenburg (S. Loibl) - both in Germany; Hospital Cuf Descobertas R. Mário Botas, Lisbon, Portugal (S.B.); Cliniques Universitaires Saint-Luc, Brussels (F.P.D.); Third Medical Department, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); Istituto Europeo di Oncologia, IRCCS, University of Milan, Milan (G.C.); and Seattle Genetics, Bothell, WA (M.C.P.-W., L.W., W.F.).""}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Jakobsen', 'Affiliation': ""From M.D. Anderson Cancer Center, Houston (R.K.M., G.H.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S. Loi); the Royal Marsden NHS Foundation Trust, London (A.O.), and Edinburgh Cancer Research Centre, Edinburgh (D.C.) - both in the United Kingdom; Winship Cancer Institute, Atlanta (E.P.); Sarah Cannon Research Institute/Tennessee Oncology-Nashville (E.H.) and Vanderbilt University Medical Center (V.A.), Nashville; University of California, Los Angeles, Medical Center-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H., D.S.), and Stanford Comprehensive Cancer Institute, Palo Alto (M.P.) - both in California; Dana-Farber Cancer Institute, Boston (N.U.L., I.K., E.P.W.); University of Colorado Cancer Center, Aurora (V.B.); Duke Cancer Institute, Durham (C.A.), and University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill (L.A.C.) - both in North Carolina; University Health Network, Princess Margaret Cancer Centre, Toronto (P.L.B.), and British Columbia Cancer, Vancouver (K.G.) - both in Canada; Hospital Universitario Vall D'Hebron, Barcelona (M.O.); Sygehus Lillebaelt-Vejle Sygehus, Vejle, Denmark (E.J.); Centre Léon Bérard, Lyon, France (T.B.); Rambam Health Care Campus, Haifa, Israel (S.S.S.); Universitaetsklinikum Hamburg-Eppendorf, Hamburg (V.M.), and German Breast Group, Neu-Isenburg (S. Loibl) - both in Germany; Hospital Cuf Descobertas R. Mário Botas, Lisbon, Portugal (S.B.); Cliniques Universitaires Saint-Luc, Brussels (F.P.D.); Third Medical Department, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); Istituto Europeo di Oncologia, IRCCS, University of Milan, Milan (G.C.); and Seattle Genetics, Bothell, WA (M.C.P.-W., L.W., W.F.).""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bachelot', 'Affiliation': ""From M.D. Anderson Cancer Center, Houston (R.K.M., G.H.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S. Loi); the Royal Marsden NHS Foundation Trust, London (A.O.), and Edinburgh Cancer Research Centre, Edinburgh (D.C.) - both in the United Kingdom; Winship Cancer Institute, Atlanta (E.P.); Sarah Cannon Research Institute/Tennessee Oncology-Nashville (E.H.) and Vanderbilt University Medical Center (V.A.), Nashville; University of California, Los Angeles, Medical Center-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H., D.S.), and Stanford Comprehensive Cancer Institute, Palo Alto (M.P.) - both in California; Dana-Farber Cancer Institute, Boston (N.U.L., I.K., E.P.W.); University of Colorado Cancer Center, Aurora (V.B.); Duke Cancer Institute, Durham (C.A.), and University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill (L.A.C.) - both in North Carolina; University Health Network, Princess Margaret Cancer Centre, Toronto (P.L.B.), and British Columbia Cancer, Vancouver (K.G.) - both in Canada; Hospital Universitario Vall D'Hebron, Barcelona (M.O.); Sygehus Lillebaelt-Vejle Sygehus, Vejle, Denmark (E.J.); Centre Léon Bérard, Lyon, France (T.B.); Rambam Health Care Campus, Haifa, Israel (S.S.S.); Universitaetsklinikum Hamburg-Eppendorf, Hamburg (V.M.), and German Breast Group, Neu-Isenburg (S. Loibl) - both in Germany; Hospital Cuf Descobertas R. Mário Botas, Lisbon, Portugal (S.B.); Cliniques Universitaires Saint-Luc, Brussels (F.P.D.); Third Medical Department, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); Istituto Europeo di Oncologia, IRCCS, University of Milan, Milan (G.C.); and Seattle Genetics, Bothell, WA (M.C.P.-W., L.W., W.F.).""}, {'ForeName': 'Shlomit S', 'Initials': 'SS', 'LastName': 'Shachar', 'Affiliation': ""From M.D. Anderson Cancer Center, Houston (R.K.M., G.H.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S. Loi); the Royal Marsden NHS Foundation Trust, London (A.O.), and Edinburgh Cancer Research Centre, Edinburgh (D.C.) - both in the United Kingdom; Winship Cancer Institute, Atlanta (E.P.); Sarah Cannon Research Institute/Tennessee Oncology-Nashville (E.H.) and Vanderbilt University Medical Center (V.A.), Nashville; University of California, Los Angeles, Medical Center-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H., D.S.), and Stanford Comprehensive Cancer Institute, Palo Alto (M.P.) - both in California; Dana-Farber Cancer Institute, Boston (N.U.L., I.K., E.P.W.); University of Colorado Cancer Center, Aurora (V.B.); Duke Cancer Institute, Durham (C.A.), and University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill (L.A.C.) - both in North Carolina; University Health Network, Princess Margaret Cancer Centre, Toronto (P.L.B.), and British Columbia Cancer, Vancouver (K.G.) - both in Canada; Hospital Universitario Vall D'Hebron, Barcelona (M.O.); Sygehus Lillebaelt-Vejle Sygehus, Vejle, Denmark (E.J.); Centre Léon Bérard, Lyon, France (T.B.); Rambam Health Care Campus, Haifa, Israel (S.S.S.); Universitaetsklinikum Hamburg-Eppendorf, Hamburg (V.M.), and German Breast Group, Neu-Isenburg (S. Loibl) - both in Germany; Hospital Cuf Descobertas R. Mário Botas, Lisbon, Portugal (S.B.); Cliniques Universitaires Saint-Luc, Brussels (F.P.D.); Third Medical Department, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); Istituto Europeo di Oncologia, IRCCS, University of Milan, Milan (G.C.); and Seattle Genetics, Bothell, WA (M.C.P.-W., L.W., W.F.).""}, {'ForeName': 'Volkmar', 'Initials': 'V', 'LastName': 'Müller', 'Affiliation': ""From M.D. Anderson Cancer Center, Houston (R.K.M., G.H.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S. Loi); the Royal Marsden NHS Foundation Trust, London (A.O.), and Edinburgh Cancer Research Centre, Edinburgh (D.C.) - both in the United Kingdom; Winship Cancer Institute, Atlanta (E.P.); Sarah Cannon Research Institute/Tennessee Oncology-Nashville (E.H.) and Vanderbilt University Medical Center (V.A.), Nashville; University of California, Los Angeles, Medical Center-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H., D.S.), and Stanford Comprehensive Cancer Institute, Palo Alto (M.P.) - both in California; Dana-Farber Cancer Institute, Boston (N.U.L., I.K., E.P.W.); University of Colorado Cancer Center, Aurora (V.B.); Duke Cancer Institute, Durham (C.A.), and University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill (L.A.C.) - both in North Carolina; University Health Network, Princess Margaret Cancer Centre, Toronto (P.L.B.), and British Columbia Cancer, Vancouver (K.G.) - both in Canada; Hospital Universitario Vall D'Hebron, Barcelona (M.O.); Sygehus Lillebaelt-Vejle Sygehus, Vejle, Denmark (E.J.); Centre Léon Bérard, Lyon, France (T.B.); Rambam Health Care Campus, Haifa, Israel (S.S.S.); Universitaetsklinikum Hamburg-Eppendorf, Hamburg (V.M.), and German Breast Group, Neu-Isenburg (S. Loibl) - both in Germany; Hospital Cuf Descobertas R. Mário Botas, Lisbon, Portugal (S.B.); Cliniques Universitaires Saint-Luc, Brussels (F.P.D.); Third Medical Department, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); Istituto Europeo di Oncologia, IRCCS, University of Milan, Milan (G.C.); and Seattle Genetics, Bothell, WA (M.C.P.-W., L.W., W.F.).""}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Braga', 'Affiliation': ""From M.D. Anderson Cancer Center, Houston (R.K.M., G.H.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S. Loi); the Royal Marsden NHS Foundation Trust, London (A.O.), and Edinburgh Cancer Research Centre, Edinburgh (D.C.) - both in the United Kingdom; Winship Cancer Institute, Atlanta (E.P.); Sarah Cannon Research Institute/Tennessee Oncology-Nashville (E.H.) and Vanderbilt University Medical Center (V.A.), Nashville; University of California, Los Angeles, Medical Center-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H., D.S.), and Stanford Comprehensive Cancer Institute, Palo Alto (M.P.) - both in California; Dana-Farber Cancer Institute, Boston (N.U.L., I.K., E.P.W.); University of Colorado Cancer Center, Aurora (V.B.); Duke Cancer Institute, Durham (C.A.), and University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill (L.A.C.) - both in North Carolina; University Health Network, Princess Margaret Cancer Centre, Toronto (P.L.B.), and British Columbia Cancer, Vancouver (K.G.) - both in Canada; Hospital Universitario Vall D'Hebron, Barcelona (M.O.); Sygehus Lillebaelt-Vejle Sygehus, Vejle, Denmark (E.J.); Centre Léon Bérard, Lyon, France (T.B.); Rambam Health Care Campus, Haifa, Israel (S.S.S.); Universitaetsklinikum Hamburg-Eppendorf, Hamburg (V.M.), and German Breast Group, Neu-Isenburg (S. Loibl) - both in Germany; Hospital Cuf Descobertas R. Mário Botas, Lisbon, Portugal (S.B.); Cliniques Universitaires Saint-Luc, Brussels (F.P.D.); Third Medical Department, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); Istituto Europeo di Oncologia, IRCCS, University of Milan, Milan (G.C.); and Seattle Genetics, Bothell, WA (M.C.P.-W., L.W., W.F.).""}, {'ForeName': 'Francois P', 'Initials': 'FP', 'LastName': 'Duhoux', 'Affiliation': ""From M.D. Anderson Cancer Center, Houston (R.K.M., G.H.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S. Loi); the Royal Marsden NHS Foundation Trust, London (A.O.), and Edinburgh Cancer Research Centre, Edinburgh (D.C.) - both in the United Kingdom; Winship Cancer Institute, Atlanta (E.P.); Sarah Cannon Research Institute/Tennessee Oncology-Nashville (E.H.) and Vanderbilt University Medical Center (V.A.), Nashville; University of California, Los Angeles, Medical Center-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H., D.S.), and Stanford Comprehensive Cancer Institute, Palo Alto (M.P.) - both in California; Dana-Farber Cancer Institute, Boston (N.U.L., I.K., E.P.W.); University of Colorado Cancer Center, Aurora (V.B.); Duke Cancer Institute, Durham (C.A.), and University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill (L.A.C.) - both in North Carolina; University Health Network, Princess Margaret Cancer Centre, Toronto (P.L.B.), and British Columbia Cancer, Vancouver (K.G.) - both in Canada; Hospital Universitario Vall D'Hebron, Barcelona (M.O.); Sygehus Lillebaelt-Vejle Sygehus, Vejle, Denmark (E.J.); Centre Léon Bérard, Lyon, France (T.B.); Rambam Health Care Campus, Haifa, Israel (S.S.S.); Universitaetsklinikum Hamburg-Eppendorf, Hamburg (V.M.), and German Breast Group, Neu-Isenburg (S. Loibl) - both in Germany; Hospital Cuf Descobertas R. Mário Botas, Lisbon, Portugal (S.B.); Cliniques Universitaires Saint-Luc, Brussels (F.P.D.); Third Medical Department, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); Istituto Europeo di Oncologia, IRCCS, University of Milan, Milan (G.C.); and Seattle Genetics, Bothell, WA (M.C.P.-W., L.W., W.F.).""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': ""From M.D. Anderson Cancer Center, Houston (R.K.M., G.H.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S. Loi); the Royal Marsden NHS Foundation Trust, London (A.O.), and Edinburgh Cancer Research Centre, Edinburgh (D.C.) - both in the United Kingdom; Winship Cancer Institute, Atlanta (E.P.); Sarah Cannon Research Institute/Tennessee Oncology-Nashville (E.H.) and Vanderbilt University Medical Center (V.A.), Nashville; University of California, Los Angeles, Medical Center-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H., D.S.), and Stanford Comprehensive Cancer Institute, Palo Alto (M.P.) - both in California; Dana-Farber Cancer Institute, Boston (N.U.L., I.K., E.P.W.); University of Colorado Cancer Center, Aurora (V.B.); Duke Cancer Institute, Durham (C.A.), and University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill (L.A.C.) - both in North Carolina; University Health Network, Princess Margaret Cancer Centre, Toronto (P.L.B.), and British Columbia Cancer, Vancouver (K.G.) - both in Canada; Hospital Universitario Vall D'Hebron, Barcelona (M.O.); Sygehus Lillebaelt-Vejle Sygehus, Vejle, Denmark (E.J.); Centre Léon Bérard, Lyon, France (T.B.); Rambam Health Care Campus, Haifa, Israel (S.S.S.); Universitaetsklinikum Hamburg-Eppendorf, Hamburg (V.M.), and German Breast Group, Neu-Isenburg (S. Loibl) - both in Germany; Hospital Cuf Descobertas R. Mário Botas, Lisbon, Portugal (S.B.); Cliniques Universitaires Saint-Luc, Brussels (F.P.D.); Third Medical Department, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); Istituto Europeo di Oncologia, IRCCS, University of Milan, Milan (G.C.); and Seattle Genetics, Bothell, WA (M.C.P.-W., L.W., W.F.).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cameron', 'Affiliation': ""From M.D. Anderson Cancer Center, Houston (R.K.M., G.H.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S. Loi); the Royal Marsden NHS Foundation Trust, London (A.O.), and Edinburgh Cancer Research Centre, Edinburgh (D.C.) - both in the United Kingdom; Winship Cancer Institute, Atlanta (E.P.); Sarah Cannon Research Institute/Tennessee Oncology-Nashville (E.H.) and Vanderbilt University Medical Center (V.A.), Nashville; University of California, Los Angeles, Medical Center-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H., D.S.), and Stanford Comprehensive Cancer Institute, Palo Alto (M.P.) - both in California; Dana-Farber Cancer Institute, Boston (N.U.L., I.K., E.P.W.); University of Colorado Cancer Center, Aurora (V.B.); Duke Cancer Institute, Durham (C.A.), and University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill (L.A.C.) - both in North Carolina; University Health Network, Princess Margaret Cancer Centre, Toronto (P.L.B.), and British Columbia Cancer, Vancouver (K.G.) - both in Canada; Hospital Universitario Vall D'Hebron, Barcelona (M.O.); Sygehus Lillebaelt-Vejle Sygehus, Vejle, Denmark (E.J.); Centre Léon Bérard, Lyon, France (T.B.); Rambam Health Care Campus, Haifa, Israel (S.S.S.); Universitaetsklinikum Hamburg-Eppendorf, Hamburg (V.M.), and German Breast Group, Neu-Isenburg (S. Loibl) - both in Germany; Hospital Cuf Descobertas R. Mário Botas, Lisbon, Portugal (S.B.); Cliniques Universitaires Saint-Luc, Brussels (F.P.D.); Third Medical Department, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); Istituto Europeo di Oncologia, IRCCS, University of Milan, Milan (G.C.); and Seattle Genetics, Bothell, WA (M.C.P.-W., L.W., W.F.).""}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Carey', 'Affiliation': ""From M.D. Anderson Cancer Center, Houston (R.K.M., G.H.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S. Loi); the Royal Marsden NHS Foundation Trust, London (A.O.), and Edinburgh Cancer Research Centre, Edinburgh (D.C.) - both in the United Kingdom; Winship Cancer Institute, Atlanta (E.P.); Sarah Cannon Research Institute/Tennessee Oncology-Nashville (E.H.) and Vanderbilt University Medical Center (V.A.), Nashville; University of California, Los Angeles, Medical Center-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H., D.S.), and Stanford Comprehensive Cancer Institute, Palo Alto (M.P.) - both in California; Dana-Farber Cancer Institute, Boston (N.U.L., I.K., E.P.W.); University of Colorado Cancer Center, Aurora (V.B.); Duke Cancer Institute, Durham (C.A.), and University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill (L.A.C.) - both in North Carolina; University Health Network, Princess Margaret Cancer Centre, Toronto (P.L.B.), and British Columbia Cancer, Vancouver (K.G.) - both in Canada; Hospital Universitario Vall D'Hebron, Barcelona (M.O.); Sygehus Lillebaelt-Vejle Sygehus, Vejle, Denmark (E.J.); Centre Léon Bérard, Lyon, France (T.B.); Rambam Health Care Campus, Haifa, Israel (S.S.S.); Universitaetsklinikum Hamburg-Eppendorf, Hamburg (V.M.), and German Breast Group, Neu-Isenburg (S. Loibl) - both in Germany; Hospital Cuf Descobertas R. Mário Botas, Lisbon, Portugal (S.B.); Cliniques Universitaires Saint-Luc, Brussels (F.P.D.); Third Medical Department, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); Istituto Europeo di Oncologia, IRCCS, University of Milan, Milan (G.C.); and Seattle Genetics, Bothell, WA (M.C.P.-W., L.W., W.F.).""}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Curigliano', 'Affiliation': ""From M.D. Anderson Cancer Center, Houston (R.K.M., G.H.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S. Loi); the Royal Marsden NHS Foundation Trust, London (A.O.), and Edinburgh Cancer Research Centre, Edinburgh (D.C.) - both in the United Kingdom; Winship Cancer Institute, Atlanta (E.P.); Sarah Cannon Research Institute/Tennessee Oncology-Nashville (E.H.) and Vanderbilt University Medical Center (V.A.), Nashville; University of California, Los Angeles, Medical Center-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H., D.S.), and Stanford Comprehensive Cancer Institute, Palo Alto (M.P.) - both in California; Dana-Farber Cancer Institute, Boston (N.U.L., I.K., E.P.W.); University of Colorado Cancer Center, Aurora (V.B.); Duke Cancer Institute, Durham (C.A.), and University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill (L.A.C.) - both in North Carolina; University Health Network, Princess Margaret Cancer Centre, Toronto (P.L.B.), and British Columbia Cancer, Vancouver (K.G.) - both in Canada; Hospital Universitario Vall D'Hebron, Barcelona (M.O.); Sygehus Lillebaelt-Vejle Sygehus, Vejle, Denmark (E.J.); Centre Léon Bérard, Lyon, France (T.B.); Rambam Health Care Campus, Haifa, Israel (S.S.S.); Universitaetsklinikum Hamburg-Eppendorf, Hamburg (V.M.), and German Breast Group, Neu-Isenburg (S. Loibl) - both in Germany; Hospital Cuf Descobertas R. Mário Botas, Lisbon, Portugal (S.B.); Cliniques Universitaires Saint-Luc, Brussels (F.P.D.); Third Medical Department, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); Istituto Europeo di Oncologia, IRCCS, University of Milan, Milan (G.C.); and Seattle Genetics, Bothell, WA (M.C.P.-W., L.W., W.F.).""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Gelmon', 'Affiliation': ""From M.D. Anderson Cancer Center, Houston (R.K.M., G.H.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S. Loi); the Royal Marsden NHS Foundation Trust, London (A.O.), and Edinburgh Cancer Research Centre, Edinburgh (D.C.) - both in the United Kingdom; Winship Cancer Institute, Atlanta (E.P.); Sarah Cannon Research Institute/Tennessee Oncology-Nashville (E.H.) and Vanderbilt University Medical Center (V.A.), Nashville; University of California, Los Angeles, Medical Center-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H., D.S.), and Stanford Comprehensive Cancer Institute, Palo Alto (M.P.) - both in California; Dana-Farber Cancer Institute, Boston (N.U.L., I.K., E.P.W.); University of Colorado Cancer Center, Aurora (V.B.); Duke Cancer Institute, Durham (C.A.), and University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill (L.A.C.) - both in North Carolina; University Health Network, Princess Margaret Cancer Centre, Toronto (P.L.B.), and British Columbia Cancer, Vancouver (K.G.) - both in Canada; Hospital Universitario Vall D'Hebron, Barcelona (M.O.); Sygehus Lillebaelt-Vejle Sygehus, Vejle, Denmark (E.J.); Centre Léon Bérard, Lyon, France (T.B.); Rambam Health Care Campus, Haifa, Israel (S.S.S.); Universitaetsklinikum Hamburg-Eppendorf, Hamburg (V.M.), and German Breast Group, Neu-Isenburg (S. Loibl) - both in Germany; Hospital Cuf Descobertas R. Mário Botas, Lisbon, Portugal (S.B.); Cliniques Universitaires Saint-Luc, Brussels (F.P.D.); Third Medical Department, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); Istituto Europeo di Oncologia, IRCCS, University of Milan, Milan (G.C.); and Seattle Genetics, Bothell, WA (M.C.P.-W., L.W., W.F.).""}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Hortobagyi', 'Affiliation': ""From M.D. Anderson Cancer Center, Houston (R.K.M., G.H.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S. Loi); the Royal Marsden NHS Foundation Trust, London (A.O.), and Edinburgh Cancer Research Centre, Edinburgh (D.C.) - both in the United Kingdom; Winship Cancer Institute, Atlanta (E.P.); Sarah Cannon Research Institute/Tennessee Oncology-Nashville (E.H.) and Vanderbilt University Medical Center (V.A.), Nashville; University of California, Los Angeles, Medical Center-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H., D.S.), and Stanford Comprehensive Cancer Institute, Palo Alto (M.P.) - both in California; Dana-Farber Cancer Institute, Boston (N.U.L., I.K., E.P.W.); University of Colorado Cancer Center, Aurora (V.B.); Duke Cancer Institute, Durham (C.A.), and University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill (L.A.C.) - both in North Carolina; University Health Network, Princess Margaret Cancer Centre, Toronto (P.L.B.), and British Columbia Cancer, Vancouver (K.G.) - both in Canada; Hospital Universitario Vall D'Hebron, Barcelona (M.O.); Sygehus Lillebaelt-Vejle Sygehus, Vejle, Denmark (E.J.); Centre Léon Bérard, Lyon, France (T.B.); Rambam Health Care Campus, Haifa, Israel (S.S.S.); Universitaetsklinikum Hamburg-Eppendorf, Hamburg (V.M.), and German Breast Group, Neu-Isenburg (S. Loibl) - both in Germany; Hospital Cuf Descobertas R. Mário Botas, Lisbon, Portugal (S.B.); Cliniques Universitaires Saint-Luc, Brussels (F.P.D.); Third Medical Department, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); Istituto Europeo di Oncologia, IRCCS, University of Milan, Milan (G.C.); and Seattle Genetics, Bothell, WA (M.C.P.-W., L.W., W.F.).""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Krop', 'Affiliation': ""From M.D. Anderson Cancer Center, Houston (R.K.M., G.H.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S. Loi); the Royal Marsden NHS Foundation Trust, London (A.O.), and Edinburgh Cancer Research Centre, Edinburgh (D.C.) - both in the United Kingdom; Winship Cancer Institute, Atlanta (E.P.); Sarah Cannon Research Institute/Tennessee Oncology-Nashville (E.H.) and Vanderbilt University Medical Center (V.A.), Nashville; University of California, Los Angeles, Medical Center-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H., D.S.), and Stanford Comprehensive Cancer Institute, Palo Alto (M.P.) - both in California; Dana-Farber Cancer Institute, Boston (N.U.L., I.K., E.P.W.); University of Colorado Cancer Center, Aurora (V.B.); Duke Cancer Institute, Durham (C.A.), and University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill (L.A.C.) - both in North Carolina; University Health Network, Princess Margaret Cancer Centre, Toronto (P.L.B.), and British Columbia Cancer, Vancouver (K.G.) - both in Canada; Hospital Universitario Vall D'Hebron, Barcelona (M.O.); Sygehus Lillebaelt-Vejle Sygehus, Vejle, Denmark (E.J.); Centre Léon Bérard, Lyon, France (T.B.); Rambam Health Care Campus, Haifa, Israel (S.S.S.); Universitaetsklinikum Hamburg-Eppendorf, Hamburg (V.M.), and German Breast Group, Neu-Isenburg (S. Loibl) - both in Germany; Hospital Cuf Descobertas R. Mário Botas, Lisbon, Portugal (S.B.); Cliniques Universitaires Saint-Luc, Brussels (F.P.D.); Third Medical Department, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); Istituto Europeo di Oncologia, IRCCS, University of Milan, Milan (G.C.); and Seattle Genetics, Bothell, WA (M.C.P.-W., L.W., W.F.).""}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': ""From M.D. Anderson Cancer Center, Houston (R.K.M., G.H.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S. Loi); the Royal Marsden NHS Foundation Trust, London (A.O.), and Edinburgh Cancer Research Centre, Edinburgh (D.C.) - both in the United Kingdom; Winship Cancer Institute, Atlanta (E.P.); Sarah Cannon Research Institute/Tennessee Oncology-Nashville (E.H.) and Vanderbilt University Medical Center (V.A.), Nashville; University of California, Los Angeles, Medical Center-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H., D.S.), and Stanford Comprehensive Cancer Institute, Palo Alto (M.P.) - both in California; Dana-Farber Cancer Institute, Boston (N.U.L., I.K., E.P.W.); University of Colorado Cancer Center, Aurora (V.B.); Duke Cancer Institute, Durham (C.A.), and University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill (L.A.C.) - both in North Carolina; University Health Network, Princess Margaret Cancer Centre, Toronto (P.L.B.), and British Columbia Cancer, Vancouver (K.G.) - both in Canada; Hospital Universitario Vall D'Hebron, Barcelona (M.O.); Sygehus Lillebaelt-Vejle Sygehus, Vejle, Denmark (E.J.); Centre Léon Bérard, Lyon, France (T.B.); Rambam Health Care Campus, Haifa, Israel (S.S.S.); Universitaetsklinikum Hamburg-Eppendorf, Hamburg (V.M.), and German Breast Group, Neu-Isenburg (S. Loibl) - both in Germany; Hospital Cuf Descobertas R. Mário Botas, Lisbon, Portugal (S.B.); Cliniques Universitaires Saint-Luc, Brussels (F.P.D.); Third Medical Department, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); Istituto Europeo di Oncologia, IRCCS, University of Milan, Milan (G.C.); and Seattle Genetics, Bothell, WA (M.C.P.-W., L.W., W.F.).""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Pegram', 'Affiliation': ""From M.D. Anderson Cancer Center, Houston (R.K.M., G.H.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S. Loi); the Royal Marsden NHS Foundation Trust, London (A.O.), and Edinburgh Cancer Research Centre, Edinburgh (D.C.) - both in the United Kingdom; Winship Cancer Institute, Atlanta (E.P.); Sarah Cannon Research Institute/Tennessee Oncology-Nashville (E.H.) and Vanderbilt University Medical Center (V.A.), Nashville; University of California, Los Angeles, Medical Center-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H., D.S.), and Stanford Comprehensive Cancer Institute, Palo Alto (M.P.) - both in California; Dana-Farber Cancer Institute, Boston (N.U.L., I.K., E.P.W.); University of Colorado Cancer Center, Aurora (V.B.); Duke Cancer Institute, Durham (C.A.), and University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill (L.A.C.) - both in North Carolina; University Health Network, Princess Margaret Cancer Centre, Toronto (P.L.B.), and British Columbia Cancer, Vancouver (K.G.) - both in Canada; Hospital Universitario Vall D'Hebron, Barcelona (M.O.); Sygehus Lillebaelt-Vejle Sygehus, Vejle, Denmark (E.J.); Centre Léon Bérard, Lyon, France (T.B.); Rambam Health Care Campus, Haifa, Israel (S.S.S.); Universitaetsklinikum Hamburg-Eppendorf, Hamburg (V.M.), and German Breast Group, Neu-Isenburg (S. Loibl) - both in Germany; Hospital Cuf Descobertas R. Mário Botas, Lisbon, Portugal (S.B.); Cliniques Universitaires Saint-Luc, Brussels (F.P.D.); Third Medical Department, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); Istituto Europeo di Oncologia, IRCCS, University of Milan, Milan (G.C.); and Seattle Genetics, Bothell, WA (M.C.P.-W., L.W., W.F.).""}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Slamon', 'Affiliation': ""From M.D. Anderson Cancer Center, Houston (R.K.M., G.H.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S. Loi); the Royal Marsden NHS Foundation Trust, London (A.O.), and Edinburgh Cancer Research Centre, Edinburgh (D.C.) - both in the United Kingdom; Winship Cancer Institute, Atlanta (E.P.); Sarah Cannon Research Institute/Tennessee Oncology-Nashville (E.H.) and Vanderbilt University Medical Center (V.A.), Nashville; University of California, Los Angeles, Medical Center-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H., D.S.), and Stanford Comprehensive Cancer Institute, Palo Alto (M.P.) - both in California; Dana-Farber Cancer Institute, Boston (N.U.L., I.K., E.P.W.); University of Colorado Cancer Center, Aurora (V.B.); Duke Cancer Institute, Durham (C.A.), and University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill (L.A.C.) - both in North Carolina; University Health Network, Princess Margaret Cancer Centre, Toronto (P.L.B.), and British Columbia Cancer, Vancouver (K.G.) - both in Canada; Hospital Universitario Vall D'Hebron, Barcelona (M.O.); Sygehus Lillebaelt-Vejle Sygehus, Vejle, Denmark (E.J.); Centre Léon Bérard, Lyon, France (T.B.); Rambam Health Care Campus, Haifa, Israel (S.S.S.); Universitaetsklinikum Hamburg-Eppendorf, Hamburg (V.M.), and German Breast Group, Neu-Isenburg (S. Loibl) - both in Germany; Hospital Cuf Descobertas R. Mário Botas, Lisbon, Portugal (S.B.); Cliniques Universitaires Saint-Luc, Brussels (F.P.D.); Third Medical Department, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); Istituto Europeo di Oncologia, IRCCS, University of Milan, Milan (G.C.); and Seattle Genetics, Bothell, WA (M.C.P.-W., L.W., W.F.).""}, {'ForeName': 'M Corinna', 'Initials': 'MC', 'LastName': 'Palanca-Wessels', 'Affiliation': ""From M.D. Anderson Cancer Center, Houston (R.K.M., G.H.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S. Loi); the Royal Marsden NHS Foundation Trust, London (A.O.), and Edinburgh Cancer Research Centre, Edinburgh (D.C.) - both in the United Kingdom; Winship Cancer Institute, Atlanta (E.P.); Sarah Cannon Research Institute/Tennessee Oncology-Nashville (E.H.) and Vanderbilt University Medical Center (V.A.), Nashville; University of California, Los Angeles, Medical Center-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H., D.S.), and Stanford Comprehensive Cancer Institute, Palo Alto (M.P.) - both in California; Dana-Farber Cancer Institute, Boston (N.U.L., I.K., E.P.W.); University of Colorado Cancer Center, Aurora (V.B.); Duke Cancer Institute, Durham (C.A.), and University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill (L.A.C.) - both in North Carolina; University Health Network, Princess Margaret Cancer Centre, Toronto (P.L.B.), and British Columbia Cancer, Vancouver (K.G.) - both in Canada; Hospital Universitario Vall D'Hebron, Barcelona (M.O.); Sygehus Lillebaelt-Vejle Sygehus, Vejle, Denmark (E.J.); Centre Léon Bérard, Lyon, France (T.B.); Rambam Health Care Campus, Haifa, Israel (S.S.S.); Universitaetsklinikum Hamburg-Eppendorf, Hamburg (V.M.), and German Breast Group, Neu-Isenburg (S. Loibl) - both in Germany; Hospital Cuf Descobertas R. Mário Botas, Lisbon, Portugal (S.B.); Cliniques Universitaires Saint-Luc, Brussels (F.P.D.); Third Medical Department, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); Istituto Europeo di Oncologia, IRCCS, University of Milan, Milan (G.C.); and Seattle Genetics, Bothell, WA (M.C.P.-W., L.W., W.F.).""}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Walker', 'Affiliation': ""From M.D. Anderson Cancer Center, Houston (R.K.M., G.H.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S. Loi); the Royal Marsden NHS Foundation Trust, London (A.O.), and Edinburgh Cancer Research Centre, Edinburgh (D.C.) - both in the United Kingdom; Winship Cancer Institute, Atlanta (E.P.); Sarah Cannon Research Institute/Tennessee Oncology-Nashville (E.H.) and Vanderbilt University Medical Center (V.A.), Nashville; University of California, Los Angeles, Medical Center-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H., D.S.), and Stanford Comprehensive Cancer Institute, Palo Alto (M.P.) - both in California; Dana-Farber Cancer Institute, Boston (N.U.L., I.K., E.P.W.); University of Colorado Cancer Center, Aurora (V.B.); Duke Cancer Institute, Durham (C.A.), and University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill (L.A.C.) - both in North Carolina; University Health Network, Princess Margaret Cancer Centre, Toronto (P.L.B.), and British Columbia Cancer, Vancouver (K.G.) - both in Canada; Hospital Universitario Vall D'Hebron, Barcelona (M.O.); Sygehus Lillebaelt-Vejle Sygehus, Vejle, Denmark (E.J.); Centre Léon Bérard, Lyon, France (T.B.); Rambam Health Care Campus, Haifa, Israel (S.S.S.); Universitaetsklinikum Hamburg-Eppendorf, Hamburg (V.M.), and German Breast Group, Neu-Isenburg (S. Loibl) - both in Germany; Hospital Cuf Descobertas R. Mário Botas, Lisbon, Portugal (S.B.); Cliniques Universitaires Saint-Luc, Brussels (F.P.D.); Third Medical Department, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); Istituto Europeo di Oncologia, IRCCS, University of Milan, Milan (G.C.); and Seattle Genetics, Bothell, WA (M.C.P.-W., L.W., W.F.).""}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Feng', 'Affiliation': ""From M.D. Anderson Cancer Center, Houston (R.K.M., G.H.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S. Loi); the Royal Marsden NHS Foundation Trust, London (A.O.), and Edinburgh Cancer Research Centre, Edinburgh (D.C.) - both in the United Kingdom; Winship Cancer Institute, Atlanta (E.P.); Sarah Cannon Research Institute/Tennessee Oncology-Nashville (E.H.) and Vanderbilt University Medical Center (V.A.), Nashville; University of California, Los Angeles, Medical Center-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H., D.S.), and Stanford Comprehensive Cancer Institute, Palo Alto (M.P.) - both in California; Dana-Farber Cancer Institute, Boston (N.U.L., I.K., E.P.W.); University of Colorado Cancer Center, Aurora (V.B.); Duke Cancer Institute, Durham (C.A.), and University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill (L.A.C.) - both in North Carolina; University Health Network, Princess Margaret Cancer Centre, Toronto (P.L.B.), and British Columbia Cancer, Vancouver (K.G.) - both in Canada; Hospital Universitario Vall D'Hebron, Barcelona (M.O.); Sygehus Lillebaelt-Vejle Sygehus, Vejle, Denmark (E.J.); Centre Léon Bérard, Lyon, France (T.B.); Rambam Health Care Campus, Haifa, Israel (S.S.S.); Universitaetsklinikum Hamburg-Eppendorf, Hamburg (V.M.), and German Breast Group, Neu-Isenburg (S. Loibl) - both in Germany; Hospital Cuf Descobertas R. Mário Botas, Lisbon, Portugal (S.B.); Cliniques Universitaires Saint-Luc, Brussels (F.P.D.); Third Medical Department, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); Istituto Europeo di Oncologia, IRCCS, University of Milan, Milan (G.C.); and Seattle Genetics, Bothell, WA (M.C.P.-W., L.W., W.F.).""}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Winer', 'Affiliation': ""From M.D. Anderson Cancer Center, Houston (R.K.M., G.H.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S. Loi); the Royal Marsden NHS Foundation Trust, London (A.O.), and Edinburgh Cancer Research Centre, Edinburgh (D.C.) - both in the United Kingdom; Winship Cancer Institute, Atlanta (E.P.); Sarah Cannon Research Institute/Tennessee Oncology-Nashville (E.H.) and Vanderbilt University Medical Center (V.A.), Nashville; University of California, Los Angeles, Medical Center-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H., D.S.), and Stanford Comprehensive Cancer Institute, Palo Alto (M.P.) - both in California; Dana-Farber Cancer Institute, Boston (N.U.L., I.K., E.P.W.); University of Colorado Cancer Center, Aurora (V.B.); Duke Cancer Institute, Durham (C.A.), and University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill (L.A.C.) - both in North Carolina; University Health Network, Princess Margaret Cancer Centre, Toronto (P.L.B.), and British Columbia Cancer, Vancouver (K.G.) - both in Canada; Hospital Universitario Vall D'Hebron, Barcelona (M.O.); Sygehus Lillebaelt-Vejle Sygehus, Vejle, Denmark (E.J.); Centre Léon Bérard, Lyon, France (T.B.); Rambam Health Care Campus, Haifa, Israel (S.S.S.); Universitaetsklinikum Hamburg-Eppendorf, Hamburg (V.M.), and German Breast Group, Neu-Isenburg (S. Loibl) - both in Germany; Hospital Cuf Descobertas R. Mário Botas, Lisbon, Portugal (S.B.); Cliniques Universitaires Saint-Luc, Brussels (F.P.D.); Third Medical Department, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); Istituto Europeo di Oncologia, IRCCS, University of Milan, Milan (G.C.); and Seattle Genetics, Bothell, WA (M.C.P.-W., L.W., W.F.).""}]",The New England journal of medicine,['10.1056/NEJMoa1914609']
436,31629656,"Short-term androgen deprivation therapy combined with radiotherapy as salvage treatment after radical prostatectomy for prostate cancer (GETUG-AFU 16): a 112-month follow-up of a phase 3, randomised trial.","BACKGROUND


Radiotherapy is the standard salvage treatment after radical prostatectomy. To date, the role of androgen deprivation therapy has not been formally shown. In this follow-up study, we aimed to update the results of the GETUG-AFU 16 trial, which assessed the efficacy of radiotherapy plus androgen suppression versus radiotherapy alone.
METHODS


GETUG-AFU 16 was an open-label, multicentre, phase 3, randomised, controlled trial that enrolled men (aged ≥18 years) with Eastern Cooperative Oncology Group performance status of 0 or 1, with histologically confirmed adenocarcinoma of the prostate (but no previous androgen suppression or pelvic radiotherapy), stage pT2, T3, or T4a (bladder neck involvement only) and pN0 or pNx according to the tumour, node, metastasis (TNM) staging system, whose prostate-specific antigen (PSA) concentration increased from 0·1 ng/mL to between 0·2 ng/mL and 2·0 ng/mL after radical prostatectomy, without evidence of clinical disease. Patients were assigned through central randomisation (1:1) to short-term androgen suppression (subcutaneous injection of 10·8 mg goserelin on the first day of irradiation and 3 months later) plus radiotherapy (3D conformal radiotherapy or intensity modulated radiotherapy of 66 Gy in 33 fractions, 5 days a week for 7 weeks) or radiotherapy alone. Randomisation was stratified using a permuted block method (block sizes of two and four) according to investigational site, radiotherapy modality, and prognosis. The primary endpoint was progression-free survival in the intention-to-treat population. This post-hoc one-shot data collection done 4 years after last data cutoff included patients who were alive at the time of the primary analysis and updated long-term patient status by including dates for first local progression, metastatic disease diagnosis, or death (if any of these had occurred) or the date of the last tumour evaluation or last PSA measurement. Survival at 120 months was reported. Late serious adverse effects were assessed. This trial is registered on ClinicalTrials.gov, NCT00423475.
FINDINGS


Between Oct 19, 2006, and March 30, 2010, 743 patients were randomly assigned, 374 to radiotherapy alone and 369 to radiotherapy plus goserelin. At the time of data cutoff (March 12, 2019), the median follow-up was 112 months (IQR 102-123). The 120-month progression-free survival was 64% (95% CI 58-69) for patients treated with radiotherapy plus goserelin and 49% (43-54) for patients treated with radiotherapy alone (hazard ratio 0·54, 0·43-0·68; stratified log-rank test p<0·0001). Two cases of secondary cancer occurred since the primary analysis, but were not considered to be treatment related. No treatment-related deaths occurred.
INTERPRETATION


The 120-month progression-free survival confirmed the results from the primary analysis. Salvage radiotherapy combined with short-term androgen suppression significantly reduced risk of biochemical or clinical progression and death compared with salvage radiotherapy alone. The results of the GETUG-AFU 16 trial confirm the efficacy of androgen suppression plus radiotherapy as salvage treatment in patients with increasing PSA concentration after radical prostatectomy for prostate cancer.
FUNDING


The French Health ministry, AstraZeneca, la Ligue Contre le Cancer, and La Ligue de Haute-Savoie.",2019,Salvage radiotherapy combined with short-term androgen suppression significantly reduced risk of biochemical or clinical progression and death compared with salvage radiotherapy alone.,"['743 patients were randomly assigned, 374 to', 'enrolled men (aged ≥18 years) with Eastern Cooperative Oncology Group performance status of 0 or 1, with histologically confirmed adenocarcinoma of the prostate (but no previous androgen suppression or pelvic radiotherapy), stage pT2, T3, or T4a (bladder neck involvement only) and pN0 or pNx according to the tumour, node, metastasis (TNM) staging system, whose prostate-specific antigen (PSA) concentration increased from 0·1', 'Between Oct 19, 2006, and March 30, 2010', 'patients with increasing PSA concentration after radical prostatectomy for prostate cancer', 'patients who were alive at the time of the primary analysis and updated long-term patient status by including dates for first local progression, metastatic disease diagnosis, or death (if any of these had occurred) or the date of the last tumour evaluation or last PSA measurement']","['radiotherapy alone and 369 to radiotherapy plus goserelin', 'radiotherapy plus goserelin', 'Salvage radiotherapy combined with short-term androgen suppression', 'Short-term androgen deprivation therapy combined with radiotherapy', 'radiotherapy alone', 'Radiotherapy', 'salvage radiotherapy', 'radiotherapy plus androgen suppression versus radiotherapy alone', 'radiotherapy (3D conformal radiotherapy or intensity modulated radiotherapy', 'short-term androgen suppression (subcutaneous injection of 10·8 mg goserelin', 'androgen deprivation therapy', 'androgen suppression plus radiotherapy', 'radiotherapy']","['120-month progression-free survival', 'progression-free survival', 'risk of biochemical or clinical progression and death', 'Late serious adverse effects', 'Survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C4042485', 'cui_str': 'Pt(acac)2'}, {'cui': 'C0227716', 'cui_str': 'Structure of neck of urinary bladder'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0449437', 'cui_str': 'Patient status (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0120107', 'cui_str': 'Goserelin'}, {'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0600521', 'cui_str': 'Three-Dimensional Conformal Radiotherapy'}, {'cui': 'C1512814', 'cui_str': 'Radiotherapy, Intensity-Modulated'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous Injections'}]","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",743.0,0.219457,Salvage radiotherapy combined with short-term androgen suppression significantly reduced risk of biochemical or clinical progression and death compared with salvage radiotherapy alone.,"[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Carrie', 'Affiliation': 'Radiotherapy Department, Léon Bérard Center, Lyon, France; CNRS UMR 5220, INSERM U1044, INSA, University of Lyon, Lyon, France. Electronic address: christian.carrie@lyon.unicancer.fr.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Magné', 'Affiliation': 'Cellular and Molecular Radiobiology, Lucien Neuwirth Cancer Institute, and Institute of Nuclear Physics of Lyon, Lyon-Sud Faculty of Medicine, Lyon, France.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Burban-Provost', 'Affiliation': ""private hospital of Cotes D'armor, Plerin, France.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sargos', 'Affiliation': 'Radiotherapy Department, Bergonié Institute, Bordeaux, France.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Latorzeff', 'Affiliation': 'Clinique Pasteur Groupe Oncorad Garonne, Toulouse, France.'}, {'ForeName': 'Jean-Léon', 'Initials': 'JL', 'LastName': 'Lagrange', 'Affiliation': 'Henri Mondor Breast Center, Créteil, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Supiot', 'Affiliation': 'René Gauducheau cancer Institute, Nantes, France.'}, {'ForeName': 'Yazid', 'Initials': 'Y', 'LastName': 'Belkacemi', 'Affiliation': 'Department of Radiation Oncology and Henri Mondor Breast Center, University of Paris-Est, Créteil, France.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Peiffert', 'Affiliation': 'Lorraine Cancer Institute, Alexis Vautrin Cancer Center, Université de Lorraine, Faculté de Médecine, Vandoeuvre-les-Nancy, France.'}, {'ForeName': 'Nedla', 'Initials': 'N', 'LastName': 'Allouache', 'Affiliation': 'François Baclesse Cancer Center, Caen, France.'}, {'ForeName': 'Bernard M', 'Initials': 'BM', 'LastName': 'Dubray', 'Affiliation': 'Henri Becquerel Cancer Center, Rouen, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Servagi-Vernat', 'Affiliation': 'Jean Godinot Institute, Reims, France.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Suchaud', 'Affiliation': 'Radiotherapy Department, Roanne hospital center, Roanne, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Crehange', 'Affiliation': 'Georges-François Leclerc Cancer Center, Dijon, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Guerif', 'Affiliation': 'University hospital of Poitiers, Poitiers, France.'}, {'ForeName': 'Meryem', 'Initials': 'M', 'LastName': 'Brihoum', 'Affiliation': 'UNICANCER, Paris, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Barbier', 'Affiliation': 'Catalan Cancer Center, Perpignan, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Graff-Cailleaud', 'Affiliation': 'University Institute of Cancer Toulouse-Oncopôle, Toulouse, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Ruffion', 'Affiliation': 'Urology Department, Hospices Civils de Lyon, Pierre-Bénite, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Dussart', 'Affiliation': 'Biostatistics Unit, Clinical Research and Innovation Department, Léon Bérard Cancer Centre, Lyon, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Ferlay', 'Affiliation': 'Biostatistics Unit, Clinical Research and Innovation Department, Léon Bérard Cancer Centre, Lyon, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Chabaud', 'Affiliation': 'Biostatistics Unit, Clinical Research and Innovation Department, Léon Bérard Cancer Centre, Lyon, France.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30486-3']
437,31582408,Metabolite Profiles of Incident Diabetes and Heterogeneity of Treatment Effect in the Diabetes Prevention Program.,"Novel biomarkers of type 2 diabetes (T2D) and response to preventative treatment in individuals with similar clinical risk may highlight metabolic pathways that are important in disease development. We profiled 331 metabolites in 2,015 baseline plasma samples from the Diabetes Prevention Program (DPP). Cox models were used to determine associations between metabolites and incident T2D, as well as whether associations differed by treatment group (i.e., lifestyle [ILS], metformin [MET], or placebo [PLA]), over an average of 3.2 years of follow-up. We found 69 metabolites associated with incident T2D regardless of treatment randomization. In particular, cytosine was novel and associated with the lowest risk. In an exploratory analysis, 35 baseline metabolite associations with incident T2D differed across the treatment groups. Stratification by baseline levels of several of these metabolites, including specific phospholipids and AMP, modified the effect that ILS or MET had on diabetes development. Our findings highlight novel markers of diabetes risk and preventative treatment effect in individuals who are clinically at high risk and motivate further studies to validate these interactions.",2019,Novel biomarkers of type 2 diabetes (T2D) and response to preventative treatment in individuals with similar clinical risk may highlight metabolic pathways that are important in disease development.,"['2,015 baseline plasma samples from the Diabetes Prevention Program (DPP', 'individuals with similar clinical risk']","['cytosine', 'metformin (MET), or placebo (PLA']",[],"[{'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0010843', 'cui_str': 'Cytosine'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],331.0,0.0206204,Novel biomarkers of type 2 diabetes (T2D) and response to preventative treatment in individuals with similar clinical risk may highlight metabolic pathways that are important in disease development.,"[{'ForeName': 'Zsu-Zsu', 'Initials': 'ZZ', 'LastName': 'Chen', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Jinxi', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Epidemiology and Biostatistics, Biostatistics Center and Milken Institute School of Public Health, George Washington University, Rockville, MD.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Morningstar', 'Affiliation': 'Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Brandy M', 'Initials': 'BM', 'LastName': 'Heckman-Stoddard', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Christine G', 'Initials': 'CG', 'LastName': 'Lee', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Dagogo-Jack', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': 'Jane F', 'Initials': 'JF', 'LastName': 'Ferguson', 'Affiliation': 'Division of Cardiovascular Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Hamman', 'Affiliation': 'Department of Epidemiology, Colorado School of Public Health, University of Colorado Denver, Aurora, CO.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Knowler', 'Affiliation': 'Diabetes Epidemiology and Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, AZ.'}, {'ForeName': 'Kieren J', 'Initials': 'KJ', 'LastName': 'Mather', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Perreault', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Florez', 'Affiliation': 'Diabetes Unit and Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Wang', 'Affiliation': 'Division of Cardiovascular Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Clary', 'Initials': 'C', 'LastName': 'Clish', 'Affiliation': 'Broad Institute of MIT and Harvard, Cambridge, MA.'}, {'ForeName': 'Marinella', 'Initials': 'M', 'LastName': 'Temprosa', 'Affiliation': 'Department of Epidemiology and Biostatistics, Biostatistics Center and Milken Institute School of Public Health, George Washington University, Rockville, MD.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Gerszten', 'Affiliation': 'Harvard Medical School, Boston, MA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes,['10.2337/db19-0236']
438,31958526,"Buffered lidocaine 1%/epinephrine 1:100,000 with sodium bicarbonate (sodium hydrogen carbonate) in a 3:1 ratio is less painful than a 9:1 ratio: A double-blind, randomized, placebo-controlled, crossover trial.","BACKGROUND


Neutralizing (buffering) lidocaine 1%/epinephrine 1:100,000 solution (Lido/Epi) with sodium hydrogen carbonate (NaHCO 3 ) (also called sodium bicarbonate) is widely used to reduce burning sensations during infiltration of Lido/Epi. Optimal mixing ratios have not been systematically investigated.
OBJECTIVES


To determine whether a Lido/Epi:NaHCO 3  mixing ratio of 3:1 (investigational medicinal product 1) causes less pain during infiltration than a mixing ratio of 9:1 (IMP2) or unbuffered Lido/Epi (IMP3).
METHODS


Double-blind, randomized, placebo-controlled, crossover trial (n = 2 × 24) with 4 investigational medicinal products (IMP1-4).
RESULTS


The 3:1 mixing ratio was significantly less painful than the 9:1 ratio (P = .044). Unbuffered Lido/Epi was more painful than the buffered Lido/Epi (P = .001 vs IMP1; P = .033 vs IMP2). IMP4 (NaCl 0.9% [placebo]) was more painful than any of the anesthetic solutions (P = .001 vs IMP1; P = .001 vs IMP2; P = .016 vs IMP3). In all cases, the anesthesia was effective for at least 3 hours.
LIMITATIONS


Results of this trial cannot be generalized to other local anesthetics such as prilocaine, bupivacaine, or ropivacaine, which precipitate with NaHCO 3  admixtures.
CONCLUSIONS


Lido/Epi-NaHCO 3  mixtures effectively reduce burning pain during infiltration. The 3:1 mixing ratio is significantly less painful than the 9:1 ratio. Reported findings are of high practical relevance, given the extensive use of local anesthesia today.",2020,The 3:1 mixing ratio was significantly less painful than the 9:1 ratio (p = 0.044).,[],"['lidocaine', 'prilocaine, bupivacaine', 'Lido/Epi-NaHCO 3  mixing ratio 3:1 (IMP1', 'IMP2) or unbuffered Lido/Epi (IMP3', '4 investigational medicinal products (IMP1-4', 'ropivacaine', 'epinephrine 1:100,000 solutions (Lido/Epi) with sodium hydrogen carbonate (NaHCO 3 ) (bicarbonate', 'placebo', 'IMP4 (NaCl 0.9%=placebo', 'Unbuffered Lido/Epi', 'sodium bicarbonate (hydrogen carbonate', 'epinephrine']",['burning pain'],[],"[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0033124', 'cui_str': 'Prilocaine'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0267963', 'cui_str': 'Pancreatic Insufficiency'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0005367', 'cui_str': 'Hydrogen Carbonates'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}]","[{'cui': 'C0234230', 'cui_str': 'Pain, Burning'}]",,0.596982,The 3:1 mixing ratio was significantly less painful than the 9:1 ratio (p = 0.044).,"[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Vent', 'Affiliation': 'Department of Dermatology, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Surber', 'Affiliation': 'Department of Dermatology, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Nicole Tracy', 'Initials': 'NT', 'LastName': 'Graf Johansen', 'Affiliation': 'Graf Biostatistics, Winterthur, Switzerland.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Figueiredo', 'Affiliation': 'Hospital Pharmacy of the University Hospital Zurich, Schlieren, Switzerland.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Schönbächler', 'Affiliation': 'Institute of Psychology, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Imhof', 'Affiliation': 'Department of Dermatology, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Buset', 'Affiliation': 'Department of Dermatology, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Jürg', 'Initials': 'J', 'LastName': 'Hafner', 'Affiliation': 'Department of Dermatology, University Hospital of Zurich, Zurich, Switzerland. Electronic address: juerg.hafner@usz.ch.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.09.088']
439,30728457,Randomized phase-II trial evaluating induction therapy with idarubicin and etoposide plus sequential or concurrent azacitidine and maintenance therapy with azacitidine.,"The aim of this randomized phase-II study was to evaluate the effect of substituting cytarabine by azacitidine in intensive induction therapy of patients with acute myeloid leukemia (AML). Patients were randomized to four induction schedules for two cycles: STANDARD (idarubicin, cytarabine, etoposide); and azacitidine given prior (PRIOR), concurrently (CONCURRENT), or after (AFTER) therapy with idarubicin and etoposide. Consolidation therapy consisted of allogeneic hematopoietic-cell transplantation or three courses of high-dose cytarabine followed by 2-year maintenance therapy with azacitidine in the azacitidine-arms. AML with CBFB-MYH11, RUNX1-RUNX1T1, mutated NPM1, and FLT3-ITD were excluded and accrued to genotype-specific trials. The primary end point was response to induction therapy. The statistical design was based on an optimal two-stage design applied for each arm separately. During the first stage, 104 patients (median age 62.6, range 18-82 years) were randomized; the study arms PRIOR and CONCURRENT were terminated early due to inefficacy. After randomization of 268 patients, all azacitidine-containing arms showed inferior response rates compared to STANDARD. Event-free and overall survival were significantly inferior in the azacitidine-containing arms compared to the standard arm (p < 0.001 and p = 0.03, respectively). The data from this trial do not support the substitution of cytarabine by azacitidine in intensive induction therapy.",2019,"Event-free and overall survival were significantly inferior in the azacitidine-containing arms compared to the standard arm (p < 0.001 and p = 0.03, respectively).","['104 patients (median age 62.6, range 18-82 years', 'patients with acute myeloid leukemia (AML']","['cytarabine', 'allogeneic hematopoietic-cell transplantation', 'idarubicin and etoposide plus sequential or concurrent azacitidine and maintenance therapy with azacitidine', 'STANDARD (idarubicin, cytarabine, etoposide); and azacitidine given prior (PRIOR), concurrently (CONCURRENT), or after (AFTER) therapy with idarubicin and etoposide', 'cytarabine by azacitidine']","['Event-free and overall survival', 'inferior response rates', 'response to induction therapy']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}, {'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0004475', 'cui_str': 'Azacitidine'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",268.0,0.0373509,"Event-free and overall survival were significantly inferior in the azacitidine-containing arms compared to the standard arm (p < 0.001 and p = 0.03, respectively).","[{'ForeName': 'R F', 'Initials': 'RF', 'LastName': 'Schlenk', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany. richard.schlenk@nct-heidelberg.de.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Weber', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Herr', 'Affiliation': 'Department of Hematology, Medical Oncology and Pneumology, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Wulf', 'Affiliation': 'Department of Hematology and Oncology, University Hospital of Göttingen, Göttingen, Germany.'}, {'ForeName': 'H R', 'Initials': 'HR', 'LastName': 'Salih', 'Affiliation': 'Department of Hematology and Oncology, Eberhard-Karls University, Tübingen, Germany.'}, {'ForeName': 'H G', 'Initials': 'HG', 'LastName': 'Derigs', 'Affiliation': 'Department of Internal Medicine III, Hospital Frankfurt-Hoechst, Frankfurt, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kuendgen', 'Affiliation': 'Department of Hematology, Oncology and Clinical Immunology, University of Duesseldorf, Medical Faculty, Duesseldorf, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ringhoffer', 'Affiliation': 'Department of Hematology and Oncology, Städtisches Klinikum Karlsruhe, Karlsruhe, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hertenstein', 'Affiliation': 'Department of Hematology and Oncology, Klinikum Bremen Mitte, Bremen, Germany.'}, {'ForeName': 'U M', 'Initials': 'UM', 'LastName': 'Martens', 'Affiliation': 'Department of Hematology and Oncology, University Hospital of Minden, Minden, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Grießhammer', 'Affiliation': 'Department of Hematology and Oncology, University Hospital of Minden, Minden, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Bernhard', 'Affiliation': 'Department of Hematology and Oncology, Darmstadt, Municipal Hospital, Darmstadt, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Krauter', 'Affiliation': 'Department Hematology and Oncology, Braunschweig Municipal Hospital, Braunschweig, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Girschikofsky', 'Affiliation': 'Department of Hematology and Oncology, Hospital Elisabethinen Linz, Linz, Austria.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Wolf', 'Affiliation': 'Internal Medicine III, University Hospital of Bonn, Bonn, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lange', 'Affiliation': 'Department of Hematology and Oncology, Evangelisches Krankenhaus Hamm, Hamm, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Westermann', 'Affiliation': 'Department of Hematology, Oncology and Tumor Immunology, Charité - Campus Virchow Clinic, Berlin, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Koller', 'Affiliation': 'Department of Internal Medicine III, Hanuschkrankenhaus Wien, Wien, Austria.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kremers', 'Affiliation': 'Department of Internal Medicine, Caritas-Krankenhaus Lebach, Lebach, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wattad', 'Affiliation': 'Department of Hematology and Oncology, Hospital Essen-Werden, Essen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Heuser', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Thol', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Göhring', 'Affiliation': 'Institute of Human Genetics, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Haase', 'Affiliation': 'Department of Hematology and Oncology, University Hospital of Göttingen, Göttingen, Germany.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Teleanu', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Gaidzik', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Benner', 'Affiliation': 'Division of Biostatistics, German Cancer Research Center Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ganser', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Paschka', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}]",Leukemia,['10.1038/s41375-019-0395-y']
440,31103018,Neural and behavioral effects of oxytocin administration during theory of mind in schizophrenia and controls: a randomized control trial.,"Social cognitive impairments, including theory of mind (ToM), in schizophrenia more strongly predict functional outcomes than psychotic symptoms or nonsocial cognitive deficits. Despite their clinical importance, current medications do not improve these deficits. The current study investigated the hypothesis that oxytocin, a neuropeptide implicated in social behavior, would normalize neural abnormalities in schizophrenia during ToM, and that this normalization would correlate improvement in ToM behavior. In this cross-over, double-blind, and placebo-controlled functional magnetic resonance imaging study, a single dose of 40 IU of oxytocin was administered via nasal spray to male individuals with a schizophrenia spectrum disorder (schizophrenia and schizoaffective disorder, n = 23) and healthy controls (n = 25). Participants completed two ToM tasks in the scanner, the False Belief and Person Description tasks. During both tasks, on placebo day, schizophrenia was associated with reduced accuracy, hypo-activity in the right temporo-parietal junction (rTPJ; extended into the posterior superior temporal sulcus), and hypo-connectivity between the rTPJ and medial prefrontal cortex (mPFC) compared to healthy controls. Oxytocin, relative to placebo, significantly increased accuracy and rTPJ activation for ToM but not control stories in schizophrenia. Furthermore, a significant positive correlation was found between oxytocin induced increases in rTPJ activity and accuracy, indicating that oxytocin improved rTPJ activity in schizophrenia predicted behavioral improvement. Oxytocin also significantly improved connectivity between rTPJ and mPFC in schizophrenia. These findings suggest that rTPJ activity during ToM might be a potential neural target for the treatment of social cognitive deficits in schizophrenia.",2019,"During both tasks, on placebo day, schizophrenia was associated with reduced accuracy, hypo-activity in the right temporo-parietal junction (rTPJ; extended into the posterior superior temporal sulcus), and hypo-connectivity between the rTPJ and medial prefrontal cortex (mPFC) compared to healthy controls.","['schizophrenia and controls', 'male\xa0individuals with a schizophrenia spectrum disorder (schizophrenia and schizoaffective disorder, n\u2009=\u200923) and healthy controls (n\u2009=\u200925']","['Oxytocin', 'placebo', 'oxytocin']","['rTPJ activity and accuracy', 'accuracy and rTPJ activation', 'Social cognitive impairments, including theory of mind (ToM', 'connectivity', 'reduced accuracy, hypo-activity', 'rTPJ activity']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective Disorder'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0935573', 'cui_str': 'Mentalizing'}]",,0.12082,"During both tasks, on placebo day, schizophrenia was associated with reduced accuracy, hypo-activity in the right temporo-parietal junction (rTPJ; extended into the posterior superior temporal sulcus), and hypo-connectivity between the rTPJ and medial prefrontal cortex (mPFC) compared to healthy controls.","[{'ForeName': 'Lize', 'Initials': 'L', 'LastName': 'De Coster', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Mathalon', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Woolley', 'Affiliation': 'University of California, San Francisco, CA, USA. josh.woolley@ucsf.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0417-5']
441,31308611,Achieving Health Equity with e-Healthystrides©: Patient Perspectives of a Consumer Health Information Technology Application.,"Objective


We describe the implementation, clinical outcomes and participant perspectives for e-Healthystrides©.
Setting


Three independent ambulatory clinics and an historic African American (AA) church.
Participants


Adults with diagnosed diabetes mellitus type 2.
Intervention


e-Healthystrides© health coach facilitated intervention.
Primary outcome


Acquisition of three new self-management behaviors.
Secondary outcomes


Blood pressure, blood glucose, A1c, attrition rate and participant perspectives of e-Healthystrides©.
Methods


A convergent parallel mixed method design was used in both pilot studies.
Results


Two hundred and sixty-four participants, aged ~62±16 years, enrolled. Attrition at 52 weeks varied 50%-90% by site. Low engagement users were defined mainly by anxiety with putting health information online. The primary outcome was achieved in 36% of our participants, with the top 3 self-management behaviors acquired being: reducing risk (24.5%); healthy eating (23.7%); and monitoring (16.4%). Problem solving had the lowest rate of achievement (.91%). Blood pressure improved significantly at all sites at 12 weeks and at clinics A,B,C at 52 weeks. Blood glucose improved at 12 weeks: clinic A (P=.0001), B (P=.003), C (P=.001) and D (P=.03); but, at 52 weeks, only clinics A (P=<.0001) and B (P=.0001). Participants felt empowered by features of e-Healthystrides©. Engagement with health coaches and peers was highly valued.
Conclusions


e-Healthystrides© is effective for self-management behavior change. Participants showed the best success with healthy coping, healthy eating, and monitoring behaviors. They felt empowered by access to health information and valued interaction with coaches and peers. Our findings support strong relational/social network strategy with a role for coaches as guides (apomediaries) who facilitate skill acquisition using technology.",2019,"Blood glucose improved at 12 weeks: clinic A (P=.0001), B (P=.003), C (P=.001) and D (P=.03); but, at 52 weeks, only clinics A (P=<.0001) and B (P=.0001).","['Participants\n\n\nAdults with diagnosed diabetes mellitus type 2', 'Two hundred and sixty-four participants, aged ~62±16 years, enrolled', 'Setting\n\n\nThree independent ambulatory clinics and an historic African American (AA) church']","['e-Healthystrides', 'Intervention\n\n\ne-Healthystrides']","['Blood pressure', 'Acquisition of three new self-management behaviors', 'Blood pressure, blood glucose, A1c, attrition rate and participant perspectives of e-Healthystrides©', 'Attrition', 'Blood glucose', 'healthy eating', 'healthy coping, healthy eating, and monitoring behaviors']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0562324', 'cui_str': 'Church (environment)'}]",[],"[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}]",264.0,0.112118,"Blood glucose improved at 12 weeks: clinic A (P=.0001), B (P=.003), C (P=.001) and D (P=.03); but, at 52 weeks, only clinics A (P=<.0001) and B (P=.0001).","[{'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Pemu', 'Affiliation': 'Morehouse School of Medicine, Department of Medicine and Clinical Research Center; Atlanta, Georgia.'}, {'ForeName': 'Robina', 'Initials': 'R', 'LastName': 'Josiah Willock', 'Affiliation': 'Morehouse School of Medicine, Department of Medicine and Clinical Research Center; Atlanta, Georgia.'}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Alema-Mensa', 'Affiliation': 'Morehouse School of Medicine, Department of Community Health and Preventive Medicine and Clinical Research Center; Atlanta, Georgia.'}, {'ForeName': 'Latrice', 'Initials': 'L', 'LastName': 'Rollins', 'Affiliation': 'Morehouse School of Medicine, Evaluation and Institutional Assessment Unit; Atlanta, Georgia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': 'Morehouse Choice Accountable Care Organization Education System (MCACO-ES); Atlanta, Georgia.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Saint Clair', 'Affiliation': 'Xenn Consulting, Seattle, Washington.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Olorundare', 'Affiliation': 'Morehouse School of Medicine, Department of Medicine and Clinical Research Center; Atlanta, Georgia.'}, {'ForeName': 'Atuarra', 'Initials': 'A', 'LastName': 'McCaslin', 'Affiliation': 'Morehouse School of Medicine, Clinical Research Center; Atlanta, Georgia.'}, {'ForeName': 'Tabia', 'Initials': 'T', 'LastName': 'Henry Akintobi', 'Affiliation': 'Department of Community Health and Preventive Medicine; Morehouse School of Medicine, Evaluation and Institutional Assessment Unit; Atlanta, Georgia.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Quarshie', 'Affiliation': 'Morehouse School of Medicine, Department of Medicine and Clinical Research Center; Atlanta, Georgia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ofili', 'Affiliation': 'Morehouse School of Medicine; Atlanta, Georgia.'}]",Ethnicity & disease,['10.18865/ed.29.S2.393']
442,31317843,Refractory depression - mechanisms and efficacy of radically open dialectical behaviour therapy (RefraMED): findings of a randomised trial on benefits and harms.,"BACKGROUND


Individuals with depression often do not respond to medication or psychotherapy. Radically open dialectical behaviour therapy (RO DBT) is a new treatment targeting overcontrolled personality, common in refractory depression.
AIMS


To compare RO DBT plus treatment as usual (TAU) for refractory depression with TAU alone (trial registration: ISRCTN 85784627).
METHOD


RO DBT comprised 29 therapy sessions and 27 skills classes over 6 months. Our completed randomised trial evaluated RO DBT for refractory depression over 18 months in three British secondary care centres. Of 250 adult participants, we randomised 162 (65%) to RO DBT. The primary outcome was the Hamilton Rating Scale for Depression (HRSD), assessed masked and analysed by treatment allocated.
RESULTS


After 7 months, immediately following therapy, RO DBT had significantly reduced depressive symptoms by 5.40 points on the HRSD relative to TAU (95% CI 0.94-9.85). After 12 months (primary end-point), the difference of 2.15 points on the HRSD in favour of RO DBT was not significant (95% CI -2.28 to 6.59); nor was that of 1.69 points on the HRSD at 18 months (95% CI -2.84 to 6.22). Throughout RO DBT participants reported significantly better psychological flexibility and emotional coping than controls. However, they reported eight possible serious adverse reactions compared with none in the control group.
CONCLUSIONS


The RO DBT group reported significantly lower HRSD scores than the control group after 7 months, but not thereafter. The imbalance in serious adverse reactions was probably because of the controls' limited opportunities to report these.",2020,"After 7 months, immediately following therapy, RO DBT had significantly reduced depressive symptoms by 5.40 points on the HRSD relative to TAU (95% CI 0.94-9.85).","['RO', 'Individuals with depression often do not respond to medication or psychotherapy', '250 adult participants']","['dialectical behaviour therapy (RO DBT', 'RO DBT', 'DBT', 'TAU alone', 'radically open dialectical behaviour therapy (RefraMED']","['depressive symptoms', 'HRSD scores', 'psychological flexibility and emotional coping', 'HRSD in favour of RO DBT', 'Hamilton Rating Scale for Depression (HRSD']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1321145', 'cui_str': 'Dialectical Behavior Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression (assessment scale)'}]",250.0,0.139429,"After 7 months, immediately following therapy, RO DBT had significantly reduced depressive symptoms by 5.40 points on the HRSD relative to TAU (95% CI 0.94-9.85).","[{'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Lynch', 'Affiliation': 'Emeritus Professor of Clinical Psychology, Department of Psychology, University of Southampton, UK.'}, {'ForeName': 'Roelie J', 'Initials': 'RJ', 'LastName': 'Hempel', 'Affiliation': 'Senior Research Fellow, Department of Psychology, University of Southampton, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Whalley', 'Affiliation': 'Lecturer in Psychology, Cognition Institute, School of Psychology, Plymouth University, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Byford', 'Affiliation': ""Professor of Health Economics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK.""}, {'ForeName': 'Rampaul', 'Initials': 'R', 'LastName': 'Chamba', 'Affiliation': 'Patient and Public Representative, Member of Trial Management Committee responsible for Public & Patient Inclusion, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Clarke', 'Affiliation': 'Professor of Social Statistics, Institute for Social and Economic Research, University of Essex, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Clarke', 'Affiliation': 'Visiting Professor, Consultant Clinical Psychologist, Intensive Psychological Therapies Service, Dorset Healthcare University NHS Foundation Trust, UK.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Kingdon', 'Affiliation': 'Professor of Mental Health Care Delivery, Department of Medicine, University of Southampton, UK.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': ""O'Mahen"", 'Affiliation': 'Senior Lecturer in Clinical Psychology, Department of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Remington', 'Affiliation': 'Emeritus Professor in Psychology, Department of Psychology, University of Southampton, UK.'}, {'ForeName': 'Sophie C', 'Initials': 'SC', 'LastName': 'Rushbrook', 'Affiliation': 'Consultant Clinical Psychologist, Intensive Psychological Therapies Service, Dorset Healthcare University NHS Foundation Trust, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Shearer', 'Affiliation': ""Lecturer in Health Economics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK.""}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Stanton', 'Affiliation': 'Consultant Clinical Psychologist, Psychological Services, Southern Health NHS Foundation Trust, UK.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Swales', 'Affiliation': 'Consultant Clinical Psychologist and Reader in Clinical Psychology, School of Psychology, Bangor University, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Watkins', 'Affiliation': 'Associate Professor of e-Trials Research, Medical School, Swansea University, UK.'}, {'ForeName': 'Ian T', 'Initials': 'IT', 'LastName': 'Russell', 'Affiliation': 'Professor of Clinical Trials, Medical School, Swansea University, UK.'}]",The British journal of psychiatry : the journal of mental science,['10.1192/bjp.2019.53']
443,32115419,Treatment Outcomes of Endovascular Embolization Only in Patients with Unruptured Brain Arteriovenous Malformations: A Subgroup Analysis of ARUBA (A Randomized Trial of Unruptured Brain Arteriovenous Malformations).,"BACKGROUND AND PURPOSE


Endovascular embolization only has been advocated for treatment of brain arteriovenous malformations in recent trials. Our aim was to evaluate the results of embolization only in a cohort of patients who were enrolled in the A Randomized Trial of Unruptured Brain Arteriovenous Malformations (ARUBA) study at 39 clinical sites in 9 countries.
MATERIALS AND METHODS


We analyzed the rates and severity of stroke and death in patients who underwent embolization only. Events were identified through in-person neurologic follow-up visits performed at 6-month intervals during the first 2 years and annually, with telephone contact every 6 months thereafter. All event-related data were reviewed by independent adjudicators.
RESULTS


Among 30 patients who had embolization planned, 26 underwent embolization only. A total of 13 stroke events were reported in the follow-up period among 26 subjects (ischemic, hemorrhagic, or both in 4, 7, and 2 subjects, respectively). The adverse event occurred after the first embolization in 11 of 13 patients. One patient had a major motor deficit, and 2 patients developed major visual field deficits. One event was fatal. The modified Rankin Scale score was 0-2 at last follow-up in 11 of the 12 stroke survivors. Estimated stroke-free survival was 46% at 12 months.
CONCLUSIONS


Although the rates of stroke and/or death were high in patients treated with embolization only in ARUBA, the rates of favorable outcomes following stroke were high during follow-up.",2020,The modified Rankin Scale score was 0-2 at last follow-up in 11 of the 12 stroke survivors.,"['patients who underwent embolization only', 'patients who were enrolled in the A Randomized Trial of Unruptured Brain Arteriovenous Malformations (ARUBA) study at 39 clinical sites in 9 countries', 'Patients with Unruptured Brain Arteriovenous Malformations', '30 patients who had embolization planned, 26 underwent embolization only']",['Endovascular Embolization'],"['Estimated stroke-free survival', 'major visual field deficits', 'rates and severity of stroke and death', 'adverse event', 'rates of stroke and/or death', 'modified Rankin Scale score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013931', 'cui_str': 'Embolotherapy'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0003857', 'cui_str': 'Arteriovenous Malformations'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C0013931', 'cui_str': 'Embolotherapy'}]","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0042826', 'cui_str': 'Visual Fields'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0493133,The modified Rankin Scale score was 0-2 at last follow-up in 11 of the 12 stroke survivors.,"[{'ForeName': 'A I', 'Initials': 'AI', 'LastName': 'Qureshi', 'Affiliation': 'From the Zeenat Qureshi Stroke Institute (A.I.Q., O.S., S.S., I.L., J.L.), St. Cloud, Minnesota qureshai@gmail.com.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Saeed', 'Affiliation': 'From the Zeenat Qureshi Stroke Institute (A.I.Q., O.S., S.S., I.L., J.L.), St. Cloud, Minnesota.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sahito', 'Affiliation': 'From the Zeenat Qureshi Stroke Institute (A.I.Q., O.S., S.S., I.L., J.L.), St. Cloud, Minnesota.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Lobanova', 'Affiliation': 'From the Zeenat Qureshi Stroke Institute (A.I.Q., O.S., S.S., I.L., J.L.), St. Cloud, Minnesota.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Liaqat', 'Affiliation': 'From the Zeenat Qureshi Stroke Institute (A.I.Q., O.S., S.S., I.L., J.L.), St. Cloud, Minnesota.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Siddiq', 'Affiliation': 'Division of Neurological Surgery (F.S.), University of Missouri, Colombia, Missouri.'}, {'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Gomez', 'Affiliation': 'Department of Neurology (A.I.Q., C.R.G.) and.'}]",AJNR. American journal of neuroradiology,['10.3174/ajnr.A6443']
444,31057311,Patient-level Predictors of Extent of Exposure to a Community Health Worker Intervention in a Randomized Controlled Trial.,"Objective


Community health worker (CHW) interventions have been cited as a best practice for reducing health disparities, but patient-level attributes may contribute to differential uptake. We examined patient characteristics associated with the extent of exposure to a CHW coaching intervention among a predominantly low-income, African American population participating in a randomized controlled trial of hypertension interventions.
Design


We conducted a within-group longitudinal analysis of those receiving a CHW intervention from a study conducted between September 2003 and August 2005. We employed mixed effects models to ascertain relationships between patients' characteristics, length of time spent with the CHW, and the number of topics discussed during the intervention.
Setting


Baltimore, MD.
Participants


140 patients with a diagnosis of hypertension in the CHW intervention arm.
Results


Marital status, stress, depression symptomology, and having multiple comorbid conditions were each independently and positively related to the length of time patients spent with CHWs. An indirect relationship between higher perceived physical health and time spent with the CHW was observed. Patients with multiple comorbid conditions discussed more intervention-related topics, while patients who perceived themselves as being healthier discussed fewer topics. Marital status and extreme poverty were the strongest predictors of the length of time spent with the CHW, while having multiple comorbid conditions was the strongest predictor of the number of coaching topics discussed.
Conclusions


Differential exposure to a CHW intervention is influenced by patients' physical, psychosocial, and sociodemographic characteristics.",2019,"Marital status and extreme poverty were the strongest predictors of the length of time spent with the CHW, while having multiple comorbid conditions was the strongest predictor of the number of coaching topics discussed.
","['Patients with multiple comorbid conditions discussed more intervention-related topics, while patients who perceived themselves as being healthier discussed fewer topics', 'from a study conducted between September 2003 and August 2005', 'Participants\n\n\n140 patients with a diagnosis of hypertension in the CHW intervention arm']","['CHW intervention', 'Community health worker (CHW) interventions', 'CHW coaching intervention']","['Results\n\n\nMarital status, stress, depression symptomology, and having multiple comorbid conditions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C1275743', 'cui_str': 'Comorbid conditions'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0024819', 'cui_str': 'Marital Status'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C1275743', 'cui_str': 'Comorbid conditions'}]",140.0,0.0308566,"Marital status and extreme poverty were the strongest predictors of the length of time spent with the CHW, while having multiple comorbid conditions was the strongest predictor of the number of coaching topics discussed.
","[{'ForeName': 'Chidinma A', 'Initials': 'CA', 'LastName': 'Ibe', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Bowie', 'Affiliation': 'Department of Health Behavior and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Carson', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Bone', 'Affiliation': 'Department of Health Behavior and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Dwyan', 'Initials': 'D', 'LastName': 'Monroe', 'Affiliation': 'Institute for Public Health Innovation, Washington, DC.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Roter', 'Affiliation': 'Department of Health Behavior and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Cooper', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}]",Ethnicity & disease,['10.18865/ed.29.2.261']
445,31057315,"Longitudinal Changes in Allostatic Load during a Randomized Church-based, Lifestyle Intervention in African American Women.","Introduction


African American (AA) women have disproportionately higher risk of cardiovascular disease than White women, which may be explained by the uniquely higher allostatic load (AL) found in AA women. No studies have tested the effect of lifestyle interventions on AL in AA women. Our objectives were to assess the change in allostatic load following a lifestyle intervention and explore the roles of lifestyle behaviors and socioeconomic factors on allostatic load change.
Methods


Participants were non-diabetic (mean age and SD: 48.8±11.2 y) AA women (n=221) enrolled in a church-based, cluster randomized trial testing a standard diabetes prevention program (DPP) and a faith-enhanced DPP with 4-months of follow-up. We assessed the relationships of changes in diet, physical activity, neighborhood disadvantage, individual socioeconomic factors, and other lifestyle variables to changes in AL at 4-months using a multilevel multinomial logistic regression model.
Results


Average AL decreased (-.13±.99, P=.02) from baseline to 4-months. After adjusting for other variables, a high school education or less (OR:.1, CI:.02-.49) and alcohol use (OR: .31, CI: .09-.99) contributed to increased AL. Living in a disadvantaged neighborhood was responsible for increased AL, though it was not statistically significant. There were no statistically significant associations between AL and other health behavior changes.
Conclusions


Lower education levels may dampen the benefits of lifestyle interventions in reducing AL. Although a significant reduction in AL was found after participation in a lifestyle intervention, more research is needed to determine how lifestyle behaviors and socioeconomic factors influence AL in AA women.",2019,"Average AL decreased (-.13±.99, P=.02) from baseline to 4-months.","['AA women', 'Introduction\n\n\nAfrican American (AA) women', 'African American Women', 'Methods\n\n\nParticipants were non-diabetic (mean age and SD: 48.8±11.2 y) AA women (n=221) enrolled in a church-based, cluster randomized trial testing a']","['Lifestyle Intervention', 'standard diabetes prevention program (DPP) and a faith-enhanced DPP with 4-months of follow-up']","['health behavior changes', 'Average AL']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1293116', 'cui_str': 'Introduction'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0562324', 'cui_str': 'Church (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0018687'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",221.0,0.0679993,"Average AL decreased (-.13±.99, P=.02) from baseline to 4-months.","[{'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Tan', 'Affiliation': 'Bassett Medical Center, Cooperstown, New York.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Mamun', 'Affiliation': 'University of North Texas Health Science Center, Fort Worth, Texas.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Kitzman', 'Affiliation': 'Baylor Scott & White Health, Dallas, Texas.'}, {'ForeName': 'Leilani', 'Initials': 'L', 'LastName': 'Dodgen', 'Affiliation': 'University of North Texas Health Science Center, Fort Worth, Texas.'}]",Ethnicity & disease,['10.18865/ed.29.2.297']
446,32283854,Effects of an Acute Pilates Program under Hypoxic Conditions on Vascular Endothelial Function in Pilates Participants: A Randomized Crossover Trial.,"This study aimed to compare the effects of an acute Pilates program under hypoxic vs. normoxic conditions on the metabolic, cardiac, and vascular functions of the participants. Ten healthy female Pilates experts completed a 50-min tubing Pilates program under normoxic conditions (N trial) and under 3000 m (inspired oxygen fraction = 14.5%) hypobaric hypoxia conditions (H trial) after a 30-min exposure in the respective environments on different days. Blood pressure, branchial ankle pulse wave velocity, and flow-mediated dilation (FMD) in the branchial artery were measured before and after the exercise. Metabolic parameters and cardiac function were assessed every minute during the exercise. Both trials showed a significant increase in FMD; however, the increase in FMD was significantly higher after the H trial than that after the N trial. Furthermore, FMD before exercise was significantly higher in the H trial than in the N trial. In terms of metabolic parameters, minute ventilation, carbon dioxide excretion, respiratory exchange ratio, and carbohydrate oxidation were significantly higher but fat oxidation was lower during the H trial than during the N trial. In terms of cardiac function, heart rate was significantly increased during the H trial than during the N trial. Our results suggested that, compared to that under normoxic conditions, Pilates exercise under hypoxic conditions led to greater metabolic and cardiac responses and also elicited an additive effect on vascular endothelial function.",2020,"In terms of metabolic parameters, minute ventilation, carbon dioxide excretion, respiratory exchange ratio, and carbohydrate oxidation were significantly higher but fat oxidation was lower during the H trial than during the N trial.","['Ten healthy female Pilates experts', 'Pilates Participants']","['acute Pilates program under hypoxic vs. normoxic conditions', '50-min tubing Pilates program under normoxic conditions (N trial) and under 3000 m (inspired oxygen fraction = 14.5%) hypobaric hypoxia conditions', 'Acute Pilates Program under Hypoxic Conditions']","['cardiac function, heart rate', 'Vascular Endothelial Function', 'metabolic and cardiac responses', 'vascular endothelial function', 'metabolic parameters, minute ventilation, carbon dioxide excretion, respiratory exchange ratio, and carbohydrate oxidation', 'FMD', 'FMD before exercise', 'Blood pressure, branchial ankle pulse wave velocity, and flow-mediated dilation (FMD', 'Metabolic parameters and cardiac function', 'metabolic, cardiac, and vascular functions']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C4552489', 'cui_str': 'Hypobaric hypoxia'}]","[{'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0585043', 'cui_str': 'Before exercise'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0232154', 'cui_str': 'Ankle pulse'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}]",10.0,0.0934485,"In terms of metabolic parameters, minute ventilation, carbon dioxide excretion, respiratory exchange ratio, and carbohydrate oxidation were significantly higher but fat oxidation was lower during the H trial than during the N trial.","[{'ForeName': 'Kyounghwa', 'Initials': 'K', 'LastName': 'Jung', 'Affiliation': 'Department of Physical Education, Konkuk University, 120 Neungdong-ro, Gwangjin-gu, Seoul 05029, Korea.'}, {'ForeName': 'Jongbeom', 'Initials': 'J', 'LastName': 'Seo', 'Affiliation': 'Department of Physical Education, Konkuk University, 120 Neungdong-ro, Gwangjin-gu, Seoul 05029, Korea.'}, {'ForeName': 'Won-Sang', 'Initials': 'WS', 'LastName': 'Jung', 'Affiliation': 'Physical Activity and Performance Institute (PAPI), Konkuk University, 120 Neungdong-ro, Gwangjin-gu, Seoul 05029, Korea.'}, {'ForeName': 'Jisu', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Physical Activity and Performance Institute (PAPI), Konkuk University, 120 Neungdong-ro, Gwangjin-gu, Seoul 05029, Korea.'}, {'ForeName': 'Hun-Young', 'Initials': 'HY', 'LastName': 'Park', 'Affiliation': 'Physical Activity and Performance Institute (PAPI), Konkuk University, 120 Neungdong-ro, Gwangjin-gu, Seoul 05029, Korea.'}, {'ForeName': 'Kiwon', 'Initials': 'K', 'LastName': 'Lim', 'Affiliation': 'Department of Physical Education, Konkuk University, 120 Neungdong-ro, Gwangjin-gu, Seoul 05029, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17072584']
447,32221086,Physical and psychological effects of different temperature-controlled breast prostheses on patients with breast cancer during rehabilitation: a randomized controlled study (CONSORT).,"BACKGROUND


Breast loss causes negative influence on women physically, psychologically, and socially. Breast prosthesis can improve patient's figure externally, increase self-confidence, thus improving quality of life (QOL). Prospective study of different breast prostheses has not yet been performed in China. Our objective was to evaluate the QOL of patients wearing different types of breast prostheses and to compare the physical and psychological effects of different temperature-controlled breast prostheses on patients.
METHODS


Thirty patients with breast cancer were recruited through the Yankang E-follow-up Platform at the Department of Breast Surgery of Fudan University, Shanghai Cancer Center and were randomized into either intervention or control group. Random number tables were used in this study for randomization. In the first 6 weeks of the study, self-adhesive breast prostheses and conventional breast prostheses had been used in the intervention and control group, respectively. In the later 6 weeks, the breast prostheses used were switched into another kind. Several dimensional parameters including skin conditions, breast prosthesis knowledge, breast prosthesis knowledge, QOL, and body image were examined by different questionnaires in the end of both 6th and 12th week.
RESULTS


There were no significant difference in QOL and body image between the 2 groups during 6th and 12th week. At the 6th week of the study, patients of the intervention group preferred to the self-adhesive breast prosthesis, indicating that the self-adhesive breast prosthesis seemed more likely to feel like part of their body, while prosthesis cleaning remaining their biggest concern. At the end of 12th week, in comparison with the number at 6th week, more patients in both groups were willing to choose self-adhesive breast prosthesis.
CONCLUSIONS


We conclude that women are satisfied with the temperature-controlled breast prosthesis and are more willing to choose self-adhesive breast prostheses although cleaning remains a problem. In China, patients still lack information about breast prostheses. Therefore, specialist breast nurses should provide comprehensive information about breast prostheses, assist patients in selecting suitable breast prostheses, collect feedback about the prostheses, and reduce each patient's physical and mental discomfort.",2020,"Breast prosthesis can improve patient's figure externally, increase self-confidence, thus improving quality of life (QOL).","['patients', 'Thirty patients with breast cancer were recruited through the Yankang E-follow-up Platform at the Department of Breast Surgery of Fudan University, Shanghai Cancer Center', 'patients with breast cancer during rehabilitation']",['temperature-controlled breast prostheses'],"['skin conditions, breast prosthesis knowledge, breast prosthesis knowledge, QOL, and body image', 'Physical and psychological effects', 'quality of life (QOL', 'QOL and body image']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0851312', 'cui_str': 'Breast surgery'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0179412', 'cui_str': 'Breast Prosthesis, Internal'}]","[{'cui': 'C1719933', 'cui_str': 'Skin condition'}, {'cui': 'C0179412', 'cui_str': 'Breast Prosthesis, Internal'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0034380'}]",30.0,0.0147478,"Breast prosthesis can improve patient's figure externally, increase self-confidence, thus improving quality of life (QOL).","[{'ForeName': 'Jiajia', 'Initials': 'J', 'LastName': 'Qiu', 'Affiliation': 'Department of Nursing Administration, Shanghai Cancer Center.'}, {'ForeName': 'Lichen', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': 'Department of Oncology, Shanghai Medical College.'}, {'ForeName': 'Lijin', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Nursing Administration, Shanghai Cancer Center.'}, {'ForeName': 'Shengqun', 'Initials': 'S', 'LastName': 'Hou', 'Affiliation': 'Department of Nursing Administration, Shanghai Cancer Center.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Nursing Administration, Shanghai Cancer Center.'}]",Medicine,['10.1097/MD.0000000000019616']
448,32283727,Implicit Theories about Athletic Ability Modulate the Effects of If-Then Planning on Performance in a Standardized Endurance Task.,"Muscular strength has a strong positive impact on cardiometabolic health and fitness. However, building up strength endurance requires effortful exercises. From a health perspective, it is important to understand which psychological strategies help people deal with straining exercise. Self-regulation strategies like if-then planning (also known as implementation intentions) appear particularly promising because they might directly alter how people deal with exercise-induced sensations. However, research on the effects of if-then planning on exercise performance has yielded mixed results so far. One possible reason for these inconsistent results is the lack of tailored interventions and the neglect of potential moderators. To address this, we investigated the efficacy of if-then plans that were tailored to perceived limits of endurance performance (i.e., perceptions of exertion versus pain). In addition, we investigated the effects of these tailored if-then plans while taking into account the potentially moderating effects of individual differences in implicit theories. Specifically, we were interested in the role of implicit theories about athletic performance (i.e., entity versus incremental beliefs) and about the limitation of athletic performance by mental versus physical factors (i.e., mind-over-body beliefs).  N  = 66 male students (age:  M  = 25.8 years,  SD  = 3.2) performed a static muscular endurance task twice (measurement: baseline task vs. main task) and were randomly assigned to a goal or an implementation intention condition. They were instructed to hold two intertwined rings for as long as possible while avoiding contacts between them (measure of performance: time-to-failure and errors). After the baseline task, participants were either given an implementation intention or were simply asked to rehearse the task instructions. The content of the instruction depended on whether they ascribed ultimate baseline task termination to perceptions of exertion or pain. After the main task, implicit theories on athletic ability were assessed. No differences in performance emerged between conditions. In the implementation intention condition, however, stronger entity beliefs were associated with increasing time-to-failure when participants planned to ignore exertion but with decreasing time-to-failure when they planned to ignore pain. This pattern of results was reversed with regard to mind-over-body beliefs. These findings indicate that the efficacy of psychological strategies hinges on recreational athletes' beliefs regarding athletic performance.",2020,No differences in performance emerged between conditions.,"['N  = 66 male students (age:  M  = 25.8 years,  SD  = 3.2) performed a']",['static muscular endurance task twice (measurement: baseline task vs. main task'],['athletic ability'],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",66.0,0.0754246,No differences in performance emerged between conditions.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hirsch', 'Affiliation': 'Sport Psychology, Department of Sport Science, University of Konstanz, 78464 Konstanz, Germany.'}, {'ForeName': 'Maik', 'Initials': 'M', 'LastName': 'Bieleke', 'Affiliation': 'Educational Psychology, Department of Psychology, University of Vienna, 1010 Vienna, Austria.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Schüler', 'Affiliation': 'Sport Psychology, Department of Sport Science, University of Konstanz, 78464 Konstanz, Germany.'}, {'ForeName': 'Wanja', 'Initials': 'W', 'LastName': 'Wolff', 'Affiliation': 'Sport Psychology, Department of Sport Science, University of Konstanz, 78464 Konstanz, Germany.'}]",International journal of environmental research and public health,['10.3390/ijerph17072576']
449,31577356,Effect of a Novel Transition Program on Disability After Stroke: A Trial Protocol.,"Importance


A gap in care for stroke survivors exists at the point of transition from inpatient rehabilitation to home, when survivors encounter new environmental barriers because of the cognitive and sensorimotor sequelae of stroke. Resolving these barriers and improving independence in the community have the potential to significantly improve stroke survivors' long-term morbidity.
Objective


To investigate the efficacy and safety of a novel enhanced rehabilitation transition program to reduce environmental barriers and improve daily activity performance and community participation among stroke survivors.
Design, Setting, and Participants


This is a phase 2b, single-blind, parallel-group, randomized clinical trial. Participants will be randomized using a 1:1 allocation ratio, stratified by Functional Independence Measure and age, to either attentional control or the intervention. Community Participation Transition After Stroke (COMPASS) is a complex intervention that uses 2 complementary evidence-based interventions: home modifications and strategy training delivered in the home. Community participation after stroke, measured by the Reintegration to Normal Living Index, is the primary outcome. Secondary outcomes include quality of life after stroke, measured by the Stroke Impact Scale, and daily activity performance and magnitude of environmental barriers in the home, both measured by the In-Home Occupational Performance Evaluation. An intention-to-treat analysis will be used. A total of 180 participants, who are 50 years or older, were independent in activities of daily living prior to stroke, and are undergoing inpatient rehabilitation following stroke with a plan to be discharged home, will be included in the study.
Discussion


Stroke is a leading cause of serious long-term disability in the United States. The COMPASS study is ongoing. To date, 99 participants have been recruited and 77 randomized, with 37 in the treatment group and 40 in the control group. Resumption of previous activities immediately after discharge can improve immediate and long-term community participation. Results from this study will fill a critical gap in stroke rehabilitation evidence by providing important information about the long-term community participation and daily activity performance among stroke survivors as well as environmental barriers in their homes.
Trial Registration


ClinicalTrials.gov identifier: NCT03485820.",2019,"A total of 180 participants, who are 50 years or older, were independent in activities of daily living prior to stroke, and are undergoing inpatient rehabilitation following stroke with a plan to be discharged home, will be included in the study.
","['99 participants have been recruited and 77 randomized, with 37 in the treatment group and 40 in the control group', '180 participants, who are 50 years or older, were independent in activities of daily living prior to stroke, and are undergoing inpatient rehabilitation following stroke with a plan to be discharged home, will be included in the study']","['Novel Transition Program', 'novel enhanced rehabilitation transition program']","['quality of life after stroke, measured by the Stroke Impact Scale, and daily activity performance and magnitude of environmental barriers in the home, both measured by the In-Home Occupational Performance Evaluation', 'efficacy and safety', 'daily activity performance', 'Disability']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0034380'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0521127', 'cui_str': 'Occupational (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",180.0,0.161571,"A total of 180 participants, who are 50 years or older, were independent in activities of daily living prior to stroke, and are undergoing inpatient rehabilitation following stroke with a plan to be discharged home, will be included in the study.
","[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Somerville', 'Affiliation': 'School of Medicine, Washington University in St Louis, St Louis, Missouri.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Minor', 'Affiliation': 'School of Medicine, Washington University in St Louis, St Louis, Missouri.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Keglovits', 'Affiliation': 'School of Medicine, Washington University in St Louis, St Louis, Missouri.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'School of Medicine, Washington University in St Louis, St Louis, Missouri.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Stark', 'Affiliation': 'School of Medicine, Washington University in St Louis, St Louis, Missouri.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.12356']
450,31727538,"Optimal sequencing of enzalutamide and abiraterone acetate plus prednisone in metastatic castration-resistant prostate cancer: a multicentre, randomised, open-label, phase 2, crossover trial.","BACKGROUND


Abiraterone acetate plus prednisone and enzalutamide are both used for the treatment of metastatic castration-resistant prostate cancer. We aimed to determine the best sequence in which to use both drugs, as well as their second-line efficacy.
METHODS


In this multicentre, randomised, open-label, phase 2, crossover trial done in six cancer centres in British Columbia, Canada, we recruited patients aged 18 years or older with newly-diagnosed metastatic castration-resistant prostate cancer without neuroendocrine differentiation and Eastern Cooperative Oncology Group performance status 2 or less. Patients were randomly assigned (1:1) using a computer-generated random number table to receive either abiraterone acetate 1000 mg orally once daily plus prednisone 5 mg orally twice daily until PSA progression followed by crossover to enzalutamide 160 mg orally once daily (group A), or the opposite sequence (group B). Treatment was not masked to investigators or participants. Primary endpoints were time to second PSA progression and PSA response (≥30% decline from baseline) on second-line therapy, analysed by intention-to-treat in all randomly assigned patients and in patients who crossed over, respectively. The trial is registered with ClinicalTrials.gov, NCT02125357.
FINDINGS


Between Oct 21, 2014, and Dec 13, 2016, 202 patients were enrolled and randomly assigned to either group A (n=101) or group B (n=101). At the time of data cutoff, 73 (72%) patients in group A and 75 (74%) patients in group B had crossed over. Time to second PSA progression was longer in group A than in group B (median 19·3 months [95% CI 16·0-30·5] vs 15·2 months [95% CI 11·9-19·8] months; hazard ratio 0·66, 95% CI 0·45-0·97, p=0·036), at a median follow-up of 22·8 months (IQR 10·3-33·4). PSA responses to second-line therapy were seen in 26 (36%) of 73 patients for enzalutamide and three (4%) of 75 for abiraterone (χ 2  p<0·0001). The most common grade 3-4 adverse events throughout the trial were hypertension (27 [27%] of 101 patients in group A vs 18 [18%] of 101 patients in group B) and fatigue (six [10%] vs four [4%]). Serious adverse events were reported in 15 (15%) of 101 patients in group A and 20 (20%) of 101 patients in group B. There were no treatment-related deaths.
INTERPRETATION


Enzalutamide showed activity as a second-line novel androgen receptor pathway inhibitor, whereas abiraterone acetate did not, leading to a longer time to second PSA progression for the sequence of abiraterone followed by enzalutamide than with the opposite treatment sequence. Our data suggest that using a sequencing strategy of abiraterone acetate followed by enzalutamide provides the greatest clinical benefit.
FUNDING


Canadian Cancer Society Research Institute, Prostate Cancer Canada, Movember Foundation, Prostate Cancer Foundation, Terry Fox New Frontiers Program, BC Cancer Foundation, Jane and Aatos Erkko Foundation, Janssen, and Astellas.",2019,PSA responses to second-line therapy were seen in 26 (36%) of 73 patients for enzalutamide and three (4%) of 75 for abiraterone (χ 2  p<0·0001).,"['six cancer centres in British Columbia, Canada, we recruited patients aged 18 years or older with newly-diagnosed metastatic castration-resistant prostate cancer without neuroendocrine differentiation and Eastern Cooperative Oncology Group performance status 2 or less', 'metastatic castration-resistant prostate cancer', 'Between Oct 21, 2014, and Dec 13, 2016, 202 patients']","['Abiraterone acetate plus prednisone and enzalutamide', 'enzalutamide', 'enzalutamide and abiraterone acetate plus prednisone', 'abiraterone acetate', 'abiraterone acetate 1000 mg orally once daily plus prednisone']","['Time to second PSA progression', 'PSA responses', 'Serious adverse events', 'fatigue', 'time to second PSA progression and PSA response']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0006193', 'cui_str': 'British Columbia'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0332288', 'cui_str': 'Without (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}]","[{'cui': 'C2607886', 'cui_str': 'abiraterone acetate'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",202.0,0.17203,PSA responses to second-line therapy were seen in 26 (36%) of 73 patients for enzalutamide and three (4%) of 75 for abiraterone (χ 2  p<0·0001).,"[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Khalaf', 'Affiliation': 'Division of Medical Oncology, BC Cancer, Vancouver, BC, Canada.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Annala', 'Affiliation': 'Vancouver Prostate Centre, Vancouver, BC, Canada; Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Sinja', 'Initials': 'S', 'LastName': 'Taavitsainen', 'Affiliation': 'Vancouver Prostate Centre, Vancouver, BC, Canada; Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Daygen L', 'Initials': 'DL', 'LastName': 'Finch', 'Affiliation': 'BC Cancer, Kelowna, BC, Canada.'}, {'ForeName': 'Conrad', 'Initials': 'C', 'LastName': 'Oja', 'Affiliation': 'BC Cancer, Surrey, BC, Canada.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Vergidis', 'Affiliation': 'BC Cancer, Victoria, BC, Canada.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Zulfiqar', 'Affiliation': 'BC Cancer, Abbotsford, BC, Canada.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Sunderland', 'Affiliation': 'Division of Cancer Surveillance and Outcomes, BC Cancer, Vancouver, BC, Canada.'}, {'ForeName': 'Arun A', 'Initials': 'AA', 'LastName': 'Azad', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Christian K', 'Initials': 'CK', 'LastName': 'Kollmannsberger', 'Affiliation': 'Division of Medical Oncology, BC Cancer, Vancouver, BC, Canada.'}, {'ForeName': 'Bernhard J', 'Initials': 'BJ', 'LastName': 'Eigl', 'Affiliation': 'Division of Medical Oncology, BC Cancer, Vancouver, BC, Canada.'}, {'ForeName': 'Krista', 'Initials': 'K', 'LastName': 'Noonan', 'Affiliation': 'BC Cancer, Surrey, BC, Canada.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Wadhwa', 'Affiliation': 'BC Cancer, Kelowna, BC, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Attwell', 'Affiliation': 'BC Cancer, Victoria, BC, Canada.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Keith', 'Affiliation': 'BC Cancer, Abbotsford, BC, Canada.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Ellard', 'Affiliation': 'BC Cancer, Kelowna, BC, Canada.'}, {'ForeName': 'Lyly', 'Initials': 'L', 'LastName': 'Le', 'Affiliation': 'BC Cancer, Surrey, BC, Canada.'}, {'ForeName': 'Martin E', 'Initials': 'ME', 'LastName': 'Gleave', 'Affiliation': 'Vancouver Prostate Centre, Vancouver, BC, Canada.'}, {'ForeName': 'Alexander W', 'Initials': 'AW', 'LastName': 'Wyatt', 'Affiliation': 'Vancouver Prostate Centre, Vancouver, BC, Canada.'}, {'ForeName': 'Kim N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': 'Division of Medical Oncology, BC Cancer, Vancouver, BC, Canada; Vancouver Prostate Centre, Vancouver, BC, Canada. Electronic address: kchi@bccancer.bc.ca.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30688-6']
451,30959514,Neurophysiological signature of gamma-hydroxybutyrate augmented sleep in male healthy volunteers may reflect biomimetic sleep enhancement: a randomized controlled trial.,"Gamma-hydroxybutyrate (GHB) is an endogenous GHB/GABA B  receptor agonist, which has demonstrated potency in consolidating sleep and reducing excessive daytime sleepiness in narcolepsy. Little is known whether GHB's efficacy reflects the promotion of physiological sleep mechanisms and no study has investigated its sleep consolidating effects under low sleep pressure. GHB (50 mg/kg p.o.) and placebo were administered in 20 young male volunteers at 2:30 a.m., the time when GHB is typically given in narcolepsy, in a randomized, double-blinded, crossover manner. Drug effects on sleep architecture and electroencephalographic (EEG) sleep spectra were analyzed. In addition, current source density (CSD) analysis was employed to identify the effects of GHB on the brain electrical sources of neuronal oscillations. Moreover, lagged-phase synchronization (LPS) analysis was applied to quantify the functional connectivity among sleep-relevant brain regions. GHB prolonged slow-wave sleep (stage N3) at the cost of rapid eye movement (REM) sleep. Furthermore, it enhanced delta-theta (0.5-8 Hz) activity in NREM and REM sleep, while reducing activity in the spindle frequency range (13-15 Hz) in sleep stage N2. The increase in delta power predominated in medial prefrontal cortex, parahippocampal and fusiform gyri, and posterior cingulate cortex. Theta power was particularly increased in the prefrontal cortex and both temporal poles. Moreover, the brain areas that showed increased theta power after GHB also exhibited increased lagged-phase synchronization among each other. Our study in healthy men revealed distinct similarities between GHB-augmented sleep and physiologically augmented sleep as seen in recovery sleep after prolonged wakefulness. The promotion of the sleep neurophysiological mechanisms by GHB may thus provide a rationale for GHB-induced sleep and waking quality in neuropsychiatric disorders beyond narcolepsy.",2019,"The increase in delta power predominated in medial prefrontal cortex, parahippocampal and fusiform gyri, and posterior cingulate cortex.","['20 young male volunteers', 'healthy men', 'male healthy volunteers']","['gamma-hydroxybutyrate augmented sleep', 'placebo', 'GHB', 'Gamma-hydroxybutyrate (GHB']","['sleep architecture and electroencephalographic (EEG) sleep spectra', 'delta power predominated in medial prefrontal cortex, parahippocampal and fusiform gyri, and posterior cingulate cortex', 'biomimetic sleep enhancement', 'GHB prolonged slow-wave sleep (stage N3', 'Theta power']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0000503', 'cui_str': '4-Hydroxybutyrate (substance)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0332251', 'cui_str': 'Predominate (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0228243', 'cui_str': 'Gyrus Fusiformis'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate'}, {'cui': 'C0872312', 'cui_str': 'Biomimicry Engineering'}, {'cui': 'C0184578', 'cui_str': 'Sleep/wake cycle facilitation'}, {'cui': 'C0000503', 'cui_str': '4-Hydroxybutyrate (substance)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0234451', 'cui_str': 'Sleep, Slow-Wave'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}]",20.0,0.0596478,"The increase in delta power predominated in medial prefrontal cortex, parahippocampal and fusiform gyri, and posterior cingulate cortex.","[{'ForeName': 'Dario A', 'Initials': 'DA', 'LastName': 'Dornbierer', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zürich, Zürich, Switzerland. dornbierer@pharma.uzh.ch.'}, {'ForeName': 'Diego M', 'Initials': 'DM', 'LastName': 'Baur', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Stucky', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Boris B', 'Initials': 'BB', 'LastName': 'Quednow', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zürich, Lenggstrasse 31, Zürich, CH-8032, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kraemer', 'Affiliation': 'Department of Forensic Pharmacology and Toxicology, Zurich Institute of Forensic Medicine, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Seifritz', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zürich, Lenggstrasse 31, Zürich, CH-8032, Switzerland.'}, {'ForeName': 'Oliver G', 'Initials': 'OG', 'LastName': 'Bosch', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zürich, Lenggstrasse 31, Zürich, CH-8032, Switzerland.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Landolt', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zürich, Zürich, Switzerland.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0382-z']
452,32221061,The effect of short foot exercise using visual feedback on the balance and accuracy of knee joint movement in subjects with flexible flatfoot.,"BACKGROUND


Flexible flatfoot is a condition characterized by the deformations of the foot where the calcaneus is pronated by weight support. Flat feet can affect balance and the entire chain of motion, causing indirect problems in adjacent joints. We investigated the effects of short foot exercise (SFE) using visual feedback on the static balance and function of proximal joints in subjects with flexible flat feet.
METHOD AND ANALYSIS


This study involved 30 participants who were assigned to either of the 2 groups: the flexible flatfoot group (n = 15, 8 men and 7 women, aged 22.00 ± 2.07 years) and normal foot group (n = 15, 7 men and 8 women, aged 22.13 ± 1.55 years). All subjects performed the SFE with visual feedback. SFE programs were performed 20 minutes a day, 5 times a week, for a total of 5 weeks. The static balance and accuracy of knee joint motions were compared before and after training.
RESULTS


There was a significant difference in static balance pre- and post-exercise in the flatfoot group but not in the normal foot group. Moreover, in the flatfoot group, the accuracy of knee joint motions was significantly different between pre- and post-exercise in the closed chain but not in the open chain.
CONCLUSION


This study examined the influence of SFE using visual feedback on the balance and accuracy of knee joint movements in subjects with flatfoot and demonstrated that this exercise, using visual feedback, improved the balance and accuracy of knee movement.",2020,There was a significant difference in static balance pre- and post-exercise in the flatfoot group but not in the normal foot group.,"['subjects with flatfoot', '30 participants who were assigned to either of the 2 groups: the flexible flatfoot group (n\u200a=\u200a15, 8 men and 7 women, aged 22.00\u200a±\u200a2.07 years) and normal foot group (n\u200a=\u200a15, 7 men and 8 women, aged 22.13\u200a±\u200a1.55 years', 'subjects with flexible flat feet', 'subjects with flexible flatfoot']","['short foot exercise using visual feedback', 'short foot exercise (SFE) using visual feedback', 'SFE using visual feedback']","['static balance and function of proximal joints', 'static balance pre- and post-exercise', 'accuracy of knee joint motions', 'static balance and accuracy of knee joint motions']","[{'cui': 'C0016202', 'cui_str': 'Splayfoot'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0152237', 'cui_str': 'Talipes Calcaneovalgus'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}]","[{'cui': 'C0576226', 'cui_str': 'Short foot (finding)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C1870204', 'cui_str': '(18F)SFE'}]","[{'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C0022745', 'cui_str': 'Superior Tibiofibular Joint'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}]",30.0,0.0197517,There was a significant difference in static balance pre- and post-exercise in the flatfoot group but not in the normal foot group.,"[{'ForeName': 'Ju Sang', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy and Rehabilitation, Yeungnam University Hospital, Daegu.'}, {'ForeName': 'Mi Young', 'Initials': 'MY', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, College of Biomedical Science, Daegu Haany University, Gyeongsansi, Republic of Korea.'}]",Medicine,['10.1097/MD.0000000000019260']
453,32221067,Evaluation of the effects of photobiomodulation on orthodontic movement of molar verticalization with mini-implant: A randomized double-blind protocol study.,"INTRODUCTION


Loss of a dental element can generate several repercussions in the stomatognathic system. According to the latest survey by the Ministry of Health, in 2010, Brazilian adults had, on average, 7 missing teeth. This loss may lead to movement of the adjacent teeth and the antagonist, which would make prosthetic rehabilitation harder to do. Anchoring systems, such as mini-implants, have been increasingly used as a treatment option because they act with heavy but controlled forces and without side effects. Recent studies have shown that photobiomodulation (PBM) can accelerate orthodontic movement in molar intrusion. The objective of this study will be to evaluate the effect of PBM on the acceleration of the orthodontic movement of molar verticalization and its effect on pain and inflammation of the periodontal tissues. PATIENT CONCERNS:: the concerns assessments will be done over the study using anamnesis interviews and specific questionnaire.
DIAGNOSIS


verticalization will be evaluated by clinical and radiographic analysis.
INTERVENTIONS


Thirty four healthy patients aged 30 to 60 years, who need to recover the prosthetic space for oral rehabilitation after loss of the posterior inferior dental elements and inclination of the adjacent element, will be randomly divided into 2 groups: G1 (control group) - verticalization by mini-implant + PBM simulation (placebo); G2 (experimental group) - verticalization by mini-implant + PBM. The movements will occur with the aid of mini-implants and elastomeric chains ligatures. The PBM will occur with diode laser application, 808 nm, 100 mW, receiving 1J per point, 10 seconds, 10 points (5 per buccal and 5 per lingual) and radiant exposure of 25 J/cm. The orthodontic forces of verticalization (corresponding to any exchange of elastomeric ligation) will be applied every 30 days and the PBM will be applied immediately, 3 and 7 days of each month, for a period of 3 months. The crevicular gingival fluid (CGF) will be collected on the 1st, 3rd, and 7th days after the first activation, and then on the 3rd day of the following 2 months.
OUTCOMES


Interleukins IL1β, IL-6, IL-8, IL-10, and TNF-α will be analyzed by ELISA. Panoramic radiography will be performed at baseline and 90 afterwards to ascertain the amount (in degrees) of verticalization. To evaluate the pain, the Visual Analog Scale (VAS) will be used in all the consultations, and to evaluate the quality of life, the Oral Health Impact Profile (OHIP-14) questionnaire will be applied. Analgesics will be given and the quantity of drugs will be counted. If the data are normal, they will be submitted to Student t test. The data will be presented as means ± SD and the value of p will be defined as <0.05.
DISCUSSION


This protocol will determine the effectiveness of photobiomoduation regarding the orthodontic movement of molar verticalization.
ETHICS AND DISSEMINATION


This protocol received approval from the Human Research Ethics Committee of Universidade Nove de Julho (certificate number: 3 533 219). The data will be published in a peer-reviewed periodical.",2020,"OUTCOMES


Interleukins IL1β, IL-6, IL-8, IL-10, and TNF-α will be analyzed by ELISA.","['2010, Brazilian adults had, on average, 7 missing teeth', 'Thirty', 'four healthy patients aged 30 to 60 years, who need to recover the prosthetic space for oral rehabilitation after loss of the posterior inferior dental elements and inclination of the adjacent element']","['Panoramic radiography', 'PBM', 'G1 (control group) - verticalization by mini-implant + PBM simulation (placebo); G2 (experimental group) - verticalization by mini-implant + PBM', 'photobiomodulation (PBM', 'photobiomodulation', 'molar verticalization with mini-implant']","['pain, the Visual Analog Scale (VAS', 'pain and inflammation of the periodontal tissues', 'quality of life, the Oral Health Impact Profile (OHIP-14) questionnaire', 'Interleukins IL1β, IL-6, IL-8, IL-10, and TNF-α will be analyzed by ELISA', 'crevicular gingival fluid (CGF']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0419104', 'cui_str': 'Oral rehabilitation (regime/therapy)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0013879', 'cui_str': 'Elements'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed (qualifier value)'}]","[{'cui': 'C0034579', 'cui_str': 'Panoramic Radiography'}, {'cui': 'C0071006', 'cui_str': 'phytobacteriomycin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0031104', 'cui_str': 'Tooth Supporting Structures'}, {'cui': 'C0034380'}, {'cui': 'C0029162'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C4521854', 'cui_str': 'Gingival (intended site)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}]",34.0,0.0769534,"OUTCOMES


Interleukins IL1β, IL-6, IL-8, IL-10, and TNF-α will be analyzed by ELISA.","[{'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Murakami-Malaquias-Silva', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE.'}, {'ForeName': 'Ellen Perim', 'Initials': 'EP', 'LastName': 'Rosa', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE.'}, {'ForeName': 'Paulo André', 'Initials': 'PA', 'LastName': 'Almeida', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE.'}, {'ForeName': 'Tânia Oppido', 'Initials': 'TO', 'LastName': 'Schalch', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE.'}, {'ForeName': 'Carlos Alberto', 'Initials': 'CA', 'LastName': 'Tenis', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE.'}, {'ForeName': 'Renata Matalon', 'Initials': 'RM', 'LastName': 'Negreiros', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE.'}, {'ForeName': 'Ricardo Fidos', 'Initials': 'RF', 'LastName': 'Horliana', 'Affiliation': 'Academic specialization student in Temporomandibular Disorder and Orofacial pain, Universidade Nove de Julho, UNINOVE.'}, {'ForeName': 'Aguinaldo Silva', 'Initials': 'AS', 'LastName': 'Garcez', 'Affiliation': 'São Leopoldo Mandic, School of Dentistry, Campinas.'}, {'ForeName': 'Marcella Ueda R', 'Initials': 'MUR', 'LastName': 'Fernandes', 'Affiliation': 'São Leopoldo Mandic, School of Dentistry, Campinas.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Tortamano', 'Affiliation': 'Coordinator of Graduation course.'}, {'ForeName': 'Lara Jansiski', 'Initials': 'LJ', 'LastName': 'Motta', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE.'}, {'ForeName': 'Sandra Kalil', 'Initials': 'SK', 'LastName': 'Bussadori', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE.'}, {'ForeName': 'Anna Carolina Ratto Tempestini', 'Initials': 'ACRT', 'LastName': 'Horliana', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE.'}]",Medicine,['10.1097/MD.0000000000019430']
454,32221070,Effect of sub-hypothermia blood purification technique in cardiac shock after valvular disease surgery.,"To observe the effect of sub-hypothermia (HT) blood purification technique in the treatment of cardiac shock after heart valve disease.The patients were randomly divided into normothermic (NT) continuous blood purification (CBP) group (NT group) and HT CBP group (HT group). Observe the cardiac index (CI), the oxygen delivery (DO2) and oxygen consumption (VO2) ratio, Acute Physiology and Chronic Health Evaluation III(APACHE III) score, multiple organ dysfunction syndrome (MODS) score, dynamic monitoring of electrocardiograph, blood loss with or without muscle tremors, intensive care unit stay, mechanical ventilation time, CBP time, and the cases of infection and mortality at 0 day, 1 day, 2 day, 3 day; all above indicators were compared between 2 groups.Ninety-five patients were randomly assigned into HT group (48 cases) and NT group (47 cases); there were no significant differences between the 2 groups for age, gender, pre-operative cardiac function, cardiothoracic ratio, and type of valve replacement (P > .05). There were no significant differences among the 1 day, 2 day, 3 day after recruited for CI, DO2/VO2 ratio, APACHE III score, MODS score (P > .05). But in HT group, DO2/VO2 ratio had been significantly improved after treatment for 1 day (2.5 ± 0.7 vs 1.8 ± 0.4, P = .024), and CI (3.0 ± 0.5 vs 1.9 ± 0.7, P = .004), APACHE III score (50.6 ± 6.2 vs 77.5 ± 5.5 P = .022), MODS score (6.0 ± 1.5 vs 9.3 ± 3.4, P = .013) also had been significantly improved after treatment for 3 days. In clinical outcomes, there were no significant differences between 2 groups for blood loss (617.0 ± 60.7 ml vs 550.9 ± 85.2 ml, P = .203), infection ratio (54.17% vs 53.19%, P = .341), the incidence of ventricular arrhythmia (31.25% vs 36.17%, P = .237), and muscle tremors (14.58% vs 8.51%, P = .346), while there were significant differences between 2 groups for intensive care unit stay (6.9 ± 3.4 days vs 12.5 ± 3.5 days, P = .017,), mechanical ventilation time (4.2 ± 1.3 days vs 7.5 ± 2.7 days, P = .034,), CBP time (4.6 ± 1.4 days vs 10.5 ± 4.0 days, P = .019), mortality (12.50% vs 23.40%, P = .024). But the incidence of bradycardia in HT group was much higher than the NT group (29.16% vs 14.89%, P = .029).HT blood purification is a safer and more effective treatment than NT blood purification for patients who suffered from cardiac shock after valve surgery.",2020,blood purification is a safer and more effective treatment than NT blood purification for patients who suffered from cardiac shock after valve surgery.,"['cardiac shock after heart valve disease', 'patients who suffered from cardiac shock after valve surgery', 'Ninety-five patients', 'cardiac shock after valvular disease surgery']","['normothermic (NT) continuous blood purification (CBP) group (NT group) and HT CBP', 'HT', 'sub-hypothermia (HT) blood purification technique', 'sub-hypothermia blood purification technique']","['APACHE III score', 'infection ratio', 'DO2/VO2 ratio', 'blood loss', 'cardiac index (CI), the oxygen delivery (DO2) and oxygen consumption (VO2) ratio, Acute Physiology and Chronic Health Evaluation III(APACHE III) score, multiple organ dysfunction syndrome (MODS) score, dynamic monitoring of electrocardiograph, blood loss with or without muscle tremors, intensive care unit stay, mechanical ventilation time, CBP time, and the cases of infection and mortality', 'MODS score', 'CI, DO2/VO2 ratio, APACHE III score, MODS score', 'mechanical ventilation time', 'incidence of bradycardia', 'CBP time', 'operative cardiac function, cardiothoracic ratio, and type of valve replacement', 'intensive care unit stay', 'muscle tremors', 'incidence of ventricular arrhythmia', 'mortality']","[{'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0018824', 'cui_str': 'Valvular Heart Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0445103', 'cui_str': 'Normothermia (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0243114', 'cui_str': 'purification'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0301039', 'cui_str': '1-Chloro-3-bromopropene-1 (substance)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0243029', 'cui_str': 'APACHE III'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1701256', 'cui_str': 'bis(acetylacetonato)oxovanadium(IV)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index (observable entity)'}, {'cui': 'C0429622', 'cui_str': 'Oxygen delivery (observable entity)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0243030', 'cui_str': 'Acute Physiology and Chronic Health Evaluation'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0026766', 'cui_str': 'Organ Dysfunction Syndrome, Multiple'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0180600', 'cui_str': 'Electrocardiograph'}, {'cui': 'C0235082', 'cui_str': 'Tremor, Muscle'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0301039', 'cui_str': '1-Chloro-3-bromopropene-1 (substance)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C2363738', 'cui_str': 'Cardiothoracic ratio'}, {'cui': 'C0449533', 'cui_str': 'Type of valve (attribute)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia (disorder)'}]",,0.0506014,blood purification is a safer and more effective treatment than NT blood purification for patients who suffered from cardiac shock after valve surgery.,"[{'ForeName': 'Jihui', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Department of Cardiac Surgery.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiac Surgery.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Department of Intensive Care Unit, Wuhan Asia Heart Hospital, Wuhan.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiac Surgery.'}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Ren', 'Affiliation': 'Department of Intensive Care Unit, Wuhan Asia Heart Hospital, Wuhan.'}, {'ForeName': 'Haitao', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Urinary Surgery, Dongfeng Maojian Hospital, Shiyan.'}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Department of Cardiology, Wuhan Asia Heart Hospital.'}, {'ForeName': 'Laichun', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'Department of Cardiac Surgery.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Xiao', 'Affiliation': 'Department of Intensive Care Unit, Asia Heart Hospital, Wuhan University of Science and Technology, Hankou District, Wuhan, P.R. China.'}]",Medicine,['10.1097/MD.0000000000019476']
455,32221084,Traditional Chinese medicine combined with conventional therapy for female kidney stone: A protocol for systematic review.,"INTRODUCTION


Kidney stone is caused by abnormal accumulation of crystalline substances in the kidneys. Kidney stone is one of the urinary system diseases with a high incidence. In this study, we will use the research method of randomized controlled trials to explore the effects of Traditional Chinese medicine combined with western medicine on renal function and urine metabolism in women with kidney stones. We hope that the results of this study will provide more evidence-based medical evidence for TCM to treat kidney stones, and also provide patients with more treatment options.
METHODS/DESIGN


This pragmatic randomized controlled trial will recruit 100 patients who are diagnosed with kidney stone. Simple randomization to conventional drug treatment with a 1:1 allocation ratio will be used. The participants will continue to receive ESWL treatment and TCM therapy. The selection of outcomes will be evaluated by the overall effectiveness of clinical efficacy.
DISCUSSION


This trial may provide evidence regarding the clinical effectiveness, safety, and cost-effectiveness of Traditional Chinese medicine for patients with Female kidney stone.",2020,"This trial may provide evidence regarding the clinical effectiveness, safety, and cost-effectiveness of Traditional Chinese medicine for patients with Female kidney stone.","['women with kidney stones', 'female kidney stone', '100 patients who are diagnosed with kidney stone', 'patients with Female kidney stone']","['Traditional Chinese medicine', 'Traditional Chinese medicine combined with western medicine', 'TCM', 'ESWL treatment and TCM therapy', 'Traditional Chinese medicine combined with conventional therapy']",['renal function and urine metabolism'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0022650', 'cui_str': 'Kidney Stones'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0025124', 'cui_str': 'Zhong Yi Xue'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0042037'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}]",100.0,0.185325,"This trial may provide evidence regarding the clinical effectiveness, safety, and cost-effectiveness of Traditional Chinese medicine for patients with Female kidney stone.","[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Du', 'Affiliation': 'The Second Affiliated Hospital of Shaanxi University of Chinese Medicine, Xianyang, Shaanxi.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lei', 'Affiliation': 'The Second Affiliated Hospital of Shaanxi University of Chinese Medicine, Xianyang, Shaanxi.'}, {'ForeName': 'A-Ni', 'Initials': 'AN', 'LastName': 'Gao', 'Affiliation': 'The Second Affiliated Hospital of Shaanxi University of Chinese Medicine, Xianyang, Shaanxi.'}, {'ForeName': 'Xiao-Min', 'Initials': 'XM', 'LastName': 'Sun', 'Affiliation': 'The Second Affiliated Hospital of Shaanxi University of Chinese Medicine, Xianyang, Shaanxi.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Song', 'Affiliation': 'The Second Affiliated Hospital of Shaanxi University of Chinese Medicine, Xianyang, Shaanxi.'}, {'ForeName': 'Xu-Dong', 'Initials': 'XD', 'LastName': 'Yu', 'Affiliation': 'Graduate School of Beijing University of Chinese Medicine.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Deng', 'Affiliation': 'Graduate School of Beijing University of Chinese Medicine.'}, {'ForeName': 'Hong-Mei', 'Initials': 'HM', 'LastName': 'Si', 'Affiliation': 'Graduate School of Beijing University of Chinese Medicine.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'The Second Affiliated Hospital of Shaanxi University of Chinese Medicine, Xianyang, Shaanxi.'}]",Medicine,['10.1097/MD.0000000000019611']
456,32044802,Subomohyoid Anterior Suprascapular Block versus Interscalene Block for Arthroscopic Shoulder Surgery: A Multicenter Randomized Trial.,"BACKGROUND


Interscalene brachial plexus block, the pain relief standard for shoulder surgery, is an invasive technique associated with important complications. The subomohyoid anterior suprascapular block is a potential alternative, but evidence of its comparative analgesic effect is sparse. The authors tested the hypothesis that anterior suprascapular block is noninferior to interscalene block for improving pain control after shoulder surgery. As a secondary objective, the authors evaluated the success of superior trunk (C5-C6 dermatomes) block with suprascapular block.
METHODS


In this multicenter double-blind noninferiority randomized trial, 140 patients undergoing shoulder surgery were randomized to either interscalene or anterior suprascapular block with 15 ml of ropivacaine 0.5% and epinephrine. The primary outcome was area under the curve of postoperative visual analog scale pain scores during the first 24 h postoperatively. The 90% CI for the difference (interscalene-suprascapular) was compared against a -4.4-U noninferiority margin. Secondary outcomes included presence of superior trunk blockade, pain scores at individual time points, opioid consumption, time to first analgesic request, opioid-related side-effects, and quality of recovery.
RESULTS


A total of 136 patients were included in the analysis. The mean difference (90% CI) in area under the curve of pain scores for the (interscalene-suprascapular) comparison was -0.3 U (-0.8 to 0.12), exceeding the noninferiority margin of -4.4 U and demonstrating noninferiority of suprascapular block. The risk ratio (95% CI) of combined superior trunk (C5-C6 dermatomes) blockade was 0.98 (0.92 to 1.01), excluding any meaningful difference in superior trunk block success rates between the two groups. When differences in other analgesic outcomes existed, they were not clinically important.
CONCLUSIONS


The suprascapular block was noninferior to interscalene block with respect to improvement of postoperative pain control, and also for blockade of the superior trunk. These findings suggest that the suprascapular block consistently blocks the superior trunk and qualify it as an effective interscalene block alternative.",2020,"The suprascapular block was noninferior to interscalene block with respect to improvement of postoperative pain control, and also for blockade of the superior trunk.","['Arthroscopic Shoulder Surgery', '140 patients undergoing shoulder surgery', 'A total of 136 patients were included in the analysis']","['Subomohyoid Anterior Suprascapular Block versus Interscalene Block', 'interscalene or anterior suprascapular block with 15 ml of ropivacaine 0.5% and epinephrine']","['superior trunk block success rates', 'presence of superior trunk blockade, pain scores at individual time points, opioid consumption, time to first analgesic request, opioid-related side-effects, and quality of recovery', 'area under the curve of postoperative visual analog scale pain scores', 'pain scores', 'risk ratio']","[{'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach (procedure)'}, {'cui': 'C0589495', 'cui_str': 'Interscalene approach (qualifier value)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested (finding)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score (observable entity)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}]",140.0,0.219577,"The suprascapular block was noninferior to interscalene block with respect to improvement of postoperative pain control, and also for blockade of the superior trunk.","[{'ForeName': 'Faraj W', 'Initials': 'FW', 'LastName': 'Abdallah', 'Affiliation': ""From the Department of Anesthesiology and Pain Medicine, and the Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Canada (F.W.A.) the Department of Anesthesia (F.W.A., D.N.W., R.B., A.M., V.W.S.C.) the Institute of Health Policy, Management, and Evaluation (D.N.W., A.L.) the Department of Medicine (A.L.) the Dalla Lana School of Public Health (K.E.T.), University of Toronto, Toronto, Canada the Li Ka Shing Knowledge Institute of St. Michael's Hospital, University of Toronto, Toronto, Canada (F.W.A., D.N.W., A.L.) the Department of Anesthesia (D.N.W.) the Department of Medicine (A.L.), St. Michael's Hospital, Toronto, Canada the Department of Anesthesia and Pain Management, University Health Network, Toronto, Canada (D.N.W., V.W.S.C.) the Department of Anesthesia, Women's College Hospital, Toronto, Canada (R.B.) the Department of Anesthesia, North York General Hospital, Toronto, Canada (A.M.) the Department of Anesthesia, Wexner Medical Center, Ohio State University, Columbus, Ohio (N.H.) the Applied Health Research Centre, Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Canada (K.E.T.).""}, {'ForeName': 'Duminda N', 'Initials': 'DN', 'LastName': 'Wijeysundera', 'Affiliation': ''}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Laupacis', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Brull', 'Affiliation': ''}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Mocon', 'Affiliation': ''}, {'ForeName': 'Nasir', 'Initials': 'N', 'LastName': 'Hussain', 'Affiliation': ''}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Thorpe', 'Affiliation': ''}, {'ForeName': 'Vincent W S', 'Initials': 'VWS', 'LastName': 'Chan', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003132']
457,31538907,Effect of Curcumin on Serum Cathepsin D in Patients with Metabolic Syndrome.,"BACKGROUND


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


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


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


The present results do not suggest any effect of curcumin on cathepsin D levels in patients with MetS.",2020,"There were no significant differences between treatment and control groups in regard to weight, BMI, waist circumference and serum cathepsin D levels before and after the intervention.","['A total of 80 participants', '18-65 years old individuals with MetS according to the criteria of &quot;IDF&quot; guidelines', 'Patients with Metabolic Syndrome', 'patients with MetS']","['Curcumin', 'Cathepsin D', 'curcumin', '2 capsules containing 500mg of phosphatidylcholine complex of curcumin, and the other group (n=40) were given two 500mg capsules contain lactose as placebo']","['serum cathepsin D', 'Serum cathepsin D', 'weight, BMI, waist circumference and serum cathepsin D levels', 'anthropometric indices and blood pressure', 'cathepsin D level', 'Serum Cathepsin D']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}]","[{'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0007427', 'cui_str': 'Cathepsin D (substance)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C1959616', 'cui_str': 'Phosphatidyl Cholines'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0022949', 'cui_str': 'Lactose'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0007427', 'cui_str': 'Cathepsin D (substance)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",80.0,0.0224018,"There were no significant differences between treatment and control groups in regard to weight, BMI, waist circumference and serum cathepsin D levels before and after the intervention.","[{'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Shirmohammadi', 'Affiliation': 'School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Ghayour-Mobarhan', 'Affiliation': 'Metabolic Syndrome Research Center, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Saberi-Karimian', 'Affiliation': 'Student Research Committee, Iranian UNESCO Center of Excellence for Human Nutrition, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Iranshahi', 'Affiliation': 'Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Tavallaie', 'Affiliation': 'Metabolic Syndrome Research Center, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Emamian', 'Affiliation': 'Metabolic Syndrome Research Center, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Amirhossein', 'Initials': 'A', 'LastName': 'Sahebkar', 'Affiliation': 'Halal Research Center of IRI, FDA, Tehran, Iran.'}]",Cardiovascular & hematological disorders drug targets,['10.2174/1871529X19666190919110652']
458,30822774,"Randomized, double-blind, placebo-controlled study of F17464, a preferential D 3  antagonist, in the treatment of acute exacerbation of schizophrenia.","F17464, a highly potent preferential D3 antagonist, is a novel compound in development for schizophrenia treatment. This phase II, double-blind, randomized, placebo-controlled, parallel-group study in five European countries evaluated the efficacy and safety of F17464, 20 mg twice daily, versus placebo over 6 weeks in patients with acute exacerbation of schizophrenia. Change from baseline to Day 43 of the Positive and Negative Syndrome Scale (PANSS) total score was the primary outcome. The data from 134 randomized patients (67 per group) were analyzed (efficacy/safety). Using analysis of covariance (ANCOVA) after last observation carried forward (LOCF) imputation (primary analysis), the PANSS total score reduction was statistically significantly greater for F17464 than placebo treated subjects at endpoint (p = 0.014); using ANCOVA with Multiple Imputation (MI) method, the between-group difference was in favor of F17464 but did not reach statistical significance. Differences in PANSS positive and general psychopathology subscale score, Marder positive factor score, PANSS response, and PANSS resolution criteria were also statistically significant in favor of F17464 (p values < 0.05) using the LOCF method, with similar results as for the primary analysis using the MI method. Treatment-related adverse events (AEs) were reported in 49.3% and 46.3% of patients on F17464 and placebo, respectively. The most common AEs in F17464 group: insomnia, agitation, and increased triglycerides; worsening of schizophrenia/drug ineffective was less frequent in F17464. Interestingly, no weight gain, no extrapyramidal disorder except rare akathisia were observed under F17464. This 6-week trial demonstrated therapeutic efficacy of 40 mg/day F17464 in improving symptoms of acute exacerbation of schizophrenia with a favorable safety profile.",2019,"Interestingly, no weight gain, no extrapyramidal disorder except rare akathisia were observed under F17464.","['acute exacerbation of schizophrenia', 'patients with acute exacerbation of schizophrenia']",['placebo'],"['weight gain, no extrapyramidal disorder except rare akathisia', 'insomnia, agitation, and increased triglycerides; worsening of schizophrenia/drug ineffective', 'PANSS positive and general psychopathology subscale score, Marder positive factor score, PANSS response, and PANSS resolution criteria', 'adverse events (AEs', 'PANSS total score reduction', 'therapeutic efficacy', 'Positive and Negative Syndrome Scale (PANSS) total score']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0015371', 'cui_str': 'Extrapyramidal Disorders'}, {'cui': 'C0522498', 'cui_str': 'Uncommon (qualifier value)'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0852908', 'cui_str': 'Drug ineffective'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}]",134.0,0.307203,"Interestingly, no weight gain, no extrapyramidal disorder except rare akathisia were observed under F17464.","[{'ForeName': 'Istvan', 'Initials': 'I', 'LastName': 'Bitter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Semmelweis University, Balassa u.6, Budapest, 1083, Hungary.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Lieberman', 'Affiliation': 'New York Presbyterian Hospital - Columbia University Medical Center, 1051 Riverside Drive, New York, NY, 10032, USA.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Gaudoux', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Sokoloff', 'Affiliation': 'PSAdvice, Impasse Larosa, Ile-aux-Moines, 56780, France.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Groc', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Chavda', 'Affiliation': ""Galderma, Rue D'Entre-deux-Villes 10, La Tour de Peilz, 1814, Switzerland.""}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Delsol', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Barthe', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Brunner', 'Affiliation': 'IRIS Servier, 50 rue Carot, Suresnes Cedex, 92284, France.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Fabre', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Fagard', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Montagne', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Tonner', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France. francoise.tonner@pierre-fabre.com.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0355-2']
459,32032692,"Efficacy and safety of apremilast in patients with moderate to severe plaque psoriasis of the scalp: Results of a phase 3b, multicenter, randomized, placebo-controlled, double-blind study.","BACKGROUND


Many patients with psoriasis are bothered by symptoms in highly visible, pruritic areas, such as the scalp.
OBJECTIVE


To evaluate the efficacy and safety of apremilast for moderate to severe scalp psoriasis.
METHODS


This phase 3b, double-blind, placebo-controlled study randomized adults with moderate to severe scalp psoriasis who had inadequate response/intolerance to at least 1 topical scalp psoriasis therapy (NCT03123471). The primary endpoint was the proportion of patients who achieved Scalp Physician Global Assessment response, defined as score of 0 (clear) or 1 (almost clear), with at least a 2-point reduction, at week 16. Secondary endpoints included at least a 4-point improvement from baseline in Whole Body Itch and Scalp Itch Numeric Rating Scales (NRSs) and mean improvement in Dermatology Life Quality Index (DLQI) at week 16.
RESULTS


There were 303 randomized patients (placebo: n = 102; apremilast: n = 201). With apremilast, significantly more patients achieved Scalp Physician Global Assessment (43.3% vs 13.7%), Scalp Itch NRS (47.1% vs 21.1%), and Whole Body Itch NRS (45.5% vs 22.5%) response, and significantly greater DLQI improvement was observed versus placebo (-6.7 vs -3.8; all P < .0001). Common adverse events with apremilast were diarrhea (30.5%), nausea (21.5%), headache (12.0%), and vomiting (5.5%).
LIMITATIONS


Patients with mild disease were not enrolled.
CONCLUSION


Apremilast showed efficacy for the treatment of moderate to severe scalp psoriasis.",2020,"With apremilast, significantly more patients achieved ScPGA (43.3% vs. 13.7%), Scalp Itch NRS (47.1% vs. 21.1%), and Whole Body Itch NRS (45.5% vs. 22.5%) response, and significantly greater DLQI improvement was observed versus placebo (-6.7 vs. -3.8; all P<0.0001).","['Patients With Moderate to Severe Plaque Psoriasis of the Scalp', 'Patients with mild disease were not enrolled', 'adults with moderate to severe scalp psoriasis who had inadequate response/intolerance to ≥1 topical scalp psoriasis therapy (NCT03123471', '303 randomized patients']","['Placebo', 'placebo']","['Whole Body Itch NRS', 'Scalp Itch NRS', 'diarrhea', 'ScPGA', 'DLQI improvement', '≥4-point improvement from baseline in Whole Body Itch and Scalp Itch numeric rating scales (NRS) and mean improvement in Dermatology Life Quality Index (DLQI', 'Efficacy and Safety', 'nausea', 'vomiting', 'headache', 'proportion of patients who achieved Scalp Physician Global Assessment (ScPGA) response, defined as score of 0 (clear) or 1 (almost clear) with ≥2-point reduction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C0036270', 'cui_str': 'Scalp'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0406326', 'cui_str': 'Scalp psoriasis (disorder)'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0036270', 'cui_str': 'Scalp'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0222045'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index (assessment scale)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",303.0,0.257899,"With apremilast, significantly more patients achieved ScPGA (43.3% vs. 13.7%), Scalp Itch NRS (47.1% vs. 21.1%), and Whole Body Itch NRS (45.5% vs. 22.5%) response, and significantly greater DLQI improvement was observed versus placebo (-6.7 vs. -3.8; all P<0.0001).","[{'ForeName': 'Abby S', 'Initials': 'AS', 'LastName': 'Van Voorhees', 'Affiliation': 'Eastern Virginia Medical School, Norfolk, Virginia. Electronic address: vanvooas@evms.edu.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Stein Gold', 'Affiliation': 'Henry Ford Health System, West Bloomfield, Missouri.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lebwohl', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Strober', 'Affiliation': 'Yale University, New Haven, Connecticut; Central Connecticut Dermatology, Cromwell, Connecticut.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Lynde', 'Affiliation': 'Lynde Institute for Dermatology, Markham, Ontario, Canada.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Tyring', 'Affiliation': 'Department of Dermatology, Center for Clinical Studies, University of Texas Health Science Center, Houston, Texas.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Cauthen', 'Affiliation': 'MidState Skin Institute, Ocala, Florida.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Sofen', 'Affiliation': 'Dermatology Research Associates, Los Angeles, California.'}, {'ForeName': 'Zuoshun', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Celgene Corporation, Summit, New Jersey.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Paris', 'Affiliation': 'Celgene Corporation, Summit, New Jersey.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Celgene Corporation, Summit, New Jersey.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.01.072']
460,30758329,Effects of cannabidiol on brain excitation and inhibition systems; a randomised placebo-controlled single dose trial during magnetic resonance spectroscopy in adults with and without autism spectrum disorder.,"There is increasing interest in the use of cannabis and its major non-intoxicating component cannabidiol (CBD) as a treatment for mental health and neurodevelopmental disorders, such as autism spectrum disorder (ASD). However, before launching large-scale clinical trials, a better understanding of the effects of CBD on brain would be desirable. Preclinical evidence suggests that one aspect of the polypharmacy of CBD is that it modulates brain excitatory glutamate and inhibitory γ-aminobutyric acid (GABA) levels, including in brain regions linked to ASD, such as the basal ganglia (BG) and the dorsomedial prefrontal cortex (DMPFC). However, differences in glutamate and GABA pathways in ASD mean that the response to CBD in people with and without ASD may be not be the same. To test whether CBD 'shifts' glutamate and GABA levels; and to examine potential differences in this response in ASD, we used magnetic resonance spectroscopy (MRS) to measure glutamate (Glx = glutamate + glutamine) and GABA+ (GABA + macromolecules) levels in 34 healthy men (17 neurotypicals, 17 ASD). Data acquisition commenced 2 h (peak plasma levels) after a single oral dose of 600 mg CBD or placebo. Test sessions were at least 13 days apart. Across groups, CBD increased subcortical, but decreased cortical, Glx. Across regions, CBD increased GABA+ in controls, but decreased GABA+ in ASD; the group difference in change in GABA + in the DMPFC was significant. Thus, CBD modulates glutamate-GABA systems, but prefrontal-GABA systems respond differently in ASD. Our results do not speak to the efficacy of CBD. Future studies should examine the effects of chronic administration on brain and behaviour, and whether acute brain changes predict longer-term response.",2019,"Across regions, CBD increased GABA+ in controls, but decreased GABA+ in ASD; the group difference in change in GABA + in the DMPFC was significant.","['34 healthy men (17 neurotypicals, 17 ASD', 'adults with and without autism spectrum disorder']","['cannabidiol', 'placebo', 'magnetic resonance spectroscopy']",['brain excitation and inhibition systems'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]","[{'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0024487', 'cui_str': 'MR Spectroscopy'}]","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]",34.0,0.128076,"Across regions, CBD increased GABA+ in controls, but decreased GABA+ in ASD; the group difference in change in GABA + in the DMPFC was significant.","[{'ForeName': 'Charlotte Marie', 'Initials': 'CM', 'LastName': 'Pretzsch', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Freyberg', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Bogdan', 'Initials': 'B', 'LastName': 'Voinescu', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lythgoe', 'Affiliation': ""Department of Neuroimaging Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Horder', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Maria Andreina', 'Initials': 'MA', 'LastName': 'Mendez', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wichers', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ajram', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Glynis', 'Initials': 'G', 'LastName': 'Ivin', 'Affiliation': 'South London and Maudsley NHS Foundation Trust Pharmacy, London, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Heasman', 'Affiliation': 'South London and Maudsley NHS Foundation Trust Pharmacy, London, UK.'}, {'ForeName': 'Richard A E', 'Initials': 'RAE', 'LastName': 'Edden', 'Affiliation': 'Russel H Morgan Department of Radiology and Radiological Science, Johns Hopkins Medical Institutions, Baltimore, MD, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': ""Department of Neuroimaging Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Declan G M', 'Initials': 'DGM', 'LastName': 'Murphy', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Daly', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Gráinne M', 'Initials': 'GM', 'LastName': 'McAlonan', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK. grainne.mcalonan@kcl.ac.uk.""}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0333-8']
461,32281816,Effects of a family diabetes self-management education intervention on the patients' supporters.,"INTRODUCTION


Diabetes self-management education (DSME) programs that engage the families of patients with diabetes have shown to be effective in improving diabetes-related outcomes of the patients. The health effects of these ""family models"" of DSME on participating family members are rarely studied. Opportunity exists for the participating family members to benefit from the healthy lifestyle recommendations offered through such programs.
METHOD


Using data from a randomized controlled trial to assess the effect of family DSME compared to standard DSME among Marshallese adults with Type 2 diabetes, this study examined baseline to 12-month changes in A1c, body mass index (BMI), food consumption, and physical activity among participating family members, comparing outcomes of family members based on attended at least 1 (n = 98) versus attended no (n = 44) DSME sessions.
RESULTS


Overall, family member attendance was low. There were no differences in the level of change from baseline to 12 months for A1c, BMI, food consumption, and physical activity between groups. After controlling for attendance and sociodemographic measures, lowering of BMI was the only significant predictor of not having an A1c level indicative of diabetes at 12 months.
DISCUSSION


Future research on family DSME should consider ways to improve family member attendance; have them set their own health improvement goals; and integrate healthy lifestyle education, such as healthy eating and being physically active, along with the DSME core content to create an added benefit of diabetes prevention for participating family members. The limitations of this study and recommendations for future research are provided. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"There were no differences in the level of change from baseline to 12 months for A1c, BMI, food consumption, and physical activity between groups.","[""patients' supporters"", 'Marshallese adults with Type 2 diabetes', 'among participating family members, comparing outcomes of family members based on attended at least 1 (n = 98) versus attended no (n = 44) DSME sessions']","['standard DSME', 'family diabetes self-management education intervention', 'family DSME']","['A1c, BMI, food consumption, and physical activity', 'A1c, body mass index (BMI), food consumption, and physical activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0574386', 'cui_str': 'Marshallese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0207488,"There were no differences in the level of change from baseline to 12 months for A1c, BMI, food consumption, and physical activity between groups.","[{'ForeName': 'Holly C', 'Initials': 'HC', 'LastName': 'Felix', 'Affiliation': 'Fay W. Boozman College of Public Health.'}, {'ForeName': 'M Rachelle', 'Initials': 'MR', 'LastName': 'Narcisse', 'Affiliation': 'Office of Community Health and Research.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Long', 'Affiliation': 'College of Medicine.'}, {'ForeName': 'Pearl A', 'Initials': 'PA', 'LastName': 'McElfish', 'Affiliation': 'College of Medicine.'}]","Families, systems & health : the journal of collaborative family healthcare",['10.1037/fsh0000470']
462,32128957,"Efficacy and safety of once-monthly efpeglenatide in patients with type 2 diabetes: Results of a phase 2 placebo-controlled, 16-week randomized dose-finding study.","AIMS


To determine the optimal dose(s) of once-monthly administration of efpeglenatide, a long-acting glucagon-like peptide-1 receptor agonist (GLP-1RA), in patients with type 2 diabetes (T2D) inadequately controlled on metformin.
MATERIALS AND METHODS


In this phase 2, randomized, placebo-controlled, double-blind trial (NCT02081118), patients were randomized 1:1:1:1 to subcutaneous efpeglenatide (8, 12 or 16 mg once monthly; n = 158) or placebo (n = 51). The 16-week treatment period included a 4-week titration phase with once-weekly efpeglenatide 4 mg, followed by one dose of efpeglenatide 8 mg once monthly and two doses of the assigned once-monthly dose. The primary endpoint was change in glycated haemoglobin (HbA1c) from baseline to week 17.
RESULTS


All efpeglenatide doses significantly reduced HbA1c versus placebo (P < 0.0001 for all). Overall, the least squares mean difference in HbA1c reductions between efpeglenatide and placebo was -7.7 mmol/mol (-0.71%; baseline to week 17). At week 17, a significantly greater proportion of efpeglenatide patients had an HbA1c level <53 mmol/mol (<7%) versus placebo (48.7% vs. 30.6%; P = 0.0320). Significant body weight loss occurred across all efpeglenatide doses (placebo-corrected reduction -2.0 kg [efpeglenatide overall]; P = 0.0003). The safety profile was consistent with GLP-1RAs, with gastrointestinal (GI) disorders being the most common treatment-emergent adverse events. Fluctuations in effects on glucose levels and rates of GI events occurred between peak and trough efpeglenatide concentrations.
CONCLUSIONS


Efpeglenatide once monthly (following once-weekly titration) has significant benefits with regard to HbA1c and weight reduction versus placebo in patients with T2D. Further studies are needed to evaluate the long-term efficacy and safety of efpeglenatide once monthly.",2020,All efpeglenatide doses significantly reduced HbA1c versus placebo (P < 0.0001 for all).,"['patients with type 2 diabetes', 'patients with type 2 diabetes inadequately controlled on']","['metformin', 'subcutaneous efpeglenatide', 'placebo', 'Efpeglenatide QM', 'efpeglenatide, a long-acting glucagon-like peptide-1 receptor agonist (GLP-1 RA', '4-week titration phase with once-weekly (QW) efpeglenatide 4\u2009mg, followed by one dose of efpeglenatide 8\u2009mg QM']","['change in HbA1c', 'Efficacy and safety', 'HbA1c and weight reduction', 'HbA1c reductions', 'Significant body weight loss', 'glucose levels and rates of gastrointestinal events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0558293', 'cui_str': 'Once a week (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",,0.613438,All efpeglenatide doses significantly reduced HbA1c versus placebo (P < 0.0001 for all).,"[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Del Prato', 'Affiliation': 'Department of Endocrinology and Metabolism, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Jahoon', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'Hanmi Pharmaceutical Co., Ltd, Seoul, South Korea.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Trautmann', 'Affiliation': 'ProSciento, Chula Vista, California.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Stewart', 'Affiliation': 'Sanofi Canada, Laval, Quebec, Canada.'}, {'ForeName': 'Christopher H', 'Initials': 'CH', 'LastName': 'Sorli', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Derwahl', 'Affiliation': 'IKFE Berlin GmbH Institute for Clinical Research and Development, Berlin, Germany.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Soto', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Hospital de A Coruña, La Coruña, Spain.'}, {'ForeName': 'Kun-Ho', 'Initials': 'KH', 'LastName': 'Yoon', 'Affiliation': 'The Catholic University of Korea, Seoul, South Korea.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14020']
463,32282432,Subcutaneous Nitroglycerin for Radial Arterial Catheterization in Pediatric Patients: A Randomized Controlled Trial.,"BACKGROUND


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


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


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


Subcutaneous nitroglycerin injection before radial artery cannulation improved the first-attempt success rate and reduced the overall complication rates in pediatric patients.",2020,"The nitroglycerin group had a higher first-attempt success rate than the control group (91.2% [52 of 57] vs. 66.1% [37 of 56]; P = 0.002; odds ratio, 5.3; 95% CI, 1.83 to 15.6; absolute risk reduction, -25.2%; 95% CI, -39.6 to -10.7%).","['Pediatric Patients', 'enrolled pediatric patients (n = 113, age less than 2 yr) requiring radial artery cannulation during general anesthesia', '113 children', 'pediatric patients', 'adult patients']","['Subcutaneous Nitroglycerin', 'nitroglycerin', 'Subcutaneous nitroglycerin', 'normal saline', 'Nitroglycerin', 'nitroglycerin injection', 'nitroglycerin solution']","['success rate of arterial cannulation', 'Radial artery diameter', 'diameter of the radial artery and the overall complication rate including hematoma and vasospasm', 'diameter of the radial artery', 'first-attempt successful cannulation rate', 'higher first-attempt success rate', 'Overall complication rate', 'overall complication rates']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C4307250', 'cui_str': 'Nitroglycerin Injection'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0042396', 'cui_str': 'Vascular constriction'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0205250', 'cui_str': 'High'}]",113.0,0.634855,"The nitroglycerin group had a higher first-attempt success rate than the control group (91.2% [52 of 57] vs. 66.1% [37 of 56]; P = 0.002; odds ratio, 5.3; 95% CI, 1.83 to 15.6; absolute risk reduction, -25.2%; 95% CI, -39.6 to -10.7%).","[{'ForeName': 'Young-Eun', 'Initials': 'YE', 'LastName': 'Jang', 'Affiliation': ""From the Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul, Republic of Korea (Y.-E.J., S.-H.J., E.-H.K., J.-H.L.) the Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea (H.-S.K., J.-T.K.) the Division of Pediatric Cardiovascular Anesthesia, Baylor College of Medicine, Texas Children's Hospital, Houston, Texas (E.B.M.).""}, {'ForeName': 'Sang-Hwan', 'Initials': 'SH', 'LastName': 'Ji', 'Affiliation': ''}, {'ForeName': 'Eun-Hee', 'Initials': 'EH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Ji-Hyun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Hee-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Emad B', 'Initials': 'EB', 'LastName': 'Mossad', 'Affiliation': ''}, {'ForeName': 'Jin-Tae', 'Initials': 'JT', 'LastName': 'Kim', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003308']
464,30901755,Postoperative structured rehabilitation in patients undergoing surgery for cervical radiculopathy: a 2-year follow-up of a randomized controlled trial.,"OBJECTIVE


Information about postoperative rehabilitation for cervical radiculopathy (CR) is scarce. The aim of this study was to investigate the additional benefits of structured postoperative rehabilitation (SPT), which was performed in all patients, compared with a pragmatic standard postoperative approach (SA), in which rehabilitation was used as needed and patients sought physiotherapy on their own without a referral, in patients with MRI evidence of disc herniation and concomitant clinical signs who underwent surgery for CR.
METHODS


Patients (n = 202) were randomized to receive SPT or SA. Included key variables in the present study were primary and selected secondary outcomes of a prospective randomized controlled multicenter study. The main outcome was the Neck Disability Index (NDI) score. The NDI score, pain variables, self-efficacy, and health-related quality of life were investigated at baseline and 3, 6, 12, and 24 months postoperatively.
RESULTS


SPT provided no additional benefits over SA (p = 0.08 to p = 0.99) at the postoperative 2-year follow-up. Both groups improved over time (p < 0.0001), with no reported adverse effects.
CONCLUSIONS


One can conclude that SPT offered no additional benefits over SA; however, patients tolerated postoperative neck exercises without any negative side effects. These findings are important for the development of future active and neck-specific postoperative rehabilitation interventions for patients with CR.Clinical trial registration no.: NCT01547611 (clinicaltrials.gov).",2019,SPT provided no additional benefits over SA (p = 0.08 to p = 0.99) at the postoperative 2-year follow-up.,"['patients undergoing surgery for cervical radiculopathy', 'Patients (n = 202', 'patients with MRI evidence of disc herniation and concomitant clinical signs who underwent surgery for CR']","['Postoperative structured rehabilitation', 'pragmatic standard postoperative approach (SA', 'structured postoperative rehabilitation (SPT', 'SPT', 'SPT or SA']","['adverse effects', 'NDI score, pain variables, self-efficacy, and health-related quality of life', 'tolerated postoperative neck exercises', 'Neck Disability Index (NDI) score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0742186', 'cui_str': 'Radiculopathy, Cervical'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0454347', 'cui_str': 'Neck exercises (regime/therapy)'}, {'cui': 'C2959538', 'cui_str': 'Neck disability index score'}]",202.0,0.266221,SPT provided no additional benefits over SA (p = 0.08 to p = 0.99) at the postoperative 2-year follow-up.,"[{'ForeName': 'Anneli', 'Initials': 'A', 'LastName': 'Peolsson', 'Affiliation': '1Department of Medical and Health Sciences, Physiotherapy, Linköping University, Linköping.'}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Löfgren', 'Affiliation': '2Neuro-Orthopedic Center, Ryhov Hospital, Region Jönköping County, Jönköping.'}, {'ForeName': 'Åsa', 'Initials': 'Å', 'LastName': 'Dedering', 'Affiliation': '3Allied Health Professionals Function, Function Area Occupational Therapy and Physiotherapy, Karolinska University Hospital, Stockholm.'}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Öberg', 'Affiliation': '1Department of Medical and Health Sciences, Physiotherapy, Linköping University, Linköping.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Zsigmond', 'Affiliation': '5Department of Neurosurgery, Linköping University Hospital, Linköping; and.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Hedevik', 'Affiliation': '1Department of Medical and Health Sciences, Physiotherapy, Linköping University, Linköping.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Wibault', 'Affiliation': '1Department of Medical and Health Sciences, Physiotherapy, Linköping University, Linköping.'}]",Journal of neurosurgery. Spine,['10.3171/2018.12.SPINE181258']
465,31407943,Developing a phone-based measure of impairment after acute oral ∆ 9 -tetrahydrocannabinol.,"BACKGROUND


Acute consumption of cannabis or its primary psychoactive ingredient ∆ 9 -tetrahydrocannabinol has been shown to impair memory, reaction time, time perception, and attention. However, it is difficult to measure these impairments in a brief test that can be used in a non-laboratory setting.
AIMS


We aim to develop and validate a prototype for a mobile phone application to measure ∆ 9 -tetrahydrocannabinol-induced cognitive impairment.
METHODS


We conducted two double-blind, within-subjects studies examining impairments after oral doses of ∆ 9 -tetrahydrocannabinol (0, 7.5, 15 mg) using both standardized computer-based tasks and our novel phone-based tasks. The tasks measured cognitive speed, reaction time, fine motor ability, and working memory and, in the second study, time perception. Study 1 ( n =24) provided initial data, and Study 2 ( n =24) was designed to refine the measures. In both studies, healthy non-daily cannabis users participated in three four-hour experimental sessions in which they received capsules containing ∆ 9 -tetrahydrocannabinol (7.5, 15 mg) or placebo. Subjective and cardiovascular measures were obtained at regular intervals, and at the time of peak drug effect subjects completed both standardized, computer-based and brief, phone-based tasks.
RESULTS


∆ 9 -Tetrahydrocannabinol-induced impairment was detected on most of the computer tasks, but was not evident on most of the phone tasks.
CONCLUSIONS


The phone tasks were brief, to facilitate use in a non-laboratory setting, but it is likely that this made them less sensitive to the impairing effects of ∆ 9 -tetrahydrocannabinol. These findings confirm that ∆ 9 -tetrahydrocannabinol impairs performance on several tasks at two recreationally relevant doses, but raises question about the feasibility of designing a phone application as a sensitive field sobriety test for cannabis.",2019,"9 -tetrahydrocannabinol has been shown to impair memory, reaction time, time perception, and attention.",['healthy non-daily cannabis users'],"['placebo', '∆ 9 -tetrahydrocannabinol (0, 7.5, 15 mg) using both standardized computer-based tasks and our novel phone-based tasks']","['Subjective and cardiovascular measures', 'cognitive speed, reaction time, fine motor ability, and working memory and, in the second study, time perception']","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0199659', 'cui_str': 'Cardiovascular measure'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205232', 'cui_str': 'Fine (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0040226', 'cui_str': 'Time Perception'}]",,0.048469,"9 -tetrahydrocannabinol has been shown to impair memory, reaction time, time perception, and attention.","[{'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Pabon', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881119862533']
466,32157772,"A randomized, open-label, active comparator trial assessing the effects of 26 weeks of liraglutide or sitagliptin on cardiovascular function in young obese adults with type 2 diabetes.","AIM


To compare the effects of a glucagon-like peptide-1 receptor agonist and a dipeptidyl peptidase-4 inhibitor on magnetic resonance imaging-derived measures of cardiovascular function.
MATERIALS AND METHODS


In a prospective, randomized, open-label, blinded endpoint trial liraglutide (1.8 mg) and sitagliptin (100 mg) were compared in asymptomatic, non-insulin treated young (aged 18-50 years) adults with obesity and type 2 diabetes. The primary outcome was difference in circumferential peak early diastolic strain rate change (PEDSR), a biomarker of cardiac diastolic dysfunction 26 weeks after randomization. Secondary outcomes included other indices of cardiac structure and function, HbA1c and body weight.
RESULTS


Seventy-six participants were randomized (54% female, mean ± SD age 44 ± 6 years, diabetes duration 4.4 years, body mass index 35.3 ± 6.1 kg m -2  ), of whom 65% had ≥1 cardiovascular risk factor. Sixty-one participants had primary outcome data available. There were no statistically significant between-group differences (intention-to-treat; mean [95% confidence interval]) in PEDSR change (-0.01 [-0.07, +0.06] s -1  ), left ventricular ejection fraction (-1.98 [-4.90, +0.94]%), left ventricular mass (+1.14 [-5.23, +7.50] g) or aortic distensibility (-0.35 [-0.98, +0.28] mmHg -1   × 10 -3  ) after 26 weeks. Reductions in HbA1c (-4.57 [-9.10, -0.37] mmol mol -1  ) and body weight (-3.88 [-5.74, -2.01] kg) were greater with liraglutide.
CONCLUSION


There were no differences in cardiovascular structure or function after short-term use of liraglutide and sitagliptin in younger adults with obesity and type 2 diabetes. Longer studies in patients with more severe cardiac dysfunction may be necessary before definitive conclusions can be made about putative pleiotropic properties of incretin-based therapies.",2020,There were no differences in cardiovascular structure or function after short-term use of liraglutide and sitagliptin in younger adults with obesity and type 2 diabetes.,"['Seventy-six participants were randomised (54% female, mean\u2009±\u2009SD; age 44\u2009±\u20096, diabetes duration 4.4\u2009years, BMI 35.3\u2009±\u20096.1 kgm -2  ) of which 65% had ≥1 cardiovascular risk factor', 'young obese adults with type 2 diabetes', 'younger adults with obesity and type 2 diabetes', 'asymptomatic, non-insulin treated young (18-50\u2009years) adults with obesity and type 2 diabetes']","['liraglutide or sitagliptin', 'sitagliptin', 'GLP-1 receptor analogue and a DPP-4 inhibitor', 'liraglutide', 'liraglutide and sitagliptin']","['cardiovascular structure or function', 'left ventricular mass', 'circumferential peak early-diastolic strain rate change (PEDSR); a biomarker of cardiac diastolic dysfunction', 'left ventricular ejection fraction', 'aortic distensibility', 'indices of cardiac structure and function, HbA1c and body weight', 'HbA1c', 'body weight ', 'cardiovascular function', 'PEDSR change']","[{'cui': 'C4319622', 'cui_str': 'Seventy-six'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0007226', 'cui_str': 'Circulatory System'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass (finding)'}, {'cui': 'C0205113', 'cui_str': 'Circumferential (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0520863', 'cui_str': 'Diastolic dysfunction (finding)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0007227', 'cui_str': 'Cardiovascular Physiology'}]",76.0,0.246854,There were no differences in cardiovascular structure or function after short-term use of liraglutide and sitagliptin in younger adults with obesity and type 2 diabetes.,"[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Webb', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK.'}, {'ForeName': 'Zin Zin', 'Initials': 'ZZ', 'LastName': 'Htike', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Swarbrick', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Glenfield Hospital, Leicester, UK.'}, {'ForeName': 'Emer M', 'Initials': 'EM', 'LastName': 'Brady', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Glenfield Hospital, Leicester, UK.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Gray', 'Affiliation': 'Department of Health Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Biglands', 'Affiliation': 'NIHR Leeds Biomedical Research Centre, Chapel Allerton Hospital, Leeds, UK.'}, {'ForeName': 'Gaurav S', 'Initials': 'GS', 'LastName': 'Gulsin', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Glenfield Hospital, Leicester, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Henson', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK.'}, {'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Khunti', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK.'}, {'ForeName': 'Gerry P', 'Initials': 'GP', 'LastName': 'McCann', 'Affiliation': 'NIHR Leicester Biomedical Research Centre, Leicester General Hospital, Leicester, UK.'}, {'ForeName': 'Helen L', 'Initials': 'HL', 'LastName': 'Waller', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK.'}, {'ForeName': ""M'Balu A"", 'Initials': 'MA', 'LastName': 'Webb', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK.'}, {'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Sargeant', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Yates', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Zaccardi', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK.'}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14023']
467,32115879,Nasal glucagon as a viable alternative for treating insulin-induced hypoglycaemia in Japanese patients with type 1 or type 2 diabetes: A phase 3 randomized crossover study.,"AIM


To compare nasal glucagon (NG) with intramuscular glucagon (IMG) for the treatment of insulin-induced hypoglycaemia in Japanese patients with type 1 (T1DM) or type 2 diabetes mellitus (T2DM).
MATERIALS AND METHODS


This phase 3, randomized, open-label, two-treatment, two-period crossover non-inferiority study enrolled Japanese adults with T1DM or T2DM on insulin therapy, with glycated haemoglobin levels ≤86 mmol/mol (≤10%). After ≥8 hours of fasting, hypoglycaemia was induced with human regular insulin (intravenous infusion). Patients received NG 3 mg or IMG 1 mg approximately 5 minutes after insulin termination. The primary endpoint was the proportion of patients achieving treatment success [plasma glucose (PG) increase to ≥3.9 mmol/L (≥70 mg/dL) or ≥1.1 mmol/L (≥20 mg/dL) increase from the PG nadir within 30 minutes of receiving glucagon]. Non-inferiority was declared if the upper limit of the two-sided 95% confidence interval (CI) of the mean difference in the percentage of patients achieving treatment success (IMG minus NG) was <10%.
RESULTS


Seventy-five patients with T1DM (n = 34) or T2DM (n = 41) were enrolled; 72 patients (50 men, 22 women) received ≥1 study drug dose (T1DM, n = 33; T2DM, n = 39). Sixty-eight patients completed the study and were evaluable. All NG- and IMG-treated patients achieved treatment success (treatment arm difference: 0%; upper limit of two-sided 95% CI 1.47%); NG met prespecified conditions defining non-inferiority versus IMG. Glucagon was rapidly absorbed after both nasal and intramuscular administration; PG profiles were similar between administration routes during the first 60 minutes post dose. Study drug-related treatment-emergent adverse events affecting >2 patients were rhinalgia, increased blood pressure, nausea, ear pain and vomiting in the NG group, and nausea and vomiting in the IMG group.
CONCLUSION


Nasal glucagon was non-inferior to IMG for successful treatment of insulin-induced hypoglycaemia in Japanese patients with T1DM/T2DM, supporting use of NG as a rescue treatment for severe hypoglycaemia.",2020,,['Japanese Patients with Type 1 and Type 2 Diabetes'],['Nasal Glucagon'],[],"[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}]",[],,0.0960908,,"[{'ForeName': 'Munehide', 'Initials': 'M', 'LastName': 'Matsuhisa', 'Affiliation': 'Diabetes Therapeutics and Research Centre, Institute of Advanced Medical Sciences, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Takita', 'Affiliation': 'Medicine Development Unit-Japan and Medical Affairs, Eli Lilly Japan K.K., Kobe, Japan.'}, {'ForeName': 'Risa', 'Initials': 'R', 'LastName': 'Nasu', 'Affiliation': 'Medicine Development Unit-Japan and Medical Affairs, Eli Lilly Japan K.K., Kobe, Japan.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Nagai', 'Affiliation': 'Medicine Development Unit-Japan and Medical Affairs, Eli Lilly Japan K.K., Kobe, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ohwaki', 'Affiliation': 'Medicine Development Unit-Japan and Medical Affairs, Eli Lilly Japan K.K., Kobe, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Nagashima', 'Affiliation': 'Shinjuku Research Park Clinic, Tokyo, Japan.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14019']
468,32282773,Nonaggressive Versus Aggressive Intravenous Fluid Therapy in Acute Pancreatitis With More Than 24 Hours From Disease Onset: A Randomized Controlled Trial.,"OBJECTIVE


This study aimed to compare a ""nonaggressive"" hydration versus an ""aggressive"" hydration using Hartmann's solution in patients with acute pancreatitis (AP) with more than 24 hours from disease onset.
METHODS


We included 88 patients with AP with more than 24 hours from disease onset, and were randomized into 2 groups. Group I (n = 45) received a nonaggressive hydration (Hartmann's solution at 1.5 mL kg h for the first 24 hours and 30 mL kg during the next 24 hours), and group II (n = 43) received an aggressive hydration (bolus of Hartmann's solution 20 mL kg, followed by an infusion of 3 mL kg h for the first 24 hours and then 30 mL kg for the next 24 hours).
RESULTS


The mean volume of fluid administered was greater in group II (P < 0.001). We did not find differences when comparing both groups in reference to persistent systemic inflammatory response syndrome (P = 0.528), pancreatic necrosis (P = 0.710), respiratory complications (P = 0.999), acute kidney injury (P = 0.714), or length of hospital stay (P = 0.892).
CONCLUSIONS


Our study suggests that the clinical evolution of patients with AP with more than 24 hours from disease onset is similar using an aggressive or nonaggressive hydration.",2020,"We did not find differences when comparing both groups in reference to persistent systemic inflammatory response syndrome (P = 0.528), pancreatic necrosis (P = 0.710), respiratory complications (P = 0.999), acute kidney injury (P = 0.714), or length of hospital stay (P = 0.892).
","['Acute Pancreatitis', '88 patients with AP with more than 24 hours from disease onset', 'patients with acute pancreatitis (AP) with more than 24 hours from disease onset', 'With More Than 24 Hours From Disease Onset']","['nonaggressive"" hydration versus an ""aggressive"" hydration using Hartmann\'s solution', ""aggressive hydration (bolus of Hartmann's solution"", ""nonaggressive hydration (Hartmann's solution"", 'Nonaggressive Versus Aggressive Intravenous Fluid Therapy']","['mean volume of fluid administered', 'length of hospital stay', 'pancreatic necrosis', 'acute kidney injury', 'systemic inflammatory response syndrome', 'respiratory complications']","[{'cui': 'C0001339', 'cui_str': 'Acute pancreatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0277793', 'cui_str': 'Onset of illness'}]","[{'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0073385', 'cui_str': ""Lactated Ringer's Solution""}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0267941', 'cui_str': 'Acute necrotizing pancreatitis'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0242966', 'cui_str': 'Systemic inflammatory response syndrome'}, {'cui': 'C0161818', 'cui_str': 'Respiratory complication'}]",88.0,0.335232,"We did not find differences when comparing both groups in reference to persistent systemic inflammatory response syndrome (P = 0.528), pancreatic necrosis (P = 0.710), respiratory complications (P = 0.999), acute kidney injury (P = 0.714), or length of hospital stay (P = 0.892).
","[{'ForeName': 'Jesús Eduardo', 'Initials': 'JE', 'LastName': 'Cuéllar-Monterrubio', 'Affiliation': 'From the Servicio de Gastroenterología, Hospital Universitario ""Dr. José Eleuterio González,"" Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, México.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Monreal-Robles', 'Affiliation': ''}, {'ForeName': 'Emmanuel I', 'Initials': 'EI', 'LastName': 'González-Moreno', 'Affiliation': ''}, {'ForeName': 'Omar D', 'Initials': 'OD', 'LastName': 'Borjas-Almaguer', 'Affiliation': ''}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Herrera-Elizondo', 'Affiliation': ''}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'García-Compean', 'Affiliation': ''}, {'ForeName': 'Héctor J', 'Initials': 'HJ', 'LastName': 'Maldonado-Garza', 'Affiliation': ''}, {'ForeName': 'José Alberto', 'Initials': 'JA', 'LastName': 'González-González', 'Affiliation': ''}]",Pancreas,['10.1097/MPA.0000000000001528']
469,31524836,Prehospital plasma in injured patients is associated with survival principally in blunt injury: Results from two randomized prehospital plasma trials.,"INTRODUCTION


Recent evidence demonstrated that prehospital plasma in patients at risk of hemorrhagic shock was safe for ground transport and resulted in a 28-day survival benefit for air medical transport patients. Whether any beneficial effect of prehospital plasma varies across injury mechanism remains unknown.
METHODS


We performed a secondary analysis using a harmonized data set derived from two recent prehospital plasma randomized trials. Identical inclusion/exclusion criteria and primary/secondary outcomes were used for the trials. Prehospital time, arrival shock parameters, and 24-hour transfusion requirements were compared across plasma and control groups stratified by mechanism of injury. Stratified survival analysis and Cox hazard regression were performed to determine the independent survival benefits of plasma across blunt and penetrating injury.
RESULTS


Blunt patients had higher injury severity, were older, and had a lower Glasgow Coma Scale. Arrival indices of shock and coagulation parameters were similar across blunt and penetrating injury. The percentage of patients with a prehospital time less than 20 minutes was significantly higher for penetrating patients relative to blunt injured patients (28.0% vs. 11.6%, p < 0.01). Stratified Kaplan-Meier curves demonstrated a significant separation for blunt injured patients (n = 465, p = 0.01) with no separation demonstrated for penetrating injured patients (n = 161, p = 0.60) Stratified Cox hazard regression verified, after controlling for all important confounders, that prehospital plasma was associated with a 32% lower independent hazard for 28-day mortality in blunt injured patients (hazard ratio, 0.68; 95% confidence interval, 0.47-0.96; p = 0.03) with no independent survival benefit found in penetrating patients (hazard ratio, 1.16; 95% confidence interval, 0.4-3.1; p = 0.78).
CONCLUSION


A survival benefit associated with prehospital plasma at 24 hours and 28 days exists primarily in blunt injured patients with no benefit shown in penetrating trauma patients. No detrimental effects attributable to plasma are demonstrated in penetrating injury. These results have important relevance to military and civilian trauma systems.
LEVEL OF EVIDENCE


Therapeutic, I.",2020,"Prehospital time, arrival shock parameters and 24-hour transfusion requirements were compared across plasma and control groups stratified by mechanism of injury.",['IS ASSOCIATED WITH SURVIVAL PRINCIPALLY IN BLUNT INJURY'],[],"['Prehospital time, arrival shock parameters and 24-hour transfusion requirements', 'Arrival indices of shock and coagulation parameters', 'percentage of patients with a prehospital time less', 'survival benefit']","[{'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0043253', 'cui_str': 'Injuries, Nonpenetrating'}]",[],"[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.41386,"Prehospital time, arrival shock parameters and 24-hour transfusion requirements were compared across plasma and control groups stratified by mechanism of injury.","[{'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Reitz', 'Affiliation': 'From the Department of Surgery (K.M.R., A.H., J.B.B., B.S.Z., M.D.N., J.L.S.), University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Surgery (H.B.M., A.S., E.E.M., M.P.C.), University of Colorado and Denver Health Medical Center, Denver, Colorado; Department of Emergency Medicine (F.X.G.), University of Pittsburgh, Pittsburgh, Pennsylvania; US Army Institute of Surgical Research (A.E.P.), JBSA Fort Sam Houston, San Antonio, Texas; Department of Surgery (B.J.D.), University of Tennessee Health Science Center, Knoxville; Department of Surgery (R.S.M.), Vanderbilt University Medical Center, Nashville, Tennessee; University of Louisville (B.G.H.), Louisville, Kentucky; MetroHealth Medical Center (J.A.C.), Case Western Reserve University, Cleveland, Ohio; Department of Surgery (H.A.P.), University of Texas Southwestern, Parkland Memorial Hospital, Dallas, Texas; Department of Pathology (M.H.Y.), University of Pittsburgh and Institute for Transfusion Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Hunter B', 'Initials': 'HB', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'Frank X', 'Initials': 'FX', 'LastName': 'Guyette', 'Affiliation': ''}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Sauaia', 'Affiliation': ''}, {'ForeName': 'Anthony E', 'Initials': 'AE', 'LastName': 'Pusateri', 'Affiliation': ''}, {'ForeName': 'Ernest E', 'Initials': 'EE', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Hassoune', 'Affiliation': ''}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Chapman', 'Affiliation': ''}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Daley', 'Affiliation': ''}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Miller', 'Affiliation': ''}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Harbrecht', 'Affiliation': ''}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Claridge', 'Affiliation': ''}, {'ForeName': 'Herb A', 'Initials': 'HA', 'LastName': 'Phelan', 'Affiliation': ''}, {'ForeName': 'Joshua B', 'Initials': 'JB', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Zuckerbraun', 'Affiliation': ''}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Neal', 'Affiliation': ''}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Yazer', 'Affiliation': ''}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Sperry', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002485']
470,31800559,Comparison of Nd: YAG Laser and Combined Intense Pulsed Light and Radiofrequency in the Treatment of Hypertrophic Scars: A Prospective Clinico-Histopathological Study.,"INTRODUCTION


Hypertrophic scars are fibroproliferative disorders, seen after burn, trauma, and/or surgery. We aimed to compare the clinical and histopathological results of 1064-nm Nd:YAG laser and combined intense pulsed light and radiofrequency in the treatment of hypertrophic scars.
METHODS


Fifty patients with hypertrophic scars were included in this prospective, randomized study. Twenty-five patients were treated with Nd:YAG laser and 25 patients with combined intense pulsed light and radiofrequency (E-light). The scars were evaluated at baseline, during and at 3 months after the final treatment session using the Vancouver scar scale. Biopsy specimens from scars were obtained before, during, and 3 months after the final treatment session and were stained with hematoxylin and eosin stain, Masson's trichrome stain, and immunostaining procedures for collagen I, collagen III, and TGF-β1.
RESULTS


Significant improvements in the total Vancouver scar scale scores before and after the treatment in both groups (P < 0.001); however, a significant difference between both groups (P < 0.001), regarding the E-light, which showed better response than Nd:YAG laser. Hematoxylin and eosin and Masson's trichrome staining showed arrangement and thinning of collagen bundles and reduction in collagen density by in both groups, but the collagen bundles thinning and parallelism were more obvious in the E-light group. Significant decrease in the concentration of collagen I, collagen III, and TGF-β1 in the E-light group as compared with the laser group (P = 0.005, P = 0.003 and P < 0.001, respectively).
CONCLUSIONS


Both modalities were successful in the treatment of hypertrophic scars; however, a significant improvement in the clinical and histopathological findings was detected with the E-light method.",2020,Significant decrease in the concentration of collagen,"['and 25 patients with', 'Fifty patients with hypertrophic scars', 'Hypertrophic Scars']","['combined intense pulsed light and radiofrequency (E-light', '1064-nm Nd:YAG laser and combined intense pulsed light and radiofrequency', 'Nd:YAG laser', ""hematoxylin and eosin stain, Masson's trichrome stain, and immunostaining procedures for collagen"", 'Nd: YAG Laser and Combined Intense Pulsed Light and Radiofrequency']","['collagen density', 'concentration of collagen', 'total Vancouver scar scale scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162810', 'cui_str': 'Scars, Hypertrophic'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0587723', 'cui_str': 'Lasers, Yttrium Aluminum Garnet'}, {'cui': 'C0523207', 'cui_str': 'Hematoxylin and eosin stain'}, {'cui': 'C1294297', 'cui_str': 'Masson trichrome stain'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}]","[{'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",50.0,0.0180961,Significant decrease in the concentration of collagen,"[{'ForeName': 'Mohamed M', 'Initials': 'MM', 'LastName': 'Khedr', 'Affiliation': 'From the Plastic Surgery Department.'}, {'ForeName': 'Wael Hussein', 'Initials': 'WH', 'LastName': 'Mahmoud', 'Affiliation': 'From the Plastic Surgery Department.'}, {'ForeName': 'Fersan A', 'Initials': 'FA', 'LastName': 'Sallam', 'Affiliation': 'Pathology Department, Tanta Faculty of Medicine, Tanta, Egypt.'}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Elmelegy', 'Affiliation': 'From the Plastic Surgery Department.'}]",Annals of plastic surgery,['10.1097/SAP.0000000000002086']
471,31707107,Neurofeedback impacts cognition and quality of life in pediatric focal epilepsy: An exploratory randomized double-blinded sham-controlled trial.,"OBJECTIVE


Children with epilepsy experience cognitive deficits and well-being issues that have detrimental effects on their development. Pharmacotherapy is the standard of care in epilepsy; however, few interventions exist to promote cognitive development and to mitigate disease burden. We aimed to examine the impact of two different modalities of neurofeedback (NFB) on cognitive functioning and quality-of-life (QOL) measurements in children and adolescents with controlled focal epilepsy. The study also explored the effects of NFB on clinical outcomes and electroencephalography (EEG) quantitative analysis.
METHODS


Participants (n = 44) with controlled focal epilepsy were randomized to one of three arms: sensorimotor rhythm (SMR) NFB (n = 15), slow cortical potentials (SCP) NFB (n = 16), or sham NFB (n = 13). All participants received 25 sessions of intervention. The attention switching task (AST), Liverpool Seizure Severity Scale (LSSS), seizure frequency (SF), EEG power spectrum, and coherence were measured at baseline, postintervention, and at 3-month follow-up.
RESULTS


In children and adolescents with controlled focal epilepsy, SMR training significantly reduced reaction time in the AST (p = 0.006), and this was correlated with the difference of change for theta power on EEG (p = 0.03); only the SMR group showed a significant decrease in beta coherence (p = 0.03). All groups exhibited improvement in QOL (p = <0.05).
CONCLUSIONS


This study provides the first data on two NFB modalities (SMR and SCP) including cognitive, neurophysiological, and clinical outcomes in pediatric epilepsy. Sensorimotor rhythm NFB improved cognitive functioning, while all the interventions showed improvements in QOL, demonstrating a powerful placebo effect in the sham group.",2019,"All groups exhibited improvement in QOL (p = <0.05).
","['pediatric focal epilepsy', 'Participants (n\u202f=\u202f44) with controlled focal epilepsy', 'Children with epilepsy experience cognitive deficits', 'pediatric epilepsy', 'children and adolescents with controlled focal epilepsy']","['neurofeedback (NFB', 'Pharmacotherapy', 'NFB modalities (SMR and SCP', 'NFB', 'sensorimotor rhythm (SMR) NFB (n\u202f=\u202f15), slow cortical potentials (SCP) NFB (n\u202f=\u202f16), or sham NFB']","['reaction time', 'clinical outcomes and electroencephalography (EEG) quantitative analysis', 'Neurofeedback impacts cognition and quality of life', 'cognitive functioning', 'beta coherence', 'QOL', 'cognitive functioning and quality-of-life (QOL) measurements', 'attention switching task (AST), Liverpool Seizure Severity Scale (LSSS), seizure frequency (SF), EEG power spectrum, and coherence']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0014547', 'cui_str': 'Focal Seizure Disorder'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0034380'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",,0.331688,"All groups exhibited improvement in QOL (p = <0.05).
","[{'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Morales-Quezada', 'Affiliation': 'Neuromodulation Center, Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Charlestown, MA, USA. Electronic address: jmorales-quezada@partners.org.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Martinez', 'Affiliation': 'Boston Neurodynamics, Brookline, MA, USA; Neocemod, Centro de Neuromodulacion, Aguascalientes, Mexico.'}, {'ForeName': 'Mirret M', 'Initials': 'MM', 'LastName': 'El-Hagrassy', 'Affiliation': 'Neuromodulation Center, Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Charlestown, MA, USA.'}, {'ForeName': 'Ted J', 'Initials': 'TJ', 'LastName': 'Kaptchuk', 'Affiliation': 'Program in Placebo Studies and Therapeutic Encounter, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'M Barry', 'Initials': 'MB', 'LastName': 'Sterman', 'Affiliation': 'Department of Neurobiology, UCLA School of Medicine, USA; Department of Biobehavioral Psychiatry, UCLA School of Medicine, USA.'}, {'ForeName': 'Gloria Y', 'Initials': 'GY', 'LastName': 'Yeh', 'Affiliation': ""Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA; Osher Center for Integrative Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2019.106570']
472,31763491,Rationale and design of an international randomized placebo-controlled trial of a 36-ingredient micronutrient supplement for children with ADHD and irritable mood: The Micronutrients for ADHD in Youth (MADDY) study.,"Background


Attention-Deficit/Hyperactivity Disorder (ADHD) is a chronic neurodevelopmental disorder affecting up to 9% of children and substantial numbers of adults. Existing pharmacologic treatments often improve symptoms, but concerns exist over side effects, stigma, potential long-term health effects, and residual irritability, often treated with adjunctive antipsychotics. To address public and clinician demand for non-pharmacologic evidence-based treatments, this study will examine efficacy of a 36-ingredient micronutrient (vitamin/mineral) supplement as treatment for children with ADHD and irritability.
Methods


An international team of experts in ADHD, mood dysregulation, nutrition, epidemiology, and clinical trials conferred to develop/refine a protocol powered to detect a medium effect. The study will employ a fully-blind randomized controlled trial (RCT) design, comparing the micronutrient supplement to matched placebo in 135 children aged 6-12 with ADHD symptoms and irritability, based on the parent-rated Child and Adolescent Symptom Inventory-5 (CASI-5). Irritability will be measured by at least one symptom of oppositional defiant disorder (ODD) or disruptive mood dysregulation disorder (DMDD). Based on research suggesting an irritable ADHD subtype, the primary outcome will be a composite score comprised of the CASI-5 subscales: ADHD, ODD, DMDD, and the Peer Conflict Scale, which assesses anger and aggression perpetrated towards peers. Participants will provide biological samples (blood, urine, saliva, hair and stool) to explore the micronutrients' mechanisms of action.
Discussion


This study is the first adequately powered RCT in North America to examine both behavioral responses to, and biological mechanisms of, micronutrients for ADHD and irritability in children. If found efficacious, broad-spectrum micronutrients, given at therapeutic doses, may provide an evidence-based alternative to prescription medications for ADHD and associated irritability.
Trial registration


NCT03252522. Registered 26 July 2017.",2019,"Existing pharmacologic treatments often improve symptoms, but concerns exist over side effects, stigma, potential long-term health effects, and residual irritability, often treated with adjunctive antipsychotics.","['children', 'children with ADHD and irritable mood', 'children with ADHD and irritability', '135 children aged 6-12 with ADHD symptoms and irritability, based on the parent-rated Child and Adolescent Symptom Inventory-5 (CASI-5']","['36-ingredient micronutrient supplement', 'micronutrient supplement to matched placebo', 'placebo', '36-ingredient micronutrient (vitamin/mineral) supplement', '\n\n\nAttention-Deficit/Hyperactivity Disorder (ADHD']",['Irritability'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]","[{'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}]","[{'cui': 'C0022107', 'cui_str': 'Irritable Mood'}]",135.0,0.361218,"Existing pharmacologic treatments often improve symptoms, but concerns exist over side effects, stigma, potential long-term health effects, and residual irritability, often treated with adjunctive antipsychotics.","[{'ForeName': 'Jeanette M', 'Initials': 'JM', 'LastName': 'Johnstone', 'Affiliation': 'National University of Natural Medicine, Helfgott Research Institute, Portland, OR, USA.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Leung', 'Affiliation': 'Faculty of Health Sciences, University of Lethbridge, Lethbridge, Alberta, Canada.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Gracious', 'Affiliation': 'Department of Psychiatry & Behavioral Health, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Leanna', 'Initials': 'L', 'LastName': 'Perez', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Tost', 'Affiliation': 'Department of Child & Adolescent Psychiatry, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Savoy', 'Affiliation': 'Department of Child & Adolescent Psychiatry, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Hatsu', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hughes', 'Affiliation': 'Department of Child & Adolescent Psychiatry, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Alisha', 'Initials': 'A', 'LastName': 'Bruton', 'Affiliation': 'National University of Natural Medicine, Helfgott Research Institute, Portland, OR, USA.'}, {'ForeName': 'L Eugene', 'Initials': 'LE', 'LastName': 'Arnold', 'Affiliation': 'Department of Psychiatry & Behavioral Health, The Ohio State University, Columbus, OH, USA.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2019.100478']
473,32272777,The Preventive Effect of Lactoferrin-Containing Yogurt on Gastroenteritis in Nursery School Children-Intervention Study for 15 Weeks.,"To evaluate the effects of bovine lactoferrin (LF)-containing yogurt on gastroenteritis in nursery school children during the winter season, we conducted a randomized prospective study. A total of 1296 children were randomized into a group in which LF was provided in yogurt (LF group,  n  = 661) and a non-LF consumption group (control group,  n  = 635). The LF group was given LF-containing yogurt (100 mg/day) on all 5 weekdays for approximately 15 weeks, and the control group consumed fruit jelly instead of the yogurt. The final totals of 578 children as the LF group and 584 as the control group were analyzed. The total number of children who were absent from school due to vomiting was significantly lower in the LF group compared to the control, accounting for ≥3 days in any week: 10/234 (4.3%) vs. 49/584 (8.4%), respectively;  p  = 0.04. Regarding the relationship between absences due to vomiting and the consumption of the LF-containing yogurt, the adjusted odds ratio for absence due to vomiting was 2.48 (95% CI: 1.19-5.14) in the LF children who consumed LF-containing yogurt ≤2 days/week compared to the LF children who consumed the yogurt ≥ 3 days/week. The consumption of LF-containing yogurt (100 mg/day) for ≥3 days/week might help alleviate the symptom of vomiting in nursery school children during the winter.",2020,"The total number of children who were absent from school due to vomiting was significantly lower in the LF group compared to the control, accounting for ≥3 days in any week: 10/234 (4.3%) vs. 49/584 (8.4%), respectively;  p  = 0.04.","['1296 children', '578 children as the LF group and 584 as the control group were analyzed', 'Nursery School Children-Intervention Study for 15 Weeks', 'nursery school children during the winter season', 'nursery school children during the winter']","['LF was provided in yogurt (LF group,  n  = 661) and a non-LF consumption group (control group,  n  = 635', 'bovine lactoferrin (LF)-containing yogurt', 'control group consumed fruit jelly instead of the yogurt', 'Lactoferrin-Containing Yogurt']","['symptom of vomiting', 'total number of children who were absent from school due to vomiting']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036379', 'cui_str': 'Nursery school'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}]","[{'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1440867', 'cui_str': 'Bovine lactoferrin'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",1296.0,0.0255412,"The total number of children who were absent from school due to vomiting was significantly lower in the LF group compared to the control, accounting for ≥3 days in any week: 10/234 (4.3%) vs. 49/584 (8.4%), respectively;  p  = 0.04.","[{'ForeName': 'Teruomi', 'Initials': 'T', 'LastName': 'Tsukahara', 'Affiliation': 'Department of Occupational Medicine, School of Medicine, Shinshu University, 3-1-1 Asahi, Matsumoto, Nagano 390-8621, Japan.'}, {'ForeName': 'Anri', 'Initials': 'A', 'LastName': 'Fujimori', 'Affiliation': 'Department of Preventive Medicine and Public Health, School of Medicine, Shinshu University, 3-1-1 Asahi, Matsumoto, Nagano 390-8621, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Misawa', 'Affiliation': 'Department of Preventive Medicine and Public Health, School of Medicine, Shinshu University, 3-1-1 Asahi, Matsumoto, Nagano 390-8621, Japan.'}, {'ForeName': 'Hirotsugu', 'Initials': 'H', 'LastName': 'Oda', 'Affiliation': 'Food Ingredients and Technology Institute, R&D Division, Morinaga Milk Industry Co., Ltd, Zama, Kanagawa 252-8583, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Yamauchi', 'Affiliation': 'Food Ingredients and Technology Institute, R&D Division, Morinaga Milk Industry Co., Ltd, Zama, Kanagawa 252-8583, Japan.'}, {'ForeName': 'Fumiaki', 'Initials': 'F', 'LastName': 'Abe', 'Affiliation': 'Food Ingredients and Technology Institute, R&D Division, Morinaga Milk Industry Co., Ltd, Zama, Kanagawa 252-8583, Japan.'}, {'ForeName': 'Tetsuo', 'Initials': 'T', 'LastName': 'Nomiyama', 'Affiliation': 'Department of Occupational Medicine, School of Medicine, Shinshu University, 3-1-1 Asahi, Matsumoto, Nagano 390-8621, Japan.'}]",International journal of environmental research and public health,['10.3390/ijerph17072534']
474,32167305,Effect of Sanitation Improvements on Pathogens and Microbial Source Tracking Markers in the Rural Bangladeshi Household Environment.,"Diarrheal illnesses from enteric pathogens are a leading cause of death in children under five in low- and middle-income countries (LMICs). Sanitation is one way to reduce the spread of enteric pathogens in the environment; however, few studies have investigated the effectiveness of sanitation in rural LMICs in reducing pathogens in the environment. In this study, we measured the impact of a sanitation intervention (dual-pit latrines, sani-scoops, child potties delivered as part of a randomized control trial, WASH Benefits) in rural Bangladeshi household compounds by assessing prevalence ratios, differences, and changes in the concentration of pathogen genes and host-specific fecal markers. We found no difference in the prevalence of pathogenic  Escherichia coli , norovirus, or  Giardia  genes in the domestic environment in the sanitation and control arms. The prevalence of the human fecal marker was lower on child hands and the concentration of animal fecal marker was lower on mother hands in the sanitation arm in adjusted models, but these associations were not significant after correcting for multiple comparisons. In the subset of households with ≥10 individuals per compound, the prevalence of enterotoxigenic  E. coli  genes on child hands was lower in the sanitation arm. Incomplete removal of child and animal feces or the compound (versus community-wide) scale of intervention could explain the limited impacts of improved sanitation.",2020,"The prevalence of the human fecal marker was lower on child hands and the concentration of animal fecal marker was lower on mother hands in the sanitation arm in adjusted models, but these associations were not significant after correcting for multiple comparisons.","['children under five in low-and-middle income countries (LMICs', 'rural Bangladeshi household environment']","['sanitation intervention (dual pit latrines, sani-scoop, child potties']","['concentration of animal fecal marker', 'concentration of pathogen genes and host-specific fecal markers', 'pathogens and microbial source tracking markers', 'prevalence of pathogenic E. coli, norovirus, or Giardia genes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0422784', 'cui_str': 'Bangladeshi'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C3266595', 'cui_str': 'Pit latrine'}, {'cui': 'C0183177', 'cui_str': 'Scoop'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0003062', 'cui_str': 'Animals'}, {'cui': 'C0450254', 'cui_str': 'Pathogen'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0017534', 'cui_str': 'Lamblia'}]",,0.0392279,"The prevalence of the human fecal marker was lower on child hands and the concentration of animal fecal marker was lower on mother hands in the sanitation arm in adjusted models, but these associations were not significant after correcting for multiple comparisons.","[{'ForeName': 'Erica R', 'Initials': 'ER', 'LastName': 'Fuhrmeister', 'Affiliation': 'Department of Civil and Environmental Engineering, University of California, Berkeley, California 94720, United States.'}, {'ForeName': 'Ayse', 'Initials': 'A', 'LastName': 'Ercumen', 'Affiliation': 'School of Public Health, University of California, Berkeley, California 94720, United States.'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Pickering', 'Affiliation': 'Civil and Environmental Engineering, Tufts University, Medford, Massachusetts 02153, United States.'}, {'ForeName': 'Kaitlyn M', 'Initials': 'KM', 'LastName': 'Jeanis', 'Affiliation': 'Department of Civil and Environmental Engineering, University of California, Berkeley, California 94720, United States.'}, {'ForeName': 'Yoshika', 'Initials': 'Y', 'LastName': 'Crider', 'Affiliation': 'Energy and Resources Group, University of California, Berkeley, California 94720, United States.'}, {'ForeName': 'Mahaa', 'Initials': 'M', 'LastName': 'Ahmed', 'Affiliation': 'Department of Civil and Environmental Engineering, University of California, Berkeley, California 94720, United States.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Brown', 'Affiliation': 'Department of Civil and Environmental Engineering, University of California, Berkeley, California 94720, United States.'}, {'ForeName': 'Mahfuja', 'Initials': 'M', 'LastName': 'Alam', 'Affiliation': 'Infectious Disease Division, International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka 1212, Bangladesh.'}, {'ForeName': 'Debashis', 'Initials': 'D', 'LastName': 'Sen', 'Affiliation': 'Infectious Disease Division, International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka 1212, Bangladesh.'}, {'ForeName': 'Sharmin', 'Initials': 'S', 'LastName': 'Islam', 'Affiliation': 'Infectious Disease Division, International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka 1212, Bangladesh.'}, {'ForeName': 'Mir Himayet', 'Initials': 'MH', 'LastName': 'Kabir', 'Affiliation': 'Infectious Disease Division, International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka 1212, Bangladesh.'}, {'ForeName': 'Mahfuza', 'Initials': 'M', 'LastName': 'Islam', 'Affiliation': 'Infectious Disease Division, International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka 1212, Bangladesh.'}, {'ForeName': 'Mahbubur', 'Initials': 'M', 'LastName': 'Rahman', 'Affiliation': 'Infectious Disease Division, International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka 1212, Bangladesh.'}, {'ForeName': 'Laura H', 'Initials': 'LH', 'LastName': 'Kwong', 'Affiliation': 'Department of Civil and Environmental Engineering, Stanford University, Stanford, California 94305, United States.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Arnold', 'Affiliation': 'School of Public Health, University of California, Berkeley, California 94720, United States.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Luby', 'Affiliation': 'Woods Institute for the Environment, Stanford University, Stanford, California 94305, United States.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Colford', 'Affiliation': 'School of Public Health, University of California, Berkeley, California 94720, United States.'}, {'ForeName': 'Kara L', 'Initials': 'KL', 'LastName': 'Nelson', 'Affiliation': 'Department of Civil and Environmental Engineering, University of California, Berkeley, California 94720, United States.'}]",Environmental science & technology,['10.1021/acs.est.9b04835']
475,32182353,Which Components of a Smartphone Walking App Help Users to Reach Personalized Step Goals? Results From an Optimization Trial.,"BACKGROUND


The Assistant to Lift your Level of activitY (Ally) app is a smartphone application that combines financial incentives with chatbot-guided interventions to encourage users to reach personalized daily step goals.
PURPOSE


To evaluate the effects of incentives, weekly planning, and daily self-monitoring prompts that were used as intervention components as part of the Ally app.
METHODS


We conducted an 8 week optimization trial with n = 274 insurees of a health insurance company in Switzerland. At baseline, participants were randomized to different incentive conditions (cash incentives vs. charity incentives vs. no incentives). Over the course of the study, participants were randomized weekly to different planning conditions (action planning vs. coping planning vs. no planning) and daily to receiving or not receiving a self-monitoring prompt. Primary outcome was the achievement of personalized daily step goals.
RESULTS


Study participants were more active and healthier than the general Swiss population. Daily cash incentives increased step-goal achievement by 8.1%, 95% confidence interval (CI): [2.1, 14.1] and, only in the no-incentive control group, action planning increased step-goal achievement by 5.8%, 95% CI: [1.2, 10.4]. Charity incentives, self-monitoring prompts, and coping planning did not affect physical activity. Engagement with planning interventions and self-monitoring prompts was low and 30% of participants stopped using the app over the course of the study.
CONCLUSIONS


Daily cash incentives increased physical activity in the short term. Planning interventions and self-monitoring prompts require revision before they can be included in future versions of the app. Selection effects and engagement can be important challenges for physical-activity apps.
CLINICAL TRIAL INFORMATION


This study was registered on ClinicalTrials.gov, NCT03384550.",2020,"Daily cash incentives increased step-goal achievement by 8.1%, 95% confidence interval (CI): [2.1, 14.1] and, only in the no-incentive control group, action planning increased step-goal achievement by 5.8%, 95% CI: [1.2, 10.4].",['n = 274 insurees of a health insurance company in Switzerland'],"['planning conditions (action planning vs. coping planning vs. no planning) and daily to receiving or not receiving a self-monitoring prompt', 'incentive conditions (cash incentives vs. charity incentives vs. no incentives']","['physical activity', 'step-goal achievement', 'achievement of personalized daily step goals']","[{'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}]","[{'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0007962', 'cui_str': 'Charities'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",,0.0829464,"Daily cash incentives increased step-goal achievement by 8.1%, 95% confidence interval (CI): [2.1, 14.1] and, only in the no-incentive control group, action planning increased step-goal achievement by 5.8%, 95% CI: [1.2, 10.4].","[{'ForeName': 'Jan-Niklas', 'Initials': 'JN', 'LastName': 'Kramer', 'Affiliation': 'Institute of Technology Management (ITEM), University of St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Künzler', 'Affiliation': 'Department of Management, Technology and Economics, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Varun', 'Initials': 'V', 'LastName': 'Mishra', 'Affiliation': 'Department of Computer Science, Dartmouth College, Hanover, NH, USA.'}, {'ForeName': 'Shawna N', 'Initials': 'SN', 'LastName': 'Smith', 'Affiliation': 'Institute for Social Research, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kotz', 'Affiliation': 'Department of Computer Science, Dartmouth College, Hanover, NH, USA.'}, {'ForeName': 'Urte', 'Initials': 'U', 'LastName': 'Scholz', 'Affiliation': 'Department of Psychology, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Elgar', 'Initials': 'E', 'LastName': 'Fleisch', 'Affiliation': 'Institute of Technology Management (ITEM), University of St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Kowatsch', 'Affiliation': 'Institute of Technology Management (ITEM), University of St. Gallen, St. Gallen, Switzerland.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa002']
476,32271261,Effect of semaglutide on coronary atherosclerosis progression in patients with type II diabetes: rationale and design of the semaglutide treatment on coronary progression trial.,"BACKGROUND


Cardiovascular morbidity and mortality are a major burden in patients with type 2 diabetic mellitus. In a landmark study, semaglutide (an injectable glucagon like peptide-1 receptor agonist) has been shown to significantly reduce cardiovascular events, however, the mechanism of benefit is still unknown. The primary hypothesis of our current study is to assess the effect of semaglutide to reduce progression of noncalcified coronary atherosclerotic plaque volume as measured by serial coronary CTA as compared to placebo in persons with diabetes over 1 year.
METHODS


One hundred forty patients will be enrolled after signing informed consent and followed up for 12 months and with a phone call 30 days after medical discontinuation. All the participants will undergo coronary artery calcium scoring and coronary computed tomography angiography at our center at baseline and 12 months. Eligible participants will be randomly assigned to semaglutide 2 mg/1.5 ml (1.34 mg/ml) prefilled pen for subcutaneous (SC) injection or placebo 1.5 ml, pen-injector for SC injection in a 1:1 fashion as add-on to their standard of care.
RESULTS


As of July 2019, the study was approximately 30% enrolled with an estimated enrollment completion by first quarter of 2020 and end of study by first quarter 2021. Thirty patients were enrolled as of 23 July 2019. Preliminary data of demographics and clinical characteristics were summarized.
CONCLUSION


Our current study will provide important imaging-derived data that may add relevance to the clinically derived outcomes from liraglutide effect and action in diabetes: evaluation of cardiovascular outcome results and semaglutide and cardiovascular outcomes in patients with type 2 diabetic mellitus 6 trials.",2020,"As of July 2019, the study was approximately 30% enrolled with an estimated enrollment completion by first quarter of 2020 and end of study by first quarter 2021.","['One hundred forty patients will be enrolled after signing informed consent and followed up for 12 months and with a phone call 30 days after medical discontinuation', 'persons with diabetes over 1 year', 'patients with type II diabetes', 'Eligible participants', 'patients with type 2 diabetic mellitus', 'Thirty patients were enrolled as of 23 July 2019', 'patients with type 2 diabetic mellitus 6 trials', 'As of July 2019, the study was approximately 30% enrolled with an estimated enrollment completion by first quarter of 2020 and end of study by first quarter 2021']","['semaglutide', 'coronary artery calcium scoring and coronary computed tomography angiography', 'placebo', 'semaglutide 2 mg/1.5 ml (1.34 mg/ml) prefilled pen for subcutaneous (SC) injection or placebo 1.5 ml, pen-injector for SC injection']","['cardiovascular events', 'coronary atherosclerosis progression']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0444930', 'cui_str': 'End'}]","[{'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C2825178', 'cui_str': 'Coronary artery calcium score'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517501', 'cui_str': '1.34'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0070220', 'cui_str': 'penclomedine'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C4025916', 'cui_str': 'Pen Injector'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",30.0,0.200433,"As of July 2019, the study was approximately 30% enrolled with an estimated enrollment completion by first quarter of 2020 and end of study by first quarter 2021.","[{'ForeName': 'Sajad', 'Initials': 'S', 'LastName': 'Hamal', 'Affiliation': ''}, {'ForeName': 'Lavanya', 'Initials': 'L', 'LastName': 'Cherukuri', 'Affiliation': ''}, {'ForeName': 'Kashif', 'Initials': 'K', 'LastName': 'Shaikh', 'Affiliation': ''}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Kinninger', 'Affiliation': ''}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Doshi', 'Affiliation': ''}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Birudaraju', 'Affiliation': ''}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Budoff', 'Affiliation': ''}]",Coronary artery disease,['10.1097/MCA.0000000000000830']
477,32078086,Improvement in resiliency factors among adolescents with neurofibromatosis who participate in a virtual mind-body group program.,"PURPOSE


To examine effects of a virtual mind-body group for adolescents with neurofibromatoses (NF1 and NF2; Resilient Youth with Neurofibromatosis; RY-NF) on multiple resiliency factors against a health education attention control (Health Education for Youth with Neurofibromatosis; HE-NF) using data from a randomized controlled trial. Specifically, our research question was whether adolescents randomized to the RY-NF (versus the HE-NF) would have greater improvements in resiliency factors at post-intervention and whether these gains would be maintained at 6-month follow-up.
METHODS


Adolescents with NF (n = 51; M age 12-17) were randomly assigned to RY-NF (n = 27) or HE-NF (n = 24). Resiliency factors (mindfulness, coping, gratitude, optimism, and social support) were collected at baseline, post-intervention (88%), and 6-month follow-up (82%).
RESULTS


Participation in the RY-NF was associated with greater pre-to-post improvements in gratitude (M difference  = 4.38; 95% CI-0.52-8.23; p = .027) and mindfulness (M difference = 9.41; 95% CI 4.40-14.42.; p < .001) compared to HE-NF; improvements sustained at 6 months. There were no group differences on any additional resiliency factors. However, participation in the RY-NF was associated with pre-to-post- improvements in coping (M difference = 9.16; 95% CI 2.93-15.39; p = .005), and social support (M difference = 6.79; 95% CI 1.96-11.63; p = .007); improvements sustained at 6 months.
CONCLUSIONS


Participation in the RY-NF resulted in sustained improvement in several resiliency factors. Promoting resiliency may help adolescents successfully navigate challenges associated with NF.",2020,"RESULTS


Participation in the RY-NF was associated with greater pre-to-post improvements in gratitude (M difference  = 4.38; 95% CI-0.52-8.23; p = .027) and mindfulness (M difference = 9.41; 95% CI 4.40-14.42.","['adolescents with neurofibromatoses (NF1 and NF2; Resilient Youth with', 'adolescents with neurofibromatosis who participate in a virtual mind-body group program', 'Adolescents with NF (n\u2009=\u200951; M age 12-17']","['HE-NF', 'Neurofibromatosis; RY-NF', 'virtual mind-body group', 'RY-NF']","['social support', 'Resiliency factors (mindfulness, coping, gratitude, optimism, and social support']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0162678', 'cui_str': 'Multiple Neurofibromas'}, {'cui': 'C0027832', 'cui_str': 'Neurofibromatosis, Central, NF 2'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0162678', 'cui_str': 'Multiple Neurofibromas'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0037438'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0237428', 'cui_str': 'Optimism'}]",,0.0885728,"RESULTS


Participation in the RY-NF was associated with greater pre-to-post improvements in gratitude (M difference  = 4.38; 95% CI-0.52-8.23; p = .027) and mindfulness (M difference = 9.41; 95% CI 4.40-14.42.","[{'ForeName': 'Ethan G', 'Initials': 'EG', 'LastName': 'Lester', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Psychiatry Department, Massachusetts General Hospital, One Bowdoin Square, 1st Floor, Boston, MA, 02114, USA.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Macklin', 'Affiliation': 'Harvard Medical School, One Bowdoin Square, 1st Floor, Boston, MA, 02114, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Plotkin', 'Affiliation': 'Harvard Medical School, One Bowdoin Square, 1st Floor, Boston, MA, 02114, USA.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Vranceanu', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Psychiatry Department, Massachusetts General Hospital, One Bowdoin Square, 1st Floor, Boston, MA, 02114, USA. avranceanu@mgh.harvard.edu.'}]",Journal of neuro-oncology,['10.1007/s11060-020-03441-8']
478,32096852,Comparison of Abbreviated Breast MRI vs Digital Breast Tomosynthesis for Breast Cancer Detection Among Women With Dense Breasts Undergoing Screening.,"Importance


Improved screening methods for women with dense breasts are needed because of their increased risk of breast cancer and of failed early diagnosis by screening mammography.
Objective


To compare the screening performance of abbreviated breast magnetic resonance imaging (MRI) and digital breast tomosynthesis (DBT) in women with dense breasts.
Design, Setting, and Participants


Cross-sectional study with longitudinal follow-up at 48 academic, community hospital, and private practice sites in the United States and Germany, conducted between December 2016 and November 2017 among average-risk women aged 40 to 75 years with heterogeneously dense or extremely dense breasts undergoing routine screening. Follow-up ascertainment of cancer diagnoses was complete through September 12, 2019.
Exposures


All women underwent screening by both DBT and abbreviated breast MRI, performed in randomized order and read independently to avoid interpretation bias.
Main Outcomes and Measures


The primary end point was the invasive cancer detection rate. Secondary outcomes included sensitivity, specificity, additional imaging recommendation rate, and positive predictive value (PPV) of biopsy, using invasive cancer and ductal carcinoma in situ (DCIS) to define a positive reference standard. All outcomes are reported at the participant level. Pathology of core or surgical biopsy was the reference standard for cancer detection rate and PPV; interval cancers reported until the next annual screen were included in the reference standard for sensitivity and specificity.
Results


Among 1516 enrolled women, 1444 (median age, 54 [range, 40-75] years) completed both examinations and were included in the analysis. The reference standard was positive for invasive cancer with or without DCIS in 17 women and for DCIS alone in another 6. No interval cancers were observed during follow-up. Abbreviated breast MRI detected all 17 women with invasive cancer and 5 of 6 women with DCIS. Digital breast tomosynthesis detected 7 of 17 women with invasive cancer and 2 of 6 women with DCIS. The invasive cancer detection rate was 11.8 (95% CI, 7.4-18.8) per 1000 women for abbreviated breast MRI vs 4.8 (95% CI, 2.4-10.0) per 1000 women for DBT, a difference of 7 (95% CI, 2.2-11.6) per 1000 women (exact McNemar P = .002). For detection of invasive cancer and DCIS, sensitivity was 95.7% (95% CI, 79.0%-99.2%) with abbreviated breast MRI vs 39.1% (95% CI, 22.2%-59.2%) with DBT (P = .001) and specificity was 86.7% (95% CI, 84.8%-88.4%) vs 97.4% (95% CI, 96.5%-98.1%), respectively (P < .001). The additional imaging recommendation rate was 7.5% (95% CI, 6.2%-9.0%) with abbreviated breast MRI vs 10.1% (95% CI, 8.7%-11.8%) with DBT (P = .02) and the PPV was 19.6% (95% CI, 13.2%-28.2%) vs 31.0% (95% CI, 17.0%-49.7%), respectively (P = .15).
Conclusions and Relevance


Among women with dense breasts undergoing screening, abbreviated breast MRI, compared with DBT, was associated with a significantly higher rate of invasive breast cancer detection. Further research is needed to better understand the relationship between screening methods and clinical outcome.
Trial Registration


ClinicalTrials.gov Identifier: NCT02933489.",2020,"For detection of invasive cancer and DCIS, sensitivity was 95.7% (95% CI, 79.0%-99.2%) with abbreviated breast MRI vs 39.1% (95% CI, 22.2%-59.2%) with DBT (P = .001) and specificity was 86.7% (95% CI, 84.8%-88.4%) vs 97.4% (95% CI, 96.5%-98.1%), respectively (P < .001).","['Women With Dense Breasts Undergoing Screening', 'women with dense breasts', '17 women with invasive cancer and 2 of 6 women with DCIS', '1516 enrolled women, 1444 (median age, 54 [range, 40-75] years) completed both examinations and were included in the analysis', 'Breast Cancer Detection', 'Participants\n\n\nCross-sectional study with longitudinal follow-up at 48 academic, community hospital, and private practice sites in the United States and Germany, conducted between December 2016 and November 2017 among average-risk women aged 40 to 75 years with heterogeneously dense or extremely dense breasts undergoing routine screening', '17 women with invasive cancer and 5 of 6 women with DCIS']","['abbreviated breast magnetic resonance imaging (MRI) and digital breast tomosynthesis (DBT', 'Abbreviated Breast MRI vs Digital Breast Tomosynthesis']","['additional imaging recommendation rate', 'PPV', 'No interval cancers', 'sensitivity, specificity, additional imaging recommendation rate, and positive predictive value (PPV) of biopsy, using invasive cancer and ductal carcinoma in situ (DCIS', 'invasive cancer detection rate', 'rate of invasive breast cancer detection', 'specificity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0010362', 'cui_str': 'Disease Frequency Surveys'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0020003', 'cui_str': 'Hospitals, Community'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C3472347', 'cui_str': 'Breast Tomosyntheses, X-ray'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]","[{'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C2919572', 'cui_str': 'Malignant neoplasm detection during interval between recommended screening examinations (finding)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0007124', 'cui_str': 'Ductal Carcinoma In Situ'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]",1516.0,0.363375,"For detection of invasive cancer and DCIS, sensitivity was 95.7% (95% CI, 79.0%-99.2%) with abbreviated breast MRI vs 39.1% (95% CI, 22.2%-59.2%) with DBT (P = .001) and specificity was 86.7% (95% CI, 84.8%-88.4%) vs 97.4% (95% CI, 96.5%-98.1%), respectively (P < .001).","[{'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Comstock', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Gatsonis', 'Affiliation': 'Department of Biostatistics and Center for Statistical Sciences, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Gillian M', 'Initials': 'GM', 'LastName': 'Newstead', 'Affiliation': 'University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Bradley S', 'Initials': 'BS', 'LastName': 'Snyder', 'Affiliation': 'Center for Statistical Sciences, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Ilana F', 'Initials': 'IF', 'LastName': 'Gareen', 'Affiliation': 'Center for Statistical Sciences, Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Jennifer T', 'Initials': 'JT', 'LastName': 'Bergin', 'Affiliation': 'UW Cancer Center at ProHealth Care, Waukesha, Wisconsin.'}, {'ForeName': 'Habib', 'Initials': 'H', 'LastName': 'Rahbar', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Janice S', 'Initials': 'JS', 'LastName': 'Sung', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Jacobs', 'Affiliation': 'West Michigan Cancer Center, Kalamazoo.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Harvey', 'Affiliation': 'University of Virginia Cancer Center, Charlottesville.'}, {'ForeName': 'Mary H', 'Initials': 'MH', 'LastName': 'Nicholson', 'Affiliation': 'Community Hospital, Munster, Indiana.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Ward', 'Affiliation': 'Rhode Island Hospital, Providence.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Holt', 'Affiliation': 'Delaware/Christiana Care NCORP, Newark.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Prather', 'Affiliation': 'Gundersen Health System, La Crosse, Wisconsin.'}, {'ForeName': 'Kathy D', 'Initials': 'KD', 'LastName': 'Miller', 'Affiliation': 'Indiana University, Indianapolis.'}, {'ForeName': 'Mitchell D', 'Initials': 'MD', 'LastName': 'Schnall', 'Affiliation': 'University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Christiane K', 'Initials': 'CK', 'LastName': 'Kuhl', 'Affiliation': 'University Hospital of RWTH Aachen, Aachen, Germany.'}]",JAMA,['10.1001/jama.2020.0572']
479,32276452,Can Post-Activation Performance Enhancement (PAPE) Improve Resistance Training Volume during the Bench Press Exercise?,"Background : The aim of the present study was to evaluate the effects of post-activation performance enhancement (PAPE) on resistance training volume during the bench press exercise (BP). The study included 12 healthy strength-trained males (age 25.2 ± 2.1 years, body mass 92.1 ± 8.7 kg, BP one-repetition maximum (1RM) 28.8 ± 10.5 kg, training experience 6.3 ± 2.1 years).  Methods : The experiment was performed following a randomized crossover design, where each participant performed two different exercise protocols with a conditioning activity (CA) consisting of the BP with three sets of three repetitions at 85% 1RM (PAPE), and a control without the CA (CONT). To assess the differences between PAPE and CONT, the participants performed three sets of the BP to volitional failure at 60% 1RM. The differences in the number of performed repetitions (REP), time under tension (TUT), peak power output (PP), mean of peak power output (PP MEAN ), mean power output (MP), peak bar velocity (PV), mean of peak bar velocity (PV MEAN ), and mean bar velocity (MV) between the CONT and PAPE conditions were examined using repeated measures ANOVA.  Results : The post-hoc analysis for the main condition effect indicated significant increases in TUT ( p  < 0.01) for the BP following PAPE, compared to the CONT condition. Furthermore, there was a significant increase in TUT ( p  < 0.01) in the third set for PAPE compared to the CONT condition. No statistically significant main effect was revealed for REP, PP, PV, PP MEAN , PV MEAN , MP, and MV.  Conclusion : The main finding of the study was that the PAPE protocol increased training volume based on TUT, without changes in the number of preformed REP.",2020,"The post-hoc analysis for the main condition effect indicated significant increases in TUT ( p  < 0.01) for the BP following PAPE, compared to the CONT condition.","['12 healthy strength-trained males (age 25.2 ± 2.1 years, body mass 92.1 ± 8.7 kg, BP one-repetition maximum (1RM) 28.8 ± 10.5 kg, training experience 6.3 ± 2.1 years']","[' ', 'post-activation performance enhancement (PAPE', 'control without the CA (CONT']","['REP, PP, PV, PP MEAN , PV MEAN , MP, and MV', 'TUT', 'number of performed repetitions (REP), time under tension (TUT), peak power output (PP), mean of peak power output (PP MEAN ), mean power output (MP), peak bar velocity (PV), mean of peak bar velocity (PV MEAN ), and mean bar velocity (MV']","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517880', 'cui_str': '8.7'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4319697', 'cui_str': '6.3'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}]",12.0,0.0286939,"The post-hoc analysis for the main condition effect indicated significant increases in TUT ( p  < 0.01) for the BP following PAPE, compared to the CONT condition.","[{'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Krzysztofik', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Wilk', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Filip', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Zmijewski', 'Affiliation': 'Jozef Pilsudski University of Physical Education in Warsaw, 00-809 Warsaw, Poland.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Zajac', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Tufano', 'Affiliation': 'Faculty of Physical Education and Sport, Charles University, 16000 Prague, Czech Republic.'}]",International journal of environmental research and public health,['10.3390/ijerph17072554']
480,32276515,Effects of Exergames on Physical Fitness in Middle-Aged and Older Adults in Taiwan.,"Using exergaming for exercise training was found to improve physical fitness. Yet, few studies have used the ""Xbox Kinect"" to examine its effects on physical fitness in healthy middle-aged and older adults. The purpose of this study was to investigate the effect of 10-weeks of Xbox Kinect training on physical fitness in healthy middle-aged and older adults. Forty participants (average 64.00 ± 4.44 years old, eight males and 32 females) were randomized to either intervention (n = 20) or control group (n = 20). The intervention group played Xbox Kinect three times per week, for an average of 50 min per session for 10 weeks. The control group was instructed to maintain their levels of physical activity. All the participants completed assessments of body composition, muscle strength, flexibility, balance and cardiopulmonary endurance at baseline and after 10-week intervention. After 10 weeks of training, the intervention group showed significant improvements in cardiopulmonary endurance and leg muscle strength. Moreover, there were significant differences between the intervention and control group in changes in aerobic fitness and leg muscle strength. The exergame program effectively improved cardiopulmonary endurance and leg muscle strength in healthy middle-aged and older adults. It could be an alternative to conventional exercise.",2020,"Moreover, there were significant differences between the intervention and control group in changes in aerobic fitness and leg muscle strength.","['Forty participants (average 64.00 ± 4.44 years old, eight males and 32 females', 'Middle-Aged and Older Adults in Taiwan', 'healthy middle-aged and older adults']","['exercise training', 'Xbox Kinect training']","['body composition, muscle strength, flexibility, balance and cardiopulmonary endurance', 'Physical Fitness', 'physical fitness', 'aerobic fitness and leg muscle strength', 'cardiopulmonary endurance and leg muscle strength']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0224456', 'cui_str': 'Skeletal muscle structure of lower leg'}]",40.0,0.0142364,"Moreover, there were significant differences between the intervention and control group in changes in aerobic fitness and leg muscle strength.","[{'ForeName': 'Tzu-Cheng', 'Initials': 'TC', 'LastName': 'Yu', 'Affiliation': 'College of Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan.'}, {'ForeName': 'Che-Hsien', 'Initials': 'CH', 'LastName': 'Chiang', 'Affiliation': 'Department of Sports Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan.'}, {'ForeName': 'Pei-Tzu', 'Initials': 'PT', 'LastName': 'Wu', 'Affiliation': 'Department of Rehabilitation, Oregon Health and Science University Hospital, Portland, OR 97239, USA.'}, {'ForeName': 'Wen-Lan', 'Initials': 'WL', 'LastName': 'Wu', 'Affiliation': 'Department of Sports Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan.'}, {'ForeName': 'I-Hua', 'Initials': 'IH', 'LastName': 'Chu', 'Affiliation': 'College of Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph17072565']
481,32277872,"Heat-inactivated Bifidobacterium bifidum MIMBb75 (SYN-HI-001) in the treatment of irritable bowel syndrome: a multicentre, randomised, double-blind, placebo-controlled clinical trial.","BACKGROUND


Bifidobacterium bifidum MIMBb75 is one of a few probiotic strains that have been shown to be effective in the treatment of irritable bowel syndrome (IBS) and its symptoms. Non-viable strains might have advantages over viable bacteria for product stability and standardisation, as well as for tolerability because safety concerns have been raised for specific patient groups who are susceptible to infection. We aimed to assess the efficacy of non-viable, heat-inactivated (HI) B bifidum MIMBb75 (SYN-HI-001) in the treatment of IBS and its symptoms.
METHODS


We did a double-blind, placebo-controlled trial in which patients with IBS were recruited from 20 study sites in Germany and randomly assigned to receive either two placebo capsules or two capsules with a combined total of 1 × 10 9  non-viable B bifidum HI-MIMBb75 cells to be taken orally once a day for 8 weeks. Eligible patients were diagnosed with IBS according to Rome III criteria and had abdominal pain (≥4 on an 11-point numerical rating scale) on at least 2 days during a 2-week run-in phase. Patients with chronic inflammatory bowel diseases, systemic diseases, cancer, autoimmune diseases, with an intake of antipsychotic medications 3 months before study start, or with an intake of systemic corticosteroids within 1 month before study start were excluded. Randomisation was in a 1:1 ratio according to a computer-generated blocked list. Patients, investigators, clinical monitors, project managers, and statisticians were masked to the randomisation. The primary composite endpoint was the combination of at least 30% improvement of abdominal pain and adequate relief of overall IBS symptoms being fulfilled in at least 4 of 8 weeks during treatment. Analysis of the primary endpoint included all randomly assigned patients receiving at least one dose of study medication and who had no severe protocol violation. Safety analysis included all patients who had taken at least one dose of the study medication and was based on frequency and severity of adverse events, laboratory evaluation, and global assessment of tolerability. This trial is registered with the ISRCTN registry, ISRCTN14066467, and is completed: the results shown here represent the final analysis.
FINDINGS


Patients were screened between April 15, 2016, and Feb 3, 2017, and 443 patients were allocated to the placebo group (n=222) or the B bifidum HI-MIMBb75 group (n=221). The composite primary endpoint was reached by 74 (34%) of 221 patients in the B bifidum HI-MIMBb75 group compared with 43 (19%) of 222 in the placebo group (risk ratio 1·7, 95% CI 1·3-2·4; p=0·0007). No serious adverse events occurred in the B bifidum HI-MIMBb75 group; seven adverse events suspected to be related to the study product were reported in the B bifidum HI-MIMBb75 group as were eight in the placebo group. No deaths were reported in this study. The most common reported adverse event with a suspected relationship to the study product was abdominal pain, which was reported in two (<1%) patients in the B bifidum HI-MIMBb75 group and one (<1%) in the placebo group. Tolerability was rated as very good or good by 200 (91%) patients in the B bifidum HI-MIMBb75 group compared with 191 (86%) in the placebo group.
INTERPRETATION


This study shows that B bifidum HI-MIMBb75 substantially alleviates IBS and its symptoms in a real-life setting. These results indicate that specific beneficial bacterial effects are mediated independently of cell viability.
FUNDING


Synformulas.",2020,No serious adverse events occurred in the B bifidum HI-MIMBb75 group; seven adverse events suspected to be related to the study product were reported in the B bifidum HI-MIMBb75 group as were eight in the placebo group.,"['Patients were screened between April 15, 2016, and Feb 3, 2017, and 443 patients', 'Patients with chronic inflammatory bowel diseases, systemic diseases, cancer, autoimmune diseases, with an intake of antipsychotic medications 3 months before study start, or with an intake of systemic corticosteroids within 1 month before study start were excluded', 'irritable bowel syndrome', 'patients with IBS were recruited from 20 study sites in Germany', 'patients who had taken at least one dose of the study medication and was based on', 'Eligible patients were diagnosed with IBS according to Rome III criteria and had abdominal pain (≥4 on an 11-point numerical rating scale) on at least 2 days during a 2-week run-in phase']","['Heat-inactivated Bifidobacterium bifidum MIMBb75 (SYN-HI-001', 'placebo capsules or two capsules with a combined total of 1\u2008×\u200810 9  non-viable B bifidum HI-MIMBb75 cells', 'placebo', 'B bifidum HI-MIMBb75', 'non-viable, heat-inactivated (HI) B bifidum MIMBb75 (SYN-HI-001']","['combination of at least 30% improvement of abdominal pain and adequate relief of overall IBS symptoms', 'Tolerability', 'frequency and severity of adverse events, laboratory evaluation, and global assessment of tolerability', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0442893', 'cui_str': 'Systemic disease'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0004364', 'cui_str': 'Autoimmune disease'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0314974', 'cui_str': 'Bifidobacterium bifidum'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]","[{'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.363173,No serious adverse events occurred in the B bifidum HI-MIMBb75 group; seven adverse events suspected to be related to the study product were reported in the B bifidum HI-MIMBb75 group as were eight in the placebo group.,"[{'ForeName': 'Viola', 'Initials': 'V', 'LastName': 'Andresen', 'Affiliation': 'Department of Internal Medicine, Israelitic Hospital, University of Hamburg Teaching Hospital, Hamburg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Gschossmann', 'Affiliation': 'Department of Internal Medicine, Hospital Forchheim, Forchheim, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Layer', 'Affiliation': 'Department of Internal Medicine, Israelitic Hospital, University of Hamburg Teaching Hospital, Hamburg, Germany. Electronic address: p.layer@ik-h.de.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(20)30056-X']
482,31577081,A NEW TREATMENT MODALITY TO REDUCE ACUTE TONSILLITIS HEALING TIME.,"BACKGROUND AND OBJECTIVE


Acute tonsillitis is one of the most common reasons for application to otorhinolaryngology clinics. In the treatment of acute tonsillitis, supportive therapies are mostly used. As antibiotic therapy, penicillin or erythromycin can be used. The aim of this study is to decrease the clinical recovery time of acute tonsillitis by providing parenteral treatment and daily cleaning of tonsillar lesions.
MATERIAL AND METHODS


Patients with an age range of 15-60 years were included in the study. The patients were divided into two groups. The first group used an i.v. combination of ampicillin + sulbactam and the tonsillar membranes of patients were cleaned daily. The second group used only the i.v. combination of ampicillin + sulbactam.
RESULTS


Patients who received antibiotherapy and debridement had a clinical improvement of 90% on the 2nd treatment day and 95% on the 5th treatment day. The patients receiving only antibiotics had a clinical improvement of 65% on the 5th treatment day and 75% on the 7th treatment day. The recovery time of both groups was significantly different (p < 0.05).
CONCLUSION


The solution and technique used in this clinical study showed that patients with acute tonsillitis could recover in a very short time without any complications.",2019,"The recovery time of both groups was significantly different (p < 0.05).
","['Patients with an age range of 15-60 years were included in the study', 'patients with acute tonsillitis']","['penicillin or erythromycin', 'antibiotherapy', 'ampicillin + sulbactam']","['clinical improvement', 'recovery time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001361', 'cui_str': 'Acute tonsillitis (disorder)'}]","[{'cui': 'C0030842', 'cui_str': 'Antibiotics, Penicillin'}, {'cui': 'C0014806', 'cui_str': 'Erythromycin'}, {'cui': 'C0002680', 'cui_str': 'Ampicillin'}, {'cui': 'C0038665', 'cui_str': 'Sulbactam'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0163138,"The recovery time of both groups was significantly different (p < 0.05).
","[{'ForeName': 'Huseyin', 'Initials': 'H', 'LastName': 'Keskin', 'Affiliation': 'Department of Otorhinolaryngology, Bor State Hospital, Nigde, Turkey.'}, {'ForeName': 'Oguz', 'Initials': 'O', 'LastName': 'Guvenmez', 'Affiliation': 'Independent Researcher, Internal Medicine and Traditional Medicine, Adana, Turkey. oguzguvenmez001@hotmail.com.'}]",Journal of population therapeutics and clinical pharmacology = Journal de la therapeutique des populations et de la pharmacologie clinique,['10.15586/jptcp.v26i2.616']
483,32071117,"The Effects of a Remote-based Weight Loss Program on Adipocytokines, Metabolic Markers, and Telomere Length in Breast Cancer Survivors: the POWER-Remote Trial.","PURPOSE


We initiated a clinical trial to determine the proportion of breast cancer survivors achieving ≥5% weight loss using a remotely delivered weight loss intervention (POWER-remote) or a self-directed approach, and to determine the effects of the intervention on biomarkers of cancer risk including metabolism, inflammation, and telomere length.
EXPERIMENTAL DESIGN


Women with stage 0-III breast cancer, who completed local therapy and chemotherapy, with a body mass index ≥25 kg/m 2  were randomized to a 12-month intervention (POWER-remote) versus a self-directed approach. The primary objective was to determine the number of women who achieved at least 5% weight loss at 6 months. We assessed baseline and 6-month change in a panel of adipocytokines (adiponectin, leptin, resistin, HGF, NGF, PAI1, TNFα, MCP1, IL1β, IL6, and IL8), metabolic factors (insulin, glucose, lipids, hs-CRP), and telomere length in peripheral blood mononuclear cells.
RESULTS


From 2013 to 2015, 96 women were enrolled, and 87 were evaluable for the primary analysis; 45 to POWER-remote and 42 to self-directed. At 6 months, 51% of women randomized to POWER-remote lost ≥5% of their baseline body weight, compared with 12% in the self-directed arm [OR, 7.9; 95% confidence interval (CI), 2.6-23.9;  P  = 0.0003]; proportion were similar at 12 months (51% vs 17%, respectively,  P  = 0.003). Weight loss correlated with significant decreases in leptin, and favorable modulation of inflammatory cytokines and lipid profiles. There was no significant change in telomere length at 6 months.
CONCLUSIONS


A remotely delivered weight loss intervention resulted in significant weight loss in breast cancer survivors, and favorable effects on several biomarkers.",2020,"A remotely-delivered weight loss intervention resulted in significant weight loss in breast cancer survivors, and favorable effects on several biomarkers.","['breast cancer survivors', 'Women with stage 0-III breast cancer, who completed local therapy and chemotherapy, with a body mass index ≥25 kg/m 2', 'From 2013-2015', '96 women were enrolled, and 87 were evaluable for the primary analysis; 45 to POWER-remote and 42 to self-directed', 'Breast Cancer Survivors']","['Remote-Based Weight Loss Program', 'remotely-delivered weight loss intervention (POWER-remote) or a self-directed approach', '12-month intervention (POWER-remote) versus a self-directed approach', 'weight loss intervention']","['panel of adipocytokines (adiponectin, leptin, resistin, HGF, NGF, PAI1, TNFα, MCP1, IL1β, IL6, and IL8), metabolic factors (insulin, glucose, lipids, hs-CRP), and telomere length in peripheral blood mononuclear cells', 'Adipocytokines, Metabolic Markers, and Telomere Length', 'weight loss', 'leptin, and favorable modulation of inflammatory cytokines and lipid profiles', 'biomarkers of cancer risk including metabolism, inflammation, and telomere length', 'Weight loss', 'telomere length', 'number of women who achieved at least 5% weight loss']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0441763', 'cui_str': 'Stage 0 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}]","[{'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0963992', 'cui_str': 'Adipocyte Cysteine-Rich Secreted Protein FIZZ3'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0085187'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker (substance)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",96.0,0.0691854,"A remotely-delivered weight loss intervention resulted in significant weight loss in breast cancer survivors, and favorable effects on several biomarkers.","[{'ForeName': 'Cesar A', 'Initials': 'CA', 'LastName': 'Santa-Maria', 'Affiliation': 'Department of Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Janelle W', 'Initials': 'JW', 'LastName': 'Coughlin', 'Affiliation': 'Department of Psychiatry, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Dipali', 'Initials': 'D', 'LastName': 'Sharma', 'Affiliation': 'Department of Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Armanios', 'Affiliation': 'Department of Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Blackford', 'Affiliation': 'Department of Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Schreyer', 'Affiliation': 'Department of Psychiatry, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Dalcin', 'Affiliation': 'The Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Carpenter', 'Affiliation': 'Department of Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Gerald J', 'Initials': 'GJ', 'LastName': 'Jerome', 'Affiliation': 'Division of General Internal Medicine, The Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Deborah K', 'Initials': 'DK', 'LastName': 'Armstrong', 'Affiliation': 'Department of Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Madhu', 'Initials': 'M', 'LastName': 'Chaudhry', 'Affiliation': 'Greater Baltimore Medical Center, Baltimore, Maryland.'}, {'ForeName': 'Gary I', 'Initials': 'GI', 'LastName': 'Cohen', 'Affiliation': 'Greater Baltimore Medical Center, Baltimore, Maryland.'}, {'ForeName': 'Roisin M', 'Initials': 'RM', 'LastName': 'Connolly', 'Affiliation': 'Department of Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Fetting', 'Affiliation': 'Department of Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Miller', 'Affiliation': 'Department of Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Smith', 'Affiliation': 'Department of Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Snyder', 'Affiliation': 'Department of Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wolfe', 'Affiliation': 'Department of Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Wolff', 'Affiliation': 'Department of Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Chiung-Yu', 'Initials': 'CY', 'LastName': 'Huang', 'Affiliation': 'Department of Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'Department of Psychiatry, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Vered', 'Initials': 'V', 'LastName': 'Stearns', 'Affiliation': 'Department of Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland. vstearn1@jhmi.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-2935']
484,32239322,Efficacy and safety of pirfenidone in systemic sclerosis-related interstitial lung disease-a randomised controlled trial.,"To assess the efficacy and safety of pirfenidone in systemic sclerosis-related interstitial lung disease (SSc-ILD). This was a double-blind, randomised, placebo-controlled, pilot study. Subjects with SSc-ILD and forced vital capacity (FVC) between 50 and 80% of the predicted (%pred) value were randomised in 1:1 ratio to receive either pirfenidone (2400 mg/day) or placebo for 6 months. Primary outcome was the proportion of subjects with either stabilisation or improvement in FVC at 6 months. Secondary outcomes were the absolute change in the %pred FVC, Mahler's dyspnoea index, 6-min walk distance (6MWD), modified Rodnan skin score (MRSS) and serum levels of tumour necrosis factor α (TNF-α) and transforming growth factor β (TGF-β). Thirty-four subjects with median (range) age of 41 (20-63) years (91.2% women) and median (range) %pred FVC of 65 (51-78) were enrolled. Stabilisation/improvement in FVC was seen in 16 (94.1%) and 13 (76.5%) subjects in the pirfenidone and placebo groups, respectively (p = 0.33). The median (range) absolute change in %pred FVC was - 0.55 (- 9 to 7%) and 1.0 (- 42 to 11.5%) in the treatment and control groups, respectively (p = 0.51). The changes in 6MWD, dyspnoea scores, MRSS, and levels of TNF-α and TGF-β were not significantly different between groups. Common adverse events were gastrointestinal disturbances and skin rash. We failed to find a significant beneficial effect of pirfenidone over placebo in improving/stabilising FVC, exercise capacity, symptoms, or skin disease. Study is underpowered to provide conclusive evidence. Larger studies with longer follow-up periods are required.",2020,"We failed to find a significant beneficial effect of pirfenidone over placebo in improving/stabilising FVC, exercise capacity, symptoms, or skin disease.","['Thirty-four subjects with median (range) age of 41 (20-63) years (91.2% women) and median (range) %pred FVC of 65 (51-78) were enrolled', 'systemic sclerosis-related interstitial lung disease', 'systemic sclerosis-related interstitial lung disease (SSc-ILD', 'Subjects with SSc-ILD and forced vital capacity (FVC) between 50 and 80% of the predicted (%pred) value']","['pirfenidone', 'pirfenidone over placebo', 'placebo']","['stabilising FVC, exercise capacity, symptoms, or skin disease', 'proportion of subjects with either stabilisation or improvement in FVC', 'median (range) absolute change in %pred FVC', '6MWD, dyspnoea scores, MRSS, and levels of TNF-α and TGF-β', 'efficacy and safety', 'gastrointestinal disturbances and skin rash', ""absolute change in the %pred FVC, Mahler's dyspnoea index, 6-min walk distance (6MWD), modified Rodnan skin score (MRSS) and serum levels of tumour necrosis factor α (TNF-α) and transforming growth factor β (TGF-β"", 'Efficacy and safety', 'FVC']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]","[{'cui': 'C0298067', 'cui_str': 'pirfenidone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037274', 'cui_str': 'Disorder of skin'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1845861', 'cui_str': 'X-linked intellectual disability Cabezas type'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0232459', 'cui_str': 'Abnormal digestive tract function'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C4728203', 'cui_str': 'Modified Rodnan skin score'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}]",34.0,0.234132,"We failed to find a significant beneficial effect of pirfenidone over placebo in improving/stabilising FVC, exercise capacity, symptoms, or skin disease.","[{'ForeName': 'Nupoor', 'Initials': 'N', 'LastName': 'Acharya', 'Affiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Shefali Khanna', 'Initials': 'SK', 'LastName': 'Sharma', 'Affiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh, India. shefalisania@gmail.com.'}, {'ForeName': 'Debashish', 'Initials': 'D', 'LastName': 'Mishra', 'Affiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Sahajal', 'Initials': 'S', 'LastName': 'Dhooria', 'Affiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Varun', 'Initials': 'V', 'LastName': 'Dhir', 'Affiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}]",Rheumatology international,['10.1007/s00296-020-04565-w']
485,32271671,Patient-Reported Cognitive Impairment Among Women With Early Breast Cancer Randomly Assigned to Endocrine Therapy Alone Versus Chemoendocrine Therapy: Results From TAILORx.,"PURPOSE


Cancer-related cognitive impairment (CRCI) is common during adjuvant chemotherapy and may persist. TAILORx provided a novel opportunity to prospectively assess patient-reported cognitive impairment among women with early breast cancer who were randomly assigned to chemoendocrine therapy (CT+E) versus endocrine therapy alone (E), allowing us to quantify the unique contribution of chemotherapy to CRCI.
METHODS


Women with a 21-gene recurrence score of 11 to 25 enrolled in TAILORX were randomly assigned to CT+E or E. Cognitive impairment was assessed among a subgroup of 552 evaluable women using the 37-item Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) questionnaire, administered at baseline, 3, 6, 12, 24, and 36 months. The FACT-Cog included the 20-item Perceived Cognitive Impairment (PCI) scale, our primary end point. Clinically meaningful changes were defined a priori and linear regression was used to model PCI scores on baseline PCI, treatment, and other factors.
RESULTS


FACT-Cog PCI scores were significantly lower, indicating more impairment, at 3, 6, 12, 24, and 36 months compared with baseline for both groups. The magnitude of PCI change scores was greater for CT+E than E at 3 months, the prespecified primary trial end point, and at 6 months, but not at 12, 24, and 36 months. Tests of an interaction between menopausal status and treatment were nonsignificant.
CONCLUSION


Adjuvant CT+E is associated with significantly greater CRCI compared with E at 3 and 6 months. These differences abated over time, with no significant differences observed at 12 months and beyond. These findings indicate that chemotherapy produces early, but not sustained, cognitive impairment relative to E, providing reassurance to patients and clinicians in whom adjuvant chemotherapy is indicated to reduce recurrence risk.",2020,"RESULTS


FACT-Cog PCI scores were significantly lower, indicating more impairment, at 3, 6, 12, 24, and 36 months compared with baseline for both groups.","['Women', '552 evaluable women using the', 'women with early breast cancer', 'Women with a 21-gene recurrence score of 11 to 25 enrolled in TAILORX']","['37-item Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) questionnaire', 'chemoendocrine therapy (CT+E) versus endocrine therapy alone (E', 'Endocrine Therapy', 'Chemoendocrine Therapy', 'Adjuvant CT+E', 'CT+E', 'TAILORx']","['FACT-Cog PCI scores', '20-item Perceived Cognitive Impairment (PCI) scale', 'Cognitive Impairment', 'PCI change scores', 'CRCI']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]",552.0,0.0961332,"RESULTS


FACT-Cog PCI scores were significantly lower, indicating more impairment, at 3, 6, 12, 24, and 36 months compared with baseline for both groups.","[{'ForeName': 'Lynne I', 'Initials': 'LI', 'LastName': 'Wagner', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Gray', 'Affiliation': 'ECOG-ACRIN Cancer Research Group Biostatistics Center, Boston, MA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Sparano', 'Affiliation': 'Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Whelan', 'Affiliation': 'McMaster University, Canadian Cancer Trials Group, Hamilton, Ontario, Canada.'}, {'ForeName': 'Sofia F', 'Initials': 'SF', 'LastName': 'Garcia', 'Affiliation': 'Northwestern University School of Medicine, Chicago, IL.'}, {'ForeName': 'Betina', 'Initials': 'B', 'LastName': 'Yanez', 'Affiliation': 'Northwestern University School of Medicine, Chicago, IL.'}, {'ForeName': 'Amye J', 'Initials': 'AJ', 'LastName': 'Tevaarwerk', 'Affiliation': 'University of Wisconsin Madison, Carbone Cancer Center, Madison, WI.'}, {'ForeName': 'Ruth C', 'Initials': 'RC', 'LastName': 'Carlos', 'Affiliation': 'The University of Michigan Rogel Cancer Center, Ann Arbor, MI.'}, {'ForeName': 'Kathy S', 'Initials': 'KS', 'LastName': 'Albain', 'Affiliation': 'Loyola University Chicago Stritch School of Medicine, Maywood, IL.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Olson', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Goetz', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Kathleen I', 'Initials': 'KI', 'LastName': 'Pritchard', 'Affiliation': 'Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hayes', 'Affiliation': 'The University of Michigan Rogel Cancer Center, Ann Arbor, MI.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Geyer', 'Affiliation': 'Virginia Commonwealth University Massey Cancer Center Minority/Underserved National Cancer Institute Community Oncology Research Program, Richmond, VA.'}, {'ForeName': 'E Claire', 'Initials': 'EC', 'LastName': 'Dees', 'Affiliation': 'University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Worta J', 'Initials': 'WJ', 'LastName': 'McCaskill-Stevens', 'Affiliation': 'National Cancer Institute, Rockville, MD.'}, {'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Minasian', 'Affiliation': 'National Cancer Institute, Rockville, MD.'}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Sledge', 'Affiliation': 'Stanford University, Stanford, CA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Northwestern University School of Medicine, Chicago, IL.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01866']
486,31818537,Minimally invasive surfactant therapy versus intubation for surfactant administration in very low birth weight infants with respiratory distress syndrome.,"BACKGROUND


Minimally invasive surfactant therapy (MIST) is a new mode of surfactant administration without intubation to spontaneously breathing preterm infants with respiratory distress syndrome (RDS). The aims of this study were to assess the feasibility, efficacy and safety of using MIST to give surfactant for very low birth weight (VLBW) infants with RDS.
METHODS


In total, 53 VLBW infants who were born before 32 gestational weeks with spontaneous breathing, respiratory distress, and requiring surfactant therapy were divided into two groups. The infants in group A (n = 29) were intubated and received surfactant replacement therapy via endotracheal tube, followed by mechanical ventilation (MV). The infants in group B (n = 24) received tracheal instillation of surfactant via a semirigid vascular catheter during spontaneous breathing under nasal continuous positive airway pressure (nCPAP). After surfactant instillation, the infants in group B were still placed on nCPAP.
RESULTS


Our data showed that infants in group B (MIST group) had significantly lower rate (P < 0.05) of composite outcome of death or bronchopulmonary dysplasia (BPD), duration of intermittent positive airway pressure ventilation (IPPV) or MV, drug treatment of patent ductus arteriosus (PDA), and surgical ligation of PDA than group A.
CONCLUSION


MIST is feasible, safe and it may reduce the composite outcome of death or BPD for VLBW infants with RDS requiring surfactant replacement therapy.",2020,"Our data showed that infants in group B (MIST group) had significantly lower rate (P < 0.05) of composite outcome of death or bronchopulmonary dysplasia (BPD), duration of intermittent positive airway pressure ventilation (IPPV) or MV, drug treatment of patent ductus arteriosus (PDA), and surgical ligation of PDA than group A.
CONCLUSION


MIST is feasible, safe and it may reduce the composite outcome of death or BPD for VLBW infants with RDS requiring surfactant replacement therapy.","['53 VLBW infants who were born before 32 gestational weeks with spontaneous breathing, respiratory distress, and requiring surfactant therapy', 'VLBW infants with RDS requiring surfactant replacement therapy', 'very low birth weight (VLBW) infants with RDS', 'spontaneously breathing preterm infants with respiratory distress syndrome (RDS', 'very low birth weight infants with respiratory distress syndrome']","['surfactant replacement therapy via endotracheal tube, followed by mechanical ventilation (MV', 'MIST', 'Minimally invasive surfactant therapy', 'tracheal instillation of surfactant via a semirigid vascular catheter during spontaneous breathing under nasal continuous positive airway pressure (nCPAP', 'invasive surfactant therapy (MIST']","['death or bronchopulmonary dysplasia (BPD), duration of intermittent positive airway pressure ventilation (IPPV) or MV, drug treatment of patent ductus arteriosus (PDA), and surgical ligation of PDA', 'feasibility, efficacy and safety']","[{'cui': 'C0282667', 'cui_str': 'Very low birth weight infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C3661922', 'cui_str': 'Surfactant replacement therapy'}, {'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C3661922', 'cui_str': 'Surfactant replacement therapy'}, {'cui': 'C0442465', 'cui_str': 'Via endotracheal tube'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2945595', 'cui_str': 'Tracheal'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}, {'cui': 'C0441134', 'cui_str': 'Vascular catheter'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C1258045', 'cui_str': 'nCPAP Ventilation'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0190671', 'cui_str': 'Ligation of patent ductus arteriosus'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",53.0,0.0503231,"Our data showed that infants in group B (MIST group) had significantly lower rate (P < 0.05) of composite outcome of death or bronchopulmonary dysplasia (BPD), duration of intermittent positive airway pressure ventilation (IPPV) or MV, drug treatment of patent ductus arteriosus (PDA), and surgical ligation of PDA than group A.
CONCLUSION


MIST is feasible, safe and it may reduce the composite outcome of death or BPD for VLBW infants with RDS requiring surfactant replacement therapy.","[{'ForeName': 'Xing-An', 'Initials': 'XA', 'LastName': 'Wang', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Chung-Shan Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Lih-Ju', 'Initials': 'LJ', 'LastName': 'Chen', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Changhua Christian Children's Hospital, Changhua City, Taiwan; Institute of Medicine, Chung-Shan Medical University, Taichung, Taiwan.""}, {'ForeName': 'Shan-Ming', 'Initials': 'SM', 'LastName': 'Chen', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Chung-Shan Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Pen-Hua', 'Initials': 'PH', 'LastName': 'Su', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Chung-Shan Medical University Hospital, Taichung, Taiwan; Institute of Medicine, Chung-Shan Medical University, Taichung, Taiwan.'}, {'ForeName': 'Jia-Yuh', 'Initials': 'JY', 'LastName': 'Chen', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Changhua Christian Children's Hospital, Changhua City, Taiwan; Institute of Medicine, Chung-Shan Medical University, Taichung, Taiwan. Electronic address: 182288@cch.org.tw.""}]",Pediatrics and neonatology,['10.1016/j.pedneo.2019.11.002']
487,31438863,"The effect of circuit resistance training, empagliflozin or ""vegeterranean diet"" on physical and metabolic function in older subjects with type 2 diabetes: a study protocol for a randomized control trial (CEV-65 trial).","BACKGROUND


Treatment of the older diabetic individual comprises a therapeutic challenge. Currently little scientific evidence exists depicting the best approach to type 2 diabetes treatment in this growing sub-population of patients. The purpose of this study is to assess the effects of a modified plant-based Mediterranean diet (""vegeterranean"" diet), circuit resistance training (CRT) and empagliflozin, separately or in combination, on body composition and physical function in older subjects with type 2 diabetes. The rationale for this study is to assess three interventions associated with a negative energy/caloric balance (increased caloric use in exercise, caloric restriction in the ""vegeterranean"" diet and caloric wasting by glycosuria with empagliflozin), their interaction and effect on body composition and physical function.
METHODS


One hundred and twenty men and women ≥65 years of age with type 2 diabetes, and low levels of physical activity will be randomized (1:1:1 manner, gender stratified) for 10 weeks to one of 3 parallel arms: CRT consisting of 3 home sessions/week; ad-libitum plant-based Mediterranean diet (limited consumption of eggs, dairy and fish, avoidance of red meat and poultry) or empagliflozin 10 mg/day. After 10 weeks CRT will be added to the empagliflozin and diet arms for an additional 10 weeks. Allocation concealment and blinding of primary outcome assessors will be implemented. Efficacy will be determined by assessment of lean body mass, body weight, frailty and functional status, sarcopenia, HbA1c and quality of life questionnaires. Safety will be evaluated by routine monitoring of adverse events. This study was approved by the Tel-Aviv Sourasky Medical Center Institutional Review Board.
DISCUSSION


The combination and comparison of these diverse interventions to metabolic control may lead to better understanding of their mechanism of action with potential clinical implications in older individuals. Also, this study will provide evidence of the effectiveness of these interventions on delaying the progression from diabetes to sarcopenia and/or frailty.
TRIAL REGISTRATION


ClinicalTrials.gov PRS: NCT03560375 . Last registration date (last update): 06/06/2018. The trial was a-priori registered before actual recruitment of subjects.",2019,"Efficacy will be determined by assessment of lean body mass, body weight, frailty and functional status, sarcopenia, HbA1c and quality of life questionnaires.","['older subjects with type 2 diabetes', 'older individuals', 'One hundred and twenty men and women ≥65\u2009years of age with type 2 diabetes, and low levels of physical activity']","['empagliflozin', 'libitum plant-based Mediterranean diet (limited consumption of eggs, dairy and fish, avoidance of red meat and poultry) or empagliflozin', 'circuit resistance training, empagliflozin or ""vegeterranean diet', 'modified plant-based Mediterranean diet (""vegeterranean"" diet), circuit resistance training (CRT) and empagliflozin']","['lean body mass, body weight, frailty and functional status, sarcopenia, HbA1c and quality of life questionnaires', 'physical and metabolic function', 'body composition and physical function']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032098', 'cui_str': 'Plants'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0029974', 'cui_str': 'Egg, Unfertilized'}, {'cui': 'C0016163', 'cui_str': 'Fishes'}, {'cui': 'C0452848', 'cui_str': 'Red Meat'}, {'cui': 'C0452888', 'cui_str': 'Poultry (substance)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenias'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}]",120.0,0.072851,"Efficacy will be determined by assessment of lean body mass, body weight, frailty and functional status, sarcopenia, HbA1c and quality of life questionnaires.","[{'ForeName': 'Assaf', 'Initials': 'A', 'LastName': 'Buch', 'Affiliation': 'Institute of Endocrinology, Metabolism and Hypertension, Tel Aviv Sourasky Medical Center, Tel-Aviv, Israel. buchasaf@gmail.com.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Eldor', 'Affiliation': 'Institute of Endocrinology, Metabolism and Hypertension, Tel Aviv Sourasky Medical Center, Tel-Aviv, Israel.'}, {'ForeName': 'Ofer', 'Initials': 'O', 'LastName': 'Kis', 'Affiliation': 'Institute of Endocrinology, Metabolism and Hypertension, Tel Aviv Sourasky Medical Center, Tel-Aviv, Israel.'}, {'ForeName': 'Lital', 'Initials': 'L', 'LastName': 'Keinan-Boker', 'Affiliation': 'School of Public Health, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Ayelet', 'Initials': 'A', 'LastName': 'Dunsky', 'Affiliation': 'The Academic College at Wingate, Wingate Institute, Netanya, Israel.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Rubin', 'Affiliation': 'The Academic College at Wingate, Wingate Institute, Netanya, Israel.'}, {'ForeName': 'Adar', 'Initials': 'A', 'LastName': 'Lopez', 'Affiliation': 'School of Public Health, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Sofer', 'Affiliation': 'Institute of Endocrinology, Metabolism and Hypertension, Tel Aviv Sourasky Medical Center, Tel-Aviv, Israel.'}, {'ForeName': 'Etty', 'Initials': 'E', 'LastName': 'Osher', 'Affiliation': 'Institute of Endocrinology, Metabolism and Hypertension, Tel Aviv Sourasky Medical Center, Tel-Aviv, Israel.'}, {'ForeName': 'Yonit', 'Initials': 'Y', 'LastName': 'Marcus', 'Affiliation': 'Institute of Endocrinology, Metabolism and Hypertension, Tel Aviv Sourasky Medical Center, Tel-Aviv, Israel.'}, {'ForeName': 'Naftali', 'Initials': 'N', 'LastName': 'Stern', 'Affiliation': 'Institute of Endocrinology, Metabolism and Hypertension, Tel Aviv Sourasky Medical Center, Tel-Aviv, Israel.'}]",BMC geriatrics,['10.1186/s12877-019-1219-7']
488,32268592,Effects of Regular Taekwondo Intervention on Oxidative Stress Biomarkers and Myokines in Overweight and Obese Adolescents.,"Purpose : Regular exercise can alleviate oxidative stress related to obesity and can induce secretion of myokines that are involved in the regulation of metabolic homeostasis. There are no studies examining changes in these variables as a result of Taekwondo training intervention. We aimed to investigate the effect of Taekwondo training on oxidative stress and myokine levels in overweight and obese adolescents.  Methods:  We randomly assigned 20 overweight and obese adolescents to control (control group; CG, n = 10) and experimental (experimental group; EG, n = 10) groups. The EG performed Taekwondo training five times a week for 16 weeks. Physical parameters (height, weight, body mass index (BMI)), physical fitness (maximal oxygen uptake (VO 2 max) (cardiorespiratory endurance), grip and leg strength (muscular strength), sit-and-reach (flexibility), Sargent jump (power), and stork stand test (balance)) were measured before and after intervention. We measured levels of serum oxidative stress markers (plasma malondialdehyde (MDA) and superoxide dismutase (SOD)) and myokines (serum interleukin-15 (IL-15), brain-derived neurotrophic factor (BDNF), irisin, and myostatin).  Results:  The weight and BMI in the EG after intervention were significantly lower and leg strength (muscular strength), sit-and-reach (flexibility), and Sargent jump (power) were significantly improved compared to those of the CG ( p <  0.05). There were no significant interaction effects in terms of height, VO 2  max, grip strength, or stork stand test ( p >  0.05). The SOD and BDNF level after intervention were significantly higher in the EG after the intervention, whereas MDA and irisin levels were significantly lower than those of the CG ( p <  0.05). There were no significant interaction effects in terms of serum IL-15 and myostatin levels ( p >  0.05).  Conclusions:  Taekwondo training can reduce obesity and increase physical fitness with respect to muscular strength, flexibility, and power as well as alleviate oxidative stress and modulate myokine secretion in adolescents.",2020,"There were no significant interaction effects in terms of height, VO 2  max, grip strength, or stork stand test ( p >  0.05).","['Overweight and Obese Adolescents', '20 overweight and obese adolescents to', 'overweight and obese adolescents', 'adolescents']","['Taekwondo training', 'control (control group; CG', 'Regular Taekwondo Intervention']","['oxidative stress and myokine levels', 'serum oxidative stress markers (plasma malondialdehyde (MDA) and superoxide dismutase (SOD)) and myokines (serum interleukin-15 (IL-15), brain-derived neurotrophic factor (BDNF), irisin, and myostatin', 'height, VO 2  max, grip strength, or stork stand test', 'MDA and irisin levels', 'Oxidative Stress Biomarkers and Myokines', 'SOD and BDNF level', 'Physical parameters (height, weight, body mass index (BMI)), physical fitness (maximal oxygen uptake (VO 2 max) (cardiorespiratory endurance), grip and leg strength (muscular strength), sit-and-reach (flexibility), Sargent jump (power), and stork stand test (balance', 'leg strength (muscular strength), sit-and-reach (flexibility), and Sargent jump (power', 'weight and BMI', 'serum IL-15 and myostatin levels']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0254610', 'cui_str': 'Interleukin 15'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0538238', 'cui_str': 'GDF8 protein, human'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0325459', 'cui_str': 'Stork'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",20.0,0.010736,"There were no significant interaction effects in terms of height, VO 2  max, grip strength, or stork stand test ( p >  0.05).","[{'ForeName': 'Hee-Tae', 'Initials': 'HT', 'LastName': 'Roh', 'Affiliation': 'Department of Physical Education, College of Arts and Physical Education, Dong-A University, Busan 49315, Korea.'}, {'ForeName': 'Su-Youn', 'Initials': 'SY', 'LastName': 'Cho', 'Affiliation': 'Department of Taekwondo, Youngsan University, Yangsan-si 50510, Korea.'}, {'ForeName': 'Wi-Young', 'Initials': 'WY', 'LastName': 'So', 'Affiliation': 'Sports and Health Care Major, College of Humanities and Arts, Korea National University of Transportation, Chungju-si 27469, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17072505']
489,32268601,Effects of Brain Breaks Videos on the Motives for the Physical Activity of Malaysians with Type-2 Diabetes Mellitus.,"Brain Breaks videos are web-based structured physical activity (PA) videos that aim at stimulating an interest in learning and promoting health. Exercise is one of the important treatment regimens for people with type 2 diabetes mellitus (T2DM). Thus, the objective of this study was to determine the effects that Brain Breaks videos have on the motives for PA, as measured by the Physical Activity and Leisure Motivation Scale-Malay (PALMS-M), and the amount of PA, as measured by the International Physical Activity Questionnaire-Malay (IPAQ-M), in T2DM patients (the most common type of diabetes mellitus patients). This study was conducted using a randomized, double-blind design and grouped subjects under two research conditions: an experimental group given Brain Breaks videos and a control group. Purposive sampling was employed to recruit 70 T2DM patients (male = 39, female = 31) with the mean age of 57.6 (SD = 8.5) from Hospital Universiti Sains Malaysia, Kelantan. Over a four-month period, the participants in the experimental group were asked to perform PA daily based on a Brain Breaks video (10 min in duration) that was shared through a WhatsApp group. All participants from both groups answered the PALMS-M questionnaire five times: pre-intervention, the end of the first month, second month, and third month, and post-intervention. A repeated measure multivariate analysis of variance and a repeated measure analysis of variance were performed for the analyses of the data. The results demonstrated that four (appearance, others' expectations, physical condition, and mastery) out of eight motives for PA produced a significant mean score difference between the two study groups. All eight motives for PA showed an upward trend for the experimental group during the study period, while the control group showed a downward trend for all motives during the study period. As for the amount of PA, both groups showed significant differences ( p  = 0.001). The amount of PA increased in the experimental group during the study period, while it decreased in the control group. Therefore, Brain Breaks videos can be considered as an effective intervention for motivating T2DM patients for PA and improving their amount of PA.",2020,"As for the amount of PA, both groups showed significant differences ( p  = 0.001).","['70 T2DM patients (male = 39, female = 31) with the mean age of 57.6 (SD = 8.5) from Hospital Universiti Sains Malaysia, Kelantan', 'Malaysians with Type-2 Diabetes Mellitus', 'people with type 2 diabetes mellitus (T2DM']","['Brain Breaks Videos', 'PA daily based on a Brain Breaks video']","['amount of PA', 'Physical Activity and Leisure Motivation Scale-Malay (PALMS-M), and the amount of PA, as measured by the International Physical Activity Questionnaire-Malay (IPAQ-M']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0024549', 'cui_str': 'Malay language'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",70.0,0.0236696,"As for the amount of PA, both groups showed significant differences ( p  = 0.001).","[{'ForeName': 'Aizuddin', 'Initials': 'A', 'LastName': 'Hidrus', 'Affiliation': 'Unit of Biostatistics and Research Methodology, School of Medical Sciences, Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan, Malaysia.'}, {'ForeName': 'Yee Cheng', 'Initials': 'YC', 'LastName': 'Kueh', 'Affiliation': 'Unit of Biostatistics and Research Methodology, School of Medical Sciences, Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan, Malaysia.'}, {'ForeName': 'Bachok', 'Initials': 'B', 'LastName': 'Norsaádah', 'Affiliation': 'Unit of Biostatistics and Research Methodology, School of Medical Sciences, Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan, Malaysia.'}, {'ForeName': 'Yu-Kai', 'Initials': 'YK', 'LastName': 'Chang', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei 24449, Taiwan.'}, {'ForeName': 'Tsung-Min', 'Initials': 'TM', 'LastName': 'Hung', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei 24449, Taiwan.'}, {'ForeName': 'Nyi Nyi', 'Initials': 'NN', 'LastName': 'Naing', 'Affiliation': 'Faculty of Medicine, Universiti Sultan Zainal Abidin, Medical Campus, Jalan Sultan Mahmud, 20400 Kuala Terengganu, Terengganu, Malaysia.'}, {'ForeName': 'Garry', 'Initials': 'G', 'LastName': 'Kuan', 'Affiliation': 'Exercise and Sports Science Programme, School of Health Sciences, Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan, Malaysia.'}]",International journal of environmental research and public health,['10.3390/ijerph17072507']
490,30267045,Effect of Foster Care Intervention on Trajectories of General and Specific Psychopathology Among Children With Histories of Institutional Rearing: A Randomized Clinical Trial.,"Importance


It is unclear whether early institutional rearing is associated with more problematic trajectories of psychopathology from childhood to adolescence and whether assignment to foster care mitigates this risk.
Objectives


To examine trajectories of latent psychopathology factors-general (P), internalizing (INT), and externalizing (EXT)-among children reared in institutions and to evaluate whether randomization to foster care is associated with reductions in psychopathology from middle childhood through adolescence.
Design, Setting, and Participants


This longitudinal, intent-to-treat randomized clinical trial was conducted in Bucharest, Romania, where children residing in 6 institutions underwent baseline testing and were then randomly assigned to a care as usual group (CAUG) or a foster care group (FCG). A matched sample of a never-institutionalized group (NIG) was recruited to serve as a comparison group. The study commenced in April 2001, and the most recent (age 16 years) follow-up started in January 2015 and is ongoing.
Intervention


Institutionally reared children randomized to high-quality foster homes.
Main Outcomes and Measures


Psychopathology was measured using the MacArthur Health and Behavior Questionnaire. Teachers and/or caregivers reported on symptoms of psychopathology in several domains.
Results


A total of 220 children (50.0% female; 119 ever institutionalized) were included in the analysis at the mean ages of 8, 12, and 16 years. A latent bifactor model with general (P) and specific internalizing (INT) and externalizing (EXT) factors offered a good fit to the data. At age 8 years, CAUG (mean, 0.41; 95% CI, 0.17-0.67) and FCG (mean, 0.30; 95% CI, 0.04-0.53) had higher P than NIG (mean, -0.40; 95% CI, -0.56 to -0.18). By age 16 years, FCG (mean, 0.07; 95% CI, -0.18 to 0.29) had lower P than CAUG (mean, 0.37; 95% CI, 0.13-0.60). This effect was likely driven by modest declines in P from age 8 years to age 16 years among FCG (slope, -0.12; 95% CI, -0.26 to 0.04) compared with CAUG, who remained stably high over this period (slope, -0.02; 95% CI, -0.19 to 0.14). Moreover, CAUG and FCG showed increasing divergence in EXT over time, such that FCG (mean, -0.30; 95% CI, -0.58 to -0.02) had fewer problems than CAUG (mean, 0.05; 95% CI, -0.25 to 0.36) by age 16 years. No INT differences were observed.
Conclusions and Relevance


Institutionalization increases transdiagnostic vulnerability to psychopathology from childhood to adolescence, a period of significant social and biological change. Early assignment to foster care partially mitigates this risk, thus highlighting the importance of social enrichment in buffering the effects of severe early neglect on trajectories of psychopathology.
Trial Registration


ClinicalTrials.gov Identifier: NCT00747396.",2018,"By age 16 years, FCG (mean, 0.07; 95% CI, -0.18 to 0.29) had lower P than CAUG (mean, 0.37; 95% CI, 0.13-0.60).","['With Histories of Institutional Rearing', '220 children (50.0% female; 119 ever institutionalized) were included in the analysis at the mean ages of 8, 12, and 16 years', 'April 2001, and the most recent (age 16 years) follow-up started in January 2015 and is ongoing', 'A matched sample of a never-institutionalized group (NIG', 'Bucharest, Romania, where children residing in 6 institutions underwent baseline testing', 'Children']","['care as usual group (CAUG) or a foster care group (FCG', 'Foster Care Intervention']","['specific internalizing (INT) and externalizing (EXT) factors', 'Trajectories of General and Specific Psychopathology', 'MacArthur Health and Behavior Questionnaire', 'Measures\n\n\nPsychopathology', 'FCG', 'latent psychopathology factors-general (P), internalizing (INT), and externalizing']","[{'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0562359', 'cui_str': 'Institutionalized (finding)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0035826', 'cui_str': 'Romania'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0580718', 'cui_str': 'Foster care procedures (procedure)'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205275', 'cui_str': 'Latent (qualifier value)'}]",220.0,0.107497,"By age 16 years, FCG (mean, 0.07; 95% CI, -0.18 to 0.29) had lower P than CAUG (mean, 0.37; 95% CI, 0.13-0.60).","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wade', 'Affiliation': ""Division of Developmental Medicine, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Fox', 'Affiliation': 'Department of Human Development and Quantitative Methodology, University of Maryland, College Park.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Zeanah', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Tulane University School of Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Nelson', 'Affiliation': ""Division of Developmental Medicine, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts.""}]",JAMA psychiatry,['10.1001/jamapsychiatry.2018.2556']
491,27488098,Urinary excretion of Citrus flavanones and their major catabolites after consumption of fresh oranges and pasteurized orange juice: A randomized cross-over study.,"SCOPE


Orange juice contains flavanones including hesperidin and narirutin, albeit at lower concentrations as compared to orange fruit. Therefore, we compared bioavailability and colonic catabolism of flavanones from orange juice to a 2.4-fold higher dose from fresh oranges.
METHODS AND RESULTS


Following a randomized two-way cross-over design, 12 healthy subjects consumed a test meal comprising either fresh oranges or pasteurized orange juice, delivering 1774 and 751 μmol of total Citrus flavanones, respectively. Deglucuronidated and desulfated hesperetin, naringenin, and the flavanone catabolites 3-(3'-hydroxy-4'-methoxyphenyl)propionic acid, 3-(3'-hydroxyphenyl)hydracrylic acid, 4-hydroxyhippuric acid, and hippuric acid were quantitated in 24-h urine by UHPLC-MS/MS. Differences in urinary hesperetin excretion were found to be nonsignificant (p = 0.5209) both after consumption of orange fruit (21.6 ± 8.0 μmol) and juice (18.3 ± 7.2 μmol). By analogy, postprandial flavanone catabolite excretions were highly similar between treatments. Excretion of 3-(3'-hydroxy-4'-methoxyphenyl)propionic acid was inversely related to that of hesperetin, illustrating the catabolite/precursor relationship.
CONCLUSION


Despite 2.4-fold higher doses, excretion of flavanones from ingested fresh orange fruit did not differ from that following orange juice consumption, possibly due to a saturation of absorption or their entrapment in the fiber-rich matrix of the fruit.",2016,Differences in urinary hesperetin excretion were found to be nonsignificant (p = 0.5209) both after consumption of orange fruit (21.6 ± 8.0 μmol) and juice (18.3 ± 7.2 μmol).,['12 healthy subjects consumed a'],"['pasteurized orange juice', 'test meal comprising either fresh oranges or pasteurized orange juice']","[""Excretion of 3-(3'-hydroxy-4'-methoxyphenyl)propionic acid"", 'urinary hesperetin excretion', ""flavanone catabolites 3-(3'-hydroxy-4'-methoxyphenyl)propionic acid, 3-(3'-hydroxyphenyl)hydracrylic acid, 4-hydroxyhippuric acid, and hippuric acid"", 'Urinary excretion of Citrus flavanones', 'bioavailability and colonic catabolism', 'postprandial flavanone catabolite excretions']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0452458', 'cui_str': 'Orange juice'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C0440277', 'cui_str': 'Oranges'}]","[{'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0062585', 'cui_str': 'hesperetin'}, {'cui': 'C1257969', 'cui_str': 'Flavanones'}, {'cui': 'C0048349', 'cui_str': 'p-hydroxyhippuric acid'}, {'cui': 'C0062725', 'cui_str': 'hippuric acid'}, {'cui': 'C0008865', 'cui_str': 'Citrus'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0699900', 'cui_str': 'Catabolism'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}]",12.0,0.0229764,Differences in urinary hesperetin excretion were found to be nonsignificant (p = 0.5209) both after consumption of orange fruit (21.6 ± 8.0 μmol) and juice (18.3 ± 7.2 μmol).,"[{'ForeName': 'Julian K', 'Initials': 'JK', 'LastName': 'Aschoff', 'Affiliation': 'Institute of Food Science and Biotechnology, University of Hohenheim, Stuttgart, Germany.'}, {'ForeName': 'Ken M', 'Initials': 'KM', 'LastName': 'Riedl', 'Affiliation': 'Department of Food Science & Technology, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Cooperstone', 'Affiliation': 'Department of Food Science & Technology, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Högel', 'Affiliation': 'Institute of Human Genetics, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Bosy-Westphal', 'Affiliation': 'Institute of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Schwartz', 'Affiliation': 'Department of Food Science & Technology, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Reinhold', 'Initials': 'R', 'LastName': 'Carle', 'Affiliation': 'Institute of Food Science and Biotechnology, University of Hohenheim, Stuttgart, Germany.'}, {'ForeName': 'Ralf M', 'Initials': 'RM', 'LastName': 'Schweiggert', 'Affiliation': 'Institute of Food Science and Biotechnology, University of Hohenheim, Stuttgart, Germany.'}]",Molecular nutrition & food research,['10.1002/mnfr.201600315']
492,32278674,"Comparative Efficacy of Bortezomib, Melphalan, and Prednisone (VMP) With or Without Daratumumab Versus VMP Alone in the Treatment of Newly Diagnosed Multiple Myeloma: Propensity Score Matching of ALCYONE and VISTA Phase III Studies.","INTRODUCTION


Bortezomib, melphalan, and prednisone (VMP) is the standard of care for transplant-ineligible newly diagnosed multiple myeloma. The phase III VISTA trial established the bortezomib dosing schedule for VMP. To mitigate bortezomib-associated toxicity, the phase III ALCYONE study of daratumumab plus VMP (D-VMP) versus VMP used modified bortezomib dosing. D-VMP demonstrated improved progression-free survival and overall response rate. Propensity score matching enables indirect comparisons by controlling for differences in baseline covariates.
PATIENTS AND METHODS


The efficacy and safety of both arms of ALCYONE were compared with VISTA VMP using propensity score matching. ALCYONE D-VMP and VMP patients were matched on selected baseline characteristics to VISTA VMP patients, reducing or eliminating systematic differences between treatment groups.
RESULTS


After matching, median progression-free survival and overall response rate were comparable for ALCYONE VMP and VISTA VMP, and were significantly improved with ALCYONE D-VMP versus VISTA VMP. Rates of grade 3/4 peripheral sensory neuropathy were significantly lower for both arms of ALCYONE versus VISTA VMP, with or without matching.
CONCLUSION


This propensity score matching analysis demonstrates significant improvements in efficacy with ALCYONE D-VMP versus VISTA VMP and a significantly lower incidence of peripheral sensory neuropathy in both arms of ALCYONE versus VISTA VMP, although safety improvements may be due to different bortezomib administration routes (ALCYONE, subcutaneous; VISTA, intravenous).",2020,"Rates of grade 3/4 peripheral sensory neuropathy were significantly lower for both arms of ALCYONE versus VISTA VMP, with or without matching.
","['transplant-ineligible newly diagnosed multiple myeloma', 'Newly Diagnosed Multiple Myeloma']","['Bortezomib, Melphalan, and Prednisone (VMP', 'VISTA VMP', 'Without Daratumumab Versus VMP Alone', 'Bortezomib, melphalan, and prednisone (VMP', 'bortezomib']","['Rates of grade 3/4 peripheral sensory neuropathy', 'progression-free survival and overall response rate', 'median progression-free survival and overall response rate', 'efficacy and safety', 'peripheral sensory neuropathy']","[{'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}]","[{'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C2346801', 'cui_str': 'daratumumab'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0746401,"Rates of grade 3/4 peripheral sensory neuropathy were significantly lower for both arms of ALCYONE versus VISTA VMP, with or without matching.
","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': '""Seràgnoli"" Institute of Hematology Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Bologna, Italy. Electronic address: michele.cavo@unibo.it.'}, {'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'Department of Clinical Therapeutics, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'San-Miguel', 'Affiliation': 'Clínica Universidad de Navarra-CIMA, IDISNA, CIBERONC, Pamplona, Spain.'}, {'ForeName': 'Maria-Victoria', 'Initials': 'MV', 'LastName': 'Mateos', 'Affiliation': 'Cancer Research Unit, University Hospital of Salamanca, Instituto de Investigación Biomédica de Salamanca (IBSAL), Salamanca, Spain.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Jakubowiak', 'Affiliation': 'Department of Hematology and Oncology, University of Chicago Medical Center, Chicago, IL.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Deraedt', 'Affiliation': 'Janssen Research & Development, LLC, Beerse, Belgium.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Lam', 'Affiliation': 'Janssen Global Services, LLC, Raritan, NJ.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Kampfenkel', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Qi', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA.'}, {'ForeName': 'Jianming', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Janssen Global Services, LLC, Raritan, NJ.'}]","Clinical lymphoma, myeloma & leukemia",['10.1016/j.clml.2020.02.018']
493,32277531,Five-year safety and efficacy data from a phase Ib study of nivolumab and chemotherapy in advanced non-small-cell lung cancer.,"Combination antiprogrammed death 1/programmed death-ligand 1 Ab and platinum-based chemotherapy is standard first-line treatment for advanced non-small-cell lung cancer without targetable oncogene alterations. We describe the long-term safety and efficacy data from a previously reported phase Ib study of nivolumab and chemotherapy. Japanese patients with non-small-cell lung cancer were assigned to a treatment arm based on histology and treatment history. Nivolumab (10 mg/kg, i.v.) and chemotherapy (4 arms) were given every 3 weeks: arm A, 4 cycles of cisplatin and gemcitabine (first-line); arm B, 4 cycles of cisplatin and pemetrexed followed by pemetrexed maintenance therapy (first-line); arm C, 4-6 cycles of carboplatin, paclitaxel, and bevacizumab followed by bevacizumab (first-line); and arm D, docetaxel (second- or third-line). Study treatments were continued every 3 weeks as maintenance therapy until disease progression. Minimum follow-up period was 57.9 months. Median progression-free survival (median [range, plus sign indicates censored data]) was 6.3 (0.7+-47.8), 11.8 (1.4-65.1+), 40.7 (5.3-60.8+), and 3.2 (1.9-10.9) months, and 5-year progression-free survival was observed in 0/6, 1/6, 1/6, and 0/6 patients in arms A, B, C, and D, respectively. Median overall survival was 13.2 (11.0-55.4), 28.5 (14.6-66.2+), not reached (24.2-67.4+), and 12.5 (9.8-16.9) months; the number of patients surviving 5 years were 0/6, 1/6, 4/6, and 0/6 in arms A, B, C, and D, respectively. No unexpected severe adverse events or treatment-related deaths occurred. Nivolumab and platinum-based chemotherapy combinations showed long-term tolerability. A moderate proportion of patients in arm C showed 5-year progression-free and overall survival.",2020,No unexpected severe adverse events or treatment-related deaths occurred.,"['advanced non-small-cell lung cancer', 'Japanese patients with non-small-cell lung cancer']","['Nivolumab', 'Combination anti-programmed death 1/programmed death-ligand 1 antibody and platinum-based chemotherapy', 'nivolumab and chemotherapy', 'cisplatin and pemetrexed followed by pemetrexed maintenance therapy', 'chemotherapy', 'carboplatin, paclitaxel, and bevacizumab followed by bevacizumab (first-line); arm D, docetaxel (second- or third-line', 'Nivolumab and platinum-based chemotherapy combinations', 'cisplatin and gemcitabine']","['5-year progression-free and overall survival', 'severe adverse events', 'Median overall survival', '5-year progression-free survival', 'long-term tolerability', 'Median progression-free survival']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",,0.065678,No unexpected severe adverse events or treatment-related deaths occurred.,"[{'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Kanda', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Ohe', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Goto', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Hidehito', 'Initials': 'H', 'LastName': 'Horinouchi', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Respiratory Medicine, Mitsui Memorial Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nokihara', 'Affiliation': 'Department of Respiratory Medicine and Rheumatology, Graduate School of Biomedical Sciences, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Noboru', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Yamamoto', 'Affiliation': 'Oncology Clinical Development Planning 1, Ono Pharmaceutical Co. Ltd, Osaka, Japan.'}, {'ForeName': 'Tomohide', 'Initials': 'T', 'LastName': 'Tamura', 'Affiliation': ""Thoracic Center, St. Luke's International Hospital, Tokyo, Japan.""}]",Cancer science,['10.1111/cas.14410']
494,32273165,Staged horizontal bone augmentation for dental implants in aesthetic zones: A prospective randomized controlled clinical trial comparing a half-columnar bone block harvested from the ramus versus a rectangular bone block from the symphysis.,"In this study, the clinical outcomes of horizontal ridge augmentation using half-columnar bone grafts from the ramus (group I: 27 patients, 32 implants) versus rectangular bone grafts from the symphysis (group II: 19 patients, 27 implants) were compared; grafts were combined with organic bovine bone and collagen membrane. Cone beam computed tomography images were obtained preoperatively, immediately after restoration (baseline), and 1 year after loading. Four months after grafting, horizontal bone resorption at the alveolar crest did not differ significantly between the two groups (P=0.291). At 4mm apical to the alveolar crest, horizontal bone resorption in group I was significantly less than that in group II (P=0.041). One year after loading, horizontal bone resorption in group I was lower than that in group II, with no significant difference. The residual thickness of the labial bone at the implant site in group I was significantly higher than that in group II. Horizontal ridge augmentation with either a half-columnar autogenous graft from the ramus or a rectangular autogenous graft from the symphysis can provide acceptable results in aesthetic regions. The half-columnar group demonstrated better graft stability both at 4 months after augmentation and 1 year after loading.",2020,"At 4mm apical to the alveolar crest, horizontal bone resorption in group I was significantly less than that in group II (P=0.041).",['dental implants in aesthetic zones'],"['organic bovine bone and collagen membrane', 'rectangular bone grafts from the symphysis', 'Horizontal ridge augmentation with either a half-columnar autogenous graft', 'Staged horizontal bone augmentation', 'horizontal ridge augmentation using half-columnar bone grafts']","['horizontal bone resorption', 'alveolar crest, horizontal bone resorption', 'graft stability', 'residual thickness of the labial bone']","[{'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}]","[{'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0205142', 'cui_str': 'Rectangular'}, {'cui': 'C0005976', 'cui_str': 'Bone graft'}, {'cui': 'C0224520', 'cui_str': 'Symphysis structure'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0559189', 'cui_str': 'Autograft'}]","[{'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0206138', 'cui_str': 'CREST syndrome'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0023759', 'cui_str': 'Lip structure'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}]",,0.0253299,"At 4mm apical to the alveolar crest, horizontal bone resorption in group I was significantly less than that in group II (P=0.041).","[{'ForeName': 'X', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'The Second Dental Centre, Peking University School and Hospital of Stomatology, Chaoyang District, Beijing, China; National Engineering Laboratory for Digital and Material Technology of Stomatology, Peking University School and Hospital of Stomatology, Haidian District, Beijing, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zou', 'Affiliation': 'The Second Dental Centre, Peking University School and Hospital of Stomatology, Chaoyang District, Beijing, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'The Second Dental Centre, Peking University School and Hospital of Stomatology, Chaoyang District, Beijing, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Tang', 'Affiliation': 'The Second Dental Centre, Peking University School and Hospital of Stomatology, Chaoyang District, Beijing, China; National Engineering Laboratory for Digital and Material Technology of Stomatology, Peking University School and Hospital of Stomatology, Haidian District, Beijing, China. Electronic address: tang_zhihui@live.cn.'}]",International journal of oral and maxillofacial surgery,['10.1016/j.ijom.2019.12.010']
495,31960079,Is biological therapy in systemic sclerosis the answer?,"Systemic sclerosis is a systemic fibrosing disorder associated with significant morbidity and mortality, with no universally accepted disease-modifying therapy. Significant advances in the understanding of systemic sclerosis in recent years have guided the exploration of biological drugs in systemic sclerosis. In this narrative review, we summarize the published literature on biologic therapies in systemic sclerosis. A double-blind randomized trial, and an open label trial of tocilizumab (which antagonizes the interleukin 6 receptor), identified potential benefits in skin and lung fibrosis in systemic sclerosis; however, these differences failed to attain statistical significance. Two open-label trials compared rituximab (which depletes B lymphocytes) to conventional treatment/ cyclophosphamide in systemic sclerosis-associated interstitial lung disease (ILD), and revealed significant improvements in lung functions and skin disease with rituximab. Significant observational data also support the use of rituximab in skin, lung, muscle and joint manifestations of systemic sclerosis. Abatacept (which blocks T lymphocyte activation) has demonstrated utility for skin and joint disease in systemic sclerosis; a recent clinical trial failed to demonstrate benefits in improving skin thickness compared to placebo. Agents targeting type I interferons, interleukin 17 pathway, CD19 and plasma cells hold promise in systemic sclerosis; however, high-quality evidence is lacking. The results of different ongoing clinical trials targeting B lymphocytes, T lymphocytes, various cytokines (interleukins 6, 17, 4, 13, IL-1α), platelet-derived growth factor receptor, proteasome, integrins or oncostatin M may help guide future therapeutic regimens with biological agents in systemic sclerosis.",2020,Abatacept (which blocks T lymphocyte activation) has demonstrated utility for skin and joint disease in systemic sclerosis; a recent clinical trial failed to demonstrate benefits in improving skin thickness compared to placebo.,['skin and lung fibrosis in systemic sclerosis'],"['conventional treatment/ cyclophosphamide', 'Abatacept (which blocks T lymphocyte activation', 'rituximab', 'placebo', 'tocilizumab']",['skin thickness'],"[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0034069', 'cui_str': 'Pulmonary Fibrosis'}, {'cui': 'C0036421', 'cui_str': 'Systemic Scleroderma'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C1619966', 'cui_str': 'abatacept'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}]",,0.0570303,Abatacept (which blocks T lymphocyte activation) has demonstrated utility for skin and joint disease in systemic sclerosis; a recent clinical trial failed to demonstrate benefits in improving skin thickness compared to placebo.,"[{'ForeName': 'Durga Prasanna', 'Initials': 'DP', 'LastName': 'Misra', 'Affiliation': 'Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS), Lucknow, 226014, India. durgapmisra@gmail.com.'}, {'ForeName': 'Sakir', 'Initials': 'S', 'LastName': 'Ahmed', 'Affiliation': 'Department of Clinical Immunology and Rheumatology, Kalinga Institute of Medical Sciences, Bhubaneswar, India.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Agarwal', 'Affiliation': 'Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS), Lucknow, 226014, India.'}]",Rheumatology international,['10.1007/s00296-020-04515-6']
496,32267783,"The Effects of Apnea Training, Using Voluntary Breath Holds, on High Altitude Acclimation: Breathe-High Altitude Study.","Introduction:  There is evidence that intermittent hypoxic exposure (IHE) may improve high altitude (HA) performance. In this study, the effects of short-term IHE through voluntary apnea training on HA-related symptoms, including acute mountain sickness (AMS), were examined for the first time.  Methods:  Forty healthy adults were randomized to a self-administered apnea training ( n  = 19) or control ( n  = 21 no apnea training) group before ascent to an altitude of 5100 m in the Himalayas over 14 days. The apnea training was conducted at sea level (SL) and consisted of five breath holds per day in week 1, seven in week 2, followed by 10 per day from weeks 3 to 6 and until HA exposure. Saturation of arterial oxygen (SpO 2 ), heart rate, sleep quality (Insomnia Severity Index [ISI]), rating of perceived exertion (RPE), blood pressure, and Lake Louise scores were measured at SL (in the United Kingdom) and at HA at 1400, 2700, 3400-3700, 4050-4200, 4800, and 5100-5200 m. Anxiety (Generalized Anxiety Disorder-7 [GAD-7]) scores were examined at SL, 1400, and 5100-5200 m.  Results:  Apnea training led to a significant increase in the mean longest breath-hold times from baseline (80.42 ± 32.49 [median 87.00] seconds) to the end of week 6 (107.02 ± 43.65 [113.00] seconds), respectively ( p  = 0.009). There was no significant difference in the prevalence of AMS (8/19 = 42.1% vs. 11/21 = 52.4%; RR 0.80; 95% confidence interval 0.41-1.57:  p  = 0.80) or in GAD-7, ISI and RPE, SpO 2,  heart rate, or blood pressure among the apnea versus control groups, respectively, at HA.  Conclusions:  Apnea training does not lessen HA-related symptoms in healthy adults traveling up to 5200 m. Larger studies using more challenging apnea protocols and at higher altitudes should be considered.",2020,"There was no significant difference in the prevalence of AMS (8/19 = 42.1% vs. 11/21 = 52.4%; RR 0.80; 95% confidence interval 0.41-1.57:  p  = 0.80) or in GAD-7, ISI and RPE, SpO 2,  heart rate, or blood pressure among the apnea versus control groups, respectively, at HA.  ","['healthy adults', 'Forty healthy adults']","['Apnea Training', 'self-administered apnea training ( n \u2009=\u200919) or control ( n \u2009=\u200921 no apnea training) group before ascent to an altitude of 5100\u2009m in the Himalayas', 'intermittent hypoxic exposure (IHE', 'Apnea training', 'short-term IHE through voluntary apnea training']","['high altitude (HA) performance', 'HA-related symptoms, including acute mountain sickness (AMS', 'prevalence of AMS', 'mean longest breath-hold times', 'm. Anxiety (Generalized Anxiety Disorder-7 [GAD-7', 'GAD-7, ISI and RPE, SpO 2,  heart rate, or blood pressure', 'Saturation of arterial oxygen (SpO 2 ), heart rate, sleep quality (Insomnia Severity Index [ISI]), rating of perceived exertion (RPE), blood pressure, and Lake Louise scores']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002349', 'cui_str': 'Altitude'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}]","[{'cui': 'C0238617', 'cui_str': 'High altitude'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0238284', 'cui_str': 'Acute mountain sickness'}, {'cui': 'C1860224', 'cui_str': 'Ablepharon macrostomia syndrome'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0235744', 'cui_str': 'Interrupted breathing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0337049', 'cui_str': 'Lake'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",40.0,0.0160093,"There was no significant difference in the prevalence of AMS (8/19 = 42.1% vs. 11/21 = 52.4%; RR 0.80; 95% confidence interval 0.41-1.57:  p  = 0.80) or in GAD-7, ISI and RPE, SpO 2,  heart rate, or blood pressure among the apnea versus control groups, respectively, at HA.  ","[{'ForeName': 'Nishma', 'Initials': 'N', 'LastName': 'Shah', 'Affiliation': 'Department of Surgical Sciences, Institute of Sports and Exercise Health, University College, London, United Kingdom.'}, {'ForeName': 'Kyo', 'Initials': 'K', 'LastName': 'Bye', 'Affiliation': 'Defence Medical Services, Lichfield, United Kingdom.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Marshall', 'Affiliation': 'Department of Surgical Sciences, Institute of Sports and Exercise Health, University College, London, United Kingdom.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Woods', 'Affiliation': 'Defence Medical Services, Lichfield, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': ""O'Hara"", 'Affiliation': 'Research Institute for Sport, Physical Activity and Leisure, Leeds Beckett University, Leeds, United Kingdom.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Barlow', 'Affiliation': 'Research Institute for Sport, Physical Activity and Leisure, Leeds Beckett University, Leeds, United Kingdom.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Rimmer', 'Affiliation': 'Defence Medical Services, Lichfield, United Kingdom.'}, {'ForeName': 'Christopher John', 'Initials': 'CJ', 'LastName': 'Boos', 'Affiliation': 'Research Institute for Sport, Physical Activity and Leisure, Leeds Beckett University, Leeds, United Kingdom.'}]",High altitude medicine & biology,['10.1089/ham.2019.0087']
497,32172441,Healthcare utilization and productivity loss in glioma patients and family caregivers: the impact of treatable psychological symptoms.,"BACKGROUND


Gliomas are associated with significant healthcare burden, yet reports of costs are scarce. While many costs are unavoidable there may be treatable symptoms contributing to higher costs. We describe healthcare and societal costs in glioma patients at high risk for depression and their family caregivers, and explore relationships between costs and treatable symptoms.
METHODS


Data from a multicenter randomized trial on effects of internet-based therapy for depressive symptoms were used (NTR3223). Costs of self-reported healthcare utilization, medication use, and productivity loss were calculated for patients and caregivers separately. We used generalized linear regression models to predict costs with depressive symptoms, fatigue, cognitive complaints, tumor grade (low-/high-grade), disease status (stable or active/progression), and intervention (use/non-use) as predictors.
RESULTS


Multiple assessments from baseline through 12 months from 91 glioma patients and 46 caregivers were used. Mean overall costs per year were M = €20,587.53 (sd = €30,910.53) for patients and M = €5,581.49 (sd = €13,102.82) for caregivers. In patients, higher healthcare utilization costs were associated with more depressive symptoms; higher medication costs were associated with active/progressive disease. In caregivers, higher overall costs were linked with increased caregiver fatigue, cognitive complaints, and lower patient tumor grade. Higher healthcare utilization costs were related to more cognitive complaints and lower tumor grade. More productivity loss costs were associated with increased fatigue (all P < 0.05).
CONCLUSIONS


There are substantial healthcare and societal costs for glioma patients and caregivers. Associations between costs and treatable psychological symptoms indicate that possibly, adequate support could decrease costs.
TRIAL REGISTRATION


Netherlands Trial Register NTR3223.",2020,"Mean overall costs per year were M = €20,587.53 (sd = €30,910.53) for patients and M = €5,581.49 (sd = €13,102.82) for caregivers.","['glioma patients and family caregivers', 'glioma patients at high risk for depression and their family caregivers', '91 glioma patients and 46 caregivers']",['internet-based therapy'],"['productivity loss costs', 'Higher healthcare utilization costs', 'Costs of self-reported healthcare utilization, medication use, and productivity loss', 'caregiver fatigue, cognitive complaints, and lower patient tumor grade', 'overall costs', 'fatigue', 'depressive symptoms, fatigue, cognitive complaints, tumor grade (low-/high-grade), disease status (stable or active/progression', 'healthcare utilization costs', 'Mean overall costs', 'Healthcare utilization and productivity loss']","[{'cui': 'C0017638', 'cui_str': 'Glial Cell Tumors'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3179006', 'cui_str': 'Tumor Grading'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",91.0,0.0985539,"Mean overall costs per year were M = €20,587.53 (sd = €30,910.53) for patients and M = €5,581.49 (sd = €13,102.82) for caregivers.","[{'ForeName': 'Florien W', 'Initials': 'FW', 'LastName': 'Boele', 'Affiliation': ""Leeds Institute of Medical Research at St James's, St James's University Hospital, Leeds, LS9 7TF, UK. F.Boele@leeds.ac.uk.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Meads', 'Affiliation': 'Faculty of Medicine and Health, Leeds Institute of Health Sciences, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Femke', 'Initials': 'F', 'LastName': 'Jansen', 'Affiliation': 'Department of Otolaryngology - Head & Neck Surgery, Amsterdam UMC, VU University Medical Center, PO Box 7057, 1007 MB, Amsterdam, The Netherlands.'}, {'ForeName': 'Irma M', 'Initials': 'IM', 'LastName': 'Verdonck-de Leeuw', 'Affiliation': 'Department of Otolaryngology - Head & Neck Surgery, Amsterdam UMC, VU University Medical Center, PO Box 7057, 1007 MB, Amsterdam, The Netherlands.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Heimans', 'Affiliation': 'Department of Neurology, Amsterdam UMC, VU University Medical Center, PO Box 7057, 1007 MB, Amsterdam, The Netherlands.'}, {'ForeName': 'Jaap C', 'Initials': 'JC', 'LastName': 'Reijneveld', 'Affiliation': 'Department of Neurology, Amsterdam UMC, VU University Medical Center, PO Box 7057, 1007 MB, Amsterdam, The Netherlands.'}, {'ForeName': 'Susan C', 'Initials': 'SC', 'LastName': 'Short', 'Affiliation': ""Leeds Institute of Medical Research at St James's, St James's University Hospital, Leeds, LS9 7TF, UK.""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Klein', 'Affiliation': 'Department of Medical Psychology, Amsterdam UMC, VU University Medical Center, PO Box 7057, 1007 MB, Amsterdam, The Netherlands.'}]",Journal of neuro-oncology,['10.1007/s11060-020-03454-3']
498,32277639,"Comparison of clinical efficacy between laparotomy and laparoscopic radical surgery for gastric cancer and their effects on CRP, CEA and insulin resistance.","PURPOSE


This study aimed to compare between the clinical efficacy of laparotomy and laparoscopic radical resection of gastric cancer and their effects on C-reactive protein (CRP), carcinoembryonic antigen (CEA) and insulin resistance.
METHODS


210 patients with gastric cancer admitted to Dongying People's Hospital from September 2013 to July 2015 were included in this study. The patients were divided according to surgery type into the laparotomy group (n = 104) and the laparoscopy group (n = 106). The operative time, intraoperative bleeding, lymph node dissection, postoperative exhaust time and postoperative complications were recorded. Peripheral blood CRP and CEA levels were measured by enzyme-linked immunosorbent assay (ELISA). Fasting blood glucose (FBG), AND fasting insulin (FINS) levels were measured before operation and 1, 3 and 7 days after operation. All patients were followed up by telephone and letters for 5 years. The patients in the two groups were investigated by a quality of life questionnaire.
RESULTS


The intraoperative bleeding and postoperative exhaust time in THE laparoscopy group were significantly lower than those in the traditional laparotomy group, while the operative time and the number of lymph node dissections were higher. The CRP and CEA in the laparoscopy group were significantly lower than in the laparotomy group on the 1ST, 2ND and 3RD day after operation (p<0.05). The FBG, FINS and HOMA-IR in the laparoscopy group were significantly lower than those in the laparotomy group on the 1ST and 3RD day after operation (p<0.05). The scores of quality of life in the laparoscopy group were lower than those in the laparotomy group (p<0.05).
CONCLUSION


In conclusion, laparoscopic radical resection of gastric cancer can reduce the levels of CRP, CEA and insulin resistance, while the degree of inflammation and insulin resistance after laparoscopy is lower than that after laparotomy, which is beneficial to postoperative recovery.",2020,"The CRP and CEA in the laparoscopy group were significantly lower than in the laparotomy group on the 1ST, 2ND and 3RD day after operation (p<0.05).","[""210 patients with gastric cancer admitted to Dongying People's Hospital from September 2013 to July 2015 were included in this study""]","['laparotomy and laparoscopic radical resection', 'laparoscopy', 'THE laparoscopy', 'laparotomy and laparoscopic radical surgery', 'laparoscopic radical resection']","['CRP and CEA', 'Peripheral blood CRP and CEA levels', 'intraoperative bleeding and postoperative exhaust time', 'FBG, FINS and HOMA-IR', 'operative time and the number of lymph node dissections', 'CRP, CEA and insulin resistance', 'Fasting blood glucose (FBG), AND fasting insulin (FINS) levels', 'C-reactive protein (CRP), carcinoembryonic antigen (CEA) and insulin resistance', 'levels of CRP, CEA and insulin resistance', 'operative time, intraoperative bleeding, lymph node dissection, postoperative exhaust time and postoperative complications', 'quality of life questionnaire', 'scores of quality of life']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0007082', 'cui_str': 'Carcinoembryonic antigen'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",210.0,0.0144619,"The CRP and CEA in the laparoscopy group were significantly lower than in the laparotomy group on the 1ST, 2ND and 3RD day after operation (p<0.05).","[{'ForeName': 'Xudong', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""Department of Gastroenterological Surgery, Dongying People's Hospital, Dongying 257091, P.R. China.""}, {'ForeName': 'Xingguang', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Weichun', 'Initials': 'W', 'LastName': 'Cui', 'Affiliation': ''}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': ''}]",Journal of B.U.ON. : official journal of the Balkan Union of Oncology,[]
499,32272623,The Effect of Solution-Focused Group Counseling Intervention on College Students' Internet Addiction: A Pilot Study.,"This pilot study aimed to explore the effect of solution-focused group counseling intervention on Internet addiction among college students. Eighteen college students participated in this study, out of which nine subjects were assigned into the experimental group and the rest ( n  = 9) to a control group. The experimental group received group counseling for five weeks, while the control group did not receive any intervention. The revised version of the Chinese Internet Addiction Scale (CIAS-R) was used to capture pre-test and post-test excessive use in the two groups. The experimental group was also subjected to a follow-up test and self-reported Internet addiction scores six months after the end of group counseling. Results showed that after the five-week solution-focused group counseling, the scores of four dimensions of the CIAS-R in the experimental group had CIAS-R decreased, and the reduction trend of the total score of CIAS-R was similar across all subjects in this group. The treatment effect was larger than the placebo reduction in the control group in two dimensions: compulsive and withdrawal (Sym-C & Sym-W) and tolerance (Sym-T) symptoms. Qualitative research confirmed the conclusions from the quantitative data, showing that the experimental group reduced its Internet addiction symptoms. Overall, the findings suggested that solution-focused group counseling had positive intervention effects on Internet addiction.",2020,The treatment effect was larger than the placebo reduction in the control group in two dimensions: compulsive and withdrawal (Sym-C & Sym-W) and tolerance (Sym-T) symptoms.,"['Eighteen college students', ""College Students' Internet Addiction"", 'college students']","['solution-focused group counseling intervention', 'control group did not receive any intervention', 'Solution-Focused Group Counseling Intervention']","['Internet addiction', 'CIAS-R', 'Internet addiction symptoms', 'Chinese Internet Addiction Scale (CIAS-R', 'total score of CIAS-R']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}]","[{'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0170509', 'cui_str': 'CyADIC protocol'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",18.0,0.0245584,The treatment effect was larger than the placebo reduction in the control group in two dimensions: compulsive and withdrawal (Sym-C & Sym-W) and tolerance (Sym-T) symptoms.,"[{'ForeName': 'Xinhe', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Faculty of Psychology, Ministry of Education Key Laboratory of Cognition and Personality, Southwest University, Chongqing 400715, China.'}, {'ForeName': 'Xiaoxuan', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': 'Faculty of Psychology, Ministry of Education Key Laboratory of Cognition and Personality, Southwest University, Chongqing 400715, China.'}, {'ForeName': 'Shuowei', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Faculty of Psychology, Ministry of Education Key Laboratory of Cognition and Personality, Southwest University, Chongqing 400715, China.'}, {'ForeName': 'Jingwen', 'Initials': 'J', 'LastName': 'Qiu', 'Affiliation': 'Faculty of Psychology, Ministry of Education Key Laboratory of Cognition and Personality, Southwest University, Chongqing 400715, China.'}, {'ForeName': 'Ofir', 'Initials': 'O', 'LastName': 'Turel', 'Affiliation': 'Information Systems and Decision Sciences, California State University, Fullerton, CA 92831, USA.'}, {'ForeName': 'Qinghua', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': 'Faculty of Psychology, Ministry of Education Key Laboratory of Cognition and Personality, Southwest University, Chongqing 400715, China.'}]",International journal of environmental research and public health,['10.3390/ijerph17072519']
500,32159257,"A randomized, double-blind, placebo-controlled clinical trial, evaluating the garlic supplement effects on some serum biomarkers of oxidative stress, and quality of life in women with rheumatoid arthritis.","AIM


Rheumatoid arthritis (RA), is a prevalent immune-inflammatory disease, which is associated with disabling pain. Oxidative stress might play a role in RA pathogenesis and outcomes. According to the antioxidant properties of garlic, the current study was performed to evaluate the garlic supplement effects on some serum levels of oxidative stress biomarkers, and quality of life in patients with rheumatoid arthritis.
METHODS


Seventy women with RA participated in this randomized, double-blind, placebo-controlled, parallel-design trial. The patients were randomly divided into two groups, receiving two tablets of either 500 mg garlic or placebo daily for 8 weeks. Serum levels of total antioxidant capacity (TAC) and malondialdehyde (MDA) and quality of life were determined at baseline and end of week 8. A health assessment questionnaire (HAQ) was used to evaluate the quality of life related to health.
RESULTS


Of 70 patients enrolled in the trial, 62 subjects were included in the final analysis. At the end of the study, there was a significant increase in serum levels of TAC in the garlic group as compared with the placebo group (26.58 ± 77.30 nmol of Trolox equivalent/ml vs 16.11 ± 0.92 nmol of Trolox equivalent/mL; P = .026). In addition, MDA levels were significantly decreased in the intervention group compared with the control group (-0.82 ± 1.99 nmol/mL vs 0.36 ± 2.57 nmol/mL; P = .032). Pain after activity and HAQ scores decreased in the garlic group compared with the placebo (-11.96 ± 13.43 mm vs -0.06 ± 13.41 mm; P < .001, 0.17 ± 20 vs 0.05 ± 0.15; P < .001, respectively).
CONCLUSIONS


The findings suggest that garlic supplementation for 8 weeks resulted in significant improvements in oxidative stress, HAQ in women with RA.",2020,"Pain after activity and HAQ scores decreased in the garlic group compared to the placebo (-11.96±13.43 mm vs. -0.06±13.41 mm; P<0.001, 0.17±20 vs. 0.05±0.15; P<0.001, respectively).
","['62 subjects were included in the final analysis', '70 patients enrolled in the trial', 'women with rheumatoid arthritis', 'Seventy women with RA', 'women with RA', 'patients with rheumatoid arthritis']","['garlic supplementation', '500 mg garlic or placebo', 'placebo']","['quality of life related to health', 'oxidative stress biomarkers, and quality of life', 'Pain after activity and HAQ scores', 'MDA levels', 'oxidative stress, HAQ', 'serum biomarkers of oxidative stress, and quality of life', 'Serum levels of total antioxidant capacity (TAC) and malondialdehyde (MDA) and quality of life', 'serum levels of TAC']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0885057', 'cui_str': 'Garlic preparation'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0034380'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0102923', 'cui_str': 'HAQ'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}]",62.0,0.588452,"Pain after activity and HAQ scores decreased in the garlic group compared to the placebo (-11.96±13.43 mm vs. -0.06±13.41 mm; P<0.001, 0.17±20 vs. 0.05±0.15; P<0.001, respectively).
","[{'ForeName': 'Seyedeh Parisa', 'Initials': 'SP', 'LastName': 'Moosavian', 'Affiliation': 'Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Zamzam', 'Initials': 'Z', 'LastName': 'Paknahad', 'Affiliation': 'Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Habibagahi', 'Affiliation': 'Department of Rheumatology, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",International journal of clinical practice,['10.1111/ijcp.13498']
501,31854465,Little Change in Functional Brain Networks Following Acute Levodopa in Drug-Naïve Parkinson's Disease.,"OBJECTIVE


The objective of this study was to investigate the effects of levodopa on functional brain networks in Parkinson's disease.
METHODS


We acquired resting state functional magnetic resonance imaging in 30 drug-naïve participants with Parkinson's disease and 20 age-matched healthy controls. Each participant was studied following administration of a single oral dose of either levodopa or placebo in a randomized, double-blind, crossover design.
RESULTS


The greatest observed differences in functional connectivity were between Parkinson's disease versus control participants, independent of pharmacologic intervention. By contrast, the effects of levodopa were much smaller and detectable only in the Parkinson's disease group. Moreover, although levodopa administration in the Parkinson's disease group measurably improved motor performance, it did not increase the similarity of functional connectivity in Parkinson's disease to the control group.
CONCLUSIONS


We found that a single, small dose of levodopa did not normalize functional connectivity in drug-naïve Parkinson's disease. © 2019 International Parkinson and Movement Disorder Society.",2020,"The greatest observed differences in functional connectivity were between Parkinson's disease versus control participants, independent of pharmacologic intervention.","[""30 drug-naïve participants with Parkinson's disease and 20 age-matched healthy controls"", ""Parkinson's disease""]","['levodopa or placebo', 'levodopa', 'Acute Levodopa']","['motor performance', 'functional connectivity', 'functional brain networks', 'similarity of functional connectivity', 'Functional Brain Networks']","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}]",,0.217946,"The greatest observed differences in functional connectivity were between Parkinson's disease versus control participants, independent of pharmacologic intervention.","[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'White', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Meghan C', 'Initials': 'MC', 'LastName': 'Campbell', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Dake', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'BioRankings, St. Louis, Missouri, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Shannon', 'Affiliation': 'BioRankings, St. Louis, Missouri, USA.'}, {'ForeName': 'Abraham Z', 'Initials': 'AZ', 'LastName': 'Snyder', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Joel S', 'Initials': 'JS', 'LastName': 'Perlmutter', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, St. Louis, Missouri, USA.'}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.27942']
502,31227777,The effect of cognitive training on the brain's local connectivity organization in healthy older adults.,"Cognitive training has been shown effective in improving the cognitive function of older adults. While training related plasticity of the brain has been observed at different levels, it is still open to exploration whether local functional connectivity (FC) may be affected by training. Here, we examined the neuroimaging data from a previous randomized-controlled double-blinded behavioural study, in which healthy older adults participated in a 3-month cognitive training program. Resting-state fMRI was acquired at baseline and one year after training. The local FC in the brain was estimated using the regional homogeneity (ReHo), and the high ReHo clusters (HRCs) were extracted to quantify the level of local FC integration. Results showed that: (i) HRCs exhibited a power-law size distribution; (ii) local FC were less integrated in older participants than in younger participants; (iii) local FC in older participants of the training group became more integrated after training than the control group; (iv) the baseline local FC integration was positively correlated with educational level. These results indicated a training-related alteration in local FC.",2019,Results showed that: (i) HRCs exhibited a power-law size distribution; (ii) local FC were less integrated in older participants than in younger participants; (iii) local FC in older participants of the training group became more integrated after training than the control group; (iv) the baseline local FC integration was positively correlated with educational level.,"['healthy older adults participated in a 3-month', 'healthy older adults', 'older adults']","['cognitive training', 'cognitive training program', 'Cognitive training']","['local FC', 'Resting-state fMRI', 'baseline local FC integration', ' (i) HRCs exhibited a power-law size distribution; (ii) local FC']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C0220866', 'cui_str': 'laws'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}]",,0.0245604,Results showed that: (i) HRCs exhibited a power-law size distribution; (ii) local FC were less integrated in older participants than in younger participants; (iii) local FC in older participants of the training group became more integrated after training than the control group; (iv) the baseline local FC integration was positively correlated with educational level.,"[{'ForeName': 'Lifu', 'Initials': 'L', 'LastName': 'Deng', 'Affiliation': 'School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Centre, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xinyi', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Centre, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Feng', 'Affiliation': 'Department of Psychiatry, Tongji Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Centre, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Wenyuan', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry, Tongji Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Shanbao', 'Initials': 'S', 'LastName': 'Tong', 'Affiliation': 'School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Junfeng', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, China. jfsun@sjtu.edu.cn.'}, {'ForeName': 'Chunbo', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Centre, Shanghai Jiao Tong University School of Medicine, Shanghai, China. icb@smhc.org.cn.'}]",Scientific reports,['10.1038/s41598-019-45463-x']
503,32277650,"Comparison of clinical efficacy between laparotomy and laparoscopic radical surgery for gastric cancer and their effects on CRP, CEA and insulin resistance.","PURPOSE


This study aimed to compare between the clinical efficacy of laparotomy and laparoscopic radical resection of gastric cancer and their effects on C-reactive protein (CRP), carcinoembryonic antigen (CEA) and insulin resistance.
METHODS


210 patients with gastric cancer admitted to Dongying People's Hospital from September 2013 to July 2015 were included in this study. The patients were divided according to surgery type into the laparotomy group (n = 104) and the laparoscopy group (n = 106). The operative time, intraoperative bleeding, lymph node dissection, postoperative exhaust time and postoperative complications were recorded. Peripheral blood CRP and CEA levels were measured by enzyme-linked immunosorbent assay (ELISA). Fasting blood glucose (FBG), AND fasting insulin (FINS) levels were measured before operation and 1, 3 and 7 days after operation. All patients were followed up by telephone and letters for 5 years. The patients in the two groups were investigated by a quality of life questionnaire.
RESULTS


The intraoperative bleeding and postoperative exhaust time in THE laparoscopy group were significantly lower than those in the traditional laparotomy group, while the operative time and the number of lymph node dissections were higher. The CRP and CEA in the laparoscopy group were significantly lower than in the laparotomy group on the 1ST, 2ND and 3RD day after operation (p<0.05). The FBG, FINS and HOMA-IR in the laparoscopy group were significantly lower than those in the laparotomy group on the 1ST and 3RD day after operation (p<0.05). The scores of quality of life in the laparoscopy group were lower than those in the laparotomy group (p<0.05).
CONCLUSION


In conclusion, laparoscopic radical resection of gastric cancer can reduce the levels of CRP, CEA and insulin resistance, while the degree of inflammation and insulin resistance after laparoscopy is lower than that after laparotomy, which is beneficial to postoperative recovery.",2020,"The CRP and CEA in the laparoscopy group were significantly lower than in the laparotomy group on the 1ST, 2ND and 3RD day after operation (p<0.05).","[""210 patients with gastric cancer admitted to Dongying People's Hospital from September 2013 to July 2015 were included in this study""]","['laparotomy and laparoscopic radical resection', 'laparoscopy', 'THE laparoscopy', 'laparotomy and laparoscopic radical surgery', 'laparoscopic radical resection']","['CRP and CEA', 'Peripheral blood CRP and CEA levels', 'intraoperative bleeding and postoperative exhaust time', 'FBG, FINS and HOMA-IR', 'operative time and the number of lymph node dissections', 'CRP, CEA and insulin resistance', 'Fasting blood glucose (FBG), AND fasting insulin (FINS) levels', 'C-reactive protein (CRP), carcinoembryonic antigen (CEA) and insulin resistance', 'levels of CRP, CEA and insulin resistance', 'operative time, intraoperative bleeding, lymph node dissection, postoperative exhaust time and postoperative complications', 'quality of life questionnaire', 'scores of quality of life']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0007082', 'cui_str': 'Carcinoembryonic antigen'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",210.0,0.0144619,"The CRP and CEA in the laparoscopy group were significantly lower than in the laparotomy group on the 1ST, 2ND and 3RD day after operation (p<0.05).","[{'ForeName': 'Xudong', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""Department of Gastroenterological Surgery, Dongying People's Hospital, Dongying 257091, P.R. China.""}, {'ForeName': 'Xingguang', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Weichun', 'Initials': 'W', 'LastName': 'Cui', 'Affiliation': ''}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': ''}]",Journal of B.U.ON. : official journal of the Balkan Union of Oncology,[]
504,32277749,"Gospel Music: A Catalyst for Retention, Engagement, and Positive Health Outcomes for African Americans in a Cardiovascular Prevention and Treatment Program.","Context


Mortality associated with cardiovascular disease is significantly higher in African Americans compared with people of other ethnicities, with hypertension being the single most significant risk factor in this population. Underdiagnosis and undertreatment of hypertension is common. Although cardiovascular lifestyle education and self-management programs are available for the general public, many African Americans prefer to learn about health-promoting activities through interactive programs led by church ministries.
Objective


This study examined the influence of adding a faith-based protocol using creative musical expression as a catalyst for improving retention, engagement, and positive health outcomes for African Americans participating in a 1-y, lifestyle skills program for reducing cardiovascular risk factors.
Design


The study was a randomized, controlled trial.
Setting


The study occurred at Rodman Street Missionary Baptist Church (Pittsburgh, PA, USA).
Participants


Participants were African Americans with at least 2 of the following medical conditions: high blood pressure, elevated cholesterol and/or triglycerides, heart attack, angina, stroke, irregular heartbeats, palpitations, shortness of breath, dizziness or fainting, diabetes, and tobacco use.
Intervention


Intervention and control groups both participated every other week in one 45-min structured cardiovascular risk reduction educational session over the course of 1 year. During alternative weeks, sessions comprised blood pressure checks, coupled with individualized support discussions focused on challenges and identified obstacles to adherence. In addition to the aforementioned sessions, the intervention group participated in a novel gospel music program with weekly, 45-minute vocal and instrumental sessions.
Outcome Measures


Outcome measures include retention, attendance, systolic and diastolic blood pressures, weight, body mass index, hip measurement, and waist measurement as well as the Short Form-12 (SH-12) Health Survey.
Results


Subjects in the intervention group demonstrated a statistically significant 83.3% retention rate in the course of 1 year compared with only 54.3% for the control group (cardiovascular lifestyle education sessions alone). Six dropouts were noted in the intervention group in sharp contrast to 16 dropouts in the control group. Participants in the intervention group were 4.21 times more likely to complete the program than the control group. A significant difference was also noted for attendance, which was higher for the intervention group (21.33 sessions for the intervention group vs 17.95 sessions for the control group). Statistically significant systolic blood pressure reductions noted in both groups were sustained 6 mo postprogram conclusion. In addition, a statistically significant pre-between post-between group improvement in SF-12 Physical Component Scores was noted for intervention subjects in sharp contrast with controls who actually demonstrated worsening scores.
Conclusions


The addition of a gospel music program as a catalyst for increase engagement in a sustainable, healthy lifestyle program warrants further consideration and additional study in African American churches.",2020,"A significant difference was also noted for attendance, which was higher for the intervention group (21.33 sessions for the intervention group vs 17.95 sessions for the control group).","['African American churches', 'African Americans', 'African Americans participating in a 1-y', 'Participants\n\n\nParticipants were African Americans with at least 2 of the following medical conditions: high blood pressure, elevated cholesterol and/or triglycerides, heart attack, angina, stroke, irregular heartbeats, palpitations, shortness of breath, dizziness or fainting, diabetes, and tobacco use']","['faith-based protocol using creative musical expression', 'lifestyle skills program', 'Intervention\n\n\nIntervention and control groups both participated every other week in one 45-min structured cardiovascular risk reduction educational session', 'Gospel Music', 'novel gospel music program with weekly, 45-minute vocal and instrumental sessions']","['retention, engagement, and positive health outcomes', 'SF-12 Physical Component Scores', 'retention rate', 'systolic blood pressure reductions', 'retention, attendance, systolic and diastolic blood pressures, weight, body mass index, hip measurement, and waist measurement as well as the Short Form-12 (SH-12) Health Survey']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0562324', 'cui_str': 'Church'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0030252', 'cui_str': 'Palpitations'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0040335', 'cui_str': 'Tobacco use'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1442463', 'cui_str': 'Forty-five minutes'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",6.0,0.0431136,"A significant difference was also noted for attendance, which was higher for the intervention group (21.33 sessions for the intervention group vs 17.95 sessions for the control group).","[{'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Bittman', 'Affiliation': ''}, {'ForeName': 'Indu', 'Initials': 'I', 'LastName': 'Poornima', 'Affiliation': ''}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'R Eric', 'Initials': 'RE', 'LastName': 'Heidel', 'Affiliation': ''}]",Advances in mind-body medicine,[]
505,31981294,Electrophysiological correlates of action observation treatment in children with cerebral palsy: A pilot study.,"Action Observation Treatment (AOT) has been shown to be effective in the functional recovery of several clinical populations. However, little is known about the neural underpinnings of the clinical efficacy of AOT in children with Cerebral Palsy (CP). Using electroencephalography (EEG), we recorded µ rhythm desynchronization as an index of sensorimotor cortex modulation during a passive action observation task before and after AOT. The relationship between sensorimotor modulation and clinical outcomes was also assessed. Eight children with CP entered the present randomized controlled crossover pilot study in which the experimental AOT preceded or followed a control Videogame Observation Treatment (VOT). Results provide further evidence of the clinical efficacy of AOT for improving hand motor function in CP, as assessed with the Assisting Hand Assessment (AHA) and Melbourne Assessment of Unilateral Upper Limb Function Scale (MUUL). The novel finding is that AOT increases µ rhythm desynchronization at scalp locations corresponding to the hand representation areas. This effect is associated to functional improvement assessed with the MUUL. These preliminary findings, although referred to as a small sample, suggest that AOT may affect upper limb motor recovery in children with CP and modulate the activation of sensorimotor areas, offering a potential neurophysiological correlate to support the clinical utility of AOT.",2019,"Results provide further evidence of the clinical efficacy of AOT for improving hand motor function in CP, as assessed with the Assisting Hand Assessment (AHA) and Melbourne Assessment of Unilateral Upper Limb Function Scale (MUUL).","['children with CP', 'Eight children with CP', 'children with Cerebral Palsy (CP', 'children with Cerebral Palsy']","['AOT', 'Action Observation Treatment (AOT', 'control Videogame Observation Treatment (VOT', 'electroencephalography (EEG']",['Assisting Hand Assessment (AHA) and Melbourne Assessment of Unilateral Upper Limb Function Scale (MUUL'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}]","[{'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}]","[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2732438', 'cui_str': 'Melbourne assessment of unilateral upper limb function'}, {'cui': 'C0222045'}]",8.0,0.0195631,"Results provide further evidence of the clinical efficacy of AOT for improving hand motor function in CP, as assessed with the Assisting Hand Assessment (AHA) and Melbourne Assessment of Unilateral Upper Limb Function Scale (MUUL).","[{'ForeName': 'Ermanno', 'Initials': 'E', 'LastName': 'Quadrelli', 'Affiliation': 'Department of Psychology, Milan Center for Neuroscience, University of Milano-Bicocca, Milano, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Anzani', 'Affiliation': 'Child Neuropsychiatry Unit, ASST dei Sette Laghi, Varese, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Ferri', 'Affiliation': 'Child Neuropsychiatry Unit, ASST dei Sette Laghi, Varese, Italy.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Bolognini', 'Affiliation': 'Department of Psychology, Milan Center for Neuroscience, University of Milano-Bicocca, Milano, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Maravita', 'Affiliation': 'Department of Psychology, Milan Center for Neuroscience, University of Milano-Bicocca, Milano, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Zambonin', 'Affiliation': 'Child Neuropsychiatry Unit, ASST dei Sette Laghi, Varese, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Turati', 'Affiliation': 'Department of Psychology, Milan Center for Neuroscience, University of Milano-Bicocca, Milano, Italy.'}]",Developmental neurobiology,['10.1002/dneu.22734']
506,30938127,Randomized controlled trial of a gluten-free diet in patients with schizophrenia positive for antigliadin antibodies (AGA IgG): a pilot feasibility study,"Background


Approximately one-third of people with schizophrenia have elevated levels of anti-gliadin antibodies of the immunoglobulin G type (AGA IgG) — a higher rate than seen in healthy controls. We performed the first double-blind clinical trial of gluten-free versus gluten-containing diets in a subset of patients with schizophrenia who were positive for AGA IgG.
Methods


In this pilot feasibility study, 16 participants with schizophrenia or schizoaffective disorder who had elevated AGA IgG (≥ 20 U) but were negative for celiac disease were admitted to an inpatient unit for a 5-week trial. All participants received standardized gluten-free meals and were randomized in a double-blind fashion to receive a shake containing 10 g of gluten flour or 10 g of rice flour each day. Participants were rated for psychiatric, cognitive and gastrointestinal symptoms at baseline and endpoint.
Results


Of the 16 participants, 14 completed the 5-week trial (2 discontinued early for administrative reasons). Compared with participants on the gluten-containing diet, participants on the gluten-free diet showed improvement on the Clinical Global Impressions scale (Cohen d = –0.75) and in negative symptoms (Cohen d = –0.53). We noted no improvement in positive or global cognitive symptoms, but did observe an improvement in attention favouring the gluten-free diet (Cohen d = 0.60). Robust improvements in gastrointestinal adverse effects occurred in the gluten-free group relative to the glutencontaining group. Adverse effects were similar between groups.
Limitations


This study was limited by its small sample size; larger studies are needed.
Conclusion


This feasibility study suggests that removal of gluten from the diet is associated with improvement in psychiatric and gastrointestinal symptoms in people with schizophrenia or schizoaffective disorder.",2019,Robust improvements in gastrointestinal adverse effects occurred in the gluten-free group relative to the glutencontaining group.,"['patients with schizophrenia who were positive for AGA IgG', '16 participants', 'people with schizophrenia or schizoaffective disorder', 'patients with schizophrenia positive for antigliadin antibodies (AGA IgG', '16 participants with schizophrenia or schizoaffective disorder who had elevated AGA IgG (≥ 20 U) but were negative for celiac disease were admitted to an inpatient unit for a 5-week trial']","['standardized gluten-free meals', 'shake containing 10 g of gluten flour or 10 g of rice flour each day', 'gluten-free versus gluten-containing diets', 'gluten-free diet']","['Clinical Global Impressions scale', 'negative symptoms', 'psychiatric, cognitive and gastrointestinal symptoms', 'positive or global cognitive symptoms', 'gastrointestinal adverse effects', 'Adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective Disorder'}, {'cui': 'C4552268', 'cui_str': 'Antigliadin antibody'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0007570', 'cui_str': 'Sprue, Nontropical'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C2362561', 'cui_str': 'Gluten'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0344351', 'cui_str': 'Gluten-Free Diet'}]","[{'cui': 'C3639708', 'cui_str': 'Clinical global impression scale'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0525041', 'cui_str': 'Cognitive Symptoms'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",16.0,0.413723,Robust improvements in gastrointestinal adverse effects occurred in the gluten-free group relative to the glutencontaining group.,"[{'ForeName': 'Deanna L.', 'Initials': 'DL', 'LastName': 'Kelly', 'Affiliation': 'From the Maryland Psychiatric Research Center (MPRC), School of Medicine, University of Maryland, College Park, MD (Kelly, McMahon, August, Feldman, Liu, Powell, Wehring, Buchanan, Gold, Carpenter); the Department of Orthopedics, School of Medicine, University of Maryland, College Park, MD (Demyanovich); the Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD (Rodriguez, Eaton); the Department of Pathology, Division of Immunology, Immune Disorders Laboratory, Johns Hopkins University, Baltimore, MD (Cˇiháková, Talor); the Spring Grove Hospital Center, Baltimore, MD (Richardson, Vyas, Adams); the Center for Celiac Research and Treatment, Massachusetts General Hospital, Boston, MA (Fasano); the Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD (Cascella); the Department of Psychology, Kent State University, Kent, OH (Sayer).'}, {'ForeName': 'Haley K.', 'Initials': 'HK', 'LastName': 'Demyanovich', 'Affiliation': 'From the Maryland Psychiatric Research Center (MPRC), School of Medicine, University of Maryland, College Park, MD (Kelly, McMahon, August, Feldman, Liu, Powell, Wehring, Buchanan, Gold, Carpenter); the Department of Orthopedics, School of Medicine, University of Maryland, College Park, MD (Demyanovich); the Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD (Rodriguez, Eaton); the Department of Pathology, Division of Immunology, Immune Disorders Laboratory, Johns Hopkins University, Baltimore, MD (Cˇiháková, Talor); the Spring Grove Hospital Center, Baltimore, MD (Richardson, Vyas, Adams); the Center for Celiac Research and Treatment, Massachusetts General Hospital, Boston, MA (Fasano); the Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD (Cascella); the Department of Psychology, Kent State University, Kent, OH (Sayer).'}, {'ForeName': 'Katrina M.', 'Initials': 'KM', 'LastName': 'Rodriguez', 'Affiliation': 'From the Maryland Psychiatric Research Center (MPRC), School of Medicine, University of Maryland, College Park, MD (Kelly, McMahon, August, Feldman, Liu, Powell, Wehring, Buchanan, Gold, Carpenter); the Department of Orthopedics, School of Medicine, University of Maryland, College Park, MD (Demyanovich); the Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD (Rodriguez, Eaton); the Department of Pathology, Division of Immunology, Immune Disorders Laboratory, Johns Hopkins University, Baltimore, MD (Cˇiháková, Talor); the Spring Grove Hospital Center, Baltimore, MD (Richardson, Vyas, Adams); the Center for Celiac Research and Treatment, Massachusetts General Hospital, Boston, MA (Fasano); the Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD (Cascella); the Department of Psychology, Kent State University, Kent, OH (Sayer).'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Ciháková', 'Affiliation': 'From the Maryland Psychiatric Research Center (MPRC), School of Medicine, University of Maryland, College Park, MD (Kelly, McMahon, August, Feldman, Liu, Powell, Wehring, Buchanan, Gold, Carpenter); the Department of Orthopedics, School of Medicine, University of Maryland, College Park, MD (Demyanovich); the Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD (Rodriguez, Eaton); the Department of Pathology, Division of Immunology, Immune Disorders Laboratory, Johns Hopkins University, Baltimore, MD (Cˇiháková, Talor); the Spring Grove Hospital Center, Baltimore, MD (Richardson, Vyas, Adams); the Center for Celiac Research and Treatment, Massachusetts General Hospital, Boston, MA (Fasano); the Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD (Cascella); the Department of Psychology, Kent State University, Kent, OH (Sayer).'}, {'ForeName': 'Monica V.', 'Initials': 'MV', 'LastName': 'Talor', 'Affiliation': 'From the Maryland Psychiatric Research Center (MPRC), School of Medicine, University of Maryland, College Park, MD (Kelly, McMahon, August, Feldman, Liu, Powell, Wehring, Buchanan, Gold, Carpenter); the Department of Orthopedics, School of Medicine, University of Maryland, College Park, MD (Demyanovich); the Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD (Rodriguez, Eaton); the Department of Pathology, Division of Immunology, Immune Disorders Laboratory, Johns Hopkins University, Baltimore, MD (Cˇiháková, Talor); the Spring Grove Hospital Center, Baltimore, MD (Richardson, Vyas, Adams); the Center for Celiac Research and Treatment, Massachusetts General Hospital, Boston, MA (Fasano); the Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD (Cascella); the Department of Psychology, Kent State University, Kent, OH (Sayer).'}, {'ForeName': 'Robert P.', 'Initials': 'RP', 'LastName': 'McMahon', 'Affiliation': 'From the Maryland Psychiatric Research Center (MPRC), School of Medicine, University of Maryland, College Park, MD (Kelly, McMahon, August, Feldman, Liu, Powell, Wehring, Buchanan, Gold, Carpenter); the Department of Orthopedics, School of Medicine, University of Maryland, College Park, MD (Demyanovich); the Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD (Rodriguez, Eaton); the Department of Pathology, Division of Immunology, Immune Disorders Laboratory, Johns Hopkins University, Baltimore, MD (Cˇiháková, Talor); the Spring Grove Hospital Center, Baltimore, MD (Richardson, Vyas, Adams); the Center for Celiac Research and Treatment, Massachusetts General Hospital, Boston, MA (Fasano); the Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD (Cascella); the Department of Psychology, Kent State University, Kent, OH (Sayer).'}, {'ForeName': 'Charles M.', 'Initials': 'CM', 'LastName': 'Richardson', 'Affiliation': 'From the Maryland Psychiatric Research Center (MPRC), School of Medicine, University of Maryland, College Park, MD (Kelly, McMahon, August, Feldman, Liu, Powell, Wehring, Buchanan, Gold, Carpenter); the Department of Orthopedics, School of Medicine, University of Maryland, College Park, MD (Demyanovich); the Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD (Rodriguez, Eaton); the Department of Pathology, Division of Immunology, Immune Disorders Laboratory, Johns Hopkins University, Baltimore, MD (Cˇiháková, Talor); the Spring Grove Hospital Center, Baltimore, MD (Richardson, Vyas, Adams); the Center for Celiac Research and Treatment, Massachusetts General Hospital, Boston, MA (Fasano); the Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD (Cascella); the Department of Psychology, Kent State University, Kent, OH (Sayer).'}, {'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Vyas', 'Affiliation': 'From the Maryland Psychiatric Research Center (MPRC), School of Medicine, University of Maryland, College Park, MD (Kelly, McMahon, August, Feldman, Liu, Powell, Wehring, Buchanan, Gold, Carpenter); the Department of Orthopedics, School of Medicine, University of Maryland, College Park, MD (Demyanovich); the Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD (Rodriguez, Eaton); the Department of Pathology, Division of Immunology, Immune Disorders Laboratory, Johns Hopkins University, Baltimore, MD (Cˇiháková, Talor); the Spring Grove Hospital Center, Baltimore, MD (Richardson, Vyas, Adams); the Center for Celiac Research and Treatment, Massachusetts General Hospital, Boston, MA (Fasano); the Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD (Cascella); the Department of Psychology, Kent State University, Kent, OH (Sayer).'}, {'ForeName': 'Heather A.', 'Initials': 'HA', 'LastName': 'Adams', 'Affiliation': 'From the Maryland Psychiatric Research Center (MPRC), School of Medicine, University of Maryland, College Park, MD (Kelly, McMahon, August, Feldman, Liu, Powell, Wehring, Buchanan, Gold, Carpenter); the Department of Orthopedics, School of Medicine, University of Maryland, College Park, MD (Demyanovich); the Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD (Rodriguez, Eaton); the Department of Pathology, Division of Immunology, Immune Disorders Laboratory, Johns Hopkins University, Baltimore, MD (Cˇiháková, Talor); the Spring Grove Hospital Center, Baltimore, MD (Richardson, Vyas, Adams); the Center for Celiac Research and Treatment, Massachusetts General Hospital, Boston, MA (Fasano); the Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD (Cascella); the Department of Psychology, Kent State University, Kent, OH (Sayer).'}, {'ForeName': 'Sharon M.', 'Initials': 'SM', 'LastName': 'August', 'Affiliation': 'From the Maryland Psychiatric Research Center (MPRC), School of Medicine, University of Maryland, College Park, MD (Kelly, McMahon, August, Feldman, Liu, Powell, Wehring, Buchanan, Gold, Carpenter); the Department of Orthopedics, School of Medicine, University of Maryland, College Park, MD (Demyanovich); the Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD (Rodriguez, Eaton); the Department of Pathology, Division of Immunology, Immune Disorders Laboratory, Johns Hopkins University, Baltimore, MD (Cˇiháková, Talor); the Spring Grove Hospital Center, Baltimore, MD (Richardson, Vyas, Adams); the Center for Celiac Research and Treatment, Massachusetts General Hospital, Boston, MA (Fasano); the Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD (Cascella); the Department of Psychology, Kent State University, Kent, OH (Sayer).'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Fasano', 'Affiliation': 'From the Maryland Psychiatric Research Center (MPRC), School of Medicine, University of Maryland, College Park, MD (Kelly, McMahon, August, Feldman, Liu, Powell, Wehring, Buchanan, Gold, Carpenter); the Department of Orthopedics, School of Medicine, University of Maryland, College Park, MD (Demyanovich); the Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD (Rodriguez, Eaton); the Department of Pathology, Division of Immunology, Immune Disorders Laboratory, Johns Hopkins University, Baltimore, MD (Cˇiháková, Talor); the Spring Grove Hospital Center, Baltimore, MD (Richardson, Vyas, Adams); the Center for Celiac Research and Treatment, Massachusetts General Hospital, Boston, MA (Fasano); the Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD (Cascella); the Department of Psychology, Kent State University, Kent, OH (Sayer).'}, {'ForeName': 'Nicola G.', 'Initials': 'NG', 'LastName': 'Cascella', 'Affiliation': 'From the Maryland Psychiatric Research Center (MPRC), School of Medicine, University of Maryland, College Park, MD (Kelly, McMahon, August, Feldman, Liu, Powell, Wehring, Buchanan, Gold, Carpenter); the Department of Orthopedics, School of Medicine, University of Maryland, College Park, MD (Demyanovich); the Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD (Rodriguez, Eaton); the Department of Pathology, Division of Immunology, Immune Disorders Laboratory, Johns Hopkins University, Baltimore, MD (Cˇiháková, Talor); the Spring Grove Hospital Center, Baltimore, MD (Richardson, Vyas, Adams); the Center for Celiac Research and Treatment, Massachusetts General Hospital, Boston, MA (Fasano); the Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD (Cascella); the Department of Psychology, Kent State University, Kent, OH (Sayer).'}, {'ForeName': 'Stephanie M.', 'Initials': 'SM', 'LastName': 'Feldman', 'Affiliation': 'From the Maryland Psychiatric Research Center (MPRC), School of Medicine, University of Maryland, College Park, MD (Kelly, McMahon, August, Feldman, Liu, Powell, Wehring, Buchanan, Gold, Carpenter); the Department of Orthopedics, School of Medicine, University of Maryland, College Park, MD (Demyanovich); the Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD (Rodriguez, Eaton); the Department of Pathology, Division of Immunology, Immune Disorders Laboratory, Johns Hopkins University, Baltimore, MD (Cˇiháková, Talor); the Spring Grove Hospital Center, Baltimore, MD (Richardson, Vyas, Adams); the Center for Celiac Research and Treatment, Massachusetts General Hospital, Boston, MA (Fasano); the Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD (Cascella); the Department of Psychology, Kent State University, Kent, OH (Sayer).'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'From the Maryland Psychiatric Research Center (MPRC), School of Medicine, University of Maryland, College Park, MD (Kelly, McMahon, August, Feldman, Liu, Powell, Wehring, Buchanan, Gold, Carpenter); the Department of Orthopedics, School of Medicine, University of Maryland, College Park, MD (Demyanovich); the Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD (Rodriguez, Eaton); the Department of Pathology, Division of Immunology, Immune Disorders Laboratory, Johns Hopkins University, Baltimore, MD (Cˇiháková, Talor); the Spring Grove Hospital Center, Baltimore, MD (Richardson, Vyas, Adams); the Center for Celiac Research and Treatment, Massachusetts General Hospital, Boston, MA (Fasano); the Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD (Cascella); the Department of Psychology, Kent State University, Kent, OH (Sayer).'}, {'ForeName': 'MacKenzie A.', 'Initials': 'MA', 'LastName': 'Sayer', 'Affiliation': 'From the Maryland Psychiatric Research Center (MPRC), School of Medicine, University of Maryland, College Park, MD (Kelly, McMahon, August, Feldman, Liu, Powell, Wehring, Buchanan, Gold, Carpenter); the Department of Orthopedics, School of Medicine, University of Maryland, College Park, MD (Demyanovich); the Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD (Rodriguez, Eaton); the Department of Pathology, Division of Immunology, Immune Disorders Laboratory, Johns Hopkins University, Baltimore, MD (Cˇiháková, Talor); the Spring Grove Hospital Center, Baltimore, MD (Richardson, Vyas, Adams); the Center for Celiac Research and Treatment, Massachusetts General Hospital, Boston, MA (Fasano); the Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD (Cascella); the Department of Psychology, Kent State University, Kent, OH (Sayer).'}, {'ForeName': 'Megan M.', 'Initials': 'MM', 'LastName': 'Powell', 'Affiliation': 'From the Maryland Psychiatric Research Center (MPRC), School of Medicine, University of Maryland, College Park, MD (Kelly, McMahon, August, Feldman, Liu, Powell, Wehring, Buchanan, Gold, Carpenter); the Department of Orthopedics, School of Medicine, University of Maryland, College Park, MD (Demyanovich); the Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD (Rodriguez, Eaton); the Department of Pathology, Division of Immunology, Immune Disorders Laboratory, Johns Hopkins University, Baltimore, MD (Cˇiháková, Talor); the Spring Grove Hospital Center, Baltimore, MD (Richardson, Vyas, Adams); the Center for Celiac Research and Treatment, Massachusetts General Hospital, Boston, MA (Fasano); the Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD (Cascella); the Department of Psychology, Kent State University, Kent, OH (Sayer).'}, {'ForeName': 'Heidi J.', 'Initials': 'HJ', 'LastName': 'Wehring', 'Affiliation': 'From the Maryland Psychiatric Research Center (MPRC), School of Medicine, University of Maryland, College Park, MD (Kelly, McMahon, August, Feldman, Liu, Powell, Wehring, Buchanan, Gold, Carpenter); the Department of Orthopedics, School of Medicine, University of Maryland, College Park, MD (Demyanovich); the Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD (Rodriguez, Eaton); the Department of Pathology, Division of Immunology, Immune Disorders Laboratory, Johns Hopkins University, Baltimore, MD (Cˇiháková, Talor); the Spring Grove Hospital Center, Baltimore, MD (Richardson, Vyas, Adams); the Center for Celiac Research and Treatment, Massachusetts General Hospital, Boston, MA (Fasano); the Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD (Cascella); the Department of Psychology, Kent State University, Kent, OH (Sayer).'}, {'ForeName': 'Robert W.', 'Initials': 'RW', 'LastName': 'Buchanan', 'Affiliation': 'From the Maryland Psychiatric Research Center (MPRC), School of Medicine, University of Maryland, College Park, MD (Kelly, McMahon, August, Feldman, Liu, Powell, Wehring, Buchanan, Gold, Carpenter); the Department of Orthopedics, School of Medicine, University of Maryland, College Park, MD (Demyanovich); the Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD (Rodriguez, Eaton); the Department of Pathology, Division of Immunology, Immune Disorders Laboratory, Johns Hopkins University, Baltimore, MD (Cˇiháková, Talor); the Spring Grove Hospital Center, Baltimore, MD (Richardson, Vyas, Adams); the Center for Celiac Research and Treatment, Massachusetts General Hospital, Boston, MA (Fasano); the Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD (Cascella); the Department of Psychology, Kent State University, Kent, OH (Sayer).'}, {'ForeName': 'James M.', 'Initials': 'JM', 'LastName': 'Gold', 'Affiliation': 'From the Maryland Psychiatric Research Center (MPRC), School of Medicine, University of Maryland, College Park, MD (Kelly, McMahon, August, Feldman, Liu, Powell, Wehring, Buchanan, Gold, Carpenter); the Department of Orthopedics, School of Medicine, University of Maryland, College Park, MD (Demyanovich); the Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD (Rodriguez, Eaton); the Department of Pathology, Division of Immunology, Immune Disorders Laboratory, Johns Hopkins University, Baltimore, MD (Cˇiháková, Talor); the Spring Grove Hospital Center, Baltimore, MD (Richardson, Vyas, Adams); the Center for Celiac Research and Treatment, Massachusetts General Hospital, Boston, MA (Fasano); the Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD (Cascella); the Department of Psychology, Kent State University, Kent, OH (Sayer).'}, {'ForeName': 'William T.', 'Initials': 'WT', 'LastName': 'Carpenter', 'Affiliation': 'From the Maryland Psychiatric Research Center (MPRC), School of Medicine, University of Maryland, College Park, MD (Kelly, McMahon, August, Feldman, Liu, Powell, Wehring, Buchanan, Gold, Carpenter); the Department of Orthopedics, School of Medicine, University of Maryland, College Park, MD (Demyanovich); the Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD (Rodriguez, Eaton); the Department of Pathology, Division of Immunology, Immune Disorders Laboratory, Johns Hopkins University, Baltimore, MD (Cˇiháková, Talor); the Spring Grove Hospital Center, Baltimore, MD (Richardson, Vyas, Adams); the Center for Celiac Research and Treatment, Massachusetts General Hospital, Boston, MA (Fasano); the Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD (Cascella); the Department of Psychology, Kent State University, Kent, OH (Sayer).'}, {'ForeName': 'William W.', 'Initials': 'WW', 'LastName': 'Eaton', 'Affiliation': 'From the Maryland Psychiatric Research Center (MPRC), School of Medicine, University of Maryland, College Park, MD (Kelly, McMahon, August, Feldman, Liu, Powell, Wehring, Buchanan, Gold, Carpenter); the Department of Orthopedics, School of Medicine, University of Maryland, College Park, MD (Demyanovich); the Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD (Rodriguez, Eaton); the Department of Pathology, Division of Immunology, Immune Disorders Laboratory, Johns Hopkins University, Baltimore, MD (Cˇiháková, Talor); the Spring Grove Hospital Center, Baltimore, MD (Richardson, Vyas, Adams); the Center for Celiac Research and Treatment, Massachusetts General Hospital, Boston, MA (Fasano); the Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD (Cascella); the Department of Psychology, Kent State University, Kent, OH (Sayer).'}]",Journal of psychiatry & neuroscience : JPN,[]
507,32273276,Evaluation of Cyclophosphamide/GVAX Pancreas Followed by Listeria-Mesothelin (CRS-207) with or without Nivolumab in Patients with Pancreatic Cancer.,"PURPOSE


Two studies in previously treated metastatic pancreatic cancer have been completed combining GVAX pancreas vaccine (GM-CSF-secreting allogeneic pancreatic tumor cells) with cyclophosphamide (Cy) and CRS-207 (live, attenuated  Listeria monocytogenes -expressing mesothelin). In the current study, we compared Cy/GVAX followed by CRS-207 with (Arm A) or without nivolumab (Arm B).
EXPERIMENTAL DESIGN


Patients with pancreatic adenocarcinoma who received one prior therapy for metastatic disease and RECIST measurable disease were randomized 1:1 to receive treatment on Arm A or Arm B. The primary objective was to compare overall survival (OS) between the arms. Additional objectives included assessment of progression-free survival, safety, tumor responses, CA19-9 responses, and immunologic correlates.
RESULTS


Ninety-three patients were treated (Arm A, 51; Arm B, 42). The median OS in Arms A and B were 5.9 [95% confidence interval (CI), 4.7-8.6] and 6.1 (95% CI, 3.5-7.0) months, respectively, with an HR of 0.86 (95% CI, 0.55-1.34). Objective responses were seen in 3 patients using immune-related response criteria (4%, 2/51, Arm A; 2%, 1/42, Arm B). The grade ≥3 related adverse event rate, whereas higher in Arm A (35.3% vs. 11.9%) was manageable. Changes in the microenvironment, including increase in CD8 +  T cells and a decrease in CD68 +  myeloid cells, were observed in long-term survivors in Arm A only.
CONCLUSIONS


Although the study did not meet its primary endpoint of improvement in OS of Arm A over Arm B, the OS was comparable with standard therapy. Objective responses and immunologic changes in the tumor microenvironment were evident.",2020,"Changes in the microenvironment, including increase in CD8 +  T cells and a decrease in CD68 +  myeloid cells, were observed in long-term survivors in Arm A only.
","['previously-treated metastatic pancreatic cancer', 'Patients with pancreatic adenocarcinoma who received one prior therapy for metastatic disease and RECIST measurable disease', 'Patients with Pancreatic Cancer']","['Cyclophosphamide/GVAX Pancreas Followed by Listeria-mesothelin (CRS-207', 'GVAX pancreas vaccine (granulocyte-macrophage colony-stimulating factor-secreting allogeneic pancreatic tumor cells) with cyclophosphamide (Cy) and CRS-207']","['adverse event rate', 'CD8 +  T cells', 'progression-free survival, safety, tumor responses, CA19-9 responses and immunologic correlates', 'overall survival (OS', 'Objective responses', 'CD68 +  myeloid cells', 'median OS']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0346976', 'cui_str': 'Secondary malignant neoplasm of pancreas'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0281361', 'cui_str': 'Adenocarcinoma of pancreas'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0771711', 'cui_str': 'Pancreas extract'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0023859', 'cui_str': 'Listeria'}, {'cui': 'C0380162', 'cui_str': 'mesothelin'}, {'cui': 'C0010278', 'cui_str': 'Craniosynostosis syndrome'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0018183', 'cui_str': 'Granulocyte'}, {'cui': 'C0079784', 'cui_str': 'Colony-stimulating factor, macrophage'}, {'cui': 'C0030297', 'cui_str': 'Neoplasm of pancreas'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0006613', 'cui_str': 'Cancer antigen 19-9'}, {'cui': 'C0152036', 'cui_str': 'Immunology'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0108799', 'cui_str': 'Lymphocyte antigen CD68'}, {'cui': 'C0596993', 'cui_str': 'Stem Cells, Myeloid'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",93.0,0.0916246,"Changes in the microenvironment, including increase in CD8 +  T cells and a decrease in CD68 +  myeloid cells, were observed in long-term survivors in Arm A only.
","[{'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Tsujikawa', 'Affiliation': 'Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Crocenzi', 'Affiliation': 'Providence Portland Medical Center, Portland, Oregon.'}, {'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Durham', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Sugar', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Annie A', 'Initials': 'AA', 'LastName': 'Wu', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Onners', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Nauroth', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Anders', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Elana J', 'Initials': 'EJ', 'LastName': 'Fertig', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Laheru', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Reiss', 'Affiliation': 'Abramson Cancer Center at the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Vonderheide', 'Affiliation': 'Abramson Cancer Center at the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Ko', 'Affiliation': 'University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Tempero', 'Affiliation': 'University of California San Francisco, San Francisco, California.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Fisher', 'Affiliation': 'Stanford University, Palo Alto, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Considine', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Ludmila', 'Initials': 'L', 'LastName': 'Danilova', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Dirk G', 'Initials': 'DG', 'LastName': 'Brockstedt', 'Affiliation': 'Aduro Biotech Inc., Berkeley, California.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Coussens', 'Affiliation': 'Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Jaffee', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Dung T', 'Initials': 'DT', 'LastName': 'Le', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland. dle@jhmi.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-3978']
508,31826241,Impact of NPM1/FLT3-ITD genotypes defined by the 2017 European LeukemiaNet in patients with acute myeloid leukemia.,"Patients with acute myeloid leukemia (AML) harboring FLT3 internal tandem duplications (ITDs) have poor outcomes, in particular AML with a high (≥0.5) mutant/wild-type allelic ratio (AR). The 2017 European LeukemiaNet (ELN) recommendations defined 4 distinct FLT3-ITD genotypes based on the ITD AR and the NPM1 mutational status. In this retrospective exploratory study, we investigated the prognostic and predictive impact of the NPM1/FLT3-ITD genotypes categorized according to the 2017 ELN risk groups in patients randomized within the RATIFY trial, which evaluated the addition of midostaurin to standard chemotherapy. The 4 NPM1/FLT3-ITD genotypes differed significantly with regard to clinical and concurrent genetic features. Complete ELN risk categorization could be done in 318 of 549 trial patients with FLT3-ITD AML. Significant factors for response after 1 or 2 induction cycles were ELN risk group and white blood cell (WBC) counts; treatment with midostaurin had no influence. Overall survival (OS) differed significantly among ELN risk groups, with estimated 5-year OS probabilities of 0.63, 0.43, and 0.33 for favorable-, intermediate-, and adverse-risk groups, respectively (P < .001). A multivariate Cox model for OS using allogeneic hematopoietic cell transplantation (HCT) in first complete remission as a time-dependent variable revealed treatment with midostaurin, allogeneic HCT, ELN favorable-risk group, and lower WBC counts as significant favorable factors. In this model, there was a consistent beneficial effect of midostaurin across ELN risk groups.",2020,"Overall survival (OS) differed significantly between ELN risk groups with estimated 5-year OS probabilities of 0.63, 0.43, and 0.33 for favorable-, intermediate- and adverse-risk groups, respectively (P<0.001).","['318 of 549 trial patients with FLT3-ITD AML', '2017 European LeukemiaNet (ELN) recommendations defined four distinct FLT3-ITD genotypes based on the ITD-AR and the NPM1 mutational status', 'Patients with AML harboring FLT3 internal tandem duplications (ITD', 'patients with acute myeloid leukemia']","['allogeneic hematopoietic-cell transplantation (HCT', 'NPM1/FLT3-ITD', 'midostaurin to standard chemotherapy']","['5-year OS probabilities', 'Overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0475311', 'cui_str': 'Harbor (environment)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0332597', 'cui_str': 'Duplication (finding)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}]","[{'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}, {'cui': 'C0526371', 'cui_str': 'midostaurin'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0364359,"Overall survival (OS) differed significantly between ELN risk groups with estimated 5-year OS probabilities of 0.63, 0.43, and 0.33 for favorable-, intermediate- and adverse-risk groups, respectively (P<0.001).","[{'ForeName': 'Konstanze', 'Initials': 'K', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Thiede', 'Affiliation': 'Department of Internal Medicine I, University Hospital Carl Gustav Carus, Dresden, Germany.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Jahn', 'Affiliation': 'Department of Internal Medicine III, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Panina', 'Affiliation': 'Department of Internal Medicine III, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Gambietz', 'Affiliation': 'Division of Biostatistics, German Cancer Research Center Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Larson', 'Affiliation': 'Department of Medicine and Comprehensive Cancer Research Center, University of Chicago, Chicago, IL.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Prior', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, OH.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Marcucci', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, OH.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Jones', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, OH.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Krauter', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Heuser', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Voso', 'Affiliation': 'Department of Biomedicine and Prevention, Università di Roma ""Tor Vergata,"" Rome, Italy.'}, {'ForeName': 'Tiziana', 'Initials': 'T', 'LastName': 'Ottone', 'Affiliation': 'Department of Biomedicine and Prevention, Università di Roma ""Tor Vergata,"" Rome, Italy.'}, {'ForeName': 'Josep F', 'Initials': 'JF', 'LastName': 'Nomdedeu', 'Affiliation': 'Hematology Department, Hospital de la Santa Creu i Sant Pau, IIB-Santpau and Jose Carreras Leukemia Research Institutes, Autonomus University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Sumithra J', 'Initials': 'SJ', 'LastName': 'Mandrekar', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Rebecca B', 'Initials': 'RB', 'LastName': 'Klisovic', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, OH.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Wei', 'Affiliation': 'Department of Clinical Hematology, The Alfred Hospital and Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Sierra', 'Affiliation': 'Hematology Department, Hospital de la Santa Creu i Sant Pau, IIB-Santpau and Jose Carreras Leukemia Research Institutes, Autonomus University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Sanz', 'Affiliation': 'Instituto de Investigación Sanitaria La Fe, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Brandwein', 'Affiliation': 'Department of Medical Oncology and Hematology, Princess Margaret Hospital, Toronto, ON, Canada.'}, {'ForeName': 'Theo', 'Initials': 'T', 'LastName': 'de Witte', 'Affiliation': 'Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Joop H', 'Initials': 'JH', 'LastName': 'Jansen', 'Affiliation': 'Laboratory Hematology, Deptartment of Laboratory Medicine, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Dietger', 'Initials': 'D', 'LastName': 'Niederwieser', 'Affiliation': 'Department of Hematology, Oncology, and Hemostasis, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Frederick R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Bruno C', 'Initials': 'BC', 'LastName': 'Medeiros', 'Affiliation': 'Division of Hematology, Stanford Comprehensive Cancer Center, Stanford University, Stanford, CA.'}, {'ForeName': 'Martin S', 'Initials': 'MS', 'LastName': 'Tallman', 'Affiliation': 'Leukemia Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Schlenk', 'Affiliation': 'Department of Internal Medicine III, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Ganser', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Serve', 'Affiliation': 'Department of Medicine, Hematology/Oncology, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Ehninger', 'Affiliation': 'Department of Internal Medicine I, University Hospital Carl Gustav Carus, Dresden, Germany.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Amadori', 'Affiliation': 'Department of Biomedicine and Prevention, Università di Roma ""Tor Vergata,"" Rome, Italy.'}, {'ForeName': 'Insa', 'Initials': 'I', 'LastName': 'Gathmann', 'Affiliation': 'Novartis Pharmaceuticals, Basel, Switzerland; and.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Benner', 'Affiliation': 'Division of Biostatistics, German Cancer Research Center Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Pallaud', 'Affiliation': 'Novartis Pharmaceuticals, Basel, Switzerland; and.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Stone', 'Affiliation': 'Department of Medical Oncology, Dana-Farber/Partners CancerCare, Boston, MA.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Clara D', 'Initials': 'CD', 'LastName': 'Bloomfield', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, OH.'}]",Blood,['10.1182/blood.2019002697']
509,32274958,Exploring the Relation Between Teacher Factors and Student Growth in Early Writing.,"Data from a small randomized control trial of teachers' use of Data-Based Instruction (DBI) for early writing were analyzed to determine the influence of teacher knowledge, skills, and treatment fidelity on student Curriculum-Based Measurement (CBM) slope. Participants included 11 elementary grade teachers who delivered intensive intervention in early writing and their students ( n  = 31), all identified as either at risk for or with disabilities that affect their writing. Teachers received professional development and ongoing coaching to support the implementation of DBI for improving their students' early writing skills. Results from a multiple regression analysis suggest that teacher knowledge and skills in DBI was strongly related to student CBM slope in early writing ( p  < .01) and a small but significant relation between fidelity of writing instruction and student CBM slope ( p  < .01). Implications for instructional coaching and improving student writing progress are discussed.",2020,Teachers received professional development and ongoing coaching to support the implementation of DBI for improving their students' early writing skills.,"['Participants included 11 elementary grade teachers who delivered intensive intervention in early writing and their students ( n  = 31), all identified as either at risk for or with disabilities that affect their writing']","['Data-Based Instruction (DBI', ""professional development and ongoing coaching to support the implementation of DBI for improving their students' early writing skills"", 'instructional coaching']","['student CBM slope', 'teacher knowledge and skills in DBI', 'fidelity of writing instruction and student CBM slope']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0521125', 'cui_str': 'For'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0043266', 'cui_str': 'Writing'}]",,0.0209805,Teachers received professional development and ongoing coaching to support the implementation of DBI for improving their students' early writing skills.,"[{'ForeName': 'Britta Cook', 'Initials': 'BC', 'LastName': 'Bresina', 'Affiliation': 'University of Minnesota, Minneapolis, USA.'}, {'ForeName': 'Kristen L', 'Initials': 'KL', 'LastName': 'McMaster', 'Affiliation': 'University of Minnesota, Minneapolis, USA.'}]",Journal of learning disabilities,['10.1177/0022219420913543']
510,32150549,Fecal microbiota transplantation for the improvement of metabolism in obesity: The FMT-TRIM double-blind placebo-controlled pilot trial.,"BACKGROUND


There is intense interest about whether modulating gut microbiota can impact systemic metabolism. We investigated the safety of weekly oral fecal microbiota transplantation (FMT) capsules from healthy lean donors and their ability to alter gut microbiota and improve metabolic outcomes in patients with obesity.
METHODS AND FINDINGS


FMT-TRIM was a 12-week double-blind randomized placebo-controlled pilot trial of oral FMT capsules performed at a single US academic medical center. Between August 2016 and April 2018, we randomized 24 adults with obesity and mild-moderate insulin resistance (homeostatic model assessment of insulin resistance [HOMA-IR] between 2.0 and 8.0) to weekly healthy lean donor FMT versus placebo capsules for 6 weeks. The primary outcome, assessed by intention to treat, was change in insulin sensitivity between 0 and 6 weeks as measured by hyperinsulinemic euglycemic clamps. Additional metabolic parameters were evaluated at 0, 6, and 12 weeks, including HbA1c, body weight, body composition by dual-energy X-ray absorptiometry, and resting energy expenditure by indirect calorimetry. Fecal samples were serially collected and evaluated via 16S V4 rRNA sequencing. Our study population was 71% female, with an average baseline BMI of 38.8 ± 6.7 kg/m2 and 41.3 ± 5.1 kg/m2 in the FMT and placebo groups, respectively. There were no statistically significant improvements in insulin sensitivity in the FMT group compared to the placebo group (+5% ± 12% in FMT group versus -3% ± 32% in placebo group, mean difference 9%, 95% CI -5% to 28%, p = 0.16). There were no statistically significant differences between groups for most of the other secondary metabolic outcomes, including HOMA-IR (mean difference 0.2, 95% CI -0.9 to 0.9, p = 0.96) and body composition (lean mass mean difference -0.1 kg, 95% CI -1.9 to 1.6 kg, p = 0.87; fat mass mean difference 1.2 kg, 95% CI -0.6 to 3.0 kg, p = 0.18), over the 12-week study. We observed variable engraftment of donor bacterial groups among FMT recipients, which persisted throughout the 12-week study. There were no significant differences in adverse events (AEs) (10 versus 5, p = 0.09), and no serious AEs related to FMT. Limitations of this pilot study are the small sample size, inclusion of participants with relatively mild insulin resistance, and lack of concurrent dietary intervention.
CONCLUSIONS


Weekly administration of FMT capsules in adults with obesity results in gut microbiota engraftment in most recipients for at least 12 weeks. Despite engraftment, we did not observe clinically significant metabolic effects during the study.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02530385.",2020,"There were no significant differences in adverse events (AEs) (10 versus 5, p = 0.09), and no serious AEs related to FMT.","['participants with relatively mild insulin resistance, and lack of concurrent dietary intervention', 'healthy lean donors', 'Between August 2016 and April 2018, we randomized 24 adults with obesity and mild-moderate insulin resistance (homeostatic model assessment of insulin resistance [HOMA-IR] between 2.0 and 8.0) to weekly healthy lean donor', 'patients with obesity', 'obesity', 'Our study population was 71% female, with an average baseline BMI of 38.8 ± 6.7 kg/m2 and 41.3 ± 5.1 kg/m2 in the FMT and placebo groups, respectively', 'FMT-TRIM']","['FMT capsules', 'oral FMT', 'placebo', 'FMT', 'FMT versus placebo', 'oral fecal microbiota transplantation (FMT) capsules', 'Fecal microbiota transplantation']","['hyperinsulinemic euglycemic clamps', 'insulin sensitivity', 'HbA1c, body weight, body composition by dual-energy X-ray absorptiometry, and resting energy expenditure by indirect calorimetry', 'gut microbiota engraftment', 'body composition', 'HOMA-IR', 'adverse events (AEs', 'metabolic outcomes']","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441645', 'cui_str': 'Trimming - action (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2242628', 'cui_str': 'Fecal Transplantation'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}]","[{'cui': 'C0079318', 'cui_str': 'Glucose Clamp'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0006781', 'cui_str': 'Calorimetry, Respiration'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",24.0,0.712521,"There were no significant differences in adverse events (AEs) (10 versus 5, p = 0.09), and no serious AEs related to FMT.","[{'ForeName': 'Elaine W', 'Initials': 'EW', 'LastName': 'Yu', 'Affiliation': 'Endocrine Unit, Division of Endocrinology and Metabolism, Massachusetts General Hospital, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Endocrine Unit, Division of Endocrinology and Metabolism, Massachusetts General Hospital, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Stastka', 'Affiliation': 'Endocrine Unit, Division of Endocrinology and Metabolism, Massachusetts General Hospital, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Cheney', 'Affiliation': 'Endocrine Unit, Division of Endocrinology and Metabolism, Massachusetts General Hospital, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Mahabamunuge', 'Affiliation': 'Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Torres Soto', 'Affiliation': 'Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Ford', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts, United States of America.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Bryant', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts, United States of America.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Henn', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts, United States of America.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Hohmann', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts, United States of America.'}]",PLoS medicine,['10.1371/journal.pmed.1003051']
511,32243379,The microcirculatory characteristics of the heart and lung meridians: Study protocol clinical trial (SPIRIT Compliant).,"INTRODUCTION


The aim of the present study is to compare the microcirculatory difference of different meridians by using laser doppler flowmetry and investigate the specificity for the meridian-visceral association and site-to-site association between 2 specific meridians.
METHODS AND ANALYSIS


The Lung and Heart meridians are chosen as 2 specific studied meridians. 120 participants will be enrolled and divided into the healthy control group, chronic stable angina pectoris group and healthy intervention group. Laser doppler flowmetry will be used to assess the blood perfusion of the Heart and Lung meridians. The specificity for the meridian-visceral association will be investigated by comparing the microcirculatory difference between the Heart and Lung meridians in the healthy control group and chronic stable angina pectoris group. Besides, participants in the healthy intervention group will receive 2 sessions of moxibustion in the Heart meridian and Lung meridian, respectively, to explore the specificity for the site-to-site association on the body surface. Primary outcomes will be blood flow curve and blood perfusion units of relevant sites along the Heart and Lung meridians. Statistical analysis will be conducted by third party statisticians.
ETHICS AND DISSEMINATION


Ethics approval (approval No: ZSLL-KY-2019-001A-01) has been obtained from the Ethics Committee of the Third Affiliated Hospital of Zhejiang Chinese Medical University. The study findings will be disseminated through presentation at peer-reviewed medical journals.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04244812.",2020,"120 participants will be enrolled and divided into the healthy control group, chronic stable angina pectoris group and healthy intervention group.","['120 participants will be enrolled and divided into the healthy control group, chronic stable angina pectoris group and healthy intervention group']","['laser doppler flowmetry', 'Laser doppler flowmetry']",['blood flow curve and blood perfusion units of relevant sites along the Heart and Lung meridians'],"[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0162520', 'cui_str': 'Laser doppler flowmetry'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0085282', 'cui_str': 'Jingluo'}]",120.0,0.0346416,"120 participants will be enrolled and divided into the healthy control group, chronic stable angina pectoris group and healthy intervention group.","[{'ForeName': 'Hantong', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou City, Zhejiang Province.'}, {'ForeName': 'Yongliang', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Neurobiology and Acupuncture Research, The Third Clinical Medical College, Zhejiang Chinese Medical University, Key Laboratory of Acupuncture and Neurology of Zhejiang Province, Hangzhou, China.'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Neurobiology and Acupuncture Research, The Third Clinical Medical College, Zhejiang Chinese Medical University, Key Laboratory of Acupuncture and Neurology of Zhejiang Province, Hangzhou, China.'}, {'ForeName': 'Jiali', 'Initials': 'J', 'LastName': 'Lou', 'Affiliation': 'Department of Neurobiology and Acupuncture Research, The Third Clinical Medical College, Zhejiang Chinese Medical University, Key Laboratory of Acupuncture and Neurology of Zhejiang Province, Hangzhou, China.'}, {'ForeName': 'Yajun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurobiology and Acupuncture Research, The Third Clinical Medical College, Zhejiang Chinese Medical University, Key Laboratory of Acupuncture and Neurology of Zhejiang Province, Hangzhou, China.'}, {'ForeName': 'Xiaofen', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Neurobiology and Acupuncture Research, The Third Clinical Medical College, Zhejiang Chinese Medical University, Key Laboratory of Acupuncture and Neurology of Zhejiang Province, Hangzhou, China.'}, {'ForeName': 'Junfan', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Department of Neurobiology and Acupuncture Research, The Third Clinical Medical College, Zhejiang Chinese Medical University, Key Laboratory of Acupuncture and Neurology of Zhejiang Province, Hangzhou, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou City, Zhejiang Province.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Shao', 'Affiliation': 'Department of Neurobiology and Acupuncture Research, The Third Clinical Medical College, Zhejiang Chinese Medical University, Key Laboratory of Acupuncture and Neurology of Zhejiang Province, Hangzhou, China.'}, {'ForeName': 'Jianqiao', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Department of Neurobiology and Acupuncture Research, The Third Clinical Medical College, Zhejiang Chinese Medical University, Key Laboratory of Acupuncture and Neurology of Zhejiang Province, Hangzhou, China.'}]",Medicine,['10.1097/MD.0000000000019594']
512,32221052,Evaluation of Vascular Endothelial Growth Factor (VEGF) and Thrombospondin-1 as Biomarkers of Metronomic Chemotherapy in Progressive Pediatric Solid Malignancies.,"OBJECTIVE


We compared Vascular Endothelial Growth factor (VEGF) and Thrombospondin-1 between patients with progressive paediatric malignancies randomized to metronomic chemotherapy versus placebo to determine their role as biomarker.
METHODS


In this double-blinded, placebo-controlled randomized study of 108 progressive pediatric malignancies, serum VEGF and thrombospondin-1 levels were evaluated using ELISA at baseline, A2 (week-9 or earlier if progressed) and A3 (week-18 or earlier if progressed).
RESULTS


Mean VEGF and thrombospondin-1 at baseline, A2 and A3 and the change from baseline to A2 were not different between two groups. In metronomic arm, responders (those completing 3 cycles) had significantly lower mean (SD) baseline VEGF levels [659.7(362.1) vs 1143.9 (622.0) µg/mL] (P=0.002) and significant decrease in thrombospondin-1 from baseline to A2 [-4.43(8.0) µg/mL vs 1.7(11.3) µg/mL] (P=0.04), as compared to non-responders. Similar changes were not observed in responders on placebo arm. No consistent trend of these biomarkers was observed.
CONCLUSIONS


VEGF and thrombospondin-1 are not reliable biomarkers for response to metronomic chemotherapy.",2020,"In metronomic arm, responders (those completing 3 cycles) had significantly lower mean (SD) baseline VEGF levels [659.7(362.1) vs 1143.9 (622.0) μg/mL] (P=0.002) and significant decrease in thrombospondin-1 from baseline to A2 [-4.43(8.0) μg","['Progressive Pediatric Solid Malignancies', '108 progressive pediatric malignancies, serum VEGF and Thrombospondin-1 levels were evaluated using ELISA at baseline, A2 (week-9 or earlier if progressed) and A3 (week-18 or earlier if progressed', 'patients with progressive paediatric malignancies']","['placebo', 'Vascular Endothelial Growth Factor (VEGF) and Thrombospondin-1', 'VEGF and Thrombospondin-1', 'metronomic chemotherapy versus placebo', 'Vascular Endothelial Growth factor (VEGF) and Thrombospondin-1']","['thrombospondin-1', 'mean (SD) baseline VEGF levels', 'Mean VEGF and Thrombospondin-1']","[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0147139', 'cui_str': 'TSP-1'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0147139', 'cui_str': 'TSP-1'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0147139', 'cui_str': 'TSP-1'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",108.0,0.348687,"In metronomic arm, responders (those completing 3 cycles) had significantly lower mean (SD) baseline VEGF levels [659.7(362.1) vs 1143.9 (622.0) μg/mL] (P=0.002) and significant decrease in thrombospondin-1 from baseline to A2 [-4.43(8.0) μg","[{'ForeName': 'Raja', 'Initials': 'R', 'LastName': 'Pramanik', 'Affiliation': 'Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Anudishi', 'Initials': 'A', 'LastName': 'Tyagi', 'Affiliation': 'Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Agarwala', 'Affiliation': 'Department of Paediatric Surgrery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sreenivas', 'Initials': 'S', 'LastName': 'Vishnubhatla', 'Affiliation': 'Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Dhawan', 'Affiliation': 'Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Bakhshi', 'Affiliation': 'Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, India. Correspondence to: Dr Sameer Bakhshi, Professor of Pediatric Oncology, Department of Medical Oncology, Dr BRA Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi 110 029, India. sambakh@hotmail.com.'}]",Indian pediatrics,[]
513,32223010,Silver duct tape occlusion in treatment of plantar warts in adults: Is it effective?,"Duct tape occlusive therapy may represent a convenient alternative to the standard wart therapies. The objective of the current study is to assess the therapeutic effect of duct tape occlusion in comparison to cryotherapy in treatment of plantar warts in adults, in a prospective comparative randomized non-inferiority design. A total of 100 patients presenting with plantar warts were divided into two equal groups. First group was treated with silver duct tape occlusion for up to 8 weeks or disappearance of warts, whichever occurred first. Second group was treated with cryotherapy every 2 to 3 weeks for a maximum of four sessions or disappearance of warts. There was a statistically significant lower rate of complete resolution in duct tape than cryotherapy group (20% vs 58%, P = .0001, respectively). Degree of response to treatment in the duct tape and cryotherapy groups was not correlated to patients' age (P = .361 and .334, respectively) or disease duration (P = .266 and .285, respectively), while there was a statistically significant inverse relationship between the number (P = .0032 and .001, respectively) and diameter of warts (P = .013 and .003, respectively) and the degree of response in the two studied groups. Cryotherapy has higher efficacy than duct tape in the treatment of plantar warts in adults; however, duct tape may represent a practical and convenient alternative to cryotherapy in certain circumstances.",2020,"There was a statistically significant lower rate of complete resolution in duct tape than cryotherapy group (20% versus 58%, p=0.0001, respectively).","['plantar warts in adults', '100 patients presenting with plantar warts', 'Plantar Warts in Adults']","['Silver Duct Tape Occlusion', 'Cryotherapy', 'silver duct tape occlusion', 'cryotherapy', 'duct tape occlusion']","['Degree of response', 'disease duration', 'rate of complete resolution']","[{'cui': 'C0042548', 'cui_str': 'Verruca plantaris (disorder)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]","[{'cui': 'C0037125', 'cui_str': 'Silver'}, {'cui': 'C0687028', 'cui_str': 'Duct (organ) structure'}, {'cui': 'C1704747', 'cui_str': 'Tape (basic dose form)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}]","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",100.0,0.0197034,"There was a statistically significant lower rate of complete resolution in duct tape than cryotherapy group (20% versus 58%, p=0.0001, respectively).","[{'ForeName': 'Azmy A', 'Initials': 'AA', 'LastName': 'Abdel-Latif', 'Affiliation': 'Department of Dermatology, Venereology, and Andrology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Ahmed F', 'Initials': 'AF', 'LastName': 'El-Sherbiny', 'Affiliation': 'International Islamic Center for Population Studies and Research, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Ali H', 'Initials': 'AH', 'LastName': 'Omar', 'Affiliation': 'Department of Dermatology, Venereology, and Andrology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt.'}]",Dermatologic therapy,['10.1111/dth.13342']
514,32268161,Conventional Follow-up Versus Mobile App Home Monitoring for Postoperative Anterior Cruciate Ligament Reconstruction Patients: A Randomized Controlled Trial.,"PURPOSE


To determine whether a mobile app can reduce the need for in-person visits and examine the resulting societal cost differences between mobile and conventional follow-up for postoperative anterior cruciate ligament (ACL) reconstruction patients.
METHODS


Study design was a single-center, 2-arm parallel group randomized controlled trial. All patients undergoing ACL reconstruction aged 16 to 70 years were screened for inclusion in the study. Competent use of a mobile device and ability to communicate in English was required. Patients were randomly assigned to receive follow-up via a mobile app or conventional appointments. Analysis was intention-to-treat. The primary outcome was the number of in-person visits to any health care professional during the first 6 postoperative weeks. Secondary outcomes included analysis of costs incurred by the health care system and personal patient costs related to both methods of follow-up. Patient-reported satisfaction and convenience scores, rates of complications, and clinical outcomes were also analyzed.
RESULTS


Sixty patients were analyzed. Participants in the app group attended a mean of 0.36 in-person visits versus 2.44 in-person visits in the conventional group (95% confidence interval 0.08-0.28; P < .0001). On average, patients in the app group spent $211 (Canadian dollars) less than the conventional group over 6 weeks (P < .0001) on personal costs related to follow-up. Health care system costs were also significantly less in the app group ($157.5 vs CAD $202.2; P < .0001). There was no difference between groups in patient satisfaction, convenience, complication rates, or clinical outcome measures.
CONCLUSIONS


Mobile follow-up can eliminate a significant number of in-person visits during the first 6 postoperative weeks in patients undergoing ACL reconstruction with cost savings to both the patient and health care system. This method should be considered for dissemination among similar orthopaedic procedures during early postoperative care.
LEVEL OF EVIDENCE


I: Prospective randomized controlled trial.",2020,Healthcare system costs were also significantly less in the app group (CAD $157.5 versus CAD $202.2; p<0.0001).,"['Sixty patients were analyzed', 'All patients undergoing ACL reconstruction aged 16-70 were screened for inclusion in the study', 'for Post-Operative ACL Reconstruction Patients']","['Conventional Follow-up Versus Mobile App Home Monitoring', 'follow-up via a mobile app or through conventional appointments']","['patient satisfaction, convenience, complication rates, or clinical outcome measures', 'analysis of costs incurred by the healthcare system and personal patient costs related to both methods of follow-up', 'Healthcare system costs', 'number of in-person visits to any healthcare professional', 'satisfaction and convenience scores, rates of complications, and clinical outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",60.0,0.258303,Healthcare system costs were also significantly less in the app group (CAD $157.5 versus CAD $202.2; p<0.0001).,"[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Higgins', 'Affiliation': 'University of Toronto Orthopaedic Sports Medicine, Toronto, Ontario, Canada; Division of Orthopaedic Surgery, University of Toronto, Toronto, Ontario, Canada. Electronic address: james.higgins@one-mail.on.ca.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Chang', 'Affiliation': 'Division of Orthopaedic Surgery, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Hoit', 'Affiliation': 'Division of Orthopaedic Surgery, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jas', 'Initials': 'J', 'LastName': 'Chahal', 'Affiliation': ""University of Toronto Orthopaedic Sports Medicine, Toronto, Ontario, Canada; Division of Orthopaedic Surgery, University of Toronto, Toronto, Ontario, Canada; Division of Orthopaedic Surgery, Toronto Western Hospital, Toronto, Ontario, Canada; Division of Orthopaedic Surgery, Women's College Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Dwyer', 'Affiliation': ""University of Toronto Orthopaedic Sports Medicine, Toronto, Ontario, Canada; Division of Orthopaedic Surgery, University of Toronto, Toronto, Ontario, Canada; Division of Orthopaedic Surgery, Women's College Hospital, Toronto, Ontario, Canada; Division of Orthopaedic Surgery, Mount Sinai Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Theodoropoulos', 'Affiliation': ""University of Toronto Orthopaedic Sports Medicine, Toronto, Ontario, Canada; Division of Orthopaedic Surgery, University of Toronto, Toronto, Ontario, Canada; Division of Orthopaedic Surgery, Women's College Hospital, Toronto, Ontario, Canada; Division of Orthopaedic Surgery, Mount Sinai Hospital, Toronto, Ontario, Canada.""}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2020.02.045']
515,32268328,Effect of Lifestyle Interventions in Obese Pregnant Women on the Neurocognitive Development and Anthropometrics of Preschool Children.,"INTRODUCTION


Maternal obesity and excessive gestational weight gain are related to adverse outcomes in women and children. Lifestyle interventions during pregnancy showed positive effects on decreasing weight gain during pregnancy, but effects on offspring's health and wellbeing are unclear. We aimed to assess the effect of lifestyle intervention programmes on offspring mental health, temperament, eating habits and anthropometric and cardiovascular measures.
METHODS


Ninety-six offspring of pregnant women with a body mass index (BMI) ≥29 kg/m2 who were randomly assigned to 3 intervention groups during pregnancy (routine antenatal care, a brochure group or a prenatal session group) and 77 offspring of pregnant women with a normal BMI (between 18.5 and 24.9 kg/m2) were used as an additional control group in this analysis. When the children were between 3 and 7 years old, anthropometric and cardiovascular measurements were conducted and various questionnaires about offspring mental health, temperament and eating habits were filled out.
RESULTS


Children of mothers who received a brochure-based lifestyle intervention programme showed significantly less surgency/extraversion compared to children of mothers who received routine antenatal care (contrast estimate = -0.36, SE = 0.15, p = 0.02, 95% CI [-6.66, -0.06]) and prenatal lifestyle intervention sessions (contrast estimate = -0.46, SE = 0.14, p < 0.01, 95% CI [-0.74, -0.18]) after adjusting for child's age, sex, offspring birth weight and mother's educational level. The lifestyle intervention could not be associated with any significant differences in offspring mental health, eating habits and anthropometric and cardiovascular characteristics. Children of mothers with a normal BMI showed less emotional problems (F(1, 156) = 5.42, p = 0.02) and internalizing (F(1, 156) = 3.04, p = 0.08) and externalizing problems (F(1, 156) = 6.10, p = 0.02) when compared to children of mothers in the obese group.
DISCUSSION/CONCLUSION


The results suggest that a brochure-based lifestyle intervention programme can affect the offspring temperament. Future follow-up studies need to investigate how these temperament-related effects may influence obesity development later in life.",2020,"The lifestyle intervention could not be associated with any significant differences in offspring mental health, eating habits and anthropometric and cardiovascular characteristics.","['and 77 offspring of pregnant women with a normal BMI (between 18.5 and 24.9 kg/m2', 'Ninety-six offspring of pregnant women with a body mass index (BMI) ≥29 kg/m2 who', 'Children of mothers with a normal BMI', 'Obese Pregnant Women on the Neurocognitive Development and Anthropometrics of Preschool Children', 'women and children']","['Lifestyle Interventions', 'brochure-based lifestyle intervention programme', 'lifestyle intervention programmes', '3 intervention groups during pregnancy (routine antenatal care, a brochure group or a prenatal session group']","['prenatal lifestyle intervention sessions', 'offspring mental health, eating habits and anthropometric and cardiovascular characteristics', 'offspring mental health, temperament, eating habits and anthropometric and cardiovascular measures', 'surgency/extraversion', 'externalizing problems', 'emotional problems', 'weight gain']","[{'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517611', 'cui_str': '18.5'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1276362', 'cui_str': 'Routine antenatal care'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}]","[{'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0016468', 'cui_str': 'Eating Habits'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0039474', 'cui_str': 'Temperament'}, {'cui': 'C0199659', 'cui_str': 'Cardiovascular measure'}, {'cui': 'C0015382', 'cui_str': 'Extroversion, Psychological'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0677660', 'cui_str': 'Emotional problems'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",,0.064488,"The lifestyle intervention could not be associated with any significant differences in offspring mental health, eating habits and anthropometric and cardiovascular characteristics.","[{'ForeName': 'Marijke Anne Katrien Alberta', 'Initials': 'MAKA', 'LastName': 'Braeken', 'Affiliation': 'Research Unit Resilient People, Faculty of Health and Social Work, University Colleges Leuven-Limburg, Diepenbeek, Belgium.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Bogaerts', 'Affiliation': 'Department of Development and Regeneration, KU Leuven, Leuven, Belgium, annick.bogaerts@kuleuven.be.'}]",Obesity facts,['10.1159/000506690']
516,32268472,Effects of Acute Exercise on Cutaneous Thermal Sensation.,"The aim of this study was to assess the effect of exercise intensity on the thermal sensory function of active and inactive limbs. In a randomised and counterbalanced manner, 13 healthy young male participants (25 ± 6 years, 1.8 ± 0.1 m, 77 ± 6 kg) conducted: (1) 30-min low-intensity (50% heart rate maximum, HRmax; LOW) and (2) 30-min high-intensity (80% HRmax; HIGH) cycling exercises, and (3) 30 min of seated rest (CONTROL). Before, immediately after, and 1 h after, each intervention, thermal sensory functions of the non-dominant dorsal forearm and posterior calf were examined by increasing local skin temperature (1 °C/s) to assess perceptual heat sensitivity and pain thresholds. Relative to pre-exercise, forearm heat sensitivity thresholds were increased immediately and 1 hr after HIGH, but there were no changes after LOW exercise or during CONTROL (main effect of trial;  p  = 0.017). Relative to pre-exercise, calf heat sensitivity thresholds were not changed after LOW or HIGH exercise or during CONTROL (main effect of trial;  p  = 0.629). There were no changes in calf (main effect of trial;  p  = 0.528) or forearm (main effect of trial;  p  = 0.088) heat pain thresholds after exercise in either LOW or HIGH or CONTROL. These results suggest that cutaneous thermal sensitivity function of an inactive limb is only reduced after higher intensity exercise but is not changed in a previously active limb after exercise. Exercise does not affect heat pain sensitivity in either active or inactive limbs.",2020,There were no changes in calf (main effect of trial;  p  = 0.528) or forearm (main effect of trial;  p  = 0.088) heat pain thresholds after exercise in either LOW or HIGH or CONTROL.,"['13 healthy young male participants (25 ± 6 years, 1.8 ± 0.1 m, 77 ± 6 kg) conducted: (1']","['LOW or HIGH exercise', '30-min low-intensity (50% heart rate maximum, HRmax; LOW) and (2) 30-min high-intensity (80% HRmax; HIGH) cycling exercises, and (3) 30 min of seated rest (CONTROL', 'Acute Exercise']","['heat pain sensitivity', 'Cutaneous Thermal Sensation', 'heat pain thresholds', 'forearm heat sensitivity thresholds', 'local skin temperature', 'perceptual heat sensitivity and pain thresholds']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}]","[{'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0039478', 'cui_str': 'Thermal sensation, function'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0231274', 'cui_str': 'Intolerant of heat'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}]",13.0,0.115619,There were no changes in calf (main effect of trial;  p  = 0.528) or forearm (main effect of trial;  p  = 0.088) heat pain thresholds after exercise in either LOW or HIGH or CONTROL.,"[{'ForeName': 'Samuel D', 'Initials': 'SD', 'LastName': 'Thomas', 'Affiliation': 'Research Institute of Sports & Exercise Sciences, Liverpool John Moores University, Liverpool L3 3AF, UK.'}, {'ForeName': 'Howard H', 'Initials': 'HH', 'LastName': 'Carter', 'Affiliation': 'Research Institute of Sports & Exercise Sciences, Liverpool John Moores University, Liverpool L3 3AF, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Jones', 'Affiliation': 'Research Institute of Sports & Exercise Sciences, Liverpool John Moores University, Liverpool L3 3AF, UK.'}, {'ForeName': 'Dick H J', 'Initials': 'DHJ', 'LastName': 'Thijssen', 'Affiliation': 'Research Institute of Sports & Exercise Sciences, Liverpool John Moores University, Liverpool L3 3AF, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Low', 'Affiliation': 'Research Institute of Sports & Exercise Sciences, Liverpool John Moores University, Liverpool L3 3AF, UK.'}]",International journal of environmental research and public health,['10.3390/ijerph17072491']
517,31455225,Effects of individualized Tai-Chi on balance and lower-limb strength in older adults.,"BACKGROUND


To investigate whether a simplified and personalized Tai-Chi program could be beneficial for practitioners. A prospective quasi-experimental observer-blinded controlled trial was done in Beitou District of Taipei City.
METHODS


Community-dwelling adults aged 65 and older without debilitating disease (N = 50) participated the study. Those who were willing to participate in exercise program were assigned to individualized Tai-Chi (iTC) group (n = 20), receiving iTC training for 8 weeks, and traditional Tai-Chi (tTC) group (n = 15), receiving tTC training for 8 weeks. Those who were not willing to participate in exercise training were included in the control group (n = 15). Functional balance tests, the Berg Balance Scale (BBS), timed up-and-go (TUG) test, functional-reach test, and measurement of lower-extremity muscle strength were conducted before and 8 weeks after the intervention.
RESULTS


Significant improvements were noted in all functional balance tests and strength assessments of 16 major lower-limb muscle groups in participants of the iTC group compared to the control group, whereas only BBS and muscle strength of hips and ankles were improved in the tTC group. Practitioners of iTC outperformed tTC in BBS and strength of two major muscles.
CONCLUSIONS


Personalized Tai-Chi training designed based on an objective measurement and conducted according to graded intensity and complexity benefitted practitioners after a short period.
TRIAL REGISTRATION


Trial registration number: ClinicalTrials.gov ID: NCT03659396 , Unique Protocol ID: 1000087 Date of registration: 03/28/2017 The trial was registered retrospectively.",2019,"RESULTS


Significant improvements were noted in all functional balance tests and strength assessments of 16 major lower-limb muscle groups in participants of the iTC group compared to the control group, whereas only BBS and muscle strength of hips and ankles were improved in the tTC group.","['older adults', 'Community-dwelling adults aged 65 and older without debilitating disease (N\u2009=\u200950) participated the study', 'Beitou District of Taipei City']","['individualized Tai-Chi (iTC', 'simplified and personalized Tai-Chi program', 'exercise training', 'iTC training for 8 weeks, and traditional Tai-Chi (tTC', 'individualized Tai-Chi', 'tTC training']","['functional balance tests and strength assessments', 'BBS and muscle strength of hips and ankles', 'Functional balance tests, the Berg Balance Scale (BBS), timed up-and-go (TUG) test, functional-reach test, and measurement of lower-extremity muscle strength']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C1998271', 'cui_str': 'Functional reach test (procedure)'}, {'cui': 'C1828138', 'cui_str': 'Measurement of lower extremity'}]",,0.0473462,"RESULTS


Significant improvements were noted in all functional balance tests and strength assessments of 16 major lower-limb muscle groups in participants of the iTC group compared to the control group, whereas only BBS and muscle strength of hips and ankles were improved in the tTC group.","[{'ForeName': 'I-Wen', 'Initials': 'IW', 'LastName': 'Penn', 'Affiliation': 'School of Medicine, Fu Jen Catholic University, New Taipei City, 24205, Taiwan.'}, {'ForeName': 'Wen-Hsu', 'Initials': 'WH', 'LastName': 'Sung', 'Affiliation': 'Department of Physical Therapy and Assistive Technology, National Yang-Ming University, Taipei, 11221, Taiwan.'}, {'ForeName': 'Chien-Hui', 'Initials': 'CH', 'LastName': 'Lin', 'Affiliation': 'Department of Physical Therapy and Assistive Technology, National Yang-Ming University, Taipei, 11221, Taiwan.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Chuang', 'Affiliation': 'Department of Integrative Biology Alumnus, University of California, Berkeley, CA, 94720, USA.'}, {'ForeName': 'Tien-Yow', 'Initials': 'TY', 'LastName': 'Chuang', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, Taipei Veterans General Hospital and National Yang Ming University, Taipei, 11217, Taiwan.'}, {'ForeName': 'Pei-Hsin', 'Initials': 'PH', 'LastName': 'Lin', 'Affiliation': 'Center for Rehabilitation and Technical Aids, Taipei Veterans General Hospital, Taipei, 11217, Taiwan. phlin2@vghtpe.gov.tw.'}]",BMC geriatrics,['10.1186/s12877-019-1250-8']
518,32273381,Sexual Assault Prevention: A Randomized Control Trial of a Standard Military Intervention and a Motivational Interview Enhancement.,"Despite increased efforts to prevent sexual assault in military environments, the problem continues at an alarming rate. Sexual assault prevention programs (SAPP) attempt to respond to this issue, yet little is known about their effectiveness within a military environment. This randomized controlled trial examined the potential efficacy of the 2015 United States Air Force (USAF) SAPP compared to that same program with an additional motivational interviewing (MI) enhancement. The MI enhancement involved both self-guided and group discussions designed to elicit change talk toward preventing sexual assault through bystander interventions. Research questions included the general efficacy of the USAF's SAPP in shifting factors linked to sexual assault, specifically participants' endorsement of beliefs associated with sexual assault, beliefs eceived the pretest via e-mailabout intervening as a bystander when confronted with a hypothetical sexual assault situation, and participants' reported willingness to intervene to stop a sexual assault. Fifty-one college students participated, of whom 64% had a history of military involvement. Primary outcome measures included bystanders' willingness and confidence to intervene as well as indicators of rape myth acceptance. Participants in the standard USAF SAPP showed no significant change in willingness or confidence to intervene as bystanders from pretest to posttest. By contrast, those who received a relatively short MI enhancement showed statistically significant increases in their willingness to intervene as bystanders. Neither group showed changes in sexual assault myths. Enhancing SAPPs with a motivational enhancement effort seems justified, especially given the relative low resources involved in introducing such a program.",2020,Participants in the standard USAF SAPP showed no significant change in willingness or confidence to intervene as bystanders from pretest to posttest.,"['Fifty-one college students participated, of whom 64% had a history of military involvement']","['Standard Military Intervention and a Motivational Interview Enhancement', 'Sexual Assault Prevention', ""USAF's SAPP"", 'standard USAF SAPP', '2015 United States Air Force (USAF) SAPP compared to that same program with an additional motivational interviewing (MI) enhancement']","[""bystanders' willingness and confidence to intervene as well as indicators of rape myth acceptance"", 'sexual assault myths', 'willingness or confidence to intervene']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0237236', 'cui_str': 'Sexual assault'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0034668', 'cui_str': 'Forcible intercourse'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0237236', 'cui_str': 'Sexual assault'}]",,0.0191827,Participants in the standard USAF SAPP showed no significant change in willingness or confidence to intervene as bystanders from pretest to posttest.,"[{'ForeName': 'Christine R', 'Initials': 'CR', 'LastName': 'Gedney', 'Affiliation': 'Social Work, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Lundahl', 'Affiliation': 'Social Work, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Fawson', 'Affiliation': 'Social Work, Appalachian State University, Boone, North Carolina, USA fawsonpr@appstate.edu.'}]",Violence and victims,['10.1891/VV-D-18-00031']
519,32269011,Autologous fat graft assisted by stromal vascular fraction improves facial skin quality: A randomized controlled trial.,"BACKGROUND


Cell-assisted lipotransfer (CAL) promotes the survival of fat grafts with high vascular density and improves skin quality by increasing collagen content. However, no study has quantified the changes on the skin surface, and rigorous methodological evaluations are still lacking.
DESIGN


Fifty patients were recruited and randomly divided into two groups: an experimental group (n = 25) that underwent a stromal vascular fraction (SVF)-assisted fat graft and a control group (n = 25) that underwent fat graft only.
METHODS


The SVF cells were counted, tested in terms of viability, and characterized. The volumes of whole faces were determined by using a 3D scanner and Geomagic software preoperation, immediately after surgery, and 6 months postoperation. Facial skin qualities, including spots, wrinkles, texture, pores, UV spots, brown spots, red areas, and porphyrins, were detected by a VISIA skin detector preoperation and 6 months postoperation. A visual analog scale was used for clinical evaluation.
RESULTS


The cell pellet contained 1-3 × 10 7 /mL of fresh SVF cells. The cell viability exceeded 98%. The immunophenotyping characteristics and stemness were consistent with the features of adipose- derived stem cells (ADSCs). The survival rate of SVF-enriched fat grafts was significantly higher than that of control grafts: 77.6%±11.6% versus 56.2%±9.5% (p<0.001). The VISIA values of wrinkles (19.3 ± 6.6 versus 10.9 ± 5.5, p<0.001) and texture (15.8 ± 7.0 versus 10.3 ± 5.0, p<0.01) were significantly higher in SVF-enriched group than in control group at 6 months postoperation. During long-term follow-up, the majority of patients in both groups were satisfied with the final facial esthetic results.
CONCLUSIONS


Our results demonstrated the positive outcomes of autologous SVF-assisted fat graft in improving facial skin quality and its promising application potential in clinical settings. This study is registered at www. ClinicalTrials.gov, number NCT02923219.",2020,"During long-term follow-up, the majority of patients in both groups were satisfied with the final facial esthetic results.
",['Fifty patients'],"['autologous SVF-assisted fat graft', 'Cell-assisted lipotransfer (CAL', 'Autologous fat graft assisted by stromal vascular fraction', 'stromal vascular fraction (SVF)-assisted fat graft and a control group (n\u202f=\u202f25) that underwent fat graft only']","['VISIA values of wrinkles', 'survival rate of SVF-enriched fat grafts', 'Facial skin qualities, including spots, wrinkles, texture, pores, UV spots, brown spots, red areas, and porphyrins', 'skin quality', 'cell viability', 'facial skin quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0844767', 'cui_str': 'Grafting of fat'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C4076692', 'cui_str': 'Autologous fat'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0844767', 'cui_str': 'Grafting of fat'}, {'cui': 'C0222084', 'cui_str': 'Skin structure of face'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0032712', 'cui_str': 'Porphyrin'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0007620', 'cui_str': 'Cell Viability'}]",50.0,0.137992,"During long-term follow-up, the majority of patients in both groups were satisfied with the final facial esthetic results.
","[{'ForeName': 'Yating', 'Initials': 'Y', 'LastName': 'Yin', 'Affiliation': 'Department of Plastic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huai-hai West Road, 221002 Xuzhou, Jiangsu, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Plastic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huai-hai West Road, 221002 Xuzhou, Jiangsu, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Plastic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huai-hai West Road, 221002 Xuzhou, Jiangsu, China.'}, {'ForeName': 'Aijun', 'Initials': 'A', 'LastName': 'Zhang', 'Affiliation': 'Department of Plastic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huai-hai West Road, 221002 Xuzhou, Jiangsu, China. Electronic address: zaj165@126.com.'}, {'ForeName': 'Peisheng', 'Initials': 'P', 'LastName': 'Jin', 'Affiliation': 'Department of Plastic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huai-hai West Road, 221002 Xuzhou, Jiangsu, China. Electronic address: 100000401006@xzhmu.edu.cn.'}]","Journal of plastic, reconstructive & aesthetic surgery : JPRAS",['10.1016/j.bjps.2019.11.010']
520,32243651,Studying the effect of adding growth factors to the autologous melanocyte keratinocyte suspension in segmental vitiligo.,"Addition of different growth factors to the medium used in autologous melanocyte-keratinocyte transplantation procedure (MKTP) was reported in the literature. The aim of the current study was comparison of response to MKTP in segmental vitiligo (SV) with and without adding growth factors to the suspension medium. Eighteen cases with SV were randomly divided into two groups. In group A: Ham F12 medium was used for suspension and in group B: 5 ng/mL recombinant basic fibroblast growth factor (bFGF) and 25 mg/500 mL 3'5' cyclic adenosine monophosphate (cAMP) were added to the medium. All cases received NB-UVB twice weekly for 24 weeks. The area of vitiligo lesions was measured before and after therapy by point-counting technique and complications were recorded. Excellent response (90%-100% repigmentation) occurred in 5/9 cases (56%) in group A and 7/9 cases (78%) in group B (with growth factors). A significant decrease in the area of treated lesions before and after therapy was found in both groups A and B (P = .0012 and .0004, respectively), however, a higher percentage of reduction in area of vitiligo was seen in group B cases (70% in group A vs 90% in group B; P value: .028). Marginal halo was seen in five cases in group A and six in group B. In conclusion addition of bFGF and cAMP to MKTP medium improved the results of the procedure. It could be considered if economically feasible.",2020,"A significant decrease in area of treated lesions before and after therapy was found in both groups A and B (P = 0.0012 & 0.0004 respectively), however a higher percentage of reduction in area of vitiligo was seen in group B cases (70% in group A vs 90% in group B; p value: 0.028).","['Segmental Vitiligo', '18 cases with SV', 'segmental vitiligo (SV']","['bFGF', 'autologous melanocyte-keratinocyte transplantation procedure (MKTP', 'NB-UVB', 'Autologous Melanocyte Keratinocyte Suspension', 'MKTP', ""mL 3'5'cyclic adenosine monophosphate"", 'mL recombinant basic fibroblast growth factor (bFGF) and 25']","['area of vitiligo', 'area of vitiligo lesions', 'Excellent response', 'Marginal halo', 'area of treated lesions']","[{'cui': 'C1274648', 'cui_str': 'Segmental vitiligo'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0380603', 'cui_str': 'Fibroblast Growth Factor-2'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0025201', 'cui_str': 'Melanocyte'}, {'cui': 'C0022567', 'cui_str': 'Keratinocyte'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0454530', 'cui_str': 'Ultraviolet B therapy'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0001465', 'cui_str': 'Adenosine phosphate'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0181278', 'cui_str': 'Halo brace'}]",18.0,0.0191867,"A significant decrease in area of treated lesions before and after therapy was found in both groups A and B (P = 0.0012 & 0.0004 respectively), however a higher percentage of reduction in area of vitiligo was seen in group B cases (70% in group A vs 90% in group B; p value: 0.028).","[{'ForeName': 'Samia', 'Initials': 'S', 'LastName': 'Esmat', 'Affiliation': 'Department of Dermatology, Kasr El-Ainy Teaching Hospital, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Dalia', 'Initials': 'D', 'LastName': 'Bassiouny', 'Affiliation': 'Department of Dermatology, Kasr El-Ainy Teaching Hospital, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Marwah A', 'Initials': 'MA', 'LastName': 'Saleh', 'Affiliation': 'Department of Dermatology, Kasr El-Ainy Teaching Hospital, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Dalia', 'Initials': 'D', 'LastName': 'AbdelHalim', 'Affiliation': 'Department of Dermatology, Kasr El-Ainy Teaching Hospital, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Rehab', 'Initials': 'R', 'LastName': 'Hegazy', 'Affiliation': 'Department of Dermatology, Kasr El-Ainy Teaching Hospital, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'ElHawary', 'Affiliation': 'Department of Dermatology, Kasr El-Ainy Teaching Hospital, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Heba', 'Initials': 'H', 'LastName': 'Gawdat', 'Affiliation': 'Department of Dermatology, Kasr El-Ainy Teaching Hospital, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Heba', 'Initials': 'H', 'LastName': 'Gouda', 'Affiliation': 'Department of Clinical Pathology, Kasr El-Ainy Teaching Hospital, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mervat', 'Initials': 'M', 'LastName': 'Khorshied', 'Affiliation': 'Department of Clinical Pathology, Kasr El-Ainy Teaching Hospital, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Nesrin', 'Initials': 'N', 'LastName': 'Samir', 'Affiliation': 'Department of Dermatology, Kasr El-Ainy Teaching Hospital, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",Dermatologic therapy,['10.1111/dth.13368']
521,32271354,Efficacy and Safety of Pembrolizumab Plus Docetaxel vs Docetaxel Alone in Patients With Previously Treated Advanced Non-Small Cell Lung Cancer: The PROLUNG Phase 2 Randomized Clinical Trial.,"Importance


Because of socioeconomic factors, many patients with advanced non-small cell lung cancer (NSCLC) do not receive immunotherapy in the first-line setting. It is unknown if the combination of immunotherapy with chemotherapy can provide clinical benefits in immunotherapy-naive patients with disease progression after treatment with platinum-based chemotherapy.
Objective


To evaluate the safety and efficacy of the combination of pembrolizumab plus docetaxel in patients with previously treated advanced NSCLC following platinum-based chemotherapy regardless of EGFR variants or programmed cell death ligand 1 status.
Design, Setting, and Participants


The Pembrolizumab Plus Docetaxel for Advanced Non-Small Cell Lung Cancer (PROLUNG) trial randomized 78 patients with histologically confirmed advanced NSCLC in a 1:1 ratio to receive either pembrolizumab plus docetaxel or docetaxel alone from December 2016 through May 2019.
Interventions


The experimental arm received docetaxel on day 1 (75 mg/m2) plus pembrolizumab on day 8 (200 mg) every 3 weeks for up to 6 cycles followed by pembrolizumab maintenance until progression or unacceptable toxic effects. The control arm received docetaxel monotherapy.
Main Outcomes and Measures


The primary end point was overall response rate (ORR). Secondary end points included progression-free survival (PFS), overall survival, and safety.
Results


Among 78 recruited patients, 32 (41%) were men, 34 (44%) were never smokers, and 25 (32%) had an EGFR/ALK alteration. Forty patients were allocated to receive pembrolizumab plus docetaxel, and 38 were allocated to receive docetaxel. A statistically significant difference in ORR, assessed by an independent reviewer, was found in patients receiving pembrolizumab plus docetaxel vs patients receiving docetaxel (42.5% vs 15.8%; odds ratio, 3.94; 95% CI, 1.34-11.54; P = .01). Patients without EGFR variations had a considerable difference in ORR of 35.7% vs 12.0% (P = .06), whereas patients with EGFR variations had an ORR of 58.3% vs 23.1% (P = .14). Overall, PFS was longer in patients who received pembrolizumab plus docetaxel (9.5 months; 95% CI, 4.2-not reached) than in patients who received docetaxel (3.9 months; 95% CI, 3.2-5.7) (hazard ratio, 0.24; 95% CI, 0.13-0.46; P < .001). For patients without variations, PFS was 9.5 months (95% CI, 3.9-not reached) vs 4.1 months (95% CI, 3.5-5.3) (P < .001), whereas in patients with EGFR variations, PFS was 6.8 months (95% CI, 6.2-not reached) vs 3.5 months (95% CI, 2.3-6.2) (P = .04). In terms of safety, 23% (9 of 40) vs 5% (2 of 38) of patients experienced grade 1 to 2 pneumonitis in the pembrolizumab plus docetaxel and docetaxel arms, respectively (P = .03), while 28% (11 of 40) vs 3% (1 of 38) experienced any-grade hypothyroidism (P = .002). No new safety signals were identified.
Conclusions and Relevance


In this phase 2 study, the combination of pembrolizumab plus docetaxel was well tolerated and substantially improved ORR and PFS in patients with advanced NSCLC who had previous progression after platinum-based chemotherapy, including NSCLC with EGFR variations.
Trial Registration


ClinicalTrials.gov Identifier: NCT02574598.",2020,"For patients without variations, PFS was 9.5 months (95% CI, 3.9-not reached) vs 4.1 months (95% CI, 3.5-5.3) (","['patients with previously treated advanced NSCLC following platinum-based chemotherapy regardless of EGFR variants or programmed cell death ligand 1 status', 'Forty patients', 'patients with advanced NSCLC who had previous progression after platinum-based chemotherapy, including NSCLC with EGFR variations', 'for Advanced Non-Small Cell Lung Cancer (PROLUNG) trial randomized 78 patients with histologically confirmed advanced NSCLC in a 1:1 ratio to receive either', 'immunotherapy-naive patients with disease progression after treatment with platinum-based chemotherapy', '78 recruited patients, 32 (41%) were men, 34 (44%) were never smokers, and 25 (32%) had an EGFR/ALK alteration', 'Patients', 'patients with advanced non-small cell lung cancer (NSCLC', 'With Previously Treated Advanced Non-Small Cell Lung Cancer', 'alone from December 2016 through May 2019']","['immunotherapy with chemotherapy', 'Pembrolizumab Plus Docetaxel', 'docetaxel monotherapy', 'Pembrolizumab Plus Docetaxel vs Docetaxel Alone', 'pembrolizumab', 'pembrolizumab plus docetaxel or docetaxel', 'pembrolizumab plus docetaxel', 'pembrolizumab plus docetaxel and docetaxel', 'docetaxel']","['ORR', 'overall response rate (ORR', 'grade hypothyroidism', 'safety and efficacy', 'ORR and PFS', 'Overall, PFS', 'progression-free survival (PFS), overall survival, and safety', 'Efficacy and Safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0425293', 'cui_str': 'Never smoked tobacco'}, {'cui': 'C1663627', 'cui_str': 'ALK protein, human'}]","[{'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",78.0,0.210182,"For patients without variations, PFS was 9.5 months (95% CI, 3.9-not reached) vs 4.1 months (95% CI, 3.5-5.3) (","[{'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Arrieta', 'Affiliation': 'Thoracic Oncology Unit, Laboratory of Experimental Oncology, National Cancer Institute (INCan), Mexico City, Mexico.'}, {'ForeName': 'Feliciano', 'Initials': 'F', 'LastName': 'Barrón', 'Affiliation': 'Thoracic Oncology Unit, Laboratory of Experimental Oncology, National Cancer Institute (INCan), Mexico City, Mexico.'}, {'ForeName': 'Laura Alejandra', 'Initials': 'LA', 'LastName': 'Ramírez-Tirado', 'Affiliation': 'Thoracic Oncology Unit, Laboratory of Experimental Oncology, National Cancer Institute (INCan), Mexico City, Mexico.'}, {'ForeName': 'Zyanya Lucia', 'Initials': 'ZL', 'LastName': 'Zatarain-Barrón', 'Affiliation': 'Thoracic Oncology Unit, Laboratory of Experimental Oncology, National Cancer Institute (INCan), Mexico City, Mexico.'}, {'ForeName': 'Andrés F', 'Initials': 'AF', 'LastName': 'Cardona', 'Affiliation': 'Clinical and Translational Oncology Group, Clínica del Country, Bogotá, Colombia.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Díaz-García', 'Affiliation': 'Thoracic Oncology Unit, Laboratory of Experimental Oncology, National Cancer Institute (INCan), Mexico City, Mexico.'}, {'ForeName': 'Masao', 'Initials': 'M', 'LastName': 'Yamamoto Ramos', 'Affiliation': 'Thoracic Oncology Unit, Laboratory of Experimental Oncology, National Cancer Institute (INCan), Mexico City, Mexico.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Mota-Vega', 'Affiliation': 'Thoracic Oncology Unit, Laboratory of Experimental Oncology, National Cancer Institute (INCan), Mexico City, Mexico.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Carmona', 'Affiliation': 'Thoracic Oncology Unit, Laboratory of Experimental Oncology, National Cancer Institute (INCan), Mexico City, Mexico.'}, {'ForeName': 'Marco Polo', 'Initials': 'MP', 'LastName': 'Peralta Álvarez', 'Affiliation': 'Thoracic Oncology Unit, Laboratory of Experimental Oncology, National Cancer Institute (INCan), Mexico City, Mexico.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Bautista', 'Affiliation': 'Hospital de Oncología, Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, Mexico City, Mexico.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Aldaco', 'Affiliation': 'Servicio de Oncología Médica, Centro Médico Nacional 20 de Noviembre, Mexico City, Mexico.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Gerson', 'Affiliation': 'Departamento de Oncología, Centro Médico ABC, Mexico City, Mexico.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rolfo', 'Affiliation': 'Thoracic Medical Oncology and Early Clinical Trials, Marlene and Stewart Greenebaum Comprehensive Cancer Center, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Rosell', 'Affiliation': 'Molecular and Cellular Oncology Laboratory, Germans Trias i Pujol Research Institute and Hospital (IGTP), Barcelona, Spain.'}]",JAMA oncology,['10.1001/jamaoncol.2020.0409']
522,30969342,Effect of Developmentally Adapted Cognitive Processing Therapy for Youth With Symptoms of Posttraumatic Stress Disorder After Childhood Sexual and Physical Abuse: A Randomized Clinical Trial.,"Importance


Despite the high prevalence, evidence-based treatments for abuse-related posttraumatic stress disorder (PTSD) in adolescents have rarely been studied.
Objective


To examine whether developmentally adapted cognitive processing therapy (D-CPT) is more effective than a wait-list condition with treatment advice (WL/TA) among adolescents with PTSD related to childhood abuse.
Design, Setting, and Participants


This rater-blinded, multicenter, randomized clinical trial (stratified by center) enrolled treatment-seeking adolescents and young adults (aged 14-21 years) with childhood abuse-related PTSD at 3 university outpatient clinics in Germany from July 2013 to June 2015, with the last follow-up interview conducted by May 2016. Of 194 patients, 88 were eligible for randomization.
Interventions


Participants received D-CPT or WL/TA. Cognitive processing therapy was enhanced by a motivational and alliance-building phase, by including emotion regulation and consideration of typical developmental tasks, and by higher session frequency in the trauma-focused core CPT phase. In WL/TA, participants received treatment advice with respective recommendations of clinicians and were offered D-CPT after 7 months.
Main Outcomes and Measures


All outcomes were assessed before treatment (baseline), approximately 8 weeks after the start of treatment, after the end of treatment (posttreatment), and at the 3-month follow-up. The primary outcome, PTSD symptom severity, was assessed in clinical interview (Clinician-Administered PTSD Scale for Children and Adolescents for DSM-IV [CAPS-CA]). Secondary outcomes were self-reported PTSD severity, depression, borderline symptoms, behavior problems, and dissociation.
Results


The 88 participants (75 [85%] female) had a mean age of 18.1 years (95% CI, 17.6-18.6 years). In the intention-to-treat analysis, the 44 participants receiving D-CPT (39 [89%] female) demonstrated greater improvement than the 44 WL/TA participants (36 [82%] female) in terms of PTSD severity (mean CAPS-CA scores, 24.7 [95% CI, 16.6-32.7] vs 47.5 [95% CI, 37.9-57.1]; Hedges g = 0.90). This difference was maintained through the follow-up (mean CAPS-CA scores, 25.9 [95% CI, 16.2-35.6] vs 47.3 [95% CI, 37.8-56.8]; Hedges g = 0.80). Treatment success was greatest during the trauma-focused core phase. The D-CPT participants also showed greater and stable improvement in all secondary outcomes, with between-groups effect sizes ranging from 0.65 to 1.08 at the posttreatment assessment (eg, for borderline symptoms, 14.1 [95% CI, 8.0-20.2] vs 32.0 [95% CI, 23.8-40.2]; Hedges g = 0.91).
Conclusions and Relevance


Adolescents and young adults with abuse-related PTSD benefited more from D-CPT than from WL/TA. Treatment success was stable at the follow-up and generalized to borderline symptoms and other comorbidities.
Trial Registration


German Clinical Trials Register identifier: DRKS00004787.",2019,"This difference was maintained through the follow-up (mean CAPS-CA scores, 25.9 [95% CI, 16.2-35.6] vs 47.3 [95% CI, 37.8-56.8];","['88 participants (75 [85%] female) had a mean age of 18.1 years (95% CI, 17.6-18.6 years', 'adolescents with PTSD related to childhood abuse', 'After Childhood Sexual and Physical Abuse', 'center) enrolled treatment-seeking adolescents and young adults (aged 14-21 years) with childhood abuse-related PTSD at 3 university outpatient clinics in Germany from July 2013 to June 2015, with the last follow-up interview conducted by May 2016', '194 patients, 88 were eligible for randomization', 'Youth With Symptoms of Posttraumatic Stress Disorder']","['adapted cognitive processing therapy (D-CPT', 'Cognitive processing therapy', 'Developmentally Adapted Cognitive Processing Therapy', 'D-CPT or WL/TA']","['PTSD symptom severity', 'clinical interview (Clinician-Administered PTSD Scale for Children and Adolescents for DSM-IV [CAPS-CA', 'PTSD severity', 'self-reported PTSD severity, depression, borderline symptoms, behavior problems, and dissociation']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1546935', 'cui_str': 'Abuse (event)'}, {'cui': 'C1621955', 'cui_str': 'Physical Maltreatment'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521399', 'cui_str': 'LT'}]","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0199182', 'cui_str': 'Taking health history'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0222045'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0086168', 'cui_str': 'Dissociation'}]",,0.13041,"This difference was maintained through the follow-up (mean CAPS-CA scores, 25.9 [95% CI, 16.2-35.6] vs 47.3 [95% CI, 37.8-56.8];","[{'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Rosner', 'Affiliation': 'Department of Psychology, Catholic University Eichstätt-Ingolstadt, Eichstätt, Germany.'}, {'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Rimane', 'Affiliation': 'Department of Psychology, Catholic University Eichstätt-Ingolstadt, Eichstätt, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Frick', 'Affiliation': 'Hochschule Döpfer, University of Applied Sciences, Research Centre, University of Applied Sciences, Köln, Germany.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Gutermann', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Goethe University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hagl', 'Affiliation': 'Freelance researcher in München, Germany.'}, {'ForeName': 'Babette', 'Initials': 'B', 'LastName': 'Renneberg', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Freie Universitaet of Berlin, Berlin, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Schreiber', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Goethe University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Vogel', 'Affiliation': 'Department of Psychology, Catholic University Eichstätt-Ingolstadt, Eichstätt, Germany.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Steil', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Goethe University Frankfurt, Frankfurt am Main, Germany.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2018.4349']
523,32260047,Equine-Assisted Intervention to Improve Perceived Value of Everyday Occupations and Quality of Life in People with Lifelong Neurological Disorders: A Prospective Controlled Study.,"People with neurological disorders suffer from poor mobility, poor balance, fatigue, isolation and monotonous everyday activities. Studies show that equine-assisted interventions can improve their mobility and balance, but could these kinds of interventions also increase participants' activity repertoire and self-assessed health, and reduce their fatigue? The study was conducted as a prospective, controlled study with three cohorts followed for one year: intervention group ( n  = 14), control group Passive ( n  = 29), and control group Active ( n  = 147). Participants in the study were affected by neurological disease or injury that limited their opportunities for an active everyday life. The intervention group lacked regular activities outside the home before the intervention, which consisted of riding once a week, led by a certified therapist. Control group Passive lacked regular activities outside the home, while control group Active had several activities outside the home per week. Primary outcome measures were activity repertoire measured with Occupational Value Assessment questionnaire. Secondary outcome measures were global self-assessed health measured with EuroQol-VAS and fatigue measured with Shirom-Melamed Burnout Questionnaire. The intervention group's activity repertoire and self-assessed health increased significantly compared to both baseline and the control groups. Equine-assisted interventions could help to improve the perceived value of everyday occupations and quality of life, as well as break isolation and increase the activity repertoire of people with neurological disorders.",2020,The intervention group's activity repertoire and self-assessed health increased significantly compared to both baseline and the control groups.,"['people with neurological disorders', 'People with Lifelong Neurological Disorders', 'People with neurological disorders']","['Equine-assisted interventions', 'control group Passive', 'Equine-Assisted Intervention']","['activity repertoire measured with Occupational Value Assessment questionnaire', 'global self-assessed health measured with EuroQol-VAS and fatigue measured with Shirom-Melamed Burnout Questionnaire', 'Everyday Occupations and Quality of Life', 'activity repertoire and self-assessed health']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0027765', 'cui_str': 'Disorder of nervous system'}, {'cui': 'C4274169', 'cui_str': 'Lifelong'}]","[{'cui': 'C0019944', 'cui_str': 'Equus caballus'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0421487,The intervention group's activity repertoire and self-assessed health increased significantly compared to both baseline and the control groups.,"[{'ForeName': 'Anna María', 'Initials': 'AM', 'LastName': 'Pálsdóttir', 'Affiliation': 'The Department of Work Science, Business Economics and Environmental Psychology, Swedish University of Agricultural Sciences, P.O. Box 88, SE-230 53 Alnarp, Sweden.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Gudmundsson', 'Affiliation': 'Nature and Health, Region Dalarna, P.O. Box 712, SE-791 29 Falun, Sweden.'}, {'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Grahn', 'Affiliation': 'The Department of Work Science, Business Economics and Environmental Psychology, Swedish University of Agricultural Sciences, P.O. Box 88, SE-230 53 Alnarp, Sweden.'}]",International journal of environmental research and public health,['10.3390/ijerph17072431']
524,32260111,"An Enhanced Social Networking Intervention for Young People with Active Suicidal Ideation: Safety, Feasibility and Acceptability Outcomes.","Online social networking interventions have potential to support young people who experience suicidal thoughts by specifically addressing interpersonal risk factors for suicide, but may also pose a risk of harm. This uncontrolled, single-group pilot study aimed to evaluate the safety, feasibility, and acceptability of an enhanced online social networking intervention (""Affinity"") among a sample of young people who experienced active suicidal ideation, and to explore potential changes in clinical outcomes and the therapeutic targets of the intervention. Twenty young people with current or recent suicidal ideation who were receiving treatment for depression at a tertiary-level mental health service were given access to Affinity for two months. Participants were assessed at baseline and 8-week follow-up; 90 percent reported clinical suicidal ideation at baseline. A priori criteria related to feasibility, safety and acceptability were satisfied. In terms of potential clinical effects, significant and reliable pre-post improvements were found on self-report outcomes including suicidal ideation. This study provides initial world-first evidence to support the use of an online intervention incorporating social networking as an adjunct to treatment for young people who experience suicidal ideation. The effectiveness of Affinity needs to be evaluated in a randomised controlled trial.",2020,"Online social networking interventions have potential to support young people who experience suicidal thoughts by specifically addressing interpersonal risk factors for suicide, but may also pose a risk of harm.","['Young People with Active Suicidal Ideation', 'Twenty young people with current or recent suicidal ideation who were receiving treatment for depression at a tertiary-level mental health service', 'young people who experienced active suicidal ideation', 'young people who experience suicidal ideation']","['Social Networking Intervention', 'Online social networking interventions', 'enhanced online social networking intervention (""Affinity', 'online intervention incorporating social networking']","['safety, feasibility, and acceptability', 'clinical suicidal ideation', 'suicidal ideation']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0749133', 'cui_str': 'Active suicidal ideation'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C3179002', 'cui_str': 'Social Networking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4704733', 'cui_str': 'Online Social Networking'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}]",20.0,0.0821077,"Online social networking interventions have potential to support young people who experience suicidal thoughts by specifically addressing interpersonal risk factors for suicide, but may also pose a risk of harm.","[{'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Bailey', 'Affiliation': 'Orygen, Parkville, Victoria 3052, Australia.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Alvarez-Jimenez', 'Affiliation': 'Orygen, Parkville, Victoria 3052, Australia.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Robinson', 'Affiliation': 'Orygen, Parkville, Victoria 3052, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': ""D'Alfonso"", 'Affiliation': 'Orygen, Parkville, Victoria 3052, Australia.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Nedeljkovic', 'Affiliation': 'Swinburne University of Technology, Hawthorn, Victoria 3122, Australia.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Davey', 'Affiliation': 'Orygen, Parkville, Victoria 3052, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bendall', 'Affiliation': 'Orygen, Parkville, Victoria 3052, Australia.'}, {'ForeName': 'Tamsyn', 'Initials': 'T', 'LastName': 'Gilbertson', 'Affiliation': 'Orygen, Parkville, Victoria 3052, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Phillips', 'Affiliation': 'Orygen, Parkville, Victoria 3052, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Bloom', 'Affiliation': 'Orygen, Parkville, Victoria 3052, Australia.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Nicholls', 'Affiliation': 'Orygen, Parkville, Victoria 3052, Australia.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Garland', 'Affiliation': 'Orygen, Parkville, Victoria 3052, Australia.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Cagliarini', 'Affiliation': 'Orygen, Parkville, Victoria 3052, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Phelan', 'Affiliation': 'Orygen, Parkville, Victoria 3052, Australia.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'McKechnie', 'Affiliation': 'Orygen, Parkville, Victoria 3052, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Mitchell', 'Affiliation': 'Orygen, Parkville, Victoria 3052, Australia.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Cooke', 'Affiliation': 'Orygen, Parkville, Victoria 3052, Australia.'}, {'ForeName': 'Simon M', 'Initials': 'SM', 'LastName': 'Rice', 'Affiliation': 'Orygen, Parkville, Victoria 3052, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17072435']
525,31860104,Effect of a Motivational Interviewing-Based Intervention on Initiation of Mental Health Treatment and Mental Health After an Emergency Department Visit Among Suicidal Adolescents: A Randomized Clinical Trial.,"Importance


Emergency department (ED) visits present opportunities to identify and refer suicidal youth for outpatient mental health care, although this practice is not routine.
Objective


To examine whether a motivational interviewing-based intervention increases linkage of adolescents to outpatient mental health services and reduces depression symptoms and suicidal ideation in adolescents seeking emergency care for non-mental health-related concerns who screen positive for suicide risk.
Design, Setting, and Participants


In this randomized clinical trial, adolescents aged 12 to 17 years who screened positive on the Ask Suicide Screening Questions (ASQ) during a nonpsychiatric ED visit at 2 academic pediatric EDs in Ohio were recruited from April 2013 to July 2015. Intention-to-treat analyses were performed from September 2018 to October 2019.
Interventions


The Suicidal Teens Accessing Treatment After an Emergency Department Visit (STAT-ED) intervention included motivational interviewing to target family engagement, problem solving, referral assistance, and limited case management. The enhanced usual care (EUC) intervention consisted of brief mental health care consultation and referral.
Main Outcomes and Measures


Primary outcomes were mental health treatment initiation and attendance within 2 months of ED discharge and suicidal ideation (assessed by the Suicidal Ideation Questionnaire JR) and depression symptoms (assessed by the Center for Epidemiologic Studies-Depression scale) at 2 and 6 months. Exploratory outcomes included treatment initiation and attendance and suicide attempts at 6 months.
Results


A total of 168 participants were randomized and 159 included in the intention-to-treat analyses (mean [SD] age, 15.0 [1.5] years; 126 [79.2%] female; and 80 [50.3%] white). Seventy-nine participants were randomized to receive the STAT-ED intervention and 80 to receive EUC. At 2 months, youth in the STAT-ED group had similar rates of mental health treatment initiation compared with youth in the EUC group as assessed by parent report (29 [50.9%] vs 22 [34.9%]; adjusted odds ratio [OR], 2.08; 95% CI, 0.97-4.45) and administrative data from mental health care agencies (19 [29.7%] vs 11 [19.3%]; adjusted OR, 1.77; 95% CI, 0.76-4.15). At 2 months, youth in the STAT-ED group and the EUC group had similar rates of treatment attendance (1 appointment: 6 [9.7%] vs 2 [3.6%]; adjusted OR, 2.97; 95% CI, 0.56-15.73; ≥2 appointments: 10 [16.1%] vs 7 [12.7%]; adjusted OR, 1.43; 95% CI, 0.50-4.11). There were no significant group × time differences in suicidal ideation (F = 0.28; P = .72) and depression symptoms (F = 0.49; P = .60) during the 6-month follow-up period. In exploratory analyses, at 6 months, STAT-ED participants had significantly higher rates of agency-reported mental health treatment initiation (adjusted OR, 2.48; 95% CI, 1.16-5.28) and more completed appointments (t99.7 = 2.58; P = .01).
Conclusions and Relevance


This study's findings indicate that no differences were found on any primary outcome by study condition. However, STAT-ED was more efficacious than EUC at increasing mental health treatment initiation and attendance at 6 months.
Trial Registration


ClinicalTrials.gov identifier: NCT01779414.",2019,There were no significant group × time differences in suicidal ideation (F = 0.28; P = .72) and depression symptoms (F = 0.49; P = .60) during the 6-month follow-up period.,"['adolescents seeking emergency care for non-mental health-related concerns who screen positive for suicide risk', 'adolescents to outpatient mental health services', 'A total of 168 participants were randomized and 159 included in the intention-to-treat analyses (mean [SD] age, 15.0 [1.5] years; 126 [79.2%] female; and 80 [50.3%] white', 'adolescents aged 12 to 17 years who screened positive on the Ask Suicide Screening Questions (ASQ) during a nonpsychiatric ED visit at 2 academic pediatric EDs in Ohio were recruited from April 2013 to July 2015', 'Suicidal Teens Accessing Treatment', 'Seventy-nine participants', 'Suicidal Adolescents']","['Emergency Department Visit (STAT-ED) intervention included motivational interviewing to target family engagement, problem solving, referral assistance, and limited case management', 'motivational interviewing-based intervention', 'EUC', 'STAT-ED intervention and 80 to receive EUC', 'Motivational Interviewing-Based Intervention', 'enhanced usual care (EUC) intervention consisted of brief mental health care consultation and referral']","['rates of treatment attendance', 'mental health treatment initiation and attendance within 2 months of ED discharge and suicidal ideation (assessed by the Suicidal Ideation Questionnaire JR) and depression symptoms (assessed by the Center for Epidemiologic Studies-Depression scale', 'Initiation of Mental Health Treatment and Mental Health', 'rates of mental health treatment initiation', 'rates of agency-reported mental health treatment initiation', 'suicidal ideation', 'treatment initiation and attendance and suicide attempts at 6 months', 'depression symptoms']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1527398', 'cui_str': 'Emergency Care'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0563664', 'cui_str': 'Suicide risk'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0025355', 'cui_str': 'Mental Hygiene Services'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0028905', 'cui_str': 'Ohio'}, {'cui': 'C0438696', 'cui_str': 'Suicidal (finding)'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0205548', 'cui_str': 'Stat (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0085971', 'cui_str': 'Case Management'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0034928', 'cui_str': 'Referral and Consultation'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0184647', 'cui_str': 'Mental health treatment'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt (event)'}]",79.0,0.222037,There were no significant group × time differences in suicidal ideation (F = 0.28; P = .72) and depression symptoms (F = 0.49; P = .60) during the 6-month follow-up period.,"[{'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Grupp-Phelan', 'Affiliation': ""Division of Pediatric Emergency Medicine, UCSF (University of California, San Francisco) Benioff Children's Hospitals, San Francisco, California.""}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Stevens', 'Affiliation': ""Department of Pediatrics, The Abigail Wexner Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Boyd', 'Affiliation': ""Division of Emergency Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Cohen', 'Affiliation': ""Division of Emergency Medicine, Nationwide Children's Hospital, The Ohio State University, Columbus.""}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Ammerman', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio.""}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Liddy-Hicks', 'Affiliation': ""Division of Emergency Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Kendra', 'Initials': 'K', 'LastName': 'Heck', 'Affiliation': ""Department of Pediatrics, The Abigail Wexner Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Marcus', 'Affiliation': 'University of Pennsylvania School of Social Policy and Practice, Philadelphia.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Stone', 'Affiliation': ""Division of Emergency Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'John V', 'Initials': 'JV', 'LastName': 'Campo', 'Affiliation': 'Department of Behavioral Medicine and Psychiatry, West Virginia University and the Rockefeller Neuroscience Institute, Morgantown.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Bridge', 'Affiliation': ""Department of Pediatrics, The Abigail Wexner Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}]",JAMA network open,['10.1001/jamanetworkopen.2019.17941']
526,32267573,"Impacts of CYP2C19 genetic polymorphisms on bioavailability and effect on platelet adhesion of vicagrel, a novel thienopyridine P2Y 12  inhibitor.","AIMS


We investigated the impacts of CYP2C19 polymorphisms on pharmacokinetics and pharmacodynamics of vicagrel in healthy Chinese subjects.
METHODS


CYP2C19 extensive metabolizers (EMs), intermediate metabolizers (IMs) and poor metabolizers (PMs; 16 subjects/group) participated in a randomized, open-label, 2-period cross-over study. Each study period lasted 7 days, with a loading dose of 24 mg of vicagrel or 300 mg of clopidogrel on day 1, and maintenance doses of 6 mg of vicagrel or 75 mg of clopidogrel daily from day 2 to day 7. The pharmacokinetics and pharmacodynamics were assessed on day 1 and day 7.
RESULTS


After a loading dose, the AUC 0-t  of the active metabolite H4 by vicagrel was slightly lower in IMs and PMs (decreased by 21 and 27%, respectively) compared to EMs. Similar results were found after maintenance doses. In EMs, the AUC 0-t  of H4 by vicagrel was somewhat higher than clopidogrel after the loading dose, and comparable with clopidogrel (90% confidence interval 0.94, 1.21) after the maintenance doses. However, it was much higher than clopidogrel in PMs, with a 1.28-fold (loading dose) and a 73% (maintenance doses) increases compared to clopidogrel (P < 0.001). Consequently, the inhibition of platelet aggregation by vicagrel was greater than clopidogrel after both loading dose (28.2 vs 12.4% at 4 hours, P < 0.01) and maintenance doses (42.8 vs 24.6% at 4 hours, P < 0.001) in PMs.
CONCLUSIONS


CYP2C19 polymorphisms have less impact on vicagrel as compared to clopidogrel. Drug exposure and response to vicagrel in PMs were even higher than to clopidogrel in IMs.",2020,"After a loading dose, the AUC 0-t  of the active metabolite H4 by vicagrel was slightly lower in IMs and PMs (decreased by 21% and 27%, respectively) compared to EMs.","['CYP2C19 extensive metabolizers (EMs), intermediate metabolizers (IMs), and poor metabolizers (PMs) (18 subjects/group', 'healthy Chinese subjects']","['vicagrel or 300 mg of clopidogrel', 'vicagrel or 75 mg of clopidogrel']","['IMs and PMs', 'pharmacokinetics and pharmacodynamics', 'IPA by vicagrel', 'AUC 0-t  of H4 by vicagrel']","[{'cui': 'C0960580', 'cui_str': 'CYP2C19 protein, human'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C3501000', 'cui_str': 'methyl 2-(2-acetoxy-6,7-dihydrothieno(3,2-c)pyridin-5(4H)-yl)-2-(2-chlorophenyl)acetate'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0033046', 'cui_str': 'Premenstrual syndrome'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C3501000', 'cui_str': 'methyl 2-(2-acetoxy-6,7-dihydrothieno(3,2-c)pyridin-5(4H)-yl)-2-(2-chlorophenyl)acetate'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",,0.0242884,"After a loading dose, the AUC 0-t  of the active metabolite H4 by vicagrel was slightly lower in IMs and PMs (decreased by 21% and 27%, respectively) compared to EMs.","[{'ForeName': 'Yifan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, China.'}, {'ForeName': 'Xiaoxue', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Phase I Clinical Trial Unit, First Hospital, Jilin University, Jilin, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhan', 'Affiliation': 'State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, China.'}, {'ForeName': 'Xiaojiao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Phase I Clinical Trial Unit, First Hospital, Jilin University, Jilin, China.'}, {'ForeName': 'Cai', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, China.'}, {'ForeName': 'Yunting', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Phase I Clinical Trial Unit, First Hospital, Jilin University, Jilin, China.'}, {'ForeName': 'Haijing', 'Initials': 'H', 'LastName': 'Wei', 'Affiliation': 'Phase I Clinical Trial Unit, First Hospital, Jilin University, Jilin, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': 'State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, China.'}, {'ForeName': 'Hongbin', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'State Key Laboratory of Natural Medicines and Center of Drug Discovery, College of Pharmacy, China Pharmaceutical University, Nanjing, China.'}, {'ForeName': 'Yongqiang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Jiangsu Vcare PharmaTech Co., Ltd., Nanjing, China.'}, {'ForeName': 'Xiaojuan', 'Initials': 'X', 'LastName': 'Lai', 'Affiliation': 'Jiangsu Vcare PharmaTech Co., Ltd., Nanjing, China.'}, {'ForeName': 'Yanchun', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'Jiangsu Vcare PharmaTech Co., Ltd., Nanjing, China.'}, {'ForeName': 'Xuefang', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Jiangsu Vcare PharmaTech Co., Ltd., Nanjing, China.'}, {'ForeName': 'Yongguo', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Hua Medicine Ltd., Shanghai, China.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Phase I Clinical Trial Unit, First Hospital, Jilin University, Jilin, China.'}, {'ForeName': 'Dafang', 'Initials': 'D', 'LastName': 'Zhong', 'Affiliation': 'State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, China.'}]",British journal of clinical pharmacology,['10.1111/bcp.14296']
527,30816331,"Treatment of higher risk acute lymphoblastic leukemia in young people (CCG-1961), long-term follow-up: a report from the Children's Oncology Group.","Children's Cancer Group CCG-1882 improved outcome for 1-21-year old with high risk acute lymphoblastic leukemia and Induction Day 8 marrow blasts ≥25% (slow early responders, SER) with longer and stronger post induction intensification (PII). This CCG-1961 explored alternative PII strategies. We report 10-year follow-up for patients with rapid early response (RER) and for the first time details our experience for SER patients. A total of 2057 patients were enrolled, and 1299 RER patients were randomized to 1 of 4 PII regimens: standard vs. augmented intensity and standard vs. increased length. At the end of interim maintenance, 447 SER patients were randomized to idarubicin/cyclophosphamide or weekly doxorubicin in the delayed intensification phases. The 10-year EFS for RER were 79.4 ± 2.4% and 70.9 ± 2.6% (hazard ratio = 0.65, 95% CI 0.52-0.82, p < 0.001) for augmented and standard strength PII; the 10-year OS rates were 87.2 ± 2.0% and 81.0 ± 2.2% (hazard ratio = 0.64, 95% CI 0.48-0.86, p = 0.003). Outcomes remain similar for standard and longer PII, and for SER patients assigned to idarubicin/cyclophosphamide and weekly doxorubicin. The EFS and OS advantage of augmented PII is sustained at 10 years for RER patients. Longer PII for RER patients and sequential idarubicin/cyclophosphamide for SER patients offered no advantage. CCG-1961 is the platform for subsequent COG studies.",2019,"Outcomes remain similar for standard and longer PII, and for SER patients assigned to idarubicin/cyclophosphamide and weekly doxorubicin.","['patients with rapid early response (RER) and for the first time\xa0details our experience for SER patients', '447 SER patients', '2057 patients were enrolled, and 1299 RER patients']","['idarubicin/cyclophosphamide and weekly doxorubicin', 'idarubicin/cyclophosphamide or weekly doxorubicin', 'idarubicin/cyclophosphamide', 'CCG-1961']","['10-year OS rates', '10-year EFS for RER']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}]","[{'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",2057.0,0.0559644,"Outcomes remain similar for standard and longer PII, and for SER patients assigned to idarubicin/cyclophosphamide and weekly doxorubicin.","[{'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Steinherz', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA. steinhep@mskcc.org.'}, {'ForeName': 'Nita L', 'Initials': 'NL', 'LastName': 'Seibel', 'Affiliation': ""Children's National Health System, George Washington University School of Medicine and Health Sciences, Washington, DC, USA.""}, {'ForeName': 'Harland', 'Initials': 'H', 'LastName': 'Sather', 'Affiliation': ""Children's Oncology Group, Los Angeles, CA, USA.""}, {'ForeName': 'Lingyun', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Xinxin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""Children's Oncology Group, Los Angeles, CA, USA.""}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Devidas', 'Affiliation': 'Department of Biostatistics, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Gaynon', 'Affiliation': ""Children's Hospital of Los Angeles, Los Angeles, CA, USA.""}]",Leukemia,['10.1038/s41375-019-0422-z']
528,32260239,"The Effect of a Mindfulness-Based Intervention on Attention, Self-Control, and Aggressiveness in Primary School Pupils.","The objective of this study was to examine the effect of  Mindkeys Training , a mindfulness-based educational intervention, on attention, self-control, and aggressiveness in third-year primary school pupils. In order to achieve this aim, a switching replications design was used. Two groups of third year primary students (n GE1  = 40; n GE2  = 33), aged between 7 and 10 years old (M = 8.08; DT = 0.49), had the intervention at different time points, such that while one served as the experimental group, the other served as the control group. Longitudinal differences were examined in both groups, and cross-sectional differences were examined between the two groups at three time points; at the start of the study, and following the intervention with each group. To that end, measurements of problems of attention, deficits of self-control, and aggressiveness for students were obtained via a teacher rating scale. The intervention program demonstrated a positive effect on the reduction of pupils' attention problems, deficits of self-control, and aggressiveness. The effects were greater on the cognitive variables that the intervention worked on directly (attention and self-control). Attention was the variable on which the intervention exhibited the longest term effects.",2020,"The intervention program demonstrated a positive effect on the reduction of pupils' attention problems, deficits of self-control, and aggressiveness.","['third-year primary school pupils', 'Primary School Pupils', 'Two groups of third year primary students (n GE1  = 40; n GE2  = 33), aged between 7 and 10 years old (M = 8.08; DT = 0.49), had the intervention at different time points, such that while one served as the experimental group, the other served as the control group']","['Mindkeys Training , a mindfulness-based educational intervention', 'Mindfulness-Based Intervention']","[""reduction of pupils' attention problems, deficits of self-control, and aggressiveness"", 'problems of attention, deficits of self-control, and aggressiveness']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}]",,0.011466,"The intervention program demonstrated a positive effect on the reduction of pupils' attention problems, deficits of self-control, and aggressiveness.","[{'ForeName': 'Zara', 'Initials': 'Z', 'LastName': 'Suárez-García', 'Affiliation': 'Faculty of Psychology, University of Oviedo, Plaza de Feijoo, s/n, 33003 Oviedo, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Álvarez-García', 'Affiliation': 'Faculty of Psychology, University of Oviedo, Plaza de Feijoo, s/n, 33003 Oviedo, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'García-Redondo', 'Affiliation': 'Faculty of Psychology, University of Oviedo, Plaza de Feijoo, s/n, 33003 Oviedo, Spain.'}, {'ForeName': 'Celestino', 'Initials': 'C', 'LastName': 'Rodríguez', 'Affiliation': 'Faculty of Psychology, University of Oviedo, Plaza de Feijoo, s/n, 33003 Oviedo, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17072447']
529,32260313,Effects of Monopolar Dielectric Radiofrequency Signals on the Symptoms of Fibromyalgia: A Single-Blind Randomized Controlled Trial.,"Monopolar dielectric radiofrequency (MDR) is a non-invasive treatment for pain based on the local application of electromagnetic signals. The study's goal was to analyze the effects of MDR on the symptoms of fibromyalgia. For this aim, a randomized controlled trial was conducted on 66 female participants (aged 47 17.7) diagnosed with fibromyalgia. Participants were randomly allocated to either an experimental group ( n  = 23), which received eight 20-minute sessions of MDR; a sham group, which received the same number of sessions of a sham MDR therapy ( n  = 22); or a control group ( n  = 21), which received usual care. The outcome variables included pain measured by the visual analogue scale (VAS), score on the hospital anxiety and depression scale (HADS) and quality of life measured by the combined index of fibromyalgia severity (ICAF). A large effect size was observed for the local pain (R 2  = 0.46), total ICAF (R 2  = 0.42) and ICAF physical factor scores (R 2  = 0.38). Significant mean differences were found for the local pain ( p  = 0.025) and ICAF physical factor ( p  = 0.031) scores of the experimental group in comparison with the sham group. No statistically significant differences between groups were found in HADS. In conclusion, MDR is more effective than either sham treatment or usual care in the short-term improvement of pain and the physical wellbeing of participants with fibromyalgia.",2020,Significant mean differences were found for the local pain ( p  = 0.025) and ICAF physical factor ( p  = 0.031) scores of the experimental group in comparison with the sham group.,"['66 female participants (aged 47 17.7) diagnosed with fibromyalgia', 'participants with fibromyalgia', 'Fibromyalgia']","['Monopolar Dielectric Radiofrequency Signals', 'sham MDR therapy', 'MDR', 'Monopolar dielectric radiofrequency (MDR', 'control group ( n  = 21), which received usual care']","['ICAF physical factor', 'ICAF physical factor scores', 'total ICAF', 'local pain', 'pain measured by the visual analogue scale (VAS), score on the hospital anxiety and depression scale (HADS) and quality of life measured by the combined index of fibromyalgia severity (ICAF', 'pain and the physical wellbeing', 'HADS']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517598', 'cui_str': '17.7'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}]","[{'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0242640', 'cui_str': 'Multiple-drug resistance'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0048008', 'cui_str': ""4-amino-4'-hydroxylaminodiphenylsulfone""}]",66.0,0.106082,Significant mean differences were found for the local pain ( p  = 0.025) and ICAF physical factor ( p  = 0.031) scores of the experimental group in comparison with the sham group.,"[{'ForeName': 'Alfonso Javier', 'Initials': 'AJ', 'LastName': 'Ibáñez-Vera', 'Affiliation': 'Department of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}, {'ForeName': 'Jerónimo Carmelo', 'Initials': 'JC', 'LastName': 'García-Romero', 'Affiliation': 'Department of Human Physiology, Human Histology, Pathological Anatomy and Physical Education and Sports, University of Málaga, 29071 Andalucía TECH, Spain.'}, {'ForeName': 'José Ramón', 'Initials': 'JR', 'LastName': 'Alvero-Cruz', 'Affiliation': 'Department of Human Physiology, Human Histology, Pathological Anatomy and Physical Education and Sports, University of Málaga, 29071 Andalucía TECH, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Lomas-Vega', 'Affiliation': 'Department of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17072465']
530,32260466,"Effect of  Schisandra Chinensis  Extract Supplementation on Quadriceps Muscle Strength and Fatigue in Adult Women: A Randomized, Double-Blind, Placebo-Controlled Trial.","The fruit of  Schisandra chinensis  (SC) is a well-known traditional herb used for pharmacological purposes in Asian countries (e.g., Korea, China, and Japan). In animal studies, SC extract supplementation had beneficial effects on muscle strength and lactate level. However, the effect of SC extract supplementation on skeletal muscle strength and lactate at rest in humans remains unclear. The purpose of this study was to evaluate the effect of SC extract supplementation on quadriceps muscle strength (QMS) and lactate at rest in adult women. Forty five healthy post-menopausal middle-aged women (61.9 ± 8.4 years) were randomly divided into the SC ( n  = 24) or the placebo group ( n  = 21). The SC group consumed 1000 mg of SC extract per day, whereas the placebo group consumed 1000 mg of starch per day for 12 weeks. The difference in muscle mass, physical function, and biomarkers and the relative changes between baseline and 12 weeks were evaluated. We used two-factor repeated measures analysis of variance (ANOVA) to determine interaction (group × time) effects for variables. Statistical significance was accepted at  p  < 0.05. In ANOVA results, QMS ( p  = 0.001) and lactate level ( p  = 0.038) showed significant interactions. With paired t-tests, QMS was significantly increased ( p  < 0.001) and lactate level at rest was significantly decreased ( p  < 0.05) after 12 weeks in the SC group. However, no interactions were found between the other variables. Supplementation of SC extract may help to improve QMS as well as decrease lactate level at rest in adult women. We believe that SC extract is a health supplement that can support healthy life in this population.",2020,"In ANOVA results, QMS ( p  = 0.001) and lactate level ( p  = 0.038) showed significant interactions.","['Adult Women', 'adult women', 'Forty five healthy post-menopausal middle-aged women (61.9 ± 8.4 years']","['placebo', 'SC', 'SC extract supplementation', 'Schisandra Chinensis  Extract Supplementation', 'Placebo']","['muscle mass, physical function, and biomarkers and the relative changes', 'quadriceps muscle strength (QMS) and lactate at rest', 'lactate level at rest', 'skeletal muscle strength and lactate', 'Quadriceps Muscle Strength and Fatigue', 'lactate level', 'muscle strength and lactate level', 'QMS']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0696946', 'cui_str': 'Wu wei zi'}]","[{'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0224440', 'cui_str': 'Structure of quadriceps femoris muscle'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",,0.33307,"In ANOVA results, QMS ( p  = 0.001) and lactate level ( p  = 0.038) showed significant interactions.","[{'ForeName': 'Jinkee', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Sport Rehabilitation, Dong Ju College, Busan 49318, Korea.'}, {'ForeName': 'Seoungho', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': 'Department of Family Medicine, College of Medicine, Dong-A University, Busan 49201, Korea.'}, {'ForeName': 'Hyuntae', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Department of Health Care and Science, Dong-A University, Busan 49315, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17072475']
531,31037971,"Paper and electronic versions of HM-PRO, a novel patient-reported outcome measure for hematology: an equivalence study.","Aim:  To determine measurement equivalence of paper and electronic application of the hematological malignancy-patient-reported outcome (HM-PRO), a specific measure for the evaluation of patient-reported outcomes in HMs.  Patients & methods:  Following International Society of Pharmacoeconomics and Outcomes Research ePRO Good Research Practice Task Force guidelines, a total of 193 adult patients with different HMs were recruited into a multicenter prospective study. The paper and the electronic version of the instrument were completed in the outpatient clinics in a randomized crossover design with a 30 min time interval to minimize the learning effect. Those who completed the paper version first, completed the electronic version after 30 min and vice versa. Instrument version and order effects were tested on total score of the two parts of the HM-PRO (Part A: quality of life and Part B: signs & symptoms) in a two-way ANOVA with patients as random effects. Intraclass correlation coefficients (95% CI) and Spearman's rank correlation coefficients were used to evaluate test-retest reliability and reproducibility. The effects of instrument version and order were tested on total score of the two parts of HM-PRO.  Results:  The questionnaire version and administration order effects were not significant at the 5% level. There were no interactions found between these two factors for HM-PRO (Part A [quality of life]; p = 0.95); and (part B [signs and symptoms]; p = 0.72]. Spearman's rank correlation coefficients were greater than 0.9, and intraclass correlation coefficients ranged from 0.94 to 0.98; furthermore, the scores were not statistically different between the two versions, showing acceptable reliability indexes. Noteworthy, the difference between the completion time for both paper (mean = 6:38 min) and electronic version (mean = 7:29 min) was not statistically significant (n = 100; p = 0.11). Patients did not report any difficulty in completing the electronic version during cognitive interviews and were able to understand and respond spontaneously.  Conclusion:  Measurement equivalence has been demonstrated for the paper and electronic application of the HM-PRO.",2019,There were no interactions found between these two factors for HM-PRO,['193 adult patients with different HMs'],['HM-PRO'],"['quality of life and Part B: signs & symptoms', 'electronic version', 'HM-PRO']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0034380'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}]",193.0,0.025189,There were no interactions found between these two factors for HM-PRO,"[{'ForeName': 'Pushpendra', 'Initials': 'P', 'LastName': 'Goswami', 'Affiliation': 'School of Life & Medical Sciences, University of Hertfordshire, Hatfield, UK.'}, {'ForeName': 'Esther N', 'Initials': 'EN', 'LastName': 'Oliva', 'Affiliation': 'Haematology Unit, Grande Ospedale Metropolitano, Reggio Calabria, Italy.'}, {'ForeName': 'Tatyana', 'Initials': 'T', 'LastName': 'Ionova', 'Affiliation': 'St Petersburg State University Medical Centre & Multinational Centre for Quality of Life Research, St Petersburg, Russia.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Else', 'Affiliation': 'Patient Research Partner, Milton Keynes, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Kell', 'Affiliation': 'Haematology, Cardiff & Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'Adele K', 'Initials': 'AK', 'LastName': 'Fielding', 'Affiliation': 'Haematology, University College London Cancer Institute, London, UK.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Jennings', 'Affiliation': 'Haematology, Royal Surrey County Hospital NHS Foundation Trust, Guildford, Surrey, UK.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Karakantza', 'Affiliation': 'Haematology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Saad', 'Initials': 'S', 'LastName': 'Al-Ismail', 'Affiliation': 'Haematology, Singleton Hospital, ABM University Health Board, Swansea, UK.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Lyness', 'Affiliation': 'Haematology, Singleton Hospital, ABM University Health Board, Swansea, UK.'}, {'ForeName': 'Graham P', 'Initials': 'GP', 'LastName': 'Collins', 'Affiliation': 'Haematology, Oxford University Hospitals NHS Trust, Oxford, UK.'}, {'ForeName': 'Stewart', 'Initials': 'S', 'LastName': 'McConnell', 'Affiliation': 'Haematology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Langton', 'Affiliation': 'Haematology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Magda Jabbar', 'Initials': 'MJ', 'LastName': 'Al-Obaidi', 'Affiliation': 'Haematology, West Middlesex University Hospital, Isleworth, UK.'}, {'ForeName': 'Metod', 'Initials': 'M', 'LastName': 'Oblak', 'Affiliation': 'Haematology, West Middlesex University Hospital, Isleworth, UK.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Salek', 'Affiliation': 'School of Life & Medical Sciences, University of Hertfordshire, Hatfield, UK.'}]",Journal of comparative effectiveness research,['10.2217/cer-2018-0108']
532,30958508,Recurrent Stroke With Rivaroxaban Compared With Aspirin According to Predictors of Atrial Fibrillation: Secondary Analysis of the NAVIGATE ESUS Randomized Clinical Trial.,"Importance


The NAVIGATE ESUS randomized clinical trial found that 15 mg of rivaroxaban per day does not reduce stroke compared with aspirin in patients with embolic stroke of undetermined source (ESUS); however, it substantially reduces stroke risk in patients with atrial fibrillation (AF).
Objective


To analyze whether rivaroxaban is associated with a reduction of recurrent stroke among patients with ESUS who have an increased risk of AF.
Design, Setting, and Participants


Participants were stratified by predictors of AF, including left atrial diameter, frequency of premature atrial contractions, and HAVOC score, a validated scheme using clinical features. Treatment interactions with these predictors were assessed. Participants were enrolled between December 2014 and September 2017, and analysis began March 2018.
Intervention


Rivaroxaban treatment vs aspirin.
Main Outcomes and Measures


Risk of ischemic stroke.
Results


Among 7112 patients with a mean (SD) age of 67 (9.8) years, the mean (SD) HAVOC score was 2.6 (1.8), the mean (SD) left atrial diameter was 3.8 (1.4) cm (n = 4022), and the median (interquartile range) daily frequency of premature atrial contractions was 48 (13-222). Detection of AF during follow-up increased for each tertile of HAVOC score: 2.3% (score, 0-2), 3.0% (score, 3), and 5.8% (score, >3); however, neither tertiles of the HAVOC score nor premature atrial contractions frequency impacted the association of rivaroxaban with recurrent ischemic stroke (P for interaction = .67 and .96, respectively). Atrial fibrillation annual incidence increased for each tertile of left atrial diameter (2.0%, 3.6%, and 5.2%) and for each tertile of premature atrial contractions frequency (1.3%, 2.9%, and 7.0%). Among the predefined subgroup of patients with a left atrial diameter of more than 4.6 cm (9% of overall population), the risk of ischemic stroke was lower among the rivaroxaban group (1.7% per year) compared with the aspirin group (6.5% per year) (hazard ratio, 0.26; 95% CI, 0.07-0.94; P for interaction = .02).
Conclusions and Relevance


The HAVOC score, left atrial diameter, and premature atrial contraction frequency predicted subsequent clinical AF. Rivaroxaban was associated with a reduced risk of recurrent stroke among patients with ESUS and moderate or severe left atrial enlargement; however, this needs to be independently confirmed before influencing clinical practice.",2019,"Rivaroxaban was associated with a reduced risk of recurrent stroke among patients with ESUS and moderate or severe left atrial enlargement; however, this needs to be independently confirmed before influencing clinical practice.","['patients with atrial fibrillation (AF', 'patients with ESUS and moderate or severe left atrial enlargement', '7112 patients with a mean (SD) age of 67 (9.8) years, the mean (SD) HAVOC score was 2.6\u2009(1.8), the mean (SD) left atrial diameter was 3.8\u2009(1.4) cm (n\u2009=\u20094022), and the median (interquartile range) daily frequency of premature atrial contractions was 48 (13-222', 'patients with ESUS who have an increased risk of AF.\nDesign, Setting, and Participants\n\n\nParticipants', 'patients with embolic stroke of undetermined source (ESUS', 'Participants were enrolled between December 2014 and September 2017, and analysis began March 2018']","['aspirin', 'Rivaroxaban', 'Aspirin', 'rivaroxaban', 'Rivaroxaban treatment vs aspirin']","['Detection of AF', 'recurrent stroke', 'Atrial fibrillation annual incidence', 'premature atrial contractions frequency', 'risk of ischemic stroke', 'Measures\n\n\nRisk of ischemic stroke', 'HAVOC score nor premature atrial contractions frequency', 'HAVOC score, left atrial diameter, and premature atrial contraction frequency', 'stroke risk', 'recurrent ischemic stroke', 'left atrial diameter']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0741276'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4517633', 'cui_str': 'Two point six'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0033036', 'cui_str': 'Premature Atrial Contractions'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C3888970', 'cui_str': 'Embolic stroke of undetermined source'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0033036', 'cui_str': 'Premature Atrial Contractions'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C1277291', 'cui_str': 'Stroke risk'}]",7112.0,0.0790898,"Rivaroxaban was associated with a reduced risk of recurrent stroke among patients with ESUS and moderate or severe left atrial enlargement; however, this needs to be independently confirmed before influencing clinical practice.","[{'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Healey', 'Affiliation': 'Division of Cardiology, Hamilton Health Sciences, Population Health Research Institute, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Gladstone', 'Affiliation': 'Division of Neurology and Hurvitz Brain Sciences Program, Sunnybrook Health Sciences Centre and Sunnybrook Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Balakumar', 'Initials': 'B', 'LastName': 'Swaminathan', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Eckstein', 'Affiliation': 'Department of Internal Medicine, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Hardi', 'Initials': 'H', 'LastName': 'Mundl', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Epstein', 'Affiliation': 'Electrophysiology Section, Cardiovascular Division University of Pennsylvania, Cardiology Section, Philadelphia VA Medical Center, Philadelphia.'}, {'ForeName': 'Karl Georg', 'Initials': 'KG', 'LastName': 'Haeusler', 'Affiliation': 'Department of Neurology, Universitätsklinikum Würzburg, Würzburg, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Mikulik', 'Affiliation': ""International Clinical Research Center and Neurology Department, St. Anne's University Hospital and Masaryk University, Brno, Czech Republic.""}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Kasner', 'Affiliation': 'Department of Neurology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'Toni', 'Affiliation': 'Department of Human Neurosciences, ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Arauz', 'Affiliation': 'Instituto Nacional de Neurologia y Neurocirugia, Mexico D.F., Mexico City, Mexico.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Ntaios', 'Affiliation': 'Department of Medicine, University of Thesally, Larissa, Greece.'}, {'ForeName': 'Graeme J', 'Initials': 'GJ', 'LastName': 'Hankey', 'Affiliation': 'UWA Medical School, University of Western Australia, Sir Charles Gairdner Hospital, Perth, Australia.'}, {'ForeName': 'Kanjana', 'Initials': 'K', 'LastName': 'Perera', 'Affiliation': 'McMaster University/Population Health Research Institute, Department of Medicine (Neurology), Hamilton, Ontario, Canada.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Pagola', 'Affiliation': ""Unitat d'Ictus, Servei de Neurologia, Hospital Universitari Vall d'Hebrón, Barcelona, Spain.""}, {'ForeName': 'Ashfaq', 'Initials': 'A', 'LastName': 'Shuaib', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Helmi', 'Initials': 'H', 'LastName': 'Lutsep', 'Affiliation': 'Department of Neurology, OHSU, VA Portland Health Care System, Portland, Oregon.'}, {'ForeName': 'Xiaomeng', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Uchiyama', 'Affiliation': 'International University of Health and Welfare, Sanno Hospital and Sanno Medical Center, Tokyo, Japan.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Endres', 'Affiliation': 'Klinik für Neurologie, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Shelagh B', 'Initials': 'SB', 'LastName': 'Coutts', 'Affiliation': 'Department of Clinical Neurosciences, Radiology, and Community Health Sciences, University of Calgary, Foothills Medical Centre, Calgary, Alberta, Canada.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Karlinski', 'Affiliation': 'Department of Neurology, Institute of Psychiatry and Neurology, Warsaw, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Czlonkowska', 'Affiliation': '2nd Department of Neurology, Institute of Psychiatry and Neurology, Warsaw, Poland.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Molina', 'Affiliation': 'Department of Pharmacology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Santo', 'Affiliation': 'Neurology Department, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Bayer US LLC, Pharmaceuticals Clinical Development Thrombosis, Whippany, New Jersey.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Hart', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'Division of Cardiology, Hamilton Health Sciences, Population Health Research Institute, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}]",JAMA neurology,['10.1001/jamaneurol.2019.0617']
533,30958514,Effects of Mindfulness Yoga vs Stretching and Resistance Training Exercises on Anxiety and Depression for People With Parkinson Disease: A Randomized Clinical Trial.,"Importance


Clinical practice guidelines support exercise for patients with Parkinson disease (PD), but to our knowledge, no randomized clinical trials have tested whether yoga is superior to conventional physical exercises for stress and symptom management.
Objective


To compare the effects of a mindfulness yoga program vs stretching and resistance training exercise (SRTE) on psychological distress, physical health, spiritual well-being, and health-related quality of life (HRQOL) in patients with mild-to-moderate PD.
Design, Setting, and Participants


An assessor-masked, randomized clinical trial using the intention-to-treat principle was conducted at 4 community rehabilitation centers in Hong Kong between December 1, 2016, and May 31, 2017. A total of 187 adults (aged ≥18 years) with a clinical diagnosis of idiopathic PD who were able to stand unaided and walk with or without an assistive device were enrolled via convenience sampling. Eligible participants were randomized 1:1 to mindfulness yoga or SRTE.
Interventions


Mindfulness yoga was delivered in 90-minute groups and SRTE were delivered in 60-minute groups for 8 weeks.
Main Outcomes and Measures


Primary outcomes included anxiety and depressive symptoms assessed using the Hospital Anxiety and Depression Scale. Secondary outcomes included severity of motor symptoms (Movement Disorder Society Unified Parkinson's Disease Rating Scale [MDS-UPDRS], Part III motor score), mobility, spiritual well-being in terms of perceived hardship and equanimity, and HRQOL. Assessments were done at baseline, 8 weeks (T1), and 20 weeks (T2).
Results


The 138 participants included 65 men (47.1%) with a mean (SD) age of 63.7 (8.7) years and a mean (SD) MDS-UPDRS score of 33.3 (15.3). Generalized estimating equation analyses revealed that the yoga group had significantly better improvement in outcomes than the SRTE group, particularly for anxiety (time-by-group interaction, T1: β, -1.79 [95% CI, -2.85 to -0.69; P = .001]; T2: β, -2.05 [95% CI, -3.02 to -1.08; P < .001]), depression (T1: β, -2.75 [95% CI, -3.17 to -1.35; P < .001]); T2: β, -2.75 [95% CI, -3.71 to -1.79; P < .001]), perceived hardship (T1: β, -0.92 [95% CI, -1.25 to -0.61; P < .001]; T2: β, -0.76 [95% CI, -1.12 to -0.40; P < .001]), perceived equanimity (T1: β, 1.11 [95% CI, 0.79-1.42; P < .001]; T2: β, 1.19 [95% CI, 0.82-1.56; P < .001]), and disease-specific HRQOL (T1: β, -7.77 [95% CI, -11.61 to -4.38; P < .001]; T2: β, -7.99 [95% CI, -11.61 to -4.38; P < .001]).
Conclusions and Relevance


Among patients with mild-to-moderate PD, the mindfulness yoga program was found to be as effective as SRTE in improving motor dysfunction and mobility, with the additional benefits of a reduction in anxiety and depressive symptoms and an increase in spiritual well-being and HRQOL.
Trial Registration


Centre for Clinical Research and Biostatistics identifier: CUHK_CCRB00522.",2019,"Generalized estimating equation analyses revealed that the yoga group had significantly better improvement in outcomes than the SRTE group, particularly for anxiety (time-by-group interaction, T1: β,","['patients with Parkinson disease (PD', '187 adults (aged ≥18 years) with a clinical diagnosis of idiopathic PD who were able to stand unaided and walk with or without an assistive device were enrolled via convenience sampling', '138 participants included 65 men (47.1%) with a mean (SD) age of 63.7 (8.7) years and a mean (SD) MDS-UPDRS score of 33.3 (15.3', 'People With Parkinson Disease', '4 community rehabilitation centers in Hong Kong between December 1, 2016, and May 31, 2017', 'Eligible participants', 'patients with mild-to-moderate PD']","['mindfulness yoga program vs stretching and resistance training exercise (SRTE', 'Mindfulness Yoga vs Stretching and Resistance Training Exercises', 'mindfulness yoga or SRTE']","['disease-specific HRQOL ', 'psychological distress, physical health, spiritual well-being, and health-related quality of life (HRQOL', ""severity of motor symptoms (Movement Disorder Society Unified Parkinson's Disease Rating Scale [MDS-UPDRS], Part III motor score), mobility, spiritual well-being in terms of perceived hardship and equanimity, and HRQOL"", 'anxiety and depressive symptoms assessed using the Hospital Anxiety and Depression Scale', 'Anxiety and Depression', 'anxiety and depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0560884', 'cui_str': 'Able to stand (finding)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0036605', 'cui_str': 'Assistive Technology'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517880', 'cui_str': '8.7 (qualifier value)'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4517716', 'cui_str': 'Thirty-three point three'}, {'cui': 'C4517578', 'cui_str': '15.3'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0034993', 'cui_str': 'Rehabilitation Centers'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms (finding)'}, {'cui': 'C0026650', 'cui_str': 'Movement Disorder Syndromes'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",187.0,0.193096,"Generalized estimating equation analyses revealed that the yoga group had significantly better improvement in outcomes than the SRTE group, particularly for anxiety (time-by-group interaction, T1: β,","[{'ForeName': 'Jojo Y Y', 'Initials': 'JYY', 'LastName': 'Kwok', 'Affiliation': 'School of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region.'}, {'ForeName': 'Jackie C Y', 'Initials': 'JCY', 'LastName': 'Kwan', 'Affiliation': 'The Hong Kong Society for Rehabilitation, Hong Kong Special Administrative Region.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Auyeung', 'Affiliation': 'Department of Medicine, Pamela Youde Nethersole Eastern Hospital, Chai Wan, Hong Kong Special Administrative Region.'}, {'ForeName': 'Vincent C T', 'Initials': 'VCT', 'LastName': 'Mok', 'Affiliation': 'Department of Medicine and Therapeutics, Therese Pei Fong Chow Research Center for Prevention of Dementia, Gerald Choa Neuroscience Centre, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong Special Administrative Region.'}, {'ForeName': 'Claire K Y', 'Initials': 'CKY', 'LastName': 'Lau', 'Affiliation': 'Department of Medicine and Therapeutics, Prince of Wales Hospital, Hong Kong Special Administration Region.'}, {'ForeName': 'K C', 'Initials': 'KC', 'LastName': 'Choi', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong Special Administrative Region.'}, {'ForeName': 'Helen Y L', 'Initials': 'HYL', 'LastName': 'Chan', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong Special Administrative Region.'}]",JAMA neurology,['10.1001/jamaneurol.2019.0534']
534,31454829,Acute kidney injury risk-based screening in pediatric inpatients: a pragmatic randomized trial.,"BACKGROUND


Pediatric acute kidney injury (AKI) is common and associated with increased morbidity, mortality, and length of stay. We performed a pragmatic randomized trial testing the hypothesis that AKI risk alerts increase AKI screening.
METHODS


All intensive care and ward admissions of children aged 28 days through 21 years without chronic kidney disease from 12/6/2016 to 11/1/2017 were included. The intervention alert displayed if calculated AKI risk was > 50% and no serum creatinine (SCr) was ordered within 24 h. The primary outcome was SCr testing within 48 h of AKI risk > 50%.
RESULTS


Among intensive care admissions, 973/1909 (51%) were randomized to the intervention. Among those at risk, more SCr tests were ordered for the intervention group than for controls (418/606, 69% vs. 361/597, 60%, p = 0.002). AKI incidence and severity were the same in intervention and control groups. Among ward admissions, 5492/10997 (50%) were randomized to the intervention, and there were no differences between groups in SCr testing, AKI incidence, or severity of AKI.
CONCLUSIONS


Alerts based on real-time prediction of AKI risk increased screening rates in intensive care but not pediatric ward settings. Pragmatic clinical trials provide the opportunity to assess clinical decision support and potentially eliminate ineffective alerts.",2020,AKI incidence and severity were the same in intervention and control groups.,"['pediatric inpatients', 'All intensive care and ward admissions of children aged 28 days through 21 years without chronic kidney disease from 12/6/2016 to 11/1/2017 were included']",[],"['serum creatinine (SCr', 'SCr tests', 'AKI incidence and severity', 'morbidity, mortality, and length of stay', 'SCr testing within 48\u2009h of AKI risk', 'SCr testing, AKI incidence, or severity of AKI', 'calculated AKI risk']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0085559'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]",[],"[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.192399,AKI incidence and severity were the same in intervention and control groups.,"[{'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'Van Driest', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA. sara.van.driest@vumc.org.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'McLemore', 'Affiliation': 'Health Information Technology, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Bridges', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Geoffrey M', 'Initials': 'GM', 'LastName': 'Fleming', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'McGregor', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Deborah P', 'Initials': 'DP', 'LastName': 'Jones', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Shirey-Rice', 'Affiliation': 'Institute for Clinical and Translational Research, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Gatto', 'Affiliation': 'Institute for Clinical and Translational Research, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Gay', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Byrne', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Asli', 'Initials': 'A', 'LastName': 'Weitkamp', 'Affiliation': 'Department of Biomedical Informatics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Dan M', 'Initials': 'DM', 'LastName': 'Roden', 'Affiliation': 'Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Bernard', 'Affiliation': 'Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.'}]",Pediatric research,['10.1038/s41390-019-0550-1']
535,31219558,A Randomized Placebo-Controlled Trial of Low-Dose Testosterone Therapy in Women With Anorexia Nervosa.,"CONTEXT


Anorexia nervosa (AN) is a psychiatric illness with considerable morbidity and no approved medical therapies. We have shown that relative androgen deficiency in AN is associated with greater depression and anxiety symptom severity.
OBJECTIVE


To determine whether low-dose testosterone therapy is an effective endocrine-targeted therapy for AN.
DESIGN


Double-blind, randomized, placebo-controlled trial.
SETTING


Clinical research center.
PARTICIPANTS


Ninety women, 18 to 45 years, with AN and free testosterone levels below the median for healthy women.
INTERVENTION


Transdermal testosterone, 300 μg daily, or placebo patch for 24 weeks.
MAIN OUTCOME MEASURES


Primary end point: body mass index (BMI). Secondary end points: depression symptom severity [Hamilton Depression Rating Scale (HAM-D)], anxiety symptom severity [Hamilton Anxiety Rating Scale (HAM-A)], and eating disorder psychopathology and behaviors.
RESULTS


Mean BMI increased by 0.0 ± 1.0 kg/m2 in the testosterone group and 0.5 ± 1.1 kg/m2 in the placebo group (P = 0.03) over 24 weeks. At 4 weeks, there was a trend toward a greater decrease in HAM-D score (P = 0.09) in the testosterone vs placebo group. At 24 weeks, mean HAM-D and HAM-A scores decreased similarly in both groups [HAM-D: -2.9 ± 4.9 (testosterone) vs -3.0 ± 5.0 (placebo), P = 0.72; HAM-A: -4.5 ± 5.3 (testosterone) vs -4.3 ± 4.4 (placebo), P = 0.25]. There were no significant differences in eating disorder scores between groups. Testosterone therapy was safe and well tolerated with no increase in androgenic side effects compared with placebo.
CONCLUSION


Low-dose testosterone therapy for 24 weeks was associated with less weight gain-and did not lead to sustained improvements in depression, anxiety, or disordered eating symptoms-compared with placebo in women with AN.",2019,"CONCLUSIONS


Low-dose testosterone therapy for 24 weeks was associated with less weight gain - and did not lead to sustained improvements in depression, anxiety, or disordered eating symptoms - compared to placebo in women with AN.","['women with anorexia nervosa', '90 women, 18-45 years, with AN and free testosterone levels below the median for healthy women']","['testosterone', 'placebo', 'low-dose testosterone therapy', 'Testosterone therapy', 'Transdermal testosterone', 'placebo patch']","['HAM-D score', 'eating disorder scores', 'depression, anxiety, or disordered eating symptoms ', 'weight gain ', 'depression symptom severity [Hamilton Depression Rating Scale (HAM-D)], anxiety symptom severity [Hamilton Anxiety Rating Scale (HAM-A)], and eating disorder psychopathology and behaviors', 'mean HAM-D and HAM-A scores', 'Mean BMI', 'androgenic side effects']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0003125', 'cui_str': 'Anorexia Nervosas'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0443483', 'cui_str': 'Free testosterone (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}]","[{'cui': 'C3853311', 'cui_str': 'Ham'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",90.0,0.738216,"CONCLUSIONS


Low-dose testosterone therapy for 24 weeks was associated with less weight gain - and did not lead to sustained improvements in depression, anxiety, or disordered eating symptoms - compared to placebo in women with AN.","[{'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Kimball', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Schorr', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Erinne', 'Initials': 'E', 'LastName': 'Meenaghan', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Katherine N', 'Initials': 'KN', 'LastName': 'Bachmann', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Kamryn T', 'Initials': 'KT', 'LastName': 'Eddy', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Madhusmita', 'Initials': 'M', 'LastName': 'Misra', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Lawson', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Elana', 'Initials': 'E', 'LastName': 'Kreiger-Benson', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Herzog', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Koman', 'Affiliation': 'Walden Behavioral Care, Waltham, Massachusetts.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Keane', 'Affiliation': 'Walden Behavioral Care, Waltham, Massachusetts.'}, {'ForeName': 'Seda', 'Initials': 'S', 'LastName': 'Ebrahimi', 'Affiliation': 'Cambridge Eating Disorder Center, Cambridge, Massachusetts.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schoenfeld', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Klibanski', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Karen K', 'Initials': 'KK', 'LastName': 'Miller', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital, Boston, Massachusetts.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00828']
536,31222044,Randomised clinical trial of ferric citrate hydrate on anaemia management in haemodialysis patients with hyperphosphataemia: ASTRIO study.,"Ferric citrate hydrate (FC) is an iron-based phosphate binder approved for hyperphosphataemia in patients with chronic kidney disease. We conducted a randomised controlled trial to evaluate the effects of FC on anaemia management in haemodialysis patients with hyperphosphataemia. We 1:1 randomised 93 patients who were undergoing haemodialysis and being treated with non-iron-based phosphate binders and erythropoiesis-stimulating agents (ESA) to receive 24 weeks of FC or to continue their non-iron-based phosphate binders (control) in a multicentre, open-label, parallel-design. Phosphate level was controlled within target range (3.5-6.0 mg/dL). The primary endpoint was change in ESA dose from baseline to end of treatment. Secondary endpoints were changes in red blood cell, iron and mineral, and bone-related parameters. Compared with control, FC reduced ESA dose [mean change (SD), -1211.8 (3609.5) versus +1195 (6662.8) IU/week; P = 0.03] without significant differences in haemoglobin. FC decreased red blood cell distribution width (RDW) compared with control. While there were no changes in serum phosphate, FC reduced C-terminal fibroblast growth factor (FGF) 23 compared with control. The incidence of adverse events did not differ significantly between groups. Despite unchanged phosphate and haemoglobin levels, FC reduced ESA dose, RDW, and C-terminal FGF23 compared with control.",2019,"Despite unchanged phosphate and haemoglobin levels, FC reduced ESA dose, RDW, and C-terminal FGF23 compared with control.","['93 patients who were undergoing haemodialysis and being treated with non-iron-based phosphate binders and erythropoiesis-stimulating agents (ESA) to receive 24 weeks of', 'haemodialysis patients with hyperphosphataemia', 'patients with chronic kidney disease']","['FC or to continue their non-iron-based phosphate binders (control', 'ferric citrate hydrate', 'FC', 'Ferric citrate hydrate (FC']","['anaemia management', 'Phosphate level', 'phosphate and haemoglobin levels, FC reduced ESA dose, RDW, and C-terminal FGF23', 'changes in red blood cell, iron and mineral, and bone-related parameters', 'change in ESA dose', 'FC decreased red blood cell distribution width (RDW', 'serum phosphate, FC reduced C-terminal fibroblast growth factor (FGF', 'incidence of adverse events', 'haemoglobin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0179302', 'cui_str': 'Binder'}, {'cui': 'C1959590', 'cui_str': 'Erythropoiesis Stimulating Agents'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0085681', 'cui_str': 'Hyperphosphatemias'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}]","[{'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0179302', 'cui_str': 'Binder'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4041572'}]","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0523826', 'cui_str': 'Phosphate measurement (procedure)'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C3472649', 'cui_str': 'ESAS'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0036820', 'cui_str': 'Serum phosphate'}, {'cui': 'C1829744', 'cui_str': 'Fibroblast growth factor, C-terminal'}, {'cui': 'C0016026', 'cui_str': 'DNA Synthesis Factor'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0512347,"Despite unchanged phosphate and haemoglobin levels, FC reduced ESA dose, RDW, and C-terminal FGF23 compared with control.","[{'ForeName': 'Keitaro', 'Initials': 'K', 'LastName': 'Yokoyama', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan. keitaro@jikei.ac.jp.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Fukagawa', 'Affiliation': 'Division of Nephrology, Endocrinology and Metabolism, Tokai University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Akiba', 'Affiliation': 'Tokyo Next Medical & Hemodialysis Clinic, Tokyo, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Nakayama', 'Affiliation': 'Tohoku University Hospital, Miyagi, Japan.'}, {'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Medical Affairs Department, Torii Pharmaceutical Co. Ltd., Tokyo, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Hanaki', 'Affiliation': 'Pharmaceutical Division, Japan Tobacco Inc., Tokyo, Japan.'}, {'ForeName': 'Myles', 'Initials': 'M', 'LastName': 'Wolf', 'Affiliation': 'Division of Nephrology, Department of Medicine, and Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Hirakata', 'Affiliation': 'Fukuoka Renal Clinic, Fukuoka, Japan.'}]",Scientific reports,['10.1038/s41598-019-45335-4']
537,31904760,The Combination of Whey Protein and Dietary Fiber Does Not Alter Low-Grade Inflammation or Adipose Tissue Gene Expression in Adults with Abdominal Obesity.,"BACKGROUND


Abdominal obesity is characterized by low-grade inflammation and plays a central role in the development of type 2 diabetes and cardiovascular diseases. Dietary factors can influence low-grade inflammation and affect adipose tissue function.
AIM


To investigate the separate and combined effects of whey protein and cereal fiber on inflammatory markers and adipose tissue gene expression in abdominal obesity.
METHODS


We performed a 12-week, double-blind, randomized controlled dietary intervention in 65 adults with abdominal obesity. The participants were randomized to 4 groups using a 2 × 2 factorial design; they received either 60 g/day of whey protein or maltodextrin in combination with high-fiber wheat bran products (30 g fiber/day) or low-fiber refined wheat products (10 g fiber/day). Plasma concentrations of tumor necrosis factor α (TNF-α), high-sensitivity C-reactive protein (hs-CRP), monocyte chemoattractant protein-1 (MCP-1), interleukin 1 receptor antagonist (IL-1Ra), and adiponectin were measured before and after intervention. Changes in gene expression related to inflammation, insulin signaling, and lipid metabolism were measured in abdominal subcutaneous adipose tissue.
RESULTS


After intervention, TNF-α was reduced for both high-fiber groups compared with baseline, but did not significantly differ from the low-fiber groups. There were no differences in fasting or postprandial inflammatory markers between the groups. The relative gene expression of ribosomal protein S6 kinase B1 (S6K1) was increased after whey protein compared with maltodextrin consumption.
CONCLUSION


Intake of whey protein in combination with high cereal fiber content did not differentially affect low-grade inflammation or adipose tissue gene expression compared with maltodextrin and low fiber content in individuals with abdominal obesity.",2019,"The relative gene expression of ribosomal protein S6 kinase B1 (S6K1) was increased after whey protein compared with maltodextrin consumption.
","['individuals with abdominal obesity', 'Adults with Abdominal Obesity', '65 adults with abdominal obesity']","['whey protein and cereal fiber', 'Whey Protein and Dietary Fiber', 'maltodextrin', 'whey protein or maltodextrin in combination with high-fiber wheat bran products']","['low-grade inflammation or adipose tissue gene expression', 'relative gene expression of ribosomal protein S6 kinase B1 (S6K1', 'TNF-α', 'fasting or postprandial inflammatory markers', 'inflammation, insulin signaling, and lipid metabolism', 'Plasma concentrations of tumor necrosis factor α (TNF-α), high-sensitivity C-reactive protein (hs-CRP), monocyte chemoattractant protein-1 (MCP-1), interleukin 1 receptor antagonist (IL-1Ra), and adiponectin']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0311277', 'cui_str': 'Central Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0007757', 'cui_str': 'Cereal Grain'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0012173', 'cui_str': 'Dietary Fiber'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0043138', 'cui_str': 'Wheat Bran'}]","[{'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0073337', 'cui_str': 'S6-H4 Kinase'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0128897', 'cui_str': 'Chemokine (C-C Motif) Ligand 2'}, {'cui': 'C2317059', 'cui_str': 'Interleukin 1 receptor antagonist product'}, {'cui': 'C1704264', 'cui_str': 'IL-1 Inhibitor, Urine'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}]",65.0,0.044585,"The relative gene expression of ribosomal protein S6 kinase B1 (S6K1) was increased after whey protein compared with maltodextrin consumption.
","[{'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Rakvaag', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, 8200 Aarhus N, Denmark.'}, {'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Fuglsang-Nielsen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, 8200 Aarhus N, Denmark.'}, {'ForeName': 'Knud Erik', 'Initials': 'KE', 'LastName': 'Bach Knudsen', 'Affiliation': 'Department of Animal Science, Aarhus University, 8830 Tjele, Denmark.'}, {'ForeName': 'Kjeld', 'Initials': 'K', 'LastName': 'Hermansen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, 8200 Aarhus N, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Gregersen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, 8200 Aarhus N, Denmark.'}]",The review of diabetic studies : RDS,['10.1900/RDS.2019.15.83']
538,32264706,A randomized clinical trial comparing prompt photodynamic therapy with 3 months observation in patients with acute central serous chorioretinopathy with central macular leakage.,"PURPOSE


The purpose of the study was to demonstrate whether photodynamic therapy in patients with acute central serous chorioretinopathy, with the leakage point within one optic disk diameter from the fovea, can be safely deferred.
METHODS


A single-center, randomized, controlled trial was conducted. Patients were randomized to photodynamic therapy within a week after presentation (Group I, 26 patients) or observation during 3 months (Group II, 26 patients). If leakage or subretinal fluid was observed during any control visit, photodynamic therapy was performed (again) within a week.
PRIMARY OUTCOME


Primary outcome was change of visual acuity (Early Treatment Diabetic Retinopathy Study) after 12 months. Secondary outcomes were visual acuity, central foveal thickness, metamorphopsia, and color discrimination.
RESULTS


Photodynamic therapy procedures: group I, 26 at baseline, 2 retreatments at 3 months; group II, 10 at 3 months, 1 at 6 months (2 subjects refusing treatment), 2 retreatments at 6 months. At 12 months, mean visual acuity of all patients had improved by 6.5 letters (P < 0.001), mean central foveal thickness was 172 µm less (P < 0.001). After photodynamic therapy, visual acuity recovered faster and metamorphopsia significantly improved (3 months, P < 0.001). Differences between groups at 12 months were not significant.
CONCLUSION


The (intended) number of photodynamic therapy (re)treatments in group II (n = 15) was 46% less than in group I (n = 28). Visual acuity and central foveal thickness at 12 months were similar. Therefore, the preferred management of acute central serous chorioretinopathy at presentation appears to be observation for 3 months.",2020,"At 12 months, mean visual acuity of all patients had improved by 6.5 letters (P < 0.001), mean central foveal thickness was 172 µm less (P < 0.001).","['patients with acute central serous chorioretinopathy, with the leakage point within one optic disk diameter from the fovea, can be safely deferred', 'patients with acute central serous chorioretinopathy with central macular leakage']",['photodynamic therapy'],"['change of visual acuity (Early Treatment Diabetic Retinopathy Study', 'Visual acuity and central foveal thickness', 'mean visual acuity', 'visual acuity, central foveal thickness, metamorphopsia, and color discrimination', 'mean central foveal thickness', 'visual acuity recovered faster and metamorphopsia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0730315', 'cui_str': 'Acute central serous chorioretinopathy'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0029127', 'cui_str': 'Optic disc structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0016622', 'cui_str': 'Structure of fovea centralis'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0271185', 'cui_str': 'Metamorphopsia'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}]",,0.228035,"At 12 months, mean visual acuity of all patients had improved by 6.5 letters (P < 0.001), mean central foveal thickness was 172 µm less (P < 0.001).","[{'ForeName': 'Tom Oar', 'Initials': 'TO', 'LastName': 'Missotten', 'Affiliation': 'The Rotterdam Eye Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Johan G', 'Initials': 'JG', 'LastName': 'Hoddenbach', 'Affiliation': 'The Rotterdam Eye Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Christine Ae', 'Initials': 'CA', 'LastName': 'Eenhorst', 'Affiliation': 'The Rotterdam Eye Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'L Ingeborgh', 'Initials': 'LI', 'LastName': 'van den Born', 'Affiliation': 'The Rotterdam Eye Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'José P', 'Initials': 'JP', 'LastName': 'Martinez Ciriano', 'Affiliation': 'The Rotterdam Eye Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'René J', 'Initials': 'RJ', 'LastName': 'Wubbels', 'Affiliation': 'The Rotterdam Eye Hospital, Rotterdam, The Netherlands.'}]",European journal of ophthalmology,['10.1177/1120672120915168']
539,32252100,Influence of Respiratory Muscle Training on Patients' Recovery after Lung Resection.,"This prospective experimental study aimed to compare effects of 3 different home-based postoperative respiratory muscle training protocols - inspiratory, expiratory and combined, in the patients' postoperative recovery, regarding safety and respiratory muscle function, pulmonary function, physical fitness, physical activity (PA), dyspnoea and quality of life (QoL). Patients were divided in four groups Usual Care (UCare), inspiratory (IMT), expiratory (EMT) or combined muscle training (CombT) according to group allocation. Significant treatment*time interactions were found for maximal inspiratory pressure (MIP) (p=0.014), sedentary PA (SEDPA) (p=0.003), light PA (LIGPA) (p=0.045) and total PA (p=0.035). Improvements were observed for MIP in CombT (p=0.001), IMT (p=0.001), EMT (p=0.050). SEDPA reduced in EMT (p=0.001) and IMT (p=0.006), while LIGPA increased in both groups (p=0.001), as well as Total PA (p=0.005 and p=0.001, respectively). In UCare, CombT, and EMT, QoL improved only for Usual Activities. In conclusion, the addition of respiratory muscle training to physiotherapy usual care is safe and effective to increase MIP and contribute to improve physical activity. The CombT showed greater improvement on MIP, while IMT compared to EMT, was more effective to improve physical activity.",2020,"Significant treatment*time interactions were found for maximal inspiratory pressure (MIP) (p=0.014), sedentary PA (SEDPA) (p=0.003), light PA (LIGPA) (p=0.045) and total PA (p=0.035).","[""Patients' Recovery after Lung Resection""]","['EMT', '3 different home-based postoperative respiratory muscle training protocols - inspiratory, expiratory and combined', 'Usual Care (UCare), inspiratory (IMT), expiratory (EMT) or combined muscle training (CombT) according to group allocation', 'Respiratory Muscle Training']","['MIP in CombT', 'physical activity', 'light PA (LIGPA', 'LIGPA', 'MIP', 'safety and respiratory muscle function, pulmonary function, physical fitness, physical activity (PA), dyspnoea and quality of life (QoL', 'total PA', 'sedentary PA (SEDPA', 'SEDPA reduced in EMT', 'maximal inspiratory pressure (MIP', 'Total PA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0396565', 'cui_str': 'Lung excision'}]","[{'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0376579', 'cui_str': 'Macrophage Inflammatory Proteins'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}]",,0.0146692,"Significant treatment*time interactions were found for maximal inspiratory pressure (MIP) (p=0.014), sedentary PA (SEDPA) (p=0.003), light PA (LIGPA) (p=0.045) and total PA (p=0.035).","[{'ForeName': 'Filipa', 'Initials': 'F', 'LastName': 'Kendall', 'Affiliation': 'Research Centre in Physical Activity, Health and Leisure (CIAFEL), Faculty of Sport, University of Porto, Porto, Portugal.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Silva', 'Affiliation': 'Research Center in Sports Sciences, Health and Human Development (CIDESD), University Institute of Maia (ISMAI), Maia, Portugal.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Almeida', 'Affiliation': 'Sleep Medicine Department, Hospital CUF, Porto, Portugal.'}, {'ForeName': 'Ermelinda', 'Initials': 'E', 'LastName': 'Eusébio', 'Affiliation': 'Pulmonology Department, Centro Hospitalar São João, Porto, Portugal.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Pinho', 'Affiliation': 'Department of Cardiothoracic Surgery, Centro Hospitalar São João, Porto, Portugal.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Oliveira', 'Affiliation': 'Research Centre in Physical Activity, Health and Leisure (CIAFEL), Faculty of Sport, University of Porto, Porto, Portugal.'}, {'ForeName': 'Pedro Teixeira', 'Initials': 'PT', 'LastName': 'Bastos', 'Affiliation': 'Department of Cardiothoracic Surgery, Centro Hospitalar São João, Porto, Portugal.'}]",International journal of sports medicine,['10.1055/a-1096-0913']
540,31980913,"Autologous monocyte-derived DC vaccination combined with cisplatin in stage III and IV melanoma patients: a prospective, randomized phase 2 trial.","BACKGROUND


Autologous dendritic cell (DC) vaccines can induce tumor-specific T cells, but their effect can be counteracted by immunosuppressive mechanisms. Cisplatin has shown immunomodulatory effects in vivo which may enhance efficacy of DC vaccination.
METHODS


This is a prospective, randomized, open-label phase 2 study (NCT02285413) including stage III and IV melanoma patients receiving 3 biweekly vaccinations of gp100 and tyrosinase mRNA-loaded monocyte-derived DCs with or without cisplatin. Primary objectives were to study immunogenicity and feasibility, and secondary objectives were to assess toxicity and survival.
RESULTS


Twenty-two stage III and 32 stage IV melanoma patients were analyzed. Antigen-specific CD8 +  T cells were found in 44% versus 67% and functional T cell responses in 28% versus 19% of skin-test infiltrating lymphocytes in patients receiving DC vaccination with and without cisplatin, respectively. Four patients stopped cisplatin because of toxicity and continued DC monotherapy. No therapy-related grade 3 or 4 adverse events occurred due to DC monotherapy. During combination therapy, one therapy-related grade 3 adverse event, decompensated heart failure due to fluid overload, occurred. The clinical outcome parameters did not clearly suggest significant differences.
CONCLUSIONS


Combination of DC vaccination and cisplatin in melanoma patients is feasible and safe, but does not seem to result in more tumor-specific T cell responses or improved clinical outcome, when compared to DC vaccination monotherapy.",2020,"Antigen-specific CD8 +  T cells were found in 44% versus 67% and functional T cell responses in 28% versus 19% of skin-test infiltrating lymphocytes in patients receiving DC vaccination with and without cisplatin, respectively.","['melanoma patients', 'Twenty-two stage III and 32 stage IV melanoma patients', 'stage III and IV melanoma patients', 'stage III and IV melanoma patients receiving 3 biweekly']","['Cisplatin', 'DC vaccination and cisplatin', 'vaccinations of gp100 and tyrosinase mRNA-loaded monocyte-derived DCs with or without cisplatin', 'cisplatin', 'Autologous monocyte-derived DC vaccination combined with cisplatin', 'Autologous dendritic cell (DC) vaccines']","['Antigen-specific CD8 +  T cells', 'toxicity and survival', 'functional T cell responses']","[{'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0585332', 'cui_str': 'Biweekly (qualifier value)'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0041484', 'cui_str': 'Phenol Oxidase'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0011306', 'cui_str': 'Dendritic Cells'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",,0.312128,"Antigen-specific CD8 +  T cells were found in 44% versus 67% and functional T cell responses in 28% versus 19% of skin-test infiltrating lymphocytes in patients receiving DC vaccination with and without cisplatin, respectively.","[{'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Boudewijns', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Bloemendal', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Nienke', 'Initials': 'N', 'LastName': 'de Haas', 'Affiliation': 'Department of Tumor Immunology, Radboud University Medical Center, Radboud Institute for Molecular Life Sciences, PO Box 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Harm', 'Initials': 'H', 'LastName': 'Westdorp', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Kalijn F', 'Initials': 'KF', 'LastName': 'Bol', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Gerty', 'Initials': 'G', 'LastName': 'Schreibelt', 'Affiliation': 'Department of Tumor Immunology, Radboud University Medical Center, Radboud Institute for Molecular Life Sciences, PO Box 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Erik H J G', 'Initials': 'EHJG', 'LastName': 'Aarntzen', 'Affiliation': 'Department of Tumor Immunology, Radboud University Medical Center, Radboud Institute for Molecular Life Sciences, PO Box 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'W Joost', 'Initials': 'WJ', 'LastName': 'Lesterhuis', 'Affiliation': 'Department of Tumor Immunology, Radboud University Medical Center, Radboud Institute for Molecular Life Sciences, PO Box 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Mark A J', 'Initials': 'MAJ', 'LastName': 'Gorris', 'Affiliation': 'Department of Tumor Immunology, Radboud University Medical Center, Radboud Institute for Molecular Life Sciences, PO Box 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Croockewit', 'Affiliation': 'Department of Hematology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Lieke L', 'Initials': 'LL', 'LastName': 'van der Woude', 'Affiliation': 'Department of Tumor Immunology, Radboud University Medical Center, Radboud Institute for Molecular Life Sciences, PO Box 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'van Rossum', 'Affiliation': 'Department of Dermatology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Welzen', 'Affiliation': 'Department of Pharmacy, Radboud University Medical center, Nijmegen, The Netherlands.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'de Goede', 'Affiliation': 'Department of Pharmacy, Radboud University Medical center, Nijmegen, The Netherlands.'}, {'ForeName': 'Stanleyson V', 'Initials': 'SV', 'LastName': 'Hato', 'Affiliation': 'Department of Tumor Immunology, Radboud University Medical Center, Radboud Institute for Molecular Life Sciences, PO Box 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Winette T A', 'Initials': 'WTA', 'LastName': 'van der Graaf', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Cornelis J A', 'Initials': 'CJA', 'LastName': 'Punt', 'Affiliation': 'Department of Medical Oncology, Academic University Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Rutger H T', 'Initials': 'RHT', 'LastName': 'Koornstra', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Winald R', 'Initials': 'WR', 'LastName': 'Gerritsen', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Carl G', 'Initials': 'CG', 'LastName': 'Figdor', 'Affiliation': 'Department of Tumor Immunology, Radboud University Medical Center, Radboud Institute for Molecular Life Sciences, PO Box 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'I Jolanda M', 'Initials': 'IJM', 'LastName': 'de Vries', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands. jolanda.devries@radboudumc.nl.'}]","Cancer immunology, immunotherapy : CII",['10.1007/s00262-019-02466-x']
541,32195930,"Clinical effects of Shou-Wu Jiang-Qi Decoction combined acupuncture on the treatment of Polycystic Ovarian Syndrome with kidney deficiency, phlegm and blood stasisness: Study protocol clinical trial (SPIRIT Compliant).","BACKGROUND


Polycystic ovary syndrome (PCOS) is a female endocrine disease with a high incidence. At present, drug treatment is still the main therapeutic strategy for PCOS. Traditional Chinese medicine has a long history in the treatment of menstrual disorders. Shouwu Jiangqi Decoction (SWJQD) is a traditional herbal medicine prescribed in a clinical setting as a remedy for PCOS. Acupuncture also plays an important role in regulating the menstrual cycle and treating PCOS. This study aims to examine the efficacy and safety of the combination of SWJQD and acupuncture in the treatment of PCOS.
METHODS


This randomized controlled trial will be conducted with a total of 81 participants diagnosed with PCOS. The participants will be randomly divided into 3 treatment groups: group A will receive SWJQD combined with acupuncture; group B, SWJQD combined with sham acupuncture; and group C, metformin. Each treatment will last 3 months. The primary outcomes include the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) index and the Oral Glucose Tolerance Test. The secondary outcome measures include sex hormone levels, body mass index, ovulation rate, clinical pregnancy rate, and complete genome sequencing data. Adverse events will be recorded during the intervention and follow-up.
RESULTS


This study will investigate whether the combination of SWJQD and acupuncture can alleviate the clinical symptoms and improve insulin resistance in patients with PCOS. The results of this study are expected to provide clinical evidence for the application of the combination of SWJQD and acupuncture in patients with PCOS.
TRIAL REGISTRATION


Chinese Clinical Trial Registry: ChiCTR1900028106, ChiMCT1900002826 (registered on December 12, 2019).",2020,The primary outcomes include the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) index and the Oral Glucose Tolerance Test.,"['Polycystic Ovarian Syndrome with kidney deficiency, phlegm and blood stasisness', 'patients with PCOS', '81 participants diagnosed with PCOS']","['SWJQD and acupuncture', 'Traditional Chinese medicine', 'Shouwu Jiangqi Decoction (SWJQD', 'Acupuncture', 'Shou-Wu Jiang-Qi Decoction combined acupuncture', 'SWJQD combined with acupuncture', 'SWJQD combined with sham acupuncture; and group C, metformin']","['Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) index and the Oral Glucose Tolerance Test', 'Adverse events', 'efficacy and safety', 'insulin resistance', 'sex hormone levels, body mass index, ovulation rate, clinical pregnancy rate, and complete genome sequencing data']","[{'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0225378', 'cui_str': 'Upper respiratory tract mucus (substance)'}, {'cui': 'C0005768'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0025124', 'cui_str': 'Zhong Yi Xue'}, {'cui': 'C4310132', 'cui_str': 'shouwu jiangqi'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0036884', 'cui_str': 'Gonadal Steroid Hormones'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C3640076', 'cui_str': 'Complete Genome Sequencing'}]",81.0,0.164609,The primary outcomes include the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) index and the Oral Glucose Tolerance Test.,"[{'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Reproduction, Zhangjiagang TCM Hospital Affiliated to Nanjing University of Chinese Medicine, Zhangjiagang, Suzhou, Jiangsu, China.'}, {'ForeName': 'Mengyu', 'Initials': 'M', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'Jiahui', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000019045']
542,32195934,Development and validation of a driving simulator for evaluating the residual effects of drugs on driving performance - sensitivity analysis using zopiclone as a positive control: Study Protocol Clinical Trial (SPIRIT Compliant).,"INTRODUCTION


Drugs acting on the central nervous system (CNS), especially hypnotics, can impair driving. The US Food and Drug Administration started requiring pharmaceutical companies to evaluate the residual influence of CNS agents on driving performance to review their recommended doses. Although it is important for physicians to discuss automobile driving while on medication with patients to promote traffic safety, the package inserts of most CNS agents in Japan uniformly prohibit patients from driving. Although more evidence-based information regarding the effects of drugs on driving performance is needed, the current evaluation methods for driving performance abroad cannot be applied directly to Japanese drivers because of differences in traffic environments, laws, and constitutions. Therefore, we plan to establish a new driving simulator (DS) that would enable the next-day residual effects of drugs on driving performance to be examined.
METHODS


In this double-blind, randomized, placebo-controlled, crossover trial, we plan to recruit 26 healthy Japanese males aged 21 to 64 years through advertisements. During the test periods, which will take place twice every other week, the participants will undergo a DS evaluation in the hospital for 2 days/1 night after the first and last doses of the study drug following 8 days of administration. The participants in the study drug group will take zopiclone 7.5 mg at bedtime on the first and eighth days in the hospital, and placebo on the other days. The DS evaluation consists of road tracking, car following, and harsh braking tests. The primary outcome is the standard deviation of lateral position (SDLP), which is a gold standard evaluation item, in the 60-min road-tracking test. The exploratory outcomes are other evaluation items in the DS tests, in the Karolinska Sleepiness Scale sleep questionnaire, and the Profile of Mood States Second Edition rating scale. The estimated difference in the SDLP between the zopiclone and placebo groups will then be calculated.
TRIAL REGISTRATION


This study was registered at ClinicalTrials.gov NCT04108351, on September 30, 2019. Ethics approval was obtained from the Ethics Committee at Hakata Clinic and the Nagoya University Medical School Hospital Bioethics Review Committee.",2020,The US Food and Drug Administration started requiring pharmaceutical companies to evaluate the residual influence of CNS agents on driving performance to review their recommended doses.,['26 healthy Japanese males aged 21 to 64 years through advertisements'],"['new driving simulator (DS', 'zopiclone 7.5\u200amg at bedtime', 'placebo']","['Karolinska Sleepiness Scale sleep questionnaire, and the Profile of Mood States Second Edition rating scale', 'SDLP', 'standard deviation of lateral position (SDLP), which is a gold standard evaluation item, in the 60-min road-tracking test']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C1128536', 'cui_str': 'zopiclone 7.5 MG'}, {'cui': 'C0521112', 'cui_str': 'Bedtime (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0222045'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states (assessment scale)'}, {'cui': 'C0441795', 'cui_str': 'Second edition (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0444379', 'cui_str': 'Lateral decubitus position (finding)'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0442650', 'cui_str': 'Road (environment)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",,0.113785,The US Food and Drug Administration started requiring pharmaceutical companies to evaluate the residual influence of CNS agents on driving performance to review their recommended doses.,"[{'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Iwata', 'Affiliation': 'Department of Psychiatry, Nagoya University, Graduate School of Medicine, Nagoya, Aichi.'}, {'ForeName': 'Kunihiro', 'Initials': 'K', 'LastName': 'Iwamoto', 'Affiliation': 'Department of Psychiatry, Nagoya University, Graduate School of Medicine, Nagoya, Aichi.'}, {'ForeName': 'Daiji', 'Initials': 'D', 'LastName': 'Kambe', 'Affiliation': 'Development Planning, Taisho Pharmaceutical Co., Ltd., Tokyo.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Tachibana', 'Affiliation': 'Development Planning, Taisho Pharmaceutical Co., Ltd., Tokyo.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, Nagoya, Aichi, Japan.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Ozaki', 'Affiliation': 'Department of Psychiatry, Nagoya University, Graduate School of Medicine, Nagoya, Aichi.'}]",Medicine,['10.1097/MD.0000000000019395']
543,32195937,Physical Exercise following bariatric surgery in women with Morbid obesity: Study protocol clinical trial (SPIRIT compliant).,"BACKGROUND


Severe and morbid obesity are increasing globally, particularly in women. As BMI increases, the likelihood of anovulation is higher. The primary aim of the EMOVAR clinical trial is to examine, over the short (16 weeks) and medium (12 months) term, the effects of a supervised physical exercise program (focused primarily on aerobic and resistance training) on ovarian function in women with severe/morbid obesity who have undergone bariatric surgery. Secondary objectives are to examine the effects of the intervention on chronic inflammation, insulin resistance, arterial stiffness, physical fitness, and health-related quality of life.
METHODS


This is a randomized controlled trial in which ∼40 female bariatric surgery patients, aged between 18 and 45 years old, will be included. Participants assigned to the experimental group will perform a total of 48 sessions of supervised concurrent (strength and aerobic) training (3 sessions/week, 60 min/session) spread over 16 weeks. Patients assigned to the control group will receive lifestyle recommendations. Outcomes will be assessed at baseline, week 16 (i.e., after the exercise intervention) and 12 months after surgery. The primary outcome is ovarian function using the Sex-Hormone Binding Globuline, measured in serum. Secondary outcomes are serum levels of anti-mullerian hormone, TSH, T4, FSH, LH, estradiol, prolactine, and free androgen index, as well as oocyte count, the diameters of both ovaries, endometrial thickness, and uterine arterial pulsatility index (obtained from a transvaginal ultrasound), the duration of menstrual bleeding and menstrual cycle duration (obtained by personal interview) and hirsutism (Ferriman Gallwey Scale). Other secondary outcomes include serum markers of chronic inflammation and insulin resistance (i.e., C-reactive protein, interleukin 6, tumor necrosis factor-alpha, leptin, glomerular sedimentation rate, glucose, insulin and the HOMA-IR), arterial stiffness, systolic, diastolic and mean blood pressure, body composition, and total weight loss. Physical fitness (including cardiorespiratory fitness, muscular strength, and flexibility), health-related quality of life (SF-36 v2) and sexual function (Female Sexual Function Index) will also be measured.
DISCUSSION


This study will provide, for the first time, relevant information on the effects of exercise training on ovarian function and underlying mechanisms in severe/morbid obese women following bariatric surgery.
TRIAL REGISTRATION NUMBER


ISRCTN registry (ISRCTN27697878).",2020,"Secondary outcomes are serum levels of anti-mullerian hormone, TSH, T4, FSH, LH, estradiol, prolactine, and free androgen index, as well as oocyte count, the diameters of both ovaries, endometrial thickness, and uterine arterial pulsatility index (obtained from a transvaginal ultrasound), the duration of menstrual bleeding and menstrual cycle duration (obtained by personal interview) and hirsutism (Ferriman Gallwey Scale).","['women with Morbid obesity', 'severe/morbid obese women following bariatric surgery', 'women with severe/morbid obesity who have undergone bariatric surgery', '∼40 female bariatric surgery patients, aged between 18 and 45 years old, will be included']","['bariatric surgery', 'supervised concurrent (strength and aerobic) training', 'supervised physical exercise program (focused primarily on aerobic and resistance training', 'control group will receive lifestyle recommendations', 'exercise training', 'Physical Exercise']","['Physical fitness (including cardiorespiratory fitness, muscular strength, and flexibility), health-related quality of life (SF-36 v2) and sexual function (Female Sexual Function Index', 'ovarian function', 'chronic inflammation, insulin resistance, arterial stiffness, physical fitness, and health-related quality of life', 'serum markers of chronic inflammation and insulin resistance (i.e., C-reactive protein, interleukin 6, tumor necrosis factor-alpha, leptin, glomerular sedimentation rate, glucose, insulin and the HOMA-IR), arterial stiffness, systolic, diastolic and mean blood pressure, body composition, and total weight loss', 'serum levels of anti-mullerian hormone, TSH, T4, FSH, LH, estradiol, prolactine, and free androgen index, as well as oocyte count, the diameters of both ovaries, endometrial thickness, and uterine arterial pulsatility index (obtained from a transvaginal ultrasound), the duration of menstrual bleeding and menstrual cycle duration (obtained by personal interview) and hirsutism (Ferriman Gallwey Scale', 'ovarian function using the Sex-Hormone Binding Globuline, measured in serum']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0028756', 'cui_str': 'Obesity, Severe'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0021376', 'cui_str': 'Chronic inflammatory reaction'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0162491', 'cui_str': 'Serum Markers'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0066928', 'cui_str': 'Anti-Muellerian Hormone'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C0428629', 'cui_str': 'Free androgen index measurement'}, {'cui': 'C0029045', 'cui_str': 'Ovocytes'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0227898', 'cui_str': 'Both ovaries (body structure)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4553712', 'cui_str': 'Onset of menstrual cycle'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0019572', 'cui_str': 'Hirsutism'}, {'cui': 'C0222045'}, {'cui': 'C0036884', 'cui_str': 'Gonadal Steroid Hormones'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.122253,"Secondary outcomes are serum levels of anti-mullerian hormone, TSH, T4, FSH, LH, estradiol, prolactine, and free androgen index, as well as oocyte count, the diameters of both ovaries, endometrial thickness, and uterine arterial pulsatility index (obtained from a transvaginal ultrasound), the duration of menstrual bleeding and menstrual cycle duration (obtained by personal interview) and hirsutism (Ferriman Gallwey Scale).","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Soriano-Maldonado', 'Affiliation': 'Department of Education, Faculty of Education Sciences.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Martínez-Forte', 'Affiliation': 'Obstetrics and Gynecology Unit, Torrecárdenas University Hospital, Almería.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ferrer-Márquez', 'Affiliation': 'Bariatric Surgery Department, Torrecárdenas University Hospital, Almería.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Martínez-Rosales', 'Affiliation': 'Department of Education, Faculty of Education Sciences.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Hernández-Martínez', 'Affiliation': 'Department of Education, Faculty of Education Sciences.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Carretero-Ruiz', 'Affiliation': 'Department of Education, Faculty of Education Sciences.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Villa-González', 'Affiliation': 'Department of Physical and Sports Education, PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Faculty of Education and Sport Sciences, University of Granada, Melilla.'}, {'ForeName': 'Yaira', 'Initials': 'Y', 'LastName': 'Barranco-Ruiz', 'Affiliation': 'Department of Physical and Sports Education, PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Faculty of Education and Sport Sciences, University of Granada, Melilla.'}, {'ForeName': 'Manuel A', 'Initials': 'MA', 'LastName': 'Rodríguez-Pérez', 'Affiliation': 'Department of Education, Faculty of Education Sciences.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Torrente-Sánchez', 'Affiliation': 'Obesidad Almería, Hospital Mediterráneo, Almería.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Carmona-Rodríguez', 'Affiliation': 'Department of Macromolecular Structures, Proteomics Unit, Centro Nacional de Biotecnología (CNB/CSIC).'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Soriano-Maldonado', 'Affiliation': 'Structural Biology Program, Spanish National Cancer Research Centre (CNIO), Madrid.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Vargas-Hitos', 'Affiliation': 'Systemic Autoimmune Diseases Unit, Department of Internal Medicine, ""Virgen de las Nieves"" University Hospital, Granada, Spain.'}, {'ForeName': 'Antonio J', 'Initials': 'AJ', 'LastName': 'Casimiro-Andújar', 'Affiliation': 'Department of Education, Faculty of Education Sciences.'}, {'ForeName': 'Enrique G', 'Initials': 'EG', 'LastName': 'Artero', 'Affiliation': 'Department of Education, Faculty of Education Sciences.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Fernández-Alonso', 'Affiliation': 'Obstetrics and Gynecology Unit, Torrecárdenas University Hospital, Almería.'}]",Medicine,['10.1097/MD.0000000000019427']
544,31455099,Self-reported emotional eating is not related to greater food intake: results from two laboratory studies.,"Objective : Despite widespread use of emotional eating self-report measures, the validity of these measures has been questioned. Most of this research has focused on the validity of the Dutch Eating Behavior Questionnaire (DEBQ) as opposed to the Emotional Eating Scale (EES). The current paper describes two experimental studies that examined associations between self-reported emotional eating and emotional eating measured in the laboratory. To address previous design limitations, the current studies used highly palatable foods, effective mood induction methods, and the EES, in addition to the DEBQ.  Design : In two samples of college students, participants were randomised to a neutral or negative mood induction.  Main Outcome Measures : The traditional DEBQ and the original and revised versions of the EES were used to measure self-reported emotional eating. Emotional eating was assessed in the laboratory using a bogus taste test. Subjects were asked to taste various foods, and food intake was measured.  Results : In both samples, self-reported emotional eating using the DEBQ and EES was unrelated to laboratory measured emotional eating (i.e. food consumed during the bogus taste test).  Conclusion : Future research in this area would benefit from using diverse samples and development of novel methods of assessing emotional eating.",2020,"In both samples, self-reported emotional eating using the DEBQ and EES was unrelated to laboratory measured emotional eating (i.e. food consumed during the bogus taste test).  ",['two samples of college students'],['neutral or negative mood induction'],"['Emotional eating', 'emotional eating and emotional eating', 'Dutch Eating Behavior Questionnaire (DEBQ']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0329618,"In both samples, self-reported emotional eating using the DEBQ and EES was unrelated to laboratory measured emotional eating (i.e. food consumed during the bogus taste test).  ","[{'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Braden', 'Affiliation': 'Bowling Green State University, Bowling Green, OH, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Emley', 'Affiliation': 'Bowling Green State University, Bowling Green, OH, USA.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Watford', 'Affiliation': 'Bowling Green State University, Bowling Green, OH, USA.'}, {'ForeName': 'LaNaya', 'Initials': 'L', 'LastName': 'Anderson', 'Affiliation': 'Bowling Green State University, Bowling Green, OH, USA.'}, {'ForeName': 'Dara', 'Initials': 'D', 'LastName': 'Musher-Eizenman', 'Affiliation': 'Bowling Green State University, Bowling Green, OH, USA.'}]",Psychology & health,['10.1080/08870446.2019.1649406']
545,31621423,A theory-based intervention delivered by an online social media platform to promote oral health among Iranian adolescents: a cluster randomized controlled trial.,"Objective:  Based on the Health Action Process Approach, we tested the efficacy of a theory-based program using an online social media platform (Telegram) to promote good oral hygiene behaviour among Iranian adolescents. Design:  A three-arm randomized-controlled trial design was used, consisting of an adolescent only intervention group (A group;  n  = 253), an adolescent and mother intervention group (A + M group;  n  = 260), and a control group ( n  = 278). Main outcome measures:  Psychosocial variables, toothbrushing behaviour, Visual Plaque Index, and Community Periodontal Index. Results:  Increases in adolescent toothbrushing at the one- and six-month follow-ups in both intervention groups compared to the control group were observed. Adolescents in the A + M group showed significant greater improvements in their toothbrushing behaviour, Visual Plaque Index, and Community Periodontal Index scores than adolescents in the A group. Improvements to toothbrushing social cognitions were also observed. Conclusions : Current results support the use of the theory-based program delivered by Telegram in improving good oral hygiene behaviour and oral health outcomes among Iranian adolescents. Involving mothers in an intervention can confer additional benefits for adolescent oral health.",2020,"Adolescents in the A + M group showed significant greater improvements in their toothbrushing behaviour, Visual Plaque Index, and Community Periodontal Index scores than adolescents in the A group.",['Iranian adolescents'],"['adolescent and mother intervention group (A\u2009+\u2009M group;  n \u2009=\u2009260), and a control group', 'theory-based program using an online social media platform (Telegram', 'online social media platform']","['toothbrushing behaviour, Visual Plaque Index, and Community Periodontal Index scores', 'good oral hygiene behaviour and oral health outcomes', 'toothbrushing social cognitions', 'Psychosocial variables, toothbrushing behaviour, Visual Plaque Index, and Community Periodontal Index']","[{'cui': 'C0554962', 'cui_str': 'Iranian (NMO) (ethnic group)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C3179065', 'cui_str': 'Social Media'}]","[{'cui': 'C0040461', 'cui_str': 'Toothbrushing'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0031092', 'cui_str': 'Periodontal Index'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0457639', 'cui_str': 'Good oral hygiene (finding)'}, {'cui': 'C0029162'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}]",278.0,0.0287629,"Adolescents in the A + M group showed significant greater improvements in their toothbrushing behaviour, Visual Plaque Index, and Community Periodontal Index scores than adolescents in the A group.","[{'ForeName': 'Janneke Francisca Maria', 'Initials': 'JFM', 'LastName': 'Scheerman', 'Affiliation': 'Department Oral Hygiene, Inholland University of Applied Sciences, Cluster Health, Sport and Welfare, Amsterdam, The Netherlands.'}, {'ForeName': 'Kyra', 'Initials': 'K', 'LastName': 'Hamilton', 'Affiliation': 'School of Applied Psychology, Griffith University, Brisbane, Australia.'}, {'ForeName': 'Mohammad Owaise', 'Initials': 'MO', 'LastName': 'Sharif', 'Affiliation': 'Eastman Dental Institute, University College London, London, England.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Lindmark', 'Affiliation': 'Department of Natural Science and Biomedicine, Centre for Oral Health, School of Health and Welfare, Jönköping University, Jönköping, Sweden.'}, {'ForeName': 'Amir H', 'Initials': 'AH', 'LastName': 'Pakpour', 'Affiliation': 'Social Determinants of Health Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran.'}]",Psychology & health,['10.1080/08870446.2019.1673895']
546,30922733,"Capecitabine compared with observation in resected biliary tract cancer (BILCAP): a randomised, controlled, multicentre, phase 3 study.","BACKGROUND


Despite improvements in multidisciplinary management, patients with biliary tract cancer have a poor outcome. Only 20% of patients are eligible for surgical resection with curative intent, with 5-year overall survival of less than 10% for all patients. To our knowledge, no studies have described a benefit of adjuvant therapy. We aimed to determine whether adjuvant capecitabine improved overall survival compared with observation following surgery for biliary tract cancer.
METHODS


This randomised, controlled, multicentre, phase 3 study was done across 44 specialist hepatopancreatobiliary centres in the UK. Eligible patients were aged 18 years or older and had histologically confirmed cholangiocarcinoma or muscle-invasive gallbladder cancer who had undergone a macroscopically complete resection (which includes liver resection, pancreatic resection, or, less commonly, both) with curative intent, and an Eastern Cooperative Oncology Group performance status of less than 2. Patients who had not completely recovered from previous surgery or who had previous chemotherapy or radiotherapy for biliary tract cancer were also excluded. Patients were randomly assigned 1:1 to receive oral capecitabine (1250 mg/m 2  twice daily on days 1-14 of a 21-day cycle, for eight cycles) or observation commencing within 16 weeks of surgery. Treatment was not masked, and allocation concealment was achieved with a computerised minimisation algorithm that stratified patients by surgical centre, site of disease, resection status, and performance status. The primary outcome was overall survival. As prespecified, analyses were done by intention to treat and per protocol. This study is registered with EudraCT, number 2005-003318-13.
FINDINGS


Between March 15, 2006, and Dec 4, 2014, 447 patients were enrolled; 223 patients with biliary tract cancer resected with curative intent were randomly assigned to the capecitabine group and 224 to the observation group. The data cutoff for this analysis was March 6, 2017. The median follow-up for all patients was 60 months (IQR 37-60). In the intention-to-treat analysis, median overall survival was 51·1 months (95% CI 34·6-59·1) in the capecitabine group compared with 36·4 months (29·7-44·5) in the observation group (adjusted hazard ratio [HR] 0·81, 95% CI 0·63-1·04; p=0·097). In a protocol-specified sensitivity analysis, adjusting for minimisation factors and nodal status, grade, and gender, the overall survival HR was 0·71 (95% CI 0·55-0·92; p=0·010). In the prespecified per-protocol analysis (210 patients in the capecitabine group and 220 in the observation group), median overall survival was 53 months (95% CI 40 to not reached) in the capecitabine group and 36 months (30-44) in the observation group (adjusted HR 0·75, 95% CI 0·58-0·97; p=0·028). In the intention-to-treat analysis, median recurrence-free survival was 24·4 months (95% CI 18·6-35·9) in the capecitabine group and 17·5 months (12·0-23·8) in the observation group. In the per-protocol analysis, median recurrence-free survival was 25·9 months (95% CI 19·8-46·3) in the capecitabine group and 17·4 months (12·0-23·7) in the observation group. Adverse events were measured in the capecitabine group only, and of the 213 patients who received at least one cycle, 94 (44%) had at least one grade 3 toxicity, the most frequent of which were hand-foot syndrome in 43 (20%) patients, diarrhoea in 16 (8%) patients, and fatigue in 16 (8%) patients. One (<1%) patient had grade 4 cardiac ischaemia or infarction. Serious adverse events were observed in 47 (21%) of 223 patients in the capecitabine group and 22 (10%) of 224 patients in the observation group. No deaths were deemed to be treatment related.
INTERPRETATION


Although this study did not meet its primary endpoint of improving overall survival in the intention-to-treat population, the prespecified sensitivity and per-protocol analyses suggest that capecitabine can improve overall survival in patients with resected biliary tract cancer when used as adjuvant chemotherapy following surgery and could be considered as standard of care. Furthermore, the safety profile is manageable, supporting the use of capecitabine in this setting.
FUNDING


Cancer Research UK and Roche.",2019,"No deaths were deemed to be treatment related.
","['patients with resected biliary tract cancer', 'patients with biliary tract cancer', 'resected biliary tract cancer (BILCAP', '44 specialist hepatopancreatobiliary centres in the UK', 'Between March 15, 2006, and Dec 4, 2014, 447 patients were enrolled; 223 patients with biliary tract cancer resected with curative intent', 'Eligible patients were aged 18 years or older and had histologically confirmed cholangiocarcinoma or muscle-invasive gallbladder cancer who had undergone a macroscopically complete resection (which includes liver resection, pancreatic resection, or, less commonly, both) with curative intent, and an Eastern Cooperative Oncology Group performance status of less than 2', 'Patients who had not completely recovered from previous surgery or who had previous chemotherapy or radiotherapy for biliary tract cancer', 'registered with EudraCT, number 2005-003318-13']","['capecitabine', 'Capecitabine', 'oral capecitabine ', 'adjuvant capecitabine']","['Adverse events', '5-year overall survival', 'diarrhoea', 'grade 4 cardiac ischaemia or infarction', 'median overall survival', 'grade 3 toxicity', 'overall survival', 'median recurrence-free survival', 'Serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750952', 'cui_str': 'Biliary Tract Cancer'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocellular Carcinoma'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0153452', 'cui_str': 'Cancer of Gallbladder'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0854522', 'cui_str': 'Pancreatic resection'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C4554154', 'cui_str': 'Completely - dosing instruction fragment (qualifier value)'}, {'cui': 'C0521108', 'cui_str': 'Recovering from (contextual qualifier) (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}]",447.0,0.426977,"No deaths were deemed to be treatment related.
","[{'ForeName': 'John N', 'Initials': 'JN', 'LastName': 'Primrose', 'Affiliation': 'Department of Surgery, University of Southampton, Southampton, UK. Electronic address: j.n.primrose@soton.ac.uk.'}, {'ForeName': 'Richard P', 'Initials': 'RP', 'LastName': 'Fox', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Palmer', 'Affiliation': 'University of Liverpool and Clatterbridge Cancer Centre, Liverpool, UK.'}, {'ForeName': 'Hassan Z', 'Initials': 'HZ', 'LastName': 'Malik', 'Affiliation': 'Aintree University Hospital, Liverpool, UK.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Prasad', 'Affiliation': 'Department of Surgery, University of Leeds, Leeds, UK.'}, {'ForeName': 'Darius', 'Initials': 'D', 'LastName': 'Mirza', 'Affiliation': ""University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK; Women's Children's Hospital NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Anthony', 'Affiliation': 'Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Pippa', 'Initials': 'P', 'LastName': 'Corrie', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Falk', 'Affiliation': 'University of Bristol Hospitals NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Finch-Jones', 'Affiliation': 'University of Bristol Hospitals NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Harpreet', 'Initials': 'H', 'LastName': 'Wasan', 'Affiliation': 'Imperial Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ross', 'Affiliation': ""Guys and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Wall', 'Affiliation': 'Lothian University Hospitals NHS Trust, Edinburgh, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Wadsley', 'Affiliation': 'Weston Park Hospital, Sheffield, UK.'}, {'ForeName': 'Jeff T R', 'Initials': 'JTR', 'LastName': 'Evans', 'Affiliation': 'Department of Oncology, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Stocken', 'Affiliation': 'Faculty of Medicine and Health, University of Leeds, Leeds, UK.'}, {'ForeName': 'Raaj', 'Initials': 'R', 'LastName': 'Praseedom', 'Affiliation': 'Addenbrookes Hospital, Cambridge, UK.'}, {'ForeName': 'Yuk Ting', 'Initials': 'YT', 'LastName': 'Ma', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Davidson', 'Affiliation': 'Department of General Surgery, University College London Hospital, London, UK.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Neoptolemos', 'Affiliation': 'Department of Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Iveson', 'Affiliation': 'University Hospitals Southampton, Southampton, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Raftery', 'Affiliation': 'Health Economics Analysis Team, University of Southampton, Southampton, UK.'}, {'ForeName': 'Shihua', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': 'Health Economics Analysis Team, University of Southampton, Southampton, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'Royal Marsden NHS Trust, London, UK.'}, {'ForeName': 'O James', 'Initials': 'OJ', 'LastName': 'Garden', 'Affiliation': 'Department of Medicine, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Stubbs', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Juan W', 'Initials': 'JW', 'LastName': 'Valle', 'Affiliation': 'University of Manchester and The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bridgewater', 'Affiliation': 'UCL Cancer Institute, University College London, London, UK. Electronic address: j.bridgewater@ucl.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(18)30915-X']
547,32195927,Impact of mobile phone text messaging intervention on adherence among patients with diabetes in a rural setting: A randomized controlled trial.,"BACKGROUND


Nonadherence to prescribed therapy is a significant challenge at the primary healthcare level of South Africa. There are documented evidence of the potential impact of mobile health technology in improving adherence and compliance to treatment. This study assessed the effect of unidirectional text messaging on adherence to dietary and activity regimens among adults living with diabetes in a rural setting of Eastern Cape, South Africa.
METHODS


This was a 2-arm, multicenter, parallel, randomized controlled trial, involving a total of 216 patients with diabetes with uncontrolled glycemic status randomly assigned into the intervention (n = 108) and the control group (n = 108). Participants in the intervention arm received daily educational text messages on diabetes and reminders for 6 months, while the control arm continued with standard care only. A validated, self-developed adherence scale was used to assess participants' adherence to diets and physical activity. Descriptive statistics and linear regression were used to assess changes in adherence and the effect of the intervention on adherence to therapy.
RESULTS


On a scale of 8, the mean medication adherence level for the intervention group was 6.90 (SD ± 1.34) while that of the control group was 6.87 (SD ± 1.32) with no statistical difference (P = .88). The adjusted mean change in the medication adherence level was 0.02 (-0.33 to 0.43) with no significant difference (P = .79). There was however a low level of adherence to dietary recommendations (1.52 ± 1.62), and physical activity (1.48 ± 1.58) at baseline, and both groups demonstrated a nonsignificant increase in dietary (P = .98) and physical activity adherence (P = .99) from baseline to the follow-up period.
CONCLUSION


There is a moderate level of adherence to medication and a low level of adherence to dietary and physical activity recommendation in this setting. The text messaging intervention did not bring about any significant improvement in medication, dietary and physical activity adherence levels. There is a need to design effective strategies for improving adherence to recommended lifestyle changes in this setting.",2020,The adjusted mean change in the medication adherence level was 0.02,"['adults living with diabetes in a rural setting of Eastern Cape, South Africa', 'patients with diabetes in a rural setting', '216 patients with diabetes with uncontrolled glycemic status randomly assigned into the intervention (n\u200a=\u200a108) and the control group (n\u200a=\u200a108']","['mobile phone text messaging intervention', 'daily educational text messages on diabetes and reminders for 6 months, while the control arm continued with standard care only', 'unidirectional text messaging']","['mean medication adherence level', 'physical activity', 'medication adherence level', 'medication, dietary and physical activity adherence levels', 'low level of adherence to dietary recommendations', 'physical activity adherence']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0453952', 'cui_str': 'Cape (physical object)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",216.0,0.0910297,The adjusted mean change in the medication adherence level was 0.02,"[{'ForeName': 'Eyitayo Omolara', 'Initials': 'EO', 'LastName': 'Owolabi', 'Affiliation': 'Department of Nursing Science, Faculty of Health Sciences, University of Fort Hare, East London, South Africa.'}, {'ForeName': 'Daniel Ter', 'Initials': 'DT', 'LastName': 'Goon', 'Affiliation': 'Department of Nursing Science, Faculty of Health Sciences, University of Fort Hare, East London, South Africa.'}, {'ForeName': 'Anthony Idowu', 'Initials': 'AI', 'LastName': 'Ajayi', 'Affiliation': 'Population Dynamics and Reproductive Health Unit, African Population and Health Research Centre, APHRC Campus, Nairobi, Kenya.'}]",Medicine,['10.1097/MD.0000000000018953']
548,31216027,How Much Is Needed? Comparison of the Effectiveness of Different Pain Education Dosages in Patients with Fibromyalgia.,"OBJECTIVE


To assess the effect of different dosages of pain neuroscience education (PNE) programs on central nociceptive processing in patients with fibromyalgia. Second, to compare the effects of different dosages of PNE programs on numerical pain rating scale (NPRS), disability, and psychological variables.
DESIGN


Single-blind randomized controlled trial.
SETTING


Three fibromyalgia centers in Spain (Valencia, Alcorcón, Alcalá de Henares).
SUBJECTS


Seventy-seven patients with fibromyalgia.
METHODS


Participants were randomized to four groups of PNE: 1) high-dose PNE (N = 20), 2) low-concentrated dose PNE (N = 20), 3) diluted low-dose PNE (N = 20), and (4) control treatment (N = 17), conducted in two 30-50-minute sessions in groups of four to six participants. Conditioned pain modulation (CPM), temporal summation (TS), and pressure pain thresholds (PPTs) were assessed at baseline and at three-month follow-up. Secondary outcome measures were the Fibromyalgia Impact Questionnaire, Pain Catastrophizing Scale, and Pain Anxiety Symptoms Scale.
RESULTS


There were significant between-group differences for NPRS in favor of the groups receiving high-dose PNE, with a large effect size at three-month follow-up (P < 0.01, η2p = 0.170), but there were no significant differences between groups for the remaining variables (P > 0.05). All groups improved for central nociceptive processing, psychological variables, disability, and pain intensity (NPRS).
CONCLUSIONS


In patients with fibromyalgia, higher dosages of PNE produced a larger improvement in pain severity at three-month follow-up than other dosages of PNE and biomedical education. However, PNE was not superior to biomedical education in the central nociceptive processing, disability, or psychological variables in patients with fibromyalgia.",2020,"Secondary outcome measures were the Fibromyalgia Impact Questionnaire, Pain Catastrophizing Scale, and Pain Anxiety Symptoms Scale.
","['Patients with Fibromyalgia', 'Seventy-seven patients with fibromyalgia', 'Three fibromyalgia centers in Spain (Valencia, Alcorcón, Alcalá de Henares', 'Participants', 'patients with fibromyalgia']","['Pain Education', 'PNE', 'PNE programs', 'PNE: 1) high-dose PNE (N\u2009=\u200920), 2) low-concentrated dose PNE (N\u2009=\u200920), 3) diluted low-dose PNE', 'pain neuroscience education (PNE) programs']","['Fibromyalgia Impact Questionnaire, Pain Catastrophizing Scale, and Pain Anxiety Symptoms Scale', 'Conditioned pain modulation (CPM), temporal summation (TS), and pressure pain thresholds (PPTs', 'central nociceptive processing, psychological variables, disability, and pain intensity (NPRS', 'NPRS', 'central nociceptive processing', 'numerical pain rating scale (NPRS), disability, and psychological variables', 'pain severity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C3266592', 'cui_str': 'Pain education'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}]","[{'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0222045'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation, function (observable entity)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",77.0,0.0689158,"Secondary outcome measures were the Fibromyalgia Impact Questionnaire, Pain Catastrophizing Scale, and Pain Anxiety Symptoms Scale.
","[{'ForeName': 'Juan J', 'Initials': 'JJ', 'LastName': 'Amer-Cuenca', 'Affiliation': 'Department of Physiotherapy, Universidad Cardenal Herrera-CEU, CEU Universities, Valencia, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pecos-Martín', 'Affiliation': 'Department of Nursing and Physiotheraphy, Universidad de Alcalá, Alcalá de Henares, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Martínez-Merinero', 'Affiliation': 'Department of Nursing and Physiotheraphy, Universidad de Alcalá, Alcalá de Henares, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Lluch Girbés', 'Affiliation': 'Department of Physiotherapy, Universitat de València, Valencia, Spain.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Nijs', 'Affiliation': 'Pain in Motion International Research Group, www.paininmotion.be.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Meeus', 'Affiliation': 'Pain in Motion International Research Group, www.paininmotion.be.'}, {'ForeName': 'Raúl', 'Initials': 'R', 'LastName': 'Ferrer Peña', 'Affiliation': 'Physical Therapy Department and Motion in Brains Research Group, Instituto de Neurociencias y Ciencias del Movimiento (INCIMOV), Centro Superior de Estudios Universitarios La Salle, Universidad Aut\U000adbada de Madrid, Spain.'}, {'ForeName': 'Josué', 'Initials': 'J', 'LastName': 'Fernández-Carnero', 'Affiliation': 'Physical Therapy Department and Motion in Brains Research Group, Instituto de Neurociencias y Ciencias del Movimiento (INCIMOV), Centro Superior de Estudios Universitarios La Salle, Universidad Aut\U000adbada de Madrid, Spain.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz069']
549,31277077,Cardiorespiratory behavior of preterm infants receiving continuous positive airway pressure and high flow nasal cannula post extubation: randomized crossover study.,"BACKGROUND


Nasal continuous positive airway pressure (NCPAP) and high flow nasal cannula (HFNC) are modes of non-invasive respiratory support commonly used after extubation in extremely preterm infants. However, the cardiorespiratory physiology of these infants on each mode is unknown.
METHODS


Prospective, randomized crossover study in infants with birth weight ≤1250 g undergoing their first extubation attempt. NCPAP and HFNC were applied randomly for 45 min each, while ribcage and abdominal movements, electrocardiogram, oxygen saturation, and fraction of inspired oxygen (FiO 2 ) were recorded. Respiratory signals were analyzed using an automated method, and differences between NCPAP and HFNC features and changes in FiO 2  were analyzed.
RESULTS


A total of 30 infants with median [interquartile range] gestational age of 27 weeks [25.7, 27.9] and birth weight of 930 g [780, 1090] were studied. Infants were extubated at 5 days [2, 13] of life with 973 g [880, 1170] and three failed (10%). No differences in cardiorespiratory behavior were noted, except for longer respiratory pauses (9.2 s [5.0, 11.5] vs. 7.3 s [4.6, 9.3]; p = 0.04) and higher FiO 2  levels (p = 0.02) during HFNC compared to NCPAP.
CONCLUSIONS


In extremely preterm infants studied shortly after extubation, the use of HFNC was associated with longer respiratory pauses and higher FiO 2  requirements.",2020,"No differences in cardiorespiratory behavior were noted, except for longer respiratory pauses (9.2 s [5.0, 11.5] vs. 7.3 s [4.6, 9.3]; p = 0.04) and higher FiO 2  levels (p = 0.02) during HFNC compared to NCPAP.
","['extremely preterm infants', 'infants with birth weight ≤1250', 'preterm infants receiving continuous positive airway pressure and high flow nasal cannula post extubation', '30 infants with median [interquartile range] gestational age of 27 weeks [25.7, 27.9] and birth weight of 930\u2009g [780, 1090']","['HFNC', 'NCPAP and HFNC', 'Nasal continuous positive airway pressure (NCPAP) and high flow nasal cannula (HFNC']","['longer respiratory pauses', 'ribcage and abdominal movements, electrocardiogram, oxygen saturation, and fraction of inspired oxygen (FiO 2 ', 'cardiorespiratory behavior']","[{'cui': 'C3494262', 'cui_str': 'Extremely Preterm Infants'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1258045', 'cui_str': 'Nasal Continuous Positive Airway Pressure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0222762', 'cui_str': 'Thoracic Cage'}, {'cui': 'C1286159', 'cui_str': 'Movement of abdomen'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",30.0,0.118465,"No differences in cardiorespiratory behavior were noted, except for longer respiratory pauses (9.2 s [5.0, 11.5] vs. 7.3 s [4.6, 9.3]; p = 0.04) and higher FiO 2  levels (p = 0.02) during HFNC compared to NCPAP.
","[{'ForeName': 'Lara J', 'Initials': 'LJ', 'LastName': 'Kanbar', 'Affiliation': 'Department of Biomedical Engineering, Montreal, QC, Canada.'}, {'ForeName': 'Wissam', 'Initials': 'W', 'LastName': 'Shalish', 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Latremouille', 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada.'}, {'ForeName': 'Smita', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Brown', 'Affiliation': 'Department of Anesthesia, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Kearney', 'Affiliation': 'Department of Biomedical Engineering, Montreal, QC, Canada.'}, {'ForeName': 'Guilherme M', 'Initials': 'GM', 'LastName': ""Sant'Anna"", 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada. guilherme.santanna@mcgill.ca.'}]",Pediatric research,['10.1038/s41390-019-0494-5']
550,31283409,"Neoadjuvant Three-Dimensional Conformal Radiotherapy for Resectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus: A Randomized, Open-Label, Multicenter Controlled Study.","PURPOSE


To compare the survival outcomes of neoadjuvant three-dimensional conformal radiotherapy (RT) followed by hepatectomy with hepatectomy alone in patients with hepatocellular carcinoma (HCC) and portal vein tumor thrombus (PVTT).
PATIENTS AND METHODS


A randomized, multicenter controlled study was conducted from January 2016 to December 2017 in patients with resectable HCC and PVTT. Patients were randomly assigned to receive neoadjuvant RT followed by hepatectomy (n = 82) or hepatectomy alone (n = 82). The modified Response Evaluation Criteria in Solid Tumors (mRECIST) guidelines were used to evaluate the therapeutic effects of RT. The primary end point was overall survival. The expression of interleukin-6 (IL-6) in patients' serum before RT and in surgical specimens was correlated with response to RT.
RESULTS


In the neoadjuvant RT group, 17 patients (20.7%) had partial remission. The overall survival rates for the neoadjuvant RT group at 6, 12, 18, and 24 months were 89.0%, 75.2%, 43.9%, and 27.4%, respectively, compared with 81.7%, 43.1%, 16.7%, and 9.4% in the surgery-alone group ( P  < .001). The corresponding disease-free survival rates were 56.9%, 33.0%, 20.3%, and 13.3% versus 42.1%, 14.9%, 5.0%, and 3.3% ( P  < .001). On multivariable Cox regression analyses, neoadjuvant RT significantly reduced HCC-related mortality and HCC recurrence rates compared with surgery alone (hazard ratios, 0.35 [95% CI, 0.23 to 0.54;  P  < .001] and 0.45 [95% CI, 0.31 to 0.64;  P  < .001]). Increased expressions of IL-6 in pre-RT serum and tumor tissues were significantly associated with resistance to RT.
CONCLUSION


For patients with resectable HCC and PVTT, neoadjuvant RT provided significantly better postoperative survival outcomes than surgery alone. IL-6 may predict response to RT in these patients.",2019,"The expression of interleukin-6 (IL-6) in patients' serum before RT and in surgical specimens was correlated with response to RT.
","['Resectable Hepatocellular Carcinoma', 'January 2016 to December 2017 in patients with resectable HCC and PVTT', 'patients with hepatocellular carcinoma (HCC) and portal vein tumor thrombus (PVTT', 'With Portal Vein Tumor Thrombus']","['neoadjuvant RT followed by hepatectomy', 'PVTT', 'hepatectomy alone', 'hepatectomy with hepatectomy alone', 'IL-6', 'neoadjuvant three-dimensional conformal radiotherapy (RT', 'Neoadjuvant Three-Dimensional Conformal Radiotherapy']","['partial remission', 'expression of interleukin-6 (IL-6', 'corresponding disease-free survival rates', 'survival outcomes', 'Increased expressions of IL-6 in pre-RT serum and tumor tissues', 'overall survival rates', 'HCC-related mortality and HCC recurrence rates', 'postoperative survival outcomes', 'overall survival']","[{'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032718', 'cui_str': 'Portal Vein'}, {'cui': 'C3163918', 'cui_str': 'Tumor thrombus'}]","[{'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0600521', 'cui_str': 'Three-Dimensional Conformal Radiotherapy'}]","[{'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample (specimen)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",,0.0761295,"The expression of interleukin-6 (IL-6) in patients' serum before RT and in surgical specimens was correlated with response to RT.
","[{'ForeName': 'Xubiao', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': ""1Eastern Hepatobiliary Surgery Hospital, Navy Military Medical University, Shanghai, People's Republic of China.""}, {'ForeName': 'Yabo', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': ""1Eastern Hepatobiliary Surgery Hospital, Navy Military Medical University, Shanghai, People's Republic of China.""}, {'ForeName': 'Xiuping', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""1Eastern Hepatobiliary Surgery Hospital, Navy Military Medical University, Shanghai, People's Republic of China.""}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Feng', 'Affiliation': ""1Eastern Hepatobiliary Surgery Hospital, Navy Military Medical University, Shanghai, People's Republic of China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': ""1Eastern Hepatobiliary Surgery Hospital, Navy Military Medical University, Shanghai, People's Republic of China.""}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Ye', 'Affiliation': ""2Department of Health Statistics, Navy Military Medical University, Shanghai, People's Republic of China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Xing', 'Affiliation': ""1Eastern Hepatobiliary Surgery Hospital, Navy Military Medical University, Shanghai, People's Republic of China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ""1Eastern Hepatobiliary Surgery Hospital, Navy Military Medical University, Shanghai, People's Republic of China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': ""1Eastern Hepatobiliary Surgery Hospital, Navy Military Medical University, Shanghai, People's Republic of China.""}, {'ForeName': 'Weixing', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': ""1Eastern Hepatobiliary Surgery Hospital, Navy Military Medical University, Shanghai, People's Republic of China.""}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': ""3Fujian Provincial Cancer Hospital, Fuzhou, People's Republic of China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""3Fujian Provincial Cancer Hospital, Fuzhou, People's Republic of China.""}, {'ForeName': 'Huichuan', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': ""4Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': ""4Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Congde', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': ""1Eastern Hepatobiliary Surgery Hospital, Navy Military Medical University, Shanghai, People's Republic of China.""}, {'ForeName': 'Yaxin', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': ""1Eastern Hepatobiliary Surgery Hospital, Navy Military Medical University, Shanghai, People's Republic of China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Meng', 'Affiliation': ""1Eastern Hepatobiliary Surgery Hospital, Navy Military Medical University, Shanghai, People's Republic of China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Huang', 'Affiliation': ""1Eastern Hepatobiliary Surgery Hospital, Navy Military Medical University, Shanghai, People's Republic of China.""}, {'ForeName': 'Wenming', 'Initials': 'W', 'LastName': 'Cong', 'Affiliation': ""1Eastern Hepatobiliary Surgery Hospital, Navy Military Medical University, Shanghai, People's Republic of China.""}, {'ForeName': 'Wan Yee', 'Initials': 'WY', 'LastName': 'Lau', 'Affiliation': ""1Eastern Hepatobiliary Surgery Hospital, Navy Military Medical University, Shanghai, People's Republic of China.""}, {'ForeName': 'Shuqun', 'Initials': 'S', 'LastName': 'Cheng', 'Affiliation': ""1Eastern Hepatobiliary Surgery Hospital, Navy Military Medical University, Shanghai, People's Republic of China.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02184']
551,32267032,Systemic and muscular responses to effort-matched short intervals and long intervals in elite cyclists.,"The purpose of this study was to compare the acute effects of time- and effort-matched high-intensity intervals on physiological, endocrine, and skeletal muscle molecular variables in elite cyclists. Eight elite cyclists performed short intervals (SI: 30-seconds) and long intervals (LI: 5-minutes) with work:recovery ratio 2:1, using a randomized crossover design. SI was associated with 14% ± 3% higher mean power output (SI; 421 ± 27 vs LI; 371 ± 22 W), and longer working time above 90% of maximal oxygen uptake (VO 2max  , 54% ± 76%) and 90% peak heart rate (HR peak  , 153% ± 148%) than LI (all P < .05), despite similar degrees of perceived exertion, blood lactate levels and muscle activation measured using EMG root mean square (EMG rms). In blood, SI was associated with more pronounced increases in testosterone and testosterone-to-sex hormone-binding globulin (SHBG) ratios, as well as prolonged cortisol responses (P < .05). In skeletal muscle (m. Vastus lateralis), SI and LI led to similar changes in mRNA abundance for a range of transcripts, with the exception of NHE1 mRNA, which decreased after SI (P < .05). Overall, SI was associated with more pronounced physiological and endocrine responses than LI in elite cyclists, suggesting that such training might lead to superior adaptations in elite cyclists.",2020,"In skeletal muscle (m. Vastus lateralis), SI and LI led to similar changes in mRNA abundance for a range of transcripts, with the exception of NHE1 mRNA, which decreased after SI (p<0.05).","['elite cyclists', 'Eight elite cyclists performed']","['time- and effort-matched high-intensity intervals', 'short intervals (SI: 30-s) and long intervals (LI: 5-min) with work:recovery ratio 2:1']","['Systemic and muscular responses', 'peak heart rate', 'longer working time', 'perceived exertion, blood lactate levels and muscle activation measured using EMG root mean square (EMG rms', 'testosterone and testosterone-to-sex-hormone-binding-globulin (SHBG) ratios']","[{'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0651677,"In skeletal muscle (m. Vastus lateralis), SI and LI led to similar changes in mRNA abundance for a range of transcripts, with the exception of NHE1 mRNA, which decreased after SI (p<0.05).","[{'ForeName': 'Nicki W', 'Initials': 'NW', 'LastName': 'Almquist', 'Affiliation': 'Section for Health and Exercise Physiology, Inland Norway University of Applied Sciences, Lillehammer, Norway.'}, {'ForeName': 'Håvard', 'Initials': 'H', 'LastName': 'Nygaard', 'Affiliation': 'Section for Health and Exercise Physiology, Inland Norway University of Applied Sciences, Lillehammer, Norway.'}, {'ForeName': 'Geir', 'Initials': 'G', 'LastName': 'Vegge', 'Affiliation': 'Section for Health and Exercise Physiology, Inland Norway University of Applied Sciences, Lillehammer, Norway.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hammarström', 'Affiliation': 'Section for Health and Exercise Physiology, Inland Norway University of Applied Sciences, Lillehammer, Norway.'}, {'ForeName': 'Stian', 'Initials': 'S', 'LastName': 'Ellefsen', 'Affiliation': 'Section for Health and Exercise Physiology, Inland Norway University of Applied Sciences, Lillehammer, Norway.'}, {'ForeName': 'Bent R', 'Initials': 'BR', 'LastName': 'Rønnestad', 'Affiliation': 'Section for Health and Exercise Physiology, Inland Norway University of Applied Sciences, Lillehammer, Norway.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13672']
552,30908574,"Paracetamol and Pain Modulation by TRPV1, UGT2B15, SULT1A1 Genotypes: A Randomized Clinical Trial in Healthy Volunteers.","BACKGROUND


The influence of the genetic polymorphism of enzymes and receptors involved in paracetamol metabolism and mechanism of action has not been investigated. This trial in healthy volunteers investigated the link between paracetamol pain relief and the genetic polymorphism of 23 enzymes and receptors.
DESIGN


This randomized double-blind crossover controlled pilot study took place in the Clinical Pharmacology Department, University Hospital, Clermont-Ferrand, France. Forty-seven Caucasian volunteers were recruited. The trial consisted of two randomized sessions one week apart with oral paracetamol or placebo, and pain changes were evaluated with mechanical pain stimuli. The genetic polymorphism of 23 enzymes and receptors was studied, and correlations were made with pain relief. All tests are two-sided with a type I error at 0.05.
RESULTS


Paracetamol was antinociceptive compared with placebo (222 ± 482 kPaxmin vs 23 ± 431 kPaxmin; P = 0.0047), and the study showed 30 paracetamol responders and 17 paracetamol nonresponders. Responders were characterized by TRPV1rs224534 A allele, UGT2B15rs1902023 TT genotype, and SULT1A1rs9282861 GG genotype (P < 0.05 for all). These findings confirm for the first time the involvement of a specific TRPV1 rs224534 variant in paracetamol antinociception. They also reveal a new antinociceptive role for specific variants of hepatic phase II enzymes associated with paracetamol metabolism.
CONCLUSIONS


The study warrants larger clinical trials on these potential genomic markers of paracetamol analgesia in patients. Confirmation of the present findings would open the way to effective individualized pain treatment with paracetamol, the most commonly used analgesic worldwide.",2020,"RESULTS


Paracetamol was antinociceptive compared with placebo (222 ± 482 kPaxmin vs 23 ± 431 kPaxmin; P = 0.0047), and the study showed 30 paracetamol responders and 17 paracetamol nonresponders.","['Healthy Volunteers', 'healthy volunteers', 'Forty-seven Caucasian volunteers', 'patients']","['paracetamol analgesia', 'paracetamol', 'oral paracetamol or placebo', 'placebo']",['pain relief'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}]",47.0,0.266732,"RESULTS


Paracetamol was antinociceptive compared with placebo (222 ± 482 kPaxmin vs 23 ± 431 kPaxmin; P = 0.0047), and the study showed 30 paracetamol responders and 17 paracetamol nonresponders.","[{'ForeName': 'Gisèle', 'Initials': 'G', 'LastName': 'Pickering', 'Affiliation': 'Faculty of Medicine Inserm 1107, Clinical Pharmacology Centre, CPC/CIC Inserm 1405 University Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Creveaux', 'Affiliation': 'Molecular Biology Department, Faculty of Medicine, University Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Macian', 'Affiliation': 'Faculty of Medicine Inserm 1107, Clinical Pharmacology Centre, CPC/CIC Inserm 1405 University Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'Direction Recherche Clinique, Biostatistics Unit, CHU Clermont-Ferrand, Clermont-Ferrand, France.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz037']
553,30911113,"Short telomeres are associated with inferior outcome, genomic complexity, and clonal evolution in chronic lymphocytic leukemia.","Telomere length in chronic lymphocytic leukemia (CLL) has been shown to be of prognostic importance, but the analyses have largely been executed on heterogeneous patient cohorts outside of clinical trials. In the present study, we performed a comprehensive analysis of telomere length associations in the well characterized CLL8 trial (n = 620) of the German CLL study group, with validation in a representative cohort of the CLL4 trial (n = 293). Absolute telomere length was analyzed using quantitative-PCR. Apart from identifying associations of short telomere length with adverse prognostic factors and survival, the study identified cases with 17p- and 11q- associated with TP53 and ATM loss, respectively, to have the shortest telomeres, even when these aberrations were present in small subclones. Thus, telomere shortening may precede acquisition of the high-risk aberrations, contributing to disease evolution. In line with this, telomere shortening was associated with an increase in genomic complexity as well as clonal evolution, highlighting its importance as a biomarker especially in monitoring disease progression in non-high-risk CLL.",2019,"In line with this, telomere shortening was associated with an increase in genomic complexity as well as clonal evolution, highlighting its importance as a biomarker especially in monitoring disease progression in non-high-risk CLL.","['well characterized CLL8 trial (n\u2009=\u2009620) of the German CLL study group, with validation in a representative cohort of the CLL4 trial (n\u2009=\u2009293', 'chronic lymphocytic leukemia (CLL', 'chronic lymphocytic leukemia']",[],"['TP53 and ATM loss', 'Absolute telomere length', 'genomic complexity']","[{'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C4708788', 'cui_str': '620'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],"[{'cui': 'C0678214', 'cui_str': 'atmosphere (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0085187'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0887950', 'cui_str': 'Genomics'}]",,0.0234911,"In line with this, telomere shortening was associated with an increase in genomic complexity as well as clonal evolution, highlighting its importance as a biomarker especially in monitoring disease progression in non-high-risk CLL.","[{'ForeName': 'Billy Michael Chelliah', 'Initials': 'BMC', 'LastName': 'Jebaraj', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Eugen', 'Initials': 'E', 'LastName': 'Tausch', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Dan A', 'Initials': 'DA', 'LastName': 'Landau', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Bahlo', 'Affiliation': 'Department I for Internal Medicine and Centre for Integrated Oncology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Robrecht', 'Affiliation': 'Department I for Internal Medicine and Centre for Integrated Oncology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Amaro N', 'Initials': 'AN', 'LastName': 'Taylor-Weiner', 'Affiliation': 'Broad Institute, Cambridge, MA, USA.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Bloehdorn', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Scheffold', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Mertens', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Böttcher', 'Affiliation': 'Department II of Internal Medicine, University Hospital of Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kneba', 'Affiliation': 'Department II of Internal Medicine, University Hospital of Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Jäger', 'Affiliation': 'Department of Medicine I, Division of Hematology and Hemostaeology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Zenz', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Wenger', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Guenter', 'Initials': 'G', 'LastName': 'Fingerle-Rowson', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Wendtner', 'Affiliation': 'Klinikum Schwabing, Academic Teaching Hospital of University of Munich, Munich, Germany.'}, {'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Fink', 'Affiliation': 'Department I for Internal Medicine and Centre for Integrated Oncology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Wu', 'Affiliation': 'Broad Institute, Cambridge, MA, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Eichhorst', 'Affiliation': 'Department I for Internal Medicine and Centre for Integrated Oncology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Fischer', 'Affiliation': 'Department I for Internal Medicine and Centre for Integrated Oncology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hallek', 'Affiliation': 'Department I for Internal Medicine and Centre for Integrated Oncology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Stilgenbauer', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany. stephan.stilgenbauer@uniklinik-ulm.de.'}]",Leukemia,['10.1038/s41375-019-0446-4']
554,31607172,Editor's choice: Optimizing healthy food preferences by serious gaming.,"Objective:  Serious gaming is an upcoming and promising tool in prevention and health promotion. The aim of this experimental study was to examine whether health-related serious gaming could optimize food-related outcomes and physical activity. Design:  Eighty-one healthy participants (80% female) were randomly allocated to an experimental condition, in which participants played serious games based on transferring information, priming and evaluative conditioning, for half an hour, or a control condition, in which participants played non-health-related computer games. Main outcome measures:  The primary study outcome was self-reported food preference and self-reported food choice, assessed by the Food Choice Task with food pairs differing in healthiness, or in both healthiness and attractiveness. Secondary outcomes were actual food choice and physical activity. Results:  A significantly healthier food preference for pairs differing in healthiness was found on the Food Choice Task in the experimental compared to the control condition. No significant differences were found on the other outcomes. Conclusions:  This study provides preliminary support for the effects of serious gaming based on optimizing food preferences. More research is needed to confirm the present findings and to further elucidate and optimize the effects of serious gaming on health behaviours.",2020,A significantly healthier food preference for pairs differing in healthiness was found on the Food Choice Task in the experimental compared to the control condition.,['Eighty-one healthy participants (80% female'],"['participants played serious games based on transferring information, priming and evaluative conditioning, for half an hour, or a control condition, in which participants played non-health-related computer games']","['self-reported food preference and self-reported food choice, assessed by the Food Choice Task with food pairs differing in healthiness, or in both healthiness and attractiveness', 'actual food choice and physical activity']","[{'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0870328', 'cui_str': 'Computer Games'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0016483', 'cui_str': 'Food Preferences'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",81.0,0.0314779,A significantly healthier food preference for pairs differing in healthiness was found on the Food Choice Task in the experimental compared to the control condition.,"[{'ForeName': 'Lemmy', 'Initials': 'L', 'LastName': 'Schakel', 'Affiliation': 'Faculty of Social and Behavioural Sciences, Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Dieuwke S', 'Initials': 'DS', 'LastName': 'Veldhuijzen', 'Affiliation': 'Faculty of Social and Behavioural Sciences, Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Meriem', 'Initials': 'M', 'LastName': 'Manai', 'Affiliation': 'Faculty of Social and Behavioural Sciences, Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Sylvia van', 'Initials': 'SV', 'LastName': 'Beugen', 'Affiliation': 'Faculty of Social and Behavioural Sciences, Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Rosalie van der', 'Initials': 'RV', 'LastName': 'Vaart', 'Affiliation': 'Faculty of Social and Behavioural Sciences, Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Henriët van', 'Initials': 'HV', 'LastName': 'Middendorp', 'Affiliation': 'Faculty of Social and Behavioural Sciences, Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Andrea W M', 'Initials': 'AWM', 'LastName': 'Evers', 'Affiliation': 'Faculty of Social and Behavioural Sciences, Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden University, Leiden, The Netherlands.'}]",Psychology & health,['10.1080/08870446.2019.1675657']
555,31420812,Platelet-rich plasma in treatment of patients with idiopathic carpal tunnel syndrome.,"BACKGROUND


Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy in the upper extremity. Treatments for CTS alternate from conservative strategies to surgical decompression of median nerve. Few studies have applied platelet-rich plasma (PRP) for treating idiopathic CTS, with acceptable success rates. Further studies are needed to reach concrete conclusion.
OBJECTIVE


To study the effect of PRP injection in treatment of mild to moderate idiopathic CTS.
METHODS


This is a randomized controlled trial in a cohort of Egyptian patients suffered from mild to moderate CTS. They were randomly divided into two groups. Group 1: patients received ultrasound guided PRP injection and group 2 patients received ultrasound guided corticosteroid injection. The outcome measures were assessed via Visual Analog Scale, the Boston Carpal Tunnel Syndrome Questionnaire, electrophysiological findings in sensory and motor functions of median nerve and morphological changes of median nerve detected by ultrasound.
RESULTS


This study included 150 patients suffered from mild to moderate idiopathic CTS 15 did not provide the written consent and 37 participants were excluded from the study based on the exclusion criteria leaving only 98 patients to participate in the study they were divided into two groups PRP Injection Group (PRP-inj-G) - this group included 49 patients (40 females and 9 males) steroid injection Group (St-inj-G) - included 49 patients (41 females and 8 males). At the beginning of study there was no significant difference between both groups in all parameters. (a) PRP injection had significantly improved the clinical manifestations, the electrodiagnostic examination (EDX) parameters of the median nerve (MN), and the median nerve cross sectional area (m-CSA) at 1 month and 3 months post-injection evaluation in comparison to baseline recordings; (b) local steroid injection had significantly improved the clinical manifestations, the EDX parameters of the MN, and the m-CSA at 1 month and 3 months post-injection evaluation in comparison to baseline recordings and (c) PRP injection was superior to the local steroid injection in the improvement of clinical manifestations as well as the MN motor conduction velocity along the wrist-elbow segment, the sensory latency (SL) and the MN sensory conduction, this superiority was observed in third month follow-up suggesting better outcomes in long-term follow-up.
CONCLUSION


Platelet-rich plasma could be effective treatment of mild to moderate idiopathic CTS and superior to corticosteroid in improving pain, function, and distal sensory latency of median nerve.
TRIAL REGISTRATION


Clinical Trials.gov Identifier: NCT03863873Key Points:• PRP is effective treatment of mild to moderate CTS.• PRP is superior to corticosteroids in improving pain and function in CTS.",2019,At the beginning of study there was no significant difference between both groups in all parameters.,"['patients with idiopathic carpal tunnel syndrome', '150 patients suffered from mild to moderate idiopathic CTS 15 did not provide the written consent and 37 participants were excluded from the study based on the exclusion criteria leaving only 98 patients to participate in the study they', 'Egyptian patients suffered from mild to moderate CTS', 'Carpal tunnel syndrome (CTS', 'included 49 patients (40 females and 9 males', 'mild to moderate idiopathic CTS', 'included 49 patients (41 females and 8 males']","['Platelet-rich plasma', 'corticosteroids', 'steroid injection Group (St-inj-G) ', 'PRP', 'PRP Injection Group (PRP-inj-G) - this group', 'PRP injection', 'ultrasound guided PRP injection', 'ultrasound guided corticosteroid injection']","['clinical manifestations, the electrodiagnostic examination (EDX) parameters of the median nerve (MN), and the median nerve cross sectional area (m-CSA', 'pain, function, and distal sensory latency of median nerve', 'sensory latency (SL) and the MN sensory conduction', 'pain and function in CTS', 'via Visual Analog Scale, the Boston Carpal Tunnel Syndrome Questionnaire, electrophysiological findings in sensory and motor functions of median nerve and morphological changes of median nerve detected by ultrasound']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0007286', 'cui_str': 'Amyotrophy, Thenar, Of Carpal Origin'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0337801', 'cui_str': 'Egyptians (ethnic group)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0025058', 'cui_str': 'Median Nerve'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0457405', 'cui_str': 'Conduction (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0007286', 'cui_str': 'Amyotrophy, Thenar, Of Carpal Origin'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}]",150.0,0.0187617,At the beginning of study there was no significant difference between both groups in all parameters.,"[{'ForeName': 'Mohammad K', 'Initials': 'MK', 'LastName': 'Senna', 'Affiliation': 'Faculty of Medicine, Department of Rheumatology and Rehabilitation, Mansoura University, Elgomhoria St., Mansoura, Egypt.'}, {'ForeName': 'Reham M', 'Initials': 'RM', 'LastName': 'Shaat', 'Affiliation': 'Faculty of Medicine, Department of Rheumatology and Rehabilitation, Mansoura University, Elgomhoria St., Mansoura, Egypt. rehamshaat@mans.edu.eg.'}, {'ForeName': 'Alaa Ali Awad', 'Initials': 'AAA', 'LastName': 'Ali', 'Affiliation': 'Faculty of Medicine, Department of Rheumatology and Rehabilitation, Mansoura University, Elgomhoria St., Mansoura, Egypt.'}]",Clinical rheumatology,['10.1007/s10067-019-04719-7']
556,32251792,The Efficacy and Safety of High-dose Daptomycin in the Treatment of Complicated Skin and Soft Tissue Infections in Asians.,"OBJECTIVE


To compare the efficacy and safety of standard-dose (SD) daptomycin with those of high-dose (HD) daptomycin in complicated skin and soft tissue infections (cSSTIs) in an Asian population.
MATERIALS AND METHODS


Patients from three medical centers diagnosed with cSSTIs were screened in the clinical information system. Patients included in the analysis were divided into two groups: those who received daptomycin at doses ≥ 6 mg/kg (HD group) and those receiving 4 mg/kg (SD group). The demographics and clinical treatment information were analyzed.
RESULTS


Overall, 155 patients were recruited, including 108 patients in the SD group and 47 patients in the HD group. The rate of healthcare-associated infections was higher in the HD group (61.70% vs. 37.04%), demonstrating a statistically significant difference (P = 0.005). Compared with the SD group, the HD group had statistically significant early clinical stabilization (72.34% vs 52.78%, P = 0.023). The results of the multivariate analysis indicated that HD daptomycin was an independent effector for early clinical stabilization (HR=0.394, P < 0.001). The rate of drug-related adverse events was equally distributed in the HD and SD groups (36.17% vs. 26.85%, P = 0.243).
CONCLUSION


Compared with SD daptomycin, HD daptomycin increased the rate of early clinical stabilization in Asian patients with cSSTIs, whereas the incidence of adverse events did not increase.",2020,"The rate of healthcare-associated infections was higher in the HD group (61.70% vs. 37.04%), demonstrating a statistically significant difference (P = 0.005).","['complicated skin and soft tissue infections (cSSTIs) in an Asian population', '155 patients were recruited, including 108 patients in the SD group and 47 patients in the HD group', 'Patients from three medical centers diagnosed with cSSTIs were screened in the clinical information system', 'Complicated Skin and Soft Tissue Infections in Asians']","['daptomycin at doses ≥ 6\u2009mg/kg (HD group) and those receiving 4\u2009mg/kg (SD group', 'High-dose Daptomycin', 'standard-dose (SD) daptomycin with those of high-dose (HD) daptomycin']","['clinical stabilization', 'rate of early clinical stabilization', 'incidence of adverse events', 'rate of drug-related adverse events', 'rate of healthcare-associated infections', 'efficacy and safety']","[{'cui': 'C4727978', 'cui_str': 'Complicated skin and soft tissue infection'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021428', 'cui_str': 'Information system'}]","[{'cui': 'C0057144', 'cui_str': 'Daptomycin'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",155.0,0.0449794,"The rate of healthcare-associated infections was higher in the HD group (61.70% vs. 37.04%), demonstrating a statistically significant difference (P = 0.005).","[{'ForeName': 'Xiao-Meng', 'Initials': 'XM', 'LastName': 'Dong', 'Affiliation': 'Department of Infectious Diseases, Qilu Hospital of Shandong University, Jinan 250012, China.'}, {'ForeName': 'Nan-Nan', 'Initials': 'NN', 'LastName': 'Xu', 'Affiliation': 'Department of Infectious Diseases, Qilu Hospital of Shandong University, Jinan 250012, China.'}, {'ForeName': 'Yong-Yuan', 'Initials': 'YY', 'LastName': 'Yao', 'Affiliation': ""Department of Intensive Care Medicine, Rizhao People's Hospital, Rizhao 276800, China.""}, {'ForeName': 'Yan-Yan', 'Initials': 'YY', 'LastName': 'Guan', 'Affiliation': ""Department of Infectious Diseases, Rizhao People's Hospital, Rizhao 276800, China.""}, {'ForeName': 'Qing-Yan', 'Initials': 'QY', 'LastName': 'Li', 'Affiliation': ""Department of Infectious Diseases, Liaocheng People's Hospital, Liaocheng 252000, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zheng', 'Affiliation': 'Department of Infectious Diseases, Qilu Hospital of Shandong University, Jinan 250012, China.'}, {'ForeName': 'Feng-Zhe', 'Initials': 'FZ', 'LastName': 'Chen', 'Affiliation': 'Department of Infectious Diseases, Qilu Hospital of Shandong University, Jinan 250012, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Infectious Diseases, Qilu Hospital of Shandong University, Jinan 250012, China. Electronic address: clinicalpaper@163.com.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.03.060']
557,32254027,Safety and efficacy of tranexamic acid with epinephrine for prevention of blood loss following surgery for trochanteric femoral fractures.,"OBJECTIVE


This study aimed to determine whether the local administration of tranexamic acid (TXA) combined with diluted epinephrine (DEP) reduces blood loss and the need for transfusions compared with the administration of TXA alone following surgery for trochanteric femoral fractures.
METHODS


Hundred patients were enrolled in this study. In the target group (TXA/DEP group: n=50; 19 men and 31 women, mean age 72.5±11.1 years), the surgical sites were injected with 35 mL normal saline mixed with 3 g of TXA with 0.2 mg of DEP at a 1:200,000 dilution (TXA/DEP) immediately after musculoaponeurotic closure. In the control group (TXA group: n=50; 22 men and 28 women; mean age: 70.5±12.2 years), the surgical site was injected with 35 mL normal saline containing 3 g of TXA alone. The main outcome measures were postoperative hemoglobin (Hb) levels, hematocrit, drainage volume, and total blood loss (TBL); the secondary measures included transfusion requirements and perioperative complications.
RESULTS


The mean Hb levels among patients in theTXA/DEP group were significantly lower than among those in the TXA group, measured on postoperative day 1 at 101.0±14.1 g/L vs. 106.9±10.5 g/L and day 3 as 104.2±8.2 g/L vs. 108.5±9.1 g/L, respectively (p<0.05). Drainage volume from the surgical site and TBL measured on postoperative day 2 were also significantly reduced in the TXA/DEP group vs. the TXA group, measured at 71.4±26.0 mL vs. 82.5±24.6 mL and 343.6±148.0 mL vs. 419.6±165.4 mL, respectively (p<0.05). Furthermore, 11 patients (22%) from the TXA group and 15 (30%) from the TXA/DEP group received blood transfusions; the mean number of transfusion events (1.2±0.4 vs. 1.9±0.7) and the amount of blood transfused (1.7±0.5 Units vs. 2.9±1.0 Units) was also markedly reduced in the TXA/DEP group (p<0.05). Two cases in the TXA/DEP group and three in the TXA group were diagnosed with deep vein thrombosis, a difference that did not reach statistical significance (p>0.05).
CONCLUSION


Local administration of TXA with DEP reduced blood loss and limited the need for blood transfusions after surgery for trochanteric femoral fracture without increasing the risk of perioperative complications. Our study indicates that the local administration of TXA/DEP is safe and more effective than the administration of TXA alone in treating trochanteric femoral fractures.
LEVEL OF EVIDENCE


Level III, Therapeutic study.",2020,Local administration of TXA with DEP reduced blood loss and limited the need for blood transfusions after surgery for trochanteric femoral fracture without increasing the risk of perioperative complications.,"['n=50; 19 men and 31 women, mean age 72.5±11.1 years), the surgical sites', 'surgery for trochanteric femoral fractures', 'Hundred patients were enrolled in this study', 'group: n=50; 22 men and 28 women; mean age: 70.5±12.2 years']","['35 mL normal saline mixed with 3 g of TXA with 0.2 mg of DEP at a 1:200,000 dilution (TXA/DEP', 'control group (TXA', '35 mL normal saline containing 3 g of TXA alone', 'TXA/DEP', 'TXA', 'tranexamic acid (TXA) combined with diluted epinephrine (DEP', 'theTXA/DEP', 'TXA with DEP', 'tranexamic acid with epinephrine']","['postoperative hemoglobin (Hb) levels, hematocrit, drainage volume, and total blood loss (TBL); the secondary measures included transfusion requirements and perioperative complications', 'mean Hb levels', 'blood transfusions; the mean number of transfusion events', 'blood loss', 'amount of blood transfused', 'deep vein thrombosis', 'Drainage volume']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332850', 'cui_str': 'Operative site'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C2363779', 'cui_str': 'Trochanteric femoral fracture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0057472', 'cui_str': '1-(2-(dodecyloxy)ethyl)pyrrolidine hydrochloride'}, {'cui': 'C0079240', 'cui_str': 'Dilution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}]",0.0,0.0742255,Local administration of TXA with DEP reduced blood loss and limited the need for blood transfusions after surgery for trochanteric femoral fracture without increasing the risk of perioperative complications.,"[{'ForeName': 'Xinxian', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""Department of Osteopathy, the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, China.""}, {'ForeName': 'Linghui', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'Department of Radiology, Wenzhou Seventh Hospital, Wenzhou, China.'}, {'ForeName': 'Huachen', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': ""Department of Osteopathy, the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, China.""}, {'ForeName': 'Yuezheng', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': ""Department of Osteopathy, the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, China.""}]",Acta orthopaedica et traumatologica turcica,['10.5152/j.aott.2020.02.135']
558,32101426,Lowering Urinary Phthalate Metabolite Concentrations among Children by Reducing Contaminated Dust in Housing Units: A Randomized Controlled Trial and Observational Study.,"Dust in homes can contain phthalates that may adversely affect child development, but whether residential interventions and dust removal can prevent children's exposure to phthalates is unknown. We quantified the influence of a residential lead hazard intervention and dust control on children's urinary phthalate metabolite concentrations. Between 2003 and 2006, The Health Outcomes and Measures of the Environment (HOME) Study randomized 355 pregnant women to receive an intervention to reduce either residential lead or injury hazards before delivery. We quantified eight urinary phthalate metabolites from 288 children at ages 1, 2, or 3 years (680 observations). During yearly home visits, we assessed dust accumulation in housing units. Children in the lead intervention group had 11-12% lower concentrations of the sum of di(2-ethylhexyl) phthalate metabolites, monocarboxyoctyl phthalate, and monocarboxynonyl phthalate compared to the injury intervention group. Monoethyl phthalate concentrations did not differ by group. In observational analyses, children living in housing units that appeared clean had 12-17% lower concentrations of these phthalate metabolites and monobenzyl phthalate, compared to children living in housing units with more dust accumulation. Features of this lead hazard intervention and measures to control dust may reduce children's exposure to phthalates found in building materials and household furnishings.",2020,"Children in the lead intervention group had 11-12% lower concentrations of the sum of di(2-ethylhexyl) phthalate metabolites, monocarboxyoctyl phthalate, and monocarboxynonyl phthalate compared to the injury intervention group.","['355 pregnant women to receive an', ""children's urinary phthalate metabolite concentrations"", '288 children at ages 1, 2, or 3 years (680 observations', 'children by reducing contaminated dust in housing units']","['residential lead hazard intervention and dust control', 'intervention to reduce either residential lead or injury hazards before delivery']","['Health Outcomes and Measures of the Environment', 'concentrations of the sum of di(2-ethylhexyl) phthalate metabolites, monocarboxyoctyl phthalate, and monocarboxynonyl phthalate', 'Monoethyl phthalate concentrations']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0220894', 'cui_str': 'phthalate'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205279', 'cui_str': 'Contaminated (qualifier value)'}, {'cui': 'C0013330', 'cui_str': 'Dust'}, {'cui': 'C0020056', 'cui_str': 'Housing'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0013330', 'cui_str': 'Dust'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0220894', 'cui_str': 'phthalate'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C3659034', 'cui_str': 'monoethyl phthalate'}]",355.0,0.0726831,"Children in the lead intervention group had 11-12% lower concentrations of the sum of di(2-ethylhexyl) phthalate metabolites, monocarboxyoctyl phthalate, and monocarboxynonyl phthalate compared to the injury intervention group.","[{'ForeName': 'Clara G', 'Initials': 'CG', 'LastName': 'Sears', 'Affiliation': 'Department of Epidemiology, Brown University, Providence, Rhode Island 02912, United States.'}, {'ForeName': 'Bruce P', 'Initials': 'BP', 'LastName': 'Lanphear', 'Affiliation': 'Faculty of Health Sciences, Simon Fraser University, Burnaby, BC V5A 1S6, Canada.'}, {'ForeName': 'Antonia M', 'Initials': 'AM', 'LastName': 'Calafat', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia 30329, United States.'}, {'ForeName': 'Aimin', 'Initials': 'A', 'LastName': 'Chen', 'Affiliation': 'Department of Environmental Health, University of Cincinnati College of Medicine, Cincinnati, Ohio 45267, United States.'}, {'ForeName': 'Julianne', 'Initials': 'J', 'LastName': 'Skarha', 'Affiliation': 'Department of Epidemiology, Brown University, Providence, Rhode Island 02912, United States.'}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ""Division of General and Community Pediatrics, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio 45267, United States.""}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Yolton', 'Affiliation': ""Department of Pediatrics, Division of General and Community Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229, United States.""}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Braun', 'Affiliation': 'Department of Epidemiology, Brown University, Providence, Rhode Island 02912, United States.'}]",Environmental science & technology,['10.1021/acs.est.9b04898']
559,32249441,The effect of platelet-rich plasma as a scaffold in regeneration/revitalization endodontics of immature permanent teeth assessed using 2-dimensional radiographs and cone beam computed tomography: a randomized controlled trial.,"AIM


To assess the outcomes of platelet-rich plasma as a scaffold in regenerative/revitalization endodontics (RET) using cone beam computed tomography (CBCT) and 2-dimensional radiographs.
METHODOLOGY


Twenty-six healthy patients with mean age of 12.66 ± 4.47, and immature permanent anterior teeth with necrotic pulps, were randomly allocated to two groups, whereby RET was performed using platelet-rich plasma (PRP, test group) and blood clot (BLC, control group). Changes in root length (RL), root dentinal thickness (RDT), apical foramen width (AFW) and radiographic root area (RRA), were assessed using both radiographic methods, whilst changes in periapical area diameter (PAD) were assessed using CBCT, over a period of 12 months. T-test and chi-square/Fisher's exact tests were used to compare continuous and categorical data between BLC and PRP groups, respectively. Changes in RL, RDT, AFW, RRA and PAD were examined by comparing the two groups (PRP versus BLC) using multilevel modelling, considering the clustering effect of repeated measures of several teeth originating from the same participant.
RESULTS


Changes in RL, RDT, AFW, RRA and PAD, over time, were found to be significant for both groups. There was, however, no difference between the RET techniques (PRP versus BLC), using both radiographic and CBCT methods. The results of both assessment techniques (CBCT and 2-dimensional radiographic methods) were highly consistent (overall ICC ranged between 0.80 and 0.94). In addition, a significant effect of baseline PAD was found on RL, RRA and AD at 12 months (RL effect = -0.68, P < 0.001; RRA effect = -1.91, P = 0.025; AD effect = 0.08, P = 0.024).
CONCLUSION


The current study highlights successful and comparable clinical and radiographic outcomes of RET techniques using PRP and BLC. Standardized and calibrated 2-dimensional radiographic assessment was as effective as CBCT in assessing RET outcomes; therefore, the routine use of CBCT in RET is not recommended. Although an effect of baseline periapical lesion diameter on root development outcomes, at 12 months, were observed, more studies are recommended in order to assess such an effect.",2020,"Changes in root length (RL), root dentinal thickness (RDT), apical foramen width (AFW), and radiographic root area (RRA), were assessed using both radiographic methods, while changes in periapical area diameter (PAD) was assessed using CBCT, over a period of 12 months.","['immature permanent anterior teeth with necrotic pulps', 'Twenty-six healthy patients with mean age of 12.66']","['Cone Beam Computed Tomography (CBCT', 'platelet rich plasma (PRP, test group) and blood clot (BLC, control group', 'platelet-rich plasma']","['RL, RDT, AFW, RRA and PAD', 'baseline PAD', 'Changes in RL, RDT, AFW, RRA, and PAD', 'periapical area diameter (PAD', 'Changes in root length (RL), root dentinal thickness (RDT), apical foramen width (AFW), and radiographic root area (RRA']","[{'cui': 'C0205252', 'cui_str': 'Immature'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0032027', 'cui_str': 'Pityriasis rubra pilaris'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0206743', 'cui_str': 'Malignant rhabdoid tumor'}, {'cui': 'C0034596', 'cui_str': 'Radioreceptor assay'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0729269', 'cui_str': 'Periapical'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0524789', 'cui_str': 'Structure of apical foramen of tooth'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}]",26.0,0.0509993,"Changes in root length (RL), root dentinal thickness (RDT), apical foramen width (AFW), and radiographic root area (RRA), were assessed using both radiographic methods, while changes in periapical area diameter (PAD) was assessed using CBCT, over a period of 12 months.","[{'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'ElSheshtawy', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Nazzal', 'Affiliation': 'Paediatric Dentistry Section, Hamad Dental Center, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'O I', 'Initials': 'OI', 'LastName': 'El Shahawy', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'El Baz', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Ismail', 'Affiliation': 'Department of Endodontics, The National Research Center, Cairo, Egypt.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'Department of Oral Biology, School of Dentistry, University of Leeds, Leeds, UK.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Ezzat', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}]",International endodontic journal,['10.1111/iej.13303']
560,32253227,Effectiveness of a lumbopelvic monitor and feedback device to change postural behaviour: the ELF cluster randomised controlled trial.,"OBJECTIVES


The aim of this clustered, randomised controlled trial was to assess the effectiveness of a lumbopelvic postural feedback device for changing postural behaviour in a group of healthcare workers. We hypothesised that workers exposed to auditory postural feedback would reduce the number of times forward bending posture is adopted at work.
METHODS


This was a participant and assessor blinded, randomised, sham-controlled trial with blocked cluster random allocation. We recruited healthcare workers from aged care institutions. Healthcare sites were randomly allocated to the feedback or sham group (SG). A postural monitoring and feedback device was used to monitor and record lumbopelvic forward bending posture, and provided audio feedback whenever the user sustained lumbopelvic forward bending posture that exceeded predefined thresholds. The primary outcome measure was postural behaviour (exceeding thresholds). We used a robust variant of repeated measures mixed-effect model for assessing within-group and between-group differences in postural behaviour.
RESULTS


We recruited 19 sites, and 130 healthcare workers participated. There were no within-group changes on the number of times postural threshold was exceeded at 1-week follow-up (feedback group: -0.7, 95% CI -2.61 to 0.72; SG -0.3, -1.65 to 0.98), and no differences (0.05, 95% CI -1.83 to 1.94) between SG and feedback group.
CONCLUSIONS


Findings from this trial indicate that audio feedback provided by a postural monitor device did not reduce the number of times healthcare workers exceeded the postural threshold.
TRIAL REGISTRATION NUMBER


ACTRN12616000449437.",2020,"There were no within-group changes on the number of times postural threshold was exceeded at 1-week follow-up (feedback group: -0.7, 95% CI -2.61 to 0.72; SG -0.3, -1.65 to 0.98), and no differences (0.05, 95% CI -1.83 to 1.94) between SG and feedback group.
","['We recruited 19 sites, and 130 healthcare workers participated', 'healthcare workers from aged care institutions', 'Healthcare sites', 'a group of healthcare workers']","['feedback or sham group (SG', 'lumbopelvic monitor and feedback device', 'lumbopelvic postural feedback device']","['number of times postural threshold', 'postural behaviour (exceeding thresholds', 'number of times healthcare workers']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205278', 'cui_str': 'Postural'}]","[{'cui': 'C0449809', 'cui_str': 'Number of times'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]",,0.253141,"There were no within-group changes on the number of times postural threshold was exceeded at 1-week follow-up (feedback group: -0.7, 95% CI -2.61 to 0.72; SG -0.3, -1.65 to 0.98), and no differences (0.05, 95% CI -1.83 to 1.94) between SG and feedback group.
","[{'ForeName': 'Daniel Cury', 'Initials': 'DC', 'LastName': 'Ribeiro', 'Affiliation': 'School of Physiotherapy, University of Otago, Dunedin, New Zealand daniel.ribeiro@otago.ac.nz.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Milosavljevic', 'Affiliation': 'School of Physiotherapy, College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Terry', 'Affiliation': 'School of Physiotherapy, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Abbott', 'Affiliation': 'Department of Surgical Sciences, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.'}]",Occupational and environmental medicine,['10.1136/oemed-2019-106293']
561,32253263,Effect of State Immunization Information System Centralized Reminder and Recall on HPV Vaccination Rates.,"BACKGROUND


Although autodialer centralized reminder and recall (C-R/R) from state immunization information systems (IISs) has been shown to raise childhood vaccination rates, its impact on human papillomavirus (HPV) vaccination rates is unclear.
METHODS


In a 4-arm pragmatic randomized controlled trial across 2 states, we randomly selected practices representative of the specialty (pediatrics, family medicine, and health center) where children received care. Within each practice, patients 11 to 17.9 years old who had not completed their HPV vaccine series (NY:  N  = 30 616 in 123 practices; CO:  N  = 31 502 in 80 practices) were randomly assigned to receive 0, 1, 2, or 3 IIS C-R/R autodialer messages per vaccine dose. We assessed HPV vaccine receipt via the IIS, calculated intervention costs, and compared HPV vaccine series initiation and completion rates across study arms.
RESULTS


In New York, HPV vaccine initiation rates ranged from 37.0% to 37.4%, and completion rates were between 29.1% and 30.1%, with no significant differences across study arms. In Colorado, HPV vaccine initiation rates ranged from 31.2% to 33.5% and were slightly higher for 1 reminder compared with none, but vaccine completion rates, ranging from 27.0% to 27.8%, were similar. On adjusted analyses in Colorado, vaccine initiation rates were slightly higher for 1 and 3 C-R/R messages (adjusted risk ratios 1.07 and 1.04, respectively); completion rates were slightly higher for 1 and 3 C-R/R messages (adjusted risk ratios 1.02 and 1.03, respectively).
CONCLUSIONS


IIS-based C-R/R for HPV vaccination did not improve HPV vaccination rates in New York and increased vaccination rates slightly in Colorado.",2020,"In Colorado, HPV vaccine initiation rates ranged from 31.2% to 33.5% and were slightly higher for 1 reminder compared with none, but vaccine completion rates, ranging from 27.0% to 27.8%, were similar.","['2 states, we randomly selected practices representative of the specialty (pediatrics, family medicine, and health center) where children received care', 'patients 11 to 17.9 years old who had not completed their HPV vaccine series (NY:  N  ', '30\u2009616 in 123 practices', 'N  = 31\u2009502 in 80 practices']",[],"['Colorado, vaccine initiation rates', 'completion rates', 'HPV vaccination rates', 'vaccination rates', 'HPV vaccine initiation rates', 'HPV Vaccination Rates']","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1444661', 'cui_str': 'Stopped before completion'}, {'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}, {'cui': 'C0205549', 'cui_str': 'Series'}]",[],"[{'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}]",,0.434936,"In Colorado, HPV vaccine initiation rates ranged from 31.2% to 33.5% and were slightly higher for 1 reminder compared with none, but vaccine completion rates, ranging from 27.0% to 27.8%, were similar.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Szilagyi', 'Affiliation': 'Department of Pediatrics, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California; pszilagyi@mednet.ucla.edu.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Albertin', 'Affiliation': 'Department of Pediatrics, School of Medicine and Dentistry, University of Rochester, Rochester, New York.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Gurfinkel', 'Affiliation': 'Adult and Child Consortium for Health Outcomes Research and Delivery Science, School of Medicine and.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Beaty', 'Affiliation': 'Adult and Child Consortium for Health Outcomes Research and Delivery Science, School of Medicine and.'}, {'ForeName': 'Xinkai', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Statistics Core and.'}, {'ForeName': 'Sitaram', 'Initials': 'S', 'LastName': 'Vangala', 'Affiliation': 'Statistics Core and.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rice', 'Affiliation': 'Adult and Child Consortium for Health Outcomes Research and Delivery Science, School of Medicine and.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Campbell', 'Affiliation': 'Clinical Pharmacy and.'}, {'ForeName': 'Melanie D', 'Initials': 'MD', 'LastName': 'Whittington', 'Affiliation': 'Clinical Pharmacy and.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Valderrama', 'Affiliation': 'Department of Pediatrics, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Breck', 'Affiliation': 'Department of Pediatrics, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Roth', 'Affiliation': 'Colorado Immunization Information System, Colorado Department of Public Health and Environment, Denver, Colorado.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Meldrum', 'Affiliation': 'New York State Immunization Information System, New York State Department of Health, Albany, New York; and.'}, {'ForeName': 'Chi-Hong', 'Initials': 'CH', 'LastName': 'Tseng', 'Affiliation': 'Statistics Core and.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Rand', 'Affiliation': 'Department of Pediatrics, School of Medicine and Dentistry, University of Rochester, Rochester, New York.'}, {'ForeName': 'Sharon G', 'Initials': 'SG', 'LastName': 'Humiston', 'Affiliation': ""Department of Pediatrics, Children's Mercy Hospital, Kansas City, Missouri.""}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Schaffer', 'Affiliation': 'Department of Pediatrics, School of Medicine and Dentistry, University of Rochester, Rochester, New York.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Kempe', 'Affiliation': 'Departments of Pediatrics and.'}]",Pediatrics,['10.1542/peds.2019-2689']
562,32149863,Learning mechanisms in nocebo hyperalgesia: the role of conditioning and extinction processes.,"Nocebo hyperalgesia is a clinically relevant phenomenon and may be formed as a result of associative learning, implemented by classical conditioning. This study explored for the first time distinct nocebo conditioning methods and their consequences for nocebo attenuation methods. Healthy participants (N = 140) were recruited and randomized to the following nocebo hyperalgesia induction groups: conditioning with continuous reinforcement (CRF), conditioning with partial reinforcement (PRF), and a sham-conditioning control group. In the attenuation phase, counterconditioning was compared with extinction. During induction, participants experienced increased thermal pain in 100% of nocebo trials in the CRF groups, while in only 70% of nocebo trials in the PRF groups. During evocation, pain stimulation was equivalent across all trials. During attenuation, pain stimulation was decreased on nocebo trials relative to control trials for the counterconditioning groups, while pain remained equivalent across all trials for the extinction groups. Results showed that both PRF and CRF significantly induced nocebo hyperalgesia, but CRF was a more potent nocebo induction method, as compared to PRF. Counterconditioning was more effective than extinction in attenuating nocebo hyperalgesia. Neither CRF nor PRF resulted in resistance to extinction. However, compared with CRF, conditioning with PRF resulted in more resistance to counterconditioning. These findings demonstrate that the more ambiguous learning method of PRF can induce nocebo hyperalgesia and may potentially explain the treatment resistance and chronification seen in clinical practice. Further research is required to establish whether attenuation with counterconditioning is generalizable to clinical settings.",2020,"During attenuation, pain stimulation was decreased on nocebo trials relative to control trials for the counterconditioning groups, while pain remained equivalent across all trials for the extinction groups.","['Healthy participants (N = 140', 'nocebo hyperalgesia']","['nocebo hyperalgesia induction groups: conditioning with continuous reinforcement (CRF), conditioning with partial reinforcement (PRF), and a sham-conditioning control group', 'PRF and CRF']","['nocebo hyperalgesia', 'pain stimulation', 'thermal pain']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C3658218', 'cui_str': 'Nocebo'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesic Sensations'}]","[{'cui': 'C3658218', 'cui_str': 'Nocebo'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesic Sensations'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0035007', 'cui_str': 'Reinforcement'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033374', 'cui_str': 'Prolactin-Releasing Peptide'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}]","[{'cui': 'C3658218', 'cui_str': 'Nocebo'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesic Sensations'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]",140.0,0.0465884,"During attenuation, pain stimulation was decreased on nocebo trials relative to control trials for the counterconditioning groups, while pain remained equivalent across all trials for the extinction groups.","[{'ForeName': 'Mia Athina', 'Initials': 'MA', 'LastName': 'Thomaidou', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'Dieuwke Swaantje', 'Initials': 'DS', 'LastName': 'Veldhuijzen', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'Kaya Joanne', 'Initials': 'KJ', 'LastName': 'Peerdeman', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'Naomi Zoë Sifra', 'Initials': 'NZS', 'LastName': 'Wiebing', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'Joseph Sullivan', 'Initials': 'JS', 'LastName': 'Blythe', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'Andrea Walbruga Maria', 'Initials': 'AWM', 'LastName': 'Evers', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Leiden University, Leiden, the Netherlands.'}]",Pain,['10.1097/j.pain.0000000000001861']
563,31408838,APOE gene-dependent BOLD responses to a breath-hold across the adult lifespan.,"Age and apolipoprotein E (APOE) e4 genotype are two of the strongest known risk factors for sporadic Alzheimer's disease (AD). Neuroimaging has shown hemodynamic response changes with age, in asymptomatic carriers of the APOE e4 allele, and in AD. In this study, we aimed to characterize and differentiate age- and APOE gene-specific hemodynamic changes to breath-hold and visual stimulation. A further aim was to study whether these responses were modulated by 3-day intake of nitrate, a nitric oxide (NO) source. The study was designed as a randomized, double-blinded, placebo-controlled crossover study, and the study cohort comprised 41 APOE e4 carriers (e3/e4 or e4/e4 genotype) and 40 non-carriers (e3/e3 genotype) aged 30-70 years at enrollment. The participants underwent two scanning sessions, each preceded by ingestion of sodium nitrate or sodium chloride (control). During functional magnetic resonance imaging (fMRI) sessions, participants performed two concurrent tasks; a breath-hold task to probe cerebrovascular reactivity and a visual stimulation task to evoke functional hyperemia, respectively. We found that the blood oxygenation level dependent (BOLD) hemodynamic response to breath-hold was altered in APOE e4 carriers relative to non-carriers. Mid-aged (50-60 years of age) e4 carriers exhibited a significantly increased peak time relative to mid-aged e3 carriers, and peak time for younger (30-40 years of age) e4 carriers was significantly shorter than that of mid-aged e4 carriers. The response width was significantly increased for e4 carriers. The response peak magnitude significantly decreased with age. For the visual stimulation task, we found age-related changes, with reduced response magnitude with age but no significant effect of APOE allele type. We found no effect of nitrate ingestion on BOLD responses evoked by the breath-hold and visual stimulation tasks. The APOE gene-dependent response to breath-hold may reflect NO-independent differences in vascular function.",2019,"For the visual stimulation task, we found age-related changes, with reduced response magnitude with age but no significant effect of APOE allele type.",['41 APOE e4 carriers (e3/e4 or e4/e4 genotype) and 40 non-carriers (e3/e3 genotype) aged 30-70\u202fyears at enrollment'],"['sodium nitrate or sodium chloride (control', 'placebo', 'functional magnetic resonance imaging (fMRI) sessions', 'nitrate ingestion']","['response peak magnitude', 'blood oxygenation level dependent (BOLD) hemodynamic response', 'peak time relative', 'response width', 'Age and apolipoprotein E (APOE']","[{'cui': 'C0003595', 'cui_str': 'Apo-E'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0560175', 'cui_str': 'Carrier State'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0074748', 'cui_str': 'sodium nitrate'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0523511', 'cui_str': 'Apolipoproteins E measurement (procedure)'}, {'cui': 'C0003595', 'cui_str': 'Apo-E'}]",,0.218788,"For the visual stimulation task, we found age-related changes, with reduced response magnitude with age but no significant effect of APOE allele type.","[{'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Rasmussen', 'Affiliation': 'Center of Functionally Integrative Neuroscience, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark. Electronic address: pmr@cfin.au.dk.'}, {'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Aamand', 'Affiliation': 'Center of Functionally Integrative Neuroscience, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Eddie', 'Initials': 'E', 'LastName': 'Weitzberg', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Christiansen', 'Affiliation': 'Department for Congenital Disorders, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Østergaard', 'Affiliation': 'Center of Functionally Integrative Neuroscience, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Torben E', 'Initials': 'TE', 'LastName': 'Lund', 'Affiliation': 'Center of Functionally Integrative Neuroscience, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.101955']
564,31368793,Facilitators and barriers to successful recruitment into a large comparative effectiveness trial: a qualitative study.,"Background:  Recruitment of participants into research studies, especially individuals from minority groups, is challenging; lack of diversity may lead to biased findings.  Aim:  To explore beliefs about research participation among individuals who were approached and eligible for the GRADE study.  Methods:  In-depth qualitative telephone interviews with randomized participants (n = 25) and eligible individuals who declined to enroll (n = 26).  Results:  Refusers and consenters differed in trust and perceptions of risk, benefits and burden of participation. Few participants understood how comparative effectiveness research differed from other types of trials; however, some features of comparative effectiveness research were perceived as lower risk.  Conclusion:  We identified facilitators and addressable barriers to participation in research studies.",2019,"Results:  Refusers and consenters differed in trust and perceptions of risk, benefits and burden of participation.","['randomized participants (n\xa0=\xa025) and eligible individuals who declined to enroll (n\xa0=\xa026', 'participants into research studies, especially individuals from minority groups', 'individuals who were approached and eligible for the GRADE study']",[],"['trust and perceptions of risk, benefits and burden of participation']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0035168'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]",[],"[{'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.150427,"Results:  Refusers and consenters differed in trust and perceptions of risk, benefits and burden of participation.","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Behringer-Massera', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Diabetes and Bone Diseases, Icahn School of Medicine, 1 Gustave L Levy Place, NY 10029, USA.'}, {'ForeName': 'Terysia', 'Initials': 'T', 'LastName': 'Browne', 'Affiliation': 'Department of Family & Social Medicine, Albert Einstein College of Medicine, 1300 Morris Park Ave, Bronx, NY 10461, USA.'}, {'ForeName': 'Geny', 'Initials': 'G', 'LastName': 'George', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Albert Einstein College of Medicine, 1300 Morris Park Ave, Bronx, NY 10461, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Duran', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Albert Einstein College of Medicine, 1300 Morris Park Ave, Bronx, NY 10461, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cherrington', 'Affiliation': 'Department of Medicine, University of Alabama, Birmingham, AL 35294, USA.'}, {'ForeName': 'M Diane', 'Initials': 'MD', 'LastName': 'McKee', 'Affiliation': 'Department of Family & Social Medicine, Albert Einstein College of Medicine, 1300 Morris Park Ave, Bronx, NY 10461, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of comparative effectiveness research,['10.2217/cer-2019-0010']
565,32248552,Effect of periodontal therapy on adipokine biomarkers in overweight.,"AIM


The aim of this study was to evaluate the effect of non-surgical periodontal therapy on circulating levels of the systemic inflammation-associated biomarkers orosomucoid (ORM), high-sensitivity C-reactive protein (hsCRP), chemerin, and retinol-binding protein 4 (RBP4) in overweight or normal-weight patients with periodontitis at 27.5 months after therapy.
MATERIALS AND METHODS


This exploratory subanalysis includes patients from the ABPARO-trial (ClinicalTrials.gov NCT00707369). The per-protocol collective provided untreated periodontitis patients with high (≥28 kg/m 2  ) or moderate (21-24 kg/m 2  ) BMI. Out of the per-protocol collective, 80 patients were randomly selected and stratified for BMI group, sex, and treatment group (antibiotics/placebo), resulting in 40 overweight and normal-weight patients. Patients received non-surgical periodontal therapy and maintenance at 3-month intervals. Plasma samples from baseline and 27.5 months following initial treatment were used to measure the concentrations of ORM, hsCRP, chemerin, and RBP4.
RESULTS


At the 27.5-month examination, ORM and hsCRP decreased noticeably in the overweight group (ORM: p = .001, hsCRP: p = .004) and normal-weight patients (ORM: p = .007, hsCRP: p < .001). Chemerin decreased in the overweight group (p = .048), and RBP4 concentrations remained stable.
CONCLUSION


Non-surgical periodontal therapy reduced systemically elevated inflammation-associated biomarkers in periodontitis patients. These improvements were more pronounced in overweight patients than in normal-weight patients.",2020,"Chemerin decreased in the overweight group (p=0.048), and RBP4 concentrations remained stable.
","['40 overweight and normal-weight patients', 'overweight', '80 patients', 'patients from the ABPARO-trial (ClinicalTrials', 'overweight or normal-weight patients with periodontitis at 27.5 months after therapy', 'untreated periodontitis patients with high (≥ 28 kg/m 2  ) or moderate (21-24 kg/m 2  ) BMI', 'periodontitis patients']","['periodontal therapy', 'non-surgical periodontal therapy', 'hsCRP', 'BMI group, sex, and treatment group (antibiotics/placebo']","['RBP4 concentrations', 'concentrations of ORM, hsCRP, chemerin, and RBP4', 'ORM and hsCRP', 'adipokine biomarkers', 'Chemerin', 'circulating levels of the systemic inflammation-associated biomarkers orosomucoid (ORM), high-sensitivity C-reactive protein (hsCRP), chemerin, and retinol-binding protein 4 (RBP4']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C4517674', 'cui_str': '27.5'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1438309', 'cui_str': 'RBP4 protein, human'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0574158', 'cui_str': 'Oromo language'}, {'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0029297', 'cui_str': 'Alpha-1- acid glycoprotein'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",80.0,0.0345811,"Chemerin decreased in the overweight group (p=0.048), and RBP4 concentrations remained stable.
","[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Matern', 'Affiliation': 'Department of Periodontology and Operative Dentistry, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Koch', 'Affiliation': 'Institute of Biostatistics and Clinical Research, University of Münster, Münster, Germany.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Petersmann', 'Affiliation': 'Institute of Clinical Chemistry and Laboratory Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kocher', 'Affiliation': 'Unit of Periodontology, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Eickholz', 'Affiliation': 'Department of Periodontology, Johann Wolfgang Goethe-University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Lorenz', 'Affiliation': 'Department of Periodontology, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Ti-Sun', 'Initials': 'TS', 'LastName': 'Kim', 'Affiliation': 'Section of Periodontology, Department of Conservative Dentistry, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Meyle', 'Affiliation': 'Department of Periodontology, University of Giessen, Giessen, Germany.'}, {'ForeName': 'Doğan', 'Initials': 'D', 'LastName': 'Kaner', 'Affiliation': 'Departments of Periodontology and Synoptic Dentistry, Charite-Universitatsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Schlagenhauf', 'Affiliation': 'Department of Periodontology, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Gravemeier', 'Affiliation': 'Department of Periodontology and Operative Dentistry, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Harks', 'Affiliation': 'Department of Periodontology and Operative Dentistry, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Ehmke', 'Affiliation': 'Department of Periodontology and Operative Dentistry, University Hospital Münster, Münster, Germany.'}]",Journal of clinical periodontology,['10.1111/jcpe.13288']
566,32248591,"In infants with sufficient vitamin D status at birth, vitamin D supplementation does not impact immune development.","BACKGROUND


Low vitamin D levels have been associated with allergic diseases. Vitamin D has potent immunomodulatory properties, but the mechanisms remain unclear. We have investigated the effect of oral vitamin D supplementation on circulating immune cell phenotypes in infants.
METHOD


A double-blinded randomised controlled trial was conducted to investigate the effect of oral vitamin D supplementation (400 IU/d) on eczema and immune development. A subset of 78 infants was included in this analysis. Phenotypic analysis of immune cell subsets was performed using flow cytometry.
RESULTS


Vitamin D supplementation resulted in median 25(OH)D levels of 80.5 vs 59.5 nmol/L in the placebo group at 3 months of age (P = .002) and 87.5 vs 77 nmol/L at 6 months of age (P = .08). We observed significant changes in immune cell composition from birth (cord blood) to 6 months of age. Vitamin D supplementation did not impact these changes, nor did immune cell composition correlate with plasma 25(OH)D levels. Through exploratory analysis, we identified possible associations with eczema development and increased abundance of naïve CD4 -  T cells at birth, as well as associations with basophils, iNKT and central memory CD4 +  T cells, and altered expression patterns of IgE receptor (FcεR1) on monocytes and dendritic cells with eczema at 6 months.
CONCLUSIONS


Vitamin D supplementation in infants who were vitamin D sufficient at birth did not affect developmental changes in immune cells during the first 6 months of life. However, immune cell profiles at birth and at 6 months of age were associated with early life eczema.",2020,"Vitamin D supplementation did not impact these changes, nor did immune cell composition correlate with plasma 25(OH)D levels.",['78 infants'],"['vitamin D supplementation', 'placebo', 'Vitamin D', 'Vitamin D supplementation', 'oral vitamin D supplementation']","['immune cell composition from birth (cord blood', 'abundance of naïve CD4 -  T cells at birth, as well as associations with basophils, iNKT and central memory CD4 +  T cells and altered expression patterns of IgE receptor (FcεR1) on monocytes and dendritic cells with eczema', 'eczema and immune development', 'median 25(OH)D levels']","[{'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0004827', 'cui_str': 'Basophils'}, {'cui': 'C2350467', 'cui_str': 'iNKT Cells'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0003315', 'cui_str': 'Immunologic Accessory Cells'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.446861,"Vitamin D supplementation did not impact these changes, nor did immune cell composition correlate with plasma 25(OH)D levels.","[{'ForeName': 'Jonatan', 'Initials': 'J', 'LastName': 'Leffler', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Nedlands, WA, Australia.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Gamez', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Nedlands, WA, Australia.'}, {'ForeName': 'Anderson P', 'Initials': 'AP', 'LastName': 'Jones', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Nedlands, WA, Australia.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Rueter', 'Affiliation': 'School of Medicine, The University of Western Australia, Crawley, WA, Australia.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Read', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Nedlands, WA, Australia.'}, {'ForeName': 'Aris', 'Initials': 'A', 'LastName': 'Siafarikas', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Nedlands, WA, Australia.'}, {'ForeName': 'Ee-Mun', 'Initials': 'EM', 'LastName': 'Lim', 'Affiliation': 'Department of Endocrinology and Diabetes, Sir Charles Gairdner Hospital, Nedlands, WA, Australia.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Noakes', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Nedlands, WA, Australia.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Prescott', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Nedlands, WA, Australia.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Stumbles', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Nedlands, WA, Australia.'}, {'ForeName': 'Debra J', 'Initials': 'DJ', 'LastName': 'Palmer', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Nedlands, WA, Australia.'}, {'ForeName': 'Deborah H', 'Initials': 'DH', 'LastName': 'Strickland', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Nedlands, WA, Australia.'}]",Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology,['10.1111/pai.13250']
567,31764105,Association between HIV antiretroviral therapy and preterm birth based on antenatal ultrasound gestational age determination: a comparative analysis.,"OBJECTIVE


To evaluate the association between HIV antiretroviral therapy (ART) and preterm birth (PTB), when defined by gold standard antenatal ultrasound versus newborn exam.
DESIGN


A secondary analysis of the PROMISE 1077BF/1077FF randomized controlled trial, which compared antiretroviral strategies to reduce perinatal HIV transmission and improve maternal health. The trial used newborn exam (i.e. New Ballard Score, NBS) to assess gestational age. This analysis included liveborn singleton pregnancies with both newborn exam and ultrasound data. The primary exposure was the trial's antiretroviral strategies: zidovudine with intrapartum nevirapine ('ZDV alone'); zidovudine/lamivudine/lopinavir-ritonavir ('ZDV-based ART'); or tenofovir/emtricitabine/lopinavir-ritonavir ('TDF-based ART'). The primary outcome was PTB less than 37 and less than 34 weeks based on the gold standard of ultrasound dating. We evaluated the association between antiretroviral strategy and PTB. We fit multivariable logistic regression models, adjusting for maternal characteristics, obstetric history, and HIV disease severity.
RESULTS


Among 720 assessed pregnant women, PTB less than 37 weeks was 15.4% by NBS and 18.3% by ultrasound. The NBS was specific but not sensitive for PTB less than 37 weeks (92.0% and 48.5%). Women receiving ZDV-based and TDF-based ART had significantly higher odds of PTB less than 37 by ultrasound compared with ZDV alone (adjusted odds ratios: 1.68; 95% confidence interval 1.10-2.57, and 2.71; 95% confidence interval 1.39-5.29), as well as for PTB less than 34 weeks. These results held for ultrasounds performed less than 24 weeks, and were generally consistent with prior analyses from the PROMISE trial using the NBS.
CONCLUSION


Women starting HIV ART in pregnancy remained at higher risk of PTB when determined by ultrasound, consistent with prior data using newborn exam. However, newborn exam misclassified cases of PTB compared with gold standard ultrasound.",2019,"Women receiving ZDV-based and TDF-based ART had significantly higher odds of PTB less than 37 by ultrasound compared with ZDV alone (adjusted odds ratios: 1.68; 95% confidence interval 1.10-2.57, and 2.71; 95% confidence interval 1.39-5.29), as well as for PTB less than 34 weeks.",['liveborn singleton pregnancies with both newborn exam and ultrasound data'],"['HIV antiretroviral therapy (ART) and preterm birth (PTB', 'ZDV', ""zidovudine with intrapartum nevirapine ('ZDV alone'); zidovudine/lamivudine/lopinavir-ritonavir ('ZDV-based ART'); or tenofovir/emtricitabine/lopinavir-ritonavir ('TDF-based ART""]",['perinatal HIV transmission and improve maternal health'],"[{'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0043474', 'cui_str': 'Zidovudine'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum (qualifier value)'}, {'cui': 'C0132326', 'cui_str': 'Nevirapine'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0024921', 'cui_str': 'Maternal Health'}]",720.0,0.198607,"Women receiving ZDV-based and TDF-based ART had significantly higher odds of PTB less than 37 by ultrasound compared with ZDV alone (adjusted odds ratios: 1.68; 95% confidence interval 1.10-2.57, and 2.71; 95% confidence interval 1.39-5.29), as well as for PTB less than 34 weeks.","[{'ForeName': 'Kartik Kailas', 'Initials': 'KK', 'LastName': 'Venkatesh', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Farhad', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Center for Biostatistics in AIDS Research, Boston, Massachusetts, USA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Fenton', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Center for Biostatistics in AIDS Research, Boston, Massachusetts, USA.'}, {'ForeName': 'Dhayendre', 'Initials': 'D', 'LastName': 'Moodley', 'Affiliation': 'Centre for AIDS Research in South Africa and Department of Obstetrics and Gynecology, School of Clinical Medicine, University of KwaZulu Natal, Durban, South Africa.'}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Naik', 'Affiliation': 'Byramiee Jeejeebhoy Government Medical College, Pune, India.'}, {'ForeName': 'Clemensia', 'Initials': 'C', 'LastName': 'Nakabiito', 'Affiliation': 'Makerere University, Kampala, Uganda.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Fairlie', 'Affiliation': 'Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Mary Glenn', 'Initials': 'MG', 'LastName': 'Fowler', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Jeffrey S A', 'Initials': 'JSA', 'LastName': 'Stringer', 'Affiliation': ""Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.""}, {'ForeName': 'Benjamin H', 'Initials': 'BH', 'LastName': 'Chi', 'Affiliation': ""Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.""}]","AIDS (London, England)",['10.1097/QAD.0000000000002367']
568,31795035,Stability of frontal alpha asymmetry in depressed patients during antidepressant treatment.,"INTRODUCTION


Frontal alpha asymmetry (FAA) is a proposed prognostic biomarker in major depressive disorder (MDD), conventionally acquired with electroencephalography (EEG). Although small studies attributed trait-like properties to FAA, a larger sample is needed to reliably asses this characteristic. Furthermore, to use FAA to predict treatment response, determining its stability, including the potential dependency on depressive state or medication, is essential.
METHODS


In the international Study to Predict Optimized Treatment in Depression (iSPOT-D), a multi-center, randomized, prospective open-label trial, 1008 MDD participants were randomized to treatment with escitalopram, sertraline or venlafaxine-extended release. Treatment response was established eight weeks after treatment initiation and resting state EEG was measured both at baseline and after eight weeks (n = 453).
RESULTS


FAA did not change significantly after eight weeks of treatment (n = 453, p = .234), nor did we find associations with age, sex, depression severity, or change in depression severity. After randomizing females to escitalopram or sertraline, for whom treatment response could be predicted in an earlier study, FAA after eight weeks resulted in equivalent response prediction as baseline FAA (one tailed p = .028).
CONCLUSION


We demonstrate that FAA is a stable trait, robust to time, state and pharmacological status. This confirms FAA stability. Furthermore, as prediction of treatment response is irrespective of moment of measurement and use of medication, FAA can be used as a state-invariant prognostic biomarker with promise to optimize MDD treatments.",2019,"RESULTS


FAA did not change significantly after eight weeks of treatment (n = 453, p = .234), nor did we find associations with age, sex, depression severity, or change in depression severity.","['1008 MDD participants', 'depressed patients during antidepressant treatment']","['escitalopram, sertraline or venlafaxine-extended release', 'FAA', 'Frontal alpha asymmetry (FAA', 'sertraline']","['resting state EEG', 'Stability of frontal alpha asymmetry']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry (qualifier value)'}]","[{'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry (qualifier value)'}]",1008.0,0.02721,"RESULTS


FAA did not change significantly after eight weeks of treatment (n = 453, p = .234), nor did we find associations with age, sex, depression severity, or change in depression severity.","[{'ForeName': 'Nikita', 'Initials': 'N', 'LastName': 'van der Vinne', 'Affiliation': 'Research Institute Brainclinics, Nijmegen, The Netherlands; Synaeda Psycho Medisch Centrum, Leeuwarden, The Netherlands; Department of Clinical Neurophysiology, Technical Medical Centre, University of Twente, Enschede, The Netherlands. Electronic address: n.van.der.vinne@synaeda.nl.'}, {'ForeName': 'Madelon A', 'Initials': 'MA', 'LastName': 'Vollebregt', 'Affiliation': 'Research Institute Brainclinics, Nijmegen, The Netherlands; Department of Cognitive Neuroscience, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Michel J A M', 'Initials': 'MJAM', 'LastName': 'van Putten', 'Affiliation': 'Department of Clinical Neurophysiology, Technical Medical Centre, University of Twente, Enschede, The Netherlands; Department of Clinical Neurophysiology and Neurology, Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Arns', 'Affiliation': 'Research Institute Brainclinics, Nijmegen, The Netherlands; Department of Experimental Psychology, Utrecht University, Utrecht, The Netherlands.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.102056']
569,32244424,Effects of Double-Taped Kinesio Taping on Pain and Functional Performance due to Muscle Fatigue in Young Males: A Randomized Controlled Trial.,"Kinesio taping (KT) is widely applied for pain control and rehabilitation in clinical settings. Tape tension is a key factor in the taping method. However, limited evidence exists regarding the reinforced tension effects of KT on functional performance and pain in healthy individuals. This study aimed to investigate the immediate effects of double-taped Kinesio taping (DTKT) on functional performance and pain caused by muscle fatigue after exercise. A total of 44 healthy male students (mean age, 23.3 ± 2.2 years) were randomly assigned to the following three groups: DTKT, normal-tape Kinesio taping (NTKT), and placebo. The single-hopping (SH) distance, vertical jump height (VJH), and power (VJP) were assessed at baseline. The muscle fatigue protocol was then applied to induce muscle soreness. Outcome measures including subjective pain, SH distance, VJH and VJP were evaluated immediately after the muscle fatigue protocol, and KT was then applied; the measures were then again evaluated immediately and 24 h after KT application. No significant interactions between pain and functional performance were observed ( p  > 0.05), and there were no significant differences in SH, VJH, and VJP among the groups ( p  > 0.05). Notably, the DTKT had an immediate effect on the alleviation of pain caused by muscle fatigue. The present findings indicate that DTKT is not superior to NTKT or placebo in terms of pain relief and enhancing functional performance after tape application in healthy male students.",2020,"Outcome measures including subjective pain, SH distance, VJH and VJP were evaluated immediately after the muscle fatigue protocol, and KT was then applied; the measures were then again evaluated immediately and 24 h after KT application.","['44 healthy male students (mean age, 23.3 ± 2.2 years', 'healthy individuals', 'Young Males', 'healthy male students']","['placebo', 'Double-Taped Kinesio Taping', 'Kinesio taping (KT', 'normal-tape Kinesio taping (NTKT), and placebo', 'KT', 'double-taped Kinesio taping (DTKT']","['SH, VJH, and VJP', 'single-hopping (SH) distance, vertical jump height (VJH), and power (VJP', 'Pain and Functional Performance', 'alleviation of pain', 'pain and functional performance', 'functional performance and pain', 'pain relief and enhancing functional performance', 'subjective pain, SH distance, VJH and VJP']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",44.0,0.0629081,"Outcome measures including subjective pain, SH distance, VJH and VJP were evaluated immediately after the muscle fatigue protocol, and KT was then applied; the measures were then again evaluated immediately and 24 h after KT application.","[{'ForeName': 'Haneul', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, Gachon University, Inchon 21936, Korea.'}, {'ForeName': 'Hyoungwon', 'Initials': 'H', 'LastName': 'Lim', 'Affiliation': 'Department of Physical Therapy, Dankook University, Cheonan 31116, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17072364']
570,32244495,"Entrepreneurial, Economic, and Social Well-Being Outcomes from an RCT of a Youth Entrepreneurship Education Intervention among Native American Adolescents.","Background:  Entrepreneurship education has demonstrated positive impacts in low-resource contexts. However, there is limited evidence of such programs evaluated among Native American (NA) youth in a rural reservation.  Methods:  A 2:1 randomized controlled trial evaluated the impact of the Arrowhead Business Group (ABG) entrepreneurship education program on entrepreneurship knowledge, economic empowerment, and social well-being among 394 NA youth. An intent to treat analysis using mixed effects regression models examined within and between study group differences from baseline to 24 months. An interaction term measured change in the intervention relative to change in the control. ABG participants were purposively sampled to conduct focus groups and in-depth interviews.  Results:  Significant intervention vs. control group improvements were sustained at 12 months for entrepreneurship knowledge and economic confidence/security. Significant within-group improvements were sustained for ABG participants at 24 months for connectedness to parents, school, and awareness of connectedness. Qualitative data endorses positive impacts on social well-being among ABG participants.  Conclusion:  Observed effects on entrepreneurship knowledge, economic empowerment, and connectedness, supplemented by the experiences and changes as described by the youth themselves, demonstrates how a strength-based youth entrepreneurship intervention focused on developing assets and resources may be an innovative approach to dually address health and economic disparities endured in Native American communities.",2020,Results:  Significant intervention vs. control group improvements were sustained at 12 months for entrepreneurship knowledge and economic confidence/security.,"['Native American Adolescents', '394 NA youth', 'ABG participants', 'Native American (NA) youth in a rural reservation']",['Arrowhead Business Group (ABG) entrepreneurship education program'],['entrepreneurship knowledge and economic confidence/security'],"[{'cui': 'C0282204', 'cui_str': 'Native Americans'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}]","[{'cui': 'C0453107', 'cui_str': 'Arrowhead'}, {'cui': 'C0085936', 'cui_str': 'Business'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0085116', 'cui_str': 'Entrepreneurship'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0085116', 'cui_str': 'Entrepreneurship'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",,0.034813,Results:  Significant intervention vs. control group improvements were sustained at 12 months for entrepreneurship knowledge and economic confidence/security.,"[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Tingey', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, 415 N. Washington St., Baltimore, MD 21231, USA.'}, {'ForeName': 'Francene', 'Initials': 'F', 'LastName': 'Larzelere', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, 308 Kuper St., Whiteriver, AZ 85941, USA.'}, {'ForeName': 'Novalene', 'Initials': 'N', 'LastName': 'Goklish', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, 308 Kuper St., Whiteriver, AZ 85941, USA.'}, {'ForeName': 'Summer', 'Initials': 'S', 'LastName': 'Rosenstock', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, 415 N. Washington St., Baltimore, MD 21231, USA.'}, {'ForeName': 'Larissa Jennings', 'Initials': 'LJ', 'LastName': 'Mayo-Wilson', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, 415 N. Washington St., Baltimore, MD 21231, USA.'}, {'ForeName': 'Elliott', 'Initials': 'E', 'LastName': 'Pablo', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, 308 Kuper St., Whiteriver, AZ 85941, USA.'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Goklish', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, 308 Kuper St., Whiteriver, AZ 85941, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Grass', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, 308 Kuper St., Whiteriver, AZ 85941, USA.'}, {'ForeName': 'Feather', 'Initials': 'F', 'LastName': 'Sprengeler', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, 308 Kuper St., Whiteriver, AZ 85941, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Parker', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, 308 Kuper St., Whiteriver, AZ 85941, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Ingalls', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, 415 N. Washington St., Baltimore, MD 21231, USA.'}, {'ForeName': 'Mariddie', 'Initials': 'M', 'LastName': 'Craig', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, 308 Kuper St., Whiteriver, AZ 85941, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Barlow', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, 415 N. Washington St., Baltimore, MD 21231, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17072383']
571,31505367,Blame-rebalance fMRI neurofeedback in major depressive disorder: A randomised proof-of-concept trial.,"Previously, using fMRI, we demonstrated lower connectivity between right anterior superior temporal (ATL) and anterior subgenual cingulate (SCC) regions while patients with major depressive disorder (MDD) experience guilt. This neural signature was detected despite symptomatic remission which suggested a putative role in vulnerability. This randomised controlled double-blind parallel group clinical trial investigated whether patients with MDD are able to voluntarily modulate this neural signature. To this end, we developed a fMRI neurofeedback software (FRIEND), which measures ATL-SCC coupling and displays its levels in real time. Twenty-eight patients with remitted MDD were randomised to two groups, each receiving one session of fMRI neurofeedback whilst retrieving guilt and indignation/anger-related autobiographical memories. They were instructed to feel the emotion whilst trying to increase the level of a thermometer-like display on a screen. Active intervention group: The thermometer levels increased with increasing levels of ATL-SCC correlations in the guilt condition. Control intervention group: The thermometer levels decreased when correlation levels deviated from the previous baseline level in the guilt condition, thus reinforcing stable correlations. Both groups also received feedback during the indignation condition reinforcing stable correlations. We confirmed our predictions that patients in the active intervention group were indeed able to increase levels of ATL-SCC correlations for guilt vs. indignation and their self-esteem after training compared to before training and that this differed significantly from the control intervention group. These data provide proof-of-concept for a novel treatment target for MDD patients and are in keeping with the hypothesis that ATL-SCC connectivity plays a key role in self-worth. https://clinicaltrials.gov/ct2/show/results/NCT01920490.",2019,This randomised controlled double-blind parallel group clinical trial investigated whether patients with MDD are able to voluntarily modulate this neural signature.,"['patients with major depressive disorder (MDD) experience guilt', 'major depressive disorder', 'patients with MDD', 'Twenty-eight patients with remitted MDD']","['fMRI neurofeedback whilst retrieving guilt and indignation/anger-related autobiographical memories', 'Control intervention']","['levels of ATL-SCC correlations', 'lower connectivity between right anterior superior temporal (ATL) and anterior subgenual cingulate (SCC) regions', 'levels of ATL-SCC correlations for guilt vs. indignation and their self-esteem']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0018379', 'cui_str': 'Guilt'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0439600', 'cui_str': 'Remitting (qualifier value)'}]","[{'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0018379', 'cui_str': 'Guilt'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0441997', 'cui_str': 'Right anterior (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0018427', 'cui_str': 'Cingulate Body'}, {'cui': 'C0018379', 'cui_str': 'Guilt'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}]",28.0,0.0826356,This randomised controlled double-blind parallel group clinical trial investigated whether patients with MDD are able to voluntarily modulate this neural signature.,"[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Zahn', 'Affiliation': ""Centre for Affective Disorders, Institute of Psychiatry, Psychology & Neuroscience, King's College London, United Kingdom.""}, {'ForeName': 'Julie H', 'Initials': 'JH', 'LastName': 'Weingartner', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Basilio', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Bado', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Instituto de Ciências Biomédicas (ICB), Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil.""}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Mattos', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'João R', 'Initials': 'JR', 'LastName': 'Sato', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Center for Mathematics, Computation, and Cognition, Universidade Federal do ABC, Santo André, Brazil.""}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'de Oliveira-Souza', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Gaffrée e Guinle University Hospital, Federal University of the State of Rio de Janeiro, Rio de Janeiro, Brazil.""}, {'ForeName': 'Leo F', 'Initials': 'LF', 'LastName': 'Fontenelle', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Allan H', 'Initials': 'AH', 'LastName': 'Young', 'Affiliation': ""Centre for Affective Disorders, Institute of Psychiatry, Psychology & Neuroscience, King's College London, United Kingdom.""}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Moll', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Scients Institute, Palo Alto, USA. Electronic address: jorge.moll@idor.org.""}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.101992']
572,31298289,"Perineural Platelet-Rich Plasma for Diabetic Neuropathic Pain, Could It Make a Difference?","OBJECTIVE


To evaluate the clinical effect of perineural platelet-rich plasma (PRP) injection for pain and numbness alleviation in diabetic peripheral neuropathy (DPN).
STUDY DESIGN


A randomized prospective clinical trial.
SETTING


Pain clinic and Rheumatology and Rehabilitation Departments, Assiut University Hospital.
METHODS


Sixty adult patients with type II DM accompanied by DPN of at least six months' duration were assessed by modified Toronto Clinical Neuropathy Score (mTCNS) and randomly allocated into two groups. Group I underwent ultrasound-guided perineural PRP injection and medical treatment, and Group II received medical treatment only. Patients were followed up at months 1, 3, and 6 with regard to pain and numbness visual analog scale (VAS) and mTCNS scores.
RESULTS


Significant improvement was recorded in pain and numbness VAS scale scores in group I vs group II (P ≤ 0.001 during the whole study period for both parameters); at the same time, mTCNS improved in group I in comparison with group II with P = 0.01, 0.001, and <0.001 at months 1, 3, and 6, respectively.
CONCLUSIONS


Perineural PRP injection is an effective therapy for alleviation of diabetic neuropathy pain and numbness and enhancement of peripheral nerve function.",2020,"RESULTS


Significant improvement was recorded in pain and numbness VAS scale scores in group I vs group II (P ≤ 0.001 during the whole study period for both parameters); at the same time, mTCNS improved in group I in comparison with group II with P = 0.01, 0.001, and <0.001 at months 1, 3, and 6, respectively.
","[""Sixty adult patients with type II DM accompanied by DPN of at least six months' duration were assessed by modified Toronto Clinical Neuropathy Score (mTCNS"", 'Pain clinic and Rheumatology and Rehabilitation Departments, Assiut University Hospital', 'diabetic peripheral neuropathy (DPN']","['ultrasound-guided perineural PRP injection and medical treatment, and Group II received medical treatment only', 'Perineural PRP injection', 'perineural platelet-rich plasma (PRP) injection']","['pain and numbness VAS scale scores', 'pain and numbness visual analog scale (VAS) and mTCNS scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242936', 'cui_str': 'Pain Centers'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0587478', 'cui_str': 'Rehabilitation department (environment)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0740447', 'cui_str': 'Peripheral neuropathy co-occurrent and due to diabetes mellitus'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0020580', 'cui_str': 'Reduced Sensation'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",60.0,0.04181,"RESULTS


Significant improvement was recorded in pain and numbness VAS scale scores in group I vs group II (P ≤ 0.001 during the whole study period for both parameters); at the same time, mTCNS improved in group I in comparison with group II with P = 0.01, 0.001, and <0.001 at months 1, 3, and 6, respectively.
","[{'ForeName': 'Manal', 'Initials': 'M', 'LastName': 'Hassanien', 'Affiliation': 'Rheumatology and Rehabilitation Department, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Abdelraheem', 'Initials': 'A', 'LastName': 'Elawamy', 'Affiliation': 'Anesthesia, Intensive Care and Pain Department Department, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Emad Zarief', 'Initials': 'EZ', 'LastName': 'Kamel', 'Affiliation': 'Anesthesia, Intensive Care and Pain Department Department, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Walaa A', 'Initials': 'WA', 'LastName': 'Khalifa', 'Affiliation': 'Internal Medicine Department, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Ghada Mohamed', 'Initials': 'GM', 'LastName': 'Abolfadl', 'Affiliation': 'Anesthesia, Intensive Care and Pain Department Department, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Al Shimaa Ismael', 'Initials': 'ASI', 'LastName': 'Roushdy', 'Affiliation': 'Anesthesia, Intensive Care and Pain Department, Faculty of Medicine, Minia University, Minia, Egypt.'}, {'ForeName': 'Randa A', 'Initials': 'RA', 'LastName': 'El Zohne', 'Affiliation': 'Clinical Pathology Department, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Yasmine S', 'Initials': 'YS', 'LastName': 'Makarem', 'Affiliation': 'Rheumatology and Rehabilitation Department, Faculty of Medicine, Assiut University, Assiut, Egypt.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz140']
573,31396834,Safety of adalimumab biosimilar MSB11022 (acetate-buffered formulation) in patients with moderately-to-severely active rheumatoid arthritis.,"OBJECTIVES


To compare the safety, efficacy, and immunogenicity of MSB11022 (acetate-buffered formulation), an adalimumab biosimilar, with the reference product.
METHOD


AURIEL-RA study was a phase 3, multicenter, randomized, double-blind, parallel group trial (NCT03052322). Patients with moderately-to-severely active rheumatoid arthritis (RA) with an inadequate response to methotrexate were randomized 1:1 to MSB11022 or reference adalimumab. The primary endpoint was the incidence of treatment-emergent adverse events of special interest (AESIs) (predefined as hypersensitivity) up to week 52. The key secondary endpoint was ACR20 (≥ 20% improvement in American College of Rheumatology core set measurements from baseline) at week 12. Other efficacy endpoints, quality of life, immunogenicity, and pharmacokinetic parameters were evaluated up to week 52. Secondary safety endpoints were evaluated up to week 52 and at a 4-month safety follow-up.
RESULTS


In total, 288 patients were randomized. The proportion of patients experiencing ≥ 1 treatment-emergent AESI up to week 52 was similar between trial arms: 6 patients (4.2%; 95% CI 1.56, 8.91) receiving MSB11022, and 8 patients (5.5%; 95% CI 2.41, 10.58) receiving reference adalimumab. No clinically meaningful differences in efficacy, quality of life, or immunogenicity were seen between treatment arms up to week 52. No notable difference in the incidence of treatment-emergent adverse events was observed between treatment arms up to the end of the follow-up period.
CONCLUSIONS


These results suggest MSB11022 and reference adalimumab are similar in patients with moderately-to-severely active rheumatoid arthritis in terms of safety, immunogenicity, and efficacy. AURIEL-RA provides evidence to support the similarity of MSB11022 and adalimumab.Key Points• Incidences of hypersensitivity events were similar for MSB11022 (modified buffer) and reference adalimumab.• There was no difference in local reactions between MSB11022 (modified buffer) and reference adalimumab.• AURIEL-RA confirms the equivalence in efficacy and immunogenicity of MSB11022 (modified buffer) and reference adalimumab.",2019,"No notable difference in the incidence of treatment-emergent adverse events was observed between treatment arms up to the end of the follow-up period.
","['288 patients were randomized', 'Patients with moderately-to-severely active rheumatoid arthritis (RA) with an inadequate response to', 'patients with moderately-to-severely active rheumatoid arthritis']","['MSB11022 (acetate-buffered formulation', 'methotrexate', 'MSB11022 or reference adalimumab', 'adalimumab biosimilar MSB11022 (acetate-buffered formulation']","['efficacy endpoints, quality of life, immunogenicity, and pharmacokinetic parameters', 'local reactions', 'incidence of treatment-emergent adverse events of special interest (AESIs) (predefined as hypersensitivity', 'incidence of treatment-emergent adverse events', 'efficacy, quality of life, or immunogenicity', 'ACR20', 'proportion of patients experiencing ≥\u20091 treatment-emergent AESI', 'Incidences of hypersensitivity events', 'safety, efficacy, and immunogenicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}]","[{'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}]","[{'cui': 'C0034380'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0853813', 'cui_str': 'Local reaction'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205555', 'cui_str': 'Special (qualifier value)'}, {'cui': 'C3544362', 'cui_str': 'Hypersensitivity (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",288.0,0.0968536,"No notable difference in the incidence of treatment-emergent adverse events was observed between treatment arms up to the end of the follow-up period.
","[{'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Edwards', 'Affiliation': 'NIHR Clinical Research Facility, University of Southampton, Southampton, UK. cedwards@soton.ac.uk.'}, {'ForeName': 'Joëlle', 'Initials': 'J', 'LastName': 'Monnet', 'Affiliation': 'Fresenius Kabi, Eysins, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Ullmann', 'Affiliation': 'Fresenius Kabi, Eysins, Switzerland.'}, {'ForeName': 'Pantelis', 'Initials': 'P', 'LastName': 'Vlachos', 'Affiliation': 'Cytel, Geneva, Switzerland.'}, {'ForeName': 'Veranika', 'Initials': 'V', 'LastName': 'Chyrok', 'Affiliation': 'Fresenius Kabi, Eysins, Switzerland.'}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Ghori', 'Affiliation': 'Fresenius Kabi, Eysins, Switzerland.'}]",Clinical rheumatology,['10.1007/s10067-019-04679-y']
574,31401791,Exercise training attenuates insulin resistance and improves β-cell function in patients with systemic autoimmune myopathies: a pilot study.,"INTRODUCTION/OBJECTIVES


To assess the effects of exercise training on insulin resistance and β-cell function in patients with systemic autoimmune myopathies (SAMs).
METHOD


This quasi-experimental, prospective study includes 9 patients with SAMs (six with dermatomyositis, two with antisynthetase syndrome, and one with polymyositis). Patients were submitted to a 12-week, twice a week, exercise training program comprising aerobic and resistance exercises. Baseline and after the intervention, we evaluated disease status, aerobic capacity, muscle strength, body composition, insulin resistance, and β-cell function parameters.
RESULTS


The patients have a mean age of 46.7 years and stable disease. No clinical or laboratory parameter impairment was observed after the intervention. Compared with baseline, aerobic capacity, muscle strength, and function increased after 12 weeks (P < 0.05), while no changes were observed for body composition. Data from the oral glucose tolerance test showed that exercise did not change glucose area under the curve (AUC), whereas insulin and C-peptide AUC decreased significantly (P < 0.05). Furthermore, Matsuda index and HOMA2 percentage (both surrogates of insulin resistance) also improved (P < 0.05).
CONCLUSION


Exercise training improved aerobic capacity, muscle strength, and muscle function in patients with SAMs. In addition, exercise training led to an attenuation of insulin resistance and improvements in β-cell function parameters. These data indicate that exercise training can mitigate metabolic impairments, attenuating the cardiovascular risk in SAMs.Key Points• Exercise training improved aerobic capacity, muscle strength, and function without disease impairment• Exercise training was capable of improve insulin resistance and β-cell function in patients with SAM• These results suggest that exercise can mitigate metabolic impairments in patients with SAM, attenuating the cardiovascular risk.",2019,"Compared with baseline, aerobic capacity, muscle strength, and function increased after 12 weeks (P < 0.05), while no changes were observed for body composition.","['9 patients with SAMs (six with dermatomyositis, two with antisynthetase syndrome, and one with polymyositis', 'patients with systemic autoimmune myopathies (SAMs', 'patients with systemic autoimmune myopathies', 'patients have a mean age of 46.7\xa0years and stable disease', 'patients with SAM •', 'patients with SAM', 'patients with SAMs']","['exercise training', 'Exercise training', 'exercise training program comprising aerobic and resistance exercises']","['change glucose area under the curve (AUC), whereas insulin and C-peptide AUC', 'Furthermore, Matsuda index and HOMA2 percentage', 'cardiovascular risk', 'β-cell function', 'aerobic capacity, muscle strength, and function without disease impairment •', 'disease status, aerobic capacity, muscle strength, body composition, insulin resistance, and β-cell function parameters', 'insulin resistance and β-cell function', 'body composition', 'aerobic capacity, muscle strength, and function', 'β-cell function parameters', 'aerobic capacity, muscle strength, and muscle function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011633', 'cui_str': 'Dermatopolymyositis'}, {'cui': 'C2609059', 'cui_str': 'Antisynthetase syndrome'}, {'cui': 'C0085655', 'cui_str': 'Myositis, Multiple'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C4302167', 'cui_str': 'Autoimmune myopathy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1563296', 'cui_str': 'Systolic anterior movement of mitral valve'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0231484', 'cui_str': 'Muscular activity'}]",,0.0142565,"Compared with baseline, aerobic capacity, muscle strength, and function increased after 12 weeks (P < 0.05), while no changes were observed for body composition.","[{'ForeName': 'Diego Sales', 'Initials': 'DS', 'LastName': 'de Oliveira', 'Affiliation': 'Division of Rheumatology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil. diegosales@usp.br.'}, {'ForeName': 'Isabela Bruna Pires', 'Initials': 'IBP', 'LastName': 'Borges', 'Affiliation': 'Division of Rheumatology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Jean Marcos', 'Initials': 'JM', 'LastName': 'de Souza', 'Affiliation': 'Division of Rheumatology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Gualano', 'Affiliation': 'Division of Rheumatology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Rosa Maria Rodrigues', 'Initials': 'RMR', 'LastName': 'Pereira', 'Affiliation': 'Division of Rheumatology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Samuel Katsuyuki', 'Initials': 'SK', 'LastName': 'Shinjo', 'Affiliation': 'Division of Rheumatology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.'}]",Clinical rheumatology,['10.1007/s10067-019-04738-4']
575,31410659,Predictors of poor response to urate-lowering therapy in patients with gout and hyperuricemia: a post-hoc analysis of a multicenter randomized trial.,"INTRODUCTION


Clinical guidelines have recommended a target of serum uric acid (SUA) level below 6.0 mg/dL for the urate-lowering therapy (ULT) of gout patients, but there are still a high proportion of patients failing to achieve the therapeutic target above. This study aimed to identify possible predictors of poor response to ULT in gout patients.
METHODS


We performed a post-hoc analysis of a multicenter randomized double-blind trial which assessed the efficacy of febuxostat in patients with hyperuricemia (serum urate level ≥ 8.0 mg/dL) and gout. Demographic characters and baseline data including SUA levels were collected. Poor response to ULT was defined as average SUA after ULT was more than 6.0 mg/dL. Factors associated with poor response to ULT in gout patients were analyzed, and multivariate logistic regression analysis was also carried out to find out those independent predictors.
RESULTS


A total of 370 patients were enrolled in this post-hoc analysis. Compared with those with good response to ULT, patients with poor response to ULT had younger age (P < 0.001), higher proportion of obesity (P = 0.003), higher proportion of statins use (P = 0.019), higher body mass index (BMI) (P < 0.001), higher baseline SUA (P < 0.001), higher proportion of males (P = 0.001), higher alanine transaminase (P < 0.001), higher aspartate transaminase (P = 0.017), higher total cholesterol (P = 0.005), higher triglyceride (P = 0.042), and higher low density lipoprotein (P = 0.037). Multivariate logistic regression analysis showed that younger age (odds ratio (OR) = 0.965, 95% CI 0.943-0.987, P = 0.002), higher BMI (OR = 1.133, 95% CI 1.049-1.224, P = 0.001), higher baseline SUA (OR = 1.006, 95% CI 1.002-1.009, P = 0.001), and no application of febuxostat therapy (OR = 0.41, 95% CI 0.25-0.68, P < 0.001) were independent predictors of poor response to ULT in patients with gout.
CONCLUSION


In patients with gout and hyperuricemia, younger age, higher BMI, and higher baseline SUA are predictors of poor response to ULT. These findings could help physicians better identify patients who may fail in ULT and give individualized treatment precisely.
TRIAL REGISTRATION


The trial was registered at chinadrugtrials.org.cn in 2012 (CTR20130172).Key Points• A post-hoc analysis of a multicenter randomized double-blind trial which assessed the efficacy of febuxostat in patients with hyperuricemia and gout was performed.• Multivariate logistic regression analysis showed that younger age, higher BMI, and higher baseline SUA are predictors of poor response to urate-lowering therapy.",2019,"Multivariate logistic regression analysis showed that younger age (odds ratio (OR) = 0.965, 95% CI 0.943-0.987, P = 0.002), higher BMI (OR = 1.133, 95% CI 1.049-1.224, P = 0.001), higher baseline SUA (OR = 1.006, 95% CI 1.002-1.009, P = 0.001), and no application of febuxostat therapy (OR = 0.41, 95% CI 0.25-0.68, P < 0.001) were independent predictors of poor response to ULT in patients with gout.
","['patients with gout', 'patients with hyperuricemia and gout was performed', 'patients with gout and hyperuricemia', 'patients with hyperuricemia (serum urate level\u2009≥\u20098.0\xa0mg/dL) and gout', 'gout patients', '370 patients were enrolled in this post-hoc analysis']","['febuxostat', 'ULT', 'urate-lowering therapy']","['higher triglyceride', 'higher baseline SUA', 'low density lipoprotein', 'higher total cholesterol', 'higher BMI', 'higher alanine transaminase', 'higher aspartate transaminase', 'proportion of obesity', 'serum uric acid (SUA) level', 'SUA levels', 'higher body mass index (BMI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0740394', 'cui_str': 'Hyperuricemia'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0455272', 'cui_str': 'Serum uric acid measurement'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C4517743', 'cui_str': 'Three hundred and seventy'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0935936', 'cui_str': 'Urate'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0001899', 'cui_str': 'Alanine Aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0455272', 'cui_str': 'Serum uric acid measurement'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",370.0,0.473067,"Multivariate logistic regression analysis showed that younger age (odds ratio (OR) = 0.965, 95% CI 0.943-0.987, P = 0.002), higher BMI (OR = 1.133, 95% CI 1.049-1.224, P = 0.001), higher baseline SUA (OR = 1.006, 95% CI 1.002-1.009, P = 0.001), and no application of febuxostat therapy (OR = 0.41, 95% CI 0.25-0.68, P < 0.001) were independent predictors of poor response to ULT in patients with gout.
","[{'ForeName': 'Zepeng', 'Initials': 'Z', 'LastName': 'Mu', 'Affiliation': 'The Affiliated Hospital of Qingdao University, 16 Jiangsu Road, Qingdao, 266003, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'The Affiliated Hospital of Qingdao University, 16 Jiangsu Road, Qingdao, 266003, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'The Affiliated Hospital of Qingdao University, 16 Jiangsu Road, Qingdao, 266003, China.'}, {'ForeName': 'Wenshan', 'Initials': 'W', 'LastName': 'Lv', 'Affiliation': 'The Affiliated Hospital of Qingdao University, 16 Jiangsu Road, Qingdao, 266003, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'The Affiliated Hospital of Qingdao University, 16 Jiangsu Road, Qingdao, 266003, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'The Affiliated Hospital of Qingdao University, 16 Jiangsu Road, Qingdao, 266003, China.'}, {'ForeName': 'Xiaolong', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'The Affiliated Hospital of Qingdao University, 16 Jiangsu Road, Qingdao, 266003, China.'}, {'ForeName': 'Yangang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'The Affiliated Hospital of Qingdao University, 16 Jiangsu Road, Qingdao, 266003, China.'}, {'ForeName': 'Bingfei', 'Initials': 'B', 'LastName': 'Cheng', 'Affiliation': 'The Affiliated Hospital of Qingdao University, 16 Jiangsu Road, Qingdao, 266003, China.'}, {'ForeName': 'Zhongchao', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'The Affiliated Hospital of Qingdao University, 16 Jiangsu Road, Qingdao, 266003, China. qduwangzc@163.com.'}]",Clinical rheumatology,['10.1007/s10067-019-04737-5']
576,31670070,Evidence for decreased Neurologic Pain Signature activation following thoracic spinal manipulation in healthy volunteers and participants with neck pain.,"BACKGROUND CONTEXT


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


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


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


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


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


The findings provide preliminary evidence that SM may alter the processing of pain-related brain activity within specific pain-related brain regions and support the use of brain-based models as clinical biomarkers of pain.",2019,"Activation within the NPS subregions of the dorsal anterior cingulate cortex (dACC, p = 0.012) and right secondary somatosensory cortex/operculum (rS2_Op, p = 0.045) also decreased following SM, and evoked pain was correlated with dACC activity (r RM 2  = 0.477, p = 0.019).","['healthy volunteers (Study 1, n\u202f=\u202f10, 5 females, and mean age\u202f=\u202f31.2\u202f±\u202f10.0 years', 'participants with acute to subacute neck pain (Study 2, n\u202f=\u202f24, 16 females, mean age\u202f=\u202f38.0\u202f±\u202f15.1 years', 'healthy volunteers and participants with neck pain']","['SM', 'thoracic SM', 'thoracic spinal manipulation']","['dACC activity', 'evoked mechanical pain', 'NPS activation', 'pain-related activity', 'Neurologic Pain Signature activation', 'evoked pain and NPS activation', 'NPS', 'SM, and evoked pain', 'neck pain', 'evoked pain, neck pain, and NPS activation', 'pain-related brain activity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}]","[{'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0086586', 'cui_str': 'Manipulation, Spinal'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0234252', 'cui_str': 'Mechanical pain (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}]",,0.0871702,"Activation within the NPS subregions of the dorsal anterior cingulate cortex (dACC, p = 0.012) and right secondary somatosensory cortex/operculum (rS2_Op, p = 0.045) also decreased following SM, and evoked pain was correlated with dACC activity (r RM 2  = 0.477, p = 0.019).","[{'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Weber Ii', 'Affiliation': 'Systems Neuroscience and Pain Lab, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University, Palo Alto, CA, United States. Electronic address: kenweber@stanford.edu.'}, {'ForeName': 'Tor D', 'Initials': 'TD', 'LastName': 'Wager', 'Affiliation': 'Psychology and Neuroscience, Center for Neuroscience, Institute of Cognitive Science, University of Colorado Boulder, Boulder, CO, United States.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Mackey', 'Affiliation': 'Systems Neuroscience and Pain Lab, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University, Palo Alto, CA, United States.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Elliott', 'Affiliation': 'Northern Sydney Local Health District, The Kolling Research Institute and The Faculty of Health Sciences, The University of Sydney, St. Leonards, NSW, Australia.'}, {'ForeName': 'Wen-Ching', 'Initials': 'WC', 'LastName': 'Liu', 'Affiliation': 'Center for Collaborative Brain Research, Department of Radiology, OSF HealthCare Saint Francis Medical Center, Peoria, IL, United States.'}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Sparks', 'Affiliation': 'Center of Expertise, Rehabilitation and Occupational Health, OSF HealthCare, Peoria, IL, United States; School of Physical Therapy, South College, Knoxville, TN, United States.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.102042']
577,32247660,Comparison of Oral Ibuprofen and Acetaminophen with Either Analgesic Alone for Pediatric Emergency Department Patients with Acute Pain.,"BACKGROUND


Ibuprofen (Motrin; Johnson & Johnson) and acetaminophen (APAP, paracetamol) are the most commonly used analgesics in the pediatric emergency department (ED) for managing a variety of acute traumatic and nontraumatic painful conditions. The multimodal pain management of using a combination of ibuprofen plus acetaminophen has the potential to result in greater analgesia.
OBJECTIVE


We compared the analgesic efficacy of a combination of oral ibuprofen plus acetaminophen with either analgesic alone for pediatric ED patients with acute pain.
METHODS


We performed a randomized, double-blind superiority trial assessing and comparing the analgesic efficacy of a combination of oral ibuprofen (10 mg/kg dose) plus acetaminophen (15 mg/kg per dose) to either analgesic alone for the treatment of acute traumatic and nontraumatic pain in the pediatric ED. Primary outcomes included a difference in pain scores among the three groups at 60 min.
RESULTS


We enrolled 90 patients (30 per group). The difference in mean pain scores at 60 min between acetaminophen and combination groups was 0.30 (95% confidence interval [CI] -0.84 to 1.83); between ibuprofen and combination groups was -0.33 (95% CI -1.47 to 0.80); and between acetaminophen and ibuprofen groups was 0.63 (95% CI -0.54 to 1.81). Reductions in pain scores from baseline to 60 min were similar for all patients in each of the three groups. No adverse events occurred in any group.
CONCLUSIONS


We found similar analgesic efficacy of oral ibuprofen and acetaminophen in comparison with each analgesic alone for short-term treatment of acute pain in the pediatric ED, but the trial was underpowered to demonstrate the analgesic superiority of the combination of oral ibuprofen plus acetaminophen in comparison with each analgesic alone.",2020,"We found similar analgesic efficacy of oral ibuprofen and acetaminophen in comparison with each analgesic alone for short-term treatment of acute pain in the pediatric ED, but the trial was underpowered to demonstrate the analgesic superiority of the combination of oral ibuprofen plus acetaminophen in comparison with each analgesic alone.","['pediatric ED patients with acute pain', 'acute traumatic and nontraumatic pain in the pediatric ED', 'Pediatric Emergency Department Patients with Acute Pain', 'acute pain in the pediatric ED']","['Analgesic Alone', 'analgesic alone', 'oral ibuprofen plus acetaminophen', 'ibuprofen', 'acetaminophen', 'Oral Ibuprofen and Acetaminophen', 'Ibuprofen (Motrin; Johnson & Johnson) and acetaminophen (APAP, paracetamol', 'oral ibuprofen and acetaminophen', 'ibuprofen plus acetaminophen', 'oral ibuprofen']","['adverse events', 'mean pain scores', 'analgesic efficacy', 'pain scores']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0699203', 'cui_str': 'Motrin'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",90.0,0.164881,"We found similar analgesic efficacy of oral ibuprofen and acetaminophen in comparison with each analgesic alone for short-term treatment of acute pain in the pediatric ED, but the trial was underpowered to demonstrate the analgesic superiority of the combination of oral ibuprofen plus acetaminophen in comparison with each analgesic alone.","[{'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Motov', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, New York.'}, {'ForeName': 'Mahlaqa', 'Initials': 'M', 'LastName': 'Butt', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, New York.'}, {'ForeName': 'Aidin', 'Initials': 'A', 'LastName': 'Masoudi', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, New York.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Palacios', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, New York.'}, {'ForeName': 'Catsim', 'Initials': 'C', 'LastName': 'Fassassi', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, New York.'}, {'ForeName': 'Jefferson', 'Initials': 'J', 'LastName': 'Drapkin', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, New York.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Likourezos', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, New York.'}, {'ForeName': 'Rukhsana', 'Initials': 'R', 'LastName': 'Hossain', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, New York.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Brady', 'Affiliation': 'Department of Pharmacy, Maimonides Medical Center, Brooklyn, New York.'}, {'ForeName': 'Nechama', 'Initials': 'N', 'LastName': 'Rothberger', 'Affiliation': 'Department of Pharmacy, Maimonides Medical Center, Brooklyn, New York.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Flom', 'Affiliation': 'Peter Flom Consulting, New York, New York.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Zerzan', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, New York.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, New York.'}]",The Journal of emergency medicine,['10.1016/j.jemermed.2020.02.010']
578,32249609,High cardiovascular reactivity and muscle strength attenuate hypotensive effects of isometric handgrip training in young women: A randomized controlled trial.,"OBJECTIVE


Isometric resistance training may reduce resting blood pressure (BP); however, the magnitude of this effect varies among individual subjects and few studies attempted to predict it. This study aimed to investigate the potential hypotensive effects of isometric training and their association with cardiovascular reactivity to acute isometric exercise and muscle strength in young women.
METHODS


In this randomized trial, twenty young women were randomly assigned to either the training (n = 10) or control (n = 10) group. Women from the training group performed unilateral isometric handgrip sessions for 8 weeks (4 × 2 min at 25% of maximal voluntary contraction [MVC]; 3 days/week). Cardiovascular reactivity to acute isometric exercise and MVC were measured at baseline. Resting BP was assessed during and after the intervention.
RESULTS


Resting systolic BP significantly lowered only in the training group. The change in resting systolic BP following an 8-week intervention was significantly associated with the systolic BP and diastolic BP reactivity to the acute exercise at baseline during set 3 and 4 ( P  <.05). The handgrip MVC was associated with changes in systolic BP (r = 0.79,  P  =.007), diastolic BP (r = 0.68,  P  =.032), and mean arterial pressure (r = 0.79,  P  =.006). These results indicated that high cardiovascular reactivity and strength attenuate the hypotensive effects following isometric training in young women.
CONCLUSIONS


The hypotensive effects following isometric training may be identified by BP reactivity to acute isometric exercise or handgrip strength in young women.",2020,The change in resting systolic BP following an 8-week intervention was significantly associated with the systolic BP and diastolic BP reactivity to the acute exercise at baseline during set 3 and 4 ( P  <.05).,"['young women', 'twenty young women']","['unilateral isometric handgrip sessions', 'isometric training', 'acute isometric exercise', 'Isometric resistance training', 'isometric handgrip training']","['resting systolic BP', 'hypotensive effects', 'diastolic BP', 'Resting BP', 'systolic BP', 'mean arterial pressure', 'resting blood pressure (BP', 'Resting systolic BP', 'systolic BP and diastolic BP reactivity']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",20.0,0.0406729,The change in resting systolic BP following an 8-week intervention was significantly associated with the systolic BP and diastolic BP reactivity to the acute exercise at baseline during set 3 and 4 ( P  <.05).,"[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Yamagata', 'Affiliation': ""Department of Clothing, Faculty of Human Sciences and Design, Japan Women's University , Tokyo, Japan.""}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Sako', 'Affiliation': ""Department of Food and Nutrition, Faculty of Human Sciences and Design, Japan Women's University , Tokyo, Japan.""}]","Clinical and experimental hypertension (New York, N.Y. : 1993)",['10.1080/10641963.2020.1747482']
579,32249621,Cost-effectiveness of once weekly carfilzomib 70 mg/m2 plus dexamethasone in patients with relapsed and refractory multiple myeloma in the United States.,"BACKGROUND


In the US, carfilzomib 70 mg⁄m 2  once-weekly plus dexamethasone (Kd70 QW) was recently indicated for relapsed and/or refractory multiple myeloma. In current US clinical practice, most patients treated with Kd receive carfilzomib at a previously approved dose of 27 mg/m 2  twice-weekly (Kd27 BIW). This analysis assessed the cost-effectiveness (CE) of Kd70 QW vs Kd27 BIW regimens which were compared in the randomized phase 3 ARROW trial.
METHODS


Based on clinical outcomes (overall survival and utilities) from ARROW, a partitioned survival model was developed to estimate life years (LYs) and quality-adjusted life years (QALYs). Long-term survival was extrapolated using SEER registry data matched to ARROW patients. Costs were estimated using a US healthcare payer perspective.
RESULTS


The analysis estimated that treatment with Kd70 QW vs Kd27 BIW resulted in an increase of 1.10 LYs, 0.91 QALYs, and additional lifetime costs of $74,858, yielding an incremental CE ratio (ratio of incremental costs to QALYs) of $82,257 per QALY gained. Results were robust to sensitivity and subgroup analyses.
CONCLUSIONS


When compared with Kd27 BIW, Kd70 QW is the optimal dose that represents a cost-effective utilization of health care budget with incremental CE ratios well below the accepted willingness-to-pay thresholds in the US.",2020,"The analysis estimated that treatment with Kd70 QW vs Kd27 BIW resulted in an increase of 1.10 LYs, 0.91 QALYs, and additional lifetime costs of $74,858, yielding an incremental CE ratio (ratio of incremental costs to QALYs) of $82,257 per QALY gained.",['patients with relapsed and refractory multiple myeloma in the United States'],"[' ', 'dexamethasone (Kd70 QW', 'Kd27 BIW, Kd70 QW', 'Kd70 QW vs Kd27 BIW', 'carfilzomib 70 mg/m2 plus dexamethasone']","['additional lifetime costs', 'cost-effectiveness (CE', 'estimate life years (LYs) and quality-adjusted life years (QALYs', 'incremental CE ratio', 'Cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2001856', 'cui_str': 'carfilzomib'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.144455,"The analysis estimated that treatment with Kd70 QW vs Kd27 BIW resulted in an increase of 1.10 LYs, 0.91 QALYs, and additional lifetime costs of $74,858, yielding an incremental CE ratio (ratio of incremental costs to QALYs) of $82,257 per QALY gained.","[{'ForeName': 'Shaji K', 'Initials': 'SK', 'LastName': 'Kumar', 'Affiliation': 'Division of Hematology, Mayo Clinic , Rochester, MN, USA.'}, {'ForeName': 'Istvan', 'Initials': 'I', 'LastName': 'Majer', 'Affiliation': 'Global Health Economics, Amgen (Europe) GmbH , Rotkreuz, Switzerland.'}, {'ForeName': 'Sumeet', 'Initials': 'S', 'LastName': 'Panjabi', 'Affiliation': 'Global Health Economics, Amgen , South San Francisco, CA, USA.'}, {'ForeName': 'Rohan', 'Initials': 'R', 'LastName': 'Medhekar', 'Affiliation': 'Global Health Economics, Amgen , Thousand Oaks, CA, USA.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Campioni', 'Affiliation': 'Global Health Economics, Amgen , Thousand Oaks, CA, USA.'}, {'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'School of Medicine, National and Kapodistrian University of Athens, Alexandra Hospital , Athens, Greece.'}]",Expert review of hematology,['10.1080/17474086.2020.1746639']
580,32244283,Mediation Effect of Age Category on the Relationship between Body Composition and the Physical Fitness Profile in Youth Handball Players.,"The aims of the present study were (1) to determine the differences in body composition and the physical and physiological profile of handball youths across age categories, and (2) to analyze the mediation effect of different categories on the relationship between lean mass or fat mass and specific physical handball capacities. Fifty-four young handball players aged 13 to 18 were assigned to U14 (13- and 14-year-olds), U16 (15- and 16-year-olds), and U18 (17- and 18-year-olds). Body composition was measured using multi-frequency bioelectrical impedance (Inbody®, 230). Handball physical fitness was assessed using handgrip force, jumping tests (squat jump, countermovement jump, countermovement jump with aimed arms), a 30-m sprint, a change-of-direction test (T-half agility test and modified Illinois test), and a Yo-Yo intermittent recovery test level 1. Simple mediation analysis was performed to analyze whether the category mediated the relationship between lean mass or fat mass and physical capacities. No significant differences were observed according to category for the majority of the measured parameters, except for height, lean body mass, and arm span. Lean body mass increased significantly as player category increased ( p  < 0.05;  ∆  = 4.66-9.38; effect size (ES) = 0.96-1.92). The increase in handball category enhanced the majority of the physical capacities evaluated; however, these differences were reduced between the U16 vs. U18 categories. The indirect mediation effect suggests that handball category mediated the relationship between lean mass and upper and lower strength, velocity, agility, and cardiorespiratory fitness. In contrast, an indirect effect suggests that category mediated the relationship between fat mass only in agility and cardiorespiratory fitness. We conclude that U18s showed better body composition parameters, as well as better physical performance scores. Handball category clearly mediated the relationship between body composition through lean mass and fat mass and the physiological profile in handball youth, but lean mass proved to be more relevant when mediating physical performance.",2020,Lean body mass increased significantly as player category increased ( p  < 0.05;  ∆  = 4.66-9.38; effect size (ES) = 0.96-1.92).,"['Fifty-four young handball players aged 13 to 18 were assigned to U14 (13- and 14-year-olds), U16 (15- and 16-year-olds), and U18 (17- and 18-year-olds', 'Youth Handball Players']",[],"['height, lean body mass, and arm span', 'Body composition', 'lean mass and upper and lower strength, velocity, agility, and cardiorespiratory fitness', 'Handball physical fitness', 'Lean body mass', 'physical performance scores', 'body composition parameters', 'player category']","[{'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0336936', 'cui_str': 'Handball'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]",[],"[{'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C2734068', 'cui_str': 'Arm span'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0336936', 'cui_str': 'Handball'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0556113,Lean body mass increased significantly as player category increased ( p  < 0.05;  ∆  = 4.66-9.38; effect size (ES) = 0.96-1.92).,"[{'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Molina-López', 'Affiliation': 'Faculty of Education, Psychology and Sport Sciences, University of Huelva, Avda. Tres de Marzo, s/n, 21071 Huelva, Spain.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Barea Zarzuela', 'Affiliation': 'Faculty of Education, Psychology and Sport Sciences, University of Huelva, Avda. Tres de Marzo, s/n, 21071 Huelva, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Sáez-Padilla', 'Affiliation': 'Faculty of Education, Psychology and Sport Sciences, University of Huelva, Avda. Tres de Marzo, s/n, 21071 Huelva, Spain.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Tornero-Quiñones', 'Affiliation': 'Faculty of Education, Psychology and Sport Sciences, University of Huelva, Avda. Tres de Marzo, s/n, 21071 Huelva, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Planells', 'Affiliation': 'Institute of Nutrition and Food Technology, Biomedical Research Center, Health Sciences Technological Park, University of Granada, 18010 Granada, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17072350']
581,31859121,Shared decision-making and patient engagement program during acute exacerbation of COPD hospitalization: A randomized control trial.,"OBJECTIVE


To evaluate the effectiveness of a shared decision-making and patient engagement (SDM-PE) program concerning in-hospital stay during acute exacerbation of COPD and determine its impact on patients' perceived health status.
METHODS


Patients were randomly allocated to a control group that received standard treatment or an intervention group that received an individualized SDM-PE program in addition to standard treatment. The SDM-PE program included personalized health care focused on information about the disease, healthcare management, and reinforcement of behaviors regarding nutrition and exercise taking into account patients' preferences.
RESULTS


A comparative analysis between groups showed a significant improvement in perceived health status at discharge in patients included in the experimental group compared to those in the control group (60.28 ± 21.65 vs. 54.13 ± 22.69, p = 0.036). In addition, perceived health status, COPD knowledge, adherence to pharmacological treatment, general functionality, and healthy lifestyle measures were significantly better at 3-month follow-up in the intervention group.
CONCLUSION


An SDM-PE program significantly enhanced all the clinical measures assessed during hospitalization at 3-month follow-up.
PRACTICE IMPLICATIONS


COPD patients and professionals need to work together to select the best care and treatment model for patients, taking into account individual values and preferences.",2020,"A comparative analysis between groups showed a significant improvement in perceived health status at discharge in patients included in the experimental group compared to those in the control group (60.28 ± 21.65 vs. 54.13 ± 22.69, p = 0.036).","['Patients', 'acute exacerbation of COPD hospitalization']","['individualized SDM-PE program in addition to standard treatment', 'shared decision-making and patient engagement (SDM-PE) program']","['perceived health status, COPD knowledge, adherence to pharmacological treatment, general functionality, and healthy lifestyle measures', 'perceived health status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease (disorder)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]","[{'cui': 'C0643808', 'cui_str': 'SDM'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C3508152', 'cui_str': 'Patient Engagement'}]","[{'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.0366075,"A comparative analysis between groups showed a significant improvement in perceived health status at discharge in patients included in the experimental group compared to those in the control group (60.28 ± 21.65 vs. 54.13 ± 22.69, p = 0.036).","[{'ForeName': 'María', 'Initials': 'M', 'LastName': 'Granados-Santiago', 'Affiliation': 'Faculty of Health Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Marie Carmen', 'Initials': 'MC', 'LastName': 'Valenza', 'Affiliation': 'Faculty of Health Sciences, University of Granada, Granada, Spain. Electronic address: cvalenza@ugr.es.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'López-López', 'Affiliation': 'Faculty of Health Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Prados-Román', 'Affiliation': 'Faculty of Health Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Rodríguez-Torres', 'Affiliation': 'Faculty of Health Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Cabrera-Martos', 'Affiliation': 'Faculty of Health Sciences, University of Granada, Granada, Spain.'}]",Patient education and counseling,['10.1016/j.pec.2019.12.004']
582,32044192,Effects of a tailored inhaler use education program for chronic obstructive pulmonary disease patients.,"OBJECTIVES


This study compared the effects of a tailored inhaler use education program with routine clinical practice in asthma and chronic obstructive pulmonary disease patients treated with inhalers.
METHODS


The participants included 59 patients from a ≥900-bed university hospital in J city. Participants were divided into two groups and received either the tailored inhaler use education program (n = 29) or routine clinical care (n = 30). Disease knowledge and correct inhaler use were assessed using a questionnaire and observational checklists at admission and discharge. Chi-square and Mann-Whitney U tests were used for data analysis.
RESULTS


Disease knowledge (asthmaz = -2.69, p = .007; chronic obstructive pulmonary disease z = -6.08, p < .001) and correct inhaler use (z = -5.51, p < .001) were significantly higher in the tailored inhaler use education program group compared to the control group.
CONCLUSIONS


Nurses play a pivotal role in educating patients. Our results indicate that nurses are needed to identify diseases and inhaler types and to provide patients with individually tailored education that includes demonstration and feedback.
PRACTICE IMPLICATIONS


One-on-one health literacy education tailored to inhaler type and patient age shows promise for chronic disease interventions provided by nurses, physicians, and pharmacists--all the parties involved in patient care.",2020,Participants were divided into two groups and received either the tailored inhaler use education program (n = 29) or routine clinical care (n = 30).,"['participants included 59 patients from a ≥900-bed university hospital in J city', 'asthma and chronic obstructive pulmonary disease patients treated with inhalers', 'chronic obstructive pulmonary disease patients']","['tailored inhaler use education program', 'Chi-square and Mann-Whitney', 'tailored inhaler use education program (n = 29) or routine clinical care']","['chronic obstructive pulmonary disease z', 'correct inhaler use']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}]","[{'cui': 'C0021461', 'cui_str': 'Inhalators'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C1720589', 'cui_str': 'Greek letter chi'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",59.0,0.0360228,Participants were divided into two groups and received either the tailored inhaler use education program (n = 29) or routine clinical care (n = 30).,"[{'ForeName': 'Yu Mi', 'Initials': 'YM', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, Gyeongsang National University Hospital, Jinju, South Korea.'}, {'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'College of Nursing, Institute of Health Sciences, Gyeongsang National University, Jinju, South Korea. Electronic address: yumi825@gnu.ac.kr.'}, {'ForeName': 'Hye Ri', 'Initials': 'HR', 'LastName': 'Moon', 'Affiliation': 'Department of Nursing, Gyeongsang National University Hospital, Jinju, South Korea.'}, {'ForeName': 'Sun Young', 'Initials': 'SY', 'LastName': 'Ju', 'Affiliation': 'Department of Nursing, Gyeongsang National University Hospital, Jinju, South Korea.'}, {'ForeName': 'Gyeong Ae', 'Initials': 'GA', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, Gyeongsang National University Hospital, Jinju, South Korea.'}, {'ForeName': 'Min Jin', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, Gyeongsang National University Hospital, Jinju, South Korea.'}]",Patient education and counseling,['10.1016/j.pec.2020.02.005']
583,32120316,"Effects of synbiotic supplementation on microbiota-derived protein-bound uremic toxins, systemic inflammation, and biochemical parameters in patients on hemodialysis: A double-blind, placebo-controlled, randomized clinical trial.","OBJECTIVES


The generation of key nephrovascular protein-bound uremic toxins, indoxyl sulfate and phenol, in hemodialysis (HD) patients is attributed to the dysbiotic gut microbiota. The aim of this study was to investigate the effects of synbiotic supplementation on serum levels of indoxyl sulfate, phenol, inflammation, and biochemical parameters in HD patients.
METHODS


Forty-two HD patients (synbiotic group: n = 21; placebo group: n = 21) were analyzed in this randomized, double-blind, placebo-controlled study. During a 2-mo intervention, the synbiotic group received two synbiotic capsules daily, between the main meals, whereas the placebo group received maltodextrin as the placebo. Blood pressure, uremic factors, and biochemical parameters were assessed before the start and after the end of the study.
RESULTS


After adjustment for potential confounders, there was no significant effect of synbiotic on serum levels of urea, creatinine, liver enzymes, high-sensitivity C-reactive protein, sodium, potassium, phosphorus, blood pressure, or albumin in the treatment group compared with the placebo group. A significant increase in indoxyl sulfate and parathyroid hormone levels were observed only in the treatment group. However, between-group analyses were not significant. Compared with baseline values, phenol levels were decreased in both groups (P≤001), with no significant between-group difference.
CONCLUSIONS


Synbiotic supplementation might increase indoxyl sulfate and parathyroid hormone levels in HD patients.",2020,"Compared with baseline values, phenol levels were decreased in both groups (P≤001), with no significant between-group difference.
","['group: n\xa0=\xa021', 'hemodialysis (HD) patients', 'patients on hemodialysis', 'Forty-two HD patients (synbiotic group: n\xa0=\xa021', 'HD patients']","['placebo', 'synbiotic supplementation', 'Synbiotic supplementation', 'maltodextrin as the placebo']","['serum levels of indoxyl sulfate, phenol, inflammation, and biochemical parameters', 'serum levels of urea, creatinine, liver enzymes, high-sensitivity C-reactive protein, sodium, potassium, phosphorus, blood pressure, or albumin', 'Blood pressure, uremic factors, and biochemical parameters', 'phenol levels', 'indoxyl sulfate and parathyroid hormone levels']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021210', 'cui_str': 'Indoxyl Sulfate'}, {'cui': 'C0031428', 'cui_str': 'Phenols'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0070525', 'cui_str': 'phenacemide'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}]",42.0,0.253322,"Compared with baseline values, phenol levels were decreased in both groups (P≤001), with no significant between-group difference.
","[{'ForeName': 'Soheila', 'Initials': 'S', 'LastName': 'Mirzaeian', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Saraf-Bank', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohammad Hassan', 'Initials': 'MH', 'LastName': 'Entezari', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: entezari@hlth.mui.ac.ir.'}, {'ForeName': 'Azita', 'Initials': 'A', 'LastName': 'Hekmatdoost', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology, Research Institute Shahid Beheshti University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Awat', 'Initials': 'A', 'LastName': 'Feizi', 'Affiliation': 'Department of Epidemiology and Biostatistics, Faculty of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Abdolamir', 'Initials': 'A', 'LastName': 'Atapour', 'Affiliation': 'Isfahan Kidney diseases research center, Department of Nephrology, Isfahan University of Medical Sciences, Isfahan, Iran.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2019.110713']
584,31392559,"Effects of coenzyme Q10 supplementation on matrix metalloproteinases and DAS-28 in patients with rheumatoid arthritis: a randomized, double-blind, placebo-controlled clinical trial.","OBJECTIVES


This study aimed to assess the effect of CoQ10 supplementation on serum matrix metalloproteinases (MMPs) and clinical parameters in rheumatoid arthritis (RA) patients.
METHOD


In this randomized, double-blind, placebo-controlled trial, 54 RA patients who fulfilled the eligibility criteria (18-56 years, diagnosed at least 6 months ago, with DAS-28 > 3.2) were randomly assigned into two groups to receive 100 mg/day CoQ10 (n = 27) or placebo (n = 27) for 2 months. Serum MMP-1 and MMP-3 levels and clinical status using disease activity score in 28 joints (DAS-28) were assessed before and after supplementation. Data were analyzed using χ2, independent sample t test, paired t test, Wilcoxon, Mann-Whitney, and analysis of covariance.
RESULTS


A significant reduction was observed in both CoQ10 and placebo groups in the medians of serum MMP-1 (0.2 to 0.16, P < 0.001), (0.18 to 0.15, P = 0.001); swollen joint count (2 to 0, P < 0.001), (2 to 0, P = 0.009); and the means of DAS-28 (5.01 ± 1.21 to 2.34 ± 0.68, P < 0.001), (4.88 ± 0.96 to 4.04 ± 1.36, P = 0.009) respectively. Serum MMP-3 level increased significantly in placebo group (2.26 to 2.57, P = 0.020), and the MMP-3 changes between groups were significant (P = 0.027). Furthermore, significant reductions were only observed in ESR, pain score, and tender joint count in CoQ10 group compared with baseline (P = 0.001, P < 0.001, and P < 0.001, respectively). Significant differences were observed between two groups in DAS-28, pain score, and swollen and tender joint count after the intervention (P < 0.001, P < 0.001, and P = 0.012 and P < 0.001, respectively).
CONCLUSIONS


It seems that CoQ10 may provide a new complementary approach for RA patients.Key Points• CoQ10 supplementation in RA patients attenuated serum MMP-3 level.• CoQ10 supplementation in RA patients improved clinical outcomes and ameliorated disease severity.• CoQ10 may provide a new complementary approach for patients with RA.",2019,"Significant differences were observed between two groups in DAS-28, pain score, and swollen and tender joint count after the intervention (P < 0.001, P < 0.001, and P = 0.012 and P < 0.001, respectively).
","['54 RA patients who fulfilled the eligibility criteria (18-56\xa0years, diagnosed at least 6\xa0months ago, with DAS-28\u2009>\u20093.2', 'patients with RA', 'rheumatoid arthritis (RA) patients', 'patients with rheumatoid arthritis']","['100\xa0mg/day CoQ10', 'placebo', 'CoQ10 supplementation', 'coenzyme Q10 supplementation', 'CoQ10']","['ESR, pain score, and tender joint count', 'swollen joint count', 'clinical outcomes and ameliorated disease severity', 'serum MMP-1', 'MMP-3 changes', 'DAS-28, pain score, and swollen and tender joint count', 'Serum MMP-3 level', 'serum MMP-3 level', 'matrix metalloproteinases and DAS-28', 'Serum MMP-1 and MMP-3 levels and clinical status using disease activity score', 'serum matrix metalloproteinases (MMPs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0051767', 'cui_str': 'DASD'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}]","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0056077', 'cui_str': 'coenzyme Q10'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0451530', 'cui_str': 'Tender joint count (assessment scale)'}, {'cui': 'C0451521', 'cui_str': 'Swollen joint count (assessment scale)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0051767', 'cui_str': 'DASD'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449440', 'cui_str': 'Clinical status (attribute)'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}]",,0.522653,"Significant differences were observed between two groups in DAS-28, pain score, and swollen and tender joint count after the intervention (P < 0.001, P < 0.001, and P = 0.012 and P < 0.001, respectively).
","[{'ForeName': 'Seyed Mostafa', 'Initials': 'SM', 'LastName': 'Nachvak', 'Affiliation': 'Department of Nutritional Sciences, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Beitollah', 'Initials': 'B', 'LastName': 'Alipour', 'Affiliation': 'Department of Community Nutrition, Faculty of Nutrition, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Aida Malek', 'Initials': 'AM', 'LastName': 'Mahdavi', 'Affiliation': 'Connective Tissue Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mir Amir', 'Initials': 'MA', 'LastName': 'Aghdashi', 'Affiliation': 'Department of Rheumatology, Faculty of Medicine, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Abdollahzad', 'Affiliation': 'Department of Nutritional Sciences, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran. hadi_nut@yahoo.com.'}, {'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Pasdar', 'Affiliation': 'Department of Nutritional Sciences, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Mehnoosh', 'Initials': 'M', 'LastName': 'Samadi', 'Affiliation': 'Department of Nutritional Sciences, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Roghayeh', 'Initials': 'R', 'LastName': 'Mostafai', 'Affiliation': 'Department of Nutritional Sciences, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}]",Clinical rheumatology,['10.1007/s10067-019-04723-x']
585,32244681,Beyond the Wall: Death Education at Middle School as Suicide Prevention.,"This study investigates the psychological effects of participation in Death Education (DeEd) by middle school children in two towns in northeast Italy in which suicides occur to a greater extent than in the rest of the region. The aims of the project ""Beyond the Wall"" were inherent to the prevention of suicide, address existential issues and enhance the meaning of life through positive intentions for the future and reflection on mortality. It involved eight classes (150 students in four classes in the experimental group; 81 in four classes in the control group) engaging with films, workgroup activities, photovoice and psychodrama. The constructs of resilience, emotional competency and psychological well-being were monitored with the Resilience Scale for Adolescents, the Hopelessness Scale for Children, the Alexithymia Questionnaire for Children and the Stirling Children's Well-being Scale. The DeEd intervention was found to be significantly related to some of the variables investigated, improving the students' ability to recognise emotions and communicate them verbally while maintaining stable initial characteristics, such as psychological well-being and positive expectations for the future.",2020,"The DeEd intervention was found to be significantly related to some of the variables investigated, improving the students' ability to recognise emotions and communicate them verbally while maintaining stable initial characteristics, such as psychological well-being and positive expectations for the future.","['middle school children in two towns in northeast Italy in which suicides occur to a greater extent than in the rest of the region', 'It involved eight classes (150 students in four classes in the experimental group; 81 in four classes in the control group) engaging with films, workgroup activities, photovoice and psychodrama']",[],[],"[{'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205454', 'cui_str': '8'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0033889', 'cui_str': 'Psychodrama'}]",[],[],,0.0207227,"The DeEd intervention was found to be significantly related to some of the variables investigated, improving the students' ability to recognise emotions and communicate them verbally while maintaining stable initial characteristics, such as psychological well-being and positive expectations for the future.","[{'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Testoni', 'Affiliation': 'Department of Philosophy, Sociology, Education and Applied Psychology (FISPPA), University of Padova, Via Venezia 14, 35131 Padua, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Tronca', 'Affiliation': 'Department of Philosophy, Sociology, Education and Applied Psychology (FISPPA), University of Padova, Via Venezia 14, 35131 Padua, Italy.'}, {'ForeName': 'Gianmarco', 'Initials': 'G', 'LastName': 'Biancalani', 'Affiliation': 'Department of Philosophy, Sociology, Education and Applied Psychology (FISPPA), University of Padova, Via Venezia 14, 35131 Padua, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Ronconi', 'Affiliation': 'Department of Philosophy, Sociology, Education and Applied Psychology (FISPPA), University of Padova, Via Venezia 14, 35131 Padua, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Calapai', 'Affiliation': 'Alma.Thi Association, 36016 Thiene, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17072398']
586,31926658,Comparative study of different epidural infusion sets at maximum speeds for labor analgesia.,"INTRODUCTION


The higher injection pressure obtained with epidural boluses give greater anaesthetic spread, and therefore better sensory block. Therefore, it stands to reason that anaesthetic administered at greater injection pressure and a higher flow rate would spread to a higher sensory level.
OBJECTIVE


Our aim was to compare the sensory level reached with the high flow. and standard flow set at maximum rates.
MATERIAL AND METHODS


We included 73 primiparous women who requested epidural analgesia for labour using programmed intermittent epidural boluses of 0.1% ropivacaine at a flow rate of 10ml/h and 2 ug/ml fentanyl plus patient-controlled epidural analgesia. The boluses were administered with a standard (250ml/h) or high-flow (500ml/h) infusion set, according to the usual clinical practice of each anaesthesiologist. The primary objective was to evaluate the sensory level reached. Secondary objectives were pain on a visual analogue scale, motor block measured on the modified Bromage scale, and anaesthesia consumption in terms of rescue analgesia (patient-controlled epidural analgesia) and anaesthesiologist-administered boluses.
RESULTS


The median maximum sensory level reached was T9 in the high flow group and T7 in the standard flow group; this difference was statistically significant (p=.0002). There were no significant differences in visual analogue scale, Bromage or rescue analgesia between groups.
CONCLUSION


Our results show that the high flow set does not offer benefits. The use of such sets need to be evaluated due to their higher cost.",2020,"There were no significant differences in visual analogue scale, Bromage or rescue analgesia between groups.
",['73 primiparous women who requested epidural analgesia for labour using programmed intermittent epidural boluses of 0.1'],['ropivacaine at a flow rate of 10ml/h and 2 ug/ml fentanyl plus patient-controlled epidural analgesia'],"['median maximum sensory level', 'visual analogue scale, Bromage or rescue analgesia', 'pain on a visual analogue scale, motor block measured on the modified Bromage scale, and anaesthesia consumption in terms of rescue analgesia (patient-controlled epidural analgesia) and anaesthesiologist-administered boluses', 'sensory level']","[{'cui': 'C0033150', 'cui_str': 'Primiparity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0002769', 'cui_str': 'Analgesia, Epidural'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0439268', 'cui_str': 'microgram/mL'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1301707', 'cui_str': 'Patient controlled epidural analgesia'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1262068', 'cui_str': 'Sensory level'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1301887', 'cui_str': 'Bromage scale'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1301707', 'cui_str': 'Patient controlled epidural analgesia'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C1621583', 'cui_str': 'Administer'}]",,0.0806912,"There were no significant differences in visual analogue scale, Bromage or rescue analgesia between groups.
","[{'ForeName': 'M Á', 'Initials': 'MÁ', 'LastName': 'Darás Orenga', 'Affiliation': 'Servicio de Anestesiología, Reanimación y Terapéutica del dolor, Hospital Universitario La Plana Villarreal, Castellón, España. Electronic address: orenga1979@gmail.com.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gellida Vilarroig', 'Affiliation': 'Servicio de Anestesiología, Reanimación y Terapéutica del dolor, Hospital General Universitario de Castellón, Castellón, España.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Vives Piqueres', 'Affiliation': 'Servicio de Anestesiología, Reanimación y Terapéutica del dolor, Hospital Universitario La Plana Villarreal, Castellón, España.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sanz García', 'Affiliation': 'Servicio de Anestesiología, Reanimación y Terapéutica del dolor, Hospital Arnau de Vilanova.'}, {'ForeName': 'R T', 'Initials': 'RT', 'LastName': 'Inoges', 'Affiliation': 'Servicio de Anestesiología, Reanimación y Terapéutica del dolor, Hospital Universitario La Plana Villarreal, Castellón, España.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nicolau Gozalbo', 'Affiliation': 'Servicio de Anestesiología, Reanimación y Terapéutica del dolor, Hospital Universitario La Plana Villarreal, Castellón, España.'}]",Revista espanola de anestesiologia y reanimacion,['10.1016/j.redar.2019.11.004']
587,32245745,Long term skeletal and dental changes between tooth-anchored versus Dresden bone-anchored rapid maxillary expansion using CBCT images in adolescents: Randomized clinical trial.,"OBJECTIVE


The aim of this study was to determine long-term skeletal and dental changes in tooth-anchored versus Dresden bone-anchored rapid maxillary expansion using CBCT images in adolescents.
MATERIALS AND METHODS


In all, 29 adolescent patients (11-17 years of age) needing skeletal expansion were randomly allocated to two different groups treated by either a Dresden bone-anchored expander or a conventional hyrax expander. Patients included did not have previous orthodontic treatment, were non-syndromic and had all teeth present in mouth. CBCT images were taken before expansion and two or more years after expansion. An independent T-test was used to determine the statistical significance between treatment groups and paired T-test was used to compare the results before and after expansion in each group.
RESULTS


Neither treatment group showed overall long-term different skeletal and dental changes in the transverse, anterior-posterior and vertical planes (P<0.05). Both treatment groups showed mild asymmetric skeletal expansion, but these were clinically insignificant.
CONCLUSIONS


Both expanders had similar skeletal and dental results. The greatest changes were in the transverse plane. Changes in vertical and anterior-posterior were negligible.",2020,"Neither treatment group showed overall long-term different skeletal and dental changes in the transverse, anterior-posterior and vertical planes (P<0.05).","['29 adolescent patients (11-17 years of age) needing skeletal expansion', 'adolescents', 'Patients included did not have previous orthodontic treatment, were non-syndromic and had all teeth present in mouth']",['Dresden bone-anchored expander or a conventional hyrax expander'],"['overall long-term different skeletal and dental changes', 'mild asymmetric skeletal expansion']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}, {'cui': 'C0457755', 'cui_str': 'Tooth presence - finding'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C1720978', 'cui_str': 'Bone Anchors'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0020696', 'cui_str': 'Family Procaviidae'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}]",29.0,0.0890528,"Neither treatment group showed overall long-term different skeletal and dental changes in the transverse, anterior-posterior and vertical planes (P<0.05).","[{'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Davami', 'Affiliation': 'Private Practice, Isfahan, Iran.'}, {'ForeName': 'Elissa', 'Initials': 'E', 'LastName': 'Talma', 'Affiliation': 'University of Minas Gerais, Structural Engineering School, Minas Gerais, Brazil.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Harzer', 'Affiliation': 'Technical University of Dresden, department of Orthodontics, Fetscherstr. 72, D-01307 Dresden, Germany.'}, {'ForeName': 'Manuel O', 'Initials': 'MO', 'LastName': 'Lagravère', 'Affiliation': 'University of Alberta, Faculty of Medicine and Dentistry, School of Dentistry, Orthodontic Graduate Program, ECHA 5-524, 11405-87 Ave, T6G 1C9 Edmonton, AB, Canada. Electronic address: manuel@ualberta.ca.'}]",International orthodontics,['10.1016/j.ortho.2020.02.004']
588,31795041,Improved emotion regulation after neurofeedback: A single-arm trial in patients with borderline personality disorder.,"Real-time functional magnetic resonance imaging (fMRI) neurofeedback training of amygdala hemodynamic activity directly targets a neurobiological mechanism, which contributes to emotion regulation problems in borderline personality disorder (BPD). However, it remains unknown which outcome measures can assess changes in emotion regulation and affective instability, associated with amygdala downregulation in a clinical trial. The current study directly addresses this question. Twenty-four female patients with a DSM-IV BPD diagnosis underwent four runs of amygdala neurofeedback. Before and after the training, as well as at a six-weeks follow-up assessment, participants completed measures of emotion dysregulation and affective instability at diverse levels of analysis (verbal report, clinical interview, ecological momentary assessment, emotion-modulated startle, heart rate variability, and fMRI). Participants were able to downregulate their amygdala blood oxygen-dependent (BOLD) response with neurofeedback. There was a decrease of BPD symptoms as assessed with the Zanarini rating scale for BPD (ZAN-BPD) and a decrease in emotion-modulated startle to negative pictures after training. Further explorative analyses suggest that patients indicated less affective instability, as seen by lower hour-to-hour variability in negative affect and inner tension in daily life. If replicated by an independent study, our results imply changes in emotion regulation and affective instability for several systems levels, including behavior and verbal report. Conclusions are limited due to the lack of a control group. A randomized controlled trial (RCT) will be needed to confirm effectiveness of the training.",2019,There was a decrease of BPD symptoms as assessed with the Zanarini rating scale for BPD (ZAN-BPD) and a decrease in emotion-modulated startle to negative pictures after training.,"['patients with borderline personality disorder', 'borderline personality disorder (BPD', 'Twenty-four female patients with a DSM-IV BPD diagnosis underwent four runs of amygdala neurofeedback']",[],"['emotion-modulated startle to negative pictures', 'emotion regulation and affective instability', 'amygdala blood oxygen-dependent (BOLD) response with neurofeedback', 'affective instability', 'emotion dysregulation and affective instability at diverse levels of analysis (verbal report, clinical interview, ecological momentary assessment, emotion-modulated startle, heart rate variability, and fMRI', 'emotion regulation', 'Zanarini rating scale for BPD (ZAN-BPD', 'BPD symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}]",[],"[{'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0005768'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0460109', 'cui_str': 'Verbal report'}, {'cui': 'C0199182', 'cui_str': 'Taking health history'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0222045'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",24.0,0.0423346,There was a decrease of BPD symptoms as assessed with the Zanarini rating scale for BPD (ZAN-BPD) and a decrease in emotion-modulated startle to negative pictures after training.,"[{'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Zaehringer', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/University of Heidelberg, Mannheim, Germany. Electronic address: jenny.zaehringer@zi-mannheim.de.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Ende', 'Affiliation': 'Department Neuroimaging, Central Institute of Mental Health, Medical Faculty Mannheim / University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Santangelo', 'Affiliation': 'Chair of Applied Psychology/Mental Health Lab, Institute of Sport and Sports Science, Karlsruhe Institute of Technology, Karlsruhe, Germany.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Kleindienst', 'Affiliation': 'Institute of Psychiatric and Psychosomatic Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Ruf', 'Affiliation': 'Department Neuroimaging, Central Institute of Mental Health, Medical Faculty Mannheim / University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Bertsch', 'Affiliation': 'Department for General Psychiatry, Center of Psychosocial Medicine, University of Heidelberg, Heidelberg, Germany; Department of Psychology, LMU Munich, Munich, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bohus', 'Affiliation': 'Institute of Psychiatric and Psychosomatic Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schmahl', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Paret', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/University of Heidelberg, Mannheim, Germany; Sagol Brain Institute, Wohl Institute for Advanced Imaging, Tel-Aviv Sourasky Medical Center and School of Psychological Sciences, Tel-Aviv University, Tel-Aviv, Israel. Electronic address: christian.paret@zi-mannheim.de.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.102032']
589,31818522,Improving shared decision-making in advance care planning: Implementation of a cluster randomized staff intervention in dementia care.,"OBJECTIVE


Increasing staff engagement level of shared decision-making in advance care planning for persons with dementia in nursing homes. Perceived importance, competence and frequency of staff members applying shared decision-making were measured. Additionally, facilitators and barriers in the implementation process were described.
METHODS


In this pretest-posttest cluster randomized trial, 311 staff members from 65 Belgian nursing home wards participated. Key components of the intervention were knowledge on shared decision-making, role-play exercises and internal policies on advance care planning. Audio recordings of advance care planning conversations between residents, families and staff were compared before and after the intervention. Participants filled in questionnaires and provided feedback.
RESULTS


Wards demonstrated a higher level of shared decision-making after the intervention (p < 0.001) while time spent on the conversations did not increase. This effect persisted at 6 months follow-up (p < 0.001). Participants perceived shared decision-making as more important (p = 0.031) and felt more competent (p = 0.010), though frequency of use did not change (p = 0.201). High staff turnover and difficult co-operation with GP's were barriers.
CONCLUSION


Nursing home staff benefits from this training in shared decision-making.
PRACTICE IMPLICATIONS


Learning shared decision-making in advance care planning for persons with dementia is possible and sustainable in the time-constricted context of nursing homes.",2020,"RESULTS


Wards demonstrated a higher level of shared decision-making after the intervention (p < 0.001) while time spent on the conversations did not increase.","['persons with dementia in nursing homes', '311 staff members from 65 Belgian nursing home wards participated', 'persons with dementia']",[],['higher level of shared decision-making'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0337797', 'cui_str': 'Belgians'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}]",311.0,0.0302971,"RESULTS


Wards demonstrated a higher level of shared decision-making after the intervention (p < 0.001) while time spent on the conversations did not increase.","[{'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Goossens', 'Affiliation': 'LUCAS - Centre for Care Research & Consultancy, KU Leuven, Minderbroedersstraat 8, Postal Box 5310, 3000, Leuven, Belgium. Electronic address: bart.goossens@kuleuven.be.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Sevenants', 'Affiliation': 'LUCAS - Centre for Care Research & Consultancy, KU Leuven, Minderbroedersstraat 8, Postal Box 5310, 3000, Leuven, Belgium; Academic Center for General Practice, KU Leuven, Kapucijnenvoer 33j, Postal Box 7001, 3000, Leuven, Belgium. Electronic address: aline.sevenants@kuleuven.be.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Declercq', 'Affiliation': 'LUCAS - Centre for Care Research & Consultancy, KU Leuven, Minderbroedersstraat 8, Postal Box 5310, 3000, Leuven, Belgium; Centre for Sociological Research, KU Leuven, Parkstraat 45, Postal Box 3601, 3000, Leuven, Belgium. Electronic address: anja.declercq@kuleuven.be.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Van Audenhove', 'Affiliation': 'LUCAS - Centre for Care Research & Consultancy, KU Leuven, Minderbroedersstraat 8, Postal Box 5310, 3000, Leuven, Belgium; Academic Center for General Practice, KU Leuven, Kapucijnenvoer 33j, Postal Box 7001, 3000, Leuven, Belgium. Electronic address: chantal.vanaudenhove@kuleuven.be.'}]",Patient education and counseling,['10.1016/j.pec.2019.11.024']
590,32065880,Change of some oxidative stress parameters after supplementation with whey protein isolate in patients with type 2 diabetes.,"OBJECTIVES


The aim of this study was to evaluate the effects of undenatured whey protein isolate (WPI; ≥92.5%) with a high content of native cysteine (2.7%) and a standardized content of lactoferrin (≥0.7%) on parameters related to oxidative stress and inflammation in individuals with type 2 diabetes mellitus.
METHODS


We assigned 120 white patients with type 2 diabetes and glycated hemoglobin ≥6.5% to two groups. The patients were supplemented daily with WPI or placebo for 3 mo. After 3 mo, the markers of oxidation (superoxide dismutase, glutathione peroxidase, glutathione, and reduced glutathione-to-oxidized glutathione ratio) and inflammation (high sensitivity C-reactive protein, interleukin-6, tumor necrosis factor -α, malondialdehyde) were significantly lower in the WPI group than in the placebo group (P < 0.05). The WPI group obtained a significant improvement in the lipid profile and a reduction in fasting plasma glucose compared with baseline and placebo (P < 0.05). No variations of body weight, body mass index or circumferences and metalloproteinase-2 and -9, or soluble receptor for advanced glycation end product were recorded in either groups.
CONCLUSION


Supplementation with WPI may be useful in patients with diabetes to control fasting glycemia. Moreover, it can help to improve inflammatory and oxidative stress, which play a crucial role in the development of diabetes complications and also in the progression of other chronic diseases.",2020,The WPI group obtained a significant improvement in the lipid profile and a reduction in fasting plasma glucose compared with baseline and placebo (P < 0.05).,"['individuals with type 2 diabetes mellitus', '120 white patients with type 2 diabetes and glycated hemoglobin ≥6.5% to two groups', 'patients with type 2 diabetes', 'patients with diabetes to control fasting glycemia']","['WPI or placebo', 'lactoferrin', 'placebo']","['fasting plasma glucose', 'body weight, body mass index or circumferences and metalloproteinase-2 and -9, or soluble receptor for advanced glycation end product', 'lipid profile', 'markers of oxidation (superoxide dismutase, glutathione peroxidase, glutathione, and reduced glutathione-to-oxidized glutathione ratio) and inflammation (high sensitivity C-reactive protein, interleukin-6, tumor necrosis factor -α, malondialdehyde', 'oxidative stress and inflammation']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0025543', 'cui_str': 'Metalloproteases'}, {'cui': 'C0101725', 'cui_str': 'Advanced Glycosylation Endproduct Receptors'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0069638', 'cui_str': 'orgotein'}, {'cui': 'C0017822', 'cui_str': 'Glutathione:hydrogen-peroxide oxidoreductase'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0034917', 'cui_str': 'Reduced Glutathione'}, {'cui': 'C0061516', 'cui_str': 'Glutathione Disulfide'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}]",120.0,0.0462421,The WPI group obtained a significant improvement in the lipid profile and a reduction in fasting plasma glucose compared with baseline and placebo (P < 0.05).,"[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Derosa', 'Affiliation': 'Centre of Diabetes and Metabolic Diseases, Department of Internal Medicine and Therapeutics, University of Pavia and Fondazione IRCCS Policlinico San Matteo, Pavia, Italy; Centre for Prevention, Surveillance, Diagnosis and Treatment of Rare Diseases, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy; Laboratory of Molecular Medicine, University of Pavia, Pavia, Italy. Electronic address: giuseppe.derosa@unipv.it.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': ""D'Angelo"", 'Affiliation': 'Centre of Diabetes and Metabolic Diseases, Department of Internal Medicine and Therapeutics, University of Pavia and Fondazione IRCCS Policlinico San Matteo, Pavia, Italy; Laboratory of Molecular Medicine, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Maffioli', 'Affiliation': 'Centre of Diabetes and Metabolic Diseases, Department of Internal Medicine and Therapeutics, University of Pavia and Fondazione IRCCS Policlinico San Matteo, Pavia, Italy; Centre for Prevention, Surveillance, Diagnosis and Treatment of Rare Diseases, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2019.110700']
591,32086111,Adherence to diet low in fermentable carbohydrates and traditional diet for irritable bowel syndrome.,"OBJECTIVES


Dietary interventions in irritable bowel syndrome (IBS) include a traditional IBS diet following the guidelines from the National Institute for Health and Clinical Excellence and a diet low in fermentable oligo-, di-, monosaccharides and polyols (FODMAPs). The aim of this study was to evaluate the adherence to these diets, food groups difficult to replace, and dietary determinants of symptom improvement.
METHODS


Sixty-six patients with IBS were randomized to a 4-wk low FODMAP or traditional IBS diet. Participants completed 4-d diet diaries before and during the intervention and reported symptoms on the IBS severity scoring system. We described adherence to the diets on the food group and product level and investigated the association between adherence and symptom improvement.
RESULTS


Adherence to the low FODMAP diet was good and consistent: All participants had a comparable shift in the diet's principal components compatible with the guidelines. Most high FODMAP products were well replaced with low FODMAP equivalents. However, total energy intake fell by 25%, mainly owing to a 69% decreased intake of snacks (P < 0.001). The traditional IBS diet did not shift the diet's principal components, and despite the guidelines, consumption of coffee and alcoholic beverages remained rather high (>50% of baseline). Total energy intake fell by 11% (P = 0.15). For both diets, there was a trend toward an association between adherence and symptom improvement (P < 0.10).
CONCLUSION


In both the low FODMAP and traditional IBS diet, certain food groups were difficult to replace. Because adherence may predict symptom improvement, close dietary guidance might enhance the efficacy of both diets.",2020,"For both diets, there was a trend toward an association between adherence and symptom improvement (P < 0.10).
","['irritable bowel syndrome', 'irritable bowel syndrome (IBS', 'Sixty-six patients with IBS']","['4-wk low FODMAP or traditional IBS diet', 'diet low in fermentable carbohydrates and traditional diet']","['adherence and symptom improvement', 'Total energy intake fell', 'total energy intake fell', '4-d diet diaries', 'intake of snacks']","[{'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C4517841', 'cui_str': 'Sixty-six'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C3494314', 'cui_str': 'Snacking'}]",66.0,0.0159959,"For both diets, there was a trend toward an association between adherence and symptom improvement (P < 0.10).
","[{'ForeName': 'Egbert', 'Initials': 'E', 'LastName': 'Clevers', 'Affiliation': 'Department of Internal Medicine & Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Translational Research Center for Gastrointestinal Disorders (TARGID), KU Leuven, Belgium.'}, {'ForeName': 'Milly', 'Initials': 'M', 'LastName': 'Tran', 'Affiliation': 'Department of Internal Medicine & Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Van Oudenhove', 'Affiliation': 'Translational Research Center for Gastrointestinal Disorders (TARGID), KU Leuven, Belgium.'}, {'ForeName': 'Stine', 'Initials': 'S', 'LastName': 'Störsrud', 'Affiliation': 'Department of Internal Medicine & Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Böhn', 'Affiliation': 'Department of Internal Medicine & Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Törnblom', 'Affiliation': 'Department of Internal Medicine & Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Simrén', 'Affiliation': 'Department of Internal Medicine & Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Center for Functional Gastrointestinal and Motility Disorders, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA. Electronic address: magnus.simren@medicine.gu.se.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110719']
592,31761525,Implementation of a health-literate patient decision aid for chest pain in the emergency department.,"OBJECTIVE


The aim of this study was to investigate the implementation of a new health-literacy-tested patient decision aid for chest pain in Emergency Department (ED) patients. Outcomes included disposition, knowledge, decisional conflict and satisfaction prior to discharge. Patient health literacy was explored as a factor that may explain disparities in sub-group analysis of all outcomes.
METHODS


A health-literacy adapted tool was deployed using a pre/post intervention design. Patients enrolled during the intervention period were given the adapted chest pain decision aid that was used in conversation with their emergency medicine physician to decide on their course of action prior to being discharged.
RESULTS


A total of 169 participants were surveyed and used in the final analysis. Patients in the usual care group were 2.6 times more likely to be admitted for chest pain than patients in the intervention group. Knowledge scores were higher in the intervention group, while no significant differences were observed in decisional conflict and patient satisfaction, or by patient health literacy level.
CONCLUSION AND PRACTICE IMPLICATIONS


Using the adapted chest pain decision tool in emergency medicine may improve knowledge and reduce admissions, while addressing known barriers to understanding related to patient health literacy.",2020,"Knowledge scores were higher in the intervention group, while no significant differences were observed in decisional conflict and patient satisfaction, or by patient health literacy level.
","['169 participants were surveyed and used in the final analysis', 'for chest pain in Emergency Department (ED) patients']","['new health-literacy-tested patient decision aid', 'adapted chest pain decision aid that was used in conversation with their emergency medicine physician to decide on their course of action prior to being discharged']","['2.6 times more likely to be admitted for chest pain', 'decisional conflict and patient satisfaction, or by patient health literacy level', 'disposition, knowledge, decisional conflict and satisfaction prior to discharge', 'Knowledge scores']","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0013964', 'cui_str': 'Emergency Medicine'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]","[{'cui': 'C4517633', 'cui_str': 'Two point six'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0743223', 'cui_str': 'Disposition (disposition)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",169.0,0.0283163,"Knowledge scores were higher in the intervention group, while no significant differences were observed in decisional conflict and patient satisfaction, or by patient health literacy level.
","[{'ForeName': 'Kristie B', 'Initials': 'KB', 'LastName': 'Hadden', 'Affiliation': 'University of Arkansas for Medical Sciences, Center for Health Literacy, Little Rock, AR 72205-7199 USA. Electronic address: khadden@uams.edu.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'McLemore', 'Affiliation': 'University of Arkansas for Medical Sciences, Department of Emergency Medicine, Little Rock, AR 72205-7199 USA. Electronic address: HHMclemore@uams.edu.'}, {'ForeName': 'Wesley', 'Initials': 'W', 'LastName': 'White', 'Affiliation': 'University of Arkansas for Medical Sciences, Department of Emergency Medicine, Little Rock, AR 72205-7199 USA. Electronic address: WWhite@uams.edu.'}, {'ForeName': 'Matthew H', 'Initials': 'MH', 'LastName': 'Marks', 'Affiliation': 'University of Arkansas for Medical Sciences, Department of Emergency Medicine, Little Rock, AR 72205-7199 USA. Electronic address: MHMarks89@gmail.com.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Gan', 'Affiliation': 'University of Arkansas for Medical Sciences, Center for Health Literacy, Little Rock, AR 72205-7199 USA. Electronic address: JGan@uams.edu.'}, {'ForeName': 'Rawle A', 'Initials': 'RA', 'LastName': 'Seupaul', 'Affiliation': 'University of Arkansas for Medical Sciences, Department of Emergency Medicine, Little Rock, AR 72205-7199 USA. Electronic address: RASeupaul@uams.edu.'}]",Patient education and counseling,['10.1016/j.pec.2019.11.009']
593,31761527,Persuasive messages can be more effective when repeated: A comparative survey assessing a message to seek help for depression among Japanese adults.,"OBJECTIVE


To examine whether a visually appealing design and/or repetition improve the effectiveness of depression help-seeking message.
METHODS


A total of 7017 Japanese adults aged 35-45 years who showed no prior help-seeking intention for depression were randomly assigned to one of three treatment groups, which was to receive a depression help-seeking message either once, twice, or never. Two weeks after the treatment, 5386 (75.8 %) completed a follow-up survey.
RESULTS


The proportions of participants who remembered reading the message differed significantly by the frequency of message exposure but not by the visual design of the message. Path analysis with structural equation modeling revealed that repeated exposure to the message had a significant effect on the elicitation of help-seeking intentions through enhanced message retention.
CONCLUSION


The depression help-seeking message can elicit the intent to do so among people who otherwise lack this. Effects of the message may depend greatly on whether or not the message is memorable and carries persuasive weight with an audience.
PRACTICAL IMPLICATIONS


Repeated message exposure may enable recipients to retain the message so that it may be used when necessary. It would be valuable to try to send messages repeatedly, with the aim of sustaining the effect of messaging over time.",2020,"Path analysis with structural equation modeling revealed that repeated exposure to the message had a significant effect on the elicitation of help-seeking intentions through enhanced message retention.
","['7017 Japanese adults aged 35-45 years who showed no prior help-seeking intention for depression', 'Japanese adults']",[],['frequency of message exposure'],"[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",[],"[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",,0.0580837,"Path analysis with structural equation modeling revealed that repeated exposure to the message had a significant effect on the elicitation of help-seeking intentions through enhanced message retention.
","[{'ForeName': 'Machi', 'Initials': 'M', 'LastName': 'Suka', 'Affiliation': 'Department of Public Health and Environmental Medicine, The Jikei University School of Medicine, 3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo, 105-8461, Japan. Electronic address: suka@jikei.ac.jp.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Yamauchi', 'Affiliation': 'Department of Public Health and Environmental Medicine, The Jikei University School of Medicine, 3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo, 105-8461, Japan. Electronic address: yamauchi-t@jikei.ac.jp.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Yanagisawa', 'Affiliation': 'Department of Public Health and Environmental Medicine, The Jikei University School of Medicine, 3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo, 105-8461, Japan. Electronic address: hryanagisawa@jikei.ac.jp.'}]",Patient education and counseling,['10.1016/j.pec.2019.11.008']
594,32193044,Etomidate plus fentanyl for anesthesia in pediatric strabotomy.,"Considering the side effects of etomidate, it requires additional anesthetics to reduce the side effects and improve efficacy. Ketamine is often used as an adjunct anesthetic. We hypothesized that etomidate combined with fentanyl was more effective than etomidate combined with ketamine in the anesthesia of pediatric strabotomy. To prove our hypothesis, a prospective randomized controlled clinical study was performed, in which 35 children with strabotomy received etomidate plus ketamine (group A) for anesthesia induction and maintenance and 35 children with strabotomy received etomidate combined with fentanyl (group B). Mean arterial pressure (MAP), heart rate (HR), bispectral index (BIS), anesthesia effect, and emergence agitation and pain were observed before anesthesia induction (T1), after anesthesia induction (T2), at the beginning of the operation (T3), after 10-min operation (T4), and at the end of the operation (T5). Children in group B had significantly lower MAP and HR from T3 to T5, decreased BIS from T2 to T4, better anesthesia effect, and smaller emergence agitation and pain scores at 10 min after entering into postanesthesia care unit (PACU) compared with group A (p < 0.05). The mean emergence agitation score in group B was significantly lower than that in group A when the maximum emergence in group B was at 20 min after entering into PACU (p < 0.05). In conclusion, etomidate combined with fentanyl plays a good efficacy in anesthesia of pediatric strabotomy compared with etomidate plus ketamine.",2020,The mean emergence agitation score in group B was significantly lower than that in group A when the maximum emergence in group B was at 20 min after entering into PACU (p < 0.05).,"['35 children with strabotomy received', 'anesthesia in pediatric strabotomy', 'group A) for anesthesia induction and maintenance and 35 children with strabotomy received']","['etomidate combined with fentanyl', 'etomidate plus ketamine', 'ketamine', 'Etomidate plus fentanyl', 'etomidate', 'Ketamine']","['mean emergence agitation score', 'anesthesia effect, and smaller emergence agitation and pain scores', 'MAP and HR', 'Mean arterial pressure (MAP), heart rate (HR), bispectral index (BIS), anesthesia effect, and emergence agitation and pain were observed before anesthesia induction (T1), after anesthesia induction (T2), at the beginning of the operation (T3']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0948673', 'cui_str': 'Strabotomy'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia (procedure)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C0015131', 'cui_str': 'Etomidate'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0920253', 'cui_str': 'Postanesthetic Excitement'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia (procedure)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}]",35.0,0.0530917,The mean emergence agitation score in group B was significantly lower than that in group A when the maximum emergence in group B was at 20 min after entering into PACU (p < 0.05).,"[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Outpatient, Maternal and Child Health Hospital of Panzhihua, Panzhihua, Sichuan Province, China. Electronic address: huyanmc3h@163.com.'}, {'ForeName': 'X Y', 'Initials': 'XY', 'LastName': 'Yang', 'Affiliation': 'Department of Ophthalmology, The Affiliated Hospital of Panzhihua University, Panzhihua, Sichuan Province, China.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, The 19th Metallurgical Hospital of Panzhihua, Panzhihua, Sichuan Province, China.'}]",Medical hypotheses,['10.1016/j.mehy.2020.109666']
595,32226019,Bright light therapy for depressive symptoms in hospitalized cardiac patients: A randomized controlled pilot trial.,"Depression is common among cardiac patients and associated with adverse cardiovascular outcomes. Bright light therapy has emerged as a promising treatment for depressive symptoms, however it has not yet been investigated in this population. We conducted a double-blind, randomized, placebo-controlled pilot trial to assess the feasibility of a larger-scale trial testing bright light therapy for depressive symptoms in cardiac patients. Patients hospitalized for an acute coronary syndrome or undergoing cardiac surgery were randomized to either bright light (10,000 lux) or dim light placebo (500 lux) lamps for 30 minutes each day over 4 weeks, beginning in-hospital. Depression was quantified using the Patient Health Questionnaire 9 (PHQ-9) and Depression Anxiety and Stress Scales (DASS-21). The Short-Form Health Survey 36 (SF-36) was used to measure quality of life. A total of 175 patients were screened and 15 were randomized (8 treatment, 7 placebo) (8.6%) over 10 months. Despite protocol amendments which broadened the inclusion criteria, the trial was terminated early for infeasibility based on the rate of enrollment (1-2 participants/month), with 39.5% of the target sample (38 participants) enrolled. Future trials should take into account the timing of the onset of depressive symptoms in these patients, and consider a less conservative approach to eligibility as well as ways to increase the acceptability of bright light therapy in hospitalized cardiac patients. Once enrolled, our findings suggest that most participants will adhere to the assigned treatment and complete follow-up.",2020,"A total of 175 patients were screened and 15 were randomized (8 treatment, 7 placebo) (8.6%) over 10 months.","['Patients hospitalized for an acute coronary syndrome or undergoing cardiac surgery', 'hospitalized cardiac patients', 'A total of 175 patients were screened and 15 were randomized (8 treatment, 7', 'cardiac patients']","['bright light therapy', 'placebo', 'Bright light therapy', 'bright light (10,000 lux) or dim light placebo']","['depressive symptoms', 'Patient Health Questionnaire 9 (PHQ-9) and Depression Anxiety and Stress Scales (DASS-21', 'Depression', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0423899', 'cui_str': 'Gifted (observable entity)'}, {'cui': 'C0031765', 'cui_str': 'Photoradiation Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0560137', 'cui_str': 'lux (qualifier value)'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0222045'}, {'cui': 'C0034380'}]",175.0,0.586791,"A total of 175 patients were screened and 15 were randomized (8 treatment, 7 placebo) (8.6%) over 10 months.","[{'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Eisenberg', 'Affiliation': 'Center for Clinical Epidemiology, Jewish General Hospital, Lady Davis Institute, Montreal, QC, Canada.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Habib', 'Affiliation': 'Center for Clinical Epidemiology, Jewish General Hospital, Lady Davis Institute, Montreal, QC, Canada.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Alcaraz', 'Affiliation': 'Center for Clinical Epidemiology, Jewish General Hospital, Lady Davis Institute, Montreal, QC, Canada.'}, {'ForeName': 'Brett D', 'Initials': 'BD', 'LastName': 'Thombs', 'Affiliation': 'Center for Clinical Epidemiology, Jewish General Hospital, Lady Davis Institute, Montreal, QC, Canada.'}, {'ForeName': 'Kristian B', 'Initials': 'KB', 'LastName': 'Filion', 'Affiliation': 'Center for Clinical Epidemiology, Jewish General Hospital, Lady Davis Institute, Montreal, QC, Canada.'}]",PloS one,['10.1371/journal.pone.0230839']
596,32231364,"An Integrative Adapt Therapy for common mental health symptoms and adaptive stress amongst Rohingya, Chin, and Kachin refugees living in Malaysia: A randomized controlled trial.","BACKGROUND


This randomised controlled trial (RCT) aims to compare 6-week posttreatment outcomes of an Integrative Adapt Therapy (IAT) to a Cognitive Behavioural Therapy (CBT) on common mental health symptoms and adaptive capacity amongst refugees from Myanmar. IAT is grounded on psychotherapeutic elements specific to the refugee experience.
METHODS AND FINDINGS


We conducted a single-blind RCT (October 2017 -May 2019) with Chin (39.3%), Kachin (15.7%), and Rohingya (45%) refugees living in Kuala Lumpur, Malaysia. The trial included 170 participants receiving six 45-minute weekly sessions of IAT (97.6% retention, 4 lost to follow-up) and 161 receiving a multicomponent CBT also involving six 45-minute weekly sessions (96.8% retention, 5 lost to follow-up). Participants (mean age: 30.8 years, SD = 9.6) had experienced and/or witnessed an average 10.1 types (SD = 5.9, range = 1-27) of traumatic events. We applied a single-blind design in which independent assessors of pre- and posttreatment indices were masked in relation to participants' treatment allocation status. Primary outcomes were symptom scores of Post Traumatic Stress Disorder (PTSD), Complex PTSD (CPTSD), Major Depressive Disorder (MDD), the 5 scales of the Adaptive Stress Index (ASI), and a measure of resilience (the Connor-Davidson Resilience Scale [CDRS]). Compared to CBT, an intention-to-treat analysis (n = 331) at 6-week posttreatment follow-up demonstrated greater reductions in the IAT arm for all common mental disorder (CMD) symptoms and ASI domains except for ASI-3 (injustice), as well as increases in the resilience scores. Adjusted average treatment effects assessing the differences in posttreatment scores between IAT and CBT (with baseline scores as covariates) were -0.08 (95% CI: -0.14 to -0.02, p = 0.012) for PTSD, -0.07 (95% CI: -0.14 to -0.01) for CPTSD, -0.07 for MDD (95% CI: -0.13 to -0.01, p = 0.025), 0.16 for CDRS (95% CI: 0.06-0.026, p ≤ 0.001), -0.12 (95% CI: -0.20 to -0.03, p ≤ 0.001) for ASI-1 (safety/security), -0.10 for ASI-2 (traumatic losses; 95% CI: -0.18 to -0.02, p = 0.02), -0.03 for ASI-3 (injustice; (95% CI: -0.11 to 0.06, p = 0.513), -0.12 for ASI-4 (role/identity disruptions; 95% CI: -0.21 to -0.04, p ≤ 0.001), and -0.18 for ASI-5 (existential meaning; 95% CI: -0.19 to -0.05, p ≤ 0.001). Compared to CBT, the IAT group had larger effect sizes for all indices (except for resilience) including PTSD (IAT, d = 0.93 versus CBT, d = 0.87), CPTSD (d = 1.27 versus d = 1.02), MDD (d = 1.4 versus d = 1.11), ASI-1 (d = 1.1 versus d = 0.85), ASI-2 (d = 0.81 versus d = 0.66), ASI-3 (d = 0.49 versus d = 0.42), ASI-4 (d = 0.86 versus d = 0.67), and ASI-5 (d = 0.72 versus d = 0.53). No adverse events were recorded for either therapy. Limitations include a possible allegiance effect (the authors inadvertently conveying disproportionate enthusiasm for IAT in training and supervision), cross-over effects (counsellors applying elements of one therapy in delivering the other), and the brief period of follow-up.
CONCLUSIONS


Compared to CBT, IAT showed superiority in improving mental health symptoms and adaptative stress from baseline to 6-week posttreatment. The differences in scores between IAT and CBT were modest and future studies conducted by independent research teams need to confirm the findings.
TRIAL REGISTRATION


The study is registered under Australian New Zealand Clinical Trials Registry (ANZCTR) (http://www.anzctr.org.au/). The trial registration number is: ACTRN12617001452381.",2020,"Compared to CBT, the IAT group had larger effect sizes for all indices (except for resilience) including PTSD (IAT, d = 0.93 versus CBT, d = 0.87), CPTSD (","['170 participants receiving six 45-minute weekly sessions of IAT (97.6% retention, 4 lost to follow-up) and 161 receiving a', 'common mental health symptoms and adaptive stress amongst Rohingya, Chin, and Kachin refugees living in Malaysia', 'Participants (mean age: 30.8 years, SD = 9.6) had experienced and/or witnessed an average 10.1 types (SD = 5.9, range = 1-27) of traumatic events']","['Kachin', 'ASI-2', 'ASI-1', 'CBT, IAT', 'multicomponent CBT', 'Integrative Adapt Therapy (IAT', 'IAT', 'Cognitive Behavioural Therapy (CBT']","['ASI-2', 'ASI-1', 'mental health symptoms and adaptative stress', 'symptom scores of Post Traumatic Stress Disorder (PTSD), Complex PTSD (CPTSD), Major Depressive Disorder (MDD), the 5 scales of the Adaptive Stress Index (ASI), and a measure of resilience (the Connor-Davidson Resilience Scale [CDRS', 'MDD', 'adverse events']","[{'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C1442463', 'cui_str': 'Forty-five minutes (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0008114', 'cui_str': 'Mentum'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}, {'cui': 'C0024552', 'cui_str': 'Federation of Malaya'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0222045'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",170.0,0.276795,"Compared to CBT, the IAT group had larger effect sizes for all indices (except for resilience) including PTSD (IAT, d = 0.93 versus CBT, d = 0.87), CPTSD (","[{'ForeName': 'Alvin Kuowei', 'Initials': 'AK', 'LastName': 'Tay', 'Affiliation': 'School of Psychiatry, Faculty of Medicine, University of New South Wales, Australia.'}, {'ForeName': 'Hau Khat', 'Initials': 'HK', 'LastName': 'Mung', 'Affiliation': 'School of Psychiatry, Faculty of Medicine, University of New South Wales, Australia.'}, {'ForeName': 'Mohammad Abdul Awal', 'Initials': 'MAA', 'LastName': 'Miah', 'Affiliation': 'Perdana University-Centre for Research Excellence (PU-CRE), Selangor, Malaysia.'}, {'ForeName': 'Susheela', 'Initials': 'S', 'LastName': 'Balasundaram', 'Affiliation': 'Health Unit, United Nations High Commissioner for Refugees (UNHCR), Kuala Lumpur, Malaysia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ventevogel', 'Affiliation': 'Public Health Section/ Division of Programme Support & Management, United Nations High Commissioner for Refugees (UNHCR), Geneva, Switzerland.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Badrudduza', 'Affiliation': 'School of Psychiatry, Faculty of Medicine, University of New South Wales, Australia.'}, {'ForeName': 'Sanjida', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'Department of Psychology, Jagannath University, Dhaka, Bangladesh.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Morgan', 'Affiliation': 'Perdana University-Royal College of Surgeons in Ireland (PU-RCSI) School of Medicine, Selangor, Malaysia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Rees', 'Affiliation': 'School of Psychiatry, Faculty of Medicine, University of New South Wales, Australia.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Mohsin', 'Affiliation': 'School of Psychiatry, Faculty of Medicine, University of New South Wales, Australia.'}, {'ForeName': 'Derrick', 'Initials': 'D', 'LastName': 'Silove', 'Affiliation': 'School of Psychiatry, Faculty of Medicine, University of New South Wales, Australia.'}]",PLoS medicine,['10.1371/journal.pmed.1003073']
597,31083000,Propofol intravenous anaesthesia with desflurane compared with desflurane alone on postoperative liver function after living-donor liver transplantation: A randomised controlled trial.,"BACKGROUND


Propofol is an anaesthetic that resembles α-tocopherol and it has been suggested that it protects against ischaemia-reperfusion injury in liver transplantation. Living-donor liver transplantation (LDLT) presents an opportunity to test this hypothesis in both donors and recipients.
OBJECTIVES


We compared clinical outcomes after LDLT following anaesthesia with propofol and desflurane against desflurane alone.
DESIGN


A randomised, parallel study.
SETTING


Single-centre trial, study period June 2014 and May 2017.
PATIENTS


Sixty-two pairs of adult donors and recipients who underwent LDLT.
INTERVENTION


Patients were randomised to receive either desflurane balanced anaesthesia or propofol total intravenous anaesthesia combined with desflurane anaesthesia.
MAIN OUTCOME MEASURES


The primary outcome was peak liver transaminase levels during the first 7 days after surgery. Liver function was assessed at 10 different time-points (before surgery, 1 h after reperfusion, upon arrival in the ICU, and daily until postoperative day 7). Creatinine was measured to evaluate the incidence of acute kidney injury. TNF-α, IL-1β, IL-6 and TGF-β1 were assessed in 31 donors after induction, at hepatectomy and at the end of surgery and in 52 recipients after induction, and 1, 3 and 24 h after reperfusion.
RESULTS


Peak liver transaminase levels were not significantly different between the two groups. Liver function tests and creatinine were also similar between groups at all time-points. There was no difference in the incidence of postoperative complications, including acute kidney injury. With the exception of higher TNF-α in donors of the Propofol group at hepatectomy (0.60 ± 0.29 vs. 1.03 ± 0.53, P = 0.01) cytokine results were comparable between the two groups.
CONCLUSION


Despite the simultaneous administration of propofol infusion in both donors and recipients, no improvement in laboratory or surgical outcome was observed after LDLT compared with patients who received desflurane anaesthesia alone.
TRIAL REGISTRATION


NCT02504138 at clinicaltrials.gov.",2019,"RESULTS


Peak liver transaminase levels were not significantly different between the two groups.","['Sixty-two pairs of adult donors and recipients who underwent LDLT', 'after living-donor liver transplantation', 'Single-centre trial, study period June 2014 and May 2017']","['desflurane alone', 'LDLT', 'Propofol intravenous anaesthesia with desflurane', 'Living-donor liver transplantation (LDLT', 'desflurane anaesthesia', 'propofol', 'propofol and desflurane', 'Propofol', 'desflurane balanced anaesthesia or propofol total intravenous anaesthesia combined with desflurane anaesthesia']","['Creatinine', 'acute kidney injury', 'Liver function tests and creatinine', 'Peak liver transaminase levels', 'postoperative liver function', 'laboratory or surgical outcome', 'TNF-α, IL-1β, IL-6 and TGF-β1', 'Liver function', 'incidence of postoperative complications', 'peak liver transaminase levels']","[{'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0348050', 'cui_str': 'Living Donors'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002920', 'cui_str': 'Anesthesia, Intravenous'}, {'cui': 'C0348050', 'cui_str': 'Living Donors'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia (procedure)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0023901', 'cui_str': 'Liver Function Tests'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]",,0.147884,"RESULTS


Peak liver transaminase levels were not significantly different between the two groups.","[{'ForeName': 'Seokyung', 'Initials': 'S', 'LastName': 'Shin', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Severance Hospital (SS, MIB, EH, YCY), Anesthesia and Pain Research Institute, Yonsei University College of Medicine (SS, MIB, EH, J-SL, YCY), Department of Surgery, Yonsei University College of Medicine (DJJ, MSK), Department of Anesthesiology and Pain Medicine, Gangnam Severance Hospital, Seoul (J-SL) and Department of Policy Research Affairs, National Health Insurance Service Ilsan Hospital, Goyang-si, Gyeonggi-do, South Korea (DWK).'}, {'ForeName': 'Dong J', 'Initials': 'DJ', 'LastName': 'Joo', 'Affiliation': ''}, {'ForeName': 'Myoung S', 'Initials': 'MS', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Myung I', 'Initials': 'MI', 'LastName': 'Bae', 'Affiliation': ''}, {'ForeName': 'Eunjin', 'Initials': 'E', 'LastName': 'Heo', 'Affiliation': ''}, {'ForeName': 'Jong-Seok', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Dong W', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Young C', 'Initials': 'YC', 'LastName': 'Yoo', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001018']
598,31306184,Comparison of low and high positive end-expiratory pressure during low tidal volume ventilation in robotic gynaecological surgical patients using electrical impedance tomography: A randomised controlled trial.,"BACKGROUND


The appropriate level of positive end-expiratory pressure (PEEP) during intra-operative mechanical ventilation remains unclear.
OBJECTIVE


The aim of this study was to investigate the effects of different levels of PEEP with low tidal volume (low-VT) ventilation in a steep Trendelenburg position (30°) and pneumoperitoneum on oxygenation, respiratory mechanics and ventilation distribution using electrical impedance tomography.
DESIGN


A randomised controlled trial.
SETTING


Single university secondary care centre, conducted from January 2017 to December 2017.
PATIENTS


Forty female patients, aged 20 to 60 years, and of American Society of Anesthesiologists' (ASA) physical status 1 or 2, undergoing elective robotic gynaecological surgery were included.
INTERVENTION


Forty patients were allocated randomly to a PEEP4 (PEEP 4 cmH2O) group or a PEEP8 (PEEP 8 cmH2O) group.
MAIN OUTCOME MEASURES


The primary outcomes were respiratory mechanics. The secondary outcomes included changes in ventilation distribution across the ventral and dorsal regions of interest and postoperative pulmonary complications (PPCs) using a modified clinical pulmonary infection score.
RESULTS


There was no difference in PaO2 at any time point. The peak inspiratory pressure (PIP) and mean airway pressure (MPAW) of the PEEP4 group were lower than those of the PEEP8 group (P < 0.001). The oxygenation factor in the PEEP4 group was higher than that in the PEEP8 group during mechanical ventilation at all times. There was no difference in the fractional distribution of end-expiratory ventilation according to region of interest between the two groups.
CONCLUSION


Both 4 and 8 cmH2O of PEEP with low-VT ventilation can be used for robotic gynaecological surgery that requires a steep Trendelenburg position and pneumoperitoneum. However, 8 cmH2O of PEEP had no benefit over 4 cmH2O of PEEP with respect to oxygenation and improvement of dorsal regional ventilation.
TRIAL REGISTRATION


The trial was registered at the Clinical Trial Registry of Korea (KCT0002255). https://cris.nih.go.kr.",2019,The oxygenation factor in the PEEP4 group was higher than that in the PEEP8 group during mechanical ventilation at all times.,"[""Forty female patients, aged 20 to 60 years, and of American Society of Anesthesiologists' (ASA) physical status 1 or 2, undergoing elective robotic gynaecological surgery were included"", 'Single university secondary care centre, conducted from January 2017 to December 2017', 'robotic gynaecological surgical patients using electrical impedance tomography', 'Forty patients']","['PEEP with low tidal volume (low-VT) ventilation', 'low and high positive end-expiratory pressure during low tidal volume ventilation', 'PEEP with low-VT ventilation', 'PEEP4 (PEEP 4\u200acmH2O) group or a PEEP8 (PEEP 8\u200acmH2O) group', 'PEEP8']","['respiratory mechanics', 'peak inspiratory pressure (PIP) and mean airway pressure (MPAW', 'fractional distribution of end-expiratory ventilation', 'oxygenation factor', 'PaO2', 'dorsal regional ventilation', 'changes in ventilation distribution across the ventral and dorsal regions of interest and postoperative pulmonary complications (PPCs) using a modified clinical pulmonary infection score']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0162537', 'cui_str': 'Electrical Impedance'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0863179', 'cui_str': 'Peeping'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0040210', 'cui_str': 'Tidal Volume'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3494516', 'cui_str': 'Positive end expiratory pressure (observable entity)'}, {'cui': 'C0439476', 'cui_str': 'cmH2O'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0232021', 'cui_str': 'Maximum inspiratory pressure (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0442700', 'cui_str': 'End-expiration'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C1822073', 'cui_str': 'PaO2'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C1456859', 'cui_str': 'Thoracic region (surface region of back)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0876973', 'cui_str': 'Pulmonary infection'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",40.0,0.164233,The oxygenation factor in the PEEP4 group was higher than that in the PEEP8 group during mechanical ventilation at all times.,"[{'ForeName': 'Eun Hee', 'Initials': 'EH', 'LastName': 'Chun', 'Affiliation': 'From the Department of Anaesthesiology and Pain Medicine, College of Medicine, Ewha Womans University (HJB), Department of Anaesthesiology and Pain Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine (EHC), and Department of Obstetrics and Gynecology, College of Medicine, Ewha Womans University, Seoul, Republic of Korea (HM, KJ).'}, {'ForeName': 'Hee Jung', 'Initials': 'HJ', 'LastName': 'Baik', 'Affiliation': ''}, {'ForeName': 'Hye-Sung', 'Initials': 'HS', 'LastName': 'Moon', 'Affiliation': ''}, {'ForeName': 'Kyungah', 'Initials': 'K', 'LastName': 'Jeong', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001047']
599,31313720,Comparison of a simplified nasal continuous positive airways pressure device with nasal cannula in obese patients undergoing colonoscopy during deep sedation: A randomised clinical trial.,"BACKGROUND


Continuous positive airways pressure (CPAP) with a CPAP machine and mask has been shown to be more effective at minimising hypoxaemia than other devices under deep sedation. However, the efficacy of a new and simple CPAP device for spontaneously breathing obese patients during colonoscopy is unknown.
OBJECTIVE


We hypothesised that oxygenation and ventilation in obese patients under deep sedation during colonoscopy using CPAP via a new nasal mask (SuperNO2VA) would be better than routine care with oxygen supplementation via a nasal cannula.
DESIGN


Randomised study.
SETTING


Single-centre, June 2017 to October 2017.
PATIENTS


A total of 174 patients were enrolled and randomly assigned to Mask group or Control group. Thirty-eight patients were excluded and data from 136 patients underwent final analysis.
INTERVENTION


Patients in the Mask group were provided with nasal CPAP (10 cmH2O) at an oxygen flow rate of 15 l min. In the Control group, patients were given oxygen via a nasal cannula at a flow rate of 5 l min.
MAIN OUTCOME MEASURES


The primary outcome was elapsed time from anaesthesia induction to the first airway intervention.
RESULTS


The elapsed time from anaesthesia induction to the first airway intervention was 19 ± 10 min in the Mask group (n=63) vs. 10 ± 12 min in the Control group (n=73, P < 0.001). In all, 87.5% (56/64) of patients achieved the target CPAP value. More patients in the Control group (63%) received airway intervention than in the Mask group (22%) (P < 0.001). Hypoxaemia (pulse oximeter oxygen saturation, SpO2 < 90%) occurred more frequently in the Control group (22%) than in the Mask group (5%) (P = 0.004). Minute ventilationPostinduction/minute ventilationBaseline and minute ventilationProcedure-end/minute ventilationBaseline was lower in the Control group than in the Mask group (P = 0.007 and 0.001, respectively).
CONCLUSION


Application of a nasal mask at a target CPAP of 10 cmH2O improves ventilation and decreases the frequency and severity of hypoxaemia.
TRIAL REGISTRATION


NCT03139448, registered at ClinicalTrials.gov.",2019,"Hypoxaemia (pulse oximeter oxygen saturation, SpO2 < 90%) occurred more frequently in the Control group (22%) than in the Mask group (5%) (P = 0.004).","['obese patients under deep sedation during colonoscopy using CPAP via a new nasal mask (SuperNO2VA', 'A total of 174 patients', 'obese patients undergoing colonoscopy during deep sedation', 'Thirty-eight patients were excluded and data from 136 patients underwent final analysis', 'spontaneously breathing obese patients', 'Single-centre, June 2017 to October 2017']","['simplified nasal continuous positive airways pressure device with nasal cannula', 'new and simple CPAP device', 'CPAP machine and mask', 'airway intervention', 'nasal CPAP', 'Mask group or Control group']","['frequency and severity of hypoxaemia', 'Hypoxaemia (pulse oximeter oxygen saturation, SpO2\u200a<\u200a90', 'Minute ventilationPostinduction/minute ventilationBaseline and minute ventilationProcedure-end/minute ventilationBaseline', 'target CPAP value', 'elapsed time from anaesthesia induction to the first airway intervention']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956064', 'cui_str': 'Deep Sedation'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C2711254', 'cui_str': 'Dental mask'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C3665969', 'cui_str': 'Nasal CPAP'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0182109', 'cui_str': 'Pulse oximeter (physical object)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0439087', 'cui_str': '<90 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia (procedure)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}]",174.0,0.161291,"Hypoxaemia (pulse oximeter oxygen saturation, SpO2 < 90%) occurred more frequently in the Control group (22%) than in the Mask group (5%) (P = 0.004).","[{'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': ''}, {'ForeName': 'Zeping', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Chandrashekar', 'Affiliation': ''}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'St Jacques', 'Affiliation': ''}, {'ForeName': 'Yafen', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': ''}, {'ForeName': 'Yandong', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': ''}, {'ForeName': 'Koffi', 'Initials': 'K', 'LastName': 'Kla', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001052']
600,32090404,Cardiovascular and renal benefits of dapagliflozin in patients with short and long-standing type 2 diabetes: Analysis from the DECLARE-TIMI 58 trial.,"AIM


To investigate whether the cardiovascular and renal benefits observed with dapagliflozin in the DECLARE-TIMI 58 trial are also observed in patients with short and long-standing diabetes.
MATERIALS AND METHODS


This post hoc analysis studied the dual primary efficacy endpoints, a composite of cardiovascular death or hospitalization for heart failure (CVD/HHF) and major adverse cardiovascular events (MACE; CVD, myocardial infarction [MI], ischaemic stroke) by diabetes duration.
RESULTS


Of the 17 160 patients, 3836 had diabetes duration of ≤5 years, 4731 >5-10 years, 3952 >10-15 years, 2433 >15-20 years and 2206 >20 years. Dapagliflozin reduced the risk of CVD/HHF by a similar amount across diabetes duration subgroups, ranging from HR 0.79 (0.58-1.06) in patients with diabetes duration of ≤5 years to 0.75 (0.55-1.03) in those patients with diabetes duration of >20 years (interaction trend P-value 0.76). Hazard ratios (HRs) for MACE ranged from 1.08 (0.87-1.35) in patients with diabetes duration of ≤5 years to 0.67 (0.52-0.86) in those patients with diabetes duration of >20 years (interaction trend P-value 0.004). This was driven by greater reductions in the risk of MI and ischaemic stroke with dapagliflozin in patients with long-standing diabetes (interaction trend P-values 0.019 and 0.015, respectively). The duration-based MACE heterogeneity was apparent in those with or without a history of prior MI and in those with multiple risk factors. The renal-specific outcome was reduced with dapagliflozin with HRs ranging from 0.79 (0.47-1.34) in patients with diabetes duration of ≤5 years to 0.42 (0.25-0.72) in those patients with diabetes duration of >20 years (interaction trend P-value 0.084).
CONCLUSIONS


Dapagliflozin reduced the risk of CVD/HHF consistently, regardless of diabetes duration, whereas the treatment effect for MACE differed by duration subgroups, with significant reductions with dapagliflozin in patients with long-standing diabetes.",2020,"Dapagliflozin reduced the risk of CVD/HHF by a similar amount across diabetes duration subgroups, ranging from HR 0.79(0.58-1.06) in patients with duration ≤5 years to 0.75(0.55-1.03) in those >20 years (interaction-trend-p-value 0.76).","['Of the 17 160 patients, 3836 had diabetes duration ≤5 years, 4731 > 5-10 years, 3952 > 10-15 years, 2433 > 15-20 years, and 2206 > 20 years', 'patients with short- and long-standing diabetes', 'patients with longer-standing diabetes', 'patients with short and long-standing type 2 diabetes']","['dapagliflozin', 'Dapagliflozin']","['risk of MI and ischemic stroke', 'risk of CVD/HHF', 'Cardiovascular and renal benefits', 'renal-specific outcome', 'duration-based MACE heterogeneity', 'composite of cardiovascular death or hospitalization for heart failure (CVD/HHF) and major adverse cardiovascular events (MACE; CVD, myocardial infarction [MI], ischemic stroke), by diabetes duration']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]",17160.0,0.0290978,"Dapagliflozin reduced the risk of CVD/HHF by a similar amount across diabetes duration subgroups, ranging from HR 0.79(0.58-1.06) in patients with duration ≤5 years to 0.75(0.55-1.03) in those >20 years (interaction-trend-p-value 0.76).","[{'ForeName': 'Harpreet S', 'Initials': 'HS', 'LastName': 'Bajaj', 'Affiliation': 'LMC Diabetes and Endocrinology, Brampton, Ontario, Canada.'}, {'ForeName': 'Itamar', 'Initials': 'I', 'LastName': 'Raz', 'Affiliation': 'Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, The Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, The Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Aliza', 'Initials': 'A', 'LastName': 'Rozenberg', 'Affiliation': 'Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, The Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Yanuv', 'Affiliation': 'Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, The Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'Division of Cardiology, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'John P H', 'Initials': 'JPH', 'LastName': 'Wilding', 'Affiliation': 'Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Ingrid A M', 'Initials': 'IAM', 'LastName': 'Gause-Nilsson', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Avivit', 'Initials': 'A', 'LastName': 'Cahn', 'Affiliation': 'Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, The Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14011']
601,31727391,Effectiveness of a nurse-led multidisciplinary self-management program for patients with coronary heart disease in communities: A randomized controlled trial.,"OBJECTIVE


To examine the effectiveness of a nurse-led multidisciplinary self-management program (NMSP) on self-management behaviors, self-efficacy, health-related quality of life (HRQoL) and unplanned health service utilization (HSU) among Chinese patients with coronary heart disease (CHD) in communities.
METHODS


A randomized controlled trial with repeated measurements was used. A convenience sample of 144 participants was recruited from a community health center in China. All participants were randomly assigned to an intervention group (n = 72) in the newly developed NMSP or a control group (n = 72) in routine care. Outcome measurement was performed at baseline, 3 months and 6 months using Coronary Artery Disease Self-Management Scale (CADSs), Self-efficacy for Chronic Disease 6-item Scale (SECD6), and Short Form-12 health survey questionnaire (SF-12).
RESULTS


Over the six months, the two groups reported significant differences in disease medical and emotional management of CADSs, confidence in symptom and disease management of SECD6, physical and mental component summary of SF-12, as well as emergency and outpatient visits of unplanned HSU.
CONCLUSIONS


The NMSP improves self-management behaviors, self-efficacy, HRQoL and reduces unplanned HSU among CHD patients in communities.
PRACTICE IMPLICATIONS


This study provides an effective approach to empower CHD patients with emphasizing on collaboration support of health professionals in communities.",2020,"The NMSP improves self-management behaviors, self-efficacy, HRQoL and reduces unplanned HSU among CHD patients in communities.
","['Chinese patients with coronary heart disease (CHD) in communities', 'empower CHD patients with emphasizing on collaboration support of health professionals in communities', '144 participants was recruited from a community health center in China', 'CHD patients in communities', 'patients with coronary heart disease in communities']","['nurse-led multidisciplinary self-management program', 'NMSP', 'nurse-led multidisciplinary self-management program (NMSP', 'NMSP or a control group (n\u202f=\u202f72) in routine care']","['self-management behaviors, self-efficacy, HRQoL and reduces unplanned HSU', 'disease medical and emotional management of CADSs, confidence in symptom and disease management of SECD6, physical and mental component summary of SF-12, as well as emergency and outpatient visits of unplanned HSU', 'Coronary Artery Disease Self-Management Scale (CADSs), Self-efficacy for Chronic Disease 6-item Scale (SECD6), and Short Form-12 health survey questionnaire (SF-12', 'self-management behaviors, self-efficacy, health-related quality of life (HRQoL) and unplanned health service utilization (HSU']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376636', 'cui_str': 'Disease Management'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0222045'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0042153', 'cui_str': 'use'}]",144.0,0.0854298,"The NMSP improves self-management behaviors, self-efficacy, HRQoL and reduces unplanned HSU among CHD patients in communities.
","[{'ForeName': 'Wenhui', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': ""School of Nursing, Health Science Center, Xi'an Jiaotong University, Xi'an, 710061, China. Electronic address: jiangwenhui@mail.xjtu.edu.cn.""}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""School of Nursing, Health Science Center, Xi'an Jiaotong University, Xi'an, 710061, China.""}, {'ForeName': 'Fanghong', 'Initials': 'F', 'LastName': 'Yan', 'Affiliation': ""School of Nursing, Health Science Center, Xi'an Jiaotong University, Xi'an, 710061, China; School of Nursing, Lanzhou University, Lanzhou, 730000, China.""}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""School of Nursing, Health Science Center, Xi'an Jiaotong University, Xi'an, 710061, China.""}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Gao', 'Affiliation': ""School of Nursing, Health Science Center, Xi'an Jiaotong University, Xi'an, 710061, China.""}]",Patient education and counseling,['10.1016/j.pec.2019.11.001']
602,31733985,"Effect of inhaler drug education on fatigue, dyspnea severity, and respiratory function tests in patients with COPD.","OBJECTIVE


This study was conducted to examine the effect of inhaler drug education on fatigue, dyspnea severity, and respiratory function tests in patients with chronic obstructive pulmonary disease (COPD).
METHODS


This randomized controlled study was conducted with a total of 85 patients treated at the chest diseases clinic and outpatient clinic of a state hospital. The data were collected using questionnaires, respiratory function tests, and the COPD and Asthma Fatigue Scale (CAFS) and Visual Analogue Scale (VAS-for dyspnea severity).
RESULTS


It was determined that after 4 weeks of inhaler drug education, the CAFS mean score decreased to 35.32 ± 14.36, the dyspnea severity mean score decreased to 4.76 ± 2.50, and the respiratory function tests mean scores increased to forced expiratory volume in 1 s (FEV 1 ) = 58.83 ± 25.48, forced vital capacity (FVC) = 59.04 ± 19.19, and FEV 1 /FVC = 88.39 ± 21.59 in the intervention group (p < 0.05). No change was observed in the patients in the control group except for FEV 1  and FVC mean scores (p > 0.05).
CONCLUSION


These results demonstrate that inhaler drug education can improve fatigue, dyspnea severity, and respiratory function tests of patients with COPD.
PRACTICE IMPLICATIONS


The training by nurses of every patient hospitalized in the clinic regarding inhaler drug therapy, and the regular checking of patients' way of using the inhaled drugs, will contribute to COPD management.",2020,"No change was observed in the patients in the control group except for FEV 1  and FVC mean scores (p > 0.05).
","['85 patients treated at the chest diseases clinic and outpatient clinic of a state hospital', 'patients with COPD', 'patients with chronic obstructive pulmonary disease (COPD']",['inhaler drug education'],"['FEV 1  and FVC mean scores', 'fatigue, dyspnea severity, and respiratory function tests', 'COPD and Asthma Fatigue Scale (CAFS) and Visual Analogue Scale (VAS-for dyspnea severity', 'dyspnea severity mean score', 'CAFS mean score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0020026', 'cui_str': 'Hospitals, State'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}]","[{'cui': 'C0021461', 'cui_str': 'Inhalators'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0035227', 'cui_str': 'Respiratory Function Tests'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0222045'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",85.0,0.0239814,"No change was observed in the patients in the control group except for FEV 1  and FVC mean scores (p > 0.05).
","[{'ForeName': 'Sema', 'Initials': 'S', 'LastName': 'Ozoglu Aytac', 'Affiliation': 'Gaziantep University, Şahinbey, Research and Application Hospital, Gaziantep, Turkey.'}, {'ForeName': 'Serap Parlar', 'Initials': 'SP', 'LastName': 'Kilic', 'Affiliation': 'İnonu University Faculty of Nursing, Department of Internal Medicine Nursing, Battalgazi/Malatya, 44000, Turkey. Electronic address: serap.parlar27@gmail.com.'}, {'ForeName': 'Nimet', 'Initials': 'N', 'LastName': 'Ovayolu', 'Affiliation': 'Gaziantep University Faculty of Health Sciences, Department of Internal Medicine Nursing, Gaziantep, Turkey.'}]",Patient education and counseling,['10.1016/j.pec.2019.11.003']
603,32147390,Autologous cell-based therapy for male and female pattern hair loss using dermal sheath cup cells: A randomized placebo-controlled double-blinded dose-finding clinical study.,"BACKGROUND


Few effective treatments are available for male pattern hair loss (MPHL) or, especially, for female pattern hair loss (FPHL). Recently, cell-based therapies using autologous or allogeneic cells have been used clinically.
OBJECTIVE


We examined the safety and efficacy of autologous cell-based therapy using dermal sheath cup (DSC) cells to treat MPHL and FPHL.
METHODS


DSCs dissected from occipital hair follicles were cultured to manufacture DSC cells. Participants with MPHL or FPHL received single injections of 7.5 × 10 6 , 1.5 × 10 6 , or 3.0 × 10 5  DSC cells or a placebo in 4 randomized separate regions on the scalp, and hair densities and diameters were measured for 3, 6, 9, and 12 months.
RESULTS


Fifty men and 15 women aged 33 to 64 years were injected with DSC cells. Total hair density and cumulative hair diameter at the 3.0 × 10 5  DSC cells injection site was significantly increased compared with the placebo after 6 and 9 months. Men and women showed similar improvements, and there were no serious adverse events.
LIMITATIONS


No lower cell numbers were tested, and the positive effect was temporary until 9 months.
CONCLUSION


The results suggest that cell therapy with autologous DSC cells may be useful as a new therapeutic method for treating MPHL and FPHL.",2020,Total hair density and cumulative hair diameter at the 3.0x105DSC cells injection site was significantly increased compared with the placebo after 6 and 9 months.,"['Fifty males and 15 females aged 33 to 64 were injected with DSC cells', 'male pattern hair loss (MPHL) and especially for female pattern hair loss (FPHL', 'Subjects with MPHL or', 'Male and Female Pattern Hair Loss using Dermal Sheath Cup Cells']","['autologous cell-based therapy using dermal sheath cup (DSC) cells', 'FPHL', 'placebo', 'Placebo', 'Autologous Cell-Based Therapy']","['Total hair density and cumulative hair diameter at the 3.0x105DSC cells injection site', 'safety and efficacy', 'cell numbers']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C2949743', 'cui_str': 'Cup - unit of product usage'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C2949743', 'cui_str': 'Cup - unit of product usage'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0221208', 'cui_str': 'Injection site (morphologic abnormality)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0007584', 'cui_str': 'Cell Number'}]",,0.401402,Total hair density and cumulative hair diameter at the 3.0x105DSC cells injection site was significantly increased compared with the placebo after 6 and 9 months.,"[{'ForeName': 'Ryoji', 'Initials': 'R', 'LastName': 'Tsuboi', 'Affiliation': 'Tokyo Medical University Hospital, Department of Dermatology, Tokyo, Japan. Electronic address: tsuboi@tokyo-med.ac.jp.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Niiyama', 'Affiliation': 'Toho University Ohashi Medical Center, Department of Dermatology, Tokyo, Japan.'}, {'ForeName': 'Ryokichi', 'Initials': 'R', 'LastName': 'Irisawa', 'Affiliation': 'Tokyo Medical University Hospital, Department of Dermatology, Tokyo, Japan.'}, {'ForeName': 'Kazutoshi', 'Initials': 'K', 'LastName': 'Harada', 'Affiliation': 'Tokyo Medical University Hospital, Department of Dermatology, Tokyo, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Nakazawa', 'Affiliation': 'Shiseido FS Innovation Center, Regenerative Medicine Research & Business Development Section, Yokohama, Japan.'}, {'ForeName': 'Jiro', 'Initials': 'J', 'LastName': 'Kishimoto', 'Affiliation': 'Shiseido FS Innovation Center, Regenerative Medicine Research & Business Development Section, Yokohama, Japan.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.02.033']
604,32214373,Precision nicotine metabolism-informed care for smoking cessation in Crohn's disease: A pilot study.,"INTRODUCTION


Smoking is a strong risk factor for disease severity in Crohn's disease (CD) and cessation improves outcomes. The nicotine metabolite ratio (NMR) predicts cessation success with pharmacotherapy: varenicline doubles cessation over nicotine replacement therapy (NRT) for ""normal"", but not ""slow"" metabolizers. Varenicline side effects are heightened in slow metabolizers. Methods using NMR to optimize cessation pharmacotherapy have not been evaluated in CD.
AIMS


We aim to determine the prevalence of smoking in a CD population and then assess these smokers' attitudes toward a personalized metabolism-informed care (MIC) approach to cessation.
METHODS


In this observational study, we surveyed 1098 patients visiting an inflammatory bowel disease center about their smoking history. We then evaluated a subgroup of individuals with CD (n = 32) who participated in a randomized controlled trial of smoking cessation using MIC versus usual care. For MIC, medication selection was informed by the NMR (normal ≥0.31 vs. slow <0.31). The primary outcomes were intervention satisfaction and match rates between NMR and medication choice.
RESULTS


The baseline prevalence of smoking in our CD population was 13%. Intervention participants reported high rates of satisfaction (85%) and chose a medication that matched their NMR result more often in the MIC group (100% vs. 64%, p = 0.01). Six of 16 (37.5%) patients prescribed varenicline discontinued due to side effects.
CONCLUSION


MIC produced high rates of satisfaction and matching between NMR and medication in CD patients, supporting patient acceptance and feasibility of precision smoking cessation in this population. To reduce smoking in CD, therapies such as MIC are needed to maximize efficacy and minimize side effects.",2020,"The nicotine metabolite ratio (NMR) predicts cessation success with pharmacotherapy: varenicline doubles cessation over nicotine replacement therapy (NRT) for ""normal"", but not ""slow"" metabolizers.","[""Crohn's disease"", '1098 patients visiting an inflammatory bowel disease center about their smoking history', 'subgroup of individuals with CD (n = 32) who participated in a randomized controlled trial of smoking cessation using MIC versus usual care']","['Varenicline', 'nicotine metabolite ratio (NMR', 'nicotine replacement therapy (NRT', 'varenicline', 'Precision nicotine metabolism-informed care']","['intervention satisfaction and match rates between NMR and medication choice', 'high rates of satisfaction']","[{'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0427978', 'cui_str': 'Minimum Inhibitory Concentration'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",1098.0,0.030592,"The nicotine metabolite ratio (NMR) predicts cessation success with pharmacotherapy: varenicline doubles cessation over nicotine replacement therapy (NRT) for ""normal"", but not ""slow"" metabolizers.","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Scoville', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Hilary A', 'Initials': 'HA', 'LastName': 'Tindle', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Quinn S', 'Initials': 'QS', 'LastName': 'Wells', 'Affiliation': 'Division of Cardiology, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Shannon C', 'Initials': 'SC', 'LastName': 'Peyton', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Gurwara', 'Affiliation': 'Division of Gastroenterology, Wake Forest School of Medicine, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Stephanie O', 'Initials': 'SO', 'LastName': 'Pointer', 'Affiliation': 'Division of Gastroenterology, The Ohio State University Wexner Medical Center, Columbus, Ohio, United States of America.'}, {'ForeName': 'Sara N', 'Initials': 'SN', 'LastName': 'Horst', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Schwartz', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Dawn W', 'Initials': 'DW', 'LastName': 'Adams', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Freiberg', 'Affiliation': 'Geriatric Research Education and Clinical Centers (GRECC), Veterans Affairs Tennessee Valley Healthcare System, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Gatskie', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'King', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Lesa R', 'Initials': 'LR', 'LastName': 'Abney', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Dawn B', 'Initials': 'DB', 'LastName': 'Beaulieu', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}]",PloS one,['10.1371/journal.pone.0230656']
605,32214382,Cervicovaginal microbiome and natural history of HPV in a longitudinal study.,"BACKGROUND


Human papillomavirus (HPV) infection is one of the most common sexually transmitted infections. However, only a small percentage of high-risk (HR) HPV infections progress to cervical precancer and cancer. In this study, we investigated the role of the cervicovaginal microbiome (CVM) in the natural history of HR-HPV.
METHODS


This study was nested within the placebo arm of the Costa Rica HPV Vaccine Trial that included women aged 18-25 years of age. Cervical samples from two visits of women with an incident HR-HPV infection (n = 273 women) were used to evaluate the prospective role of the CVM on the natural history of HR-HPV. We focus specifically on infection clearance, persistence, and progression to cervical intraepithelial neoplasia grade 2 and 3 (CIN2+). The CVM was characterized by amplification and sequencing the bacterial 16S V4 rRNA gene region and the fungal ITS1 region using an Illumina MiSeq platform. OTU clustering was performed using QIIME2. Functional groups were imputed using PICRUSt and statistical analyses were performed using R.
RESULTS


At Visit 1 (V1) abundance of Lactobacillus iners was associated with clearance of incident HR-HPV infections (Linear Discriminant Analysis (LDA)>4.0), whereas V1 Gardnerella was the dominant biomarker for HR-HPV progression (LDA>4.0). At visit 2 (V2), increased microbial Shannon diversity was significantly associated with progression to CIN2+ (p = 0.027). Multivariate mediation analysis revealed that the positive association of V1 Gardnerella with CIN2+ progression was due to the increased cervicovaginal diversity at V2 (p = 0.040). A full multivariate model of key components of the CVM showed significant protective effects via V1 genus Lactobacillus, OR = 0.41 (0.22-0.79), V1 fungal diversity, OR = 0.90 (0.82-1.00) and V1 functional Cell Motility pathway, OR = 0.75 (0.62-0.92), whereas V2 bacterial diversity, OR = 1.19 (1.03-1.38) was shown to be predictive of progression to CIN2+.
CONCLUSION


This study demonstrates that features of the cervicovaginal microbiome are associated with HR-HPV progression in a prospective longitudinal cohort. The analyses indicated that the association of Gardnerella and progression to CIN2+ may actually be mediated by subsequent elevation of microbial diversity. Identified features of the microbiome associated with HR-HPV progression may be targets for therapeutic manipulation to prevent CIN2+.
TRIAL REGISTRATION


ClinicalTrials.gov NCT00128661.",2020,"At visit 2 (V2), increased microbial Shannon diversity was significantly associated with progression to CIN2+ (p = 0.027).","['women aged 18-25 years of age', 'Cervical samples from two visits of women with an incident HR-HPV infection (n = 273 women']","['cervicovaginal microbiome (CVM', 'Costa Rica HPV Vaccine', 'placebo']","['infection clearance, persistence, and progression to cervical intraepithelial neoplasia grade 2 and 3 (CIN2', 'clearance of incident HR-HPV infections', 'HR-HPV progression', 'cervicovaginal diversity', 'microbial Shannon diversity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0343641', 'cui_str': 'HPV Infection'}]","[{'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0010182', 'cui_str': 'Costa Rica'}, {'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0546816', 'cui_str': 'Persistence (finding)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0349459', 'cui_str': 'Cervical intraepithelial neoplasia grade 2 (disorder)'}, {'cui': 'C0343641', 'cui_str': 'HPV Infection'}]",273.0,0.0620375,"At visit 2 (V2), increased microbial Shannon diversity was significantly associated with progression to CIN2+ (p = 0.027).","[{'ForeName': 'Mykhaylo', 'Initials': 'M', 'LastName': 'Usyk', 'Affiliation': 'Department of Pediatrics (Genetic Medicine), Albert Einstein College of Medicine, Bronx, New York, United States of America.'}, {'ForeName': 'Christine P', 'Initials': 'CP', 'LastName': 'Zolnik', 'Affiliation': 'Department of Pediatrics (Genetic Medicine), Albert Einstein College of Medicine, Bronx, New York, United States of America.'}, {'ForeName': 'Philip E', 'Initials': 'PE', 'LastName': 'Castle', 'Affiliation': 'Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, New York, United States of America.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Porras', 'Affiliation': 'Agencia Costarricense de Investigaciones Biomédicas (ACIB), formerly Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, San José, Costa Rica.'}, {'ForeName': 'Rolando', 'Initials': 'R', 'LastName': 'Herrero', 'Affiliation': 'Prevention and Implementation Group, International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Gradissimo', 'Affiliation': 'Department of Pediatrics (Genetic Medicine), Albert Einstein College of Medicine, Bronx, New York, United States of America.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Gonzalez', 'Affiliation': 'Agencia Costarricense de Investigaciones Biomédicas (ACIB), formerly Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, San José, Costa Rica.'}, {'ForeName': 'Mahboobeh', 'Initials': 'M', 'LastName': 'Safaeian', 'Affiliation': 'Roche Molecular Diagnostics, Pleasanton, California, United States of America.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Schiffman', 'Affiliation': 'Division of Cancer Epidemiology and Genetics (DCEG), National Cancer Institute, NIH, Bethesda, Maryland, United States of America.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Burk', 'Affiliation': 'Department of Pediatrics (Genetic Medicine), Albert Einstein College of Medicine, Bronx, New York, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PLoS pathogens,['10.1371/journal.ppat.1008376']
606,31157652,Effects of goal-directed crystalloid vs. colloid fluid therapy on microcirculation during free flap surgery: A randomised clinical trial.,"BACKGROUND


Macro, and microcirculatory effects of crystalloids and colloids are difficult to compare, because interventions to achieve haemodynamic stability seldom follow similar criteria.
OBJECTIVES


Our aim was to compare the effects of crystalloids and colloids on the microcirculation during free flap surgery when management was guided by detailed haemodynamic assessment.
DESIGN


A randomised, controlled clinical trial.
SETTINGS


The investigation was performed at the University of Szeged, Hungary.
PATIENTS


Patients undergoing maxillofacial tumour resection and free flap reconstruction were randomised into groups treated with either intra-operative crystalloid (Ringerfundin, n = 15) or colloid (6% hydroxyethyl starch, HES, n = 15) solutions.
INTERVENTIONS


Macrohaemodynamics were monitored by a noncalibrated device (PulsioFlex-PULSION). Central venous oxygen saturation, venous-to-arterial PCO2-gap, lactate levels and urine output were measured hourly. Maintenance fluid was Ringerfundin (1 ml kg h), and a multimodal, individualised, approach-based algorithm was applied to guide haemodynamic support. Hypovolaemia was treated with Ringerfundin or HES fluid boluses, respectively. The microcirculatory effects were assessed by laser-Doppler flowmetry (PeriFlux 5000 LDPM), with the probe placed on the flap and on a control area. Measurements were performed after the flap was prepared, then 1 and 12 h later.
MAIN OUTCOME MEASURES


The primary end-point was microcirculatory perfusion as determined by laser-Doppler flowmetry.
RESULTS


There was no difference between the groups regarding patient characteristics. Both groups remained haemodynamically stable throughout due to the use of approximately a 1.5 times higher total fluid volume in the Ringerfundin group than in the HES group: mean ± SD: 2581 ± 986 and 1803 ± 497) ml, respectively, (P = 0.011). There was no significant difference in the microcirculatory blood flow between the groups.
CONCLUSION


Our results showed that when fluid management was guided by detailed haemodynamic assessment, more crystalloid than colloid was needed to maintain haemodynamic stability, but there was no difference between the effects of crystalloids and colloids on the microcirculation.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03288051.",2019,Both groups remained haemodynamically stable throughout due to the use of approximately a 1.5 times higher total fluid volume in the Ringerfundin group than in the HES group: mean ± SD: 2581 ± 986 and 1803 ± 497),"['Patients undergoing maxillofacial tumour resection and free flap reconstruction', 'microcirculation during free flap surgery']","['Ringerfundin', 'intra-operative crystalloid (Ringerfundin, n\u200a=\u200a15) or colloid (6% hydroxyethyl starch, HES, n\u200a=\u200a15) solutions', 'goal-directed crystalloid vs. colloid fluid therapy', 'crystalloids and colloids']","['Central venous oxygen saturation, venous-to-arterial PCO2-gap, lactate levels and urine output', 'microcirculatory effects', 'microcirculatory perfusion as determined by laser-Doppler flowmetry', 'total fluid volume', 'microcirculatory blood flow']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0441031', 'cui_str': 'Microsurgical Free Flaps'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C2975881', 'cui_str': 'Ringerfundin'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0009361', 'cui_str': 'Colloids'}, {'cui': 'C0020352', 'cui_str': 'hydroxyethylstarch'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0016286', 'cui_str': 'Fluid Therapy'}]","[{'cui': 'C0444466', 'cui_str': 'Central venous (qualifier value)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0391839', 'cui_str': 'PCO2'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1287298', 'cui_str': 'UO - Urine output'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0162520', 'cui_str': 'Laser-Doppler Flowmetry'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}]",,0.165452,Both groups remained haemodynamically stable throughout due to the use of approximately a 1.5 times higher total fluid volume in the Ringerfundin group than in the HES group: mean ± SD: 2581 ± 986 and 1803 ± 497),"[{'ForeName': 'Ildikó', 'Initials': 'I', 'LastName': 'László', 'Affiliation': ''}, {'ForeName': 'Ágnes', 'Initials': 'Á', 'LastName': 'Janovszky', 'Affiliation': ''}, {'ForeName': 'András', 'Initials': 'A', 'LastName': 'Lovas', 'Affiliation': ''}, {'ForeName': 'Viktória', 'Initials': 'V', 'LastName': 'Vargán', 'Affiliation': ''}, {'ForeName': 'Nándor', 'Initials': 'N', 'LastName': 'Öveges', 'Affiliation': ''}, {'ForeName': 'Tamás', 'Initials': 'T', 'LastName': 'Tánczos', 'Affiliation': ''}, {'ForeName': 'András', 'Initials': 'A', 'LastName': 'Mikor', 'Affiliation': ''}, {'ForeName': 'Domonkos', 'Initials': 'D', 'LastName': 'Trásy', 'Affiliation': ''}, {'ForeName': 'Zoltán', 'Initials': 'Z', 'LastName': 'Lóderer', 'Affiliation': ''}, {'ForeName': 'József', 'Initials': 'J', 'LastName': 'Piffkó', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Szabó', 'Affiliation': ''}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Molnár', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001024']
607,32240016,Combined influence of inspiratory loading and locomotor subsystolic cuff inflation on cardiovascular responses during submaximal exercise.,"It is unknown if simultaneous stimulation of the respiratory and locomotor muscle afferents via inspiratory loading (IL) and locomotor subsystolic cuff inflation (CUFF) influences the cardiovascular responses during exercise. We hypothesized that combined IL and CUFF (IL + CUFF) will result in greater increases in blood pressure (MAP) and systemic vascular resistance (SVR) than IL and CUFF alone during exercise. Eight adults (6 males/2 females) were enrolled and performed four 10-min bouts of constant-load cycling eliciting 40% maximal oxygen uptake on a single day. For each exercise bout, the first 5 min consisted of spontaneous breathing. The second 5 min consisted of voluntary hyperventilation (i.e., breathing frequency of 40 breaths/min) with IL (30% maximum inspiratory pressure), CUFF (80 mmHg), IL + CUFF, or no intervention (CTL) in randomized order. During exercise, cardiac output and MAP were determined via open-circuit acetylene wash-in and manual sphygmomanometry, respectively, and SVR was calculated. Across CTL, IL, CUFF, and IL + CUFF, MAP was greater with each condition (CTL: 97 ± 14; IL: 106 ± 13; CUFF: 114 ± 14; IL + CUFF: 119 ± 15 mmHg, all  P  < 0.02). Furthermore, SVR was greater with IL + CUFF compared with IL, CUFF, and CTL (CTL: 6.6 ± 1.1; IL: 7.5 ± 1.4; CUFF: 7.5 ± 1.3; IL + CUFF: 8.2 ± 1.4 mmHg·L -1 ·min -1 , all  P  < 0.02). Cardiac output was not different across conditions (CTL: 15.2 ± 3.8; IL: 14.8 ± 3.7; CUFF: 15.6 ± 3.5; IL + CUFF: 14.7 ± 4.3 L/min, all  P  > 0.05). These data demonstrate that simultaneous stimulation of respiratory and locomotor muscle afferent feedback results in additive MAP and SVR responses than IL and CUFF alone during submaximal exercise. These findings have important clinical implications for populations with exaggerated locomotor and respiratory muscle reflex feedbacks. NEW & NOTEWORTHY  Reflexes arising from the respiratory and locomotor muscles influence cardiovascular regulation during exercise. However, it is unclear how the respiratory and locomotor muscle reflexes interact when simultaneously stimulated. Herein, we demonstrate that stimulation of the respiratory and locomotor muscle reflexes yielded additive cardiovascular responses during submaximal exercise.",2020,"Cardiac output was not different across conditions (CTL: 15.2±3.8; IL: 14.8±3.7; CUFF: 15.6±3.5; IL+CUFF: 14.7±4.3L/min) (all, p>0.05).",['Eight adults (6M/2W'],"['IL+CUFF', 'combined IL and CUFF (IL+CUFF', 'voluntary hyperventilation (i.e. breathing frequency of 40 breaths/min) with IL (30% maximum inspiratory pressure (PI MAX )), CUFF (80 mmHg), IL+CUFF or no intervention (CTL', 'constant-load cycling eliciting 40% maximal oxygen uptake', 'CTL (CTL', 'Inspiratory Loading and Locomotor Subsystolic Cuff Inflation']","['Cardiac output', 'additive MAP and SVR responses', 'blood pressure (MAP) and systemic vascular resistance (SVR', 'Cardiovascular Responses']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0020578', 'cui_str': 'Hyperventilation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0232021', 'cui_str': 'Peak inspiratory pressure'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039195', 'cui_str': 'Cytotoxic T lymphocyte'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0021398', 'cui_str': 'Economic Inflation'}]","[{'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0442796', 'cui_str': 'Additive'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}]",,0.0343089,"Cardiac output was not different across conditions (CTL: 15.2±3.8; IL: 14.8±3.7; CUFF: 15.6±3.5; IL+CUFF: 14.7±4.3L/min) (all, p>0.05).","[{'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Smith', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester Minnesota.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Bruhn', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester Minnesota.'}, {'ForeName': 'Jessica D', 'Initials': 'JD', 'LastName': 'Berg', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester Minnesota.'}, {'ForeName': 'Amran A', 'Initials': 'AA', 'LastName': 'Nur', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester Minnesota.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Villarraga', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester Minnesota.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Olson', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester Minnesota.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00781.2019']
608,32243660,Game therapy a new approach to treat women facing mixed urinary incontinence: A study protocol.,"AIMS


To describe a pelvic floor muscle training (PFMT) isolated and associated with game therapy (PFMT + GT) for women facing mixed urinary incontinence (MUI) during climacteric period.
METHODS


To standardize a randomized controlled clinical trial intervention, a protocol was created, in an attempt to decrease women's symptomatology generated by MUI, through pelvic floor and abdomino-loin-pelvic muscles strength, and endurance. This study protocol will be composed of 32 volunteers, divided into two groups of 16. They will perform PFMT isolated or PFMT + GT, twice a week during 8 weeks. Interventions will last 40 minutes and will be divided into warming (5 minutes), training (30 minutes), and 5 minutes will be composed of resting time between exercises (1 minute each). Isolated PFMT sessions will be performed through four modalities of exercises: diaphragmatic, bridge, abdominal (plank), and pelvic mobility. PFMT + GT training will be carried out by using Wii Fit Plus games, such as Lotus Focus, Penguin Slide, Basic Step, and Hula Hoop from Wii equipment. Assessments will occur before, after, and 1 month after interventions. Vaginal manometry, 1-hour Pad Test, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), and Patient Global Intervention (PGI) will be used to evaluate the sample.
CONCLUSIONS


It is expected greater increase on pelvic floor muscle (PFM) strength, endurance, vaginal pressure for PFMT + GG. Moreover, it is supposed that PFMT + GT volunteers present better treatment adherence due to games motivational inclusion.",2020,"It is expected greater increase on pelvic floor muscle (PFM) strength, endurance, vaginal pressure for PFMT + GG.","['32 volunteers, divided into two groups of 16', 'women facing mixed urinary incontinence', 'women facing mixed urinary incontinence (MUI) during climacteric period']","['Game therapy', 'Vaginal manometry, 1-hour Pad Test, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), and Patient Global Intervention (PGI', 'pelvic floor muscle training (PFMT) isolated and associated with game therapy (PFMT\u2009+\u2009GT', 'PFMT\u2009+\u2009GT training']","['pelvic floor muscle (PFM) strength, endurance, vaginal pressure for PFMT\u2009+\u2009GG']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0869256', 'cui_str': 'Mixed urinary incontinence'}, {'cui': 'C0008943', 'cui_str': 'Change of Life'}]","[{'cui': 'C0454421', 'cui_str': 'Games for therapy'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0024751', 'cui_str': 'Manometry'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2711460', 'cui_str': 'International consultation on incontinence questionnaire'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0523816', 'cui_str': 'Pepsinogen I measurement'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",32.0,0.0395415,"It is expected greater increase on pelvic floor muscle (PFM) strength, endurance, vaginal pressure for PFMT + GG.","[{'ForeName': 'Maria Clara Eugênia', 'Initials': 'MCE', 'LastName': 'Oliveira', 'Affiliation': 'Health Science Center, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Livia Oliveira', 'Initials': 'LO', 'LastName': 'Bezerra', 'Affiliation': 'Health Science Center, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Priscylla Hellouyse', 'Initials': 'PH', 'LastName': 'Melo Ângelo', 'Affiliation': 'Health Science Center, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Maiara Costa', 'Initials': 'MC', 'LastName': 'de Oliveira', 'Affiliation': 'Health Science Center, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Edson', 'Initials': 'E', 'LastName': 'Silva-Filho', 'Affiliation': 'Graduate\xa0Program in\xa0Rehabilitation Sciences, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Tatiana Souza', 'Initials': 'TS', 'LastName': 'Ribeiro', 'Affiliation': 'Health Science Center, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Pegado', 'Affiliation': 'Graduate\xa0Program in\xa0Rehabilitation Sciences, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Maria Thereza Albuquerque Barbosa Cabral', 'Initials': 'MTABC', 'LastName': 'Micussi', 'Affiliation': 'Health Science Center, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.'}]",Neurourology and urodynamics,['10.1002/nau.24350']
609,32141709,"Mesh inlay, mesh kit or native tissue repair for women having repeat anterior or posterior prolapse surgery: randomised controlled trial (PROSPECT).","OBJECTIVE


To compare standard (native tissue) repair with synthetic mesh inlays or mesh kits.
DESIGN


Randomised controlled trial.
SETTING


Thirty-three UK hospitals.
POPULATION


Women having surgery for recurrent prolapse.
METHODS


Women recruited using remote randomisation.
MAIN OUTCOME MEASURES


Prolapse symptoms, condition-specific quality-of-life and serious adverse effects.
RESULTS


A Mean Pelvic Organ Prolapse Symptom Score at 1 year was similar for each comparison (standard 6.6 versus mesh inlay 6.1, mean difference [MD] -0.41, 95% CI -2.92 to 2.11: standard 6.6 versus mesh kit 5.9, MD -1.21 , 95% CI -4.13 to 1.72) but the confidence intervals did not exclude a minimally important clinical difference. There was no evidence of difference in any other outcome measure at 1 or 2 years. Serious adverse events, excluding mesh exposure, were similar at 1 year (standard 7/55 [13%] versus mesh inlay 5/52 [10%], risk ratio [RR] 1.05 [0.66-1.68]: standard 3/25 [12%] versus mesh kit 3/46 [7%], RR 0.49 [0.11-2.16]). Cumulative mesh exposure rates over 2 years were 7/52 (13%) in the mesh inlay arm, of whom four women required surgical revision; and 4/46 in the mesh kit arm (9%), of whom two required surgical revision.
CONCLUSIONS


We did not find evidence of a difference in terms of prolapse symptoms from the use of mesh inlays or mesh kits in women undergoing repeat prolapse surgery. Although the sample size was too small to be conclusive, the results provide a substantive contribution to future meta-analysis.
TWEETABLE ABSTRACT


There is not enough evidence to support use of synthetic mesh inlay or mesh kits for repeat prolapse surgery.",2020,We did not find evidence of a difference in terms of prolapse symptoms from the use of mesh inlays or mesh kits in women undergoing repeat prolapse surgery.,"['Women having surgery for recurrent prolapse', 'women undergoing repeat prolapse surgery', 'Women recruited using remote randomisation', '33 UK hospitals', 'women having repeat anterior or posterior prolapse surgery']","['standard (native tissue) repair against synthetic mesh inlays or mesh kits', 'Mesh inlay, mesh kit or native tissue repair']","['Mean Pelvic Organ Prolapse Symptom Score', 'surgical revision', 'prolapse symptoms', 'Prolapse symptoms, condition specific quality-of-life and serious adverse effects', 'Cumulative mesh exposure rates']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0021513', 'cui_str': 'Dental Inlays'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0877015', 'cui_str': 'Urogenital Prolapse'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",4.0,0.336306,We did not find evidence of a difference in terms of prolapse symptoms from the use of mesh inlays or mesh kits in women undergoing repeat prolapse surgery.,"[{'ForeName': 'Cma', 'Initials': 'C', 'LastName': 'Glazener', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Breeman', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Elders', 'Affiliation': 'NMAHP Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hemming', 'Affiliation': 'Department of Obstetrics and Gynaecology, Aberdeen Royal Infirmary, Aberdeen, UK.'}, {'ForeName': 'K G', 'Initials': 'KG', 'LastName': 'Cooper', 'Affiliation': 'Department of Obstetrics and Gynaecology, Aberdeen Royal Infirmary, Aberdeen, UK.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Freeman', 'Affiliation': 'Department of Obstetrics and Gynaecology, Plymouth Hospitals NHS Trust, Plymouth, UK.'}, {'ForeName': 'Arb', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': ""St Mary's Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hagen', 'Affiliation': 'NMAHP Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Montgomery', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kilonzo', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Boyers', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'McDonald', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'McPherson', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'MacLennan', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Usher Institute of Population Health Sciences & Informatics, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'F M', 'Initials': 'FM', 'LastName': 'Reid', 'Affiliation': ""St Mary's Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16197']
610,32007694,Zinc supplementation improves glucose homeostasis in patients with β-thalassemia major complicated with diabetes mellitus: A randomized controlled trial.,"OBJECTIVES


The development of abnormal glucose tolerance in β-thalassemia major (β-TM) is associated with alterations in the oxidant-antioxidant status. Zinc is an antioxidant and an essential element for insulin synthesis, storage, and secretion. This randomized controlled trial assessed the effect of oral zinc supplementation on glucose homeostasis in pediatric β-TM patients complicated with diabetes mellitus (DM).
METHODS


Eighty patients were randomly assigned into two groups: an intervention group that received oral zinc in a dose of 40 mg/d for 12 wk and a placebo group. Hemolysis markers, serum ferritin, fasting blood glucose (FBG), fructosamine, fasting C-peptide, urinary albumin excretion (UAE), and serum zinc levels were assessed. Homeostasis model assessment insulin resistance index (HOMA-IR) was calculated.
RESULTS


Baseline clinical and laboratory parameters were consistent among both groups. Baseline zinc levels were decreased in both groups compared with control values. After 12 wk, supplementation with zinc for the intervention group resulted in a significant decrease in lactate dehydrogenase, serum ferritin, FBG, fructosamine, HOMA-IR, and UAE, whereas fasting C-peptide was higher compared with baseline levels and with the placebo group (P < 0.05). Baseline serum zinc was negatively correlated to FBG (r = -0.534, P < 0.001) and fructosamine (r = -0.555, P < 0.001) but positively correlated to fasting C-peptide (r = 0.777, P = 0.002).
CONCLUSIONS


Zinc supplementation as an adjuvant therapy in β-TM patients with DM reduced iron burden, decreased hyperglycemia, increased insulin secretion, and improved glycemic control without any adverse effects.",2020,"After 12 wk, supplementation with zinc for the intervention group resulted in a significant decrease in lactate dehydrogenase, serum ferritin, FBG, fructosamine, HOMA-IR, and UAE, whereas fasting C-peptide was higher compared with baseline levels and with the placebo group (P < 0.05).","['pediatric β-TM patients complicated with diabetes mellitus (DM', 'Eighty patients', 'patients with β-thalassemia major complicated with diabetes mellitus']","['placebo', 'oral zinc supplementation', 'oral zinc', 'Zinc supplementation']","['Baseline serum zinc', 'Baseline zinc levels', 'FBG (r', 'Homeostasis model assessment insulin resistance index (HOMA-IR', 'lactate dehydrogenase, serum ferritin, FBG, fructosamine, HOMA-IR, and UAE, whereas fasting C-peptide', 'Hemolysis markers, serum ferritin, fasting blood glucose (FBG), fructosamine, fasting C-peptide, urinary albumin excretion (UAE), and serum zinc levels', 'fasting C-peptide', 'iron burden, decreased hyperglycemia, increased insulin secretion', 'fructosamine', 'glucose homeostasis']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0002875', 'cui_str': 'Thalassemia Major'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}]","[{'cui': 'C0856205', 'cui_str': 'Serum zinc'}, {'cui': 'C0373748', 'cui_str': 'Zinc measurement (procedure)'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0022917', 'cui_str': 'L-Lactate Dehydrogenase'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0060765', 'cui_str': 'D-Isoglucosamine'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C2937287', 'cui_str': 'Hemolysis (observable entity)'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C1318315', 'cui_str': 'Serum zinc measurement'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}]",80.0,0.369322,"After 12 wk, supplementation with zinc for the intervention group resulted in a significant decrease in lactate dehydrogenase, serum ferritin, FBG, fructosamine, HOMA-IR, and UAE, whereas fasting C-peptide was higher compared with baseline levels and with the placebo group (P < 0.05).","[{'ForeName': 'Randa Mahmoud', 'Initials': 'RM', 'LastName': 'Matter', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Nancy Samir', 'Initials': 'NS', 'LastName': 'Elbarbary', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Ain Shams University, Cairo, Egypt. Electronic address: nancy_elbarbary@med.asu.edu.eg.'}, {'ForeName': 'Eman Abdel Rahman', 'Initials': 'EAR', 'LastName': 'Ismail', 'Affiliation': 'Department of Clinical Pathology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Yasser Wagih', 'Initials': 'YW', 'LastName': 'Darwish', 'Affiliation': 'Department of Clinical Pathology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Ahmed Shafik', 'Initials': 'AS', 'LastName': 'Nada', 'Affiliation': 'Drug Radiation Research Department, National Center for Radiation Research and Technology, Egyptian Atomic Energy Authority, Cairo, Egypt.'}, {'ForeName': 'Veronia Philip', 'Initials': 'VP', 'LastName': 'Banoub', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2019.110702']
611,30575628,Dopamine Optimizes Venous Return During Cardiopulmonary Bypass and Reduces the Need for Postoperative Blood Transfusion.,"Venodilation occurs shortly after the institution of cardiopulmonary bypass (CPB), necessitating fluid or vasoconstrictor administration to maintain adequate oxygen delivery. The vasoconstrictor effects of dopamine are not well studied in this context. Therefore, we conducted a single-center, double-blind case-control study to determine the role and utility of dopamine as a vasoconstrictor during CPB. The study included 60 adults who were scheduled for isolated elective/urgent coronary artery bypass grafting. Patients in group A (n = 30) received a dopamine bolus (2 mg) 20 min after cross-clamping, whereas patients in group B (n = 30) did not receive any intervention at a specific time point. Both groups received standard care as needed (fluid replacement or norepinephrine bolus). Venous return was measured directly in the reservoir and indirectly by Doppler measurement at the level of the inferior vena cava with transesophageal echocardiography. Both open and closed circuits were used for CPB. A single dopamine bolus (2 mg) increased volume in the venous reservoir in group A. Group A patients also received significantly fewer units of red blood cells in the intensive care unit (ICU) than did patients in group B. There were no significant between-group differences in postoperative bleeding, mechanical ventilation, or length of stay in the ICU. These findings suggest that use of a dopamine bolus can increase venous return and reduce the need for fluid replacement during and after CPB in patients undergoing coronary artery bypass grafting.",2019,"B. There were no significant between-group differences in postoperative bleeding, mechanical ventilation, or length of stay in the ICU.","['patients undergoing coronary artery bypass grafting', '60 adults who were scheduled for isolated elective/urgent coronary artery bypass grafting']","['dopamine bolus', 'Dopamine Optimizes Venous Return', 'standard care as needed (fluid replacement or norepinephrine bolus', 'dopamine']","['postoperative bleeding, mechanical ventilation, or length of stay in the ICU', 'Venodilation', 'red blood cells', 'Venous return']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}]","[{'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0521302', 'cui_str': 'Body fluid replacement (procedure)'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}]","[{'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}]",60.0,0.0390132,"B. There were no significant between-group differences in postoperative bleeding, mechanical ventilation, or length of stay in the ICU.","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Moscarelli', 'Affiliation': 'From the GVM Care & Research, Department of Cardiovascular Surgery, Anthea Hospital, Bari, Italy.'}, {'ForeName': 'Ignazio', 'Initials': 'I', 'LastName': 'Condello', 'Affiliation': 'From the GVM Care & Research, Department of Cardiovascular Surgery, Anthea Hospital, Bari, Italy.'}, {'ForeName': 'Khalil', 'Initials': 'K', 'LastName': 'Fattouch', 'Affiliation': 'GVM Care & Research, Department of Cardiovascular Surgery, Villa Maria Eleonora, Palermo, Italy.'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Punjabi', 'Affiliation': 'Hammersmith Hospital, Imperial College, London, United Kingdom.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Ajello', 'Affiliation': 'Department of Anesthesiology, Tor Vergata University, Rome, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Solimando', 'Affiliation': 'GVM Care & Research, Department of Anesthesia, Anthea Hospital, Bari, Italy.'}, {'ForeName': 'Flavio', 'Initials': 'F', 'LastName': 'Fiore', 'Affiliation': 'GVM Care & Research, Department of Anesthesia, Anthea Hospital, Bari, Italy.'}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Angelini', 'Affiliation': 'Bristol Royal Infirmary, Bristol, United Kingdom.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Speziale', 'Affiliation': 'From the GVM Care & Research, Department of Cardiovascular Surgery, Anthea Hospital, Bari, Italy.'}]",ASAIO journal (American Society for Artificial Internal Organs : 1992),['10.1097/MAT.0000000000000930']
612,32246728,Transition of Patients with Opioid Use Disorder from Buprenorphine to Extended-Release Naltrexone: A Randomized Clinical Trial Assessing Two Transition Regimens.,"BACKGROUND AND OBJECTIVE


When patients seek to discontinue buprenorphine (BUP) treatment, monthly injectable extended-release naltrexone (XR-NTX) may help them avoid relapse. The efficacy of low ascending doses of oral NTX vs placebo for patients transitioning from BUP to XR-NTX is evaluated in this study.
METHODS


In a phase 3, hybrid residential/outpatient study, clinically stable participants with opioid use disorder (N = 101), receiving BUP for more than or equal to 3 months and seeking antagonist treatment, were randomized (1:1) to 7 residential days of descending doses of BUP and low ascending doses of oral NTX (NTX/BUP, n = 50) or placebo (PBO-N/BUP, n = 51). Both groups received standing ancillary medications and psychoeducational counseling. Following negative naloxone challenge, participants received XR-NTX (day 8). The primary endpoint was the proportion of participants who received and tolerated XR-NTX.
RESULTS


There was no statistical difference between groups for participants receiving a first dose of XR-NTX: 68.6% (NTX/BUP) vs 76.0% (PBO-N/BUP; P = .407). The mean number of days with peak Clinical Opiate Withdrawal Scale (COWS) score less than or equal to 12 during the treatment period (days 1-7) was similar for NTX/BUP and PBO-N/BUP groups (5.8 vs 6.3; P = .511). Opioid withdrawal symptoms during XR-NTX induction and post-XR-NTX observation period (days 8-11) were mild and similar between groups (mean peak COWS score: NTX/BUP, 5.1 vs PBO-N/BUP, 5.4; P = .464). Adverse events were mostly mild/moderate.
CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE


Low ascending doses of oral NTX did not increase induction rates onto XR-NTX compared with placebo. The overall rate of successful induction across treatment groups supports a brief BUP taper with standing ancillary medications as a well-tolerated approach for patients seeking transition from BUP to XR-NTX. (Am J Addict 2020;00:00-00).",2020,There was no statistical difference between groups for participants receiving a first dose of XR-NTX: 68.6% (NTX/BUP) vs 76.0% (PBO-N/BUP; P = .407).,"['Patients with Opioid Use Disorder from', 'clinically stable participants with opioid use disorder (N\u2009=\u2009101), receiving BUP for more than or equal to 3 months and seeking antagonist treatment', 'patients transitioning from BUP to XR-NTX']","['naltrexone (XR-NTX', 'oral NTX', 'XR-NTX', 'Buprenorphine', 'discontinue buprenorphine (BUP', 'placebo', 'BUP and low ascending doses of oral NTX (NTX/BUP, n\u2009=\u200950) or placebo (PBO-N/BUP, n\u2009=\u200951', 'standing ancillary medications and psychoeducational counseling', 'Naltrexone', 'oral NTX vs placebo']","['overall rate of successful induction', 'proportion of participants who received and tolerated XR-NTX', 'Adverse events', 'mean number of days with peak Clinical Opiate Withdrawal Scale (COWS) score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4019079', 'cui_str': 'Care Transition'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C4706547', 'cui_str': 'Clinical Opiate Withdrawal Scale score'}]",,0.0223737,There was no statistical difference between groups for participants receiving a first dose of XR-NTX: 68.6% (NTX/BUP) vs 76.0% (PBO-N/BUP; P = .407).,"[{'ForeName': 'Sandra D', 'Initials': 'SD', 'LastName': 'Comer', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Mannelli', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Danesh', 'Initials': 'D', 'LastName': 'Alam', 'Affiliation': 'Northwestern Medicine Central DuPage Hospital, Winfield, Illinois.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Douaihy', 'Affiliation': 'Departments of Psychiatry and Medicine, Western Psychiatric Hospital, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Narinder', 'Initials': 'N', 'LastName': 'Nangia', 'Affiliation': 'Alkermes, Inc., Waltham, Massachusetts.'}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Akerman', 'Affiliation': 'Alkermes, Inc., Waltham, Massachusetts.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Zavod', 'Affiliation': 'Alkermes, Inc., Waltham, Massachusetts.'}, {'ForeName': 'Bernard L', 'Initials': 'BL', 'LastName': 'Silverman', 'Affiliation': 'Alkermes, Inc., Waltham, Massachusetts.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Sullivan', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, New York.'}]",The American journal on addictions,['10.1111/ajad.13024']
613,32087340,"The OaSiS trial: A hybrid type II, national cluster randomized trial to implement smoking cessation during CT screening for lung cancer.","INTRODUCTION


When the Centers for Medicare and Medicaid Services announced coverage for low dose CT lung cancer screening, they also mandated that imaging centers offer smoking cessation services. We designed the Optimizing Lung Screening (OaSiS) trial to evaluate strategies to implement the Public Health Service Guidelines for Treating Tobacco Use and Dependence during CT screening for lung cancer.
METHODS AND DESIGN


OaSiS was implemented using a pragmatic effectiveness-implementation hybrid design in 26 imaging clinics across the United States affiliated with the National Cancer Institute's National Community Oncology Research Program (NCORP). The 26 sites selected for participation in the OaSiS trial were randomized to receive either a compendium of implementation strategies to add or enhance smoking cessation services during lung screening or to usual care. Usual care sites were given the option to receive the full compendium of implementation strategies at the conclusion of data collection. We have evaluated both the effectiveness of the implementation strategies to improve smoking cessation at six months among patients undergoing LDCT screening as well as the adoption and sustainability of evidence-based tobacco cessation strategies in imaging clinics.
DISCUSSION


The OaSiS trial was designed to identify opportunities for implementing evidence-based smoking cessation into LDCT lung cancer screening imaging facilities and to establish the effectiveness of these services. We report our study design and evaluation, including strengths of the pragmatic design and the inclusion of a diverse range of screening programs. Establishing these tobacco cessation services will be critical to reducing smoking related morbidity and mortality.",2020,"We have evaluated both the effectiveness of the implementation strategies to improve smoking cessation at six months among patients undergoing LDCT screening as well as the adoption and sustainability of evidence-based tobacco cessation strategies in imaging clinics.
","['patients undergoing LDCT screening', ""26 imaging clinics across the United States affiliated with the National Cancer Institute's National Community Oncology Research Program (NCORP"", '26 sites selected for participation in the OaSiS trial', 'for lung cancer']","['compendium of implementation strategies to add or enhance smoking cessation services during lung screening or to usual care', 'smoking cessation during CT screening']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0035168'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0766345', 'cui_str': 'OASIS'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}]","[{'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]",[],26.0,0.0444411,"We have evaluated both the effectiveness of the implementation strategies to improve smoking cessation at six months among patients undergoing LDCT screening as well as the adoption and sustainability of evidence-based tobacco cessation strategies in imaging clinics.
","[{'ForeName': 'Kristie Long', 'Initials': 'KL', 'LastName': 'Foley', 'Affiliation': 'Wake Forest School of Medicine, Department of Implementation Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America. Electronic address: kfoley@wakehealth.edu.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Miller', 'Affiliation': 'Wake Forest School of Medicine, Department of Implementation Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America; Internal Medicine, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Weaver', 'Affiliation': 'Wake Forest School of Medicine, Department of Implementation Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America; Social Sciences and Health Policy, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Sutfin', 'Affiliation': 'Social Sciences and Health Policy, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'W Jeffrey', 'Initials': 'WJ', 'LastName': 'Petty', 'Affiliation': 'Hematology and Oncology, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Bellinger', 'Affiliation': 'Pulmonology and Critical Care, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Spangler', 'Affiliation': 'Family and Community Medicine, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Stone', 'Affiliation': 'Wake Forest School of Medicine, Department of Implementation Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Lawler', 'Affiliation': 'Wake Forest School of Medicine, Department of Implementation Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Davis', 'Affiliation': 'Wake Forest School of Medicine, Department of Implementation Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Dressler', 'Affiliation': 'Biostatistics and Data Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Lesser', 'Affiliation': 'Internal Medicine, Medical Center Blvd., Winston-Salem, NC 27157, United States of America; Hematology and Oncology, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Chiles', 'Affiliation': 'Radiology, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105963']
614,31116114,Effect of positive end-expiratory pressure on gastric insufflation during induction of anaesthesia when using pressure-controlled ventilation via a face mask: A randomised controlled trial.,"BACKGROUND


Face mask ventilation (FMV) during induction of anaesthesia is associated with risk of gastric insufflation that may lead to gastric regurgitation and pulmonary aspiration. A continuous positive airway pressure (CPAP) has been shown to reduce gastric regurgitation. We therefore hypothesised that CPAP followed by FMV with positive end-expiratory pressure (PEEP) during induction of anaesthesia would reduce the risk of gastric insufflation.
OBJECTIVE


The primary aim was to compare the incidence of gastric insufflation during FMV with a fixed PEEP level or zero PEEP (ZEEP) after anaesthesia induction. A secondary aim was to investigate the effects of FMV with or without PEEP on upper oesophageal sphincter (UES), oesophageal body and lower oesophageal sphincter (LES) pressures.
DESIGN


A randomised controlled trial.
SETTING


Single centre, Department of Anaesthesia and Intensive Care, Örebro University Hospital, Sweden.
PARTICIPANTS


Thirty healthy volunteers.
INTERVENTIONS


Pre-oxygenation without or with CPAP 10 cmH2O, followed by pressure-controlled FMV with either ZEEP or PEEP 10 cmH2O after anaesthesia induction.
MAIN OUTCOME MEASURES


A combined impedance/manometry catheter was used to detect the presence of gas and to measure oesophageal pressures. The primary outcome measure was the cumulative incidence of gastric insufflation, defined as a sudden anterograde increase in impedance of more than 1 kΩ over the LES. Secondary outcome measures were UES, oesophageal body and LES pressures.
RESULTS


The cumulative incidence of gastric insufflation related to peak inspiratory pressure (PIP), was significantly higher in the PEEP group compared with the ZEEP group (log-rank test P < 0.01). When PIP reached 30 cmH2O, 13 out of 15 in the PEEP group compared with five out of 15 had shown gastric insufflation. There was a significant reduction of oesophageal sphincter pressures within groups comparing pre-oxygenation to after anaesthesia induction, but there were no significant differences in oesophageal sphincter pressures related to the level of PEEP.
CONCLUSION


Contrary to the primary hypothesis, with increasing PIP the tested PEEP level did not protect against but facilitated gastric insufflation during FMV. This result suggests that PEEP should be used with caution after anaesthesia induction during FMV, whereas CPAP during pre-oxygenation seems to be safe.
TRIAL REGISTRATION


ClinicalTrials.gov, identifier: NCT02238691.",2019,"There was a significant reduction of oesophageal sphincter pressures within groups comparing pre-oxygenation to after anaesthesia induction, but there were no significant differences in oesophageal sphincter pressures related to the level of PEEP.
","['Thirty healthy volunteers', 'Single centre, Department of Anaesthesia and Intensive Care, Örebro University Hospital, Sweden']","['continuous positive airway pressure (CPAP', 'positive end-expiratory pressure', 'FMV with or without PEEP', 'ZEEP', 'Face mask ventilation (FMV', 'FMV with a fixed PEEP level or zero PEEP (ZEEP', 'CPAP', 'Pre-oxygenation without or with CPAP 10\u200acmH2O, followed by pressure-controlled FMV with either ZEEP or PEEP']","['UES, oesophageal body and LES pressures', 'cumulative incidence of gastric insufflation, defined as a sudden anterograde increase in impedance of more than 1\u200akΩ over the LES', 'upper oesophageal sphincter (UES), oesophageal body and lower oesophageal sphincter (LES) pressures', 'gastric insufflation', 'oesophageal sphincter pressures', 'cumulative incidence of gastric insufflation related to peak inspiratory pressure (PIP']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0085559'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C3494516', 'cui_str': 'Positive end expiratory pressure (observable entity)'}, {'cui': 'C0863179', 'cui_str': 'Peeping'}, {'cui': 'C0180823', 'cui_str': 'Face mask (physical object)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0439476', 'cui_str': 'cmH2O'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1276802', 'cui_str': 'Sudden onset'}, {'cui': 'C0589502', 'cui_str': 'Antegrade direction (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0162537', 'cui_str': 'Electrical Impedance'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0014865', 'cui_str': 'Esophageal sphincter (body structure)'}, {'cui': 'C0232530', 'cui_str': 'Lower esophageal sphincter pressure (observable entity)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0232021', 'cui_str': 'Maximum inspiratory pressure (observable entity)'}]",30.0,0.186467,"There was a significant reduction of oesophageal sphincter pressures within groups comparing pre-oxygenation to after anaesthesia induction, but there were no significant differences in oesophageal sphincter pressures related to the level of PEEP.
","[{'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Cajander', 'Affiliation': 'From the Department of Anaesthesia and Intensive Care, Faculty of Medicine and Health Örebro University, Örebro (PC), Department of Anaesthesia and Intensive Care, Västmanland Hospital, Västerås (LE), Department of Anaesthesia and Intensive Care, Faculty of Medicine and Health (RA), Clinical Epidemiology and Biostatistics, Faculty of Medicine and Health (AM), and Department of Anaesthesia and Intensive Care, Sahlgrenska University Hospital, Faculty of Medicine and Health, Örebro University, Örebro, Sweden (AdL).'}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Edmark', 'Affiliation': ''}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Ahlstrand', 'Affiliation': ''}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Magnuson', 'Affiliation': ''}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'de Leon', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001016']
615,32217739,Efficacy of Melatonin in Children With Postconcussive Symptoms: A Randomized Clinical Trial.,"BACKGROUND


Approximately 25% of children with concussion have persistent postconcussive symptoms (PPCS) with resultant significant impacts on quality of life. Melatonin has significant neuroprotective properties, and promising preclinical data suggest its potential to improve outcomes after traumatic brain injury. We hypothesized that treatment with melatonin would result in a greater decrease in PPCS symptoms when compared with a placebo.
METHODS


We conducted a randomized, double-blind trial of 3 or 10 mg of melatonin compared with a placebo (NCT01874847). We included youth (ages 8-18 years) with PPCS at 4 to 6 weeks after mild traumatic brain injury. Those with significant medical or psychiatric histories or a previous concussion within the last 3 months were excluded. The primary outcome was change in the total youth self-reported Post-Concussion Symptom Inventory score measured after 28 days of treatment. Secondary outcomes included change in health-related quality of life, cognition, and sleep.
RESULTS


Ninety-nine children (mean age: 13.8 years; SD = 2.6 years; 58% girls) were randomly assigned. Symptoms improved over time with a median Post-Concussion Symptom Inventory change score of -21 (95% confidence interval [CI]: -16 to -27). There was no significant effect of melatonin when compared with a placebo in the intention-to-treat analysis (3 mg melatonin, -2 [95% CI: -13 to 6]; 10 mg melatonin, 4 [95% CI: -7 to 14]). No significant group differences in secondary outcomes were observed. Side effects were mild and similar to the placebo.
CONCLUSIONS


Children with PPCS had significant impairment in their quality of life. Seventy-eight percent demonstrated significant recovery between 1 and 3 months postinjury. This clinical trial does not support the use of melatonin for the treatment of pediatric PPCS.",2020,Symptoms improved over time with a median Post-Concussion Symptom Inventory change score of -21,"['Ninety-nine children (mean age: 13.8 years; SD = 2.6 years; 58% girls', 'Children With Postconcussive Symptoms', 'We included youth (ages 8-18 years) with PPCS at 4 to 6 weeks after mild traumatic brain injury']","['melatonin', 'placebo', 'Melatonin']","['total youth self-reported Post-Concussion Symptom Inventory score', 'Symptoms improved over time with a median Post-Concussion Symptom Inventory change score of -21', 'PPCS symptoms', 'quality of life', 'change in health-related quality of life, cognition, and sleep', 'Side effects']","[{'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517561', 'cui_str': '13.8 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517633', 'cui_str': 'Two point six'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C3508472', 'cui_str': 'Mild Traumatic Brain Injury'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0546983', 'cui_str': 'Post-Concussion Symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",99.0,0.792017,Symptoms improved over time with a median Post-Concussion Symptom Inventory change score of -21,"[{'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Barlow', 'Affiliation': ""Department of Pediatrics, Alberta Children's Hospital Research Institute and kbarlow@uq.edu.au.""}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Brooks', 'Affiliation': ""Department of Pediatrics, Alberta Children's Hospital Research Institute and.""}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Esser', 'Affiliation': ""Department of Pediatrics, Alberta Children's Hospital Research Institute and.""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Kirton', 'Affiliation': ""Department of Pediatrics, Alberta Children's Hospital Research Institute and.""}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Mikrogianakis', 'Affiliation': ""Department of Pediatrics, Alberta Children's Hospital Research Institute and.""}, {'ForeName': 'Roger L', 'Initials': 'RL', 'LastName': 'Zemek', 'Affiliation': ""Departments of Pediatrics and Emergency Medicine and Research Institute, Children's Hospital of Eastern Ontario and University of Ottawa, Ottawa, Ontario, Canada.""}, {'ForeName': 'Frank P', 'Initials': 'FP', 'LastName': 'MacMaster', 'Affiliation': ""Department of Pediatrics, Alberta Children's Hospital Research Institute and.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Nettel-Aguirre', 'Affiliation': ""Department of Pediatrics, Alberta Children's Hospital Research Institute and.""}, {'ForeName': 'Keith Owen', 'Initials': 'KO', 'LastName': 'Yeates', 'Affiliation': ""Department of Pediatrics, Alberta Children's Hospital Research Institute and.""}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Kirk', 'Affiliation': ""Department of Pediatrics, Alberta Children's Hospital Research Institute and.""}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Hutchison', 'Affiliation': 'Neurosciences and Mental Health Research Program, Department of Critical Care Medicine, The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Crawford', 'Affiliation': ""Neuroscience Program, Alberta Children's Hospital, Calgary, Alberta, Canada.""}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Turley', 'Affiliation': ""Neuroscience Program, Alberta Children's Hospital, Calgary, Alberta, Canada.""}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Cameron', 'Affiliation': 'Research Pharmacy, Foothills Medical Centre, Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hill', 'Affiliation': 'Clinical Neurosciences, Cumming School of Medicine and.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Samuel', 'Affiliation': ""Neuroscience Program, Alberta Children's Hospital, Calgary, Alberta, Canada.""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Buchhalter', 'Affiliation': ""Department of Pediatrics, Alberta Children's Hospital Research Institute and.""}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Richer', 'Affiliation': ""Department of Pediatrics and Women and Children's Health Research Institute, University of Alberta, Edmonton, Alberta, Canada.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Platt', 'Affiliation': 'McGill University, Montreal, Québec, Canada; and.'}, {'ForeName': 'Roslyn', 'Initials': 'R', 'LastName': 'Boyd', 'Affiliation': 'Child Health Research Centre, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Dewey', 'Affiliation': ""Department of Pediatrics, Alberta Children's Hospital Research Institute and.""}]",Pediatrics,['10.1542/peds.2019-2812']
616,31764108,High yield of new HIV diagnoses during active case-finding for tuberculosis.,"OBJECTIVE


To evaluate the utility of a broad and nonspecific symptom screen for identifying people with undiagnosed HIV infection.
DESIGN


Secondary analysis of operational data collected during implementation of a cluster-randomized trial for tuberculosis case detection.
METHODS


As part of the trial, adults reporting cough, fever, night sweats, weight loss, or difficulty breathing for any duration in the past month were identified in health facilities and community-based mobile screening units in western Kenya. Adults reporting any symptom were offered HIV testing. We analysed the HIV testing data from this study, using modified Poisson regression, to identify predictors of new HIV diagnoses among adults with symptoms and initially unknown HIV status.
RESULTS


We identified 3818 symptomatic adults, referred 1424 (37%) for testing, of whom 1065 (75%) accepted, and 107 (10%) were newly diagnosed with HIV. The prevalence of new HIV diagnoses was 21% [95% confidence interval (CI) 17-25%] among those tested in health facilities and 5% (95% CI 4-7%) among those tested in mobile units. More men were diagnosed with HIV than women, despite fewer men being screened. People who reported 4-5 symptoms were over twice as likely to be diagnosed with HIV compared to those reporting 1-3 symptoms (adjusted prevalence ratio in health facilities = 2.58, 95% CI 1.65-4.05; adjusted prevalence ratio in mobile units = 2.63, 95% CI 1.37-5.03).
CONCLUSION


We observed a high yield of new HIV diagnoses among adults identified by active application of a broad symptom screen. Use of integrated tuberculosis and HIV screening could help close the detection gap for both conditions.",2019,The prevalence of new HIV diagnoses was 21% [95% confidence interval (CI) 17-25%] among those tested in health facilities and 5% (95% CI 4-7%) among those tested in mobile units.,"['3818 symptomatic adults, referred 1424 (37%) for testing, of whom 1065 (75%) accepted, and 107 (10%) were newly diagnosed with HIV', 'adults with symptoms and initially unknown HIV status', 'adults reporting cough, fever, night sweats, weight loss, or difficulty breathing for any duration in the past month were identified in health facilities and community-based mobile screening units in western Kenya', 'people with undiagnosed HIV infection']",['integrated tuberculosis and HIV screening'],['prevalence of new HIV diagnoses'],"[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0028081', 'cui_str': 'Night sweats (finding)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0018704', 'cui_str': 'Health Facilities'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}]","[{'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0459958', 'cui_str': 'HIV screening test'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]",,0.435401,The prevalence of new HIV diagnoses was 21% [95% confidence interval (CI) 17-25%] among those tested in health facilities and 5% (95% CI 4-7%) among those tested in mobile units.,"[{'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Mchembere', 'Affiliation': 'Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Agaya', 'Affiliation': 'Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Courtney M', 'Initials': 'CM', 'LastName': 'Yuen', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Okelloh', 'Affiliation': 'Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Millicent', 'Initials': 'M', 'LastName': 'Achola', 'Affiliation': 'Kenya Medical Research Institute, US Army Medical Research Directorate - Kenya, Kisumu, Kenya.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Opole', 'Affiliation': 'Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Cowden', 'Affiliation': 'US Army Medical Research Directorate - Kenya.'}, {'ForeName': 'Hellen', 'Initials': 'H', 'LastName': 'Muttai', 'Affiliation': 'Centers for Disease Control and Prevention, Kisumu, Kenya.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Heilig', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Martien W', 'Initials': 'MW', 'LastName': 'Borgdorff', 'Affiliation': 'Centers for Disease Control and Prevention, Kisumu, Kenya.'}, {'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Cain', 'Affiliation': 'Centers for Disease Control and Prevention, Kisumu, Kenya.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002354']
617,22374991,"Gastric cancer incidence among Hispanics in California: patterns by time, nativity, and neighborhood characteristics.","BACKGROUND


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


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


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


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


Age, sex, birthplace, SES, and acculturation modify gastric cancer incidence in Hispanics and should be considered when examining disease risk and prevention.",2012,"During the same time period, incidence rates of intestinal gastric cancer declined significantly and both cardia and noncardia gastric cancer were steady or declined among foreign-born and U.S.-born Hispanic men and women.","['foreign-born Hispanic men and U.S.-born Hispanic women', 'younger and middle-aged Hispanic men, cardia tumors', 'Hispanics in California']",[],"['Noncardia and both intestinal and diffuse gastric cancer', 'Incidence rates', 'time, nativity, and neighborhood characteristics', 'cardia and noncardia gastric cancer', 'Incidence rates of diffuse gastric cancer', 'Incidence rates, rate ratios, and estimated annual percent change (EAPC) in rates of anatomic and histologic subtype-specific gastric cancer', 'Gastric cancer incidence', 'incidence rates of intestinal gastric cancer']","[{'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0007144', 'cui_str': 'Cardia'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0006754', 'cui_str': 'California'}]",[],"[{'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0205219', 'cui_str': 'Diffuse (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0007144', 'cui_str': 'Cardia'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",,0.019428,"During the same time period, incidence rates of intestinal gastric cancer declined significantly and both cardia and noncardia gastric cancer were steady or declined among foreign-born and U.S.-born Hispanic men and women.","[{'ForeName': 'Ellen T', 'Initials': 'ET', 'LastName': 'Chang', 'Affiliation': 'Cancer Prevention Institute of California, Fremont, CA, USA. echang@exponent.com'}, {'ForeName': 'Scarlett Lin', 'Initials': 'SL', 'LastName': 'Gomez', 'Affiliation': ''}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Fish', 'Affiliation': ''}, {'ForeName': 'Clayton W', 'Initials': 'CW', 'LastName': 'Schupp', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Parsonnet', 'Affiliation': ''}, {'ForeName': 'Mindy C', 'Initials': 'MC', 'LastName': 'DeRouen', 'Affiliation': ''}, {'ForeName': 'Theresa H M', 'Initials': 'TH', 'LastName': 'Keegan', 'Affiliation': ''}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Clarke', 'Affiliation': ''}, {'ForeName': 'Sally L', 'Initials': 'SL', 'LastName': 'Glaser', 'Affiliation': ''}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-11-1208']
618,32170769,Bortezomib consolidation or maintenance following immunochemotherapy and autologous stem cell transplantation for mantle cell lymphoma: CALGB/Alliance 50403.,"Immunochemotherapy followed by autologous transplant (ASCT) in CALGB/Alliance 59909 achieved a median progression-free survival (PFS) in mantle cell lymphoma (MCL) of 5 years, but late recurrences occurred. We evaluated tolerability and efficacy of adding post-transplant bortezomib consolidation (BC) or maintenance (BM) to this regimen in CALGB/Alliance 50403, a randomized phase II trial. Following augmented-dose R-CHOP/ methotrexate, high-dose cytarabine-based stem cell mobilization, cyclophosphamide/carmustine/etoposide (CBV) autotransplant, and rituximab, patients were randomized to BC (1.3 mg/m 2  IV days 1, 4, 8, 11 of a 3-week cycle for four cycles) or BM (1.6 mg/m 2  IV once weekly × 4 every 8 weeks for 18 months) beginning day 90. The primary endpoint was PFS, measured from randomization for each arm. Proliferation signature, Ki67, and postinduction minimal residual disease (MRD) in bone marrow were assessed. Of 151 patients enrolled; 118 (80%) underwent ASCT, and 102 (68%) were randomized. Both arms met the primary endpoint, with median PFS significantly greater than 4 years (P < .001). The 8-year PFS estimates in the BC and BM arms were 54.1% (95% CI 40.9%-71.5%) and 64.4% (95% 51.8%-79.0%), respectively. Progression-free survival was significantly longer for transplanted patients on 50403 compared with those on 59909. Both the PFS and OS were significantly better for those who were MRD-negative post-induction. The high risk proliferation signature was associated with adverse outcome. Both BM and BC were efficacious and tolerable, although toxicity was significant. The comparison between studies 50403 and 59909 with long-term follow up suggests a PFS benefit from the addition of BC or BM post- transplant.",2020,"Both arms met the primary endpoint, with median PFS significantly greater than 4 years (p < 0.001).","['151 patients enrolled; 118 (80%) underwent ASCT, and 102 (68%) were randomized']","['Immunochemotherapy and Autologous Stem Cell Transplantation', 'Immunochemotherapy followed by autologous transplant (ASCT', 'adding post-transplant bortezomib consolidation (BC) or maintenance (BM', 'Bortezomib Consolidation or Maintenance', 'augmented-dose R-CHOP/ methotrexate, high-dose cytarabine-based stem cell mobilization, cyclophosphamide/carmustine/etoposide (CBV) autotransplant, and rituximab']","['8-year PFS estimates', 'Proliferation signature, Ki67, and postinduction minimal residual disease (MRD) in bone marrow', 'PFS and OS', 'toxicity', 'median progression-free survival (PFS', 'PFS', 'tolerability and efficacy', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517542', 'cui_str': '118'}]","[{'cui': 'C4087148', 'cui_str': 'Immunochemotherapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0559189', 'cui_str': 'Autotransplants'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0524864', 'cui_str': 'Stem Cell Mobilization'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0007257', 'cui_str': 'Carmustine'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0334094', 'cui_str': 'Proliferation (morphologic abnormality)'}, {'cui': 'C0242596', 'cui_str': 'Minimal Disease, Residual'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",151.0,0.0888476,"Both arms met the primary endpoint, with median PFS significantly greater than 4 years (p < 0.001).","[{'ForeName': 'Lawrence D', 'Initials': 'LD', 'LastName': 'Kaplan', 'Affiliation': 'Medicine/Hematology-Oncology, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Maurer', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Stock', 'Affiliation': 'Medicine, University of Chicago Comprehensive Cancer Center, Chicago, Illinois, USA.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Bartlett', 'Affiliation': 'Siteman Cancer Center, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Noreen', 'Initials': 'N', 'LastName': 'Fulton', 'Affiliation': 'Medicine, University of Chicago Comprehensive Cancer Center, Chicago, Illinois, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Pettinger', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Byrd', 'Affiliation': 'Hematology, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Kristie A', 'Initials': 'KA', 'LastName': 'Blum', 'Affiliation': 'Hematology, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Ann S', 'Initials': 'AS', 'LastName': 'LaCasce', 'Affiliation': 'Medical Oncology, Dana-Farber/Partners CancerCare, Boston, Massachusetts, USA.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Hsi', 'Affiliation': 'Department of Laboratory Medicine, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Yi Tian', 'Initials': 'YT', 'LastName': 'Liu', 'Affiliation': 'Centre for Lymphoid Cancer, British Columbia Cancer, Vancouver, British Columbia, Canada.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Scott', 'Affiliation': 'Centre for Lymphoid Cancer, British Columbia Cancer, Vancouver, British Columbia, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hurd', 'Affiliation': 'Hematology-Oncology, Wake Forest University Health Sciences, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Ruppert', 'Affiliation': 'Alliance Statistics and Data Center, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Hernandez-Ilizaliturri', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, New York, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Leonard', 'Affiliation': 'Department of Medicine, Weill Medical College of Cornell University, New York, New York, USA.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Cheson', 'Affiliation': 'Hematology-Oncology, MedStar Georgetown University Hospital, Washington, District of Columbia, USA.'}]",American journal of hematology,['10.1002/ajh.25783']
619,32210455,"Comparison of the pain-reducing effects of EMLA cream and of lidocaine tape during arteriovenous fistula puncture in patients undergoing hemodialysis: A multi-center, open-label, randomized crossover trial.","Arteriovenous fistula puncture pain is a serious problem for patients undergoing dialysis and a good indication for topical anesthetics. No previous study has compared lidocaine/prilocaine cream (EMLA) with lidocaine tape for pain relief during arteriovenous fistula puncture in patients undergoing maintenance hemodialysis. To this end, we conducted a multicenter randomized crossover study including 66 patients (mean age, 65.8 years; males, 57.6%) undergoing maintenance hemodialysis thrice/week. Subjects were assigned to Sequence EL (EMLA administration followed by lidocaine, with 1-week wash-out) or Sequence LE (reverse administration, first lidocaine then EMLA). All subjects completed the study. At each puncture site, 1 g EMLA (25 mg lidocaine + 25 mg prilocaine) or one sheet of lidocaine tape (18 mg lidocaine) was applied 1 h or 30 min prior to arteriovenous fistula puncture, respectively. The primary endpoint was puncture pain relief, which was measured using a 100-mm visual analog scale. The secondary endpoints included quality of life, which was measured by SF-36, and safety. EMLA produced a 10.1-mm greater visual analog scale improvement than lidocaine tape (P = 0.00001). However, there was no statistically significant difference in the quality of life between the two groups, and no significant carryover/period effect was observed in any analysis. Further, no drug-related adverse events were observed. Taken together, these results suggest that EMLA cream is superior to lidocaine tape for the relief of arteriovenous fistula puncture pain in patients undergoing maintenance hemodialysis. Trial registration: University Hospital Medical Information Network Clinical Trials Registry (UMIN000027885).",2020,EMLA produced a 10.1-mm greater visual analog scale improvement than lidocaine tape (P = 0.00001).,"['patients undergoing maintenance hemodialysis', 'patients undergoing dialysis and a good indication for topical anesthetics', 'patients undergoing hemodialysis', '66 patients (mean age, 65.8 years; males, 57.6%) undergoing maintenance hemodialysis thrice/week']","['lidocaine/prilocaine cream (EMLA', 'Sequence EL (EMLA administration followed by lidocaine, with 1-week wash-out) or Sequence LE (reverse administration, first lidocaine then EMLA', 'lidocaine tape (18 mg lidocaine', 'Arteriovenous fistula puncture pain', 'EMLA', 'lidocaine + 25 mg prilocaine', 'EMLA cream', 'lidocaine tape', 'lidocaine']","['quality of life, which was measured by SF-36, and safety', 'quality of life', 'pain relief', 'puncture pain relief, which was measured using a 100-mm visual analog scale', 'arteriovenous fistula puncture pain', 'visual analog scale improvement']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0040464', 'cui_str': 'Topical anesthetic (substance)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0617623', 'cui_str': 'Lidocaine / Prilocaine'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0059079', 'cui_str': 'EMLA'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C1704747', 'cui_str': 'Tape (basic dose form)'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula (morphologic abnormality)'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033124', 'cui_str': 'Prilocaine'}, {'cui': 'C0360032', 'cui_str': 'EMLA Cream'}]","[{'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula (morphologic abnormality)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",66.0,0.0558131,EMLA produced a 10.1-mm greater visual analog scale improvement than lidocaine tape (P = 0.00001).,"[{'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Fujimoto', 'Affiliation': 'Department of Nephrology, Kanazawa Medical University School of Medicine, Ishikawa, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Adachi', 'Affiliation': 'Department of Nephrology, Kanazawa Medical University School of Medicine, Ishikawa, Japan.'}, {'ForeName': 'Keita', 'Initials': 'K', 'LastName': 'Yamazaki', 'Affiliation': 'Keiju Medical Center, Ishikawa, Japan.'}, {'ForeName': 'Kanae', 'Initials': 'K', 'LastName': 'Nomura', 'Affiliation': 'Department of Nephrology, Kanazawa Medical University School of Medicine, Ishikawa, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Saito', 'Affiliation': 'Kanazawa Medical University Himi Municipal Hospital, Toyama, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Matsumoto', 'Affiliation': 'Honma Hospital, Yamagata, Japan.'}, {'ForeName': 'Kazunari', 'Initials': 'K', 'LastName': 'Igarashi', 'Affiliation': 'Honma Hospital, Yamagata, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Uranishi', 'Affiliation': 'Anamizu General Hospital, Ishikawa, Japan.'}, {'ForeName': 'Suga', 'Initials': 'S', 'LastName': 'Sakaguchi', 'Affiliation': 'Anamizu General Hospital, Ishikawa, Japan.'}, {'ForeName': 'Toshikazu', 'Initials': 'T', 'LastName': 'Matsuura', 'Affiliation': 'Department of Nephrology, Kanazawa Medical University School of Medicine, Ishikawa, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Imura', 'Affiliation': 'Imura Clinic, Ishikawa, Japan.'}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Okino', 'Affiliation': 'Department of Nephrology, Kanazawa Medical University School of Medicine, Ishikawa, Japan.'}, {'ForeName': 'Kiyotaka', 'Initials': 'K', 'LastName': 'Mukai', 'Affiliation': 'Department of Nephrology, Kanazawa Medical University School of Medicine, Ishikawa, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Okushi', 'Affiliation': 'Department of Nephrology, Kanazawa Medical University School of Medicine, Ishikawa, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Kagaya', 'Affiliation': 'Keiju Medical Center, Ishikawa, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Tsuruyama', 'Affiliation': 'Department of Nephrology, Kanazawa Medical University School of Medicine, Ishikawa, Japan.'}, {'ForeName': 'Keiichiro', 'Initials': 'K', 'LastName': 'Okada', 'Affiliation': 'Department of Nephrology, Kanazawa Medical University School of Medicine, Ishikawa, Japan.'}, {'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Miyatake', 'Affiliation': 'Department of Nephrology, Kanazawa Medical University School of Medicine, Ishikawa, Japan.'}, {'ForeName': 'Takatoshi', 'Initials': 'T', 'LastName': 'Haraguchi', 'Affiliation': 'Kanazawa Medical University Himi Municipal Hospital, Toyama, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Iida', 'Affiliation': 'Department of Mathematics, Kanazawa Medical University, Ishikawa Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Yokoyama', 'Affiliation': 'Department of Nephrology, Kanazawa Medical University School of Medicine, Ishikawa, Japan.'}]",PloS one,['10.1371/journal.pone.0230372']
620,32214333,Electronic charts do not facilitate the recognition of patient hazards by advanced medical students: A randomized controlled study.,"Chart review is an important tool to identify patient hazards. Most advanced medical students perform poorly during chart review but can learn how to identify patient hazards context-independently. Many hospitals have implemented electronic health records, which enhance patient safety but also pose challenges. We investigated whether electronic charts impair advanced medical students' recognition of patient hazards compared with traditional paper charts. Fifth-year medical students were randomized into two equal groups. Both groups attended a lecture on patient hazards and a training session on handling electronic health records. One group reviewed an electronic chart with 12 standardized patient hazards and then reviewed another case in a paper chart; the other group reviewed the charts in reverse order. The two case scenarios (diabetes and gastrointestinal bleeding) were used as the first and second case equally often. After each case, the students were briefed about the patient safety hazards. In total, 78.5% of the students handed in their notes for evaluation. Two blinded raters independently assessed the number of patient hazards addressed in the students' notes. For the diabetes case, the students identified a median of 4.0 hazards [25%-75% quantiles (Q25-Q75): 2.0-5.5] in the electronic chart and 5.0 hazards (Q25-Q75: 3.0-6.75) in the paper chart (equivalence testing, p = 0.005). For the gastrointestinal bleeding case, the students identified a median of 5.0 hazards (Q25-Q75: 4.0-6.0) in the electronic chart and 5.0 hazards (Q25-Q75: 3.0-6.0) in the paper chart (equivalence testing, p < 0.001). We detected no improvement between the first case [median 5.0 (Q25-Q75: 3.0-6.0)] and second case [median, 5.0 (Q25-Q75: 3.0-6.0); p < 0.001, test for equivalence]. Electronic charts do not seem to facilitate advanced medical students' recognition of patient hazards during chart review and may impair expertise formation.",2020,Electronic charts do not seem to facilitate advanced medical students' recognition of patient hazards during chart review and may impair expertise formation.,"['advanced medical students', 'Fifth-year medical students']",[],[],"[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],[],,0.0199588,Electronic charts do not seem to facilitate advanced medical students' recognition of patient hazards during chart review and may impair expertise formation.,"[{'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Holderried', 'Affiliation': 'Department of Anaesthesiology, University Hospital Tübingen, Tübingen, Baden-Württemberg, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Herrmann-Werner', 'Affiliation': 'Department of Internal Medicine VI, Psychosomatic Medicine, University Hospital Tübingen, Baden-Württemberg, Tübingen, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Mahling', 'Affiliation': 'Department of Diabetology, Endocrinology, Nephrology, Section of Nephrology and Hypertension, University Hospital Tübingen, Tübingen, Baden-Württemberg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Holderried', 'Affiliation': 'Department of Quality Management, Medical and Business Development, University Hospital of Tübingen, Tübingen, Baden-Württemberg, Germany.'}, {'ForeName': 'Reimer', 'Initials': 'R', 'LastName': 'Riessen', 'Affiliation': 'Department of Internal Medicine VIII, Intensive Care Unit, University Hospital Tübingen, Tübingen, Baden-Württemberg, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Zipfel', 'Affiliation': 'Department of Internal Medicine VI, Psychosomatic Medicine, University Hospital Tübingen, Baden-Württemberg, Tübingen, Germany.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Celebi', 'Affiliation': 'PHV Dialysis Center Waiblingen, Waiblingen, Germany.'}]",PloS one,['10.1371/journal.pone.0230522']
621,32240480,"The Effectiveness of the KiVa Bullying Prevention Program in Wales, UK: Results from a Pragmatic Cluster Randomized Controlled Trial.","The study evaluated the implementation fidelity and effectiveness of KiVa, an evidence-based program that aims to prevent and address bullying in schools, with a particular emphasis on changing the role of bystanders. The study was a two-arm waitlist control cluster randomized controlled trial in which 22 primary schools (clusters) (N = 3214 students aged 7-11) were allocated using a 1:1 ratio to intervention (KiVa; 11 clusters, n = 1588 students) and a waitlist control (usual school provision; 11 clusters, n = 1892 children)). The trial statistician (but not schools or researchers) remained blind to allocation status. The outcomes were as follows: student-reported victimization (primary outcome) and bullying perpetration; teacher-reported child behavior and emotional well-being; and school absenteeism (administrative records). Implementation fidelity was measured using teacher-completed online records (for class lessons) and independent researcher observations (for school-wide elements). Outcome analyses involved 11 intervention schools (n = 1578 children) and 10 control schools (n = 1636 children). There was no statistically significant effect on the primary outcome of child-reported victimization (adjusted intervention/control OR 0.76; 95% CI 0.55 to 1.06; p = 0.11) or on the secondary outcomes. The impact on victimization was not moderated by child gender, age, or victimization status at baseline. Lesson adherence was good but exposure (lesson length) was lower than the recommended amount, and there was considerable variability in the implementation of whole school elements. The trial found insufficient evidence to conclude that KiVa had an effect on the primary outcome. A larger trial of KiVa in the UK is warranted, however, with attention to issues regarding implementation fidelity. Trial registration: Current Controlled Trials ISRCTN23999021 Date 10-6-13.",2020,There was no statistically significant effect on the primary outcome of child-reported victimization (adjusted intervention/control OR 0.76; 95% CI 0.55 to 1.06; p = 0.11) or on the secondary outcomes.,"['22 primary schools (clusters) (N\u2009=\u20093214 students aged 7-11', '11 intervention schools (n\u2009=\u20091578 children) and 10 control schools (n\u2009=\u20091636 children', 'Wales, UK']","['KiVa', 'KiVa Bullying Prevention Program', 'waitlist control']","['Implementation fidelity', 'Lesson adherence', 'student-reported victimization (primary outcome) and bullying perpetration; teacher-reported child behavior and emotional well-being; and school absenteeism (administrative records']","[{'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043015', 'cui_str': 'Wales'}]","[{'cui': 'C0424318', 'cui_str': 'Bullying'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0424318', 'cui_str': 'Bullying'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C1301664', 'cui_str': 'Administrative record'}]",3214.0,0.160181,There was no statistically significant effect on the primary outcome of child-reported victimization (adjusted intervention/control OR 0.76; 95% CI 0.55 to 1.06; p = 0.11) or on the secondary outcomes.,"[{'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Axford', 'Affiliation': 'NIHR ARC South West Peninsula (PenARC), University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Bjornstad', 'Affiliation': 'University of Exeter Medical School, University of Exeter, Exeter, UK.'}, {'ForeName': 'Suzy', 'Initials': 'S', 'LastName': 'Clarkson', 'Affiliation': 'Bangor University, Bangor, UK.'}, {'ForeName': 'Obioha C', 'Initials': 'OC', 'LastName': 'Ukoumunne', 'Affiliation': 'PenARC, University of Exeter, Exeter, UK. o.c.ukoumunne@exeter.ac.uk.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Wrigley', 'Affiliation': 'University of Cardiff, Cardiff, UK.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Matthews', 'Affiliation': 'PenARC, University of Exeter, Exeter, UK.'}, {'ForeName': 'Vashti', 'Initials': 'V', 'LastName': 'Berry', 'Affiliation': 'PenARC, University of Exeter, Exeter, UK.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Hutchings', 'Affiliation': 'Bangor University, Bangor, UK.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01103-9']
622,32243885,A High-Definition tDCS and EEG study on attention and vigilance: Brain stimulation mitigates the executive but not the arousal vigilance decrement.,"Attention comprises a wide set of processes such as phasic alertness, orienting, executive control, and the executive (i.e., detecting infrequent targets) and arousal (i.e., sustaining a fast reaction) vigilance components. Importantly, the effects of transcranial direct current stimulation (tDCS) over attentional functioning have been mostly addressed by measuring these processes separately and by delivering offline tDCS with low precision over the stimulation region. In the current study, we examined the effects of online High-Definition tDCS (HD-tDCS) over the behavioral and electrophysiological functioning of attentional and vigilance components. Participants (N = 92) were randomly assigned to one of three stimulation groups: right dorsolateral prefrontal cortex stimulation, right posterior parietal cortex (PPC) stimulation, and sham. All of them performed - in combination with the HD-tDCS protocol - an attentional networks task (ANTI-Vea) suitable to measure the executive and arousal components of vigilance along with three typical attentional functions: phasic alertness, orienting, and executive control. In addition, EEG was registered at the baseline and at the post-stimulation period. We observed that, regardless the stimulation region, online HD-tDCS: (a) reduced phasic alertness (p = .008), but did not modulated the orienting and executive control functioning; and (b) mitigated the executive vigilance decrement (p = .011), but did not modulated arousal vigilance across time-on-task. Interestingly, only HD-tDCS over PPC reduced considerably the increment of alpha power observed across time-on-task (p = .009). The current study provides further evidence for both an empirical dissociation between vigilance components and the cortical regions underlying attentional processes. We highlight the advantages of using online HD-tDCS to examine the stimulation effects on attentional and vigilance functioning.",2020,"We observed that, regardless the stimulation region, online HD-tDCS: (a) reduced phasic alertness (p = .008), but did not modulated the orienting and executive control functioning; and (b) mitigated the executive vigilance decrement (p = .011), but did not modulated arousal vigilance across time-on-task.",['Participants (N\u202f=\u202f92'],"['right dorsolateral prefrontal cortex stimulation, right posterior parietal cortex (PPC) stimulation, and sham', 'transcranial direct current stimulation (tDCS', 'online High-Definition tDCS (HD-tDCS']","['arousal vigilance', 'attention and vigilance', 'attentional and vigilance functioning', 'executive vigilance decrement', 'phasic alertness']",[],"[{'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0456855', 'cui_str': 'Right posterior'}, {'cui': 'C0030560', 'cui_str': 'Parietal lobe structure'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}]","[{'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",92.0,0.0261973,"We observed that, regardless the stimulation region, online HD-tDCS: (a) reduced phasic alertness (p = .008), but did not modulated the orienting and executive control functioning; and (b) mitigated the executive vigilance decrement (p = .011), but did not modulated arousal vigilance across time-on-task.","[{'ForeName': 'Fernando G', 'Initials': 'FG', 'LastName': 'Luna', 'Affiliation': 'Instituto de Investigaciones Psicológicas (IIPsi), CONICET-UNC. Facultad de Psicología, Universidad Nacional de Córdoba, Boulevard de la Reforma esquina Enfermera Gordillo, CP, 5000, Córdoba, Argentina(1); Department of Experimental Psychology, and Mind, Brain, and Behavior Research Center (CIMCYC), University of Granada, Campus de Cartuja S/N, CP, 18011, Granada, Spain. Electronic address: fluna@unc.edu.ar.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Román-Caballero', 'Affiliation': 'Department of Experimental Psychology, and Mind, Brain, and Behavior Research Center (CIMCYC), University of Granada, Campus de Cartuja S/N, CP, 18011, Granada, Spain. Electronic address: rrarroca@ugr.es.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Barttfeld', 'Affiliation': 'Instituto de Investigaciones Psicológicas (IIPsi), CONICET-UNC. Facultad de Psicología, Universidad Nacional de Córdoba, Boulevard de la Reforma esquina Enfermera Gordillo, CP, 5000, Córdoba, Argentina(1). Electronic address: pablob@conicet.gov.ar.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Lupiáñez', 'Affiliation': 'Department of Experimental Psychology, and Mind, Brain, and Behavior Research Center (CIMCYC), University of Granada, Campus de Cartuja S/N, CP, 18011, Granada, Spain. Electronic address: jlupiane@ugr.es.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Martín-Arévalo', 'Affiliation': 'Department of Experimental Psychology, and Mind, Brain, and Behavior Research Center (CIMCYC), University of Granada, Campus de Cartuja S/N, CP, 18011, Granada, Spain. Electronic address: emartina@ugr.es.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2020.107447']
623,31234104,A multicentre prospective randomised controlled clinical trial comparing the effectiveness and cost of a static air mattress and alternating air pressure mattress to prevent pressure ulcers in nursing home residents.,"BACKGROUND


Pressure ulcers are a global issue and substantial concern for healthcare systems. Various types of support surfaces that prevent pressure ulcer are available. Data about the effectiveness and cost of static air support surfaces and alternating air pressure mattresses is lacking.
OBJECTIVES


To compare the effectiveness and cost of static air support surfaces versus alternating air pressure support surfaces in a nursing home population at high risk for pressure ulcers.
DESIGN


Prospective, multicentre, randomised controlled clinical, non-inferiority trial.
SETTING


Twenty-six nursing homes in Flanders, Belgium.
PARTICIPANTS


A consecutive sample of 308 participants was selected based on the following eligibility criteria: high risk for pressure ulcer and/or with category 1 pressure ulcer, being bedbound and/or chair bound, aged > 65 years, and use of an alternating air pressure mattress.
METHODS


The participants were allocated to the intervention group (n = 154) using static air support surfaces and the control group (n = 154) using alternating air pressure support surfaces. The main outcome measures were cumulative incidence and incidence density of the participants developing a new category II-IV pressure ulcer within a 14-day observation period, time to develop a new pressure ulcer, and purchase costs of the support surfaces.
RESULTS


The intention-to-treat analysis revealed a significantly lower incidence of category II-IV pressure ulcer in the intervention group (n = 8/154, 5.2%) than in the control group (n = 18/154, 11.7%) (p = 0.04). The median time to develop a pressure ulcer was significantly longer in the intervention group (10.5 days, interquartile range [IQR]: 1-14) than in the control group (5.4 days, [IQR]: 1-12; p = 0.05). The probability to remain pressure ulcer free differed significantly between the two study groups (log-rank X² = 4.051, df = 1, p = 0.04). The overall cost of the mattress was lower in the intervention group than in the control group.
CONCLUSIONS


A static air mattress was significantly more effective than an alternating air pressure mattress in preventing pressure ulcer in a high-risk nursing home population. Considering multiple lifespans and purchase costs, static air mattresses were more cost-effective than alternating air pressure mattresses.",2019,"Considering multiple lifespans and purchase costs, static air mattresses were more cost-effective than alternating air pressure mattresses.","['nursing home population at high risk for pressure ulcers', 'Twenty-six nursing homes in Flanders, Belgium', 'nursing home residents', 'A consecutive sample of 308 participants was selected based on the following eligibility criteria: high risk for pressure ulcer and/or with category 1 pressure ulcer, being bedbound and/or chair bound, aged > 65 years, and use of an alternating air pressure mattress']","['alternating air pressure mattress', 'static air support surfaces versus alternating air pressure support surfaces', 'static air mattress and alternating air pressure mattress', 'static air support surfaces and the control group (n\u202f=\u202f154) using alternating air pressure support surfaces']","['incidence of category II-IV pressure ulcer', 'median time to develop a pressure ulcer', 'probability to remain pressure ulcer free', 'cumulative incidence and incidence density of the participants developing a new category II-IV pressure ulcer within a 14-day observation period, time to develop a new pressure ulcer, and purchase costs of the support surfaces', 'overall cost of the mattress']","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0011127', 'cui_str': 'Pressure Ulcer'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C1875156', 'cui_str': 'Flanders'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0425251', 'cui_str': 'Bed-ridden (finding)'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}, {'cui': 'C0001876', 'cui_str': 'Air Pressure'}, {'cui': 'C0024940', 'cui_str': 'Mattresses'}]","[{'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}, {'cui': 'C0001876', 'cui_str': 'Air Pressure'}, {'cui': 'C0024940', 'cui_str': 'Mattresses'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011127', 'cui_str': 'Pressure Ulcer'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0024940', 'cui_str': 'Mattresses'}]",308.0,0.0641788,"Considering multiple lifespans and purchase costs, static air mattresses were more cost-effective than alternating air pressure mattresses.","[{'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Beeckman', 'Affiliation': 'Skin Integrity Research Group (SKINT), University Centre for Nursing and Midwifery, Department of Public Health and Primary Care, Faculty of Medicine and Health Sciences, Ghent University, Belgium; School of Nursing and Midwifery, Royal College of Surgeons in Ireland, Ireland; School of Health Sciences, Örebro University, Sweden; Research Unit of Plastic Surgery, Department of Clinical Research, Faculty of Health Sciences, Southern Denmark; School of Nursing and Midwifery, Monash University, Australia. Electronic address: Dimitri.Beeckman@UGent.be.'}, {'ForeName': 'Brecht', 'Initials': 'B', 'LastName': 'Serraes', 'Affiliation': 'Skin Integrity Research Group (SKINT), University Centre for Nursing and Midwifery, Department of Public Health and Primary Care, Faculty of Medicine and Health Sciences, Ghent University, Belgium; Nursing department (General Hospital) AZ Nikolaas, Hospitaalstraat 1, B-9100 Sint-Niklaas, Belgium. Electronic address: Brecht.Serraes@UGent.be.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Anrys', 'Affiliation': 'Skin Integrity Research Group (SKINT), University Centre for Nursing and Midwifery, Department of Public Health and Primary Care, Faculty of Medicine and Health Sciences, Ghent University, Belgium. Electronic address: Charlotte.Anrys@UGent.be.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Van Tiggelen', 'Affiliation': 'Skin Integrity Research Group (SKINT), University Centre for Nursing and Midwifery, Department of Public Health and Primary Care, Faculty of Medicine and Health Sciences, Ghent University, Belgium. Electronic address: Hanne.VanTiggelen@UGent.be.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Van Hecke', 'Affiliation': 'Skin Integrity Research Group (SKINT), University Centre for Nursing and Midwifery, Department of Public Health and Primary Care, Faculty of Medicine and Health Sciences, Ghent University, Belgium. Electronic address: Ann.VanHecke@UGent.be.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Verhaeghe', 'Affiliation': 'Skin Integrity Research Group (SKINT), University Centre for Nursing and Midwifery, Department of Public Health and Primary Care, Faculty of Medicine and Health Sciences, Ghent University, Belgium. Electronic address: Sofie.Verhaeghe@UGent.be.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2019.05.015']
624,32061969,Athletes for life: Rationale and methodology of a community- and family-based randomized controlled trial to promote cardiovascular fitness among primarily Latino families.,"BACKGROUND


Community-based programs have had modest success in combating obesity in Latino populations. Latino families' norms and beliefs about weight often hold larger body sizes to be normal, leading to lower engagement in weight-focused programs. Because improvements in cardiorespiratory fitness confer health benefits, regardless of weight, they offer an alternative to obesity-focused approaches. We describe the rationale and design of Athletes for Life (AFL), a community- and family-based intervention for Latino families.
METHODS/DESIGN


This two-group randomized controlled trial will test the efficacy of AFL for improving cardiorespiratory fitness and diet in 6- to 11-year-old children (N = 160) and their parents, relative to a wait-list control group. Children will participate in 12 weeks of semiweekly sports skill programing and nutrition sessions. Concurrently, parents will participate in sports-focused activity and behavior change sessions that focus on nutrition, chronic disease prevention, and healthy eating. Cardiovascular fitness will be measured by the 1-mile run and 3-min step-test for both parents and children. Secondary outcomes include changes in objectively measured physical activity, dietary measures, body composition, and cardiometabolic risk (waist circumference, blood pressure, blood lipids, glucose, insulin, and C-reactive protein).
DISCUSSION


AFL, implemented with a strong community partnership, will provide a test of the efficacy of culturally tailored intervention programming to promote positive health behaviors and improve health outcomes in Latino families. Intervention content, structure, and messaging will provide guidance for future methods to engage Latino families in health promotion programs that highlight their cultural norms, and beliefs.
TRIAL REGISTRATION


Clinicaltrials.gov Identifier NCT03761589 (12/3/2018).",2020,"Latino families' norms and beliefs about weight often hold larger body sizes to be normal, leading to lower engagement in weight-focused programs.","['Latino families', '6- to 11-year-old children (N\u202f=\u202f160) and their parents, relative to a wait-list control group', 'Latino populations', 'Athletes for Life (AFL), a community- and family-based intervention for Latino families', 'primarily Latino families']","['semiweekly sports skill programing and nutrition sessions', 'AFL']","['changes in objectively measured physical activity, dietary measures, body composition, and cardiometabolic risk (waist circumference, blood pressure, blood lipids, glucose, insulin, and C-reactive protein', 'cardiorespiratory fitness and diet', 'health outcomes', 'Cardiovascular fitness']","[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.040074,"Latino families' norms and beliefs about weight often hold larger body sizes to be normal, leading to lower engagement in weight-focused programs.","[{'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Szeszulski', 'Affiliation': 'Arizona State University, College of Health Solutions, 550 North 3rd Street, Phoenix, AZ 85004, USA; The University of Texas Health Science Center at Houston, Center for Health Promotion and Prevention Research, 7000 Fannin Street, #1200, Houston, TX 77030, USA; The University of Texas Health Science Center at Houston, Austin Campus, Michael Susan Dell Center for Healthy Living, 1616 Guadalupe Street, Suite 6.300, Austin, TX 78701, USA.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Vega-López', 'Affiliation': 'Arizona State University, College of Health Solutions, 550 North 3rd Street, Phoenix, AZ 85004, USA; Arizona State University, Southwest Interdisciplinary Research Center, School of Social Work, Watts College of Public Service & Community Solutions, 201 North Central Avenue, 33rd Floor, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Todd', 'Affiliation': 'Arizona State University, Edson College of Nursing and Health Innovation, 550 North 3rd Street, Suite 301, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Ray', 'Affiliation': 'City of Phoenix Parks and Recreation, 212 East Alta Vista Rd, Phoenix, AZ 85042, USA.'}, {'ForeName': 'Alma', 'Initials': 'A', 'LastName': 'Behar', 'Affiliation': 'San Diego State University, School of Public Health, 5500 Campanile Drive, San Diego, CA 92182, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Campbell', 'Affiliation': 'Arizona State University, College of Health Solutions, 550 North 3rd Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Chavez', 'Affiliation': 'Arizona State University, College of Health Solutions, 550 North 3rd Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Eckert', 'Affiliation': 'Arizona State University, College of Health Solutions, 550 North 3rd Street, Phoenix, AZ 85004, USA; Mays Cancer Center at UT Health San Antonio MD Anderson, 7979 Wurzbach Rd, San Antonio, TX 78229, USA.'}, {'ForeName': 'Anabell', 'Initials': 'A', 'LastName': 'Lorenzo-Quintero', 'Affiliation': 'Arizona State University, College of Health Solutions, 550 North 3rd Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Leopoldo', 'Initials': 'L', 'LastName': 'Hartmann Manrique', 'Affiliation': 'Arizona State University, College of Health Solutions, 550 North 3rd Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Noe C', 'Initials': 'NC', 'LastName': 'Crespo', 'Affiliation': 'San Diego State University, School of Public Health, 5500 Campanile Drive, San Diego, CA 92182, USA. Electronic address: ncrespo@sdsu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105956']
625,31021880,Effect of pre-operative oral carbohydrate loading on recovery after day-case cholecystectomy: A randomised controlled trial.,"BACKGROUND


Pre-operative carbohydrate loading has been shown to reduce pre-operative discomfort and postoperative nausea and vomiting in general surgical patients. Few studies have considered day-case surgery.
OBJECTIVE


The aim of this prospective randomised study was to determine whether pre-operative carbohydrate loading enhanced recovery after day-case cholecystectomy.
DESIGN


A randomised controlled trial.
SETTING


Secondary care in a district general and a university hospital in Finland between 2013 and 2016.
PATIENTS


A total of 113 patients American Society of Anesthesiologists physical status I or II aged 18 to 70 undergoing day-case cholecystectomy were included in the study. Exclusion criteria were bleeding or coagulation disorders, BMI more than 40 kg m, dementia, insulin-treated diabetes, migraine, Meniere's disease or a history of alcohol or drug abuse.
INTERVENTION


The carbohydrate-rich drink group received oral carbohydrate (200 ml) 2 to 3 h before surgery, and the control (fasting) group fasted from midnight according to standard protocol.
MAIN OUTCOME MEASURES


Visual analogue scales (VAS) were used to score six forms of discomfort: the need for analgesia and antiemetics, the time to drinking, eating and first mobilisation after surgery and the time to discharge. Any hospital re-admission was also recorded.
RESULTS


The highest VAS scores were seen for mouth dryness and tiredness 2 h after surgery in the fasting group. There were no significant differences in any VAS scores between the study groups. No differences in time to mobilisation, need for pain or antiemetic medication or time to discharge were seen between the groups.
CONCLUSION


Compared with overnight fasting, pre-operative carbohydrate loading did not significantly enhance peri-operative well being or recovery in patients undergoing day-case cholecystectomy.
TRIAL REGISTRATION


Clinicaltrials.gov Identifier: NCT03757208.",2019,"No differences in time to mobilisation, need for pain or antiemetic medication or time to discharge were seen between the groups.
","['113 patients American Society of Anesthesiologists physical status I or II aged 18 to 70 undergoing day-case cholecystectomy were included in the study', 'recovery after day-case cholecystectomy', ""Exclusion criteria were bleeding or coagulation disorders, BMI more than 40\u200akg\u200am, dementia, insulin-treated diabetes, migraine, Meniere's disease or a history of alcohol or drug abuse"", 'general surgical patients', 'Secondary care in a district general and a university hospital in Finland between 2013 and 2016']","['pre-operative oral carbohydrate loading', 'carbohydrate-rich drink group received oral carbohydrate (200\u200aml) 2 to 3\u200ah before surgery, and the control (fasting) group fasted from midnight according to standard protocol']","['VAS scores', 'time to mobilisation, need for pain or antiemetic medication or time to discharge', 'Visual analogue scales (VAS) were used to score six forms of discomfort: the need for analgesia and antiemetics, the time to drinking, eating and first mobilisation after surgery and the time to discharge', 'highest VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0005779', 'cui_str': 'Blood Coagulation Disorders'}, {'cui': 'C1532718', 'cui_str': 'kg-m'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0025281', 'cui_str': ""Meniere's Syndrome""}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0013146', 'cui_str': 'Drug abuse (disorder)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0016132', 'cui_str': 'Finland'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4277655', 'cui_str': 'Diet, Carbohydrate Loading'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0041119', 'cui_str': 'Hydrogen-3'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0332172', 'cui_str': 'Midnight (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0185112', 'cui_str': 'Mobilizing (regime/therapy)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",113.0,0.150738,"No differences in time to mobilisation, need for pain or antiemetic medication or time to discharge were seen between the groups.
","[{'ForeName': 'Heli', 'Initials': 'H', 'LastName': 'Helminen', 'Affiliation': 'From the Department of Surgery and Anaesthesia, Seinäjoki Central Hospital, Seinäjoki (HH, HB, PO, JS) and Department of Surgery and Biostatistics, Oulu University Hospital, Oulu, Finland (HH, HB, PO, JS).'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Branders', 'Affiliation': ''}, {'ForeName': 'Pasi', 'Initials': 'P', 'LastName': 'Ohtonen', 'Affiliation': ''}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Saarnio', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001002']
626,31261168,Complex effects of continuous vasopressor infusion on fluid responsiveness during liver resection: A randomised controlled trial.,"BACKGROUND


Fluid responsiveness is an important factor to consider for fluid volume loading during major surgery. The effect of continuous vasopressor infusion on fluid responsiveness during prolonged major surgery is a concern.
OBJECTIVE


We hypothesised that continuous vasopressor infusion during major surgery might not exert significant effects on changes in stroke volume variation (SVV) following fluid bolus infusion, and thereby on fluid responsiveness.
DESIGN


Randomised controlled trial.
SETTING


University hospital from April 2014 to August 2016.
PATIENTS


Patients undergoing liver resection who were randomised to receive continuous intravenous infusion of phenylephrine (P group), norepinephrine (N group), or no vasopressor (C group) (n=17/group). Exclusion criteria were cardiac arrhythmia and severe cardiac, pulmonary or renal dysfunction.
INTERVENTION


Patients received 4 ml kg fluid boluses of 6% hydroxyethyl starch solution when SVV was at least 12%. Vasopressors were administered continuously to maintain the systemic vascular resistance index at more than 1900 dyn s cm m.
MAIN OUTCOME MEASURES


Cardiac index and SVV were measured using the FloTrac/Vigileo system (Version 4.00). The number of fluid boluses with fluid responsiveness (i.e. >15% increase in cardiac index) was compared between groups using multilevel logistic regression analysis.
RESULTS


Numbers of fluid responsive boluses in the C, P and N groups were 12 (14%), 22 (34%) and 19 (27%), respectively. Odds ratios on fluid responsiveness for phenylephrine and norepinephrine compared with the control were 3.65 (97.5% confidence interval, 1.15 to 11.6; P = 0.012) and 2.56 (97.5% confidence interval, 0.82 to 8.00; P = 0.064), respectively. Decreases in SVV after fluid bolus infusion for the P and N groups were comparable with the C group (P = 0.23 and 0.53, respectively).
CONCLUSION


Continuous administration of phenylephrine increased fluid responsiveness during liver resection, suggesting complex effects of continuous vasopressor infusion involving changes in cardiac preload and afterload.
TRIAL REGISTRATION


UMIN000011024.",2019,"Decreases in SVV after fluid bolus infusion for the P and N groups were comparable with the C group (P = 0.23 and 0.53, respectively).
","['University hospital from April 2014 to August 2016', 'Patients undergoing liver resection', 'liver resection']","['continuous vasopressor infusion', 'phenylephrine', 'phenylephrine (P group), norepinephrine (N group), or no vasopressor (C group) (n=17/group', '4\u200aml\u200akg fluid boluses of 6% hydroxyethyl starch solution', 'phenylephrine and norepinephrine']","['stroke volume variation (SVV', 'number of fluid boluses with fluid responsiveness', 'cardiac index', 'SVV', 'systemic vascular resistance index', 'Odds ratios on fluid responsiveness', 'Cardiac index and SVV', 'cardiac arrhythmia and severe cardiac, pulmonary or renal dysfunction', 'fluid responsiveness']","[{'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0020352', 'cui_str': 'hydroxyethylstarch'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C4518814', 'cui_str': 'Stroke volume variation'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index (observable entity)'}, {'cui': 'C0456260', 'cui_str': 'Systemic vascular resistance index (observable entity)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C1869051', 'cui_str': 'Cardiac arrhythmias (SMQ)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}]",,0.56142,"Decreases in SVV after fluid bolus infusion for the P and N groups were comparable with the C group (P = 0.23 and 0.53, respectively).
","[{'ForeName': 'Shiroh', 'Initials': 'S', 'LastName': 'Nakamoto', 'Affiliation': 'From the Department of Anaesthesiology and Pain Medicine, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan (SN, TT, TO, MH).'}, {'ForeName': 'Tsuneo', 'Initials': 'T', 'LastName': 'Tatara', 'Affiliation': ''}, {'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Okamoto', 'Affiliation': ''}, {'ForeName': 'Munetaka', 'Initials': 'M', 'LastName': 'Hirose', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001046']
627,31375874,Effects of milk powder intervention on bone mineral density and indicators related to bone metabolism in Chinese adolescents.,"The study is to determine the effects of milk powder on bone density and metabolism in healthy adolescents. Vitamin D and calcium supplements increased IGF-1 but did not affect bone mineralization or turnover. Higher vitamin D in combination with sufficient calcium supplementation in such populations requires attention.
INTRODUCTION


Both calcium and vitamin D play an important role in bone mineralization in adolescents.
METHODS


In this one and a half-year randomized controlled trial, 232 participants (aged 12-15 years) were randomly assigned to three intervention groups receiving milk powder fortified with vitamin D 400 IU plus calcium 300, or 600, or 900 mg [Ca3D (n = 54), Ca6D (n = 56), and Ca9D (n = 49)], or one control group maintaining habitual diet [control (n = 73)]. Bone turnover markers, serum intact PTH, 25(OH)D, and IGF-1 levels were measured at baseline and one and a half years, and bone mineral contents and bone areal mineral density were measured by Dual-energy X-ray absorptiometry (DXA) at baseline, one year, and one and a half years.
RESULTS


Baseline average serum 25(OH)D level and calcium intake were 29.4 nmol/L and 363.5 mg/day, respectively. There was a significant increase in bone turnover, total body, hip, lumbar spine bone mineral density (BMD), and total body BMC as well as slight fluctuations in 25(OH)D levels over one and a half years without between-group differences. Significantly decreased serum PTH level was only observed in the Ca6D group (31%, p < 0.0001), in which the intervention effect was also significant (p = 0.0029) compared with the control group. IGF-1 levels increased significantly in all intervention groups (18.5 to 22.8%, p < 0.05) but decreased in the control group (16.5%, p < 0.05), and the group by time interaction was also significant (p = 0.0029).
CONCLUSIONS


Our study showed that in healthy adolescents with low vitamin D status and calcium intake, mild vitamin D and mild to modest calcium supplements increased IGF-1 but did not affect bone mineralization or turnover. Higher vitamin D in combination with sufficient calcium supplementation in such populations requires attention.",2019,"IGF-1 levels increased significantly in all intervention groups (18.5 to 22.8%, p < 0.05) but decreased in the control group (16.5%, p < 0.05), and the group by time interaction was also significant (p = 0.0029).
","['healthy adolescents', 'adolescents', '232 participants (aged 12-15\xa0years', 'Chinese adolescents']","['calcium and vitamin D', 'milk powder intervention', 'control group maintaining habitual diet [control', 'Vitamin D and calcium supplements', 'milk powder', 'milk powder fortified with vitamin D 400\xa0IU plus calcium 300, or 600, or 900\xa0mg [Ca3D']","['Bone turnover markers, serum intact PTH, 25(OH)D, and IGF-1 levels', 'serum PTH level', 'serum 25(OH)D level and calcium intake', 'IGF-1', 'bone turnover, total body, hip, lumbar spine bone mineral density (BMD), and total body BMC as well as slight fluctuations in 25(OH)D levels', 'bone density and metabolism', 'bone mineralization or turnover', 'IGF-1 levels', 'bone mineral contents and bone areal mineral density', 'bone mineral density and indicators related to bone metabolism']","[{'cui': 'C0686747', 'cui_str': 'Well adolescent (finding)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3540037', 'cui_str': 'Calcium supplement (substance)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4517900', 'cui_str': '900 (qualifier value)'}]","[{'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0489458', 'cui_str': 'Calcium intake (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C2937276', 'cui_str': 'Slight (qualifier value)'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C2350989', 'cui_str': 'Bone Mineralization'}, {'cui': 'C0443331', 'cui_str': 'Turnover technique (qualifier value)'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",232.0,0.0742661,"IGF-1 levels increased significantly in all intervention groups (18.5 to 22.8%, p < 0.05) but decreased in the control group (16.5%, p < 0.05), and the group by time interaction was also significant (p = 0.0029).
","[{'ForeName': 'J X', 'Initials': 'JX', 'LastName': 'Lu', 'Affiliation': 'National Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention, 29 Nan Wei Road, Xi Cheng District, Beijing, 100050, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': 'National Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention, 29 Nan Wei Road, Xi Cheng District, Beijing, 100050, China.'}, {'ForeName': 'X Q', 'Initials': 'XQ', 'LastName': 'Hu', 'Affiliation': 'National Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention, 29 Nan Wei Road, Xi Cheng District, Beijing, 100050, China.'}, {'ForeName': 'Z W', 'Initials': 'ZW', 'LastName': 'Huang', 'Affiliation': 'National Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention, 29 Nan Wei Road, Xi Cheng District, Beijing, 100050, China.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'National Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention, 29 Nan Wei Road, Xi Cheng District, Beijing, 100050, China. zhangqian7208@163.com.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-019-05105-4']
628,31392401,Study of twice-weekly injections of Teriparatide by comparing efficacy with once-weekly injections in osteoporosis patients: the TWICE study.,"A 48-week, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial (the TWICE study) conducted in Japanese primary osteoporosis patients with a high risk of fractures demonstrated that a 28.2-μg twice-weekly regimen of teriparatide can provide comparable efficacy to a 56.5-μg once-weekly regimen of teriparatide, while also improving safety.
INTRODUCTION


While a 56.5-μg once-weekly regimen of teriparatide has high efficacy for osteoporosis, treatment continuation rates are low, with one of the major causes being adverse drug reactions such as nausea or vomiting. The TWICE study was therefore conducted to investigate whether a twice-weekly regimen with 28.2-μg teriparatide can provide comparable efficacy to the 56.5-μg once-weekly regimen while improving safety.
METHODS


A 48-week, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial was conducted in Japan. Patients with primary osteoporosis aged ≥ 65 years at high risk of fractures (n = 553) were randomly allocated to the 28.2-μg twice-weekly group (n = 277) or the 56.5-μg once-weekly group (n = 276). The primary endpoint was the percentage change in lumbar spine (L2-L4) bone mineral density (BMD) at final follow-up.
RESULTS


The percentage changes in lumbar spine (L2-L4) BMD at final follow-up in the 28.2-μg twice-weekly and 56.5-μg once-weekly groups were 7.3% and 5.9%, respectively; the difference (95% confidence interval [CI]) in percentage change was 1.3% (0.400-2.283%). Since the lower limit of the 95% CI was above the pre-specified non-inferiority margin (- 1.6%), non-inferiority of the 28.2-μg twice-weekly group was demonstrated. Adverse drug reactions were significantly less frequent in the 28.2-μg twice-weekly group (39.7% vs 56.2%; p < 0.01); the incidence of major adverse drug reactions was lower, and the number of subjects who discontinued due to adverse drug reactions was less in the 28.2-μg twice-weekly group.
CONCLUSIONS


A 28.2-μg twice-weekly regimen of teriparatide can provide comparable efficacy to a 56.5-μg once-weekly regimen while improving safety.
CLINICAL TRIAL REGISTRATION


JapicCTI-163477 .",2019,"Adverse drug reactions were significantly less frequent in the 28.2-μg twice-weekly group (39.7% vs 56.2%; p < 0.01); the incidence of major adverse drug reactions was lower, and the number of subjects who discontinued due to adverse drug reactions was less in the 28.2-μg twice-weekly group.
","['Japanese primary osteoporosis patients with a high risk of fractures', 'Japan', 'Patients with primary osteoporosis aged ≥', 'osteoporosis', 'osteoporosis patients', '65\xa0years at high risk of fractures (n\u2009=\u2009553']","['teriparatide', 'Teriparatide']","['percentage change in lumbar spine (L2-L4) bone mineral density (BMD', 'safety', 'Adverse drug reactions', 'adverse drug reactions', 'nausea or vomiting', 'incidence of major adverse drug reactions', 'lumbar spine (L2-L4) BMD']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0410438', 'cui_str': 'Primary osteoporosis (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0070093', 'cui_str': 'Teriparatide'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",553.0,0.409506,"Adverse drug reactions were significantly less frequent in the 28.2-μg twice-weekly group (39.7% vs 56.2%; p < 0.01); the incidence of major adverse drug reactions was lower, and the number of subjects who discontinued due to adverse drug reactions was less in the 28.2-μg twice-weekly group.
","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Sugimoto', 'Affiliation': 'Internal Medicine 1, Shimane University Faculty of Medicine, 89-1 Ennya-cho, Izumo, Shimane, 693-8501, Japan. sugimoto@med.shimane-u.ac.jp.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Shiraki', 'Affiliation': 'Research Institute and Practice for Involutional Diseases, 1610-1 Misatomeisei, Azumino, Nagano, 399-8101, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fukunaga', 'Affiliation': 'Kawasaki Medical School, 577 Matsushima, Kurashiki, Okayama, 701-0192, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kishimoto', 'Affiliation': 'Nojima Hospital, 2714-1 Sesakimachi, Kurayoshi, Tottori, 682-0863, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hagino', 'Affiliation': 'School of Health Science, Tottori University, 86 Nishicho, Yonago, Tottori, 683-8503, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Sone', 'Affiliation': 'Department of Nuclear Medicine, Kawasaki Medical School, 577 Matsushima, Kurashiki, Okayama, 701-0192, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Nakano', 'Affiliation': 'Tamana Central Hospital, 1950 Naka, Tamana, Kumamoto, 865-0064, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ito', 'Affiliation': 'Center for Diversity and Inclusion, Nagasaki University, 1-7-1 Sakamoto, Nagasaki, Nagasaki, 852-8520, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Yoshikawa', 'Affiliation': 'Department of Orthopaedic Surgery, Graduated School of Medicine, Osaka University, 1-1 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Minamida', 'Affiliation': 'Asahi Kasei Pharma Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Tsuruya', 'Affiliation': 'Asahi Kasei Pharma Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Nakamura', 'Affiliation': 'Toto Sangenjaya Rehabilitation Hospital, 1-24-3 Sangenjaya, Setagaya-ku, Tokyo, 154-0024, Japan.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-019-05111-6']
629,31259655,A Dose-Response Study to Examine the Methodology for Demonstrating the Local Therapeutic Equivalence of the Fluticasone Propionate Component of an Orally Inhaled Combination Therapy of Fluticasone Propionate/Salmeterol Dry Powder.,"Background:  Asthma is widely treated using inhaled corticosteroid/long-acting beta-agonist combinations, such as fluticasone propionate/salmeterol (FPS) dry powder inhaler. Some regulators require generic medications to demonstrate local therapeutic equivalence (LTE) for each component of the FPS reference product. Fractional exhaled nitric oxide (F eNO ) was developed as a possible LTE endpoint for the fluticasone propionate (FP) component of FPS in a randomized, double-blind, crossover study in steroid-naive asthma patients with elevated F eNO  (≥45 parts per billion).  Methods:  Thirty-four patients received three of five treatments: FPS 100/50 μg once daily (QD), FPS 100/50 μg twice daily (BID), FPS 250/50 μg BID, FPS 500/50 μg BID, or placebo, each for 2 weeks separated by 14-day washout. F eNO  was measured on days 1, 2, 3, 5, 7, and 14 of each period, according to American Thoracic Society standards.  Results:  FPS treatments decreased F eNO  compared with placebo, with the largest differentiation between doses noted on day 14; the mean decreases from days 1 to 14 ranged from -46.6% to -64.5% with FPS versus -9.1% with placebo. The dose-response plateaued at 200 μg/day (FPS 100/50 μg BID). Linear regression analysis revealed significant slopes between FPS doses, with the steepest between 100/50 μg QD and 100/50 μg BID (-0.0039,  p  = 0.020). An estimated sample size (SS) of 160 or 48 patients would be required to demonstrate LTE of generic and FPS reference products (0.80-1.25 and 0.67-1.50 bioequivalence limits, respectively). However, as the slope between BID FPS doses was shallow, a larger SS may be needed if only an approved dose regimen was used.  Conclusion:  F eNO  could be a valid endpoint to determine LTE between the FP component of generic and reference FPS products, but only if QD dosing and wide equivalence limits are included. As QD dosing is not an approved regimen, this approach is unlikely to be acceptable.",2019,"FPS treatments decreased F eNO  compared with placebo, with the largest differentiation between doses noted on day 14; the mean decreases from days 1 to 14 ranged from -46.6% to -64.5% with FPS versus -9.1% with placebo.",['steroid-naive asthma patients with elevated F eNO'],"['placebo', 'Fluticasone Propionate/Salmeterol Dry Powder', 'fluticasone propionate/salmeterol (FPS) dry powder inhaler', 'FPS 100/50\u2009μg once daily (QD), FPS 100/50\u2009μg twice daily (BID), FPS 250/50\u2009μg BID, FPS 500/50\u2009μg BID, or placebo', 'Fluticasone Propionate Component', 'fluticasone propionate (FP) component of FPS']",['Fractional exhaled nitric oxide (F eNO '],"[{'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C0073992', 'cui_str': 'salmeterol'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C2723054', 'cui_str': 'salmeterol Dry Powder Inhaler [Serevent]'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0048106', 'cui_str': 'BIDS'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}]",,0.301104,"FPS treatments decreased F eNO  compared with placebo, with the largest differentiation between doses noted on day 14; the mean decreases from days 1 to 14 ranged from -46.6% to -64.5% with FPS versus -9.1% with placebo.","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Allan', 'Affiliation': 'Mylan Pharma UK Limited, Sandwich, United Kingdom.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Haughie', 'Affiliation': 'Mylan Pharma UK Limited, Sandwich, United Kingdom.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Kerwin', 'Affiliation': 'Clinical Research Institute of Southern Oregon, Medford, Oregon.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Ward', 'Affiliation': 'Mylan Pharma UK Limited, Sandwich, United Kingdom.'}]",Journal of aerosol medicine and pulmonary drug delivery,['10.1089/jamp.2018.1520']
630,31259673,A Dose-Response Study Examining the Use of Methacholine Challenge to Demonstrate Local Therapeutic Equivalence of the Salmeterol Component of Generic Inhaled Fluticasone Propionate/Salmeterol Combination Products.,"Background:  Asthma is widely treated using inhaled corticosteroid/long-acting beta agonist (LABA) combinations, for example, fluticasone propionate/salmeterol (FPS) dry powder inhaler, marketed as Advair ®  Diskus ® . Some regulators require generics to demonstrate local (lung) therapeutic equivalence (LTE) for each component of the FPS reference, ideally with a dose-response within the approved FPS dose range. We sought to develop a methacholine challenge (MeCh) LTE methodology for assessing the LABA (salmeterol) component of FPS.  Methods:  Forty-six patients with asthma received single doses of albuterol (active control; 90 or 180 μg), FPS (100/50 or 200/100 μg), and placebo on 5 separate study days. Spirometry and MeCh were performed 1, 6, and 10 hours after study drug inhalation. Primary endpoint was provocative concentration of methacholine producing a 20% fall in forced expiratory volume in 1 second (PC 20 ). Study entry required screening PC 20  ≤8 mg/mL, with a greater than fourfold increase (and PC 20  ≤128 mg/mL) after 180 μg albuterol.  Results:  Both albuterol (90 and 180 μg) and FPS (100/50 and 200/100 μg) significantly increased PC 20  compared with placebo (sustained 6 and 10 hours postdose with FPS but not albuterol). The dose-response slopes (95% confidence interval) estimated 1 hour after treatment were 0.374 (-0.068 to 0.815) and 0.310 (-0.135 to 0.754) between low and high doses of albuterol and FPS, respectively, both nonsignificant. Slopes were shallower than those available in the literature for albuterol and formoterol, but similar to those for salmeterol.  Conclusions:  These data confirm that the bronchoprotective effect of FPS lasts longer than that of albuterol. The shallow dose-response slope we observed for albuterol is contrary to previous reports, probably due to the measurement of PC 20  beginning at 1 hour postdose. The results suggest that use of MeCh to assess LTE for salmeterol formulations may be more difficult to accomplish than it is for albuterol and formoterol products.",2019,"The dose-response slopes (95% confidence interval) estimated 1 hour after treatment were 0.374 (-0.068 to 0.815) and 0.310 (-0.135 to 0.754) between low and high doses of albuterol and FPS, respectively, both nonsignificant.",['Forty-six patients with asthma received single doses of'],"['placebo', 'Inhaled Fluticasone Propionate/Salmeterol Combination Products', 'methacholine challenge (MeCh) LTE', 'inhaled corticosteroid/long-acting beta agonist (LABA) combinations, for example, fluticasone propionate/salmeterol', 'Salmeterol Component of Generic', 'albuterol (active control; 90 or 180\u2009μg), FPS']","['provocative concentration of methacholine producing a 20% fall in forced expiratory volume in 1 second (PC 20 ', 'dose-response slopes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C0073992', 'cui_str': 'salmeterol'}, {'cui': 'C0430567', 'cui_str': 'Methacholine challenge (procedure)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0600370', 'cui_str': 'Methacholine'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",46.0,0.20087,"The dose-response slopes (95% confidence interval) estimated 1 hour after treatment were 0.374 (-0.068 to 0.815) and 0.310 (-0.135 to 0.754) between low and high doses of albuterol and FPS, respectively, both nonsignificant.","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Allan', 'Affiliation': 'Mylan Pharma UK Limited, Sandwich, United Kingdom.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Haughie', 'Affiliation': 'Mylan Pharma UK Limited, Sandwich, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Ahrens', 'Affiliation': 'Roy J. and Lucille A. Carver College of Medicine, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Sachinkumar', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Roy J. and Lucille A. Carver College of Medicine, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Ward', 'Affiliation': 'Mylan Pharma UK Limited, Sandwich, United Kingdom.'}]",Journal of aerosol medicine and pulmonary drug delivery,['10.1089/jamp.2018.1519']
631,30985537,Efficacy of acupressure on quality of recovery after surgery: Randomised controlled trial.,"BACKGROUND


Acupressure therapy is associated with favourable efficacies on postoperative nausea, pain and sleep disturbance, although the quality of the evidence is generally low. No randomised clinical trial has yet assessed the effect of acupressure on postoperative quality of recovery (QoR).
OBJECTIVE


The objective was to study acupressure efficacy on patient-reported postoperative recovery.
DESIGN


We conducted a single centre, three-group, blind, randomised controlled, pragmatic trial assessing acupressure therapy on the PC6, LI4 and HT7 acupoints.
PATIENTS


Postoperative patients expected to stay in hospital at least 2 days after surgery.
INTERVENTIONS


In the acupressure group, pressure was applied for 6 min (2 min per acupoint), three times a day after surgery for a maximum of 2 postoperative days during the hospital stay. In the sham group, extremely light touch was applied to the acupoints. The third group did not receive any touch.
MAIN OUTCOME MEASURES


The primary outcome was the change in the QoR, using the QoR-15 questionnaire, between postoperative days 1 and 3. Key secondary outcomes included patients' satisfaction, postoperative nausea and vomiting, pain score and opioid (morphine equivalent) consumption. Assessors for the primary and secondary endpoints were blind to the group allocation.
RESULTS


Overall, 163 patients were randomised (acupressure n=55, sham n=53, no intervention n=55). The mean (SD) postoperative change in QoR-15 did not differ statistically (P = 0.27) between the acupressure, sham and no intervention groups: 15.2 (17.8), 14.2 (21.9), 9.2 (21.7), respectively. Patient satisfaction (on a 0 to 10 scale) was statistically different (P = 0.01) among these three groups: 9.1 (1.5), 8.4 (1.6) and 8.2 (2.2), respectively. Changes in pain score and morphine equivalent consumption were not significantly different between the groups.
CONCLUSION


Two days of postoperative acupressure therapy (up to six treatments) did not significantly improve patient QoR, postoperative nausea and vomiting, pain score or opioid consumption. Acupressure, however, was associated with improved patient satisfaction.
TRIAL REGISTRATION


ClinicalTrials.gov, identifier: NCT02762435.",2019,"Patient satisfaction (on a 0 to 10 scale) was statistically different (P = 0.01) among these three groups: 9.1 (1.5), 8.4 (1.6) and 8.2 (2.2), respectively.","['163 patients', 'Postoperative patients expected to stay in hospital at least 2 days after surgery']","['acupressure therapy', 'Acupressure', 'acupressure', 'Acupressure therapy', 'postoperative acupressure therapy']","['quality of recovery', 'postoperative nausea, pain and sleep disturbance', 'Patient satisfaction', 'mean (SD) postoperative change in QoR-15', 'postoperative quality of recovery (QoR', 'change in the QoR, using the QoR-15 questionnaire', 'pain score and morphine equivalent consumption', ""patients' satisfaction, postoperative nausea and vomiting, pain score and opioid (morphine equivalent) consumption"", 'patient QoR, postoperative nausea and vomiting, pain score or opioid consumption', 'patient satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0520904', 'cui_str': 'Postoperative Nausea'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]",163.0,0.540177,"Patient satisfaction (on a 0 to 10 scale) was statistically different (P = 0.01) among these three groups: 9.1 (1.5), 8.4 (1.6) and 8.2 (2.2), respectively.","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Noll', 'Affiliation': ""From the Department of Anesthesiology, Stony Brook Medicine, Brookhaven, New York, USA (EN, SS, JLR, MCM, CP, DS, XG, TJG, EB-G), Department of Anesthesiology and Intensive Care, Hôpitaux Universitaires de Strasbourg (EN), Institut de Chirurgie guidée par l'image, IHU Hôpitaux Universitaires de Strasbourg, Strasbourg, France (EN) and Department of Surgery, Stony Brook Medicine, Brookhaven, New York, USA (ADP).""}, {'ForeName': 'Shivam', 'Initials': 'S', 'LastName': 'Shodhan', 'Affiliation': ''}, {'ForeName': 'Jamie L', 'Initials': 'JL', 'LastName': 'Romeiser', 'Affiliation': ''}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Madariaga', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Page', 'Affiliation': ''}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Santangelo', 'Affiliation': ''}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'Aurora D', 'Initials': 'AD', 'LastName': 'Pryor', 'Affiliation': ''}, {'ForeName': 'Tong J', 'Initials': 'TJ', 'LastName': 'Gan', 'Affiliation': ''}, {'ForeName': 'Elliott', 'Initials': 'E', 'LastName': 'Bennett-Guerrero', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001001']
632,31274545,The impact of a transversus abdominis plane block including clonidine vs. intrathecal morphine on nausea and vomiting after caesarean section: A randomised controlled trial.,"BACKGROUND


Intrathecal morphine (ITM) is a widely used technique for postcaesarean section analgesia but entails a high risk of postoperative nausea and vomiting (PONV). The transversus abdominis plane (TAP) block is an alternative.
OBJECTIVE


We tested the hypothesis that a TAP block including clonidine reduces the incidence of PONV after caesarean section when compared with ITM.
DESIGN


A randomised, controlled, double-blinded study.
SETTING


Geneva University Hospitals, Switzerland, from October 2013 to February 2017.
PATIENTS


A total of 182 patients undergoing elective caesarean section were studied. Reasons for noninclusion were complicated pregnancy, contraindication to spinal anaesthesia or TAP block, extreme weight or height, allergy to any medication or previous median abdominal incision.
INTERVENTIONS


Patients were allocated randomly to one of two groups (quadruple blinded): 100 μg of morphine added to the spinal local anaesthetic or a bilateral TAP block with 20 ml of ropivacaine 0.375% + 75 μg of clonidine on each side.
MAIN OUTCOME MEASURES


The primary outcome measure was the total number of patients presenting with PONV at 24 h. Secondary aims were to compare other adverse effects (pruritus, respiratory depression, hypotension, bradycardia, sedation), analgesic efficacy and the quality of postoperative recovery.
RESULTS


At 24 h, there was no significant difference between ITM and TAP groups in the total number of patients presenting with PONV: 17/92 patients (18.5%, 95% confidence interval 11.1 to 27.9) and 27/88 patients (30.7%, 95% confidence interval 21.3 to 41.4) in TAP and ITM groups, respectively (P = 0.065). Pain scores at 6 h and cumulative morphine consumption at 24 h were lower in the ITM group (P < 0.0001 for morphine consumption at 24 h). The incidence of hypotension was higher in the TAP group (54.3 vs. 29.2%, P = 0.0006). Maternal satisfaction was high and not different between groups.
CONCLUSION


A TAP block with clonidine and local anaesthetic does not reduce significantly the incidence of PONV compared with ITM. We confirm the superiority of ITM on acute postcaesarean section analgesia compared with a TAP block, even with clonidine as an adjunct.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT01931215.",2019,Pain scores at 6 h and cumulative morphine consumption at 24 h were lower in the ITM group (P < 0.0001 for morphine consumption at 24 h).,"['after caesarean section', 'Geneva University Hospitals, Switzerland, from October 2013 to February 2017', '182 patients undergoing elective caesarean section were studied']","['clonidine', 'morphine (ITM', 'morphine added to the spinal local anaesthetic or a bilateral TAP block with 20\u200aml of ropivacaine 0.375%\u200a+\u200a75\u200aμg of clonidine', 'TAP', 'ITM', 'clonidine vs. intrathecal morphine']","['nausea and vomiting', 'adverse effects (pruritus, respiratory depression, hypotension, bradycardia, sedation), analgesic efficacy and the quality of postoperative recovery', 'incidence of PONV', 'Pain scores', 'Maternal satisfaction', 'cumulative morphine consumption', 'incidence of hypotension', 'total number of patients presenting with PONV']","[{'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0002934', 'cui_str': 'Conduction-Blocking Anesthetics'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C4517455', 'cui_str': '0.375 (qualifier value)'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0235063', 'cui_str': 'Respiratory Depression'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]",182.0,0.415489,Pain scores at 6 h and cumulative morphine consumption at 24 h were lower in the ITM group (P < 0.0001 for morphine consumption at 24 h).,"[{'ForeName': 'Domitille', 'Initials': 'D', 'LastName': 'Dereu', 'Affiliation': 'From the Department of Anaesthesia, Geneva University Hospitals, Geneva 14 (DD, GLS, SM, BR), Department of Anaesthesia, Jura Hospital, Delémont (YM) and Division of Clinical Epidemiology, University Hospitals of Geneva, Geneva 14, Switzerland (CH).'}, {'ForeName': 'Georges L', 'Initials': 'GL', 'LastName': 'Savoldelli', 'Affiliation': ''}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Mercier', 'Affiliation': ''}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Combescure', 'Affiliation': ''}, {'ForeName': 'Stanislas', 'Initials': 'S', 'LastName': 'Mathivon', 'Affiliation': ''}, {'ForeName': 'Benno', 'Initials': 'B', 'LastName': 'Rehberg', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001013']
633,31999376,A Pooled Analysis of Fall Incidence From Placebo-Controlled Trials of Denosumab.,"Recent studies suggest that the RANK/RANKL system impacts muscle function and/or mass. In the pivotal placebo-controlled fracture trial of the RANKL inhibitor denosumab in women with postmenopausal osteoporosis, treatment was associated with a lower incidence of non-fracture-related falls (p = 0.02). This ad hoc exploratory analysis pooled data from five placebo-controlled trials of denosumab to determine consistency across trials, if any, of the reduction of fall incidence. The analysis included trials in women with postmenopausal osteoporosis and low bone mass, men with osteoporosis, women receiving adjuvant aromatase inhibitors for breast cancer, and men receiving androgen deprivation therapy for prostate cancer. The analysis was stratified by trial, and only included data from the placebo-controlled period of each trial. A time-to-event analysis of first fall and exposure-adjusted subject incidence rates of falls were analyzed. Falls were reported and captured as adverse events. The analysis comprised 10,036 individuals; 5030 received denosumab 60 mg subcutaneously once every 6 months for 12 to 36 months and 5006 received placebo. Kaplan-Meier estimates showed an occurrence of falls in 6.5% of subjects in the placebo group compared with 5.2% of subjects in the denosumab group (hazard ratio = 0.79; 95% confidence interval 0.66-0.93; p = 0.0061). Heterogeneity in study designs did not permit overall assessment of association with fracture outcomes. In conclusion, denosumab may reduce the risk of falls in addition to its established fracture risk reduction by reducing bone resorption and increasing bone mass. These observations require further exploration and confirmation in studies with muscle function or falls as the primary outcome. © 2020 The Authors. Journal of Bone and Mineral Research published by American Society for Bone and Mineral Research..",2020,"Kaplan-Meier estimates showed an occurrence of falls in 6.5% of subjects in the placebo group compared with 5.2% of subjects in the denosumab group (hazard ratio [95% CI]: 0.79 [0.66, 0.93]; p = 0.0061).","['women with postmenopausal osteoporosis', 'women with postmenopausal osteoporosis and low bone mass, men with osteoporosis, women receiving adjuvant aromatase inhibitors for breast cancer, and men receiving androgen deprivation therapy for prostate cancer']","['Placebo', 'denosumab 60\u2009mg subcutaneously', 'denosumab', 'placebo', 'Denosumab']",['occurrence of falls'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0029458', 'cui_str': 'Postmenopausal Bone Loss'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}]","[{'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}]",,0.315949,"Kaplan-Meier estimates showed an occurrence of falls in 6.5% of subjects in the placebo group compared with 5.2% of subjects in the denosumab group (hazard ratio [95% CI]: 0.79 [0.66, 0.93]; p = 0.0061).","[{'ForeName': 'Pojchong', 'Initials': 'P', 'LastName': 'Chotiyarnwong', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'McCloskey', 'Affiliation': 'Academic Unit of Bone Metabolism, Department of Oncology and Metabolism, The Mellanby Centre for Bone Research, The Centre for Integrated Research in Musculoskeletal Ageing, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Eastell', 'Affiliation': 'Academic Unit of Bone Metabolism, Department of Oncology and Metabolism, The Mellanby Centre for Bone Research, The Centre for Integrated Research in Musculoskeletal Ageing, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'McClung', 'Affiliation': 'Oregon Osteoporosis Center, Portland, OR, USA.'}, {'ForeName': 'Evelien', 'Initials': 'E', 'LastName': 'Gielen', 'Affiliation': 'Center for Metabolic Bone Diseases, University Hospitals Leuven, and Department of Chronic Diseases, Metabolism, and Aging, (CHROMETA), KU Leuven, Leuven, Belgium.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gostage', 'Affiliation': 'Academic Unit of Bone Metabolism, Department of Oncology and Metabolism, The Mellanby Centre for Bone Research, The Centre for Integrated Research in Musculoskeletal Ageing, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'McDermott', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Arkadi', 'Initials': 'A', 'LastName': 'Chines', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Cummings', 'Affiliation': 'San Francisco Coordinating Center, California Pacific Medical Center (CPMC), Research Institute and the University of California, San Francisco, CA, USA.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3972']
634,31515553,"Associations of plasma, RBCs, and hair carbon and nitrogen isotope ratios with fish, meat, and sugar-sweetened beverage intake in a 12-wk inpatient feeding study.","BACKGROUND


Naturally occurring carbon and nitrogen stable isotope ratios [13C/12C (CIR) and 15N/14N (NIR)] are promising dietary biomarkers. As these candidate biomarkers have long tissue residence times, long-term feeding studies are needed for their evaluation.
OBJECTIVE


Our aim was to evaluate plasma, RBCs, and hair CIR and NIR as biomarkers of fish, meat, and sugar-sweetened beverage (SSB) intake in a 12-wk dietary intervention.
METHODS


Thirty-two men (aged 46.2 ± 10.5 y; BMI: 27.2 ± 4.0 kg/m2) underwent a 12-wk inpatient dietary intervention at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in Phoenix, Arizona. The effects of fish, meat, and SSB intake on CIR and NIR were evaluated using a balanced factorial design, with each intake factor at 2 levels (present/absent) in a common, background diet (50% carbohydrate, 30% fat, 20% protein). Fasting blood samples were taken biweekly from baseline, and hair samples were collected at baseline and postintervention. Data were analyzed using multivariable regression.
RESULTS


The postintervention CIR of plasma was elevated when diets included meat (β = 0.89, 95% CI: 0.73,1.05) and SSBs (β = 0.48, 95% CI: 0.32, 0.64). The postintervention NIR of plasma was elevated when diets included fish (β = 0.85, 95% CI: 0.64, 1.05) and meat (β = 0.61, 95% CI: 0.42, 0.8). Results were similar for RBCs and hair. Postintervention RBC CIR and NIR had strong associations with baseline, suggesting that turnover to the intervention diets was incomplete after 12 wk. Estimates of isotopic turnover rate further confirmed incomplete turnover of RBCs.
CONCLUSIONS


CIR was associated with meat and SSBs, and more strongly with meat. NIR was associated with fish and meat, and more strongly with fish. Overall, CIR and NIR discriminated between dietary fish and meat, and to a lesser extent SSBs, indicating their potential utility as biomarkers of intake in US diets. Approaches to make these biomarkers more specific are needed. This trial was registered at clinicaltrials.gov as NCT01237093.",2019,"The postintervention CIR of plasma was elevated when diets included meat (β = 0.89, 95% CI: 0.73,1.05) and SSBs (β = 0.48, 95% CI: 0.32, 0.64).",['Thirty-two men (aged 46.2\xa0±\xa010.5 y'],"['fish, meat, and SSB intake', '12-wk inpatient dietary intervention', 'Naturally occurring carbon and nitrogen stable isotope ratios [13C/12C (CIR) and 15N/14N (NIR']","['postintervention NIR of plasma', 'postintervention CIR of plasma', 'Fasting blood samples', 'plasma, RBCs, and hair carbon and nitrogen isotope ratios with fish, meat, and sugar-sweetened beverage intake', 'plasma, RBCs, and hair CIR and NIR as biomarkers of fish, meat, and sugar-sweetened beverage (SSB) intake']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517521', 'cui_str': '10.5'}]","[{'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0007009', 'cui_str': 'Carbon'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}, {'cui': 'C0302918', 'cui_str': 'Stable isotope'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0014792', 'cui_str': 'erythrocytes'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0007009', 'cui_str': 'Carbon'}, {'cui': 'C0028162', 'cui_str': 'Nitrogen isotope'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.0472025,"The postintervention CIR of plasma was elevated when diets included meat (β = 0.89, 95% CI: 0.73,1.05) and SSBs (β = 0.48, 95% CI: 0.32, 0.64).","[{'ForeName': 'Susanne B', 'Initials': 'SB', 'LastName': 'Votruba', 'Affiliation': 'Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases/NIH, Phoenix, AZ, USA.'}, {'ForeName': 'Pamela A', 'Initials': 'PA', 'LastName': 'Shaw', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Oh', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Colleen A', 'Initials': 'CA', 'LastName': 'Venti', 'Affiliation': 'Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases/NIH, Phoenix, AZ, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Bonfiglio', 'Affiliation': 'Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases/NIH, Phoenix, AZ, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Krakoff', 'Affiliation': 'Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases/NIH, Phoenix, AZ, USA.'}, {'ForeName': 'Diane M', 'Initials': 'DM', 'LastName': ""O'Brien"", 'Affiliation': 'Center for Alaska Native Health Research, Institute of Arctic Biology, Department of Biology and Wildlife, University of Alaska Fairbanks, Fairbanks, AK, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqz208']
635,32223756,The effect of induced optimism on the optimistic update bias.,"BACKGROUND


Individuals tend to have an optimism bias, processing desirable information more frequently than undesirable information. However, people who have been diagnosed with depression often have a more pessimistic view of the future. A recent study suggests that future expectations in individuals with dysphoria become more optimistic when asked to make optimistic future predictions about the future. In the present study, we investigated the differential effects of induced optimism training which making optimistic future prediction to change future beliefs in normal participants with various levels of dysphoria (low, mild, high).
METHODS


We recruited normal participants (n = 69) from a local university students and divided participants into three groups (low, mild, high dysphoria) by measuring dysphoric mood. These three groups were assigned to the induced optimism training or control condition. After the training, participants performed the two-stage belief updating task. In the first stage, participants estimated their personal probability of experiencing adverse events while being presented with the average probability of the event occurring to a living person. This information could be desirable for participants(when presented with a probability that was below their estimation) or undesirable (when presented with a probability that was above their estimation). To assess how desirable versus undesirable information influenced beliefs, participants estimated their personal probability of experiencing the events again in the second stage. The amount of update error was calculated as the difference between the estimates in the first stage and the second stage. The difference between the errors was classified as the update bias.
RESULTS


After the induced optimism training, individuals with the mild dysphoria demonstrated a higher update bias than low (p < .001) and the high dysphoria (p < .05) group in induced optimism condition. Significant differences were not found in control group. Results indicates that individuals in the mild dysphoria group showed an increased update bias after being exposed to the induced optimism training Dysphoric mood and trait optimism remained unchanged in both the experimental and control groups.
CONCLUSIONS


Results suggest that induced optimism training has potential to change individuals with mild dysphoria perceptions' about the future.",2020,"Results indicates that individuals in the mild dysphoria group showed an increased update bias after being exposed to the induced optimism training Dysphoric mood and trait optimism remained unchanged in both the experimental and control groups.
","['individuals with dysphoria', 'normal participants with various levels of dysphoria (low, mild, high', 'normal participants (n\u2009=\u200969) from a local university students and divided participants into three groups (low, mild, high dysphoria) by measuring dysphoric mood']","['induced optimism training', 'optimism training', 'induced optimism training or control condition']","['optimism training Dysphoric mood and trait optimism', 'high dysphoria', 'personal probability of experiencing adverse events']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0233477', 'cui_str': 'Dysphoric mood (finding)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]","[{'cui': 'C0237428', 'cui_str': 'Optimism'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0237428', 'cui_str': 'Optimism'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0233477', 'cui_str': 'Dysphoric mood (finding)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0404144,"Results indicates that individuals in the mild dysphoria group showed an increased update bias after being exposed to the induced optimism training Dysphoric mood and trait optimism remained unchanged in both the experimental and control groups.
","[{'ForeName': 'Shinpei', 'Initials': 'S', 'LastName': 'Yoshimura', 'Affiliation': 'Department of Psychology, Otemon Gakuin University, 2-1-15, Nishi-ai, Osaka, Ibaraki, Japan. s-yoshimura@otemon.ac.jp.'}, {'ForeName': 'Yuma', 'Initials': 'Y', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Psychology, Otemon Gakuin University, 2-1-15, Nishi-ai, Osaka, Ibaraki, Japan.'}]",BMC psychology,['10.1186/s40359-020-0389-6']
636,32006006,Live-Attenuated Respiratory Syncytial Virus Vaccine With M2-2 Deletion and With Small Hydrophobic Noncoding Region Is Highly Immunogenic in Children.,"BACKGROUND


Respiratory syncytial virus (RSV) is the leading viral cause of severe pediatric respiratory illness, and vaccines are needed. Live RSV vaccine D46/NS2/N/ΔM2-2-HindIII, attenuated by deletion of the RSV RNA regulatory protein M2-2, is based on previous candidate LID/ΔM2-2 but incorporates prominent differences from MEDI/ΔM2-2, which was more restricted in replication in phase 1.
METHODS


RSV-seronegative children aged 6-24 months received 1 intranasal dose (105 plaque-forming units [PFUs] of D46/NS2/N/ΔM2-2-HindIII [n = 21] or placebo [n = 11]) and were monitored for vaccine shedding, reactogenicity, RSV-antibody responses and RSV-associated medically attended acute respiratory illness (RSV-MAARI) and antibody responses during the following RSV season.
RESULTS


All 21 vaccinees were infected with vaccine; 20 (95%) shed vaccine (median peak titer, 3.5 log10 PFUs/mL with immunoplaque assay and 6.1 log10 copies/mL with polymerase chain reaction). Serum RSV-neutralizing antibodies and anti-RSV fusion immunoglobulin G increased ≥4-fold in 95% and 100% of vaccines, respectively. Mild upper respiratory tract symptoms and/or fever occurred in vaccinees (76%) and placebo recipients (18%). Over the RSV season, RSV-MAARI occurred in 2 vaccinees and 4 placebo recipients. Three vaccinees had ≥4-fold increases in serum RSV-neutralizing antibody titers after the RSV season without RSV-MAARI.
CONCLUSIONS


D46/NS2/N/ΔM2-2-HindIII had excellent infectivity and immunogenicity and primed vaccine recipients for anamnestic responses, encouraging further evaluation of this attenuation strategy.
CLINICAL TRIALS REGISTRATION


NCT03102034 and NCT03099291.",2020,Mild upper respiratory symptoms and/or fever occurred in vaccinees (76%) and placebo recipients (18%).,"['children', 'RSV-seronegative children ages 6-24 months received one']","['vaccine', 'placebo', 'intranasal dose [105 plaque forming units (PFU)] of D46/NS2/N/ΔM2-2-HindIII (n=21) or placebo (n=11) (NCT03102034/NCT03099291']","['Mild upper respiratory symptoms and/or fever', 'vaccine shedding, reactogenicity, RSV-antibody responses and RSV-associated medically-attended acute respiratory illness (RSV-MAARI) and antibody responses', 'Serum RSV-neutralizing antibodies and anti-RSV F IgG', 'RSV season, RSV-MAARI', 'serum RSV-neutralizing antibody titers']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C0521144', 'cui_str': 'Seronegative (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0749874', 'cui_str': 'Upper respiratory symptom'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0475208', 'cui_str': 'TITR'}]",,0.193906,Mild upper respiratory symptoms and/or fever occurred in vaccinees (76%) and placebo recipients (18%).,"[{'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'McFarland', 'Affiliation': ""Department of Pediatrics, University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, Colorado, USA.""}, {'ForeName': 'Ruth A', 'Initials': 'RA', 'LastName': 'Karron', 'Affiliation': 'Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Petronella', 'Initials': 'P', 'LastName': 'Muresan', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health/Frontier Science Foundation, Boston, Massachusetts, USA.'}, {'ForeName': 'Coleen K', 'Initials': 'CK', 'LastName': 'Cunningham', 'Affiliation': 'Department of Pediatrics, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Perlowski', 'Affiliation': 'FHI 360, Durham, North Carolina, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Libous', 'Affiliation': 'FHI 360, Durham, North Carolina, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Oliva', 'Affiliation': 'Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Jean-Philippe', 'Affiliation': 'Maternal, Adolescent and Pediatric Research Branch, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Moye', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Schappell', 'Affiliation': 'Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Barr', 'Affiliation': ""Department of Pediatrics, University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, Colorado, USA.""}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Rexroad', 'Affiliation': 'Investigational Drug Service Pharmacy, Johns Hopkins Hospital, Baltimore, Maryland, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Fearn', 'Affiliation': ""Department of Pediatrics, Northwestern University Medical School and Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, USA.""}, {'ForeName': 'Mikhaela', 'Initials': 'M', 'LastName': 'Cielo', 'Affiliation': 'Division of Infectious Diseases, Maternal Child & Adolescent Center, University of Southern California Keck School of Medicine, Los Angeles, California, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wiznia', 'Affiliation': 'Department of Pediatrics, Albert Einstein College of Medicine and Jacobi Medical Center, Bronx, New York, USA.'}, {'ForeName': 'Jaime G', 'Initials': 'JG', 'LastName': 'Deville', 'Affiliation': 'David Geffen School of Medicine at University of California Los Angeles, California, USA.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Luongo', 'Affiliation': 'Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Collins', 'Affiliation': 'Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Ursula J', 'Initials': 'UJ', 'LastName': 'Buchholz', 'Affiliation': 'Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa049']
637,32242333,[Exploratory analysis of the influence of cognitive reserve on the benefits of cognitive stimulation therapy in patients with sporadic late-onset Alzheimer's disease].,"INTRODUCTION


The main objective of cognitive stimulation therapies is to promote the plasticity and learning ability that the individual is still in possession of in old age and to delay the clinical manifestations of neurodegenerative processes such as Alzheimer-type dementia. There are variables that can mediate the benefits of the intervention, such as the cognitive reserve.
AIM


To determine whether there is an interaction between the level of reserve and cognitive stimulation, and if it influences the cognitive performance of subjects with Alzheimer-type dementia.
PATIENTS AND METHODS


Twenty subjects (age: 66-89) with Alzheimer-type dementia who attend a day centre participated in the study. A pretest-posttest controlled design was used. The pilot group took part in the intervention for six months. Patients were classified into two levels of cognitive reserve (high and low) and then a broad neuropsychological battery was applied to perform a comprehensive analysis of cognition. Pre- and post-intervention differences were analysed through a two-factor ANOVA, one with repeated measures (pre- and post-intervention scores) and another with independent measures (level of cognitive reserve).
RESULTS


Interaction was found in the scores on the picture arrangement subtests (WAIS-III), failure to maintain the category and the percentage of errors in the Wisconsin Card Sorting Test.
CONCLUSIONS


The positive effect of the interaction on the executive function has been observed, specifically in the capacities for planning and sequencing, perceptual organisation, response inhibition, logical reasoning and mental flexibility.",2020,"RESULTS


Interaction was found in the scores on the picture arrangement subtests (WAIS-III), failure to maintain the category and the percentage of errors in the Wisconsin Card Sorting Test.
","['Twenty subjects (age: 66-89) with Alzheimer-type dementia who attend a day centre participated in the study', 'subjects with Alzheimer-type dementia', ""patients with sporadic late-onset Alzheimer's disease""]","['cognitive stimulation therapy', 'cognitive stimulation therapies']",[],"[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205422', 'cui_str': 'Sporadic'}, {'cui': 'C0494463', 'cui_str': 'Primary degenerative dementia of the Alzheimer type, senile onset'}]","[{'cui': 'C0150174', 'cui_str': 'Cognitive stimulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.028832,"RESULTS


Interaction was found in the scores on the picture arrangement subtests (WAIS-III), failure to maintain the category and the percentage of errors in the Wisconsin Card Sorting Test.
","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'López', 'Affiliation': 'Universidad de Salamanca, 37005 Salamanca, España.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Sánchez', 'Affiliation': 'Universidad de Salamanca, 37005 Salamanca, España.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Martín', 'Affiliation': 'Universidad de Salamanca, 37005 Salamanca, España.'}]",Revista de neurologia,['10.33588/rn.7008.2019420']
638,32208439,Effect of four classes of antihypertensive drugs on cardiac repolarization heterogeneity: A double-blind rotational study.,"BACKGROUND


T-wave area dispersion (TW-Ad) is a novel electrocardiographic (ECG) repolarization marker associated with sudden cardiac death. However, limited data is available on the clinical correlates of TW-Ad. In addition, there are no previous studies on cardiovascular drug effects on TW-Ad. In this study, we examined the relation between TW-Ad and left ventricular mass. We also studied the effects of four commonly used antihypertensive drugs on TW-Ad.
METHODS


A total of 242 moderately hypertensive males (age, 51±6 years; office systolic/diastolic blood pressure during placebo, 153±14/100±8 mmHg), participating in the GENRES study, were included. Left ventricular mass index was determined by transthoracic echocardiography. Antihypertensive four-week monotherapies (a diuretic, a beta-blocker, a calcium channel blocker, and an angiotensin receptor antagonist) were administered in a randomized rotational fashion. Four-week placebo periods preceded all monotherapies. The average value of measurements (over 1700 ECGs in total) from all available placebo periods served as a reference to which measurements during each drug period were compared.
RESULTS


Lower, i.e. risk-associated TW-Ad values correlated with a higher left ventricular mass index (r = -0.14, p = 0.03). Bisoprolol, a beta-blocker, elicited a positive change in TW-Ad (p = 1.9×10-5), but the three other drugs had no significant effect on TW-Ad.
CONCLUSIONS


Our results show that TW-Ad is correlated with left ventricular mass and can be modified favorably by the use of bisoprolol, although demonstration of any effects on clinical endpoints requires long-term prospective studies. Altogether, our results suggest that TW-Ad is an ECG repolarization measure of left ventricular arrhythmogenic substrate.",2020,"Bisoprolol, a beta-blocker, elicited a positive change in TW-Ad (p = 1.9×10-5), but the three other drugs had no significant effect on TW-Ad","['A total of 242 moderately hypertensive males (age, 51±6 years; office systolic/diastolic blood pressure during placebo, 153±14/100±8 mmHg), participating in the GENRES study, were included']","['antihypertensive drugs', 'placebo', 'Antihypertensive four-week monotherapies (a diuretic, a beta-blocker, a calcium channel blocker, and an angiotensin receptor antagonist']","['cardiac repolarization heterogeneity', 'ECG repolarization measure of left ventricular arrhythmogenic substrate', 'TW-Ad', 'Left ventricular mass index']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0006684', 'cui_str': 'Calcium Channel Blocking Drugs'}, {'cui': 'C0815017', 'cui_str': 'Angiotensin Receptor Blockers'}]","[{'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",242.0,0.136879,"Bisoprolol, a beta-blocker, elicited a positive change in TW-Ad (p = 1.9×10-5), but the three other drugs had no significant effect on TW-Ad","[{'ForeName': 'Heini', 'Initials': 'H', 'LastName': 'Sánez Tähtisalo', 'Affiliation': 'Department of Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Timo P', 'Initials': 'TP', 'LastName': 'Hiltunen', 'Affiliation': 'Department of Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Tuomas', 'Initials': 'T', 'LastName': 'Kenttä', 'Affiliation': 'Research Unit of Internal Medicine, Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland.'}, {'ForeName': 'Juhani', 'Initials': 'J', 'LastName': 'Junttila', 'Affiliation': 'Research Unit of Internal Medicine, Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland.'}, {'ForeName': 'Lasse', 'Initials': 'L', 'LastName': 'Oikarinen', 'Affiliation': 'Division of Cardiology, Heart and Lung Center, University of Helsinki and Helsinki University Central Hospital, Helsinki, Finland.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Virolainen', 'Affiliation': 'Division of Cardiology, Heart and Lung Center, University of Helsinki and Helsinki University Central Hospital, Helsinki, Finland.'}, {'ForeName': 'Kimmo K', 'Initials': 'KK', 'LastName': 'Kontula', 'Affiliation': 'Department of Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Porthan', 'Affiliation': 'Division of Cardiology, Heart and Lung Center, University of Helsinki and Helsinki University Central Hospital, Helsinki, Finland.'}]",PloS one,['10.1371/journal.pone.0230655']
639,32208443,"Differences in the performance of resuscitation according to the resuscitation guideline terminology during infant cardiopulmonary resuscitation: ""Approximately 4 cm"" versus ""at least one-third the anterior-posterior diameter of the chest"".","AIM


This study was conducted to investigate the effect of resuscitation guideline terminology on the performance of infant cardiopulmonary resuscitation (CPR).
METHODS


A total of 40 intern or resident physicians conducted 2-min CPR with the two-finger technique (TFT) and two-thumb technique (TT) on a simulated infant cardiac arrest model with a 1-day interval. They were randomly assigned to Group A or B. The participants of Group A conducted CPR with the chest compression depth (CCD) target of ""approximately 4 cm"" and those of Group B conducted CPR with the CCD target of ""at least one-third the anterior-posterior diameter of the chest"". Single rescuer CPR was performed with a 15:2 compression to ventilation ratio on the floor.
RESULTS


In both chest compression techniques, the average CCD of Group B was significantly deeper than that of Group A (TFT: 41.0 [range, 39.3-42.0] mm vs. 36.5 [34.0-37.9] mm, P = 0.002; TT: 42.0 [42.0-43.0] mm vs. 37.0 [35.3-38.0] mm, P < 0.001). Adequacy of CCD also showed similar results (Group B vs. A; TFT: 99% [82-100%] vs. 29% [12-58%], P = 0.001; TT: 100% [100-100%] vs. 28% [8-53%], P < 0.001).
CONCLUSIONS


Using the CCD target of ""at least one-third the anterior-posterior diameter of the chest"" resulted in deep and adequate chest compressions during simulated infant CPR in contrast to the CCD target of ""approximately 4 cm"". Therefore, changes in the terminology used in the guidelines should be considered to improve the quality of CPR.
TRIAL REGISTRATION


Clinical Research Information Service; cris.nih.go.kr/cris/en (Registration number: KCT0003486).",2020,"In both chest compression techniques, the average CCD of Group B was significantly deeper than that of Group A (TFT: 41.0 [range, 39.3-42.0] mm vs. 36.5 [34.0-37.9] mm, P = 0.002; TT: 42.0 [42.0-43.0] mm vs. 37.0 [35.3-38.0] mm, P < 0.001).",[],"['resuscitation guideline terminology', 'TFT', '40 intern or resident physicians conducted 2-min CPR with the two-finger technique (TFT) and two-thumb technique (TT']",[],[],"[{'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0028275', 'cui_str': 'Terminology'}, {'cui': 'C0040130', 'cui_str': 'Thyroid Gland Function Tests'}, {'cui': 'C1320928', 'cui_str': 'Resident physician (occupation)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0016129', 'cui_str': 'Fingers'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0040067', 'cui_str': 'Thumb'}]",[],,0.0590075,"In both chest compression techniques, the average CCD of Group B was significantly deeper than that of Group A (TFT: 41.0 [range, 39.3-42.0] mm vs. 36.5 [34.0-37.9] mm, P = 0.002; TT: 42.0 [42.0-43.0] mm vs. 37.0 [35.3-38.0] mm, P < 0.001).","[{'ForeName': 'Wongyu', 'Initials': 'W', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Dongjun', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Department of Emergency Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Je Hyeok', 'Initials': 'JH', 'LastName': 'Oh', 'Affiliation': 'Department of Emergency Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea.'}]",PloS one,['10.1371/journal.pone.0230687']
640,32241751,Effects of an extrinsic motivator on the evaluation of cognitive and daily living functions in patients with schizophrenia.,"We investigated the effect of an extrinsic motivator on the MATRICS Consensus Cognitive Battery (MCCB) and UCSD Performance-Based Skills Assessment (UPSA) scores, which assess cognitive and daily living functions, in patients with schizophrenia. We enrolled 60 clinically stable patients with schizophrenia and allocated them to the motivator or control group. We conducted baseline assessments of cognitive function using the MCCB, daily living function using the UPSA, clinical symptoms, and psychosocial characteristics in both groups. In the retrial, we initially evaluated clinical symptoms. Next, we assigned an extrinsic motivator to the motivator group and again assessed cognitive function and daily living function using the MCCB and UPSA. Statistical analyses were performed using t-tests, Chi-square tests, Fisher's exact test, repeated measures analysis of variance, and logistic regression analysis. We found significant time × group interactions in processing speed, verbal learning, visual learning, and composite scores of MCCB. There were no significant interactions in UPSA scores. The meaningful change rates of social cognition and composite scores in MCCB were significantly higher in the motivator group than in the control group. After adjusting for additional variables, the extrinsic motivator had a significant effect on the meaningful MCCB composite score change. Conclusively, our findings suggest beneficial effects of extrinsic motivator on the MCCB score in patients with schizophrenia. In the future, the implementation and interpretation of the MCCB considering the motivation is necessary.",2020,"We found significant time × group interactions in processing speed, verbal learning, visual learning, and composite scores of MCCB.","['enrolled 60 clinically stable patients with schizophrenia and allocated them to the motivator or control group', 'patients with schizophrenia']",['extrinsic motivator'],"['meaningful MCCB composite score change', 'processing speed, verbal learning, visual learning, and composite scores of MCCB', 'Consensus Cognitive Battery (MCCB) and UCSD Performance-Based Skills Assessment (UPSA) scores', 'evaluation of cognitive and daily living functions', 'UPSA scores', 'MCCB score', 'social cognition and composite scores in MCCB', 'cognitive function and daily living function']","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205101', 'cui_str': 'External'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0582587', 'cui_str': 'Visual learning'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",60.0,0.0185012,"We found significant time × group interactions in processing speed, verbal learning, visual learning, and composite scores of MCCB.","[{'ForeName': 'Sung-Jin', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Busan Paik Hospital, Inje University College of Medicine, Busan, Republic of Korea.'}, {'ForeName': 'Do-Un', 'Initials': 'DU', 'LastName': 'Jung', 'Affiliation': 'Department of Psychiatry, Busan Paik Hospital, Inje University College of Medicine, Busan, Republic of Korea. Electronic address: gabriel.jdu@gmail.com.'}, {'ForeName': 'Jung-Joon', 'Initials': 'JJ', 'LastName': 'Moon', 'Affiliation': 'Department of Psychiatry, Busan Paik Hospital, Inje University College of Medicine, Busan, Republic of Korea.'}, {'ForeName': 'Dong-Wook', 'Initials': 'DW', 'LastName': 'Jeon', 'Affiliation': 'Department of Psychiatry, Busan Paik Hospital, Inje University College of Medicine, Busan, Republic of Korea.'}, {'ForeName': 'Young-Soo', 'Initials': 'YS', 'LastName': 'Seo', 'Affiliation': 'Department of Psychiatry, Sharing and Happiness Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Sung-Soo', 'Initials': 'SS', 'LastName': 'Jung', 'Affiliation': 'Department of Psychiatry, Sharing and Happiness Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Yoo-Chul', 'Initials': 'YC', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Busan Metropolitan Mental Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Jeong-Eun', 'Initials': 'JE', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Busan Metropolitan Mental Hospital, Busan, Republic of Korea.'}]",Schizophrenia research,['10.1016/j.schres.2020.03.036']
641,32209700,Dietary Fats and Atherosclerosis From Childhood to Adulthood.,"BACKGROUND


The association of dietary fat distribution with markers of subclinical atherosclerosis during early life is unknown. We examined whether success in achieving the main target of an infancy-onset dietary intervention based on the distribution of dietary fat was associated with aortic and carotid intima-media thickness (IMT) and distensibility from childhood to young adulthood.
METHODS


In the prospective randomized controlled Special Turku Coronary Risk Factor Intervention Project trial, personalized dietary counseling was given biannually to healthy children from infancy to young adulthood. The counseling was based on Nordic Nutrition Recommendations, with the main aim of improving the distribution of dietary fat in children's diets. IMT and distensibility of the abdominal aorta and common carotid artery were measured repeatedly at ages 11 ( n  = 439), 13 ( n  = 499), 15 ( n  = 506), 17 ( n  = 477), and 19 years ( n  = 429). The targeted distribution of dietary fat was defined as a ratio of saturated fatty acids to monounsaturated and polyunsaturated fatty acids of <1:2 and as an intake of saturated fatty acids of <10% of energy intake. Participants who met ≥1 of these 2 criteria were defined to achieve the main intervention target.
RESULTS


Individuals who achieved the main intervention target had lower aortic IMT (age- and sex-adjusted mean difference 10.4 µm; 95% confidence interval: 0.3 to 20.5 µm) and better aortic distensibility (0.13% per 10 mm Hg; 95% confidence interval: 0.00% to 0.26% per10 mm Hg) compared with their peers who did not meet the target.
CONCLUSIONS


Achieving the main target of an infancy-onset dietary intervention, reflecting dietary guidelines, was favorably associated with aortic IMT and distensibility during the early life course. These data support the recommendation of favoring unsaturated fat to enhance arterial health.",2020,"RESULTS


Individuals who achieved the main intervention target had lower aortic IMT (age- and sex-adjusted mean difference 10.4 µm; 95% confidence interval: 0.3 to 20.5 µm) and better aortic distensibility (0.13% per 10 mm Hg; 95% confidence interval: 0.00% to 0.26% per10 mm Hg) compared with their peers who did not meet the target.
","['Participants who met ≥1 of these 2 criteria were defined to achieve the main intervention target', 'healthy children from infancy to young adulthood', 'ages 11 ( n  = 439), 13 ( n  = 499), 15 ( n  = 506), 17 ( n  = 477), and 19 years ( n  = 429', ""children's diets""]",['personalized dietary counseling'],"['lower aortic IMT', 'IMT and distensibility of the abdominal aorta and common carotid artery', 'aortic distensibility', 'aortic IMT and distensibility']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0231330', 'cui_str': 'Infancy - period'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0700597', 'cui_str': 'Adulthood - period'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0003484', 'cui_str': 'Aorta, Abdominal'}, {'cui': 'C0162859', 'cui_str': 'Common carotid artery structure'}]",,0.0710509,"RESULTS


Individuals who achieved the main intervention target had lower aortic IMT (age- and sex-adjusted mean difference 10.4 µm; 95% confidence interval: 0.3 to 20.5 µm) and better aortic distensibility (0.13% per 10 mm Hg; 95% confidence interval: 0.00% to 0.26% per10 mm Hg) compared with their peers who did not meet the target.
","[{'ForeName': 'Tomi T', 'Initials': 'TT', 'LastName': 'Laitinen', 'Affiliation': 'Research Centre of Applied and Preventive Cardiovascular Medicine and Centre for Population Health Research and tomi.laitinen@utu.fi.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Nuotio', 'Affiliation': 'Research Centre of Applied and Preventive Cardiovascular Medicine and Centre for Population Health Research and.'}, {'ForeName': 'Suvi P', 'Initials': 'SP', 'LastName': 'Rovio', 'Affiliation': 'Research Centre of Applied and Preventive Cardiovascular Medicine and Centre for Population Health Research and.'}, {'ForeName': 'Harri', 'Initials': 'H', 'LastName': 'Niinikoski', 'Affiliation': 'Departments of Pediatrics and Adolescent Medicine.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Juonala', 'Affiliation': 'Medicine, and.'}, {'ForeName': 'Costan G', 'Initials': 'CG', 'LastName': 'Magnussen', 'Affiliation': 'Research Centre of Applied and Preventive Cardiovascular Medicine and Centre for Population Health Research and.'}, {'ForeName': 'Eero', 'Initials': 'E', 'LastName': 'Jokinen', 'Affiliation': 'Department of Pediatric Cardiology, University of Helsinki and Hospital for Children and Adolescents, Helsinki, Finland; and.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Lagström', 'Affiliation': 'Public Health, University of Turku, Turku, Finland.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Jula', 'Affiliation': 'Department of Chronic Disease Prevention, Institute for Health and Welfare, Turku, Finland.'}, {'ForeName': 'Jorma S A', 'Initials': 'JSA', 'LastName': 'Viikari', 'Affiliation': 'Medicine, and.'}, {'ForeName': 'Tapani', 'Initials': 'T', 'LastName': 'Rönnemaa', 'Affiliation': 'Medicine, and.'}, {'ForeName': 'Olli', 'Initials': 'O', 'LastName': 'Simell', 'Affiliation': 'Research Centre of Applied and Preventive Cardiovascular Medicine and Centre for Population Health Research and.'}, {'ForeName': 'Olli T', 'Initials': 'OT', 'LastName': 'Raitakari', 'Affiliation': 'Research Centre of Applied and Preventive Cardiovascular Medicine and Centre for Population Health Research and.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Pahkala', 'Affiliation': 'Research Centre of Applied and Preventive Cardiovascular Medicine and Centre for Population Health Research and.'}]",Pediatrics,['10.1542/peds.2019-2786']
642,31904995,Outcomes Six Months after Delivering 100% or 70% of Enteral Calorie Requirements during Critical Illness (TARGET). A Randomized Controlled Trial.,"Rationale:  The long-term effects of delivering approximately 100% of recommended calorie intake via the enteral route during critical illness compared with a lesser amount of calories are unknown. Objectives:  Our hypotheses were that achieving approximately 100% of recommended calorie intake during critical illness would increase quality-of-life scores, return to work, and key life activities and reduce death and disability 6 months later. Methods:  We conducted a multicenter, blinded, parallel group, randomized clinical trial, with 3,957 mechanically ventilated critically ill adults allocated to energy-dense (1.5 kcal/ml) or routine (1.0 kcal/ml) enteral nutrition. Measurements and Main Results:  Participants assigned energy-dense nutrition received more calories (percent recommended energy intake, mean [SD]; energy-dense: 103% [28] vs. usual: 69% [18]). Mortality at Day 180 was similar (560/1,895 [29.6%] vs. 539/1,920 [28.1%]; relative risk 1.05 [95% confidence interval, 0.95-1.16]). At a median (interquartile range) of 185 (182-193) days after randomization, 2,492 survivors were surveyed and reported similar quality of life (EuroQol five dimensions five-level quality-of-life questionnaire visual analog scale, median [interquartile range]: 75 [60-85]; group difference: 0 [95% confidence interval, 0-0]). Similar numbers of participants returned to work with no difference in hours worked or effectiveness at work ( n  = 818). There was no observed difference in disability ( n  = 1,208) or participation in key life activities ( n  = 705). Conclusions:  The delivery of approximately 100% compared with 70% of recommended calorie intake during critical illness does not improve quality of life or functional outcomes or increase the number of survivors 6 months later.",2020,Similar numbers of participants returned to work with no difference in hours worked or effectiveness at work (n=818).,['3957 mechanically ventilated critically ill adults allocated to'],['energy-dense (1.5 kcal/ml) or routine (1.0 kcal/ml) enteral nutrition'],"['quality of life (EuroQol five dimensions five-level quality of life questionnaire visual analogue scale, median [IQR', 'quality of life scores, return to work and key life activities and reduce death and disability six months later', 'Mortality', 'quality of life, or functional outcomes', 'disability (n=1208) or participation in key life activities']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0560598', 'cui_str': 'kcal/mL'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}]","[{'cui': 'C0034380'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0425105', 'cui_str': 'Back to Work'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",,0.628334,Similar numbers of participants returned to work with no difference in hours worked or effectiveness at work (n=818).,"[{'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Deane', 'Affiliation': 'Department of Medicine and Radiology, Melbourne Medical School, Royal Melbourne Hospital and.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Little', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Centre for Integrated Critical Care, Melbourne Medical School, The University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Marianne J', 'Initials': 'MJ', 'LastName': 'Chapman', 'Affiliation': 'Discipline of Acute Care Medicine and.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Davies', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Suzie', 'Initials': 'S', 'LastName': 'Ferrie', 'Affiliation': 'Department of Nutrition and Dietetics, Royal Prince Alfred Hospital, Camperdown, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'Centre of Research Excellence in Translating Nutritional Science to Good Health, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Hurford', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Lange', 'Affiliation': 'Centre of Research Excellence in Translating Nutritional Science to Good Health, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Litton', 'Affiliation': 'Fiona Stanley Hospital, Perth, Australia.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Mackle', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': ""O'Connor"", 'Affiliation': 'Discipline of Acute Care Medicine and.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Parker', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Sandra L', 'Initials': 'SL', 'LastName': 'Peake', 'Affiliation': 'Discipline of Acute Care Medicine and.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Presneill', 'Affiliation': 'Department of Medicine and Radiology, Melbourne Medical School, Royal Melbourne Hospital and.'}, {'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Ridley', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Singh', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'van Haren', 'Affiliation': 'Medical School, Australian National University, Canberra, Australia; and.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Williams', 'Affiliation': 'Discipline of Acute Care Medicine and.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Young', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Theodore J', 'Initials': 'TJ', 'LastName': 'Iwashyna', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201909-1810OC']
643,32234329,"Volixibat in adults with non-alcoholic steatohepatitis: 24-week interim analysis from a randomized, phase II study.","BACKGROUND & AIMS


Volixibat is an inhibitor of the apical sodium-dependent bile acid transporter (ASBT) that has been hypothesized to improve non-alcoholic steatohepatitis (NASH) by blocking bile acid reuptake and stimulating hepatic bile acid production. We studied the safety, tolerability and efficacy of volixibat in patients with NASH.
METHODS


In this double-blind, phase II dose-finding study, adults with ≥5% steatosis and NASH without cirrhosis (N = 197) were randomized to receive volixibat (5, 10 or 20 mg) or placebo once daily for 48 weeks. The endpoints of a predefined interim analysis (n = 80), at week 24, were: ≥5% reduction in MRI-proton density fat fraction and ≥20% reduction in serum alanine aminotransferase levels. The primary endpoint was a ≥2-point reduction in non-alcoholic fatty liver disease activity score without worsening fibrosis at week 48.
RESULTS


Volixibat did not meet either interim endpoint; the study was terminated owing to lack of efficacy. In participants receiving any volixibat dose, mean serum 7-alpha-hydroxy-4-cholesten-3-one (C4; a biomarker of bile acid synthesis) increased from baseline to week 24 (+38.5 ng/ml [SD 53.18]), with concomitant decreases in serum total cholesterol (-14.5 mg/dl [SD 28.32]) and low-density lipoprotein cholesterol (-16.1 mg/dl [SD 25.31]). These changes were generally dose-dependent. On histological analysis, a greater proportion of participants receiving placebo (38.5%, n = 5/13) than volixibat (30.0%, n = 9/30) met the primary endpoint. Treatment-emergent adverse events (TEAEs) were mainly mild or moderate. No serious TEAEs were related to volixibat. Diarrhoea was the most common TEAE overall and the most common TEAE leading to discontinuation.
CONCLUSIONS


Increased serum C4 and decreased serum cholesterol levels provide evidence of target engagement. However, inhibition of ASBT by volixibat did not elicit a liver-related therapeutic benefit in adults with NASH.
LAY SUMMARY


A medicine called volixibat has previously been shown to reduce cholesterol levels in the blood. This study investigated whether volixibat could reduce the amount of fat in the liver and reduce liver injury in adults with an advanced form of non-alcoholic fatty liver disease. Volixibat did not reduce the amount of fat in the liver, nor did it have any other beneficial effect on liver injury. Participants in the study generally tolerated the side effects of volixibat and, as in previous studies, the main side effect was diarrhoea. These results show that volixibat is not an effective treatment for people with fatty liver disease.
CLINICAL TRIAL IDENTIFIER


NCT02787304.",2020,A predefined interim analysis (n = 80) at week 24 had endpoints of ≥5% reduction in magnetic resonance imaging-proton density fat fraction and ≥20% reduction in serum alanine aminotransferase levels.,"['Adults with ≥5% steatosis and NASH without cirrhosis (N = 197', 'adults with non-alcoholic steatohepatitis']",['placebo'],"['Diarrhoea', 'serum total cholesterol', 'serum cholesterol levels', 'low-density lipoprotein cholesterol', 'mean serum 7-alpha-hydroxy-4-cholesten-3-one (C4; a biomarker of bile acid synthesis', 'serum alanine aminotransferase levels', '≥2-point reduction in non-alcoholic fatty liver disease activity score without worsening fibrosis']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0587184', 'cui_str': 'Serum cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0049730', 'cui_str': '7 alpha-hydroxy-4-cholesten-3-one'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}]",197.0,0.566627,A predefined interim analysis (n = 80) at week 24 had endpoints of ≥5% reduction in magnetic resonance imaging-proton density fat fraction and ≥20% reduction in serum alanine aminotransferase levels.,"[{'ForeName': 'Philip N', 'Initials': 'PN', 'LastName': 'Newsome', 'Affiliation': 'National Institute for Health Research, Birmingham Biomedical Research Centre at the University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK; Centre for Liver and Gastrointestinal Research, Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UK. Electronic address: p.n.newsome@bham.ac.uk.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Palmer', 'Affiliation': 'Shire Plc, a Takeda company, Lexington, MA, USA.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Freilich', 'Affiliation': 'Kansas City Research Institute, Kansas City, MO, USA.'}, {'ForeName': 'Muhammad Y', 'Initials': 'MY', 'LastName': 'Sheikh', 'Affiliation': 'Fresno Clinical Research Center, Fresno, CA, USA.'}, {'ForeName': 'Aasim', 'Initials': 'A', 'LastName': 'Sheikh', 'Affiliation': 'GI Specialists of Georgia, Marietta, GA, USA.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Sarles', 'Affiliation': 'DHAT Research Institute, Garland, TX, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Herring', 'Affiliation': 'Quality Medical Research, PLLC, Nashville, TN, USA.'}, {'ForeName': 'Parvez', 'Initials': 'P', 'LastName': 'Mantry', 'Affiliation': 'Methodist Health System Clinical Research Institute, Dallas, TX, USA.'}, {'ForeName': 'Zeid', 'Initials': 'Z', 'LastName': 'Kayali', 'Affiliation': 'Inland Empire Liver Foundation, Rialto, CA, USA.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Hassanein', 'Affiliation': 'Southern California Research Center, Coronado, CA, USA.'}, {'ForeName': 'Hak-Myung', 'Initials': 'HM', 'LastName': 'Lee', 'Affiliation': 'Shire Plc, a Takeda company, Lexington, MA, USA.'}, {'ForeName': 'Guruprasad P', 'Initials': 'GP', 'LastName': 'Aithal', 'Affiliation': 'National Institute for Health Research, Nottingham Biomedical Research Centre at the Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, UK; Nottingham Digestive Diseases Centre, School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of hepatology,['10.1016/j.jhep.2020.03.024']
644,31860328,Temporal Factors and Missed Doses of Tuberculosis Treatment. A Causal Associations Approach to Analyses of Digital Adherence Data.,"Rationale:  Tuberculosis treatment lasts for 6 months or more. Treatment adherence is critical; regimen length, among other factors, makes this challenging. Globally, analyses mapping common types of nonadherence are lacking. For example, is there a greater challenge resulting from early treatment cessation (discontinuation) or intermittent missed doses (suboptimal dosing implementation)? This is essential knowledge for the development of effective interventions and more ""forgiving"" regimens, as well as to direct national tuberculosis programs. Objectives:  To granularly describe how patients take their tuberculosis medication and the temporal factors associated with missed doses. Methods:  The present study included patients with pulmonary tuberculosis enrolled in the control arm of a pragmatic, cluster-randomized trial in China of electronic reminders to improve treatment adherence. Treatment was the standard 6-month course (180 d), dosed every other day (90 doses). Medication monitor boxes recorded adherence (box opening) without prompting reminders. Patterns of adherence were visualized and described. Mixed-effects logistic regression models examined the temporal factors associated with per-dose suboptimal dosing implementation, adjusting for clustering within a participant. Cox regression models were used to examine the association between early suboptimal dosing implementation and permanent discontinuation. Results:  Across 780 patients, 16,794 (23.9%) of 70,200 doses were missed, 9,487 of which were from suboptimal dosing implementation (56.5%). By 60 days, 5.1% of participants had discontinued, and 14.4% had discontinued by 120 days. Most participants (95.9%) missed at least one dose. The majority of gaps were of a single dose (71.4%), although 22.6% of participants had at least one gap of 2 weeks or more. In adjusted models, the initiation-continuation phase transition (odds ratio, 3.07 [95% confidence interval, 2.68-3.51]) and national holidays (1.52 [1.39-1.65]) were associated with increased odds of suboptimal dosing implementation. Early-stage suboptimal dosing implementation was associated with increased discontinuation rates. Conclusions:  Digital tools provide an unprecedented step change in describing and addressing nonadherence. In our setting, nonadherence was common; patients displayed a complex range of patterns. Dividing nonadherence into suboptimal dosing implementation and discontinuation, we found that both increased over time. Discontinuation was associated with early suboptimal dosing implementation. These apparent causal associations between temporal factors and nonadherence present opportunities for targeted interventions.Clinical trial registered with the ISRCTN Registry (ISRCTN46846388).",2020,"In adjusted models, the initiation-continuation phase transition (odds ratio 3.07 [95% confidence interval 2.68-3.51]) and national holidays (1.52 [1.39-1.65]) were associated with increasing odds of suboptimal dosing implementation.","['780 patients, 16,794 of 70,200 doses were missed (23.9%), 9,487 from suboptimal dosing implementation (56.5', 'Pulmonary tuberculosis patients enrolled in the control arm of a pragmatic cluster-randomized trial in China of']","['electronic reminders', 'Tuberculosis Treatment']",['national holidays'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary Phthisis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],780.0,0.0701584,"In adjusted models, the initiation-continuation phase transition (odds ratio 3.07 [95% confidence interval 2.68-3.51]) and national holidays (1.52 [1.39-1.65]) were associated with increasing odds of suboptimal dosing implementation.","[{'ForeName': 'Helen R', 'Initials': 'HR', 'LastName': 'Stagg', 'Affiliation': 'Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Lewis', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Xiaoqiu', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Shitong', 'Initials': 'S', 'LastName': 'Huan', 'Affiliation': 'China Office, Bill & Melinda Gates Foundation, Beijing, China; and.'}, {'ForeName': 'Shiwen', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': 'National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Chin', 'Affiliation': 'China Office, Bill & Melinda Gates Foundation, Beijing, China; and.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Fielding', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201905-394OC']
645,32238920,Ki-67 response-guided preoperative chemotherapy for HER2-positive breast cancer: results of a randomised Phase 2 study.,"BACKGROUND


The effectiveness of a therapeutic strategy that switches chemotherapy, based on Ki-67 tumour expression after initial therapy, relative to that of standard chemotherapy, has not been evaluated.
METHODS


Patients were randomly assigned to the control arm or the Ki-67 response-guided arm (Ki-67 arm). Primary tumour biopsies were obtained before treatment, and after three once-weekly doses of paclitaxel and trastuzumab to assess the interim Ki-67 index. In the control arm, paclitaxel and trastuzumab were continued for a total of 12 doses, regardless of the interim Ki-67 index. In the Ki-67 arm, subsequent treatment was based on the interim Ki-67 index. Ki-67 early responder is defined as the absolute Ki-67 value that was <10%, and the percentage of Ki-67-positive tumour cells was reduced by >30% compared with before treatment. Early Ki-67 responders continued to receive the same treatment, while early Ki-67 non-responders were switched to epirubicin plus cyclophosphamide. The primary endpoint was the pathological complete response (pCR) rate.
RESULTS


A total of 237 patients were randomised. There was almost linear correlation between the Ki-67 reduction rate at interim assessment and the pCR rate. The pCR rate in Ki-67 early non-responders in the Ki-67 arm was inferior to that in the control arm (44.1%; 31.4-56.7; P = 0.025).
CONCLUSIONS


The standard chemotherapy protocol remains as the recommended strategy for patients with HER2-positive breast cancer.
CLINICAL TRIAL REGISTRATION


Clinical Trial Registration: UMIN-CTR as UMIN000007074.",2020,"The pCR rate in Ki-67 early non-responders in the Ki-67 arm was inferior to that in the control arm (44.1%; 31.4-56.7; P = 0.025).
","['patients with HER2-positive breast cancer', '237 patients were randomised', 'HER2-positive breast cancer', 'Patients']","['paclitaxel and trastuzumab', 'Ki-67 response-guided preoperative chemotherapy', 'epirubicin plus cyclophosphamide', 'Ki-67 response-guided arm (Ki-67 arm']","['pathological complete response (pCR) rate', 'absolute Ki-67 value', 'pCR rate', 'Ki-67 reduction rate', 'percentage of Ki-67-positive tumour cells']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant'}]",237.0,0.0497755,"The pCR rate in Ki-67 early non-responders in the Ki-67 arm was inferior to that in the control arm (44.1%; 31.4-56.7; P = 0.025).
","[{'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Mukai', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Chiba, 277-8577, Japan. hrmukai@east.ncc.go.jp.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Musashino Red Cross Hospital, Musashino, Tokyo, 180-0023, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'National Hospital Organization Hokkaido Cancer Center, Sapporo, Hokkaido, 003-0804, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Hozumi', 'Affiliation': 'University of Tsukuba Hospital, Tsukuba, Ibaraki, 305-8576, Japan.'}, {'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Fujisawa', 'Affiliation': 'Gunma Prefectural Cancer Center, Ota, Gunma, 373-0828, Japan.'}, {'ForeName': 'Shozo', 'Initials': 'S', 'LastName': 'Ohsumi', 'Affiliation': 'National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime, 791-0245, Japan.'}, {'ForeName': 'Hiromitsu', 'Initials': 'H', 'LastName': 'Akabane', 'Affiliation': 'Asahikawa-Kosei General Hospital, Hokkaido, Asahikawa, Japan.'}, {'ForeName': 'Reiki', 'Initials': 'R', 'LastName': 'Nishimura', 'Affiliation': 'Kumamoto Shinto General Hospital, Chuo Ward, Kumamoto, 862-8655, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takashima', 'Affiliation': 'Osaka City University Graduate School of Medicine, Sumiyoshi Ward, Osaka, 558-0022, Japan.'}, {'ForeName': 'Youngjin', 'Initials': 'Y', 'LastName': 'Park', 'Affiliation': 'Tohoku Medical and Pharmaceutical University Hospital, Sendai, Miyagi, 981-8558, Japan.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Sagara', 'Affiliation': 'Hakuaikai Medical Corp Sagara Hospital, Kagoshima, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Toyama', 'Affiliation': 'Nagoya City University Graduate School of Medical Sciences, Aichi, Nagoya, 467-8601, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Imoto', 'Affiliation': 'Kyorin University Hospital, Mitaka, Tokyo, 181-8611, Japan.'}, {'ForeName': 'Toshiro', 'Initials': 'T', 'LastName': 'Mizuno', 'Affiliation': 'Mie University Hospital, Tsu, Mie, 514-8507, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Yamashita', 'Affiliation': 'National Cancer Center Research Institute, Chuo-ku, Tokyo, 104-0045, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Fujii', 'Affiliation': 'Division of Pathology, Exploratory Oncology Research & Clinical Trial Center, National Cancer Center, Kashiwa, Chiba, 277-8577, Japan.'}, {'ForeName': 'Yukari', 'Initials': 'Y', 'LastName': 'Uemura', 'Affiliation': 'National Center for Global Health and Medicine, Tokyo, Japan.'}]",British journal of cancer,['10.1038/s41416-020-0815-9']
646,32234000,Has the Time Come to Employ Population and Individual Bioequivalence for the Evaluation of Generics?,"BACKGROUND


Bioequivalence studies are a vital part of drug development. The average bioequivalence approach is the standard method of assessment to conclude whether the generic product is bioequivalent to the innovator product. Of late, debates are on whether the average bioequivalence approach adequately addresses drug interchangeability as it considers only population mean for the evaluation especially when highly variable drug products and narrow therapeutic index drugs are dealt with. Hence, the alternative approaches like population bioequivalence and individual bioequivalence assessment approaches emerge as they consider inter/intra-subject variance and subject- by-formulation variance along with population mean.
OBJECTIVES


The objective of the study was to apply different bioequivalence assessment approaches in a replicate bioequivalence study to evaluate the drug interchangeability.
METHODS


This was an open-label, single-dose, randomized, balanced, two-treatment, three-period, three-sequence, partial replicate crossover bioequivalence study of omeprazole enteric-coated tablet 20 mg conducted on 48 normal healthy subjects under fed conditions. The plasma concentration of omeprazole was analyzed by a validated bioanalytical method to determine the pharmacokinetic and statistical parameters to assess average bioequivalence, population bioequivalence, and individual bioequivalence.
RESULTS


In this study, test formulation was shown to be bio-inequivalent to the reference formulation by average bioequivalence, population bioequivalence, and individual bioequivalence approaches.
CONCLUSION


The outcome of the evaluation clearly states that the bioequivalence outcome of all these approaches are the same. Obviously, it does not mean that these three approaches provide the same outcome though the consideration of variances varies. Certainly, population bioequivalence and individual bioequivalence approach will be more accurate for the assessment of drug interchangeability.",2020,"In this study, test formulation was shown to be bio-inequivalent to the reference formulation by average bioequivalence, population bioequivalence and individual bioequivalence approaches.
",['48 normal healthy subjects under fed conditions'],['Omeprazole enteric coated tablet'],['plasma concentration of Omeprazole'],"[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0342895', 'cui_str': 'Fish-eye disease'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C0039226', 'cui_str': 'Gastro-resistant oral tablet'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}]",48.0,0.0218843,"In this study, test formulation was shown to be bio-inequivalent to the reference formulation by average bioequivalence, population bioequivalence and individual bioequivalence approaches.
","[{'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Micheal', 'Affiliation': 'Department of Chemistry, School of Advanced Sciences, VIT University, Vellore, Tamilnadu 632014, India.'}, {'ForeName': 'Mohanlal', 'Initials': 'M', 'LastName': 'Sayana', 'Affiliation': 'Department of Pharmacokinetic and Drug Metabolism, Strides Pharma Science Limited, Bangalore, Karnataka 560076, India.'}, {'ForeName': 'Rajendra', 'Initials': 'R', 'LastName': 'Prasad', 'Affiliation': 'Department of Pharmacokinetics and Drug Metabolism, Jeevan Scientific Technology Limited, Hyderabad, Telangana 500008, India.'}, {'ForeName': 'Balamurali Musuvathi', 'Initials': 'BM', 'LastName': 'Motilal', 'Affiliation': 'Department of Chemistry, School of Advanced Sciences, VIT University, Vellore, Tamilnadu 632014, India.'}]",Current drug metabolism,['10.2174/1389200221666200401105119']
647,32234715,Subcutaneous tanezumab for osteoarthritis of the hip or knee: efficacy and safety results from a 24-week randomised phase III study with a 24-week follow-up period.,"OBJECTIVE


Tanezumab, a nerve growth factor inhibitor, was investigated for osteoarthritis (OA) of the hip or knee in a study with 24-week treatment and 24-week safety follow-up.
METHODS


This double-blind, randomised, phase III study enrolled adults in Europe and Japan with moderate-to-severe OA who had not responded to or could not tolerate standard-of-care analgesics. Patients were randomised to tanezumab 2.5 mg or 5 mg subcutaneously or matching placebo every 8 weeks (three doses). Co-primary end points were change from baseline to week 24 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain and Physical Function, and Patient's Global Assessment of OA (PGA-OA). Joint safety and neurological assessments continued throughout the 48-week study.
RESULTS


From March 2016 to December 2017, 849 patients were randomised and evaluated (placebo n=282, tanezumab 2.5 mg n=283, tanezumab 5 mg n=284). At week 24, there was a statistically significant improvement from baseline for tanezumab 5 mg compared with placebo for WOMAC Pain (least squares mean difference±SE -0.62±0.18, p=0.0006), WOMAC Physical Function (-0.71±0.17, p<0.0001) and PGA-OA (-0.19±0.07, p=0.0051). For tanezumab 2.5 mg, there was a statistically significant improvement in WOMAC Pain and Physical Function, but not PGA-OA. Rapidly progressive osteoarthritis (RPOA) was observed in 1.4% (4/283) and 2.8% (8/284) of patients in the tanezumab 2.5 mg and tanezumab 5 mg groups, respectively and none receiving placebo. Total joint replacements (TJRs) were similarly distributed across all three treatment groups (6.7%-7.8%). Tanezumab-treated patients experienced more paraesthesia (5 mg) and hypoaesthesia (both doses) than placebo.
CONCLUSION


Tanezumab 5 mg statistically significantly improved pain, physical function and PGA-OA, but tanezumab 2.5 mg only achieved two co-primary end points. RPOA occurred more frequently with tanezumab 5 mg than tanezumab 2.5 mg. TJRs were similarly distributed across all three groups.
TRIAL REGISTRATION NUMBER


NCT02709486.",2020,"For tanezumab 2.5 mg, there was a statistically significant improvement in WOMAC Pain and Physical Function, but not PGA-OA.","['osteoarthritis of the hip or knee', 'From March 2016 to December 2017, 849 patients were randomised and evaluated ', 'phase III study enrolled adults in Europe and Japan with moderate-to-severe OA who had not responded to or could not tolerate standard-of-care analgesics']","['placebo n=282, tanezumab 2.5\u2009mg n=283, tanezumab', 'placebo', 'tanezumab', 'Tanezumab', 'tanezumab 2.5 mg or 5\u2009mg subcutaneously or matching placebo', 'Subcutaneous tanezumab']","['RPOA', 'paraesthesia', 'pain, physical function and PGA-OA', 'WOMAC Physical Function', 'Rapidly progressive osteoarthritis (RPOA', 'Total joint replacements (TJRs', 'WOMAC Pain', 'Western Ontario and McMaster Universities Osteoarthritis Index', 'Joint safety and neurological assessments', 'WOMAC Pain and Physical Function', ""WOMAC) Pain and Physical Function, and Patient's Global Assessment of OA (PGA-OA""]","[{'cui': 'C0029410', 'cui_str': 'Osteoarthritis of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2346819', 'cui_str': 'tanezumab'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C3854438', 'cui_str': 'Rapidly progressive osteoarthritis'}, {'cui': 'C4279925', 'cui_str': 'Total Joint Replacement'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027853', 'cui_str': 'Neurological examination'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",849.0,0.0446766,"For tanezumab 2.5 mg, there was a statistically significant improvement in WOMAC Pain and Physical Function, but not PGA-OA.","[{'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Berenbaum', 'Affiliation': 'Department of Rheumatology, Sorbonne Université, INSERM CRSA, AP-HP Hopital Saint Antoine, Paris, France francis.berenbaum@aphp.fr.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Blanco', 'Affiliation': 'Servicio de Reumatología, INIBC-Complejo Hospitalario Universitario A Coruña, La Coruña, Spain.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Guermazi', 'Affiliation': 'Department of Radiology, Boston University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Miki', 'Affiliation': 'Faculty of Health Science, Osaka Yukioka College of Health Science, Hayaishi Hospital, Osaka, Japan.'}, {'ForeName': 'Takaharu', 'Initials': 'T', 'LastName': 'Yamabe', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Viktrup', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Rod', 'Initials': 'R', 'LastName': 'Junor', 'Affiliation': 'Pfizer Ltd, Tadworth, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Carey', 'Affiliation': 'Pfizer Ltd, Tadworth, UK.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Brown', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Christine R', 'Initials': 'CR', 'LastName': 'West', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Kenneth M', 'Initials': 'KM', 'LastName': 'Verburg', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216296']
648,30664661,Psychiatric adverse events and effects on mood with prolonged-release naltrexone/bupropion combination therapy: a pooled analysis.,"BACKGROUND/OBJECTIVES


Prolonged-release (PR) naltrexone 32 mg/bupropion 360 mg (NB) is approved for chronic weight management as an adjunct to reduced-calorie diet and increased physical activity. Central nervous system-active medications have the potential to affect mood; therefore, post hoc analysis of clinical trial data was conducted to evaluate psychiatric adverse events (PAEs) and effects on mood of NB therapy versus placebo.
SUBJECTS/METHODS


Data were pooled from 5 prospective, double-blind, randomized, placebo-controlled clinical trials (duration range, 24-56 weeks) of NB in subjects with overweight or obesity. PAEs were collected via AE preferred terms, organized into major subtopics (e.g., anxiety, depression, sleep disorders), and divided into category terms (e.g., anxiety, potential anxiety symptoms). Additionally, the Inventory of Depressive Symptomatology Self Report (IDS-SR; score range 0-84) and the Columbia Classification Algorithm of Suicide Assessment (C-CASA) evaluated treatment-emergent depressive/anxiety symptoms and suicidal behavior/ideation, respectively.
RESULTS


Baseline characteristics and comorbidities were comparable for placebo (n = 1515) and NB (n = 2545). Most common PAEs in the NB group (using category grouping; NB vs placebo) were sleep disorders (12.7 vs 7.9%, P < 0.001), anxiety (5.4 vs 3.3%, P = 0.029), and depression (1.8 vs 2.7%, P = 0.014); PAEs were more frequent during dose escalation and generally mild or moderate. Mean (SD) changes in IDS-SR total score from baseline to endpoint were small in both groups: 0.13 (5.83) for NB and -0.45 (5.65) for placebo. Retrospective AE categorization via C-CASA confirmed no completed suicides, suicide attempts, or preparatory acts toward imminent suicidal behavior.
CONCLUSIONS


This large pooled analysis of 5 clinical trials provides additional safety information about the NB PAE profile. Anxiety and sleep disorder-related PAEs were more frequent with NB versus placebo but were mostly mild to moderate and generally occurred early. Depression-related PAEs were less common with NB than placebo, and NB was not associated with suicidal ideation or behavior in this patient population.",2019,"Depression-related PAEs were less common with NB than placebo, and NB was not associated with suicidal ideation or behavior in this patient population.",['subjects with overweight or obesity'],"['naltrexone/bupropion combination therapy', 'bupropion 360\u2009mg (NB', 'placebo']","['Depression-related PAEs', 'depression', 'suicidal ideation or behavior', 'Inventory of Depressive Symptomatology Self Report (IDS-SR; score range 0-84) and the Columbia Classification Algorithm of Suicide Assessment (C-CASA) evaluated treatment-emergent depressive/anxiety symptoms and suicidal behavior/ideation, respectively', 'Psychiatric adverse events', 'Mean (SD) changes in IDS-SR total score', 'Anxiety and sleep disorder-related PAEs', 'anxiety', 'sleep disorders']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0002045'}, {'cui': 'C3494753', 'cui_str': 'Suicide evaluation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior (finding)'}, {'cui': 'C0392348', 'cui_str': 'Ideation, function (observable entity)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}]",,0.497082,"Depression-related PAEs were less common with NB than placebo, and NB was not associated with suicidal ideation or behavior in this patient population.","[{'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Apovian', 'Affiliation': 'Boston University School of Medicine and Department of Medicine Section of Endocrinology, Diabetes and Nutrition, Boston Medical Center, Boston, MA, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'McElroy', 'Affiliation': 'Lindner Center of HOPE, Mason, and Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, OH, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Dunayevich', 'Affiliation': 'Annexon Biosciences, South San Francisco, CA, USA.'}, {'ForeName': 'Lisette M', 'Initials': 'LM', 'LastName': 'Acevedo', 'Affiliation': 'Nalpropion Pharmaceuticals, Inc, La Jolla, CA, USA.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Greenway', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA. frank.greenway@pbrc.edu.'}]",International journal of obesity (2005),['10.1038/s41366-018-0302-z']
649,30793375,Comparing web-based video interventions to enhance university student willingness to donate organs: A randomized controlled trial.,"BACKGROUND


The efficacy of video interventions to increase organ donation willingness remains unclear.
METHODS


Three-arm web-based randomized controlled trial involving 2261 students at 3 northeastern Ohio universities. Intervention students watched a live-action (n = 755) or animated (n = 753) donation video. Control students (n = 753) viewed wellness information from the Centers for Disease Control and Prevention (CDC). The primary outcome was proportion of students who visited their state electronic donor registry to consent. The secondary outcome was intervention quality. Logistic regression assessed the effects of interventions on visiting the state registry to provide donation consent while controlling for baseline variables.
RESULTS


Students in the live-action video arm visited their state registry more frequently than students in the CDC arm (OR = 1.86, 95% CI = 1.20-2.88). There was no difference between students in the animated video and CDC arms (OR = 1.10, 95% CI = 0.69-1.76). The quality of the live-action video was rated lower than the animated video and the CDC text (75% ± 18, 84% ± 16, 80% ± 16, respectively; P < 0.001).
CONCLUSION


Students who watched the live-action video were more willing to visit their electronic donor registry to register as organ donors, but rated it lower in satisfaction. Future work should identify the most potent components of organ donation interventions.",2019,"There was no difference between students in the animated video and CDC arms (OR = 1.10, 95% CI = 0.69-1.76).","['2261 students at 3 northeastern Ohio universities', 'Control students (n\xa0=\xa0753']","['live-action (n\xa0=\xa0755) or animated (n\xa0=\xa0753) donation video', 'web-based video interventions', 'video interventions', 'viewed wellness information from the Centers for Disease Control and Prevention (CDC']","['quality of the live-action video', 'proportion of students who visited their state electronic donor registry to consent']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0028905', 'cui_str': 'Ohio'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C4517872', 'cui_str': 'Seven hundred and fifty-five'}, {'cui': 'C4049936', 'cui_str': 'Donation'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0007670', 'cui_str': 'CDC'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}]",2261.0,0.110195,"There was no difference between students in the animated video and CDC arms (OR = 1.10, 95% CI = 0.69-1.76).","[{'ForeName': 'J Daryl', 'Initials': 'JD', 'LastName': 'Thornton', 'Affiliation': 'Center for Reducing Health Disparities, MetroHealth Campus of Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Patrick', 'Affiliation': 'Department of Surgery, University Hospitals Cleveland Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sullivan', 'Affiliation': 'Center for Reducing Health Disparities, MetroHealth Campus of Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Albert', 'Affiliation': 'Department of Population and Quantitative Health Sciences, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Kristine A', 'Initials': 'KA', 'LastName': 'Wong', 'Affiliation': 'Oakland, California.'}, {'ForeName': 'Margaret D', 'Initials': 'MD', 'LastName': 'Allen', 'Affiliation': 'Benaroya Research Institute, Seattle, Washington.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Kimble', 'Affiliation': 'Cleveland Minority Organ Tissue Transplant Education Program (MOTTEP), Cleveland, Ohio.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Mekesa', 'Affiliation': 'LifeBanc, Cleveland, Ohio.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Bowen', 'Affiliation': 'LifeBanc, Cleveland, Ohio.'}, {'ForeName': 'Ashwini R', 'Initials': 'AR', 'LastName': 'Sehgal', 'Affiliation': 'Center for Reducing Health Disparities, MetroHealth Campus of Case Western Reserve University, Cleveland, Ohio.'}]",Clinical transplantation,['10.1111/ctr.13506']
650,32272792,The Effectiveness of the Good Affordable Food Intervention for Adults with Low Socioeconomic Status and Small Incomes.,"Good Affordable Food (GAF) is a small-group nutrition education intervention for adults with low socioeconomic status and small incomes. It aims to empower participants to save money on groceries and consume healthier diets. This paper reports the short-term and longer-term effects on behavioural determinants and self-reported behavioural changes. A quasi-experimental control group design was applied with a baseline measurement, a post-test immediately after the intervention, and a follow-up measurement after six months. The study included 237 participants (intervention group: n = 131; control group: n = 106) at baseline, 197 at post-test, and 152 at follow-up. Data were collected by telephone, mostly using closed interview questions. Positive short-term and longer-term effects were found for attitude towards the costs of healthy foods, food label use, and the use of liquid butter or oil to prepare hot meals. Short-term intervention effects related to knowledge towards saving money on groceries, self-efficacy towards healthy eating, portion size awareness, and mindful eating. GAF was effective in changing some determinants and behaviours related to cost and food consumption, however, mostly in the short term. Thereby, it is an example of combining pricing and health information in nutrition education that developers of effective nutrition education for low-income groups can build on.",2020,"Positive short-term and longer-term effects were found for attitude towards the costs of healthy foods, food label use, and the use of liquid butter or oil to prepare hot meals.","['adults with low socioeconomic status and small incomes', '237 participants (intervention group: n = 131; control group: n = 106) at baseline, 197 at post-test, and 152 at follow-up', 'Adults with Low Socioeconomic Status and Small Incomes']","['Good Affordable Food Intervention', 'GAF', 'Good Affordable Food (GAF']","['groceries, self-efficacy towards healthy eating, portion size awareness, and mindful eating']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C3658326', 'cui_str': 'Portion Size'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}]",237.0,0.0192813,"Positive short-term and longer-term effects were found for attitude towards the costs of healthy foods, food label use, and the use of liquid butter or oil to prepare hot meals.","[{'ForeName': 'Kathelijne M H H', 'Initials': 'KMHH', 'LastName': 'Bessems', 'Affiliation': 'NUTRIM School of Nutrition and Translational research in Metabolism, Maastricht University, P.O. Box 616, 6200MD Maastricht, The Netherlands.'}, {'ForeName': 'Evelyne', 'Initials': 'E', 'LastName': 'Linssen', 'Affiliation': 'Department of Knowledge & Innovation, Public Health Service South Limburg, P.O. Box 33, 6400 AA Heerlen, The Netherlands.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Lomme', 'Affiliation': 'Dietician Practice Lomme, Lichtenberg 27 6151BS, Munstergeleen, The Netherlands.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'van Assema', 'Affiliation': 'NUTRIM School of Nutrition and Translational research in Metabolism, Maastricht University, P.O. Box 616, 6200MD Maastricht, The Netherlands.'}]",International journal of environmental research and public health,['10.3390/ijerph17072535']
651,31922899,The Effect of Continuous Positive Airway Pressure on Vascular Function and Cardiac Structure in Diabetes and Sleep Apnea. A Randomized Controlled Trial.,"Rationale:  Although both type 2 diabetes mellitus (T2DM) and obstructive sleep apnea (OSA) are independently recognized as risk factors for cardiovascular disease, little is known about their interaction. Objectives:  We hypothesized that T2DM and OSA act synergistically to increase vascular risk, and that treatment of OSA would improve vascular reactivity in patients with T2DM plus OSA. Methods:  Cross-sectional study of 141 adults with T2DM, OSA, T2DM plus OSA, and control subjects, followed by a 3-month, parallel-arm, randomized, placebo-controlled trial comparing active and sham continuous positive airway pressure (CPAP) in 53 adults with T2DM plus OSA. Endothelium-dependent macro- and microvascular reactivity (flow-mediated dilation [FMD] of the brachial artery and acetylcholine-induced dilation of forearm microvasculature, respectively) and cardiovascular magnetic resonance to assess left- and right-ventricular mass/volume. Results:  Mean (±SD) FMD was 6.1 (±4.0)%, 7.3 (±3.6)%, 6.8 (±4.5)%, and 4.8 (±2.9)% in control subjects, T2DM only, OSA only, and T2DM plus OSA, respectively. We observed a significant T2DM × OSA interaction on FMD, such that the mean effect of OSA in those with T2DM was 3.1% (95% confidence interval [CI], 0.6 to 5.6) greater than the effect of OSA in those without T2DM. A total of 3 months of CPAP resulted in a mean absolute increase in FMD of 0.3% (95% CI, -1.9 to 2.5; primary endpoint), with a net improvement of 1.1% (95% CI, -1.4 to 3.6) among those with adherence of 4 h/night or greater. A significant T2DM × OSA interaction was found for both left ventricular (LV) and right ventricular end-diastolic volume, such that OSA was associated with a 22.4 ml (95% CI, 3.2 to 41.6) greater LV end-diastolic volume and 23.2 ml (95% CI, 2.6 to 43.8) greater right ventricular end-diastolic volume in those with T2DM compared with the impact of OSA in those without T2DM. We observed a net improvement in LV end-diastolic volume of 8.7 ml (95% CI, -7.0 to 24.4). Conclusions:  The combination of T2DM plus OSA is associated with macrovascular endothelial dysfunction beyond that observed with either disease alone. CPAP for 3 months did not significantly improve macrovascular endothelial function in the intent-to-treat analysis; however, cardiovascular magnetic resonance results suggest that there may be a beneficial effect of CPAP on LV diastolic volume.Clinical trial registered with www.clinicaltrials.gov (NCT01629862).",2020,"CPAP for 3-months did not significantly improve macro-vascular endothelial function in the intent-to-treat analysis; however, CMR results suggest that there may be a beneficial effect of CPAP on LV diastolic volume.","['141 adults with T2DM, OSA, T2DM+OSA, and controls', 'Diabetes and Sleep Apnea', '53 adults with T2DM+OSA', 'type 2 diabetes mellitus (T2DM) and obstructive sleep apnea (OSA']","['T2DM and OSA', 'placebo-controlled trial comparing active and sham continuous positive airway pressure (CPAP', 'T2DM+OSA', 'OSA', 'CPAP']","['RV end-diastolic volume', 'LV end-diastolic volume', 'Vascular Function and Cardiac Structure', 'LV diastolic volume', 'LV and RV end-diastolic volume, such that OSA', 'FMD', 'Endothelium-dependent macro- and micro-vascular reactivity (flow-mediated dilation (FMD', 'vascular reactivity', 'macro-vascular endothelial function']","[{'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0037315', 'cui_str': 'Sleep Hypopnea'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}]","[{'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0014257', 'cui_str': 'Endothelium'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0031843', 'cui_str': 'function'}]",141.0,0.155195,"CPAP for 3-months did not significantly improve macro-vascular endothelial function in the intent-to-treat analysis; however, CMR results suggest that there may be a beneficial effect of CPAP on LV diastolic volume.","[{'ForeName': 'Jessie P', 'Initials': 'JP', 'LastName': 'Bakker', 'Affiliation': ""Division of Sleep & Circadian Disorders, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Baltzis', 'Affiliation': 'The Rongxiang Xu MD Center for Regenerative Therapeutics.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Tecilazich', 'Affiliation': 'The Rongxiang Xu MD Center for Regenerative Therapeutics.'}, {'ForeName': 'Raymond H', 'Initials': 'RH', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Warren J', 'Initials': 'WJ', 'LastName': 'Manning', 'Affiliation': 'Department of Medicine, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Tomas G', 'Initials': 'TG', 'LastName': 'Neilan', 'Affiliation': 'Division of Cardiology, Department of Medicine and the Cardiovascular Imaging Research Center, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Meredith L', 'Initials': 'ML', 'LastName': 'Wallace', 'Affiliation': 'Department of Psychiatry and Department of Biostatistics, and.'}, {'ForeName': 'Margo', 'Initials': 'M', 'LastName': 'Hudson', 'Affiliation': 'Department of Medicine, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Malhotra', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, University of California, San Diego, San Diego, California.'}, {'ForeName': 'Sanjay R', 'Initials': 'SR', 'LastName': 'Patel', 'Affiliation': 'Center for Sleep and Cardiovascular Outcomes Research, Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Aristidis', 'Initials': 'A', 'LastName': 'Veves', 'Affiliation': 'The Rongxiang Xu MD Center for Regenerative Therapeutics.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201905-378OC']
652,30938764,Metformin Improves Peripheral Insulin Sensitivity in Youth With Type 1 Diabetes.,"CONTEXT


Type 1 diabetes in adolescence is characterized by insulin deficiency and insulin resistance (IR), both thought to increase cardiovascular disease risk. We previously demonstrated that adolescents with type 1 diabetes have adipose, hepatic, and muscle IR, and that metformin lowers daily insulin dose, suggesting improved IR. However, whether metformin improves IR in muscle, hepatic, or adipose tissues in type 1 diabetes was unknown.
OBJECTIVE


Measure peripheral, hepatic, and adipose insulin sensitivity before and after metformin or placebo therapy in youth with obesity with type 1 diabetes.
DESIGN


Double-blind, placebo-controlled clinical trial.
SETTING


Multi-center at eight sites of the T1D Exchange Clinic Network.
PARTICIPANTS


A subset of 12- to 19-year-olds with type 1 diabetes (inclusion criteria: body mass index ≥85th percentile, HbA1c 7.5% to 9.9%, insulin dosing ≥0.8 U/kg/d) from a larger trial (NCT02045290) were enrolled.
INTERVENTION


Participants were randomized to 3 months of metformin (N = 19) or placebo (N = 18) and underwent a three-phase hyperinsulinemic euglycemic clamp with glucose and glycerol isotope tracers to assess tissue-specific IR before and after treatment.
MAIN OUTCOME MEASURES


Peripheral insulin sensitivity, endogenous glucose release, rate of lipolysis.
RESULTS


Between-group differences in change in insulin sensitivity favored metformin regarding whole-body IR [change in glucose infusion rate 1.3 (0.1, 2.4) mg/kg/min, P = 0.03] and peripheral IR [change in metabolic clearance rate 0.923 (-0.002, 1.867) dL/kg/min, P = 0.05]. Metformin did not impact insulin suppression of endogenous glucose release (P = 0.12). Adipose IR was not assessable with traditional methods in this highly IR population.
CONCLUSIONS


Metformin appears to improve whole-body and peripheral IR in youth who are overweight/obese with type 1 diabetes.",2019,Metformin did not impact insulin suppression of endogenous glucose release (P = 0.12).,"['Multi-center at eight sites of the T1D Exchange Clinic Network', 'youth who are overweight/obese with type 1 diabetes', 'youth with obesity with type 1 diabetes', 'Youth With Type 1 Diabetes', 'adolescents with type 1 diabetes', 'A subset of 12- to 19-year-olds with type 1 diabetes (inclusion criteria: body mass index ≥85th percentile, HbA1c 7.5% to 9.9%, insulin dosing ≥0.8 U/kg/d) from a larger trial (NCT02045290) were enrolled']","['metformin or placebo therapy', 'placebo', 'metformin', 'hyperinsulinemic euglycemic clamp with glucose and glycerol isotope tracers', 'Metformin']","['insulin sensitivity', 'Adipose IR', 'Peripheral Insulin Sensitivity', 'peripheral IR [change in metabolic clearance rate', 'Peripheral insulin sensitivity, endogenous glucose release, rate of lipolysis', 'body IR [change in glucose infusion rate', 'endogenous glucose release', 'IR in muscle, hepatic, or adipose tissues']","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C2945843', 'cui_str': 'Site of (attribute)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1300561', 'cui_str': 'unit/kg'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0079318', 'cui_str': 'Glucose Clamp'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0022262', 'cui_str': 'Isotopes'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0025515', 'cui_str': 'Metabolic Clearance Rate'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0023796', 'cui_str': 'Lipolysis'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}]",,0.060328,Metformin did not impact insulin suppression of endogenous glucose release (P = 0.12).,"[{'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Cree-Green', 'Affiliation': 'Division of Pediatric Endocrinology, Department of Pediatrics, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Bryan C', 'Initials': 'BC', 'LastName': 'Bergman', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Eda', 'Initials': 'E', 'LastName': 'Cengiz', 'Affiliation': 'Yale School of Medicine University, New Haven, Connecticut.'}, {'ForeName': 'Larry A', 'Initials': 'LA', 'LastName': 'Fox', 'Affiliation': ""Nemours Children's Specialty Care, Jacksonville, Florida.""}, {'ForeName': 'Tamara S', 'Initials': 'TS', 'LastName': 'Hannon', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetology, Department of Pediatrics, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Kellee', 'Initials': 'K', 'LastName': 'Miller', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Nathan', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pyle', 'Affiliation': 'Department of Pediatrics, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Darcy', 'Initials': 'D', 'LastName': 'Kahn', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tansey', 'Affiliation': 'Stead Family Department of Pediatrics, Endocrinology and Diabetes, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Tichy', 'Affiliation': 'Yale School of Medicine University, New Haven, Connecticut.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Tsalikian', 'Affiliation': 'Stead Family Department of Pediatrics, Endocrinology and Diabetes, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Libman', 'Affiliation': ""Children's Hospital of Pittsburgh at University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Kristen J', 'Initials': 'KJ', 'LastName': 'Nadeau', 'Affiliation': 'Division of Pediatric Endocrinology, Department of Pediatrics, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00129']
653,32232781,Longitudinal resident coaching in the outpatient setting: A novel intervention to improve ambulatory consultation skills.,"BACKGROUND


Direct observation with feedback to learners should be a mainstay in resident education, yet it is infrequently done and its impact on consultation skills has rarely been assessed.
APPROACH


This project presents the framework and implementation of a longitudinal low-frequency, high-intensity direct observation and coaching intervention, and elaborates on insights learned. Internal medicine interns at one residency training program were randomized to an ambulatory coaching intervention or usual precepting. Over one year, coached interns had three complete primary care visits directly observed by a faculty clinician-coach who provided feedback informed by a behavior checklist. Immediately after each of the coached patient encounters, interns completed a structured self-assessment and coaches led a 30-minute feedback session informed by intern self-reflection and checklist items. Interns with usual precepting had two mini-CEX observations over the course of the year without other formal direct observation in the ambulatory setting.
EVALUATION


As part of the post-intervention assessment, senior faculty members blinded to intervention and control group assignments evaluated videotaped encounters. Coached interns completed an average of 21/23 behaviors from the checklist, while interns from the control group completed 18 (p < 0.05). The median overall grade for coached interns was B+, compared to B-/C+ for controls (p < 0.05).
REFLECTION


Coaching interns longitudinally using a behavior checklist is feasible and associated with improved consultation performance. Direct observation of complete clinical encounters followed by systematic coaching is educationally valuable, but time and resource intensive.",2020,"Coached interns completed an average of 21/23 behaviors from the checklist, while interns from the control group completed 18 (p < 0.05).",['Internal medicine interns at one residency training program'],['ambulatory coaching intervention or usual precepting'],['median overall grade'],"[{'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C0035182', 'cui_str': 'Residency'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]",,0.0156887,"Coached interns completed an average of 21/23 behaviors from the checklist, while interns from the control group completed 18 (p < 0.05).","[{'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Graddy', 'Affiliation': 'Division of Addiction Medicine, Department of Medicine, Johns Hopkins Bayview Medical Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA. ryan.graddy@gmail.com.'}, {'ForeName': 'Stasia S', 'Initials': 'SS', 'LastName': 'Reynolds', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins Bayview Medical Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Wright', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins Bayview Medical Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}]",Perspectives on medical education,['10.1007/s40037-020-00573-5']
654,31969366,Mixed methods pilot study of a low-carbohydrate diabetes prevention programme among adults with pre-diabetes in the USA.,"OBJECTIVES


(1) To estimate weight change from a low-carbohydrate diabetes prevention programme (LC-DPP) and (2) to evaluate the feasibility and acceptability of an LC-DPP.
RESEARCH DESIGN


Single-arm, mixed methods (ie, integration of quantitative and qualitative data) pilot study.
SETTING


Primary care clinic within a large academic medical centre in the USA.
PARTICIPANTS


Adults with pre-diabetes and Body Mass Index of ≥25 kg/m 2 .
INTERVENTION


We adapted the Centers for Disease Control and Prevention's National Diabetes Prevention Program (NDPP)-an evidence-based, low-fat dietary intervention-to teach participants to follow a very low-carbohydrate diet (VLCD). Participants attended 23 group-based classes over 1 year.
OUTCOME MEASURES


Primary outcome measures were (1) weight change and (2) percentage of participants who achieved ≥5% wt loss. Secondary outcome measures included intervention feasibility and acceptability (eg, attendance and qualitative interview feedback).
RESULTS


Our enrolment target was 22. One person dropped out before a baseline weight was obtained; data from 21 individuals were analysed. Mean weight loss in kilogram was 4.3 (SD 4.8) at 6 months and 4.9 (SD 5.8) at 12 months. Mean per cent body weight changes were 4.5 (SD 5.0) at 6 months and 5.2 (SD 6.0) at 12 months; 8/21 individuals (38%) achieved ≥5% wt loss at 12 months. Mean attendance was 10.3/16 weekly sessions and 3.4/7 biweekly or monthly sessions. Among interviewees (n=14), three factors facilitated VLCD adherence: (1) enjoyment of low-carbohydrate foods, (2) diminished hunger and cravings and (3) health benefits beyond weight loss. Three factors hindered VLCD adherence: (1) enjoyment of high-carbohydrate foods, (2) lack of social support and (3) difficulty preplanning meals.
CONCLUSIONS


An LC-DPP is feasible, acceptable and may be an effective option to help individuals with pre-diabetes to lose weight. Data from this pilot will be used to plan a fully powered randomised controlled trial of weight loss among NDPP versus LC-DPP participants.
TRIAL REGISTRATION NUMBER


NCT03258918.",2020,Mean per cent body weight changes were 4.5 (SD 5.0) at 6 months and 5.2 (SD 6.0) at 12 months; 8/21 individuals (38%) achieved ≥5% wt loss at 12 months.,"['Adults with pre-diabetes and Body Mass Index of ≥25', 'Primary care clinic within a large academic medical centre in the USA', 'Participants attended 23 group-based classes over 1\u2009year', 'adults with pre-diabetes in the USA']","['low-carbohydrate diabetes prevention programme (LC-DPP', 'low-carbohydrate diabetes prevention programme', 'NDPP']","['weight change and (2) percentage of participants who achieved ≥5%\u2009wt loss', 'intervention feasibility and acceptability (eg, attendance and qualitative interview feedback', 'VLCD adherence: (1) enjoyment of high-carbohydrate foods, (2) lack of social support and (3) difficulty preplanning meals', 'Mean weight loss in kilogram', 'Mean attendance', 'Mean per\u2009cent body weight changes', 'VLCD adherence: (1) enjoyment of low-carbohydrate foods, (2) diminished hunger and cravings and (3) health benefits beyond weight loss']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C0073445', 'cui_str': 'beta-N,N-dimethyl-4-nitropropiophenone'}]","[{'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0453803', 'cui_str': 'High carbohydrate food (substance)'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0037438'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0562018', 'cui_str': 'cent (qualifier value)'}, {'cui': 'C0453804', 'cui_str': 'Low carbohydrate food (substance)'}, {'cui': 'C0205216', 'cui_str': 'Decreased (qualifier value)'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0086387', 'cui_str': 'Health Benefits'}]",21.0,0.100156,Mean per cent body weight changes were 4.5 (SD 5.0) at 6 months and 5.2 (SD 6.0) at 12 months; 8/21 individuals (38%) achieved ≥5% wt loss at 12 months.,"[{'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Hafez Griauzde', 'Affiliation': 'Department of Internal Medicine, VA Ann Arbor Healthcare System, Ann Arbor, Michigan, USA dhafez@med.umich.edu.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Saslow', 'Affiliation': 'University of Michigan School of Nursing, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'Patterson', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Tahoora', 'Initials': 'T', 'LastName': 'Ansari', 'Affiliation': 'University of Michigan School of Public Health, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Liestenfeltz', 'Affiliation': 'University of Michigan School of Nursing, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Tisack', 'Affiliation': 'Wayne State University School of Medicine, Detroit, Michigan, USA.'}, {'ForeName': 'Patti', 'Initials': 'P', 'LastName': 'Bihn', 'Affiliation': 'National Kidney Foundation of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Shopinski', 'Affiliation': 'National Kidney Foundation of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Caroline R', 'Initials': 'CR', 'LastName': 'Richardson', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, Michigan, USA.'}]",BMJ open,['10.1136/bmjopen-2019-033397']
655,31982494,Financial Incentives for Smoking Cessation in Hospitalized Patients: A Randomized Clinical Trial.,"BACKGROUND


Financial incentives for smoking cessation and use of evidence-based therapy may increase quitting rates and reduce health and economic disparities.
METHODS


We randomized a low-income population of 182 hospitalized patients (mean age 58 years, 45% with high school education or less) to enhanced usual care, which included hospital-directed cessation care and Quitline referral or enhanced usual care plus financial incentives. All patients received enhanced usual care, while participants randomized to the financial incentives group were also eligible to receive up to $550 for participation in Quitline counseling ($50), participation in a community-based cessation program ($50), use of pharmacotherapy ($50), and biochemically confirmed smoking cessation at 2 months ($150) and 6 months ($250). Primary outcome was biochemically confirmed smoking cessation at 6 months after hospital discharge.
RESULTS


Total mean payment was $84 (standard deviation [SD] = $133) in the incentive group. The 6-month rate of biochemically confirmed smoking cessation was 19.6% in the incentive group and 8.9% in the enhanced usual care group (odds ratio [OR] 2.56; 95% confidence interval [CI] 0.84 to 7.83, P = 0.10). Participants in the incentive group had higher rates of nicotine replacement therapy use (57.3% vs 31.3%, P = 0.002). Financial incentives did not improve subjective social status but did increase financial stress.
CONCLUSIONS


Rates of bioconfirmed smoking cessation were higher among hospitalized patients randomized to financial incentives compared to usual care alone, but the difference was not significant. Considering the frequency of low payouts and the importance of assistance for successful quitting, future studies should explore the effectiveness of financial incentives sufficiently large to overcome barriers to evidence-based therapy.",2020,"Participants in the incentive group had higher rates of nicotine replacement therapy use (57.3% versus 31.3%, P=0.002).","['Hospitalized Patients', '182 hospitalized patients (mean age 58 years, 45% with high school education or less) to enhanced usual care, which included hospital-directed cessation care and Quitline referral, or enhanced usual care plus financial incentives']","['financial incentives group were also eligible to receive up to $550 for participation in Quitline counseling ($50), participation in a community-based cessation program ($50), use of pharmacotherapy ($50), and biochemically-confirmed smoking cessation']","['6-month rate of biochemically-confirmed smoking cessation', 'higher rates of nicotine replacement therapy use', 'subjective social status', 'financial stress', 'biochemically-confirmed smoking cessation at 6 months after hospital discharge']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3844103', 'cui_str': '550 (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0699806', 'cui_str': 'Social status'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]",182.0,0.123893,"Participants in the incentive group had higher rates of nicotine replacement therapy use (57.3% versus 31.3%, P=0.002).","[{'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Ladapo', 'Affiliation': 'Division of General Internal Medicine and Health Services Research, David Geffen School of Medicine at University of California, Los Angeles; Department of Population Health, New York University School of Medicine, New York. Electronic address: jladapo@mednet.ucla.edu.'}, {'ForeName': 'Chi-Hong', 'Initials': 'CH', 'LastName': 'Tseng', 'Affiliation': 'Division of General Internal Medicine and Health Services Research, David Geffen School of Medicine at University of California, Los Angeles.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Sherman', 'Affiliation': 'Department of Population Health, New York University School of Medicine, New York; Department of Medicine, VA New York Harbor Healthcare System, New York; Department of Medicine, New York University School of Medicine, New York.'}]",The American journal of medicine,['10.1016/j.amjmed.2019.12.025']
656,32182387,Adapalene gel 0.1% vs ketoconazole cream 2% and their combination in treatment of pityriasis versicolor: A randomized clinical study.,"Pityriasis versicolor (PV) is a chronic superficial fungal infection. Management using azole drugs leads to drug resistance. The present study aimed to compare the clinical outcome of 0.1% adapalene gel vs 2% ketoconazole cream and their combination in PV. This randomized double-blinded study was conducted on 90 PV patients divided into three equal groups. GI was treated with topical ketoconazole 2% cream twice daily and placebo, GII was treated with topical 0.1% adapalene gel twice daily and placebo and GIII was treated with topical combination of 0.1% adapalene gel (at night) and ketoconazole 2% cream (in the morning). All patients received medications for 4 weeks. Evaluation was done at 2 and 4 weeks and included clinical assessment, laboratory assessment, and patient satisfaction. We found that after 4 weeks of treatment, all groups showed significant improvement. There was better response in GIII in terms of lower rate of positive potassium hydroxide staining, higher rate of significantly improved cases and higher rate of well-satisfied patients. However, the difference fell short of statistical significance. We concluded that a combination of adapalene gel and ketoconazole cream is very effective in treatment of PV with no or mild side effects.",2020,"There was better response in GIII in terms of lower rate of positive KOH staining, higher rate of significantly improved cases and higher rate of well-satisfied patients.","['Pityriasis Versicolor', '90 PV patients divided into three equal groups', 'Pityriasis versicolor (PV']","['Adapalene Gel', 'topical 0.1% adapalene gel twice daily and placebo', 'ketoconazole 2% cream', 'topical ketoconazole', 'adapalene gel and ketoconazole cream', 'adapalene gel', 'ketoconazole cream', 'topical combination of 0.1% adapalene gel', 'Ketoconazole Cream']",[],"[{'cui': 'C0040262', 'cui_str': 'Pityriasis Versicolor'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0165631', 'cui_str': 'adapalene'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022625', 'cui_str': 'Ketoconazole'}, {'cui': 'C1378128', 'cui_str': 'Cream'}]",[],90.0,0.0623252,"There was better response in GIII in terms of lower rate of positive KOH staining, higher rate of significantly improved cases and higher rate of well-satisfied patients.","[{'ForeName': 'Essam', 'Initials': 'E', 'LastName': 'Bakr', 'Affiliation': 'Department of Dermatology and Venerology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Abdo', 'Affiliation': 'Department of Dermatology and Venerology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Abd-Elaziz', 'Affiliation': 'Department of Dermatology and Venerology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Hazem', 'Initials': 'H', 'LastName': 'Abd-Elrazek', 'Affiliation': 'Department of Dermatology and Venerology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Amer', 'Affiliation': 'Department of Dermatology and Venerology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt.'}]",Dermatologic therapy,['10.1111/dth.13319']
657,32184252,"Linking Human Milk Oligosaccharides, Infant Fecal Community Types, and Later Risk To Require Antibiotics.","Human milk oligosaccharides (HMOs) may provide health benefits to infants partly by shaping the development of the early-life intestinal microbiota. In a randomized double-blinded controlled multicentric clinical trial, healthy term infants received either infant formula (control) or the same formula with two HMOs (2'-fucosyllactose and lacto-N- neo tetraose; test) from enrollment (0 to 14 days) to 6 months. Then, all infants received the same follow-up formula without HMOs until 12 months of age. Breastfed infants (BF) served as a reference group. Stool microbiota at 3 and 12 months, analyzed by 16S rRNA gene sequencing, clustered into seven fecal community types (FCTs) with marked differences in total microbial abundances. Three of the four 12-month FCTs were likely precursors of the adult enterotypes. At 3 months, microbiota composition in the test group ( n  = 58) appeared closer to that of BF ( n  = 35) than control ( n  = 63) by microbiota alpha (within group) and beta (between groups) diversity analyses and distribution of FCTs. While bifidobacteriaceae dominated two FCTs, its abundance was significantly higher in one (FCT BiH for  Bifidobacteriaceae  at high abundance) than in the other (FCT Bi for  Bifidobacteriaceae ). HMO supplementation increased the number of infants with FCT BiH (predominant in BF) at the expense of FCT Bi (predominant in control). We explored the association of the FCTs with reported morbidities and medication use up to 12 months. Formula-fed infants with FCT BiH at 3 months were significantly less likely to require antibiotics during the first year than those with FCT Bi. Previously reported lower rates of infection-related medication use with HMOs may therefore be linked to gut microbiota community types. (This study has been registered at ClinicalTrials.gov under registration number NCT01715246.) IMPORTANCE  Human milk is the sole and recommended nutrition for the newborn infant and contains one of the largest constituents of diverse oligosaccharides, dubbed human milk oligosaccharides (HMOs). Preclinical and clinical association studies indicate that HMOs have multiple physiological functions largely mediated through the establishment of the gut microbiome. Until recently, HMOs were not available to investigate their role in randomized controlled intervention trials. To our knowledge, this is the first report on the effects of 2 HMOs on establishing microbiota in newborn infants. We provide a detailed description of the microbiota changes observed upon feeding a formula with 2 HMOs in comparison to breastfed reference infants' microbiota. Then, we associate the microbiota to long-term health as assessed by prescribed antibiotic use.",2020,Formula-fed infants with FCT BiH at 3 months were significantly less likely to require antibiotics during the first year than those with FCT Bi.,['newborn infants'],"['HMO supplementation', 'Human milk oligosaccharides (HMOs', ""infant formula (control) or the same formula with two HMOs (2'-fucosyllactose and lacto-N- neo tetraose""]","['microbiota composition', 'Stool microbiota', 'total microbial abundances', 'number of infants with FCT BiH (predominant in BF']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}]","[{'cui': 'C0018720', 'cui_str': 'Prepaid Group Health Organizations'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharides'}, {'cui': 'C0150589', 'cui_str': 'Baby Formula'}, {'cui': 'C0045214', 'cui_str': ""2'-fucosyllactose""}]","[{'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",,0.0533519,Formula-fed infants with FCT BiH at 3 months were significantly less likely to require antibiotics during the first year than those with FCT Bi.,"[{'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Berger', 'Affiliation': 'Department of Gastro-Intestinal Health, Nestlé Institute of Health Sciences, Nestlé Research, Société des Produits Nestlé SA, Lausanne, Switzerland bernard.berger@rdls.nestle.com.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Porta', 'Affiliation': 'Department of Gastro-Intestinal Health, Nestlé Institute of Health Sciences, Nestlé Research, Société des Produits Nestlé SA, Lausanne, Switzerland.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Foata', 'Affiliation': 'Department of Gastro-Intestinal Health, Nestlé Institute of Health Sciences, Nestlé Research, Société des Produits Nestlé SA, Lausanne, Switzerland.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Grathwohl', 'Affiliation': 'Clinical Development Research Unit, Nestlé Research, Société des Produits Nestlé SA, Lausanne, Switzerland.'}, {'ForeName': 'Michèle', 'Initials': 'M', 'LastName': 'Delley', 'Affiliation': 'Department of Gastro-Intestinal Health, Nestlé Institute of Health Sciences, Nestlé Research, Société des Produits Nestlé SA, Lausanne, Switzerland.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Moine', 'Affiliation': 'Department of Analytical Sciences, Institute of Food Safety & Analytical Sciences, Nestlé Research, Société des Produits Nestlé SA, Lausanne, Switzerland.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Charpagne', 'Affiliation': 'Department of Analytical Sciences, Institute of Food Safety & Analytical Sciences, Nestlé Research, Société des Produits Nestlé SA, Lausanne, Switzerland.'}, {'ForeName': 'Léa', 'Initials': 'L', 'LastName': 'Siegwald', 'Affiliation': 'Department of Gastro-Intestinal Health, Nestlé Institute of Health Sciences, Nestlé Research, Société des Produits Nestlé SA, Lausanne, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Descombes', 'Affiliation': 'Department of Analytical Sciences, Institute of Food Safety & Analytical Sciences, Nestlé Research, Société des Produits Nestlé SA, Lausanne, Switzerland.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Alliet', 'Affiliation': 'Jessa Hospital, Department of Paediatrics, Hasselt, Belgium.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Puccio', 'Affiliation': 'Dipartimento Materno Infantile AOUP Paolo Giaccone, Università di Palermo, Palermo, Italy.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Steenhout', 'Affiliation': 'Nestlé Nutrition R&D, Vevey, Switzerland.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Mercenier', 'Affiliation': 'Department of Gastro-Intestinal Health, Nestlé Institute of Health Sciences, Nestlé Research, Société des Produits Nestlé SA, Lausanne, Switzerland.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Sprenger', 'Affiliation': 'Department of Gastro-Intestinal Health, Nestlé Institute of Health Sciences, Nestlé Research, Société des Produits Nestlé SA, Lausanne, Switzerland.'}]",mBio,['10.1128/mBio.03196-19']
658,31455897,"Body weight, body composition and survival after 1 year: follow-up of a nutritional intervention trial in allo-HSCT recipients.","The role of body weight change in survival among recipients of hematopoietic stem-cell transplantation is controversial. We assessed the effect of optimizing energy and protein intake on 1-year survival, body weight and body composition, and the effect of body weight and body composition on 1-year survival in 117 patients (57 intervention, 60 control) in a randomized controlled trial. Cox regression was used to study effects of the intervention, weight and body composition on death, relapse, and nonrelapse mortality (NRM). We found no significant effect of intervention versus control on death hazard ratio (HR) 1.05, 95% confidence interval (CI) 0.54-2.04, p = 0.88), relapse (HR 1.15, 95% CI 0.48-2.27, p = 0.75), and NRM (HR 0.95, 95% CI 0.39-2.28, p = 0.90). Body weight, fat-free mass index, body fat mass index and total body water changed over time (p < 0.001), similarly in both groups (0.17 ≤ p ≤ 0.98). In multivariable analyses adjusted for group, gender and age, HRs and 95% CIs per one kilo increase in weight were 1.03 (1.01-1.06) and 1.04 (1.01-1.08) for death and NRM after 1 year (p ≤ 0.02), respectively, and 1.08 (1.01-1.15) for relapse after 3 months (p = 0.02). In conclusion, weight gain is possibly due to fluid retention and is an indicator of a complication in HSCT, rather than a marker of improved nutritional status.",2019,"We found no significant effect of intervention versus control on death hazard ratio (HR) 1.05, 95% confidence interval (CI) 0.54-2.04, p = 0.88), relapse (HR 1.15, 95% CI 0.48-2.27, p = 0.75), and NRM (HR 0.95, 95% CI 0.39-2.28, p = 0.90).","['allo-HSCT recipients', '117 patients (57 intervention, 60 control', 'recipients of hematopoietic stem-cell transplantation']",['optimizing energy and protein intake'],"['Body weight, body composition and survival', 'relapse', 'weight and body composition on death, relapse, and nonrelapse mortality (NRM', 'weight', 'Body weight, fat-free mass index, body fat mass index and total body water changed over time', 'weight gain', 'death and NRM', 'death hazard ratio', '1-year survival, body weight and body composition']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0429632', 'cui_str': 'Total body water (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",117.0,0.156154,"We found no significant effect of intervention versus control on death hazard ratio (HR) 1.05, 95% confidence interval (CI) 0.54-2.04, p = 0.88), relapse (HR 1.15, 95% CI 0.48-2.27, p = 0.75), and NRM (HR 0.95, 95% CI 0.39-2.28, p = 0.90).","[{'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'Skaarud', 'Affiliation': 'Department of Haematology, Oslo University Hospital, Oslo, Norway. kskaarud@ous-hf.no.'}, {'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Veierød', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Department of Biostatistics, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lergenmuller', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Department of Biostatistics, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bye', 'Affiliation': 'European Palliative Care Research Centre, Department of Oncology, Oslo University Hospital and Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'P O', 'Initials': 'PO', 'LastName': 'Iversen', 'Affiliation': 'Department of Haematology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'G E', 'Initials': 'GE', 'LastName': 'Tjønnfjord', 'Affiliation': 'Department of Haematology, Oslo University Hospital, Oslo, Norway.'}]",Bone marrow transplantation,['10.1038/s41409-019-0638-6']
659,30851434,Trial design and methodology for a non-restricted sequential multiple assignment randomized trial to evaluate combinations of perinatal interventions to optimize women's health.,"Pre-pregnancy overweight/obesity and excessive gestational weight gain (GWG) independently predict negative maternal and child health outcomes. To date, however, interventions that target GWG have not produced lasting improvements in maternal weight or health at 12-months postpartum. Given that interventions solely aimed at addressing GWG may not equip women with the skills needed for postpartum weight management, interventions that address health behaviors over the perinatal period might maximize maternal health in the first postpartum year. Thus, the current study leveraged a sequential multiple assignment randomized trial (SMART) design to evaluate sequences of prenatal (i.e., during pregnancy) and postpartum lifestyle interventions that optimize maternal weight, cardiometabolic health, and psychosocial outcomes at 12-months postpartum. Pregnant women (N = 300; ≤16 weeks pregnant) with overweight/obesity (BMI ≥ 25 kg/m 2 ) are being recruited. Women are randomized to intervention or treatment as usual on two occasions: (1) early in pregnancy, and (2) prior to delivery, resulting in four intervention sequences. Intervention during pregnancy is designed to moderate GWG and introduce skills for management of weight as a chronic condition, while intervention in the postpartum period addresses weight loss. The primary outcome is weight at 12-months postpartum and secondary outcomes include variables of cardiometabolic health and psychosocial well-being. Analyses will evaluate the combination of prenatal and postpartum lifestyle interventions that optimizes maternal weight and secondary outcomes at 12-months postpartum. Optimizing the sequence of behavioral interventions to address specific needs during pregnancy and the first postpartum year can maximize intervention potency and mitigate longer-term cardiometabolic health risks for women.",2019,Pre-pregnancy overweight/obesity and excessive gestational weight gain (GWG) independently predict negative maternal and child health outcomes.,"[""women's health"", 'women', 'Pregnant women (N\u202f=\u202f300; ≤16\u202fweeks pregnant) with overweight/obesity (BMI\u202f≥\u202f25\u202fkg/m 2 ) are being recruited']",[],"['maternal weight, cardiometabolic health, and psychosocial outcomes', 'maternal weight or health', 'weight at 12-months postpartum and secondary outcomes include variables of cardiometabolic health and psychosocial well-being', 'Pre-pregnancy overweight/obesity and excessive gestational weight gain (GWG']","[{'cui': 'C0080339', 'cui_str': 'Womens Health'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",[],"[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}]",,0.065762,Pre-pregnancy overweight/obesity and excessive gestational weight gain (GWG) independently predict negative maternal and child health outcomes.,"[{'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Germeroth', 'Affiliation': ""Department of Psychiatry, University of Pittsburgh, 3811 O'Hara Street, Pittsburgh, PA 15213, USA.""}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Benno', 'Affiliation': ""Department of Psychiatry, University of Pittsburgh, 3811 O'Hara Street, Pittsburgh, PA 15213, USA.""}, {'ForeName': 'Rachel P', 'Initials': 'RP', 'LastName': 'Kolko Conlon', 'Affiliation': ""Department of Psychiatry, University of Pittsburgh, 3811 O'Hara Street, Pittsburgh, PA 15213, USA.""}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Emery', 'Affiliation': ""Department of Psychiatry, University of Pittsburgh, 3811 O'Hara Street, Pittsburgh, PA 15213, USA.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Statistics, University of Pittsburgh, 1800 Wesley W. Posvar Hall, 230 South Bouquet Street, Pittsburgh, PA 15260, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Grace', 'Affiliation': ""Department of Psychiatry, University of Pittsburgh, 3811 O'Hara Street, Pittsburgh, PA 15213, USA.""}, {'ForeName': 'Rachel H', 'Initials': 'RH', 'LastName': 'Salk', 'Affiliation': ""Department of Psychiatry, University of Pittsburgh, 3811 O'Hara Street, Pittsburgh, PA 15213, USA.""}, {'ForeName': 'Michele D', 'Initials': 'MD', 'LastName': 'Levine', 'Affiliation': ""Department of Psychiatry, University of Pittsburgh, 3811 O'Hara Street, Pittsburgh, PA 15213, USA. Electronic address: levinem@upmc.edu.""}]",Contemporary clinical trials,['10.1016/j.cct.2019.03.002']
660,31498264,Combined Intravenous and Intraarticular Tranexamic Acid Does Not Offer Additional Benefit Compared with Intraarticular Use Alone in Bilateral TKA: A Randomized Controlled Trial.,"BACKGROUND


Tranexamic acid (TXA) is efficacious for reducing blood loss and transfusion use in patients who undergo bilateral TKA, and it is administered intravenously alone, intraarticularly alone, or as a combination of these. However, it is unclear whether combined intravenous (IV) and intraarticular TXA offers any additional benefit over intraarticular use alone in patients undergoing bilateral TKA.
QUESTIONS/PURPOSES


The purposes of our study was to determine (1) whether combined IV and intraarticular TXA reduces blood loss and blood transfusion use compared with intraarticular use alone and (2) whether the frequency of adverse events is different between these routes of administration in patients who undergo simultaneous or staged bilateral TKA.
METHODS


Between April 2015 and May 2017, one surgeon performed 316 same-day bilateral TKAs and 314 staged bilateral TKAs. Of those, 98% of patients in each same-day TKA (310) and staged bilateral TKA (309) groups were eligible for this randomized trial and all of those patients agreed to participate and were randomized. The study included four groups: simultaneous TKA with intraarticular TXA only (n = 157), simultaneous TKA with IV and intraarticular TXA (n = 153), staged TKA with intraarticular TXA only (n = 156), and staged TKA with IV and intraarticular TXA (n = 155). There were no differences in demographic data among the intraarticular alone and IV plus intraarticular TXA groups of patients who underwent simultaneous or staged bilateral TKA in terms of age, proportion of female patients, BMI, or preoperative hematologic values. The primary outcome variables were total blood loss calculated based on patient blood volume and a drop in the hemoglobin level and administration of blood transfusion. The secondary outcomes of this study were a decrease in the postoperative hemoglobin level; the proportion of patients with a hemoglobin level lower than 7.0, 8.0, or 9.0 g/dL; and the frequencies of symptomatic deep vein thrombosis, symptomatic pulmonary embolism, wound complications, and periprosthetic joint infection.
RESULTS


Total blood loss with intraarticular TXA alone in patients undergoing simultaneous bilateral TKA and those undergoing staged procedures was not different from the total blood loss with the combined IV plus intraarticular TXA regimen (1063 mL ± 303 mL versus 1004 mL ± 287 mL, mean difference 59 mL [95% CI -7 to 125]; p = 0.08 and 909 ml ± 283 ml versus 845 ml ± 278 ml; mean difference 64 mL [95% CI 1 to 127]; p = 0.046, respectively). The use of blood transfusions between intraarticular alone and combined IV and intraarticular TXA was also not different among patients undergoing simultaneous (0% [0 of 152] versus 1%; p = 0.149) and staged TKA (1% [1 of 155] versus 0% [0 of 153]; p = 0.98). Furthermore, the frequency of symptomatic thromboembolic events, wound complications, and periprosthetic joint infections was low, without any differences among the groups with the numbers available.
CONCLUSION


Because there was no difference between intraarticular alone and combined intraarticular plus IV regimen of TXA administration, we recommend that IV and intraarticular TXA should not be used in combination. Moreover, other studies have found no differences between intraarticular and IV TXA used alone, and hence to avoid potential complications associated with systemic administration, we recommend that intraarticular alone is sufficient for routine TKA.
LEVEL OF EVIDENCE


Level I, therapeutic study.",2020,"There were no differences in demographic data among the intraarticular alone and IV plus intraarticular TXA groups of patients who underwent simultaneous or staged bilateral TKA in terms of age, proportion of female patients, BMI, or preoperative hematologic values.","['Bilateral TKA', 'patients who undergo simultaneous or staged bilateral TKA', 'patients who undergo bilateral TKA', 'patients undergoing bilateral TKA', 'Between April 2015 and May 2017']","['intraarticular TXA', 'combined intravenous (IV) and intraarticular TXA', 'combined IV and intraarticular TXA', 'staged TKA with intraarticular TXA', 'TKA with intraarticular TXA', 'Intraarticular Tranexamic Acid', 'Tranexamic acid (TXA', 'staged TKA with IV and intraarticular TXA', 'TXA administration', 'IV and intraarticular TXA', 'intraarticular alone and combined IV and intraarticular TXA', 'simultaneous TKA with IV and intraarticular TXA', 'TXA']","['demographic data', 'blood loss and blood transfusion', 'total blood loss', 'blood transfusions', 'Total blood loss', 'frequency of symptomatic thromboembolic events, wound complications, and periprosthetic joint infections', 'postoperative hemoglobin level; the proportion of patients with a hemoglobin level', 'total blood loss calculated based on patient blood volume and a drop in the hemoglobin level and administration of blood transfusion', 'frequencies of symptomatic deep vein thrombosis, symptomatic pulmonary embolism, wound complications, and periprosthetic joint infection']","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0232100', 'cui_str': 'Exsanguinating Hemorrhage'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C1096106'}, {'cui': 'C0157749', 'cui_str': 'Arthropathy associated with infection'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0005850', 'cui_str': 'Blood Volume'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}]",316.0,0.107007,"There were no differences in demographic data among the intraarticular alone and IV plus intraarticular TXA groups of patients who underwent simultaneous or staged bilateral TKA in terms of age, proportion of female patients, BMI, or preoperative hematologic values.","[{'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Meshram', 'Affiliation': 'P. Meshram, J. V. Palanisamy, J. Y. Seo, J. G. Lee, Joint Reconstruction Center, Seoul National University Bundang Hospital, Seoul, Republic of Korea T. K. Kim, Department of Orthopaedic Surgery, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jeya Venkatesh', 'Initials': 'JV', 'LastName': 'Palanisamy', 'Affiliation': ''}, {'ForeName': 'Jong Yeon', 'Initials': 'JY', 'LastName': 'Seo', 'Affiliation': ''}, {'ForeName': 'Jong Geun', 'Initials': 'JG', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Tae Kyun', 'Initials': 'TK', 'LastName': 'Kim', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000000942']
661,32232481,Prognostic value of interim FDG-PET in diffuse large cell lymphoma: results from the CALGB 50303 Clinical Trial.,"As part of a randomized, prospective clinical trial in large cell lymphoma, we conducted serial fluorodeoxyglucose positron emission tomography (FDG-PET) at baseline, after 2 cycles of chemotherapy (interim PET [i-PET]), and at end of treatment (EoT) to identify biomarkers of response that are predictive of remission and survival. Scans were interpreted in a core laboratory by 2 imaging experts, using the visual Deauville 5-point scale (5-PS), and by calculating percent change in FDG uptake (change in standardized uptake value [ΔSUV]). Visual scores of 1 through 3 and ΔSUV ≥66% were prospectively defined as negative. Of 524 patients enrolled in the parent trial, 169 agreed to enroll in the PET substudy and 158 were eligible for final analysis. In this selected population, all had FDG-avid disease at baseline; by 5-PS, 55 (35%) remained positive on i-PET and 28 (18%) on EoT PET. Median ΔSUV on i-PET was 86.2%. With a median follow-up of 5 years, ΔSUV, as continuous variable, was associated with progression-free survival (PFS) (hazard ratio [HR] = 0.99; 95% confidence interval [CI], 0.97-1.00; P = .02) and overall survival (OS) (HR, 0.98; 95% CI, 0.97-0.99; P = .03). ΔSUV ≥66% was predictive of OS (HR, 0.31; 95% CI, 0.11-0.85; P = .02) but not PFS (HR, 0.47; 95% CI, 0.19-1.13; P = .09). Visual 5-PS on i-PET did not predict outcome. ΔSUV, but not visual analysis, on i-PET predicted OS in DLBCL, although the low number of events limited the statistical analysis. These data may help guide future clinical trials using PET response-adapted therapy. This trial was registered at www.clinicaltrials.gov as #NCT00118209.",2020,Visual 5-PS on i-PET did not predict outcome.,"['Large Cell Lymphoma', '524 patients enrolled in the parent trial, 169 agreed to enroll in the PET substudy and 158 were eligible for final analysis']",[],"['predictive of OS', 'overall survival (OS', 'FDG uptake (ΔSUV', 'Median ΔSUV', 'Visual scores', 'visual 5-point scale (5-PS', 'progression-free survival (PFS']","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",524.0,0.472593,Visual 5-PS on i-PET did not predict outcome.,"[{'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Schöder', 'Affiliation': 'Department Radiology, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Mei-Yin C', 'Initials': 'MC', 'LastName': 'Polley', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Knopp', 'Affiliation': 'Department Radiology, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Hall', 'Affiliation': 'Department Radiology, Philadelphia VA Medical Center, Philadelphia, PA.'}, {'ForeName': 'Lale', 'Initials': 'L', 'LastName': 'Kostakoglu', 'Affiliation': 'Department Radiology, Mt. Sinai Medical Center, New York, NY.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department Radiology, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Howard R', 'Initials': 'HR', 'LastName': 'Higley', 'Affiliation': 'CCS Associates, Inc., San Jose, CA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Kelloff', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Rockville, MD.'}, {'ForeName': 'Heshan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Zelenetz', 'Affiliation': 'Department Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Cheson', 'Affiliation': 'Department Medicine, MedStar Georgetown University Hospital, Washington, DC.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Wagner-Johnston', 'Affiliation': 'Department Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Brad S', 'Initials': 'BS', 'LastName': 'Kahl', 'Affiliation': 'Department Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Friedberg', 'Affiliation': 'Department Medicine, University of Rochester Medical Center, Rochester, NY.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Hsi', 'Affiliation': 'Department Laboratory Medicine, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Leonard', 'Affiliation': 'Department Medicine, Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Lawrence H', 'Initials': 'LH', 'LastName': 'Schwartz', 'Affiliation': 'Department Radiology, Columbia University Medical Center, New York, NY; and.'}, {'ForeName': 'Wyndham H', 'Initials': 'WH', 'LastName': 'Wilson', 'Affiliation': 'Lymphoid Malignancies Branch, National Cancer Institute, National Institutes of Health, Rockville, MD.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Bartlett', 'Affiliation': 'Department Medicine, Washington University School of Medicine, St. Louis, MO.'}]",Blood,['10.1182/blood.2019003277']
662,30825525,Solving insomnia electronically: Sleep treatment for asthma (SIESTA): A study protocol for a randomized controlled trial.,"BACKGROUND


Chronic insomnia is associated with poor asthma control. Cognitive-behavioral treatment for insomnia (CBT-I) is an efficacious and durable treatment for comorbid insomnia in medical and psychiatric disorders. However, the efficacy and potential accompanying mechanisms of CBT-I have not been examined in asthma. The purpose of this study is to test the efficacy of a CBT-I intervention on sleep and asthma control in adults with insomnia and asthma. We will also explore airway inflammation (i.e., exhaled nitric oxide, blood eosinophils) as a potential biological mechanism linking improvements in sleep with improvements in asthma control.
METHODS


The study is a single center, parallel group, randomized controlled trial. Two hundred and ten adults with insomnia and asthma that is not well-controlled will be randomized to either a 9-week Internet-based CBT-I program (Sleep Healthy Using the Internet (SHUTi)) or an enhanced usual care condition which utilizes an online educational video about insomnia. The primary sleep outcome is insomnia severity measured by the Insomnia Severity Index. Secondary sleep outcomes are sleep quality and wrist actigraph-recorded sleep parameters. Asthma control will be assessed by the Asthma Control Test, Asthma Quality of Life Questionnaire, pulmonary function testing, and self-report of asthma exacerbations and asthma-related healthcare utilization. Treatment outcomes will be measured at baseline, 9 weeks, and 6 months.
DISCUSSION


This trial has the potential to identify a novel strategy for improving asthma control. Findings may advocate for the inclusion of treatment of comorbid insomnia into current asthma management practice guidelines.",2019,Cognitive-behavioral treatment for insomnia (CBT-I) is an efficacious and durable treatment for comorbid insomnia in medical and psychiatric disorders.,"['adults with insomnia and asthma', 'Two hundred and ten adults with insomnia and asthma that is not well-controlled', 'asthma (SIESTA']","['Cognitive-behavioral treatment', 'CBT-I intervention', 'Sleep Healthy Using the Internet (SHUTi)) or an enhanced usual care condition which utilizes an online educational video about insomnia', '9-week Internet-based CBT-I program ']","['sleep quality and wrist actigraph-recorded sleep parameters', 'Asthma Control Test, Asthma Quality of Life Questionnaire, pulmonary function testing, and self-report of asthma exacerbations and asthma-related healthcare utilization', 'insomnia severity measured by the Insomnia Severity Index']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test (assessment scale)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}]",210.0,0.0541839,Cognitive-behavioral treatment for insomnia (CBT-I) is an efficacious and durable treatment for comorbid insomnia in medical and psychiatric disorders.,"[{'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': 'School of Nursing, University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Buysse', 'Affiliation': 'Department of Psychiatry and Clinical and Translational Science, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Ritterband', 'Affiliation': 'Center for Behavioral Health & Technology, Department of Psychiatry and Neurobehavioral Sciences, University of Virginia School of Medicine, Charlottesville, VA, United States of America.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Sereika', 'Affiliation': 'School of Nursing, University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Strollo', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States of America; VA Pittsburgh Healthcare System, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Sally E', 'Initials': 'SE', 'LastName': 'Wenzel', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Faith S', 'Initials': 'FS', 'LastName': 'Luyster', 'Affiliation': 'School of Nursing, University of Pittsburgh, Pittsburgh, PA, United States of America. Electronic address: luysterfs@upmc.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.02.011']
663,31051322,Trajectories of change in maternal and adolescent depressive symptoms in the depression prevention initiative.,"BACKGROUND


Given the prevalence and consequences of adolescent depression, depression prevention has become an important area of research. While prevention programs like Interpersonal Psychotherapy - Adolescent Skills Training (IPT-AST) have demonstrated effectiveness, little research to date has studied the relationship between maternal depression and adolescent outcomes in these programs.
METHOD


The current study investigated the relationship between maternal and adolescent depressive symptoms in 167 mother-adolescent dyads who were enrolled in the Depression Prevention Initiative (DPI), a randomized controlled trial that compared IPT-AST to group counseling (GC). First, the study examined the relationship between initial levels of adolescent and maternal depressive symptoms. The study then investigated whether maternal depressive symptoms improved over the two-year study period. Finally, the study assessed whether maternal and adolescent symptoms changed concurrently across time.
RESULTS


Results indicated that initial levels of maternal and adolescent symptoms were positively associated. Additionally, maternal symptoms improved across the two-year period. Maternal and adolescent outcomes were related across time: as adolescents improved in our study, their mothers also improved.
LIMITATIONS


The study utilized self-report data only and did not allow for the testing of causality in the relationship between mother-youth depression.
CONCLUSIONS


These findings add to the literature demonstrating that as one part of the mother-child dyad improves, the other improves as well. These findings extend the current understanding of the relationship between maternal and adolescent depressive symptom outcomes, and have important implications for the prevention and treatment of depression.",2019,"While prevention programs like Interpersonal Psychotherapy - Adolescent Skills Training (IPT-AST) have demonstrated effectiveness, little research to date has studied the relationship between maternal depression and adolescent outcomes in these programs.
",['167 mother-adolescent dyads who were enrolled in the Depression Prevention Initiative (DPI'],"['IPT-AST to group counseling (GC', 'Interpersonal Psychotherapy - Adolescent Skills Training (IPT-AST']","['maternal and adolescent symptoms', 'Maternal and adolescent outcomes', 'initial levels of maternal and adolescent symptoms', 'maternal symptoms', 'maternal depressive symptoms', 'initial levels of adolescent and maternal depressive symptoms']","[{'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}]","[{'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0237547', 'cui_str': 'Group counseling (procedure)'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy (regime/therapy)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",,0.0341619,"While prevention programs like Interpersonal Psychotherapy - Adolescent Skills Training (IPT-AST) have demonstrated effectiveness, little research to date has studied the relationship between maternal depression and adolescent outcomes in these programs.
","[{'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Spiro-Levitt', 'Affiliation': ""Department of Child and Adolescent Psychiatry, Hassenfeld Children's Hospital at New York University Langone, United States. Electronic address: carolyn.spiro@nyulangone.org.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gallop', 'Affiliation': 'Department of Mathematics, West Chester University, United States.'}, {'ForeName': 'Jami F', 'Initials': 'JF', 'LastName': 'Young', 'Affiliation': ""Department of Child and Adolescent Psychiatry and Behavioral Sciences, Children's Hospital of Philadelphia, United States; Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, United States.""}]",Journal of affective disorders,['10.1016/j.jad.2019.04.089']
664,30950637,"Piloting a Sequential, Multiple Assignment, Randomized Trial for Mothers with Attention-Deficit/Hyperactivity Disorder and Their At-Risk Young Children.","Objective:  Parental attention-deficit/hyperactivity disorder (ADHD) is associated with suboptimal parenting and reduces the effectiveness of child ADHD treatments. We conducted a Pilot Sequential, Multiple Assignment, Randomized Trial (SMART Pilot) to evaluate the feasibility and acceptability of sequencing medication and behavioral treatments for mothers with ADHD to target outcomes, including maternal ADHD, parenting, and child ADHD symptoms/impairment in multiplex ADHD families.  Methods:  Thirty-five mothers with ADHD and their 5- to 8-year-old child with ADHD symptoms were enrolled. Mothers were randomized to 8 weeks of individually titrated stimulant medication (MSM) or behavioral parent training (BPT), followed by rerandomization to 8 weeks of continued first-line treatment (with as-needed modifications) or combined treatment, leading to four treatment sequences (MSM-MSM, MSM-BPT, BPT-MSM, and BPT-BPT).  Results:  Recruitment of multiplex ADHD families came primarily from child providers. Mothers were adherent to medication and had high therapy session attendance. Mothers and clinicians found both treatments to be acceptable and preferred combination treatment, especially receiving medication before BPT. Monotherapy treatment visits were viewed as more burdensome (MSM-MSM, BPT-BPT).  Conclusions:  Maternal stimulant medication and BPT are acceptable and feasible interventions for families in which both the mother and child have ADHD symptoms. Mothers with concerns about their children's ADHD symptoms are receptive to receiving treatment themselves as an initial strategy for improving their children's health and functioning. Fully powered SMART designs show promise in evaluating the sequencing of interventions and helping clinicians develop algorithms for treating multiplex families in real-world practice settings.",2019,"Mothers were randomized to 8 weeks of individually titrated stimulant medication (MSM) or behavioral parent training (BPT), followed by rerandomization to 8 weeks of continued first-line treatment (with as-needed modifications) or combined treatment, leading to four treatment sequences (MSM-MSM, MSM-BPT, BPT-MSM, and BPT-BPT).  ","['Mothers with Attention-Deficit/Hyperactivity Disorder and Their At-Risk Young Children', ""Mothers with concerns about their children's ADHD symptoms"", 'mothers with ADHD to target outcomes, including maternal ADHD, parenting, and child ADHD symptoms/impairment in multiplex ADHD families', 'Thirty-five mothers with ADHD and their 5- to 8-year-old child with ADHD symptoms were enrolled']","['Maternal stimulant medication and BPT', 'individually titrated stimulant medication (MSM) or behavioral parent training (BPT), followed by rerandomization to 8 weeks of continued first-line treatment (with as-needed modifications) or combined treatment, leading to four treatment sequences (MSM-MSM, MSM-BPT, BPT-MSM, and BPT-BPT', 'Parental attention-deficit/hyperactivity disorder (ADHD', 'sequencing medication and behavioral treatments']",[],"[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}]",[],35.0,0.0259498,"Mothers were randomized to 8 weeks of individually titrated stimulant medication (MSM) or behavioral parent training (BPT), followed by rerandomization to 8 weeks of continued first-line treatment (with as-needed modifications) or combined treatment, leading to four treatment sequences (MSM-MSM, MSM-BPT, BPT-MSM, and BPT-BPT).  ","[{'ForeName': 'Erin N', 'Initials': 'EN', 'LastName': 'Schoenfelder', 'Affiliation': '1 Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, Washington.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Chronis-Tuscano', 'Affiliation': '3 Department of Psychology, University of Maryland, College Park, Maryland.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Strickland', 'Affiliation': ""2 Center for Child Health, Behavior and Development, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Almirall', 'Affiliation': '4 Department of Statistics, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Stein', 'Affiliation': '1 Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, Washington.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2018.0136']
665,30393015,Pulmonary and other health effects of electronic cigarette use among adult smokers participating in a randomized controlled smoking reduction trial.,"BACKGROUND


There is limited evidence about the effects of dual electronic cigarette (e-cig) and combustible cigarette use on lung health or other health outcomes. Studies that have evaluated these outcomes have not included estimates of e-cig or cigarette exposure in the analyses.
MATERIALS AND METHODS


Data analyzed were from 263 smokers participating in a randomized controlled trial designed to encourage participants to reduce their combustible cigarette use by substituting with an e-cig or a non-electronic cigarette substitute (cig-sub). t-tests were used to evaluate changes from baseline at 1 month and 3 months in lung function, blood pressure, pulse, exhaled carbon monoxide, and weight. Linear mixed effects models were used to test associations between health outcomes and study product group, including exposure to the study products (e-cig and cig-sub times used and days used in the past 7 days) and cigarettes per day (CPD).
RESULTS


There were few significant differences between the groups for lung function indices at any time point in the unadjusted analyses. There were significant reductions in diastolic blood pressure and pulse at 1 month in the unadjusted analyses for those in the e-cig group compared to the cig-sub group. CPD decreased significantly more for the e-cig group than for the cig-sub group at both time points. There were no significant associations between any measured health outcomes and group in the linear mixed effects models.
CONCLUSION


E-cig use did not contribute to significant changes in health outcome markers as compared with use of a non-electronic cig-sub.",2019,CPD decreased significantly more for the e-cig group than for the cig-sub group at both time points.,"['Data analyzed were from 263 smokers participating', 'adult smokers participating']","['electronic cigarette', 'dual electronic cigarette', 'combustible cigarette use by substituting with an e-cig or a non-electronic cigarette substitute (cig-sub']","['CPD', 'diastolic blood pressure and pulse', 'lung function indices', 'lung function, blood pressure, pulse, exhaled carbon monoxide, and weight']","[{'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C1273517', 'cui_str': 'Used by'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}]","[{'cui': 'C2001794', 'cui_str': '(BMIM)(TFSI) cpd'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",263.0,0.0349599,CPD decreased significantly more for the e-cig group than for the cig-sub group at both time points.,"[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Veldheer', 'Affiliation': 'Penn State University, Department of Public Health Sciences, Tobacco Center of Regulatory Science, College of Medicine, 500 University Dr., Hershey, PA 17033, United States. Electronic address: sveldheer@psu.edu.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Yingst', 'Affiliation': 'Penn State University, Department of Public Health Sciences, Tobacco Center of Regulatory Science, College of Medicine, 500 University Dr., Hershey, PA 17033, United States.'}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Midya', 'Affiliation': 'Penn State University, Department of Public Health Sciences, Tobacco Center of Regulatory Science, College of Medicine, 500 University Dr., Hershey, PA 17033, United States.'}, {'ForeName': 'Breianna', 'Initials': 'B', 'LastName': 'Hummer', 'Affiliation': 'Penn State University, Department of Public Health Sciences, Tobacco Center of Regulatory Science, College of Medicine, 500 University Dr., Hershey, PA 17033, United States.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Lester', 'Affiliation': 'Penn State University, Department of Public Health Sciences, Tobacco Center of Regulatory Science, College of Medicine, 500 University Dr., Hershey, PA 17033, United States.'}, {'ForeName': 'Nicolle', 'Initials': 'N', 'LastName': 'Krebs', 'Affiliation': 'Penn State University, Department of Public Health Sciences, Tobacco Center of Regulatory Science, College of Medicine, 500 University Dr., Hershey, PA 17033, United States.'}, {'ForeName': 'Shari', 'Initials': 'S', 'LastName': 'Hrabovsky', 'Affiliation': 'Penn State University, Department of Public Health Sciences, Tobacco Center of Regulatory Science, College of Medicine, 500 University Dr., Hershey, PA 17033, United States.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Wilhelm', 'Affiliation': 'Penn State University, Department of Public Health Sciences, Tobacco Center of Regulatory Science, College of Medicine, 500 University Dr., Hershey, PA 17033, United States.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Penn State University, Department of Public Health Sciences, Tobacco Center of Regulatory Science, College of Medicine, 500 University Dr., Hershey, PA 17033, United States.'}, {'ForeName': 'Miao-Shan', 'Initials': 'MS', 'LastName': 'Yen', 'Affiliation': 'Virginia Commonwealth University, Center for the Study of Tobacco Products, 1112 East Clay St., Richmond, VA 23298, United States.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Cobb', 'Affiliation': 'Virginia Commonwealth University, Center for the Study of Tobacco Products, 1112 East Clay St., Richmond, VA 23298, United States.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Eissenberg', 'Affiliation': 'Virginia Commonwealth University, Center for the Study of Tobacco Products, 1112 East Clay St., Richmond, VA 23298, United States.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Foulds', 'Affiliation': 'Penn State University, Department of Public Health Sciences, Tobacco Center of Regulatory Science, College of Medicine, 500 University Dr., Hershey, PA 17033, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2018.10.041']
666,30664943,Design of a randomized trial testing a multi-level weight-control intervention to reduce obesity and related health conditions in low-income workers.,"Weight-control is a major public health focus for preventing multiple obesity-related health conditions. While clinic-based intensive lifestyle interventions are successful, low-socioeconomic-status (SES) populations, which have a higher burden of obesity, are difficult to reach; thus, the workplace offers a useful setting to target low-SES workers. The current paper presents the design of a study testing a workplace intervention aimed at low-SES employees. Partnering with a large healthcare system and affiliated university, this project will test an innovative multi-level intervention (""Working for You"") adapted from existing group- and individual-level intervention models to promote healthy weight among low-wage workers. The individual-level component is an interactive obesity treatment approach (iOTA) program that involves assessment of behavior risks, collaborative goal-setting with a health coach, and interactive SMS text-messages for ongoing support and self-monitoring. This mHealth intervention is embedded in the group-level component, a workplace participatory program that involves worker teams engaged in the design and implementation of interventions to change their workplace environments. These nested interventions are being tested in a group-randomized trial among 22 work groups (~1000 total workers, ~300 workers with obesity). The primary outcome will be program effects on weight at 2-year follow-up, compared to control, and the secondary outcomes will be effects on diet and physical activity; iOTA adherence, process measures, and work environment/support will also be examined. This pragmatic clinical trial will test scalable interventions that can be translated to other work settings to reduce obesity and related health risks among low-SES workers. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02934113.",2019,"This mHealth intervention is embedded in the group-level component, a workplace participatory program that involves worker teams engaged in the design and implementation of interventions to change their workplace environments.","['22 work groups (~1000 total workers, ~300 workers with obesity', 'low-income workers']","['multi-level weight-control intervention', 'innovative multi-level intervention (""Working for You"") adapted from existing group- and individual-level intervention models']","['diet and physical activity; iOTA adherence, process measures, and work environment/support will also be examined', 'program effects on weight at 2-year follow-up']","[{'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0302604', 'cui_str': 'Low income'}]","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen (regime/therapy)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0443009', 'cui_str': 'Iota'}, {'cui': 'C0086850', 'cui_str': 'Process Measures'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",,0.0419941,"This mHealth intervention is embedded in the group-level component, a workplace participatory program that involves worker teams engaged in the design and implementation of interventions to change their workplace environments.","[{'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Stein', 'Affiliation': 'Washington University School of Medicine, Department of Medicine, Division of Geriatrics and Nutritional Science, 660 S. Euclid, Campus Box 8083, St. Louis, MO 63110, United States. Electronic address: rstein@wustl.edu.'}, {'ForeName': 'Jaime R', 'Initials': 'JR', 'LastName': 'Strickland', 'Affiliation': 'Washington University School of Medicine, Department of Medicine, Division of Geriatrics and Nutritional Science, 660 S. Euclid, Campus Box 8083, St. Louis, MO 63110, United States.'}, {'ForeName': 'Rachel G', 'Initials': 'RG', 'LastName': 'Tabak', 'Affiliation': 'Washington University School of Medicine, Department of Medicine, Division of Geriatrics and Nutritional Science, 660 S. Euclid, Campus Box 8083, St. Louis, MO 63110, United States.'}, {'ForeName': 'Ann Marie', 'Initials': 'AM', 'LastName': 'Dale', 'Affiliation': 'Washington University School of Medicine, Department of Medicine, Division of Geriatrics and Nutritional Science, 660 S. Euclid, Campus Box 8083, St. Louis, MO 63110, United States.'}, {'ForeName': 'Graham A', 'Initials': 'GA', 'LastName': 'Colditz', 'Affiliation': 'Washington University School of Medicine, Department of Medicine, Division of Geriatrics and Nutritional Science, 660 S. Euclid, Campus Box 8083, St. Louis, MO 63110, United States.'}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Evanoff', 'Affiliation': 'Washington University School of Medicine, Department of Medicine, Division of Geriatrics and Nutritional Science, 660 S. Euclid, Campus Box 8083, St. Louis, MO 63110, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.01.011']
667,32227432,Empagliflozin reduces the risk of mortality and hospitalization for heart failure across Thrombolysis In Myocardial Infarction Risk Score for Heart Failure in Diabetes categories: Post hoc analysis of the EMPA-REG OUTCOME trial.,"AIM


To investigate the association of the Thrombolysis In Myocardial Infarction (TIMI) Risk Score for Heart Failure in Diabetes (TRS-HF DM  ) with mortality using data from the EMPA-REG OUTCOME trial.
MATERIALS AND METHODS


In EMPA-REG OUTCOME, patients with type 2 diabetes and atherosclerotic cardiovascular (CV) disease (N = 7020) received the sodium-glucose co-transporter-2 inhibitor, empagliflozin, 10 or 25 mg or placebo. Post hoc, patients were stratified into risk categories (low-intermediate, high, very-high risk scores) using baseline TRS-HF DM  . Cox regression analyses evaluated the association of TRS-HF DM  categories with all-cause mortality (ACM), CV death, hospitalization for heart failure (HHF) and CV death (excluding fatal stroke) or HHF, and whether empagliflozin reduced the risk of CV outcomes across these risk categories.
RESULTS


In placebo patients, increasing risk category was associated with a higher risk of ACM, CV death, and HHF. Empagliflozin reduced the risk of ACM (low-intermediate HR 0.68 [95% CI 0.48, 0.97] and very-high 0.69 [0.52, 0.91]), CV death (0.75 [0.48, 1.18] and 0.56 [0.41, 0.78]), HHF (0.53 [0.28, 1.01] and 0.67 [0.48, 0.96]), and CV death or HHF (0.69 [0.46, 1.03]) and (0.64 [0.49, 0.82]) across all risk categories versus placebo. Higher absolute risk reductions (ARRs) were observed for CV death in the very-high versus low-intermediate category (P = 0.01).
CONCLUSIONS


Applied to EMPA-REG OUTCOME, higher TRS-HF DM  was associated with increased HHF and mortality risk. Empagliflozin reduced CV outcomes across TRS-HF DM  categories. Higher ARRs were associated with higher risk scores.",2020,"Higher absolute risk reductions (ARRs) were observed for CV death in the very-high versus low-intermediate category (P = 0.01).
","['patients with type 2 diabetes and atherosclerotic cardiovascular (CV) disease (N = 7020', 'Heart Failure in Diabetes categories', 'Diabetes']","['Empagliflozin', 'placebo', 'Thrombolysis', 'sodium-glucose co-transporter-2 inhibitor, empagliflozin, 10 or 25\u2009mg or placebo', 'empagliflozin']","['risk of CV outcomes', 'CV death', 'HHF and mortality risk', 'Myocardial Infarction (TIMI', 'HHF', 'higher risk of ACM, CV death, and HHF', 'risk of mortality and hospitalization for heart failure across Thrombolysis', 'CV death or HHF', 'TRS-HF DM  categories with all-cause mortality (ACM), CV death, hospitalization for heart failure (HHF) and CV death (excluding fatal stroke) or HHF', 'risk of ACM', 'Higher absolute risk reductions (ARRs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}]",,0.169317,"Higher absolute risk reductions (ARRs) were observed for CV death in the very-high versus low-intermediate category (P = 0.01).
","[{'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Abhinav', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'McGill University Health Centre, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Anne Pernille', 'Initials': 'AP', 'LastName': 'Ofstad', 'Affiliation': 'Boehringer Ingelheim Norway KS, Asker, Norway.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fitchett', 'Affiliation': ""Division of Cardiology, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brueckmann', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Würzburg University Clinic, Würzburg, Germany.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Zwiener', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.'}, {'ForeName': 'Jyothis T', 'Initials': 'JT', 'LastName': 'George', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson, Mississippi.'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Mazer', 'Affiliation': ""Department of Anesthesia, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}]","Diabetes, obesity & metabolism",['10.1111/dom.14015']
668,30571923,Physical Function Trajectories in Survivors of Acute Respiratory Failure.,"RATIONALE


Survivorship from critical illness has improved; however, factors mediating the functional recovery of persons experiencing a critical illness remain incompletely understood.
OBJECTIVES


To identify groups of acute respiratory failure (ARF) survivors with similar patterns of physical function recovery after discharge and to determine the characteristics associated with group membership in each physical function trajectory group.
METHODS


We performed a secondary analysis of a randomized controlled trial, using group-based trajectory modeling to identify distinct subgroups of patients with similar physical function recovery patterns after ARF. Chi-square tests and one-way analysis of variance were used to determine which variables were associated with trajectory membership. A multinomial logistic regression analysis was performed to identify variables jointly associated with trajectory group membership.
RESULTS


A total of 260 patients enrolled in a trial evaluating standardized rehabilitation therapy in patients with ARF and discharged alive (NCT00976833) were included in this analysis. Physical function was quantified using the Short Physical Performance Battery at hospital discharge and 2, 4, and 6 months after enrollment. Latent class analysis of the Short Physical Performance Battery scores identified four trajectory groups. These groups differ in both the degree and rate of physical function recovery. A multinomial logistic regression analysis was performed using covariates that have been previously identified in the literature as influencing recovery after critical illness. By multinomial logistic regression, age (P < 0.001), female sex (P = 0.001), intensive care unit (ICU) length of stay (LOS) (P = 0.003), and continuous intravenous sedation days (P = 0.004) were the variables that jointly influenced trajectory group membership. Participants in the trajectory demonstrating most rapid and complete functional recovery consisted of younger females with fewer continuous sedation days and a shorter LOS. The participant trajectory that failed to functionally recover consisted of older patients with greater sedation time and the longest LOS.
CONCLUSIONS


We identified distinct trajectories of physical function recovery after critical illness. Age, sex, continuous sedation time, and ICU length of stay impact the trajectory of functional recovery after critical illness. Further examination of these groups may assist in clinical trial design to tailor interventions to specific subgroups.",2019,"Physical function was quantified using the Short Physical Performance Battery at hospital discharge and 2, 4, and 6 months after enrollment.","['older patients with greater sedation time and the longest LOS', 'patients with similar physical function recovery patterns after ARF', 'Survivors of Acute Respiratory Failure', '260 patients enrolled in a trial evaluating standardized rehabilitation therapy in patients with ARF and discharged alive (NCT00976833']",[],"['Physical Function Trajectories', 'Physical function', 'intensive care unit (ICU) length of stay (LOS']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure (disorder)'}, {'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C2584946', 'cui_str': 'Alive'}]",[],"[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",260.0,0.122077,"Physical function was quantified using the Short Physical Performance Battery at hospital discharge and 2, 4, and 6 months after enrollment.","[{'ForeName': 'Sheetal', 'Initials': 'S', 'LastName': 'Gandotra', 'Affiliation': '1 Pulmonary, Allergy, and Critical Care Medicine, University of Alabama, Birmingham, Alabama.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Lovato', 'Affiliation': '2 Department of Biostatistical Sciences.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Case', 'Affiliation': '2 Department of Biostatistical Sciences.'}, {'ForeName': 'Rita N', 'Initials': 'RN', 'LastName': 'Bakhru', 'Affiliation': '3 Pulmonary, Critical Care, Allergy, and Immunologic Disease.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Gibbs', 'Affiliation': '3 Pulmonary, Critical Care, Allergy, and Immunologic Disease.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Berry', 'Affiliation': '5 Department of Health and Exercise Science, Wake Forest University, Winston-Salem, North Carolina; and.'}, {'ForeName': 'D Clark', 'Initials': 'DC', 'LastName': 'Files', 'Affiliation': '3 Pulmonary, Critical Care, Allergy, and Immunologic Disease.'}, {'ForeName': 'Peter E', 'Initials': 'PE', 'LastName': 'Morris', 'Affiliation': '6 Division of Pulmonary, Critical Care, and Sleep Medicine, University of Kentucky, Lexington, Kentucky.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201806-375OC']
669,32223442,Using the theory of self-affirmation and self-regulation strategies of mental contrasting and forming implementation intentions to reduce social anxiety symptoms.,"Background and Objectives:  Based on the results of past research on emotion regulation and positive behavioral change via self-affirmation, it was hypothesized that self-affirmation should help socially anxious individuals to reduce social anxiety symptoms. The effectiveness of a brief self-affirmation intervention framed in terms of implementation intentions (if-then plans with self-affirming cognitions) was compared against forming non-affirming implementation intentions (with distraction as a way of coping) and inactive control condition. Additionally, it was tested whether mental contrasting can augment the impact of the self-affirmation intervention.  Design/Methods:  Participants ( N  = 198, aged 18-45) were randomly assigned to one of three intervention conditions (self-affirming implementation intention, mental contrasting with self-affirming implementation intention, or non-affirming implementation intention) or an inactive control-group. Social anxiety symptoms were assessed at baseline and at one-week post-intervention.  Results:  The difference between the interventions and the control group was substantial. However, there were no differences in the reduction of overall social anxiety levels between the interventions. Each of the interventions produced a statistically significant reduction in social anxiety (Cohen's  d s from -.40 to -.50).  Conclusions:  The results indicate no advantage for self-affirming over non-affirming implementation intentions in reducing social anxiety symptoms. Moreover, no superiority of mental contrasting was found.",2020,Each of the interventions produced a statistically significant reduction in social anxiety (Cohen's  d s from -.40 to -.50).,"['Participants ( N \u2009=\u2009198, aged 18-45']","['intervention conditions (self-affirming implementation intention, mental contrasting with self-affirming implementation intention, or non-affirming implementation intention) or an inactive control-group']","['overall social anxiety levels', 'Social anxiety symptoms', 'social anxiety symptoms', 'social anxiety']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0424166', 'cui_str': 'Social Anxiety'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0206555,Each of the interventions produced a statistically significant reduction in social anxiety (Cohen's  d s from -.40 to -.50).,"[{'ForeName': 'Patryk', 'Initials': 'P', 'LastName': 'Łakuta', 'Affiliation': 'Department of Psychology, SWPS University of Social Sciences and Humanities, Warsaw, Poland.'}]","Anxiety, stress, and coping",['10.1080/10615806.2020.1746283']
670,32224978,Evaluating Activation and Absence of Negative Effect: Gamification and Escape Rooms for Learning.,"Innovation has allowed for and developed new ways of teaching and learning. Gamification is among the new training methodologies, which is a didactic approach based on the game structure with an attractive component for students. Within gamification, flipped learning and problem-based learning, escape rooms can be found as a technical aspect, which is focused on providing enigmas and tracks for the various educational content that students have assimilated through learning based on problem solving. The aim of this study is to identify how the use of gamification with the use of educational escape rooms affects activation and absence of a negative effect on students. 61 Master students of the Autonomous City of Ceuta participated in this case study. They were divided into three study groups (1 control group; 2 experimental groups) that followed different formative actions (control group-traditional; experimental groups-escape rooms). To achieve the objectives, a mixed research design based on quantitative and qualitative techniques was followed. The instrument used for data collection was the GAMEX (Gameful Experience Scale). The results reveal that the students who had taken a gamified formative action through escape rooms obtained better assessment results in the indicators concerning motivation, teamwork, commitment, activation, and absence of a negative effect on the learning process than those with the traditional methodology.",2020,"The results reveal that the students who had taken a gamified formative action through escape rooms obtained better assessment results in the indicators concerning motivation, teamwork, commitment, activation, and absence of a negative effect on the learning process than those with the traditional methodology.","['61 Master students of the Autonomous City of Ceuta participated in this case study', 'students']",['formative actions (control group-traditional; experimental groups-escape rooms'],[],"[{'cui': 'C0444649', 'cui_str': 'Master (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0085973', 'cui_str': 'Case Study'}]","[{'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],61.0,0.0123796,"The results reveal that the students who had taken a gamified formative action through escape rooms obtained better assessment results in the indicators concerning motivation, teamwork, commitment, activation, and absence of a negative effect on the learning process than those with the traditional methodology.","[{'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'López-Belmonte', 'Affiliation': 'Department of Didactics and School Organization, University of Granada, 18071 Granada, Spain.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Segura-Robles', 'Affiliation': 'Department of Research Methods and Diagnosis in Education, University of Granada, 18071 Granada, Spain.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Fuentes-Cabrera', 'Affiliation': 'Department of Didactics and School Organization, University of Granada, 18071 Granada, Spain.'}, {'ForeName': 'María Elena', 'Initials': 'ME', 'LastName': 'Parra-González', 'Affiliation': 'Department of Research Methods and Diagnosis in Education, University of Granada, 18071 Granada, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17072224']
671,32224536,The clinical study of en bloc transurethral resection with 980 nm laser for treatment of primary non-muscle invasive bladder cancer.,"OBJECTIVE


To elevate safety and efficacy of en bloc transurethral resection with 980 nm laser as treatment for primary non-muscle-invasive bladder cancer (NMIBC).
METHODS


Total 84 cases were enrolled in this study. Among them, 36 and 48 cases underwent treatment using the 980 nm laser and the traditional TUR-BT procedure, respectively. The peri-operative characteristics (tumor size, tumor multiplicity, tumor grade, etc.) and intra-operative complications (obturator nerve reflex, bladder perforation, bladder irrigation, etc.) were recorded and compared between the two groups.
RESULTS


There are no significant difference in baseline characteristics between laser and TUR-Bt treatment groups. Operation time also has no significant difference in two groups. Obturator nerve reflex and bladder perforation were noted in 6 patients and in 3 patients during TUR-Bt group, respectively. No obturator nerve reflex and bladder perforation were observed in the laser group. The patients who need bladder irrigation was lower in laser group than in TUR-Bt group. There were no significant differences in catheterization time and hospitalization time between two groups. No significant difference in the overall recurrence rate were observed among the two groups during the follow-up periods.
CONCLUSION


En bloc transurethral resection using 980 nm laser is an effective and safe treatment option for non-muscle-invasive bladder cancer. Compared to the traditional TUR-Bt procedure, the procedure using 980 nm laser has fewer perioperative complications and similar oncological results.",2020,"Obturator nerve reflex and bladder perforation were noted in 6 patients and in 3 patients during TUR-Bt group, respectively.","['primary non-muscle-invasive bladder cancer (NMIBC', 'non-muscle-invasive bladder cancer', 'primary non-muscle invasive bladder cancer', 'Total 84 cases were enrolled in this study']","['en bloc transurethral resection with 980\u200anm laser', 'En bloc transurethral resection using 980\u200anm laser', 'en Bloc transurethral resection with 980\u200anm Laser']","['Operation time', 'overall recurrence rate', 'Obturator nerve reflex and bladder perforation', 'obturator nerve reflex and bladder perforation', 'catheterization time and hospitalization time', 'perioperative complications', 'peri-operative characteristics (tumor size, tumor multiplicity, tumor grade, etc.) and intra-operative complications (obturator nerve reflex, bladder perforation, bladder irrigation, etc', 'need bladder irrigation']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}]","[{'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0028783', 'cui_str': 'Obturator Nerve'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0434133', 'cui_str': 'Perforation of bladder (disorder)'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0449822', 'cui_str': 'Multiplicity (attribute)'}, {'cui': 'C3179006', 'cui_str': 'Tumor Grading'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0194423', 'cui_str': 'Bladder irrigation'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]",84.0,0.0163352,"Obturator nerve reflex and bladder perforation were noted in 6 patients and in 3 patients during TUR-Bt group, respectively.","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Tao', 'Affiliation': 'Department of Urology, the Second Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Chuanyang', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': 'Department of Urology, the Second Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Qiu', 'Initials': 'Q', 'LastName': 'Yao', 'Affiliation': 'Department of Urology, the Second Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Fu', 'Affiliation': 'Department of Urology, the Second Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Yuxi', 'Initials': 'Y', 'LastName': 'Shan', 'Affiliation': 'Department of Urology, the Second Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Institute for Regenerative Medicine, Wake Forest University, Winston-Salem, NC, USA.'}, {'ForeName': 'Boxin', 'Initials': 'B', 'LastName': 'Xue', 'Affiliation': 'Department of Urology, the Second Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Dongrong', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, the Second Affiliated Hospital of Soochow University, Suzhou, China.'}]",Journal of X-ray science and technology,['10.3233/XST-190616']
672,30772471,Design and baseline characteristics of a low-income urban cohort of children with asthma: The Asthma Action at Erie Trial.,"OBJECTIVE


To describe the methodology of a randomized controlled trial comparing the efficacy of integrated asthma community health workers (CHW) and a certified asthma educator (AE-C) to improve asthma outcomes in low-income minority children in Chicago.
METHODS


Child/caregiver dyads were randomized to CHW home visits or education in the clinic from an AE-C. Intervention was delivered in the first year after enrollment. Data collection occured at baseline, 6-, 12-, 18, and 24-months. The co-primary outcomes included asthma control using the Asthma Control Test/childhood Asthma Control Test (ACT/cACT) and activity limitation over the past 14 days.
RESULTS


A total of 223 participants ages 5-16 years were randomized. The majority of children were in the 5-11 year old range (78.9%). Most caregivers (96.9%) and 44% of children were female. Approximately 85% of caregivers and children reported Hispanic ethnicity and 62.3% reported a household income of ≤ $59,000. Over half (55.7%) had uncontrolled asthma as measured by ACT/cACT; 13.9% had a normal ACT/cACT score but were uncontrolled using the Asthma Control Questionnaire and 20.2% were controlled on both measures but had received oral steroids in the past year for asthma.
CONCLUSION


The Asthma Action at Erie Trial successfully recruited a largely Hispanic cohort of children with uncontrolled or high-risk asthma to study the differential effects of clinic-based AE-C and home-based CHW interventions. Strengths of the trial include its comparative effectivness design that integrates interventionists and intervention delivery into a clinical setting. Categorizing asthma control in community settings for research purposes presents unique challenges.
CLINICAL TRIAL REGISTRATION


University of Illinois at Chicago Protocol Record R01HL123797, Asthma Action at Erie TrialClinicalTrials.gov Identifier: NCT02481986 ""ClinicalTrials.gov Registration"" register@clinicaltrials.gov.",2019,"Over half (55.7%) had uncontrolled asthma as measured by ACT/cACT; 13.9% had a normal ACT/cACT score but were uncontrolled using the Asthma Control Questionnaire and 20.2% were controlled on both measures but had received oral steroids in the past year for asthma.
","['low-income urban cohort of children with asthma', 'low-income minority children in Chicago', 'Child/caregiver dyads', 'largely Hispanic cohort of children with uncontrolled or high-risk asthma', '223 participants ages 5-16\u202fyears']","['oral steroids', 'integrated asthma community health workers (CHW) and a certified asthma educator (AE-C', 'CHW home visits or education in the clinic from an AE-C. Intervention']","['normal ACT/cACT score', 'Hispanic ethnicity', 'asthma control using the Asthma Control Test/childhood Asthma Control Test (ACT/cACT) and activity limitation over the past 14\u202fdays']","[{'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1264638', 'cui_str': 'Catalytic activity'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test (assessment scale)'}, {'cui': 'C0264408', 'cui_str': 'Childhood asthma (disorder)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",223.0,0.163321,"Over half (55.7%) had uncontrolled asthma as measured by ACT/cACT; 13.9% had a normal ACT/cACT score but were uncontrolled using the Asthma Control Questionnaire and 20.2% were controlled on both measures but had received oral steroids in the past year for asthma.
","[{'ForeName': 'Giselle S', 'Initials': 'GS', 'LastName': 'Mosnaim', 'Affiliation': 'NorthShore University HealthSystem, University of Illinois at Chicago, United States. Electronic address: gmosnaim@northshore.org.'}, {'ForeName': 'Sally M', 'Initials': 'SM', 'LastName': 'Weinstein', 'Affiliation': 'NorthShore University HealthSystem, University of Illinois at Chicago, United States.'}, {'ForeName': 'Oksana', 'Initials': 'O', 'LastName': 'Pugach', 'Affiliation': 'NorthShore University HealthSystem, University of Illinois at Chicago, United States.'}, {'ForeName': 'Genesis', 'Initials': 'G', 'LastName': 'Rosales', 'Affiliation': 'NorthShore University HealthSystem, University of Illinois at Chicago, United States.'}, {'ForeName': 'Angkana', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': 'NorthShore University HealthSystem, University of Illinois at Chicago, United States.'}, {'ForeName': 'Surrey', 'Initials': 'S', 'LastName': 'Walton', 'Affiliation': 'NorthShore University HealthSystem, University of Illinois at Chicago, United States.'}, {'ForeName': 'Molly A', 'Initials': 'MA', 'LastName': 'Martin', 'Affiliation': 'NorthShore University HealthSystem, University of Illinois at Chicago, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.02.006']
673,32225027,Effectiveness of a Multifactorial Intervention in the First 1000 Days of Life to Prevent Obesity and Overweight in Childhood: Study Protocol.,"(1)  Background : Obesity is a global health problem, and its prevention must be a priority goal of public health, especially considering the seriousness of the problem among children. It is known that fetal and early postnatal environments may favor the appearance of obesity in later life. In recent years, the impact of the programs to prevent obesity in childhood has been scarce. The aim of this research is to evaluate the effectiveness of an intervention based on the concept of early programming. (2)  Methods : Non-randomized controlled trial design. Inclusion criteria are: two-year-old infants whose gestational period begins in the 14 months following the start of the intervention, and whose mothers have made the complete follow-up of their pregnancy in the same clinical unit of the study. The intervention will be developed over all the known factors that affect early programming, during pregnancy up to 2 years of life. Data will be collected through a data collection sheet by the paediatricians. A unibivariate and multivariate analysis of the data will be carried out. (3)  Ethics and dissemination : The trial does not involve any risk to participants and their offspring. Signed informed consent is obtained from all participants. Ethical approval has been obtained. (4)  Results : It is expected that this study will provide evidence on the importance of the prevention of obesity from the critical period of the first 1000 days of life, being able to establish this as a standard intervention in primary care.",2020,"The intervention will be developed over all the known factors that affect early programming, during pregnancy up to 2 years of life.","['Obesity and Overweight in Childhood', 'Inclusion criteria are: two-year-old infants whose gestational period begins in the 14 months following the start of the intervention, and whose mothers have made the complete follow-up of their pregnancy in the same clinical unit of the study']",['Multifactorial Intervention'],[],"[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4521075', 'cui_str': 'Childhood Overweight'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],[],,0.0447759,"The intervention will be developed over all the known factors that affect early programming, during pregnancy up to 2 years of life.","[{'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Díaz-Rodríguez', 'Affiliation': 'Department of Nursing and Physiotherapy, University of Cádiz, 11009 Andalusia, Spain.'}, {'ForeName': 'Celia', 'Initials': 'C', 'LastName': 'Pérez-Muñoz', 'Affiliation': 'Department of Nursing and Physiotherapy, University of Cádiz, 11009 Andalusia, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Lendínez-de la Cruz', 'Affiliation': 'Ribera del Muelle Health Centre, Clinic Management Unit (CMU) Puerto Real, Cádiz, Andalusian Health System, 11510 Andalusia, Spain.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Fernández-Gutiérrez', 'Affiliation': 'Department of Nursing and Physiotherapy, University of Cádiz, 11009 Andalusia, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Bas-Sarmiento', 'Affiliation': 'Department of Nursing and Physiotherapy, University of Cádiz, 11009 Andalusia, Spain.'}, {'ForeName': 'Bernardo C', 'Initials': 'BC', 'LastName': 'Ferriz-Mas', 'Affiliation': 'Río San Pedro Health Centre, Clinic Management Unit (CMU) Puerto Real, Cádiz, Andalusian Health System, 11519 Andalusia, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17072239']
674,32225032,The Effect of the Promotion of Vegetables by a Social Influencer on Adolescents' Subsequent Vegetable Intake: A Pilot Study.,"Marketers have found new ways of reaching adolescents on social platforms. Previous studies have shown that advertising effectively increases the intake of unhealthy foods while not so much is known about the promotion of healthier foods. Therefore, the main aim of the present experimental pilot study was to examine if promoting red peppers by a popular social influencer on social media (Instagram) increased subsequent actual vegetable intake among adolescents. We used a randomized between-subject design with 132 adolescents (age: 13-16 y). Adolescents were exposed to an Instagram post by a highly popular social influencer with vegetables (n = 44) or energy-dense snacks (n = 44) or were in the control condition (n = 44). The main outcome was vegetable intake. Results showed no effect of the popular social influencer promoting vegetables on the intake of vegetables. No moderation effects were found for parasocial interaction and persuasion knowledge. Bayesian results were consistent with the results and supported evidence against the effect of the experimental condition. Worldwide, youth do not consume the recommended amount of fruit and vegetables, making it important to examine if mere exposure or different forms of food promotion techniques for healthier foods are effective in increasing the intake of these foods.",2020,No moderation effects were found for parasocial interaction and persuasion knowledge.,"[""Adolescents' Subsequent Vegetable Intake"", '132 adolescents (age: 13-16 y', 'adolescents']","['Promotion of Vegetables by a Social Influencer', 'Instagram post by a highly popular social influencer with vegetables (n = 44) or energy-dense snacks']","['intake of vegetables', 'parasocial interaction and persuasion knowledge', 'vegetable intake']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake (observable entity)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C3494314', 'cui_str': 'Snacking'}]","[{'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0031230', 'cui_str': 'Persuasion'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake (observable entity)'}]",132.0,0.0251539,No moderation effects were found for parasocial interaction and persuasion knowledge.,"[{'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Folkvord', 'Affiliation': 'Open Evidence Research, Barcelona, 08018 Barcelona, Spain.'}, {'ForeName': 'Manouk', 'Initials': 'M', 'LastName': 'de Bruijne', 'Affiliation': 'Independent Researcher, De Boelelaan 1101, 1081 HV Amsterdam, The Netherlands.'}]",International journal of environmental research and public health,['10.3390/ijerph17072243']
675,30797042,A randomized controlled trial of buprenorphine for probationers and parolees: Bridging the gap into treatment.,"BACKGROUND


Buprenorphine can be effective in a variety of community substance use treatment settings outside of methadone programs, including outpatient programs and medical practices. In these settings, it has been found to be effective in reducing opioid use and retaining patients in treatment. Despite its effectiveness and safety, it is rarely provided to individuals with opioid use disorders in probation and parole settings.
METHODS


Male and female individuals under probation or parole supervision (N = 320) with histories of opioid use disorder will be enrolled in this randomized controlled trial. Participants will be randomized to one of two study arms: Buprenorphine Bridge Treatment (BBT): Participants will begin buprenorphine using the MedicaSafe dispensing device immediately after an on-site intake at a community supervision office and continue such treatment until they are transitioned to a community program; or Treatment as Usual (TAU): Participants will receive a referral to buprenorphine pharmacotherapy treatment in the community. Treatment outcomes will be: (a) illicit opioid oral saliva drug test results; and (b) treatment adherence (i. entered community based treatment; ii. number of days receiving opioid treatment).
RESULTS


We describe the background and rationale for the study, its aims, hypotheses, and study design.
CONCLUSIONS


If shown to increase compliance rates with conditions of probation and parole, buprenorphine treatment co-located at community supervision field offices could have a major impact on delivery of buprenorphine treatment to the criminal justice population. The public health impact of the proposed study would be widespread because this intervention could be implemented throughout areas of the US.",2019,"CONCLUSIONS


If shown to increase compliance rates with conditions of probation and parole, buprenorphine treatment co-located at community supervision field offices could have a major impact on delivery of buprenorphine treatment to the criminal justice population.","['Male and female individuals under probation or parole supervision (N\u202f=\u202f320) with histories of opioid use disorder', 'individuals with opioid use disorders in probation and parole settings']","['Buprenorphine Bridge Treatment (BBT', 'Buprenorphine', 'buprenorphine pharmacotherapy treatment', 'buprenorphine']",['illicit opioid oral saliva drug test results; and (b) treatment adherence (i. entered community based treatment; ii. number of days receiving opioid treatment'],"[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C4517711', 'cui_str': '320 (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0456378', 'cui_str': 'Type of bridge (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0332266', 'cui_str': 'Illicit (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4505265', 'cui_str': 'Treatment Adherence'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",320.0,0.0672827,"CONCLUSIONS


If shown to increase compliance rates with conditions of probation and parole, buprenorphine treatment co-located at community supervision field offices could have a major impact on delivery of buprenorphine treatment to the criminal justice population.","[{'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Gordon', 'Affiliation': 'Friends Research Institute, Baltimore, MD, USA. Electronic address: mgordon@friendsresearch.org.'}, {'ForeName': 'Frank J', 'Initials': 'FJ', 'LastName': 'Vocci', 'Affiliation': 'Friends Research Institute, Baltimore, MD, USA.'}, {'ForeName': 'Faye', 'Initials': 'F', 'LastName': 'Taxman', 'Affiliation': 'Department of Criminology, Law & Society, George Mason University, Fairfax, VA, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Fishman', 'Affiliation': 'Mountain Manor Treatment Center, Baltimore, MD, USA.'}, {'ForeName': 'Bikash', 'Initials': 'B', 'LastName': 'Sharma', 'Affiliation': 'Mountain Manor Treatment Center, Baltimore, MD, USA.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Blue', 'Affiliation': 'Department of Criminology, Law & Society, George Mason University, Fairfax, VA, USA.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': ""O'Grady"", 'Affiliation': 'Department of Psychology, University of Maryland, College Park, MD, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.02.009']
676,32224987,Psychological and Sleep Effects of Tryptophan and Magnesium-Enriched Mediterranean Diet in Women with Fibromyalgia.,"Anxiety, mood disturbance, eating and sleep disorders, and dissatisfaction with body image are prevalent disorders in women with fibromyalgia. The authors of this study aimed to determine the effects of tryptophan (TRY) and magnesium-enriched (MG) Mediterranean diet on psychological variables (trait anxiety, mood state, eating disorders, self-image perception) and sleep quality in women with fibromyalgia ( n  = 22; 49 ± 5 years old). In this randomized, controlled trial, the participants were randomly assigned to the experimental group and the placebo group. The intervention group received a Mediterranean diet enriched with high doses of TRY and MG (60 mg of TRY and 60 mg of MG), whereas the control group received the standard Mediterranean diet. Pittsburgh Sleep Quality Questionnaire, Body Shape Questionnaire, State-Trait Anxiety Inventory (STAI), Profile of Mood States (POMS-29) Questionnaire, Eating Attitudes Test-26, and Trait Anxiety Inventory were completed before and 16 weeks after the intervention. Significant differences were observed between groups after the intervention for the mean scores of trait anxiety ( p  = 0.001), self-image perception ( p  = 0.029), mood disturbance ( p  = 0.001), and eating disorders ( p  = 0.006). This study concludes that tryptophan and magnesium-enriched Mediterranean diet reduced anxiety symptoms, mood disturbance, eating disorders, and dissatisfaction with body image but did not improve sleep quality in women with fibromyalgia.",2020,"Significant differences were observed between groups after the intervention for the mean scores of trait anxiety ( p  = 0.001), self-image perception ( p  = 0.029), mood disturbance ( p  = 0.001), and eating disorders ( p  = 0.006).","['women with fibromyalgia ( n  = 22; 49 ± 5 years old', 'Women with Fibromyalgia', 'women with fibromyalgia']","['Mediterranean diet enriched with high doses of TRY and MG (60 mg of TRY and 60 mg of MG', 'standard Mediterranean diet', 'Tryptophan and Magnesium-Enriched Mediterranean Diet', 'placebo', 'tryptophan and magnesium-enriched Mediterranean diet', 'tryptophan (TRY) and magnesium-enriched (MG) Mediterranean diet']","['Anxiety, mood disturbance, eating and sleep disorders, and dissatisfaction with body image', 'mean scores of trait anxiety', 'sleep quality', 'anxiety symptoms, mood disturbance, eating disorders, and dissatisfaction with body image', 'eating disorders', 'psychological variables (trait anxiety, mood state, eating disorders, self-image perception) and sleep quality', 'Pittsburgh Sleep Quality Questionnaire, Body Shape Questionnaire, State-Trait Anxiety Inventory (STAI), Profile of Mood States (POMS-29) Questionnaire, Eating Attitudes Test-26, and Trait Anxiety Inventory', 'self-image perception', 'mood disturbance']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0041249', 'cui_str': 'L-tryptophan'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}, {'cui': 'C2732632', 'cui_str': 'Poor body image'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0242498', 'cui_str': 'Self-Perception'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451032', 'cui_str': 'Body shape questionnaire (assessment scale)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states (assessment scale)'}, {'cui': 'C0451136', 'cui_str': 'Eating attitudes test (assessment scale)'}]",,0.121059,"Significant differences were observed between groups after the intervention for the mean scores of trait anxiety ( p  = 0.001), self-image perception ( p  = 0.029), mood disturbance ( p  = 0.001), and eating disorders ( p  = 0.006).","[{'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Martínez-Rodríguez', 'Affiliation': 'Faculty of Sciences, University of Alicante, 03690 Alicante, Spain.'}, {'ForeName': 'Jacobo Á', 'Initials': 'JÁ', 'LastName': 'Rubio-Arias', 'Affiliation': 'Effort Physiology Laboratory Research Group, Department of Health and Human Performance, Faculty of Physical Activity and Sport Science-INEF, Universidad Politécnica de Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Domingo J', 'Initials': 'DJ', 'LastName': 'Ramos-Campo', 'Affiliation': 'Faculty of Sports, Catholic University of Murcia, 30107 Murcia, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Reche-García', 'Affiliation': 'Faculty of Nursing, Catholic University of Murcia, 30107 Murcia, Spain.'}, {'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Leyva-Vela', 'Affiliation': 'Department of Health, Vinalopó University Hospital, 03293 Elche, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Nadal-Nicolás', 'Affiliation': 'Faculty of Medicine, Miguel Hernández University of Elche, 03202 Elche, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17072227']
677,32050198,"Effect of Breathing Oxygen-Enriched Air on Exercise Performance in Patients with Chronic Obstructive Pulmonary Disease: Randomized, Placebo-Controlled, Cross-Over Trial.","BACKGROUND


Patients with chronic obstructive pulmonary disease (COPD) experience dyspnea and hypoxemia during exercise.
OBJECTIVE


The aim of this study was to evaluate the effects of breathing oxygen-enriched air on exercise performance and associated physiological changes in patients with COPD.
METHODS


In a randomized, placebo-controlled, single-blind, cross-over trial, 20 patients with COPD (11 women, age 65 ± 6 years, FEV1 64 ± 19% pred., resting SpO2 ≥90%) performed 4 cycle ergospirometries to exhaustion using an incremental exercise test (IET) and a constant work rate (at 75% maximal workload with air) exercise test (CWRET), each with ambient (FiO2 0.21) and oxygen-enriched (FiO2 0.5) air. The main outcomes were the change in maximal workload in the IET and the change in exercise duration in the CWRET with oxygen versus air. Electrocardiogram, pulmonary gas exchange, thoracic volumes by inductance plethysmography, arterial blood gases, and cerebral and quadriceps muscle tissue oxygenation (CTO and MTO) were additionally measured.
RESULTS


In the IET, maximal workload increased from 96 ± 21 to 104 ± 28 W with oxygen. In the CWRET, exercise duration increased from 605 ± 274 to 963 ± 444 s with oxygen. At end-exercise with oxygen, CTO, MTO, PaO2, and PaCO2 were increased, while V'E/V'CO2 was reduced and thoracic volumes were similar. At the corresponding time to end of exercise with ambient air, oxygen decreased heart rate, respiratory rate, minute ventilation, and V'E/V'CO2, while oxygenation was increased.
CONCLUSION


In COPD patients without resting hypoxemia, breathing oxygen-enriched air improves exercise performance. This relates to a higher arterial oxygen saturation promoting oxygen availability to muscle and cerebral tissue and an enhanced ventilatory efficiency. COPD patients may benefit from oxygen therapy during exercise training.",2020,"At end-exercise with oxygen, CTO, MTO, PaO2, and PaCO2 were increased, while V'E/V'CO2 was reduced and thoracic volumes were similar.","['Patients with chronic obstructive pulmonary disease (COPD) experience dyspnea and hypoxemia during exercise', 'patients with COPD', 'Patients with Chronic Obstructive Pulmonary Disease', '20 patients with COPD (11 women, age 65 ± 6 years, FEV1 64 ± 19% pred., resting SpO2 ≥90%) performed 4', 'COPD patients']","['Placebo', 'breathing oxygen-enriched air', 'placebo', 'Breathing Oxygen-Enriched Air', 'cycle ergospirometries to exhaustion using an incremental exercise test (IET) and a constant work rate (at 75% maximal workload with air) exercise test (CWRET), each with ambient (FiO2 0.21) and oxygen-enriched (FiO2 0.5) air']","['thoracic volumes', ""heart rate, respiratory rate, minute ventilation, and V'E/V'CO2, while oxygenation"", 'Exercise Performance', 'maximal workload in the IET and the change in exercise duration', 'oxygen, CTO, MTO, PaO2, and PaCO2', 'Electrocardiogram, pulmonary gas exchange, thoracic volumes by inductance plethysmography, arterial blood gases, and cerebral and quadriceps muscle tissue oxygenation (CTO and MTO', 'resting hypoxemia, breathing oxygen-enriched air improves exercise performance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0587107', 'cui_str': 'During exercise (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C4517437', 'cui_str': '0.21 (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}]","[{'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1822073', 'cui_str': 'PaO2'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0034071', 'cui_str': 'Pulmonary Gas Exchange'}, {'cui': 'C0032221', 'cui_str': 'Plethysmography'}, {'cui': 'C0150411', 'cui_str': 'Blood gases, arterial measurement (procedure)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",20.0,0.330158,"At end-exercise with oxygen, CTO, MTO, PaO2, and PaCO2 were increased, while V'E/V'CO2 was reduced and thoracic volumes were similar.","[{'ForeName': 'Elisabeth Domenica', 'Initials': 'ED', 'LastName': 'Hasler', 'Affiliation': 'Pulmonary Clinic, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Saxer', 'Affiliation': 'Pulmonary Clinic, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Simon Raphael', 'Initials': 'SR', 'LastName': 'Schneider', 'Affiliation': 'Pulmonary Clinic, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Furian', 'Affiliation': 'Pulmonary Clinic, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Lichtblau', 'Affiliation': 'Pulmonary Clinic, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Esther Irene', 'Initials': 'EI', 'LastName': 'Schwarz', 'Affiliation': 'Pulmonary Clinic, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Konrad E', 'Initials': 'KE', 'LastName': 'Bloch', 'Affiliation': 'Pulmonary Clinic, University Hospital Zurich and Centre for Integrative Human Physiology, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Ulrich', 'Affiliation': 'Pulmonary Clinic, University Hospital Zurich and Centre for Integrative Human Physiology, University of Zurich, Zurich, Switzerland, silvia.ulrich@usz.ch.'}]",Respiration; international review of thoracic diseases,['10.1159/000505819']
678,32103364,A segmentation-independent volume rendering visualisation method might reduce redundant explorations and post-surgical complications of microvascular decompression.,"OBJECTIVES


This study aimed to investigate the feasibility of segmentation-independent volume rendering (SI-VR) in visualising the root entry zone (REZ), and to explore the influence on the management of vascular compression syndromes (VCSs).
METHODS


Two hundred and twenty patients with VCSs were recruited in this prospective study from July 2015 to May 2019. SI-VR was reconstructed based on inverted 3D fast spin echo T2WI. They were assigned to the experimental group and control group randomly. Patients in the experimental group would accept extra evaluation based on SI-VR before microvascular decompression. Image quality and diagnostic accuracy between SI-VR and 3D fast spin echo T2WI in the experimental group were compared by Mann-Whitney U test and chi-square test, separately. Interobserver agreement was performed with intraclass correlation coefficient. Postsurgical outcomes and complications between two groups were compared by chi-square test.
RESULTS


SI-VR had a better interobserver agreement (0.82 vs 0.68) and diagnostic accuracy (95.5% vs 83.6%, p = 0.004) than that of 3D fast spin echo T2WI. Especially, significantly improved diagnostic accuracy was reached in detecting the multi-vascular branches compression (100% vs 15.4%, p < 0.001). There were fewer complications (7.1% vs 26.8%, p = 0.004) and less operation time (20.7 min vs 14.5 min, p = 0.007) but no significant difference of pain relief (p = 0.19) in the experimental group than in the control group.
CONCLUSIONS


The SI-VR method is feasible for the precise demonstration of the anatomy structure along the REZ, with high reliability and reproducibility. Unbiased pre-surgical visualisation could reduce redundant explorations and post-surgical complications in patients who undergo microvascular decompression.
KEY POINTS


• Visualisation of the root entry zone by the segmentation-independent volume rendering is in accordance with the landscape by the neuro-endoscopy. • Segmentation-independent volume rendering has an advantage over 3D fast spin echo T2WI in the visualisation of multi-vascular branches compression. • Presurgical 3D visualisation of the neurovascular compression at the root entry zone leads to less postsurgical complications from the decrease of redundant exploration.",2020,"There were fewer complications (7.1% vs 26.8%, p = 0.004) and less operation time (20.7 min vs 14.5 min, p = 0.007) but no significant difference of pain relief (p = 0.19) in the experimental group than in the control group.
","['patients who undergo microvascular decompression', 'Two hundred and twenty patients with VCSs were recruited in this prospective study from July 2015 to May 2019']","['segmentation-independent volume rendering (SI-VR', 'SI-VR and 3D fast spin echo T2WI']","['complications', 'pain relief', 'diagnostic accuracy', 'operation time', 'SI-VR', 'Postsurgical outcomes and complications', 'multi-vascular branches compression', 'Image quality and diagnostic accuracy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1328580', 'cui_str': 'Microvascular Decompression'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}]","[{'cui': 'C0700381', 'cui_str': 'Segmentation (qualifier value)'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205384', 'cui_str': 'Branching (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",220.0,0.0194749,"There were fewer complications (7.1% vs 26.8%, p = 0.004) and less operation time (20.7 min vs 14.5 min, p = 0.007) but no significant difference of pain relief (p = 0.19) in the experimental group than in the control group.
","[{'ForeName': 'Bao', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': ""Department of Radiology, Qilu Hospital of Shandong University, Jinan, 250012, People's Republic of China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Shandong Medical Imaging Research Institute, Shandong University, Jinan, 250021, People's Republic of China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Ming', 'Affiliation': ""Department of Neurosurgery, The Affiliated Hospital of Southwest Medical University, Luzhou, 646000, People's Republic of China.""}, {'ForeName': 'Mingxu', 'Initials': 'M', 'LastName': 'Ge', 'Affiliation': ""Department of Neurosurgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, 250021, People's Republic of China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Wei', 'Affiliation': ""School of Medicine, Shandong University, Jinan, 250012, People's Republic of China.""}, {'ForeName': 'Chuanting', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Shandong Medical Imaging Research Institute, Shandong University, Jinan, 250021, People's Republic of China.""}, {'ForeName': 'Ligang', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""Department of Neurosurgery, The Affiliated Hospital of Southwest Medical University, Luzhou, 646000, People's Republic of China.""}, {'ForeName': 'Xuejun', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Radiology, The Affiliated Hospital of Qingdao University Medical College, Qingdao, 266003, People's Republic of China.""}, {'ForeName': 'Shangchen', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': ""Department of Neurosurgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, 250021, People's Republic of China. Shangchenxu@sina.com.""}, {'ForeName': 'Yingchao', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Neurosurgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, 250021, People's Republic of China. 13805311573@126.com.""}]",European radiology,['10.1007/s00330-020-06715-x']
679,31307055,Continuous Anticoagulation and Cold Snare Polypectomy Versus Heparin Bridging and Hot Snare Polypectomy in Patients on Anticoagulants With Subcentimeter Polyps: A Randomized Controlled Trial.,"Background


Management of anticoagulants for patients undergoing polypectomy is still controversial. Cold snare polypectomy (CSP) is reported to cause less bleeding than hot snare polypectomy (HSP).
Objective


To compare outcomes between continuous administration of anticoagulants (CA) with CSP (CA+CSP) and periprocedural heparin bridging (HB) with HSP (HB+HSP) for subcentimeter colorectal polyps.
Design


Multicenter, parallel, noninferiority randomized controlled trial. (University Hospital Medical Information Network Clinical Trials Registry: UMIN000019355).
Setting


30 Japanese institutions.
Patients


Patients receiving anticoagulant therapy (warfarin or direct oral anticoagulants) who had at least 1 nonpedunculated subcentimeter colorectal polyp.
Intervention


Patients were randomly assigned to undergo HB+HSP or CA+CSP and followed up 28 days after polypectomy.
Measurements


The primary end point was incidence of polypectomy-related major bleeding (based on the incidence of poorly controlled intraprocedural bleeding or postpolypectomy bleeding requiring endoscopic hemostasis). The prespecified inferiority margin was -5% (CA+CSP vs. HB+HSP).
Results


A total of 184 patients were enrolled: 90 in the HB+HSP group, 92 in the CA+CSP group, and 2 who declined to participate after enrollment. The incidence of polypectomy-related major bleeding in the HB+HSP and CA+CSP groups was 12.0% (95% CI, 5.0% to 19.1%) and 4.7% (CI, 0.2% to 9.2%), respectively. The intergroup difference for the primary end point was +7.3% (CI, -1.0% to 15.7%), with a 0.4% lower limit of 2-sided 90% CI, demonstrating the noninferiority of CA+CSP. The mean procedure time for each polyp and the hospitalization period were longer in the HB+HSP than in the CA+CSP group.
Limitation


An open-label trial assessing 2 factors (anticoagulation approach and polypectomy procedure type) simultaneously.
Conclusion


Patients having CA+CSP for subcentimeter colorectal polyps who were receiving oral anticoagulants did not have an increased incidence of polypectomy-related major bleeding, and procedure time and hospitalization were shorter than in those having HB+HSP.
Primary Funding Source


Japanese Gastroenterological Association.",2019,"Cold snare polypectomy (CSP) is reported to cause less bleeding than hot snare polypectomy (HSP).
","['Patients\n\n\nPatients receiving anticoagulant therapy (warfarin or direct oral anticoagulants) who had at least 1 nonpedunculated subcentimeter colorectal polyp', '184 patients were enrolled: 90 in the HB+HSP group, 92 in the CA+CSP group, and 2 who declined to participate after enrollment', 'patients undergoing polypectomy', 'subcentimeter colorectal polyps', 'Patients on Anticoagulants With Subcentimeter Polyps', 'Setting\n\n\n30 Japanese institutions']","['Continuous Anticoagulation and Cold Snare Polypectomy Versus', 'HB+HSP', 'Heparin Bridging and Hot Snare Polypectomy', 'anticoagulants (CA) with CSP (CA+CSP) and periprocedural heparin bridging (HB) with HSP (HB+HSP', 'Cold snare polypectomy (CSP', 'HB+HSP or CA+CSP', 'CA+CSP']","['incidence of polypectomy-related major bleeding, and procedure time and hospitalization', 'incidence of polypectomy-related major bleeding (based on the incidence of poorly controlled intraprocedural bleeding or postpolypectomy bleeding requiring endoscopic hemostasis', 'incidence of polypectomy-related major bleeding', 'mean procedure time for each polyp and the hospitalization period']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150457', 'cui_str': 'Anticoagulant therapy (procedure)'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1446340', 'cui_str': 'Cold snare'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0444519', 'cui_str': 'Hot sensation quality (qualifier value)'}, {'cui': 'C0183362', 'cui_str': 'Snare, device (physical object)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}, {'cui': 'C0456378', 'cui_str': 'Type of bridge (attribute)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0085148', 'cui_str': 'Hemostasis, Endoscopic'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}]",30.0,0.0950026,"Cold snare polypectomy (CSP) is reported to cause less bleeding than hot snare polypectomy (HSP).
","[{'ForeName': 'Yoji', 'Initials': 'Y', 'LastName': 'Takeuchi', 'Affiliation': 'Osaka International Cancer Institute, Osaka, Japan (Y.T.).'}, {'ForeName': 'Katsuhiro', 'Initials': 'K', 'LastName': 'Mabe', 'Affiliation': 'National Hospital Organization Hakodate National Hospital, Hakodate, Japan (K.M.).'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Shimodate', 'Affiliation': 'Kurashiki Central Hospital, Kurashiki, Japan (Y.S.).'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Yoshii', 'Affiliation': 'Sapporo Medical Center Nippon Telegraph and Telephone East Corporation, Sapporo, Japan (S.Y.).'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Yamada', 'Affiliation': 'Ishikawa Prefectural Central Hospital, Kanazawa, Japan (S.Y.).'}, {'ForeName': 'Mineo', 'Initials': 'M', 'LastName': 'Iwatate', 'Affiliation': 'Sano Hospital, Kobe, Japan (M.I.).'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Kawamura', 'Affiliation': 'Kyoto Second Red Cross Hospital, Kyoto, Japan (T.K.).'}, {'ForeName': 'Kinichi', 'Initials': 'K', 'LastName': 'Hotta', 'Affiliation': 'Shizuoka Cancer Center, Suntogun, Shizuoka, Japan (K.H.).'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Nagaike', 'Affiliation': 'Suita Municipal Hospital, Suita, Japan (K.N.).'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Ikezawa', 'Affiliation': 'Akashi Medical Center, Akashi, Japan (N.I.).'}, {'ForeName': 'Tomoaki', 'Initials': 'T', 'LastName': 'Yamasaki', 'Affiliation': 'Osaka City General Hospital, Osaka, Japan (T.Y.).'}, {'ForeName': 'Yoriaki', 'Initials': 'Y', 'LastName': 'Komeda', 'Affiliation': 'Kindai University Faculty of Medicine, Osaka-Sayama, Japan (Y.K.).'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Asai', 'Affiliation': 'Tane General Hospital, Osaka, Japan (S.A.).'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Abe', 'Affiliation': 'Utsunomiya Memorial Hospital, Tochigi, Japan (Y.A.).'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Akamatsu', 'Affiliation': 'Japanese Red Cross Society Wakayama Medical Center, Wakayama, Japan (T.A.).'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Sakakibara', 'Affiliation': 'National Hospital Organization Osaka National Hospital, Osaka, Japan (Y.S.).'}, {'ForeName': 'Hisatomo', 'Initials': 'H', 'LastName': 'Ikehara', 'Affiliation': 'Nihon University School of Medicine, Tokyo, Japan (H.I.).'}, {'ForeName': 'Yuzuru', 'Initials': 'Y', 'LastName': 'Kinjo', 'Affiliation': 'Naha City Hospital, Naha, Japan (Y.K.).'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ohta', 'Affiliation': 'Kansai Rosai Hospital, Amagasaki, Japan (T.O.).'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Kitamura', 'Affiliation': 'Nara City Hospital, Nara, Japan (Y.K.).'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Shono', 'Affiliation': 'Kumamoto University, Kumamoto, Japan (T.S.).'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Osaka General Medical Center, Osaka, Japan (T.I.).'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Ohda', 'Affiliation': 'Hyogo College of Medicine, Nishinomiya, Japan (Y.O.).'}, {'ForeName': 'Nozomu', 'Initials': 'N', 'LastName': 'Kobayashi', 'Affiliation': 'Tochigi Cancer Center, Utsunomiya, Japan (N.K.).'}, {'ForeName': 'Tokuma', 'Initials': 'T', 'LastName': 'Tanuma', 'Affiliation': 'Teine Keijinkai Hospital, Sapporo, Japan (T.T.).'}, {'ForeName': 'Ryu', 'Initials': 'R', 'LastName': 'Sato', 'Affiliation': 'Sapporo Higashi Tokushukai Hospital, Sapporo, Japan (R.S.).'}, {'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Sakamoto', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan (T.S.).'}, {'ForeName': 'Naohiko', 'Initials': 'N', 'LastName': 'Harada', 'Affiliation': 'National Hospital Organization Kyushu Medical Center, Fukuoka, Japan (N.H.).'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Chino', 'Affiliation': 'Cancer Institute Hospital, Tokyo, Japan (A.C.).'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Ishikawa', 'Affiliation': 'Kyoto Prefectural University of Medicine, Osaka, Japan (H.I.).'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Nojima', 'Affiliation': 'The University of Tokyo, Tokyo, Japan (M.N.).'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Uraoka', 'Affiliation': 'National Hospital Organization Tokyo Medical Center, Tokyo, Japan (T.U.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of internal medicine,['10.7326/M19-0026']
680,31436631,Occipital and Cerebellar Theta Burst Stimulation for Mal De Debarquement Syndrome.,"BACKGROUND


Individuals with Mal de Debarquement syndrome (MdDS) experience persistent oscillating vertigo lasting for months or years. Transcranial magnetic stimulation (TMS) can modulate the motion perception of MdDS.
MATERIALS AND METHODS


Twenty-six TMS naive individuals received single administrations of continuous theta burst stimulation (cTBS) over the occipital cortex, cerebellar vermis, and lateral cerebellar hemisphere, in randomized order. A 0-100 point Visual Analogue Scale was used to assess acute changes in oscillating vertigo severity after each session. Repeated treatments were given over the target that led to the most acute reduction in symptoms. All treatments were performed with neuronavigation using the participant's own brain MRI. The Dizziness Handicap Inventory (DHI), MdDS Balance Rating Scale (MBRS), and Hospital Anxiety and Depression Scale (HADS) were assessed weekly at four pretreatment and six posttreatment time points.
RESULTS


Twenty participants chose either the occipital cortex (11) or cerebellar vermis (9) targets as most effective in reducing the oscillating vertigo; one chose lateral cerebellar hemisphere; five chose none. After 10 to 12 sessions of 1,200 pulses over the target of choice, 19 of 25 treatment completers noted ≥ 25% reduction, 12 of 25 ≥50% reduction, and 8 of 25 ≥75% reduction in oscillating vertigo intensity. A one-way repeated measures ANOVA of DHI, MBRS, and HADS scores before and after treatment showed significant reductions in DHI, MBRS, and the HADS Anxiety subscore immediately after treatment with most improvement lasting through posttreatment week 6. There were no significant Depression subscore changes. Participants who had chosen vermis stimulation had comparatively worse balance at baseline than those who had chosen occipital cortex stimulation.
CONCLUSION


cTBS over either the occipital cortex or cerebellar vermis is effective in reducing the oscillating vertigo of MdDS acutely and may confer long-term benefits. Sustained improvement requires more frequent treatments.",2019,A 0-100 point Visual Analogue Scale was used to assess acute changes in oscillating vertigo severity after each session.,"['Individuals with Mal de Debarquement syndrome (MdDS) experience persistent oscillating vertigo lasting for months or years', 'Twenty-six TMS naive individuals received']","['Occipital and Cerebellar Theta Burst Stimulation', 'Transcranial magnetic stimulation (TMS', 'single administrations of continuous theta burst stimulation (cTBS']","['DHI, MBRS, and HADS scores', 'DHI, MBRS, and the HADS Anxiety subscore', 'Dizziness Handicap Inventory (DHI), MdDS Balance Rating Scale (MBRS), and Hospital Anxiety and Depression Scale (HADS', 'Depression subscore changes', 'oscillating vertigo intensity', 'oscillating vertigo']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1608983', 'cui_str': 'Mal de debarquement syndrome'}, {'cui': 'C0042571', 'cui_str': 'Spinning Sensation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}]","[{'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}]","[{'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0222045'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0042571', 'cui_str': 'Spinning Sensation'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",20.0,0.0440048,A 0-100 point Visual Analogue Scale was used to assess acute changes in oscillating vertigo severity after each session.,"[{'ForeName': 'Yoon-Hee', 'Initials': 'YH', 'LastName': 'Cha', 'Affiliation': 'Laureate Institute for Brain Research.'}, {'ForeName': 'Diamond', 'Initials': 'D', 'LastName': 'Gleghorn', 'Affiliation': 'Laureate Institute for Brain Research.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Doudican', 'Affiliation': 'Laureate Institute for Brain Research.'}]","Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology",['10.1097/MAO.0000000000002341']
681,30705390,Screening and brief intervention for obesity in primary care: cost-effectiveness analysis in the BWeL trial.,"BACKGROUND


The Brief Intervention for Weight Loss Trial enrolled 1882 consecutively attending primary care patients who were obese and participants were randomised to physicians opportunistically endorsing, offering, and facilitating a referral to a weight loss programme (support) or recommending weight loss (advice). After one year, the support group lost 1.4 kg more (95%CI 0.9 to 2.0): 2.4 kg versus 1.0 kg. We use a cohort simulation to predict effects on disease incidence, quality of life, and healthcare costs over 20 years.
METHODS


Randomly sampling from the trial population, we created a virtual cohort of 20 million adults and assigned baseline morbidity. We applied the weight loss observed in the trial and assumed weight regain over four years. Using epidemiological data, we assigned the incidence of 12 weight-related diseases depending on baseline disease status, age, gender, body mass index. From a healthcare perspective, we calculated the quality adjusted life years (QALYs) accruing and calculated the incremental difference between trial arms in costs expended in delivering the intervention and healthcare costs accruing. We discounted future costs and benefits at 1.5% over 20 years.
RESULTS


Compared with advice, the support intervention reduced the cumulative incidence of weight-related disease by 722/100,000 people, 0.33% of all weight-related disease. The incremental cost of support over advice was £2.01million/100,000. However, the support intervention reduced health service costs by £5.86 million/100,000 leading to a net saving of £3.85 million/100,000. The support intervention produced 992 QALYs/100,000 people relative to advice.
CONCLUSIONS


A brief intervention in which physicians opportunistically endorse, offer, and facilitate a referral to a behavioural weight management service to patients with a BMI of at least 30 kg/m 2  reduces healthcare costs and improves health more than advising weight loss.",2019,"Compared with advice, the support intervention reduced the cumulative incidence of weight-related disease by 722/100,000 people, 0.33% of all weight-related disease.","['Randomly sampling from the trial population, we created a virtual cohort of 20 million adults and assigned baseline morbidity', 'patients with a BMI of at least 30\u2009kg/m 2  reduces healthcare costs and improves health more than advising weight loss', '1882 consecutively attending primary care patients who were obese and participants']","['physicians opportunistically endorsing, offering, and facilitating a referral to a weight loss programme (support) or recommending weight loss (advice']","['disease incidence, quality of life, and healthcare costs', 'cumulative incidence of weight-related disease', 'weight loss', 'health service costs']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0034380'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",1882.0,0.159942,"Compared with advice, the support intervention reduced the cumulative incidence of weight-related disease by 722/100,000 people, 0.33% of all weight-related disease.","[{'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Retat', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pimpin', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Webber', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Abbygail', 'Initials': 'A', 'LastName': 'Jaccard', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Lewis', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Tearne', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Christian-Brown', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Peymane', 'Initials': 'P', 'LastName': 'Adab', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, West Midlands, B15 2TT, UK.'}, {'ForeName': 'Rachna', 'Initials': 'R', 'LastName': 'Begh', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jolly', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, West Midlands, B15 2TT, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Daley', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Ashby Road, Loughborough, Leicestershire, LE11 3TU, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Farley', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, West Midlands, B15 2TT, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Lycett', 'Affiliation': 'Faculty of Health and Life Sciences, Coventry University, Priory Street, Coventry, CV1 5FB, UK.'}, {'ForeName': 'Alecia', 'Initials': 'A', 'LastName': 'Nickless', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Ly-Mee', 'Initials': 'LM', 'LastName': 'Yu', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK. paul.aveyard@phc.ox.ac.uk.'}]",International journal of obesity (2005),['10.1038/s41366-018-0295-7']
682,32218302,The Effect of The Daily Mile on Primary School Children's Aerobic Fitness Levels After 12 Weeks: A Controlled Trial.,"The Daily Mile (TDM) is a school-based physical activity intervention encompassing a 15-minute run at least three times per week. This study aimed to determine (1) the effects of performing TDM for 12 weeks on Dutch primary school children's aerobic fitness levels and (2) if additional personal support for teachers impacted the effectiveness of TDM. Nine Dutch primary schools ( n  = 659 children, grades 5-8) were allocated to a control (no TDM), intervention (12 weeks TDM) or intervention-plus (12 weeks TDM, additional personal support) group. The Shuttle Run Test (SRT) was used to assess aerobic fitness at baseline and follow-up. Data were analyzed using a multiple-imputed dataset and multilevel linear regression models to account for the clustering of students within classes and classes within schools. The regression analyses were adjusted for sex and age. Compared with the control group, significant intervention effects of TDM on SRT score were observed for the intervention group (β = 1.1; 95% CI: 0.8; 1.5) and the intervention-plus group (β = 0.6; 95% CI 0.3; 0.9). Additional personal support had no impact on the effectiveness of TDM. These results suggest that performing TDM at least three times per week for approximately 12 weeks increases primary school children's aerobic fitness. Additional personal support did not improve the effectiveness of TDM on aerobic fitness within this period. These results contribute to the body of evidence surrounding TDM, but further research is needed regarding long-term implementation of TDM.",2020,"Compared with the control group, significant intervention effects of TDM on SRT score were observed for the intervention group (β = 1.1; 95% CI: 0.8; 1.5) and the intervention-plus group (β = 0.6; 95% CI 0.3; 0.9).","[""Primary School Children's Aerobic Fitness Levels After 12 Weeks"", 'Nine Dutch primary schools ( n  = 659 children, grades 5-8', ""Dutch primary school children's aerobic fitness levels and (2""]","['Shuttle Run Test (SRT', 'Daily Mile', 'TDM', 'control (no TDM), intervention (12 weeks TDM) or intervention-plus (12 weeks TDM, additional personal support']","['effectiveness of TDM', 'SRT score', 'aerobic fitness']","[{'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]","[{'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold (observable entity)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0331865', 'cui_str': 'Mile (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",659.0,0.0264183,"Compared with the control group, significant intervention effects of TDM on SRT score were observed for the intervention group (β = 1.1; 95% CI: 0.8; 1.5) and the intervention-plus group (β = 0.6; 95% CI 0.3; 0.9).","[{'ForeName': 'Maxine', 'Initials': 'M', 'LastName': 'de Jonge', 'Affiliation': 'Mulier Institute, Herculesplein 269, 3584 AA Utrecht, The Netherlands.'}, {'ForeName': 'Jorien J', 'Initials': 'JJ', 'LastName': 'Slot-Heijs', 'Affiliation': 'Mulier Institute, Herculesplein 269, 3584 AA Utrecht, The Netherlands.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Prins', 'Affiliation': 'Mulier Institute, Herculesplein 269, 3584 AA Utrecht, The Netherlands.'}, {'ForeName': 'Amika S', 'Initials': 'AS', 'LastName': 'Singh', 'Affiliation': 'Mulier Institute, Herculesplein 269, 3584 AA Utrecht, The Netherlands.'}]",International journal of environmental research and public health,['10.3390/ijerph17072198']
683,31886854,Screening and topical decolonization of preoperative nasal Staphylococcus aureus carriers to reduce the incidence of postoperative infections after lung cancer surgery: a propensity matched study.,"OBJECTIVES


Health care-associated infections (HAIs) are serious issues following lung cancer surgery, leading to an increased risk of morbidity and hospital cost burden. The aim of this study was to evaluate the impact on postoperative outcomes of a preoperative screening and decolonization strategy of nasal carriers for Staphylococcus aureus prior to lung cancer surgery.
METHODS


We performed a retrospective study comparing 2 cohorts of patients undergoing major lung resection: a control group of patients from the placebo arm of the randomized Clinical Study to Evaluate the Efficacy of Chlorhexidine Mouthwashes operated on between July 2012 and April 2015 without any nasopharyngeal screening (N = 224); an experimental group, with preoperative screening for S. aureus of nasal carriers and selective 5-day decolonization in positive carriers using mupirocin ointment between January 2017 and December 2017 (N = 310). The 2 groups were matched according to a propensity score analysis with 1:1 matching. The primary outcome was the rate of postoperative HAIs, and the secondary outcome was the need for postoperative mechanical ventilation after surgery.
RESULTS


After matching, 2 similar groups of 108 patients each were obtained. In the experimental group, 26 patients had positive results for nasal carriage, and a significant decrease was observed in the rate of overall postoperative HAIs [control n = 19, 17.6%; experimental group n = 9, 8.3%; P = 0.043; relative risk 0.47 (0.22-1)] and in the rate of postoperative mechanical ventilation [control n = 12, 11.1%; experimental group n = 4, 3.7%; P = 0.038; relative risk 0.33 (0.11-1)]. After logistic regression and multivariable analysis, screening of S. aureus nasal carriers reduced the rate of HAIs [odds ratio (OR) 0.29, 95% confidence interval (CI) 0.11-0.76; P = 0.01] and reduced the risk of the need for postoperative mechanical ventilation (OR 0.19, 95% CI 0.05-0.74; P = 0.02). There was no significant statistical difference between the 2 groups regarding the rate of postoperative S. aureus-associated infection (control group n = 6, 5.6%; experimental group n = 2, 1.9%; P = 0.28).
CONCLUSIONS


Identification of nasal carriers of S. aureus and selective decontamination using mupirocin appeared to have a beneficial effect on postoperative infectious events after lung resection surgery.",2020,"There was no significant statistical difference between the 2 groups regarding the rate of postoperative S. aureus-associated infection (control group n = 6, 5.6%; experimental group n = 2, 1.9%; P = 0.28).
","['patients undergoing major lung resection', 'lung cancer surgery', 'operated on between July 2012 and April 2015 without any nasopharyngeal screening (N\u2009=\u2009224); an experimental group, with preoperative screening for S. aureus of nasal carriers and selective 5-day decolonization in positive carriers using mupirocin ointment between January 2017 and December 2017 (N\u2009=\u2009310']","['placebo', 'preoperative screening and decolonization strategy', 'Chlorhexidine Mouthwashes']","['postoperative mechanical ventilation after surgery', 'rate of postoperative mechanical ventilation', 'nasal carriage', 'rate of overall postoperative HAIs', 'rate of postoperative S. aureus-associated infection', 'rate of postoperative HAIs', 'risk of the need for postoperative mechanical ventilation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0027442', 'cui_str': 'Rhinopharynx'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0560175', 'cui_str': 'Carrier State'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4520447', 'cui_str': 'Decolonization'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0085259', 'cui_str': 'Mupirocin'}, {'cui': 'C0028912', 'cui_str': 'Salves'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C4520447', 'cui_str': 'Decolonization'}, {'cui': 'C3666901', 'cui_str': 'Chlorhexidine Mouthwash [Paroex]'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}]",108.0,0.271116,"There was no significant statistical difference between the 2 groups regarding the rate of postoperative S. aureus-associated infection (control group n = 6, 5.6%; experimental group n = 2, 1.9%; P = 0.28).
","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Fourdrain', 'Affiliation': 'Service de Chirurgie Thoracique, Aix-Marseille Université, CNRS, INSERM, Centre de Recherche en Cancérologie de Marseille (CRCM), Assistance-Publique Hôpitaux de Marseille, Marseille, France.'}, {'ForeName': 'Ilies', 'Initials': 'I', 'LastName': 'Bouabdallah', 'Affiliation': 'Service de Chirurgie Thoracique, Aix-Marseille Université, CNRS, INSERM, Centre de Recherche en Cancérologie de Marseille (CRCM), Assistance-Publique Hôpitaux de Marseille, Marseille, France.'}, {'ForeName': 'Lucile', 'Initials': 'L', 'LastName': 'Gust', 'Affiliation': 'Service de Chirurgie Thoracique, Aix-Marseille Université, CNRS, INSERM, Centre de Recherche en Cancérologie de Marseille (CRCM), Assistance-Publique Hôpitaux de Marseille, Marseille, France.'}, {'ForeName': 'Nadim', 'Initials': 'N', 'LastName': 'Cassir', 'Affiliation': 'Aix-Marseille Université, IHU, MEPHI, CLIN, Assistance-Publique Hôpitaux de Marseille, Marseille, France.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Brioude', 'Affiliation': 'Service de Chirurgie Thoracique, Aix-Marseille Université, CNRS, INSERM, Centre de Recherche en Cancérologie de Marseille (CRCM), Assistance-Publique Hôpitaux de Marseille, Marseille, France.'}, {'ForeName': 'Pierre-Emmanuel', 'Initials': 'PE', 'LastName': 'Falcoz', 'Affiliation': 'Service de Chirurgie Thoracique, Nouvel Hôpital Civil, Strasbourg Université, Strasbourg, France.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Alifano', 'Affiliation': 'Service de Chirurgie Thoracique, Hôpital Cochin, Assistance Publique Hôpitaux de Paris, Paris Descartes Université, Paris, France.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Le Rochais', 'Affiliation': 'Service de Chirurgie Thoracique, Hôpital de la côte de Nacre, Caen Université, Caen, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': ""D'Annoville"", 'Affiliation': 'Service de Chirurgie Thoracique, Hôpital Arnaud de Villeneuve, Montpellier Université, Montpellier, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Trousse', 'Affiliation': 'Service de Chirurgie Thoracique, Aix-Marseille Université, CNRS, INSERM, Centre de Recherche en Cancérologie de Marseille (CRCM), Assistance-Publique Hôpitaux de Marseille, Marseille, France.'}, {'ForeName': 'Anderson', 'Initials': 'A', 'LastName': 'Loundou', 'Affiliation': ""Unité d'aide méthodologique, Assistance Publique Hôpitaux de Marseille, Aix-Marseille Université, Marseille, France.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Leone', 'Affiliation': 'Aix-Marseille Université, IHU, MEPHI, CLIN, Assistance-Publique Hôpitaux de Marseille, Marseille, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Papazian', 'Affiliation': 'Réanimation des Détresses Respiratoires et Infections Sévères, Hôpital Nord, Assistance Publique Hôpitaux de Marseille, Aix-Marseille Université, Marseille, France.'}, {'ForeName': 'Pascal Alexandre', 'Initials': 'PA', 'LastName': 'Thomas', 'Affiliation': 'Service de Chirurgie Thoracique, Aix-Marseille Université, CNRS, INSERM, Centre de Recherche en Cancérologie de Marseille (CRCM), Assistance-Publique Hôpitaux de Marseille, Marseille, France.'}, {'ForeName': 'Xavier Benoit', 'Initials': 'XB', 'LastName': ""D'Journo"", 'Affiliation': 'Service de Chirurgie Thoracique, Aix-Marseille Université, CNRS, INSERM, Centre de Recherche en Cancérologie de Marseille (CRCM), Assistance-Publique Hôpitaux de Marseille, Marseille, France.'}]",Interactive cardiovascular and thoracic surgery,['10.1093/icvts/ivz305']
684,32145412,The Utility of Early Postoperative Neuroimaging in Elective/Semielective Craniotomy Patients: A Single-Arm Prospective Trial.,"BACKGROUND


The necessity and timing of early postoperative imaging (POI) are debated in many studies. Despite the consensus that early POI does not change patient management, these examinations are routinely performed. This is the first prospective study related to POI. Our aims were to assess the necessity of early POI in asymptomatic patients and to verify accuracy of the presented algorithm.
METHODS


This was an algorithm-based prospective single-center study. The algorithm addressed preoperative, perioperative, and postoperative considerations, including estimated pathology type, device placement, and postoperative neurologic change. Early computed tomography scans were obtained in all patients, but if postoperative algorithm indications did not recommend a scan, the treating team was blinded to them, and patient management was conducted based on clinical examinations alone. A neuroradiologist and study-independent neurosurgeon reviewed all the scans.
RESULTS


Of 103 enrolled patients, 88 remained asymptomatic, and 15 experienced symptoms postoperatively. Pathology was present on POI in 1% of the asymptomatic patients and 53% of the symptomatic patients (P < 0.001). In the asymptomatic group, no treatment modifications were made postoperatively. Blinding of the surgical team was not removed, and 20% of the symptomatic patients returned to the operating room because of imaging and neurologic findings. The goal of <5% algorithm failure was reached with statistical significance.
CONCLUSIONS


In asymptomatic postoperative patients in whom early imaging is not performed for oncologic indications, device placement verification, or similar reasons, POI is unnecessary and does not change the management of these patients.",2020,One percent of the asymptomatic and 53% of the symptomatic patients had pathologic POI (p<.001).,"['elective/semi-elective craniotomy patients', 'Out of a 103 enrolled', 'asymptomatic patient']",[],['pathologic POI'],"[{'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0660985', 'cui_str': 'D-Glucose, 2-deoxy-2-((1-oxo-3-((1-oxotetradecyl)oxy)tetradecyl)amino)-, 4-(dihydrogen phosphate) 3-(3-((1-oxotetradecyl)oxy)tetradecanoate), (2(R),3(R))-'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}]",[],"[{'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0443045', 'cui_str': 'Poi (qualifier value)'}]",103.0,0.0666964,One percent of the asymptomatic and 53% of the symptomatic patients had pathologic POI (p<.001).,"[{'ForeName': 'Ido', 'Initials': 'I', 'LastName': 'Ben Zvi', 'Affiliation': 'Neurosurgery Department, Rabin Medical Center, Petah Tikva, Israel. Electronic address: idobenz@gmail.com.'}, {'ForeName': 'Sher', 'Initials': 'S', 'LastName': 'Matsri', 'Affiliation': 'Neurosurgery Department, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Felzensztein', 'Affiliation': 'Neurosurgery Department, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Yassin', 'Affiliation': 'Neurosurgery Department, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Alon', 'Initials': 'A', 'LastName': 'Orlev', 'Affiliation': 'Neurosurgery Department, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Netanel', 'Initials': 'N', 'LastName': 'Ben Shalom', 'Affiliation': 'Neurosurgery Department, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Shlomo', 'Initials': 'S', 'LastName': 'Gavrielli', 'Affiliation': 'Department of Diagnostic Radiology, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Edna', 'Initials': 'E', 'LastName': 'Inbar', 'Affiliation': 'Department of Diagnostic Radiology, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Loeub', 'Affiliation': 'Neurosurgery Department, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Noa', 'Initials': 'N', 'LastName': 'Schwartz', 'Affiliation': 'Neurosurgery Department, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Rajz', 'Affiliation': 'Neurosurgery Department, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Novitsky', 'Affiliation': 'Neurosurgery Department, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Kanner', 'Affiliation': 'Neurosurgery Department, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Shani', 'Initials': 'S', 'LastName': 'Berkowitz', 'Affiliation': 'Neurosurgery Department, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Sagi', 'Initials': 'S', 'LastName': 'Harnof', 'Affiliation': 'Neurosurgery Department, Rabin Medical Center, Petah Tikva, Israel.'}]",World neurosurgery,['10.1016/j.wneu.2020.02.130']
685,30311037,Role of closed drain after multi-level posterior spinal surgery in adults: a randomised open-label superiority trial.,"PURPOSE


To explore the role of closed suction drain in multi-level posterior spinal surgery.
METHODS


We performed prospective, open-label, randomised control, superiority trial with parallel design and 1:1 allocation. A total of 161 patients undergoing posterior spinal surgery involving more than one motion segment at a dedicated spine surgery department were randomly allocated into ""drain"" or ""no-drain"" groups, based on which surgical drain was employed at the end of surgery. After excluding six cases with intraoperative dural tear, the data of 80 patients in ""drain"" and 75 patients in ""no-drain"" group were analysed. Primary outcome was total perioperative blood loss (sum of intraoperative blood loss, volume of drain if present and volume aspirated if patient developed collection in relation to surgical wound). The secondary outcomes were transfusion requirements, wound healing and complications.
RESULTS


Both groups were comparable with respect to baseline characteristics. Total perioperative blood loss was significantly higher in ""drain"" group (716 ± 312.97 ml vs 377.9 ± 295.72 ml, p < 0.0001). Number and volume of post-operative aspirations were significantly higher in ""no-drain"" group whereas transfusion requirements were significantly higher in ""drain"" group. Except for one case of superficial wound inflammation in either group, there were no complications. Subgroup analysis revealed that the results were applicable for surgeries involving ""two/three"" levels and ""more than three"" levels.
CONCLUSIONS


The practice of not using closed surgical drains after multi-level posterior spinal surgery reduces post-operative blood loss and transfusion requirements. But this comes with the disadvantage of increased wound soakage and need for post-operative wound aspirations. The risks of benefits of ""drain"" and ""no drain"" must be carefully weighed and an informed choice be taken. These slides can be retrieved under Electronic Supplementary Material.",2019,"Number and volume of post-operative aspirations were significantly higher in ""no-drain"" group whereas transfusion requirements were significantly higher in ""drain"" group.","['161 patients undergoing posterior spinal surgery involving more than one motion segment at a dedicated spine surgery department', 'adults']","['closed drain after multi-level posterior spinal surgery', 'closed suction drain', 'drain"" or ""no-drain"" groups, based on which surgical drain']","['transfusion requirements', 'Total perioperative blood loss', 'transfusion requirements, wound healing and complications', 'Number and volume of post-operative aspirations', 'superficial wound inflammation', 'total perioperative blood loss (sum of intraoperative blood loss, volume of drain if present and volume']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0441139', 'cui_str': 'Suction drain (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2607832', 'cui_str': 'Surgical drain (physical object)'}]","[{'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C0332804', 'cui_str': 'Superficial wound (morphologic abnormality)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]",161.0,0.134424,"Number and volume of post-operative aspirations were significantly higher in ""no-drain"" group whereas transfusion requirements were significantly higher in ""drain"" group.","[{'ForeName': 'Alexander Vadimovich', 'Initials': 'AV', 'LastName': 'Gubin', 'Affiliation': 'Federal State Budgetary Institution Russian Ilizarov Scientific Center for ""Restorative Traumatology and Orthopaedics"", Ministry of Healthcare, Russian Federation, Kurgan, Russia.'}, {'ForeName': 'Oksana Germanovna', 'Initials': 'OG', 'LastName': 'Prudnikova', 'Affiliation': 'Scientific and Clinical Laboratory of Axial Skeleton Pathology and Neurosurgery, Head of Trauma and Orthopedic Dept. No 10, Federal State Budgetary Institution Russian Ilizarov Scientific Center for ""Restorative Traumatology and Orthopaedics"", Ministry of Healthcare, Russian Federation, Kurgan, Russia.'}, {'ForeName': 'Koushik Narayan', 'Initials': 'KN', 'LastName': 'Subramanyam', 'Affiliation': 'Department of Orthopaedics, Sri Sathya Sai Institute of Higher Medical Sciences - Prasanthigram, Puttaparthi, Andhra Pradesh, 515134, India. drkoushik@hotmail.com.'}, {'ForeName': 'Alexander Vladimirovich', 'Initials': 'AV', 'LastName': 'Burtsev', 'Affiliation': 'Scientific and Clinical Laboratory of Axial Skeleton Pathology and Neurosurgery, Surgeon of Trauma and Orthopedic Dept. No 10, Federal State Budgetary Institution Russian Ilizarov Scientific Center for ""Restorative Traumatology and Orthopaedics"", Ministry of Healthcare, Russian Federation, Kurgan, Russia.'}, {'ForeName': 'Maxim Viktorovich', 'Initials': 'MV', 'LastName': 'Khomchenkov', 'Affiliation': 'Scientific and Clinical Laboratory of Axial Skeleton Pathology and Neurosurgery, Surgeon of Trauma and Orthopedic Dept. No 10, Federal State Budgetary Institution Russian Ilizarov Scientific Center for ""Restorative Traumatology and Orthopaedics"", Ministry of Healthcare, Russian Federation, Kurgan, Russia.'}, {'ForeName': 'Abhishek Vasant', 'Initials': 'AV', 'LastName': 'Mundargi', 'Affiliation': 'Department of Orthopaedics, Sri Sathya Sai Institute of Higher Medical Sciences - Prasanthigram, Puttaparthi, Andhra Pradesh, 515134, India.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-018-5791-x']
686,32221819,Voluntary Vs Nominated Peer Educators: a Randomized Trial within the NoTrap! Anti-Bullying Program.,"There is a debate in scientific literature about the effectiveness of a peer-led approach to anti-bullying interventions. In order to understand which circumstances and for whom these approaches work best, the present study was carried out within the NoTrap! anti-bullying program. Using a cluster design, classes were randomly assigned into two different peer educator recruitment strategies: volunteering (N = 500; 48% females; mean age = 13.5 years, ds = 1.3) vs peer nominated (N = 466; 38% females; mean age = 13.9 years, ds = 1.3). Results showed that voluntary peer educators suffered a higher level of victimization, while the nominated ones tended to be more popular and likable. Furthermore, a set of linear mixed-effect models showed that the program was effective in reducing bullying and victimization, and in increasing defending behaviour only in the voluntary recruitment condition. On the contrary, in classrooms under the peer nominated recruitment condition, bullying and victimization remained stable, and defending behaviour increased only for peer educators, but not for their classmates. This implies that the step of peer selection and recruitment must be kept into consideration in developing and validating an intervention, because of its possible impact on the effectiveness of the whole intervention.",2020,"Furthermore, a set of linear mixed-effect models showed that the program was effective in reducing bullying and victimization, and in increasing defending behaviour only in the voluntary recruitment condition.","['N\u2009=\u2009500; 48% females; mean age\u2009=\u200913.5\xa0years, ds\u2009=\u20091.3) vs peer nominated (N\u2009=\u2009466; 38% females; mean age\u2009=\u200913.9\xa0years, ds\u2009=\u20091.3']","['Voluntary Vs Nominated Peer Educators', 'peer educator recruitment strategies: volunteering']",['level of victimization'],"[{'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517559', 'cui_str': '13.5 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}, {'cui': 'C4517562', 'cui_str': '13.9 (qualifier value)'}]","[{'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}]",,0.0193506,"Furthermore, a set of linear mixed-effect models showed that the program was effective in reducing bullying and victimization, and in increasing defending behaviour only in the voluntary recruitment condition.","[{'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Zambuto', 'Affiliation': 'Department of Education, Languages, Interculture, Literature and Psychology, University of Florence, Sede di via di San Salvi 12, Padiglione 26, 50135, Florence, Italy.'}, {'ForeName': 'Benedetta Emanuela', 'Initials': 'BE', 'LastName': 'Palladino', 'Affiliation': 'Department of Education, Languages, Interculture, Literature and Psychology, University of Florence, Sede di via di San Salvi 12, Padiglione 26, 50135, Florence, Italy. benedettaemanuela.palladino@unifi.it.'}, {'ForeName': 'Annalaura', 'Initials': 'A', 'LastName': 'Nocentini', 'Affiliation': 'Department of Education, Languages, Interculture, Literature and Psychology, University of Florence, Sede di via di San Salvi 12, Padiglione 26, 50135, Florence, Italy.'}, {'ForeName': 'Ersilia', 'Initials': 'E', 'LastName': 'Menesini', 'Affiliation': 'Department of Education, Languages, Interculture, Literature and Psychology, University of Florence, Sede di via di San Salvi 12, Padiglione 26, 50135, Florence, Italy.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01108-4']
687,32219502,Correction to: Translational immune correlates of indirect antibody immunization in a randomized phase II study using scheduled combination therapy with carboplatin/paclitaxel plus oregovomab in ovarian cancer patients.,The original version of this article unfortunately contained a mistake.,2020,The original version of this article unfortunately contained a mistake.,['ovarian cancer patients'],['carboplatin/paclitaxel plus oregovomab'],[],"[{'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0664207', 'cui_str': 'oregovomab'}]",[],,0.0174148,The original version of this article unfortunately contained a mistake.,"[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Battaglia', 'Affiliation': 'Istituto di Clinica Ostetrica e Ginecologica, Università Cattolica del Sacro Cuore, L.go F.Vito 1, 00168, Rome, Italy. alessandra.battaglia@unicatt.it.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Buzzonetti', 'Affiliation': 'Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Fossati', 'Affiliation': 'Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': 'Istituto di Clinica Ostetrica e Ginecologica, Università Cattolica del Sacro Cuore, L.go F.Vito 1, 00168, Rome, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Fattorossi', 'Affiliation': 'Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Madi R', 'Initials': 'MR', 'LastName': 'Madiyalakan', 'Affiliation': 'OncoQuest inc., Edmonton, AB, Canada.'}, {'ForeName': 'Yolanda D', 'Initials': 'YD', 'LastName': 'Mahnke', 'Affiliation': 'FlowKnowHow LLC, New York, NY, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Nicodemus', 'Affiliation': 'AIT Strategies, Franconia, NH, USA.'}]","Cancer immunology, immunotherapy : CII",['10.1007/s00262-020-02537-4']
688,31035003,Tissue-specific role of Nrf2 in the treatment of diabetic foot ulcers during hyperbaric oxygen therapy.,"Hyperbaric oxygen (HBO) therapy is proven to be very successful for diabetic foot ulcer (DFU) treatment due to its antimicrobial effect, increased angiogenesis and enhanced collagen synthesis. The molecular mechanism underlying HBO therapy particularly the involvement of Nrf2 in the wound healing process was investigated in the present study. In addition, we have studied the levels of angiogenic markers in ulcer tissues and their correlation with Nrf2 during HBO therapy compared with standard therapy (Non-HBO) for DFU. A total of 32 Patients were recruited and randomized to standard wound care procedure alone (n = 17) or HBO therapy in combination with standard wound care procedure (n = 15) for 20 days. Our results showed that the tissue levels of Nrf2 along with its downstream targets were significantly increased in patients who underwent HBO therapy when compared to Non-HBO therapy. Further, HBO therapy induced angiogenesis as assessed by increased levels of angiogenesis markers such as EGF, VEGF, PDGF, FGF-2 and CXCL10 in the tissue samples. The expressions of eNOS and nitrite concentrations were also significantly increased in HBO therapy when compared to Non-HBO therapy subjects. Moreover, HBO therapy sensitises the macrophages to release FGF-2 and EGF thereby promotes angiogenesis. Further, it increased the levels of neutrophil attractant CXCL-8 thereby promotes the release of chemokine CCL2, a well-known mediator of neovascularization. The Pearson correlation showed that Nrf2 has a positive correlation with EGF, VEGF and PDGF. In conclusion, the findings of the present study suggest that HBO therapy promotes wound healing by increasing oxygen supply and distribution to damaged tissues, stimulating angiogenesis, decreasing inflammation, and increasing the nitrite levels. Increased levels of Nrf2 transiently regulate the expression of angiogenic genes in wound biopsies, which may result in accelerated healing of chronic wounds.",2019,The expressions of eNOS and nitrite concentrations were also significantly increased in HBO therapy when compared to Non-HBO therapy subjects.,['A total of 32 Patients'],"['Hyperbaric oxygen (HBO) therapy', 'HBO therapy', 'standard wound care procedure alone (n\u202f=\u202f17) or HBO therapy in combination with standard wound care procedure', 'hyperbaric oxygen therapy']","['tissue levels of Nrf2', 'levels of angiogenesis markers such as EGF, VEGF, PDGF, FGF-2 and CXCL10', 'expressions of eNOS and nitrite concentrations']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0020431', 'cui_str': 'Hyperbaric Oxygen Therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0886052', 'cui_str': 'Administers care to wound sites'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0242275', 'cui_str': 'Epidermal Growth Factor'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0380603', 'cui_str': 'Prostate Epithelial Cell Growth Factor'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0427757', 'cui_str': 'Dipstick test of nitrite concentration'}]",32.0,0.0177052,The expressions of eNOS and nitrite concentrations were also significantly increased in HBO therapy when compared to Non-HBO therapy subjects.,"[{'ForeName': 'Umapathy', 'Initials': 'U', 'LastName': 'Dhamodharan', 'Affiliation': 'SRM Research Institute, SRM Institute of Science and Technology, Kattankulathur, 603 203, Tamilnadu, India.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Karan', 'Affiliation': 'Department of Biotechnology, School of Bio-engineering, SRM Institute of Science and Technology, Kattankulathur, 603 203, Tamilnadu, India.'}, {'ForeName': 'Dornadula', 'Initials': 'D', 'LastName': 'Sireesh', 'Affiliation': 'Department of Biotechnology, School of Bio-engineering, SRM Institute of Science and Technology, Kattankulathur, 603 203, Tamilnadu, India.'}, {'ForeName': 'Alladi', 'Initials': 'A', 'LastName': 'Vaishnavi', 'Affiliation': 'Department of Biotechnology, School of Bio-engineering, SRM Institute of Science and Technology, Kattankulathur, 603 203, Tamilnadu, India.'}, {'ForeName': 'Arumugam', 'Initials': 'A', 'LastName': 'Somasundar', 'Affiliation': 'Department of Biotechnology, School of Bio-engineering, SRM Institute of Science and Technology, Kattankulathur, 603 203, Tamilnadu, India.'}, {'ForeName': 'Kesavan', 'Initials': 'K', 'LastName': 'Rajesh', 'Affiliation': 'Department of Podiatry, Hycare Super Speciality Hospital, MMDA Colony, Arumbakkam, Chennai, 600 106, Tamilnadu, India. Electronic address: hycareforwound@gmail.com.'}, {'ForeName': 'Kunka Mohanram', 'Initials': 'KM', 'LastName': 'Ramkumar', 'Affiliation': 'SRM Research Institute, SRM Institute of Science and Technology, Kattankulathur, 603 203, Tamilnadu, India; Department of Biotechnology, School of Bio-engineering, SRM Institute of Science and Technology, Kattankulathur, 603 203, Tamilnadu, India. Electronic address: ramkumar.km@res.srmuniv.ac.in.'}]",Free radical biology & medicine,['10.1016/j.freeradbiomed.2019.04.031']
689,31082507,"Dietary intake of inorganic nitrate in vegetarians and omnivores and its impact on blood pressure, resting metabolic rate and the oral microbiome.","Vegetarian diets are commonly associated with lower blood pressure levels. This has been related to greater consumption of inorganic nitrate, since vegetables are the main source of this anion. Dietary nitrate is reduced to nitrite by commensal bacteria in the mouth, which in turn leads to increased circulatory nitrite availability. Nitrite can form nitric oxide by several pathways promoting a reduction in the vascular tone and lower blood pressure. This study tested whether vegetarians have higher concentrations of nitrite in saliva and plasma, and lower blood pressure and resting metabolic rate (RMR), due to higher intakes of nitrate, compared to omnivores. Following a non-randomized, cross-over and single-blinded design we measured dietary nitrate intake, blood pressure and RMR in young and healthy vegetarians (n = 22) and omnivores (n = 19) with similar characteristics after using placebo or antibacterial mouthwash for a week to inhibit oral bacteria. Additionally, we analyzed salivary and plasma nitrate and nitrite concentrations, as well as the oral nitrate-reduction rate and oral microbiome in both groups. Dietary nitrate intake in vegetarians (97 ± 79 mg/day) was not statistically different (P > 0.05) to omnivores (78 ± 47 mg/day). Salivary and plasma nitrate and nitrite concentrations were similar after placebo mouthwash in both groups (P > 0.05). The oral nitrate-reducing capacity, abundance of oral bacterial species, blood pressure and RMR were also similar between vegetarians and omnivores (P > 0.05). Antibacterial mouthwash significantly decreased abundance of oral nitrate-reducing bacterial species in vegetarians ( _ 16.9%; P < 0.001) and omnivores ( _ 17.4%; P < 0.001), which in turn led to a significant reduction of the oral nitrate-reducing capacity in vegetarians (-78%; P < 0.001) and omnivores (-85%; P < 0.001). However, this did not lead to a significant increase in blood pressure and RMR in either groups (P > 0.05). These findings suggest that vegetarian diets may not alter nitrate and nitrite homeostasis, or the oral microbiome, compared to an omnivore diet. Additionally, inhibition of oral nitrite synthesis for a week with antibacterial mouthwash did not cause a significant raise in blood pressure and RMR in healthy, young individuals independent of diet.",2019,Salivary and plasma nitrate and nitrite concentrations were similar after placebo mouthwash in both groups (P > 0.05).,['young and healthy vegetarians (n\u202f=\u202f22) and omnivores (n\u202f=\u202f19) with similar characteristics after using'],"['inorganic nitrate', 'placebo or antibacterial mouthwash']","['nitrate and nitrite homeostasis', 'oral nitrate-reducing capacity, abundance of oral bacterial species, blood pressure and RMR', 'vascular tone and lower blood pressure', 'blood pressure and RMR', 'Salivary and plasma nitrate and nitrite concentrations', 'salivary and plasma nitrate and nitrite concentrations, as well as the oral nitrate-reduction rate and oral microbiome', 'abundance of oral nitrate-reducing bacterial species', 'blood pressure levels', 'blood pressure, resting metabolic rate and the oral microbiome', 'concentrations of nitrite in saliva and plasma, and lower blood pressure and resting metabolic rate (RMR', 'Dietary nitrate intake', 'dietary nitrate intake, blood pressure and RMR']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0042441', 'cui_str': 'Vegetarians'}, {'cui': 'C0562693', 'cui_str': 'Omnivore (organism)'}]","[{'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0279516', 'cui_str': 'Anti-Bacterial Agents'}, {'cui': 'C0026647', 'cui_str': 'Oral Rinse'}]","[{'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0028137', 'cui_str': 'Nitrites'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0427757', 'cui_str': 'Dipstick test of nitrite concentration'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}]",,0.0277587,Salivary and plasma nitrate and nitrite concentrations were similar after placebo mouthwash in both groups (P > 0.05).,"[{'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Ashworth', 'Affiliation': 'Institute of Health & Community, University of Plymouth, Plymouth, PL4 8AA, UK.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Cutler', 'Affiliation': 'Institute of Health & Community, University of Plymouth, Plymouth, PL4 8AA, UK.'}, {'ForeName': 'Garry', 'Initials': 'G', 'LastName': 'Farnham', 'Affiliation': 'Peninsula Medical School, University of Plymouth, Plymouth, PL4 8AA, UK.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Liddle', 'Affiliation': 'School of Social Sciences, Bishop Grosseteste University, Lincolnshire, LN1 3DY, UK; Institute for Clinical Exercise and Health Science, University of the West of Scotland, South Lanarkshire, G72 0LH, UK.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Burleigh', 'Affiliation': 'Institute for Clinical Exercise and Health Science, University of the West of Scotland, South Lanarkshire, G72 0LH, UK.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Rodiles', 'Affiliation': 'School of Biological and Marine Sciences, University of Plymouth, Plymouth, PL4 8AA, UK.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Sillitti', 'Affiliation': 'CNR-Institute for Agricultural and Forest Systems in the Mediterranean, Catania, 95128, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Kiernan', 'Affiliation': 'Peninsula Medical School, University of Plymouth, Plymouth, PL4 8AA, UK.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'Institute of Health & Community, University of Plymouth, Plymouth, PL4 8AA, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Hickson', 'Affiliation': 'Institute of Health & Community, University of Plymouth, Plymouth, PL4 8AA, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Easton', 'Affiliation': 'Institute for Clinical Exercise and Health Science, University of the West of Scotland, South Lanarkshire, G72 0LH, UK.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Bescos', 'Affiliation': 'Institute of Health & Community, University of Plymouth, Plymouth, PL4 8AA, UK. Electronic address: raul.bescos@plymouth.ac.uk.'}]",Free radical biology & medicine,['10.1016/j.freeradbiomed.2019.05.010']
690,32132009,"Impact of a Telephonic Intervention to Improve Diabetes Control on Health Care Utilization and Cost for Adults in South Bronx, New York.","OBJECTIVE


Self-management education and support are essential for improved diabetes control. A 1-year randomized telephonic diabetes self-management intervention (Bronx A1C) among a predominantly Latino and African American population in New York City was found effective in improving blood glucose control. To further those findings, this current study assessed the intervention's impact in reducing health care utilization and costs over 4 years.
RESEARCH DESIGN AND METHODS


We measured inpatient ( n  = 816) health care utilization for Bronx A1C participants using an administrative data set containing all hospital discharges for New York State from 2006 to 2014. Multilevel mixed modeling was used to assess changes in health care utilization and costs between the telephonic diabetes intervention (Tele/Pr) arm and print-only (PrO) control arm.
RESULTS


During follow-up, excess relative reductions in all-cause hospitalizations for the Tele/Pr arm compared with PrO arm were statistically significant for odds of hospital use (odds ratio [OR] 0.89; 95% CI 0.82, 0.97;  P  < 0.01), number of hospital stays (rate ratio [RR] 0.90; 95% CI 0.81, 0.99;  P  = 0.04), and hospital costs (RR 0.90; 95% CI 0.84, 0.98;  P  = 0.01). Reductions in hospital use and costs were even stronger for diabetes-related hospitalizations. These outcomes were not significantly related to changes observed in hemoglobin A 1c  during individuals' participation in the 1-year intervention.
CONCLUSIONS


These results indicate that the impact of the Bronx A1C intervention was not just on short-term improvements in glycemic control but also on long-term health care utilization. This finding is important because it suggests the benefits of the intervention were long-lasting with the potential to not only reduce hospitalizations but also to lower hospital-associated costs.",2020,"These outcomes were not significantly related to changes observed in hemoglobin A 1c  during individuals' participation in the 1-year intervention.
","['predominantly Latino and African American population in New York City', 'Adults in South Bronx, New York', 'inpatient ( n  = 816) health care utilization for Bronx A1C participants using an administrative data set containing all hospital discharges for New York State from 2006 to 2014']","['Bronx A1C intervention', 'Telephonic Intervention', 'telephonic diabetes intervention (Tele/Pr) arm and print-only control (PrO) arm', 'telephonic diabetes self-management intervention (Bronx A1C']","['Health Care Utilization and Cost', 'hospital use and costs', 'number of hospital stays', 'blood glucose control', 'glycemic control', 'health care utilization and costs', 'hospital costs']","[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management'}]","[{'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0206174', 'cui_str': 'Hospital Costs'}]",,0.0255034,"These outcomes were not significantly related to changes observed in hemoglobin A 1c  during individuals' participation in the 1-year intervention.
","[{'ForeName': 'Bahman P', 'Initials': 'BP', 'LastName': 'Tabaei', 'Affiliation': 'New York City Department of Health and Mental Hygiene, New York, NY btabaei@health.nyc.gov.'}, {'ForeName': 'Renata E', 'Initials': 'RE', 'LastName': 'Howland', 'Affiliation': 'New York City Department of Health and Mental Hygiene, New York, NY.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Gonzalez', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Chamany', 'Affiliation': 'New York City Department of Health and Mental Hygiene, New York, NY.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Walker', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Clyde B', 'Initials': 'CB', 'LastName': 'Schechter', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Winfred Y', 'Initials': 'WY', 'LastName': 'Wu', 'Affiliation': 'New York City Department of Health and Mental Hygiene, New York, NY.'}]",Diabetes care,['10.2337/dc19-0954']
691,32222367,"A Prospective, Randomized Trial of Povidone-Iodine 0.6% and Dexamethasone 0.1% Ophthalmic Suspension for Acute Bacterial Conjunctivitis.","PURPOSE


To evaluate the efficacy and safety of a topical ophthalmic suspension combination of povidone-iodine 0.6% (PVP-I) and dexamethasone 0.1% (DEX) for infectious and inflammatory components of bacterial conjunctivitis.
DESIGN


Randomized, double-masked, multicenter, phase 3 clinical trial.
METHODS


Subjects of all ages (those <3 months had to be full-term) with a diagnosis of bacterial conjunctivitis were randomized 3:1:3 to either PVP-I/DEX, PVP-I alone, or placebo. The primary endpoint was clinical resolution in the study eye, and the key secondary efficacy endpoint was bacterial eradication, both at the day 5 visit. Adverse events (AEs) were documented at all visits.
RESULTS


Overall, 753 subjects were randomized (intent-to-treat [ITT] population; PVP-I/DEX [n = 324]; PVP-I [n = 108]; placebo [n = 321]); mean and standard deviation (SD) age was 44.3 (22.9) years, and most were female (61.2%) and white (78.1%). In all treatment groups, mean treatment compliance was >98%. The modified ITT population for the efficacy analysis comprised 526 subjects. In the study eye at the day 5 visit, clinical resolution was achieved by 50.5% (111/220) subjects in the PVP-I/DEX group vs 42.8% (95/222) in the placebo group (P = .127), and bacterial eradication was achieved by 43.3% (94/217) and 46.8% (102/218), respectively (P = .500). Treatment-emergent AEs were experienced by 32.8% (106/323), 39.8% (43/108), and 19.0% (61/321) of subjects in the safety population treated with PVP-I/DEX, PVP-I, and placebo, respectively (most mild in severity).
CONCLUSION


In this study, PVP-I/DEX did not demonstrate additional benefit in clinical efficacy compared with placebo in subjects with bacterial conjunctivitis.",2020,"Treatment-emergent AEs were experienced by 32.8% (106/323), 39.8% (43/108) and 19.0% (61/321) of subjects in the safety population treated with PVP-I/DEX, PVP-I, and placebo, respectively","['Subjects of all ages (those <3 months had to be full-term) with a diagnosis of bacterial conjunctivitis', 'Acute Bacterial Conjunctivitis', 'subjects with bacterial conjunctivitis', '526 subjects', '753 subjects were randomized (intent-to-treat [ITT] population; PVP-I/DEX [N = 324]; PVP-I [N = 108]; placebo [N = 321]); mean (SD) age was 44.3 (22.9) years, and most were female (61.2%) and white (78.1']","['placebo', 'Povidone-Iodine 0.6% and Dexamethasone 0.1% Ophthalmic Suspension', 'PVP-I/DEX, PVP-I 0.6% alone, or placebo', 'DEX', 'topical ophthalmic suspension combination of povidone-iodine (PVP-I; 0.6%) and dexamethasone (DEX']","['bacterial eradication', 'efficacy and safety', 'Adverse events (AEs', 'clinical resolution', 'mean treatment compliance', 'clinical resolution in the study eye, and the key secondary efficacy endpoint was bacterial eradication']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0009768', 'cui_str': 'Conjunctivitis, Mucopurulent'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517833', 'cui_str': '61.2 (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C4068883', 'cui_str': 'Zero point six'}, {'cui': 'C0976129', 'cui_str': 'dexamethasone 0.1 % Ophthalmic Suspension'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0991532', 'cui_str': 'Ophthalmic Suspension'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4319828', 'cui_str': 'Therapeutic Compliance'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",753.0,0.425662,"Treatment-emergent AEs were experienced by 32.8% (106/323), 39.8% (43/108) and 19.0% (61/321) of subjects in the safety population treated with PVP-I/DEX, PVP-I, and placebo, respectively","[{'ForeName': 'Christopher N', 'Initials': 'CN', 'LastName': 'Ta', 'Affiliation': 'Stanford University School of Medicine, Byers Eye Institute at Stanford, Palo Alto, California, USA. Electronic address: cta@stanford.edu.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Raizman', 'Affiliation': 'Tufts University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Gross', 'Affiliation': 'Department of Ophthalmology, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Sunir', 'Initials': 'S', 'LastName': 'Joshi', 'Affiliation': 'Pinnacle Research Institute, Fort Lauderdale, Florida, USA.'}, {'ForeName': 'Sushanta', 'Initials': 'S', 'LastName': 'Mallick', 'Affiliation': 'Shire, A Takeda Company, Lexington, Massachusetts, USA.'}, {'ForeName': 'Yuemei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Shire, A Takeda Company, Lexington, Massachusetts, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Segal', 'Affiliation': 'Private Practice, Delray Beach, Florida, USA.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.03.018']
692,30538282,Prefronto-cerebellar neuromodulation affects appetite in obesity.,"Human neuroimaging studies have consistently reported changes in cerebellar function and integrity in association with obesity. To date, however, the nature of this link has not been studied directly. Emerging evidence suggests a role for the cerebellum in higher cognitive functions through reciprocal connections with the prefrontal cortex. The purpose of this exploratory study was to examine appetite changes associated with noninvasive prefronto-cerebellar neuromodulation in obesity. Totally, 12 subjects with class I obesity (mean body mass index 32.9 kg/m 2 ) underwent a randomized, single-blinded, sham-controlled, crossover study, during which they received transcranial direct current stimulation ((tDCS); active/sham) aimed at simultaneously enhancing the activity of the prefrontal cortex and decreasing the activity of the cerebellum. Changes in appetite (state and food-cue-triggered) and performance in a food-modified working memory task were evaluated. We found that active tDCS caused an increase in hunger and desire to eat following food-cue exposure. In line with these data, subjects also tended to make more errors during the working memory task. No changes in basic motor performance occurred. This study represents the first demonstration that prefronto-cerebellar neuromodulation can influence appetite in individuals with obesity. While preliminary, our findings support a potential role for prefronto-cerebellar pathways in the behavioral manifestations of obesity.",2019,Changes in appetite (state and food-cue-triggered) and performance in a food-modified working memory task were evaluated.,"['individuals with obesity', '12 subjects with class']","['transcranial direct current stimulation ((tDCS); active/sham', 'active tDCS', 'prefronto-cerebellar neuromodulation', 'Prefronto-cerebellar neuromodulation']","['basic motor performance', 'appetite (state and food-cue-triggered) and performance', 'hunger and desire to eat']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]",12.0,0.0223505,Changes in appetite (state and food-cue-triggered) and performance in a food-modified working memory task were evaluated.,"[{'ForeName': 'Elena M', 'Initials': 'EM', 'LastName': 'Marron', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain. emunozmarr@uoc.edu.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Viejo-Sobera', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Guillem', 'Initials': 'G', 'LastName': 'Cuatrecasas', 'Affiliation': 'Endocrinology Department, Clínica Sagrada Familia. Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Redolar-Ripoll', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Pilar García', 'Initials': 'PG', 'LastName': 'Lorda', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Datta', 'Affiliation': 'Soterix Medical, New York City, NY, USA.'}, {'ForeName': 'Marom', 'Initials': 'M', 'LastName': 'Bikson', 'Affiliation': 'Department of Biomedical Engineering, City College of New York (CCNY), New York, NY, USA.'}, {'ForeName': 'Greta', 'Initials': 'G', 'LastName': 'Magerowski', 'Affiliation': 'Laboratory of Bariatric and Nutritional Neuroscience, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Alonso-Alonso', 'Affiliation': 'Laboratory of Bariatric and Nutritional Neuroscience, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. malonso@bidmc.harvard.edu.'}]",International journal of obesity (2005),['10.1038/s41366-018-0278-8']
693,30568260,Personalized nutrition: pretreatment glucose metabolism determines individual long-term weight loss responsiveness in individuals with obesity on low-carbohydrate versus low-fat diet.,"BACKGROUND/OBJECTIVES


The interaction between fasting plasma glucose (FPG) and fasting insulin (FI) concentrations and diets with different carbohydrate content were studied as prognostic markers of weight loss as recent studies up to 6 months of duration have suggested the importance of these biomarkers.
SUBJECTS/METHODS


This was a retrospective analysis of a clinical trial where participants with obesity were randomized to an ad libitum low-carbohydrate diet or a low-fat diet with low energy content (1200-1800 kcal/day [≈ 5.0-7.5 MJ/d]; ≤ 30% calories from fat) for 24 months. Participants were categorized (pretreatment) as normoglycemic (FPG < 5.6 mmol/L) or prediabetic (FPG ≥ 5.6-6.9 mmol/L) and further stratified by median FI. Linear mixed models were used to examine outcomes by FPG and FI values.
RESULTS


After 2 years, participants with prediabetes and high FI lost 7.2  kg (95% CI 2.1;12.2, P = 0.005) more with the low-fat than low-carbohydrate diet, whereas those with prediabetes and low FI tended to lose 6.2  kg (95% CI -0.9;13.3, P = 0.088) more on the low-carbohydrate diet than low-fat diet [mean difference: 13.3 kg (95% CI 4.6;22.0, P = 0.003)]. No differences between diets were found among participants with normoglycemia and either high or low FI (both P ≥ 0.16).
CONCLUSIONS


Fasting plasma glucose and insulin are strong predictors of the weight loss response to diets with different macronutrient composition and might be a useful approach for personalized weight management.",2019,"No differences between diets were found among participants with normoglycemia and either high or low FI (both P ≥ 0.16).
","['Participants were categorized (pretreatment) as normoglycemic (FPG\u2009<\u20095.6\u2009mmol/L) or prediabetic (FPG\u2009≥\u20095.6-6.9\u2009mmol/L) and further stratified by median FI', 'individuals with obesity on low-carbohydrate versus low-fat diet', 'participants with obesity']",['ad libitum low-carbohydrate diet or a low-fat diet with low energy content'],['fasting plasma glucose (FPG) and fasting insulin (FI) concentrations'],"[{'cui': 'C0580545', 'cui_str': 'Blood glucose normal (finding)'}, {'cui': 'C4517794', 'cui_str': '5.6 (qualifier value)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}]","[{'cui': 'C0259836', 'cui_str': 'Diet, Carbohydrate-Restricted'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0200382,"No differences between diets were found among participants with normoglycemia and either high or low FI (both P ≥ 0.16).
","[{'ForeName': 'Mads F', 'Initials': 'MF', 'LastName': 'Hjorth', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Sciences, University of Copenhagen, Copenhagen, Denmark. madsfiil@nexs.ku.dk.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Yishai', 'Initials': 'Y', 'LastName': 'Zohar', 'Affiliation': 'Gelesis, Boston, MA, USA.'}, {'ForeName': 'Lorien E', 'Initials': 'LE', 'LastName': 'Urban', 'Affiliation': 'Gelesis, Boston, MA, USA.'}, {'ForeName': 'R Drew', 'Initials': 'RD', 'LastName': 'Sayer', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Patterson', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Sharon J', 'Initials': 'SJ', 'LastName': 'Herring', 'Affiliation': 'Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Klein', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Babette S', 'Initials': 'BS', 'LastName': 'Zemel', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Foster', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Holly R', 'Initials': 'HR', 'LastName': 'Wyatt', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'James O', 'Initials': 'JO', 'LastName': 'Hill', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}]",International journal of obesity (2005),['10.1038/s41366-018-0298-4']
694,32213141,"Effect of soluble-viscous dietary fibre on coronary heart disease risk score across 3 population health categories: data from randomized, double-blind, placebo-controlled trials.","We applied the Framingham risk equation in healthy, metabolic syndrome, and diabetes populations, following treatment with viscous fibre from konjac-based blend (KBB). KBB yielded reduction in estimated risk score by 16% (1.04 ± 0.03 vs. 0.87 ± 0.04,  p  < 0.01) in type 2 diabetes, 24% (1.08 ± 0.01 vs. 0.82 ± 0.02,  p  < 0.01) in metabolic syndrome, and 25% (1.09 ± 0.05 vs. 0.82 ± 0.06,  p  < 0.01) in healthy individuals. Drivers for decreased risk were improvements in blood cholesterol and systolic blood pressure. The composite coronary heart disease risk across populations was reduced 22% ( p  < 0.01).  Novelty  Viscous fibre from konjac-xanthan reduced 10-year relative coronary heart disease using Framingham Risk Score across the glycemic status spectrum.",2020,The composite coronary heart disease risk across populations was reduced 22% (p<0.01).,['coronary heart disease risk score across three population health categories'],"['viscous fibre from konjac-based blend (KBB', 'soluble-viscous dietary fibre', 'Novelty Bullet: Viscous fibre from konjac-xanthan', 'placebo']","['estimated risk score', 'blood cholesterol and systolic blood pressure']","[{'cui': 'C1277690', 'cui_str': 'Coronary heart disease risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3242284', 'cui_str': 'Population Health'}]","[{'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C1135791', 'cui_str': 'Konjac'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0012173', 'cui_str': 'Dietary Fiber'}, {'cui': 'C0336699', 'cui_str': 'Bullet, device (physical object)'}, {'cui': 'C0078596', 'cui_str': 'xanthan gum'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0518017', 'cui_str': 'Blood cholesterol'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",,0.15749,The composite coronary heart disease risk across populations was reduced 22% (p<0.01).,"[{'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Vuksan', 'Affiliation': ""Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, ON M5B 1W8, Canada.""}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Sievenpiper', 'Affiliation': ""Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, ON M5B 1W8, Canada.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Jovanovski', 'Affiliation': ""Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, ON M5B 1W8, Canada.""}, {'ForeName': 'Alexandra L', 'Initials': 'AL', 'LastName': 'Jenkins', 'Affiliation': ""Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, ON M5B 1W8, Canada.""}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Komishon', 'Affiliation': ""Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, ON M5B 1W8, Canada.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Au-Yeung', 'Affiliation': ""Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, ON M5B 1W8, Canada.""}, {'ForeName': 'Andreea', 'Initials': 'A', 'LastName': 'Zurbau', 'Affiliation': ""Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, ON M5B 1W8, Canada.""}, {'ForeName': 'Hoang V T', 'Initials': 'HVT', 'LastName': 'Ho', 'Affiliation': ""Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, ON M5B 1W8, Canada.""}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, ON M5B 1W8, Canada.""}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Smircic-Duvnjak', 'Affiliation': 'Clinic for Diabetes, Endocrinology & Metabolic Diseases Vuk Vrhovac, University Hospital Merkur, University of Zagreb, School of Medicine, Zagreb, Croatia.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0728']
695,32213209,Comparison of pain levels in fusion prostate biopsy and standard TRUS-Guided biopsy.,"OBJECTIVES


Fusion prostate biopsy (FPB) has recently emerged as a popular and successful biopsy technique on diagnosis of prostate cancer. The aim of this study was to compare the pain levels in TRUS-guided standard 12-core prostate biopsy (SPB) and MpMRI-guided FPB.
MATERIALS AND METHODS


Patients detected with a PI-RADS (Prostate Imaging Reporting and Data System) ≥3 lesion on MpMRI underwent MpMRI-guided FPB (Group I) and the patients who had no suspected lesions or had a PI-RADS<3 lesion on MpMRI underwent TRUS-guided SPB (Group II). Pain assessment was performed using Visual Analog Scale (VAS) five minutes after the procedure. Following the procedure, the patients were asked to indicate the most painful biopsy step among the three steps.
RESULTS


252 patients were included in this study (Group I=159, Group II=93). The mean number of cores and the malignancy detection rate were significantly higher in Group I compared to Group II (p<0.001, p=0.043, respectively). No significant difference was found between the two groups with regard to VAS scores (p=0.070). The most painful part of the whole procedure was revealed to be the insertion of the probe into the rectum. However, no significant difference was found between the two groups with regard to the most painful biopsy step (p=0.140).
CONCLUSION


FPB, with a relatively higher cancer detection rate, leads to the same pain level as SPB although it increases the number of biopsy cores and involves a more complex procedure compared to SPB. Further prospective studies with larger patient series are needed to substantiate our findings.",2020,The mean number of cores and the malignancy detection rate were significantly higher in Group,"['Patients detected with a PI-RADS (Prostate Imaging Reporting and Data System) ≥3 lesion on MpMRI underwent MpMRI-guided FPB (Group I) and the patients who had no suspected lesions or had a PI-RADS<3 lesion on MpMRI underwent TRUS-guided SPB (Group II', '252 patients were included in this study (Group I=159, Group II=93']","['fusion prostate biopsy and standard TRUS-Guided biopsy', 'TRUS-guided standard 12-core prostate biopsy (SPB) and MpMRI-guided FPB', 'https://www.intbrazjurol.com.br/pdf/aop/2019-0154OA.pdf', 'Fusion prostate biopsy (FPB']","['pain levels', 'VAS scores', 'Pain assessment', 'Visual Analog Scale (VAS', 'mean number of cores and the malignancy detection rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0556643', 'cui_str': 'rad (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030198', 'cui_str': 'Nociception Tests'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]",252.0,0.0177572,The mean number of cores and the malignancy detection rate were significantly higher in Group,"[{'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Demirtaş', 'Affiliation': 'Department of Urology, Erciyes University, Kayseri, Turkey.'}, {'ForeName': 'Gökhan', 'Initials': 'G', 'LastName': 'Sönmez', 'Affiliation': 'Department of Urology, Kayseri City Hospital, Kayseri, Turkey.'}, {'ForeName': 'Şevket Tolga', 'Initials': 'ŞT', 'LastName': 'Tombul', 'Affiliation': 'Department of Urology, Erciyes University, Kayseri, Turkey.'}, {'ForeName': 'Türev', 'Initials': 'T', 'LastName': 'Demirtaş', 'Affiliation': 'Department of Medical History and Ethics, Erciyes University, Kayseri, Turkey.'}]",International braz j urol : official journal of the Brazilian Society of Urology,['10.1590/S1677-5538.IBJU.2019.0154']
696,32195949,Time-effective analgesic effect of acupressure ankle strip pressing wrist and ankle acupuncture point on primary dysmenorrhea: Study protocol clinical trial (SPIRIT compliant).,"BACKGROUND


Dysmenorrhea seriously affects the ability of women to perform normal social activities and decreases their quality of life. Primary dysmenorrhea can be effectively treated with acupuncture. Based on the wrist-ankle acupuncture (WAA) theory, we designed a portable WAA point compression treatment strap that treats diseases by automatically applying pressure to acupuncture points. The proposed study aims to evaluate the immediate analgesic effect of the acupressure wrist-ankle strap in patients with primary dysmenorrhea.
METHODS


The study will be a randomized controlled trial conducted from May 1, 2019 to May 30, 2020 that includes 78 students from Shanghai University of Traditional Chinese Medicine who have primary dysmenorrhea and meet the eligibility criteria. Participants will be randomly divided into 2 groups in a 1:1 allocation ratio. The intervention group will use the acupressure wrist-ankle strap equipped with tip compression component parts on the internal side; the control group will use the nonacupressure wrist-ankle strap with the tip compression parts removed. All participants will be treated for 30 minutes on the 1st day of menstruation. The primary outcome is the pain intensity score measured by the visual analog scale. The secondary outcomes are the onset time of analgesia, the pain threshold at Yinlingquan (SP 9), skin temperature at Guanyuan (CV 4), and expectations and satisfaction of patients as investigated via the expectation and treatment credibility scale.
DISCUSSION


This trial will be the 1st study to evaluate the analgesic effect of the acupressure wrist-ankle strap in patients with primary dysmenorrhea. The quality of this study is ensured by the randomization, nonacupressure control, and blinded design. The results may provide evidence for a potential alternative treatment for primary dysmenorrhea and evidence-based proof of the analgesic effect of WAA.",2020,"The proposed study aims to evaluate the immediate analgesic effect of the acupressure wrist-ankle strap in patients with primary dysmenorrhea.
","['2019 to May 30, 2020 that includes 78 students from Shanghai University of Traditional Chinese Medicine who have primary dysmenorrhea and meet the eligibility criteria', 'patients with primary dysmenorrhea', 'primary dysmenorrhea']","['acupuncture', 'acupressure ankle strip pressing wrist and ankle acupuncture point', 'acupressure wrist-ankle strap', 'acupressure wrist-ankle strap equipped with tip compression component parts on the internal side; the control group will use the nonacupressure wrist-ankle strap with the tip compression parts removed']","['onset time of analgesia, the pain threshold at Yinlingquan (SP 9), skin temperature at Guanyuan (CV 4), and expectations and satisfaction of patients as investigated via the expectation and treatment credibility scale', 'quality of life', 'analgesic effect', 'pain intensity score measured by the visual analog scale']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0025124', 'cui_str': 'Zhong Yi Xue'}, {'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea (disorder)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C1321564', 'cui_str': 'Strip'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0001302', 'cui_str': 'Acupoints'}, {'cui': 'C0183631', 'cui_str': 'Strap, device (physical object)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0449719', 'cui_str': 'Part (attribute)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1883720', 'cui_str': 'Removes'}]","[{'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0037294', 'cui_str': 'Skin Temperature'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0222045'}, {'cui': 'C0034380'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",,0.0676772,"The proposed study aims to evaluate the immediate analgesic effect of the acupressure wrist-ankle strap in patients with primary dysmenorrhea.
","[{'ForeName': 'Shu-Jie', 'Initials': 'SJ', 'LastName': 'Zhai', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Ruan', 'Affiliation': 'School of Traditional Chinese Medicine, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'School of Traditional Chinese Medicine, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Lin', 'Affiliation': 'Department of Health Statistics, Naval Medical University.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Xia', 'Affiliation': 'School of Traditional Chinese Medicine, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Fan-Fu', 'Initials': 'FF', 'LastName': 'Fang', 'Affiliation': 'Department of Rehabilitation Medicine, Changhai Hospital, Shanghai, China.'}, {'ForeName': 'Qing-Hui', 'Initials': 'QH', 'LastName': 'Zhou', 'Affiliation': 'School of Traditional Chinese Medicine, Naval Medical University, Shanghai, China.'}]",Medicine,['10.1097/MD.0000000000019496']
697,32195950,Treatment of herpes labialis by photodynamic therapy: Study protocol clinical trial (SPIRIT compliant).,"BACKGROUND


Lesions of herpes labialis are caused by the herpes simplex virus type 1 and cause pain and aesthetic compromise. It is characterized by the formation of small vesicles that coalesce and rupture forming extremely painful ulcers, that evolve to crusts, dry desquamations until their complete remission. Currently the treatment of these lesions is done with acyclovir. Although it diminishes the symptomatology, it causes viral resistance and does not prevent the recurrence of the lesions. It is known that antimicrobial photodynamic therapy (aPDT) has numerous advantages, among them: the reduction of the time of remission, and does not cause resistance. This protocol will determine the effectiveness of PDT in lesions of herpes labialis.
MATERIALS AND METHODS


A total of 30 patients with herpes labialis in the prodromal stage of vesicles, ulcers, and crusts will be selected to participate in the study and randomized into 2 groups: G1 control and G2 experimental. After signing Research Ethics Committee and TA, patients in group G1 will undergo the standard gold treatment for herpes labialis with acyclovir and simulated PDT treatment. Patients in the experimental G2 group will be treated simulating the gold standard treatment of herpes labialis (placebo) and PDT. In all patients, saliva samples will be collected for analysis of cytokines, and will be performed exfoliative cytology in the lesions. The pain will be assessed through a pain scale and a questionnaire of quality of life related to oral health (OHIP-14) will be given to them. Patients will continue to be followed up after 7 days, 1 month, 3 months, and 6 months; if there is a recurrence of the lesion, they will contact the researchers.Clinical registration: clinicaltrials.gov - NCT04037475. Registered on July 2019.",2020,"A total of 30 patients with herpes labialis in the prodromal stage of vesicles, ulcers, and crusts will be selected to participate in the study and randomized into 2 groups: G1 control and G2 experimental.","['30 patients with herpes labialis in the prodromal stage of vesicles, ulcers, and crusts']","['PDT', 'acyclovir and simulated PDT treatment', 'herpes labialis (placebo) and PDT', 'antimicrobial photodynamic therapy (aPDT', 'acyclovir', 'photodynamic therapy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019340', 'cui_str': 'Herpes NOS'}, {'cui': 'C3494361', 'cui_str': 'Prodromal Stage'}, {'cui': 'C0333262', 'cui_str': 'Vesicle (morphologic abnormality)'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0392749', 'cui_str': 'Crusted (qualifier value)'}]","[{'cui': 'C0044588', 'cui_str': 'PDT'}, {'cui': 'C0001367', 'cui_str': 'Acyclovir'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0031740', 'cui_str': 'Photodynamic Therapy'}, {'cui': 'C0627220', 'cui_str': 'Ap(5)dT'}]",[],30.0,0.0841349,"A total of 30 patients with herpes labialis in the prodromal stage of vesicles, ulcers, and crusts will be selected to participate in the study and randomized into 2 groups: G1 control and G2 experimental.","[{'ForeName': 'Andreia', 'Initials': 'A', 'LastName': 'La Selva', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE.'}, {'ForeName': 'Renata Matalon', 'Initials': 'RM', 'LastName': 'Negreiros', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE.'}, {'ForeName': 'Daniela Teixeira', 'Initials': 'DT', 'LastName': 'Bezerra', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE.'}, {'ForeName': 'Ellen Perin', 'Initials': 'EP', 'LastName': 'Rosa', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE.'}, {'ForeName': 'Vanessa Christina Santos', 'Initials': 'VCS', 'LastName': 'Pavesi', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE.'}, {'ForeName': 'Ricardo Scarparo', 'Initials': 'RS', 'LastName': 'Navarro', 'Affiliation': 'Postgraduate Program in Bioengineering and Biomedical Engineering, School of Dentistry, Universidade Brasil.'}, {'ForeName': 'Marina Stella', 'Initials': 'MS', 'LastName': 'Bello-Silva', 'Affiliation': 'International Academy of Lasers in Dentistry.'}, {'ForeName': 'Karen Müller', 'Initials': 'KM', 'LastName': 'Ramalho', 'Affiliation': 'Laser Special Laboratory in Dentistry, LELO, School of Dentistry, University of Sao Paulo.'}, {'ForeName': 'Ana Cecília Corrêa', 'Initials': 'ACC', 'LastName': 'Aranha', 'Affiliation': 'Laser Special Laboratory in Dentistry, LELO, School of Dentistry, University of Sao Paulo.'}, {'ForeName': 'Paulo Henrique', 'Initials': 'PH', 'LastName': 'Braz-Silva', 'Affiliation': 'Division of Pathology, Department of Stomatology, School of Dentistry, University of Sao Paulo.'}, {'ForeName': 'Kristianne Porta Santos', 'Initials': 'KPS', 'LastName': 'Fernandes', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE.'}, {'ForeName': 'Sandra Kalil', 'Initials': 'SK', 'LastName': 'Bussadori', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE.'}, {'ForeName': 'Anna Carolina Ratto Tempestini', 'Initials': 'ACRT', 'LastName': 'Horliana', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE.'}]",Medicine,['10.1097/MD.0000000000019500']
698,32149451,"Emergency Potassium Normalization Treatment Including Sodium Zirconium Cyclosilicate: A Phase II, Randomized, Double-blind, Placebo-controlled Study (ENERGIZE).","OBJECTIVES


Sodium zirconium cyclosilicate (SZC) is a novel, highly selective potassium binder currently approved in the United States and European Union for treatment of hyperkalemia. This pilot evaluation explored the efficacy of SZC with insulin and glucose as hyperkalemia treatment in the emergency department (ED).
METHODS


This exploratory, phase II, multicenter, randomized, double-blind, placebo-controlled study (NCT03337477) enrolled adult ED patients with blood potassium ≥ 5.8 mmol/L. Patients were randomized 1:1 to receive SZC 10 g or placebo, up to three times during a 10-hour period, with insulin and glucose. The primary efficacy outcome was the mean change in serum potassium (sK +  ) from baseline until 4 hours after start of dosing.
RESULTS


Overall, 70 patients were randomized (SZC n = 33, placebo n = 37), of whom 50.0% were male. Their mean (± standard deviation [±SD]) age was 59.0 (±13.8) years and mean initial sK +  was similar between groups (SZC 6.4 mmol/L, placebo 6.5 mmol/L). The least squares mean (±SD) sK +  change from baseline to 4 hours was -0.41 (±0.11) mmol/L and -0.27 (±0.10) mmol/L with SZC and placebo, respectively (difference = -0.13 mmol/L, 95% confidence interval [CI] = -0.44 to 0.17). A greater reduction in mean (±SD) sK +  from baseline occurred with SZC compared with placebo at 2 hours: -0.72 (±0.12) versus -0.36 (±0.11) mmol/L (LSM difference = -0.35 mmol/L, 95% CI = -0.68 to -0.02), respectively. A numerically lower proportion of patients in the SZC group required additional potassium-lowering therapy due to hyperkalemia at 0 to 4 hours versus placebo (15.6% vs. 30.6%, respectively; odds ratio = 0.40, 95% CI = 0.09 to 1.77). Comparable proportions of patients experienced adverse events in both treatment groups at 0 to 24 hours.
CONCLUSIONS


This pilot study suggested that SZC with insulin and glucose may provide an incremental benefit in the emergency treatment of hyperkalemia over insulin and glucose alone.",2020,A greater reduction in mean sK +  from baseline occurred with SZC compared with placebo at 2 hours: -0.72 (0.12) versus -0.36,"['enrolled adult ED patients with blood potassium', '70 patients were randomized (SZC n = 33; placebo n = 37), of which 50.0% were male']","['SZC 10 g or placebo', 'Emergency Potassium Normalization Treatment Including Sodium Zirconium Cyclosilicate', 'SZC with insulin and glucose', 'placebo', 'Sodium zirconium cyclosilicate (SZC', 'SZC and placebo', 'Placebo']","['adverse events', 'additional potassium-lowering therapy due to hyperkalemia', 'mean change in serum potassium (sK +  ', 'mean sK ', 'least squares mean (SD) sK +  change']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0853173', 'cui_str': 'Blood potassium'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4045824', 'cui_str': 'sodium zirconium cyclosilicate'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0020461', 'cui_str': 'Hyperpotassemia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",70.0,0.712986,A greater reduction in mean sK +  from baseline occurred with SZC compared with placebo at 2 hours: -0.72 (0.12) versus -0.36,"[{'ForeName': 'W Frank', 'Initials': 'WF', 'LastName': 'Peacock', 'Affiliation': 'From the, Baylor College of Medicine, Ben Taub General Hospital, Houston, TX.'}, {'ForeName': 'Zubaid', 'Initials': 'Z', 'LastName': 'Rafique', 'Affiliation': 'From the, Baylor College of Medicine, Ben Taub General Hospital, Houston, TX.'}, {'ForeName': 'Konstantin', 'Initials': 'K', 'LastName': 'Vishnevskiy', 'Affiliation': 'the, First Pavlov State, Medical University of St. Petersburg, St. Petersburg, Russia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Michelson', 'Affiliation': 'the, Department of Emergency Medicine, Texas Tech University Health Sciences Center, El Paso, TX.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Vishneva', 'Affiliation': ""the, Scientific Centre of Children's Health, Russian Academy of Medical Science, Moscow, Russia.""}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Zvereva', 'Affiliation': 'the, Scientific Research Institution for Complex Issues of Cardiovascular Disease, Kemerovo Medical University, Kemerovo, Russia.'}, {'ForeName': 'Rajaa', 'Initials': 'R', 'LastName': 'Nahra', 'Affiliation': 'AstraZeneca, Gaithersburg, MD.'}, {'ForeName': 'Dao', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': 'and the, Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.13954']
699,32216143,"Effects of Narrative Exposure Therapy on Posttraumatic Stress Disorder, Depression, and Insomnia in Traumatized North Korean Refugee Youth.","Refugees affected by multiple traumatic stressors are at high risk for developing trauma-related mental disorders, including posttraumatic stress disorder (PTSD), depression, and insomnia, which is sometimes overlooked. The present study examined the effectiveness of narrative exposure therapy (NET) on trauma-related symptoms in a sample of North Korean refugee youth. We focused on sleep patterns in addition to changes in symptom severity for PTSD, depression, and internalizing and externalizing symptoms. North Korean refugee youth (N = 20) with PTSD were assigned to either an NET-based treatment group or a control group, which consisted of treatment as usual (TAU). There were clinically significant reductions in PTSD, depression, and internalizing and externalizing symptoms for the NET group, Hedges' g = 3.6, but not the TAU group. The change in diagnostic status for PTSD was more notable for participants in the NET group compared to the TAU group. Of note, NET also produced a significant improvement in insomnia symptoms and sleep quality, Hedges' g = 2.1. The substantial recovery regarding overall posttraumatic symptoms in the NET group was observed 2 weeks after the end of treatment and remained stable at 6-month follow-up. The results of the present study suggest that NET may be a treatment option for traumatized North Korean refugee youth and may also be effective for the treatment of sleep problems that arise from traumatic experiences.",2020,"There were clinically significant reductions in PTSD, depression, and internalizing and externalizing symptoms for the NET group, Hedges' g = 3.6, but not the TAU group.","['Traumatized North Korean Refugee Youth', 'trauma-related symptoms in a sample of North Korean refugee youth', 'North Korean refugee youth (N = 20) with PTSD']","['NET', 'narrative exposure therapy (NET', 'NET-based treatment group or a control group, which consisted of treatment as usual (TAU', 'Narrative Exposure Therapy']","['symptom severity for PTSD, depression, and internalizing and externalizing symptoms', 'diagnostic status for PTSD', 'PTSD, depression, and internalizing and externalizing symptoms', 'Posttraumatic Stress Disorder, Depression, and Insomnia', 'overall posttraumatic symptoms', 'insomnia symptoms and sleep quality']","[{'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",20.0,0.0228226,"There were clinically significant reductions in PTSD, depression, and internalizing and externalizing symptoms for the NET group, Hedges' g = 3.6, but not the TAU group.","[{'ForeName': 'Jinme K', 'Initials': 'JK', 'LastName': 'Park', 'Affiliation': 'Department of Psychology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Jinah', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Counseling, Kyonggy University, Suwon, Republic of Korea.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Elbert', 'Affiliation': 'Department of Psychology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Seog Ju', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}]",Journal of traumatic stress,['10.1002/jts.22492']
700,32216149,The Impact of Depression Severity on Treatment Outcomes Among Older Male Combat Veterans with Posttraumatic Stress Disorder.,"Posttraumatic stress disorder (PTSD) and depression are highly comorbid within the veteran population. Research studies have yielded divergent findings regarding the effect of depression on PTSD treatment outcomes. The present study investigated the influence of pretreatment depression severity on PTSD and depression symptom trajectories among 85 older (i.e., ≥ 60 years) male veterans with military-related PTSD who received either prolonged exposure or relaxation training as part of a randomized controlled trial. Participants were categorized as having no/mild depression (n = 23) or moderate/severe depression (n = 62). The PTSD Checklist (PCL-S) and Patient Health Questionnaire (PHQ-9) were completed at pretreatment, each of 12 therapy sessions, posttreatment, and 6-month follow-up, for a total of up to 15 data points per participant. Multilevel modeling (MLM) was used to evaluate the impact of pretreatment depression severity on piecewise symptom trajectories (i.e., active treatment and follow-up periods) over time and to determine whether treatment condition moderated the trajectories. The final MLM results showed significant main effects of depression severity on PCL-S scores, B = 10.84, p = .043 and PHQ-9 scores, B = 7.09, p = .001, over time. No significant interactions emerged for either the PCL-S or PHQ-9, indicating that although older veterans with more severe depression endorsed higher PTSD and depression scores across time, the symptom trajectories were not moderated by depression severity, treatment condition, or their interaction.",2020,"The final MLM results showed significant main effects of depression severity on PCL-S scores, B = 10.84, p = .043 and PHQ-9 scores, B = 7.09, p = .001, over time.","['Older Male Combat Veterans with Posttraumatic Stress Disorder', 'Participants were categorized as having no/mild depression (n = 23) or moderate/severe depression (n = 62', '85 older (i.e., ≥ 60 years) male veterans with military-related PTSD who received either']","['prolonged exposure or relaxation training', 'Multilevel modeling (MLM']","['depression severity on PCL-S scores', 'PTSD Checklist (PCL-S) and Patient Health Questionnaire (PHQ-9']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0588006', 'cui_str': 'Mild depression (disorder)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0588008', 'cui_str': 'Severe depression (disorder)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0282333', 'cui_str': 'Relaxation Therapy'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}]",85.0,0.00894826,"The final MLM results showed significant main effects of depression severity on PCL-S scores, B = 10.84, p = .043 and PHQ-9 scores, B = 7.09, p = .001, over time.","[{'ForeName': 'Kristen H', 'Initials': 'KH', 'LastName': 'Walter', 'Affiliation': 'Veterans Affairs (VA) San Diego Healthcare System, San Diego, California, USA.'}, {'ForeName': 'Lisa H', 'Initials': 'LH', 'LastName': 'Glassman', 'Affiliation': 'Veterans Medical Research Foundation, San Diego, California, USA.'}, {'ForeName': 'Stephanie Y', 'Initials': 'SY', 'LastName': 'Wells', 'Affiliation': 'Veterans Affairs (VA) San Diego Healthcare System, San Diego, California, USA.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Thorp', 'Affiliation': 'Veterans Affairs (VA) San Diego Healthcare System, San Diego, California, USA.'}, {'ForeName': 'Leslie A', 'Initials': 'LA', 'LastName': 'Morland', 'Affiliation': 'Veterans Affairs (VA) San Diego Healthcare System, San Diego, California, USA.'}]",Journal of traumatic stress,['10.1002/jts.22503']
701,32216150,Posttraumatic Stress Disorder and Childhood Traumatic Loss: A Secondary Analysis of Symptom Severity and Treatment Outcome.,"Loss is a commonly experienced traumatic event among children. Although the experience of loss can potentially lead to posttraumatic stress symptoms (PTSS), little is known about PTSS levels after traumatic loss versus other traumatic events. We investigated data from a randomized controlled trial (RCT) on trauma-focused cognitive behavioral therapy (TF-CBT) versus a waitlist condition for children with PTSS. In a secondary analysis, we compared participants who reported traumatic loss as their index event (n = 23) to those who reported the two most frequently reported index events in the RCT: sexual abuse (SA; n = 59) and physical violence (PV; n = 55). The index event was rated according to the participants' most distressing traumatic event reported on the Clinician-Administered PTSD Scale for Children and Adolescents. Participants who experienced traumatic loss reported fewer PTSS and better general functioning than those who reported SA. A subgroup RCT (n = 19) revealed TF-CBT to be highly effective in reducing PTSS in cases of traumatic loss, d = 1.69. The effect sizes for PTSS indicated that all three trauma groups benefited from TF-CBT. In the waitlist group, PTSS symptoms improved for SA and PV, ds = 0.76 and 0.98, respectively, but not for traumatic loss, d = 0.23. These findings suggest that TF-CBT is a feasible and promising treatment for children who experience PTSS after traumatic loss. The results are limited by the post hoc quality of the analyses and lack of a measure of grief in the RCT.",2020,"In the waitlist group, PTSS symptoms improved for SA and PV, ds = 0.76 and 0.98, respectively, but not for traumatic loss, d = 0.23.","['children with PTSS', 'Posttraumatic Stress Disorder and Childhood Traumatic Loss', 'children who experience PTSS after traumatic loss']","['cognitive behavioral therapy (TF-CBT', 'TF-CBT']","['PTSS symptoms', 'traumatic loss']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0259766', 'cui_str': 'Traumatic acquired absence (morphologic abnormality)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0259766', 'cui_str': 'Traumatic acquired absence (morphologic abnormality)'}]",59.0,0.0700977,"In the waitlist group, PTSS symptoms improved for SA and PV, ds = 0.76 and 0.98, respectively, but not for traumatic loss, d = 0.23.","[{'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Unterhitzenberger', 'Affiliation': 'Department of Psychology, Catholic University Eichstätt-Ingolstadt, Eichstätt, Germany.'}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Sachser', 'Affiliation': 'Clinic for Child and Adolescent Psychiatry/Psychotherapy, Ulm University, Ulm, Germany.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Rosner', 'Affiliation': 'Department of Psychology, Catholic University Eichstätt-Ingolstadt, Eichstätt, Germany.'}]",Journal of traumatic stress,['10.1002/jts.22499']
702,32222849,Correlates of Physical Activity and Cardiorespiratory Fitness in Racially and Ethnically Diverse People with Serious Mental Illness in Supportive Housing.,"We examined demographic, health, and mental health correlates of physical activity and cardiorespiratory fitness (CRF) in racially and ethnically diverse people with serious mental illness (SMI) living in supportive housing. We used baseline data from 314 people with SMI enrolled in a randomized effectiveness trial of a peer-led healthy lifestyle intervention. Sedentary behavior and physical activity were measured with the International Physical Activity Questionnaire. CRF was measured with the 6-min walking test (6MWT). Correlates were identified via ordinary least squares and logistic regressions. Participants were mostly male and racial/ethnic minorities. Thirty-four percent engaged in at least 150-min-per-week of at least moderate-intensity physical activity. On average, participants walked 316.8 m in the 6MWT. Our models show that physical activity and CRF were not evenly distributed in racially and ethnically diverse people with SMI and are associated with multiple demographic, mental health, and health factors. Our findings suggest subgroups and factors that can be targeted to develop health interventions to improve the physical health of people with SMI.",2020,"Our models show that physical activity and CRF were not evenly distributed in racially and ethnically diverse people with SMI and are associated with multiple demographic, mental health, and health factors.","['Racially and Ethnically Diverse People with Serious Mental Illness in Supportive Housing', 'Participants were mostly male and racial/ethnic minorities', '314 people with SMI enrolled', 'racially and ethnically diverse people with serious mental illness (SMI)\xa0living in supportive housing']",['peer-led healthy lifestyle intervention'],"['International Physical Activity Questionnaire', 'Physical Activity and Cardiorespiratory Fitness', 'Sedentary behavior and physical activity', 'CRF', '6-min walking test (6MWT']","[{'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0020056', 'cui_str': 'Housing'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",314.0,0.0856698,"Our models show that physical activity and CRF were not evenly distributed in racially and ethnically diverse people with SMI and are associated with multiple demographic, mental health, and health factors.","[{'ForeName': 'Leopoldo J', 'Initials': 'LJ', 'LastName': 'Cabassa', 'Affiliation': 'George Warren Brown School of Social Work, Washington University in St. Louis, Campus Box 1196, One Brookings Drive, St. Louis, MO, 63130, USA. ljcabassa@wustl.edu.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Stefancic', 'Affiliation': 'Department of Psychiatry, Columbia University, 1051 Riverside Dr., Rm 3506, New York, NY, 10031, USA.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'George Warren Brown School of Social Work, Washington University in St. Louis, Campus Box 1196, One Brookings Drive, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Shenyang', 'Initials': 'S', 'LastName': 'Guo', 'Affiliation': 'George Warren Brown School of Social Work, Washington University in St. Louis, Campus Box 1196, One Brookings Drive, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Nathaniel Young', 'Initials': 'NY', 'LastName': 'Lu', 'Affiliation': 'Department of Psychiatry, Columbia University, 1051 Riverside Dr., Rm 3506, New York, NY, 10031, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Weatherly', 'Affiliation': 'George Warren Brown School of Social Work, Washington University in St. Louis, Campus Box 1196, One Brookings Drive, St. Louis, MO, 63130, USA.'}]",Community mental health journal,['10.1007/s10597-020-00610-x']
703,32218251,Engagement with a Web-Based Health Promotion Intervention among Vocational School Students: A Secondary User and Usage Analysis.,"Engagement with web-based interventions is both generally low and typically declining. Visits and revisits remain a challenge. Based on log data of a web-based cluster randomized controlled trial conducted in vocational schools, the present secondary analysis aimed to identify influencing factors on initially logging in to a health promotion platform among young adults and to examine the engagement over the course of an eight-week intervention. Data of 336 students (62.2% female, age span 18-25) from two intervention arms (web-based intervention and web-based intervention with an additional initial face-to-face contact) was included. Binary logistic regression and log-data visualization were performed. An additional initial face-to-face contact (odds ratio (OR) = 2.971,  p  = 0.005), female sex (OR = 2.237,  p  = 0.046) and the health-related skill ""dealing with health information"" (OR = 2.179,  p  = 0.030) significantly increased the likelihood of initially logging in. Other variables showed no influence. 16.6% of all potential users logged in at least once, of which 57.4% revisited the platform. Most logins were tracked at the beginning of the intervention and repeated engagement was low. To increase the engagement with web-based interventions, health-related skills should be fostered. In addition, a strategy could be to interlink comparable interventions in vocational schools more regularly with everyday teaching through multi-component interventions.",2020,"An additional initial face-to-face contact (odds ratio (OR) = 2.971,  p  = 0.005), female sex (OR = 2.237,  p  = 0.046) and the health-related skill ""dealing with health information"" (OR = 2.179,  p  = 0.030) significantly increased the likelihood of initially logging in.","['young adults', 'Vocational School Students', '336 students (62.2% female, age span 18-25) from two intervention arms (web-based intervention and web-based intervention with an additional initial face-to-face contact) was included', 'vocational schools']",['Web-Based Health Promotion Intervention'],"['health-related skill ""dealing with health information']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",336.0,0.0433428,"An additional initial face-to-face contact (odds ratio (OR) = 2.971,  p  = 0.005), female sex (OR = 2.237,  p  = 0.046) and the health-related skill ""dealing with health information"" (OR = 2.179,  p  = 0.030) significantly increased the likelihood of initially logging in.","[{'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'Stassen', 'Affiliation': 'Working Group Physical Activity-Related Prevention Research, Institute of Movement Therapy and Movement-oriented Prevention and Rehabilitation, German Sport University Cologne, D-50933 Cologne, Germany.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Grieben', 'Affiliation': 'Department 1: Movement-oriented Prevention and Rehabilitation Sciences, Institute of Movement Therapy and Movement-oriented Prevention and Rehabilitation, German Sport University Cologne, D-50933, Cologne, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Froböse', 'Affiliation': 'Department 1: Movement-oriented Prevention and Rehabilitation Sciences, Institute of Movement Therapy and Movement-oriented Prevention and Rehabilitation, German Sport University Cologne, D-50933, Cologne, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Schaller', 'Affiliation': 'Working Group Physical Activity-Related Prevention Research, Institute of Movement Therapy and Movement-oriented Prevention and Rehabilitation, German Sport University Cologne, D-50933 Cologne, Germany.'}]",International journal of environmental research and public health,['10.3390/ijerph17072180']
704,32218296,The Effect of Nordic Walking Training with Poles with an Integrated Resistance Shock Absorber on the Functional Fitness of Women over the Age of 60.,"Inadequate levels of physical activity among older people lead to a gradual decline in self-reliance and consequent dependence on other people. The aim of the study was to evaluate the impact of Nordic walking training with poles with an integrated resistance shock absorber on the functional fitness of older women. Forty-two women ( M age  = 64.7 ± 3.15 years) were randomly assigned into the experimental group-training with poles with an integrated resistance shock absorber, EG ( n  = 21) and the control active group-training with classic poles, CG ( n  = 21). Functional fitness was measured with the Senior Fitness Test before and after an intervention lasting for 8 weeks (2 training sessions × 75 minutes per week). Two-way ANOVA revealed statistically significant interaction effects for aerobic endurance ( F  = 14.47,  p  < 0.001) and upper body strength ( F  = 5.98,  p  < 0.05), indicating greater improvement in the experimental group. Nordic walking training both with classic poles and with poles with an integrated resistance shock absorber is beneficial for older people and improves functional fitness over a short time period. However, the poles with an integrated resistance shock absorber provide additional resistance effort during marching, which causes increased muscle activation and results in improved muscle strength and aerobic endurance. Based on these results, it can be concluded that this kind of training could be applied in the complex health programs of seniors.",2020,"p  < 0.001) and upper body strength ( F  = 5.98,  p  < 0.05), indicating greater improvement in the experimental group.","['Women over the Age of 60', 'older women', 'Forty-two women ( M age  = 64.7 ± 3.15 years']","['Nordic walking training both with classic poles and with poles with an integrated resistance shock absorber', 'Nordic Walking Training with Poles with an Integrated Resistance Shock Absorber', 'Nordic walking training with poles with an integrated resistance shock absorber', 'experimental group-training with poles with an integrated resistance shock absorber, EG ( n  = 21) and the control active group-training with classic poles, CG']","['upper body strength', 'functional fitness', 'aerobic endurance', 'Functional fitness', 'muscle strength and aerobic endurance']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C4517685', 'cui_str': '3.15'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439658', 'cui_str': 'Classic (qualifier value)'}, {'cui': 'C0337815', 'cui_str': 'Poles (ethnic group)'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C1268087', 'cui_str': 'Upper body'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",,0.0274104,"p  < 0.001) and upper body strength ( F  = 5.98,  p  < 0.05), indicating greater improvement in the experimental group.","[{'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Marciniak', 'Affiliation': 'Poznan University of Physical Education, 61-871 Poznan, Poland.'}, {'ForeName': 'Janusz', 'Initials': 'J', 'LastName': 'Maciaszek', 'Affiliation': 'Poznan University of Physical Education, 61-871 Poznan, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Cyma-Wejchenig', 'Affiliation': 'Poznan University of Physical Education, 61-871 Poznan, Poland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Szeklicki', 'Affiliation': 'Poznan University of Physical Education, 61-871 Poznan, Poland.'}, {'ForeName': 'Zuzanna', 'Initials': 'Z', 'LastName': 'Maćkowiak', 'Affiliation': 'Poznan University of Physical Education, 61-871 Poznan, Poland.'}, {'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Sadowska', 'Affiliation': 'National Research Institute, 03-301 Warsaw, Poland.'}, {'ForeName': 'Rafał', 'Initials': 'R', 'LastName': 'Stemplewski', 'Affiliation': 'Poznan University of Physical Education, 61-871 Poznan, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17072197']
705,32221151,Safety and efficacy data supporting U.S. FDA approval of intracameral phenylephrine and ketorolac 1.0%/0.3% for pediatric cataract surgery: clinical safety and pupil and pain management.,"PURPOSE


To assess the safety of phenylephrine and ketorolac (PE/K) 1.0%/0.3% compared with phenylephrine (PE) 1.0% in children aged 0 to 3 years undergoing cataract surgery. The effect of PE/K to PE on intraoperative pupil diameter and postoperative pain were also compared.
SETTING


Multicenter study in the United States.
DESIGN


Randomized double-masked phase 3 clinical trial.
METHODS


This study was powered to assess safety only. Depending on randomization, 4 mL of PE/K 1.0%/0.3% or PE 1.0% was injected into the surgical irrigation solution. Safety endpoints were assessed up to 90 days postoperatively. From surgical videos, a masked central reader measured the change in pupil diameter from immediately prior to incision to wound closure. Postoperative pain was measured using Alder Hey Triage Pain Score at 3 hours, 6 hours, 9 hours, and 24 hours following wound closure and recorded by parent/caregiver.
RESULTS


Seventy-two patients received masked intervention. There were no notable changes in vital signs or ophthalmological complications in either group. Mean change in pupil diameter was similar between PE/K 1.0%/0.3% and PE 1.0% (mean difference in area under the curve -0.071; P = .599). Postoperative ocular pain scores and overall mean scores were lower in PE/K group at all individual time points, and differences in overall mean scores were statistically significant at 6 and 24 hours (P = .029 and 0.021, respectively).
CONCLUSIONS


PE/K 1.0%/0.3% was safe for use in children and maintained mydriasis during cataract surgery. Postoperative pain levels were lower in the PE/K 1.0%/0.3% group.",2020,"Postoperative ocular pain scores and overall mean scores were lower in PE/K group at all individual time points, and differences in overall mean scores were statistically significant at 6 and 24 hours (P=0.029 and 0.021, respectively).
","['children ages 0 to 3 years undergoing cataract surgery', 'Pediatric Cataract Surgery', 'Seventy-two patients received masked intervention', 'Multicenter study in the United States', 'children and maintained mydriasis during cataract surgery']","['Phenylephrine and ketorolac', 'phenylephrine (PE', 'phenylephrine and ketorolac (PE/K', 'Intracameral Phenylephrine and Ketorolac']","['Mean change in pupil diameter', 'vital signs or ophthalmological complications', 'intraoperative pupil diameter and postoperative pain', 'Alder Hey Triage Pain Score', 'Postoperative pain levels', 'Postoperative ocular pain scores and overall mean scores', 'overall mean scores', 'Postoperative pain']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Study'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0026961', 'cui_str': 'Mydriasis'}]","[{'cui': 'C3833028', 'cui_str': 'Ketorolac / Phenylephrine'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0518766'}, {'cui': 'C2013096', 'cui_str': 'OPHTHALMOLOGICALS'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0330318', 'cui_str': 'Alder'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0151827', 'cui_str': 'Eye pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.30409,"Postoperative ocular pain scores and overall mean scores were lower in PE/K group at all individual time points, and differences in overall mean scores were statistically significant at 6 and 24 hours (P=0.029 and 0.021, respectively).
","[{'ForeName': 'M Edward', 'Initials': 'ME', 'LastName': 'Wilson', 'Affiliation': 'From the Storm Eye Institute (Wilson, Trivedi), Medical University of South Carolina, Charleston, South Carolina, Indiana University (Plager), Indianapolis, Indiana, USA.'}, {'ForeName': 'Rupal H', 'Initials': 'RH', 'LastName': 'Trivedi', 'Affiliation': ''}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Plager', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000194']
706,32219442,Venetoclax plus LDAC for newly diagnosed AML ineligible for intensive chemotherapy: a phase 3 randomized placebo-controlled trial.,"Effective treatment options are limited for patients with acute myeloid leukemia (AML) who cannot tolerate intensive chemotherapy. Adults age ≥18 years with newly diagnosed AML ineligible for intensive chemotherapy were enrolled in this international phase 3 randomized double-blind placebo-controlled trial. Patients (N = 211) were randomized 2:1 to venetoclax (n = 143) or placebo (n = 68) in 28-day cycles, plus low-dose cytarabine (LDAC) on days 1 to 10. Primary end point was overall survival (OS); secondary end points included response rate, transfusion independence, and event-free survival. Median age was 76 years (range, 36-93 years), 38% had secondary AML, and 20% had received prior hypomethylating agent treatment. Planned primary analysis showed a 25% reduction in risk of death with venetoclax plus LDAC vs LDAC alone (hazard ratio [HR], 0.75; 95% confidence interval [CI], 0.52-1.07; P = .11), although not statistically significant; median OS was 7.2 vs 4.1 months, respectively. Unplanned analysis with additional 6-month follow-up demonstrated median OS of 8.4 months for the venetoclax arm (HR, 0.70; 95% CI, 0.50-0.98; P = .04). Complete remission (CR) plus CR with incomplete blood count recovery rates were 48% and 13% for venetoclax plus LDAC and LDAC alone, respectively. Key grade ≥3 adverse events (venetoclax vs LDAC alone) were febrile neutropenia (32% vs 29%), neutropenia (47% vs 16%), and thrombocytopenia (45% vs 37%). Venetoclax plus LDAC demonstrates clinically meaningful improvement in remission rate and OS vs LDAC alone, with a manageable safety profile. Results confirm venetoclax plus LDAC as an important frontline treatment for AML patients unfit for intensive chemotherapy. This trial was registered at www.clinicaltrials.gov as #NCT03069352.",2020,"The CR/CRi rates were 48% and 13% for the Venetoclax plus LDAC arm and LDAC-alone arm, respectively.","['Patients (N=211', 'patients with acute myeloid leukemia (AML) who cannot tolerate intensive chemotherapy', 'Median age was 76 years (range 36-93), 38% had secondary AML, and 20% had prior hypomethylating agent (HMA) treatment', 'Adults ≥18 years with newly diagnosed AML ineligible for intensive chemotherapy', 'patients unfit for intensive chemotherapy', 'patients with untreated AML ineligible for intensive chemotherapy']","['venetoclax plus LDAC', 'placebo', 'placebo (N=68) in 28-day cycles, plus low-dose cytarabine (LDAC', 'venetoclax', 'Venetoclax plus LDAC']","['risk-of-death', 'overall survival (OS); secondary endpoints included response rates, transfusion independence, and event-free survival', 'CR/CRi rates', 'remission rates and OS', 'median OS', 'thrombocytopenia', 'febrile neutropenia', 'neutropenia', 'Key grade ≥3 adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4079830', 'cui_str': 'venetoclax'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",211.0,0.633503,"The CR/CRi rates were 48% and 13% for the Venetoclax plus LDAC arm and LDAC-alone arm, respectively.","[{'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Wei', 'Affiliation': 'The Alfred Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Pau', 'Initials': 'P', 'LastName': 'Montesinos', 'Affiliation': 'Hospital Universitario y Politecnico La Fe, Valencia, Spain.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Ivanov', 'Affiliation': 'Almazov National Medical Research Center, Saint Petersburg, Russia.'}, {'ForeName': 'Courtney D', 'Initials': 'CD', 'LastName': 'DiNardo', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Novak', 'Affiliation': 'Department of Internal Medicine and Hematology, University Hospital Kralovske Vinohrady, Prague, Czech Republic.'}, {'ForeName': 'Kamel', 'Initials': 'K', 'LastName': 'Laribi', 'Affiliation': 'Centre Hospitalier Le Mans, Le Mans, France.'}, {'ForeName': 'Inho', 'Initials': 'I', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Don A', 'Initials': 'DA', 'LastName': 'Stevens', 'Affiliation': 'Norton Cancer Institute, Louisville, KY.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Fiedler', 'Affiliation': 'Hubertus Wald University Cancer Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pagoni', 'Affiliation': 'Evaggelismos General Hospital, Athens Greece.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Samoilova', 'Affiliation': 'Nizhny Novgorod Regional Clinical Hospital, Nizhny Novgorod, Russia.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Achilles', 'Initials': 'A', 'LastName': 'Anagnostopoulos', 'Affiliation': 'George Papanicolaou General Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bergeron', 'Affiliation': ""Centre Intégré Universitaire de Santé et de Services Sociaux de l'Est-de-l'Île-de-Montréal (CIUSSSEMTL), Installation Maisonneuve-Rosemont, Montreal, QC, Canada.""}, {'ForeName': 'Jing-Zhou', 'Initials': 'JZ', 'LastName': 'Hou', 'Affiliation': 'University of Pittsburgh Medical Center Cancer Center, Pittsburgh, PA.'}, {'ForeName': 'Vidhya', 'Initials': 'V', 'LastName': 'Murthy', 'Affiliation': 'Heartlands Hospital, Birmingham, United Kingdom.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Yamauchi', 'Affiliation': 'University of Fukui Hospital, Fukui, Japan.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McDonald', 'Affiliation': 'Netcare Pretoria East Hospital, Pretoria, South Africa.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Chyla', 'Affiliation': 'AbbVie, Inc., North Chicago, IL; and.'}, {'ForeName': 'Sathej', 'Initials': 'S', 'LastName': 'Gopalakrishnan', 'Affiliation': 'AbbVie, Inc., North Chicago, IL; and.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': 'AbbVie, Inc., North Chicago, IL; and.'}, {'ForeName': 'Wellington', 'Initials': 'W', 'LastName': 'Mendes', 'Affiliation': 'AbbVie, Inc., North Chicago, IL; and.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hayslip', 'Affiliation': 'AbbVie, Inc., North Chicago, IL; and.'}, {'ForeName': 'Panayiotis', 'Initials': 'P', 'LastName': 'Panayiotidis', 'Affiliation': 'Laiko General Hospital, National and Kapodistrian University of Athens Medical School, Athens, Greece.'}]",Blood,['10.1182/blood.2020004856']
707,32212829,Stent performance in palliative transhepatic treatment of malignant biliary obstruction: a randomized study comparing covered versus uncovered stents.,,2020,,['malignant biliary obstruction'],[],['Stent performance'],"[{'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]",[],"[{'cui': 'C0038257', 'cui_str': 'Stents'}]",,0.0666687,,"[{'ForeName': 'Aboelyazid', 'Initials': 'A', 'LastName': 'Elkilany', 'Affiliation': 'Department of Diagnostic Medical Imaging and Interventional Radiology, National Liver Institute, Menoufia University, Menoufia, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Alwarraky', 'Affiliation': 'Department of Diagnostic Medical Imaging and Interventional Radiology, National Liver Institute, Menoufia University, Menoufia, Egypt.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Geisel', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Maaly', 'Affiliation': 'Department of Radiology, Faculty of Medicine, Menoufia University, Menoufia, Egypt.'}, {'ForeName': 'Timm', 'Initials': 'T', 'LastName': 'Denecke', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Leipzig University Hospital, Leipzig, Germany.'}]","Acta radiologica (Stockholm, Sweden : 1987)",['10.1177/0284185120911187']
708,32166899,"Angiogenic T cells are decreased in people with type 2 diabetes mellitus and recruited by the dipeptidyl peptidase-4 inhibitor Linagliptin: A subanalysis from a randomized, placebo-controlled trial (RELEASE study).","Angiogenic T (Tang) cells are mediators of vascular repair, and are characterized by surface expression of CXCR4. This receptor for stromal cell-derived factor-1α (SDF-1α) is cleaved by dipeptidyl peptidase-4 (DPP-4). Tang cell levels were investigated in people with type 2 diabetes mellitus (T2DM) compared with matched healthy controls and after treatment with the DPP-4 inhibitor Linagliptin. People with T2DM were randomized to 5 mg/day Linagliptin (n = 20) or placebo (n = 21) for 26 weeks. Tang cell frequency was identified in peripheral blood mononuclear cells (CD3 +  CD31 +  CXCR4 +  ) and levels of endothelial progenitor cells (EPCs) (CD34 +  CD133 +  KDR +  ) were also assessed in whole blood. Circulating Tang cell levels were significantly lower in people with T2DM compared with the healthy control group. SDF-1α levels increased significantly in Linagliptin-treated people with T2DM compared to placebo, and a trend was observed in change of Tang cell levels, while EPC count did not change. In conclusion, circulating Tang cell levels were considerably lower in people with T2DM, while a trend was observed in recruitment of Tang cells after 26 weeks of treatment with Linagliptin. These data suggest that DPP-4 inhibitors may potentially exert beneficial effects on bone marrow-driven vascular repair.",2020,"SDF-1α levels increased significantly in Linagliptin treated people with T2DM compared to placebo, and a trend was observed in change of Tang cells, while EPC count did not change.","['people with type 2 diabetes mellitus', 'people with type 2 diabetes mellitus (T2DM) compared with matched healthy controls (HC) and after treatment with the', 'People with T2DM']","['dipeptidyl peptidase-4 inhibitor Linagliptin', 'Linagliptin', 'placebo', 'DPP4-inhibitor Linagliptin']","['change of Tang cells, while EPC count', 'Circulating Tang cell levels', 'circulating Tang cells', 'SDF-1α levels', 'Angiogenic T (Tang) cells', 'Angiogenic T cells', 'recruitment of Tang cells', 'peripheral blood mononuclear cells (CD3\u2009+\u2009CD31 +  CXCR4 +  ) and levels of endothelial progenitor cells (EPCs, CD34 +  CD133 +  KDR +  ']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}]","[{'cui': 'C1827106', 'cui_str': 'Dipeptidyl-Peptidase 4 Inhibitors'}, {'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0169014', 'cui_str': 'erucylphosphocholine'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}]",,0.187892,"SDF-1α levels increased significantly in Linagliptin treated people with T2DM compared to placebo, and a trend was observed in change of Tang cells, while EPC count did not change.","[{'ForeName': 'Stefanie A', 'Initials': 'SA', 'LastName': 'de Boer', 'Affiliation': 'Department of Internal Medicine, Division of Vascular Medicine, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Reijrink', 'Affiliation': 'Department of Internal Medicine, Division of Vascular Medicine, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Wayel H', 'Initials': 'WH', 'LastName': 'Abdulahad', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Elisa S', 'Initials': 'ES', 'LastName': 'Hoekstra', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Riemer H J A', 'Initials': 'RHJA', 'LastName': 'Slart', 'Affiliation': 'Department of Nuclear Medicine and Molecular Imaging, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen, Netherlands.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Westra', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Douwe J', 'Initials': 'DJ', 'LastName': 'Mulder', 'Affiliation': 'Department of Internal Medicine, Division of Vascular Medicine, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14024']
709,31753727,"Ramucirumab plus docetaxel versus placebo plus docetaxel in patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE): overall survival and updated results of a randomised, double-blind, phase 3 trial.","BACKGROUND


Ramucirumab-an IgG1 vascular endothelial growth factor receptor 2 antagonist-plus docetaxel was previously reported to improve progression-free survival in platinum-refractory, advanced urothelial carcinoma. Here, we report the secondary endpoint of overall survival results for the RANGE trial.
METHODS


We did a randomised, double-blind, phase 3 trial in patients with advanced or metastatic urothelial carcinoma who progressed during or after platinum-based chemotherapy. Patients were enrolled from 124 investigative sites (hospitals, clinics, and academic centres) in 23 countries. Previous treatment with one immune checkpoint inhibitor was permitted. Patients were randomly assigned (1:1) using an interactive web response system to receive intravenous ramucirumab 10 mg/kg or placebo 10 mg/kg volume equivalent followed by intravenous docetaxel 75 mg/m 2  (60 mg/m 2  in Korea, Taiwan, and Japan) on day 1 of a 21-day cycle. Treatment continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met. Randomisation was stratified by geographical region, Eastern Cooperative Oncology Group performance status at baseline, and visceral metastasis. Progression-free survival (the primary endpoint) and overall survival (a key secondary endpoint) were assessed in the intention-to-treat population. The study is registered with ClinicalTrials.gov, NCT02426125; patient enrolment is complete and the last patient on treatment is being followed up for safety issues.
FINDINGS


Between July 20, 2015, and April 4, 2017, 530 patients were randomly allocated to ramucirumab plus docetaxel (n=263) or placebo plus docetaxel (n=267) and comprised the intention-to-treat population. At database lock (March 21, 2018) for the final overall survival analysis, median follow-up was 7·4 months (IQR 3·5-13·9). In our sensitivity analysis of investigator-assessed progression-free survival at the overall survival database lock, median progression-free survival remained significantly improved with ramucirumab compared with placebo (4·1 months [95% CI 3·3-4·8] vs 2·8 months [2·6-2·9]; HR 0·696 [95% CI 0·573-0·845]; p=0·0002). Median overall survival was 9·4 months (95% CI 7·9-11·4) in the ramucirumab group versus 7·9 months (7·0-9·3) in the placebo group (stratified HR 0·887 [95% CI 0·724-1·086]; p=0·25). Grade 3 or worse treatment-related treatment-emergent adverse events in 5% or more of patients and with an incidence more than 2% higher with ramucirumab than with placebo were febrile neutropenia (24 [9%] of 258 patients in the ramucirumab group vs 16 [6%] of 265 patients in the placebo group) and neutropenia (17 [7%] of 258 vs six [2%] of 265). Serious adverse events were similar between groups (112 [43%] of 258 patients in the ramucirumab group vs 107 [40%] of 265 patients in the placebo group). Adverse events related to study treatment and leading to death occurred in eight (3%) patients in the ramucirumab group versus five (2%) patients in the placebo group.
INTERPRETATION


Additional follow-up supports that ramucirumab plus docetaxel significantly improves progression-free survival, without a significant improvement in overall survival, for patients with platinum-refractory advanced urothelial carcinoma. Clinically meaningful benefit might be restricted in an unselected population.
FUNDING


Eli Lilly and Company.",2020,Serious adverse events were similar between groups (112 [43%] of 258 patients in the ramucirumab group vs 107 [40%] of 265 patients in the placebo group).,"['patients with platinum-refractory advanced urothelial carcinoma', 'patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE', '0·887', 'patients with advanced or metastatic urothelial carcinoma who progressed during or after platinum-based chemotherapy', 'Patients were enrolled from 124 investigative sites (hospitals, clinics, and academic centres) in 23 countries', 'Between July 20, 2015, and April 4, 2017, 530 patients']","['docetaxel', 'ramucirumab plus docetaxel', 'Ramucirumab plus docetaxel', 'placebo', 'interactive web response system to receive intravenous ramucirumab 10 mg/kg or placebo 10 mg/kg volume equivalent followed by intravenous docetaxel 75 mg/m 2  (60 mg/m 2  in Korea, Taiwan, and Japan', 'placebo plus docetaxel']","['leading to death', 'Progression-free survival', 'progression-free survival', 'progression-free survival at the overall survival database lock, median progression-free survival', 'overall survival', 'febrile neutropenia', 'neutropenia', 'Median overall survival', 'Serious adverse events', 'Grade 3 or worse treatment-related treatment-emergent adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0007138', 'cui_str': 'Carcinoma, Transitional Cell'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C4288754', 'cui_str': 'Metastatic urothelial carcinoma'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",530.0,0.755003,Serious adverse events were similar between groups (112 [43%] of 258 patients in the ramucirumab group vs 107 [40%] of 265 patients in the placebo group).,"[{'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Petrylak', 'Affiliation': 'Yale School of Medicine, Yale University, New Haven, CT, USA. Electronic address: daniel.petrylak@yale.edu.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'de Wit', 'Affiliation': 'Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}, {'ForeName': 'Kim N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': 'British Columbia Cancer Agency, Vancouver, BC, Canada.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Drakaki', 'Affiliation': 'David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': 'San Camillo and Forlanini Hospitals, Rome, Italy.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Nishiyama', 'Affiliation': 'University of Tsukuba, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Castellano', 'Affiliation': 'Hospital Universitario 12 de Octubre (CiberOnc), Madrid, Spain.'}, {'ForeName': 'Syed A', 'Initials': 'SA', 'LastName': 'Hussain', 'Affiliation': 'Department of Oncology and Metabolism, Medical School, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Fléchon', 'Affiliation': 'Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Aristotelis', 'Initials': 'A', 'LastName': 'Bamias', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Evan Y', 'Initials': 'EY', 'LastName': 'Yu', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Michiel S', 'Initials': 'MS', 'LastName': 'van der Heijden', 'Affiliation': 'Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Matsubara', 'Affiliation': 'National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Alekseev', 'Affiliation': 'P.A. Herzen Moscow Oncological Research Institute, Moscow, Russia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Necchi', 'Affiliation': 'Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Lajos', 'Initials': 'L', 'LastName': 'Géczi', 'Affiliation': 'National Institute of Oncology, Budapest, Hungary.'}, {'ForeName': 'Yen-Chuan', 'Initials': 'YC', 'LastName': 'Ou', 'Affiliation': ""Tungs' Taichung Metro Harbor Hospital, Taichung, Taiwan.""}, {'ForeName': 'Hasan Senol', 'Initials': 'HS', 'LastName': 'Coskun', 'Affiliation': 'Akdeniz University School of Medicine, Antalya, Turkey.'}, {'ForeName': 'Wen-Pin', 'Initials': 'WP', 'LastName': 'Su', 'Affiliation': 'Institute of Clinical Medicine, College of Medicine, National Cheng Kung University & Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Bedke', 'Affiliation': 'Department of Urology, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Gakis', 'Affiliation': 'Department of Urology, University of Tübingen, Tübingen, Germany; Pediatric Urology, Julius Maximillians University, Würzburg, Germany.'}, {'ForeName': 'Ivor J', 'Initials': 'IJ', 'LastName': 'Percent', 'Affiliation': 'Florida Cancer Specialists, Port Charlotte, FL, USA.'}, {'ForeName': 'Jae-Lyun', 'Initials': 'JL', 'LastName': 'Lee', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Tucci', 'Affiliation': 'Division of Medical Oncology, Department of Oncology, University of Turin, San Luigi Gonzaga Hospital, Turin, Italy.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Semenov', 'Affiliation': 'RBHI Ivanovo Regional Oncology Dispensary, Ivanovo, Russia.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Laestadius', 'Affiliation': 'Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'Avivit', 'Initials': 'A', 'LastName': 'Peer', 'Affiliation': 'Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Giampaolo', 'Initials': 'G', 'LastName': 'Tortora', 'Affiliation': 'University of Verona and Azienda Ospedaliera Universitaria Integrata, Verona, Italy.'}, {'ForeName': 'Sufia', 'Initials': 'S', 'LastName': 'Safina', 'Affiliation': 'Tatarstan Regional Cancer Center, Kazan, Russia.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Garcia Del Muro', 'Affiliation': ""Institut Català d'Oncologia L'Hospitalet, Institut d'Investigacio Biomedica de Bellvitge, University of Barcelona, Barcelona, Spain.""}, {'ForeName': 'Alejo', 'Initials': 'A', 'LastName': 'Rodriguez-Vida', 'Affiliation': 'Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Irfan', 'Initials': 'I', 'LastName': 'Cicin', 'Affiliation': 'Trakya University, Edirne, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Harputluoglu', 'Affiliation': 'Inonu University, Malatya, Turkey.'}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Tagawa', 'Affiliation': 'New York-Presbyterian/Weill Cornell Medical Center, New York, NY, USA.'}, {'ForeName': 'Ulka', 'Initials': 'U', 'LastName': 'Vaishampayan', 'Affiliation': 'Karmanos Cancer Institute, Detroit, MI, USA.'}, {'ForeName': 'Jeanny B', 'Initials': 'JB', 'LastName': 'Aragon-Ching', 'Affiliation': 'Inova Schar Cancer Institute, Fairfax, VA, USA.'}, {'ForeName': 'Oday', 'Initials': 'O', 'LastName': 'Hamid', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Astra M', 'Initials': 'AM', 'LastName': 'Liepa', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Sameera', 'Initials': 'S', 'LastName': 'Wijayawardana', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Russo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Walgren', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Annamaria H', 'Initials': 'AH', 'LastName': 'Zimmermann', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Rebecca R', 'Initials': 'RR', 'LastName': 'Hozak', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Bell-McGuinn', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Barts Cancer Institute, Queen Mary University of London, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30668-0']
710,31498030,Treatment-Free Survival: A Novel Outcome Measure of the Effects of Immune Checkpoint Inhibition-A Pooled Analysis of Patients With Advanced Melanoma.,"PURPOSE


Outcome measures that comprehensively capture attributes of immuno-oncology agents, including prolonged treatment-free time and persistent treatment-related adverse events (TRAEs), are needed to complement conventional survival end points.
METHODS


We pooled data from the CheckMate 067 and 069 clinical trials of nivolumab and ipilimumab, as monotherapies or in combination, for patients with advanced melanoma. Treatment-free survival (TFS) was defined as the area between Kaplan-Meier curves for two conventional time-to-event end points, each defined from random assignment: time to immune checkpoint inhibitor (ICI) protocol therapy cessation and time to subsequent systemic therapy initiation or death. TFS was partitioned as time with and without toxicity by a third end point, time to cessation of both ICI therapy and toxicity. Toxicity included persistent and late-onset grade 3 or higher TRAEs. The area under each Kaplan-Meier curve was estimated by the 36-month restricted mean time.
RESULTS


At 36 months, many of the 1,077 patients who initiated ICI therapy were surviving free of subsequent therapy initiation (47% nivolumab plus ipilimumab, 37% nivolumab, 15% ipilimumab). The restricted mean TFS was longer for nivolumab plus ipilimumab (11.1 months) compared with nivolumab (4.6 months; difference, 6.5 months; 95% CI, 5.0 to 8.0 months) or ipilimumab (8.7 months; difference, 2.4 months; 95% CI, 0.8 to 4.1 months); restricted mean TFS represented 31% (3% with and 28% without toxicity), 13% (1% and 11%), and 24% (less than 1% and 23%) of the 36-month period, respectively, in the three treatment groups. TFS without toxicity was longer for nivolumab plus ipilimumab than nivolumab (difference, 6.0 months) or ipilimumab (difference, 1.7 months).
CONCLUSION


The analysis of TFS between ICI cessation and subsequent therapy initiation revealed longer TFS without toxicity for patients with advanced melanoma who received nivolumab plus ipilimumab compared with nivolumab or ipilimumab. Regardless of treatment, a small proportion of the TFS involved grade 3 or higher TRAEs.",2019,"TFS without toxicity was longer for nivolumab plus ipilimumab than nivolumab (difference, 6.0 months) or ipilimumab (difference, 1.7 months).
","['Patients With Advanced Melanoma', 'patients with advanced melanoma']","['nivolumab plus ipilimumab', 'Immune Checkpoint Inhibition', 'ipilimumab', 'nivolumab or ipilimumab', 'nivolumab and ipilimumab', 'TFS']","['Treatment-free survival (TFS', 'TFS without toxicity', 'surviving free of subsequent therapy initiation', 'mean TFS', 'Treatment-Free Survival', 'Toxicity included persistent and late-onset grade 3 or higher TRAEs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",1077.0,0.196501,"TFS without toxicity was longer for nivolumab plus ipilimumab than nivolumab (difference, 6.0 months) or ipilimumab (difference, 1.7 months).
","[{'ForeName': 'Meredith M', 'Initials': 'MM', 'LastName': 'Regan', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Werner', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Sumati', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ.'}, {'ForeName': 'Komal', 'Initials': 'K', 'LastName': 'Gupte-Singh', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ.'}, {'ForeName': 'F Stephen', 'Initials': 'FS', 'LastName': 'Hodi', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kirkwood', 'Affiliation': 'University of Pittsburgh Cancer Institute, Pittsburgh, PA.'}, {'ForeName': 'Harriet M', 'Initials': 'HM', 'LastName': 'Kluger', 'Affiliation': 'Yale Cancer Center, New Haven, CT.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Postow', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Ritchings', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Sznol', 'Affiliation': 'Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Ahmad A', 'Initials': 'AA', 'LastName': 'Tarhini', 'Affiliation': 'Emory University and Winship Comprehensive Cancer Center, Atlanta, GA.'}, {'ForeName': 'Jedd D', 'Initials': 'JD', 'LastName': 'Wolchok', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Atkins', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Washington, DC.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'McDermott', 'Affiliation': 'Harvard Medical School, Boston, MA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00345']
711,31339827,Randomized Trial of Standard Adjuvant Chemotherapy Regimens Versus Capecitabine in Older Women With Early Breast Cancer: 10-Year Update of the CALGB 49907 Trial.,"PURPOSE


Older women with breast cancer remain under-represented in clinical trials. The Cancer and Leukemia Group B 49907 trial focused on women age 65 years and older. We previously reported the primary analysis after a median follow-up of 2.4 years. Standard adjuvant chemotherapy showed significant improvements in recurrence-free survival (RFS) and overall survival compared with capecitabine. We now update results at a median follow-up of 11.4 years.
PATIENTS AND METHODS


Patients age 65 years or older with early breast cancer were randomly assigned to either standard adjuvant chemotherapy (physician's choice of either cyclophosphamide, methotrexate, and fluorouracil or cyclophosphamide and doxorubicin) or capecitabine. An adaptive Bayesian design was used to determine sample size and test noninferiority of capecitabine. The primary end point was RFS.
RESULTS


The design stopped accrual with 633 patients at its first sample size assessment. RFS remains significantly longer for patients treated with standard chemotherapy. At 10 years, in patients treated with standard chemotherapy versus capecitabine, the RFS rates were 56% and 50%, respectively (hazard ratio [HR], 0.80;  P  = .03); breast cancer-specific survival rates were 88% and 82%, respectively (HR, 0.62;  P  = .03); and overall survival rates were 62% and 56%, respectively (HR, 0.84;  P  = .16). With longer follow-up, standard chemotherapy remains superior to capecitabine among hormone receptor-negative patients (HR, 0.66;  P  = .02), but not among hormone receptor-positive patients (HR, 0.89;  P  = .43). Overall, 43.9% of patients have died (13.1% from breast cancer, 16.4% from causes other than breast cancer, and 14.1% from unknown causes). Second nonbreast cancers occurred in 14.1% of patients.
CONCLUSION


With longer follow-up, RFS remains superior for standard adjuvant chemotherapy versus capecitabine, especially in patients with hormone receptor-negative disease. Competing risks in this older population dilute overall survival benefits.",2019,Standard adjuvant chemotherapy showed significant improvements in recurrence-free survival (RFS) and overall survival compared with capecitabine.,"['Older women with breast cancer remain under-represented in clinical trials', 'Older Women With Early Breast Cancer', 'patients with hormone receptor-negative disease', 'women age 65 years and older', '633 patients at its first sample size assessment', 'Patients age 65 years or older with early breast cancer']","['capecitabine', 'standard chemotherapy', 'Standard Adjuvant Chemotherapy Regimens Versus Capecitabine', ""standard adjuvant chemotherapy (physician's choice of either cyclophosphamide, methotrexate, and fluorouracil or cyclophosphamide and doxorubicin) or capecitabine"", 'standard chemotherapy versus capecitabine']","['overall survival rates', 'RFS', 'recurrence-free survival (RFS) and overall survival', 'died', 'RFS rates', 'breast cancer-specific survival rates']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",633.0,0.250812,Standard adjuvant chemotherapy showed significant improvements in recurrence-free survival (RFS) and overall survival compared with capecitabine.,"[{'ForeName': 'Hyman B', 'Initials': 'HB', 'LastName': 'Muss', 'Affiliation': 'University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC.'}, {'ForeName': 'Mei-Yin C', 'Initials': 'MC', 'LastName': 'Polley', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Berry', 'Affiliation': 'Alliance Statistics and Data Center, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Heshan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Constance T', 'Initials': 'CT', 'LastName': 'Cirrincione', 'Affiliation': 'Robert H Lurie Comprehensive Cancer Center, Northwestern University, Evanston, IL.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Theodoulou', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Mauer', 'Affiliation': 'Advocate Illinois Masonic Medical Center, Chicago, IL.'}, {'ForeName': 'Alice B', 'Initials': 'AB', 'LastName': 'Kornblith', 'Affiliation': 'Dana-Farber/Partners CancerCare, Boston, MA.'}, {'ForeName': 'Ann H', 'Initials': 'AH', 'LastName': 'Partridge', 'Affiliation': 'Advocate Illinois Masonic Medical Center, Chicago, IL.'}, {'ForeName': 'Lynn G', 'Initials': 'LG', 'LastName': 'Dressler', 'Affiliation': 'University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC.'}, {'ForeName': 'Harvey J', 'Initials': 'HJ', 'LastName': 'Cohen', 'Affiliation': 'Duke Cancer Institute, Duke University, Durham, NC.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Kartcheske', 'Affiliation': 'Robert H Lurie Comprehensive Cancer Center, Northwestern University, Evanston, IL.'}, {'ForeName': 'Edith A', 'Initials': 'EA', 'LastName': 'Perez', 'Affiliation': 'Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Wolff', 'Affiliation': 'Sidney Kimmel Cancer Center, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Gralow', 'Affiliation': 'University of Washington Seattle Cancer Alliance, Seattle, WA.'}, {'ForeName': 'Harold J', 'Initials': 'HJ', 'LastName': 'Burstein', 'Affiliation': 'Dana-Farber/Partners CancerCare, Boston, MA.'}, {'ForeName': 'Ahmad A', 'Initials': 'AA', 'LastName': 'Mahmood', 'Affiliation': 'Duke Cancer Institute, Duke University, Durham, NC.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Sutton', 'Affiliation': 'Duke Cancer Institute, Duke University, Durham, NC.'}, {'ForeName': 'Gustav', 'Initials': 'G', 'LastName': 'Magrinat', 'Affiliation': 'Cone Health Cancer Center, Greensboro, NC.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Parker', 'Affiliation': 'Moores Cancer Center, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Ronald D', 'Initials': 'RD', 'LastName': 'Hart', 'Affiliation': 'Harold Alfond Center for Cancer Care, Augusta, ME.'}, {'ForeName': 'Debjani', 'Initials': 'D', 'LastName': 'Grenier', 'Affiliation': 'St Boniface General Hospital, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Arti', 'Initials': 'A', 'LastName': 'Hurria', 'Affiliation': 'City of Hope Comprehensive Cancer Center, Duarte, CA.'}, {'ForeName': 'Aminah', 'Initials': 'A', 'LastName': 'Jatoi', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Norton', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Clifford A', 'Initials': 'CA', 'LastName': 'Hudis', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Winer', 'Affiliation': 'Dana-Farber/Partners CancerCare, Boston, MA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Carey', 'Affiliation': 'University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00647']
712,32196514,Results from a cluster-randomized trial to evaluate a microfinance and peer health leadership intervention to prevent HIV and intimate partner violence among social networks of Tanzanian men.,"Despite calls to engage men in HIV and intimate partner violence (IPV) prevention efforts, effective approaches to reach and engage men in low-resource, high-HIV prevalence settings are limited. We identified and engaged social networks of mostly young men in a study designed to evaluate the efficacy of a combined microfinance and peer health leadership intervention to prevent HIV and IPV. We conducted a cluster-randomized trial among 60 social networks locally referred to as ""camps"" within Dar es Salaam, Tanzania. Camps were randomly assigned (1:1) to a microfinance and peer health leadership intervention or a control condition that received a brief delayed intervention after the study's conclusion. Allocation was not masked to participants or researchers. Behavioral assessments were conducted at baseline and 30-months post-intervention launch, with biological samples drawn at 30-months to test for sexually-transmitted infections (STIs). Primary outcomes included prevalence of STIs and past-year IPV perpetration. Secondary outcomes included STI sexual risk behaviors and past-year HIV testing. Proximal intervention targets included inequitable gender norm attitudes and hope. A modified Poisson regression approach was used to estimate intention-to-treat intervention effects on outcomes assessed at the 30-month follow-up. We enrolled 1,258 men within 60 camps. Of these men, 1,029 (81.8%) completed the 30-month follow-up. There were no differences by condition in STI prevalence, IPV perpetration, or sexual risk behaviors at the 30-month follow-up. Intervention participants reported greater levels of past-year HIV testing, controlling for baseline testing (aRR 1.13 95% CI 1.005-1.28). They also reported significantly lower levels of inequitable gender norm attitudes (adjusted effect -0.11, 95% CI -0.21-0.003). We successfully engaged and retained social networks of men in this multilevel intervention study. While we did not see an effect on the primary outcomes, our intervention successfully improved HIV testing and reduced inequitable gender norm attitudes.",2020,"While we did not see an effect on the primary outcomes, our intervention successfully improved HIV testing and reduced inequitable gender norm attitudes.","['mostly young men', '60 social networks locally referred to as ""camps"" within Dar es Salaam, Tanzania', 'HIV and intimate partner violence among social networks of Tanzanian men', 'We enrolled 1,258 men within 60 camps']","['combined microfinance and peer health leadership intervention', 'microfinance and peer health leadership intervention or a control condition that received a brief delayed intervention', 'microfinance and peer health leadership intervention', 'Proximal intervention']","['greater levels of past-year HIV testing, controlling for baseline testing', 'HIV testing and reduced inequitable gender norm attitudes', 'STI prevalence, IPV perpetration, or sexual risk behaviors', 'prevalence of STIs and past-year IPV perpetration', 'STI sexual risk behaviors and past-year HIV testing', 'levels of inequitable gender norm attitudes']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0012054', 'cui_str': ""N',O'-Dibutyryl-cAMP""}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023181', 'cui_str': 'Leadership'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}]",1258.0,0.116286,"While we did not see an effect on the primary outcomes, our intervention successfully improved HIV testing and reduced inequitable gender norm attitudes.","[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Maman', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, United States of America.'}, {'ForeName': 'Marta I', 'Initials': 'MI', 'LastName': 'Mulawa', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Balvanz', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, United States of America.'}, {'ForeName': 'H Luz', 'Initials': 'HL', 'LastName': 'McNaughton Reyes', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, United States of America.'}, {'ForeName': 'Mrema N', 'Initials': 'MN', 'LastName': 'Kilonzo', 'Affiliation': 'Department of Psychiatry and Mental Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Thespina J', 'Initials': 'TJ', 'LastName': 'Yamanis', 'Affiliation': 'School of International Service, American University, Washington, DC, United States of America.'}, {'ForeName': 'Basant', 'Initials': 'B', 'LastName': 'Singh', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, United States of America.'}, {'ForeName': 'Lusajo J', 'Initials': 'LJ', 'LastName': 'Kajula', 'Affiliation': 'Department of Psychiatry and Mental Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}]",PloS one,['10.1371/journal.pone.0230371']
713,30689621,TIMING INFLUENCE ON OUTCOMES OF VITRECTOMY FOR OPEN-GLOBE INJURY: A Prospective Randomized Comparative Study.,"PURPOSE


To compare the impact of surgical timing on anatomical and functional outcomes of vitrectomy for open-globe injury.
METHODS


Fifty-three patients were entered into this prospective open-label study, with 26 patients randomized into early surgery group (vitrectomy conducted within 4 days) and 27 into delayed surgery group (vitrectomy performed between 10-14 days after injury). Six-month data were available for 46 patients and 7 were lost to follow-up. The main outcome measures were incidence of traumatic proliferative vitreoretinopathy assessed intraoperatively and postoperatively, reattachment of retina, eye enucleation, improvement of the best-corrected visual acuity, and complications.
RESULTS


Patient demographics and surgical intervention were similar in both groups. Final analysis of 46 patients demonstrated higher rates of traumatic proliferative vitreoretinopathy assessed both intraoperatively and postoperatively in the delayed group (P = 0.000; P = 0.054). In the early surgery group, 18 of 21 patients had retinal detachment, of which 15 patients (83%) achieved retinal reattachment by the first vitreoretinal surgery, 2 patients (11%) by a second surgery, and 1 (6%) received enucleation. In the delayed surgery group, 22 of 25 patients had retinal detachment. Retinal reattachment was achieved in 7 (32%) and 8 (36%) with the first and the second surgery, respectively, and 7 patients (32%) received enucleation (P = 0.005). In the early surgery group, best-corrected visual acuity improved significantly, moderately, and decreased in 8 patients (38%), 11 eyes (52%) and 2 eyes (10%), respectively. In the delayed surgery group, best-corrected visual acuity improved significantly, moderately, and worsened in 3 eyes (12%), 12 eyes (48%), and 10 eyes (40%) (P = 0.041), respectively. No statistically significant difference was observed in the rate of postoperative complications between the two groups.
CONCLUSION


Early vitrectomy after open-globe injury leads to better anatomical and functional outcomes.",2020,"Retinal reattachment was achieved in 7 (32%) and 8 (36%) with the first and the second surgery, respectively, and 7 patients (32%) received enucleation (P = 0.005).","['46 patients and 7 were lost to follow-up', 'Fifty-three patients']","['vitrectomy', 'early surgery group (vitrectomy conducted within 4 days) and 27 into delayed surgery group (vitrectomy']","['Retinal reattachment', 'rates of traumatic proliferative vitreoretinopathy', 'retinal reattachment', 'incidence of traumatic proliferative vitreoretinopathy assessed intraoperatively and postoperatively, reattachment of retina, eye enucleation, improvement of the best-corrected visual acuity, and complications', 'rate of postoperative complications', 'retinal detachment', 'best-corrected visual acuity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0303134', 'cui_str': '7Be radioisotope'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}]","[{'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0185042', 'cui_str': 'Refixation (procedure)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0242852', 'cui_str': 'Vitreoretinopathy Neovascular Inflammatory'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0197839', 'cui_str': 'Repair of retina for retinal detachment (procedure)'}, {'cui': 'C0015400', 'cui_str': 'Eye Enucleation'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0035305', 'cui_str': 'Retinal Detachment'}]",53.0,0.0629689,"Retinal reattachment was achieved in 7 (32%) and 8 (36%) with the first and the second surgery, respectively, and 7 patients (32%) received enucleation (P = 0.005).","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Ophthalmology, Southwest Hospital, Southwest Eye Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, Southwest Hospital, Southwest Eye Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, Southwest Hospital, Southwest Eye Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Meidong', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': 'Save Sight Institute, Discipline of Clinical Ophthalmology & Eye Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, Southwest Hospital, Southwest Eye Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Ophthalmology, Southwest Hospital, Southwest Eye Hospital, Army Medical University, Chongqing, China.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002447']
714,32195952,Clinical outcomes and cost-effectiveness of massage chair therapy versus basic physiotherapy in lower back pain patients: A randomized controlled trial.,"INTRODUCTION


Low back pain is a chronic recurrent symptom, which can lower the patient's quality of life. With technological development of automated home massage systems, now offers a promising alternative to physiotherapy. However, thus far, the effectiveness of such methods has not been evaluated. We aimed to compare the efficacy and cost-effectiveness of a massage chair with those of conventional physiotherapy for the treatment.
METHODS


This was a randomized controlled trial with a two-group parallel design. Following randomization and allocation, 56 participants were enrolled to receive either physiotherapy (n = 25) or mechanical massage using the massage chair (n = 31). Pain severity was measured using a visual analog scale (VAS) and satisfaction assessed with the McGill Pain Questionnaire (MPQ). Quality of life modification was analyzed using the Functional Rating Index (FRI). Cost-effectiveness was analyzed by comparing the sum of physiotherapy fees and monthly rental fees for chair massage.
RESULTS


Physiotherapy and massage chair were both effective for pain control as assessed with the VAS (P < .001), satisfaction as assessed by MPQ (P < .001) and life quality improvement as assessed by FRI (P < .001) in both groups. Both VAS and FRI scores were significantly higher for physiotherapy than for massage chair (P = .03 and P = .03, respectively). There was no significant difference in MPQ between the two groups. Massage chair therapy was more cost-effective than physiotherapy, at only 60.17% of the physiotherapy cost (P < .001).
CONCLUSIONS


The home massage chair system was cost-effective, but pain control and disability improved more with physiotherapy. However, our results showed that the massage chair is a promising treatment for pain control and quality of life modification, but efficacy is still superior in physiotherapy and the chair is not a replacement for physiotherapy.
TRIAL REGISTRATION


Clinical Research Information Service, KCT0003157. Retrospectively registered August 2, 2018.",2020,"RESULTS


Physiotherapy and massage chair were both effective for pain control as assessed with the VAS (P < .001), satisfaction as assessed by MPQ (P < .001) and life quality improvement as assessed by FRI (P < .001) in both groups.","['56 participants were enrolled to receive either', 'lower back pain patients']","['physiotherapy (n\u200a=\u200a25) or mechanical massage using the massage chair', 'massage chair', 'conventional physiotherapy', 'massage chair therapy versus basic physiotherapy', 'massage chair ', 'Massage chair therapy']","['Functional Rating Index (FRI', 'efficacy and cost-effectiveness', 'cost-effective', 'VAS and FRI scores', 'Pain severity', 'life quality improvement', 'MPQ', 'Cost-effectiveness', 'effective for pain control', 'VAS', 'visual analog scale (VAS) and satisfaction assessed with the McGill Pain Questionnaire (MPQ', 'pain control and disability', 'Quality of life modification']","[{'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0024985', 'cui_str': 'McGill Pain Questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",56.0,0.109563,"RESULTS


Physiotherapy and massage chair were both effective for pain control as assessed with the VAS (P < .001), satisfaction as assessed by MPQ (P < .001) and life quality improvement as assessed by FRI (P < .001) in both groups.","[{'ForeName': 'Seung-Kook', 'Initials': 'SK', 'LastName': 'Kim', 'Affiliation': 'Himchan UHS Spine and Joint Centre, University Hospital Sharjah, Sharjah, United Arab Emirates.'}, {'ForeName': 'Aran', 'Initials': 'A', 'LastName': 'Min', 'Affiliation': 'Medical R&D Center, Bodyfriend, Seoul.'}, {'ForeName': 'Chuljin', 'Initials': 'C', 'LastName': 'Jeon', 'Affiliation': 'Medical R&D Center, Bodyfriend, Seoul.'}, {'ForeName': 'Taeyun', 'Initials': 'T', 'LastName': 'Kim', 'Affiliation': 'Medical R&D Center, Bodyfriend, Seoul.'}, {'ForeName': 'Soohyun', 'Initials': 'S', 'LastName': 'Cho', 'Affiliation': 'Medical R&D Center, Bodyfriend, Seoul.'}, {'ForeName': 'Su-Chan', 'Initials': 'SC', 'LastName': 'Lee', 'Affiliation': 'Joint and Arthritis Research, Orthopedic Surgery, Himchan Hospital, Seoul.'}, {'ForeName': 'Choon-Key', 'Initials': 'CK', 'LastName': 'Lee', 'Affiliation': 'Joint and Arthritis Research, Orthopedic Surgery, Himchan Hospital, Seoul.'}]",Medicine,['10.1097/MD.0000000000019514']
715,32195954,Paraffin therapy induces a decrease in the passive stiffness of gastrocnemius muscle belly and Achilles tendon: A randomized controlled trial.,"BACKGROUND


The purposes of this study were to examine the feasibility of using the MyotonPRO digital palpation device in measuring the passive stiffness of gastrocnemius muscle belly and Achilles tendon; to determine between-days test-retest reliability of MyotonPRO; and to evaluate the acute effect of paraffin therapy on stiffness measurements in healthy participants.
METHODS


It is a randomized controlled trial. Twenty healthy participants (male, n = 10; female, n = 10; total, n = 20) were recruited to evaluate the passive stiffness of gastrocnemius muscle belly and Achilles tendon. Dominant and nondominant legs were randomly divided into an experimental side (20 cases) and a control side (20 cases). The experimental side received 20 minutes of paraffin therapy.
RESULTS


The stiffness of muscle and tendon in the experimental side decreased significantly after paraffin therapy (P < .01), whereas no significant differences in stiffness measurements were found in the control side (P > .05). The passive stiffness of muscle and tendon was positively correlated with the ankle from 30° plantar flexion to10° dorsiflexion for dominant legs. Between-days test-retest reliability in stiffness measurements was high or very high (ICCs were above 0.737).
CONCLUSION


Paraffin therapy induces a decrease in the passive stiffness of gastrocnemius muscle belly and Achilles tendon. Furthermore, the MyotonPRO can reliably determine stiffness measurements.",2020,"The stiffness of muscle and tendon in the experimental side decreased significantly after paraffin therapy (P < .01), whereas no significant differences in stiffness measurements were found in the control side (P > .05).","['Twenty healthy participants (male, n\u200a=\u200a10; female, n\u200a=\u200a10; total, n\u200a=\u200a20', 'healthy participants', 'Dominant and nondominant legs']","['MyotonPRO', 'MyotonPRO digital palpation device', 'paraffin therapy', 'Paraffin therapy']","['passive stiffness of gastrocnemius muscle belly and Achilles tendon', 'stiffness of muscle and tendon', 'passive stiffness of muscle and tendon', 'stiffness measurements']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]","[{'cui': 'C0199220', 'cui_str': 'Digital palpation'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0030415', 'cui_str': 'Paraffin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius Muscle'}, {'cui': 'C0001074', 'cui_str': 'Calcaneal Tendon'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",20.0,0.0282665,"The stiffness of muscle and tendon in the experimental side decreased significantly after paraffin therapy (P < .01), whereas no significant differences in stiffness measurements were found in the control side (P > .05).","[{'ForeName': 'Ya Peng', 'Initials': 'YP', 'LastName': 'Li', 'Affiliation': 'Rehabilitation Therapy Center, Luoyang Orthopedic Hospital of Henan Province, Luoyang.'}, {'ForeName': 'Ya Nan', 'Initials': 'YN', 'LastName': 'Feng', 'Affiliation': 'Rehabilitation Therapy Center, Luoyang Orthopedic Hospital of Henan Province, Luoyang.'}, {'ForeName': 'Chun Long', 'Initials': 'CL', 'LastName': 'Liu', 'Affiliation': 'Clinical Medical College of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Zhi Jie', 'Initials': 'ZJ', 'LastName': 'Zhang', 'Affiliation': 'Rehabilitation Therapy Center, Luoyang Orthopedic Hospital of Henan Province, Luoyang.'}]",Medicine,['10.1097/MD.0000000000019519']
716,32195955,Comparison of preoxygenation with a high-flow nasal cannula and a simple mask before intubation during induction of general anesthesia in patients undergoing head and neck surgery: Study protocol clinical trial (SPIRIT Compliant).,"BACKGROUND


To assess the arterial oxygen partial pressure (PaO2) at defined time points during preoxygenation and to compare high-flow heated humidified nasal oxygenation with standard preoxygenation using oxygen insufflation via a facemask for at least 5 minutes, before intubation during induction of general anesthesia.
METHODS


This randomized, single-blinded, prospective study will be conducted in patients undergoing head and neck surgery. After standard monitoring, the artery catheter at the radial artery or dorsalis pedis artery will be placed and arterial blood gas analysis (ABGA) for baseline values will be performed simultaneously. Each group will be subjected to 1 of 2 preoxygenation methods (high-flow nasal cannula or simple facemask) for 5 minutes, and ABGA will be performed twice. After confirming intubation, we will start mechanical ventilation and check the vital signs and perform the final ABGA.
DISCUSSION


This trial aims to examine the trajectory of PaO2 levels during the whole preoxygenation procedure and after intubation. We hypothesize that preoxygenation with the high-flow nasal cannula will be superior to that with the face mask.
STUDY REGISTRATION


This trial was registered with the Clinical Trial Registry (NCT03896906; ClinicalTrials.gov).",2020,"After standard monitoring, the artery catheter at the radial artery or dorsalis pedis artery will be placed and arterial blood gas analysis (ABGA) for baseline values will be performed simultaneously.",['patients undergoing head and neck surgery'],"['preoxygenation with a high-flow nasal cannula and a simple mask before intubation', 'preoxygenation methods (high-flow nasal cannula or simple facemask']","['PaO2 levels', 'arterial oxygen partial pressure (PaO2']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0185773', 'cui_str': 'Operation on neck'}]","[{'cui': 'C0412792', 'cui_str': 'Preoxygenation (procedure)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C1822073', 'cui_str': 'PaO2'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}]",,0.277144,"After standard monitoring, the artery catheter at the radial artery or dorsalis pedis artery will be placed and arterial blood gas analysis (ABGA) for baseline values will be performed simultaneously.","[{'ForeName': 'Jun-Young', 'Initials': 'JY', 'LastName': 'Jo', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Songpa-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Wook-Jong', 'Initials': 'WJ', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Seungwoo', 'Initials': 'S', 'LastName': 'Ku', 'Affiliation': ''}, {'ForeName': 'Seong-Soo', 'Initials': 'SS', 'LastName': 'Choi', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000019525']
717,32195959,Acupuncture combined with tamsulosin hydrochloride sustained-release capsule in the treatment of chronic prostatitis/chronic pelvic pain syndrome: A study protocol for a randomized controlled trial.,"BACKGROUND


Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a common urinary system disease in men. As part of traditional Traditional Chinese medicine, acupuncture has been widely used in clinical practice. In order to evaluate the exact effect of acupuncture on the clinical efficacy of CP/CPPS, this experiment uses randomized controlled experiments.
METHODS/DESIGN


This pragmatic randomized controlled trial will recruit 166 patients who are diagnosed with CP/CPPS. Simple randomization to conventional drug treatment with a 1:1 allocation ratio will be used. Ten 30-minute acupuncture sessions will be provided to patients assigned to the Intervention group. All participants will continue to receive conventional drug treatment. The selection of outcomes will be evaluated by Health's Symptom Score Index (NIH-CPSI) score at week 4.
DISCUSSION


This trial may provide evidence regarding the clinical effectiveness, safety, and cost-effectiveness of acupuncture for patients with CP/CPPS.
TRIAL REGISTRATION


ClinicalTrials.gov, ChiCTR1900021132, Registered on 29 January 2019.",2020,"The selection of outcomes will be evaluated by Health's Symptom Score Index (NIH-CPSI) score at week 4.
","['166 patients who are diagnosed with CP/CPPS', 'chronic prostatitis/chronic pelvic pain syndrome', 'men', 'Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS', 'patients with CP/CPPS']","['acupuncture', 'Acupuncture combined with tamsulosin hydrochloride sustained-release capsule']","[""Health's Symptom Score Index (NIH-CPSI) score""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085696', 'cui_str': 'Chronic prostatitis (disorder)'}, {'cui': 'C1536168', 'cui_str': 'Chronic pelvic pain syndrome'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0771774', 'cui_str': 'Tamsulosin hydrochloride'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",166.0,0.198694,"The selection of outcomes will be evaluated by Health's Symptom Score Index (NIH-CPSI) score at week 4.
","[{'ForeName': 'Ji-Sheng', 'Initials': 'JS', 'LastName': 'Wang', 'Affiliation': 'Graduate School of Beijing University of Chinese Medicine.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Beijing Fengtai Maternal and Child Health Hospital,Being, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Deng', 'Affiliation': 'Graduate School of Beijing University of Chinese Medicine.'}, {'ForeName': 'Xu-Dong', 'Initials': 'XD', 'LastName': 'Yu', 'Affiliation': 'Graduate School of Beijing University of Chinese Medicine.'}, {'ForeName': 'Bing-Hao', 'Initials': 'BH', 'LastName': 'Bao', 'Affiliation': 'Graduate School of Beijing University of Chinese Medicine.'}, {'ForeName': 'Rui-Jia', 'Initials': 'RJ', 'LastName': 'Liu', 'Affiliation': 'Graduate School of Beijing University of Chinese Medicine.'}, {'ForeName': 'Hai-Song', 'Initials': 'HS', 'LastName': 'Li', 'Affiliation': 'Department of Andrology, Dongzhimen Hospital, Beijing University of Chinese, Beijing, China.'}]",Medicine,['10.1097/MD.0000000000019540']
718,31152039,User-centred clinical decision support to implement emergency department-initiated buprenorphine for opioid use disorder: protocol for the pragmatic group randomised EMBED trial.,"INTRODUCTION


The goal of this trial is to determine whether implementation of a user-centred clinical decision support (CDS) system can increase adoption of initiation of buprenorphine (BUP) into the routine emergency care of individuals with opioid use disorder (OUD).
METHODS


A pragmatic cluster randomised trial is planned to be carried out in 20 emergency departments (EDs) across five healthcare systems over 18 months. The intervention consists of a user-centred CDS integrated into ED clinician electronic workflow and available for guidance to: (1) determine whether patients presenting to the ED meet criteria for OUD, (2) assess withdrawal symptoms and (3) ascertain and motivate patient willingness to initiate treatment. The CDS guides the ED clinician to initiate BUP and facilitate follow-up. The primary outcome is the rate of BUP initiated in the ED. Secondary outcomes are: (1) rates of receiving a referral, (2) fidelity with the CDS and (3) rates of clinicians providing any ED-initiated BUP, referral for ongoing treatment and receiving Drug Addiction Act of 2000 training. Primary and secondary outcomes will be analysed using generalised linear mixed models, with fixed effects for intervention status (CDS vs usual care), prespecified site and patient characteristics, and random effects for study site.
ETHICS AND DISSEMINATION


The protocol has been approved by the Western Institutional Review Board. No identifiable private information will be collected from patients. A waiver of informed consent was obtained for the collection of data for clinician prescribing and other activities. As a minimal risk implementation study of established best practices, an Independent Study Monitor will be utilised in place of a Data Safety Monitoring Board. Results will be reported in ClinicalTrials.gov and published in open-access, peer-reviewed journals, presented at national meetings and shared with the clinicians at participating sites via a broadcast email notification of publications.
TRIAL REGISTRATION NUMBER


NCT03658642; Pre-results.",2019,"The goal of this trial is to determine whether implementation of a user-centred clinical decision support (CDS) system can increase adoption of initiation of buprenorphine (BUP) into the routine emergency care of individuals with opioid use disorder (OUD).
","['20 emergency departments (EDs) across five healthcare systems over 18 months', 'individuals with opioid use disorder (OUD', 'opioid use disorder']","['buprenorphine (BUP', 'buprenorphine']","[' (1) rates of receiving a referral, (2) fidelity with the CDS and (3) rates of clinicians providing any ED-initiated BUP, referral for ongoing treatment and receiving Drug Addiction Act of 2000 training', 'rate of BUP initiated in the ED', 'fixed effects for intervention status (CDS vs usual care), prespecified site and patient characteristics, and random effects for study site']","[{'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}]","[{'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C2585524', 'cui_str': 'Referral for'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1510472', 'cui_str': 'Drug Dependence'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",,0.123887,"The goal of this trial is to determine whether implementation of a user-centred clinical decision support (CDS) system can increase adoption of initiation of buprenorphine (BUP) into the routine emergency care of individuals with opioid use disorder (OUD).
","[{'ForeName': 'Edward R', 'Initials': 'ER', 'LastName': 'Melnick', 'Affiliation': 'Department of Emergency Medicine, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Molly Moore', 'Initials': 'MM', 'LastName': 'Jeffery', 'Affiliation': 'Department of Emergency Medicine, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Dziura', 'Affiliation': 'Department of Emergency Medicine, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Jodi A', 'Initials': 'JA', 'LastName': 'Mao', 'Affiliation': 'Emergency Medicine, Eastern Virginia Medical School, Norfolk, Virginia, USA.'}, {'ForeName': 'Erik P', 'Initials': 'EP', 'LastName': 'Hess', 'Affiliation': 'Department of Emergency Medicine, University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, USA.'}, {'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Platts-Mills', 'Affiliation': 'Department of Emergency Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Yauheni', 'Initials': 'Y', 'LastName': 'Solad', 'Affiliation': 'Information Technology Services, Yale New-Haven Health, New Haven, Connecticut, USA.'}, {'ForeName': 'Hyung', 'Initials': 'H', 'LastName': 'Paek', 'Affiliation': 'Information Technology Services, Yale New-Haven Health, New Haven, Connecticut, USA.'}, {'ForeName': 'Shara', 'Initials': 'S', 'LastName': 'Martel', 'Affiliation': 'Department of Emergency Medicine, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Mehul D', 'Initials': 'MD', 'LastName': 'Patel', 'Affiliation': 'Department of Emergency Medicine, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bankowski', 'Affiliation': 'Department of Emergency Medicine, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': 'Yale Center for Medical Informatics, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Brandt', 'Affiliation': 'Yale Center for Medical Informatics, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': ""D'Onofrio"", 'Affiliation': 'Department of Emergency Medicine, Yale University School of Medicine, New Haven, Connecticut, USA.'}]",BMJ open,['10.1136/bmjopen-2018-028488']
719,32160368,Efficacy of topical dimethyl sulfoxide (DMSO) 50% solution vs tretinoin 0.5% cream in treatment of patients with primary macular amyloidosis: A split-side single-blinded randomized clinical trial.,"Primary localized cutaneous amyloidosis (PLCA) is a recalcitrant sporadic dermatological condition and most treatments have failed so far. We studied the efficacy of topical dimethyl sulfoxide (DMSO) 50% solution in comparison with tretinoin 0.5% cream in treatment of macular amyloidosis. In this split-side within-person single-blinded randomized clinical trial, 18 patients with bilateral macular amyloidosis received topical DMSO 50% solution and tretinoin 0.5% cream either on their right or the left side. The colorimetry, pruritus scoring, and photography were done. A significant pigmentation decline per each follow-up was observed in DMSO group compared to the tretinoin group (tretinoin: -1.31 vs DMSO: -7.34; difference in slopes: -6.03 [95% confidence interval: -12.06 to -0.01], P Interaction  = .049). An insignificant diminution trend in pigmentation was observed for both treatments (P tretinoin  = .672, P DMSO  = .092). Also, both treatments relived itchiness, but DMSO completely dispatched itchiness from the first follow-up (P = .003 for tretinoin and <.0001 for DMSO). In conclusion, our results showed DMSO and tretinoin cream have the positive effect on the both pigmentation and itchiness in PLCA. DMSO may be more beneficial than tretinoin, since DMSO was significantly better in reducing itchiness. More investigations are warranted to provide sufficient evidence.",2020,"An insignificant diminution trend in pigmentation was observed for both treatments (P tretinoin  = .672, P DMSO  = .092).","['18 patients with bilateral macular amyloidosis', 'macular amyloidosis', 'patients with primary macular amyloidosis']","['topical DMSO 50% solution and tretinoin 0.5% cream', 'tretinoin cream', 'tretinoin', 'tretinoin 0.5% cream', 'topical dimethyl sulfoxide (DMSO', 'topical dimethyl sulfoxide (DMSO) 50% solution vs tretinoin 0.5% cream']","['pigmentation decline', 'pigmentation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0002726', 'cui_str': 'Amyloidosis'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0012403', 'cui_str': 'Dimethyl Sulfoxide'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0040845', 'cui_str': 'retinoic acid'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C1378128', 'cui_str': 'Cream'}]","[{'cui': 'C0031911', 'cui_str': 'Pigmentation'}]",18.0,0.23542,"An insignificant diminution trend in pigmentation was observed for both treatments (P tretinoin  = .672, P DMSO  = .092).","[{'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Saki', 'Affiliation': 'Molecular Dermatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Najmeh', 'Initials': 'N', 'LastName': 'Ahramiyanpour', 'Affiliation': 'Dermatology Department, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Heiran', 'Affiliation': 'Student Research Committee, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Shohreh', 'Initials': 'S', 'LastName': 'Alipour', 'Affiliation': 'Department of Quality Control, Faculty of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad Mahdi', 'Initials': 'MM', 'LastName': 'Parvizi', 'Affiliation': 'Molecular Dermatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Dermatologic therapy,['10.1111/dth.13305']
720,32162438,Intralesional zinc sulfate 2% vs intralesional vitamin D in plantar warts: A clinicodermoscopic study.,"Verrucae are benign proliferations seen in skin due to infection with papillomaviruses. There are different treatment strategies for warts but all of these treatments are painful, time consuming, expensive, and recurrence is common. To evaluate and compare the efficacy of intralesional 2% zinc sulfate solution vs vitamin D3 in the treatment of plantar warts, as well as reporting the side effects. This three-armed randomized clinical trial included 105 patients presented with plantar warts divided into three groups, 35 patients per group. The first group received intralesional 2% zinc sulfate, the second group received intralesional 2% vitamin D3, and the third group received normal saline. Four sessions were done, one every 2 weeks. At the end of the study, patients showing complete response were more in zinc group (71.4%), vitamin D3 group (62.9%) compared to saline group (40%). Most of the patients in zinc group showed severe pain during injection (48.6%), most of the patients in vitamin D3 group showed mild pain (80%), while most of the patients in saline group showed no pain (57.1%). Both intralesional 2% zinc sulfate and vitamin D3 are effective in treatment of plantar warts, with zinc sulfate being more effective.",2020,"Most of the patients in zinc group showed severe pain during injection (48.6%), most of the patients in vitamin D3 group showed mild pain (80%), while most of the patients in saline group showed no pain (57.1%).","['105 patients presented with plantar warts divided into three groups, 35 patients per group', 'plantar warts']","['intralesional 2% zinc sulfate, the second group received intralesional 2% vitamin D3, and the third group received normal saline', 'intralesional vitamin D', 'Intralesional zinc sulfate', 'intralesional 2% zinc sulfate and vitamin D3', 'vitamin D3', 'intralesional 2% zinc sulfate solution vs vitamin D3']","['pain', 'mild pain', 'severe pain']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0042548', 'cui_str': 'Verruca plantaris (disorder)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0078794', 'cui_str': 'Zinc Sulfate'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0278138', 'cui_str': 'Mild pain (finding)'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}]",105.0,0.0547558,"Most of the patients in zinc group showed severe pain during injection (48.6%), most of the patients in vitamin D3 group showed mild pain (80%), while most of the patients in saline group showed no pain (57.1%).","[{'ForeName': 'Mahira H', 'Initials': 'MH', 'LastName': 'El Sayed', 'Affiliation': 'Department of Dermatology, Venereology, and Andrology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Fatma S', 'Initials': 'FS', 'LastName': 'Sayed', 'Affiliation': 'Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Afify', 'Affiliation': 'Department of Dermatology, Venereology, and Andrology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}]",Dermatologic therapy,['10.1111/dth.13308']
721,32030863,Association between uric acid levels and cardio-renal outcomes and death in patients with type 2 diabetes: A subanalysis of EMPA-REG OUTCOME.,"In the EMPA-REG OUTCOME trial, we explored the association between pre-randomization uric acid level tertile (<309.30 μmol/L; 309.30 to <387.21 μmol/L; ≥387.21 μmol/L) and cardiovascular (CV) death, hospitalization for heart failure (HHF), HHF or CV death, all-cause mortality, three-point major adverse CV events (MACE), and incident or worsening nephropathy. Patients with type 2 diabetes and CV disease received empagliflozin or placebo. The median baseline plasma uric acid level was 344.98 μmol/L, and patients' baseline characteristics were mainly balanced across tertiles. Baseline uric acid levels were associated with cardio-renal outcomes: in the placebo group, for the highest versus lowest tertile, the multivariable hazard ratios for three-point MACE, HHF or CV death, and incident or worsening nephropathy were 1.22 (95% confidence interval [CI] 0.89-1.67; P = 0.2088), 1.51 (95% CI 1.02-2.23; P = 0.0396) and 1.77 (95% CI 1.33-2.34; P < 0.0001), respectively. When tested as a continuous variable, baseline uric acid was associated with all outcomes in the placebo group. Empagliflozin improved all cardio-renal outcomes across tertiles, with all interaction P values >0.05. Further investigation of these relationships is required.",2020,"Empagliflozin improved all cardio-renal outcomes across tertiles, with all interaction P values > 0.05.","['Patients with type 2 diabetes and CV disease received', 'Patients with Type 2 Diabetes']","['empagliflozin or placebo', 'placebo', 'Empagliflozin']","['cardiovascular (CV) death, hospitalization for heart failure (HHF), HHF or CV death, all-cause mortality, 3-point major adverse CV events (3P-MACE), and incident or worsening nephropathy', 'cardio-renal outcomes', 'Baseline uric acid levels', 'Uric Acid Levels and Cardio-renal Outcomes and Death', 'pre-randomization uric acid levels tertiles', 'multivariable hazard ratios for 3P-MACE, HHF or CV death, and incident or worsening nephropathy', 'Median baseline plasma uric acid']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0857451', 'cui_str': 'Plasma uric acid'}]",,0.353279,"Empagliflozin improved all cardio-renal outcomes across tertiles, with all interaction P values > 0.05.","[{'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""St Michael's Hospital, Division of Cardiac Surgery, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Qiuhe', 'Initials': 'Q', 'LastName': 'Ji', 'Affiliation': ""Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Centre and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Mazer', 'Affiliation': ""St Michael's Hospital, Department of Anaesthesia, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Al-Omran', 'Affiliation': ""St Michael's Hospital, Division of Vascular Surgery, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Würzburg University Clinic, Würzburg, Germany.'}, {'ForeName': 'Anne Pernille', 'Initials': 'AP', 'LastName': 'Ofstad', 'Affiliation': 'Boehringer Ingelheim Norway KS, Asker, Norway.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Zwiener', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany.'}, {'ForeName': 'Jyothis T', 'Initials': 'JT', 'LastName': 'George', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fitchett', 'Affiliation': ""St Michael's Hospital, Division of Cardiology, University of Toronto, Toronto, Ontario, Canada.""}]","Diabetes, obesity & metabolism",['10.1111/dom.13991']
722,32210537,Impact of Intraoperative Infusion and Postoperative PCIA of Dexmedetomidine on Early Breastfeeding After Elective Cesarean Section: A Randomized Double-Blind Controlled Trial.,"Objective


Few studies have investigated the effects of dexmedetomidine (DEX) on breastfeeding after cesarean delivery. A randomized double-blind controlled trial was conducted to investigate whether the administration of DEX, immediately after delivery and for patient-controlled intravenous analgesia (PCIA), can be beneficial for breastfeeding.
Patients and Methods


One hundred sixty parturients scheduled for elective cesarean section under spinal anesthesia were randomly allocated to the DEX group (a loading dose of DEX was pumped at 0.5 μg/kg within 10 min, followed by a further infusion of DEX at 0.5 μg/kg/h until the end of the surgery and PCIA for 2 days with DEX plus sufentanil) or the standard care group (infusion saline intraoperatively, and PCIA for 2 days with sufentanil). The number of days required to switch to exclusive breastfeeding within six weeks of delivery, the time to first lactation and breast milk volume on day 1 and day 2 after delivery were recorded. Recovery quality, comfort, anxiety, depression, postoperative analgesia, and adverse reactions of parturients were also assessed.
Results


Compared with the standard care group, parturients in the DEX group could be converted to exclusive breastfeeding earlier (11 [14] vs 8 [10] days, log-rank P=0.025), the first lactation time was sooner (28.38 [13.82] vs 33.79 [14.85] hrs, P=0.024), and the amount of breast milk on the second day after delivery increased (P=0.012). There was no difference between the two groups in postpartum uterine contraction pain, but postpartum rest and movement VAS scores and recovery quality score in the DEX group were better than those in the standard care group (all P<0.05). Moreover, the hospital anxiety and depression scale and anxiety subscale score on the second day after delivery and the comfort score on the third day after delivery in the DEX group were significantly better than those in the standard care group (5 [5] vs 6 [8], 2 [2] vs 3 [3], 83.58 [6.75] vs 80.48 [6.58]; P=0.013, P=0.005, P=0.006, respectively). The incidence of adverse events, such as bradycardia, vomiting, hypersomnia, hypertension and hypotension, was not significantly different between the DEX and standard care groups (6.9% vs 2.7%, 5.6% vs 13.7%, 4.2% vs 0%, 5.6% vs 2.7%, 11.1% vs 8.2%; P=0.275, P=0.158, P=0.366, P=0.681, P=0.556, respectively), except more parturients experienced nausea in the standard care group than in the DEX group (28.8% vs 11.1%, P=0.012). Furthermore, there was no difference in Neonatal Behavioral Neurological Assessment scores on the first and second days after delivery between the DEX and standard care groups (38 [3] vs 37 [2], 38.5 [2] vs 38 [2]; P=0.173, P=0.312, respectively).
Conclusion


The application of DEX in the perioperative period of cesarean section was not only conducive to the early conversion of infant feeding to exclusive breastfeeding but could also improve the recovery quality and comfort of the parturient, optimize analgesia, shorten the time to first lactation, and increase lactation.
Clinical Trials Registration


NCT03805945.",2020,"There was no difference between the two groups in postpartum uterine contraction pain, but postpartum rest and movement VAS scores and recovery quality score in the DEX group were better than those in the standard care group (all P<0.05).","['Patients and Methods\n\n\nOne hundred sixty parturients scheduled for elective cesarean section under spinal anesthesia', 'After Elective Cesarean Section']","['DEX', 'DEX plus sufentanil', 'dexmedetomidine (DEX', 'patient-controlled intravenous analgesia (PCIA', 'standard care group (infusion saline intraoperatively, and PCIA for 2 days with sufentanil', 'Dexmedetomidine']","['amount of breast milk', 'first lactation time', 'incidence of adverse events, such as bradycardia, vomiting, hypersomnia, hypertension and hypotension', 'postpartum uterine contraction pain, but postpartum rest and movement VAS scores and recovery quality score', 'number of days required to switch to exclusive breastfeeding within six weeks of delivery, the time to first lactation and breast milk volume', 'hospital anxiety and depression scale and anxiety subscale score', 'Early Breastfeeding', 'Recovery quality, comfort, anxiety, depression, postoperative analgesia, and adverse reactions', 'Neonatal Behavioral Neurological Assessment scores', 'nausea']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C0022925', 'cui_str': 'Milk Secretion'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0917799', 'cui_str': 'Hypersomnia'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0042130', 'cui_str': 'Myometrial Contraction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0027853', 'cui_str': 'Neurological Examination'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",160.0,0.0983216,"There was no difference between the two groups in postpartum uterine contraction pain, but postpartum rest and movement VAS scores and recovery quality score in the DEX group were better than those in the standard care group (all P<0.05).","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, People's Republic of China.""}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Fang', 'Affiliation': ""Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan, Hubei, People's Republic of China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': ""Department of Anesthesiology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, People's Republic of China.""}, {'ForeName': 'Xiaotong', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': ""Department of Anesthesiology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, People's Republic of China.""}, {'ForeName': 'Yutong', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': ""Department of Anesthesiology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, People's Republic of China.""}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Yan', 'Affiliation': ""Department of Anesthesiology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, People's Republic of China.""}]","Drug design, development and therapy",['10.2147/DDDT.S241153']
723,32133780,Maternal cardiac function in women at high risk for pre-eclampsia treated with 150 mg aspirin or placebo: an observational study.,"OBJECTIVE


To compare maternal haemodynamics in women at low and high risk for preterm pre-eclampsia (PE), and between those at high risk who are randomised to aspirin or placebo.
DESIGN


Prospective, longitudinal observational study.
SETTING


Maternity units in six UK hospitals.
POPULATION


Women participating in the Aspirin for Prevention of Preterm Pre-eclampsia (ASPRE) trial. The population comprised three groups of women: low risk for preterm PE (n = 1362), high risk for preterm PE treated with aspirin (n = 208) and high risk for preterm PE on placebo (n = 220).
METHODS


Women had four visits during pregnancy: 11-14, 19-24, 30-34, and 35-37 weeks' gestation. Blood pressure was measured with a device validated for pregnancy, and PE and maternal haemodynamics were assessed with a bioreactance monitor at each visit. A multilevel linear mixed-effects analysis was performed to examine longitudinal changes of maternal haemodynamic variables, controlling for demographic characteristics, past medical history and medication use.
MAIN OUTCOME MEASURES


Longitudinal changes of cardiac output (CO), mean arterial pressure (MAP), and peripheral vascular resistance (PVR).
RESULTS


The low-risk group demonstrated the expected changes with an increase in CO and reduction in MAP and PVR, with a quadratic change across gestation. In contrast, the high-risk groups had a declining CO, and higher MAP and PVR during pregnancy. The administration of aspirin did not appear to affect maternal haemodynamics.
CONCLUSIONS


Women screened as high risk for preterm PE have a pathological cardiac adaptation to pregnancy and the prophylactic use of aspirin (150 mg oral daily from the first trimester) in this group may not alter this haemodynamic profile.
TWEETABLE ABSTRACT


In women at high risk of pre-eclampsia, prophylactic use of aspirin may not alter the impaired maternal cardiac adaptation.",2020,"The administration of aspirin did not appear to affect maternal haemodynamics.
","['Women participating in the Aspirin for Prevention of Preterm Pre-eclampsia (ASPRE) trial', 'Maternity units in six UK hospitals', ""Women had four visits during pregnancy: 11-14, 19-24, 30-34- and 35-37 weeks' gestation"", 'women at high-risk for preeclampsia treated with 150mg', 'women low and high-risk for preterm pre-eclampsia (PE) and between those high-risk randomised to', 'population comprised of three groups of women: low-risk for preterm PE (N=1362), high-risk for preterm PE treated with aspirin (N=208), and high-risk for preterm PE on placebo (N=220']","['aspirin or placebo', 'aspirin', 'Aspirin or placebo']","['CO and reduction in MAP and PVR', 'Blood pressure', 'pregnancy and PE and maternal haemodynamics', 'Maternal cardiac function', 'maternal haemodynamics', 'cardiac output (CO), mean arterial pressure (MAP) and peripheral vascular resistance (PVR']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C1258192', 'cui_str': 'Total Peripheral Resistance'}]",,0.607837,"The administration of aspirin did not appear to affect maternal haemodynamics.
","[{'ForeName': 'H Z', 'Initials': 'HZ', 'LastName': 'Ling', 'Affiliation': ""Fetal Medicine Research Institute, King's College London, London, UK.""}, {'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Jara', 'Affiliation': ""Fetal Medicine Research Institute, King's College London, London, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bisquera', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, London, UK.""}, {'ForeName': 'L C', 'Initials': 'LC', 'LastName': 'Poon', 'Affiliation': ""Fetal Medicine Research Institute, King's College London, London, UK.""}, {'ForeName': 'K H', 'Initials': 'KH', 'LastName': 'Nicolaides', 'Affiliation': ""Fetal Medicine Research Institute, King's College London, London, UK.""}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Kametas', 'Affiliation': ""Fetal Medicine Research Institute, King's College London, London, UK.""}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16193']
724,32216142,Combat-Related Posttraumatic Stress Disorder and Comorbid Major Depression in U.S. Veterans: The Role of Deployment Cycle Adversity and Social Support.,"Posttraumatic stress disorder (PTSD) and major depressive disorder (MDD) commonly co-occur in combat veterans, and this comorbidity has been associated with higher levels of distress and more social and economic costs compared to one disorder alone. In a secondary analysis of a multisite randomized controlled trial of a sample of veterans with combat-related PTSD, we examined the associations among pre-, peri-, and postdeployment adversity, social support, and clinician-diagnosed comorbid MDD. Participants completed the Deployment Risk and Resilience Inventory and the Beck Depression Inventory-II as well as structured clinical interviews for diagnostic status. Among 223 U.S. veterans of the military operations in Iraq and Afghanistan (86.9% male) with primary combat-related PTSD, 69.5% had current comorbid MDD. After adjustment for sex, a linear regression model indicated that more concerns about family disruptions during deployment, f 2  = 0.065; more harassment during deployment, f 2  = 0.020; and lower ratings of postdeployment social support, f 2  = 0.154, were associated with more severe self-reported depression symptoms. Interventions that enhance social support as well as societal efforts to foster successful postdeployment reintegration are critical for reducing the mental health burden associated with this highly prevalent comorbidity in veterans with combat-related PTSD.",2020,"After adjustment for sex, a linear regression model indicated that more concerns about family disruptions during deployment, f 2  = 0.065; more harassment during deployment, f 2  = 0.020; and lower ratings of postdeployment social support, f 2  = 0.154, were associated with more severe self-reported depression symptoms.","['Posttraumatic stress disorder (PTSD) and major depressive disorder (MDD', 'Combat-Related Posttraumatic Stress Disorder and Comorbid Major Depression in U.S. Veterans', 'veterans with combat-related PTSD', '223 U.S. veterans of the military operations in Iraq and Afghanistan (86.9% male) with primary combat-related PTSD, 69.5% had current comorbid MDD']",[],"['Deployment Risk and Resilience Inventory and the Beck Depression Inventory-II', 'severe self-reported depression symptoms']","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0022066', 'cui_str': 'Republic of Iraq'}, {'cui': 'C0001732', 'cui_str': 'Afghanistan'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0161695,"After adjustment for sex, a linear regression model indicated that more concerns about family disruptions during deployment, f 2  = 0.065; more harassment during deployment, f 2  = 0.020; and lower ratings of postdeployment social support, f 2  = 0.154, were associated with more severe self-reported depression symptoms.","[{'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Goetter', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Susanne S', 'Initials': 'SS', 'LastName': 'Hoeppner', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Khan', 'Affiliation': 'San Francisco VA Medical Center, San Francisco, California, USA.'}, {'ForeName': 'Meredith E', 'Initials': 'ME', 'LastName': 'Charney', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Wieman', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Margaret R', 'Initials': 'MR', 'LastName': 'Venners', 'Affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Kimberly M', 'Initials': 'KM', 'LastName': 'Avallone', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Sheila A M', 'Initials': 'SAM', 'LastName': 'Rauch', 'Affiliation': 'VA Atlanta Healthcare System, Atlanta, Georgia, USA.'}, {'ForeName': 'Naomi M', 'Initials': 'NM', 'LastName': 'Simon', 'Affiliation': 'Department of Psychiatry, New York University School of Medicine, New York, New York, USA.'}]",Journal of traumatic stress,['10.1002/jts.22496']
725,31418989,A neurobiological correlate of stress-induced nicotine-seeking behavior among cigarette smokers.,"Stress is known to influence smoking relapse. Experimental studies indicate that acute stress increases nicotine-seeking behavior, yet neurobiological mechanisms remain poorly understood. Herein, we investigated disrupted excitatory neural activity in the dorsolateral prefrontal cortex (dlPFC) as a mechanism of stress-induced nicotine-seeking behavior. Non-treatment-seeking cigarette smokers were screened for psychiatric, medical, and neuroimaging contraindications. Using a double-blind, placebo-controlled, randomized crossover design, participants (N = 21) completed two oral-dosing sessions: stress (yohimbine 54 mg + hydrocortisone 10 mg) vs placebo (lactose 54 mg + lactose 10 mg). During each experimental session, working memory proficiency, dlPFC excitatory neural activity, nicotine-seeking behavior, and subjective effects were measured. dlPFC excitatory neural activity was quantified via glutamate modulation during working memory performance using functional proton magnetic resonance spectroscopy. Nicotine-seeking behavior was assayed using a cigarette puffs vs money choice progressive ratio task. Results indicated that yohimbine + hydrocortisone evoked a sustained physiological stress response (elevated heart rate, blood pressure, saliva cortisol, and saliva α-amylase levels; ps < .05). Relative to placebo levels, acute stress increased nicotine-seeking behavior (ps < .05), disrupted dlPFC glutamate modulation (p = .025), and impaired dlPFC function (working memory proficiency; ps < .05). The stress-induced increase in nicotine-seeking behavior was linearly related to the stress-induced disruption of dlPFC glutamate modulation (R 2   = 0.24-0.37; ps < .05). These findings suggest that disrupted dlPFC excitatory neural activity is a neurobiological correlate of acute stress-induced nicotine-seeking behavior. These findings further emphasize the central role of the dlPFC in regulating drug-seeking behavior. Future studies are needed to evaluate interventions to improve dlPFC resilience to acute stress effects, including neurostimulation, working memory training, and ""anti-stress"" medications.",2020,"Relative to placebo levels, acute stress increased nicotine-seeking behavior (ps < .05), disrupted dlPFC glutamate modulation (p = .025), and impaired dlPFC function (working memory proficiency; ps < .05).","['cigarette smokers', 'participants (N\xa0=\xa021) completed two', 'Non-treatment-seeking cigarette smokers']","['placebo', 'oral-dosing sessions: stress (yohimbine 54\xa0mg\xa0+\xa0hydrocortisone 10\xa0mg) vs placebo (lactose 54\xa0mg\xa0+\xa0lactose', 'yohimbine + hydrocortisone']","['working memory proficiency, dlPFC excitatory neural activity, nicotine-seeking behavior, and subjective effects', 'nicotine-seeking behavior', 'sustained physiological stress response (elevated heart rate, blood pressure, saliva cortisol, and saliva α-amylase levels', 'stress-induced disruption of dlPFC glutamate modulation', 'impaired dlPFC function', 'disrupted dlPFC glutamate modulation']","[{'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0724441', 'cui_str': 'yohimbine'}, {'cui': 'C1603583', 'cui_str': 'Hydrocortisone 10 MG [Cortef]'}, {'cui': 'C0022949', 'cui_str': 'Lactose'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]","[{'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C2350025', 'cui_str': 'Physiological Stress Reactivity'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0201883', 'cui_str': 'Amylase measurement (procedure)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0332453', 'cui_str': 'Disruption (morphologic abnormality)'}, {'cui': 'C0220839', 'cui_str': 'Glutamate'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.0413021,"Relative to placebo levels, acute stress increased nicotine-seeking behavior (ps < .05), disrupted dlPFC glutamate modulation (p = .025), and impaired dlPFC function (working memory proficiency; ps < .05).","[{'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Woodcock', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Stanley', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, Wayne State University School of Medicine, Detroit, Michigan, USA.'}, {'ForeName': 'Vaibhav A', 'Initials': 'VA', 'LastName': 'Diwadkar', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, Wayne State University School of Medicine, Detroit, Michigan, USA.'}, {'ForeName': 'Dalal', 'Initials': 'D', 'LastName': 'Khatib', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, Wayne State University School of Medicine, Detroit, Michigan, USA.'}, {'ForeName': 'Mark K', 'Initials': 'MK', 'LastName': 'Greenwald', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, Wayne State University School of Medicine, Detroit, Michigan, USA.'}]",Addiction biology,['10.1111/adb.12819']
726,31428863,Effects of the nontourniquet combined with controlled hypotension technique on pain and long-term prognosis in elderly patients after total knee arthroplasty: a randomized controlled study.,"PURPOSE


The aim of this study was to confirm the alleviating effects of the nontourniquet technique on the postoperative acute and chronic pain of patients after total knee arthroplasty (TKA).
METHODS


122 elderly patients undergoing TKA were randomly divided into two groups: group T (n = 58) and group H (n = 64). An electronic inflatable tourniquet was used during TKA in group T. The patients in group H received controlled hypotension but without tourniquet use during the operation. The numeric rating scale (NRS) score was used to evaluate pain level on day 1, day 2, day 3 and day 7 after the operation, and the incidence of chronic pain was judged at 3-month and 1-year follow-ups, and functional recovery of the knee joint was estimated by the active range of knee joint motion (AROM) at the same time points. Cognitive function was assessed by the montreal cognitive assessment scale (MoCA) for 7 days after operation.
RESULTS


There were no significant differences in the NRS scores and AROM for 7 days after surgery. The incidence rate of chronic pain in group H (25.0%) was lower than that in group T (41.4%) and the AROM in group H was greater at one year follow-up. The MoCA score in group H was lower than that in group T on day 1 and day 2.
CONCLUSION


The nontourniquet combined with controlled hypotension technique can alleviate chronic pain and promote the long-term rehabilitation of patients after TKA.",2019,"The MoCA score in group H was lower than that in group T on day 1 and day 2.
","['patients after TKA', 'elderly patients after total knee arthroplasty', 'patients after total knee arthroplasty (TKA', '122 elderly patients undergoing TKA']","['nontourniquet combined with controlled hypotension technique', 'nontourniquet technique', 'controlled hypotension technique']","['Cognitive function', 'active range of knee joint motion (AROM', 'montreal cognitive assessment scale (MoCA', 'controlled hypotension', 'incidence rate of chronic pain', 'chronic pain', 'pain level', 'numeric rating scale (NRS) score', 'MoCA score', 'incidence of chronic pain', 'pain and long-term prognosis', 'postoperative acute and chronic pain', 'NRS scores and AROM']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0020650', 'cui_str': 'Hypotension, Induced'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0022745', 'cui_str': 'Superior Tibiofibular Joint'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C3496286'}, {'cui': 'C0222045'}, {'cui': 'C0020650', 'cui_str': 'Hypotension, Induced'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0033325', 'cui_str': 'Prognosis'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",122.0,0.0366645,"The MoCA score in group H was lower than that in group T on day 1 and day 2.
","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Chongqing Medical University, No. 1 Youyi Road, Yuzhong District, Chongqing, China. dongjun441@163.com.'}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Min', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Chongqing Medical University, No. 1 Youyi Road, Yuzhong District, Chongqing, China.'}, {'ForeName': 'Kai-Hua', 'Initials': 'KH', 'LastName': 'He', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Chongqing Medical University, No. 1 Youyi Road, Yuzhong District, Chongqing, China.'}, {'ForeName': 'Li-Hua', 'Initials': 'LH', 'LastName': 'Peng', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Chongqing Medical University, No. 1 Youyi Road, Yuzhong District, Chongqing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Chongqing Medical University, No. 1 Youyi Road, Yuzhong District, Chongqing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Ran', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Chongqing Medical University, No. 1 Youyi Road, Yuzhong District, Chongqing, China.'}]",Journal of anesthesia,['10.1007/s00540-019-02671-z']
727,31435739,Rocuronium Bromide Intravenous Solution Maruishi® is more suitable than ESLAX Intravenous® during rapid-sequence induction of anesthesia.,"PURPOSE


Rocuronium Bromide Intravenous Solution® (Maruishi Pharmaceutical Co., Ltd, Osaka, Japan) is a newly developed generic drug and we have noticed that compared with conventional rocuronium formulations [e.g. Esmeron (Eslax), MSD Co. Ltd., Tokyo, Japan], rocuronium Maruishi appeared to cause less pain or withdrawal movement. The aim of this study was to assess the hypothesis that the injection of rocuronium Maruishi causes less body movement than rocuronium MSD does, during rapid-sequence induction of anesthesia.
METHODS


Sixty patients were allocated randomly to one of two groups. In one group, rocuronium MSD was used and in the other group, rocuronium Maruishi was used. After induction of general anesthesia, a test drug (containing rocuronium) 0.9 mg/kg was injected. Patient's withdrawal movement was graded with the scale. Primary outcome measure was the incidence of moderate or severe movement after the injection of rocuronium. Secondary outcome measure was the degree of movement between the groups.
RESULTS


Moderate or severe withdrawal movement was observed after the injection of rocuronium MSD in 11 of 30 patients (37%) and after the injection of rocuronium Maruishi in 3 of 30 patients (10%). There was a significant difference in the incidence between the groups (P = 0.013, 95% CI for difference 26-28%). The degree of movement was also significantly greater for rocuronium MSD than for rocuronium Maruishi (P = 0.015).
CONCLUSION


Compared with rocuronium MSD, rocuronium Maruishi is more suitable than conventional rocuronium formulations, for rapid-sequence induction of anesthesia.",2019,"Compared with rocuronium MSD, rocuronium Maruishi is more suitable than conventional rocuronium formulations, for rapid-sequence induction of anesthesia.",['Sixty patients'],"['Rocuronium Bromide Intravenous Solution Maruishi®', 'Rocuronium Bromide Intravenous Solution®', 'rocuronium', 'rocuronium MSD, rocuronium Maruishi', 'rocuronium MSD']","['degree of movement between the groups', ""Patient's withdrawal movement"", 'Moderate or severe withdrawal movement', 'degree of movement', 'incidence of moderate or severe movement after the injection of rocuronium']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0069632', 'cui_str': 'rocuronium bromide'}, {'cui': 'C0991514', 'cui_str': 'Intravenous solution (qualifier value)'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}]","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}]",60.0,0.404565,"Compared with rocuronium MSD, rocuronium Maruishi is more suitable than conventional rocuronium formulations, for rapid-sequence induction of anesthesia.","[{'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Tachikawa', 'Affiliation': 'Department of Anesthesiology, Dokkyo Medical University Saitama Medical Center, 2-1-50 Minamikoshigaya, Koshigaya City, 343-8555, Saitama, Japan. tachi@dokkyomed.ac.jp.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Asai', 'Affiliation': 'Department of Anesthesiology, Dokkyo Medical University Saitama Medical Center, 2-1-50 Minamikoshigaya, Koshigaya City, 343-8555, Saitama, Japan.'}, {'ForeName': 'Yasuhisa', 'Initials': 'Y', 'LastName': 'Okuda', 'Affiliation': 'Department of Anesthesiology, Dokkyo Medical University Saitama Medical Center, 2-1-50 Minamikoshigaya, Koshigaya City, 343-8555, Saitama, Japan.'}]",Journal of anesthesia,['10.1007/s00540-019-02673-x']
728,30916714,Efficacy and Tolerability of Adjunctive Intravenous Sodium Nitroprusside Treatment for Outpatients With Schizophrenia: A Randomized Clinical Trial.,"Importance


Antipsychotic medications for the treatment of schizophrenia have limitations, and new treatments are needed. A prior pilot investigation suggested that adjunctive sodium nitroprusside (SNP) administered intravenously had rapid efficacy in the treatment of patients with schizophrenia.
Objective


To determine the efficacy and tolerability of intravenous SNP infused at a rate of 0.5 μg/kg/min for 4 hours in patients with schizophrenia with some degree of treatment resistance.
Design, Setting, and Participants


Multicenter, randomized, double-blind acute treatment study using a sequential parallel comparison design conducted in two 2-week phases at 4 academic medical centers beginning May 20, 2015, and ending March 31, 2017. Participants were adults 18 to 65 years of age with a diagnosis of schizophrenia as confirmed by the Structured Clinical Interview for DSM-IV, taking antipsychotic medication for at least 8 weeks, and had at least 1 failed trial of an antipsychotic medication within the past year. A total of 90 participants consented, 60 participants enrolled, and 52 participants were included in the analyses. A modified intent-to-treat analysis was used.
Interventions


Participants were randomized in a 1:1:1 ratio to 1 of 3 treatment sequences: SNP and SNP, placebo and SNP, and placebo and placebo. The SNP and SNP group received SNP in phase 1 and SNP in phase 2 for the purpose of blinding, but the data from phase 2 were not included in the results. The placebo and SNP group received placebo in phase 1 and SNP in phase 2. If there was no response to placebo in phase 1, data from phase 2 were included in the analyses. The placebo and placebo group received placebo in both phases; if there was no response to placebo in phase 1, data from phase 2 were included in the analyses.
Main Outcomes and Measures


Effectiveness of SNP compared with placebo in improving Positive and Negative Syndrome Scale (PANSS) total, positive, and negative scores across each 2-week phase.
Results


Fifty-two participants (12 women and 40 men) were included in the study. In the SNP and SNP group, the mean (SD) age was 47.1 (10.5) years. In the placebo and SNP group, the mean (SD) age was 45.9 (12.3) years. In the placebo and placebo group, the mean (SD) age was 40.4 (11.0) years. There were no significant differences between the SNP and placebo groups at baseline or in change from baseline for PANSS-total (weighted β = -1.04; z = -0.59; P = .57), PANSS-positive (weighted β = -0.62; z = -0.93; P = .35), or PANSS-negative (weighted β = -0.12; z = -0.19; P = .85) scores. No significant differences in safety or tolerability measures were identified.
Conclusions and Relevance


Although intravenous SNP is well tolerated, it was not an efficacious adjunctive treatment of positive or negative symptoms of psychosis among outpatients with schizophrenia with prior history of treatment resistance.
Trial Registration


ClinicalTrials.gov identifier: NCT02164981.",2019,"There were no significant differences between the SNP and placebo groups at baseline or in change from baseline for PANSS-total (weighted β = -1.04; z = -0.59; P = .57), PANSS-positive (weighted β = -0.62; z = -0.93; P = .35), or PANSS-negative (weighted β = -0.12; z = -0.19; P = .85) scores.","['Fifty-two participants (12 women and 40 men', 'Outpatients With Schizophrenia', 'Participants were adults 18 to 65 years of age with a diagnosis of schizophrenia as confirmed by the Structured Clinical Interview for DSM-IV, taking antipsychotic medication for at least 8 weeks, and had at least 1 failed trial of an antipsychotic medication within the past year', 'outpatients with schizophrenia with prior history of treatment resistance', 'two 2-week phases at 4 academic medical centers beginning May 20, 2015, and ending March 31, 2017', 'A total of 90 participants consented, 60 participants enrolled, and 52 participants were included in the analyses', 'patients with schizophrenia with some degree of treatment resistance', 'patients with schizophrenia']","['placebo', 'adjunctive sodium nitroprusside (SNP', 'Adjunctive Intravenous Sodium Nitroprusside Treatment', 'SNP and SNP, placebo and SNP, and placebo and placebo', 'intravenous SNP', 'SNP']","['safety or tolerability measures', 'Positive and Negative Syndrome Scale (PANSS) total, positive, and negative scores', 'Efficacy and Tolerability', 'efficacy and tolerability']","[{'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C0199182', 'cui_str': 'Taking health history'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0037533', 'cui_str': 'Sodium Nitroprusside'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",60.0,0.278782,"There were no significant differences between the SNP and placebo groups at baseline or in change from baseline for PANSS-total (weighted β = -1.04; z = -0.59; P = .57), PANSS-positive (weighted β = -0.62; z = -0.93; P = .35), or PANSS-negative (weighted β = -0.12; z = -0.19; P = .85) scores.","[{'ForeName': 'Hannah E', 'Initials': 'HE', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Freudenreich', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Xiaoduo', 'Initials': 'X', 'LastName': 'Fan', 'Affiliation': 'Department of Psychiatry, UMass Memorial Health Care and UMass Medical School, Worcester, Massachusetts.'}, {'ForeName': 'Stephen O', 'Initials': 'SO', 'LastName': 'Heard', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, UMass Memorial Health Care and UMass Medical School, Worcester, Massachusetts.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Goff', 'Affiliation': 'Department of Psychiatry, NYU Langone Medical Center, New York, New York.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Petrides', 'Affiliation': 'Department of Psychiatry, The Zucker Hillside Hospital, Glen Oaks, New York.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Harrington', 'Affiliation': 'Department of Psychiatry, UMass Memorial Health Care and UMass Medical School, Worcester, Massachusetts.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kane', 'Affiliation': 'Department of Psychiatry, The Zucker Hillside Hospital, Glen Oaks, New York.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Judge', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Hoeppner', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Roy H', 'Initials': 'RH', 'LastName': 'Perlis', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.0151']
729,32209798,Effect of 12-Week Interventions Involving Nordic Walking Exercise and a Modified Diet on the Anthropometric Parameters and Blood Lipid Profiles in Overweight and Obese Ex-Coal Miners.,"BACKGROUND


Overweight and obesity after retirement are likely to be caused by unhealthy eating habits and the energy intake exceeding the energy expenditure.
OBJECTIVES


This study was designed to assess the effects of two 12-week interventions involving, respectively, either regular physical activity or a modified lower-calorie diet on the anthropometric parameters and blood lipid profiles in overweight and obese retired miners with lipid disorders.
DESIGN


The study participants (n = 30, aged 58.7 ± 4.1 years, body height 174.8 ± 7.3 cm, body weight 96.6 ± 13.9 kg) were randomly assigned to 2 intervention groups: the Nordic walking group (NW), which exercised with intensity from 60 to 70% of participants' maximal heart rates for 1 h 3 times a week, and the modified diet group (MD). Modification of the diet consisted of reducing the daily energy intake by 30%, increasing the dietary content of mono- and polyunsaturated fatty acids and dietary fiber, and reducing the proportion of saturated fatty acids. The variables assessed at baseline and after 6 and 12 weeks were: anthropometric parameters (body weight, fat mass content [FM], fat percentage [BF], BMI, waist circumference [WC], hip circumference [HC], and waist-to-hip ratio [WHR]) and blood lipid indicators (total cholesterol [TC], triglycerides [TG], low density lipoprotein cholesterol [LDL-C], and high density lip-oprotein cholesterol [HDL-C]).
RESULTS


The body weight of the participants in the NW was lower at week 12 by an average of 5 kg, BMI by 6%, FB by 19%, FM by 15%, WC by 8%, HC by 6%, and WHR by 3%. In the MD, the respective decreases were 8 kg and 8, 25, 20, 6, 2, and 7%. In the MD, the postintervention concentrations of TC and TG were within the reference range.
CONCLUSION


Both 12-week interventions improved the anthropometric parameters and blood lipid profiles of retired heavy manual workers, with the improvements being more pronounced in the dieting group.",2020,"Both 12-week interventions improved the anthropometric parameters and blood lipid profiles of retired heavy manual workers, with the improvements being more pronounced in the dieting group.","['body weight 96.6 ± 13.9 kg', 'Overweight and Obese Ex-Coal Miners', 'overweight and obese retired miners with lipid disorders', 'The study participants (n = 30, aged 58.7 ± 4.1 years, body height 174.8 ± 7.3 cm']","['Nordic walking group (NW', 'regular physical activity or a modified lower-calorie diet', 'Nordic Walking Exercise and a Modified Diet']","['body weight', 'anthropometric parameters (body weight, fat mass content [FM], fat percentage [BF], BMI, waist circumference [WC], hip circumference [HC], and waist-to-hip ratio [WHR]) and blood lipid indicators (total cholesterol [TC], triglycerides [TG], low density lipoprotein cholesterol [LDL-C], and high density lip-oprotein cholesterol [HDL-C', 'anthropometric parameters and blood lipid profiles', 'postintervention concentrations of TC and TG']","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C4517562', 'cui_str': '13.9 (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0341671', 'cui_str': 'Coal miner (occupation)'}, {'cui': 'C0035345', 'cui_str': 'Retirement'}, {'cui': 'C0240346', 'cui_str': 'Mineworkers'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005890', 'cui_str': 'Body Height'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2930544', 'cui_str': 'Low-Calorie Diet'}, {'cui': 'C0452264', 'cui_str': 'Therapeutic diets (finding)'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1264657', 'cui_str': 'Mass content'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference (observable entity)'}, {'cui': 'C0205682', 'cui_str': 'Waist-Hip Ratio'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0333972', 'cui_str': 'Lipping (morphologic abnormality)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.014178,"Both 12-week interventions improved the anthropometric parameters and blood lipid profiles of retired heavy manual workers, with the improvements being more pronounced in the dieting group.","[{'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Sadowska-Krępa', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland, e.sadowska-krepa@awf.katowice.pl.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Gdańska', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Rozpara', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Pilch', 'Affiliation': 'Department of Biochemistry and Basic of Cosmetology, University School of Physical Education, Krakow, Poland.'}, {'ForeName': 'Miroslava', 'Initials': 'M', 'LastName': 'Přidalová', 'Affiliation': 'Department of Natural Sciences in Kinanthropology, Faculty of Physical Culture, Palacký University, Olomouc, Czechia.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Bańkowski', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland.'}]",Obesity facts,['10.1159/000506403']
730,32205547,Individualized Fluid Management Using the Pleth Variability Index: A Randomized Clinical Trial.,"BACKGROUND


The present trial was designed to assess whether individualized strategies of fluid administration using a noninvasive plethysmographic variability index could reduce the postoperative hospital length of stay and morbidity after intermediate-risk surgery.
METHODS


This was a multicenter, randomized, nonblinded parallel-group clinical trial conducted in five hospitals. Adult patients in sinus rhythm having elective orthopedic surgery (knee or hip arthroplasty) under general anesthesia were enrolled. Individualized hemodynamic management aimed to achieve a plethysmographic variability index under 13%, and the standard management strategy aimed to maintain a mean arterial pressure above 65 mmHg during general anesthesia. The primary outcome was the postoperative hospital length of stay decided by surgeons blinded to the group allocation of the patient.
RESULTS


In total, 447 patients were randomized, and 438 were included in the analysis. The mean hospital length of stay ± SD was 6 ± 3 days for the plethysmographic variability index group and 6 ± 3 days for the control group (adjusted difference, 0.0 days; 95% CI, -0.6 to 0.5; P = 0.860); the theoretical postoperative hospital length of stay was 4 ± 2 days for the plethysmographic variability index group and 4 ± 1 days for the control group (P = 0.238). In the plethysmographic variability index and control groups, serious postoperative cardiac complications occurred in 3 of 217 (1%) and 2 of 224 (1%) patients (P = 0.681), acute postoperative renal failure occurred in 9 (4%) and 8 (4%) patients (P = 0.808), the troponin Ic concentration was more than 0.06 μg/l within 5 days postoperatively for 6 (3%) and 5 (2%) patients (P = 0.768), and the postoperative arterial lactate measurements were 1.44 ± 1.01 and 1.43 ± 0.95 mmol/l (P = 0.974), respectively.
CONCLUSIONS


Among intermediate-risk patients having orthopedic surgery with general anesthesia, fluid administration guided by the plethysmographic variability index did not shorten the duration of hospitalization or reduce complications.",2020,Plethysmographic-guided fluid management did not reduce the duration of hospitalization or complications in moderate-risk surgery patients.,"['Adult patients in sinus rhythm having elective orthopedic surgery (knee or hip arthroplasty) under general anesthesia were enrolled', '447 moderate-risk major arthroplasty patients to', 'intermediate-risk patients having orthopedic surgery with general anesthesia', '447 patients were randomized, and 438 were included in the analysis', 'moderate-risk surgery patients', 'five hospitals']","['Plethysmographic-guided fluid management', 'plethysmographic-guided versus routine fluid management', 'Individualized Fluid Management']","['theoretical postoperative hospital length of stay', 'postoperative arterial lactate measurements', 'duration of hospitalization or reduce complications', 'serious postoperative cardiac complications', 'postoperative hospital length of stay and morbidity', 'acute postoperative renal failure', 'duration of hospitalization or complications', 'mean hospital length of stay ± SD', 'postoperative hospital length of stay decided by surgeons blinded to the group allocation of the patient', 'Fitness for discharge and actual hospital durations', 'troponin Ic concentration', 'noninvasive plethysmographic variability index']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0232201', 'cui_str': 'Coronary sinus rhythm'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0162439', 'cui_str': 'Orthopedic Surgery'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0553741', 'cui_str': 'Hydration control'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0340276', 'cui_str': 'Postoperative cardiac complication (disorder)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C2585625', 'cui_str': 'Acute postoperative renal failure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0523952', 'cui_str': 'Troponin measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",447.0,0.161995,Plethysmographic-guided fluid management did not reduce the duration of hospitalization or complications in moderate-risk surgery patients.,"[{'ForeName': 'Marc-Olivier', 'Initials': 'MO', 'LastName': 'Fischer', 'Affiliation': 'From the Anesthesiology and Critical Care Medicine Department (M.-O.F., S.L., W.G., G.D., J.-L.H.) the INSERM COMETE 1075 Unit, Orthopedic Department, (C.H.) the Biostatistics Department (J.-J.P.), Normandy University, Caen University Hospital, Caen, France Anesthesiology and Critical Care Medicine Department, Lille University Hospital, Lille, France (B.T., M.H.) Anesthesiology and Intensive Care Medicine Department, Hospital of Catholic Institute of Lille, Saint Philibert Hospital, Lomme, France (C.-E.B., V.C.) Anesthesiology and Critical Care Medicine Department, Rouen University Hospital, Charles Nicolle Hospital, Rouen, France (V.C.) Anesthesiology and Critical Care Department, Amiens University Hospital, Amiens, France (D.T., E.L.) Research Unit on Simplified Care of Complex Surgical Patients, Jules Verne University of Picardy, Amiens, France (E.L.). Caen University Hospital, Caen, France Caen University Hospital, Caen, France Amiens Picardie University Hospital, Amiens, France Amiens Picardie University Hospital, Amiens, France Lille University Hospital, Lille, France Lille University Hospital, Lille, France Hospital of Catholic Institute of Lille, Lomme, France Clinical Research Department, Caen University Hospital Clinical Research Department, Caen University Hospital Clinical Research Department, Caen University Hospital Clinical Research Department, Hospital of Catholic Institute of Lille Clinical Research Department, Lille University Hospital Clinical Research Department, Lille University Hospital Clinical Research Department, Amiens Picardie University Hospital.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Lemoine', 'Affiliation': ''}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Tavernier', 'Affiliation': ''}, {'ForeName': 'Chems-Eddine', 'Initials': 'CE', 'LastName': 'Bouchakour', 'Affiliation': ''}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Colas', 'Affiliation': ''}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Houard', 'Affiliation': ''}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Greub', 'Affiliation': ''}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Daccache', 'Affiliation': ''}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Hulet', 'Affiliation': ''}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Compère', 'Affiliation': ''}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Taing', 'Affiliation': ''}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Lorne', 'Affiliation': ''}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Parienti', 'Affiliation': ''}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Hanouz', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003260']
731,32401339,Program of Active Consumer Engagement in Self-Management in Epilepsy: Replication and extension of a self-management randomized controlled trial.,"OBJECTIVE


The Program of Active Consumer Engagement in Self-Management in Epilepsy (PACES) is an evidenced-based self-management intervention for adults with epilepsy. Prior randomized controlled trial (RCT) data show that PACES reduces depression and improves self-management, self-efficacy, and quality of life for 6 months postprogram. The objective of this study was to replicate a PACES RCT with key extensions: more diverse patient pool from community-based epilepsy centers; option for telephone-based participation; and longer follow-up (12 months with booster support for intervention group), to examine duration of impact and inform dissemination and implementation.
METHODS


Participants were adults with chronic epilepsy (n = 101) without serious mental illness or substantive intellectual impairment, recruited from three epilepsy centers. Participants were randomly assigned to intervention or waitlist control groups. Outcomes included the Epilepsy Self-Management Scale (ESMS), Epilepsy Self-Efficacy Scale (ESES), Quality of Life in Epilepsy-31, Patient Health Questionnaire-9, and Generalized Anxiety Disorder-7, administered at baseline, postintervention (8 weeks), and 6 and 12 months postintervention. Intervention was an 8-week group of five to eight adults co-led by a psychologist and trained peer with epilepsy that met once per week by teleconference or in person at a hospital for 60-75 minutes. Topics included medical, psychosocial, cognitive, and self-management aspects of epilepsy, as well as community integration and epilepsy-related communication. Treatment group provided program evaluation.
RESULTS


PACES participants (n = 49) improved relative to controls (n = 52) on the ESES (P < .022) and overall distress composite (P = .008). At 6 months, PACES participants remained improved on the ESES (P = .008) and composite (P = .001), and were improved on the ESMS (P = .005). At 12 months, PACES participants remained improved on the ESMS (P = .006) and were improved on an overall distress composite of combined measures (P = .018). Attrition was low (<6% in each group), and all program satisfaction ratings exceeded 4.0/5.0.
SIGNIFICANCE


A consumer-generated epilepsy self-management program with broad psychosocial and medical emphasis can be effectively delivered by telephone or in person and facilitates long-term epilepsy self-management, adjustment, and coping up to 1 year after treatment.",2020,"At 12 months, PACES participants remained improved on the ESMS (P = .006) and were improved on an overall distress composite of combined measures (P = .018).","['Participants were adults with chronic epilepsy (n\xa0=\xa0101) without serious mental illness or substantive intellectual impairment, recruited from three epilepsy centers', 'Epilepsy', 'adults with epilepsy']","['PACES', 'adults co-led by a psychologist and trained peer with epilepsy that met once per week by teleconference or in person at a hospital for 60-75\xa0minutes']","['depression and improves self-management, self-efficacy, and quality of life', 'ESMS', 'overall distress composite of combined measures', 'Attrition', 'Epilepsy Self-Management Scale (ESMS), Epilepsy Self-Efficacy Scale (ESES), Quality of Life in Epilepsy-31, Patient Health Questionnaire-9, and Generalized Anxiety Disorder-7', 'overall distress composite', 'ESES']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0039450', 'cui_str': 'Teleconference'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}]",101.0,0.0591539,"At 12 months, PACES participants remained improved on the ESMS (P = .006) and were improved on an overall distress composite of combined measures (P = .018).","[{'ForeName': 'Erica K', 'Initials': 'EK', 'LastName': 'Johnson', 'Affiliation': 'Health Promotion Research Center, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Fraser', 'Affiliation': 'Health Promotion Research Center, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Lashley', 'Affiliation': 'Department of Neurology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Barber', 'Affiliation': 'Department of Neurological Surgery, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Erica M', 'Initials': 'EM', 'LastName': 'Brandling-Bennett', 'Affiliation': 'UW Medicine, Valley Medical Center, Renton, Washington, USA.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Vossler', 'Affiliation': 'Department of Neurology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Miller', 'Affiliation': 'Department of Neurology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Caylor', 'Affiliation': 'Swedish Neuroscience Institute, Seattle, Washington, USA.'}, {'ForeName': 'Tessala', 'Initials': 'T', 'LastName': 'Warheit-Niemi', 'Affiliation': 'Neurology Vocational Services Unit, University of Washington, Seattle, Washington, USA.'}]",Epilepsia,['10.1111/epi.16530']
732,32176061,"Apatinib combined with chemotherapy or concurrent chemo-brachytherapy in patients with recurrent or advanced cervical cancer: A phase 2, randomized controlled, prospective study.","OBJECTIVE


Apatinib mesylate is a novel vascular endothelial growth factor receptor 2 (VEGFR-2) inhibitor, which has exhibited good safety and efficacy in several types of solid tumors. The present study aimed to assess the clinical efficacy and safety of apatinib combined with chemotherapy and concurrent chemo-brachytherapy (CCBT) in patients with recurrent and advanced cervical cancer.
METHODS


A total of 52 patients with first diagnosed recurrent or untreated International Federation of Gynecology and Obstetrics stage IVB cervical cancer admitted at Shandong Cancer Hospital and Institute between July 2016 and May 2018 were analyzed in the current randomized controlled trial. The patients were randomly divided into 2 groups: the apatinib-treated group and the control group. Patients with recurrent cervical cancer in the apatinib-treated group were administered apatinib and carboplatin-paclitaxel as first-line chemotherapy. Patients with advanced cervical cancer were administered apatinib in combination with CCBT. In control group, patients with recurrent cervical cancer were treated with chemotherapy alone while patients with advanced cervical cancer received CCBT.
RESULTS


The progression-free survival was significantly prolonged in apatinib group compared with control group (10.1 months; 95% confidence interval (CI), 8.42-11.79 vs 6.4 months; 95% CI, 3.88-8.92; P < .01; hazard ratio (HR), 0.44; 95% CI, 0.25-0.78; P < .01). The objective response rate in apatinib group was obviously higher than that in control group (64.3% vs 33.3%, P < .05). Proteinuria, hand-foot syndrome, mucositis, and hypertension in all Grades were statistically more common in apatinib group than in control group. Apatinib did not obviously aggravate other radiotherapy or chemotherapy side effects.
CONCLUSION


Apatinib exhibited promising clinical efficacy in cervical cancer patients, resulting in an improved response rate and prolonged progression-free survival compared with the control group, and had manageable side effects. Our study revealed that apatinib combination therapy, adenocarcinoma, and bone metastasis.",2020,"Proteinuria, hand-foot syndrome, mucositis, and hypertension in all Grades were statistically more common in apatinib group than in control group.","['Patients with advanced cervical cancer', 'cervical cancer patients', 'patients with recurrent or advanced cervical cancer', 'Patients with recurrent cervical cancer', 'patients with recurrent and advanced cervical cancer', '52 patients with first diagnosed recurrent or untreated International Federation of Gynecology and Obstetrics stage IVB cervical cancer admitted at Shandong Cancer Hospital and Institute between July 2016 and May 2018', 'patients with recurrent cervical cancer']","['apatinib and carboplatin-paclitaxel as first-line chemotherapy', 'chemotherapy alone', 'CCBT', 'radiotherapy', 'apatinib combined with chemotherapy and concurrent chemo-brachytherapy (CCBT', 'Apatinib combined with chemotherapy or concurrent chemo-brachytherapy']","['clinical efficacy and safety', 'progression-free survival', 'Proteinuria, hand-foot syndrome, mucositis, and hypertension', 'objective response rate', 'response rate and prolonged progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0450454', 'cui_str': 'FIGO Stage'}, {'cui': 'C0019999', 'cui_str': 'Hospitals, Cancer'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}]","[{'cui': 'C2346836', 'cui_str': '3-Pyridinecarboxamide, N-(4-(1-cyanocyclopentyl)phenyl)-2-((4-methyl-3-pyridinyl)amino)-'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0006098', 'cui_str': 'Radioisotope Brachytherapy'}]","[{'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0852711', 'cui_str': 'Hand-foot syndrome in sickle cell anemia (disorder)'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}]",52.0,0.0580297,"Proteinuria, hand-foot syndrome, mucositis, and hypertension in all Grades were statistically more common in apatinib group than in control group.","[{'ForeName': 'Qiufen', 'Initials': 'Q', 'LastName': 'Guo', 'Affiliation': 'Department of Obstetrics and Gynecology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan.'}, {'ForeName': 'Yawen', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Education and Cancer Prevention, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, Shandong, PR China.'}, {'ForeName': 'Enqi', 'Initials': 'E', 'LastName': 'Kong', 'Affiliation': 'Department of Gynecological Oncology.'}, {'ForeName': 'Linli', 'Initials': 'L', 'LastName': 'Rao', 'Affiliation': 'Department of Gynecological Oncology.'}, {'ForeName': 'Jinlong', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Gynecological Oncology.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Department of Gynecological Oncology.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of Gynecological Oncology.'}, {'ForeName': 'Naifu', 'Initials': 'N', 'LastName': 'Liu', 'Affiliation': 'Department of Gynecological Oncology.'}, {'ForeName': 'Mingjiang', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynecology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Department of Gynecological Oncology, Qingdao Central Hospital, The Second Affiliated Hospital of Qingdao University, Qingdao.'}]",Medicine,['10.1097/MD.0000000000019372']
733,31977517,Saline versus Lactated Ringer's Solution: The Saline or Lactated Ringer's (SOLAR) Trial.,"BACKGROUND


Both saline and lactated Ringer's solutions are commonly given to surgical patients. However, hyperchloremic acidosis consequent to saline administration may provoke complications. The authors therefore tested the primary hypothesis that a composite of in-hospital mortality and major postoperative complications is less common in patients given lactated Ringer's solution than normal saline.
METHODS


The authors conducted an alternating cohort controlled trial in which adults having colorectal and orthopedic surgery were given either lactated Ringer's solution or normal saline in 2-week blocks between September 2015 and August 2018. The primary outcome was a composite of in-hospital mortality and major postoperative renal, respiratory, infectious, and hemorrhagic complications. The secondary outcome was postoperative acute kidney injury.
RESULTS


Among 8,616 qualifying patients, 4,187 (49%) were assigned to lactated Ringer's solution, and 4,429 (51%) were assigned to saline. Each group received a median 1.9 l of fluid. The primary composite of major complications was observed in 5.8% of lactated Ringer's versus 6.1% of normal saline patients, with estimated average relative risk across the components of the composite of 1.16 (95% CI, 0.89 to 1.52; P = 0.261). The secondary outcome, postoperative acute kidney injury, Acute Kidney Injury Network stage I-III versus 0, occurred in 6.6% of lactated Ringer's patients versus 6.2% of normal saline patients, with an estimated relative risk of 1.18 (99.3% CI, 0.99 to 1.41; P = 0.009, significance criterion of 0.007). Absolute differences between the treatment groups for each outcome were less than 0.5%, an amount that is not clinically meaningful.
CONCLUSIONS


In elective orthopedic and colorectal surgery patients, there was no clinically meaningful difference in postoperative complications with lactated Ringer's or saline volume replacement. Clinicians can reasonably use either solution intraoperatively.",2020,"In elective orthopedic and colorectal surgery patients, there was no clinically meaningful difference in postoperative complications with lactated Ringer's or saline volume replacement.","['adults having colorectal and orthopedic surgery', '8,616 qualifying patients, 4,187 (49', 'elective orthopedic and colorectal surgery patients']","[""lactated Ringer's solution"", ""lactated Ringer's solution or normal saline"", ""Saline versus Lactated Ringer's Solution"", ""Saline or Lactated Ringer's"", ""saline and lactated Ringer's solutions""]","['postoperative complications', 'composite of in-hospital mortality and major postoperative renal, respiratory, infectious, and hemorrhagic complications', 'postoperative acute kidney injury', 'postoperative acute kidney injury, Acute Kidney Injury Network stage I-III versus 0', 'major complications']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0162439', 'cui_str': 'Orthopedic Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0009369', 'cui_str': 'Colon and Rectal Surgery Specialty'}]","[{'cui': 'C0073385', 'cui_str': ""Hartmann's Solution""}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]",8616.0,0.722242,"In elective orthopedic and colorectal surgery patients, there was no clinically meaningful difference in postoperative complications with lactated Ringer's or saline volume replacement.","[{'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Maheshwari', 'Affiliation': ""From the Department of General Anesthesiology (K.M., A.T., W.A.S.E., K.R., S.B., A.G.K., M.R.R., T.K., G.R.B., A.K.) Department of Outcomes Research (K.M., A.T., N.M., C.M., K.R., H.E., B.C., I.S., G.R.B., D.C., E.J.M., A.K., D.I.S.) Department of Quantitative Health Sciences (N.M., C.M., E.J.M.) Department of Orthopedic Surgery (C.H.-R.), Cleveland Clinic, Cleveland, Ohio the Division of Colon and Rectal Surgery, Mayo Clinic, Jacksonville, Florida (L.S.) the Division of Anesthesia, Critical Care, and Pain Management, Tel-Aviv Medical Center, Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel (B.C.) the Department of Anesthesia, St. Elizabeth's Medical Center, Boston, Massachusetts (I.S.).""}, {'ForeName': 'Alparslan', 'Initials': 'A', 'LastName': 'Turan', 'Affiliation': ''}, {'ForeName': 'Natalya', 'Initials': 'N', 'LastName': 'Makarova', 'Affiliation': ''}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': ''}, {'ForeName': 'Wael Ali Sakr', 'Initials': 'WAS', 'LastName': 'Esa', 'Affiliation': ''}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Ruetzler', 'Affiliation': ''}, {'ForeName': 'Sabri', 'Initials': 'S', 'LastName': 'Barsoum', 'Affiliation': ''}, {'ForeName': 'Alan G', 'Initials': 'AG', 'LastName': 'Kuhel', 'Affiliation': ''}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Ritchey', 'Affiliation': ''}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Higuera-Rueda', 'Affiliation': ''}, {'ForeName': 'Tatyana', 'Initials': 'T', 'LastName': 'Kopyeva', 'Affiliation': ''}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Stocchi', 'Affiliation': ''}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Essber', 'Affiliation': ''}, {'ForeName': 'Barak', 'Initials': 'B', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'Suleiman', 'Affiliation': ''}, {'ForeName': 'Gausan R', 'Initials': 'GR', 'LastName': 'Bajracharya', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chelnick', 'Affiliation': ''}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Mascha', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Kurz', 'Affiliation': ''}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003130']
734,31216226,Final Overall Survival of a Randomized Trial of Bevacizumab for Primary Treatment of Ovarian Cancer.,"PURPOSE


We report the final, protocol-specified analysis of overall survival (OS) in GOG-0218, a phase III, randomized trial of bevacizumab in women with newly diagnosed ovarian, fallopian tube, or primary peritoneal carcinoma.
METHODS


A total of 1,873 women with incompletely resected stage III to IV disease were randomly assigned 1:1:1 to six 21-day cycles of intravenous carboplatin (area under the concentration  v  time curve 6) and paclitaxel (175 mg/m 2 ) versus chemotherapy plus concurrent bevacizumab (15 mg/kg, cycles 2 to 6) versus chemotherapy plus concurrent and maintenance bevacizumab (cycles 2 to 22). Inclusion criteria included a Gynecologic Oncology Group performance status of 0 to 2 and no history of clinically significant vascular events or evidence of intestinal obstruction. OS was analyzed in the intention-to-treat population. A total of 1,195 serum and/or tumor specimens were sequenced for  BRCA1/2  and damaging mutations in homologous recombination repair (HRR) genes. Intratumoral microvessel density was studied using CD31 immunohistochemistry.
RESULTS


Median follow-up was 102.9 months. Relative to control (n = 625), for patients receiving bevacizumab-concurrent (n = 625), the hazard ratio (HR) of death was 1.06 (95% CI, 0.94 to 1.20); for bevacizumab-concurrent plus maintenance (n = 623), the HR was 0.96 (95% CI, 0.85 to 1.09). Disease-specific survival was not improved in any arm. No survival advantage was observed after censoring patients who received bevacizumab at crossover or as second line. Median OS for stage IV bevacizumab-concurrent plus maintenance was 42.8  v  32.6 months for stage IV control (HR, 0.75; 95% CI, 0.59 to 0.95). Relative to wild type, the HR for death for  BRCA1/2  mutated carcinomas was 0.62 (95% CI, 0.52 to 0.73), and for non- BRCA1/2  HRR, the HR was 0.65 (95% CI, 0.51 to 0.85).  BRCA1/2 , HRR, and CD31 were not predictive of bevacizumab activity.
CONCLUSION


No survival differences were observed for patients who received bevacizumab compared with chemotherapy alone. Testing for  BRCA1/2  mutations and homologous recombination deficiency is essential.",2019,Disease-specific survival was not improved in any arm.,"['women with newly diagnosed ovarian, fallopian tube, or primary peritoneal carcinoma', '1,873 women with incompletely resected stage III to IV disease', 'Ovarian Cancer']","['intravenous carboplatin (area under the concentration  v  time curve 6) and paclitaxel', 'bevacizumab', 'Bevacizumab', 'chemotherapy plus concurrent and maintenance bevacizumab', 'bevacizumab-concurrent', 'chemotherapy plus concurrent bevacizumab']","['hazard ratio (HR) of death', 'survival differences', 'Disease-specific survival', 'survival advantage', 'Median OS', 'Intratumoral microvessel density', 'BRCA1/2 , HRR, and CD31', 'vascular events or evidence of intestinal obstruction']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0015560', 'cui_str': 'Oviducts, Mammalian'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0948303', 'cui_str': 'Peritoneal carcinoma'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2350570', 'cui_str': 'Microvessels'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0021843', 'cui_str': 'Intestinal Obstruction'}]",1873.0,0.353929,Disease-specific survival was not improved in any arm.,"[{'ForeName': 'Krishnansu S', 'Initials': 'KS', 'LastName': 'Tewari', 'Affiliation': 'University of California, Irvine, Medical Center, Orange, CA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Burger', 'Affiliation': 'University of Pennsylvania Abramson Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Enserro', 'Affiliation': 'Roswell Park Cancer Institute, Buffalo, NY.'}, {'ForeName': 'Barbara M', 'Initials': 'BM', 'LastName': 'Norquist', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Swisher', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'Mark F', 'Initials': 'MF', 'LastName': 'Brady', 'Affiliation': 'Roswell Park Cancer Institute, Buffalo, NY.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Bookman', 'Affiliation': 'Permanente Medical Group, San Francisco, CA.'}, {'ForeName': 'Gini F', 'Initials': 'GF', 'LastName': 'Fleming', 'Affiliation': 'The University of Chicago, Chicago, IL.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Roswell Park Cancer Institute, Buffalo, NY.'}, {'ForeName': 'Howard D', 'Initials': 'HD', 'LastName': 'Homesley', 'Affiliation': 'Indiana University Medical Center, Indianapolis, IN.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Fowler', 'Affiliation': 'The Ohio State University James Cancer Hospital, Columbus, OH.'}, {'ForeName': 'Benjamin E', 'Initials': 'BE', 'LastName': 'Greer', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Boente', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Sharon X', 'Initials': 'SX', 'LastName': 'Liang', 'Affiliation': 'Western Pennsylvania Hospital, Pittsburgh, PA.'}, {'ForeName': 'Chenglin', 'Initials': 'C', 'LastName': 'Ye', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Bais', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Leslie M', 'Initials': 'LM', 'LastName': 'Randall', 'Affiliation': 'University of California, Irvine, Medical Center, Orange, CA.'}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'Chan', 'Affiliation': 'California Pacific Medical Center Research Institute, San Francisco, CA.'}, {'ForeName': 'J Stuart', 'Initials': 'JS', 'LastName': 'Ferriss', 'Affiliation': 'Dell Seton Medical Center at The University of Texas, Austin, TX.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Aghajanian', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Herzog', 'Affiliation': 'University of Cincinnati Cancer Institute, Cincinnati, OH.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'DiSaia', 'Affiliation': 'University of California, Irvine, Medical Center, Orange, CA.'}, {'ForeName': 'Larry J', 'Initials': 'LJ', 'LastName': 'Copeland', 'Affiliation': 'The Ohio State University James Cancer Hospital, Columbus, OH.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Mannel', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, OK.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Birrer', 'Affiliation': 'University of Alabama, Birmingham, AL.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Monk', 'Affiliation': 'University of Arizona and Creighton University, Phoenix, AZ.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01009']
735,32115853,A metabolomics-based molecular pathway analysis of how the sodium-glucose co-transporter-2 inhibitor dapagliflozin may slow kidney function decline in patients with diabetes.,"AIM


To investigate which metabolic pathways are targeted by the sodium-glucose co-transporter-2 inhibitor dapagliflozin to explore the molecular processes involved in its renal protective effects.
METHODS


An unbiased mass spectrometry plasma metabolomics assay was performed on baseline and follow-up (week 12) samples from the EFFECT II trial in patients with type 2 diabetes with non-alcoholic fatty liver disease receiving dapagliflozin 10 mg/day (n = 19) or placebo (n = 6). Transcriptomic signatures from tubular compartments were identified from kidney biopsies collected from patients with diabetic kidney disease (DKD) (n = 17) and healthy controls (n = 30) from the European Renal cDNA Biobank. Serum metabolites that significantly changed after 12 weeks of dapagliflozin were mapped to a metabolite-protein interaction network. These proteins were then linked with intra-renal transcripts that were associated with DKD or estimated glomerular filtration rate (eGFR). The impacted metabolites and their protein-coding transcripts were analysed for enriched pathways.
RESULTS


Of all measured (n = 812) metabolites, 108 changed (P < 0.05) during dapagliflozin treatment and 74 could be linked to 367 unique proteins/genes. Intra-renal mRNA expression analysis of the genes encoding the metabolite-associated proteins using kidney biopsies resulted in 105 genes that were significantly associated with eGFR in patients with DKD, and 135 genes that were differentially expressed between patients with DKD and controls. The combination of metabolites and transcripts identified four enriched pathways that were affected by dapagliflozin and associated with eGFR: glycine degradation (mitochondrial function), TCA cycle II (energy metabolism), L-carnitine biosynthesis (energy metabolism) and superpathway of citrulline metabolism (nitric oxide synthase and endothelial function).
CONCLUSION


The observed molecular pathways targeted by dapagliflozin and associated with DKD suggest that modifying molecular processes related to energy metabolism, mitochondrial function and endothelial function may contribute to its renal protective effect.",2020,108 changed (p<0.05) during dapagliflozin treatment and 74 could be linked to 367 unique proteins/genes.,"['patients with diabetes', 'diabetic kidney disease (DKD', 'n=6) Transcriptomic signatures from tubular compartments were identified from kidney biopsies collected from patients with DKD (n=17) and healthy controls (n=30) from the European Renal cDNA Biobank (ERCB', 'type 2 diabetes patients with non-alcoholic fatty liver disease receiving']","['placebo', 'dapagliflozin']",['Serum metabolites'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0011881', 'cui_str': 'Diabetic Nephropathy'}, {'cui': 'C0332208', 'cui_str': 'Tubular (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0194073', 'cui_str': 'Kidney biopsy (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0006556', 'cui_str': 'cDNA'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",,0.0506005,108 changed (p<0.05) during dapagliflozin treatment and 74 could be linked to 367 unique proteins/genes.,"[{'ForeName': 'Skander', 'Initials': 'S', 'LastName': 'Mulder', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Hammarstedt', 'Affiliation': 'AstraZeneca, BioPharmaceuticals R&D, Mölndal, Sweden.'}, {'ForeName': 'Sunil B', 'Initials': 'SB', 'LastName': 'Nagaraj', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Viji', 'Initials': 'V', 'LastName': 'Nair', 'Affiliation': 'Michigan University, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Ju', 'Affiliation': 'Michigan University, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Jonatan', 'Initials': 'J', 'LastName': 'Hedberg', 'Affiliation': 'AstraZeneca, BioPharmaceuticals R&D, Mölndal, Sweden.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Greasley', 'Affiliation': 'AstraZeneca, BioPharmaceuticals R&D, Mölndal, Sweden.'}, {'ForeName': 'Jan W', 'Initials': 'JW', 'LastName': 'Eriksson', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Oscarsson', 'Affiliation': 'AstraZeneca, BioPharmaceuticals R&D, Mölndal, Sweden.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14018']
736,31910279,Effect of Folic Acid and Zinc Supplementation in Men on Semen Quality and Live Birth Among Couples Undergoing Infertility Treatment: A Randomized Clinical Trial.,"Importance


Dietary supplements marketed for male fertility commonly contain folic acid and zinc based on limited prior evidence for improving semen quality. However, no large-scale trial has examined the efficacy of this therapy for improving semen quality or live birth.
Objective


To determine the effect of daily folic acid and zinc supplementation on semen quality and live birth.
Design, Setting, and Participants


The Folic Acid and Zinc Supplementation Trial was a multicenter randomized clinical trial. Couples (n = 2370; men aged ≥18 years and women aged 18-45 years) planning infertility treatment were enrolled at 4 US reproductive endocrinology and infertility care study centers between June 2013 and December 2017. The last 6-month study visit for semen collection occurred during August 2018, with chart abstraction of live birth and pregnancy information completed during April 2019.
Interventions


Men were block randomized by study center and planned infertility treatment (in vitro fertilization, other treatment at a study site, and other treatment at an outside clinic) to receive either 5 mg of folic acid and 30 mg of elemental zinc (n = 1185) or placebo (n = 1185) daily for 6 months.
Main Outcomes and Measures


The co-primary outcomes were live birth (resulting from pregnancies occurring within 9 months of randomization) and semen quality parameters (sperm concentration, motility, morphology, volume, DNA fragmentation, and total motile sperm count) at 6 months after randomization.
Results


Among 2370 men who were randomized (mean age, 33 years), 1773 (75%) attended the final 6-month study visit. Live birth outcomes were available for all couples, and 1629 men (69%) had semen available for analysis at 6 months after randomization. Live birth was not significantly different between treatment groups (404 [34%] in the folic acid and zinc group and 416 [35%] in the placebo group; risk difference, -0.9% [95% CI, -4.7% to 2.8%]). Most of the semen quality parameters (sperm concentration, motility, morphology, volume, and total motile sperm count) were not significantly different between treatment groups at 6 months after randomization. A statistically significant increase in DNA fragmentation was observed with folic acid and zinc supplementation (mean of 29.7% for percentage of DNA fragmentation in the folic acid and zinc group and 27.2% in the placebo group; mean difference, 2.4% [95% CI, 0.5% to 4.4%]). Gastrointestinal symptoms were more common with folic acid and zinc supplementation compared with placebo (abdominal discomfort or pain: 66 [6%] vs 40 [3%], respectively; nausea: 50 [4%] vs 24 [2%]; and vomiting: 32 [3%] vs 17 [1%]).
Conclusions and Relevance


Among a general population of couples seeking infertility treatment, the use of folic acid and zinc supplementation by male partners, compared with placebo, did not significantly improve semen quality or couples' live birth rates. These findings do not support the use of folic acid and zinc supplementation by male partners in the treatment of infertility.
Trial Registration


ClinicalTrials.gov Identifier: NCT01857310.",2020,"Live birth was not significantly different between treatment groups (404 [34%] in the folic acid and zinc group and 416 [35%] in the placebo group; risk difference, -0.9% [95% CI, -4.7% to 2.8%]).","['Couples (n\u2009', 'Couples Undergoing Infertility Treatment', '2370 men who were randomized (mean age, 33 years), 1773 (75%) attended the final 6-month study visit', '2370; men aged ≥18 years and women aged 18-45 years) planning infertility treatment were enrolled at 4 US reproductive endocrinology and infertility care study centers between June 2013 and December 2017']","['planned infertility treatment (in vitro fertilization', 'placebo', 'folic acid and zinc', 'daily folic acid and zinc supplementation', 'folic acid and zinc supplementation', 'folic acid and 30 mg of elemental zinc (n\u2009=\u20091185) or placebo', 'Folic Acid and Zinc Supplementation']","['Live birth', 'Live birth outcomes', 'vomiting', 'semen quality and live birth', 'DNA fragmentation', 'nausea', 'Gastrointestinal symptoms', 'live birth (resulting from pregnancies occurring within 9 months of randomization) and semen quality parameters (sperm concentration, motility, morphology, volume, DNA fragmentation, and total motile sperm count', 'Semen Quality and Live Birth', 'semen quality or live birth', 'semen quality parameters (sperm concentration, motility, morphology, volume, and total motile sperm count', ""semen quality or couples' live birth rates""]","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0200070', 'cui_str': 'Infertility therapy (procedure)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0014137', 'cui_str': 'Endocrinology'}, {'cui': 'C1171199', 'cui_str': 'Family planning: infertility'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0200070', 'cui_str': 'Infertility therapy (procedure)'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}]","[{'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C2717747', 'cui_str': 'Semen Quality'}, {'cui': 'C0376669', 'cui_str': 'DNA Fragmentation'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1261167', 'cui_str': 'Sperm concentration'}, {'cui': 'C1510470', 'cui_str': 'Motility (observable entity)'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4301985', 'cui_str': 'Motile spermatozoa'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]",2370.0,0.613709,"Live birth was not significantly different between treatment groups (404 [34%] in the folic acid and zinc group and 416 [35%] in the placebo group; risk difference, -0.9% [95% CI, -4.7% to 2.8%]).","[{'ForeName': 'Enrique F', 'Initials': 'EF', 'LastName': 'Schisterman', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Lindsey A', 'Initials': 'LA', 'LastName': 'Sjaarda', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Traci', 'Initials': 'T', 'LastName': 'Clemons', 'Affiliation': 'Emmes Company LLC, Rockville, Maryland.'}, {'ForeName': 'Douglas T', 'Initials': 'DT', 'LastName': 'Carrell', 'Affiliation': 'Departments of Surgery (Urology) and Human Genetics, School of Medicine, University of Utah, Salt Lake City.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Perkins', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Johnstone', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Utah, Salt Lake City.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Lamb', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Utah, Salt Lake City.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'Chaney', 'Affiliation': 'Emmes Company LLC, Rockville, Maryland.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Van Voorhis', 'Affiliation': 'Department of Obstetrics and Gynecology, Carver College of Medicine, University of Iowa, Iowa City.'}, {'ForeName': 'Ginny', 'Initials': 'G', 'LastName': 'Ryan', 'Affiliation': 'Department of Obstetrics and Gynecology, Carver College of Medicine, University of Iowa, Iowa City.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Summers', 'Affiliation': 'Department of Obstetrics and Gynecology, Carver College of Medicine, University of Iowa, Iowa City.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Hotaling', 'Affiliation': ""Center for Reconstructive Urology and Men's Health, Departments of Surgery (Urology) and Obstetrics and Gynecology, School of Medicine, University of Utah, Salt Lake City.""}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Robins', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Mills', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Mendola', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Biostatistics and Bioinformatics Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'DeVilbiss', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'C Matthew', 'Initials': 'CM', 'LastName': 'Peterson', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Utah, Salt Lake City.'}, {'ForeName': 'Sunni L', 'Initials': 'SL', 'LastName': 'Mumford', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}]",JAMA,['10.1001/jama.2019.18714']
737,31915153,Evidence Against an Important Role of Plasma Insulin and Glucagon Concentrations in the Increase in EGP Caused by SGLT2 Inhibitors.,"Sodium-glucose cotransport 2 inhibitors (SGLT2i) lower plasma glucose but stimulate endogenous glucose production (EGP). The current study examined the effect of dapagliflozin on EGP while clamping plasma glucose, insulin, and glucagon concentrations at their fasting level. Thirty-eight patients with type 2 diabetes received an 8-h measurement of EGP ([3- 3 H]-glucose) on three occasions. After a 3-h tracer equilibration, subjects received  1 ) dapagliflozin 10 mg ( n  = 26) or placebo ( n  = 12);  2 ) repeat EGP measurement with the plasma glucose concentration clamped at the fasting level; and  3 ) repeat EGP measurement with inhibition of insulin and glucagon secretion with somatostatin infusion and replacement of basal plasma insulin and glucagon concentrations. In study 1, the change in EGP (baseline to last hour of EGP measurement) in subjects receiving dapagliflozin was 22% greater (+0.66 ± 0.11 mg/kg/min,  P  < 0.05) than in subjects receiving placebo, and it was associated with a significant increase in plasma glucagon and a decrease in the plasma insulin concentration compared with placebo. Under glucose clamp conditions (study 2), the change in plasma insulin and glucagon concentrations was comparable in subjects receiving dapagliflozin and placebo, yet the difference in EGP between dapagliflozin and placebo persisted (+0.71 ± 0.13 mg/kg/min,  P  < 0.01). Under pancreatic clamp conditions (study 3), dapagliflozin produced an initial large decrease in EGP (8% below placebo), followed by a progressive increase in EGP that was 10.6% greater than placebo during the last hour. Collectively, these results indicate that  1 ) the changes in plasma insulin and glucagon concentration after SGLT2i administration are secondary to the decrease in plasma glucose concentration, and  2 ) the dapagliflozin-induced increase in EGP cannot be explained by the increase in plasma glucagon or decrease in plasma insulin or glucose concentrations.",2020,"Under glucose clamp conditions (Study 2), the change in plasma insulin and glucagon concentrations was comparable in subjects receiving dapagliflozin and placebo, yet the difference in EGP between dapagliflozin and placebo persisted (+0.71 ±0.13 mg/kg.min, p<0.01).",['38 T2DM patients'],"['dapagliflozin and placebo', 'dapagliflozin', 'placebo', '8-hour measurement of EGP', 'placebo (n=12); (ii) repeat EGP measurement with plasma glucose concentration clamped at the fasting level; (iii) repeat EGP measurement with inhibition of insulin and glucagon secretion with somatostatin infusion and replacement of basal plasma insulin and glucagon concentrations']","['plasma glucose concentration', 'EGP', 'change in EGP', 'progressive increase in EGP', 'change in plasma insulin and glucagon concentrations', 'plasma insulin and glucagon concentration', 'plasma insulin or glucose concentrations', 'EGP while clamping plasma glucose, insulin and glucagon concentrations', 'Plasma Insulin and Glucagon Concentrations', 'plasma insulin concentration', 'plasma glucagon']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1292429', 'cui_str': '8 hours (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0037659', 'cui_str': 'Somatostatin'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]","[{'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1287281', 'cui_str': 'Finding of glucose concentration, dipstick (finding)'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1278023', 'cui_str': 'Plasma glucagon measurement'}]",38.0,0.0926784,"Under glucose clamp conditions (Study 2), the change in plasma insulin and glucagon concentrations was comparable in subjects receiving dapagliflozin and placebo, yet the difference in EGP between dapagliflozin and placebo persisted (+0.71 ±0.13 mg/kg.min, p<0.01).","[{'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Alatrach', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Nitchakarn', 'Initials': 'N', 'LastName': 'Laichuthai', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, and King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Martinez', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Agyin', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Ali Muhammed', 'Initials': 'AM', 'LastName': 'Ali', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Hussein', 'Initials': 'H', 'LastName': 'Al-Jobori', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Lavynenko', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Adams', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Triplitt', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'DeFronzo', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX albarado@uthscsa.edu.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Cersosimo', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Abdul-Ghani', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}]",Diabetes,['10.2337/db19-0770']
738,32207067,Malignancy Rates in Brodalumab Clinical Studies for Psoriasis.,"BACKGROUND


Brodalumab is a fully human anti-interleukin-17 receptor A monoclonal antibody efficacious for the treatment of adults with moderate-to-severe plaque psoriasis.
OBJECTIVE


This study summarizes malignancy rates in psoriasis clinical studies of brodalumab.
METHODS


Data were pooled from one phase II study and three large, multicenter, phase III randomized studies of brodalumab for the treatment of psoriasis, including two studies with randomization to brodalumab, ustekinumab, or placebo. Data from the 52-week (brodalumab and ustekinumab) and long-term (brodalumab) pools were summarized as exposure-adjusted or follow-up time-adjusted event rates per 100 patient-years (PY).
RESULTS


Exposure-adjusted event rates per 100 PY at 52 weeks were lower with brodalumab (n = 4019; 3446 total PY of exposure) than with ustekinumab (n = 613; 495 total PY of exposure), including adjudicated malignancies (0.9 vs 2.6) and Surveillance, Epidemiology, and End Results (SEER)-adjudicated malignancies (0.3 vs 0.4). The exposure-adjusted event rate of adjudicated malignancies in the brodalumab group remained stable in the long-term analysis (0.9 [82 events]).
CONCLUSIONS


Rates of malignancy among brodalumab-treated patients with psoriasis were generally low.
TRIAL REGISTRY


ClinicalTrials.gov identifier NCT00975637; NCT01101100; NCT01708590 (AMAGINE-1); NCT01708603 (AMAGINE-2); NCT01708629 (AMAGINE-3).",2020,"RESULTS


Exposure-adjusted event rates per 100 PY at 52 weeks were lower with brodalumab (n = 4019; 3446 total PY of exposure) than with ustekinumab (n = 613; 495 total PY of exposure), including adjudicated malignancies (0.9 vs 2.6) and Surveillance, Epidemiology, and End Results (SEER)-adjudicated malignancies (0.3 vs 0.4).","['adults with moderate-to-severe plaque psoriasis', 'Data were pooled from one phase II study and three large, multicenter, phase III randomized studies of']","['brodalumab', 'brodalumab, ustekinumab, or placebo']",['Malignancy Rates'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C3491331', 'cui_str': 'brodalumab'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]",,0.0899439,"RESULTS


Exposure-adjusted event rates per 100 PY at 52 weeks were lower with brodalumab (n = 4019; 3446 total PY of exposure) than with ustekinumab (n = 613; 495 total PY of exposure), including adjudicated malignancies (0.9 vs 2.6) and Surveillance, Epidemiology, and End Results (SEER)-adjudicated malignancies (0.3 vs 0.4).","[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Gottlieb', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, 10 Union Square East, New York, NY, 10003, USA. alice.gottlieb@mountsinai.org.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lebwohl', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, 10 Union Square East, New York, NY, 10003, USA.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Bellevue Dermatology Clinic, Bellevue, WA, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Israel', 'Affiliation': 'Bausch Health US, LLC, Bridgewater, NJ, USA.'}, {'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Jacobson', 'Affiliation': 'Ortho Dermatologics, Bridgewater, NJ, USA.'}]",American journal of clinical dermatology,['10.1007/s40257-020-00512-4']
739,32402832,Transrectal Natural Orifice Specimen Extraction (NOSE) With Oncological Safety: A Prospective and Randomized Trial.,"BACKGROUND


In the present paper, we introduce our experience with the novel method during laparoscopic anterior resection of upper rectal or sigmoid colon cancer by transrectal natural orifice specimen extraction (NOSE).
METHODS


A prospective randomized controlled trial was performed from June 2016 to May 2019. Patients with upper rectal or sigmoid colon cancer were randomized in a 1:1 ratio to the NOSE group and the non-NOSE group. Preoperative and postoperative clinical variables were analyzed and compared between groups. Postoperative pain was analyzed utilizing a visual analog scale. Postoperative overall survival was analyzed using a Kaplan-Meier curve.
RESULTS


A total of 276 patients were enrolled, of whom 254 were randomly divided into the NOSE group (n = 122) and the conventional laparoscopic group (n = 119). NOSE failed in 22 cases, which were converted to transabdominal specimen extraction. Intention-to-treat analysis was performed, and these 22 cases were included in the NOSE group. The incidence of postoperative complications was significantly lower in the NOSE group (11/122, 9%) than in the non-NOSE group (25/119, 21%). The NOSE group had a longer operation time, less blood loss, and a lower postoperative visual analog scale score than the non-NOSE group. The time for intestinal function recovery (ventilation) and the length of hospital stay were significantly longer in the non-NOSE group. The Kaplan-Meier survival curve showed no statistically significant difference in the disease-free survival rate between the NOSE group and the non-NOSE group.
CONCLUSIONS


The novel NOSE method is safe and feasible to use in patients having colorectal cancer. Compared with traditional laparoscopic surgery, the postoperative complication rates of NOSE surgery were lower with an improved short-term clinical recovery.",2020,"The Kaplan-Meier survival curve showed no statistically significant difference in the disease-free survival rate between the NOSE group and the non-NOSE group.
","['June 2016 to May 2019', 'patients having colorectal cancer', '22 cases were included in the NOSE group', 'Patients with upper rectal or sigmoid colon cancer', 'A total of 276 patients were enrolled, of whom 254']","['conventional laparoscopic group', 'traditional laparoscopic surgery', 'laparoscopic anterior resection of upper rectal or sigmoid colon cancer by transrectal natural orifice specimen extraction (NOSE', 'Transrectal Natural Orifice Specimen Extraction (NOSE', 'NOSE']","['incidence of postoperative complications', 'longer operation time, less blood loss', 'postoperative complication rates of NOSE surgery', 'time for intestinal function recovery (ventilation) and the length of hospital stay', 'disease-free survival rate', 'postoperative visual analog scale score', 'Postoperative overall survival', 'Postoperative pain']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0153436', 'cui_str': 'Malignant tumor of sigmoid colon'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0153436', 'cui_str': 'Malignant tumor of sigmoid colon'}, {'cui': 'C0205518', 'cui_str': 'Transrectal approach'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",276.0,0.0637219,"The Kaplan-Meier survival curve showed no statistically significant difference in the disease-free survival rate between the NOSE group and the non-NOSE group.
","[{'ForeName': 'Zhu-Qing', 'Initials': 'ZQ', 'LastName': 'Zhou', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Kaijing', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Du', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Qixin', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Ji', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Chuan-Gang', 'Initials': 'CG', 'LastName': 'Fu', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China. Electronic address: fugang416@126.com.'}]",The Journal of surgical research,['10.1016/j.jss.2020.03.064']
740,32163509,Trauma-affected refugees treated with basic body awareness therapy or mixed physical activity as augmentation to treatment as usual-A pragmatic randomised controlled trial.,"BACKGROUND


The prevalence of post-traumatic stress disorder (PTSD) is estimated to be as high as 30% among refugees. The coexistence of prevalent chronic pain is believed to maintain symptoms of PTSD and add complexity to the condition. Despite this, little evidence exists on how to treat PTSD and comorbid conditions best in trauma-affected refugees.
AIM


The aim of the present study was to investigate if adding either BBAT or mixed physical activity to the treatment as usual (TAU) for trauma-affected refugees with PTSD would increase the treatment effect compared to TAU alone.
METHOD


Randomised controlled trial, 3-armed parallel group superiority study, conducted at Competence Centre for Transcultural Psychiatry, Denmark. Participants were adult trauma-affected refugees with PTSD. Allocation ratio was 1:1:1, stratified for PTSD severity and gender. An open-label design was applied due to the nature of the intervention. Participants were randomised to receive either individual basic body awareness therapy (group B) or individual mixed physical activity (group M) one hour/week for 20 weeks plus TAU, or TAU only (group C). The primary outcome was PTSD severity measured by Harvard Trauma Questionnaire (HTQ). Trial registration: ClinicalTrials.gov, NCT01955538.
RESULTS


Of the 338 patients included (C/B/M = 110/114/114), 318 patients were eligible for intention-to-treat analysis (C/B/M = 104/105/109). On the primary outcome, intention-to-treat as well as per-protocol analyses showed small but significant improvement on scores from pre- to post-treatment in all three groups but with no significant difference in improvement between groups.
CONCLUSIONS


The findings do not provide evidence that either BBAT or mixed physical activity as add-on treatment bring significantly larger improvement on symptoms of PTSD compared to TAU alone for adult, trauma-affected refugees. There is a need for studies on potential subpopulations of trauma-affected refugees who could benefit from physical activity as a part of their treatment.",2020,"The findings do not provide evidence that either BBAT or mixed physical activity as add-on treatment bring significantly larger improvement on symptoms of PTSD compared to TAU alone for adult, trauma-affected refugees.","['Participants were adult trauma-affected refugees with PTSD', 'conducted at Competence Centre for Transcultural Psychiatry, Denmark', '338 patients included (C/B/M = 110/114/114', '318 patients were eligible for intention-to-treat analysis (C/B/M = 104/105/109']","['individual basic body awareness therapy (group B) or individual mixed physical activity (group M) one hour/week for 20 weeks plus TAU, or TAU', 'basic body awareness therapy or mixed physical activity', 'BBAT']","['intention-to-treat', 'PTSD severity measured by Harvard Trauma Questionnaire (HTQ']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0871538', 'cui_str': 'Ethnopsychiatry'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0441847', 'cui_str': 'Group M (qualifier value)'}, {'cui': 'C0556976', 'cui_str': 'hours/week (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",318.0,0.116662,"The findings do not provide evidence that either BBAT or mixed physical activity as add-on treatment bring significantly larger improvement on symptoms of PTSD compared to TAU alone for adult, trauma-affected refugees.","[{'ForeName': 'Maja Sticker', 'Initials': 'MS', 'LastName': 'Nordbrandt', 'Affiliation': 'Competence Centre for Transcultural Psychiatry, Mental Health Centre Ballerup, Mental Health Services of the Capital Region, Ballerup, Denmark.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Sonne', 'Affiliation': 'Competence Centre for Transcultural Psychiatry, Mental Health Centre Ballerup, Mental Health Services of the Capital Region, Ballerup, Denmark.'}, {'ForeName': 'Erik Lykke', 'Initials': 'EL', 'LastName': 'Mortensen', 'Affiliation': 'Department of Public Health and Center for Healthy Aging, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Carlsson', 'Affiliation': 'Competence Centre for Transcultural Psychiatry, Mental Health Centre Ballerup, Mental Health Services of the Capital Region, Ballerup, Denmark.'}]",PloS one,['10.1371/journal.pone.0230300']
741,32201141,"Validating the Transfer of Skills Acquired on a Prostate Biopsy Simulator: A Prospective, Randomized, Controlled Study.","OBJECTIVES


To evaluate the ability of students to reproduce the skills acquired on a prostate biopsy simulator in a real-life situation.
DESIGN


A prospective randomized controlled study was conducted. Medical students with no experience of prostate biopsy were randomized between arm A « conventional training » and arm B « simulator-enhanced training. » The training was performed for both groups on the simulator. The students in arm B were provided with visual and numerical feedback. The transfer of skills was assessed by recording the position of the 12 biopsies performed by each student on an unembalmed human cadaver using a 3D ultrasound mapping device.
SETTING


The study was conducted in an academic urology department and the cadaver experiments in the adjoining anatomy laboratory.
RESULTS


Twenty-four students were included, and 22 completed the study. The median score obtained on the simulator at the end of the training was 57% (53-61) for arm A and 66% (59-71) for arm B. The median score obtained on the cadaver by students trained with the simulator was 75% (60-80), statistically superior to the score obtained by students trained conventionally of 45% (30-60), p < 0.0001. The median score obtained by all students when performing biopsies in a real-life situation was 63% (50-80) versus 60% (56-70) for their last training on the simulator.
CONCLUSION


These results support the transfer of skills acquired on the simulator, and the superiority of a training curriculum integrating simulation, and performance feedback.",2020,The median score obtained on the simulator at the end of the training was 57% (53-61) for arm A and 66% (59-71) for arm B.,"['Medical students with no experience of prostate biopsy', 'The study was conducted in an academic urology department and the cadaver experiments in the adjoining anatomy laboratory', 'Twenty-four students were included, and 22 completed the study']",['conventional training » and arm B « simulator-enhanced training'],[],"[{'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0587531', 'cui_str': 'Urology department (environment)'}, {'cui': 'C0006629', 'cui_str': 'Corpse'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}]",[],24.0,0.0303468,The median score obtained on the simulator at the end of the training was 57% (53-61) for arm A and 66% (59-71) for arm B.,"[{'ForeName': 'Gaelle', 'Initials': 'G', 'LastName': 'Fiard', 'Affiliation': 'Department of Urology, Grenoble Alpes University Hospital, Grenoble, France; University Grenoble Alpes, CNRS, Grenoble INP, CNRS, Grenoble, France. Electronic address: GFiard@chu-grenoble.fr.'}, {'ForeName': 'Sonia-Yuki', 'Initials': 'SY', 'LastName': 'Selmi', 'Affiliation': 'University Grenoble Alpes, CNRS, Grenoble INP, CNRS, Grenoble, France.'}, {'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Maigron', 'Affiliation': 'Department of Urology, Grenoble Alpes University Hospital, Grenoble, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Bellier', 'Affiliation': 'LADAF (Anatomy Laboratory of the French Alps), Grenoble Alpes University Hospital, Grenoble, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Promayon', 'Affiliation': 'University Grenoble Alpes, CNRS, Grenoble INP, CNRS, Grenoble, France.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Descotes', 'Affiliation': 'Department of Urology, Grenoble Alpes University Hospital, Grenoble, France; University Grenoble Alpes, CNRS, Grenoble INP, CNRS, Grenoble, France.'}, {'ForeName': 'Jocelyne', 'Initials': 'J', 'LastName': 'Troccaz', 'Affiliation': 'University Grenoble Alpes, CNRS, Grenoble INP, CNRS, Grenoble, France.'}]",Journal of surgical education,['10.1016/j.jsurg.2020.01.008']
742,32213306,Long-term safety of nine systemic medications for psoriasis: A cohort study using the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry.,"BACKGROUND


Registry studies broadly describing the safety of systemic drugs in psoriasis are needed.
OBJECTIVE


To describe the safety findings of the systemic drugs acitretin, adalimumab, apremilast, cyclosporine, etanercept, infliximab, methotrexate, secukinumab, and ustekinumab used for the treatment of moderate to severe psoriasis in patients included in the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry.
METHODS


The incidence rate ratio (IRR) and adjusted IRR (including propensity scores) of identified adverse events for each drug, using methotrexate as reference, were determined by means of a prospective cohort.
RESULTS


Our study included 2845 patients (8954 treatment cycles; 9642 patient-years). Ustekinumab and secukinumab had the lowest rate of adverse events for several of the system organ classes, with a statistically significant decreased rate ratio (IRR of <1), whereas cyclosporine and infliximab had the highest, with an increased rate ratio (IRR of ≥5).
LIMITATIONS


Observational study, drug allocation not randomized, depletion of susceptibles, and prescribed doses not registered.
CONCLUSION


Our data provide comparative safety information in the real-life setting that could help clinicians selecting between available products.",2020,"Ustekinumab and secukinumab had the lowest rate of adverse events for several of the system organ class with statistically significant decreased rate ratio (IRR<1), whereas cyclosporine and infliximab had the highest, with increased rate ratio (IRR ≥ 5).
","['2,845 patients (8,954 treatment cycles; 9,642 patient-years', 'moderate-to-severe psoriasis in patients included in Biobadaderm', 'psoriasis']","['nine systemic medications', 'systemic drugs (acitretin, adalimumab, apremilast, cyclosporine, etanercept, infliximab, methotrexate, secukinumab, ustekinumab', 'cyclosporine']","['rate ratio (IRR<1', 'rate ratio (IRR ≥ 5', 'lowest rate of adverse events', 'incidence rate ratio (IRR) and adjusted IRR (including propensity scores) of identified adverse events (AE']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0050559', 'cui_str': 'Acitretin'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C1678805', 'cui_str': 'apremilast'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0083017', 'cui_str': 'IRR'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718044', 'cui_str': 'Propensity Score'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}]",2845.0,0.0698521,"Ustekinumab and secukinumab had the lowest rate of adverse events for several of the system organ class with statistically significant decreased rate ratio (IRR<1), whereas cyclosporine and infliximab had the highest, with increased rate ratio (IRR ≥ 5).
","[{'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Daudén', 'Affiliation': 'Department of Dermatology, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria de La Princesa (IIS-IP), Madrid, Spain. Electronic address: estebandauden@gmail.com.'}, {'ForeName': 'Gregorio', 'Initials': 'G', 'LastName': 'Carretero', 'Affiliation': 'Department of Dermatology, Hospital Universitario de Gran Canaria Dr. Negrín, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Rivera', 'Affiliation': 'Department of Dermatology, Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ferrándiz', 'Affiliation': 'Department of Dermatology, Hospital Universitari Germans Trias i Pujol, Badalona, and Universidad Autónoma de Barcelona, Badalona, Spain.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Llamas-Velasco', 'Affiliation': 'Department of Dermatology, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria de La Princesa (IIS-IP), Madrid, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'de la Cueva', 'Affiliation': 'Department of Dermatology, Hospital Universitario Infanta Leonor, Madrid, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Belinchón', 'Affiliation': 'Department of Dermatology, Hospital General Universitario de Alicante, Alicante, Spain.'}, {'ForeName': 'Francisco José', 'Initials': 'FJ', 'LastName': 'Gómez-García', 'Affiliation': 'Department of Dermatology, Hospital Universitario Reina Sofía, Cordoba, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Herrera-Acosta', 'Affiliation': 'Department of Dermatology, Hospital Universitario Virgen de la Victoria, Málaga, Spain.'}, {'ForeName': 'Diana Patricia', 'Initials': 'DP', 'LastName': 'Ruiz-Genao', 'Affiliation': 'Department of Dermatology, Hospital Universitario Fundación Alcorcón, Madrid, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Ferrán-Farrés', 'Affiliation': 'Department of Dermatology, Hospital del Mar, Parc de Salut Mar, Barcelona, Spain.'}, {'ForeName': 'Mercè', 'Initials': 'M', 'LastName': 'Alsina', 'Affiliation': 'Department of Dermatology, Hospital Clínic de Barcelona, UB, Barcelona, Spain.'}, {'ForeName': 'Ofelia', 'Initials': 'O', 'LastName': 'Baniandrés-Rodríguez', 'Affiliation': 'Department of Dermatology, Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Sánchez-Carazo', 'Affiliation': 'Department of Dermatology, Hospital General Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Sahuquillo-Torralba', 'Affiliation': 'Department of Dermatology, Hospital Universitario y Politécnico La Fe, Instituto de Investigación Sanitaria La Fe (IIS La Fe), Valencia, Spain.'}, {'ForeName': 'Lourdes Rodriguez', 'Initials': 'LR', 'LastName': 'Fernández-Freire', 'Affiliation': 'Department of Dermatology, Hospital Virgen del Rocío, Sevilla, Spain.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Vilar-Alejo', 'Affiliation': 'Department of Dermatology, Hospital Universitario de Gran Canaria Dr. Negrín, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'García-Donoso', 'Affiliation': 'Department of Dermatology, Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Carrascosa', 'Affiliation': 'Department of Dermatology, Hospital Universitari Germans Trias i Pujol, Badalona, and Universidad Autónoma de Barcelona, Badalona, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Herrera-Ceballos', 'Affiliation': 'Department of Dermatology, Hospital Universitario Virgen de la Victoria, Málaga, Spain.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'López-Estebaranz', 'Affiliation': 'Department of Dermatology, Hospital Universitario Fundación Alcorcón, Madrid, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Botella-Estrada', 'Affiliation': 'Department of Dermatology, Hospital Universitario y Politécnico La Fe, Instituto de Investigación Sanitaria La Fe (IIS La Fe), Universidad de Valencia, Valencia, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Segovia-Muñoz', 'Affiliation': 'Evaluation Unit, Pharmacovigilance Department, Spanish Medicines and Health Products Agency (AEMPS), Madrid, Spain.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Descalzo', 'Affiliation': 'Research Unit, Fundación Piel Sana Academia Española de Dermatología, Madrid, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'García-Doval', 'Affiliation': 'Research Unit, Fundación Piel Sana Academia Española de Dermatología, Madrid, Spain; Department of Dermatology, Complexo Hospitalario Universitario de Vigo, Vigo, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.03.033']
743,31469914,Combination of photodynamic therapy with 5-aminolaevulinic acid and microneedling in the treatment of alopecia areata resistant to conventional therapies: our experience with 41 patients.,"Alopecia areata (AA) is a complex immune-mediated disorder, which is difficult to treat. The available treatment options seem to have limited benefit, help only some patients and have a high relapse rate. We evaluated a new therapeutic option for moderate to severe AA based on the combination of photodynamic therapy (PDT) with 5-aminolaevulinic acid (ALA) and microneedling (MN). In total, 14 patients were enrolled, and these were randomly divided into 3 groups: Group A (MN alone; n = 9), Group B (ALA-PDT alone; n = 15) and Group C (combination of MN and ALA-PDT; n = 17). All patients were treated once every 3 weeks for a total of six treatments. The best clinical outcome was achieved in Group C, with complete hair regrowth observed in three patients, and an improvement of ≥ 50% and < 50% of the treated areas obtained in seven and six patients, respectively. Our report suggests that combination of ALA-PDT with MN could be an additional therapeutic option in moderate to severe AA, as MN allows better skin penetration of ALA and subsequent indirect immunosuppression.",2020,"The best clinical outcome was achieved in Group-C, with complete hair regrowth observed in 3 patients, an improvement >50% and <50% of the treated areas obtained in 7 and 6 patients, respectively.","['41 patients', 'Alopecia areata (AA']","['ALA-PDT with MN', 'photodynamic therapy with 5-aminolevulinic acid and micro-needling', 'photodynamic therapy (PDT) with 5-aminolevulinic acid (ALA) and micro-needling (MN', 'MN alone (9 patients); Group-B, treated with ALA-PDT (15 patients); Group-C, treated with MN and ALA-PDT']",['complete hair regrowth'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002171', 'cui_str': 'Alopecia Circumscripta'}]","[{'cui': 'C0044588', 'cui_str': 'PDT'}, {'cui': 'C0031740', 'cui_str': 'Photodynamic Therapy'}, {'cui': 'C0002563', 'cui_str': 'Aminolevulinic Acid'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0018494', 'cui_str': 'Hair'}]",41.0,0.0218018,"The best clinical outcome was achieved in Group-C, with complete hair regrowth observed in 3 patients, an improvement >50% and <50% of the treated areas obtained in 7 and 6 patients, respectively.","[{'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Giorgio', 'Affiliation': 'Dermatology Unit, University of Campania Luigi Vanvitelli, Naples, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Babino', 'Affiliation': 'Dermatology Unit, University of Campania Luigi Vanvitelli, Naples, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Caccavale', 'Affiliation': 'Dermatology Unit, University of Campania Luigi Vanvitelli, Naples, Italy.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Russo', 'Affiliation': 'Dermatology Unit, University of Campania Luigi Vanvitelli, Naples, Italy.'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'De Rosa', 'Affiliation': 'Dermatology Unit, University of Campania Luigi Vanvitelli, Naples, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Alfano', 'Affiliation': 'Department of Anesthesiology, Surgery and Emergency, University of Campania Luigi Vanvitelli, Naples, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Fulgione', 'Affiliation': 'Dermatology Unit, University of Campania Luigi Vanvitelli, Naples, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Argenziano', 'Affiliation': 'Dermatology Unit, University of Campania Luigi Vanvitelli, Naples, Italy.'}]",Clinical and experimental dermatology,['10.1111/ced.14084']
744,32195960,Combined effect of laser acupuncture and electroacupuncture in knee osteoarthritis patients: A protocol for a randomized controlled trial.,"BACKGROUND


Knee osteoarthritis (KOA) is a common degenerative joint disorder that affects 250 million people globally. KOA can lead to disability and is often associated with cardiovascular disease, poor quality of life, and mortality. The most common treatment for KOA is non-steroidal anti-inflammatory drug administration. However, the analgesic effect is limited and often accompanied by multiple side effects. Hence, many KOA patients opt for complementary and alternative medicine. Acupuncture is one of the most popular complementary treatments with great analgesic effect and minimal side effect. Electroacupuncture (EA) and laser acupuncture (LA) have been known to reduce pain in KOA patients. However, to date, no study has assessed the benefits of combining these two therapies.
METHODS


Fifty participants diagnosed with KOA, aged 50 years or older, and with consistent knee pain for more than 3 months were recruited and randomly assigned to the treatment group (EA plus LA) or control group (EA plus sham LA without laser output). All subjects in the treatment group will undergo a combined EA and LA treatment thrice a week for 4 weeks. The acupuncture will be performed on GB33, GB34, SP9, SP10, and ST36 sites. The treatment group will receive acupuncture with a transcutaneous electrical nerve stimulator at GB33, GB34, SP9, and SP10 sites and with LA at EX-LE5, ST35, and BL40 sites. The subjects in the control group will undergo the same treatment modality as the treatment group, except these subjects will not be exposed to laser output. Outcome measurements will include visual analog scale, Western Ontario McMaster Universities Osteoarthritis Index, Knee injury and osteoarthritis outcome, body composition analysis, knee range of motion, quadriceps muscle stiffness, one-leg standing with eyes open test, and the 30-s chair stand test before and after 4 weeks of intervention.
OBJECTIVES


This protocol aims to investigate the combined effect of EA and LA in KOA patients.",2020,Electroacupuncture (EA) and laser acupuncture (LA) have been known to reduce pain in KOA patients.,"['knee osteoarthritis patients', 'Fifty participants diagnosed with KOA, aged 50 years or older, and with consistent knee pain for more than 3 months', 'KOA patients']","['Electroacupuncture (EA) and laser acupuncture (LA', 'laser acupuncture and electroacupuncture', 'combined EA and LA', 'Acupuncture', 'KOA', 'treatment group (EA plus LA) or control group (EA plus sham LA without laser output', 'EA and LA', 'acupuncture with a transcutaneous electrical nerve stimulator at GB33, GB34, SP9, and SP10 sites and with LA at EX-LE5, ST35, and BL40 sites']","['visual analog scale, Western Ontario McMaster Universities Osteoarthritis Index, Knee injury and osteoarthritis outcome, body composition analysis, knee range of motion, quadriceps muscle stiffness, one-leg standing with eyes open test, and the 30-s chair stand test']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0394654', 'cui_str': 'Laser acupuncture (regime/therapy)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0491576', 'cui_str': 'Transcutaneous electrical nerve stimulator'}, {'cui': 'C0450753', 'cui_str': 'GB33 (body structure)'}, {'cui': 'C0450754', 'cui_str': 'GB34 (body structure)'}, {'cui': 'C0450551', 'cui_str': 'SP9 (body structure)'}, {'cui': 'C0450552', 'cui_str': 'SP10 (body structure)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0450532', 'cui_str': 'ST35 (body structure)'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0576094', 'cui_str': 'Knee range of motion'}, {'cui': 'C0221170', 'cui_str': 'Muscular stiffness'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}]",50.0,0.0546208,Electroacupuncture (EA) and laser acupuncture (LA) have been known to reduce pain in KOA patients.,"[{'ForeName': 'Szu-Ying', 'Initials': 'SY', 'LastName': 'Wu', 'Affiliation': 'Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung.'}, {'ForeName': 'Chien-Hung', 'Initials': 'CH', 'LastName': 'Lin', 'Affiliation': 'Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung.'}, {'ForeName': 'Nai-Jen', 'Initials': 'NJ', 'LastName': 'Chang', 'Affiliation': 'Department of Sports Medicine.'}, {'ForeName': 'Wen-Long', 'Initials': 'WL', 'LastName': 'Hu', 'Affiliation': 'Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung.'}, {'ForeName': 'Yu-Chiang', 'Initials': 'YC', 'LastName': 'Hung', 'Affiliation': 'Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Tsao', 'Affiliation': 'College of Management, National Kaohsiung University of Science and Technology.'}, {'ForeName': 'Chun-En Aurea', 'Initials': 'CA', 'LastName': 'Kuo', 'Affiliation': 'Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung.'}]",Medicine,['10.1097/MD.0000000000019541']
745,32195961,Photobiomodulation by low-level laser therapy in patients with obstructive sleep apnea: Study protocol clinical trial (SPIRIT compliant).,"Obstructive sleep apnea (OSA) increases morbidity and mortality and it is associated with an increased cardiovascular risk. The gold standard treatment for OSA is positive airway pressure therapy (CPAP). However, it is an expensive treatment and several patients do not adapt to CPAP.
GOAL


The researchers will verify the effects of low-level laser therapy (LLLT) on OSA, when applied to the soft palate and on the tongue base.
METHODS


The researchers will select individuals of both sexes aged 30 to 60 years old who are sedentary and that present a high risk of OSA by the Berlin questionnaire. The evaluations pre and post interventions will be polysomnography; anthropometric and body composition measurements (Bioimpedance); metabolic syndrome risk factors (International Diabetes Federation); physical capacity (VO2 peak at the cardiopulmonary exercise test, CPET); endothelial function (flow-mediated dilatation, FMD); autonomic control (heart rate variability and sympathovagal balance). Those diagnosed with moderate and severe OSA (apnea/hypopnea index, AHI ≥15 events/h) will be invited to participate in the study and they will be randomized into 2 groups: LLLT treatment or placebo (C). The LLLT group will receive applications at 8 points on the soft palate and on the base of the tongue for 8 seconds for each point. The applications of LLLT will occur twice a week, with a minimum interval of 2 days between the applications for 2 months, when using a Therapy Plus NS 13678 Laser. The C group will have similar applications, but with the device turned off.
EXPECTED RESULTS


In the individuals with OSA, photobiomodulation through LLLT will decrease the AHI. Additionally, when LLLT is applied in the oral cavity, a highly vascularized region, this may cause improvements in the vascular function and in the autonomic and hemodynamic control.
ETHICS AND DISSEMINATION


This protocol was approved by the Research Ethics Committee of the Nove de Julho University, São Paulo, Brazil, on the date of March 11, 2019 (CAAE: 06025618.2.0000.5511 - Acceptance Number: 3.191.077). This trial has been registered with the Brazilian Registry of Clinical Trials (REBEC TRIAL RBR-42v548). This study is not yet recruiting. Issue date: November 4, 2019.",2020,"The researchers will verify the effects of low-level laser therapy (LLLT) on OSA, when applied to the soft palate and on the tongue base.
","['patients with obstructive sleep apnea', 'individuals of both sexes aged 30 to 60 years old who are sedentary and that present a high risk of OSA by the Berlin questionnaire']","['low-level laser therapy (LLLT', 'LLLT treatment or placebo (C', 'LLLT', 'Photobiomodulation by low-level laser therapy']","['polysomnography; anthropometric and body composition measurements (Bioimpedance); metabolic syndrome risk factors (International Diabetes Federation); physical capacity (VO2 peak at the cardiopulmonary exercise test, CPET); endothelial function (flow-mediated dilatation, FMD); autonomic control (heart rate variability and sympathovagal balance', 'Obstructive sleep apnea']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0279027', 'cui_str': 'Low-Power Laser Therapy'}, {'cui': 'C4019433', 'cui_str': 'LLLT'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1701256', 'cui_str': 'bis(acetylacetonato)oxovanadium(IV)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}, {'cui': 'C0055954', 'cui_str': 'CPET'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]",,0.0450266,"The researchers will verify the effects of low-level laser therapy (LLLT) on OSA, when applied to the soft palate and on the tongue base.
","[{'ForeName': 'Fernanda Cristina Ferreira', 'Initials': 'FCF', 'LastName': 'de Camargo', 'Affiliation': 'Graduate Program in Medicine, University Nove de Julho.'}, {'ForeName': 'José Roberto', 'Initials': 'JR', 'LastName': 'DeMoura', 'Affiliation': 'Graduate Program in Medicine, University Nove de Julho.'}, {'ForeName': 'Felipe Xerez', 'Initials': 'FX', 'LastName': 'Cepeda', 'Affiliation': 'Graduate Program in Medicine, University Nove de Julho.'}, {'ForeName': 'Marilia', 'Initials': 'M', 'LastName': 'de Almeida Correia', 'Affiliation': 'Graduate Program in Medicine, University Nove de Julho.'}, {'ForeName': 'Reginaldo Ceolin', 'Initials': 'RC', 'LastName': 'Nascimento', 'Affiliation': 'Graduate Program in Medicine, University Nove de Julho.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Fortes-Queiroz', 'Affiliation': 'Graduate Program in Medicine, University Nove de Julho.'}, {'ForeName': 'Fabiana Gonçalves', 'Initials': 'FG', 'LastName': 'Ferreira', 'Affiliation': 'Graduate Program in Medicine, University Nove de Julho.'}, {'ForeName': 'Renata Kelly da', 'Initials': 'RKD', 'LastName': 'Palma', 'Affiliation': 'Graduate Program in Medicine, University Nove de Julho.'}, {'ForeName': 'Maria Fernanda', 'Initials': 'MF', 'LastName': 'Hussid', 'Affiliation': 'Graduate Program in Medicine, University Nove de Julho.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Chavantes', 'Affiliation': 'Graduate Program in Medicine, University Nove de Julho.'}, {'ForeName': 'Ivani Credidio', 'Initials': 'IC', 'LastName': 'Trombetta', 'Affiliation': 'Graduate Program in Medicine, University Nove de Julho.'}]",Medicine,['10.1097/MD.0000000000019547']
746,32195962,A tablet computer-based cognitive training program for young children with cognitive impairment: A randomized controlled trial.,"BACKGROUND


Evidences suggest that cognitive training facilitates cognitive function, and most studies have targeted adults and children older than 4 years of age. This study investigated the applicability and efficacy of a tablet computer-based cognitive training program for young children with cognitive impairment of cognitive age between 18 and 36 months.
METHODS


Thirty-eight children were randomly assigned to the intervention (n = 20, administered a tablet computer-based cognitive training program, for 30 minutes per session and twice a week over a period of 12 weeks) and control (n = 18, received the traditional rehabilitation program) groups. Mental scale of Bayley Scales of Infant Development II (BSID II), Pediatric Evaluation of Disability Inventory (PEDI), interest/persistence domain of the Laboratory Temperament Assessment Battery (LAP-TAB), Early Childhood Behavior Questionnaire (ECBQ), and Goal Attainment Scale (GAS) were evaluated before and after 12 weeks of therapeutic intervention.
RESULTS


The tablet computer-based cognitive training program was applicable to all children in the intervention group without any problems including irritable behavior or obsession about a tablet computer. After 12 weeks, Mental scale of BSID II, PEDI (social function), LAB-TAB (observation), LAB-TAB (manipulation), and GAS showed statistically significant improvements in the intervention group, compared with the values in the control group (P < .05). After adjusting for the pre-treatment measurements and cognitive age, the tablet computer-based cognitive training program had significant effect on the post-treatment measurements of Mental scale of BSID II, PEDI (social function), LAB-TAB (observation), LAB-TAB (manipulation), and GAS (P < .05). There was no association between the change in the scores and the severity of cognitive delay in the most of the measurements, however, the self-care domain of PEDI showed a negative association with the severity of the cognitive delay (r = -0.462, P = .04).
CONCLUSIONS


Application of a tablet computer-based cognitive training program was feasible and showed improvements in cognitive function in young children with cognitive impairment of cognitive age between 18 and 36 months, regardless of the severity of the cognitive delay. But severe cognitive delay can be related with less improvement in the self-care domain of PEDI.
TRIAL REGISTRATION NUMBER


https://cris.nih.go.kr (KCT0002889).",2020,The tablet computer-based cognitive training program was applicable to all children in the intervention group without any problems including irritable behavior or obsession about a tablet computer.,"['Thirty-eight children', 'young children with cognitive impairment', 'young children with cognitive impairment of cognitive age between 18 and 36 months', 'adults and children older than 4 years of age']","['intervention group without any problems including irritable behavior or obsession about a tablet computer', 'tablet computer-based cognitive training program', 'cognitive training', 'control (n\u200a=\u200a18, received the traditional rehabilitation program']","['cognitive function', 'Mental scale of Bayley Scales of Infant Development II (BSID II), Pediatric Evaluation of Disability Inventory (PEDI), interest/persistence domain of the Laboratory Temperament Assessment Battery (LAP-TAB), Early Childhood Behavior Questionnaire (ECBQ), and Goal Attainment Scale (GAS', 'severity of the cognitive delay', 'severity of cognitive delay', 'Mental scale of BSID II, PEDI (social function), LAB-TAB (observation), LAB-TAB (manipulation), and GAS']","[{'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0233697', 'cui_str': 'Obsessions'}, {'cui': 'C4045980', 'cui_str': 'Tablet Computers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0222045'}, {'cui': 'C0451021', 'cui_str': 'Bayley scale of infant development (assessment scale)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0546816', 'cui_str': 'Persistence (finding)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0039474', 'cui_str': 'Temperament'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",38.0,0.0130342,The tablet computer-based cognitive training program was applicable to all children in the intervention group without any problems including irritable behavior or obsession about a tablet computer.,"[{'ForeName': 'Eun Jae', 'Initials': 'EJ', 'LastName': 'Ko', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan.'}, {'ForeName': 'In Young', 'Initials': 'IY', 'LastName': 'Sung', 'Affiliation': 'Department of Rehabilitation Medicine, Asan Medical Center, University of Ulsan College of Medicine.'}, {'ForeName': 'Jin Sook', 'Initials': 'JS', 'LastName': 'Yuk', 'Affiliation': 'Department of Rehabilitation Medicine, Asan Medical Center, Seoul.'}, {'ForeName': 'Dae-Hyun', 'Initials': 'DH', 'LastName': 'Jang', 'Affiliation': ""Department of Rehabilitation, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Incheon.""}, {'ForeName': 'Gijeong', 'Initials': 'G', 'LastName': 'Yun', 'Affiliation': 'Department of Rehabilitation Medicine, Gamcheon Champyonhan Geriatric Hospital, Pusan, Republic of Korea.'}]",Medicine,['10.1097/MD.0000000000019549']
747,32217018,Analysis of the Socio-Personal Profile of Latin Americans Living in Spain and the United States: Does It Justify the Differences in Attitude Toward Organ Donation?,"INTRODUCTION


There are differences in the attitude toward organ donation between Latin Americans living in Spain and those living in the United States.
OBJECTIVE


We sought to analyze the socio-personal factors that can condition the difference in attitude toward donation between Latin Americans living in the United States and those living in Spain.
MATERIALS AND METHODS


Participants in the study were Latin Americans living in Spain (group A; n=1237) and the United States (Florida) (group B; n=1450), extracted from the database of the International Collaborative Donor Project (PCID). Inclusion criteria were a sample population stratified by area, country of birth, age, and sex. The instrument used was a validated attitude questionnaire toward living kidney donation (PCID-DTO-Rios.) Participants were randomly selected to be surveyed according to stratification.
RESULTS


The attitude in favor of Latin Americans residing in Spain (group A) was 60% (n=745) vs 33% (n=485) of residents in the United States (group B) (P < .001). The socio-personal profile of the Latin Americans in Spain compared with those in the United States indicates that they are mainly women (63.5% vs 43.7%, respectively), younger (31.78 vs 37.31 years, respectively), have more secondary education (21.2% vs 16.3%, respectively) and university studies (11% vs 6%, respectively), are of South American origin vs those who are Mexican and Central American, respectively, and there is a higher percentage of atheists/agnostics (8.1% vs 3.7%). However, the personal profile toward donation is similar in both groups, both for and against organ donation.
CONCLUSIONS


The personal social profile of the Latin American resident in Spain is different from that of the resident in the United States. However, the psycho-social profile for and against organ donation is similar in both countries.",2020,The attitude in favor of Latin Americans residing in Spain (group A) was 60% (n=745) vs 33% (n=485) of residents in the United States (group B),"['Latin Americans living in the United States and those living in Spain', 'Latin Americans Living in Spain and the United States', 'Latin Americans residing in Spain (group A) was 60% (n=745) vs 33% (n=485) of residents in the United States (group B', 'Participants in the study were Latin Americans living in Spain (group A; n=1237) and the United States (Florida) (group B; n=1450), extracted from the database of the International Collaborative Donor Project (PCID', 'Inclusion criteria were a sample population stratified by area, country of birth, age, and sex']",[],"['attitude questionnaire toward living kidney donation (PCID-DTO-Rios', 'secondary education']","[{'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1277523', 'cui_str': 'Country of birth - Australasian (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]",[],"[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C4049936', 'cui_str': 'Donation'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",,0.0369331,The attitude in favor of Latin Americans residing in Spain (group A) was 60% (n=745) vs 33% (n=485) of residents in the United States (group B),"[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ríos', 'Affiliation': 'International Collaborative Donor Project (""Proyecto Colaborativo Internacional Donante""), Murcia, Spain; Transplant Unit, Surgery Service, IMIB - Virgen de la Arrixaca University Clinical Hospital, Murcia, Spain. Electronic address: arzrios@um.es.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Carrillo', 'Affiliation': 'International Collaborative Donor Project (""Proyecto Colaborativo Internacional Donante""), Murcia, Spain.'}, {'ForeName': 'Ana I', 'Initials': 'AI', 'LastName': 'López-Navas', 'Affiliation': 'Department of Psychology, Catholic University of Murcia (UCAM), Murcia, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Flores-Medina', 'Affiliation': 'Department of Psychology, Catholic University of Murcia (UCAM), Murcia, Spain.'}, {'ForeName': 'Marco Antonio', 'Initials': 'MA', 'LastName': 'Ayala-García', 'Affiliation': 'International Collaborative Donor Project (""Proyecto Colaborativo Internacional Donante""), Murcia, Spain; School of Medicine of the University of Quetzalcoatl in Irapuato, Guanajuato, Mexico.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Martinez-Insfran', 'Affiliation': 'Transplant Unit, Surgery Service, IMIB - Virgen de la Arrixaca University Clinical Hospital, Murcia, Spain.'}, {'ForeName': 'Pascual', 'Initials': 'P', 'LastName': 'Parrilla', 'Affiliation': 'International Collaborative Donor Project (""Proyecto Colaborativo Internacional Donante""), Murcia, Spain; Transplant Unit, Surgery Service, IMIB - Virgen de la Arrixaca University Clinical Hospital, Murcia, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Ramírez', 'Affiliation': 'International Collaborative Donor Project (""Proyecto Colaborativo Internacional Donante""), Murcia, Spain; Transplant Unit, Surgery Service, IMIB - Virgen de la Arrixaca University Clinical Hospital, Murcia, Spain.'}]",Transplantation proceedings,['10.1016/j.transproceed.2020.02.065']
748,31468177,Use of a curved needle to facilitate lateral sagittal infraclavicular block performance: a randomized clinical trial.,"PURPOSE


Failed needle-tip positioning in an ultrasound-guided infraclavicular block can be due to improper needle insertion point and steep needle insertion angle. Needle pre-curving enables the user to pass the needle with different curved trajectories on approaching the brachial plexus. Aim of the study was to compare curved and non-curved needles as regards the time needed to perform the lateral sagittal infra-clavicular block.
METHODS


Sixty-nine patients undergoing surgery distal to the elbow were randomly allocated to two groups: group A (n = 35), which received ultrasound-guided infraclavicular block using the curved needle; and group B (n = 34), which received the infraclavicular block using the non-curved needle. The primary outcome measure was the time needed to perform the infraclavicular block. Anesthetist's experience with the curved vs. non-curved needle was noted.
RESULTS


Mean (SD) recognition time (120 ± 48 vs. 179 ± 72 s, P = 0.0002) and injection time (54 ± 23 vs. 88 ± 36 s, P = 0.0001) were shorter in group A compared to group B. Median (IQR) procedure pain score was less in group A 2 (1-2) than in group B 2 (2-3); P = 0.001. Median (IQR) satisfaction score was higher with regards to the curved needle 4 (4-5) than non-curved needle 3 (3-4) in performing infraclavicular blockade; P = 0.001.
CONCLUSION


The use of a curved needle reduces the time required to perform the lateral sagittal infraclavicular block. The curved needle provides less procedure pain and higher satisfaction levels among anesthetists than the non-curved needle.
TRIAL REGISTRATION


The trial was registered (04/26/2016) with the ClinicalTrials.gov ID: NCT02799576. Approval Number: #2543. Board Name: Research Ethics Committee. Board Affiliation: Suez Canal University, Faculty of Medicine, Suez Canal University hospital, Ismailia, Egypt, 41522.",2019,"Mean (SD) recognition time (120 ± 48 vs. 179 ± 72 s, P = 0.0002) and injection time (54 ± 23 vs. 88 ± 36 s, P = 0.0001) were shorter in group A compared to group B. Median (IQR) procedure pain score was less in group A 2 (1-2) than in group B 2 (2-3);",['Sixty-nine patients undergoing surgery distal to the elbow'],"['ultrasound-guided infraclavicular block using the curved needle', 'curved needle to facilitate lateral sagittal infraclavicular block performance', 'infraclavicular block using the non-curved needle']","['time needed to perform the infraclavicular block', 'Median (IQR) procedure pain score', 'injection time', 'Median (IQR) satisfaction score', 'Mean (SD) recognition time']","[{'cui': 'C0450388', 'cui_str': '69 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0205129', 'cui_str': 'Sagittal (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}]",69.0,0.0456393,"Mean (SD) recognition time (120 ± 48 vs. 179 ± 72 s, P = 0.0002) and injection time (54 ± 23 vs. 88 ± 36 s, P = 0.0001) were shorter in group A compared to group B. Median (IQR) procedure pain score was less in group A 2 (1-2) than in group B 2 (2-3);","[{'ForeName': 'Tarek F', 'Initials': 'TF', 'LastName': 'Tammam', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Suez Canal University Hospital, Ismailia, Egypt. tarek1367@hotmail.com.'}, {'ForeName': 'Ghada A', 'Initials': 'GA', 'LastName': 'Kamhawy', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Suez Canal University Hospital, Ismailia, Egypt.'}]",Journal of anesthesia,['10.1007/s00540-019-02674-w']
749,32402523,Treatment Adequacy and Adherence as Predictors of Depression Response in Primary Care.,"OBJECTIVE


Primary care is the de facto mental health system in the United States where physicians treat large numbers of depressed older adults with antidepressant medication. This study aimed to examine whether antidepressant dosage adequacy and patient adherence are associated with depression response among middle-aged and older adults prescribed with antidepressants by their primary care provider.
DESIGN


A secondary analysis was conducted on a sample drawn from a randomized controlled trial comparing Treatment as Usual to Treatment Initiation Program, an adherence intervention. Treatment Initiation Program improved adherence but not depression compared to Treatment as Usual (Sirey et al., 2017). For this analysis, we examined dosing adequacy and adherence at 6 and 12 weeks as predictors of depression response in both groups at 12 and 24 weeks.
SETTING


Primary care practices.
PARTICIPANTS


One hundred eighty-seven older adults with depression prescribed an antidepressant for depression by their primary care provider.
MEASUREMENTS


Depression response was defined as 50% reduction on the Hamilton Rating Scale for Depression. Adherence was defined as taking 80% of doses at follow-up interviews (6 and 12 weeks). Patient-reported dosage and duration of antidepressant therapy was collected using the Composite Antidepressant Score (adequacy score of >3) at follow-up.
RESULTS


Greater adherence, but not receipt of adequate dosage, was associated with higher likelihood of treatment response at both 12 (Odds ratio (OR) = 2.63; 95% Confidence Interval (CI), 1.19-5.84) and 24 weeks (OR = 3.09; 95% CI, 1.46-6.55).
CONCLUSION


As physicians prescribe antidepressants to the diverse group of adults seen in primary care, special attention to patients' views and approach to adherence may improve depression outcomes.",2020,"Greater adherence, but not receipt of adequate dosage, was associated with higher likelihood of treatment response at both 12 (Odds ratio (OR) = 2.63; 95% Confidence Interval (CI), 1.19-5.84) and 24 weeks (OR = 3.09; 95% CI, 1.46-6.55).
","['middle-aged and older adults prescribed with antidepressants by their primary care provider', 'One hundred eighty-seven older adults with depression prescribed an antidepressant for depression by their primary care provider', 'depressed older adults with antidepressant medication', 'Primary care practices']",[],"['Greater adherence', 'Depression response', 'Hamilton Rating Scale for Depression', 'depression response', 'Adherence']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517895', 'cui_str': '87'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]",[],"[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}]",187.0,0.0742356,"Greater adherence, but not receipt of adequate dosage, was associated with higher likelihood of treatment response at both 12 (Odds ratio (OR) = 2.63; 95% Confidence Interval (CI), 1.19-5.84) and 24 weeks (OR = 3.09; 95% CI, 1.46-6.55).
","[{'ForeName': 'Jo Anne', 'Initials': 'JA', 'LastName': 'Sirey', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College (JAS, AW, NS, PZ, GA). Electronic address: jsirey@med.cornell.edu.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Woods', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College (JAS, AW, NS, PZ, GA).'}, {'ForeName': 'Nili', 'Initials': 'N', 'LastName': 'Solomonov', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College (JAS, AW, NS, PZ, GA).'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Evans', 'Affiliation': 'Department of Healthcare Policy & Research, Weill Cornell Medicine (LE, SB).'}, {'ForeName': 'Samprit', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Department of Healthcare Policy & Research, Weill Cornell Medicine (LE, SB).'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Zanotti', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College (JAS, AW, NS, PZ, GA).'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Alexopoulos', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College (JAS, AW, NS, PZ, GA).'}, {'ForeName': 'Helen C', 'Initials': 'HC', 'LastName': 'Kales', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of California at Davis (HCK).'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.04.014']
750,32406009,The effect of TJ-28 (Eppikajutsuto) on the prevention of hand-foot syndrome using Capecitabine for colorectal cancer: The Yokohama Clinical Oncology Group Study (YCOG1102).,"BACKGROUND


Eppikajututo (TJ-28, a Kampo medicine) is effective against rheumatoid arthritis and eczema. We conducted a randomized comparative trial to assess the efficacy of TJ-28 for preventing hand-foot syndrome (HFS) as a complication of adjuvant chemotherapy using capecitabine.
METHODS


The present study was a multi-institutional randomized-controlled trial (UMIN000005899). Colorectal cancer patients scheduled to receive capecitabine chemotherapy as adjuvant therapy were randomly assigned to receive TJ-28 (7500 mg/day) or oral pyridoxine (60 mg/day). Patients were monitored for the development of grade ≥ 2 HFS according to the National Cancer Institute Common Toxicity Criteria until chemotherapy completion.
RESULTS


Twenty-two patients were enrolled in this study. The relative dose intensity of capecitabine was 76.2% in the TJ-28 group and 68.2% in the pyridoxine group. Grade ≥ 2 HFS developed in 6 (50.0%) of 12 TJ-28 patients and in 4 (40.0%) of 10 pyridoxine patients. Chemotherapy treatment failure was observed in seven patients, mainly due to HFS, liver dysfunction, diarrhea, and neutropenia. Chemotherapy treatment failure due to HFS occurred in none of the TJ-28 group and 2 patients (20.0%) in the pyridoxine group (p = 0.114).
CONCLUSION


Capecitabine-associated HFS was not markedly prevented by TJ-28 compared with pyridoxine. However, TJ-28 might support the continuation of chemotherapy with capecitabine. Further studies are warranted to clarify the benefits of TJ-28.",2020,The relative dose intensity of capecitabine was 76.2% in the TJ-28 group and 68.2% in the pyridoxine group.,"['colorectal cancer', 'Colorectal cancer patients scheduled to receive', 'Twenty-two patients were enrolled in this study']","['TJ-28 (Eppikajutsuto', 'Capecitabine', 'oral pyridoxine', 'TJ-28', 'capecitabine chemotherapy', 'capecitabine', 'pyridoxine']","['Chemotherapy treatment failure due to HFS', 'HFS, liver dysfunction, diarrhea, and neutropenia', 'Chemotherapy treatment failure', 'Grade ≥', 'HFS']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4549708', 'cui_str': 'eppikajutsuto'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0034272', 'cui_str': 'pyridoxine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0086565', 'cui_str': 'Abnormal liver function'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",22.0,0.103454,The relative dose intensity of capecitabine was 76.2% in the TJ-28 group and 68.2% in the pyridoxine group.,"[{'ForeName': 'Kazuteru', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Department of Gastroenterological Surgery, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Ishibe', 'Affiliation': 'Department of Gastroenterological Surgery, Yokohama City University, Yokohama, Japan. a.ishibe1225@gmail.com.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Watanabe', 'Affiliation': 'Department of Gastroenterological Center, Yokohama City University Medical center, Yokohama, Japan.'}, {'ForeName': 'Mitsuyoshi', 'Initials': 'M', 'LastName': 'Ota', 'Affiliation': 'Department of Gastroenterological Surgery, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Shoichi', 'Initials': 'S', 'LastName': 'Fujii', 'Affiliation': 'Department of Surgery, Koga Hospital, Shizuoka, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Ichikawa', 'Affiliation': 'Department of Oncology, Yokohama City University , Yokohama, Japan.'}, {'ForeName': 'Mari S', 'Initials': 'MS', 'LastName': 'Oba', 'Affiliation': 'Department of Biostatics, Yokohama City University , Yokohama, Japan.'}, {'ForeName': 'Itaru', 'Initials': 'I', 'LastName': 'Endo', 'Affiliation': 'Department of Gastroenterological Surgery, Yokohama City University, Yokohama, Japan.'}]",Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology,['10.1007/s12664-020-01039-6']
751,31432461,"Pharmacokinetics of Total and Unbound Paclitaxel After Administration of Paclitaxel Micellar or Nab-Paclitaxel: An Open, Randomized, Cross-Over, Explorative Study in Breast Cancer Patients.","INTRODUCTION


Paclitaxel micellar is a novel formulation of paclitaxel in which retinoic acid derivates solubilize paclitaxel. The aim of the present study was to compare the unbound and total plasma pharmacokinetics of the new formulation with those of nanoparticle albumin-bound (nab)-paclitaxel and to further assess its safety.
METHODS


In this open, randomized, cross-over study, 28 female patients with breast cancer were given paclitaxel micellar and nab-paclitaxel as a 1-h intravenous infusion at a dose of 260 mg/m 2 . Plasma samples were collected during 10 h, which were projected to cover at least 80% of the area to infinite time, AUC inf . Unbound paclitaxel was measured in ultrafiltrate of plasma. Total paclitaxel in plasma was measured after protein precipitation with acetonitrile. Both assays used ultra-performance liquid chromatography (UPLC) followed by MS/MS for drug quantification. The unbound fraction, fu, was calculated as the ratio between the unbound and the total concentration.
RESULTS


No difference in fu of paclitaxel between the two formulations was observed. Statistical comparison of AUC 0-10h  and C max  of unbound paclitaxel demonstrated that the two formulations met the criteria for bioequivalence. Regarding total paclitaxel levels, C max  but not AUC 0-10h  met the criteria. This study supports a safe administration of paclitaxel micellar.
CONCLUSION


The two formulations, paclitaxel micellar and nab-paclitaxel, behaved similarly following infusion. Probably, both formulations dissociate immediately in the blood, whereupon released paclitaxel rapidly distributes into tissue. Judged from the bioequivalence demonstrated for unbound paclitaxel, the two formulations are considered clinically equivalent.
TRIAL REGISTRATION


EudraCT no.: 2010-019838-27.
FUNDING


Oasmia Pharmaceutical AB.",2019,Statistical comparison of AUC 0-10h  and C max  of unbound paclitaxel demonstrated that the two formulations met the criteria for bioequivalence.,"['Breast Cancer Patients', '28 female patients with breast cancer', ' 2010-019838-27']","['Paclitaxel Micellar or Nab-Paclitaxel', 'ultra-performance liquid chromatography (UPLC', 'nanoparticle albumin-bound (nab)-paclitaxel', 'paclitaxel micellar and nab-paclitaxel', 'paclitaxel', 'EudraCT', 'Unbound paclitaxel', 'Paclitaxel', 'Total and Unbound Paclitaxel']","['fu of paclitaxel', 'Total paclitaxel in plasma', 'ultrafiltrate of plasma', 'Plasma samples']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0008565', 'cui_str': 'Liquid Chromatography'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C1961039', 'cui_str': 'paclitaxel protein-bound'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}]",28.0,0.0276733,Statistical comparison of AUC 0-10h  and C max  of unbound paclitaxel demonstrated that the two formulations met the criteria for bioequivalence.,"[{'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Borgå', 'Affiliation': 'Borgå PK Consulting, Stockholm, Sweden.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Lilienberg', 'Affiliation': 'Oasmia Pharmaceutical AB, Uppsala, Sweden.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Bjermo', 'Affiliation': 'Oasmia Pharmaceutical AB, Uppsala, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Hansson', 'Affiliation': 'CTC Clinical Trial Consultants AB, Uppsala, Sweden.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Heldring', 'Affiliation': 'Oasmia Pharmaceutical AB, Uppsala, Sweden. nina.heldring@oasmia.com.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Dediu', 'Affiliation': 'Arensia Exploratory Medicine in Collaboration with Institutul de Pneumoftiziologie ""Marius Nasta"", Bucharest, Romania.'}]",Advances in therapy,['10.1007/s12325-019-01058-6']
752,31373837,"Effect of OTX-101, a Novel Nanomicellar Formulation of Cyclosporine A, on Conjunctival Staining in Patients with Keratoconjunctivitis Sicca: A Pooled Analysis of Phase 2b/3 and 3 Clinical Trials.","Purpose:  Keratoconjunctivitis sicca (KCS), a multifactorial disease, is the most common ocular condition for patients seeking medical treatment and is characterized by ocular burning, stinging, and dryness. This pooled analysis examined the effect of OTX-101 0.09% versus vehicle on the total and individual conjunctival staining in patients with KCS from phase 2b/3 and phase 3 studies.  Methods:  In these randomized, multicenter, double-masked, and vehicle-controlled studies, patients received 1 drop of OTX-101 0.09% or vehicle in both eyes twice daily. The time points for the pooled analysis were baseline (day 0) and study days 28, 56, and 84/early discontinuation. Conjunctival staining was graded on a 0- to 3-point scale per zone and averaged over both eyes at each assessment. Pooled safety assessments included adverse event (AE) reporting.  Results:  The total mean (standard deviation) conjunctival staining scores at baseline were 5.4 (1.7) for OTX-101 ( n  = 523) and 5.5 (1.7) for vehicle ( n  = 525). OTX-101 versus vehicle significantly reduced the total conjunctival staining scores ( P  = 0.0316, <0.0001, and 0.0002) for days 28, 56, and 84, respectively. The most common treatment-related AE was instillation site pain (21.8% OTX-101 vs. 4.0% vehicle); most AEs were mild in nature.  Conclusions:  Treatment with OTX-101 versus vehicle significantly improved the conjunctival staining in KCS as early as 4 weeks, and the improvement was maintained through 12 weeks. OTX-101 was effective and well tolerated for use in KCS.",2019,"OTX-101 versus vehicle significantly reduced the total conjunctival staining scores ( P  = 0.0316, <0.0001, and 0.0002) for days 28, 56, and 84, respectively.","['Patients with Keratoconjunctivitis Sicca', 'patients with KCS from phase 2b/3 and phase 3 studies']","['OTX-101', 'Cyclosporine']","['instillation site pain', 'total mean', 'Conjunctival staining', 'total conjunctival staining scores', 'adverse event (AE) reporting', 'conjunctival staining', 'effective and well tolerated']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022575', 'cui_str': 'Keratoconjunctivitis Sicca'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0010594', 'cui_str': 'Cyclosporins'}]","[{'cui': 'C0858797', 'cui_str': 'Instillation site pain'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3203718', 'cui_str': 'Conjunctival staining'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}]",525.0,0.228291,"OTX-101 versus vehicle significantly reduced the total conjunctival staining scores ( P  = 0.0316, <0.0001, and 0.0002) for days 28, 56, and 84, respectively.","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Smyth-Medina', 'Affiliation': 'North Valley Eye Medical Group, Inc., Mission Hills, California.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Johnston', 'Affiliation': 'Georgia Eye Partners, Atlanta, Georgia.'}, {'ForeName': 'Douglas K', 'Initials': 'DK', 'LastName': 'Devries', 'Affiliation': 'Eye Care Associates of Nevada, Sparks, Nevada.'}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Jasper', 'Affiliation': 'Advanced Eyecare Specialists, West Palm Beach, Florida.'}, {'ForeName': 'Shane R', 'Initials': 'SR', 'LastName': 'Kannarr', 'Affiliation': 'Kannarr Eye Care, Pittsburg, Kansas.'}, {'ForeName': 'Barry A', 'Initials': 'BA', 'LastName': 'Schechter', 'Affiliation': 'Florida Eye Microsurgical Institute, Inc., Boynton Beach, Florida.'}, {'ForeName': 'Bridgitte', 'Initials': 'B', 'LastName': 'Shen Lee', 'Affiliation': 'Vision Optique, Houston, Texas.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Varghese', 'Affiliation': 'Sun Pharmaceutical Industries, Inc., Princeton, New Jersey.'}, {'ForeName': 'Abayomi', 'Initials': 'A', 'LastName': 'Ogundele', 'Affiliation': 'Sun Pharmaceutical Industries, Inc., Princeton, New Jersey.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Darby', 'Affiliation': 'Sun Pharma Advanced Research Company, Ltd., Princeton, New Jersey.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Karpecki', 'Affiliation': 'Kentucky Eye Institute, Lexington, Kentucky.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Luchs', 'Affiliation': 'Hofstra Northwell School of Medicine, Hempstead, New York.'}]",Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics,['10.1089/jop.2018.0154']
753,31553639,Treatment of Childhood Nasopharyngeal Carcinoma With Induction Chemotherapy and Concurrent Chemoradiotherapy: Results of the Children's Oncology Group ARAR0331 Study.,"PURPOSE


The treatment of childhood nasopharyngeal carcinoma has been adapted from adult regimens; pediatric-specific studies are limited. The ARAR0331 study sought to evaluate the impact of induction chemotherapy (IC) and concurrent chemoradiotherapy (CCR).
PATIENTS AND METHODS


Patients with American Joint Committee on Cancer stages IIb to IV were scheduled to receive three cycles of IC with cisplatin and fluorouracil, followed by CCR with three cycles of cisplatin. Patients with complete or partial response to IC received 61.2 Gy to the nasopharynx and neck, and patients with stable disease received 71.2 Gy.
RESULTS


Between February 2006 and January 2012, 111 patients (75 male) were enrolled. Median age was 15 years, and 46.8% of the patients were African American. After a feasibility analysis, the study was amended to reduce cisplatin to two cycles during CCR. The 5-year event-free survival (EFS) and overall survival estimates were 84.3% and 89.2%, respectively. The 5-year EFS for stages IIb, III, and IV were 100%, 82.8%, and 82.7%, respectively. The 5-year cumulative incidence estimates of local, distant, and combined relapse were 3.7%, 8.7%, and 1.8%, respectively. Patients treated with three versus two CCR cycles of cisplatin had improved 5-year postinduction EFS (90.7%  v  81.2%,  P  = .14).
CONCLUSION


Patients in ARAR0331 were characterized by advanced disease and by a high proportion of black children and adolescents. Treatment with IC and CRT resulted in excellent outcomes. A radiation dose reduction is possible for patients responding to IC. Although the outcomes are comparable, we observed a trend toward decreased EFS for patients assigned to receive fewer doses of cisplatin during CCR.",2019,"The 5-year event-free survival (EFS) and overall survival estimates were 84.3% and 89.2%, respectively.","['Childhood Nasopharyngeal Carcinoma', 'Between February 2006 and January 2012, 111 patients (75 male) were enrolled', 'Median age was 15 years, and 46.8% of the patients were African American', 'Patients with American Joint Committee on Cancer stages IIb to IV']","['IC with cisplatin and fluorouracil, followed by CCR with three cycles of cisplatin', 'induction chemotherapy (IC) and concurrent chemoradiotherapy (CCR', 'Induction Chemotherapy and Concurrent Chemoradiotherapy', 'cisplatin', 'IC and CRT']","['5-year cumulative incidence estimates of local, distant, and combined relapse', '5-year event-free survival (EFS) and overall survival estimates', '5-year EFS', '5-year postinduction EFS']","[{'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma (disorder)'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0441769', 'cui_str': 'Stage 2B (qualifier value)'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",111.0,0.110512,"The 5-year event-free survival (EFS) and overall survival estimates were 84.3% and 89.2%, respectively.","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Rodriguez-Galindo', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Krailo', 'Affiliation': ""Children's Oncology Group, Monrovia, CA.""}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Krasin', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ""Children's Oncology Group, Monrovia, CA.""}, {'ForeName': 'M Beth', 'Initials': 'MB', 'LastName': 'McCarville', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hicks', 'Affiliation': ""Texas Children's Hospital, Houston, TX.""}, {'ForeName': 'Farzana', 'Initials': 'F', 'LastName': 'Pashankar', 'Affiliation': 'Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Alberto S', 'Initials': 'AS', 'LastName': 'Pappo', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01276']
754,32212395,Optimizing Retention in a Pragmatic Trial of Community-Living Older Persons: The STRIDE Study.,"OBJECTIVES


The Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) study is testing the effectiveness of a multifactorial intervention to prevent serious fall injuries. Our aim was to describe procedures that were implemented to optimize participant retention; report retention yields by age, sex, clinical site, and follow-up time; provide reasons for study withdrawals; and highlight the successes and lessons learned from the STRIDE retention efforts.
DESIGN


Pragmatic cluster randomized trial.
SETTING


A total of 86 primary care practices within 10 US healthcare systems.
PARTICIPANTS


A total of 5451 community-living persons, 70 years of age or older, at high risk for serious fall injuries.
MEASUREMENTS


Study outcomes were collected every 4 months by a central call center. Reconsent was required to extend follow-up beyond the originally planned 36 months.
RESULTS


Over a median follow-up of 3.2 years (interquartile range = 2.8-3.7 y), 439 (8.1%) participants died and 600 (11.0%) withdrew their consent or did not reconsent to extend follow-up beyond 36 months, yielding rates (per 100 person-years) of deaths and withdrawals of 2.6 and 3.6, respectively. The withdrawal rate increased with advancing age, was comparable for men and women, and did not differ much by clinical site. The most common reasons for withdrawal were illness and unable to contact for reconsent at 36 months. Completion of the follow-up interviews was greater than 93% at each time point. Most participants completed all (71.8%) or all but one (9.2%) of the follow-up interviews. The most common reason for not completing a follow-up interview was unable to contact, with rates ranging from 2.8% at 40 months to 4.6% at 20 months.
CONCLUSION


Completion of the thrice-yearly follow-up interviews in STRIDE was high, and retention of participants over 44 months exceeded the original projections. The procedures used in STRIDE, together with lessons learned, should assist other investigators who are planning or conducting large pragmatic trials of vulnerable older persons. J Am Geriatr Soc 68:1242-1249, 2020.",2020,"The withdrawal rate increased with advancing age, was comparable for men and women, and did not differ much by clinical site.","['A total of 86 primary care practices within 10 US healthcare systems', 'Community-Living Older Persons', 'A total of 5451 community-living persons, 70\u2009years of age or older, at high risk for serious fall injuries', 'vulnerable older persons']",['multifactorial intervention'],['withdrawal rate'],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1301836', 'cui_str': 'Falling injury (disorder)'}]",[],[],5451.0,0.0806889,"The withdrawal rate increased with advancing age, was comparable for men and women, and did not differ much by clinical site.","[{'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Gill', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'McGloin', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Shelton', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Luann M', 'Initials': 'LM', 'LastName': 'Bianco', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Eleni A', 'Initials': 'EA', 'LastName': 'Skokos', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Nancy K', 'Initials': 'NK', 'LastName': 'Latham', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Ganz', 'Affiliation': 'Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Linda V', 'Initials': 'LV', 'LastName': 'Nyquist', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Wallace', 'Affiliation': 'University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Martha B', 'Initials': 'MB', 'LastName': 'Carnie', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Patricia C', 'Initials': 'PC', 'LastName': 'Dykes', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Lori A', 'Initials': 'LA', 'LastName': 'Goehring', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Doyle', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Charpentier', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Erich J', 'Initials': 'EJ', 'LastName': 'Greene', 'Affiliation': 'Yale Center for Analytical Sciences, Yale School of Public Health, New Haven, Connecticut.'}, {'ForeName': 'Katy L', 'Initials': 'KL', 'LastName': 'Araujo', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16356']
755,31543516,"Calcium: magnesium intake ratio and colorectal carcinogenesis, results from the prostate, lung, colorectal, and ovarian cancer screening trial.","BACKGROUND


We aimed to evaluate the associations between calcium and various stages of colorectal carcinogenesis and whether these associations are modified by the calcium to magnesium (Ca:Mg) ratio.
METHODS


We tested our hypotheses in the prostate lung, colorectal and ovarian cancer screening trial.
RESULTS


Calcium intake did not show a dose-response association with incident adenoma of any size/stage (P- trend  = 0.17), but followed an inverse trend when restricted to synchronous/advanced adenoma cases (P- trend  = 0.05). This inverse trend was mainly in participants with Ca:Mg ratios between 1.7 and 2.5 (P- trend  = 0.05). No significant associations were observed for metachronous adenoma. Calcium intake was inversely associated with CRC (P- trend  = 0.03); the association was primarily present for distal CRC (P- trend  = 0.01). The inverse association between calcium and distal CRC was further modified by the Ca:Mg ratio (P- interaction  < 0.01); significant dose-response associations were found only in participants with a Ca:Mg ratio between 1.7 and 2.5 (P- trend  = 0.04). No associations for calcium were found in the Ca:Mg ratio above 2.5 or below 1.7.
CONCLUSION


Higher calcium intake may be related to reduced risks of incident advanced and/or synchronous adenoma and incident distal CRC among subjects with Ca:Mg intake ratios between 1.7 and 2.5.",2019,"RESULTS


Calcium intake did not show a dose-response association with incident adenoma of any size/stage (P- trend  = 0.17), but followed an inverse trend when restricted to synchronous/advanced adenoma cases (P- trend  = 0.05).","['subjects with Ca', 'participants with Ca']",['Calcium: magnesium'],"['Calcium intake', 'Mg intake ratios', 'metachronous adenoma']",[],"[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}]","[{'cui': 'C0489458', 'cui_str': 'Calcium intake (observable entity)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}]",,0.0314611,"RESULTS


Calcium intake did not show a dose-response association with incident adenoma of any size/stage (P- trend  = 0.17), but followed an inverse trend when restricted to synchronous/advanced adenoma cases (P- trend  = 0.05).","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Division of Epidemiology, Vanderbilt Ingram Cancer Center, Department of Medicine, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Ayush', 'Initials': 'A', 'LastName': 'Giri', 'Affiliation': 'Division of Epidemiology, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Xiangzhu', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Division of Epidemiology, Vanderbilt Ingram Cancer Center, Department of Medicine, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Martha J', 'Initials': 'MJ', 'LastName': 'Shrubsole', 'Affiliation': 'Division of Epidemiology, Vanderbilt Ingram Cancer Center, Department of Medicine, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Yixing', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Medicine, Marlene and Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'Xingyi', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Division of Epidemiology, Vanderbilt Ingram Cancer Center, Department of Medicine, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Reid', 'Initials': 'R', 'LastName': 'Ness', 'Affiliation': 'Department of Medicine, Vanderbilt Center for Human Nutrition, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Seidner', 'Affiliation': 'Department of Medicine, Vanderbilt Center for Human Nutrition, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Giovannucci', 'Affiliation': 'Departments of Nutrition and Epidemiology, Harvard School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Todd L', 'Initials': 'TL', 'LastName': 'Edwards', 'Affiliation': 'Division of Epidemiology, Vanderbilt Ingram Cancer Center, Department of Medicine, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Dai', 'Affiliation': 'Division of Epidemiology, Vanderbilt Ingram Cancer Center, Department of Medicine, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA. qi.dai@vanderbilt.edu.'}]",British journal of cancer,['10.1038/s41416-019-0579-2']
756,30861098,Association between body mass index and response to duloxetine for aromatase inhibitor-associated musculoskeletal symptoms in SWOG S1202.,"BACKGROUND


Aromatase inhibitor (AI)-associated musculoskeletal symptoms (AIMSS) negatively impact adherence to and persistence with therapy. In SWOG S1202, patients with AIMSS who were treated with duloxetine, a serotonin norepinephrine reuptake inhibitor, reported improvement in pain by 12 weeks compared with placebo. Based on the authors' prior observation that responses to pain interventions differ between obese and nonobese patients, the current study examined whether response to duloxetine therapy differed by obesity status.
METHODS


In SWOG S1202, a total of 299 AI-treated postmenopausal women with stage I to III (AJCC 7th Edition) breast cancer who developed new or worsening average pain were enrolled, randomized to duloxetine or placebo, and treated for 12 weeks. Patient-reported outcomes were obtained at baseline and through 12 weeks. Patients were categorized into nonobese (body mass index [BMI] <30 kg/m 2  ) or obese (BMI ≥30 kg/m 2  ). The authors tested the interaction between intervention and obesity with respect to average pain at 12 weeks in the 289 eligible patients, using a P value of .05 to indicate statistical significance.
RESULTS


In approximately 54% of evaluable patients with a BMI ≥30 kg/m 2  , the reduction in the mean average pain score between baseline and 12 weeks was statistically significantly greater for patients treated with duloxetine compared with those receiving placebo (-2.73 vs -1.64 points; P = .003). Conversely, in the nonobese patients, the reduction in the mean average pain score was similar in the 2 cohorts (-2.46 vs -2.34 points; P = .75). The P value for interaction was .02, thereby meeting the threshold criteria of the current study. Similar findings were evident for other pain-related patient-reported outcomes.
CONCLUSIONS


In this trial, obese patients with AIMSS obtained more analgesic benefit from duloxetine compared with nonobese patients. Additional studies are warranted to determine the biologic basis for these findings.",2019,"Conversely, in the nonobese patients, the reduction in the mean average pain score was similar in the 2 cohorts (-2.46 vs -2.34 points; P = .75).","['AJCC 7th Edition) breast cancer who developed new or worsening average pain', 'Patients were categorized into nonobese (body mass index [BMI] <30\xa0kg/m 2  ) or obese (BMI ≥30\xa0kg/m 2  ', 'obese and nonobese patients', 'obese patients with AIMSS', '299 AI-treated postmenopausal women with stage I to III']","['placebo', 'duloxetine or placebo', 'duloxetine']","['average pain', 'analgesic benefit', 'pain', 'mean average pain score']","[{'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0245561', 'cui_str': 'duloxetine'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",299.0,0.281789,"Conversely, in the nonobese patients, the reduction in the mean average pain score was similar in the 2 cohorts (-2.46 vs -2.34 points; P = .75).","[{'ForeName': 'N Lynn', 'Initials': 'NL', 'LastName': 'Henry', 'Affiliation': 'Department of Internal Medicine, University of Utah Huntsman Cancer Institute, Salt Lake City, Utah.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Unger', 'Affiliation': 'SWOG Statistics and Data Management Center, Seattle, Washington.'}, {'ForeName': 'Cathee', 'Initials': 'C', 'LastName': 'Till', 'Affiliation': 'SWOG Statistics and Data Management Center, Seattle, Washington.'}, {'ForeName': 'Anne F', 'Initials': 'AF', 'LastName': 'Schott', 'Affiliation': 'Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Katherine D', 'Initials': 'KD', 'LastName': 'Crew', 'Affiliation': 'Department of Medicine, Columbia University, New York, New York.'}, {'ForeName': 'Danika L', 'Initials': 'DL', 'LastName': 'Lew', 'Affiliation': 'SWOG Statistics and Data Management Center, Seattle, Washington.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Fisch', 'Affiliation': 'AIM Specialty Health, Chicago, Illinois.'}, {'ForeName': 'Carol M', 'Initials': 'CM', 'LastName': 'Moinpour', 'Affiliation': 'Cancer Prevention Program, Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Wade', 'Affiliation': 'Heartland National Cancer Institute Community Oncology Research Program, Decatur, Illinois.'}, {'ForeName': 'Dawn L', 'Initials': 'DL', 'LastName': 'Hershman', 'Affiliation': 'Department of Medicine, Columbia University, New York, New York.'}]",Cancer,['10.1002/cncr.32024']
757,32402585,Body weight of individuals with obesity decreases after a 6-month high pasta or low pasta Mediterranean diet weight-loss intervention.,"BACKGROUND & AIMS


The effect of pasta consumption within a low-energy Mediterranean diet on body weight regulation has been scarcely explored. This paper investigates the effect of two Mediterranean diets, which differed for lower or higher pasta intake, on body weight change in individuals with obesity.
METHODS & RESULTS


Forty-nine volunteers finished a quasi-experimental 6-month two-parallel group dietary intervention. Participants were assigned to a low-energy high pasta (HP) or to a low-energy low Pasta (LP) group on the basis of their pasta intake (HP ≥ 5 or LP ≤ 3 times/week). Anthropometrics, blood pressure and heart rate were measured every month. Weight maintenance was checked at month 12. Body composition (bioelectrical impedance analysis, BIA), food intake (24-h recall plus a 7-day carbohydrate record) and the perceived quality of life (36-item short-form health survey, SF-36) were assessed at baseline, 3 and 6 months. Blood samples were collected at baseline and month 6 to assess glucose and lipid metabolism. After 6-month intervention, body weight reduction was -10 ± 8% and -7 ± 4% in HP and LP diet, respectively, and it remained similar at month 12. Both dietary interventions improved anthropometric parameters, body composition, glucose and lipid metabolism, but no significant differences were observed between treatment groups. No differences were observed for blood pressure and heart rate between treatments and among times. HP diet significantly improved perception of quality of life for the physical component.
CONCLUSIONS


Independent of pasta consumption frequency, low-energy Mediterranean diets were successful in improving anthropometrics, physiological parameters and dietary habits after a 6-month weight-loss intervention. This trial was registered at clinicaltrials.gov as NCT03341650.",2020,"Both dietary interventions improved anthropometric parameters, body composition, glucose and lipid metabolism, but no significant differences were observed between treatment groups.","['Forty-nine volunteers finished a quasi-experimental 6-month two-parallel group dietary intervention', 'individuals with obesity decreases after a 6-month high pasta or low pasta Mediterranean diet weight-loss intervention', 'individuals with obesity']","['low-energy high pasta (HP) or to a low-energy low Pasta (LP', 'HP diet', 'Mediterranean diets']","['perception of quality of life', 'Weight maintenance', 'blood pressure and heart rate', 'anthropometrics, physiological parameters and dietary habits', 'glucose and lipid metabolism', 'Blood samples', 'Body weight', 'anthropometric parameters, body composition, glucose and lipid metabolism', 'Anthropometrics, blood pressure and heart rate', 'Body composition (bioelectrical impedance analysis, BIA), food intake (24-h recall plus a 7-day carbohydrate record) and the perceived quality of life (36-item short-form health survey, SF-36', 'body weight reduction']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0452694', 'cui_str': 'Pasta'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0452694', 'cui_str': 'Pasta'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0162536', 'cui_str': 'Biolectric Impedance'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",49.0,0.0258637,"Both dietary interventions improved anthropometric parameters, body composition, glucose and lipid metabolism, but no significant differences were observed between treatment groups.","[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Rosi', 'Affiliation': 'Department of Food & Drugs, University of Parma, Parma, Italy.'}, {'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Tesan', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Annalaura', 'Initials': 'A', 'LastName': 'Cremonini', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Biasini', 'Affiliation': 'Department of Food & Drugs, University of Parma, Parma, Italy.'}, {'ForeName': 'Lorenza', 'Initials': 'L', 'LastName': 'Bicchieri', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Cossu', 'Affiliation': 'Department of Food & Drugs, University of Parma, Parma, Italy.'}, {'ForeName': 'Furio', 'Initials': 'F', 'LastName': 'Brighenti', 'Affiliation': 'Department of Food & Drugs, University of Parma, Parma, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': ""Dall'Aglio"", 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Scazzina', 'Affiliation': 'Department of Food & Drugs, University of Parma, Parma, Italy. Electronic address: francesca.scazzina@unipr.it.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.02.013']
758,32404723,The Effect of Self-Care Program Based on Modeling and Role Modeling Theory on Body Image Nurturance in Patients With Colorectal Cancer: A Randomized Clinical Trial.,"One of the most critical disorders among patients with colorectal cancer is a change in their body image. This study aimed to examine the effect of a self-care program based on the modeling and role-modeling theory on nurturing body image of patients with colorectal cancer. In 2018, a 2-group randomized clinical trial was conducted in Mashhad, Iran. According to the modeling and role-modeling theory, 27 patients allocated in the experimental group received five 30- to 45-minute sessions at the hospital and 4 sessions of phone counseling within 2 weeks. Twenty-seven patients randomly allocated in the control group received the routine care. Data were collected by demographic and body image scales 3 times with the patients. The mean age of the patients in experimental and control groups was not significantly different (P = .46). The mean scores of the body image at the admission time were 26.8 ± 2.6 in the experimental and 27.9 ± 3.1 in control groups (P = .12). However, the mean scores of body image of the experimental group were 24.3 ± 4.6 at the discharge time and 28.1 ± 2.1 during the follow-up phase. In the control group, the body image scores were 21.0 ± 5.6 at discharge time and 22.9 ± 6.1 during the follow-up phase. Repeated-measures analysis of variance revealed significant differences between the 2 groups (P ≤ .001). Application of the self-care program based on the modeling and role-modeling theory can play a critical role in nurturing the body image of patients with colorectal cancer.",2020,The mean age of the patients in experimental and control groups was not significantly different (P = .46).,"['Patients With Colorectal Cancer', 'patients with colorectal cancer']","['routine care', 'Self-Care Program', 'self-care program']","['mean scores of the body image at the admission time', 'mean scores of body image', 'body image scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",27.0,0.0185153,The mean age of the patients in experimental and control groups was not significantly different (P = .46).,"[{'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Pakzad Khalilabad', 'Affiliation': 'Nursing and Midwifery Care Research Center, Mashhad University of Medical Sciences, Mashhahd, Iran (Ms Pakzad Khalilabad, Dr Aghebati, and Mr Behnam Vashani); and Department of Medical Surgical Nursing (Ms Pakzad Khalilabad and Dr Aghebati), and Pediatric Nursing (Mr Behnam Vashani), School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Aghebati', 'Affiliation': ''}, {'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Behnam Vashani', 'Affiliation': ''}]",Holistic nursing practice,['10.1097/HNP.0000000000000390']
759,32404725,Effects of the Continuous Care Model on the Health-Promoting Lifestyle in Breast Cancer Survivors: A Randomized Clinical Trial.,"Breast cancer is the most frequently diagnosed cancer and the chief cause of cancer-related death among women worldwide, with the incidence increasing exponentially particularly in low- to middle-income countries. The increase in the incidence of breast cancer is partly accounted for by increases in life expectancy due to improvements in public health, but also related to an increase in risk factors for cancer including smoking, excess body weight, decreased physical activity, and changes in reproductive activity. Health-promoting lifestyle is therefore one of the major topics of importance in studying chronic illnesses and cancer. Health promotion interventions, including the use of care models, have a vast contribution to make in terms of timely diagnosis and improved survival. One such care model, which has been designed to increase self-care, adherence, and performance in chronic patients, is the continuous care model (CCM). This study was conducted with the purpose of determining the influence of the CCM on the health-promoting lifestyle of patients with breast cancer during 2017-2018. In this randomized clinical trial, 60 patients with breast cancer were chosen by convenience sampling followed by random allocation into treatment and control groups. Six sessions of group discussion were held for the treatment group according to the CCM and items in the health-promoting lifestyle questionnaire. Data collection tools included a general health questionnaire, a demographic questionnaire, a family support questionnaire, and the Health Promoting Lifestyle Profile (HPLP), which respondents completed before and after the intervention. P values ≤ .05 were considered significant. When comparing the mean score of health-promoting lifestyle in both the control and treatment groups, before and after the intervention, significant increases in every dimension were observed. The average overall health promotion lifestyle was revealed to be significantly elevated from 123.48 to 147.12. However, in the control group the mean scores had slightly increased or were the same in all the dimensions. In addition, the average overall health promotion lifestyle had increased from 119.89 to 121.32. The observed difference in mean scores was not statistically significant. The CCM increased the score of health-promoting lifestyle of patients with breast cancer. Therefore, this caring model can be considered an alternative to improve healthy lifestyles of patients with cancer.",2020,"The increase in the incidence of breast cancer is partly accounted for by increases in life expectancy due to improvements in public health, but also related to an increase in risk factors for cancer including smoking, excess body weight, decreased physical activity, and changes in reproductive activity.","['patients with breast cancer during 2017-2018', 'patients with cancer', 'Breast Cancer Survivors', '60 patients with breast cancer', 'patients with breast cancer']","['Continuous Care Model', 'CCM']","['mean scores', 'score of health-promoting lifestyle', 'average overall health promotion lifestyle', 'every dimension', 'mean score of health-promoting lifestyle']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0065772', 'cui_str': 'MCC protocol'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",60.0,0.0150827,"The increase in the incidence of breast cancer is partly accounted for by increases in life expectancy due to improvements in public health, but also related to an increase in risk factors for cancer including smoking, excess body weight, decreased physical activity, and changes in reproductive activity.","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Moghaddam Tabrizi', 'Affiliation': 'Nursing and Midwifery School, Reproductive Health Research Center, Urmia University of Medical Sciences, Urmia, Iran (Dr Moghaddam Tabrizi) and Nursing and Midwifery School, Urmia University of Medical Sciences, Urmia, Iran (Ms Rajabzadeh and Dr Eghtedar).'}, {'ForeName': 'Hanieh', 'Initials': 'H', 'LastName': 'Rajabzadeh', 'Affiliation': ''}, {'ForeName': 'Samereh', 'Initials': 'S', 'LastName': 'Eghtedar', 'Affiliation': ''}]",Holistic nursing practice,['10.1097/HNP.0000000000000392']
760,32401715,"Triple combination of interferon beta-1b, lopinavir-ritonavir, and ribavirin in the treatment of patients admitted to hospital with COVID-19: an open-label, randomised, phase 2 trial.","BACKGROUND


Effective antiviral therapy is important for tackling the coronavirus disease 2019 (COVID-19) pandemic. We assessed the efficacy and safety of combined interferon beta-1b, lopinavir-ritonavir, and ribavirin for treating patients with COVID-19.
METHODS


This was a multicentre, prospective, open-label, randomised, phase 2 trial in adults with COVID-19 who were admitted to six hospitals in Hong Kong. Patients were randomly assigned (2:1) to a 14-day combination of lopinavir 400 mg and ritonavir 100 mg every 12 h, ribavirin 400 mg every 12 h, and three doses of 8 million international units of interferon beta-1b on alternate days (combination group) or to 14 days of lopinavir 400 mg and ritonavir 100 mg every 12 h (control group). The primary endpoint was the time to providing a nasopharyngeal swab negative for severe acute respiratory syndrome coronavirus 2 RT-PCR, and was done in the intention-to-treat population. The study is registered with ClinicalTrials.gov, NCT04276688.
FINDINGS


Between Feb 10 and March 20, 2020, 127 patients were recruited; 86 were randomly assigned to the combination group and 41 were assigned to the control group. The median number of days from symptom onset to start of study treatment was 5 days (IQR 3-7). The combination group had a significantly shorter median time from start of study treatment to negative nasopharyngeal swab (7 days [IQR 5-11]) than the control group (12 days [8-15]; hazard ratio 4·37 [95% CI 1·86-10·24], p=0·0010). Adverse events included self-limited nausea and diarrhoea with no difference between the two groups. One patient in the control group discontinued lopinavir-ritonavir because of biochemical hepatitis. No patients died during the study.
INTERPRETATION


Early triple antiviral therapy was safe and superior to lopinavir-ritonavir alone in alleviating symptoms and shortening the duration of viral shedding and hospital stay in patients with mild to moderate COVID-19. Future clinical study of a double antiviral therapy with interferon beta-1b as a backbone is warranted.
FUNDING


The Shaw-Foundation, Richard and Carol Yu, May Tam Mak Mei Yin, and Sanming Project of Medicine.",2020,Adverse events included self-limited nausea and diarrhoea with no difference between the two groups.,"['patients with COVID-19', '127 patients were recruited; 86', 'adults with COVID-19 who were admitted to six hospitals in Hong Kong', 'Between Feb 10 and March 20, 2020', 'patients admitted to hospital with COVID-19', 'patients with mild to moderate COVID-19']","['lopinavir-ritonavir alone', 'lopinavir 400 mg and ritonavir', 'interferon beta-1b, lopinavir-ritonavir, and ribavirin', 'combined interferon beta-1b, lopinavir-ritonavir, and ribavirin', 'lopinavir 400 mg and ritonavir 100 mg every 12 h, ribavirin', 'lopinavir-ritonavir']","['self-limited nausea and diarrhoea', 'shorter median time', 'efficacy and safety', 'time to providing a nasopharyngeal swab negative for severe acute respiratory syndrome coronavirus 2 RT-PCR, and was done in the intention-to-treat population', 'duration of viral shedding and hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0244713', 'cui_str': 'interferon beta-1b'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0992889', 'cui_str': 'Ritonavir 100 MG'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0162633', 'cui_str': 'Viral Shedding'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",127.0,0.118203,Adverse events included self-limited nausea and diarrhoea with no difference between the two groups.,"[{'ForeName': 'Ivan Fan-Ngai', 'Initials': 'IF', 'LastName': 'Hung', 'Affiliation': 'Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China; State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Kwok-Cheung', 'Initials': 'KC', 'LastName': 'Lung', 'Affiliation': 'Department of Medicine, Pamela Youde Nethersole Eastern Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Eugene Yuk-Keung', 'Initials': 'EY', 'LastName': 'Tso', 'Affiliation': 'Department of Medicine, United Christian Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine and Geriatrics, Ruttonjee Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Tom Wai-Hin', 'Initials': 'TW', 'LastName': 'Chung', 'Affiliation': 'Department of Microbiology, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Man-Yee', 'Initials': 'MY', 'LastName': 'Chu', 'Affiliation': 'Department of Medicine, Queen Elizabeth Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Yuk-Yung', 'Initials': 'YY', 'LastName': 'Ng', 'Affiliation': 'Department of Medicine, Tuen Mun Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Lo', 'Affiliation': 'Department of Medicine and Geriatrics, Ruttonjee Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Jacky', 'Initials': 'J', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine, Princess Margaret Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Anthony Raymond', 'Initials': 'AR', 'LastName': 'Tam', 'Affiliation': 'Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Hoi-Ping', 'Initials': 'HP', 'LastName': 'Shum', 'Affiliation': 'Department of Intensive Care, Pamela Youde Nethersole Eastern Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine, United Christian Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Alan Ka-Lun', 'Initials': 'AK', 'LastName': 'Wu', 'Affiliation': 'Department of Microbiology, Pamela Youde Nethersole Eastern Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Kit-Man', 'Initials': 'KM', 'LastName': 'Sin', 'Affiliation': 'Department of Medicine, Tuen Mun Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Wai-Shing', 'Initials': 'WS', 'LastName': 'Leung', 'Affiliation': 'Department of Medicine, Princess Margaret Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Wai-Lam', 'Initials': 'WL', 'LastName': 'Law', 'Affiliation': 'Department of Medicine, Queen Elizabeth Hospital, Hong Kong SAR, China.'}, {'ForeName': 'David Christopher', 'Initials': 'DC', 'LastName': 'Lung', 'Affiliation': 'Department of Microbiology, Queen Elizabeth Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Sin', 'Affiliation': 'Department of Intensive Care, Queen Mary Hospital, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Yeung', 'Affiliation': 'Department of Intensive Care, Queen Mary Hospital, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Cyril Chik-Yan', 'Initials': 'CC', 'LastName': 'Yip', 'Affiliation': 'Department of Microbiology, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Ricky Ruiqi', 'Initials': 'RR', 'LastName': 'Zhang', 'Affiliation': 'Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China; State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Agnes Yim-Fong', 'Initials': 'AY', 'LastName': 'Fung', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Erica Yuen-Wing', 'Initials': 'EY', 'LastName': 'Yan', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Kit-Hang', 'Initials': 'KH', 'LastName': 'Leung', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Jonathan Daniel', 'Initials': 'JD', 'LastName': 'Ip', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Allen Wing-Ho', 'Initials': 'AW', 'LastName': 'Chu', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Wan-Mui', 'Initials': 'WM', 'LastName': 'Chan', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Anthony Chin-Ki', 'Initials': 'AC', 'LastName': 'Ng', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Rodney', 'Initials': 'R', 'LastName': 'Lee', 'Affiliation': 'Department of Microbiology, Pamela Youde Nethersole Eastern Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Kitty', 'Initials': 'K', 'LastName': 'Fung', 'Affiliation': 'Department of Microbiology, United Christian Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Alwin', 'Initials': 'A', 'LastName': 'Yeung', 'Affiliation': 'Department of Medicine and Geriatrics, Ruttonjee Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Tak-Chiu', 'Initials': 'TC', 'LastName': 'Wu', 'Affiliation': 'Department of Medicine, Queen Elizabeth Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Johnny Wai-Man', 'Initials': 'JW', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine, Queen Elizabeth Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Wing-Wah', 'Initials': 'WW', 'LastName': 'Yan', 'Affiliation': 'Department of Intensive Care, Pamela Youde Nethersole Eastern Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Wai-Ming', 'Initials': 'WM', 'LastName': 'Chan', 'Affiliation': 'Department of Intensive Care, Queen Mary Hospital, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Jasper Fuk-Woo', 'Initials': 'JF', 'LastName': 'Chan', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Albert Kwok-Wai', 'Initials': 'AK', 'LastName': 'Lie', 'Affiliation': 'Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Owen Tak-Yin', 'Initials': 'OT', 'LastName': 'Tsang', 'Affiliation': 'Department of Medicine, Princess Margaret Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Vincent Chi-Chung', 'Initials': 'VC', 'LastName': 'Cheng', 'Affiliation': 'Department of Microbiology, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Tak-Lun', 'Initials': 'TL', 'LastName': 'Que', 'Affiliation': 'Department of Microbiology, Tuen Mun Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Chak-Sing', 'Initials': 'CS', 'LastName': 'Lau', 'Affiliation': 'Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Kwok-Hung', 'Initials': 'KH', 'LastName': 'Chan', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Kelvin Kai-Wang', 'Initials': 'KK', 'LastName': 'To', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Kwok-Yung', 'Initials': 'KY', 'LastName': 'Yuen', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China. Electronic address: kyyuen@hku.hk.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31042-4']
761,32401905,Prevention of alcohol consumption and transmission of human immunodeficiency virus: randomized clinical trial.,"OBJECTIVE


to know the effects of a nursing intervention to reduce alcohol use and risk factors for transmission of human immunodeficiency virus (HIV).
METHOD


randomized single-blinded clinical trial performed by nurses with young women. The study included 66 participants in the intervention group and 66 participants in the control group. The instruments were the Alcohol Use Disorders Identification Test, the HIV Risk Behavior Knowledge and the Condom Use Self-efficacy Scale. Analysis of variance was used.
RESULTS


alcohol involvement decreased in the intervention group (F (1.119) = 50.28; p < 0.001; η2p = 0.297), while HIV knowledge (F (1.130) = 34.34; p < 0.001; η2p = 0.209) and condom use self-efficacy increased (F (1.129) = 27.20; p < 0.001; η2p = 0.174). In addition, less participants consumed alcohol in the past week compared to the control group (χ2 = 15.95; p < 0.001).
CONCLUSION


the nursing intervention had positive effects, which could help young women stay away from alcohol use and the risk of sexually transmitted infections. NCT: 02405481.",2020,"The instruments were the Alcohol Use Disorders Identification Test, the HIV Risk Behavior Knowledge and the Condom Use Self-efficacy Scale.","['human immunodeficiency virus', '66 participants in the intervention group and 66 participants in the control group', 'nurses with young women']","['NCT', 'nursing intervention']","['HIV knowledge', 'condom use self-efficacy', 'HIV Risk Behavior Knowledge and the Condom Use Self-efficacy Scale']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",66.0,0.0506514,"The instruments were the Alcohol Use Disorders Identification Test, the HIV Risk Behavior Knowledge and the Condom Use Self-efficacy Scale.","[{'ForeName': 'Martha Dalila', 'Initials': 'MD', 'LastName': 'Mendez-Ruiz', 'Affiliation': 'Facultad de Enfermería de Nuevo Laredo, Universidad Autónoma de Tamaulipas, Nuevo Laredo, Tamaulipas, Mexico.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Villegas-Pantoja', 'Affiliation': 'Facultad de Enfermería de Nuevo Laredo, Universidad Autónoma de Tamaulipas, Nuevo Laredo, Tamaulipas, Mexico.'}, {'ForeName': 'Nohemí Selene', 'Initials': 'NS', 'LastName': 'Alarcón-Luna', 'Affiliation': 'Facultad de Enfermería de Nuevo Laredo, Universidad Autónoma de Tamaulipas, Nuevo Laredo, Tamaulipas, Mexico.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Villegas', 'Affiliation': 'School of Nursing and Health Studies, University of Miami, Coral Gables, Florida, United States of America.'}, {'ForeName': 'Rosina', 'Initials': 'R', 'LastName': 'Cianelli', 'Affiliation': 'School of Nursing and Health Studies, University of Miami, Coral Gables, Florida, United States of America.'}, {'ForeName': 'Nilda', 'Initials': 'N', 'LastName': 'Peragallo-Montano', 'Affiliation': 'Chapel Hill School of Nursing, University of North Carolina, Chapel Hill, North Carolina, United States of America.'}]",Revista latino-americana de enfermagem,['10.1590/1518-8345.3393.3262']
762,31482510,Anterior Chamber Inflammation After Cataract Surgery: A Randomized Clinical Trial Comparing Bromfenac 0.09% to Dexamethasone 0.1.,"PURPOSE


To compare the efficacy of bromfenac 0.09% and dexamethasone 0.1% in the treatment of anterior chamber inflammation after uncomplicated cataract surgery.
METHODS


Seventy-six patients with senile cataracts and no other ocular comorbidities who underwent uneventful phacoemulsification were randomized 1:1 to receive dexamethasone ophthalmic suspension 0.1% or bromfenac ophthalmic solution 0.09% for 2 weeks. All patients were examined on the day before surgery and postoperatively at day 1, 3, 7, 9, 11, 14 and 30. Laser flare photometry was used to quantify anterior chamber inflammation and optical coherence tomography to measure macular thickness.
RESULTS


Bromfenac was as effective as dexamethasone in reducing inflammation in the anterior chamber of the eye. Laser flare increased the day after surgery and progressively decreased after starting the treatment with no statistically significant difference between dexamethasone and bromfenac at all time points. Visual acuity improved steadily after surgery in both groups. Mean macular thickness was similar in both the dexamethasone and bromfenac arms at 1 month.
CONCLUSIONS


Short-term therapy with topical bromfenac alone is as effective as dexamethasone in low-risk cataract surgery patients.
TRIAL REGISTRATION


ClinicalTrials.gov # NCT03317847; EudraCT # 2016-004358-14.
FUNDING


Santa Maria Nuova Hospital IRCCS, Reggio Emilia, Italy.",2019,Laser flare increased the day after surgery and progressively decreased after starting the treatment with no statistically significant difference between dexamethasone and bromfenac at all time points.,"['low-risk cataract surgery patients', 'anterior chamber inflammation after uncomplicated cataract surgery', 'Seventy-six patients with senile cataracts and no other ocular comorbidities who underwent uneventful phacoemulsification']","['dexamethasone', 'Dexamethasone', 'dexamethasone ophthalmic suspension 0.1% or bromfenac ophthalmic solution']","['Anterior Chamber Inflammation', 'Visual acuity', 'Laser flare', 'Mean macular thickness']","[{'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1096278', 'cui_str': 'Anterior chamber inflammation'}, {'cui': 'C4319622', 'cui_str': 'Seventy-six'}, {'cui': 'C0036646', 'cui_str': 'Age-related cataract (disorder)'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1245764', 'cui_str': 'Dexamethasone Ophthalmic Suspension'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C4237922', 'cui_str': 'bromfenac Ophthalmic Solution [Bromsite]'}]","[{'cui': 'C1096278', 'cui_str': 'Anterior chamber inflammation'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",76.0,0.0780763,Laser flare increased the day after surgery and progressively decreased after starting the treatment with no statistically significant difference between dexamethasone and bromfenac at all time points.,"[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Coassin', 'Affiliation': 'Ophthalmology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy. m.coassin@unicampus.it.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'De Maria', 'Affiliation': 'Ophthalmology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Mastrofilippo', 'Affiliation': 'Ophthalmology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Braglia', 'Affiliation': 'Clinical Trials and Statistics Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cimino', 'Affiliation': 'Ocular Immunology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Sartori', 'Affiliation': 'Ophthalmology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Fontana', 'Affiliation': 'Ophthalmology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}]",Advances in therapy,['10.1007/s12325-019-01076-4']
763,31482511,Long-Term Efficacy and Safety of Linagliptin in a Japanese Population with Type 2 Diabetes Aged ≥ 60 Years Treated with Basal Insulin: A Randomised Trial.,"INTRODUCTION


An estimated 4.3 million people aged ≥ 65 years with diabetes live in Japan. We evaluated the efficacy and safety of linagliptin in older Japanese patients with poorly controlled type 2 diabetes (T2DM).
METHODS


In this phase 4, randomised, placebo-controlled national study (part of a global study) conducted in Japan over a period of 52 weeks, 102 patients on stable treatment with basal insulin ± metformin/alpha-glucosidase inhibitors were randomised (1:1) to receive linagliptin 5 mg qd or placebo. The primary end point was the change in glycated haemoglobin (HbA1c) after 24 weeks of treatment, with additional analyses at 52 weeks.
RESULTS


Mean age and HbA1c of the study population were 71 years and 8.1%, respectively. Approximately two-thirds of participants were aged ≥ 70 years, two-thirds had macrovascular complications, approximately half had a baseline estimated glomerular filtration rate < 60 ml/min/1.73 m 2 , and two-thirds had a time since diagnosis of diabetes > 10 years. Significant HbA1c reductions with linagliptin vs. placebo were observed at 24 weeks, - 0.71% (95% CI - 0.96, - 0.45, p < 0.0001), and maintained at 52 weeks, - 0.58% (95% CI - 0.82, - 0.34, p < 0.0001). Linagliptin improved the chances of achieving a categorical HbA1c target (< 8.0% and < 7.0%) at 24 and 52 weeks in patients who were not at their respective target at the beginning of the study. Addition of linagliptin to insulin was associated with a numerical increase in the risk of any hypoglycaemia, but not in the risk of clinically significant hypoglycaemia, severe hypoglycaemia or recurring hypoglycaemia.
CONCLUSION


Linagliptin was effective in improving glucose control in Japanese patients aged ≥ 60 years with T2DM on stable glucose-lowering therapy with basal insulin. Linagliptin was well tolerated and no new safety concerns were raised. The results presented here are highly consistent with the results from the global study, which was conducted over a 24-week period.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT02240680.
FUNDING


Boehringer Ingelheim and Eli Lilly and Company Diabetes Alliance.",2019,"Significant HbA1c reductions with linagliptin vs. placebo were observed at 24 weeks, - 0.71% (95% CI - 0.96, - 0.45, p < 0.0001), and maintained at 52 weeks, - 0.58% (95% CI - 0.82, - 0.34, p < 0.0001).","['Approximately two-thirds of participants were aged\u2009≥', 'controlled national study (part of a global study) conducted in Japan over a period of 52\xa0weeks, 102 patients on stable treatment with basal insulin\u2009±\u2009metformin/alpha-glucosidase inhibitors', '65\xa0years with diabetes live in Japan', '60\xa0years with T2DM on stable glucose-lowering therapy with basal insulin', 'Japanese Population with Type 2 Diabetes Aged\u2009≥', '60 Years Treated with', 'Japanese patients aged\u2009≥', 'An estimated 4.3 million people aged\u2009≥', 'older Japanese patients with poorly controlled type 2 diabetes (T2DM']","['linagliptin 5\xa0mg qd or placebo', 'Linagliptin', 'linagliptin vs. placebo', 'placebo', 'Basal Insulin', 'linagliptin']","['change in glycated haemoglobin (HbA1c', 'macrovascular complications', 'glomerular filtration rate', 'hypoglycaemia, severe hypoglycaemia or recurring hypoglycaemia', 'chances of achieving a categorical HbA1c target', 'efficacy and safety', 'risk of any hypoglycaemia']","[{'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0205437', 'cui_str': 'Third (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1299007', 'cui_str': 'alpha-Glucosidase Inhibitors'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C4517759', 'cui_str': 'Four point three'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C3153993', 'cui_str': 'Linagliptin 5 MG'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1318607', 'cui_str': 'HBA1c target'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",102.0,0.419061,"Significant HbA1c reductions with linagliptin vs. placebo were observed at 24 weeks, - 0.71% (95% CI - 0.96, - 0.45, p < 0.0001), and maintained at 52 weeks, - 0.58% (95% CI - 0.82, - 0.34, p < 0.0001).","[{'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Araki', 'Affiliation': 'Department of Metabolic Medicine, Kumamoto University Faculty of Life Sciences, Kumamoto, Japan.'}, {'ForeName': 'Yuriko', 'Initials': 'Y', 'LastName': 'Unno', 'Affiliation': 'Medicine Division, Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan. y.unno@r-and-o.jp.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'Medicine Division, Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Sakamoto', 'Affiliation': 'Medicine Division, Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Miyamoto', 'Affiliation': 'Medicine Division, Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan.'}]",Advances in therapy,['10.1007/s12325-019-01065-7']
764,31401786,"Cardiovascular Risks, Bleeding Risks, and Clinical Events from 3 Phase III Trials of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis.","INTRODUCTION


This study assessed baseline cardiovascular (CV) risk factors, concomitant CV medication use, risk of major adverse cardiac events-plus (MACE-plus), and bleeding adverse events (AEs) in patients with idiopathic pulmonary fibrosis (IPF) in three randomized, placebo-controlled phase III trials of pirfenidone.
METHODS


Patients in the pirfenidone phase III trials were included. Patients with unstable or deteriorating cardiac disease within 6 months before enrollment were ineligible. Medical history at baseline and concomitant CV medication use during treatment were reported. A retrospective, blinded review of AE preferred terms was conducted to identify MACE-plus and bleeding events. Subgroup analyses examined the impact of concomitant CV medication use on how pirfenidone treatment affected clinical outcomes.
RESULTS


In total, 1247 patients were included [n = 623 pirfenidone (2403 mg/day) and n = 624 placebo]. The median age was 68 years, 74% were male, and 65% were current/former smokers. Commonly reported CV risk factors included hypertension (52%), obesity (44%), hypercholesterolemia (23%), and hyperlipidemia (23%). Pre-existing cardiac disorders included coronary artery disease (16%), myocardial infarction (5%), and atrial fibrillation (5%). Lipid-modifying agents (60%), antithrombotic agents (54%), and renin-angiotensin inhibitors (39%) were commonly used concomitant CV medications. The incidences of MACE-plus and bleeding events were similar between the pirfenidone and placebo groups (1.8% and 2.9% for MACE-plus events and 3.7% and 4.3% for bleeding events, respectively). Except for patients receiving heparin, pirfenidone had a beneficial effect compared with placebo on efficacy outcomes regardless of concomitant CV medications.
CONCLUSIONS


CV risk factors and comorbidities and use of concomitant CV medications are common in patients with IPF. Pirfenidone did not appear to increase the risk of CV or bleeding events. Use of several concomitant CV medications, including warfarin, did not appear to adversely impact pirfenidone's beneficial effect on efficacy outcomes.
TRIAL REGISTRATION


NCT00287716, NCT00287729, and NCT01366209.
FUNDING


F. Hoffmann-La Roche Ltd. and Genentech, Inc.",2019,"Except for patients receiving heparin, pirfenidone had a beneficial effect compared with placebo on efficacy outcomes regardless of concomitant CV medications.
","['Patients with Idiopathic Pulmonary Fibrosis', 'patients with IPF', 'Patients in the pirfenidone phase III trials were included', 'patients with idiopathic pulmonary fibrosis (IPF', '1247 patients were included [n\u2009=\u2009623 pirfenidone (2403\xa0mg/day) and n\u2009=\u2009624', 'Patients with unstable or deteriorating cardiac disease within 6\xa0months before enrollment were ineligible']","['placebo', 'Pirfenidone', 'warfarin', 'heparin, pirfenidone']","['incidences of MACE-plus and bleeding events', 'baseline cardiovascular (CV) risk factors, concomitant CV medication use, risk of major adverse cardiac events-plus (MACE-plus), and bleeding adverse events (AEs', 'Cardiovascular Risks, Bleeding Risks, and Clinical Events', 'hypercholesterolemia', 'myocardial infarction', 'coronary artery disease', 'MACE-plus and bleeding events', 'risk of CV or bleeding events', 'atrial fibrillation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085786', 'cui_str': 'Alveolitis, Fibrosing'}, {'cui': 'C0298067', 'cui_str': 'pirfenidone'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0443343', 'cui_str': 'Unstable status (qualifier value)'}, {'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0298067', 'cui_str': 'pirfenidone'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0019134', 'cui_str': 'heparin'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]",1247.0,0.0815733,"Except for patients receiving heparin, pirfenidone had a beneficial effect compared with placebo on efficacy outcomes regardless of concomitant CV medications.
","[{'ForeName': 'Marilyn K', 'Initials': 'MK', 'LastName': 'Glassberg', 'Affiliation': 'University of Miami Health System, Miami, FL, USA. MGlassbe@med.miami.edu.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Nathan', 'Affiliation': 'Inova Fairfax Hospital, Falls Church, VA, USA.'}, {'ForeName': 'Chin-Yu', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Morgenthien', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Stauffer', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Willis', 'Initials': 'W', 'LastName': 'Chou', 'Affiliation': 'FibroGen, San Francisco, CA, USA.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Noble', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}]",Advances in therapy,['10.1007/s12325-019-01052-y']
765,32200994,High-flow nasal-oxygenation-assisted fibreoptic tracheal intubation in critically ill patients with COVID-19 pneumonia: a prospective randomised controlled trial.,,2020,,['critically ill patients with COVID-19 pneumonia'],['High-flow nasal-oxygenation-assisted fibreoptic tracheal intubation'],[],"[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'TS-COV19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}]",[],,0.33431,,"[{'ForeName': 'Cai-Neng', 'Initials': 'CN', 'LastName': 'Wu', 'Affiliation': 'Guangzhou, China.'}, {'ForeName': 'Lin-Zhi', 'Initials': 'LZ', 'LastName': 'Xia', 'Affiliation': 'Wuhan, China.'}, {'ForeName': 'Kun-Hong', 'Initials': 'KH', 'LastName': 'Li', 'Affiliation': 'Wuhan, China.'}, {'ForeName': 'Wu-Hua', 'Initials': 'WH', 'LastName': 'Ma', 'Affiliation': 'Guangzhou, China.'}, {'ForeName': 'Dong-Nan', 'Initials': 'DN', 'LastName': 'Yu', 'Affiliation': 'Guangzhou, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Qu', 'Affiliation': 'Guangzhou, China.'}, {'ForeName': 'Bi-Xi', 'Initials': 'BX', 'LastName': 'Li', 'Affiliation': 'Wuhan, China. Electronic address: bxlee@sohu.com.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Guangzhou, China. Electronic address: yingcao1986@163.com.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.02.020']
766,29981566,Randomized comparison of caregivers' ability to use epinephrine autoinjectors and prefilled syringes for anaphylaxis.,"BACKGROUND


Caregivers often incorrectly use epinephrine autoinjectors. It is unclear whether this is due to insufficient training or a difficult-to-use tool. Furthermore, the high costs of epinephrine autoinjectors may limit their availability; so low-cost prefilled syringes may be the alternative.
OBJECTIVES AND METHODS


We performed a prospective randomized trial to compare successful epinephrine administration at four stages: after reading written instructions, and immediately after, 6 weeks, and 3 months following video training. The time required for successful epinephrine administration and failed steps in the administration of epinephrine autoinjectors and prefilled syringe were also investigated.
RESULTS


Complete data analysis of 113 participants (prefilled syringe group, n=57; EpiPen, n=56) was performed. Significantly more participants correctly demonstrated the use of prefilled syringes compared to EpiPen after reading instructions, and immediately following 6 weeks, and 3 months after video training. ((adjusted OR 26.17 (95%CI 8.2583.04), adjusted OR 4.07 (95%CI 1.29-12.86), adjusted OR 14.01 (95%CI 3.62-54.22)) and adjusted OR 31.44 (95%CI 5.73172.39), respectively) Four key step errors would likely result in failure of administration and were more common with EpiPen (14.0% vs. 2.3%, p<0.001). There were no statistically significant differences in time of successful administration between the two groups (p>0.05).
CONCLUSION


Epinephrine prefilled syringe was significantly easier to use with a higher rate of correct use compared to EpiPen over time. All four key step errors in the administration were more likely with EpiPen. The time required for successful epinephrine administration was not significantly different.",2018,"Significantly more participants correctly demonstrated the use of prefilled syringes compared to EpiPen after reading instructions, and immediately following 6 weeks, and 3 months after video training.","['113 participants (prefilled syringe group, n=57; EpiPen, n=56) was performed']","['Epinephrine', 'epinephrine', 'epinephrine autoinjectors and prefilled syringes']","['time required for successful epinephrine administration', 'time of successful administration']","[{'cui': 'C1609474', 'cui_str': 'Prefilled Syringe'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0591454', 'cui_str': 'Epipen'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C3880082', 'cui_str': 'Epinephrine autoinjector (physical object)'}, {'cui': 'C0039142', 'cui_str': 'Syringes'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]",113.0,0.197888,"Significantly more participants correctly demonstrated the use of prefilled syringes compared to EpiPen after reading instructions, and immediately following 6 weeks, and 3 months after video training.","[{'ForeName': 'Panadda', 'Initials': 'P', 'LastName': 'Suwan', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University, Bangkok, Thailand.'}, {'ForeName': 'Phatcharee', 'Initials': 'P', 'LastName': 'Praphaiphin', 'Affiliation': 'Branch of Pediatric Nursing, Nursing Department, Faculty of Medicine Vajira Hospital, Navamindradhiraj University, Bangkok, Thailand.'}, {'ForeName': 'Pantipa', 'Initials': 'P', 'LastName': 'Chatchatee', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}]",Asian Pacific journal of allergy and immunology,['10.12932/AP-020318-0275']
767,31794523,HIV preexposure prophylaxis with tenofovir disoproxil fumarate/emtricitabine and changes in kidney function and tubular health.,"OBJECTIVE


To evaluate the effects of HIV preexposure prophylaxis (PrEP) with tenofovir disoproxial fumurate (TDF)/emtricitabine (FTC) on kidney function and kidney tubular health.
DESIGN


The Iniciativa Profilaxis Pre-Exposicion open-label extension (iPrEx-OLE) study enrolled former PrEP trial participants to receive open-label TDF/FTC. This study included 123 iPrEx-OLE participants who demonstrated PrEP adherence.
METHODS


We compared estimated glomerular filtration rate calculated using serum creatinine (eGFRcr), serum cystatin C (eGFRcys), and in combination (eGFRcr-cys), and a panel of 14 urine biomarkers reflecting kidney tubular health before and 6 months after PrEP initiation.
RESULTS


At baseline, mean eGFRcr, eGFRcys, and eGFRcr-cys were 108.3, 107.0, and 111.1 ml/min per 1.73 m, respectively. Six months after PrEP initiation, eGFRcr declined by -4% (95% CI: -5.7 to -2.4%), eGFRcys declined by -3.3% (95% CI: -8.3 to 1.9%), and eGFRcr-cys declined by -4.1% (95% CI: -7.5 to -0.7%). From the urine biomarker panel, α1-microglobulin and β2-microglobulin increased by 22.7% (95% CI: 11.8--34.7%) and 14.1% (95% CI: -6.1 to 38.6%), whereas chitinase-3-like 1 protein and monocyte chemoattractant protein-1 decreased by -37.7% (95% CI: -53.0 to -17.3%) and -15.6% (95% CI: -31.6 to 4.2%), respectively. Ten of the 14 urine biomarkers, including albumin, had estimated changes of less than 12% with wide confidence intervals.
CONCLUSION


Six months of PrEP with TDF/FTC was associated with decreases in eGFRcr and eGFRcys. We also observed for the first time changes in flour of 14 urine biomarkers reflecting kidney tubular health. These findings demonstrate that PrEP has direct effects on eGFR and the proximal tubule.",2020,"Six months after PrEP initiation, eGFRcr declined by -4% (95% CI: -5.7 to -2.4%), eGFRcys declined by -3.3% (95% CI: -8.3 to 1.9%), and eGFRcr-cys declined by -4.1% (95% CI: -7.5 to -0.7%).","['123 iPrEx-OLE participants who demonstrated PrEP adherence', 'The Iniciativa Profilaxis Pre-Exposicion open-label extension (iPrEx-OLE) study enrolled former PrEP trial participants to receive']","['open-label TDF/FTC', 'HIV preexposure prophylaxis (PrEP) with tenofovir disoproxial fumurate (TDF)/emtricitabine (FTC', 'tenofovir disoproxil fumarate/emtricitabine', 'PrEP', 'TDF/FTC']","['glomerular filtration rate calculated using serum creatinine (eGFRcr), serum cystatin C (eGFRcys), and in combination (eGFRcr-cys), and a panel of 14 urine biomarkers reflecting kidney tubular health', 'mean eGFRcr, eGFRcys, and eGFRcr-cys', 'kidney function and kidney tubular health', 'kidney function and tubular health', 'eGFRcr-cys', 'eGFRcr', 'chitinase-3-like 1 protein and monocyte chemoattractant protein-1', 'eGFRcr and eGFRcys', 'urine biomarker panel, α1-microglobulin and β2-microglobulin', 'eGFRcys']","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}, {'cui': 'C0042037'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0332208', 'cui_str': 'Tubular (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0008145', 'cui_str': 'Chitinases'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0128897', 'cui_str': 'Chemokine (C-C Motif) Ligand 2'}]",,0.205812,"Six months after PrEP initiation, eGFRcr declined by -4% (95% CI: -5.7 to -2.4%), eGFRcys declined by -3.3% (95% CI: -8.3 to 1.9%), and eGFRcr-cys declined by -4.1% (95% CI: -7.5 to -0.7%).","[{'ForeName': 'Simon B', 'Initials': 'SB', 'LastName': 'Ascher', 'Affiliation': 'Kidney Health Research Collaborative, Department of Medicine, San Francisco Veterans Affairs Health Care System and University of California, San Francisco.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Scherzer', 'Affiliation': 'Kidney Health Research Collaborative, Department of Medicine, San Francisco Veterans Affairs Health Care System and University of California, San Francisco.'}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Estrella', 'Affiliation': 'Kidney Health Research Collaborative, Department of Medicine, San Francisco Veterans Affairs Health Care System and University of California, San Francisco.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Shigenaga', 'Affiliation': 'Kidney Health Research Collaborative, Department of Medicine, San Francisco Veterans Affairs Health Care System and University of California, San Francisco.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Spaulding', 'Affiliation': 'Kidney Health Research Collaborative, Department of Medicine, San Francisco Veterans Affairs Health Care System and University of California, San Francisco.'}, {'ForeName': 'David V', 'Initials': 'DV', 'LastName': 'Glidden', 'Affiliation': 'Department of Biostatistics and Epidemiology.'}, {'ForeName': 'Megha L', 'Initials': 'ML', 'LastName': 'Mehrotra', 'Affiliation': 'Department of Biostatistics and Epidemiology.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Defechereux', 'Affiliation': 'Gladstone Institutes, University of California.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Gandhi', 'Affiliation': 'Division of HIV, Infectious Diseases, and Global Medicine.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Grant', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Shlipak', 'Affiliation': 'Kidney Health Research Collaborative, Department of Medicine, San Francisco Veterans Affairs Health Care System and University of California, San Francisco.'}, {'ForeName': 'Vasantha', 'Initials': 'V', 'LastName': 'Jotwani', 'Affiliation': 'Kidney Health Research Collaborative, Department of Medicine, San Francisco Veterans Affairs Health Care System and University of California, San Francisco.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002456']
768,31257996,"A Single-Center, Randomized, Controlled Comparison of the Transradial vs Transfemoral Approach for Cerebral Angiography: A Learning Curve Analysis.","Purpose:  To compare the characteristics and learning curve of the transfemoral approach (TFA) vs the transradial approach (TRA) for cerebral angiography.  Materials and Methods:  Between February 2016 and April 2017, 101 patients undergoing cerebral angiography were enrolled. Fifty-one patients (mean age 67 years; 40 men) were randomized to TFA and 50 (mean age 68 years; 41 men) to TRA using a computer-generated random table. The patients' demographic and angiographic data were recorded and analyzed. The learning curve of a novice interventionist was analyzed for procedure time, puncture time, fluoroscopy time, and contrast volume as markers of technical proficiency with TFA compared with TRA. Median values are given with the interquartile range (IQR).  Results:  Procedure time [35 (IQR 30, 47.5) vs 31.0 (IQR 25.0, 48.9) minutes, p=0.16), fluoroscopy time [10.3 (IQR 7.6, 13.9) vs 9.4 (IQR 6.1, 17.6) minutes, p=0.70], contrast volume [105 (IQR 92, 120) vs 95.5 (IQR 90, 111.3) mL, p=0.13), radiation exposure [390.2 (IQR 268.2, 617.9) vs 455.8 (IQR 286.8, 602.3) mGy, p=0.74], and the number of catheter exchanges [1 (IQR 1, 3) vs 1 (IQR 1, 1), p=0.06] were not significantly different between the TFA and TRA groups, respectively, but puncture time was shorter with TFA than with TRA [0.6 (IQR 0.5, 1.1) vs 1 (IQR 0.6, 1.9) minutes, p=0.01]. The learning curve was steeper with TRA than with TFA in the beginning stages of training, but with increasing experience, the procedure and fluoroscopy times were better for TRA than for TFA. Training progress was made earlier in TRA.  Conclusion:  TRA is a reasonable alternative to TFA for cerebral angiography. TRA has a shorter learning curve for novice interventionists.",2019,"The learning curve was steeper with TRA than with TFA in the beginning stages of training, but with increasing experience, the procedure and fluoroscopy times were better for TRA than for TFA.","['Fifty-one patients (mean age 67 years; 40 men', 'February 2016 and April 2017, 101 patients undergoing cerebral angiography were enrolled', 'Cerebral Angiography']","['TRA', 'transfemoral approach (TFA) vs the transradial approach (TRA', 'Transradial vs Transfemoral Approach', 'TFA']","['fluoroscopy time', 'learning curve', 'number of catheter exchanges', 'procedure time, puncture time, fluoroscopy time, and contrast volume as markers of technical proficiency with TFA', 'radiation exposure', 'puncture time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0007767', 'cui_str': 'Cerebral Angiography'}]","[{'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2936637', 'cui_str': 'Learning Curve'}, {'cui': 'C0449806', 'cui_str': 'Number of catheters (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation (event)'}]",101.0,0.0586402,"The learning curve was steeper with TRA than with TFA in the beginning stages of training, but with increasing experience, the procedure and fluoroscopy times were better for TRA than for TFA.","[{'ForeName': 'Yandong', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Changzheng Hospital Affiliated to the Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Xingzhu', 'Initials': 'X', 'LastName': 'Wen', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Changzheng Hospital Affiliated to the Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Bai', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Changzheng Hospital Affiliated to the Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Xiangguo', 'Initials': 'X', 'LastName': 'Ji', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Changzheng Hospital Affiliated to the Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Kangkang', 'Initials': 'K', 'LastName': 'Zhi', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Changzheng Hospital Affiliated to the Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Lefeng', 'Initials': 'L', 'LastName': 'Qu', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Changzheng Hospital Affiliated to the Second Military Medical University, Shanghai, China.'}]",Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists,['10.1177/1526602819859285']
769,31932093,The Association between Medication Adherence and Visual Field Progression in the Collaborative Initial Glaucoma Treatment Study.,"PURPOSE


To evaluate the relationship between medication adherence and visual field progression in participants randomized to the medication arm of the Collaborative Initial Glaucoma Treatment Study (CIGTS).
DESIGN


The CIGTS was a randomized, multicenter clinical trial comparing initial treatment with topical medications to trabeculectomy for 607 participants with newly diagnosed glaucoma.
PARTICIPANTS


Three hundred seven participants randomized to the medication arm of the CIGTS.
METHODS


Participants were followed up at 6-month intervals for up to 10 years. Self-reported medication adherence and visual fields were measured. Medication adherence was assessed by telephone from responses to the question, ""Did you happen to miss any dose of your medication yesterday?"" The impact of medication adherence on mean deviation (MD) over time was assessed with a linear mixed regression model adjusting for the effects of baseline MD and age, cataract extraction, interactions, and time (through year 8, excluding time after crossover to surgery). Medication adherence was modeled as a cumulative sum of the number of prior visits where a missed dose of medication was reported.
MAIN OUTCOME MEASURE


Mean deviation over time.
RESULTS


Three hundred seven subjects (306 with adherence data) were randomized to treatment with topical medications and followed up for an average of 7.3 years (standard deviation, 2.3 years). One hundred forty-two subjects (46%) reported never missing a dose of medication over all available follow-up, 112 patients (37%) reported missing medication at up to one third of visits, 31 patients (10%) reported missing medication at one third to two thirds of visits, and 21 patients (7%) reported missing medication at more than two thirds of visits. Worse medication adherence was associated with loss of MD over time (P = 0.005). For subjects who reported never missing a dose of medication, the average predicted MD loss over 8 years was 0.62 dB, consistent with age-related loss (95% confidence interval [CI], 0.17-1.06; P = 0.007); subjects who reported missing medication doses at one third of visits had a loss of 1.42 dB (95% CI, 0.86-1.98; P < 0.0001); and subjects who reported missing medication doses at two thirds of visits showed a loss of 2.23 dB (95% CI, 1.19-3.26; P < 0.0001).
CONCLUSIONS


This longitudinal assessment demonstrated a statistically and clinically significant association between medication nonadherence and glaucomatous vision loss.",2020,Worse medication adherence was associated with loss of MD over time (P = 0.005).,"['Three hundred seven subjects (306 with adherence data', 'One hundred forty-two subjects (46%) reported never missing a dose of medication over all available follow-up', 'participants randomized to the medication arm of the Collaborative Initial Glaucoma Treatment Study (CIGTS', 'Three hundred seven participants randomized to the medication arm of the CIGTS', '607 participants with newly diagnosed glaucoma', 'Participants were followed up at 6-month intervals for up to 10 years']",['topical medications to trabeculectomy'],"['Self-reported medication adherence and visual fields', 'Mean deviation over time', 'Worse medication adherence', 'MD loss', 'missing medication', 'Medication adherence', 'mean deviation (MD', 'medication nonadherence and glaucomatous vision loss']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C3263686', 'cui_str': 'Ocular trabeculectomy'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0042826', 'cui_str': 'Visual Fields'}, {'cui': 'C1828170', 'cui_str': 'Visual field index - mean deviation (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0746935', 'cui_str': 'Medication Non-Adherence'}, {'cui': 'C3665346', 'cui_str': 'Unspecified visual loss'}]",607.0,0.0846201,Worse medication adherence was associated with loss of MD over time (P = 0.005).,"[{'ForeName': 'Paula Anne', 'Initials': 'PA', 'LastName': 'Newman-Casey', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Medical School, University of Michigan, Ann Arbor, Michigan. Electronic address: panewman@med.umich.edu.'}, {'ForeName': 'Leslie M', 'Initials': 'LM', 'LastName': 'Niziol', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Medical School, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Brenda W', 'Initials': 'BW', 'LastName': 'Gillespie', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Nancy K', 'Initials': 'NK', 'LastName': 'Janz', 'Affiliation': 'Department of Health Behavior and Health Education, School of Public Health, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Lichter', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Medical School, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Musch', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Medical School, University of Michigan, Ann Arbor, Michigan; Department of Epidemiology, School of Public Health, University of Michigan, Ann Arbor, Michigan.'}]",Ophthalmology,['10.1016/j.ophtha.2019.10.022']
770,32191763,Reduced Clostridioides difficile infection in a pragmatic stepped-wedge initiative using admission surveillance to detect colonization.,"BACKGROUND


Clostridioides difficile Infection (CDI) is a persistent healthcare issue. In the US, CDI is the most common infectious cause of hospital-onset (HO) diarrhea.
OBJECTIVE


Assess the impact of admission testing for toxigenic C. difficile colonization on the incidence of HO-CDI.
DESIGN


Pragmatic stepped-wedge Infection Control initiative.
SETTING


NorthShore University HealthSystem is a four-hospital system near Chicago, IL.
PATIENTS


All patients admitted to the four hospitals during the initiative.
INTERVENTIONS


From September 2017 through August 2018 we conducted a quality improvement program where admitted patients had a peri-rectal swab tested for toxigenic C. difficile. All colonized patients were placed into contact precautions.
MEASUREMENTS


We tested admissions who: i) had been hospitalized within two months, ii) had a past C. difficile positive test, and/or iii) were in a long-term care facility within six months. We measured compliance with all other practices to reduce the incidence of HO-CDI.
RESULTS


30% of admissions were tested and 8.3% were positive. In the year prior to the initiative (Period 1) there were 63,057 admitted patients when HO-CDI incidence was 5.96 cases/10,000 patient days. During the 12-month initiative (Period 2) there were 62,760 admissions and the HO-CDI incidence was 4.23 cases/10,000 patient days (p = 0.02). There were no other practice or antibiotic use changes. Continuing admission surveillance provided a HO-CDI incidence of 2.9 cases/10,000 patient days during the final 9 months of 2018 (p<0.0001 compared to Period 1), equaling <1 case/1,000 admissions.
LIMITATIONS


This was not a randomized controlled trial, and multiple prevention practices were in place at the time of the admission surveillance initiative.
CONCLUSION


Admission C. difficile surveillance testing is an important tool for preventing hospital-onset C. difficile infection.
REGISTRATION


This quality improvement initiative is registered at ClinicalTrials.gov. The unique registration identifier number is NCT04014608.",2020,There were no other practice or antibiotic use changes.,"['From September 2017 through August 2018 we conducted a quality improvement program where admitted patients had a peri-rectal swab tested for toxigenic C. difficile', 'NorthShore University HealthSystem is a four-hospital system near Chicago, IL', 'All patients admitted to the four hospitals during the initiative']",[],"['incidence of HO-CDI', 'past C. difficile positive test, and/or iii', 'HO-CDI incidence', 'Clostridioides difficile infection']","[{'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444215', 'cui_str': 'Rectal swab (specimen)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}]",[],"[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",63057.0,0.0514484,There were no other practice or antibiotic use changes.,"[{'ForeName': 'Lance R', 'Initials': 'LR', 'LastName': 'Peterson', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, NorthShore University HealthSystem, Evanston, Illinois, United States of America.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': ""O'Grady"", 'Affiliation': 'Chief Clinical Operations Officer, NorthShore University HealthSystem, Evanston, Illinois, United States of America.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Keegan', 'Affiliation': 'Department of Nursing, NorthShore University HealthSystem, Evanston, Illinois, United States of America.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Fisher', 'Affiliation': 'Department of Infection Control, NorthShore University HealthSystem, Evanston, Illinois, United States of America.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Zelencik', 'Affiliation': 'Department of Infection Control, NorthShore University HealthSystem, Evanston, Illinois, United States of America.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Kufner', 'Affiliation': 'Department of Infection Control, NorthShore University HealthSystem, Evanston, Illinois, United States of America.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Shah', 'Affiliation': 'Department of Infection Control, NorthShore University HealthSystem, Evanston, Illinois, United States of America.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lim', 'Affiliation': 'Department of Infection Control, NorthShore University HealthSystem, Evanston, Illinois, United States of America.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Schora', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Division of Microbiology, NorthShore University HealthSystem, Evanston, Illinois, United States of America.'}, {'ForeName': 'Sanchita', 'Initials': 'S', 'LastName': 'Das', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Division of Microbiology, NorthShore University HealthSystem, Evanston, Illinois, United States of America.'}, {'ForeName': 'Kamaljit', 'Initials': 'K', 'LastName': 'Singh', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, NorthShore University HealthSystem, Evanston, Illinois, United States of America.'}]",PloS one,['10.1371/journal.pone.0230475']
771,32191766,Effect of intraoperative Hartmann's versus hypotonic solution administration on FLACC pain scale scores in children: A prospective randomized controlled trial.,"BACKGROUND


In healthy children, an isotonic solution containing no glucose or a small amount of glucose (1-2%) has been recommended as an intraoperative maintenance fluid due to the potential risk of hyponatremia associated with hypotonic solutions. However, a hypotonic solution with glucose is still widely used as a maintenance fluid for pediatric anesthesia. We speculated that the hypotonic solution may worsen postoperative discomfort and irritability in pediatric patients due to hyponatremia.
PATIENTS AND METHODS


In the current study, we compared the post-operative Face, Legs, Activity, Cry, Consolability(FLACC) scale scores of pediatric patients aged 3-10 years who received either a 1:2 dextrose solution or Hartmann's solution during Nuss Bar removal.
RESULTS


The FLACC scale score in the post-anesthesia care unit was higher in the 1:2 dextrose solution group(HYPO) (n = 20) than in the Hartmann's solution group(ISO) (n = 20) (6.30 vs 4.70, p = 0.044, mean difference and 95% Confidence Interval(CI) was 1.6 (0.04 to 3.16)). We also compared opioid consumption at the post-anesthesia care unit. Total dose of fentanyl per body weight in the post-anesthesia care unit was also higher in the HYPO (0.59 vs 0.37 mcg/kg, p = 0.042, mean difference and 95% CI was 0.22 mcg/kg (0.030 to 0.402)).
CONCLUSIONS


Intraoperative use of the hypotonic solution in children causes increased FLACC scale scores, leading to higher opioid consumption in post-anesthesia care unit.",2020,The FLACC scale score in the post-anesthesia care unit was higher in the 1:2 dextrose solution group(HYPO),"['pediatric patients aged 3-10 years who received either a 1:2', 'children', 'healthy children', 'pediatric patients due to hyponatremia']","['hypotonic solution', 'hypotonic solution administration', ""dextrose solution or Hartmann's solution"", 'dextrose solution group(HYPO', ""intraoperative Hartmann's"", 'isotonic solution containing no glucose']","['Total dose of fentanyl per body weight', 'postoperative discomfort and irritability', 'FLACC pain scale scores', 'post-operative Face, Legs, Activity, Cry, Consolability(FLACC) scale scores', 'FLACC scale score', 'FLACC scale scores']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}]","[{'cui': 'C0020677', 'cui_str': 'Hypotonic Solutions'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0073385', 'cui_str': ""Hartmann's Solution""}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0022260', 'cui_str': 'Isotonic Solutions'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C0222045'}]",,0.274341,The FLACC scale score in the post-anesthesia care unit was higher in the 1:2 dextrose solution group(HYPO),"[{'ForeName': 'Mihyun', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Jiyoung', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Sungwon', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Minsoo', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Min Suk', 'Initials': 'MS', 'LastName': 'Chae', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Hyungmook', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}]",PloS one,['10.1371/journal.pone.0230556']
772,31821429,Effect of Fresh vs Standard-issue Red Blood Cell Transfusions on Multiple Organ Dysfunction Syndrome in Critically Ill Pediatric Patients: A Randomized Clinical Trial.,"Importance


The clinical consequences of red blood cell storage age for critically ill pediatric patients have not been examined in a large, randomized clinical trial.
Objective


To determine if the transfusion of fresh red blood cells (stored ≤7 days) reduced new or progressive multiple organ dysfunction syndrome compared with the use of standard-issue red blood cells in critically ill children.
Design, Setting, and Participants


The Age of Transfused Blood in Critically-Ill Children trial was an international, multicenter, blinded, randomized clinical trial, performed between February 2014 and November 2018 in 50 tertiary care centers. Pediatric patients between the ages of 3 days and 16 years were eligible if the first red blood cell transfusion was administered within 7 days of intensive care unit admission. A total of 15 568 patients were screened, and 13 308 were excluded.
Interventions


Patients were randomized to receive either fresh or standard-issue red blood cells. A total of 1538 patients were randomized with 768 patients in the fresh red blood cell group and 770 in the standard-issue group.
Main Outcomes and Measures


The primary outcome measure was new or progressive multiple organ dysfunction syndrome, measured for 28 days or to discharge or death.
Results


Among 1538 patients who were randomized, 1461 patients (95%) were included in the primary analysis (median age, 1.8 years; 47.3% girls), in which there were 728 patients randomized to the fresh red blood cell group and 733 to the standard-issue group. The median storage duration was 5 days (interquartile range [IQR], 4-6 days) in the fresh group vs 18 days (IQR, 12-25 days) in the standard-issue group (P < .001). There were no significant differences in new or progressive multiple organ dysfunction syndrome between fresh (147 of 728 [20.2%]) and standard-issue red blood cell groups (133 of 732 [18.2%]), with an unadjusted absolute risk difference of 2.0% (95% CI, -2.0% to 6.1%; P = .33). The prevalence of sepsis was 25.8% (160 of 619) in the fresh group and 25.3% (154 of 608) in the standard-issue group. The prevalence of acute respiratory distress syndrome was 6.6% (41 of 619) in the fresh group and 4.8% (29 of 608) in the standard-issue group. Intensive care unit mortality was 4.5% (33 of 728) in the fresh group vs 3.5 % (26 of 732) in the standard-issue group (P = .34).
Conclusions and Relevance


Among critically ill pediatric patients, the use of fresh red blood cells did not reduce the incidence of new or progressive multiple organ dysfunction syndrome (including mortality) compared with standard-issue red blood cells.
Trial Registration


ClinicalTrials.gov Identifier: NCT01977547.",2019,"Among critically ill pediatric patients, the use of fresh red blood cells did not reduce the incidence of new or progressive multiple organ dysfunction syndrome (including mortality) compared with standard-issue red blood cells.
","['1538 patients who were randomized, 1461 patients (95%) were included in the primary analysis (median age, 1.8 years; 47.3% girls), in which there were 728 patients randomized to the fresh red blood cell group and 733 to the standard-issue group', 'critically ill pediatric patients', 'A total of 15\u202f568 patients were screened, and 13\u202f308 were excluded', 'Pediatric patients between the ages of 3 days and 16 years were eligible if the first red blood cell transfusion was administered within 7 days of intensive care unit admission', 'Critically Ill Pediatric Patients', '1538 patients were randomized with 768 patients in the fresh red blood cell group and 770 in the standard-issue group', 'critically ill children', 'February 2014 and November 2018 in 50 tertiary care centers']","['Fresh vs Standard-issue Red Blood Cell Transfusions', 'fresh or standard-issue red blood cells']","['acute respiratory distress syndrome', 'prevalence of sepsis', 'new or progressive multiple organ dysfunction syndrome', 'median storage duration', 'new or progressive multiple organ dysfunction syndrome, measured for 28 days or to discharge or death', 'incidence of new or progressive multiple organ dysfunction syndrome (including mortality', 'Intensive care unit mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0086252', 'cui_str': 'Red Blood Cell Transfusion'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C4517873', 'cui_str': '770'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}]","[{'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0086252', 'cui_str': 'Red Blood Cell Transfusion'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}]","[{'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0026766', 'cui_str': 'Organ Dysfunction Syndrome, Multiple'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1698986', 'cui_str': 'Storage (procedure)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]",1538.0,0.188416,"Among critically ill pediatric patients, the use of fresh red blood cells did not reduce the incidence of new or progressive multiple organ dysfunction syndrome (including mortality) compared with standard-issue red blood cells.
","[{'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Spinella', 'Affiliation': 'Division of Critical Care, Department of Pediatrics, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Tucci', 'Affiliation': ""Division of Pediatric Critical Care, Centre Hospitalier Universitaire (CHU) Sainte-Justine, Université de Montréal and Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada.""}, {'ForeName': 'Dean A', 'Initials': 'DA', 'LastName': 'Fergusson', 'Affiliation': 'Ottawa Hospital Research Institute, Departments of Medicine & Surgery, University of Ottawa School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Lacroix', 'Affiliation': ""Division of Pediatric Critical Care, Centre Hospitalier Universitaire (CHU) Sainte-Justine, Université de Montréal and Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada.""}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Hébert', 'Affiliation': ""Département de médecine, Centre de recherche du CHUM and Chaire de médecine transfusionnelle Héma-Québec-Bayer de l'Université de Montréal, Centre hospitalier de l'Université de Montréal, Montreal, Quebec, Canada.""}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Leteurtre', 'Affiliation': 'Université de Lille, EA 2694-Santé publique: épidémiologie et qualité des soins, CHU Lille, Réanimation Pédiatrique, Lille, France.'}, {'ForeName': 'Kenneth B', 'Initials': 'KB', 'LastName': 'Schechtman', 'Affiliation': 'Division of Biostatistics, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Doctor', 'Affiliation': 'Division of Critical Care, Department of Pediatrics, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Berg', 'Affiliation': ""The Children's Hospital of Philadelphia, Anesthesiology and Critical Care, University of Pennsylvania, Philadelphia.""}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Bockelmann', 'Affiliation': 'Division of Critical Care, Department of Pediatrics, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'J Jaime', 'Initials': 'JJ', 'LastName': 'Caro', 'Affiliation': 'London School of Economics, London, United Kingdom.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Chiusolo', 'Affiliation': ""Department of Anesthesia and Critical Care, Bambino Gesù Children's Hospital, Rome, Italy.""}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Clayton', 'Affiliation': ""Division of Pediatric Critical, Department of Pediatrics, Centre Hospitalier Universitaire (CHU) Sainte-Justine Université de Montréal and Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada.""}, {'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Cholette', 'Affiliation': ""Division of Critical Care and Cardiology, Department of Pediatrics, University of Rochester Golisano Children's Hospital, Rochester, New York.""}, {'ForeName': 'Gonzalo Garcia', 'Initials': 'GG', 'LastName': 'Guerra', 'Affiliation': 'Department of Pediatrics, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Cassandra D', 'Initials': 'CD', 'LastName': 'Josephson', 'Affiliation': 'Departments of Pathology and Pediatrics, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Kusum', 'Initials': 'K', 'LastName': 'Menon', 'Affiliation': ""Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa, Canada.""}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Muszynski', 'Affiliation': ""Division of Critical Care Medicine, Department of Pediatrics, Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Marianne E', 'Initials': 'ME', 'LastName': 'Nellis', 'Affiliation': 'Division of Pediatric Critical Care, Department of Pediatrics, Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Amrita', 'Initials': 'A', 'LastName': 'Sarpal', 'Affiliation': ""Western University, Children's Hospital, London Health Sciences Centre, London, Ontario, Canada.""}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Schafer', 'Affiliation': 'Division of Critical Care, Department of Pediatrics, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Marie E', 'Initials': 'ME', 'LastName': 'Steiner', 'Affiliation': 'Division of Pediatric Hematology and Oncology, Division of Pediatric Critical Care Medicine, Department of Pediatrics, University of Minnesota Medical School, Minneapolis.'}, {'ForeName': 'Alexis F', 'Initials': 'AF', 'LastName': 'Turgeon', 'Affiliation': 'Research CHU de Québec-Université Laval Centre, Population Health and Optimal Health Practices and Research Unit, Trauma, Emergency, Critical Care Medicine, Université Laval and Department of Anesthesiology and Critical Care Medicine, Division of Critical Care Medicine, Faculty of Medicine, Université Laval, Québec City, Québec, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2019.17478']
773,32207667,Predictors and moderators of response to brief interventions among adolescents with risky alcohol and marijuana use.,"Background:  Brief interventions have shown promise in reducing adolescent alcohol and marijuana use. This manuscript presents a secondary analysis of a randomized trial that compared a brief parent motivational intervention (Family Check Up; FCU) to brief psychoeducation (PE) condition and found no effect of treatment condition on either binge drinking or marijuana use days. The current analyses explored whether the response to treatment may have varied as a function of six empirically-based baseline moderators and predictors: biological sex, age, race/ethnicity, mental health problems, parent-adolescent communication, and peer deviance.  Methods:  Data from the parent trial randomizing 102 parents to either the FCU ( n  = 51) or PE ( n  = 51) interventions were re-analyzed across four time points (baseline, 3-, 6-, and 12-months). Moderators and predictors were tested via a series of hierarchical linear models.  Results:  Parent-adolescent communication and peer deviance emerged as significant predictors of adolescent treatment response. Specifically, low-levels of parent-adolescent communication or peer deviance were associated with worse treatment response (i.e., significant  increases  in binge drinking days and marijuana use days) in the PE condition, but not in the FCU condition. Non-Hispanic Whites and girls had worse treatment response, regardless of treatment condition.  Conclusions:  The FCU condition appeared to mitigate risks of poor parent-adolescent communication and affiliation with deviant peers better than the PE condition. Clinical recommendations for decision-making around assignment to brief interventions are discussed.",2020,"Hispanic Whites and girls had worse treatment response, regardless of treatment condition.  ","['102 parents to either the FCU ( n \u2009=\u200951) or PE ( n \u2009=\u200951) interventions', 'Hispanic Whites and girls', 'adolescents with risky alcohol and marijuana use']",['parent motivational intervention (Family Check Up; FCU'],['low-levels of parent-adolescent communication or peer deviance'],"[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C4316909', 'cui_str': 'Marijuana Use'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",102.0,0.0201499,"Hispanic Whites and girls had worse treatment response, regardless of treatment condition.  ","[{'ForeName': 'Sara J', 'Initials': 'SJ', 'LastName': 'Becker', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Marceau', 'Affiliation': 'Department of Human Development and Family Studies, Purdue University, West Lafayette, Indiana, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Helseth', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Hernandez', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Spirito', 'Affiliation': 'Department of Psychiatry and Human Behavior, The Alpert Medical School of Brown University, Providence, Rhode Island, USA.'}]",Substance abuse,['10.1080/08897077.2020.1742271']
774,32403243,Effects of Aerobic Exercise on Cortisol Stress Reactivity in Response to the Trier Social Stress Test in Inpatients with Major Depressive Disorders: A Randomized Controlled Trial.,"Physical activity is associated with a favourable (blunted) cortisol stress reactivity in healthy people. However, evidence from experimental study and with psychiatric patients is missing. This study examines whether exercise training impacts on cortisol stress reactivity in inpatients with major depressive disorder (MDD). These new insights are important because the stress reactivity of healthy people and patients with severe symptoms of depression might differ. Methods: The study was designed as a randomized controlled trial (trial registration number: NCT02679053). In total, 25 patients (13 women, 12 men, mean age: 38.1 12.0 years) completed a laboratory stressor task before and after a six-week intervention period. Nine samples of salivary free cortisol were taken before and after the Trier social stress test (TSST). Fourteen participants took part in six weeks of aerobic exercise training, while 11 patients were allocated to the control condition. While the primary outcome of the study was depressive symptom severity, the focus of this paper is on one of the secondary outcomes (cortisol reactivity during the TSST). The impact of aerobic exercise training was examined with a repeated-measures analysis of variance. We also examined the association between change in depression and cortisol response via correlational analysis. Cortisol reactivity did not change from baseline to post-intervention, either in the intervention or the control group. Participation in six weeks of aerobic exercise training was not associated with participants' cortisol reactivity. Moreover, depressive symptom change was not associated with change in cortisol response. Aerobic exercise training was not associated with patients' stress reactivity in this study. Because many patients initially showed a relatively flat/blunted cortisol response curve, efforts might be needed to find out which treatments are most efficient to promote a normalization of HPA axis reactivity.",2020,"Cortisol reactivity did not change from baseline to post-intervention, either in the intervention or the control group.","['25 patients (13 women, 12 men, mean age: 38.1 12.0 years', 'Fourteen participants took part in six weeks of', 'Inpatients with Major Depressive Disorders', 'inpatients with major depressive disorder (MDD', 'healthy people']","['Aerobic Exercise', 'Aerobic exercise training', 'exercise training', 'aerobic exercise training']","['cortisol stress reactivity', 'depressive symptom change', 'secondary outcomes (cortisol reactivity during the TSST', 'cortisol response', 'depressive symptom severity', 'laboratory stressor task', 'Cortisol Stress Reactivity', ""participants' cortisol reactivity"", 'Cortisol reactivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]",25.0,0.0299703,"Cortisol reactivity did not change from baseline to post-intervention, either in the intervention or the control group.","[{'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Gerber', 'Affiliation': 'Sport Science Section, Department of Sport, Exercise and Health, University of Basel, CH-4052 Basel, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Imboden', 'Affiliation': 'Psychiatric Services Solothurn, 4503 Solothurn, Switzerland.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Beck', 'Affiliation': 'Clinic Sonnenhalde, 4125 Riehen, Switzerland.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Brand', 'Affiliation': 'Sport Science Section, Department of Sport, Exercise and Health, University of Basel, CH-4052 Basel, Switzerland.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Colledge', 'Affiliation': 'Sport Science Section, Department of Sport, Exercise and Health, University of Basel, CH-4052 Basel, Switzerland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Eckert', 'Affiliation': 'University Psychiatric Clinics (UPK), Neurobiology Laboratory for Brain Aging and Mental Health, University of Basel, 4002 Basel, Switzerland.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Holsboer-Trachsler', 'Affiliation': 'University Psychiatric Clinics (UPK), Center for Affective, Stress and Sleep Disorders, University of Basel, 4002 Basel, Switzerland.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Pühse', 'Affiliation': 'Sport Science Section, Department of Sport, Exercise and Health, University of Basel, CH-4052 Basel, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hatzinger', 'Affiliation': 'Psychiatric Services Solothurn, 4503 Solothurn, Switzerland.'}]",Journal of clinical medicine,['10.3390/jcm9051419']
775,32403259,Effects of 120 g/h of Carbohydrates Intake during a Mountain Marathon on Exercise-Induced Muscle Damage in Elite Runners.,"Background-exercise-induced muscle damage (EIMD) and internal exercise load are increased after competing in ultraendurance events such as mountain marathons. Adequate carbohydrate (CHO) intake during exercise optimizes athletic performance and could limit EIMD, reduce internal exercise load and, thus, improve recovery. Therefore, the aim of this study was to research into and compare the effects of high CHO intake (120 g/h) in terms of CHO intake recommendation (90 g/h) and regular CHO intake performed by ultraendurance athletes (60 g/h) during a mountain marathon, on exercise load and EIMD markers (creatine kinase (CK), lactate dehydrogenase (LDH), glutamic oxaloacetic transaminase (GOT), urea and creatinine). Materials and Methods-a randomized trial was carried out on 20 male elite runners who had previously undertaken nutritional and gut training, and who consumed different CHO dosages according to experimental (EXP-120 g/h), control (CON-90 g/h) and low CHO intake (LOW-60 g/h) groups during a ~4000 m cumulative slope mountain marathon. EIMD markers were analyzed before the race and 24 h afterwards. Internal exercise load was calculated based on rate of perceived exertion (RPE) during and after the marathon event. Results-internal exercise load during the mountain marathon was significantly lower ( p  = 0.019; η 2 p = 0.471) in EXP (3805 ± 281 AU) compared to LOW (4688 ± 705 AU) and CON (4692 ± 716 AU). Moreover, results revealed that the EXP group evidenced significantly lower CK ( p  = 0.019; η 2 p = 0.373), LDH ( p  < 0.001; η 2 p = 0.615) and GOT ( p  = 0.003; η 2 p = 0.500) values 24 h after the mountain marathon race compared to LOW and CON. Along these lines, EIMD and exercise load evidenced a close correlation (R = 0.742;  p  < 0.001). Conclusion: High CHO intake (120 g/h) during a mountain marathon could limit the EIMD observed by CK, LDH and GOT and internal exercise load compared to CHO ingestion of 60 and 90 g/h.",2020,Results-internal exercise load during the mountain marathon was significantly lower ( p  = 0.019; η 2 p = 0.471) in EXP (3805 ± 281 AU) compared to LOW (4688 ± 705 AU) and CON (4692 ± 716 AU).,"['Elite Runners', '20 male elite runners who had previously undertaken nutritional and gut training, and who consumed different CHO dosages according to experimental (EXP-120 g/h), control (CON-90 g/h) and low CHO intake (LOW-60 g/h) groups during a ~4000 m cumulative slope mountain marathon']","['high CHO intake', 'Carbohydrates Intake', '-exercise-induced muscle damage (EIMD']","['exercise load and EIMD markers (creatine kinase (CK), lactate dehydrogenase (LDH), glutamic oxaloacetic transaminase (GOT), urea and creatinine', 'rate of perceived exertion (RPE', 'regular CHO intake', 'GOT', 'CK']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0560020', 'cui_str': 'g/h'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442533', 'cui_str': 'Mountain'}, {'cui': 'C0168374', 'cui_str': 'Marathon composite resin'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",20.0,0.0227273,Results-internal exercise load during the mountain marathon was significantly lower ( p  = 0.019; η 2 p = 0.471) in EXP (3805 ± 281 AU) compared to LOW (4688 ± 705 AU) and CON (4692 ± 716 AU).,"[{'ForeName': 'Aitor', 'Initials': 'A', 'LastName': 'Viribay', 'Affiliation': 'Glut4Science, Physiology, Nutrition and Sport, 01004 Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'Arribalzaga', 'Affiliation': 'Institute of Biomedicine (IBIOMED), Physiotherapy Department, University of Leon, Campus de Vegazana, 24071 Leon, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Mielgo-Ayuso', 'Affiliation': 'Department of Biochemistry Molecular Biology and Physiology, Faculty of Health Sciences, University of Valladolid, 42004 Soria, Spain.'}, {'ForeName': 'Arkaitz', 'Initials': 'A', 'LastName': 'Castañeda-Babarro', 'Affiliation': 'Health, Physical Activity and Sports Science Laboratory, Department of Physical Activity and Sports, Faculty of Psychology and Education, University of Deusto, 48007 Bizkaia, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Seco-Calvo', 'Affiliation': 'Institute of Biomedicine (IBIOMED), Physiotherapy Department, University of Leon, Researcher at the Basque Country University, Campus de Vegazana, 24071 Leon, Spain.'}, {'ForeName': 'Aritz', 'Initials': 'A', 'LastName': 'Urdampilleta', 'Affiliation': 'Centro de Investigacion y de Formación ElikaEsport, 08290 Cerdanyola del Valles, Barcelona, Spain.'}]",Nutrients,['10.3390/nu12051367']
776,32403299,Exploring the Provider-Level Socio-Demographic Determinants of Diet Quality of Preschool-Aged Children Attending Family Childcare Homes.,"Since food preferences develop during early childhood and contribute to dietary patterns that can track into adulthood, it is critical to support healthy food environments in places where children spend significant amounts of time in, such as childcare. It is important to understand what factors influence the diet quality of children cared for in family childcare homes (FCCH).
METHODS


This study used baseline data from a cluster-randomized trial in FCCH, Healthy Start/Comienzos Sanos. Surveys capturing providers' socio-demographic characteristics were completed. Food and beverage consumptions were estimated using the Dietary Observation in Childcare protocol, and diet quality was calculated using the Healthy Eating Index (HEI)-2015. Comparison of mean HEI scores by provider socio-demographic variables were completed using ANOVAs, followed by multiple linear regression models for significant variables. Post-hoc ANOVA models compared mean HEI-2015 sub-components by income and ethnicity.
RESULTS


Significant differences in mean HEI-2015 scores were found for provider income level (less than $25,000, HEI: 64.8 vs. $25,001-$50,000: 62.9 vs. $75,001 or more: 56.2;  p  = 0.03), ethnicity (Non-Latinx: 56.6 vs. Latinx: 64.4;  p  = 0.002), language spoken outside of childcare (English: 58.6 vs. Spanish: 64.3,  p  = 0.005), and language spoken in childcare (English: 59.6 vs. Spanish: 64.4;  p  = 0.02). In linear regression models, a higher provider income ($75,001 or more) was negatively and significantly associated with the total HEI-2015 scores (β = -9.8, SE = 3.7;  p  = 0.009) vs. lower income (less than $25,000). When entering provider income and ethnicity to the same model, adjusting for Child and Adult Food Program (CACFP), only ethnicity was significant, with Latinx being positively associated with total HEI-2015 scores vs. non-Latinx (β = 6.5, SE = 2.4;  p  = 0.007). Statistically significant differences were found by ethnicity and language for greens/beans, total protein, and seafood and plant protein HEI-2015 component scores.
DISCUSSION


Lower income, and Latinx providers cared-for children had higher diet quality in FCCH compared to the other providers. Future studies should better understand what specific foods contribute to each of the HEI-2015 components in order to better tailor trainings and interventions.",2020,"Statistically significant differences were found by ethnicity and language for greens/beans, total protein, and seafood and plant protein HEI-2015 component scores.
","['Preschool-Aged Children Attending Family Childcare Homes', 'children cared for in family childcare homes (FCCH']",[],"['total HEI-2015 scores', 'language spoken outside of childcare', 'higher provider income', 'mean HEI-2015 scores', 'Healthy Eating Index', 'provider income level', 'mean HEI scores', 'ethnicity and language for greens/beans, total protein, and seafood and plant protein HEI-2015 component scores', 'diet quality']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0008067', 'cui_str': 'Puericulture'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0424919', 'cui_str': 'Language spoken'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0004896', 'cui_str': 'Bean'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0206208', 'cui_str': 'Seafood'}, {'cui': 'C0032089', 'cui_str': 'Plant Proteins'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",,0.0209457,"Statistically significant differences were found by ethnicity and language for greens/beans, total protein, and seafood and plant protein HEI-2015 component scores.
","[{'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Tovar', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Rhode Island, Kingston, RI 02881, USA.'}, {'ForeName': 'Patricia Markham', 'Initials': 'PM', 'LastName': 'Risica', 'Affiliation': 'Center for Health Promotion and Health Equity, Brown University, South Main Street, Providence, RI 02912, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ramirez', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Rhode Island, Kingston, RI 02881, USA.'}, {'ForeName': 'Noereem', 'Initials': 'N', 'LastName': 'Mena', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Rhode Island, Kingston, RI 02881, USA.'}, {'ForeName': 'Ingrid E', 'Initials': 'IE', 'LastName': 'Lofgren', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Rhode Island, Kingston, RI 02881, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Cooksey Stowers', 'Affiliation': 'Department of Allied Health Sciences, University of Connecticut, 358 Mansfield Rd, Storrs, CT 06269, USA.'}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'Gans', 'Affiliation': 'Human Development & Family Sciences, 348 Mansfield Road, Unit 1058, University of Connecticut, Storrs, CT 06269, USA.'}]",Nutrients,['10.3390/nu12051368']
777,31444706,Effect of Empagliflozin on Free Fatty Acids and Ketone Bodies in Japanese Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Trial.,"INTRODUCTION


We report a randomized, double-blind, placebo-controlled, 4-week study to investigate the effect of empagliflozin on free fatty acids and blood ketone bodies in Japanese patients with type 2 diabetes mellitus.
METHODS


Patients (baseline mean [standard deviation] glycated hemoglobin 7.91% [0.80%]; body mass index 24.3 [3.2] kg/m 2 ) were randomized to empagliflozin 10 mg (n = 20), empagliflozin 25 mg (n = 19), or placebo (n = 21) daily as monotherapy for 28 days. Meal tolerance tests (MTTs; breakfast, lunch, dinner) were performed on day - 1, day 1 (first day of treatment), and day 28. On day 1 and day 28, study drug was administered 1 h before breakfast. Free fatty acids and blood ketone bodies were measured before and 1, 2, and 3 h after each MTT, and the next morning (overnight fast).
RESULTS


Empagliflozin significantly reduced plasma glucose and insulin and reduced body weight vs. placebo. Empagliflozin increased free fatty acids and total ketones bodies at day 1 and day 28. At day 28, the adjusted mean (95% confidence interval) difference vs. placebo in the time-corrected area under curve over 24 h for total ketone bodies was 67.1 (12.3, 121.8) µmol·h/L·h (P = 0.017) with empagliflozin 10 mg and 178.1 (123.9, 232.2) µmol·h/L·h (P < 0.001) with empagliflozin 25 mg. Increases in ketones with empagliflozin vs. placebo peaked just before and declined after meals, with the highest peak before breakfast. Changes in total ketone bodies appeared to be associated with changes in plasma glucose, insulin, and free fatty acids.
CONCLUSION


Empagliflozin modestly increased free fatty acids and blood ketone bodies after a single dose and 28 days' treatment. Increases in ketones appeared to be related to the duration of fasting and were most pronounced before breakfast. Increases in ketones appeared to be associated with changes in well-known metabolic determinants of ketone production.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT01947855.
FUNDING


Boehringer Ingelheim & Eli Lilly and Company.",2019,Empagliflozin modestly increased free fatty acids and blood ketone bodies after a single dose and 28 days' treatment.,"['Japanese Patients with Type 2 Diabetes Mellitus', 'Japanese patients with type 2 diabetes mellitus', 'Patients (baseline mean [standard deviation] glycated hemoglobin 7.91% [0.80%]; body mass index 24.3 [3.2] kg/m 2 ']","['Empagliflozin', 'empagliflozin', 'placebo', 'empagliflozin 25\xa0mg (n\u2009=\u200919), or placebo', 'empagliflozin vs. placebo', 'L·h']","['Meal tolerance tests (MTTs; breakfast, lunch, dinner', 'free fatty acids and total ketones bodies', 'Free Fatty Acids and Ketone Bodies', 'free fatty acids and blood ketone bodies', 'plasma glucose and insulin and reduced body weight vs. placebo', 'total ketone bodies', 'Free fatty acids and blood ketone bodies', 'plasma glucose, insulin, and free fatty acids']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517687', 'cui_str': '3.2'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3848929', 'cui_str': 'empagliflozin 25 MG'}]","[{'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0201777', 'cui_str': 'Tolerance test (procedure)'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C4552592', 'cui_str': 'With dinner'}, {'cui': 'C0373606', 'cui_str': 'Free fatty acids measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202110', 'cui_str': 'Ketone bodies measurement, quantitative (procedure)'}, {'cui': 'C1112671', 'cui_str': 'Blood ketone body'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0333779', 'cui_str': 'Reducing bodies (morphologic abnormality)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",,0.209601,Empagliflozin modestly increased free fatty acids and blood ketone bodies after a single dose and 28 days' treatment.,"[{'ForeName': 'Rimei', 'Initials': 'R', 'LastName': 'Nishimura', 'Affiliation': 'Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan. yuko.tanaka@boehringer-ingelheim.com.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Koiwai', 'Affiliation': 'Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Ishida', 'Affiliation': 'Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Salsali', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kaspers', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Kohler', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Søren S', 'Initials': 'SS', 'LastName': 'Lund', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}]",Advances in therapy,['10.1007/s12325-019-01045-x']
778,31420794,Photobiomodulation effect on local hemoglobin concentration assessed by near-infrared spectroscopy in humans.,"Exposure of biological tissue to photobiomodulation therapy (PBMT) seems to increase the oxygen availability and mitochondrial electrochemical activity. With the advancement of new technologies, such as near-infrared spectroscopy (NIRS), information can be obtained about the balance between oxygen utilization and delivery by assessing local oxy- ([O 2 Hb]) and deoxy-myohemoglobin ([HHb]) concentrations, both measured in micromolars (μM). Consequently, NIRS can be used to study (""in vivo"") PBMT effects on the oxidative system, including oxygen availability. Thus, the main objective of the present study was to use NIRS to investigate the acute effects of PBMT by light-emitting diode (LED) on the oxygen delivery and utilization in humans. Twelve healthy young participants were treated with a LED device (850 nm, 50 mW, 2 J) and placebo applied over the proximal third of the flexor carpi ulnaris muscle of the left or right forearm selected in a random order. The LED was applied in direct contact with skin and the device was switched on for 40 s in 4 different interventions (I 1 , I 2 , I 3  and I 4 ) with a 3-min interval between interventions. The placebo condition was considered as the period before the first PBMT. The NIRS device was used to evaluate the relative changes in [O 2 Hb] and [HHb] before and after placebo and interventions. We found that PBMT statistically increased the [O 2 Hb] in 0.39 μM. These results demonstrate the potential of PBMT to increase oxygen availability.",2020,Exposure of biological tissue to photobiomodulation therapy (PBMT) seems to increase the oxygen availability and mitochondrial electrochemical activity.,"['humans', 'Twelve healthy young participants']","['LED device', 'PBMT by light-emitting diode (LED', 'placebo', 'PBMT', 'photobiomodulation therapy (PBMT']","['local hemoglobin concentration', 'deoxy-myohemoglobin ([HHb]) concentrations, both measured in micromolars (μM', 'oxidative system, including oxygen availability', 'oxygen availability and mitochondrial electrochemical activity']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4019433', 'cui_str': 'LLLT'}]","[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439300', 'cui_str': 'nmol/mL'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",12.0,0.0443943,Exposure of biological tissue to photobiomodulation therapy (PBMT) seems to increase the oxygen availability and mitochondrial electrochemical activity.,"[{'ForeName': 'Stephanie Nogueira', 'Initials': 'SN', 'LastName': 'Linares', 'Affiliation': 'Cardiovascular Physical Therapy Laboratory, Department of Physical Therapy, Federal University of São Carlos, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Beltrame', 'Affiliation': 'Cardiovascular Physical Therapy Laboratory, Department of Physical Therapy, Federal University of São Carlos, São Carlos, São Paulo, Brazil. beltramethomas@gmail.com.'}, {'ForeName': 'Cleber', 'Initials': 'C', 'LastName': 'Ferraresi', 'Affiliation': 'Biomedical Engineering Postgraduate Program, Universidade Brasil, São Paulo, Brazil.'}, {'ForeName': 'Gabriela Aguiar Mesquita', 'Initials': 'GAM', 'LastName': 'Galdino', 'Affiliation': 'Cardiovascular Physical Therapy Laboratory, Department of Physical Therapy, Federal University of São Carlos, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Aparecida Maria', 'Initials': 'AM', 'LastName': 'Catai', 'Affiliation': 'Cardiovascular Physical Therapy Laboratory, Department of Physical Therapy, Federal University of São Carlos, São Carlos, São Paulo, Brazil.'}]",Lasers in medical science,['10.1007/s10103-019-02861-x']
779,32199861,Operating Room Virtual Reality Immersion Improves Self-Efficacy Amongst Preclinical Physician Assistant Students.,"OBJECTIVE


To assess the impact on self-efficacy for preclinical physician assistant (PA) students through immersive virtual reality (VR) operating room simulation.
DESIGN


Randomized double-blinded controlled experiment measuring self-efficacy using Schwarzer and Jerusalem's general self-efficacy scale. An entirely novel operating room was created, casted, and filmed using VR software. Fifty-two preclinical PA students were randomly assigned to VR (n = 26) or traditional lecture (n = 26) and self-efficacy was measured in both conditions using a general self-efficacy scale given before and after the virtual experience. A mixed ANOVA, independent sample t tests, and paired samples t tests were performed.
SETTING


Shenandoah University Physician Assistant program, Winchester, Virginia.
RESULTS


Exposure to VR training after the traditional lecture improves self-efficacy amongst PA students (p < 0.05). Exposure to VR improved self-efficacy compared to traditional methods (p < 0.05). There was no difference in self-efficacy amongst PA students with the traditional model (p < 0.05).
CONCLUSIONS


The introduction of VR simulation improved preclinical PA student self-efficacy in the operating room setting.",2020,"RESULTS


Exposure to VR training after the traditional lecture improves self-efficacy amongst PA students (p < 0.05).","['Shenandoah University Physician Assistant program, Winchester, Virginia', 'Fifty-two preclinical PA students', 'Preclinical Physician Assistant Students']",['traditional lecture'],"['preclinical PA student self-efficacy', 'self-efficacy']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0031833', 'cui_str': ""Physicians' Extenders""}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0042753', 'cui_str': 'Virginia'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}]","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",52.0,0.0131936,"RESULTS


Exposure to VR training after the traditional lecture improves self-efficacy amongst PA students (p < 0.05).","[{'ForeName': 'Erika R', 'Initials': 'ER', 'LastName': 'Francis', 'Affiliation': 'University, School of Health Professions, Division of Physician Assistant Studies, Winchester, Virginia. Electronic address: efrancis11@su.edu.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Bernard', 'Affiliation': 'University, School of Health Professions, Division of Physician Assistant Studies, Winchester, Virginia.'}, {'ForeName': 'Morgan L', 'Initials': 'ML', 'LastName': 'Nowak', 'Affiliation': 'University, School of Health Professions, Division of Physician Assistant Studies, Winchester, Virginia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Daniel', 'Affiliation': 'Shenandoah University, School of Education and Leadership, Winchester, Virginia.'}, {'ForeName': 'Johnathan A', 'Initials': 'JA', 'LastName': 'Bernard', 'Affiliation': 'OrthoVirginia, Herndon, Virginia.'}]",Journal of surgical education,['10.1016/j.jsurg.2020.02.013']
780,31303479,Patients beliefs and attitudes towards deprescribing: Can deprescribing success be predicted?,"BACKGROUND


The ability of questionnaires such as the Patients' Attitudes Towards Deprescribing (PATD) or the Beliefs about Medicines Questionnaire (Specific section) (BMQ-Specific) to successfully identify patients who will deprescribe remains unknown.
OBJECTIVE


To determine if screening questionnaires assessing patients' attitudes and beliefs towards medications and deprescribing can predict deprescribing outcomes.
METHODS


This is a post-hoc secondary analysis of the D-PRESCRIBE trial. 489 community-dwelling adults (≥65 years) who were chronic users (≥3 months) of a potentially inappropriate medication were randomized to a pharmacist-led educational intervention or usual care. Association between baseline responses to PATD and BMQ-Specific items and successful deprescribing was calculated. To determine predictive ability of questionnaire items, receiver operating characteristic curves (ROC) were constructed and area under the curve was calculated.
RESULTS


At baseline, 86% of participants (95% confidence interval [CI] 83-89%) indicated a willingness to deprescribe, yet only 41% (95%CI 37-46%) successfully deprescribed. Six items were associated with deprescribing success, however, no PATD or BMQ-Specific item - either independently or in combination - meaningfully distinguished which participants succeeded or failed deprescribing attempts at 6-months (AUC < 0.7).
CONCLUSION


Current tools to assess patient's attitudes and beliefs towards medication use and/or deprescribing have low predictive validity for successful deprescribing.",2020,"At baseline, 86% of participants (95% confidence interval [CI] 83-89%) indicated a willingness to deprescribe, yet only 41% (95%CI 37-46%) successfully deprescribed.","['489 community-dwelling adults (≥65 years) who were chronic users (≥3 months) of a potentially inappropriate medication', ""Patients' Attitudes""]",['pharmacist-led educational intervention or usual care'],[],"[{'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4042848', 'cui_str': 'Potentially Inappropriate Medications'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]",[],489.0,0.109975,"At baseline, 86% of participants (95% confidence interval [CI] 83-89%) indicated a willingness to deprescribe, yet only 41% (95%CI 37-46%) successfully deprescribed.","[{'ForeName': 'Justin P', 'Initials': 'JP', 'LastName': 'Turner', 'Affiliation': 'Faculty of Pharmacy, Université de Montréal, Montréal, Québec, Canada; Centre de Recherche, Institut Universitaire de Gériatrie de Montréal, Montréal, Québec, Canada. Electronic address: justin.turner@criugm.qc.ca.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Martin', 'Affiliation': 'Faculty of Pharmacy, Université de Montréal, Montréal, Québec, Canada; Centre de Recherche, Institut Universitaire de Gériatrie de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Yi Zhi', 'Initials': 'YZ', 'LastName': 'Zhang', 'Affiliation': 'Faculty of Pharmacy, Université de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Tannenbaum', 'Affiliation': 'Faculty of Pharmacy, Université de Montréal, Montréal, Québec, Canada; Centre de Recherche, Institut Universitaire de Gériatrie de Montréal, Montréal, Québec, Canada; Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada.'}]",Research in social & administrative pharmacy : RSAP,['10.1016/j.sapharm.2019.07.007']
781,30655053,Application of Adaptive Statistical Iterative Reconstruction-V With Combination of 80 kV for Reducing Radiation Dose and Improving Image Quality in Renal Computed Tomography Angiography for Slim Patients.,"OBJECTIVES


To explore the application of adaptive statistical iterative reconstruction-V (ASIR-V) with combination of 80 kV for reducing radiation dose and improving image quality in renal computed tomography angiography (CTA) for slim patients compared with traditional filtered back projection (FBP) reconstruction using 120 kV.
METHODS


Eighty patients for renal CTA were prospectively enrolled and randomly divided into group A and group B. Group A used 120 kV and 600 mgI/kg contrast agent and FBP reconstruction, while group B used 80 kV and 350 mgI/kg contrast agent and both FBP and ASIR-V reconstruction from 10%ASIR-V to 100%ASIR-V with 10%ASIR-V interval. The CT values and SD values of the right renal artery and left renal artery were measured to calculate the signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR). The image quality was subjectively scored by two experienced radiologists blindly using a five-point criterion. The contrast agent, volumetric CT dose index (CTDI vol ), and dose length product in both groups were recorded and the effective radiation dose was calculated.
RESULTS


There were no significant difference in patient characteristics between two groups (p > 0.05). The CTDI vol , dose length product and effective radiation dose in group B were 59.0%, 65.0%, and 65.1% lower than those in group A, respectively (all p < 0.05), and the contrast agent in group B was 42.2% lower than that in group A (p < 0.05). In group B, with the increase of ASIR-V percentage, CT values showed no significant difference, SD values decreased gradually, SNR values and CNR values increased gradually. The CT values showed no statistically significant difference (p > 0.05) between two groups with different reconstructions. The SD values with 40%ASIR-V to 100%ASIR-V reconstruction in group B was significantly lower(p < 0.5), while the SNR values with 50% ASIR-V to 100% ASIR-V reconstruction and CNR values with 70%ASIR-V to 100%ASIR-V were significantly higher than those of group A with FBP reconstruction (p < 0.5). Two radiologists had excellent consistency in subjective scores of image quality for renal CTA (kappa >0.75, p < 0.05). The subjective scores with 60% ASIR-V to 90% ASIR-V in group B were significantly higher than those of FBP in group A (p < 0.5), of which 70%ASIR-V reconstruction obtained the highest subjective score for renal CTA.
CONCLUSION


ASIR-V with combination of 80 kV can significantly reduce effective radiation dose (about 65.1%) and contrast agent (about 42.2%) and improve image quality in renal CTA for slim patients compared with traditional FBP reconstruction using 120 kV, and the 70% ASIR-V was the best reconstruction algorithm in 80 kV renal CTA.
ADVANCES IN KNOWLEDGE


Using 80 kV with combination of ASIR-V can significantly reduce radiation dose and contrast agent dose as well as improve image quality in renal CTA for thin patients when compared with FBP using 120 kV.",2019,"CONCLUSION


ASIR-V with combination of 80 kV can significantly reduce effective radiation dose (about 65.1%) and contrast agent (about 42.2%) and improve image quality in renal CTA for slim patients compared with traditional FBP reconstruction using 120 kV, and the 70% ASIR-V was the best reconstruction algorithm in 80 kV renal CTA.
","['Renal Computed Tomography Angiography for Slim Patients', 'Eighty patients for renal CTA']","['FBP', 'Adaptive Statistical Iterative Reconstruction-V With Combination of 80 kV for Reducing Radiation Dose', 'adaptive statistical iterative reconstruction-V (ASIR-V) with combination of 80 kV for reducing radiation dose and improving image quality in renal computed tomography angiography (CTA', 'traditional filtered back projection (FBP) reconstruction', '120 kV and 600 mgI/kg contrast agent and FBP reconstruction, while group B used 80 kV and 350 mgI/kg contrast agent and both FBP and ASIR-V reconstruction from 10%ASIR-V to 100%ASIR-V with 10%ASIR-V interval']","['signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR', 'volumetric CT dose index (CTDI vol ), and dose length product', 'CT values and SD values of the right renal artery and left renal artery', 'effective radiation dose', 'SNR values and CNR values', 'subjective scores', 'image quality', 'SNR values', 'patient characteristics', 'SD values', 'subjective scores of image quality for renal CTA', 'ASIR-V percentage, CT values', 'image quality in renal CTA']","[{'cui': 'C1536105', 'cui_str': 'Angiography, CT'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}]","[{'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0180860', 'cui_str': 'Filter, device (physical object)'}, {'cui': 'C0033363', 'cui_str': 'Projection'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0009924', 'cui_str': 'Contrast Agents'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1956110', 'cui_str': 'Cone-Beam Computerized Tomography'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0226332', 'cui_str': 'Structure of right renal artery'}, {'cui': 'C0226333', 'cui_str': 'Structure of left renal artery'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",80.0,0.0145217,"CONCLUSION


ASIR-V with combination of 80 kV can significantly reduce effective radiation dose (about 65.1%) and contrast agent (about 42.2%) and improve image quality in renal CTA for slim patients compared with traditional FBP reconstruction using 120 kV, and the 70% ASIR-V was the best reconstruction algorithm in 80 kV renal CTA.
","[{'ForeName': 'Zhanli', 'Initials': 'Z', 'LastName': 'Ren', 'Affiliation': 'Affiliated Hospital of Shaanxi University of Chinese Medicine, Weiyang western road- 2#, Xianyang, Shaanxi, China 712000; Shaanxi University of Chinese Medicine, Xianyang, Shaanxi, China; The Second Affiliated Hospital of Shaanxi University of Chinese Medicine, Xianyang, Shaanxi, China.'}, {'ForeName': 'Xirong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Affiliated Hospital of Shaanxi University of Chinese Medicine, Weiyang western road- 2#, Xianyang, Shaanxi, China 712000.'}, {'ForeName': 'Zhijun', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': ""Department of Medical Imaging, Chang'an Hospital, Xi'an, Shaanxi, China.""}, {'ForeName': 'Dou', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""Department of Medical Imaging, Chang'an Hospital, Xi'an, Shaanxi, China.""}, {'ForeName': 'Zhentang', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Department of Medical Imaging, Chang'an Hospital, Xi'an, Shaanxi, China.""}, {'ForeName': 'Donghong', 'Initials': 'D', 'LastName': 'Wei', 'Affiliation': ""Department of Medical Imaging, Chang'an Hospital, Xi'an, Shaanxi, China.""}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'Affiliated Hospital of Shaanxi University of Chinese Medicine, Weiyang western road- 2#, Xianyang, Shaanxi, China 712000.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Yu', 'Affiliation': 'Affiliated Hospital of Shaanxi University of Chinese Medicine, Weiyang western road- 2#, Xianyang, Shaanxi, China 712000.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Affiliated Hospital of Shaanxi University of Chinese Medicine, Weiyang western road- 2#, Xianyang, Shaanxi, China 712000.'}, {'ForeName': 'Yuxin', 'Initials': 'Y', 'LastName': 'Lei', 'Affiliation': 'Affiliated Hospital of Shaanxi University of Chinese Medicine, Weiyang western road- 2#, Xianyang, Shaanxi, China 712000.'}, {'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Affiliated Hospital of Shaanxi University of Chinese Medicine, Weiyang western road- 2#, Xianyang, Shaanxi, China 712000.'}, {'ForeName': 'Changyi', 'Initials': 'C', 'LastName': 'Guo', 'Affiliation': 'The Second Affiliated Hospital of Shaanxi University of Chinese Medicine, Xianyang, Shaanxi, China.'}, {'ForeName': 'Zhanliang', 'Initials': 'Z', 'LastName': 'Ren', 'Affiliation': 'Affiliated Hospital of Shaanxi University of Chinese Medicine, Weiyang western road- 2#, Xianyang, Shaanxi, China 712000. Electronic address: renzhanliang@163.com.'}, {'ForeName': 'Taiping', 'Initials': 'T', 'LastName': 'He', 'Affiliation': 'Affiliated Hospital of Shaanxi University of Chinese Medicine, Weiyang western road- 2#, Xianyang, Shaanxi, China 712000. Electronic address: htp89956@163.com.'}]",Academic radiology,['10.1016/j.acra.2018.12.021']
782,32171328,A randomized controlled trial of a six-session cognitive behavioral treatment of emotional disorders in adolescents 14-17 years old in child and adolescent mental health services (CAMHS).,"BACKGROUND


This study aims to investigate effectiveness of a 6-week, transdiagnostic cognitive behavioral therapy (CBT) for anxiety and depression in adolescents, the Structured Material for Therapy (SMART), in naturalistic settings of child and adolescent mental health outpatient services (CAMHS).
METHODS


A randomized controlled trial with waiting list control (WLC) was performed at three community CAMHS in Norway. Referred adolescents (N = 163, age = 15.72, 90.3% girls) scoring 6 or more on the emotional disorders subscale of the Strengths and Difficulties Questionnaire (SDQ) were randomly assigned to SMART or to WLC.
RESULTS


In the treatment group (CBT), 32.9% improved in the main outcome measure (SDQ), compared to 11.6% in the WLC. Clinically significant and reliable change was experienced by 17.7% in the CBT condition, compared to 5.8% in the WLC. No patients deteriorated. Statistically significant treatment effects were achieved for internalization symptoms, anxiety symptoms and general functioning.
CONCLUSIONS


These promising findings indicate that SMART may be considered as a first step in a stepped care model for anxiety and/or depression treatment in CAMHS. The recovery rates imply that further investigations into the effectiveness of brief treatments should be made. Furthermore, there is a need for more comprehensive second-stage treatments for some of these patients.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02150265. First registered May 292,014.",2020,"In the treatment group (CBT), 32.9% improved in the main outcome measure (SDQ), compared to 11.6% in the WLC.","['Referred adolescents (N\u2009=\u2009163, age\u2009=\u200915.72, 90.3% girls) scoring 6 or more on the emotional disorders subscale of the Strengths and Difficulties Questionnaire (SDQ', 'anxiety and depression in adolescents, the Structured Material for Therapy (SMART), in naturalistic settings of child and adolescent mental health outpatient services (CAMHS', 'emotional disorders in adolescents 14-17\u2009years old in child and adolescent mental health services (CAMHS']","['transdiagnostic cognitive behavioral therapy (CBT', 'waiting list control (WLC', 'six-session cognitive behavioral treatment']","['internalization symptoms, anxiety symptoms and general functioning', 'main outcome measure (SDQ']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0233459', 'cui_str': 'Emotional disorder'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire (assessment scale)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0086751', 'cui_str': 'Outpatient Services'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0025355', 'cui_str': 'Mental Hygiene Services'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}]",,0.0703199,"In the treatment group (CBT), 32.9% improved in the main outcome measure (SDQ), compared to 11.6% in the WLC.","[{'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Lorentzen', 'Affiliation': 'Department of Psychology, Faculty of Health Sciences, UIT The Arctic University of Norway, 9037, Tromsø, Norway. veronica.lorentzen@uit.no.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Fagermo', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Divisions of Child and Adolescent Health, University Hospital of North Norway, P.O. Box 19, 9038, Tromsø, Norway.'}, {'ForeName': 'Bjørn Helge', 'Initials': 'BH', 'LastName': 'Handegård', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare, UIT The Arctic University of Norway, 9037, Tromsø, Norway.'}, {'ForeName': 'Ingunn', 'Initials': 'I', 'LastName': 'Skre', 'Affiliation': 'Department of Psychology, Faculty of Health Sciences, UIT The Arctic University of Norway, 9037, Tromsø, Norway.'}, {'ForeName': 'Simon-Peter', 'Initials': 'SP', 'LastName': 'Neumer', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare, UIT The Arctic University of Norway, 9037, Tromsø, Norway.'}]",BMC psychology,['10.1186/s40359-020-0393-x']
783,31916828,The effects of aerobic training on subclinical negative affect: A randomized controlled trial.,"OBJECTIVE


The antidepressant and anxiolytic effects of aerobic exercise are well known, but less is known about its effects on subclinical levels of trait negative affect in healthy but sedentary adults. In the present study, we test the effects of a 3-month randomized controlled trial of aerobic exercise training in young to midlife adults on trait measures of depression, anxiety, hostility, and anger.
METHOD


One-hundred and 19 men (n = 56) and women (n = 63) aged 20-45 were randomized to 1 of 2 conditions: (a) 12 weeks of aerobic exercise after which they were asked to halt exercising and decondition for 4 weeks, or (b) a 16-week waitlist control group. Assessments of depression, anxiety, hostility and anger were completed at study entry, Week 12 and Week 16.
RESULTS


At study entry, participants scored low on measures of depression, anxiety, hostility and anger. Analyses among the intent-to-treat and per protocol samples found significant treatment effects of aerobic training for hostility and depression, but not for anxiety and anger. Within-group analyses demonstrated that depression and hostility scores decreased in the exercise group over the course of the intervention, while remaining stable in the control group. These effects persisted for the exercise group at nonsignificant levels after 4 weeks of deconditioning.
CONCLUSIONS


Aerobic exercise training has significant psychological effects even in sedentary yet euthymic adults, adding experimental data on the known benefits of exercise in this population. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,"Within-group analyses demonstrated that depression and hostility scores decreased in the exercise group over the course of the intervention, while remaining stable in the control group.","['sedentary yet euthymic adults', 'One-hundred and 19 men (n = 56) and women (n = 63', 'aged 20-45', 'healthy but sedentary adults', 'young to midlife adults']","['Aerobic exercise training', 'aerobic exercise', 'aerobic training', 'aerobic exercise training', 'aerobic exercise after which they were asked to halt exercising and decondition for 4 weeks, or (b) a 16-week waitlist control group']","['depression, anxiety, hostility and anger', 'depression, anxiety, hostility, and anger', 'depression and hostility scores']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0020039', 'cui_str': 'Hostility'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",2020.0,0.0592533,"Within-group analyses demonstrated that depression and hostility scores decreased in the exercise group over the course of the intervention, while remaining stable in the control group.","[{'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'McIntyre', 'Affiliation': 'Division of Behavioral Medicine, Department of Psychiatry, Columbia University Medical Center.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Puterman', 'Affiliation': 'School of Kinesiology, University of British Columbia.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Scodes', 'Affiliation': 'Mental Health Data Science, New York State Psychiatric Institute.'}, {'ForeName': 'Tse-Hwei', 'Initials': 'TH', 'LastName': 'Choo', 'Affiliation': 'Mental Health Data Science, New York State Psychiatric Institute.'}, {'ForeName': 'C Jean', 'Initials': 'CJ', 'LastName': 'Choi', 'Affiliation': 'Mental Health Data Science, New York State Psychiatric Institute.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': 'Department of Biostatistics, Mailman School of Public Health, Columbia University.'}, {'ForeName': 'Richard P', 'Initials': 'RP', 'LastName': 'Sloan', 'Affiliation': 'Department of Psychiatry, Columbia University Medical Center.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000836']
784,32186238,Effectiveness of elevated vacuum and suction prosthetic suspension systems in managing daily residual limb fluid volume change in people with transtibial amputation.,"BACKGROUND


Previous studies investigating limb volume change with elevated vacuum have shown inconsistent results and have been limited by out-of-socket volume measurements and short, single-activity protocols.
OBJECTIVES


To evaluate the effectiveness of elevated vacuum for managing limb fluid volume compared to suction suspension with an in-socket measurement modality during many hours of activity.
STUDY DESIGN


Fixed-order crossover design with a standardized out-of-laboratory activity protocol.
METHODS


Transtibial electronic elevated vacuum users participated in two sessions. Elevated vacuum was used during the first session, and suction suspension in the second. Participants completed a 5.5-h protocol consisting of multiple intervals of activity. In-socket residual limb fluid volume was continuously measured using a custom portable bioimpedance analyzer.
RESULTS


A total of 12 individuals participated. Overall rate of fluid volume change was not significantly different, though the rate of posterior fluid volume change during Cycle 3 was significantly lower with elevated vacuum. Although individual results varied, 11 participants experienced lower overall rates of fluid volume loss in at least one limb region using elevated vacuum.
CONCLUSION


Elevated vacuum may be more effective as a volume management strategy after accumulation of activity. Individual variation suggests the potential to optimize the limb fluid volume benefits of elevated vacuum by reducing socket vacuum pressure for some users.
CLINICAL RELEVANCE


A better understanding of how elevated vacuum (EV) affects residual limb fluid volume will allow prosthetists to make more informed clinical decisions regarding accommodation strategies designed to improve daily socket fit.",2020,"Overall rate of fluid volume change was not significantly different, though the rate of posterior fluid volume change during Cycle 3 was significantly lower with elevated vacuum.","['people with transtibial amputation', '12 individuals participated', 'Transtibial electronic elevated vacuum users participated in two sessions']","['elevated vacuum and suction prosthetic suspension systems', 'suction suspension']","['socket vacuum pressure', 'overall rates of fluid volume loss', 'Overall rate of fluid volume change']","[{'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}]","[{'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0038638', 'cui_str': 'Aspiration, Mechanical'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",12.0,0.198244,"Overall rate of fluid volume change was not significantly different, though the rate of posterior fluid volume change during Cycle 3 was significantly lower with elevated vacuum.","[{'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Youngblood', 'Affiliation': 'Department of Bioengineering, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Jacob T', 'Initials': 'JT', 'LastName': 'Brzostowski', 'Affiliation': 'Department of Bioengineering, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Hafner', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Czerniecki', 'Affiliation': 'VA Center for Limb Loss and Mobility, VA Puget Sound Health Care System, Seattle, WA, USA.'}, {'ForeName': 'Katheryn J', 'Initials': 'KJ', 'LastName': 'Allyn', 'Affiliation': 'Department of Bioengineering, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Foster', 'Affiliation': 'TGG Prosthetics & Orthotics, Edmond, OK, USA.'}, {'ForeName': 'Joan E', 'Initials': 'JE', 'LastName': 'Sanders', 'Affiliation': 'Department of Bioengineering, University of Washington, Seattle, WA, USA.'}]",Prosthetics and orthotics international,['10.1177/0309364620909044']
785,32182371,[Cognitive-behavioural group therapy for insomnia: evaluation of the results after its implementation in a health department].,"INTRODUCTION


Cognitive-behavioural therapy (CBT) is the preferred treatment in cases of chronic insomnia disorder in adults.
PATIENTS AND METHODS


Open pragmatic study of 32 patients after eight sessions of group CBT for insomnia.
RESULTS


Remission (insomnia severity index: 0-7 points) and response (insomnia severity index drops to > 8) were 31.3% and 46.9% at one month (n = 32) and 42.8% and 52.4% at one year (n = 21), respectively, with an effect size of 1.9 at one month and 2.3 at one year. At one month, 40.6% met the criteria for a case of insomnia (according to the insomnia symptoms questionnaire), and at one year, 19%, with a significant improvement in the symptoms at night and the consequences during the day. The questions of the Pittsburgh Sleep Quality Index on insomnia and sleep efficiency also improved. The pre-sleep arousal scale (n = 7) showed a shift from significant somatic and cognitive arousal to no arousal at one month. In the sleep diaries, total sleep time increased by an average of 53 minutes at one month (n = 14) and 76 minutes at one year (n = 10), with an increase of more than 10% in 71.4% of patients at one month and at one year, and an average sleep efficiency of more than 85%. The effect size for total sleep time and sleep efficiency was between 0.7 and 1.
CONCLUSIONS


Group CBT for insomnia appears to be an effective treatment option in a clinical setting.",2020,"RESULTS


Remission (insomnia severity index: 0-7 points) and response (insomnia severity index drops to > 8) were 31.3% and 46.9% at one month (n = 32) and 42.8% and 52.4% at one year (n = 21), respectively, with an effect size of 1.9 at one month and 2.3 at one year.","['cases of chronic insomnia disorder in adults', 'insomnia', '32 patients after eight sessions of group CBT for insomnia']","['Cognitive-behavioural therapy (CBT', 'Cognitive-behavioural group therapy']","['pre-sleep arousal scale', 'average sleep efficiency', 'insomnia symptoms questionnaire', 'total sleep time and sleep efficiency', 'somatic and cognitive arousal to no arousal', 'Pittsburgh Sleep Quality Index on insomnia and sleep efficiency', 'total sleep time', 'Remission (insomnia severity index: 0-7 points) and response (insomnia severity index drops']","[{'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0751249', 'cui_str': 'Chronic Insomnia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0222045'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}]",32.0,0.0127816,"RESULTS


Remission (insomnia severity index: 0-7 points) and response (insomnia severity index drops to > 8) were 31.3% and 46.9% at one month (n = 32) and 42.8% and 52.4% at one year (n = 21), respectively, with an effect size of 1.9 at one month and 2.3 at one year.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'de Entrambasaguas', 'Affiliation': 'Hospital Clínic Universitari de València, Valencia, España.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Aiko-Gesler', 'Affiliation': 'Hospital Clínic Universitari de València, Valencia, España.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Luciano', 'Affiliation': 'Hospital Clínic Universitari de València, Valencia, España.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Domínguez-Cabañero', 'Affiliation': 'Hospital Clínic Universitari de València, Valencia, España.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Terrés', 'Affiliation': 'Hospital Clínic Universitari de València, Valencia, España.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Diego-Castaño', 'Affiliation': 'Hospital Clínic Universitari de València, Valencia, España.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'González-Vivas', 'Affiliation': 'Hospital Clínic Universitari de València, Valencia, España.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'García-Parreño', 'Affiliation': 'Hospital Clínic Universitari de València, Valencia, España.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lorente-Rovira', 'Affiliation': 'Hospital Clínic Universitari de València, Valencia, España.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Herraiz', 'Affiliation': 'Hospital Clínic Universitari de València, Valencia, España.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Victorio', 'Affiliation': 'Hospital Clínic Universitari de València, Valencia, España.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Cases-Bergón', 'Affiliation': 'Hospital Clínic Universitari de València, Valencia, España.'}]",Revista de neurologia,['10.33588/rn.7007.2019385']
786,32492087,Efficacy and Safety of Abrocitinib in Patients With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial.,"Importance


Abrocitinib, an oral, once-daily Janus kinase 1 selective inhibitor, was effective and well tolerated in a phase 3 monotherapy trial of patients with moderate-to-severe atopic dermatitis (AD).
Objective


To investigate the efficacy and safety of abrocitinib in adolescents and adults with moderate-to-severe AD in an identically designed trial.
Design, Setting, and Participants


This phase 3, double-blinded, placebo-controlled, parallel-group randomized clinical trial included patients 12 years or older with a clinical diagnosis of moderate-to-severe AD for at least 1 year and inadequate response to topical medications given for at least 4 weeks within 6 months. Patients were enrolled from 115 centers in Australia, Bulgaria, Canada, China, Czechia, Germany, Hungary, Japan, South Korea, Latvia, Poland, United Kingdom, and the United States from June 29, 2018, to August 13, 2019. Data were analyzed from September 13 to October 25, 2019.
Interventions


Patients were randomly assigned (2:2:1) to receive once-daily oral abrocitinib in 200- or 100-mg doses or placebo for 12 weeks.
Main Outcomes and Measures


The coprimary end points were the proportion of patients achieving Investigator Global Assessment (IGA) response (ie, clear [0] or almost clear [1], with improvement of ≥2 grades) and the proportion of patients achieving at least 75% improvement in Eczema Area and Severity Index score (EASI-75) at week 12. Key secondary end points included the proportion of patients achieving a Peak Pruritus Numerical Rating Scale (PP-NRS) response (ie, improvement of ≥4 points) at week 12. Other secondary end points included the proportion of patients achieving at least 90% improvement in EASI score (EASI-90). Safety was assessed via adverse events and laboratory monitoring.
Results


A total of 391 patients (229 male [58.6%]; mean [SD] age, 35.1 [15.1] years) were included in the analysis; of these, 155 received abrocitinib, 200 mg/d; 158, abrocitinib, 100 mg/d; and 78, placebo. Among patients with available data at week 12, greater proportions of patients in the 200- and 100-mg abrocitinib groups vs the placebo group achieved IGA (59 of 155 [38.1%] and 44 of 155 [28.4%] vs 7 of 77 [9.1%]; P < .001) and EASI-75 (94 of 154 [61.0%] and 69 of 155 [44.5%] vs 8 of 77 [10.4%]; P < .001), greater estimated proportions achieved PP-NRS (55.3% [95% CI, 47.2%-63.5%] and 45.2% [95% CI, 37.1%-53.3%] vs 11.5% [95% CI, 4.1%-19.0%]; P < .001), and/or greater proportions achieved EASI-90 (58 of 154 [37.7%] and 37 of 155 [23.9%] vs 3 of 77 [3.9%]) responses. Adverse events were reported for 102 patients (65.8%) in the 200-mg group, 99 (62.7%) in the 100-mg group, and 42 (53.8%) in the placebo group; serious adverse events were reported for 2 patients (1.3%) in the 200-mg group, 5 (3.2%) in the 100-mg group, and 1 (1.3%) in the placebo group. Decreases in platelet count (2 [1.3%]) and laboratory values indicating thrombocytopenia (5 [3.2%]) were reported in the 200-mg group.
Conclusions and Relevance


Monotherapy with once-daily oral abrocitinib was effective and well tolerated in adolescents and adults with moderate-to-severe AD.
Trial Registration


ClinicalTrials.gov Identifier: NCT03575871.",2020,"Adverse events were reported for 102 patients (65.8%) in the 200-mg group, 99 (62.7%) in the 100-mg group, and 42 (53.8%) in the placebo group; serious adverse events were reported for 2 patients (1.3%) in the 200-mg group, 5 (3.2%) in the 100-mg group, and 1 (1.3%) in the placebo group.","['patients with moderate-to-severe atopic dermatitis (AD', 'adolescents and adults with moderate-to-severe AD', 'Patients were enrolled from 115 centers in Australia, Bulgaria, Canada, China, Czechia, Germany, Hungary, Japan, South Korea, Latvia, Poland, United Kingdom, and the United States from June 29, 2018, to August 13, 2019', 'Patients With Moderate-to-Severe Atopic Dermatitis', 'A total of 391 patients (229 male [58.6%]; mean [SD] age, 35.1 [15.1] years) were included in the analysis; of these, 155 received abrocitinib, 200 mg/d; 158, abrocitinib, 100 mg/d; and 78', 'adolescents and adults with moderate-to-severe AD in an identically designed trial', 'patients 12 years or older with a clinical diagnosis of moderate-to-severe AD for at least 1 year and inadequate response to topical medications given for at least 4 weeks within 6 months']","['Abrocitinib', 'abrocitinib', 'receive once-daily oral abrocitinib in 200- or 100-mg doses or placebo', 'placebo']","['Efficacy and Safety', 'platelet count', 'Adverse events', 'proportion of patients achieving a Peak Pruritus Numerical Rating Scale (PP-NRS) response (ie, improvement of ≥4 points', 'EASI-90', 'PP-NRS', 'thrombocytopenia', 'efficacy and safety', 'serious adverse events', 'EASI-75', 'proportion of patients achieving Investigator Global Assessment (IGA) response (ie, clear [0] or almost clear [1], with improvement of ≥2 grades) and the proportion of patients achieving at least 75% improvement in Eczema Area and Severity Index score (EASI-75', 'proportion of patients achieving at least 90% improvement in EASI score (EASI-90', 'IGA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0006368', 'cui_str': 'Bulgaria'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0206578', 'cui_str': 'Czech republic'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0020174', 'cui_str': 'Hungary'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0023128', 'cui_str': 'Latvia'}, {'cui': 'C0032356', 'cui_str': 'Poland'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0420210', 'cui_str': 'Medication given'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",391.0,0.644566,"Adverse events were reported for 102 patients (65.8%) in the 200-mg group, 99 (62.7%) in the 100-mg group, and 42 (53.8%) in the placebo group; serious adverse events were reported for 2 patients (1.3%) in the 200-mg group, 5 (3.2%) in the 100-mg group, and 1 (1.3%) in the placebo group.","[{'ForeName': 'Jonathan I', 'Initials': 'JI', 'LastName': 'Silverberg', 'Affiliation': 'Department of Dermatology, The George Washington University School of Medicine and Health Sciences, Washington, DC.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Department of Dermatology, Oregon Health & Science University, Portland.'}, {'ForeName': 'Jacob P', 'Initials': 'JP', 'LastName': 'Thyssen', 'Affiliation': 'Department of Dermatology and Allergy, Herlev-Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Gooderham', 'Affiliation': ""SKiN Centre for Dermatology, Queen's University and Probity Medical Research, Peterborough, Ontario, Canada.""}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Chan', 'Affiliation': 'Pfizer Inc, Groton, Connecticut.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Feeney', 'Affiliation': 'Pfizer Ltd, Surrey, United Kingdom.'}, {'ForeName': 'Pinaki', 'Initials': 'P', 'LastName': 'Biswas', 'Affiliation': 'Pfizer Inc, New York, New York.'}, {'ForeName': 'Hernan', 'Initials': 'H', 'LastName': 'Valdez', 'Affiliation': 'Pfizer Inc, New York, New York.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'DiBonaventura', 'Affiliation': 'Pfizer Inc, New York, New York.'}, {'ForeName': 'Chudy', 'Initials': 'C', 'LastName': 'Nduaka', 'Affiliation': 'Pfizer Inc, Collegeville, Pennsylvania.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Rojo', 'Affiliation': 'Pfizer Inc, Groton, Connecticut.'}]",JAMA dermatology,['10.1001/jamadermatol.2020.1406']
787,32191729,Improving Skin-to-Skin Practice for babies in Kangaroo Mother Care in Malawi through the use of a customized baby wrap: A randomized control trial.,"BACKGROUND


Complications of prematurity are a leading cause of newborn death in Malawi. Despite early adoption of Kangaroo mother care (KMC), coverage remains low and women have expressed challenges in using the traditional wrapper-chitenje. In 2016, a study was conducted to evaluate the acceptability and effectiveness of a customized KMC wrap in improving adherence to KMC practices among mothers.
METHODS


Mother-baby dyads (301) were randomized to receive either a customized CarePlus Wrap developed by Lærdal Global Health or a traditional chitenje. Enrolled mother-baby dyads were assessed in the KMC ward at 2-3 days after of admission, and then again at 7-15 days post-discharge. Topics covered included skin-to-skin practices, breastfeeding, perceptions of the wrap, and family/community support. Chi square tests were used to assess associations between wrap type and KMC practices. The study received ethics approval.
RESULTS


This study found that a customized KMC wrap is highly acceptable to women and improved skin-to-skin practices in facility-based KMC: 44% of mothers using a customized wrap reported 20 or more hours per day, compared to 33% of mothers using the traditional chitenje. Women using the customized wrap reported being comfortable in keeping the baby in skin-to-skin position more often than women using the chitenje (96% vs. 71%), and they were able to tie on the wrap themselves (86% vs. 10%). At the time of discharge from KMC, more women who used the customized wrap were satisfied with the wrap than those who used the traditional chitenje (94% vs. 56%). The customized wrap did not appear to impact other newborn practices, such as breastfeeding.
CONCLUSIONS


This study provides evidence that a customized KMC wrap is highly acceptable to mothers, and it can contribute to better skin-to-skin practices. Use of a customized wrap may be one mechanism to support mothers in practicing KMC and skin-to-skin contact in addition to other interventions.",2020,"Women using the customized wrap reported being comfortable in keeping the baby in skin-to-skin position more often than women using the chitenje (96% vs. 71%), and they were able to tie on the wrap themselves (86% vs. 10%).","['mothers', 'Mother-baby dyads (301']","['customized KMC wrap', 'customized KMC', 'customized CarePlus Wrap developed by Lærdal Global Health or a traditional chitenje']",['acceptability and effectiveness'],"[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0445414', 'cui_str': 'Wrapping (procedure)'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",301.0,0.0308244,"Women using the customized wrap reported being comfortable in keeping the baby in skin-to-skin position more often than women using the chitenje (96% vs. 71%), and they were able to tie on the wrap themselves (86% vs. 10%).","[{'ForeName': 'Kondwani', 'Initials': 'K', 'LastName': 'Chavula', 'Affiliation': 'Save the Children, Lilongwe, Malawi.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Guenther', 'Affiliation': 'Department of Global Health, Save the Children US, Washington, DC, United States of America.'}, {'ForeName': 'Bina', 'Initials': 'B', 'LastName': 'Valsangkar', 'Affiliation': 'Department of Global Health, Save the Children US, Washington, DC, United States of America.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Lwesha', 'Affiliation': 'Save the Children, Lilongwe, Malawi.'}, {'ForeName': 'Gedesi', 'Initials': 'G', 'LastName': 'Banda', 'Affiliation': 'Save the Children, Lilongwe, Malawi.'}, {'ForeName': 'Marte', 'Initials': 'M', 'LastName': 'Bøe Wensaas', 'Affiliation': 'Save the Children, Olso, Norway.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Luhanga', 'Affiliation': 'Save the Children, Lilongwe, Malawi.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Chimtembo', 'Affiliation': 'Save the Children, Lilongwe, Malawi.'}, {'ForeName': 'Mary V', 'Initials': 'MV', 'LastName': 'Kinney', 'Affiliation': 'Department of Global Health, Save the Children US, Washington, DC, United States of America.'}, {'ForeName': 'Queen', 'Initials': 'Q', 'LastName': 'Dube', 'Affiliation': 'College of Medicine, University of Malawi, Blantyre, Malawi.'}]",PloS one,['10.1371/journal.pone.0229720']
788,32191755,Static stretch and dynamic muscle activity induce acute similar increase in corticospinal excitability.,"Even though the acute effects of pre-exercise static stretching and dynamic muscle activity on muscular and functional performance have been largely investigated, their effects on the corticospinal pathway are still unclear. For that reason, this study examined the acute effects of 5×20 s of static stretching, dynamic muscle activity and a control condition on spinal excitability, corticospinal excitability and plantar flexor neuromuscular properties. Fifteen volunteers were randomly tested on separate days. Transcranial magnetic stimulation was applied to investigate corticospinal excitability by recording the amplitude of the motor-evoked potential (MEP) and the duration of the cortical silent period (cSP). Peripheral nerve stimulation was applied to investigate (i) spinal excitability using the Hoffmann reflex (Hmax), and (ii) neuromuscular properties using the amplitude of the maximal M-wave (Mmax) and corresponding peak twitch torque. These measurements were performed with a background 30% of maximal voluntary isometric contraction. Finally, the maximal voluntary isometric contraction torque and the corresponding electromyography (EMG) from soleus, gastrocnemius medialis and gastrocnemius lateralis were recorded. These parameters were measured immediately before and 10 s after each conditioning activity of plantar flexors. Corticospinal excitability (MEP/Mmax) was significantly enhanced after static stretching in soleus (P = 0.001; ES = 0.54) and gastrocnemius lateralis (P<0.001; ES = 0.64), and after dynamic muscle activity in gastrocnemius lateralis (P = 0.003; ES = 0.53) only. On the other hand, spinal excitability (Hmax/Mmax), cSP duration, muscle activation (EMG/Mmax) as well as maximal voluntary and evoked torque remained unaltered after all pre-exercise interventions. These findings indicate the presence of facilitation of the corticospinal pathway without change in muscle function after both static stretching (particularly) and dynamic muscle activity.",2020,"Corticospinal excitability (MEP/Mmax) was significantly enhanced after static stretching in soleus (P = 0.001; ES = 0.54) and gastrocnemius lateralis (P<0.001; ES = 0.64), and after dynamic muscle activity in gastrocnemius lateralis (P = 0.003; ES = 0.53) only.",['Fifteen volunteers'],['Transcranial magnetic stimulation'],"['spinal excitability (Hmax/Mmax), cSP duration, muscle activation (EMG/Mmax', 'Corticospinal excitability (MEP/Mmax', 'maximal voluntary isometric contraction torque and the corresponding electromyography (EMG) from soleus, gastrocnemius medialis and gastrocnemius lateralis', 'corticospinal excitability', 'maximal voluntary and evoked torque', 'spinal excitability, corticospinal excitability and plantar flexor neuromuscular properties']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}]","[{'cui': 'C0235169', 'cui_str': 'Excitability (finding)'}, {'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0022205', 'cui_str': 'Isometric Contraction'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0442036', 'cui_str': 'Plantar (qualifier value)'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}]",15.0,0.0176055,"Corticospinal excitability (MEP/Mmax) was significantly enhanced after static stretching in soleus (P = 0.001; ES = 0.54) and gastrocnemius lateralis (P<0.001; ES = 0.64), and after dynamic muscle activity in gastrocnemius lateralis (P = 0.003; ES = 0.53) only.","[{'ForeName': 'Jules', 'Initials': 'J', 'LastName': 'Opplert', 'Affiliation': 'INSERM UMR1093-CAPS, University of Burgundy Franche-Comté, Faculty of Sport Sciences, Dijon, France.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Paizis', 'Affiliation': 'INSERM UMR1093-CAPS, University of Burgundy Franche-Comté, Faculty of Sport Sciences, Dijon, France.'}, {'ForeName': 'Athina', 'Initials': 'A', 'LastName': 'Papitsa', 'Affiliation': 'INSERM UMR1093-CAPS, University of Burgundy Franche-Comté, Faculty of Sport Sciences, Dijon, France.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Blazevich', 'Affiliation': 'School of Medical and Health Sciences and Centre for Exercise and Sports Science Research, Edith Cowan University, Perth, Australia.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Cometti', 'Affiliation': 'INSERM UMR1093-CAPS, University of Burgundy Franche-Comté, Faculty of Sport Sciences, Dijon, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Babault', 'Affiliation': 'INSERM UMR1093-CAPS, University of Burgundy Franche-Comté, Faculty of Sport Sciences, Dijon, France.'}]",PloS one,['10.1371/journal.pone.0230388']
789,31955642,Paramedic Global Impression of Change During Prehospital Evaluation and Transport for Acute Stroke.,"Background and Purpose- The prehospital setting is a promising site for therapeutic intervention in stroke, but current stroke screening tools do not account for the evolution of neurological symptoms in this early period. We developed and validated the Paramedic Global Impression of Change (PGIC) Scale in a large, prospective, randomized trial. Methods- In the prehospital FAST-MAG (Field Administration of Stroke Therapy-Magnesium) randomized trial conducted from 2005 to 2013, EMS providers were asked to complete the PGIC Scale (5-point Likert scale values: 1-much improved, 2-mildly improved, 3-unchanged, 4-mildly worsened, 5-much worsened) for neurological symptom change during transport for consecutive patients transported by ambulance within 2 hours of onset. We analyzed PGIC concurrent validity (compared with change in Glasgow Coma Scale, Los Angeles Motor Scale), convergent validity (compared with National Institutes of Health Stroke Scale severity measure performed in the emergency department), and predictive validity (of neurological deterioration after hospital arrival and of final 90-day functional outcome). We used PGIC to characterize differential prehospital course among stroke subtypes. Results- Paramedics completed the PGIC in 1691 of 1700 subjects (99.5%), among whom 635 (37.5%) had neurological deficit evolution (32% improvement, 5.5% worsening) during a median prehospital care period of 33 (IQR, 27-39) minutes. Improvement was associated with diagnosis of cerebral ischemia rather than intracranial hemorrhage, milder stroke deficits on emergency department arrival, and more frequent nondisabled and independent 3-month outcomes. Conversely, worsening on the PGIC was associated with intracranial hemorrhage, more severe neurological deficits on emergency department arrival, more frequent treatment with thrombolytic therapy, and poor disability outcome at 3 months. Conclusions- The PGIC scale is a simple, validated measure of prehospital patient course that has the potential to provide information useful to emergency department decision-making. Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT00059332.",2020,"Conversely, worsening on the PGIC was associated with intracranial hemorrhage, more severe neurological deficits on emergency department arrival, more frequent treatment with thrombolytic therapy, and poor disability outcome at 3 months.",[],"[' and Purpose', 'Methods', 'Conclusions']","['PGIC Scale (5-point Likert scale values: 1-much improved, 2-mildly improved, 3-unchanged, 4-mildly worsened, 5-much worsened) for neurological symptom change', 'Paramedic Global Impression of Change (PGIC', 'Glasgow Coma Scale, Los Angeles Motor Scale), convergent validity', 'severe neurological deficits', 'diagnosis of cerebral ischemia rather than intracranial hemorrhage, milder stroke deficits', 'neurological deficit evolution']",[],"[{'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0222045'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0442739', 'cui_str': 'Id status quo'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0421226', 'cui_str': 'Neurological symptom changes (finding)'}, {'cui': 'C0030450', 'cui_str': 'Paramedics'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale (assessment scale)'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0521654', 'cui_str': 'Neurologic Deficits'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0917798', 'cui_str': 'Cerebral Ischemia'}, {'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]",1700.0,0.0547888,"Conversely, worsening on the PGIC was associated with intracranial hemorrhage, more severe neurological deficits on emergency department arrival, more frequent treatment with thrombolytic therapy, and poor disability outcome at 3 months.","[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Shkirkova', 'Affiliation': 'From the Keck School of Medicine (K.S., E.B., N.S.), University of Southern California, Los Angeles.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Schuberg', 'Affiliation': 'Department of Emergency Medicine (S. Schuberg, M.E.), University of Southern California, Los Angeles.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Balouzian', 'Affiliation': 'From the Keck School of Medicine (K.S., E.B., N.S.), University of Southern California, Los Angeles.'}, {'ForeName': 'Sidney', 'Initials': 'S', 'LastName': 'Starkman', 'Affiliation': 'Comprehensive Stroke Center (S. Starkman, L.S., D.S.L., J.L.S.), University of California Los Angeles.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Eckstein', 'Affiliation': 'Department of Emergency Medicine (S. Schuberg, M.E.), University of Southern California, Los Angeles.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Stratton', 'Affiliation': 'Department of Emergency Medicine (S. Starkman, S. Stratton), University of California Los Angeles.'}, {'ForeName': 'Franklin D', 'Initials': 'FD', 'LastName': 'Pratt', 'Affiliation': 'Los Angeles County Fire Department, CA (F.D.P.).'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Hamilton', 'Affiliation': 'School of Public Health (S.H.), University of California Los Angeles.'}, {'ForeName': 'Latisha', 'Initials': 'L', 'LastName': 'Sharma', 'Affiliation': 'Comprehensive Stroke Center (S. Starkman, L.S., D.S.L., J.L.S.), University of California Los Angeles.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Liebeskind', 'Affiliation': 'Comprehensive Stroke Center (S. Starkman, L.S., D.S.L., J.L.S.), University of California Los Angeles.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Conwit', 'Affiliation': 'National Institute of Neurological Disorders and Stroke (R.C.).'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Saver', 'Affiliation': 'Comprehensive Stroke Center (S. Starkman, L.S., D.S.L., J.L.S.), University of California Los Angeles.'}, {'ForeName': 'Nerses', 'Initials': 'N', 'LastName': 'Sanossian', 'Affiliation': 'From the Keck School of Medicine (K.S., E.B., N.S.), University of Southern California, Los Angeles.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.119.026392']
790,31974142,PPARA  Polymorphism Influences the Cardiovascular Benefit of Fenofibrate in Type 2 Diabetes: Findings From ACCORD-Lipid.,"The cardiovascular benefits of fibrates have been shown to be heterogeneous and to depend on the presence of atherogenic dyslipidemia. We investigated whether genetic variability in the  PPARA  gene, coding for the pharmacological target of fibrates (PPAR-α), could be used to improve the selection of patients with type 2 diabetes who may derive cardiovascular benefit from addition of this treatment to statins. We identified a common variant at the  PPARA  locus (rs6008845, C/T) displaying a study-wide significant influence on the effect of fenofibrate on major cardiovascular events (MACE) among 3,065 self-reported white subjects treated with simvastatin and randomized to fenofibrate or placebo in the ACCORD-Lipid trial. T/T homozygotes (36% of participants) experienced a 51% MACE reduction in response to fenofibrate (hazard ratio 0.49; 95% CI 0.34-0.72), whereas no benefit was observed for other genotypes ( P   interaction  = 3.7 × 10 -4 ). The rs6008845-by-fenofibrate interaction on MACE was replicated in African Americans from ACCORD ( N  = 585,  P  = 0.02) and in external cohorts (ACCORD-BP, ORIGIN, and TRIUMPH, total  N  = 3059,  P  = 0.005). Remarkably, rs6008845 T/T homozygotes experienced a cardiovascular benefit from fibrate even in the absence of atherogenic dyslipidemia. Among these individuals, but not among carriers of other genotypes, fenofibrate treatment was associated with lower circulating levels of CCL11-a proinflammatory and atherogenic chemokine also known as eotaxin ( P  for rs6008845-by-fenofibrate interaction = 0.003). The GTEx data set revealed regulatory functions of rs6008845 on  PPARA  expression in many tissues. In summary, we have found a common  PPARA  regulatory variant that influences the cardiovascular effects of fenofibrate and that could be used to identify patients with type 2 diabetes who would derive benefit from fenofibrate treatment, in addition to those with atherogenic dyslipidemia.",2020,T/T homozygotes (36% of participants) experienced a 51% MACE reduction in response to fenofibrate (HR=0.49; 95%C.I. 0.34-0.72) whereas no benefit was observed for other genotypes (p for interaction=3.7x10 -4 ).,"['Type 2 Diabetes', '3,065 self-reported White subjects treated with', 'patients with type 2 diabetes']","['Fenofibrate', 'simvastatin', 'fenofibrate', 'fenofibrate or placebo']","['circulating levels of CCL11 - a pro-inflammatory and atherogenic chemokine', 'major cardiovascular events (MACE']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0033228', 'cui_str': 'Fenofibrate'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}]",,0.0503884,T/T homozygotes (36% of participants) experienced a 51% MACE reduction in response to fenofibrate (HR=0.49; 95%C.I. 0.34-0.72) whereas no benefit was observed for other genotypes (p for interaction=3.7x10 -4 ).,"[{'ForeName': 'Mario Luca', 'Initials': 'ML', 'LastName': 'Morieri', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA.'}, {'ForeName': 'Hetal S', 'Initials': 'HS', 'LastName': 'Shah', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Sjaarda', 'Affiliation': 'McMaster University and Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Petra A', 'Initials': 'PA', 'LastName': 'Lenzini', 'Affiliation': 'Department of Genetics, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Campbell', 'Affiliation': 'Department of Genetics, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Alison A', 'Initials': 'AA', 'LastName': 'Motsinger-Reif', 'Affiliation': 'Biostatistics and Computational Biology Branch, National Institute of Environmental Health Sciences, Durham, NC.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Gao', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lovato', 'Affiliation': 'Wake Forest School of Medicine, Winston Salem, NC.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Prudente', 'Affiliation': 'Research Unit of Metabolic and Cardiovascular Diseases, Fondazione IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Assunta', 'Initials': 'A', 'LastName': 'Pandolfi', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, University ""G. d\'Annunzio,"" Chieti, Italy.'}, {'ForeName': 'Marcus G', 'Initials': 'MG', 'LastName': 'Pezzolesi', 'Affiliation': 'Division of Nephrology and Hypertension and Diabetes and Metabolism Center, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Sigal', 'Affiliation': 'Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Cumming School of Medicine, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Paré', 'Affiliation': 'McMaster University and Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Santica M', 'Initials': 'SM', 'LastName': 'Marcovina', 'Affiliation': 'Department of Medicine, University of Washington, and Northwest Lipid Metabolism and Diabetes Research Laboratories, Seattle, WA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Rotroff', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Patorno', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Mercuri', 'Affiliation': 'Research Unit of Metabolic and Cardiovascular Diseases, Fondazione IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Trischitta', 'Affiliation': 'Research Unit of Metabolic and Cardiovascular Diseases, Fondazione IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Emily Y', 'Initials': 'EY', 'LastName': 'Chew', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kraft', 'Affiliation': 'Departments of Epidemiology and Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Wagner', 'Affiliation': 'Center for Pharmacogenomics and Individualized Therapy, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Cresci', 'Affiliation': 'Department of Genetics, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Hertzel C', 'Initials': 'HC', 'LastName': 'Gerstein', 'Affiliation': 'McMaster University and Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Henry N', 'Initials': 'HN', 'LastName': 'Ginsberg', 'Affiliation': 'Irving Institute for Clinical and Translational Research, Vagelos College of Physicians and Surgeons, Columbia University, New York, NY.'}, {'ForeName': 'Josyf C', 'Initials': 'JC', 'LastName': 'Mychaleckyj', 'Affiliation': 'Center for Public Health Genomics, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Doria', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA alessandro.doria@joslin.harvard.edu.'}]",Diabetes,['10.2337/db19-0973']
791,30906944,"A Phase I Randomized Clinical Trial of Evidence-Based, Pragmatic Interventions to Improve Functional Recovery After Hospitalization in Geriatric Patients.","BACKGROUND


Physical function declines during hospitalization in geriatric patients, increasing the risk of loss of independence. There is a need for evidence-based, pragmatic interventions to improve functional recovery of older adults following acute hospitalization. Here, we report the results of a Phase I randomized clinical trial designed to determine safety and effect size of protein supplementation, exercise, and testosterone interventions on 30-day post-discharge functional recovery and readmissions in geriatric patients.
METHODS


A total of 100 patients admitted to the University of Texas Medical Branch hospital for an acute medical illness were randomized to one of five intervention groups: isocaloric placebo, whey protein supplement, in-home rehabilitation + placebo, in-home rehabilitation + whey protein, or testosterone. Primary outcome measure was the change from baseline in short physical performance battery score at 1 and 4 weeks post-discharge. Secondary outcomes were changes in body composition, activities of daily living, and 30-day readmissions. Comparisons were made across study groups and between placebo and all active intervention groups.
RESULTS


Four weeks post-discharge, the short physical performance battery total score and balance score increased more in active intervention groups than placebo group (p < .05). There were no significant differences in change in body composition or activities of daily living across groups or between active intervention groups and placebo group. Readmission rates were highest in placebo (28%), followed by rehabilitation + placebo (15%), whey protein (12%), rehabilitation + whey protein (11%), and testosterone (5%). There was a trend for lower readmission rates in all active intervention groups (11%) versus placebo group (28%).
CONCLUSIONS


Findings from this Phase I clinical trial suggest that pragmatic, evidence-based interventions may accelerate recovery from acute hospitalization in geriatric patients. These data provide essential information to design larger randomized controlled trials to test the effectiveness of these interventions.",2019,"Four weeks post-discharge the SPPB total score, and balance score increased more in AIG than placebo (P<0.05).","['Geriatric Patients', '100 patients admitted to the UTMB hospital for an acute medical illness', 'geriatric patients', 'older adults following acute hospitalization']","['isocaloric placebo, whey protein supplement, in-home rehabilitation+placebo, rehabilitation+whey protein, or testosterone', 'placebo', 'protein supplementation, exercise, and testosterone interventions']","['Functional Recovery', 'changes in body composition, activities of daily living, and 30-day readmissions', 'change from baseline in Short Physical Performance Battery (SPPB) score', 'Readmission rates', 'body composition or activities of daily living', 'SPPB total score, and balance score', 'lower readmission rates']","[{'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0770246', 'cui_str': 'Protein supplement'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C4075289', 'cui_str': 'Short Physical Performance Battery score (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",100.0,0.43346,"Four weeks post-discharge the SPPB total score, and balance score increased more in AIG than placebo (P<0.05).","[{'ForeName': 'Rachel R', 'Initials': 'RR', 'LastName': 'Deer', 'Affiliation': 'Sealy Center on Aging, The University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Dickinson', 'Affiliation': 'Sealy Center on Aging, The University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Baillargeon', 'Affiliation': 'Department of Preventive Medicine and Community Health, The University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Fisher', 'Affiliation': 'Sealy Center on Aging, The University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Mukaila', 'Initials': 'M', 'LastName': 'Raji', 'Affiliation': 'Sealy Center on Aging, The University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Volpi', 'Affiliation': 'Sealy Center on Aging, The University of Texas Medical Branch, Galveston.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glz084']
792,30913305,Validation of NRG oncology/RTOG-0129 risk groups for HPV-positive and HPV-negative oropharyngeal squamous cell cancer: Implications for risk-based therapeutic intensity trials.,"BACKGROUND


Radiation Therapy Oncology Group (RTOG)-0129 recursive partitioning analysis was the basis for risk-based therapeutic intensification trials for oropharyngeal cancer (OPC). To the authors' knowledge, the question of whether RTOG-0129 overall survival (OS) estimates for low-risk, intermediate-risk, and high-risk groups are similar in other data sets or applicable to progression-free survival (PFS) is unknown. Therefore, the authors evaluated whether survival differences between RTOG-0129 risk groups persist at 5 years, are reproducible in an independent clinical trial, and are applicable to PFS, and whether toxicities differ across risk groups.
METHODS


Prospective randomized clinical trials were analyzed retrospectively. RTOG-0129 evaluated standard versus accelerated fractionation radiotherapy concurrent with cisplatin. RTOG-0522 compared the combination of cisplatin and accelerated fractionation with or without cetuximab. Patients with OPC with available p16 status and tobacco history were eligible.
RESULTS


There was a total of 260 patients and 287 patients, respectively, from RTOG-0129 and RTOG-0522, with median follow-ups for surviving patients of 7.9 years (range, 1.7-9.9 years) and 4.7 years (range, 0.1-7.0 years), respectively. Previous OS differences in RTOG-0129 persisted at 5 years. In RTOG-0522, the 5-year OS rates for the low-risk, intermediate-risk, and high-risk groups were 88.1%, 69.9%, and 45.1%, respectively (P for trend, <.001). The 5-year PFS rates for the same 3 groups were 72.9%, 56.1%, and 42.2%, respectively. In RTOG-0522 among a subgroup of patients considered to be at very good risk (p16-positive disease, smoking history of ≤10 pack-years, and classified with T1-T2 disease with ipsilateral lymph nodes measuring ≤6 cm or T3 disease without contralateral or >6 cm lymph nodes), the 5-year OS and PFS rates were 93.8% and 82.2%, respectively. Overall rates of acute and late toxicities were similar by risk group.
CONCLUSIONS


RTOG-0129 risk groups persisted at 5 years and were reproducible in RTOG-0522. However, there was variability in the estimates. These data underscore the importance of long-term follow-up and appropriate patient selection in therapeutic deintensification trials.",2019,"The 5-year PFS rates for the same 3 groups were 72.9%, 56.1%, and 42.2%, respectively.","['260 patients and 287 patients, respectively, from RTOG-0129 and RTOG-0522, with median follow-ups for surviving patients of 7.9\xa0years (range, 1.7-9.9\xa0years) and 4.7\xa0years (range, 0.1-7.0\xa0years), respectively', 'Patients with OPC with available p16 status and tobacco history were eligible', 'HPV-positive and HPV-negative oropharyngeal squamous cell cancer']","['cisplatin and accelerated fractionation with or without cetuximab', 'RTOG-0129 evaluated standard versus accelerated fractionation radiotherapy concurrent with cisplatin']","['5-year PFS rates', '5-year OS rates', '5-year OS and PFS rates', 'Overall rates of acute and late toxicities']","[{'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517682', 'cui_str': '287 (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517512', 'cui_str': '1.7 (qualifier value)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0249880', 'cui_str': 'Cyclin-Dependent Kinase Inhibitor p16'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C0751688', 'cui_str': 'Squamous Cell Cancer'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0521110', 'cui_str': 'Accelerated (contextual qualifier) (qualifier value)'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",260.0,0.0868149,"The 5-year PFS rates for the same 3 groups were 72.9%, 56.1%, and 42.2%, respectively.","[{'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Fakhry', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins University, School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, American College of Radiology, Philadelphia, Pennsylvania.'}, {'ForeName': 'Maura L', 'Initials': 'ML', 'LastName': 'Gillison', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Phuc Felix', 'Initials': 'PF', 'LastName': 'Nguyen-Tân', 'Affiliation': 'University Hospital of Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Rosenthal', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Randal S', 'Initials': 'RS', 'LastName': 'Weber', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Lambert', 'Affiliation': 'University Hospital of Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Andy M', 'Initials': 'AM', 'LastName': 'Trotti', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.'}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Barrett', 'Affiliation': 'University of Cincinnati Cancer Institute, Cincinnati, Ohio.'}, {'ForeName': 'Wade L', 'Initials': 'WL', 'LastName': 'Thorstad', 'Affiliation': 'Washington University, St. Louis, Missouri.'}, {'ForeName': 'Sue S', 'Initials': 'SS', 'LastName': 'Yom', 'Affiliation': 'University of California at San Francisco, San Francisco, California.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Wong', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Ridge', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Shyam S D', 'Initials': 'SSD', 'LastName': 'Rao', 'Affiliation': 'University of California at Davis, Davis, California.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Spencer', 'Affiliation': 'University of Alabama at Birmingham Medical Center, Birmingham, Alabama.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Fortin', 'Affiliation': ""L'Hotel-Dieu de Quebec, Quebec City, Quebec, Canada.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Raben', 'Affiliation': 'University of Colorado, Aurora, Colorado.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Harris', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, American College of Radiology, Philadelphia, Pennsylvania.'}, {'ForeName': 'Quynh-Thu', 'Initials': 'QT', 'LastName': 'Le', 'Affiliation': 'Stanford University, Stanford, California.'}]",Cancer,['10.1002/cncr.32025']
793,32403345,Listening to Preferred Music Improved Running Performance without Changing the Pacing Pattern during a 6 Minute Run Test with Young Male Adults.,"Several studies have investigated the effects of music on both submaximal and maximal exercise performance at a constant work-rate. However, there is a lack of research that has examined the effects of music on the pacing strategy during self-paced exercise. The aim of this study was to examine the effects of preferred music on performance and pacing during a 6 min run test (6-MSPRT) in young male adults. Twenty healthy male participants volunteered for this study. They performed two randomly assigned trials (with or without music) of a 6-MSPRT three days apart. Mean running speed, the adopted pacing strategy, total distance covered (TDC), peak and mean heart rate (HRpeak, HRmean), blood lactate (3 min after the test), and rate of perceived exertion (RPE) were measured. Listening to preferred music during the 6-MSPRT resulted in significant TDC improvement (Δ10%;  p =  0.016; effect size (ES) = 0.80). A significantly faster mean running speed was observed when listening to music compared with no music. The improvement of TDC in the present study is explained by a significant overall increase in speed (main effect for conditions) during the music trial. Music failed to modify pacing patterns as suggested by the similar reversed ""J-shaped"" profile during the two conditions. Blood-lactate concentrations were significantly reduced by 9% ( p  = 0.006, ES = 1.09) after the 6-MSPRT with music compared to those in the control condition. No statistically significant differences were found between the test conditions for HRpeak, HRmean, and RPE. Therefore, listening to preferred music can have positive effects on exercise performance during the 6-MSPRT, such as greater TDC, faster running speeds, and reduced blood lactate levels but has no effect on the pacing strategy.",2020,"Blood-lactate concentrations were significantly reduced by 9% ( p  = 0.006, ES = 1.09) after the 6-MSPRT with music compared to those in the control condition.","['Twenty healthy male participants volunteered for this study', 'young male adults', 'Young Male Adults']","['preferred music on performance and pacing during a 6 min run test (6-MSPRT', 'Listening to Preferred Music Improved Running Performance without Changing the Pacing Pattern']","['TDC improvement', 'Blood-lactate concentrations', 'HRpeak, HRmean, and RPE', 'mean running speed', 'blood lactate levels', 'Mean running speed, the adopted pacing strategy, total distance covered (TDC), peak and mean heart rate (HRpeak, HRmean), blood lactate (3 min after the test), and rate of perceived exertion (RPE', 'exercise performance']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}, {'cui': 'C0425382', 'cui_str': 'Adopted'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",20.0,0.116964,"Blood-lactate concentrations were significantly reduced by 9% ( p  = 0.006, ES = 1.09) after the 6-MSPRT with music compared to those in the control condition.","[{'ForeName': 'Nidhal', 'Initials': 'N', 'LastName': 'Jebabli', 'Affiliation': 'Health and Movement (2SHM) Laboratory, Sport Sciences, High Institute of Sport and Physical Education of Kef, University of Jendouba, le Kef 7001, Tunisia.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Granacher', 'Affiliation': 'Division of Training and Movement Sciences, University of Potsdam, 14469 Potsdam, Germany.'}, {'ForeName': 'Mohamed Amin', 'Initials': 'MA', 'LastName': 'Selmi', 'Affiliation': 'Tunisian Research Laboratory ""Sport Performance Optimization"", National Center of Medicine and Science in Sports (CNMSS), Tunis 1003, Tunisia.'}, {'ForeName': 'Badriya', 'Initials': 'B', 'LastName': 'Al-Haddabi', 'Affiliation': 'Physical Education Department, College of Education, Sultan Qaboos University, Muscat 123, Oman.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Behm', 'Affiliation': ""School of Human Kinetics and Recreation, Memorial University of Newfoundland, St. John's, NL A1C 5S7, Canada.""}, {'ForeName': 'Anis', 'Initials': 'A', 'LastName': 'Chaouachi', 'Affiliation': 'Tunisian Research Laboratory ""Sport Performance Optimization"", National Center of Medicine and Science in Sports (CNMSS), Tunis 1003, Tunisia.'}, {'ForeName': 'Radhouane Haj', 'Initials': 'RH', 'LastName': 'Sassi', 'Affiliation': 'Physical Education Department, College of Education, Sultan Qaboos University, Muscat 123, Oman.'}]","Sports (Basel, Switzerland)",['10.3390/sports8050061']
794,32403367,The Impact of Glucose-Based or Lipid-Based Total Parenteral Nutrition on the Free Fatty Acids Profile in Critically Ill Patients.,"INTRODUCTION


Our study aim was to assess how the macronutrient intake during total parenteral nutrition (TPN) modulates plasma total free fatty acids (FFAs) levels and individual fatty acids in critically ill patients.
METHOD


Adult patients aged 18-80, admitted to the intensive care unit (ICU), who were indicated for TPN, with an expected duration of more than three days, were included in the study. Isoenergetic and isonitrogenous TPN solutions were given with a major non-protein energy source, which was glucose (group G) or glucose and lipid emulsions (Smof lipid; group L). Blood samples were collected on days 0, 1, 3, 6, 9, 14, and 28.
RESULTS


A significant decrease ( p  < 0.001) in total FFAs occurred in both groups with a bigger decrease in group G ( p  < 0.001) from day 0 (0.41 ± 0.19 mmol∙L -1 ) to day 28 (0.10 ± 0.07 mmol∙L -1 ). Increased palmitooleic acid and decreased linoleic and docosahexaenoic acids, with a trend of increased mead acid to arachidonic acid ratio, on day 28 were observed in group G in comparison with group L. Group G had an insignificant increase in leptin with no differences in the concentrations of vitamin E, triacylglycerides, and plasminogen activator inhibitor-1.
CONCLUSION


Decreased plasma FFA in critically ill patients who receive TPN may result from increased insulin sensitivity with a better effect in group G, owing to higher insulin and glucose dosing and no lipid emulsions. It is advisable to include a lipid emulsion at the latest from three weeks of TPN to prevent essential fatty acid deficiency.",2020,A significant decrease ( p  < 0.001) in total FFAs occurred in both groups with a bigger decrease in group G ( p  < 0.001) from day 0 (0.41 ± 0.19 mmol∙L -1 ) to day 28 (0.10 ± 0.07 mmol∙L -1 ).,"['Critically Ill Patients', 'critically ill patients', 'critically ill patients who receive', 'Adult patients aged 18-80, admitted to the intensive care unit (ICU), who were indicated for TPN, with an expected duration of more than three days, were included in the study']","['Isoenergetic and isonitrogenous TPN solutions', 'Glucose-Based or Lipid-Based Total Parenteral Nutrition', 'TPN', 'glucose and lipid emulsions (Smof lipid', 'total parenteral nutrition (TPN']","['plasma total free fatty acids (FFAs) levels and individual fatty acids', 'mead acid to arachidonic acid ratio', 'leptin', 'plasma FFA', 'total FFAs', 'Blood samples', 'insulin sensitivity', 'concentrations of vitamin E, triacylglycerides, and plasminogen activator inhibitor-1', 'Increased palmitooleic acid and decreased linoleic and docosahexaenoic acids']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0030548', 'cui_str': 'Total parenteral nutrition'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0030548', 'cui_str': 'Total parenteral nutrition'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0014020', 'cui_str': 'Emulsions'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0048945', 'cui_str': '5,8,11-eicosatrienoic acid'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0030190', 'cui_str': 'Plasminogen activator inhibitor-1'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}]",,0.0386029,A significant decrease ( p  < 0.001) in total FFAs occurred in both groups with a bigger decrease in group G ( p  < 0.001) from day 0 (0.41 ± 0.19 mmol∙L -1 ) to day 28 (0.10 ± 0.07 mmol∙L -1 ).,"[{'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Skorepa', 'Affiliation': 'Department of Military Internal Medicine and Military Hygiene, Faculty of Military Health Sciences, University of Defence in Brno, Trebesska 1575, 50001 Hradec Kralove, Czech Republic.'}, {'ForeName': 'Ondrej', 'Initials': 'O', 'LastName': 'Sobotka', 'Affiliation': '3rd Department of Internal Medicine-Metabolic Care and Gerontology, University Hospital and Faculty of Medicine in Hradec Kralove, Charles University in Prague, Sokolska 581, 50005 Hradec Kralove, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Vanek', 'Affiliation': 'Department of Military Internal Medicine and Military Hygiene, Faculty of Military Health Sciences, University of Defence in Brno, Trebesska 1575, 50001 Hradec Kralove, Czech Republic.'}, {'ForeName': 'Alena', 'Initials': 'A', 'LastName': 'Ticha', 'Affiliation': 'Department of Clinical Biochemistry and Diagnostics, University Hospital and Faculty of Medicine in Hradec Kralove, Charles University in Prague, Sokolska 581, 50005 Hradec Kralove, Czech Republic.'}, {'ForeName': 'Joao', 'Initials': 'J', 'LastName': 'Fortunato', 'Affiliation': '3rd Department of Internal Medicine-Metabolic Care and Gerontology, University Hospital and Faculty of Medicine in Hradec Kralove, Charles University in Prague, Sokolska 581, 50005 Hradec Kralove, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Manak', 'Affiliation': '3rd Department of Internal Medicine-Metabolic Care and Gerontology, University Hospital and Faculty of Medicine in Hradec Kralove, Charles University in Prague, Sokolska 581, 50005 Hradec Kralove, Czech Republic.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Blaha', 'Affiliation': '3rd Department of Internal Medicine-Metabolic Care and Gerontology, University Hospital and Faculty of Medicine in Hradec Kralove, Charles University in Prague, Sokolska 581, 50005 Hradec Kralove, Czech Republic.'}, {'ForeName': 'Jan M', 'Initials': 'JM', 'LastName': 'Horacek', 'Affiliation': 'Department of Military Internal Medicine and Military Hygiene, Faculty of Military Health Sciences, University of Defence in Brno, Trebesska 1575, 50001 Hradec Kralove, Czech Republic.'}, {'ForeName': 'Lubos', 'Initials': 'L', 'LastName': 'Sobotka', 'Affiliation': '3rd Department of Internal Medicine-Metabolic Care and Gerontology, University Hospital and Faculty of Medicine in Hradec Kralove, Charles University in Prague, Sokolska 581, 50005 Hradec Kralove, Czech Republic.'}]",Nutrients,['10.3390/nu12051373']
795,24794367,Effect of fluconazole prophylaxis on candidiasis and mortality in premature infants: a randomized clinical trial.,"IMPORTANCE


Invasive candidiasis in premature infants causes death and neurodevelopmental impairment. Fluconazole prophylaxis reduces candidiasis, but its effect on mortality and the safety of fluconazole are unknown.
OBJECTIVE


To evaluate the efficacy and safety of fluconazole in preventing death or invasive candidiasis in extremely low-birth-weight infants.
DESIGN, SETTING, AND PATIENTS


This study was a randomized, blinded, placebo-controlled trial of fluconazole in premature infants. Infants weighing less than 750 g at birth (N = 361) from 32 neonatal intensive care units (NICUs) in the United States were randomly assigned to receive either fluconazole or placebo twice weekly for 42 days. Surviving infants were evaluated at 18 to 22 months corrected age for neurodevelopmental outcomes. The study was conducted between November 2008 and February 2013.
INTERVENTIONS


Fluconazole (6 mg/kg of body weight) or placebo.
MAIN OUTCOMES AND MEASURES


The primary end point was a composite of death or definite or probable invasive candidiasis prior to study day 49 (1 week after completion of study drug). Secondary and safety outcomes included invasive candidiasis, liver function, bacterial infection, length of stay, intracranial hemorrhage, periventricular leukomalacia, chronic lung disease, patent ductus arteriosus requiring surgery, retinopathy of prematurity requiring surgery, necrotizing enterocolitis, spontaneous intestinal perforation, and neurodevelopmental outcomes-defined as a Bayley-III cognition composite score of less than 70, blindness, deafness, or cerebral palsy at 18 to 22 months corrected age.
RESULTS


Among infants receiving fluconazole, the composite primary end point of death or invasive candidiasis was 16% (95% CI, 11%-22%) vs 21% in the placebo group (95% CI, 15%-28%; odds ratio, 0.73 [95% CI, 0.43-1.23]; P = .24; treatment difference, -5% [95% CI, -13% to 3%]). Invasive candidiasis occurred less frequently in the fluconazole group (3% [95% CI, 1%-6%]) vs the placebo group (9% [95% CI, 5%-14%]; P = .02; treatment difference, -6% [95% CI, -11% to -1%]). The cumulative incidences of other secondary outcomes were not statistically different between groups. Neurodevelopmental impairment did not differ between the groups (fluconazole, 31% [95% CI, 21%-41%] vs placebo, 27% [95% CI, 18%-37%]; P = .60; treatment difference, 4% [95% CI, -10% to 17%]).
CONCLUSIONS AND RELEVANCE


Among infants with a birth weight of less than 750 g, 42 days of fluconazole prophylaxis compared with placebo did not result in a lower incidence of the composite of death or invasive candidiasis. These findings do not support the universal use of prophylactic fluconazole in extremely low-birth-weight infants.
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT00734539.",2014,"Neurodevelopmental impairment did not differ between the groups (fluconazole, 31% [95% CI, 21%-41%] vs placebo, 27% [95% CI, 18%-37%]; P = .60; treatment difference, 4% [95% CI, -10% to 17%]).
","['Infants weighing less than 750 g at birth (N\u2009=\u2009361) from 32 neonatal intensive care units (NICUs) in the United States', 'extremely low-birth-weight infants', 'infants with a birth weight of less than 750 g, 42 days of', 'premature infants', 'November 2008 and February 2013']","['placebo', 'fluconazole or placebo', 'fluconazole', 'prophylactic fluconazole', 'Fluconazole prophylaxis', 'fluconazole prophylaxis', 'Fluconazole']","['cumulative incidences', 'invasive candidiasis, liver function, bacterial infection, length of stay, intracranial hemorrhage, periventricular leukomalacia, chronic lung disease, patent ductus arteriosus requiring surgery, retinopathy of prematurity requiring surgery, necrotizing enterocolitis, spontaneous intestinal perforation, and neurodevelopmental outcomes-defined as a Bayley-III cognition composite score of less than 70, blindness, deafness, or cerebral palsy', 'composite of death or definite or probable invasive candidiasis', 'Invasive candidiasis', 'efficacy and safety', 'candidiasis and mortality', 'Neurodevelopmental impairment', 'composite of death or invasive candidiasis', 'death or invasive candidiasis']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0456065', 'cui_str': 'Infant, Extremely Low Birth Weight'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0004623', 'cui_str': 'Bacterial Infections'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}, {'cui': 'C0023529', 'cui_str': 'Encephalomalacia, Periventricular'}, {'cui': 'C0746102', 'cui_str': 'Chronic lung disease'}, {'cui': 'C3495549', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0035344', 'cui_str': 'Retrolental Fibroplasia'}, {'cui': 'C0520459', 'cui_str': 'Necrotizing Enterocolitis'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0021845', 'cui_str': 'Intestinal Perforation'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]",,0.60973,"Neurodevelopmental impairment did not differ between the groups (fluconazole, 31% [95% CI, 21%-41%] vs placebo, 27% [95% CI, 18%-37%]; P = .60; treatment difference, 4% [95% CI, -10% to 17%]).
","[{'ForeName': 'Daniel K', 'Initials': 'DK', 'LastName': 'Benjamin', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Hudak', 'Affiliation': 'University of Florida College of Medicine-Jacksonville.'}, {'ForeName': 'Shahnaz', 'Initials': 'S', 'LastName': 'Duara', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Randolph', 'Affiliation': 'University of Alabama-Birmingham.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Bidegain', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Gratias T', 'Initials': 'GT', 'LastName': 'Mundakel', 'Affiliation': 'Kings County Hospital, Brooklyn, New York.'}, {'ForeName': 'Girija', 'Initials': 'G', 'LastName': 'Natarajan', 'Affiliation': 'Wayne State University, Detroit, Michigan.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Burchfield', 'Affiliation': 'University of Florida Health Shands Hospital, Gainesville.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'White', 'Affiliation': 'Memorial Hospital South Bend, South Bend, Indiana.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Shattuck', 'Affiliation': 'University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Neu', 'Affiliation': 'Columbia University, New York, New York.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Bendel', 'Affiliation': ""University of Minnesota Amplatz Children's Hospital, Minneapolis.""}, {'ForeName': 'M Roger', 'Initials': 'MR', 'LastName': 'Kim', 'Affiliation': 'Brookdale University Hospital, Brooklyn, New York.'}, {'ForeName': 'Neil N', 'Initials': 'NN', 'LastName': 'Finer', 'Affiliation': 'University of California-San Diego Medical Center.'}, {'ForeName': 'Dan L', 'Initials': 'DL', 'LastName': 'Stewart', 'Affiliation': 'University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Arrieta', 'Affiliation': ""Children's Hospital of Orange County, Orange, California.""}, {'ForeName': 'Kelly C', 'Initials': 'KC', 'LastName': 'Wade', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kaufman', 'Affiliation': 'University of Virginia, Charlottesville.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Manzoni', 'Affiliation': ""Sant'Anna Hospital, Turin, Italy.""}, {'ForeName': 'Kristi O', 'Initials': 'KO', 'LastName': 'Prather', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Testoni', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Katherine Y', 'Initials': 'KY', 'LastName': 'Berezny', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'P Brian', 'Initials': 'PB', 'LastName': 'Smith', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2014.2624']
796,32187115,Factors Associated With Cannabis Use Among African American Nondaily Smokers.,"OBJECTIVES


Cannabis and tobacco dual use is a growing concern in the United States, especially among African Americans (AAs). Dual use increases nicotine dependence and poses negative health effects. Despite decreasing numbers of people who smoke daily, nondaily smokers (NDS) are increasing. Polytobacco use, including blunt use, is higher in AA NDS than AAs who smoke daily. This study examined factors associated with cannabis use among AA NDS.
METHODS


Adult AA NDS participated in a randomized controlled trial (n = 278) for smoking cessation. A subset of this sample (n = 262; mean age 48.2 years; 50% male) was analyzed to identify correlates of cannabis use. Logistic regression assessed the associations of demographic, smoking-related, and psychosocial variables with cannabis use.
RESULTS


Participants smoked cigarettes on an average of 18 days of the last 30 and used 4.5 cigarettes on smoking days. Of the participants analyzed, 38% used cannabis, including blunts (ie, cigars hollowed out filled with cannabis) at baseline. Cannabis use was associated with polytobacco product use not including blunts (odds ratio [OR] 2.11, 95% confidence interval [CI] 1.18-3.77, P = 0.012), depressive symptoms (OR 1.22, 95% CI 1.05-1.42, P = 0.011), and younger age (OR 0.97, 95% CI 0.94-0.99, P = 0.004).
CONCLUSIONS


Rates of cannabis and tobacco dual use in our sample exceed national rates. Dual use poses harmful health effects that exceed the risk of either substance alone. Findings will inform future work in tailoring treatments to vulnerable groups of people who use both tobacco and cannabis.",2020,"Cannabis use was associated with polytobacco product use not including blunts (odds ratio [OR] 2.11, 95% confidence interval [CI] 1.18-3.77, P = 0.012), depressive symptoms (OR 1.22, 95% CI 1.05-1.42, P = 0.011), and younger age (OR 0.97, 95% CI 0.94-0.99, P = 0.004).
","['African Americans (AAs', 'African American Nondaily Smokers', 'Adult AA NDS participated in a randomized controlled trial (n\u200a=\u200a278) for smoking cessation', 'A subset of this sample (n\u200a=\u200a262; mean age 48.2 years; 50% male']",[],['depressive symptoms'],"[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0057753', 'cui_str': 'NDS'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]",[],"[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",,0.0939808,"Cannabis use was associated with polytobacco product use not including blunts (odds ratio [OR] 2.11, 95% confidence interval [CI] 1.18-3.77, P = 0.012), depressive symptoms (OR 1.22, 95% CI 1.05-1.42, P = 0.011), and younger age (OR 0.97, 95% CI 0.94-0.99, P = 0.004).
","[{'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Rubenstein', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, RI (DR, ERA, JSA); Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI (ERA, JSA); Department of Population Health, University of Kansas School of Medicine, Kansas City, KS (NLN); Department of Biostatistics & Data Science, University of Kansas School of Medicine, Kansas City, KS (MSM, ARB).'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Aston', 'Affiliation': ''}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Nollen', 'Affiliation': ''}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Mayo', 'Affiliation': ''}, {'ForeName': 'Alexandra R', 'Initials': 'AR', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Jasjit S', 'Initials': 'JS', 'LastName': 'Ahluwalia', 'Affiliation': ''}]",Journal of addiction medicine,['10.1097/ADM.0000000000000652']
797,32160926,"Effects of dietary methionine and cysteine restriction on plasma biomarkers, serum fibroblast growth factor 21, and adipose tissue gene expression in women with overweight or obesity: a double-blind randomized controlled pilot study.","BACKGROUND


Dietary restriction of methionine and cysteine is a well-described model that improves metabolic health in rodents. To investigate the translational potential in humans, we evaluated the effects of dietary methionine and cysteine restriction on cardiometabolic risk factors, plasma and urinary amino acid profile, serum fibroblast growth factor 21 (FGF21), and subcutaneous adipose tissue gene expression in women with overweight and obesity in a double-blind randomized controlled pilot study.
METHODS


Twenty women with overweight or obesity were allocated to a diet low (Met/Cys -low,  n = 7), medium (Met/Cys -medium,  n = 7) or high (Met/Cys -high,  n = 6) in methionine and cysteine for 7 days. The diets differed only by methionine and cysteine content. Blood and urine were collected at day 0, 1, 3 and 7 and subcutaneous adipose tissue biopsies were taken at day 0 and 7.
RESULTS


Plasma methionine and cystathionine and urinary total cysteine decreased, whereas FGF21 increased in the Met/Cys -low  vs. Met/Cys -high  group. The Met/Cys -low  group had increased mRNA expression of lipogenic genes in adipose tissue including DGAT1. When we excluded one participant with high fasting insulin at baseline, the Met/Cys -low  group showed increased expression of ACAC, DGAT1, and tendencies for increased expression of FASN and SCD1 compared to the Met/Cys -high  group. The participants reported satisfactory compliance and that the diets were moderately easy to follow.
CONCLUSIONS


Our data suggest that dietary methionine and cysteine restriction may have beneficial effects on circulating biomarkers, including FGF21, and influence subcutaneous adipose tissue gene expression. These results will aid in the design and implementation of future large-scale dietary interventions with methionine and cysteine restriction. Trial registration ClinicalTrials.gov Identifier: NCT03629392, registration date: 14/08/2018 https://clinicaltrials.gov/ct2/show/NCT03629392.",2020,The Met/Cys -low  group had increased mRNA expression of lipogenic genes in adipose tissue including DGAT1.,"['women with overweight and obesity', 'women with overweight or obesity', 'Twenty women with overweight or obesity']","['diet low (Met/Cys -low,  n\u2009=\u20097), medium (Met/Cys -medium,  n\u2009=\u20097) or high (Met/Cys -high,  n\u2009=\u20096) in methionine and cysteine', 'dietary methionine and cysteine restriction']","['Blood and urine', 'Plasma methionine and cystathionine and urinary total cysteine', 'cardiometabolic risk factors, plasma and urinary amino acid profile, serum fibroblast growth factor 21 (FGF21), and subcutaneous adipose tissue gene expression', 'plasma biomarkers, serum fibroblast growth factor 21, and adipose tissue gene expression', 'expression of ACAC, DGAT1, and tendencies for increased expression of FASN and SCD1', 'mRNA expression of lipogenic genes', 'FGF21']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0025646', 'cui_str': 'L-methionine'}, {'cui': 'C0010654', 'cui_str': 'L-cysteine'}]","[{'cui': 'C0005768'}, {'cui': 'C0042037'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0025646', 'cui_str': 'L-methionine'}, {'cui': 'C0010640', 'cui_str': 'L-Homocysteine, S-(2-amino-2-carboxyethyl)-, (R)-'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010654', 'cui_str': 'L-cysteine'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C0017337', 'cui_str': 'Genes'}]",20.0,0.0668849,The Met/Cys -low  group had increased mRNA expression of lipogenic genes in adipose tissue including DGAT1.,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Olsen', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Postboks 1046, Blindern, 0317, Oslo, Norway. thomas.olsen@medisin.uio.no.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Øvrebø', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Postboks 1046, Blindern, 0317, Oslo, Norway.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Haj-Yasein', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Postboks 1046, Blindern, 0317, Oslo, Norway.'}, {'ForeName': 'Sindre', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Postboks 1046, Blindern, 0317, Oslo, Norway.'}, {'ForeName': 'Karianne', 'Initials': 'K', 'LastName': 'Svendsen', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Postboks 1046, Blindern, 0317, Oslo, Norway.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Hjorth', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Postboks 1046, Blindern, 0317, Oslo, Norway.'}, {'ForeName': 'Nasser E', 'Initials': 'NE', 'LastName': 'Bastani', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Postboks 1046, Blindern, 0317, Oslo, Norway.'}, {'ForeName': 'Frode', 'Initials': 'F', 'LastName': 'Norheim', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Postboks 1046, Blindern, 0317, Oslo, Norway.'}, {'ForeName': 'Christian A', 'Initials': 'CA', 'LastName': 'Drevon', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Postboks 1046, Blindern, 0317, Oslo, Norway.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Refsum', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Postboks 1046, Blindern, 0317, Oslo, Norway.'}, {'ForeName': 'Kathrine J', 'Initials': 'KJ', 'LastName': 'Vinknes', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Postboks 1046, Blindern, 0317, Oslo, Norway.'}]",Journal of translational medicine,['10.1186/s12967-020-02288-x']
798,32185595,"A prospective randomized trial comparing corifollitropin-α late-start (day 4) versus standard administration (day 2) in expected poor, normal, and high responders undergoing controlled ovarian stimulation for IVF.","OBJECTIVE


To assess whether corifollitropin-α (CFα) late-start administration (day 4) and standard administration (day 2) can obtain similar oocyte yield and live birth rate.
STUDY DESIGN


A randomized controlled trial.
SETTING


University Hospital IVF Unit.
PATIENTS


One hundred thirteen women undergoing IVF.
INTERVENTIONS


Patients distributed in three subgroups (expected poor, normal, or high responders to FSH) were randomized into two treatment arms: (a) CFα late-start: CFα on day 4 + GnRH antagonist from day 8 + (when needed) recFSH from day 11; (b) CFα standard start: CFα on day 2 + GnRH antagonist from day 6 + (when needed) recFSH from day 9. IVF or ICSI was performed as indicated.
RESULTS


Considering the whole study group, the late-start regimen obtained comparable oocyte yield (8.9 ± 5.6 vs. 8.8 ± 6.2; p = n.s.), cPR/started cycle (25% vs. 31.6%, p = n.s.), and cumulative live birth rate (LBR)/ovum pickup (OPU) (29.2% vs. 37.7%, p = n.s.) than the standard regimen. The outcome of the two regimens was comparable in the two subgroups of high and normal responders. Differently, in poor responders, oocyte yield was similar, but LBR/OPU was significantly lower with late-start CFα administration that caused 40% cancellation rate due to monofollicular response. ROC curves showed that the threshold AMH levels associated with cycle cancellation were 0.6 ng/ml for late-start regimen and 0.2 ng/ml for standard regimen.
CONCLUSION


CFα may be administered on either day 2 or day 4 to patients with expected high or normal response to FSH without compromising oocyte yield and/or live birth rate. Differently, late-start administration is not advisable for expected poor responders with AMH ≤ 0.6 ng/ml.
TRIAL REGISTRATION


NCT03816670.",2020,The outcome of the two regimens was comparable in the two subgroups of high and normal responders.,"['One hundred thirteen women undergoing IVF', 'University Hospital IVF Unit']","['IVF or ICSI', 'corifollitropin-α late-start (day 4) versus standard administration', 'corifollitropin-α (CFα) late-start administration (day 4) and standard administration', 'CFα late-start: CFα on day 4 + GnRH antagonist from day 8 + (when needed) recFSH']","['oocyte yield', 'LBR/OPU', 'cumulative live birth rate (LBR)/ovum pickup (OPU', 'cPR/started cycle']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]","[{'cui': 'C0029045', 'cui_str': 'Ovocytes'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C1272689', 'cui_str': 'Started'}]",113.0,0.17166,The outcome of the two regimens was comparable in the two subgroups of high and normal responders.,"[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Revelli', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy. alberto.revelli@unito.it.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Gennarelli', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Sestero', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Canosa', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Carosso', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Salvagno', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Pittatore', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Filippini', 'Affiliation': 'Clinical Statistics, Department of Surgical Sciences, University of Torino, Corso Bramante 88, Turin, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Benedetto', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy.'}]",Journal of assisted reproduction and genetics,['10.1007/s10815-020-01742-5']
799,31915189,Effects of acute sleep loss on diurnal plasma dynamics of CNS health biomarkers in young men.,"OBJECTIVE


Disrupted sleep increases CSF levels of tau and β-amyloid (Aβ) and is associated with an increased risk of Alzheimer disease (AD). Our aim was to determine whether acute sleep loss alters diurnal profiles of plasma-based AD-associated biomarkers.
METHODS


In a 2-condition crossover study, 15 healthy young men participated in 2 standardized sedentary in-laboratory conditions in randomized order: normal sleep vs overnight sleep loss. Plasma levels of total tau (t-tau), Aβ40, Aβ42, neurofilament light chain (NfL), and glial fibrillary acidic protein (GFAP) were assessed using ultrasensitive single molecule array assays or ELISAs, in the fasted state in the evening prior to, and in the morning after, each intervention.
RESULTS


In response to sleep loss (+17.2%), compared with normal sleep (+1.8%), the evening to morning ratio was increased for t-tau ( p  = 0.035). No changes between the sleep conditions were seen for levels of Aβ40, Aβ42, NfL, or GFAP (all  p  > 0.10). The AD risk genotype rs4420638 did not significantly interact with sleep loss-related diurnal changes in plasma levels of Aβ40 or Aβ42 ( p  > 0.10). Plasma levels of Aβ42 (-17.1%) and GFAP (-12.1%) exhibited an evening to morning decrease across conditions ( p  < 0.05).
CONCLUSIONS


Our exploratory study suggests that acute sleep loss results in increased blood levels of t-tau. These changes provide further evidence that sleep loss may have detrimental effects on brain health even in younger individuals. Larger cohorts are warranted to delineate sleep vs circadian mechanisms, implications for long-term recurrent conditions (e.g., in shift workers), as well as interactions with other lifestyle and genetic factors.",2020,"No changes between the sleep conditions were seen for levels of Aβ40, Aβ42, NfL, or GFAP (all  p  > 0.10).","['15 healthy young men participated in 2 standardized sedentary in-laboratory conditions in randomized order', 'young men']",['normal sleep vs overnight sleep loss'],"['levels of Aβ40, Aβ42, NfL, or GFAP', 'evening to morning ratio', 'blood levels', 'normal sleep', 'sleep loss', 'Plasma levels of Aβ42', 'CSF levels of tau and β-amyloid ', 'risk of Alzheimer disease (AD', 'diurnal plasma dynamics of CNS health biomarkers', 'Plasma levels of total tau (t-tau), Aβ40, Aβ42, neurofilament light chain (NfL), and glial fibrillary acidic protein (GFAP', 'GFAP']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}]","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0235161', 'cui_str': 'Sleep loss'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0017626', 'cui_str': 'Glial Intermediate Filament Protein'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0235161', 'cui_str': 'Sleep loss'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}]",15.0,0.110715,"No changes between the sleep conditions were seen for levels of Aβ40, Aβ42, NfL, or GFAP (all  p  > 0.10).","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Benedict', 'Affiliation': 'From the Departments of Neuroscience (C.B., J.C.) and Medical Sciences (J.C.), Uppsala University; Clinical Neurochemistry Laboratory (K.B., H.Z.), Sahlgrenska University Hospital; Department of Psychiatry and Neurochemistry (K.B., H.Z.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy at the University of Gothenburg, Mölndal, Sweden; Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology; and UK Dementia Research Institute at UCL (H.Z.), London, UK.'}, {'ForeName': 'Kaj', 'Initials': 'K', 'LastName': 'Blennow', 'Affiliation': 'From the Departments of Neuroscience (C.B., J.C.) and Medical Sciences (J.C.), Uppsala University; Clinical Neurochemistry Laboratory (K.B., H.Z.), Sahlgrenska University Hospital; Department of Psychiatry and Neurochemistry (K.B., H.Z.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy at the University of Gothenburg, Mölndal, Sweden; Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology; and UK Dementia Research Institute at UCL (H.Z.), London, UK.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Zetterberg', 'Affiliation': 'From the Departments of Neuroscience (C.B., J.C.) and Medical Sciences (J.C.), Uppsala University; Clinical Neurochemistry Laboratory (K.B., H.Z.), Sahlgrenska University Hospital; Department of Psychiatry and Neurochemistry (K.B., H.Z.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy at the University of Gothenburg, Mölndal, Sweden; Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology; and UK Dementia Research Institute at UCL (H.Z.), London, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Cedernaes', 'Affiliation': 'From the Departments of Neuroscience (C.B., J.C.) and Medical Sciences (J.C.), Uppsala University; Clinical Neurochemistry Laboratory (K.B., H.Z.), Sahlgrenska University Hospital; Department of Psychiatry and Neurochemistry (K.B., H.Z.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy at the University of Gothenburg, Mölndal, Sweden; Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology; and UK Dementia Research Institute at UCL (H.Z.), London, UK. jonathan.cedernaes@medsci.uu.se.'}]",Neurology,['10.1212/WNL.0000000000008866']
800,31932513,Interaction of serum vitamin B 12  and folate with  MTHFR  genotypes on risk of ischemic stroke.,"OBJECTIVE


We evaluated the interaction of serum folate and vitamin B 12  with methylenetetrahydrofolate reductase ( MTHFR ) C677T genotypes on the risk of first ischemic stroke and on the efficacy of folic acid treatment in prevention of first ischemic stroke.
METHODS


A total of 20,702 hypertensive adults were randomized to a double-blind treatment of daily enalapril 10 mg and folic acid 0.8 mg or enalapril 10 mg alone. Participants were followed up every 3 months.
RESULTS


Median values of folate and B 12  concentrations at baseline were 8.1 ng/mL and 280.2 pmol/L, respectively. Over a median of 4.5 years, among those not receiving folic acid, participants with baseline serum B 12  or serum folate above the median had a significantly lower risk of first ischemic stroke (hazard ratio [HR], 0.74; 95% confidence interval [CI], 0.57-0.96), especially in those with  MTHFR  677 CC genotype (wild-type) (HR, 0.49; 95% CI, 0.31-0.78). Folic acid treatment significantly reduced the risk of first ischemic stroke in participants with both folate and B 12  below the median (2.3% in enalapril-folic acid group vs 3.6% in enalapril-only group; HR, 0.62; 95% CI, 0.46-0.86), particularly in  MTHFR  677 CC carriers (1.6% vs 4.9%; HR, 0.24; 95% CI, 0.11-0.55). However, TT homozygotes responded better with both folate and B 12  levels above the median (HR, 0.28; 95% CI, 0.10-0.75).
CONCLUSIONS


The risk of first ischemic stroke was significantly higher in hypertensive patients with low levels of both folate and B 12 . Effect of folic acid treatment was greatest in patients with low folate and B 12  with the CC genotype, and with high folate and B 12  with the TT genotype.",2020,"Folic acid treatment significantly reduced the risk of first ischemic stroke in participants with both folate and B 12  below the median (2.3% in enalapril-folic acid group vs 3.6% in enalapril-only group; HR, 0.62; 95% CI, 0.46-0.86), particularly in  MTHFR  677 CC carriers (1.6% vs 4.9%; HR, 0.24; 95% CI, 0.11-0.55).","['20,702 hypertensive adults', 'hypertensive patients', 'patients with low folate and B 12  with the CC genotype, and with high folate and B 12  with the TT genotype']","['serum folate and vitamin B 12  with methylenetetrahydrofolate reductase ( MTHFR ) C677T genotypes', 'Folic acid', 'folic acid', 'daily enalapril 10 mg and folic acid 0.8 mg or enalapril 10 mg alone', 'enalapril', 'enalapril-folic acid', 'folic acid treatment', 'serum vitamin B 12  and folate with  MTHFR  genotypes']","['Median values of folate and B 12  concentrations', 'risk of first ischemic stroke']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0042845', 'cui_str': 'cyanocobalamin'}, {'cui': 'C0066357', 'cui_str': 'Methylenetetrahydrofolate Reductase (NADPH2)'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0986173', 'cui_str': 'Folic Acid 0.8 MG'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}]",677.0,0.0550573,"Folic acid treatment significantly reduced the risk of first ischemic stroke in participants with both folate and B 12  below the median (2.3% in enalapril-folic acid group vs 3.6% in enalapril-only group; HR, 0.62; 95% CI, 0.46-0.86), particularly in  MTHFR  677 CC carriers (1.6% vs 4.9%; HR, 0.24; 95% CI, 0.11-0.55).","[{'ForeName': 'Xianhui', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': ""From Renal Division (X.Q., Y.L., M.L., Y.Z., X.X.), Nanfang Hospital, Southern Medical University; National Clinical Research Center for Kidney Disease (X.Q., Y.L., M.L., Y.Z., X.X.); State Key Laboratory for Organ Failure Research (X.Q., Y.L., M.L., Y.Z., X.X.), Guangzhou, China; Stroke Prevention and Atherosclerosis Research Centre (J.D.S.), Robarts Research Institute, University of Western Ontario, London, Canada; Department of Cardiology (J.L., Y.Z., Y.H.), Peking University First Hospital; Department of Cardiology (N.S.), Peking University People's Hospital; Beijing Advanced Innovation Center for Food Nutrition and Human Health (Y.S.), Key Laboratory of Functional Dairy, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing; Institute for Biomedicine (B.W.), Anhui Medical University, Hefei; Department of Cardiology (X.C.), Second Affiliated Hospital, Nanchang University; Department of Cardiology (L.Z.), Tangdu Hospital, the Fourth Military Medical University, Xi'an, China; and Department of Population, Family and Reproductive Health (X.W.), Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.""}, {'ForeName': 'J David', 'Initials': 'JD', 'LastName': 'Spence', 'Affiliation': ""From Renal Division (X.Q., Y.L., M.L., Y.Z., X.X.), Nanfang Hospital, Southern Medical University; National Clinical Research Center for Kidney Disease (X.Q., Y.L., M.L., Y.Z., X.X.); State Key Laboratory for Organ Failure Research (X.Q., Y.L., M.L., Y.Z., X.X.), Guangzhou, China; Stroke Prevention and Atherosclerosis Research Centre (J.D.S.), Robarts Research Institute, University of Western Ontario, London, Canada; Department of Cardiology (J.L., Y.Z., Y.H.), Peking University First Hospital; Department of Cardiology (N.S.), Peking University People's Hospital; Beijing Advanced Innovation Center for Food Nutrition and Human Health (Y.S.), Key Laboratory of Functional Dairy, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing; Institute for Biomedicine (B.W.), Anhui Medical University, Hefei; Department of Cardiology (X.C.), Second Affiliated Hospital, Nanchang University; Department of Cardiology (L.Z.), Tangdu Hospital, the Fourth Military Medical University, Xi'an, China; and Department of Population, Family and Reproductive Health (X.W.), Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.""}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""From Renal Division (X.Q., Y.L., M.L., Y.Z., X.X.), Nanfang Hospital, Southern Medical University; National Clinical Research Center for Kidney Disease (X.Q., Y.L., M.L., Y.Z., X.X.); State Key Laboratory for Organ Failure Research (X.Q., Y.L., M.L., Y.Z., X.X.), Guangzhou, China; Stroke Prevention and Atherosclerosis Research Centre (J.D.S.), Robarts Research Institute, University of Western Ontario, London, Canada; Department of Cardiology (J.L., Y.Z., Y.H.), Peking University First Hospital; Department of Cardiology (N.S.), Peking University People's Hospital; Beijing Advanced Innovation Center for Food Nutrition and Human Health (Y.S.), Key Laboratory of Functional Dairy, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing; Institute for Biomedicine (B.W.), Anhui Medical University, Hefei; Department of Cardiology (X.C.), Second Affiliated Hospital, Nanchang University; Department of Cardiology (L.Z.), Tangdu Hospital, the Fourth Military Medical University, Xi'an, China; and Department of Population, Family and Reproductive Health (X.W.), Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""From Renal Division (X.Q., Y.L., M.L., Y.Z., X.X.), Nanfang Hospital, Southern Medical University; National Clinical Research Center for Kidney Disease (X.Q., Y.L., M.L., Y.Z., X.X.); State Key Laboratory for Organ Failure Research (X.Q., Y.L., M.L., Y.Z., X.X.), Guangzhou, China; Stroke Prevention and Atherosclerosis Research Centre (J.D.S.), Robarts Research Institute, University of Western Ontario, London, Canada; Department of Cardiology (J.L., Y.Z., Y.H.), Peking University First Hospital; Department of Cardiology (N.S.), Peking University People's Hospital; Beijing Advanced Innovation Center for Food Nutrition and Human Health (Y.S.), Key Laboratory of Functional Dairy, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing; Institute for Biomedicine (B.W.), Anhui Medical University, Hefei; Department of Cardiology (X.C.), Second Affiliated Hospital, Nanchang University; Department of Cardiology (L.Z.), Tangdu Hospital, the Fourth Military Medical University, Xi'an, China; and Department of Population, Family and Reproductive Health (X.W.), Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.""}, {'ForeName': 'Youbao', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""From Renal Division (X.Q., Y.L., M.L., Y.Z., X.X.), Nanfang Hospital, Southern Medical University; National Clinical Research Center for Kidney Disease (X.Q., Y.L., M.L., Y.Z., X.X.); State Key Laboratory for Organ Failure Research (X.Q., Y.L., M.L., Y.Z., X.X.), Guangzhou, China; Stroke Prevention and Atherosclerosis Research Centre (J.D.S.), Robarts Research Institute, University of Western Ontario, London, Canada; Department of Cardiology (J.L., Y.Z., Y.H.), Peking University First Hospital; Department of Cardiology (N.S.), Peking University People's Hospital; Beijing Advanced Innovation Center for Food Nutrition and Human Health (Y.S.), Key Laboratory of Functional Dairy, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing; Institute for Biomedicine (B.W.), Anhui Medical University, Hefei; Department of Cardiology (X.C.), Second Affiliated Hospital, Nanchang University; Department of Cardiology (L.Z.), Tangdu Hospital, the Fourth Military Medical University, Xi'an, China; and Department of Population, Family and Reproductive Health (X.W.), Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.""}, {'ForeName': 'Ningling', 'Initials': 'N', 'LastName': 'Sun', 'Affiliation': ""From Renal Division (X.Q., Y.L., M.L., Y.Z., X.X.), Nanfang Hospital, Southern Medical University; National Clinical Research Center for Kidney Disease (X.Q., Y.L., M.L., Y.Z., X.X.); State Key Laboratory for Organ Failure Research (X.Q., Y.L., M.L., Y.Z., X.X.), Guangzhou, China; Stroke Prevention and Atherosclerosis Research Centre (J.D.S.), Robarts Research Institute, University of Western Ontario, London, Canada; Department of Cardiology (J.L., Y.Z., Y.H.), Peking University First Hospital; Department of Cardiology (N.S.), Peking University People's Hospital; Beijing Advanced Innovation Center for Food Nutrition and Human Health (Y.S.), Key Laboratory of Functional Dairy, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing; Institute for Biomedicine (B.W.), Anhui Medical University, Hefei; Department of Cardiology (X.C.), Second Affiliated Hospital, Nanchang University; Department of Cardiology (L.Z.), Tangdu Hospital, the Fourth Military Medical University, Xi'an, China; and Department of Population, Family and Reproductive Health (X.W.), Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Liang', 'Affiliation': ""From Renal Division (X.Q., Y.L., M.L., Y.Z., X.X.), Nanfang Hospital, Southern Medical University; National Clinical Research Center for Kidney Disease (X.Q., Y.L., M.L., Y.Z., X.X.); State Key Laboratory for Organ Failure Research (X.Q., Y.L., M.L., Y.Z., X.X.), Guangzhou, China; Stroke Prevention and Atherosclerosis Research Centre (J.D.S.), Robarts Research Institute, University of Western Ontario, London, Canada; Department of Cardiology (J.L., Y.Z., Y.H.), Peking University First Hospital; Department of Cardiology (N.S.), Peking University People's Hospital; Beijing Advanced Innovation Center for Food Nutrition and Human Health (Y.S.), Key Laboratory of Functional Dairy, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing; Institute for Biomedicine (B.W.), Anhui Medical University, Hefei; Department of Cardiology (X.C.), Second Affiliated Hospital, Nanchang University; Department of Cardiology (L.Z.), Tangdu Hospital, the Fourth Military Medical University, Xi'an, China; and Department of Population, Family and Reproductive Health (X.W.), Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': ""From Renal Division (X.Q., Y.L., M.L., Y.Z., X.X.), Nanfang Hospital, Southern Medical University; National Clinical Research Center for Kidney Disease (X.Q., Y.L., M.L., Y.Z., X.X.); State Key Laboratory for Organ Failure Research (X.Q., Y.L., M.L., Y.Z., X.X.), Guangzhou, China; Stroke Prevention and Atherosclerosis Research Centre (J.D.S.), Robarts Research Institute, University of Western Ontario, London, Canada; Department of Cardiology (J.L., Y.Z., Y.H.), Peking University First Hospital; Department of Cardiology (N.S.), Peking University People's Hospital; Beijing Advanced Innovation Center for Food Nutrition and Human Health (Y.S.), Key Laboratory of Functional Dairy, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing; Institute for Biomedicine (B.W.), Anhui Medical University, Hefei; Department of Cardiology (X.C.), Second Affiliated Hospital, Nanchang University; Department of Cardiology (L.Z.), Tangdu Hospital, the Fourth Military Medical University, Xi'an, China; and Department of Population, Family and Reproductive Health (X.W.), Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.""}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""From Renal Division (X.Q., Y.L., M.L., Y.Z., X.X.), Nanfang Hospital, Southern Medical University; National Clinical Research Center for Kidney Disease (X.Q., Y.L., M.L., Y.Z., X.X.); State Key Laboratory for Organ Failure Research (X.Q., Y.L., M.L., Y.Z., X.X.), Guangzhou, China; Stroke Prevention and Atherosclerosis Research Centre (J.D.S.), Robarts Research Institute, University of Western Ontario, London, Canada; Department of Cardiology (J.L., Y.Z., Y.H.), Peking University First Hospital; Department of Cardiology (N.S.), Peking University People's Hospital; Beijing Advanced Innovation Center for Food Nutrition and Human Health (Y.S.), Key Laboratory of Functional Dairy, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing; Institute for Biomedicine (B.W.), Anhui Medical University, Hefei; Department of Cardiology (X.C.), Second Affiliated Hospital, Nanchang University; Department of Cardiology (L.Z.), Tangdu Hospital, the Fourth Military Medical University, Xi'an, China; and Department of Population, Family and Reproductive Health (X.W.), Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.""}, {'ForeName': 'Binyan', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': ""From Renal Division (X.Q., Y.L., M.L., Y.Z., X.X.), Nanfang Hospital, Southern Medical University; National Clinical Research Center for Kidney Disease (X.Q., Y.L., M.L., Y.Z., X.X.); State Key Laboratory for Organ Failure Research (X.Q., Y.L., M.L., Y.Z., X.X.), Guangzhou, China; Stroke Prevention and Atherosclerosis Research Centre (J.D.S.), Robarts Research Institute, University of Western Ontario, London, Canada; Department of Cardiology (J.L., Y.Z., Y.H.), Peking University First Hospital; Department of Cardiology (N.S.), Peking University People's Hospital; Beijing Advanced Innovation Center for Food Nutrition and Human Health (Y.S.), Key Laboratory of Functional Dairy, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing; Institute for Biomedicine (B.W.), Anhui Medical University, Hefei; Department of Cardiology (X.C.), Second Affiliated Hospital, Nanchang University; Department of Cardiology (L.Z.), Tangdu Hospital, the Fourth Military Medical University, Xi'an, China; and Department of Population, Family and Reproductive Health (X.W.), Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.""}, {'ForeName': 'Xiaoshu', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': ""From Renal Division (X.Q., Y.L., M.L., Y.Z., X.X.), Nanfang Hospital, Southern Medical University; National Clinical Research Center for Kidney Disease (X.Q., Y.L., M.L., Y.Z., X.X.); State Key Laboratory for Organ Failure Research (X.Q., Y.L., M.L., Y.Z., X.X.), Guangzhou, China; Stroke Prevention and Atherosclerosis Research Centre (J.D.S.), Robarts Research Institute, University of Western Ontario, London, Canada; Department of Cardiology (J.L., Y.Z., Y.H.), Peking University First Hospital; Department of Cardiology (N.S.), Peking University People's Hospital; Beijing Advanced Innovation Center for Food Nutrition and Human Health (Y.S.), Key Laboratory of Functional Dairy, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing; Institute for Biomedicine (B.W.), Anhui Medical University, Hefei; Department of Cardiology (X.C.), Second Affiliated Hospital, Nanchang University; Department of Cardiology (L.Z.), Tangdu Hospital, the Fourth Military Medical University, Xi'an, China; and Department of Population, Family and Reproductive Health (X.W.), Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.""}, {'ForeName': 'Lianyou', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': ""From Renal Division (X.Q., Y.L., M.L., Y.Z., X.X.), Nanfang Hospital, Southern Medical University; National Clinical Research Center for Kidney Disease (X.Q., Y.L., M.L., Y.Z., X.X.); State Key Laboratory for Organ Failure Research (X.Q., Y.L., M.L., Y.Z., X.X.), Guangzhou, China; Stroke Prevention and Atherosclerosis Research Centre (J.D.S.), Robarts Research Institute, University of Western Ontario, London, Canada; Department of Cardiology (J.L., Y.Z., Y.H.), Peking University First Hospital; Department of Cardiology (N.S.), Peking University People's Hospital; Beijing Advanced Innovation Center for Food Nutrition and Human Health (Y.S.), Key Laboratory of Functional Dairy, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing; Institute for Biomedicine (B.W.), Anhui Medical University, Hefei; Department of Cardiology (X.C.), Second Affiliated Hospital, Nanchang University; Department of Cardiology (L.Z.), Tangdu Hospital, the Fourth Military Medical University, Xi'an, China; and Department of Population, Family and Reproductive Health (X.W.), Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.""}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""From Renal Division (X.Q., Y.L., M.L., Y.Z., X.X.), Nanfang Hospital, Southern Medical University; National Clinical Research Center for Kidney Disease (X.Q., Y.L., M.L., Y.Z., X.X.); State Key Laboratory for Organ Failure Research (X.Q., Y.L., M.L., Y.Z., X.X.), Guangzhou, China; Stroke Prevention and Atherosclerosis Research Centre (J.D.S.), Robarts Research Institute, University of Western Ontario, London, Canada; Department of Cardiology (J.L., Y.Z., Y.H.), Peking University First Hospital; Department of Cardiology (N.S.), Peking University People's Hospital; Beijing Advanced Innovation Center for Food Nutrition and Human Health (Y.S.), Key Laboratory of Functional Dairy, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing; Institute for Biomedicine (B.W.), Anhui Medical University, Hefei; Department of Cardiology (X.C.), Second Affiliated Hospital, Nanchang University; Department of Cardiology (L.Z.), Tangdu Hospital, the Fourth Military Medical University, Xi'an, China; and Department of Population, Family and Reproductive Health (X.W.), Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.""}, {'ForeName': 'Xiping', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""From Renal Division (X.Q., Y.L., M.L., Y.Z., X.X.), Nanfang Hospital, Southern Medical University; National Clinical Research Center for Kidney Disease (X.Q., Y.L., M.L., Y.Z., X.X.); State Key Laboratory for Organ Failure Research (X.Q., Y.L., M.L., Y.Z., X.X.), Guangzhou, China; Stroke Prevention and Atherosclerosis Research Centre (J.D.S.), Robarts Research Institute, University of Western Ontario, London, Canada; Department of Cardiology (J.L., Y.Z., Y.H.), Peking University First Hospital; Department of Cardiology (N.S.), Peking University People's Hospital; Beijing Advanced Innovation Center for Food Nutrition and Human Health (Y.S.), Key Laboratory of Functional Dairy, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing; Institute for Biomedicine (B.W.), Anhui Medical University, Hefei; Department of Cardiology (X.C.), Second Affiliated Hospital, Nanchang University; Department of Cardiology (L.Z.), Tangdu Hospital, the Fourth Military Medical University, Xi'an, China; and Department of Population, Family and Reproductive Health (X.W.), Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD. huoyong@263.net.cn xipingxu126@126.com.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huo', 'Affiliation': ""From Renal Division (X.Q., Y.L., M.L., Y.Z., X.X.), Nanfang Hospital, Southern Medical University; National Clinical Research Center for Kidney Disease (X.Q., Y.L., M.L., Y.Z., X.X.); State Key Laboratory for Organ Failure Research (X.Q., Y.L., M.L., Y.Z., X.X.), Guangzhou, China; Stroke Prevention and Atherosclerosis Research Centre (J.D.S.), Robarts Research Institute, University of Western Ontario, London, Canada; Department of Cardiology (J.L., Y.Z., Y.H.), Peking University First Hospital; Department of Cardiology (N.S.), Peking University People's Hospital; Beijing Advanced Innovation Center for Food Nutrition and Human Health (Y.S.), Key Laboratory of Functional Dairy, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing; Institute for Biomedicine (B.W.), Anhui Medical University, Hefei; Department of Cardiology (X.C.), Second Affiliated Hospital, Nanchang University; Department of Cardiology (L.Z.), Tangdu Hospital, the Fourth Military Medical University, Xi'an, China; and Department of Population, Family and Reproductive Health (X.W.), Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD. huoyong@263.net.cn xipingxu126@126.com.""}]",Neurology,['10.1212/WNL.0000000000008932']
801,32401625,The Effect of Home Base Physical Activity Program based on the BASNEF Model on Motor Recovery in Patients with Stroke.,"The present study aimed to determine the effect of education based on the BASNEF model on the physical activity and improvement of motor activity in patients with stroke. This randomized control trial study was conducted on 40 patients with acute ischemic stroke admitted to a teaching hospital in Isfahan, Iran from August 2017 to September 2018. The patients were randomly divided into intervention and control groups. The intervention included personal education and a manual CD of physical activity for the intervention group. After education, the mean scores of the BASNEF model's constructs in the intervention group were significantly higher than those of the control group ( P  < .001). Furthermore, the motor ability of the intervention group in upper and lower extremities was significantly higher than that of the control group ( p  < .001). Interventions based on educational models can increase the motivation of patients with stroke in performing recommended physical activity.",2020,"Furthermore, the motor ability of the intervention group in upper and lower extremities was significantly higher than that of the control group ( p  < .001).","['Patients with Stroke', '40 patients with acute ischemic stroke admitted to a teaching hospital in Isfahan, Iran from August 2017 to September 2018', 'patients with stroke']",['Home Base Physical Activity Program'],"['motor ability', ""mean scores of the BASNEF model's constructs"", 'upper and lower extremities', 'motor activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",40.0,0.0142828,"Furthermore, the motor ability of the intervention group in upper and lower extremities was significantly higher than that of the control group ( p  < .001).","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Esteki-Ghashghaei', 'Affiliation': 'Isfahan Neurosciences Research Center, Alzahra Hospital, Isfahan University of Medical Sciences , Isfahan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Saadatnia', 'Affiliation': 'Isfahan Neurosciences Research Center, Alzahra Hospital, Isfahan University of Medical Sciences , Isfahan, Iran.'}, {'ForeName': 'Fariborz', 'Initials': 'F', 'LastName': 'Khorvash', 'Affiliation': 'Isfahan Neurosciences Research Center, Alzahra Hospital, Isfahan University of Medical Sciences , Isfahan, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Shahnazi', 'Affiliation': 'Department of Health Education and Promotion, School of Health, Isfahan University of Medical Sciences , Isfahan, Iran.'}]",Home health care services quarterly,['10.1080/01621424.2020.1765938']
802,32176711,Representation of patients with a migration background in studies on antithrombotic treatment. An analysis of recruitment data from a cluster randomized controlled trial.,"BACKGROUND


The health status, health awareness and health behavior of persons with a migration background often differ from the autochthonous population. Little is known about the proportion of patients with a migration background (PMB) that participate in primary care studies on oral antithrombotic treatment (OAT) in Germany, and whether the quality of their antithrombotic care differs from patients without a migration background. The aim of this paper was to use the results of a cluster-randomized controlled trial (PICANT) to determine the proportion of PMB at different stages of recruitment, and to compare the results in terms of sociodemographic characteristics and antithrombotic treatment.
METHODS


This study used screening and baseline data from the PICANT trial on oral anticoagulation management in GP practices. For this analysis, we determined the proportion of PMB during the recruitment period at stage 1 (screening of potentially eligible patients), stage 2 (eligible patients invited to participate in the trial), and stage 3 (assessment of baseline characteristics of patients participating in the PICANT trial). In addition, we compared patients in terms of sociodemographic characteristics and quality of anticoagulant treatment. Statistical analysis comprised descriptive and bivariate analyses.
RESULTS


The proportion of PMB at each recruitment stage declined from 9.1% at stage 1 to 7.9% at stage 2 and 7.3% at stage 3). A lack of German language skills led to the exclusion of half the otherwise eligible PMB. At stages 1 and 3, PMB were younger (stage 1: 70.7 vs. 75.0 years, p<0.001; stage 3: 70.2 vs. 73.5 years, p = 0.013), but did not differ in terms of gender. The quality of their anticoagulant care was comparable (100.0% vs. 99.1% were receiving appropriate OAT, 94.4% vs. 95.7% took phenprocoumon, or warfarin, and the most recent INR measurement of 60.8% vs. 69.3% was within their individual INR range).
CONCLUSIONS


In the potentially eligible population and among participants at baseline, the quality of anticoagulant care was high in all groups of patients, which is reassuring. To enable the inclusion of more PMB, future primary care research on OAT in Germany should address how best to overcome language barriers. This will be challenging, particularly because the heterogeneity of PMB means the resulting sample sizes for each specific language group are small.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN41847489.",2020,"In the potentially eligible population and among participants at baseline, the quality of anticoagulant care was high in all groups of patients, which is reassuring.","['GP practices', 'potentially eligible patients), stage 2 (eligible patients invited to participate in the trial), and stage 3 (assessment of baseline characteristics of patients participating in the PICANT trial', 'patients with a migration background in studies on antithrombotic treatment']",[],"['quality of their anticoagulant care', 'quality of anticoagulant care', 'proportion of PMB']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1533574', 'cui_str': 'Migration, function (observable entity)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],"[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}]",,0.201566,"In the potentially eligible population and among participants at baseline, the quality of anticoagulant care was high in all groups of patients, which is reassuring.","[{'ForeName': 'Karola', 'Initials': 'K', 'LastName': 'Mergenthal', 'Affiliation': 'Institute of General Practice, Goethe University Frankfurt am Main, Frankfurt am Main, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Siebenhofer', 'Affiliation': 'Institute of General Practice, Goethe University Frankfurt am Main, Frankfurt am Main, Germany.'}, {'ForeName': 'Lisa-R', 'Initials': 'LR', 'LastName': 'Ulrich', 'Affiliation': 'Institute of General Practice, Goethe University Frankfurt am Main, Frankfurt am Main, Germany.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Guethlin', 'Affiliation': 'Institute of General Practice, Goethe University Frankfurt am Main, Frankfurt am Main, Germany.'}, {'ForeName': 'Ferdinand M', 'Initials': 'FM', 'LastName': 'Gerlach', 'Affiliation': 'Institute of General Practice, Goethe University Frankfurt am Main, Frankfurt am Main, Germany.'}, {'ForeName': 'Juliana J', 'Initials': 'JJ', 'LastName': 'Petersen', 'Affiliation': 'Institute of General Practice, Goethe University Frankfurt am Main, Frankfurt am Main, Germany.'}]",PloS one,['10.1371/journal.pone.0230297']
803,32182241,"Effectiveness of a culturally appropriate nutrition educational intervention delivered through health services to improve growth and complementary feeding of infants: A quasi-experimental study from Chandigarh, India.","BACKGROUND


Malnutrition is a major public health problem in India, especially among urban poor children. The objective of the study was to determine the effectiveness of a culturally appropriate nutrition educational intervention that can be delivered through health services and digitized child undernutrition tracking module for health workers to improve complementary feeding of infants of age six months to 12 months in Chandigarh, North India, to prevent malnutrition in infants.
METHODS


A quasi-experimental study was conducted in a non-randomized intervention (Burail) and control area (Maloya) among a vulnerable population in Chandigarh, North India. The mother-infant dyads (MIDs) in the intervention group(n = 202) received culturally appropriate nutrition educational intervention, were supported individually by trained health workers in infant feeding and followed up for six months. Health workers were monitored through a digitized tracking module. The MIDs in the control group (n = 202) received routine care under the national health program. The mean (±S.D.) age of infants in the intervention and control group was 5.4 (±0.8) months and 5.5 (±0.7) months, respectively. The data was collected using a pre-tested semi-structured questionnaire and anthropometry of infants at baseline and end line. The primary outcome was a mean change in weight. The effectiveness of the intervention was measured by conducting the difference in difference (DID) analysis in mean change in weight between intervention and control group.
RESULT


At baseline, the mean (±S.D.) weight of infants was 6.6(±0.64) kg and 6.6 (±0.52) kg in the intervention and control group. The mean (±S.D.) length of infants was 64.3 (±2.0) cm in the intervention group and 65.1 (±1.7) cm in the control group. Out of 404, 190 and 191 MIDs in the intervention and control group completed the study, respectively. A significantly higher number of infants in the intervention group were started on complementary feeding at six months of age (72.6% versus45.5%, p<0.01) and received foods having thick consistency (82.1% versus 41.9%, p<-0.01). There was significant weight gain in intervention group infants (DID means = 0.27 kg, p<0.01) and length gain (DID means = 0.9 cm, p<0.01) from the baseline. Also, there was significant decline in the proportion of undernourished (10% versus18.8%, OR = 0.47, p = 0.01) and wasted infants (7.3% versus15.7%, OR = 0.42, p = 0.01) in the intervention group.
CONCLUSION


Community-based nutrition educational intervention delivered through the routine health services and digitized tracking of malnourished children can effectively improve the complementary feeding and growth of children six months to one year among vulnerable populations.",2020,"There was significant weight gain in intervention group infants (DID means = 0.27 kg, p<0.01) and length gain (DID means = 0.9 cm, p<0.01) from the baseline.","['A quasi-experimental study was conducted in a non-randomized intervention (Burail) and control area (Maloya) among a vulnerable population in Chandigarh, North India', 'urban poor children', 'malnourished children', 'infants of age six months to 12 months in Chandigarh, North India, to prevent malnutrition in infants', 'infants']","['culturally appropriate nutrition educational intervention', 'Community-based nutrition educational intervention', 'routine care under the national health program']","['mean (±S.D.) length of infants', 'proportion of undernourished', 'length gain', 'weight gain', 'mean change in weight']","[{'cui': 'C2985410', 'cui_str': 'Clinical Trials, Nonrandomized'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0949366', 'cui_str': 'Vulnerable Populations'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C1257752', 'cui_str': 'Infant Malnutrition'}]","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0027459', 'cui_str': 'National Health Programs'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",,0.0381763,"There was significant weight gain in intervention group infants (DID means = 0.27 kg, p<0.01) and length gain (DID means = 0.9 cm, p<0.01) from the baseline.","[{'ForeName': 'Nikita', 'Initials': 'N', 'LastName': 'Sharma', 'Affiliation': 'Department of Community Medicine and School of Public Health, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Madhu', 'Initials': 'M', 'LastName': 'Gupta', 'Affiliation': 'Department of Community Medicine and School of Public Health, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Arun Kumar', 'Initials': 'AK', 'LastName': 'Aggarwal', 'Affiliation': 'Department of Community Medicine and School of Public Health, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Mutyalamma', 'Initials': 'M', 'LastName': 'Gorle', 'Affiliation': 'Dietetics Department, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}]",PloS one,['10.1371/journal.pone.0229755']
804,31399883,Pharmacokinetics and Bioequivalence of Memantine Tablet and a New Dry Syrup Formulation in Healthy Japanese Males: Two Single-Dose Crossover Studies.,"INTRODUCTION


Memantine hydrochloride, an N-methyl-D-aspartate receptor antagonist, is used to treat Alzheimer's disease (AD). A new dry syrup formulation containing memantine hydrochloride has been developed to improve medication adherence in AD patients and to reduce family and caregiver burden. This study was conducted to assess the bioequivalence of this new formulation to the tablet.
METHODS


Two single-dose, randomized, open-label, two-period, two-group, crossover studies were conducted to assess the bioequivalence of a test product [dry syrup, 2%, 1 g (containing 20 mg of memantine hydrochloride)] to a reference product (film-coated tablet) under two dosing conditions: administration of the test product as a suspension in water (Study I) and as granules taken with water (Study II). Blood samples were collected at specified time intervals, and memantine plasma concentrations were determined using a validated liquid chromatography tandem mass spectrometry method. The pharmacokinetic parameters of memantine were calculated using non-compartmental analysis. The maximum concentration (C max ) and area under the concentration-time curve up to the last sampling time (AUC all ) were used to assess the bioequivalence of the two formulations.
RESULTS


The geometric least square mean (GLSM) ratios [90% confidence interval (CI)] of the C max  and AUC all  of memantine for the test product to the reference product were 0.981 (0.943-1.020) and 0.978 (0.955-1.001) in Study I, and 0.973 (0.944-1.003) and 1.004 (0.983-1.025) in Study II, respectively. In both studies, the 90% CI values of the GLSM ratios of C max  and AUC all  were within the prespecified bioequivalence range (0.80-1.25). The safety of the test product under both dosing conditions and that of the reference product were not different.
CONCLUSIONS


The new dry syrup formulation containing memantine hydrochloride showed bioequivalence to the film-coated tablet under the two dosing conditions. Thus, the new dry syrup is suitable under either dosing condition for patients with AD.
FUNDING


Daiichi Sankyo Co., Ltd.",2019,The new dry syrup formulation containing memantine hydrochloride showed bioequivalence to the film-coated tablet under the two dosing conditions.,"['patients with AD', 'Healthy Japanese Males']","['memantine', 'Memantine hydrochloride', 'memantine hydrochloride', 'Memantine Tablet and a New Dry Syrup Formulation']","['maximum concentration (C max ) and area under the concentration-time curve', 'GLSM ratios of C max  and AUC', 'medication adherence', 'geometric least square mean (GLSM) ratios']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0771988', 'cui_str': 'Memantine hydrochloride'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0458173', 'cui_str': 'Syrup (substance)'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0287741,The new dry syrup formulation containing memantine hydrochloride showed bioequivalence to the film-coated tablet under the two dosing conditions.,"[{'ForeName': 'Yutaro', 'Initials': 'Y', 'LastName': 'Maekawa', 'Affiliation': 'Daiichi Sankyo Co., Ltd., Tokyo, Japan. maekawa.yutaro.jb@daiichisankyo.co.jp.'}, {'ForeName': 'Setsuo', 'Initials': 'S', 'LastName': 'Hasegawa', 'Affiliation': 'Pharmaspur Inc., Tokyo, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Ishizuka', 'Affiliation': 'Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Kazuhito', 'Initials': 'K', 'LastName': 'Shiosakai', 'Affiliation': 'Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Ishizuka', 'Affiliation': 'Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}]",Advances in therapy,['10.1007/s12325-019-01044-y']
805,32200381,The Effect of Moderate Weight Loss on a Non-Invasive Biomarker of Liver Fibrosis: A Randomised Controlled Trial.,"BACKGROUND


Referral to weight loss programmes is the only effective treatment for non-alcoholic fatty liver disease (NAFLD). Clinicians should advise weight loss and screen for liver fibrosis using the Enhanced Liver Fibrosis (ELF) score.
AIM


To examine if the ELF score changes with weight loss.
DESIGN AND SETTING


Randomised controlled trial (ISRCTN85485463) in UK primary care during 2007-2008.
METHOD


Adults with a BMI of 27-35 kg/m2 and ≥1 risk factor for obesity-related disease were randomised to attend a community weight loss programme (n = 45) or receive usual weight loss advice from a practice nurse (n = 28). Weight and the ELF score were measured at baseline and 1 year. Analysis of covariance examined mean changes in the ELF score between groups and its relationship with weight loss.
RESULTS


Mean (SD) BMI was 31.10 kg/m2 (2.55) with evidence of moderate levels of liver fibrosis at baseline (mean ELF score: 8.93 [0.99]). There was no evidence that the community weight loss programme reduced the ELF score compared with usual care (difference +0.13 points, 95% CI: -0.25 to 0.52) despite greater weight loss (difference: -2.66 kg, 95% CI: -5.02 to -0.30). Mean weight loss in the whole cohort was 7.8% (5.9). There was no evidence of an association between weight change and change in ELF; the coefficient for a 5% weight loss was -0.15 (95% CI: -0.30 to 0.0002).
CONCLUSION


We found no evidence that the ELF score changed meaningfully following moderate weight loss. Clinicians should not use the ELF score to measure improvements in NAFLD fibrosis following weight loss programmes.",2020,"There was no evidence that the community weight loss programme reduced the ELF score compared with usual care (difference +0.13 points, 95% CI: -0.25 to 0.52) despite greater weight loss (difference: -2.66 kg, 95% CI: -5.02 to -0.30).","['Liver Fibrosis', 'Adults with a BMI of 27-35 kg/m2 and ≥1 risk factor for obesity-related disease']",['community weight loss programme (n = 45) or receive usual weight loss advice from a practice nurse'],"['Mean (SD) BMI', 'weight loss', 'ELF score', 'liver fibrosis', 'Weight and the ELF score', 'weight change and change in ELF', 'Mean weight loss']","[{'cui': 'C0239946', 'cui_str': 'Fibrosis, Liver'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0401999', 'cui_str': 'Practice nurse (occupation)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0239946', 'cui_str': 'Fibrosis, Liver'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.0843843,"There was no evidence that the community weight loss programme reduced the ELF score compared with usual care (difference +0.13 points, 95% CI: -0.25 to 0.52) despite greater weight loss (difference: -2.66 kg, 95% CI: -5.02 to -0.30).","[{'ForeName': 'Dimitrios A', 'Initials': 'DA', 'LastName': 'Koutoukidis', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom, dimitrios.koutoukidis@phc.ox.ac.uk.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Nerys M', 'Initials': 'NM', 'LastName': 'Astbury', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}]",Obesity facts,['10.1159/000505667']
806,31562608,A Randomized Pilot Study of the Effect of Trelagliptin and Alogliptin on Glycemic Variability in Patients with Type 2 Diabetes.,"INTRODUCTION


This open-label, parallel-group, exploratory study examined the effects of two dipeptidyl peptidase 4 (DPP4) inhibitors on glycemic variability (GV) in patients with type 2 diabetes.
METHODS


Randomized patients with glycated hemoglobin A1c of at least 6.5% to less than 8.5% received trelagliptin 100 mg (n = 13) once weekly or alogliptin 25 mg (n = 14) once daily for 29 days. Continuous glucose monitoring was performed before the start of the treatment period (baseline) and from day 21 to 29, inclusive. The primary endpoint was change from baseline in the standard deviation (SD) of 24-h blood glucose values, measured daily for 7 days (day 22-28) of the treatment period. Secondary and additional efficacy endpoints included changes in glycemic parameters and the rate of DPP4 inhibition, respectively. Adverse events (AEs) were monitored to assess safety.
RESULTS


Mean change from baseline in the SD of 24-h blood glucose (95% confidence interval) at day 28 was - 7.35 (- 15.13, 0.44) for trelagliptin and - 11.63 (- 18.67, - 4.59) for alogliptin. In both treatment groups, glycemic parameters improved and the rate of DPP4 inhibition was maintained. Three patients reported AEs; no severe treatment-emergent AEs were reported in either group.
CONCLUSION


Once-weekly trelagliptin and once-daily alogliptin improved glycemic control and reduced GV without inducing hypoglycemia.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT02771093) and JAPIC (JapicCTI-163250).
FUNDING


Takeda Pharmaceutical Company, Ltd.",2019,"CONCLUSION


Once-weekly trelagliptin and once-daily alogliptin improved glycemic control and reduced GV without inducing hypoglycemia.
","['patients with type 2 diabetes', 'Randomized patients with glycated hemoglobin A1c of at least 6.5% to less than 8.5% received', 'Patients with Type 2 Diabetes']","['Trelagliptin and Alogliptin', 'trelagliptin 100\xa0mg (n\u2009=\u200913) once weekly or alogliptin 25\xa0mg', 'dipeptidyl peptidase\xa04 (DPP4) inhibitors']","['24-h blood glucose', 'Glycemic Variability', 'standard deviation (SD) of 24-h blood glucose values', 'changes in glycemic parameters and the rate of DPP4 inhibition', 'rate of DPP4 inhibition', 'severe treatment-emergent AEs', 'glycemic variability (GV', 'glycemic parameters']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C4517877', 'cui_str': '8.5'}]","[{'cui': 'C4045234', 'cui_str': 'trelagliptin'}, {'cui': 'C1958126', 'cui_str': 'alogliptin'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0558293', 'cui_str': 'Once a week (qualifier value)'}, {'cui': 'C3536459', 'cui_str': 'alogliptin 25 MG'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl-Peptidase 4 Inhibitors'}]","[{'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.215281,"CONCLUSION


Once-weekly trelagliptin and once-daily alogliptin improved glycemic control and reduced GV without inducing hypoglycemia.
","[{'ForeName': 'Rimei', 'Initials': 'R', 'LastName': 'Nishimura', 'Affiliation': 'Department of Diabetes, Metabolism and Endocrinology, Jikei University School of Medicine, Minato-ku, Tokyo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Osonoi', 'Affiliation': 'Department of Internal Medicine, Nakakinen Clinic, Naka-city, Ibaraki, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Koike', 'Affiliation': 'Japan Medical Affairs, Japan Pharma Business Unit, Takeda Pharmaceutical Company Limited, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Kouji', 'Initials': 'K', 'LastName': 'Miyata', 'Affiliation': 'Japan Medical Affairs, Japan Pharma Business Unit, Takeda Pharmaceutical Company Limited, Chuo-ku, Tokyo, Japan. kouji.miyata@takeda.com.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Shimasaki', 'Affiliation': 'Japan Medical Affairs, Japan Pharma Business Unit, Takeda Pharmaceutical Company Limited, Chuo-ku, Tokyo, Japan.'}]",Advances in therapy,['10.1007/s12325-019-01097-z']
807,31916303,Nicotine replacement therapy sampling for smoking cessation within primary care: results from a pragmatic cluster randomized clinical trial.,"BACKGROUND AND AIMS


Within the context of busy clinical settings, health-care providers need practical, evidence-based options to engage smokers in quitting. Sampling of nicotine replacement therapy [i.e. provision of nicotine replacement therapy (NRT starter kits)] is a brief, pragmatic strategy to address this need. We aimed to compare the effects of NRT sampling plus standard care (SC), relative to SC alone, provided by primary care providers during routine clinic visits.
DESIGN


Cluster-randomized clinical trial.
SETTING


Twenty-two primary care clinics in South Carolina, USA.
PARTICIPANTS


Adult smokers [n = 1245; 61% female, mean age = 50.7, standard deviation (SD) = 13.5] both motivated and unmotivated to quit, seen during routine clinical visit. Interventions were provider-delivered SC (n = 652, 12 clinics) cessation advice or SC + a 2-week supply of both nicotine patch and lozenge, with minimal instructions on use (n = 593; 10 clinics).
MEASUREMENTS


The primary outcome was 7-day point prevalence smoking abstinence at 6-month follow-up, using intent-to-treat. Additional outcomes included NRT use and quit attempts, assessed at 1, 3 and 6 months following baseline.
FINDINGS


Seven-day point prevalence abstinence rates were significantly higher in the NRT sampling group throughout follow-up, including at 6 months [12 versus 8%, odds ratio (OR) = 1.5, 95% confidence interval (CI) = 1.0-2.4]. NRT sampling increased prevalence of any use of NRT (65 versus 25%, OR = 5.8, 95% CI = 4.3-7.7), with higher prevalence of use at 6 months (25 versus 14%, OR = 2.0, 95% CI = 1.5-2.7). NRT sampling increased the rate of quit attempts in the initial month (24 versus 18%, OR = 1.5, 95% CI = 1.0-2.3) but had no significant effect on overall rate of quit attempts (48 versus 45%, OR = 1.2, 95% CI = 0.8-1.7).
CONCLUSION


Providing smokers with a free 2-week starter kit of nicotine replacement therapy increased quit attempts, use of stop smoking medications and smoking abstinence compared with standard care in a primary care setting.",2020,"FINDINGS


Seven-day point prevalence abstinence rates were significantly higher in the NRT sampling group throughout follow-up, including at 6 months (12% vs. 8%; Odds Ratio [OR] = 1.5; 95% Confidence Interval [CI]: 1.0 - 2.4).","['smoking cessation within primary care', '22 primary care clinics in South Carolina, USA', 'Adult smokers (N=1245; 61% female, mean age 50.7, (SD=13.5) both motivated and unmotivated to quit, seen during routine clinical visit']","['nicotine replacement therapy (i.e., provision of NRT starter kits', 'NRT sampling plus standard care (SC', 'nicotine replacement therapy', 'NRT', 'Provider-delivered SC (n=652, 12 clinics) cessation advice, or SC + a two-week supply of both nicotine patch and lozenge, with minimal instructions', 'Nicotine replacement therapy sampling']","['7-day point prevalence smoking abstinence', 'quit attempts, use of stop smoking medications, and smoking abstinence', 'overall rate of quit attempts', 'NRT use and quit attempts', 'rate of quit attempts', 'prevalence abstinence rates']","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0037716', 'cui_str': 'South Carolina'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C4319836', 'cui_str': 'Lozenge'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0425310', 'cui_str': 'Stopped smoking (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",22.0,0.138011,"FINDINGS


Seven-day point prevalence abstinence rates were significantly higher in the NRT sampling group throughout follow-up, including at 6 months (12% vs. 8%; Odds Ratio [OR] = 1.5; 95% Confidence Interval [CI]: 1.0 - 2.4).","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Carpenter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Wahlquist', 'Affiliation': 'Department of Public Health Sciences,, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Dahne', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Gray', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Garrett-Mayer', 'Affiliation': 'Department of Public Health Sciences,, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'K Michael', 'Initials': 'KM', 'LastName': 'Cummings', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Davis', 'Affiliation': 'Greenville Health System and Care Coordination Institute, Greenville, SC, USA.'}, {'ForeName': 'Brent M', 'Initials': 'BM', 'LastName': 'Egan', 'Affiliation': 'Greenville Health System and Care Coordination Institute, Greenville, SC, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.14953']
808,32157765,New local treatments for different types of melasma: Vascular type vs nonvascular type. A randomized polycentric study.,"Melasma is an acquired circumscribed hyperpigmented disorder seen mainly on the malar area of face and other parts of body. We evaluated the safety and efficacy of two different creams for melasma. Sixty volunteers with melasma were evaluated in this study, divided in three groups: A, B, and C. Patients in groups A and B were treated with same creams with the exception of addition of Tranexamic acid in cream B. Patients in group C were treated with placebo cream containing petrolatum only, respectively, twice daily for 10 weeks. Melasma Areas and Severity Index (MASI) score, melanin index (MI) and adverse events were evaluated every 4 weeks. MASI scores declined significantly in groups A and B compared to group C (P < .05). Cream B, containing tranexamic acid, resulted superior to cream A in subjects with hypervascular melasma. No adverse reactions were observed in all groups. Both active creams are safe and effective for melasma and should be selected according to normal or hypervascular type of melasma. Cream B (containing tranexamic acid) should be prescribed instead of cream A (not containing tranexamic acid) to subjects with hypervascular melasma.",2020,MASI scores declined significantly in groups A and B compared to group C (P < .05).,"['Sixty volunteers with melasma', 'subjects with hypervascular melasma']","['Cream B, containing tranexamic acid', 'Cream B (containing tranexamic acid', 'placebo cream containing petrolatum', 'Tranexamic acid', 'tranexamic acid']","['Melasma Areas and Severity Index', 'MASI) score, melanin index (MI) and adverse events', 'adverse reactions', 'safety and efficacy', 'safe and effective for melasma', 'MASI scores']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}]","[{'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0031262', 'cui_str': 'Petrolatum'}]","[{'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0025196', 'cui_str': 'Melanins'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}]",60.0,0.0316346,MASI scores declined significantly in groups A and B compared to group C (P < .05).,"[{'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Fioranelli', 'Affiliation': 'Department of Nuclear Physics, Sub-Nuclear and Radiation, G. Marconi University, Rome, Italy.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Jafferany', 'Affiliation': 'Central Michigan University College of Medicine, Saginaw, Michigan, USA.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Wollina', 'Affiliation': 'Department of Dermatology and Allergology, Städtisches Klinikum Dresden, Dresden, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tirant', 'Affiliation': 'Unit of Dermatology and Regenerative Medicine, G. Marconi University, Rome, Italy.'}, {'ForeName': 'Nguyen', 'Initials': 'N', 'LastName': 'Van Thuong', 'Affiliation': 'Vietnam National Hospital of Dermatology and Venereology, Hanoi, Vietnam.'}, {'ForeName': 'Torello', 'Initials': 'T', 'LastName': 'Lotti', 'Affiliation': 'Unit of Dermatology and Regenerative Medicine, G. Marconi University, Rome, Italy.'}]",Dermatologic therapy,['10.1111/dth.13300']
809,31183919,Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis: The PRoMPT BOLUS Randomized Controlled Trial Pilot Feasibility Study.,"BACKGROUND


Resuscitation with crystalloid fluid is a cornerstone of pediatric septic shock treatment. However, the optimal type of crystalloid fluid is unknown. We aimed to determine the feasibility of conducting a pragmatic randomized trial to compare balanced (lactated Ringer's [LR]) with 0.9% normal saline (NS) fluid resuscitation in children with suspected septic shock.
METHODS


Open-label pragmatic randomized controlled trial at a single academic children's hospital from January to August 2018. Eligible patients were >6 months to <18 years old who were treated in the emergency department for suspected septic shock, operationalized as blood culture, parenteral antibiotics, and fluid resuscitation for abnormal perfusion. Screening, enrollment, and randomization were carried out by the clinical team as part of routine care. Patients were randomized to receive either LR or NS for up to 48 hours following randomization. Other than fluid type, all treatment decisions were at the clinical team's discretion. Feasibility outcomes included proportion of eligible patients enrolled, acceptability of enrollment via the U.S. federal exception from informed consent (EFIC) regulations, and adherence to randomized study fluid administration.
RESULTS


Of 59 eligible patients, 50 (85%) were enrolled and randomized. Twenty-four were randomized to LR and 26 to NS. Only one (2%) of 44 patients enrolled using EFIC withdrew before study completion. Total median (interquartile range [IQR]) crystalloid fluid volume received during the intervention window was 107 (60 to 155) mL/kg and 98 (63 to 128) mL/kg in the LR and NS arms, respectively (p = 0.50). Patients randomized to LR received a median (IQR) of only 20% (13 to 32) of all study fluid as NS compared to 99% (64% to 100%) of study fluid as NS in the NS arm (absolute difference = 79%, 95% CI = 48% to 85%).
CONCLUSIONS


A pragmatic study design proved feasible to study comparative effectiveness of LR versus NS fluid resuscitation for pediatric septic shock.",2019,"Total median crystalloid fluid volume received during the intervention window was 107 (IQR 60, 155) mL/kg and 98 (IQR 63, 128) mL/kg in the LR and NS arms, respectively (p=0.50).","['Eligible patients were >6 months to <18 years-old who were treated in the emergency department for suspected septic shock, operationalized as blood culture, parenteral antibiotics, and fluid resuscitation for abnormal perfusion', 'children with suspected septic shock', 'Sepsis', '59 eligible patients, 50 (85%) were enrolled and randomized', ""single academic children's hospital from January - August 2018"", 'pediatric septic shock', '44 patients enrolled using EFIC withdrew before study completion']","['LR versus NS fluid resuscitation', 'LR', ""balanced (lactated Ringer's [LR]) with 0.9% normal saline (NS) fluid resuscitation"", 'LR or NS', 'Balanced versus nOrmaL Saline FlUid']",['Total median crystalloid fluid volume'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C0200949', 'cui_str': 'Blood Culture Test'}, {'cui': 'C4522267', 'cui_str': 'Parenteral (intended site)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0073385', 'cui_str': ""Hartmann's Solution""}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0439166', 'cui_str': '% normal (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",44.0,0.510377,"Total median crystalloid fluid volume received during the intervention window was 107 (IQR 60, 155) mL/kg and 98 (IQR 63, 128) mL/kg in the LR and NS arms, respectively (p=0.50).","[{'ForeName': 'Fran', 'Initials': 'F', 'LastName': 'Balamuth', 'Affiliation': ""Department of Pediatrics, Division of Emergency Medicine, Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.""}, {'ForeName': 'Marlena', 'Initials': 'M', 'LastName': 'Kittick', 'Affiliation': ""Department of Pediatrics, Division of Emergency Medicine, Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'McBride', 'Affiliation': ""Department of Pediatrics, Division of Emergency Medicine, Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.""}, {'ForeName': 'Ashley L', 'Initials': 'AL', 'LastName': 'Woodford', 'Affiliation': ""Department of Pediatrics, Division of Emergency Medicine, Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Vestal', 'Affiliation': ""Department of Pediatrics, Division of Emergency Medicine, Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.""}, {'ForeName': 'T Charles', 'Initials': 'TC', 'LastName': 'Casper', 'Affiliation': 'Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Metheney', 'Affiliation': 'Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': ""Department of Anesthesiology and Critical Care, Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.""}, {'ForeName': 'Natalie J', 'Initials': 'NJ', 'LastName': 'Atkin', 'Affiliation': ""Department of Anesthesiology and Critical Care, Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.""}, {'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Baren', 'Affiliation': ""Department of Pediatrics, Division of Emergency Medicine, Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.""}, {'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Dean', 'Affiliation': 'Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Kuppermann', 'Affiliation': 'Department of Emergency Medicine, University of California, Davis Health, Sacramento, CA.'}, {'ForeName': 'Scott L', 'Initials': 'SL', 'LastName': 'Weiss', 'Affiliation': ""Pediatric Sepsis Program, Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.""}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.13815']
810,32162662,"Using more frequent haemodialysis to manage volume overload in dialysis patients with heart failure, obesity or pregnancy.","Managing dialysis in patients with heart failure, pregnancy or obesity is complex. More frequent haemodialysis 5-6 days/week in randomized clinical trials has shown benefits for controlling volume overload, blood pressure and phosphorus, reducing left ventricular hypertrophy (LVH), and improving patient tolerance to therapy. Therapy prescriptions were guided by volume of urea cleared, time-integrated fluid loading control and increased phosphate-β2 microglobulin removal, with greater treatment frequency to address clinical efficacy targets. Case studies in all three categories show that treatment with more frequent haemodialysis in low-dialysate flow systems (Qd <200 mL/min, dialysate of 25-30 L/session, 5-7 days/week for 2.5-3.0 h/session) improves control of heart failure. In pregnancy, treatment 7 days/week with 30 L and 3 h/session of dialysis enabled successful delivery of infants at 32-34 weeks, with all doing well 2-5 years after birth. Obese patients with a body mass index (BMI) >35 achieved control of volume, blood pressure and uraemic symptoms compared to their prior 3 times/week in-centre haemodialysis. Greater application of more frequent haemodialysis should be considered, particularly in high-risk populations, to improve clinical care.",2020,">35 achieved control of volume, blood pressure and uraemic symptoms compared to their prior 3 times/week in-centre haemodialysis.","['Obese patients with a body mass index (BMI', 'patients with heart failure, pregnancy or obesity is complex', 'dialysis patients with heart failure, obesity or pregnancy']",[],"['control of heart failure', 'control of volume, blood pressure and uraemic symptoms']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}]",[],"[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0159828,">35 achieved control of volume, blood pressure and uraemic symptoms compared to their prior 3 times/week in-centre haemodialysis.","[{'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Sangala', 'Affiliation': 'Wessex Kidney Centre, Portsmouth, UK.'}, {'ForeName': 'Maxence', 'Initials': 'M', 'LastName': 'Ficheux', 'Affiliation': 'Department of Nephrology, CHU de Caen, Caen, France.'}, {'ForeName': 'Hafedh', 'Initials': 'H', 'LastName': 'Fessi', 'Affiliation': 'Department of Nephrology, Hospital Tenon, Paris, France.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Borman', 'Affiliation': 'Wessex Kidney Centre, Portsmouth, UK.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Collins', 'Affiliation': 'Fresenius Medical Care, Boston, MA, USA.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfaa020']
811,31650217,18 F-FDG PET-MR enterography in predicting histological active disease using the Nancy index in ulcerative colitis: a randomized controlled trial.,"PURPOSE


To evaluate the diagnostic performance of PET-MR enterography in detecting histological active inflammation in patients with ulcerative colitis and the impact of bowel purgation on diagnostic accuracies of PET-MR parameters.
METHODS


Fifty patients were enrolled in this randomized controlled trial (clinicaltrials.gov [NCT03781284]). Forty patients were randomized in two study arms, in which bowel purgation was performed either before or after PET-MR enterography. All patients underwent ileocolonoscopy with mucosal biopsies after PET-MR within 24 h. Diagnostic performance of MR morphological parameters (MRmorph), diffusion-weighted imaging (DWI), and PET in detecting histological inflammation determined by the Nancy index was compared with each other and between study arms. Correlation between PET and histological inflammatory severity was calculated.
RESULTS


In study arm without previous bowel purgation, SUV max  ratio of bowel segment (relative to SUV max  of the liver) facilitated the highest specificity and diagnostic accuracy compared with MRmorph and DWI. Bowel cleansing led to markedly increased metabolic activity of bowel segments, resulting in significantly reduced specificity of PET compared with study arm without purgation (0.808 vs. 0.966, p = 0.007, respectively). Inter-observer concordance for assessing MRmorph was clearly increased after bowel cleansing (Cohen's κ, 0.847 vs. 0.665; p = 0.013, respectively), though diagnostic performance of MRmorph was not significantly improved. Our findings suggested that the change of metabolic status was mainly associated with the grade of neutrophil infiltrate and less dependent on chronic infiltrate.
CONCLUSION


PET-MR enterography was an excellent non-invasive diagnostic method in the assessment of histological active inflammation in ulcerative colitis without the need of previous bowel purgation.
TRIAL REGISTRATION


https://clinicaltrials.gov/ct2/show/NCT03781284.",2020,"PET-MR enterography was an excellent non-invasive diagnostic method in the assessment of histological active inflammation in ulcerative colitis without the need of previous bowel purgation.
","['Forty patients', 'patients with ulcerative colitis', 'ulcerative colitis', 'Fifty patients']","['PET-MR enterography', 'ileocolonoscopy', '18 F-FDG PET-MR enterography']","['specificity of PET', 'diagnostic performance of MRmorph', 'Diagnostic performance of MR morphological parameters (MRmorph), diffusion-weighted imaging (DWI), and PET in detecting histological inflammation', 'metabolic activity of bowel segments']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009324', 'cui_str': 'Inflammatory Bowel Disease, Ulcerative Colitis Type'}]","[{'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0302995', 'cui_str': '18F radioisotope'}]","[{'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}]",50.0,0.370516,"PET-MR enterography was an excellent non-invasive diagnostic method in the assessment of histological active inflammation in ulcerative colitis without the need of previous bowel purgation.
","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Diagnostic and Interventional Radiology and Neuroradiology, University Hospital Essen, University of Duisburg-Essen, Hufelandstrasse 55, 45147, Essen, Germany. yan.li@uk-essen.de.'}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Schaarschmidt', 'Affiliation': 'Department of Diagnostic and Interventional Radiology and Neuroradiology, University Hospital Essen, University of Duisburg-Essen, Hufelandstrasse 55, 45147, Essen, Germany.'}, {'ForeName': 'Lale', 'Initials': 'L', 'LastName': 'Umutlu', 'Affiliation': 'Department of Diagnostic and Interventional Radiology and Neuroradiology, University Hospital Essen, University of Duisburg-Essen, Hufelandstrasse 55, 45147, Essen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Forsting', 'Affiliation': 'Department of Diagnostic and Interventional Radiology and Neuroradiology, University Hospital Essen, University of Duisburg-Essen, Hufelandstrasse 55, 45147, Essen, Germany.'}, {'ForeName': 'Aydin', 'Initials': 'A', 'LastName': 'Demircioglu', 'Affiliation': 'Department of Diagnostic and Interventional Radiology and Neuroradiology, University Hospital Essen, University of Duisburg-Essen, Hufelandstrasse 55, 45147, Essen, Germany.'}, {'ForeName': 'Anna Katharina', 'Initials': 'AK', 'LastName': 'Koch', 'Affiliation': 'Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, University of Duisburg-Essen, Am Deimelsberg 34a, 45276, Essen, Germany.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Martin', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, University Hospital Dusseldorf, Moorenstraße 5, 40225, Düsseldorf, Germany.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Herrmann', 'Affiliation': 'Department of Nuclear Medicine, University Hospital Essen, University of Duisburg-Essen, Hufelandstrasse 55, 45147, Essen, Germany.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Juette', 'Affiliation': 'Department of Pathology, Ruhr-Universität Hospital Bochum, Bürkle-de-la-Camp-Platz 1, 44789, Bochum, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Tannapfel', 'Affiliation': 'Department of Pathology, Ruhr-Universität Hospital Bochum, Bürkle-de-la-Camp-Platz 1, 44789, Bochum, Germany.'}, {'ForeName': 'Jost', 'Initials': 'J', 'LastName': 'Langhorst', 'Affiliation': 'Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, University of Duisburg-Essen, Am Deimelsberg 34a, 45276, Essen, Germany.'}]",European journal of nuclear medicine and molecular imaging,['10.1007/s00259-019-04535-w']
812,32192739,Reply to Comment on: Conbercept for Treatment of Neovascular Age-Related Macular Degeneration: Results of the Randomized Phase 3 PHOENIX Study.,,2020,,['Neovascular Age-Related Macular Degeneration'],['Conbercept'],[],"[{'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}]","[{'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}]",[],,0.0180722,,"[{'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Shanghai, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Shanghai, China.'}, {'ForeName': 'Peter K', 'Initials': 'PK', 'LastName': 'Kaiser', 'Affiliation': 'Cleveland, Ohio.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Rosenfeld', 'Affiliation': 'Miami, Florida.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Heier', 'Affiliation': 'Boston, Massachusetts.'}]",American journal of ophthalmology,['10.1016/j.ajo.2019.12.007']
813,32188310,Transition of care of stable ischaemic heart disease patients from tertiary to primary care with telemedicine support: Randomized noninferiority clinical trial.,"INTRODUCTION


Evidence of telehealth for chronic disease management is scarce and contradictory.
OBJECTIVES


We aimed to evaluate the safety and efficacy of teleconsultations as support in the care transition of patients with stable coronary artery disease (CAD) from tertiary to primary care.
METHODS


A randomized noninferiority clinical trial was undertaken in patients with CAD from a tertiary hospital in a middle-income country. Patients with functional angina class 1 or 2 and meeting discharge criteria were randomized to remain in the cardiology outpatient clinic for 12 months (control group, CG) or continue follow-up in a primary care unit with clinical support via telemedicine (intervention group, IG). The primary outcome was the maintenance of the functional angina class after 12 months. Secondary outcomes included control of risk factors and clinical outcomes.
RESULTS


In total 271 patients (mean age, 66 years) were included; 81.1% and 91% of the IG and CG, respectively, maintained stable angina symptoms, thus noninferiority could not be shown between the groups. Regarding emergency room visits at 1 year, the IG (7.6%) was noninferior to the CG (6.0%) (absolute difference, 1.6%; noninferiority margin (NIM), -4.8% to 8.2%). For control of risk factors, 30.7% and 29.6% of the IG and CG, respectively, had blood pressure <130/80 mmHg (absolute difference, 1.1%; NIM, -10.5% to 12.8%), and 48.9% and 33.3% of diabetic patients in the IG and CG, respectively, had glycated haemoglobin <7% (absolute difference, 15.6%; NIM, -6.8% to 36%).
CONCLUSIONS


In our study, the difference in the patients' angina functional class did not result in greater seeking of emergency care, supporting that discharge from the outpatient clinic with telemedicine is safe for patients with stable CAD treated at the tertiary level. The control of risk factors in these patients was noninferior to patients followed up in primary care. ClinicalTrials.gov (NCT02489565).",2020,,['stable ischaemic heart disease patients from tertiary to primary care with telemedicine support'],[],[],"[{'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]",[],[],,0.166239,,"[{'ForeName': 'Karen B', 'Initials': 'KB', 'LastName': 'Ruschel', 'Affiliation': 'Federal University of Rio Grande do Sul (Universidade Federal do Rio Grande do Sul - UFRGS).'}, {'ForeName': 'Dimitris Rv', 'Initials': 'DR', 'LastName': 'Rados', 'Affiliation': 'Hospital de Clínicas de Porto Alegre - HCPA.'}, {'ForeName': 'Mariana V', 'Initials': 'MV', 'LastName': 'Furtado', 'Affiliation': 'Hospital de Clínicas de Porto Alegre - HCPA.'}, {'ForeName': ""Joanna d'Arc L"", 'Initials': 'JDL', 'LastName': 'Batista', 'Affiliation': 'Federal University of Fronteira Sul (Universidade Federal da Fronteira Sul - UFFS).'}, {'ForeName': 'Natan', 'Initials': 'N', 'LastName': 'Katz', 'Affiliation': 'Federal University of Rio Grande do Sul (Universidade Federal do Rio Grande do Sul - UFRGS).'}, {'ForeName': 'Erno', 'Initials': 'E', 'LastName': 'Harzheim', 'Affiliation': 'Federal University of Rio Grande do Sul (Universidade Federal do Rio Grande do Sul - UFRGS).'}, {'ForeName': 'Carisi A', 'Initials': 'CA', 'LastName': 'Polanczyk', 'Affiliation': 'Federal University of Rio Grande do Sul (Universidade Federal do Rio Grande do Sul - UFRGS).'}]",Journal of telemedicine and telecare,['10.1177/1357633X20906648']
814,31886693,Values clarification and parental decision making about newborn genomic sequencing.,"OBJECTIVE


Using an online decision aid developed to support parental decision making about newborn genomic sequencing, we tested whether adding a values clarification exercise to educational content would improve decision making outcomes and influence intention to pursue genomic sequencing. We also examined whether the effect of values clarification varied depending on one's health literacy level.
METHOD


In an online experiment, women and men aged 18 to 44 who were either pregnant or had a pregnant partner, were currently trying to get pregnant, or were preparing for a pregnancy within the next 2 years were randomly assigned to complete either a decision aid with educational information about newborn genomic sequencing or a decision aid with the same educational information and a values clarification exercise.
RESULTS


Of the 1,000 participants who completed the decision aid, those who completed the values clarification exercise reported less decision regret,  F (1, 995) = 6.19,  p  = .01, and were clearer about their personal values,  F (1, 995) = 6.39,  p  = .01. Moderation analyses revealed that the benefit of values clarification on decisional conflict was particularly evident among participants with lower health literacy,  B  = -3.94,  SE  = 1.67,  t  = -2.36,  p  = .018. There was not a significant moderation effect of health literacy and decision aid condition on decision regret.
CONCLUSIONS


Adding a values clarification exercise to decision aids for parents making decisions about genomic sequencing may improve the decision-making experience and provide some benefit to individuals with lower health literacy. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,Adding a values clarification exercise to decision aids for parents making decisions about genomic sequencing may improve the decision-making experience and provide some benefit to individuals with lower health literacy.,"['1,000 participants who completed the decision aid', 'women and men aged 18 to 44 who were either pregnant or had a pregnant partner, were currently trying to get pregnant, or were preparing for a pregnancy within the next 2 years', 'individuals with lower health literacy']",['decision aid with educational information about newborn genomic sequencing or a decision aid with the same educational information and a values clarification exercise'],['decisional conflict'],"[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0420843', 'cui_str': 'Trying to conceive (finding)'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}]","[{'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0887950', 'cui_str': 'Genomics'}, {'cui': 'C0150401', 'cui_str': 'Values clarification'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}]",1000.0,0.0387819,Adding a values clarification exercise to decision aids for parents making decisions about genomic sequencing may improve the decision-making experience and provide some benefit to individuals with lower health literacy.,"[{'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Peinado', 'Affiliation': 'Center for Communication Science.'}, {'ForeName': 'Ryan S', 'Initials': 'RS', 'LastName': 'Paquin', 'Affiliation': 'Center for Communication Science.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Rini', 'Affiliation': 'John Theurer Cancer Center.'}, {'ForeName': 'Myra', 'Initials': 'M', 'LastName': 'Roche', 'Affiliation': 'University of North Carolina School of Medicine.'}, {'ForeName': 'Rita M', 'Initials': 'RM', 'LastName': 'Butterfield', 'Affiliation': 'University of North Carolina School of Medicine.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Berg', 'Affiliation': 'University of North Carolina School of Medicine.'}, {'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Powell', 'Affiliation': 'University of North Carolina School of Medicine.'}, {'ForeName': 'Donald B', 'Initials': 'DB', 'LastName': 'Bailey', 'Affiliation': 'Center for Newborn Screening, Ethics, and Disability Studies.'}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Lewis', 'Affiliation': 'Center for Communication Science.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000829']
815,31071535,Experimental muscle pain of the vastus medialis reduces knee joint extensor torque and alters quadriceps muscle contributions as revealed through musculoskeletal modeling.,"BACKGROUND


Voluntary activation deficit of the quadriceps muscle group is a common symptom in populations with knee joint injury. Musculoskeletal modeling and simulations can improve our understanding of pathological conditions; however, they are mathematically complex which can limit their clinical application. A practical subject-specific modeling framework is introduced to evaluate knee extensor inhibition and muscle force contributions to isometric knee joint torques in healthy adults with and without experimentally induced quadriceps muscle pain.
METHODS


A randomized cross-over placebo controlled study design was used. Subject-specific maximum knee joint extension torque and quadriceps electromyographic data from 13 uninjured young adults were combined in a modeling framework to determine optimal muscle strength scaling parameters and ideal torque. Strength deficit ratios (experimental torque/ideal torque) and individual muscle contribution to experimental torque was computed before and after intramuscular hypertonic (pain inducing) and isotonic (sham) saline was injected to the vastus medialis.
FINDINGS


Decreased experimental knee extension torque (-8%) and vastus medialis electromyography (-26%) amplitude pre- to post- hypertonic injection was observed. Correspondingly, significant decreases in the knee extensor strength deficit ratio (-18%) and percent contribution of vastus medialis to experimental torque (-24%) was observed pre- to post- hypertonic injection. No differences were observed with isotonic injections, confirming the validity of the model.
INTERPRETATION


Our practical method to estimate strength ratios can be easily implemented within a musculoskeletal modeling framework to improve the validity of model estimates. This, in turn, can increase our understanding of the relationship between neuromuscular deficits and functional outcomes in patient populations.",2019,"FINDINGS


Decreased experimental knee extension torque (-8%) and vastus medialis electromyography (-26%) amplitude pre- to post- hypertonic injection was observed.","['populations with knee joint injury', 'healthy adults with and without experimentally induced quadriceps muscle pain', '13 uninjured young adults']","['intramuscular hypertonic (pain inducing) and isotonic (sham) saline', 'placebo']","['vastus medialis electromyography', 'percent contribution of vastus medialis to experimental torque', 'experimental knee extension torque', 'knee extensor strength deficit ratio', 'Strength deficit ratios']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0022745', 'cui_str': 'Superior Tibiofibular Joint'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0224445', 'cui_str': 'Vastus Medialis'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",13.0,0.0224007,"FINDINGS


Decreased experimental knee extension torque (-8%) and vastus medialis electromyography (-26%) amplitude pre- to post- hypertonic injection was observed.","[{'ForeName': 'Teresa E', 'Initials': 'TE', 'LastName': 'Flaxman', 'Affiliation': 'School of Rehabilitation Sciences, University of Ottawa, 451 Smyth Rd, Ottawa, ON K1H 8M5, Canada. Electronic address: teresa.flaxman@gmail.com.'}, {'ForeName': 'Mohammad S', 'Initials': 'MS', 'LastName': 'Shourijeh', 'Affiliation': 'School of Rehabilitation Sciences, University of Ottawa, 451 Smyth Rd, Ottawa, ON K1H 8M5, Canada. Electronic address: msharifs@uwaterloo.ca.'}, {'ForeName': 'Tine', 'Initials': 'T', 'LastName': 'Alkjær', 'Affiliation': 'Department of Neuroscience and Pharmacology, University of Copenhagen, Blegdamsvaj 3B, DK-2200 Copenhagen N, Denmark. Electronic address: talkjaer@sund.ku.dk.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Krogsgaard', 'Affiliation': 'Section for Sportstraumatology, Bispebjerg Hospital, Bispebjerg Bakke 23, DK-2400, Copenhagen NV, Denmark. Electronic address: mrk@dadlnet.dk.'}, {'ForeName': 'Erik B', 'Initials': 'EB', 'LastName': 'Simonsen', 'Affiliation': 'Department of Neuroscience and Pharmacology, University of Copenhagen, Blegdamsvaj 3B, DK-2200 Copenhagen N, Denmark. Electronic address: eksn@sund.ku.dk.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Bigham', 'Affiliation': 'School of Human Kinetics, University of Ottawa, 125 University Pr, Ottawa, ON K1N 1A2, Canada. Electronic address: heather.jb@hotmail.com.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Benoit', 'Affiliation': 'School of Rehabilitation Sciences, University of Ottawa, 451 Smyth Rd, Ottawa, ON K1H 8M5, Canada; School of Human Kinetics, University of Ottawa, 125 University Pr, Ottawa, ON K1N 1A2, Canada. Electronic address: dbenoit@uottawa.ca.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2019.04.005']
816,32180507,School-based yoga intervention increases adolescent resilience: a pilot trial.,"Background:  Youth often experience stressors leading to negative long-term outcomes. Enhancing social-emotional attributes is important to foster resiliency to face these challenges. Yoga may enhance social-emotional resiliency among youth. However, research replicating such results in school-settings is limited. This research details an investigation of the effects of the Kripalu Yoga in the Schools (KYIS) intervention integrated into a physical education class among a racially/ethnically diverse student population.  Method:  Middle school sixth grade students ( n  = 23 students; 52% female; mean age = 12.1 years) were either enrolled in physical education class that included KYIS ( n  = 9), or were enrolled in art and music (control condition;  n  = 14). To evaluate effects on student characteristics, self-report questionnaires of social-emotional competence and problem behaviour were administered pre- and post-delivery of the curriculum.  Results:  Students receiving the intervention increased in social-emotional competence over time relative to the control condition. Although promising, results should be interpreted with caution, as students who received the yoga intervention scored significantly lower on social-emotional competence than students in the control group at pre-intervention measurement time point.  Conclusions:  Yoga may improve social-emotional competence among youth and future research should explore the utility of yoga curricula in school settings.",2020,Results:  Students receiving the intervention increased in social-emotional competence over time relative to the control condition.,"['Schools (KYIS) intervention integrated into a physical education class among a racially/ethnically diverse student population', 'Method:  Middle school sixth grade students ( n  = 23 students; 52% female; mean age = 12.1 years) were either enrolled in physical education class that included KYIS ( n  = 9), or were enrolled in art and music (control condition;  n  = 14', 'youth']","['School-based yoga intervention', 'Kripalu Yoga']","['social-emotional resiliency', 'student characteristics, self-report questionnaires of social-emotional competence and problem behaviour', 'social-emotional competence', 'adolescent resilience']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0031805', 'cui_str': 'Physical Education'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C0205440', 'cui_str': 'Sixth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0233514', 'cui_str': 'Behavioral Problem'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",,0.0162289,Results:  Students receiving the intervention increased in social-emotional competence over time relative to the control condition.,"[{'ForeName': 'Joshua C', 'Initials': 'JC', 'LastName': 'Felver', 'Affiliation': 'Psychology Department, Syracuse University, Syracuse NY, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Razza', 'Affiliation': 'Psychology Department, Syracuse University, Syracuse NY, USA.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Morton', 'Affiliation': 'Psychology Department, Syracuse University, Syracuse NY, USA.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Clawson', 'Affiliation': 'Psychology Department, Syracuse University, Syracuse NY, USA.'}, {'ForeName': 'Rebecca Shaffer', 'Initials': 'RS', 'LastName': 'Mannion', 'Affiliation': 'Psychology Department, Syracuse University, Syracuse NY, USA.'}]",Journal of child and adolescent mental health,['10.2989/17280583.2019.1698429']
817,32040014,Secondary Analysis of the Efficacy and Safety Trial Data of the Tetravalent Dengue Vaccine in Children and Adolescents in Colombia.,"BACKGROUND


The efficacy of the recombinant, live, attenuated, tetravalent dengue vaccine (CYD-TDV) against virologically-confirmed dengue (VCD) has been documented in a phase 3 trial in Latin America (CYD15, NCT01374516). This is a descriptive secondary analysis of the efficacy and safety of CYD-TDV in participants from Colombia.
METHODS


Data from 9740 Colombian participants 9-16 years of age who were randomized 2:1 to receive CYD-TDV or placebo were assessed to describe the vaccine efficacy of CYD-TDV against VCD and severe VCD. Estimation was made of the relative risk (RR) for hospitalized VCD cases and severe hospitalized VCD cases after the first dose of CYD-TDV, as well as a description of the incidence of hospitalized dengue from the start of the study and per year of the study until study completion.
RESULTS


During the active phase of the trial in Colombia, the efficacy of CYD-TDV was 67.5% [95% confidence interval (CI): 58.3-74.7] against symptomatic VCD due to any serotype from injection 1 (month 0) to 25 months postinjection 1. Over 6 years, the RR across all 4 serotypes was 0.166 (95% CI: 0.09-0.29) in hospitalized VCD patients and 0.154 (95% CI: 0.04-0.50) in patients with severe hospitalized VCD.
CONCLUSIONS


Analysis of the data from Colombia mimics the efficacy observed in CYD15 during the active surveillance follow-up (25 months), but with a sustained beneficial RR for dengue hospitalizations on the subsequent years of follow-up. In Colombia, where seroprevalence has been demonstrated to be high in several regions of the country, CYD-TDV is a useful tool to consider as part of an integrated control strategy against endemic dengue, a disease with a high economic impact on the health system.",2020,"Over 6 years, the RR across all 4 serotypes was 0.166","['participants from Colombia', 'Data from 9740 Colombian participants 9-16 years of age who', 'Children and Adolescents in Colombia']","['CYD-TDV', 'Tetravalent Dengue Vaccine', 'CYD-TDV or placebo']","['symptomatic VCD', 'vaccine efficacy of CYD-TDV against VCD and severe VCD']","[{'cui': 'C3245499', 'cui_str': 'Colombia'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C1548477', 'cui_str': 'Dengue Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",9740.0,0.2911,"Over 6 years, the RR across all 4 serotypes was 0.166","[{'ForeName': 'Humberto', 'Initials': 'H', 'LastName': 'Reynales', 'Affiliation': 'From the Centro de Atención e Investigación Médica - CAIMED, Bogotá, Colombia.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Carrasquilla', 'Affiliation': 'Fundación Santa Fe de Bogotá, Bogotá, Colombia.'}, {'ForeName': 'Betzana', 'Initials': 'B', 'LastName': 'Zambrano', 'Affiliation': 'Sanofi Pasteur Global Clinical Sciences, Montevideo, Uruguay.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Cortés S', 'Affiliation': 'Sanofi Global Head Medical, Bogotá, Colombia.'}, {'ForeName': 'Tifany', 'Initials': 'T', 'LastName': 'Machabert', 'Affiliation': ""Sanofi Pasteur Global Clinical Programs, Marcy L'Étoile, France.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Jing', 'Affiliation': 'Biostatistics and Programming, Clinical Scientific Operations, Sanofi, Beijing, China.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Pallardy', 'Affiliation': ""Sanofi Pasteur Global Clinical Programs, Marcy L'Étoile, France.""}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Haney', 'Affiliation': 'Sanofi Pasteur Global Pharmacovigilance, Swiftwater, PA, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Faccini', 'Affiliation': 'From the Centro de Atención e Investigación Médica - CAIMED, Bogotá, Colombia.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Quintero', 'Affiliation': 'Fundación Santa Fe de Bogotá, Bogotá, Colombia.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Noriega', 'Affiliation': 'Sanofi Pasteur Global Clinical Sciences, Swiftwater, PA, USA.'}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000002580']
818,31605307,"Comparison of Billroth I, Billroth II, and Roux-en-Y Reconstruction After Totally Laparoscopic Distal Gastrectomy: A Randomized Controlled Study.","INTRODUCTION


This study aimed to explore the efficacy of delta-shaped Billroth I anastomosis in totally laparoscopic distal gastrectomy for digestive tract reconstruction, and provide clinical data for determining the most appropriate digestive tract reconstruction method after distal gastrectomy.
METHODS


This was a prospective randomized controlled study. A total of 180 patients were randomly and prospectively selected from Renmin Hospital of Wuhan University by random number table. These patients were randomly divided into three groups: Billroth I group, Billroth II group, and Roux-en-Y (RY) group.
RESULTS


There were significant differences in resection margin, blood nutrition, and the number of postoperative complications among these three groups (P < 0.05). Furthermore, the resection margin, blood nutrition status, and immunization of patients in these three groups were determined. Compared to the other groups, the RY group was better in terms of hematologic status, immunological index, and postoperative complications.
CONCLUSION


Delta-shaped Billroth I anastomosis in totally laparoscopic distal gastrectomy for digestive tract reconstruction is simple and easy to perform, and has an advantage in postoperative gastrointestinal function recovery. RY reconstruction is superior to Billroth I and Billroth II in terms of postoperative complications.",2019,"Compared to the other groups, the RY group was better in terms of hematologic status, immunological index, and postoperative complications.
","['180 patients were randomly and prospectively selected from Renmin Hospital of Wuhan University by random number table', 'totally laparoscopic distal gastrectomy for digestive tract reconstruction']","['Totally Laparoscopic Distal Gastrectomy', 'Billroth\xa0I group, Billroth\xa0II group, and Roux-en-Y (RY) group', 'Delta-shaped Billroth', 'laparoscopic distal gastrectomy', 'delta-shaped Billroth\xa0I anastomosis', 'Billroth', 'Roux-en-Y Reconstruction']","['hematologic status, immunological index, and postoperative complications', 'resection margin, blood nutrition status, and immunization', 'resection margin, blood nutrition, and the number of postoperative complications']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1706074', 'cui_str': 'Table'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal Tract'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}]","[{'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0192440', 'cui_str': 'Billroth I Operation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0192444', 'cui_str': 'Billroth II Procedure'}, {'cui': 'C0002804', 'cui_str': 'Roux-en-Y Anastomosis'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}]","[{'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0229985', 'cui_str': 'Margins of Excision'}, {'cui': 'C0005768'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",180.0,0.0143522,"Compared to the other groups, the RY group was better in terms of hematologic status, immunological index, and postoperative complications.
","[{'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Ren', 'Affiliation': 'Department of General Surgery, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Wei-Xing', 'Initials': 'WX', 'LastName': 'Wang', 'Affiliation': 'Department of General Surgery, Renmin Hospital of Wuhan University, Wuhan, China. weixingwang_dr@163.com.'}]",Advances in therapy,['10.1007/s12325-019-01104-3']
819,31045455,Effects of Arteriovenous Fistula Ligation on Cardiac Structure and Function in Kidney Transplant Recipients.,"BACKGROUND


Cardiovascular morbidity and mortality remain high in recipients of a kidney transplant. The persistence of a patent arteriovenous fistula (AVF) after transplantation may contribute to ongoing maladaptive cardiovascular remodeling. The ability to reverse this maladaptive remodeling by ligation of this AVF is unknown. We conducted the first randomized controlled trial to evaluate the effect of AVF ligation on cardiac structure and function in stable kidney transplant recipients.
METHODS


In this randomized controlled trial, kidney transplant recipients (>12 months after transplantation with stable graft function) were randomized to AVF ligation or no intervention. All participants underwent cardiac magnetic resonance imaging at baseline and at 6 months. The primary outcome was the change in left ventricular (LV) mass. Secondary outcomes included changes in LV volumes, left and right atrial areas, LV ejection fraction, NT-proBNP (N-terminal pro-B-type natriuretic peptide) levels, cardiac output/index, brachial flows (ipsilateral to AVF), and pulmonary artery velocity.
RESULTS


A total of 93 patients were screened, of whom 64 met the inclusion criteria and were randomized to the AVF ligation (n=33) or control (n=31) group. Fifty-four participants completed the study: 27 in the AVF ligation group and 27 in the control group. On the second cardiac magnetic resonance scan, a mean decrease of 22.1 g (95% CI, 15.0-29.1) was observed in LV mass in the AVF ligation group compared with a small increase of 1.2 g (95% CI, -4.8 to 7.2) in the control group ( P<0.001). Significant decreases in LV end-diastolic volumes, LV end-systolic volumes, cardiac output, cardiac index, atrial volumes, and NT-proBNP were also seen in the AVF closure group ( P<0.01). No significant changes were observed in LV ejection fraction ( P=0.93) and pulmonary artery velocity ( P=0.07). No significant complications were noted after AVF ligation. No changes in estimated glomerular filtration rate or systolic and diastolic blood pressures were observed between cardiac magnetic resonance scans.
CONCLUSIONS


Elective ligation of patent AVF in adults with stable kidney transplant function resulted in clinically significant reduction of LV myocardial mass.
CLINICAL TRIAL REGISTRATION


Australian and New Zealand Clinical Trials Registry URL: https://www.anzctr.org.au . Unique Identifier: ACTRN12613001302741.",2019,No significant changes were observed in LV ejection fraction ( P=0.93) and pulmonary artery velocity ( P=0.07).,"['93 patients were screened, of whom 64 met the inclusion criteria', 'Fifty-four participants completed the study: 27 in the AVF ligation group and 27 in the control group', 'adults with stable kidney transplant function', 'recipients of a kidney transplant', 'stable kidney transplant recipients', 'kidney transplant recipients (>12 months after transplantation with stable graft function', 'n=33) or control (n=31) group', 'Kidney Transplant Recipients']","['Arteriovenous Fistula Ligation', 'AVF ligation or no intervention', 'cardiac magnetic resonance imaging', 'AVF ligation']","['Cardiac Structure and Function', 'pulmonary artery velocity', 'estimated glomerular filtration rate or systolic and diastolic blood pressures', 'LV end-diastolic volumes, LV end-systolic volumes, cardiac output, cardiac index, atrial volumes, and NT-proBNP', 'cardiac structure and function', 'LV mass', 'changes in LV volumes, left and right atrial areas, LV ejection fraction, NT-proBNP (N-terminal pro-B-type natriuretic peptide) levels, cardiac output/index, brachial flows (ipsilateral to AVF), and pulmonary artery velocity', 'change in left ventricular (LV) mass', 'LV ejection fraction', 'LV myocardial mass']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0449215', 'cui_str': 'aVF (body structure)'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0189718', 'cui_str': 'Repair of arteriovenous fistula by suture (procedure)'}, {'cui': 'C0449215', 'cui_str': 'aVF (body structure)'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034052', 'cui_str': 'Pulmonary Artery'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C3811844'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index (observable entity)'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass (finding)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0445456', 'cui_str': 'Brachial (qualifier value)'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}, {'cui': 'C0449215', 'cui_str': 'aVF (body structure)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",93.0,0.220665,No significant changes were observed in LV ejection fraction ( P=0.93) and pulmonary artery velocity ( P=0.07).,"[{'ForeName': 'Nitesh N', 'Initials': 'NN', 'LastName': 'Rao', 'Affiliation': 'Adelaide Medical School, University of Adelaide, Australia (N.N.R., S.U., R.P.C., S.P.M., M.I.W., P.T.C.).'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Stokes', 'Affiliation': 'Department of Cardiology (M.B.S., A.R., K.W., K.S.L.T., M.I.W.), Central Adelaide Local Health Network, Australia.'}, {'ForeName': 'Adil', 'Initials': 'A', 'LastName': 'Rajwani', 'Affiliation': 'Department of Cardiology (M.B.S., A.R., K.W., K.S.L.T., M.I.W.), Central Adelaide Local Health Network, Australia.'}, {'ForeName': 'Shahid', 'Initials': 'S', 'LastName': 'Ullah', 'Affiliation': 'Adelaide Medical School, University of Adelaide, Australia (N.N.R., S.U., R.P.C., S.P.M., M.I.W., P.T.C.).'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Williams', 'Affiliation': 'Department of Cardiology (M.B.S., A.R., K.W., K.S.L.T., M.I.W.), Central Adelaide Local Health Network, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'King', 'Affiliation': 'Central Northern Adelaide Renal and Transplantation Service (N.N.R., D.K., E.M., C.H.R., S.O., R.P.C., R.J.F., S.P.M., P.T.C.), Central Adelaide Local Health Network, Australia.'}, {'ForeName': 'Ewan', 'Initials': 'E', 'LastName': 'Macaulay', 'Affiliation': 'Central Northern Adelaide Renal and Transplantation Service (N.N.R., D.K., E.M., C.H.R., S.O., R.P.C., R.J.F., S.P.M., P.T.C.), Central Adelaide Local Health Network, Australia.'}, {'ForeName': 'Christine H', 'Initials': 'CH', 'LastName': 'Russell', 'Affiliation': 'Central Northern Adelaide Renal and Transplantation Service (N.N.R., D.K., E.M., C.H.R., S.O., R.P.C., R.J.F., S.P.M., P.T.C.), Central Adelaide Local Health Network, Australia.'}, {'ForeName': 'Santosh', 'Initials': 'S', 'LastName': 'Olakkengil', 'Affiliation': 'Central Northern Adelaide Renal and Transplantation Service (N.N.R., D.K., E.M., C.H.R., S.O., R.P.C., R.J.F., S.P.M., P.T.C.), Central Adelaide Local Health Network, Australia.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Carroll', 'Affiliation': 'Adelaide Medical School, University of Adelaide, Australia (N.N.R., S.U., R.P.C., S.P.M., M.I.W., P.T.C.).'}, {'ForeName': 'Randall J', 'Initials': 'RJ', 'LastName': 'Faull', 'Affiliation': 'Central Northern Adelaide Renal and Transplantation Service (N.N.R., D.K., E.M., C.H.R., S.O., R.P.C., R.J.F., S.P.M., P.T.C.), Central Adelaide Local Health Network, Australia.'}, {'ForeName': 'Karen S L', 'Initials': 'KSL', 'LastName': 'Teo', 'Affiliation': 'Department of Cardiology (M.B.S., A.R., K.W., K.S.L.T., M.I.W.), Central Adelaide Local Health Network, Australia.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'McDonald', 'Affiliation': 'Adelaide Medical School, University of Adelaide, Australia (N.N.R., S.U., R.P.C., S.P.M., M.I.W., P.T.C.).'}, {'ForeName': 'Matthew I', 'Initials': 'MI', 'LastName': 'Worthley', 'Affiliation': 'Adelaide Medical School, University of Adelaide, Australia (N.N.R., S.U., R.P.C., S.P.M., M.I.W., P.T.C.).'}, {'ForeName': 'P Toby', 'Initials': 'PT', 'LastName': 'Coates', 'Affiliation': 'Adelaide Medical School, University of Adelaide, Australia (N.N.R., S.U., R.P.C., S.P.M., M.I.W., P.T.C.).'}]",Circulation,['10.1161/CIRCULATIONAHA.118.038505']
820,32202330,"A Randomized, Doubled-Blind Clinical Trial on the Effect of Zataria multiflora on Clinical Symptoms, Oxidative Stress, and C-Reactive Protein in COPD Patients.","The effects of Zataria multiflora on clinical symptoms, pulmonary function tests, oxidative stress, and C-reactive protein levels in chronic obstructive pulmonary disease (COPD) patients were evaluated. Forty-five patients were allocated to 3 groups: placebo group and 2 groups that received 3 and 6 mg/kg/day Z. multiflora extract (Z3 and Z6) for 2 months. Clinical symptoms, pulmonary function tests, oxidative stress, and serum C-reactive protein levels were evaluated pretreatment (step 0) and 1 (step I) and 2 (step II) months after treatment. Clinical symptoms including breathlessness and chest wheeze in Z3- and Z6-treated groups and sputum production only in the Z6-treated group were significantly improved 1 and 2 months after treatment compared with baseline values (P < .01 to P < .001). The FEV 1  was significantly increased after 2 months of treatment with Z3 and Z6 (P < .05 to P < .01). Malondialdehyde and nitrite levels were significantly decreased after a 2-month treatment with Z6 compared with step 0 (P < .05 to P < .01). The thiol contents in the Z6 group as well as superoxide dismutase and catalase activities in both groups treated with the extract were significantly increased in step II compared with step 0 (P < .05 to P < .01). The C-reactive protein level at the end of the study was significantly reduced compared with the step 0 in both treated groups (P < .05 for both cases). Two-month treatment with Z. multiflora improved clinical symptoms, pulmonary function tests, oxidative stress, and C-reactive protein in COPD patients. The results suggest that this herbal medicine could be of therapeutic value as a preventive drug for the treatment of COPD.",2020,Malondialdehyde and nitrite levels were significantly decreased after a 2-month treatment with Z6 compared with step 0,"['COPD Patients', 'Forty-five patients', 'chronic obstructive pulmonary disease (COPD) patients']","['3 and 6\xa0mg/kg/day Z. multiflora extract (Z3 and Z6', 'Zataria multiflora', 'placebo']","['C-reactive protein level', 'clinical symptoms, pulmonary function tests, oxidative stress, and C-reactive protein', 'superoxide dismutase and catalase activities', 'FEV 1', 'clinical symptoms, pulmonary function tests, oxidative stress, and C-reactive protein levels', 'Clinical symptoms including breathlessness and chest wheeze', 'Clinical symptoms, pulmonary function tests, oxidative stress, and serum C-reactive protein levels', 'Malondialdehyde and nitrite levels', 'sputum production', 'Clinical Symptoms, Oxidative Stress, and C-Reactive Protein']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319567', 'cui_str': '45'}]","[{'cui': 'C3665414', 'cui_str': 'mg/kg/day'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0069638', 'cui_str': 'orgotein'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C1277266', 'cui_str': 'Serum C reactive protein level'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0028137', 'cui_str': 'Nitrites'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0033268'}]",45.0,0.0246452,Malondialdehyde and nitrite levels were significantly decreased after a 2-month treatment with Z6 compared with step 0,"[{'ForeName': 'Vahideh', 'Initials': 'V', 'LastName': 'Ghorani', 'Affiliation': 'Department of Physiology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Rajabi', 'Affiliation': 'Department of Drug and Food Control, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Mirsadraee', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Islamic Azad University-Mashhad Branch, Mashhad, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Rezaeitalab', 'Affiliation': 'Department of Internal Medicine, Imam Reza Hospital, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Saeideh', 'Initials': 'S', 'LastName': 'Saadat', 'Affiliation': 'Department of Physiology, School of Medicine, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Boskabady', 'Affiliation': 'Department of Physiology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Journal of clinical pharmacology,['10.1002/jcph.1586']
821,32138775,Potential effect of different nutritional labels on food choices among mothers: a study protocol.,"BACKGROUND


The prevalence of non-communicable diseases (NCDs) is increasing in the world. Healthy food choice and adequate physical activity are key factors in preventing NCDs. Food labeling is a strategy that can inform consumers to choose healthier foods at the point of purchase. In this study, we intend to examine the status of existing labels and to clarify their strengths and weaknesses. Then, for the first time in Iran, we will design a type of physical activity equivalent calorie label and will test it on some food groups of packaged products including dairy products, sweetened beverages, cakes, and biscuits.
METHODS


This study will be conducted in two phases. In phase 1, nutrition fact labels and traffic light labels will be assessed through focus group discussions and interviews among different groups of mothers, industrialists and nutrition and food industry specialists as to determine strengths and weaknesses of the current labels on packaged products. Then, the initial layout of the physical activity calorie equivalent label will be drawn with respect to the viewpoints received from mothers. Thereafter, we will include the scientific opinions to it for creating the first draft of our new label. In phase 2, a total of 500 mothers of students 6-12 years old randomly assigned to five groups. The study groups will be as follows: (1) without nutrition label group, (2) current traffic light label group, (3) current traffic light label group in which, a brochure will be used to inform mothers, (4) physical activity calorie equivalent label group, and (5) physical activity calorie equivalent label group in which a brochure will be used to inform mothers. Some samples of dairy products, beverages, cakes, and biscuits will be presented. ANOVA and multiple linear regressions will be used to examine the association between the label type and the main consequence (energy of the selected products) and secondary outcome (time).
DISCUSSION


The effect of the new food labels will be evaluated based on the differences between the calories of selected food groups.
TRIAL REGISTERATION


Iranian Registery of Clinical Trials [IRCT]20,181,002,041,201 N1.",2020,"In phase 1, nutrition fact labels and traffic light labels will be assessed through focus group discussions and interviews among different groups of mothers, industrialists and nutrition and food industry specialists as to determine strengths and weaknesses of the current labels on packaged products.","['mothers', '500 mothers of students 6-12\u2009years old randomly assigned to five groups']","['nutritional labels', 'nutrition label group, (2) current traffic light label group, (3) current traffic light label group in which, a brochure will be used to inform mothers, (4) physical activity calorie equivalent label group, and (5) physical activity calorie equivalent label group']",[],"[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0442664', 'cui_str': 'Traffic light (physical object)'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}]",[],500.0,0.049084,"In phase 1, nutrition fact labels and traffic light labels will be assessed through focus group discussions and interviews among different groups of mothers, industrialists and nutrition and food industry specialists as to determine strengths and weaknesses of the current labels on packaged products.","[{'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Seyedhamzeh', 'Affiliation': 'Department of Community Nutrition [DCN], School of Nutritional Sciences and Dietetics [SNSD], Tehran University of Medical Sciences [TUMS], Tehran, Iran.'}, {'ForeName': 'Saharnaz', 'Initials': 'S', 'LastName': 'Nedjat', 'Affiliation': 'School of Public Health [SPH], TUMS, Tehran, Iran.'}, {'ForeName': 'Hedayat', 'Initials': 'H', 'LastName': 'Hosseini', 'Affiliation': 'Department of Food Sciences & Technology, National Nutrition &Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Shakibazedeh', 'Affiliation': 'Department of Health Education and Promotion, SPH, TUMS, Tehran, Iran.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Viera', 'Affiliation': 'Department of Community and Family Medicine, Duke University, Durham, NC, USA.'}, {'ForeName': 'Ahmadreza', 'Initials': 'A', 'LastName': 'Dorosty Motlagh', 'Affiliation': 'DCN, SNSD, TUMS, No 44, Hojjat-dost Alley, Naderi Street, Keshavarz Boulevard, Tehran, 1416-643931, Iran. dorostim@tums.ac.ir.'}]",BMC public health,['10.1186/s12889-020-8411-8']
822,31529104,Sleep Disturbance Predicts Less Improvement in Pain Outcomes: Secondary Analysis of the SPACE Randomized Clinical Trial.,"OBJECTIVE


Sleep disturbance may limit improvement in pain outcomes if not directly addressed in treatment. Moreover, sleep problems may be exacerbated by opioid therapy. This study examined the effects of baseline sleep disturbance on improvement in pain outcomes using data from the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial, a pragmatic 12-month randomized trial of opioid vs nonopioid medication therapy.
DESIGN


Participants with chronic back pain or hip or knee osteoarthritis pain were randomized to either opioid therapy (N = 120) or nonopioid medication therapy (N = 120).
METHODS


We used mixed models for repeated measures to 1) test whether baseline sleep disturbance scores modified the effect of opioid vs nonopioid treatment on pain outcomes and 2) test baseline sleep disturbance scores as a predictor of less improvement in pain outcomes across both treatment groups.
RESULTS


The tests for interaction of sleep disturbance by treatment group were not significant. Higher sleep disturbance scores at baseline predicted less improvement in Brief Pain Inventory (BPI) interference (β = 0.058, P = 0.0002) and BPI severity (β = 0.026, P = 0.0164).
CONCLUSIONS


Baseline sleep disturbance adversely affects pain response to treatment regardless of analgesic regimen. Recognition and treatment of sleep impairments that frequently co-occur with pain may optimize outcomes.",2020,"Higher sleep disturbance scores at baseline predicted less improvement in Brief Pain Inventory (BPI) interference (β = 0.058, P = 0.0002) and BPI severity (β = 0.026, P = 0.0164).
",['Participants with chronic back pain or hip or knee osteoarthritis pain'],"['opioid vs nonopioid medication therapy', 'opioid vs nonopioid treatment', 'opioid therapy (N\u2009=\u2009120) or nonopioid medication therapy (N\u2009=\u2009120']","['pain outcomes', 'sleep disturbance', 'Higher sleep disturbance scores', 'Brief Pain Inventory (BPI) interference', 'pain response', 'BPI severity', 'pain outcomes and 2) test baseline sleep disturbance scores']","[{'cui': 'C0740418', 'cui_str': 'Chronic back pain (finding)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0013216', 'cui_str': 'Pharmacotherapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",,0.122586,"Higher sleep disturbance scores at baseline predicted less improvement in Brief Pain Inventory (BPI) interference (β = 0.058, P = 0.0002) and BPI severity (β = 0.026, P = 0.0164).
","[{'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Koffel', 'Affiliation': 'Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, Minnesota.'}, {'ForeName': 'Allyson M', 'Initials': 'AM', 'LastName': 'Kats', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Kroenke', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Bair', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Gravely', 'Affiliation': 'Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, Minnesota.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'DeRonne', 'Affiliation': 'Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, Minnesota.'}, {'ForeName': 'Melvin T', 'Initials': 'MT', 'LastName': 'Donaldson', 'Affiliation': 'University of Minnesota Medical School, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Goldsmith', 'Affiliation': 'Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, Minnesota.'}, {'ForeName': 'Siamak', 'Initials': 'S', 'LastName': 'Noorbaloochi', 'Affiliation': 'Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, Minnesota.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Krebs', 'Affiliation': 'Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, Minnesota.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz221']
823,32187663,Perianal block with ropivacaine as a supplement to anaesthesia in proctological surgery: double-blind randomized placebo-controlled trial (PERCEPT).,"BACKGROUND


The benefit of a perianal block as an adjunct to general or regional anaesthesia is debated. This RCT aimed to compare pain at 24 h and up to 14 days after proctological surgery in patients with and without a perianal block.
METHODS


Between January 2018 and April 2019, patients were allocated to receive a perianal block with ropivacaine or placebo as an adjunct to anaesthesia. Patients, surgeons and assessors were blinded. The primary outcome was pain measured on a numerical rating scale (NRS) after 24 h. Secondary outcomes were need for rescue analgesia, and pain after 1, 2, 3, 6 and 12 h. The mean, rest and maximum NRS scores were measured for 14 days.
RESULTS


A total of 138 patients were included, of whom 46 and 44 received general anaesthesia with or without ropivacaine respectively, and 23 and 25 received spinal anaesthesia with or without ropivacaine respectively (P = 0·858). The mean NRS score differed significantly at 24 h (mean(s.d.) 1·1(0·1) versus 2·3(0·2); P < 0·001), but not at 1 h (1·4(0·2) versus 2·2(0·3); P = 0·051). The NRS score was lower with use of ropivacaine at 2 h (1·0(0·2) versus 1·6(0·2); P = 0·045), 3 h (0·9(0·2) versus 1·5(0·2); P = 0·022), 6 h (1·1(0·2) versus 1·8(0·2); P = 0·042) and 12 h (1·2(0·2) versus 1·8(0·2); P = 0·034). The use of oral morphine equivalents was 10·2(1·4) and 16·6(2·5) mg with and without ropivacaine respectively (P = 0·028). The mean and maximum NRS scores within 14 days were lower when ropivacaine was used (95 per cent c.i. for difference 0·14 to 0·49 (P = 0·002) and 0·39 to 0·63 (P < 0·001) respectively). There was no injection-associated morbidity.
CONCLUSION


Perianal block as an adjunct to general or regional anaesthesia should be recommended for proctological surgery. It yields a reduction in pain, a reduced need for opioids, and a faster recovery with minimal risk of adverse events. Registration number: NCT03405922 ( http://www.clinicaltrials.gov).",2020,"It yields a reduction in pain, a reduced need for opioids, and a faster recovery with minimal risk of adverse events.","['Between January 2018 and April 2019', 'A total of 138 patients were included, of whom 46 and 44 received', 'proctological surgery', 'patients with and without a perianal block']","['spinal anaesthesia with or without ropivacaine', 'placebo', '2·3(0·2', 'general anaesthesia with or without ropivacaine', 'ropivacaine or placebo', 'oral morphine equivalents was 10·2(1·4) and 16·6(2·5)\u2009mg with and without ropivacaine', 'ropivacaine']","['rescue analgesia, and pain', 'mean, rest and maximum NRS scores', 'NRS score', 'injection-associated morbidity', 'pain', 'pain measured on a numerical rating scale (NRS', 'mean NRS score', 'mean and maximum NRS scores']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0442158', 'cui_str': 'Perianal region structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}]","[{'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0222045'}]",138.0,0.573644,"It yields a reduction in pain, a reduced need for opioids, and a faster recovery with minimal risk of adverse events.","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Rotigliano', 'Affiliation': 'Clarunis, Pelvic Floor Unit, University Centre for Gastrointestinal and Liver Diseases, St Clara Hospital and University Hospital Basle, Basle, Switzerland.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Füglistaler', 'Affiliation': 'Clarunis, Pelvic Floor Unit, University Centre for Gastrointestinal and Liver Diseases, St Clara Hospital and University Hospital Basle, Basle, Switzerland.'}, {'ForeName': 'M-O', 'Initials': 'MO', 'LastName': 'Guenin', 'Affiliation': 'Clarunis, Pelvic Floor Unit, University Centre for Gastrointestinal and Liver Diseases, St Clara Hospital and University Hospital Basle, Basle, Switzerland.'}, {'ForeName': 'G-B', 'Initials': 'GB', 'LastName': 'Dursunoglu', 'Affiliation': 'Clarunis, Pelvic Floor Unit, University Centre for Gastrointestinal and Liver Diseases, St Clara Hospital and University Hospital Basle, Basle, Switzerland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Freiermuth', 'Affiliation': 'Department of Anaesthesiology, St Clara Hospital, Basle, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'von Flüe', 'Affiliation': 'Clarunis, Pelvic Floor Unit, University Centre for Gastrointestinal and Liver Diseases, St Clara Hospital and University Hospital Basle, Basle, Switzerland.'}, {'ForeName': 'D C', 'Initials': 'DC', 'LastName': 'Steinemann', 'Affiliation': 'Clarunis, Pelvic Floor Unit, University Centre for Gastrointestinal and Liver Diseases, St Clara Hospital and University Hospital Basle, Basle, Switzerland.'}]",The British journal of surgery,['10.1002/bjs.11520']
824,32077404,Effects of a kindergarten intervention on vegetables served and staff's food-related practices: results of a cluster randomised controlled trial - the BRA study.,"OBJECTIVE


The aim of the current study was to evaluate the effect on frequency, variety and amount of vegetables served and staff's food-related practices in the multicomponent BRA intervention.
DESIGN


Cluster randomised controlled trial, conducted between Spring 2015 and Spring 2016. For allocation of the kindergartens, a stratified block randomisation was used. Data were collected in three ways: (i) a questionnaire for pedagogical leaders assessing the variety and frequency of vegetables served, including staff's food-related practices assumed to be related to vegetable intake; (ii) a questionnaire for kindergarten assistants assessing staff's food-related practices; (iii) a 5-d weighted vegetable diary assessing amount of vegetables served in a department.
SETTING


The target group for this study was public and private kindergartens in the counties of Vestfold and Buskerud, Norway.
PARTICIPANTS


A total of seventy-three kindergartens participated.
RESULTS


At follow-up I, the amount of vegetables served increased by approximately 20 g per person per day (P = 0·002), and the variety in served vegetables increased by one-and-a-half kind per month (P = 0·014) in the intervention group compared to the control group. No effects on the frequency of vegetables served or on staff's food-related practices were found.
CONCLUSIONS


The BRA intervention was successful in increasing the amount and variety of vegetables served within intervention kindergartens. Further research is needed to understand the mechanisms that can affect the staff's food-related practices.",2020,"No effects on the frequency of vegetables served or on staff's food-related practices were found.
","[""vegetables served and staff's food-related practices"", 'A total of seventy-three kindergartens participated', 'The target group for this study was public and private kindergartens in the counties of Vestfold and Buskerud, Norway']","[""questionnaire for kindergarten assistants assessing staff's food-related practices; (iii) a 5-d weighted vegetable diary assessing amount of vegetables served in a department"", 'kindergarten intervention', 'BRA intervention']","[""frequency of vegetables served or on staff's food-related practices""]","[{'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0453881', 'cui_str': 'Brassiere (physical object)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",73.0,0.0474356,"No effects on the frequency of vegetables served or on staff's food-related practices were found.
","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Himberg-Sundet', 'Affiliation': 'Department of Nutrition, Institute of basic medical Sciences, Faculty of Medicine, University of Oslo, Norway.'}, {'ForeName': 'Anne Lene', 'Initials': 'AL', 'LastName': 'Kristiansen', 'Affiliation': 'Department of Nutrition, Institute of basic medical Sciences, Faculty of Medicine, University of Oslo, Norway.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Frost Andersen', 'Affiliation': 'Department of Nutrition, Institute of basic medical Sciences, Faculty of Medicine, University of Oslo, Norway.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Bjelland', 'Affiliation': 'Department of Nutrition, Institute of basic medical Sciences, Faculty of Medicine, University of Oslo, Norway.'}, {'ForeName': 'Nanna', 'Initials': 'N', 'LastName': 'Lien', 'Affiliation': 'Department of Nutrition, Institute of basic medical Sciences, Faculty of Medicine, University of Oslo, Norway.'}]",Public health nutrition,['10.1017/S1368980019003963']
825,32182098,The Effects of a Video Intervention on Posthospitalization Pulmonary Rehabilitation Uptake. A Randomized Controlled Trial.,"Rationale:  Pulmonary rehabilitation (PR) after hospitalizations for exacerbations of chronic obstructive pulmonary disease (COPD) improves exercise capacity and health-related quality of life and reduces readmissions. However, posthospitalization PR uptake is low. To date, no trials of interventions to increase uptake have been conducted. Objectives:  To study the effect of a codesigned education video as an adjunct to usual care on posthospitalization PR uptake. Methods:  The present study was an assessor- and statistician-blinded randomized controlled trial with nested, qualitative interviews of participants in the intervention group. Participants hospitalized with COPD exacerbations were assigned 1:1 to receive either usual care (COPD discharge bundle including PR information leaflet) or usual care plus the codesigned education video delivered via a handheld tablet device at discharge. Randomization used minimization to balance age, sex, FEV 1  % predicted, frailty, transport availability, and previous PR experience. Measurements and Main Results:  The primary outcome was PR uptake within 28 days of hospital discharge. A total of 200 patients were recruited, and 196 were randomized (51% female, median FEV 1%  predicted, 36 [interquartile range, 27-48]). PR uptake was 41% and 34% in the usual care and intervention groups, respectively ( P  = 0.37), with no differences in secondary (PR referral and completion) or safety (readmissions and death) endpoints. A total of 6 of the 15 participants interviewed could not recall receiving the video. Conclusions:  A codesigned education video delivered at hospital discharge did not improve posthospitalization PR uptake, referral, or completion.",2020,"A co-designed education video delivered at hospital discharge did not improve post-hospitalization pulmonary rehabilitation uptake, referral or completion.","['participants in the intervention group', 'Six of the fifteen participants interviewed could not recall receiving the video', 'Pulmonary rehabilitation following hospitalizations for exacerbations of chronic obstructive pulmonary disease (COPD', '200 patients were recruited with 196 randomized (51% female, median (interquartile range', 'Post-Hospitalization Pulmonary Rehabilitation Uptake', 'Participants hospitalized with COPD exacerbations']","['usual care (COPD discharge bundle including pulmonary rehabilitation information leaflet) or usual care plus the co-designed education video delivered via a handheld tablet device at discharge', 'co-designed education video', 'Video Intervention']","['Pulmonary rehabilitation uptake', 'pulmonary rehabilitation uptake within 28 days of hospital discharge', 'secondary (pulmonary rehabilitation referral and completion) or safety (readmissions and death) endpoints']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation (regime/therapy)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}]","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation (regime/therapy)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}]","[{'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation (regime/therapy)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",200.0,0.195828,"A co-designed education video delivered at hospital discharge did not improve post-hospitalization pulmonary rehabilitation uptake, referral or completion.","[{'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Barker', 'Affiliation': 'Harefield Respiratory Research Group and.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Jones', 'Affiliation': 'Harefield Respiratory Research Group and.'}, {'ForeName': 'Winston', 'Initials': 'W', 'LastName': 'Banya', 'Affiliation': 'Medical Statistics, Research & Development, Royal Brompton and Harefield National Health Service (NHS) Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Fleming', 'Affiliation': 'Harefield Respiratory Research Group and.'}, {'ForeName': 'Samantha S C', 'Initials': 'SSC', 'LastName': 'Kon', 'Affiliation': 'Harefield Respiratory Research Group and.'}, {'ForeName': 'Stuart F', 'Initials': 'SF', 'LastName': 'Clarke', 'Affiliation': 'Hillingdon Integrated Respiratory Service, the Hillingdon Hospitals NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Claire M', 'Initials': 'CM', 'LastName': 'Nolan', 'Affiliation': 'Harefield Respiratory Research Group and.'}, {'ForeName': 'Suhani', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Harefield Respiratory Research Group and.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Walsh', 'Affiliation': 'Harefield Respiratory Research Group and.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Maddocks', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy, and Rehabilitation, King's College London, London, United Kingdom; and.""}, {'ForeName': 'Morag', 'Initials': 'M', 'LastName': 'Farquhar', 'Affiliation': 'School of Health Sciences, University of East Anglia, Norwich, United Kingdom.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Bell', 'Affiliation': 'National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care Northwest London, Imperial College, London, United Kingdom.'}, {'ForeName': 'Jadwiga A', 'Initials': 'JA', 'LastName': 'Wedzicha', 'Affiliation': 'National Heart and Lung Institute and.'}, {'ForeName': 'William D-C', 'Initials': 'WD', 'LastName': 'Man', 'Affiliation': 'Harefield Respiratory Research Group and.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201909-1878OC']
826,31980512,Blood pressure monitoring in high-risk pregnancy to improve the detection and monitoring of hypertension (the BUMP 1 and 2 trials): protocol for two linked randomised controlled trials.,"INTRODUCTION


Self-monitoring of blood pressure (BP) in pregnancy could improve the detection and management of pregnancy hypertension, while also empowering and engaging women in their own care. Two linked trials aim to evaluate whether BP self-monitoring in pregnancy improves the detection of raised BP during higher risk pregnancies (BUMP 1) and whether self-monitoring reduces systolic BP during hypertensive pregnancy (BUMP 2).
METHODS AND ANALYSES


Both are multicentre, non-masked, parallel group, randomised controlled trials. Participants will be randomised to self-monitoring with telemonitoring or usual care. BUMP 1 will recruit a minimum of 2262 pregnant women at higher risk of pregnancy hypertension and BUMP 2 will recruit a minimum of 512 pregnant women with either gestational or chronic hypertension. The BUMP 1 primary outcome is the time to the first recording of raised BP by a healthcare professional. The BUMP 2 primary outcome is mean systolic BP between baseline and delivery recorded by healthcare professionals. Other outcomes will include maternal and perinatal outcomes, quality of life and adverse events. An economic evaluation of BP self-monitoring in addition to usual care compared with usual care alone will be assessed across both study populations within trial and with modelling to estimate long-term cost-effectiveness. A linked process evaluation will combine quantitative and qualitative data to examine how BP self-monitoring in pregnancy is implemented and accepted in both daily life and routine clinical practice.
ETHICS AND DISSEMINATION


The trials have been approved by a Research Ethics Committee (17/WM/0241) and relevant research authorities. They will be published in peer-reviewed journals and presented at national and international conferences. If shown to be effective, BP self-monitoring would be applicable to a large population of pregnant women.
TRIAL REGISTRATION NUMBER


NCT03334149.",2020,"Two linked trials aim to evaluate whether BP self-monitoring in pregnancy improves the detection of raised BP during higher risk pregnancies (BUMP 1) and whether self-monitoring reduces systolic BP during hypertensive pregnancy (BUMP 2).
","['2262 pregnant women', '512 pregnant women with either gestational or chronic hypertension']","['BP self-monitoring', 'Self-monitoring of blood pressure (BP', 'telemonitoring or usual care', 'BUMP', 'Blood pressure monitoring']","['time to the first recording of raised BP by a healthcare professional', 'systolic BP', 'mean systolic BP', 'maternal and perinatal outcomes, quality of life and adverse events']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]","[{'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0026426', 'cui_str': 'Blood pressure monitoring'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0497247', 'cui_str': 'Finding of increased blood pressure (finding)'}, {'cui': 'C1704312', 'cui_str': 'Healthcare professional (occupation)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0034380'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",2262.0,0.18161,"Two linked trials aim to evaluate whether BP self-monitoring in pregnancy improves the detection of raised BP during higher risk pregnancies (BUMP 1) and whether self-monitoring reduces systolic BP during hypertensive pregnancy (BUMP 2).
","[{'ForeName': 'Greig', 'Initials': 'G', 'LastName': 'Dougall', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Marloes', 'Initials': 'M', 'LastName': 'Franssen', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Katherine Louise', 'Initials': 'KL', 'LastName': 'Tucker', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ly-Mee', 'Initials': 'LM', 'LastName': 'Yu', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Hinton', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Rivero-Arias', 'Affiliation': 'National Perinatal Epidemiology Unit (NPEU), Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Abel', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Allen', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rebecca Jane', 'Initials': 'RJ', 'LastName': 'Band', 'Affiliation': 'Academic Unit of Psychology, University of Southampton, Southampton, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Chisholm', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Crawford', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Green', 'Affiliation': 'Action on Pre-eclampsia, Evesham, UK.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Greenfield', 'Affiliation': 'Primary Care Clinical Sciences, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hodgkinson', 'Affiliation': 'Primary Care Clinical Sciences, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Leeson', 'Affiliation': 'Cardiovascular Clinical Research Facility, Division of Cardiovascular Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'McCourt', 'Affiliation': 'Centre for Maternal & Child Health Research, School of Health Sciences, City University, London, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'MacKillop', 'Affiliation': ""Nuffield Department of Women's & Reproductive Health, Oxford University Hospitals NHS Trust, Oxford, UK.""}, {'ForeName': 'Alecia', 'Initials': 'A', 'LastName': 'Nickless', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Sandall', 'Affiliation': ""Department of Women and Children's Health, Kings College, London, London, UK.""}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Santos', 'Affiliation': 'Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford, Oxford, UK.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Tarassenko', 'Affiliation': 'Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford, Oxford, UK.'}, {'ForeName': 'Carmelo', 'Initials': 'C', 'LastName': 'Velardo', 'Affiliation': 'Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford, Oxford, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Wilson', 'Affiliation': ""Department of Women and Children's Health, Kings College, London, London, UK.""}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Yardley', 'Affiliation': 'Academic Unit of Psychology, University of Southampton, Southampton, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Chappell', 'Affiliation': ""Department of Women and Children's Health, Kings College, London, London, UK lucy.chappell@kcl.ac.uk.""}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'McManus', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}]",BMJ open,['10.1136/bmjopen-2019-034593']
827,32176761,Testing the Food Experience in Healthy Human Volunteers: a Proof-of-Concept Study.,"BACKGROUND AND AIMS


For a healthy food to be introduced to the consumer's diet, it has to be attractive, yet testing for food acceptance and the sensory postprandial responses is still not standardized. The main objective of this study was to demonstrate that healthier foods can be obtained without impact on the responses to ingestion.
METHODS


A randomized, cross-over, double-blind, pilot study in non-obese, healthy men (n=8) comparing the responses to a standard sausage rich in animal fat (mortadella) versus a modified product based on a plant-derived fat analogue and an aroma. Palatability and postprandial sensations were measured on 10 cm scales and brain activity was evaluated by functional magnetic resonance imaging before and after each meal on separate days.
RESULTS


Both meals were rated equally palatable and induced the same degree of homeostatic sensations (satiety, fullness) with a similar hedonic dimension (improved mood and digestive well-being). Both meals induced similar changes in brain connectivity: decreased activity in the frontal-parietal, basal ganglia and thalamus, visual occipital, sensory-motor, temporal superior and in the ""default-mode"" networks, while increased activity was detected in the network associated with white matter.
CONCLUSION


A substantial improvement in the nutritional profile of food can be achieved without affecting the responses to ingestion.",2020,"Both meals induced similar changes in brain connectivity: decreased activity in the frontal-parietal, basal ganglia and thalamus, visual occipital, sensory-motor, temporal superior and in the ""default-mode"" networks, while increased activity was detected in the network associated with white matter.
","['Healthy Human Volunteers', 'non-obese, healthy men (n=8']",['standard sausage rich in animal fat (mortadella) versus a modified product based on a plant-derived fat analogue and an aroma'],"['Palatability and postprandial sensations', 'activity', 'homeostatic sensations (satiety, fullness', 'frontal-parietal, basal ganglia and thalamus, visual occipital, sensory-motor, temporal superior']","[{'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0452945', 'cui_str': 'Sausage (substance)'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0301429', 'cui_str': 'Animal fat (substance)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0360301', 'cui_str': 'Product base (product)'}, {'cui': 'C0032098', 'cui_str': 'Plants'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C2987717', 'cui_str': 'Aroma'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0442030', 'cui_str': 'Parietal (qualifier value)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0039729', 'cui_str': 'Thalamencephalon'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}]",,0.0519515,"Both meals induced similar changes in brain connectivity: decreased activity in the frontal-parietal, basal ganglia and thalamus, visual occipital, sensory-motor, temporal superior and in the ""default-mode"" networks, while increased activity was detected in the network associated with white matter.
","[{'ForeName': 'Teodora', 'Initials': 'T', 'LastName': 'Pribic', 'Affiliation': ""Digestive System Research Unit, University Hospital Vall d'Hebron; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (Ciberehd); Departament de Medicina, Universitat Autònoma de Barcelona, Spain. . teodora.pribic@gmail.com.""}, {'ForeName': 'Quiro', 'Initials': 'Q', 'LastName': 'Lopez', 'Affiliation': 'Grupo Carinsa, 08192 Sant Quirze del Vallès, Barcelona, Spain. quiro@carinsa.com.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Lucas', 'Affiliation': 'Grupo Carinsa, 08192 Sant Quirze del Vallès, Barcelona, Spain. elucas@carinsa.com.'}, {'ForeName': 'Dan M', 'Initials': 'DM', 'LastName': 'Livovsky', 'Affiliation': 'Digestive Diseases Institute Shaare Zedek Medical Center Lecturer Hebrew University Faculty of Medicine, Jerusalem, Israel.. danlivo@szmc.org.il.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Rovira', 'Affiliation': 'Digestive Diseases Institute; Shaare Zedek Medical Center, Hebrew University of Jerusalem, Israel. alex.rovira@idi.gencat.cat.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Accarino', 'Affiliation': ""Digestive System Research Unit, University Hospital Vall d'Hebron; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (Ciberehd); Departament de Medicina, Universitat Autònoma de Barcelona, Spain. aaccarino@telefonica.net.""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Azpiroz', 'Affiliation': ""Digestive System Research Unit, University Hospital Vall d'Hebron; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (Ciberehd); Departament de Medicina, Universitat Autònoma de Barcelona, Spain. azpiroz.fernando@gmail.com.""}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Pareto', 'Affiliation': ""Neuroradiology Section, Radiology Department, University Hospital Vall d'Hebron, Barcelona, Spain. deborah.pareto@idi.gencat.cat.""}]",Journal of gastrointestinal and liver diseases : JGLD,['10.15403/jgld-806']
828,30687908,Efficacy and safety of non-ablative vaginal erbium:YAG laser treatment as a novel surgical treatment for overactive bladder syndrome: comparison with anticholinergics and β3-adrenoceptor agonists.,"PURPOSE


To examine the efficacy and safety of non-ablative vaginal erbium:YAG laser (VEL) for the treatment of overactive bladder syndrome (OAB) compared with those of two other common pharmacotherapies, namely, anticholinergics and β3-adrenoceptor agonists.
METHODS


Female subjects aged 60-69 years who presented with symptoms of OAB from 2015 to 2017 were assigned to three groups (n = 50) receiving treatment with an anticholinergic agent (4 mg fesoterodine), a β3-adrenoceptor agonist (25 mg mirabegron), or VEL (20 min/session of VEL performed thrice). The OAB symptom score (OABSS), Vaginal Health Index Scale (VHIS), and occurrence of adverse effects were examined prior to and at 1 year following treatment initiation.
RESULTS


The three groups showed significant improvement (p < 0.001) for all items of the OABSS questionnaire. Improved VHIS scores were observed only in the VEL group. Furthermore, after VEL treatment, a negative correlation was observed between questions 3 (urinary urgency) and 4 (urgency urinary incontinence) of the OABSS and VHIS. Regarding safety, no adverse events were observed in the VEL group. However, subjects in the other two groups complained of constipation, as indicated by the Constipation Assessment Scale scores, and mouth dryness. The therapeutic effects were inadequate for one and two subjects in the VEL and β3-adrenoceptor agonist groups, respectively.
CONCLUSIONS


VEL safely and effectively improved OABSS through a different mechanism than that involved in pharmacotherapy. We propose the use of VEL as a novel surgical treatment option in the field of urology.",2019,The three groups showed significant improvement (p < 0.001) for all items of the OABSS questionnaire.,"['overactive bladder syndrome (OAB', 'overactive bladder syndrome', 'Female subjects aged 60-69\xa0years who presented with symptoms of OAB from 2015 to 2017 were assigned to three groups (n\u2009=\u200950) receiving treatment with an']","['VEL', 'non-ablative vaginal erbium:YAG laser treatment', 'anticholinergic agent (4\xa0mg fesoterodine', 'non-ablative vaginal erbium:YAG laser (VEL', 'β3-adrenoceptor agonist (25\xa0mg mirabegron), or VEL', 'anticholinergics and β3-adrenoceptor agonists']","['Improved VHIS scores', 'Constipation Assessment Scale scores, and mouth dryness', 'OABSS', 'adverse events', 'questions 3 (urinary urgency) and 4 (urgency urinary incontinence) of the OABSS and VHIS', 'Efficacy and safety', 'complained of constipation', 'OAB symptom score (OABSS), Vaginal Health Index Scale (VHIS), and occurrence of adverse effects', 'efficacy and safety']","[{'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0014688', 'cui_str': 'Erbium'}, {'cui': 'C0587723', 'cui_str': 'Lasers, Yttrium Aluminum Garnet'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242896', 'cui_str': 'Anticholinergic Agents'}, {'cui': 'C2343853', 'cui_str': 'fesoterodine'}, {'cui': 'C0034783', 'cui_str': 'Adrenoceptors'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C2983812', 'cui_str': 'mirabegron'}]","[{'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0085606', 'cui_str': 'Urgent desire to urinate (finding)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0222045'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.0172745,The three groups showed significant improvement (p < 0.001) for all items of the OABSS questionnaire.,"[{'ForeName': 'Nobuo', 'Initials': 'N', 'LastName': 'Okui', 'Affiliation': ""Uro-Gyn.Net Health Care Cooperation, Dr. Okuis' Urogynecology and Urology Clinic, Ootaki 2-6, Yokosuka, Kanagawa, 238-0008, Japan. okuinobuo@gmail.com.""}]",World journal of urology,['10.1007/s00345-019-02644-7']
829,32173247,Phase II Trial of Carfilzomib Plus Irinotecan in Patients With Small-cell Lung Cancer Who Have Progressed on Prior Platinum-based Chemotherapy.,"INTRODUCTION


The purpose of this study was to evaluate the efficacy and tolerability of carfilzomib plus irinotecan (C/I) in patients with relapsed small-cell lung cancer (SCLC).
PATIENTS AND METHODS


Patients with SCLC who progressed after 1 platinum-containing regimen for recurrent or metastatic disease were eligible. Patients were stratified as: sensitive (SS) (progressive disease > 90 days after chemotherapy) or refractory (RS) (progressive disease 30 to 90 days after chemotherapy) and received up to 6 cycles of C/I; imaging was performed every 2 cycles. The primary endpoint was 6-month overall survival (OS).
RESULTS


All 62 patients enrolled were evaluable for efficacy and adverse events. 6-month OS was 59% in the platinum SS and 54% in the platinum RS. The overall response rate was 21.6% (2.7% complete response, 18.9% partial response) in SS (n = 37) and 12.5% (all partial response) in RS (n = 25). The disease control rate was 68% (SS) and 56% (RS). Progression-free survival and OS were 3.6 months (95% confidence interval [CI], 2.6-4.6 months) and 6.9 months (95% CI, 4.3-12.3 months) in SS, and 3.3 months (95% CI, 1.8-3.9 months) and 6.8 months (95% CI, 4.1-11 months) in RS. Twenty-nine (47%) patients experienced ≥ grade 3 adverse events; 8 (12.9%) subjects had grade 4 toxicities. Three treatment-related deaths occurred: myocardial infarction (possible), lung infection (possible), and sepsis (probable).
CONCLUSION


In patients with relapsed SCLC, C/I was effective in the treatment of SS and RS. With 4.8% grade 5 toxicity, C/I is a viable option for relapsed patients with SCLC with performance status 0 to 1, particularly in platinum-resistant patients, or subjects who cannot receive immunotherapy.",2020,"Progression-free survival and OS were 3.6 months (95% confidence interval [CI], 2.6-4.6 months) and 6.9 months (95% CI, 4.3-12.3 months) in SS, and 3.3 months (95% CI, 1.8-3.9 months) and 6.8 months (95% CI, 4.1-11 months) in RS.","['patients with relapsed small-cell lung cancer (SCLC', 'Patients With Small-cell Lung Cancer', 'Patients with SCLC who progressed after 1 platinum-containing regimen for recurrent or metastatic disease were eligible', 'Patients were stratified as: sensitive (SS) (progressive disease > 90 days after chemotherapy) or refractory (RS) (progressive disease 30 to 90\xa0days after chemotherapy']","['Carfilzomib Plus Irinotecan', 'carfilzomib plus irinotecan (C/I']","['Progression-free survival and OS', 'efficacy and tolerability', 'disease control rate', 'deaths occurred: myocardial infarction (possible), lung infection (possible), and sepsis (probable', 'efficacy and adverse events', '6-month overall survival (OS', 'OS', 'overall response rate', 'grade 4 toxicities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149925', 'cui_str': 'Oat Cell Lung Cancer'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439083', 'cui_str': '>90 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}]","[{'cui': 'C2001856', 'cui_str': 'carfilzomib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0876973', 'cui_str': 'Pulmonary infection'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",62.0,0.0260902,"Progression-free survival and OS were 3.6 months (95% confidence interval [CI], 2.6-4.6 months) and 6.9 months (95% CI, 4.3-12.3 months) in SS, and 3.3 months (95% CI, 1.8-3.9 months) and 6.8 months (95% CI, 4.1-11 months) in RS.","[{'ForeName': 'Susanne M', 'Initials': 'SM', 'LastName': 'Arnold', 'Affiliation': 'University of Kentucky Markey Cancer Center, Lexington, KY; Division of Medical Oncology, Department of Medicine, University of Kentucky, Lexington, KY. Electronic address: susanne.arnold@uky.edu.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Chansky', 'Affiliation': 'Cancer Research and Biostatistics, Seattle, WA.'}, {'ForeName': 'Maria Q', 'Initials': 'MQ', 'LastName': 'Baggstrom', 'Affiliation': 'Department of Internal Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Thompson', 'Affiliation': 'Aurora Research Institute, Advocate Aurora Health, Milwaukee, WI.'}, {'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Sanborn', 'Affiliation': 'Division of Medical Oncology, Providence Cancer Center, Portland, OR.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Villano', 'Affiliation': 'University of Kentucky Markey Cancer Center, Lexington, KY; Division of Medical Oncology, Department of Medicine, University of Kentucky, Lexington, KY.'}, {'ForeName': 'Saiama N', 'Initials': 'SN', 'LastName': 'Waqar', 'Affiliation': 'Department of Internal Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hamm', 'Affiliation': 'Norton Cancer Institute, Louisville, KY.'}, {'ForeName': 'Markos', 'Initials': 'M', 'LastName': 'Leggas', 'Affiliation': 'University of Kentucky Markey Cancer Center, Lexington, KY; Department of Pharmaceutical Sciences, University of Kentucky, Lexington, KY.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Willis', 'Affiliation': 'Department of Internal Medicine, University of Texas Medical Branch, Galveston, TX.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Rosales', 'Affiliation': 'Department of Internal Medicine, Virginia Mason, Seattle, WA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Crowley', 'Affiliation': 'Cancer Research and Biostatistics, Seattle, WA.'}]",Clinical lung cancer,['10.1016/j.cllc.2020.01.006']
830,32006642,Effects of message framing and health literacy on intention to perform diabetes self-care: A randomized controlled trial.,"AIMS


To evaluate the effect of positive and negative message framing in diabetes education on attitudes, perceived control, and behavioral intentions toward diabetes self-care, and to identify potential moderating effects of health literacy on message framing.
METHODS


A total of 52 patients with type 2 diabetes that visited an ambulatory endocrinology wing at a university hospital in Korea were randomized into positive or negative message framing groups. Each group watched a 10-minute video that was either positively or negatively framed, accentuating desirable outcomes from good diabetes self-care in the former and undesirable outcomes from inadequate diabetes self-care in the latter. Two-way ANCOVA controlling for HbA1C was conducted to evaluate outcomes.
RESULTS


Patients who watched the negatively framed message showed significantly more favorable attitudes and perceived control toward diabetes self-care than those who viewed the positively framed message. Message framing had significant indirect effects on behavioral intentions for diabetes self-care that were mediated by attitudes and perceived control. Conversely, no significant interaction effects were observed between health literacy level and message framing of these same markers.
CONCLUSION


The use of negative message framing in diabetes education is a promising strategy for shaping favorable attitudes, beliefs, and intentions toward diabetes self-care behavior.",2020,"RESULTS


Patients who watched the negatively framed message showed significantly more favorable attitudes and perceived control toward diabetes self-care than those who viewed the positively framed message.","['52 patients with type 2 diabetes that visited an ambulatory endocrinology wing at a university hospital in Korea', 'Intention to Perform Diabetes Self-Care']",['Message Framing and Health Literacy'],"['behavioral intentions', 'favorable attitudes and perceived control toward diabetes self-care', 'health literacy level and message framing of these same markers']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0014137', 'cui_str': 'Endocrinology'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}]","[{'cui': 'C2362527', 'cui_str': 'Health Literacy'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",52.0,0.0526319,"RESULTS


Patients who watched the negatively framed message showed significantly more favorable attitudes and perceived control toward diabetes self-care than those who viewed the positively framed message.","[{'ForeName': 'Jihyun', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'College of Nursing, Research Institute of Nursing Science, Kyungpook National University, Daegu, South Korea.'}, {'ForeName': 'Su Hyun', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'College of Nursing, Research Institute of Nursing Science, Kyungpook National University, Daegu, South Korea. Electronic address: suhyun_kim@knu.ac.kr.'}, {'ForeName': 'Jung Guk', 'Initials': 'JG', 'LastName': 'Kim', 'Affiliation': 'Department of Endocrinology, Kyungpook National University Medical Center, Daegu, South Korea.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108043']
831,32171731,Methods for Dissecting Intersegmental Planes in Segmentectomy: A Randomized Controlled Trial.,"BACKGROUND


The perioperative outcomes of the use of stapling devices versus electrocautery to dissect intersegmental planes in patients undergoing segmentectomy for small pulmonary lesions is still unclear. The aim of this randomized controlled trial was to compare the perioperative outcomes of these two methods.
METHODS


A single-center, prospective, participant-blinded, randomized controlled trial (NCT03192904) was conducted with a preplanned sample size of 136. The primary outcome was the incidence of postoperative complications. Secondary outcomes included duration of operation, blood loss during operation, first-day drainage volume, duration of drainage, postoperative hospital stay, loss of lung function, and medical costs.
RESULTS


The trial was stopped early as a result of a marked difference in the primary outcome between groups at a scheduled interim check of the data after recruiting 70 patients. The incidence of postoperative complications (eg, air leakage) was higher in the electrocautery group than in the stapler device group (11/32, 34.4% vs 2/33, 6.1%, P = .004). There were no differences in duration of operation, blood loss during operation, first-day drainage volume, duration of drainage, postoperative hospital stays, loss of lung function, or total medical cost, although the per-patient cost of medical materials was higher in the stapler device group (US$4214.6 ± 1185.4 vs $3260.1 ± 852.6, P < .001).
CONCLUSIONS


Among patients undergoing segmentectomy, the use of stapler devices to divide intersegmental planes decreased postoperative complications without further compromising lung function or increasing economic burden.",2020,"The incidence of postoperative complications (e.g., air leakage etc.) was higher in the electrocautery group than in the stapler device group (11/32, 34.4% vs. 2/33, 6.1%, p = 0.004).","['Segmentectomy', 'patients undergoing segmentectomy', 'patients undergoing segmentectomy for small pulmonary lesions']",['stapling devices versus electrocautery'],"['postoperative complications', 'surgery duration, blood loss during surgery, first day drainage volume, duration of drainage, postoperative hospital stays, loss of lung function, or total medical cost, although the per-patient cost of medical materials', 'incidence of postoperative complications', 'duration of surgery, blood loss during surgery, first day drainage volume, duration of drainage, postoperative hospital stay, loss of lung function and medical costs', 'incidence of postoperative complications (e.g., air leakage etc']","[{'cui': 'C0024885', 'cui_str': 'Local Excision Mastectomy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]","[{'cui': 'C1293124', 'cui_str': 'Stapling procedure'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0013804', 'cui_str': 'Surgical Diathermy'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0333257', 'cui_str': 'Air leakage (morphologic abnormality)'}]",70.0,0.196245,"The incidence of postoperative complications (e.g., air leakage etc.) was higher in the electrocautery group than in the stapler device group (11/32, 34.4% vs. 2/33, 6.1%, p = 0.004).","[{'ForeName': 'Xingshi', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Runsen', 'Initials': 'R', 'LastName': 'Jin', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xiang', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Dingpei', 'Initials': 'D', 'LastName': 'Han', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Yajie', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Chengqiang', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Hailei', 'Initials': 'H', 'LastName': 'Du', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Junbiao', 'Initials': 'J', 'LastName': 'Hang', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.'}, {'ForeName': 'Alan D L', 'Initials': 'ADL', 'LastName': 'Sihoe', 'Affiliation': 'Department of Surgery, The University of Hong Kong, Hong Kong; The University of Hong Kong Shenzhen Hospital, Shenzhen; Department of Thoracic Surgery, Tongji University, Shanghai Pulmonary Hospital, Shanghai, China.'}, {'ForeName': 'Hecheng', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai. Electronic address: lihecheng2000@hotmail.com.'}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2020.02.013']
832,32171749,One Step at a Time: Step by Step Versus Continuous Video-Based Learning to Prepare Medical Students for Performing Surgical Procedures.,"OBJECTIVE


The objective of this study was to compare the effects of cognitive load and surgical performance in medical students that performed the open inguinal hernia repair after preparation with step-by-step video-demonstration versus continuous video-demonstration. Hypothetically, the step-by-step group will perceive lower extraneous load during the preparation of the surgical procedure compared to the continuous group. Subsequently, fewer errors will be made in the surgical performance assessment by the step-by-step group, resulting in better surgical performance.
DESIGN


In this prospective study, participants were randomly assigned to the step-by-step or continuous video-demonstration. They completed questionnaires regarding perceived cognitive load during preparation (10-point Likert scale). Their surgical performance was assessed on a simulation hernia model using the Observational Clinical Human Reliability Assessment.
SETTING


Erasmus University Medical Center, Rotterdam, the Netherlands.
PARTICIPANTS


Participants included medical students who were enrolled in extracurricular anatomy courses.
RESULTS


Forty-three students participated; 23 students in the step-by-step group and 20 in the continuous group. As expected, the step-by-step group perceived a lower extraneous cognitive load (2.92 ± 1.21) compared to the continuous group (3.91 ± 1.67, p = 0.030). The surgical performance was not statistically significantly different between both groups; however, in subanalyses on a selection of students that prepared for 1 to 2 hours, the step-by-step group made less procedural errors, 1.67 ± 1.11, compared to the continuous group, 3.06 ± 1.91, p = 0.018.
CONCLUSIONS


Our results suggest that preparation using step-by-step video-based learning results in lower extraneous cognitive load and subsequently fewer procedural errors during the surgical performance. For learning purposes, demonstration videos of surgical procedures should be presented in a segmented format.",2020,Our results suggest that preparation using step-by-step video-based learning results in lower extraneous cognitive load and subsequently fewer procedural errors during the surgical performance.,"['medical students', 'Erasmus University Medical Center, Rotterdam, the Netherlands', 'Forty-three students participated; 23 students in the step-by-step group and 20 in the continuous group', 'Participants included medical students who were enrolled in extracurricular anatomy courses']",['open inguinal hernia repair after preparation with step-by-step video-demonstration versus continuous video-demonstration'],"['surgical performance', 'extraneous cognitive load']","[{'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia (procedure)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]",43.0,0.0181373,Our results suggest that preparation using step-by-step video-based learning results in lower extraneous cognitive load and subsequently fewer procedural errors during the surgical performance.,"[{'ForeName': 'Tahmina', 'Initials': 'T', 'LastName': 'Nazari', 'Affiliation': 'Department of Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands; Incision Academy, Amsterdam, the Netherlands. Electronic address: t.nazari@erasmusmc.nl.'}, {'ForeName': 'Floyd W', 'Initials': 'FW', 'LastName': 'van de Graaf', 'Affiliation': 'Department of Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Mary E W', 'Initials': 'MEW', 'LastName': 'Dankbaar', 'Affiliation': 'The institute of Medical Education Research Rotterdam (iMERR), the Netherlands; Department of Education, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Johan F', 'Initials': 'JF', 'LastName': 'Lange', 'Affiliation': 'Department of Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands; Department of Surgery, IJsselland Hospital, Capelle aan den IJssel, The Netherlands.'}, {'ForeName': 'Jeroen J G', 'Initials': 'JJG', 'LastName': 'van Merriënboer', 'Affiliation': 'Department of Educational Development and Research, Faculty of Health, Medicine & Life Sciences, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Theo', 'Initials': 'T', 'LastName': 'Wiggers', 'Affiliation': 'Incision Academy, Amsterdam, the Netherlands.'}]",Journal of surgical education,['10.1016/j.jsurg.2020.02.020']
833,32171765,The Prognostic Value of Persistent Culture Positivity in Fungal Keratitis in the Mycotic Antimicrobial Localized Injection Trial.,"PURPOSE


To evaluate the utility of repeat cultures at days 3 and 7 after starting antifungal medications for predicting outcomes in fungal keratitis.
DESIGN


Prespecified secondary analysis of the randomized clinical Mycotic Antimicrobial Localized Injection trial.
METHODS


Patients presenting to Aravind Eye Hospital, Pondicherry, India, with fungal keratitis and visual acuity worse than 20/70 received topical natamycin and were randomized to either receive intrastromal injection of voriconazole or topical therapy alone. All subjects received corneal cultures at date of presentation, day 3, and day 7. Outcome measures included 3-week and 3-month visual acuity and scar size, corneal perforation, and/or the need for therapeutic penetrating keratoplasty (TPK). Visual acuity and scar size were analyzed with multiple linear regression controlling for baseline measures. Survival analysis was used to analyze the risk of corneal perforation and/or need for TPK.
RESULTS


Of the 70 study subjects with fungal keratitis, 25 of 69 (36%) remained culture positive at day 3, and 20 of 62 (32%) were culture positive at day 7. Culture positivity at day 3 conferred a hazard ratio of 2.8 for requiring TPK (P = .03) but was not a statistically significant predictor of perforation, scar size, or final visual acuity. Culture positivity at day 7 had a hazard ratio of 3.5 for requiring TPK (P = .003). Those with positive cultures at day 7 had on average 3 logMAR lines worse visual acuity at 3 months (95% confidence interval 0.9 to 5.2 logMAR lines, P = .006) and 1.1 mm larger scar size at 3 months after controlling for baseline measures (95% confidence interval 0.1 to 2.2 mm; P = .03).
CONCLUSIONS


While not as predictive as day 7 cultures, culture positivity at day 3 after starting treatment is a significant predictor of the need for TPK in patients with moderate-to-severe filamentous fungal keratitis. This has applications for risk stratification, and may facilitate earlier consideration of TPK in high-risk patients.",2020,"Culture positivity at day 3 conferred a hazard ratio of 2.8 for requiring TPK (p=0.03), but was not a statistically significant predictor of perforation, scar size, or final visual acuity.","['Pondicherry with fungal keratitis and visual acuity worse than 20/70 received', 'Patients presenting to Aravind Eye Hospital', 'patients with moderate to severe filamentous fungal keratitis']","['topical natamycin', 'voriconazole or topical therapy alone']","['Visual acuity and scar size', 'fungal keratitis', 'scar size', '3-week and 3-month visual acuity and scar size, corneal perforation and/or the need for therapeutic penetrating keratoplasty (TPK', 'average 3-LogMAR lines worse visual acuity', 'Culture positivity', 'perforation, scar size, or final visual acuity']","[{'cui': 'C1262117', 'cui_str': 'Mycotic keratitis'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0027444', 'cui_str': 'Natamycin'}, {'cui': 'C0393080', 'cui_str': 'voriconazole'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1262117', 'cui_str': 'Mycotic keratitis'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0339293', 'cui_str': 'Corneal Perforation'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0010042', 'cui_str': 'Grafting, Corneal'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0549099', 'cui_str': 'Perforation (morphologic abnormality)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}]",,0.481944,"Culture positivity at day 3 conferred a hazard ratio of 2.8 for requiring TPK (p=0.03), but was not a statistically significant predictor of perforation, scar size, or final visual acuity.","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Pickel', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Shivananda', 'Initials': 'S', 'LastName': 'Narayana', 'Affiliation': 'Aravind Eye Hospital, Pondicherry, India.'}, {'ForeName': 'Tiruvengada', 'Initials': 'T', 'LastName': 'Krishnan', 'Affiliation': 'Aravind Eye Hospital, Pondicherry, India.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Ramakrishnan', 'Affiliation': 'Aravind Eye Hospital, Pondicherry, India.'}, {'ForeName': 'Puja Prativa', 'Initials': 'PP', 'LastName': 'Samantaray', 'Affiliation': 'Aravind Eye Hospital, Pondicherry, India.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California, USA; UCSF Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Redd', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California, USA; UCSF Department of Ophthalmology, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California, USA; UCSF Department of Ophthalmology, University of California San Francisco, San Francisco, California, USA; UCSF Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rose-Nussbaumer', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California, USA; UCSF Department of Ophthalmology, University of California San Francisco, San Francisco, California, USA; The Permanente Medical Group, Redwood City, California, USA. Electronic address: jennifer.rose-nussbaumer@ucsf.edu.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.02.021']
834,32131790,A randomized controlled trial of an educational intervention to promote oral and dental health of patients with type 2 diabetes mellitus.,"BACKGROUND


Diabetes is the most prevalent disease resulted from metabolic disorders. This study aimed to investigate the effect of training based on health belief model (HBM) on oral hygiene-related behaviors in patients with type 2 diabetes mellitus.
METHODS


This study was conducted as an educational randomized controlled trial (single blind) on 120 patients with type 2 diabetes referring to a diabetes clinic selected through systematic sampling, who were assigned to two groups of control (N = 60) and intervention (N = 60). The data collection tool was a valid and reliable questionnaire based on HBM which was completed by both groups before the intervention. Then, the intervention group received 4 sessions of educational program based on HBM in 1 month, and the same questionnaire was completed again after 3 months and the data were analyzed through SPSS version 20 software with inferential statistics, t-test, paired t-tests, Chi square, Mann-Whitney test, and Wilcoxon test analysis.
RESULTS


Three months after the intervention, awareness of the patients and perceived susceptibility, benefits, self-efficacy, internal cue to action, and performance in oral and dental hygiene-related behaviors had a significant increase in the intervention group (p < 0.05). So that the performance of oral and dental hygiene in the intervention group increased from 2.16 ± 0.71 to 3.25 ± 0.49 (p = 0.001) after the education.
CONCLUSION


Our results suggest that training patients with diabetes based on HBM as well as through active follow-up can enhance their skills in oral and dental hygiene-related behaviors. Controlling, monitoring and follow-up during the program are also recommended.
TRIAL REGISTRATION


Iranian Registry of Clinical Trials, IRCT 2017050733847N1. Prospectively registered 14 June 2017, http://en.irct.ir/trial/26011.",2020,The data collection tool was a valid and reliable questionnaire based on HBM which was completed by both groups before the intervention.,"['120 patients with type 2 diabetes referring to a diabetes clinic selected through systematic sampling', 'patients with type 2 diabetes mellitus', 'Prospectively registered 14 June 2017, http://en.irct.ir/trial/26011']","['educational intervention', '4 sessions of educational program based on HBM', 'IRCT', 'training based on health belief model (HBM']","['awareness of the patients and perceived susceptibility, benefits, self-efficacy, internal cue to action, and performance in oral and dental hygiene-related behaviors', 'performance of oral and dental hygiene']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3839636', 'cui_str': 'Diabetes clinic'}, {'cui': 'C0220922', 'cui_str': 'systematics'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C3714363', 'cui_str': 'Health belief model (qualifier value)'}]","[{'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",120.0,0.0502902,The data collection tool was a valid and reliable questionnaire based on HBM which was completed by both groups before the intervention.,"[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Malekmahmoodi', 'Affiliation': 'Department of Health Education and promotion, Faculty of Health, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Shamsi', 'Affiliation': 'Department of Health Education and promotion, Faculty of Health, Arak University of Medical Sciences, Arak, Iran. mohsen_shamsi1360@yahoo.com.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Roozbahani', 'Affiliation': 'Department of Health Education and promotion, Faculty of Health, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Rahmatollah', 'Initials': 'R', 'LastName': 'Moradzadeh', 'Affiliation': 'Department of Epidemiology, Faculty of Health, Arak University of Medical Sciences, Arak, Iran.'}]",BMC public health,['10.1186/s12889-020-8395-4']
835,32131795,Effects of humorous interventions on the willingness to donate organs: a quasi-experimental study in the context of medical cabaret.,"BACKGROUND


It has been shown that fears and misconceptions negatively affect the willingness to donate organs. Empirical studies have examined health communication strategies that serve to debunk these fears. There are promising indications that humor has the potential to influence health-related attitudes and behaviors. This study examines empirically whether medical cabaret, as a specific format for delivering health-related information in a humorous way, affects the willingness to donate organs.
METHODS


A quasi-experimental study was conducted among the audience of a medical cabaret live show. Participants in two intervention groups and one control group were interviewed just before the start of the live show (t 0 ) and about 6 weeks later (t 1 ). Intervention group 1 (I 1 ) witnessed a ten-minute sequence by the cabaret artist about organ donation. Participants in I 2  witnessed the sequence and, in addition, received an organ donor card. Descriptive statistics and t-tests were used to investigate changes in attitudes and the willingness to donate organs from t 0  to t 1 .
RESULTS


A significant increase in the willingness to donate organs and an improvement in general attitude was observed in the intervention groups. Moreover, significantly more participants in I 2  carried an organ donor card after the intervention. Some fears could be reduced, while understanding of the reasons for organ donation could be increased via the intervention.
CONCLUSIONS


The study confirms that medical cabaret is able to affect respondents' attitudes and behaviors even in the context of organ donation. Medical cabaret can enhance the willingness to donate organs and dispel negative concerns.",2020,The study confirms that medical cabaret is able to affect respondents' attitudes and behaviors even in the context of organ donation.,['A quasi-experimental study was conducted among the audience of a medical cabaret live show'],['humorous interventions'],"['willingness to donate organs', 'general attitude']","[{'cui': 'C2985410', 'cui_str': 'Clinical Trials, Nonrandomized'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]",[],"[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.0132667,The study confirms that medical cabaret is able to affect respondents' attitudes and behaviors even in the context of organ donation.,"[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Heitland', 'Affiliation': 'Bielefeld University, School of Public Health, P.O. Box 100 131, 33501, Bielefeld, Germany.'}, {'ForeName': 'Eckart', 'Initials': 'E', 'LastName': 'von Hirschhausen', 'Affiliation': 'Foundation ""Humor Hilft Heilen"", Bennauer Str. 31, 53115, Bonn, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Fischer', 'Affiliation': 'Bielefeld University, School of Public Health, P.O. Box 100 131, 33501, Bielefeld, Germany. f.fischer@uni-bielefeld.de.'}]",BMC public health,['10.1186/s12889-020-8400-y']
836,32184050,Tracking the Nonenrolled: Lung Cancer Screening Patterns Among Individuals not Accrued to a Clinical Trial.,"INTRODUCTION


For lung cancer screening, the available data are often derived from patients enrolled prospectively in clinical trials. We, therefore, investigated lung cancer screening patterns among individuals eligible for, but not enrolled in, a screening trial.
PATIENTS AND METHODS


From February 2017 through February 2019, we enrolled subjects in a trial examining telephone-based navigation during low-dose computed tomography (LDCT) for lung cancer screening. We identified patients for whom LDCT was ordered and who were approached, but not enrolled, in the trial. We categorized nonenrollment as the patient had declined or could not be reached. We compared the characteristics and LDCT completion rates among these groups and the enrolled population using the 2-sample t test and χ 2  test.
RESULTS


Of 900 individuals approached for participation (mean age, 62 years; 45% women, 53% black), 447 were enrolled in the screening clinical trial. No significant demographic differences were found between the enrolled and nonenrolled cohorts. Of the 453 individuals not enrolled, 251 (55%) had declined participation and 202 (45%) could not be reached, despite up to 6 attempts. LDCT completion was significantly associated with enrollment status: 81% of enrolled individuals, 73% of individuals who declined participation, and 49% of those who could not be reached (P < .001).
CONCLUSIONS


In the present single-center study, demographic factors did not predict for participation in a lung cancer screening trial. Lung cancer screening adherence rates were substantially lower for those not enrolled in a screening trial, especially for those who could not be contacted. These findings may inform the broader implementation of screening programs.",2020,"LDCT completion was significantly associated with enrollment status: 81% of enrolled individuals, 73% of individuals who declined participation, and 49% of those who could not be reached (P ","['900 individuals approached for participation (mean age, 62 years; 45% women, 53% black), 447 were enrolled in the screening clinical trial', '453 individuals not enrolled, 251 (55%) had declined participation and 202 (45%) could not be reached, despite\xa0up to 6 attempts', 'lung cancer screening patterns among individuals eligible for, but not enrolled in, a screening trial', 'From February 2017 through February 2019', 'Individuals']",['telephone-based navigation during low-dose computed tomography (LDCT'],"['characteristics and LDCT completion rates', 'Lung cancer screening adherence rates', 'LDCT completion']","[{'cui': 'C4517900', 'cui_str': '900 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0281477', 'cui_str': 'Lung cancer screening (procedure)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0281477', 'cui_str': 'Lung cancer screening (procedure)'}]",447.0,0.104894,"LDCT completion was significantly associated with enrollment status: 81% of enrolled individuals, 73% of individuals who declined participation, and 49% of those who could not be reached (P ","[{'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Gerber', 'Affiliation': 'Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, TX; Division of Hematology-Oncology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX; Division of Hematology-Oncology, Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, TX. Electronic address: david.gerber@utsouthwestern.edu.'}, {'ForeName': 'Heidi A', 'Initials': 'HA', 'LastName': 'Hamann', 'Affiliation': 'Department of Psychology, University of Arizona, Tucson, AZ; Department of Family and Community Medicine, University of Arizona, Tucson, AZ.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Chavez', 'Affiliation': 'Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Dorsey', 'Affiliation': 'Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Noel O', 'Initials': 'NO', 'LastName': 'Santini', 'Affiliation': 'Parkland Health and Hospital System, Dallas, TX.'}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Browning', 'Affiliation': 'Parkland Health and Hospital System, Dallas, TX; Department of Radiology, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Cristhiaan D', 'Initials': 'CD', 'LastName': 'Ochoa', 'Affiliation': 'Parkland Health and Hospital System, Dallas, TX; Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Adesina', 'Affiliation': 'Parkland Health and Hospital System, Dallas, TX.'}, {'ForeName': 'Vijaya Subbu', 'Initials': 'VS', 'LastName': 'Natchimuthu', 'Affiliation': 'Parkland Health and Hospital System, Dallas, TX.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Steen', 'Affiliation': 'Parkland Health and Hospital System, Dallas, TX; Division of General Internal Medicine, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, TX; Division of Hematology-Oncology, Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Simon J Craddock', 'Initials': 'SJC', 'LastName': 'Lee', 'Affiliation': 'Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, TX; Division of Hematology-Oncology, Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, TX.'}]",Clinical lung cancer,['10.1016/j.cllc.2020.02.010']
837,31915178,"Recurrence of WHO-defined fast breathing pneumonia among infants, its occurrence and predictors in Pakistan: a nested case-control analysis.","OBJECTIVES


Studies in low-income and middle-income countries have shown an adverse association between environmental exposures including poverty. There is little literature from South Asia. We aimed to test the associations between housing, indoor air pollution and children's respiratory health and recurrent fast breathing pneumonia in a poor urban setting in Pakistan.
SETTING


Primary health centres in a periurban slum in Karachi, Pakistan.
METHODS


Nested matched case-control study within a non-inferiority randomised controlled trial of fast breathing pneumonia (Randomised Trial of Amoxicillin vs Placebo for Pneumonia (RETAPP)) in periurban slums of Karachi, Pakistan. Cases were children aged 2-60 months enrolled in RETAPP with fast breathing pneumonia who presented again with fast breathing between 8 weeks and 12 months after full recovery. Controls, selected in a 2:1 ratio, were age-matched participants who did not represent. Multivariable conditional logistic regression analysis was undertaken to explore associations with potentially modifiable environmental predictors including housing type, indoor air quality, exposure to tobacco smoke, outdoor pollution, household crowding, water and sanitation quality, nutritional status, immunisation completeness, breast feeding and airways hyperactivity.
RESULTS


Fast breathing recurred in 151 (3.7%) of children out of the total (4003) enrolled in the trial. Poor-quality housing of either katcha or mixed type strongly predicted recurrence with adjusted matched ORs 2.43 (95% CI 1.02 to 5.80) and 2.44 (1.11 to 5.38), respectively. Poor air quality, cooking fuel, inadequate ventilation, nutritional status, water, sanitation and hygiene (WASH) index, wheeze at first presentation and group of initial trial assignment were not independently predictive of recurrence.
CONCLUSION


Poor-quality housing independently predicted recurrence of fast breathing pneumonia.
TRIAL REGISTRATION NUMBER


NCT02372461.",2020,"RESULTS


Fast breathing recurred in 151 (3.7%) of children out of the total (4003) enrolled in the trial.","['for Pneumonia (RETAPP)) in periurban slums of Karachi, Pakistan', 'Primary health centres in a periurban slum in Karachi, Pakistan', 'Controls, selected in a 2:1 ratio, were age-matched participants who did not represent', 'Cases were children aged 2-60 months enrolled in RETAPP with fast breathing pneumonia who presented again with fast breathing between 8 weeks and 12 months after full recovery', 'Nested matched case-control study within a non-inferiority randomised controlled trial of fast breathing pneumonia', ""and children's respiratory health and recurrent fast breathing pneumonia in a poor urban setting in Pakistan""]","['housing, indoor air pollution', 'Amoxicillin vs Placebo']","['housing type, indoor air quality, exposure to tobacco smoke, outdoor pollution, household crowding, water and sanitation quality, nutritional status, immunisation completeness, breast feeding and airways hyperactivity', 'Recurrence of WHO-defined fast breathing pneumonia', 'Poor air quality, cooking fuel, inadequate ventilation, nutritional status, water, sanitation and hygiene (WASH) index, wheeze', 'recurrence']","[{'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0037345', 'cui_str': 'Slums'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0007328', 'cui_str': 'Case-Referrent Studies'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}]","[{'cui': 'C0020056', 'cui_str': 'Housing'}, {'cui': 'C0085420', 'cui_str': 'Air Pollution, Indoor'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0020056', 'cui_str': 'Housing'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0085760', 'cui_str': 'Air Quality, Indoor'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0439994', 'cui_str': 'Tobacco smoke (substance)'}, {'cui': 'C0392355', 'cui_str': 'Pollution (event)'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C0439812', 'cui_str': 'Completeness (qualifier value)'}, {'cui': 'C0006147', 'cui_str': 'Breastfeeding'}, {'cui': 'C0424295', 'cui_str': 'Increased purposeful goal-directed activity'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C2371710', 'cui_str': 'Air Quality'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0556991', 'cui_str': 'Fuel (substance)'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}]",,0.146635,"RESULTS


Fast breathing recurred in 151 (3.7%) of children out of the total (4003) enrolled in the trial.","[{'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Brown', 'Affiliation': ""International Maternal and Child Health, Department of Women's and Children's Health, Uppsala University, Academiska Sjukhuset, Uppsala, 75185, Sweden nick.brown@kbh.uu.se.""}, {'ForeName': 'Arjumand', 'Initials': 'A', 'LastName': 'Rizvi', 'Affiliation': 'Department of Child Health, Aga Khan University Hospital, National Stadium Rd, Karachi, Sindh, 74800, Pakistan.'}, {'ForeName': 'Salima', 'Initials': 'S', 'LastName': 'Kerai', 'Affiliation': 'University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Muhammad Imran', 'Initials': 'MI', 'LastName': 'Nisar', 'Affiliation': 'Department of Child Health, Aga Khan University Hospital, National Stadium Rd, Karachi, Sindh, 74800, Pakistan.'}, {'ForeName': 'Najeeb', 'Initials': 'N', 'LastName': 'Rahman', 'Affiliation': 'Department of Child Health, Aga Khan University Hospital, National Stadium Rd, Karachi, Sindh, 74800, Pakistan.'}, {'ForeName': 'Benazir', 'Initials': 'B', 'LastName': 'Baloch', 'Affiliation': 'Department of Child Health, Aga Khan University Hospital, National Stadium Rd, Karachi, Sindh, 74800, Pakistan.'}, {'ForeName': 'Fyezah', 'Initials': 'F', 'LastName': 'Jehan', 'Affiliation': 'Department of Child Health, Aga Khan University Hospital, National Stadium Rd, Karachi, Sindh, 74800, Pakistan.'}]",BMJ open,['10.1136/bmjopen-2019-035277']
838,31174215,"Including 60 mg Elemental Iron in a Multiple Micronutrient Supplement Blunts the Increase in Serum Zinc after 12 Weeks of Daily Supplementation in Predominantly Anemic, Nonpregnant Cambodian Women of Reproductive Age.","BACKGROUND


Multiple micronutrient (MMN) supplementation may result in interaction effects due to competing absorptive pathways of trace elements.
OBJECTIVES


The aim of this study was to investigate the effect of MMN supplementation with or without iron on serum zinc, selenium, and copper concentrations in Cambodian women.
METHODS


In a 2 × 2 factorial double-blind randomized 12-wk trial, predominantly anemic, nonpregnant women (aged 18-45 y) received daily 60 mg of iron (Fe; n = 201); 14 other micronutrients including zinc (15 mg), selenium (65 μg), and copper (2 mg), but no iron (MMN; n = 202); 60 mg iron plus MMN (Fe + MMN; n = 206); or a placebo (n = 200). Fasting morning blood was collected at baseline and 12 wk from women in 26 villages in Kampong Chhnang province. Serum zinc, selenium, and copper concentrations (secondary outcomes of the randomized controlled trial) were measured using inductively coupled plasma mass spectrometry. Generalized linear regression was used to estimate intervention effects [β coefficient (95% CI)] for Fe (with or without MMN) and MMN (with or without Fe) after testing for the presence of an Fe × MMN interaction.
RESULTS


A total of 760 women completed the trial. Zinc deficiency prevalence at baseline was 45% (inflammation-adjusted serum zinc <10.7 μmol/L). A significant Fe × MMN interaction (P = 0.02) was detected in the 2 × 2 analysis with serum zinc concentration as the outcome: the MMN group had a higher mean serum zinc concentration at 12 wk (12.3 μmol/L; 95% CI: 12.2, 12.4 μmol/L) compared with all other groups, and the Fe + MMN group had a higher mean serum zinc concentration (11.6 μmol/L; 95% CI: 11.5, 11.7 μmol/L) compared with the Fe group (11.0 μmol/L; 95% CI: 10.9, 11.0 μmol/L) and the placebo group (11.2 μmol/L; 95% CI: 11.1, 11.4 μmol/L).
CONCLUSIONS


The inclusion of 60 mg iron in the daily MMN formulation may be interfering with the absorption and/or metabolism of supplemental zinc in Cambodian women. This is of particular concern when MMN supplementation is implemented in populations with risk of zinc deficiency. This trial was registered at clinicaltrials.gov as NCT-02481375.",2019,Zinc deficiency prevalence at baseline was 45% (inflammation-adjusted serum zinc <10.7 μmol/L).,"['Cambodian women', 'populations with risk of zinc deficiency', '760 women completed the trial', 'predominantly anemic, nonpregnant women (aged 18-45 y']","['placebo', 'MMN supplementation', 'Fe (with or without MMN) and MMN', 'MMN', 'daily 60 mg of iron (Fe; n\xa0=\xa0201); 14 other micronutrients including zinc (15 mg), selenium (65 μg), and copper (2 mg), but no iron (MMN; n\xa0=\xa0202); 60 mg iron plus MMN (Fe\xa0+\xa0MMN']","['Fasting morning blood', 'serum zinc, selenium, and copper concentrations', 'mean serum zinc concentration', 'Serum Zinc', 'Serum zinc, selenium, and copper concentrations', 'Zinc deficiency prevalence']","[{'cui': 'C1553323', 'cui_str': 'Cambodians'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0235950', 'cui_str': 'Zinc deficiency (disorder)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0373587', 'cui_str': 'Copper measurement (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0856205', 'cui_str': 'Serum zinc'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0373587', 'cui_str': 'Copper measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0235950', 'cui_str': 'Zinc deficiency (disorder)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",760.0,0.747151,Zinc deficiency prevalence at baseline was 45% (inflammation-adjusted serum zinc <10.7 μmol/L).,"[{'ForeName': 'Jeffrey B', 'Initials': 'JB', 'LastName': 'Holmes', 'Affiliation': 'Food, Nutrition, and Health, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Hou', 'Initials': 'H', 'LastName': 'Kroeun', 'Affiliation': 'Helen Keller International, Phnom Penh, Cambodia.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Houghton', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Rosalind S', 'Initials': 'RS', 'LastName': 'Gibson', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Kimberly B', 'Initials': 'KB', 'LastName': 'Harding', 'Affiliation': 'Nutrition International, Ottawa, Canada.'}, {'ForeName': 'Luz Maria', 'Initials': 'LM', 'LastName': 'De-Regil', 'Affiliation': 'Nutrition International, Ottawa, Canada.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Kraemer', 'Affiliation': 'Sight and Life Foundation, Basel, Switzerland, and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Susan I', 'Initials': 'SI', 'LastName': 'Barr', 'Affiliation': 'Food, Nutrition, and Health, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Crystal D', 'Initials': 'CD', 'LastName': 'Karakochuk', 'Affiliation': 'Food, Nutrition, and Health, University of British Columbia, Vancouver, Canada.'}]",The Journal of nutrition,['10.1093/jn/nxz097']
839,31567817,ANTI-VASCULAR ENDOTHELIAL GROWTH FACTOR THERAPY AND RISK OF TRACTION RETINAL DETACHMENT IN EYES WITH PROLIFERATIVE DIABETIC RETINOPATHY: Pooled Analysis of Five DRCR Retina Network Randomized Clinical Trials.,"PURPOSE


To investigate whether anti-vascular endothelial growth factor (anti-VEGF) for diabetic macular edema or proliferative diabetic retinopathy (PDR) increases the risk of traction retinal detachment (TRD) among eyes with PDR.
METHODS


Pooled analysis of PDR eyes from Protocols I, J, N, S, or T with Early Treatment Diabetic Retinopathy Study level ≥61 (prompt vitrectomy was not planned) randomly assigned to the control group (laser photocoagulation, sham, or intravitreal saline; 396 eyes) or anti-VEGF (487 eyes). The primary outcome was investigator-identified TRD within 1 year of randomization.
RESULTS


The 1-year cumulative probability of TRD was 6.8% (95% confidence interval: 4.6%-9.9%, 25 events) in control-group eyes and 4.8% (95% confidence interval: 3.2%-7.3%, 22 events) in anti-VEGF group eyes (hazard ratio = 0.95 [95% confidence interval: 0.54-1.66, P = 0.86]). The cumulative probability of vitrectomy for TRD was 4.4% (16 events) in control-group eyes and 2.2% (9 events) in anti-VEGF group eyes (P = 0.19). Percentage with TRD and vitrectomy for TRD were similar within strata of diabetic retinopathy severity.
CONCLUSION


These findings do not support the hypothesis that anti-VEGF therapy for diabetic macular edema or PDR increases the risk of TRD among eyes with PDR similar to those enrolled in five DRCR Retina Network protocols for which prompt vitrectomy was not planned.",2020,The cumulative probability of vitrectomy for TRD was 4.4% (16 events) in control-group eyes and 2.2% (9 events) in anti-VEGF group eyes (P = 0.19).,"['DETACHMENT IN EYES WITH PROLIFERATIVE DIABETIC RETINOPATHY', 'diabetic macular edema or proliferative diabetic retinopathy (PDR']","['anti-VEGF therapy', 'TRD and vitrectomy', 'anti-vascular endothelial growth factor (anti-VEGF', 'ANTI-VASCULAR ENDOTHELIAL GROWTH', 'control group (laser photocoagulation, sham, or intravitreal saline; 396 eyes) or anti-VEGF']","['cumulative probability of vitrectomy for TRD', 'investigator-identified TRD within 1 year of randomization', '1-year cumulative probability of TRD']","[{'cui': 'C0541879', 'cui_str': 'Detachment'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0154830', 'cui_str': 'PDR - proliferative diabetic retinopathy'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0023694', 'cui_str': 'Photocoagulation'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]",487.0,0.063096,The cumulative probability of vitrectomy for TRD was 4.4% (16 events) in control-group eyes and 2.2% (9 events) in anti-VEGF group eyes (P = 0.19).,"[{'ForeName': 'Neil M', 'Initials': 'NM', 'LastName': 'Bressler', 'Affiliation': 'Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Wesley T', 'Initials': 'WT', 'LastName': 'Beaulieu', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Susan B', 'Initials': 'SB', 'LastName': 'Bressler', 'Affiliation': 'Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Glassman', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'B Michele', 'Initials': 'BM', 'LastName': 'Melia', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Jampol', 'Affiliation': 'Feinberg School of Medicine, Northwestern University Medical School, Chicago, Illinois.'}, {'ForeName': 'Chirag D', 'Initials': 'CD', 'LastName': 'Jhaveri', 'Affiliation': 'Retina Research Center, Austin, Texas.'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Salehi-Had', 'Affiliation': 'Atlantis Eye Care, Huntington Beach, California.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Velez', 'Affiliation': 'Valley Eye Physicians and Surgeons, Ayer, Massachusetts.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Sun', 'Affiliation': 'Harvard Department of Ophthalmology, Joslin Diabetes Center, Beetham Eye Institute, Boston, Massachusetts.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002633']
840,31306302,Resistance Exercise-induced Changes in Muscle Phenotype Are Load Dependent.,"INTRODUCTION


Lower-load (LL), higher-repetition resistance exercise training (RET) can increase muscle mass in a similar degree as higher-load (HL), lower-repetition RET. However, little is known about how LL and HL RET modulate other aspects of the RET phenotype such as satellite cells, myonuclei, and mitochondrial proteins. We aimed to investigate changes in muscle mass, muscle strength, satellite cell activity, myonuclear addition, and mitochondrial protein content after prolonged RET with LL and HL RET.
METHODS


We recruited 21 young men and randomly assigned them to perform 10 wk RET (leg press, leg extension, and leg curl) three times per week with the following conditions: 80FAIL (80% one-repetition maximum [1RM] performed to volitional fatigue), 30WM (30%1RM with volume matched to 80FAIL), and 30FAIL (30%1RM to volitional fatigue). Skeletal muscle biopsies were taken from the vastus lateralis pre- and post-RET intervention.
RESULTS


After 10 wk of RET, only 30FAIL and 80FAIL showed an increase in peak torque and type I fiber cross-sectional area (P < 0.05). Moreover, only 30FAIL resulted in a significant decrease in the myonuclear domain of type II muscle fibers and an increase in mitochondrial proteins related to autophagy, fission, and fusion (all P < 0.05).
CONCLUSION


We discovered that LL RET was effective at increasing the content of several mitochondrial proteins. Similar to previous research, we found that changes in muscle mass and strength were independent of load when repetitions were performed to volitional fatigue.",2019,"After 10 weeks of RET, only 30FAIL and 80FAIL showed an increase in peak torque and type I fiber cross-sectional area (CSA) (p<0.05).",['21 young men'],"['Lower-load (LL), higher-repetition resistance exercise training (RET', 'LL RET', '80FAIL (80% one repetition maximum performed [1RM] to volitional fatigue), 30WM (30%1RM with volume matched to 80FAIL), and 30FAIL (30%1RM to volitional fatigue']","['myonuclear domain of type II muscle fibers', 'peak torque and type I fiber cross-sectional area (CSA', 'muscle mass, muscle strength, satellite cell activity, myonuclear addition, and mitochondrial protein content']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0543431', 'cui_str': 'ret (qualifier value)'}, {'cui': 'C0042950', 'cui_str': 'Will'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0242873', 'cui_str': 'Muscle Fibers, Type II'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0332221', 'cui_str': 'Satellite (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0949610', 'cui_str': 'Mitochondrial Proteins'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]",21.0,0.0226715,"After 10 weeks of RET, only 30FAIL and 80FAIL showed an increase in peak torque and type I fiber cross-sectional area (CSA) (p<0.05).","[{'ForeName': 'Changhyun', 'Initials': 'C', 'LastName': 'Lim', 'Affiliation': 'Department of Kinesiology, McMaster University, Ontario, CANADA.'}, {'ForeName': 'Hyo Jeong', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Aging Physiology, Korea National Sport University, Seoul, SOUTH KOREA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Morton', 'Affiliation': 'Department of Kinesiology, McMaster University, Ontario, CANADA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Harris', 'Affiliation': 'Junipa Ltd., Newmarket, Suffolk, UNITED KINGDOM.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Phillips', 'Affiliation': 'Department of Kinesiology, McMaster University, Ontario, CANADA.'}, {'ForeName': 'Tae Seok', 'Initials': 'TS', 'LastName': 'Jeong', 'Affiliation': 'SPIK Sport Medicine Clinic and Performance Centre, Seoul, SOUTH KOREA.'}, {'ForeName': 'Chang Keun', 'Initials': 'CK', 'LastName': 'Kim', 'Affiliation': 'Human Physiology, Korea National Sport University, Seoul, SOUTH KOREA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002088']
841,32171875,Photodynamic therapy for endodontic treatment of primary teeth: A randomized controlled clinical trial.,"OBJECTIVES


This study aimed to evaluate the reduction in bacterial load following conventional endodontic treatment with and without antimicrobial photodynamic therapy (a-PDT) in primary teeth.
METHODS


Thirty primary anterior teeth with a diagnosis of pulp necrosis were selected. Patients were randomly allocated to two groups as follows: Group I, patients undergoing conventional root canal therapy (n = 15) and Group II, patients undergoing conventional root canal therapy combined with antimicrobial PDT (n = 15). For PDT, methylene blue, at a concentration of 0.005 %, was used as the photosensitizing agent, which was applied to the interior of the canal with a sterile paper cone for 3 min, followed by the administration of laser light for 40 s (wavelength: 660 nm, energy density: 4 J/cm², power: 100 mW), delivered in direct contact at the entrance to the root canal. Two microbiological samples of the intra-canal content were taken (one before and one immediately after treatment in both groups) using paper cones. Clinical follow-up involved the investigation of fistulas and mobility and was performed 1- and 3 months after treatment. Data were statistically analyzed.
RESULTS


The reduction in bacterial load was 93 % in Group I and 99 % in Group II, with no statistically significant difference.
CONCLUSIONS


Conventional treatment combined with antimicrobial PDT with parameters used in this study proved effective but presented equal efficacious capability to conventional endodontic treatment alone.
CLINICAL SIGNIFICANCE


The use of PDT has been studied in endodontic treatment protocols in permanent teeth. However, clinical trials in deciduous teeth are necessary for establishing the effectiveness and parameters of this application. The present study analyzes the results of PDT in the endodontic treatment of deciduous teeth.",2020,"The reduction in bacterial load was 93% in Group I and 99% in Group II, with no statistically significant difference.
","['Thirty primary anterior teeth with a diagnosis of pulp necrosis were selected', 'primary teeth']","['conventional endodontic treatment with and without antimicrobial photodynamic therapy (PDT', 'conventional root canal therapy', 'conventional root canal therapy combined with antimicrobial PDT']",['reduction in bacterial load'],"[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0011407', 'cui_str': 'Pulp Necrosis'}, {'cui': 'C3266841', 'cui_str': 'Baby Teeth'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0700632', 'cui_str': 'Endodontic procedure (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0031740', 'cui_str': 'Photodynamic Therapy'}, {'cui': 'C0044588', 'cui_str': 'PDT'}, {'cui': 'C0035849', 'cui_str': 'Root Canal Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C2936404', 'cui_str': 'Bacterial Load'}]",30.0,0.0362408,"The reduction in bacterial load was 93% in Group I and 99% in Group II, with no statistically significant difference.
","[{'ForeName': 'Camila Basilio', 'Initials': 'CB', 'LastName': 'Okamoto', 'Affiliation': 'Program of Biophotonics Applied to the Health Sciences, Nove de Julho University, São Paulo, Brazil.'}, {'ForeName': 'Sandra Kalil', 'Initials': 'SK', 'LastName': 'Bussadori', 'Affiliation': 'Program of Biophotonics Applied to the Health Sciences, Nove de Julho University, São Paulo, Brazil.'}, {'ForeName': 'Renato Araujo', 'Initials': 'RA', 'LastName': 'Prates', 'Affiliation': 'Program of Biophotonics Applied to the Health Sciences, Nove de Julho University, São Paulo, Brazil.'}, {'ForeName': 'Ana Carolina Costa', 'Initials': 'ACC', 'LastName': 'da Mota', 'Affiliation': 'Program of Biophotonics Applied to the Health Sciences, Nove de Julho University, São Paulo, Brazil.'}, {'ForeName': 'Anna Carolina Ratto', 'Initials': 'ACR', 'LastName': 'Tempestini Horliana', 'Affiliation': 'Program of Biophotonics Applied to the Health Sciences, Nove de Julho University, São Paulo, Brazil.'}, {'ForeName': 'Kristianne Porta Santos', 'Initials': 'KPS', 'LastName': 'Fernandes', 'Affiliation': 'Program of Biophotonics Applied to the Health Sciences, Nove de Julho University, São Paulo, Brazil.'}, {'ForeName': 'Lara Jansiski', 'Initials': 'LJ', 'LastName': 'Motta', 'Affiliation': 'Program of Biophotonics Applied to the Health Sciences, Nove de Julho University, São Paulo, Brazil; Biophotonics Applied to the Health Sciences, Nove de Julho University, Rua Vergueiro, 235/249 - Liberdade, 01504-000, São Paulo, SP, Brazil. Electronic address: larajmotta@terra.com.br.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101732']
842,32171877,Bond strength of root canal filling with radicular dentin previously treated with either photobiomodulation or photodynamic therapy: Effect of disinfection protocols.,"PURPOSE


The aim of the present study was to establish an assessment regarding the efficacy of final disinfection protocols and sealers on the bond strength (BS) of root canal (RC) filling materials on root dentin which has already been treated with photobiomodulation (PBT) or photodynamic therapy (PBT) respectively.
METHODS


One-hundred and twenty root canals were included in the present study. The selected teeth were cleaned and shaped to accept the obturation. The prepared specimens were subjected to laser therapy (PBT and PDT) and were randomized into three groups (n = 20/group) on the basis of irrigation technique: Group 1: distilled water (DW) + ultrasonic irrigation (UI); Group 2: 17 % EDTA; Group 3: 0.2 % Chlorhexidine digluconate (CHx) respectively. Each specific group was further divided into two subgroups (n = 10), based on endodontic sealing agent incorporated during obturation: AH Plus or MTA Fillapex. The push-out test was used to gauge the BS, whereas the evaluation was done with the help of two-way ANOVA which was followed by a subsequent Tukey post-hoc test. The chi-square test was used to calculate the mode of failure in the selected specimens (α = 5%).
RESULTS


The final irrigation protocols of 17 % EDTA and CHX helped to enhance the BS of RC filling material with either sealer agent used (p < 0.05), whereas, AH Plus reported an increase in the values of BS as compared to its counterpart, MTA Fillapex (p < 0.05). Increased values of cohesive failure were associated with all the groups, irrespective of the tested final irrigation protocols and RC sealer agents (p < 0.05). There was no significant difference between the laser therapies among all the groups (p < 0.05).
CONCLUSIONS


The use of 17 % EDTA and CHX and sealing material AH Plus increased the BS of the obturation on radicular dentin previously subjected to either of the mentioned laser therapies. Furthermore, no significant effect on the BS was observed with the use of lasers in the study.",2020,"Increased values of cohesive failure were associated with all the groups, irrespective of the tested final irrigation protocols and RC sealer agents (p < 0.05).",['One-hundred and twenty root canals were included in the present study'],"['photobiomodulation or photodynamic therapy', 'irrigation technique: Group 1: distilled water (DW) + ultrasonic irrigation (UI); Group 2: 17% EDTA; Group 3: 0.2% Chlorhexidine digluconate (CHx', 'AH', 'photobiomodulation (PBT) or photodynamic therapy (PBT', 'laser therapy (PBT and PDT', 'CHX', 'endodontic sealing agent incorporated during obturation: AH Plus or MTA Fillapex', 'CHX and sealing material AH']","['BS of RC filling material', 'Increased values of cohesive failure', 'values of BS', 'BS']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0086881', 'cui_str': 'Root Canal'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0031740', 'cui_str': 'Photodynamic Therapy'}, {'cui': 'C2959650', 'cui_str': 'Irrigation technique (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C1456803', 'cui_str': 'Ultrasonics'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0529584', 'cui_str': 'isothiocyanatobenzyl-EDTA'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0055361', 'cui_str': 'chlorhexidine gluconate'}, {'cui': 'C1955835', 'cui_str': 'Laser Therapy'}, {'cui': 'C0044588', 'cui_str': 'PDT'}, {'cui': 'C0700632', 'cui_str': 'Endodontic procedure (procedure)'}, {'cui': 'C0036492', 'cui_str': 'Seal (organism)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction (morphologic abnormality)'}, {'cui': 'C0673096', 'cui_str': 'AH Plus'}, {'cui': 'C3852787', 'cui_str': 'MTA-Fillapex'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}]","[{'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",,0.0161702,"Increased values of cohesive failure were associated with all the groups, irrespective of the tested final irrigation protocols and RC sealer agents (p < 0.05).","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Hashem', 'Affiliation': 'Dental Health Department, College of Applied Medical Sciences, King Saud University, P.O Box 10219, Riyadh, 11433, Saudi Arabia. Electronic address: mihashem@ksu.edu.sa.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'El-Hejazi', 'Affiliation': 'Operative and Esthetic Dentistry, College of Dentistry, King Saud University, Saudi Arabia.'}, {'ForeName': 'Muhammad Omar', 'Initials': 'MO', 'LastName': 'Niaz', 'Affiliation': 'Department of Community Dentistry, College of Dentistry, Foundation University, Islamabad, Pakistan.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Alsadon', 'Affiliation': 'Dental Health Department, College of Applied Medical Sciences, King Saud University, P.O Box 10219, Riyadh, 11433, Saudi Arabia.'}, {'ForeName': 'Bader M', 'Initials': 'BM', 'LastName': 'Alolayani', 'Affiliation': 'Dental Health Department, College of Applied Medical Sciences, King Saud University, P.O Box 10219, Riyadh, 11433, Saudi Arabia.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Fouad', 'Affiliation': 'Applied Medical Science Dept. CC, King Saud University, P.O Box 10219, Riyadh, 11433, Saudi Arabia; Biomedical Engineering Department, Faculty of Engineering, Helwan University, P.O. Box 11795, Helwan, 11792, Egypt.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101733']
843,32131082,Functional ability and quality of life in critical illness survivors with intensive care unit acquired weakness: A secondary analysis of a randomised controlled trial.,"INTRODUCTION


Intensive care unit acquired weakness (ICUAW) may contribute to functional disability in ICU survivors, yet performance-based data for general ICU patients are lacking. This study explored functional outcomes of (1) and risk factors for (2) weakness at ICU discharge.
METHODS


Data from a randomised controlled trial that investigated two early exercise regimes in previously independent, ventilated adults (n = 115) without any significant outcome-differences were used for the present analysis. ICUAW was clinically diagnosed in cooperative participants (n = 83) at ICU discharge with the Medical Research Council sum-score (MRC-SS) using a cut-off <48 for moderate or <36 for severe weakness. Primary outcomes were the 6-Minute Walk Test and Functional Independence Measure at hospital discharge. Secondary outcomes included health-related quality of life after six months. Risk factors during the ICU stay were explored for their effect on MRC-SS with linear regression.
RESULTS


Functional outcomes and length of hospital stay significantly differed in patients with severe, moderate to no weakness (6-Minute Walk test: p = 0.013; 110m [IQR 75-240], 196m [90-324.25], 222.5m [129-378.75], Functional Independence Measure: p = 0.001; 91[IQR 68-101], 113[102.5-118.5], 112[97-123], length of stay after ICU discharge: p = 0.008; 20.9d [IQR 15.83-30.73], 16.86d [13.07-27.10], 11.16d [7.35-19.74]). However, after six months participants had similar values for quality of life regardless of their strength at ICU discharge (Short-Form 36 sum-scores physical health: p = 0.874, mental health: p = 0.908). In-bed immobilisation was the most significant factor associated with weakness at ICU discharge in the regression models (MRC-SS: -24.57(95%CI [-37.03 to -12.11]); p<0.001).
CONCLUSIONS


In this general, critically ill cohort, weakness at ICU discharge was associated with short-term functional disability and prolonged hospital length of stay, but not with quality of life, which was equivalent to the values for patients without ICUAW within six months. Immobilisation may be a modifiable risk factor to prevent ICUAW. Prospective trials are needed to validate these results.
TRIAL REGISTRATION


German Clinical Trials Register (DRKS) identification number: DRKS00004347, registered on September 10, 2012.",2020,In-bed immobilisation was the most significant factor associated with weakness at ICU discharge in the regression models (MRC-SS: -24.57(95%CI,"['critical illness survivors with intensive care unit acquired weakness', 'previously independent, ventilated adults (n = 115']",[],"['length of hospital stay', '6-Minute Walk Test and Functional Independence Measure at hospital discharge', 'health-related quality of life', 'quality of life regardless of their strength at ICU discharge', 'Functional ability and quality of life']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C4087120', 'cui_str': 'Intensive care unit acquired weakness'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}]",[],"[{'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure (assessment scale)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",115.0,0.270823,In-bed immobilisation was the most significant factor associated with weakness at ICU discharge in the regression models (MRC-SS: -24.57(95%CI,"[{'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Eggmann', 'Affiliation': 'Department of Physiotherapy, Insel Group, Inselspital, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Gere', 'Initials': 'G', 'LastName': 'Luder', 'Affiliation': 'Department of Physiotherapy, Insel Group, Inselspital, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Martin L', 'Initials': 'ML', 'LastName': 'Verra', 'Affiliation': 'Department of Physiotherapy, Insel Group, Inselspital, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Irincheeva', 'Affiliation': 'CTU Bern, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Caroline H G', 'Initials': 'CHG', 'LastName': 'Bastiaenen', 'Affiliation': 'Department of Epidemiology, Research Line Functioning and Rehabilitation CAPHRI, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Stephan M', 'Initials': 'SM', 'LastName': 'Jakob', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}]",PloS one,['10.1371/journal.pone.0229725']
844,32186326,Long-term dietary intervention reveals resilience of the gut microbiota despite changes in diet and weight.,"BACKGROUND


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


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


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


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


These results suggest a resilience to perturbation of the microbiota's starting profile. When considering the established contribution of obesity-associated microbiotas to weight gain in animal models, microbiota resilience may need to be overcome for long-term alterations to human physiology. This trial was registered at clinicaltrials.gov as NCT01826591.",2020,"We used 16S ribosomal RNA gene amplicon sequencing to profile microbiota composition over a 12-mo period in 49 participants as part of a larger randomized dietary intervention study of participants consuming either a healthy low-carbohydrate or a healthy low-fat diet.
",['49 participants as part of a larger randomized dietary intervention study of participants consuming either a healthy low-carbohydrate or a healthy low-fat diet'],[],['weight loss'],"[{'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}]",[],"[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",49.0,0.0217248,"We used 16S ribosomal RNA gene amplicon sequencing to profile microbiota composition over a 12-mo period in 49 participants as part of a larger randomized dietary intervention study of participants consuming either a healthy low-carbohydrate or a healthy low-fat diet.
","[{'ForeName': 'Gabriela K', 'Initials': 'GK', 'LastName': 'Fragiadakis', 'Affiliation': 'Microbiology and Immunology, Stanford School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Hannah C', 'Initials': 'HC', 'LastName': 'Wastyk', 'Affiliation': 'Department of Bioengineering, Stanford School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Robinson', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Erica D', 'Initials': 'ED', 'LastName': 'Sonnenburg', 'Affiliation': 'Microbiology and Immunology, Stanford School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Justin L', 'Initials': 'JL', 'LastName': 'Sonnenburg', 'Affiliation': 'Microbiology and Immunology, Stanford School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Gardner', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford School of Medicine, Stanford, CA, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa046']
845,31709984,1-Year Outcomes of Angina Management Guided by Invasive Coronary Function Testing (CorMicA).,"OBJECTIVES


The aim of this study was to test the hypothesis that invasive coronary function testing at time of angiography could help stratify management of angina patients without obstructive coronary artery disease.
BACKGROUND


Medical therapy for angina guided by invasive coronary vascular function testing holds promise, but the longer-term effects on quality of life and clinical events are unknown among patients without obstructive disease.
METHODS


A total of 151 patients with angina with symptoms and/or signs of ischemia and no obstructive coronary artery disease were randomized to stratified medical therapy guided by an interventional diagnostic procedure versus standard care (control group with blinded interventional diagnostic procedure results). The interventional diagnostic procedure-facilitated diagnosis (microvascular angina, vasospastic angina, both, or neither) was linked to guideline-based management. Pre-specified endpoints included 1-year patient-reported outcome measures (Seattle Angina Questionnaire, quality of life [EQ-5D]) and major adverse cardiac events (all-cause mortality, myocardial infarction, unstable angina hospitalization or revascularization, heart failure hospitalization, and cerebrovascular event) at subsequent follow-up.
RESULTS


Between November 2016 and December 2017, 151 patients with ischemia and no obstructive coronary artery disease were randomized (n = 75 to the intervention group, n = 76 to the control group). At 1 year, overall angina (Seattle Angina Questionnaire summary score) improved in the intervention group by 27% (difference 13.6 units; 95% confidence interval: 7.3 to 19.9; p < 0.001). Quality of life (EQ-5D index) improved in the intervention group relative to the control group (mean difference 0.11 units [18%]; 95% confidence interval: 0.03 to 0.19; p = 0.010). After a median follow-up duration of 19 months (interquartile range: 16 to 22 months), major adverse cardiac events were similar between the groups, occurring in 9 subjects (12%) in the intervention group and 8 (11%) in the control group (p = 0.803).
CONCLUSIONS


Stratified medical therapy in patients with ischemia and no obstructive coronary artery disease leads to marked and sustained angina improvement and better quality of life at 1 year following invasive coronary angiography. (Coronary Microvascular Angina [CorMicA]; NCT03193294).",2020,Quality of life (EQ5D index) improved in the intervention group relative to the control group (mean difference 0.11 units [18%]; 0.03 to 0.19;p=0.010).,"['patients without obstructive disease', '151 angina patients with symptoms and/or signs of ischemia and no obstructive coronary artery disease (INOCA', 'Between 11/2016-12/2017 151 INOCA patients were randomized (n=75 intervention group; n=76 control group']","['Angina Management Guided by Invasive Coronary Function Testing (CorMicA', 'stratified medical therapy guided by an interventional diagnostic procedure (IDP) versus standard care (control group with blinded IDP results']","['1-year patient reported outcome measures (Seattle Angina Questionnaire [SAQ], quality of life [EQ5D]) and major adverse cardiovascular events (all- cause mortality, myocardial infarction, unstable angina hospitalization/revascularization, heart failure hospitalization, cerebrovascular event) at subsequent follow-up', 'Quality of life (EQ5D index', 'overall angina (SAQ summary score', 'sustained angina improvement and better quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0430022', 'cui_str': 'Diagnostic procedure (procedure)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0021532', 'cui_str': 'Riboxin'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0034380'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}]",151.0,0.0885377,Quality of life (EQ5D index) improved in the intervention group relative to the control group (mean difference 0.11 units [18%]; 0.03 to 0.19;p=0.010).,"[{'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Ford', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, United Kingdom; British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom; Gosford Hospital, NSW Health, Gosford, Australia.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Stanley', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Novalia', 'Initials': 'N', 'LastName': 'Sidik', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Good', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Rocchiccioli', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, United Kingdom; British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'McEntegart', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, United Kingdom; British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Watkins', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, United Kingdom.'}, {'ForeName': 'Hany', 'Initials': 'H', 'LastName': 'Eteiba', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, United Kingdom.'}, {'ForeName': 'Aadil', 'Initials': 'A', 'LastName': 'Shaukat', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, United Kingdom.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Lindsay', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, United Kingdom.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Robertson', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, United Kingdom.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Hood', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, United Kingdom.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'McGeoch', 'Affiliation': 'University Hospital Hairmyres, East Kilbride, United Kingdom.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'McDade', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, United Kingdom.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Yii', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'McCartney', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Corcoran', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Collison', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, United Kingdom; British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Rush', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'McConnachie', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Rhian M', 'Initials': 'RM', 'LastName': 'Touyz', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Keith G', 'Initials': 'KG', 'LastName': 'Oldroyd', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, United Kingdom; British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, United Kingdom; British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom. Electronic address: colin.berry@glasgow.ac.uk.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.11.001']
846,31011797,"Polyethylene glycol 3350 plus electrolytes for chronic constipation: a 2-week, randomized, double-blind, placebo-controlled study with a 52-week open-label extension.","BACKGROUND


Although polyethylene glycol 3350 plus electrolytes (PEG3350 + E) is the most widely used osmotic laxative in Europe, prospective data on its long-term (over 6 months) safety and efficacy are not available to date.
METHODS


Japanese patients with chronic constipation were randomized to receive PEG3350 + E or placebo for 2 weeks orally. Following this, the patients received PEG3350 + E in the 52-week extension study. The starting dose was 13.7 g/day dissolved in 125 mL of water, and dose titration was allowed (upper limit 41.1 g/day) according to the patient's bowel condition. The primary efficacy endpoint was the change from baseline in frequency of spontaneous bowel movements (SBMs) at week 2 in the double-blind study. Secondary endpoints and adverse events were assessed. Safety and efficacy were also assessed in the extension study.
RESULTS


Among 204 patients who provided informed consent, 156 were randomized and included in the full analysis. The frequency of SBMs was significantly higher with PEG3350 + E [least squares mean (LSM) 4.3, 95% confidence interval (CI) 3.6-4.9] compared with placebo (LSM 1.6, 95% CI 1.2-2.1; P < 0.0001). A total of 153 patients entered the extension study; PEG3350 + E led to a sustained improvement in bowel function. The common adverse drug reactions during the entire study period were mild gastrointestinal disorders (abdominal pain 4.5%, diarrhea 3.8%, nausea 3.2%, abdominal distension 2.6%).
CONCLUSIONS


Treatment with PEG3350 + E resolved constipation in the short term, was well tolerated, and led to sustained improvement in bowel function in the long-term treatment of Japanese patients with chronic constipation.
CLINICAL TRIAL REGISTRATION NUMBER


Japic CTI-163167.",2019,A total of 153 patients entered the extension study; PEG3350 + E led to a sustained improvement in bowel function.,"['204 patients who provided informed consent, 156 were randomized and included in the full analysis', '153 patients', 'chronic constipation', 'Japanese patients with chronic constipation']","['PEG3350\u2009+\u2009E', 'placebo', 'polyethylene glycol 3350 plus electrolytes (PEG3350\u2009+\u2009E', 'PEG3350\u2009', 'Polyethylene glycol 3350 plus electrolytes', 'PEG3350\u2009+\u2009E or placebo']","['bowel function', 'frequency of SBMs', 'frequency of spontaneous bowel movements (SBMs', 'adverse events', 'mild gastrointestinal disorders (abdominal pain 4.5%, diarrhea 3.8%, nausea', 'Safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0401149', 'cui_str': 'Chronic constipation (disorder)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0724672', 'cui_str': 'POLYETHYLENE GLYCOL 3350'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013832', 'cui_str': 'Electrolytes'}]","[{'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0017178', 'cui_str': 'Gastrointestinal Diseases'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",153.0,0.546027,A total of 153 patients entered the extension study; PEG3350 + E led to a sustained improvement in bowel function.,"[{'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nakajima', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University, 3-9 Fuku-ura, Kanazawa-ku, Yokohama, 236-0004, Japan. nakajima-tky@umin.ac.jp.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Shinbo', 'Affiliation': 'Clinical Development Department, EA Pharma Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Oota', 'Affiliation': 'Clinical Development Department, EA Pharma Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Gastroenterology and Hepatology, Shimane University School of Medicine, Izumo City, Shimane, Japan.'}]",Journal of gastroenterology,['10.1007/s00535-019-01581-x']
847,32180305,The gains of a 4-week cognitive training are not modulated by novelty.,"Cognitive training should not only improve performance of the trained task, but also untrained abilities. Exposure to novelty can improve subsequent memory performance, suggesting that novelty exposure might be a critical factor to promote the effects of cognitive training. Therefore, we combined a 4-week working memory training with novelty exposure. Neuropsychological tests and MRI data were acquired before and after training to analyze behavior and changes in gray matter volume, myelination, and iron levels. In total, 83 healthy older humans participated in one of three groups: Two groups completed a 4-week computerized cognitive training of a two-back working memory task, either in combination with novel or with familiarized nature movies. A third group did not receive any training. As expected, both training groups showed improvements in task specific working memory performance and reaction times. However, there were no transfer or novelty effects on fluid intelligence, verbal memory, digit-span, and executive functions. At the neural level, no significant micro- or macrostructural changes emerged in either group. Our findings suggest that working memory training in healthy older adults is associated with task-specific improvements, but these gains do not transfer to other cognitive domains, and it does not lead to structural brain changes.",2020,"However, there were no transfer or novelty effects on fluid intelligence, verbal memory, digit-span, and executive functions.","['83 healthy older humans participated in one of three groups: Two groups completed a', 'healthy older adults']","['Cognitive training', 'working memory training', '4-week computerized cognitive training of a two-back working memory task, either in combination with novel or with familiarized nature movies']","['subsequent memory performance', 'fluid intelligence, verbal memory, digit-span, and executive functions', 'task specific working memory performance and reaction times', 'gray matter volume, myelination, and iron levels', 'Neuropsychological tests and MRI data']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1262865', 'cui_str': 'Natures (qualifier value)'}, {'cui': 'C0681495', 'cui_str': 'Movies'}]","[{'cui': 'C1285654', 'cui_str': 'Ability to remember'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0018220', 'cui_str': 'Gray Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychologic Tests'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]",83.0,0.0118094,"However, there were no transfer or novelty effects on fluid intelligence, verbal memory, digit-span, and executive functions.","[{'ForeName': 'Davina', 'Initials': 'D', 'LastName': 'Biel', 'Affiliation': 'Institute of Psychology I, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Tineke K', 'Initials': 'TK', 'LastName': 'Steiger', 'Affiliation': 'Institute of Psychology I, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Volkmann', 'Affiliation': 'Institute for Multimedia and Interactive Systems, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Jochems', 'Affiliation': 'Institute for Multimedia and Interactive Systems, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Nico', 'Initials': 'N', 'LastName': 'Bunzeck', 'Affiliation': 'Institute of Psychology I, University of Lübeck, Lübeck, Germany.'}]",Human brain mapping,['10.1002/hbm.24965']
848,30915676,Community-Based Cervical Cancer Education: Changes in Knowledge and Beliefs Among Vietnamese American Women.,"Low cervical cancer screening rates among Vietnamese American women have been attributed, in part, to inadequate knowledge about cervical cancer and health beliefs that hinder screening. A community-based educational program was developed to improve knowledge and attitudes toward cervical cancer screening in this underserved population. It was hypothesized that the program would result in increases in knowledge, as well as enhanced health beliefs and self-efficacy toward obtaining cervical cancer screening. Using a group-randomized design, 1488 women from 30 Vietnamese community-based organizations were assigned to either the intervention (n = 816) or control (n = 672) conditions. The intervention group received cervical cancer education delivered by bilingual community health educators. Intervention content addressed individual beliefs and expectancies regarding cervical cancer screening (e.g., perceived risk of developing cervical cancer; perceived benefits and barriers to screening; social and cultural norms regarding screening). The control group received general health education, including information about cancer screening. Knowledge and health beliefs were assessed at baseline and post-intervention. Among women in the intervention group, overall knowledge about cervical cancer and screening guidelines increased from pre- to post-program (30% vs. 88%, p < 0.001), perceived benefits of screening increased (3.50 vs. 4.49, p < 0.001), and perceived barriers to screening decreased (3.13 vs. 2.25, p < 0.001). Changes in knowledge and health beliefs were not observed among women in the control group. A community-based educational program can help increase knowledge about cervical cancer and screening, promote positive changes in women's beliefs about the benefits of cervical cancer screening, and reduce perceived barriers to screening. Such programs may play an important role in addressing health disparities and informing underserved populations about recommended screening tests.",2019,"Among women in the intervention group, overall knowledge about cervical cancer and screening guidelines increased from pre- to post-program (30% vs. 88%, p < 0.001), perceived benefits of screening increased (3.50 vs. 4.49, p < 0.001), and perceived barriers to screening decreased (3.13 vs. 2.25, p < 0.001).","['Vietnamese American Women', '1488 women from 30 Vietnamese community-based organizations', 'Vietnamese American women']","['general health education, including information about cancer screening', 'cervical cancer education delivered by bilingual community health educators']","['overall knowledge about cervical cancer and screening guidelines', 'health beliefs and self-efficacy', 'knowledge and attitudes toward cervical cancer screening', 'perceived benefits of screening', 'knowledge and health beliefs', 'Low cervical cancer screening rates', 'Knowledge and health beliefs']","[{'cui': 'C4505363', 'cui_str': 'Vietnamese Americans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1561452', 'cui_str': 'Vietnamese'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220885', 'cui_str': 'organization'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018701'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer (procedure)'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0814098', 'cui_str': 'Health belief'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",1488.0,0.0239889,"Among women in the intervention group, overall knowledge about cervical cancer and screening guidelines increased from pre- to post-program (30% vs. 88%, p < 0.001), perceived benefits of screening increased (3.50 vs. 4.49, p < 0.001), and perceived barriers to screening decreased (3.13 vs. 2.25, p < 0.001).","[{'ForeName': 'Carolyn Y', 'Initials': 'CY', 'LastName': 'Fang', 'Affiliation': 'Cancer Prevention and Control Program, Fox Chase Cancer Center, 333 Cottman Ave, Philadelphia, PA, 19111, USA. carolyn.fang@fccc.edu.'}, {'ForeName': 'Minsun', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Center for Asian Health, Lewis Katz School of Medicine, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Ziding', 'Initials': 'Z', 'LastName': 'Feng', 'Affiliation': 'Biostatistics Program, The Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'Center for Asian Health, Lewis Katz School of Medicine, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Fayola', 'Initials': 'F', 'LastName': 'Levine', 'Affiliation': 'Hunter College, New York, NY, USA.'}, {'ForeName': 'Cuc', 'Initials': 'C', 'LastName': 'Nguyen', 'Affiliation': 'Asian Community Health Coalition, Philadelphia, PA, USA.'}, {'ForeName': 'Grace X', 'Initials': 'GX', 'LastName': 'Ma', 'Affiliation': 'Department of Clinical Sciences, Center for Asian Health, Lewis Katz School of Medicine, Temple University, Philadelphia, PA, USA.'}]",Journal of community health,['10.1007/s10900-019-00645-6']
849,31889367,"An open-label, randomised controlled trial on the effectiveness of the Orve + wrap ®  versus Forced Air Warming in restoring normothermia in the postanaesthetic care unit.","AIMS AND OBJECTIVES


To determine the clinical effectiveness and safety of the Orve + wrap® thermal blanket.
BACKGROUND


Inadvertent perioperative hypothermia is a common problem in postanaesthetic care units and can have significant effects on patients' postoperative morbidity. Despite its commercial availability, there is no clinical evidence on the effectiveness of Orve + wrap®.
DESIGN


A single centre prospective, open-label, noninferiority randomised controlled trial.
METHODS


Postoperative hypothermic (35.0-35.9°C) patients who had undergone elective surgery were randomised to receive either Orve + wrap® or Forced Air Warming during their PACU stay. Patient temperatures were recorded every 10 min using zero-heat-flux thermometry. This study is reported using CONSORT Extension checklist for noninferiority and equivalence trials.
RESULTS


Between December 2016-October 2018, 129 patients were randomised to receive either Orve + wrap® blanket (n = 65, 50.3%) or Forced Air Warming (n = 64, 49.7%). The mean 60-min postoperative temperature of patients receiving Orve + wrap® blanket was 36.2 and 36.3°C for the patients receiving Forced Air Warming. The predefined noninferiority margin of a mean difference in temperature of 0.3°C was not reached between the groups at 60 min. Additionally, there were no statistical differences between adverse event rates across these groups.
CONCLUSIONS


In the context of this study, warming patients with the Orve + wrap® was noninferior to Forced Air Warming. There were comparable rates of associated postoperative consequences of warming (shivering, hypotension, arrhythmias or surgical site infections), between the groups.
RELEVANCE TO CLINICAL PRACTICE


The Orve + wrap® potentially provides an alternative warming method to Forced Air Warming for patients requiring short-term postoperative warming. However, there are still a number of unknowns regarding the Orve + wrap® performance and further exploration is required.",2020,"There were comparable rates of associated post-operative consequences of warming (shivering, hypotension, arrhythmias or surgical site infections), between the groups.
","['patients requiring short term post-operative warming', 'Between December 2016 and October 2018', 'Post-operative hypothermic (35.0°C - 35.9°C) patients who had undergone elective surgery', '129 patients']","['Orve+wrap® blanket', 'Orve+Wrap® or Forced Air Warming for the during their PACU stay', 'Orve+ Wrap® versus Forced Air Warming', 'Orve+Wrap® thermal blanket']","['rates of associated post-operative consequences of warming (shivering, hypotension, arrhythmias or surgical site infections', 'adverse event rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}]","[{'cui': 'C0179330', 'cui_str': 'Blanket, device (physical object)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0445414', 'cui_str': 'Wrapping (procedure)'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0686907', 'cui_str': 'Consequence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0036973', 'cui_str': 'Shiverings'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",129.0,0.109313,"There were comparable rates of associated post-operative consequences of warming (shivering, hypotension, arrhythmias or surgical site infections), between the groups.
","[{'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Smith', 'Affiliation': 'Hull University Teaching Hospitals NHS Trust, Hull, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Abernethy', 'Affiliation': 'Hull University Teaching Hospitals NHS Trust, Hull, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Allgar', 'Affiliation': 'Hull and York Medical School, York, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Foster', 'Affiliation': 'Hull University Teaching Hospitals NHS Trust, Hull, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Martinson', 'Affiliation': 'Hull University Teaching Hospitals NHS Trust, Hull, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Stones', 'Affiliation': 'Hull University Teaching Hospitals NHS Trust, Hull, UK.'}]",Journal of clinical nursing,['10.1111/jocn.15159']
850,31895881,"A Phase 1 Randomized, Placebo-controlled, Observer-blinded Trial to Evaluate the Safety and Immunogenicity of Inactivated Streptococcus pneumoniae Whole-cell Vaccine in Adults.","BACKGROUND


Broadly protective pneumococcal vaccines that are affordable for low-resource countries are needed. Streptococcus pneumoniae whole cell vaccine (wSp) is an investigational vaccine that contains killed cells from a nonencapsulated strain of S. pneumoniae (SPn) with aluminum hydroxide adjuvant. Studies in mice demonstrated protection against nasopharyngeal carriage (T-cell-mediated) and invasive pneumococcal disease (antibody-mediated). The aim of this randomized, double-blind, placebo-controlled Phase 1 study was to assess safety, tolerability and immunogenicity of wSp in healthy adults.
METHODS


Forty-two participants were randomized into 3 dose cohorts to receive 0.1, 0.3, or 0.6 mg of wSp or saline intramuscularly. Participants received a 3-dose vaccination schedule spaced by 4-week intervals. Postvaccination assessments included solicited reactogenicity events through day 7, blood chemistry and hematology assessments at day 7, and adverse events (AEs) through day 84. Participants were monitored for serum antibody and peripheral blood mononuclear cell cytokine responses to pneumococcal antigens. A 6-month telephone follow-up was completed to assess for any additional AEs.
RESULTS


wSp was safe and well tolerated. Reactogenicity was acceptable and no untoward safety signals were observed. wSp elicited potentially clinically significant rises (defined arbitrarily as at least a 2-fold rise) in immunoglobulin G responses to multiple pneumococcal antigens, including pneumococcal surface protein A and pneumolysin. Functional antibody responses were observed with the highest dose of wSp (0.6 mg). Increases in T-cell cytokine responses, including interleukin 17A, were also seen among wSp vaccines.
CONCLUSIONS


wSp was safe and well tolerated in healthy US adults, eliciting pneumococcal antigen-specific antibody and T-cell cytokine responses.",2020,"wSp elicited potentially clinically significant rises (defined arbitrarily as at least a 2-fold rise) in immunoglobulin G responses to multiple pneumococcal antigens, including pneumococcal surface protein A and pneumolysin.","['healthy adults', 'Forty-two participants', 'healthy US adults', 'Adults']","['aluminum hydroxide adjuvant', 'wSp or saline intramuscularly', 'Placebo', 'placebo', 'Inactivated Streptococcus pneumoniae Whole-cell Vaccine', 'Streptococcus pneumoniae whole cell vaccine (wSp']","['serum antibody and peripheral blood mononuclear cell cytokine responses', 'T-cell cytokine responses', 'Functional antibody responses', 'Reactogenicity', 'solicited reactogenicity events through day 7, blood chemistry and hematology assessments at day 7, and adverse events (AEs', 'safety, tolerability and immunogenicity', 'Safety and Immunogenicity', 'untoward safety signals', 'safe and well tolerated']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0002371', 'cui_str': 'aluminium hydroxide'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C1691781', 'cui_str': 'Reactogenicity event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0005774', 'cui_str': 'Blood Chemical Analysis'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",42.0,0.403336,"wSp elicited potentially clinically significant rises (defined arbitrarily as at least a 2-fold rise) in immunoglobulin G responses to multiple pneumococcal antigens, including pneumococcal surface protein A and pneumolysin.","[{'ForeName': 'Cheryl A', 'Initials': 'CA', 'LastName': 'Keech', 'Affiliation': 'From the PATH, Seattle, Washington.'}, {'ForeName': 'Royce', 'Initials': 'R', 'LastName': 'Morrison', 'Affiliation': 'Clinical Research Consultancy - Design, Medical Monitoring, DMC/DSMB, Safety Assessment, Seattle, Washington.'}, {'ForeName': 'Porter', 'Initials': 'P', 'LastName': 'Anderson', 'Affiliation': ""Boston Children's Hospital, Division of Infectious Diseases, Boston, Massachusetts.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Tate', 'Affiliation': 'From the PATH, Seattle, Washington.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Flores', 'Affiliation': 'From the PATH, Seattle, Washington.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Goldblatt', 'Affiliation': 'Great Ormond Street Institute of Child Biomedical Research Centre, University College London, London, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Briles', 'Affiliation': 'Department of Microbiology, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hural', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Malley', 'Affiliation': ""Boston Children's Hospital, Division of Infectious Diseases, Boston, Massachusetts.""}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Alderson', 'Affiliation': 'From the PATH, Seattle, Washington.'}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000002567']
851,31891437,"The effect of acupressure (GB30) on intramuscular injection pain and satisfaction: Single-blind, randomised controlled study.","AIMS AND OBJECTIVE


To evaluate the effect of acupressure on intramuscular injection pain, satisfaction and vital signs.
BACKGROUND


Pain at the injection site may lead to discomfort and may affect patients' compliance to treatment.
DESIGN


This was a prospective, single-blind, crossover study. The study complied with the guidelines of Consolidated Standards of Reporting Trials (CONSORT) Checklist.
METHODS


Seventy-two healthy volunteer university students received an intramuscular injection of 2 ml sterile saline (%0.9 NaCl) to the ventrogluteal site with and without acupressure on separate days in a random order following a standard procedure by the same investigator. Pain and satisfaction were assessed immediately after the injection with the visual analog scale (VAS) by a researcher blinded to the study.
RESULTS


A total of 134 injections were analysed. The result of the study reveals that acupressure alleviates the severity of pain and increases the patient satisfaction.
CONCLUSIONS


The findings of this research support that use of acupressure, which is easy and cost-effective, could reduce injection pain when performed on a specific point.
RELEVANCE TO CLINICAL PRACTICE


Safe and accurate administration of medications is one of the crucial responsibilities of nurses. Acupressure is a nonpharmacologic approach, which can be effective in decreasing the injection pain and increasing patient satisfaction.",2020,"Acupressure is a non-pharmacologic approach, which can be effective in decreasing the injection pain and increasing patient satisfaction.",['Seventy-two healthy volunteer university students'],"['Acupressure (GB30', 'acupressure', 'Acupressure', 'intramuscular injection of 2 ml sterile saline (%0.9 NaCl) to the ventrogluteal site with and without acupressure']","['Pain and satisfaction', 'injection pain', 'intramuscular injection pain, satisfaction and vital signs', 'severity of pain', 'Visual Analog Scale (VAS', 'Intramuscular Injection Pain and Satisfaction']","[{'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0450750', 'cui_str': 'GB30 (body structure)'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection (procedure)'}, {'cui': 'C0232920', 'cui_str': 'Sterile (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection (procedure)'}, {'cui': 'C0518766'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",72.0,0.132833,"Acupressure is a non-pharmacologic approach, which can be effective in decreasing the injection pain and increasing patient satisfaction.","[{'ForeName': 'Demet', 'Initials': 'D', 'LastName': 'Inangil', 'Affiliation': 'Hamidiye Faculty of Nursing, University of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'Gokhan', 'Initials': 'G', 'LastName': 'Inangil', 'Affiliation': 'Department of Anesthesiology and Reanimation, University of Health Sciences, Sultan Abdülhamid Han Training and Research Hospital, Istanbul, Turkey.'}]",Journal of clinical nursing,['10.1111/jocn.15172']
852,32166833,Neurofunctional correlates of eye to hand motor transfer.,"This work investigates the transfer of motor learning from the eye to the hand and its neural correlates by using functional magnetic resonance imaging (fMRI) and a sensorimotor task consisting of the continuous tracking of a virtual target. In pretraining evaluation, all the participants (experimental and control group) performed the tracking task inside an MRI scanner using their right hand and a joystick. After which, the experimental group practiced an eye-controlled version of the task for 5 days using an eye tracking system outside the MRI environment. Post-training evaluation was done 1 week after the first scanning session, where all the participants were scanned again while repeating the manual pretraining task. Behavioral results show that the training in the eye-controlled task produced a better performance not only in the eye-controlled modality (motor learning) but also in the hand-controlled modality (motor transfer). Neural results indicate that eye to hand motor transfer is supported by the motor cortex, the basal ganglia and the cerebellum, which is consistent with previous research focused on other effectors. These results may be of interest in neurorehabilitation to activate the motor systems and help in the recovery of motor functions in stroke or movement disorder patients.",2020,Behavioral results show that the training in the eye-controlled task produced a better performance not only in the eye-controlled modality (motor learning) but also in the hand-controlled modality (motor transfer).,[],"['functional magnetic resonance imaging (fMRI', 'tracking task inside an MRI scanner using their right hand and a joystick']",['Neurofunctional correlates of eye to hand motor transfer'],[],"[{'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}, {'cui': 'C0344333', 'cui_str': 'Right handed (finding)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}]",,0.0285747,Behavioral results show that the training in the eye-controlled task produced a better performance not only in the eye-controlled modality (motor learning) but also in the hand-controlled modality (motor transfer).,"[{'ForeName': 'Cristián', 'Initials': 'C', 'LastName': 'Modroño', 'Affiliation': 'Departamento de Ciencias Médicas Básicas (Unidad Departamental de Fisiología), Facultad de Ciencias de La Salud, Universidad de La Laguna (ULL), Campus de Ofra, San Cristóbal de La Laguna (S/C de Tenerife), Spain.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Socas', 'Affiliation': 'Servicio de Rehabilitación, Hospital Universitario de Canarias, San Cristóbal de La Laguna (S/C de Tenerife), Spain.'}, {'ForeName': 'Estefanía', 'Initials': 'E', 'LastName': 'Hernández-Martín', 'Affiliation': 'Departamento de Ciencias Médicas Básicas (Unidad Departamental de Fisiología), Facultad de Ciencias de La Salud, Universidad de La Laguna (ULL), Campus de Ofra, San Cristóbal de La Laguna (S/C de Tenerife), Spain.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Plata-Bello', 'Affiliation': 'Departamento de Ciencias Médicas Básicas (Unidad Departamental de Fisiología), Facultad de Ciencias de La Salud, Universidad de La Laguna (ULL), Campus de Ofra, San Cristóbal de La Laguna (S/C de Tenerife), Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Marcano', 'Affiliation': 'Departamento de Ciencias Médicas Básicas (Unidad Departamental de Fisiología), Facultad de Ciencias de La Salud, Universidad de La Laguna (ULL), Campus de Ofra, San Cristóbal de La Laguna (S/C de Tenerife), Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Pérez-González', 'Affiliation': 'Instituto Médico Tinerfeño, San Cristóbal de La Laguna (S/C de Tenerife), Spain.'}, {'ForeName': 'José L', 'Initials': 'JL', 'LastName': 'González-Mora', 'Affiliation': 'Departamento de Ciencias Médicas Básicas (Unidad Departamental de Fisiología), Facultad de Ciencias de La Salud, Universidad de La Laguna (ULL), Campus de Ofra, San Cristóbal de La Laguna (S/C de Tenerife), Spain.'}]",Human brain mapping,['10.1002/hbm.24969']
853,32163578,Serum bicarbonate and cardiovascular events in hypertensive adults: results from the Systolic Blood Pressure Intervention Trial.,"BACKGROUND


Low serum bicarbonate level is associated with increased mortality, but its role as a predictor of cardiovascular disease (CVD) is unclear. This study evaluates the association between serum bicarbonate concentration and CVD and whether the effect of intensive blood pressure (BP) lowering on CVD outcomes is modified by serum bicarbonate level.
METHODS


The Systolic Blood Pressure Intervention Trial (SPRINT) randomized participants to a systolic BP target <120 mmHg (intensive treatment) or <140 mmHg (standard treatment). The primary CVD outcome was a composite of nonfatal myocardial infarction (MI), acute coronary syndrome not resulting in MI, stroke, acute decompensated heart failure and CVD death. Cox proportional hazards models adjusted for demographic, clinical and laboratory characteristics were used to evaluate the association of interest in 9334 SPRINT participants (ClinicalTrials.gov: NCT01206062).
RESULTS


Over a median follow-up of 3.33 years (interquartile range 2.87-3.87 years), 618 (6.6%) participants experienced a primary CVD outcome. Participants with serum bicarbonate <22 mEq/L had a significantly higher risk of the primary CVD outcome (hazard ratio 1.54; 95% confidence interval 1.11-2.14, P = 0.01), compared with participants with bicarbonate 22-26 mEq/L. The magnitude of the CVD risk reduction with intensive BP lowering was similar across bicarbonate strata (P-value for interaction = 0.97).
CONCLUSIONS


In hypertensive individuals, serum bicarbonate level <22 mEq/L was associated with an increased CVD risk. The effect of intensive BP lowering on CVD outcomes was not modified by the serum bicarbonate level.",2019,"Participants with serum bicarbonate <22 mEq/L had a significantly higher risk of the primary CVD outcome (hazard ratio 1.54; 95% confidence interval 1.11-2.14, P = 0.01), compared with participants with bicarbonate 22-26 mEq/L.","['participants to a systolic BP target <120\u2009mmHg (intensive treatment) or <140\u2009mmHg (standard treatment', 'hypertensive adults']","['intensive blood pressure (BP', 'intensive BP lowering']","['CVD outcomes', 'Serum bicarbonate and cardiovascular events', 'composite of nonfatal myocardial infarction (MI), acute coronary syndrome not resulting in MI, stroke, acute decompensated heart failure and CVD death', 'CVD risk', 'risk of the primary CVD outcome', 'serum bicarbonate level']","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}]","[{'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0581377', 'cui_str': 'Decompensated cardiac failure (disorder)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]",9334.0,0.215464,"Participants with serum bicarbonate <22 mEq/L had a significantly higher risk of the primary CVD outcome (hazard ratio 1.54; 95% confidence interval 1.11-2.14, P = 0.01), compared with participants with bicarbonate 22-26 mEq/L.","[{'ForeName': 'Mirela', 'Initials': 'M', 'LastName': 'Dobre', 'Affiliation': 'Division of Nephrology and Hypertension, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Nicholas M', 'Initials': 'NM', 'LastName': 'Pajewski', 'Affiliation': 'Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Beddhu', 'Affiliation': 'Veterans Affairs Salt Lake City Healthcare System, University of Utah Health, Salt Lake City, UT, USA.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': 'Renal Diseases and Hypertension, University of Colorado Denver Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Hostetter', 'Affiliation': 'Division of Nephrology and Hypertension, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'VA Medical Center, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Mahboob', 'Initials': 'M', 'LastName': 'Rahman', 'Affiliation': 'Division of Nephrology and Hypertension, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Servilla', 'Affiliation': 'Nephrology, New Mexico VA Health Care System, Albuquerque, NM, USA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Weiner', 'Affiliation': 'Medicine, Nephrology, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Jackson T', 'Initials': 'JT', 'LastName': 'Wright', 'Affiliation': 'Division of Nephrology and Hypertension, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Kalani L', 'Initials': 'KL', 'LastName': 'Raphael', 'Affiliation': 'Veterans Affairs Salt Lake City Healthcare System, University of Utah Health, Salt Lake City, UT, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfz149']
854,30826452,Rationale and methods for a multicenter clinical trial assessing exercise and intensive vascular risk reduction in preventing dementia (rrAD Study).,"Alzheimer's Disease (AD) is an age-related disease with modifiable risk factors such as hypertension, hypercholesterolemia, obesity, and physical inactivity influencing the onset and progression. There is however, no direct evidence that reducing these risk factors prevents or slows AD. The Risk Reduction for Alzheimer's Disease (rrAD) trial is designed to study the independent and combined effects of intensive pharmacological control of blood pressure and cholesterol and exercise training on neurocognitive function. Six hundred and forty cognitively normal older adults age 60 to 85 years with hypertension and increased risk for dementia will be enrolled. Participants are randomized into one of four intervention group for two years: usual care, Intensive Reduction of Vascular Risk factors (IRVR) with blood pressure and cholesterol reduction, exercise training (EX), and IRVR+EX. Neurocognitive function is measured at baseline, 6, 12, 18, and 24 months; brain MRIs are obtained at baseline and 24 months. We hypothesize that both IRVR and EX will improve global cognitive function, while IRVR+EX will provide a greater benefit than either IRVR or EX alone. We also hypothesize that IRVR and EX will slow brain atrophy, improve brain structural and functional connectivity, and improve brain perfusion. Finally, we will explore the mechanisms by which study interventions impact neurocognition and brain. If rrAD interventions are shown to be safe, practical, and successful, our study will have a significant impact on reducing the risks of AD in older adults. NCT Registration: NCT02913664.",2019,"Neurocognitive function is measured at baseline, 6, 12, 18, and 24 months; brain MRIs are obtained at baseline and 24 months.","['Six hundred and forty cognitively normal older adults age 60 to 85\u202fyears with hypertension and increased risk for dementia will be enrolled', 'older adults']","['IRVR and EX', 'intensive pharmacological control of blood pressure and cholesterol and exercise training', 'usual care, Intensive Reduction of Vascular Risk factors (IRVR) with blood pressure and cholesterol reduction, exercise training (EX), and IRVR+EX']","['brain structural and functional connectivity, and improve brain perfusion', 'global cognitive function', 'Neurocognitive function', 'neurocognitive function']","[{'cui': 'C4708790', 'cui_str': '640'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}]","[{'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}]","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",640.0,0.0386093,"Neurocognitive function is measured at baseline, 6, 12, 18, and 24 months; brain MRIs are obtained at baseline and 24 months.","[{'ForeName': 'Amanda N', 'Initials': 'AN', 'LastName': 'Szabo-Reed', 'Affiliation': ""KU Alzheimer's Disease Center, Fairway, KS, USA; Department of Internal Medicine, University of Kansas Medical Center, Kansas City, KS, USA. Electronic address: aszabo@kumc.edu.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vidoni', 'Affiliation': ""KU Alzheimer's Disease Center, Fairway, KS, USA; Department of Neurology, University of Kansas Medical Center, Kansas City, KS, USA. Electronic address: evidoni@kumc.edu.""}, {'ForeName': 'Ellen F', 'Initials': 'EF', 'LastName': 'Binder', 'Affiliation': 'Department of Internal Medicine, Division of Geriatrics & Nutritional Science, Washington University School of Medicine in St. Louis, St. Louis, MO, USA. Electronic address: ebinder@wustl.edu.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Burns', 'Affiliation': ""KU Alzheimer's Disease Center, Fairway, KS, USA; Department of Neurology, University of Kansas Medical Center, Kansas City, KS, USA. Electronic address: jburns2@kumc.edu.""}, {'ForeName': 'C Munro', 'Initials': 'CM', 'LastName': 'Cullum', 'Affiliation': 'Department of Psychiatry, UT Southwestern Medical Center, Dallas, TX, USA; Department of Neurology & Neurotherapeutics, UT Southwestern Medical Center, Dallas, TX, USA. Electronic address: munro.cullum@utsouthwestern.edu.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Gahan', 'Affiliation': 'Institute for Dementia Research and Prevention, Pennington Biomedical Research Center, Baton Rouge, LA, USA. Electronic address: william.gahan@pbrc.edu.'}, {'ForeName': 'Aditi', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': ""KU Alzheimer's Disease Center, Fairway, KS, USA; Department of Internal Medicine, University of Kansas Medical Center, Kansas City, KS, USA. Electronic address: agupta@kumc.edu.""}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'Hynan', 'Affiliation': 'Department of Psychiatry, UT Southwestern Medical Center, Dallas, TX, USA; Department of Clinical Sciences, UT Southwestern Medical Center, Dallas, TX, USA. Electronic address: Linda.Hynan@utsouthwestern.edu.'}, {'ForeName': 'Diana R', 'Initials': 'DR', 'LastName': 'Kerwin', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, USA; Kerwin Research Center and Memory Care, Dallas, TX, USA. Electronic address: DianaKerwin@texashealth.org.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Rossetti', 'Affiliation': 'Department of Psychiatry, UT Southwestern Medical Center, Dallas, TX, USA. Electronic address: heidi.rossetti@utsouthwestern.edu.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Stowe', 'Affiliation': 'Department of Neurology, University of Kentucky, Lexington, KY, USA. Electronic address: Ann.Stowe@uky.edu.'}, {'ForeName': 'Wanpen', 'Initials': 'W', 'LastName': 'Vongpatanasin', 'Affiliation': 'Institute for Dementia Research and Prevention, Pennington Biomedical Research Center, Baton Rouge, LA, USA. Electronic address: wanpen.vongpatanasin@utsouthwestern.edu.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Zhu', 'Affiliation': 'Department for Radiology, Michigan State University, East Lansing, MI, USA. Electronic address: zhuda@msu.edu.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, USA; Department of Neurology & Neurotherapeutics, UT Southwestern Medical Center, Dallas, TX, USA. Electronic address: RongZhang@texashealth.org.'}, {'ForeName': 'Jeffrey N', 'Initials': 'JN', 'LastName': 'Keller', 'Affiliation': 'Institute for Dementia Research and Prevention, Pennington Biomedical Research Center, Baton Rouge, LA, USA. Electronic address: jeffrey.keller@pbrc.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.02.007']
855,30500075,The JAK1 Inhibitor Upadacitinib Has No Effect on the Pharmacokinetics of Levonorgestrel and Ethinylestradiol: A Study in Healthy Female Subjects.,"Upadacitinib is a novel selective oral Janus kinase 1 (JAK) inhibitor being developed for treatment of several inflammatory diseases. Oral contraceptives are anticipated to be a common concomitant medication in the target patient populations. This study was designed to evaluate the effect of multiple doses of upadacitinib on the pharmacokinetics of ethinylestradiol and levonorgestrel in healthy female subjects. This phase I, single-center, open-label, 2-period crossover study evaluated the effect of multiple doses of 30 mg once daily extended-release upadacitinib on the pharmacokinetics of a single oral dose of ethinylestradiol/levonorgestrel (0.03/0.15 mg; administered alone in period 1 and on day 12 of a 14-day regimen of upadacitinib in period 2) in 22 healthy female subjects. The ratios (90% confidence intervals) for maximum plasma concentration and area under the plasma drug concentration-time curve from time zero to infinity following administration of ethinylestradiol/levonorgestrel with upadacitinib compared with administration of ethinylestradiol/ levonorgestrel alone were 0.96 (0.89-1.02) and 1.1 (1.04-1.19), respectively, for ethinylestradiol, and 0.96 (0.87-1.06) and 0.96 (0.85-1.07), respectively, for levonorgestrel. The harmonic mean terminal half-life for ethinylestradiol (7.7 vs 7.0 hours) and levonorgestrel (37.1 vs 33.1 hours) was similar in the presence and absence of upadacitinib. Ethinylestradiol and levonorgestrel were bioequivalent in the presence and absence of upadacitinib. Therefore, upadacitinib can be administered concomitantly with oral contraceptives containing ethinylestradiol or levonorgestrel.",2019,The harmonic mean terminal half-life for ethinylestradiol (7.7 vs 7.0 hours) and levonorgestrel (37.1 vs 33.1 hours) was similar in the presence and absence of upadacitinib.,"['Healthy Female Subjects', 'healthy female subjects', '22 healthy female subjects']","['levonorgestrel', 'Levonorgestrel and Ethinylestradiol', 'ethinylestradiol and levonorgestrel', 'Ethinylestradiol and levonorgestrel', 'oral contraceptives containing ethinylestradiol or levonorgestrel', 'ethinylestradiol/ levonorgestrel', 'ethinylestradiol/levonorgestrel', 'ethinylestradiol']","['maximum plasma concentration and area under the plasma drug concentration-time curve', 'harmonic mean terminal half-life']","[{'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0717761', 'cui_str': 'Ethinyl Estradiol / Levonorgestrel'}, {'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}, {'cui': 'C0029151', 'cui_str': 'Oral contraception (finding)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}]",22.0,0.0419407,The harmonic mean terminal half-life for ethinylestradiol (7.7 vs 7.0 hours) and levonorgestrel (37.1 vs 33.1 hours) was similar in the presence and absence of upadacitinib.,"[{'ForeName': 'Mohamed-Eslam F', 'Initials': 'MF', 'LastName': 'Mohamed', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Sheryl', 'Initials': 'S', 'LastName': 'Trueman', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Feng', 'Affiliation': 'Data and Statistical Sciences, AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Friedman', 'Affiliation': 'Immunology Development, AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Othman', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie, North Chicago, IL, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1350']
856,30516088,Financial incentives influence ImPACT validity indices but not cognitive composite scores.,"INTRODUCTION


Interpreting change in cognitive performance across baseline and post-concussion evaluations is complicated by poor understanding of how incentives, such as return-to-play, may impact performance. This study examines the influence of an anticipated financial incentive on two sets of outcomes from the ImPACT computerized battery: (a) cognitive composites, meant to serve as measures of cognitive function, and (b) validity indices, proposed as indicators of invalid performance.
METHOD


81 uninjured college students, randomized into two groups, completed a concussion assessment battery including ImPACT. The control group received standard administration instructions. The incentive group was told they would receive $20 if their scores ranked in the top third of students who completed testing. Test examiners were blinded to condition, and participants were debriefed upon study completion.
RESULTS


Given the non-normal distribution of the ImPACT cognitive composites and validity indices, non-parametric statistics were used to compare performance between incentive and control groups. Results of Mann-Whitney U tests revealed no significant differences between groups on the ImPACT cognitive composites (all p > .05, r = .04 to .19). In contrast, compared with the control group, the incentive group performed significantly better on all five validity indices: Impulse Control Composite (p = .036, r = .23); Xs and Os Total Incorrect (p = .035, r = .23); Word Memory Learning Percent Correct (p = .036, r = .23); Design Memory Learning Percent Correct (p = .018, r = .26); and Three Letters Total Letters Correct (p = .027, r = .25).
CONCLUSIONS


Expectation of financial incentive did not influence performance on the four cognitive composites-the ImPACT's standard metrics of cognitive function. However, the incentive group, relative to controls, exhibited better performance on each of the five validity indices. These results suggest that ImPACT validity indices are more sensitive to incentive-related changes in effort than the ImPACT cognitive composites, providing support for the validity indicator indices as measures of effort toward testing.",2019,"In contrast, compared with the control group, the incentive group performed significantly better on all five validity indices: Impulse Control Composite (p = .036, r = .23); Xs and Os Total Incorrect (p = .035, r = .23); Word Memory Learning Percent Correct (p = .036, r = .23); Design Memory Learning Percent Correct (p = .018,",['81 uninjured college students'],"['concussion assessment battery including ImPACT', 'standard administration instructions']","['ImPACT cognitive composites', 'Letters Total Letters Correct', 'validity indices: Impulse Control Composite', 'cognitive performance']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0006107', 'cui_str': 'Cerebral Concussion'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}]","[{'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0443235', 'cui_str': 'Impulse (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",81.0,0.0451869,"In contrast, compared with the control group, the incentive group performed significantly better on all five validity indices: Impulse Control Composite (p = .036, r = .23); Xs and Os Total Incorrect (p = .035, r = .23); Word Memory Learning Percent Correct (p = .036, r = .23); Design Memory Learning Percent Correct (p = .018,","[{'ForeName': 'Victoria C', 'Initials': 'VC', 'LastName': 'Merritt', 'Affiliation': 'a VA San Diego Healthcare System, Psychology Service , San Diego , CA , USA.'}, {'ForeName': 'Amanda R', 'Initials': 'AR', 'LastName': 'Rabinowitz', 'Affiliation': 'b Moss Rehabilitation Research Institute, Brain Injury Neuropsychology Laboratory , Elkins Park , PA , USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Guty', 'Affiliation': 'c Department of Psychology , Penn State University , University Park , PA , USA.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Meyer', 'Affiliation': 'c Department of Psychology , Penn State University , University Park , PA , USA.'}, {'ForeName': 'Liora S', 'Initials': 'LS', 'LastName': 'Greenberg', 'Affiliation': 'c Department of Psychology , Penn State University , University Park , PA , USA.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Arnett', 'Affiliation': 'c Department of Psychology , Penn State University , University Park , PA , USA.'}]",Journal of clinical and experimental neuropsychology,['10.1080/13803395.2018.1551519']
857,31269004,Exercise Intensity Matters in Chronic Nonspecific Low Back Pain Rehabilitation.,"INTRODUCTION


Exercise therapy (ET) is advocated as a treatment for chronic nonspecific low back pain (CNSLBP). However, therapy effect sizes remain low. In other chronic disorders, training at higher intensity has resulted in greater improvements on both general health related and disease specific outcomes compared to lower-intensity ET. Possibly, high-intensity training also improves effect sizes in CNSLBP.
OBJECTIVE


To compare the effects of a high-intensity ET program with a similar moderate-intensity ET program on disability, pain, function, exercise capacity, and abdominal/back muscle strength in persons with CNSLBP.
METHODS


In a randomized controlled trial, persons with CNSLBP performed a 12-wk ET program (24 sessions, 1.5 h per session, twice per week) at high-intensity training (HIT) or moderate-intensity training (MIT). Questionnaires to assess disability (Modified Oswestry Index [MODI]), pain intensity (Numeric Pain Rating Scale), and function (Patient Specific Functioning Scale), a cardiopulmonary exercise test to assess exercise capacity (V˙O2max, cycling time), and a maximum isometric muscle strength test to assess abdominal/back muscle strength (maximum muscle torque) were administered at baseline and after the training program.
RESULTS


Thirty-eight participants (HIT: n = 19, MIT: n = 19) were included (mean age, 44.1 yr, SD = 9.8, 12 males). Groups did not differ at baseline. Between group differences (P < 0.01) in favor of HIT were found for MODI, V˙O2max, and cycling time. Within group improvements (P < 0.01) were found in both groups on MODI (HIT:-64%, MIT:-33%), Numeric Pain Rating Scale (HIT, -56%; MIT, -39%), Patient-Specific Functioning Scale (HIT:+37%, MIT:+39%), V˙O2max (HIT:+14, MIT:+4%), cycling time (HIT:+18%, MIT:+13%), and back muscle strength (HIT:+10%, MIT:+14%).
CONCLUSIONS


High-intensity training proved to be a feasible, well tolerated, and effective therapy modality in CNSLBP. Moreover, it shows greater improvements on disability and exercise capacity than a similar ET performed at moderate intensity.",2019,"Within group improvements (p<0.01) were found in both groups on MODI (HIT:-64%, MIT:-33%), NPRS (HIT:-56%, MIT:-39%), PSFS (HIT:+37%, MIT:+39%), VO2max (HIT:+14, MIT:+4%), cycling time (HIT:+18%, MIT:+13%), and back muscle strength (HIT:+10%, MIT:+14%).
","['persons with CNSLBP performed a 12-week', 'chronic nonspecific low back pain (CNSLBP', 'Chronic Nonspecific Low Back Pain Rehabilitation', 'persons with CNSLBP', 'Thirty-eight participants (HIT: n=19, MIT: n=19) were included (mean age: 44.1y, SD=9.8, 12 males']","['ET program', 'high intensity ET program with a similar moderate intensity ET program', 'Exercise therapy (ET']","['back muscle strength', 'MODI, VO2max, and cycling time', 'cycling time', 'PSFS', 'MODI', 'disability (Modified Oswestry Index (MODI)), pain intensity (Numeric Pain Rating Scale (NPRS)), and function (Patient Specific Functioning Scale (PSFS)), a cardiopulmonary exercise test to assess exercise capacity (VO2max, cycling time), and a maximum isometric muscle strength test to assess abdominal/back muscle strength (maximum muscle torque', 'disability and exercise capacity', 'NPRS', 'disability, pain, function, exercise capacity, and abdominal/back muscle strength']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0596020', 'cui_str': 'Does hit (finding)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}]","[{'cui': 'C0224334', 'cui_str': 'Back Muscles'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0222045'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0376590', 'cui_str': 'Torque'}]",38.0,0.0374012,"Within group improvements (p<0.01) were found in both groups on MODI (HIT:-64%, MIT:-33%), NPRS (HIT:-56%, MIT:-39%), PSFS (HIT:+37%, MIT:+39%), VO2max (HIT:+14, MIT:+4%), cycling time (HIT:+18%, MIT:+13%), and back muscle strength (HIT:+10%, MIT:+14%).
","[{'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Verbrugghe', 'Affiliation': 'REVAL-Rehabilitation Research Center, BIOMED, Hasselt University, Hasselt, BELGIUM.'}, {'ForeName': 'Anouk', 'Initials': 'A', 'LastName': 'Agten', 'Affiliation': 'REVAL-Rehabilitation Research Center, BIOMED, Hasselt University, Hasselt, BELGIUM.'}, {'ForeName': 'Sjoerd', 'Initials': 'S', 'LastName': 'Stevens', 'Affiliation': 'REVAL-Rehabilitation Research Center, BIOMED, Hasselt University, Hasselt, BELGIUM.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Hansen', 'Affiliation': 'REVAL-Rehabilitation Research Center, BIOMED, Hasselt University, Hasselt, BELGIUM.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Demoulin', 'Affiliation': 'Department of Sport and Rehabilitation Sciences, University of Liege, Liege, BELGIUM.'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'O Eijnde', 'Affiliation': 'REVAL-Rehabilitation Research Center, BIOMED, Hasselt University, Hasselt, BELGIUM.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Vandenabeele', 'Affiliation': 'REVAL-Rehabilitation Research Center, BIOMED, Hasselt University, Hasselt, BELGIUM.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Timmermans', 'Affiliation': 'REVAL-Rehabilitation Research Center, BIOMED, Hasselt University, Hasselt, BELGIUM.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002078']
858,31246714,Extended Sleep Maintains Endurance Performance Better than Normal or Restricted Sleep.,"PURPOSE


The cumulative influence of sleep time on endurance performance remains unclear. This study examined the effects of three consecutive nights of both sleep extension (SE) and sleep restriction (SR) on endurance cycling performance.
METHODS


Endurance cyclists/triathletes (n = 9) completed a counterbalanced crossover experiment with three conditions: SR, normal sleep (NS), and SE. Each condition comprised seven days/nights of data collection (-2, -1, D1, D2, D3, D4, and +1). Sleep was monitored using actigraphy throughout. Participants completed testing sessions on days D1-D4 that included an endurance time-trial (TT), mood, and psychomotor vigilance assessment. Perceived exertion (RPE) was monitored throughout each TT. Participants slept habitually before D1; however, time in bed was reduced by 30% (SR), remained normal (NS), or extended by 30% (SE) on nights D1, D2, and D3. Data were analyzed using generalized estimating equations.
RESULTS


On nights D1, D2, and D3, total sleep time was longer (P < 0.001) in the SE condition (8.6 ± 1.0, 8.3 ± 0.6, and 8.2 ± 0.6 h, respectively) and shorter (P < 0.001) in the SR condition (4.7 ± 0.8, 4.8 ± 0.8, and 4.9 ± 0.4 h) compared with NS (7.1 ± 0.8, 6.5 ± 1.0, and 6.9 ± 0.7 h). Compared with NS, TT performance was slower (P < 0.02) on D3 of SR (58.8 ± 2.5 vs 60.4 ± 3.7 min) and faster (P < 0.02) on D4 of SE (58.7 ± 3.4 vs 56.8 ± 3.1 min). RPE was not different between or within conditions. Compared with NS, mood disturbance was higher, and psychomotor vigilance impaired, after SR. Compared with NS, psychomotor vigilance improved after SE.
CONCLUSION


Sleep extension for three nights led to better maintenance of endurance performance compared with normal and restricted sleep. Sleep restriction impaired performance. Cumulative sleep time affects performance by altering the perceived exertion of a given exercise intensity. Endurance athletes should sleep >8 h per night to optimize performance.",2019,"Compared with NS, TT performance was slower (P<0.02) on D3 of SR (58.8±2.5 vs 60.4±3.7min) and faster (P<0.02) on D4 of SE (58.7±3.4 vs 56.8±3.1min).",['Endurance cyclists/triathletes (n=9'],[],"['Sleep restriction impaired performance', 'Sleep', 'Perceived exertion (RPE', 'psychomotor vigilance', 'nights D1, D2, and D3, total sleep time', 'mood disturbance was higher-, and psychomotor vigilance', 'endurance time-trial (TT), mood, and psychomotor vigilance assessment', 'endurance performance', 'sleep restriction (SR), normal sleep (NS), and sleep extension (SE', 'TT performance', 'RPE', 'D3 of SR']","[{'cui': 'C0518031', 'cui_str': 'Endurance capacity'}]",[],"[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}]",,0.063852,"Compared with NS, TT performance was slower (P<0.02) on D3 of SR (58.8±2.5 vs 60.4±3.7min) and faster (P<0.02) on D4 of SE (58.7±3.4 vs 56.8±3.1min).","[{'ForeName': 'Spencer S H', 'Initials': 'SSH', 'LastName': 'Roberts', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition, Deakin University, Burwood, Victoria, AUSTRALIA.'}, {'ForeName': 'Wei-Peng', 'Initials': 'WP', 'LastName': 'Teo', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition, Deakin University, Burwood, Victoria, AUSTRALIA.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Aisbett', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition, Deakin University, Burwood, Victoria, AUSTRALIA.'}, {'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'Warmington', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition, Deakin University, Burwood, Victoria, AUSTRALIA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002071']
859,30634036,"Blood pressure checks and diagnosing hypertension (BP-CHECK): Design and methods of a randomized controlled diagnostic study comparing clinic, home, kiosk, and 24-hour ambulatory BP monitoring.","BACKGROUND


The US Preventive Services Task Force recommends out-of-office blood pressure (BPs) before making a new diagnosis of hypertension, using 24-h ambulatory (ABPM) or home BP monitoring (HBPM), however this is not common in routine clinical practice. Blood Pressure Checks and Diagnosing Hypertension (BP-CHECK) is a randomized controlled diagnostic study assessing the comparability and acceptability of clinic, home, and kiosk-based BP monitoring to ABPM for diagnosing hypertension. Stakeholders including patients, providers, policy makers, and researchers informed the study design and protocols.
METHODS


Adults aged 18-85 without diagnosed hypertension and on no hypertension medication with elevated BPs in clinic and at the baseline research visit are randomized to one of 3 regimens for diagnosing hypertension: (1) clinic BPs, (2) home BPs, or (3) kiosk BPs; all participants subsequently complete ABPM. The primary outcomes are the comparability (with daytime ABPM mean systolic and diastolic BP as the reference standard) and acceptability (e.g., adherence to, patient-reported outcomes) of each method compared to ABPM. Longer-term outcomes are assessed at 6-months including: patient-reported outcomes, primary care providers' diagnosis of hypertension; and BP control. We report challenges experienced and our response to these.
RESULTS


Enrollment began in May of 2017 with a target of randomizing 510 participants. BP thresholds for diagnosing hypertension in the US changed after the trial started. We discuss the stakeholder process used to assess and respond to these changes.
CONCLUSION AND PUBLIC HEALTH IMPACT


BP-CHECK will inform which hypertension diagnostic methods are most accurate, acceptable, and feasible to implement in primary care.",2019,"Blood Pressure Checks and Diagnosing Hypertension (BP-CHECK) is a randomized controlled diagnostic study assessing the comparability and acceptability of clinic, home, and kiosk-based BP monitoring to ABPM for diagnosing hypertension.","['Adults aged 18-85 without diagnosed hypertension and on no hypertension medication with elevated BPs in clinic and at the baseline research visit', 'Enrollment began in May of 2017 with a target of randomizing 510 participants']",['24-h ambulatory (ABPM) or home BP monitoring (HBPM'],"['Blood Pressure Checks', 'Blood pressure checks', ""patient-reported outcomes, primary care providers' diagnosis of hypertension; and BP control"", 'comparability (with daytime ABPM mean systolic and diastolic BP as the reference standard) and acceptability (e.g., adherence to, patient-reported outcomes) of each method compared to ABPM']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0497247', 'cui_str': 'Finding of increased blood pressure (finding)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0035168'}, {'cui': 'C4517800', 'cui_str': '510 (qualifier value)'}]","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0649948', 'cui_str': 'HBPM'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider (occupation)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0034925', 'cui_str': 'Reference Standards'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]",510.0,0.0605219,"Blood Pressure Checks and Diagnosing Hypertension (BP-CHECK) is a randomized controlled diagnostic study assessing the comparability and acceptability of clinic, home, and kiosk-based BP monitoring to ABPM for diagnosing hypertension.","[{'ForeName': 'Beverly B', 'Initials': 'BB', 'LastName': 'Green', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, United States; Kaiser Permanente Washington Medical Group, United States. Electronic address: Bev.B.Green@kp.org.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Anderson', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, United States.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Campbell', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, United States.'}, {'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Cook', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, United States.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Ehrlich', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, United States.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Evers', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, United States.'}, {'ForeName': 'Yoshio N', 'Initials': 'YN', 'LastName': 'Hall', 'Affiliation': 'Kidney Research Institute, University of Washington Department of Medicine, United States.'}, {'ForeName': 'Clarissa', 'Initials': 'C', 'LastName': 'Hsu', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, United States.'}, {'ForeName': 'Dwayne', 'Initials': 'D', 'LastName': 'Joseph', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, United States.'}, {'ForeName': 'Predrag', 'Initials': 'P', 'LastName': 'Klasnja', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, United States.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Margolis', 'Affiliation': 'HealthPartners Institute, United States.'}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'McClure', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, United States.'}, {'ForeName': 'Sean A', 'Initials': 'SA', 'LastName': 'Munson', 'Affiliation': 'University of Washington, Department of Human Centered Design and Engineering, United States.'}, {'ForeName': 'Mathew J', 'Initials': 'MJ', 'LastName': 'Thompson', 'Affiliation': 'University of Washington, Department of Family Medicine, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.01.003']
860,32181756,"Safety, tolerability, and immunogenicity of influenza vaccination with a high-density microarray patch: Results from a randomized, controlled phase I clinical trial.","BACKGROUND


The Vaxxas high-density microarray patch (HD-MAP) consists of a high density of microprojections coated with vaccine for delivery into the skin. Microarray patches (MAPs) offer the possibility of improved vaccine thermostability as well as the potential to be safer, more acceptable, easier to use, and more cost-effective for the administration of vaccines than injection by needle and syringe (N&S). Here, we report a phase I trial using the Vaxxas HD-MAP to deliver a monovalent influenza vaccine that was to the best of our knowledge the first clinical trial to evaluate the safety, tolerability, and immunogenicity of lower doses of influenza vaccine delivered by MAPs.
METHODS AND FINDINGS


HD-MAPs were coated with a monovalent, split inactivated influenza virus vaccine containing A/Singapore/GP1908/2015 H1N1 haemagglutinin (HA). Between February 2018 and March 2018, 60 healthy adults (age 18-35 years) in Melbourne, Australia were enrolled into part A of the study and vaccinated with either: HD-MAPs delivering 15 μg of A/Singapore/GP1908/2015 H1N1 HA antigen (A-Sing) to the volar forearm (FA); uncoated HD-MAPs; intramuscular (IM) injection of commercially available quadrivalent influenza vaccine (QIV) containing A/Singapore/GP1908/2015 H1N1 HA (15 μg/dose); or IM injection of H1N1 HA antigen (15 μg/dose). After 22 days' follow-up and assessment of the safety data, a further 150 healthy adults were enrolled and randomly assigned to 1 of 9 treatment groups. Participants (20 per group) were vaccinated with HD-MAPs delivering doses of 15, 10, 5, 2.5, or 0 μg of HA to the FA or 15 μg HA to the upper arm (UA), or IM injection of QIV. The primary objectives of the study were safety and tolerability. Secondary objectives were to assess the immunogenicity of the influenza vaccine delivered by HD-MAP. Primary and secondary objectives were assessed for up to 60 days post-vaccination. Clinical staff and participants were blind as to which HD-MAP treatment was administered and to administration of IM-QIV-15 or IM-A/Sing-15. All laboratory investigators were blind to treatment and participant allocation. Two further groups in part B (5 participants per group), not included in the main safety and immunological analysis, received HD-MAPs delivering 15 μg HA or uncoated HD-MAPs applied to the forearm. Biopsies were taken on days 1 and 4 for analysis of the cellular composition from the HD-MAP application sites. The vaccine coated onto HD-MAPs was antigenically stable when stored at 40°C for at least 12 months. HD-MAP vaccination was safe and well tolerated; any systemic or local adverse events (AEs) were mild or moderate. Observed systemic AEs were mostly headache or myalgia, and local AEs were application-site reactions, usually erythema. HD-MAP administration of 2.5 μg HA induced haemagglutination inhibition (HAI) and microneutralisation (MN) titres that were not significantly different to those induced by 15 μg HA injected IM (IM-QIV-15). HD-MAP delivery resulted in enhanced humoral responses compared with IM injection with higher HAI geometric mean titres (GMTs) at day 8 in the MAP-UA-15 (GMT 242.5, 95% CI 133.2-441.5), MAP-FA-15 (GMT 218.6, 95% CI 111.9-427.0), and MAP-FA-10 (GMT 437.1, 95% CI 254.3-751.3) groups compared with IM-QIV-15 (GMT 82.8, 95% CI 42.4-161.8), p = 0.02, p = 0.04, p < 0.001 for MAP-UA-15, MAP-FA-15, and MAP-FA-10, respectively. Higher titres were also observed at day 22 in the MAP-FA-10 (GMT 485.0, 95% CI 301.5-780.2, p = 0.001) and MAP-UA-15 (367.6, 95% CI 197.9-682.7, p = 0.02) groups compared with the IM-QIV-15 group (GMT 139.3, 95% CI 79.3-244.5). Results from a panel of exploratory immunoassays (antibody-dependent cellular cytotoxicity, CD4+ T-cell cytokine production, memory B cell (MBC) activation, and recognition of non-vaccine strains) indicated that, overall, Vaxxas HD-MAP delivery induced immune responses that were similar to, or higher than, those induced by IM injection of QIV. The small group sizes and use of a monovalent influenza vaccine were limitations of the study.
CONCLUSIONS


Influenza vaccine coated onto the HD-MAP was stable stored at temperatures up to 40°C. Vaccination using the HD-MAP was safe and well tolerated and resulted in immune responses that were similar to or significantly enhanced compared with IM injection. Using the HD-MAP, a 2.5 μg dose (1/6 of the standard dose) induced HAI and MN titres similar to those induced by 15 μg HA injected IM.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry (ANZCTR.org.au), trial ID 108 ACTRN12618000112268/U1111-1207-3550.",2020,Vaccination using the HD-MAP was safe and well tolerated and resulted in immune responses that were similar to or significantly enhanced compared with IM injection.,"['150 healthy adults', 'Between February 2018 and March 2018, 60 healthy adults (age 18-35 years) in Melbourne, Australia were enrolled into part A of the study and vaccinated with either']","['IM-QIV-15 or IM-A/Sing-15', 'monovalent, split inactivated influenza virus vaccine containing A/Singapore/GP1908/2015 H1N1 haemagglutinin (HA', 'HD-MAPs delivering 15 μg of A/Singapore/GP1908/2015 H1N1 HA antigen (A-Sing) to the volar forearm (FA); uncoated HD-MAPs; intramuscular (IM) injection of commercially available quadrivalent influenza vaccine (QIV) containing A/Singapore/GP1908/2015 H1N1 HA (15 μg/dose); or IM injection of H1N1 HA antigen', 'HD-MAPs delivering 15 μg HA or uncoated HD-MAPs applied to the forearm', 'influenza vaccine delivered by MAPs', 'HD-MAP vaccination', 'influenza vaccination with a high-density microarray patch', 'Influenza vaccine']","['MAP-UA-15', 'immunogenicity of the influenza vaccine delivered by HD-MAP', 'safety, tolerability, and immunogenicity', 'safety and tolerability', 'HAI and MN titres', 'Safety, tolerability, and immunogenicity', 'HAI geometric mean titres (GMTs', 'safe and well tolerated; any systemic or local adverse events (AEs', 'Higher titres', 'humoral responses', 'cellular cytotoxicity, CD4+ T-cell cytokine production, memory B cell (MBC) activation, and recognition of non-vaccine strains', 'safe and well tolerated', 'haemagglutination inhibition (HAI) and microneutralisation (MN) titres']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0580264', 'cui_str': 'H1N1'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0443349', 'cui_str': 'Volar (qualifier value)'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection (procedure)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C4318638', 'cui_str': 'Quadrivalent Influenza Vaccine'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination (procedure)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}]","[{'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0033268'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination Inhibition Tests'}]",60.0,0.129819,Vaccination using the HD-MAP was safe and well tolerated and resulted in immune responses that were similar to or significantly enhanced compared with IM injection.,"[{'ForeName': 'Angus H', 'Initials': 'AH', 'LastName': 'Forster', 'Affiliation': 'Vaxxas Pty Ltd, Brisbane, Queensland, Australia.'}, {'ForeName': 'Katey', 'Initials': 'K', 'LastName': 'Witham', 'Affiliation': 'Vaxxas Pty Ltd, Brisbane, Queensland, Australia.'}, {'ForeName': 'Alexandra C I', 'Initials': 'ACI', 'LastName': 'Depelsenaire', 'Affiliation': 'Vaxxas Pty Ltd, Brisbane, Queensland, Australia.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Veitch', 'Affiliation': 'The University of Queensland Diamantina Institute, Faculty of Medicine, The University of Queensland, TRI, Brisbane, Queensland, Australia.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Wells', 'Affiliation': 'The University of Queensland Diamantina Institute, Faculty of Medicine, The University of Queensland, TRI, Brisbane, Queensland, Australia.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Wheatley', 'Affiliation': 'Department of Microbiology and Immunology, University of Melbourne, at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Pryor', 'Affiliation': '360biolabs, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Lickliter', 'Affiliation': 'Nucleus Network Pty Ltd, Melbourne, Victoria, Australia.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Francis', 'Affiliation': 'Avance Clinical Pty Ltd, Thebarton, South Australia, Australia.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Rockman', 'Affiliation': 'Department of Microbiology and Immunology, University of Melbourne, at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Bodle', 'Affiliation': 'Seqirus Pty Ltd, Parkville, Victoria, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Treasure', 'Affiliation': 'Peter Treasure Statistical Services Ltd, Kings Lynn, United Kingdom.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Hickling', 'Affiliation': 'Working in Tandem Ltd, Cambridge, United Kingdom.'}, {'ForeName': 'Germain J P', 'Initials': 'GJP', 'LastName': 'Fernando', 'Affiliation': 'Vaxxas Pty Ltd, Brisbane, Queensland, Australia.'}]",PLoS medicine,['10.1371/journal.pmed.1003024']
861,31977520,"Dexamethasone Dose and Early Postoperative Recovery after Mastectomy: A Double-blind, Randomized Trial.","BACKGROUND


Pain and nausea are the most common challenges in postoperative recovery after mastectomy. Preventive measures include multimodal analgesia with preoperative glucocorticoid. The aim of this study was to investigate whether 24 mg of preoperative dexamethasone was superior to 8 mg on early recovery after mastectomy in addition to a simple analgesic protocol.
METHODS


In a randomized, double-blind trial, patients 18 yr of age or older having mastectomy were randomized 1:1 to 24 mg or 8 mg dexamethasone, and all received a standardized anesthetic and surgical protocol with preoperative acetaminophen, total intravenous anesthesia, and local anesthetic wound infiltration. The primary endpoint was number of patients transferred to the postanesthesia care unit according to standardized discharge criteria (modified Aldrete score). Secondary endpoints included pain and nausea at extubation, transfer from the operating room and upon arrival at the ward, length of stay, seroma occurrence, and wound infections.
RESULTS


One hundred thirty patients (65 in each group) were included and analyzed for the primary outcome. Twenty-three (35%) in each group met the primary outcome, without significant differences in standardized discharge scores (odds ratio, 1.00 [95% CI, 0.49 to 2.05], P > 0.999). More patients had seroma requiring drainage in the 24 mg versus 8 mg group, 94% versus 81%, respectively (odds ratio, 3.53 [95% CI, 1.07 to 11.6], P = 0.030). Median pain scores were low at all measured time points, numeric rating scale less than or equal to 2 versus less than or equal to 1 in the 24 mg versus 8 mg group, respectively. Six patients in each group (9%) experienced nausea at any time during hospital stay (P > 0.999). Length of stay was median 11 and 9.2 h in the 24 and 8 mg group, respectively (P = 0.217).
CONCLUSIONS


The authors found no evidence of 24 mg versus 8 mg of dexamethasone affecting the primary outcome regarding immediate recovery after mastectomy. The authors observed a short length of stay and low pain scores despite a simple analgesic protocol.",2020,"More patients had seroma requiring drainage in the 24 mg versus 8 mg group, 94% versus 81%, respectively (odds ratio, 3.53 [95% CI, 1.07 to 11.6], P = 0.030).","['Mastectomy', 'patients 18 yr of age or older having mastectomy', 'One hundred thirty patients (65 in each group']","['dexamethasone', 'preoperative glucocorticoid', 'groupsDexamethasone', 'Dexamethasone', 'standardized anesthetic and surgical protocol with preoperative acetaminophen, total intravenous anesthesia, and local anesthetic wound infiltration', 'preoperative dexamethasone']","['short length of stay and low pain scores', 'number of patients transferred to the postanesthesia care unit according to standardized discharge criteria (modified Aldrete score', 'pain and nausea at extubation, transfer from the operating room and upon arrival at the ward, length of stay, seroma occurrence, and wound infections', 'standardized discharge scores', 'Pain and nausea', 'nausea at any time during hospital stay', 'Median pain scores', 'Length of stay', 'immediate recovery', 'seroma requiring drainage']","[{'cui': 'C0024886', 'cui_str': 'Total Mastectomy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia (procedure)'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0394871', 'cui_str': 'Wound infiltration (procedure)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030704', 'cui_str': 'Patient Transfer'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care (regime/therapy)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3164884', 'cui_str': 'Modified Aldrete score (assessment scale)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0029064', 'cui_str': 'Operating Room'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0043241', 'cui_str': 'Wound Infection'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}]",130.0,0.497911,"More patients had seroma requiring drainage in the 24 mg versus 8 mg group, 94% versus 81%, respectively (odds ratio, 3.53 [95% CI, 1.07 to 11.6], P = 0.030).","[{'ForeName': 'Kristin Julia', 'Initials': 'KJ', 'LastName': 'Steinthorsdottir', 'Affiliation': 'From the Department of Anesthesiology, Centre for Cancer and Organ Diseases (K.J.S., H.N.A., E.K.A.) Surgical Pathophysiology Unit (K.J.S., H.K.) Department of Anesthesiology, Centre of Head and Orthopaedics (H.A.), Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark Department of Breast Surgery, Herlev/Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark (N.K.).'}, {'ForeName': 'Hussein Nasser', 'Initials': 'HN', 'LastName': 'Awada', 'Affiliation': ''}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Abildstrøm', 'Affiliation': ''}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Kroman', 'Affiliation': ''}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Kehlet', 'Affiliation': ''}, {'ForeName': 'Eske', 'Initials': 'E', 'LastName': 'Kvanner Aasvang', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003112']
862,31833004,Low-level laser-aided orthodontic treatment of periodontally compromised patients: a randomised controlled trial.,"Low-level laser irradiation (LLLI) shows effects in orthodontic pain relief and periodontal inflammation control. The aim of this article is to investigate the analgesic and inflammation-modulatory effects of low-level laser irradiation among orthodontic patients with compromised periodontium. A randomised controlled trial with split-mouth design was conducted in 27 adults with treated and controlled chronic periodontitis over 6 months. One side of the dental arch underwent repeated treatment under a 940-nm diode laser (EZlase; Biolase Technology Inc.) with a beam size of 2.8 cm 2  for 60 seconds at 8.6 J/cm 2 , whilst the other side received pseudo-laser treatment. Laser irradiation was applied repeatedly for 8 times during the first 6 weeks after bracket bonding and monthly thereafter until the end of orthodontic treatment. Subjective pain (assessed by visual analogue scale in pain diary and by chairside archwire activation), periodontal status (assessed by periodontal clinical parameters), cytokines in gingival crevicular fluid (interleukin 1β, prostaglandin E 2 , substance P) and periodontopathic bacteria (Porphyromonas gingivalis and Treponema denticola) in supragingival plaque were assessed. The intensity of pain was lower on the laser-irradiated side at multiple follow-up visits (P < 0.05). The pain subsided 1 day earlier on the laser side, with a lower peak value during the first week after initial archwire placement (P < 0.05). The laser side exhibited a smaller reduction in bite force during the first month (mean difference = 3.17, 95% CI: 2.36-3.98, P < 0.05 at 1-week interval; mean difference = 3.09, 95% CI: 1.87-4.32, P < 0.05 at 1-month interval). A smaller increase was observed in the plaque index scores on the laser side at 1-month (mean difference = 0.19, 95% CI: 0.13-0.24, P < 0.05) and in the gingival index scores at the 3-month follow-up visit (mean difference = 0.18, 95% CI: 0.14-0.21, P < 0.05). Laser irradiation inhibited the elevation of interleukin-1β, prostaglandin E 2  and substance P levels during the first month (P < 0.05). However, no intergroup difference was detected in the bacteria levels. Low-level laser irradiation exhibits benefits in pain relief and inflammation control during the early stage of adjunctive orthodontic treatment in periodontally compromised individuals.",2020,"Laser irradiation inhibited the elevation of interleukin-1β, prostaglandin E 2  and substance P levels during the first month (P < 0.05).","['periodontally compromised individuals', 'periodontally compromised patients', 'orthodontic patients with compromised periodontium', '27 adults with treated and controlled chronic periodontitis over 6 months']","['Low-level laser irradiation (LLLI', 'Laser irradiation', 'low-level laser irradiation', 'Low-level laser irradiation', '940-nm diode laser (EZlase; Biolase Technology Inc.) with a beam size of 2.8 cm 2  for 60 seconds at 8.6 J/cm 2 , whilst the other side received pseudo-laser treatment', 'Low-level laser-aided orthodontic treatment']","['gingival index scores', 'bacteria levels', 'bite force', 'Subjective pain (assessed by visual analogue scale in pain diary and by chairside archwire activation), periodontal status (assessed by periodontal clinical parameters), cytokines in gingival crevicular fluid (interleukin 1β, prostaglandin E 2 , substance P) and periodontopathic bacteria (Porphyromonas gingivalis and Treponema denticola) in supragingival plaque', 'intensity of pain', 'elevation of interleukin-1β, prostaglandin E 2  and substance P levels', 'plaque index scores']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0031104', 'cui_str': 'Tooth Supporting Structures'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0266929', 'cui_str': 'Adult Periodontitis'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C4517905', 'cui_str': '940'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor Diode Lasers'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C4517879', 'cui_str': '8.6 (qualifier value)'}, {'cui': 'C0205237', 'cui_str': 'False (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}]","[{'cui': 'C0017569', 'cui_str': 'Gingival Index'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005654', 'cui_str': 'Occlusal Force'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0451366', 'cui_str': 'Pain diary (assessment scale)'}, {'cui': 'C0444744', 'cui_str': 'Chairside (environment)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0033559', 'cui_str': 'PGE'}, {'cui': 'C0038585', 'cui_str': 'Euler-Gaddum Substance P'}, {'cui': 'C0206347', 'cui_str': 'Porphyromonas'}, {'cui': 'C0318222', 'cui_str': 'Treponema denticola'}, {'cui': 'C0399452', 'cui_str': 'Supragingival dental plaque (disorder)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",27.0,0.0672846,"Laser irradiation inhibited the elevation of interleukin-1β, prostaglandin E 2  and substance P levels during the first month (P < 0.05).","[{'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Ren', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, 34 Hospital Road, Sai Ying Pun, Hong Kong, SAR, China.'}, {'ForeName': 'Colman', 'Initials': 'C', 'LastName': 'McGrath', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, 34 Hospital Road, Sai Ying Pun, Hong Kong, SAR, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Gu', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, 34 Hospital Road, Sai Ying Pun, Hong Kong, SAR, China.'}, {'ForeName': 'Lijian', 'Initials': 'L', 'LastName': 'Jin', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, 34 Hospital Road, Sai Ying Pun, Hong Kong, SAR, China.'}, {'ForeName': 'Chengfei', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, 34 Hospital Road, Sai Ying Pun, Hong Kong, SAR, China.'}, {'ForeName': 'Fung Hou Kumoi Mineaki Howard', 'Initials': 'FHKMH', 'LastName': 'Sum', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, 34 Hospital Road, Sai Ying Pun, Hong Kong, SAR, China.'}, {'ForeName': 'Ka Wai Frank', 'Initials': 'KWF', 'LastName': 'Wong', 'Affiliation': ""Department of Health, HKSAR Government, Hong Kong, SAR, People's Republic of China.""}, {'ForeName': 'Anson Cheuk Man', 'Initials': 'ACM', 'LastName': 'Chau', 'Affiliation': ""The Universiry of Hong Kong - Shenzhen Hospital Ltd., The University of Hong Kong, The Universiry of Hong Kong - Shenzhen Hospital Ltd., Shenzhen, 518053, People's Republic of China.""}, {'ForeName': 'Yanqi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, 34 Hospital Road, Sai Ying Pun, Hong Kong, SAR, China. yangyanq@hku.hk.'}]",Lasers in medical science,['10.1007/s10103-019-02923-0']
863,31964660,Does intensive glycaemic control promote healing in diabetic foot ulcers? - a feasibility study.,"INTRODUCTION


One in four diabetes patients will develop a foot ulcer over their lifetime. The role of glycaemic control in the healing of foot ulcers in diabetes patients is not supported by randomised controlled trial (RCT) data.
OBJECTIVES


To determine the feasibility of an RCT of glycaemic control with intensive insulin therapy in diabetic foot ulcer, by assessing: entry criteria, fasting capillary blood glucose (FCBG) medication satisfaction and sensitivity of different ulcer-healing endpoints to glycaemic control.
DESIGN


Two substudies: one cross-sectional and one single-arm prospective.
SETTING


Single-centre secondary care diabetic foot clinic in New Zealand.
PARTICIPANTS


Substudy 1: 78 participants consisting of all people ≥18 years with a diabetic foot ulcer presenting to the clinic over 35 weeks in 2015.Substudy 2: 15 participants from Substudy 1 consenting to intensive insulin therapy.
INTERVENTION


Substudy 1: None.Substudy 2: Intensive insulin therapy with standard podiatry care over 24 weeks.
OUTCOME


Substudy 1: Proportion of participants satisfying potential RCT entry criteria; medication satisfaction (Diabetes Medication Satisfaction).Substudy 2: FCBG, index ulcer healing time, index ulcer size, health-related quality of life (HRQoL; EuroQol 5 Dimensions 5 Levels and Diabetic Foot Ulcer Scale-Short Form).
RESULTS


Proportion in Substudy 1 satisfying all entry criteria was 31% (95% CI 21 to 42). FCBG values decreased between baseline and study end (difference -3.7 mmol/L, 95% CI -6.5 to -0.8); 83% (95% CI 44 to 95) of ulcers healed by 24 weeks. FCBG correlated negatively with medication satisfaction. Ulcer area logarithm was most sensitive to FCBG changes, displaying significant negative correlation with HRQoL outcomes. Detecting a 30% between-group difference in this outcome (80% power, α=5%) requires 220 participants per arm, achievable within 1 year with 15 centres similar to study setting.
CONCLUSIONS


An adequately powered RCT requires cooperation between a large number of centres. Ulcer area logarithm should be primary endpoint.
TRIAL REGISTRATION NUMBER


ANZCTR ACTRN12617001414303.",2020,"FCBG values decreased between baseline and study end (difference -3.7 mmol/L, 95% CI -6.5 to -0.8); 83% (95% CI 44 to 95) of ulcers healed by 24 weeks.","['Single-centre secondary care diabetic foot clinic in New Zealand', 'Substudy 1: 78 participants consisting of all people ≥18 years with a diabetic foot ulcer presenting to the clinic over 35 weeks in 2015.Substudy 2: 15 participants from Substudy 1 consenting to', 'diabetes patients']","['FCBG', 'intensive insulin therapy', 'Intensive insulin therapy with standard podiatry care over 24 weeks']","['FCBG values', 'fasting capillary blood glucose (FCBG) medication satisfaction and sensitivity of different ulcer-healing endpoints', 'Proportion of participants satisfying potential RCT entry criteria; medication satisfaction (Diabetes Medication Satisfaction).Substudy 2: FCBG, index ulcer healing time, index ulcer size, health-related quality of life (HRQoL; EuroQol 5 Dimensions 5 Levels and Diabetic Foot Ulcer Scale-Short Form']","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0206172', 'cui_str': 'Diabetic Foot'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer (disorder)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032331', 'cui_str': 'Chiropody'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood (substance)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer (disorder)'}, {'cui': 'C0222045'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}]",,0.0809917,"FCBG values decreased between baseline and study end (difference -3.7 mmol/L, 95% CI -6.5 to -0.8); 83% (95% CI 44 to 95) of ulcers healed by 24 weeks.","[{'ForeName': 'Ajith', 'Initials': 'A', 'LastName': 'Dissanayake', 'Affiliation': 'Endocrinology and Diabetes, Counties Manukau District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Alain C', 'Initials': 'AC', 'LastName': 'Vandal', 'Affiliation': 'Department of Statistics, University of Auckland, Auckland, New Zealand alain.vandal@auckland.ac.nz.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Boyle', 'Affiliation': 'Endocrinology and Diabetes, Counties Manukau District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Park', 'Affiliation': 'Faculty of Health and Environmental Sciences, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Bobbie', 'Initials': 'B', 'LastName': 'Milne', 'Affiliation': 'Middlemore Clinical Trials, Auckland, New Zealand.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Grech', 'Affiliation': 'Podiatry, Counties Manukau Health, Auckland, New Zealand.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Ng', 'Affiliation': 'Podiatry, Counties Manukau Health, Auckland, New Zealand.'}]",BMJ open,['10.1136/bmjopen-2019-029009']
864,31988225,Dynamic LED-light versus static LED-light for depressed inpatients: study protocol for a randomised clinical study.,"INTRODUCTION


Retrospective studies conducted in psychiatric inpatient wards have shown a relation between the intensity of daylight in patient rooms and the length of stay, pointing to an antidepressant effect of ambient lighting conditions. Light therapy has shown a promising antidepressant effect when administered from a light box. The emergence of light-emitting diode (LED) technology has made it possible to build luminaires into rooms and to dynamically mimic the spectral and temporal distribution of daylight. The objective of this study is to investigate the antidepressant efficacy of a newly developed dynamic LED-lighting system installed in an inpatient ward.
METHODS AND ANALYSIS


In all, 150 inpatients with a major depressive episode, as part of either a major depressive disorder or as part of a bipolar disorder, will be included. The design is a two-arm 1:1 randomised study with a dynamic LED-lighting arm and a static LED-lighting arm, both as add-on to usual treatment in an inpatient psychiatric ward. The primary outcome is the baseline adjusted score on the 6-item Hamilton Depression Rating Scale at week 3. The secondary outcomes are the mean score on the Suicidal Ideation Attributes Scale at week 3, the mean score on the 17-item Hamilton Depression Rating Scale at week 3 and the mean score on the World Health Organisation Quality of Life-BREF (WHOQOL-BREF) at week 3. The spectral distribution of daylight and LED-light, with a specific focus on light mediated through the intrinsically photosensitive retinal ganglion cells, will be measured. Use of light luminaires will be logged. Assessors of Hamilton Depression Rating Scale scores and data analysts will be blinded for treatment allocation. The study was initiated in May 2019 and will end in December 2021.
ETHICS AND DISSEMINATION


No ethical issues are expected. Results will be published in peer-reviewed journals, disseminated electronically and in print and presented at symposia.
TRIAL REGISTRATION NUMBER


NCT03821506; Pre-results.",2020,No ethical issues are expected.,"['150 inpatients with a major depressive episode, as part of either a major depressive disorder or as part of a bipolar disorder, will be included', 'depressed inpatients']","['light-emitting diode (LED) technology', 'dynamic LED-lighting arm and a static LED-lighting', 'Light therapy', 'Dynamic LED-light versus static LED-light']","['17-item Hamilton Depression Rating Scale', 'baseline adjusted score on the 6-item Hamilton Depression Rating Scale', 'Hamilton Depression Rating Scale scores', 'mean score on the Suicidal Ideation Attributes Scale', 'World Health Organisation Quality of Life-BREF (WHOQOL-BREF']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0023700', 'cui_str': 'Illumination'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0031765', 'cui_str': 'Photoradiation Therapy'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0449234', 'cui_str': 'Attribute (attribute)'}, {'cui': 'C0043236', 'cui_str': 'Healths, International'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C0034380'}]",150.0,0.0695436,No ethical issues are expected.,"[{'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Volf', 'Affiliation': 'Psychiatric Centre Copenhagen, University Hospital Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anne Sofie', 'Initials': 'AS', 'LastName': 'Aggestrup', 'Affiliation': 'Psychiatric Centre Copenhagen, University Hospital Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Paul Michael', 'Initials': 'PM', 'LastName': 'Petersen', 'Affiliation': 'Department of Photonics Engineering, Technical University of Denmark, Lyngby, Denmark.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Dam-Hansen', 'Affiliation': 'Department of Photonics Engineering, Technical University of Denmark, Lyngby, Denmark.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Knorr', 'Affiliation': 'Psychiatric Centre Copenhagen, University Hospital Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ema Erkocevic', 'Initials': 'EE', 'LastName': 'Petersen', 'Affiliation': 'The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Janus', 'Initials': 'J', 'LastName': 'Engstrøm', 'Affiliation': 'Centre for Clinical Intervention Research, Rigshospitalet, Kobenhavn, Denmark.'}, {'ForeName': 'Janus C', 'Initials': 'JC', 'LastName': 'Jakobsen', 'Affiliation': 'The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Torben Skov', 'Initials': 'TS', 'LastName': 'Hansen', 'Affiliation': 'Chromaviso, Aarhus, Denmark.'}, {'ForeName': 'Helle Østergaard', 'Initials': 'HØ', 'LastName': 'Madsen', 'Affiliation': 'Psychiatric Centre Copenhagen, University Hospital Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Hageman', 'Affiliation': 'Mental Health Services in the Capital Region of Denmark, Kobenhavn O, Denmark.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Martiny', 'Affiliation': 'Psychiatric Centre Copenhagen, University Hospital Copenhagen, Copenhagen, Denmark klaus.martiny@regionh.dk.'}]",BMJ open,['10.1136/bmjopen-2019-032233']
865,31326480,Randomized Comparison of Clinical Effectiveness of Pharmacologic SPECT and PET MPI in Symptomatic CAD Patients.,"OBJECTIVES


This study compared the clinical effectiveness of pharmacologic stress myocardial perfusion imaging (MPI) plus positron emission tomography (PET) with single-photon emission computed tomography (SPECT) in patients with known coronary artery disease (CAD) presenting with symptoms suggestive of ischemia.
BACKGROUND


Although PET MPI has been shown to have higher diagnostic accuracy in detecting hemodynamically significant CAD than SPECT MPI, whether this impacts downstream management has not been formally evaluated in randomized trials.
METHODS


This study consisted of a single-center trial in which patients with known CAD and suspected ischemia were randomized to undergo PET or attenuation-corrected SPECT MPI between June 2009 and September 2013. Post-test management was at the discretion of the referring physician, and patients were followed for 12 months. The primary endpoint was diagnostic failure, defined as unnecessary angiography (absence of ≥50% stenosis in ≥1 vessel) or additional noninvasive testing within 60 days of the MPI. Secondary endpoints were post-test escalation of antianginal therapy, referral for angiography, coronary revascularization, and health status at 3, 6, and 12 months.
RESULTS


A total of 322 patients with an evaluable MPI were randomized (n = 161 in each group). At baseline, 88.8% of patients were receiving aspirin therapy, 76.7% were taking beta-blockers, and 77.3% were taking statin therapy. Diagnostic failure within 60 days occurred in only 7 patients (2.2%) (3 [1.9%] in the PET group and 4 [2.5%] in the SPECT group; p = 0.70). There were no significant differences between the 2 groups in subsequent rates of coronary angiography, coronary revascularization, or health status at 3, 6, and 12 months of follow-up (all p values ≥0.20); however, when subjects were stratified by findings on MPI in a post hoc analysis, those with high-risk MPI on PET testing had higher rates of angiography and revascularization on follow-up than those who had SPECT MPI, whereas those undergoing low-risk PET studies had lower rates of both procedures than those undergoing SPECT (interaction between randomized modality ∗high-risk MPI for 12-month catheterization [p = 0.001] and 12-month revascularization [p = 0.09]).
CONCLUSIONS


In this contemporary cohort of symptomatic CAD patients who were optimally medically managed, there were no discernible differences in rates of diagnostic failure at 60 days, subsequent coronary angiography, revascularization, or patient health status at 1 year between patients evaluated by pharmacologic PET compared with those evaluated by SPECT MPI. Downstream invasive testing rates with PET MPI were more consistent with high-risk features than those with SPECT MPI. (Effectiveness Study of Single Photon Emission Computed Tomography [SPECT] Versus Positron Emission Tomography [PET] Myocardial Perfusion Imaging; NCT00976053).",2019,"There were no significant differences between the 2 groups in subsequent rates of coronary angiography, coronary revascularization, or health status at 3, 6, and 12 months of follow-up (all p values ≥0.20); however when subjects were stratified by findings on MPI in a post hoc analysis, those with high-risk MPI on PET testing had higher rates of angiography and revascularization on follow-up than those who had SPECT MPI, whereas those undergoing low-risk PET studies had lower rates of both procedures than those undergoing SPECT (interaction between randomized modality ∗high-risk MPI for 12-month catheterization [p = 0.001] and 12-month revascularization [p = 0.09]).
","['Symptomatic CAD Patients', 'patients with known coronary artery disease (CAD) presenting with symptoms suggestive of ischemia', '322 patients with an evaluable MPI', 'patients with known CAD and suspected ischemia']","['aspirin therapy', 'PET or attenuation-corrected SPECT MPI', 'Single Photon Emission Computed Tomography [SPECT', 'pharmacologic stress myocardial perfusion imaging (MPI) plus positron emission tomography (PET) with single-photon emission computed tomography (SPECT', 'Pharmacologic SPECT and PET MPI']","['subsequent rates of coronary angiography, coronary revascularization, or health status', 'rates of angiography and revascularization', 'diagnostic failure, defined as unnecessary angiography (absence of', 'Diagnostic failure', 'rates of diagnostic failure', 'post-test escalation of antianginal therapy, referral for angiography, coronary revascularization, and health status at 3, 6, and 12\xa0months', 'subsequent coronary angiography, revascularization, or patient health status']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332299', 'cui_str': 'Suggestive of (attribute)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C4517712', 'cui_str': 'Three hundred and twenty-two'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}]","[{'cui': 'C4303556', 'cui_str': 'Aspirin therapy'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0040399', 'cui_str': 'SPECT'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C2350390', 'cui_str': 'Myocardial Perfusion Imaging'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}]","[{'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0585942', 'cui_str': 'Antianginal therapy (procedure)'}, {'cui': 'C2585524', 'cui_str': 'Referral for'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",322.0,0.14538,"There were no significant differences between the 2 groups in subsequent rates of coronary angiography, coronary revascularization, or health status at 3, 6, and 12 months of follow-up (all p values ≥0.20); however when subjects were stratified by findings on MPI in a post hoc analysis, those with high-risk MPI on PET testing had higher rates of angiography and revascularization on follow-up than those who had SPECT MPI, whereas those undergoing low-risk PET studies had lower rates of both procedures than those undergoing SPECT (interaction between randomized modality ∗high-risk MPI for 12-month catheterization [p = 0.001] and 12-month revascularization [p = 0.09]).
","[{'ForeName': 'Krishna K', 'Initials': 'KK', 'LastName': 'Patel', 'Affiliation': ""Department of Cardiology, University of Missouri-Kansas City, Kansas City, Missouri; Department of Cardiology, Saint Luke's Mid America Heart Institute, Kansas City, Missouri. Electronic address: patelkris@umkc.edu.""}, {'ForeName': 'Firas', 'Initials': 'F', 'LastName': 'Al Badarin', 'Affiliation': ""Department of Cardiology, University of Missouri-Kansas City, Kansas City, Missouri; Department of Cardiology, Saint Luke's Mid America Heart Institute, Kansas City, Missouri.""}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Chan', 'Affiliation': ""Department of Cardiology, University of Missouri-Kansas City, Kansas City, Missouri; Department of Cardiology, Saint Luke's Mid America Heart Institute, Kansas City, Missouri.""}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': ""Department of Cardiology, University of Missouri-Kansas City, Kansas City, Missouri; Department of Cardiology, Saint Luke's Mid America Heart Institute, Kansas City, Missouri.""}, {'ForeName': 'Staci', 'Initials': 'S', 'LastName': 'Courter', 'Affiliation': 'Cardiovascular Imaging Technologies, Kansas City, Missouri.'}, {'ForeName': 'Kevin F', 'Initials': 'KF', 'LastName': 'Kennedy', 'Affiliation': ""Department of Cardiology, Saint Luke's Mid America Heart Institute, Kansas City, Missouri.""}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Case', 'Affiliation': 'Cardiovascular Imaging Technologies, Kansas City, Missouri.'}, {'ForeName': 'A Iain', 'Initials': 'AI', 'LastName': 'McGhie', 'Affiliation': ""Department of Cardiology, University of Missouri-Kansas City, Kansas City, Missouri; Department of Cardiology, Saint Luke's Mid America Heart Institute, Kansas City, Missouri.""}, {'ForeName': 'Gary V', 'Initials': 'GV', 'LastName': 'Heller', 'Affiliation': 'Department of Cardiology, Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey.'}, {'ForeName': 'Timothy M', 'Initials': 'TM', 'LastName': 'Bateman', 'Affiliation': ""Department of Cardiology, University of Missouri-Kansas City, Kansas City, Missouri; Department of Cardiology, Saint Luke's Mid America Heart Institute, Kansas City, Missouri.""}]",JACC. Cardiovascular imaging,['10.1016/j.jcmg.2019.04.020']
866,32070556,The impact of lag screw in the healing time of distal tibia fractures treated with minimally invasive plate osteosynthesis: A randomized clinical trial.,"BACKGROUND


In recent years, Minimally Invasive Plate Osteosynthesis (MIPO) has been gaining popularity in the treatment of distal tibia fractures, because it is a minimally invasive surgical procedure, thus it limits the soft-tissues damage. This prospective randomized study aims to assess the impact of lag screw in the healing time of distal tibia fractures treated with MIPO technique, in a six-month follow-up.
METHODS


Patients between 20 and 70 years of age with distal tibial fracture, type 43-A according to AO/OTA classification system. All the patients were randomized into two groups, to receive MIPO without lag screw (Group-A) or MIPO with percutaneous lag screw (Group-B). Patients were followed clinically and radiographically at 3, 6, 12 and 24 weeks postoperatively. The main outcome measure was the time needed to achieve the painless full weight-bearing (FWB) after surgery. Unpaired t-test after ANOVA (analysis of variance) was performed to assess AOFAS score differences between the 2 groups at each follow-up. Pearson correlation test also was performed. The tests were two-tailed with a confidence level of 5%.
RESULTS


42 patients (24 male and 18 female, mean age 49.54 years old, range 25-80) were recruited. A significant shorter mean time until painless FWB (p = 0.016) was observed in Group-B (11.22 ± 3.06 weeks) compared with Group-A (13.48 ± 2.42 weeks) (Table 2). The mean AOFAS score was comparable in patients treated with (Group-B) and without lag screw (Group-A) at all follow-ups.
CONCLUSIONS


This prospective randomized clinical study has shown that the use of lag screw in distal tibia fractures treated with MIPO technique speeds the fracture healing, thus shortening the time needed to achieve FWB.",2020,A significant shorter mean time until painless FWB (p = 0.016) was observed in Group-B (11.22 ± 3.06 weeks) compared with Group-A (13.48 ± 2.42 weeks),"['distal tibia fractures treated with minimally invasive plate osteosynthesis', 'Patients between 20 and 70 years of age with distal tibial fracture, type 43-A according to AO/OTA classification system', '42 patients (24 male and 18 female, mean age 49.54 years old, range 25-80) were recruited']","['MIPO without lag screw (Group-A) or MIPO with percutaneous lag screw', 'MIPO technique', 'lag screw', 'Minimally Invasive Plate Osteosynthesis (MIPO']","['AOFAS score differences', 'time needed to achieve the painless full weight-bearing (FWB', 'mean time until painless FWB', 'mean AOFAS score']","[{'cui': 'C0588200', 'cui_str': 'Bone structure of distal tibia (body structure)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0040185', 'cui_str': 'Tibial Fractures'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0234226', 'cui_str': 'Painless (qualifier value)'}, {'cui': 'C0085086', 'cui_str': 'Finding of weight-bearing'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",80.0,0.0428134,A significant shorter mean time until painless FWB (p = 0.016) was observed in Group-B (11.22 ± 3.06 weeks) compared with Group-A (13.48 ± 2.42 weeks),"[{'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Vicenti', 'Affiliation': 'Orthopedic & Trauma Unit, Department of Basic Medical Sciences, Neuroscience and Sense Organs, School of Medicine, University of Bari ""Aldo Moro"" - AOU Consorziale ""Policlinico"", Piazza Giulio Cesare 11, 70100 Bari, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Bizzoca', 'Affiliation': 'Orthopedic & Trauma Unit, Department of Basic Medical Sciences, Neuroscience and Sense Organs, School of Medicine, University of Bari ""Aldo Moro"" - AOU Consorziale ""Policlinico"", Piazza Giulio Cesare 11, 70100 Bari, Italy.'}, {'ForeName': 'Vittorio Saverio', 'Initials': 'VS', 'LastName': 'Nappi', 'Affiliation': 'Orthopedic & Trauma Unit, Department of Basic Medical Sciences, Neuroscience and Sense Organs, School of Medicine, University of Bari ""Aldo Moro"" - AOU Consorziale ""Policlinico"", Piazza Giulio Cesare 11, 70100 Bari, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Carrozzo', 'Affiliation': 'Orthopedic & Trauma Unit, Department of Basic Medical Sciences, Neuroscience and Sense Organs, School of Medicine, University of Bari ""Aldo Moro"" - AOU Consorziale ""Policlinico"", Piazza Giulio Cesare 11, 70100 Bari, Italy. Electronic address: doc.mcarrozzo@gmail.com.'}, {'ForeName': 'Michelangelo', 'Initials': 'M', 'LastName': 'Delmedico', 'Affiliation': 'Orthopedic & Trauma Unit, Department of Basic Medical Sciences, Neuroscience and Sense Organs, School of Medicine, University of Bari ""Aldo Moro"" - AOU Consorziale ""Policlinico"", Piazza Giulio Cesare 11, 70100 Bari, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Solarino', 'Affiliation': 'Orthopedic & Trauma Unit, Department of Basic Medical Sciences, Neuroscience and Sense Organs, School of Medicine, University of Bari ""Aldo Moro"" - AOU Consorziale ""Policlinico"", Piazza Giulio Cesare 11, 70100 Bari, Italy.'}, {'ForeName': 'Biagio', 'Initials': 'B', 'LastName': 'Moretti', 'Affiliation': 'Orthopedic & Trauma Unit, Department of Basic Medical Sciences, Neuroscience and Sense Organs, School of Medicine, University of Bari ""Aldo Moro"" - AOU Consorziale ""Policlinico"", Piazza Giulio Cesare 11, 70100 Bari, Italy.'}]",Injury,['10.1016/j.injury.2020.02.042']
867,31730565,No Benefit of Ingestion of a Ketone Monoester Supplement on 10-km Running Performance.,"PURPOSE


Preexercise ingestion of exogenous ketones alters the metabolic response to exercise, but effects on exercise performance have been equivocal.
METHODS


On two occasions in a double-blind, randomized crossover design, eight endurance-trained runners performed 1 h of submaximal exercise at approximately 65% V˙O2max immediately followed by a 10-km self-paced time trial (TT) on a motorized treadmill. An 8% carbohydrate-electrolyte solution was consumed before and during exercise, either alone (CHO + PLA), or with 573 mg·kg of a ketone monoester supplement (CHO + KME). Expired air, HR, and RPE were monitored during submaximal exercise. Serial venous blood samples were assayed for plasma glucose, lactate, and β-hydroxybutyrate concentrations.
RESULTS


CHO + KME produced plasma β-hydroxybutyrate concentrations of approximately 1.0 to 1.3 mM during exercise (P < 0.001), but plasma glucose and lactate concentrations were similar during exercise in both trials. V˙O2, running economy, respiratory exchange ratio, HR, and RPE were also similar between trials. Performance in the 10-km TT was not different (P = 0.483) between CHO + KME (mean, 2402 s; 95% confidence interval, 2204-2600 s) and CHO + PLA (mean, 2422 s; 95% confidence interval, 2217-2628 s). Cognitive performance, measured by reaction time and a multitasking test, did not differ between trials.
CONCLUSIONS


Compared with carbohydrate alone, coingestion of KME by endurance-trained athletes elevated plasma β-hydroxybutyrate concentrations, but did not improve 10-km running TT or cognitive performance.",2019,"Performance in the 10-km TT was not different (P = 0.483) between CHO + KME (mean, 2402 s; 95% confidence interval, 2204-2600 s) and CHO + PLA (mean, 2422 s; 95% confidence interval, 2217-2628 s).",[],"['ketone monoester supplement (CHO + KME', 'eight endurance-trained runners performed 1 h of submaximal exercise at approximately 65% V˙O2max immediately followed by a 10-km self-paced time trial (TT) on a motorized treadmill', 'carbohydrate alone, coingestion of KME', 'Ketone Monoester Supplement', 'carbohydrate-electrolyte solution']","['plasma β-hydroxybutyrate concentrations', 'V˙O2, running economy, respiratory exchange ratio, HR, and RPE', 'plasma glucose and lactate concentrations', 'plasma glucose, lactate, and β-hydroxybutyrate concentrations', 'reaction time and a multitasking test', '10-km Running Performance', 'Expired air, HR, and RPE', 'Cognitive performance', '10-km running TT or cognitive performance']",[],"[{'cui': 'C0022634', 'cui_str': 'Ketones'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C3541941', 'cui_str': 'Electrolyte solutions'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient (observable entity)'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0001861', 'cui_str': 'Air'}]",,0.281832,"Performance in the 10-km TT was not different (P = 0.483) between CHO + KME (mean, 2402 s; 95% confidence interval, 2204-2600 s) and CHO + PLA (mean, 2422 s; 95% confidence interval, 2217-2628 s).","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'School of Health and Human Performance, Dublin City University, Glasnevin, Dublin, IRELAND.'}, {'ForeName': 'Fionn T', 'Initials': 'FT', 'LastName': 'McSwiney', 'Affiliation': 'School of Health Sciences, Waterford Institute of Technology, Waterford, IRELAND.'}, {'ForeName': 'Aidan J', 'Initials': 'AJ', 'LastName': 'Brady', 'Affiliation': 'School of Health and Human Performance, Dublin City University, Glasnevin, Dublin, IRELAND.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Egan', 'Affiliation': 'School of Health and Human Performance, Dublin City University, Glasnevin, Dublin, IRELAND.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002065']
868,32168168,HIV Oral Self-Testing for Male Partners of Women Attending Antenatal Care in Central Uganda: Uptake of Testing and Linkage to Care in a Randomized Trial.,"BACKGROUND


In Uganda, HIV testing rates are approximately 90% among women in antenatal care, with male rates much lower. The World Health Organization has recommended HIV self-testing (HIVST), and one promising model is for women in antenatal care to deliver HIVST kits to their male partners. We investigated the impact of this model on male partner testing rates.
SETTING


Three high-volume antenatal clinics in central Uganda.
METHODS


We implemented a cluster-randomized controlled trial comparing standard of care to intervention, with the primary outcome of self-reported male partner HIV testing. Women and male partners were followed at 1 and 3 months. We used unadjusted analyses and log-linear models with an intent-to-treat approach accounting for clustering.
RESULTS


Study coordinators randomized 1514 women (777 intervention and 737 control). Baseline characteristics were balanced across arms with mean age (SD) of 25.2 (5.5) years and >44% with secondary education or higher. More male partners tested for HIV in intervention [576/746 (77.2%)] versus control [264/709 (37.2%)], P < 0.01. We identified 34 HIV-positive men in intervention versus 10 in control, with 6/26 (23%) and 4/6 (67%), respectively, reporting linking to care.
CONCLUSIONS


Our results demonstrate an enormous increase in self-reported partner HIV testing when HIVST is available at home. However, men testing positive through HIVST appeared less likely to link to care than men testing positive at a clinic. These results highlight the potential of HIVST in increasing HIV testing rates, while underscoring the importance of developing effective approaches to maximizing linkage to care among those testing positive through HIVST.",2020,"More male partners tested for HIV in intervention [576/746 (77.2%)] versus control [264/709 (37.2%)], p<0.01.","['34 HIV positive men in intervention versus 10 in control, with 6/26 (23%) and 4/6 (67%), respectively, reporting linking to care', 'Women and male partners', '1,514 women (777 intervention, 737 control', 'male partners of women attending antenatal care in central Uganda', 'Three high-volume antenatal clinics in central Uganda', 'male partner testing rates']","['HIV oral self-testing', 'HIVST']",[],"[{'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",[],1514.0,0.147164,"More male partners tested for HIV in intervention [576/746 (77.2%)] versus control [264/709 (37.2%)], p<0.01.","[{'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Korte', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Kisa', 'Affiliation': 'Department of Disease Control and Environmental Health, Makerere University School of Public Health, Kampala, Uganda.'}, {'ForeName': 'Caroline J', 'Initials': 'CJ', 'LastName': 'Vrana-Diaz', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Malek', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Buregyeya', 'Affiliation': 'Department of Disease Control and Environmental Health, Makerere University School of Public Health, Kampala, Uganda.'}, {'ForeName': 'Joseph K B', 'Initials': 'JKB', 'LastName': 'Matovu', 'Affiliation': 'Department of Disease Control and Environmental Health, Makerere University School of Public Health, Kampala, Uganda.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Kagaayi', 'Affiliation': 'Rakai Health Sciences Program, Kalisizo, Uganda.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Musoke', 'Affiliation': 'Clinical Services, Mildmay Uganda, Kampala, Uganda.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Chemusto', 'Affiliation': 'Research and Strategic Information, Mildmay Uganda, Kampala, Uganda.'}, {'ForeName': 'Semei C', 'Initials': 'SC', 'LastName': 'Mukama', 'Affiliation': 'Research and Strategic Information, Mildmay Uganda, Kampala, Uganda.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Ndyanabo', 'Affiliation': 'Rakai Health Sciences Program, Kalisizo, Uganda.'}, {'ForeName': 'Shaban', 'Initials': 'S', 'LastName': 'Mugerwa', 'Affiliation': 'AIDS Control Program, Ministry of Health, Kampala, Uganda.'}, {'ForeName': 'Rhoda K', 'Initials': 'RK', 'LastName': 'Wanyenze', 'Affiliation': 'Department of Disease Control and Environmental Health, Makerere University School of Public Health, Kampala, Uganda.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002341']
869,31973579,Oxidative Stress Biomarker Decreased in Preterm Neonates Treated With Kangaroo Mother Care.,"OBJECTIVE


Due to physiological and metabolic immaturity, prematurely born infants are at increased risk because of maternal separation in many neonatal intensive care units (NICUs). The stress induced from maternal-infant separation can lead to well-documented short-term physiologic instability and potentially lifelong neurological, sociological, or psychological sequelae. Based on previous studies of kangaroo mother care (KMC) that demonstrated improvement in physiologic parameters, we examined the impact of KMC on physiologic measures of stress (abdominal temperature, heart rate, oxygen saturation, perfusion index, near-infrared spectrometry), oxidative stress, and energy utilization/conservation in preterm infants.
METHODS


In this randomized, stratified study of premature neonates, we compared the effects on urinary concentrations of biomarkers of energy utilization and oxidative stress of 1 hr of KMC versus incubator care on Day 3 of life in intervention-group babies ( n  = 26) and control-group babies ( n  = 25), respectively. On Day 4, both groups received 1 hr of KMC. Urinary samples were collected 3 hr before and 3 hr after intervention/incubator care on both days. Energy utilization was assessed by measures of adenosine triphosphate (ATP) degradation (i.e., hypoxanthine, xanthine, and uric acid). Oxidative stress was assessed using urinary allantoin. Mixed-models analysis was used to assess differences in purine/allantoin.
RESULTS


Mean allantoin levels over Days 3 and 4 were significantly lower in the KMC group than in the control group ( p  = .026).
CONCLUSIONS


Results provide preliminary evidence that KMC reduces neonatal oxidative stress processes and that urinary allantoin could serve as an effective noninvasive marker for future studies.",2020,"Mean allantoin levels over Days 3 and 4 were significantly lower in the KMC group than in the control group ( p  = .026).
","['Preterm Neonates', 'premature neonates', 'intervention-group babies ( n  = 26) and control-group babies ( n  = 25), respectively', 'preterm infants']","['kangaroo mother care (KMC', 'KMC versus incubator care', 'KMC']","['Oxidative stress', 'adenosine triphosphate (ATP) degradation (i.e., hypoxanthine, xanthine, and uric acid', 'Energy utilization', 'Oxidative Stress Biomarker', 'physiologic measures of stress (abdominal temperature, heart rate, oxygen saturation, perfusion index, near-infrared spectrometry), oxidative stress, and energy utilization/conservation', 'Mean allantoin levels']","[{'cui': 'C0205252', 'cui_str': 'Immature (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C1257803', 'cui_str': 'Kangaroo-Mother Care'}, {'cui': 'C0021178', 'cui_str': 'Incubators'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0001480', 'cui_str': 'ATP'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0020684', 'cui_str': 'Hypoxanthine'}, {'cui': 'C3541955', 'cui_str': 'Xanthines'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0376519', 'cui_str': 'Spectrometry, Near-Infrared'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0002083', 'cui_str': 'Allantoin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0497913,"Mean allantoin levels over Days 3 and 4 were significantly lower in the KMC group than in the control group ( p  = .026).
","[{'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Forde', 'Affiliation': 'Hahn School of Nursing, University of San Diego, CA, USA.'}, {'ForeName': 'Douglas D', 'Initials': 'DD', 'LastName': 'Deming', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, School of Medicine, Loma Linda University, Loma, CA, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Tan', 'Affiliation': 'Department of Basic Sciences, Division of Biomedical Engineering Sciences, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Raylene M', 'Initials': 'RM', 'LastName': 'Phillips', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, School of Medicine, Loma Linda University, Loma, CA, USA.'}, {'ForeName': 'Eileen K', 'Initials': 'EK', 'LastName': 'Fry-Bowers', 'Affiliation': 'Hahn School of Nursing, University of San Diego, CA, USA.'}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Barger', 'Affiliation': 'Hahn School of Nursing, University of San Diego, CA, USA.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Bahjri', 'Affiliation': 'School of Pharmacy, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Danilyn M', 'Initials': 'DM', 'LastName': 'Angeles', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, School of Medicine, Loma Linda University, Loma, CA, USA.'}, {'ForeName': 'Danilo S', 'Initials': 'DS', 'LastName': 'Boskovic', 'Affiliation': 'Department of Basic Sciences, Division of Biochemistry, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}]",Biological research for nursing,['10.1177/1099800419900231']
870,32167131,Prospective clinical trial examining the impact of genetic variation in FADS1 on the metabolism of linoleic acid- and ɣ-linolenic acid-containing botanical oils.,"BACKGROUND


Unexplained heterogeneity in clinical trials has resulted in questions regarding the effectiveness of ɣ-linolenic acid (GLA)-containing botanical oil supplements. This heterogeneity may be explained by genetic variation within the fatty acid desaturase (FADS) gene cluster that is associated with circulating and tissue concentrations of arachidonic acid (ARA) and dihomo-ɣ-linolenic acid (DGLA), both of which may be synthesized from GLA and result in proinflammatory and anti-inflammatory metabolites, respectively.
OBJECTIVES


The objective of this study was to prospectively compare the capacity of a non-Hispanic white cohort, stratified by FADS genotype at the key single-nucleotide polymorphism (SNP) rs174537, to metabolize 18-carbon omega-6 (n-6) PUFAs in borage oil (BO) and soybean oil (SO) to GLA, DGLA, and ARA.
METHODS


Healthy adults (n = 64) participated in a randomized, double-blind, crossover intervention. Individuals received encapsulated BO (Borago officinalis L.; 37% LA and 23% GLA) or SO [Glycine max (L.) Merr.; 50% LA and 0% GLA] for 4 wk, followed by an 8-wk washout period, before consuming the opposite oil for 4 wk. Serum lipids and markers of inflammation (C-reactive protein) were assessed for both oil types at baseline and during weeks 2 and 4 of the intervention.
RESULTS


SO supplementation failed to alter circulating concentrations of any n-6 long-chain PUFAs. In contrast, a modest daily dose of BO elevated serum concentrations of GLA and DGLA in an rs174537 genotype-dependent manner. In particular, DGLA increased by 57% (95% CI: 0.38, 0.79) in GG genotype individuals, but by 141% (95% CI: 1.03, 2.85) in TT individuals. For ARA, baseline concentrations varied substantially by genotype and increased modestly with BO supplementation, suggesting a key role for FADS variation in the balance of DGLA and ARA.
CONCLUSIONS


The results of this study clearly suggest that personalized and population-based approaches considering FADS genetic variation may be necessary to optimize the design of future clinical studies with GLA-containing oils. This trial was registered at clinicaltrials.gov as NCT02337231.",2020,"In particular, DGLA increased by 57% (95% CI: 0.38, 0.79) in GG genotype individuals, but by 141% (95% CI: 1.03, 2.85) in TT individuals.",['Healthy adults (n\xa0=\xa064'],"['metabolize 18-carbon omega-6', 'n-6) PUFAs in borage oil (BO) and soybean oil (SO', 'acid- and ɣ-linolenic acid-containing botanical oils', 'linoleic', 'linolenic acid (GLA)-containing botanical oil supplements', 'encapsulated BO (Borago officinalis L.; 37% LA and 23% GLA) or SO [Glycine max (L']","['DGLA', 'Serum lipids and markers of inflammation (C-reactive protein']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0007009', 'cui_str': 'Carbon-12'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0212750', 'cui_str': 'starflower oil'}, {'cui': 'C0037732', 'cui_str': 'Soybean Oil'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0125903', 'cui_str': 'Linolenic Acid'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0205223', 'cui_str': 'Encapsulated (qualifier value)'}, {'cui': 'C0522464', 'cui_str': 'Borage'}, {'cui': 'C0037733', 'cui_str': 'Soy Beans'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]",64.0,0.454568,"In particular, DGLA increased by 57% (95% CI: 0.38, 0.79) in GG genotype individuals, but by 141% (95% CI: 1.03, 2.85) in TT individuals.","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Sergeant', 'Affiliation': 'Department of Biochemistry, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hallmark', 'Affiliation': 'BIO5 Institute, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Rasika A', 'Initials': 'RA', 'LastName': 'Mathias', 'Affiliation': 'Center for Botanical Lipids and Inflammatory Disease Prevention, Wake Forest School of Medicine,Winston-Salem, NC, USA.'}, {'ForeName': 'Tammy L', 'Initials': 'TL', 'LastName': 'Mustin', 'Affiliation': 'Center for Botanical Lipids and Inflammatory Disease Prevention, Wake Forest School of Medicine,Winston-Salem, NC, USA.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Ivester', 'Affiliation': 'Center for Botanical Lipids and Inflammatory Disease Prevention, Wake Forest School of Medicine,Winston-Salem, NC, USA.'}, {'ForeName': 'Maggie L', 'Initials': 'ML', 'LastName': 'Bohannon', 'Affiliation': 'Center for Botanical Lipids and Inflammatory Disease Prevention, Wake Forest School of Medicine,Winston-Salem, NC, USA.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Ruczinski', 'Affiliation': 'Center for Botanical Lipids and Inflammatory Disease Prevention, Wake Forest School of Medicine,Winston-Salem, NC, USA.'}, {'ForeName': 'Laurel', 'Initials': 'L', 'LastName': 'Johnstone', 'Affiliation': 'BIO5 Institute, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Seeds', 'Affiliation': 'Center for Botanical Lipids and Inflammatory Disease Prevention, Wake Forest School of Medicine,Winston-Salem, NC, USA.'}, {'ForeName': 'Floyd H', 'Initials': 'FH', 'LastName': 'Chilton', 'Affiliation': 'Center for Botanical Lipids and Inflammatory Disease Prevention, Wake Forest School of Medicine,Winston-Salem, NC, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa023']
871,32167226,Custom and prefabricated PolyEtherKetoneKetone (PEKK) post-core systems bond strength: Scanning electron microscopy evaluation.,"The present study evaluated the bond strengths of prefabricated PolyEtherKetoneKetone (PEKK) posts, PEKK posts custom-configured according to root-canal size, and conventional fiber posts. A total of 30 maxillary incisors were randomly divided into three groups, as follows: Group 1: fiber posts; Group 2: prefabricated PEKK posts; Group 3; custom-made PEKK posts. Following endodontic treatment, post spaces were prepared, and posts were cemented with resin cement. Push-out bond strength testing was performed using a universal testing machine, and fractures modes were examined under a scanning electron microscope. Data were analyzed using One-way ANOVA and Tukey's HSD tests, with the level of significance set at .05. The highest bond-strength values in the cervical section were observed with the custom-made PEKK post (17.3470 MPa), whereas the highest bond-strength values in the middle and apical sections were observed with the conventional fiber posts (11.5375 MPa and 6.8625 MPa, respectively). Bond-strength values for all posts systems decreased in a cervical to apical direction. PEKK posts are a suitable alternative to fiber posts. Although custom-made PEKK posts demonstrated better bond strength than prefabricated PEKK posts, further studies are needed to evaluate their clinical performance.",2020,"Although custom-made PEKK posts demonstrated better bond strength than prefabricated PEKK posts, further studies are needed to evaluate their clinical performance.",['A total of 30 maxillary incisors'],['fiber posts; Group 2: prefabricated PEKK posts; Group 3; custom-made PEKK posts'],"['highest bond-strength values', 'bond strength']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0021156', 'cui_str': 'Incisor'}]","[{'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0162343', 'cui_str': 'Customs'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",30.0,0.0131857,"Although custom-made PEKK posts demonstrated better bond strength than prefabricated PEKK posts, further studies are needed to evaluate their clinical performance.","[{'ForeName': 'Melahat Çelik', 'Initials': 'MÇ', 'LastName': 'Güven', 'Affiliation': 'Department of Prosthodontics, Faculty of Dentistry, Istanbul Yeni Yüzyıl University, Istanbul, Turkey.'}, {'ForeName': 'Süleyman Çağatay', 'Initials': 'SÇ', 'LastName': 'Dayan', 'Affiliation': 'Program of Dental Technicians, Istanbul University-Cerrahpasa, Istanbul, Turkey.'}, {'ForeName': 'Gülhan', 'Initials': 'G', 'LastName': 'Yıldırım', 'Affiliation': 'Department of Prosthodontics, Faculty of Dentistry, Istanbul Yeni Yüzyıl University, Istanbul, Turkey.'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Mumcu', 'Affiliation': 'Department of Prosthodontics. Faculty of Dentistry, Eskisehir Osmangazi University, Odunpazarı, Turkey.'}]",Microscopy research and technique,['10.1002/jemt.23471']
872,31964678,FACT: a randomised controlled trial to assess the feasibility of QbTest in the assessment process of attention deficit hyperactivity disorder (ADHD) for young people in prison-a feasibility trial protocol.,"INTRODUCTION


The prevalence of attention deficit hyperactivity disorder (ADHD) within the Children and Young People Secure Estate (CYPSE) is much higher than seen in the general population. To make a diagnosis of ADHD, clinicians draw on information from multiple sources, including parents and teachers. However, obtaining these is particularly difficult for young people in the secure estate. There is increasing evidence in the community that QbTest is able to assist in the accurate and earlier diagnosis of ADHD. The objective of this study is to assess the feasibility and acceptability of QbTest in the assessment of ADHD within the CYPSE.
METHODS AND ANALYSIS


A single-centre parallel group feasibility randomised controlled trial will be conducted. Sixty young people within the CYPSE identified as displaying possible symptoms of ADHD will be randomised to the intervention arm (n=30; QbTest plus usual care) or control arm (n=30; usual care). Primary analyses will be descriptive and a process evaluation will be conducted to assess the contexts involved in implementing the intervention. Interviews will be conducted to explore acceptability and thematic analysis will be used to analyse the data.
ETHICS AND DISSEMINATION


This study was approved by National Health Service Wales research ethics committee 3 (18/WA/0347) on 15 February 2019. The findings will be published in peer-reviewed journals, presented at relevant conferences and disseminated to the public via summaries cocreated with our patient and public involvement group.
TRIAL REGISTRATION NUMBER


ISRCTN17402196.",2020,There is increasing evidence in the community that QbTest is able to assist in the accurate and earlier diagnosis of ADHD.,['Sixty young people within the CYPSE identified as displaying possible symptoms of ADHD'],['FACT'],[],"[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}]",[],[],60.0,0.166984,There is increasing evidence in the community that QbTest is able to assist in the accurate and earlier diagnosis of ADHD.,"[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Lennox', 'Affiliation': 'Division of Psychology and Mental Health, The University of Manchester, Manchester, UK charlotte.lennox@manchester.ac.uk.'}, {'ForeName': 'Charlotte Lucy', 'Initials': 'CL', 'LastName': 'Hall', 'Affiliation': 'Division of Psychiatry & Applied Psychology, Institute of Mental Health, University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Lesley-Anne', 'Initials': 'LA', 'LastName': 'Carter', 'Affiliation': 'Centre for Biostatistics, Division of Population Health, Health Services Research and Primary Care, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Beresford', 'Affiliation': 'Social Policy Research Unit, University of York, York, North Yorkshire, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Young', 'Affiliation': 'Department of Clinical and Forensic Psychology, Psychology Services Limited, London, UK.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Kraam', 'Affiliation': 'Child and Adolescent Mental Health Service, Rotherham Doncaster and South Humber Mental Health NHS Foundation Trust, Doncaster, UK.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Brown', 'Affiliation': 'Division of Psychiatry & Applied Psychology, Institute of Mental Health, University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Lloyd', 'Initials': 'L', 'LastName': 'Wilkinson-Cunningham', 'Affiliation': 'Research and Development, Leeds Community Healthcare NHS Trust, Leeds, UK.'}, {'ForeName': 'Mindy', 'Initials': 'M', 'LastName': 'Reeves', 'Affiliation': 'Medical School, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Prathiba', 'Initials': 'P', 'LastName': 'Chitsabesan', 'Affiliation': 'Child and Adolescent Mental Health Service, Pennine Care NHS Foundation Trust, Ashton-under-Lyne, Lancashire, UK.'}]",BMJ open,['10.1136/bmjopen-2019-035519']
873,31154425,Clinical determinants of plasma cardiac biomarkers in patients with stable chest pain.,"OBJECTIVE


Troponin and B-type natriuretic peptide (BNP) concentrations are associated with cardiovascular risk in stable patients. Understanding their determinants and identifying modifiable clinical targets may improve outcomes. We aimed to establish clinical and cardiac determinants of these biomarkers.
METHODS


This was a prespecified substudy from the randomised Scottish Computed Tomography of the Heart trial, which enrolled patients 18-75 years with suspected stable angina between 2010 and 2014 (NCT01149590). We included patients from six centres in whom high-sensitivity troponin I and BNP were measured (Singulex Erenna). Patients with troponin >99th centile upper reference limit (10.2 ng/L) or BNP ≥400 ng/L were excluded to avoid inclusion of patients with myocardial injury or heart failure. Multivariable linear regression models were constructed with troponin and BNP as dependent variables.
RESULTS


In total, 885 patients were included; 881 (99%) and 847 (96%) had troponin and BNP concentrations above the limit of detection, respectively. Participants had a slight male preponderance (n=513; 56.1%), and the median age was 59.0 (IQR 51.0-65.0) years. The median troponin and BNP concentrations were 1.4 (IQR 0.90-2.1) ng/L and 29.1 (IQR 14.0-54.0) ng/L, respectively. Age and atherosclerotic burden were independent predictors of both biomarkers. Male sex, left ventricular mass and systolic blood pressure were independent predictors of increased troponin. In contrast, female sex and left ventricular volume were independent predictors of increased BNP.
CONCLUSIONS


Troponin and BNP are associated with coronary atherosclerosis but have important sex differences and distinct and contrasting associations with CT-determined left ventricular mass and volume.
CLINICAL TRIAL REGISTRATION


NCT01149590; Post-results.",2019,"Male sex, left ventricular mass and systolic blood pressure were independent predictors of increased troponin.","['885 patients were included; 881 (99%) and 847 (96%) had troponin and BNP concentrations above the limit of detection, respectively', 'Patients with troponin >99th centile upper reference limit (10.2\u2009ng/L) or BNP ≥400\u2009ng/L were excluded to avoid inclusion of patients with myocardial injury or heart failure', 'stable patients', 'Participants had a slight male preponderance (n=513; 56.1%), and the median age was 59.0 (IQR 51.0-65.0) years', 'patients from six centres in whom high-sensitivity troponin I and BNP were measured (Singulex Erenna', 'patients with stable chest pain', 'enrolled patients 18-75 years with suspected stable angina between 2010 and 2014 (NCT01149590']",[],"['median troponin and BNP concentrations', 'Male sex, left ventricular mass and systolic blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0523952', 'cui_str': 'Troponin measurement'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C2718050', 'cui_str': 'Limit of Detection'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0439297', 'cui_str': 'pg/mL'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C2937276', 'cui_str': 'Slight (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0920210', 'cui_str': 'Troponin I measurement (procedure)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0340288', 'cui_str': 'Angina Pectoris, Stable'}]",[],"[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0523952', 'cui_str': 'Troponin measurement'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass (finding)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",885.0,0.138541,"Male sex, left ventricular mass and systolic blood pressure were independent predictors of increased troponin.","[{'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Bing', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Henderson', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Hunter', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'Williams', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Alastair J', 'Initials': 'AJ', 'LastName': 'Moss', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Anoop S V', 'Initials': 'ASV', 'LastName': 'Shah', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'McAllister', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Dweck', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Mills', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Adamson', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}]",Heart (British Cardiac Society),['10.1136/heartjnl-2019-314892']
874,31230007,Open-label dose-extending placebos for opioid use disorder: a protocol for a randomised controlled clinical trial with methadone treatment.,"INTRODUCTION


More than 2 million individuals in the USA have an opioid use disorder (OUD). Methadone maintenance treatment is the gold standard of medication-based treatment for OUD, but high-dose methadone is associated with cardiotoxicity and respiratory complications, among other side effects. These adverse effects make enhancing the effectiveness of lower doses of methadone an attractive therapeutic goal. Long recognised for its capacity to enhance treatment outcomes for a wide range of neuropsychiatric disorders including pain, the placebo effect offers an as-yet untested avenue to such an enhancement. This approach is particularly compelling given that individuals with substance use disorder tend to have higher salience attribution and may thereby be more sensitive to placebo effects. Our study combines two promising clinical methodologies-conditioning/dose-extension and open-label placebo-to investigate whether placebo effects can increase the effective potency of methadone in treatment-seeking OUD patients.
METHODS AND ANALYSIS


A total of 120 newly enrolled treatment-seeking OUD patients will be randomly assigned to one of two different groups: either methadone plus daily placebo dose-extension (PDE; treatment group) or methadone/treatment as usual (control). Participants will meet with study team members five times over the course of 3 months of treatment with methadone (baseline, 2 weeks, and 1, 2 and 3 months postbaseline). Throughout this study time period, methadone dosages will be adjusted by an addiction clinician blind to patient assignment, per standard clinical methods. The primary outcome is methadone dose at 3 months. Secondary outcomes include self-report of drug use; 3-month urine toxicology screen results; and treatment retention. Exploratory outcomes include several environmental as well as personality factors associated with OUD and with propensity to demonstrate a placebo effect.
ETHICS AND DISSEMINATION


Human subjects oversight for this study is provided by the University of Maryland, Baltimore and University of Maryland, College Park Institutional Review Boards. Additionally, the study protocol is reviewed annually by an independent Data and Safety Monitoring Board. Study results will be disseminated via research conference presentations and peer-reviewed publications.
TRIAL REGISTRATION NUMBER


NCT02941809.",2019,"Long recognised for its capacity to enhance treatment outcomes for a wide range of neuropsychiatric disorders including pain, the placebo effect offers an as-yet untested avenue to such an enhancement.","['Human subjects oversight for this study is provided by the University of Maryland, Baltimore and University of Maryland, College Park Institutional Review Boards', 'A total of 120 newly enrolled treatment-seeking OUD patients', 'individuals with substance use disorder']","['Methadone maintenance', 'placebo', 'Open-label dose-extending placebos', 'methadone', 'methadone plus daily placebo dose-extension (PDE; treatment group) or methadone/treatment as usual (control']","['several environmental as well as personality factors associated with OUD and with propensity to demonstrate a placebo effect', 'self-report of drug use; 3-month urine toxicology screen results; and treatment retention', 'effective potency of methadone']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0562547', 'cui_str': 'Park (environment)'}, {'cui': 'C0086911', 'cui_str': 'Institutional Review Boards'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0057968', 'cui_str': 'phosphate diethylstilbesterol'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0031208', 'cui_str': 'Personality'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0032041', 'cui_str': 'Placebo Effect'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C0040541', 'cui_str': 'Toxicology'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}]",120.0,0.499642,"Long recognised for its capacity to enhance treatment outcomes for a wide range of neuropsychiatric disorders including pain, the placebo effect offers an as-yet untested avenue to such an enhancement.","[{'ForeName': 'Annabelle M', 'Initials': 'AM', 'LastName': 'Belcher', 'Affiliation': 'Department of Psychiatry, Division of Addiction Research and Treatment, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Thomas O', 'Initials': 'TO', 'LastName': 'Cole', 'Affiliation': 'Department of Psychiatry, Division of Addiction Research and Treatment, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Aaron D', 'Initials': 'AD', 'LastName': 'Greenblatt', 'Affiliation': 'Department of Psychiatry, Division of Addiction Research and Treatment, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Hoag', 'Affiliation': 'Department of Pharmaceutical Sciences, University of Maryland School of Pharmacy, Baltimore, Maryland, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Epstein', 'Affiliation': 'Real-world Assessment, Prediction and Treatment Unit, National Institute on Drug Abuse Intramural Research Program, Baltimore, Maryland, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wagner', 'Affiliation': 'University of Maryland Center for Substance Abuse Research, College Park, Maryland, USA.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Billing', 'Affiliation': 'University of Maryland Center for Substance Abuse Research, College Park, Maryland, USA.'}, {'ForeName': 'Ebonie', 'Initials': 'E', 'LastName': 'Massey', 'Affiliation': 'University of Maryland Center for Substance Abuse Research, College Park, Maryland, USA.'}, {'ForeName': 'Kristen R', 'Initials': 'KR', 'LastName': 'Hamilton', 'Affiliation': 'Department of Psychology, University of Maryland, College Park, Maryland, USA.'}, {'ForeName': 'Zofia K', 'Initials': 'ZK', 'LastName': 'Kozak', 'Affiliation': 'Medical School Training Program, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Welsh', 'Affiliation': 'Department of Psychiatry, Division of Addiction Research and Treatment, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Weintraub', 'Affiliation': 'Department of Psychiatry, Division of Addiction Research and Treatment, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Emerson M', 'Initials': 'EM', 'LastName': 'Wickwire', 'Affiliation': 'Department of Psychiatry, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Wish', 'Affiliation': 'University of Maryland Center for Substance Abuse Research, College Park, Maryland, USA.'}, {'ForeName': 'Ted J', 'Initials': 'TJ', 'LastName': 'Kaptchuk', 'Affiliation': 'Program in Placebo Studies, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Colloca', 'Affiliation': 'Department of Pain and Translational Symptom Science, University of Maryland School of Nursing, Baltimore, Maryland, USA.'}]",BMJ open,['10.1136/bmjopen-2018-026604']
875,32072763,Dose-dependent reduction in body weight with LIK066 (licogliflozin) treatment in Japanese patients with obesity.,"AIMS


LIK066 (licogliflozin) is a dual sodium glucose co-transporter 1/2 inhibitor with potential benefits in weight loss. This study evaluated the efficacy, tolerability and safety of licogliflozin in Japanese adults with obesity.
MATERIALS AND METHODS


This study was a randomized, double-blind, placebo-controlled, dose-finding study to evaluate the effect of licogliflozin (2.5, 10, 25 and 50 mg once daily) in 126 Japanese patients with obesity. The primary objective was to examine the dose-response relationship of licogliflozin treatment in body weight reduction relative to placebo at 12 weeks. The secondary objectives included assessment of responder rates, change in parameters related to complications, visceral and subcutaneous fat area, and safety during 12 weeks of treatment.
RESULTS


The placebo-subtracted least square mean percentage change in body weight from baseline at week 12 was -1.99 (95% confidence interval -2.92, -0.21), -3.00 (-4.15, -1.70), -3.54 (-4.54, -2.26) and - 3.91% (-5.01, -2.77) in licogliflozin 2.5, 10, 25 and 50 mg once-daily dose groups, respectively. The proportion of responders with ≥3% reduction in body weight in the licogliflozin 2.5, 10, 25 and 50 mg once-daily dose groups were 15.8%, 55.6%, 50.0% and 56.7%, respectively, versus placebo [7.1%; P ≤0.002 for all except the 2.5 mg once-daily group (P = 0.39)]. Dose-dependent reductions were observed significantly in haemoglobin A1c, uric acid, fasting plasma glucose and potentially in the waist circumference, diastolic blood pressure and visceral fat area.
CONCLUSION


Dual inhibition of SGLT1/2 with licogliflozin treatment induced a dose-dependent reduction in body weight in Japanese patients with obesity. Treatment with licogliflozin was safe and well tolerated in this study. The study is registered with ClinicalTrials.gov (NCT03320941).",2020,"Dose-dependent reductions were observed significantly in HbA1c, uric acid, FPG and potentially in waist circumference, DBP and visceral fat area.
","['Japanese adults with obesity', 'Japanese patients with obesity', '126 Japanese patients with obesity']","['placebo', 'licogliflozin', 'LIK066 (licogliflozin']","['HbA1c, uric acid, FPG and potentially in waist circumference, DBP and visceral fat area', 'responder rates, change in parameters related to complications, visceral and subcutaneous fat area, and safety through 12\u2009weeks of treatment', 'body weight', 'efficacy, tolerability and safety', 'safe and well tolerated']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",126.0,0.165436,"Dose-dependent reductions were observed significantly in HbA1c, uric acid, FPG and potentially in waist circumference, DBP and visceral fat area.
","[{'ForeName': 'Koutaro', 'Initials': 'K', 'LastName': 'Yokote', 'Affiliation': 'Department of Endocrinology, Hematology and Gerontology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Misako', 'Initials': 'M', 'LastName': 'Sano', 'Affiliation': 'Cardio-Metabolic Clinical Development Department, Clinical Development & Analytics, Novartis Pharma K.K., Tokyo, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Tsumiyama', 'Affiliation': 'Integrated Biostatistics Japan Department, Clinical Development & Analytics, Novartis Pharma K.K., Tokyo, Japan.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Keefe', 'Affiliation': 'Rheumatology, Clinical Development & Analytics, Novartis Pharmaceuticals Corporation, East Hanover, New, Jersey.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14006']
876,30496003,Effect of Remediating Blighted Vacant Land on Shootings: A Citywide Cluster Randomized Trial.,"Objectives.  To determine if remediating blighted vacant urban land reduced firearm shooting incidents resulting in injury or death. Methods.  We conducted a cluster randomized controlled trial in which we assigned 541 randomly selected vacant lots in Philadelphia, Pennsylvania, to 110 geographically contiguous clusters and randomly assigned these clusters to a greening intervention, a less-intensive mowing and trash cleanup intervention, or a no-intervention control condition. The random assignment to the trial occurred in April and June 2013 and lasted until March 2015. In a difference-in-differences analysis, we assessed whether the 2 treatment conditions relative to the control condition reduced firearm shootings around vacant lots. Results.  During the trial, both the greening intervention, -6.8% (95% confidence interval [CI] = -10.6%, -2.7%), and the mowing and trash cleanup intervention, -9.2% (95% CI = -13.2%, -4.8%), significantly reduced shootings. There was no evidence that the interventions displaced shootings into adjacent areas. Conclusions.  Remediating vacant land with inexpensive, scalable methods, including greening or minimal mowing and trash cleanup, significantly reduced shootings that result in serious injury or death. Public Health Implications.  Cities should experiment with place-based interventions to develop effective firearm violence-reduction strategies. Trial Registration.  This trial was registered with the International Standard Randomized Controlled Trial Number (study ID ISRCTN92582209; http://www.isrctn.com/ISRCTN92582209).",2019,"During the trial, both the greening intervention, -6.8% (95% confidence interval [CI] = -10.6%, -2.7%), and the mowing and trash cleanup intervention, -9.2% (95% CI = -13.2%, -4.8%), significantly reduced shootings.","['541 randomly selected vacant lots in Philadelphia, Pennsylvania, to 110 geographically contiguous clusters and randomly assigned these clusters to a', 'on Shootings']","['Remediating Blighted Vacant Land', 'greening intervention, a less-intensive mowing and trash cleanup intervention, or a no-intervention control condition']",[],"[{'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0205283', 'cui_str': 'Contiguous (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0332583', 'cui_str': 'Green color (qualifier value)'}, {'cui': 'C0017095', 'cui_str': 'Garbages'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",[],541.0,0.318924,"During the trial, both the greening intervention, -6.8% (95% confidence interval [CI] = -10.6%, -2.7%), and the mowing and trash cleanup intervention, -9.2% (95% CI = -13.2%, -4.8%), significantly reduced shootings.","[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Moyer', 'Affiliation': 'Ruth Moyer, John M. MacDonald, and Greg Ridgeway are with the Department of Criminology, University of Pennsylvania, Philadelphia. Charles C. Branas is with the Department of Epidemiology, Columbia University Mailman School of Public Health, New York, NY.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'MacDonald', 'Affiliation': 'Ruth Moyer, John M. MacDonald, and Greg Ridgeway are with the Department of Criminology, University of Pennsylvania, Philadelphia. Charles C. Branas is with the Department of Epidemiology, Columbia University Mailman School of Public Health, New York, NY.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Ridgeway', 'Affiliation': 'Ruth Moyer, John M. MacDonald, and Greg Ridgeway are with the Department of Criminology, University of Pennsylvania, Philadelphia. Charles C. Branas is with the Department of Epidemiology, Columbia University Mailman School of Public Health, New York, NY.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Branas', 'Affiliation': 'Ruth Moyer, John M. MacDonald, and Greg Ridgeway are with the Department of Criminology, University of Pennsylvania, Philadelphia. Charles C. Branas is with the Department of Epidemiology, Columbia University Mailman School of Public Health, New York, NY.'}]",American journal of public health,['10.2105/AJPH.2018.304752']
877,30550987,A randomized controlled trial to test efficacy of digital enhancements of storybooks in support of narrative comprehension and word learning.,"Experiments with film-like story presentations have been found to be beneficial in supporting children's story comprehension and word learning. The main goal of the current study was to disentangle the effects of visual and auditory enhancements in digital books. Participants were 99 typically developing children (41 boys and 58 girls) aged 4-6 years from two public kindergartens in Bursa, Turkey. A randomized controlled trial was conducted with a control group and four experimental conditions that included all possible combinations: static illustrations with and without music/sounds and animated illustrations with and without music/sounds. In each experimental condition, children read two different storybooks twice, each time in small group sessions of 2 or 3 children. The posttest included, apart from story comprehension, expressive and receptive vocabulary tests of book-based words. Story comprehension, not word learning, benefited from visual enhancements in digital books. Music and background sounds did not stimulate story comprehension and even had a negative effect on receptive vocabulary. To explain the findings, we refer to multimedia learning principles such as temporal contiguity. Consequences for a digital storybook format are discussed.",2019,Experiments with film-like story presentations have been found to be beneficial in supporting children's story comprehension and word learning.,"['Participants were 99 typically developing children (41 boys and 58 girls) aged 4-6\u202fyears from two public kindergartens in Bursa, Turkey']",['static illustrations with and without music/sounds and animated illustrations with and without music/sounds'],"['story comprehension, expressive and receptive vocabulary tests of book-based words']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0006441', 'cui_str': 'Structure of bursa'}, {'cui': 'C0041400', 'cui_str': 'Turkey'}]","[{'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}]","[{'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0042927', 'cui_str': 'Vocabulary Tests'}, {'cui': 'C0006002', 'cui_str': 'Books'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",99.0,0.0918356,Experiments with film-like story presentations have been found to be beneficial in supporting children's story comprehension and word learning.,"[{'ForeName': 'Burcu', 'Initials': 'B', 'LastName': 'Sarı', 'Affiliation': 'Faculty of Education, Uludağ University, 16059 Bursa, Turkey; Vocational School of Social Sciences, Çanakkale Onsekiz Mart University, 17020 Çanakkale, Turkey. Electronic address: burcusari87@gmail.com.'}, {'ForeName': 'Handan Asûde', 'Initials': 'HA', 'LastName': 'Başal', 'Affiliation': 'Faculty of Education, Uludağ University, 16059 Bursa, Turkey.'}, {'ForeName': 'Zsofia K', 'Initials': 'ZK', 'LastName': 'Takacs', 'Affiliation': 'Institute of Education, ELTE Eötvös Loránd University, 1053 Budapest, Hungary.'}, {'ForeName': 'Adriana G', 'Initials': 'AG', 'LastName': 'Bus', 'Affiliation': 'Institute of Education, ELTE Eötvös Loránd University, 1053 Budapest, Hungary; Department of Language, Literature and Communication, Vrije Universiteit Amsterdam, 1081 HV Amsterdam, the Netherlands; Faculty of Arts and Education, University of Stavanger, 4036 Stavanger, Norway.'}]",Journal of experimental child psychology,['10.1016/j.jecp.2018.11.006']
878,32171637,Cognitive functioning in ultra-high risk for psychosis individuals with and without depression: Secondary analysis of findings from the NEURAPRO randomized clinical trial.,"Neurocognitive impairments are well established in both ultra-high risk (UHR) for psychosis and major depressive disorder (MDD). Despite this understanding, investigation of neurocognitive deficits in UHR individuals with MDD and its association with MDD within this population, has been scarce. Hence, this study aimed to examine any differences in neurocognition at baseline between those with MDD at baseline and those with no history of MDD, as well as determine whether neurocognitive variables are significantly associated with meeting criteria for MDD at follow-up, while controlling for relevant clinical variables, within a UHR cohort. Data analysis was conducted on 207 participants whose baseline neurocognition was assessed using Brief Assessment of Cognition for Schizophrenia, as part of a trial of omega-3 fatty acids (NEURAPRO) for UHR individuals. While baseline MDD was the strongest predictor, poorer verbal memory and higher verbal fluency were significantly associated with MDD at 12 months (p = .04 and 0.026, respectively). Further, higher processing speed was significantly associated with MDD at medium-term follow-up (p = .047). These findings outline that neurocognitive skills were independently associated with meeting criteria for MDD at follow-up within UHR individuals, with novel findings of better verbal fluency and processing speed being linked to MDD outcomes. Hence, neurocognitive performance should be considered as a marker of risk for MDD outcomes and a target for management of MDD in UHR.",2020,"Further, higher processing speed was significantly associated with MDD at medium-term follow-up (p = .047).","['207 participants whose baseline neurocognition was assessed using Brief Assessment of Cognition for Schizophrenia, as part of a trial of', 'UHR individuals with MDD', 'psychosis individuals with and without depression']","['NEURAPRO', 'omega-3 fatty acids (NEURAPRO']","['higher processing speed', 'poorer verbal memory and higher verbal fluency', 'Cognitive functioning']","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0582591', 'cui_str': 'Processing speed (observable entity)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}]",207.0,0.109403,"Further, higher processing speed was significantly associated with MDD at medium-term follow-up (p = .047).","[{'ForeName': 'Sumudu Rasangi', 'Initials': 'SR', 'LastName': 'Mallawaarachchi', 'Affiliation': 'Orygen, Parkville, Australia; The Centre for Youth Mental Health, The University of Melbourne, Melbourne, Australia. Electronic address: sumudu.mallawaarachchi@orygen.org.au.'}, {'ForeName': 'G Paul', 'Initials': 'GP', 'LastName': 'Amminger', 'Affiliation': 'Orygen, Parkville, Australia; The Centre for Youth Mental Health, The University of Melbourne, Melbourne, Australia; Department of Psychiatry and Psychotherapy, Clinical Division of Social Psychiatry, Medical University Vienna, Vienna, Austria. Electronic address: paul.amminger@orygen.org.au.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Farhall', 'Affiliation': 'Department of Psychology and Counselling, La Trobe University, Bundoora, Australia. Electronic address: j.farhall@latrobe.edu.au.'}, {'ForeName': 'Luke K', 'Initials': 'LK', 'LastName': 'Bolt', 'Affiliation': 'Department of Psychology and Counselling, La Trobe University, Bundoora, Australia.'}, {'ForeName': 'Barnaby', 'Initials': 'B', 'LastName': 'Nelson', 'Affiliation': 'The Centre for Youth Mental Health, The University of Melbourne, Melbourne, Australia. Electronic address: barnaby.nelson@orygen.org.au.'}, {'ForeName': 'Hok Pan', 'Initials': 'HP', 'LastName': 'Yuen', 'Affiliation': 'Orygen, Parkville, Australia; The Centre for Youth Mental Health, The University of Melbourne, Melbourne, Australia. Electronic address: hokpan.yuen@orygen.org.au.'}, {'ForeName': 'Patrick D', 'Initials': 'PD', 'LastName': 'McGorry', 'Affiliation': 'Orygen, Parkville, Australia; The Centre for Youth Mental Health, The University of Melbourne, Melbourne, Australia. Electronic address: pat.mcgorry@orygen.org.au.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Markulev', 'Affiliation': 'Orygen, Parkville, Australia; The Centre for Youth Mental Health, The University of Melbourne, Melbourne, Australia. Electronic address: connie.markulev@orygen.org.au.'}, {'ForeName': 'Miriam R', 'Initials': 'MR', 'LastName': 'Schäfer', 'Affiliation': 'The Centre for Youth Mental Health, The University of Melbourne, Melbourne, Australia; Department of Psychiatry and Psychotherapy, Clinical Division of Social Psychiatry, Medical University Vienna, Vienna, Austria.'}, {'ForeName': 'Nilufar', 'Initials': 'N', 'LastName': 'Mossaheb', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Clinical Division of Social Psychiatry, Medical University Vienna, Vienna, Austria. Electronic address: nilufar.mossaheb@meduniwien.ac.at.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Schlögelhofer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Clinical Division of Social Psychiatry, Medical University Vienna, Vienna, Austria. Electronic address: monika.schloegelhofer@meduniwien.ac.at.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Smesny', 'Affiliation': 'Department of Psychiatry, University Hospital Jena, Jena, Germany. Electronic address: stefan.smesny@med.uni-jena.de.'}, {'ForeName': 'Ian B', 'Initials': 'IB', 'LastName': 'Hickie', 'Affiliation': 'Brain and Mind Centre, University of Sydney, Sydney, Australia. Electronic address: Ian.hickie@sydney.edu.au.'}, {'ForeName': 'Gregor Emanuel', 'Initials': 'GE', 'LastName': 'Berger', 'Affiliation': 'Child and Adolescent Psychiatric Service of the Canton of Zurich, Zurich, Switzerland. Electronic address: gregor.berger@puk.zh.ch.'}, {'ForeName': 'Eric Y H', 'Initials': 'EYH', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, University of Hong Kong, Hong Kong. Electronic address: eyhchen@hkusua.hku.hk.'}, {'ForeName': 'Lieuwe', 'Initials': 'L', 'LastName': 'de Haan', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Centers, the Netherlands. Electronic address: l.dehaan@amc.uva.nl.'}, {'ForeName': 'Dorien H', 'Initials': 'DH', 'LastName': 'Nieman', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Centers, the Netherlands. Electronic address: d.h.nieman@amc.uva.nl.'}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Nordentoft', 'Affiliation': 'Psychiatric Centre Bispebjerg, Copenhagen, Denmark. Electronic address: merete.nordentoft@regionh.dk.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Riecher-Rössler', 'Affiliation': 'University of Basel, Basel, Switzerland. Electronic address: anita.riecher@unibas.ch.'}, {'ForeName': 'Swapna', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': 'Institute of Mental Health, Singapore, Singapore. Electronic address: swapna_verma@imh.com.sg.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Thompson', 'Affiliation': 'Orygen, Parkville, Australia; The Centre for Youth Mental Health, The University of Melbourne, Melbourne, Australia; Division of Mental Health and Wellbeing, Warwick Medical School, University of Warwick, Coventry, England, United Kingdom; North Warwickshire Early Intervention in Psychosis Service, Coventry and Warwickshire National Health Service Partnership Trust, Coventry, England, United Kingdom. Electronic address: andrew.thompson@orygen.org.au.'}, {'ForeName': 'Alison Ruth', 'Initials': 'AR', 'LastName': 'Yung', 'Affiliation': 'Orygen, Parkville, Australia; The Centre for Youth Mental Health, The University of Melbourne, Melbourne, Australia; Division of Psychology and Mental Health, University of Manchester, Manchester, England, United Kingdom; Greater Manchester Mental Health NHS Foundation Trust, Manchester, England, United Kingdom. Electronic address: alison.yung@orygen.org.au.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Allott', 'Affiliation': 'Orygen, Parkville, Australia; The Centre for Youth Mental Health, The University of Melbourne, Melbourne, Australia. Electronic address: kelly.allott@orygen.org.au.'}]",Schizophrenia research,['10.1016/j.schres.2020.03.008']
879,31996555,Suture-method versus Through-the-needle Catheters for Continuous Popliteal-sciatic Nerve Blocks: A Randomized Clinical Trial.,"BACKGROUND


The basic perineural catheter design has changed minimally since inception, with the catheter introduced through or over a straight needle. The U.S. Food and Drug Administration recently cleared a novel perineural catheter design comprising a catheter attached to the back of a suture-shaped needle that is inserted, advanced along the arc of its curvature pulling the catheter past the target nerve, and then exited through the skin in a second location. The authors hypothesized that analgesia would be noninferior using the new versus traditional catheter design in the first two days after painful foot/ankle surgery with a primary outcome of average pain measured with the Numeric Rating Scale.
METHODS


Subjects undergoing painful foot or ankle surgery with a continuous supraparaneural popliteal-sciatic nerve block 5 cm proximal to the bifurcation were randomized to either a suture-type or through-the-needle catheter and subsequent 3-day 0.2% ropivacaine infusion (basal 6 ml/h, bolus 4 ml, lockout 30 min). Subjects received daily follow-up for the first four days after surgery, including assessment for evidence of malfunction or dislodgement of the catheters.
RESULTS


During the first two postoperative days the mean ± SD average pain scores were lower in subjects with the suture-catheter (n = 35) compared with the through-the-needle (n = 35) group (2.7 ± 2.4 vs. 3.4 ± 2.4) and found to be statistically noninferior (95% CI, -1.9 to 0.6; P < 0.001). No suture-style catheter was completely dislodged (0%), whereas the tips of three (9%) traditional catheters were found outside of the skin before purposeful removal on postoperative day 3 (P = 0.239).
CONCLUSIONS


Suture-type perineural catheters provided noninferior analgesia compared with traditional catheters for continuous popliteal-sciatic blocks after painful foot and ankle surgery. The new catheter design appears to be a viable alternative to traditional designs used for the past seven decades.",2020,"During the first two postoperative days the mean ± SD average pain scores were lower in subjects with the suture-catheter (n = 35) compared with the through-the-needle (n = 35) group (2.7 ± 2.4 vs. 3.4 ± 2.4) and found to be statistically noninferior (95% CI, -1.9 to 0.6; P < 0.001).","['Continuous Popliteal-sciatic Nerve Blocks', 'Subjects undergoing painful foot or ankle surgery with a continuous supraparaneural popliteal-sciatic nerve block 5 cm proximal to the bifurcation']","['Suture-type perineural catheters provided noninferior analgesia', 'traditional catheters', 'Suture-method versus Through-the-needle Catheters', 'suture-type or through-the-needle catheter and subsequent 3-day 0.2% ropivacaine infusion']","['suture-style catheter', 'average pain', 'mean ± SD average pain scores']","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0442037', 'cui_str': 'Popliteal (qualifier value)'}, {'cui': 'C0394735', 'cui_str': 'Injection of anesthetic agent into sciatic nerve (procedure)'}, {'cui': 'C0857248', 'cui_str': 'Painful feet'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation (procedure)'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0491233', 'cui_str': 'Needle catheter (physical object)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",,0.0657825,"During the first two postoperative days the mean ± SD average pain scores were lower in subjects with the suture-catheter (n = 35) compared with the through-the-needle (n = 35) group (2.7 ± 2.4 vs. 3.4 ± 2.4) and found to be statistically noninferior (95% CI, -1.9 to 0.6; P < 0.001).","[{'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Finneran', 'Affiliation': 'From the Departments of Anesthesiology (J.J.F., M.W.S., R.A.G., E.T.S., M.U.A., W.B.A., B.M.I.) Orthopedic Surgery (D.J.D., A.K.S., W.T.K.), University of California San Diego, San Diego, California Outcomes Research Consortium, Cleveland, Ohio (J.J.F., M.W.S., R.A.G., D.Y., E.J.M., B.M.I.) Department of Quantitative Health Sciences and Outcomes Research, Cleveland Clinic, Cleveland, Ohio (D.Y., E.J.M.).'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Swisher', 'Affiliation': ''}, {'ForeName': 'Rodney A', 'Initials': 'RA', 'LastName': 'Gabriel', 'Affiliation': ''}, {'ForeName': 'Engy T', 'Initials': 'ET', 'LastName': 'Said', 'Affiliation': ''}, {'ForeName': 'Maryann U', 'Initials': 'MU', 'LastName': 'Abanobi', 'Affiliation': ''}, {'ForeName': 'Wendy B', 'Initials': 'WB', 'LastName': 'Abramson', 'Affiliation': ''}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Dalstrom', 'Affiliation': ''}, {'ForeName': 'Alexandra K', 'Initials': 'AK', 'LastName': 'Schwartz', 'Affiliation': ''}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Kent', 'Affiliation': ''}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Mascha', 'Affiliation': ''}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Ilfeld', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003145']
880,31741148,Comparison of navigated laser and conventional single-spot laser system for induced pain during panretinal photocoagulation.,"To compare the panretinal photocoagulation (PRP)-induced pain response between novel navigated laser (Navilas) and conventional single-spot laser. The eyes were randomly assigned to Navilas or conventional laser. Contralateral eyes underwent PRP with the other system with 30 min resting interval. Pulse duration was 100 ms in conventional laser and 30 ms or 100 ms in Navilas and power setting was enough to create gray-white light burn on both devices. Pain response was evaluated by verbal scale (VS) (0-4) and visual analog scale (VAS) (0-10) after each PRP application. The mean age of 70 patients (140 eyes) was 62.52 ± 9.49 years. Mean power and spot numbers for Navilas and conventional laser were 291.9 ± 85.3 mW vs 368.4 ± 72.0 mW, and 375.4 ± 108.4 vs 374.2 ± 105.0 (p < 0.001 and p = 0.53, respectively). Pain scores for Navilas and conventional laser were 1.19 ± 0.73 and 1.99 ± 0.84 for VS and 2.41 ± 1.65 and 4.74 ± 2.17 for VAS (p < 0.001 and p < 0.001). More comfortable PRP is achieved with Navilas system in comparison with conventional single-spot laser system. However, small number of patients treated with same pulse duration and different contact lenses used for two systems should be taken into consideration. Besides, we did not report comparative clinical efficiency of either laser system.",2020,Pain scores for Navilas and conventional laser were 1.19 ± 0.73 and 1.99 ± 0.84 for VS and 2.41 ± 1.65 and 4.74 ± 2.17 for VAS (p < 0.001 and p < 0.001).,"['The mean age of 70 patients (140 eyes) was 62.52 ± 9.49 years', 'induced pain during panretinal photocoagulation']","['panretinal photocoagulation (PRP)-induced pain response between novel navigated laser (Navilas) and conventional single-spot laser', 'navigated laser and conventional single-spot laser system', 'conventional laser and 30 ms or 100 ms in Navilas and power setting', 'Navilas or conventional laser']","['Pain scores', 'Mean power and spot numbers for Navilas and conventional laser', 'Pain response', 'verbal scale (VS) (0-4) and visual analog scale (VAS']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0730064', 'cui_str': 'Scatter retinal laser photocoagulation'}]","[{'cui': 'C0730064', 'cui_str': 'Scatter retinal laser photocoagulation'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}, {'cui': 'C3873738', 'cui_str': 'Laser system'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",70.0,0.0310392,Pain scores for Navilas and conventional laser were 1.19 ± 0.73 and 1.99 ± 0.84 for VS and 2.41 ± 1.65 and 4.74 ± 2.17 for VAS (p < 0.001 and p < 0.001).,"[{'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Polat', 'Affiliation': 'Ophthalmology Clinic, Afyonkarahisar State Hospital, Orhangazi Mah. Nedim Helvacıoğlu Cd. No: 73, 03030, Afyonkarahisar, Turkey. dr_onurpolatt@hotmail.com.'}, {'ForeName': 'Sibel', 'Initials': 'S', 'LastName': 'Inan', 'Affiliation': 'Faculty of Medicine, Department of Ophthalmology, Afyonkarahisar Health Sciences University, Afyonkarahisar, Turkey.'}, {'ForeName': 'Zeki', 'Initials': 'Z', 'LastName': 'Baysal', 'Affiliation': 'Ophthalmology Clinic, Batman State Hospital, Batman, Turkey.'}, {'ForeName': 'Safiye', 'Initials': 'S', 'LastName': 'Yigit', 'Affiliation': 'Ophthalmology Clinic, Gerede State Hospital, Bolu, Turkey.'}, {'ForeName': 'Umit Ubeyt', 'Initials': 'UU', 'LastName': 'Inan', 'Affiliation': 'Ophthalmology Clinic, Park Hayat Hospital, Afyonkarahisar, Turkey.'}]",Lasers in medical science,['10.1007/s10103-019-02886-2']
881,31932389,"Efficacy of a topical herbal and mineral formulation (Dynamiclear) for the treatment of herpes simplex labialis in the community setting: study protocol for a randomised, double-blind placebo-controlled trial.","INTRODUCTION


Herpes simplex labialis (HSL) is a common infection that can cause painful lesions on the oral mucosa, commonly referred to as cold sores. Current biomedical treatments include topical aciclovir, which reduces the episode duration by an average of 0.5 days. This study will examine the efficacy and tolerability of an over-the-counter topical treatment, Dynamiclear in reducing duration and severity of HSL episodes.
METHODS AND ANALYSIS


This prospective, randomised, double-blind, placebo-controlled, multi-centre trial will recruit a minimum of 292 adult participants across Australia and New Zealand who present with a cold sore within 48 hours of onset. They will be randomly allocated in a 2:1 ratio to receive either topical Dynamiclear (active) or placebo. Dynamiclear's active ingredients are  Hypericum perforatum ,  Calendula Officinalis  and copper sulfate. A single topical treatment of active or placebo will be applied by a pharmacy-based investigator, and participants will be provided with a viral swab kit to confirm presence of herpes virus 1 or 2 from ulcerated lesions. Participants will receive reminders by email and/or SMS to complete an online daily diary assessing their cold sore lesion using a visual guide, and recording other symptoms on numeric scales until healed. The primary outcome variable is median duration of HSL episode in days (participant evaluated) from presentation to return to normal skin. Secondary outcomes include severity of lesion pain, itching, burning and tingling during the symptomatic phase and proportion of lesions progressing to ulceration.
ETHICS AND DISSEMINATION


Australian ethics approval from Western Sydney University Human Research Ethics Committee, ref: H12776. New Zealand Ethics approval from The Health and Disability Ethics Committees (HDEC) ref: 18/CEN/151. Results will be published in a peer-reviewed academic journal, presented at academic meetings and reported to participants TRIAL REGISTRATION NUMBERS: Australia and New Zealand Clinical Trials Registry (ACTRN12618000890235); Universal Trial Number (UTN) (U1111-1233-2426).",2020,"Secondary outcomes include severity of lesion pain, itching, burning and tingling during the symptomatic phase and proportion of lesions progressing to ulceration.
","['292 adult participants across Australia and New Zealand who present with a cold sore within 48\u2009hours of onset', 'herpes simplex labialis in the community setting', 'Herpes simplex labialis (HSL']","['placebo', 'topical Dynamiclear (active) or placebo', 'topical herbal and mineral formulation (Dynamiclear']","['efficacy and tolerability', 'severity of lesion pain, itching, burning and tingling during the symptomatic phase and proportion of lesions progressing to ulceration', 'median duration of HSL episode in days (participant evaluated) from presentation to return to normal skin']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0019345', 'cui_str': 'Herpes Simplex, Labial'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0376667', 'cui_str': 'Herbal'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C2242996', 'cui_str': 'Tingling'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C3887532', 'cui_str': 'Ulceration (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}]",292.0,0.763889,"Secondary outcomes include severity of lesion pain, itching, burning and tingling during the symptomatic phase and proportion of lesions progressing to ulceration.
","[{'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Armour', 'Affiliation': 'NICM Health Research Institute, Western Sydney University, Penrith, New South Wales, Australia M.Armour@westernsydney.edu.au.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Semprini', 'Affiliation': 'NICM Health Research Institute, Western Sydney University, Penrith, New South Wales, Australia.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Ee', 'Affiliation': 'NICM Health Research Institute, Western Sydney University, Penrith, New South Wales, Australia.'}, {'ForeName': 'Lois', 'Initials': 'L', 'LastName': 'MacCullagh', 'Affiliation': 'NICM Health Research Institute, Western Sydney University, Penrith, New South Wales, Australia.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Shortt', 'Affiliation': 'NICM Health Research Institute, Western Sydney University, Penrith, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-031876']
882,31932392,"Evaluation of iLead, a generic implementation leadership intervention: mixed-method preintervention-postintervention design.","OBJECTIVES


The present study aimed to evaluate the iLead intervention and to investigate whether or not transfer of training can be supported by contextualising the intervention (recruiting all managers from one branch of the organisation while focusing on one implementation case, as well as training senior management).
DESIGN


A pre-evaluation-postevaluation design was applied using mixed methods with process and effect surveys and interviews to measure the effects on three levels.
SETTING


Healthcare managers from Stockholm's regional healthcare organisation were invited to the training.
PARTICIPANTS


52 managers participated in the iLead intervention. Group 1 consisted of 21 managers from different organisations and with different implementation cases. Group 2, representing the contextualised group, consisted of 31 managers from the same organisation, working on the same implementation case, where senior management also received training.
INTERVENTION


iLead is an intervention where healthcare managers are trained in implementation leadership based on the full-range leadership model.
PRIMARY OUTCOME MEASURES


Reactions, knowledge and implementation leadership are measured.
RESULTS


Quantitative and qualitative analyses indicate that iLead was perceived to be of high quality and capable of increasing participants' knowledge. Mixed effects were found regarding changes in behaviours. The contextualisation did not have a boosting effect on behaviour change. Hence, group 2 did not increase its active implementation leadership in comparison with group 1.
CONCLUSIONS


iLead introduces a new approach to how implementation leadership can be trained when knowledge of effective leadership for implementations is combined with findings on the importance of environmental factors for the transfer of training. Even though managers reported general positive effects, transfer was not facilitated through the contextualisation of the intervention. There is a need to further develop approaches to help participants subsequently apply the learnt skills in their work environment.",2020,"RESULTS


Quantitative and qualitative analyses indicate that iLead was perceived to be of high quality and capable of increasing participants' knowledge.","[""Healthcare managers from Stockholm's regional healthcare organisation were invited to the training"", '52 managers participated in the iLead intervention']","['iLead intervention', 'senior management also received training']","['Reactions, knowledge and implementation leadership are measured', 'active implementation leadership']","[{'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0335141', 'cui_str': 'Manager (occupation)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0023181', 'cui_str': 'Leadership'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]",52.0,0.0259686,"RESULTS


Quantitative and qualitative analyses indicate that iLead was perceived to be of high quality and capable of increasing participants' knowledge.","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Richter', 'Affiliation': 'Department of Learning, Informatics, Management and Ethics, Medical Management Centre, Karolinska Institute, Stockholm, Sweden anne.richter@ki.se.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Lornudd', 'Affiliation': 'Department of Learning, Informatics, Management and Ethics, Medical Management Centre, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Ulrica', 'Initials': 'U', 'LastName': 'von Thiele Schwarz', 'Affiliation': 'Department of Learning, Informatics, Management and Ethics, Medical Management Centre, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lundmark', 'Affiliation': 'Department of Learning, Informatics, Management and Ethics, Medical Management Centre, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Mosson', 'Affiliation': 'Department of Learning, Informatics, Management and Ethics, Medical Management Centre, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Eskner Skoger', 'Affiliation': 'Swedish Psychological Association, Stockholm, Sweden.'}, {'ForeName': 'Tatja', 'Initials': 'T', 'LastName': 'Hirvikoski', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institute, Stockholm, Sweden.""}, {'ForeName': 'Henna', 'Initials': 'H', 'LastName': 'Hasson', 'Affiliation': 'Department of Learning, Informatics, Management and Ethics, Medical Management Centre, Karolinska Institute, Stockholm, Sweden.'}]",BMJ open,['10.1136/bmjopen-2019-033227']
883,31948990,Cost-effectiveness of total knee replacement in addition to non-surgical treatment: a 2-year outcome from a randomised trial in secondary care in Denmark.,"OBJECTIVE


To assess the 24-month cost-effectiveness of total knee replacement (TKR) plus non-surgical treatment compared with non-surgical treatment with the option of later TKR if needed.
METHODS


100 adults with moderate-to-severe knee osteoarthritis found eligible for TKR by an orthopaedic surgeon in secondary care were randomised to TKR plus 12 weeks of supervised non-surgical treatment (exercise, education, diet, insoles and pain medication) or to supervised non-surgical treatment alone. Including quality-adjusted life years (QALYs) data from baseline, 3, 6, 12 and 24 months, effectiveness was measured as change at 24 months. Healthcare costs and transfer payments were derived from national registries. Incremental healthcare costs, and incremental cost-effectiveness ratios (ICERs) were calculated. A probabilistic sensitivity analysis was conducted and the probability of cost-effectiveness was estimated at the 22 665 Euros/QALY threshold defined by the National Institute for Health and Care Excellence.
RESULTS


TKR plus non-surgical treatment was more expensive (mean of 23 076 vs 14 514 Euros) but also more effective than non-surgical treatment (mean 24-month improvement in QALY of 0.195 vs 0.056). While cost-effective in the unadjusted scenario (ICER of 18 497 Euros/QALY), TKR plus non-surgical treatment was not cost-effective compared with non-surgical treatment with the option of later TKR if needed in the adjusted (age, sex and baseline values), base-case scenario (ICER of 32 611 Euros/QALY) with a probability of cost-effectiveness of 23.2%. Including deaths, TKR plus non-surgical treatment was still not cost-effective (ICERs of 46 277 to 64 208 Euros/QALY).
CONCLUSIONS


From a 24-month perspective, TKR plus non-surgical treatment does not appear to be cost-effective compared with non-surgical treatment with the option of later TKR if needed in patients with moderate-to-severe knee osteoarthritis and moderate intensity pain in secondary care in Denmark. Results were sensitive to changes, highlighting the need for further confirmatory research also assessing the long-term cost-effectiveness of TKR.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov (NCT01410409).",2020,"RESULTS


TKR plus non-surgical treatment was more expensive (mean of 23 076 vs 14 514 Euros) but also more effective than non-surgical treatment (mean 24-month improvement in QALY of 0.195 vs 0.056).","['100 adults with moderate-to-severe knee osteoarthritis found eligible for TKR by an orthopaedic surgeon in secondary care', 'secondary care in Denmark']","['TKR plus 12 weeks of supervised non-surgical treatment (exercise, education, diet, insoles and pain medication) or to supervised non-surgical treatment alone', 'total knee replacement', 'total knee replacement (TKR) plus non-surgical treatment', 'TKR plus non-surgical treatment']","['Healthcare costs and transfer payments', 'Incremental healthcare costs, and incremental cost-effectiveness ratios (ICERs', 'probability of cost-effectiveness', 'quality-adjusted life years (QALYs) data', 'Cost-effectiveness']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0334891', 'cui_str': 'Orthopedists'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2363849', 'cui_str': 'Non-surgical treatment'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C3873740', 'cui_str': 'Insole'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0080071', 'cui_str': 'QALY'}]",100.0,0.0315942,"RESULTS


TKR plus non-surgical treatment was more expensive (mean of 23 076 vs 14 514 Euros) but also more effective than non-surgical treatment (mean 24-month improvement in QALY of 0.195 vs 0.056).","[{'ForeName': 'Søren Thorgaard', 'Initials': 'ST', 'LastName': 'Skou', 'Affiliation': 'Research Unit for Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, Syddansk Universitet, Odense, Syddanmark, Denmark stskou@health.sdu.dk.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Roos', 'Affiliation': 'Research Unit for Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, Syddansk Universitet, Odense, Syddanmark, Denmark.'}, {'ForeName': 'Mogens', 'Initials': 'M', 'LastName': 'Laursen', 'Affiliation': 'Orthopedic Surgery Research Unit, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Arendt-Nielsen', 'Affiliation': 'Center for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Rasmussen', 'Affiliation': 'Orthopedic Surgery Research Unit, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Simonsen', 'Affiliation': 'Orthopedic Surgery Research Unit, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Ibsen', 'Affiliation': 'I2minds, Aarhus, Denmark.'}, {'ForeName': 'Arendse T', 'Initials': 'AT', 'LastName': 'Larsen', 'Affiliation': 'VIVE - The Danish Center for Social Science Research, Copenhagen, Hovedstaden, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Kjellberg', 'Affiliation': 'VIVE - The Danish Center for Social Science Research, Copenhagen, Hovedstaden, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-033495']
884,31948992,Improving the quality of life of patients with breast cancer-related lymphoedema by lymphaticovenous anastomosis (LVA): study protocol of a multicentre randomised controlled trial.,"INTRODUCTION


Early breast cancer detection and advancements in treatment options have resulted in an increase of breast cancer survivors. An increasing number of women are living with the long-term effects of breast cancer treatment, making the quality of survivorship an increasingly important goal. Breast cancer-related lymphoedema (BCRL) is one of the most underestimated complications of breast cancer treatment with a reported incidence of 20%. A microsurgical technique called lymphaticovenous anastomosis (LVA) might be a promising treatment modality for patients with BCRL. The main objective is to assess whether LVA is more effective than the current standard therapy (conservative treatment) in terms of improvement in quality of life and weather it is cost-effective.
METHODS AND ANALYSIS


A multicentre, randomised controlled trial, carried out in two academic and two community hospitals in the Netherlands. The study population includes 120 women over the age of 18 who have undergone treatment for breast cancer including axillary treatment (sentinel lymph node biopsy or axillary lymph node dissection) and/or axillary radiotherapy, presenting with an early stage lymphoedema of the arm, viable lymphatic vessels and received at least 3 months conservative treatment. Sixty participants will undergo the LVA operation and the other sixty will continue their regular conservative treatment, both with a follow-up of 24 months. The primary outcome is the health-related quality of life. Secondary outcomes are societal costs, quality adjusted life years, cost-effectiveness ratio, discontinuation rate of conservative treatment and excess limb volume.
ETHICS AND DISSEMINATION


The study was approved by the Ethics Committee of Maastricht University Medical Center (METC) on 19 December 2018 (NL67059.068.18). The results of this study will be disseminated in presentations at academic conferences, publications in peer-reviewed journals and other news media.
TRIAL REGISTRATION NUMBER


NCT02790021; Pre-results.",2020,A microsurgical technique called lymphaticovenous anastomosis (LVA) might be a promising treatment modality for patients with BCRL.,"['patients with breast cancer-related lymphoedema by lymphaticovenous anastomosis (LVA', 'Sixty participants will undergo the LVA operation and the other sixty will continue their regular conservative treatment, both with a follow-up of 24 months', 'two academic and two community hospitals in the Netherlands', 'patients with BCRL', 'Breast cancer-related lymphoedema (BCRL', '120 women over the age of 18 who have undergone treatment for breast cancer including axillary treatment (sentinel lymph node biopsy or axillary lymph node dissection) and/or axillary radiotherapy, presenting with an early stage lymphoedema of the arm, viable lymphatic vessels and received at least 3 months conservative treatment']","['LVA', 'microsurgical technique called lymphaticovenous anastomosis (LVA']","['health-related quality of life', 'societal costs, quality adjusted life years, cost-effectiveness ratio, discontinuation rate of conservative treatment and excess limb volume', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0459914', 'cui_str': 'Conservative Management'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0020003', 'cui_str': 'Hospitals, Community'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C0796693', 'cui_str': 'Sentinel Lymph Node Biopsy'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0443348', 'cui_str': 'Viable (qualifier value)'}, {'cui': 'C0229889', 'cui_str': 'Structure of lymphatic vessel'}]","[{'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0459914', 'cui_str': 'Conservative Management'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",60.0,0.0893128,A microsurgical technique called lymphaticovenous anastomosis (LVA) might be a promising treatment modality for patients with BCRL.,"[{'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Wolfs', 'Affiliation': 'Plastic, Reconstructive, and Hand Surgery, Maastricht University Medical Centre+, Maastricht, The Netherlands.'}, {'ForeName': 'Jop', 'Initials': 'J', 'LastName': 'Beugels', 'Affiliation': 'Plastic, Reconstructive, and Hand Surgery, Maastricht University Medical Centre+, Maastricht, The Netherlands.'}, {'ForeName': 'Merel', 'Initials': 'M', 'LastName': 'Kimman', 'Affiliation': 'Clinical Epidemiology and Medical Technology Assessment, Maastricht Universitair Medisch Centrum+, Maastricht, The Netherlands.'}, {'ForeName': 'Andrzej A', 'Initials': 'AA', 'LastName': 'Piatkowski de Grzymala', 'Affiliation': 'Plastic, Reconstructive, and Hand Surgery, Maastricht University Medical Centre+, Maastricht, The Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Heuts', 'Affiliation': 'Surgery, Maastricht University Medical Centre+, Maastricht, The Netherlands.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Keuter', 'Affiliation': 'Plastic, Reconstructive, and Hand Surgery, Maastricht University Medical Centre+, Maastricht, The Netherlands.'}, {'ForeName': 'Hanneke', 'Initials': 'H', 'LastName': 'Tielemans', 'Affiliation': 'Plastic, Reconstructive & Hand Surgery, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Ulrich', 'Affiliation': 'Plastic, Reconstructive & Hand Surgery, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'van der Hulst', 'Affiliation': 'Plastic, Reconstructive, and Hand Surgery, Maastricht University Medical Centre+, Maastricht, The Netherlands.'}, {'ForeName': 'Shan Shan', 'Initials': 'SS', 'LastName': 'Qiu', 'Affiliation': 'Plastic, Reconstructive, and Hand Surgery, Maastricht University Medical Centre+, Maastricht, The Netherlands shanshan.qiushao@mumc.nl.'}]",BMJ open,['10.1136/bmjopen-2019-035337']
885,32005780,Breastfeeding peer counselling for mothers of preterm neonates: protocol of a stepped-wedge cluster randomised controlled trial.,"INTRODUCTION


Among preterm infants, mother's own milk feeding reduces neonatal morbidity and decreases the length of hospital stay. However, breastfeeding rates and duration are lower than among term infants. It is reported that peer counselling is effective in increasing breast feeding in term infants in low-income and middle-income countries, but results are mixed in high-income countries. We aim to investigate herein whether peer counselling may be a feasible and effective breastfeeding support among preterm infants in French-speaking high-income countries.
METHODS AND ANALYSIS


Eight European centres will participate in this stepped-wedge cluster randomised controlled trial. We plan to include 2400 hospitalised neonates born before 35 gestational weeks. Each centre will begin with an observational period. Every 3 months, a randomised cluster (centre) will begin the interventional period with peer counsellors until the end of the study. The counsellors will be trained and supervised by the trained nurses. They will have a weekly contact with participating mothers, with a face-to-face meeting at least once every fortnight. During these meetings, peer counsellors will listen to mothers' concerns, share experiences and help the mother with their own knowledge of breast feeding. The main outcome is breastfeeding rate at 2 months corrected age. Secondary outcomes are breastfeeding rates at hospital discharge and at 6 months, breastfeeding duration and severe neonatal morbidity and mortality. The mental health of the mother, mother-infant bonding and infant behaviour will be assessed using self-report questionnaires. A neurodevelopmental follow-up, a cost-effectiveness analysis and a cost-consequence at 2 years corrected age will be performed among infants in a French subgroup.
ETHICS AND DISSEMINATION


French, Belgian and Swiss ethics committees gave their agreement. Publications in peer-reviewed journals are planned on breast feeding, mental health and economic outcomes.
TRIAL REGISTRATION NUMBER


NCT03156946.",2020,"It is reported that peer counselling is effective in increasing breast feeding in term infants in low-income and middle-income countries, but results are mixed in high-income countries.","['2400 hospitalised neonates born before 35 gestational weeks', 'preterm infants in French-speaking high-income countries', 'mothers of preterm neonates', 'infants in a French subgroup', 'preterm infants']",['Breastfeeding peer counselling'],"['breastfeeding rate', 'neonatal morbidity', 'length of hospital stay', 'breastfeeding rates at hospital discharge and at 6 months, breastfeeding duration and severe neonatal morbidity and mortality']","[{'cui': 'C4517656', 'cui_str': 'Two thousand four hundred'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0948433', 'cui_str': 'High income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.151722,"It is reported that peer counselling is effective in increasing breast feeding in term infants in low-income and middle-income countries, but results are mixed in high-income countries.","[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Laborie', 'Affiliation': 'Hopital Femme Mère Enfant, Neonatology, Hospices Civils de Lyon, Bron, France sophie.laborie@chu-lyon.fr.'}, {'ForeName': 'Angelique', 'Initials': 'A', 'LastName': 'Denis', 'Affiliation': 'Service de Biostatistique-Bioinformatique, Pôle Santé Publique, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Horsch', 'Affiliation': 'Institute of Higher Education and Research in Healthcare, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Occelli', 'Affiliation': 'Pôle Santé Publique, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Margier', 'Affiliation': 'Public Health, University Hospital Centre Lyon, Lyon, France.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Morisod Harari', 'Affiliation': 'Child and Adolescent Psychiatry, Centre Hospitalier Universitaire Vaudois, Lausanne, Vaud, Switzerland.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Claris', 'Affiliation': 'Hopital Femme Mère Enfant, Neonatology, Hospices Civils de Lyon, Bron, Auvergne-Rhône-Alpes, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Touzet', 'Affiliation': 'Pôle Santé Publique, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Celine Julie', 'Initials': 'CJ', 'LastName': 'Fischer Fumeaux', 'Affiliation': 'Woman-Mother-Child, Lausanne University Hospital, Lausanne, Switzerland.'}]",BMJ open,['10.1136/bmjopen-2019-032910']
886,31259767,HIV stigma and viral load among African-American women receiving treatment for HIV.,"OBJECTIVE


African-American women are more likely than other women in the United States to experience poor HIV-related health; HIV stigma may contribute to these outcomes. This study assessed the relationship between HIV stigma and viral load, over time, among a sample of African-American women receiving treatment for HIV, and explored social support and depressive symptoms as mediators.
DESIGN


Secondary analysis of longitudinal data.
METHODS


Data came from a randomized trial of an intervention to reduce HIV stigma among African-American women in HIV care in Chicago, Illinois and Birmingham, Alabama. Sociodemographic and psychosocial data were collected at up to six study visits over 14 months. Viral loads were extracted from medical records during the study period. Generalized linear mixed effects models were used to estimate associations among overall, internalized, and enacted HIV stigma and viral load over time. Mediation analyses were used to estimate indirect effects via social support and depressive symptoms.
RESULTS


Data from 234 women were analyzed. Overall HIV stigma was significantly associated with subsequent viral load (adjusted β = 0.24, P = 0.005). Both between-subject (adjusted β = 0.74, P < 0.001) and within-subject (adjusted β = 0.34, P = 0.005) differences in enacted stigma were associated with viral load. Neither social support nor depressive symptoms were statistically significant mediators.
CONCLUSION


Ongoing experiences of HIV stigmatization may contribute to increased viral load among African-American women in primary HIV care. Interventions should aim to alleviate the consequences of stigma experienced by patients and prevent future stigmatization.",2019,"Overall HIV stigma was significantly associated with subsequent viral load (adjusted β = 0.24, P = 0.005).","['African-American women in HIV care in Chicago, Illinois and Birmingham, Alabama', 'African-American women', 'African-American women in primary HIV care', '234 women were analyzed', 'African-American women receiving treatment for HIV', 'African-American women receiving treatment for HIV, and explored social support and depressive symptoms as mediators']",[],"['Overall HIV stigma', 'enacted stigma', 'Sociodemographic and psychosocial data', 'depressive symptoms', 'HIV stigma', 'overall, internalized, and enacted HIV stigma and viral load over time', 'Viral loads', 'HIV stigma and viral load']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C0001895', 'cui_str': 'Alabama'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0037438'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",234.0,0.0469557,"Overall HIV stigma was significantly associated with subsequent viral load (adjusted β = 0.24, P = 0.005).","[{'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Kemp', 'Affiliation': 'Department of Global Health.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Lipira', 'Affiliation': 'Department of Health Services.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Huh', 'Affiliation': 'School of Social Work.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Nevin', 'Affiliation': 'Department of Global Health.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Turan', 'Affiliation': 'School of Public Health, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Simoni', 'Affiliation': 'Department of Global Health.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Cohn', 'Affiliation': 'Division of Infectious Diseases, Northwestern University Feinberg School of Medicine.'}, {'ForeName': 'Mieoak', 'Initials': 'M', 'LastName': 'Bahk', 'Affiliation': 'Ruth M. Rothstein CORE Center, Chicago, Illinois.'}, {'ForeName': 'Baiba', 'Initials': 'B', 'LastName': 'Berzins', 'Affiliation': 'Division of Infectious Diseases, Northwestern University Feinberg School of Medicine.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Andrasik', 'Affiliation': 'Department of Global Health.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Mugavero', 'Affiliation': 'Department of Medicine, School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Rao', 'Affiliation': 'Department of Global Health.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002212']
887,31116355,Effect of the PCSK9 Inhibitor Evolocumab on Total Cardiovascular Events in Patients With Cardiovascular Disease: A Prespecified Analysis From the FOURIER Trial.,"Importance


The PCSK9 inhibitor evolocumab reduced low-density lipoprotein cholesterol and first cardiovascular events in the Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk (FOURIER) trial, but patients remain at high risk of recurrent cardiovascular events.
Objective


To evaluate the effect of evolocumab on total cardiovascular events, given the importance of total number of cardiovascular events to patients, clinicians, and health economists.
Design, Setting, and Participants


Secondary analysis of a randomized, double-blind clinical trial. The FOURIER trial compared evolocumab or matching placebo and followed up patients for a median of 2.2 years. The study included 27 564 patients with stable atherosclerotic disease receiving statin therapy. Data were analyzed between May 2017 and February 2019.
Main Outcomes and Measures


The primary end point (PEP) was time to first cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization; the key secondary end point was time to first cardiovascular death, myocardial infarction, or stroke. In a prespecified analysis, total cardiovascular events were evaluated between treatment arms.
Results


The mean age of patients was 63 years, 69% of patients were taking high-intensity statin therapy, and the median LDL-C at baseline was 92 mg/dL (to convert to millimoles per liter, multiply by 0.0259). There were 2907 first PEP events and 4906 total PEP events during the trial. Evolocumab reduced total PEP events by 18% (incidence rate ratio [RR], 0.82; 95% CI, 0.75-0.90; P < .001) including both first events (hazard ratio, 0.85; 95% CI, 0.79-0.92; P < .001) and subsequent events (RR, 0.74; 95% CI, 0.65-0.85). There were 2192 total primary events in the evolocumab group and 2714 total events in the placebo group. For every 1000 patients treated for 3 years, evolocumab prevented 22 first PEP events and 52 total PEP events. Reductions in total events were driven by fewer total myocardial infarctions (RR, 0.74; 95% CI, 0.65-0.84; P < .001), strokes (RR, 0.77; 95% CI, 0.64-0.93; P = .007), and coronary revascularizations (RR, 0.78; 95% CI, 0.71-0.87; P < .001).
Conclusions and Relevance


The addition of the PCSK9 inhibitor evolocumab to statin therapy improved clinical outcomes, with significant reductions in total PEP events, driven by decreases in myocardial infarction, stroke, and coronary revascularization. More than double the number of events were prevented with evolocumab vs placebo as compared with the analysis of only first events. These data provide further support for the benefit of continuing aggressive lipid-lowering therapy to prevent recurrent cardiovascular events.
Trial Registration


ClinicalTrials.gov identifier: NCT01764633.",2019,"Evolocumab reduced total PEP events by 18% (incidence rate ratio [RR], 0.82; 95% CI, 0.75-0.90; P < .001) including both first events (hazard ratio, 0.85; 95% CI, 0.79-0.92; P < .001) and subsequent events (RR, 0.74; 95% CI, 0.65-0.85).","['27\u202f564 patients with stable atherosclerotic disease receiving statin therapy', 'Patients With Cardiovascular Disease']","['placebo', 'evolocumab or matching placebo', 'evolocumab', 'PCSK9 Inhibitor Evolocumab', 'evolocumab vs placebo']","['strokes', 'total events', 'total myocardial infarctions', 'total PEP events', 'total cardiovascular events', 'coronary revascularizations', '4906 total PEP events', 'Total Cardiovascular Events', 'low-density lipoprotein cholesterol and first cardiovascular events', 'time to first cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization; the key secondary end point was time to first cardiovascular death, myocardial infarction, or stroke', 'myocardial infarction, stroke, and coronary revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C4522007', 'cui_str': 'Proprotein convertase subtilisin/kexin type 9 inhibitor'}]","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0359587', 'cui_str': 'Peptamen'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1272693', 'cui_str': 'Ended'}]",27564.0,0.375442,"Evolocumab reduced total PEP events by 18% (incidence rate ratio [RR], 0.82; 95% CI, 0.75-0.90; P < .001) including both first events (hazard ratio, 0.85; 95% CI, 0.79-0.92; P < .001) and subsequent events (RR, 0.74; 95% CI, 0.65-0.85).","[{'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Masschusetts.""}, {'ForeName': 'Terje R', 'Initials': 'TR', 'LastName': 'Pedersen', 'Affiliation': 'Oslo University Hospital, Ullevål and Medical Faculty, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Zbigniew A', 'Initials': 'ZA', 'LastName': 'Gaciong', 'Affiliation': 'Department of Internal Medicine, Hypertension and Vascular Diseases, The Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Ceska', 'Affiliation': 'Center for Preventive Cardiology, 3rd Internal Medicine Clinic, University General Hospital and Charles University 1st Medical Faculty, Prague, Czech Republic.'}, {'ForeName': 'Marat V', 'Initials': 'MV', 'LastName': 'Ezhov', 'Affiliation': 'National Cardiology Research Center, Moscow, Russia.'}, {'ForeName': 'Derek L', 'Initials': 'DL', 'LastName': 'Connolly', 'Affiliation': 'Birmingham City and Sandwell Hospitals and the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, England.'}, {'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Kalman', 'Initials': 'K', 'LastName': 'Toth', 'Affiliation': 'First Department of Medicine, University of Pecs, Medical School, Pecs, Hungary.'}, {'ForeName': 'Matti J', 'Initials': 'MJ', 'LastName': 'Tikkanen', 'Affiliation': 'Folkhälsan Research Center, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Kyungah', 'Initials': 'K', 'LastName': 'Im', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Masschusetts.""}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Masschusetts.""}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Kurtz', 'Affiliation': 'Amgen, Thousand Oaks, California.'}, {'ForeName': 'Narimon', 'Initials': 'N', 'LastName': 'Honarpour', 'Affiliation': 'Amgen, Thousand Oaks, California.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Masschusetts.""}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Keech', 'Affiliation': 'Sydney Medical School, National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Sever', 'Affiliation': 'Imperial College London, London, England.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Masschusetts.""}]",JAMA cardiology,['10.1001/jamacardio.2019.0886']
888,31028508,Replication of It's Your Game…Keep It Real! in Southeast Texas.,"Despite the recent efforts of the Office of Adolescent Health to replicate programs with demonstrated efficacy, there are still few evidence-based HIV, sexually transmitted infection (STI), and teen pregnancy prevention programs that have been replicated in ""real-world"" settings. To test the effectiveness of It's Your Game…Keep It Real! (IYG), an evidence-based STI and pregnancy prevention program for middle schools, the curriculum was implemented by teachers in urban and suburban middle schools in Southeast Texas from 2012 to 2015. IYG was evaluated using a group-randomized wait-list controlled effectiveness trial design in which 20 middle schools in nine urban and suburban school districts in Southeast Texas were randomized equally, using a multi-attribute randomization protocol, to either the intervention condition (received IYG) (n = 10 schools comprising 1936 eligible seventh graders) or the comparison condition (received usual care) (n = 10 schools comprising 1825 eligible seventh graders). All students were blinded to condition prior to administering the baseline survey. The analytic sample comprised 1543 students (n = 804, intervention; n = 739, comparison) who were followed from baseline (seventh grade) to the 24-month follow-up (ninth grade). Multilevel regression analyses were conducted to assess behavioral and psychosocial outcomes at follow-up. There were no significant differences in initiation of vaginal or oral sex between study conditions at follow-up. However, at 12-month follow-up, compared with students in the comparison condition, students in the intervention condition reported increased knowledge, self-efficacy, and perceived favorable norms related to HIV/STIs, condoms, and/or abstinence; decreased intentions to have sex; and increased intentions to use birth control. Knowledge outcomes were statistically significant at 24-month follow-up. This IYG effectiveness trial did not replicate the behavioral effects of the original IYG efficacy trials. However, it adds to the growing literature on the replication of evidence-based programs, and underscores the need to better understand how variations in implementation, setting, and measurement affect the behavioral impact of such programs.Clinical trial registration clinicaltrials.gov (NCT03533192).",2019,There were no significant differences in initiation of vaginal or oral sex between study conditions at follow-up.,"['20 middle schools in nine urban and suburban school districts in Southeast Texas', 'middle schools, the curriculum was implemented by teachers in urban and suburban middle schools in Southeast Texas from 2012 to 2015', '1543 students (n\u2009=\u2009804, intervention; n\u2009=\u2009739, comparison) who were followed from baseline (seventh grade) to the 24-month follow-up (ninth grade']","[""It's Your Game…"", 'intervention condition (received IYG) (n\u2009=\u200910 schools comprising 1936 eligible seventh graders) or the comparison condition (received usual care']","['knowledge, self-efficacy, and perceived favorable norms related to HIV/STIs, condoms, and/or abstinence; decreased intentions to have sex; and increased intentions to use birth control', 'behavioral and psychosocial outcomes', 'initiation of vaginal or oral sex']","[{'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205441', 'cui_str': 'Seventh (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205443', 'cui_str': 'Ninth (qualifier value)'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205441', 'cui_str': 'Seventh (qualifier value)'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0700589', 'cui_str': 'Fertility Control'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0282348', 'cui_str': 'Oral Sex'}]",1936.0,0.0495006,There were no significant differences in initiation of vaginal or oral sex between study conditions at follow-up.,"[{'ForeName': 'Melissa F', 'Initials': 'MF', 'LastName': 'Peskin', 'Affiliation': 'Center for Health Promotion and Prevention Research, The University of Texas Health Science Center at Houston (UTHealth) School of Public Health, Houston, TX, 77030, USA. Melissa.F.Peskin@uth.tmc.edu.'}, {'ForeName': 'Karin K', 'Initials': 'KK', 'LastName': 'Coyle', 'Affiliation': 'ETR, Scotts Valley, CA, USA.'}, {'ForeName': 'Pamela M', 'Initials': 'PM', 'LastName': 'Anderson', 'Affiliation': 'ETR, Scotts Valley, CA, USA.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Laris', 'Affiliation': 'ETR, Scotts Valley, CA, USA.'}, {'ForeName': 'Jill R', 'Initials': 'JR', 'LastName': 'Glassman', 'Affiliation': 'ETR, Scotts Valley, CA, USA.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Franks', 'Affiliation': 'ETR, Scotts Valley, CA, USA.'}, {'ForeName': 'Melanie A', 'Initials': 'MA', 'LastName': 'Thiel', 'Affiliation': 'University of Texas Medical Branch, Galveston, TX, USA.'}, {'ForeName': 'Susan C', 'Initials': 'SC', 'LastName': 'Potter', 'Affiliation': 'ETR, Scotts Valley, CA, USA.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Unti', 'Affiliation': 'ETR, Scotts Valley, CA, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Edwards', 'Affiliation': 'The Cornerstone Consulting Group, Houston, TX, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Johnson-Baker', 'Affiliation': 'Center for Health Promotion and Prevention Research, The University of Texas Health Science Center at Houston (UTHealth) School of Public Health, Houston, TX, 77030, USA.'}, {'ForeName': 'Paula M', 'Initials': 'PM', 'LastName': 'Cuccaro', 'Affiliation': 'Center for Health Promotion and Prevention Research, The University of Texas Health Science Center at Houston (UTHealth) School of Public Health, Houston, TX, 77030, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Diamond', 'Affiliation': 'Center for Health Promotion and Prevention Research, The University of Texas Health Science Center at Houston (UTHealth) School of Public Health, Houston, TX, 77030, USA.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Markham', 'Affiliation': 'Center for Health Promotion and Prevention Research, The University of Texas Health Science Center at Houston (UTHealth) School of Public Health, Houston, TX, 77030, USA.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Shegog', 'Affiliation': 'Center for Health Promotion and Prevention Research, The University of Texas Health Science Center at Houston (UTHealth) School of Public Health, Houston, TX, 77030, USA.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Baumler', 'Affiliation': 'Center for Health Promotion and Prevention Research, The University of Texas Health Science Center at Houston (UTHealth) School of Public Health, Houston, TX, 77030, USA.'}, {'ForeName': 'Efrat K', 'Initials': 'EK', 'LastName': 'Gabay', 'Affiliation': 'Center for Health Promotion and Prevention Research, The University of Texas Health Science Center at Houston (UTHealth) School of Public Health, Houston, TX, 77030, USA.'}, {'ForeName': 'Susan Tortolero', 'Initials': 'ST', 'LastName': 'Emery', 'Affiliation': 'Center for Health Promotion and Prevention Research, The University of Texas Health Science Center at Houston (UTHealth) School of Public Health, Houston, TX, 77030, USA.'}]",The journal of primary prevention,['10.1007/s10935-019-00549-0']
889,31034032,Risk for Major Hemorrhages in Patients Receiving Clopidogrel and Aspirin Compared With Aspirin Alone After Transient Ischemic Attack or Minor Ischemic Stroke: A Secondary Analysis of the POINT Randomized Clinical Trial.,"Importance


Results show the short-term risk of hemorrhage in treating patients with acute transient ischemic attack (TIA) or minor acute ischemic stroke (AIS) with clopidogrel plus aspirin or aspirin alone.
Objective


To characterize the frequency and kinds of major hemorrhages in the Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) trial.
Design, Setting, and Participants


This secondary analysis of the POINT randomized, double-blind clinical trial conducted in 10 countries in North America, Europe, and Australasia included patients with high-risk TIA or minor AIS who were randomized within 12 hours of symptom onset and followed up for 90 days. The total enrollment, which occurred from May 28, 2010, through December 17, 2017, was 4881 and constituted the intention-to-treat group; 4819 (98.7%) were included in the as-treated analysis group. The primary safety analyses were as-treated, classifying patients based on study drug actually received. Intention-to-treat analyses were performed as secondary analyses. Data were analyzed in April 2018.
Interventions


Patients were assigned to receive clopidogrel (600 mg loading dose on day 1 followed by 75 mg daily for days 2-90) or placebo; all patients also received open-label aspirin, 50 to 325 mg/d.
Main Outcomes and Measures


The primary safety outcome was all major hemorrhages. Other safety outcomes included minor hemorrhages.
Results


A total of 269 sites worldwide randomized 4881 patients (median age, 65.0 years [interquartile range, 55-74 years]; 2195 women [45.0%]); the primary results have been published previously. In the as-treated analyses, major hemorrhage occurred in 21 patients (0.9%) receiving clopidogrel plus aspirin and 6 (0.2%) in the aspirin alone group (hazard ratio, 3.57; 95% CI, 1.44-8.85; P = .003; number needed to harm, 159). There were 4 fatal hemorrhages (0.1%; 3 in the clopidogrel plus aspirin group and 1 in the aspirin alone group); 3 of the 4 were intracranial. There were 7 intracranial hemorrhages (0.1%); 5 were in the clopidogrel plus aspirin group and 2 in the aspirin plus placebo group. The most common location of major hemorrhages was in the gastrointestinal tract.
Conclusions and Relevance


The risk for major hemorrhages in patients receiving either clopidogrel plus aspirin or aspirin alone after TIA or minor AIS was low. Nevertheless, treatment with clopidogrel plus aspirin increased the risk of major hemorrhages over aspirin alone from 0.2% to 0.9%.
Trial Registration


ClinicalTrials.gov identifier: NCT00991029.",2019,The risk for major hemorrhages in patients receiving either clopidogrel plus aspirin or aspirin alone after TIA or minor AIS was low.,"['After Transient Ischemic Attack or Minor Ischemic Stroke', 'patients with acute transient ischemic attack (TIA) or minor acute ischemic stroke (AIS) with', 'A total of 269 sites worldwide randomized 4881 patients (median age, 65.0 years [interquartile range, 55-74 years]; 2195 women [45.0', '10 countries in North America, Europe, and Australasia included patients with high-risk TIA or minor AIS who were randomized within 12 hours of symptom onset and followed up for 90 days']","['clopidogrel plus aspirin or aspirin', 'placebo', 'clopidogrel plus aspirin', 'aspirin', 'open-label aspirin', 'aspirin plus placebo', 'Aspirin Alone', 'Clopidogrel and Aspirin', 'clopidogrel']","['major hemorrhages', 'risk of major hemorrhages', 'intracranial hemorrhages', 'fatal hemorrhages', 'major hemorrhage']","[{'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0282279', 'cui_str': 'Oceania'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}]",4881.0,0.321234,The risk for major hemorrhages in patients receiving either clopidogrel plus aspirin or aspirin alone after TIA or minor AIS was low.,"[{'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Tillman', 'Affiliation': 'Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'S Claiborne', 'Initials': 'SC', 'LastName': 'Johnston', 'Affiliation': ""Dean's Office, Dell Medical School, University of Texas at Austin, Austin.""}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Farrant', 'Affiliation': 'Department of Neurology, University of California, San Francisco, San Francisco.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Barsan', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor.'}, {'ForeName': 'Jordan J', 'Initials': 'JJ', 'LastName': 'Elm', 'Affiliation': 'Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Anthony S', 'Initials': 'AS', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Anne S', 'Initials': 'AS', 'LastName': 'Lindblad', 'Affiliation': 'The Emmes Corporation, Rockville, Maryland.'}, {'ForeName': 'Yuko Y', 'Initials': 'YY', 'LastName': 'Palesch', 'Affiliation': 'Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'J Donald', 'Initials': 'JD', 'LastName': 'Easton', 'Affiliation': 'Department of Neurology, University of California, San Francisco, San Francisco.'}]",JAMA neurology,['10.1001/jamaneurol.2019.0932']
890,31412770,Analgesic effect of the ultrasound-guided subcostal approach to transmuscular quadratus lumborum block in patients undergoing laparoscopic nephrectomy: a randomized controlled trial.,"BACKGROUND


Quadratus lumborum block (QLB) is an effective analgesia that lowers opioid consumption after lower abdominal and hip surgeries. The subcostal approach to transmuscular QLB is a novel technique that can provide postoperative analgesia by blocking more dermatomes. The aim of this study is to evaluate the efficacy and viability of subcostal approach to QLB after laparoscopic nephrectomy.
METHODS


Sixty patients who underwent laparoscopic nephrectomy were randomly divided into the subcostal approach to QLB group (QLB group, n = 30) and the control group (C group, n = 30). All patients underwent ultrasound-guided subcostal approach to QLB in an ipsilateral parasagittal oblique plane at the L1-L2 level. The QLB group received 0.4 cc/kg of 0.3% ropivacaine, and the C group received 0.4 cc/kg of 0.9% saline. Postoperatively, a patient-controlled intravenous analgesic pump with sufentanil was attached to all the patients. The primary outcome was sufentanil consumption within the first 24 h after surgery. The secondary outcomes included the Ramsey sedation scale (RSS) scores and Bruggemann comfort scale (BCS) scores 6 h (T1), 12 h (T2), and 24 h (T3) after surgery, intraoperative remifentanil consumption, number of patients requiring rescue analgesia, time to recovery of intestinal function, mobilization time after surgery, and presence of side effects.
RESULTS


Sufentanil consumption within the first 24 h after surgery was significantly lower in the QLB group than in the C group (mean [standard deviation]: 34.1 [9.9] μg vs 42.1 [11.6] μg, P = .006). The RSS scores did not differ between the two groups, and the BCS scores of the QLB group at T1 and T2 time points was significantly higher than those of the C group(P<0.05). The consumption of remifentanil intraoperatively and the number of patients requiring rescue analgesia were significantly lower in the QLB group (P<0.05). Time to recovery of intestinal function and mobilization time after surgery were significantly earlier in the QLB group (P<0.05). The incidence of postoperative nausea and vomiting was significantly lower in the QLB group (P<0.05).
CONCLUSIONS


The ultrasound-guided subcostal approach to QLB is an effective analgesic technique in patients undergoing laparoscopic nephrectomy as it reduces the consumption of sufentanil postoperatively.
TRIAL REGISTRATION


ChiCTR1800020296 0 (Prospective registered). Initial registration date was 22/12/2018.",2019,Time to recovery of intestinal function and mobilization time after surgery were significantly earlier in the QLB group (P<0.05).,"['Sixty patients who underwent', 'patients undergoing laparoscopic nephrectomy']","['ultrasound-guided subcostal approach to QLB', 'ultrasound-guided subcostal approach to transmuscular quadratus lumborum block', 'laparoscopic nephrectomy', 'QLB', 'Quadratus lumborum block (QLB', 'ropivacaine', 'subcostal approach to QLB group (QLB', 'sufentanil']","['Sufentanil consumption', 'BCS scores', 'Ramsey sedation scale (RSS) scores and Bruggemann comfort scale (BCS) scores 6\u2009h (T1), 12\u2009h (T2), and 24\u2009h (T3) after surgery, intraoperative remifentanil consumption, number of patients requiring rescue analgesia, time to recovery of intestinal function, mobilization time after surgery, and presence of side effects', 'postoperative nausea and vomiting', 'consumption of remifentanil intraoperatively and the number of patients requiring rescue analgesia', 'RSS scores', 'Time to recovery of intestinal function and mobilization time', 'sufentanil consumption within the first 24\u2009h after surgery', 'Analgesic effect']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027695', 'cui_str': 'Nephrectomy'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0442184', 'cui_str': 'Subcostal (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0027695', 'cui_str': 'Nephrectomy'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}]","[{'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C2699011', 'cui_str': 'Really Simple Syndication'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}]",60.0,0.0975016,Time to recovery of intestinal function and mobilization time after surgery were significantly earlier in the QLB group (P<0.05).,"[{'ForeName': 'Manhua', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, Ningbo Medical Center Lihuili Eastern Hospital, Taipei Medical University Ningbo Medical Center, No.1111 jiangnan Road, Ningbo, Zhejiang, 315040, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Qi', 'Affiliation': 'Department of Anesthesiology, Ningbo Medical Center Lihuili Eastern Hospital, Taipei Medical University Ningbo Medical Center, No.1111 jiangnan Road, Ningbo, Zhejiang, 315040, China.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Department of Anesthesiology, Ningbo Medical Center Lihuili Eastern Hospital, Taipei Medical University Ningbo Medical Center, No.1111 jiangnan Road, Ningbo, Zhejiang, 315040, China.'}, {'ForeName': 'Jinfeng', 'Initials': 'J', 'LastName': 'Lou', 'Affiliation': 'Department of Anesthesiology, Ningbo Medical Center Lihuili Eastern Hospital, Taipei Medical University Ningbo Medical Center, No.1111 jiangnan Road, Ningbo, Zhejiang, 315040, China.'}, {'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Pei', 'Affiliation': ""Department of Anesthesiology, Ningbo Beilun People's Hospital, Ningbo, Zhejiang, China, No.1288 lushan east Road, Ningbo, 315800, China.""}, {'ForeName': 'Yuliu', 'Initials': 'Y', 'LastName': 'Mei', 'Affiliation': ""Department of Anesthesiology, Ningbo Beilun People's Hospital, Ningbo, Zhejiang, China, No.1288 lushan east Road, Ningbo, 315800, China. jszhumanhua@hotmail.com.""}]",BMC anesthesiology,['10.1186/s12871-019-0825-4']
891,31470814,"A randomized controlled comparison of non-channeled king vision, McGrath MAC video laryngoscope and Macintosh direct laryngoscope for nasotracheal intubation in patients with predicted difficult intubations.","BACKGROUND


King Vision and McGrath MAC video laryngoscopes (VLs) are increasingly used. The purpose of this study was to evaluate the performance of nasotracheal intubation in patients with predicted difficult intubations using non-channeled King Vision VL, McGrath MAC VL or Macintosh laryngoscope by experienced intubators.
METHODS


Ninety nine ASA I or II adult patients, scheduled for oral maxillofacial surgeries with El-Ganzouri risk index 1-7 were enrolled. Patients were randomly allocated to intubate with one of three laryngoscopes (non-channeled King Vision, McGrath MAC and Macintosh). The intubators were experienced with more than 100 successful nasotracheal intubations using each device. The primary outcome was intubation time. The secondary outcomes included first success rate, time required for viewing the glottis, Cormack-Lehane grade of glottis view, the number of assist maneuvers, hemodynamic responses, the subjective evaluating of sensations of performances and associated complications.
RESULTS


The intubation time of King Vision and McGrath group was comparable (37.6 ± 7.3 s vs. 35.4 ± 8.8 s) and both were shorter than Macintosh group (46.8 ± 10.4 s, p < 0.001). Both King Vision and McGrath groups had a 100% first attempt success rate, significantly higher than Macintosh group (85%, p < 0.05). The laryngoscopy time was comparable between King Vision and McGrath group (16.7 ± 5.5 s vs. 15.6 ± 6.3 s) and was shorter than Macintosh group (22.8 ± 7.2 s, p < 0.05) also. Compared with Macintosh laryngoscope, Glottis view was obviously improved when exposed with either non-channeled King Vision or McGrath MAC VL (p < 0.001), and assist maneuvers required were reduced (p < 0.001). The maximum fluctuations of MAP were significantly attenuated in VL groups (47.7 ± 12.5 mmHg and 45.1 ± 10.3 mmHg vs. 54.9 ± 10.2 mmHg, p < 0.05 and p < 0.01). Most device insertions were graded as excellent in McGrath group, followed by Macintosh and King Vision group (p = 0.0014). The tube advancements were easier in VLs compared with the Macintosh laryngoscope (p < 0.001). Sore throat was found more frequent in Macintosh group compared with King Vision group (p < 0.05).
CONCLUSIONS


Non-channeled King Vision and McGrath MAC VLs were comparable and both devices facilitated nasotracheal intubation in managing predicted difficult intubations compared with Macintosh laryngoscope.
TRIAL REGISTRATION


ClinicalTrials registration number NCT03126344 . Registered on April 24, 2017.",2019,"Sore throat was found more frequent in Macintosh group compared with King Vision group (p < 0.05).
","['patients with predicted difficult intubations using non-channeled King Vision VL, McGrath MAC VL or Macintosh laryngoscope by experienced intubators', 'patients with predicted difficult intubations', 'Ninety nine ASA I or II adult patients, scheduled for oral maxillofacial surgeries with El-Ganzouri risk index 1-7 were enrolled']","['non-channeled king vision, McGrath MAC video laryngoscope and Macintosh direct laryngoscope', 'King Vision', 'three laryngoscopes (non-channeled King Vision, McGrath MAC and Macintosh']","['success rate, time required for viewing the glottis, Cormack-Lehane grade of glottis view, the number of assist maneuvers, hemodynamic responses, the subjective evaluating of sensations of performances and associated complications', 'intubation time', 'maximum fluctuations of MAP', 'success rate', 'intubation time of King Vision', 'Sore throat', 'laryngoscopy time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0549401', 'cui_str': 'Difficult airway intubation'}, {'cui': 'C0439799', 'cui_str': 'Channel (qualifier value)'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0009545', 'cui_str': 'C5b-9'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscopes'}, {'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0038908', 'cui_str': 'Surgery, Maxillofacial'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0303134', 'cui_str': '7Be radioisotope'}]","[{'cui': 'C0439799', 'cui_str': 'Channel (qualifier value)'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0009545', 'cui_str': 'C5b-9'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscopes'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure (body structure)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0242429', 'cui_str': 'Sore Throat'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}]",99.0,0.0615393,"Sore throat was found more frequent in Macintosh group compared with King Vision group (p < 0.05).
","[{'ForeName': 'Haozhen', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': ""Department of Anesthesiology, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 639 Zhizaoju Road, Shanghai, 200011, China.""}, {'ForeName': 'Jinxing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Anesthesiology, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 639 Zhizaoju Road, Shanghai, 200011, China.""}, {'ForeName': 'Lulu', 'Initials': 'L', 'LastName': 'Suo', 'Affiliation': ""Department of Anesthesiology, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 639 Zhizaoju Road, Shanghai, 200011, China.""}, {'ForeName': 'Chi', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': ""Department of Anesthesiology, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 639 Zhizaoju Road, Shanghai, 200011, China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': ""Department of Anesthesiology, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 639 Zhizaoju Road, Shanghai, 200011, China. dr_sunyu@163.com.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': ""Department of Anesthesiology, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 639 Zhizaoju Road, Shanghai, 200011, China. dr_jianghong@163.com.""}]",BMC anesthesiology,['10.1186/s12871-019-0838-z']
892,31472669,Magnesium sulfate reduces the rocuronium dose needed for satisfactory double lumen tube placement conditions in patients with myasthenia gravis.,"BACKGROUND


Using a minimum dose of neuromuscular blockade (NMB) to achieve intubation condition is one of the goals in anaesthesia management of patients with myasthenia gravis (MG) for thoracoscopic (VATS) thymectomy. However, tracheal intubation with double lumen tube (DLT) could be challenging if intubation condition is not optimal. This double-blind randomised controlled study was designed to investigate whether magnesium sulfate would reduce the rocuronium dose needed for DLT intubation and improve the DLT placement condition for patients with MG who were scheduled for video-assisted thoracoscopic (VATS) thymectomy.
METHODS


Recruited patients were randomly assigned to receive magnesium sulfate 60 mg.kg - 1  or normal saline (control) prior to the administration of NMB. Titrating dose of rocuronium was administered to achieve train of four (TOF) ratio less than 10% before DLT intubation. The primary outcome was the rocuronium dose required to achieve TOF ratio less than 10%. The secondary outcome was intubation condition for DLT placement.
RESULTS


Twenty-three patients had received magnesium sulfate and 22 patients had received normal saline before rocuronium administration. The required rocuronium dose [mean (standard deviation)] were 0.10 (0.05) mg.kg - 1  and 0.28(0.17) mg.kg - 1  in patients who had magnesium sulfate and normal saline respectively(P < 0.0001). With a similar depth of neuromuscular blockade and depth of anaesthesia, 100% of patients in the magnesium sulfate group and 72.7% of patients in the control group showed excellent intubation condition (P = 0.027) respectively. The patients in both groups had similar emergence characteristics.
CONCLUSIONS


Magnesium sulfate is associated with a decrease in rocuronium requirement for an optimal DLT intubation condition in patients with MG for VATS thymectomy.
TRIAL REGISTRATION


Clinical Trial Registry of China ( http://www.chictr.org.cn ) identifier: ChiCTR-1800017696, retrospectively registered on August 10, 2018.",2019,mg.kg - 1  in patients who had magnesium sulfate and normal saline respectively(P < 0.0001).,"['Recruited patients', 'patients with myasthenia gravis (MG) for thoracoscopic (VATS) thymectomy', 'patients with MG for VATS thymectomy', 'patients with myasthenia gravis', 'patients with MG who were scheduled for video-assisted thoracoscopic (VATS) thymectomy']","['rocuronium', 'magnesium sulfate', 'magnesium sulfate 60\u2009mg.kg -\u20091  or normal saline (control) prior to the administration of NMB', 'neuromuscular blockade (NMB', 'tracheal intubation with double lumen tube (DLT', 'normal saline', 'Magnesium sulfate']","['intubation condition for DLT placement', 'rocuronium dose required to achieve TOF ratio less', 'excellent intubation condition']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia Gravis'}, {'cui': 'C2945605', 'cui_str': 'Total thymectomy (procedure)'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}]","[{'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0235062', 'cui_str': 'Neuromuscular Block'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}]",,0.764217,mg.kg - 1  in patients who had magnesium sulfate and normal saline respectively(P < 0.0001).,"[{'ForeName': 'Shoujun', 'Initials': 'S', 'LastName': 'Fei', 'Affiliation': 'Department of Anaesthesiology, The University of Hong Kong - Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Hengfu', 'Initials': 'H', 'LastName': 'Xia', 'Affiliation': 'Department of Anaesthesiology, The University of Hong Kong - Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Anaesthesiology, The University of Hong Kong - Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Dazhi', 'Initials': 'D', 'LastName': 'Pang', 'Affiliation': 'Department of Thoracic surgery, The University of Hong Kong - Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Xuebing', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Anaesthesiology, The University of Hong Kong - Shenzhen Hospital, Shenzhen, China. xuxuebing@hotmail.com.'}]",BMC anesthesiology,['10.1186/s12871-019-0841-4']
893,30788692,Mobile App-Based Small-Group Physical Activity Intervention for Young African American Women: a Pilot Randomized Controlled Trial.,"A lack of adequate physical activity among young African American women remains a serious public health challenge. Few evidence-based interventions are available to increase physical activity in this population, and none has leveraged mobile technologies, even though African Americans are among the most avid users of mobile applications (apps). We conducted a pilot randomized controlled trial to test the efficacy of a mobile app-based small-group intervention in increasing physical activity among African American women aged 18 to 35 years (N = 91) in Philadelphia, PA. Cohorts of eight participants were randomized in a 1:1 ratio to a 4-women small-group intervention or an individual control condition. Control participants used the app to track their own activities. Small-group participants could track their own activities and those of the other three women in their group and could message the other women using a chatting tool. The primary outcome was meeting the goal of engaging in at least 90 min/day of light physical activity during the 3-month study period objectively assessed by a Fitbit device. Data were collected in 2016 and analyzed in 2017. Group participants had higher odds of meeting the goal (OR = 1.48, p = .048) than did control participants, an effect that did not wane during the 3-month study period. Irrespective of condition, participants had lower body-mass index (p = .01) and performed more push-ups (p < .0001) at the 1-month and 3-month assessments compared with the baseline measures. Mobile apps facilitating small online groups can contribute to efforts to increase physical activity among young African American women.This study is registered at www.clinicaltrials.gov NCT02736903.",2019,"Irrespective of condition, participants had lower body-mass index (p = .01) and performed more push-ups (p < .0001) at the 1-month and 3-month assessments compared with the baseline measures.","['young African American women', 'Young African American Women', 'African American women aged 18 to 35\xa0years (N\u2009=\u200991) in Philadelphia, PA']","['Mobile App-Based Small-Group Physical Activity Intervention', 'mobile app-based small-group intervention', '4-women small-group intervention or an individual control condition']","['goal of engaging in at least 90\xa0min/day of light physical activity', 'physical activity', 'lower body-mass index']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0556973', 'cui_str': 'mins/day'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1268088', 'cui_str': 'Lower body'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",8.0,0.10203,"Irrespective of condition, participants had lower body-mass index (p = .01) and performed more push-ups (p < .0001) at the 1-month and 3-month assessments compared with the baseline measures.","[{'ForeName': 'Jingwen', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Communication, University of California, Davis, One Shields Avenue, Davis, CA, 95616, USA. jwzzhang@ucdavis.edu.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Jemmott Iii', 'Affiliation': 'Perelman School of Medicine and Annenberg School for Communication, University of Pennsylvania, 3901 Walnut Street, Suite 500, Philadelphia, PA, 19104, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-019-01006-4']
894,32077514,Comparison of acupuncture on specific and non-specific points for the treatment of painful temporomandibular disorders: A randomised controlled trial.,"BACKGROUND AND OBJECTIVE


The aim of this single-centre, two-arm, parallel-group, double-blinded, randomised controlled trial was to investigate the disputed specific effectiveness of acupuncture by comparing acupuncture on specific and non-specific points among patients with non-chronic, painful TMDs.
METHODS


Following predefined eligibility criteria, 49 consecutive patients of both sexes were recruited to the study. All subjects were diagnosed with a non-chronic (Graded Chronic Pain Scale grade <3) painful TMD, as assessed using the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). Patients were randomly assigned to group A (acupuncture on specific points) or group B (acupuncture on non-specific points) after the initial examination (T0). Both acupuncture treatment sessions were conducted by a trained dentist once a week for four weeks. The examination was repeated five weeks (T5) after T0 by one calibrated examiner who was unaware of the study groups. Characteristic pain intensity (CPI) was evaluated as the main outcome criterion and compared between times and treatment groups by means of non-parametric tests (significance level set at P = .05). Secondary outcomes comprised the maximum corrected active mouth-opening without pain (MAO); patients' expectations regarding acupuncture treatment and pain development; depressivity; and oral health-related quality of life (OHRQoL).
RESULTS


A total of 41 patients (38 female) successfully completed the study (mean age: 40.17 ± 16.61). The two groups did not differ significantly at any time in terms of age and CPI. However, CPI was significantly (P < .05) lower at T5 than at T0 for both groups (29.66 and 30.35% lower in group A and group B, respectively). An increase in MAO was observed at T5 for both groups but was significant for group B only (P = .016). All patients had positive expectations of acupuncture therapy, and the two groups did not differ significantly at T5 with regard to the extent to which their expectations had been fulfilled by the treatment (P = .717). Comparison of T0 and T5 showed a statistically significant reduction of depressivity for group A (P = .0205), but no significant change for group B (P = .329). At T5, OHRQoL had improved significantly for both groups (group A, P = .018; group B, P < .001) compared with at T0.
CONCLUSIONS


Acupuncture on both specific and non-specific points reduces the non-dysfunctional pain of TMD patients. The effect of acupuncture on painful TMD cannot be attributed to the specific point selection.",2020,"At T5, OHRQoL had improved significantly for both groups (group A, p=0.018; group B, p<0.001) compared with at T0.
","['Following predefined eligibility criteria, 49 consecutive patients of both sexes were recruited to the study', 'All subjects were diagnosed with a non-chronic (Graded Chronic Pain Scale grade<3) painful TMD, as assessed using the Diagnostic Criteria for Temporomandibular Disorders', 'painful temporomandibular disorders', '41 patients (38 female) successfully completed the study (mean age: 40.17 ±16.61', 'patients with non-chronic, painful TMDs']","['acupuncture', 'Acupuncture', 'acupuncture on specific points) or group B (acupuncture on non-specific points']","['CPI', 'Characteristic pain intensity (CPI', ""maximum corrected active mouth-opening without pain (MAO); patients' expectations regarding acupuncture treatment and pain development; depressivity; and oral-health-related quality of life (OHRQoL"", 'MAO']","[{'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0039494', 'cui_str': 'TMJ Diseases'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}]","[{'cui': 'C0130753', 'cui_str': 'calpain inhibitor 2'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture Treatment'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0029162'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0026454', 'cui_str': 'MAO'}]",49.0,0.168132,"At T5, OHRQoL had improved significantly for both groups (group A, p=0.018; group B, p<0.001) compared with at T0.
","[{'ForeName': 'Sinan', 'Initials': 'S', 'LastName': 'Şen', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Gül', 'Initials': 'G', 'LastName': 'Orhan', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Sertel', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Schmitter', 'Affiliation': 'Department of Prosthodontics, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Schindler', 'Affiliation': 'Department of Prosthodontics, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Lux', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Nikolaos Nikitas', 'Initials': 'NN', 'LastName': 'Giannakopoulos', 'Affiliation': 'Department of Prosthodontics, University of Würzburg, Würzburg, Germany.'}]",Journal of oral rehabilitation,['10.1111/joor.12952']
895,32097051,"Relationship between Symptoms, Exacerbations, and Treatment Response in Bronchiectasis.","Rationale:  Bronchiectasis guidelines regard treatment to prevent exacerbation and treatment of daily symptoms as separate objectives. Objectives:  We hypothesized that patients with greater symptoms would be at higher risk of exacerbations and therefore that a treatment aimed at reducing daily symptoms would also reduce exacerbations in highly symptomatic patients. Methods:  Our study comprised an observational cohort of 333 patients from the East of Scotland (2012-2016). Either symptoms were modeled as a continuous variable or patients were classified as having high, moderate, or low symptom burden (>70, 40-70, and <40 using the St. George's Respiratory Questionnaire symptom score). The hypothesis that exacerbation reductions would only be evident in highly symptomatic patients was tested in a  post hoc  analysis of a randomized trial of inhaled dry powder mannitol ( N  = 461 patients). Measurements and Main Results:  In the observational cohort, daily symptoms were a significant predictor of future exacerbations (rate ratio [RR], 1.10; 95% confidence interval [CI], 1.03-1.17;  P  = 0.005). Patients with higher symptom scores had higher exacerbation rates (RR, 1.74; 95% CI, 1.12-2.72;  P  = 0.01) over 12-month follow-up than those with lower symptoms. Inhaled mannitol treatment improved the time to first exacerbation (hazard ratio, 0.56; 95% CI, 0.40-0.77;  P  < 0.001), and the proportion of patients remaining exacerbation free for 12 months of treatment was higher in the mannitol group (32.7% vs. 14.6%; RR, 2.84; 95% CI, 1.40-5.76;  P  = 0.003), but only in highly symptomatic patients. In contrast, no benefit was evident in patients with lower symptom burden. Conclusions:  Highly symptomatic patients have increased risk of exacerbations, and exacerbation benefit with inhaled mannitol was only evident in patients with high symptom burden.",2020,"Patients with high symptom scores had higher exacerbation rates (RR 1.74, 95% CI 1.12-2.72,P=0.01) over 12 months follow-up compared to those with lower symptoms.","['N=461 patients) Measurement and Main Results', '333 patients from the East of Scotland(2012-2016', 'patients with greater symptoms']","['inhaled mannitol', 'Inhaled mannitol']","['risk of exacerbations, and exacerbation benefit', 'proportion of patients remaining exacerbation free', 'exacerbation rates', 'time to first exacerbation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4517724', 'cui_str': 'Three hundred and thirty-three'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0887166', 'cui_str': '(L)-Mannitol'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",333.0,0.663845,"Patients with high symptom scores had higher exacerbation rates (RR 1.74, 95% CI 1.12-2.72,P=0.01) over 12 months follow-up compared to those with lower symptoms.","[{'ForeName': 'Yong-Hua', 'Initials': 'YH', 'LastName': 'Gao', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Abo Leyah', 'Affiliation': 'Scottish Centre for Respiratory Medicine, University of Dundee, Dundee, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Finch', 'Affiliation': 'Scottish Centre for Respiratory Medicine, University of Dundee, Dundee, United Kingdom.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Lonergan', 'Affiliation': 'Scottish Centre for Respiratory Medicine, University of Dundee, Dundee, United Kingdom.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Aliberti', 'Affiliation': 'Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'De Soyza', 'Affiliation': 'Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, United Kingdom; and.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Fardon', 'Affiliation': 'Scottish Centre for Respiratory Medicine, University of Dundee, Dundee, United Kingdom.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Tino', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Chalmers', 'Affiliation': 'Scottish Centre for Respiratory Medicine, University of Dundee, Dundee, United Kingdom.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201910-1972OC']
896,31141497,Effect of chronic nitrate and citrulline supplementation on vascular function and exercise performance in older individuals.,"Increased nitric oxide (NO) bioavailability may improve exercise performance and vascular function. It remains unclear whether older adults who experience a decreased NO bioavailability may benefit from chronic NO precursor supplementation. This randomised, double-blind, trial aims to assess the effect of chronic NO precursor intake on vascular function and exercise performance in older adults (60-70 years old). Twenty-four healthy older adults (12 females) performed vascular function assessment and both local (knee extensions) and whole-body (incremental cycling) exercise tests to exhaustion before and after one month of daily intake of a placebo (PLA) or a nitrate-rich salad and citrulline (N+C, 520mg nitrate and 6g citrulline) drink. Arterial blood pressure (BP) and stiffness, post-ischemic, hypercapnic and hypoxic vascular responses were evaluated. Prefrontal cortex and quadriceps oxygenation was monitored by near-infrared spectroscopy. N+C supplementation reduced mean BP (-3.3mmHg; p=0.047) without altering other parameters of vascular function and oxygenation kinetics. N+C supplementation reduced heart rate and oxygen consumption during submaximal cycling and increased maximal power output by 5.2% (p<0.05), but had no effect on knee extension exercise performance. These results suggest that chronic NO precursor supplementation in healthy older individuals can reduce resting BP and increase cycling performance by improving cardiorespiratory responses.",2019,N+C supplementation reduced mean BP (-3.3mmHg; p=0.047) without altering other parameters of vascular function and oxygenation kinetics.,"['healthy older individuals', 'older individuals', 'Twenty-four healthy older adults (12 females) performed', 'older adults (60-70 years old']","['chronic NO precursor intake', 'vascular function assessment and both local (knee extensions) and whole-body (incremental cycling) exercise tests to exhaustion before and after one month of daily intake of a placebo (PLA) or a nitrate-rich salad and citrulline (N+C, 520mg nitrate and 6g citrulline) drink', 'chronic nitrate and citrulline supplementation', 'N+C supplementation']","['Arterial blood pressure (BP) and stiffness, post-ischemic, hypercapnic and hypoxic vascular responses', 'Increased nitric oxide (NO) bioavailability', 'Prefrontal cortex and quadriceps oxygenation', 'maximal power output', 'vascular function and exercise performance', 'knee extension exercise performance', 'resting BP and increase cycling performance', 'exercise performance and vascular function', 'mean BP', 'vascular function and oxygenation kinetics', 'heart rate and oxygen consumption']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C4082115', 'cui_str': 'One month (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0453740', 'cui_str': 'Salad (substance)'}, {'cui': 'C0008864', 'cui_str': 'Citrulline'}, {'cui': 'C4517803', 'cui_str': '520 (qualifier value)'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}]","[{'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}]",24.0,0.185106,N+C supplementation reduced mean BP (-3.3mmHg; p=0.047) without altering other parameters of vascular function and oxygenation kinetics.,"[{'ForeName': 'Thibault', 'Initials': 'T', 'LastName': 'Le Roux-Mallouf', 'Affiliation': 'Université Grenoble Alpes, Inserm, HP2 Laboratory, F-38000, Grenoble, France.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Pelen', 'Affiliation': 'Université Grenoble Alpes, Inserm, HP2 Laboratory, F-38000, Grenoble, France.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Vallejo', 'Affiliation': 'Université Grenoble Alpes, Inserm, HP2 Laboratory, F-38000, Grenoble, France.'}, {'ForeName': 'Idir', 'Initials': 'I', 'LastName': 'Halimaoui', 'Affiliation': 'Université Grenoble Alpes, Inserm, HP2 Laboratory, F-38000, Grenoble, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Doutreleau', 'Affiliation': 'Université Grenoble Alpes, Inserm, HP2 Laboratory, F-38000, Grenoble, France.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Verges', 'Affiliation': 'Université Grenoble Alpes, Inserm, HP2 Laboratory, F-38000, Grenoble, France.'}]",Aging,['10.18632/aging.101984']
897,32162204,TrimetaziDine as a Performance-enhancING drug in heart failure with preserved ejection fraction (DoPING-HFpEF): rationale and design of a placebo-controlled cross-over intervention study.,"BACKGROUND


Currently, no specific treatment exists for heart failure with preserved ejection fraction (HFpEF). Left ventricular (LV) relaxation during diastole is a highly energy-demanding process, while energy homeostasis is known to be compromised in HFpEF. We hypothesise that trimetazidine - a fatty acid β‑oxidation inhibitor - improves LV diastolic function in HFpEF, by altering myocardial substrate use and improving the myocardial energy status.
OBJECTIVES


To assess whether trimetazidine improves LV diastolic function by improving myocardial energy metabolism in HFpEF.
METHODS


The DoPING-HFpEF trial is a randomised, double-blind, placebo-controlled cross-over intervention trial comparing the efficacy of trimetazidine and placebo in 25 patients with stable HFpEF. The main inclusion criteria are: New York Heart Association functional class II to IV, LV ejection fraction ≥50%, and evidence of LV diastolic dysfunction. Patients are treated with one 20-mg trimetazidine tablet or placebo thrice daily (twice daily in the case of moderate renal dysfunction) for two periods of 3 months separated by a 2-week washout period. The primary endpoint is the change in pulmonary capillary wedge pressure during different intensities of exercise measured by right heart catheterisation. Our key secondary endpoint is the myocardial phosphocreatine (PCr)/ATP ratio measured by phosphorus-31 magnetic resonance spectroscopy and its relation to the primary endpoint. Exploratory endpoints are 6‑min walk distance, N-terminal pro-brain natriuretic peptide levels, and quality of life.
CONCLUSION


The DoPING-HFpEF is a phase-II trial that evaluates the effect of trimetazidine, a metabolic modulator, on diastolic function and myocardial energy status in HFpEF. [EU Clinical Trial Register: 2018-002170-52; NTR registration: NL7830].",2020,"The DoPING-HFpEF trial is a randomised, double-blind, placebo-controlled cross-over intervention trial comparing the efficacy of trimetazidine and placebo in 25 patients with stable HFpEF.","['heart failure with preserved ejection fraction (DoPING-HFpEF', '25\xa0patients with stable HFpEF']","['trimetazidine -\xa0a\xa0fatty acid β‑oxidation inhibitor ', 'placebo', 'TrimetaziDine', 'trimetazidine and placebo', 'trimetazidine', 'trimetazidine tablet or placebo']","['myocardial phosphocreatine (PCr)/ATP ratio', '6‑min walk distance, N-terminal pro-brain natriuretic peptide levels, and quality of life', 'LV diastolic function', 'change in pulmonary capillary wedge pressure during different intensities of exercise measured by right heart catheterisation']","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}]","[{'cui': 'C0041037', 'cui_str': 'Trimetazidine'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0031634', 'cui_str': 'Phosphorylcreatine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C1533071', 'cui_str': 'N-terminal pro-brain natriuretic peptide measurement'}, {'cui': 'C0034380'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0086879', 'cui_str': 'Pulmonary Capillary Wedge Pressure'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0189896', 'cui_str': 'Catheterization of right heart (procedure)'}]",,0.228946,"The DoPING-HFpEF trial is a randomised, double-blind, placebo-controlled cross-over intervention trial comparing the efficacy of trimetazidine and placebo in 25 patients with stable HFpEF.","[{'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'van de Bovenkamp', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Bakermans', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'C P', 'Initials': 'CP', 'LastName': 'Allaart', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Nederveen', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'W E M', 'Initials': 'WEM', 'LastName': 'Kok', 'Affiliation': 'Department of Clinical and Experimental Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, Heart Center, Amsterdam, The Netherlands.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'van Rossum', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Handoko', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands. ml.handoko@amsterdamumc.nl.'}]",Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation,['10.1007/s12471-020-01407-z']
898,32142529,Continuous wound infiltration versus epidural analgesia for midline abdominal incisions - a randomized-controlled pilot trial (Painless-Pilot trial; DRKS Number: DRKS00008023).,"OBJECTIVES


To test the feasibility of a randomized controlled study design comparing epidural analgesia (EDA) with continuous wound infiltration (CWI) in respect to postoperative complications and mobility to design a future multicentre randomized controlled trial.
DESIGN, SETTING, PARTICIPANTS


CWI has been developed to address drawbacks of EDA. Previous studies have established the equivalent analgesic potential of CWI compared to EDA. This is a single centre, non-blinded pilot randomized controlled trial at a tertiary surgical centre. Patients undergoing elective non-colorectal surgery via a midline laparotomy were randomized to EDA or CWI. Endpoints included recruitment, feasibility of assessing postoperative mobility with a pedometer and morbidity. No primary endpoint was defined and all analyses were explorative.
INTERVENTIONS


CWI with local anaesthetics (experimental group) vs. thoracic EDA (control).
RESULTS


Of 846 patients screened within 14 months, 71 were randomized and 62 (31 per group) included in the intention-to-treat analysis. Mobility was assessed in 44 of 62 patients and revealed no differences within the first 3 postoperative days. Overall morbidity did not differ between the two groups (measured via the comprehensive complication index). Median pain scores at rest were comparable between the two groups, while EDA was superior in pain treatment during movement on the first, but not on the second and third postoperative day. Duration of preoperative induction of anaesthesia was shorter with CWI than with EDA. Of 17 serious adverse events, 3 were potentially related to EDA, while none was related to CWI.
CONCLUSION


This trial confirmed the feasibility of a randomized trial design to compare CWI and EDA regarding morbidity. Improvements in the education and training of team members are necessary to improve recruitment.
TRIAL REGISTRATION


DRKS00008023.",2020,"Median pain scores at rest were comparable between the two groups, while EDA was superior in pain treatment during movement on the first, but not on the second and third postoperative day.","['Patients undergoing elective non-colorectal surgery via a midline laparotomy', '846 patients screened within 14 months, 71 were randomized and 62 (31 per group) included in the intention-to-treat analysis']","['Continuous wound infiltration versus epidural analgesia', 'CWI with local anaesthetics (experimental group) vs. thoracic EDA (control', 'EDA or CWI', 'epidural analgesia (EDA) with continuous wound infiltration (CWI']","['Median pain scores', 'Overall morbidity', 'recruitment, feasibility of assessing postoperative mobility with a pedometer and morbidity', 'Mobility', 'Duration of preoperative induction of anaesthesia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0009369', 'cui_str': 'Colon and Rectal Surgery Specialty'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0394871', 'cui_str': 'Wound infiltration (procedure)'}, {'cui': 'C0002769', 'cui_str': 'Analgesia, Epidural'}, {'cui': 'C0002934', 'cui_str': 'Conduction-Blocking Anesthetics'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0853212', 'cui_str': 'Induction of anesthesia'}]",71.0,0.157879,"Median pain scores at rest were comparable between the two groups, while EDA was superior in pain treatment during movement on the first, but not on the second and third postoperative day.","[{'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Klotz', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Svenja E', 'Initials': 'SE', 'LastName': 'Seide', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Knebel', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Probst', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bruckner', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Motsch', 'Affiliation': 'Department of Anaesthesiology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hyhlik-Dürr', 'Affiliation': 'Department of Vascular and Endovascular Surgery, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Dittmar', 'Initials': 'D', 'LastName': 'Böckler', 'Affiliation': 'Department of Vascular and Endovascular Surgery, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Larmann', 'Affiliation': 'Department of Anaesthesiology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Markus K', 'Initials': 'MK', 'LastName': 'Diener', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Markus A', 'Initials': 'MA', 'LastName': 'Weigand', 'Affiliation': 'Department of Anaesthesiology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Büchler', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Andre L', 'Initials': 'AL', 'LastName': 'Mihaljevic', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University Hospital Heidelberg, Heidelberg, Germany.'}]",PloS one,['10.1371/journal.pone.0229898']
899,31915235,Seven-day vonoprazan and low-dose amoxicillin dual therapy as first-line  Helicobacter pylori  treatment: a multicentre randomised trial in Japan.,"OBJECTIVE


To date, no randomised trials have compared the efficacy of vonoprazan and amoxicillin dual therapy with other standard regimens for  Helicobacter pylori  treatment. This study aimed to investigate the efficacy of the 7-day vonoprazan and low-dose amoxicillin dual therapy as a first-line  H. pylori  treatment, and compared this with vonoprazan-based triple therapy.
DESIGN


This prospective, randomised clinical trial was performed at seven Japanese institutions. Patients with  H. pylori -positive culture test and naive to treatment were randomly assigned in a 1:1 ratio to either VA-dual therapy (vonoprazan 20 mg+amoxicillin 750 mg twice/day) or VAC-triple therapy (vonoprazan 20 mg+amoxicillin 750 mg+clarithromycin 200 mg twice/day) for 7 days, with stratification by age, sex,  H. pylori  antimicrobial resistance and institution. Eradication success was evaluated by  13 C-urea breath test at least 4 weeks after treatment.
RESULTS


Between October 2018 and June 2019, 629 subjects were screened and 335 were randomised. The eradication rates of VA-dual and VAC-triple therapies were 84.5% and 89.2% (p=0.203) by intention-to-treat analysis, respectively, and 87.1% and 90.2% (p=0.372) by per-protocol analysis, respectively. VA-dual was non-inferior to VAC-triple in the per-protocol analysis. The eradication rates in strains resistant to clarithromycin for VA-dual were significantly higher than those for VAC-triple (92.3% vs 76.2%; p=0.048). The incidence of adverse events was equal between groups.
CONCLUSION


The 7-day vonoprazan and low-dose amoxicillin dual therapy provided acceptable  H. pylori  eradication rates and a similar effect to vonoprazan-based triple therapy in regions with high clarithromycin resistance.
TRIAL REGISTRATION NUMBER


UMIN000034140.",2020,The eradication rates in strains resistant to clarithromycin for VA-dual were significantly higher than those for VAC-triple (92.3% vs 76.2%; p=0.048).,"['Patients with  H. pylori -positive culture test and naive to treatment', 'Between October 2018 and June 2019, 629 subjects were screened and 335 were randomised', 'Helicobacter pylori  treatment', 'seven Japanese institutions']","['VA-dual therapy (vonoprazan 20\u2009mg+amoxicillin 750\u2009mg twice/day) or VAC-triple therapy (vonoprazan 20\u2009mg+amoxicillin 750\u2009mg+clarithromycin', 'clarithromycin', 'amoxicillin dual therapy', '7-day vonoprazan and low-dose amoxicillin dual therapy', 'vonoprazan and amoxicillin dual therapy', 'vonoprazan-based triple therapy']","['eradication rates of VA-dual and VAC-triple therapies', 'Eradication success', 'adverse events', 'eradication rates', 'acceptable  H. pylori  eradication rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4080009', 'cui_str': 'Vonoprazan'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}]",629.0,0.110318,The eradication rates in strains resistant to clarithromycin for VA-dual were significantly higher than those for VAC-triple (92.3% vs 76.2%; p=0.048).,"[{'ForeName': 'Sho', 'Initials': 'S', 'LastName': 'Suzuki', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Gotoda', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan takujigotoda@yahoo.co.jp.'}, {'ForeName': 'Chika', 'Initials': 'C', 'LastName': 'Kusano', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hisatomo', 'Initials': 'H', 'LastName': 'Ikehara', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Ryoji', 'Initials': 'R', 'LastName': 'Ichijima', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Motoki', 'Initials': 'M', 'LastName': 'Ohyauchi', 'Affiliation': 'Department of Gastroenterology, Osaki Citizen Hospital, Osaki, Miyagi, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Ito', 'Affiliation': 'Department of Gastroenterology, Osaki Citizen Hospital, Osaki, Miyagi, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Kawamura', 'Affiliation': 'Department of Gastroenterology, Sendai City Hospital, Sendai, Miyagi, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Ogata', 'Affiliation': 'Department of Gastroenterology, Sendai City Hospital, Sendai, Miyagi, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Ohtaka', 'Affiliation': 'Yamanashi Koseiren Health Care Center, Kofu, Yamanashi, Japan.'}, {'ForeName': 'Moriyasu', 'Initials': 'M', 'LastName': 'Nakahara', 'Affiliation': 'Department of Gastroenterology, Chichibu Municipal Hospital, Chichibu, Saitama, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Kawabe', 'Affiliation': 'Department of Gastroenterology, Fukaya Red Cross Hospital, Fukaya, Saitama, Japan.'}]",Gut,['10.1136/gutjnl-2019-319954']
900,31213447,"Multicentre, open-label, randomised, controlled clinical trial comparing 2% chlorhexidine-70% isopropanol and 5% povidone iodine-69% ethanol for skin antisepsis in reducing surgical-site infection after cardiac surgery: the CLEAN 2 study protocol.","INTRODUCTION


Surgical-site infection (SSI) is the second most frequent cause of healthcare-associated infection worldwide and is associated with increased morbidity, mortality and healthcare costs. Cardiac surgery is clean surgery with low incidence of SSI, ranging from 2% to 5%, but with potentially severe consequences.Perioperative skin antisepsis with an alcohol-based antiseptic solution is recommended to prevent SSI, but the superiority of chlorhexidine (CHG)-alcohol over povidone iodine (PVI)-alcohol, the two most common alcohol-based antiseptic solutions used worldwide, is controversial. We aim to evaluate whether 2% CHG-70% isopropanol is more effective than 5% PVI-69% ethanol in reducing the incidence of reoperation after cardiac surgery.
METHODS AND ANALYSIS


The CLEAN 2 study is a multicentre, open-label, randomised, controlled clinical trial of 4100 patients undergoing cardiac surgery. Patients will be randomised in 1:1 ratio to receive either 2% CHG-70% isopropanol or 5% PVI-69% ethanol for perioperative skin preparation. The primary endpoint is the proportion of patients undergoing any re-sternotomy between day 0 and day 90 after initial surgery and/or any reoperation on saphenous vein/radial artery surgical site between day 0 and day 30 after initial surgery. Data will be analysed on the intention-to-treat principle.
ETHICS AND DISSEMINATION


This protocol has been approved by an independent ethics committee and will be carried out according to the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. The results of this study will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


EudraCT 2017-005169-33 and NCT03560193.",2019,The primary endpoint is the proportion of patients undergoing any re-sternotomy between day 0 and day 90 after initial surgery and/or any reoperation on saphenous vein/radial artery surgical site between day 0 and day 30 after initial surgery.,"['4100 patients undergoing cardiac surgery', 'surgical-site infection after cardiac surgery']","['PVI-69% ethanol', 'alcohol-based antiseptic solution', '2% CHG-70% isopropanol or 5% PVI-69% ethanol', 'CHG-70% isopropanol', 'chlorhexidine (CHG)-alcohol over povidone iodine (PVI)-alcohol', 'chlorhexidine-70% isopropanol and 5% povidone iodine-69% ethanol']",['proportion of patients undergoing any re-sternotomy between day 0 and day 90 after initial surgery and/or any reoperation on saphenous vein/radial artery surgical site'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}]","[{'cui': 'C0202304', 'cui_str': 'Alcohol measurement (procedure)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3540796', 'cui_str': 'Antiseptic throat preparations'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C1527601', 'cui_str': '(alphaMe)Chg'}, {'cui': 'C0524161', 'cui_str': 'Isopropanol measurement (procedure)'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0185792', 'cui_str': 'Sternotomy'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0036186', 'cui_str': 'Saphenous Vein'}, {'cui': 'C0162857', 'cui_str': 'Radial Artery'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]",4100.0,0.144868,The primary endpoint is the proportion of patients undergoing any re-sternotomy between day 0 and day 90 after initial surgery and/or any reoperation on saphenous vein/radial artery surgical site between day 0 and day 30 after initial surgery.,"[{'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Boisson', 'Affiliation': 'Anaesthesia and Intensive Care Unit, Centre Hospitalier Universitaire de Poitiers, Poitiers, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Corbi', 'Affiliation': 'Cardiothoracic Surgery Unit, Centre Hospitalier Universitaire de Poitiers, Poitiers, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kerforne', 'Affiliation': 'Anaesthesia and Intensive Care Unit, Centre Hospitalier Universitaire de Poitiers, Poitiers, France.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Camilleri', 'Affiliation': 'Cardiothoracic Surgery Unit, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Debauchez', 'Affiliation': 'Cardiothoracic Surgery Unit, Institut Mutualiste Montsouris, Paris, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Demondion', 'Affiliation': 'Cardiothoracic Surgery Unit, Hopitaux Universitaires Pitie Salpetriere-Charles Foix, Paris, France.'}, {'ForeName': 'Vedat', 'Initials': 'V', 'LastName': 'Eljezi', 'Affiliation': 'Anaesthesia and Intensive Care Unit, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Erwan', 'Initials': 'E', 'LastName': 'Flecher', 'Affiliation': 'Cardiothoracic Surgery Unit, Centre Hospitalier Universitaire de Rennes, Rennes, France.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Lepelletier', 'Affiliation': 'Infection Control Unit, Centre Hospitalier Universitaire de Nantes, Nantes, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Leprince', 'Affiliation': 'Cardiothoracic Surgery Unit, Hopitaux Universitaires Pitie Salpetriere-Charles Foix, Paris, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Nesseler', 'Affiliation': 'Anaesthesia and Intensive Care Unit, Centre Hospitalier Universitaire de Rennes, Rennes, France.'}, {'ForeName': 'Jacques Yves', 'Initials': 'JY', 'LastName': 'Nizou', 'Affiliation': 'Infection Control Unit, Institut Mutualiste Montsouris, Paris, France.'}, {'ForeName': 'Jean Christian', 'Initials': 'JC', 'LastName': 'Roussel', 'Affiliation': 'Cardiothoracic Surgery Unit, Centre Hospitalier Universitaire de Nantes, Nantes, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Rozec', 'Affiliation': 'Anesthesia and Intensive Care Unit, Centre Hospitalier Universitaire de Nantes, Nantes, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Ruckly', 'Affiliation': 'INSERM UMR 1137, Universite Paris Diderot UFR de Medecine Site Xavier-Bichat, Paris, France.'}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Lucet', 'Affiliation': 'Infection Control Unit, Hopital Bichat - Claude-Bernard, Paris, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Timsit', 'Affiliation': 'INSERM UMR 1137, Universite Paris Diderot UFR de Medecine Site Xavier-Bichat, Paris, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Mimoz', 'Affiliation': 'INSERM U1070, Universite de Poitiers UFR Medecine et Pharmacie, Poitiers, France.'}]",BMJ open,['10.1136/bmjopen-2018-026929']
901,31067138,"Local Consolidative Therapy Vs. Maintenance Therapy or Observation for Patients With Oligometastatic Non-Small-Cell Lung Cancer: Long-Term Results of a Multi-Institutional, Phase II, Randomized Study.","PURPOSE


Our previously published findings reported that local consolidative therapy (LCT) with radiotherapy or surgery improved progression-free survival (PFS) and delayed new disease in patients with oligometastatic non-small-cell lung cancer (NSCLC) that did not progress after front-line systemic therapy. Herein, we present the longer-term overall survival (OS) results accompanied by additional secondary end points.
PATIENTS AND METHODS


This multicenter, randomized, phase II trial enrolled patients with stage IV NSCLC, three or fewer metastases, and no progression at 3 or more months after front-line systemic therapy. Patients were randomly assigned (1:1) to maintenance therapy or observation (MT/O) or to LCT to all active disease sites. The primary end point was PFS; secondary end points were OS, toxicity, and the appearance of new lesions. All analyses were two sided, and  P  values less than .10 were deemed significant.
RESULTS


The Data Safety and Monitoring Board recommended early trial closure after 49 patients were randomly assigned because of a significant PFS benefit in the LCT arm. With an updated median follow-up time of 38.8 months (range, 28.3 to 61.4 months), the PFS benefit was durable (median, 14.2 months [95% CI, 7.4 to 23.1 months] with LCT  v  4.4 months [95% CI, 2.2 to 8.3 months] with MT/O;  P  = .022). We also found an OS benefit in the LCT arm (median, 41.2 months [95% CI, 18.9 months to not reached] with LCT  v  17.0 months [95% CI, 10.1 to 39.8 months] with MT/O;  P  = .017). No additional grade 3 or greater toxicities were observed. Survival after progression was longer in the LCT group (37.6 months with LCT  v  9.4 months with MT/O;  P  = .034). Of the 20 patients who experienced progression in the MT/O arm, nine received LCT to all lesions after progression, and the median OS was 17 months (95% CI, 7.8 months to not reached).
CONCLUSION


In patients with oligometastatic NSCLC that did not progress after front-line systemic therapy, LCT prolonged PFS and OS relative to MT/O.",2019,Survival after progression was longer in the LCT group (37.6 months with LCT  v  9.4 months with MT/O;  P  = .034).,"['patients with oligometastatic non-small-cell lung cancer (NSCLC', '49 patients', 'Patients With Oligometastatic Non-Small-Cell Lung Cancer', 'enrolled patients with stage IV NSCLC, three or fewer metastases, and no progression at 3 or more months after front-line systemic therapy']","['maintenance therapy or observation (MT/O) or to LCT', 'LCT', 'Maintenance Therapy or Observation', 'local consolidative therapy (LCT) with radiotherapy']","['OS benefit', 'Survival after progression', 'progression-free survival (PFS', 'OS, toxicity, and the appearance of new lesions', 'longer-term overall survival (OS', 'median OS', 'PFS benefit', 'toxicities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",49.0,0.136817,Survival after progression was longer in the LCT group (37.6 months with LCT  v  9.4 months with MT/O;  P  = .034).,"[{'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Gomez', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Blumenschein', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Hernandez', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'J Jack', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Ye', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Palma', 'Affiliation': '2 London Health Sciences Center, London, Ontario, Canada.'}, {'ForeName': 'Alexander V', 'Initials': 'AV', 'LastName': 'Louie', 'Affiliation': '2 London Health Sciences Center, London, Ontario, Canada.'}, {'ForeName': 'D Ross', 'Initials': 'DR', 'LastName': 'Camidge', 'Affiliation': '3 University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Doebele', 'Affiliation': '3 University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Ferdinandos', 'Initials': 'F', 'LastName': 'Skoulidis', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Laurie E', 'Initials': 'LE', 'LastName': 'Gaspar', 'Affiliation': '3 University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Welsh', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Don L', 'Initials': 'DL', 'LastName': 'Gibbons', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Karam', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Kavanagh', 'Affiliation': '3 University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Anne S', 'Initials': 'AS', 'LastName': 'Tsao', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Sepesi', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Swisher', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'John V', 'Initials': 'JV', 'LastName': 'Heymach', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00201']
902,31069128,"Phase 2, randomized, open-label study on catheter-directed thrombolysis with plasmin versus rtPA and placebo in acute peripheral arterial occlusion.","Background:  Patients with acute peripheral arterial occlusion (aPAO) are candidates for operative thrombectomy, bypass, or catheter-directed thrombolysis (CDT) using a plasminogen activator. Human plasma-derived plasmin may offer another CDT option.  Objectives:  To evaluate the efficacy, safety, and tolerability of two intrathrombus delivery methods and two doses of plasmin compared with recombinant tissue plasminogen activator (rtPA) and placebo in patients with aPAO.  Patients/methods:  This was a phase 2, randomized, open-label study of intra-arterial CDT of plasmin in patients with aPAO. The study used infusion catheters with or without balloon occlusion (BOC) to evaluate 150 mg plasmin (2 and 5 h post-infusion) and 250 mg plasmin (5 h post-infusion). The efficacy of plasmin, rtPA and placebo was assessed.  Results:  One hundred and seventy-four subjects were enrolled. Overall, the thrombolytic efficacy (>50% thrombolysis) was 59% (58/99) for 150 mg plasmin without BOC, which is comparable to 89% (8/9) for rtPA without BOC ( p  = 0.149) and 40% (2/5) for placebo control ( p =  0.648). The thrombolytic efficacy was 33% of the 250 mg plasmin group. There was no difference ( p  > 0.999) in thrombolytic efficacy with BOC (59%, 58/99) or without BOC (59%, 17/29). Plasmin-treated groups experienced treatment-emergent adverse events (TEAEs) at 71% (76/107) without BOC and 63% (24/38) with BOC; 78% (7/9) of the rtPA-treated group and 89% (8/9) of the placebo group had TEAEs. Serious AEs (SAEs) occurred in 29% (31/107) of the 150 mg plasmin group without BOC and 24% (9/38) with BOC. No SAEs occurred in the 250 mg plasmin group.  Conclusions:  Plasmin demonstrated less bleeding during catheter-directed administration at 150 mg and 250 mg doses compared to rtPA. BOC utilization did not improve efficacy. CDT with plasmin has a potential thrombolytic benefit in patients presenting with aPAO.  ClinicalTrials.gov Identifier:  NCT01222117.",2019,"There was no difference ( p  > 0.999) in thrombolytic efficacy with BOC (59%, 58/99) or without BOC (59%, 17/29).","['Patients with acute peripheral arterial occlusion (aPAO', 'One hundred and seventy-four subjects were enrolled', 'acute peripheral arterial occlusion', 'patients presenting with aPAO', 'patients with aPAO']","['placebo', 'plasmin, rtPA and placebo', 'Plasmin', 'recombinant tissue plasminogen activator (rtPA) and placebo', 'plasmin versus rtPA and placebo', 'CDT with plasmin', 'plasmin', 'infusion catheters with or without balloon occlusion (BOC) to evaluate 150\u2009mg plasmin (2 and 5\u2009h post-infusion) and 250\u2009mg plasmin']","['bleeding', 'efficacy, safety, and tolerability', 'BOC utilization', 'thrombolytic efficacy', 'thrombolytic efficacy with BOC', 'efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0264995', 'cui_str': 'Occlusion of artery (disorder)'}, {'cui': 'C0642476', 'cui_str': 'APAO'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0016016', 'cui_str': 'fibrinolysin'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0887842', 'cui_str': 'Balloon Occlusion'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C2348831', 'cui_str': '250'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0016018', 'cui_str': 'Fibrinolytic Drugs'}]",174.0,0.0759527,"There was no difference ( p  > 0.999) in thrombolytic efficacy with BOC (59%, 58/99) or without BOC (59%, 17/29).","[{'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Comerota', 'Affiliation': 'Medical Director Eastern Region, Inova Heart and Vascular Institute, Inova Alexandria Hospital, Alexandria, VA, USA.'}, {'ForeName': 'Lazar', 'Initials': 'L', 'LastName': 'Davidovic', 'Affiliation': 'Faculty of Medicine, University of Belgrade, Clinic for Vascular and Endovascular Surgery, Serbian Clinical Center, Belgrade, Serbia.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hanna', 'Affiliation': 'Department of Clinical Development, Grifols Inc, Research Triangle Park, NC, USA.'}, {'ForeName': 'Kecia L', 'Initials': 'KL', 'LastName': 'Courtney', 'Affiliation': 'Department of Clinical Development, Grifols Inc, Research Triangle Park, NC, USA.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Shlansky-Goldberg', 'Affiliation': 'Department of Radiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}]",Journal of drug assessment,['10.1080/21556660.2019.1586402']
903,31438849,"Impact of brief prewarming on anesthesia-related core-temperature drop, hemodynamics, microperfusion and postoperative ventilation in cytoreductive surgery of ovarian cancer: a randomized trial.","BACKGROUND


General (GA)- and epidural-anesthesia may cause a drop in body-core-temperature (BCT drop ), and hypothermia, which may alter tissue oxygenation (StO 2 ) and microperfusion after cytoreductive surgery for ovarian cancer. Cell metabolism of subcutaneous fat- or skeletal muscle cells, measured in microdialysis, may be affected. We hypothesized that forced-air prewarming during epidural catheter placement and induction of GA maintains normothermia and improves microperfusion.
METHODS


After ethics approval 47 women scheduled for cytoreductive surgery were prospectively enrolled. Women in the study group were treated with a prewarming of 43 °C during epidural catheter placement. BCT (Spot on®, 3 M) was measured before (T 1 ), after induction of GA (T 2 ) at 15 min (T 3 ) after start of surgery, and until 2 h after ICU admission (T ICU2h ). Primary endpoint was BCT drop  between T 1  and T 2 . Microperfusion-, hemodynamic- and clinical outcomes were defined as secondary outcomes. Statistical analysis used the Mann-Whitney-U- and non-parametric-longitudinal tests.
RESULTS


BCT drop  was 0.35 °C with prewarming and 0.9 °C without prewarming (p < 0.005) and BCT remained higher over the observation period (ΔT 4  = 0.9 °C up to ΔT 7  = 0.95 °C, p < 0.001). No significant differences in hemodynamic parameters, transfusion, arterial lactate and dCO 2  were measured. In microdialysis the ethanol ratio was temporarily, but not significantly, reduced after prewarming. Lactate, glucose and glycerol after PW tended to be more constant over the entire period. Postoperatively, six women without prewarming, but none after prewarming were mechanical ventilated (p < 0.001).
CONCLUSION


Prewarming at 43 °C reduces the BCT drop  and maintains normothermia without impeding the perioperative routine patient flow. Microdialysis indicate better preserved parameters of microperfusion.
TRIAL REGISTRATION


ClinicalTrials.gov ; ID: NCT02364219 ; Date of registration: 18-febr-2015.",2019,Prewarming at 43 °C reduces the BCT drop  and maintains normothermia without impeding the perioperative routine patient flow.,"['47 women scheduled for cytoreductive surgery were prospectively enrolled', 'cytoreductive surgery of ovarian cancer']","['General (GA)- and epidural-anesthesia', 'epidural catheter placement', 'brief prewarming on anesthesia-related core-temperature drop, hemodynamics, microperfusion and postoperative ventilation']","['Lactate, glucose and glycerol after PW', 'BCT', 'BCT drop  between T 1  and T 2 ', 'hemodynamic parameters, transfusion, arterial lactate and dCO 2']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive Surgery'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}, {'cui': 'C3665866', 'cui_str': 'Epidural catheter placement'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}]","[{'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}]",47.0,0.245025,Prewarming at 43 °C reduces the BCT drop  and maintains normothermia without impeding the perioperative routine patient flow.,"[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Kaufner', 'Affiliation': 'Department of Anaesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Virchow-Klinikum, Augustenburger Platz 1, 13353, Berlin, Germany. lutz.kaufner@charite.de.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Niggemann', 'Affiliation': 'Department of Anaesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Virchow-Klinikum, Augustenburger Platz 1, 13353, Berlin, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Baum', 'Affiliation': 'Department of Anaesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Virchow-Klinikum, Augustenburger Platz 1, 13353, Berlin, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Casu', 'Affiliation': 'Department of Anaesthesia, Intensive Care Medicine, Emergency Medicine and Pain Therapy, Vivantes Klinikum im Friedrichshain, Berlin, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sehouli', 'Affiliation': 'Department of Gynaecology, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bietenbeck', 'Affiliation': 'Institut für Klinische Chemie und Pathobiochemie, Klinikum rechts der Isar der Technischen Universität München, Munich, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Boschmann', 'Affiliation': 'Experimental & Clinical Research Center, ECRC, Charité-Universitätsmedizin Berlin CCB, Berlin, Germany.'}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Spies', 'Affiliation': 'Department of Anaesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Virchow-Klinikum, Augustenburger Platz 1, 13353, Berlin, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Henkelmann', 'Affiliation': 'Department of Anaesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Virchow-Klinikum, Augustenburger Platz 1, 13353, Berlin, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'von Heymann', 'Affiliation': 'Department of Anaesthesia, Intensive Care Medicine, Emergency Medicine and Pain Therapy, Vivantes Klinikum im Friedrichshain, Berlin, Germany.'}]",BMC anesthesiology,['10.1186/s12871-019-0828-1']
904,30741103,The efficacy of the modified Story Memory Technique in progressive MS.,"BACKGROUND


Impairments in new learning and memory are common in individuals with multiple sclerosis (MS), negatively impacting everyday life, including occupational and social functioning.
OBJECTIVE


This study examined the efficacy of the modified Story Memory Technique (mSMT) in a progressive multiple sclerosis (PMS) sample through a double-blind, placebo-controlled, randomized clinical trial (RCT).
METHODS


Thirty (30) individuals with PMS, naïve to the mSMT, were randomized to the treatment or placebo control group.  The Treatment Group  completed mSMT training twice per week for 5 weeks while the  Placebo Group  met with the therapist at the same frequency, engaging in non-training-oriented tasks to control for professional contact and disease alterations.
RESULTS


The treatment group showed significant improvements in learning compared with the placebo control group, evident on both objective evaluation of new learning and self-report of functioning in daily life. Increased awareness of cognitive deficits was also noted post-treatment.
CONCLUSION


These data provide Class I evidence supporting the efficacy of the mSMT in PMS. A behavioral intervention, targeted to specifically strengthen new learning, can significantly improve memory performance in PMS, and this improvement in memory performance is maintained 3 months later.",2020,"The treatment group showed significant improvements in learning compared with the placebo control group, evident on both objective evaluation of new learning and self-report of functioning in daily life.","['individuals with multiple sclerosis (MS', 'individuals with PMS, naïve to the mSMT', '\n\n\nThirty (30', 'progressive MS']","['modified Story Memory Technique', 'placebo', 'modified Story Memory Technique (mSMT', 'Placebo', 'mSMT training']","['Increased awareness of cognitive deficits', 'objective evaluation of new learning and self-report of functioning in daily life', 'learning', 'memory performance']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0033046', 'cui_str': 'PMS - Premenstrual syndrome'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1285654', 'cui_str': 'Ability to remember'}]",,0.0471112,"The treatment group showed significant improvements in learning compared with the placebo control group, evident on both objective evaluation of new learning and self-report of functioning in daily life.","[{'ForeName': 'Nancy D', 'Initials': 'ND', 'LastName': 'Chiaravalloti', 'Affiliation': 'Neuropsychology and Neuroscience Laboratory, Kessler Foundation, West Orange, NJ, USA; Department of Physical Medicine and Rehabilitation, Rutgers New Jersey Medical School, Newark, NJ, USA; Neuropsychology and Neuroscience Laboratory, Kessler Foundation, East Hanover, NJ, USA.'}, {'ForeName': 'Nancy B', 'Initials': 'NB', 'LastName': 'Moore', 'Affiliation': 'Neuropsychology and Neuroscience Laboratory, Kessler Foundation, West Orange, NJ, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'DeLuca', 'Affiliation': 'Neuropsychology and Neuroscience Laboratory, Kessler Foundation, West Orange, NJ, USA; Department of Physical Medicine and Rehabilitation, Rutgers New Jersey Medical School, Newark, NJ, USA; Department of Neurology, Rutgers New Jersey Medical School, Newark, NJ, USA.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458519826463']
905,32057131,Imaginator: A Proof-of-Concept Feasibility Trial of a Brief Imagery-Based Psychological Intervention for Young People Who Self-Harm.,"OBJECTIVES


The Imaginator study tested the feasibility of a short mental imagery-based psychological intervention for young people who self-harm and used a stepped-wedge design to investigate effects on self-harm frequency reduction at 3 and 6 months.
METHOD


A total of 38 participants aged 16-25 were recruited via community self-referral and mental health services. Participants were randomized to immediate delivery of Functional Imagery Training (FIT) or usual care followed by delayed delivery after 3 months. FIT comprised two face-to-face sessions, five phone sessions, and use of a smartphone app. Outcomes' assessment was blind to allocation.
RESULTS


Three quarters of those who began treatment completed face-to-face sessions, and 57% completed five or more sessions in total. Self-harm frequency data were obtained on 76% of the sample at 3 months (primary outcome) and 63% at 6 months. FIT produced moderate reductions in self-harm frequency at 3 months after immediate (d = 0.65) and delayed delivery (d = 0.75). The Immediate FIT group maintained improvements from 3 to 6 months (d = 0.05). Participants receiving usual care also reduced self-harm (d = 0.47).
CONCLUSIONS


A brief mental imagery-based psychological intervention targeting self-harm in young people is feasible and may comprise a novel transdiagnostic treatment for self-harm.",2020,FIT produced moderate reductions in self-harm frequency at 3 months after immediate (d = 0.65) and delayed delivery (d = 0.75).,"['young people', 'Young People', 'Participants receiving usual care also reduced self-harm (d\xa0=\xa00.47', '38 participants aged 16-25 were recruited via community self-referral and mental health services', 'Imaginator', 'young people who self-harm']","['mental imagery-based psychological intervention', 'Brief Imagery-Based Psychological Intervention', 'short mental imagery-based psychological intervention', 'Functional Imagery Training (FIT) or usual care followed by delayed delivery after 3\xa0months']",[],"[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0085271', 'cui_str': 'Self-Injury'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0237824', 'cui_str': 'Self-referral (procedure)'}, {'cui': 'C0025355', 'cui_str': 'Mental Hygiene Services'}]","[{'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0235863', 'cui_str': 'Delayed delivery'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",[],38.0,0.0348264,FIT produced moderate reductions in self-harm frequency at 3 months after immediate (d = 0.65) and delayed delivery (d = 0.75).,"[{'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Di Simplicio', 'Affiliation': 'Division of Psychiatry, Department of Brain Sciences, Imperial College London, London, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Appiah-Kusi', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King's College London, London, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Wilkinson', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Watson', 'Affiliation': 'MRC Cognition and Brain Sciences Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Meiser-Stedman', 'Affiliation': 'Cambridgeshire and Peterborough NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Kavanagh', 'Affiliation': ""Centre for Children's Health Research, School of Psychology & Counselling, Institute of Health & Biomedical Innovation, Queensland University of Technology, Brisbane, QLD, Australia.""}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Holmes', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}]",Suicide & life-threatening behavior,['10.1111/sltb.12620']
906,30637672,Recanting of Previous Reports of Alcohol Consumption within a Large-Scale Clustered Randomised Control Trial.,"The aim of this study was to examine the extent of recanting (inconsistencies in reporting of lifetime alcohol use) and its impact on the assessment of primary outcomes within a large-scale alcohol prevention trial. One hundred and five post-primary schools in were randomised to receive either the intervention or education as normal. Participants (N = 12,738) were secondary school students in year 8/S1 (mean age 12.5) at baseline. Self-report questionnaires were administered at baseline (T0) and at T1 (+ 12 months post-baseline), T2 (+ 24 months) and T3 (+ 33 months). The primary outcomes were (i) heavy episodic drinking (consumption of ≥ 6 units in a single episode in the previous 30 days for males and ≥ 4.5 units for females) assessed at T3 and (ii) the number of alcohol-related harms experienced in the last 6 months assessed at T3. Recanting was defined as a negative report of lifetime alcohol consumption that contradicted a prior positive report. Between T1 and T3, 9.9% of students recanted earlier alcohol consumption. Recanting ranged from 4.5 to 5.3% across individual data sweeps. While recanting was significantly associated (negatively) with both primary outcomes, the difference in the rate of recanting across trial arms was small, and adjusting for recanting within the primary outcome models did not impact on the primary outcome effects. Males were observed to recant at a greater rate than females, with a borderline small-sized effect (V = .09). While differential rates of recanting have the potential to undermine the analysis of prevention trial outcomes, recanting is easy to identify and control for within trial primary outcome analyses. Adjusting for recanting should be considered as an additional sensitivity test within prevention trials.Trial Registration: ISRCTN47028486 ( http://www.isrctn.com/ISRCTN47028486 ). The date of trial registration was 23/09/2011, and school recruitment began 01/11/2011.",2019,"While recanting was significantly associated (negatively) with both primary outcomes, the difference in the rate of recanting across trial arms was small, and adjusting for recanting within the primary outcome models did not impact on the primary outcome effects.","['Participants (N\u2009=\u200912,738) were secondary school students in year', 'One hundred and five post-primary schools']",[],['heavy episodic drinking (consumption of ≥'],"[{'cui': 'C0036530', 'cui_str': 'Schools, Secondary'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}]",[],"[{'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",12738.0,0.201413,"While recanting was significantly associated (negatively) with both primary outcomes, the difference in the rate of recanting across trial arms was small, and adjusting for recanting within the primary outcome models did not impact on the primary outcome effects.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Percy', 'Affiliation': ""Centre for Evidence and Social Innovation, School of Social Sciences, Education and Social Work, Queen's University Belfast, Belfast, UK. a.percy@qub.ac.uk.""}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Agus', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Cole', 'Affiliation': 'University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Doherty', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Foxcroft', 'Affiliation': 'Oxford Brookes University, Oxford, UK.'}, {'ForeName': 'Séamus', 'Initials': 'S', 'LastName': 'Harvey', 'Affiliation': 'Bangor University, Bangor, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McKay', 'Affiliation': 'University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Murphy', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast, UK.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Sumnall', 'Affiliation': 'Liverpool John Moores University, Liverpool, UK.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-019-0981-2']
907,31980506,Zinc acetate lozenges for the treatment of the common cold: a randomised controlled trial.,"OBJECTIVE


To examine a commercially available zinc acetate lozenge for treating the common cold.
DESIGN


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


Working population in Finland.
PARTICIPANTS


We included men and women aged ≥18 years who usually had ≥1 cold per winter. Exclusions were pregnancy, lactation, chronic runny nose or chronic cough.
INTERVENTION


We randomised 253 participants to receive a package of lozenges to be taken if they caught the common cold. Of the 253 participants, 88 contracted the common cold and 87 were included in our primary analysis. Zinc acetate lozenges contained 13 mg elemental zinc and placebo lozenges contained sucrose octa-acetate to camouflage the taste of zinc. Instruction to use was six times per day for the maximum of 5 days.
PRIMARY OUTCOME


Rate of recovery from the common cold analysed by Cox regression.
RESULTS


There was no difference in the recovery rate between zinc and placebo participants during the 10-day follow-up (rate ratio for zinc vs placebo=0.68, 95% CI 0.42 to 1.08; p=0.10). The recovery rate for the two groups was similar during the 5-day intervention, but for 2 days after the end of zinc/placebo use, the zinc participants recovered significantly slower compared with the placebo participants (p=0.003). In the zinc group, 37% did not report adverse effects, the corresponding proportion being 69% in the placebo group.
CONCLUSIONS


A commercially available zinc acetate lozenge was not effective in treating the common cold when instructed to be used for 5 days after the first symptoms. Taste has been a common problem in previous zinc lozenge trials, but a third of zinc participants did not complain of any adverse effects. More research is needed to evaluate the characteristics of zinc lozenges that may be clinically efficacious before zinc lozenges can be widely promoted for common cold treatment.
TRIAL REGISTRATION NUMBER


NCT03309995.",2020,"The recovery rate for the two groups was similar during the 5-day intervention, but for 2 days after the end of zinc/placebo use, the zinc participants recovered significantly slower compared with the placebo participants (p=0.003).","['Working population in Finland', '253 participants to receive a', '253 participants, 88 contracted the common cold and 87 were included in our primary analysis', 'We included men and women aged ≥18 years who usually had ≥1\u2009cold per winter']","['package of lozenges', 'placebo', 'Zinc acetate lozenges']","['recovery rate', 'Rate of recovery from the common cold analysed by Cox regression', 'adverse effects', 'pregnancy, lactation, chronic runny nose or chronic cough']","[{'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C1704764', 'cui_str': 'Per'}]","[{'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C4319836', 'cui_str': 'Lozenge'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0149368', 'cui_str': 'Zinc Acetate'}]","[{'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0442996', 'cui_str': 'Cox (qualifier value)'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0022925', 'cui_str': 'Milk Secretion'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1260880', 'cui_str': 'Nasal catarrh'}, {'cui': 'C0010201', 'cui_str': 'Chronic cough (finding)'}]",253.0,0.797897,"The recovery rate for the two groups was similar during the 5-day intervention, but for 2 days after the end of zinc/placebo use, the zinc participants recovered significantly slower compared with the placebo participants (p=0.003).","[{'ForeName': 'Harri', 'Initials': 'H', 'LastName': 'Hemilä', 'Affiliation': 'Department of Public Health, University of Helsinki, Helsinki, Finland harri.hemila@helsinki.fi.'}, {'ForeName': 'Jari', 'Initials': 'J', 'LastName': 'Haukka', 'Affiliation': 'Department of Public Health, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Alho', 'Affiliation': 'Espoo City Occupational Health Services, Espoo, Finland.'}, {'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Vahtera', 'Affiliation': 'Department of Public Health, University of Turku, Turku, Finland.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Kivimäki', 'Affiliation': 'Centre of Expertise for Work Organizations, Finnish Institute of Occupational Health, Helsinki, Finland.'}]",BMJ open,['10.1136/bmjopen-2019-031662']
908,32020660,Cardiovascular effects of brief mindfulness meditation among perfectionists experiencing failure.,"Research links perfectionism, the tendency to hold and pursue unrealistically high standards, to negative mental health outcomes such as eating disorders, anxiety, and depression. Previous research used high frequency heart rate variability (HF-HRV) to measure recovery from stress during a mindfulness meditation in perfectionistic university students and found that only nonperfectionists demonstrated HF-HRV recovery from stress, suggesting that mindfulness was not effective for perfectionists. However, the mindfulness meditation did not incorporate a nonjudgment element, which may be a key component for perfectionists. In the current study, we examined whether mindfulness with a focus on nonjudgment helps university student perfectionists (n = 120) recover from failure (measured by heart rate (HR), HF-HRV, pNN50). Students were randomly assigned to one of four meditation groups: nonjudgment mindfulness, general mindfulness (i.e., attentional awareness without a nonjudgment component), progressive muscle relaxation, and nothing. Cardiac data were recorded during a 5-min baseline, failure task, and 10-min meditation session. HR results suggest that both mindfulness conditions and ""nothing"" encouraged cardiovascular recovery, but that the mindfulness conditions showed even further recovery during the last five minutes of the meditations. HF-HRV results indicated that participants in the nonjudgment mindfulness condition had marginally higher HF-HRV during the last five minutes of the meditation than at baseline, while participants in the other conditions did not. Therefore, mindfulness with a focus on nonjudgment of emotions may be especially important to help perfectionists improve HF-HRV after failure.",2020,"HF-HRV results indicated that participants in the nonjudgment mindfulness condition had marginally higher HF-HRV during the last five minutes of the meditation than at baseline, while participants in the other conditions did not.","['perfectionistic university students', 'perfectionists experiencing failure']","['brief mindfulness meditation', 'nonjudgment mindfulness, general mindfulness (i.e., attentional awareness without a nonjudgment component), progressive muscle relaxation, and nothing']","['heart rate (HR), HF-HRV, pNN50', 'HF-HRV']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0150277'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0004361', 'cui_str': 'Progressive Relaxation'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",,0.0163339,"HF-HRV results indicated that participants in the nonjudgment mindfulness condition had marginally higher HF-HRV during the last five minutes of the meditation than at baseline, while participants in the other conditions did not.","[{'ForeName': 'Hannah R', 'Initials': 'HR', 'LastName': 'Koerten', 'Affiliation': 'Psychology Department, Bowling Green State University, Bowling Green, OH, USA.'}, {'ForeName': 'Tanya S', 'Initials': 'TS', 'LastName': 'Watford', 'Affiliation': 'Psychology Department, Bowling Green State University, Bowling Green, OH, USA.'}, {'ForeName': 'Eric F', 'Initials': 'EF', 'LastName': 'Dubow', 'Affiliation': 'Psychology Department, Bowling Green State University, Bowling Green, OH, USA.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': ""O'Brien"", 'Affiliation': 'Psychology Department, Bowling Green State University, Bowling Green, OH, USA.'}]",Psychophysiology,['10.1111/psyp.13517']
909,31402432,Photobiomodulation therapy and NMES improve muscle strength and jumping performance in young volleyball athletes: a randomized controlled trial study in Brazil.,"The purpose of this study was to investigate the effectiveness of adding photobiomodulation therapy and neuromuscular electrical stimulation (NMES) to volleyball athletes' training, focusing on muscle strength and jumping skills. Thirty-six athletes were randomly placed into three groups: control, photobiomodulation therapy, and NMES. The athletes trained to improve their muscle strength and jumping skills. The athletes in the photobiomodulation therapy group were submitted to photobiomodulation therapy (850 nm, continuous, energy density 0.8 J/cm 2 , radiant energy per point 6 J, total radiant energy 36 J) before undergoing strength and plyometric training. The NMES group additionally underwent NMES-based quadriceps femoris muscle strength training (base frequency 1 kHz, frequency modulation 70 Hz, intensity maximum tolerable). The variables analyzed were muscle strength, jumping ability, global impression, and jump frequency; they were measured at baseline and during follow-ups at 6 and 8 weeks. The statistical analysis was conducted on an intention-to-treat basis. The between-group differences and their respective 95% CIs were calculated using linear mixed models by using group, time, and group-versus-time interaction terms. Dominant lower limb strength improved the most in the NMES group compared to the control group (mean difference = 1.4, 95% CI = .5 to 2.4). Non-dominant lower limb strength increased in both the photobiomodulation therapy group (mean difference = 1.1, 95% CI = .3 to 2) and the NMES group (mean difference = 1.9, 95% CI = 1.1 to 2.8) compared to the control group, but the NMES group improved more than the photobiomodulation therapy group (mean difference = 0.8, 95% CI = 0.1 to 1.7). The NMES group had the greatest improvement in global perceived effect scale compared to the control group (mean difference = 1.1, 95% CI = 1 to 2.2). Dominant lower limb strength improved in the NMES group compared to the control group. Non-dominant lower limb strength increased in both the photobiomodulation therapy group and the NMES group compared to the control group, but the NMES group improved significantly more than the photobiomodulation therapy group; the NMES group also improved in the global perceived effect scale compared to the control group. This study found that, for volleyball athletes, photobiomodulation therapy and NMES both promoted benefits in terms of muscle-strength gain. In addition, these benefits were maintained for 2 weeks even after training was interrupted. Dominant lower limb strength improved in the NMES group compared to the control group. Non-dominant lower limb strength increased in both the photobiomodulation therapy group and the NMES group compared to the control group, but the NMES group improved significantly more than the photobiomodulation therapy group; the NMES group also improved in global impression of jumps compared to the control group.",2020,"Non-dominant lower limb strength increased in both the photobiomodulation therapy group (mean difference = 1.1, 95% CI = .3 to 2) and the NMES group (mean difference = 1.9, 95% CI = 1.1 to 2.8) compared to the control group, but the NMES group improved more than the photobiomodulation therapy group (mean difference = 0.8, 95% CI = 0.1 to 1.7).","['volleyball athletes', 'young volleyball athletes', 'Thirty-six athletes']","['control, photobiomodulation therapy, and NMES', 'NMES-based quadriceps femoris muscle strength training', 'photobiomodulation therapy and neuromuscular electrical stimulation (NMES', 'photobiomodulation therapy', 'NMES', 'Photobiomodulation therapy and NMES']","['limb strength', 'muscle strength, jumping ability, global impression, and jump frequency', 'global impression of jumps', 'muscle strength and jumping performance', 'Hz, intensity maximum tolerable', 'global perceived effect scale']","[{'cui': 'C1956059', 'cui_str': 'Volleyball'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4019433', 'cui_str': 'LLLT'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}]","[{'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0222045'}]",,0.0383293,"Non-dominant lower limb strength increased in both the photobiomodulation therapy group (mean difference = 1.1, 95% CI = .3 to 2) and the NMES group (mean difference = 1.9, 95% CI = 1.1 to 2.8) compared to the control group, but the NMES group improved more than the photobiomodulation therapy group (mean difference = 0.8, 95% CI = 0.1 to 1.7).","[{'ForeName': 'Ronaldo Alves', 'Initials': 'RA', 'LastName': 'da Cunha', 'Affiliation': 'Departamento de Ortopedia e Traumatologia, Programa de Pós-Graduação em Ciências da Saúde Aplicada ao Esporte e à Atividade Física, Universidade Federal de São Paulo, São Paulo, Brazil. ronaldoalvesdacunha@yahoo.com.br.'}, {'ForeName': 'Carlos Eduardo', 'Initials': 'CE', 'LastName': 'Pinfildi', 'Affiliation': 'Physical Therapy and Post-Graduation Interdisciplinary Health Science, Department of Human Movement Science (DHMS), Physical Therapy, University Federal of São Paulo, 11015020, Campus Baixada Santista, Santos, SP, Brazil.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'de Castro Pochini', 'Affiliation': 'Departamento de Ortopedia e Traumatologia, Programa de Pós-Graduação em Ciências da Saúde Aplicada ao Esporte e à Atividade Física, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Moisés', 'Initials': 'M', 'LastName': 'Cohen', 'Affiliation': 'Departamento de Ortopedia e Traumatologia, Programa de Pós-Graduação em Ciências da Saúde Aplicada ao Esporte e à Atividade Física, Universidade Federal de São Paulo, São Paulo, Brazil.'}]",Lasers in medical science,['10.1007/s10103-019-02858-6']
910,27872389,Promoting fruit and vegetable intake in childbearing age women at risk for gestational diabetes mellitus: A randomised controlled trial.,"This randomised controlled trial verified the efficacy of an implementation intentions intervention ( n = 24) to promote fruit and vegetable consumption among childbearing age women at risk for gestational diabetes mellitus against a control condition based on the question-behaviour effect ( n = 26). There was only a significant time effect ( F(2,85) = 5.69, p = 0.0048). Both groups increased their vegetable consumption compared to baseline at 3 months ( p = 0.0022) and 6 months ( p = 0.0042). There were no significant effects on weight, waist circumference and blood glucose levels. Implementation intentions and the question-behaviour effect appear to be effective behaviour change techniques to promote vegetable intake among this high-risk population.",2019,Both groups increased their vegetable consumption compared to baseline at 3 months ( p = 0.0022) and 6 months ( p = 0.0042).,"['childbearing age women at risk for gestational diabetes mellitus against a control condition based on the question-behaviour effect ( n\u2009=\u200926', 'childbearing age women at risk for gestational diabetes mellitus']","['implementation intentions intervention ( n\u2009=\u200924) to promote fruit and vegetable consumption', 'Promoting fruit and vegetable intake']","['vegetable consumption', 'weight, waist circumference and blood glucose levels']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}]","[{'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}]",,0.0721361,Both groups increased their vegetable consumption compared to baseline at 3 months ( p = 0.0022) and 6 months ( p = 0.0042).,"[{'ForeName': 'Lydi-Anne', 'Initials': 'LA', 'LastName': 'Vézina-Im', 'Affiliation': '1 Laval University, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Perron', 'Affiliation': '1 Laval University, Canada.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Lemieux', 'Affiliation': '1 Laval University, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Robitaille', 'Affiliation': '1 Laval University, Canada.'}]",Journal of health psychology,['10.1177/1359105316680021']
911,32157684,Empowering Older Adults to Discuss Advance Care Planning During Clinical Visits: The PREPARE Randomized Trial.,"BACKGROUND/OBJECTIVES


A patient-directed, online program (PREPARE for Your Care [PREPARE]; prepareforyourcare.org) has been shown to increase advance care planning (ACP) documentation. However, the mechanisms underlying PREPARE are unknown. Our objectives were to compare the efficacy of PREPARE plus an easy-to-read advance directive (AD) vs an AD alone to increase active patient participation in ACP discussions during clinic visits and to examine effects of active patient participation on ACP documentation.
DESIGN


Audio recordings of postintervention primary care visits from two randomized trials (2013-2016).
SETTING


Seven primary care clinics at a veterans affair and safety-net hospital in San Francisco, CA.
PARTICIPANTS


English- and Spanish-speaking adults, aged 55 years and older, with two or more chronic/serious conditions.
INTERVENTION


PREPARE plus an easy-to-read AD or an AD alone.
MEASUREMENTS


The primary outcome was the number of active patient participation utterances about ACP (eg, asking questions, stating preferences) measured by the validated Active Patient Participation Coding Scheme. We examined differences in utterances by study arm using mixed effects negative binomial models and utterances as a mediator of PREPARE's effect on documentation using adjusted logistic regression. Models were adjusted for health literacy, prior care planning, and clinician.
RESULTS


Among 393 participants, the mean (SD) age was 66 (8.1) years, 120 (30.5%) had limited health literacy, and 99 (25.2%) were Spanish speaking. PREPARE plus the AD resulted in 41% more active patient participation in ACP discussions compared with the AD alone (mean [SD] = 10.1 [16.8] vs 6.6 [13.4] utterances; incidence rate ratio = 1.41; 95% confidence interval = 1.00-1.98). For every additional utterance, participants had 15% higher odds of ACP documentation, and active patient participation accounted for 16% of PREPARE's effect on documentation.
CONCLUSIONS


The PREPARE program and easy-to-read AD empowered patients to actively participate in ACP discussions during clinical visits more than the AD alone. Increased activation was associated with increased ACP documentation. Therefore, PREPARE may mitigate barriers to ACP among English- and Spanish-speaking older adults.
TRIAL REGISTRATION


ClinicalTrials.gov identifiers: ""Improving Advance Care Planning by Preparing Diverse Seniors for Decision Making (PREPARE)"" NCT01990235 and ""Preparing Spanish-Speaking Older Adults for Advance Care Planning and Medical Decision Making (PREPARE)"" NCT02072941. J Am Geriatr Soc 68:1210-1217, 2020.",2020,PREPARE plus the AD resulted in 41% more active patient participation in ACP discussions compared with the AD alone (mean [SD] = 10.1 [16.8] vs 6.6 [13.4] utterances; incidence rate ratio = 1.41; 95% confidence interval = 1.00-1.98).,"['393 participants, the mean (SD) age was 66 (8.1) years, 120 (30.5%) had limited health literacy, and 99 (25.2%) were Spanish speaking', 'Seven primary care clinics at a veterans affair and safety-net hospital in San Francisco, CA', 'Empowering Older Adults', 'English- and Spanish-speaking adults, aged 55\u2009years and older, with two or more chronic/serious conditions']","['PREPARE plus an easy-to-read AD or an AD alone', 'Advance Care Planning']","['active patient participation in ACP discussions', 'number of active patient participation utterances about ACP (eg, asking questions, stating preferences', 'Increased activation']","[{'cui': 'C4517754', 'cui_str': 'Three hundred and ninety-three'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517875', 'cui_str': '8.1 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C3661443', 'cui_str': 'Safety-net Hospitals'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332219', 'cui_str': 'Easy (qualifier value)'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0600371', 'cui_str': 'Advance Health Care Planning'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0030699', 'cui_str': 'Patient Involvement'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0566217', 'cui_str': 'Does ask questions (finding)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",,0.0986627,PREPARE plus the AD resulted in 41% more active patient participation in ACP discussions compared with the AD alone (mean [SD] = 10.1 [16.8] vs 6.6 [13.4] utterances; incidence rate ratio = 1.41; 95% confidence interval = 1.00-1.98).,"[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Freytag', 'Affiliation': 'Center for Innovations in Quality Effectiveness, and Safety, Houston, Texas.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Street', 'Affiliation': 'Center for Innovations in Quality Effectiveness, and Safety, Houston, Texas.'}, {'ForeName': 'Deborah E', 'Initials': 'DE', 'LastName': 'Barnes', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'San Francisco Veterans Affairs Health Care System, San Francisco, California.'}, {'ForeName': 'Aiesha M', 'Initials': 'AM', 'LastName': 'Volow', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Janet K', 'Initials': 'JK', 'LastName': 'Shim', 'Affiliation': 'Department of Social and Behavioral Sciences, School of Nursing, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Stewart C', 'Initials': 'SC', 'LastName': 'Alexander', 'Affiliation': 'Department of Consumer Science, Purdue University, West Lafayette, Indiana.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Sudore', 'Affiliation': 'Innovation and Implementation Center for Aging and Palliative Care, Division of Geriatrics, Department of Medicine, University of California, San Francisco, San Francisco, California.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16405']
912,32078356,Breakfast in the Classroom Initiative and Students' Breakfast Consumption Behaviors: A Group Randomized Trial.,"Objectives.  To identify the effect of a Breakfast in the Classroom (BIC) initiative on the foods and drinks students consume in the morning. Methods.  Sixteen public schools in Philadelphia, Pennsylvania, that provide universal breakfast participated in a group randomized trial to examine the effects of BIC with complementary nutrition promotion between 2013 and 2016. Control schools (n = 8) offered breakfast in the cafeteria before school. Baseline data were collected from 1362 students in grades 4 to 6. Endpoint data were collected after 2.5 years. Students self-reported the foods and drinks they consumed in the morning. Results.  At endpoint, there was no effect of the intervention on breakfast skipping. Nearly 30% of intervention students consumed breakfast foods or drinks from multiple locations, as compared with 21% of control students. A greater proportion of intervention students than control students consumed 100% juice, and a smaller proportion consumed sugar-sweetened beverages and foods high in saturated fat and added sugar. Conclusions.  A BIC initiative led to improvements in the types of foods and drinks students consumed in the morning. However, the program did not reduce breakfast skipping and increased the number of locations where students ate.",2020,"A greater proportion of intervention students than control students consumed 100% juice, and a smaller proportion consumed sugar-sweetened beverages and foods high in saturated fat and added sugar.","['1362 students in grades 4 to 6', ""Breakfast in the Classroom Initiative and Students' Breakfast Consumption Behaviors"", 'Sixteen public schools in Philadelphia, Pennsylvania, that provide universal breakfast participated']",[],['breakfast skipping'],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0557800', 'cui_str': 'Public school (environment)'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}]",[],"[{'cui': 'C4553621', 'cui_str': 'With breakfast'}]",,0.0326703,"A greater proportion of intervention students than control students consumed 100% juice, and a smaller proportion consumed sugar-sweetened beverages and foods high in saturated fat and added sugar.","[{'ForeName': 'Katherine W', 'Initials': 'KW', 'LastName': 'Bauer', 'Affiliation': 'Katherine W. Bauer and Heidi M. Weeks are with the Department of Nutritional Sciences, University of Michigan School of Public Health, Ann Arbor. Gary D. Foster is with WW International (formerly known as Weight Watchers), New York, NY. Heather M. Polonsky and Jennifer O. Fisher are with the Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA. Adam Davey is with the College of Health Sciences and the Department of Behavioral Health and Nutrition, University of Delaware, Newark. Sandy Sherman, Michelle L. Abel, and Lauren C. Dale are with The Food Trust, Philadelphia. Karen J. Ruth is with the Fox Chase Cancer Center, Temple Health, Philadelphia.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Foster', 'Affiliation': 'Katherine W. Bauer and Heidi M. Weeks are with the Department of Nutritional Sciences, University of Michigan School of Public Health, Ann Arbor. Gary D. Foster is with WW International (formerly known as Weight Watchers), New York, NY. Heather M. Polonsky and Jennifer O. Fisher are with the Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA. Adam Davey is with the College of Health Sciences and the Department of Behavioral Health and Nutrition, University of Delaware, Newark. Sandy Sherman, Michelle L. Abel, and Lauren C. Dale are with The Food Trust, Philadelphia. Karen J. Ruth is with the Fox Chase Cancer Center, Temple Health, Philadelphia.'}, {'ForeName': 'Heidi M', 'Initials': 'HM', 'LastName': 'Weeks', 'Affiliation': 'Katherine W. Bauer and Heidi M. Weeks are with the Department of Nutritional Sciences, University of Michigan School of Public Health, Ann Arbor. Gary D. Foster is with WW International (formerly known as Weight Watchers), New York, NY. Heather M. Polonsky and Jennifer O. Fisher are with the Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA. Adam Davey is with the College of Health Sciences and the Department of Behavioral Health and Nutrition, University of Delaware, Newark. Sandy Sherman, Michelle L. Abel, and Lauren C. Dale are with The Food Trust, Philadelphia. Karen J. Ruth is with the Fox Chase Cancer Center, Temple Health, Philadelphia.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Polonsky', 'Affiliation': 'Katherine W. Bauer and Heidi M. Weeks are with the Department of Nutritional Sciences, University of Michigan School of Public Health, Ann Arbor. Gary D. Foster is with WW International (formerly known as Weight Watchers), New York, NY. Heather M. Polonsky and Jennifer O. Fisher are with the Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA. Adam Davey is with the College of Health Sciences and the Department of Behavioral Health and Nutrition, University of Delaware, Newark. Sandy Sherman, Michelle L. Abel, and Lauren C. Dale are with The Food Trust, Philadelphia. Karen J. Ruth is with the Fox Chase Cancer Center, Temple Health, Philadelphia.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Davey', 'Affiliation': 'Katherine W. Bauer and Heidi M. Weeks are with the Department of Nutritional Sciences, University of Michigan School of Public Health, Ann Arbor. Gary D. Foster is with WW International (formerly known as Weight Watchers), New York, NY. Heather M. Polonsky and Jennifer O. Fisher are with the Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA. Adam Davey is with the College of Health Sciences and the Department of Behavioral Health and Nutrition, University of Delaware, Newark. Sandy Sherman, Michelle L. Abel, and Lauren C. Dale are with The Food Trust, Philadelphia. Karen J. Ruth is with the Fox Chase Cancer Center, Temple Health, Philadelphia.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Sherman', 'Affiliation': 'Katherine W. Bauer and Heidi M. Weeks are with the Department of Nutritional Sciences, University of Michigan School of Public Health, Ann Arbor. Gary D. Foster is with WW International (formerly known as Weight Watchers), New York, NY. Heather M. Polonsky and Jennifer O. Fisher are with the Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA. Adam Davey is with the College of Health Sciences and the Department of Behavioral Health and Nutrition, University of Delaware, Newark. Sandy Sherman, Michelle L. Abel, and Lauren C. Dale are with The Food Trust, Philadelphia. Karen J. Ruth is with the Fox Chase Cancer Center, Temple Health, Philadelphia.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Abel', 'Affiliation': 'Katherine W. Bauer and Heidi M. Weeks are with the Department of Nutritional Sciences, University of Michigan School of Public Health, Ann Arbor. Gary D. Foster is with WW International (formerly known as Weight Watchers), New York, NY. Heather M. Polonsky and Jennifer O. Fisher are with the Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA. Adam Davey is with the College of Health Sciences and the Department of Behavioral Health and Nutrition, University of Delaware, Newark. Sandy Sherman, Michelle L. Abel, and Lauren C. Dale are with The Food Trust, Philadelphia. Karen J. Ruth is with the Fox Chase Cancer Center, Temple Health, Philadelphia.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Ruth', 'Affiliation': 'Katherine W. Bauer and Heidi M. Weeks are with the Department of Nutritional Sciences, University of Michigan School of Public Health, Ann Arbor. Gary D. Foster is with WW International (formerly known as Weight Watchers), New York, NY. Heather M. Polonsky and Jennifer O. Fisher are with the Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA. Adam Davey is with the College of Health Sciences and the Department of Behavioral Health and Nutrition, University of Delaware, Newark. Sandy Sherman, Michelle L. Abel, and Lauren C. Dale are with The Food Trust, Philadelphia. Karen J. Ruth is with the Fox Chase Cancer Center, Temple Health, Philadelphia.'}, {'ForeName': 'Lauren C', 'Initials': 'LC', 'LastName': 'Dale', 'Affiliation': 'Katherine W. Bauer and Heidi M. Weeks are with the Department of Nutritional Sciences, University of Michigan School of Public Health, Ann Arbor. Gary D. Foster is with WW International (formerly known as Weight Watchers), New York, NY. Heather M. Polonsky and Jennifer O. Fisher are with the Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA. Adam Davey is with the College of Health Sciences and the Department of Behavioral Health and Nutrition, University of Delaware, Newark. Sandy Sherman, Michelle L. Abel, and Lauren C. Dale are with The Food Trust, Philadelphia. Karen J. Ruth is with the Fox Chase Cancer Center, Temple Health, Philadelphia.'}, {'ForeName': 'Jennifer O', 'Initials': 'JO', 'LastName': 'Fisher', 'Affiliation': 'Katherine W. Bauer and Heidi M. Weeks are with the Department of Nutritional Sciences, University of Michigan School of Public Health, Ann Arbor. Gary D. Foster is with WW International (formerly known as Weight Watchers), New York, NY. Heather M. Polonsky and Jennifer O. Fisher are with the Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA. Adam Davey is with the College of Health Sciences and the Department of Behavioral Health and Nutrition, University of Delaware, Newark. Sandy Sherman, Michelle L. Abel, and Lauren C. Dale are with The Food Trust, Philadelphia. Karen J. Ruth is with the Fox Chase Cancer Center, Temple Health, Philadelphia.'}]",American journal of public health,['10.2105/AJPH.2019.305511']
913,31734069,Thermal ablation versus cryotherapy or loop excision to treat women positive for cervical precancer on visual inspection with acetic acid test: pilot phase of a randomised controlled trial.,"BACKGROUND


Cryotherapy is standard practice for treating patients with cervical precancer in see-and-treat programmes in low-income and middle-income countries (LMICs). Because of logistical difficulties with cryotherapy (eg, the necessity, costs, and supply chain difficulties of refrigerant gas; equipment failure; and treatment duration >10 min), a battery-operated thermal ablator that is lightweight and portable has been developed. We aimed to compare thermal ablation using the new device with cryotherapy.
METHODS


We report the pilot phase of a randomised controlled trial in routine screen-and-treat clinics providing cervical screening using visual inspection with acetic acid (VIA) in Lusaka, Zambia. We recruited non-pregnant women, aged 25 years or older, who were eligible for ablative therapy. We randomly assigned participants (1:1:1) to thermal ablation, cryotherapy, or large loop excision of the transformation zone (LLETZ), using computer-generated allocation. The randomisation was concealed but the nurses providing treatment and the participants were unmasked. Thermal ablation was achieved using the Liger thermal ablator (using 1-5 overlapping applications of the probe heated to 100°C, each application lasting for 40 s), cryotherapy was carried out using the double-freeze technique (freeze for 3 min, thaw for 5 min, and freeze again for 3 min), and LLETZ (using a large loop driven by an electro-surgical unit to excise the transformation zone) was done under local anaesthesia. The primary endpoint was treatment success, defined as either human papillomavirus (HPV) type-specific clearance among participants who were positive for the same HPV type at baseline, or a negative VIA test at 6-month follow-up, if the baseline HPV test was negative. Per protocol analyses were done. Enrolment for the full trial is ongoing. Here, we present findings from a prespecified pilot phase of the full trial. The final analysis of the full trial will assess non-inferiority of the groups for the primary efficacy endpoint. The study is registered with ClinicalTrials.gov, number NCT02956239.
FINDINGS


Between Aug 2, 2017, and Jan 15, 2019, 750 participants were randomly assigned (250 per group). 206 (84%) participants in the cryotherapy group, 197 (81%) in the thermal ablation group, and 204 (84%) in the LLETZ group attended the 6-month follow-up examination. Treatment success was reported in 120 (60%) of 200 participants in the cryotherapy group, 123 (64%) of 192 in the thermal ablation group, and 134 (67%) of 199 in the LLETZ group (p=0·31). Few participants complained of moderate to severe pain in any group immediately after the procedure (six [2%] of 250 in the cryotherapy group, four [2%] of 250 in the thermal ablation group, and five [2%] of 250 in the LLETZ group) and 2 weeks after the procedure (one [<1%] of 241 in the cryotherapy group, none of 242 in the thermal ablation group, and two [<1%] of 237 in the LLETZ group). None of the participants reported any complication requiring medical consultation or admission to hospital.
INTERPRETATION


Results from this pilot study preliminarily suggest that thermal ablation has similar treatment success to cryotherapy, without the practical disadvantages of providing cryotherapy in an LMIC. However, the study was not powered to establish the similarity between the techniques, and results from the ongoing randomised controlled trial are need to confirm these results.
FUNDING


US National Institutes of Health.",2020,"Treatment success was reported in 120 (60%) of 200 participants in the cryotherapy group, 123 (64%) of 192 in the thermal ablation group, and 134 (67%) of 199 in the LLETZ group (p=0·31).","['Between Aug 2, 2017, and Jan 15, 2019', '750 participants', 'recruited non-pregnant women, aged 25 years or older, who were eligible for ablative therapy', 'patients with cervical precancer in see-and-treat programmes in low-income and middle-income countries (LMICs']","['Thermal ablation versus cryotherapy or loop excision', 'thermal ablation, cryotherapy, or large loop excision of the transformation zone (LLETZ), using computer-generated allocation', 'routine screen-and-treat clinics providing cervical screening using visual inspection with acetic acid (VIA', 'LLETZ']","['treatment success, defined as either human papillomavirus (HPV) type-specific clearance', 'severe pain', 'complication requiring medical consultation or admission to hospital', 'Treatment success']","[{'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0677798', 'cui_str': 'Thermal ablation'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0445022', 'cui_str': 'Loop (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C3714584', 'cui_str': 'Transformation, function (observable entity)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0199219', 'cui_str': 'Visual observation'}, {'cui': 'C0766298', 'cui_str': '(methylsulfanyl)acetic acid'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}]",750.0,0.164652,"Treatment success was reported in 120 (60%) of 200 participants in the cryotherapy group, 123 (64%) of 192 in the thermal ablation group, and 134 (67%) of 199 in the LLETZ group (p=0·31).","[{'ForeName': 'Leeya F', 'Initials': 'LF', 'LastName': 'Pinder', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Washington, Seattle, WA, USA; Obstetrics and Gynecology, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Groesbeck P', 'Initials': 'GP', 'LastName': 'Parham', 'Affiliation': 'Obstetrics and Gynecology, University of Zambia, Lusaka, Zambia; Department of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Partha', 'Initials': 'P', 'LastName': 'Basu', 'Affiliation': 'Screening Group, Early Detection and Prevention Section, International Agency for Research on Cancer, WHO, Lyon, France. Electronic address: basup@iarc.fr.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Muwonge', 'Affiliation': 'Screening Group, Early Detection and Prevention Section, International Agency for Research on Cancer, WHO, Lyon, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lucas', 'Affiliation': 'Screening Group, Early Detection and Prevention Section, International Agency for Research on Cancer, WHO, Lyon, France.'}, {'ForeName': 'Namakau', 'Initials': 'N', 'LastName': 'Nyambe', 'Affiliation': 'UNC Global Project-Zambia, Lusaka, Zambia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sauvaget', 'Affiliation': 'Screening Group, Early Detection and Prevention Section, International Agency for Research on Cancer, WHO, Lyon, France.'}, {'ForeName': 'Mulindi H', 'Initials': 'MH', 'LastName': 'Mwanahamuntu', 'Affiliation': 'Department of Obstetrics and Gynecology, Women and Newborn Hospital, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Rengaswamy', 'Initials': 'R', 'LastName': 'Sankaranarayanan', 'Affiliation': 'Research Triangle Institute, International-India, Commercial Tower, Pullman Hotel Aerocity, New Delhi, India.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Prendiville', 'Affiliation': 'Screening Group, Early Detection and Prevention Section, International Agency for Research on Cancer, WHO, Lyon, France.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30635-7']
914,31430268,Randomized Controlled Phase 2a Study of RPh201 in Previous Nonarteritic Anterior Ischemic Optic Neuropathy.,"BACKGROUND


No proven treatment exists for nonarteritic anterior ischemic optic neuropathy (NAION), either in the acute or late phase.
OBJECTIVE


To assess safety and changes in visual function and structure after RPh201/placebo treatment in participants with previous NAION.
DESIGN AND SETTING


Phase 2a, single-site, prospective, randomized, placebo-controlled, double-masked trial (registration NCT02045212).
MAIN OUTCOMES MEASURES


Early Treatment Diabetic Retinopathy Study best-corrected visual acuity (BCVA), visual fields, retinal nerve fiber layer, and visual evoked potential at weeks 13, 26, and after a 13-week wash-out (""off-drug"") period; and safety.
STUDY POPULATION


Twenty-two participants aged 18 years or older with previous NAION.
INTERVENTION(S)


RPh201 (20 mg) or placebo (cottonseed oil vehicle) administered subcutaneously twice weekly at the study site.
RESULTS


Thirteen men and 9 women were randomized, of which 20 completed all visits. The mean (±SD) age was 61.0 ± 7.6 years. In a post hoc analysis, after 26 weeks of treatment, BCVA improved by ≥15 letters in 4/11 (36.4%) eyes with RPh201, compared to 1/8 (12.5%) eyes with placebo (P = 0.24). Overall, 7/11 (63.6%) of participants on RPh201 showed some improvement in BCVA, compared with 3/8 (37.5%) on placebo (P = 0.26). Improvement in BCVA from a calculated baseline was 14.8 ± 15.8 letters for RPh201 and 6.6 ± 15.3 for placebo (P = 0.27). Of the 154 adverse effects (AEs), 52 were considered related to the study procedures/treatment. Across the study and 1,017 injections, the most frequently reported AE was injection site pain (23 events in 5 participants). There were no clinically significant changes in vital signs or laboratory values.
CONCLUSIONS


This Phase 2a was designed to assess safety, feasibility, and explore potential efficacy signals in treating previous NAION with RPh201. No safety concerns were raised. The results support a larger trial in patients with previous NAION.",2019,"Overall, 7/11 (63.6%) of participants on RPh201 showed some improvement in BCVA, compared with 3/8 (37.5%) on placebo (P = 0.26).","['participants with previous NAION', 'Twenty-two participants aged 18 years or older with previous NAION', 'Previous Nonarteritic Anterior Ischemic Optic Neuropathy', 'patients with previous NAION', 'Thirteen men and 9 women']","['placebo', 'RPh201 (20 mg) or placebo (cottonseed oil vehicle', 'RPh201']","['BCVA', 'vital signs or laboratory values', 'Diabetic Retinopathy Study best-corrected visual acuity (BCVA), visual fields, retinal nerve fiber layer, and visual evoked potential']","[{'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1852242', 'cui_str': 'NAION'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0010198', 'cui_str': 'Cottonseed Oil'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}]","[{'cui': 'C0518766'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0042826', 'cui_str': 'Visual Fields'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C1720466', 'cui_str': 'Nerve fiber layer'}, {'cui': 'C0546834', 'cui_str': 'Visual evoked potential study'}]",22.0,0.607336,"Overall, 7/11 (63.6%) of participants on RPh201 showed some improvement in BCVA, compared with 3/8 (37.5%) on placebo (P = 0.26).","[{'ForeName': 'Eitan Z', 'Initials': 'EZ', 'LastName': 'Rath', 'Affiliation': 'Ophthalmology Department (EZR, ZIS), Galilee Medical Center, Nahariya; and Azrieli Faculty of Medicine, Bar-Ilan University, Safed, Israel; Regenera Pharma Ltd (ZH, KA), Israel; Goldschleger Eye Research Institute (AS), Sheba Medical Center, Tel Aviv University, Tel Hashomer, Israel; and Departments of Ophthalmology and Visual Sciences, Neurology and Neurosurgery (LAL), McGill University, Montreal, Canada.'}, {'ForeName': 'Zadik', 'Initials': 'Z', 'LastName': 'Hazan', 'Affiliation': ''}, {'ForeName': 'Konstantin', 'Initials': 'K', 'LastName': 'Adamsky', 'Affiliation': ''}, {'ForeName': 'Arieh', 'Initials': 'A', 'LastName': 'Solomon', 'Affiliation': ''}, {'ForeName': 'Zvi I', 'Initials': 'ZI', 'LastName': 'Segal', 'Affiliation': ''}, {'ForeName': 'Leonard A', 'Initials': 'LA', 'LastName': 'Levin', 'Affiliation': ''}]",Journal of neuro-ophthalmology : the official journal of the North American Neuro-Ophthalmology Society,['10.1097/WNO.0000000000000786']
915,30689042,"Long-term, open-label, phase 3 study of rasagiline in Japanese patients with early Parkinson's disease.","Rasagiline is a monoamine oxidase B inhibitor with demonstrated efficacy and safety in patients with Parkinson's disease (PD). We recently conducted the first randomized, double-blind, placebo-controlled trial of rasagiline in Japanese patients with early PD and now report the results of its open-label extension (clinicaltrials.gov, NCT02337751). In the double-blind trial, patients aged 30-79 years with PD diagnosis within 5 years and Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III total score ≥ 14 were randomized to placebo or rasagiline 1 mg/day for 26 weeks. Of 210 patients who completed the randomized trial, 198 (95 placebo, 103 rasagiline) entered the extension and received rasagiline 1 mg/day for 26 weeks. Analyses included patients who received rasagiline anytime during double-blind and/or extension periods; mean (standard deviation) treatment duration was 169.6 (39.57) and 316.5 (88.89) days in placebo-rasagiline (n = 95) and rasagiline-rasagiline (n = 117) groups, respectively. The incidence of treatment-emergent adverse events (TEAEs; primary outcome) was 53.7% and 77.8% in the placebo-rasagiline and rasagiline-rasagiline groups, respectively. Drug-related TEAEs occurred in 24.2% and 49.6% of patients and serious TEAEs occurred in four (two drug related) and six (one drug related) patients in the placebo-rasagiline and rasagiline-rasagiline groups, respectively. The mean change in MDS-UPDRS Part II + III total score from baseline (before rasagiline) was - 2.8 points in both the placebo-rasagiline (mean [95% confidence interval] - 2.8 [- 4.05, - 1.59]) and rasagiline-rasagiline (- 2.8 [- 4.57, - 1.01]) groups. In conclusion, up to 52 weeks, rasagiline was well tolerated with sustained motor symptom improvement, supporting its use in Japanese patients with early PD.",2019,"Drug-related TEAEs occurred in 24.2% and 49.6% of patients and serious TEAEs occurred in four (two drug related) and six (one drug related) patients in the placebo-rasagiline and rasagiline-rasagiline groups, respectively.","['Part\xa0II\u2009+\u2009Part\xa0III total score\u2009≥\u200914', 'Japanese patients with early PD', ""patients aged 30-79\xa0years with PD diagnosis within 5\xa0years and Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS"", 'patients who received rasagiline anytime during double-blind and/or extension periods; mean (standard deviation) treatment duration was 169.6 (39.57) and 316.5 (88.89) days in', '210 patients who completed the randomized trial, 198 (95 placebo, 103 rasagiline) entered the', ""patients with Parkinson's disease (PD"", ""Japanese patients with early Parkinson's disease""]","['extension and received rasagiline', 'placebo', 'rasagiline-rasagiline', 'placebo or rasagiline', 'placebo-rasagiline', 'rasagiline']","['mean change in MDS-UPDRS Part\xa0II\u2009+\u2009III total score', 'rasagiline-rasagiline', 'efficacy and safety']","[{'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0026650', 'cui_str': 'Movement Disorder Syndromes'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}, {'cui': 'C0525678', 'cui_str': 'rasagiline'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0525678', 'cui_str': 'rasagiline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0525678', 'cui_str': 'rasagiline'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",210.0,0.339167,"Drug-related TEAEs occurred in 24.2% and 49.6% of patients and serious TEAEs occurred in four (two drug related) and six (one drug related) patients in the placebo-rasagiline and rasagiline-rasagiline groups, respectively.","[{'ForeName': 'Nobutaka', 'Initials': 'N', 'LastName': 'Hattori', 'Affiliation': 'Department of Neurology, Juntendo University Faculty of Medicine, 2-1-1, Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan. nhattori@jutendo.ac.jp.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Takeda', 'Affiliation': 'Department of Neurology, National Hospital Organization Sendai Nishitaga Hospital, Miyagi, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Takeda', 'Affiliation': 'Japan Development Center, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Nishimura', 'Affiliation': 'Japan Development Center, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Tadayuki', 'Initials': 'T', 'LastName': 'Kitagawa', 'Affiliation': 'Japan Development Center, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Mochizuki', 'Affiliation': 'Department of Neurology, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nagai', 'Affiliation': 'Clinical Therapeutic Trial Center, Ehime University Hospital, Ehime, Japan.'}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Takahashi', 'Affiliation': 'Department of Neurology, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}]","Journal of neural transmission (Vienna, Austria : 1996)",['10.1007/s00702-018-1964-3']
916,32152817,Effect of lymphedema self-management group-based education compared with social network-based education on quality of life and fear of cancer recurrence in women with breast cancer: a randomized controlled clinical trial.,"BACKGROUND


Breast cancer-related lymphedema (BCRL) and its associated symptoms harm the quality of life (QoL) of cancer survivors and can stimulate fear of cancer recurrence (FCR). Self-management education for lymphedema has been introduced as an effective method in controlling FCR. This study investigates the effect of lymphedema group-based education compared to the social network-based and control group on QoL and FCR in breast cancer patients.
METHODS


This three-arm clinical trial studied 105 patients with breast cancer-related lymphedema referred to Seyed_Khandan rehabilitation center. Sampling was done by random allocation method in blocks of 3 with 35 subjects in each group. All subjects received routine lymphedema treatments. The group-based education (GE) and social network-based education (SNE) groups received self-management education in the clinic and Telegram™ messenger channel, respectively. Impairment in QoL and mean score of FCR were assessed before, immediately after, and three months after the intervention by using the Persian version of Lymphedema Life Impact Scale (LLIS) and Fear of Progression Questionnaire-Short Form (FoPQ-SF), respectively. Mixed-model ANOVA was applied for statistical analysis.
RESULTS


There was a significant time effect on total LLIS (P = 0.007), psychosocial (P = 0.038) and functional (P = 0.024) subscale changes in three groups of study. Interaction between the main effect of group and time on psychosocial subscale changes was statistically significant (P = 0.017). The multicomparison results illustrated that the main effect of time, the main effect of group, and interaction of them on the mean score of FCR were P = 0.084, P = 0.380, and P = 0.568, respectively.
CONCLUSION


Despite no significant reduction in the FCR score, results showed the improvement of most QoL aspects after three months of intervention. Although the social network-based education method was effective, the group-based education method was more beneficial. Applying these educational methods in lymphedema treatment protocols needs cost-effectiveness studies.
TRIAL REGISTRATION


This study was registered at the Iranian Registry of Clinical Trials (IRCT2017052834176N1).",2020,Interaction between the main effect of group and time on psychosocial subscale changes was statistically significant (P = 0.017).,"['105 patients with breast cancer-related lymphedema referred to Seyed_Khandan rehabilitation center', 'women with breast cancer', 'breast cancer patients']","['lymphedema group-based education', 'lymphedema self-management group-based education compared with social network-based education', 'education (GE) and social network-based education (SNE) groups received self-management education', 'social network-based and control group', 'routine lymphedema treatments']","['quality of life (QoL) of cancer survivors', 'fear of cancer recurrence (FCR', 'FCR score', 'Persian version of Lymphedema Life Impact Scale (LLIS) and Fear of Progression Questionnaire-Short Form (FoPQ-SF', 'total LLIS', 'Impairment in QoL and mean score of FCR', 'quality of life and fear of cancer recurrence', 'psychosocial subscale changes', 'mean score of FCR']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}, {'cui': 'C0034993', 'cui_str': 'Rehabilitation Centers'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0034380'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0233705', 'cui_str': 'Fear of getting cancer (finding)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",105.0,0.0463289,Interaction between the main effect of group and time on psychosocial subscale changes was statistically significant (P = 0.017).,"[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Omidi', 'Affiliation': 'Department of Reproductive Health and Midwifery, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Masoomeh', 'Initials': 'M', 'LastName': 'Kheirkhah', 'Affiliation': 'Nursing Care Research Center (NCRC), School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Jamileh', 'Initials': 'J', 'LastName': 'Abolghasemi', 'Affiliation': 'Department of Biostatistics, School of Public Health, Iran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Shahpar', 'Initials': 'S', 'LastName': 'Haghighat', 'Affiliation': 'Breast Cancer Research Center, Motamed Cancer Institute, ACECR, Tehran, Iran. sha_haghighat@yahoo.com.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-020-02455-z']
917,31124023,Effectiveness of Facebook Groups to Boost Participation in a Parenting Intervention.,"Although family-based prevention programs have been shown to be effective at reducing adolescent substance use, it is often difficult and costly to recruit and retain parents in programs administered in person. The current study tested whether program engagement and parenting practices could be improved by offering parents in a self-directed family program access to a private Facebook group. Parents of middle school children (N = 103) were recruited through paid Facebook ads to a 5-week self-directed teen substance use prevention program to be completed at home together by parents and their children. Two thirds of parents (N = 72) were randomly assigned to a moderated private Facebook group that provided a forum for parents in the study to interact with each other, and one third (N = 31) were randomized to use the intervention materials without additional support. Relatively few parents participated in the Facebook group and most did not find the experience useful. However, satisfaction with the program assessed 3 months after program completion was high among all parents and most parents engaged with the materials, irrespective of Facebook group assignment. Overall, parents reported significantly lower conflict and more household rules 6 months post-intervention compared to baseline. Parenting practices did not change more among those assigned to the Facebook group than among parents who used the materials on their own. The current findings suggest that providing opportunities for parents to interact online while participating in a self-directed family intervention may not help to increase engagement or improvements in parenting practices, particularly when few parents engage with each other.",2019,Parenting practices did not change more among those assigned to the Facebook group than among parents who used the materials on their own.,"['Two\xa0thirds of parents (N\u2009=\u200972', 'Parents of middle school children (N\u2009=\u2009103) were recruited through paid Facebook ads to a 5-week self-directed teen substance use prevention program to be completed at home together by parents and their children']","['intervention materials without additional support', 'moderated private Facebook', 'Facebook']",[],"[{'cui': 'C0205437', 'cui_str': 'Third (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0150358', 'cui_str': 'Substance use prevention (procedure)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}]",[],103.0,0.0303321,Parenting practices did not change more among those assigned to the Facebook group than among parents who used the materials on their own.,"[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Epstein', 'Affiliation': 'Social Development Research Group, School of Social Work, University of Washington, 9725 3rd Ave NE, Suite 401, Seattle, WA, 98115, USA. marinaep@uw.edu.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Oesterle', 'Affiliation': 'Social Development Research Group, School of Social Work, University of Washington, 9725 3rd Ave NE, Suite 401, Seattle, WA, 98115, USA.'}, {'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Haggerty', 'Affiliation': 'Social Development Research Group, School of Social Work, University of Washington, 9725 3rd Ave NE, Suite 401, Seattle, WA, 98115, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-019-01018-0']
918,31203241,Molidustat for the treatment of renal anaemia in patients with dialysis-dependent chronic kidney disease: design and rationale of three phase III studies.,"INTRODUCTION


New medications for anaemia associated with chronic kidney disease (CKD) are desirable, owing to the limitations of erythropoiesis-stimulating agents (ESAs), the current standard of care. Molidustat is a novel hypoxia-inducible factor prolyl-hydroxylase inhibitor that stimulates erythropoietin production, predominately in the kidney. We report methodological details of three phase III trials, named MolIdustat once dailY improves renal Anaemia By Inducing erythropoietin (MIYABI), designed primarily to investigate the efficacy of molidustat therapy in adults with renal anaemia and dialysis-dependent CKD.
METHODS AND ANALYSIS


MIYABI Haemodialysis-Correction (HD-C) is a single-arm trial (24-week treatment duration) in approximately 25 patients on haemodialysis, currently untreated with ESAs. MIYABI Peritoneal Dialysis (PD) is a single-arm trial (36 week treatment duration) in approximately 50 patients on peritoneal dialysis, treated or untreated with ESAs. MIYABI Haemodialysis-Maintenance (HD-M) is a randomised, active-controlled, double-blinded, double-dummy trial (52-week treatment duration) comparing molidustat with darbepoetin alfa in approximately 225 patients on haemodialysis, treated with ESAs. Molidustat (starting dose 75 mg/day) will be titrated 4-weekly to maintain haemoglobin in predetermined target ranges. The primary objective is to evaluate the efficacy of molidustat, using the following measures: the rate of rise in haemoglobin (g/L/week) at the first dose change up to week 8 (MIYABI HD-C); responder rate (MIYABI HD-C and MIYABI PD); mean haemoglobin level during weeks 33-36 and non-inferiority to darbepoetin alfa shown by change in mean haemoglobin level from baseline (MIYABI HD-M). The secondary objectives are to assess safety, pharmacokinetics and pharmacodynamics. These trials will provide the first evaluations of molidustat therapy in patients receiving either peritoneal dialysis or currently untreated with ESAs on haemodialysis, and provide further evidence in patients treated with ESAs on haemodialysis.
ETHICS AND DISSEMINATION


The protocols were approved by ethics committees at all participating sites. The trials will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice. Results arising from these studies will be published in peer-reviewed journal(s).
TRIAL REGISTRATION NUMBERS


NCT03351166; Pre-results, NCT03418168; Pre-results, NCT03543657; Pre-results.",2019,"Molidustat is a novel hypoxia-inducible factor prolyl-hydroxylase inhibitor that stimulates erythropoietin production, predominately in the kidney.","['approximately 225 patients on haemodialysis, treated with ESAs', 'patients treated with ESAs on haemodialysis', 'anaemia associated with chronic kidney disease (CKD', 'patients receiving either peritoneal dialysis or currently untreated with ESAs on haemodialysis', 'patients with dialysis-dependent chronic kidney disease', 'adults with renal anaemia and dialysis-dependent CKD', 'approximately 25 patients on haemodialysis, currently untreated with ESAs', 'approximately 50 patients on peritoneal dialysis, treated or untreated with ESAs']",['molidustat with darbepoetin alfa'],"['responder rate (MIYABI HD-C and MIYABI PD); mean haemoglobin level', 'renal Anaemia', 'renal anaemia', 'safety, pharmacokinetics and pharmacodynamics', 'rate of rise in haemoglobin']","[{'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal Dialysis'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1142276', 'cui_str': 'Renal anemia'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C4078705', 'cui_str': 'molidustat'}, {'cui': 'C0937950', 'cui_str': 'darbepoetin alfa'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1142276', 'cui_str': 'Renal anemia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0035853', 'cui_str': 'Rose'}]",,0.0767605,"Molidustat is a novel hypoxia-inducible factor prolyl-hydroxylase inhibitor that stimulates erythropoietin production, predominately in the kidney.","[{'ForeName': 'Tadao', 'Initials': 'T', 'LastName': 'Akizawa', 'Affiliation': 'Division of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Taguchi', 'Affiliation': 'MAF Pulmonology & Cardiology, Medical Affairs, Bayer Yakuhin, Ltd, Osaka, Japan.'}, {'ForeName': 'Yoshimi', 'Initials': 'Y', 'LastName': 'Matsuda', 'Affiliation': 'Statistics & Data Insights, Data Sciences & Analytics, Research & Development, Bayer Yakuhin, Ltd, Osaka, Japan.'}, {'ForeName': 'Kazuma', 'Initials': 'K', 'LastName': 'Iekushi', 'Affiliation': 'MAF Pulmonology & Cardiology, Medical Affairs, Bayer Yakuhin, Ltd, Osaka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'TA Thrombosis & Nephrology, Clinical Development & Operations, Research & Development, Bayer Yakuhin, Ltd, Osaka, Japan.'}, {'ForeName': 'Hiroyasu', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.'}]",BMJ open,['10.1136/bmjopen-2018-026602']
919,30281086,Single-Session Mobile-Augmented Intervention in Serious Mental Illness: A Three-Arm Randomized Controlled Trial.,"Psychosocial interventions for serious mental illness are resource intensive and poorly accessible. Brief interventions (eg, single session) that are augmented by follow-on automated mobile health intervention may expand treatment access. This was a randomized single-blind controlled trial with 255 individuals diagnosed with schizophrenia or bipolar disorder. Participants were randomized to one of three conditions: CBT2go, which combined one individual session of cognitive behavioral therapy with automated thought challenging/adaptive behavior delivered through mobile devices; Self-Monitoring (SM), which combined single-session illness psychoeducation with self-monitoring of symptoms; and treatment-as-usual (TAU). Participants were assessed at baseline, 6 weeks (midpoint), 12 weeks (posttreatment), and 24 weeks (follow-up) with our primary outcome global psychopathology (Brief Psychiatric Rating Scale-expanded version [BPRS-24]), and secondary outcomes community functioning (Specific Level of Function; SLOF) and defeatist performance beliefs (DPBs). We also collected data on adverse events. Outcome analyses on the primary outcome, BPRS Total score, indicated a significant time (0-24 wk) by group interaction with significant but modest improvement comparing two active conditions (CBT2go and SM) relative to TAU. Effects of CBT2go were not different from SM. There was a significant time × group interaction with better SLOF scores in CBT2go across 24 weeks, but not in SM. There were no time-by-group effects on DPBs. DPBs decreased in the CBT2go condition but not in SM. These results indicated that single intervention augmented by mobile intervention was feasible and associated with small yet sustained effects on global psychopathology and, when inclusive of CBT, community function compared with usual care.",2019,"These results indicated that single intervention augmented by mobile intervention was feasible and associated with small yet sustained effects on global psychopathology and, when inclusive of CBT, community function compared with usual care.","['Serious Mental Illness', '255 individuals diagnosed with schizophrenia or bipolar disorder']","['Psychosocial interventions', 'Single-Session Mobile-Augmented Intervention', 'CBT2go, which combined one individual session of cognitive behavioral therapy with automated thought challenging/adaptive behavior delivered through mobile devices; Self-Monitoring (SM), which combined single-session illness psychoeducation with self-monitoring of symptoms; and treatment-as-usual (TAU', 'CBT2go']","['DPBs', 'active conditions (CBT2go and SM) relative to TAU', 'global psychopathology', 'global psychopathology (Brief Psychiatric Rating Scale-expanded version [BPRS-24]), and secondary outcomes community functioning (Specific Level of Function; SLOF) and defeatist performance beliefs (DPBs', 'SLOF scores', 'BPRS Total score']","[{'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C0085880', 'cui_str': 'Behavior, Adaptive'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0029941', 'cui_str': 'Overall and Gorham Brief Psychiatric Rating Scale'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",255.0,0.282854,"These results indicated that single intervention augmented by mobile intervention was feasible and associated with small yet sustained effects on global psychopathology and, when inclusive of CBT, community function compared with usual care.","[{'ForeName': 'Colin A', 'Initials': 'CA', 'LastName': 'Depp', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego, CA.'}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Perivoliotis', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego, CA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Holden', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego, CA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Dorr', 'Affiliation': 'Psychology Department, VA San Diego Healthcare System, San Diego, CA.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Granholm', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego, CA.'}]",Schizophrenia bulletin,['10.1093/schbul/sby135']
920,31907755,Bystander Program Effectiveness to Reduce Violence and Violence Acceptance Within Sexual Minority Male and Female High School Students Using a Cluster RCT.,"Bystander interventions have been highlighted as promising strategies to reduce sexual violence and sexual harassment, yet their effectiveness for sexual minority youth remains largely unexamined in high schools' populations. This rigorous cluster randomized control trial addresses this gap by evaluating intervention effectiveness among sexual majority and minority students known be to at increased risk of sexual violence. Kentucky high schools were randomized to intervention or control conditions. In intervention schools, educators provided school-wide Green Dot presentations (phase 1) and intensive bystander training to student popular opinion leaders (phase 2). Each spring from 2010 to 2014, students attending 26 high schools completed anonymous surveys about violence acceptance and violent events. An analytic sample of 74,836 surveys with no missing data over the 5 years was available. Sexual violence acceptance scores declined significantly over time in intervention versus control schools among all but sexual minority males. This intervention was also associated with reductions in both perpetration and victimization of sexual violence, sexual harassment, and physical dating violence among sexual majority yet not sexual minority youth. Both sexual minority and majority youth experienced reductions in stalking victimization and perpetration associated with the intervention. In this large cluster randomized controlled trial, the bystander intervention appears to work best to reduce violence for sexual majority youth. Bystander programs may benefit from explicitly engaging sexual minority youth in intervention efforts or adapting intervention programs to include attitudes that shape the experience of sexual minority high school youth (e.g., homophobic teasing, homonegativity).",2020,"This intervention was also associated with reductions in both perpetration and victimization of sexual violence, sexual harassment, and physical dating violence among sexual majority yet not sexual minority youth.","['Sexual Minority Male and Female High School Students Using a Cluster RCT', '74,836 surveys with no missing data over the 5\xa0years was available', 'Kentucky high schools', 'sexual majority youth', 'Each spring from 2010 to 2014, students attending 26 high schools completed anonymous surveys about violence acceptance and violent events']","['bystander intervention', 'intensive bystander training', 'Bystander interventions']","['perpetration and victimization of sexual violence, sexual harassment, and physical dating violence', 'Sexual violence acceptance scores', 'Violence and Violence Acceptance']","[{'cui': 'C4277573', 'cui_str': 'Sexual and Gender Minorities'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0022557', 'cui_str': 'Kentucky'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0242151', 'cui_str': 'Violent'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C3489576', 'cui_str': 'Sexual Violence'}, {'cui': 'C0162790', 'cui_str': 'Sexual Harrassment'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",26.0,0.0276991,"This intervention was also associated with reductions in both perpetration and victimization of sexual violence, sexual harassment, and physical dating violence among sexual majority yet not sexual minority youth.","[{'ForeName': 'Ann L', 'Initials': 'AL', 'LastName': 'Coker', 'Affiliation': 'University of Kentucky College of Medicine, 800 Rose St., Pavilion H, Room C361, Lexington, KY, 40536, USA. ann.coker@uky.edu.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Bush', 'Affiliation': 'University of Kentucky College of Public Health, Lexington, KY, USA.'}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Clear', 'Affiliation': 'University of Kentucky College of Public Health, Lexington, KY, USA.'}, {'ForeName': 'Candace J', 'Initials': 'CJ', 'LastName': 'Brancato', 'Affiliation': 'University of Kentucky College of Public Health, Lexington, KY, USA.'}, {'ForeName': 'Heather L', 'Initials': 'HL', 'LastName': 'McCauley', 'Affiliation': 'Michigan State University, School of Social Work, East Lansing, MI, 48824, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-019-01073-7']
921,31438861,A comparison between the Disposcope endoscope and fibreoptic bronchoscope for nasotracheal intubation: a randomized controlled trial.,"BACKGROUND


Nasotracheal intubation (NTI) is frequently performed for oral and maxillofacial surgeries. This study evaluated whether NTI is easier when guided by Disposcope endoscopy or fibreoptic bronchoscopy.
METHODS


Sixty patients (30 per group) requiring NTI were randomly assigned to undergo fibreoptic bronchoscopy-guided (fibreoptic group) or Disposcope endoscope-guided (Disposcope group) NTI. The NTI time, which was defined as the time from when the fibreoptic bronchoscope or aseptic suction catheter was inserted into the nasal cavity to the time at which the tracheal tube was correctly inserted through the glottis, was recorded. Epistaxis was evaluated by direct laryngoscopy five minutes after completing NTI and was scored as one of four grades according to the following modified criteria: no epistaxis, mild epistaxis, moderate epistaxis, and severe epistaxis.
RESULTS


The time to complete NTI was significantly longer in the fibreoptic group than in the Disposcope group (38.4 s vs 24.1 s; mean difference, 14.2 s; 95% confidence interval (CI), 10.4 to 18.1). Mild epistaxis was observed in 8 patients in the fibreoptic group and in 7 patients in the Disposcope group (26.7% vs 23.3%, respectively; relative risk, 1.2; 95% CI, 0.4 to 3.9), though no moderate or severe epistaxis occurred in either group. Furthermore, no obvious nasal pain was reported by any of the patients at any time point after extubation (P = 0.74).
CONCLUSION


NTI can be completed successfully using either fibreoptic bronchoscopy or Disposcope endoscope as a guide without any severe complications. However, compared to fibreoptic bronchoscopy, Disposcope endoscope requires less execution time (the NTI time).
TRIAL REGISTRATION


This clinical research was registered at the Chinese Clinical Trial Registry ( www.chictr.org.cn , ChiCTR-IPR-17011462, date of registration, May 2017).",2019,"The time to complete NTI was significantly longer in the fibreoptic group than in the Disposcope group (38.4 s vs 24.1 s; mean difference, 14.2 s; 95% confidence interval (CI), 10.4 to 18.1).","['Sixty patients (30 per group) requiring NTI', 'nasotracheal intubation']","['Nasotracheal intubation (NTI', 'fibreoptic bronchoscopy or Disposcope endoscope', 'fibreoptic bronchoscopy-guided (fibreoptic group) or Disposcope endoscope-guided (Disposcope group) NTI', 'Disposcope endoscope and fibreoptic bronchoscope', 'NTI', 'fibreoptic bronchoscopy, Disposcope endoscope']","['Epistaxis', 'execution time', 'severe epistaxis', 'Mild epistaxis', 'time to complete NTI', 'obvious nasal pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation (procedure)'}]","[{'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation (procedure)'}, {'cui': 'C0189391', 'cui_str': 'Fiberoptic bronchoscopy (procedure)'}, {'cui': 'C0014243', 'cui_str': 'Endoscopes'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0179433', 'cui_str': 'Flexible bronchoscope (physical object)'}]","[{'cui': 'C0014591', 'cui_str': 'Nosebleed'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0240564', 'cui_str': 'Pain of nose (finding)'}]",60.0,0.119594,"The time to complete NTI was significantly longer in the fibreoptic group than in the Disposcope group (38.4 s vs 24.1 s; mean difference, 14.2 s; 95% confidence interval (CI), 10.4 to 18.1).","[{'ForeName': 'Junma', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': ""Hefei National Laboratory for Physical Sciences at the Microscale, Department of Biophysics and Neurobiology, University of Science and Technology of China, Hefei, 230027, People's Republic of China. majuny163@163.com.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Hu', 'Affiliation': ""Department of Anesthesiology, The First People's Hospital of Hefei, Anhui Medical University, Hefei, Anhui, 230061, People's Republic of China.""}, {'ForeName': 'Lining', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': ""Department of Anesthesiology, The First People's Hospital of Hefei, Anhui Medical University, Hefei, Anhui, 230061, People's Republic of China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Sun', 'Affiliation': ""Department of Anesthesiology, The First People's Hospital of Hefei, Anhui Medical University, Hefei, Anhui, 230061, People's Republic of China.""}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ""Hefei National Laboratory for Physical Sciences at the Microscale, Department of Biophysics and Neurobiology, University of Science and Technology of China, Hefei, 230027, People's Republic of China.""}]",BMC anesthesiology,['10.1186/s12871-019-0834-3']
922,27881624,An acceptance and commitment therapy self-help intervention for carers of patients in palliative care: Protocol of a feasibility randomised controlled trial.,"Undertaking a caregiving role at end of life can have enduring psychological consequences for carers, including poor adjustment in bereavement. Acceptance and commitment therapy-based interventions have demonstrated effectiveness in helping people cope with a range of life challenges. This article presents the protocol of a feasibility randomised controlled trial of an acceptance and commitment therapy self-help intervention for psychological distress and grief in carers of patients in palliative care. We will assess feasibility and acceptability of the trial procedures and intervention as well as preliminary effectiveness of the intervention on carer well-being outcomes.",2019,"Undertaking a caregiving role at end of life can have enduring psychological consequences for carers, including poor adjustment in bereavement.","['psychological distress and grief in carers of patients in palliative care', 'carers of patients in palliative care']",['acceptance and commitment therapy self-help intervention'],[],"[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0018235', 'cui_str': 'Grief'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",[],,0.101001,"Undertaking a caregiving role at end of life can have enduring psychological consequences for carers, including poor adjustment in bereavement.","[{'ForeName': 'Esther L', 'Initials': 'EL', 'LastName': 'Davis', 'Affiliation': '1 University of Wollongong, Australia.'}, {'ForeName': 'Frank P', 'Initials': 'FP', 'LastName': 'Deane', 'Affiliation': '1 University of Wollongong, Australia.'}, {'ForeName': 'Geoffrey Cb', 'Initials': 'GC', 'LastName': 'Lyons', 'Affiliation': '2 Australian College of Applied Psychology, Australia.'}]",Journal of health psychology,['10.1177/1359105316679724']
923,32022945,A Daily Study Comparing Alcohol-Related Positive and Negative Consequences for Days With Only Alcohol Use Versus Days With Simultaneous Alcohol and Marijuana Use in a Community Sample of Young Adults.,"BACKGROUND


Alcohol and marijuana are psychoactive substances commonly used by young adults and are independently associated with numerous acute and long-term consequences. Many young adults engage in simultaneous alcohol and marijuana (SAM) use to cross-fade (i.e., to enhance the effects of intoxication), although the extent to which alcohol use and alcohol-related consequences increase on SAM occasions compared to alcohol-only occasions is unclear. This study examines daily data among a sample of SAM users comparing SAM days to other days when young adults only used alcohol.
METHODS


A sample of 409 young adults (age 18 to 25; M age   = 21.6, SD = 2.2; 50.9% women) who reported SAM use in the past month completed 2 bursts of 14 days of daily surveys (28 days in total) assessing alcohol use, alcohol-related consequences, and SAM use.
RESULTS


Multilevel models based on alcohol-only and SAM days (n = 3,016 days; 391 individuals) indicated young adults drank more alcohol on SAM days compared to alcohol-only days (with no marijuana use). Similarly, days with SAM use were associated with more alcohol-related positive and negative consequences. The daily association between SAM use and positive consequences was statistically significant, after accounting for the amount of alcohol consumed; in contrast, the association between SAM use and negative consequences was diminished and nonsignificant.
CONCLUSIONS


Among young adult SAM users, days with SAM use were associated with more alcohol use and positive consequences compared to days they only drank alcohol. Further examination of the motivational context for engaging in SAM use, as well as potential physiological interactions between alcohol and marijuana use on alcohol's effects, is warranted. Alcohol interventions might benefit from addressing increased alcohol use and alcohol-related consequences as risks associated with SAM use.",2020,"3,016 days; 391 individuals) indicated young adults drank more alcohol on SAM days compared to alcohol-only days (with no marijuana use).","['409 young adults (age 18 to 25; M age  \xa0=\xa021.6, SD\xa0=\xa02.2; 50.9% women) who reported SAM use in the past month completed 2 bursts of 14\xa0days of daily surveys (28\xa0days in total) assessing alcohol use, alcohol-related consequences, and SAM use', 'young adults only used alcohol', 'Young Adults']",['Alcohol interventions'],['SAM use and negative consequences'],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1563296', 'cui_str': 'Systolic anterior movement of mitral valve'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C1563296', 'cui_str': 'Systolic anterior movement of mitral valve'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]",409.0,0.0174366,"3,016 days; 391 individuals) indicated young adults drank more alcohol on SAM days compared to alcohol-only days (with no marijuana use).","[{'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Lee', 'Affiliation': 'From the, Department of Psychiatry and Behavioral Sciences, (CML, CBF, JMC, DAA, AMF, MEL), University of Washington, Seattle, Washington.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Patrick', 'Affiliation': ""Institute for Translational Research in Children's Mental Health and Institute of Child Development, (MEP), University of Minnesota, Minneapolis, Minnesota.""}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Fleming', 'Affiliation': 'From the, Department of Psychiatry and Behavioral Sciences, (CML, CBF, JMC, DAA, AMF, MEL), University of Washington, Seattle, Washington.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Cadigan', 'Affiliation': 'From the, Department of Psychiatry and Behavioral Sciences, (CML, CBF, JMC, DAA, AMF, MEL), University of Washington, Seattle, Washington.'}, {'ForeName': 'Devon A', 'Initials': 'DA', 'LastName': 'Abdallah', 'Affiliation': 'From the, Department of Psychiatry and Behavioral Sciences, (CML, CBF, JMC, DAA, AMF, MEL), University of Washington, Seattle, Washington.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Fairlie', 'Affiliation': 'From the, Department of Psychiatry and Behavioral Sciences, (CML, CBF, JMC, DAA, AMF, MEL), University of Washington, Seattle, Washington.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Larimer', 'Affiliation': 'From the, Department of Psychiatry and Behavioral Sciences, (CML, CBF, JMC, DAA, AMF, MEL), University of Washington, Seattle, Washington.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14279']
924,31473867,Low-level laser therapy for weight reduction: a randomized pilot study.,"Obesity and overweight is a global health crisis and novel methods of treatment are needed to address it. Low-level laser therapy (LLLT) is a currently available non-invasive procedure for lysing excess fat, but there is a lack of consensus exists on LLLT frequency and limited research from studies of LLLT. The purpose of this pilot study is to compare the effect of three of the most common LLLT frequencies on weight, waist circumference, body fat percentage, and quality of life. Sixty overweight (body mass index (BMI) 25-29.9 kg/m 2 ) adult participants were randomized to 12 LLLT treatments: (1) three times weekly for 4 weeks, (2) twice weekly for 6 weeks, or (3) once weekly for 12 weeks. All participants attended an in-person visit at baseline and at weeks 4, 6, 12, and 26. Participants were recruited September 30, 2016 through to August 27, 2017. The majority of the 60 participants were female (90%) with an average age of 43.7 years (± 9.2 years). Most participants (98%) completed 10 or more of the 12 LLLT treatments. When comparing across treatment groups, the greatest reductions from baseline were observed in those assigned to twice weekly for 6 weeks in weight (1 ± 1.7 (±SD) kg by week 6), waist circumference (- 2.0 ± 3.2 in. by week 6 and - 1.5 ± 3.2 in. by week 26), body mass index (- 0.4 ± 0.6 kg/m 2 ), and body fat mass (- 1.1 ± 1.6 kg). This group also had the most significant improvement from baseline in quality of life (+ 0.5 ± 0.8 by week 6), body satisfaction (+ 0.2 ± 0.4 by week 6 and week 26), and body appreciation (+ 0.2 ± 0.3 by week 6 and + 0.3 ± 0.3 by week 26). LLLT twice weekly for 6 weeks could be proposed as the optimal frequency and duration for the management of body weight. Trial registration: https://clinicaltrials.gov/ct2/show/NCT02877004. Registered August 24, 2016.",2020,"This group also had the most significant improvement from baseline in quality of life (+ 0.5 ± 0.8 by week 6), body satisfaction (+ 0.2 ± 0.4 by week 6 and week 26), and body appreciation (+ 0.2 ± 0.3 by week 6 and + 0.3 ± 0.3 by week 26).","['Sixty overweight (body mass index (BMI) 25-29.9\xa0kg/m 2 ) adult participants', 'All participants attended an in-person visit at baseline and at weeks 4, 6, 12, and 26', 'Participants were recruited September 30, 2016 through to August 27, 2017', '60 participants were female (90%) with an average age of 43.7\xa0years (±\u20099.2\xa0years']","['Low-level laser therapy', 'LLLT', 'Low-level laser therapy (LLLT']","['body satisfaction', 'quality of life', 'weight, waist circumference, body fat percentage, and quality of life']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332273', 'cui_str': 'Through (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0279027', 'cui_str': 'Low-Power Laser Therapy'}, {'cui': 'C4019433', 'cui_str': 'LLLT'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034380'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}]",60.0,0.0657926,"This group also had the most significant improvement from baseline in quality of life (+ 0.5 ± 0.8 by week 6), body satisfaction (+ 0.2 ± 0.4 by week 6 and week 26), and body appreciation (+ 0.2 ± 0.3 by week 6 and + 0.3 ± 0.3 by week 26).","[{'ForeName': 'Ivana T', 'Initials': 'IT', 'LastName': 'Croghan', 'Affiliation': 'Department of Medicine, Division of Community Internal Medicine and Clinical Research Office and Center of Science and Health Care Delivery, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA. croghan.ivana@mayo.edu.'}, {'ForeName': 'Ryan T', 'Initials': 'RT', 'LastName': 'Hurt', 'Affiliation': 'Department of Medicine, Division of General Internal Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Darrell R', 'Initials': 'DR', 'LastName': 'Schroeder', 'Affiliation': 'Department of Health Sciences Research, Division of Biomedical Statistics and Informatics, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Shawn C', 'Initials': 'SC', 'LastName': 'Fokken', 'Affiliation': 'Department of Medicine Clinical Research Office, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Jensen', 'Affiliation': 'Department of Medicine, Division of Endocrinology and Metabolic Disease, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Matthew M', 'Initials': 'MM', 'LastName': 'Clark', 'Affiliation': 'Department Department of Psychiatry and Psychology, and Division of Endocrinology and Metabolic Disease, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Jon O', 'Initials': 'JO', 'LastName': 'Ebbert', 'Affiliation': 'Department of Medicine, Division of Community Internal Medicine, Department of Medicine, and Center for the Science of Health Care Delivery, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.'}]",Lasers in medical science,['10.1007/s10103-019-02867-5']
925,31127076,Comparison between physical and cognitive treatment in patients with MCI and Alzheimer's disease.,"Cognitive and physical activity treatments (CT and PT) are two non-pharmacological approaches frequently used in patients with Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD). The aim of this study was to compare CT and PT in these diseases. Eighty-seven patients were randomly assigned to CT (n=30), PT (n=27) or control group (CTRL; n=30) for 6 months. The global cognitive function was measured by Mini Mental State Examination (MMSE). Specific neuropsychological tests explored attention, memory, executive functions, behavioral disorders. Cardiovascular risk factors (CVD) were collected. All measures were performed before (T0), after treatments (T1), and at three-months follow-up (T2). MMSE did not change from T0 to T1 and T2 in patients assigned to PT and CT, while CTRL patients showed a decline MCI: -11.8%, AD: -16.2%). Between group differences (MCI vs AD) were not found at T1 and T2. Significant worsening was found for CTRL in MCI (T0- T1:  P =.039; T0-T2:  P <.001) and AD (T0-T1:  P <.001; T0-T2:  P <.001), and amelioration was found for CT in AD (T0-T2:  P <.001). Attention, executive functions and behavioral disorders were unaffected by either PT or CT. Memory was increased in patients with MCI assigned to PT (+6.9%) and CT (+8.5%).. CVD were ameliorated in the PT group. CTRL patients of both groups, revealed significant decline in all functions and no between groups differences were detected. PT appear to ameliorate CVD. Although between groups differences were not found, results suggest a major retention in MCI compared with AD, suggesting that the latter might benefit better of constant rather than periodic treatments. This study confirms the positive effects of CT and PT in mitigating the cognitive decline in MCI and AD patients, and it is the first to demonstrate their similar effectiveness on maintaining cognitive function.",2019,"Significant worsening was found for CTRL in MCI (T0- T1:  P =.039; T0-T2:  P <.001) and AD (T0-T1:  P <.001; T0-T2:  P <.001), and amelioration was found for CT in AD (T0-T2:  P <.001).","['MCI and AD patients', ""patients with MCI and Alzheimer's disease"", 'Eighty-seven patients', ""patients with Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD""]","['MMSE', 'control group (CTRL', 'Cognitive and physical activity treatments (CT and PT', 'CT', 'CT and PT', 'CTRL']","['Attention, executive functions and behavioral disorders', 'Memory', 'CVD', 'Cardiovascular risk factors (CVD', 'Mini Mental State Examination (MMSE', 'global cognitive function', 'Specific neuropsychological tests explored attention, memory, executive functions, behavioral disorders']","[{'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C4517895', 'cui_str': 'Eighty-seven'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}]","[{'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0004930', 'cui_str': 'Behavior Disorders'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychologic Tests'}]",87.0,0.0164615,"Significant worsening was found for CTRL in MCI (T0- T1:  P =.039; T0-T2:  P <.001) and AD (T0-T1:  P <.001; T0-T2:  P <.001), and amelioration was found for CT in AD (T0-T2:  P <.001).","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Fonte', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Centre, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Smania', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Centre, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Pedrinolla', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Munari', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Centre, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Marialuisa', 'Initials': 'M', 'LastName': 'Gandolfi', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Centre, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Picelli', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Centre, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Varalta', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Centre, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Maria V', 'Initials': 'MV', 'LastName': 'Benetti', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Brugnera', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Federico', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Ettore', 'Initials': 'E', 'LastName': 'Muti', 'Affiliation': 'Mons. A. Mazzali Foundation, Mantua, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Tamburin', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Schena', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Venturelli', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}]",Aging,['10.18632/aging.101970']
926,31655359,DNA epigenetic signature predictive of benefit from neoadjuvant chemotherapy in oesophageal adenocarcinoma: results from the MRC OE02 trial.,"BACKGROUND


DNA methylation signatures describing distinct histological subtypes of oesophageal cancer have been reported. We studied DNA methylation in samples from the MRC OE02 phase III trial, which randomised patients with resectable oesophageal cancer to surgery alone (S) or neoadjuvant chemotherapy followed by surgery (CS).
AIM


The aim of the study was to identify epigenetic signatures predictive of chemotherapy benefit in patients with oesophageal adenocarcinoma (OAC) from the OE02 trial and validate the findings in an independent cohort.
METHODS


DNA methylation was analysed using the Illumina GoldenGate platform on surgically resected OAC specimens from patients in the OE02 trial. Cox proportional hazard analysis was performed to select probes predictive of survival in the CS arm. Non-negative matrix factorisation was used to perform clustering and delineate DNA methylation signatures. The findings were validated in an independent cohort of patients with gastroesophageal adenocarcinoma treated with neoadjuvant chemotherapy.
RESULTS


A total of 229 patients with OAC were analysed from the OE02 trial (118 in the CS arm and 111 in the S arm). There was no difference in DNA methylation status between the CS and S arms. A metagene signature was created by dichotomising samples into two clusters. In cluster 1, patients in the CS arm had significant overall survival (OS) benefit (median OS CS: 931 days vs. S: 536 days [HR: 1.54, P = 0.031]). In cluster 2, patients in the CS arm had similar (or worse) OS compared with patients in the S arm (CS: 348 days vs. S: 472 days [HR: 0.70, P = 0.1], and test of interaction was significant (p = 0.005). In the validation cohort (n = 13), there was no difference in DNA methylation status in paired pre- and post-treatment samples. When the epigenetic signature was applied, cluster 1 samples had better OS (median OS, cluster 1: 1174 days vs. cluster 2: 392 days, HR: 3.47, p = 0.059) CONCLUSIONS: This is the first and largest study of DNA methylation in patients with OAC uniformly treated in a randomised phase III trial. We identified an epigenetic signature that may serve as a predictive biomarker for chemotherapy benefit in OAC.",2019,"When the epigenetic signature was applied, cluster 1 samples had better OS (median OS, cluster 1: 1174 days vs. cluster 2: 392 days, HR: 3.47, p = 0.059)","['229 patients with OAC were analysed from the OE02 trial (118 in the CS arm and 111\xa0in the S arm', 'oesophageal adenocarcinoma', 'patients with resectable oesophageal cancer to surgery alone (S) or neoadjuvant chemotherapy followed by surgery (CS', 'patients with OAC', 'patients with gastroesophageal adenocarcinoma treated with neoadjuvant chemotherapy', 'patients with oesophageal adenocarcinoma (OAC', 'surgically resected OAC specimens from\xa0patients in the OE02 trial']",['neoadjuvant chemotherapy'],"['DNA methylation status', 'overall survival (OS) benefit']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0303403', 'cui_str': 'Indium-111'}, {'cui': 'C0279628', 'cui_str': 'Adenocarcinoma Of Esophagus'}, {'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0376452', 'cui_str': 'DNA Methylation'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",229.0,0.148295,"When the epigenetic signature was applied, cluster 1 samples had better OS (median OS, cluster 1: 1174 days vs. cluster 2: 392 days, HR: 3.47, p = 0.059)","[{'ForeName': 'Raghav', 'Initials': 'R', 'LastName': 'Sundar', 'Affiliation': 'Department of Haematology-Oncology, National University Health System, Singapore; Cancer and Stem Cell Biology Program, Duke-NUS Medical School, Singapore; Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Ng', 'Affiliation': 'Cancer and Stem Cell Biology Program, Duke-NUS Medical School, Singapore; Centre for Computational Biology, Duke-NUS Medical School, Singapore; NUS Graduate School for Integrative Sciences and Engineering, Singapore.'}, {'ForeName': 'Hermioni', 'Initials': 'H', 'LastName': 'Zouridis', 'Affiliation': 'Cancer and Stem Cell Biology Program, Duke-NUS Medical School, Singapore; Technology Innovation and Delivery Excellence, AstraZeneca, USA.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Padmanabhan', 'Affiliation': 'Cancer and Stem Cell Biology Program, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Taotao', 'Initials': 'T', 'LastName': 'Sheng', 'Affiliation': 'Cancer and Stem Cell Biology Program, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Shenli', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Cancer and Stem Cell Biology Program, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Ming Hui', 'Initials': 'MH', 'LastName': 'Lee', 'Affiliation': 'Cancer and Stem Cell Biology Program, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Wen Fong', 'Initials': 'WF', 'LastName': 'Ooi', 'Affiliation': 'Cancer and Stem Cell Biology Program, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Aditi', 'Initials': 'A', 'LastName': 'Qamra', 'Affiliation': 'Cancer and Stem Cell Biology Program, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Inam', 'Affiliation': ""Division of Pathology and Data Analytics, Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}, {'ForeName': 'Lindsay C', 'Initials': 'LC', 'LastName': 'Hewitt', 'Affiliation': 'Department of Pathology, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Center+, Maastricht, the Netherlands.'}, {'ForeName': 'Jimmy Bok-Yan', 'Initials': 'JB', 'LastName': 'So', 'Affiliation': 'Department of Surgery, National University Health System, Singapore; Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Vivien', 'Initials': 'V', 'LastName': 'Koh', 'Affiliation': 'Department of Haematology-Oncology, National University Health System, Singapore; Cancer Science Institute of Singapore, National University of Singapore, Singapore.'}, {'ForeName': 'Matthew G', 'Initials': 'MG', 'LastName': 'Nankivell', 'Affiliation': 'MRC Clinical Trials Unit at University College London, London, UK.'}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Langley', 'Affiliation': 'MRC Clinical Trials Unit at University College London, London, UK.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Allum', 'Affiliation': 'Department of Surgery, Royal Marsden Hospital, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'Department of Medicine, The Royal Marsden NHS Trust, London and Sutton, United Kingdom.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Rozen', 'Affiliation': 'Centre for Computational Biology, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Wei Peng', 'Initials': 'WP', 'LastName': 'Yong', 'Affiliation': 'Department of Haematology-Oncology, National University Health System, Singapore; Cancer Science Institute of Singapore, National University of Singapore, Singapore.'}, {'ForeName': 'Heike I', 'Initials': 'HI', 'LastName': 'Grabsch', 'Affiliation': ""Division of Pathology and Data Analytics, Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK; Department of Pathology, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Center+, Maastricht, the Netherlands. Electronic address: h.grabsch@maastrichtuniversity.nl.""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Tan', 'Affiliation': 'Cancer and Stem Cell Biology Program, Duke-NUS Medical School, Singapore; Cancer Science Institute of Singapore, National University of Singapore, Singapore; Biomedical Research Council, Agency for Science, Technology and Research, Singapore; SingHealth/Duke-NUS Institute of Precision Medicine, National Heart Centre Singapore, Singapore. Electronic address: gmstanp@duke-nus.edu.sg.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.09.016']
927,31665727,Toward Preventing Enamel Hypoplasia: Modeling Maternal and Neonatal Biomarkers of Human Calcium Homeostasis.,"AIM


The aim of this study was to assess biomarkers of calcium homeostasis and tooth development, in mothers during pregnancy and their children at birth, for enamel hypoplasia (EH) in the primary maxillary central incisor teeth.
METHODS


Bayesian methodology was used for secondary data analyses from a randomized, controlled trial of prenatal vitamin D3 supplementation in healthy mothers (N = 350) and a follow-up study of a subset of the children. The biomarkers were serum calcium (Ca), phosphorus (P), intact parathyroid hormone (iPTH), total circulating 25-dihydroxyvitamin D (25(OH)D), and 1,25-dihydroxyvitamin D (1,25(OH)2D). The maternal biomarkers were assayed monthly during pregnancy, and the child's biomarkers were derived from cord blood. Digital images of the child's 2 teeth were scored for EH using Enamel Defects Index criteria for each of the incisal, middle, and cervical regions for an EH extent score.
RESULTS


The child EH prevalence was 41% (60/145), with most defects present in the incisal and middle tooth regions. Cord blood iPTH and 1,25(OH)2D levels were significantly associated with EH extent after controlling for maternal factors. For every 1 pg/mL increase in cord blood iPTH, the EH extent decreased by approximately 6%. For every 10 pg/mL increase in cord blood 1,25(OH)2D, the EH extent increased by almost 30% (holding all other terms constant and adjusting for subject-level heterogeneity). The relationship between maternal 25(OH)D and maternal mean iPTH varied significantly by EH extent.
CONCLUSION


The results suggest possible modifiable relationships of maternal and neonatal factors of calcium homeostasis during pregnancy and at birth for EH, contributing to the frontier of knowledge regarding sound tooth development for dental caries prevention.",2020,"Cord blood iPTH and 1,25(OH)2D levels were significantly associated with EH extent after controlling for maternal factors.","['mothers during pregnancy and their children at birth, for enamel hypoplasia (EH) in the primary maxillary central incisor teeth', 'healthy mothers (N = 350) and a follow-up study of a subset of the children']",['prenatal vitamin D3 supplementation'],"['serum calcium (Ca), phosphorus (P), intact parathyroid hormone (iPTH), total circulating 25-dihydroxyvitamin D (25(OH)D), and 1,25-dihydroxyvitamin D (1,25(OH)2D', 'cord blood 1,25(OH)2D, the EH extent', 'cord blood iPTH, the EH extent', 'child EH prevalence', 'Cord blood iPTH and 1,25(OH)2D levels', 'maternal 25(OH)D and maternal mean iPTH']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0011351', 'cui_str': 'Enamel Hypoplasia'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0021156', 'cui_str': 'Incisor'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0772413', 'cui_str': 'Prenatal vitamin'}]","[{'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0012328', 'cui_str': 'Dihydroxyvitamins D'}, {'cui': 'C0370232', 'cui_str': '1,25-dihydroxyvitamin D'}, {'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0047008', 'cui_str': 'IPTHS'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",350.0,0.0416406,"Cord blood iPTH and 1,25(OH)2D levels were significantly associated with EH extent after controlling for maternal factors.","[{'ForeName': 'Susan G', 'Initials': 'SG', 'LastName': 'Reed', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston, South Carolina, USA, reedsg@musc.edu.'}, {'ForeName': 'Cameron S', 'Initials': 'CS', 'LastName': 'Miller', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Carol L', 'Initials': 'CL', 'LastName': 'Wagner', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Hollis', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Lawson', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.'}]",Caries research,['10.1159/000502793']
928,31806540,"Olaparib in patients with metastatic castration-resistant prostate cancer with DNA repair gene aberrations (TOPARP-B): a multicentre, open-label, randomised, phase 2 trial.","BACKGROUND


Metastatic castration-resistant prostate cancer is enriched in DNA damage response (DDR) gene aberrations. The TOPARP-B trial aims to prospectively validate the association between DDR gene aberrations and response to olaparib in metastatic castration-resistant prostate cancer.
METHODS


In this open-label, investigator-initiated, randomised phase 2 trial following a selection (or pick-the-winner) design, we recruited participants from 17 UK hospitals. Men aged 18 years or older with progressing metastatic castration-resistant prostate cancer previously treated with one or two taxane chemotherapy regimens and with an Eastern Cooperative Oncology Group performance status of 2 or less had tumour biopsies tested with targeted sequencing. Patients with DDR gene aberrations were randomly assigned (1:1) by a computer-generated minimisation method, with balancing for circulating tumour cell count at screening, to receive 400 mg or 300 mg olaparib twice daily, given continuously in 4-week cycles until disease progression or unacceptable toxicity. Neither participants nor investigators were masked to dose allocation. The primary endpoint of confirmed response was defined as a composite of all patients presenting with any of the following outcomes: radiological objective response (as assessed by Response Evaluation Criteria in Solid Tumors 1.1), a decrease in prostate-specific antigen (PSA) of 50% or more (PSA50) from baseline, or conversion of circulating tumour cell count (from ≥5 cells per 7·5 mL blood at baseline to <5 cells per 7·5 mL blood). A confirmed response in a consecutive assessment after at least 4 weeks was required for each component. The primary analysis was done in the evaluable population. If at least 19 (43%) of 44 evaluable patients in a dose cohort responded, then the dose cohort would be considered successful. Safety was assessed in all patients who received at least one dose of olaparib. This trial is registered at ClinicalTrials.gov, NCT01682772. Recruitment for the trial has completed and follow-up is ongoing.
FINDINGS


711 patients consented for targeted screening between April 1, 2015, and Aug 30, 2018. 161 patients had DDR gene aberrations, 98 of whom were randomly assigned and treated (49 patients for each olaparib dose), with 92 evaluable for the primary endpoint (46 patients for each olaparib dose). Median follow-up was 24·8 months (IQR 16·7-35·9). Confirmed composite response was achieved in 25 (54·3%; 95% CI 39·0-69·1) of 46 evaluable patients in the 400 mg cohort, and 18 (39·1%; 25·1-54·6) of 46 evaluable patients in the 300 mg cohort. Radiological response was achieved in eight (24·2%; 11·1-42·3) of 33 evaluable patients in the 400 mg cohort and six (16·2%; 6·2-32·0) of 37 in the 300 mg cohort; PSA50 response was achieved in 17 (37·0%; 23·2-52·5) of 46 and 13 (30·2%; 17·2-46·1) of 43; and circulating tumour cell count conversion was achieved in 15 (53·6%; 33·9-72·5) of 28 and 13 (48·1%; 28·7-68·1) of 27. The most common grade 3-4 adverse event in both cohorts was anaemia (15 [31%] of 49 patients in the 300 mg cohort and 18 [37%] of 49 in the 400 mg cohort). 19 serious adverse reactions were reported in 13 patients. One death possibly related to treatment (myocardial infarction) occurred after 11 days of treatment in the 300 mg cohort.
INTERPRETATION


Olaparib has antitumour activity against metastatic castration-resistant prostate cancer with DDR gene aberrations, supporting the implementation of genomic stratification of metastatic castration-resistant prostate cancer in clinical practice.
FUNDING


Cancer Research UK, AstraZeneca, Prostate Cancer UK, the Prostate Cancer Foundation, the Experimental Cancer Medicine Centres Network, and the National Institute for Health Research Biomedical Research Centres.",2020,"Confirmed composite response was achieved in 25 (54·3%; 95% CI 39·0-69·1) of 46 evaluable patients in the 400 mg cohort, and 18 (39·1%; 25·1-54·6) of 46 evaluable patients in the 300 mg cohort.","['recruited participants from 17 UK hospitals', '161 patients had DDR gene aberrations, 98 of whom were randomly assigned and treated (49 patients for each olaparib dose), with 92 evaluable for the primary endpoint (46 patients for each olaparib dose', 'Patients with DDR gene aberrations', 'metastatic castration-resistant prostate cancer', 'patients with metastatic castration-resistant prostate cancer with DNA repair gene aberrations (TOPARP-B', 'Men aged 18 years or older with progressing metastatic castration-resistant prostate cancer previously treated with one or two taxane chemotherapy regimens and with an Eastern Cooperative Oncology Group performance status of 2 or less had tumour biopsies tested with targeted sequencing', '711 patients consented for targeted screening between April 1, 2015, and Aug 30, 2018']",['Olaparib'],"['prostate-specific antigen (PSA) of 50% or more (PSA50) from baseline, or conversion of circulating tumour cell count', 'anaemia', 'PSA50 response', 'Radiological response', 'radiological objective response', '19 serious adverse reactions', 'circulating tumour cell count conversion', 'Safety', 'composite response']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0012899', 'cui_str': 'DNA Repair'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C2316164', 'cui_str': 'olaparib'}]","[{'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant (morphologic abnormality)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}]",711.0,0.409267,"Confirmed composite response was achieved in 25 (54·3%; 95% CI 39·0-69·1) of 46 evaluable patients in the 400 mg cohort, and 18 (39·1%; 25·1-54·6) of 46 evaluable patients in the 300 mg cohort.","[{'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Mateo', 'Affiliation': ""The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UK; Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.""}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Porta', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Diletta', 'Initials': 'D', 'LastName': 'Bianchini', 'Affiliation': 'The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'McGovern', 'Affiliation': 'University College Hospital, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Elliott', 'Affiliation': 'The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'University of Glasgow and Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Syndikus', 'Affiliation': 'The Clatterbridge Cancer Centre, Wirral, UK.'}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Ralph', 'Affiliation': ""St James's Institute of Oncology, University of Leeds, Leeds, UK.""}, {'ForeName': 'Suneil', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': ""Queen's University, Belfast, UK.""}, {'ForeName': 'Mohini', 'Initials': 'M', 'LastName': 'Varughese', 'Affiliation': 'Musgrove Park Hospital, Taunton, UK.'}, {'ForeName': 'Omi', 'Initials': 'O', 'LastName': 'Parikh', 'Affiliation': 'Royal Blackburn Hospital, Blackburn, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Crabb', 'Affiliation': 'University of Southampton, Southampton, UK.'}, {'ForeName': 'Angus', 'Initials': 'A', 'LastName': 'Robinson', 'Affiliation': 'Royal Sussex County Hospital, Brighton, UK.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'McLaren', 'Affiliation': 'Western General Hospital, Edinburgh, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Birtle', 'Affiliation': 'Royal Lancaster Infirmary, Lancaster, UK.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Tanguay', 'Affiliation': 'Velindre Cancer Centre, Cardiff, UK.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Miranda', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Figueiredo', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Seed', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Bertan', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Flohr', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Berni', 'Initials': 'B', 'LastName': 'Ebbs', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Rescigno', 'Affiliation': 'The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Fowler', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ferreira', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Riisnaes', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Pereira', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Andra', 'Initials': 'A', 'LastName': 'Curcean', 'Affiliation': 'The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Chandler', 'Affiliation': 'The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Clarke', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Bora', 'Initials': 'B', 'LastName': 'Gurel', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Mateus', 'Initials': 'M', 'LastName': 'Crespo', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Nava Rodrigues', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Shahneen', 'Initials': 'S', 'LastName': 'Sandhu', 'Affiliation': 'Peter McCallum Cancer Center, Melbourne, VIC, Australia.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Espinasse', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Chatfield', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Tunariu', 'Affiliation': 'The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yuan', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Carreira', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Johann S', 'Initials': 'JS', 'LastName': 'de Bono', 'Affiliation': 'The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UK. Electronic address: johann.de-bono@icr.ac.uk.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30684-9']
929,30758491,Effect of Augmenting Standard Care for Military Personnel With Brief Caring Text Messages for Suicide Prevention: A Randomized Clinical Trial.,"Importance


Accessible and cost-effective interventions for suicidality are needed to address high rates of suicidal behavior among military service members. Caring Contacts are brief periodic messages that express unconditional care and concern and have been previously shown to prevent suicide deaths, attempts, ideation, and hospitalizations.
Objective


To test the effectiveness of augmenting standard military health care with Caring Contacts delivered via text message to reduce suicidal thoughts and behaviors over 12 months.
Design, Setting, and Participants


This randomized clinical trial was conducted at 3 military installations in the southern and western United States. Soldiers and Marines identified as being at risk of suicide were recruited between April 2013 and September 2016. The final follow-up was in September 2017.
Interventions


Both groups received standard care, and the Caring Contacts group also received consisted of 11 text messages delivered on day 1, at week 1, at months 1, 2, 3, 4, 6, 8, 10, and 12, and on participants' birthdays.
Main Outcomes and Measures


Primary outcomes were current suicidal ideation and suicide risk incidents (hospitalization or medical evacuation). Secondary outcomes were worst-point suicidal ideation, emergency department visits, and suicide attempts. Suicidal ideation was measured by the Scale for Suicide Ideation, suicide risk incidents, and emergency department visits by the Treatment History Interview; attempted suicide was measured by the Suicide Attempt Self-Injury Count.
Results


Among 658 randomized participants (329 randomizely assigned to each group), data were analyzed for 657 individuals (mean [SD] age, 25.2 [6.1] years; 539 men [82.0%]). All participants reported suicidal ideation at baseline, and 291 (44.3%) had previously attempted suicide. Of the 657 participants, 461 (70.2%) were assessed at 12 months. Primary outcomes were nonsignificant. There was no significant effect on likelihood or severity of current suicidal ideation or likelihood of a suicide risk incident; there was also no effect on emergency department visits. However, participants who received Caring Contacts (172 of 216 participants [79.6%]) had lower odds than those receiving standard care alone (179 of 204 participants [87.7%]) of experiencing any suicidal ideation between baseline and follow-up (odds ratio, 0.56 [95% CI, 0.33-0.95]; P = .03) and fewer had attempted suicide since baseline (21 of 233 [9.0%] in the group receiving Caring Contacts vs 34 of 228 [14.9%] in the standard-care group; odds ratio, 0.52 [95% CI, 0.29-0.92]; P = .03).
Conclusions and Relevance


This trial provides inconsistent results on the effectiveness of caring text messages between primary and secondary outcomes, but this inexpensive and scalable intervention offers promise for preventing suicide attempts and ideation in military personnel. Additional research is needed.
Trial Registration


ClinicalTrials.gov identifier: NCT01829620.",2019,There was no significant effect on likelihood or severity of current suicidal ideation or likelihood of a suicide risk incident; there was also no effect on emergency department visits.,"['657 individuals (mean [SD] age, 25.2 [6.1] years', '658 randomized participants (329 randomizely assigned to each group', 'Suicide Prevention', 'Military Personnel', '539 men [82.0', '657 participants, 461 (70.2%) were assessed at 12 months', '3 military installations in the southern and western United States']",[],"['worst-point suicidal ideation, emergency department visits, and suicide attempts', 'likelihood or severity of current suicidal ideation', 'Suicidal ideation', 'attempted suicide since baseline', 'current suicidal ideation and suicide risk incidents (hospitalization or medical evacuation', 'suicidal thoughts and behaviors', 'Scale for Suicide Ideation, suicide risk incidents, and emergency department visits', 'suicidal ideation']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0204732', 'cui_str': 'Suicide prevention (procedure)'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",[],"[{'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt (event)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0563664', 'cui_str': 'Suicide risk'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0222045'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0392348', 'cui_str': 'Ideation, function (observable entity)'}]",658.0,0.195533,There was no significant effect on likelihood or severity of current suicidal ideation or likelihood of a suicide risk incident; there was also no effect on emergency department visits.,"[{'ForeName': 'Katherine Anne', 'Initials': 'KA', 'LastName': 'Comtois', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, School of Medicine, University of Washington, Seattle.'}, {'ForeName': 'Amanda H', 'Initials': 'AH', 'LastName': 'Kerbrat', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, School of Medicine, University of Washington, Seattle.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'DeCou', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, School of Medicine, University of Washington, Seattle.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Atkins', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, School of Medicine, University of Washington, Seattle.'}, {'ForeName': 'Justine J', 'Initials': 'JJ', 'LastName': 'Majeres', 'Affiliation': 'Womack Army Medical Center, Fort Bragg, North Carolina.'}, {'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'Baker', 'Affiliation': 'Naval Medical Center Camp Lejeune, Camp Lejeune, North Carolina.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Ries', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, School of Medicine, University of Washington, Seattle.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2018.4530']
930,32075611,Rehabilitation coordinator intervention versus control in psychiatric specialist care for return to work and reduced sick leave: study protocol of a randomised controlled trial.,"BACKGROUND


Mental disorders are the most common reason for sick leave in Sweden. Knowledge about effective methods to help these individuals to return to work (RTW)/entry into work or studies is limited. Rehabilitation coordinators (RC's) have been introduced within healthcare with the purpose to promote cooperation, streamline the sick leave and rehabilitation process, and facilitate RTW for sick-listed patients. The function of RC's has shown positive results by reducing sick leave within primary healthcare. However, the function has not been evaluated in terms of specialist psychiatry. This paper describes the design of a study to evaluate effects of a RC intervention on sick leave and RTW/entry in work or studies in patients with moderate to severe affective and/or moderate to severe anxiety disorders within specialist psychiatric care.
METHODS


A randomised controlled trial (RCT) comparing an intervention group receiving support from a RC with a control group receiving treatment as usual (TAU). The target group is patients on sick leave, treated for affective and/or anxiety disorder, aged 25-64, with or without employment.
DISCUSSION


This study gives the possibility to evaluate a RC intervention for individuals with mental disorders. If the study has promising vocational outcomes, it may be of importance for the participants in many ways, e.g. increase participation in society, provide economic benefits and improve health and wellbeing. This would be valuable for the individual as well as for the society.
TRIAL REGISTRATION


The study is registered at the Clinicaltrials.gov Register Platform (ID NCT03729050) in 2 November 2018.",2020,"This paper describes the design of a study to evaluate effects of a RC intervention on sick leave and RTW/entry in work or studies in patients with moderate to severe affective and/or moderate to severe anxiety disorders within specialist psychiatric care.
","['patients on sick leave, treated for affective and/or anxiety disorder, aged 25-64, with or without employment', 'individuals with mental disorders', 'patients with moderate to severe affective and/or moderate to severe anxiety disorders within specialist psychiatric care']","['RC intervention', 'Rehabilitation coordinator intervention', 'intervention group receiving support from a RC with a control group receiving treatment as usual (TAU']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0041674', 'cui_str': 'Unemployment'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}]","[{'cui': 'C4708571', 'cui_str': 'Rehabilitation coordinator (occupation)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]",[],,0.142769,"This paper describes the design of a study to evaluate effects of a RC intervention on sick leave and RTW/entry in work or studies in patients with moderate to severe affective and/or moderate to severe anxiety disorders within specialist psychiatric care.
","[{'ForeName': 'Åsa', 'Initials': 'Å', 'LastName': 'Andersén', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala University, P.O Box 564, SE-751 22, Uppsala, Sweden. asa.andersen@pubcare.uu.se.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Berglund', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala University, P.O Box 564, SE-751 22, Uppsala, Sweden.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Anderzén', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala University, P.O Box 564, SE-751 22, Uppsala, Sweden.'}]",BMC public health,['10.1186/s12889-020-8238-3']
931,31152038,"Proteostasis and ALS: protocol for a phase II, randomised, double-blind, placebo-controlled, multicentre clinical trial for colchicine in ALS (Co-ALS).","INTRODUCTION


Disruptions of proteasome and autophagy systems are central events in amyotrophic lateral sclerosis (ALS) and support the urgent need to find therapeutic compounds targeting these processes. The heat shock protein B8 (HSPB8) recognises and promotes the autophagy-mediated removal of misfolded mutant SOD1 and TDP-43 fragments from ALS motor neurons (MNs), as well as aggregating species of dipeptides produced in C9ORF72-related diseases. In ALS-SOD1 mice and in human ALS autopsy specimens, HSPB8 is highly expressed in spinal cord MNs that survive at the end stage of disease. Moreover, the HSPB8-BAG3-HSP70 complex maintains granulostasis, which avoids conversion of dynamic stress granules (SGs) into aggregation-prone assemblies. We will perform a randomised clinical trial (RCT) with colchicine, which enhances the expression of HSPB8 and of several autophagy players, blocking TDP-43 accumulation and exerting crucial activities for MNs function.
METHODS AND ANALYSIS


Colchicine in amyotrophic lateral sclerosis (Co-ALS) is a double-blind, placebo-controlled, multicentre, phase II RCT. ALS patients will be enrolled in three groups (placebo, colchicine 0.01 mg/day and colchicine 0.005 mg/day) of 18 subjects treated with riluzole; treatment will last 30 weeks, and follow-up will last 24 weeks. The primary aim is to assess whether colchicine decreases disease progression as measured by ALS Functional Rating Scale - Revised (ALSFRS-R) at baseline and at treatment end. Secondary aims include assessment of (1) safety and tolerability of Colchicine in patiets with ALS; (2) changes in cellular activity (autophagy, protein aggregation, and SG and exosome secretion) and in biomarkers of disease progression (neurofilaments); (3) survival and respiratory function and (4) quality of life. Preclinical studies with a full assessment of autophagy and neuroinflammation biomarkers in fibroblasts, peripheral blood mononuclear cells and lymphoblasts will be conducted in parallel with clinic assessment to optimise time and resources.
ETHICS AND DISSEMINATION


The study protocol was approved by the Ethics Committee of Area Vasta Emilia Nord and by Agenzia Italiana del Farmaco (EUDRACT N.2017-004459-21) based on the Declaration of Helsinki. This research protocol was written without patient involvement. Patients' association will be involved in disseminating the study design and results. Results will be presented during scientific symposia or published in scientific journals.
TRIAL REGISTRATION NUMBER


EUDRACT 2017-004459-21 ;  NCT03693781; Pre-results.",2019,"The heat shock protein B8 (HSPB8) recognises and promotes the autophagy-mediated removal of misfolded mutant SOD1 and TDP-43 fragments from ALS motor neurons (MNs), as well as aggregating species of dipeptides produced in C9ORF72-related diseases.","['amyotrophic lateral sclerosis (Co-ALS', '18 subjects treated with', 'ALS patients', 'amyotrophic lateral sclerosis (ALS']","['placebo', 'placebo, colchicine', 'Colchicine', 'colchicine', 'riluzole']","['cellular activity (autophagy, protein aggregation, and SG and exosome secretion) and in biomarkers of disease progression (neurofilaments); (3) survival and respiratory function and (4) quality of life', 'assessment of (1) safety and tolerability', 'ALS Functional Rating Scale - Revised (ALSFRS-R']","[{'cui': 'C0002736', 'cui_str': 'ALS (Amyotrophic Lateral Sclerosis)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0073379', 'cui_str': 'Riluzole'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0004391', 'cui_str': 'Cellular Autophagies'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0332621', 'cui_str': 'Aggregation (finding)'}, {'cui': 'C2350332', 'cui_str': 'Exosomes'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0034380'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0222045'}]",,0.139337,"The heat shock protein B8 (HSPB8) recognises and promotes the autophagy-mediated removal of misfolded mutant SOD1 and TDP-43 fragments from ALS motor neurons (MNs), as well as aggregating species of dipeptides produced in C9ORF72-related diseases.","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Mandrioli', 'Affiliation': 'Department of Neurosciences, St. Agostino Estense Hospital, Azienda Ospedaliero Universitaria di Modena, Modena, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Crippa', 'Affiliation': 'Dipartimento di Scienze Farmacologiche e Biomolecolari, Centro di Eccellenza sulle Malattie Neurodegenerative, Università degli Studi di Milano, Milano, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Cereda', 'Affiliation': 'Genomics and Post-Genomics Center, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Bonetto', 'Affiliation': 'Laboratory of Translational Biomarkers, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Zucchi', 'Affiliation': 'Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Gessani', 'Affiliation': 'Department of Neurosciences, St. Agostino Estense Hospital, Azienda Ospedaliero Universitaria di Modena, Modena, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Ceroni', 'Affiliation': 'Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Adriano', 'Initials': 'A', 'LastName': 'Chio', 'Affiliation': '""Rita Levi Montalcini"" Departmentof Neurosciences, ALS Centre, University of Turin and Azienda Ospedaliero Universitaria Città della Salute e della Scienza, Turin, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': ""D'Amico"", 'Affiliation': 'Department of Diagnostic, Clinical and Public Health Medicine, University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': 'Maria Rosaria', 'Initials': 'MR', 'LastName': 'Monsurrò', 'Affiliation': 'Dipartimento ad attività integratedi Medicina Interna e Specialistica, Azienda Ospedaliero Universitaria ""L. Vanvitelli"", Napoli, Italy.'}, {'ForeName': 'Nilo', 'Initials': 'N', 'LastName': 'Riva', 'Affiliation': 'Department of Neurology, Institute of Experimental Neurology (INSPE), Division of Neuroscience, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Sabatelli', 'Affiliation': 'Neuromuscular Omni Centre (NEMO), Fondazione Serena Onlus, Policlinico A. Gemelli IRCCS, Roma, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Silani', 'Affiliation': 'Department of Neurology-Stroke Unitand Laboratory of Neuroscience, Istituto Auxologico Italiano IRCCS, Milan, Italy.'}, {'ForeName': 'Isabella Laura', 'Initials': 'IL', 'LastName': 'Simone', 'Affiliation': 'Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari, Bari, Italy.'}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Sorarù', 'Affiliation': 'Department of Neurosciences, University of Padua, Padua, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Provenzani', 'Affiliation': 'Centre of Integrative Biology (CIBIO), University of Trento, Trento, Italy.'}, {'ForeName': 'Vito Giuseppe', 'Initials': 'VG', 'LastName': ""D'Agostino"", 'Affiliation': 'Centre of Integrative Biology (CIBIO), University of Trento, Trento, Italy.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Carra', 'Affiliation': 'Centre for Neuroscience and Nanotechnology, Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Poletti', 'Affiliation': 'Dipartimento di Scienze Farmacologiche e Biomolecolari, Centro di Eccellenza sulle Malattie Neurodegenerative, Università degli Studi di Milano, Milano, Italy.'}]",BMJ open,['10.1136/bmjopen-2018-028486']
932,32147337,Cortical suture button fixation vs. bicortical screw fixation in the Latarjet procedure: a biomechanical comparison.,"BACKGROUND


The Latarjet procedure traditionally has been performed with 2 screws in an open manner. Recently, cortical suture button fixation for coracoid transfer has been used in hopes of mitigating complications seen with screw placement. The aim of this study was to evaluate a cortical suture button and technique currently available in the United States compared with screw fixation in the Latarjet procedure in a cadaveric model.
METHODS


We randomly assigned 9 matched pairs of fresh-frozen cadaveric shoulders (N = 18) to undergo the Latarjet procedure with either screw fixation or cortical suture button fixation. After fixation, all shoulders underwent biomechanical testing with direct loading on the graft vas a material testing system. Cyclic testing was performed for 100 cycles to determine axial displacement with time; each graft was then monotonically loaded to failure.
RESULTS


The maximum cycle displacement was significantly less for screw fixation vs. cortical suture button fixation (3.1 ± 1.3 mm vs. 8.9 ± 2.1 mm, P < .0001). The total load at failure was 481.1 ± 88.8 N for screws and 175.5 ± 95.8 N for cortical suture buttons (P < .0001). Bony damage to the surrounding anatomy was more extensive at failure in the screw-fixation group.
CONCLUSION


At time zero, the cortical button fixation and technique did not resist direct loads to the graft as much as traditional screw fixation, although bony damage to the surrounding anatomy was more extensive in screw fixation than button fixation. In the event of unanticipated loading, this could place a patient at higher risk of graft migration, which could lead to unintended early outcomes. These results support the need for implants and techniques specifically tailored to the Latarjet procedure and should bring into question the adoption of a cortical button and technique not specific to the procedure.",2020,"At time zero, the cortical button fixation and technique did not resist direct loads to the graft as much as traditional screw fixation, although bony damage to the surrounding anatomy was more extensive in screw fixation than button fixation.",[],"['fresh-frozen cadaveric shoulders (N = 18) to undergo the Latarjet procedure with either screw fixation or cortical suture button fixation', 'Cortical suture button fixation vs.\xa0bicortical screw fixation', 'cortical suture button and technique', 'screw fixation']","['maximum cycle displacement', 'total load at failure']",[],"[{'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C3697075', 'cui_str': 'Latarjet procedure'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0183717', 'cui_str': 'Suture button, device (physical object)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",9.0,0.0337111,"At time zero, the cortical button fixation and technique did not resist direct loads to the graft as much as traditional screw fixation, although bony damage to the surrounding anatomy was more extensive in screw fixation than button fixation.","[{'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Williams', 'Affiliation': 'Department of Orthopaedic Surgery and Rehabilitation, The University of Texas Medical Branch, Galveston, TX, USA.'}, {'ForeName': 'Randal P', 'Initials': 'RP', 'LastName': 'Morris', 'Affiliation': 'Department of Orthopaedic Surgery and Rehabilitation, The University of Texas Medical Branch, Galveston, TX, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'El Beaino', 'Affiliation': 'Department of Orthopaedic Surgery and Rehabilitation, The University of Texas Medical Branch, Galveston, TX, USA.'}, {'ForeName': 'Nicholas H', 'Initials': 'NH', 'LastName': 'Maassen', 'Affiliation': 'Inov8 Orthopedics, Houston, TX, USA. Electronic address: nickmaass@gmail.com.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2019.11.025']
933,32147329,Colour change of ceramic brackets with the use of coloured beverages in adolescent patients: A randomized clinical trial.,"OBJECTIVE


To clinically evaluate colour change of ceramic orthodontic brackets with the use of coloured beverages as ceramic brackets' resistance to discoloration has become a major concern.
MATERIAL AND METHODS


A prospective two parallel groups-split mouth randomized trial with a 1:1 allocation ratio. Two equal groups including 40 adolescent patients from the orthodontic department (Faculty of Dentistry, Mansoura University, Egypt), scheduled for maxillary premolar extractions were bonded with 2 types of mono-crystalline ceramic brackets: Type 1 (Inspire ICETM) and Type 2 (Radiance PlusTM). Participants in each group were asked to rinse with either black tea or Cola. After extraction, the colour of the 80 debonded brackets was compared to that of 20 control brackets from each type by spectrophotometer according to the international standard CIELAB colour space (CIE L*a*b*). The latter consists of three coordinates: L* (lightness value), a* and b* (the colour channels). The total colour difference ΔE* is the distance between two colours in this three-dimensional colour space. The colour change was also assessed by digital image analysis according to the RGB model.
RESULTS


Type 1 brackets showed mean ΔE* values of 2.24±0.25 in black tea and 1.76±0.1 in Cola groups (P<0.001), while Type 2 brackets showed means of 1.99±0.15 in black tea and 1.56±0.1 in Cola groups (P<0.001). The mean RGB values were 174.3±12.02 in black tea and 185.6±6.9 in the Cola groups of type 1 brackets (P<0.001), while were 166.5±17.8 in black tea and 190.8±8.9 in Cola groups of type 2 brackets (P<0.001).
CONCLUSION


Black tea showed more significant effect than Cola on the two bracket types. Bracket type affected the colour change in each beverage group.",2020,Bracket type affected the colour change in each beverage group.,"['40 adolescent patients from the orthodontic department (Faculty of Dentistry, Mansoura University, Egypt), scheduled for maxillary premolar extractions were bonded with 2 types of mono-crystalline ceramic brackets: Type 1 (Inspire ICETM) and Type 2 (Radiance PlusTM', 'adolescent patients']","['Black tea', 'rinse with either black tea or Cola']",['mean RGB values'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0587511', 'cui_str': 'Orthodontics department (environment)'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0011438', 'cui_str': 'Dentistry'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0013715', 'cui_str': 'Arab Republic of Egypt'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}, {'cui': 'C0007742', 'cui_str': 'Ceramics'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C0452440', 'cui_str': 'Black Tea'}, {'cui': 'C0684195', 'cui_str': 'Cola'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",40.0,0.106843,Bracket type affected the colour change in each beverage group.,"[{'ForeName': 'Adnan M', 'Initials': 'AM', 'LastName': 'Shibani', 'Affiliation': 'Mansoura University, Faculty of Dentistry, Orthodontic Department, Mansoura, Egypt.'}, {'ForeName': 'Marwa Sameh', 'Initials': 'MS', 'LastName': 'Shamaa', 'Affiliation': 'Mansoura University, Faculty of Dentistry, Orthodontic Department, Mansoura, Egypt.'}, {'ForeName': 'Mona A', 'Initials': 'MA', 'LastName': 'Montasser', 'Affiliation': 'Mansoura University, Faculty of Dentistry, Orthodontic Department, Mansoura, Egypt. Electronic address: mmontasser11@yahoo.com.'}]",International orthodontics,['10.1016/j.ortho.2020.02.002']
934,32060881,Effects of Family-Centered Media Literacy Training on Family Nutrition Outcomes.,"Parents frustrated about food marketing influences need media management skills to challenge marketing messages and interpret factual content. We tested a media literacy-based, family-centered intervention to reduce effects of appealing, but unrealistic, food marketing. We hypothesized that participation would facilitate family discussion that improves the home dietary environment and increases youth consumption of fruits and vegetables. Parent-child (age 9-14) dyads (N = 189) participated in a matched-group, pretest/posttest field experiment testing a 6-week media literacy-based curriculum. Hypothesis testing employed multiple analysis of covariance and Bayesian multigroup structural equation modeling (MGSEM). Improved nutrition outcomes for parents included talk with youth about food nutrition labels (d = 0.343) and ratio of healthy to unhealthy food in home (d = 0.232); youth improved talk with parent about food nutrition labels (d = 0.211), vegetables eaten yesterday (d = 0.264), and fruit eaten yesterday (d = 1.386). Bayesian MGSEM revealed that in the intervention group, 12 of 17 tested paths were significant (p < .05), compared with only 4 in the control group, with average effect size magnitudes of 0.236 and 0.113, respectively. Media literacy education can empower parents and improve youths' critical thinking to reduce negative effects of food marketing on families and improve use of media to obtain nutrition information that aids dietary choices. This approach reduces the risk for reactance from youth who like media and resist limiting media use, while helping families use media together to make better nutrition decisions.",2020,"Bayesian MGSEM revealed that in the intervention group, 12 of 17 tested paths were significant (p < .05), compared with only 4 in the control group, with average effect size magnitudes of 0.236 and 0.113, respectively.","['dyads', 'Parent-child (age 9-14']","['Family-Centered Media Literacy Training', 'Media literacy education', 'media literacy-based, family-centered intervention']","['Improved nutrition outcomes', 'Family Nutrition Outcomes']","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0015576', 'cui_str': 'Family'}]",189.0,0.0225344,"Bayesian MGSEM revealed that in the intervention group, 12 of 17 tested paths were significant (p < .05), compared with only 4 in the control group, with average effect size magnitudes of 0.236 and 0.113, respectively.","[{'ForeName': 'Erica Weintraub', 'Initials': 'EW', 'LastName': 'Austin', 'Affiliation': 'Edward R. Murrow Center for Media & Health Promotion Research, Edward R. Murrow College of Communication, Goertzen Communication Addition 101, Washington State University, Mail Code 2520, Pullman, WA, 99164-2520, USA. eaustin@wsu.edu.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Austin', 'Affiliation': 'Department of Kinesiology and Educational Psychology, Washington State University, Mail Code 2136, Pullman, WA, 99164-2136, USA.'}, {'ForeName': 'C Kit', 'Initials': 'CK', 'LastName': 'Kaiser', 'Affiliation': 'Edward R. Murrow Center for Media & Health Promotion Research, Edward R. Murrow College of Communication, Goertzen Communication Addition 101, Washington State University, Mail Code 2520, Pullman, WA, 99164-2520, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01101-x']
935,31924632,"Postoperative intravenous parecoxib sodium followed by oral celecoxib post total knee arthroplasty in osteoarthritis patients (PIPFORCE): a multicentre, double-blind, randomised, placebo-controlled trial.","OBJECTIVES


To evaluate the morphine-sparing effects of the sequential treatment versus placebo in subjects undergoing total knee arthroplasty (TKA), the effects on pain relief, inflammation control and functional rehabilitation after TKA and safety.
DESIGN


Double-blind, pragmatic, randomised, placebo-controlled trial.
SETTING


Four tertiary hospitals in China.
PARTICIPANTS


246 consecutive patients who underwent elective unilateral TKA because of osteoarthritis (OA).
INTERVENTIONS


Patients were randomised 1:1 to the parecoxib/celecoxib group or the control group. The patients in the parecoxib/celecoxib group were supplied sequential treatment with intravenous parecoxib 40 mg (every 12 hours) for the first 3 days after surgery, followed by oral celecoxib 200 mg (every 12 hours) for up to 6 weeks. The patients in the control group were supplied with the corresponding placebo under the same instructions.
PRIMARY AND SECONDARY OUTCOME MEASURES


The primary endpoint was the cumulative opioid consumption at 2 weeks post operation (intention-to-treat analysis). Secondary endpoints included the Knee Society Score, patient-reported outcomes and the cumulative opioid consumption.
RESULTS


The cumulative opioid consumption at 2 weeks was significantly smaller in the parecoxib/celecoxib group than in the control group (median difference, 57.31 (95% CI 34.66 to 110.33)). The parecoxib/celecoxib group achieving superior Knee Society Scores and EQ-5D scores and greater Visual Analogue Scale score reduction during 6 weeks. Interleukin 6, erythrocyte sedation rate and C-reactive protein levels were reduced at 72 hours, 2 weeks and 4 weeks and prostaglandin E2 levels were reduced at 48 hours and 72 hours in the parecoxib/celecoxib group compared with the placebo group. The occurrence of adverse events (AEs) was significantly lower in the parecoxib/celecoxib group.
CONCLUSIONS


The sequential intravenous parecoxib followed by oral celecoxib regimen reduces morphine consumption, achieves better pain control and functional recovery and leads to less AEs than placebo after TKA for OA.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov (ID: NCT02198924).",2020,"Interleukin 6, erythrocyte sedation rate and C-reactive protein levels were reduced at 72 hours, 2 weeks and 4 weeks and prostaglandin E2 levels were reduced at 48 hours and 72 hours in the parecoxib/celecoxib group compared with the placebo group.","['Four tertiary hospitals in China', 'post total knee arthroplasty in osteoarthritis patients (PIPFORCE', '246 consecutive patients who underwent elective unilateral TKA because of osteoarthritis (OA', 'subjects undergoing total knee arthroplasty (TKA']","['celecoxib', 'morphine', 'parecoxib sodium followed by oral celecoxib', 'parecoxib', 'placebo', 'parecoxib/celecoxib']","['occurrence of adverse events (AEs', 'Knee Society Score, patient-reported outcomes and the cumulative opioid consumption', 'pain relief, inflammation control and functional rehabilitation after TKA and safety', 'cumulative opioid consumption', 'superior Knee Society Scores and EQ-5D scores and greater Visual Analogue Scale score reduction', 'Interleukin 6, erythrocyte sedation rate and C-reactive protein levels', 'prostaglandin E2 levels', 'pain control and functional recovery and leads to less AEs', 'morphine consumption']","[{'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}]","[{'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0915144', 'cui_str': 'parecoxib sodium'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0915142', 'cui_str': 'parecoxib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0454532', 'cui_str': 'Functional rehabilitation (regime/therapy)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0012472', 'cui_str': 'prostaglandin E2 alpha'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]",246.0,0.674506,"Interleukin 6, erythrocyte sedation rate and C-reactive protein levels were reduced at 72 hours, 2 weeks and 4 weeks and prostaglandin E2 levels were reduced at 48 hours and 72 hours in the parecoxib/celecoxib group compared with the placebo group.","[{'ForeName': 'Qianyu', 'Initials': 'Q', 'LastName': 'Zhuang', 'Affiliation': 'Department of Orthopedics, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Liyuan', 'Initials': 'L', 'LastName': 'Tao', 'Affiliation': 'Research Center of Clinical Epidemiology, Peking University 3rd Hospital, Beijing, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Orthopedics, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': 'Department of Orthopedics, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Wenwei', 'Initials': 'W', 'LastName': 'Qian', 'Affiliation': 'Department of Orthopedics, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Bian', 'Affiliation': 'Department of Orthopedics, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Yulong', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Yulei', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Department of Orthopedics, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Huiming', 'Initials': 'H', 'LastName': 'Peng', 'Affiliation': 'Department of Orthopedics, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Department of Orthopedics, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Feng', 'Affiliation': 'Department of Orthopedics, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Gao', 'Affiliation': 'Department of Orthopedics, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Tiezheng', 'Initials': 'T', 'LastName': 'Sun', 'Affiliation': 'Department of Orthopedics, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Jianhao', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Orthopedics, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Miaofeng', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedics, The Second Affiliated Hospital of Zhejiang University, Zhejiang, China.'}, {'ForeName': 'Shigui', 'Initials': 'S', 'LastName': 'Yan', 'Affiliation': 'Department of Orthopedics, The Second Affiliated Hospital of Zhejiang University, Zhejiang, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Shen', 'Affiliation': 'Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Fuxing', 'Initials': 'F', 'LastName': 'Pei', 'Affiliation': 'Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xisheng', 'Initials': 'X', 'LastName': 'Weng', 'Affiliation': 'Department of Orthopedics, Peking Union Medical College Hospital, Beijing, China wengxishengpumch@126.com.'}]",BMJ open,['10.1136/bmjopen-2019-030501']
936,31924637,A town level comprehensive intervention study to reduce salt intake in China: protocol for a cluster randomised controlled trial.,"INTRODUCTION


Salt intake in China (≈12 g/day) is more than twice the upper limit recommended by the WHO (5 g/day). To reduce salt intake, Action on Salt China (ASC) was launched in 2017. As one of four randomised controlled trials (RCTs) in the ASC programme, a comprehensive intervention study was designed to test whether all the components of the interventions adopted by other RCTs are acceptable, scalable and effective when provided to a region in the real world.
METHODS AND ANALYSIS


Using a cluster RCT design, 2688 participants were selected from 48 towns (clusters) in 12 counties in 6 provinces and assigned to the intervention group or the control group. Randomisation was performed after the baseline survey was completed. Information on salt-related knowledge, attitude and practice (KAP), blood pressure and 24-hour urinary sodium were collected. The intervention includes government engagement, health education and other intervention components targeting restaurants, home cooks and primary school students and their families that have been used in other RCTs. The control group will not receive the intervention. The project will be followed up for 2 years, with the intervention being carried out for the first year only. The primary outcome is salt intake measured by 24-hour urinary sodium excretion after 1 year. The secondary outcomes are the long-lasting effectiveness on salt intake and blood pressure measured by the same method, as well as salt-related KAP and blood pressure at the 1-year and 2-year follow-ups. Process evaluation and health economics analysis will be conducted as well.
ETHICS AND DISSEMINATION


The study was reviewed and approved by the Institutional Review Board of the National Center for Chronic and Noncommunicable Disease Control and Prevention, the Chinese Center for Disease Control and Prevention, and Queen Mary Research Ethics Committee. Results will be disseminated through presentations, publications and social media.
TRIAL REGISTRATION NUMBER


ChiCTR1800018119.",2020,"Information on salt-related knowledge, attitude and practice (KAP), blood pressure and 24-hour urinary sodium were collected.",['2688 participants were selected from 48 towns (clusters) in 12 counties in 6 provinces and assigned to the intervention group or the control group'],"['government engagement, health education and other intervention components targeting restaurants, home cooks and primary school students and their families that have been used in other RCTs']","['salt-related knowledge, attitude and practice (KAP), blood pressure and 24-hour urinary sodium', 'salt intake, Action on Salt China (ASC', 'long-lasting effectiveness on salt intake and blood pressure measured by the same method, as well as salt-related KAP and blood pressure', 'salt intake measured by 24-hour urinary sodium excretion']","[{'cui': 'C0557750', 'cui_str': 'Towns'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0018701'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0035255', 'cui_str': 'Restaurants'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1306756', 'cui_str': 'Cook (occupation)'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}]",2688.0,0.0469492,"Information on salt-related knowledge, attitude and practice (KAP), blood pressure and 24-hour urinary sodium were collected.","[{'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'National Center for Chronic and Noncommunicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Biwei', 'Initials': 'B', 'LastName': 'Tang', 'Affiliation': 'National Center for Chronic and Noncommunicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'National Center for Chronic and Noncommunicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Yamin', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'National Center for Chronic and Noncommunicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': 'Jiangxi Provincial Center for Disease Control and Prevention, Nanchang, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Heilongjiang Provincial Center for Disease Control and Prevention, Harbin, China.'}, {'ForeName': 'Zhihua', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Qinghai Provincial Center for Disease Control and Prevention, Xining, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Sichuan Provincial Center for Disease Control and Prevention, Chengdu, China.'}, {'ForeName': 'Donghui', 'Initials': 'D', 'LastName': 'Jin', 'Affiliation': 'Hunan Provincial Center for Disease Control and Prevention, Changsha, China.'}, {'ForeName': 'Jixin', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Hebei Provincial Center for Disease Control and Prevention, Shijiazhuang, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Peking University Health Science Centre, The George Institute for Global Health, Beijing, China.'}, {'ForeName': 'Feng J', 'Initials': 'FJ', 'LastName': 'He', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Graham A', 'Initials': 'GA', 'LastName': 'MacGregor', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'National Center for Chronic and Noncommunicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China wujingcdc@163.com zpuhong@georgeinstitute.org.cn.'}, {'ForeName': 'Puhong', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Diabetes Program, The George Institute at Peking University Health Science Center, Beijing, China wujingcdc@163.com zpuhong@georgeinstitute.org.cn.'}]",BMJ open,['10.1136/bmjopen-2019-032976']
937,31421670,Effects of a metabolic optimized fast track concept (MOFA) on bowel function and recovery after surgery in patients undergoing elective colon or liver resection: a randomized controlled trial.,"BACKGROUND


Enhanced recovery after surgery programs (ERAS) using thoracic epidural anesthesia and perioperative patient conditioning with omega-3 fatty acids (n3FA), glucose control (GC) and on-demand fluid therapy, respectively, showed beneficial effects. In the MOFA- study these components were used together in patients undergoing colon or liver surgery. We hypothesized that the use of a perioperative MOFA program improves intestine function represented as time to the first postoperative bowel movement in adult patients compared to standard ERAS.
METHODS


After BfArM and IRB approval 100 patients were enrolled in this prospective randomized controlled trial. All patients received ERAS therapy (control). In addition, the MOFA group received 0.2 g/kg fish oil (Omegaven®), preoperatively, followed by a 48 h continuous infusion of 0.2 g/kg/d n3FA; and GC was kept below < 8 mmol/L. Pre- and postoperatively energy drinks were administered.
RESULTS


As compared to control group the MOFA concept resulted in an earlier onset of flatulence by 14 h (46.6 ± 25.7, 32.0 ± 17.9, p = 0.030, hours, control vs. MOFA, respectively). Effects on onset of bowel movement were not observed (74.5 ± 30.4, 66.4 ± 29.2, p = 0.163, hours, control vs. MOFA, respectively). The disease severity (SAPS II score; p = 0.720) as well as deployment of resources (TISS 28 score, p = 0.709) did not differ between groups. No statistic significant difference between MOFA and control group regarding inflammation, impairment of coagulation, length of hospital stay or incidence of postoperative surgical complications were observed.
CONCLUSIONS


The MOFA concept did not result in an improvement of intestine function or faster recovery after elective colon or liver surgery compared to standard ERAS therapy. Omega-3 fatty acids showed no impairment of coagulation or improved resolution of inflammation. Further trials in a larger patient collective are needed to investigate potential beneficial effects of omega-3 fatty acids in abdominal surgery.
TRIAL REGISTRATION


This trial was prospectively registered at the European Union Clinical Trials Register (EuDraCT 2005-004814-33, date: 10-05-2005, https://www.clinicaltrialsregister.eu/ctr-search/search?query=2005-004814-33+ ).",2019,"No statistic significant difference between MOFA and control group regarding inflammation, impairment of coagulation, length of hospital stay or incidence of postoperative surgical complications were observed.
","['100 patients', 'patients undergoing elective colon or liver resection', 'European Union Clinical Trials Register (EuDraCT 2005-004814-33, date: 10-05-2005, https://www.clinicaltrialsregister.eu/ctr-search/search?query=2005-004814-33+ ', 'patients undergoing colon or liver surgery']","['metabolic optimized fast track concept (MOFA', 'omega-3 fatty acids', 'MOFA', 'omega-3 fatty acids (n3FA), glucose control (GC', 'ERAS therapy (control', 'perioperative MOFA program', 'Omega-3 fatty acids']","['intestine function', 'inflammation, impairment of coagulation, length of hospital stay or incidence of postoperative surgical complications', 'impairment of coagulation or improved resolution of inflammation', 'onset of bowel movement', 'earlier onset of flatulence']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0015179', 'cui_str': 'European Community'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}]",100.0,0.0998297,"No statistic significant difference between MOFA and control group regarding inflammation, impairment of coagulation, length of hospital stay or incidence of postoperative surgical complications were observed.
","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Uhlig', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, University Hospital Carl Gustav Carus at the Technische Universität Dresden, Fetscherstr. 74, 01307, Dresden, Germany. christopher.uhlig@ukdd.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rössel', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, University Hospital Carl Gustav Carus at the Technische Universität Dresden, Fetscherstr. 74, 01307, Dresden, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Denz', 'Affiliation': 'Department of Gastrointestinal, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus at the Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Seifert', 'Affiliation': 'Department of Gastrointestinal, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus at the Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Thea', 'Initials': 'T', 'LastName': 'Koch', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, University Hospital Carl Gustav Carus at the Technische Universität Dresden, Fetscherstr. 74, 01307, Dresden, Germany.'}, {'ForeName': 'Axel Rüdiger', 'Initials': 'AR', 'LastName': 'Heller', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, University Hospital Carl Gustav Carus at the Technische Universität Dresden, Fetscherstr. 74, 01307, Dresden, Germany.'}]",BMC anesthesiology,['10.1186/s12871-019-0823-6']
938,31421677,Effect of neck extension on the advancement of tracheal tubes from the nasal cavity to the oropharynx in nasotracheal intubation: a randomized controlled trial.,"BACKGROUND


Clinicians sometimes encounter resistance in advancing a tracheal tube, which is inserted via a nostril, from the nasal cavity into the oropharynx during nasotracheal intubation. The purpose of this study was to investigate the effect of neck extension on the advancement of tracheal tubes from the nasal cavity into the oropharynx during nasotracheal intubation.
METHODS


Patients were randomized to the 'neck extension group (E group)' or 'neutral position group (N group)' for this randomized controlled trial. After induction of anesthesia, a nasal RAE tube was inserted via a nostril. For the E group, an anesthesiologist advanced the tube from the nasal cavity into the oropharynx with the patient's neck extended. For the N group, an anesthesiologist advanced the tube without neck extension. If the tube was successfully advanced into the oropharynx within two attempts by the same maneuver according to the assigned group, the case was defined as 'success.' We compared the success rate of tube advancement between the two groups.
RESULTS


Thirty-two patients in the E group and 33 in the N group completed the trial. The success rate of tube passage during the first two attempts was significantly higher in the E group than in the N group (93.8% vs. 60.6%; odds ratio = 9.75, 95% CI = [1.98, 47.94], p = 0.002).
CONCLUSION


Neck extension during tube advancement from the nasal cavity to the oropharynx before laryngoscopy could be helpful in nasotracheal intubation.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier NCT03377114 , registered on 13 December 2017.",2019,"The success rate of tube passage during the first two attempts was significantly higher in the E group than in the N group (93.8% vs. 60.6%; odds ratio = 9.75, 95% CI = [1.98, 47.94], p = 0.002).
","['Patients', 'registered on 13 December 2017', 'nasotracheal intubation']","[""neck extension group (E group)' or 'neutral position group"", 'neck extension']","['success rate of tube advancement', 'success rate of tube passage']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation (procedure)'}]","[{'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}]","[{'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0441478', 'cui_str': 'Surgical advancement - action'}]",32.0,0.0830075,"The success rate of tube passage during the first two attempts was significantly higher in the E group than in the N group (93.8% vs. 60.6%; odds ratio = 9.75, 95% CI = [1.98, 47.94], p = 0.002).
","[{'ForeName': 'Hyerim', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, 20 Boramae-ro 5-gil, Dongjak-gu, Seoul, 07061, Republic of Korea.'}, {'ForeName': 'Jung-Man', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, 20 Boramae-ro 5-gil, Dongjak-gu, Seoul, 07061, Republic of Korea. jungman007@gmail.com.'}, {'ForeName': 'Jiwon', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Keimyung University Dongsan Medical Center, Keimyung University School of Medicine, 1095 Dalgubeol-daero, Dalseo-gu, Daegu, 42601, Republic of Korea.'}, {'ForeName': 'Jin-Young', 'Initials': 'JY', 'LastName': 'Hwang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, 20 Boramae-ro 5-gil, Dongjak-gu, Seoul, 07061, Republic of Korea.'}, {'ForeName': 'Jee-Eun', 'Initials': 'JE', 'LastName': 'Chang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, 20 Boramae-ro 5-gil, Dongjak-gu, Seoul, 07061, Republic of Korea.'}, {'ForeName': 'Hyun-Joung', 'Initials': 'HJ', 'LastName': 'No', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Republic of Korea.'}, {'ForeName': 'Dongwook', 'Initials': 'D', 'LastName': 'Won', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, 20 Boramae-ro 5-gil, Dongjak-gu, Seoul, 07061, Republic of Korea.'}, {'ForeName': 'Hyung Sang', 'Initials': 'HS', 'LastName': 'Row', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, 03080, Republic of Korea.'}, {'ForeName': 'Seong-Won', 'Initials': 'SW', 'LastName': 'Min', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, 20 Boramae-ro 5-gil, Dongjak-gu, Seoul, 07061, Republic of Korea.'}]",BMC anesthesiology,['10.1186/s12871-019-0831-6']
939,31421679,"Palonosetron versus ondansetron for prevention of nausea and vomiting after total abdominal hysterectomy under spinal anesthesia with intrathecal morphine: a double-blind, randomized controlled trial.","BACKGROUND


Hysterectomy is a widely performed surgery and neuraxial anesthesia with intrathecal morphine provides superior quality of recovery. Postoperative nausea and vomiting (PONV) is a frequent problem with intrathecal morphine use. Although palonosetron is effective for prevention of PONV after general anesthesia, its efficacy after neuraxial anesthesia has not been established. This study was conducted to compare the use of palonosetron with ondansetron for PONV prophylaxis in patients at a high risk of PONV during total abdominal hysterectomy (TAH) under spinal anesthesia with intrathecal morphine.
METHODS


This prospective, randomized double-blind study conducted at São Rafael Hospital involved 140 American Society of Anesthesiologists physical status I or II women who underwent TAH under spinal anesthesia with intrathecal morphine and who had at least 3 risk factors for PONV based on Apfel's simplified score. The patients were randomized into two groups: one received palonosetron whereas the other received ondansetron. All patients received spinal anesthesia with intrathecal morphine, as well as dexamethasone plus palonosetron or ondansetron for PONV prophylaxis. The overall incidence of PONV, incidence of early- and late-onset nausea and vomiting, severity of nausea, and use of rescue antiemetics were recorded.
RESULTS


The overall incidence of PONV was 42.9% in the palonosetron group and 52.9% in the ondansetron group (p > 0.05). No significant differences existed in the incidence of early- and late-onset nausea or early-onset vomiting between the two groups. The incidence of late-onset vomiting was significantly lower in the palonosetron group.
CONCLUSIONS


Palonosetron exhibited efficacy similar to that of ondansetron for reducing the overall incidence of PONV after TAH under spinal anesthesia with intrathecal morphine; however, palonosetron reduced the incidence of late-onset vomiting significantly better than ondansetron.
TRIAL REGISTRATION


RBR-4gnm8n ( ensaiosclinicos.gov.br ), date of registration: August 18, 2014.",2019,No significant differences existed in the incidence of early- and late-onset nausea or early-onset vomiting between the two groups.,"['patients at a high risk of PONV during total abdominal hysterectomy (TAH) under spinal anesthesia with intrathecal morphine', ""140 American Society of Anesthesiologists physical status I or II women who underwent TAH under spinal anesthesia with intrathecal morphine and who had at least 3 risk factors for PONV based on Apfel's simplified score"", 'after total abdominal hysterectomy under spinal anesthesia with']","['palonosetron with ondansetron', 'dexamethasone plus palonosetron or ondansetron', 'Palonosetron versus ondansetron', 'spinal anesthesia with intrathecal morphine', 'intrathecal morphine', 'ondansetron', 'palonosetron']","['Postoperative nausea and vomiting (PONV', 'nausea and vomiting', 'overall incidence of PONV, incidence of early- and late-onset nausea and vomiting, severity of nausea, and use of rescue antiemetics', 'incidence of late-onset vomiting', 'incidence of early- and late-onset nausea or early-onset vomiting', 'overall incidence of PONV']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0404079', 'cui_str': 'Total abdominal hysterectomy (procedure)'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}]",140.0,0.382688,No significant differences existed in the incidence of early- and late-onset nausea or early-onset vomiting between the two groups.,"[{'ForeName': 'Guilherme Oliveira', 'Initials': 'GO', 'LastName': 'Campos', 'Affiliation': ""Department of Anesthesiology, São Rafael Hospital, D'Or Institute for Research and Education (IDOR), Salvador, Brazil. guioliveiracampos@gmail.com.""}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'de Jesus Martins', 'Affiliation': 'Department of Anesthesiology, São Paulo State University, Botucatu, Brazil.'}, {'ForeName': 'Gabriel Nascimento', 'Initials': 'GN', 'LastName': 'Jesus', 'Affiliation': ""Department of Anesthesiology, São Rafael Hospital, D'Or Institute for Research and Education (IDOR), Salvador, Brazil.""}, {'ForeName': 'Paulo Roberto Rios', 'Initials': 'PRR', 'LastName': 'de Oliveira', 'Affiliation': ""Department of Gynecology, São Rafael Hospital, D'Or Institute for Research and Education (IDOR), Salvador, Brazil.""}, {'ForeName': 'Caio Nogueira', 'Initials': 'CN', 'LastName': 'Lessa', 'Affiliation': ""Department of Gynecology, São Rafael Hospital, D'Or Institute for Research and Education (IDOR), Salvador, Brazil.""}, {'ForeName': 'João Carlos Macêdo Fernandes', 'Initials': 'JCMF', 'LastName': 'de Oliveira Junior', 'Affiliation': ""Department of Anesthesiology, São Rafael Hospital, D'Or Institute for Research and Education (IDOR), Salvador, Brazil.""}, {'ForeName': 'Lucas Jorge Santana', 'Initials': 'LJS', 'LastName': 'de Castro Alves', 'Affiliation': 'Department of Anesthesiology, Santo Antonio Hospital, Salvador, Brazil.'}, {'ForeName': 'Rodrigo Leal', 'Initials': 'RL', 'LastName': 'Alves', 'Affiliation': ""Department of Anesthesiology, São Rafael Hospital, D'Or Institute for Research and Education (IDOR), Salvador, Brazil.""}, {'ForeName': 'Norma Sueli Pinheiro', 'Initials': 'NSP', 'LastName': 'Módolo', 'Affiliation': 'Department of Anesthesiology, São Paulo State University, Botucatu, Brazil.'}]",BMC anesthesiology,['10.1186/s12871-019-0830-7']
940,31421685,"Comparison of the effect of sevoflurane or propofol anesthesia on the regional cerebral oxygen saturation in patients undergoing carotid endarterectomy: a prospective, randomized controlled study.","BACKGROUND


The monitoring of regional cerebral oxygen saturation (SrO 2 ) using near-infrared spectroscopy is useful method to detect cerebral ischemia during. Sevoflurane and propofol decrease cerebral metabolic rate (CMRO 2 ) in a similar manner, but the effects on the cerebral blood flow (CBF) are different. We hypothesized that the effects of sevoflurane and propofol on SrO 2  were different in patients with deficits of CBF. This study compared the effect of sevoflurane and propofol on SrO 2  of patients undergoing cerebral endarterectomy (CEA).
METHOD


Patients undergoing CEA were randomly assigned to the sevoflurane or propofol group (n = 74). The experiment was preceded in 2 stages based on carotid artery clamping. The first stage was from induction of anaesthesia to immediately before clamping of the carotid artery, and the second stage was until the end of the operation after clamping of the carotid artery. Oxygen saturation (SrO 2 , SpO 2 ), haemodynamic variables (blood pressure, heart rate), respiratory parameters (end-tidal carbon dioxide tension, inspired oxygen tension), concentration of anesthetics, and anesthesia depth (bispectral index score) were recorded.
RESULTS


During stage 1 period (before carotid artery clamping), the mean value of the relative changes in SrO 2  was higher (P = 0.033) and the maximal decrease in SrO 2  was lower in the sevoflurane group compared with the propofol group (P = 0.019) in the contralateral (normal) site. However, there is no difference in ipsilateral site (affected site). SrO 2  decreased after carotid artery clamping and increased after declamping, but the difference was not significant between two groups. Changes in mean arterial blood pressure was lower in sevoflurane group than propofol group after the carotid artery declamping (P = 0.048).
CONCLUSION


Propofol-remifentanil anesthesia was comparable with sevoflurane-remifentanil anesthesia in an aspect of preserving the SrO 2  in patients undergoing carotid endarterectomy.
TRIAL REGISTRATION


Clinical Trials.gov identifier: NCT02609087 , retrospectively registered on November 18, 2015.",2019,"Changes in mean arterial blood pressure was lower in sevoflurane group than propofol group after the carotid artery declamping (P = 0.048).
","['patients undergoing cerebral endarterectomy (CEA', 'Patients undergoing CEA', 'patients with deficits of CBF', 'patients undergoing carotid endarterectomy']","['sevoflurane and propofol', 'sevoflurane-remifentanil anesthesia', 'sevoflurane or propofol', 'propofol anesthesia', 'propofol', 'Propofol-remifentanil anesthesia', 'sevoflurane', 'Sevoflurane and propofol']","['Oxygen saturation (SrO 2 , SpO 2 ), haemodynamic variables (blood pressure, heart rate), respiratory parameters (end-tidal carbon dioxide tension, inspired oxygen tension), concentration of anesthetics, and anesthesia depth (bispectral index score', 'cerebral metabolic rate', 'cerebral blood flow (CBF', 'regional cerebral oxygen saturation', 'maximal decrease in SrO 2', 'mean arterial blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0014098', 'cui_str': 'Endarterectomy'}, {'cui': 'C0014099', 'cui_str': 'Carotid Endarterectomy'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0428664', 'cui_str': 'End tidal carbon dioxide tension (observable entity)'}, {'cui': 'C2711719', 'cui_str': 'PiO2'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C4273907', 'cui_str': 'Cerebral oxygen saturation (observable entity)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}]",,0.152602,"Changes in mean arterial blood pressure was lower in sevoflurane group than propofol group after the carotid artery declamping (P = 0.048).
","[{'ForeName': 'Sanghee', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chonnam National University Medical School and Hospital, 42 Jebong-ro, Dong-gu, Gwangju, 61469, South Korea.'}, {'ForeName': 'Keunbae', 'Initials': 'K', 'LastName': 'Yook', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chonnam National University Medical School and Hospital, 42 Jebong-ro, Dong-gu, Gwangju, 61469, South Korea.'}, {'ForeName': 'Kyung Yeon', 'Initials': 'KY', 'LastName': 'Yoo', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chonnam National University Medical School and Hospital, 42 Jebong-ro, Dong-gu, Gwangju, 61469, South Korea.'}, {'ForeName': 'Jeong Il', 'Initials': 'JI', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chonnam National University Medical School and Hospital, 42 Jebong-ro, Dong-gu, Gwangju, 61469, South Korea.'}, {'ForeName': 'Hong-Beom', 'Initials': 'HB', 'LastName': 'Bae', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chonnam National University Medical School and Hospital, 42 Jebong-ro, Dong-gu, Gwangju, 61469, South Korea.'}, {'ForeName': 'Youngwook', 'Initials': 'Y', 'LastName': 'You', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chonnam National University Medical School and Hospital, 42 Jebong-ro, Dong-gu, Gwangju, 61469, South Korea.'}, {'ForeName': 'Baoyuan', 'Initials': 'B', 'LastName': 'Jin', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chonnam National University Medical School and Hospital, 42 Jebong-ro, Dong-gu, Gwangju, 61469, South Korea.'}, {'ForeName': 'Seongtae', 'Initials': 'S', 'LastName': 'Jeong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chonnam National University Medical School and Hospital, 42 Jebong-ro, Dong-gu, Gwangju, 61469, South Korea. anesjst@jnu.ac.kr.'}]",BMC anesthesiology,['10.1186/s12871-019-0820-9']
941,30771559,A randomized trial of a multi-level intervention to increase water access and appeal in community recreation centers.,"INTRODUCTION


Improving children's tap water intake and reducing sugar-sweetened beverage (SSB) consumption is beneficial for health and health equity, particularly in low-income communities and communities of color. Existing community level interventions to improve the intake of tap water have predominantly occurred in schools and have focused on promoting water consumption in cafeterias during lunch or snack periods.
METHODS


The ""Hydrate Philly"" intervention was developed to target multiple environmental and social factors to improve tap water consumption in community recreation centers in low-income communities: replacing old and unappealing water fountains with appealing water-bottle-filling ""hydration stations"", conducting water safety testing and publicizing results, disseminating reusable water bottles, promoting tap water, and discouraging SSB consumption. Efficacy of the intervention will be tested through a group-randomized controlled trial (n = 28 centers) of the intervention's impact on center-level water fountain/station use as measured by flow meters during a youth summer camp program primarily for children aged 6-12 years. Intervention impact on the primary outcome (use of drinking water sources) will be examined with a difference-in-differences approach using an ordinary least squares regression model for analysis at the center level. Secondary outcomes include SSBs brought to summer camp, reusable and single-use bottled water use, program trash, and recreation center staff SSB consumption.
DISCUSSION


Multilevel approaches are needed to increase tap water intake and decrease SSB consumption among low-income and minority youth beyond school and meal settings. The current study describes the Hydrate Philly intervention, the study design, and baseline characteristics of recreation centers participating in the study. ClinicalTrials.gov Registration: #NCT03637465.",2019,Efficacy of the intervention will be tested through a group-randomized controlled trial (n = 28 centers) of the intervention's impact on center-level water fountain/station use as measured by flow meters during a youth summer camp program primarily for children aged 6-12 years.,"['community recreation centers in low-income communities', 'for children aged 6-12\u202fyears', 'recreation centers participating in the study', 'community recreation centers']","['sugar-sweetened beverage (SSB) consumption', 'multi-level intervention', 'center-level water fountain/station use as measured by flow meters during a youth summer camp program primarily']","['Efficacy', 'SSBs brought to summer camp, reusable and single-use bottled water use, program trash, and recreation center staff SSB consumption', 'SSB consumption']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0034872', 'cui_str': 'Recreation'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0012054', 'cui_str': ""N',O'-Dibutyryl-cAMP""}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0012054', 'cui_str': ""N',O'-Dibutyryl-cAMP""}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C4319838', 'cui_str': 'Bottle'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0017095', 'cui_str': 'Garbages'}, {'cui': 'C0034872', 'cui_str': 'Recreation'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.0853264,Efficacy of the intervention will be tested through a group-randomized controlled trial (n = 28 centers) of the intervention's impact on center-level water fountain/station use as measured by flow meters during a youth summer camp program primarily for children aged 6-12 years.,"[{'ForeName': 'Hannah G', 'Initials': 'HG', 'LastName': 'Lawman', 'Affiliation': 'Philadelphia Department of Public Health, Philadelphia, PA, USA. Electronic address: Hannah.Lawman@phila.gov.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Lofton', 'Affiliation': 'Philadelphia Department of Public Health, Philadelphia, PA, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Grossman', 'Affiliation': 'Philadelphia Department of Public Health, Philadelphia, PA, USA.'}, {'ForeName': 'Mica', 'Initials': 'M', 'LastName': 'Root', 'Affiliation': 'Philadelphia Department of Public Health, Philadelphia, PA, USA.'}, {'ForeName': 'Meka', 'Initials': 'M', 'LastName': 'Perez', 'Affiliation': 'Philadelphia Department of Public Health, Philadelphia, PA, USA; Philadelphia Parks and Recreation Department, Philadelphia, PA, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Tasian', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Anisha', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'School of Medicine, Stanford University, Stanford, CA, USA; Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco, CA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.02.003']
942,32052516,"Efficacy and safety of dual add-on therapy with dapagliflozin plus saxagliptin versus glimepiride in patients with poorly controlled type 2 diabetes on a stable dose of metformin: Results from a 52-week, randomized, active-controlled trial.","AIMS


To evaluate the efficacy and safety of dapagliflozin (DAPA) + saxagliptin (SAXA) compared with glimepiride (GLIM) in patients with type 2 diabetes who were inadequately controlled [glycated haemoglobin (HbA1c) 7.5-10.5% (58-91 mmol/mol)] on metformin monotherapy.
MATERIALS AND METHODS


This 52-week, multicentre, double-blind, active-controlled study (NCT02419612) randomized (1:1) patients on metformin to add-on DAPA 10 mg + SAXA 5 mg (n = 227) or GLIM 1-6 mg (titrated; n = 217). The primary efficacy endpoint was change in HbA1c from baseline to week 52.
RESULTS


Baseline mean ± standard deviation of age, duration of diabetes and HbA1c were 56.1 ± 9.7 years, 7.8 ± 6.4 years and 8.5% ± 0.8% (69 ± 9.0 mmol/mol), respectively. Adjusted mean change from baseline in HbA1c was -1.35% (-14.8 mmol/mol) with DAPA + SAXA versus -0.98% (-10.7 mmol/mol) with GLIM (P <0.001). Changes from baseline in body weight and systolic blood pressure were -3.1 kg and -2.6 mmHg with DAPA + SAXA versus +1.0 kg (P <0.001) and +1.0 mmHg (P = 0.007) with GLIM. More patients achieved HbA1c <7.0% (53 mmol/mol) (44.3% vs. 34.3%; P = 0.044), and fewer patients required treatment intensification (1.3% vs. 8.8%; P = 0.002) with DAPA + SAXA than with GLIM.
CONCLUSIONS


Compared with GLIM, concurrent addition of DAPA + SAXA significantly improved glycaemic control, body weight and other metabolic parameters in patients inadequately controlled on metformin. Trial: NCT02419612, ClinicalTrials.gov.",2020,Adjusted mean change from baseline in HbA 1c  was -1.35% (-14.8 mmol/mol) with DAPA + SAXA versus -0.98% (-10.7 mmol/mol) with GLIM (P < 0.001).,"['patients inadequately controlled on', 'patients with poorly controlled type 2 diabetes on a stable dose of', 'patients with type 2 diabetes inadequately controlled (glycated haemoglobin ', 'were 56.1 (9.7) years, 7.8 (6.4) years and 8.5% (0.8']","['metformin', 'glimepiride (GLIM', 'dapagliflozin (DAPA) plus saxagliptin (SAXA', 'dapagliflozin plus saxagliptin', 'metformin to add-on DAPA 10 mg plus SAXA', 'glimepiride', 'DAPA + SAXA']","['change in HbA 1c', 'efficacy and safety', 'body weight and systolic blood pressure', 'Baseline mean (standard deviation [SD]) age, duration of diabetes and HbA 1c', 'glycaemic control, body weight and other metabolic parameters', 'Efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517822', 'cui_str': '6.4 (qualifier value)'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C4517481', 'cui_str': '0.8'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1611934', 'cui_str': 'saxagliptin'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.188329,Adjusted mean change from baseline in HbA 1c  was -1.35% (-14.8 mmol/mol) with DAPA + SAXA versus -0.98% (-10.7 mmol/mol) with GLIM (P < 0.001).,"[{'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Frias', 'Affiliation': 'National Research Institute, Los Angeles, California.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Gonzalez-Galvez', 'Affiliation': 'Jalisco Institute of Diabetes and Obesity Research, Guadalajara, Mexico.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Johnsson', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Maaske', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Marcia A', 'Initials': 'MA', 'LastName': 'Testa', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Donald C', 'Initials': 'DC', 'LastName': 'Simonson', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Nalina', 'Initials': 'N', 'LastName': 'Dronamraju', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Garcia-Sanchez', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Peters', 'Affiliation': 'Keck School of Medicine of the University of Southern California, Los Angeles, California.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13997']
943,31999174,Mechanisms of physical activity behavior change in an incentive-based intervention: Mediation analysis.,"OBJECTIVE


The physical activity loyalty (PAL) scheme was a cluster randomized controlled trial of a 6-month complex intervention targeting workplace physical activity. Financial incentives were incorporated in an evidence-based behavior change program, including self-regulation techniques. This article examines short-term (< 6 months) and long-term (≥ 6 months) mediation effects on physical activity.
METHOD


Participants included 853 adults (457 intervention, 396 control). Physical activity was objectively assessed using pedometers at baseline and at 6 and 12 months. Hypothesized short-term mediators (e.g., self-efficacy, intentions) were assessed at baseline and 4 weeks. Hypothesized long-term mediators (e.g., habit, intrinsic motivation) were assessed at baseline and 6 months. Mediation models employed the structural equation modeling product-of-coefficients approach.
RESULTS


Intervention participants experienced significant decreases in 6-month pedometer steps/day versus controls ( b  = -336,  p  = .02), which were partially mitigated by positive indirect effects through 6-month integrated regulation ( ab  = 94.7, 95% CI [18.7, 204.4]), intrinsic motivation  (ab  = 59.0, 95% CI [3.09, 154.5]), and habit ( ab  = 198.7, 95% CI [84.3, 369.9]). There were no between-groups differences in 12-month pedometer steps/day but positive indirect effects through 6-month integrated regulation ( ab  = 128.0, 95% CI [27.3, 313.2]), planning ( ab  = 115.0, 95% CI [3.71, 285.5]), and habit ( ab  = 153.3, 95% CI [39.3, 333.1]).
CONCLUSIONS


Most examined mediators were nonsignificant, and mediation analyses did not explain decreases in physical activity for interventions versus controls. Results show that, contrary to self-determination theory hypotheses, intrinsic motivation is not necessarily adversely impacted if financial incentives are embedded in a complex intervention. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,"RESULTS


Intervention participants experienced significant decreases in 6-month pedometer steps/day versus controls ( b  = -336,  p  = .02), which were partially mitigated by positive indirect effects through 6-month integrated regulation ( ab  = 94.7, 95% CI [18.7, 204.4]), intrinsic motivation  (ab  = 59.0, 95% CI [3.09, 154.5]), and habit ( ab  = 198.7, 95% CI [84.3, 369.9]).","['Participants included 853 adults (457 intervention, 396 control']",[],"['Physical activity', 'intrinsic motivation', 'physical activity', '6-month pedometer steps']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0392350', 'cui_str': 'Intrinsic motivation, function (observable entity)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}]",853.0,0.100544,"RESULTS


Intervention participants experienced significant decreases in 6-month pedometer steps/day versus controls ( b  = -336,  p  = .02), which were partially mitigated by positive indirect effects through 6-month integrated regulation ( ab  = 94.7, 95% CI [18.7, 204.4]), intrinsic motivation  (ab  = 59.0, 95% CI [3.09, 154.5]), and habit ( ab  = 198.7, 95% CI [84.3, 369.9]).","[{'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Murray', 'Affiliation': 'Centre for Public Health.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'French', 'Affiliation': 'Manchester Centre of Health Psychology.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kee', 'Affiliation': 'Centre for Public Health.'}, {'ForeName': 'Aisling', 'Initials': 'A', 'LastName': 'Gough', 'Affiliation': 'School of Nursing and Midwifery.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'School of Agricultural Economics and Rural Development.'}, {'ForeName': 'Ruth F', 'Initials': 'RF', 'LastName': 'Hunter', 'Affiliation': 'Centre for Public Health.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000849']
944,31167872,Randomised controlled trial of a novel online cognitive rehabilitation programme for children with cerebral palsy: a study protocol.,"INTRODUCTION


Cerebral palsy (CP) is the most common cause of physical disability in children, with an estimated 600-700 infants born with CP in Australia each year. CP is typically associated with motor impairments, but nearly half of all children with CP also experience cognitive impairment, potentially impacting educational and vocational achievement. This paper reports the protocol for a randomised controlled trial of a computerised cognitive training intervention based on behavioural principles: Strengthening Mental Abilities through Relational Training (SMART). The study aims to investigate SMART's effect on fluid reasoning, executive function and academic achievement in children with CP.
METHODS AND ANALYSIS


Sixty children with mild to moderate CP (Gross Motor Function Classification Scale I-IV) aged between 8 years and 12 years will be recruited. Participants will be randomly allocated to two groups: SMART cognitive training and waitlist control. Families will access the programme at home over a 4-month period. Assessments will be administered at baseline, 20 weeks and at 40 week follow-up for retention. The primary outcome will be fluid intelligence, while academic achievement, executive function and social and emotional well-being will be secondary outcomes.
ETHICS AND DISSEMINATION


This study has approval from the Children's Health Queensland Hospital and Health Service Research Ethics Committee (HREC/14/QRCH/377) and The University of Queensland (2017001806). If the computerised cognitive training programme is found to be effective, dissemination of these findings would assist children with CP by providing an accessible, cost-effective intervention that can be completed at home at the individual's own pace.
REGISTRATION DETAILS


The study was registered prospectively on 10 November 2017 to present. Recruitment is now under way, and we aim to complete recruitment by June 2019, with data collection finalised by March 2020.
TRIAL REGISTRATION NUMBER


ACTRN12617001550392; Pre-results.",2019,"If the computerised cognitive training programme is found to be effective, dissemination of these findings would assist children with CP by providing an accessible, cost-effective intervention that can be completed at home at the individual's own pace.
","['children, with an estimated 600-700 infants born with CP in Australia each year', 'children with cerebral palsy', '10 November 2017 to present', 'Sixty children with mild to moderate CP (Gross Motor Function Classification Scale I-IV) aged between 8 years and 12 years will be recruited', 'children with CP']","['computerised cognitive training intervention', 'computerised cognitive training programme', 'SMART cognitive training and waitlist control', 'novel online cognitive rehabilitation programme', 'Relational Training (SMART']","['fluid reasoning, executive function and academic achievement', 'fluid intelligence, while academic achievement, executive function and social and emotional well-being will be secondary outcomes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions (observable entity)'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0222045'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0013658', 'cui_str': 'Educational Achievement'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",60.0,0.111881,"If the computerised cognitive training programme is found to be effective, dissemination of these findings would assist children with CP by providing an accessible, cost-effective intervention that can be completed at home at the individual's own pace.
","[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Wotherspoon', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Koa', 'Initials': 'K', 'LastName': 'Whittingham', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Roslyn N', 'Initials': 'RN', 'LastName': 'Boyd', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Jeanie', 'Initials': 'J', 'LastName': 'Sheffield', 'Affiliation': 'School of Psychology, The University of Queensland, Brisbane, Queensland, Australia.'}]",BMJ open,['10.1136/bmjopen-2018-028505']
945,31203242,Molidustat for the treatment of renal anaemia in patients with non-dialysis-dependent chronic kidney disease: design and rationale of two phase III studies.,"INTRODUCTION


Anaemia is a common complication of chronic kidney disease (CKD). Owing to the limitations of erythropoiesis-stimulating agents (ESAs), the current standard of care, there is a need to develop new therapies. Hypoxia-inducible factor prolyl-hydroxylase (HIF-PH) inhibitors might be a promising new treatment option. Molidustat is an oral HIF-PH inhibitor that stimulates the endogenous, predominantly renal, production of erythropoietin and was generally well tolerated in phase IIb clinical trials. Here, we report the design and rationale of two studies from the molidustat phase III programme: MolIdustat once dailY improves renal Anaemia By Inducing erythropoietin (MIYABI).
METHODS AND ANALYSIS


MIYABI Non-Dialysis-Correction (ND-C) and MIYABI Non-Dialysis-Maintenance (ND-M) are randomised, open-label, parallel-group, multicentre studies that aim to demonstrate the efficacy of molidustat treatment compared with darbepoetin alfa in patients with anaemia and non-dialysis-dependent CKD. The secondary objectives are to assess the safety, pharmacokinetics and pharmacodynamics of molidustat treatment. MIYABI ND-C will recruit patients currently untreated with ESAs, whereas patients treated with an ESA will enter MIYABI ND-M. Each study will recruit 150 patients who will be randomised in a 1:1 ratio to receive either molidustat or darbepoetin alfa for 52 weeks, with efficacy evaluated during weeks 30-36. Study drug doses will be titrated regularly using an interactive voice/web response system with the aim of maintaining the patients' haemoglobin (Hb) levels between ≥110 and <130 g/L. The primary objective will be achieved if, in molidustat-treated patients, the mean Hb level remains within the target range during the evaluation period, and if the change in the mean Hb level at evaluation time points from baseline is non-inferior to darbepoetin alfa.
ETHICS AND DISSEMINATION


The protocols were approved by ethics committees at all participating sites. These studies will be conducted in accordance with the Declaration of Helsinki and the Good Clinical Practice guidelines. Results arising from these studies will be published in peer-reviewed journal(s).
TRIAL REGISTRATION NUMBERS


NCT03350321; Pre-results, NCT03350347; Pre-results.",2019,"The primary objective will be achieved if, in molidustat-treated patients, the mean Hb level remains within the target range during the evaluation period, and if the change in the mean Hb level at evaluation time points from baseline is non-inferior to darbepoetin alfa.
","['patients with anaemia and non-dialysis-dependent CKD', 'patients with non-dialysis-dependent chronic kidney disease', '150 patients who will be randomised in a 1:1 ratio to receive either', 'MIYABI Non-Dialysis-Correction (ND-C) and MIYABI Non-Dialysis-Maintenance (ND-M', ""patients' haemoglobin (Hb) levels between ≥110 and <130\u2009g/L""]","['Hypoxia-inducible factor prolyl-hydroxylase (HIF-PH) inhibitors', 'molidustat or darbepoetin alfa', 'darbepoetin alfa', 'erythropoiesis-stimulating agents (ESAs']","['renal anaemia', 'renal Anaemia By Inducing erythropoietin (MIYABI', 'safety, pharmacokinetics and pharmacodynamics']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C3665675', 'cui_str': 'Prolyl 4-Hydroxylase'}, {'cui': 'C4078705', 'cui_str': 'molidustat'}, {'cui': 'C0937950', 'cui_str': 'darbepoetin alfa'}, {'cui': 'C1959590', 'cui_str': 'Erythropoiesis Stimulating Agents'}]","[{'cui': 'C1142276', 'cui_str': 'Renal anemia'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}]",150.0,0.0556361,"The primary objective will be achieved if, in molidustat-treated patients, the mean Hb level remains within the target range during the evaluation period, and if the change in the mean Hb level at evaluation time points from baseline is non-inferior to darbepoetin alfa.
","[{'ForeName': 'Hiroyasu', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Taguchi', 'Affiliation': 'MAF Pulmonology & Cardiology, Medical Affairs, Bayer Yakuhin, Ltd, Osaka, Japan.'}, {'ForeName': 'Yoshimi', 'Initials': 'Y', 'LastName': 'Matsuda', 'Affiliation': 'Statistics & Data Insights, Data Sciences & Analytics, Research & Development, Bayer Yakuhin, Ltd, Osaka, Japan.'}, {'ForeName': 'Kazuma', 'Initials': 'K', 'LastName': 'Iekushi', 'Affiliation': 'MAF Pulmonology & Cardiology, Medical Affairs, Bayer Yakuhin, Ltd, Osaka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'TA Thrombosis & Nephrology, Clinical Development & Operations, Research & Development, Bayer Yakuhin, Ltd, Osaka, Japan.'}, {'ForeName': 'Tadao', 'Initials': 'T', 'LastName': 'Akizawa', 'Affiliation': 'Division of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.'}]",BMJ open,['10.1136/bmjopen-2018-026704']
946,32151460,"Erratum to 'Erythrocyte-encapsulated asparaginase (eryaspase) combined with chemotherapy in second-line treatment of advanced pancreatic cancer: An open-label, randomized Phase IIb trial' [European Journal of Cancer, Volume 124 (January 2020) Pages 91-101].",,2020,,['advanced pancreatic cancer'],['Erythrocyte-encapsulated asparaginase (eryaspase) combined with chemotherapy'],[],"[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}]","[{'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0205223', 'cui_str': 'Encapsulated (qualifier value)'}, {'cui': 'C0003993', 'cui_str': 'ASPARAGINASE'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]",[],,0.0238767,,"[{'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Hammel', 'Affiliation': 'Digestive and Medical Oncology Unit, Hôpital Beaujon, Assistance Publique - Hôpitaux de Paris, University Denis Diderot Paris VII, 92110 Clichy, France. Electronic address: pascal.hammel@aphp.fr.'}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Portales', 'Affiliation': 'Parc Euromedecine, 208 Rue Des Apothicaires, 34070 Montpellier, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Mineur', 'Affiliation': 'Institut Sainte Catherine, Gastrointestinal and Liver Cancer Unit, Chemin de Baigne Pieds, 84000 Avignon, France.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Metges', 'Affiliation': 'CHRU de Brest - Hôpital Morvan, 2 Avenue Foch, 29609 Brest, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Andre', 'Affiliation': 'Hôpital Saint-Antoine, 184 Rue du Faubourg Saint-Antoine, 75012 Paris, and Sorbonne Universités, France.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'De La Fouchardiere', 'Affiliation': 'Medical Oncology Department, Centre Leon Berard, Lyon, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Louvet', 'Affiliation': 'Department of Medical Oncology, Institut Mutualiste Montsouris, 42 Boulevard Jourdan, 75014 Paris, France.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'El Hajbi', 'Affiliation': 'Centre Oscar Lambret, 3 Rue Frédéric Combemale, 59000 Lille, France.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Faroux', 'Affiliation': 'Les Oudairies, Hospital La Roche-Sur-Yon, Boulevard Stephane Moreau, 85000 La Roche Sur Yon, France.'}, {'ForeName': 'Rosine', 'Initials': 'R', 'LastName': 'Guimbaud', 'Affiliation': 'Institut Universitaire du Cancer, Avenue Hubert Curien, 31100 Toulouse, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tougeron', 'Affiliation': 'Gastroenterology Department and Medical Oncology Department, Poitiers University Hospital, Faculty of Medicine of Poitiers, 86000 Poitiers, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bouche', 'Affiliation': 'Service Oncologie Digestive, CHU Reims, Avenue Général Koenig, 51092 Reims Cede, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lecomte', 'Affiliation': 'Department of Hepatogastroenterology and Digestive Oncology, CHU de Tours, 37044 Tours Cedex, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Rebischung', 'Affiliation': 'Groupe Hospitalier Mutualiste de Grenoble, 8 Rue Docteur Calmette, 38100 Grenoble, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Tournigand', 'Affiliation': ""Service d'Oncologie médicale, Hôpital Henri Mondor, AP-HP, Université Paris-Est, 94010 Créteil, France.""}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Cros', 'Affiliation': 'Beaujon University Hospital, Department of Pathology-INSERM U1149, 100 Bvd Gal Lerclerc, 92110 Clichy, France.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kay', 'Affiliation': 'RK Statistics Ltd, St Giles View, Main Street, Great Longstone, Bakewell DE45 1TZ, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Hamm', 'Affiliation': 'Cytel Inc., 675 Massachusetts Ave, Cambridge, MA 02139, USA.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'ERYTECH, One Main Street, Suite 1150, Cambridge, MA 02142, USA.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Bachet', 'Affiliation': 'Sorbonne Universités, UPMC Université, Gastroenterology and Digestive Oncology Department, Pitié Salpêtrière Hospital, 75013 Paris, France; Service Oncologie Digestive, CHU Reims, Avenue Général Koenig, 51092 Reims Cede, France.'}, {'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'El Hariry', 'Affiliation': 'ERYTECH, One Main Street, Suite 1150, Cambridge, MA 02142, USA; Service Oncologie Digestive, CHU Reims, Avenue Général Koenig, 51092 Reims Cede, France.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.02.004']
947,32147465,Jigsaw Group-Based Learning in Difficult Airway Management: An Alternative Way to Teach Surgical Didactics.,"OBJECTIVE


We describe the effectiveness of the Jigsaw method in the instruction of residents in difficulty airway management.
DESIGN


The residents were given a pre-Jigsaw instruction test and a self-assessment of their skills for bag-mask ventilation, Intubation, cricothyrotomy, and tracheostomy. After the completing the pre-test, they were randomly assigned tasks from A-D, with each letter corresponding to a section of reading from Cumming's Otolaryngology and related questions. The residents were given ten minutes to read their portion of the article, and then another ten minutes to discuss their section with others assigned the same responsibilities, thereby becoming ""experts."" Then, the ""experts"" were assigned to a second group where they had ten minutes to teach their peers their designated material and learned from their peers the other designated material. A skill simulation lab was then performed involving intubation, cricothyrotomy, and tracheotomy. The residents were then given a post-Jigsaw instruction test and post simulation lab selfassessment of their skills for bag-mask ventilation, intubation, cricothyrotomy and tracheotomy.
SETTING


Renaissance School of Medicine at Stony Brook University.
PARTICIPANTS


General surgery, otolaryngology, plastic surgery, and oral and maxillofacial surgery residents.
RESULTS


Post-Jigsaw tests scores a statistically significant increase in the number of correctly answered questions (P< 0.001) and residents reported a statistically significant increase in confidence in performing difficult airway skills.
CONCLUSIONS


The Jigsaw method of learning is an effective alternative to tradition lecture-based methods.",2020,"RESULTS


Post-Jigsaw tests scores a statistically significant increase in the number of correctly answered questions (P< 0.001) and residents reported a statistically significant increase in confidence in performing difficult airway skills.
","['General surgery, otolaryngology, plastic surgery, and oral and maxillofacial surgery residents', 'in Difficult Airway Management', 'Renaissance School of Medicine at Stony Brook University', 'residents in difficulty airway management']","['pre-Jigsaw instruction test and a self-assessment of their skills for bag-mask ventilation, Intubation, cricothyrotomy, and tracheostomy', 'post-Jigsaw instruction test and post simulation lab selfassessment of their skills for bag-mask ventilation, intubation, cricothyrotomy and tracheotomy', 'Jigsaw Group-Based Learning']",['confidence in performing difficult airway skills'],"[{'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0029892', 'cui_str': 'Otorhinolaryngology'}, {'cui': 'C0038911', 'cui_str': 'Surgery, Plastic'}, {'cui': 'C0812928', 'cui_str': 'Oral and maxillofacial surgery'}, {'cui': 'C0332218', 'cui_str': 'With difficulty'}, {'cui': 'C0150126', 'cui_str': 'Airway Control'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment (Psychology)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0396429', 'cui_str': 'Cricothyroidotomy (procedure)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0040591', 'cui_str': 'Tracheotomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332218', 'cui_str': 'With difficulty'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}]",,0.0350697,"RESULTS


Post-Jigsaw tests scores a statistically significant increase in the number of correctly answered questions (P< 0.001) and residents reported a statistically significant increase in confidence in performing difficult airway skills.
","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Alrassi', 'Affiliation': 'Renaissance School of Medicine at Stony Brook University Stony Brook, New York. Electronic address: james.alrassi@stonybrookmedicine.edu.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Mortensen', 'Affiliation': 'Department of Surgery, Division of Otolaryngology-Head and Neck Surgery, Stony Brook Medicine, Stony Brook, New York.'}]",Journal of surgical education,['10.1016/j.jsurg.2020.02.003']
948,30871628,Follicular lymphoma patients with KIR2DL2 and KIR3DL1 and their ligands (HLA-C1 and HLA-Bw4) show improved outcome when receiving rituximab.,"BACKGROUND


The ECOG-ACRIN Cancer Research Group evaluated rituximab treatment schedules for patients with newly-diagnosed low-tumor-burden follicular-lymphoma (FL). All patients received 4-weekly rituximab treatments as induction therapy. Clinically-responding patients were randomized to receive rituximab every 13 weeks (""maintenance"") vs. no additional rituximab until progression (""non-maintenance""). Based on ""time-to-rituximab-failure (TTRF)"", the study-committee reported there was no overall-benefit for maintenance rituximab in this setting. Tumor-reactive mAbs, like rituximab, trigger natural killer (NK) cells. NK-cell responses are regulated, in part, by interactions between killer immunoglobulin-like receptors (KIRs) on NK cells and their interactions with KIR-ligands. In a separate study of children with neuroblastoma treated with a different mAb, we found certain KIR/KIR-ligand genotypes associated with improved outcome. Here, we assessed whether a subset of FL patients show improved outcome from the maintenance rituximab based on these same KIR/KIR-ligand genotypes.
METHODS


Genotypes for KIR/KIR-ligand were determined and assessed for associations with outcome [duration of response, TTRF and % tumor shrinkage] as a post-hoc analysis of this phase III trial. Our primary objective was to assess specific KIR/KIR-ligand genotype associations, followed by separate prespecified KIR/KIR-ligand genotype associations in follow-up analyses. Statistical analyses for association of genotype with clinical outcome included: Log-rank tests and Cox proportional hazards regression models to assess duration of response and TTRF; analysis of variance (ANOVA) was used for assessment of % tumor shrinkage.
RESULTS


We found that patients inheriting KIR2DL2 and its ligand (HLA-C1) along with KIR3DL1 and its ligand (HLA-Bw4) had improved outcome over patients without this genotype. In addition, patients with KIR2DL2 and HLA-C1 along with KIR3DL1 and HLA-Bw4 also showed improved duration of response and tumor shrinkage if they received maintenance, while patients without this genotype showed no such improvement when receiving maintenance.
CONCLUSIONS


The data presented here indicate that a subset of FL patients, identified by certain KIRs/KIR-ligands, have improved outcome and may benefit from additional rituximab treatment. Taken together, this suggests that the efficacy of tumor-reactive mAb treatment for some patients is influenced by KIRs on NK cells. However, prior to considering these genotypes in a clinically-actionable manner, these findings need independent validation in other studies.",2019,We found that patients inheriting KIR2DL2 and its ligand (HLA-C1) along with KIR3DL1 and its ligand (HLA-Bw4) had improved outcome over patients without this genotype.,['patients with newly-diagnosed low-tumor-burden follicular-lymphoma (FL'],"['rituximab every 13\u2009weeks (""maintenance"") vs. no additional rituximab until progression (""non-maintenance', 'rituximab', '4-weekly rituximab']",['duration of response and tumor shrinkage'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1449699', 'cui_str': 'Tumor Burden'}, {'cui': 'C0024301', 'cui_str': 'Brill-Symmers Disease'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage (finding)'}]",,0.0319316,We found that patients inheriting KIR2DL2 and its ligand (HLA-C1) along with KIR3DL1 and its ligand (HLA-Bw4) had improved outcome over patients without this genotype.,"[{'ForeName': 'Amy K', 'Initials': 'AK', 'LastName': 'Erbe', 'Affiliation': 'Department of Human Oncology, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Human Oncology, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Lakeesha', 'Initials': 'L', 'LastName': 'Carmichael', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hoefges', 'Affiliation': 'Department of Human Oncology, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Bartosz', 'Initials': 'B', 'LastName': 'Grzywacz', 'Affiliation': 'Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Patrick K', 'Initials': 'PK', 'LastName': 'Reville', 'Affiliation': 'Department of Human Oncology, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Ranheim', 'Affiliation': 'Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Jacquelyn A', 'Initials': 'JA', 'LastName': 'Hank', 'Affiliation': 'Department of Human Oncology, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'KyungMann', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Songwon', 'Initials': 'S', 'LastName': 'Seo', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Eneida A', 'Initials': 'EA', 'LastName': 'Mendonca', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Yiqiang', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Vaishalee P', 'Initials': 'VP', 'LastName': 'Kenkre', 'Affiliation': 'Department of Medicine, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Fangxin', 'Initials': 'F', 'LastName': 'Hong', 'Affiliation': 'Department of Biostatistics, Harvard University, Dana Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Randy D', 'Initials': 'RD', 'LastName': 'Gascoyne', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Centre for Lymphoid Cancer, British Columbia Cancer Agency, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Paietta', 'Affiliation': 'Montefiore Medical Center-North Division, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Sandra J', 'Initials': 'SJ', 'LastName': 'Horning', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Miller', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Kahl', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Sondel', 'Affiliation': 'Department of Human Oncology, University of Wisconsin, Madison, WI, USA. pmsondel@humonc.wisc.edu.'}]",Journal for immunotherapy of cancer,['10.1186/s40425-019-0538-8']
949,30840040,Effectiveness of Training Therapists to Deliver An Individualized Mental Health Intervention for Children With ASD in Publicly Funded Mental Health Services: A Cluster Randomized Clinical Trial.,"Importance


Publicly funded mental health services play an important role in addressing co-occurring mental health problems in children with autism spectrum disorder (ASD); however, therapists report lacking training to effectively serve this complex population.
Objective


To test the effectiveness of training community therapists in An Individualized Mental Health Intervention for ASD (AIM HI) on challenging behaviors across 18 months among children with ASD and identify moderators and mediators of any intervention effects.
Design, Setting, and Participants


Cluster randomized trial conducted in 29 publicly funded outpatient and school-based mental health programs in southern California from 2012 to 2017. Programs were randomized to receive immediate AIM HI training or provide usual care followed by receipt of AIM HI training. Therapist participants were recruited from enrolled programs, and child participants were recruited from participant therapists' caseloads. Data were analyzed from 202 children with ASD who were aged 5 to 13 years.
Interventions


The AIM HI protocol is a package of parent-mediated and child-focused strategies aimed to reduce challenging behaviors in children with ASD who are 5 to 13 years old. It was designed for delivery in publicly funded mental health services based on a systematic assessment of therapist training needs and child clinical needs. The therapist training and consultation process takes approximately 6 months and includes an introductory workshop, 11 structured consultation meetings as the therapist delivers AIM HI with a current client, and case-specific performance feedback from trainers.
Main Outcomes and Measures


Child participants were assessed for challenging behaviors using the Eyberg Child Behavior Inventory (ECBI) and Social Skills Improvement System (SSIS) Competing Problem Behaviors scales based on parent report at baseline and at 6-month intervals for 18 months. Outcomes were analyzed using intent-to-treat models.
Results


In total, 202 children with ASD (mean [SD] age, 9.1 [2.4] years; 170 [84.2%] male; 121 [59.9%] Latinx) were eligible, enrolled, and included in the analyses. Statistically significant group by time interactions for the ECBI Intensity (B = -0.38; P = .02) and ECBI Problem (B = -1.00; P = .005) scales were observed, with significantly larger decreases in ECBI Intensity scores in the AIM HI group (B = -1.36; P < .001) relative to the usual care group (B = -0.98; P < .001) and a significantly larger decrease in ECBI Problem scores in the AIM HI group (B = -1.22; P < .001) relative to the usual care group (B = -0.20; P = .29). Therapist fidelity moderated these intervention effects.
Conclusions and Relevance


The present findings support the effectiveness of training therapists to deliver the AIM HI model to children with ASD receiving publicly funded mental health services.
Trial Registration


ClinicalTrials.gov identifier: NCT02416323.",2019,"Statistically significant group by time interactions for the ECBI Intensity (B = -0.38; P = .02) and ECBI Problem (B = -1.00; P = .005) scales were observed, with significantly larger decreases in ECBI Intensity scores in the AIM HI group (B = -1.36; P < .001) relative to the usual care group (B = -0.98; P < .001) and a significantly larger decrease in ECBI Problem scores in the AIM HI group (B = -1.22; P < .001) relative to the usual care group (B = -0.20; P = .29).","['children with ASD', '202 children with ASD (mean [SD] age, 9.1 [2.4] years; 170 [84.2%] male; 121 [59.9%] Latinx) were eligible, enrolled, and included in the analyses', 'Children With ASD in Publicly Funded Mental Health Services', 'children with autism spectrum disorder (ASD', '29 publicly funded outpatient and school-based mental health programs in southern California from 2012 to 2017', '202 children with ASD who were aged 5 to 13 years', 'children with ASD who are 5 to 13 years old', 'children with ASD receiving publicly funded mental health services', ""Therapist participants were recruited from enrolled programs, and child participants were recruited from participant therapists' caseloads""]","['immediate AIM HI training or provide usual care followed by receipt of AIM HI training', 'training community therapists', 'Training Therapists to Deliver An Individualized Mental Health Intervention']","['ECBI Problem scores', 'ECBI Problem', 'challenging behaviors using the Eyberg Child Behavior Inventory (ECBI) and Social Skills Improvement System (SSIS', 'ECBI Intensity scores', 'ECBI Intensity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0025355', 'cui_str': 'Mental Hygiene Services'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0679005', 'cui_str': 'Interpersonal Skills'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",202.0,0.11482,"Statistically significant group by time interactions for the ECBI Intensity (B = -0.38; P = .02) and ECBI Problem (B = -1.00; P = .005) scales were observed, with significantly larger decreases in ECBI Intensity scores in the AIM HI group (B = -1.36; P < .001) relative to the usual care group (B = -0.98; P < .001) and a significantly larger decrease in ECBI Problem scores in the AIM HI group (B = -1.22; P < .001) relative to the usual care group (B = -0.20; P = .29).","[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Brookman-Frazee', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, La Jolla.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Roesch', 'Affiliation': 'Department of Psychology, San Diego State University, San Diego, California.'}, {'ForeName': 'Colby', 'Initials': 'C', 'LastName': 'Chlebowski', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, La Jolla.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Baker-Ericzen', 'Affiliation': 'Child and Adolescent Services Research Center, San Diego, California.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Ganger', 'Affiliation': 'Child and Adolescent Services Research Center, San Diego, California.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.0011']
950,30844471,"The rationale and design of the personal diet study, a randomized clinical trial evaluating a personalized approach to weight loss in individuals with pre-diabetes and early-stage type 2 diabetes.","Weight loss reduces the risk of type 2 diabetes mellitus (T2D) in overweight and obese individuals. Although the physiological response to food varies among individuals, standard dietary interventions use a ""one-size-fits-all"" approach. The Personal Diet Study aims to evaluate two dietary interventions targeting weight loss in people with prediabetes and T2D: (1) a low-fat diet, and (2) a personalized diet using a machine-learning algorithm that predicts glycemic response to meals. Changes in body weight, body composition, and resting energy expenditure will be compared over a 6-month intervention period and a subsequent 6-month observation period intended to assess maintenance effects. The behavioral intervention is delivered via mobile health technology using the Social Cognitive Theory. Here, we describe the design, interventions, and methods used.",2019,The Personal Diet Study aims to evaluate two dietary interventions targeting weight loss in people with prediabetes and T2D:,"['overweight and obese individuals', 'people with prediabetes and T2D', 'individuals with pre-diabetes and early-stage type 2 diabetes']",['Weight loss'],"['weight loss', 'body weight, body composition, and resting energy expenditure']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}]",,0.0408298,The Personal Diet Study aims to evaluate two dietary interventions targeting weight loss in people with prediabetes and T2D:,"[{'ForeName': 'Collin J', 'Initials': 'CJ', 'LastName': 'Popp', 'Affiliation': 'Department of Population Health, Center for Healthful Behavior Change, New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'St-Jules', 'Affiliation': 'Department of Population Health, Center for Healthful Behavior Change, New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': 'Department of Population Health, Center for Healthful Behavior Change, New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Ganguzza', 'Affiliation': 'Department of Population Health, Center for Healthful Behavior Change, New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Paige', 'Initials': 'P', 'LastName': 'Illiano', 'Affiliation': 'Department of Population Health, Center for Healthful Behavior Change, New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Curran', 'Affiliation': 'Department of Population Health, Center for Healthful Behavior Change, New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Huilin', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Population Health, Division of Biostatistics, New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Antoinette', 'Initials': 'A', 'LastName': 'Schoenthaler', 'Affiliation': 'Department of Population Health, Center for Healthful Behavior Change, New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bergman', 'Affiliation': 'Department of Population Health, Center for Healthful Behavior Change, New York University School of Medicine, New York, NY, USA; Department of Medicine, Division of Endocrinology, Diabetes, and Metabolism, New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Ann Marie', 'Initials': 'AM', 'LastName': 'Schmidt', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Diabetes, and Metabolism, New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Segal', 'Affiliation': 'Department of Computer Science and Applied Mathematics, Weizmann Institute of Science, Rehovot, Israel.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Godneva', 'Affiliation': 'Department of Computer Science and Applied Mathematics, Weizmann Institute of Science, Rehovot, Israel.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': 'Sevick', 'Affiliation': 'Department of Population Health, Center for Healthful Behavior Change, New York University School of Medicine, New York, NY, USA; Department of Medicine, Division of Endocrinology, Diabetes, and Metabolism, New York University School of Medicine, New York, NY, USA. Electronic address: mary.sevick@nyulangone.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.03.001']
951,31646767,Population Pharmacokinetic/Pharmacodynamic Modeling of Methylprednisolone in Neonates Undergoing Cardiopulmonary Bypass.,"Methylprednisolone is used in neonates to modulate cardiopulmonary bypass (CPB)-induced inflammation, but optimal dosing and exposure are unknown. We used plasma methylprednisolone and interleukin (IL)-6 and IL-10 concentrations from neonates enrolled in a randomized trial comparing one vs. two doses of methylprednisolone to develop indirect response population pharmacokinetic/pharmacodynamic models characterizing the exposure-response relationships. We applied the models to simulate methylprednisolone dosages resulting in the desired IL-6 and -10 exposures, known mediators of CPB-induced inflammation. A total of 64 neonates (median weight 3.2 kg, range 2.2-4.3) contributed 290 plasma methylprednisolone concentrations (range 1.07-12,700 ng/mL) and IL-6 (0-681 pg/mL) and IL-10 (0.1-1125 pg/mL). Methylprednisolone plasma exposure following a single 10 mg/kg intravenous dose inhibited IL-6 and stimulated IL-10 production when compared with placebo. Higher (30 mg/kg) or more frequent (twice) dosing did not confer additional benefit. Clinical efficacy studies are needed to evaluate the effect of optimized dosing on outcomes.",2019,Higher (30 mg/kg) or more frequent (twice) dosing did not confer additional benefit.,"['Neonates Undergoing Cardiopulmonary Bypass', '64 neonates (median weight 3.2\xa0kg, range 2.2-4.3) contributed 290 plasma methylprednisolone concentrations (range 1.07-12,700\xa0ng/mL) and IL-6 (0-681\xa0pg/mL) and IL-10 (0.1-1125\xa0pg/mL']","['plasma methylprednisolone and interleukin (IL)-6 and IL-10 concentrations', 'placebo', 'Methylprednisolone', 'methylprednisolone']",['IL-6 and stimulated IL-10 production'],"[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C4517759', 'cui_str': 'Four point three'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0439297', 'cui_str': 'pg/mL'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0033268'}]",,0.235628,Higher (30 mg/kg) or more frequent (twice) dosing did not confer additional benefit.,"[{'ForeName': 'Christoph P', 'Initials': 'CP', 'LastName': 'Hornik', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gonzalez', 'Affiliation': 'Division of Pharmacotherapy and Experimental Therapeutics, University of North Carolina Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Dumond', 'Affiliation': 'Division of Pharmacotherapy and Experimental Therapeutics, University of North Carolina Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Huali', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Graham', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Hill', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cohen-Wolkowiez', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}]",CPT: pharmacometrics & systems pharmacology,['10.1002/psp4.12470']
952,31765988,Dual Erb B Inhibition in Oesophago-gastric Cancer (DEBIOC): A phase I dose escalating safety study and randomised dose expansion of AZD8931 in combination with oxaliplatin and capecitabine chemotherapy in patients with oesophagogastric adenocarcinoma.,"BACKGROUND


AZD8931 has equipotent activity against epidermal growth factor receptor, erbB2, and erbB3. Primary objectives were to determine the recommended phase II dose (RP2D) of AZD8931 + chemotherapy, and subsequently assess safety/preliminary clinical activity in patients with operable oesophagogastric cancer (OGC).
METHODS


AZD8931 (20 mg, 40 mg or 60 mg bd) was given with Xelox (oxaliplatin + capecitabine) for eight 21-day cycles, continuously or with intermittent schedule (4 days on/3 off every week; 14 days on/7 off, per cycle) in a rolling-six design. Subsequently, patients with OGC were randomised 2:1 to AZD8931 + Xelox at RP2D or Xelox only for two cycles, followed by radical oesophagogastric surgery. Secondary outcomes were safety, complete resection (R0) rate, six-month progression-free survival (PFS) and overall survival.
RESULTS


During escalation, four dose-limiting toxicities were observed among 24 patients: skin rash (1) and failure to deliver 100% of Xelox because of treatment-associated grade III-IV adverse events (AEs) (3: diarrhoea and vomiting; vomiting; fatigue). Serious adverse events (SAE) occurred in 15 of 24 (63%) patients. RP2D was 20-mg bd with the 4/3 schedule. In the expansion phase, 2 of 20 (10%) patients in the Xelox + AZD8931 group and 5/10 (50%) patients in the Xelox group had grade III-IV AEs. Six-month PFS was 85% (90% CI: 66%-94%) in Xelox + AZD8931 and 100% in Xelox alone. Seven deaths (35%) occurred with Xelox + AZD8931 and one (10%) with Xelox. R0 rate was 45% (9/20) with Xelox + AZD8931 and 90% (9/10) with Xelox-alone (P = 0.024).
CONCLUSION


Xelox + AZD8931 (20 mg bd 4/3 days) has an acceptable safety profile administered as neoadjuvant therapy in operable patients with OGC. (Trial registration: EudraCT 2011-003169-13, ISRCTN-68093791).",2020,Six-month PFS was 85% (90% CI: 66%-94%) in Xelox + AZD8931 and 100% in Xelox alone.,"['Oesophago-gastric Cancer (DEBIOC', 'patients with OGC', 'patients with operable oesophagogastric cancer (OGC', 'AZD8931 ', '24 patients', 'operable patients with OGC', 'patients with oesophagogastric adenocarcinoma']","['oxaliplatin and capecitabine chemotherapy', 'RP2D', 'AZD8931', 'Xelox (oxaliplatin\xa0+\xa0capecitabine', 'AZD8931\xa0+\xa0Xelox at RP2D or Xelox', 'Xelox\xa0+\xa0AZD8931 ']","['skin rash', 'safety/preliminary clinical activity', 'grade III-IV adverse events (AEs', 'safety, complete resection (R0) rate, six-month progression-free survival (PFS) and overall survival', 'R0 rate', 'Serious adverse events (SAE']","[{'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205188', 'cui_str': 'Operable (qualifier value)'}, {'cui': 'C0475468', 'cui_str': 'Esophagogastric (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2703086', 'cui_str': 'AZD8931'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C2703086', 'cui_str': 'AZD8931'}, {'cui': 'C1956962', 'cui_str': 'XELOX'}]","[{'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439611', 'cui_str': 'Preliminary (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0464859,Six-month PFS was 85% (90% CI: 66%-94%) in Xelox + AZD8931 and 100% in Xelox alone.,"[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Thomas', 'Affiliation': 'University of Leicester, Leicester, UK. Electronic address: at107@le.ac.uk.'}, {'ForeName': 'Pradeep S', 'Initials': 'PS', 'LastName': 'Virdee', 'Affiliation': 'Centre for Statistics in Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Eatock', 'Affiliation': 'Belfast City Hospital, Belfast, UK.'}, {'ForeName': 'Simon R', 'Initials': 'SR', 'LastName': 'Lord', 'Affiliation': 'University of Oxford, Oxford, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Falk', 'Affiliation': 'Bristol Haematology & Oncology Centre, Bristol, UK.'}, {'ForeName': 'D Alan', 'Initials': 'DA', 'LastName': 'Anthoney', 'Affiliation': 'St. James University Hospital, Leeds, UK.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Turkington', 'Affiliation': 'Centre for Cancer Research and Cell Biology, Queens University Belfast, Belfast, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Goff', 'Affiliation': 'Oncology Clinical Trials Office, University of Oxford, Oxford, UK.'}, {'ForeName': 'Leena', 'Initials': 'L', 'LastName': 'Elhussein', 'Affiliation': 'Centre for Statistics in Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Collins', 'Affiliation': 'Oncology Clinical Trials Office, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Love', 'Affiliation': 'Centre for Statistics in Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Moschandreas', 'Affiliation': 'Centre for Statistics in Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Middleton', 'Affiliation': 'University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, UK.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.10.010']
953,31409568,Radiofrequency Ablation Duration per Tumor Volume May Correlate with Overall Survival in Solitary Hepatocellular Carcinoma Patients Treated with Radiofrequency Ablation Plus Lyso-Thermosensitive Liposomal Doxorubicin.,"PURPOSE


To determine whether burn time per tumor volume (BPV) (min/mL), where burn time is the total time during which radiofrequency (RF) energy is being applied, is correlated with hepatocellular carcinoma (HCC) treatment outcomes using RF ablation and lyso-thermosensitive liposomal doxorubicin (LTLD).
MATERIALS AND METHODS


The HEAT study was a double-blind, randomized controlled phase III trial of RF ablation only versus RF ablation + LTLD in patients with HCCs 3-7 cm in diameter. Effect of BPV on progression-free survival and overall survival (OS) was analyzed.
RESULTS


BPV demonstrated statistically significant differences between study groups for OS (P = .038, hazard ratio [HR] = 0.85), but not for progression-free survival (P = .389, HR = 1.059). In a separate analysis, treatment groups were independently analyzed to determine the effect of BPV within each individual group. OS improved as BPV increased for patients receiving RF ablation + LTLD (P = .017, HR = 0.836, confidence interval [0.722, 0.968]). This same association was not observed in patients receiving RF ablation only (P = .57, HR = 0.99).
CONCLUSIONS


BPV may be a useful metric for RF ablation + LTLD combination therapy for solitary HCC. The analysis suggested that the burn time for the tumor needs to be adjusted depending on the tumor volume. Because this is a post hoc study, the results are only suggestive and need to be confirmed with prospective studies.",2019,"OS improved as BPV increased for patients receiving RF ablation + LTLD (P = .017, HR = 0.836, confidence interval [0.722, 0.968]).","['patients with HCCs 3-7 cm in diameter', 'Solitary Hepatocellular Carcinoma Patients']","['RF ablation and lyso-thermosensitive liposomal doxorubicin (LTLD', 'RF Ablation Plus Lyso-thermosensitive Liposomal Doxorubicin', 'RF ablation', 'RF ablation\xa0+ LTLD', 'BPV', 'Radiofrequency Ablation Duration per Tumor Volume']","['BPV', 'progression-free survival and overall survival (OS', 'progression-free survival', 'Overall Survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}]","[{'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0531207', 'cui_str': 'bpV(phen)'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0475276', 'cui_str': 'Tumor Volume'}]","[{'cui': 'C0531207', 'cui_str': 'bpV(phen)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0779831,"OS improved as BPV increased for patients receiving RF ablation + LTLD (P = .017, HR = 0.836, confidence interval [0.722, 0.968]).","[{'ForeName': 'Haydar', 'Initials': 'H', 'LastName': 'Celik', 'Affiliation': 'Radiology and Imaging Sciences, Clinical Center, National Institutes of Health, 9000 Rockville Pike, Building 10, Room 3N320, Bethesda, MD 20892. Electronic address: haydar.celik@nih.gov.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Wakim', 'Affiliation': 'Biostatistics and Clinical Epidemiology Service, Clinical Center, National Institutes of Health, 9000 Rockville Pike, Building 10, Room 3N320, Bethesda, MD 20892.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Pritchard', 'Affiliation': 'Radiology and Imaging Sciences, Clinical Center, National Institutes of Health, 9000 Rockville Pike, Building 10, Room 3N320, Bethesda, MD 20892.'}, {'ForeName': 'Meryll', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'Radiology and Imaging Sciences, Clinical Center, National Institutes of Health, 9000 Rockville Pike, Building 10, Room 3N320, Bethesda, MD 20892.'}, {'ForeName': 'Shelby', 'Initials': 'S', 'LastName': 'Leonard', 'Affiliation': 'Radiology and Imaging Sciences, Clinical Center, National Institutes of Health, 9000 Rockville Pike, Building 10, Room 3N320, Bethesda, MD 20892.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Karanian', 'Affiliation': 'Radiology and Imaging Sciences, Clinical Center, National Institutes of Health, 9000 Rockville Pike, Building 10, Room 3N320, Bethesda, MD 20892.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Dewhirst', 'Affiliation': 'Duke Cancer Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Lencioni', 'Affiliation': 'Division of Diagnostic Imaging and Intervention, Pisa University School of Medicine, Pisa, Italy.'}, {'ForeName': 'Bradford J', 'Initials': 'BJ', 'LastName': 'Wood', 'Affiliation': 'Radiology and Imaging Sciences, Clinical Center, National Institutes of Health, 9000 Rockville Pike, Building 10, Room 3N320, Bethesda, MD 20892.'}]",Journal of vascular and interventional radiology : JVIR,['10.1016/j.jvir.2019.04.023']
954,31455249,Lateral femoral cutaneous nerve block with different volumes of Ropivacaine: a randomized trial in healthy volunteers.,"BACKGROUND


Nerve block of the lateral femoral cutaneous nerve (LFCN) is a predominantly sensory block. It reduces pain following total hip arthroplasty (THA), but the non-responder rate is high. We hypothesized, that an increased volume of ropivacaine, would result in greater coverage of incisions used for THA.
METHODS


We conducted a randomized, blinded trial in 20 healthy volunteers. Participants were randomized to receive bilateral LFCN-blocks with 8 mL ropivacaine 0.75% on the left side and 16 mL ropivacaine 0.75% on the right side, or vice versa. Allocation was blinded to both participants and outcome assessors. Before nerve block performance, incision lines for posterior and lateral THA approaches were depicted with invisible ultraviolet-paint, thereby securing sufficient blinding during outcome assessment. The blocked area was mapped using temperature and mechanical discrimination tests. Quadriceps muscle strength was monitored. Primary outcome was coverage of the posterior incision line assessed by temperature discrimination test.
RESULTS


We found no difference in coverage of the posterior or lateral incision lines when comparing LFCN-blocks with 8 mL versus 16 mL of ropivacaine. The blocked area was significantly larger in the 16 mL group, assessed by both temperature discrimination test (p = 0.012) and mechanical discrimination test (p = 0.034). We observed no difference between groups regarding quadriceps muscle strength (p = 1.0).
CONCLUSIONS


A LFCN-block with increased volume of ropivacaine from 8 mL to 16 mL did not result in a greater coverage of posterior or lateral incision lines used for THA, but in a larger blocked sensory area.
TRIAL REGISTRATION


Clinicaltrials.gov: NCT03138668 . Registered 3rd of May 2017.",2019,"The blocked area was significantly larger in the 16 mL group, assessed by both temperature discrimination test (p = 0.012) and mechanical discrimination test (p = 0.034).","['20 healthy volunteers', 'healthy volunteers']","['bilateral LFCN-blocks with 8\u2009mL ropivacaine', 'Ropivacaine', 'ropivacaine', 'mL ropivacaine']","['Quadriceps muscle strength', 'pain', 'coverage of the posterior or lateral incision lines', 'coverage of the posterior incision line assessed by temperature discrimination test', 'coverage of posterior or lateral incision lines', 'quadriceps muscle strength', 'mechanical discrimination test']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0423558', 'cui_str': 'Temperature discrimination, function (observable entity)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}]",20.0,0.252208,"The blocked area was significantly larger in the 16 mL group, assessed by both temperature discrimination test (p = 0.012) and mechanical discrimination test (p = 0.034).","[{'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Vilhelmsen', 'Affiliation': 'Department of Anesthesiology, Naestved Hospital, Naestved, Denmark. frederik.vilhelmsen@hotmail.com.'}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Nersesjan', 'Affiliation': 'Department of Anesthesiology, Naestved Hospital, Naestved, Denmark.'}, {'ForeName': 'Jakob Hessel', 'Initials': 'JH', 'LastName': 'Andersen', 'Affiliation': 'CAR, Department of Anesthesiology, Centre of Anaesthesiological Research -ZealandUniversity Hospital, Koege, Denmark.'}, {'ForeName': 'Jakob Klim', 'Initials': 'JK', 'LastName': 'Danker', 'Affiliation': 'CAR, Department of Anesthesiology, Centre of Anaesthesiological Research -ZealandUniversity Hospital, Koege, Denmark.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Broeng', 'Affiliation': 'Department of Orthopedics, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hägi-Pedersen', 'Affiliation': 'Department of Anesthesiology, Naestved Hospital, Naestved, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Mathiesen', 'Affiliation': 'CAR, Department of Anesthesiology, Centre of Anaesthesiological Research -ZealandUniversity Hospital, Koege, Denmark.'}, {'ForeName': 'Kasper Højgaard', 'Initials': 'KH', 'LastName': 'Thybo', 'Affiliation': 'Department of Anesthesiology, Naestved Hospital, Naestved, Denmark.'}]",BMC anesthesiology,['10.1186/s12871-019-0833-4']
955,31455295,"A small dose of remifentanil pretreatment suppresses sufentanil-induced cough during general anesthesia induction: a randomized, double-blind, placebo-controlled trial.","BACKGROUND


Intravenous use of sufentanil can elicit cough. This study aimed to evaluate the inhibitory effect of pre-injection of a mall dose of remifentanil on sufentanil-induced cough during the induction of general anesthesia.
METHODS


This prospective, randomized, controlled trial was conducted from January 10, 2019 to March 01, 2019. A total of 100 patients undergoing elective surgery under general anesthesia were enrolled, and at last 84 patients were included and randomly allocated into two equal size groups (n = 42): Patients in the Remifentanil group (R group) received an intravenous infusion of remifentanil 0.3 μg/kg (diluted to 2 ml) 1 min before sufentanil injection; patients in the Control group (C group) received 2 ml of normal saline (NS) at the same time point. Injections of patients in both groups were completed within 5 s. Then, sufentanil 0.5 μg/kg was injected within 5 s and the number of coughs that occurred within 1 min after sufentanil injection were recorded. One minute after sufentanil injection, etomidate 0.3 mg/kg and cisatracurium 0.15 mg/kg were given for general anesthesia induction irrespective of the presence or absence of cough. The mean arterial pressure (MAP) and heart rate (HR) at time points just before remifentanil pretreatment administration (T0), 3 min after administration (T1), 1 min after intubation (T2), and 3 min after intubation (T3) were recorded.
RESULTS


The incidence of cough in patients in the R group and C group was 4.8 and 31%, respectively. Compared with group C, the incidence and severity of cough in group R was significantly lower (P < 0.01). No significant differences were observed in MAP and HR at the time of general anesthesia induction between the two groups (P > 0.05).
CONCLUSION


Pretreatment with a small dose of remifentanil effectively and safely reduced the incidence and severity of cough induced by sufentanil during anesthesia induction and can be used as an alternative treatment to inhibit coughing caused by sufentanil.
TRIAL REGISTRATION


Chinese Clinical Trial Registry (ChiCTR1900020587, registered date: January 9, 2019), http://www.chictr.org.cn.",2019,"Compared with group C, the incidence and severity of cough in group R was significantly lower (P < 0.01).","['100 patients undergoing elective surgery under general anesthesia were enrolled, and at last 84 patients', 'January 10, 2019 to March 01, 2019', 'induced cough during general anesthesia induction']","['remifentanil', 'placebo', 'Remifentanil', 'sufentanil injection, etomidate 0.3\u2009mg/kg and cisatracurium', 'intravenous infusion of remifentanil 0.3\u2009μg/kg (diluted to 2\u2009ml) 1\u2009min before sufentanil injection; patients in the Control group (C group) received 2\u2009ml of normal saline (NS', 'sufentanil']","['mean arterial pressure (MAP) and heart rate (HR', 'incidence of cough', 'incidence and severity of cough', 'MAP and HR at the time of general anesthesia induction']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}]","[{'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4283241', 'cui_str': 'Sufentanil Injection'}, {'cui': 'C0015131', 'cui_str': 'Etomidate'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C1096766', 'cui_str': 'Cisatracurium'}, {'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}]","[{'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}]",100.0,0.415019,"Compared with group C, the incidence and severity of cough in group R was significantly lower (P < 0.01).","[{'ForeName': 'Wendong', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, 325000, China.'}, {'ForeName': 'Jiehao', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, 325000, China.'}, {'ForeName': 'Shuying', 'Initials': 'S', 'LastName': 'Fu', 'Affiliation': ""Department of Anesthesiology, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, 325000, China. fushuying2007@sina.com.""}]",BMC anesthesiology,['10.1186/s12871-019-0836-1']
956,31470796,Effect of endotracheal tube lubrication on cuff pressure increase during nitrous oxide exposure: a laboratory and prospective randomized controlled trial.,"BACKGROUND


We previously demonstrated that lubrication of an endotracheal tube (ETT) cuff with K-Y™ jelly strongly and significantly inhibited the increase in cuff pressure during nitrous oxide (N 2 O) exposure in vitro. However, in our previous study, we identified critical differences between some influential factors, such as the amount of lubricant retained on the cuff, and studied temperature differences between laboratory and clinical conditions. Therefore, it remained unclear whether this effect holds true in clinical settings.
METHODS


We first sought to study how changes in the amount of K-Y™ jelly and temperature influence the inhibitory effects of the lubricant on the increase in N 2 O-induced cuff pressure in vitro. Furthermore, we aimed to determine whether the application of K-Y™ jelly inhibits the increase in ETT cuff pressure during general anesthesia using N 2 O in adult patients.
RESULTS


In the laboratory studies, we found that K-Y™ jelly inhibited the cuff pressure increase dose-dependently when the dose of K-Y™ jelly was varied (P = 0.02), and that such an inhibitory effect decreased with an increase in the studied temperature (P = 0.019). In the clinical study, lubrication with K-Y™ jelly slightly, but significantly, delayed the increase in ETT cuff pressure during general anesthesia with N 2 O (P = 0.029). However, the inhibitory effect in the clinical settings was smaller than that in vitro.
CONCLUSIONS


Lubrication of the ETT cuff with K-Y™ jelly may delay the increase in cuff pressure during general anaesthesia with N 2 O. However, the clinical significance of this effect may be limited.
TRIAL REGISTRATION


UMIN Clinical Trials Registry: UMIN000031377 on March 1, 2019.",2019,"In the clinical study, lubrication with K-Y™ jelly slightly, but significantly, delayed the increase in ETT cuff pressure during general anesthesia with N 2 O (P = 0.029).",['adult patients'],"['nitrous oxide exposure', 'endotracheal tube lubrication']","['cuff pressure', 'cuff pressure increase dose', 'cuff pressure increase', 'ETT cuff pressure']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube, device (physical object)'}, {'cui': 'C1318469', 'cui_str': 'Lubrication'}]","[{'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",,0.0337521,"In the clinical study, lubrication with K-Y™ jelly slightly, but significantly, delayed the increase in ETT cuff pressure during general anesthesia with N 2 O (P = 0.029).","[{'ForeName': 'Moriyoshi', 'Initials': 'M', 'LastName': 'Oji', 'Affiliation': 'Department of Anesthesia, Tomei Atsugi Hospital, Atsugi, Japan.'}, {'ForeName': 'Yukihide', 'Initials': 'Y', 'LastName': 'Koyama', 'Affiliation': 'Department of Anesthesia, Tomei Atsugi Hospital, Atsugi, Japan. yukihidekoyama1008@gmail.com.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Oshika', 'Affiliation': 'Department of Anesthesia, Tomei Atsugi Hospital, Atsugi, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Kohno', 'Affiliation': 'Department of Anesthesia, Tomei Atsugi Hospital, Atsugi, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Nakahashi', 'Affiliation': 'Department of Anesthesia, Tomei Atsugi Hospital, Atsugi, Japan.'}, {'ForeName': 'Sayano', 'Initials': 'S', 'LastName': 'Fukushima', 'Affiliation': 'Department of Anesthesia, Tomei Atsugi Hospital, Atsugi, Japan.'}, {'ForeName': 'Hidemasa', 'Initials': 'H', 'LastName': 'Iwakura', 'Affiliation': 'Department of Anesthesia, Tomei Atsugi Hospital, Atsugi, Japan.'}, {'ForeName': 'Tomio', 'Initials': 'T', 'LastName': 'Andoh', 'Affiliation': 'Department of Anesthesiology, Mizonokuchi Hospital, Teikyo University School of Medicine, 5-1-1 Futako, Takatsu-ku, Kawasaki, Kanagawa Prefecture, 213-8507, Japan.'}]",BMC anesthesiology,['10.1186/s12871-019-0837-0']
957,30725077,Association of the Youth-Nominated Support Team Intervention for Suicidal Adolescents With 11- to 14-Year Mortality Outcomes: Secondary Analysis of a Randomized Clinical Trial.,"Importance


The prevalence of suicide among adolescents is rising, yet little is known about effective interventions. To date, no intervention for suicidal adolescents has been shown to reduce mortality.
Objective


To determine whether the Youth-Nominated Support Team Intervention for Suicidal Adolescents-Version II (YST) is associated with reduced mortality 11 to 14 years after psychiatric hospitalization for suicide risk.
Design, Setting, and Participants


This post hoc secondary analysis of a randomized clinical trial used National Death Index (NDI) data from adolescent psychiatric inpatients from 2 US psychiatric hospitals enrolled in the clinical trial from November 10, 2002, to October 26, 2005. Eligible participants were aged 13 to 17 years and presented with suicidal ideation (frequent or with suicidal plan), a suicide attempt, or both within the past 4 weeks. Participants were randomized to receive treatment as usual (TAU) or YST plus TAU (YST). Evaluators and staff who matched identifying data to NDI records were masked to group. The length of NDI follow-up ranged from 11.2 to 14.1 years. Analyses were conducted between February 12, 2018, and September 18, 2018.
Interventions


The YST is a psychoeducational, social support intervention. Adolescents nominated ""caring adults"" (mean, 3.4 per adolescent from family, school, and community) to serve as support persons for them after hospitalization. These adults attended a psychoeducational session to learn about the youth's problem list and treatment plan, suicide warning signs, communicating with adolescents, and how to be helpful in supporting treatment adherence and positive behavioral choices. The adults received weekly supportive telephone calls from YST staff for 3 months.
Main Outcomes and Measures


Survival 11 to 14 years after index hospitalization, measured by NDI data for deaths (suicide, drug overdose, and other causes of premature death), from January 1, 2002, through December 31, 2016.
Results


National Death Index records were reviewed for all 448 YST study participants (319 [71.2%] identified as female; mean [SD] age, 15.6 [1.3] years; 375 [83.7%] of white race/ethnicity). There were 13 deaths in the TAU group and 2 deaths in the YST group (hazard ratio, 6.62; 95% CI, 1.49-29.35; P < .01). No patients were withdrawn from YST owing to adverse effects.
Conclusions and Relevance


The findings suggest that the YST intervention for suicidal adolescents is associated with reduced mortality. Because this was a secondary analysis, results warrant replication with examination of mechanisms.
Trial Registration


ClinicalTrials.gov identifier: NCT00071617.",2019,"There were 13 deaths in the TAU group and 2 deaths in the YST group (hazard ratio, 6.62; 95% CI, 1.49-29.35; P < .01).","['Eligible participants were aged 13 to 17 years and presented with suicidal ideation (frequent or with suicidal plan), a suicide attempt, or both within the past 4 weeks', 'adolescent psychiatric inpatients from 2 US psychiatric hospitals enrolled in the clinical trial from November 10, 2002, to October 26, 2005', 'Suicidal Adolescents-Version II (YST', 'suicidal adolescents', 'Suicidal Adolescents', 'Results\n\n\nNational Death Index records were reviewed for all 448 YST study participants (319 [71.2%] identified as female; mean [SD] age, 15.6 [1.3] years; 375 [83.7%] of white race/ethnicity', 'Adolescents nominated ""caring adults"" (mean, 3.4 per adolescent from family, school, and community) to serve as support persons for them after hospitalization']","['usual (TAU) or YST plus TAU (YST', 'supportive telephone calls from YST staff', 'YST intervention', 'Youth-Nominated Support Team Intervention', 'YST']","['Measures\n\n\nSurvival 11 to 14 years after index hospitalization, measured by NDI data for deaths (suicide, drug overdose, and other causes of premature death', 'mortality']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0424001', 'cui_str': 'Planning suicide (finding)'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt (event)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0748064', 'cui_str': 'Psychiatric inpatient'}, {'cui': 'C0020021', 'cui_str': 'Mental Hospitals'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0438696', 'cui_str': 'Suicidal (finding)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}, {'cui': 'C4517745', 'cui_str': '375 (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517692', 'cui_str': '3.4 (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0029944', 'cui_str': 'Drug Overdose'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C1855073', 'cui_str': 'Death, Premature'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.237827,"There were 13 deaths in the TAU group and 2 deaths in the YST group (hazard ratio, 6.62; 95% CI, 1.49-29.35; P < .01).","[{'ForeName': 'Cheryl A', 'Initials': 'CA', 'LastName': 'King', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Arango', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kramer', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Busby', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Czyz', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor.'}, {'ForeName': 'Cynthia Ewell', 'Initials': 'CE', 'LastName': 'Foster', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor.'}, {'ForeName': 'Brenda W', 'Initials': 'BW', 'LastName': 'Gillespie', 'Affiliation': 'Consulting for Statistics, Computing and Analytics Research at the University of Michigan, Ann Arbor.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA psychiatry,['10.1001/jamapsychiatry.2018.4358']
958,31164366,Rationale and design of OPtimising thERapy to prevent Avoidable hospital admissions in Multimorbid older people (OPERAM): a cluster randomised controlled trial.,"INTRODUCTION


Multimorbidity and polypharmacy are important risk factors for drug-related hospital admissions (DRAs). DRAs are often linked to prescribing problems (overprescribing and underprescribing), as well as non-adherence with drug regimens for different reasons. In this trial, we aim to assess whether a structured medication review compared with standard care can reduce DRAs in multimorbid older patients with polypharmacy.
METHODS AND ANALYSIS


OPtimising thERapy to prevent Avoidable hospital admissions in Multimorbid older people is a European multicentre, cluster randomised, controlled trial. Hospitalised patients ≥70 years with ≥3 chronic medical conditions and concurrent use of ≥5 chronic medications are included in the four participating study centres of Bern (Switzerland), Utrecht (The Netherlands), Brussels (Belgium) and Cork (Ireland). Patients treated by the same prescribing physician constitute a cluster, and clusters are randomised 1:1 to either standard care or Systematic Tool to Reduce Inappropriate Prescribing (STRIP) intervention with the help of a clinical decision support system, the STRIP Assistant. STRIP is a structured method performing customised medication reviews, based on Screening Tool of Older People's Prescriptions/Screening  Tool to Alert to Right Treatment criteria to detect potentially inappropriate prescribing. The primary endpoint is any DRA where the main reason or a contributory reason for the patient's admission is caused by overtreatment or undertreatment, and/or inappropriate treatment. Secondary endpoints include number of any hospitalisations, all-cause mortality, number of falls, quality of life, degree of polypharmacy, activities of daily living, patient's drug compliance, the number of significant drug-drug interactions, drug overuse and underuse and potentially inappropriate medication.
ETHICS AND DISSEMINATION


The local Ethics Committees in Switzerland, Ireland, The Netherlands and Belgium approved this trial protocol. We will publish the results of this trial in a peer-reviewed journal.
MAIN FUNDING


European Union's Horizon 2020 programme.
TRIAL REGISTRATION NUMBER


NCT02986425 , SNCTP000002183 , NTR6012, U1111-1181-9400.",2019,"STRIP is a structured method performing customised medication reviews, based on Screening Tool of Older People's Prescriptions/Screening  Tool to Alert to Right Treatment criteria to detect potentially inappropriate prescribing.","['Hospitalised patients ≥70 years with ≥3\u2009chronic medical conditions and concurrent use of ≥5\u2009chronic medications are included in the four participating study centres of Bern (Switzerland), Utrecht (The Netherlands), Brussels (Belgium) and Cork (Ireland', 'Multimorbid older people (OPERAM', 'Multimorbid older people', 'multimorbid older patients with polypharmacy']","['standard care or Systematic Tool to Reduce Inappropriate', 'Prescribing (STRIP) intervention', 'standard care']","[""number of any hospitalisations, all-cause mortality, number of falls, quality of life, degree of polypharmacy, activities of daily living, patient's drug compliance, the number of significant drug-drug interactions, drug overuse and underuse and potentially inappropriate medication"", 'overtreatment or undertreatment, and/or inappropriate treatment', 'Avoidable hospital admissions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0304066', 'cui_str': 'Cork (substance)'}, {'cui': 'C0022067', 'cui_str': 'Ireland, Republic of'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2922974', 'cui_str': 'Polymedication'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0220922', 'cui_str': 'systematics'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate component (foundation metadata concept)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0575126', 'cui_str': 'Falls occurrence'}, {'cui': 'C0034380'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C2922974', 'cui_str': 'Polymedication'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C4042848', 'cui_str': 'Potentially Inappropriate Medications'}, {'cui': 'C4046039', 'cui_str': 'Overtreatment'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate component (foundation metadata concept)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}]",,0.150533,"STRIP is a structured method performing customised medication reviews, based on Screening Tool of Older People's Prescriptions/Screening  Tool to Alert to Right Treatment criteria to detect potentially inappropriate prescribing.","[{'ForeName': 'Luise', 'Initials': 'L', 'LastName': 'Adam', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Elisavet', 'Initials': 'E', 'LastName': 'Moutzouri', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Baumgartner', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Axel Lennart', 'Initials': 'AL', 'LastName': 'Loewe', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Feller', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Khadija', 'Initials': 'K', 'LastName': ""M'Rabet-Bensalah"", 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Schwab', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Hossmann', 'Affiliation': 'Clinical Trial Unit Bern, Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Schneider', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Jegerlehner', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Floriani', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Limacher', 'Affiliation': 'Clinical Trial Unit Bern, Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Katharina Tabea', 'Initials': 'KT', 'LastName': 'Jungo', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Corlina Johanna Alida', 'Initials': 'CJA', 'LastName': 'Huibers', 'Affiliation': 'Department of Geriatric Medicine and Expertise Centre Pharmacotherapy in Old Persons, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Streit', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Schwenkglenks', 'Affiliation': 'Institute of Pharmaceutical Medicine (ECPM), University of Basel, Basel, Switzerland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Spruit', 'Affiliation': 'Department of Information and Computing Sciences, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Van Dorland', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Donzé', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Kearney', 'Affiliation': 'Department of Epidemiology and Public Health, University College Cork, Cork, Ireland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': 'Clinical Trial Unit Bern, Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Drahomir', 'Initials': 'D', 'LastName': 'Aujesky', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Jansen', 'Affiliation': 'Department of Geriatric Medicine and Expertise Centre Pharmacotherapy in Old Persons, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Boland', 'Affiliation': 'Cliniques universitaires Saint-Luc, Université catholique de Louvain, Louvain, Belgium.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Dalleur', 'Affiliation': 'Cliniques universitaires Saint-Luc, Université catholique de Louvain, Louvain, Belgium.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Byrne', 'Affiliation': 'School of Pharmacy, University College Cork, Cork, Ireland.'}, {'ForeName': 'Wilma', 'Initials': 'W', 'LastName': 'Knol', 'Affiliation': 'Department of Geriatric Medicine and Expertise Centre Pharmacotherapy in Old Persons, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Spinewine', 'Affiliation': 'Louvain Drug Research Institute - Clinical Pharmacy, Université catholique de Louvain, Louvain, Belgium.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': ""O'Mahony"", 'Affiliation': 'Department of Medicine (Geriatrics), University College Cork and Cork University Hospital, Cork, Ireland.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Trelle', 'Affiliation': 'Clinical Trial Unit Bern, Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rodondi', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}]",BMJ open,['10.1136/bmjopen-2018-026769']
959,30577901,A randomized clinical trial of the Recovery Line among methadone treatment patients with ongoing illicit drug use.,"BACKGROUND


Relapse, drug use, and treatment dropout are common challenges facing patients receiving methadone. Though effective, multiple barriers to face-to-face counseling exist. The Recovery Line (RL), an automated, self-management system based on Cognitive Behavioral Therapy, is a phone-based adjunctive treatment that provides low cost, consistent delivery and immediate therapeutic availability 24 h a day.
METHODS


The current study was a 12-week randomized clinical efficacy trial of treatment-as-usual (TAU) only or RL + TAU for methadone treatment patients with continued illicit drug use (N = 82). Previous small trial phases evaluated methods to increase participant engagement and use of the RL and were incorporated into the current RL version. Primary outcomes were days of self-reported illicit drug abstinence and urine screens negative for illicit drugs.
RESULTS


Days of self-reported illicit drug abstinence improved for patients in RL + TAU but not in TAU. Percent of urine screens negative for illicit drugs, coping skills efficacy, and retention in methadone treatment did not differ by condition. Patients in RL + TAU attended more substance use disorder treatment and self-help group sessions during treatment than those in TAU. RL system use was generally low and more system use was correlated with abstinence outcomes.
CONCLUSIONS


Although the RL did not impact urine screen outcomes, it increases self-reported abstinence. Additional methods to increase patient engagement with automated, self-management systems for substance use disorder are needed.",2019,Patients in RL + TAU attended more substance use disorder treatment and self-help group sessions during treatment than those in TAU.,"['treatment patients with continued illicit drug use (N\u202f=\u202f82', 'treatment patients with ongoing illicit drug use']","['methadone', 'treatment-as-usual (TAU) only or RL\u202f+\u202fTAU for methadone']","['illicit drug abstinence', 'days of self-reported illicit drug abstinence and urine screens negative for illicit drugs']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0281875', 'cui_str': 'Illicit drug use (finding)'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0086190', 'cui_str': 'Illicit Drugs'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]",,0.041507,Patients in RL + TAU attended more substance use disorder treatment and self-help group sessions during treatment than those in TAU.,"[{'ForeName': 'Brent A', 'Initials': 'BA', 'LastName': 'Moore', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, 06511, CT, USA; VA Connecticut Healthcare System, West Haven, 06516, CT, USA; APT Foundation, New Haven, 06511, CT, USA. Electronic address: brent.moore@yale.edu.'}, {'ForeName': 'Frank D', 'Initials': 'FD', 'LastName': 'Buono', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, 06511, CT, USA; VA Connecticut Healthcare System, West Haven, 06516, CT, USA; APT Foundation, New Haven, 06511, CT, USA.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Lloyd', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, 06511, CT, USA; APT Foundation, New Haven, 06511, CT, USA.'}, {'ForeName': 'Destiny M B', 'Initials': 'DMB', 'LastName': 'Printz', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, 06511, CT, USA; VA Connecticut Healthcare System, West Haven, 06516, CT, USA; APT Foundation, New Haven, 06511, CT, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Fiellin', 'Affiliation': 'Department of Internal Medicine, Yale University School of Medicine, New Haven, 06510, CT, USA.'}, {'ForeName': 'Declan T', 'Initials': 'DT', 'LastName': 'Barry', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, 06511, CT, USA; APT Foundation, New Haven, 06511, CT, USA.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2018.11.011']
960,30043658,Efficacy and safety of ozanimod in multiple sclerosis: Dose-blinded extension of a randomized phase II study.,"BACKGROUND


Ozanimod, an oral immunomodulator, selectively targets sphingosine 1-phosphate receptors 1 and 5.
OBJECTIVE


Evaluate efficacy, safety, and tolerability of ozanimod in relapsing multiple sclerosis.
METHODS


In the RADIANCE Part A phase II study (NCT01628393), participants with relapsing multiple sclerosis were randomized (1:1:1) to once-daily ozanimod hydrochloride (0.5 or 1 mg) or placebo. After 24 weeks, participants could enter a 2-year, dose-blinded extension. Ozanimod-treated participants continued their assigned dose; placebo participants were re-randomized (1:1) to ozanimod hydrochloride 0.5 or 1 mg (equivalent to ozanimod 0.46 and 0.92 mg).
RESULTS


A total of 223 (89.6%) of the 249 participants completed the blinded extension. At 2 years of the extension, the percentage of participants who were gadolinium-enhancing lesion-free ranged from 86.5% to 94.6%. Unadjusted annualized relapse rate during the blinded extension (week 24-end of treatment) was 0.32 for ozanimod hydrochloride 0.5 mg → ozanimod hydrochloride 0.5 mg, 0.18 for ozanimod hydrochloride 1 mg → ozanimod hydrochloride 1 mg, 0.30 for placebo → ozanimod hydrochloride 0.5 mg, and 0.18 for placebo → ozanimod hydrochloride 1 mg. No second-degree or higher atrioventricular block or serious opportunistic infection was reported.
CONCLUSION


Ozanimod demonstrated sustained efficacy in participants continuing treatment up to 2 years and reached similar efficacy in participants who switched from placebo; no unexpected safety signals emerged.",2019,"No second-degree or higher atrioventricular block or serious opportunistic infection was reported.
","['multiple sclerosis', 'participants with relapsing multiple sclerosis', 'A total of 223 (89.6%) of the 249 participants completed the blinded extension']","['ozanimod hydrochloride 1\u2009mg → ozanimod hydrochloride', 'placebo', 'ozanimod hydrochloride 0.5\u2009mg → ozanimod hydrochloride', 'ozanimod hydrochloride', 'ozanimod', 'ozanimod hydrochloride 0.5 or 1\u2009mg (equivalent to ozanimod 0.46 and 0.92\u2009mg', 'placebo → ozanimod hydrochloride']","['efficacy, safety, and tolerability', 'gadolinium-enhancing lesion-free', 'No second-degree or higher atrioventricular block or serious opportunistic infection', 'Unadjusted annualized relapse rate', 'Efficacy and safety', 'sustained efficacy']","[{'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}]","[{'cui': 'C4278675', 'cui_str': 'ozanimod'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C4517460', 'cui_str': '0.46 (qualifier value)'}, {'cui': 'C4517485', 'cui_str': '0.92'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0443298', 'cui_str': 'Second degree (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0004245', 'cui_str': 'Atrioventricular Conduction Block'}, {'cui': 'C0029118', 'cui_str': 'Opportunistic Infections'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",249.0,0.266104,"No second-degree or higher atrioventricular block or serious opportunistic infection was reported.
","[{'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Cohen', 'Affiliation': 'Mellen Center for MS Treatment and Research, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Comi', 'Affiliation': 'Department of Neurology, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Arnold', 'Affiliation': 'NeuroRx Research and Montreal Neurological Institute, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Bar-Or', 'Affiliation': 'Center for Neuroinflammation and Experimental Therapeutics and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Krzysztof W', 'Initials': 'KW', 'LastName': 'Selmaj', 'Affiliation': 'Center for Neurology, Łódź, Poland.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Steinman', 'Affiliation': 'Department of Neurology & Neurological Sciences, Beckman Center for Molecular Medicine, Stanford University Medical Center, Stanford, CA, USA.'}, {'ForeName': 'Eva K', 'Initials': 'EK', 'LastName': 'Havrdová', 'Affiliation': 'Department of Neurology and Center for Clinical Neuroscience, First Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Bruce Ac', 'Initials': 'BA', 'LastName': 'Cree', 'Affiliation': 'UCSF Weill Institute for Neurosciences and Department of Neurology, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Montalbán', 'Affiliation': ""Division of Neurology and St. Michael's Hospital, University of Toronto, Toronto, ON, Canada/Cemcat, Vall d'Hebron University Hospital and Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Hartung', 'Affiliation': 'Department of Neurology, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Huang', 'Affiliation': 'Biostatistics, Celgene Corporation, San Diego, CA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Frohna', 'Affiliation': 'Clinical Development, Celgene Corporation, San Diego, CA, USA.'}, {'ForeName': 'Brett E', 'Initials': 'BE', 'LastName': 'Skolnick', 'Affiliation': 'Clinical Development, Celgene Corporation, San Diego, CA, USA.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Kappos', 'Affiliation': 'Neurologic Clinic and Polyclinic, University Hospital of Basel and University of Basel, Basel, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458518789884']
961,30260458,"The Effect of Reducing the ""Jumping to Conclusions"" Bias on Treatment Decision-Making Capacity in Psychosis: A Randomized Controlled Trial With Mediation Analysis.","BACKGROUND


Evidence-based psychological interventions to support treatment decision-making capacity (capacity) in psychosis do not currently exist. This study sought to establish whether reducing the extent to which this group form conclusions based on limited evidence, also known as the ""jumping-to-conclusions"" (JTC) bias, could improve capacity.
METHODS


In a randomized controlled open trial, 37 patients aged 16-65 years diagnosed with schizophrenia-spectrum disorders were randomly assigned (1:1) to receive a single-session intervention designed to reduce the JTC bias (MCT-JTC; adapted from Metacognitive Training [MCT]) or an attention control (AC) condition designed to control for therapist attention, duration, modality, and face validity. Primary outcomes were treatment decision-making capacity measured by the MacArthur Competency Assessment Tool for Treatment (MacCAT-T) and the jumping-to-conclusions reasoning bias measured by draws to decision on the beads task, each of which were administered by the psychologist delivering the intervention.
RESULTS


Those receiving MCT-JTC had large improvements in overall capacity (d = 0.96, P < .05) and appreciation (d = 0.87, P < .05) compared to those receiving AC. Reduction in JTC mediated a large proportion of the effect of group allocation on understanding, appreciation, reasoning, and overall MacCAT-T scores.
CONCLUSION


This is the first experimental investigation of the effect of a psychological intervention on treatment decision-making capacity in psychosis. It provides early evidence that reducing the JTC bias is associated with large and rapid improvements in capacity. Due to limited resources, assessments were administered by the researchers delivering the intervention. Results should therefore be considered preliminary and a larger, definitive trial addressing methodological limitations is warranted.",2019,"Those receiving MCT-JTC had large improvements in overall capacity (d = 0.96, P < .05) and appreciation (d = 0.87, P < .05) compared to those receiving AC.","['Psychosis', '37 patients aged 16-65 years diagnosed with schizophrenia-spectrum disorders', 'psychosis']","['psychological intervention', 'single-session intervention designed to reduce the JTC bias (MCT-JTC; adapted from Metacognitive Training [MCT]) or an attention control (AC) condition designed to control for therapist attention, duration, modality, and face validity', 'MCT-JTC', 'Jumping to Conclusions"" Bias']","['treatment decision-making capacity measured by the MacArthur Competency Assessment Tool for Treatment (MacCAT-T) and the jumping-to-conclusions reasoning bias measured by draws to decision on the beads task', 'overall capacity']","[{'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C1173173', 'cui_str': 'N-methanocarbathymidine'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0042284', 'cui_str': 'Validity of Results'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011109', 'cui_str': 'Decision Making'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",37.0,0.100938,"Those receiving MCT-JTC had large improvements in overall capacity (d = 0.96, P < .05) and appreciation (d = 0.87, P < .05) compared to those receiving AC.","[{'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Turner', 'Affiliation': 'Department of Clinical Psychology, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Angus', 'Initials': 'A', 'LastName': 'MacBeth', 'Affiliation': 'Department of Clinical and Health Psychology, School of Health in Social Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Larkin', 'Affiliation': 'Psychosis Research Unit, Greater Manchester West Mental Health NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'Working Group on Clinical Neuropsychology, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Livingstone', 'Affiliation': 'Clinical Psychology, NHS Lanarkshire, Bothwell, Glasgow, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Campbell', 'Affiliation': 'Clinical Psychology, NHS Lanarkshire, Bothwell, Glasgow, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hutton', 'Affiliation': 'School of Health and Social Care, Edinburgh Napier University, Edinburgh, UK.'}]",Schizophrenia bulletin,['10.1093/schbul/sby136']
962,30262813,Effects of daily consumption of the probiotic Bifidobacterium animalis subsp. lactis CECT 8145 on anthropometric adiposity biomarkers in abdominally obese subjects: a randomized controlled trial.,"BACKGROUND


The effects of probiotic Bifidobacterium animalis subsp. lactis CECT 8145 (Ba8145) and those of its heat-killed form (h-k Ba8145) on human anthropometric adiposity biomarkers are unknown.
OBJECTIVE


To assess the effect of Ba8145 and h-k Ba8145 ingestion on anthropometric adiposity biomarkers.
DESIGN


Randomized, parallel, double-blind, placebo-controlled trial with abdominally obese individuals. Participants (n = 135) consumed 1 capsule/day containing 10 10  colony forming unit (CFU) of Ba8145, 10 10  CFU of h-k Ba8145, or placebo (maltodextrin) for 3 months.
RESULTS


Ba8145 ingestion decreased waist circumference, waist circumference/height ratio, and Conicity index (P < 0.05) versus its baseline. Changes versus the placebo group reached significance (P < 0.05) after the h-k Ba8145 treatment. Ba8145 decreased the body mass index compared with baseline and placebo group (P < 0.05). The decrease in visceral fat area after Ba8145 treatments reached significance (P < 0.05) only after h-k Ba8145. When analyses by gender were performed, significance remained only for women. Diastolic blood pressure and HOMA index decreased (P < 0.05) after h-k Ba8145. Gut microbiome analyses showed an increase in Akkermansia spp. after Ba8145 treatment, particularly in the live form, which was inversely related to weight (P = 0.003).
CONCLUSIONS


In abdominally obese individuals, consumption of Ba8145, both as viable and mainly as heat-killed cells, improves anthropometric adiposity biomarkers, particularly in women. An increase in the gut Akkermansia genus appears as a possible mechanism involved. Our results support Ba8145 probiotic as a complementary strategy in obesity management.",2019,Changes versus the placebo group reached significance (P < 0.05) after the h-k Ba8145 treatment.,"['abdominally obese subjects', 'abdominally obese individuals']","['probiotic Bifidobacterium animalis subsp', 'lactis CECT', 'placebo (maltodextrin', 'placebo', 'Ba8145 and h-k Ba8145 ingestion']","['Diastolic blood pressure and HOMA index', 'visceral fat area', 'anthropometric adiposity biomarkers', 'waist circumference, waist circumference/height ratio, and Conicity index', 'body mass index', 'Akkermansia spp']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1490589', 'cui_str': 'Genus Akkermansia (organism)'}, {'cui': 'C0075148', 'cui_str': 'stable plasma protein solution'}]",,0.269698,Changes versus the placebo group reached significance (P < 0.05) after the h-k Ba8145 treatment.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Pedret', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Reus, Spain.'}, {'ForeName': 'Rosa M', 'Initials': 'RM', 'LastName': 'Valls', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Reus, Spain. rosamaria.valls@urv.cat.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Calderón-Pérez', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Reus, Spain.'}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Llauradó', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Reus, Spain.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Companys', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Reus, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pla-Pagà', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Reus, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Moragas', 'Affiliation': 'Departament de Medicina i Cirurgia, Universitat Rovira i Virgili, Reus, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Martín-Luján', 'Affiliation': 'Departament de Medicina i Cirurgia, Universitat Rovira i Virgili, Reus, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Ortega', 'Affiliation': 'Departament de Medicina i Cirurgia, Universitat Rovira i Virgili, Reus, Spain.'}, {'ForeName': 'Montse', 'Initials': 'M', 'LastName': 'Giralt', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Reus, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Caimari', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Reus, Spain.'}, {'ForeName': 'Empar', 'Initials': 'E', 'LastName': 'Chenoll', 'Affiliation': 'Biopolis SL/Archer Daniels Midland. R&D Department (ADM Nutrition). C/Catedrático Agustín Escardino Benlloch 9, 46980-Paterna, Valencia, Spain.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Genovés', 'Affiliation': 'Biopolis SL/Archer Daniels Midland. R&D Department (ADM Nutrition). C/Catedrático Agustín Escardino Benlloch 9, 46980-Paterna, Valencia, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Martorell', 'Affiliation': 'Biopolis SL/Archer Daniels Midland. R&D Department (ADM Nutrition). C/Catedrático Agustín Escardino Benlloch 9, 46980-Paterna, Valencia, Spain.'}, {'ForeName': 'Francisco M', 'Initials': 'FM', 'LastName': 'Codoñer', 'Affiliation': 'Lifesequencing/Archer Daniels Midland. R&D Department (ADM Nutrition). C/Catedrático Agustín Escardino Benlloch 9, 46980-Paterna, Valencia, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ramón', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Reus, Spain.'}, {'ForeName': 'Lluís', 'Initials': 'L', 'LastName': 'Arola', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Reus, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Solà', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Reus, Spain.'}]",International journal of obesity (2005),['10.1038/s41366-018-0220-0']
963,30659257,The influence of 15-week exercise training on dietary patterns among young adults.,"BACKGROUND/OBJECTIVES


Little is currently known about how exercise may influence dietary patterns and/or food preferences. The present study aimed to examine the effect of a 15-week exercise training program on overall dietary patterns among young adults.
SUBJECTS/METHODS


This study consisted of 2680 young adults drawn from the Training Intervention and Genetics of Exercise Response (TIGER) study. Subjects underwent 15 weeks of aerobic exercise training, and exercise duration, intensity, and dose were recorded for each session using computerized heart rate monitors. In total, 4355 dietary observations with 102 food items were collected using a self-administered food frequency questionnaire before and after exercise training (n = 2476 at baseline; n = 1859 at 15 weeks). Dietary patterns were identified using a Bayesian sparse latent factor model. Changes in dietary pattern preferences were evaluated based on the pre/post-training differences in dietary pattern scores, accounting for the effects of gender, race/ethnicity, and BMI.
RESULTS


Within each of the seven dietary patterns identified, most dietary pattern scores were decreased following exercise training, consistent with increased voluntary regulation of food intake. A longer duration of exercise was associated with decreased preferences for the western (β: -0.0793; 95% credible interval: -0.1568, -0.0017) and snacking (β: -0.1280; 95% credible interval: -0.1877, -0.0637) patterns, while a higher intensity of exercise was linked to an increased preference for the prudent pattern (β: 0.0623; 95% credible interval: 0.0159, 0.1111). Consequently, a higher dose of exercise was related to a decreased preference for the snacking pattern (β: -0.0023; 95% credible interval: -0.0042, -0.0004) and an increased preference for the prudent pattern (β: 0.0029; 95% credible interval: 0.0009, 0.0048).
CONCLUSIONS


The 15-week exercise training appeared to motivate young adults to pursue healthier dietary preferences and to regulate their food intake.",2019,"A longer duration of exercise was associated with decreased preferences for the western (β: -0.0793; 95% credible interval: -0.1568, -0.0017) and snacking (β:","['2680 young adults drawn from the Training Intervention and Genetics of Exercise Response (TIGER) study', 'young adults']","['15-week exercise training program', 'aerobic exercise training, and exercise duration, intensity, and dose were recorded for each session using computerized heart rate monitors', '15-week exercise training']","['voluntary regulation of food intake', 'dietary pattern preferences', 'overall dietary patterns', 'dietary pattern scores']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}]","[{'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",4355.0,0.0292461,"A longer duration of exercise was associated with decreased preferences for the western (β: -0.0793; 95% credible interval: -0.1568, -0.0017) and snacking (β:","[{'ForeName': 'Jaehyun', 'Initials': 'J', 'LastName': 'Joo', 'Affiliation': 'Department of Nutritional Sciences, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Sinead A', 'Initials': 'SA', 'LastName': 'Williamson', 'Affiliation': 'Departments of Information, Risk, & Operations Management and Statistics & Data Science, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Ana I', 'Initials': 'AI', 'LastName': 'Vazquez', 'Affiliation': 'Department of Epidemiology & Biostatistics and Institute for Quantitative Health Science and Engineering, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Jose R', 'Initials': 'JR', 'LastName': 'Fernandez', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Molly S', 'Initials': 'MS', 'LastName': 'Bray', 'Affiliation': 'Department of Nutritional Sciences, The University of Texas at Austin, Austin, TX, USA. mbray@austin.utexas.edu.'}]",International journal of obesity (2005),['10.1038/s41366-018-0299-3']
964,30418528,"Measles Immunity at 4.5 Years of Age Following Vaccination at 9 and 15-18 Months of Age Among Human Immunodeficiency Virus (HIV)-infected, HIV-exposed-uninfected, and HIV-unexposed Children.","BACKGROUND


Human immunodeficiency virus (HIV)-infected and HIV-exposed-uninfected (HEU) children may be at increased risk of measles infection due to waning of immunity following vaccination. We evaluated persistence of antibodies to measles vaccination at 4.5 years of age in HIV-unexposed, HEU, and HIV-infected children with CD4+ ≥25% previously randomized to immediate antiretroviral therapy (ART) interrupted at 12 months (HIV/Immed-ART-12), 24 months (HIV/Immed-ART-24), or when clinically/immunologically indicated (HIV/Def-ART). The HIV/Def-ART group initiated ART by median 5.8 (interquartile range, 4.4-10.3) months of age.
METHODS


In this study, HIV-unexposed (n = 95), HEU (n = 84), HIV/Immed-ART-12 (n = 70), HIV/Immed-ART-24 (n = 70), and HIV/Def-ART (n = 62) children were scheduled to receive measles vaccination at age 9 and 15-18 months. Antimeasles serum immunoglobulin G titers were quantified using enzyme-linked immunosorbent assay at 4.5 years.
RESULTS


Compared with HIV-unexposed children (2860 mIU/mL), measles antibody geometric mean titers (GMTs) were significantly lower in both HIV/Immed-ART-12 (571; P < .001) and HIV/Immed-ART-24 (1136; P < .001) but similar in the HIV/Def-ART (2777) and HEU (3242) groups. Furthermore, compared with HIV-unexposed, antibody titers ≥330 mIU/mL (ie, presumed serocorrelate for protection; 99%) were also significantly lower in HIV/Immed-ART-12 (70%; P < .001) and HIV/Immed-ART-24 (83%; P < .001) but similar in the HIV/Def-ART (90%) and HEU (98%) groups.
CONCLUSIONS


HIV-infected children in whom ART was interrupted at either 12 or 24 months had lower GMTs and lower proportions with seroprotective titers than HIV-unexposed children, indicating a potential downside of ART treatment interruption.
CLINICAL TRIALS REGISTRATION


NCT00099658 and NCT00102960.",2019,"Conclusions


HIV-infected children in whom ART was interrupted at either 12 or 24 months of age had lower GMTs and lower proportions with seroprotective titres than HIV-unexposed children; indicating a potential downside of ART treatment interruption.","['HIV-unexposed (n=95), HEU (n=84), HIV/Immed-ART-12 (n=70), HIV/Immed-ART-24 (n=70), and HIV/Def-ART (n=62) children were scheduled to receive measles vaccination at 9 and 15-18 months of age', 'Measles immunity at 4.5 years of age following vaccination at 9 and 15-18 months of age among HIV-infected, HIV-exposed-uninfected and HIV-unexposed children', '4.5 years of age in HIV-unexposed, HEU, and HIV-infected children with CD4+≥25% previously randomised to', 'participants from 6-12 weeks through 4.5 years of age']",['immediate antiretroviral therapy'],"['measles antibody geometric mean titres (GMTs', 'Anti-measles serum IgG titres']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0054282', 'cui_str': 'tribufos'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0042201', 'cui_str': 'Measles vaccination (procedure)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0025007', 'cui_str': 'Rubeola'}, {'cui': 'C0020964', 'cui_str': 'Immunity'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C1168051', 'cui_str': 'Measles antibody'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}]",,0.291677,"Conclusions


HIV-infected children in whom ART was interrupted at either 12 or 24 months of age had lower GMTs and lower proportions with seroprotective titres than HIV-unexposed children; indicating a potential downside of ART treatment interruption.","[{'ForeName': 'Eleonora A M L', 'Initials': 'EAML', 'LastName': 'Mutsaerts', 'Affiliation': 'Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Marta C', 'Initials': 'MC', 'LastName': 'Nunes', 'Affiliation': 'Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Martijn N', 'Initials': 'MN', 'LastName': 'van Rijswijk', 'Affiliation': 'Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Klipstein-Grobusch', 'Affiliation': 'Julius Global Health, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, the Netherlands.'}, {'ForeName': 'Kennedy', 'Initials': 'K', 'LastName': 'Otwombe', 'Affiliation': 'Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg.'}, {'ForeName': 'Mark F', 'Initials': 'MF', 'LastName': 'Cotton', 'Affiliation': 'Family Clinical Research Unit, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, South Africa.'}, {'ForeName': 'Avy', 'Initials': 'A', 'LastName': 'Violari', 'Affiliation': 'Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg.'}, {'ForeName': 'Shabir A', 'Initials': 'SA', 'LastName': 'Madhi', 'Affiliation': 'Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, University of the Witwatersrand, Johannesburg, South Africa.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy964']
965,30054777,"The Efficacy of an Event-Specific, Text Message, Personalized Drinking Feedback Intervention.","Tailgating drinking prior to a football game is a type of event-specific drinking associated with increased alcohol use and related problems. Personalized drinking feedback interventions (PFI) are efficacious in reducing alcohol use and problems. The current study aimed to advance understanding of event-specific interventions by examining: (1) the efficacy of an event-specific, text message PFI on tailgating alcohol outcomes, and (2) the extent to which intervention effects generalize to ""typical"" alcohol outcomes at 1-month follow-up. College students (N = 130; 71% female; 92% white) who reported tailgating within the past 30 days and binge drinking when tailgating in the past year completed assessments on tailgating and typical alcohol use. They were randomly assigned to one of two text message conditions delivered on the morning of a home football game: event-specific PFI (TXT PFI) or a control condition. Multilevel modeling examined the association of treatment condition on tailgating and 1-month alcohol outcomes. When tailgating, participants in TXT PFI reported lower estimated peak blood alcohol concentration (eBAC) and consumed less drinks than the control condition. At the 1-month ""typical"" drinking follow-up, participants in TXT PFI reported lower peak eBAC and fewer alcohol-related problems than the control condition. Perceived tailgating drinking norms were found to statistically mediate the relationship between condition and alcohol outcome at tailgating and 1-month follow-ups. Findings provide preliminary support for the efficacy of an event-specific, text message PFI in reducing both tailgating and typical drinking alcohol outcomes. Event-specific TXT PFI can be used for prevention/intervention of alcohol misuse.",2019,"At the 1-month ""typical"" drinking follow-up, participants in TXT PFI reported lower peak eBAC and fewer alcohol-related problems than the control condition.",['College students (N\u2009=\u2009130; 71% female; 92% white) who reported tailgating within the past 30\xa0days and binge drinking when tailgating in the past year completed assessments on tailgating and typical alcohol use'],"['Personalized drinking feedback interventions (PFI', 'text message conditions delivered on the morning of a home football game: event-specific PFI (TXT PFI) or a control condition', 'Event-Specific, Text Message, Personalized Drinking Feedback Intervention']",['peak blood alcohol concentration (eBAC'],"[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}]","[{'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0336986', 'cui_str': 'Football'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0684262', 'cui_str': 'Blood Alcohol Level'}]",,0.0144472,"At the 1-month ""typical"" drinking follow-up, participants in TXT PFI reported lower peak eBAC and fewer alcohol-related problems than the control condition.","[{'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Cadigan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, USA. CadiganJ@uw.edu.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Martens', 'Affiliation': 'Department of Educational, School, and Counseling Psychology, University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Dworkin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Sher', 'Affiliation': 'Department of Psychological Sciences, University of Missouri, Columbia, MO, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-018-0939-9']
966,32151512,A Comparison of Guided Video Reflection versus Self-Regulated Learning to Teach Knot Tying to Medical Students: A Pilot Randomized Controlled Trial.,"OBJECTIVES


Self-regulated learning has been proposed as a resource saving alternative for learning knot tying. However, this may be hindered by the Dunning-Kruger effect. A potential alternative is guided video reflection. The objectives of this study are to compare the performance and self-assessment abilities amongst medical students learning knot tying using either a traditional self-regulated approach versus guided video reflection.
DESIGN


This randomized, single-blinded, controlled trial used a pre-post-retention test design. All knot tying performances were video recorded and assessed nonsequentially by blinded evaluators using a modified Objective Structured Assessment of Technical Skills tool.
PARTICIPANTS


This study recruited 31 first- and second-year medical students and 6 senior urology residents from Western University in Canada.
RESULTS


At baseline, the performances of the experts were significantly higher than the experimental groups (F 3,85  = 9.080, p < 0.001). After the intervention, there was a significant increase in the performance for both experimental groups compared to the pretest period (p < 0.001). The scores between the experimental groups were not significantly different (p = 0.338). The improved performances of both groups were sustained on retention testing (p < 0.001). The self-assessment abilities were accurate for both experimental groups at baseline. However, at the post-test period the accuracy was poor (interclass correlation 0.361) for the self-regulated group, while remaining moderately (interclass correlation 0.685) accurate for the reflection group.
CONCLUSIONS


Students using guided video reflection were able to achieve competency and maintained their knot tying skills to the same degree as those who used the self-regulated approach. These results may be due to the positive effects of reflection on self-assessment abilities and subsequent improvement in goal setting for further practice.",2020,"All knot tying performances were video recorded and assessed nonsequentially by blinded evaluators using a modified Objective Structured Assessment of Technical Skills tool.
","['medical students', '31 first- and second-year medical students and 6 senior urology residents from Western University in Canada', 'to Medical Students']","['Guided Video Reflection versus Self-Regulated Learning to Teach Knot Tying', 'learning knot tying using either a traditional self-regulated approach versus guided video reflection']","['retention testing', 'performance']","[{'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C0453920', 'cui_str': 'Tie (physical object)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}]",31.0,0.0199115,"All knot tying performances were video recorded and assessed nonsequentially by blinded evaluators using a modified Objective Structured Assessment of Technical Skills tool.
","[{'ForeName': 'Peter Zhan Tao', 'Initials': 'PZT', 'LastName': 'Wang', 'Affiliation': 'Department of Surgery, Division of Urology, Western University, London, Ontario, Canada. Electronic address: peter.wang@lhsc.on.ca.'}, {'ForeName': 'Wen Yan', 'Initials': 'WY', 'LastName': 'Xie', 'Affiliation': 'Department of Surgery, Division of Urology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Shiva', 'Initials': 'S', 'LastName': 'Nair', 'Affiliation': 'Department of Surgery, Division of Urology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Sumit', 'Initials': 'S', 'LastName': 'Dave', 'Affiliation': 'Department of Surgery, Division of Urology, Western University, London, Ontario, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Shatzer', 'Affiliation': 'John Hopkins University, School of Education, Baltimore, Maryland.'}, {'ForeName': 'Saad', 'Initials': 'S', 'LastName': 'Chahine', 'Affiliation': ""Faculty of Education, Queen's University, Kingston, Ontario, Canada.""}]",Journal of surgical education,['10.1016/j.jsurg.2020.02.014']
967,30291602,Screening for Adverse Drug Events: a Randomized Trial of Automated Calls Coupled with Phone-Based Pharmacist Counseling.,"BACKGROUND


Medication adverse events are important and common yet are often not identified by clinicians. We evaluated an automated telephone surveillance system coupled with transfer to a live pharmacist to screen potentially drug-related symptoms after newly starting medications for four common primary care conditions: hypertension, diabetes, depression, and insomnia.
METHODS


Cluster randomized trial with automated calls to eligible patients at 1 and 4 months after starting target drugs from intervention primary care clinics compared to propensity-matched patients from control clinics. Primary and secondary outcomes were physician documentation of any adverse effects associated with newly prescribed target medication, and whether the medication was discontinued and, if yes, whether the reason for stopping was an adverse effect.
RESULTS


Of 4876 eligible intervention clinic patients who were contacted using automated calls, 776 (15.1%) responded and participated in the automated call. Based on positive symptom responses or request to speak to a pharmacist, 320 patients were transferred to the pharmacist and discussed 1021 potentially drug-related symptoms. Of these, 188 (18.5%) were assessed as probably and 479 (47.1%) as possibly related to the medication. Compared to a propensity-matched cohort of control clinic patients, intervention patients were significantly more likely to have adverse effects documented in the medical record by a physician (277 vs. 164 adverse effects, p < 0.0001, and 177 vs. 122 patients discontinued with documented adverse effects, p < 0.0001).
DISCUSSION


Systematic automated telephone outreach monitoring coupled with real-time phone referral to a pharmacist identified a substantial number of previously unidentified potentially drug-related symptoms, many of which were validated as probably or possibly related to the drug by the pharmacist or their physicians. Multiple challenges were encountered using the interactive voice response (IVR) automated calling system, suggesting that other approaches may need to be considered and evaluated.
TRIAL REGISTRATION


ClinicalTrials.gov : NCT02087293.",2019,"Compared to a propensity-matched cohort of control clinic patients, intervention patients were significantly more likely to have adverse effects documented in the medical record by a physician (277 vs. 164 adverse effects, p < 0.0001, and 177 vs. 122 patients discontinued with documented adverse effects, p < 0.0001).
","['Of 4876', '320 patients were transferred to the pharmacist and discussed 1021 potentially drug-related symptoms', 'eligible patients at 1 and 4\xa0months after starting target drugs from intervention primary care clinics compared to propensity-matched patients from control clinics', 'eligible intervention clinic patients who were contacted using automated calls, 776 (15.1%) responded and participated in the automated call']",['Automated Calls Coupled with Phone-Based Pharmacist Counseling'],"['adverse effects', 'adverse effect', 'physician documentation of any adverse effects associated with newly prescribed target medication']","[{'cui': 'C4517711', 'cui_str': '320 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}]",320.0,0.0590331,"Compared to a propensity-matched cohort of control clinic patients, intervention patients were significantly more likely to have adverse effects documented in the medical record by a physician (277 vs. 164 adverse effects, p < 0.0001, and 177 vs. 122 patients discontinued with documented adverse effects, p < 0.0001).
","[{'ForeName': 'Gordon D', 'Initials': 'GD', 'LastName': 'Schiff', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, USA. gschiff@partners.org.""}, {'ForeName': 'Elissa', 'Initials': 'E', 'LastName': 'Klinger', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Salazar', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Medoff', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Mary G', 'Initials': 'MG', 'LastName': 'Amato', 'Affiliation': 'Massachusetts College of Pharmacy and Health Sciences University, Boston, MA, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'John Orav', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Shimon', 'Initials': 'S', 'LastName': 'Shaykevich', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Enrique V', 'Initials': 'EV', 'LastName': 'Seoane', 'Affiliation': 'School of Pharmacy, Chapman University, Orange, CA, USA.'}, {'ForeName': 'Lake', 'Initials': 'L', 'LastName': 'Walsh', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Theresa E', 'Initials': 'TE', 'LastName': 'Fuller', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Patricia C', 'Initials': 'PC', 'LastName': 'Dykes', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Bates', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Haas', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, USA.""}]",Journal of general internal medicine,['10.1007/s11606-018-4672-7']
968,32149772,"Comparative effectiveness and safety of ribavirin plus interferon-alpha, lopinavir/ritonavir plus interferon-alpha, and ribavirin plus lopinavir/ritonavir plus interferon-alpha in patients with mild to moderate novel coronavirus disease 2019: study protocol.",,2020,,['patients with mild to moderate novel coronavirus pneumonia'],"['ribavirin plus interferon-alpha, lopinavir/ritonavir plus interferon-alpha and ribavirin plus lopinavir/ritonavir plus interferon-alphain']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'TS-COV19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]","[{'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0002199', 'cui_str': 'Interferon, Lymphoblastoid'}, {'cui': 'C0939237', 'cui_str': 'lopinavir / Ritonavir'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}]",[],,0.017903,,"[{'ForeName': 'Yan-Ming', 'Initials': 'YM', 'LastName': 'Zeng', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing 400036, China.'}, {'ForeName': 'Xiao-Lei', 'Initials': 'XL', 'LastName': 'Xu', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing 400036, China.'}, {'ForeName': 'Xiao-Qing', 'Initials': 'XQ', 'LastName': 'He', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing 400036, China.'}, {'ForeName': 'Sheng-Quan', 'Initials': 'SQ', 'LastName': 'Tang', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing 400036, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing 400036, China.'}, {'ForeName': 'Yin-Qiu', 'Initials': 'YQ', 'LastName': 'Huang', 'Affiliation': 'National Key Laboratory for Infectious Diseases Prevention and Treatment with Traditional Chinese Medicine, Chongqing Public Health Medical Center, Chongqing 400036, China.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Harypursat', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing 400036, China.'}, {'ForeName': 'Yao-Kai', 'Initials': 'YK', 'LastName': 'Chen', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing 400036, China.'}]",Chinese medical journal,['10.1097/CM9.0000000000000790']
969,31718957,"Mirabegron Add-on Therapy to Tamsulosin for the Treatment of Overactive Bladder in Men with Lower Urinary Tract Symptoms: A Randomized, Placebo-controlled Study (MATCH).","BACKGROUND


Men with lower urinary tract symptoms (LUTS) treated with α-blockers (eg, tamsulosin) may experience overactive bladder (OAB) symptoms and receive add-on antimuscarinics. Mirabegron (a β3-adrenoreceptor agonist) is an alternative add-on therapy.
OBJECTIVE


To evaluate the efficacy of mirabegron versus placebo in men with OAB symptoms receiving tamsulosin for LUTS.
DESIGN, SETTING, AND PARTICIPANTS


Japanese and Korean men with OAB treated with tamsulosin for LUTS (January 2016-July 2017).
INTERVENTION


Single-blind, 4-wk screening: tamsulosin plus placebo orally once daily; double-blind, 12-wk treatment: patients randomized (n=568) to mirabegron 50mg or placebo, as add-on to tamsulosin.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Primary endpoint: baseline to end of treatment (EoT) change in the mean number of micturitions/24h, based on a 3-d voiding diary. Secondary endpoints: change in other diary variables and patient-reported outcomes from baseline to EoT. The primary endpoint was analyzed by analysis of covariance, including treatment group and region as fixed factors and baseline as a covariate.
RESULTS AND LIMITATIONS


Mirabegron add-on therapy was superior to placebo in improving the primary endpoint (adjusted mean difference [95% confidence interval] vs placebo -0.52 [-0.82 to -0.21]) and secondary endpoints, including mean volume voided/micturition (12.08 [6.33-17.84]), OAB symptom score (-0.65 [-1.04 to -0.26]), International Prostate Symptom Score total (-1.19 [-1.94 to -0.44]), storage (-0.78 [-1.13 to -0.43]), quality of life scores (-0.29 [-0.51 to -0.07]), OAB symptom bother (-4.52 [-6.91 to -2.13]), and total health-related quality of life (2.79 [1.13 to 4.44]). Differences, compared with placebo, in urgency, urgency urinary incontinence, and nocturia were not statistically significant. Mirabegron was well tolerated, with no major safety concerns. Limitations included a lack of antimuscarinic comparison.
CONCLUSIONS


The mirabegron add-on therapy to tamsulosin for 12 wk in men with LUTS and OAB symptoms demonstrated superior efficacy to placebo and was well tolerated.
PATIENT SUMMARY


We looked at the efficacy and safety of mirabegron compared with placebo in men being treated with tamsulosin but who still had overactive bladder symptoms. Mirabegron improved overactive bladder symptoms and patient-reported outcomes compared with placebo, and was well tolerated.",2020,Mirabegron add-on therapy was superior to placebo in improving the primary endpoint (adjusted mean difference [95% confidence interval] vs placebo -0.52,"['Japanese and Korean men with OAB treated with tamsulosin for LUTS (January 2016-July 2017', 'men being treated with tamsulosin but who still had overactive bladder symptoms', 'Men with lower urinary tract symptoms (LUTS) treated with', 'men with OAB symptoms receiving tamsulosin for LUTS', 'Men with Lower Urinary Tract Symptoms']","['Placebo', 'Mirabegron (a β3-adrenoreceptor agonist', 'Tamsulosin', 'placebo', 'α-blockers (eg, tamsulosin', 'mirabegron 50mg or placebo', 'mirabegron versus placebo', 'tamsulosin plus placebo', 'tamsulosin']","['International Prostate Symptom Score total', 'tolerated', 'OAB symptom score', 'urgency, urgency urinary incontinence, and nocturia', 'efficacy and safety', 'mean volume voided/micturition', 'baseline to end of treatment (EoT) change in the mean number of micturitions/24h, based on a 3-d voiding diary', 'quality of life scores', 'overactive bladder symptoms', 'total health-related quality of life', 'OAB symptom bother']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0574785', 'cui_str': 'Lower Urinary Tract Symptoms'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2983812', 'cui_str': 'mirabegron'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C3474335', 'cui_str': 'mirabegron 50 MG'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0028734', 'cui_str': 'Nycturia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C2919691', 'cui_str': 'Treatment changed'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0034380'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",,0.490859,Mirabegron add-on therapy was superior to placebo in improving the primary endpoint (adjusted mean difference [95% confidence interval] vs placebo -0.52,"[{'ForeName': 'Hidehiro', 'Initials': 'H', 'LastName': 'Kakizaki', 'Affiliation': 'Asahikawa Medical University, Asahikawa, Japan.'}, {'ForeName': 'Kyu-Sung', 'Initials': 'KS', 'LastName': 'Lee', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Yamamoto', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Jar Jar', 'Initials': 'JJ', 'LastName': 'Jong', 'Affiliation': 'Astellas Pharma, Singapore.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Katou', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan. Electronic address: daisuke.katou@astellas.com.'}, {'ForeName': 'Budiwan', 'Initials': 'B', 'LastName': 'Sumarsono', 'Affiliation': 'Astellas Pharma, Singapore.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Uno', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Yamaguchi', 'Affiliation': 'Division of Bioengineering and LUTD Research, Nihon University School of Engineering, Koriyama, Japan.'}]",European urology focus,['10.1016/j.euf.2019.10.019']
970,30511291,Mindfulness Training Enhances Self-Regulation and Facilitates Health Behavior Change for Primary Care Patients: a Randomized Controlled Trial.,"BACKGROUND


Self-management of health is important for improving health outcomes among primary care patients with chronic disease. Anxiety and depressive disorders are common and interfere with self-regulation, which is required for disease self-management. An insurance-reimbursable mindfulness intervention integrated within primary care may be effective for enhancing chronic disease self-management behaviors among primary care patients with anxiety, depression, trauma, and stress-related and adjustment disorders compared with the increasingly standard practice of referring patients to outside mindfulness resources.
OBJECTIVE


Mindfulness Training for Primary Care (MTPC) is an 8-week, referral-based, insurance-reimbursable program integrated into safety-net health system patient-centered medical homes. We hypothesized that MTPC would be more effective for catalyzing chronic disease self-management action plan initiation within 2 weeks, versus a low-dose comparator (LDC) consisting of a 60-min mindfulness introduction, referral to community and digital resources, and addition to a 6-month waitlist for MTPC.
PARTICIPANTS


Primary care providers (PCPs) and mental health clinicians referred 465 patients over 12 months. All participants had a DSM-V diagnosis.
DESIGN AND INTERVENTIONS


Participants (N = 136) were randomized in a 2:1 allocation to MTPC (n = 92) or LDC (n = 44) in a randomized controlled comparative effectiveness trial. MTPC incorporates mindfulness, self-compassion, and mindfulness-oriented behavior change skills and is delivered as insurance-reimbursable visits within primary care. Participants took part in a chronic disease self-management action planning protocol at week 7.
MAIN MEASURES


Level of self-reported action plan initiation on the action plan initiation survey by week 9.
KEY RESULTS


Participants randomized to MTPC, relative to LDC, had significantly higher adjusted odds of self-management action plan initiation in an intention-to-treat analysis (OR = 2.28; 95% CI = 1.02 to 5.06, p = 0.025).
CONCLUSIONS


An 8-week dose of mindfulness training is more effective than a low-dose mindfulness comparator in facilitating chronic disease self-management behavior change among primary care patients.",2019,"KEY RESULTS


Participants randomized to MTPC, relative to LDC, had significantly higher adjusted odds of self-management action plan initiation in an intention-to-treat analysis (OR = 2.28; 95% CI = 1.02 to 5.06, p = 0.025).
","['Primary care providers (PCPs) and mental health clinicians referred 465 patients over 12\xa0months', 'primary care patients with anxiety, depression, trauma, and stress-related and adjustment disorders', 'Participants (N\u2009=\u2009136', 'Participants took part in a chronic disease self-management action planning protocol at week 7', 'primary care patients', 'Primary Care Patients', 'All participants had a DSM-V diagnosis', 'primary care patients with chronic disease']","['mindfulness training', 'LDC', 'Mindfulness Training for Primary Care (MTPC', 'MTPC', 'Mindfulness Training']","['Level of self-reported action plan initiation on the action plan initiation survey', 'self-management action plan initiation', 'Anxiety and depressive disorders', 'mindfulness, self-compassion, and mindfulness-oriented behavior change skills']","[{'cui': 'C2735026', 'cui_str': 'Primary care provider (occupation)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0001546', 'cui_str': 'Reactive Disorders'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1273866', 'cui_str': 'Action plan (community)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",465.0,0.0567421,"KEY RESULTS


Participants randomized to MTPC, relative to LDC, had significantly higher adjusted odds of self-management action plan initiation in an intention-to-treat analysis (OR = 2.28; 95% CI = 1.02 to 5.06, p = 0.025).
","[{'ForeName': 'Richa', 'Initials': 'R', 'LastName': 'Gawande', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, USA.'}, {'ForeName': 'My Ngoc', 'Initials': 'MN', 'LastName': 'To', 'Affiliation': 'Cambridge Health Alliance, Cambridge, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Pine', 'Affiliation': 'Cambridge Health Alliance, Cambridge, USA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Griswold', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, USA.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Creedon', 'Affiliation': 'The Heller School for Social Policy and Management, Brandeis University, Waltham, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Brunel', 'Affiliation': 'Cambridge Health Alliance, Cambridge, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Lozada', 'Affiliation': 'Cambridge Health Alliance, Cambridge, USA.'}, {'ForeName': 'Eric B', 'Initials': 'EB', 'LastName': 'Loucks', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, USA.'}, {'ForeName': 'Zev', 'Initials': 'Z', 'LastName': 'Schuman-Olivier', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, USA. zschuman@cha.harvard.edu.'}]",Journal of general internal medicine,['10.1007/s11606-018-4739-5']
971,31506096,Impact of a diet and activity health promotion intervention on regional patterns of DNA methylation.,"BACKGROUND


Studies demonstrate the impact of diet and physical activity on epigenetic biomarkers, specifically DNA methylation. However, no intervention studies have examined the combined impact of dietary and activity changes on the blood epigenome. The objective of this study was to examine the impact of the Make Better Choices 2 (MBC2) healthy diet and activity intervention on patterns of epigenome-wide DNA methylation. The MBC2 study was a 9-month randomized controlled trial among adults aged 18-65 with non-optimal levels of health behaviors. The study compared three 12-week interventions to (1) simultaneously increase exercise and fruit/vegetable intake, while decreasing sedentary leisure screen time; (2) sequentially increase fruit/vegetable intake and decrease leisure screen time first, then increase exercise; (3) increase sleep and decrease stress (control). We collected blood samples at baseline, 3 and 9 months, and measured DNA methylation using the Illumina EPIC (850 k) BeadChip. We examined region-based differential methylation patterns using linear regression models with the false discovery rate of 0.05. We also conducted pathway analysis using gene ontology (GO), KEGG, and IPA canonical pathway databases.
RESULTS


We found no differences between the MBC2 population (n = 340) and the subsample with DNA methylation measured (n = 68) on baseline characteristics or the impact of the intervention on behavior change. We identified no differentially methylated regions at baseline between the control versus intervention groups. At 3 versus 9 months, we identified 154 and 298 differentially methylated regions, respectively, between controls compared to pooled samples from sequential and simultaneous groups. In the GO database, we identified two gene ontology terms related to hemophilic cell adhesion and cell-cell adhesion. In IPA analysis, we found pathways related to carcinogenesis including PI3K/AKT, Wnt/β-catenin, sonic hedgehog, and p53 signaling. We observed an overlap between 3 and 9 months, including the GDP-L-fucose biosynthesis I, methylmalonyl metabolism, and estrogen-mediated cell cycle regulation pathways.
CONCLUSIONS


The results demonstrate that the MBC2 diet and physical activity intervention impacts patterns of DNA methylation in gene regions related to cell cycle regulation and carcinogenesis. Future studies will examine DNA methylation as a biomarker to identify populations that may particularly benefit from incorporating health behavior change into plans for precision prevention.",2019,"At 3 versus 9 months, we identified 154 and 298 differentially methylated regions, respectively, between controls compared to pooled samples from sequential and simultaneous groups.",['adults aged 18-65 with non-optimal levels of health behaviors'],"['MBC2 diet and physical activity intervention', 'simultaneously increase exercise and fruit/vegetable intake, while decreasing sedentary leisure screen time; (2) sequentially increase fruit/vegetable intake', 'diet and activity health promotion intervention', 'Make Better Choices 2 (MBC2) healthy diet and activity intervention']","['regional patterns of DNA methylation', 'behavior change', 'leisure screen time first, then increase exercise; (3) increase sleep and decrease stress (control', 'hemophilic cell adhesion and cell-cell adhesion']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake (observable entity)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}]","[{'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0376452', 'cui_str': 'DNA Methylation'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0231299', 'cui_str': 'Decreased stress (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0007577', 'cui_str': 'Cell Adhesion'}, {'cui': 'C0007634', 'cui_str': 'Cells'}]",,0.0206465,"At 3 versus 9 months, we identified 154 and 298 differentially methylated regions, respectively, between controls compared to pooled samples from sequential and simultaneous groups.","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hibler', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, 680 North Lakeshore Drive, Chicago, IL, 60611, USA. elizabeth.hibler@northwestern.edu.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Center for Research Informatics, Biological Sciences Division, University of Chicago, 900 E. 57th. Street, Chicago, IL, 60637, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Andrade', 'Affiliation': 'Center for Research Informatics, Biological Sciences Division, University of Chicago, 900 E. 57th. Street, Chicago, IL, 60637, USA.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Spring', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, 680 North Lakeshore Drive, Chicago, IL, 60611, USA.'}]",Clinical epigenetics,['10.1186/s13148-019-0707-0']
972,31263284,Supplementation with Akkermansia muciniphila in overweight and obese human volunteers: a proof-of-concept exploratory study.,"Metabolic syndrome is characterized by a constellation of comorbidities that predispose individuals to an increased risk of developing cardiovascular pathologies as well as type 2 diabetes mellitus 1 . The gut microbiota is a new key contributor involved in the onset of obesity-related disorders 2 . In humans, studies have provided evidence for a negative correlation between Akkermansia muciniphila abundance and overweight, obesity, untreated type 2 diabetes mellitus or hypertension 3-8 . Since the administration of A. muciniphila has never been investigated in humans, we conducted a randomized, double-blind, placebo-controlled pilot study in overweight/obese insulin-resistant volunteers; 40 were enrolled and 32 completed the trial. The primary end points were safety, tolerability and metabolic parameters (that is, insulin resistance, circulating lipids, visceral adiposity and body mass). Secondary outcomes were gut barrier function (that is, plasma lipopolysaccharides) and gut microbiota composition. In this single-center study, we demonstrated that daily oral supplementation of 10 10  A. muciniphila bacteria either live or pasteurized for three months was safe and well tolerated. Compared to placebo, pasteurized A. muciniphila improved insulin sensitivity (+28.62 ± 7.02%, P = 0.002), and reduced insulinemia (-34.08 ± 7.12%, P = 0.006) and plasma total cholesterol (-8.68 ± 2.38%, P = 0.02). Pasteurized A. muciniphila supplementation slightly decreased body weight (-2.27 ± 0.92 kg, P = 0.091) compared to the placebo group, and fat mass (-1.37 ± 0.82 kg, P = 0.092) and hip circumference (-2.63 ± 1.14 cm, P = 0.091) compared to baseline. After three months of supplementation, A. muciniphila reduced the levels of the relevant blood markers for liver dysfunction and inflammation while the overall gut microbiome structure was unaffected. In conclusion, this proof-of-concept study (clinical trial no. NCT02637115 ) shows that the intervention was safe and well tolerated and that supplementation with A. muciniphila improves several metabolic parameters.",2019,"Compared to placebo, pasteurized A. muciniphila improved insulin sensitivity (+28.62 ± 7.02%, P = 0.002), and reduced insulinemia (-34.08 ± 7.12%, P = 0.006) and plasma total cholesterol (-8.68 ± 2.38%, P = 0.02).","['overweight/obese insulin-resistant volunteers; 40 were enrolled and 32 completed the trial', 'overweight and obese human volunteers']","['placebo', 'Akkermansia muciniphila']","['safe and well tolerated', 'insulin sensitivity', 'reduced insulinemia', 'several metabolic parameters', 'body weight', 'fat mass', 'gut barrier function (that is, plasma lipopolysaccharides) and gut microbiota composition', 'hip circumference', 'safety, tolerability and metabolic parameters (that is, insulin resistance, circulating lipids, visceral adiposity and body mass', 'levels of the relevant blood markers for liver dysfunction and inflammation', 'plasma total cholesterol']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0020155', 'cui_str': 'Human Volunteers'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1490590', 'cui_str': 'Akkermansia muciniphila'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0023810', 'cui_str': 'Lipoglycans'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005768'}, {'cui': 'C0086565', 'cui_str': 'Liver Dysfunction'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]",40.0,0.293433,"Compared to placebo, pasteurized A. muciniphila improved insulin sensitivity (+28.62 ± 7.02%, P = 0.002), and reduced insulinemia (-34.08 ± 7.12%, P = 0.006) and plasma total cholesterol (-8.68 ± 2.38%, P = 0.02).","[{'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Depommier', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, WELBIO, Walloon Excellence in Life Sciences and BIOtechnology, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Amandine', 'Initials': 'A', 'LastName': 'Everard', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, WELBIO, Walloon Excellence in Life Sciences and BIOtechnology, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Druart', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, WELBIO, Walloon Excellence in Life Sciences and BIOtechnology, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Plovier', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, WELBIO, Walloon Excellence in Life Sciences and BIOtechnology, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Van Hul', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, WELBIO, Walloon Excellence in Life Sciences and BIOtechnology, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Vieira-Silva', 'Affiliation': 'Laboratory of Molecular Bacteriology-Department of Microbiology and Immunology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Gwen', 'Initials': 'G', 'LastName': 'Falony', 'Affiliation': 'Laboratory of Molecular Bacteriology-Department of Microbiology and Immunology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Raes', 'Affiliation': 'Laboratory of Molecular Bacteriology-Department of Microbiology and Immunology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Maiter', 'Affiliation': 'Pôle EDIN, Institut de Recherches Expérimentales et Cliniques, UCLouvain, Université catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Nathalie M', 'Initials': 'NM', 'LastName': 'Delzenne', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'de Barsy', 'Affiliation': 'Pôle EDIN, Institut de Recherches Expérimentales et Cliniques, UCLouvain, Université catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Loumaye', 'Affiliation': 'Pôle EDIN, Institut de Recherches Expérimentales et Cliniques, UCLouvain, Université catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Michel P', 'Initials': 'MP', 'LastName': 'Hermans', 'Affiliation': 'Pôle EDIN, Institut de Recherches Expérimentales et Cliniques, UCLouvain, Université catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Thissen', 'Affiliation': 'Pôle EDIN, Institut de Recherches Expérimentales et Cliniques, UCLouvain, Université catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Willem M', 'Initials': 'WM', 'LastName': 'de Vos', 'Affiliation': 'Laboratory of Microbiology, Wageningen University, Wageningen, the Netherlands.'}, {'ForeName': 'Patrice D', 'Initials': 'PD', 'LastName': 'Cani', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, WELBIO, Walloon Excellence in Life Sciences and BIOtechnology, UCLouvain, Université catholique de Louvain, Brussels, Belgium. Patrice.cani@uclouvain.be.'}]",Nature medicine,['10.1038/s41591-019-0495-2']
973,31643025,The Effects of a Health Care-Based Brief Intervention on Dating Abuse Perpetration: Results of a Randomized Controlled Trial.,"Dating abuse (DA) is prevalent and consequential, yet there are no evidence-based interventions for the health care setting that prevent perpetration. The current study's purpose was to test a one-session brief motivational interview-style intervention to decrease DA perpetration. We conducted a two-arm RCT of the Real Talk intervention with follow-up at 3 and 6 months. Participants were 172 youth ages 15-19 years old, recruited from the pediatric emergency department or outpatient care services of an urban hospital in the USA in 2014-2017. The primary outcome was change in self-reported DA perpetration, including subtypes of DA such as physical, sexual, psychological, and cyber DA. Youth in both intervention and control arms reduced DA perpetration over time. GEE models indicated no overall intervention effects for any, physical, sexual, or psychological DA. There were overall effects for cyber DA (RR 0.49, 95% CI 0.27, 0.87). There were also effects at 3 months for psychological DA (RR 0.24, 95% CI 0.06, 0.93) and cyber DA (RR 0.39, 95% CI 0.19, 0.79). Analyses stratified by gender also found overall effects for males for any DA (RR 0.20, 95% CI 0.07, 0.55), physical DA (RR 0.30, 95% CI 0.10, 0.89), and cyber DA (RR 0.04, 95% CI 0.01, 0.27). For males, intervention effects on any DA persisted to 6 months (RR 0.13, 95% CI 0.02, 1.01). This health care-based one-session DA intervention is a potentially promising approach to reduce DA perpetration among adolescents.Clinical trial registration: This study is registered at www.clinicaltrials.gov NCT02080923.",2020,"There were overall effects for cyber DA (RR 0.49, 95% CI 0.27, 0.87).","['Participants were 172 youth ages 15-19\xa0years old, recruited from the pediatric emergency department or outpatient care services of an urban hospital in the USA in 2014-2017', 'adolescents', 'Dating Abuse Perpetration']","['motivational interview-style intervention', 'Health Care-Based Brief Intervention']","['cyber DA', 'physical, sexual, or psychological DA', 'physical DA', 'change in self-reported DA perpetration, including subtypes of DA such as physical, sexual, psychological, and cyber DA']","[{'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0020029', 'cui_str': 'Hospitals, Metropolitan'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C1546935', 'cui_str': 'Abuse (event)'}]","[{'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}]",172.0,0.102872,"There were overall effects for cyber DA (RR 0.49, 95% CI 0.27, 0.87).","[{'ForeName': 'Emily F', 'Initials': 'EF', 'LastName': 'Rothman', 'Affiliation': 'Department of Community Health Sciences, Boston University School of Public Health, Floor 4, 801 Massachusetts Avenue, Boston, MA, 02118, USA. erothman@bu.edu.'}, {'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Stuart', 'Affiliation': 'University of Tennessee, Knoxville, TN, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Heeren', 'Affiliation': 'Department of Community Health Sciences, Boston University School of Public Health, Floor 4, 801 Massachusetts Avenue, Boston, MA, 02118, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Paruk', 'Affiliation': 'Department of Community Health Sciences, Boston University School of Public Health, Floor 4, 801 Massachusetts Avenue, Boston, MA, 02118, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Bair-Merritt', 'Affiliation': 'Boston University School of Medicine, Boston, MA, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-019-01054-w']
974,30649970,Enhancing Parenting Quality for Young Children Adopted Internationally: Results of a Randomized Controlled Trial.,"Children adopted internationally are often dysregulated biologically and behaviorally due to prior experiences of institutional care or caregiving changes and thus are in need of enhanced parental care. The present study assessed whether parents randomized to receive Attachment and Biobehavioral Catch-up (ABC) demonstrated significant improvements in parenting quality when compared to parents receiving a control intervention. Participants were 120 internationally adopted children and their adoptive parents. Sixty-three (52.5%) of the children and 113 (94.2%) of the primary caregivers were female. Children were adopted from several countries and predominantly from China, Russia, South Korea, and Ethiopia. The majority of parents identified themselves as White/non-Hispanic (95.0%). At the start of intervention, parents ranged in age from 26.2 to 51.1 years old ( M = 39.7,  SD  = 6.0), and children ranged in age from 6.8 months to 48.4 months ( M  = 21.9,  SD  = 9.0). Sensitivity (i.e., contingent responsiveness to a child's cues), intrusiveness (i.e., physical and/or verbal behavior that interferes with a child's autonomy), and positive regard (i.e., positive affect expressed towards a child) were assessed at preintervention, immediately postintervention, and at annual follow-up visits. Parents who received ABC showed better parenting quality at postintervention than parents who received a control intervention, and these effects persisted at a 2-year follow-up. Findings add to the growing evidence that ABC improves parenting abilities, extending findings to adoptive parents and demonstrating that improvements in parenting quality were sustained several years after completion of the intervention. Trial registration: ClinicalTrials.gov NCT00816621.",2020,"Parents who received ABC showed better parenting quality at postintervention than parents who received a control intervention, and these effects persisted at a 2-year follow-up.","['parents ranged in age from 26.2 to 51.1\xa0years old (M=\xa039.7, SD\xa0=\xa06.0), and children ranged in age from 6.8\xa0months to 48.4\xa0months (M =\xa021.9, SD\xa0=\xa09.0', 'Participants were 120 internationally adopted children and their adoptive parents', 'Young Children', 'Sixty-three (52.5%) of the children and 113 (94.2%) of the primary caregivers were female']","['ABC', 'Attachment and Biobehavioral Catch-up (ABC', 'control intervention']","['Enhancing Parenting Quality', 'parenting abilities', 'parenting quality', ""Sensitivity (i.e., contingent responsiveness to a child's cues), intrusiveness (i.e., physical and/or verbal behavior that interferes with a child's autonomy""]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0337541', 'cui_str': 'Adopted child (person)'}, {'cui': 'C0337466', 'cui_str': 'Adoptive parent (person)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C4517802', 'cui_str': '52.5 (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0231617', 'cui_str': 'Catch (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0042530', 'cui_str': 'Verbal Behavior'}, {'cui': 'C0521102', 'cui_str': 'Interferes with (contextual qualifier) (qualifier value)'}]",120.0,0.0406424,"Parents who received ABC showed better parenting quality at postintervention than parents who received a control intervention, and these effects persisted at a 2-year follow-up.","[{'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Yarger', 'Affiliation': 'Department of Psychology, University of Maryland.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Bernard', 'Affiliation': 'Department of Psychology, Stony Brook University.'}, {'ForeName': 'E B', 'Initials': 'EB', 'LastName': 'Caron', 'Affiliation': 'Department of Psychiatry, University of Connecticut Health Center.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Wallin', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Delaware.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Dozier', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Delaware.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2018.1547972']
975,31206056,Health costs and efficiencies of patient-specific and single-use instrumentation in total knee arthroplasty: a randomised controlled trial.,"Aim


To investigate whether patient-specific instrumentation (PSI) and single-use instrumentation (SUI) improve operating room efficiency in terms of time and cost to the healthcare provider over conventional/reusable instrumentation (CVR) when performing total knee arthroplasty (TKA).
Patients and methods


Patients requiring TKA were randomised into one of four surgical groups: CVR, CVS (conventional/SUI), PSR (PSI/reusable) and PSS (PSI/SUI). All surgical procedures were video recorded to determine specific surgical time intervals. Other variables reported included the number of instrument trays used, missing equipment, direct instrument costs and the weight of the instruments the staff had to handle. Oxford Knee Score (OKS), estimated blood loss and lengths of hospital stay were also recorded as markers of patient experience.
Results


PSR was significantly quicker in all the recorded time intervals, used less trays, experienced less missing equipment and resulted in lower blood loss and shorter hospital stays. SUI reported significantly slower operating room times and resulted in higher blood loss, but SUI was 88% lighter and 20% cheaper on average when compared with their reusable counterparts. Despite the economic advantages of PSI and SUI, the patients who reported greatest improvements in OKS were those allocated to the CVR group, but no clinically meaningful difference in OKS was found at any time point.
Conclusions


PSI and SUI for TKA have the potential of reducing operating room times over conventional, reusable sets. This reduction will benefit theatre personnel ergonomically, while presenting the healthcare provider with potential cost-saving benefits in terms of reduced sterilisation costs and surgical times.",2019,"Results


PSR was significantly quicker in all the recorded time intervals, used less trays, experienced less missing equipment and resulted in lower blood loss and shorter hospital stays.","['total knee arthroplasty', 'Patients and methods\n\n\nPatients requiring TKA']","['patient-specific and single-use instrumentation', 'CVR, CVS (conventional/SUI), PSR (PSI/reusable) and PSS (PSI/SUI', 'patient-specific instrumentation (PSI) and single-use instrumentation (SUI']","['higher blood loss', 'blood loss and shorter hospital stays', 'Oxford Knee Score (OKS), estimated blood loss and lengths of hospital stay', 'OKS']","[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1706489', 'cui_str': 'Psi'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score (observable entity)'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C1444754', 'cui_str': 'Length property'}]",,0.0370845,"Results


PSR was significantly quicker in all the recorded time intervals, used less trays, experienced less missing equipment and resulted in lower blood loss and shorter hospital stays.","[{'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Attard', 'Affiliation': 'Biomedical Engineering, University of Strathclyde, Glasgow, UK.'}, {'ForeName': 'Gwenllian Fflur', 'Initials': 'GF', 'LastName': 'Tawy', 'Affiliation': 'Division of Cell Matrix Biology and Regenerative Medicine, University of Manchester, Manchester, UK.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Simons', 'Affiliation': 'Clinical Surgery, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Riches', 'Affiliation': 'Biomedical Engineering, University of Strathclyde, Glasgow, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Rowe', 'Affiliation': 'Biomedical Engineering, University of Strathclyde, Glasgow, UK.'}, {'ForeName': 'Leela C', 'Initials': 'LC', 'LastName': 'Biant', 'Affiliation': 'Division of Cell Matrix Biology and Regenerative Medicine, University of Manchester, Manchester, UK.'}]",BMJ open quality,['10.1136/bmjoq-2018-000493']
976,30644627,Vaping characteristics and expectancies are associated with smoking cessation propensity among dual users of combustible and electronic cigarettes.,"BACKGROUND AND AIMS


Most e-cigarette users who also smoke combustible cigarettes (dual users) begin vaping to quit smoking, yet only a subset succeeds. We hypothesized that reinforcing characteristics of e-cigarettes (vaping reinforcement) would positively predict smoking cessation propensity (SCP) among dual users.
DESIGN


Secondary analysis of cross-sectional baseline data from dual users in an ongoing smoking cessation trial. Exploratory and confirmatory factor analysis (EFA and CFA) created latent variables for vaping reinforcement and SCP. A structural equation modeling (SEM) approach was used to test the hypothesis.
SETTING


United States.
PARTICIPANTS


A national sample of dual users of combustible and electronic cigarettes who smoke and vape at least once per week (n = 2896) were enrolled (63% male; mean age = 29.9 years) into a randomized controlled trial in which they would receive either smoking cessation materials or no smoking cessation materials.
MEASUREMENTS


Vaping reinforcement was indexed by vaping frequency (days/week vaping, times/day vaping, puffs/e-cigarette use), e-cigarette characteristics [numbers of modifications and tobacco or non-tobacco flavors, nicotine content (mg) and positive e-cigarette expectancies]. SCP was measured by items of confidence, commitment to being smoke-free, cessation motivation (contemplation ladder), change in cigarettes per day since beginning e-cigarette use and negative smoking expectancies.
FINDINGS


Four factors emerged from the EFA: vaping propensity (vaping frequency, positive expectancies), vaping enthusiasm (e-cigarette modifications, using non-tobacco flavors, puffs per use), nicotine/tobacco flavor (nicotine strength, tobacco flavors) and SCP (negative expectancies about smoking, motivation to quit smoking, reduction in smoking). A CFA upheld the exploratory factor structure [root mean square error of approximation (RMSEA) = 0.046, CFI = 0.91]. An SEM with the three vaping latent variables directly predicting SCP had good model fit (RMSEA = 0.030, CFI = 0.97) with a positive relationship of vaping propensity (0.509, P < 0.001), and small negative relationships of vaping enthusiasm (-0.158, P = 0.014) and nicotine/tobacco flavor (-0.230, P < 0.001).
CONCLUSIONS


Among e-cigarette users who also smoke combustible cigarettes, frequent vaping combined with positive e-cigarette expectancies appears to predict greater smoking cessation propensity. However, vaping enthusiasm (measured by e-cigarette modifications, using non-tobacco flavors and puffs per use), higher nicotine content and use of tobacco flavored solution may reduce cessation propensity.",2019,"A CFA upheld the exploratory factor structure [root mean square error of approximation (RMSEA) = 0.046, CFI = 0.91].","['Most e-cigarette users who also smoke combustible cigarettes (dual users', 'A national sample of dual users of combustible and electronic cigarettes who smoke and vape at least once per week (n\xa0=\xa02896) were enrolled (63% male; mean age\xa0=\xa029.9\xa0years', 'United States']",['smoking cessation materials or no smoking cessation materials'],"['e-cigarette characteristics [numbers of modifications and tobacco or non-tobacco flavors, nicotine content (mg) and positive e-cigarette expectancies', 'nicotine/tobacco flavor', 'SCP']","[{'cui': 'C4087159', 'cui_str': 'Electronic cigarette user (finding)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C4083280', 'cui_str': 'Vaping'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}]",2896.0,0.0374696,"A CFA upheld the exploratory factor structure [root mean square error of approximation (RMSEA) = 0.046, CFI = 0.91].","[{'ForeName': 'Karen O', 'Initials': 'KO', 'LastName': 'Brandon', 'Affiliation': 'Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Vani N', 'Initials': 'VN', 'LastName': 'Simmons', 'Affiliation': 'Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Meltzer', 'Affiliation': 'Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Drobes', 'Affiliation': 'Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Úrsula', 'Initials': 'Ú', 'LastName': 'Martínez', 'Affiliation': 'Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Sutton', 'Affiliation': 'Department of Psychology, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Palmer', 'Affiliation': 'Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Bullen', 'Affiliation': 'School of Population Health, Faculty of Medical and Health Science, University of Auckland, New Zealand.'}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Harrell', 'Affiliation': 'Department of Pediatrics, Eastern Virginia Medical School, Norfolk, VA, USA.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Brandon', 'Affiliation': 'Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center, Tampa, FL, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.14551']
977,30283029,"Double-blind, placebo-controlled, dose-ranging trial of intravenous ketamine as adjunctive therapy in treatment-resistant depression (TRD).","Numerous placebo-controlled studies have demonstrated the ability of ketamine, an NMDA receptor antagonist, to induce rapid (within hours), transient antidepressant effects when administered intravenously (IV) at subanesthetic doses (0.5 mg/kg over 40 min). However, the optimal antidepressant dose remains unknown. We aimed to compare to active placebo the rapid acting antidepressant properties of a broad range of subanesthetic doses of IV ketamine among outpatients with treatment-resistant depression (TRD). A range of IV ketamine doses were compared to active placebo in the treatment of adult TRD over a 3-day period following a single infusion over 40 min. This was an outpatient study conducted across six US academic sites. Outpatients were 18-70 years old with TRD, defined as failure to achieve a satisfactory response (e.g., less than 50% improvement of depression symptoms) to at least two adequate treatment courses during the current depressive episode. Following a washout period, 99 eligible subjects were randomly assigned to one of the five arms in a 1:1:1:1:1 fashion: a single intravenous dose of ketamine 0.1 mg/kg (n = 18), a single dose of ketamine 0.2 mg/kg (n = 20), a single dose of ketamine 0.5 mg/kg (n = 22), a single dose of ketamine 1.0 mg/kg (n = 20), and a single dose of midazolam 0.045 mg/kg (active placebo) (n = 19). The study assessments (HAM-D-6, MADRS, SDQ, PAS, CGI-S, and CGI-I) were performed at days 0, 1, 3 (endpoint), 5, 7, 14, and 30 to assess the safety and efficacy. The overall group × time interaction effect was significant for the primary outcome measure, the HAM-D-6. In post hoc pairwise comparisons controlling for multiple comparisons, standard dose (0.5 mg/kg) and high dose (1 mg/kg) of intravenous ketamine were superior to active placebo; a low dose (0.1 mg/kg) was significant only prior to adjustment (p = 0.02, p-adj = 0.14, d = -0.82 at day 1). Most of the interaction effect was due to differences at day 1, with no significant adjusted pairwise differences at day 3. This pattern generally held for secondary outcomes. The infusions of ketamine were relatively well tolerated compared to active placebo, except for greater dissociative symptoms and transient blood pressure elevations with the higher doses. Our results suggest that there is evidence for the efficacy of the 0.5 mg/kg and 1.0 mg/kg subanesthetic doses of IV ketamine and no clear or consistent evidence for clinically meaningful efficacy of lower doses of IV ketamine. Trial Registration: NCT01920555.",2020,"The infusions of ketamine were relatively well tolerated compared to active placebo, except for greater dissociative symptoms and transient blood pressure elevations with the higher doses.","['99 eligible subjects', 'Outpatients were 18-70 years old with TRD, defined as failure to achieve a satisfactory response (e.g., less than 50% improvement of depression symptoms) to at least two adequate treatment courses during the current depressive episode', 'treatment-resistant depression (TRD', 'outpatients with treatment-resistant depression (TRD']","['ketamine', 'IV ketamine', 'placebo', 'midazolam 0.045\u2009mg/kg (active placebo', 'ketamine 0.1\u2009mg/kg']","['safety and efficacy', 'HAM-D-6', 'dissociative symptoms and transient blood pressure elevations', 'study assessments (HAM-D-6, MADRS, SDQ, PAS, CGI-S, and CGI-I']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C4517410', 'cui_str': 'Zero point zero four five'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3853311', 'cui_str': 'Ham'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0497247', 'cui_str': 'Finding of increased blood pressure (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",99.0,0.456136,"The infusions of ketamine were relatively well tolerated compared to active placebo, except for greater dissociative symptoms and transient blood pressure elevations with the higher doses.","[{'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA. mfava@mgh.harvard.edu.'}, {'ForeName': 'Marlene P', 'Initials': 'MP', 'LastName': 'Freeman', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Flynn', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Judge', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Bettina B', 'Initials': 'BB', 'LastName': 'Hoeppner', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Cusin', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Dawn F', 'Initials': 'DF', 'LastName': 'Ionescu', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Sanjay J', 'Initials': 'SJ', 'LastName': 'Mathew', 'Affiliation': 'Baylor College of Medicine/Michael E. Debakey VA Medical Center, Houston, TX, USA.'}, {'ForeName': 'Lee C', 'Initials': 'LC', 'LastName': 'Chang', 'Affiliation': 'Baylor College of Medicine/Michael E. Debakey VA Medical Center, Houston, TX, USA.'}, {'ForeName': 'Dan V', 'Initials': 'DV', 'LastName': 'Iosifescu', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Murrough', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Debattista', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Alan F', 'Initials': 'AF', 'LastName': 'Schatzberg', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'University of Texas Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'University of Texas Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Sanacora', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'Samuel T', 'Initials': 'ST', 'LastName': 'Wilkinson', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'George I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}]",Molecular psychiatry,['10.1038/s41380-018-0256-5']
978,32060880,Preventing College Sexual Victimization by Reducing Hookups: a Randomized Controlled Trial of a Personalized Normative Feedback Intervention.,"Sexual activity, including hooking up, increases college women's vulnerability to sexual victimization. Reducing hookups may reduce rates of sexual victimization among this vulnerable population. Because college students overestimate how frequently their peers hook up, correcting their misperceptions may lead to more accurate perceived social norms, and consequently, less hookup behavior. The study was designed as a randomized controlled trial of the efficacy of a brief, computer-administered personalized normative feedback (PNF) intervention regarding hookups during the first semester of college. We tested an indirect effects model in which PNF was hypothesized to predict perceiving fewer peer hookups, which were expected to predict fewer actual hookups and consequently, less sexual victimization during the first semester of college. Entering first-year women (N = 760) were randomly assigned to receive web-delivered PNF or no information. At the end of the semester, perceived number of hookups of others, number of hookups during the semester, and sexual victimization experiences were assessed. Women who received the intervention perceived that their peers engaged in significantly fewer hookups than did control women. Consistent with the proposed indirect effects model, intervention had a significant indirect effect on the odds of first-semester victimization via lower perceived descriptive norms, which in turn predicted fewer hookups. The study provides proof of concept for the importance of hookups as a risk factor for sexual victimization and provides novel, preliminary support for intervention to change descriptive norms as a way of reducing hookups and consequently, sexual vulnerability.",2020,Women who received the intervention perceived that their peers engaged in significantly fewer hookups than did control women.,"['hookups during the first semester of college', 'Entering first-year women (N\u2009=\u2009760']","['PNF or no information', 'computer-administered personalized normative feedback (PNF) intervention', 'Personalized Normative Feedback Intervention']","['number of hookups of others, number of hookups during the semester, and sexual victimization experiences']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}]",760.0,0.0411,Women who received the intervention perceived that their peers engaged in significantly fewer hookups than did control women.,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Testa', 'Affiliation': 'Department of Psychology and Clinical and Research Institute on Addictions, University at Buffalo, Buffalo, USA. mltesta@buffalo.edu.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Livingston', 'Affiliation': 'School of Nursing, University at Buffalo, Buffalo, USA.'}, {'ForeName': 'Weijun', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Psychology and Clinical and Research Institute on Addictions, University at Buffalo, Buffalo, USA.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Lewis', 'Affiliation': 'Department of Health Behavior and Health Systems, School of Public Health, University of North Texas Health Science Center, Fort Worth, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01098-3']
979,31775859,Metronidazole versus lactic acid for treating bacterial vaginosis (VITA): protocol for a randomised controlled trial to assess the clinical and cost effectiveness of topical lactic acid gel for treating second and subsequent episodes of bacterial vaginosis.,"BACKGROUND


Bacterial vaginosis (BV) affects 30-50% of women at some time in their lives and is an embarrassing and distressing condition which can be associated with potentially serious comorbidities. Current antibiotic treatments such as metronidazole are effective but can result in side effects, and recurrence is common. This trial aims to investigate whether lactic acid gel is clinically effective and cost effective in the treatment of recurrent BV compared with metronidazole.
METHODS


VITA is an open-label, multicentre, parallel group randomised controlled trial for women with a clinical diagnosis of BV and at least one previous BV episode in the past 2 years. Participants will be randomised 1:1 to intravaginal lactic acid gel 5 ml once daily for 7 days or oral metronidazole tablets 400 mg twice daily for 7 days. All participants will be followed up for 6 months to assess health status and healthcare costs. A subgroup will be interviewed to further explore adherence, tolerability and acceptability of treatment. The estimated sample size is 1900 participants to detect a 6% absolute increase in response rate to 86% in those receiving lactic acid gel. The primary outcome is participant-reported resolution of BV at Week 2.
DISCUSSION


Results from this trial will help inform UK treatment guidelines for BV and may provide an alternative effective treatment for recurrent episodes of this condition which avoids repeated exposure to antibiotics.
TRIAL REGISTRATION


ISRCTN, ISRCTN14161293. Registered on 8 September 2017.",2019,"This trial aims to investigate whether lactic acid gel is clinically effective and cost effective in the treatment of recurrent BV compared with metronidazole.
",['women with a clinical diagnosis of BV and at least one previous BV episode in the past 2\u2009years'],"['metronidazole tablets', 'lactic acid gel', 'topical lactic acid gel', 'metronidazole', 'intravaginal lactic acid gel', 'Metronidazole versus lactic acid']","['response rate', 'participant-reported resolution of BV at Week 2', 'health status and healthcare costs']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0064582', 'cui_str': 'Lactic acid'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0442122', 'cui_str': 'Intravaginal (qualifier value)'}]","[{'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}]",1900.0,0.275661,"This trial aims to investigate whether lactic acid gel is clinically effective and cost effective in the treatment of recurrent BV compared with metronidazole.
","[{'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Armstrong-Buisseret', 'Affiliation': 'Nottingham Clinical Trials Unit (NCTU), Building 42, University of Nottingham, University Park, Nottingham, NG7 2RD, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Brittain', 'Affiliation': 'Nottingham Clinical Trials Unit (NCTU), Building 42, University of Nottingham, University Park, Nottingham, NG7 2RD, UK.'}, {'ForeName': 'Miruna', 'Initials': 'M', 'LastName': 'David', 'Affiliation': 'Clinical Microbiology, University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital Birmingham, Mindelsohn Way, Edgbaston, Birmingham, B15 2GW, UK.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Dean', 'Affiliation': 'Elton John Research Centre, Sussex House, 1 Abbey Road, Brighton, BN2 1ES, UK.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Griffiths', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Trish', 'Initials': 'T', 'LastName': 'Hepburn', 'Affiliation': 'Nottingham Clinical Trials Unit (NCTU), Building 42, University of Nottingham, University Park, Nottingham, NG7 2RD, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Jackson', 'Affiliation': 'Health Economics Unit, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Kai', 'Affiliation': 'School of Medicine, Tower Building, University of Nottingham, University Park, Nottingham, NG7 2RD, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Montgomery', 'Affiliation': 'Nottingham Clinical Trials Unit (NCTU), Building 42, University of Nottingham, University Park, Nottingham, NG7 2RD, UK.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Roberts', 'Affiliation': 'Health Economics Unit, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Sukhwinder', 'Initials': 'S', 'LastName': 'Thandi', 'Affiliation': 'Nottingham Clinical Trials Unit (NCTU), Building 42, University of Nottingham, University Park, Nottingham, NG7 2RD, UK.'}, {'ForeName': 'Jonathan D C', 'Initials': 'JDC', 'LastName': 'Ross', 'Affiliation': 'Department of GU Medicine, University Hospitals Birmingham NHS Foundation Trust, Whittall Street Clinic, Whittall Street, Birmingham, B4 6DH, UK. jonathan.ross@uhb.nhs.uk.'}]",Trials,['10.1186/s13063-019-3731-7']
980,32146127,Molecular lymph node staging for bladder cancer patients undergoing radical cystectomy with pelvic lymph node dissection.,"OBJECTIVE


Presence of lymph node (LN) metastasis in bladder cancer (BCa) is a main risk factor for tumor recurrence after radical cystectomy (RC). Molecular analysis facilitates detection of small-volume LN metastases with higher sensitivity than standard histopathology. The aim of the present study was to establish molecular LN analysis in BCa patients undergoing RC with lymph node dissection (LND) and to determine its ability to predict tumor recurrence.
PATIENTS AND METHODS


Five transcripts with overexpression in BCa (FXYD3, KRT17, KRT20, SPINK1, UPKII) were evaluated for molecular LN analysis. We included 76 BCa patients from the prospective, randomized surgical phase-III trial (LEA AUO AB 25/02, NCT01215071) investigating extended vs. limited LND at RC. The primary endpoint was recurrence-free survival (RFS). As control, 136 LNs from 45 patients without BCa were analyzed to determine a threshold for pathologic gene expression.
RESULTS


About 1,319 LNs were investigated with molecular and histopathologic examination. Histopathology detected 39 LN metastases in 17 (22%) patients. Of the tested genes FXYD3 performed best and classified all pN+-patients correctly as node-positive (pN+/molN+). In addition, FXYD3 reclassified 43 histopathologic negative LNs and 7 (9%) pN0-patients as molecular node-positive (pN0/molN+). Molecular and histopathologic LN status (pN0/molN0 vs. pN0/molN+ vs. pN+/molN+) was significantly associated with locally advanced disease (P = 0.006) and poor RFS (P < 0.001). Median RFS was not reached in LN-negative patients (pN0/molN0), 45 months (95%CI 8-83) in exclusively molecular positive patients (pN0/molN+) and 9 months (95%CI 5-13) in patients with histopathologic and molecular positive LNs (pN+/molN+).
CONCLUSIONS


Molecular LN analysis with FXYD3 identified additional LN metastases in histopathologic negative LNs and identified patients with elevated risk of tumor recurrence after RC. Thus, molecular LN analysis improves LN staging and might serve as a tool to guide adjuvant treatment.",2020,Of the tested genes FXYD3 performed best and classified all pN+-patients correctly as node-positive (pN+/molN+).,"['45 patients without BCa', '76 BCa patients', 'BCa patients undergoing RC with lymph node dissection (LND', 'bladder cancer patients undergoing radical cystectomy with pelvic lymph node dissection', 'bladder cancer (BCa']","['pN0/molN+ vs. pN+/molN', 'radical cystectomy (RC']","['Median RFS', 'locally advanced disease', 'recurrence-free survival (RFS', 'poor RFS', 'Molecular and histopathologic LN status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242382', 'cui_str': 'Lymph Node Dissection'}, {'cui': 'C0005684', 'cui_str': 'Malignant Tumor of Urinary Bladder'}, {'cui': 'C0194401', 'cui_str': 'Total resection of urinary bladder (procedure)'}, {'cui': 'C0729595', 'cui_str': 'Pelvic lymph node structure (body structure)'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}]","[{'cui': 'C0194401', 'cui_str': 'Total resection of urinary bladder (procedure)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",76.0,0.129531,Of the tested genes FXYD3 performed best and classified all pN+-patients correctly as node-positive (pN+/molN+).,"[{'ForeName': 'Matthias M', 'Initials': 'MM', 'LastName': 'Heck', 'Affiliation': 'Technical University of Munich, School of Medicine, Rechts der Isar Medical Center, Department of Urology, Munich, Germany. Electronic address: Matthias.Heck@tum.de.'}, {'ForeName': 'Florestan J', 'Initials': 'FJ', 'LastName': 'Koll', 'Affiliation': 'Technical University of Munich, School of Medicine, Rechts der Isar Medical Center, Department of Urology, Munich, Germany.'}, {'ForeName': 'Margitta', 'Initials': 'M', 'LastName': 'Retz', 'Affiliation': 'Technical University of Munich, School of Medicine, Rechts der Isar Medical Center, Department of Urology, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Autenrieth', 'Affiliation': 'Technical University of Munich, School of Medicine, Rechts der Isar Medical Center, Department of Urology, Munich, Germany.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Magg', 'Affiliation': 'Technical University of Munich, School of Medicine, Rechts der Isar Medical Center, Department of Urology, Munich, Germany.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Lunger', 'Affiliation': 'Technical University of Munich, School of Medicine, Rechts der Isar Medical Center, Department of Urology, Munich, Germany.'}, {'ForeName': 'Jürgen E', 'Initials': 'JE', 'LastName': 'Gschwend', 'Affiliation': 'Technical University of Munich, School of Medicine, Rechts der Isar Medical Center, Department of Urology, Munich, Germany.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Nawroth', 'Affiliation': 'Technical University of Munich, School of Medicine, Rechts der Isar Medical Center, Department of Urology, Munich, Germany.'}]",Urologic oncology,['10.1016/j.urolonc.2020.01.018']
981,30107974,Pilot Study of the Effects of High-Protein Meals During Hemodialysis on Intradialytic Hypotension in Patients Undergoing Maintenance Hemodialysis.,"OBJECTIVE


Patients undergoing hemodialysis (HD) have high protein and energy requirements, and protein-energy wasting is common and associated with poor outcomes. Eating during dialysis may improve nutritional status by counteracting the catabolic effects of HD treatment; but eating during HD may be discouraged because of concerns of postprandial hypotension. However, little data are available to support this practice. In this study, we hypothesized that high-protein meals during HD do not lead to symptomatic intradialytic hypotension events.
DESIGN


A 9-week, nonrandomized, parallel-arm study.
SETTING


A single in-center HD clinic.
SUBJECTS


Eighteen patients undergoing HD from 2 shifts completed the study. Patients were aged 62 ± 16 years with dialysis vintage of 3.4 ± 2.6 years.
INTERVENTION


Patients in the intervention group (n = 9) undergoing HD received meals of ∼30 g protein and ∼1/3 daily recommended intakes of sodium, potassium, phosphorus, and fluid during dialysis for 25 consecutive HD sessions. The control group (n = 9) completed all aspects of the study including a visit by study personnel but were not given meals. The 25 consecutive sessions before the start of the intervention/control phase were used as a baseline comparison for each patient.
MAIN OUTCOME MEASURE


Symptomatic hypotension event frequency.
RESULTS


In the intervention arm, there were 19 symptomatic hypotension events in 5 patients prestudy and 18 events in 6 patients during the study. In the control arm, there were 16 events in 7 patients prestudy and 13 events in 7 patients during the study. Change in the frequency of symptomatic hypotension events from prestudy to during study was not different between groups (P = .71). There was no effect of meals on nutritional status, but patients reported positive attitudes toward receiving meals during dialysis.
CONCLUSION


High-protein meals during HD did not increase symptomatic hypotension events. Larger, longer term studies are needed to confirm these results and evaluate whether high-protein meals on dialysis benefit nutritional status and clinical outcomes.",2019,Change in the frequency of symptomatic hypotension events from prestudy to during study was not different between groups (P = .71).,"['A single in-center HD clinic', 'Patients Undergoing Maintenance Hemodialysis', 'Eighteen patients undergoing HD from 2 shifts completed the study', 'Patients were aged 62\xa0±\xa016 years with dialysis vintage of 3.4\xa0±\xa02.6\xa0years', 'Patients undergoing hemodialysis (HD']","['HD received meals of ∼30 g protein and ∼1/3 daily recommended intakes of sodium, potassium, phosphorus, and fluid during dialysis', 'High-Protein Meals']","['symptomatic hypotension events', 'Intradialytic Hypotension', 'frequency of symptomatic hypotension events']","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C4517692', 'cui_str': '3.4 (qualifier value)'}, {'cui': 'C4517633', 'cui_str': 'Two point six'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0530867', 'cui_str': 'G13 Protein'}, {'cui': 'C3658259', 'cui_str': 'Recommended Daily Intake'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",18.0,0.0125428,Change in the frequency of symptomatic hypotension events from prestudy to during study was not different between groups (P = .71).,"[{'ForeName': 'Mun Sun', 'Initials': 'MS', 'LastName': 'Choi', 'Affiliation': 'Department of Nutrition Science, Purdue University, West Lafayette, Indiana.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Kistler', 'Affiliation': 'Department of Nutrition and Health Science, Ball State University, Muncie, Indiana.'}, {'ForeName': 'Gretchen N', 'Initials': 'GN', 'LastName': 'Wiese', 'Affiliation': 'Department of Nutrition Science, Purdue University, West Lafayette, Indiana.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Stremke', 'Affiliation': 'Department of Nutrition Science, Purdue University, West Lafayette, Indiana.'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Wright', 'Affiliation': 'Indiana Clinical and Translational Science Institute, Department of Nutrition Science, Purdue University, West Lafayette, Indiana.'}, {'ForeName': 'Ranjani N', 'Initials': 'RN', 'LastName': 'Moorthi', 'Affiliation': 'Department of Medicine/Division of Nephrology, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Moe', 'Affiliation': 'Department of Medicine/Division of Nephrology, Indiana University School of Medicine, Indianapolis, Indiana; Roudebush Veterans Administration Medical Center, Indianapolis, Indiana.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Hill Gallant', 'Affiliation': 'Department of Nutrition Science, Purdue University, West Lafayette, Indiana; Department of Medicine/Division of Nephrology, Indiana University School of Medicine, Indianapolis, Indiana. Electronic address: hillgallant@purdue.edu.'}]",Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation,['10.1053/j.jrn.2018.06.002']
982,31242924,Prospective target assessment and multimodal prediction of survival for personalized and risk-adapted treatment strategies in multiple myeloma in the GMMG-MM5 multicenter trial.,"BACKGROUND


Personalized and risk-adapted treatment strategies in multiple myeloma prerequisite feasibility of prospective assessment, reporting of targets, and prediction of survival probability in clinical routine. Our aim was first to set up and prospectively test our experimental and analysis strategy to perform advanced molecular diagnostics, i.e., interphase fluorescence in-situ hybridization (iFISH) in ≥ 90% and gene expression profiling (GEP) in ≥ 80% of patients within the first cycle of induction chemotherapy in a phase III trial, seen as prerequisite for target expression-based personalized treatment strategies. Secondly, whether the assessment of risk based on the integration of clinical, cytogenetic, and expression-based parameters (""metascoring"") is possible in this setting and superior to the use of single prognostic factors.
METHODS


We prospectively performed plasma cell purification, GEP using DNA-microarrays, and iFISH within our randomized multicenter GMMG-MM5-trial recruiting 604 patients between July 2010 and November 2013. Patient data were analyzed using our published gene expression report (GEP-R): after quality and identity control, integrated risk assessment (HM metascore) and targets were reported in clinical routine as pdf-document.
RESULTS


Bone marrow aspirates were obtained from 573/604 patients (95%) and could be CD138-purified in 559/573 (97.6%). Of these, iFISH-analysis was possible in 556 (99.5%), GEP in 458 (82%). Identity control using predictors for sex, light and heavy chain type allowed the exclusion of potential sample interchanges (none occurred). All samples passed quality control. As exemplary targets, IGF1R-expression was reported expressed in 33.1%, AURKA in 43.2% of patients. Risk stratification using an integrated approach, i.e., HM metascore, delineated 10/77/13% of patients as high/medium/low risk, transmitting into significantly different median progression-free survival (PFS) of 15 vs. 39 months vs. not reached (NR; P < 0.001) and median overall survival (OS) of 41 months vs. NR vs. NR (P < 0.001). Five-year PFS and OS-rates were 5/31/54% and 25/68/98%, respectively. Survival prediction by HM metascore (Brier score 0.132, P < 0.001) is superior compared with the current gold standard, i.e., revised ISS score (0.137, P = 0.005).
CONCLUSIONS


Prospective assessment and reporting of targets and risk by GEP-R in clinical routine are feasible in ≥ 80% of patients within the first cycle of induction chemotherapy, simultaneously allowing superior survival prediction.",2019,"Survival prediction by HM metascore (Brier score 0.132, P < 0.001) is superior compared with the current gold standard, i.e., revised ISS score (0.137, P = 0.005).
",['604 patients between July 2010 and November 2013'],[],"['revised ISS score', 'IGF1R-expression', 'median overall survival', 'OS-rates', 'Survival prediction by HM metascore', 'median progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0021504', 'cui_str': 'ISS Score'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",604.0,0.0599693,"Survival prediction by HM metascore (Brier score 0.132, P < 0.001) is superior compared with the current gold standard, i.e., revised ISS score (0.137, P = 0.005).
","[{'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Hose', 'Affiliation': 'Labor für Myelomforschung, Universitätsklinikum Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Beck', 'Affiliation': 'Labor für Myelomforschung, Universitätsklinikum Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Salwender', 'Affiliation': 'Department of Internal Medicine II, Asklepios Klinik Altona, Hamburg, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Emde', 'Affiliation': 'Labor für Myelomforschung, Universitätsklinikum Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Uta', 'Initials': 'U', 'LastName': 'Bertsch', 'Affiliation': 'Medizinische Klinik V, Universitätsklinikum Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Kunz', 'Affiliation': 'Deutsches Krebsforschungszentrum, Abteilung für Biostatistik, Heidelberg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Scheid', 'Affiliation': 'Department I of Internal Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Hänel', 'Affiliation': 'Department of Internal Medicine III, Klinikum Chemnitz GmbH, Chemnitz, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Weisel', 'Affiliation': 'Department of Hematology, Oncology and Immunology, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hielscher', 'Affiliation': 'Deutsches Krebsforschungszentrum, Abteilung für Biostatistik, Heidelberg, Germany.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Raab', 'Affiliation': 'Medizinische Klinik V, Universitätsklinikum Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Goldschmidt', 'Affiliation': 'Medizinische Klinik V, Universitätsklinikum Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Jauch', 'Affiliation': 'Universität Heidelberg, Institut für Humangenetik, Heidelberg, Germany.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Moreaux', 'Affiliation': 'IGH, CNRS, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Seckinger', 'Affiliation': 'Labor für Myelomforschung, Universitätsklinikum Heidelberg, Heidelberg, Germany. anja.seckinger@med.uni-heidelberg.de.'}]",Journal of hematology & oncology,['10.1186/s13045-019-0750-5']
983,30863852,Healthcare Costs and Life-years Gained From Treatments Within the Advancing Cryptococcal Meningitis Treatment for Africa (ACTA) Trial on Cryptococcal Meningitis: A Comparison of Antifungal Induction Strategies in Sub-Saharan Africa.,"BACKGROUND


Mortality from cryptoccocal meningitis remains high. The ACTA trial demonstrated that, compared with 2 weeks of amphotericin B (AmB) plus flucystosine (5FC), 1 week of AmB and 5FC was associated with lower mortality and 2 weeks of oral flucanozole (FLU) plus 5FC was non-inferior. Here, we assess the cost-effectiveness of these different treatment courses.
METHODS


Participants were randomized in a ratio of 2:1:1:1:1 to 2 weeks of oral 5FC and FLU, 1 week of AmB and FLU, 1 week of AmB and 5FC, 2 weeks of AmB and FLU, or 2 weeks of AmB and 5FC in Malawi, Zambia, Cameroon, and Tanzania. Data on individual resource use and health outcomes were collected. Cost-effectiveness was measured as incremental costs per life-year saved, and non-parametric bootstrapping was done.
RESULTS


Total costs per patient were US $1442 for 2 weeks of oral FLU and 5FC, $1763 for 1 week of AmB and FLU, $1861 for 1 week of AmB and 5FC, $2125 for 2 weeks of AmB and FLU, and $2285 for 2 weeks of AmB and 5FC. Compared to 2 weeks of AmB and 5FC, 1 week of AmB and 5FC was less costly and more effective and 2 weeks of oral FLU and 5FC was less costly and as effective. The incremental cost-effectiveness ratio for 1 week of AmB and 5FC versus oral FLU and 5FC was US $208 (95% confidence interval $91-1210) per life-year saved.
CLINICAL TRIALS REGISTRATION


ISRCTN45035509.
CONCLUSIONS


Both 1 week of AmB and 5FC and 2 weeks of Oral FLU and 5FC are cost-effective treatments.",2019,"Compared to 2 weeks of AmB and 5FC, 1 week of AmB and 5FC was less costly and more effective and 2 weeks of oral FLU and 5FC was less costly and as effective.","['Africa (ACTA) Trial on Cryptococcal Meningitis', 'Sub-Saharan Africa', 'Participants']","['oral 5FC and FLU, 1 week of AmB and FLU, 1 week of AmB and 5FC, 2 weeks of AmB and FLU, or 2 weeks of AmB and 5FC in Malawi, Zambia, Cameroon, and Tanzania', 'AmB and 5FC versus oral FLU and 5FC', 'oral flucanozole (FLU) plus 5FC', 'amphotericin B (AmB) plus flucystosine (5FC']","['Healthcare Costs and Life-years', 'Cost-effectiveness', 'incremental cost-effectiveness ratio', 'cost-effectiveness']","[{'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0085436', 'cui_str': 'Meningitis, Cryptococcal'}, {'cui': 'C0001738', 'cui_str': 'Subsaharan Africa'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0043445', 'cui_str': 'Republic of Zambia'}, {'cui': 'C0006802', 'cui_str': 'Republic of Cameron'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0002679', 'cui_str': 'Amphotericin B'}]","[{'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0297931,"Compared to 2 weeks of AmB and 5FC, 1 week of AmB and 5FC was less costly and more effective and 2 weeks of oral FLU and 5FC was less costly and as effective.","[{'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Liverpool School of Tropical Medicine, United Kingdom.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Mwenge', 'Affiliation': 'Zambart, Health Economics Unit, Lusaka Apex Medical University, Zambia.'}, {'ForeName': 'Shabir', 'Initials': 'S', 'LastName': 'Lakhi', 'Affiliation': 'University Teaching Hospital, Lusaka Apex Medical University, Zambia.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Chanda', 'Affiliation': 'Institute for Medical Research and Training, University Teaching Hospital, Lusaka Apex Medical University, Zambia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Mwaba', 'Affiliation': 'Department of Internal Medicine and Directorate of Research and Post-Graduate Studies, Lusaka Apex Medical University, Zambia.'}, {'ForeName': 'Síle F', 'Initials': 'SF', 'LastName': 'Molloy', 'Affiliation': ""Centre for Global Health, Institute for Infection and Immunity, St George's University of London, United Kingdom.""}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Gheorghe', 'Affiliation': 'London School of Hygiene and Tropical Medicine, United Kingdom.'}, {'ForeName': 'Ulla K', 'Initials': 'UK', 'LastName': 'Griffiths', 'Affiliation': 'London School of Hygiene and Tropical Medicine, United Kingdom.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Heyderman', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Kanyama', 'Affiliation': 'University of North Carolina Project-Malawi, Kamuzu Central Hospital, Lilongwe.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Kouanfack', 'Affiliation': 'Hôpital Central Yaoundé/Site Agence Nationale de Recherche sur le Sida Cameroun, Yaoundé Hopitaux de Paris, France.'}, {'ForeName': 'Sayoki', 'Initials': 'S', 'LastName': 'Mfinanga', 'Affiliation': 'Liverpool School of Tropical Medicine, United Kingdom.'}, {'ForeName': 'Adrienne K', 'Initials': 'AK', 'LastName': 'Chan', 'Affiliation': 'Dignitas International, Zomba Central Hospital, Malawi.'}, {'ForeName': 'Elvis', 'Initials': 'E', 'LastName': 'Temfack', 'Affiliation': 'Douala General Hospital, Cameroon.'}, {'ForeName': 'Sokoine', 'Initials': 'S', 'LastName': 'Kivuyo', 'Affiliation': 'National Institute for Medical Research, Muhimbili Medical Research Centre, Dar Es Salaam, United Republic of Tanzania.'}, {'ForeName': 'Mina C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': 'University of North Carolina Project-Malawi, Kamuzu Central Hospital, Lilongwe.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Lortholary', 'Affiliation': 'Institut Pasteur, Molecular Mycology Unit, Paris, France.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Loyse', 'Affiliation': ""Centre for Global Health, Institute for Infection and Immunity, St George's University of London, United Kingdom.""}, {'ForeName': 'Shabbar', 'Initials': 'S', 'LastName': 'Jaffar', 'Affiliation': 'Liverpool School of Tropical Medicine, United Kingdom.'}, {'ForeName': 'Thomas S', 'Initials': 'TS', 'LastName': 'Harrison', 'Affiliation': ""Centre for Global Health, Institute for Infection and Immunity, St George's University of London, United Kingdom.""}, {'ForeName': 'Louis W', 'Initials': 'LW', 'LastName': 'Niessen', 'Affiliation': 'Liverpool School of Tropical Medicine, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy971']
984,30701596,Understanding adolescent and parent acceptability and feasibility experience in a large Type 1 diabetes mellitus behavioural trial.,"AIMS


Using an 18-month, multisite randomized control trial as an exemplar, the aim of this study was to identify themes related to adolescent and parental feasibility and acceptability for participation in large behavioural trials designed to improve adolescents' Type 1 diabetes self-management.
METHODS


Thematic analysis methodology was used to develop themes describing factors related to acceptability and feasibility.
RESULTS


Based on a sample of interviews (N = 72), factors contributing to intervention acceptability and feasibility were identified. Aspects of acceptability included: a framework for goal-setting, the coach as a non-judgemental listener, perception of an ongoing benefit to participation and the delivery mode. Aspects of feasibility included: participants' altruism to help adolescents with Type 1 diabetes; pre-enrolment preparation for intervention content and duration; and the option of remote intervention delivery via telephone or video, which minimized travel time and costs. In addition, participants described positive outcomes including improvements in behaviour, Type 1 diabetes self-management behaviours and parent-adolescent communication, and emotion-attitude changes. Participants also described potential revisions that may inform future trials.
CONCLUSIONS


Acceptability and feasibility of behavioural interventions with adolescents with chronic illness have multifactorial dimensions. While empowering adolescent self-management, parental support is also an under-appreciated aspect to consider. Potential revisions were identified for subsequent behavioural trials.",2020,"In addition, participants described positive outcomes including improvements in behaviour, Type 1 diabetes self-management behaviours and parent-adolescent communication, and emotion-attitude changes.","[""adolescents' Type 1 diabetes self-management"", "" participants' altruism to help adolescents with Type 1 diabetes"", 'adolescents with chronic illness']",['behavioural interventions'],"['behaviour, Type 1 diabetes self-management behaviours and parent-adolescent communication, and emotion-attitude changes']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0002357', 'cui_str': 'Altruism'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}]",[],"[{'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0235187', 'cui_str': 'Attitude changed'}]",,0.0565679,"In addition, participants described positive outcomes including improvements in behaviour, Type 1 diabetes self-management behaviours and parent-adolescent communication, and emotion-attitude changes.","[{'ForeName': 'D H', 'Initials': 'DH', 'LastName': 'Grossoehme', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Smith', 'Affiliation': ""Divisions of Endocrinology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Standiford', 'Affiliation': ""Divisions of Endocrinology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Morwessel', 'Affiliation': ""Divisions of Endocrinology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kichler', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Maahs', 'Affiliation': 'Division of Pediatric Endocrinology, Stanford University, Stanford, CA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Driscoll', 'Affiliation': ""Department of Pediatrics, Barbara Davis Center for Childhood Diabetes, The Children's Hospital of Colorado, Aurora, CO.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Seid', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.13913']
985,31974286,"Sodium Bicarbonate Supplementation and Urinary TGF- β 1 in Nonacidotic Diabetic Kidney Disease: A Randomized, Controlled Trial.","BACKGROUND AND OBJECTIVES


In early-phase studies of individuals with hypertensive CKD and normal serum total CO 2 , sodium bicarbonate reduced urinary TGF- β 1 levels and preserved kidney function. The effect of sodium bicarbonate on kidney fibrosis and injury markers in individuals with diabetic kidney disease and normal serum total CO 2  is unknown.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


We conducted a randomized, double-blinded, placebo-controlled study in 74 United States veterans with type 1 or 2 diabetes mellitus, eGFR of 15-89 ml/min per 1.73 m 2 , urinary albumin-to-creatinine ratio (UACR) ≥30 mg/g, and serum total CO 2  of 22-28 meq/L. Participants received oral sodium bicarbonate (0.5 meq/kg lean body wt per day;  n =35) or placebo ( n =39) for 6 months. The primary outcome was change in urinary TGF- β 1-to-creatinine from baseline to months 3 and 6. Secondary outcomes included changes in urinary kidney injury molecule-1 (KIM-1)-to-creatinine, fibronectin-to-creatinine, neutrophil gelatinase-associated lipocalin (NGAL)-to-creatinine, and UACR from baseline to months 3 and 6.
RESULTS


Key baseline characteristics were age 72±8 years, eGFR of 51±18 ml/min per 1.73 m 2 , and serum total CO 2  of 24±2 meq/L. Sodium bicarbonate treatment increased mean total CO 2  by 1.2 (95% confidence interval [95% CI], 0.3 to 2.1) meq/L, increased urinary pH by 0.6 (95% CI, 0.5 to 0.8), and decreased urinary ammonium excretion by 5 (95% CI, 0 to 11) meq/d and urinary titratable acid excretion by 11 (95% CI, 5 to 18) meq/d. Sodium bicarbonate did not significantly change urinary TGF- β 1/creatinine (difference in change, 13%, 95% CI, -10% to 40%; change within the sodium bicarbonate group, 8%, 95% CI, -10% to 28%; change within the placebo group, -4%, 95% CI, -19% to 13%). Similarly, no significant effect on KIM-1-to-creatinine (difference in change, -10%, 95% CI, -38% to 31%), fibronectin-to-creatinine (8%, 95% CI, -15% to 37%), NGAL-to-creatinine (-33%, 95% CI, -56% to 4%), or UACR (1%, 95% CI, -25% to 36%) was observed.
CONCLUSIONS


In nonacidotic diabetic kidney disease, sodium bicarbonate did not significantly reduce urinary TGF- β 1, KIM-1, fibronectin, NGAL, or UACR over 6 months.",2020,Sodium bicarbonate did not significantly change urinary,"['74 United States veterans with type 1 or 2 diabetes mellitus, eGFR of 15-89 ml/min per 1.73 m 2 , urinary albumin-to-creatinine ratio (UACR) ≥30', 'individuals with hypertensive CKD and normal serum total CO 2 ', 'Nonacidotic Diabetic Kidney Disease', 'individuals with diabetic kidney disease and normal serum total CO 2']","['sodium bicarbonate', 'Sodium Bicarbonate Supplementation and Urinary TGF', 'oral sodium bicarbonate', 'placebo', 'Sodium bicarbonate', 'TGF']","['urinary pH', 'fibronectin-to-creatinine', 'urinary ammonium excretion', 'KIM-1-to-creatinine', 'NGAL-to-creatinine', 'change urinary', 'urinary titratable acid excretion', 'UACR', 'kidney fibrosis and injury markers', 'changes in urinary kidney injury molecule-1 (KIM-1)-to-creatinine, fibronectin-to-creatinine, neutrophil gelatinase-associated lipocalin (NGAL)-to-creatinine, and UACR', 'urinary TGF- β 1, KIM-1, fibronectin, NGAL, or UACR', 'mean total CO 2', 'change in urinary TGF- β 1-to-creatinine']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0011881', 'cui_str': 'Diabetic Nephropathy'}]","[{'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0016055', 'cui_str': 'Opsonic alpha(2)SB Glycoprotein'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0002611', 'cui_str': 'Ammonium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0151650', 'cui_str': 'Renal fibrosis (disorder)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2681921', 'cui_str': 'Kidney injury molecule-1'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0206528', 'cui_str': 'Gelatinases'}, {'cui': 'C1956074', 'cui_str': 'Lipocalins'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.452047,Sodium bicarbonate did not significantly change urinary,"[{'ForeName': 'Kalani L', 'Initials': 'KL', 'LastName': 'Raphael', 'Affiliation': 'Medicine Section, Veterans Affairs Salt Lake City Health Care System, Salt Lake City, Utah; and kalani.raphael@hsc.utah.edu.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Greene', 'Affiliation': 'Department of Internal Medicine, University of Utah Health, Salt Lake City, Utah.'}, {'ForeName': 'Guo', 'Initials': 'G', 'LastName': 'Wei', 'Affiliation': 'Department of Internal Medicine, University of Utah Health, Salt Lake City, Utah.'}, {'ForeName': 'Tristin', 'Initials': 'T', 'LastName': 'Bullshoe', 'Affiliation': 'Department of Internal Medicine, University of Utah Health, Salt Lake City, Utah.'}, {'ForeName': 'Kunani', 'Initials': 'K', 'LastName': 'Tuttle', 'Affiliation': 'Department of Internal Medicine, University of Utah Health, Salt Lake City, Utah.'}, {'ForeName': 'Alfred K', 'Initials': 'AK', 'LastName': 'Cheung', 'Affiliation': 'Medicine Section, Veterans Affairs Salt Lake City Health Care System, Salt Lake City, Utah; and.'}, {'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Beddhu', 'Affiliation': 'Medicine Section, Veterans Affairs Salt Lake City Health Care System, Salt Lake City, Utah; and.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.06600619']
986,32122284,Racial exclusion causes acute cortisol release among emerging-adult African Americans: The role of reduced perceived control.,"Racial discrimination contributes to stress-related health disparities among African Americans, but less is known about the acute effects of racial exclusion on the hypo-pituitary-adrenocortical response and psychological mediators. Participants were 276 Black/African American emerging-adults (54% female;  M   age  = 21.74,  SD  = 2.21) who were randomly assigned to be excluded or included by White peers via the game Cyberball. Racial exclusion (vs. inclusion) predicted: greater negative affect ( F (1, 276) = 104.885,  p  < .0001), lower perceived control ( F (1, 276) = 205.523,  p  < .0001), and greater cortisol release ( F (1, 274) = 4.575,  p  = .033). Racial exclusion's impact on cortisol release was mediated by lower perceived control (95% CI: .027, .112), but not negative affect (-.041, .013). These findings suggest that racial exclusion contributes to acute cortisol release, and that reduced perceived control is a consequence of racial discrimination that has important implications for the health of those who experience discrimination.",2020,"Racial exclusion (vs. inclusion) predicted: greater negative affect ( F (1, 276) = 104.885,  ","['African Americans', 'adult African Americans', 'Participants were 276 Black/African American emerging-adults (54% female;  M age \xa0=\xa021.74,  SD \xa0=\xa02.21) who were randomly assigned to be excluded or included by White peers via the game Cyberball']",[],"['greater cortisol release', 'cortisol release']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517630', 'cui_str': '2.21'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]",[],"[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]",276.0,0.0475374,"Racial exclusion (vs. inclusion) predicted: greater negative affect ( F (1, 276) = 104.885,  ","[{'ForeName': 'Laurel M', 'Initials': 'LM', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychology, Bryn Mawr College.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Stock', 'Affiliation': 'Department of Psychological and Brain Sciences, The George Washington University.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Monroe', 'Affiliation': 'Department of Psychology, Bryn Mawr College.'}, {'ForeName': 'Brianne K', 'Initials': 'BK', 'LastName': 'Molloy-Paolillo', 'Affiliation': 'Department of Psychological and Brain Sciences, The George Washington University.'}, {'ForeName': 'Sharon F', 'Initials': 'SF', 'LastName': 'Lambert', 'Affiliation': 'Department of Psychological and Brain Sciences, The George Washington University.'}]",The Journal of social psychology,['10.1080/00224545.2020.1729685']
987,30892564,Effectiveness of Self-guided App-Based Virtual Reality Cognitive Behavior Therapy for Acrophobia: A Randomized Clinical Trial.,"Importance


Globally, access to evidence-based psychological treatment is limited. Innovative self-help methods using smartphone applications and low-cost virtual reality have the potential to significantly improve the accessibility and scalability of psychological treatments.
Objective


To examine the effectiveness of ZeroPhobia, a fully self-guided app-based virtual reality cognitive behavior therapy (VR CBT) using low-cost (cardboard) virtual reality goggles compared with a wait-list control group and to determine its user friendliness.
Design, Setting, and Participants


In a single-blind randomized clinical trial, participants were enrolled between March 24 and September 28, 2017, and randomly assigned (1:1) by an independent researcher to either VR CBT app or a wait-list control group. A total of 193 individuals aged 18 to 65 years from the Dutch general population with acrophobia symptoms and access to an Android smartphone participated. The 6 animated modules of the VR-CBT app and gamified virtual reality environments were delivered over a 3-week period in participants' natural environment. Assessments were completed at baseline, immediately after treatment, and at 3-month follow-up. Analysis began April 6, 2018, and was intention to treat.
Intervention


Self-guided app-based VR CBT.
Main Outcomes and Measures


The primary outcome measure was the Acrophobia Questionnaire. The hypothesis was formulated prior to data collection.
Results


In total, 193 participants (129 women [66.84%]; mean [SD] age, 41.33 [13.64] years) were randomly assigned to intervention (n = 96) or a wait-list control group (n = 97). An intent-to-treat analysis showed a significant reduction of acrophobia symptoms at posttest at 3 months for the VR-CBT app compared with the controls (b = -26.73 [95% CI, -32.12 to -21.34]; P < .001; d = 1.14 [95% CI, 0.84 to 1.44]). The number needed to treat was 1.7. Sensitivity and robustness analysis confirmed these findings. Pretreatment attrition was 22 of 96 (23%) because of smartphone incompatibility. Of the 74 participants who started using the VR-CBT app, 57 (77%) completed the intervention fully.
Conclusions and Relevance


A low-cost fully self-guided app-based virtual reality cognitive behavioral therapy with rudimentary virtual reality goggles can produce large acrophobia symptom reductions. To our knowledge, this study is the first to show that virtual reality acrophobia treatment can be done at home without the intervention of a therapist.
Trial Registration


Trialregister.nl identifier: NTR6442.",2019,"An intent-to-treat analysis showed a significant reduction of acrophobia symptoms at posttest at 3 months for the VR-CBT app compared with the controls (b = -26.73 [95% CI, -32.12 to -21.34]; P < .001; d = 1.14 [95% CI, 0.84 to 1.44]).","['193 participants (129 women [66.84%]; mean [SD] age,\u200941.33 [13.64] years', '193 individuals aged 18 to 65 years from the Dutch general population with acrophobia symptoms and access to an Android smartphone participated', '74 participants who started using the VR-CBT app, 57 (77%) completed the intervention fully', 'Acrophobia', 'participants were enrolled between March 24 and September 28, 2017, and randomly assigned (1:1) by an independent researcher to either']","['VR CBT app or a wait-list control group', 'Self-guided App-Based Virtual Reality Cognitive Behavior Therapy', 'wait-list control group', 'Intervention\n\n\nSelf-guided app-based VR CBT', 'ZeroPhobia, a fully self-guided app-based virtual reality cognitive behavior therapy (VR CBT) using low-cost (cardboard) virtual reality goggles']","['Pretreatment attrition', 'Acrophobia Questionnaire', 'acrophobia symptoms']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0233701', 'cui_str': 'Fear of heights (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0718532', 'cui_str': 'Android'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018020', 'cui_str': 'Goggles'}]","[{'cui': 'C0233701', 'cui_str': 'Fear of heights (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",193.0,0.0841422,"An intent-to-treat analysis showed a significant reduction of acrophobia symptoms at posttest at 3 months for the VR-CBT app compared with the controls (b = -26.73 [95% CI, -32.12 to -21.34]; P < .001; d = 1.14 [95% CI, 0.84 to 1.44]).","[{'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Donker', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Section Clinical Psychology, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Ilja', 'Initials': 'I', 'LastName': 'Cornelisz', 'Affiliation': 'Department of Education Sciences, Section Methods and Statistics, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'van Klaveren', 'Affiliation': 'Department of Education Sciences, Section Methods and Statistics, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Annemieke', 'Initials': 'A', 'LastName': 'van Straten', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Section Clinical Psychology, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Carlbring', 'Affiliation': 'Department of Psychology, University Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Cuijpers', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Section Clinical Psychology, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'van Gelder', 'Affiliation': 'Department of Psychology of Conflict, Risk and Safety, University of Twente, Enschede, Amsterdam, the Netherlands.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.0219']
988,30730774,The Parent-Child Relationship and Posttreatment Child Outcomes Across Two Treatments for Oppositional Defiant Disorder.,"This study examined the degree to which the parent-child relationship uniquely predicted clinical outcomes in externalizing problems and adaptive skills in children meeting diagnostic criteria for oppositional defiant disorder and whether facets of this relationship moderated the effects of two unique psychosocial treatments. We recruited 134 children and their parents (38.06% female;  M  age = 9.52 years, range = 7-14; 83.58% White). Families were randomly assigned to 1 of 2 treatments: Parent Management Training (PMT) and Collaborative and Proactive Solutions (CPS). We formed principal components from pretreatment reports and behaviors of the parent-child relationship to predict within- and between-family outcomes in children's externalizing problems and adaptive skills. Four principal components were supported (parental warmth, parental monitoring, family hostility, and family permissiveness). Parental monitoring predicted fewer externalizing problems, whereas family permissiveness predicted more externalizing problems. Parental warmth predicted greatest improvements in children's adaptive skills among families receiving PMT. Family hostility predicted more externalizing problems and poorer adaptive skills for children; however, families receiving CPS were buffered from the negative effect of family hostility on adaptive skills. The parent-child relationship can uniquely inform posttreatment outcomes following treatment for oppositional defiant disorder. Certain treatment approaches may better fit unique relationships that emphasize warmth and/or hostility, allowing clinicians to anticipate and tailor treatments to families.",2020,"Four principal components were supported (parental warmth, parental monitoring, family hostility, and family permissiveness).","[""children's externalizing problems and adaptive skills"", 'children meeting diagnostic criteria for oppositional defiant disorder', '134 children and their parents (38.06% female; M age\xa0']",['Parent Management Training (PMT) and Collaborative and Proactive Solutions (CPS'],"['externalizing problems and poorer adaptive skills', ""children's adaptive skills"", 'externalizing problems']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0029121', 'cui_str': 'Oppositional Defiant Disorder'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C4517748', 'cui_str': 'Thirty-eight point zero six'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",134.0,0.0478645,"Four principal components were supported (parental warmth, parental monitoring, family hostility, and family permissiveness).","[{'ForeName': 'Jordan A', 'Initials': 'JA', 'LastName': 'Booker', 'Affiliation': 'Department of Psychological Sciences, University of Missouri.'}, {'ForeName': 'Nicole N', 'Initials': 'NN', 'LastName': 'Capriola-Hall', 'Affiliation': 'Department of Psychology, University of Alabama.'}, {'ForeName': 'Ross W', 'Initials': 'RW', 'LastName': 'Greene', 'Affiliation': 'Child Study Center, Virginia Tech.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Ollendick', 'Affiliation': 'Child Study Center, Virginia Tech.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2018.1555761']
989,31141104,P2Y12 Inhibitor Switching in Response to Routine Notification of CYP2C19 Clopidogrel Metabolizer Status Following Acute Coronary Syndromes.,"Importance


Physician behavior in response to knowledge of a patient's CYP2C19 clopidogrel metabolizer status is unknown.
Objective


To investigate the association of mandatory reporting of CYP2C19 pharmacogenomic testing, provided to investigators with no direct recommendations on how to use these results, with changes in P2Y12 inhibitor use, particularly clopidogrel, in the Randomized Trial to Compare the Safety of Rivaroxaban vs Aspirin in Addition to Either Clopidogrel or Ticagrelor in Acute Coronary Syndrome (GEMINI-ACS-1) clinical trial.
Design, Setting, and Participants


The GEMINI-ACS-1 trial compared rivaroxaban, 2.5 mg twice daily, with aspirin, 100 mg daily, plus open-label clopidogrel or ticagrelor (provided), in patients with recent acute coronary syndromes (ACS). The trial included 371 clinical centers in 21 countries and 3037 patients with ACS. Data were analyzed between May 2017 and February 2019.
Interventions


Investigators were required to prestipulate their planned response to CYP2C19 metabolizer status. In response to a regulatory mandate, results for all patients were reported to investigators approximately 1 week after randomization.
Main Outcomes and Measures


Reasons for switching P2Y12 inhibitors and occurrence of bleeding and ischemic events were collected.
Results


Of 3037 patients enrolled (mean [SD] age, 62.8 [9.0] years; 2275 men [74.9%], and 2824 white race/ethnicity [93.0%]), investigators initially treated 1704 (56.1%) with ticagrelor and 1333 (43.9%) with clopidogrel. Investigators prestipulated that they would use CYP2C19 metabolizer status to change P2Y12 inhibitor in 48.5% of genotyped clopidogrel-treated patients (n = 642 of 1324) and 5.5% of genotyped ticagrelor-treated patients (n = 93 of 1692). P2Y12 inhibitor switching for any reason occurred in 197 patients and was more common in patients treated with ticagrelor (146 of 1704 [8.6%]) compared with clopidogrel (51 of 1333 [3.8%]). Of patients initially treated with ticagrelor, only 1 (0.1% overall; 0.7% of all who switched) was switched based on CYP2C19 status. Of patients initially treated with clopidogrel, 23 (1.7% overall,;45.1% of all who switched) were switched owing to metabolizer status. Of 48 patients (3.6%) with reduced metabolizer status treated initially with clopidogrel, 15 (31.3%) were switched based on metabolizer status, including 48.1% (13 of 27) in which switching was prestipulated.
Conclusions and Relevance


Physicians were evenly split on how to respond to knowledge of CYP2C19 metabolizer status in clopidogrel-treated patients. Mandatory provision of this information rarely prompted P2Y12 inhibitor switching overall, including a minority of patients with reduced metabolizer status. These findings highlight the clinical equipoise among physicians regarding use of this information and the reluctance to use information from routine genotyping in the absence of definitive clinical trial data demonstrating the efficacy of this approach.
Clinical Trial Registration


ClinicalTrials.gov identifier: NCT02293395.",2019,"Of patients initially treated with clopidogrel, 23 (1.7% overall,;45.1% of all who switched) were switched owing to metabolizer status.","['371 clinical centers in 21 countries and 3037 patients with ACS', 'patients with recent acute coronary syndromes (ACS', '3037 patients enrolled (mean [SD] age, 62.8 [9.0] years; 2275 men [74.9%], and 2824 white race/ethnicity [93.0%]), investigators initially treated 1704 (56.1%) with ticagrelor and 1333 (43.9%) with', '48 patients (3.6%) with reduced metabolizer status treated initially with', 'Acute Coronary Syndrome']","['CYP2C19 Clopidogrel Metabolizer', 'rivaroxaban', 'ticagrelor', 'Clopidogrel or Ticagrelor', 'aspirin, 100 mg daily, plus open-label clopidogrel or ticagrelor', 'Rivaroxaban vs Aspirin', 'clopidogrel']",['Measures\n\n\nReasons for switching P2Y12 inhibitors and occurrence of bleeding and ischemic events'],"[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C3714749', 'cui_str': ""S-Mephenytoin 4'-Hydroxylase""}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",3037.0,0.0356846,"Of patients initially treated with clopidogrel, 23 (1.7% overall,;45.1% of all who switched) were switched owing to metabolizer status.","[{'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Povsic', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'E Magnus', 'Initials': 'EM', 'LastName': 'Ohman', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Roe', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'White', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Frank W', 'Initials': 'FW', 'LastName': 'Rockhold', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'Sorbonne Université, ACTION Study Group, Institut de Cardiologie, Pitié-Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'Jan H', 'Initials': 'JH', 'LastName': 'Cornel', 'Affiliation': 'Department of Cardiology, Noordwest Ziekenhuisgroep, Alkmaar and Dutch Network for Cardiovascular Research, the Netherlands.'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Insituto do Coracao, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'P Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'DHU FIRE, Université Paris-Diderot, AP-HP and Inserm U-1148, Paris, France.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'James', 'Affiliation': 'Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Bode', 'Affiliation': 'University of Freiburg, Faculty of Medicine, Internal Medicine III, Freiburg, Germany.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Welsh', 'Affiliation': 'Mazankowski Alberta Heart Institute and University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Alexei N', 'Initials': 'AN', 'LastName': 'Plotnikov', 'Affiliation': 'Janssen Research and Development, Raritan, New Jersey.'}, {'ForeName': 'Hardi', 'Initials': 'H', 'LastName': 'Mundl', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Gibson', 'Affiliation': 'PERFUSE Study Group, Beth Israel Deaconess Hospital, Harvard Medical School, Boston, Massachusetts.'}]",JAMA cardiology,['10.1001/jamacardio.2019.1510']
990,30624598,"Effect of a hypocaloric, nutritionally complete, higher-protein meal plan on bone density and quality in older adults with obesity: a randomized trial.","Background


Dietary protein and micronutrients are important to the maintenance of bone health and may be an effective countermeasure to weight-loss-associated bone loss.
Objectives


We aimed to determine the effect of a 6-mo hypocaloric, nutritionally complete, higher-protein meal plan on change in bone density and quality as compared with weight stability in older adults using a randomized post-test design. We hypothesized that participants randomly assigned to this meal plan would maintain similar bone density and quality to weight-stable controls, despite significant reductions in body mass.
Methods


Ninety-six older adults (aged 70.3 ± 3.7 y, 74% women, 27% African American) with obesity [body mass index (kg/m2): 35.4 ± 3.3] were randomly assigned to a 6-mo hypocaloric, nutritionally complete, higher-protein meal plan targeting ≥1.0 g protein · kg body weight-1 · d-1 [weight-loss (WL) group; n = 47] or to a weight-stability (WS) group targeting 0.8 g protein · kg body weight-1 · d-1, the current Recommended Dietary Allowance (n = 49). The primary outcome was total hip bone mineral density (BMD), with femoral neck BMD, lumbar spine BMD, and lumbar spine trabecular bone score (TBS) as secondary outcomes, all assessed at baseline and 3 and 6 mo with dual-energy X-ray absorptiometry.
Results


Baseline total hip, femoral neck, and lumbar spine BMDs were 1.016 ± 0.160, 0.941 ± 0.142, and 1.287 ± 0.246 g/cm2, respectively; lumbar TBS was 1.398 ± 0.109. Despite significant weight loss achieved in the WL group (6.6 ± 0.4 kg; 8.6% ± 0.4% of baseline weight), 6-mo regional BMD estimates were similar to those in the WS group (all P > 0.05). Lumbar spine TBS significantly increased at 6 mo in the WL group (mean: 1.421; 95% CI: 1.401, 1.441) compared with the WS group (1.390: 95% CI: 1.370, 1.409; P = 0.02).
Conclusions


Older adults following a hypocaloric, nutritionally complete, higher-protein meal plan maintained similar bone density and quality to weight-stable controls. Our data suggest that adherence to this diet does not produce loss of hip and spine bone density in older adults and may improve bone quality. This trial was registered at clinicaltrials.gov as NCT02730988.",2019,"Lumbar spine TBS significantly increased at 6 mo in the WL group (mean: 1.421; 95% CI: 1.401, 1.441) compared with the WS group (1.390: 95% CI: 1.370, 1.409; P = 0.02).
","['Methods\n\n\nNinety-six older adults (aged 70.3\xa0±\xa03.7 y, 74% women, 27% African American) with obesity [body mass index (kg/m2): 35.4\xa0±\xa03.3', 'older adults with obesity', 'Older adults', 'older adults']","['hypocaloric, nutritionally complete, higher-protein meal plan', '6-mo hypocaloric, nutritionally complete, higher-protein meal plan targeting ≥1.0 g protein · kg body weight-1 · d-1 [weight-loss (WL) group; n\xa0=\xa047] or to a weight-stability (WS) group targeting 0.8 g protein · kg body weight-1 · d-1, the current Recommended Dietary Allowance', '6-mo hypocaloric, nutritionally complete, higher-protein meal plan']","['weight loss', 'Baseline total hip, femoral neck, and lumbar spine BMDs', 'regional BMD estimates', 'total hip bone mineral density (BMD), with femoral neck BMD, lumbar spine BMD, and lumbar spine trabecular bone score (TBS', 'bone density and quality', 'Lumbar spine TBS', 'bone quality']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517696', 'cui_str': '3.7 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C4517688', 'cui_str': '3.3 (qualifier value)'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0530867', 'cui_str': 'G13 Protein'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0524787', 'cui_str': 'Recommended Dietary Allowances'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0030786', 'cui_str': 'Hip Bone'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0222660', 'cui_str': 'Spongy Bone'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}]",96.0,0.1309,"Lumbar spine TBS significantly increased at 6 mo in the WL group (mean: 1.421; 95% CI: 1.401, 1.441) compared with the WS group (1.390: 95% CI: 1.370, 1.409; P = 0.02).
","[{'ForeName': 'Ashley A', 'Initials': 'AA', 'LastName': 'Weaver', 'Affiliation': 'Department of Biomedical Engineering, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Denise K', 'Initials': 'DK', 'LastName': 'Houston', 'Affiliation': 'Department of Internal Medicine, Section on Gerontology and Geriatric Medicine.'}, {'ForeName': 'Sue A', 'Initials': 'SA', 'LastName': 'Shapses', 'Affiliation': 'Department of Nutritional Sciences.'}, {'ForeName': 'Mary F', 'Initials': 'MF', 'LastName': 'Lyles', 'Affiliation': 'Department of Internal Medicine, Section on Gerontology and Geriatric Medicine.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Henderson', 'Affiliation': 'Department of Internal Medicine, Section on Gerontology and Geriatric Medicine.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Beavers', 'Affiliation': 'Department of Biostatistical Sciences, Rutgers University, New Brunswick, NJ.'}, {'ForeName': 'Arlynn C', 'Initials': 'AC', 'LastName': 'Baker', 'Affiliation': 'Department of Biomedical Engineering, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Kristen M', 'Initials': 'KM', 'LastName': 'Beavers', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqy237']
991,30522343,Oral Vitamin C (500 mg/d) to Pregnant Smokers Improves Infant Airway Function at 3 Months (VCSIP). A Randomized Trial.,"Rationale:  We reported a randomized trial demonstrating daily supplemental vitamin C to pregnant smokers significantly improved newborn pulmonary function tests. The current study tests these results in a new cohort using infant pulmonary function tests.  Objectives:  To determine if infants of pregnant smokers randomized to daily supplemental vitamin C would have improved forced expiratory flows (FEFs) at 3 months of age compared with those randomized to placebo, and to investigate the association of the α5 nicotinic acetylcholine receptor.  Methods:  A randomized, double-blind, placebo-controlled trial was conducted at three centers. Two hundred fifty-one pregnant smokers were randomized at 13-23 weeks of gestation: 125 randomized to vitamin C (500 mg/d) and 126 to placebo.  Measurements and Main Results:  The primary outcome was FEF 75  at 3 months of age performed with the raised volume rapid thoracic compression technique (Jaeger/Viasys). FEF 50  and FEF 25-75  obtained from the same expiratory curves were prespecified secondary outcomes. The infants of pregnant smokers randomized to vitamin C ( n  = 113) had the following FEFs at 3 months of age compared with those randomized to placebo ( n  =  109) as measured by FEF 75  (200.7 vs. 188.7 ml/s; adjusted 95% confidence interval [CI] for difference, -3.33 to 35.64;  P  = 0.10), FEF 50  (436.7 vs. 408.5 ml/s; adjusted 95% CI for difference, 6.10-61.30;  P  = 0.02), and FEF 25-75  (387.4 vs. 365.8 ml/s; adjusted 95% CI for difference, 0.92-55.34;  P  = 0.04). Infant FEFs seemed to be negatively associated with the maternal risk alleles for the α5 nicotinic acetylcholine receptor (rs16969968).  Conclusions:  Although the primary outcome of FEF 75  was not improved after vitamin C supplementation to pregnant smokers, the predetermined secondary outcomes FEF 50  and FEF 25-75  were significantly improved. These results extend our previous findings and demonstrate improved airway function (FEF 50  and FEF 25-75 ) at 3 months of age in infants after vitamin C supplementation to pregnant smokers. Clinical trial registered with www.clinicaltrials.gov (NCT01723696).",2019,These results extend our previous findings and demonstrate improved airway function (FEF 50  and FEF 25-75 ) at 3 months of age in infants after vitamin C supplementation to pregnant smokers.,"['Pregnant Smokers', 'Two hundred fifty-one pregnant smokers', 'infants of pregnant smokers']","['vitamin C', 'placebo', 'vitamin C supplementation', 'Oral Vitamin C', 'daily supplemental vitamin C']","['airway function', 'FEF 75', 'FEF 75  at 3 months of age performed with the raised volume rapid thoracic compression technique (Jaeger/Viasys', 'newborn pulmonary function tests', 'forced expiratory flows (FEFs']","[{'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4524018', 'cui_str': 'Vitamin C supplementation'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0442818', 'cui_str': 'Raised (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0325865', 'cui_str': 'Jaeger'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C3804964', 'cui_str': 'Forced expiratory flow'}]",251.0,0.55774,These results extend our previous findings and demonstrate improved airway function (FEF 50  and FEF 25-75 ) at 3 months of age in infants after vitamin C supplementation to pregnant smokers.,"[{'ForeName': 'Cindy T', 'Initials': 'CT', 'LastName': 'McEvoy', 'Affiliation': '1 Department of Pediatrics.'}, {'ForeName': 'Lyndsey E', 'Initials': 'LE', 'LastName': 'Shorey-Kendrick', 'Affiliation': '2 Division of Neuroscience, Oregon National Primate Research Center, Beaverton, Oregon.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Milner', 'Affiliation': '1 Department of Pediatrics.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Schilling', 'Affiliation': '1 Department of Pediatrics.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Tiller', 'Affiliation': '3 Department of Pediatrics and.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Vuylsteke', 'Affiliation': '1 Department of Pediatrics.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Scherman', 'Affiliation': '1 Department of Pediatrics.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Jackson', 'Affiliation': '4 PeaceHealth Southwest Medical Center, Vancouver, Washington.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Haas', 'Affiliation': '5 Department of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Harris', 'Affiliation': '1 Department of Pediatrics.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Schuff', 'Affiliation': '6 Department of Medical Informatics and Clinical Epidemiology.'}, {'ForeName': 'Byung S', 'Initials': 'BS', 'LastName': 'Park', 'Affiliation': '8 Oregon Health & Science University-Portland State University School of Public Health and Knight Cancer Institute, Portland, Oregon; and.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Vu', 'Affiliation': '6 Department of Medical Informatics and Clinical Epidemiology.'}, {'ForeName': 'Dale F', 'Initials': 'DF', 'LastName': 'Kraemer', 'Affiliation': '6 Department of Medical Informatics and Clinical Epidemiology.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Mitchell', 'Affiliation': '7 Oregon Clinical & Translational Research Institute, and.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Metz', 'Affiliation': '6 Department of Medical Informatics and Clinical Epidemiology.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gonzales', 'Affiliation': '9 Division of Pulmonary & Critical Care Medicine, Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Bunten', 'Affiliation': '10 Vancouver Clinic, Vancouver, Washington.'}, {'ForeName': 'Eliot R', 'Initials': 'ER', 'LastName': 'Spindel', 'Affiliation': '2 Division of Neuroscience, Oregon National Primate Research Center, Beaverton, Oregon.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Tepper', 'Affiliation': '3 Department of Pediatrics and.'}, {'ForeName': 'Cynthia D', 'Initials': 'CD', 'LastName': 'Morris', 'Affiliation': '6 Department of Medical Informatics and Clinical Epidemiology.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201805-1011OC']
992,30489151,1470 nm Diode Laser Enucleation vs Plasmakinetic Resection of the Prostate for Benign Prostatic Hyperplasia: A Randomized Study.,"OBJECTIVE


The purpose of the current work was to comparatively assess 1470 nm diode laser enucleation of the prostate (DiLEP) and plasmakinetic resection of the prostate (PKRP) for treating benign prostatic hyperplasia (BPH).
PATIENTS AND METHODS


From January 2016 to March 2017, 157 individuals with bladder outflow obstruction caused by BPH were randomized to DiLEP and PKRP groups, for prospective analysis. Of these, 152 cases were evaluated before operation and at 3, 6, and 12 months postsurgery. Patient baseline properties, presurgery data, and postsurgical outcomes were comparatively assessed, as well as complications.
RESULTS


There were no significant preoperative differences between surgical groups. DiLEP-treated cases showed remarkable reduced operative time, postsurgical bladder irrigation time, catheterization duration, and hospital stay compared with the PKRP group (P < 0.001). Hemoglobin amount decrease was markedly less pronounced after DiLEP (P = 0.004). However, no patients needed blood transfusion in either group. The decrease in sodium level showed no marked differences between the DiLEP and PKRP groups (P = 0.380). In addition, complications were comparable and no significant differences in both groups. At 3, 6, and 12 months, International Prostate Symptom Score (IPSS), quality of life (QoL), maximum flow rate (Qmax), and postvoid residual (PVR) were similar in both groups (P > 0.05).
CONCLUSIONS


DiLEP and PKRP are similar in efficacy and safety for relieving obstruction and low urinary tract symptoms. Compared with PKRP, DiLEP has decreased risk of hemorrhage, operative time, bladder irrigation time, catheterization duration, and hospital stay. However, IPSS, QoL, Qmax, and PVR were similar for both procedures within 12 postoperative months.",2019,"DiLEP-treated cases showed remarkable reduced operative time, postsurgical bladder irrigation time, catheterization duration, and hospital stay compared with the PKRP group (P < 0.001).","['From January 2016 to March 2017, 157 individuals with bladder outflow obstruction caused by BPH', '1470\u2009nm', 'Benign Prostatic Hyperplasia']","['diode laser enucleation of the prostate (DiLEP) and plasmakinetic resection of the prostate (PKRP', 'PKRP, DiLEP', 'DiLEP and PKRP', 'Diode Laser Enucleation vs Plasmakinetic Resection of the Prostate']","['operative time, postsurgical bladder irrigation time, catheterization duration, and hospital stay', 'sodium level', 'Hemoglobin amount decrease', 'IPSS, QoL, Qmax, and PVR', 'International Prostate Symptom Score (IPSS), quality of life (QoL), maximum flow rate (Qmax), and postvoid residual (PVR', 'blood transfusion', 'risk of hemorrhage, operative time, bladder irrigation time, catheterization duration, and hospital stay']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0005001', 'cui_str': 'Benign enlargement of prostate'}, {'cui': 'C1704272', 'cui_str': 'Benign Prostatic Hyperplasia'}]","[{'cui': 'C0392254', 'cui_str': 'Semiconductor Diode Lasers'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0194423', 'cui_str': 'Bladder irrigation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0428291', 'cui_str': 'Finding of sodium level (finding)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0034380'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}]",,0.0427916,"DiLEP-treated cases showed remarkable reduced operative time, postsurgical bladder irrigation time, catheterization duration, and hospital stay compared with the PKRP group (P < 0.001).","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Urology, The Fifth People's Hospital of Shanghai, Fudan University, Shanghai, P.R. China.""}, {'ForeName': 'Xilong', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Urology, The Fifth People's Hospital of Shanghai, Fudan University, Shanghai, P.R. China.""}, {'ForeName': 'Yanbin', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Urology, The Fifth People's Hospital of Shanghai, Fudan University, Shanghai, P.R. China.""}, {'ForeName': 'Chaoliang', 'Initials': 'C', 'LastName': 'Shi', 'Affiliation': ""Department of Urology, The Fifth People's Hospital of Shanghai, Fudan University, Shanghai, P.R. China.""}, {'ForeName': 'Minqi', 'Initials': 'M', 'LastName': 'Tu', 'Affiliation': ""Department of Urology, The Fifth People's Hospital of Shanghai, Fudan University, Shanghai, P.R. China.""}, {'ForeName': 'Guowei', 'Initials': 'G', 'LastName': 'Shi', 'Affiliation': ""Department of Urology, The Fifth People's Hospital of Shanghai, Fudan University, Shanghai, P.R. China.""}]",Journal of endourology,['10.1089/end.2018.0499']
993,32092081,Modifiable motion graphics for capturing sensations.,"OBJECTIVE


The purpose of this study was to assess the relationship between an embodied sensory experience and the ability to translate the perception of this experience visually using modifiable motion graphics.
METHODS


A custom-designed software was developed to enable users to modify a motion graphic in real-time. The motion graphics were designed to depict realistic visualizations of pain quality descriptors, such as tingling and burning. Participants (N = 34) received an electrical stimulation protocol known to elicit sensations of tingling. The protocol consisted of eight stimulation intensities ranging from 2-6mA delivered, in a randomized fashion and repeated three times, to the index finger. Immediately after each stimulus, participants drew the area of the evoked sensation on a digital body chart of the hand. Participants then modified the motion graphic of tingling by adjusting two parameters, namely the speed (rate of dots disappearing and re-appearing) and density of these dots in the drawn area. Then, participants rated the perceived intensity and selected the most appropriate pain quality descriptor.
RESULTS


There was an increase in the area, density, and perceived intensity ratings as the electrical stimulation intensity increased (P<0.001). The density of the motion graphic, but not speed, correlated with perceived intensity ratings (0.69, P<0.001) and electrical stimulation intensities (0.63, P<0.01). The descriptor 'tingling' was predominantly selected in the range of 3-4.5mA and was often followed by 'stabbing' as the electrical intensity increased.
DISCUSSION


The motion graphic tested was perceived to reflect a tingling sensation, the stimulation protocol elicited a tingling sensation, and participants adjusted one of the two motion graphic features systematically. In conclusion, an embodied sensation, such as tingling, maybe visually represented similarly between individuals. These findings create research, clinical, and commercial opportunities that utilize psychophysics to explore, visualize, and quantify changes in embodied sensory experiences in response to known stimuli.",2020,"There was an increase in the area, density, and perceived intensity ratings as the electrical stimulation intensity increased (P<0.001).",['Participants (N = 34'],['electrical stimulation protocol known to elicit sensations of tingling'],"[""descriptor 'tingling"", 'intensity ratings', 'electrical stimulation intensities', 'area, density, and perceived intensity ratings as the electrical stimulation intensity', 'density of the motion graphic']",[],"[{'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C2242996', 'cui_str': 'Tingling'}]","[{'cui': 'C0282354', 'cui_str': 'Descriptors'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}]",,0.0442294,"There was an increase in the area, density, and perceived intensity ratings as the electrical stimulation intensity increased (P<0.001).","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Galve Villa', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), Center for Sensory-Motor Interaction (SMI)®, Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'D Mørch', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), Center for Sensory-Motor Interaction (SMI)®, Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Thorvaldur', 'Initials': 'T', 'LastName': 'S Palsson', 'Affiliation': 'Laboratory for Musculoskeletal Pain and Motor Control, Center for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Shellie A', 'Initials': 'SA', 'LastName': 'Boudreau', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), Center for Sensory-Motor Interaction (SMI)®, Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, Denmark.'}]",PloS one,['10.1371/journal.pone.0229139']
994,29487402,Ketamine has distinct electrophysiological and behavioral effects in depressed and healthy subjects.,"Ketamine's mechanism of action was assessed using gamma power from magnetoencephalography (MEG) as a proxy measure for homeostatic balance in 35 unmedicated subjects with major depressive disorder (MDD) and 25 healthy controls enrolled in a double-blind, placebo-controlled, randomized cross-over trial of 0.5 mg/kg ketamine. MDD subjects showed significant improvements in depressive symptoms, and healthy control subjects exhibited modest but significant increases in depressive symptoms for up to 1 day after ketamine administration. Both groups showed increased resting gamma power following ketamine. In MDD subjects, gamma power was not associated with the magnitude of the antidepressant effect. However, baseline gamma power was found to moderate the relationship between post-ketamine gamma power and antidepressant response; specifically, higher post-ketamine gamma power was associated with better response in MDD subjects with lower baseline gamma, with an inverted relationship in MDD subjects with higher baseline gamma. This relationship was observed in multiple regions involved in networks hypothesized to be involved in the pathophysiology of MDD. This finding suggests biological subtypes based on the direction of homeostatic dysregulation and has important implications for inferring ketamine's mechanism of action from studies of healthy controls alone.",2019,"MDD subjects showed significant improvements in depressive symptoms, and healthy control subjects exhibited modest but significant increases in depressive symptoms for up to 1 day after ketamine administration.","['depressed and healthy subjects', '35 unmedicated subjects with major depressive disorder (MDD) and 25 healthy controls enrolled']","['Ketamine', 'ketamine', 'gamma power from magnetoencephalography (MEG', 'placebo']","['depressive symptoms', 'resting gamma power']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1552644', 'cui_str': 'Greek letter gamma'}, {'cui': 'C0024489', 'cui_str': 'Magnetoencephalography'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1552644', 'cui_str': 'Greek letter gamma'}]",35.0,0.0308105,"MDD subjects showed significant improvements in depressive symptoms, and healthy control subjects exhibited modest but significant increases in depressive symptoms for up to 1 day after ketamine administration.","[{'ForeName': 'Allison C', 'Initials': 'AC', 'LastName': 'Nugent', 'Affiliation': 'Experimental Therapeutics and Pathophysiology Branch, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA. nugenta@mail.nih.gov.'}, {'ForeName': 'Elizabeth D', 'Initials': 'ED', 'LastName': 'Ballard', 'Affiliation': 'Experimental Therapeutics and Pathophysiology Branch, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Gould', 'Affiliation': 'Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Lawrence T', 'Initials': 'LT', 'LastName': 'Park', 'Affiliation': 'Experimental Therapeutics and Pathophysiology Branch, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Ruin', 'Initials': 'R', 'LastName': 'Moaddel', 'Affiliation': 'Laboratory of Clinical Investigation, National Institute on Aging, Baltimore, MD, USA.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Brutsche', 'Affiliation': 'Experimental Therapeutics and Pathophysiology Branch, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Zarate', 'Affiliation': 'Experimental Therapeutics and Pathophysiology Branch, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}]",Molecular psychiatry,['10.1038/s41380-018-0028-2']
995,30653420,Two weeks of ischemic conditioning improves walking speed and reduces neuromuscular fatigability in chronic stroke survivors.,"This pilot study examined whether ischemic conditioning (IC), a noninvasive, cost-effective, and easy-to-administer intervention, could improve gait speed and paretic leg muscle function in stroke survivors. We hypothesized that 2 wk of IC training would increase self-selected walking speed, increase paretic muscle strength, and reduce neuromuscular fatigability in chronic stroke survivors. Twenty-two chronic stroke survivors received either IC or IC Sham on their paretic leg every other day for 2 wk (7 total sessions). IC involved 5-min bouts of ischemia, repeated five times, using a cuff inflated to 225 mmHg on the paretic thigh. For IC Sham, the cuff inflation pressure was 10 mmHg. Self-selected walking speed was assessed using the 10-m walk test, and paretic leg knee extensor strength and fatigability were assessed using a Biodex dynamometer. Self-selected walking speed increased in the IC group (0.86 ± 0.21 m/s pretest vs. 1.04 ± 0.22 m/s posttest, means ± SD; P < 0.001) but not in the IC Sham group (0.92 ± 0.47 m/s pretest vs. 0.96 ± 0.46 m/s posttest; P = 0.25). Paretic leg maximum voluntary contractions were unchanged in both groups (103 ± 57 N·m pre-IC vs. 109 ± 65 N·m post-IC; 103 ± 59 N·m pre-IC Sham vs. 108 ± 67 N·m post-IC Sham; P = 0.81); however, participants in the IC group maintained a submaximal isometric contraction longer than participants in the IC Sham group (278 ± 163 s pre-IC vs. 496 ± 313 s post-IC, P = 0.004; 397 ± 203 s pre-IC Sham vs. 355 ± 195 s post-IC Sham; P = 0.46). The results from this pilot study thus indicate that IC training has the potential to improve walking speed and paretic muscle fatigue resistance poststroke. NEW & NOTEWORTHY This pilot study is the first to demonstrate that ischemic conditioning can improve self-selected walking speed and reduce paretic muscle fatigue in stroke survivors. Ischemic conditioning has been shown to be safe in numerous patient populations, can be accomplished at home or at the bedside in only 45 min, and requires no specialized training. Future larger studies are warranted to determine the efficacy of ischemic conditioning as a neurorehabilitation therapy poststroke.",2019,"Ischemic conditioning has been shown to be safe in numerous patient populations, can be accomplished at home or at the bedside in only 45 min, and requires no specialized training.","['chronic stroke survivors', 'stroke survivors', 'Twenty-two chronic stroke survivors']","['IC or IC Sham', 'IC training', 'ischemic conditioning']","['10-m walk test, and paretic leg knee extensor strength and fatigability', 'Paretic leg maximum voluntary contractions', 'submaximal isometric contraction longer', 'gait speed and paretic leg muscle function', 'walking speed and reduces neuromuscular fatigability', 'self-selected walking speed, increase paretic muscle strength', 'cuff inflation pressure', 'walking speed and paretic muscle fatigue resistance poststroke', 'neuromuscular fatigability', 'Self-selected walking speed']","[{'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231230', 'cui_str': 'Fatigability (finding)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C0022205', 'cui_str': 'Isometric Contraction'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0231484', 'cui_str': 'Muscular activity'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1318493', 'cui_str': 'Inflation'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0242979', 'cui_str': 'Muscular Fatigue'}]",,0.0445232,"Ischemic conditioning has been shown to be safe in numerous patient populations, can be accomplished at home or at the bedside in only 45 min, and requires no specialized training.","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Durand', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Boerger', 'Affiliation': 'Department of Physical Therapy, Marquette University , Milwaukee, Wisconsin.'}, {'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Nguyen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Saad Z', 'Initials': 'SZ', 'LastName': 'Alqahtani', 'Affiliation': 'Department of Physical Therapy, Marquette University , Milwaukee, Wisconsin.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Wright', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Schmit', 'Affiliation': 'Department of Biomedical Engineering, Marquette University , Milwaukee, Wisconsin.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Gutterman', 'Affiliation': 'Department of Medicine, Medical College of Wisconsin , Milwaukee, Wisconsin.'}, {'ForeName': 'Allison S', 'Initials': 'AS', 'LastName': 'Hyngstrom', 'Affiliation': 'Department of Physical Therapy, Marquette University , Milwaukee, Wisconsin.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00772.2018']
996,31215832,The Influence of a Brief Alcohol Intervention on Alcohol Use Trajectories in Nonstudent Emerging Adult Drinkers.,"Background:  This study sought to inform research with noncollege-attending emerging adults, an at-risk, and understudied population, by identifying patterns of response following a brief alcohol intervention. This study was a reanalysis of data from a randomized controlled intervention trial testing a brief, personalized feedback alcohol intervention targeting nonstudent emerging adult drinkers.  Objectives:  The study aims were to (1) model intervention response by identifying subgroups characterized by changes in heavy drinking (i.e. peak use, number of binges during a typical week, proportion of binge days, peak estimated blood alcohol concentration [eBAC]) following the alcohol intervention, and (2) distinguish subgroups on factors related to intervention response (i.e. perceived norms regarding how much peers drink, alcohol use severity, mental health symptoms, and readiness to change).  Methods:  Participants were 81 (64.2% men) nonstudent heavy drinkers between ages 18-25 years (average age = 22.04) recruited from the community.  Results:  Findings revealed two latent subgroups that exhibited differential response to the intervention (i.e. intervention ""responders"" and ""nonresponders""). Further, responders reported higher pre-intervention descriptive normative perceptions and alcohol use severity.  Conclusions/Importance:  The current investigation contributed to knowledge regarding for whom brief alcohol interventions work in the short term within nonstudent emerging adults and could inform future research to facilitate behavior change in those unresponsive to intervention efforts.",2019,"Further, responders reported higher pre-intervention descriptive normative perceptions and alcohol use severity.  ","['adult drinkers', 'Participants were 81 (64.2% men) nonstudent heavy drinkers between ages 18-25\u2009years (average age = 22.04) recruited from the community', 'Nonstudent Emerging Adult Drinkers']","['personalized feedback alcohol intervention', 'Alcohol Intervention']","['peers drink, alcohol use severity, mental health symptoms, and readiness to change']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0337678', 'cui_str': 'Heavy drinker (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",81.0,0.0178797,"Further, responders reported higher pre-intervention descriptive normative perceptions and alcohol use severity.  ","[{'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Lau-Barraco', 'Affiliation': 'Department of Psychology, Old Dominion University , Norfolk , VA , USA.'}, {'ForeName': 'Ashley N', 'Initials': 'AN', 'LastName': 'Linden-Carmichael', 'Affiliation': 'Department of Biobehavioral Health and the Edna Bennett Pierce Prevention Research Center, The Pennsylvania State University , University Park , PA , USA.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Stamates', 'Affiliation': 'Department of Psychology, Old Dominion University , Norfolk , VA , USA.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Preonas', 'Affiliation': 'Virginia Consortium Program in Clinical Psychology , Norfolk , VA , USA.'}, {'ForeName': 'Abby L', 'Initials': 'AL', 'LastName': 'Braitman', 'Affiliation': 'Department of Psychology, Old Dominion University , Norfolk , VA , USA.'}]",Substance use & misuse,['10.1080/10826084.2019.1626434']
997,32143877,"A randomized controlled trial on inspiratory muscle training in pulmonary hypertension: Effects on respiratory functions, functional exercise capacity, physical activity, and quality of life.","BACKGROUND


Impaired respiratory muscle function may be one of the causes of increased dyspnea, reduced exercise capacity, and physical activity (PA), and poor quality of life in pulmonary hypertension (PH).
OBJECTIVE


To investigate the effects of threshold inspiratory muscle training (TIMT) on respiratory functions, functional exercise capacity, PA, and QoL in patients with PH.
METHODS


Thirty patients with PH were randomly allocated to a TIMT (n = 15) and sham group (n = 15). Three patients in the sham group could not participate in the program. The TIMT group (n = 15) trained at 30% of the maximal inspiratory pressure (MIP), and the sham group (n = 12) performed at lowest pressure without change in threshold pressure. In both groups, patients performed TIMT at home for 15 min, twice per day, with the MIP load determined by the trainer, and were supervised once weekly at the hospital for eight weeks. The primary outcomes were MIP and maximal expiratory pressure (MEP). The secondary outcome measures included spirometric measurements, six-minute walking distance (6MWD), PA (SenseWear armband and International Physical Activity Questionnaire-Short Form-IPAQ-Short Form), and QoL (Minnesota Living with Heart Failure-MLHF).
RESULTS


After the training, changes in MIP (p = 0.023) were higher in the intervention group compared with the sham group. Differences in MEP, FEV1 (%), FVC (%), FEV1/FVC (%), 6MWD, %6MWD, IPAQ-SF, MLHFQ, and armband parameters were not significantly different between the groups (p > 0.05).
CONCLUSIONS


The results of the study demonstrated that TIMT could increase MIP and did not improve other parameters of respiratory functions, functional exercise capacity, PA, and QoL in patients with PH.",2020,"After the training, changes in MIP (p = 0.023) were higher in the intervention group compared with the sham group.","['pulmonary hypertension', 'patients with PH.\nMETHODS\n\n\nThirty patients with PH', 'patients with PH']","['inspiratory muscle training', 'threshold inspiratory muscle training (TIMT', 'TIMT']","['respiratory functions, functional exercise capacity, physical activity, and quality of life', 'MIP and maximal expiratory pressure (MEP', 'MEP, FEV1 (%), FVC (%), FEV1/FVC (%), 6MWD, %6MWD, IPAQ-SF, MLHFQ, and armband parameters', 'changes in MIP', 'spirometric measurements, six-minute walking distance (6MWD), PA (SenseWear armband and International Physical Activity Questionnaire-Short Form-IPAQ-Short Form), and QoL (Minnesota Living with Heart Failure-MLHF', 'respiratory functions, functional exercise capacity, PA, and QoL']","[{'cui': 'C1963999', 'cui_str': 'Pulmonary hypertension (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training (regime/therapy)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}]","[{'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises (regime/therapy)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034380'}, {'cui': 'C4082175', 'cui_str': 'Maximal Expiratory Pressure'}, {'cui': 'C1301852', 'cui_str': 'Armband'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]",30.0,0.0970138,"After the training, changes in MIP (p = 0.023) were higher in the intervention group compared with the sham group.","[{'ForeName': 'Goksen Kuran', 'Initials': 'GK', 'LastName': 'Aslan', 'Affiliation': 'Istanbul University-Cerrahpasa, Faculty of Health Sciences, Division of Physiotherapy and Rehabilitation, Bakırköy, Istanbul, Turkey. Electronic address: goksenkuran@yahoo.com.'}, {'ForeName': 'Buket', 'Initials': 'B', 'LastName': 'Akıncı', 'Affiliation': 'Biruni University, Faculty of Health Sciences, Division of Physiotherapy and Rehabilitation, Istanbul, Turkey. Electronic address: barbuket@hotmail.com.'}, {'ForeName': 'Ipek', 'Initials': 'I', 'LastName': 'Yeldan', 'Affiliation': 'Istanbul University-Cerrahpasa, Faculty of Health Sciences, Division of Physiotherapy and Rehabilitation, Bakırköy, Istanbul, Turkey. Electronic address: ipekyeldan@gmail.com.'}, {'ForeName': 'Gulfer', 'Initials': 'G', 'LastName': 'Okumus', 'Affiliation': 'Istanbul University, Istanbul Faculty of Medicine, Department of Chest Disease, Istanbul, Turkey. Electronic address: gulferokumus@yahoo.com.'}]",Heart & lung : the journal of critical care,['10.1016/j.hrtlng.2020.01.014']
998,29908319,Association of free vitamin D 3  concentrations and asthma treatment failures in the VIDA Trial.,"BACKGROUND


Use of vitamin D 3  serum concentrations as a biomarker of vitamin D status is questionable because of variation in vitamin D binding protein.
OBJECTIVE


To determine associations between free vitamin D3 concentrations and rates of treatment failure and exacerbations in patients with asthma participating in the Vitamin D Add-on Therapy Enhances Corticosteroid Responsiveness in Asthma (VIDA) trial.
METHODS


Free concentrations were directly measured by enzyme-linked immunosorbent assay and stratified into low, medium, and high groups: less than 5pg/mL (n = 65), 5 to 9pg/mL (n = 84), and greater than 9pg/mL (n = 48) after 12 weeks of supplementation with oral vitamin D3 and associated with outcomes.
RESULTS


Outcomes did not associate with free concentrations: overall treatment failure rates were 0.60 (95% confidence interval [CI] 0.46-0.78), 0.53 (95%CI 0.40- 0.70), and 0.69 (95%CI 0.54-0.90)/person-year (P = .51), respectively; overall exacerbation rates were 0.28 (95%CI 0.17-0.48), 0.15 (95%CI 0.08-0.30) and 0.42 (95%CI 0.27-0.66)/person-year (P = .22). Mean (standard deviation) baseline free concentrations were lower in non-Hispanic blacks and Hispanics compared with non-Hispanic whites: 4.10 (1.33) and 4.38 (1.11) pg/mL vs 5.16 (1.65) pg/ml, (P < .001 and P = 0.038), respectively. Mean (standard deviation) baseline free concentrations differed between females and males: 4.57 (1.58) and 5.08 (1.41) (P = .026); and between non-overweight (body mass index [BMI] < 25) and overweight (BMI > 25): 5.45 (1.86) vs 4.54 (1.39) (P < .001). The free fraction differed by race and sex but not by BMI.
CONCLUSION


The use of free concentrations was inferior to total concentrations as a biomarker of efficacy of vitamin D 3  supplementation in VIDA trial participants. Future studies of vitamin D status in patients with asthma should measure both free and total concentrations to better understand which marker of vitamin D function is most informative.",2018,The use of free concentrations was inferior to total concentrations as a biomarker of efficacy of vitamin D 3  supplementation in VIDA trial participants.,"['patients with asthma', 'patients with asthma participating in the Vitamin D Add-on Therapy Enhances Corticosteroid Responsiveness in Asthma (VIDA) trial', 'VIDA trial participants']",['supplementation with oral vitamin D3'],"['Mean (standard deviation) baseline free concentrations', 'overall exacerbation rates', 'free concentrations: overall treatment failure rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0162643'}]",,0.371862,The use of free concentrations was inferior to total concentrations as a biomarker of efficacy of vitamin D 3  supplementation in VIDA trial participants.,"[{'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Lima', 'Affiliation': ""Nemours Children's Health System, Jacksonville, Florida. Electronic address: jlima@nemours.org.""}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Tonya S', 'Initials': 'TS', 'LastName': 'King', 'Affiliation': 'Penn State University, Hershey, Pennsylvania.'}, {'ForeName': 'Jason E', 'Initials': 'JE', 'LastName': 'Lang', 'Affiliation': 'Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Victor E', 'Initials': 'VE', 'LastName': 'Ortega', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Peters', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Loren C', 'Initials': 'LC', 'LastName': 'Denlinger', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Israel', 'Affiliation': ""Brigham & Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Sorkness', 'Affiliation': ""Brigham & Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Wechsler', 'Affiliation': 'National Jewish Health, Denver, Colorado.'}, {'ForeName': 'Sally E', 'Initials': 'SE', 'LastName': 'Wenzel', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'Smith', 'Affiliation': 'Northwestern University, Chicago, Illinois.'}]","Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology",['10.1016/j.anai.2018.06.001']
999,29300387,"Patient understanding of, satisfaction with, and perceived utility of whole-genome sequencing: findings from the MedSeq Project.","PURPOSE


To examine patients' experiences with clinical use of whole-genome sequencing (WGS).
METHODS


A randomized trial compared primary care and cardiology patients receiving WGS and family health history (FH) information or FH information alone. 202 patients were surveyed before (BL) and up to 6 months after disclosure of results (6M).
RESULTS


Patients (mean age = 55 years; 50% female; 81% college graduates) reported low levels of decisional regret (mean: 7.1/100) and high satisfaction with physicians' disclosure of results (median: 29/30). Compared with the FH-only arm, patients receiving WGS results were more likely to report learning accurate disease risk information (odds ratio = 7.45) and findings influential for medical treatment (odds ratio = 2.39). Sessions where WGS results were disclosed took longer (30 vs. 15 minutes), particularly for primary care patients. Patients' expected utility of sequencing at BL was higher than perceived utility at 6M in several domains, including impacting medical decision making (87% vs. 54%) and influencing medication choice (73% vs. 32%).
CONCLUSION


Patients were satisfied with their physicians' communication of WGS results and perceived them as medically useful. Discrepancies in expected versus perceived utility of WGS results suggest a need to temper patients' expectations about its potential benefits.",2018,"Compared with the FH-only arm, patients receiving WGS results were more likely to report learning accurate disease risk information (odds ratio = 7.45) and findings influential for medical treatment (odds ratio = 2.39).","['primary care and cardiology patients receiving WGS and family health history (FH) information or FH information alone', '202 patients were surveyed before (BL) and up to 6 months after disclosure of results (6M', 'Patients (mean age = 55 years; 50% female; 81% college graduates']",[],"['low levels of decisional regret', 'medication choice', 'report learning accurate disease risk information', 'utility of sequencing at BL']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0241889', 'cui_str': 'Family Medical History'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0588053', 'cui_str': 'Graduate (person)'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0080101', 'cui_str': 'Regret'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0443131', 'cui_str': 'Accurate (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",202.0,0.0289607,"Compared with the FH-only arm, patients receiving WGS results were more likely to report learning accurate disease risk information (odds ratio = 7.45) and findings influential for medical treatment (odds ratio = 2.39).","[{'ForeName': 'J Scott', 'Initials': 'JS', 'LastName': 'Roberts', 'Affiliation': 'Department of Health Behavior and Health Education, University of Michigan School of Public Health, Ann Arbor, Michigan, USA. jscottr@umich.edu.'}, {'ForeName': 'Jill O', 'Initials': 'JO', 'LastName': 'Robinson', 'Affiliation': 'Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Pamela M', 'Initials': 'PM', 'LastName': 'Diamond', 'Affiliation': 'Division of Health Promotion & Behavioral Sciences, University of Texas Houston School of Public Health, Houston, Texas, USA.'}, {'ForeName': 'Archana', 'Initials': 'A', 'LastName': 'Bharadwaj', 'Affiliation': 'Department of Health Behavior and Health Education, University of Michigan School of Public Health, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Kurt D', 'Initials': 'KD', 'LastName': 'Christensen', 'Affiliation': ""Division of Genetics, Department of Medicine, Brigham and Women's, Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Kaitlyn B', 'Initials': 'KB', 'LastName': 'Lee', 'Affiliation': 'Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Green', 'Affiliation': ""Division of Genetics, Department of Medicine, Brigham and Women's, Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'McGuire', 'Affiliation': 'Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Genetics in medicine : official journal of the American College of Medical Genetics,['10.1038/gim.2017.223']
1000,31983237,Topical proparacaine eye drops to improve the experience of patients undergoing intravitreal injections: A randomized controlled trial.,"PURPOSE


We sought to evaluate whether additional topical anesthetic, specifically proparacaine 0.5%, improved patient experience with intravitreal injections without hindering antisepsis.
METHODS


A prospective, randomized controlled trial was conducted including 36 eyes of 36 patients undergoing intravitreal injections. Patients were randomized to treatment with additional topical proparacaine 0.5% versus control after undergoing informed consent. All patients prior to intravitreal injection underwent conjunctival culture after one drop of topical proparacaine 0.5% was placed. Half of patients then received an additional drop of proparacaine and then underwent a second conjunctival culture. The other half of patients had a drop of povidone iodine and then a second conjunctival culture. Intravitreal injection followed conjunctival cultures. To evaluate their experience, patients were provided with a survey.
RESULTS


In total, 36 patients were enrolled in the study. Three of 36 (8.3%) patients had positive conjunctival cultures after proparacaine eye drops alone. One of 17 (5.8%) patients had a positive conjunctival culture after a second drop of proparacaine. One of 19 (5.3%) patients had a positive culture after proparacaine and povidone iodine. By noninferiority analysis, proparacaine was inferior to povidone iodine ( p  = .28). Patient experience surveys did not differ between groups.
CONCLUSION


Patient perception did not significantly differ whether or not additional proparacaine drops were used prior to intravitreal injection in a randomized controlled trial. While proparacaine has some antiseptic properties, these were found to be inferior to those of povidone iodine. Therefore, while povidone iodine is essential for antisepsis, additional proparacaine drops should not interfere with antisepsis.",2020,Three of 36 (8.3%) patients had positive conjunctival cultures after proparacaine eye drops alone.,"['36 patients were enrolled in the study', '36 eyes of 36 patients undergoing intravitreal injections', 'patients undergoing intravitreal injections']","['additional topical proparacaine', 'proparacaine', 'intravitreal injections without hindering antisepsis', 'proparacaine and povidone iodine', 'Intravitreal injection followed conjunctival cultures', 'Topical proparacaine', 'topical proparacaine', 'povidone iodine']","['positive conjunctival cultures', 'positive conjunctival culture']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0072510', 'cui_str': 'proxymetacaine'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C0003424', 'cui_str': 'Antisepsis'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0220814', 'cui_str': 'culture'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0220814', 'cui_str': 'culture'}]",36.0,0.12142,Three of 36 (8.3%) patients had positive conjunctival cultures after proparacaine eye drops alone.,"[{'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Reynolds', 'Affiliation': 'Department of Ophthalmology, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Mercill', 'Affiliation': 'Department of Nursing, Mayo Clinic and Mayo Foundation, Rochester, MN, USA.'}, {'ForeName': 'Amber L', 'Initials': 'AL', 'LastName': 'Wirkus', 'Affiliation': 'Department of Nursing, Mayo Clinic and Mayo Foundation, Rochester, MN, USA.'}, {'ForeName': 'Kerryl', 'Initials': 'K', 'LastName': 'Greenwood Quaintance', 'Affiliation': 'Department of Laboratory Medicine, Mayo Clinic and Mayo Foundation, Rochester, MN, USA.'}, {'ForeName': 'Jose S', 'Initials': 'JS', 'LastName': 'Pulido', 'Affiliation': 'Department of Ophthalmology, Mayo Clinic and Mayo Foundation, Rochester, MN, USA.'}]",European journal of ophthalmology,['10.1177/1120672120902026']
1001,29659918,Association of dairy intake with weight change in adolescents undergoing obesity treatment.,"BACKGROUND


The role of dairy products in obesity treatment for adolescents is unclear. The study purpose was to assess the association between dairy intake and changes in BMI z-score (zBMI) during adolescent obesity treatment.
METHODS


Observational study nested within a randomized control trial. Linear mixed-effects regression models were adjusted for important non-lifestyle factors then further adjusted for dietary and physical activity variables. In total, 91 adolescents were studied.
RESULTS


Each serving of total dairy (β = -0.0054, P < 0.01), unflavored milk (β = -0.012, P < 0.01), reduced fat (β = -0.0078, P < 0.05), and low fat/fat-free products (β = -0.0149, P < 0.01) was associated with a decrease in zBMI over 12 months. These associations were no longer significant after adjustment for other dietary and physical activity factors. Sugar-sweetened beverage intake was inversely associated with intake of total dairy (β = -0.186, P = 0.001), unflavored milk (β = -0.115, P = 0.003) and low fat/fat-free dairy (β = -0.125, P = 0.001).
CONCLUSIONS


Intakes of total dairy, unflavored milk, reduced fat dairy and low fat/fat-free dairy products are associated with improved obesity treatment outcomes among adolescents. This could be due to co-occurring healthy lifestyle behaviors or to replacement of other food and beverages associated with obesity, such as sugar-sweetened beverages, by dairy products.",2019,"Sugar-sweetened beverage intake was inversely associated with intake of total dairy (β = -0.186, P = 0.001), unflavored milk (β = -0.115, P = 0.003) and low fat/fat-free dairy (β = -0.125, P = 0.001).
","['adolescents undergoing obesity treatment', 'adolescent obesity treatment', '91 adolescents were studied']",[],"['zBMI', 'BMI z-score (zBMI', 'intake of total dairy', 'unflavored milk']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}, {'cui': 'C4317171', 'cui_str': 'Adolescent Obesity'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0026131', 'cui_str': 'Milk'}]",91.0,0.0488097,"Sugar-sweetened beverage intake was inversely associated with intake of total dairy (β = -0.186, P = 0.001), unflavored milk (β = -0.115, P = 0.003) and low fat/fat-free dairy (β = -0.125, P = 0.001).
","[{'ForeName': 'Brian H', 'Initials': 'BH', 'LastName': 'Wrotniak', 'Affiliation': 'The Children Hospital of Philadelphia, Philadelphia, PA, USA.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Georger', 'Affiliation': ""D'Youville College, 320 Porter Avenue, Buffalo, NY, USA.""}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Hill', 'Affiliation': 'The Children Hospital of Philadelphia, Philadelphia, PA, USA.'}, {'ForeName': 'Babette S', 'Initials': 'BS', 'LastName': 'Zemel', 'Affiliation': 'The Children Hospital of Philadelphia, Philadelphia, PA, USA.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Stettler', 'Affiliation': 'The Children Hospital of Philadelphia, Philadelphia, PA, USA.'}]","Journal of public health (Oxford, England)",['10.1093/pubmed/fdy064']
1002,31983494,Oral Ondansetron to Reduce Vomiting in Children Receiving Intranasal Fentanyl and Inhaled Nitrous Oxide for Procedural Sedation and Analgesia: A Randomized Controlled Trial.,"STUDY OBJECTIVE


Intranasal fentanyl and inhaled nitrous oxide are increasingly combined to provide procedural sedation and analgesia in the pediatric emergency setting. This regimen is attractive because of its nonparenteral administration, but is associated with a higher incidence of vomiting than nitrous oxide alone. We seek to assess whether prophylactic oral ondansetron use could reduce the incidence of vomiting associated with intranasal fentanyl and nitrous oxide for procedural sedation compared with placebo.
METHODS


This was a double-blind, randomized controlled trial of oral ondansetron versus placebo conducted at a single tertiary care pediatric emergency department. Children aged 3 to 18 years with planned sedation with intranasal fentanyl and nitrous oxide were randomized to receive oral ondansetron or placebo 30 to 60 minutes before nitrous oxide administration. The primary outcome was early vomiting associated with procedural sedation, defined as occurring during or up to 1 hour after nitrous oxide administration. Secondary outcomes included vomiting 1 to 24 hours after procedural sedation, procedural sedation duration, adverse events, and quality of sedation across the 2 groups.
RESULTS


We recruited 442 participants and 436 were included for analysis. There was no significant difference in the primary outcome, early vomiting associated with procedural sedation, between the groups: ondansetron 12% versus placebo 16%, with a difference in proportions of -4.6% (95% confidence interval -11% to 2.0%; P=.18). Most sedations were reported as optimal by treating clinicians (91%). Only 2 minor adverse events occurred, both in the placebo group.
CONCLUSION


Oral ondansetron does not significantly reduce vomiting during or shortly after procedural sedation with combined intranasal fentanyl and inhaled nitrous oxide.",2020,Oral ondansetron does not significantly reduce vomiting during or shortly after procedural sedation with combined intranasal fentanyl and inhaled nitrous oxide.,"['442 participants and 436 were included for analysis', 'Children aged 3 to 18 years with planned sedation with intranasal fentanyl and nitrous oxide', 'single tertiary care pediatric emergency department', 'Children Receiving Intranasal Fentanyl and Inhaled Nitrous Oxide for Procedural Sedation and Analgesia']","['fentanyl and inhaled nitrous oxide', 'oral ondansetron or placebo', 'ondansetron', 'Oral ondansetron', 'placebo', 'oral ondansetron', 'Oral Ondansetron', 'inhaled nitrous oxide']","['Vomiting', 'incidence of vomiting', 'vomiting 1 to 24 hours after procedural sedation, procedural sedation duration, adverse events, and quality of sedation across the 2 groups', 'early vomiting associated with procedural sedation', 'vomiting', 'adverse events', 'early vomiting associated with procedural sedation, defined as occurring during or up to 1 hour after nitrous oxide administration']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]",442.0,0.574584,Oral ondansetron does not significantly reduce vomiting during or shortly after procedural sedation with combined intranasal fentanyl and inhaled nitrous oxide.,"[{'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Fauteux-Lamarre', 'Affiliation': ""Emergency Department, The Royal Children's Hospital, Melbourne, Victoria, Australia; Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'McCarthy', 'Affiliation': ""Emergency Department, The Royal Children's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Nuala', 'Initials': 'N', 'LastName': 'Quinn', 'Affiliation': ""Emergency Department, The Royal Children's Hospital, Melbourne, Victoria, Australia; Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Davidson', 'Affiliation': ""Department of Anaesthesia and Pain Management, The Royal Children's Hospital, Melbourne, Victoria, Australia; Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia; Melbourne Children's Trials Centre, Melbourne, Victoria, Australia.""}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Legge', 'Affiliation': ""Department of Pharmacy, The Royal Children's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Katherine J', 'Initials': 'KJ', 'LastName': 'Lee', 'Affiliation': ""Murdoch Children's Research Institute, Melbourne, Victoria, Australia; Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia; Melbourne Children's Trials Centre, Melbourne, Victoria, Australia.""}, {'ForeName': 'Greta M', 'Initials': 'GM', 'LastName': 'Palmer', 'Affiliation': ""Department of Anaesthesia and Pain Management, The Royal Children's Hospital, Melbourne, Victoria, Australia; Murdoch Children's Research Institute, Melbourne, Victoria, Australia; Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.""}, {'ForeName': 'Franz E', 'Initials': 'FE', 'LastName': 'Babl', 'Affiliation': ""Emergency Department, The Royal Children's Hospital, Melbourne, Victoria, Australia; Murdoch Children's Research Institute, Melbourne, Victoria, Australia; Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia. Electronic address: franz.babl@rch.org.au.""}, {'ForeName': 'Sandy M', 'Initials': 'SM', 'LastName': 'Hopper', 'Affiliation': ""Emergency Department, The Royal Children's Hospital, Melbourne, Victoria, Australia; Murdoch Children's Research Institute, Melbourne, Victoria, Australia; Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.""}]",Annals of emergency medicine,['10.1016/j.annemergmed.2019.11.019']
1003,31982219,"Is it feasible ""scoop and run while playing"" resuscitation on a rescue water craft? A randomized simulation study with lifeguards.","OBJECTIVE


Response time is a predictive factor for survival of drowning victims and lifesaving. Rescue Water Craft (RWC) are lifeboats very common in lifeguards operations. The aim of this study was to analyze the feasibility of providing effective mouth-to-mouth ventilations and/or cardiopulmonary resuscitation (CPR) on the RWC while sailing at different speeds.
METHOD


A quasi-experimental cross-over block design was used to test during one minute efforts the effectiveness of Mouth to Mouth ventilation (MM-only) and CRP, at the beach and sailing at two diferents speeds 5 knots(kn) and 10 kn with calm sea. Quality CPR reference were 2015 ERC guidelines.
RESULTS


The data obtained from 13 lifeguards were included, that means that 78 resuscitation test were completed. The MM-only performance skills reached 69.7% ± 40.4 for 5 kn and 60.0% ± 41.8 for 10 kn (p = .59). For full CPR, performance was 74.4% ± 24.2 and 68.5% ± 23.9 respectively. Quality of MM and CPR decreased, not significantly, while sailing at 5 kn and 10 kn [(Q-MM; 5 kn: 59.9% ± 37.8 vs. 10 kn: 43.2% ± 41.4, p = .42)(Q-CPR; 5 kn: 64.8% ± 21.2 and 10 kn: 60.6% ± 21.0, p = .44)]. MM-only and CC variables were significantly worse on RJS when compared with resuscitation at the beach (p < .05). A trend for better results by lifeguards previously training on RJS was observed.
CONCLUSIONS


Resuscitation techniques on board of a RWC are feasible and therefore they could be an option for lifeguards when their training, sea conditions, distance and the victim's characteristics allow it. CPR maneuvers may be highly effective at 10 kn, both for MM-only and CPR, however, the quality of the ventilations dramatically worsen with increasing speed.",2020,"For full CPR, performance was 74.4% ± 24.2 and 68.5% ± 23.9 respectively.","['13 lifeguards were included, that means that 78 resuscitation test were completed']","['mouth ventilations and/or cardiopulmonary resuscitation (CPR', 'Mouth to Mouth ventilation (MM-only) and CRP, at the beach and sailing at two diferents speeds 5 knots(kn) and 10 kn with calm sea', 'Rescue Water Craft (RWC']","['MM-only performance skills', 'Quality of MM and CPR', 'Quality CPR reference']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0331781', 'cui_str': 'Beach (environment)'}, {'cui': 'C0522727', 'cui_str': 'Sailing'}, {'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C0150157', 'cui_str': 'Calming'}, {'cui': 'C0036493', 'cui_str': 'Sea (environment)'}, {'cui': 'C0043047', 'cui_str': 'Water'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}]",,0.0407647,"For full CPR, performance was 74.4% ± 24.2 and 68.5% ± 23.9 respectively.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Barcala-Furelos', 'Affiliation': 'REMOSS Research Group, International Drowning Research Alliance-IDRA (Spain), Faculty of Education and Sport Sciences, Universidade de Vigo, Spain; CLINURSID Research Group, Psychiatry, Radiology, Public Health, Nursing and Medicine Departament, Universidade de Santiago de Compostela, Santiago de Compostela, Galicia, Spain. Electronic address: roberto.barcala@uvigo.es.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Abelairas-Gomez', 'Affiliation': 'CLINURSID Research Group, Psychiatry, Radiology, Public Health, Nursing and Medicine Departament, Universidade de Santiago de Compostela, Santiago de Compostela, Galicia, Spain; Faculty of Education, Universidade de Santiago de Compostela, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Aranda-García', 'Affiliation': ""GRAFiS Research Group, Institut Nacional d'Educació Física de Catalunya, Universitat de Barcelona (UB), Barcelona, Spain.""}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Lorenzo-Martínez', 'Affiliation': 'REMOSS Research Group, International Drowning Research Alliance-IDRA (Spain), Faculty of Education and Sport Sciences, Universidade de Vigo, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Martínez-Isasi', 'Affiliation': 'CLINURSID Research Group, Psychiatry, Radiology, Public Health, Nursing and Medicine Departament, Universidade de Santiago de Compostela, Santiago de Compostela, Galicia, Spain.'}, {'ForeName': 'Carlota', 'Initials': 'C', 'LastName': 'Durán-Álvarez', 'Affiliation': 'Noia Health Center, SERGAS, Noia, A Coruña, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Palacios-Aguilar', 'Affiliation': 'Faculty of Sport Sciences and Physical Activity, Universidade da Coruña, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Rodríguez-Núñez', 'Affiliation': 'CLINURSID Research Group, Psychiatry, Radiology, Public Health, Nursing and Medicine Departament, Universidade de Santiago de Compostela, Santiago de Compostela, Galicia, Spain.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.10.045']
1004,31980242,"A prospective, randomized study comparing ultrasound versus fluoroscopic guided femoral arterial access in noncardiac vascular patients.","OBJECTIVE


The aim of our prospective, single-center, randomized study was to compare the procedural outcomes and complication rates of ultrasound (US)-guided common femoral artery (CFA) access to fluoroscopic guidance in noncardiac procedures.
METHODS


A total of 635 patients undergoing femoral access for noncardiac diagnostic or interventional procedures were randomized 1:1 to receive either fluoroscopic or US-guided access. The primary end point of the study was successful CFA cannulation. Secondary end points included the first-pass success rate, time to sheath insertion, and accidental venipunctures rate. Both short (24 hours) and midterm (30-90 days postprocedure) access complications were assessed by practitioners blinded to patient randomization.
RESULTS


Successful CFA cannulation occurred in 93% of US-guided procedures compared with 86% of fluoroscopy-guided access (P = .002). US guidance was associated with increased rates of first-attempt success (74% vs 42%; P < .001), fewer inadvertent venipunctures (2% vs 10 %; P < .001), and decreased median time to cannulation (80 vs 100 seconds; P < .001) compared with fluoroscopy. Rates of complications did not differ at 24 hours (1% vs 1%; P = .99) or 30 to 90 days (2% vs 4%; P = .15) in fluoroscopy vs US-guided access. When access was performed by vascular surgery trainees (residents and fellows), US guidance retained superior rates of successful CFA cannulation compared to fluoroscopy guided access (n = 298; 96% vs 89%; P = .03). Trainees' time to achieve CFA cannulation was similar to attendings' when using US guidance (median, 85 vs 77 seconds; P = .14); however, with fluoroscopy, trainees' times were significantly longer than those of attendings (137 vs 86 seconds; P = .001).
CONCLUSIONS


In comparison to fluoroscopy, US-guided CFA cannulation had a higher rate of success, faster cannulation, and fewer venipunctures in the absence of increased complications.",2020,"US guidance was associated with increased rates of first-attempt success (74% vs 42%; P < .001), fewer inadvertent venipunctures (2% vs 10 %; P < .001), and decreased median time to cannulation (80 vs 100 seconds; P < .001) compared with fluoroscopy.","['noncardiac vascular patients', '635 patients undergoing femoral access for noncardiac diagnostic or interventional procedures']","['ultrasound versus fluoroscopic guided femoral arterial access', 'fluoroscopic or US-guided access', 'fluoroscopy, US-guided CFA cannulation', 'ultrasound (US)-guided common femoral artery (CFA']","['inadvertent venipunctures', 'procedural outcomes and complication rates', 'first-pass success rate, time to sheath insertion, and accidental venipunctures rate', 'access complications', 'successful CFA cannulation', 'Successful CFA cannulation', 'median time to cannulation', 'Rates of complications', 'rates of first-attempt success', ""Trainees' time to achieve CFA cannulation"", 'rate of success, faster cannulation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0447105', 'cui_str': 'Common femoral artery (body structure)'}]","[{'cui': 'C0600406', 'cui_str': 'Venipuncture (procedure)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0444693', 'cui_str': 'First pass (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0521129', 'cui_str': 'Accidental (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]",635.0,0.150195,"US guidance was associated with increased rates of first-attempt success (74% vs 42%; P < .001), fewer inadvertent venipunctures (2% vs 10 %; P < .001), and decreased median time to cannulation (80 vs 100 seconds; P < .001) compared with fluoroscopy.","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Stone', 'Affiliation': 'Division of Vascular Surgery, Vanderbilt University, Nashville, Tenn; Division of Vascular Surgery, West Virginia University (Charleston Division), Charleston, WV. Electronic address: pstone0627@yahoo.com.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Campbell', 'Affiliation': 'Division of Vascular Surgery, West Virginia University (Charleston Division), Charleston, WV.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Thompson', 'Affiliation': 'Charleston Area Medical Center Health Education and Research Institute, Charleston, WV.'}, {'ForeName': 'Jerri', 'Initials': 'J', 'LastName': 'Walker', 'Affiliation': 'Charleston Area Medical Center Health Education and Research Institute, Charleston, WV.'}]",Journal of vascular surgery,['10.1016/j.jvs.2019.09.051']
1005,31980342,Experiential negative symptoms are more predictive of real-life functional outcome than expressive negative symptoms in clinical high-risk states.,"BACKGROUND


Negative symptoms are key features of psychosis-spectrum disorders linked to psychosis development and functional impairments. This study investigated the predictive strength of negative symptoms domains on multiple aspects of real-life functional outcome in individuals at clinical high-risk (CHR) for psychosis.
METHODS


A total of 146 UHR individuals were enrolled in a randomized, clinical trial (RCT), with this being analyses secondary to the RCT. The participants were assessed at baseline with the Scale for the Assessment of Negative Symptoms (SANS) encompassing the four domains of affect, alogia, avolition, and anhedonia. Functioning measures, encompassing overall-, social-, and role functioning, self-report social functioning, and quality of life, were obtained at 12-month follow-up. Regression analyses elucidated on the relationship between the four negative symptom domains and functional outcomes.
RESULTS


Anhedonia and avolition were the aspects of negative symptoms most predictive of real-life functioning at 12-month follow-up explaining 7-20% of the variance on the outcome measures. Alogia was predictive of social functioning. These findings were maintained when controlling for the effect of neurocognition, antipsychotic medication, and depressive symptoms.
DISCUSSION


Our findings show experiential negative symptoms to predict multiple areas of real-life functioning and quality of life, while expressive negative symptoms exert a modest influence on the functional prognosis of CHR individuals. Experiential negative symptoms may therefore constitute an important treatment target in intervention approaches aimed at enhancing the functional outcome of CHR individuals.",2020,"RESULTS


Anhedonia and avolition were the aspects of negative symptoms most predictive of real-life functioning at 12-month follow-up explaining 7-20% of the variance on the outcome measures.","['146 UHR individuals', 'individuals at clinical high-risk (CHR) for psychosis']",[],"['alogia, avolition, and anhedonia', 'Functioning measures, encompassing overall-, social-, and role functioning, self-report social functioning, and quality of life']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}]",[],"[{'cui': 'C0003537', 'cui_str': 'Anepia'}, {'cui': 'C3495892', 'cui_str': 'Avolition'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0034380'}]",146.0,0.0758566,"RESULTS


Anhedonia and avolition were the aspects of negative symptoms most predictive of real-life functioning at 12-month follow-up explaining 7-20% of the variance on the outcome measures.","[{'ForeName': 'Louise Birkedal', 'Initials': 'LB', 'LastName': 'Glenthøj', 'Affiliation': 'Copenhagen Research Centre for Mental Health (CORE), Copenhagen University Hospital, DK-2900 Hellerup, Denmark; Centre for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS, DK-2600 Glostrup, Denmark. Electronic address: louise.birkedal.glenthoej@regionh.dk.'}, {'ForeName': 'Tina Dam', 'Initials': 'TD', 'LastName': 'Kristensen', 'Affiliation': 'Copenhagen Research Centre for Mental Health (CORE), Copenhagen University Hospital, DK-2900 Hellerup, Denmark; Centre for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS, DK-2600 Glostrup, Denmark.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Wenneberg', 'Affiliation': 'Copenhagen Research Centre for Mental Health (CORE), Copenhagen University Hospital, DK-2900 Hellerup, Denmark; Centre for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS, DK-2600 Glostrup, Denmark.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Hjorthøj', 'Affiliation': 'Copenhagen Research Centre for Mental Health (CORE), Copenhagen University Hospital, DK-2900 Hellerup, Denmark; University of Copenhagen, Department of Public Health, Section of Epidemiology, Denmark.'}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Nordentoft', 'Affiliation': 'Copenhagen Research Centre for Mental Health (CORE), Copenhagen University Hospital, DK-2900 Hellerup, Denmark; Centre for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS, DK-2600 Glostrup, Denmark.'}]",Schizophrenia research,['10.1016/j.schres.2020.01.012']
1006,31983113,Analyses of clinical efficacy of ultrasound-guided radiofrequency ablation in liver cancer adjacent to the gallbladder and its prognosis.,"PURPOSE


To explore the clinical efficacy of ultrasound-guided radiofrequency ablation (RFA) in liver cancer adjacent to the gallbladder and to analyze its prognosis.
METHODS


80 patients with liver cancer adjacent to the gallbladder, who were admitted to our hospital from January 2015 to April 2018, were enrolled and divided into the Observation group (n=40) and the Control group (n=40). All of the patients underwent cholecystectomy and lymph node dissection combined with postoperative chemotherapy. RFA was performed in the Observation group, while radical cholecystectomy and radical hepatectomy were conducted simultaneously in the Control group. Follow up was by telephone, and tumor-associated factor levels, liver function and cellular and humoral immune function-related indicators at 1 month after intervention, tumor size before and after treatment and cases of normal alpha-fetoprotein (AFP) level and tumor disappearance after treatment were compared between the two groups. The complications rates during treatment (increase in transaminases, elevation of bilirubin, intratumoral hemorrhage, bile duct injury and gastrointestinal perforation), clinical efficacy and 1-year survival in the two groups were statistically analyzed.
RESULTS


At 1 month after intervention, the Observation group had substantially lower levels of tumor-associated factors AFP, carbohydrate antigen 19-9 (CA19-9) and carcinoembryonic antigen (CEA) (p<0.05), obviously lower levels of liver function indicators aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin (TBIL), indirect bilirubin (IBIL) and direct bilirubin (DBIL) (p<0.05), but distinctly higher levels of immunoglobulin G (IgG), IgA and IgM, cluster of differentiation 4+ (CD4+), CD8+ and CD4+/CD8+ (p<0.05) than the Control group. Before and after treatment, the tumor size in the Observation group was smaller than in the Control group (p<0.05). The Observation group exhibited notably more cases of normal APF level and tumor disappearance after treatment (p<0.05), markedly lower incidence rates of increase in transaminases, elevation of bilirubin, intratumoral hemorrhage, bile duct injury and gastrointestinal perforation during treatment (p<0.05) than the Control group. Additionally, the rate of stable disease (SD) was notably higher and the 1-year survival rate was higher in the Observation group than in the Control group (p<0.05).
CONCLUSIONS


RFA for liver cancer adjacent to the gallbladder can effectively lower the levels of tumor markers, improve liver function and enhance immunity, with a few operative complications and high efficacy, so it has a positive impact in prolonging the survival of patients.",2019,"At 1 month after intervention, the Observation group had substantially lower levels of tumor-associated factors AFP, carbohydrate antigen 19-9 (CA19-9) and carcinoembryonic antigen (CEA) (p<0.05), obviously lower levels of liver function indicators aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin (TBIL), indirect bilirubin (IBIL) and direct bilirubin (DBIL) (p<0.05), but distinctly higher levels of immunoglobulin G (IgG), IgA and IgM, cluster of differentiation 4+ (CD4+), CD8+ and CD4+/CD8+ (p<0.05) than the Control group.","['80 patients with liver cancer adjacent to the gallbladder, who were admitted to our hospital from January 2015 to April 2018, were enrolled and divided into the Observation group (n=40) and the Control group (n=40']","['RFA', 'radical cholecystectomy and radical hepatectomy', 'cholecystectomy and lymph node dissection combined with postoperative chemotherapy', 'ultrasound-guided radiofrequency ablation (RFA', 'ultrasound-guided radiofrequency ablation']","['lower levels of tumor-associated factors AFP, carbohydrate antigen 19-9 (CA19-9) and carcinoembryonic antigen (CEA) (p<0.05), obviously lower levels of liver function indicators aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin (TBIL), indirect bilirubin (IBIL) and direct bilirubin (DBIL', 'factor levels, liver function and cellular and humoral immune function-related indicators', 'tumor size', 'normal APF level and tumor disappearance', 'complications rates', 'liver function and enhance immunity', 'transaminases, elevation of bilirubin, intratumoral hemorrhage, bile duct injury and gastrointestinal perforation', '1-year survival rate', 'rate of stable disease (SD', 'levels of immunoglobulin G (IgG), IgA and IgM, cluster of differentiation 4+ (CD4+), CD8+ and CD4+/CD8', 'normal alpha-fetoprotein (AFP) level and tumor disappearance', 'transaminases, elevation of bilirubin, intratumoral hemorrhage, bile duct injury and gastrointestinal perforation), clinical efficacy and 1-year survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0345904', 'cui_str': 'Cancer of Liver'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed (qualifier value)'}, {'cui': 'C0016976', 'cui_str': 'Gallbladder'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332286', 'cui_str': 'Into (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0242382', 'cui_str': 'Lymph Node Dissection'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1273551', 'cui_str': 'Postoperative chemotherapy'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0201551', 'cui_str': 'CA 199 measurement'}, {'cui': 'C0007082', 'cui_str': 'Antigens, CD66e'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0201913', 'cui_str': 'Bilirubin, total measurement (procedure)'}, {'cui': 'C0301719', 'cui_str': 'Indirect reacting bilirubin (substance)'}, {'cui': 'C0236556', 'cui_str': 'Direct reacting bilirubin (substance)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C3491832', 'cui_str': '(125I)APF'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0020964', 'cui_str': 'Immunity'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin IX alpha'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0434034', 'cui_str': 'Injury of bile duct (disorder)'}, {'cui': 'C1963976', 'cui_str': 'Gastrointestinal perforation (SMQ)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0202087', 'cui_str': 'Immunoglobulin G measurement (procedure)'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0020861', 'cui_str': 'IgM'}, {'cui': 'C0428521', 'cui_str': 'Alpha-fetoprotein level - finding'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",80.0,0.0254277,"At 1 month after intervention, the Observation group had substantially lower levels of tumor-associated factors AFP, carbohydrate antigen 19-9 (CA19-9) and carcinoembryonic antigen (CEA) (p<0.05), obviously lower levels of liver function indicators aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin (TBIL), indirect bilirubin (IBIL) and direct bilirubin (DBIL) (p<0.05), but distinctly higher levels of immunoglobulin G (IgG), IgA and IgM, cluster of differentiation 4+ (CD4+), CD8+ and CD4+/CD8+ (p<0.05) than the Control group.","[{'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': 'Department of Ultrasound, Hubei Maternal and Child Health Hospital, Wuhan 430070, China.'}, {'ForeName': 'Sha', 'Initials': 'S', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': ''}]",Journal of B.U.ON. : official journal of the Balkan Union of Oncology,[]
1007,31973558,Combining cataract surgery with 25-gauge high-speed pars plana vitrectomy: A prospective study.,"PURPOSE


To compare visual outcome and postoperative complications of combined 25-gauge pars plana vitrectomy and phacoemulsification with vitrectomy alone surgery in patients with epiretinal membrane and macular hole.
METHODS


A total of 110 eyes (73 eyes with epiretinal membrane and 37 eyes with macular hole) were enrolled in this prospective study. The eyes were divided into two groups: Group A included 55 eyes which underwent phacovitrectomy at the same time and Group B included 55 eyes which underwent vitrectomy alone. Follow-up visits were at 1, 3, and 6 months.
RESULTS


The best-corrected visual acuity correlation by analysis of variance measurement showed statistically non-significant differences between the two groups ( p  = 0.32). The post hoc analysis from baseline, 1°, 2°, and 3° follow-ups was not statistically significant ( p  > 0.05). The most common postoperative complication was cystoid macular edema that has been detected in 11 patients (10%) (seven eyes in Group A and four eyes in Group B): 2 patients (1.8%) developed a chronic macular edema. Intraocular hypertension occurred in five eyes (4.5%) (three in Group A and two in Group B). Four eyes (3.6%) underwent another surgical procedure for a persistent macular hole (two in Group A and two in Group B). The intraocular lens repositioning was performed one day after surgery in three eyes (2.7%) (Group A). The mean preoperative visual acuity was not different between the two groups ( p  = 0.80).
CONCLUSION


No significative differences between combined surgery and vitrectomy alone have been detected, in terms of postoperative complications and visual outcome.",2020,"No significative differences between combined surgery and vitrectomy alone have been detected, in terms of postoperative complications and visual outcome.","['patients with epiretinal membrane and macular hole', '110 eyes (73 eyes with epiretinal membrane and 37 eyes with macular hole']","['combined 25-gauge pars plana vitrectomy and phacoemulsification with vitrectomy alone surgery', 'cataract surgery with 25-gauge high-speed pars plana vitrectomy', 'phacovitrectomy at the same time and Group B included 55 eyes which underwent vitrectomy alone']","['postoperative complications and visual outcome', 'Intraocular hypertension', 'mean preoperative visual acuity', 'chronic macular edema', 'visual outcome and postoperative complications', 'cystoid macular edema', 'intraocular lens repositioning']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0339543', 'cui_str': 'Epiretinal Membrane'}, {'cui': 'C0024441', 'cui_str': 'Macular Holes'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0456564', 'cui_str': 'Gauges (qualifier value)'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach (procedure)'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C4521130', 'cui_str': 'Intraocular (intended site)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0271051', 'cui_str': 'Macular Edema'}, {'cui': 'C0024440', 'cui_str': 'Macular Dystrophy, Dominant Cystoid'}, {'cui': 'C0395541', 'cui_str': 'Repositioning of intraocular lens (procedure)'}]",110.0,0.0299599,"No significative differences between combined surgery and vitrectomy alone have been detected, in terms of postoperative complications and visual outcome.","[{'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Savastano', 'Affiliation': 'Department of Surgery and Translational Medicine, AOU Careggi, University of Florence, Florence, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Lenzetti', 'Affiliation': 'Department of Surgery and Translational Medicine, AOU Careggi, University of Florence, Florence, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Finocchio', 'Affiliation': 'Department of Surgery and Translational Medicine, AOU Careggi, University of Florence, Florence, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Bacherini', 'Affiliation': 'Department of Surgery and Translational Medicine, AOU Careggi, University of Florence, Florence, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Giansanti', 'Affiliation': 'Department of Surgery and Translational Medicine, AOU Careggi, University of Florence, Florence, Italy.'}, {'ForeName': 'Ruggero', 'Initials': 'R', 'LastName': 'Tartaro', 'Affiliation': 'Department of Surgery and Translational Medicine, AOU Careggi, University of Florence, Florence, Italy.'}, {'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'Piccirillo', 'Affiliation': ""Ospedale Civile Sant'Anna e San Sebastiano (AORN), Caserta, Italy.""}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Savastano', 'Affiliation': 'Centro Italiano Macula, Rome, Italy.'}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Virgili', 'Affiliation': 'Department of Surgery and Translational Medicine, AOU Careggi, University of Florence, Florence, Italy.'}, {'ForeName': 'Stanislao', 'Initials': 'S', 'LastName': 'Rizzo', 'Affiliation': 'Department of Surgery and Translational Medicine, AOU Careggi, University of Florence, Florence, Italy.'}]",European journal of ophthalmology,['10.1177/1120672120902030']
1008,31971832,Effects of functional training and 2 interdisciplinary interventions on maximal oxygen uptake and weight loss of women with obesity: a randomized clinical trial.,"Our aim was to analyze and compare functional training, interdisciplinary therapy, and interdisciplinary education on cardiorespiratory fitness (CF) and anthropometric characteristics of women with obesity. Forty-four women (age = 39.7 ± 5.9 years, body mass index (BMI) = 35.5 ± 2.8 kg/m 2 ) completed 30 weeks of intervention randomly assigned to 3 groups: functional training (FT) ( n  = 14), interdisciplinary therapy (IT) ( n  = 19), and interdisciplinary education (IE) ( n  = 11). The FT group participated in the training program (3/week), the IT group received the same training intervention plus nutrition (1/week) and psychology advice (1/week) and physical therapy (1/week). The IE group participated in interdisciplinary lectures on topics related to health promotion (1/month). CF (ergospirometry), anthropometry, and body composition (electrical bioimpedance) were measured pre-intervention (Pre) and post-intervention (Post). CF increased ( p  ≤ 0.05) significantly (Pre vs. Post) in the FT (7.5%) and IT (10.8%) groups, but not in the IE group (1.8%). Body mass (BM), BMI, relative fat mass, and waist circumference significantly ( p  ≤ 0.05) decreased (Pre vs. Post) in IT (-4.4%, -4.4%, -2.3%, and -5.1%, respectively). The IE group showed a significant decrease in BM (-3.7%), BMI (-3.7%), and waist circumference (-3.5%), whereas the FT group promoted significant decrease in waist circumference (-3.4%). In conclusion, functional training increased CF but only interdisciplinary interventions improved the anthropometric profile of women with obesity.  Novelty  Interdisciplinary therapy provided more comprehensive adaptations in women with obesity, including morphological variables and CF. Functional training increased CF but reduced only abdominal obesity. Interdisciplinary education provided benefits on morphological variables, but it does not increase CF.",2020,"IE showed a significant decrease in BM (-3.7%), in BMI (-3.7%) and in WC (-3.5%), whereas FT promoted significant decrease in WC (-3.4%).","['women with obesity', 'Forty-four women (age=39.7±5.9 years, BMI=35.5±2.8 kg/m²']","['functional training and two interdisciplinary interventions', 'functional training (FT), interdisciplinary therapy (IT) and interdisciplinary education (IE', 'same training intervention plus nutrition', 'Interdisciplinary therapy', 'Functional training']","['cardiorespiratory fitness', 'anthropometric profile of women with obesity', 'VO2max and weight loss', 'CF (ergospirometry), anthropometry and body composition (electrical bioimpedance', 'WC', 'BMI', 'Body mass (BM), body mass index (BMI), relative fat mass (FM) and waist circumference (WC', 'Novelty bullets •', 'cardiorespiratory fitness (CF) and anthropometric characteristics', 'CF', 'BM']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}]","[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0336699', 'cui_str': 'Bullet, device (physical object)'}]",44.0,0.0398489,"IE showed a significant decrease in BM (-3.7%), in BMI (-3.7%) and in WC (-3.5%), whereas FT promoted significant decrease in WC (-3.4%).","[{'ForeName': 'Cauê Vazquez', 'Initials': 'CV', 'LastName': 'La Scala Teixeira', 'Affiliation': 'Obesity Study Group, Interdisciplinary Laboratory of Metabolic Diseases, Federal University of São Paulo, Santos, SP 11045-301, Brazil.'}, {'ForeName': 'Danielle Arisa', 'Initials': 'DA', 'LastName': 'Caranti', 'Affiliation': 'Obesity Study Group, Interdisciplinary Laboratory of Metabolic Diseases, Federal University of São Paulo, Santos, SP 11045-301, Brazil.'}, {'ForeName': 'Lila Missae', 'Initials': 'LM', 'LastName': 'Oyama', 'Affiliation': 'Department of Physiology, Paulista School of Medicine, Federal University of São Paulo, SP 04023-900, Brazil.'}, {'ForeName': 'Ricardo da Costa', 'Initials': 'RDC', 'LastName': 'Padovani', 'Affiliation': 'Post Graduate Program of Interdisciplinary Health Sciences, Federal University of São Paulo, Santos, SP 11015-020, Brazil.'}, {'ForeName': 'Maria Gabriela Soria', 'Initials': 'MGS', 'LastName': 'Cuesta', 'Affiliation': 'Obesity Study Group, Interdisciplinary Laboratory of Metabolic Diseases, Federal University of São Paulo, Santos, SP 11045-301, Brazil.'}, {'ForeName': 'Amanda Dos Santos', 'Initials': 'ADS', 'LastName': 'Moraes', 'Affiliation': 'Obesity Study Group, Interdisciplinary Laboratory of Metabolic Diseases, Federal University of São Paulo, Santos, SP 11045-301, Brazil.'}, {'ForeName': 'Letícia Andrade', 'Initials': 'LA', 'LastName': 'Cerrone', 'Affiliation': 'Obesity Study Group, Interdisciplinary Laboratory of Metabolic Diseases, Federal University of São Paulo, Santos, SP 11045-301, Brazil.'}, {'ForeName': 'Luiz Henrique Lima', 'Initials': 'LHL', 'LastName': 'Affonso', 'Affiliation': 'Obesity Study Group, Interdisciplinary Laboratory of Metabolic Diseases, Federal University of São Paulo, Santos, SP 11045-301, Brazil.'}, {'ForeName': 'Silvandro Dos Santos', 'Initials': 'SDS', 'LastName': 'Gil', 'Affiliation': 'Obesity Study Group, Interdisciplinary Laboratory of Metabolic Diseases, Federal University of São Paulo, Santos, SP 11045-301, Brazil.'}, {'ForeName': 'Ronaldo V Thomatieli', 'Initials': 'RVT', 'LastName': 'Dos Santos', 'Affiliation': 'Department of Bioscience, Federal University of São Paulo, Santos, SP 11015-020, Brazil.'}, {'ForeName': 'Ricardo José', 'Initials': 'RJ', 'LastName': 'Gomes', 'Affiliation': 'Obesity Study Group, Interdisciplinary Laboratory of Metabolic Diseases, Federal University of São Paulo, Santos, SP 11045-301, Brazil.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0766']
1009,32406601,Goal achievement of HbA1c and LDL-cholesterol in a randomized trial comparing colesevelam with ezetimibe: GOAL-RCT.,"AIM


To compare the efficacy and safety of colesevelam and ezetimibe as second-line low density lipoprotein-cholesterol (LDL-c)-lowering options in type 2 diabetes (T2D).
MATERIALS AND METHODS


GOAL-RCT is a 24-week, open-label, randomized, pragmatic clinical trial. Subjects with T2D with uncontrolled HbA1c (7.1%-10%) and LDL-c (>2.0 mmol/L) were randomized 1:1 to colesevelam 3.75 g or ezetimibe 10 mg daily. The primary composite outcome was the proportion of participants achieving an LDL-c target of ≤2.0 mmol/L and HbA1c target of ≤7.0%. Intention to treat analysis was performed.
RESULTS


Two hundred subjects were enrolled: mean age 59 ± 10 years; mean HbA1c 8.0%; mean LDL-c 2.5 mmol/L; 97% on statin therapy. The primary composite outcome was achieved by similar proportions of participants with colesevelam (14.6%) and ezetimibe (10.5%) (P non-inferiority   < .001, P superiority  = .41). LDL-c reduction from baseline was less with colesevelam compared with ezetimibe (14.0% vs. 23.2%, P < .01), as was the proportion of subjects achieving an LDL-c target of ≤2.0 mmol/L (47.6% and 67.0%, respectively; P = .007). Mean HbA1c was reduced with colesevelam (-0.26 ± 0.10%), while no change was observed with ezetimibe (difference P = .06). Adverse events and discontinuation rates were higher for colesevelam (20.2% and 31.1%) compared with ezetimibe (7.2% and 6.2%), respectively.
CONCLUSIONS


Among subjects with T2D, the initiation of colesevelam or ezetimibe led to similar achievement of primary composite outcome (LDL-c and HbA1c within target), with ezetimibe recording a greater LDL-c reduction and better tolerability than colesevelam.",2020,"LDL-c reduction from baseline was less with colesevelam compared to ezetimibe (14.0% vs. 23.2%, p < 0.01), as was the proportion of subjects achieving LDL-c target ≤2.0 mmol/L (47.6% and 67.0%, respectively; p = 0.007).","['Subjects with T2D with uncontrolled A1C (7.1-10%) and LDL-c (>2.0\u2009mmol/L', '200 subjects were enrolled: mean age 59\u2009±\u200910\u2009years; mean A1C 8.0%; mean LDL-c 2.5\u2009mmol/L; 97% on statin therapy', 'subjects with T2D, the initiation of colesevelam or', 'type 2 diabetes (T2D']","['colesevelam and ezetimibe', 'Colesevelam vs. Ezetimibe', 'colesevelam 3.75\u2009g or ezetimibe 10\u2009mg daily', 'ezetimibe']","['Mean A1C', 'proportion of participants achieving LDL-c target ≤2.0\u2009mmol/L and A1C target ≤7.0', 'LDL-c reduction', 'efficacy and safety', 'similar proportion of participants with colesevelam', 'LDL-c reduction and better toleratability', 'Adverse events (AE) and discontinuation rates']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0541155', 'cui_str': 'colesevelam'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0541155', 'cui_str': 'colesevelam'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C4517697', 'cui_str': '3.75'}, {'cui': 'C1166438', 'cui_str': 'ezetimibe 10 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0541155', 'cui_str': 'colesevelam'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",200.0,0.101302,"LDL-c reduction from baseline was less with colesevelam compared to ezetimibe (14.0% vs. 23.2%, p < 0.01), as was the proportion of subjects achieving LDL-c target ≤2.0 mmol/L (47.6% and 67.0%, respectively; p = 0.007).","[{'ForeName': 'Harpreet S', 'Initials': 'HS', 'LastName': 'Bajaj', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Brown', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Dishay', 'Initials': 'D', 'LastName': 'Jiandani', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Karri', 'Initials': 'K', 'LastName': 'Venn', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Al-Asaad', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Hasnain', 'Initials': 'H', 'LastName': 'Khandwala', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Steen', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Suzan', 'Initials': 'S', 'LastName': 'Abdel-Salam', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Ronnie', 'Initials': 'R', 'LastName': 'Aronson', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14084']
1010,32406655,Three-Dimensional Volumetric Changes After Socket Augmentation with Deproteinized Bovine Bone and Collagen Matrix.,"PURPOSE


Socket augmentation decreases the magnitude of alveolar ridge resorption, but the literature is limited in respect to quantifying soft tissue remodeling. The aim of this study was to determine the volumetric and linear dimensional changes at the buccal surface for both hard and soft tissues after socket augmentation treated with a xenogeneic collagen matrix in combination with bone grafting.
MATERIALS AND METHODS


Twenty-four individuals indicated for tooth extraction were enrolled in this investigation. Each participant was randomly assigned to one of two groups: (1) deproteinized bovine bone + collagen plug, or (2) deproteinized bovine bone + xenogeneic collagen matrix. A cone beam computed tomography scan was taken prior to extraction and at 6 months postextraction. Intraoral scanning images were taken at baseline, 3 months, and 6 months postextraction. Hard and soft tissue analyses were performed to compare linear ridge remodeling and volumetric changes by noncontact reverse-engineering software.
RESULTS


Both groups showed bone and soft tissue remodeling. For hard tissue remodeling, there was no significant difference between the collagen plug and collagen matrix groups. For soft tissue remodeling, the collagen matrix group showed a reduced soft tissue loss compared with the collagen plug group. The volumetric analysis demonstrated that the mean buccal soft tissue volume loss for the collagen matrix group was 68.6 mm 3  compared with 87.6 mm 3  found in the collagen plug group (P = .009) over a 6-month period.
CONCLUSION


This clinical investigation provides early evidence of using the total tissue volume to compare soft and hard tissue remodeling after socket augmentation. The results of this study demonstrated that the use of a xenogeneic collagen matrix reduced the buccal soft tissue loss after tooth extraction, but additional studies are necessary to evaluate the clinical significance of soft tissue augmentation after tooth extraction.",2020,"For hard tissue remodeling, there was no significant difference between the collagen plug and collagen matrix groups.",['Twenty-four individuals indicated for tooth extraction were enrolled in this investigation'],"['Deproteinized Bovine Bone and Collagen Matrix', 'xenogeneic collagen matrix', 'deproteinized bovine bone + collagen plug, or (2) deproteinized bovine bone + xenogeneic collagen matrix']","['mean buccal soft tissue volume loss', 'alveolar ridge resorption', 'soft tissue loss', 'bone and soft tissue remodeling', 'buccal soft tissue loss']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}]","[{'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0182324', 'cui_str': 'Plug'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0447411', 'cui_str': 'Alveolar ridge structure'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}]",24.0,0.0170066,"For hard tissue remodeling, there was no significant difference between the collagen plug and collagen matrix groups.","[{'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Morelli', 'Affiliation': ''}, {'ForeName': 'Shaoping', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Monaghan', 'Affiliation': ''}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Moss', 'Affiliation': ''}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Lopez', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Marchesan', 'Affiliation': ''}]",The International journal of oral & maxillofacial implants,['10.11607/jomi.7961']
1011,30408205,THE INITIAL ASSESSMENT OF A COMMUNITY-BASED INTERVENTION WITH MEXICAN-HERITAGE PARENTS IN BOOSTING THE EFFECTS OF A SUBSTANCE USE PREVENTION INTERVENTION WITH YOUTH.,"Drawing from an ecodevelopmental framework, this article examines if adding a parenting component, Families Preparing the New Generation (Familias Preparando la Nueva Generación), to an efficacious classroom-based drug abuse prevention intervention, keepin'it REAL, will boost the effects of the youth intervention in preventing substance use for middle school Mexican-heritage students. Youth attending schools in a large urban area in the Southwestern U.S. (N = 462) were randomly assigned to 1 of 3 conditions: parent and youth, youth only, or control. Using ordinary least squares regression, changes in youth substance use outcomes were examined. Results indicate that youth whose parents also participated in prevention programming exhibited significantly lower use of alcohol, cigarettes, marijuana, and inhalants compared to youth who received only keepin'it REAL. These initial effects indicate that involving parents in prevention efforts can strengthen the overall efficacy of a youth prevention intervention. This article discusses specific implications for the design of prevention interventions, policy, and future research.",2019,"Results indicate that youth whose parents also participated in prevention programming exhibited significantly lower use of alcohol, cigarettes, marijuana, and inhalants compared to youth who received only keepin'it REAL.","['middle school Mexican-heritage students', 'Youth attending schools in a large urban area in the Southwestern U.S', 'N\xa0=\xa0462']",[],[],"[{'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0557295', 'cui_str': 'Attending school (finding)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]",[],[],462.0,0.0131953,"Results indicate that youth whose parents also participated in prevention programming exhibited significantly lower use of alcohol, cigarettes, marijuana, and inhalants compared to youth who received only keepin'it REAL.","[{'ForeName': 'Flavio F', 'Initials': 'FF', 'LastName': 'Marsiglia', 'Affiliation': 'Arizona State University.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Ayers', 'Affiliation': 'Arizona State University.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Robbins', 'Affiliation': 'Arizona State University.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Nagoshi', 'Affiliation': 'Arizona State University.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Baldwin-White', 'Affiliation': 'University of Georgia.'}, {'ForeName': 'Felipe González', 'Initials': 'FG', 'LastName': 'Castro', 'Affiliation': 'Arizona State University.'}]",Journal of community psychology,['10.1002/jcop.21723']
1012,31970563,Efficacy of CO lasers in preventing dental caries in partially erupted first permanent molars: a randomized 18-month clinical trial.,"The aim of this controlled randomized double-blinded clinical trial was to evaluate the use of a CO 2  laser with or without topical application of acidulated fluorides in the prevention of dental caries in partially erupted first permanent molars. We selected 61 healthy children at high risk of caries, all between 6 and 8 (7.1 ± 0.8) years of age and with 4 partially erupted first permanent molars. A CO 2  laser device emitting at 10.6 μm was used (0.5 W, 0.05 mJ per pulse, 10 kHz). Each first molar in an individual was randomly assigned to one treatment: (L) CO 2  laser (0.066 J/cm 2 ); (FL) 1.23% acidulated fluoride gel and CO 2  laser (0.066 J/cm 2 ); (V) 5% fluoride varnish, or (S) sealant (control). Patients were followed-up at 3, 6, 12, and 18 months after treatment, through direct visual examination and by an operator blinded to the treatments (kappa ≥ 0.70). The International Caries Detection and Assessment System (ICDAS-II) index was used to assess the soundness of tooth structure or the presence of white spot lesions, cavitated enamel, and/or dentin lesions. The Yildiz Visual Index was used to evaluate sealant retention. Results were evaluated using Kaplan-Meier survival analysis, and the hazard ratio of the treatments was estimated using shared frailty models with a gamma distribution, which considered the patient as a cluster. There were no significant differences among treatments compared to sealants. After 18 months, the use of a CO 2  laser with or without acidulated fluorides was shown to be effective in preventing caries on the occlusal surface of partially erupted permanent first molars in children at high risk for caries.",2020,"After 18 months, the use of a CO 2  laser with or without acidulated fluorides was shown to be effective in preventing caries on the occlusal surface of partially erupted permanent first molars in children at high risk for caries.","['dental caries in partially erupted first permanent molars', '61 healthy children at high risk of caries, all between 6 and 8 (7.1\u2009±\u20090.8) years of age and with 4 partially erupted first permanent molars']","['CO lasers', 'CO 2  laser with or without acidulated fluorides', 'CO 2  laser with or without topical application of acidulated fluorides']",['Yildiz Visual Index'],"[{'cui': 'C0011334', 'cui_str': 'Dental Decay'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0016327', 'cui_str': 'Fluorides'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",61.0,0.106462,"After 18 months, the use of a CO 2  laser with or without acidulated fluorides was shown to be effective in preventing caries on the occlusal surface of partially erupted permanent first molars in children at high risk for caries.","[{'ForeName': 'Cristina Bueno', 'Initials': 'CB', 'LastName': 'Brandão', 'Affiliation': 'Department of Pediatric Dentistry, Ribeirão Preto School of Dentistry, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Silmara Aparecida Milori', 'Initials': 'SAM', 'LastName': 'Corona', 'Affiliation': 'Department of Restorative Dentistry, Ribeirão Preto School of Dentistry, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Carolina Paes', 'Initials': 'CP', 'LastName': 'Torres', 'Affiliation': 'Department of Pediatric Dentistry, Ribeirão Preto School of Dentistry, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Alessandra Afonso', 'Initials': 'AA', 'LastName': 'Côrrea-Marques', 'Affiliation': 'Department of Pediatric Dentistry, Ribeirão Preto School of Dentistry, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Maria Conceição Pereira', 'Initials': 'MCP', 'LastName': 'Saraiva', 'Affiliation': 'Department of Pediatric Dentistry, Ribeirão Preto School of Dentistry, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Borsatto', 'Affiliation': 'Department of Pediatric Dentistry, Ribeirão Preto School of Dentistry, University of São Paulo, Ribeirão Preto, São Paulo, Brazil. borsatto@forp.usp.br.'}]",Lasers in medical science,['10.1007/s10103-020-02967-7']
1013,32406573,Efficacy and safety of lobeglitazone versus sitagliptin as an add-on to metformin in patients with type 2 diabetes with two or more components of metabolic syndrome over 24 weeks.,"We aimed to evaluate the efficacy and safety profile of lobeglitazone compared with sitagliptin as an add-on to metformin in patients with type 2 diabetes as well as other components of metabolic syndrome. Patients inadequately controlled by metformin were randomly assigned to lobeglitazone (0.5 mg, n = 121) or sitagliptin (100 mg, n = 126) for 24 weeks. The mean changes in HbA1c of the lobeglitazone and sitagliptin groups were -0.79% and -0.86%, respectively; the between-group difference was 0.08% (95% confidence interval, -0.14% to 0.30%), showing non-inferiority. The proportion of patients having two or more factors of other metabolic syndrome components decreased to a greater extent in the lobeglitazone group than in the sitagliptin group (-11.9% vs. -4.8%; P < .0174). Favourable changes in the lipid metabolism were also observed with lobeglitazone, which had a similar safety profile to sitagliptin. Lobeglitazone was comparable with sitagliptin as an add-on to metformin in terms of efficacy and safety.",2020,Lobeglitazone was comparable to sitagliptin as an add-on to metformin in terms of their efficacy and safety.,"['type 2 diabetes with metabolic syndrome over 24\u2009weeks', 'patients with type 2 diabetes mellitus (T2DM', 'Patients inadequately controlled by']","['Lobeglitazone', 'lobeglitazone', 'metformin', 'sitagliptin', 'lobeglitazone versus sitagliptin']","['lipid metabolism', 'metabolic syndrome components', 'Efficacy and safety', 'efficacy and safety profile', 'efficacy and safety']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332298', 'cui_str': 'Controlled by'}]","[{'cui': 'C2744790', 'cui_str': 'lobeglitazone'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}]","[{'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",126.0,0.0305888,Lobeglitazone was comparable to sitagliptin as an add-on to metformin in terms of their efficacy and safety.,"[{'ForeName': 'Sin Gon', 'Initials': 'SG', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Kyoung Jin', 'Initials': 'KJ', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Kun Ho', 'Initials': 'KH', 'LastName': 'Yoon', 'Affiliation': ""Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea , Seoul, South Korea.""}, {'ForeName': 'Sung Wan', 'Initials': 'SW', 'LastName': 'Chun', 'Affiliation': 'Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Soonchunhyang University College of Medicine, Cheonan, South Korea.'}, {'ForeName': 'Kyong Soo', 'Initials': 'KS', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Kyung Mook', 'Initials': 'KM', 'LastName': 'Choi', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, College of Medicine, South Korea University Guro Hospital, Seoul, South Korea.'}, {'ForeName': 'Soo', 'Initials': 'S', 'LastName': 'Lim', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.'}, {'ForeName': 'Ji-Oh', 'Initials': 'JO', 'LastName': 'Mok', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, South Korea.'}, {'ForeName': 'Hyoung Woo', 'Initials': 'HW', 'LastName': 'Lee', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, South Korea.'}, {'ForeName': 'Ji A', 'Initials': 'JA', 'LastName': 'Seo', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University Ansan Hospital, Korea University College of Medicine, Ansan, South Korea.'}, {'ForeName': 'Bong-Soo', 'Initials': 'BS', 'LastName': 'Cha', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Mi Kyung', 'Initials': 'MK', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Inje University Haeundae Paik Hospital, Inje University College of Medicine, Busan, South Korea.'}, {'ForeName': 'Ho Sang', 'Initials': 'HS', 'LastName': 'Shon', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Dong Seop', 'Initials': 'DS', 'LastName': 'Choi', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Doo Man', 'Initials': 'DM', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, South Korea.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14085']
1014,30579958,The influence of oxytocin on eating behaviours and stress in women with bulimia nervosa and binge eating disorder.,"The current study aimed to test the influence of oxytocin on palatable food intake, 24-h caloric consumption, and stress in women with bulimia nervosa and binge eating disorder. We recruited 25 women with DSM-5 bulimia nervosa or binge eating disorder, and 27 weight-matched comparison women without history of an eating disorder. We employed a double-blind, placebo-controlled crossover design in which each participant attended the lab for two experimental sessions, receiving a divided dose of 64IU intranasal oxytocin in one session and equivalent volume of placebo nasal spray in the opposite session. The order of administration was pseudo-randomised across participants. We hypothesised that a divided dose of 64IU intranasal oxytocin administration would reduce subjective hunger, the immediate consumption of palatable food, 24-h calorie consumption, and the incidence of binge eating when compared to placebo. We also hypothesised that oxytocin administration would be associated with lower levels of stress and salivary cortisol, and that there would be an interaction with participant group such that oxytocin would reduce eating behaviour and stress to a greater degree in women with bulimia nervosa or binge eating disorder, compared to women without history of an eating disorder. We did not find a significant effect of oxytocin on any of the measurements of eating behaviour, subjective stress, or salivary cortisol. We recommend that future studies test the dose-response effect of oxytocin on eating behaviours and stress in human populations with eating disorders to further clarify the moderating factors for oxytocin's effect on eating.",2019,"We did not find a significant effect of oxytocin on any of the measurements of eating behaviour, subjective stress, or salivary cortisol.","['human populations with eating disorders', 'women with bulimia nervosa or binge eating disorder', '25 women with DSM-5 bulimia nervosa or binge eating disorder, and 27 weight-matched comparison women without history of an eating disorder', 'women with bulimia nervosa and binge eating disorder']","['placebo nasal spray', '64IU intranasal oxytocin', 'placebo', 'oxytocin']","['palatable food intake, 24-h caloric consumption, and stress', 'eating behaviour, subjective stress, or salivary cortisol', 'eating behaviour and stress', 'eating behaviours and stress', 'subjective hunger, the immediate consumption of palatable food, 24-h calorie consumption, and the incidence of binge eating']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2267227', 'cui_str': 'Bulimia Nervosa'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0461725', 'cui_str': 'Nasal Spray'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}]",25.0,0.25572,"We did not find a significant effect of oxytocin on any of the measurements of eating behaviour, subjective stress, or salivary cortisol.","[{'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Leslie', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience (IoPPN) - King's College London (KCL), London, United Kingdom. Electronic address: monica.leslie@kcl.ac.uk.""}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Leppanen', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience (IoPPN) - King's College London (KCL), London, United Kingdom.""}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Paloyelis', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience (IoPPN) - King's College London (KCL), London, United Kingdom.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Treasure', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience (IoPPN) - King's College London (KCL), London, United Kingdom.""}]",Molecular and cellular endocrinology,['10.1016/j.mce.2018.12.014']
1015,31977632,Nonexercise Equations for Determining Change in Cardiorespiratory Fitness.,"PURPOSE


This study aimed to determine whether change in estimated cardiorespiratory fitness (eCRF) is associated with change in measured cardiorespiratory fitness (mCRF) independent of exercise amount and intensity over 24 wk.
METHODS


Participants were 163 sedentary adults with abdominal obesity (mean ± SD waist circumference, 109.9 ± 11.5 cm) randomly assigned to (i) no-exercise control (n = 42); (ii) low-amount, low-intensity exercise (LALI; n = 39); (iii) high-amount, low-intensity exercise (HALI; n = 51); and (iv) high-amount, high-intensity exercise (HAHI; n = 31). mCRF was measured using a maximal treadmill test at baseline, 8, 16, and 24 wk. eCRF was calculated using a published nonexercise equation with the following variables: sex, age, waist circumference, resting heart rate, and self-selected physical activity.
RESULTS


Participants attended 115 of 120 exercise sessions prescribed (96.0% ± 4.0% adherence). eCRF change from baseline to 8, 16, and 24 wk was not different from mCRF change for control, LALI, or HALI (P = 0.03). In HAHI, eCRF change was significantly greater than mCRF change at all time points (P < 0.001). Further analysis revealed that change in eCRF systematically overestimated and underestimated small and large changes in mCRF, respectively, in all groups (P < 0.001).
CONCLUSIONS


eCRF change was associated with mCRF change at 24 wk independent of exercise amount but not intensity. Systematic variation between eCRF and mCRF highlights a possible limitation when using eCRF to follow change in mCRF, specifically that eCRF does not capture the individual variability of the mCRF response.",2020,"eCRF change from baseline to 8, 16 and 24 weeks was not different from mCRF change for control, LALI or HALI (P=.03).",['Participants were 163 sedentary adults with abdominal obesity (waist circumference: mean 109.9(SD'],"['i) no-exercise control (n=42), ii) low-amount, low-intensity exercise (LALI; n=39), iii) high-amount, low-intensity exercise (HALI; n=51), iv) high-amount, high-intensity exercise']","['eCRF', 'mCRF', 'mCRF change', 'eCRF change']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0311277', 'cui_str': 'Central Obesity'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",163.0,0.0607952,"eCRF change from baseline to 8, 16 and 24 weeks was not different from mCRF change for control, LALI or HALI (P=.03).","[{'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'DE Lannoy', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, Kingston, Ontario, CANADA.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ross', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, Kingston, Ontario, CANADA.""}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002284']
1016,31977324,Increased Muscle Strength Limits Postural Sway During Daily Living Activities in Total Hip Arthroplasty Patients.,"OBJECTIVE


The aim of the study was to investigate the effect of maximal strength training on postural sway after total hip arthroplasty, performed before and after a battery of physical performance tests that resemble daily living activities.
DESIGN


This study is an exploratory study based on data from a 3-mo randomized controlled trial involving 54 total hip arthroplasty patients performing maximal strength training or conventional rehabilitation. At 3, 6, and 12 mos postoperatively, postural sway was evaluated in two gait tests; ie, one test before and one test after conducting a battery of physical performance tests.
RESULTS


At 3 mos postoperatively, postural sway in the test after was significantly higher for the conventional rehabilitation group than the maximal strength training group (P = 0.045); however, there was no between-group difference at the test before (P = 0.670). Postural sway was also significantly higher in the test after compared with the test before in the conventional rehabilitation group (P < 0.001). No difference was found between the test before and test after in the maximal strength training group (P = 0.713). At 6 and 12 mos postoperatively, there were no statistically significant within- or between-group differences in postural sway.
CONCLUSIONS


Increased muscular strength limits postural sway 3 mos postoperatively in total hip arthroplasty patients after a demanding battery of physical performance tests simulating daily living activities.",2020,"At 6 and 12 months postoperatively, there were no statistically significant within- or between-group differences in postural sway.
","['total hip arthroplasty patients', 'postural sway after total hip arthroplasty (THA', '54 THA patients performing']","['MST or conventional rehabilitation (CR', 'MST', 'maximal strength training (MST']","['postural sway in the TA', 'postural sway', 'Postural sway', 'TB and TA']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}]",54.0,0.0278132,"At 6 and 12 months postoperatively, there were no statistically significant within- or between-group differences in postural sway.
","[{'ForeName': 'Siri B', 'Initials': 'SB', 'LastName': 'Winther', 'Affiliation': 'From the Orthopedic Research Centre, Department of Orthopedic Surgery, Clinic of Orthopedics, Rheumatology and Dermatology, St. Olavs Hospital HF, Trondheim, Norway (SBW, OAF, JK); Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Science, NTNU, Norwegian University of Science and Technology, Trondheim, Norway (SBW, OAF); Department of Orthopedic Surgery, Clinic of Orthopedics, Rheumatology and Dermatology, St. Olavs Hospital HF, Trondheim, Norway (SBW, OAF, JK, VSH); Department of Circulation and Medical Imaging, Faculty of Medicine and Health Science, NTNU, Norwegian University of Science and Technology, Trondheim, Norway (VSH); and OsloMet - Oslo Metropolitan University, Faculty of Health Sciences, Institute of Nursing, Oslo, Norway (VSH).'}, {'ForeName': 'Olav A', 'Initials': 'OA', 'LastName': 'Foss', 'Affiliation': ''}, {'ForeName': 'Jomar', 'Initials': 'J', 'LastName': 'Klaksvik', 'Affiliation': ''}, {'ForeName': 'Vigdis S', 'Initials': 'VS', 'LastName': 'Husby', 'Affiliation': ''}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001382']
1017,31977634,Timing of Vaccination after Training: Immune Response and Side Effects in Athletes.,"OBJECTIVES


Influenza vaccination was used to assess whether induction of immunity or side effects are influenced by the timing of the last training session before vaccination.
METHODS


Forty-five healthy athletes (36 male, 23 ± 8 yr, ≥5 training sessions per week, predominantly national competition level) were vaccinated with the tetravalent influenza vaccine; blood samples were collected immediately before and 1, 2, and 26 wk after vaccination. Athletes were randomly assigned to vaccination within 2 h after the last training session versus after 24-26 h. Influenza-specific T cells were quantified after stimulation with the vaccine based on intracellular cytokine staining. Antibodies (IgA, IgG, IgM) were quantified by enzyme-linked immunosorbent assay and neutralization assay. Participants documented resulting side effects and training restrictions using a standardized diary.
RESULTS


Both groups showed an increase in influenza-reactive CD4 T-cell levels, which peaked 1 wk after vaccination (fold changes to baseline; median (interquartile range), 3.7 (3.0-5.4; P < 0.001) in the 2-h group; 4.6 (2.8-7.4; P < 0.001) in the 26-h group) with no difference between groups (P = 0.52). Influenza-specific antibodies showed a significant increase after vaccination in both groups (at least 1.4-fold, each P < 0.001, no group differences; P = 0.24-0.97 for different antibody types). Only antibodies toward the Brisbane strain showed a trend toward significant differences in neutralization titers between groups (4-fold (2-17.8) in the 2-h group, 16-fold (4-32.9) in the 26-h group; P = 0.06), whereas other specificities did not differ (P = 0.16-0.72). No intergroup differences were found for side effects; no athlete reported a loss of training time due to the vaccination or its side effects.
CONCLUSION


Infection prophylaxis in elite athletes by influenza vaccination seems to be effective and safe. Timing of vaccination after prior training does not seem to require specific constraints.",2020,"No inter-group differences were found for side effects; no athlete reported a loss of training time due to the vaccination or its side effects.
","['45 healthy athletes (36 males, 23±8 years, ≥ 5 training sessions per week, predominantly national competition level', 'elite athletes', 'Athletes']",[],"['neutralisation titers', 'influenza-reactive CD4 T-cell levels', 'loss of training time due to the vaccination or its side effects', 'side effects', 'Antibodies (IgA, IgG, IgM']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",[],"[{'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0020861', 'cui_str': 'IgM'}]",45.0,0.0411972,"No inter-group differences were found for side effects; no athlete reported a loss of training time due to the vaccination or its side effects.
","[{'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Stenger', 'Affiliation': 'Institute of Sports and Preventive Medicine, Saarland University, Saarbrücken, GERMANY.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Ledo', 'Affiliation': 'Department of Transplant and Infection Immunology, Saarland University, Homburg/Saar, GERMANY.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Ziller', 'Affiliation': 'Institute of Sports and Preventive Medicine, Saarland University, Saarbrücken, GERMANY.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schub', 'Affiliation': 'Department of Transplant and Infection Immunology, Saarland University, Homburg/Saar, GERMANY.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Schmidt', 'Affiliation': 'Department of Transplant and Infection Immunology, Saarland University, Homburg/Saar, GERMANY.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Enders', 'Affiliation': 'Laboratory Prof. G. Enders and Partners and Institute of Virology, Infectious Diseases and Epidemiology e.V., Stuttgart, GERMANY.'}, {'ForeName': 'Barbara C', 'Initials': 'BC', 'LastName': 'GÄrtner', 'Affiliation': 'Institute of Medical Microbiology and Hygiene, Saarland University, Homburg/Saar, GERMANY.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Sester', 'Affiliation': 'Department of Transplant and Infection Immunology, Saarland University, Homburg/Saar, GERMANY.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Meyer', 'Affiliation': 'Institute of Sports and Preventive Medicine, Saarland University, Saarbrücken, GERMANY.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002278']
1018,31977638,Exercise Improves Video Game Performance: A Win-Win Situation.,"PURPOSE


Video gamers exceeding screen-time limits are at greater risk of experiencing health issues associated with physical inactivity. Demonstrating that exercise has positive effects on video game performance could promote physical activity among video gamers. We investigated the short-term effects of a single session of cardiovascular exercise on the performance of the popular video game League of Legends (LoL) and explored psychosocial mechanisms.
METHODS


Twenty young video gamers played a customized LoL task preceded by a short bout of high-intensity interval training or a period of rest. The two conditions were administered on two separate days in a randomized counterbalanced fashion. Video game performance was assessed as the total number of targets eliminated as well as accuracy, defined as the ability to eliminate targets using single attacks. Short-term changes in affect after exercise as well as exercise enjoyment were also assessed.
RESULTS


Exercise improved (P = 0.027) the capacity to eliminate targets (mean ± SEM, 121.17 ± 3.78) compared with rest (111.38 ± 3.43). Exercise also enhanced accuracy (P = 0.019), with fewer targets eliminated with more than one attack after exercise (1.39 ± 0.39) compared with rest (2.44 ± 0.51). Exercise increased positive affect by 17% (P = 0.007), but neither affect nor exercise enjoyment was associated with total number of targets eliminated or accuracy.
CONCLUSION


A short bout of intense cardiovascular exercise before playing LoL improves video game performance. More studies are needed to establish whether these effects are generalizable to other video games, whether repeated bouts have summative effects, and to identify underlying mechanisms.",2020,"Exercise increased positive affect by 17% (p=0.007) but neither affect nor exercise enjoyment were associated with total number of targets eliminated or accuracy.
",['Twenty young video gamers played a'],"['cardiovascular exercise', 'customized LoL task preceded by a short bout of high-intensity interval training or a period of rest']","['total number of targets eliminated or accuracy', 'exercise enjoyment', 'video game performance', 'Video game performance', 'Exercise Improves Video Game Performance']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0032214', 'cui_str': 'Play'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",20.0,0.0927857,"Exercise increased positive affect by 17% (p=0.007) but neither affect nor exercise enjoyment were associated with total number of targets eliminated or accuracy.
","[{'ForeName': 'Bernat', 'Initials': 'B', 'LastName': 'DE Las Heras', 'Affiliation': 'Memory and Motor Rehabilitation Laboratory (MEMORY-LAB), Feil and Oberfeld Research Centre, Jewish Rehabilitation Hospital, Montreal Center for Interdisciplinary Research in Rehabilitation (CRIR), Laval, Quebec, CANADA.'}, {'ForeName': 'Orville', 'Initials': 'O', 'LastName': 'Li', 'Affiliation': 'Memory and Motor Rehabilitation Laboratory (MEMORY-LAB), Feil and Oberfeld Research Centre, Jewish Rehabilitation Hospital, Montreal Center for Interdisciplinary Research in Rehabilitation (CRIR), Laval, Quebec, CANADA.'}, {'ForeName': 'Lynden', 'Initials': 'L', 'LastName': 'Rodrigues', 'Affiliation': 'Memory and Motor Rehabilitation Laboratory (MEMORY-LAB), Feil and Oberfeld Research Centre, Jewish Rehabilitation Hospital, Montreal Center for Interdisciplinary Research in Rehabilitation (CRIR), Laval, Quebec, CANADA.'}, {'ForeName': 'Jean-FranÇois', 'Initials': 'JF', 'LastName': 'Nepveu', 'Affiliation': 'Memory and Motor Rehabilitation Laboratory (MEMORY-LAB), Feil and Oberfeld Research Centre, Jewish Rehabilitation Hospital, Montreal Center for Interdisciplinary Research in Rehabilitation (CRIR), Laval, Quebec, CANADA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Roig', 'Affiliation': 'Memory and Motor Rehabilitation Laboratory (MEMORY-LAB), Feil and Oberfeld Research Centre, Jewish Rehabilitation Hospital, Montreal Center for Interdisciplinary Research in Rehabilitation (CRIR), Laval, Quebec, CANADA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002277']
1019,31977668,A Biomechanical Study of Tuberosity-Based Locked Plate Fixation Compared with Standard Proximal Humeral Locking Plate Fixation for 3-Part Proximal Humeral Fractures.,"BACKGROUND


One of the main shortcomings of current proximal humeral plate designs is their inability to reliably secure the greater tuberosity (GT) or lesser tuberosity, leading to fixation failure, nonunion, and rotator cuff dysfunction. Traditional proximal humeral locking plates (PHLPs) rely on isolated screw fixation or suture repair to maintain reduction of the greater and/or lesser tuberosities. This study evaluates a tuberosity-based plate (TBP) specifically designed to improve tuberosity fixation, which may decrease tuberosity displacement and related clinical sequelae.
METHODS


Five cadaveric specimens (10 shoulders) were randomized to receive either standard PHLP or TBP fixation. The specimens were skeletonized except for the rotator cuff insertion on the GT. A reproducible 3-part osteotomy was performed for each cadaver, creating head, shaft, and GT segments. Anatomic reduction and plate fixation were performed according to the surgical technique guide for each plate system, with an equal number of screws placed in each plate both proximally and distally. GT fixation was enhanced with standardized suture augmentation through the rotator cuff in every specimen in both groups. In each trial, fracture displacement, load to failure, number of cycles endured, and mechanism of failure were noted.
RESULTS


The mean load to tuberosity fixation failure for the PHLP and TBP groups was 220 and 502 N (P = 0.005), respectively.
CONCLUSIONS


The TBP had a significantly higher load to failure and significantly lower mean fracture displacement compared with the PHLP.",2020,"The mean load to tuberosity fixation failure for the PHLP and TBP groups was 220N and 502N (p=0.005), respectively.
","['Five cadaveric specimens (ten shoulders', 'Three Part Proximal Humeral Fractures']","['standardized suture augmentation', 'standard proximal humeral locking plate (PHLP) or tuberosity-based plate fixation (TBP', 'Traditional proximal humeral locking plates', 'Tuberosity-Based Locked Plate Fixation Compared to Standard Proximal Humeral Locking Plate Fixation']","['fracture displacement, load to failure, number of cycles endured, and mechanism of failure', 'mean fracture displacement', 'mean load to tuberosity fixation failure', 'GT fixation', 'Anatomic reduction and plate fixation']","[{'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0037006', 'cui_str': 'Humeral Fractures, Proximal'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0077021', 'cui_str': 'tributyl phosphate'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}]","[{'cui': 'C0585059', 'cui_str': 'Fracture with displacement'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}]",,0.0175279,"The mean load to tuberosity fixation failure for the PHLP and TBP groups was 220N and 502N (p=0.005), respectively.
","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Walker', 'Affiliation': 'Department of Orthopaedic Surgery, University of Arizona College of Medicine-Phoenix, Phoenix, AZ.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Castaneda', 'Affiliation': 'Department of Orthopaedic Surgery, University of Arizona College of Medicine-Phoenix, Phoenix, AZ.'}, {'ForeName': 'Jill G', 'Initials': 'JG', 'LastName': 'Putnam', 'Affiliation': 'Department of Orthopaedic Surgery, University of Arizona College of Medicine-Phoenix, Phoenix, AZ.'}, {'ForeName': 'Emil H', 'Initials': 'EH', 'LastName': 'Schemitsch', 'Affiliation': 'Department of Surgery, Western University, London, ON, Canada.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'McKee', 'Affiliation': 'Department of Orthopaedic Surgery, University of Arizona College of Medicine-Phoenix, Phoenix, AZ.'}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001744']
1020,31964428,"Daily intake of non-fried potato does not affect markers of glycemia and is associated with better diet quality compared to refined grains: A randomized, crossover study in healthy adults.","Epidemiologic studies suggest that consumption of potatoes is associated with increased risk of cardiometabolic diseases. However, few clinical trials have empirically tested these observational findings. The aim of this single-blind, randomized, crossover study was to evaluate the effect of daily potato consumption, compared to refined grains, on risk factors for cardiometabolic diseases. It was hypothesized that no difference in cardiometabolic endpoints would be detected between conditions, but diet quality would improve with potato consumption. Healthy participants on self-selected diets received one potato-based side dish or one refined grain-based side dish daily, for four weeks, separated by a minimum two-week break. Dishes were isocaloric, carbohydrate-matched, and prepared without excess saturated fat or sodium. Participants were instructed to consume the side-dish with a meal in place of carbohydrates habitually consumed. Lipids/lipoproteins, markers of glycemic control, blood pressure (BP), weight and pulse wave velocity (PWV) were measured at baseline and condition endpoints. Diet quality was calculated, based on 24-hour recalls, using the Healthy Eating Index (HEI)-2015. Fifty adults (female n=34; age: 40±13; BMI: 24.5±3.6 kg/m2) completed this study. No between-condition differences were detected for fasting plasma glucose (-0.97; mg/dL, 95% CI: -2.3, 0.35; p=0.15), the primary outcome, or any other outcomes. Compared with refined grains, the HEI-2015 score (3.5, 95%CI: 0.6, 6.4 p=0.01), potassium (547 mg, 95%CI: 331, 764, p<0.001) and fiber (2.4 g, 95% CI: 0.6, 4.2, p=0.01) were higher following the potato condition. Consuming non-fried potatoes resulted in higher diet quality, potassium and fiber intake, without adversely affecting cardiometabolic risk.",2020,"Compared with refined grains, the HEI-2015 score (3.5, 95%CI: 0.6, 6.4 p=0.01), potassium (547 mg, 95%CI: 331, 764, p<0.001) and fiber (2.4 g, 95% CI: 0.6, 4.2, p=0.01) were higher following the potato condition.","['Fifty adults (female n=34; age: 40±13; BMI: 24.5±3.6 kg/m2) completed this study', 'healthy adults', 'Healthy participants on self-selected diets received one']","['potato-based side dish or one refined grain-based side dish daily', 'daily potato consumption', 'isocaloric, carbohydrate-matched, and prepared without excess saturated fat or sodium']","['Diet quality', 'Lipids/lipoproteins, markers of glycemic control, blood pressure (BP), weight and pulse wave velocity (PWV', 'Healthy Eating Index', 'cardiometabolic risk', 'diet quality, potassium and fiber intake', 'cardiometabolic endpoints', 'diet quality', 'HEI-2015 score', 'fasting plasma glucose']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0032846', 'cui_str': 'Potato'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0020498', 'cui_str': 'Vertebral Ankylosing Hyperostosis'}, {'cui': 'C0086369', 'cui_str': 'Grain (substance)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C0597423', 'cui_str': 'Fatty Acids, Saturated'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}]",50.0,0.184734,"Compared with refined grains, the HEI-2015 score (3.5, 95%CI: 0.6, 6.4 p=0.01), potassium (547 mg, 95%CI: 331, 764, p<0.001) and fiber (2.4 g, 95% CI: 0.6, 4.2, p=0.01) were higher following the potato condition.","[{'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Johnston', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA16802.'}, {'ForeName': 'K S', 'Initials': 'KS', 'LastName': 'Petersen', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA16802.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Kris-Etherton', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA16802.'}]",The British journal of nutrition,['10.1017/S0007114520000252']
1021,31960133,Prospective multicenter study of reduced port surgery combined with transvaginal specimen extraction for colorectal cancer resection.,"PURPOSE


The relevance of transvaginal specimen extraction (TVSE) combined with reduced port surgery (RPS) remains unknown. This study investigated the feasibility of TVSE with RPS according to short-term outcomes and cosmesis.
METHODS


This prospective multicenter study enrolled ten patients at three institutions. For the semi-quantification of each parameter, we administered questionnaires to assess pain (visual analogue scale), subjective/objective wound healing esthetics [photo series questionnaires (PSQ)], and quality of life (QOL).
RESULTS


No operative complications occurred, except one case of urinary tract infection, which was promptly cured with antibiotics. On day 0, pain was rated at 2.3 ± 0.67 at rest and 4.9 ± 0.82 during sneezing; these ratings gradually declined over time. The PSQ showed that the patient ratings of wound esthetics after TVSE were not inferior to ratings from patients after conventional laparoscopy or single incision laparoscopic surgery, and they were significantly higher than the patient ratings of wounds after laparotomy (P < 0.05). The QOL scores showed that, in comparison to before surgery, after surgery, patients reported significant deterioration of their physical function (96.67 ± 1.49 vs. 87.33 ± 2.71), emotional function (93.33 ± 2.72 vs. 86.67 ± 2.22), fatigue (7.78 ± 3.72 vs. 26.67 ± 8.31), and pain (6.67 ± 3.69 vs. 18.33 ± 4.61).
CONCLUSION


TVSE with RPS for colorectal cancer was feasible and was associated with a low degree of postoperative pain.",2020,"The QOL scores showed that, in comparison to before surgery, after surgery, patients reported significant deterioration of their physical function (96.67 ± 1.49 vs. 87.33 ± 2.71), emotional function (93.33 ± 2.72 vs. 86.67 ± 2.22), fatigue (7.78 ± 3.72 vs. 26.67 ± 8.31), and pain (6.67 ± 3.69 vs. 18.33 ± 4.61).
","['colorectal cancer resection', 'enrolled ten patients at three institutions']","['TVSE with RPS', 'transvaginal specimen extraction (TVSE) combined with reduced port surgery (RPS', 'reduced port surgery combined with transvaginal specimen extraction']","['emotional function', 'patient ratings of wound esthetics', 'pain (visual analogue scale), subjective/objective wound healing esthetics [photo series questionnaires (PSQ)], and quality of life (QOL', 'operative complications', 'QOL scores', 'deterioration of their physical function', 'fatigue', 'pain', 'urinary tract infection']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C0175672', 'cui_str': 'Vaginal approach (qualifier value)'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0452253', 'cui_str': 'Port (substance)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0205549', 'cui_str': 'Series (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}]",10.0,0.0322945,"The QOL scores showed that, in comparison to before surgery, after surgery, patients reported significant deterioration of their physical function (96.67 ± 1.49 vs. 87.33 ± 2.71), emotional function (93.33 ± 2.72 vs. 86.67 ± 2.22), fatigue (7.78 ± 3.72 vs. 26.67 ± 8.31), and pain (6.67 ± 3.69 vs. 18.33 ± 4.61).
","[{'ForeName': 'Hidekazu', 'Initials': 'H', 'LastName': 'Takahashi', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 562-0015, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Hamabe', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 562-0015, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Hata', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 562-0015, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Nishizawa', 'Affiliation': 'Department of Colorectal and Pelvic Surgery, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 227-8577, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nishimura', 'Affiliation': 'Department of Surgery, Institute of Gastroenterology, Nagaoka Chuo General Hospital, 2041 Kawasaki-cho, Nagaoka, Niigata, 940-8653, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Itoh', 'Affiliation': 'Department of Colorectal and Pelvic Surgery, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 227-8577, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Takemasa', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 562-0015, Japan. itakemasa@sapmed.ac.jp.'}]",Surgery today,['10.1007/s00595-019-01946-y']
1022,31958417,"Addition of anti-thymocyte globulin to standard graft-versus-host disease prophylaxis versus standard treatment alone in patients with haematological malignancies undergoing transplantation from unrelated donors: final analysis of a randomised, open-label, multicentre, phase 3 trial.","BACKGROUND


Previous trials testing prevention strategies for chronic graft versus host disease (GVHD) have measured its cumulative incidence. In this trial of anti-thymocyte globulin, we measured treatment-independence at a long-term timepoint as the primary endpoint.
METHODS


This was a randomised, open-label, multicentre, phase 3 trial done at ten centres in Canada and one in Australia. Eligible patients had a haematological malignancy (leukaemia, myelodysplastic syndrome, or lymphoma), were between 16 and 70 years of age, eligible for transplantation with a Karnofsky score of at least 60, and received an unrelated donor (fully matched or one-locus mismatched at HLA-A, HLA-B, HLA-C, or DRB1 loci) graft following myeloablative or non-myeloablative-reduced intensity conditioning. Patients were randomly assigned to receive anti-thymocyte globulin 4·5 mg/kg plus standard GVHD prophylaxis (cyclosporine or tacrolimus plus methotrexate or mycophenolate) or standard GVHD prophylaxis alone. The primary endpoint, freedom from immunosuppressive therapy without resumption at 12 months, was previously reported. Here we report on the prespecified 24-month analysis. Analyses were per-protocol, excluding those patients who did not proceed to transplantation. This trial is registered as ISRCTN 29899028 and NCT01217723, status completed.
FINDINGS


Between June 9, 2010, and July 8, 2013, we recruited and randomly assigned 203 eligible patients to receive anti-thymocyte globulin (n=101) or no additional treatment (n=102) along with standard GVHD prophylaxis. 7 (3%) patients did not receive a transplant and were excluded from the analysis. 38 (38%) of 99 evaluable patients in the anti-thymocyte globulin plus GVHD prophylaxis group were free from immunosuppressive therapy at 24 months compared with 18 (19%) of 97 patients in the standard GVHD prophylaxis group (adjusted odds ratio [OR] 3·49 [95% CI 1·60–7·60]; p=0·0016). At 24 months, the cumulative incidence of relapse was 16·3% (95% CI 8·9–23·7) in the anti-thymocyte globulin plus GVHD prophylaxis group compared with 17·5 (9·9–25·1) in the standard GVHD prophylaxis group (p=0·73) and non-relapse mortality was 21·2% (95% CI 13·2–29·2) versus 31·3% (21·9–40·7; p=0·15). The cumulative incidence of chronic GVHD at 24 months was 26·3% (95% CI 17·5–35·1) in the anti-thymocyte globulin group and 41·3% (31·3–51·3) in the standard GVHD prophylaxis group (p=0·032). Overall survival at 24 months was 70·6% (95% CI 60·6–78·6) in the anti-thymocyte globulin plus GVHD prophylaxis group compared with 53·3% (42·8–62·8) in the standard GVHD prophylaxis group (adjusted hazard ratio [HR] 0·56, 95% CI [0·35–0·90]; p=0·017). Symptoms of chronic GVHD by the Lee Scale were more prevalent in the standard GVHD prophylaxis group, with scores of 13·27 (SD 10·94) in the anti-thymocyte globulin plus GVHD prophylaxis group and 20·38 (SD 14·68) in the standard GVHD prophylaxis group (p=0·040). Depressive symptoms were more prominent in the standard GVHD prophylaxis group, the mean Center for Epidemiological Studies Depression scale (CES-D) scores were 10·40 (SD 9·88) in the anti-thymocyte globulin group and 14·62 (SD 12·26) in the standard GVHD prophylaxis group (p=0·034). Serious adverse events (CTCAE grade 4 or 5) occurred in 38 (38%) patients in the anti-thymocyte globulin group and in 49 (51%) in the standard GVHD prophylaxis group, the most common being infection and GVHD. One patient in the anti-thymocyte globulin plus GVHD prophylaxis group died of Epstein-Barr virus hepatitis, but no deaths were attributable to anti-thymocyte globulin.
INTERPRETATION


The results of this prespecified 24-month analysis suggest that pretreatment with anti-thymocyte globulin provides clinically meaningful benefits when added to standard GVHD prophylaxis in patients undergoing unrelated donor transplantation, including decreases in use of immunosuppressive therapy, chronic GVHD and its symptoms, depressive symptoms, and improved overall survival. Anti-thymocyte globulin should be included in the preparative regimens of patients with haematological malignancies selected for unrelated donor transplantation.
FUNDING


Canadian Institutes of Health Research and Sanofi.",2020,"Overall survival at 24 months was 53·3% (95% CI 42·8-62·7) in the anti-thymocyte globulin plus GVHD prophylaxis group compared with 70.6% (95% CI 60·6-78·6) in the standard GVHD prophylaxis group (adjusted hazard ratio [HR] 0·56, 95% CI [0·35-0·90]; p=0·017.","['3·49', 'patients with haematological malignancies selected for unrelated donor transplantation', 'patients with haematological malignancies undergoing transplantation from unrelated donors', 'ten centres in Canada and one in Australia', 'Between June 9, 2010, and July 8, 2013, we recruited and randomly assigned 203 eligible patients to', 'Eligible patients had a haematological malignancy (leukaemia, myelodysplastic syndrome, or lymphoma), were between 16 and 70 years of age, eligible for transplantation with a Karnofsky score of at least 60, and received an unrelated donor (fully matched or one-locus mismatched at HLA-A, HLA-B, HLA-C, or DRB1 loci) graft following myeloablative or non-myeloablative-reduced intensity conditioning', 'patients undergoing unrelated donor transplantation']","['anti-thymocyte globulin', 'Anti-thymocyte globulin', 'anti-thymocyte globulin 4·5 mg/kg plus standard GVHD prophylaxis (cyclosporine or tacrolimus plus methotrexate or mycophenolate) or standard GVHD prophylaxis alone', 'receive anti-thymocyte globulin (n=101) or no additional treatment (n=102) along with standard GVHD prophylaxis', 'anti-thymocyte globulin to standard graft-versus-host disease prophylaxis']","['mean Center for Epidemiological Studies Depression scale (CES-D) scores', 'Serious adverse events', 'freedom from immunosuppressive therapy without resumption', 'Overall survival', 'relapse mortality', 'cumulative incidence of relapse', 'Depressive symptoms', 'immunosuppressive therapy, chronic GVHD and its symptoms, depressive symptoms', 'overall survival', 'cumulative incidence of chronic GVHD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376545', 'cui_str': 'Hematological Neoplasms'}, {'cui': 'C3179133', 'cui_str': 'Unrelated Donors'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C3666007', 'cui_str': 'Myelodysplastic syndrome (SMQ)'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0019728', 'cui_str': 'HLA-A'}, {'cui': 'C0019737', 'cui_str': 'HLA-B'}, {'cui': 'C0019751', 'cui_str': 'HLA-C'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0359156', 'cui_str': 'Rabbit anti-human T-lymphocyte globulin'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0002783', 'cui_str': 'Epidemiological Studies'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0021079', 'cui_str': 'Antirejection Therapy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}]",203.0,0.0916317,"Overall survival at 24 months was 53·3% (95% CI 42·8-62·7) in the anti-thymocyte globulin plus GVHD prophylaxis group compared with 70.6% (95% CI 60·6-78·6) in the standard GVHD prophylaxis group (adjusted hazard ratio [HR] 0·56, 95% CI [0·35-0·90]; p=0·017.","[{'ForeName': 'Irwin', 'Initials': 'I', 'LastName': 'Walker', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, ON, Canada; Juravinski Hospital and Cancer Centre, Hamilton, ON, Canada. Electronic address: walkeri@mcmaster.ca.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Panzarella', 'Affiliation': 'Division of Biostatistics, Dalla Lana School of Public Health, University of Toronto, Toronto ON, Canada; Department of Biostatistics, Princess Margaret Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Couban', 'Affiliation': 'Dalhousie University and Capital District Health Authority Halifax, NS, Canada.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Couture', 'Affiliation': 'Centre Hospitalier Universitaire de Québec, Pavillon Hôtel-dieu de Québec, Québec City, QC, Canada.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Devins', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto ON, Canada; Supportive Care Program, Princess Margaret Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elemary', 'Affiliation': 'Saskatoon Cancer Centre, Saskatoon, SK, Canada.'}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': 'Gallagher', 'Affiliation': 'Université Laval and CHU de Québec, Quebec city, QC, Canada.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Kerr', 'Affiliation': 'Leukemia-Bone Marrow Transplant Program of British Columbia, Vancouver General Hospital, British Columbia Cancer, and University of British Columbia, BC, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kuruvilla', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto ON, Canada; Division of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Fred Hutchinson Cancer Research Center, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Moore', 'Affiliation': ""St Vincent's Hospital, Sydney, NSW, Australia.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Nevill', 'Affiliation': 'Leukemia-Bone Marrow Transplant Program of British Columbia, Vancouver General Hospital, British Columbia Cancer, and University of British Columbia, BC, Canada.'}, {'ForeName': 'Gizelle', 'Initials': 'G', 'LastName': 'Popradi', 'Affiliation': 'Royal Victoria Hospital, McGill University Health Center Montreal, QC, Canada.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Roy', 'Affiliation': 'Université de Montréal and Maisonneuve-Rosemont Hospital, Montreal, QC, Canada.'}, {'ForeName': 'Kirk R', 'Initials': 'KR', 'LastName': 'Schultz', 'Affiliation': ""Michael Cuccione Childhood Cancer Research Program and British Columbia Children's Hospital and Child & Family Research Institute, Vancouver, BC, Canada.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Szwajcer', 'Affiliation': 'CancerCare Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Toze', 'Affiliation': 'Leukemia-Bone Marrow Transplant Program of British Columbia, Vancouver General Hospital, British Columbia Cancer, and University of British Columbia, BC, Canada.'}, {'ForeName': 'Ronan', 'Initials': 'R', 'LastName': 'Foley', 'Affiliation': 'Juravinski Hospital and Cancer Centre, Hamilton, ON, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Haematology,['10.1016/S2352-3026(19)30220-0']
1023,31965842,"Probiotics maintain intestinal secretory immunoglobulin A levels in healthy formula-fed infants: a randomised, double-blind, placebo-controlled study.","Formula-fed infants are more susceptible to infectious diseases because they lack the maternal immune factors transferred from breast milk, while their own immune system is still immature. As timely probiotic administration was suggested to promote immune system development in formula-fed infants, this study aimed at assessing the safety and the effects of a probiotic supplement ( Bifidobacterium infantis  R0033,  Bifidobacterium bifidum  R0071, and  Lactobacillus helveticus  R0052) on mucosal immune competence and digestive function in formula-fed infants. Healthy infants (3.5-6 months old) were randomised to receive either probiotic- (n=66) or placebo-supplemented (n=66) formula once a day for four weeks. In the probiotics group, faecal secretory immunoglobulin A (SIgA) levels remained similar between visit 2 (baseline; V2) and visit 3 (end-of-treatment; V3), but decreased in the placebo group. Changes in SIgA levels following treatment (log 10 ΔV3-V2 [95%CI]) between the probiotic and placebo groups were statistically significant (23 ng/dl [-57;102] and -137 ng/dl [-212;-62], respectively ( P =0.0044; ANCOVA)). While log 10 ΔV3-V2 [95%CI] for salivary SIgA levels increased in both groups, this trend was more pronounced in the probiotics than in the placebo group with an increase of 123 ng/dl [9;236] and 37 ng/dL [-72;147], respectively ( P =0.2829; ANCOVA). The weekly average number of stools/day was significantly higher in the probiotics group compared to placebo during the last week of treatment for the per protocol population. There was no difference in microbiota composition or anthropometric parameters between groups. No serious adverse event was reported, and all adverse events were mild and unrelated to the product or study. Our results show that formula-fed infants receiving probiotics maintained higher faecal SIgA levels at the end of the four-week treatment period, suggesting a positive effect of probiotics on SIgA production. This study demonstrates the safety of this probiotic formulation in infants. Formula-fed infants may benefit from probiotics supplementation to sustain the development of mucosal immunity.",2019,"While log 10 ΔV3-V2 [95%CI] for salivary SIgA levels increased in both groups, this trend was more pronounced in the probiotics than in the placebo group with an increase of 123 ng/dl [9;236] and 37 ng/dL","['Healthy infants (3.5-6 months old', 'infants', 'formula-fed infants', 'healthy formula-fed infants']","['probiotics supplementation', 'placebo', 'probiotic', 'Probiotics', 'placebo-supplemented']","['mucosal immune competence and digestive function', 'faecal SIgA levels', 'faecal secretory immunoglobulin A (SIgA) levels', 'SIgA levels', 'salivary SIgA levels', 'microbiota composition or anthropometric parameters']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0020838', 'cui_str': 'Secretory IgA'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.409129,"While log 10 ΔV3-V2 [95%CI] for salivary SIgA levels increased in both groups, this trend was more pronounced in the probiotics than in the placebo group with an increase of 123 ng/dl [9;236] and 37 ng/dL","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of Neonatology, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai 201204, China P.R.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gong', 'Affiliation': 'Department of Pediatrics, Shanghai East Hospital, Tongji University School of Medicine, Shanghai 201204, China P.R.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': ""Department of Neonatology, First People's Hospital of Zhangjiagang, Soochow University School of Medicine, Jiangsu 215600, China P.R.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Ding', 'Affiliation': ""Department of Respiratory Medicine, Shanghai Children's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200040, China P.R.""}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Lallemand Health Solutions Inc., 6100 Avenue Royalmount, Montreal, QC H4P 2R2, Canada.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Deng', 'Affiliation': 'Biostime (Guangzhou) Health Products Ltd., 187 Lianguang Rd, East District, Economic and Technological Development District Guangzhou, China P.R.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Ze', 'Affiliation': 'Biostime (Guangzhou) Health Products Ltd., 187 Lianguang Rd, East District, Economic and Technological Development District Guangzhou, China P.R.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Malard', 'Affiliation': 'Biostime (Guangzhou) Health Products Ltd., 187 Lianguang Rd, East District, Economic and Technological Development District Guangzhou, China P.R.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Ben', 'Affiliation': 'Department of Neonatology, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai 201204, China P.R.'}]",Beneficial microbes,['10.3920/BM2019.0025']
1024,30713100,Early removal of intraperitoneal drainage after pancreatoduodenectomy in patients without postoperative fistula at POD3: Results of a randomized clinical trial.,"BACKGROUND


To determine whether the timing of removal of abdominal drainage (AD) after pancreatoduodenectomy (PD) influences the 30-day surgical site infection (30-day SSI) rate.
METHODS


A multicenter randomized, intention-to-treat trial with two parallel arms (superiority of early vs. standard AD removal on SSI) was performed between 2011 and 2015 in patients with no pancreatic fistula (PF) on POD3 after PD (NCT01368094). The primary endpoint was the 30-day SSI rate. The secondary endpoints were specific post-PD complications (grade BC PF), postoperative morbidity and risk factor of SSI, reoperation rate, 30-day mortality, length of drainage, length of stay and postoperative infectious complications.
RESULTS


One hundred and forty-one patients were randomized: 71 in the early arm, 70 in the standard arm (70.2% of pancreatic adenocarcinomas; 91.5% of pancreatojejunostomies; 66.0% of bilateral drainages; feasibility: 39.9%). Early removal of drains was not associated with a significant decrease of 30-day SSI (14.1% vs. 24.3%, P=0.12). A lower rate of deep SSI was observed in the early arm (2.8% vs. 17.1%, P=0.03), leading to a shorter length of stay (17.8±6.8 vs. 21.0±6.1, P=0.01). Grade BC PF rate (5.6%), severe morbidity (17.7%), reoperation rate (7.8%), 30-day mortality (1.4%) and wound-SSI rate (7.8%) were similar between arms. After multivariate analysis, the timing of AD removal was not associated with an increase of 30-day SSI (OR=0.74 [95% CI 0.35-1.13, P=0.38]).
CONCLUSION


In selected patients with no PF on POD3, early removal of abdominal drainage does not seem to increase or decrease surgical site infection's occurrence.",2019,"Early removal of drains was not associated with a significant decrease of 30-day SSI (14.1% vs. 24.3%, P=0.12).","['One hundred and forty-one patients', 'patients with no pancreatic fistula (PF) on POD3 after PD (NCT01368094', 'patients without postoperative fistula at POD3']","['abdominal drainage (AD) after pancreatoduodenectomy (PD', 'intraperitoneal drainage after pancreatoduodenectomy']","['30-day SSI', '30-day surgical site infection (30-day SSI) rate', 'specific post-PD complications (grade BC PF), postoperative morbidity and risk factor of SSI, reoperation rate, 30-day mortality, length of drainage, length of stay and postoperative infectious complications', 'severe morbidity', 'wound-SSI rate', 'rate of deep SSI', '30-day mortality', 'shorter length of stay', 'SSI', '30-day SSI rate', 'Grade BC PF rate', 'reoperation rate', ""surgical site infection's occurrence""]","[{'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic Fistula'}, {'cui': 'C0558429', 'cui_str': 'Postoperative fistula (disorder)'}]","[{'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0085162', 'cui_str': 'Pancreatoduodenectomy'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal (qualifier value)'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}]",141.0,0.319499,"Early removal of drains was not associated with a significant decrease of 30-day SSI (14.1% vs. 24.3%, P=0.12).","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dembinski', 'Affiliation': 'Service de chirurgie digestive, CHU, Amiens, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mariette', 'Affiliation': 'Service de chirurgie digestive et oncologique, CHU de Huriez, Lille, France.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Tuech', 'Affiliation': 'Service de chirurgie digestive, CHU de Charles-Nicolle, Rouen, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Mauvais', 'Affiliation': 'Service de chirurgie digestive, CH de Beauvais, Beauvais, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Piessen', 'Affiliation': 'Service de chirurgie digestive et oncologique, CHU de Huriez, Lille, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Fuks', 'Affiliation': 'Service de chirurgie digestive, CHU, Amiens, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Schwarz', 'Affiliation': 'Service de chirurgie digestive, CHU de Charles-Nicolle, Rouen, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Truant', 'Affiliation': 'Service de chirurgie hépato biliaire et transplantation, CHU de Huriez, Lille, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cosse', 'Affiliation': 'Service de chirurgie digestive, CHU, Amiens, France.'}, {'ForeName': 'F R', 'Initials': 'FR', 'LastName': 'Pruvot', 'Affiliation': 'Service de chirurgie hépato biliaire et transplantation, CHU de Huriez, Lille, France.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Regimbeau', 'Affiliation': 'Service de chirurgie digestive, CHU, Amiens, France; Unité de recherche clinique, simplifications des soins patients chirurgicaux complexes (SSPC), CHU, Amiens, France. Electronic address: regimbeau.jean-marc@chu-amiens.fr.'}]",Journal of visceral surgery,['10.1016/j.jviscsurg.2018.06.006']
1025,31866308,Caffeine-dependent changes of sleep-wake regulation: Evidence for adaptation after repeated intake.,"BACKGROUND


Circadian and sleep-homeostatic mechanisms regulate timing and quality of wakefulness. To enhance wakefulness, daily consumption of caffeine in the morning and afternoon is highly common. However, the effects of such a regular intake pattern on circadian sleep-wake regulation are unknown. Thus, we investigated if daily daytime caffeine intake and caffeine withdrawal affect circadian rhythms and wake-promotion in habitual consumers.
METHODS


Twenty male young volunteers participated in a randomised, double-blind, within-subject study with three conditions: i) caffeine (150 mg 3 x daily for 10 days), ii) placebo (3 x daily for 10 days) and iii) withdrawal (150 mg caffeine 3 x daily for eight days, followed by a switch to placebo for two days). Starting on day nine of treatment, salivary melatonin and cortisol, evening nap sleep as well as sleepiness and vigilance performance throughout day and night were quantified during 43 h in an in-laboratory, light and posture-controlled protocol.
RESULTS


Neither the time course of melatonin (i.e. onset, amplitude or area under the curve) nor the time course of cortisol was significantly affected by caffeine or withdrawal. During withdrawal, however, volunteers reported increased sleepiness, showed more attentional lapses as well as polysomnography-derived markers of elevated sleep propensity in the late evening compared to both the placebo and caffeine condition.
CONCLUSIONS


The typical pattern of caffeine intake with consumption in both the morning and afternoon hours may not necessarily result in a circadian phase shift in the evening nor lead to clear-cut benefits in alertness. The time-of-day independent effects of caffeine withdrawal on evening nap sleep, sleepiness and performance suggest an adaptation to the substance, presumably in the homeostatic aspect of sleep-wake regulation.",2020,"During withdrawal, however, volunteers reported increased sleepiness, showed more attentional lapses as well as polysomnography-derived markers of elevated sleep propensity in the late evening compared to both placebo and caffeine conditions.
","['Twenty male young volunteers', 'habitual consumers']","['placebo', 'caffeine withdrawal', 'Caffeine', 'caffeine']","['salivary melatonin and cortisol, evening nap sleep as well as sleepiness and vigilance performance', 'attentional lapses', 'time course of melatonin (i.e. onset, amplitude or area under the curve) nor the time course of cortisol', 'sleepiness', 'wakefulness, daily consumption of caffeine']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0521652', 'cui_str': 'Caffeine withdrawal (disorder)'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C0067518', 'cui_str': 'NAPS'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0449247', 'cui_str': 'Time course (attribute)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0043012', 'cui_str': 'Wakefulnesses'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}]",20.0,0.131327,"During withdrawal, however, volunteers reported increased sleepiness, showed more attentional lapses as well as polysomnography-derived markers of elevated sleep propensity in the late evening compared to both placebo and caffeine conditions.
","[{'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Weibel', 'Affiliation': 'Centre for Chronobiology, Psychiatric Hospital of the University of Basel, Basel, Switzerland; Transfaculty Research Platform Molecular and Cognitive Neurosciences, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Yu-Shiuan', 'Initials': 'YS', 'LastName': 'Lin', 'Affiliation': 'Centre for Chronobiology, Psychiatric Hospital of the University of Basel, Basel, Switzerland; Transfaculty Research Platform Molecular and Cognitive Neurosciences, University of Basel, Basel, Switzerland; Neuropsychiatry and Brain Imaging, Psychiatric Hospital of the University of Basel, Basel, Switzerland.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Landolt', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zürich, Zürich, Switzerland; Sleep & Health Zürich, University Center of Competence, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Garbazza', 'Affiliation': 'Centre for Chronobiology, Psychiatric Hospital of the University of Basel, Basel, Switzerland; Transfaculty Research Platform Molecular and Cognitive Neurosciences, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Vitaliy', 'Initials': 'V', 'LastName': 'Kolodyazhniy', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Kistler', 'Affiliation': 'Centre for Chronobiology, Psychiatric Hospital of the University of Basel, Basel, Switzerland; Transfaculty Research Platform Molecular and Cognitive Neurosciences, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Rehm', 'Affiliation': 'Laboratory Medicine, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Rentsch', 'Affiliation': 'Laboratory Medicine, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Borgwardt', 'Affiliation': 'Neuropsychiatry and Brain Imaging, Psychiatric Hospital of the University of Basel, Basel, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Cajochen', 'Affiliation': 'Centre for Chronobiology, Psychiatric Hospital of the University of Basel, Basel, Switzerland; Transfaculty Research Platform Molecular and Cognitive Neurosciences, University of Basel, Basel, Switzerland. Electronic address: christian.cajochen@upk.ch.'}, {'ForeName': 'Carolin Franziska', 'Initials': 'CF', 'LastName': 'Reichert', 'Affiliation': 'Centre for Chronobiology, Psychiatric Hospital of the University of Basel, Basel, Switzerland; Transfaculty Research Platform Molecular and Cognitive Neurosciences, University of Basel, Basel, Switzerland.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2019.109851']
1026,31967736,"Alveolar ridge preservation with a collagen cone: Histological, histochemical, and immunohistochemical results of a randomized controlled clinical trial.","OBJECTIVES


The objective of the present study was to examine the influence of a combination material of a collagen cone and a collagen membrane on the healing process of extraction sockets with regard to histological, histochemical, and immunohistochemical parameters.
MATERIALS AND METHODS


In a prospective randomized clinical study, 10 patients (test group) received a collagen combination material after tooth removal. The extraction sockets of 10 other patients (control group) were left to heal without further intervention. Eleven ±1 weeks after tooth extraction, histological biopsies were performed in both groups at the time of implant placement. Subsequently, the biopsies were evaluated semiquantitatively in terms of histological, histochemical, and immunohistochemical parameters for the identification of factors of bone metabolism and vascularization.
RESULTS


No significant difference between test and control group were found for any parameter. According to the descriptive data, the use of a collagen combination material seems to result in slightly higher values of the osteogenic Runt-related transcription factor 2 (Runx2) and vascularization.
CONCLUSION


The histological, histochemical, and immunohistochemical analysis of ARP with a collagen cone combined with a collagen membrane showed no significant differences in terms of bone metabolism and vascularization.",2020,No significant difference between test and control group were found for any parameter.,['10 patients (test group) received a'],['collagen combination material after tooth removal'],['bone metabolism and vascularization'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}]","[{'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0027686', 'cui_str': 'Pathologic Neovascularization'}]",10.0,0.0459937,No significant difference between test and control group were found for any parameter.,"[{'ForeName': 'Sigmar', 'Initials': 'S', 'LastName': 'Schnutenhaus', 'Affiliation': 'Center of Dentistry Dr. Schnutenhaus MVZ GmbH, Hilzingen, Germany.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Edelmann', 'Affiliation': 'Department of Prosthetic Dentistry, Center of Dentistry, Ulm University, Ulm, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Dreyhaupt', 'Affiliation': 'Institute of Epidemiology and Medical Biometry, Ulm University, Ulm, Germany.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Rudolph', 'Affiliation': 'Center of Dentistry Dr. Schnutenhaus MVZ GmbH, Hilzingen, Germany.'}, {'ForeName': 'Ralph G', 'Initials': 'RG', 'LastName': 'Luthardt', 'Affiliation': 'Center of Dentistry Dr. Schnutenhaus MVZ GmbH, Hilzingen, Germany.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Goetz', 'Affiliation': 'Department of Orthodontics, Oral Biology Laboratory, University of Bonn, Bonn, Germany.'}]",Clinical and experimental dental research,['10.1002/cre2.279']
1027,31955619,Randomized trial of 3-drug combination for lumbar nerve root epidural injections with a TNF-α inhibitor in treatment of lumbar stenosis.,"Background:  This study was to assess the clinical efficacy of epidural injections with tumor necrosis factor-alpha (TNF-α) inhibitor in patients with chronic radicular pain caused by lumbar spinal stenosis (LSS). Methods:  In a randomized controlled trial (RCT), patients diagnosed with mild-to-moderate LSS underwent epidural intervention with three different drugs and were allocated to TNF-α inhibitor group (Group A), steroid group (Group B) and lidocaine-only group (Group C). All patients were evaluated by visual analog scale (VAS) for leg pain and Oswestry disability index (ODI) to assess function. They all received a 6-month follow-up. Results:  Ninety patients were randomly assigned to three groups, for 30 cases in each group. A total of 82 participants (91.1%) completed the follow-up. Pain relief and improvement of movement function after epidural administration in Group A were more significant than those of groups B and C ( p  < .05) during the 6-month follow-up, while it showed no significant difference between groups B and C ( p  > .05). Conclusions:  Our results indicated that epidural administration with TNF-α inhibitor may be a useful conservative method for the treatment of radicular pain caused by LSS.  Trial registration:  ClinicalTrials.gov Identifier: NCT04062474.",2020,"Pain relief and improvement of movement function after epidural administration in Group A were more significant than those of groups B and C ( p  < .05) during the 6-month follow-up, while it showed no significant difference between groups B and C ( p  > .05).","['A total of 82 participants (91.1%) completed the follow-up', 'lumbar stenosis', 'patients with chronic radicular pain caused by lumbar spinal stenosis (LSS', 'Ninety patients', 'patients diagnosed with mild-to-moderate LSS underwent']","['TNF-α inhibitor', 'lidocaine-only group', 'epidural intervention', 'steroid', 'epidural injections with tumor necrosis factor-alpha (TNF-α) inhibitor']","['Pain relief and improvement of movement function', 'visual analog scale (VAS) for leg pain and Oswestry disability index (ODI) to assess function']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0278147', 'cui_str': 'Radicular pain (finding)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0158288', 'cui_str': 'Spinal stenosis of lumbar region (disorder)'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0021486', 'cui_str': 'Extradural Injections'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}]",82.0,0.0554314,"Pain relief and improvement of movement function after epidural administration in Group A were more significant than those of groups B and C ( p  < .05) during the 6-month follow-up, while it showed no significant difference between groups B and C ( p  > .05).","[{'ForeName': 'Peiran', 'Initials': 'P', 'LastName': 'Wei', 'Affiliation': 'Department of Orthopaedics, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopaedics, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Qingqiang', 'Initials': 'Q', 'LastName': 'Yao', 'Affiliation': 'Department of Orthopaedics, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedics, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.'}]",British journal of neurosurgery,['10.1080/02688697.2020.1713990']
1028,30745109,Use of Everolimus and Trastuzumab in Addition to Endocrine Therapy in Hormone-Refractory Metastatic Breast Cancer.,"BACKGROUND


Increased signaling through growth factor receptor pathways, including HER2, plays a role in resistance to endocrine therapy (ET) in patients with hormone receptor (HR)-positive metastatic breast cancer (MBC). Inhibition of mechanistic target of rapamycin improves outcomes when used in addition to ET in patients with HR-positive MBC, who previously received ET. We hypothesized that the additional use of trastuzumab (T) or everolimus (E) could restore sensitivity to ET in patients with endocrine-resistant, HR-positive, HER2-negative MBC.
PATIENTS AND METHODS


Patients with endocrine-resistant HR-positive, HER2-negative MBC continued the ET during which they had experienced disease progression, and were randomized to receive T or E. At disease progression, patients could continue the therapy they were receiving and have E or T used in addition.
RESULTS


Fifty-four patients were randomized to the additional use of E (n = 30) or T (n = 24) with existing ET. Progression-free survival (PFS) was 5.7 months, and 2.2 months, respectively, and clinical benefit rate at 24 weeks was 48% and 11% for patients receiving E or T, respectively. PFS was 4.5 months and 3.1 months for patients in whom E (n = 16) or T (n = 12) was used post progression, respectively. There were no new safety signals apart from 2 patients who had a decreased ejection fraction while receiving E with ET.
CONCLUSION


These results suggest that E, but not T, can potentially reverse resistance to ET in patients with endocrine-resistant HR-positive, HER2-negative MBC. Further, the additional use of E with an ET to which the cancer has already been exposed might offer the possibility of delaying time to use of chemotherapy.",2019,"PFS was 4.5 months and 3.1 months for patients in whom E (n = 16) or T (n = 12) was used post progression, respectively.","['Fifty-four patients', 'patients with endocrine-resistant, HR-positive, HER2-negative MBC', 'Hormone-Refractory Metastatic Breast Cancer', 'patients with endocrine-resistant HR-positive, HER2-negative MBC', 'patients with hormone receptor (HR)-positive metastatic breast cancer (MBC', 'patients with HR-positive MBC', 'Patients with endocrine-resistant HR-positive, HER2-negative MBC continued the ET during which they had experienced disease progression']","['rapamycin', 'trastuzumab (T) or everolimus (E', 'Everolimus and Trastuzumab', 'endocrine therapy (ET', 'Endocrine Therapy']","['clinical benefit rate', 'PFS', 'Progression-free survival (PFS']","[{'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",54.0,0.0233542,"PFS was 4.5 months and 3.1 months for patients in whom E (n = 16) or T (n = 12) was used post progression, respectively.","[{'ForeName': 'Elisavet', 'Initials': 'E', 'LastName': 'Paplomata', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute of Emory University, Atlanta, GA.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Zelnak', 'Affiliation': 'Atlanta Cancer Care, Atlanta, GA.'}, {'ForeName': 'Cesar A', 'Initials': 'CA', 'LastName': 'Santa-Maria', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center of Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute of Emory University, Atlanta, GA; Department of Bioinformatics and Biostatistics Shared Resource, Winship Cancer Institute of Emory University, Atlanta, GA.'}, {'ForeName': 'Keerthi', 'Initials': 'K', 'LastName': 'Gogineni', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute of Emory University, Atlanta, GA.'}, {'ForeName': 'Xiaoxian', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Emory University, Atlanta, GA.'}, {'ForeName': 'Carlos S', 'Initials': 'CS', 'LastName': 'Moreno', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute of Emory University, Atlanta, GA; Department of Oncology, Sidney Kimmel Comprehensive Cancer Center of Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Zhengjia', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute of Emory University, Atlanta, GA; Department of Bioinformatics and Biostatistics Shared Resource, Winship Cancer Institute of Emory University, Atlanta, GA.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Kaklamani', 'Affiliation': 'Division of Hematology/Oncology, University of Texas Health Sciences Center, San Antonio, TX.'}, {'ForeName': 'Ruth M', 'Initials': 'RM', 'LastName': ""O'Regan"", 'Affiliation': 'Department of Medicine and Carbone Cancer Center, University of Wisconsin, Madison, WI. Electronic address: roregan@medicine.wisc.edu.'}]",Clinical breast cancer,['10.1016/j.clbc.2018.12.017']
1029,31609716,Effects of long-term vestibular rehabilitation therapy with vibrotactile sensory augmentation for people with unilateral vestibular disorders - A randomized preliminary study.,"BACKGROUND AND OBJECTIVE


This pilot study aimed to investigate the effects of incorporating vibrotactile sensory augmentation (SA) on balance performance among people with unilateral vestibular disorders (UVD).
METHODS


Eight participants with UVD were recruited. Participants completed 18 balance training sessions across six weeks in a clinical setting. Four participants (68.1±7.5 yrs) were randomized to the experimental group (EG) and received trunk-based vibrotactile SA while performing the balance exercises, and four participants (63.1±11.3 yrs) were assigned to the control group (CG); CG participants completed the balance training without SA. Clinical and kinematic balance performance measures were collected before training; midway through training; and one week, one month, and six months after training.
RESULTS


All participants, regardless of group, demonstrated improvements in a subset of the clinical or balance metrics immediately following completion of the balance training protocol. The EG showed significantly greater improvements than the CG for the Activities-specific Balance Confidence Scale and postural stability during the two standing balance exercises with head movements. The EG also had larger improvements than the CG for the Sensory Organization Test (SOT), Mini Balance Evaluations Systems Test, Gait Speed Test, Dynamic Gait Index, Functional Gait Assessment, and vestibular reliance metric calculated based on the SOT.
CONCLUSIONS


Incorporating vibrotactile SA into vestibular rehabilitation programs may lead to additional benefits that may be retained up to six months after training compared to training without vibrotactile SA. A larger study is warranted to demonstrate statistical significance between the groups.",2019,The EG showed significantly greater improvements than the CG for the Activities-specific Balance Confidence Scale and postural stability during the two standing balance exercises with head movements.,"['Eight participants with UVD were recruited', 'people with unilateral vestibular disorders (UVD', 'people with unilateral vestibular disorders', 'Four participants (68.1±7.5 yrs']","['trunk-based vibrotactile SA while performing the balance exercises', 'control group (CG); CG participants completed the balance training without SA', 'vibrotactile sensory augmentation (SA', 'long-term vestibular rehabilitation therapy', 'balance training sessions', 'vibrotactile sensory augmentation']","['Mini Balance Evaluations Systems Test, Gait Speed Test, Dynamic Gait Index, Functional Gait Assessment, and vestibular reliance metric calculated based on the SOT', 'Activities-specific Balance Confidence Scale and postural stability', 'balance performance', 'Clinical and kinematic balance performance measures']","[{'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C2609434', 'cui_str': 'Vestibular disorders (SMQ)'}]","[{'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C2919794', 'cui_str': 'Dynamic gait index (assessment scale)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2733457', 'cui_str': 'ABC (activities-specific balance confidence) scale'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",8.0,0.0214392,The EG showed significantly greater improvements than the CG for the Activities-specific Balance Confidence Scale and postural stability during the two standing balance exercises with head movements.,"[{'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Bao', 'Affiliation': 'Department of Mechanical Engineering, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Brooke N', 'Initials': 'BN', 'LastName': 'Klatt', 'Affiliation': 'Department of Physical Therapy, School of Health and Rehabilitation Sciences, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Carender', 'Affiliation': 'Otolaryngology, Michigan Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Kinnaird', 'Affiliation': 'Department of Mechanical Engineering, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Saud', 'Initials': 'S', 'LastName': 'Alsubaie', 'Affiliation': 'Department of Physical Therapy, School of Health and Rehabilitation Sciences, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Whitney', 'Affiliation': 'Department of Physical Therapy, School of Health and Rehabilitation Sciences, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Kathleen H', 'Initials': 'KH', 'LastName': 'Sienko', 'Affiliation': 'Department of Mechanical Engineering, University of Michigan, Ann Arbor, MI, USA.'}]",Journal of vestibular research : equilibrium & orientation,['10.3233/VES-190683']
1030,31536806,Menopausal Hormone Therapy and Risks of First Hospitalized Heart Failure and its Subtypes During the Intervention and Extended Postintervention Follow-up of the Women's Health Initiative Randomized Trials.,"BACKGROUND


We assessed whether postmenopausal hormone therapy (HT) was associated with incident heart failure (HF) and its subtypes and examined whether there was a modifying effect of age on the associations.
METHODS AND RESULTS


Postmenopausal women aged 50-79 enrolled in the Women's Health Initiative HT trials were analyzed. The 16,486 women with a uterus were randomized to receive conjugated equine estrogens (CEE 0.625 mg/day) plus medroxyprogesterone acetate (MPA 2.5 mg/day) or placebo, and 10,739 women with prior hysterectomy were randomized to receive CEE (0.625 mg/day) alone or placebo. Incident HF was defined as the first HF hospitalization. HF with reduced ejection fraction (HFrEF) or preserved EF (HFpEF) was defined as EF < 50% or ≥ 50%. During the intervention phase, median follow-up was 5.6 years in the CEE-plus-MPA trial and 7.2 years in the CEE-alone trial. During the cumulative follow-up of 18.9 years, women randomized to HT vs placebo in the 2 combined trials had incidence rates of 3.90 vs 3.89 per 1000 person-years for total HF; 1.25 vs 1.40 per 1000 person-years for HFrEF, and 1.88 vs 1.79 per 1000 person-years for HFpEF, respectively. There were no significant effects of HT on the risk of total incident HF or its subtypes in either trial, and age at randomization did not significantly modify the results.
CONCLUSIONS


Postmenopausal HT did not alter the risk of hospitalization for HF or its subtypes during the intervention or cumulative 18.9 years of follow-up, and results did not vary significantly by age at randomization.
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT0000611 https://clinicaltrials.gov/ct2/show/NCT00000611?cond=women%27s±health±initiative&rank=5.",2020,"There were no significant effects of HT on the risk of total incident HF or its subtypes in either trial, and age at randomization did not significantly modify the results.
","[""Postmenopausal women aged 50-79 enrolled in the Women's Health Initiative HT trials were analyzed"", '16,486 women with a uterus', '10,739 women with prior hysterectomy']","['HT vs. placebo', 'HT', 'postmenopausal hormone therapy (HT', 'CEE (0.625 mg/day) alone or placebo', 'conjugated equine estrogens (CEE 0.625 mg/day) plus medroxyprogesterone acetate (MPA 2.5 mg/day) or placebo']","['risk of total incident HF', 'risk of hospitalization for HF', 'incidence rates', 'HF with reduced ejection fraction (HFrEF) or preserved EF (HFpEF']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0080339', 'cui_str': 'Womens Health'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}, {'cui': 'C0042149', 'cui_str': 'Womb'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0046018', 'cui_str': 'CEES'}, {'cui': 'C4517467', 'cui_str': 'Zero point six two five'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0065864', 'cui_str': 'medroxyprogesterone acetate'}, {'cui': 'C3844011', 'cui_str': '2.5'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}]",79.0,0.223619,"There were no significant effects of HT on the risk of total incident HF or its subtypes in either trial, and age at randomization did not significantly modify the results.
","[{'ForeName': 'Longjian', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Epidemiology and Biostatistics, Dornsife School of Public Health, Drexel University, Philadelphia, PA. Electronic address: LL85@Drexel.edu.'}, {'ForeName': 'Liviu', 'Initials': 'L', 'LastName': 'Klein', 'Affiliation': 'Division of Cardiology, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Eaton', 'Affiliation': 'Department of Family Medicine, Alpert Medical School of Brown University, and Department of Epidemiology, Brown University School of Public Health, Providence, RI.'}, {'ForeName': 'Gurusher', 'Initials': 'G', 'LastName': 'Panjrath', 'Affiliation': 'George Washington University School of Medicine and Health Sciences, Washington, DC.'}, {'ForeName': 'Lisa Warsinger', 'Initials': 'LW', 'LastName': 'Martin', 'Affiliation': 'George Washington University School of Medicine and Health Sciences, Washington, DC.'}, {'ForeName': 'Claudia U', 'Initials': 'CU', 'LastName': 'Chae', 'Affiliation': 'Cardiology Division, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Greenland', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Donald M', 'Initials': 'DM', 'LastName': 'Lloyd-Jones', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Wactawski-Wende', 'Affiliation': 'Department of Epidemiology and Environmental Health, School of Public Health and Health Professions, University at Buffalo, Buffalo NY.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School and Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA.""}]",Journal of cardiac failure,['10.1016/j.cardfail.2019.09.006']
1031,31925579,"Flurbiprofen axetil for postoperative analgesia in upper abdominal surgery: a randomized, parallel controlled, double-blind, multicenter clinical study.","PURPOSE


To investigate the efficacy and safety of flurbiprofen axetil in postoperative analgesia in upper abdominal surgery.
METHODS


This was a multicenter, randomized, positive drug parallel controlled double-blind clinical study. Patients undergoing upper abdominal surgery were randomly divided to receive flurbiprofen axetil or tramadol. The VAS pain scores at rest and on coughing (pulmonary function training) were assessed immediately before drug usage (T1) to evaluate the efficacy of postoperative analgesia. Repeat assessment of the VAS was performed after T1. The timing of the recovery of the gastrointestinal function and the preoperative and postoperative IL-6, cortisol, and blood glucose levels were recorded as secondary endpoints. Vital signs and the occurrence of adverse reactions were evaluated for the assessment of safety.
RESULTS


A total of 240 patients were enrolled in the current study; 119 used flurbiprofen axetil for postoperative analgesia. The VAS scores at rest and on coughing did not differ between the two groups to a statistically significant extent (P > 0.05). However, the reduction of the VAS score at rest in the flurbiprofen axetil group was greater than that in the tramadol group at 4-24 h after T1. The reduction of the VAS score on coughing at 8 h after T1 was greater in the flurbiprofen axetil group. The incidence of adverse reactions was significantly lower in the flurbiprofen axetil group, with only one adverse reaction recorded. In contrast, 18 adverse reactions were reported in the tramadol group.
CONCLUSION


Flurbiprofen axetil showed superior efficacy to tramadol in early postoperative analgesia after upper abdominal surgery. Flurbiprofen axetil was associated with a significantly lower incidence of adverse reactions in comparison to tramadol.",2020,Flurbiprofen axetil showed superior efficacy to tramadol in early postoperative analgesia after upper abdominal surgery.,"['Patients undergoing upper abdominal surgery', '240 patients were enrolled in the current study; 119 used', 'early postoperative analgesia after upper abdominal surgery', 'upper abdominal surgery']","['flurbiprofen axetil or tramadol', 'flurbiprofen axetil', 'tramadol', 'Flurbiprofen axetil']","['adverse reactions', 'VAS pain scores at rest and on coughing (pulmonary function training', 'efficacy and safety', 'VAS scores at rest and on coughing', 'VAS score', 'VAS score on coughing', 'Vital signs and the occurrence of adverse reactions', 'incidence of adverse reactions', 'preoperative and postoperative IL-6, cortisol, and blood glucose levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]","[{'cui': 'C1610514', 'cui_str': 'flurbiprofen axetil'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0518766'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}]",240.0,0.0513386,Flurbiprofen axetil showed superior efficacy to tramadol in early postoperative analgesia after upper abdominal surgery.,"[{'ForeName': 'Run-Dong', 'Initials': 'RD', 'LastName': 'Wang', 'Affiliation': ""Department of General Surgery, Anhui No. 2 Provincial People's Hospital, Hefei, Anhui, People's Republic of China.""}, {'ForeName': 'Xu-Ren', 'Initials': 'XR', 'LastName': 'Sheng', 'Affiliation': ""Department of Liver Surgery, The First Affiliated Hospital of USTC, 17 Lujiang Road, Luyang, Hefei, Anhui, 230001, People's Republic of China.""}, {'ForeName': 'Wen-Xian', 'Initials': 'WX', 'LastName': 'Guan', 'Affiliation': ""Department of General Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, People's Republic of China.""}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ""Department of General Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, People's Republic of China.""}, {'ForeName': 'Chuang', 'Initials': 'C', 'LastName': 'Peng', 'Affiliation': ""Hepatological Surgery Department, Hunan Provincial People's Hospital, The First Hospital Affiliated with Hunan Normal University, Changsha, People's Republic of China.""}, {'ForeName': 'Yuan-Yuan', 'Initials': 'YY', 'LastName': 'Yang', 'Affiliation': ""The Basic Surgical, Union Hospital Affiliated with Fujian Medical University, Fuzhou, People's Republic of China.""}, {'ForeName': 'He-Guang', 'Initials': 'HG', 'LastName': 'Huang', 'Affiliation': ""The Basic Surgical, Union Hospital Affiliated with Fujian Medical University, Fuzhou, People's Republic of China.""}, {'ForeName': '', 'Initials': '', 'LastName': 'Ning-Li', 'Affiliation': ""Intestinal Microenvironment Treatment Center, Tenth People's Hospital of Tongji University, Shanghai, People's Republic of China.""}, {'ForeName': 'Wei-Dong', 'Initials': 'WD', 'LastName': 'Jia', 'Affiliation': ""Department of Liver Surgery, The First Affiliated Hospital of USTC, 17 Lujiang Road, Luyang, Hefei, Anhui, 230001, People's Republic of China. jwd19680@sina.com.""}]",Surgery today,['10.1007/s00595-019-01951-1']
1032,31939036,A comparative study between intradermal botulinum toxin A and fractional microneedle radiofrequency (FMR) for the treatment of primary axillary hyperhidrosis.,"Microneedle radiofrequency (FMR) for the treatment of primary axillary hyperhidrosis radiofrequency (RF) technology is a new modality that applied deep heat energy directly affecting the epidermis and dermis. Limiting data about FMR for axillary hyperhidrosis is concerning. To compare clinical efficacy between fractional microneedle radiofrequency and intradermal botulinum toxin type A injection. This study was a randomized, intraindividual split-side comparative study. Twenty female subjects clinically diagnosed of primary axillary hyperhidrosis were enrolled. All subjects randomly assigned to receive either FMR device on one side of axilla or 50 units of intradermal botulinum toxin A on contralateral side of axilla. Treatment with FMR device was scheduled for 2 sessions for 4 weeks apart. After treatment, mean Hyperhidrosis Disease Severity Score (HDSS) of both groups revealed remarkably better reduction from the baseline (p < 000.1). By comparing between the two groups at the endpoint visit (12th week), the botulinum toxin A group had significantly better reduction of mean HDSS score than the microneedle RF group with 1.60 (0.59) versus 2.05 (0.68), respectively (p = 0.0332). At the week-12 visit, the botulinum toxin A group had significantly better participant's satisfaction score by quartile rating scale than the microneedle RF group (2.55 + 0.69 versus 1.70 + 1.03, respectively, p = 0.004). Therefore, the botulinum toxin A group also demonstrated with significantly better improvement for their quality of life by DLQI score at the 12th week than the microneedle RF group (p = 0.013). Intradermal botulinum toxin A had better efficacy than fractional microneedle radiofrequency for the treatment of primary axillary hyperhidrosis.",2020,Intradermal botulinum toxin A had better efficacy than fractional microneedle radiofrequency for the treatment of primary axillary hyperhidrosis.,"['primary axillary hyperhidrosis', 'Twenty female subjects clinically diagnosed of primary axillary hyperhidrosis were enrolled']","['Microneedle radiofrequency (FMR', 'microneedle RF', 'fractional microneedle radiofrequency and intradermal botulinum toxin type A injection', 'FMR device on one side of axilla or 50\xa0units of intradermal botulinum toxin A on contralateral side of axilla', 'FMR device', 'Intradermal botulinum toxin', 'intradermal botulinum toxin A and fractional microneedle radiofrequency (FMR', 'fractional microneedle radiofrequency']","['mean Hyperhidrosis Disease Severity Score (HDSS', ""participant's satisfaction score by quartile rating scale"", 'mean HDSS score', 'quality of life by DLQI score']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C0020458', 'cui_str': 'Hyperhidrosis'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C4060200', 'cui_str': 'Botulinum Toxin Type A Injection [Botox]'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0006055', 'cui_str': 'Botulin'}, {'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0020458', 'cui_str': 'Hyperhidrosis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0034380'}]",20.0,0.0242862,Intradermal botulinum toxin A had better efficacy than fractional microneedle radiofrequency for the treatment of primary axillary hyperhidrosis.,"[{'ForeName': 'Paisal', 'Initials': 'P', 'LastName': 'Rummaneethorn', 'Affiliation': 'School of Antiaging and Regenerative Medicine, Mae Fah Luang University, 38/11-13 Asoke place building, Asoke road, Sukhumvit 21, Wattana, North Klongtoey, Bangkok, Thailand.'}, {'ForeName': 'Thep', 'Initials': 'T', 'LastName': 'Chalermchai', 'Affiliation': 'School of Antiaging and Regenerative Medicine, Mae Fah Luang University, 38/11-13 Asoke place building, Asoke road, Sukhumvit 21, Wattana, North Klongtoey, Bangkok, Thailand. thep_chalermchai@hotmail.com.'}]",Lasers in medical science,['10.1007/s10103-020-02958-8']
1033,31943761,The effect of a combined intervention on exclusive breastfeeding in primiparas: A randomised controlled trial.,"An antenatal/postnatal intervention involving proactive telephone support and written materials was conducted among primiparas. Four hundred women, from the Split-Dalmatia County, Croatia, were randomized between November 2013 and December 2016 into three groups: intervention (IG), active control (ACG) and standard care (SCG). Primary outcome was exclusive breastfeeding (EBF) at 3 months. Secondary outcomes included breastfeeding difficulties, attitudes towards infant feeding, breastfeeding self-efficacy and social support. Practice staff were blinded to group allocation. Of 400 women, 45 (11%) were lost to follow-up, and final analyses were conducted on 129 (IG), 103 (ACG) and 123 (SCG) participants. EBF rates at 3 months were significantly higher for the IG (odds ratio [OR] 4.6, 95% confidence interval [CI], 2.7 to 8.1; EBF 81%) as well as at 6 months (OR 15.7, 95% CI, 9.1 to 27.1; EBF 64%) compared with SCG (EBF 47% at 3 months and 3% at 6 months). Higher rates were also observed for the ACG at 3 months (OR 2.2, 95% CI, 1.3 to 3.8, EBF 68%) and 6 months (OR 2.3, 95% CI, 1.4 to 3.9, EBF 16%). Participants in the IG had the highest increase in positive attitudes towards infant feeding, in comparison to baseline, and significantly higher breastfeeding self-efficacy. Participants in SCG experienced significantly more breastfeeding difficulties, both at 3 and 6 months, in comparison to AC and IGs. Written breastfeeding materials and proactive telephone support among primiparas are an effective means of increasing breastfeeding rates, decreasing breastfeeding difficulties and improving self-efficacy and attitudes towards infant feeding.",2020,"Participants in SCG experienced significantly more breastfeeding difficulties, both at 3 and 6 months, in comparison to AC and IGs.","['primiparas', 'Four hundred women, from the Split-Dalmatia County, Croatia, were randomized between November 2013 and December 2016 into three groups', 'Of 400 women, 45 (11%) were lost to follow-up, and final analyses were conducted on 129 (IG), 103 (ACG) and 123 (SCG) participants']","['proactive telephone support and written materials', 'intervention (IG), active control (ACG) and standard care (SCG', 'combined intervention']","['exclusive breastfeeding (EBF', 'positive attitudes towards infant feeding', 'breastfeeding difficulties', 'breastfeeding difficulties, attitudes towards infant feeding, breastfeeding self-efficacy and social support', 'breastfeeding self-efficacy', 'EBF rates', 'breastfeeding difficulties and improving self-efficacy and attitudes towards infant feeding']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0012694', 'cui_str': 'Cromolyn Sodium'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}, {'cui': 'C0237428', 'cui_str': 'Optimism'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1998999', 'cui_str': 'Difficulty performing breast-feeding (finding)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0037438'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",400.0,0.0732465,"Participants in SCG experienced significantly more breastfeeding difficulties, both at 3 and 6 months, in comparison to AC and IGs.","[{'ForeName': 'Drita', 'Initials': 'D', 'LastName': 'Puharić', 'Affiliation': 'Postgraduate Doctoral Program ""TRIBE,"" School of Medicine, University of Split, Split, Croatia.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Malički', 'Affiliation': 'Department of Research in Biomedicine and Health, Department of Medical Humanities, School of Medicine, University of Split, Split, Croatia.'}, {'ForeName': 'Josip Anđelo', 'Initials': 'JA', 'LastName': 'Borovac', 'Affiliation': 'Department of Pathophysiology, School of Medicine, University of Split, Split, Croatia.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Šparac', 'Affiliation': 'Medical Centre ""Šparac"", Split, Croatia.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Poljak', 'Affiliation': '""Cito"" Medical Centre, Split, Croatia.'}, {'ForeName': 'Nađa', 'Initials': 'N', 'LastName': 'Aračić', 'Affiliation': '""Cito"" Medical Centre, Split, Croatia.'}, {'ForeName': 'Nero', 'Initials': 'N', 'LastName': 'Marinović', 'Affiliation': 'Split-Dalmatiani County Health Department, Omiš, Croatia.'}, {'ForeName': 'Nives', 'Initials': 'N', 'LastName': 'Luetić', 'Affiliation': 'Split-Dalmatian County Health Department, Split, Croatia.'}, {'ForeName': 'Irena', 'Initials': 'I', 'LastName': 'Zakarija-Grković', 'Affiliation': 'Departments of Clinical Skills and Family Medicine, School of Medicine, University of Split, Split, Croatia.'}]",Maternal & child nutrition,['10.1111/mcn.12948']
1034,31926597,Evaluation of emergence agitation after general anaesthesia in rhinoplasty patients: Inhalation anaesthesia versus total intravenous anaesthesia.,"BACKGROUND


Emergence agitation (EA) is a clinical condition that occurs early in recovery from general anaesthesia, and reduces patient comfort. The aim of this study was to compare the effects of low-flow sevoflurane anaesthesia and total intravenous anaesthesia (TIVA) on agitation in rhinoplasty patients, and to determine the frequency of EA in low flow sevoflurane anaesthesia after rhinoplasty.
MATERIAL AND METHODS


A total of 90 rhinoplasty patients, under general anaesthesia were included in this prospective randomised study. After induction of anaesthesia, propofol infusion was initiated in the TIVA group (n = 45), and sevoflurane was administered in the SEVO group with a fresh gas flow of 1 l/min and MAC (minimum alveolar concentration) 1-1.1 (n = 45). Early emergence times, Richmond agitation-sedation scale (RASS), Boezaart scale, Likert scale and incidences of nausea/vomiting were recorded at the end of surgery.
RESULTS


Early emergence time was significantly shorter in the TIVA group, than in the SEVO group (p < 0.001). İntraoperative bleeding was significantly lower in the TIVA group, than in the SEVO group (p = 0.005), and surgical field image quality and surgeon satisfaction were better in the TIVA group (p = 0.016, p < 0.001). The ratio of patients with RASS > +1 for all patients was 35.6% at 0 min, postoperatively. This rate was 12.2% (n = 11) in the TIVA group, and 23.3% (n = 21) in the SEVO group (p = 0.028).
CONCLUSIONS


In rhinoplasty, TIVA caused shorter early emergence times, less bleeding, high surgeon satisfaction, and lower EA scores when compared with low flow sevoflurane anaesthesia.",2020,"İntraoperative bleeding was significantly lower in the TIVA group, than in the SEVO group (p = 0.005), and surgical field image quality and surgeon satisfaction were better in the TIVA group (p = 0.016, p < 0.001).","['90 rhinoplasty patients, under general anaesthesia', 'rhinoplasty patients']","['sevoflurane', 'anaesthesia, propofol infusion', 'anaesthesia versus total intravenous anaesthesia', 'low-flow sevoflurane anaesthesia and total intravenous anaesthesia (TIVA']","['Early emergence times, Richmond agitation-sedation scale (RASS), Boezaart scale, Likert scale and incidences of nausea/vomiting', 'surgical field image quality and surgeon satisfaction', 'bleeding, high surgeon satisfaction, and lower EA scores', 'İntraoperative bleeding']","[{'cui': 'C0035467', 'cui_str': 'Plastic operation on nose'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia (procedure)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3854651', 'cui_str': 'TIVA'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}, {'cui': 'C0222045'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0313933,"İntraoperative bleeding was significantly lower in the TIVA group, than in the SEVO group (p = 0.005), and surgical field image quality and surgeon satisfaction were better in the TIVA group (p = 0.016, p < 0.001).","[{'ForeName': 'Gamze', 'Initials': 'G', 'LastName': 'Talih', 'Affiliation': 'Department of Anaesthesiology, Faculty of Medicine, Bozok University, Yozgat, Turkey. Electronic address: gamzetalih@gmail.com.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Yüksek', 'Affiliation': 'Department of Anaesthesiology, Faculty of Medicine, Bozok University, Yozgat, Turkey.'}, {'ForeName': 'Ender', 'Initials': 'E', 'LastName': 'Şahin', 'Affiliation': 'Department of Otolaryngology, Faculty of Medicine, Bozok University Yozgat, Turkey.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102387']
1035,31942918,Efficacy of an m-Health Physical Activity and Sleep Intervention to Improve Sleep Quality in Middle-Aged Adults: The Refresh Study Randomized Controlled Trial.,"BACKGROUND


Poor sleep health is highly prevalent. Physical activity is known to improve sleep quality but not specifically targeted in sleep interventions.
PURPOSE


To compare the efficacy of a combined physical activity and sleep intervention with a sleep-only intervention and a wait-list control, for improving sleep quality in middle-aged adults without a diagnosed sleep disorder.
METHODS


Three-arm randomized controlled trial (Physical Activity and Sleep Health (PAS), Sleep Health Only (SO), Wait-list Control (CON) groups; 3-month primary time-point, 6-month follow-up) of 275 (PAS = 110, SO = 110, CON = 55) inactive adults (40-65 years) reporting poor sleep quality. The main intervention component was a smartphone/tablet ""app"" to aid goal setting and self-monitoring physical activity and/or sleep hygiene behaviors (including stress management), and a pedometer for PAS group. Primary outcome was Pittsburgh Sleep Quality Index (PSQI) global score. Secondary outcomes included several self-reported physical activity measures and PSQI subcomponents. Group differences were examined stepwise, first between pooled intervention (PI = PAS + SO) and CON groups, then between PAS and SO groups.
RESULTS


Compared with CON, PI groups significantly improved PSQI global and subcomponents scores at 3 and 6 months. There were no differences in sleep quality between PAS and SO groups. The PAS group reported significantly less daily sitting time at 3 months and was significantly more likely to report ≥2 days/week resistance training and meeting physical activity guidelines at 6 months than the SO group.
CONCLUSIONS


PIs had statistically significantly improved sleep quality among middle-aged adults with poor sleep quality without a diagnosed sleep disorder. The adjunctive physical activity intervention did not additionally improve sleep quality.
CLINICAL TRIAL INFORMATION


Australian New Zealand Clinical Trial Registry: ACTRN12617000680369; Universal Trial number: U1111-1194-2680; Human Research Ethics Committee, Blinded by request of journal: H-2016-0267.",2020,"The PAS group reported significantly less daily sitting time at 3 months and was significantly more likely to report ≥2 days/week resistance training and meeting physical activity guidelines at 6 months than the SO group.
","['Australian New Zealand Clinical Trial Registry', 'middle-aged adults with poor sleep quality without a diagnosed sleep disorder', 'middle-aged adults without a diagnosed sleep disorder', 'Middle-Aged Adults']","['combined physical activity and sleep intervention with a sleep-only intervention and a wait-list control', 'm-Health Physical Activity and Sleep Intervention', 'Physical Activity and Sleep Health (PAS), Sleep Health Only (SO', 'adjunctive physical activity intervention', 'Wait-list Control (CON', 'smartphone/tablet ""app"" to aid goal setting and self-monitoring physical activity and/or sleep hygiene behaviors (including stress management), and a pedometer for PAS group', 'CON']","['Pittsburgh Sleep Quality Index (PSQI) global score', 'poor sleep quality', 'Sleep Quality', 'several self-reported physical activity measures and PSQI subcomponents', 'sleep quality', 'PSQI global and subcomponents scores', 'daily sitting time']","[{'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}, {'cui': 'C0150598', 'cui_str': 'Goal setting (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C4277672', 'cui_str': 'Sleep Hygiene'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.106602,"The PAS group reported significantly less daily sitting time at 3 months and was significantly more likely to report ≥2 days/week resistance training and meeting physical activity guidelines at 6 months than the SO group.
","[{'ForeName': 'Anna T', 'Initials': 'AT', 'LastName': 'Rayward', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Medicine & Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Murawski', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Medicine & Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Mitch J', 'Initials': 'MJ', 'LastName': 'Duncan', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Medicine & Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Elizabeth G', 'Initials': 'EG', 'LastName': 'Holliday', 'Affiliation': 'School of Medicine & Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Corneel', 'Initials': 'C', 'LastName': 'Vandelanotte', 'Affiliation': 'Physical Activity Research Group, School for Health, Medical and Applied Sciences, Central Queensland University, Rockhampton, Queensland, Australia.'}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Brown', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Ronald C', 'Initials': 'RC', 'LastName': 'Plotnikoff', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Education, University of Newcastle, Callaghan, New South Wales, Australia.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaz064']
1036,31942927,Inulin-type fructan intervention restricts the increase in gut microbiome-generated indole in patients with peritoneal dialysis: a randomized crossover study.,"BACKGROUND


Indoxyl sulfate (IS) and p-cresyl sulfate (pCS), 2 important protein-bound uremic toxins, are independent risk factors for cardiovascular disease in patients with end-stage renal disease. Indole and p-cresol are gut microbiome-generated precursors of IS and pCS.
OBJECTIVE


The aim of the present study was to determine whether inulin-type fructans (ITFs) reduce the production of indole and p-cresol by altering their producing bacteria in patients with peritoneal dialysis.
METHODS


Patients receiving peritoneal dialysis for >3 mo without diabetes and not using antibiotics were recruited to a randomized, double-blind, placebo-controlled, crossover trial of ITF intervention over 36 wk (12-wk washout). The primary outcomes were gut microbiome, fecal indole and p-cresol, indole-producing bacteria, p-cresol-producing bacteria, and serum IS and pCS. The secondary outcomes were fecal pH, 24-h urine, and dialysis removal of IS and pCS.
RESULTS


Of 21 individuals randomly assigned, 15 completed the study. The daily nutrient intakes, including protein, tryptophan, and tyrosine, were isostatic during the prebiotic, washout, and placebo intervention. There were no baseline differences in the outcomes of interest between treatments. For fecal indole, its concentrations did not change significantly in either treatment. However, there was a trend toward the treatment-by-time effect (P = 0.052), with a quantitative reduction in the ITF treatment and an increase in the control. The difference in the changes between the 2 treatments was significant (-10.07 ± 7.48 μg/g vs +13.35 ± 7.66 μg/g; P = 0.040). Similar to Bacteroides thetaiotaomicron, there was a difference over time between the 2 treatments, with a significant treatment and time interaction effect (P = 0.047). There were no treatment, time, or interaction effects for fecal p-cresol, serum IS and pCS, 24-h urine, and dialysis removal of IS and pCS.
CONCLUSIONS


Our results suggested that ITFs restricted the increase in gut microbiome-generated indole in patients with peritoneal dialysis. This trial was registered at http://www.chictr.org.cn/showproj.aspx?proj=21228 as ChiCTR-INR-17013739.",2020,"There were no treatment, time, or interaction effects for fecal p-cresol, serum IS and pCS, 24-h urine, and dialysis removal of IS and pCS.
","['Patients receiving peritoneal dialysis for >3 mo without diabetes and not using antibiotics', 'patients with peritoneal dialysis', 'patients with end-stage renal disease', '21 individuals randomly assigned']","['placebo', 'inulin-type fructans (ITFs', 'ITF intervention', 'Inulin-type fructan intervention', 'placebo intervention', 'Indoxyl sulfate (IS) and p-cresyl sulfate (pCS']","['gut microbiome, fecal indole and p-cresol, indole-producing bacteria, p-cresol-producing bacteria, and serum IS and pCS', 'time, or interaction effects for fecal p-cresol, serum IS and pCS, 24-h\xa0urine, and dialysis removal of IS and pCS', 'daily nutrient intakes, including protein, tryptophan, and tyrosine', 'fecal pH, 24-h\xa0urine, and dialysis removal of IS and pCS', 'time interaction effect']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal Dialysis'}, {'cui': 'C0445107', 'cui_str': 'Not used (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0016743', 'cui_str': 'Levans'}, {'cui': 'C0021210', 'cui_str': 'Indoxyl Sulfate'}, {'cui': 'C0038720', 'cui_str': 'Sulfates, Inorganic'}]","[{'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0021242', 'cui_str': 'Indoles'}, {'cui': 'C0048212', 'cui_str': 'para-cresol'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0041249', 'cui_str': 'L-tryptophan'}, {'cui': 'C0041485', 'cui_str': 'L-tyrosine'}, {'cui': 'C2711455', 'cui_str': 'pH of stool'}]",15.0,0.121454,"There were no treatment, time, or interaction effects for fecal p-cresol, serum IS and pCS, 24-h urine, and dialysis removal of IS and pCS.
","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Nutrition and Food Hygiene, Hubei Key Laboratory of Food Nutrition and Safety, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Xiong', 'Affiliation': 'Department of Nutrition and Food Hygiene, Hubei Key Laboratory of Food Nutrition and Safety, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Nutrition and Food Hygiene, Hubei Key Laboratory of Food Nutrition and Safety, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xuechun', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'Department of Nutrition and Food Hygiene, Hubei Key Laboratory of Food Nutrition and Safety, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Shuiqin', 'Initials': 'S', 'LastName': 'He', 'Affiliation': 'Department of Nutrition and Food Hygiene, Hubei Key Laboratory of Food Nutrition and Safety, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Nannan', 'Initials': 'N', 'LastName': 'Wu', 'Affiliation': 'Department of Nutrition and Food Hygiene, Hubei Key Laboratory of Food Nutrition and Safety, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Department of Clinical Nutrition, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Wangqun', 'Initials': 'W', 'LastName': 'Liang', 'Affiliation': 'Division of Nephrology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xuezhi', 'Initials': 'X', 'LastName': 'Zuo', 'Affiliation': 'Department of Clinical Nutrition, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Chenjiang', 'Initials': 'C', 'LastName': 'Ying', 'Affiliation': 'Department of Nutrition and Food Hygiene, Hubei Key Laboratory of Food Nutrition and Safety, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqz337']
1037,31937442,Kinesiotaping for isolated rib fractures in emergency department.,"INTRODUCTION


Rib fractures, which are among the most common injuries in blunt thoracic trauma, are usually encountered in Emergency Departments. Kinesiotape (KT) is a drug-free elastic therapeutic tape used for treating various musculoskeletal problems such as injury, dysfunction and pain. We aimed to investigate whether kinesotaping should be used safely and effectively in rib fractures in emergency setting.
MATERIALS AND METHODS


This was a prospective, randomized controlled study conducted in an Emergency Department of a University Hospital. Patients diagnosed with isolated rib fractures were included in the study. Pain severity of patients assessed with 0-10 cm visual analog scale (VAS), then patients assigned into 2 treatment groups. One of them received treatment with flurbiprofen 200 mg/day and the other group received kinesiotaping in addition to the same oral therapy. On the 4th day of the procedure, both groups were assessed with VAS in the followup visit.
RESULTS


Total of 82 patients presented with rib fractures, 52 of them were excluded. Remaining 30 constituted the study group and randomly allocated to kinesiotaping (n = 16) or control group (n = 14). In both groups, pain intensity on the 4th day was significantly reduced when compared with baseline (p for both<0.01). Additionally, considering the reducing the pain intensity on 4th day, kinesiotaping was significantly superior than the control group (p < 0.01).
CONCLUSION


This study investigated the use of kinesiotaping in emergency departments. When compared to NSAID therapy alone, combined kinesiotaping and NSAID therapy appears to be more effective in terms of pain reduction in rib fractures.",2020,"Additionally, considering the reducing the pain intensity on 4th day, kinesiotaping was significantly superior than the control group (p < 0.01).
","['rib fractures in emergency setting', 'emergency departments', 'Total of 82 patients presented with rib fractures, 52 of them were excluded', 'Patients diagnosed with isolated rib fractures', 'isolated rib fractures in emergency department', 'Emergency Department of a University Hospital']","['NSAID therapy alone, combined kinesiotaping and NSAID therapy', 'Kinesiotape (KT', 'flurbiprofen']","['pain reduction', 'pain intensity', 'Pain severity']","[{'cui': 'C0035522', 'cui_str': 'Rib Fractures'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C0016377', 'cui_str': 'Flurbiprofen'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",82.0,0.0341479,"Additionally, considering the reducing the pain intensity on 4th day, kinesiotaping was significantly superior than the control group (p < 0.01).
","[{'ForeName': 'Ali Haydar', 'Initials': 'AH', 'LastName': 'Akça', 'Affiliation': 'Yüzüncü Yıl University, Faculty of Medicine, Department of Emergency Medicine, Turkey.'}, {'ForeName': 'Muhammed İkbal', 'Initials': 'Mİ', 'LastName': 'Şaşmaz', 'Affiliation': 'Manisa Celal Bayar University, Faculty of Medicine, Department of Emergency Medicine, Turkey. Electronic address: ikbalsasmaz@hotmail.com.'}, {'ForeName': 'Şeyhmus', 'Initials': 'Ş', 'LastName': 'Kaplan', 'Affiliation': 'Yüzüncü Yıl University, Faculty of Medicine, Department of Sports Medicine, Turkey.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.11.049']
1038,31567674,A Multicenter Randomized Controlled Trial Evaluating the Effectiveness of Cognitive Training for Anterior Approach Total Hip Arthroplasty.,"BACKGROUND


For total hip arthroplasty (THA), cognitive training prior to performing real surgery may be an effective adjunct alongside simulation to shorten the learning curve. This study sought to create a cognitive training tool (CTT) to perform anterior approach (AA)-THA, which was validated by expert surgeons, and test its use as a training tool compared with conventional material.
METHODS


We employed a modified Delphi method with 4 expert surgeons from 3 international centers of excellence. Surgeons were independently observed performing THA before undergoing semistructured cognitive task analysis (CTA) and before completing successive rounds of surveys until a consensus was reached. Thirty-six surgical residents (postgraduate year [PGY]-1 through PGY-4) were randomized to cognitive training or training with a standard operation manual with surgical videos before performing a simulated AA-THA.
RESULTS


The consensus CTA defined THA in 11 phases, in which were embedded 46 basic steps, 36 decision points, and 42 critical errors and linked strategies. This CTA was mapped onto an open-access web-based CTT. Surgeons who prepared with the CTT performed a simulated THA 35% more quickly (time, mean 28 versus 38 minutes) with 69% fewer errors in instrument selection (mean 29 versus 49 instances), and required 92% fewer prompts (mean 13 versus 25 instances). They were more accurate in acetabular cup orientation (inclination error, mean 8° versus 10°; anteversion error, mean 14° versus 22°).
CONCLUSIONS


This validated CTT for arthroplasty provides structure for competency-based learning. It is more effective at preparing orthopaedic trainees for a complex procedure than conventional materials, as well as for learning sequence, instrumentation utilization, and motor skills.
CLINICAL RELEVANCE


Cognitive training combines education on decision-making, knowledge, and technical skill. It is an inexpensive technique to teach surgeons to perform hip arthroplasty and is more effective than current preparation methods.",2020,"Surgeons who prepared with the CTT performed a simulated THA 35% more quickly (time, mean 28 versus 38 minutes) with 69% fewer errors in instrument selection (mean 29 versus 49 instances), and required 92% fewer prompts (mean 13 versus 25 instances).","['Thirty-six surgical residents (postgraduate year [PGY]-1 through PGY-4', 'Anterior Approach Total Hip Arthroplasty', '4 expert surgeons from 3 international centers of excellence']","['cognitive training tool (CTT', 'total hip arthroplasty (THA), cognitive training', 'Cognitive Training', 'cognitive training or training with a standard operation manual with surgical videos before performing a simulated AA-THA']",['acetabular cup orientation'],"[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205511', 'cui_str': 'Anterior approach (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0642413', 'cui_str': 'THAS'}]","[{'cui': 'C2949743', 'cui_str': 'Cup - unit of product usage'}, {'cui': 'C0029266', 'cui_str': 'Cognitive Orientation'}]",36.0,0.0561386,"Surgeons who prepared with the CTT performed a simulated THA 35% more quickly (time, mean 28 versus 38 minutes) with 69% fewer errors in instrument selection (mean 29 versus 49 instances), and required 92% fewer prompts (mean 13 versus 25 instances).","[{'ForeName': 'Kartik', 'Initials': 'K', 'LastName': 'Logishetty', 'Affiliation': 'The MSk Lab, Department of Surgery and Cancer, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Wade T', 'Initials': 'WT', 'LastName': 'Gofton', 'Affiliation': 'Division of Orthopaedic Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'Branavan', 'Initials': 'B', 'LastName': 'Rudran', 'Affiliation': 'The MSk Lab, Department of Surgery and Cancer, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Beaulé', 'Affiliation': 'Division of Orthopaedic Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'Chinmay M', 'Initials': 'CM', 'LastName': 'Gupte', 'Affiliation': 'The MSk Lab, Department of Surgery and Cancer, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Justin P', 'Initials': 'JP', 'LastName': 'Cobb', 'Affiliation': 'The MSk Lab, Department of Surgery and Cancer, Imperial College London, London, United Kingdom.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.00121']
1039,30928294,Rationale and Study Design for an Individualized Perioperative Open Lung Ventilatory Strategy in Patients on One-Lung Ventilation (iPROVE-OLV).,"OBJECTIVE


The aim of this clinical trial is to examine whether it is possible to reduce postoperative complications using an individualized perioperative ventilatory strategy versus using a standard lung-protective ventilation strategy in patients scheduled for thoracic surgery requiring one-lung ventilation.
DESIGN


International, multicenter, prospective, randomized controlled clinical trial.
SETTING


A network of university hospitals.
PARTICIPANTS


The study comprises 1,380 patients scheduled for thoracic surgery.
INTERVENTIONS


The individualized group will receive intraoperative recruitment maneuvers followed by individualized positive end-expiratory pressure (open lung approach) during the intraoperative period plus postoperative ventilatory support with high-flow nasal cannula, whereas the control group will be managed with conventional lung-protective ventilation.
MEASUREMENTS AND MAIN RESULTS


Individual and total number of postoperative complications, including atelectasis, pneumothorax, pleural effusion, pneumonia, acute lung injury; unplanned readmission and reintubation; length of stay and death in the critical care unit and in the hospital will be analyzed for both groups. The authors hypothesize that the intraoperative application of an open lung approach followed by an individual indication of high-flow nasal cannula in the postoperative period will reduce pulmonary complications and length of hospital stay in high-risk surgical patients.",2019,"The individualized group will receive intraoperative recruitment maneuvers followed by individualized positive end-expiratory pressure (open lung approach) during the intraoperative period plus postoperative ventilatory support with high-flow nasal cannula, whereas the control group will be managed with conventional lung-protective ventilation.
","['high-risk surgical patients', 'Patients on One-Lung Ventilation (iPROVE-OLV', '1,380 patients scheduled for thoracic surgery', 'A network of university hospitals', 'patients scheduled for thoracic surgery requiring one-lung ventilation']","['standard lung-protective ventilation strategy', 'intraoperative recruitment maneuvers followed by individualized positive end-expiratory pressure (open lung approach) during the intraoperative period plus postoperative ventilatory support with high-flow nasal cannula, whereas the control group will be managed with conventional lung-protective ventilation']","['Individual and total number of postoperative complications, including atelectasis, pneumothorax, pleural effusion, pneumonia, acute lung injury; unplanned readmission and reintubation; length of stay and death in the critical care unit and in the hospital', 'pulmonary complications and length of hospital stay']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0559312', 'cui_str': 'Single-Lung Ventilation'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0039986', 'cui_str': 'Thoracic Surgery'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C3494516', 'cui_str': 'Positive end expiratory pressure (observable entity)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0021891', 'cui_str': 'Intraoperative Period'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0004144', 'cui_str': 'Lung Collapse'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0032227', 'cui_str': 'Pleural Effusion'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0242488', 'cui_str': 'Acute Lung Injury'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0010337', 'cui_str': 'Critical Care'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",1380.0,0.0832734,"The individualized group will receive intraoperative recruitment maneuvers followed by individualized positive end-expiratory pressure (open lung approach) during the intraoperative period plus postoperative ventilatory support with high-flow nasal cannula, whereas the control group will be managed with conventional lung-protective ventilation.
","[{'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Carramiñana', 'Affiliation': 'Department of Anesthesia and Critical Care, Hospital Clínic i Provincial, Barcelona, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ferrando', 'Affiliation': 'Department of Anesthesia and Critical Care, Hospital Clínic i Provincial, Barcelona, Spain; CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain. Electronic address: cafeornaestesia@gmail.com.'}, {'ForeName': 'M Carmen', 'Initials': 'MC', 'LastName': 'Unzueta', 'Affiliation': 'Department of Anesthesia and Critical Care, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Ricard', 'Initials': 'R', 'LastName': 'Navarro', 'Affiliation': 'Department of Anesthesia and Critical Care, Hospital Clínic i Provincial, Barcelona, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Suárez-Sipmann', 'Affiliation': 'CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain; Intensive Care Unit, Hospital de La Princesa, Madrid, Spain; Hedenstierna Laboratory, Department of Surgical Sciences, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Tusman', 'Affiliation': 'Department of Anesthesia, Hospital Privado de Mar de Plata, Mar de Plata, Argentina.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Garutti', 'Affiliation': 'Department of Anesthesia and Critical Care, Hospital Universitario Gregorio Marañon, Madrid, Spain.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Soro', 'Affiliation': 'Department of Anesthesia and Critical Care, Hospital Clínico of Valencia, Valencia, Spain.'}, {'ForeName': 'Natividad', 'Initials': 'N', 'LastName': 'Pozo', 'Affiliation': 'Institute INCLIVA, Hospital Clinico Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Julián', 'Initials': 'J', 'LastName': 'Librero', 'Affiliation': 'Navarrabiomed-Fundación Miguel Servet, Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Pamplona, Spain.'}, {'ForeName': 'Lucía', 'Initials': 'L', 'LastName': 'Gallego', 'Affiliation': 'Department of Anesthesia and Critical Care, Hospital Miguel Servet, Zaragoza, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Ramasco', 'Affiliation': 'Department of Anesthesia and Critical Care, Hospital La Princesa, Madrid, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Rabanal', 'Affiliation': 'Department of Anesthesia and Critical Care, Hospital Marqués de Valdecilla, Santander, Spain.'}, {'ForeName': 'Aurelio', 'Initials': 'A', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Anesthesia, Hospital Universitario Dr. Negrín, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Sastre', 'Affiliation': 'Department of Anesthesia and Critical Care t, Hospital de Salamanca, Salamanca, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Martinez', 'Affiliation': 'Department of Anesthesia and Critical Care, Hospital Universitari Mutua of Terrassa, Terrassa, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Coves', 'Affiliation': 'Department of Anesthesia and Critical Care, Hospital Univeristari de Vinalopó, Elche, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'García', 'Affiliation': 'Department of Anesthesia and Critical Care, Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Aguirre-Puig', 'Affiliation': 'Department of Anesthesia and Critical Care, Hospital Álvaro Cunqueiro, Vigo, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Yepes', 'Affiliation': 'Department of Anesthesia and Critical Care, Clínica Universitaria Pamplona, Spain.'}, {'ForeName': 'Aitana', 'Initials': 'A', 'LastName': 'Lluch', 'Affiliation': 'Department of Anesthesia and Critical Care, Hospital Universitario La Fe, Valencia, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'López-Herrera', 'Affiliation': 'Department of Anesthesia and Critical Care, Hospital Vírgen del Rocio, Sevilla, Spain.'}, {'ForeName': 'Sonsoles', 'Initials': 'S', 'LastName': 'Leal', 'Affiliation': 'Department of Anesthesia and Critical Care, Hospital Povisa, Vigo, Spain.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Vives', 'Affiliation': 'Department of Anesthesia and Critical Care, Hospital Dr. Josep Trueta, Girona, Spain.'}, {'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'Bellas', 'Affiliation': 'Department of Anesthesia and Critical Care, Fundación Jiménez Díaz, Madrid, Spain.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Socorro', 'Affiliation': 'Department of Anesthesia, Complejo Universitario Materno-Insular, Las Palmas, Spain.'}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Trespalacios', 'Affiliation': 'Department of Anesthesia and Critical Care, Hospital Universitario Central de Asturias, Oviedo, Spain.'}, {'ForeName': 'Claudia J', 'Initials': 'CJ', 'LastName': 'Salazar', 'Affiliation': 'Department of Anesthesia and Critical Care, Hospital Universitario de Canarias, Tenerife, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Mugarra', 'Affiliation': 'Department of Anesthesia and Critical Care, Hospital Clínico of Valencia, Valencia, Spain.'}, {'ForeName': 'Gilda', 'Initials': 'G', 'LastName': 'Cinnella', 'Affiliation': 'Department of Anesthesia and Critical Care, Università di Foggia, Foggia, Italy.'}, {'ForeName': 'Savino', 'Initials': 'S', 'LastName': 'Spadaro', 'Affiliation': 'Department of Anesthesia and Critical Care, Università di Ferrara, Ferrara, Italy.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Futier', 'Affiliation': 'Anesthesia and Critical Care, Centre Hospitalier Universitaire, Clermont-Ferrand, France.'}, {'ForeName': 'Leopoldo', 'Initials': 'L', 'LastName': 'Ferrer', 'Affiliation': 'Department of Anesthesia, Universidad El Bosque, Bogotá, Colombia.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Cabrera', 'Affiliation': 'Department of Anesthesia, Hospital Clínico de la Fuerza Aérea de Chile, Las Condes, Chile.'}, {'ForeName': 'Helder', 'Initials': 'H', 'LastName': 'Ribeiro', 'Affiliation': 'Department of Anesthesia and Critical Care, Centro Hospitalar Sao Joao, Porto, Portugal.'}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Celestino', 'Affiliation': 'Department of Anesthesia and Critical Care, Centro Hospitalar de Vila Nova de Gaia/Espinho, Vila Nova de Gaia, Portugal.'}, {'ForeName': 'Evrim', 'Initials': 'E', 'LastName': 'Kucur', 'Affiliation': 'Anesthesia and Critical Care, Medical Park Bahçelievler Hospital, Istanbul, Turkey.'}, {'ForeName': 'Oriol', 'Initials': 'O', 'LastName': 'Cervantes', 'Affiliation': 'Department of Anesthesia and Critical Care, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Morocho', 'Affiliation': 'Critical Care Department, Hospital de especialidades Eugenio Espejo, Quito, Ecuador.'}, {'ForeName': 'Dalia', 'Initials': 'D', 'LastName': 'Delphy', 'Affiliation': 'Department of Anesthesia, Alexandria University Hospital and Kafrelsheikh University Hospital, Alexandria, Egypt.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Ramos', 'Affiliation': 'Department of Anesthesia and Critical Care, Hospital Universitario Ntra Sra de Candelaria, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Villar', 'Affiliation': 'CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain; Research Unit, Hospital Universitario Dr. Negrín, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Belda', 'Affiliation': 'Department of Anesthesia and Critical Care, Hospital Clínico of Valencia, Valencia, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2019.01.056']
1040,30589984,"The effectiveness, safety and cost-effectiveness of cytisine versus varenicline for smoking cessation in an Australian population: a study protocol for a randomized controlled non-inferiority trial.","BACKGROUND AND AIMS


Smoking cessation medications are effective, but often underutilized because of costs and side effects. Cytisine is a plant-based smoking cessation medication with more than 50 years of use in central and eastern Europe. While cytisine has been found to be well-tolerated and more effective than nicotine replacement therapy, direct comparisons with varenicline have not been conducted. This study evaluates the effectiveness, safety and cost-effectiveness of cytisine compared with varenicline.
DESIGN


Two-arm, parallel group, randomized, non-inferiority trial, with allocation concealment and blinded outcome assessment.
SETTING


Australian population-based study.
PARTICIPANTS


Adult daily smokers (n = 1266) interested in quitting will be recruited through advertisements and Quitline telephone-based cessation support services.
INTERVENTION AND COMPARATOR


Eligible participants will be randomized (1 : 1 ratio) to receive either cytisine capsules (25-day supply) or varenicline tablets (12-week supply), prescribed in accordance with the manufacturer's recommended dosing regimen. The medication will be mailed to each participant's nominated residential address. All participants will also be offered standard Quitline behavioural support (up to six 10-12-minute sessions).
MEASUREMENTS


Assessments will be undertaken by telephone at baseline, 4 and 7 months post-randomization. Participants will also be contacted twice (2 and 4 weeks post-randomization) to ascertain adverse events, treatment adherence and smoking status. The primary outcome will be self-reported 6-month continuous abstinence from smoking, verified by carbon monoxide at 7-month follow-up. We will also evaluate the relative safety and cost-effectiveness of cytisine compared with varenicline. Secondary outcomes will include self-reported continuous and 7-day point prevalence abstinence and cigarette consumption at each follow-up interview.
COMMENTS


If cytisine is as effective as varenicline, its lower cost and natural plant-based composition may make it an acceptable and affordable smoking cessation medication that could save millions of lives world-wide.",2019,Cytisine is a plant-based smoking cessation medication with more than 50 years of use in central and eastern Europe.,"['Australian population-based study', 'Adult daily smokers (n\xa0', 'Australian population', '1266']","['varenicline', 'cytisine versus varenicline', 'cytisine', ""cytisine capsules (25-day supply) or varenicline tablets (12-week supply), prescribed in accordance with the manufacturer's recommended dosing regimen""]","['relative safety and cost-effectiveness', 'self-reported continuous and 7-day point prevalence abstinence and cigarette consumption at each follow-up interview', 'effectiveness, safety and cost-effectiveness', 'self-reported 6-month continuous abstinence from smoking, verified by carbon monoxide at 7-month follow-up']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0056913', 'cui_str': 'cytisine'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption (observable entity)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}]",1266.0,0.107318,Cytisine is a plant-based smoking cessation medication with more than 50 years of use in central and eastern Europe.,"[{'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Thomas', 'Affiliation': 'National Drug and Alcohol Research Centre (NDARC), University of New South Wales (UNSW), Sydney, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Farrell', 'Affiliation': 'National Drug and Alcohol Research Centre (NDARC), University of New South Wales (UNSW), Sydney, Australia.'}, {'ForeName': 'Hayden', 'Initials': 'H', 'LastName': 'McRobbie', 'Affiliation': 'National Drug and Alcohol Research Centre (NDARC), University of New South Wales (UNSW), Sydney, Australia.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Tutka', 'Affiliation': 'National Drug and Alcohol Research Centre (NDARC), University of New South Wales (UNSW), Sydney, Australia.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Petrie', 'Affiliation': 'Centre for Health Economics, Monash Business School, Monash University, Melbourne, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'West', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Siahpush', 'Affiliation': 'College of Public Health, University of Nebraska Medical Center, Omaha, United States.'}, {'ForeName': 'Coral', 'Initials': 'C', 'LastName': 'Gartner', 'Affiliation': 'Faculty of Medicine, School of Public Health, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Walker', 'Affiliation': 'National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Colin P', 'Initials': 'CP', 'LastName': 'Mendelsohn', 'Affiliation': 'School of Public Health and Community Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Hall', 'Affiliation': 'Faculty of Health and Behavioural Sciences, Centre for Youth Substance Abuse Research, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Paul', 'Affiliation': 'School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Zwar', 'Affiliation': 'School of Public Health and Community Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Stuart G', 'Initials': 'SG', 'LastName': 'Ferguson', 'Affiliation': 'School of Medicine, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'Veronica C', 'Initials': 'VC', 'LastName': 'Boland', 'Affiliation': 'National Drug and Alcohol Research Centre (NDARC), University of New South Wales (UNSW), Sydney, Australia.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Richmond', 'Affiliation': 'School of Public Health and Community Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Doran', 'Affiliation': 'Centre for Indigenous Health Equity Research, Central Queensland University, Brisbane, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Shakeshaft', 'Affiliation': 'National Drug and Alcohol Research Centre (NDARC), University of New South Wales (UNSW), Sydney, Australia.'}, {'ForeName': 'Richard P', 'Initials': 'RP', 'LastName': 'Mattick', 'Affiliation': 'National Drug and Alcohol Research Centre (NDARC), University of New South Wales (UNSW), Sydney, Australia.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Courtney', 'Affiliation': 'National Drug and Alcohol Research Centre (NDARC), University of New South Wales (UNSW), Sydney, Australia.'}]","Addiction (Abingdon, England)",['10.1111/add.14541']
1041,31812339,Antioxidant status following postprandial challenge of two different doses of tocopherols and tocotrienols.,"OBJECTIVE


Tocotrienols (T3s) have been hypothesized to have greater antioxidant capacity than tocopherols (Ts) due to differences in biokinetics that affect their absorption and function. The present trial compares the antioxidant effectiveness following postprandial challenge of two different doses of α-T or palm T3-rich fraction (TRF) treatments and evaluates their dose-response effects on antioxidant status.
METHODS


Ten healthy volunteers were given four different doses of vitamin E formulations (268 mg α-T, 537 mg α-T, 263 mg TRF or 526 mg TRF) in a cross-over postprandial trial. Blood was sampled at 0, 2, 4, 5, 6 and 8 hours after meal consumption and plasma antioxidant status including total glutathione, superoxide dismutase, malondialdehyde (MDA), ferric reducing antioxidant potential and trolox-equivalent antioxidant capacity, was analyzed.
RESULTS


Supplementation with the different doses of either α-T or TRF did not significantly improve overall antioxidant status. There was no significant difference in overall antioxidant status among treatments at the different doses compared. However, a significant dose-response effect was observed for plasma MDA throughout the 8-hour postprandial period. MDA was significantly lower after the 537 mg α-T treatment, compared to the 268 mg α-T treatment; it was also lower after the 526 mg TRF treatment compared to the 263 mg TRF treatment (P < 0.05).
CONCLUSION


T3 and α-T demonstrated similar antioxidant capacity, despite markedly lower levels of T3 in blood and lipoproteins, compared to α-T.",2020,"MDA was significantly lower after the 537 mg α-T treatment, compared to the 268 mg α-T treatment; it was also lower after the 526 mg TRF treatment compared to the 263 mg TRF treatment (P < 0.05).
",['Ten healthy volunteers'],"['α-T', 'α-T, 263\xa0mg TRF or 526\xa0mg TRF', 'vitamin E formulations', 'α-T or TRF', 'α-T or palm T3-rich fraction (TRF', 'tocopherols and tocotrienols']","['overall antioxidant status', 'antioxidant capacity', 'MDA', 'plasma MDA', 'plasma antioxidant status including total glutathione, superoxide dismutase, malondialdehyde (MDA), ferric reducing antioxidant potential and trolox-equivalent antioxidant capacity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0040162', 'cui_str': 'protirelin'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0230373', 'cui_str': 'Palm of hand (surface region)'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0949647', 'cui_str': 'Tocotrienols'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0069638', 'cui_str': 'orgotein'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0147003', 'cui_str': 'Trolox C'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}]",10.0,0.0683304,"MDA was significantly lower after the 537 mg α-T treatment, compared to the 268 mg α-T treatment; it was also lower after the 526 mg TRF treatment compared to the 263 mg TRF treatment (P < 0.05).
","[{'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Fairus', 'Affiliation': 'Malaysian Palm Oil Board, Persiaran Institusi, Bandar Baru Bangi, 43000 Kajang, Selangor, Malaysia. Electronic address: syfairus@mpob.gov.my.'}, {'ForeName': 'Hwee Ming', 'Initials': 'HM', 'LastName': 'Cheng', 'Affiliation': 'Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia.'}, {'ForeName': 'Kalyana', 'Initials': 'K', 'LastName': 'Sundram', 'Affiliation': 'Malaysian Palm Oil Council, Jalan Perbandaran, 47301 Kelana Jaya, Selangor, Malaysia.'}]",Journal of integrative medicine,['10.1016/j.joim.2019.11.005']
1042,30779960,"Does outpatient palliative care improve patient-centered outcomes in Parkinson's disease: Rationale, design, and implementation of a pragmatic comparative effectiveness trial.","Patients with Parkinson's disease and related disorders (PDRD) and their families have considerable unmet needs including non-motor symptom management, caregiver support, spiritual wellbeing, advance care planning, and end-of-life care. There is increasing interest in applying palliative care (PC) models to better meet these needs. While PC has been shown to improve care and quality of life (QOL) for people with cancer and heart failure, few studies have evaluated the role of PC for people with PDRD. Well-designed clinical trials are needed to optimize the PC approach for PDRD and to influence policy and implementation efforts. We initiated a randomized multicenter comparative effectiveness trial of team-based outpatient PC versus usual care for people with PDRD and their caregivers. The primary aims of this study are to determine the effects of PC on patient QOL and caregiver burden. Qualitative interviews will be utilized to gain additional insights into the impact of PC on participants, the outcomes that matter most to this population, and to find opportunities to refine future interventions and trials. As a novel application of PC, challenges involved in the design of this study include choosing appropriate inclusion criteria, standardizing the intervention, defining usual care, and choosing outcome measures suitable to our research questions. Challenges involved in implementation include participant recruitment, retention, and management of participant burden. We anticipate the results of this trial will have relevance for both clinical care and future clinical research trial design in evaluating models of PC for people with PDRD and other serious illnesses.",2019,We initiated a randomized multicenter comparative effectiveness trial of team-based outpatient PC versus usual care for people with PDRD and their caregivers.,"[""Parkinson's disease"", ""Patients with Parkinson's disease and related disorders (PDRD) and their families"", 'people with PDRD and their caregivers', 'people with cancer and heart failure']","['team-based outpatient PC versus usual care', 'PC']","['care and quality of life (QOL', 'patient QOL and caregiver burden']","[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C0034380'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}]",,0.106409,We initiated a randomized multicenter comparative effectiveness trial of team-based outpatient PC versus usual care for people with PDRD and their caregivers.,"[{'ForeName': 'Benzi M', 'Initials': 'BM', 'LastName': 'Kluger', 'Affiliation': 'Department of Neurology, University of Colorado School of Medicine, 12631 E 17th Ave, MS-B185, Aurora, CO 80045, USA. Electronic address: Benzi.Kluger@ucdenver.edu.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Katz', 'Affiliation': 'Movement Disorders and Neuromodulation Center, University of California, San Francisco 1635 Divisadero Street, Suite 520, San Francisco, CA 94118, USA. Electronic address: Maya.Katz@ucsf.edu.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Galifianakis', 'Affiliation': 'Movement Disorders and Neuromodulation Center, University of California, San Francisco 1635 Divisadero Street, Suite 520, San Francisco, CA 94118, USA. Electronic address: Nicholas.Galifianakis@ucsf.edu.'}, {'ForeName': 'Steven Z', 'Initials': 'SZ', 'LastName': 'Pantilat', 'Affiliation': 'Division of Palliative Medicine, Department of Medicine, University of California, San Francisco 533 Parnassus Ave., Suite U-109, Box 0131, San Francisco, CA 94143, USA. Electronic address: Steve.Pantilat@ucsf.edu.'}, {'ForeName': 'Jean S', 'Initials': 'JS', 'LastName': 'Kutner', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of Colorado School of Medicine, 12631 E 17th Ave, MS-B180, Aurora, CO, USA. Electronic address: Jean.Kutner@ucdenver.edu.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Sillau', 'Affiliation': 'Department of Neurology, University of Colorado School of Medicine, 12631 E 17th Ave, MS-B185, Aurora, CO 80045, USA. Electronic address: Stefan.Sillau@ucdenver.edu.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Gritz', 'Affiliation': 'Division of Healthcare Policy and Research, Department of Medicine, University of Colorado, 13199 East Montview Boulevard, MS-F480, Aurora, CO 80045, USA. Electronic address: Mark.Gritz@ucdenver.edu.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Jones', 'Affiliation': 'College of Nursing, University of Colorado, 13120 East 19th Avenue, MS-C288, Aurora, CO 80045, USA. Electronic address: Jacqueline.Jones@ucdenver.edu.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Fairclough', 'Affiliation': 'School of Public Health, Department of Biostatistics and Informatics, University of Colorado, 13199 East Montview Boulevard, MS-F443, Aurora, CO 80045, USA. Electronic address: Diane.Fairclough@ucdenver.edu.'}, {'ForeName': 'Malenna', 'Initials': 'M', 'LastName': 'Sumrall', 'Affiliation': 'Department of Neurology, University of Colorado School of Medicine, 12631 E 17th Ave, MS-B185, Aurora, CO 80045, USA.'}, {'ForeName': 'Kirk', 'Initials': 'K', 'LastName': 'Hall', 'Affiliation': 'Department of Neurology, University of Colorado School of Medicine, 12631 E 17th Ave, MS-B185, Aurora, CO 80045, USA.'}, {'ForeName': 'Janis', 'Initials': 'J', 'LastName': 'Miyasaki', 'Affiliation': 'Division of Neurology, University of Alberta, 11350-83 Avenue, 7-112 Clinical Sciences Building, Edmonton, AB T6G 2G3, Canada. Electronic address: miyasaki@ualberta.ca.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.02.005']
1043,30797041,PCI Alternative Using Sustained Exercise (PAUSE): Rationale and trial design.,"Cardiovascular disease (CVD) currently claims nearly one million lives yearly in the US, accounting for nearly 40% of all deaths. Coronary artery disease (CAD) accounts for the largest number of these deaths. While efforts aimed at treating CAD in recent decades have concentrated on surgical and catheter-based interventions, limited resources have been directed toward prevention and rehabilitation. CAD is commonly treated using percutaneous coronary intervention (PCI), and this treatment has increased exponentially since its adoption over three decades ago. Recent questions have been raised regarding the cost-effectiveness of PCI, the extent to which PCI is overused, and whether selected patients may benefit from optimal medical therapy in lieu of PCI. One alternative therapy that has been shown to improve outcomes in CAD is exercise therapy; exercise programs have been shown to have numerous physiological benefits, and a growing number of studies have demonstrated reductions in mortality. Given the high volume of PCI, its high cost, its lack of effect on survival and the potential for alternative treatments including exercise, the current study is termed ""PCI Alternative Using Sustained Exercise"" (PAUSE). The primary aim of PAUSE is to determine whether patients randomized to exercise and lifestyle intervention have greater improvement in coronary function and anatomy compared to those randomized to PCI. Coronary function and anatomy is determined using positron emission tomography combined with computed tomographic angiography (PET/CTA). Our objective is to demonstrate the utility of a non-invasive technology to document the efficacy of exercise as an alternative treatment strategy to PCI.",2019,Our objective is to demonstrate the utility of a non-invasive technology to document the efficacy of exercise as an alternative treatment strategy to PCI.,[],"['PCI Alternative Using Sustained Exercise (PAUSE', 'positron emission tomography combined with computed tomographic angiography (PET/CTA', 'percutaneous coronary intervention (PCI', 'exercise and lifestyle intervention', 'CAD']","['Coronary artery disease (CAD', 'coronary function and anatomy']",[],"[{'cui': 'C0582190', 'cui_str': 'Sustained exercise (observable entity)'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}]",,0.0518531,Our objective is to demonstrate the utility of a non-invasive technology to document the efficacy of exercise as an alternative treatment strategy to PCI.,"[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Myers', 'Affiliation': 'Veterans Affairs Palo Alto Health Care System, Division of Cardiovascular Medicine, Stanford University, United States of America. Electronic address: drj993@aol.com.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Fonda', 'Affiliation': 'Veterans Affairs Palo Alto Health Care System, Division of Cardiovascular Medicine, Stanford University, United States of America.'}, {'ForeName': 'Minal', 'Initials': 'M', 'LastName': 'Vasanawala', 'Affiliation': 'Veterans Affairs Palo Alto Health Care System, Division of Cardiovascular Medicine, Stanford University, United States of America.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Chung', 'Affiliation': 'Veterans Affairs Palo Alto Health Care System, Division of Cardiovascular Medicine, Stanford University, United States of America.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Segall', 'Affiliation': 'Veterans Affairs Palo Alto Health Care System, Division of Cardiovascular Medicine, Stanford University, United States of America.'}, {'ForeName': 'Khin', 'Initials': 'K', 'LastName': 'Chan', 'Affiliation': 'Veterans Affairs Palo Alto Health Care System, Division of Cardiovascular Medicine, Stanford University, United States of America.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Nguyen', 'Affiliation': 'Veterans Affairs Palo Alto Health Care System, Division of Cardiovascular Medicine, Stanford University, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.02.010']
1044,31944371,Adapted Dialectical Behavior Therapy for Adolescents with a High Risk of Suicide in a Community Clinic: A Pragmatic Randomized Controlled Trial.,"OBJECTIVE


This study is a pragmatic randomized controlled trial, which compares the effectiveness of an adapted form of Dialectical Behavior Therapy for Adolescents (DBT-A) and treatment as usual plus group sessions (TAU + GS) to reduce suicidal risk for adolescents in a community health mental clinic.
METHOD


Thirty-five adolescents from a community outpatient clinic, with repetitive NSSI alone or with SA over the last 12 months and with current high suicide risk as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS), were enrolled. Participants were randomly assigned to undergo either DBT-A (n = 18) or TAU + GT (n = 17) treatments over a 16-week period. Primary outcomes were the difference between NSSI and SA recorded during the first 4 weeks and the final 4 weeks of treatment. Secondary outcomes included changes in Children's Global Assessment Scale (C-GAS), Suicidal Ideation Questionnaire (SIQ-JR), and Beck Depression Inventory-II (BDI-II).
RESULTS


Dialectical Behavior Therapy for Adolescents was more effective than TAU + GS at reducing NSSI, use of antipsychotics, and improving C-GAS. No SAs were reported in the two groups at the end of the treatment. Both treatments were equally effective in decreasing SIQ-JR and BDI-II scores.
CONCLUSIONS


These findings support the feasibility and effectiveness of DBT-A for adolescents at high risk of suicide in community settings.",2020,"RESULTS


Dialectical Behavior Therapy for Adolescents was more effective than TAU + GS at reducing NSSI, use of antipsychotics, and improving C-GAS.","['adolescents in a community health mental clinic', 'Adolescents (DBT-A', 'adolescents at high risk of suicide in community settings', 'Thirty-five adolescents from a community outpatient clinic, with repetitive NSSI alone or with SA over the last 12\xa0months and with current high suicide risk as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS), were enrolled', 'Adolescents with a High Risk of Suicide in a Community Clinic']","['Dialectical Behavior Therapy', 'usual plus group sessions (TAU\xa0+\xa0GS', 'DBT-A (n\xa0=\xa018) or TAU\xa0+\xa0GT']","[""changes in Children's Global Assessment Scale (C-GAS), Suicidal Ideation Questionnaire (SIQ-JR), and Beck Depression Inventory-II (BDI-II"", 'NSSI and SA', 'SIQ-JR and BDI-II scores']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1271074', 'cui_str': 'High suicide risk'}, {'cui': 'C3888485', 'cui_str': 'Columbia suicide severity rating scale'}, {'cui': 'C0587907', 'cui_str': 'Community clinic (environment)'}]","[{'cui': 'C1321145', 'cui_str': 'Dialectical Behavior Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3472495', 'cui_str': ""Children's global assessment scale""}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",35.0,0.0947995,"RESULTS


Dialectical Behavior Therapy for Adolescents was more effective than TAU + GS at reducing NSSI, use of antipsychotics, and improving C-GAS.","[{'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Santamarina-Perez', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychology, 2017S GR88, Institute of Neuroscience, Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Iria', 'Initials': 'I', 'LastName': 'Mendez', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychology, 2017S GR88, Institute of Neuroscience, Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Manpreet K', 'Initials': 'MK', 'LastName': 'Singh', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Division of Child and Adolescent Psychiatry, Stanford University, Stanford, California.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Berk', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Division of Child and Adolescent Psychiatry, Stanford University, Stanford, California.'}, {'ForeName': 'Marisol', 'Initials': 'M', 'LastName': 'Picado', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychology, 2017S GR88, Institute of Neuroscience, Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Font', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychology, 2017S GR88, Institute of Neuroscience, Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Moreno', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychology, 2017S GR88, Institute of Neuroscience, Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Esteve', 'Initials': 'E', 'LastName': 'Martínez', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychology, 2017S GR88, Institute of Neuroscience, Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Morer', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychology, 2017S GR88, Institute of Neuroscience, Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Borràs', 'Affiliation': ""Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Cosi', 'Affiliation': 'Department of Psychology, Universitat Rovira i Virgili, Reus, Spain.'}, {'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'Romero', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychology, 2017S GR88, Institute of Neuroscience, Hospital Clínic, Barcelona, Spain.'}]",Suicide & life-threatening behavior,['10.1111/sltb.12612']
1045,31929374,Intravenous Ibuprofen Reduces Opioid Consumption During the Initial 48 Hours After Injury in Orthopedic Trauma Patients.,"OBJECTIVES


To evaluate the efficacy of intravenous (IV) ibuprofen (Caldolor) administration in the management of acute pain in orthopedic trauma patients and to minimize opioid use.
DESIGN


Randomized controlled trial, double-blind, parallel, placebo-controlled.
SETTING


Level 1 Trauma Center.
PATIENTS


A total of 99 consecutive orthopedic trauma patients with fractures of the ribs, face, extremities, and/or pelvis were randomized to receive either 800 mg IV ibuprofen (53 patients) or placebo (44 patients) administered every 6 hours for a total of 8 doses within 48 hours of admission and the same PRN medications along with 20-mg IV/PO Pepcid twice a day. To establish pain reduction efficacy, the analysis was consequently performed in the modified intent-to-treat group that included 74 randomized subjects with a baseline pain score greater than 2. The primary outcomes were reduction in opioid consumption and decrease in pain intensity (PI).
INTERVENTION


Administration of study medications.
OUTCOME MEASUREMENTS


PI measured by Numerical Rating Scale, opioid consumption adjusted to morphine equivalent dose, and time to first narcotic administration.
RESULTS


The 2 groups had comparable baseline characteristics: age, sex distribution, mechanism of injury, type of injury, injury severity score, and PI. IV ibuprofen statistically significantly reduced opioid consumption compared with placebo during the initial 48-hour period (P = 0.017). PI calculated as PI differences was statistically different only at 8-hour interval after Caldolor administration. Time to first narcotic medication was significantly longer in the Caldolor group (hazard ratio: 1.640; 95% confidence interval, 1.009-2.665; P = 0.046).
CONCLUSIONS


IV ibuprofen provided adequate analgesia, prolonged time to first narcotic administration, and was opioid-sparing for the treatment of pain in orthopedic trauma patients, which makes Caldolor a recommended candidate for managing acute pain in the diverse orthopaedic trauma population.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"CONCLUSIONS


IV ibuprofen provided adequate analgesia, prolonged time to first narcotic administration and was opioid-sparing for the treatment of pain in orthopedic trauma patients, which makes Caldolor® a recommended candidate for managing acute pain in the diverse orthopaedic trauma population.
","['74 randomized subjects with a baseline pain score greater than 2', 'Orthopedic Trauma Patients', 'orthopedic trauma patients', '99 consecutive orthopedic trauma patients with fractures of the ribs, face, extremities and/or pelvis']","['ibuprofen', 'Intravenous Ibuprofen', 'placebo', 'IV ibuprofen', 'ibuprofen (Caldolor®', '800 mg intravenous (IV) ibuprofen']","['Pain intensity measured by Numerical Rating Scale, opioid consumption adjusted to morphine equivalent dose and time to first narcotic administration', 'Opioid Consumption', 'Pain intensity calculated as pain intensity differences', 'Time to first narcotic medication', 'reduction in opioid consumption and decrease in pain intensity', 'opioid consumption']","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0035561', 'cui_str': 'Ribs'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2702462', 'cui_str': 'Caldolor'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}]",74.0,0.533767,"CONCLUSIONS


IV ibuprofen provided adequate analgesia, prolonged time to first narcotic administration and was opioid-sparing for the treatment of pain in orthopedic trauma patients, which makes Caldolor® a recommended candidate for managing acute pain in the diverse orthopaedic trauma population.
","[{'ForeName': 'Russell D', 'Initials': 'RD', 'LastName': 'Weisz', 'Affiliation': 'Delray Medical Center, Delray Beach, FL.'}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Fokin', 'Affiliation': 'Delray Medical Center, Delray Beach, FL.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Lerner', 'Affiliation': 'Delray Medical Center, Delray Beach, FL.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Flynt', 'Affiliation': 'PharPoint Research, Durham, NC.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Macias-Perez', 'Affiliation': 'Cumberland Pharmaceuticals, Nashville, TN.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Pavliv', 'Affiliation': 'Cumberland Pharmaceuticals, Nashville, TN.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Crawford', 'Affiliation': 'Delray Medical Center, Delray Beach, FL.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Puente', 'Affiliation': 'Delray Medical Center, Delray Beach, FL.'}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001733']
1046,31928313,In vivo carbon dioxide clearance of a low-flow extracorporeal carbon dioxide removal circuit in patients with acute exacerbations of chronic obstructive pulmonary disease.,"BACKGROUND


Veno-venous extracorporeal carbon dioxide removal allows clearance of CO 2  from the blood and is becoming popular to enhance protective mechanical ventilation and assist in the management of acute exacerbations of chronic obstructive pulmonary disease, including the prevention of intubation. The main factor determining CO 2  transfer across a membrane lung for any given blood flow rate and venous CO 2  content is the sweep gas flow rate. The in vivo characteristics of CO 2  clearance using ultra-low blood flow devices in patients with acute exacerbations of chronic obstructive pulmonary disease has not been previously described.
METHODS


Patients commenced on extracorporeal carbon dioxide removal for acute exacerbations of chronic obstructive pulmonary disease recruited to a randomized controlled trial of non-invasive ventilation versus extracorporeal carbon dioxide removal had pre- and post-membrane circuit gases measured after each increment of sweep gas flow to allow calculation of the transmembrane CO 2  clearance. This was compared with the clearance reported by the device and also corrected to inlet PCO 2  to allow characterization of the CO 2  clearance of the device at different sweep gas flow rates.
RESULTS


CO 2  clearance was calculated using both the transmembrane CO 2  whole-blood content difference and CO 2  clearance reported by the device. The two methods demonstrated a linear relationship and agreement with a bias of 14 mL/minute (SD = ±10) and an R 2  of 0.92. The membrane CO 2  clearance was non-linear with nearly two thirds of total clearance achieved with sweep gas flow below 2 L/minute (VCO 2  of 40 ± 16.7 mL/minute) and a plateau above 5 L/minute sweep gas flow (VCO 2  64 ± 1 2.4 mL/minute).
CONCLUSION


The extracorporeal carbon dioxide removal device used in the study provides efficient clearance of CO 2  at low sweep flow rates which then plateaus. This has implications for how the device may be used in clinical practice, particularly during the weaning phase where the final discontinuation of the device may take longer than anticipated. (ClinicalTrials.gov: NCT02086084, registered 13 March 2014, https://clinicaltrials.gov/ct2/show/NCT02086084 ).",2020,The two methods demonstrated a linear relationship and agreement with a bias of 14 mL/minute (SD = ±10) and an R 2  of 0.92.,"['Patients commenced on', 'for acute exacerbations of chronic obstructive pulmonary disease', 'patients with acute exacerbations of chronic obstructive pulmonary disease']","['vivo carbon dioxide clearance of a low-flow extracorporeal carbon dioxide removal circuit', 'extracorporeal carbon dioxide removal device', 'non-invasive ventilation versus extracorporeal carbon dioxide removal had pre- and post-membrane circuit gases', 'ultra-low blood flow devices', 'extracorporeal carbon dioxide removal']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease (disorder)'}]","[{'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0398339', 'cui_str': 'Extracorporeal carbon dioxide removal (procedure)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}]",[],,0.210584,The two methods demonstrated a linear relationship and agreement with a bias of 14 mL/minute (SD = ±10) and an R 2  of 0.92.,"[{'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Barrett', 'Affiliation': ""Centre for Human & Applied Physiological Sciences (CHAPS) and School of Basic & Medical Biosciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.""}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Hart', 'Affiliation': ""Centre for Human & Applied Physiological Sciences (CHAPS) and School of Basic & Medical Biosciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.""}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Camporota', 'Affiliation': ""Centre for Human & Applied Physiological Sciences (CHAPS) and School of Basic & Medical Biosciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.""}]",Perfusion,['10.1177/0267659119896531']
1047,31923632,Evaluation of the effect of photodynamic therapy on chemotherapy induced oral mucositis.,"BACKGROUND


In this study the effect of photodynamic therapy on chemotherapy induced mucositis was evaluated.
METHODS


This randomized single blind clinical pilot evaluation evaluated the effect of PDT with methylene blue on 15 patients with chemotherapy induced bilateral oral mucositis. They were divided into 2 groups (control side and intervention side). Methylene blue was applied on the lesions of both sides, after 10 min the lesion of intervention side was irradiated by a 660 nm diode laser InGaAlP(Azor-2 K) for 10 min (power: 25 mW, dose:19.23 J/CM2, probe diameter: 0.78 cm2) for three sessions (day1,3,5) and followed on day 12. In control side only sham laser was used. Data were analyzed by Wilcoxon and Mann-Whitney test using SPSS version 22.
RESULTS


Comparing the WCCNR and NCI difference in different sessions between intervention and control group, represented significant improvement in oral mucositis in photodynamic therapy group for sessions 1-0, 2-0, 3-0 (P.value<0.05).
CONCLUSION


Photodynamic therapy can improve chemotherapy induced oral mucositis.",2020,"Comparing the WCCNR and NCI difference in different sessions between intervention and control group, represented significant improvement in oral mucositis in photodynamic therapy group for sessions 1-0, 2-0, 3-0 (P.value<0.05).
",['15 patients with chemotherapy induced bilateral oral mucositis'],"['Methylene blue', 'PDT with methylene blue', 'Photodynamic therapy', 'photodynamic therapy']",['oral mucositis'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C1568868', 'cui_str': 'Oral Mucositis'}]","[{'cui': 'C0025746', 'cui_str': 'methylthioninium chloride'}, {'cui': 'C0044588', 'cui_str': 'PDT'}, {'cui': 'C0031740', 'cui_str': 'Photodynamic Therapy'}]","[{'cui': 'C1568868', 'cui_str': 'Oral Mucositis'}]",,0.0139962,"Comparing the WCCNR and NCI difference in different sessions between intervention and control group, represented significant improvement in oral mucositis in photodynamic therapy group for sessions 1-0, 2-0, 3-0 (P.value<0.05).
","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Lavaee', 'Affiliation': 'Oral and Dental Disease Research Center, Assistant Professor of Oral and Maxillofacial Disease Department, School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: lavaeef@sums.ac.ir.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Amanati', 'Affiliation': 'Professor Alborzi Clinical Microbiology Research Center, Shiraz, Iran. Electronic address: Ali_amanati_1356@yahoo.com.'}, {'ForeName': 'Mani', 'Initials': 'M', 'LastName': 'Ramzi', 'Affiliation': 'Hematology Research Center, Department of Hematology, Oncology, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: ramzim@sums.ac.ir.'}, {'ForeName': 'Setareh', 'Initials': 'S', 'LastName': 'Naseri', 'Affiliation': 'School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: naseri_setareh@yahoo.com.'}, {'ForeName': 'Hajar', 'Initials': 'H', 'LastName': 'Shakiba Sefat', 'Affiliation': 'School of Dentistry, Arak University of Medical Sciences, Arak, Iran. Electronic address: shakibasefat@gmail.com.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101653']
1048,31818694,Effects of the use of bioceramic wraps in patients with lower limb venous ulcers: A randomized double-blind placebo-controlled trial.,"BACKGROUND


Venous ulcer represents the most advanced stage of chronic venous insufficiency. It is an important public health problem and has a significant impact on patients' quality of life due to chronic pain, inability to work, need for hospitalization and frequent outpatient follow-up.
OBJECTIVE


We investigated the treatment benefits of far-infrared ceramic (cFIR), in a 90-day study of lower limb venous ulcers and looked at ulcer healing scores, quality of life, serum bio-markers of oxidative stress and antioxidant defense enzymes.
DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS


This is a randomized double-blind placebo-controlled study conducted in the Vascular Surgery Service of a hospital located in the northwest region of the State of Rio Grande do Sul, Brazil. We included patients with lower limb venous ulcers who were randomized to use either a bioceramics wrap or a placebo wrap for 90 days.
MAIN OUTCOME MEASURES


The following evaluations were conducted at baseline and after 15, 30, 60 and 90 days: ulcer healing score, quality of life, and serum markers of oxidative stress and antioxidant enzyme activity.
RESULTS


Patients (n = 24) with lower limb venous ulcers were randomized into two treatment groups. cFIR decreased the ulcer size on day 30 (P = 0.042) and 90 (P = 0.034) and the total ulcer healing scale scores on day 30 (P = 0.049) and 90 (P = 0.02) of the treatment, when compared to baseline. Additionally, cFIR improved tissue type (epithelial tissue) on day 60 (P = 0.022) when compared to baseline evaluation.
CONCLUSION


cFIR clinically improved ulcer healing in patients with lower limb venous ulcers.
TRIAL REGISTRATION


RBR-8c7xzn on ReBEC.",2020,"cFIR decreased the ulcer size on day 30 (P = 0.042) and 90 (P = 0.034) and the total ulcer healing scale scores on day 30 (P = 0.049) and 90 (P = 0.02) of the treatment, when compared to baseline.","['Vascular Surgery Service of a hospital located in the northwest region of the State of Rio Grande do Sul, Brazil', 'patients with lower limb venous ulcers', 'Patients (n\xa0', '24) with lower limb venous ulcers']","['placebo', 'bioceramics wrap or a placebo', 'infrared ceramic (cFIR', 'bioceramic wraps']","['ulcer healing score, quality of life, and serum markers of oxidative stress and antioxidant enzyme activity', 'ulcer healing', 'cFIR improved tissue type (epithelial tissue', 'ulcer healing scores, quality of life, serum bio-markers of oxidative stress and antioxidant defense enzymes', 'total ulcer healing scale scores', 'ulcer size']","[{'cui': 'C0587697', 'cui_str': 'Vascular surgery service (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0445581', 'cui_str': 'Rio (qualifier value)'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0042344', 'cui_str': 'Venous Stasis Ulcers'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445414', 'cui_str': 'Wrapping (procedure)'}, {'cui': 'C0007742', 'cui_str': 'Ceramics'}]","[{'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0162491', 'cui_str': 'Serum Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0243102', 'cui_str': 'enzyme activity'}, {'cui': 'C0019633', 'cui_str': 'Crossmatching, Tissue'}, {'cui': 'C0014609', 'cui_str': 'Epithelial Tissue'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C3541394', 'cui_str': 'Enzymes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}]",,0.115828,"cFIR decreased the ulcer size on day 30 (P = 0.042) and 90 (P = 0.034) and the total ulcer healing scale scores on day 30 (P = 0.049) and 90 (P = 0.02) of the treatment, when compared to baseline.","[{'ForeName': 'Gerli E G', 'Initials': 'GEG', 'LastName': 'Herr', 'Affiliation': 'Integral Health Care, Regional University of the Northwest of the State of Rio Grande do Sul (UNIJUÍ) and University of Cruz Alta (UNICRUZ), Ijuí 98700-000, RS, Brazil.'}, {'ForeName': 'Fábio Goulart', 'Initials': 'FG', 'LastName': 'da Silva', 'Affiliation': 'Integral Health Care, Regional University of the Northwest of the State of Rio Grande do Sul (UNIJUÍ) and University of Cruz Alta (UNICRUZ), Ijuí 98700-000, RS, Brazil.'}, {'ForeName': 'Francisco José', 'Initials': 'FJ', 'LastName': 'Cidral-Filho', 'Affiliation': 'Experimental Neuroscience Laboratory (LaNEx), University of Southern Santa Catarina, Palhoça 88137-270, SC, Brazil.'}, {'ForeName': 'Fabricia', 'Initials': 'F', 'LastName': 'Petronilho', 'Affiliation': 'Laboratory of Neurobiology of Inflammatory and Metabolic Processes, University of Southern Santa Catarina, Tubarão 88704-900, SC, Brazil.'}, {'ForeName': 'Lucinéia Gainski', 'Initials': 'LG', 'LastName': 'Danielski', 'Affiliation': 'Laboratory of Neurobiology of Inflammatory and Metabolic Processes, University of Southern Santa Catarina, Tubarão 88704-900, SC, Brazil.'}, {'ForeName': 'Mariana Pereira', 'Initials': 'MP', 'LastName': 'de Souza Goldim', 'Affiliation': 'Laboratory of Neurobiology of Inflammatory and Metabolic Processes, University of Southern Santa Catarina, Tubarão 88704-900, SC, Brazil.'}, {'ForeName': 'Afonso Shiguemi Inoue', 'Initials': 'ASI', 'LastName': 'Salgado', 'Affiliation': 'Experimental Neuroscience Laboratory (LaNEx), University of Southern Santa Catarina, Palhoça 88137-270, SC, Brazil; Integrative Physical Therapy Residency, Philadelphia University Center, Londrina 86020-000, PR, Brazil.'}, {'ForeName': 'Franciane', 'Initials': 'F', 'LastName': 'Bobinski', 'Affiliation': 'Experimental Neuroscience Laboratory (LaNEx), University of Southern Santa Catarina, Palhoça 88137-270, SC, Brazil.'}, {'ForeName': 'Daniel Fernandes', 'Initials': 'DF', 'LastName': 'Martins', 'Affiliation': 'Experimental Neuroscience Laboratory (LaNEx), University of Southern Santa Catarina, Palhoça 88137-270, SC, Brazil. Electronic address: daniel.martins4@unisul.br.'}, {'ForeName': 'Eliane R', 'Initials': 'ER', 'LastName': 'Winkelmann', 'Affiliation': 'Integral Health Care, Regional University of the Northwest of the State of Rio Grande do Sul (UNIJUÍ) and University of Cruz Alta (UNICRUZ), Ijuí 98700-000, RS, Brazil; Laboratory of Exercise Physiopathology, Department of Life Sciences (DCVida), Regional University of the Northwest of the State of Rio Grande do Sul (UNIJUÍ), Ijuí 98700-000, RS, Brazil.'}]",Journal of integrative medicine,['10.1016/j.joim.2019.11.006']
1049,31504694,High-Dose Neonatal Vitamin A Supplementation Transiently Decreases Thymic Function in Early Infancy.,"BACKGROUND


Vitamin A deficiency (VAD) impairs T-cell-mediated immunity. In regions where VAD is prevalent, vitamin A supplementation (VAS) reduces child mortality, perhaps by improving immune function.
OBJECTIVE


Our objective was to determine if neonatal VAS would improve thymic function in Bangladeshi infants, and to determine if such effects differed by sex or nutritional status (i.e., birth weight above/below the median).
METHODS


Three hundred and six infants were randomly assigned to 50,000 IU vitamin A (VA) or placebo (PL) within 48 h of birth. Primary outcomes were measured at multiple ages and included 1) thymic index (TI) at 1, 6, 10, and 15 wk; 2) T-cell receptor excision circles (TREC), an index of thymic output of naïve T cells; and 3) total/naïve T cells in peripheral blood at 6 wk, 15 wk, and 2 y. A mixed linear model for repeated measures was used to assess group differences at each age and identify interactions with sex and birth weight.
RESULTS


VAS did not significantly (P = 0.21) affect TI overall (i.e., at all ages) but decreased TI by 7.8% (P = 0.029) at 6 wk: adjusted TI means for the PL and VA groups at 1, 6, 10, and 15 wk were 4.09 compared with 3.80 cm2, 7.78 compared with 7.18 cm2, 8.11 compared with 7.84 cm2, and 7.91 compared with 7.97 cm2, respectively. VAS did not significantly (P = 0.25) affect TREC overall but decreased TREC by 19% (P = 0.029) at 15 wk: adjusted TREC means for the PL and VA groups at 6 wk, 15 wk, and 2 y were 13.6 compared with 16.1 copies/pg DNA, 19.4 compared with 15.7 copies/pg DNA, and 11.8 compared with 10.0 copies/pg DNA, respectively. VAS did not significantly affect overall total (P = 0.10) or naïve (P = 0.092) T cells: adjusted naïve T-cell means for the PL and VA groups at 6 wk, 15 wk, and 2 y were 3259 compared with 3109 cells/µL, 3771 compared with 3487 cells/µL, and 1976 compared with 1898 cells/µL, respectively.
CONCLUSION


In contrast to our hypothesis, VAS decreased thymic function early in infancy but health effects are presumably negligible owing to the transience and small magnitude of this effect. This trial was registered at clinicaltrials.gov as NCT01583972 and NCT02027610.",2020,VAS did not significantly affect overall total (P = 0.10) or naïve (P = 0.092),"['Three hundred and six infants', 'Bangladeshi infants']","['High-Dose Neonatal Vitamin A Supplementation', '50,000 IU vitamin A (VA) or placebo (PL', 'VAS', 'vitamin A supplementation (VAS']","['TREC overall but decreased TREC', 'VAS', 'TI overall', 'multiple ages and included 1) thymic index (TI) at 1, 6, 10, and 15 wk; 2) T-cell receptor excision circles (TREC), an index of thymic output of naïve T cells; and 3) total/naïve T cells in peripheral blood']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0422784', 'cui_str': 'Bangladeshi'}]","[{'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C4524019', 'cui_str': 'Vitamin A supplementation'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1515131', 'cui_str': 'T-cell receptor excision circle'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}]",306.0,0.421347,VAS did not significantly affect overall total (P = 0.10) or naïve (P = 0.092),"[{'ForeName': 'Shaikh M', 'Initials': 'SM', 'LastName': 'Ahmad', 'Affiliation': 'Immunobiology, Nutrition, and Toxicology Laboratory, Infectious Diseases Division, icddr,b, Mohakhali, Dhaka, Bangladesh.'}, {'ForeName': 'Rubhana', 'Initials': 'R', 'LastName': 'Raqib', 'Affiliation': 'Immunobiology, Nutrition, and Toxicology Laboratory, Infectious Diseases Division, icddr,b, Mohakhali, Dhaka, Bangladesh.'}, {'ForeName': 'M Nazmul', 'Initials': 'MN', 'LastName': 'Huda', 'Affiliation': 'Immunobiology, Nutrition, and Toxicology Laboratory, Infectious Diseases Division, icddr,b, Mohakhali, Dhaka, Bangladesh.'}, {'ForeName': 'Md J', 'Initials': 'MJ', 'LastName': 'Alam', 'Affiliation': 'Immunobiology, Nutrition, and Toxicology Laboratory, Infectious Diseases Division, icddr,b, Mohakhali, Dhaka, Bangladesh.'}, {'ForeName': 'Md', 'Initials': 'M', 'LastName': 'Monirujjaman', 'Affiliation': 'Immunobiology, Nutrition, and Toxicology Laboratory, Infectious Diseases Division, icddr,b, Mohakhali, Dhaka, Bangladesh.'}, {'ForeName': 'Taslima', 'Initials': 'T', 'LastName': 'Akhter', 'Affiliation': 'Immunobiology, Nutrition, and Toxicology Laboratory, Infectious Diseases Division, icddr,b, Mohakhali, Dhaka, Bangladesh.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Wagatsuma', 'Affiliation': 'Department of Clinical Trials and Clinical Epidemiology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Firdausi', 'Initials': 'F', 'LastName': 'Qadri', 'Affiliation': 'Immunobiology, Nutrition, and Toxicology Laboratory, Infectious Diseases Division, icddr,b, Mohakhali, Dhaka, Bangladesh.'}, {'ForeName': 'Melissa S', 'Initials': 'MS', 'LastName': 'Zerofsky', 'Affiliation': 'USDA Western Human Nutrition Research Center at University of California, Davis, CA, USA.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Stephensen', 'Affiliation': 'USDA Western Human Nutrition Research Center at University of California, Davis, CA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxz193']
1050,31504714,Obesity and Insulin Resistance Are Inversely Associated with Serum and Adipose Tissue Carotenoid Concentrations in Adults.,"BACKGROUND


Low tissue concentrations of carotenoids have been suggested to contribute to insulin resistance in obesity.
OBJECTIVES


The objectives of the study were to 1) evaluate the relations of adipose tissue and serum carotenoids with body fat, abdominal fat distribution, muscle, adipose tissue and liver insulin resistance, and dietary intake; 2) evaluate the relations and distributions of carotenoids detected in adipose tissue and serum; and 3) compare serum carotenoids and retinol concentrations in subjects with and without obesity.
METHODS


Post hoc analysis of serum and adipose tissue carotenoids in individuals [n = 80; 31 men, 49 women; age (mean ± SEM): 51.4 ± 1.1 y] who participated in 2 separate studies conducted at the Clinical Research Facility at the Garvan Institute of Medical Research (Sydney) between 2008 and 2013. Retinol, α-carotene, β-carotene, ζ-carotene, lutein, lycopene, phytoene, and phytofluene were measured using HPLC. Body composition was measured by dual-energy X-ray absorptiometry. Insulin resistance was measured by 2-step hyperinsulinemic-euglycemic clamps with deuterated glucose (n = 64), and subcutaneous and visceral abdominal volume and liver and pancreatic fat by MRI (n = 60). Periumbilical subcutaneous fat biopsy was performed and carotenoids and retinol measured in the tissue (n = 16).
RESULTS


We found that ζ-carotene, phytoene, and phytofluene were stored in considerable amounts in adipose tissue (25% of adipose tissue carotenoids). Carotenoid concentrations in adipose tissue and serum correlated significantly, but they followed different distributions: ζ-carotene was 3-fold higher in adipose tissue compared with serum, while lutein and lycopene made up 20% and 21% of serum carotenoids compared with 2% and 12% of adipose tissue carotenoids, respectively. Liver (P ≤ 0.028) and adipose tissue (P = 0.023), but not muscle (P ≥ 0.16), insulin resistance correlated inversely with many of the serum carotenoids.
CONCLUSIONS


Multiple serum and adipose tissue carotenoids are associated with favorable metabolic traits, including insulin sensitivity in liver and adipose tissue in humans.",2020,"Carotenoid concentrations in adipose tissue and serum correlated significantly, but they followed different distributions: ζ-carotene was 3-fold higher in adipose tissue compared with serum, while lutein and lycopene made up 20% and 21% of serum carotenoids compared with 2% and 12% of adipose tissue carotenoids, respectively.","['Adults', 'subjects with and without obesity', 'individuals [n\xa0=\xa080; 31 men, 49 women; age (mean ±\xa0SEM): 51.4\xa0±\xa01.1 y] who participated in 2 separate studies conducted at the Clinical Research Facility at the Garvan Institute of Medical Research (Sydney) between 2008 and 2013']",['hyperinsulinemic-euglycemic clamps with deuterated glucose'],"['adipose tissue and serum carotenoids with body fat, abdominal fat distribution, muscle, adipose tissue and liver insulin resistance, and dietary intake', 'Obesity and Insulin Resistance', 'adipose tissue', 'Body composition', 'Retinol, α-carotene, β-carotene, ζ-carotene, lutein, lycopene, phytoene, and phytofluene', 'Insulin resistance', 'Carotenoid concentrations in adipose tissue and serum', 'serum carotenoids and retinol concentrations', 'insulin resistance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0079816', 'cui_str': 'Medical Research'}]","[{'cui': 'C0079318', 'cui_str': 'Glucose Clamp'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]","[{'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0007271', 'cui_str': 'Carotenes and Carotenoids'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1563742', 'cui_str': 'Abdominal Fat'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0087161', 'cui_str': 'All-Trans-Retinol'}, {'cui': 'C0373568', 'cui_str': 'Carotene measurement (procedure)'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0065331', 'cui_str': 'lycopene'}, {'cui': 'C0959956', 'cui_str': 'phytoene, (15-cis)-isomer'}, {'cui': 'C0071013', 'cui_str': 'phytofluene'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",49.0,0.0187071,"Carotenoid concentrations in adipose tissue and serum correlated significantly, but they followed different distributions: ζ-carotene was 3-fold higher in adipose tissue compared with serum, while lutein and lycopene made up 20% and 21% of serum carotenoids compared with 2% and 12% of adipose tissue carotenoids, respectively.","[{'ForeName': 'Ayelet', 'Initials': 'A', 'LastName': 'Harari', 'Affiliation': 'The Bert W Strassburger Lipid Center, Sheba Medical Center, Tel-Hashomer, Israel.'}, {'ForeName': 'Adelle C F', 'Initials': 'ACF', 'LastName': 'Coster', 'Affiliation': 'School of Mathematics and Statistics, UNSW, Sydney, Australia.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Jenkins', 'Affiliation': 'Diabetes and Metabolism Division, Garvan Institute of Medical Research, Sydney, Australia.'}, {'ForeName': 'Aimin', 'Initials': 'A', 'LastName': 'Xu', 'Affiliation': 'State Key Laboratory of Pharmaceutical Biotechnology, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Jerry R', 'Initials': 'JR', 'LastName': 'Greenfield', 'Affiliation': 'Diabetes and Metabolism Division, Garvan Institute of Medical Research, Sydney, Australia.'}, {'ForeName': 'Dror', 'Initials': 'D', 'LastName': 'Harats', 'Affiliation': 'The Bert W Strassburger Lipid Center, Sheba Medical Center, Tel-Hashomer, Israel.'}, {'ForeName': 'Aviv', 'Initials': 'A', 'LastName': 'Shaish', 'Affiliation': 'The Bert W Strassburger Lipid Center, Sheba Medical Center, Tel-Hashomer, Israel.'}, {'ForeName': 'Dorit', 'Initials': 'D', 'LastName': 'Samocha-Bonet', 'Affiliation': 'Diabetes and Metabolism Division, Garvan Institute of Medical Research, Sydney, Australia.'}]",The Journal of nutrition,['10.1093/jn/nxz184']
1051,31931250,Effect of Dexmedetomidine with Different Anesthetic Dosage on Neurocognitive Function in Elderly Patients After Operation Based on Neural Network Model.,"This paper uses a neural network model to study the protective effect of dexmedetomidine on the anesthesia recovery period and neurocognitive function in elderly patients undergoing radical resection of colorectal cancer. Eighty-eight patients with colorectal cancer who underwent radical surgery in our hospital from January 2015 to June 2017 were randomly divided into groups: study (43 cases) and control (45 cases). The study group was treated with dexmedetomidine for anesthesia. Patients in the study group were given a slow pumping dose of 1 μg/kg to prepare dexmedetomidine at a dose of 1 μg/kg. The pumping time was >10 minutes, and the dose was 0.3 μg after completion. The loading dose of 0.3 (kg·h) was maintained intraoperatively; the control group was given the same amount of saline infusion by the same infusion method. The study found that the probability of cognitive dysfunction in the study group was significantly lower than that in the control group, and the degree of cognitive dysfunction in the study group was significantly lower than that in the control group (P < 0.05). Therefore in the operation of elderly patients with colorectal cancer radical surgery, dexmedetomidine is used for anesthesia to protect postoperative cognitive function and reduce the incidence of cognitive dysfunction. Extensive promotion and application in the clinic.",2020,"The study found that the probability of cognitive dysfunction in the study group was significantly lower than that in the control group, and the degree of cognitive dysfunction in the study group was significantly lower than that in the control group (P<0.05).","['elderly patients after operation based on neural network model', 'Eighty-eight patients with colorectal cancer who underwent radical surgery in our hospital from January 2015 to June 2017', 'elderly patients with colorectal cancer radical surgery', 'elderly patients undergoing radical resection of colorectal cancer']","['dexmedetomidine', 'slow pumping dose of 1 μg/kg to prepare dexmedetomidine']","['neurocognitive function', 'degree of cognitive dysfunction', 'probability of cognitive dysfunction', 'pumping time']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0870951', 'cui_str': 'Connectionist Models'}, {'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",2017.0,0.0161078,"The study found that the probability of cognitive dysfunction in the study group was significantly lower than that in the control group, and the degree of cognitive dysfunction in the study group was significantly lower than that in the control group (P<0.05).","[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, The Fifth Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China. Electronic address: chenhongyishengys@163.com.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, The Fifth Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China.'}]",World neurosurgery,['10.1016/j.wneu.2020.01.012']
1052,31915000,Implementing the theory-based advance care planning ACP+ programme for nursing homes: study protocol for a cluster randomised controlled trial and process evaluation.,"BACKGROUND


Research has highlighted the need for improving the implementation of advance care planning (ACP) in nursing homes. We developed a theory-based multicomponent ACP intervention (the ACP+ programme) aimed at supporting nursing home staff with the implementation of ACP into routine nursing home care. We describe here the protocol of a cluster randomised controlled trial (RCT) that aims to evaluate the effects of ACP+ on nursing home staff and volunteer level outcomes and its underlying processes of change.
METHODS


We will conduct a cluster RCT in Flanders, Belgium. Fourteen eligible nursing homes will be pair-matched and one from each pair will be randomised to either continue care and education as usual or to receive the ACP+ programme (a multicomponent programme which is delivered stepwise over an eight-month period with the help of an external trainer). Primary outcomes are: nursing home care staff's knowledge of, and self-efficacy regarding ACP. Secondary outcomes are: 1) nursing home care staff's attitudes towards ACP and ACP practices; 2) support staff's and volunteer's ACP practices and 3) support staff's and volunteers' self-efficacy. Measurements will be performed at baseline and eight months post-measurement, using structured self-reported questionnaires. A process evaluation will accompany the outcome evaluation in the intervention group, with measurements throughout and post-intervention to assess implementation, mechanisms of impact and context and will be carried out using a mixed-methods design.
DISCUSSION


There is little high-quality evidence regarding the effectiveness and underlying processes of change of ACP in nursing homes. This combined outcome and process evaluation of the ACP+ programme aims to contribute to building the necessary evidence to improve ACP and its uptake for nursing home residents and their family.
TRIAL REGISTRATION


The study is registered at ClinicalTrials.gov (no. NCT03521206). Registration date: May 10, 2018. Inclusion of nursing homes started March, 2018. Hence, the trial was retrospectively registered but before end of data collection and analyses.",2020,We developed a theory-based multicomponent ACP intervention (the ACP+ programme) aimed at supporting nursing home staff with the implementation of ACP into routine nursing home care.,['Fourteen eligible nursing homes'],"['multicomponent ACP intervention', 'ACP', 'ACP+ programme', 'continue care and education as usual or to receive the ACP+ programme (a multicomponent programme which is delivered stepwise over an eight-month period with the help of an external trainer']","[""nursing home care staff's knowledge of, and self-efficacy regarding ACP"", ""1) nursing home care staff's attitudes towards ACP and ACP practices; 2) support staff's and volunteer's ACP practices and 3) support staff's and volunteers' self-efficacy""]","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0204977', 'cui_str': 'Home Care'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0038122', 'cui_str': 'Staff Attitude'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]",14.0,0.11675,We developed a theory-based multicomponent ACP intervention (the ACP+ programme) aimed at supporting nursing home staff with the implementation of ACP into routine nursing home care.,"[{'ForeName': 'Joni', 'Initials': 'J', 'LastName': 'Gilissen', 'Affiliation': 'End-of-life Care Research Group, Vrije Universiteit Brussel (VUB) & Ghent University, Laarbeeklaan 103, 1090, Brussels, Belgium. joni.gilissen@vub.be.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Pivodic', 'Affiliation': 'End-of-life Care Research Group, Vrije Universiteit Brussel (VUB) & Ghent University, Laarbeeklaan 103, 1090, Brussels, Belgium.'}, {'ForeName': 'Annelien', 'Initials': 'A', 'LastName': 'Wendrich-van Dael', 'Affiliation': 'End-of-life Care Research Group, Vrije Universiteit Brussel (VUB) & Ghent University, Laarbeeklaan 103, 1090, Brussels, Belgium.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Gastmans', 'Affiliation': 'Centre for Biomedical Ethics and Law, KU Leuven, Kapucijnenvoer 35 Box 7001, 3000, Leuven, Belgium.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Vander Stichele', 'Affiliation': 'Department of Pharmacology, Ghent University, De Pintelaan 185, 9000, Ghent, Belgium.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Engels', 'Affiliation': 'Department of Anaesthesiology, Pain and Palliative Care, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Myrra', 'Initials': 'M', 'LastName': 'Vernooij-Dassen', 'Affiliation': 'IQ Healthcare, Radboud Institute for Health Sciences, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Deliens', 'Affiliation': 'End-of-life Care Research Group, Vrije Universiteit Brussel (VUB) & Ghent University, Laarbeeklaan 103, 1090, Brussels, Belgium.'}, {'ForeName': 'Lieve', 'Initials': 'L', 'LastName': 'Van den Block', 'Affiliation': 'End-of-life Care Research Group, Vrije Universiteit Brussel (VUB) & Ghent University, Laarbeeklaan 103, 1090, Brussels, Belgium.'}]",BMC palliative care,['10.1186/s12904-019-0505-7']
1053,31924562,The effect of dulaglutide on stroke: an exploratory analysis of the REWIND trial.,"BACKGROUND


Cardiovascular outcome trials have suggested that glucagon-like peptide 1 (GLP-1) receptor agonists might reduce strokes. We analysed the effect of dulaglutide on stroke within the researching cardiovascular events with a weekly incretin in diabetes (REWIND) trial.
METHODS


REWIND was a multicentre, randomised, double-blind, placebo-controlled trial done at 371 sites in 24 countries. Men and women (aged ≥50 years) with established or newly detected type 2 diabetes whose HbA 1c  was 9·5% or less (with no lower limit) on stable doses of up to two oral glucose-lowering drugs with or without basal insulin therapy were eligible if their body-mass index was at least 23 kg/m 2 . Participants were randomly assigned (1:1) to weekly subcutaneous injections of either masked dulaglutide 1·5 mg or the same volume of masked placebo (containing the same excipients but without dulaglutide). Randomisation was done by a computer-generated random code with an interactive web response system with stratification by site. Participants, investigators, the trial leadership, and all other personnel were masked to treatment allocation until the trial was completed and the database was locked. During the treatment period, participants in both groups were instructed to inject study drug on the same day at around the same time, each week. Strokes were categorised as fatal or non-fatal, and as either ischaemic, haemorrhagic, or undetermined. Stroke severity was assessed using the modified Rankin scale. Participants were seen at 2 weeks, 3 months, 6 months, and then every 3 months for drug dispensing and every 6 months for detailed assessments, until 1200 confirmed primary outcomes accrued. The primary endpoint was the first occurrence of any component of the composite outcome, which comprised non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular or unknown causes. All analyses were done according to an intention-to-treat strategy that included all randomly assigned participants, irrespective of adherence. The trial is registered with ClinicalTrials.gov, number NCT01394952.
FINDINGS


Between Aug 18, 2011, and Aug 14, 2013, we screened 12 133 patients, of whom 9901 with type 2 diabetes and additional cardiovascular risk factors were randomly assigned to either dulaglutide (n=4949) or an equal volume of placebo (n=4952). During a median follow-up of 5·4 years, cerebrovascular and other cardiovascular outcomes were ascertained and adjudicated. 158 (3·2%) of 4949 participants assigned to dulaglutide and 205 (4·1%) of 4952 participants assigned to placebo had a stroke during follow-up (hazard ratio [HR] 0·76, 95% CI 0·62-0·94; p=0·010). Dulaglutide reduced ischaemic stroke (0·75, 0·59-0·94, p=0·012) but had no effect on haemorrhagic stroke (1·05, 0·55-1·99; p=0·89). Dulaglutide also reduced the composite of non-fatal stroke or all-cause death (0·88, 0·79-0·98; p=0·017) and disabling stroke (0·74, 0·56-0·99; p=0·042). The degree of disability after stroke did not differ by treatment group.
INTERPRETATION


Long-term dulaglutide use might reduce clinically relevant ischaemic stroke in people with type 2 diabetes but does not affect stroke severity.
FUNDING


Eli Lilly and Company.",2020,"Dulaglutide reduced ischaemic stroke (0·75, 0·59-0·94, p=0·012) but had no effect on haemorrhagic stroke (1·05, 0·55-1·99; p=0·89).","['158 (3·2%) of 4949 participants assigned to dulaglutide and 205 (4·1%) of 4952 participants assigned to', 'Between Aug 18, 2011, and Aug 14, 2013, we screened 12\u2008133 patients, of whom 9901 with type 2 diabetes and additional cardiovascular risk factors', '371 sites in 24 countries', 'people with type 2 diabetes', 'Men and women (aged ≥50 years) with established or newly detected type 2 diabetes whose HbA 1c  was 9·5% or less (with no lower limit) on stable doses of up to two oral glucose-lowering drugs with or without basal insulin therapy were eligible if their body-mass index was at least 23 kg/m 2 ']","['dulaglutide', 'dulaglutide (n=4949) or an equal volume of placebo', 'placebo', 'masked dulaglutide 1·5 mg or the same volume of masked placebo']","['stroke', 'first occurrence of any component of the composite outcome, which comprised non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular or unknown causes', 'composite of non-fatal stroke', 'Stroke severity', 'haemorrhagic stroke', 'Dulaglutide reduced ischaemic stroke', 'degree of disability after stroke', 'disabling stroke']","[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0024861', 'cui_str': 'Masks'}]","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0553692', 'cui_str': 'Haematencephalon'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",4949.0,0.730745,"Dulaglutide reduced ischaemic stroke (0·75, 0·59-0·94, p=0·012) but had no effect on haemorrhagic stroke (1·05, 0·55-1·99; p=0·89).","[{'ForeName': 'Hertzel C', 'Initials': 'HC', 'LastName': 'Gerstein', 'Affiliation': 'Population Health Research Institute, Hamilton, ON, Canada; Department of Medicine, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada. Electronic address: gerstein@mcmaster.ca.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hart', 'Affiliation': 'Population Health Research Institute, Hamilton, ON, Canada.'}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Colhoun', 'Affiliation': 'University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Clínicos Latino América, Rosario, Argentina.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lakshmanan', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Fady T', 'Initials': 'FT', 'LastName': 'Botros', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Probstfield', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Riddle', 'Affiliation': 'Department of Medicine, Oregon Health & Science University Portland, OR, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Rydén', 'Affiliation': 'Department of Medicine K2, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Charles Messan', 'Initials': 'CM', 'LastName': 'Atisso', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Dyal', 'Affiliation': 'Population Health Research Institute, Hamilton, ON, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Hall', 'Affiliation': 'Population Health Research Institute, Hamilton, ON, Canada.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Avezum', 'Affiliation': 'Hospital Alemão Oswaldo Cruz, São Paulo, Brazil.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Basile', 'Affiliation': 'Medical University of South Carolina, Ralph H Johnson VA Medical Center, Charleston, SC, USA.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Conget', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínic i Universitari, Barcelona, Spain.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Cushman', 'Affiliation': 'Memphis Veterans Affairs Medical Center, Memphis, TN, USA.'}, {'ForeName': 'Nicolae', 'Initials': 'N', 'LastName': 'Hancu', 'Affiliation': 'Department of Diabetes and Nutrition, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj Napoca, Romania.'}, {'ForeName': 'Markolf', 'Initials': 'M', 'LastName': 'Hanefeld', 'Affiliation': 'Department of Internal Medicine, Dresden Technical University, Dresden, Germany.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Jansky', 'Affiliation': 'University Hospital Motol, Prague, Czech Republic.'}, {'ForeName': 'Matyas', 'Initials': 'M', 'LastName': 'Keltai', 'Affiliation': 'Hungarian Institute of Cardiology, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Lanas', 'Affiliation': 'Department of Internal Medicine, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Patricio', 'Initials': 'P', 'LastName': 'Lopez-Jaramillo', 'Affiliation': 'Masira Research Institute, Medical School, Universidad de Santander UDES and FOSCAL, Bucaramanga, Colombia.'}, {'ForeName': 'Ernesto Germán Cardona', 'Initials': 'EGC', 'LastName': 'Muñoz', 'Affiliation': 'University Center of Health Sciences, Universidad de Guadalajara, Guadalajara, Mexico.'}, {'ForeName': 'Nana', 'Initials': 'N', 'LastName': 'Pogosova', 'Affiliation': 'National Medical Research Center of Cardiology, Moscow, Russia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Raubenheimer', 'Affiliation': 'Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Shaw', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, VIC, Australia.'}, {'ForeName': 'Wayne H-H', 'Initials': 'WH', 'LastName': 'Sheu', 'Affiliation': 'Taichung Veterans General Hospital, Taichung, Taiwan.'}, {'ForeName': 'Theodora', 'Initials': 'T', 'LastName': 'Temelkova-Kurktschiev', 'Affiliation': 'Robert Koch Medical Center, Sofia, Bulgaria.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30423-1']
1054,31790344,"Pembrolizumab As Second-Line Therapy in Patients With Advanced Hepatocellular Carcinoma in KEYNOTE-240: A Randomized, Double-Blind, Phase III Trial.","PURPOSE


Pembrolizumab demonstrated antitumor activity and safety in the phase II KEYNOTE-224 trial in previously treated patients with advanced hepatocellular carcinoma (HCC). KEYNOTE-240 evaluated the efficacy and safety of pembrolizumab in this population.
PATIENTS AND METHODS


This randomized, double-blind, phase III study was conducted at 119 medical centers in 27 countries. Eligible patients with advanced HCC, previously treated with sorafenib, were randomly assigned at a two-to-one ratio to receive pembrolizumab plus best supportive care (BSC) or placebo plus BSC. Primary end points were overall survival (OS) and progression-free survival (PFS; one-sided significance thresholds,  P  = .0174 [final analysis] and  P  = .002 [first interim analysis], respectively). Safety was assessed in all patients who received ≥ 1 dose of study drug.
RESULTS


Between May 31, 2016, and November 23, 2017, 413 patients were randomly assigned. As of January 2, 2019, median follow-up was 13.8 months for pembrolizumab and 10.6 months for placebo. Median OS was 13.9 months (95% CI, 11.6 to 16.0 months) for pembrolizumab versus 10.6 months (95% CI, 8.3 to 13.5 months) for placebo (hazard ratio [HR], 0.781; 95% CI, 0.611 to 0.998;  P  = .0238). Median PFS for pembrolizumab was 3.0 months (95% CI, 2.8 to 4.1 months) versus 2.8 months (95% CI, 2.5 to 4.1 months) for placebo at the first interim analysis (HR, 0.775; 95% CI, 0.609 to 0.987;  P  = .0186) and 3.0 months (95% CI, 2.8 to 4.1 months) versus 2.8 months (95% CI, 1.6 to 3.0 months) at final analysis (HR, 0.718; 95% CI, 0.570 to 0.904;  P  = .0022). Grade 3 or higher adverse events occurred in 147 (52.7%) and 62 patients (46.3%) for pembrolizumab versus placebo; those that were treatment related occurred in 52 (18.6%) and 10 patients (7.5%), respectively. No hepatitis C or B flares were identified.
CONCLUSION


In this study, OS and PFS did not reach statistical significance per specified criteria. The results are consistent with those of KEYNOTE-224, supporting a favorable risk-to-benefit ratio for pembrolizumab in this population.",2020,"Median OS was 13.9 months (95% CI, 11.6 to 16.0 months) for pembrolizumab versus 10.6 months (95% CI, 8.3 to 13.5 months) for placebo (hazard ratio [HR], 0.781; 95% CI, 0.611 to 0.998;  P  = .0238).","['Eligible patients with advanced HCC, previously treated with', 'Between May 31, 2016, and November 23, 2017, 413 patients were randomly assigned', '119 medical centers in 27 countries', 'previously treated patients with advanced hepatocellular carcinoma (HCC', 'Patients With Advanced Hepatocellular Carcinoma in KEYNOTE-240']","['Pembrolizumab As Second-Line Therapy', 'sorafenib', 'pembrolizumab', 'placebo', 'pembrolizumab plus best supportive care (BSC) or placebo plus BSC']","['antitumor activity and safety', 'hepatitis C or B flares', 'Safety', 'efficacy and safety', 'Median PFS for pembrolizumab', 'overall survival (OS) and progression-free survival (PFS; one-sided significance thresholds,  P  = .0174', 'Median OS', 'Grade 3 or higher adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",413.0,0.539673,"Median OS was 13.9 months (95% CI, 11.6 to 16.0 months) for pembrolizumab versus 10.6 months (95% CI, 8.3 to 13.5 months) for placebo (hazard ratio [HR], 0.781; 95% CI, 0.611 to 0.998;  P  = .0238).","[{'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Finn', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA.'}, {'ForeName': 'Baek-Yeol', 'Initials': 'BY', 'LastName': 'Ryoo', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Merle', 'Affiliation': 'Lyon North Hospital, Lyon, France.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': 'Kindai University Faculty of Medicine, Osaka, Japan.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Bouattour', 'Affiliation': 'Beaujon University Hospital, Assistance Publique-Hôpitaux de Paris, Clichy, France.'}, {'ForeName': 'Ho Yeong', 'Initials': 'HY', 'LastName': 'Lim', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Valeriy', 'Initials': 'V', 'LastName': 'Breder', 'Affiliation': 'NN Blokhin National Medical Research Center of Oncology, Ministry of Health, Moscow, Russian Federation.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Edeline', 'Affiliation': 'Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'Yee', 'Initials': 'Y', 'LastName': 'Chao', 'Affiliation': 'Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Sadahisa', 'Initials': 'S', 'LastName': 'Ogasawara', 'Affiliation': 'Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Yau', 'Affiliation': ""The University at Hong Kong, Hong Kong, People's Republic of China.""}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Garrido', 'Affiliation': 'Pontificia Universidad Catolica de Chile, Santiago, Chile.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Chan', 'Affiliation': ""State Key Laboratory of Translation Oncology, Sir YK Pao Centre for Cancer, The Chinese University of Hong Kong, Hong Kong, People's Republic of China.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Knox', 'Affiliation': 'Princess Margaret Cancer Centre and University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Daniele', 'Affiliation': 'Ospedale del Mare, Napoli, Italy.'}, {'ForeName': 'Scot W', 'Initials': 'SW', 'LastName': 'Ebbinghaus', 'Affiliation': 'Merck, Kenilworth, NJ.'}, {'ForeName': 'Erluo', 'Initials': 'E', 'LastName': 'Chen', 'Affiliation': 'Merck, Kenilworth, NJ.'}, {'ForeName': 'Abby B', 'Initials': 'AB', 'LastName': 'Siegel', 'Affiliation': 'Merck, Kenilworth, NJ.'}, {'ForeName': 'Andrew X', 'Initials': 'AX', 'LastName': 'Zhu', 'Affiliation': 'Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Ann-Lii', 'Initials': 'AL', 'LastName': 'Cheng', 'Affiliation': 'National Taiwan University Hospital and National Taiwan University Cancer Center, Taipei, Taiwan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01307']
1055,31804876,Treatment of Older Patients With Mantle Cell Lymphoma (MCL): Long-Term Follow-Up of the Randomized European MCL Elderly Trial.,"PURPOSE


In an update of the randomized, open-label, phase III European Mantle Cell Lymphoma (MCL) Elderly trial (ClinicalTrials.gov identifier: NCT00209209), published in 2012, we aimed to confirm results on long-term outcome focusing on efficacy and safety of long-term use of rituximab maintenance.
PATIENTS AND METHODS


Five hundred sixty patients with newly diagnosed MCL underwent a first random assignment between rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) and rituximab, fludarabine, and cyclophosphamide (R-FC) induction, followed by a second random assignment in 316 responders between rituximab and interferon alfa maintenance, to be continued until progression. We compared progression-free survival from the second randomization and overall survival (OS) from the first or second randomizations.
RESULTS


After a median follow-up time of 7.6 years, the previously described difference in OS between the induction arms persisted (median, 6.4 years after R-CHOP [n = 280]  v  3.9 years after R-FC [n = 280];  P  = .0054). Patients responding to R-CHOP had median progression-free survival and OS times of 5.4 and 9.8 years, respectively, when randomly assigned to rituximab (n = 87), compared with 1.9 years ( P  < .001) and 7.1 years ( P  = .0026), respectively, when randomly assigned to interferon alfa (n = 97). In 58% and 32% of patients treated with R-CHOP, rituximab maintenance was still ongoing 2 and 5 years from start of maintenance, respectively. After R-FC, rituximab maintenance was associated with an unexpectedly high cumulative incidence of death in remission (22% at 5 years). Toxicity of rituximab maintenance was low after R-CHOP (grade 3-4 leukopenia or infection < 5%) but more prominent in patients on rituximab maintenance after R-FC, in whom grade 3-4 leukopenia (up to 40%) and infections were frequent (up to 15%).
CONCLUSION


The excellent results of R-CHOP followed by rituximab maintenance until progression for older patients with MCL persisted in a mature follow-up. Prolongation of rituximab maintenance beyond 2 years is effective and safe.",2020,"Toxicity of rituximab maintenance was low after R-CHOP (grade 3-4 leukopenia or infection < 5%) but more prominent in patients on rituximab maintenance after R-FC, in whom grade 3-4 leukopenia (up to 40%) and infections were frequent (up to 15%).
","['Five hundred sixty patients with newly diagnosed MCL underwent a first random assignment between', 'older patients with MCL', 'Older Patients With Mantle Cell Lymphoma (MCL']","['rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) and rituximab, fludarabine, and cyclophosphamide (R-FC) induction', 'rituximab', 'rituximab maintenance', 'interferon alfa', 'rituximab and interferon alfa maintenance']","['leukopenia', 'efficacy and safety', 'median progression-free survival and OS times', 'overall survival (OS', 'OS', 'Toxicity of rituximab maintenance', 'progression-free survival']","[{'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0334634', 'cui_str': 'Lymphoma, Small-Cell, Centrocytic'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0059985', 'cui_str': 'fludarabine'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0002199', 'cui_str': 'Interferon, Lymphoblastoid'}]","[{'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]",560.0,0.0628039,"Toxicity of rituximab maintenance was low after R-CHOP (grade 3-4 leukopenia or infection < 5%) but more prominent in patients on rituximab maintenance after R-FC, in whom grade 3-4 leukopenia (up to 40%) and infections were frequent (up to 15%).
","[{'ForeName': 'Hanneke C', 'Initials': 'HC', 'LastName': 'Kluin-Nelemans', 'Affiliation': 'University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Hoster', 'Affiliation': 'University Hospital Ludwig-Maximilians-University Munich, Munich, Germany.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Hermine', 'Affiliation': 'Hôpital Necker, Institut Imagine, Assistance Publique-Hôpitaux de Paris, University Paris Descartes, Paris, France.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Walewski', 'Affiliation': 'Maria Sklodowska-Curie Institute, Warsaw, Poland.'}, {'ForeName': 'Christian H', 'Initials': 'CH', 'LastName': 'Geisler', 'Affiliation': 'Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Trneny', 'Affiliation': 'Charles University General Hospital, Prague, Czech Republic.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Stilgenbauer', 'Affiliation': 'University of Ulm, Ulm, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Kaiser', 'Affiliation': 'VK&K Studien GbR, Landshut, Germany.'}, {'ForeName': 'Jeanette K', 'Initials': 'JK', 'LastName': 'Doorduijn', 'Affiliation': 'Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Salles', 'Affiliation': 'Hospices Civils de Lyon, University of Lyon, Pierre-Benite, France.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Szymczyk', 'Affiliation': 'Maria Sklodowska-Curie Institute, Warsaw, Poland.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Tilly', 'Affiliation': 'Centre Henri Becquerel, Rouen, France.'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Kanz', 'Affiliation': 'University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schmidt', 'Affiliation': 'University Hospital Ludwig-Maximilians-University Munich, Munich, Germany.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Feugier', 'Affiliation': 'Center Hospitalier Regional and University Nancy Vandoeuvre les Nancy, Nancy, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Thieblemont', 'Affiliation': 'Hôpital Saint Louis, Paris, France.'}, {'ForeName': 'Josée M', 'Initials': 'JM', 'LastName': 'Zijlstra', 'Affiliation': 'Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Ribrag', 'Affiliation': 'Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Wolfram', 'Initials': 'W', 'LastName': 'Klapper', 'Affiliation': 'University of Kiel, Kiel, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Pott', 'Affiliation': 'University Hospital Schleswig-Holstein Campus Kiel/Christian-Albrechts University Kiel, Kiel, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Unterhalt', 'Affiliation': 'University Hospital Ludwig-Maximilians-University Munich, Munich, Germany.'}, {'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'Dreyling', 'Affiliation': 'University Hospital Ludwig-Maximilians-University Munich, Munich, Germany.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01294']
1056,31838780,Effectiveness of a music intervention on pruritus: an open randomized prospective study.,"BACKGROUND


Pruritus is a common symptom in many skin diseases. Music interventions have demonstrated their efficacy in different symptoms or diseases such as pain, depression and anxiety.
OBJECTIVE


To evaluate the effects of a music intervention on pruritus.
PATIENTS AND METHODS


A randomized controlled trial was conducted from November 2018 to April 2019. Fifty inpatients with pruritus intensity ≥3/10 in various chronic skin diseases were randomized in a music group or an emollient group. The primary endpoint was the evolution of pruritus as measured by the Numerical Rating Scale before and one hour after the procedure. The secondary judgement criteria were the effects on patient anxiety, the impact of pruritus on the quality of life and patient satisfaction (NCT03701971).
RESULTS


Fifty patients with chronic pruritus were included, 62% were male, and the average age was 60.7 years. The most common diseases were psoriasis (N = 10), atopic dermatitis (N = 8) and contact eczema (N = 6). The average ItchyQol score was 64.8/110, showing a significant impact on quality of life. The intensity of pruritus decreased more significantly in the music intervention group than in the emollient group: 2.3 (SD 2.1) and 1.2 (SD 1.7), respectively (P < 0.05). There was a decrease in anxiety in both groups, with no statistical significant difference between groups. Among patients who received the music intervention, 64% reported feeling an improvement, 91% would recommend the music intervention, and 64% would like to continue this practice.
DISCUSSION


Pruritus management is complex and requires first-line aetiological treatment. Aetiological or symptomatic treatments do not always provide enough relief; it is useful to find other therapeutic options. The music intervention has shown interest in our study. Its repeated use over the long term will be interesting to evaluate. As in pain, music may work by activating inhibitory neural circuits. The use of music is a simple method to manage chronic pruritus.",2020,"The intensity of pruritus decreased more significantly in the music intervention group than in the emollient group: 2.3 (SD 2.1) and 1.2 (SD 1.7), respectively (p<0.05).","['November 2018 to April 2019', 'Fifty inpatients with pruritus intensity ≥3/10 in various chronic skin diseases', 'Fifty patients with chronic pruritus were included, 62% were male, the average age was 60.7 years', 'psoriasis (N=10), atopic dermatitis (N=8), contact eczema (N=6']","['Music interventions', 'music group or an emollient group', 'music intervention']","['anxiety', 'pruritus', 'intensity of pruritus', 'average ItchyQol score', 'evolution of pruritus as measured by the Numerical Rating Scale', 'patient anxiety, the impact of pruritus on the quality of life, and patient satisfaction (NCT03701971', 'quality of life']","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1290009', 'cui_str': 'Chronic disease of skin'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0011616', 'cui_str': 'Sensitivity, Contact'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0013983', 'cui_str': 'Emollients'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}]",50.0,0.121684,"The intensity of pruritus decreased more significantly in the music intervention group than in the emollient group: 2.3 (SD 2.1) and 1.2 (SD 1.7), respectively (p<0.05).","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Demirtas', 'Affiliation': 'Dermatology department, University Hospital of Brest, Brest, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Houssais', 'Affiliation': 'Dermatology department, University Hospital of Brest, Brest, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Tanniou', 'Affiliation': 'Delegation of Clinical Research and Innovation, University Hospital of Brest, Brest, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Misery', 'Affiliation': 'Dermatology department, University Hospital of Brest, Brest, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Brenaut', 'Affiliation': 'Dermatology department, University Hospital of Brest, Brest, France.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16149']
1057,31860326,Sex-Specific Differential Responses of Circulating Biomarkers in Obstructive Sleep Apnea Treatment. A  Post Hoc  Analysis of a Randomized Controlled Trial.,"Rationale : Knowledge of sex-specific changes of cardiovascular biomarkers in response to continuous positive airway pressure (CPAP) therapy for obstructive sleep apnea (OSA) is limited. Objectives : We hypothesized a differential sex-specific cardiovascular biomarker response with CPAP therapy for OSA. Methods : Participants with moderate-severe OSA (apnea-hypopnea index, 15 events/h) were randomized to CPAP versus sham and completed polysomnography and collection of biomarkers of inflammation (myeloperoxidase, fibrinogen, paraoxonase, interleukin [IL]-6, IL-6 soluble receptor, aryl esterase, oxidized low-density lipoprotein, lipoprotein A, plasminogen activator inhibitor 1, and F 2 -isoprostane urine/creatinine ratio) and vascular measures at baseline and 8 weeks of therapy with either CPAP ( n  = 72) or sham treatment ( n  = 70).  Post hoc  secondary analyses of sex-study arm interaction relative to change in inflammatory biomarkers were evaluated via linear regression with adjustment for baseline biomarker value, age, race, body mass, index, waist circumference, and CPAP adherence. Interactions were further evaluated via sex-stratified analyses. Results : The study sample comprised a total of 149 participants aged 50.8 ± 11.7 years; 55% were male, and 55% were white. Participants had a median apnea-hypopnea index of 26.3 events per hour (interquartile range, 13-37). There were substantial interactions between study arm and sex for myeloperoxidase, paraoxonase, and fibrinogen ( P  = 0.03,  P  = 0.03, and  P  = 0.08, respectively). No significant interactions were found for the vascular measures. Estimates were similar but with decreased power in sex-stratified analyses, with decreased biomarkers in women and increased biomarkers in men. Conclusions : Differential sex-specific responses to CPAP therapy for OSA were observed for circulating inflammatory biomarkers, which persisted after adjustment for confounders. These findings set the stage for validation studies and, if confirmed, biochemical pathway elucidation to inform sex-specific personalized treatment approaches.Clinical trial registered with www.clinicaltrials.gov (NCT00607893).",2020,"CONCLUSIONS


Differential sex-specific responses to CPAP therapy for OSA were observed for circulating inflammatory biomarkers which persisted after adjustment for confounders.","['Participants with moderate-severe OSA(apnea-hypopnea index, AHI ≥ 15', '149 participants were aged 50.8±11.7 years, 55% male, 55% white with median AHI 26.3 (IQR:13-37', 'Obstructive Sleep Apnea Treatment', 'obstructive sleep apnea (OSA']","['continuous positive airway pressure (CPAP) therapy', 'CPAP', 'CPAP therapy']","['inflammation (myeloperoxidase, fibrinogen, paroxonase, interleukin(IL)-6, IL-6 soluble receptor, aryl esterase, oxidized LDL, lipoprotein A, plasminogen activator inhibitor-1, and F2-isoprostane urine to creatinine ratio) and vascular measures']","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C4517668', 'cui_str': 'Twenty-six point three'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0014894', 'cui_str': 'Esterases'}, {'cui': 'C0348035', 'cui_str': 'oxidized low density lipoprotein'}, {'cui': 'C0065058', 'cui_str': 'Lipoprotein Lp(a)'}, {'cui': 'C0030190', 'cui_str': 'SERPINE1 Protein'}, {'cui': 'C0949861', 'cui_str': 'F2-Isoprostanes'}, {'cui': 'C0042037'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0429854', 'cui_str': 'Vascular measure'}]",149.0,0.126066,"CONCLUSIONS


Differential sex-specific responses to CPAP therapy for OSA were observed for circulating inflammatory biomarkers which persisted after adjustment for confounders.","[{'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'May', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, VA Northeast Ohio Healthcare System, Cleveland, Ohio; and.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Quantitative Health Sciences, Lerner Research Institute.'}, {'ForeName': 'Kingman P', 'Initials': 'KP', 'LastName': 'Strohl', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, VA Northeast Ohio Healthcare System, Cleveland, Ohio; and.'}, {'ForeName': 'Harneet', 'Initials': 'H', 'LastName': 'Walia', 'Affiliation': 'Sleep Disorders Center, Neurologic Institute, Cleveland Clinic Lerner College of Medicine, Case Western Reserve University.'}, {'ForeName': 'Stan L', 'Initials': 'SL', 'LastName': 'Hazen', 'Affiliation': 'Department of Cellular and Molecular Medicine, Lerner Research Institute, and.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Mehra', 'Affiliation': 'Sleep Disorders Center, Neurologic Institute, Cleveland Clinic Lerner College of Medicine, Case Western Reserve University.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201908-593OC']
1058,30788810,Pretreatment with glucose-insulin-potassium improves ventricular performances after coronary artery bypass surgery: a randomized controlled trial.,"Heart failure is the main cause of poor outcome following open heart surgery and experimental studies have demonstrated that glucose-insulin-potassium (GIK) infusion exerts cardioprotective effects by reducing myocardial ischemia-reperfusion injuries. This randomized controlled trial was designed to assess the effects of GIK on left ventricular function in moderate-to-high risk patients undergoing on-pump isolated coronary artery bypass surgery (CABGS), or combined with aortic valve replacement. The primary outcomes were the effects of GIK on two- and three-dimensional left ventricular ejection fraction (2D and 3D-LVEF), and on transmitral flow propagation velocity (Vp), that occurred between the pre- and post-CPB periods. GIK administration was associated with favorable interaction effects (p < 0.001) on 2D-LVEF, 3D-LVEF and Vp changes over the study periods. In GIK pretreated patients (N = 54), 2-D and 3D-LVEF and Vp increased slightly during surgery (mean difference [MD] + 3.5%, 95% confidence interval [95% CI] - 0.2 to 7.1%, MD + 4.0%, 95% CI 0.6-7.4%, and MD + 22.2%, 95% CI 16.0-28.4%, respectively). In contrast, in the Placebo group (N = 46), 2D-and 3D-LVEF, as well as Vp all decreased after CPB (MD - 7.5% [- 11.6 to - 3.4%], MD - 12.0% [- 15.2 to - 8.8%] and MD - 21.3% [- 25.7 to - 16.9%], respectively). In conclusion, the administration of GIK resulted in better preservation of systolic and diastolic ventricular function in the early period following weaning from CPB.",2020,"GIK administration was associated with favorable interaction effects (p < 0.001) on 2D-LVEF, 3D-LVEF and Vp changes over the study periods.","['after coronary artery bypass surgery', 'moderate-to-high risk patients undergoing on-pump isolated coronary artery bypass surgery (CABGS), or combined with aortic valve replacement']","['Placebo', 'glucose-insulin-potassium (GIK) infusion', 'GIK', 'glucose-insulin-potassium']","['favorable interaction effects', 'ventricular performances', 'systolic and diastolic ventricular function', 'effects of GIK on two- and three-dimensional left ventricular ejection fraction (2D and 3D-LVEF), and on transmitral flow propagation velocity (Vp']","[{'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve (procedure)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0080309', 'cui_str': 'Ventricular Function'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}]",,0.276672,"GIK administration was associated with favorable interaction effects (p < 0.001) on 2D-LVEF, 3D-LVEF and Vp changes over the study periods.","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Licker', 'Affiliation': 'Department of Anaesthesiology, Pharmacology and Intensive Care, University Hospital of Geneva, Rue Gabrielle-Perret-Gentil 4, 1211, Geneva, Switzerland. marc-joseph.licker@hcuge.ch.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Reynaud', 'Affiliation': 'Department of Anaesthesiology, Pharmacology and Intensive Care, University Hospital of Geneva, Rue Gabrielle-Perret-Gentil 4, 1211, Geneva, Switzerland.'}, {'ForeName': 'Najia', 'Initials': 'N', 'LastName': 'Garofano', 'Affiliation': 'Department of Anaesthesiology, Pharmacology and Intensive Care, University Hospital of Geneva, Rue Gabrielle-Perret-Gentil 4, 1211, Geneva, Switzerland.'}, {'ForeName': 'Tornike', 'Initials': 'T', 'LastName': 'Sologashvili', 'Affiliation': 'Division of Cardiovascular Surgery, University Hospital of Geneva, Geneva, Switzerland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Diaper', 'Affiliation': 'Department of Anaesthesiology, Pharmacology and Intensive Care, University Hospital of Geneva, Rue Gabrielle-Perret-Gentil 4, 1211, Geneva, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Ellenberger', 'Affiliation': 'Department of Anaesthesiology, Pharmacology and Intensive Care, University Hospital of Geneva, Rue Gabrielle-Perret-Gentil 4, 1211, Geneva, Switzerland.'}]",Journal of clinical monitoring and computing,['10.1007/s10877-019-00280-5']
1059,31133558,Boosting Learning Efficacy with Noninvasive Brain Stimulation in Intact and Brain-Damaged Humans.,"Numerous behavioral studies have shown that visual function can improve with training, although perceptual refinements generally require weeks to months of training to attain. This, along with questions about long-term retention of learning, limits practical and clinical applications of many such paradigms. Here, we show for the first time in female and male human participants that just 10 d of visual training coupled with transcranial random noise stimulation (tRNS) over visual areas causes dramatic improvements in visual motion perception. Relative to control conditions and anodal stimulation, tRNS-enhanced learning was at least twice as fast, and, crucially, it persisted for 6 months after the end of training and stimulation. Notably, tRNS also boosted learning in patients with chronic cortical blindness, leading to recovery of motion processing in the blind field after just 10 d of training, a period too short to elicit enhancements with training alone. In sum, our results reveal a remarkable enhancement of the capacity for long-lasting plastic and restorative changes when a neuromodulatory intervention is coupled with visual training. SIGNIFICANCE STATEMENT  Our work demonstrates that visual training coupled with brain stimulation can dramatically reduce the training period from months to weeks, and lead to fast improvement in neurotypical subjects and chronic cortically blind patients, indicating the potential of our procedure to help restore damaged visual abilities for currently untreatable visual dysfunctions. Together, these results indicate the critical role of early visual areas in perceptual learning and reveal its capacity for long-lasting plastic changes promoted by neuromodulatory intervention.",2019,"Relative to control conditions and anodal stimulation, tRNS-enhanced learning was at least twice as fast, and, crucially, it persisted for 6 months after the end of training and stimulation.","['female and male human participants', 'patients with chronic cortical blindness', 'intact and brain-damaged humans']",['visual training coupled with transcranial random noise stimulation (tRNS'],['visual motion perception'],"[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0155320', 'cui_str': 'Blindness, Cortical'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0270611', 'cui_str': 'Brain Injuries'}]","[{'cui': 'C0200244', 'cui_str': 'Visual training'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C3852967', 'cui_str': 'Transcranial Random Noise Stimulation'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0026598', 'cui_str': 'Motion Perception'}]",,0.018975,"Relative to control conditions and anodal stimulation, tRNS-enhanced learning was at least twice as fast, and, crucially, it persisted for 6 months after the end of training and stimulation.","[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Herpich', 'Affiliation': 'Center for Neuroscience and Cognitive Systems@UniTn, Istituto Italiano di Tecnologia, 38068 Rovereto (TN), Italy.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Melnick', 'Affiliation': 'Department of Brain and Cognitive Sciences, Flaum Eye Institute and Center for Visual Science, University of Rochester, Rochester, New York 14642.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Agosta', 'Affiliation': 'Center for Neuroscience and Cognitive Systems@UniTn, Istituto Italiano di Tecnologia, 38068 Rovereto (TN), Italy.'}, {'ForeName': 'Krystel R', 'Initials': 'KR', 'LastName': 'Huxlin', 'Affiliation': 'Department of Brain and Cognitive Sciences, Flaum Eye Institute and Center for Visual Science, University of Rochester, Rochester, New York 14642.'}, {'ForeName': 'Duje', 'Initials': 'D', 'LastName': 'Tadin', 'Affiliation': 'Department of Brain and Cognitive Sciences, Flaum Eye Institute and Center for Visual Science, University of Rochester, Rochester, New York 14642.'}, {'ForeName': 'Lorella', 'Initials': 'L', 'LastName': 'Battelli', 'Affiliation': 'Center for Neuroscience and Cognitive Systems@UniTn, Istituto Italiano di Tecnologia, 38068 Rovereto (TN), Italy, Lorella.Battelli@iit.it.'}]",The Journal of neuroscience : the official journal of the Society for Neuroscience,['10.1523/JNEUROSCI.3248-18.2019']
1060,31919919,"Ixekizumab improves secondary lesional signs, pain and sexual health in patients with moderate-to-severe genital psoriasis.","BACKGROUND


Epithelial surface disruption in genital psoriatic lesions may manifest as erosions, fissures and/or ulcers, causing pain and significantly impacting a patient's sexual health.
OBJECTIVE


To evaluate the impact of erosions, fissures and/or ulcers in genital psoriatic lesions on pain and sexual activity in patients with moderate-to-severe genital psoriasis (GenPs) and treatment responses to ixekizumab vs. placebo until Week 12.
METHODS


This post hoc subgroup analysis of patients presenting with and without erosions, fissures and/or ulcers in genital lesions from a phase IIIb multicentre, randomized, double-blind, placebo-controlled study (IXORA-Q; NCT02718898) in 149 adults with moderate-to-severe GenPs treated with subcutaneous ixekizumab (80 mg every 2 weeks; n = 75) or placebo (n = 74) evaluated outcomes for clinician-rated GenPs severity (static Physician's Global Assessment of Genitalia; sPGA-G) and patient-reported genital pain and itch (Genital Psoriasis Symptoms Scale; GPSS) and sexual health (Genital Psoriasis Sexual Frequency Questionnaire; GenPs-SFQ).
RESULTS


At baseline, 38% (n = 57) of patients presented with genital erosions, fissures and/or ulcers independent of overall body surface area involvement (<10% or ≥10%). These signs were associated with higher scores for disease severity (sPGA-G) and pain (GPSS) but not sexual health (GenPs-SFQ). Complete resolution of these signs was observed in 62% of ixekizumab-treated patients (25% for placebo) at Week 1 and 83% (21% for placebo) at Week 12. Patients treated with ixekizumab reported significant improvements in pain, itch, disease severity and sexual health over 12 weeks compared to placebo and irrespective of the presence/absence of genital erosions, fissures and/or ulcers at baseline.
CONCLUSION


Ixekizumab led to rapid and sustained resolution of erosions, fissures and/or ulcers and significant improvements in GenPs severity, genital pain and sexual health. Ixekizumab may help to improve the well-being of patients with GenPs.",2020,"Patients treated with ixekizumab reported significant improvements in pain, itch, disease severity and sexual health over 12 weeks compared to placebo and irrespective of the presence/absence of genital erosions, fissures and/or ulcers at baseline.
","['patients with moderate-to-severe genital psoriasis', '80 mg every 2 weeks; n = 75) or', 'patients presenting with and without erosions, fissures and/or ulcers in genital lesions', '149 adults with moderate-to-severe GenPs treated with', 'patients with moderate-to-severe genital psoriasis (GenPs']","['Ixekizumab', 'ixekizumab', 'ixekizumab versus placebo', 'placebo', 'subcutaneous ixekizumab']","['secondary lesional signs, pain and sexual health', 'genital erosions, fissures and/or ulcers', 'disease severity (sPGA-G) and pain (GPSS', 'GenPs severity, genital pain and sexual health', ""clinician-rated GenPs severity (static Physician's Global Assessment of Genitalia; sPGA-G) and patient-reported genital pain and itch (Genital Psoriasis Symptoms Scale; GPSS) and sexual health (Genital Psoriasis Sexual Frequency Questionnaire; GenPs-SFQ"", 'pain, itch, disease severity and sexual health', 'Complete resolution of these signs', 'pain and sexual activity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer (morphologic abnormality)'}, {'cui': 'C0332469', 'cui_str': 'Fissured (qualifier value)'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0744369', 'cui_str': 'Lesion of genitalia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C1504460', 'cui_str': 'Genital erosion'}, {'cui': 'C0332469', 'cui_str': 'Fissured (qualifier value)'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0239725', 'cui_str': 'Genital pain'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0222045'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}]",149.0,0.198098,"Patients treated with ixekizumab reported significant improvements in pain, itch, disease severity and sexual health over 12 weeks compared to placebo and irrespective of the presence/absence of genital erosions, fissures and/or ulcers at baseline.
","[{'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Merola', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'P-D', 'Initials': 'PD', 'LastName': 'Ghislain', 'Affiliation': 'Department of Dermatology, Cliniques Saint-Luc, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'J N', 'Initials': 'JN', 'LastName': 'Dauendorffer', 'Affiliation': 'Department of Dermatology, Saint-Louis Hospital, Paris, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Potts Bleakman', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'A J M', 'Initials': 'AJM', 'LastName': 'Brnabic', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Burge', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Riedl', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16181']
1061,31743554,Novel topical skin hydration agent containing Anadenanthera colubrina polysaccharide-standardized herbal preparation.,"BACKGROUND


Hydration is an important factor to promote skin barrier function, metabolism, and appearance. In this process, the presence of aquaglyceroporins, envelope and lipid synthesis, and metabolism proteins are essential to provide greater corneocyte cohesion and to form a barrier avoiding transepidermal water loss.
OBJECTIVE


We evaluated the effects of a new topical pigment-free agent containing an Anadenanthera colubrina polysaccharide-rich dermocosmetic preparation (ACP) on the aquaporin-3 (AQP-3), filaggrin (FLG), involucrin (INV), glucocerebrosidase (GBA), and elongation of very-long-chain fatty acid (ELOVL) proteins production in skin human fragments, as well as on the transepidermal water loss in a double-blind placebo-controlled clinical trial.
METHODS


AQP3, FLG, INV, GBA, and ELOVL3 levels were measured by immunofluorescence analysis in human skin explants. Clinical trial was conducted to evaluate the effects of ACP 1% and ACP 3% on the transepidermal water loss (TEWL).
RESULTS


Image and statistical analysis showed that ACP 3% significantly increased at 90% the expression of AQP3. Similarly, ACP 3% was able to promote a significant increase of 68% and 51% in FLG and INV, respectively. ACP 3% produced no effects on the GBA and ELOVL3 proteins. Transepidermal water loss was significantly reduced in human volunteers under treatment with ACP 1% and ACP 3%.
CONCLUSION


ACP reduced transepidermal water loss in a clinical trial, promoting human skin hydration. These effects were related to modulation of the AQP3, FLG, and INV as evidenced by immunofluorescence assay. This way, A colubrina polysaccharide-rich phytopharmaceutical preparation is an effective additive product to skin hydration.",2020,"These effects were related to modulation of the AQP3, FLG, and INV as evidenced by immunofluorescence assay.",['human volunteers'],"['new topical pigment-free agent containing an Anadenanthera colubrina polysaccharide-rich dermocosmetic preparation (ACP', 'ACP']","['transepidermal water loss', 'aquaporin-3 (AQP-3), filaggrin (FLG), involucrin (INV), glucocerebrosidase (GBA), and elongation of very-long-chain fatty acid (ELOVL) proteins production', 'FLG, INV, GBA, and ELOVL3 levels', 'Transepidermal water loss', 'GBA and ELOVL3 proteins', 'transepidermal water loss (TEWL']","[{'cui': 'C0020155', 'cui_str': 'Human Volunteers'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0333610', 'cui_str': 'Pigmented (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1049796', 'cui_str': 'Colubrina'}, {'cui': 'C0032594', 'cui_str': 'Glycans'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}]","[{'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0256421', 'cui_str': 'AQP3 Protein'}, {'cui': 'C0117738', 'cui_str': 'Stratum corneum basic protein'}, {'cui': 'C0063740', 'cui_str': 'involucrin'}, {'cui': 'C0017768', 'cui_str': 'Acid beta-Glucosidase'}, {'cui': 'C0542549', 'cui_str': 'Very long chain fatty acid (substance)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0033268'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0332107,"These effects were related to modulation of the AQP3, FLG, and INV as evidenced by immunofluorescence assay.","[{'ForeName': 'Edson', 'Initials': 'E', 'LastName': 'Katekawa', 'Affiliation': 'Research and Development Department, Chemyunion Química Ltda, Sorocaba, Brazil.'}, {'ForeName': 'Jeanifer', 'Initials': 'J', 'LastName': 'Caverzan', 'Affiliation': 'Research and Development Department, Chemyunion Química Ltda, Sorocaba, Brazil.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Mussi', 'Affiliation': 'Research and Development Department, Chemyunion Química Ltda, Sorocaba, Brazil.'}, {'ForeName': 'Flavio B', 'Initials': 'FB', 'LastName': 'Camargo-Junior', 'Affiliation': 'Research and Development Department, Chemyunion Química Ltda, Sorocaba, Brazil.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Sufi', 'Affiliation': 'Research and Development Department, Chemyunion Química Ltda, Sorocaba, Brazil.'}, {'ForeName': 'Giovana', 'Initials': 'G', 'LastName': 'Padovani', 'Affiliation': 'Research and Development Department, Chemyunion Química Ltda, Sorocaba, Brazil.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Nazato', 'Affiliation': 'Research and Development Department, Chemyunion Química Ltda, Sorocaba, Brazil.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Nogueira', 'Affiliation': 'Research and Development Department, Chemyunion Química Ltda, Sorocaba, Brazil.'}, {'ForeName': 'Wagner V', 'Initials': 'WV', 'LastName': 'Magalhães', 'Affiliation': 'Research and Development Department, Chemyunion Química Ltda, Sorocaba, Brazil.'}, {'ForeName': 'Luiz C', 'Initials': 'LC', 'LastName': 'Di Stasi', 'Affiliation': 'Department of Pharmacology, Laboratory of Phytomedicines, Pharmacology and Biotechnology (PhytoPharmaTech), Institute of Biosciences, São Paulo State University (Unesp), Botucatu, Brazil.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13217']
1062,31680410,Assessment of changes in biophysical parameters by dermocosmetic emulgel loaded with Cinnamomum tamala extract: A split-faced and placebo-controlled study.,"BACKGROUND


Phenolic and flavonoid compounds found in plants alleviate the photo-damaging skin conditions by playing a major role in skin rejuvenation.
AIMS


The aim of the study was to explore the cosmeceutical effects of Cinnamomum tamala extract.
OBJECTIVE


Recent research was aimed to quantify phenols and flavonoids in the natural extract of C tamala leaves, to develop its phyto-cosmetic emulgel and to assess effects of emulgel on healthy human skin.
METHOD


Phenols and flavonoids in C tamala (CT) extract were quantified by using ELISA assay. Emulgel formulation loaded with 4% C tamala (CT emulgel) was developed, and its cosmetic effects were evaluated on the cheeks of 13 healthy female test volunteers by comparing with placebo (base). Facial parameters including melanin, erythema, sebum, and visible facial pores (size and area) were studied by using Mexameter ®  , Sebumeter ®  , and VisioFace ®  at regular interval for 90 days.
RESULTS


Total phenolic content and total flavonoids content of C tamala leaves extract were found to be 73.08 ± 0.0078 mg GAE/g and 52.63 ± 0.0060 mg QE/g CT extract respectively. As compared to placebo (base), CT emulgel was found to be significantly (P ≤ .05) effective in minimizing skin photo-damaging effects by reducing the levels of melanin, erythema, and sebum and size and count of both fine and large facial pores.
CONCLUSION


Cinnamomum tamala leaves extract, being a rich source of phenols and flavonoids minimized the photo-damaging effects by reducing skin melanin, erythema, and excess sebum; improving the skin imperfections by reducing facial pore count and area as assessed by advanced imaging and bioengineering techniques.",2020,"As compared to placebo (base), CT emulgel was found to be significantly (P ≤ .05) effective in minimizing skin photo-damaging effects by reducing the levels of melanin, erythema, and sebum and size and count of both fine and large facial pores.
","['healthy human skin', '13 healthy female test volunteers by comparing with']","['placebo', 'Cinnamomum tamala extract', 'Emulgel formulation loaded with 4% C\xa0tamala (CT emulgel']","['Facial parameters including melanin, erythema, sebum, and visible facial pores (size and area', 'levels of melanin, erythema, and sebum and size and count of both fine and large facial pores']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0969704', 'cui_str': 'Cinnamomum'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0025196', 'cui_str': 'Melanins'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0036511', 'cui_str': 'Sebum'}, {'cui': 'C0205379', 'cui_str': 'Visible (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0205232', 'cui_str': 'Fine (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]",,0.0264018,"As compared to placebo (base), CT emulgel was found to be significantly (P ≤ .05) effective in minimizing skin photo-damaging effects by reducing the levels of melanin, erythema, and sebum and size and count of both fine and large facial pores.
","[{'ForeName': 'Wajeeha', 'Initials': 'W', 'LastName': 'Arshad', 'Affiliation': 'Faculty of Pharmacy and Alternative Medicine, The Islamia University of Bahawalpur, Bahawalpur, Pakistan.'}, {'ForeName': 'Haji Muhammad Shoaib', 'Initials': 'HMS', 'LastName': 'Khan', 'Affiliation': 'Faculty of Pharmacy and Alternative Medicine, The Islamia University of Bahawalpur, Bahawalpur, Pakistan.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Akhtar', 'Affiliation': 'Faculty of Pharmacy and Alternative Medicine, The Islamia University of Bahawalpur, Bahawalpur, Pakistan.'}, {'ForeName': 'Mehwish', 'Initials': 'M', 'LastName': 'Nawaz', 'Affiliation': 'Faculty of Pharmacy and Alternative Medicine, The Islamia University of Bahawalpur, Bahawalpur, Pakistan.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13198']
1063,30788809,Positive end-expiratory pressure increases arterial oxygenation in elderly patients undergoing urological surgery using laryngeal mask airway in lithotomy position.,"Elderly patients undergoing urological surgery in the lithotomy position may be vulnerable to perioperative hypoxemia. Positive end-expiratory pressure (PEEP) can improve arterial oxygenation. Although laryngeal mask airway (LMA) is widely utilized in urological surgery, it is not known how PEEP affects arterial oxygenation in these patients. We, therefore, evaluated the effect of PEEP on arterial oxygen partial pressure (PaO 2 ) in elderly patients using LMA during urological surgery in the lithotomy position. Patients randomly received zero end-expiratory pressure (group Z, n = 34) or PEEP of 7 cmH 2 O (group P, n = 33). Ventilatory, respiratory, and haemodynamic variables were measured at 5 min (T0), 30 min (T1), and 60 min (T2) after LMA Supreme™ (sLMA) insertion. The primary outcome was the difference of PaO 2  at T2 between the two groups. Atelectasis score, the incidence of a significant leak, and complications associated with sLMA insertion were also evaluated. PaO 2  at T2 was significantly higher in group P than in group Z (20.0 ± 4.9 vs. 14.7 ± 3.7 kPa, P < 0.001). Atelectasis score at T2 was lower in group P than in group Z (5.3 ± 1.7 vs. 8.4 ± 2.3, P < 0.001). However, the incidence of a significant leak and complications associated with LMA insertion did not significantly differ between the two groups. PEEP can improve arterial oxygenation and reduce atelectasis in elderly patients using sLMA during urological surgery in the lithotomy position, suggesting that PEEP may be useful for elderly patients with an increased risk of perioperative hypoxemia when using sLMA.",2020,"However, the incidence of a significant leak and complications associated with LMA insertion did not significantly differ between the two groups.","['elderly patients using', 'Elderly patients undergoing', 'elderly patients using LMA during urological surgery in the lithotomy position', 'elderly patients undergoing urological surgery using laryngeal mask airway in lithotomy position']","['PEEP', 'urological surgery', 'laryngeal mask airway (LMA', 'zero end-expiratory pressure', 'sLMA', 'Positive end-expiratory pressure']","['arterial oxygenation and reduce atelectasis', 'Positive end-expiratory pressure (PEEP', 'Ventilatory, respiratory, and haemodynamic variables', 'Atelectasis score', 'arterial oxygen partial pressure (PaO 2 ', 'Atelectasis score, the incidence of a significant leak, and complications associated with sLMA insertion', 'perioperative hypoxemia']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0150665', 'cui_str': 'Lithotomy position (finding)'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}]","[{'cui': 'C0863179', 'cui_str': 'Peeping'}, {'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}, {'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}, {'cui': 'C0428720', 'cui_str': 'End-expiratory pressure'}, {'cui': 'C3494516', 'cui_str': 'Positive end expiratory pressure (observable entity)'}]","[{'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0004144', 'cui_str': 'Lung Collapse'}, {'cui': 'C3494516', 'cui_str': 'Positive end expiratory pressure (observable entity)'}, {'cui': 'C0863179', 'cui_str': 'Peeping'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0332234', 'cui_str': 'Leaking (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}]",,0.1456,"However, the incidence of a significant leak and complications associated with LMA insertion did not significantly differ between the two groups.","[{'ForeName': 'Doo-Hwan', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea.'}, {'ForeName': 'Jun-Young', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea.'}, {'ForeName': 'Jihion', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea.'}, {'ForeName': 'Gi-Ho', 'Initials': 'GH', 'LastName': 'Koh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea.'}, {'ForeName': 'Eunkyul', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea.'}, {'ForeName': 'Jai-Hyun', 'Initials': 'JH', 'LastName': 'Hwang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea.'}, {'ForeName': 'Young-Kug', 'Initials': 'YK', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea. kyk@amc.seoul.kr.'}]",Journal of clinical monitoring and computing,['10.1007/s10877-019-00281-4']
1064,31906955,"Comprehensive assessments and related interventions to enhance the long-term outcomes of child, adolescent and young adult cancer survivors - presentation of the CARE for CAYA-Program study protocol and associated literature review.","BACKGROUND


Improved, multimodal treatment strategies have been shown to increase cure rates in cancer patients. Those who survive cancer as a child, adolescent or young adult (CAYA), are at a higher risk for therapy-, or disease-related, late or long-term effects. The CARE for CAYA-Program has been developed to comprehensively assess any potential future problems, to offer need-based preventative interventions and thus to improve long-term outcomes in this particularly vulnerable population.
METHODS


The trial is designed as an adaptive trial with an annual comprehensive assessment followed by needs stratified, modular interventions, currently including physical activity, nutrition and psycho-oncology, all aimed at improving the lifestyle and/or the psychosocial situation of the patients. Patients, aged 15-39 years old, with a prior cancer diagnosis, who have completed tumour therapy and are in follow-up care, and who are tumour free, will be included. At baseline (and subsequently on an annual basis) the current medical and psychosocial situation and lifestyle of the participants will be assessed using a survey compiled of various validated questionnaires (e.g. EORTC QLQ C30, NCCN distress thermometer, PHQ-4, BSA, nutrition protocol) and objective parameters (e.g. BMI, WHR, co-morbidities like hyperlipidaemia, hypertension, diabetes), followed by basic care (psychological and lifestyle consultation). Depending on their needs, CAYAs will be allocated to preventative interventions in the above-mentioned modules over a 12-month period. After 1 year, the assessment will be repeated, and further interventions may be applied as needed. During the initial trial phase, the efficacy of this approach will be compared to standard care (waiting list with intervention in the following year) in a randomized study. During this phase, 530 CAYAs will be included and 320 eligible CAYAs who are willing to participate in the interventions will be randomly allocated to an intervention. Overall, 1500 CAYAs will be included and assessed. The programme is financed by the innovation fund of the German Federal Joint Committee and will be conducted at 14 German sites. Recruitment began in January 2018.
DISCUSSION


CAYAs are at high risk for long-term sequelae. Providing structured interventions to improve lifestyle and psychological situation may counteract against these risk factors. The programme serves to establish uniform regular comprehensive assessments and need-based interventions to improve long-term outcome in CAYA survivors.
TRIAL REGISTRATION


Registered at the German Clinical Trial Register (ID: DRKS00012504, registration date: 19th January 2018).",2020,"The programme serves to establish uniform regular comprehensive assessments and need-based interventions to improve long-term outcome in CAYA survivors.
","['Patients, aged 15-39\u2009years old, with a prior cancer diagnosis, who have completed tumour therapy and are in follow-up care, and who are tumour free, will be included', 'child, adolescent and young adult cancer survivors', '530 CAYAs will be included and 320 eligible CAYAs who are willing to participate in the interventions', 'cancer patients']",[],['cure rates'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C4517711', 'cui_str': '320 (qualifier value)'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}]",[],[],,0.0752867,"The programme serves to establish uniform regular comprehensive assessments and need-based interventions to improve long-term outcome in CAYA survivors.
","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Salchow', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Hamburg, Germany. j.salchow@uke.de.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mann', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Koch', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'von Grundherr', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Jensen', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Elmers', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Straub', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Vettorazzi', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Escherich', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rutkowski', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dwinger', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bergelt', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sokalska-Duhme', 'Affiliation': 'Klinikum Stuttgart, Olgahospital, Stuttgart, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bielack', 'Affiliation': 'Klinikum Stuttgart, Olgahospital, Stuttgart, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Calaminus', 'Affiliation': 'University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Baust', 'Affiliation': 'University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'C F', 'Initials': 'CF', 'LastName': 'Classen', 'Affiliation': 'University Hospital Rostock, Rostock, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rössig', 'Affiliation': ""University Children's Hospital Münster, Münster, Germany.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Faber', 'Affiliation': 'Mainz University Medical Center, Mainz, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Faller', 'Affiliation': 'University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Hilgendorf', 'Affiliation': 'University Hospital Jena, Jena, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gebauer', 'Affiliation': 'University Hospital of Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Langer', 'Affiliation': 'University Hospital of Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Metzler', 'Affiliation': 'University Hospital Erlangen, Erlangen, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Schuster', 'Affiliation': 'University Hospital Erlangen, Erlangen, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Niemeyer', 'Affiliation': 'Medical Centre, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Puzik', 'Affiliation': 'Medical Centre, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Reinhardt', 'Affiliation': 'University Hospital Essen, Essen, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Dirksen', 'Affiliation': 'University Hospital Essen, Essen, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sander', 'Affiliation': 'Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Köhler', 'Affiliation': 'Medical Faculty University Hospital Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Habermann', 'Affiliation': 'University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bokemeyer', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Stein', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",BMC cancer,['10.1186/s12885-019-6492-5']
1065,31808151,Reversal of neuromuscular blockade with sugammadex during continuous administration of anaesthetic agents: a double-blind randomised crossover study using the bispectral index.,"Sugammadex, a specific reversal agent for steroidal neuromuscular blocking drugs, has on occasion been reported to be associated with clinical signs of awakening. We performed a study to systematically search for an increase in bispectral index values and signs of awakening in patients maintained under general anaesthesia following sugammadex administration. Patients, scheduled to receive general anaesthesia with neuromuscular blockade, were included in this double-blind randomised crossover study. After surgery was completed, and while the train-of-four ratio was zero, intravenous anaesthesia was continued with the aim of maintaining the bispectral index in the range of 40-60. Patients then received either sugammadex 4 mg.kg -1  or saline. In cases of incomplete reversal of neuromuscular blockade after 5 min, patients received the other drug. Bispectral index and train-of-four monitoring were recorded every minute and clinical signs of awakening noted. Fifty-one patients completed the study. Median (IQR [range]) bispectral index values increased after sugammadex administration from 49 (43-53 [38-64]) to 63 (53-80 [45-97]) (p < 0.01) with an increase of ≥ 20 in 22 patients; 14 (27%) patients had clinical signs of awakening. Saline had no effect on bispectral index values, clinical signs of awakening or degree of neuromuscular blockade. This study confirms that reversal of neuromuscular blockade with sugammadex may be associated with clinical signs of awakening despite maintenance of anaesthesia. Intravenous anaesthesia should be maintained until complete recovery of muscle function is achieved, especially when sugammadex is administered.",2020,"Saline had no effect on bispectral index values, clinical signs of awakening or degree of neuromuscular blockade.","['Fifty-one patients completed the study', 'patients maintained under general anaesthesia following sugammadex administration', 'Patients, scheduled to receive general anaesthesia with neuromuscular blockade']","['sugammadex', 'sugammadex 4\xa0mg.kg -1  or saline', 'anaesthetic agents', 'Sugammadex', 'Saline']","['bispectral index values', 'clinical signs of awakening', 'Median (IQR [range', 'bispectral index values and signs of awakening', 'bispectral index values, clinical signs of awakening or degree of neuromuscular blockade', 'Bispectral index and train-of-four monitoring']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0235062', 'cui_str': 'Neuromuscular Block'}]","[{'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0002932', 'cui_str': 'Anesthetic Drugs'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0235062', 'cui_str': 'Neuromuscular Block'}, {'cui': 'C1301770', 'cui_str': 'Train-of-Four Monitoring'}]",51.0,0.555859,"Saline had no effect on bispectral index values, clinical signs of awakening or degree of neuromuscular blockade.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Le Guen', 'Affiliation': 'Department of Anaesthesiology, Hospital Foch, Suresnes and University Versailles, Saint-Quentin en Yvelines, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Roussel', 'Affiliation': 'Department of Anaesthesiology, Hospital Foch, Suresnes and University Versailles, Saint-Quentin en Yvelines, France.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Chazot', 'Affiliation': 'Department of Anaesthesiology, Hospital Foch, Suresnes and University Versailles, Saint-Quentin en Yvelines, France.'}, {'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'Dumont', 'Affiliation': 'Department of Electrical and Computer Engineering, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Liu', 'Affiliation': 'Department of Anaesthesiology, Hospital Foch, Suresnes and University Versailles, Saint-Quentin en Yvelines, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fischler', 'Affiliation': 'Department of Anaesthesiology, Hospital Foch, Suresnes and University Versailles, Saint-Quentin en Yvelines, France.'}]",Anaesthesia,['10.1111/anae.14897']
1066,31680053,Study of the safety of oral Triphala aqueous extract on healthy volunteers.,"BACKGROUND


Triphala extract is a well known medicinal herbal formula which is usually prescribed by Thai traditional doctors to adjust the physiological functions of the body. Previous studies have reported that Triphala has antioxidant, anti-inflammatory, antihypercholesterolemia and anticancer properties. Though this herbal recipe is commonly used in Thailand, its human safety, especially in the oral form, has not been studied. We therefore conducted a clinical trial (Phase I).
OBJECTIVE


This study evaluated the safety of administering the aqueous extract of Triphala to healthy volunteers at 2500 mg/d.
DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS


An open-label, single-arm trial was conducted at Chulabhorn International College of Medicine, Thammasat University, Pathum Thani, Thailand, between July 2017 and July 2018. The study enrolled 10 male and 10 female healthy volunteers; all were given Triphala (water extract; five capsules of 500 mg each) orally, once a day, at bedtime, for four consecutive weeks.
MAIN OUTCOME MEASURES


Signs and symptoms, physical examinations, hematology and blood chemistry were assessed at the beginning of the trial and every week thereafter, for four consecutive weeks. After finishing the trial, on day 28, all volunteers were invited to a follow-up session on day 35 to evaluate the safety of the herbal recipe using the same measurements.
RESULTS


At the oral dose of 2500 mg/d, Triphala had no serious adverse effects in healthy volunteers. Moreover, it was found to have significantly improved the volunteers' high-density lipoprotein cholesterol (HDL-C) levels on day 35 and also reduced their blood sugar levels on days 14 and 35.
CONCLUSIONS


We conclude that aqueous extract of Triphala is safe for healthy volunteers and that it elevates HDL-C levels and lowers blood sugar. Further clinical study should investigate its effects on HDL-C and blood sugar levels among the dyslipidemic and prediabetic groups.
TRIAL REGISTRATION


This trial was registered in the Thai Clinical Trial Registry with the identifier TCTR20180423002.",2020,"Moreover, it was found to have significantly improved the volunteers' high-density lipoprotein cholesterol (HDL-C) levels on day 35 and also reduced their blood sugar levels on days 14 and 35.
","['Triphala to healthy volunteers at 2500\u202fmg/d', 'Chulabhorn International College of Medicine, Thammasat University, Pathum Thani, Thailand, between July 2017 and July 2018', '10 male and 10 female healthy volunteers', 'healthy volunteers']",['oral Triphala aqueous extract'],"['Signs and symptoms, physical examinations, hematology and blood chemistry', 'blood sugar levels', 'serious adverse effects', ""volunteers' high-density lipoprotein cholesterol (HDL-C) levels"", 'HDL-C and blood sugar levels', 'HDL-C levels and lowers blood sugar']","[{'cui': 'C1958185', 'cui_str': 'triphala'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4319601', 'cui_str': '2500 (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1958185', 'cui_str': 'triphala'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}]","[{'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0005774', 'cui_str': 'Blood Chemical Analysis'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood (procedure)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}]",10.0,0.0507009,"Moreover, it was found to have significantly improved the volunteers' high-density lipoprotein cholesterol (HDL-C) levels on day 35 and also reduced their blood sugar levels on days 14 and 35.
","[{'ForeName': 'Pratya', 'Initials': 'P', 'LastName': 'Phetkate', 'Affiliation': 'Graduate Program in Integrative Medicine, Chulabhorn International College of Medicine, Thammasat University, Pathum Thani 12120, Thailand.'}, {'ForeName': 'Tanawan', 'Initials': 'T', 'LastName': 'Kummalue', 'Affiliation': 'Department of Clinical Pathology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand.'}, {'ForeName': 'Prasob-Orn', 'Initials': 'PO', 'LastName': 'Rinthong', 'Affiliation': 'Pharmaceutical Chemistry and Natural Products Research Unit, Faculty of Pharmacy, Mahasarakham University, Maha Sarakham 44150, Thailand.'}, {'ForeName': 'Somboon', 'Initials': 'S', 'LastName': 'Kietinun', 'Affiliation': 'Graduate Program in Integrative Medicine, Chulabhorn International College of Medicine, Thammasat University, Pathum Thani 12120, Thailand.'}, {'ForeName': 'Kusuma', 'Initials': 'K', 'LastName': 'Sriyakul', 'Affiliation': 'Graduate Program in Integrative Medicine, Chulabhorn International College of Medicine, Thammasat University, Pathum Thani 12120, Thailand. Electronic address: kusuma-s@tu.ac.th.'}]",Journal of integrative medicine,['10.1016/j.joim.2019.10.002']
1067,31070860,Cellular versus acellular matrix devices in the treatment of diabetic foot ulcers: Interim results of a comparative efficacy randomized controlled trial.,"Healing of diabetic foot ulcers is a major challenge. Despite adhering to optimal standard of care (SOC), less than 30% of wounds heal after 20 weeks. Advanced cellular tissue-based products have shown better healing over SOC, albeit with great cost and modest improvement. We hypothesized no difference in healing effected by either cellular (Dermagraft), noncellular (Oasis) devices, relative to SOC in treating diabetic foot ulcer in a randomized controlled trial. The primary and secondary outcomes were the percentage of subjects that achieved complete wound closure by study endpoint (12 weeks of treatment) and study completion, respectively. During the 2-week screening phase with SOC, subjects with 40% change in ulcer size were excluded. After randomization, 56 patients entered an active treatment phase (8 weeks) followed by a maintenance phase (4-week SOC), with endpoint at visit 15, and 4 monthly follow-up visits. There was equal distribution of demographic data (p>.05) and no difference in initial wound characteristics (p>.05) between all groups. No differences were observed in complete wound closure by 12 and 28 weeks of treatment, nor were there any difference in percentage area reduction from treatment weeks 1 to 12 and from treatment weeks 1 to 28 between the groups. Each of the treatment arms showed statistically significant reduction in wound area from treatment weeks 1 to 28 (p<.05). This exploratory analysis suggests that the outcomes of treatment with either Dermagraft or Oasis matrix are comparable. We have completed enrollment, and the final data analysis is underway to make definitive conclusions.",2019,"No differences were observed in complete wound closure by 12 and 28 weeks of treatment, nor were there any difference in percentage area reduction from treatment week 1 to 12, and from treatment week 1 to 28 between the groups.","['diabetic foot ulcers (DFU', 'Diabetic Foot Ulcers']",['Cellular versus Acellular Matrix Devices'],"['complete wound closure', 'percentage area reduction', 'percentage of subjects that achieved complete wound closure', 'ulcer size']","[{'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer (disorder)'}]","[{'cui': 'C4319583', 'cui_str': 'Matrix'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure (attribute)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}]",56.0,0.0794281,"No differences were observed in complete wound closure by 12 and 28 weeks of treatment, nor were there any difference in percentage area reduction from treatment week 1 to 12, and from treatment week 1 to 28 between the groups.","[{'ForeName': 'Catherine N', 'Initials': 'CN', 'LastName': 'Tchanque-Fossuo', 'Affiliation': 'Department of Dermatology, University of California Davis Medical Center, Sacramento, California.'}, {'ForeName': 'Sara E', 'Initials': 'SE', 'LastName': 'Dahle', 'Affiliation': 'Department of Dermatology, University of California Davis Medical Center, Sacramento, California.'}, {'ForeName': 'Hadar', 'Initials': 'H', 'LastName': 'Lev-Tov', 'Affiliation': 'Department of Dermatology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Kaitlyn I M', 'Initials': 'KIM', 'LastName': 'West', 'Affiliation': 'Dermatology Service, Sacramento VA Medical Center, VA Northern California Health Care System, Mather, California.'}, {'ForeName': 'Chin-Shang', 'Initials': 'CS', 'LastName': 'Li', 'Affiliation': 'Division of Biostatistics, Department of Public Health Sciences, University of California, Davis, California.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Rocke', 'Affiliation': 'Division of Biostatistics, Department of Public Health Sciences, University of California, Davis, California.'}, {'ForeName': 'Rivkah R', 'Initials': 'RR', 'LastName': 'Isseroff', 'Affiliation': 'Department of Dermatology, University of California Davis Medical Center, Sacramento, California.'}]",Journal of tissue engineering and regenerative medicine,['10.1002/term.2884']
1068,31504693,Lipolysis and Fat Oxidation Are Not Altered with Presleep Compared with Daytime Casein Protein Intake in Resistance-Trained Women.,"BACKGROUND


To date, no studies have directly compared the differences between presleep and daytime protein (PRO) consumption on localized and systemic fat metabolism in active women.
OBJECTIVE


The purpose of this study was to assess the effects of presleep compared with daytime PRO supplementation on subcutaneous abdominal adipose tissue (SCAAT) lipolysis and whole-body substrate utilization in women.
METHODS


Thirteen young (mean ± SE age: 22 ± 1 y; BMI: 24.3 ± 0.8 kg/m2), resistance-trained [1 repetition maximum (1RM) squat percentage of body weight: 135% ± 6%; 1RM bench press percentage of body weight: 82% ± 4%] women volunteered. On overnight experimental visits, participants performed full-body resistance exercise (RE; 65% 1RM) and were randomly assigned to consume either daytime PRO (PRO, 30 g casein) 30 min post-RE and presleep (30 min before bed) noncaloric, sensory-matched placebo (PLA, 0 g casein) (PRO-PLA), or the opposite (PLA-PRO), switching the order of the supplements on the following visit. SCAAT lipolysis, resting metabolism (indirect calorimetry), and plasma biomarkers (glucose, insulin, nonesterified fatty acids, glycerol) were measured at baseline, overnight, and the next morning.
RESULTS


There were no differences in overnight SCAAT lipolysis between conditions indicated by interstitial glycerol concentrations (PRO-PLA: baseline, 669 ± 137; next morning, 321 ± 77.1; PLA-PRO: baseline, 524 ± 109; next morning, 333 ± 68.0 μM), fat oxidation (PRO-PLA: baseline, 5.70 ± 0.35; next morning, 5.00 ± 0.28; PLA-PRO: baseline, 6.59 ± 0.32; next morning, 5.44 ± 0.27 g/min), or any other measure.
CONCLUSIONS


There was no difference between the effects of daytime and presleep PRO supplementation on SCAAT lipolysis or whole-body substrate utilization in resistance-trained women. Presleep PRO is a viable option for increasing PRO consumption in resistance-trained women because it does not blunt overnight lipolysis, and will therefore likely not lead to increases in subcutaneous abdominal fat.This trial was registered at clinicaltrials.gov as NCT03573687.",2020,There was no difference between the effects of daytime and presleep PRO supplementation on SCAAT lipolysis or whole-body substrate utilization in resistance-trained women.,"['women volunteered', 'Thirteen', 'women', 'Resistance-Trained Women', 'young (mean\xa0±\xa0SE age: 22\xa0±\xa01 y; BMI: 24.3\xa0±\xa00.8 kg/m2), resistance-trained [1 repetition maximum (1RM) squat percentage of body weight: 135%\xa0±\xa06%; 1RM bench press percentage of body weight: 82%\xa0±\xa04', 'active women']","['daytime PRO supplementation', 'noncaloric, sensory-matched placebo (PLA, 0 g casein) (PRO-PLA', 'daytime PRO (PRO, 30 g casein', 'Daytime Casein Protein Intake']","['subcutaneous abdominal adipose tissue (SCAAT) lipolysis and whole-body substrate utilization', 'SCAAT lipolysis, resting metabolism (indirect calorimetry), and plasma biomarkers (glucose, insulin, nonesterified fatty acids, glycerol', 'fat oxidation ', 'overnight SCAAT lipolysis']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0454326', 'cui_str': 'Bench press (regime/therapy)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]","[{'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C1563742', 'cui_str': 'Abdominal Fat'}, {'cui': 'C0023796', 'cui_str': 'Lipolysis'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0006781', 'cui_str': 'Calorimetry, Respiration'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}]",13.0,0.188794,There was no difference between the effects of daytime and presleep PRO supplementation on SCAAT lipolysis or whole-body substrate utilization in resistance-trained women.,"[{'ForeName': 'Brittany R', 'Initials': 'BR', 'LastName': 'Allman', 'Affiliation': 'Institute of Sports Sciences and Medicine, Department of Nutrition, Food and Exercise Sciences, Florida State University, Tallahassee, FL, USA.'}, {'ForeName': 'Margaret C', 'Initials': 'MC', 'LastName': 'Morrissey', 'Affiliation': 'Korey Stringer Institute, Department of Kinesiology, University of Connecticut, Storrs, CT, USA.'}, {'ForeName': 'Jeong-Su', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Institute of Sports Sciences and Medicine, Department of Nutrition, Food and Exercise Sciences, Florida State University, Tallahassee, FL, USA.'}, {'ForeName': 'Lynn B', 'Initials': 'LB', 'LastName': 'Panton', 'Affiliation': 'Institute of Sports Sciences and Medicine, Department of Nutrition, Food and Exercise Sciences, Florida State University, Tallahassee, FL, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Contreras', 'Affiliation': 'Department of Psychology, Florida State University, Tallahassee, FL, USA.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Hickner', 'Affiliation': 'Institute of Sports Sciences and Medicine, Department of Nutrition, Food and Exercise Sciences, Florida State University, Tallahassee, FL, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Ormsbee', 'Affiliation': 'Institute of Sports Sciences and Medicine, Department of Nutrition, Food and Exercise Sciences, Florida State University, Tallahassee, FL, USA.'}]",The Journal of nutrition,['10.1093/jn/nxz186']
1069,31828841,Randomised trial showed that rapid rehydration of severely malnourished children with dehydrating diarrhoea was as safe and effective as slow rehydration.,"AIM


This study evaluated the effectiveness and safety of rapid and slow rehydration in children aged 6-60 months with dehydrating diarrhoea and severe malnutrition.
METHODS


A randomised controlled trial was conducted from July 2011 to March 2014 at the International Centre for Diarrhoeal Disease Research Bangladesh. We included children with weight for age and, or, weight for length Z-scores of less than -3 or with bipedal oedema and acute diarrhoea with severe dehydration. The children received intravenous fluid at different rates: 105 rapidly over six hours and 103 slowly over the 12 hours recommended by the World Health Organization.
RESULTS


All the children were successfully rehydrated. The admittance weights were similar for the slow and rapid groups: 8.4 kg and 8.3 kg. After 24 hours, the mean percentage weight gain was 8.5% and 9.0%, respectively. This confirmed that most of the children had been suffering from severe dehydration on admission. The respective proportions of children who received unscheduled intravenous fluid were 18% and 17%. None developed fluid overload or heart failure and most recovered normal renal function after rehydration.
CONCLUSION


Rapid rehydration saved time, was as safe as slow rehydration and was a better option for dehydrating diarrhoea and severe malnutrition.",2020,"CONCLUSION


Rapid rehydration saved time, was as safe as slow rehydration and was a better option for dehydrating diarrhoea and severe malnutrition.","['July 2011 to March 2014 at the International Centre for Diarrhoeal Disease Research Bangladesh', 'children aged 6-60\xa0months with dehydrating diarrhoea and severe malnutrition', 'children with weight for age and, or, weight for length Z-scores of less than -3 or with bipedal oedema and acute diarrhoea with severe dehydration', 'severely malnourished children with dehydrating diarrhoea']","['rapid and slow rehydration', 'rapid rehydration']","['admittance weights', 'mean percentage weight gain', 'fluid overload or heart failure', 'normal renal function']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1290807', 'cui_str': 'Diarrheal disorder'}, {'cui': 'C0035168'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0311276', 'cui_str': 'Severe malnutrition'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea (disorder)'}, {'cui': 'C3472181', 'cui_str': 'Severe dehydration'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0034997', 'cui_str': 'Rehydration'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0424660', 'cui_str': 'Percentage weight gain (observable entity)'}, {'cui': 'C0546817', 'cui_str': 'Hypervolemia (disorder)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0232805', 'cui_str': 'Normal renal function (finding)'}]",105.0,0.33823,"CONCLUSION


Rapid rehydration saved time, was as safe as slow rehydration and was a better option for dehydrating diarrhoea and severe malnutrition.","[{'ForeName': 'Nur H', 'Initials': 'NH', 'LastName': 'Alam', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Ashraf', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Tahmeed', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Nishat', 'Initials': 'N', 'LastName': 'Jahan', 'Affiliation': 'Department of Pharmacy, University of Asia Pacific, Dhaka, Bangladesh.'}, {'ForeName': 'Niklaus', 'Initials': 'N', 'LastName': 'Gyr', 'Affiliation': 'Faculty of Medicine, University of Basel, Basel, Switzerland.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15134']
1070,31826899,Pragmatic trial evaluating the effectiveness of a patient navigator to decrease emergency room utilisation in transition age youth with chronic conditions: the Transition Navigator Trial protocol.,"INTRODUCTION


Transition to adult care is a challenging and complex process for youth with special healthcare needs. We aim to compare effectiveness of a patient navigator service in reducing emergency room (ER) use among adolescents with chronic health conditions transitioning to adult care.
METHODS AND ANALYSIS


Pragmatic randomised controlled trial parallel group design comparing ER visit rates between patients with access to a personalised navigator intervention compared with usual care. Unit of randomisation is the patient. Treatment assignment will not be blinded. Embedded qualitative study to understand navigator's role and cost analysis attributable to the intervention will be performed. Patients aged 16-21 years, followed within a chronic disease clinic, expected to be transferred to adult care within 12 months and residing in Alberta during study period will be recruited from three tertiary care paediatric hospitals. Sample size will be 300 in each arm. Navigator intervention over 24 months is designed to assist participants in four domains: transition preparation, health system brokering, socioeconomic determinants of health and self-management. Primary outcome is ER visit rate during observation period. Secondary outcomes are ambulatory and inpatient care utilisation measures, as well as Transition Readiness Assessment Questionnaire score, and Short-Form Health Survey 12 (SF-12) score at 6 and 18 months post-randomisation. Poisson regression will compare rates of ER/urgent care visits between navigator and control participants, using intention to treat principle. Cost analysis of the intervention will be conducted. Thematic analysis will be used to identify perceptions of stakeholders regarding the role of navigators.
ETHICS AND DISSEMINATION


Ethics approval was obtained from the University of Calgary Conjoint Health Research Ethics Board (REB #162561) and the University of Alberta Health Research Ethics Board (Pro00077325). Our team is composed of diverse stakeholders who are committed to improving transition of care who will assist with dissemination of results.
TRIAL REGISTRATION NUMBER


NCT03342495.",2019,"Navigator intervention over 24 months is designed to assist participants in four domains: transition preparation, health system brokering, socioeconomic determinants of health and self-management.","['transition age youth with chronic conditions', 'adolescents with chronic health conditions transitioning to adult care', 'Patients aged 16-21 years, followed within a chronic disease clinic, expected to be transferred to adult care within 12 months and residing in Alberta during study period will be recruited from three tertiary care paediatric hospitals', 'patients with access to a']","['patient navigator to decrease emergency room utilisation', 'Navigator intervention', 'patient navigator service', 'personalised navigator intervention compared with usual care']","['ambulatory and inpatient care utilisation measures, as well as Transition Readiness Assessment Questionnaire score, and Short-Form Health Survey 12 (SF-12) score', 'ER visit rate during observation period']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3178922', 'cui_str': 'Transfer from Pediatric to Adult Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}]","[{'cui': 'C1709488', 'cui_str': 'Patient Navigators'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4720924', 'cui_str': 'Transition readiness assessment'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]",,0.186692,"Navigator intervention over 24 months is designed to assist participants in four domains: transition preparation, health system brokering, socioeconomic determinants of health and self-management.","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Samuel', 'Affiliation': 'Section of Nephrology, Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada susan.samuel@ahs.ca.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Dimitropoulos', 'Affiliation': 'Faculty of Social Work, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Kyleigh', 'Initials': 'K', 'LastName': 'Schraeder', 'Affiliation': ""Alberta Children's Hospital Research Institute, Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada.""}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Klarenbach', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Nettel-Aguirre', 'Affiliation': 'Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Guilcher', 'Affiliation': ""Section of Pediatric Oncology and Blood and Marrow Transplant, Alberta Children's Hospital, University of Calgary, Calgary, Alberta, Canada.""}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Pacaud', 'Affiliation': 'Section of Endocrinology, Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Pinzon', 'Affiliation': 'Section of Adolescent Medicine, Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Eddy', 'Initials': 'E', 'LastName': 'Lang', 'Affiliation': 'Department of Emergency Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Andrew', 'Affiliation': 'Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Lonnie', 'Initials': 'L', 'LastName': 'Zwaigenbaum', 'Affiliation': 'Department of Pediatrics, Autism Research Centre, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Scott', 'Affiliation': 'Faculty of Nursing, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'McBrien', 'Affiliation': 'Department of Family Medicine, Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Hamiwka', 'Affiliation': 'Section of Nephrology, Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Mackie', 'Affiliation': 'Division of Cardiology, Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada.'}]",BMJ open,['10.1136/bmjopen-2019-034309']
1071,31898191,The efficacy of mind-body (Baduanjin) exercise on self-reported sleep quality and quality of life in elderly subjects with sleep disturbances: a randomized controlled trial.,"OBJECTIVES


To examine the efficacy of a 24-week Baduanjin exercise program on self-reported sleep quality and quality of life in community-dwelling elderly subjects with sleep disturbances.
METHODS


Community-dwelling elderly men and women meeting criteria for sleep disturbances (i.e., Pittsburgh Sleep Quality of Index (PSQI) score ≥ 5) were recruited and randomized to a Baduanjin exercise intervention group or a control group. Participants in the intervention group completed five 45-min exercise sessions per week for 24 weeks, while those in control group were instructed to maintain their usual lifestyle behaviors.
RESULTS


A total of 139 participants were enrolled and randomized. Sixty-two of 67 participants in the intervention group (response rate of 92.5%) and 57 of 72 participants (response rate of 79.6%) in the control group completed intervention and follow-up. The intervention group reported significant improvements in overall sleep quality after 24 weeks compared with those randomized to control (PSQI endpoint-to-baseline change = - 2.6 ± 4.0 vs. - 0.5 ± 4.2, time × group interaction p = 0.007). Intervention group participants had higher response rates at both week 12 (23.9% vs. 9.7%, p = 0.025) and week 24 (40.3% vs. 15.3%, p = 0.001) when compared with the control group. There was a trend that the intervention group had increased quality of life (The Short Form Health Survey [SF-36] endpoint=tobaseline change 6.3 ± 10.9 vs. 2.2 ± 10.9, time × group interaction p = 0.06) when compared with the control group.
CONCLUSIONS


Baduanjin exercise is an effective and feasible approach to improve self-reported sleep quality but less likely the quality of life in community-dwelling elderly men and women with sleep disturbances.
TRIAL REGISTRATION


Effect of Baduanjin Exercise on the Elderly's Sleep; http://www.chictr.org.cn/listbycreater.aspx; ChiCTR1800014706, registered 1 January 2018.",2020,"The intervention group reported significant improvements in overall sleep quality after 24 weeks compared with those randomized to control (PSQI endpoint-to-baseline change = - 2.6 ± 4.0 vs. - 0.5 ± 4.2, time × group interaction p = 0.007).","['community-dwelling elderly subjects with sleep disturbances', 'elderly subjects with sleep disturbances', '139 participants were enrolled and randomized', 'Community-dwelling elderly men and women meeting criteria for sleep disturbances', ""Elderly's Sleep"", 'community-dwelling elderly men and women with sleep disturbances']","['45-min exercise sessions', 'Baduanjin exercise', 'Baduanjin exercise intervention group or a control group', 'Baduanjin exercise program', 'Baduanjin Exercise', 'mind-body (Baduanjin) exercise']","['response rates', 'quality of life', 'overall sleep quality', 'sleep quality and quality of life']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0524337', 'cui_str': 'Elderly man (person)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0034380'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",139.0,0.0584591,"The intervention group reported significant improvements in overall sleep quality after 24 weeks compared with those randomized to control (PSQI endpoint-to-baseline change = - 2.6 ± 4.0 vs. - 0.5 ± 4.2, time × group interaction p = 0.007).","[{'ForeName': 'Beifang', 'Initials': 'B', 'LastName': 'Fan', 'Affiliation': 'Department of Psychiatry, Shenzhen Nanshan Center for Chronic Disease Control, Nanshan, Shenzhen, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': 'Department of Psychiatry, Shenzhen Nanshan Center for Chronic Disease Control, Nanshan, Shenzhen, China. songweile@163.com.'}, {'ForeName': 'Jihui', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong SAR, China.'}, {'ForeName': 'Yuliang', 'Initials': 'Y', 'LastName': 'Er', 'Affiliation': 'The National Center for Chronic and Non-communicable Disease Control and Prevention, The Chinese Center for Disease Control and Prevention, Xicheng District, Beijing, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xie', 'Affiliation': 'Department of Psychiatry, Shenzhen Nanshan Center for Chronic Disease Control, Nanshan, Shenzhen, China.'}, {'ForeName': 'Huimin', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychiatry, Shenzhen Nanshan Center for Chronic Disease Control, Nanshan, Shenzhen, China.'}, {'ForeName': 'Yuhua', 'Initials': 'Y', 'LastName': 'Liao', 'Affiliation': 'Department of Psychiatry, Shenzhen Nanshan Center for Chronic Disease Control, Nanshan, Shenzhen, China.'}, {'ForeName': 'Chengmin', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Psychiatry, Shenzhen Nanshan Center for Chronic Disease Control, Nanshan, Shenzhen, China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Psychiatry, Shenzhen Nanshan Center for Chronic Disease Control, Nanshan, Shenzhen, China.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Mcintyre', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Yena', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, University of Toronto, Toronto, Canada.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-019-01999-w']
1072,31796495,"Evaluation of titanium mesh cranioplasty and polyetheretherketone cranioplasty: protocol for a multicentre, assessor-blinded, randomised controlled trial.","INTRODUCTION


Cranioplasty is a common surgery in neurosurgery department. However, restoring the integrity of skull brings many challenges to surgeons, and the selection of ideal implant materials is throughout the history of cranioplasty. Although titanium mesh was still preferred by many neurosurgeons in cranial reconstruction, the new polyetheretherketone (PEEK) material, for example, is gaining popularity for craniofacial reconstruction today. There remain limited data that compare the outcome of PEEK cranioplasty and titanium mesh cranioplasty. It is necessary to conduct a study to compare outcome of different materials for cranioplasty.
METHODS/DESIGN


In this multicentre, assessor-blinded, randomised controlled study, we will randomise 140 patients in a 1:1 ratio to PEEK cranioplasty versus titanium cranioplasty. Eligible patients are adults who were diagnosed with cranial defect (due to severe traumatic brain injury, ischaemic stroke, haemorrhagic stroke, infiltrative tumour and so on), the defect size is over 25 cm 2 , and they need to agree to participate in this trial. Instead of standard examinations, the enrolled patients receive neurological, motor, cognitive function and cerebral hemodynamics examinations as well as cosmetic evaluation. The procedures are repeated 3, 6 months after cranioplasty. The primary outcome, defined as infection or implant exposure after surgery, is the implant failure rate within 6 months. Secondary outcomes include postoperative complication rates, neurological outcomes, motor function, cerebral hemodynamics, cosmetic outcome and the total cost over a 6-month period.
ETHICS AND DISSEMINATION


This trial protocol has been approved by Biomedical Research Ethics Committee of West China Hospital of Sichuan University. All patients will be fully informed the implant materials, potential complications after surgery, responsibilities during the trial, and they will sign the informed consent before joining in this trial. If the patient's cognitive function is impaired, the patient's next of kin would be carefully informed. The results will be disseminated through academic conferences, student theses and will be published in a peer-reviewed journal.
TRAIL REGISTRATION NUMBER


ChiCTR1900024625; Pre-results.",2019,"Secondary outcomes include postoperative complication rates, neurological outcomes, motor function, cerebral hemodynamics, cosmetic outcome and the total cost over a 6-month period.
","['West China Hospital of Sichuan University', 'randomise 140 patients in a 1:1 ratio to PEEK cranioplasty versus titanium cranioplasty', 'Eligible patients are adults who were diagnosed with cranial defect (due to severe traumatic brain injury, ischaemic stroke, haemorrhagic stroke, infiltrative tumour and so on']","['titanium mesh', 'titanium mesh cranioplasty and polyetheretherketone cranioplasty']","['infection or implant exposure after surgery, is the implant failure rate', 'postoperative complication rates, neurological outcomes, motor function, cerebral hemodynamics, cosmetic outcome and the total cost over a 6-month period']","[{'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0084113', 'cui_str': 'polyetheretherketone'}, {'cui': 'C0196112', 'cui_str': 'Repair of bone of skull'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3163632', 'cui_str': 'Cranial'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0553692', 'cui_str': 'Haematencephalon'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]","[{'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0196112', 'cui_str': 'Repair of bone of skull'}, {'cui': 'C0084113', 'cui_str': 'polyetheretherketone'}]","[{'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0854676', 'cui_str': 'Failure of implant'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",140.0,0.175153,"Secondary outcomes include postoperative complication rates, neurological outcomes, motor function, cerebral hemodynamics, cosmetic outcome and the total cost over a 6-month period.
","[{'ForeName': 'Jingguo', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Neurosurgery, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Sun', 'Affiliation': 'Department of Neurosurgery, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Yikai', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Neurosurgery, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Xuepei', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Health Ministry Key Laboratory of Chronobiology, College of Basic Medicine and Forensic Medicine, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': ""Institute of Neurology, Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, Sichuan, China.""}, {'ForeName': 'Junwen', 'Initials': 'J', 'LastName': 'Guan', 'Affiliation': 'Department of Neurosurgery, West China Hospital, Sichuan University, Chengdu, Sichuan, China guanjunwen_scu@163.com.'}]",BMJ open,['10.1136/bmjopen-2019-033997']
1073,31793041,"Effects of MAL-PDT, ingenol mebutate and diclofenac plus hyaluronate gel monitored by high-frequency ultrasound and digital dermoscopy in actinic keratosis - a randomized trial.","BACKGROUND


The efficacy for actinic keratosis (AK) clearance of field-directed treatments has been investigated in randomized studies against placebo, but the comparison of results is difficult for several methodological reasons.
OBJECTIVES


The present study aims to compare efficacy of MAL-photodynamic therapy (MAL-PDT), ingenol mebutate gel (IMB) and diclofenac plus hyaluronate gel (DHA) on multiple AKs assessing a new performance index of efficacy, the cumulative AK area and evaluating dermoscopical and high-frequency ultrasound (HFUS) changes.
METHODS


Patients with ≥5 Olsen II AKs in a 25 cm 2  area of the scalp and face were enrolled and randomized to one of the treatment choices. Number of AKs and cumulative area were assessed before and after treatment. Dermoscopy and HFUS were performed on a single AK and surrounding photo-damaged skin in the treatment area.
RESULTS


Cumulative AKs area reduced significantly more with PDT compared to other treatment options and with IMB in comparison to DHA. PDT was also the only treatment option that increased at a significant level the dermal density in both target AK and the surrounding skin and decreased significantly the SLEB thickness in the perilesional skin at HFUS.
CONCLUSIONS


MAL-PDT is more effective than IMB and DHA for reducing the cumulative AK area which is calculated digitally from 3D pictures and should be the preferred performance index for the evaluation of the efficacy of treatments for AKs, rolling out clinical and dermoscopy evaluation. MAL-PDT improves all HFUS features of chronic photodamages of the dermis of the skin underlying and surrounding the AK spots.",2020,"PDT was also the only treatment option that increased at a significant level the dermal density in both target AK and the surrounding skin and decreased significantly the SLEB thickness in the perilesional skin at HFUS.
","['actinic keratosis ', 'patients with ≥ 5 Olsen II AKs in a 25 cm 2  area of the scalp and face']","['placebo', 'MAL-photodynamic therapy (MAL-PDT) , ingenol mebutate gel (IMB) and diclofenac plus hyaluronate gel (DHA', 'MAL-PDT, ingenol mebutate and diclofenac plus hyaluronate gel', 'MAL- PDT']","['cumulative AK area and evaluating dermoscopical and high frequency ultrasound (HFUS) changes', 'SLEB thickness', 'Number of AKs and cumulative area', 'PDT']","[{'cui': 'C0022602', 'cui_str': 'Senile keratoma (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0036270', 'cui_str': 'Scalp'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0031740', 'cui_str': 'Photodynamic Therapy'}, {'cui': 'C0044588', 'cui_str': 'PDT'}, {'cui': 'C2825682', 'cui_str': 'ingenol mebutate'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0178695', 'cui_str': 'hyaluronate'}]","[{'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0044588', 'cui_str': 'PDT'}]",,0.0428022,"PDT was also the only treatment option that increased at a significant level the dermal density in both target AK and the surrounding skin and decreased significantly the SLEB thickness in the perilesional skin at HFUS.
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Arisi', 'Affiliation': 'Department of Dermatology, ASST Spedali Civili di Brescia, University of Brescia, Brescia, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Zane', 'Affiliation': 'Department of Dermatology, ASST Spedali Civili di Brescia, University of Brescia, Brescia, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Polonioli', 'Affiliation': 'Department of Dermatology, ASST Spedali Civili di Brescia, University of Brescia, Brescia, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Tomasi', 'Affiliation': 'Department of Experimental and Applied Medicine, Section\xa0of Industrial Hygiene, ASST Spedali Civili di Brescia, University of Brescia, Brescia, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Moggio', 'Affiliation': 'Department of Dermatology, ASST Spedali Civili di Brescia, University of Brescia, Brescia, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cozzi', 'Affiliation': 'Department of Dermatology, ASST Spedali Civili di Brescia, University of Brescia, Brescia, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Soglia', 'Affiliation': 'Department of Dermatology, ASST Spedali Civili di Brescia, University of Brescia, Brescia, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Caravello', 'Affiliation': 'Department of Dermatology, ASST Spedali Civili di Brescia, University of Brescia, Brescia, Italy.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Calzavara-Pinton', 'Affiliation': 'Department of Dermatology, ASST Spedali Civili di Brescia, University of Brescia, Brescia, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Venturini', 'Affiliation': 'Department of Dermatology, ASST Spedali Civili di Brescia, University of Brescia, Brescia, Italy.'}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Rossi', 'Affiliation': 'Department of Dermatology, ASST Spedali Civili di Brescia, University of Brescia, Brescia, Italy.'}, {'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Calzavara-Pinton', 'Affiliation': 'Department of Dermatology, ASST Spedali Civili di Brescia, University of Brescia, Brescia, Italy.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16123']
1074,31483891,Young children with moderate-to-severe atopic dermatitis can be treated safely and effectively with either topical tacrolimus or mild corticosteroids.,"AIM


We collected evidence and safety data for topical tacrolimus in small children with atopic dermatitis (AD) and compared the usage with topical corticosteroid.
METHODS


This was an interim analysis of 75 patients (55% female) at 1 year of an ongoing 3-year randomised open-label comparative follow-up study of topical tacrolimus vs corticosteroid treatment. One- to three-year-old children with moderate-to-severe eczema referred to the Skin and Allergy Hospital in Helsinki, Finland, were enrolled.
RESULTS


Efficacy parameters, the Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), transepidermal water loss (TEWL), eczema area, serum total immunoglobulin E (IgE) and the blood eosinophil count, showed improvement in both groups during the study. However, patients with signs of early sensitisation at baseline (elevated serum total IgE, elevated eosinophil count, positive prick tests or specific IgEs to aero or food allergens) had statistically significantly lower TEWL at the eczema site and a smaller eczema area at 12 months in the tacrolimus group. No severe adverse effects were seen during the treatment.
CONCLUSION


Children with AD and signs of early sensitisation appeared to benefit more from early tacrolimus than corticosteroid treatment. Small children may need stronger but nevertheless safe ointment options when treating moderate-to-severe AD.",2020,"No severe adverse effects were seen during the treatment.
","['old children with moderate-to-severe eczema referred to the Skin and Allergy Hospital in Helsinki, Finland, were enrolled', '75 patients (55% female) at one year of an ongoing three-year randomized open-label comparative follow-up study of', 'Young children with moderate-to-severe atopic dermatitis', 'small children with atopic dermatitis (AD']","['topical tacrolimus vs. corticosteroid treatment', 'tacrolimus', 'topical tacrolimus', 'topical tacrolimus or mild corticosteroids']","[""Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), transepidermal water loss (TEWL), eczema area, serum total immunoglobulin E (IgE) and the blood eosinophil count"", 'severe adverse effects', 'serum total IgE, elevated eosinophil count, positive prick tests or specific IgEs to aero or food allergens']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0002111', 'cui_str': 'Allergy Specialty'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}]","[{'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0443626', 'cui_str': 'Total immunoglobulin level (finding)'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count - observation'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0430561', 'cui_str': 'Prick test (procedure)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1320239', 'cui_str': 'Food allergen'}]",75.0,0.0965968,"No severe adverse effects were seen during the treatment.
","[{'ForeName': 'Miia', 'Initials': 'M', 'LastName': 'Perälä', 'Affiliation': 'University of Helsinki and Helsinki University Hospital, Skin and Allergy Hospital, Helsinki, Finland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ahola', 'Affiliation': 'University of Helsinki and Helsinki University Hospital, Skin and Allergy Hospital, Helsinki, Finland.'}, {'ForeName': 'Tytti', 'Initials': 'T', 'LastName': 'Mikkola', 'Affiliation': 'University of Helsinki and Helsinki University Hospital, Skin and Allergy Hospital, Helsinki, Finland.'}, {'ForeName': 'Anna S', 'Initials': 'AS', 'LastName': 'Pelkonen', 'Affiliation': 'University of Helsinki and Helsinki University Hospital, Skin and Allergy Hospital, Helsinki, Finland.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Remitz', 'Affiliation': 'University of Helsinki and Helsinki University Hospital, Skin and Allergy Hospital, Helsinki, Finland.'}, {'ForeName': 'Mika J', 'Initials': 'MJ', 'LastName': 'Mäkelä', 'Affiliation': 'University of Helsinki and Helsinki University Hospital, Skin and Allergy Hospital, Helsinki, Finland.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15001']
1075,31918929,Randomized Comparison Between Everolimus-Eluting Bioresorbable Scaffold and Metallic Stent: Multimodality Imaging Through 3 Years.,"OBJECTIVES


The aim of this study was to investigate the vascular responses and fates of the scaffold after bioresorbable vascular scaffold (BVS) implantation using multimodality imaging.
BACKGROUND


Serial comprehensive image assessments after BVS implantation in the context of a randomized trial have not yet been reported.
METHODS


In the ABSORB Japan trial, 400 patients were randomized to a BVS (n = 266) or a cobalt-chromium everolimus-eluting stent (n = 134). Through 3 years, patients underwent serial angiography and intravascular ultrasound or optical coherence tomography (OCT).
RESULTS


Luminal dimension at 3 years was consistently smaller with the BVS than with the cobalt-chromium everolimus-eluting stent (mean angiographic minimal luminal diameter 2.04 ± 0.63 mm vs. 2.40 ± 0.56 mm, mean difference -0.37 mm [95% confidence interval: -0.50 to -0.24 mm]; p < 0.001), mainly because of smaller device area (6.13 ± 2.03 mm 2  vs. 7.15 ± 2.16 mm 2 , mean difference -1.04 mm 2  [95% confidence interval: -1.66 to -0.42 mm 2 ]; p < 0.001), and larger neointimal area (2.10 ± 0.61 mm 2  vs. 1.86 ± 0.64 mm 2 , mean difference 0.24 mm 2  [95% confidence interval: 0.06 to 0.43 mm 2 ]; p = 0.01) by OCT. BVS-treated vessels did not show previously reported favorable vessel responses, such as positive vessel remodeling, late luminal enlargement, and restoration of vasomotion, although the OCT-based healing score was on average zero (interquartile range: 0.00 to 0.00). At 3 years, intraluminal scaffold dismantling (ISD) was observed in 14% of BVS. On serial OCT, ISD was observed in 6 lesions at 2 years, where the struts had been fully apposed at post-procedure, while ISD was observed in 12 lesions at 3 years, where 8 lesions were free from ISD on 2-year OCT. In 5 cases of very late scaffold thrombosis, strut discontinuities were detected in all 4 cases with available OCT immediately before reintervention.
CONCLUSIONS


In this multimodality serial imaging study, luminal dimension at 3 years was smaller with the BVS than with the cobalt-chromium everolimus-eluting stent. ISD, suspected to be one of the mechanisms of very late BVS thrombosis, was observed in a substantial proportion of cases at 3 years, which developed between post-procedure and 2 years and even beyond 2 years. (AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 [Absorb™ BVS] in Japanese Population [ABSORB JAPAN]; NCT01844284).",2020,"p < 0.001), and larger neointimal area (2.10 ± 0.61 mm 2  vs. 1.86 ± 0.64 mm 2 , mean difference 0.24 mm 2  [95% confidence interval: 0.06 to 0.43 mm 2 ]; p = 0.01) by OCT.",['400 patients'],"['AVJ-301 [Absorb™ BVS', 'Everolimus-Eluting Bioresorbable Scaffold and Metallic Stent', 'BVS', 'cobalt-chromium everolimus-eluting stent', 'serial angiography and intravascular ultrasound or optical coherence tomography (OCT']","['positive vessel remodeling, late luminal enlargement, and restoration of vasomotion', 'OCT-based healing score', 'larger neointimal area', 'intraluminal scaffold dismantling (ISD', 'serial OCT, ISD']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0337143', 'cui_str': 'Scaffold, device (physical object)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0009148', 'cui_str': 'Cobalt'}, {'cui': 'C0168430', 'cui_str': 'chromium hexavalent ion'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0442123', 'cui_str': 'Intravascular (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C1293134', 'cui_str': 'Enlargement procedure'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0442115', 'cui_str': 'Intraluminal (qualifier value)'}, {'cui': 'C0337143', 'cui_str': 'Scaffold, device (physical object)'}]",400.0,0.121855,"p < 0.001), and larger neointimal area (2.10 ± 0.61 mm 2  vs. 1.86 ± 0.64 mm 2 , mean difference 0.24 mm 2  [95% confidence interval: 0.06 to 0.43 mm 2 ]; p = 0.01) by OCT.","[{'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Thoraxcenter, Erasmus MC, Rotterdam, the Netherlands; Cardialysis, Rotterdam, the Netherlands.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Honda', 'Affiliation': 'Stanford Cardiovascular Institute, Stanford, California.'}, {'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Asano', 'Affiliation': 'Cardialysis, Rotterdam, the Netherlands; Academic Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Shiomi', 'Affiliation': 'Kyoto University Hospital, Kyoto, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kozuma', 'Affiliation': 'Teikyo University Hospital, Tokyo, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Ozaki', 'Affiliation': 'Fujita Health University Hospital, Toyoake, Japan.'}, {'ForeName': 'Atsuo', 'Initials': 'A', 'LastName': 'Namiki', 'Affiliation': 'Kanto Rosai Hospital, Kawasaki, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Yasuda', 'Affiliation': 'National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Ueno', 'Affiliation': 'Kurume University School of Medicine, Kurume, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ando', 'Affiliation': 'Division of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan.'}, {'ForeName': 'Jungo', 'Initials': 'J', 'LastName': 'Furuya', 'Affiliation': 'Hanaoka Seishu Memorial Cardiovascular Clinic, Hokkaido, Japan.'}, {'ForeName': 'Keiichi Igarashi', 'Initials': 'KI', 'LastName': 'Hanaoka', 'Affiliation': 'Hanaoka Seishu Memorial Cardiovascular Clinic, Hokkaido, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Tanabe', 'Affiliation': 'Mitsui Memorial Hospital, Tokyo, Japan.'}, {'ForeName': 'Kozo', 'Initials': 'K', 'LastName': 'Okada', 'Affiliation': 'Stanford Cardiovascular Institute, Stanford, California.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Kitahara', 'Affiliation': 'Stanford Cardiovascular Institute, Stanford, California.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': 'Cardialysis, Rotterdam, the Netherlands; Academic Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Kusano', 'Affiliation': 'Abbott Vascular, Santa Clara, California.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Rapoza', 'Affiliation': 'Abbott Vascular, Santa Clara, California.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Simonton', 'Affiliation': 'Abbott Vascular, Santa Clara, California.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Popma', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Columbia University Medical Center, NewYork-Presbyterian Hospital, and the Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Fitzgerald', 'Affiliation': 'Stanford Cardiovascular Institute, Stanford, California.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Kyoto University Hospital, Kyoto, Japan. Electronic address: taketaka@kuhp.kyoto-u.ac.jp.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.09.047']
1076,31532835,No effect of a musical intervention on stress response to venepuncture in a neonatal population.,"AIM


To investigate the effect of a musical intervention on neonatal stress response to venepuncture as measured by salivary cortisol levels and pain profile scores.
METHODS


In a randomised control crossover trial, participants were randomised to both a control arm (sucrose) and intervention arm (sucrose and music) for routine venepuncture procedures. Salivary swabs were collected at baseline, 20 minutes post-venepuncture and 4 hours post-venepuncture. Pain levels were assessed using the Premature Infant Pain Profile (PIPP). A total of 16 preterm neonates participated in both arms to complete the study.
RESULTS


Cortisol values were elevated at all timepoints in the intervention arm (baseline, 20 minutes, and 4 hours post-procedure) but not significantly so (P = .056, P = .3, and P = .575, respectively). Median change in cortisol values from baseline was +128.48 pg/mL (-47.66 to 517.02) at 20 minutes and +393.52 pg/mL (47.88-1221.34) at 4 hours post-procedure in the control arm compared to -69.564 pg/mL (-860.96 to 397.289) and +100.48 pg/mL (-560.46 to 842.99) at 20 minutes and 4 hours post-procedure in the intervention arm. There was no statistically significant difference observed between groups (P = .311 at 20 minutes, and P = .203 at 4 hours post-procedure). PIPP scores were not significantly different between study arms.
CONCLUSION


Our findings did not support the additional benefit of music intervention on neonatal stress response to venepuncture in preterm infants.",2020,Our findings did not support the additional benefit of music intervention on neonatal stress response to venepuncture in preterm infants.,"['a neonatal population', '16 preterm neonates participated in both arms to complete the study', 'preterm infants']","['musical intervention', 'music intervention', 'control arm (sucrose) and intervention arm (sucrose and music']","['Cortisol values', 'stress response', 'salivary cortisol levels and pain profile scores', 'Pain levels', 'Median change in cortisol values', 'Premature Infant Pain Profile (PIPP', 'PIPP scores', 'neonatal stress response']","[{'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms (body structure)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}]","[{'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}]",,0.289871,Our findings did not support the additional benefit of music intervention on neonatal stress response to venepuncture in preterm infants.,"[{'ForeName': 'Caoimhe', 'Initials': 'C', 'LastName': 'Howard', 'Affiliation': 'Department of Paediatrics and Child Health, Neonatal Intensive Care Unit, Cork University Maternity Hospital, Cork, Ireland.'}, {'ForeName': 'Anna S', 'Initials': 'AS', 'LastName': 'Powell', 'Affiliation': 'Department of Paediatrics and Child Health, Neonatal Intensive Care Unit, Cork University Maternity Hospital, Cork, Ireland.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Pavlidis', 'Affiliation': 'INFANT, Irish Centre for Fetal and Neonatal Translational Research, University College Cork, Cork, Ireland.'}, {'ForeName': 'Andreea', 'Initials': 'A', 'LastName': 'Pavel', 'Affiliation': 'Department of Paediatrics and Child Health, Neonatal Intensive Care Unit, Cork University Maternity Hospital, Cork, Ireland.'}, {'ForeName': 'Daragh', 'Initials': 'D', 'LastName': 'Finn', 'Affiliation': 'INFANT, Irish Centre for Fetal and Neonatal Translational Research, University College Cork, Cork, Ireland.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Allen', 'Affiliation': 'APC Microbiome Ireland, Biosciences Institute, University College Cork, Cork, Ireland.'}, {'ForeName': 'Loreto', 'Initials': 'L', 'LastName': 'Olavarria-Ramirez', 'Affiliation': 'APC Microbiome Ireland, Biosciences Institute, University College Cork, Cork, Ireland.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Clarke', 'Affiliation': 'INFANT, Irish Centre for Fetal and Neonatal Translational Research, University College Cork, Cork, Ireland.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Livingstone', 'Affiliation': 'INFANT, Irish Centre for Fetal and Neonatal Translational Research, University College Cork, Cork, Ireland.'}, {'ForeName': 'Geraldine B', 'Initials': 'GB', 'LastName': 'Boylan', 'Affiliation': 'Department of Paediatrics and Child Health, Neonatal Intensive Care Unit, Cork University Maternity Hospital, Cork, Ireland.'}, {'ForeName': 'Eugene M', 'Initials': 'EM', 'LastName': 'Dempsey', 'Affiliation': 'Department of Paediatrics and Child Health, Neonatal Intensive Care Unit, Cork University Maternity Hospital, Cork, Ireland.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15018']
1077,31577041,Short-term effects of hyaluronic acid on the subgingival microbiome in peri-implantitis: A randomized controlled clinical trial.,"BACKGROUND


The aim of our study was to evaluate the effects of a hyaluronic acid (HA) gel at 45 days on the microbiome of implants with peri-implantitis with at least 1 year of loading.
METHODS


A randomized controlled trial was conducted in peri-implantitis patients. Swabs containing the samples were collected both at baseline and after 45 days of treatment. 16S rRNA sequencing techniques were used to investigate the effect of HA gel on the subgingival microbiome.
RESULTS


One hundred and eight samples of 54 patients were analyzed at baseline and after follow-up at 45 days. Three strata with different microbial composition were obtained in the samples at baseline, representing three main microbial consortia associated with peri-implantitis. Stratum 1 did not show any difference for any variable after treatment with HA, whereas in stratum 2, Streptococcus, Veillonella, Rothia, and Granulicatella did decrease (P < 0.05). Similarly, Prevotella and Campylobacter (P < 0.05) decreased in stratum 3 after treatment with HA. Microbial diversity was found to be decreased in stratum 3 (P < 0.05) after treatment with HA compared with the control group, in which an increase was found (P < 0.05).
CONCLUSIONS


HA reduced the relative abundance of peri-implantitis-related microorganisms, especially the early colonizing bacteria, suggesting a specific action during the first stages in the development of the disease. HA did not alter relative abundances of non-oral genera. The use of HA in advanced stages of peri-implantitis resulted in a decrease in microbial alpha diversity, suggesting a protective action of the peri-implant site against bacteria colonization.",2020,"The use of hyaluronic acid in advanced stages of peri-implantitis resulted in a decrease in microbial alpha diversity, suggesting a protective action of the peri-implant site against bacteria colonization.","['implants with peri-implantitis with at least one year of loading', 'peri-implantitis patients', 'peri-implantitis', '108 samples of 54 patients']","['hyaluronic acid', 'hyaluronic acid gel', 'Hyaluronic acid']","['microbial alpha diversity', 'Microbial diversity', 'relative abundances of non-oral genera']","[{'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C2936258', 'cui_str': 'Periimplantitis'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]",,0.129597,"The use of hyaluronic acid in advanced stages of peri-implantitis resulted in a decrease in microbial alpha diversity, suggesting a protective action of the peri-implant site against bacteria colonization.","[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Soriano-Lerma', 'Affiliation': 'Department of Physiology (Faculty of Pharmacy, Campus Universitario de Cartuja), Institute of Nutrition and Food Technology ""José Mataix"", University of Granada, Granada, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Magán-Fernández', 'Affiliation': 'Department of Periodontics, School of Dentistry, University of Granada, Granada, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Gijón', 'Affiliation': 'Department of Periodontics, School of Dentistry, University of Granada, Granada, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Sánchez-Fernández', 'Affiliation': 'Department of Oral Surgery and Implant Dentistry, School of Dentistry, University of Granada, Granada, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Soriano', 'Affiliation': 'GENYO, Centre for Genomics and Oncological Research: Pfizer/University of Granada/Andalusian Regional Government, PTS Granada, Granada, Spain.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'García-Salcedo', 'Affiliation': 'Microbiology Unit, Biosanitary Research Institute ibs.GRANADA, University Hospital Virgen de las Nieves, Granada, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Mesa', 'Affiliation': 'Department of Periodontics, School of Dentistry, University of Granada, Granada, Spain.'}]",Journal of periodontology,['10.1002/JPER.19-0184']
1078,31778021,Randomized controlled double-blind study of a cleanser composed of 5-aminolevulinic acid and peptides on mild and moderate acne vulgaris.,"BACKGROUND


Existing treatments of acne vulgaris may be complicated or elicit undesirable side effects. Therefore, new and safe therapeutic modalities are needed.
OBJECTIVES


We investigated the effects of a cleanser with 5-aminolevulinic acid and peptides on mild to moderate acne vulgaris.
METHODS


Sixty volunteers with mild to moderate acne vulgaris (IGA grade II-III) were randomly assigned to treatment or control groups of thirty respectively. Participants cleansed their faces twice a day for 8 weeks with either a cleanser with 5-aminolevulinic acid and peptides (treatment) or with basic cleanser (control). The number of acne lesions (comedones, papules, pustules, and nodules), Michaelson's acne severity, and IGA were measured every 2 weeks and patient satisfaction and adverse events at week 8.
RESULTS


Mean number of inflammatory acne lesions in treatment group decreased from 5.9 at baseline to 4.5 at week 4 and 4.1 at week 8 (in particular, P < .05). The mean number of noninflammatory lesions in treatment group decreased from 11.4 at baseline to 8.8 at week 4 and 7.4 at week 8 (in particular, P < .05). The mean value of Michaelson's acne severity index and IGA in treatment group also decreased from baseline to week 4 and week 8 (both in particular, P < .05). Investigator's assessment and patient satisfaction in treatment group at week 8 were better than control group. Adverse events in two groups were similar.
CONCLUSIONS


We think the cleanser with 5-aminolevulinic acid and peptides is a useful and safe therapeutic agent for mild to moderate acne vulgaris.",2020,"The mean number of noninflammatory lesions in treatment group decreased from 11.4 at baseline to 8.8 at week 4 and 7.4 at week 8 (in particular, P ","['mild to moderate acne vulgaris', 'mild and moderate acne vulgaris', 'Sixty volunteers with mild to moderate acne vulgaris (IGA grade II-III']","['5-aminolevulinic acid and peptides', 'cleanser', 'cleanser with 5-aminolevulinic acid and peptides (treatment) or with basic cleanser (control', 'cleanser with 5-aminolevulinic acid and peptides']","[""Investigator's assessment and patient satisfaction"", ""mean value of Michaelson's acne severity index and IGA"", 'Adverse events', ""number of acne lesions (comedones, papules, pustules, and nodules), Michaelson's acne severity, and IGA"", 'mean number of noninflammatory lesions', 'Mean number of inflammatory acne lesions']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0001144', 'cui_str': 'Acne Vulgaris'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0002563', 'cui_str': 'Aminolevulinic Acid'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0221228', 'cui_str': 'Comedone (disorder)'}, {'cui': 'C0332563', 'cui_str': 'Papule (morphologic abnormality)'}, {'cui': 'C0442743', 'cui_str': 'Noninflammatory (qualifier value)'}, {'cui': 'C1998083', 'cui_str': 'Inflammatory acne'}]",60.0,0.0232803,"The mean number of noninflammatory lesions in treatment group decreased from 11.4 at baseline to 8.8 at week 4 and 7.4 at week 8 (in particular, P ","[{'ForeName': 'Hyun Ji', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Daegu, Korea.'}, {'ForeName': 'Jun Young', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Daegu, Korea.'}, {'ForeName': 'Kyung Duck', 'Initials': 'KD', 'LastName': 'Park', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Daegu, Korea.'}, {'ForeName': 'Weon Ju', 'Initials': 'WJ', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Daegu, Korea.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13232']
1079,31906882,Nomogram for predicting the survival of gastric adenocarcinoma patients who receive surgery and chemotherapy.,"BACKGROUND


Surgery is the only way to cure gastric adenocarcinoma (GAC), and chemotherapy is the basic adjuvant management for GAC. A significant prognostic nomogram for predicting the respective disease-specific survival (DSS) rates of GAC patients who receive surgery and chemotherapy has not been established.
OBJECTIVE


We were planning to establish a survival nomogram model for GAC patients who receive surgery and chemotherapy.
METHODS


We identified 5764 GAC patients who had received surgery and chemotherapy from the record of Surveillance, Epidemiology, and End Results (SEER) database. About 70% (n = 4034) of the chosen GAC patients were randomly assigned to the training set, and the rest of the included ones (n = 1729) were assigned to the external validation set. A prognostic nomogram was constructed by the training set and the predictive accuracy of it was validated by the validation set.
RESULTS


Based on the outcome of a multivariate analysis of candidate factors, a nomogram was developed that encompassed age at diagnosis, number of regional lymph nodes examined after surgery, number of positive regional lymph nodes, sex, race, grade, derived AJCC stage, summary stage, and radiotherapy status. The C-index (Harrell's concordance index) of the nomogram model was some larger than that of the traditional seventh AJCC staging system (0.707 vs 0.661). Calibration plots of the constructed nomogram displayed that the probability of DSS commendably accord with the survival rate. Integrated discrimination improvement (IDI) revealed obvious increase and categorical net reclassification improvement (NRI) showed visible enhancement. IDI for 3-, 5- and 10- year DSS were 0.058, 0.059 and 0.058, respectively (P > 0.05), and NRI for 3-, 5- and 10- year DSS were 0.380 (95% CI = 0.316-0.470), 0.407 (95% CI = 0.350-0.505), and 0.413 (95% CI = 0.336-0.519), respectively. Decision curve analysis (DCA) proved that the constructed nomogram was preferable to the AJCC staging system.
CONCLUSION


The constructed nomogram supplies more credible DSS predictions for GAC patients who receive surgery and chemotherapy in the general population. According to validation, the new nomogram will be beneficial in facilitating individualized survival predictions and useful when performing clinical decision-making for GAC patients who receive surgery and chemotherapy.",2020,The C-index (Harrell's concordance index) of the nomogram model was some larger than that of the traditional seventh AJCC staging system (0.707 vs 0.661).,"['5764 GAC patients who had received surgery and chemotherapy from the record of Surveillance, Epidemiology, and End Results (SEER) database', 'GAC patients who receive surgery and chemotherapy', 'About 70% (n\u2009=\u20094034) of the chosen GAC patients', 'gastric adenocarcinoma patients who receive surgery and chemotherapy', 'GAC patients who receive surgery and chemotherapy in the general population']",[],['survival rate'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C2355580', 'cui_str': 'Record of (contextual qualifier) (qualifier value)'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",[],"[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.0609674,The C-index (Harrell's concordance index) of the nomogram model was some larger than that of the traditional seventh AJCC staging system (0.707 vs 0.661).,"[{'ForeName': 'Chao-Yang', 'Initials': 'CY', 'LastName': 'Wang', 'Affiliation': 'Department of General Surgery, Huaihe Hospital of Henan University, Kaifeng, Henan, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Clinical Research Center, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zi', 'Affiliation': 'Institute of Evidence-Based Medicine and knowledge translation, Henan University, Kaifeng, Henan, China.'}, {'ForeName': 'Zhong-Li', 'Initials': 'ZL', 'LastName': 'Zheng', 'Affiliation': 'Institute of Evidence-Based Medicine and knowledge translation, Henan University, Kaifeng, Henan, China.'}, {'ForeName': 'Bing-Hui', 'Initials': 'BH', 'LastName': 'Li', 'Affiliation': 'Department of General Surgery, Huaihe Hospital of Henan University, Kaifeng, Henan, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of General Surgery, Huaihe Hospital of Henan University, Kaifeng, Henan, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Ge', 'Affiliation': 'Department of General Surgery, Huaihe Hospital of Henan University, Kaifeng, Henan, China.'}, {'ForeName': 'Guang-Xu', 'Initials': 'GX', 'LastName': 'Jian', 'Affiliation': 'Institute of Evidence-Based Medicine and knowledge translation, Henan University, Kaifeng, Henan, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Lyu', 'Affiliation': ""Clinical Research Center, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Xiao-Dong', 'Initials': 'XD', 'LastName': 'Li', 'Affiliation': 'Institute of Evidence-Based Medicine and knowledge translation, Henan University, Kaifeng, Henan, China.'}, {'ForeName': 'Xue-Qun', 'Initials': 'XQ', 'LastName': 'Ren', 'Affiliation': 'Department of General Surgery, Huaihe Hospital of Henan University, Kaifeng, Henan, China. renxuequn001@163.com.'}]",BMC cancer,['10.1186/s12885-019-6495-2']
1080,30073859,"The impact of a school-based musical contact intervention on prosocial attitudes, emotions and behaviours: A pilot trial with autistic and neurotypical children.","Children with autism are more likely to be socially excluded than their neurotypical peers. Since the majority of children with autism attend mainstream schools, interventions are needed to improve the attitudes and behaviours of their peers. Many studies highlight the influence of contact on positive attitudes and reduced discrimination. Group music-making provides an ideal opportunity for positive contact to occur in the classroom. This study evaluated the impact of music-based contact with autistic peers on the attitudes, emotions and behaviours of neurotypical children. Changes in those with autism were also assessed. Neurotypical participants ( n = 55) aged 10-11 years took part in an 11-week music programme designed to increase social interaction, which either did or did not include contact with autistic children ( n = 10). Measures of attitudes, emotions and behaviours were assessed at baseline and follow-up. In response to a hypothetical scenario depicting social exclusion of a child with autism, neurotypical participants in the contact group showed a greater increase in prosocial emotions and a greater decrease in tendency to be a victim than those in the no-contact group. Participants with autism also showed a 19.7% decrease in victimisation. Implications of group music-making for tackling social exclusion of children with autism are discussed.",2019,Participants with autism also showed a 19.7% decrease in victimisation.,"['Children with autism', 'Participants with autism', 'neurotypical children', 'children with autism', 'autistic and neurotypical children', 'Neurotypical participants ( n\u2009=\u200955) aged 10-11\u2009years took part in an 11-week', 'with autistic children ( n\u2009=\u200910']","['music programme designed to increase social interaction, which either did or did not include contact', 'music-based contact with autistic peers', 'school-based musical contact intervention']","['prosocial attitudes, emotions and behaviours', 'attitudes, emotions and behaviours', 'tendency to be a victim', 'victimisation', 'prosocial emotions']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0037420', 'cui_str': 'Social Interaction'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332158', 'cui_str': 'Contact with (contextual qualifier) (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C1292718', 'cui_str': 'Is a'}]",55.0,0.0232846,Participants with autism also showed a 19.7% decrease in victimisation.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Cook', 'Affiliation': 'University of Surrey, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Ogden', 'Affiliation': 'University of Surrey, UK.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Winstone', 'Affiliation': 'University of Surrey, UK.'}]",Autism : the international journal of research and practice,['10.1177/1362361318787793']
1081,31878810,Efficacy of Recombinant Human Epidermal Growth Factor (Regen-D 150) in Healing Diabetic Foot Ulcers: A Hospital-Based Randomized Controlled Trial.,"To validate the efficacy of recombinant human epidermal growth factor (hEGH) in healing diabetic foot ulcers (DFUs) at biochemical and molecular levels. A total of 50 noninfected DFU subjects were recruited for the study and divided into 2 groups based on the treatment application on the subjects. Group 1: DFU subjects treated with hEGH gel-based product called Regen-D 150 (n = 27) and group 2: DFU subjects treated with alternative placebo as the control group (n = 23). Patients were observed for 30 days and punch biopsy was taken at days 0 and 14. Histologic analysis was done to study the matrix alignment, cellular infiltration, and differentiation of epithelial layers. Biochemical analysis was done to quantitatively estimate the amount of collagen and proteoglycans regenerated in the wound area. Complete healing of ulcers was observed in 21 (78%) subjects in group 1, whereas only 12 (52%) subjects among group 2 reported of complete healing of ulcer after completion of the study period of 30 days. Collagen and fibroblasts were significantly developed in group 1 when observed in the follow-up samples. Healing time of the wound among the group 1 subjects was significantly less than the group 2 subjects (45 ± 12 vs 72 ± 18 days,  P  < .0001) and even showed a better blood glucose level. Early and regular application of the hEGH on DFUs will lead to prevention of leg amputations and would serve to act as a major treatment therapy for healing of chronic wounds.",2020,Collagen and fibroblasts were significantly developed in group 1 when observed in the follow-up samples.,"['Healing Diabetic Foot Ulcers', 'healing diabetic foot ulcers (DFUs', '50 noninfected DFU subjects']","['hEGH gel-based product called Regen-D 150', 'Recombinant Human Epidermal Growth Factor (Regen-D 150', 'recombinant human epidermal growth factor (hEGH', 'hEGH', 'DFU subjects treated with alternative placebo']","['blood glucose level', 'complete healing of ulcer', 'Healing time', 'Collagen and fibroblasts', 'Complete healing of ulcers']","[{'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer (disorder)'}]","[{'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1509244', 'cui_str': 'nepidermin'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0016030', 'cui_str': 'Fibroblasts'}]",,0.0185808,Collagen and fibroblasts were significantly developed in group 1 when observed in the follow-up samples.,"[{'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Viswanathan', 'Affiliation': 'MV Hospital for Diabetes and Prof. M. Viswanathan Diabetes Research Centre, WHO Collaborating Centre for Research, Education and Training in Diabetes & IDF Centre for Excellence in Diabetes Care, Chennai, India.'}, {'ForeName': 'Udyama', 'Initials': 'U', 'LastName': 'Juttada', 'Affiliation': 'MV Hospital for Diabetes and Prof. M. Viswanathan Diabetes Research Centre, WHO Collaborating Centre for Research, Education and Training in Diabetes & IDF Centre for Excellence in Diabetes Care, Chennai, India.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Babu', 'Affiliation': 'Central Leather Research Institute (CLRI), Chennai, India.'}]",The international journal of lower extremity wounds,['10.1177/1534734619892791']
1082,30626911,"A phase 2, double-blind, placebo-controlled study of NSI-189 phosphate, a neurogenic compound, among outpatients with major depressive disorder.","NSI-189 is a novel neurogenic compound independent of monoamine reuptake pathways. This trial evaluated oral NSI-189 as monotherapy in major depressive disorder. To improve signal detection, the sequential-parallel comparison design (SPCD) was chosen. Two hundred and twenty subjects were randomized to NSI-189 40 mg daily, 80 mg daily, or placebo for 12 weeks. The primary outcome measure was the Montogmery Asberg Depression Rating Scale (MADRS). Secondary subject-rated measures included the Symptoms of Depression Questionnaire (SDQ), the Cognitive and Physical Functioning Scale (CPFQ), the patient-rated version of the Quick Inventory of Depressive Symptomatology Scale (QIDS-SR), and subtests from the CogScreen and Cogstate cognitive tests. MADRS score reduction versus placebo did not reach significance for either dose (40 mg pooled mean difference -1.8, p = 0.22, 80 mg pooled mean difference -1.4, p = 0.34, respectively). However, the 40 mg dose showed greater overall reduction in SDQ (pooled mean difference -8.2; Cohen's d for Stages 1 and 2 = -0.11 and -0.64, p = 0.04), and CPFQ scores (pooled mean difference -1.9; Cohen's d for Stages 1 and 2 = -0.28 and -0.47, p = 0.03) versus placebo, as well as QIDS-SR scores in Stage 2 of SPCD (-2.5; Cohen's d Stages 1 and 2 = -0.03 and -0.68, p = 0.04). The 40 mg dose also showed advantages on some objective cognitive measures of the CogScreen (absolute Cohen's d ranged between 0.12 and 1.12 in favor of NSI-189, p values between 0.002 and 0.048 for those with overall significance), but not the Cogstate test. Both doses were well tolerated. These findings replicate those of phase 1b study, and warrant further exploration of the antidepressant and pro-cognitive effects of NSI-189.",2020,"MADRS score reduction versus placebo did not reach significance for either dose (40 mg pooled mean difference -1.8, p = 0.22, 80 mg pooled mean difference -1.4, p = 0.34, respectively).","['major depressive disorder', 'Two hundred and twenty subjects were randomized to NSI-189 40', 'outpatients with major depressive disorder']","['NSI-189 phosphate', 'NSI-189', 'placebo']","['Montogmery Asberg Depression Rating Scale (MADRS', 'MADRS score reduction', 'Symptoms of Depression Questionnaire (SDQ), the Cognitive and Physical Functioning Scale (CPFQ), the patient-rated version of the Quick Inventory of Depressive Symptomatology Scale (QIDS-SR), and subtests from the CogScreen and Cogstate cognitive tests', 'QIDS-SR scores', 'tolerated', 'overall reduction in SDQ', 'objective cognitive measures of the CogScreen', 'CPFQ scores']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C4507670', 'cui_str': 'NSI-189'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C4507671', 'cui_str': 'NSI-189 phosphate'}, {'cui': 'C4507670', 'cui_str': 'NSI-189'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology (assessment scale)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",220.0,0.16936,"MADRS score reduction versus placebo did not reach significance for either dose (40 mg pooled mean difference -1.8, p = 0.22, 80 mg pooled mean difference -1.4, p = 0.34, respectively).","[{'ForeName': 'G I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA. gpapakostas@partners.org.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Johe', 'Affiliation': 'Neuralstem, Inc, Germantown, MD, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hand', 'Affiliation': 'Neuralstem, Inc, Germantown, MD, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Drouillard', 'Affiliation': 'Neuralstem, Inc, Germantown, MD, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Russo', 'Affiliation': 'Neuralstem, Inc, Germantown, MD, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Kay', 'Affiliation': 'Cognitive Research Corp., Saint Petersburg, Florida, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kashambwa', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hoeppner', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Flynn', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Yeung', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Martinson', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}]",Molecular psychiatry,['10.1038/s41380-018-0334-8']
1083,31867656,Marketing Influences on Perceptions of Reduced Nicotine Content Cigarettes.,"INTRODUCTION


The Food and Drug Administration announced intent to reduce the nicotine content in cigarettes. There is limited evidence on how reduced nicotine content cigarette (RNC) marketing affects product beliefs and use, and research on this is needed to inform regulations.
METHODS


In an online experiment, 426 young adult cigarette smokers (aged 18-30 years) were randomized in a 2 (implicit: red package vs. blue package) × 2 (explicit: corrective message vs. no corrective message) design to view an advertisement for previously commercially available RNCs. Outcomes were advertisement content recall, product beliefs, and use intentions. Participants' responses to open-ended assessment of their beliefs about the stimuli were coded to identify prevailing themes.
RESULTS


Red packaging and corrective messaging were independently associated with greater advertisement content recall (p = .01 and p = .04, respectively). There were no significant main or interaction effects on product beliefs or use intentions. Controlling for condition, advertisement content recall was significantly associated with less favorable product beliefs (p < .001) and favorable product beliefs were associated with intent to use the product (p < .001). Open-ended responses converged on the finding that respondents were interested in RNCs, but expressed skepticism about effectiveness and value.
CONCLUSIONS


Brief exposure to an RNC advertisement with red packaging and corrective messaging were each independently associated with greater advertisement content recall. The results indicate: (1) interest and confusion among young adult smokers regarding RNCs, (2) beliefs about RNCs are influenced by marketing, and (3) beliefs are associated with intention to use RNCs.
IMPLICATIONS


Findings from this study demonstrate the importance of advertising effects on beliefs about RNC products and support the need to regulate advertising and labeling alongside product regulation. More detailed study of advertisement features that affect consumers' beliefs about RNCs and how they impact their processing of explicit messaging about product risks will be important to guide regulatory decision-making.",2019,"Red packaging and corrective messaging were independently associated with greater advertisement content recall (p = .01 and p = .04, respectively).","['cigarettes', '426 young adult cigarette smokers (aged 18-30 years']","['× 2 (explicit: corrective message vs. no corrective message) design to view an advertisement for previously commercially available RNCs', '2 (implicit: red package vs. blue package']","['favorable product beliefs', 'product beliefs or use intentions', 'advertisement content recall, product beliefs, and use intentions', 'Red packaging and corrective messaging', 'advertisement content recall']","[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C1260957', 'cui_str': 'Blue color (qualifier value)'}]","[{'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0030176', 'cui_str': 'Packaging'}]",426.0,0.0295965,"Red packaging and corrective messaging were independently associated with greater advertisement content recall (p = .01 and p = .04, respectively).","[{'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Johnson', 'Affiliation': 'Milken Institute School of Public Health, George Washington University, Washington, DC.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Mays', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Villanti', 'Affiliation': 'Vermont Center on Behavior and Health, Department of Psychiatry, University of Vermont Larner College of Medicine, Burlington, VT.'}, {'ForeName': 'Raymond S', 'Initials': 'RS', 'LastName': 'Niaura', 'Affiliation': 'New York University College of Global Public Health, New York, NY.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Rehberg', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'Lilianna', 'Initials': 'L', 'LastName': 'Phan', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Mercincavage', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Luta', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Strasser', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz167']
1084,30284172,Quality Improvement and Personalization for Statins: the QUIPS Quality Improvement Randomized Trial of Veterans' Primary Care Statin Use.,"BACKGROUND


Implementation of new practice guidelines for statin use was very poor.
OBJECTIVE


To test a multi-component quality improvement intervention to encourage use of new guidelines for statin use.
DESIGN


Cluster-randomized, usual-care controlled trial.
PARTICIPANTS


The study population was primary care visits for patients who were recommended statins by the 2013 guidelines, but were not receiving them. We excluded patients who were over 75 years old, or had an ICD9 or ICD10 code for end-stage renal disease, muscle pain, pregnancy, or in vitro fertilization in the 2 years prior to the study visit.
INTERVENTIONS


A novel quality improvement intervention consisting of a personalized decision support tool, an educational program, a performance measure, and an audit and feedback system. Randomization was at the level of the primary care team.
MAIN MEASURES


Our primary outcome was prescription of a medium- or high-strength statin. We studied how receiving the intervention changed care during the quality improvement intervention compared to before it and if that change continued after the intervention.
KEY RESULTS


Among 3787 visits to 43 primary care providers, being in the intervention arm tripled the odds of patients being prescribed an appropriate statin (OR 3.0, 95% CI 1.8-4.9), though the effect resolved after the personalized decision support ended (OR 1.7, 95% CI 0.99-2.77).
CONCLUSIONS


A simple, personalized quality improvement intervention is promising for enabling the adoption of new guidelines. CLINICALTRIALS.
GOV IDENTIFIER


NCT02820870.",2018,"Among 3787 visits to 43 primary care providers, being in the intervention arm tripled the odds of patients being prescribed an appropriate statin (OR","['3787 visits to 43 primary care providers, being in the intervention arm tripled the odds of patients being prescribed an appropriate statin (OR', 'patients who were over 75\xa0years old, or had an ICD9 or ICD10 code for end-stage renal disease, muscle pain, pregnancy, or in vitro fertilization in the 2\xa0years prior to the study visit', 'study population was primary care visits for patients who were recommended statins by the 2013 guidelines, but were not receiving them']",[],['prescription of a medium- or high-strength statin'],"[{'cui': 'C2735026', 'cui_str': 'Primary care provider (occupation)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for (contextual qualifier) (qualifier value)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}]",[],"[{'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0360714', 'cui_str': 'Statins'}]",,0.0726974,"Among 3787 visits to 43 primary care providers, being in the intervention arm tripled the odds of patients being prescribed an appropriate statin (OR","[{'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'B Sussman', 'Affiliation': 'University of Michigan Department of Internal Medicine, Ann Arbor, MI, USA. jeremysu@med.umich.edu.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Holleman', 'Affiliation': 'VA Center for Clinical Management Research, Ann Arbor, MI, USA.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Youles', 'Affiliation': 'VA Center for Clinical Management Research, Ann Arbor, MI, USA.'}, {'ForeName': 'Julie C', 'Initials': 'JC', 'LastName': 'Lowery', 'Affiliation': 'VA Center for Clinical Management Research, Ann Arbor, MI, USA.'}]",Journal of general internal medicine,['10.1007/s11606-018-4681-6']
1085,31880796,Comparison of Lemborexant With Placebo and Zolpidem Tartrate Extended Release for the Treatment of Older Adults With Insomnia Disorder: A Phase 3 Randomized Clinical Trial.,"Importance


Insomnia disorder is prevalent and associated with health risks in older adults; however, efficacy and safety issues with existing treatments create significant unmet needs in this patient population.
Objective


To compare treatment with the orexin receptor antagonist lemborexant with placebo and zolpidem tartrate extended release in participants with insomnia disorder.
Design, Setting, and Participants


The Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1) clinical trial was a global randomized double-blind parallel-group placebo-controlled active-comparator phase 3 study conducted at 67 sites in North America and Europe from May 31, 2016, to January 30, 2018. Data analyses were conducted from January 31, 2018, to September 10, 2018. Participants were 55 years and older with insomnia disorder characterized by reported sleep maintenance difficulties and confirmed by sleep history, sleep diary, and polysomnography. Participants could have also had sleep onset difficulties.
Interventions


Participants received placebo, zolpidem tartrate extended release (6.25 mg), or lemborexant (5 mg or 10 mg) for 1 month at bedtime.
Main Outcomes and Measures


Paired polysomnograms were collected at baseline, the first 2 nights, and the last 2 nights of treatment. The primary end point was the change from baseline in latency to persistent sleep for lemborexant therapy vs placebo. Key secondary end points were changes from baseline in sleep efficiency and wake-after-sleep onset compared with placebo, and wake-after-sleep onset in the second half of the night compared with zolpidem therapy.
Results


Among 1006 participants randomized (placebo, n = 208; zolpidem, n = 263; lemborexant 5 mg, n = 266; and lemborexant 10 mg, n = 269), 869 (86.4%) were women and the median age was 63 years (range, 55-88 years). Both doses of lemborexant therapy demonstrated statistically significant greater changes from baseline on objective sleep onset as assessed by latency to persistent sleep (log transformed) that was measured using polysomnography at the end of 1 month of treatment (nights 29 and 30) compared with placebo (primary end point for least squares geometric means treatment ratio vs placebo: for lemborexant 5 mg, 0.77; 95% CI, 0.67-0.89; P < .001; for lemborexant 10 mg, 0.72; 95% CI, 0.63-0.83; P < .001). For nights 29 and 30, as measured using polysomnography, the mean change from baseline in sleep efficiency (LSM treatment difference vs placebo for lemborexant 5 mg, 7.1%; 95% CI, 5.6%-8.5%; P < .001 and for lemborexant 10 mg, 8.0%; 95% CI, 6.6%-9.5%; P < .001) and wake-after-sleep onset (least squares mean treatment ratio vs placebo for lemborexant 5 mg, -24.0 min; 95% CI, -30.0 to -18.0 min; P < .001 and for lemborexant 10 mg, -25.4 min; 95% CI, -31.4 to -19.3 min; P < .001) were significantly greater for both doses of lemborexant therapy compared with placebo. Also, for nights 29 and 30, wake-after-sleep onset in the second half of the night (least squares mean treatment difference vs zolpidem for lemborexant 5 mg, -6.7 min; 95% CI, -11.2 to -2.2 min; P = .004 and for lemborexant 10 mg, -8.0 min; 95% CI, -12.5 to -3.5 min; P < .001) was significantly greater for both doses of lemborexant therapy compared with zolpidem therapy measured using polysomnography. Six participants (4 in the zolpidem group and 2 in the lemborexant 5 mg group) reported serious adverse events; none were treatment-related. Other adverse events were mostly mild or moderate in severity.
Conclusions and Relevance


In this randomized clinical trial, lemborexant therapy significantly improved both sleep onset and sleep maintenance, including in the second half of the night, compared with both placebo and zolpidem measured objectively using polysomnography. Lemborexant therapy was well tolerated.
Trial Registrations


ClinicalTrials.gov identifier: NCT02783729; EudraCT identifier: 2015-001463-39.",2019,"Both doses of lemborexant therapy demonstrated statistically significant greater changes from baseline on objective sleep onset as assessed by latency to persistent sleep (log transformed) that was measured using polysomnography at the end of 1 month of treatment (nights 29 and 30) compared with placebo (primary end point for least squares geometric means treatment ratio vs placebo: for lemborexant 5 mg, 0.77; 95% CI, 0.67-0.89; P < .001; for lemborexant 10 mg, 0.72; 95% CI, 0.63-0.83; P < .001).","['phase 3 study conducted at 67 sites in North America and Europe from May 31, 2016, to January 30, 2018', '1006 participants randomized', 'older adults', '10 mg, n\u2009=\u2009269), 869 (86.4%) were women and the median age was 63 years (range, 55-88 years', 'Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1', 'Older Adults With Insomnia Disorder', 'participants with insomnia disorder', 'Participants were 55 years and older with insomnia disorder characterized by reported sleep maintenance difficulties and confirmed by sleep history, sleep diary, and polysomnography']","['zolpidem', 'placebo and zolpidem', 'orexin receptor antagonist lemborexant with placebo and zolpidem tartrate', 'Lemborexant With Placebo', 'Zolpidem Tartrate', 'placebo, zolpidem tartrate extended release (6.25 mg), or lemborexant', 'zolpidem, n\u2009=\u2009263; lemborexant 5 mg, n\u2009=\u2009266; and lemborexant', 'Lemborexant therapy', 'placebo', 'Lemborexant', 'placebo-controlled active-comparator', 'lemborexant therapy vs placebo', 'lemborexant therapy']","['serious adverse events', 'sleep efficiency', 'objective sleep onset', 'sleep onset difficulties', 'sleep efficiency and wake-after-sleep onset compared with placebo, and wake-after-sleep onset', 'sleep onset and sleep maintenance', 'latency to persistent sleep', 'tolerated']","[{'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}]","[{'cui': 'C0078839', 'cui_str': 'zolpidem'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4019081', 'cui_str': 'Orexin Receptor Blockers'}, {'cui': 'C0724725', 'cui_str': 'Zolpidem tartrate'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C4517821', 'cui_str': '6.25'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]",1006.0,0.534433,"Both doses of lemborexant therapy demonstrated statistically significant greater changes from baseline on objective sleep onset as assessed by latency to persistent sleep (log transformed) that was measured using polysomnography at the end of 1 month of treatment (nights 29 and 30) compared with placebo (primary end point for least squares geometric means treatment ratio vs placebo: for lemborexant 5 mg, 0.77; 95% CI, 0.67-0.89; P < .001; for lemborexant 10 mg, 0.72; 95% CI, 0.63-0.83; P < .001).","[{'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Rosenberg', 'Affiliation': 'NeuroTrials Research, Atlanta, Georgia.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Murphy', 'Affiliation': 'ICON, North Wales, Pennsylvania.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Zammit', 'Affiliation': 'Clinilabs, New York, New York.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mayleben', 'Affiliation': 'Community Research, Cincinnati, Ohio.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Kumar', 'Affiliation': 'Eisai Inc, Woodcliff Lake, New Jersey.'}, {'ForeName': 'Shobha', 'Initials': 'S', 'LastName': 'Dhadda', 'Affiliation': 'Eisai Inc, Woodcliff Lake, New Jersey.'}, {'ForeName': 'Gleb', 'Initials': 'G', 'LastName': 'Filippov', 'Affiliation': 'Eisai Inc, Woodcliff Lake, New Jersey.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'LoPresti', 'Affiliation': 'Eisai Inc, Woodcliff Lake, New Jersey.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Moline', 'Affiliation': 'Eisai Inc, Woodcliff Lake, New Jersey.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.18254']
1086,31606605,New Fissure-Attached Nodules in Lung Cancer Screening: A Brief Report From The NELSON Study.,"INTRODUCTION


In incidence lung cancer screening rounds, new pulmonary nodules are regular findings. They have a higher lung cancer probability than baseline nodules. Previous studies have shown that baseline perifissural nodules (PFNs) represent benign lesions. Whether this is also the case for incident PFNs is unknown. This study evaluated newly detected nodules in the Dutch-Belgian randomized-controlled NELSON study with respect to incidence of fissure-attached nodules, their classification, and lung cancer probability.
METHODS


Within the NELSON trial, 7557 participants underwent baseline screening between April 2004 and December 2006. Participants with new nodules detected after baseline were included. Nodules were classified based on location and attachment. Fissure-attached nodules were re-evaluated to be classified as typical, atypical, or non-PFN by two radiologists without knowledge of participant lung cancer status.
RESULTS


One thousand four hundred eighty-four new nodules were detected in 949 participants (77.4% male, median age 59 years [interquartile range: 55-63 years]) in the second, third, and final NELSON screening round. Based on 2-year follow-up or pathology, 1393 nodules (93.8%) were benign. In total, 97 (6.5%) were fissure-attached, including 10 malignant nodules. None of the new fissure-attached malignant nodules was classified as typical or atypical PFN.
CONCLUSIONS


In the NELSON study, 6.5% of incident lung nodules were fissure-attached. None of the lung cancers that originated from a new fissure-attached nodule in the incidence lung cancer screening rounds was classified as a typical or atypical PFN. Our results suggest that also in the case of a new PFN, it is highly unlikely that these PFNs will be diagnosed as lung cancer.",2020,"new nodules were detected in 949 participants (77.4% male, median age 59 [interquartile range: 55-63]) in the second, third and final NELSON screening round.","['7,557 participants underwent baseline screening between April 2004 and December 2006', '949 participants (77.4% male, median age 59 [interquartile range: 55-63]) in the second, third and final NELSON screening round', 'Participants with new nodules detected after baseline were included', 'Lung Cancer Screening']",[],['lung cancer probability'],"[{'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0028259', 'cui_str': 'Nodule (morphologic abnormality)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0281477', 'cui_str': 'Lung cancer screening (procedure)'}]",[],"[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",949.0,0.0339146,"new nodules were detected in 949 participants (77.4% male, median age 59 [interquartile range: 55-63]) in the second, third and final NELSON screening round.","[{'ForeName': 'Daiwei', 'Initials': 'D', 'LastName': 'Han', 'Affiliation': 'Department of Radiology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'Marjolein A', 'Initials': 'MA', 'LastName': 'Heuvelmans', 'Affiliation': 'Department of Epidemiology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands; Department of Pulmonology, Medisch Spectrum Twente, Enschede, Netherlands. Electronic address: m.a.heuvelmans@umcg.nl.'}, {'ForeName': 'Carlijn M', 'Initials': 'CM', 'LastName': 'van der Aalst', 'Affiliation': 'Department of Public Health, Erasmus MC - University Medical Center Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Lisa H', 'Initials': 'LH', 'LastName': 'van Smoorenburg', 'Affiliation': 'Faculty of Medical Sciences, University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Monique D', 'Initials': 'MD', 'LastName': 'Dorrius', 'Affiliation': 'Department of Radiology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'Mieneke', 'Initials': 'M', 'LastName': 'Rook', 'Affiliation': 'Department of Radiology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands; Department of Radiology, Martini Hospital, Groningen, Netherlands.'}, {'ForeName': 'Kristiaan', 'Initials': 'K', 'LastName': 'Nackaerts', 'Affiliation': 'Department of Pulmonary Medicine, KU Leuven, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Joan E', 'Initials': 'JE', 'LastName': 'Walter', 'Affiliation': 'Department of Epidemiology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'Harry J M', 'Initials': 'HJM', 'LastName': 'Groen', 'Affiliation': 'Department of Pulmonology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'Rozemarijn', 'Initials': 'R', 'LastName': 'Vliegenthart', 'Affiliation': 'Department of Radiology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'Harry J', 'Initials': 'HJ', 'LastName': 'de Koning', 'Affiliation': 'Department of Public Health, Erasmus MC - University Medical Center Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Oudkerk', 'Affiliation': 'Faculty of Medical Sciences, University of Groningen, Groningen, Netherlands; iDNA B.V., Groningen, the Netherlands.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2019.09.193']
1087,30335676,Effects of a Classroom Training Program for Promoting Health Literacy Among IT Managers in the Workplace: A Randomized Controlled Trial.,"OBJECTIVE


IT managers have received limited attention in health literacy research, although they are subject to special professional demands. The aim of this study was to evaluate a training program designed to promote health literacy among managers.
METHODS


A randomized controlled trial with a sample of 171 industry managers from one IT company was conducted. Effects of classroom training on health literacy, psychological well-being, self-rated health, and cortisol awakening response were investigated using pre- (t0), post- (t1), and follow-up (t2) surveys.
RESULTS


The intervention effects (time and group) were not significant for the primary outcome of health literacy. At the second measuring point, psychological well-being and self-rated health significantly decreased, and cortisol awakening response significantly increased.
CONCLUSION


Our study did not show beneficial intervention effects of a training program on promoting health literacy.",2019,"At the second measuring point, psychological well-being and self-rated health significantly decreased, and cortisol awakening response significantly increased.
",['171 industry managers from one IT company was conducted'],"['Classroom Training Program', 'classroom training']","['cortisol awakening response', 'health literacy, psychological well-being, self-rated health, and cortisol awakening response', 'Health Literacy', 'psychological well-being and self-rated health', 'health literacy']","[{'cui': 'C0021267', 'cui_str': 'Industry'}, {'cui': 'C0335141', 'cui_str': 'Manager (occupation)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",171.0,0.0396662,"At the second measuring point, psychological well-being and self-rated health significantly decreased, and cortisol awakening response significantly increased.
","[{'ForeName': 'Silja', 'Initials': 'S', 'LastName': 'Fiedler', 'Affiliation': 'Institute of Medical Sociology, Health Services Research, and Rehabilitation Science (IMVR), the University of Cologne, Faculty of Human Sciences and Medical Faculty, Cologne, Germany (Fiedler, Drs Pfaff, Pförtner), and Department of Medical Psychology, Johannes Gutenberg University Mainz, Mainz, Germany (Dr Petrowski).'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Pfaff', 'Affiliation': ''}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Petrowski', 'Affiliation': ''}, {'ForeName': 'Timo-Kolja', 'Initials': 'TK', 'LastName': 'Pförtner', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000001471']
1088,31671276,Eight weeks of fish oil supplementation does not prevent sitting-induced leg endothelial dysfunction.,"Prolonged sitting impairs leg endothelial function and this impairment is thought to be mediated by a sustained reduction in blood flow-induced shear stress. However, whether nutritional strategies can be used to prevent sitting-induced leg endothelial dysfunction remains unknown. Herein, we tested the hypothesis that 8 weeks of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) supplementation would prevent endothelial dysfunction associated with sitting. Nineteen healthy men were randomly assigned to a placebo group or EPA+DHA group in a double-blind fashion. The EPA+DHA group was administered EPA-rich fish oil, containing 600 mg EPA and 260 mg DHA per day for 8 weeks. The placebo group received matching capsules for the same duration of time. Popliteal artery flow-mediated dilation (FMD) was measured at baseline and before and after a 3-h sitting period. During sitting, blood pressure, popliteal artery diameter, and blood velocity were measured every hour. Throughout the sitting period, popliteal artery blood flow and shear rate were markedly and similarly reduced in both groups ( P  < 0.05). However, counter to the hypothesis, 3 h of sitting impaired popliteal artery FMD to the same extent in both groups ( P  < 0.05). In conclusion, daily EPA and DHA supplementation is not effective at preventing the detrimental effects of prolonged sitting on leg endothelial function.  Novelty  We provide evidence that sitting-induced leg endothelial dysfunction in young healthy subjects cannot be remediated by a nutritional strategy known to produce cardiovascular benefits. This could be partially due to the low total dose of EPA and DHA administered.",2020,"However, three hours of sitting impaired popliteal artery FMD to the same extent in both groups (P < 0.05).","['Nineteen healthy men', 'young healthy subjects']","['EPA-rich fish oil, containing 600 mg EPA', 'EPA+DHA', 'eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) supplementation', 'placebo', 'fish oil supplementation', 'EPA and DHA supplementation', 'Prolonged sitting']","['popliteal artery blood flow and shear rate', 'blood pressure, popliteal artery diameter and blood velocity', 'Novelty', 'Popliteal artery flow-mediated dilation (FMD', 'popliteal artery FMD', 'sitting-induced leg endothelial dysfunction']","[{'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0556102', 'cui_str': 'DHA - Docosahexaenoic acid supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}]","[{'cui': 'C0032649', 'cui_str': 'Popliteal Artery'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C1531610', 'cui_str': 'Blood velocity'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}]",19.0,0.176063,"However, three hours of sitting impaired popliteal artery FMD to the same extent in both groups (P < 0.05).","[{'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Morishima', 'Affiliation': 'Sports Research Center, Hosei University, Kawasaki 211-0031, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Tsuchiya', 'Affiliation': 'Faculty of Modern Life, Teikyo Heisei University, Tokyo 164-8530, Japan.'}, {'ForeName': 'Jaume', 'Initials': 'J', 'LastName': 'Padilla', 'Affiliation': 'Department of Nutrition and Exercise Physiology, University of Missouri, Columbia, MO 65211, USA.'}, {'ForeName': 'Eisuke', 'Initials': 'E', 'LastName': 'Ochi', 'Affiliation': 'Sports Research Center, Hosei University, Kawasaki 211-0031, Japan.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0138']
1089,31857319,Prostate cancer androgen receptor splice variant 7 biomarker study - a multicentre randomised feasibility trial of biomarker-guided personalised treatment in patients with advanced prostate cancer (the VARIANT trial) study protocol.,"INTRODUCTION


Prostate cancer is the most common male cancer with one in four developing non-curable metastatic disease. Initial treatment responses to hormonal therapies are transient and further management options lie between (1) further hormone therapy or (2) a non-hormonal approach involving additional chemotherapy or molecular radiotherapy (radium-223). There is no clear rationale for choosing between these mechanistically different treatment approaches. The biology of hormone resistance is driven through abnormal androgen receptor activity and we can assay this through a blood test measuring androgen receptor variant 7 (AR-V7) expression in circulating tumour cells. Despite increasing evidence supporting AR-V7's role as a prognostic marker, the clinical utility of such measures remains unknown in helping personalise treatment decisions.
METHODS AND DESIGN


The VARIANT feasibility trial is a pragmatic design, to be run over 18 months with participants randomised into the intervention arm receiving biomarker (AR-V7) guided clinical treatment and participants randomised into the control arm with conventional standard management (no biomarker guidance). AR-V7 positive participants (likely to be insensitive to further hormone treatment) will receive chemotherapy or in other cases radium-223 (where routinely available). Seventy male ≥18 years old participants with metastatic castrate resistant prostate cancer clinically indicated to proceed to further hormone therapy or chemotherapy, will be recruited from three National Health Service Trusts based in England, Scotland and Wales. The feasibility primary outcome is willingness of patients to be randomised and clinicians to recruit to a biomarker-based treatment strategy, with trial data informing the basis of a definitive and appropriately powered randomised control trial.
ETHICS AND DISSEMINATION


Formal ethics review was undertaken with a favourable opinion, through Wales NRES Committee 2 18/WA/0419. Findings to be disseminated through patient and professional organisations that have expressed their support, media outlets and peer-reviewed journal publication.
TRIAL REGISTRATION NUMBER


ISRCTN10246848; pre-results.",2019,"The feasibility primary outcome is willingness of patients to be randomised and clinicians to recruit to a biomarker-based treatment strategy, with trial data informing the basis of a definitive and appropriately powered randomised control trial.
","['Seventy male ≥18 years old participants with metastatic castrate resistant prostate cancer clinically indicated to proceed to further hormone therapy or chemotherapy, will be recruited from three National Health Service Trusts based in England, Scotland and Wales', 'patients with advanced prostate cancer']","['biomarker-guided personalised treatment', 'control arm with conventional standard management (no biomarker guidance', 'chemotherapy or molecular radiotherapy (radium-223', 'intervention arm receiving biomarker (AR-V7) guided clinical treatment']",[],"[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1328504', 'cui_str': 'Castration-resistant prostate cancer'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0303282', 'cui_str': 'Ra-223 radioisotope'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",[],70.0,0.178296,"The feasibility primary outcome is willingness of patients to be randomised and clinicians to recruit to a biomarker-based treatment strategy, with trial data informing the basis of a definitive and appropriately powered randomised control trial.
","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Clark', 'Affiliation': 'Translational and Clinical Research Institute, NU Cancer, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK emma.clark@ncl.ac.uk.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Morton', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'Shriya', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Fisher', 'Affiliation': 'Population Health Sciences, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Howel', 'Affiliation': 'Population Health Sciences, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'Jenn', 'Initials': 'J', 'LastName': 'Walker', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Wood', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hancock', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Maier', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': 'Trial Managment Group, VARIANT Trial, Newcastle-Upon-Tyne, UK.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Bahl', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, Bristol, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Crabb', 'Affiliation': 'University of Southampton, Southampton, UK.'}, {'ForeName': 'Suneil', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': ""Queen's University Belfast, Belfast, Belfast, UK.""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Pedley', 'Affiliation': 'Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, Newcastle upon Tyne, UK.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'University of Glasgow, Glasgow, Glasgow, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Staffurth', 'Affiliation': 'Research, Velindre Cancer Centre, Cardiff, Cardiff, UK.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Heer', 'Affiliation': 'Translational and Clinical Research Institute, NU Cancer, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}]",BMJ open,['10.1136/bmjopen-2019-034708']
1090,31474282,Bolstering trust and reducing discipline incidents at a diverse middle school: How self-affirmation affects behavioral conduct during the transition to adolescence.,"A three-year field experiment at an ethnically diverse middle school (N = 163) tested the hypothesis that periodic self-affirmation exercises delivered by classroom teachers bolsters students' school trust and improves their behavioral conduct. Students were randomly assigned to either a self-affirmation condition, where they wrote a series of in-class essays about personally important values, or a control condition, where they wrote essays about personally unimportant values. There were no behavioral effects of affirmation at the end of 6th grade, after students had completed four writing exercises. However, after four additional exercises in 7th grade, affirmed students had a significantly lower rate of discipline incidents than students in the control condition. The effect continued to grow and did not differ across ethnic groups, such that during 8th grade students in the affirmation condition on average received discipline at a 69% lower rate than students in the control condition. Analyses of student climate surveys revealed that affirmation was associated with higher school trust over time, a tendency that held across ethnic groups and partially mediated the affirmation effect on discipline. Repeated self-affirmation can bolster students' school trust and reduce the incidence of discipline in middle school, findings with both theoretical and practical implications.",2019,"There were no behavioral effects of affirmation at the end of 6th grade, after students had completed four writing exercises.",['ethnically diverse middle school (N\u202f=\u202f163'],"[""periodic self-affirmation exercises delivered by classroom teachers bolsters students' school trust and improves their behavioral conduct""]",['rate of discipline incidents'],"[{'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}]","[{'cui': 'C0332182', 'cui_str': 'Periodic (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",[],,0.0178882,"There were no behavioral effects of affirmation at the end of 6th grade, after students had completed four writing exercises.","[{'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Binning', 'Affiliation': 'University of Pittsburgh, Department of Psychology, Learning Research and Development Center, United States of America. Electronic address: kbinning@pitt.edu.'}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Cook', 'Affiliation': 'Pennsylvania State University, Department of Psychology, United States of America.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Purdie-Greenaway', 'Affiliation': 'Columbia University, Department of Psychology, United States of America.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Garcia', 'Affiliation': 'Stanford University, Graduate School of Education, United States of America.'}, {'ForeName': 'Susie', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'University of Pittsburgh, Department of Psychology, Learning Research and Development Center, United States of America.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Apfel', 'Affiliation': 'Yale University, Department of Psychology, United States of America.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Sherman', 'Affiliation': 'University of California, Santa Barbara, Department of Psychological and Brain Sciences, United States of America.'}, {'ForeName': 'Geoffrey L', 'Initials': 'GL', 'LastName': 'Cohen', 'Affiliation': 'Stanford University, Graduate School of Education, Department of Psychology, United States of America.'}]",Journal of school psychology,['10.1016/j.jsp.2019.07.007']
1091,31722024,Effect of Intranasal vs Intramuscular Naloxone on Opioid Overdose: A Randomized Clinical Trial.,"Importance


Previous unblinded clinical trials suggested that the intranasal route of naloxone hydrochloride was inferior to the widely used intramuscular route for the reversal of opioid overdose.
Objective


To test whether a dose of naloxone administered intranasally is as effective as the same dose of intramuscularly administered naloxone in reversing opioid overdose.
Design, Setting, and Participants


A double-blind, double-dummy randomized clinical trial was conducted at the Uniting Medically Supervised Injecting Centre in Sydney, Australia. Clients of the center were recruited to participate from February 1, 2012, to January 3, 2017. Eligible clients were aged 18 years or older with a history of injecting drug use (n = 197). Intention-to-treat analysis was performed for all participants who received both intranasal and intramuscular modes of treatment (active or placebo).
Interventions


Clients were randomized to receive 1 of 2 treatments: (1) intranasal administration of naloxone hydrochloride 800 μg per 1 mL and intramuscular administration of placebo 1 mL or (2) intramuscular administration of naloxone hydrochloride 800 μg per 1 mL and intranasal administration of placebo 1 mL.
Main Outcomes and Measures


The primary outcome measure was the need for a rescue dose of intramuscular naloxone hydrochloride (800 μg) 10 minutes after the initial treatment. Secondary outcome measures included time to adequate respiratory rate greater than or equal to 10 breaths per minute and time to Glasgow Coma Scale score greater than or equal to 13.
Results


A total of 197 clients (173 [87.8%] male; mean [SD] age, 34.0 [7.82] years) completed the trial, of whom 93 (47.2%) were randomized to intramuscular naloxone dose and 104 (52.8%) to intranasal naloxone dose. Clients randomized to intramuscular naloxone administration were less likely to require a rescue dose of naloxone compared with clients randomized to intranasal naloxone administration (8 [8.6%] vs 24 [23.1%]; odds ratio, 0.35; 95% CI, 0.15-0.66; P = .002). A 65% increase in hazard (hazard ratio, 1.65; 95% CI, 1.21-2.25; P = .002) for time to respiratory rate of at least 10 and an 81% increase in hazard (hazard ratio, 1.81; 95% CI, 1.28-2.56; P = .001) for time to Glasgow Coma Scale score of at least 13 were observed for the group receiving intranasal naloxone compared with the group receiving intramuscular naloxone. No major adverse events were reported for either group.
Conclusions and Relevance


This trial showed that intranasally administered naloxone in a supervised injecting facility can reverse opioid overdose but not as efficiently as intramuscularly administered naloxone can, findings that largely replicate those of previous unblinded clinical trials. These results suggest that determining the optimal dose and concentration of intranasal naloxone to respond to opioid overdose in real-world conditions is an international priority.
Trial Registration


anzctr.org.au Identifier: ACTRN12611000852954.",2019,"A 65% increase in hazard (hazard ratio, 1.65; 95% CI, 1.21-2.25; P = .002) for time to respiratory rate of at least 10 and an 81% increase in hazard (hazard ratio, 1.81; 95% CI, 1.28-2.56; P = .001) for time to Glasgow Coma Scale score of at least 13 were observed for the group receiving intranasal naloxone compared with the group receiving intramuscular naloxone.","['Eligible clients were aged 18 years or older with a history of injecting drug use (n\u2009=\u2009197', 'Clients of the center were recruited to participate from February 1, 2012, to January 3, 2017', 'A total of 197 clients (173 [87.8%] male; mean [SD] age, 34.0 [7.82] years) completed the trial, of whom 93 (47.2', 'Uniting Medically Supervised Injecting Centre in Sydney, Australia']","['anzctr.org.au Identifier', 'intranasal and intramuscular modes of treatment (active or placebo', 'placebo 1 mL.\nMain Outcomes and Measures', 'intramuscular naloxone', 'naloxone hydrochloride 800 μg per 1 mL and intramuscular administration of placebo 1 mL or (2) intramuscular administration of naloxone hydrochloride', 'naloxone', 'Intranasal vs Intramuscular Naloxone', 'intranasal naloxone', 'naloxone hydrochloride']","['Opioid Overdose', 'time to respiratory rate', 'time to Glasgow Coma Scale score', 'time to adequate respiratory rate greater than or equal to 10 breaths per minute and time to Glasgow Coma Scale score']","[{'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0700549', 'cui_str': 'Naloxone Hydrochloride'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0029944', 'cui_str': 'Drug Overdose'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439386', 'cui_str': 'breaths per minute'}]",197.0,0.34555,"A 65% increase in hazard (hazard ratio, 1.65; 95% CI, 1.21-2.25; P = .002) for time to respiratory rate of at least 10 and an 81% increase in hazard (hazard ratio, 1.81; 95% CI, 1.28-2.56; P = .001) for time to Glasgow Coma Scale score of at least 13 were observed for the group receiving intranasal naloxone compared with the group receiving intramuscular naloxone.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dietze', 'Affiliation': 'Behaviours and Health Risks Program, Burnet Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Jauncey', 'Affiliation': 'Uniting Medically Supervised Injecting Centre, Kings Cross, New South Wales, Australia.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Salmon', 'Affiliation': 'Uniting Medically Supervised Injecting Centre, Kings Cross, New South Wales, Australia.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Mohebbi', 'Affiliation': 'Biostatistics Unit, Faculty of Health, Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Latimer', 'Affiliation': 'Uniting Medically Supervised Injecting Centre, Kings Cross, New South Wales, Australia.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'van Beek', 'Affiliation': 'South Eastern Sydney Local Health District, New South Wales, Australia.'}, {'ForeName': 'Colette', 'Initials': 'C', 'LastName': 'McGrath', 'Affiliation': 'Justice Health Forensic Mental Health Network, New South Wales Health, Randwick, New South Wales, Australia.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Kerr', 'Affiliation': 'Centre for Quality and Patient Safety, School of Nursing and Midwifery, Deakin University, Geelong, Australia.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.14977']
1092,31862329,Computerized Advisory Decision Support for Cardiovascular Diseases in Primary Care: A Cluster Randomized Trial.,"PURPOSE


The purpose of this research was to evaluate the impact of an outpatient computerized advisory clinical decision support system (CDSS) on adherence to guideline-recommended treatment for heart failure, atrial fibrillation, and hyperlipidemia.
METHODS


Twenty care teams (109 clinicians) in a primary care practice were cluster-randomized to either access or no access to an advisory CDSS integrated into the electronic medical record. For patients with an outpatient visit, the CDSS determined if they had heart failure with reduced ejection fraction, hyperlipidemia, or atrial fibrillation; and if so, was the patient receiving guideline-recommended treatment. In the intervention group, an alert was visible in the medical record if there was a discrepancy between current and guideline-recommended treatment. Clicking the alert displayed the treatment discrepancy and recommended treatment. Outcomes included prescribing patterns, self-reported use of decision aids, and self-reported efficiency. The trial was conducted between May 1 and November 15, 2016, and incorporated 16,310 patient visits.
RESULTS


The advisory CDSS increased adherence to guideline-recommended treatment for heart failure (odds ratio [OR] 7.6, 95% confidence interval [CI], 1.2, 47.5) but had no impact in atrial fibrillation (OR 0.94, 95% CI 0.15, 5.94) or hyperlipidemia (OR 1.1, 95% CI 0.6, 1.8). Clinicians with access to the CDSS self-reported greater use of risk assessment tools for heart failure (3.6 [1.1] vs 2.7 [1.0], mean [standard deviation] on a 5-point scale) but not for atrial fibrillation or hyperlipidemia. The CDSS did not impact self-assessed efficiency. The overall usage of the CDSS was low (19%).
CONCLUSIONS


A computerized advisory CDSS improved adherence to guideline-recommended treatment for heart failure but not for atrial fibrillation or hyperlipidemia.",2020,A computerized advisory CDSS improved adherence to guideline-recommended treatment for heart failure but not for atrial fibrillation or hyperlipidemia.,"['May 1 and November 15, 2016 and incorporated 16,310 patient visits', 'Twenty care teams (109 clinicians) in a primary care practice were cluster-randomized to either', 'Primary Care']","['outpatient computerized advisory clinical decision support system (CDSS', 'access or no access to an advisory CDSS integrated into the electronic medical record']","['hyperlipidemia', 'prescribing patterns, self-reported use of decision aids and self-reported efficiency', 'heart failure with reduced ejection fraction, hyperlipidemia, and/or atrial fibrillation', 'overall usage of the CDSS', 'atrial fibrillation or hyperlipidemia', 'atrial fibrillation', 'heart failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0525070', 'cui_str': 'Decision Support Systems, Clinical'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}]","[{'cui': 'C0020473', 'cui_str': 'Hyperlipemia'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}]",,0.0365495,A computerized advisory CDSS improved adherence to guideline-recommended treatment for heart failure but not for atrial fibrillation or hyperlipidemia.,"[{'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'McKie', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minn. Electronic address: mckie.paul@mayo.edu.'}, {'ForeName': 'Daryl J', 'Initials': 'DJ', 'LastName': 'Kor', 'Affiliation': 'Robert D and Patricia E Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minn; Department of Anesthesiology, Mayo Clinic, Rochester, Minn.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Cook', 'Affiliation': 'Office of Information and Knowledge Management, Mayo Clinic, Rochester, Minn; Division of General Internal Medicine, Department of Medicine, Mayo Clinic, Rochester, Minn.'}, {'ForeName': 'Maya E', 'Initials': 'ME', 'LastName': 'Kessler', 'Affiliation': 'Division of Primary Care Internal Medicine, Department of Medicine, Mayo Clinic, Rochester, Minn.'}, {'ForeName': 'Rickey E', 'Initials': 'RE', 'LastName': 'Carter', 'Affiliation': 'Robert D and Patricia E Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minn; Department of Health Sciences Research, Mayo Clinic, Rochester, Minn.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Wilson', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, Minn.'}, {'ForeName': 'Laurie J', 'Initials': 'LJ', 'LastName': 'Pencille', 'Affiliation': 'Robert D and Patricia E Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minn; Office of Information and Knowledge Management, Mayo Clinic, Rochester, Minn.'}, {'ForeName': 'Branden C', 'Initials': 'BC', 'LastName': 'Hickey', 'Affiliation': 'Office of Information and Knowledge Management, Mayo Clinic, Rochester, Minn.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Chaudhry', 'Affiliation': 'Office of Information and Knowledge Management, Mayo Clinic, Rochester, Minn; Division of Primary Care Internal Medicine, Department of Medicine, Mayo Clinic, Rochester, Minn.'}]",The American journal of medicine,['10.1016/j.amjmed.2019.10.039']
1093,31860110,Effect of Parental Counseling on Infants' Healthy Sleep Habits in Brazil: A Randomized Clinical Trial.,"Importance


Poor sleep during early childhood is associated with adverse outcomes, including obesity, cognitive impairment, and mental and behavioral disorders.
Objective


To assess the efficacy of an educational intervention in the promotion of nighttime sleep duration.
Design, Setting, and Participants


This single-blind, intent-to-treat randomized clinical trial included participants in Pelotas, Brazil, aged 3 months who were followed up until age 24 months. Eligibility criteria included healthy infants aged approximately 3 months who slept less than 15 hours per 24 hours. Infants were randomized to the intervention group or control group.
Interventions


Information on sleep characteristics, improvements in the environment, establishment of a nighttime sleep routine, and waiting before attending nocturnal awakenings was delivered to mothers in the intervention group by trained home-visitors at baseline. The intervention group received a telephone call on the first and second day after the intervention and a home visit on the third day after the intervention. The intervention's content was reinforced at health care visits for ages 6 months and 12 months. Mothers allocated to the control group were counseled on the benefits of breastfeeding for the mother's and child's health and given written material with content on breastfeeding.
Main Outcomes and Measures


Nighttime sleep duration was measured by interview and actigraphy at baseline and ages 6, 12, and 24 months and diaries at baseline and age 6 months. At ages 3 and 6 months, nighttime sleep self-regulation was calculated by subtracting nighttime sleep duration recorded by actigraphy from nighttime sleep duration recorded in the diaries and at ages 12 and 24 months by subtracting nighttime sleep duration recorded by actigraphy from nighttime sleep duration obtained by interview.
Results


Among 1812 mother-infant dyads invited to participate, 798 met the inclusion criteria and 586 agreed to participate. The intervention group included 298 infants (154 [52.9%] boys), and the control group included 288 infants (164 [58.2%] boys). At age 6 months, mean (SD) nighttime sleep duration recorded in diaries was 9.80 (1.85) hours in the intervention group and 9.49 (2.07) hours in the control group, a difference of 19 minutes longer for the intervention group. At age 12 months, mean (SD) nighttime sleep duration based on the Brief Infant Sleep Questionnaire was 8.43 (1.35) hours in the intervention group and 8.52 (1.35) hours in the control group, a difference of 5 minutes shorter for the intervention group. At age 24 months, compared with information from the interview, actigraphy records showed that children in the intervention group stayed awake at night without signalizing for a mean (SD) of 0.52 (2.52) hours, whereas children in the control group stayed awake at night without signalizing for a mean (SD) of 0.23 (2.43) hours. There were no statistically significant difference between groups in any of the sleep parameters investigated.
Conclusions and Relevance


This randomized clinical trial found that the educational intervention did not achieve longer nighttime sleep duration among infants in the intervention group.
Trial Registration


ClinicalTrials.gov identifier: NCT02788630.",2019,"There were no statistically significant difference between groups in any of the sleep parameters investigated.
","['participants in Pelotas, Brazil, aged 3 months who were followed up until age 24 months', '298 infants (154 [52.9%] boys), and the control group included 288 infants (164 [58.2%] boys', '1812 mother-infant dyads invited to participate, 798 met the inclusion criteria and 586 agreed to participate', ""Infants' Healthy Sleep Habits in Brazil"", 'Eligibility criteria included healthy infants aged approximately 3 months who slept less than 15 hours per 24 hours']","['educational intervention', 'intervention group or control group', 'Parental Counseling', ""breastfeeding for the mother's and child's health and given written material with content on breastfeeding"", 'telephone call']","['sleep characteristics, improvements in the environment, establishment of a nighttime sleep routine, and waiting before attending nocturnal awakenings', 'mean (SD) nighttime sleep duration based on the Brief Infant Sleep Questionnaire', 'mean (SD) nighttime sleep duration recorded in diaries', 'nighttime sleep self-regulation', 'Measures\n\n\nNighttime sleep duration', 'nighttime sleep duration']","[{'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0456696', 'cui_str': '/24h'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0860510', 'cui_str': 'Nocturnal awakening'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",1812.0,0.0716626,"There were no statistically significant difference between groups in any of the sleep parameters investigated.
","[{'ForeName': 'Iná S', 'Initials': 'IS', 'LastName': 'Santos', 'Affiliation': 'Postgraduate Program in Epidemiology, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Del-Ponte', 'Affiliation': 'Postgraduate Program in Epidemiology, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Tovo-Rodrigues', 'Affiliation': 'Postgraduate Program in Epidemiology, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Camila S', 'Initials': 'CS', 'LastName': 'Halal', 'Affiliation': ""Nossa Senhora da Conceição Children's Hospital, Brazilian Ministry of Health, Porto Alegre, Brazil.""}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Matijasevich', 'Affiliation': 'Postgraduate Program in Epidemiology, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Suélen', 'Initials': 'S', 'LastName': 'Cruz', 'Affiliation': 'Postgraduate Program in Epidemiology, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Anselmi', 'Affiliation': 'Postgraduate Program in Epidemiology, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Mariângela Freitas', 'Initials': 'MF', 'LastName': 'Silveira', 'Affiliation': 'Postgraduate Program in Epidemiology, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Pedro R Curi', 'Initials': 'PRC', 'LastName': 'Hallal', 'Affiliation': 'Postgraduate Program in Epidemiology, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Diego G', 'Initials': 'DG', 'LastName': 'Bassani', 'Affiliation': 'Department of Paediatrics, The Hospital for Sick Children, Research Institute, University of Toronto, Toronto, Ontario, Canada.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.18062']
1094,31652407,"Consumption of Greek yogurt during 12 weeks of high-impact loading exercise increases bone formation in young, adult males - a secondary analysis from a randomized trial.","Exercise combined with protein and calcium has been shown to benefit bone turnover and bone metabolism. Greek yogurt (GY) contains important nutrients that support bone but has yet to be studied with exercise for this purpose. Thirty untrained, university-aged, males were randomized to 2 groups ( n  = 15/group): GY (20 g protein, 208 mg calcium/dose) or placebo pudding (PP; 0 g protein, 0 g calcium/dose) consumed 3×/day on training days and 2×/day on nontraining days. Both groups underwent a resistance/plyometric training program for 12 weeks. Blood was obtained at weeks 0, 1, and 12 to measure procollagen-type-I-N-terminal-propeptide (P1NP) and C-terminal-telopeptide (CTX). After outlier treatment, P1NP increased more over time in GY versus PP ( p  = 0.002; interaction). Both groups decreased CTX over time ( p  = 0.046; time effect). Following 1 week of training, there was a trend towards a significant increase in CTX in PP with no change in GY ( p  = 0.062; interaction). P1NP changed more in GY than PP (baseline to week 12;  p  = 0.029) as did the P1NP/CTX ratio ( p  = 0.015) indicating a greater increase in formation with GY. Thus, GY added to a high-load, high-impact exercise program positively shifted bone turnover towards increased formation while attenuating resorption. GY could be a plausible postexercise food to support bone health in young adult males.  Novelty  Greek yogurt, with exercise, increased bone formation in young adult males over 12 weeks. After 1 week of an osteogenic exercise program, Greek yogurt tended to blunt a rise in bone resorption seen with the placebo. Greek yogurt is a plausible postexercise food that supports bone.",2020,"After outlier treatment, P1NP increased more over time in GY versus PP (P=0.002; interaction).","['Thirty untrained, university-aged, males', 'young adult males', 'Young, Adult Males ']","['osteogenic exercise program', 'GY (20g protein, 208mg calcium/dose) or Placebo Pudding (PP; 0g protein, 0g calcium/dose) consumed 3x/d on training days and 2x/d on non-training days', 'placebo', 'resistance/plyometric training program', 'Exercise combined with protein and calcium', 'Loading Exercise']","['P1NP', 'bone formation', 'CTX in PP']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0450403', 'cui_str': '20G (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0530867', 'cui_str': 'G13 Protein'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Training'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0029433', 'cui_str': 'Ossification'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]",,0.0481823,"After outlier treatment, P1NP increased more over time in GY versus PP (P=0.002; interaction).","[{'ForeName': 'Aaron D', 'Initials': 'AD', 'LastName': 'Bridge', 'Affiliation': 'Department of Kinesiology, Faculty of Applied Health Sciences, Brock University, St. Catharines, ON L2S 3A1, Canada.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'School of Kinesiology and Health Science, Faculty of Health, York University, Toronto, ON M3J 1P3, Canada.'}, {'ForeName': 'Hayden', 'Initials': 'H', 'LastName': 'Snider', 'Affiliation': 'School of Kinesiology and Health Science, Faculty of Health, York University, Toronto, ON M3J 1P3, Canada.'}, {'ForeName': 'Wendy E', 'Initials': 'WE', 'LastName': 'Ward', 'Affiliation': 'Department of Kinesiology, Faculty of Applied Health Sciences, Brock University, St. Catharines, ON L2S 3A1, Canada.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Roy', 'Affiliation': 'Department of Kinesiology, Faculty of Applied Health Sciences, Brock University, St. Catharines, ON L2S 3A1, Canada.'}, {'ForeName': 'Andrea R', 'Initials': 'AR', 'LastName': 'Josse', 'Affiliation': 'School of Kinesiology and Health Science, Faculty of Health, York University, Toronto, ON M3J 1P3, Canada.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0396']
1095,31866419,Effectiveness of Powerful Tools for Caregivers on Caregiver Burden and on Care Recipient Behavioral and Psychological Symptoms of Dementia: A Randomized Controlled Trial.,"OBJECTIVE


The aim of this study was to evaluate the effectiveness of a psychoeducational intervention, Powerful Tools for Caregivers (PTC), for family caregivers of individuals with dementia.
DESIGN


A pragmatic, 2-arm randomized controlled trial compared the PTC intervention, as delivered in practice, to usual care. Participants randomized to usual care functioned as a control group and then received the PTC intervention.
INTERVENTION


PTC is a 6-week manualized program that includes weekly 2-hour classes in a group setting facilitated by 2 trained and certified leaders. The educational program helps caregivers to enhance self-care practices and manage emotional distress.
SETTING AND PARTICIPANTS


Two stakeholder organizations delivered the intervention in community settings. Participants were family caregivers of individuals with dementia recruited from the community in Florida.
METHODS


Primary outcomes were caregiver burden and behavioral and psychological symptoms of dementia of the care recipient. Secondary outcomes included caregiver depressive symptoms, self-efficacy, self-rated health, and life satisfaction. Measures were collected at baseline (n = 60 participants), postintervention (n = 55), and at 6-week follow-up (n = 44).
RESULTS


Intent-to-treat analyses found PTC reduced caregiver burden (d = -0.48) and depressive symptoms (d = -0.53), and increased self-confidence (d = 0.68), but found no significant benefit for behavioral and psychological symptoms of dementia in care recipients. PTC was rated highly by participants and program attrition was low, with 94% of caregivers completing at least 4 of the 6 classes.
CONCLUSIONS AND IMPLICATIONS


Although no significant effects were found for behavioral and psychological symptoms of dementia, this trial supports the effectiveness of PTC to improve caregiver outcomes as delivered in the community.",2019,"RESULTS


Intent-to-treat analyses found PTC reduced caregiver burden (d = -0.48) and depressive symptoms (d = -0.53), and increased self-confidence (d = 0.68), but found no significant benefit for behavioral and psychological symptoms of dementia in care recipients.","['Participants were family caregivers of individuals with dementia recruited from the community in Florida', 'Caregivers (PTC), for family caregivers of individuals with dementia', 'Caregivers on Caregiver Burden and on Care Recipient Behavioral and Psychological Symptoms of Dementia']","['PTC intervention', 'PTC', 'psychoeducational intervention']","['caregiver burden and behavioral and psychological symptoms of dementia of the care recipient', 'self-confidence', 'caregiver depressive symptoms, self-efficacy, self-rated health, and life satisfaction', 'behavioral and psychological symptoms of dementia', 'depressive symptoms', 'PTC reduced caregiver burden']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0016253', 'cui_str': 'Florida'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C4285807', 'cui_str': 'Neuropsychiatric symptoms'}]","[{'cui': 'C0015491', 'cui_str': 'factor IX'}]","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C4285807', 'cui_str': 'Neuropsychiatric symptoms'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0015491', 'cui_str': 'factor IX'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",60.0,0.178322,"RESULTS


Intent-to-treat analyses found PTC reduced caregiver burden (d = -0.48) and depressive symptoms (d = -0.53), and increased self-confidence (d = 0.68), but found no significant benefit for behavioral and psychological symptoms of dementia in care recipients.","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Terracciano', 'Affiliation': 'College of Medicine, Florida State University, Tallahassee, FL. Electronic address: antonio.terracciano@med.fsu.edu.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Artese', 'Affiliation': 'Health and Human Performance, Roanoke College, Salem, VA.'}, {'ForeName': 'Jenie', 'Initials': 'J', 'LastName': 'Yeh', 'Affiliation': 'College of Medicine, Florida State University, Tallahassee, FL.'}, {'ForeName': 'LaVon', 'Initials': 'L', 'LastName': 'Edgerton', 'Affiliation': 'College of Medicine, Florida State University, Tallahassee, FL.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Granville', 'Affiliation': 'College of Medicine, Florida State University, Tallahassee, FL.'}, {'ForeName': 'Damaris', 'Initials': 'D', 'LastName': 'Aschwanden', 'Affiliation': 'College of Medicine, Florida State University, Tallahassee, FL.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Luchetti', 'Affiliation': 'College of Medicine, Florida State University, Tallahassee, FL.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Glueckauf', 'Affiliation': 'College of Medicine, Florida State University, Tallahassee, FL.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Stephan', 'Affiliation': 'Euromov, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Angelina R', 'Initials': 'AR', 'LastName': 'Sutin', 'Affiliation': 'College of Medicine, Florida State University, Tallahassee, FL.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Katz', 'Affiliation': 'College of Medicine, Florida State University, Tallahassee, FL.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.11.011']
1096,31880795,Single-Nucleotide Polymorphism-Based Genetic Risk Score and Patient Age at Prostate Cancer Diagnosis.,"Importance


Few studies have evaluated the association between a single-nucleotide polymorphism-based genetic risk score (GRS) and patient age at prostate cancer (PCa) diagnosis.
Objectives


To test the association between a GRS and patient age at PCa diagnosis and to compare the performance of a GRS with that of family history (FH) in PCa risk stratification.
Design, Setting, and Participants


A cohort study of 3225 white men was conducted as a secondary analysis of the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) chemoprevention trial, a 4-year, randomized, double-blind, placebo-controlled multicenter study conducted from March 2003 to April 2009 to evaluate the safety and efficacy of dutasteride in reducing PCa events. Participants were confirmed to be cancer free by prostate biopsy (6-12 cores) within 6 months prior to the study and underwent 10 core biopsies every 2 years per protocol. The dates for performing data analysis were from July 2016 to October 2019.
Interventions


A well-established, population-standardized GRS was calculated for each participant based on 110 known PCa risk-associated single-nucleotide polymorphisms, which is a relative risk compared with the general population. Men were classified into 3 GRS risk groups based on predetermined cutoff values: low (<0.50), average (0.50-1.49), and high (≥1.50).
Main Outcomes and Measures


Prostate cancer diagnosis-free survival among men of different risk groups.
Results


Among 3225 men (median age, 63 years [interquartile range, 58-67 years]) in the study, 683 (21%) were classified as low risk, 1937 (60%) as average risk, and 605 (19%) as high risk based on GRS alone. In comparison, 2789 (86%) were classified as low or average risk and 436 (14%) as high risk based on FH alone. Men in higher GRS risk groups had a PCa diagnosis-free survival rate that was worse than that of those in the lower GRS risk group (χ2 = 53.3; P < .001 for trend) and in participants with a negative FH of PCa (χ2 = 45.5; P < .001 for trend). Combining GRS and FH further stratified overall genetic risk, indicating that 957 men (30%) were at high genetic risk (either high GRS or positive FH), 1667 men (52%) were at average genetic risk (average GRS and negative FH), and 601 men (19%) were at low genetic risk (low GRS and negative FH). The median PCa diagnosis-free survival was 74 years (95% CI, 73-75 years) for men at high genetic risk, 77 years (95% CI, 75 to >80 years) for men at average genetic risk, and more than 80 years (95% CI, >80 to >80 years) for men at low genetic risk. In contrast, the median PCa diagnosis-free survival was 73 years (95% CI, 71-76 years) for men with a positive FH and 77 years (95% CI, 76-79 years) for men with a negative FH.
Conclusions and Relevance


This study suggests that a GRS is significantly associated with patient age at PCa diagnosis. Combining FH and GRS may better stratify inherited risk than FH alone for developing personalized PCa screening strategies.",2019,Men in higher GRS risk groups had a PCa diagnosis-free survival rate that was worse than that of those in the lower GRS risk group (χ2 = 53.3; P < .001 for trend) and in participants with a negative FH of PCa (χ2 = 45.5; P < .001 for trend).,"['Men were classified into 3 GRS risk groups based on predetermined cutoff values: low (<0.50), average (0.50-1.49), and high (≥1.50', '3225 white men', '3225 men (median age, 63 years [interquartile range, 58-67 years]) in the study, 683 (21%) were classified as low risk, 1937 (60%) as average risk, and 605 (19%) as high risk based on GRS alone', 'Participants were confirmed to be cancer free by prostate biopsy (6-12 cores) within 6 months prior to the study and underwent 10 core biopsies every 2 years per protocol', '75 to >80 years) for men at average genetic risk, and more than 80 years (95% CI, >80 to >80 years) for men at low genetic risk', '957 men (30%) were at high genetic risk (either high GRS or positive FH), 1667 men (52%) were at average genetic risk (average GRS and negative FH), and 601 men (19%) were at low genetic risk (low GRS and negative FH']","['placebo', 'dutasteride']","['PCa events', 'PCa diagnosis-free survival rate', 'median PCa diagnosis-free survival', 'Measures\n\n\nProstate cancer diagnosis-free survival']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4708909', 'cui_str': '1667 (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0754659', 'cui_str': 'Dutasteride'}]","[{'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]",1667.0,0.0845362,Men in higher GRS risk groups had a PCa diagnosis-free survival rate that was worse than that of those in the lower GRS risk group (χ2 = 53.3; P < .001 for trend) and in participants with a negative FH of PCa (χ2 = 45.5; P < .001 for trend).,"[{'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Na', 'Affiliation': 'Program for Personalized Cancer Care, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Labbate', 'Affiliation': 'Program for Personalized Cancer Care, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Hongjie', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Program for Personalized Cancer Care, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Zhuqing', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': 'Program for Personalized Cancer Care, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Fantus', 'Affiliation': 'Program for Personalized Cancer Care, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Chi-Hsiung', 'Initials': 'CH', 'LastName': 'Wang', 'Affiliation': 'Program for Personalized Cancer Care, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Gerald L', 'Initials': 'GL', 'LastName': 'Andriole', 'Affiliation': 'Division of Urologic Surgery, Department of Surgery, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Isaacs', 'Affiliation': 'James Buchanan Brady Urological Institute, Department of Urology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'S Lilly', 'Initials': 'SL', 'LastName': 'Zheng', 'Affiliation': 'Program for Personalized Cancer Care, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Helfand', 'Affiliation': 'Program for Personalized Cancer Care, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Program for Personalized Cancer Care, NorthShore University HealthSystem, Evanston, Illinois.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.18145']
1097,31870925,A Prospective Randomized Blinded Trial of Remote Ischemic Preconditioning in Children Undergoing Cardiac Surgery.,"Remote ischemic preconditioning (RIPC) has been proposed as an intervention to protect myocardium and attenuate end-organ dysfunction associated with cardiopulmonary bypass. We investigated the effect of RIPC in children undergoing cardiopulmonary bypass involving clinical outcome, cardiac and end-organ function, inflammatory response, and myocardial gene expression. A prospective, investigator-blinded, randomized, controlled trial was performed. Patients were randomized into RIPC or Control; RIPC consisted of three 5-minute cycles of limb ischemia-reperfusion taking place 1 and 12 hours preoperatively. Clinical outcomes included cardiac function, ICU surveillance, and renal function. In addition, inflammatory markers and myocardial gene expression were evaluated. RIPC patients required shorter ICU stay (days), RIPC: 1.8 (0.94-3.88) vs Control: 4.9 (1.63-7.20), P = 0.029. Echocardiography parameters demonstrated reduced biventricular function following surgery showing no difference between groups. A nonsignificant trend for reduced troponin was observed following RIPC: AUC analysis, RIPC: 393.05 (98.85-1038.73) vs Control: 596.10 (225.38-954.24) P = 0.75. B-type natriuretic peptide and renal function parameters were similar between groups. Postoperative TNF-α was significantly reduced after RIPC, RIPC: 15.42 (7.81-114.86) vs Control: 108.98 (42.28-301.19) P = 0.02. Remaining inflammatory markers demonstrated no significant difference between groups. HSP-60 showed lower myocardial expression following RIPC, RIPC: 3.95 (2.69-6.28) vs Control: 6.83 (4.74-8.81), P = 0.05. Expression of other analyzed genes was not influenced by RIPC. RIPC was associated with shorter ICU stay and reduced TNF-α but did not influence other clinical outcomes, not confer protection against cardiac injury or renal dysfunction. The association between RIPC and ICU stay may be influenced by unaccounted latent variables, including cardiac morphology.",2020,"RIPC was associated with shorter ICU stay and reduced TNF-α but did not influence other clinical outcomes, not confer protection against cardiac injury or renal dysfunction.","['children undergoing CPB involving', 'children undergoing cardiac surgery']","['limb ischemia-reperfusion taking place one and twelve hours pre-operatively', 'RIPC or control; RIPC', 'RIPC', 'Remote ischaemic preconditioning (RIPC', 'Remote Ischaemic Preconditioning']","['cardiac function, ICU surveillance and renal function', 'BNP and renal function parameters', 'reduced Troponin', 'shorter ICU stay', 'clinical outcome, cardiac and end-organ function, inflammatory response and myocardial gene expression', 'shorter ICU stay and reduced TNF-α', 'myocardial expression', 'protection against cardiac injury or renal dysfunction', 'bi-ventricular function', 'inflammatory markers and myocardial gene expression']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}]","[{'cui': 'C2945695', 'cui_str': 'Limb ischemia'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C1709632', 'cui_str': 'Precondition (attribute)'}]","[{'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0523952', 'cui_str': 'Troponin measurement'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0080309', 'cui_str': 'Ventricular Function'}]",,0.337321,"RIPC was associated with shorter ICU stay and reduced TNF-α but did not influence other clinical outcomes, not confer protection against cardiac injury or renal dysfunction.","[{'ForeName': 'Maribel Carolina', 'Initials': 'MC', 'LastName': 'Verdesoto Rodriguez', 'Affiliation': 'University of Glasgow, Glasgow, United Kingdom. Electronic address: maribelcvr@hotmail.com.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Spenceley', 'Affiliation': ""Royal Children's Hospital, Glasgow, United Kingdom.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ilina', 'Affiliation': ""Royal Children's Hospital, Glasgow, United Kingdom.""}, {'ForeName': 'Mark H D', 'Initials': 'MHD', 'LastName': 'Danton', 'Affiliation': ""Royal Children's Hospital, Glasgow, United Kingdom.""}]",Seminars in thoracic and cardiovascular surgery,['10.1053/j.semtcvs.2019.12.004']
1098,30006020,A pilot investigation of the effect of electronic cigarettes on smoking behavior among opioid-dependent smokers.,"INTRODUCTION


Compared to the general population, smoking rates are 2-4 times higher among individuals with opioid use disorders (OUDs). These smokers also have poor long-term cessation rates, even with pharmacotherapy or other interventions. Low success rates with traditional approaches may prompt smokers with OUDs to try more novel products like electronic cigarettes (ECIGs). This pilot study was designed to examine the feasibility, acceptability, and effect of ECIGs on smoking behavior among smokers with OUD.
METHODS


Participants (N = 25) were daily smokers receiving buprenorphine/naloxone for OUD at an outpatient clinic. They were randomized to use a second-generation ECIG (0 or 18 ng/ml nicotine) ad libitum for two weeks while completing assessments via text messaging daily, and also via in-person visits at baseline, end of the two-week intervention, and a 4-week follow-up.
RESULTS


Feasibility was evidenced by high enrollment (93.9%) and retention (70.9%) rates. ECIG adherence was relatively high as measured by self-report (80.6% active, 91.7% placebo), while the average volume of liquid used per week was low (~3 ml). Both ECIG doses produced reductions in self-reported cigarettes per day that were not supported by average carbon monoxide levels. Biologically-confirmed smoking abstinence was observed in 8% of participants.
CONCLUSIONS


Preliminary results suggest that smokers with OUD are interested in using ECIGs, but their adherence may be less than ideal. Poor medication adherence rates are often observed in this disparate population, and future work should consider the use of other ECIG device types and a combination of methods to verify and quantify ECIG use.",2019,Both ECIG doses produced reductions in self-reported cigarettes per day that were not supported by average carbon monoxide levels.,"['Participants (N\u202f=\u202f25) were daily smokers receiving', 'individuals with opioid use disorders (OUDs', 'for OUD at an outpatient clinic', 'smokers with OUD', 'opioid-dependent smokers']","['ECIG', 'second-generation ECIG (0 or 18\u202fng/ml nicotine', 'electronic cigarettes', 'ECIGs', 'buprenorphine/naloxone']","['smoking behavior', 'smoking abstinence', 'ECIG adherence']","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}]","[{'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C1169989', 'cui_str': 'Buprenorphine / Naloxone'}]","[{'cui': 'C1519383', 'cui_str': 'Smoking Behaviors'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]",25.0,0.0423818,Both ECIG doses produced reductions in self-reported cigarettes per day that were not supported by average carbon monoxide levels.,"[{'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Felicione', 'Affiliation': 'West Virginia University, Department of Psychology, United States.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Enlow', 'Affiliation': 'Nemours/Alfred I. DuPont Hospital for Children, Center for Healthcare Delivery Science, United States.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Elswick', 'Affiliation': 'West Virginia University, Department of Behavioral Medicine & Psychiatry, United States.'}, {'ForeName': 'Dustin', 'Initials': 'D', 'LastName': 'Long', 'Affiliation': 'University of Alabama at Birmingham, Department of Biostatistics, United States.'}, {'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Sullivan', 'Affiliation': 'West Virginia University, Department of Behavioral Medicine & Psychiatry, United States.'}, {'ForeName': 'Melissa D', 'Initials': 'MD', 'LastName': 'Blank', 'Affiliation': 'West Virginia University, Department of Psychology, United States. Electronic address: mdblank@mail.wvu.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2018.07.003']
1099,30389200,Impact of messages about scientific uncertainty on risk perceptions and intentions to use electronic vaping products.,"BACKGROUND


The science surrounding e-cigarettes and other electronic vaping products (EVPs) is rapidly evolving, and the health effects of vaping are unclear. Little research has explored how individuals respond to information acknowledging scientific uncertainty. The aim of the present study was to understand the impact of messages about scientific uncertainty regarding the health effects of vaping on risk perceptions and behavioral intentions.
METHODS


Adults in an online experiment (n = 2508) were randomly exposed to view either a control message (a short factual statement about EVPs) or an uncertainty message (the control message plus additional information describing why EVP-related research is limited or inconclusive). Participants rated the risks of vaping and their intentions to try or stop vaping.
RESULTS


Individuals who viewed the uncertainty message rated vaping as less risky than those who viewed the control message. Message exposure did not impact intentions to try vaping soon or intentions to stop vaping in the next 6 months.
CONCLUSIONS


Acknowledging scientific uncertainty made EVP use seem less risky. Future research should explore possible drivers of this response, such as deeper message processing or emotional reactions. Researchers and practitioners designing public health campaigns about vaping might consider a cautious approach to presenting information about scientific uncertainty.",2019,"Message exposure did not impact intentions to try vaping soon or intentions to stop vaping in the next 6 months.
",['Adults in an online experiment (n\u202f=\u202f2508'],['control message (a short factual statement about EVPs) or an uncertainty message (the control message plus additional information describing why EVP-related research is limited or inconclusive'],['risks of vaping and their intentions to try or stop vaping'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0087130', 'cui_str': 'Uncertainty'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0035168'}, {'cui': 'C1629507', 'cui_str': 'Inconclusive'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4083280', 'cui_str': 'Vaping'}]",2508.0,0.0368206,"Message exposure did not impact intentions to try vaping soon or intentions to stop vaping in the next 6 months.
","[{'ForeName': 'Jessica K', 'Initials': 'JK', 'LastName': 'Pepper', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC 27709, USA. Electronic address: jpepper@rti.org.'}, {'ForeName': 'Linda B', 'Initials': 'LB', 'LastName': 'Squiers', 'Affiliation': 'Public Health Research Division, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC 27709, USA.'}, {'ForeName': 'Susana C', 'Initials': 'SC', 'LastName': 'Peinado', 'Affiliation': 'Patient & Family Engagement, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC 27709, USA.'}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'Bann', 'Affiliation': 'Division for Statistical & Data Sciences, 3040 E. Cornwallis Rd., Research Triangle Park, NC 27709, USA.'}, {'ForeName': 'Suzanne D', 'Initials': 'SD', 'LastName': 'Dolina', 'Affiliation': 'Patient & Family Engagement, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC 27709, USA.'}, {'ForeName': 'Molly M', 'Initials': 'MM', 'LastName': 'Lynch', 'Affiliation': 'Patient & Family Engagement, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC 27709, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Nonnemaker', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC 27709, USA.'}, {'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'McCormack', 'Affiliation': 'Public Health Research Division, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC 27709, USA.'}]",Addictive behaviors,['10.1016/j.addbeh.2018.10.025']
1100,31790779,Evaluation of the Unyvero i60 ITI® multiplex PCR for infected chronic leg ulcers diagnosis.,"OBJECTIVES


Unyvero i60 ITI multiplex PCR (mPCR) may identify a large panel of bacteria and antibiotic resistance genes. In this study, we compared results obtained by mPCR to standard bacteriology in chronic leg ulcer (CLU) infections.
METHODS


A prospective study, part of the interventional-blinded randomized study ""ulcerinfecte"" (NCT02889926), was conducted at Saint Joseph Hospital in Paris. Fifty patients with a suspicion of infected CLU were included between February 2017 and September 2018. Conventional bacteriology and mPCR were performed simultaneously on deep skin biopsies.
RESULTS


Staphylococcus aureus and Pseudomonas aeruginosa were the most detected pathogens. Regarding the global sensitivity, mPCR is not overcome to the standard culture. Anaerobes and slow growing bacteria were detected with a higher sensitivity rate by mPCR than standard culture.
CONCLUSION


Unyvero i60 ITI multiplex PCR detected rapidly pathogenic bacteria in infected CLU especially anaerobes and slow growing bacteria and was particularly effective for patients previously treated with antibiotics.",2020,"OBJECTIVES


Unyvero i60 ITI multiplex PCR (mPCR) may identify a large panel of bacteria and antibiotic resistance genes.","['Fifty patients with a suspicion of infected CLU were included between February 2017 and September 2018', 'Saint Joseph Hospital in Paris', 'chronic leg ulcer (CLU) infections', 'infected chronic leg ulcers diagnosis']","['Unyvero i60 ITI® multiplex PCR', 'Conventional bacteriology and mPCR']",['sensitivity rate'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242114', 'cui_str': 'Suspicion'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0242823', 'cui_str': 'Saints'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0331677', 'cui_str': 'Paris (organism)'}, {'cui': 'C0263560', 'cui_str': 'Chronic ulcer of lower extremity'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]","[{'cui': 'C0063763', 'cui_str': 'iodo-tyraminyl inulin'}, {'cui': 'C3179032', 'cui_str': 'Multiplex PCR'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0004644', 'cui_str': 'Bacteriology'}]","[{'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}]",50.0,0.0376389,"OBJECTIVES


Unyvero i60 ITI multiplex PCR (mPCR) may identify a large panel of bacteria and antibiotic resistance genes.","[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Reissier', 'Affiliation': 'Clinical Microbiology Laboratory, Saint-Joseph Hospital, Paris, France. Electronic address: sophie.reissier@gmail.com.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Lazareth', 'Affiliation': 'Vascular Medicine and Phlebology Service, Saint-Joseph Hospital, Paris, France.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Adjiman', 'Affiliation': 'Clinical Microbiology Laboratory, Saint-Joseph Hospital, Paris, France.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Couzigou', 'Affiliation': 'Antimicrobial Stewardship Team, Saint-Joseph Hospital, Paris, France.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Vidal', 'Affiliation': 'Antimicrobial Stewardship Team, Saint-Joseph Hospital, Paris, France.'}, {'ForeName': 'Assaf', 'Initials': 'A', 'LastName': 'Mizrahi', 'Affiliation': 'Clinical Microbiology Laboratory, Saint-Joseph Hospital, Paris, France.'}, {'ForeName': 'Jean Claude', 'Initials': 'JC', 'LastName': 'Nguyen Van', 'Affiliation': 'Clinical Microbiology Laboratory, Saint-Joseph Hospital, Paris, France.'}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Pilmis', 'Affiliation': 'Antimicrobial Stewardship Team, Saint-Joseph Hospital, Paris, France.'}, {'ForeName': 'Alban', 'Initials': 'A', 'LastName': 'Le Monnier', 'Affiliation': 'Clinical Microbiology Laboratory, Saint-Joseph Hospital, Paris, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lourtet-Hascoët', 'Affiliation': 'Clinical Microbiology Laboratory, Saint-Joseph Hospital, Paris, France.'}]",Journal of microbiological methods,['10.1016/j.mimet.2019.105796']
1101,31775831,A manual-based family intervention for families living with the consequences of traumatic injury to the brain or spinal cord: a study protocol of a randomized controlled trial.,"BACKGROUND


Acquiring a traumatic injury constitutes a severe life change for the survivor, but also for the surrounding family. The paradigm of helping the family has primarily been on psychosocial interventions targeting caregivers. However, interventions including both survivor and caregivers should be an essential part of treatment, as the whole family's functional level and mental health can be affected. The current study protocol presents a manualized family intervention for families living with traumatic injury to the brain (TBI) or spinal cord (tSCI). The objectives are to investigate if the intervention improves quality of life (QoL) and decreases burden. It is hypothesized that the family intervention improves problem-solving strategies and family dynamics, which will reduce the burden. This may improve the caregivers' mental health, which will improve the support to the survivor and QoL.
METHODS


The study is an interventional, two-arm, randomized controlled trial. During a 2-year period, a total of 132 families will be included. Participants will be recruited from East-Denmark. Inclusion criteria are (1) TBI or tSCI, (2) ≥ 18 years of age, (3) ≥ 6 months to ≤ 2 years since discharge from hospital, (4) ability to understand and read Danish, (5) cognitive abilities that enable participation, and (6) a minimum of one family member actively involved in the survivor's life. Exclusion criteria are (1) active substance abuse, (2) aphasia, (3) prior neurologic or psychiatric diagnose, and (4) history of violence. Within each disease group, families will be allocated randomly to participate in an intervention or a control group with a ratio 1:1. The intervention groups receive the family intervention consisting of eight sessions of 90 min duration. Families in the control groups receive 2 h of psychoeducation. All participants complete questionnaires on QoL, self-perceived burden, family dynamics, problem-solving strategies, mental health, and resilience at pre-intervention, post-intervention, and 6-month follow up.
CONCLUSION


If the intervention is found to have effect, the study will contribute with novel knowledge on the use of a manual-based intervention including the entire family. This would be of clinical interest and would help families living with the consequences of TBI or tSCI.
TRIALS REGISTRATION


ClinicalTrials.gov, NCT03814876. Retrospectively registered on 24 January 2019.",2019,The current study protocol presents a manualized family intervention for families living with traumatic injury to the brain (TBI) or spinal cord (tSCI).,"['families living with the consequences of traumatic injury to the brain or spinal cord', 'Exclusion criteria are (1) active substance abuse, (2) aphasia, (3) prior neurologic or psychiatric diagnose, and (4) history of violence', '18\u2009years of age, (3) ≥', 'Participants will be recruited from East-Denmark', 'families living with traumatic injury to the brain (TBI) or spinal cord (tSCI']","['manual-based family intervention', 'manualized family intervention']","['quality of life (QoL', 'QoL, self-perceived burden, family dynamics, problem-solving strategies, mental health, and resilience']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0686907', 'cui_str': 'Consequence of (contextual qualifier) (qualifier value)'}, {'cui': 'C3263723', 'cui_str': 'Injuries'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0037925', 'cui_str': 'Myelon'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0740858', 'cui_str': 'Substance Abuse'}, {'cui': 'C0003537', 'cui_str': 'Anepia'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]","[{'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0034380'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015609', 'cui_str': 'Dynamic, Family'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",132.0,0.0585112,The current study protocol presents a manualized family intervention for families living with traumatic injury to the brain (TBI) or spinal cord (tSCI).,"[{'ForeName': 'Pernille Langer', 'Initials': 'PL', 'LastName': 'Soendergaard', 'Affiliation': 'Department of Neurorehabilitation, TBI Unit, Rigshospitalet, Kettegaard Allé 30, 2650, Hvidovre, Denmark. Pernille.langer.soendergaard@regionh.dk.'}, {'ForeName': 'Mia Moth', 'Initials': 'MM', 'LastName': 'Wolffbrandt', 'Affiliation': 'Department of Neurorehabilitation, TBI Unit, Rigshospitalet, Kettegaard Allé 30, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Fin', 'Initials': 'F', 'LastName': 'Biering-Sørensen', 'Affiliation': 'Clinic for Spinal Cord Injuries, Rigshospitalet, University of Copenhagen, Havnevej 25, 3100, Hornbæk, Denmark.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Nordin', 'Affiliation': 'Department of Neurosurgery, Karolinska University Hospital, Eugeniavägen 3, 171 76, Stockholm, Sweden.'}, {'ForeName': 'Trine', 'Initials': 'T', 'LastName': 'Schow', 'Affiliation': 'Research and Development, Brain Injury Center BOMI, Maglegaardsvej 15, 4000, Roskilde, Denmark.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Arango-Lasprilla', 'Affiliation': 'BioCruces Vizcaya Health Research Institute, Cruces University Hospital, Barakaldo, Spain.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Norup', 'Affiliation': 'Department of Neurorehabilitation, TBI Unit, Rigshospitalet, Kettegaard Allé 30, 2650, Hvidovre, Denmark.'}]",Trials,['10.1186/s13063-019-3794-5']
1102,31753032,Eye movement desensitization and reprocessing (EMDR) therapy for posttraumatic stress disorder in adults with serious mental illness within forensic and rehabilitation services: a study protocol for a randomized controlled trial.,"BACKGROUND


Eye movement desensitization and reprocessing (EMDR) is an evidenced-based treatment for posttraumatic stress disorder (PTSD). Forensic mental health services provide assessment and treatment of people with mental illness and a history of criminal offending, or those who are at risk of offending. Forensic mental health services include high, medium, and low-security inpatient settings as well as prison in-reach and community outpatient services. There is a high prevalence of PTSD in forensic settings and posttraumatic experiences can arise in people who violently offend in the context of serious mental illness (SMI). Successful treatment of PTSD may reduce the risk of relapse and improve clinical outcomes for this population. This study aims to assess the efficacy, risk of harm, and acceptability of EMDR within forensic and rehabilitation mental health services, as compared to treatment as usual (routine care).
METHODS


This is a single-blind, randomized controlled trial comparing EMDR therapy to the waiting list (routine care). Adult forensic mental health service users (n = 46) with SMI and meeting the criteria for PTSD will be included in the study. Participants will be randomized after baseline assessment to either treatment as usual plus waiting list for EMDR or to treatment as usual plus EMDR. The EMDR condition comprises nine sessions, around 60 min in length delivered weekly, the first of which is a case conceptualization session. The primary outcomes are clinician and participant-rated symptoms of PTSD, and adverse events. Secondary outcomes include psychotic symptoms, social functioning, level of disability, self-esteem, depressive symptoms, post-trauma cognitions, and broad domains of complex posttraumatic difficulties. A trained assessor blinded to the treatment condition will assess outcomes at baseline, 10 weeks, and 6 months. Additionally, grounded theory qualitative methods will be used to explore participant experience of EMDR for a subset of participants.
DISCUSSION


This study will contribute to the currently limited evidence base for EMDR for PTSD in forensic settings. It is the first randomized clinical trial to assess the efficacy, risk of harm, and acceptability of EMDR for PTSD in people with SMI in either forensic, mental health inpatient, or custodial settings.
TRIAL REGISTRATION


Australia and New Zealand Clinical Trials Network, ACTRN12618000683235. Registered prospectively on 24 April 2018.",2019,"BACKGROUND


Eye movement desensitization and reprocessing (EMDR) is an evidenced-based treatment for posttraumatic stress disorder (PTSD).","['Adult forensic mental health service users (n\u2009=\u200946) with SMI and meeting the criteria for PTSD will be included in the study', 'people with SMI in either forensic, mental health inpatient, or custodial settings', 'people with mental illness and a history of criminal offending, or those who are at risk of offending', 'adults with serious mental illness within forensic and rehabilitation services']","['EMDR', 'Eye movement desensitization and reprocessing (EMDR', 'PTSD', 'Eye movement desensitization and reprocessing (EMDR)\xa0therapy', 'usual plus waiting list for EMDR or to treatment as usual plus EMDR']","['risk of relapse', 'psychotic symptoms, social functioning, level of disability, self-esteem, depressive symptoms, post-trauma cognitions, and broad domains of complex posttraumatic difficulties', 'clinician and participant-rated symptoms of PTSD, and adverse events', 'efficacy, risk of harm, and acceptability of EMDR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025355', 'cui_str': 'Mental Hygiene Services'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C2607966', 'cui_str': 'Criminals'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0587660', 'cui_str': 'Rehabilitation service (qualifier value)'}]","[{'cui': 'C0870535', 'cui_str': 'EMDR'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0556520', 'cui_str': 'Desensitization (Psychology)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0870535', 'cui_str': 'EMDR'}]",,0.221999,"BACKGROUND


Eye movement desensitization and reprocessing (EMDR) is an evidenced-based treatment for posttraumatic stress disorder (PTSD).","[{'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Every-Palmer', 'Affiliation': 'University of Otago, Wellington, New Zealand. susanna.every-palmer@otago.ac.nz.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Flewett', 'Affiliation': 'Capital and Coast District Health Board, Wellington, New Zealand.'}, {'ForeName': 'Shaystah', 'Initials': 'S', 'LastName': 'Dean', 'Affiliation': 'University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Hansby', 'Affiliation': 'University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Atalie', 'Initials': 'A', 'LastName': 'Colman', 'Affiliation': 'University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Weatherall', 'Affiliation': 'University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Bell', 'Affiliation': 'University of Otago, Wellington, New Zealand.'}]",Trials,['10.1186/s13063-019-3760-2']
1103,29660034,E-cigarettes May Support Smokers With High Smoking-Related Risk Awareness to Stop Smoking in the Short Run: Preliminary Results by Randomized Controlled Trial.,"Introduction


E-cigarettes may be positively used in tobacco cessation treatments. However, neither the World Health Organization nor the American Food and Drug Administration has recognized them as effective cessation aids. Data about the efficacy and safety of e-cigarettes are still limited and controversial.
Methods


This was a double-blind randomized controlled study. The main focus of this article is on a secondary outcome of the study, that is, the assessment of effectiveness and safety of e-cigarettes in achieving smoking cessation in a group of chronic smokers voluntarily involved in long-term lung cancer screening. Participants were randomized into three arms with a 1:1:1 ratio: e-cigarettes (Arm 1), placebo (Arm 2), and control (Arm 3). All subjects also received a low-intensity counseling.
Results


Two hundred ten smokers were randomized (70 to nicotine e-cigarettes, 70 nicotine-free placebo e-cigarettes, and 70 to control groups). About 25% of participants who followed a cessation program based on the use of e-cigarettes (Arm 1 and Arm 2) were abstinent after 3 months. Conversely, only about 10% of smokers in Arm 3 stopped. A Kruskal-Wallis test showed significant differences in daily cigarettes smoking across the three arms (K-W = 6.277, p = .043). In particular, participants in Arm 1 reported a higher reduction rate (M = -11.6441, SD = 7.574) than participants in Arm 2 (M = -10.7636, SD = 8.156) and Arm 3 (M = -9.1379, SD = 8.8127).
Conclusions


Our findings support the efficacy and safety of e-cigarettes in a short-term period. E-cigarettes use led to a higher cessation rate. Furthermore, although all participants reported a significant reduction of daily cigarette consumption compared to the baseline, the use of e-cigarettes (including those without nicotine) allowed smokers to achieve better results.
Implications


E-cigarettes increased the stopping rate as well as the reduction of daily cigarettes in participants who continued smoking. In fact, although all participants reported a significant reduction of tobacco consumption compared to the baseline, the use of e-cigarettes allowed smokers to achieve a better result. It could be worthwhile to associate this device with new ICT-driven models of self-management support in order to enable people to better handle behavioral changes and side effects. This is true for ready-to-quit smokers (such as our participants) but can also be advantageous for less motivated smokers engaged in clinical settings.",2019,"A Kruskal-Wallis test showed significant differences in daily cigarettes smoking across the three arms (K-W = 6.277, p = .043).","['participants who continued smoking', 'Two hundred ten smokers were randomized (70 to']","['placebo', 'e-cigarettes', 'nicotine e-cigarettes, 70 nicotine-free placebo e-cigarettes', 'E-cigarettes May Support Smokers', 'low-intensity counseling']","['efficacy and safety of e-cigarettes', 'higher reduction rate', 'daily cigarettes smoking', 'daily cigarette consumption', 'tobacco consumption']","[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0700219', 'cui_str': 'Cigarette Smoking'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption (observable entity)'}, {'cui': 'C0543414', 'cui_str': 'Tobacco Chewing'}]",210.0,0.0643415,"A Kruskal-Wallis test showed significant differences in daily cigarettes smoking across the three arms (K-W = 6.277, p = .043).","[{'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Masiero', 'Affiliation': 'Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Lucchiari', 'Affiliation': 'Department of Philosophy, University of Milan, Milan, Italy.'}, {'ForeName': 'Ketti', 'Initials': 'K', 'LastName': 'Mazzocco', 'Affiliation': 'Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Veronesi', 'Affiliation': 'Humanitas Research Hospital, Division of Thoracic and General Surgery, Milan, Italy.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Maisonneuve', 'Affiliation': 'European Institute of Oncology, Division of Epidemiology and Biostatistics, Milan, Italy.'}, {'ForeName': 'Costantino', 'Initials': 'C', 'LastName': 'Jemos', 'Affiliation': 'European Institute of Oncology, Division of Pharmacy, Milan, Italy.'}, {'ForeName': 'Emanuela Omodeo', 'Initials': 'EO', 'LastName': 'Salè', 'Affiliation': 'European Institute of Oncology, Division of Pharmacy, Milan, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Spina', 'Affiliation': 'Humanitas Research Hospital, Division of Thoracic and General Surgery, Milan, Italy.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Bertolotti', 'Affiliation': 'Division of Thoracic Surgery, European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Pravettoni', 'Affiliation': 'Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/nty047']
1104,31587885,The Influence of Adding Diphenhydramine Before Initiation of Moderate Sedation with Midazolam and Pethidine for Improving Quality of Colonoscopy.,"BACKGROUND


Combination of Intravenous benzodiazepines with opiates appears to be essential in order to guarantee high quality of moderate sedation during colonoscopy. Diphenhydramine is recommended for endoscopic procedures in difficult-to-sedate patients However, the studies supporting its use have yielded conflicting results.
OBJECTIVE


To assess the value of adding diphenhydramine hydrochloride before initiation of moderate sedation with midazolam and pethidine for Improving Quality of Sedation during colonoscopy.
METHODS


We conducted a prospective, randomized, double-blind, placebo-controlled study of 150 Patients undergoing diagnostic colonoscopy. Of 150 patients, data were analyzed for 100 patients randomized into two groups: Diphenhydramine group (n = 53) received 50 mg of diphenhydramine intravenously before initiation of moderate sedation with pethidine and midazolam while in placebo group (n = 47) received placebo in addition to pethidine and midazolam. Amount of pethidine and midazolam used and Quality of sedation were assessed.
RESULTS


The mean doses of pethidine was significantly higher in placebo group as compared to diphenhydramine group (69.9 ± 35.4 mg vs 61.2 ± 21.0 mg, p < 0.01) However, no significant difference between the two groups regarding midazolam mean dose (4.9.±2.1 mg vs 4.8 ± 2.0 mg,p = 0.786). More patients in diphenhydramine group were being very satisfied with the procedure as compared to those in placebo group (88.67% vs 59.57%,p < 0.001).Furthermore more endoscopist in diphenhydramine group were being very satisfied with the procedure as compared to those in placebo group (77.35% vs 51.06%,p < 0.001).
CONCLUSIONS


Intravenous diphenhydramine hydrochloride given before initiation of midazolam and pethidine offers a significant Improvement of Quality of moderate Sedation during colonoscopy without increasing the number of sedation related complications.",2019,"More patients in diphenhydramine group were being very satisfied with the procedure as compared to those in placebo group (88.67% vs 59.57%,p < 0.001).Furthermore more endoscopist in diphenhydramine group were being very satisfied with the procedure as compared to those in placebo group (77.35% vs 51.06%,p < 0.001).
","['sedate patients', '150 Patients undergoing diagnostic colonoscopy', '150 patients, data were analyzed for 100 patients randomized into two groups']","['midazolam', 'benzodiazepines', 'Midazolam and Pethidine', 'placebo', 'diphenhydramine hydrochloride', 'diphenhydramine', 'pethidine and midazolam', '50\xa0mg of diphenhydramine', 'Diphenhydramine', 'midazolam and pethidine']","['mean doses of pethidine', 'Quality of Sedation', 'Quality of moderate Sedation', 'Quality of Colonoscopy', 'Quality of sedation']","[{'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0400018', 'cui_str': 'Diagnostic endoscopic examination on colon (procedure)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0025376', 'cui_str': 'pethidine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004963', 'cui_str': 'Diphenhydramine Hydrochloride'}, {'cui': 'C0012522', 'cui_str': 'Diphenhydramine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0025376', 'cui_str': 'pethidine'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0079159', 'cui_str': 'Sedation, Moderate'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]",150.0,0.11947,"More patients in diphenhydramine group were being very satisfied with the procedure as compared to those in placebo group (88.67% vs 59.57%,p < 0.001).Furthermore more endoscopist in diphenhydramine group were being very satisfied with the procedure as compared to those in placebo group (77.35% vs 51.06%,p < 0.001).
","[{'ForeName': 'Mohamed S', 'Initials': 'MS', 'LastName': 'El Shahawy', 'Affiliation': 'Department of Internal Medicine, Gastroenterology Unit, Faculty of Medicine, AL-Azhar University, Cairo, Egypt. Electronic address: tep_alshahawy@yahoo.com.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'El-Fayoumy', 'Affiliation': 'Department of Internal Medicine, Gastroenterology Unit, Faculty of Medicine, AL-Azhar University, Cairo, Egypt.'}]",Journal of the National Medical Association,['10.1016/j.jnma.2019.09.001']
1105,30557916,"Efficacy of novel β 3  -adrenoreceptor agonist vibegron on nocturia in patients with overactive bladder: A post-hoc analysis of a randomized, double-blind, placebo-controlled phase 3 study.","OBJECTIVES


To investigate the efficacy of vibegron on nocturia in patients with overactive bladder.
METHODS


Among the Japanese overactive bladder patients enrolled in the placebo-controlled, multicenter, randomized, double-blind phase 3 study of vibegron, a total of 669 patients with nocturia (≥1 nocturnal void) were included. Changes from baseline in micturition parameters were compared for vibegron treatment (50 and 100 mg/day) versus placebo. Correlations of hours of undisturbed sleep with the frequency of nocturnal voiding and the volume of the first nocturnal voiding were examined. Demographics and baseline characteristics contributing to reduction in the frequency of nocturnal voiding were also analyzed.
RESULTS


At week 12, the frequency of nocturnal voiding was reduced from baseline by 0.74 and 0.78, respectively, for the vibegron 50 and 100 mg groups; the reductions were significant when compared with the placebo group (P < 0.05 and P < 0.001, respectively). The mean volume of nocturnal voids and the volume of the first nocturnal voiding were significantly greater in the vibegron groups than in the placebo group. The vibegron groups showed significant correlations of hours of undisturbed sleep with the changes in the frequency of nocturnal voiding and in the volume of the first nocturnal voiding. Vibegron treatment, no previous treatment with anticholinergics, ≥12 voids per day and hours of undisturbed sleep <180 min significantly contributed to a reduction in the frequency of nocturnal voiding.
CONCLUSIONS


Vibegron is a useful therapeutic option for improving nocturia in patients with overactive bladder.",2019,The mean volume of nocturnal voids and the volume of the first nocturnal voiding were significantly greater in the vibegron groups than in the placebo group.,"['Japanese overactive bladder patients enrolled in the', '669 patients with nocturia (≥1 nocturnal void) were included', 'patients with overactive bladder']","['vibegron', 'placebo', 'novel β 3  -adrenoreceptor agonist vibegron']","['nocturnal voiding and the volume of the first nocturnal voiding', 'mean volume of nocturnal voids and the volume of the first nocturnal voiding', 'nocturia', 'frequency of nocturnal voiding']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028734', 'cui_str': 'Nycturia'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C4279743', 'cui_str': 'vibegron'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0028734', 'cui_str': 'Nycturia'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",669.0,0.150104,The mean volume of nocturnal voids and the volume of the first nocturnal voiding were significantly greater in the vibegron groups than in the placebo group.,"[{'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Yoshida', 'Affiliation': 'Department of Urology, National Centre for Geriatrics and Gerontology, Obu, Aichi, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Takeda', 'Affiliation': 'Department of Urology, Graduate School of Medical Sciences, University of Yamanashi, Kofu, Yamanashi, Japan.'}, {'ForeName': 'Momokazu', 'Initials': 'M', 'LastName': 'Gotoh', 'Affiliation': 'Department of Urology, Nagoya University Graduate School of Medicine, Nagoya, Aichi, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Yokoyama', 'Affiliation': 'Department of Urology, Faculty of Medical Science, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Hidehiro', 'Initials': 'H', 'LastName': 'Kakizaki', 'Affiliation': 'Department of Renal and Urologic Surgery, Asahikawa Medical University, Asahikawa, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Takahashi', 'Affiliation': 'Department of Urology, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Masumori', 'Affiliation': 'Department of Urology, School of Medicine, Sapporo Medical University, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Nagai', 'Affiliation': 'Kyorin Pharmaceutical, Tokyo, Japan.'}, {'ForeName': 'Keita', 'Initials': 'K', 'LastName': 'Hashimoto', 'Affiliation': 'Kyorin Pharmaceutical, Tokyo, Japan.'}, {'ForeName': 'Kazuyoshi', 'Initials': 'K', 'LastName': 'Minemura', 'Affiliation': 'Kyorin Pharmaceutical, Tokyo, Japan.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.13877']
1106,31583962,Optimal Cerebral Perfusion Pressure: Targeted Treatment for Severe Traumatic Brain Injury.,"Identification of individual therapy targets is critical for traumatic brain injury (TBI) patients. Clinical outcomes depend on cerebrovascular autoregulation (CA) impairment. Here, we compare the effectiveness of optimal cerebral perfusion pressure (CPPopt)-targeted therapy in younger (<45 years of age) and elderly (≥45 years of age) TBI patients. Single-center multi-modal invasive arterial blood pressure(t), intracranial pressure (ICP)(t), cerebral perfusion pressure CPP(t), and CPPopt(t) monitoring ( n  = 81) was performed. ICM+ software was used for continuous CPPopt(t) status assessment by identification of pressure reactivity index (PRx). The most significant prognostic factors were age, Glasgow Coma Scale, serum glucose, and duration of longest CA ompairment event (LCAI) when PRx(t) >0.5 within 24 h after admission. The modeled accuracies for favorable and unfavorable outcome prediction were 86.5% and 90.9%, respectively. Age above 45 years and averaged ICP during all monitoring time above 21.3 mm Hg was associated with unfavorable outcome of an individual patient. Averaged CPP values close to CPPopt were associated with a better outcome in younger patients. Averaged ΔCPPopt <-5.0 mm Hg, averaged PRx >0.36, and LCAI >100 min were significantly associated with mortality for the younger patients. The critical values of averaged PRx >0.26 and LCAI >61 min were significantly associated with mortality for the elderly group. Autoregulation-guided treatment was important for individual TBI management, especially in younger patients. Further randomized multi-center studies are needed to prove final benefit.",2020,The critical values of averaged PRx > 0.26 and LCAI > 61 min were significantly associated with mortality for the elderly group.,"['traumatic brain injury (TBI) patients', 'younger (< 45 years-old) and elderly (≥ 45-years-old) TBI patients', 'younger patients', 'severe traumatic brain injury']",['optimal cerebral perfusion pressure- (CPPopt) targeted therapy'],"['cerebrovascular autoregulation (CA) impairment', 'Pressure Reactivity Index (PRx', 'GCS, serum glucose, , and duration of Longest CA Impairment event (LCAI']","[{'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]","[{'cui': 'C0428713', 'cui_str': 'Cerebral Perfusion Pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum (procedure)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",,0.022981,The critical values of averaged PRx > 0.26 and LCAI > 61 min were significantly associated with mortality for the elderly group.,"[{'ForeName': 'Vytautas', 'Initials': 'V', 'LastName': 'Petkus', 'Affiliation': 'Health Telematics Science Institute, Kaunas University of Technology, Kaunas, Lithuania.'}, {'ForeName': 'Aidanas', 'Initials': 'A', 'LastName': 'Preiksaitis', 'Affiliation': 'Health Telematics Science Institute, Kaunas University of Technology, Kaunas, Lithuania.'}, {'ForeName': 'Edvinas', 'Initials': 'E', 'LastName': 'Chaleckas', 'Affiliation': 'Health Telematics Science Institute, Kaunas University of Technology, Kaunas, Lithuania.'}, {'ForeName': 'Romanas', 'Initials': 'R', 'LastName': 'Chomskis', 'Affiliation': 'Health Telematics Science Institute, Kaunas University of Technology, Kaunas, Lithuania.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Zubaviciute', 'Affiliation': 'Clinic of Neurology and Neurosurgery, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Saulius', 'Initials': 'S', 'LastName': 'Vosylius', 'Affiliation': 'Clinic of Neurology and Neurosurgery, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Saulius', 'Initials': 'S', 'LastName': 'Rocka', 'Affiliation': 'Clinic of Neurology and Neurosurgery, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Daiva', 'Initials': 'D', 'LastName': 'Rastenyte', 'Affiliation': 'Department of Neurology, Academy of Medicine, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Marcel J', 'Initials': 'MJ', 'LastName': 'Aries', 'Affiliation': 'Department of Intensive Care, University of Maastricht Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Arminas', 'Initials': 'A', 'LastName': 'Ragauskas', 'Affiliation': 'Health Telematics Science Institute, Kaunas University of Technology, Kaunas, Lithuania.'}, {'ForeName': 'Jan-Oliver', 'Initials': 'JO', 'LastName': 'Neumann', 'Affiliation': 'Department of Neurosurgery, University Hospital Heidelberg, Heidelberg, Germany.'}]",Journal of neurotrauma,['10.1089/neu.2019.6551']
1107,31752978,Reduction of the long-term use of proton pump inhibitors by a patient-oriented electronic decision support tool (arriba-PPI): study protocol for a randomized controlled trial.,"BACKGROUND


Proton pump inhibitors (PPIs) are increasingly being prescribed, although long-term use is associated with multiple side effects. Therefore, an electronic decision support tool with the aim of reducing the long-term use of PPIs in a shared decision-making process between general practitioners (GPs) and their patients has been developed. The developed tool is a module that can be added to the so-called arriba decision support tool, which is already used by GPs in Germany in routine care. In this large-scale cluster-randomized controlled trial we evaluate the effectiveness of this arriba-PPI tool.
METHODS


The arriba-PPI tool is an electronic decision support system that supports shared decision-making and evidence-based decisions around the long-term use of PPIs at the point of care. The tool will be evaluated in a cluster-randomized controlled trial involving 210 GP practices and 3150 patients in Germany. GP practices will be asked to recruit 20 patients aged ≥ 18 years regularly taking PPIs for ≥ 6 months. After completion of patient recruitment, each GP practice with enrolled patients will be cluster-randomized. Intervention GP practices will get access to the software arriba-PPI, whereas control GPs will treat their patients as usual. After an observation period of six months, GP practices will be compared regarding the reduction of cumulated defined daily doses of PPI prescriptions per patient.
DISCUSSION


Our principal hypothesis is that the application of the arriba-PPI tool can reduce PPI prescribing in primary care by at least 15% compared to conventional strategies used by GPs. A positive result implies the implementation of the arriba-PPI tool in routine care.
TRIAL REGISTRATION


German Clinical Trials Register, DRKS00016364. Registered on 31 January 2019.",2019,The arriba-PPI tool is an electronic decision support system that supports shared decision-making and evidence-based decisions around the long-term use of PPIs at the point of care.,"['20 patients aged ≥\u200918\u2009years regularly taking PPIs for ≥\u20096\u2009months', '210 GP practices and 3150 patients in Germany']","['Proton pump inhibitors (PPIs', 'proton pump inhibitors', 'arriba-PPI tool']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]",[],210.0,0.154209,The arriba-PPI tool is an electronic decision support system that supports shared decision-making and evidence-based decisions around the long-term use of PPIs at the point of care.,"[{'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Rieckert', 'Affiliation': 'Institute of General Practice and Family Medicine, Faculty of Health, Witten/Herdecke University, Alfred-Herrhausen-Str. 50, 58448, Witten, Germany. Anja.Rieckert@uni-wh.de.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Becker', 'Affiliation': 'Department of General Medicine, Preventive and Rehabilitation Medicine, University of Marburg, Karl-von-Frisch Str. 4, 35043, Marburg, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Donner-Banzhof', 'Affiliation': 'Department of General Medicine, Preventive and Rehabilitation Medicine, University of Marburg, Karl-von-Frisch Str. 4, 35043, Marburg, Germany.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Viniol', 'Affiliation': 'Department of General Medicine, Preventive and Rehabilitation Medicine, University of Marburg, Karl-von-Frisch Str. 4, 35043, Marburg, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Bücker', 'Affiliation': 'Institute of General Practice, Centre for Health and Society, Medical Faculty, Heinrich-Heine-University Düsseldorf, Moorenstr. 5, 40225, Düsseldorf, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Wilm', 'Affiliation': 'Institute of General Practice, Centre for Health and Society, Medical Faculty, Heinrich-Heine-University Düsseldorf, Moorenstr. 5, 40225, Düsseldorf, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Sönnichsen', 'Affiliation': 'Department of General Practice and Family Medicine, Center for Public Health, Medical University of Vienna, Kinderspitalgasse 15/I, 1090, Vienna, Austria.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Barzel', 'Affiliation': 'Institute of General Practice and Family Medicine, Faculty of Health, Witten/Herdecke University, Alfred-Herrhausen-Str. 50, 58448, Witten, Germany.'}]",Trials,['10.1186/s13063-019-3728-2']
1108,31752981,Radiotherapy versus radiotherapy combined with temozolomide in high-risk low-grade gliomas after surgery: study protocol for a randomized controlled clinical trial.,"BACKGROUND


It has been reported that radiation therapy (RT) followed by procarbazine, lomustine, and vincristine (PCV) chemotherapy could improve progression-free survival (PFS) and overall survival (OS) in patients with high-risk World Health Organization (WHO) grade 2 gliomas after surgery. However, procarbazine is not available in China. In clinical practice, Chinese doctors often use radiotherapy combined with temozolomide (TMZ) to treat these patients, although large-scale prospective studies are lacking. This trial aims to confirm whether RT combined with temozolomide can improve PFS and OS in high-risk patients with low-grade gliomas (LGGs).
METHODS/DESIGN


This is a two-group, randomized controlled trial (RCT) enrolling patients who have LGGs (WHO grade 2) and are aged 40 years or older without regard to the extent of resection or are aged younger than 40 years old with subtotal resection or biopsy. An estimated 250 patients will be enrolled. Eligible participants will be randomly assigned to receive RT alone or RT plus TMZ chemotherapy in a 1:1 ratio. The same RT will be given to all eligible participants regardless of whether they are randomly assigned to the RT group or the chemoradiotherapy (CRT) group. While in the CRT group, patients will receive adjuvant TMZ with or without concurrent radiochemotherapy. The primary outcome of this trial is PFS, and it will be analyzed by the intention-to-treat approach. Secondary outcomes include OS, adverse events, and cognitive function.
DISCUSSION


The objective of our research is to assess the effect of radiotherapy coupled with TMZ in high-risk patients with LGGs after surgery, compared with RT alone. Different histological types and molecular subtypes will be examined, and a corresponding subgroup analysis will be conducted. Our data can provide evidence for postoperative adjuvant therapy in patients with high-risk LGGs in China.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR1800015199. Registered on 13 March 2018.",2019,The same RT will be given to all eligible participants regardless of whether they are randomly assigned to the RT group or the chemoradiotherapy (CRT) group.,"['patients who have LGGs (WHO grade 2) and are aged 40\u2009years or older without regard to the extent of resection or are aged younger than 40\u2009years old with subtotal resection or biopsy', 'high-risk patients with low-grade gliomas (LGGs', '250 patients will be enrolled', 'patients with high-risk World Health Organization (WHO) grade 2 gliomas after surgery', 'Eligible participants', 'patients with high-risk LGGs in China', 'high-risk patients with LGGs after surgery, compared with RT alone', 'high-risk low-grade gliomas after surgery']","['adjuvant TMZ with or without concurrent radiochemotherapy', 'RT combined with temozolomide', 'RT alone or RT plus TMZ chemotherapy', 'procarbazine', 'radiotherapy combined with temozolomide (TMZ', 'chemoradiotherapy (CRT', 'TMZ', 'radiation therapy (RT) followed by procarbazine, lomustine, and vincristine (PCV) chemotherapy', 'radiotherapy', 'Radiotherapy versus radiotherapy combined with temozolomide']","['OS, adverse events, and cognitive function', 'PFS and OS', 'progression-free survival (PFS) and overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0449276', 'cui_str': 'Extent of resection (attribute)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0728939', 'cui_str': 'Subtotal (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0033223', 'cui_str': 'Procarbazine'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0023972', 'cui_str': 'Lomustine'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",250.0,0.333183,The same RT will be given to all eligible participants regardless of whether they are randomly assigned to the RT group or the chemoradiotherapy (CRT) group.,"[{'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Biotherapy, Cancer Center, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Geriatrics Center, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Biotherapy, Cancer Center, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Guan', 'Affiliation': 'Department of Biotherapy, Cancer Center, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'He', 'Affiliation': 'Department of Biotherapy, Cancer Center, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Mu', 'Affiliation': 'Department of Biotherapy, Cancer Center, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan, China.'}, {'ForeName': 'Xingchen', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': 'Department of Biotherapy, Cancer Center, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan, China. pxx2014@scu.edu.cn.'}]",Trials,['10.1186/s13063-019-3741-5']
1109,31753004,"Promoting mental health and wellbeing in schools: examining Mindfulness, Relaxation and Strategies for Safety and Wellbeing in English primary and secondary schools: study protocol for a multi-school, cluster randomised controlled trial (INSPIRE).","BACKGROUND


There are increasing rates of internalising difficulties, particularly anxiety and depression, being reported in children and young people in England. School-based, universal prevention programmes are thought to be one way of helping tackle such difficulties. This protocol describes a four-arm cluster randomised controlled trial, investigating the effectiveness of three different interventions when compared to usual provision, in English primary and secondary pupils. The primary outcome for Mindfulness and Relaxation interventions is a measure of internalising difficulties, while Strategies for Safety and Wellbeing will be examined in relation to intended help-seeking. In addition to the effectiveness analysis, a process and implementation evaluation and a cost-effectiveness evaluation will be undertaken.
METHODS AND ANALYSIS


Overall, 160 primary schools and 64 secondary schools will be recruited across England. This corresponds to 17,600 participants. Measures will be collected online at baseline, 3-6 months later, and 9-12 months after the commencement of the intervention. An economic evaluation will assess the cost-effectiveness of the interventions. Moreover, a process and implementation evaluation (including a qualitative research component) will explore several aspects of implementation (fidelity, quality, dosage, reach, participant responsiveness, adaptations), social validity (acceptability, appropriateness and feasibility), and their moderating effects on the outcomes of interest, and perceived impact.
DISCUSSION


This trial aims to address important questions about whether schools' practices around the promotion of mental wellbeing and the prevention of mental health problems can: (1) be formalised into feasible and effective models of school-based support and (2) whether these practices and their effects can be sustained over time. Given the focus of these interventions on mirroring popular practice in schools and on prioritising approaches that present low-burden, high-acceptability to schools, if proved effective, and cost-effective, the findings will indicate models that are not only empirically tested but also offer high potential for widespread use and, therefore, potentially widespread benefits beyond the life of the trial.
TRIAL REGISTRATION


ISRCTN16386254. Registered on 30 August 2018.",2019,"The primary outcome for Mindfulness and Relaxation interventions is a measure of internalising difficulties, while Strategies for Safety and Wellbeing will be examined in relation to intended help-seeking.","['160 primary schools and 64 secondary schools will be recruited across England', 'English primary and secondary pupils', 'children and young people in England', 'schools', '17,600 participants']",['Mindfulness and Relaxation interventions'],"['implementation (fidelity, quality, dosage, reach, participant responsiveness, adaptations), social validity (acceptability, appropriateness and feasibility', 'internalising difficulties, while Strategies for Safety and Wellbeing will be examined in relation to intended help-seeking']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0036530', 'cui_str': 'Schools, Secondary'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",160.0,0.097181,"The primary outcome for Mindfulness and Relaxation interventions is a measure of internalising difficulties, while Strategies for Safety and Wellbeing will be examined in relation to intended help-seeking.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hayes', 'Affiliation': 'Evidence Based Practice Unit (EBPU), University College London and Anna Freud National Centre for Children and Families (AFNCCF), The Kantor Centre of Excellence, 4-8 Rodney Street, London, N1 9JH, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Moore', 'Affiliation': 'Evidence Based Practice Unit (EBPU), University College London and Anna Freud National Centre for Children and Families (AFNCCF), The Kantor Centre of Excellence, 4-8 Rodney Street, London, N1 9JH, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Stapley', 'Affiliation': 'Evidence Based Practice Unit (EBPU), University College London and Anna Freud National Centre for Children and Families (AFNCCF), The Kantor Centre of Excellence, 4-8 Rodney Street, London, N1 9JH, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Humphrey', 'Affiliation': 'Manchester Institute of Education, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Mansfield', 'Affiliation': 'Manchester Institute of Education, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Joao', 'Initials': 'J', 'LastName': 'Santos', 'Affiliation': 'Manchester Institute of Education, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Ashworth', 'Affiliation': 'Manchester Institute of Education, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Praveetha', 'Initials': 'P', 'LastName': 'Patalay', 'Affiliation': 'MRC Unit for Lifelong Health and Ageing and the Centre for Longitudinal Studies, University College London, London, UK.'}, {'ForeName': 'Eva-Maria', 'Initials': 'EM', 'LastName': 'Bonin', 'Affiliation': 'Care Policy and Evaluation Centre (CPEC), London School of Economics and Political Science, London, UK.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Moltrecht', 'Affiliation': 'Evidence Based Practice Unit (EBPU), University College London and Anna Freud National Centre for Children and Families (AFNCCF), The Kantor Centre of Excellence, 4-8 Rodney Street, London, N1 9JH, UK.'}, {'ForeName': 'Jan R', 'Initials': 'JR', 'LastName': 'Boehnke', 'Affiliation': 'School of Nursing and Health Sciences (SNHS) and the Dundee Centre for Health and Related Research (DCHARR), University of Dundee, Dundee, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Deighton', 'Affiliation': 'Evidence Based Practice Unit (EBPU), University College London and Anna Freud National Centre for Children and Families (AFNCCF), The Kantor Centre of Excellence, 4-8 Rodney Street, London, N1 9JH, UK. EBPU@annafreud.org.'}]",Trials,['10.1186/s13063-019-3762-0']
1110,31812934,The effect of early and systematic integration of palliative care in oncology on quality of life and health care use near the end of life: A randomised controlled trial.,"PURPOSE


This study evaluated the effect of early integrated palliative care (PC) in oncology on quality of life (QOL) near the end of life and use of health care resources near the end of life.
METHOD


Patients with advanced cancer and a life expectancy of approximately 1 year were randomly assigned to either early and systematic integration of PC into oncological care (intervention) or standard oncological care alone (control). QOL was assessed with the EORTC QLQ-C30 global health status/QOL scale and McGill Quality of Life (MQOL) Single Item Scale and Summary Scale at baseline, 12 weeks and 6 weekly thereafter until death. Use of health care resources was collected from chart review in patient's electronic medical file for patients who died while participating in the study.
RESULTS


Of the 186 randomised patients, 185 participants had a baseline measurement and were analysed. By November 2017, 128 patients had died while participating in the study. When applying the terminal decline model, patients in the intervention group scored significantly higher on global health status/QOL of the EORTC QLQ C30, at 6 months (difference: 5.9 [0.06; 11.1], p = 0.03), 3 (difference: 6.8 [1.0; 12.6], p = 0.02), and 1 month (difference: 7.6 [0.7; 14.5], p = 0.03) prior to the patient's death compared to the control group. Similar results were found for the Single Item Scale and Summary Score of the MQOL. We did not observe differences in use of health care resources between groups.
DISCUSSION


Early integrated palliative care in oncology is a valuable approach since it also increases QOL near the end of life and not only soon after initiation of PC.",2020,"When applying the terminal decline model, patients in the intervention group scored significantly higher on global health status/QOL of the EORTC QLQ C30, at 6 months (difference: 5.9 [0.06; 11.1], p = 0.03), 3 (difference: 6.8 [1.0; 12.6], p = 0.02), and 1 month (difference: 7.6 [0.7; 14.5], p = 0.03) prior to the patient's death compared to the control group.","['186 randomised patients', '185 participants had a baseline measurement and were analysed', '128 patients had died while participating in the study', ""patient's electronic medical file for patients who died while participating in the study"", 'Patients with advanced cancer and a life expectancy of approximately 1 year']","['PC into oncological care (intervention) or standard oncological care alone (control', 'early integrated palliative care (PC']","['QOL', 'global health status/QOL of the EORTC QLQ C30', 'EORTC QLQ-C30 global health status/QOL scale and McGill Quality of Life (MQOL', 'Single Item Scale and Summary Score of the MQOL', 'quality of life and health care', 'quality of life (QOL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0180853', 'cui_str': 'File, device (physical object)'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}]","[{'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0034380'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}]",185.0,0.0883458,"When applying the terminal decline model, patients in the intervention group scored significantly higher on global health status/QOL of the EORTC QLQ C30, at 6 months (difference: 5.9 [0.06; 11.1], p = 0.03), 3 (difference: 6.8 [1.0; 12.6], p = 0.02), and 1 month (difference: 7.6 [0.7; 14.5], p = 0.03) prior to the patient's death compared to the control group.","[{'ForeName': 'Gaëlle', 'Initials': 'G', 'LastName': 'Vanbutsele', 'Affiliation': 'End-of-Life Care Research Group, Vrije Universiteit Brussel & Ghent University, Belgium; Department of Internal Medicine and Pediatrics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium; Department of Hematology, Ghent University Hospital, Ghent, Belgium. Electronic address: gaelle.vanbutsele@uzgent.be.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Van Belle', 'Affiliation': 'Department of Internal Medicine and Pediatrics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium; Department of Medical Oncology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Surmont', 'Affiliation': 'Department of Internal Medicine and Pediatrics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium; Department of Respiratory Medicine/Thoracic Oncology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'De Laat', 'Affiliation': 'Palliative Care Team, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Roos', 'Initials': 'R', 'LastName': 'Colman', 'Affiliation': 'Biostatistics Unit, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Eecloo', 'Affiliation': 'End-of-Life Care Research Group, Vrije Universiteit Brussel & Ghent University, Belgium; Department of Internal Medicine and Pediatrics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Naert', 'Affiliation': 'Department of Medical Oncology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'De Man', 'Affiliation': 'Department of Gastroenterology, Division of Digestive Oncology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Geboes', 'Affiliation': 'Department of Internal Medicine and Pediatrics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium; Department of Gastroenterology, Division of Digestive Oncology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Deliens', 'Affiliation': 'End-of-Life Care Research Group, Vrije Universiteit Brussel & Ghent University, Belgium.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Pardon', 'Affiliation': 'End-of-Life Care Research Group, Vrije Universiteit Brussel & Ghent University, Belgium.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.11.009']
1111,31785463,Randomised phase II trial of trofosfamide vs. doxorubicin in elderly patients with untreated metastatic soft-tissue sarcoma.,"Doxorubicin represents the standard first-line treatment for metastatic soft-tissue sarcoma. We assessed the efficacy and safety of trofosfamide in elderly patients. In this controlled phase II trial, we randomly (1:2) assigned 120 previously untreated patients with soft-tissue sarcoma, older than 60 years, with an Eastern Cooperative Oncology Group score of 0-2, to receive either doxorubicin for 6 cycles (arm A) or oral trofosfamide (arm B). The primary end-point was a 6-month progression-free rate (PFR) in the experimental arm (clinical trial information: NCT00204568). Between August 2004 and October 2012, forty and 80 patients were randomly assigned to arm A and arm B, respectively, in 16 centres. The median age was 70 years (range, 60-89). The primary study end-point (6-month PFR) was exceeded, with 27.6% in arm B (95% confidence interval [CI], 18.0-39.1) and 35.9% in arm A: (95% CI, 21.2-52.8). Survival data in terms of progression-free survival were 4.3 months (95% CI, 2.2-6.3) and 2.8 months (95% CI, 1.7-3.6) and in terms of overall survival were 9.8 months (95% CI, 6.7-11.6) and 12.3 months (95% CI, 9.6-16.2), respectively. The number of serious adverse event (SAE) was 59% in arm A and 30.3% in arm B (p = 0.005). Trofosfamide caused more often dyspnoea and low-grade fatigue, whereas with doxorubicin, more often leukocytopenia, neutropenia and mucositis were seen. Discontinuation rates for reasons other than disease progression were 15.4% (arm A) vs. 7.9% (arm B). In an elderly population of patients, oral trofosfamide achieved the estimated primary end-point 6-month PFR and was associated with a favourable toxicity profile compared with doxorubicin.",2020,The number of serious adverse event (SAE) was 59% in arm A and 30.3% in arm B (p = 0.005).,"['The median age was 70 years (range, 60-89', 'elderly patients with untreated metastatic soft-tissue sarcoma', '120 previously untreated patients with soft-tissue sarcoma, older than 60 years, with an Eastern Cooperative Oncology Group score of 0-2, to receive either', 'metastatic soft-tissue sarcoma', 'elderly patients', 'Between August 2004 and October 2012, forty and 80 patients']","['doxorubicin for 6 cycles (arm A) or oral trofosfamide', 'trofosfamide vs. doxorubicin', 'trofosfamide', 'Doxorubicin', 'Trofosfamide', 'doxorubicin']","['progression-free survival', 'dyspnoea and low-grade fatigue', 'efficacy and safety', 'favourable toxicity profile', 'overall survival', 'leukocytopenia, neutropenia and mucositis', '6-month\xa0progression-free rate (PFR', 'number of serious adverse event (SAE', 'Discontinuation rates', 'Survival data']","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4551687', 'cui_str': 'Sarcoma of soft tissue (disorder)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0077375', 'cui_str': 'trofosfamide'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0023530', 'cui_str': 'Leukocytopenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0030735', 'cui_str': 'PEFR'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",120.0,0.0990203,The number of serious adverse event (SAE) was 59% in arm A and 30.3% in arm B (p = 0.005).,"[{'ForeName': 'Joerg T', 'Initials': 'JT', 'LastName': 'Hartmann', 'Affiliation': 'Franziskus Hospital Bielefeld, Catholic Hospital Consortium Eastern Westphalia, Bielefeld, Germany. Electronic address: joerg.hartmann@franziskus.de.'}, {'ForeName': 'Hans-G', 'Initials': 'HG', 'LastName': 'Kopp', 'Affiliation': 'Robert-Bosch Centrum für Tumorerkrankungen (RBCT), Stuttgart, Germany.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Gruenwald', 'Affiliation': 'University Hospital Essen, Internal Medicine (Tumor Research) and Clinic for Urology, Essen, Germany.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Piperno-Neumann', 'Affiliation': 'Medical Oncology Department, Institut Curie, Paris, France.'}, {'ForeName': 'Annegret', 'Initials': 'A', 'LastName': 'Kunitz', 'Affiliation': 'Vivantes Klinikum Spandau, Klinik für Innere Medizin, Hämatologie und Onkologie, Berlin, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Hofheinz', 'Affiliation': 'University Medical Center Mannheim, Mannheim, Germany.'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Mueller', 'Affiliation': 'Onkologie UnterEms, Leer, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Geissler', 'Affiliation': 'Klinikum Esslingen, Department of Hematology/Oncology, Esslingen, Germany.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Horger', 'Affiliation': 'Diagnostic Radiology, Eberhard-Karls-University, Tuebingen, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fix', 'Affiliation': 'Klinikum Weimar, Onkologie, Hämatologie, Palliativmedizin, Weimar, Germany.'}, {'ForeName': 'Jens M', 'Initials': 'JM', 'LastName': 'Chemnitz', 'Affiliation': 'Gemeinschaftsklinikum Mittelrhein GGmbH, Koblenz, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Neise', 'Affiliation': 'Onkologische Schwerpunktpraxis, Krefeld, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wehler', 'Affiliation': 'Evangelisches Krankenhaus, Hamm, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Zander', 'Affiliation': 'Praxis Hämatolgie und Onkologie, Hannover, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Eckert', 'Affiliation': 'Onkologische Schwerpunktpraxis, Esslingen, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Hann von Weyhern', 'Affiliation': 'Department Pathologie, Städtisches Klinikum, München, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Bauer', 'Affiliation': 'West German Cancer Center, University Hospital, Essen, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Mayer', 'Affiliation': 'University Hospital, Medical Center II, Tuebingen, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.10.016']
1112,31852312,"Complex Wound Healing Outcomes for Outpatients Receiving Care via Telemedicine, Home Health, or Wound Clinic: A Randomized Controlled Trial.","Use of telemedicine has expanded rapidly in recent years, yet there are few comparative studies to determine its effectiveness in wound care. To provide experimental data in the field of telemedicine with regard to wound care, a pilot project named ""Domoplaies"" was publicly funded in France in 2011. A randomized, controlled trial was performed to measure the outcomes of patients with complex wounds who received home wound care from a local clinician guided by an off-site wound care expert via telemedicine, versus patients who received in-home or wound clinic visits with wound care professionals. The publicly funded network of nurses and physicians highly experienced in wound healing was used to provide wound care recommendations via telemedicine for the study. The healing rate at 6 months was slightly better for patients who received wound care via telemedicine (61/89; 68.5%) versus wound care professional at home (38/59; 64.4%) versus wound care clinic (22/35; 62.9%), but the difference was not significant ( P  = .860833). The average time to healing for the 121/183 wounds that healed within 6 months was 66.8 ± 32.8 days for the telemedicine group, 69.3 ± 26.7 for the wound care professional at home group, and 55.8 ± 25.0 days for the wound care clinic group. Transportation costs for the telemedicine and home health care groups were significantly lower than the wound clinic group, and death rate was similar between all the 3 groups ( P  < .01). Telemedicine performed by wound healing clinicians working in a network setting offered a safe option to remotely manage comorbid, complex wound care patients with reduced mobility.",2020,"Transportation costs for the telemedicine and home health care groups were significantly lower than the wound clinic group, and death rate was similar between all the 3 groups ( P  < .01).","['Outpatients', 'patients with complex wounds who received home wound care from a local clinician guided by an off-site wound care expert via telemedicine, versus patients who received in-home or wound clinic visits with wound care professionals']","['telemedicine', 'Receiving Care via Telemedicine, Home Health, or Wound Clinic', 'Telemedicine']","['average time to healing', 'Transportation costs', 'death rate', 'Complex Wound Healing Outcomes', 'healing rate']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0886052', 'cui_str': 'Administers care to wound sites'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}]",,0.0417822,"Transportation costs for the telemedicine and home health care groups were significantly lower than the wound clinic group, and death rate was similar between all the 3 groups ( P  < .01).","[{'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Téot', 'Affiliation': 'Montpellier University Hospital, Montpellier, France.'}, {'ForeName': 'Chloé', 'Initials': 'C', 'LastName': 'Geri', 'Affiliation': 'Hospital Home Wound Care Network, Montpellier, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lano', 'Affiliation': 'Hospital Home Wound Care Network, Montpellier, France.'}, {'ForeName': 'Marjorie', 'Initials': 'M', 'LastName': 'Cabrol', 'Affiliation': 'Hospital Home Wound Care Network, Montpellier, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Linet', 'Affiliation': 'Hospital Home Wound Care Network, Montpellier, France.'}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Mercier', 'Affiliation': 'Montpellier University Hospital, Montpellier, France.'}]",The international journal of lower extremity wounds,['10.1177/1534734619894485']
1113,31217498,Phonon blockade in a nanomechanical resonator quadratically coupled to a two-level system.,"We investigate phonon statistics in a nanomechanical resonator (NAMR), which is quadratically coupled to a two-level system, by driving the NAMR and two-level system simultaneously. We find that unconventional phonon blockade (UCPNB), i.e., strong phonon antibunching effect based on quantum interference, can be observed when driven fields are weak. By increasing the strengths of the driving fields, we show the crossover from the UCPNB to the conventional phonon blockade (CPNB), which is induced by the strong nonlinear interaction of the system. Moreover, under the strong coupling condition for CPNB, quantum interference effect can also be used to enhanced the phonon blockade by optimizing the phase difference of the two external driving fields.",2019,"By increasing the strengths of the driving fields, we show the crossover from the UCPNB to the conventional phonon blockade (CPNB), which is induced by the strong nonlinear interaction of the system.",[],['unconventional phonon blockade (UCPNB'],[],[],"[{'cui': 'C3178991', 'cui_str': 'Phonons'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}]",[],2.0,0.0196771,"By increasing the strengths of the driving fields, we show the crossover from the UCPNB to the conventional phonon blockade (CPNB), which is induced by the strong nonlinear interaction of the system.","[{'ForeName': 'Hai-Quan', 'Initials': 'HQ', 'LastName': 'Shi', 'Affiliation': 'School of Materials Science and Engineering, Nanchang University, Nanchang, 330031, China.'}, {'ForeName': 'Xun-Wei', 'Initials': 'XW', 'LastName': 'Xu', 'Affiliation': 'Department of Applied Physics, East China Jiaotong University, Nanchang, 330013, China.'}, {'ForeName': 'Nian-Hua', 'Initials': 'NH', 'LastName': 'Liu', 'Affiliation': 'School of Materials Science and Engineering, Nanchang University, Nanchang, 330031, China. nhliu@ncu.edu.cn.'}]",Scientific reports,['10.1038/s41598-019-45027-z']
1114,31299999,Functional electrical stimulation following anterior cruciate ligament reconstruction: a randomized controlled pilot study.,"BACKGROUND


Inadequate quadriceps strength following anterior cruciate ligament reconstruction (ACLR) often results in alterations in gait pattern that are usually reported during loading response. Neuro-muscular electrical stimulation (NMES) is frequently used to overcome this quadriceps weakness. Despite the beneficial effects of NMES, persistent deficits in strength and gait are reported. The aim of this study was to investigate the feasibility of applying quadriceps functional electrical stimulation (FES) during walking in addition to standard rehabilitation, in the initial stage of ACLR rehabilitation.
METHODS


Subjects were randomized to quadriceps FES synchronized with walking group (n = 10) or quadriceps NMES (duty cycle of 10 s on/10 s off) group (n = 13). Both interventions were performed for 10 min three days a week, in addition to a standard rehabilitation program. Assessments were performed up to 2 weeks before the ACLR (pre-ACLR), and 4 weeks postoperatively. Outcomes measured were gait speed, single limb stance gait symmetry, quadriceps isometric peak strength ratio (peak strength at 4 weeks/peak strength pre-ACLR) and peak strength inter-limb symmetry. Gait outcomes were also assessed 1-week post-surgery.
RESULTS


Subjects in both groups regained pre-ACLR gait speed and symmetry after 4 weeks of rehabilitation, with no difference between groups. However, although pre-ACLR quadriceps peak strength was similar between groups (FES - 205 Nm, NMES - 225 Nm, p = 0.605), subjects in the FES group regained 82% of their pre-quadriceps strength compared to 47% in the NMES group (p = 0.02). In addition, after 4 weeks, the FES group had significantly better inter-limb strength symmetry 0.63 ± 0.15 vs. 0.39 ± 0.18 in the NMES group (p = 0.01).
CONCLUSIONS


Quadriceps FES combined with traditional rehabilitation is a feasible, early intervention treatment option, post-ACLR. Furthermore, at 4 weeks post-surgery, FES was more effective in recovering quadriceps muscle strength than was NMES. While spatiotemporal gait parameters did not differ between groups, kinetic and kinematic studies may be useful to further understand the effects of quadriceps FES post-ACLR. The promising results of this preliminary investigation suggest that such studies are warranted.
TRIAL REGISTRATION


ISRCTN 02817399 . First posted June 29, 2016.",2019,"Furthermore, at 4 weeks post-surgery, FES was more effective in recovering quadriceps muscle strength than was NMES.","['anterior cruciate ligament reconstruction', 'Subjects']","['Neuro-muscular electrical stimulation (NMES', 'quadriceps FES synchronized with walking group (n\xa0=\u200910) or quadriceps NMES', 'anterior cruciate ligament reconstruction (ACLR', 'Functional electrical stimulation', 'quadriceps functional electrical stimulation (FES', 'NMES']","['pre-ACLR gait speed and symmetry', 'quadriceps muscle strength', 'Gait outcomes', 'pre-ACLR quadriceps peak strength', 'gait speed, single limb stance gait symmetry, quadriceps isometric peak strength ratio (peak strength at 4\u2009weeks/peak strength pre-ACLR) and peak strength inter-limb symmetry']","[{'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}]","[{'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0674267', 'cui_str': 'greigite'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0332516', 'cui_str': 'Symmetry'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}]",,0.0512081,"Furthermore, at 4 weeks post-surgery, FES was more effective in recovering quadriceps muscle strength than was NMES.","[{'ForeName': 'Uria', 'Initials': 'U', 'LastName': 'Moran', 'Affiliation': 'Israel Defense Forces Medical Corps, Ariel, Israel.'}, {'ForeName': 'Uri', 'Initials': 'U', 'LastName': 'Gottlieb', 'Affiliation': 'Israel Defense Forces Medical Corps, Ariel, Israel.'}, {'ForeName': 'Arnon', 'Initials': 'A', 'LastName': 'Gam', 'Affiliation': 'Israel Defense Forces Medical Corps, Ariel, Israel.'}, {'ForeName': 'Shmuel', 'Initials': 'S', 'LastName': 'Springer', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, Ariel University, 40700, Ariel, Israel. shmuels@ariel.ac.il.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-019-0566-0']
1115,31330457,"The effect of ultrasound-guided intercostal nerve block, single-injection erector spinae plane block and multiple-injection paravertebral block on postoperative analgesia in thoracoscopic surgery: A randomized, double-blinded, clinical trial.","STUDY OBJECTIVE


The study was to determine the analgesic effect of ultrasound-guided intercostal nerve block (ICNB) and single-injection erector spinae plane block (ESPB) in comparison with multiple-injection paravertebral block (PVB) after thoracoscopic surgery.
DESIGN


Randomized, controlled, double- blinded study.
SETTING


Operating room, postoperative recovery room and ward.
PATIENTS


Seventy-five patients, aged 18-75 years, ASA I-II and scheduled for elective thoracoscopic partial pulmonary resection surgery were enrolled in the study. Seventy-two patients were left for final analysis.
INTERVENTIONS


Patients were randomly assigned into the three groups (PVB group, ICNB group or ESPB group). After anesthesia induction, a single anesthesiologist performed PVB at T5-T7 levels or ICNB at T4-T9 levels or ESPB at T5 level under ultrasound guidance using 20 ml of 0.375% ropivacaine. Patients were connected to the patient-controlled morphine analgesia device after surgery.
MEASUREMENTS


Cumulative morphine consumption at 24 h postoperatively as primary outcome was compared. Visual analog scale pain scores at rest and while coughing at 0, 2, 4, 8, 24 and 48 h postoperatively, cumulative morphine consumption at other observed time and rescue analgesia requirement were also recorded.
MAIN RESULTS


There was a significant difference in median [interquartile range, IQR] morphine consumption at 24 h postoperatively among the three groups (PVB, 10.5 [9-15] mg; ICNB, 18 [13.5-22.1] mg; ESPB, 22 [15-25.1] mg; p = 0.000). This difference was statistically significant for PVB group vs ESPB group (median difference, -7.5; 95% confidence interval [CI], -12 to -4.5; p = 0.000) and PVB group vs ICNB group (median difference, -6; 95% CI, -9 to -3; p = 0.001), but not for ICNB vs ESPB (median difference, -3; 95% CI, -6 to 1.5; p = 0.192). PVB group had significantly lower VAS scores at rest and while coughing than ESPB group at 0, 2, 4, 8 h postoperatively and than ICNB group at 8 h postoperatively. There was no significant difference in the VAS scores between ICNB group and ESPB group at all time. Median VAS scores at rest and while coughing at all time were low (<4) in all groups. More rescue analgesia was needed in ESPB group during 48 postoperative hours (PVB vs ICNB vs ESPB; 13% vs 29% vs 46%; p < 0.05).
CONCLUSIONS


Ultrasound-guided multiple-injection PVB provided superior analgesia to ICNB and single-injection ESPB, while ICNB and single-injection ESPB were equally effective in reducing pain after thoracoscopic surgery.",2020,"PVB group had significantly lower VAS scores at rest and while coughing than ESPB group at 0, 2, 4, 8 h postoperatively and than ICNB group at 8 h postoperatively.","['thoracoscopic surgery', 'comparison with multiple-injection paravertebral block (PVB) after thoracoscopic surgery', 'Seventy-five patients, aged 18-75\u202fyears, ASA I-II and scheduled for elective thoracoscopic partial pulmonary resection surgery were enrolled in the study', 'Operating room, postoperative recovery room and ward']","['ultrasound-guided intercostal nerve block, single-injection erector spinae plane block and multiple-injection paravertebral block', 'PVB', 'ESPB', 'ropivacaine', 'ICNB', 'ultrasound-guided intercostal nerve block (ICNB) and single-injection erector spinae plane block (ESPB', 'ICNB group or ESPB']","['time and rescue analgesia requirement', 'pain', 'Median VAS scores', 'median [interquartile range, IQR] morphine consumption', 'Cumulative morphine consumption', 'Visual analog scale pain scores', 'VAS scores', 'cumulative morphine consumption', 'PVB at T5-T7 levels or ICNB at T4-T9 levels or ESPB', 'rescue analgesia']","[{'cui': 'C0751551', 'cui_str': 'Surgical Procedures, Thoracoscopic'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0396565', 'cui_str': 'Lung excision'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0029064', 'cui_str': 'Operating Room'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0196716', 'cui_str': 'Local anesthetic intercostal nerve block (procedure)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",75.0,0.33233,"PVB group had significantly lower VAS scores at rest and while coughing than ESPB group at 0, 2, 4, 8 h postoperatively and than ICNB group at 8 h postoperatively.","[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Qiao', 'Affiliation': 'Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'RongMin', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'QiaoQiao', 'Initials': 'Q', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: doc_zhang18@163.com.'}, {'ForeName': 'YuKe', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2019.07.002']
1116,31338769,High-intensity interval training combined with resistance training improved apnea-hypopnea index but did not modify oxygen desaturation index and oxygen saturation nadir in obese children with obstructive sleep apnea.,"PURPOSE


To investigate the effect of high-intensity interval training (HIIT) combined with resistance training (RT) on sleep indices and vascular functions in obese children with obstructive sleep apnea (OSA).
METHODS


A quasi-experimental study. Forty-four obese children with OSA were allocated into either an exercise intervention (n = 22) or a usual care control group (n = 22). The exercise group received 24 min of HIIT (> 60% heart rate reserved) and 20 min of RT (50-80% one-repetition maximum), three times per week for 8 weeks. Primary outcomes included the apnea-hypopnea index (AHI), oxygen desaturation index (ODI), and oxygen saturation (SaO 2 ) nadir. Secondary outcomes included the Sleep-Related Breathing Disorder-Pediatric Sleep Questionnaire (SRBD-PSQ) scores, vascular functions (flow-mediated dilation and mean blood flow velocity), and anthropometric variables. Outcomes were measured at baseline, at week 8, and at week 16.
RESULTS


No baseline differences were observed between groups. The compliance rate of exercise training was 99.47%. The AHI significantly decreased in the exercise group compared with the control group at week 16 (median AHI 1.30 to 0.60 and 1.00 to 1.60 episode/h, p = 0.01), but not at week 8. There were no differences between the groups in regard to the ODI and SaO 2  nadir and any secondary outcomes at weeks 8 and 16 (all p > 0.05).
CONCLUSIONS


The eight-week HIIT combined with RT decreased AHI in obese children with OSA at week 16 follow-up. No changes in the ODI, SaO 2  nadir, SRBD-PSQ, vascular function, and anthropometric outcomes were revealed at any time point. Further research is warranted.",2020,There were no differences between the groups in regard to the ODI and SaO 2  nadir and any secondary outcomes at weeks 8 and 16 (,"['obese children with obstructive sleep apnea (OSA', 'Forty-four obese children with OSA', 'obese children with obstructive sleep apnea']","['High-intensity interval training combined with resistance training', 'exercise intervention', 'exercise group received 24\xa0min of HIIT (>\u200960% heart rate reserved) and 20\xa0min of RT', 'high-intensity interval training (HIIT) combined with resistance training (RT', 'usual care control group']","['compliance rate of exercise training', 'apnea-hypopnea index (AHI), oxygen desaturation index (ODI), and oxygen saturation (SaO 2 ) nadir', 'apnea-hypopnea index', 'ODI, SaO 2  nadir, SRBD-PSQ, vascular function, and anthropometric outcomes', 'Sleep-Related Breathing Disorder-Pediatric Sleep Questionnaire (SRBD-PSQ) scores, vascular functions (flow-mediated dilation and mean blood flow velocity), and anthropometric variables', 'sleep indices and vascular functions']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C4319568', 'cui_str': '44'}]","[{'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005798', 'cui_str': 'Blood Flow Velocity'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}]",44.0,0.0188402,There were no differences between the groups in regard to the ODI and SaO 2  nadir and any secondary outcomes at weeks 8 and 16 (,"[{'ForeName': 'Khomkrip', 'Initials': 'K', 'LastName': 'Longlalerng', 'Affiliation': 'Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Nuntigar', 'Initials': 'N', 'LastName': 'Sonsuwan', 'Affiliation': 'Department of Otolaryngology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Sureeporn', 'Initials': 'S', 'LastName': 'Uthaikhup', 'Affiliation': 'Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Suchart', 'Initials': 'S', 'LastName': 'Kietwatanachareon', 'Affiliation': 'Department of Radiologic Technology, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Warunee', 'Initials': 'W', 'LastName': 'Kamsaiyai', 'Affiliation': 'Department of Medical Technology, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Duanpen', 'Initials': 'D', 'LastName': 'Panyasak', 'Affiliation': 'Department of Medical Technology, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Sainatee', 'Initials': 'S', 'LastName': 'Pratanaphon', 'Affiliation': 'Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand. sainatee.pra@cmu.ac.th.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-019-01899-z']
1117,31255890,"Evaluation of ultrasound-guided transversalis fascia plane block for postoperative analgesia in cesarean section: A prospective, randomized, controlled clinical trial.","STUDY OBJECTIVE


Cesarean Delivery (CD) is a commonly performed obstetric procedure. Adding a regional anesthesia technique to multimodal analgesia in CD, may improve the quality of postoperative analgesia. In this study we evaluated the efficacy of Transversalis Fascia Plane Block (TFPB) for postoperative analgesia management in CD.
DESIGN


Blinded, prospective, randomized study.
SETTING


Postoperative recovery room & ward, tertiary university hospital, Istanbul, Turkey, PATIENTS: Seventy-five patients (ASA II-III) scheduled to undergo Cesarean delivery were recruited. Following exclusion, 70 patients were randomized into two equal groups (block and control group).
INTERVENTIONS


Standard multimodal analgesia (routine paracetamol and tramadol PCA in addition to diclophenac sodium as rescue analgesia) was performed in Group C while TFPB block was also performed in the intervention (TFPB) group.
MEASUREMENTS


The primary outcome was tramadol consumption within the first 24 h. The secondary outcome was Numeric Rating Scale (NRS) scores during rest and movement/coughing.
MAIN RESULTS


Tramadol consumption in the first 24 h was 175 ± 72.32 mg in the control and 101.42 ± 51.45 mg in the TFPB group (p < 0.05). NRS was lower in Group TFPB during the first 3 h and at the 12th hour. There was no difference in NRS scores at other hours.
CONCLUSION


Bilateral ultrasound guided TFPB leads to effective analgesia and a decrease in analgesia requirement in first 24 h in patients undergoing CD.",2020,"MAIN RESULTS


Tramadol consumption in the first 24 h was 175 ± 72.32 mg in the control and 101.42 ± 51.45 mg in the TFPB group (p < 0.05).","['Postoperative recovery room & ward, tertiary university hospital, Istanbul, Turkey, PATIENTS: Seventy-five patients (ASA II-III) scheduled to undergo Cesarean delivery were recruited', 'cesarean section', '70 patients']","['Transversalis Fascia Plane Block (TFPB', 'ultrasound-guided transversalis fascia plane block', 'Standard multimodal analgesia (routine paracetamol and tramadol PCA']","['analgesia requirement', 'NRS', 'quality of postoperative analgesia', 'tramadol consumption', 'Numeric Rating Scale (NRS) scores during rest and movement/coughing', 'NRS scores']","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0041400', 'cui_str': 'Turkey'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}]","[{'cui': 'C0225232', 'cui_str': 'Transversalis fascia structure'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0030625', 'cui_str': 'PCA'}]","[{'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",70.0,0.0617133,"MAIN RESULTS


Tramadol consumption in the first 24 h was 175 ± 72.32 mg in the control and 101.42 ± 51.45 mg in the TFPB group (p < 0.05).","[{'ForeName': 'Talat Ercan', 'Initials': 'TE', 'LastName': 'Serifsoy', 'Affiliation': 'Maltepe University Faculty of Medicine, Department of Anesthesiology and Reanimation, Istanbul, Turkey.'}, {'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Tulgar', 'Affiliation': 'Maltepe University Faculty of Medicine, Department of Anesthesiology and Reanimation, Istanbul, Turkey. Electronic address: serkan.tulgar@maltepe.edu.tr.'}, {'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Selvi', 'Affiliation': 'Maltepe University Faculty of Medicine, Department of Anesthesiology and Reanimation, Istanbul, Turkey.'}, {'ForeName': 'Ozgur', 'Initials': 'O', 'LastName': 'Senturk', 'Affiliation': 'Maltepe University Faculty of Medicine, Department of Anesthesiology and Reanimation, Istanbul, Turkey.'}, {'ForeName': 'Erdin', 'Initials': 'E', 'LastName': 'Ilter', 'Affiliation': 'Maltepe University Faculty of Medicine, Department of Obstetrics and Gynecology, Istanbul, Turkey.'}, {'ForeName': 'Berna Haliloglu', 'Initials': 'BH', 'LastName': 'Peker', 'Affiliation': 'Maltepe University Faculty of Medicine, Department of Obstetrics and Gynecology, Istanbul, Turkey.'}, {'ForeName': 'Zeliha', 'Initials': 'Z', 'LastName': 'Ozer', 'Affiliation': 'Maltepe University Faculty of Medicine, Department of Anesthesiology and Reanimation, Istanbul, Turkey.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2019.06.025']
1118,31883526,"Implementation research for public sector mental health care scale-up (SMART-DAPPER): a sequential multiple, assignment randomized trial (SMART) of non-specialist-delivered psychotherapy and/or medication for major depressive disorder and posttraumatic stress disorder (DAPPER) integrated with outpatient care clinics at a county hospital in Kenya.","BACKGROUND


Mental disorders are a leading cause of global disability, driven primarily by depression and anxiety. Most of the disease burden is in Low and Middle Income Countries (LMICs), where 75% of adults with mental disorders have no service access. Our research team has worked in western Kenya for nearly ten years. Primary care populations in Kenya have high prevalence of Major Depressive Disorder (MDD) and Posttraumatic Stress Disorder (PTSD). To address these treatment needs with a sustainable, scalable mental health care strategy, we are partnering with local and national mental health stakeholders in Kenya and Uganda to identify 1) evidence-based strategies for first-line and second-line treatment delivered by non-specialists integrated with primary care, 2) investigate presumed mediators of treatment outcome and 3) determine patient-level moderators of treatment effect to inform personalized, resource-efficient, non-specialist treatments and sequencing, with costing analyses. Our implementation approach is guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework.
METHODS/DESIGN


We will use a Sequential, Multiple Assignment Randomized Trial (SMART) to randomize 2710 patients from the outpatient clinics at Kisumu County Hospital (KCH) who have MDD, PTSD or both to either 12 weekly sessions of non-specialist-delivered Interpersonal Psychotherapy (IPT) or to 6 months of fluoxetine prescribed by a nurse or clinical officer. Participants who are not in remission at the conclusion of treatment will be re-randomized to receive the other treatment (IPT receives fluoxetine and vice versa) or to combination treatment (IPT and fluoxetine). The SMART-DAPPER Implementation Resource Team, (IRT) will drive the application of the EPIS model and adaptations during the course of the study to optimize the relevance of the data for generalizability and scale -up.
DISCUSSION


The results of this research will be significant in three ways: 1) they will determine the effectiveness of non-specialist delivered first- and second-line treatment for MDD and/or PTSD, 2) they will investigate key mechanisms of action for each treatment and 3) they will produce tailored adaptive treatment strategies essential for optimal sequencing of treatment for MDD and/or PTSD in low resource settings with associated cost information - a critical gap for addressing a leading global cause of disability.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03466346, registered March 15, 2018.",2019,"We will use a Sequential, Multiple Assignment Randomized Trial (SMART) to randomize 2710 patients from the outpatient clinics at Kisumu County Hospital (KCH) who have MDD, PTSD or both to either 12 weekly sessions of non-specialist-delivered Interpersonal Psychotherapy (IPT) or to 6 months of fluoxetine prescribed by a nurse or clinical officer.","['Primary care populations in Kenya have high prevalence of Major Depressive Disorder (MDD) and Posttraumatic Stress Disorder (PTSD', '2710 patients from the outpatient clinics at Kisumu County Hospital (KCH) who have MDD, PTSD or both to either 12 weekly sessions of non-specialist-delivered Interpersonal Psychotherapy (IPT) or to 6\u2009months of fluoxetine prescribed by a nurse or clinical officer', 'Participants who are not in remission at the conclusion of treatment will be re-randomized to receive the other', 'adults with mental disorders', 'major depressive disorder and posttraumatic stress disorder (DAPPER) integrated with outpatient care clinics at a county hospital in Kenya']","['treatment (IPT receives fluoxetine and vice versa) or to combination treatment (IPT and fluoxetine', 'psychotherapy and/or medication']",[],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0020005', 'cui_str': 'Hospitals, County'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy (regime/therapy)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}]",[],2710.0,0.0328138,"We will use a Sequential, Multiple Assignment Randomized Trial (SMART) to randomize 2710 patients from the outpatient clinics at Kisumu County Hospital (KCH) who have MDD, PTSD or both to either 12 weekly sessions of non-specialist-delivered Interpersonal Psychotherapy (IPT) or to 6 months of fluoxetine prescribed by a nurse or clinical officer.","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Levy', 'Affiliation': 'Medical School, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Muthoni', 'Initials': 'M', 'LastName': 'Mathai', 'Affiliation': 'Department of Psychiatry, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Purba', 'Initials': 'P', 'LastName': 'Chatterjee', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Linnet', 'Initials': 'L', 'LastName': 'Ongeri', 'Affiliation': 'Kenya Medical Research Institute (KEMRI), Nairobi, Kenya.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Njuguna', 'Affiliation': 'Director of Mental Health, Kenyan Ministry of Health, Nairobi, Kenya.'}, {'ForeName': 'Dickens', 'Initials': 'D', 'LastName': 'Onyango', 'Affiliation': 'Kisumu County, Ministry of Health, Kisumu, Kenya.'}, {'ForeName': 'Dickens', 'Initials': 'D', 'LastName': 'Akena', 'Affiliation': 'Department of Psychiatry, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Rota', 'Affiliation': 'University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Ammon', 'Initials': 'A', 'LastName': 'Otieno', 'Affiliation': 'University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Neylan', 'Affiliation': 'Departments of Psychiatry and Neurology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Hafsa', 'Initials': 'H', 'LastName': 'Lukwata', 'Affiliation': 'Division of Mental Health and Control of Substance Abuse, Ministry of Health -, Kampala, Uganda.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Kahn', 'Affiliation': 'Department of Epidemiology and Biostatistics, Institute for Health Policy Studies, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Cohen', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, UC Global Health Institute, San Francisco, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bukusi', 'Affiliation': 'Department of Psychiatry, Kenyatta National Hospital, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Aarons', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, CA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Burger', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Blum', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Inbal', 'Initials': 'I', 'LastName': 'Nahum-Shani', 'Affiliation': 'Institute for Social Research, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'McCulloch', 'Affiliation': 'Division of Mental Health and Control of Substance Abuse, Ministry of Health -, Kampala, Uganda.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Meffert', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, CA, USA. Susan.Meffert@ucsf.edu.'}]",BMC psychiatry,['10.1186/s12888-019-2395-x']
1119,31142441,Analysis from the EMPA-REG OUTCOME ®  trial indicates empagliflozin may assist in preventing the progression of chronic kidney disease in patients with type 2 diabetes irrespective of medications that alter intrarenal hemodynamics.,"In patients with type 2 diabetes mellitus (T2DM) and cardiovascular (CV) disease, empagliflozin (EMPA) decreased progression of chronic kidney disease (CKD), likely via a reduction in intraglomerular pressure. Due to prevalent comorbidities, such as hypertension and albuminuria, patients often receive other agents that alter intrarenal hemodynamics, including angiotensin converting enzyme inhibitors/angiotensin receptor blockers (ACEi/ARBs), calcium channel blockers (CCBs) and diuretics. Nonsteroidal anti-inflammatory drugs (NSAIDs) may also be used by some individuals. In this exploratory, non-prespecified analysis, we investigated whether the kidney benefits of EMPA are altered in individuals already using the medications in these categories. In the BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME ® ) trial, 7020 patients were essentially equally randomized to EMPA 10 mg, 25 mg or placebo added to their standard care. Differences in risk of incident or worsening nephropathy for pooled EMPA vs placebo across subgroups by baseline background medications (to which patients were not randomized) were assessed using a Cox proportional hazards model. Risk reductions in incident or worsening nephropathy with EMPA were consistent across medication subgroups, with no heterogeneity of treatment effect. As a representative example, the risk for acute renal failure was overall slightly increased in patients using ACEi/ARBs in all groups (placebo, EMPA 10 mg or EMPA 25 mg) but incidence rates were numerically lower in those assigned to EMPA. Similar patterns were observed for other medications included in this analysis. Thus, EMPA may assist to prevent CKD progression in patients with T2DM with CV disease, irrespective of common background medications that alter intrarenal hemodynamics, and without increasing acute renal adverse events.",2019,"Risk reductions in incident or worsening nephropathy with EMPA were consistent across medication subgroups, with no heterogeneity of treatment effect.","['Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME ® ) trial', '7020 patients', 'patients with type 2 diabetes', 'patients with type 2 diabetes mellitus (T2DM) and cardiovascular (CV) disease', 'patients with T2DM with CV disease']","['empagliflozin', 'placebo', 'empagliflozin (EMPA', 'BI 10773 (Empagliflozin', 'EMPA', 'EMPA 10 mg, 25 mg or placebo', 'Nonsteroidal anti-inflammatory drugs (NSAIDs']","['chronic kidney disease', 'risk of incident or worsening nephropathy', 'incidence rates', 'acute renal failure']","[{'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3490349', 'cui_str': 'BI10773'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}]","[{'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3854173', 'cui_str': 'Pre-renal acute kidney injury'}]",7020.0,0.0746079,"Risk reductions in incident or worsening nephropathy with EMPA were consistent across medication subgroups, with no heterogeneity of treatment effect.","[{'ForeName': 'Gert J', 'Initials': 'GJ', 'LastName': 'Mayer', 'Affiliation': 'Department of Internal Medicine IV (Nephrology and Hypertension), Medical University, Innsbruck, Austria.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Division of Nephrology, Würzburg University Clinic, Würzburg, Germany.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Weir', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Koitka-Weber', 'Affiliation': 'Division of Nephrology, Würzburg University Clinic, Würzburg, Germany; Boehringer Ingelheim International GmbH, Ingelheim, Germany; Department of Diabetes, Central Clinical School, Monash University, Melbourne, Australia.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Hantel', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'von Eynatten', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Canada.'}, {'ForeName': 'David Z I', 'Initials': 'DZI', 'LastName': 'Cherney', 'Affiliation': 'Department of Medicine and Department of Physiology, Division of Nephrology, University Health Network, University of Toronto, Canada. Electronic address: david.cherney@uhn.ca.'}]",Kidney international,['10.1016/j.kint.2019.02.033']
1120,32208555,"Reply to the article: Nicholas C. Dang, Abbas Ardehali, Brian A. Bruckner, Patrick E. Parrino, Daniel L. Gillen, Rachel W. Hoffman, Russell Spotnitz, Stephanie Cavoores, Ian J. Shorn, Roberto J. Manson, William D. Spotnitz. Prospective, multicenter, randomized, controlled trial evaluating the performance of a novel combination powder vs hemostatic matrix in cardiothoracic operations. J Card Surg. 2019;1-7. DOI: 10.1111/jocs.14376.",,2020,,['cardiothoracic operations'],"['novel combination powder vs hemostatic matrix', 'DOI']",[],"[{'cui': 'C0038895', 'cui_str': 'operative therapy'}]","[{'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0019120', 'cui_str': 'Hemostatics'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}]",[],,0.0426733,,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Spazierer', 'Affiliation': 'Surgical Sciences and Engineering, Baxter Medical Products GmbH, Vienna, Austria.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Moersdorf', 'Affiliation': 'Advanced Surgery DACH, Baxter Deutschland GmbH, Unterschleissheim, Germany.'}]",Journal of cardiac surgery,['10.1111/jocs.14509']
1121,32028083,Effects of hydrocortisone and yohimbine on decision-making under risk.,"INTRODUCTION


Many studies have investigated the influence of stress on decision-making. However, results are equivocal and the exact role of increased noradrenaline and cortisol after stress remains unclear. Using pharmacological manipulation, we investigated the influence of noradrenergic and glucocorticoid activity on risky decision-making in a gambling task that included mixed-gamble trials (gains and losses are possible) and gain-only trials.
METHODS AND MATERIALS


One hundred-and-four healthy young men participated in our randomized, double-blind, placebo-controlled, between-group study. Participants were randomly assigned to one of four groups: (A) yohimbine, (B) hydrocortisone, (C) yohimbine and hydrocortisone, or (D) placebo. Frequency of risky choices, i.e., monetary risk taking, was the dependent variable. We also investigated the influence of hydrocortisone and yohimbine on loss aversion, which is the tendency to overweigh losses compared with gains.
RESULTS


Participants chose the risky option less often after receiving hydrocortisone compared with no hydrocortisone. This effect was strongest in the gain-only trials. Yohimbine had no effect. Loss aversion was not affected by hydrocortisone or yohimbine.
DISCUSSION


Decreased reward processing may explain the reduction of risk taking by hydrocortisone in gain-only trials. The effects of stress hormones on different decision-related constructs and processes hence require further investigation.",2020,"Loss aversion was not affected by hydrocortisone or yohimbine.
",['One hundred-and-four healthy young men'],"['yohimbine, (B) hydrocortisone, (C) yohimbine and hydrocortisone, or (D) placebo', 'placebo', 'noradrenergic and glucocorticoid activity', 'Yohimbine', 'hydrocortisone and yohimbine', 'hydrocortisone']",['Loss aversion'],"[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0724441', 'cui_str': 'yohimbine'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C0233496', 'cui_str': 'Aversion (finding)'}]",104.0,0.284296,"Loss aversion was not affected by hydrocortisone or yohimbine.
","[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Metz', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Waiblinger-Grigull', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schulreich', 'Affiliation': 'Department of Psychology, University of Hamburg, Germany.'}, {'ForeName': 'Woo Ri', 'Initials': 'WR', 'LastName': 'Chae', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Otte', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Hauke R', 'Initials': 'HR', 'LastName': 'Heekeren', 'Affiliation': 'Department of Education and Psychology, Freie Universität Berlin, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Wingenfeld', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany. Electronic address: katja.wingenfeld@charite.de.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104589']
1122,32492080,Effect of Aspirin vs Placebo on the Prevention of Depression in Older People: A Randomized Clinical Trial.,"Importance


Depression is associated with increased inflammation, which may precede its onset, especially in older people. Some preclinical data suggest potential antidepressant effects of aspirin, supported by limited observational data suggesting lower rates of depression in individuals treated with aspirin. There currently appears to be no evidence-based pharmacotherapies for the primary prevention of depression.
Objective


To determine whether low-dose aspirin (100 mg) reduces the risk of depression in healthy older adults.
Design, Setting, and Participants


This double-blinded, placebo-controlled randomized clinical trial was a substudy of the Aspirin in Reducing Events in the Elderly (ASPREE) trial, which examined if aspirin increased healthy life span, defined as survival free of dementia and disability. The prespecified secondary outcome was depression. Individuals of all races/ethnicities older than 70 years in Australia, as well as white individuals older than 70 years and black and Hispanic individuals older than 65 years in the United States, were included.
Interventions


Participants were randomized to aspirin (100 mg daily) or placebo, with a median (interquartile range) follow-up of 4.7 (3.5-5.6) years.
Main Outcomes and Measures


The primary outcome was a proxy measure of major depressive disorder defined as a score of 8 or more on the Center for Epidemiologic Studies Depression 10-item (CES-D-10) scale.
Results


Of the 19 114 participants enrolled in the trial, 9525 received aspirin and 9589 received a placebo. The mean (SD) age was 75.2 (4.0) years in the aspirin group and 75.1 (4.5) years in the placebo group; 9531 (56.4%) were women. Participants' demographics and clinical characteristics at baseline were similar between groups. A total of 79 886 annual CES-D-10 measurements were taken, with a mean of 4.2 measurements per participant. There were no significant differences at annual visits in the proportions of CES-D-10 scores of 8 or more between the aspirin and placebo groups. The incidence rate of new CES-D-10 scores of 8 or more was 70.4 events per 1000 person-years in the aspirin group and 69.1 in the placebo group (hazard ratio, 1.02 [95% CI, 0.96-1.08]; P = .54).
Conclusions and Relevance


Low-dose aspirin did not prevent depression in this large-scale study of otherwise healthy older adults.
Trial Registration


ClinicalTrials.gov Identifier: NCT01038583.",2020,There were no significant differences at annual visits in the proportions of CES-D-10 scores of 8 or more between the aspirin and placebo groups.,"['The mean (SD) age was 75.2\u2009(4.0) years in the aspirin group and 75.1\u2009(4.5) years in the placebo group; 9531 (56.4%) were women', 'otherwise healthy older adults', 'Individuals of all races/ethnicities older than 70 years in Australia, as well as white individuals older than 70 years and black and Hispanic individuals older than 65 years in the United States, were included', '19\u202f114 participants enrolled in the trial, 9525 received', 'healthy older adults', 'Older People']","['Aspirin vs Placebo', 'Aspirin', 'aspirin', 'low-dose aspirin', 'placebo']","['risk of depression', 'healthy life span', 'survival free of dementia and disability', 'depression', 'proxy measure of major depressive disorder defined as a score of 8 or more on the Center for Epidemiologic Studies Depression 10-item', 'incidence rate of new CES-D-10\u2009scores']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0870809', 'cui_str': 'Lifespan'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002783', 'cui_str': 'Studies, Epidemiologic'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0559741', 'cui_str': 'Item score'}]",19114.0,0.692445,There were no significant differences at annual visits in the proportions of CES-D-10 scores of 8 or more between the aspirin and placebo groups.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Berk', 'Affiliation': 'The Institute for Mental and Physical Health and Clinical Translation Strategy Research Centre, Deakin University School of Medicine, Geelong, Australia.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Woods', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'Raj C', 'Initials': 'RC', 'LastName': 'Shah', 'Affiliation': ""Rush Alzheimer's Disease Center, Department of Family Medicine, Rush University Medical Center, Chicago, Illinois.""}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Elsdon', 'Initials': 'E', 'LastName': 'Storey', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Sharyn', 'Initials': 'S', 'LastName': 'Fitzgerald', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Lockery', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Mohebbi', 'Affiliation': 'The Institute for Mental and Physical Health and Clinical Translation Strategy Research Centre, Deakin University School of Medicine, Geelong, Australia.'}, {'ForeName': 'Seetal', 'Initials': 'S', 'LastName': 'Dodd', 'Affiliation': 'The Institute for Mental and Physical Health and Clinical Translation Strategy Research Centre, Deakin University School of Medicine, Geelong, Australia.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Murray', 'Affiliation': 'Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Minneapolis, Minnesota.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Stocks', 'Affiliation': 'Discipline of General Practice, Adelaide Medical School, University of Adelaide, Australia.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Fitzgerald', 'Affiliation': 'Epworth Centre for Innovation in Mental Health, the Epworth Clinic, Epworth Healthcare, Camberwell, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Mazza', 'Affiliation': 'The Institute for Mental and Physical Health and Clinical Translation Strategy Research Centre, Deakin University School of Medicine, Geelong, Australia.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Agustini', 'Affiliation': 'The Institute for Mental and Physical Health and Clinical Translation Strategy Research Centre, Deakin University School of Medicine, Geelong, Australia.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McNeil', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.1214']
1123,31330502,Effects of Suspension Versus Traditional Resistance Training on Explosive Strength in Elementary School-Aged Boys.,"PURPOSE


The aim of this study was to determine the effects of an 8-week program of resistance training (RT) or suspension training (ST) on explosive strength in prepubescent boys.
METHODS


Fifty-seven boys aged 10-11 years were assigned to 2 training groups, RT or ST or a control group (no training program). Boys trained twice weekly for 8 weeks.
RESULTS


A significant interaction was reported with a large (P < .001, ηp2=.463), medium (P < .001, ηp2=.395), and small effect sized (P ≤ .001, ηp2=.218) in the 1-kg ball throw, 3-kg ball throw, and time-at-20-m test, respectively. There was no significant interaction in the countermovement vertical jump or the standing long jump. Changes from preintervention to postintervention for the 1-kg ball throw were 5.94% and 5.82% for the ST and RT, respectively, and 8.82% and 8.14% in the 3-kg ball throw for the ST and RT, respectively. The improvement in the 20-m sprint was 1.19% for the ST and 2.33% for the RT.
CONCLUSION


Traditional RT and ST seem to be effective methods for improving explosive strength in prepubescent boys. ST could be considered as an alternative modality to optimize explosive strength training in school-based programs.",2019,There was no significant interaction in the countermovement vertical jump or the standing long jump.,"['prepubescent boys', 'Fifty-seven boys aged 10-11 years', 'Elementary School-Aged Boys']","['Suspension Versus Traditional Resistance Training', 'resistance training (RT) or suspension training (ST', 'RT or ST or a control group (no training program']","['Explosive Strength', 'countermovement vertical jump or the standing long jump', 'explosive strength', '20-m sprint']","[{'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C1382107', 'cui_str': 'Suspension'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1721090', 'cui_str': 'Explosives'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",,0.0167912,There was no significant interaction in the countermovement vertical jump or the standing long jump.,"[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Marta', 'Affiliation': 'Polytechnic Institute of Guarda.'}, {'ForeName': 'Ana R', 'Initials': 'AR', 'LastName': 'Alves', 'Affiliation': 'Polytechnic Institute of Beja.'}, {'ForeName': 'Pedro T', 'Initials': 'PT', 'LastName': 'Esteves', 'Affiliation': 'Polytechnic Institute of Guarda.'}, {'ForeName': 'Natalina', 'Initials': 'N', 'LastName': 'Casanova', 'Affiliation': 'Polytechnic Institute of Guarda.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Marinho', 'Affiliation': 'Research Centre in Sports Sciences, Health Sciences and Human Development.'}, {'ForeName': 'Henrique P', 'Initials': 'HP', 'LastName': 'Neiva', 'Affiliation': 'Research Centre in Sports Sciences, Health Sciences and Human Development.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Aguado-Jimenez', 'Affiliation': 'Public University of Navarre.'}, {'ForeName': 'Alicia M', 'Initials': 'AM', 'LastName': 'Alonso-Martínez', 'Affiliation': 'Public University of Navarre.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Public University of Navarre.'}, {'ForeName': 'Mário C', 'Initials': 'MC', 'LastName': 'Marques', 'Affiliation': 'Research Centre in Sports Sciences, Health Sciences and Human Development.'}]",Pediatric exercise science,['10.1123/pes.2018-0287']
1124,31326395,"A Phase IV, Randomized, Double-Blind, Placebo-Controlled Crossover Study of the Effects of Ustekinumab on Vascular Inflammation in Psoriasis (the VIP-U Trial).","Psoriasis is a T helper type 17 autoimmune disease associated with an increased risk cardiovascular events and mortality. Ustekinumab, an antibody to p40, blocks cytokines IL-12 and IL-23, and is a highly effective and safe treatment for psoriasis. We conducted a randomized double-blinded placebo-controlled trial to determine the effect of ustekinumab on aortic vascular inflammation (AVI) measured by imaging, and key biomarkers of inflammation, lipid, and glucose metabolism in the blood of patients with moderate-to-severe psoriasis. A total of 43 patients were randomized, and at week 12, ustekinumab-treated patients had a -18.65% (95% confidence interval = -29.45% to -7.85%) reduction in AVI, a reduction in inflammatory biomarkers, and an increase in apolipoprotein B lipoproteins compared with placebo. At week 12, placebo patients were crossed over such that all patients received ustekinumab for 52 weeks. At the end of 52 weeks of ustekinumab treatment, there was no change in AVI compared with baseline, inflammatory markers were reduced, and there were increases in selected measures of lipids and leptin. These results show that blockade of IL-12 and/or IL-23 may transiently reduce AVI, with more durable reduction in inflammatory cytokines associated with cardiovascular disease.",2020,"At the end of 52 weeks of ustekinumab treatment there was no change in aortic vascular inflammation compared to baseline, inflammatory markers were reduced and there were increases in selected measures of lipids and leptin.
","['patients with moderate to severe psoriasis', '43 patients']","['placebo', 'Placebo', 'ustekinumab', 'Ustekinumab']","['apolipoprotein-B lipoproteins', 'inflammatory markers', 'aortic vascular inflammation', 'selected measures of lipids and leptin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}]","[{'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0947751', 'cui_str': 'Vascular inflammations'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0299583', 'cui_str': 'leptin'}]",43.0,0.557078,"At the end of 52 weeks of ustekinumab treatment there was no change in aortic vascular inflammation compared to baseline, inflammatory markers were reduced and there were increases in selected measures of lipids and leptin.
","[{'ForeName': 'Joel M', 'Initials': 'JM', 'LastName': 'Gelfand', 'Affiliation': 'Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA. Electronic address: Joel.Gelfand@pennmedicine.upenn.edu.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Shin', 'Affiliation': 'Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Abass', 'Initials': 'A', 'LastName': 'Alavi', 'Affiliation': 'Department of Radiology (Nuclear Medicine), Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Drew A', 'Initials': 'DA', 'LastName': 'Torigian', 'Affiliation': 'Department of Radiology (Nuclear Medicine), Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Werner', 'Affiliation': 'Department of Radiology (Nuclear Medicine), Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Maryte', 'Initials': 'M', 'LastName': 'Papadopoulos', 'Affiliation': 'Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Takeshita', 'Affiliation': 'Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Megan H', 'Initials': 'MH', 'LastName': 'Noe', 'Affiliation': 'Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Amit K', 'Initials': 'AK', 'LastName': 'Dey', 'Affiliation': 'Section of Inflammation and Cardiometabolic Diseases, National Heart Lung Blood Institute, Bethesda, Maryland, USA.'}, {'ForeName': 'Martin P', 'Initials': 'MP', 'LastName': 'Playford', 'Affiliation': 'Section of Inflammation and Cardiometabolic Diseases, National Heart Lung Blood Institute, Bethesda, Maryland, USA.'}, {'ForeName': 'Nehal N', 'Initials': 'NN', 'LastName': 'Mehta', 'Affiliation': 'Section of Inflammation and Cardiometabolic Diseases, National Heart Lung Blood Institute, Bethesda, Maryland, USA.'}]",The Journal of investigative dermatology,['10.1016/j.jid.2019.07.679']
1125,32062371,Remitted depression and cognition in HIV: The role of cortisol and inflammation.,"In major depressive disorder (MDD) and remitted MDD (rMDD) alterations in cortisol and inflammation are associated with cognitive difficulties, but these relationships have not been investigated in HIV. We used secondary data from a placebo-controlled, cross-over study of cognitive performance following a probe of the hypothalamic-pituitary-adrenal (HPA) axis (low dose hydrocortisone; LDH 10 mg) in 65 people with HIV (PWH; 36 women). Using placebo data, we examined sex-specific associations between two biomarkers - basal afternoon salivary cortisol and salivary inflammatory cytokines - cognition, and rMDD. Salivary cortisol and inflammatory biomarkers were sampled across the 5 -h study. The panel of inflammatory markers included interleukin (IL)-6, IL-8, IL-1β, tumor necrosis factor-(TNF)-α, CRP, interferon gamma-induced protein (IP-10), monocyte chemotactic protein (MCP)-1, monokine induced by interferon (MIG), matrix metalloproteinase MMP-9, and MMP-1. Learning, memory, attention/concentration, and executive function were assessed 30 min and 4 h after the placebo intervention; visuospatial ability was also assessed 30 min after the placebo intervention. For women but not men with HIV, basal cortisol concentrations were higher in rMDD versus noMDD groups, and related to poorer learning and memory. For men and women with HIV, basal inflammatory cytokines were higher in rMDD versus noMDD groups, but were negatively related to cognition independent of rMDD status. Cortisol and cytokines relate to cognition in PWH, but the associations depended on sex, rMDD status, and their interaction.",2020,"For women but not men with HIV, basal cortisol concentrations were higher in rMDD versus noMDD groups, and related to poorer learning and memory.",['65 people with HIV (PWH; 36 women'],['hypothalamic-pituitary-adrenal (HPA) axis (low dose hydrocortisone; LDH'],"['biomarkers - basal afternoon salivary cortisol and salivary inflammatory cytokines - cognition, and rMDD', 'Salivary cortisol and inflammatory biomarkers', 'interleukin (IL)-6, IL-8, IL-1β, tumor necrosis factor-(TNF)-α, CRP, interferon gamma-induced protein (IP-10), monocyte chemotactic protein (MCP)-1, monokine induced by interferon (MIG), matrix metalloproteinase MMP-9, and MMP-1', 'basal inflammatory cytokines', 'Learning, memory, attention/concentration, and executive function', 'basal cortisol concentrations']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0022922', 'cui_str': 'lactate dehydrogenase-K'}]","[{'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0439550', 'cui_str': 'Afternoon (qualifier value)'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0021745', 'cui_str': 'interferon gamma'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0128897', 'cui_str': 'Chemokine (C-C Motif) Ligand 2'}, {'cui': 'C0026484', 'cui_str': 'Monokines'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",65.0,0.124238,"For women but not men with HIV, basal cortisol concentrations were higher in rMDD versus noMDD groups, and related to poorer learning and memory.","[{'ForeName': 'Leah H', 'Initials': 'LH', 'LastName': 'Rubin', 'Affiliation': 'Department of Neurology and Psychiatry, Johns Hopkins University School of Medicine, Baltimore, MD, United States; Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States. Electronic address: lrubin1@jhmi.edu.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Langenecker', 'Affiliation': 'Department of Psychiatry, University of Utah, Salt Lake City, UT, United States.'}, {'ForeName': 'K Luan', 'Initials': 'KL', 'LastName': 'Phan', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, United States.'}, {'ForeName': 'Sheila M', 'Initials': 'SM', 'LastName': 'Keating', 'Affiliation': 'Blood Systems Research Institute, San Francisco, CA, United States.'}, {'ForeName': 'Gretchen N', 'Initials': 'GN', 'LastName': 'Neigh', 'Affiliation': 'Departments of Anatomy and Neurobiology, Virginia Commonwealth University, Richmond, VA, United States.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Weber', 'Affiliation': 'CORE Center, Cook County Health and Hektoen Institute of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Pauline M', 'Initials': 'PM', 'LastName': 'Maki', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, United States; Department of Psychology, University of Illinois at Chicago, Chicago, IL, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104609']
1126,32491941,Effect of computer-assisted-learning and simulation clinics on dental students' cognitive and performance skills: panoramic image errors related to patient's head position.,"OBJECTIVES


To assess dental students' ability to recognize head positioning errors in panoramic (PAN) images after individual learning via computer-assisted-learning (CAL) and in a simulation clinic (SIM). Both cognitive skills and performance in patient examination were assessed.
METHODS AND MATERIALS


60 students (mean age 23.25 years) participated in lectures on the relation between PAN-image errors and patient's head position. Immediately after they took a test, based on which they were randomized to three groups: control (CON) group, CAL group, and SIM group (both CAL and training in a simulation clinic with a phantom). 4-5 weeks after intervention/no intervention, all students individually examined a patient with PAN-exposure. A blinded rater, not knowing group allocation, supervised patient exposure and assessed student's performance (correct/incorrect head position in three planes). 1-2 weeks after, the students scored positioning errors in 40 PAN-images. Differences in cognitive test scores between groups were evaluated by ANOVA and in patient examination by χ 2  tests, and within-group differences by sign-tests.
RESULTS


No statistically significant difference in cognitive test scores was seen between the SIM and CAL group, while the CON group scored lower ( p  < 0.003). In all groups, several students positioned the patient incorrectly in the Frankfort horizontal plane. All students performed well in the sagittal plane. Students in SIM group positioned the patient more correctly in the coronal plane.
CONCLUSIONS


Training with CAL increased students' cognitive skills compared with a control group. Simulated patient exposure with a phantom increased to some extent their performance skills in examination of patients.",2020,"No statistically significant difference in cognitive test scores was seen between the SIM and CAL group, while the CON group scored lower ( p  < 0.003).","[""dental students' cognitive and performance skills"", ""Sixty students (mean age 23.25 years) participated in lectures on the relation between PAN-image errors and patient's head position""]","['control (CON)group, CAL group, and SIM group (both CAL and training in a simulation clinic with a phantom', 'individual learning via computer-assisted-learning (CAL', 'computer-assisted-learning and simulation clinics', 'CON', 'Training with computer-assisted-learning']","[""students' cognitive skills"", 'cognitive test scores']","[{'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0582540', 'cui_str': 'Head position finding'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0282611', 'cui_str': 'Phantom'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.0253438,"No statistically significant difference in cognitive test scores was seen between the SIM and CAL group, while the CON group scored lower ( p  < 0.003).","[{'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Wenzel', 'Affiliation': 'Section for Oral Radiology, Department of Dentistry and Oral Health, Health Faculty, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Louise Hauge', 'Initials': 'LH', 'LastName': 'Matzen', 'Affiliation': 'Section for Oral Radiology, Department of Dentistry and Oral Health, Health Faculty, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Rubens', 'Initials': 'R', 'LastName': 'Spin-Neto', 'Affiliation': 'Section for Oral Radiology, Department of Dentistry and Oral Health, Health Faculty, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Schropp', 'Affiliation': 'Section for Oral Radiology, Department of Dentistry and Oral Health, Health Faculty, Aarhus University, Aarhus, Denmark.'}]",Dento maxillo facial radiology,['10.1259/dmfr.20200154']
1127,31291207,Evaluating the Use of a Computerized CBT Program for Outpatients on a Waitlist in a University CBT Unit.,"OBJECTIVES AND DESIGN


The goal of this pilot randomized controlled trial was to determine whether a computerized cognitive-behavioral therapy (cCBT) program for depression and anxiety could reduce symptoms in outpatients on a waitlist for face-to-face CBT for a variety of mental health complaints.
METHODS


Sixty-seven outpatients referred for CBT for disparate problems (eg, anxiety, depression, obsessions or compulsions) were randomized to 1 of 2 conditions: (1) the cCBT program ""Good Days Ahead,"" which included weekly guidance and support, or (2) a control condition where patients were referred to a freely available online CBT workbook. Measures of psychological distress were administered at the start of study and at the end of the waiting period, when participants were formally diagnosed and assessed for face-to-face therapy.
RESULTS


For the most part, mixed-design analyses of variances revealed no statistically significant changes in symptom measures over time. Nonsignificant interactions and modest effect sizes between groups across time suggest that the cCBT group did not do better than the control group. The majority of cCBT participants reported that the program was ""very"" or ""extremely useful,"" while only a portion of the control group felt the same about the workbook. There were notable differences in the completion rates of the 2 groups in favor of the cCBT program.
CONCLUSIONS


Offering a general cCBT program to waiting list patients may not confer an advantage over referring them to an online workbook, at least in terms of symptom reduction. Results could be partly explained by difficulties translating knowledge into practice, especially if participants' main problem was not directly addressed by the intervention.",2019,"list patients may not confer an advantage over referring them to an online workbook, at least in terms of symptom reduction.","['Sixty-seven outpatients referred for CBT for disparate problems (eg, anxiety, depression, obsessions or compulsions', 'outpatients on a waitlist for face-to-face CBT for a variety of mental health complaints', 'Outpatients on a Waitlist in a University CBT Unit']","['cCBT program ""Good Days Ahead,"" which included weekly guidance and support, or (2) a control condition where patients were referred to a freely available online CBT workbook', 'computerized cognitive-behavioral therapy (cCBT) program', 'Computerized CBT Program', 'cCBT']","['psychological distress', 'completion rates']","[{'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0233697', 'cui_str': 'Obsessions'}, {'cui': 'C0600104', 'cui_str': 'Compulsive Behavior'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1998288', 'cui_str': 'Computerized cognitive behavioral therapy'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",67.0,0.0301017,"list patients may not confer an advantage over referring them to an online workbook, at least in terms of symptom reduction.","[{'ForeName': 'Rosanne', 'Initials': 'R', 'LastName': 'Villemaire-Krajden', 'Affiliation': 'VILLEMAIRE-KRAJDEN and MYHR: Department of Psychiatry, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Myhr', 'Affiliation': ''}]",Journal of psychiatric practice,['10.1097/PRA.0000000000000396']
1128,31305506,REDUCTION OF POSTINTRAVITREAL INJECTION PAIN USING ICE: An Open-Label Interventional Randomized Controlled Trial.,"PURPOSE


Intravitreal injections of intraocular therapeutic agents are a common and effective treatment for various retinal pathologies. Patient discomfort related to injection is a potential barrier to treatment. Our aim in this study was to evaluate whether cooling the eye using topical ice compresses before intravitreal injection will reduce pain or bleeding.
METHODS


This randomized controlled open-label study included 42 patients. All patients received a standard topical anesthesia protocol and then were randomly assigned to either receive a placement of ice packs (intervention group) or a room-temperature pack (control group) on the eyelid, 2 minutes before the intravitreal injection. Patients' discomfort, itching, burning and pain (using visual analog scale), and bleeding size (using photographs) were measured 1 and 10 minutes after the injection. Tolerability was calculated by averaging patients' discomfort, itching, burning, and pain scores.
RESULTS


At 1 minute, pain (1.95 vs. 4.27, P = 0.01) and overall tolerability (1.66 vs. 2.98, P = 0.03) were significantly lower in patients receiving ice packs. At 10 minutes, pain (1.6 vs. 3.73, P = 0.02), burning (0.9 vs. 3.09, P = 0.007), discomfort (2.1 vs. 4.27, P = 0.008), and overall tolerability (1.23 vs. 2.87, P = 0.004) were all significantly lower in the ice group compared with the controls. Bleeding size (area or circumference) was not statistical different between groups.
CONCLUSION


Topical ice patch administered before intravitreal injection significantly decreased pain and overall tolerability. This simple and inexpensive method may be used to ameliorated pain and improve tolerability.",2020,"At 10 minutes, pain (1.6 vs. 3.73, P = 0.02), burning (0.9 vs. 3.09, P = 0.007), discomfort (2.1 vs. 4.27, P = 0.008), and overall tolerability (1.23 vs. 2.87, P = 0.004) were all significantly lower in the ice group compared with the controls.",['42 patients'],"['ICE', 'standard topical anesthesia protocol', 'placement of ice packs (intervention group) or a room-temperature pack (control group']","['discomfort, itching, burning and pain (using visual analog scale), and bleeding size (using photographs', 'Bleeding size (area or circumference', 'pain and improve tolerability', 'pain', 'discomfort', 'pain and overall tolerability', 'discomfort, itching, burning, and pain scores', 'Tolerability', 'overall tolerability', 'pain or bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0349714', 'cui_str': 'Icing (substance)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0181264', 'cui_str': 'Ice bag, device (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0441468', 'cui_str': 'Photograph (physical object)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",42.0,0.0725399,"At 10 minutes, pain (1.6 vs. 3.73, P = 0.02), burning (0.9 vs. 3.09, P = 0.007), discomfort (2.1 vs. 4.27, P = 0.008), and overall tolerability (1.23 vs. 2.87, P = 0.004) were all significantly lower in the ice group compared with the controls.","[{'ForeName': 'Tal', 'Initials': 'T', 'LastName': 'Yahalomi', 'Affiliation': 'Department of Ophthalmology, Assuta Universitary Medical Center, Ashdod, Israel.'}, {'ForeName': 'Idan', 'Initials': 'I', 'LastName': 'Hecht', 'Affiliation': 'Department of Ophthalmology, Edith Wolfson Medical Center, Holon, Israel.'}, {'ForeName': 'Oded', 'Initials': 'O', 'LastName': 'Lagstein', 'Affiliation': 'Department of Ophthalmology, Edith Wolfson Medical Center, Holon, Israel.'}, {'ForeName': 'Achia', 'Initials': 'A', 'LastName': 'Nemet', 'Affiliation': 'Department of Ophthalmology, Edith Wolfson Medical Center, Holon, Israel.'}, {'ForeName': 'Liron', 'Initials': 'L', 'LastName': 'Peʼer', 'Affiliation': 'Department of Ophthalmology, Edith Wolfson Medical Center, Holon, Israel.'}, {'ForeName': 'Fady', 'Initials': 'F', 'LastName': 'Hadad', 'Affiliation': 'Department of Ophthalmology, Edith Wolfson Medical Center, Holon, Israel.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Keren-Yaar', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Rabea', 'Initials': 'R', 'LastName': 'Kassem', 'Affiliation': 'Department of Ophthalmology, Kaplan Medical Center, Rehovot and the Hebrew University of Jerusalem-Hadassah Medical School, Jerusalem, Israel.'}, {'ForeName': 'Zvia', 'Initials': 'Z', 'LastName': 'Burgansky-Eliash', 'Affiliation': 'Department of Ophthalmology, Edith Wolfson Medical Center, Holon, Israel.'}, {'ForeName': 'Asaf', 'Initials': 'A', 'LastName': 'Bar', 'Affiliation': 'Department of Ophthalmology, Edith Wolfson Medical Center, Holon, Israel.'}, {'ForeName': 'Asaf', 'Initials': 'A', 'LastName': 'Achiron', 'Affiliation': 'Department of Ophthalmology, Edith Wolfson Medical Center, Holon, Israel.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002608']
1129,31307869,The Effectiveness of an Evidence-Based Pain Management Program on Pain Intensity and Chest Rehabilitation Improvement Among Chest Trauma Patients in a Thai Hospital.,"BACKGROUND


Pain after thoracic injury has further profound impacts on patients resulting in increased length of hospital stay and hospital care cost, and decreased quality of life. Utilization of the cutting-edge evidence on pain management that fits with the individual care context is therefore important.
AIM


To examine the effects of an evidenced-based pain management program on the worst pain intensity and lung vital capacity among acutely ill hospitalized chest trauma patients.
DESIGN


A two-group repeated measures design.
SETTINGS


trauma unit, a university hospital in southern Thailand.
PARTICIPANTS/SUBJECTS


42 chest trauma patients.
METHODS


The study population included 42 chest trauma patients admitted to the trauma unit. Twenty-one eligible chest trauma patients were consecutively assigned into intervention and control groups. The impacts of the intervention on the level of the worst pain intensity and lung vital capacity were measured before implementation of the program and throughout the first 5 days of admission.
RESULTS


The study found a significant reduction in the worst pain intensity and an increase in the lung vital capacity among chest trauma patients in the intervention group compared with the control group (p < .05).
CONCLUSIONS


Use of a pain management program can be an effective, inexpensive, and low-risk intervention for the improvement of pain management and chest rehabilitation among chest trauma patients.",2019,"The study found a significant reduction in the worst pain intensity and an increase in the lung vital capacity among chest trauma patients in the intervention group compared with the control group (p < .05).
","['42 chest trauma patients admitted to the trauma unit', 'acutely ill hospitalized chest trauma patients', 'chest trauma patients', '42 chest trauma patients', 'trauma unit, a university hospital in southern Thailand', 'Twenty-one eligible chest trauma patients', 'Chest Trauma Patients in a Thai Hospital']","['evidenced-based pain management program', 'Evidence-Based Pain Management Program']","['length of hospital stay and hospital care cost', 'worst pain intensity', 'lung vital capacity', 'level of the worst pain intensity and lung vital capacity', 'Pain Intensity and Chest Rehabilitation Improvement']","[{'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040788', 'cui_str': 'Trauma Units'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0337910', 'cui_str': 'Thai'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]",21.0,0.0178171,"The study found a significant reduction in the worst pain intensity and an increase in the lung vital capacity among chest trauma patients in the intervention group compared with the control group (p < .05).
","[{'ForeName': 'Sahas', 'Initials': 'S', 'LastName': 'Bilalee', 'Affiliation': 'Songklanagarind Hospital, Faculty of Medicine, Prince of Songkla University, Hat-Yai, Thailand. Electronic address: aya_mza@hotmail.com.'}, {'ForeName': 'Khomapak', 'Initials': 'K', 'LastName': 'Maneewat', 'Affiliation': 'Department of Surgical Nursing, Faculty of Nursing, Prince of Songkla University, Hat-Yai, Thailand.'}, {'ForeName': 'Wipa', 'Initials': 'W', 'LastName': 'Sae-Sia', 'Affiliation': 'Department of Surgical Nursing, Faculty of Nursing, Prince of Songkla University, Hat-Yai, Thailand.'}, {'ForeName': 'Sasikaan', 'Initials': 'S', 'LastName': 'Nimmaanrat', 'Affiliation': 'Songklanagarind Hospital, Faculty of Medicine, Prince of Songkla University, Hat-Yai, Thailand.'}]",Pain management nursing : official journal of the American Society of Pain Management Nurses,['10.1016/j.pmn.2019.06.002']
1130,31002442,An internet-delivered cognitive behavioural therapy pain management programme for spinal cord injury pain: A randomized controlled trial.,"BACKGROUND


Chronic pain is common after spinal cord injury (SCI) and dedicated SCI cognitive behavioural therapy pain management programmes (CBT-PMPs) have a growing evidence base to support their uptake clinically. The development of internet-delivered treatment options may overcome barriers to the access and uptake of centre-based programmes. This study examines such an approach on quality of lie (QoL), pain, mood and sleep.
METHODS


Adults with SCI pain (>3 months) were recruited and randomly assigned to the intervention or control group. The intervention comprised a six module CBT-PMP delivered once weekly. A blinded assessor determined changes in self-reported outcome measures post-intervention and at 3 months. Linear mixed models and effect sizes based on changes between groups were reported. Significance was set p < 0.05.
RESULTS


The recruitment rate was 32% (intervention n = 35, control n = 34), and the drop-out rate at 3 months was 26%. On average, participants accessed three (SD 2.1) of six modules. While no difference in QoL was reported, a significant group*time interaction was found for NRS of current pain (χ 2   = 8.22, p = 0.016), worst pain (χ 2   = 11.20, p = 0.004), and Brief Pain Inventory (interference) (χ 2   = 6.924, p = 0.031). Moderate to large effect sizes favouring the intervention were demonstrated at each time point for the pain metrics (Cohen's d: 0.38-0.84). At 3-month follow-up, 48% of the intervention group rated themselves improved or very much improved (p < 0.05).
CONCLUSIONS


This study demonstrates the potential of an internet-delivered SCI specific CBT-PMP in reporting significant statistical and clinical benefit in pain intensity and interference. Strategies to improve engagement are needed.",2019,Moderate to large effect sizes favouring the intervention were demonstrated at each time point for the pain metrics (Cohen's d: 0.38-0.84).,"['spinal cord injury pain', 'Adults with SCI pain (>3\xa0months']","['internet-delivered SCI specific CBT-PMP', 'SCI cognitive behavioural therapy pain management programmes (CBT-PMPs', 'internet-delivered cognitive behavioural therapy pain management programme']","['recruitment rate', 'quality of lie (QoL), pain, mood and sleep', 'worst pain', 'NRS of current pain', 'QoL', 'Brief Pain Inventory (interference']","[{'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0600261', 'cui_str': 'Lying'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",,0.169439,Moderate to large effect sizes favouring the intervention were demonstrated at each time point for the pain metrics (Cohen's d: 0.38-0.84).,"[{'ForeName': 'Dearbhla', 'Initials': 'D', 'LastName': 'Burke', 'Affiliation': 'UCD School of Public Health, Physiotherapy and Sports Science, Health Science Centre, University College Dublin, Dublin 4, Ireland.'}, {'ForeName': 'Olive', 'Initials': 'O', 'LastName': 'Lennon', 'Affiliation': 'UCD School of Public Health, Physiotherapy and Sports Science, Health Science Centre, University College Dublin, Dublin 4, Ireland.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Blake', 'Affiliation': 'UCD School of Public Health, Physiotherapy and Sports Science, Health Science Centre, University College Dublin, Dublin 4, Ireland.'}, {'ForeName': 'Maeve', 'Initials': 'M', 'LastName': 'Nolan', 'Affiliation': 'The Spinal Cord System of Care Team, The National Rehabilitation Hospital, Dun Laoighire, County Dublin, Ireland.'}, {'ForeName': 'Sorcha', 'Initials': 'S', 'LastName': 'Barry', 'Affiliation': 'The Spinal Cord System of Care Team, The National Rehabilitation Hospital, Dun Laoighire, County Dublin, Ireland.'}, {'ForeName': 'Eimear', 'Initials': 'E', 'LastName': 'Smith', 'Affiliation': 'The Spinal Cord System of Care Team, The National Rehabilitation Hospital, Dun Laoighire, County Dublin, Ireland.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Maye', 'Affiliation': 'The Spinal Cord System of Care Team, The National Rehabilitation Hospital, Dun Laoighire, County Dublin, Ireland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lynch', 'Affiliation': 'The Spinal Cord System of Care Team, The National Rehabilitation Hospital, Dun Laoighire, County Dublin, Ireland.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': ""O'Connor"", 'Affiliation': 'The Spinal Cord System of Care Team, The National Rehabilitation Hospital, Dun Laoighire, County Dublin, Ireland.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Maume', 'Affiliation': 'The Spinal Cord System of Care Team, The National Rehabilitation Hospital, Dun Laoighire, County Dublin, Ireland.'}, {'ForeName': 'Sheena', 'Initials': 'S', 'LastName': 'Cheyne', 'Affiliation': 'The Spinal Cord System of Care Team, The National Rehabilitation Hospital, Dun Laoighire, County Dublin, Ireland.'}, {'ForeName': 'Sadb', 'Initials': 'S', 'LastName': 'Ní Ghiollain', 'Affiliation': 'The Spinal Cord System of Care Team, The National Rehabilitation Hospital, Dun Laoighire, County Dublin, Ireland.'}, {'ForeName': 'Brona M', 'Initials': 'BM', 'LastName': 'Fullen', 'Affiliation': 'UCD School of Public Health, Physiotherapy and Sports Science, Health Science Centre, University College Dublin, Dublin 4, Ireland.'}]","European journal of pain (London, England)",['10.1002/ejp.1402']
1131,31251679,Language Training Leads to Global Cognitive Improvement in Older Adults: A Preliminary Study.,"Purpose We report a preliminary study that prospectively tests the potential cognitive enhancing effect of foreign language (FL) learning in older adults with no clear signs of cognitive decline beyond what is age typical. Because language learning engages a large brain network that overlaps with the network of cognitive aging, we hypothesized that learning a new language later in life would be beneficial. Method Older adults were randomly assigned to 3 training groups: FL, games, and music appreciation. All were trained predominately by a computer-based program for 6 months, and their cognitive abilities were tested before, immediately after, and 3 months after training. Results FL and games, but not music appreciation, improved overall cognitive abilities that were maintained at 3 months after training. Conclusion This is the 1st randomized control study providing preliminary support for the cognitive benefits of FL learning.",2019,"Results FL and games, but not music appreciation, improved overall cognitive abilities that were maintained at 3 months after training.","['older adults with no clear signs of cognitive decline beyond what is age typical', 'Method Older adults', 'Older Adults']","['foreign language (FL) learning', 'Language Training']","['Global Cognitive Improvement', 'overall cognitive abilities']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0234985', 'cui_str': 'Cognitive Decline'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0023018', 'cui_str': 'Language Training'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]",,0.0300371,"Results FL and games, but not music appreciation, improved overall cognitive abilities that were maintained at 3 months after training.","[{'ForeName': 'Patrick C M', 'Initials': 'PCM', 'LastName': 'Wong', 'Affiliation': 'Department of Linguistics and Modern Languages, The Chinese University of Hong Kong, China.'}, {'ForeName': 'Jinghua', 'Initials': 'J', 'LastName': 'Ou', 'Affiliation': 'Department of Linguistics and Modern Languages, The Chinese University of Hong Kong, China.'}, {'ForeName': 'Celestina W Y', 'Initials': 'CWY', 'LastName': 'Pang', 'Affiliation': 'Department of Linguistics and Modern Languages, The Chinese University of Hong Kong, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Chinese Language Studies, The Education University of Hong Kong, China.'}, {'ForeName': 'Chi Shing', 'Initials': 'CS', 'LastName': 'Tse', 'Affiliation': 'Department of Educational Psychology, The Chinese University of Hong Kong, China.'}, {'ForeName': 'Linda C W', 'Initials': 'LCW', 'LastName': 'Lam', 'Affiliation': 'Department of Psychiatry, The Chinese University of Hong Kong, China.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Antoniou', 'Affiliation': 'The MARCS Institute for Brain, Behaviour and Development, Western Sydney University, Australia.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2019_JSLHR-L-18-0321']
1132,31291491,The role of high-intensity focused ultrasound as a symptomatic treatment for Parkinson's disease.,"MR-guided focused ultrasound is a novel, minimally invasive surgical procedure for symptomatic treatment of PD. With this technology, the ventral intermediate nucleus, STN, and internal globus pallidus have been targeted for therapeutic cerebral ablation, while also minimizing the risk of hemorrhage and infection from more invasive neurosurgical procedures. In a double-blinded, prospective, sham-controlled randomized controlled trial of MR-guided focused ultrasound thalamotomy for treatment of tremor-dominant PD, 62% of treated patients demonstrated improvement in tremor scores from baseline to 3 months postoperatively, as compared to 22% in the sham group. There has been only one open-label trial of MR-guided focused ultrasound subthalamotomy for patients with PD, demonstrating improvements of 71% for rigidity, 36% for akinesia, and 77% for tremor 6 months after treatment. Among the two open-label trials of MR-guided focused ultrasound pallidotomy for patients with PD, dyskinesia and overall motor scores improved up to 52% and 45% at 6 months postoperatively. Although MR-guided focused ultrasound thalamotomy is now approved by the U.S. Food and Drug Administration for treatment of parkinsonian tremor, additional high-quality randomized controlled trials are warranted and are underway to determine the safety and efficacy of MR-guided focused ultrasound subthalamotomy and pallidotomy for treatment of the cardinal features of PD. These studies will be paramount to aid clinicians to determine the ideal ablative target for individual patients. Additional work will be required to assess the durability of MR-guided focused ultrasound lesions, ideal timing of MR-guided focused ultrasound ablation in the course of PD, and the safety of performing bilateral lesions. © 2019 International Parkinson and Movement Disorder Society.",2019,"There has been only one open-label trial of MR-guided focused ultrasound subthalamotomy for patients with PD, demonstrating improvements of 71% for rigidity, 36% for akinesia, and 77% for tremor 6 months after treatment.","[""Parkinson's disease""]","['MR-guided focused ultrasound pallidotomy', 'MR-guided focused ultrasound thalamotomy', 'MR-guided focused ultrasound']","['dyskinesia and overall motor scores', 'tremor scores']","[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0195893', 'cui_str': 'Pallidotomy'}, {'cui': 'C0195894', 'cui_str': 'Thalamotomy (procedure)'}]","[{'cui': 'C1869094', 'cui_str': 'Dyskinesia (SMQ)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}]",,0.0535059,"There has been only one open-label trial of MR-guided focused ultrasound subthalamotomy for patients with PD, demonstrating improvements of 71% for rigidity, 36% for akinesia, and 77% for tremor 6 months after treatment.","[{'ForeName': 'Shayan', 'Initials': 'S', 'LastName': 'Moosa', 'Affiliation': 'Department of Neurological Surgery, University of Virginia Health System, Charlottesville, Virginia, USA.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Martínez-Fernández', 'Affiliation': 'CINAC (Centro Integral de Neurociencias), University Hospital HM Puerta del Sur, CEU-San Pablo University, Móstoles, Madrid, Spain.'}, {'ForeName': 'W Jeffrey', 'Initials': 'WJ', 'LastName': 'Elias', 'Affiliation': 'Department of Neurological Surgery, University of Virginia Health System, Charlottesville, Virginia, USA.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Del Alamo', 'Affiliation': 'CINAC (Centro Integral de Neurociencias), University Hospital HM Puerta del Sur, CEU-San Pablo University, Móstoles, Madrid, Spain.'}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Eisenberg', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Fishman', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, Maryland, USA.'}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.27779']
1133,31317460,"Apneic Oxygenation During Prolonged Laryngoscopy in Obese Patients: a Randomized, Double-Blinded, Controlled Trial of Nasal Cannula Oxygen Administration.","BACKGROUND


Obese patients have a propensity to desaturate during induction of general anesthesia secondary to their reduced functional residual capacity and increased oxygen consumption. Apneic oxygenation can provide supplemental oxygen to the alveoli, even in the absence of ventilation, during attempts to secure the airway. In this study, we hypothesized that oxygen administration through a nasopharyngeal airway and standard nasal cannula during a simulated prolonged laryngoscopy would significantly prolong the safe apneic duration in obese patients.
METHODS


One hundred thirty-five obese patients undergoing non-emergent surgery requiring general anesthesia were randomized to either the control group or to receive apneic oxygenation with air versus oxygen. All patients underwent a standard intravenous induction. For patients randomized to receive apneic oxygenation, a nasopharyngeal airway and standard nasal cannula were inserted. A simulated prolonged laryngoscopy was performed to determine the duration of the safe apneic period, defined as the beginning of laryngoscopy until the peripheral oxygen saturation (SpO 2 ) reached 95%.
RESULTS


The oxygen group had a median safe apneic duration that was 103 s longer than the control group. The lowest mean SpO 2  value during the induction period was 3.8% higher in the oxygen group compared to the control group. Following intubation, patients in the oxygen group had a mean end tidal carbon dioxide (ETCO 2 ) level that was 3.0 mmHg higher than patients in the control group.
CONCLUSIONS


In obese patients, oxygen insufflation at 15 L/min through a nasopharyngeal airway and standard nasal cannula can significantly increase the safe apneic duration during induction of anesthesia.",2019,The lowest mean SpO 2  value during the induction period was 3.8% higher in the oxygen group compared to the control group.,"['Obese patients', 'Obese Patients', 'obese patients', 'One hundred thirty-five obese patients undergoing non-emergent surgery requiring general anesthesia']","['Nasal Cannula Oxygen Administration', 'apneic oxygenation, a nasopharyngeal airway and standard nasal cannula', 'control group or to receive apneic oxygenation with air versus oxygen']","['mean end tidal carbon dioxide (ETCO 2 ) level', 'Apneic Oxygenation', 'median safe apneic duration', 'safe apneic duration']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}]","[{'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0475745', 'cui_str': 'Apneic oxygenation (procedure)'}, {'cui': 'C0027442', 'cui_str': 'Rhinopharynx'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001861', 'cui_str': 'Air'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0475745', 'cui_str': 'Apneic oxygenation (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",135.0,0.140261,The lowest mean SpO 2  value during the induction period was 3.8% higher in the oxygen group compared to the control group.,"[{'ForeName': 'Tiffany S', 'Initials': 'TS', 'LastName': 'Moon', 'Affiliation': 'University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75390-9068, USA. Tiffany.Moon@UTSouthwestern.edu.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Tai', 'Affiliation': 'University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75390-9068, USA.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Kim', 'Affiliation': 'University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75390-9068, USA.'}, {'ForeName': 'Michael X', 'Initials': 'MX', 'LastName': 'Gonzales', 'Affiliation': 'University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75390-9068, USA.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Lu', 'Affiliation': 'University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75390-9068, USA.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Pak', 'Affiliation': 'University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75390-9068, USA.'}, {'ForeName': 'Katelynn', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75390-9068, USA.'}, {'ForeName': 'Joy L', 'Initials': 'JL', 'LastName': 'Chen', 'Affiliation': 'University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75390-9068, USA.'}, {'ForeName': 'Abu T', 'Initials': 'AT', 'LastName': 'Minhajuddin', 'Affiliation': 'University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75390-9068, USA.'}, {'ForeName': 'Nwamaka', 'Initials': 'N', 'LastName': 'Nnamani', 'Affiliation': 'University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75390-9068, USA.'}, {'ForeName': 'Pamela E', 'Initials': 'PE', 'LastName': 'Fox', 'Affiliation': 'University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75390-9068, USA.'}, {'ForeName': 'Babatunde', 'Initials': 'B', 'LastName': 'Ogunnaike', 'Affiliation': 'University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75390-9068, USA.'}]",Obesity surgery,['10.1007/s11695-019-04077-y']
1134,31306043,Icosapent ethyl reduces atherogenic markers in high-risk statin-treated patients with stage 3 chronic kidney disease and high triglycerides.,"Objective : Patients with chronic kidney disease (CKD) have increased cardiovascular disease (CVD) risk, likely driven by atherogenic and inflammatory markers beyond low-density lipoprotein cholesterol (LDL-C). The objective of this hypothesis-generating post hoc subgroup analysis was to explore the effects of icosapent ethyl at 2 or 4 g/day (prescription pure ethyl ester of the omega-3 fatty acid eicosapentaenoic acid [EPA]) on atherogenic lipid, apolipoprotein, inflammatory parameters (high-sensitivity C-reactive protein [hsCRP], lipoprotein-associated phospholipase A 2  [Lp-PLA 2 ]), and oxidative parameters (oxidized-LDL [ox-LDL]) in statin-treated patients from ANCHOR with stage 3 CKD. Methods : The 12-week ANCHOR study evaluated icosapent ethyl in 702 statin-treated patients at increased CVD risk with triglycerides (TG) 200-499 mg/dL despite controlled LDL-C (40-99 mg/dL). This post-hoc analysis included patients from ANCHOR with stage 3 CKD (estimated glomerular filtration rate [eGFR] ≤60 mL/min/1.73 m 2  for ≥3 months) randomized to icosapent ethyl 4 g/day (n = 19), 2 g/day (n = 30), or placebo (n = 36). Results : At the prescription dose of 4 g/day, icosapent ethyl significantly reduced TG (-16.9%;  P  = 0.0074) and other potentially atherogenic lipids/lipoproteins, ox-LDL, hsCRP, and Lp-PLA 2 , and increased plasma and red blood cell EPA levels (+879% and +579%, respectively; both  P  < 0.0001) versus placebo. Icosapent ethyl did not significantly alter eGFR or serum creatinine. Safety and tolerability were similar to placebo. Conclusions : In patients with stage 3 CKD at high CVD risk with persistent high TG despite statins, icosapent ethyl 4 g/day reduced potentially atherogenic and other cardiovascular risk factors without raising LDL-C, with safety similar to placebo. These findings suggest prospective investigation may be warranted.",2019,Icosapent ethyl did not significantly alter eGFR or serum creatinine.,"['patients from ANCHOR with stage 3 CKD (estimated glomerular filtration rate [eGFR', 'Objective : Patients with chronic kidney disease (CKD', '≤60', 'statin-treated patients from ANCHOR with stage 3 CKD', '702 statin-treated patients at increased CVD risk with triglycerides (TG', 'high-risk statin-treated patients with stage 3 chronic kidney disease and high triglycerides']","['Icosapent ethyl', 'placebo', 'icosapent ethyl at 2 or 4\xa0g/day (prescription pure ethyl ester of the omega-3 fatty acid eicosapentaenoic acid [EPA']","['TG', 'eGFR or serum creatinine', 'atherogenic markers', 'potentially atherogenic lipids/lipoproteins, ox-LDL, hsCRP, and Lp-PLA 2 , and increased plasma and red blood cell EPA levels', 'atherogenic lipid, apolipoprotein, inflammatory parameters (high-sensitivity C-reactive protein [hsCRP], lipoprotein-associated phospholipase A 2  [Lp-PLA 2 ]), and oxidative parameters (oxidized-LDL [ox-LDL', 'Safety and tolerability', 'cardiovascular disease (CVD) risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C3811844'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0058978', 'cui_str': 'icosapent ethyl'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439417', 'cui_str': 'g/day'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C3884644', 'cui_str': '(trimethylsilyl)ethyl ester'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}]","[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0348035', 'cui_str': 'oxidized low density lipoprotein'}, {'cui': 'C0914069', 'cui_str': '1-Alkyl-2-acetylglycerophosphocholine Esterase'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0523476', 'cui_str': 'Apolipoprotein measurement (procedure)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0031672', 'cui_str': 'Phospholipases A'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",702.0,0.356039,Icosapent ethyl did not significantly alter eGFR or serum creatinine.,"[{'ForeName': 'Krishnaswami', 'Initials': 'K', 'LastName': 'Vijayaraghavan', 'Affiliation': 'Institute of Congestive Heart Failure, Abrazo Arizona Heart Hospital, Phoenix, AZ, USA.'}, {'ForeName': 'Harold M', 'Initials': 'HM', 'LastName': 'Szerlip', 'Affiliation': 'Nephrology Division and Nephrology Fellowship Program, Baylor University Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Christie M', 'Initials': 'CM', 'LastName': 'Ballantyne', 'Affiliation': 'Department of Medicine, Baylor College of Medicine and the Houston Methodist DeBakey Heart and Vascular Center, Houston, TX, USA.'}, {'ForeName': 'Harold E', 'Initials': 'HE', 'LastName': 'Bays', 'Affiliation': 'Louisville Metabolic and Atherosclerosis Research Center, Louisville, KY, USA.'}, {'ForeName': 'Sephy', 'Initials': 'S', 'LastName': 'Philip', 'Affiliation': 'Medical Affairs, Amarin Pharma Inc., Bedminster, NJ, USA.'}, {'ForeName': 'Ralph T', 'Initials': 'RT', 'LastName': 'Doyle', 'Affiliation': 'Clinical Development, Amarin Pharma Inc., Bedminster, NJ, USA.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Juliano', 'Affiliation': 'Clinical Development, Amarin Pharma Inc., Bedminster, NJ, USA.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Granowitz', 'Affiliation': 'Medical Affairs, Amarin Pharma Inc., Bedminster, NJ, USA.'}]",Postgraduate medicine,['10.1080/00325481.2019.1643633']
1135,31284771,"Efficacy and safety of mirogabalin for the treatment of fibromyalgia: results from three 13-week randomized, double-blind, placebo- and active-controlled, parallel-group studies and a 52-week open-label extension study.","Objective:  To investigate the efficacy and safety of mirogabalin, an α 2 δ ligand, in patients with fibromyalgia (FM).  Methods:  In three 13-week, multicenter, double-blind, phase 3 studies (studies A, B, and C), patients with FM ( n  = 1293, 1270, and 1301, respectively) were randomized (1:1:1:1) to placebo, pregabalin 150 mg twice daily, mirogabalin 15 mg once daily or mirogabalin 15 mg twice daily. The primary endpoint was the change in weekly average daily worst pain score (ADPS) at week 13. Key secondary endpoints included Patient Global Impression of Change and change in the Fibromyalgia Impact Questionnaire total score. Long-term safety of mirogabalin was assessed in a 52-week extension study.  Results:  Neither mirogabalin dose demonstrated a significant ADPS reduction from baseline vs. placebo at week 13 in any of the three studies. Pregabalin significantly reduced ADPS from baseline vs. placebo in studies B and C ( p  = .0008 and .0001, respectively). The effect of mirogabalin compared with placebo on key secondary endpoints was variable across the studies. Mirogabalin was well tolerated by most patients in the phase 3 studies; no unexpected adverse events occurring during the 52-week extension study.  Conclusion:  While both mirogabalin doses were well tolerated by most patients and showed potential for reducing pain associated with FM, the primary endpoint of significant pain reduction in patients on mirogabalin compared with placebo was not achieved in any of the three randomized controlled studies.  Clinical trial registration:  NCT02146430; NCT02187159; NCT02187471; and NCT02234583 (extension study).",2019,"Pregabalin significantly reduced ADPS from baseline vs. placebo in studies B and C ( p  = .0008 and .0001, respectively).","['fibromyalgia', 'patients with fibromyalgia (FM', 'patients with FM ( n \u2009=\u20091293, 1270, and 1301, respectively']","['Pregabalin', 'placebo, pregabalin 150\u2009mg twice daily, mirogabalin 15\u2009mg once daily or mirogabalin 15\u2009mg twice daily', 'placebo', 'mirogabalin']","['tolerated', 'pain reduction', 'change in weekly average daily worst pain score (ADPS', 'adverse events', 'Patient Global Impression of Change and change in the Fibromyalgia Impact Questionnaire total score', 'ADPS reduction', 'ADPS', 'Efficacy and safety']","[{'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1658524', 'cui_str': 'pregabalin 150 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C4043827', 'cui_str': 'mirogabalin'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.659109,"Pregabalin significantly reduced ADPS from baseline vs. placebo in studies B and C ( p  = .0008 and .0001, respectively).","[{'ForeName': 'Lesley M', 'Initials': 'LM', 'LastName': 'Arnold', 'Affiliation': ""Women's Health Research Program, University of Cincinnati College of Medicine , Cincinnati , OH , USA.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Whitaker', 'Affiliation': 'Daiichi Sankyo Inc. , Basking Ridge , NJ , USA.'}, {'ForeName': 'Ching', 'Initials': 'C', 'LastName': 'Hsu', 'Affiliation': 'Daiichi Sankyo Inc. , Basking Ridge , NJ , USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jacobs', 'Affiliation': 'Daiichi Sankyo Inc. , Basking Ridge , NJ , USA.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Merante', 'Affiliation': 'Global Clinical Development, Daiichi Sankyo Development , Gerrards Cross , United Kingdom.'}]",Current medical research and opinion,['10.1080/03007995.2019.1629757']
1136,31315908,"Oral levosimendan in amyotrophic lateral sclerosis: a phase II multicentre, randomised, double-blind, placebo-controlled trial.","OBJECTIVE


To evaluate the efficacy and safety of oral levosimendan in patients with amyotrophic lateral sclerosis (ALS). This phase II, randomised, double-blind, placebo-controlled, crossover, three-period study with 6 months open-label follow-up enrolled adults with ALS and sitting slow vital capacity (SVC) 60%-90 % of predicted from 11 sites in four countries.
METHODS


Patients received levosimendan 1 mg daily, 1 mg two times a day or placebo during three 14-day crossover periods and levosimendan 1-2 mg daily during open-label follow-up. Primary endpoint was sitting SVC; secondary endpoints included supine SVC, ALS Functional Rating Scale-Revised (ALSFRS-R), tolerability and safety.
RESULTS


Of 66 patients randomised, 59 contributed to the double-blind results and 50 entered open-label follow-up. Sitting SVC was not significantly different between the treatments. In post hoc analysis using period-wise baselines, supine SVC favoured levosimendan over placebo, estimated mean differences from baseline being -3.62% on placebo, +0.77% on levosimendan 1 mg daily (p=0.018) and +2.38% on 1 mg two times a day (p=0.001). Headache occurred in 16.7% of patients during levosimendan 1 mg daily (p=0.030), 28.6% during 1 mg two times a day (p=0.002) and 3.3% during placebo. The respective frequencies for increased heart rate were 5.1% (p=0.337), 18.5% (p=0.018) and 1.7%. No significant differences between the treatments were seen for other adverse events.
CONCLUSIONS


Levosimendan did not achieve the primary endpoint of improving sitting SVC in ALS. Headache and increased heart rate were increased on levosimendan, although it was otherwise well tolerated. A phase III study to evaluate the longer term effects of oral levosimendan in ALS is ongoing.",2019,"Headache occurred in 16.7% of patients during levosimendan 1 mg daily (p=0.030), 28.6% during 1 mg two times a day (p=0.002) and 3.3% during placebo.","['up enrolled adults with ALS and sitting slow vital capacity (SVC) 60%-90 % of predicted from 11 sites in four countries', 'amyotrophic lateral sclerosis', '66 patients randomised', 'patients with amyotrophic lateral sclerosis (ALS']","['oral levosimendan', 'Oral levosimendan', '6 months open-label follow', 'levosimendan', 'placebo', 'Levosimendan', 'levosimendan 1\u2009mg daily, 1\u2009mg two times a day or placebo']","['Sitting SVC', 'tolerated', 'Headache', 'heart rate', 'efficacy and safety', 'Headache and increased heart rate', 'sitting SVC; secondary endpoints included supine SVC, ALS Functional Rating Scale-Revised (ALSFRS-R), tolerability and safety', 'sitting SVC']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0231957', 'cui_str': 'Slow vital capacity (observable entity)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0002736', 'cui_str': 'ALS (Amyotrophic Lateral Sclerosis)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0246904', 'cui_str': 'Levosimendan'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0222045'}]",59.0,0.557233,"Headache occurred in 16.7% of patients during levosimendan 1 mg daily (p=0.030), 28.6% during 1 mg two times a day (p=0.002) and 3.3% during placebo.","[{'ForeName': 'Ammar', 'Initials': 'A', 'LastName': 'Al-Chalabi', 'Affiliation': ""Department of Basic and Clinical Neuroscience, King's College London, Maurice Wohl Clinical Neuroscience Institute, London, UK.""}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Shaw', 'Affiliation': 'Sheffield Institute for Translational Neuroscience and NIHR Sheffield Biomedical Research Centre, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'P Nigel', 'Initials': 'PN', 'LastName': 'Leigh', 'Affiliation': 'Department of Neuroscience Brighton and Sussex Medical School, Trafford Centre for Biomedical Science, Falmer, Brighton, UK.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'van den Berg', 'Affiliation': 'Departmentof Neurology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Orla', 'Initials': 'O', 'LastName': 'Hardiman', 'Affiliation': 'Academic Unit of Neurology, Trinity Biomedical Sciences Institute, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Ludolph', 'Affiliation': 'Department of Neurology, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Valtteri V', 'Initials': 'VV', 'LastName': 'Aho', 'Affiliation': 'Orion Pharma, Orion Corporation, Turku, Finland valtteri.aho@orionpharma.com.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Sarapohja', 'Affiliation': 'Orion Pharma, Orion Corporation, Espoo, Finland.'}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Kuoppamäki', 'Affiliation': 'Orion Pharma, Orion Corporation, Turku, Finland.'}]","Journal of neurology, neurosurgery, and psychiatry",['10.1136/jnnp-2018-320288']
1137,31310989,Effects of a Combined Upper- and Lower-Limb Plyometric Training Program on High-Intensity Actions in Female U14 Handball Players.,"PURPOSE


To analyze the effects of a 9-week plyometric training program on the sprint times (5, 10, 20, and 30 m), change-of-direction speed (modified T test and modified Illinois test), jumping (squat jump, countermovement jump, countermovement jump with arms, and horizontal 5-jump test), upper-body strength (right and left handgrip, back extensor strength, and medicine ball throw), and balance (Y and stork balance tests) of female handball players.
METHODS


Athletes were randomly divided into experimental (n = 21; age = 13.5 [0.3] y) and control (n = 20; age = 13.3 [0.3] y) groups. Training exercises and matches were performed together, but the experimental group replaced a part of their normal regimen by biweekly upper- and lower-limb plyometric training.
RESULTS


Both groups improved performance, but to a greater extent in the experimental group compared with controls for 20- and 30-m sprint times (Δ% = 9.6, P < .05, d = 0.557 and Δ% = 20.9, P < .001, d = 1.07, respectively), change of direction (T test: P < .01, Δ% = 14.5, d = 0.993 and Illinois test: P < .01, Δ% = 7.9, d = 0.769), vertical and horizontal jumping (P < .05), all measures of upper-limb strength (P < .001), and left-leg stork balance (P < .001, Δ% = 49.9, d = 1.07).
CONCLUSIONS


A plyometric training program allows female junior handball players to improve important components of their physical performance.",2019,"Both groups improved performance, but to a greater extent in the experimental group compared with controls for 20- and 30-m sprint times (Δ% = 9.6, P < .05, d = 0.557 and Δ% = 20.9, P < .001, d = 1.07, respectively), change of direction (T test: P < .01, Δ% = 14.5, d = 0.993 and Illinois test: P < .01, Δ% = 7.9, d = 0.769), vertical and horizontal jumping (P < .05), all measures of upper-limb strength (P < .001), and left-leg stork balance (P < .001, Δ% = 49.9, d = 1.07).
","['Female U14 Handball Players', 'female junior handball players', 'Athletes were randomly divided into experimental (n = 21; age = 13.5 [0.3]\xa0y) and control (n = 20; age = 13.3 [0.3] y) groups']","['plyometric training program', 'experimental group replaced a part of their normal regimen by biweekly upper- and lower-limb plyometric training', 'Combined Upper- and Lower-Limb Plyometric Training Program']","['left-leg stork balance', 'change of direction', 'vertical and horizontal jumping', 'upper-limb strength', 'change-of-direction speed (modified T test and modified Illinois test), jumping (squat jump, countermovement jump, countermovement jump with arms, and horizontal 5-jump test), upper-body strength (right and left handgrip, back extensor strength, and medicine ball throw), and balance (Y and stork balance tests) of female handball players']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0336936', 'cui_str': 'Handball'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517559', 'cui_str': '13.5 (qualifier value)'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C3178799', 'cui_str': 'Plyometric Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0325459', 'cui_str': 'Stork'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439755', 'cui_str': 'Directions (qualifier value)'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0205126', 'cui_str': 'Horizontal (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C1268087', 'cui_str': 'Upper body'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0560512', 'cui_str': 'Does throw (finding)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0336936', 'cui_str': 'Handball'}]",,0.00907494,"Both groups improved performance, but to a greater extent in the experimental group compared with controls for 20- and 30-m sprint times (Δ% = 9.6, P < .05, d = 0.557 and Δ% = 20.9, P < .001, d = 1.07, respectively), change of direction (T test: P < .01, Δ% = 14.5, d = 0.993 and Illinois test: P < .01, Δ% = 7.9, d = 0.769), vertical and horizontal jumping (P < .05), all measures of upper-limb strength (P < .001), and left-leg stork balance (P < .001, Δ% = 49.9, d = 1.07).
","[{'ForeName': 'Mehrez', 'Initials': 'M', 'LastName': 'Hammami', 'Affiliation': 'University of ""La Manouba"".'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Ramirez-Campillo', 'Affiliation': 'Universidad de Los Lagos.'}, {'ForeName': 'Nawel', 'Initials': 'N', 'LastName': 'Gaamouri', 'Affiliation': 'University of ""La Manouba"".'}, {'ForeName': 'Gaith', 'Initials': 'G', 'LastName': 'Aloui', 'Affiliation': 'University of ""La Manouba"".'}, {'ForeName': 'Roy J', 'Initials': 'RJ', 'LastName': 'Shephard', 'Affiliation': 'University of Toronto.'}, {'ForeName': 'Mohamed Souhaiel', 'Initials': 'MS', 'LastName': 'Chelly', 'Affiliation': 'University of ""La Manouba"".'}]",Pediatric exercise science,['10.1123/pes.2018-0278']
1138,31307814,Near-infrared fluorescence imaging improves the nodal yield in neck dissection in oral cavity cancer - A randomized study.,"INTRODUCTION


Lymph node yield (LNY) in neck dissection has been identified as a prognostic factor in oral cavity cancer. The purpose of this study was to investigate the impact of additional use of optical imaging on LNY in therapeutic ND in oral cancer.
METHODS


Consecutive patients with oral squamous cell carcinoma with clinical neck metastasis planned for primary tumor resection were randomized to conventional neck dissection or near-infrared fluorescence (NIRF)-guided neck dissection, respectively. In the intervention group, patients were injected with ICG-Nanocoll prior to surgery. Intraoperatively, an optical hand-held camera system was used for lymph node identification. Also, NIRF imaging of the neck specimen was performed, and optical signals were pinned with needle markings to guide the pathological examination. The endpoint of the study was LNY per neck side in levels Ib-III.
RESULTS


31 patients were included with 18 neck sides in the control group and 18 neck sides in the intervention group for evaluation. During NIRF-guided ND, individual lymph nodes could be identified by a bright fluorescent signal and individual tumor-related drainage patterns could be observed in the neck. The LNY in the intervention group was significantly higher compared to the control group (p = 0.032) with a mean of 24 LN (range: 12-33 LN in levels Ib-III compared to 18 LN (range: 10-36 LN) in the control group, respectively.
CONCLUSIONS


NIRF-guided ND significantly improved the nodal yield compared to the control group. Intraoperative real-time optical imaging enabled direct visualization of tumor-related drainage patterns within the neck lymphatics.",2019,"The LNY in the intervention group was significantly higher compared to the control group (p = 0.032) with a mean of 24 LN (range: 12-33 LN in levels Ib-III compared to 18 LN (range: 10-36 LN) in the control group, respectively.
","['31 patients were included with 18 neck sides in the control group and 18 neck sides in the intervention group for evaluation', 'Consecutive patients with oral squamous cell carcinoma with clinical neck metastasis planned for primary tumor resection']","['optical imaging on LNY', 'ICG-Nanocoll prior to surgery', 'conventional neck dissection or near-infrared fluorescence (NIRF)-guided neck dissection, respectively']","['nodal yield', 'LNY per neck side in levels Ib-III']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0441987', 'cui_str': 'Side (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0007137', 'cui_str': 'Carcinoma, Planocellular'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0247623', 'cui_str': 'nanocoll'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0398395', 'cui_str': 'Neck Dissection'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}]",36.0,0.029562,"The LNY in the intervention group was significantly higher compared to the control group (p = 0.032) with a mean of 24 LN (range: 12-33 LN in levels Ib-III compared to 18 LN (range: 10-36 LN) in the control group, respectively.
","[{'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Christensen', 'Affiliation': 'Department of Otolaryngology, Head & Neck Surgery and Audiology, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, DK-2100, Copenhagen East, Denmark; Department of Clinical Physiology, Nuclear Medicine & PET and Cluster for Molecular Imaging, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, DK-2100, Copenhagen East, Denmark. Electronic address: anders.christensen.03@regionh.dk.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Juhl', 'Affiliation': 'Department of Clinical Physiology, Nuclear Medicine & PET and Cluster for Molecular Imaging, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, DK-2100, Copenhagen East, Denmark. Electronic address: karina.juhl@sund.ku.dk.'}, {'ForeName': 'Katalin', 'Initials': 'K', 'LastName': 'Kiss', 'Affiliation': 'Department of Pathology, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, DK-2100, Copenhagen East, Denmark. Electronic address: katalin.kiss@regionh.dk.'}, {'ForeName': 'Giedrius', 'Initials': 'G', 'LastName': 'Lelkaitis', 'Affiliation': 'Department of Pathology, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, DK-2100, Copenhagen East, Denmark. Electronic address: giedrius.lelkaitis@regionh.dk.'}, {'ForeName': 'Birgitte Wittenborg', 'Initials': 'BW', 'LastName': 'Charabi', 'Affiliation': 'Department of Otolaryngology, Head & Neck Surgery and Audiology, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, DK-2100, Copenhagen East, Denmark. Electronic address: birgitte.wittenborg.charabi@regionh.dk.'}, {'ForeName': 'Jann', 'Initials': 'J', 'LastName': 'Mortensen', 'Affiliation': 'Department of Clinical Physiology, Nuclear Medicine & PET and Cluster for Molecular Imaging, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, DK-2100, Copenhagen East, Denmark. Electronic address: jann.mortensen@regionh.dk.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kjær', 'Affiliation': 'Department of Clinical Physiology, Nuclear Medicine & PET and Cluster for Molecular Imaging, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, DK-2100, Copenhagen East, Denmark. Electronic address: andreas.kjaer@regionh.dk.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'von Buchwald', 'Affiliation': 'Department of Otolaryngology, Head & Neck Surgery and Audiology, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, DK-2100, Copenhagen East, Denmark. Electronic address: christian.von.buchwald@regionh.dk.'}]",European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology,['10.1016/j.ejso.2019.06.039']
1139,31296491,"NBTXR3, a first-in-class radioenhancer hafnium oxide nanoparticle, plus radiotherapy versus radiotherapy alone in patients with locally advanced soft-tissue sarcoma (Act.In.Sarc): a multicentre, phase 2-3, randomised, controlled trial.","BACKGROUND


Pathological complete response to preoperative treatment in adults with soft-tissue sarcoma can be achieved in only a few patients receiving radiotherapy. This phase 2-3 trial evaluated the safety and efficacy of the hafnium oxide (HfO 2 ) nanoparticle NBTXR3 activated by radiotherapy versus radiotherapy alone as a pre-operative treatment in patients with locally advanced soft-tissue sarcoma.
METHODS


Act.In.Sarc is a phase 2-3 randomised, multicentre, international trial. Adults (aged ≥18 years) with locally advanced soft-tissue sarcoma of the extremity or trunk wall, of any histological grade, and requiring preoperative radiotherapy were included. Patients had to have a WHO performance status of 0-2 and a life expectancy of at least 6 months. Patients were randomly assigned (1:1) by an interactive web response system to receive either NBTXR3 (volume corresponding to 10% of baseline tumour volume at a fixed concentration of 53·3 g/L) as a single intratumoural administration before preoperative external-beam radiotherapy (50 Gy in 25 fractions) or radiotherapy alone, followed by surgery. Randomisation was stratified by histological subtype (myxoid liposarcoma vs others). This was an open-label study. The primary endpoint was the proportion of patients with a pathological complete response, assessed by a central pathology review board following European Organisation for Research and Treatment of Cancer guidelines in the intention-to-treat population full analysis set. Safety analyses were done in all patients who received at least one puncture and injection of NBTXR3 or at least one dose of radiotherapy. This study is registered with ClinicalTrials.gov, number NCT02379845, and is ongoing for long-term follow-up, but recruitment is complete.
FINDINGS


Between March 3, 2015, and Nov 21, 2017, 180 eligible patients were enrolled and randomly assigned and 179 started treatment: 89 in the NBTXR3 plus radiotherapy group and 90 in the radiotherapy alone group. Two patients in the NBTXR3 group and one patient in the radiotherapy group were excluded from the efficacy analysis because they were subsequently discovered to be ineligible; thus, a total of 176 patients were analysed for the primary endpoint in the intention-to-treat full analysis set (87 in the NBTXR3 group and 89 in the radiotherapy alone group). A pathological complete response was noted in 14 (16%) of 87 patients in the NBTXR3 group and seven (8%) of 89 in the radiotherapy alone group (p=0·044). In both treatment groups, the most common grade 3-4 treatment-emergent adverse event was postoperative wound complication (eight [9%] of 89 patients in the NBTXR3 group and eight [9%] of 90 in the radiotherapy alone group). The most common grade 3-4 adverse events related to NBTXR3 administration were injection site pain (four [4%] of 89) and hypotension (four [4%]) and the most common grade 3-4 radiotherapy-related adverse event was radiation skin injury in both groups (five [6%] of 89 in the NBTXR3 group and four [4%] of 90 in the radiotherapy alone group). The most common treatment-emergent grade 3-4 adverse event related to NBTXR3 was hypotension (six [7%] of 89 patients). Serious adverse events were observed in 35 (39%) of 89 patients in the NBTXR3 group and 27 (30%) of 90 patients in the radiotherapy alone group. No treatment-related deaths occurred.
INTERPRETATION


This trial validates the mode of action of this new class of radioenhancer, which potentially opens a large field of clinical applications in soft-tissue sarcoma and possibly other cancers.
FUNDING


Nanobiotix SA.",2019,A pathological complete response was noted in 14 (16%) of 87 patients in the NBTXR3 group and seven (8%) of 89 in the radiotherapy alone group (p=0·044).,"['adults with soft-tissue sarcoma', 'Adults (aged ≥18 years) with locally advanced soft-tissue sarcoma of the extremity or trunk wall, of any histological grade, and requiring preoperative radiotherapy were included', 'patients with locally advanced soft-tissue sarcoma (Act', 'patients with locally advanced soft-tissue sarcoma', 'Between March 3, 2015, and Nov 21, 2017, 180 eligible patients were enrolled and randomly assigned and 179 started treatment: 89 in the', 'Patients had to have a WHO performance status of 0-2 and a life expectancy of at least 6 months']","['radiotherapy versus radiotherapy alone', 'NBTXR3 plus radiotherapy', 'NBTXR3', 'radiotherapy', 'hafnium oxide (HfO 2 ) nanoparticle NBTXR3 activated by radiotherapy versus radiotherapy alone']","['postoperative wound complication', 'proportion of patients with a pathological complete response, assessed by a central pathology review board following European Organisation for Research and Treatment of Cancer guidelines', 'hypotension', 'Serious adverse events', 'pathological complete response', 'injection site pain', 'safety and efficacy']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4551687', 'cui_str': 'Sarcoma of soft tissue (disorder)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0456201', 'cui_str': 'Histological grades (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517609', 'cui_str': '179 (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2742307', 'cui_str': 'hafnium oxide'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}]","[{'cui': 'C0877305', 'cui_str': 'Postoperative wound complication'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C0035168'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",180.0,0.171668,A pathological complete response was noted in 14 (16%) of 87 patients in the NBTXR3 group and seven (8%) of 89 in the radiotherapy alone group (p=0·044).,"[{'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Bonvalot', 'Affiliation': 'Department of Surgery, Institut Curie, PSL Research University, Paris, France. Electronic address: sylvie.bonvalot@curie.fr.'}, {'ForeName': 'Piotr L', 'Initials': 'PL', 'LastName': 'Rutkowski', 'Affiliation': 'Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie Institute-Oncology Center, Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Thariat', 'Affiliation': 'Department of Radiation Oncology, Centre François Baclesse, Caen, France; Department of Radiation Oncology, Centre Lacassagne, Nice, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Carrère', 'Affiliation': 'Department of Surgical Oncology, Centre Regional De Lutte Contre Le Cancer Paul Lamarque, Montpellier, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Ducassou', 'Affiliation': 'Department of Radiation Oncology, Institut Claudius Regaud (ICR), Institut Universitaire du Cancer de Toulouse-Oncopole (IUCT-O), Toulouse, France.'}, {'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'Sunyach', 'Affiliation': 'Department of Radiotherapy, Léon Bérard Cancer Center, Lyon, France.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Agoston', 'Affiliation': 'Department of Radiation Oncology, Országos Onkologiai Intézet, Budapest, Hungary.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Hong', 'Affiliation': ""Department of Radiation Oncology, Chris O'Brien Lifehouse and The University of Sydney, Camperdown, NSW, Australia.""}, {'ForeName': 'Augustin', 'Initials': 'A', 'LastName': 'Mervoyer', 'Affiliation': ""Department of Radiation Oncology, Institut de Cancerologie de l'Ouest- Rene Gauducheau, Saint-Herblain, France.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Rastrelli', 'Affiliation': 'Department of Surgical Oncology, Istituto Oncologico Veneto IRCCS, Padova, Italy.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Moreno', 'Affiliation': 'Department of Medical Oncology, Hospital Fundación Jimenez Diaz, Madrid, Spain.'}, {'ForeName': 'Rubi K', 'Initials': 'RK', 'LastName': 'Li', 'Affiliation': ""Department of Medical Oncology, St Luke's Medical Center, Quezon City, Philippines.""}, {'ForeName': 'Béatrice', 'Initials': 'B', 'LastName': 'Tiangco', 'Affiliation': 'Department of Medical Oncology, The Medical City Cancer Center, Pasay City, Philippines.'}, {'ForeName': 'Antonio Casado', 'Initials': 'AC', 'LastName': 'Herraez', 'Affiliation': 'Department of Medical Oncology, Hospital Clinico Universitario San Carlos, Madrid, Spain.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Gronchi', 'Affiliation': 'Department of Surgery, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.'}, {'ForeName': 'László', 'Initials': 'L', 'LastName': 'Mangel', 'Affiliation': 'Department of Oncotherapy, University of Pecs, Pecs, Hungary.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Sy-Ortin', 'Affiliation': 'Department of Radiation Oncology, Benavides Cancer Institute, University of Santo Tomas Hospital, Manila, Philippines.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hohenberger', 'Affiliation': 'Department of Surgery, Division of Surgical Oncology and Thoracic Surgery, University Hospital Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'de Baère', 'Affiliation': 'Department of Interventional Radiology, Gustave Roussy-Cancer Campus, Villejuif, France.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Le Cesne', 'Affiliation': 'Department of Medical Oncology, Gustave Roussy-Cancer Campus, Villejuif, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Helfre', 'Affiliation': 'Department of Radiation Therapy, Institut Curie, PSL Research University, Paris, France.'}, {'ForeName': 'Esma', 'Initials': 'E', 'LastName': 'Saada-Bouzid', 'Affiliation': 'Department of Medical Oncology, Centre Anticancer Antoine Lacassagne, Nice, France.'}, {'ForeName': 'Aneta', 'Initials': 'A', 'LastName': 'Borkowska', 'Affiliation': 'Department of Radiotherapy, Maria Sklodowska-Curie Institute-Oncology Center, Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'Rodica', 'Initials': 'R', 'LastName': 'Anghel', 'Affiliation': 'Institutul Oncologic Bucuresti Prof Dr Alexandru Trestioreanu, Bucharest, Romania.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Co', 'Affiliation': 'Cebu Cancer Institute, Perpetual Succour Hospital, Cebu City, Philippines.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gebhart', 'Affiliation': 'Department of Orthopedic Surgery, ULB, Institut Jules Bordet, Brussels, Belgium.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Kantor', 'Affiliation': 'Department of Radiotherapy, Institut Bergonié, Comprehensive Cancer Center, Bordeaux, France.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Montero', 'Affiliation': 'Radiation Oncology Department, Hospital HM Universitario Sanchinarro, Madrid, Spain.'}, {'ForeName': 'Herbert H', 'Initials': 'HH', 'LastName': 'Loong', 'Affiliation': 'Department of Clinical Oncology, Prince of Wales Hospital, Sha Tin, Hong Kong.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Vergés', 'Affiliation': ""Radiation Oncology Department, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Lore', 'Initials': 'L', 'LastName': 'Lapeire', 'Affiliation': 'Department of Medical Oncology, Ghent University Hospital, Gent, Belgium.'}, {'ForeName': 'Sorin', 'Initials': 'S', 'LastName': 'Dema', 'Affiliation': 'Municipal Emergency Hospital Timisoara, Timisoara, Romania.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Kacso', 'Affiliation': 'Iuliu Hatieganu Medical University, RTC Amethyst, Cluj, Romania.'}, {'ForeName': 'Lyn', 'Initials': 'L', 'LastName': 'Austen', 'Affiliation': 'Department of Radiation Oncology, Canberra Region Cancer Centre, Garran, Australia.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Moureau-Zabotto', 'Affiliation': 'Department of Radiation-Oncology, Institut Paoli Calmettes, Marseille Cedex, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Servois', 'Affiliation': 'Department of Radiology, Institut Curie, PSL Research University, Paris, France.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Wardelmann', 'Affiliation': 'Gerhard Domagk Institute of Pathology, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Terrier', 'Affiliation': 'Gustave Roussy, Cancer Campus, Paris-Sud University, Villejuif, France.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Lazar', 'Affiliation': 'Departments of Pathology & Genomic Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Judith V M G', 'Initials': 'JVMG', 'LastName': 'Bovée', 'Affiliation': 'Department of Pathology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Le Péchoux', 'Affiliation': 'Department of Radiation Oncology, Gustave Roussy-Cancer Campus, Villejuif, France.'}, {'ForeName': 'Zsusanna', 'Initials': 'Z', 'LastName': 'Papai', 'Affiliation': 'Medical Centre, Hungarian Defence Forces, Budapest, Hungary.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30326-2']
1140,31280100,Erector spinae plane block and thoracic paravertebral block for breast surgery compared to IV-morphine: A randomized controlled trial.,"STUDY OBJECTIVE


Erector spinae plane (ESP) block is a novel regional anesthesia technique and gaining importance for postoperative pain management. Since it was first described, the clinicians wonder if this new simple technique can replace paravertebral block (PVB). We aimed to compare the postoperative analgesic effect of ESP block and PVB with a control group in breast surgeries.
DESIGN


Randomized controlled trial.
SETTING


Operating room.
PATIENTS


Seventy-five ASA I-II patients aged 25-65, who were scheduled to go under elective unilateral breast surgery for breast cancer were included to the study.
INTERVENTIONS


Patients were randomized into three groups as ESP, PVB, and Control group. Ultrasound (US) guided ESP block and PVB with 20 ml 0.25% bupivacaine was done preoperatively to the patients according to their groups.
MEASUREMENTS


All patients were provided with iv patient-controlled analgesia device for postoperative analgesia. Morphine consumptions and numeric rating scale (NRS) scores for pain were recorded at 1st, 6th, 12th and 24th hours postoperatively.
MAIN RESULTS


There was a statistically significant difference between ESP and Control groups (p < 0,001) and between PVB and Control groups (p < 0,001), while there was no difference between ESP and PVB groups (p > 0,05) for 24-hour morphine consumptions. There was a significant difference between PVB and Control groups for NRS at postoperative 1st and 6th hour (p = 0.018 and p = 0.027 respectively).
CONCLUSIONS


This study has shown that US guided ESP block and PVB provided adequate analgesia in patients undergoing breast surgery and have an opioid sparing effect by reducing morphine consumption. Clinical Trials Registry: NCT03480958.",2020,"There was a statistically significant difference between ESP and Control groups (p < 0,001) and between PVB and Control groups (p < 0,001), while there was no difference between ESP and PVB groups (p > 0,05) for 24-hour morphine consumptions.","['patients undergoing breast surgery', 'Seventy-five ASA I-II patients aged 25-65, who were scheduled to go under elective unilateral breast surgery for breast cancer were included to the study']","['IV-morphine', 'ESP block and PVB', 'Ultrasound (US) guided ESP block and PVB with 20\u202fml 0.25% bupivacaine', 'Erector spinae plane block and thoracic paravertebral block', 'ESP, PVB, and Control group']",['Morphine consumptions and numeric rating scale (NRS) scores for pain'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0851312', 'cui_str': 'Breast surgery'}, {'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0015373', 'cui_str': 'Extrasensory Perception'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",75.0,0.0553276,"There was a statistically significant difference between ESP and Control groups (p < 0,001) and between PVB and Control groups (p < 0,001), while there was no difference between ESP and PVB groups (p > 0,05) for 24-hour morphine consumptions.","[{'ForeName': 'Yavuz', 'Initials': 'Y', 'LastName': 'Gürkan', 'Affiliation': 'Department of Anesthesiology and Reanimation, Kocaeli University Hospital, 41380 Kocaeli, Turkey.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Aksu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Kocaeli University Hospital, 41380 Kocaeli, Turkey. Electronic address: dr.aksu@gmail.com.'}, {'ForeName': 'Alparslan', 'Initials': 'A', 'LastName': 'Kuş', 'Affiliation': 'Department of Anesthesiology and Reanimation, Kocaeli University Hospital, 41380 Kocaeli, Turkey.'}, {'ForeName': 'Ufuk H', 'Initials': 'UH', 'LastName': 'Yörükoğlu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Kocaeli University Hospital, 41380 Kocaeli, Turkey.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2019.06.036']
1141,31274710,FOVEA-SPARING VERSUS COMPLETE INTERNAL LIMITING MEMBRANE PEELING IN VITRECTOMY FOR THE TREATMENT OF MACULAR HOLES.,"PURPOSE


To compare the anatomical and functional outcomes of vitrectomy involving complete internal limiting membrane peeling (CP) with those of vitrectomy involving fovea-sparing internal limiting membrane peeling (FSP) for the treatment of macular holes measuring >250 µm.
METHODS


This prospective, randomized, comparative study included 46 eyes with a medium or large macular hole that was randomized to undergo complete (CP group) or fovea-sparing (FSP group) internal limiting membrane peeling during vitrectomy. The main outcome measures included the foveal retinal sensitivity, visual acuity, and central retinal thickness.
RESULTS


Both groups showed significantly improved foveal retinal sensitivity after surgery; the mean foveal retinal sensitivity change at 12 months after surgery was +2.8 ± 2.1 dB in the CP group and +7.2 ± 2.3 dB in the FSP group. The visual acuity also showed a significant improvement in both groups, with no significant differences in values at any time point. Regarding central retinal thickness, there was a significant decrease in the CP group and no change in the FSP group. Nicks or dimples in the inner retinal layers were visible in the fovea and perifovea of nine eyes in the CP group.
CONCLUSION


Our findings suggest that both CP and FSP are safe and effective treatments leading to functional and anatomical improvements in patients with all size macular holes. However, the fovea-sparing technique may provide better functional outcomes because of a greater improvement in foveal retinal sensitivity.",2020,"Nicks or dimples in the inner retinal layers were visible in the fovea and perifovea of nine eyes in the CP group.
","['patients with all size macular holes', '46 eyes with a medium or large macular hole that was randomized to']","['vitrectomy involving complete internal limiting membrane peeling (CP', 'undergo complete (CP group) or fovea-sparing (FSP group) internal limiting membrane peeling during vitrectomy', 'vitrectomy involving fovea-sparing internal limiting membrane peeling (FSP', 'CP and FSP']","['foveal retinal sensitivity', 'visual acuity', 'mean foveal retinal sensitivity change', 'central retinal thickness', 'foveal retinal sensitivity, visual acuity, and central retinal thickness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0024441', 'cui_str': 'Macular Holes'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]","[{'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]",46.0,0.0427441,"Nicks or dimples in the inner retinal layers were visible in the fovea and perifovea of nine eyes in the CP group.
","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Morescalchi', 'Affiliation': 'Department of Neurological and Vision Sciences, Eye Clinic, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Russo', 'Affiliation': 'Department of Neurological and Vision Sciences, Eye Clinic, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Bahja', 'Affiliation': 'Department of Neurological and Vision Sciences, Eye Clinic, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Gambicorti', 'Affiliation': 'Department of Neurological and Vision Sciences, Eye Clinic, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Cancarini', 'Affiliation': 'Department of Neurological and Vision Sciences, Eye Clinic, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Ciro', 'Initials': 'C', 'LastName': 'Costagliola', 'Affiliation': 'Department of Health Sciences, Eye Clinic, University of Molise, Campobasso, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Semeraro', 'Affiliation': 'Department of Neurological and Vision Sciences, Eye Clinic, University of Brescia, Brescia, Italy.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002612']
1142,31282447,Longitudinal study of hyperbaric oxygen intervention on balance and affective symptoms in military service members with persistent post-concussive symptoms.,"BACKGROUND


Dizziness and imbalance are common after mild traumatic brain injury (mTBI). Hyperbaric oxygen (HBO2) has been proposed for persistent post-concussive symptoms after mTBI, but its effect on vestibular function is unknown.
OBJECTIVE


To describe balance function in military service-members before and after intervention, and to explore the influence of post-traumatic stress disorder (PTSD), anxiety, and depression on vestibular outcomes.
METHODS


Seventy-one participants with mTBI and seventy-five healthy adults without brain injury were enrolled (NCT01611194 and NCT01925963). mTBI participants were randomized to 40 HBO2 sessions or 40 sham chamber sessions over 12 weeks. Normative controls received no intervention. Balance and neuropsychological function were measured at baseline, 13 weeks, and 6 months.
RESULTS


The mTBI cohort performed worse than healthy controls on balance and gait measures and reported more affective symptoms. Some within-group improvements were noted at 13 weeks and 6 months. Significant between-intervention differences on balance measures were minimal but effects on postural control generally favored HBO2. Those with affective symptoms, particularly PTSD, had the most improvement in postural control and otolith function following 13 weeks of HBO2.
CONCLUSION


HBO2 may influence balance function after mTBI, particularly in those with affective symptoms.",2019,"Those with affective symptoms, particularly PTSD, had the most improvement in postural control and otolith function following 13 weeks of HBO2.
","['Seventy-one participants with mild TBI and seventy-five healthy adults without brain injury', 'military service members with\xa0persistent post-concussive symptoms', 'Mild TBI participants']","['Hyperbaric oxygen (HBO2', 'HBO2', 'hyperbaric oxygen intervention']","['balance and affective symptoms', 'balance measures', 'postural control and otolith function', 'Balance and neuropsychological function', 'balance and gait measures']","[{'cui': 'C0450389', 'cui_str': '71 (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0270611', 'cui_str': 'Brain Injuries'}, {'cui': 'C0336524', 'cui_str': 'Military services member'}, {'cui': 'C0546983', 'cui_str': 'Post-Concussion Symptoms'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0001726', 'cui_str': 'Affective Symptoms'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0029894', 'cui_str': 'Otoconia'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0016928', 'cui_str': 'Gait'}]",71.0,0.0368017,"Those with affective symptoms, particularly PTSD, had the most improvement in postural control and otolith function following 13 weeks of HBO2.
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Meehan', 'Affiliation': 'Lovelace Biomedical Research, Albuquerque, New Mexico, USA.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Hebert', 'Affiliation': 'Emmes, Rockville, MD, USA.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'Deru', 'Affiliation': 'Division of Hyperbaric Medicine Intermountain Medical Center, Murray, UT, and Intermountain LDS Hospital, Salt Lake City, UT, USA.'}, {'ForeName': 'Lindell K', 'Initials': 'LK', 'LastName': 'Weaver', 'Affiliation': 'Division of Hyperbaric Medicine Intermountain Medical Center, Murray, UT, and Intermountain LDS Hospital, Salt Lake City, UT, USA.'}]",Journal of vestibular research : equilibrium & orientation,['10.3233/VES-180671']
1143,31217316,"Effects of vestibular rehabilitation, with or without betahistine, on managing residual dizziness after successful repositioning manoeuvres in patients with benign paroxysmal positional vertigo: a protocol for a randomised controlled trial.","INTRODUCTION


Benign paroxysmal positional vertigo (BPPV) is recognised as the leading cause of peripheral vertigo in adults. The canalith repositioning procedure (CRP) can be used for effective treatment of BPPV. However, some patients experience residual dizziness (RD) even after successful CRP, resulting in a significant negative impact on their daily function and quality of life. Exercise-based vestibular rehabilitation (VR) has been proven as an effective method for managing dizziness and has been applied in patients with various vestibular disorders. However, the efficacy of VR to specifically target RD post-BPPV is unknown. This study aims to investigate the efficacy of VR, compared with betahistine or VR plus betahistine treatment, in the treatment of patients experiencing RD after successful CRP.
METHODS AND ANALYSIS


A randomised single-blinded controlled trial will be carried out to determine the efficacy of VR compared with betahistine or VR plus betahistine treatment in mitigating RD and improving balance function. Patients with BPPV who experience RD after successful CRP will be recruited. Participants will be randomised into one of three groups to receive VR, betahistine or VR plus betahistine. There will be 61 participants in each group. The primary outcomes will be changes in the patient's daily function as measured by the Vestibular Activities and Participation questionnaire and balance ability assessed by computerised dynamic posturography. The secondary outcomes will be dizziness-related handicap, otolith function and duration of RD symptoms. Outcome measures will be noted at baseline and at 2, 4 and 8 weeks post-randomisation. This study has the potential to reduce unnecessary anti-vertigo drug prescriptions and may lead to a general consensus regarding the use of VR as a first-line treatment for RD in patients with BPPV.
ETHICS AND DISSEMINATION


This trial received ethical approval from the Institutional Review Board of Eye and ENT Hospital of Fudan University (reference number 2017046). The study results will be disseminated via peer-reviewed journals and conferences.
TRIAL REGISTRATION NUMBER


NCT03624283; Pre-results.",2019,A randomised single-blinded controlled trial will be carried out to determine the efficacy of VR compared with betahistine or VR plus betahistine treatment in mitigating RD and improving balance function.,"['patients with benign paroxysmal positional vertigo', 'Patients with BPPV who experience RD after successful CRP', '61 participants in each group', 'patients experiencing RD after successful CRP', 'patients with BPPV', 'patients with various vestibular disorders']","['betahistine or VR plus betahistine', 'VR, betahistine or VR plus betahistine', 'canalith repositioning procedure (CRP', 'vestibular rehabilitation, with or without betahistine', 'Exercise-based vestibular rehabilitation (VR']","['residual dizziness (RD', 'dizziness-related handicap, otolith function and duration of RD symptoms', 'daily function and quality of life', 'balance function', ""changes in the patient's daily function as measured by the Vestibular Activities and Participation questionnaire and balance ability assessed by computerised dynamic posturography""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0155502', 'cui_str': 'Vertigo, Benign Recurrent'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2609434', 'cui_str': 'Vestibular disorders (SMQ)'}]","[{'cui': 'C0005301', 'cui_str': 'BETAHISTINE'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0556030', 'cui_str': 'Repositioning (procedure)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0029894', 'cui_str': 'Otoconia'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance (observable entity)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0919611', 'cui_str': 'Posturography'}]",,0.0700054,A randomised single-blinded controlled trial will be carried out to determine the efficacy of VR compared with betahistine or VR plus betahistine treatment in mitigating RD and improving balance function.,"[{'ForeName': 'Peixia', 'Initials': 'P', 'LastName': 'Wu', 'Affiliation': 'Department of Nursing, Eye and ENT Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Wenzhu', 'Initials': 'W', 'LastName': 'Cao', 'Affiliation': 'Department of Intensive Care Unit, Eye and ENT Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'School of Nursing, Fudan University, Shanghai, China.'}, {'ForeName': 'Huawei', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Otorhinolaryngolohy, Eye and ENT Hospital of Fudan University, Shanghai, China.'}]",BMJ open,['10.1136/bmjopen-2018-026711']
1144,31286850,"""I Had Not Seen Star Wars"" and Other Motives for Divorce in Denmark.","A total of 2,371 Danish residents participating in the Cooperation After Divorce randomized controlled trial study indicated the motives for their divorce. The most frequently given motives were lack of love/intimacy, communication problems, lack of sympathy/respect/trust, and growing apart. The least reported motives were violence, addiction, accident or illness, and personality. The results support global trends regarding an increased importance of emotional and psychological aspects of relationships. A factor analysis seeking to identify clusters in the motives did not yield statistically or theoretically strong results. This may indicate that experiences with and motives for divorce are heterogeneous and multifactorial.",2020,A factor analysis seeking to identify clusters in the motives did not yield statistically or theoretically strong results.,"['2,371 Danish residents participating in the Cooperation']",[],"['violence, addiction, accident or illness, and personality']",[],[],"[{'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C1961149', 'cui_str': 'Accidental physical contact (event)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0031208', 'cui_str': 'Personality'}]",,0.0364831,A factor analysis seeking to identify clusters in the motives did not yield statistically or theoretically strong results.,"[{'ForeName': 'Jenna Marie', 'Initials': 'JM', 'LastName': 'Strizzi', 'Affiliation': 'Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Sander', 'Affiliation': 'Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ciprić', 'Affiliation': 'Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Gert Martin', 'Initials': 'GM', 'LastName': 'Hald', 'Affiliation': 'Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}]",Journal of sex & marital therapy,['10.1080/0092623X.2019.1641871']
1145,31286397,The Effect of Intraoperative Dexmedetomidine Versus Morphine on Postoperative Morphine Requirements After Laparoscopic Bariatric Surgery.,"BACKGROUND


Dexmedetomidine is an α 2  receptor agonist with sedative and analgesic properties. During bariatric surgery, its use may reduce postoperative opioid requirements, reduce their side effects, and improve quality of recovery. The aim of this prospective randomized controlled trial was to compare the effect of dexmedetomidine bolus and infusion versus morphine bolus given prior to the end of laparoscopic bariatric surgery.
METHODS


Sixty morbidly obese patients (BMI > 40 kg m -2 ) aged 18 to 60 years, undergoing laparoscopic sleeve gastrectomy, received morphine sulfate (bolus 0.08 mg kg -1  followed by a saline infusion) (group M, n = 30) or dexmedetomidine (loading dose of 1 μg kg -1  followed by 0.5 μg kg -1  h -1 ) (group D, n = 30) 30 min before the end of surgery. Data collected included morphine consumption in the post-anesthesia care unit (PACU) (primary outcome) and at 24 h, pain intensity, nausea, heart rate, blood pressure, vomiting, sedation, and quality of recovery.
RESULTS


There was no significant difference in morphine consumption in the PACU (group D 12.2 ± 5.44 mg, group M 13.28 ± 6.64 mg, P = 0.54) or at 24 h (group D 40.67 ± 24.78 mg, group M 43.28 ± 27.79 mg, P = 0.75); when accounting for intraoperative morphine given group M had significantly higher morphine consumption when compared to group D (23.48 ± 6.22 mg vs. 12.22 ± 5.54 mg, respectively, P < 0.01). Group D patients had more cardiovascular stability.
CONCLUSIONS


Dexmedetomidine given prior to end of laparoscopic sleeve gastrectomy provides the same level of postoperative analgesia as morphine with better hemodynamic profile.",2019,"There was no significant difference in morphine consumption in the PACU (group D 12.2 ± 5.44 mg, group M 13.28 ± 6.64 mg, P = 0.54) or at 24 h (group D 40.67 ± 24.78 mg, group M 43.28 ± 27.79 mg, P = 0.75); when accounting for intraoperative morphine given group M had significantly higher morphine consumption when compared to group D (23.48 ± 6.22 mg vs. 12.22 ± 5.54 mg, respectively, P < 0.01).","['aged 18 to 60\xa0years, undergoing', 'Sixty morbidly obese patients (BMI\u2009>\u200940\xa0kg']","['Laparoscopic Bariatric Surgery', 'Dexmedetomidine', 'morphine sulfate (bolus 0.08', 'dexmedetomidine (loading dose of 1\xa0μg\xa0kg -1  followed by 0.5\xa0μg', 'PACU', 'laparoscopic sleeve gastrectomy', 'Intraoperative Dexmedetomidine Versus Morphine', 'dexmedetomidine bolus and infusion versus morphine']","['Postoperative Morphine Requirements', 'morphine consumption', '24\xa0h, pain intensity, nausea, heart rate, blood pressure, vomiting, sedation, and quality of recovery', 'cardiovascular stability']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0066814', 'cui_str': 'Morphine Sulfate'}, {'cui': 'C4517417', 'cui_str': 'Zero point zero eight'}, {'cui': 'C3714444', 'cui_str': 'Loading dose'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",60.0,0.402263,"There was no significant difference in morphine consumption in the PACU (group D 12.2 ± 5.44 mg, group M 13.28 ± 6.64 mg, P = 0.54) or at 24 h (group D 40.67 ± 24.78 mg, group M 43.28 ± 27.79 mg, P = 0.75); when accounting for intraoperative morphine given group M had significantly higher morphine consumption when compared to group D (23.48 ± 6.22 mg vs. 12.22 ± 5.54 mg, respectively, P < 0.01).","[{'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Zeeni', 'Affiliation': 'Department of Anesthesiology, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Marie T', 'Initials': 'MT', 'LastName': 'Aouad', 'Affiliation': 'Department of Anesthesiology, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Dayane', 'Initials': 'D', 'LastName': 'Daou', 'Affiliation': 'Keserwan Medical Center, Keserwan, Jounieh, Lebanon.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Naji', 'Affiliation': 'Department of Anesthesiology, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Samar', 'Initials': 'S', 'LastName': 'Jabbour-Khoury', 'Affiliation': 'Department of Anesthesiology, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Ramzi S', 'Initials': 'RS', 'LastName': 'Alami', 'Affiliation': 'Department of Surgery, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Bassem Y', 'Initials': 'BY', 'LastName': 'Safadi', 'Affiliation': 'Department of Surgery, Lebanese American University, Beirut, Lebanon.'}, {'ForeName': 'Sahar M', 'Initials': 'SM', 'LastName': 'Siddik-Sayyid', 'Affiliation': 'Department of Anesthesiology, American University of Beirut Medical Center, Beirut, Lebanon. ss01@aub.edu.lb.'}]",Obesity surgery,['10.1007/s11695-019-04074-1']
1146,31838009,"Role of eHealth application Oncokompas in supporting self-management of symptoms and health-related quality of life in cancer survivors: a randomised, controlled trial.","BACKGROUND


Knowledge about the efficacy of behavioural intervention technologies that can be used by cancer survivors independently from a health-care provider is scarce. We aimed to assess the efficacy, reach, and usage of Oncokompas, a web-based eHealth application that supports survivors in self-management by monitoring health-related quality of life (HRQOL) and cancer-generic and tumour-specific symptoms and obtaining tailored feedback with a personalised overview of supportive care options.
METHODS


In this non-blinded, randomised, controlled trial, we recruited patients treated at 14 hospitals in the Netherlands for head and neck cancer, colorectal cancer, breast cancer, Hodgkin lymphoma, or non-Hodgkin lymphoma. Adult survivors (aged ≥18 years) were recruited through the Netherlands Cancer Registry (NCR) and invited by their treating physician through the Patient Reported Outcomes Following Initial Treatment and Long term Evaluation of Survivorship (PROFILES) registry. Participants were randomly assigned (1:1) by an independent researcher to the intervention group (access to Oncokompas) or control group (access to Oncokompas after 6 months), by use of block randomisation (block length of 68), stratified by tumour type. The primary outcome was patient activation (knowledge, skills, and confidence for self-management), assessed at baseline, post-intervention, and 3-month and 6-month follow-up. Linear mixed models (intention-to-treat) were used to assess group differences over time from baseline to 6-month follow-up. The trial is registered in the Netherlands Trial Register, NTR5774 and is completed.
FINDINGS


Between Oct 12, 2016, and May 24, 2018, 625 (21%) of 2953 survivors assessed for eligibility were recruited and randomly assigned to the intervention (320) or control group (305). Median follow-up was 6 months (IQR 6-6). Patient activation was not significantly different between intervention and control group over time (difference at 6-month follow-up 1·7 [95% CI -0·8-4·1], p=0·41).
INTERPRETATION


Oncokompas did not improve the amount of knowledge, skills, and confidence for self-management in cancer survivors. This study contributes to the evidence for the development of tailored strategies for development and implementation of behavioural intervention technologies among cancer survivors.
FUNDING


Dutch Cancer Society (KWF Kankerbestrijding).",2020,Patient activation was not significantly different between intervention and control group over time (difference at 6-month follow-up 1·7,"['Between Oct 12, 2016, and May 24, 2018, 625 (21%) of 2953 survivors assessed for eligibility', 'Adult survivors (aged ≥18 years) were recruited through the Netherlands Cancer Registry (NCR) and invited by their treating physician through the Patient', 'cancer survivors', 'recruited patients treated at 14 hospitals in the Netherlands for head and neck cancer, colorectal cancer, breast cancer, Hodgkin lymphoma, or non-Hodgkin lymphoma']","['eHealth application Oncokompas', 'intervention group (access to Oncokompas) or control group (access to Oncokompas']","['patient activation (knowledge, skills, and confidence for self-management', 'Patient activation']","[{'cui': 'C4517838', 'cui_str': 'Six hundred and twenty-five'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0332273', 'cui_str': 'Through (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1266193', 'cui_str': 'Hodgkin lymphoma - category (morphologic abnormality)'}, {'cui': 'C0024305', 'cui_str': ""Lymphoma, Nonhodgkin's""}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}]",2953.0,0.21781,Patient activation was not significantly different between intervention and control group over time (difference at 6-month follow-up 1·7,"[{'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'van der Hout', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Cornelia F', 'Initials': 'CF', 'LastName': 'van Uden-Kraan', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Holtmaat', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Femke', 'Initials': 'F', 'LastName': 'Jansen', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; Department of Otolaryngology-Head and Neck Surgery, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Birgit I', 'Initials': 'BI', 'LastName': 'Lissenberg-Witte', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Grard A P', 'Initials': 'GAP', 'LastName': 'Nieuwenhuijzen', 'Affiliation': 'Department of Surgery, Catharina Hospital, Eindhoven, Netherlands.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Hardillo', 'Affiliation': 'Department of Otolaryngology and Head and Neck Surgery, Rotterdam, Netherlands.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Baatenburg de Jong', 'Affiliation': 'Department of Otolaryngology and Head and Neck Surgery, Rotterdam, Netherlands.'}, {'ForeName': 'Nicolette L', 'Initials': 'NL', 'LastName': 'Tiren-Verbeet', 'Affiliation': 'Department of Haematology, Erasmus Medical Centre, Rotterdam, Netherlands.'}, {'ForeName': 'Dirkje W', 'Initials': 'DW', 'LastName': 'Sommeijer', 'Affiliation': 'Department of Internal Medicine, Flevoziekenhuis, Almere, Netherlands; Department of Medical Oncology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'de Heer', 'Affiliation': 'Department of Internal Medicine, Flevoziekenhuis, Almere, Netherlands; Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Cees G', 'Initials': 'CG', 'LastName': 'Schaar', 'Affiliation': 'Department of Internal Medicine, Gelre ziekenhuis, Apeldoorn, Netherlands.'}, {'ForeName': 'Robert-Jan E', 'Initials': 'RE', 'LastName': 'Sedee', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Haaglanden MC, The Hague, Netherlands.'}, {'ForeName': 'Koop', 'Initials': 'K', 'LastName': 'Bosscha', 'Affiliation': 'Department of Surgery, Jeroen Bosch Ziekenhuis, Den Bosch, Netherlands.'}, {'ForeName': 'Michiel W M', 'Initials': 'MWM', 'LastName': 'van den Brekel', 'Affiliation': 'Department of Head and Neck Oncology and Surgery, Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Japke F', 'Initials': 'JF', 'LastName': 'Petersen', 'Affiliation': 'Department of Head and Neck Oncology and Surgery, Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Westerman', 'Affiliation': 'Department of Hematology, Northwest Clinics, Alkmaar, Netherlands.'}, {'ForeName': 'Jimmie', 'Initials': 'J', 'LastName': 'Honings', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Takes', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Houtenbos', 'Affiliation': 'Department of Hematology, Spaarne Gasthuis, Hoofddorp, Netherlands.'}, {'ForeName': 'Wim T', 'Initials': 'WT', 'LastName': 'van den Broek', 'Affiliation': 'Department of Surgery, St Anna Hospital, Geldrop, Netherlands.'}, {'ForeName': 'Remco', 'Initials': 'R', 'LastName': 'de Bree', 'Affiliation': 'Department of Head and Neck Surgical Oncology, Utrecht University Medical Center, Utrecht, Netherlands.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Jansen', 'Affiliation': 'Department of Surgery, Elisabeth-TweeSteden Hospital, Tilburg, Netherlands.'}, {'ForeName': 'Simone E J', 'Initials': 'SEJ', 'LastName': 'Eerenstein', 'Affiliation': 'Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; Department of Otolaryngology-Head and Neck Surgery, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'C René', 'Initials': 'CR', 'LastName': 'Leemans', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Josée M', 'Initials': 'JM', 'LastName': 'Zijlstra', 'Affiliation': 'Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; Department of Hematology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Cuijpers', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Lonneke V', 'Initials': 'LV', 'LastName': 'van de Poll-Franse', 'Affiliation': 'Department of Research, Netherlands Comprehensive Cancer Organisation, Eindhoven, Netherlands; Division of Psychosocial Research and Epidemiology, Netherlands Cancer Institute, Netherlands; Center of Research on Psychological and Somatic Disorders, Department of Medical and Clinical Psychology, Tilburg University, Tilburg, Netherlands.'}, {'ForeName': 'Irma M', 'Initials': 'IM', 'LastName': 'Verdonck-de Leeuw', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; Department of Otolaryngology-Head and Neck Surgery, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands. Electronic address: im.verdonck@amsterdamumc.nl.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30675-8']
1147,31838010,"Ribociclib plus letrozole versus chemotherapy for postmenopausal women with hormone receptor-positive, HER2-negative, luminal B breast cancer (CORALLEEN): an open-label, multicentre, randomised, phase 2 trial.","BACKGROUND


In hormone receptor-positive, HER2-negative early stage breast cancer, cyclin-dependent kinases 4 and 6 (CDK4/6) inhibition in combination with endocrine therapy could represent an alternative to multiagent chemotherapy. We aimed to evaluate the biological and clinical activity of neoadjuvant ribociclib plus letrozole in the luminal B subtype of early stage breast cancer.
METHODS


CORALLEEN is a parallel-arm, multicentre, randomised, open-label, phase 2 trial completed across 21 hospitals in Spain. We recruited postmenopausal women (≥18 years) with stage I-IIIA hormone receptor-positive, Eastern Cooperative Oncology Group Performance Status 0-1, HER2-negative breast cancer and luminal B by PAM50 with histologically confirmed, operable primary tumour size of at least 2 cm in diameter as measured by MRI. Patients were randomly assigned (1:1) using a web-based system and permuted blocks of 25 to receive either six 28-days cycles of ribociclib (oral 600 mg once daily for 3 weeks on, 1 week off) plus daily letrozole (oral 2·5 mg/day) or four cycles of doxorubicin (intravenous 60 mg/m 2 ) and cyclophosphamide (intravenous 600 mg/m 2 ) every 21 days followed by weekly paclitaxel (intravenous 80 mg/m 2 ) for 12 weeks. The total duration of the neoadjuvant therapy was 24 weeks. Randomisation was stratified by tumour size and nodal involvement. Samples were prospectively collected at baseline (day 0), day 15, and surgery. The primary endpoint was to evaluate the proportion of patients with PAM50 low-risk-of-relapse (ROR) disease at surgery in the modified intention-to-treat population including all randomly assigned patients who received study drug and had a baseline and at least one post-baseline measurement of ROR score. The PAM50 ROR risk class integrated gene expression data, tumour size, and nodal status to define prognosis. This trial was registered at ClinicalTrials.gov, NCT03248427.
FINDINGS


Between July 27, 2017 to Dec 7, 2018, 106 patients were enrolled. At baseline, of the 106 patients, 92 (87%) patients had high ROR disease (44 [85%] of 52 in the ribociclib and letrozole group and 48 [89%] of 54 in the chemotherapy group) and 14 (13%) patients had intermediate-ROR disease (eight [15%] and six [11%]). Median follow-up was 200·0 days (IQR 191·2-206·0). At surgery, 23 (46·9%; 95% CI 32·5-61·7) of 49 patients in the ribociclib plus letrozole group and 24 (46·1%; 32·9-61·5) of 52 patients in the chemotherapy group were low-ROR. The most common grade 3-4 adverse events in the ribociclib plus letrozole group were neutropenia (22 [43%] of 51 patients) and elevated alanine aminotransferase concentrations (ten [20%]). The most common grade 3-4 adverse events in the chemotherapy group were neutropenia (31 [60%] of 52 patients) and febrile neutropenia (seven [13%]). No deaths were observed during the study in either group.
INTERPRETATION


Our results suggest that some patients with high-risk, early stage, hormone receptor-positive, HER2-negative breast cancer could achieve molecular downstaging of their disease with CDK4/6 inhibitor and endocrine therapy.
FUNDING


Novartis, Nanostring, Breast Cancer Research Foundation-AACR Career Development Award.",2020,"At surgery, 23 (46·9%; 95% CI 32·5-61·7) of 49 patients in the ribociclib plus letrozole group and 24 (46·1%; 32·9-61·5) of 52 patients in the chemotherapy group were low-ROR.","['recruited postmenopausal women (≥18 years) with stage', '21 hospitals in Spain', 'Between July 27, 2017 to Dec 7, 2018, 106 patients were enrolled', 'postmenopausal women with hormone receptor-positive, HER2-negative, luminal B breast cancer (CORALLEEN']","['ribociclib (oral 600 mg once daily for 3 weeks on, 1 week off) plus daily letrozole (oral 2·5 mg/day) or four cycles of doxorubicin (intravenous 60 mg/m 2 ) and cyclophosphamide (intravenous 600 mg/m 2 ) every 21 days followed by weekly paclitaxel', 'Ribociclib plus letrozole', 'neoadjuvant ribociclib plus letrozole', 'endocrine therapy', 'ribociclib plus letrozole', 'letrozole', 'chemotherapy']","['elevated alanine aminotransferase concentrations', 'proportion of patients with PAM50 low-risk-of-relapse (ROR) disease', 'high ROR disease', 'low-ROR', 'total duration', 'neutropenia', 'febrile neutropenia', 'deaths', 'intermediate-ROR disease', 'ROR score']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C4045494', 'cui_str': 'ribociclib'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C3873150', 'cui_str': 'Every twenty one days (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",106.0,0.215267,"At surgery, 23 (46·9%; 95% CI 32·5-61·7) of 49 patients in the ribociclib plus letrozole group and 24 (46·1%; 32·9-61·5) of 52 patients in the chemotherapy group were low-ROR.","[{'ForeName': 'Aleix', 'Initials': 'A', 'LastName': 'Prat', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain; Department of Medical Oncology, Hospital Clinic of Barcelona, Barcelona, Spain; Translational Genomics and Targeted Therapeutics in Solid Tumors, August Pi i Sunyer Biomedical Research Institute, Barcelona, Spain. Electronic address: alprat@clinic.cat.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Saura', 'Affiliation': ""SOLTI Breast Cancer Research Group, Barcelona, Spain; Department of Medical Oncology, Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Pascual', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain; Department of Medical Oncology, Hospital Clinic of Barcelona, Barcelona, Spain; Translational Genomics and Targeted Therapeutics in Solid Tumors, August Pi i Sunyer Biomedical Research Institute, Barcelona, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Hernando', 'Affiliation': 'Department of Medical Oncology, Hospital Clínico Universitario of Valencia, Valencia, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Muñoz', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain; Department of Medical Oncology, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Paré', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain.'}, {'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'González Farré', 'Affiliation': 'Department of Pathology, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Pedro L', 'Initials': 'PL', 'LastName': 'Fernández', 'Affiliation': 'Department of Pathology, Hospital Germans Trials i Pujol, Badalona, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Galván', 'Affiliation': 'Translational Genomics and Targeted Therapeutics in Solid Tumors, August Pi i Sunyer Biomedical Research Institute, Barcelona, Spain.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Chic', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain; Translational Genomics and Targeted Therapeutics in Solid Tumors, August Pi i Sunyer Biomedical Research Institute, Barcelona, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'González Farré', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain; Department of Medical Oncology, Hospital General de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Mafalda', 'Initials': 'M', 'LastName': 'Oliveira', 'Affiliation': ""SOLTI Breast Cancer Research Group, Barcelona, Spain; Department of Medical Oncology, Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Gil-Gil', 'Affiliation': ""Department of Medical Oncology, Institut Català d'Oncologia Hospitalet, Hospitalet de Llobregat, Spain.""}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Arumi', 'Affiliation': ""Department of Medical Oncology, Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Neus', 'Initials': 'N', 'LastName': 'Ferrer', 'Affiliation': 'Department of Medical Oncology, Hospital Universitari Son Espases, Palma de Mallorca, Spain.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Montaño', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Sevilla, Spain.'}, {'ForeName': 'Yann', 'Initials': 'Y', 'LastName': 'Izarzugaza', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario Fundación Jimenez Díaz, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Llombart-Cussac', 'Affiliation': 'Department of Medical Oncology, Hospital Arnau de Vilanova, Valencia, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Bratos', 'Affiliation': 'Department of Medical Oncology, Centro Oncológico Internacional MD Anderson, Madrid, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'González Santiago', 'Affiliation': 'Department of Medical Oncology, Hospital San Pedro de Alcántara, Cáceres, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Martínez', 'Affiliation': 'Department of Medical Oncology, Consorcio Hospitalario Provincial of Castellón, Castellón de la Plana, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Hoyos', 'Affiliation': 'Department of Medical Oncology, Hospital Rey Juan Carlos, Madrid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Rojas', 'Affiliation': 'Department of Medical Oncology, Centro Integral Oncológico Clara Campal, Madrid, Spain.'}, {'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'Virizuela', 'Affiliation': 'Department of Medical Oncology, Hospital Virgen de la Macarena, Sevilla, Spain.'}, {'ForeName': 'Vanesa', 'Initials': 'V', 'LastName': 'Ortega', 'Affiliation': 'Department of Medical Oncology, Fundación Privada Asil de Granollers, Barcelona, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'López', 'Affiliation': 'Department of Medical Oncology, Complejo Universitario de Santiago de Compostela, Spain.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Céliz', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Ciruelos', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain; Department of Medical Oncology, Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Villagrasa', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Gavilá', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain; Department of Medical Oncology, Instituto Valenciano de Oncología, Valencia, Spain.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30786-7']
1148,31230964,High-Flow Therapy by Nasal Cannulae Versus High-Flow Face Mask in Severe Hypoxemia After Cardiac Surgery: A Single-Center Randomized Controlled Study-The HEART FLOW Study.,"OBJECTIVE


To determine whether high-flow oxygen therapy by nasal cannulae (HFNC) is more effective than a high-flow face mask (HFFM) in severe hypoxemia.
DESIGN


Randomized, single-center, open-labeled, controlled trial.
SETTING


University Hospital of Nantes, France.
PARTICIPANTS


Cardiac surgery patients presenting oxygen saturation <96% with Venturi mask 50%.
INTERVENTION


Oxygenation by HFNC (45 L/min, F I O 2  100%) or Hudson RCI non-rebreather face mask with a reservoir bag (15 L/min).
MEASUREMENTS AND MAIN RESULTS


The co-primary outcomes were the PaO 2 /F I O 2  ratio at 1 and 24 hours. In the intent-to-treat analysis (90 patients), the mean (standard deviation) PaO 2 /F I O 2  ratios were: after 1 hour, 113.4 (50.2) in HFFM versus 137.8 (57.0) in HFNC (mean difference 24.4, CI 97.5% [2.9-45.9], p = 0.03), and after 24 hours, 106.9 (62.6) in HFFM versus 129.9 (54.0) in HFNC (mean difference 23.0, CI 97.5% [1.5-44.6], p = 0.04). After adjustment on baseline PaO 2 /F I O 2,  this difference persisted at 24 hours (p = 0.04). For secondary outcomes, the PaO 2 /F I O 2  ratio after 6 hours was 108.7 (47.9) in HFFM versus 136.0 (45.2) in HFNC (p = 0.01), without difference after 48 hours (p = 0.95). Refractory hypoxemia requiring noninvasive ventilation occurred in 13 (28%) patients in HFNC versus 24 (56%) patients in HFFM (p = 0.007). The HFNC improved satisfaction (p = 0.0002) and reduced mucus dryness (p = 0.003) compared with HFFM.
CONCLUSION


In patients with severe hypoxemia after cardiac surgery, PaO 2 /F I O 2  at 1 and 24 hours were higher and the use of noninvasive ventilation was reduced in HFNC compared with HFFM.",2020,O 2  at 1 and 24 hours were higher and the use of noninvasive ventilation was reduced in HFNC compared with HFFM.,"['Cardiac surgery patients presenting oxygen saturation <96% with Venturi mask 50', 'University Hospital of Nantes, France', 'Severe Hypoxemia', 'patients with severe hypoxemia after cardiac surgery, PaO 2']","['F', 'High-Flow Therapy by Nasal Cannulae Versus High-Flow Face Mask', 'high-flow oxygen therapy by nasal cannulae (HFNC', 'Oxygenation by HFNC']","['reduced mucus dryness', 'noninvasive ventilation', 'HFNC improved satisfaction', 'Refractory hypoxemia requiring noninvasive ventilation']","[{'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C1998195', 'cui_str': 'Venturi mask'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0180823', 'cui_str': 'Face mask (physical object)'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0026727', 'cui_str': 'Mucus'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}]",,0.208062,O 2  at 1 and 24 hours were higher and the use of noninvasive ventilation was reduced in HFNC compared with HFFM.,"[{'ForeName': 'Mickael', 'Initials': 'M', 'LastName': ""Vourc'h"", 'Affiliation': 'Intensive Care Unit of Cardiothoracic Surgery, Department of Anesthesia and Critical Care, Hôpital Laennec, University Hospital of Nantes, Nantes, France. Electronic address: mickael.vourch@chu-nantes.fr.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Nicolet', 'Affiliation': 'Intensive Care Unit of Cardiothoracic Surgery, Department of Anesthesia and Critical Care, Hôpital Laennec, University Hospital of Nantes, Nantes, France.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Volteau', 'Affiliation': 'Department of Methodology and Biostatistics, Department of Research Promotion, University Hospital of Nantes, Nantes, France.'}, {'ForeName': 'Laurene', 'Initials': 'L', 'LastName': 'Caubert', 'Affiliation': 'Intensive Care Unit of Cardiothoracic Surgery, Department of Anesthesia and Critical Care, Hôpital Laennec, University Hospital of Nantes, Nantes, France.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Chabbert', 'Affiliation': 'Intensive Care Unit of Cardiothoracic Surgery, Department of Anesthesia and Critical Care, Hôpital Laennec, University Hospital of Nantes, Nantes, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lepoivre', 'Affiliation': 'Intensive Care Unit of Cardiothoracic Surgery, Department of Anesthesia and Critical Care, Hôpital Laennec, University Hospital of Nantes, Nantes, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Senage', 'Affiliation': 'Cardiovascular and Thoracic Surgery Unit, Hôpital Laënnec, University Hospital of Nantes, Nantes, France.'}, {'ForeName': 'Jean-Christian', 'Initials': 'JC', 'LastName': 'Roussel', 'Affiliation': 'Cardiovascular and Thoracic Surgery Unit, Hôpital Laënnec, University Hospital of Nantes, Nantes, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Rozec', 'Affiliation': 'Intensive Care Unit of Cardiothoracic Surgery, Department of Anesthesia and Critical Care, Hôpital Laennec, University Hospital of Nantes, Nantes, France.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2019.05.039']
1149,31275519,"Efficacy of chlorhexidine, hydrogen peroxide and tulsi extract mouthwash in reducing halitosis using spectrophotometric analysis: A randomized controlled trial.","Background


To evaluate the efficacy of tulsi extract mouthrinse in reducing halitosis as compared to chlorhexidine and hydrogen peroxide mouthrinses using spectrophotometric analysis.
Material and Methods


It was a parallel, single center, double blinded randomized controlled trial of 15 days duration. A total of 300 participants were screened, out of which 45 subjects those fulfilled inclusion criteria of age range 17-35 years were included in the trial. The participants were randomly provided with tulsi, hydrogen peroxide or chlorhexidine mouthwashes (control group) to use 10 ml twice daily for 15 days. Clinical measurements were taken at baseline and 15 days using arbitrary 0-5 scale for organoleptic odor assessments, spectrophotometric analysis for Volatile Sulphide Compounds (VSCs) from saliva samples, Löe & Silness gingival index and Silness & Löe plaque index.
Results


After intervention, organoleptic, VSCs, gingival and plaque scores showed statistically significant decrease in all the three study groups. The mean percentage reduction in VSC and organoleptic scores was significantly greater in chlorhexidine and hydrogen peroxide groups than in the tulsi group and the mean percentage reduction in plaque and gingival scores was significantly greater in chlorhexidine group than in hydrogen peroxide and tulsi group.
Conclusions


Tulsi may not have the efficacy of chlorhexidine and hydrogen peroxide mouthrinses. But, Tulsi is effective in reducing halitosis, plaque and gingivitis and with its lack of side effects & cost effectiveness, can be an effective & economic tool to deal with halitosis. The spectrophotometric technique appears to be a promising method for evaluation of oral malodor.  Key words: Halitosis, tulsi mouthwash, chlorhexidine, hydrogen peroxide, spectrophotometric analysis.",2019,"The mean percentage reduction in VSC and organoleptic scores was significantly greater in chlorhexidine and hydrogen peroxide groups than in the tulsi group and the mean percentage reduction in plaque and gingival scores was significantly greater in chlorhexidine group than in hydrogen peroxide and tulsi group.
","['300 participants were screened, out of which 45 subjects those fulfilled inclusion criteria of age range 17-35 years were included in the trial']","['chlorhexidine and hydrogen peroxide', 'hydrogen peroxide', 'tulsi, hydrogen peroxide or chlorhexidine mouthwashes (control group) to use 10 ml twice daily for 15 days', 'chlorhexidine, hydrogen peroxide and tulsi extract mouthwash', 'chlorhexidine', 'chlorhexidine, hydrogen peroxide, spectrophotometric analysis', 'tulsi extract mouthrinse']","['plaque and gingival scores', 'organoleptic, VSCs, gingival and plaque scores', 'VSC and organoleptic scores']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C3666901', 'cui_str': 'Chlorhexidine Mouthwash [Paroex]'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0026647', 'cui_str': 'Oral Rinse'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C4521854', 'cui_str': 'Gingival (intended site)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}]",300.0,0.0772057,"The mean percentage reduction in VSC and organoleptic scores was significantly greater in chlorhexidine and hydrogen peroxide groups than in the tulsi group and the mean percentage reduction in plaque and gingival scores was significantly greater in chlorhexidine group than in hydrogen peroxide and tulsi group.
","[{'ForeName': 'Kriti', 'Initials': 'K', 'LastName': 'Sharma', 'Affiliation': 'Dept. of Public Health Dentistry, Manipal College of Dental Sciences, Manipal Academy of Higher education, Madhav Nagar, Manipal, Karnataka.'}, {'ForeName': 'Shashidhar', 'Initials': 'S', 'LastName': 'Acharya', 'Affiliation': 'Dept. of Public Health Dentistry, Manipal College of Dental Sciences, Manipal Academy of Higher education, Madhav Nagar, Manipal, Karnataka.'}, {'ForeName': 'Eshan', 'Initials': 'E', 'LastName': 'Verma', 'Affiliation': 'Dept. of Public Health Dentistry, Manipal College of Dental Sciences, Manipal Academy of Higher education, Madhav Nagar, Manipal, Karnataka.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Singhal', 'Affiliation': 'Dept. of Public Health Dentistry, Manipal College of Dental Sciences, Manipal Academy of Higher education, Madhav Nagar, Manipal, Karnataka.'}, {'ForeName': 'Nishu', 'Initials': 'N', 'LastName': 'Singla', 'Affiliation': 'Dept. of Public Health Dentistry, Manipal College of Dental Sciences, Manipal Academy of Higher education, Madhav Nagar, Manipal, Karnataka.'}]",Journal of clinical and experimental dentistry,['10.4317/jced.55523']
1150,31280941,Comparison between new modified external rotation method and external rotation method for reduction of ASD.,"INTRODUCTION


Dislocation of the shoulder joint is common and is mainly anterior. Several reduction methods have been described and the external reduction method (ERM) is one of the newest. We modified the ERM by making some additions in hopes to develop a less painful, quick and simple method. The aim of this study was to compare the new modified external rotation reduction method (MERM) with ERM in acute anterior shoulder dislocations (ASD).
METHODS


A total of 62 patients with ASD were classified randomly into 2 groups. The reduction was performed with MERM in one group and with ERM in the other group and the results were compared. Patients' pain scores, reduction time, success rate of the reduction methods, age, sex, dislocation side, dislocation time, previous dislocations history, injury mechanism, any complications, reduction time and neurovascular examination were collected. Parametric and nonparametric analyses were used to compare MERM and ERM.
RESULTS


The study cohort consisted of 62 patients (52 males, 10 females; mean age, 35 years; age range, 18-73 years) who were randomly assigned to treatment with the MERM (n = 32) or the ERM (n = 30). There was a statistically significant difference between the two methods in terms of time, and the MERM can be applied much faster than ERM (1.34 ± 1.41 min vs 3.05 ± 1.93 min; p < 0.001). The intra-reduction VAS pain score was not significantly in patients who were treated with MERM (85.31 ± 10.39 vs. 78.33 ± 16.54; p = 0.122).
CONCLUSION


MERM can be an alternate method compared to the ERM for the reduction of ASD.",2020,"There was a statistically significant difference between the two methods in terms of time, and the MERM can be applied much faster than ERM (1.34 ± 1.41 min vs 3.05 ± 1.93 min; p < 0.001).","['acute anterior shoulder dislocations (ASD', '62 patients with ASD', '62 patients (52 males, 10 females; mean age, 35\u202fyears; age range, 18-73\u202fyears']","['ERM', 'new modified external rotation reduction method (MERM) with ERM', 'new modified external rotation method and external rotation method', 'MERM']","['intra-reduction VAS pain score', 'pain scores, reduction time, success rate of the reduction methods, age, sex, dislocation side, dislocation time, previous dislocations history, injury mechanism, any complications, reduction time and neurovascular examination']","[{'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0037005', 'cui_str': 'Glenohumeral Dislocation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0231462', 'cui_str': 'Lateral rotation - action (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0238395', 'cui_str': 'Male Pseudohermaphroditism'}]","[{'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0012691', 'cui_str': 'Joint Dislocations'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}]",62.0,0.020717,"There was a statistically significant difference between the two methods in terms of time, and the MERM can be applied much faster than ERM (1.34 ± 1.41 min vs 3.05 ± 1.93 min; p < 0.001).","[{'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Akcimen', 'Affiliation': 'Health Science University Antalya Training and Research Hospital, Department of Emergency Medicine, Antalya, Turkey.'}, {'ForeName': 'Cihan', 'Initials': 'C', 'LastName': 'Bedel', 'Affiliation': 'Health Science University Antalya Training and Research Hospital, Department of Emergency Medicine, Antalya, Turkey. Electronic address: cihanbedel@hotmail.com.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.07.001']
1151,30854571,The effects of gel-based manicure on pulse oximetry.,"INTRODUCTION


Pulse oximetry is the standard monitoring technique of functional oxygen saturation (SpO 2 ). As the use of fingernail polish has been described to alter SpO 2  readings, its removal is commonly recommended prior to measurement. Gel-based manicures have gained popularity in recent years due to their attractiveness and longevity. However, the removal of gel nail polish requires a specialised procedure. Valuable time and resources can be saved if removal can be avoided. To our knowledge, there are no available studies on the effect of gel-based manicures on pulse oximetry readings. Hence, we evaluated the effect with two oximeters, using different technology and wavelength combinations.
METHODS


17 healthy female adult volunteers were recruited for this single-blind randomised controlled trial. Subjects with hypothermia, hypotension, poor plethysmographic waveform and nail pathology were excluded. Colours tested were: black, purple, navy blue, green, light blue, white, yellow, orange, pink and red. Pulse oximetry was measured at 15- and 30-second intervals using two different pulse oximeters, the Philips M1191BL and Masimo SET®. Means were compared using paired t-tests.
RESULTS


Using the Masimo oximeter, light blue (ΔM = 0.97% ± 0.96%; p = 0.001) and orange (ΔM = 0.76 ± 1.17%; p = 0.016) gel nail polish resulted in a statistically significant increase from baseline SpO 2  readings. With the Philips oximeter, the limits of agreement ranged from 2% for pink to 17% for black, indicating imprecision.
CONCLUSION


Gel-based manicures can result in overestimations of actual readings, delaying detection of hypoxaemia. Gel nail polish should be routinely removed or an alternative monitoring technique sought.",2019,"With the Philips oximeter, the limits of agreement ranged from 2% for pink to 17% for black, indicating imprecision.
","['17 healthy female adult volunteers', 'Subjects with hypothermia, hypotension, poor plethysmographic waveform and nail pathology were excluded']","['gel-based manicure', 'Gel nail polish']","['overestimations of actual readings, delaying detection of hypoxaemia', 'baseline SpO2 readings', 'pulse oximetry', 'Pulse oximetry', 'black, purple, navy blue, green, light blue, white, yellow, orange, pink and red']","[{'cui': 'C0686752', 'cui_str': 'Well female adult (finding)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0450448', 'cui_str': 'Waveforms (qualifier value)'}, {'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}]","[{'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0304644', 'cui_str': 'Nail polish (substance)'}]","[{'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0034108', 'cui_str': 'Oximetry, Pulse'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0439542', 'cui_str': 'Purple color'}, {'cui': 'C1260957', 'cui_str': 'Blue color (qualifier value)'}, {'cui': 'C0332583', 'cui_str': 'Green color (qualifier value)'}, {'cui': 'C1260876', 'cui_str': 'Spirit soluble aniline blue stain'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0221205', 'cui_str': 'Yellow color (qualifier value)'}, {'cui': 'C0440277', 'cui_str': 'Oranges'}, {'cui': 'C0332585', 'cui_str': 'Pink color (qualifier value)'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}]",17.0,0.0258991,"With the Philips oximeter, the limits of agreement ranged from 2% for pink to 17% for black, indicating imprecision.
","[{'ForeName': 'Jia Lin Jacklyn', 'Initials': 'JLJ', 'LastName': 'Yek', 'Affiliation': 'Department of Anaesthesiology, Singapore General Hospital, Singapore.'}, {'ForeName': 'Hairil Rizal', 'Initials': 'HR', 'LastName': 'Abdullah', 'Affiliation': 'Department of Anaesthesiology, Singapore General Hospital, Singapore.'}, {'ForeName': 'June Pheck Suan', 'Initials': 'JPS', 'LastName': 'Goh', 'Affiliation': 'Department of Anaesthesiology, Singapore General Hospital, Singapore.'}, {'ForeName': 'Yew Weng', 'Initials': 'YW', 'LastName': 'Chan', 'Affiliation': 'Department of Anaesthesiology, Singapore General Hospital, Singapore.'}]",Singapore medical journal,['10.11622/smedj.2019031']
1152,31802404,"A Phase I, Open-Label, Parallel-Group, Single-Dose Trial of the Pharmacokinetics, Safety, and Tolerability of Cannabidiol in Subjects with Mild to Severe Renal Impairment.","INTRODUCTION


As patients who receive cannabidiol (CBD) may have co-existing renal morbidities, it is important to understand whether dose adjustments are necessary to mitigate the risk of exposure-related toxicity. This study was conducted to evaluate the pharmacokinetics, safety, and tolerability of CBD in patients with renal impairment.
METHODS


The pharmacokinetics and safety of a single oral 200 mg dose of a plant-derived pharmaceutical formulation of highly purified CBD in oral solution (Epidiolex ®  in the USA; 100 mg/mL) were assessed in subjects with mild, moderate, or severe renal impairment (n = 8/group) relative to matched subjects with normal renal function (n = 8). Blood samples were collected until 48 h post-dose and evaluated by liquid chromatography with tandem mass spectrometry. Analysis of variance was used to compare primary pharmacokinetic parameters (maximum measured plasma concentration [C max ], oral clearance of drug from plasma [CL/F], renal clearance [CL R ], area under the plasma concentration-time curve [AUC] from time zero to last measurable concentration [AUC t ], and AUC from time zero to infinity [AUC ∞ ]); descriptive analysis was used for secondary pharmacokinetic parameters (time to C max  [t max ], terminal [elimination] half-life [t ½ ], cumulative amount excreted from time zero to the last quantifiable sample [Ae last ], and fraction of the systemically available drug excreted into the urine [f e ]).
RESULTS


No statistically significant differences were observed in C max , AUC t , AUC ∞ , or t max  values between subjects with mild, moderate, or severe renal impairment and subjects with normal renal function for CBD or its major metabolites, 7-carboxy-CBD (7-COOH-CBD) and 7-hydroxy-CBD (7-OH-CBD), and minor metabolite, 6-hydroxy-CBD (6-OH-CBD); geometric mean ratio for C max  values ranged from 0.68 to 1.35. No differences were observed for other secondary parameters (Ae last  and f e ). CBD, 7-COOH-CBD, 7-OH-CBD, and 6-OH-CBD were highly protein bound (> 90%); binding was similar in all subject groups. Urine analysis for CBD recorded no appreciable amount, and thus no urinary pharmacokinetic parameters could be derived. Adverse events (AEs) affected two subjects; all five AEs were mild in severity and resolved during the trial. There were no serious AEs or discontinuations due to AEs. Laboratory, physical examination, vital sign, and 12-lead electrocardiogram findings were not clinically significant.
CONCLUSION


Renal impairment had no effect on the metabolism of CBD after a single oral 200 mg dose. CBD was generally well tolerated in subjects with varying degrees of renal function.
REGISTRATION


European Union Clinical Trials Register (EudraCT) no. 2015-002122-39.",2020,"No statistically significant differences were observed in C max , AUC t , AUC ∞ , or t max  values between subjects with mild, moderate, or severe renal impairment and subjects with normal renal function for CBD or its major metabolites, 7-carboxy-CBD (7-COOH-CBD) and 7-hydroxy-CBD (7-OH-CBD), and minor metabolite, 6-hydroxy-CBD","['subjects with mild, moderate, or severe renal impairment (n\u2009=\u20098/group) relative to matched subjects with normal renal function (n\u2009=\u20098', 'subjects with varying degrees of renal function', 'patients with renal impairment', 'Subjects with Mild to Severe Renal Impairment']","['CBD', 'cannabidiol (CBD']","['plasma concentration [C max ], oral clearance of drug from plasma [CL/F], renal clearance [CL R ], area under the plasma concentration-time curve [AUC] from time zero to last measurable concentration [AUC t ], and AUC from time zero to infinity [AUC ∞ ]); descriptive analysis was used for secondary pharmacokinetic parameters (time to C max  [t max ], terminal [elimination] half-life [t ½ ], cumulative amount excreted from time zero to the last quantifiable sample', 'CBD, 7-COOH-CBD, 7-OH-CBD, and 6-OH-CBD', 'normal renal function for CBD or its major metabolites, 7-carboxy-CBD (7-COOH-CBD) and 7-hydroxy-CBD (7-OH-CBD), and minor metabolite, 6-hydroxy-CBD', 'Blood samples', 'metabolism of CBD', 'pharmacokinetics, safety, and tolerability of CBD', 'Laboratory, physical examination, vital sign, and 12-lead electrocardiogram findings', 'C max , AUC t , AUC ∞ , or t max  values']","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0232805', 'cui_str': 'Normal renal function (finding)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0232813', 'cui_str': 'Renal clearance, function (observable entity)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0232805', 'cui_str': 'Normal renal function (finding)'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0518766'}, {'cui': 'C0430456', 'cui_str': '12 lead ECG'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.055322,"No statistically significant differences were observed in C max , AUC t , AUC ∞ , or t max  values between subjects with mild, moderate, or severe renal impairment and subjects with normal renal function for CBD or its major metabolites, 7-carboxy-CBD (7-COOH-CBD) and 7-hydroxy-CBD (7-OH-CBD), and minor metabolite, 6-hydroxy-CBD","[{'ForeName': 'Bola', 'Initials': 'B', 'LastName': 'Tayo', 'Affiliation': 'GW Research Ltd, Sovereign House, Vision Park, Histon, Cambridge, CB24 9BZ, UK.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Taylor', 'Affiliation': 'GW Research Ltd, Sovereign House, Vision Park, Histon, Cambridge, CB24 9BZ, UK.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Sahebkar', 'Affiliation': 'Greenwich Biosciences, Inc., 5750 Fleet Street, Suite 200, Carlsbad, CA, 92008, USA.'}, {'ForeName': 'Gilmour', 'Initials': 'G', 'LastName': 'Morrison', 'Affiliation': 'GW Research Ltd, Sovereign House, Vision Park, Histon, Cambridge, CB24 9BZ, UK. GMorrison@gwpharm.com.'}]",Clinical pharmacokinetics,['10.1007/s40262-019-00841-6']
1153,31259807,"PATIENT-REPORTED VISUAL FUNCTION FROM THE OCRIPLASMIN FOR TREATMENT FOR SYMPTOMATIC VITREOMACULAR ADHESION, INCLUDING MACULAR HOLE (OASIS) STUDY.","PURPOSE


To evaluate patient-reported visual function after ocriplasmin through the 25-item National Eye Institute Visual Function Questionnaire (VFQ-25) in patients with symptomatic vitreomacular adhesion/vitreomacular traction including macular hole.
METHODS


This was a prespecified analysis of a secondary endpoint from the OASIS trial. Patients received a single intravitreal injection of ocriplasmin (0.125 mg) or sham and completed the VFQ-25 questionnaire at baseline and at Months 6, 12, and 24. Clinically meaningful (≥5-point) changes from baseline were assessed.
RESULTS


Of the 220 patients enrolled, 146 received ocriplasmin and 74 received sham. At Month 24, the percentage of patients with a ≥5-point improvement from baseline in VFQ-25 composite scores was higher with ocriplasmin versus sham (51.4% vs. 30.1%, 95% confidence interval, 8.1-34.5, P = 0.003). The percentage of patients with ≥5-point worsening at Month 24 was lower with ocriplasmin versus sham (9.5% vs. 15.6%, 95% confidence interval: -15.6 to 3.5, P = 0.191). A larger percentage of patients treated with ocriplasmin versus sham experienced a ≥5-point improvement in VFQ-25 composite and subscale scores at Month 24 regardless of baseline full-thickness macular hole status.
CONCLUSION


A larger percentage of patients with symptomatic vitreomacular adhesion/vitreomacular traction reported clinically meaningful improvements in self-assessed visual function with ocriplasmin than sham.",2020,"A larger percentage of patients treated with ocriplasmin versus sham experienced a ≥5-point improvement in VFQ-25 composite and subscale scores at Month 24 regardless of baseline full-thickness macular hole status.
","['patients with symptomatic vitreomacular adhesion/vitreomacular traction including macular hole', '220 patients enrolled, 146 received']","['ocriplasmin', 'ocriplasmin through the 25-item National Eye Institute Visual Function Questionnaire (VFQ-25', 'single intravitreal injection of ocriplasmin']","['percentage of patients with ≥5-point worsening', 'self-assessed visual function', 'VFQ-25 composite scores', 'VFQ-25 composite and subscale scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C2748203', 'cui_str': 'Vitreomacular adhesion'}, {'cui': 'C0040597', 'cui_str': 'Traction'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0024441', 'cui_str': 'Macular Holes'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}]","[{'cui': 'C0066522', 'cui_str': 'ocriplasmin'}, {'cui': 'C1955969', 'cui_str': 'NEI (US)'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}]",220.0,0.272427,"A larger percentage of patients treated with ocriplasmin versus sham experienced a ≥5-point improvement in VFQ-25 composite and subscale scores at Month 24 regardless of baseline full-thickness macular hole status.
","[{'ForeName': 'Calvin', 'Initials': 'C', 'LastName': 'Mein', 'Affiliation': 'Retinal Consultants of San Antonio, San Antonio, Texas.'}, {'ForeName': 'Pravin U', 'Initials': 'PU', 'LastName': 'Dugel', 'Affiliation': 'Retinal Consultants of Arizona, Phoenix, Arizona.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Feiner', 'Affiliation': 'Hackensack University Medical Center, Hackensack, New Jersey.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Drenser', 'Affiliation': 'Associated Retinal Consultants P.C., Royal Oak, Michigan.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Miller', 'Affiliation': 'Cincinnati Eye Institute, Cincinnati, Ohio.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Benz', 'Affiliation': 'Retinal Consultants Houston, Houston, Texas.'}, {'ForeName': 'Esmeralda', 'Initials': 'E', 'LastName': 'Meunier', 'Affiliation': 'Oxurion (formerly ThromboGenics), Leuven, Belgium.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Moro', 'Affiliation': 'Oxurion (formerly ThromboGenics), Leuven, Belgium.'}, {'ForeName': 'Mitchell S', 'Initials': 'MS', 'LastName': 'Fineman', 'Affiliation': 'Mid Atlantic Retina, Philadelphia, Pennsylvania.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002599']
1154,31259813,"EFFICACY AND SAFETY OF A TREAT-AND-EXTEND REGIMEN WITH AFLIBERCEPT IN TREATMENT-NAIVE PATIENTS WITH TYPE 3 NEOVASCULARIZATION: A 52-Week, Single-Arm, Multicenter Trial.","PURPOSE


To evaluate 52-week efficacy and safety of a treat-and-extend regimen of intravitreal aflibercept 2 mg on treatment-naive Type 3 neovascularization lesions.
METHODS


Phase IV, prospective, open-label, single-arm, multicenter trial including patients with untreated Stage I/II Type 3 neovascularization lesions and baseline best-corrected visual acuity between 78 and 23 Early Treatment Diabetic Retinopathy Study letters. Primary endpoint: mean change in best-corrected visual acuity from baseline at 52 weeks.
RESULTS


Thirty-two eyes from 32 patients were included (mean ± SD age: 78.2 ± 7.7 years, 68.8% females, baseline best-corrected visual acuity: 57.9 ± 15.4 [Snellen fraction 20/70]). Best-corrected visual acuity increased by 10.5 ± 15.9 Early Treatment Diabetic Retinopathy Study letters at Week 52 (P = 0.0001). The mean foveal and choroidal thickness decreased by 129.1 ± 80.1 µm (P < 0.0001) and 64.3 ± 96.5 (P = 0.0001), respectively. The proportion of patients with intraretinal/subretinal fluid decreased from 28 (87.5%) at baseline to 3 (11.5%) at Week 52 (P < 0.0001). Pigment epithelial detachment and lesion area showed nonsignificant changes over 52 weeks. The mean number of injections was 8.0 ± 2.0. Seven (21.9%) patients experienced treatment-related adverse events and two (6.3%) experienced serious adverse events; one (3.1%) ocular serious adverse event requiring treatment withdrawal, endophthalmitis, and one (3.1%) nonocular spontaneously resolved serious adverse event, palpitations. One (3.1%) patient experienced an APTC ATE: nonfatal stroke not related to trial treatment.
CONCLUSION


A treat-and-extend regimen of aflibercept improves visual acuity and retinal edema in eyes with Type 3 neovascularization over 52 weeks with good tolerability.",2020,Best-corrected visual acuity increased by 10.5 ± 15.9 Early Treatment Diabetic Retinopathy Study letters at Week 52 (P = 0.0001).,"['eyes with Type 3 neovascularization over 52 weeks with good tolerability', 'Thirty-two eyes from 32 patients were included (mean ± SD age: 78.2 ± 7.7 years, 68.8% females, baseline best-corrected visual acuity: 57.9 ± 15.4 [Snellen fraction 20/70', 'patients with untreated Stage I/II Type 3 neovascularization lesions and baseline best-corrected visual acuity between 78 and 23 Early Treatment Diabetic Retinopathy Study letters']","['aflibercept', 'intravitreal aflibercept']","['Best-corrected visual acuity', 'mean foveal and choroidal thickness', 'adverse events', 'proportion of patients with intraretinal/subretinal fluid', 'mean change in best-corrected visual acuity', 'serious adverse events', 'visual acuity and retinal edema', 'serious adverse event, palpitations']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0027686', 'cui_str': 'Pathologic Neovascularization'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517860', 'cui_str': '7.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C4517579', 'cui_str': '15.4 (qualifier value)'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0441731', 'cui_str': 'Type 3 (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}]","[{'cui': 'C1134659', 'cui_str': 'aflibercept'}]","[{'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1720732', 'cui_str': 'Subretinal fluid'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0242420', 'cui_str': 'Retinal Edema'}, {'cui': 'C0030252', 'cui_str': 'Palpitations (finding)'}]",32.0,0.115424,Best-corrected visual acuity increased by 10.5 ± 15.9 Early Treatment Diabetic Retinopathy Study letters at Week 52 (P = 0.0001).,"[{'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Arias', 'Affiliation': 'Department of Ophthalmology, Hospital Universitari de Bellvitge, Barcelona, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Cervera', 'Affiliation': 'Department of Ophthalmology, Hospital General de València, València, Spain.'}, {'ForeName': 'Jaume Crespí', 'Initials': 'JC', 'LastName': 'Vilimelis', 'Affiliation': 'Department of Ophthalmology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'José Juan', 'Initials': 'JJ', 'LastName': 'Escobar', 'Affiliation': 'Department of Ophthalmology, Hospital Dos de Maig, Barcelona, Spain.'}, {'ForeName': 'Antonio Gómez', 'Initials': 'AG', 'LastName': 'Escobar', 'Affiliation': 'Department of Ophthalmology, Hospital Universitario Virgen de la Macarena, Sevilla, Spain.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Zapata', 'Affiliation': ""Department of Ophthalmology, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002582']
1155,31249394,Urine protein:creatinine ratio vs 24-hour urine protein for proteinuria management: analysis from the phase 3 REFLECT study of lenvatinib vs sorafenib in hepatocellular carcinoma.,"BACKGROUND


Proteinuria monitoring is required in patients receiving lenvatinib, however, current methodology involves burdensome overnight urine collection.
METHODS


To determine whether the simpler urine protein:creatinine ratio (UPCR) calculated from spot urine samples could be accurately used for proteinuria monitoring in patients receiving lenvatinib, we evaluated the correlation between UPCR and 24-hour urine protein results from the phase 3 REFLECT study. Paired data (323 tests, 154 patients) were analysed.
RESULTS


Regression analysis showed a statistically significant correlation between UPCR and 24-hour urine protein (R 2 : 0.75; P < 2 × 10 -16 ). A UPCR cut-off value of 2.4 had 96.9% sensitivity, 82.5% specificity for delineating between grade 2 and 3 proteinuria. Using this UPCR cut-off value to determine the need for further testing could reduce the need for 24-hour urine collection in ~74% of patients.
CONCLUSION


Incorporation of UPCR into the current algorithm for proteinuria management can enable optimisation of lenvatinib treatment, while minimising patient inconvenience.
CLINICAL TRIAL REGISTRATION


NCT01761266.",2019,"A UPCR cut-off value of 2.4 had 96.9% sensitivity, 82.5% specificity for delineating between grade 2 and 3 proteinuria.",['hepatocellular carcinoma'],['lenvatinib vs sorafenib'],['UPCR and 24-hour urine protein'],"[{'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}]","[{'cui': 'C2986924', 'cui_str': 'lenvatinib'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C1305628', 'cui_str': 'Urine protein (substance)'}]",,0.0399609,"A UPCR cut-off value of 2.4 had 96.9% sensitivity, 82.5% specificity for delineating between grade 2 and 3 proteinuria.","[{'ForeName': 'Thomas R Jeffry', 'Initials': 'TRJ', 'LastName': 'Evans', 'Affiliation': 'University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow, UK. j.evans@beatson.gla.ac.uk.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Finn', 'Affiliation': 'David Geffen School of Medicine, UCLA Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Kwang-Hyub', 'Initials': 'KH', 'LastName': 'Han', 'Affiliation': 'Severance Hospital, Yonsei University, Seoul, South Korea.'}, {'ForeName': 'Ann-Lii', 'Initials': 'AL', 'LastName': 'Cheng', 'Affiliation': 'National Taiwan University Hospital and National Taiwan University Cancer Center, Taipei, Taiwan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ikeda', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Silvija', 'Initials': 'S', 'LastName': 'Kraljevic', 'Affiliation': 'Former employee of Eisai Ltd, Hatfield, UK.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Ren', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Corina E', 'Initials': 'CE', 'LastName': 'Dutcus', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Piscaglia', 'Affiliation': 'Unit of Internal Medicine, University of Bologna, S.Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Max W', 'Initials': 'MW', 'LastName': 'Sung', 'Affiliation': 'Tisch Cancer Institute at Mount Sinai, New York, NY, USA.'}]",British journal of cancer,['10.1038/s41416-019-0506-6']
1156,31046165,Day clinic vs. hospital care of pneumonia and severe malnutrition in children under five: a randomised trial.,"OBJECTIVES


To evaluate the clinical outcomes and costs of managing pneumonia and severe malnutrition in a day clinic (DC) management model (outpatient) vs. hospital care (inpatient).
METHODS


Randomised clinical trial where children aged 2 months to 5 years with pneumonia and severe malnutrition were randomly allocated to DC or inpatient hospital care. We used block randomisation of variable length from 8 to 20 and produced computer-generated random numbers that were assigned to one of the two interventions. Successful management was defined as resolution of clinical signs of pneumonia and being discharged from the model of care (DC or hospital) without need for referral to a hospital (DC), or referral to another hospital. All the children in both DC and hospital received intramuscular ceftriaxone, daily nutrition support and micronutrients.
RESULTS


Four hundred and seventy children were randomly assigned to either DC or hospital care. Successful management was achieved for 184 of 235 (78.3%) by DC alone, vs. 201 of 235 (85.5%) by hospital inpatient care [RR (95% CI) = 0.79 (0.65-0.97), P = 0.02]. During 6 months of follow-up, 30/235 (12.8%) in the DC group and 36/235 (15.3%) required readmission to hospital in the hospital care group [RR (95% CI) = 0.89 (0.67-1.18), P = 0.21]. The average overall healthcare and societal cost was 34% lower in DC (US$ 188 ± 11.7) than in hospital (US$ 285 ± 13.6) (P < 0.001), and costs for households were 33% lower.
CONCLUSIONS


There was a 7% greater probability of successful management of pneumonia and severe malnutrition when inpatient hospital care rather than the outpatient day clinic care was the initial method of care. However, where timely referral mechanisms were in place, 94% of children with pneumonia and severe malnutrition were successfully managed initially in a day clinic, and costs were substantially lower than with hospital admission.",2019,"Successful management was achieved for 184 of 235 (78.3%) by DC alone, vs. 201 of 235 (85.5%) by hospital inpatient care [RR (95% CI) = 0.79 (","['Four hundred and seventy children', 'managing pneumonia and severe malnutrition in a day clinic (DC) management model (outpatient) vs. hospital care (inpatient', 'Day clinic vs. hospital care of pneumonia and severe malnutrition in children under five', 'children aged 2\xa0months to 5\xa0years with pneumonia and severe malnutrition']","['DC or inpatient hospital care', 'ceftriaxone, daily nutrition support and micronutrients', 'DC or hospital care']","['readmission to hospital', 'Successful management', 'average overall healthcare and societal cost', 'probability of successful management of pneumonia and severe malnutrition', 'hospital inpatient care [RR']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0311276', 'cui_str': 'Severe malnutrition'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}]","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0311276', 'cui_str': 'Severe malnutrition'}, {'cui': 'C0239966', 'cui_str': 'Hospital patient (finding)'}]",470.0,0.130612,"Successful management was achieved for 184 of 235 (78.3%) by DC alone, vs. 201 of 235 (85.5%) by hospital inpatient care [RR (95% CI) = 0.79 (","[{'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Ashraf', 'Affiliation': 'icddr,b, International Centre for Diarrhoeal Disease Research, Bangladesh.'}, {'ForeName': 'Nur H', 'Initials': 'NH', 'LastName': 'Alam', 'Affiliation': 'icddr,b, International Centre for Diarrhoeal Disease Research, Bangladesh.'}, {'ForeName': 'Marufa', 'Initials': 'M', 'LastName': 'Sultana', 'Affiliation': 'icddr,b, International Centre for Diarrhoeal Disease Research, Bangladesh.'}, {'ForeName': 'Selina A', 'Initials': 'SA', 'LastName': 'Jahan', 'Affiliation': 'icddr,b, International Centre for Diarrhoeal Disease Research, Bangladesh.'}, {'ForeName': 'Nurshad', 'Initials': 'N', 'LastName': 'Begum', 'Affiliation': 'icddr,b, International Centre for Diarrhoeal Disease Research, Bangladesh.'}, {'ForeName': 'Sharmin', 'Initials': 'S', 'LastName': 'Farzana', 'Affiliation': 'icddr,b, International Centre for Diarrhoeal Disease Research, Bangladesh.'}, {'ForeName': 'Mohammod J', 'Initials': 'MJ', 'LastName': 'Chisti', 'Affiliation': 'icddr,b, International Centre for Diarrhoeal Disease Research, Bangladesh.'}, {'ForeName': 'Mohiuddin', 'Initials': 'M', 'LastName': 'Kamal', 'Affiliation': 'Radda Maternal and Child Health Family Planning Centre, Dhaka, Bangladesh.'}, {'ForeName': 'Abu', 'Initials': 'A', 'LastName': 'Shamsuzzaman', 'Affiliation': 'Institute of Child Health and Shishu, Sasthya Foundation Hospital, Dhaka, Bangladesh.'}, {'ForeName': 'Tahmeed', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'icddr,b, International Centre for Diarrhoeal Disease Research, Bangladesh.'}, {'ForeName': 'Jahangir A M', 'Initials': 'JAM', 'LastName': 'Khan', 'Affiliation': 'icddr,b, International Centre for Diarrhoeal Disease Research, Bangladesh.'}, {'ForeName': 'George J', 'Initials': 'GJ', 'LastName': 'Fuchs', 'Affiliation': 'Department of Pediatrics, University of Kentucky College of Medicine, Lexington, Kentucky, USA.'}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Duke', 'Affiliation': 'Centre for International Child Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Niklaus', 'Initials': 'N', 'LastName': 'Gyr', 'Affiliation': 'Faculty of Medicine, University of Basel, Basel, Switzerland.'}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13242']
1157,31256250,Accelerated Skills Acquisition Protocol (ASAP) in optimizing robotic surgical simulation training: a prospective randomized study.,"PURPOSE


To assess the efficacy of an accelerated proficiency-based training protocol in robotic simulation practice in delivering durable proficiency compared to conventional training methods.
METHODS


Novice medical students (n = 16) were randomized into either the accelerated skills acquisition protocol (ASAP) or conventional training protocol (CTP). Subjects were trained to proficiency on the da Vinci Skills Simulator (dVSS) by an expert trainer. Differences in the repetitions required to achieve proficiency in two simple and two complex virtual reality (VR) training tasks were assessed as the primary outcome measure. Transfer of the acquired skills to two other non-practiced tasks was assessed immediately and prospectively followed through to 3, 6 and 12 months in the two groups. Retention of the practiced tasks was assessed along the same timeframe.
RESULTS


Subjects in the ASAP group acquired proficiency significantly faster in three of the four training tasks: camera control (p = 0.0002), suture sponge (p < 0.0001), ring walk3 (p < 0.0001), and peg board (p = 0.6936). When assessing transfer of skills, there were no significant differences between the two groups: Ring rail 3 (p = 0.6807) and Tubes (p = 0.2240). When assessing retention of skills at 3, 6 and 12 months, for all 6 tasks, no significant differences were seen between the ASAP and CTP groups.
CONCLUSION


ASAP is proven to be an efficient approach for delivering proficiency in robotic VR simulation training. The results are durable when compared to conventional simulation training methods. The findings may have significant implications in the design of robotic VR simulation curricula.",2020,"When assessing retention of skills at 3, 6 and 12 months, for all 6 tasks, no significant differences were seen between the ASAP and CTP groups.
",['Novice medical students (n\u2009=\u200916'],"['accelerated proficiency-based training protocol', 'Accelerated Skills Acquisition Protocol (ASAP', 'accelerated skills acquisition protocol (ASAP) or conventional training protocol (CTP', 'da Vinci Skills Simulator (dVSS) by an expert trainer']",['suture sponge'],"[{'cui': 'C0038495', 'cui_str': 'Students, Medical'}]","[{'cui': 'C0521110', 'cui_str': 'Accelerated (contextual qualifier) (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0010734', 'cui_str': 'CRPPP'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C1705741', 'cui_str': 'Sponge (basic dose form)'}]",16.0,0.0239299,"When assessing retention of skills at 3, 6 and 12 months, for all 6 tasks, no significant differences were seen between the ASAP and CTP groups.
","[{'ForeName': 'Pratik M S', 'Initials': 'PMS', 'LastName': 'Gurung', 'Affiliation': 'Department of Urology, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Campbell', 'Affiliation': 'Department of Urology, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Bokai', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Jean V', 'Initials': 'JV', 'LastName': 'Joseph', 'Affiliation': 'Department of Urology, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Ahmed E', 'Initials': 'AE', 'LastName': 'Ghazi', 'Affiliation': 'Department of Urology, University of Rochester Medical Center, Rochester, NY, USA. ahmed_ghazi@urmc.rochester.edu.'}]",World journal of urology,['10.1007/s00345-019-02858-9']
1158,31256715,Lifejackets and Lobstermen: Giving Safety Equipment a Competitive Advantage.,"Background : Falls overboard are the most frequent cause of death in the Northeast lobster fishing industry. National Institute for Occupational Safety and Health (NIOSH) surveillance indicates every victim of a fall overboard who has been found was not wearing a lifejacket. Preliminary research conducted in Maine and Massachusetts indicates lifejacket use is relatively uncommon among lobstermen due to barriers such as comfort, practicality, and social norms. Methods : This study highlights an initiative to: (1) trial various lifejacket designs with lobstermen; (2) identify the most popular designs; and (3) identify other features that could encourage use of lifejackets. In 2017, nine designs were trialed with lobstermen in Maine and Massachusetts during the winter and summer fishing seasons. Participants were recruited dockside, and lifejackets were randomly assigned. Participants completed surveys at 1 week and 4 weeks to assess positive and negative design features and to understand the importance of survival technology that can be used in conjunction with lifejackets. Results : 181 lobstermen in Maine and Massachusetts agreed to participate. Recruitment rates were 90.5%, while the survey completion rate was 88.4%. Survey results identified no clear preference for a specific lifejacket design; however, the ability to choose from many options appeared to be an important factor. Conclusion : Previous studies have indicated that lifejacket preferences are fisheries specific. In the Northeast lobster fishery, however, individual preferences varied. Our research demonstrates that a range of devices covering different buoyancies, wear type, and retrieval systems should be made more available to lobstermen.",2019,"Survey results identified no clear preference for a specific lifejacket design; however, the ability to choose from many options appeared to be an important factor.  ","['Participants were recruited dockside, and lifejackets were randomly assigned']",[' '],"['Recruitment rates', 'survey completion rate']","[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]",[],"[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",9.0,0.034435,"Survey results identified no clear preference for a specific lifejacket design; however, the ability to choose from many options appeared to be an important factor.  ","[{'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Sorensen', 'Affiliation': 'Northeast Center for Occupational Health and Safety: Agriculture, Forestry, and Fishing, Cooperstown, NY, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Weil', 'Affiliation': 'Northeast Center for Occupational Health and Safety: Agriculture, Forestry, and Fishing, Cooperstown, NY, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Echard', 'Affiliation': 'Northeast Center for Occupational Health and Safety: Agriculture, Forestry, and Fishing, Cooperstown, NY, USA.'}, {'ForeName': 'Liane', 'Initials': 'L', 'LastName': 'Hirabayashi', 'Affiliation': 'Northeast Center for Occupational Health and Safety: Agriculture, Forestry, and Fishing, Cooperstown, NY, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Scribani', 'Affiliation': 'The Bassett Research Institute, Bassett Healthcare Network, Cooperstown, NY, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Jenkins', 'Affiliation': 'The Bassett Research Institute, Bassett Healthcare Network, Cooperstown, NY, USA.'}]",Journal of agromedicine,['10.1080/1059924X.2019.1635935']
1159,31130060,Effectiveness of Foot Orthoses Versus Corticosteroid Injection for Plantar Heel Pain: The SOOTHE Randomized Clinical Trial.,"BACKGROUND


Plantar heel pain is a common foot complaint that causes significant disability and poorer health-related quality of life. Foot orthoses and corticosteroid injection are effective treatments for plantar heel pain; however, it is unclear whether one is more effective than the other.
OBJECTIVE


The aim of this trial was to compare the effectiveness of foot orthoses and corticosteroid injection for plantar heel pain.
METHODS


In this parallel-group, assessor-blinded, randomized clinical trial, participants received prefabricated, arch-contouring foot orthoses or a single ultrasound-guided corticosteroid injection. The primary outcome measure was the foot pain subscale of the Foot Health Status Questionnaire at 4 and 12 weeks.
RESULTS


One hundred three participants aged 21 to 72 years (63 female) with plantar heel pain were recruited from the community and received an intervention. For the primary outcome of foot pain, corticosteroid injection was more effective at week 4 (adjusted mean difference, 8.2 points; 95% confidence interval: 0.6, 15.8 points). However, foot orthoses were more effective at week 12 (adjusted mean difference, 8.5 points; 95% confidence interval: 0.2, 16.8 points). Although these findings were statistically significant, the differences between the interventions did not meet the previously calculated minimal important difference value of 12.5 points.
CONCLUSION


Corticosteroid injection is more effective than foot orthoses at week 4, but this effect does not last; and appropriately contoured foot orthoses are more effective than corticosteroid injection at week 12. However, patients may not notice a clinically worthwhile difference between the interventions.
LEVEL OF EVIDENCE


Therapy, level 1b.  J Orthop Sports Phys Ther 2019;49(7):491-500. Epub 26 May 2019. doi:10.2519/jospt.2019.8807 .",2019,"However, foot orthoses were more effective at week 12 (adjusted mean difference, 8.5 points; 95% confidence interval: 0.2, 16.8 points).","['Plantar Heel Pain', 'Epub 26', 'plantar heel pain', 'One hundred three participants aged 21 to 72 years (63 female) with plantar heel pain were recruited from the community and received an intervention']","['Foot orthoses and corticosteroid injection', 'prefabricated, arch-contouring foot orthoses or a single ultrasound-guided corticosteroid injection', 'Foot Orthoses Versus Corticosteroid Injection', 'foot orthoses and corticosteroid injection', 'Corticosteroid injection']","['foot pain subscale of the Foot Health Status Questionnaire', 'foot pain, corticosteroid injection']","[{'cui': 'C0231786', 'cui_str': 'Plantar heel pain (finding)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C1283250', 'cui_str': 'Foot Orthotic Devices'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0016512', 'cui_str': 'Foot pain (finding)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]",103.0,0.48506,"However, foot orthoses were more effective at week 12 (adjusted mean difference, 8.5 points; 95% confidence interval: 0.2, 16.8 points).","[{'ForeName': 'Glen A', 'Initials': 'GA', 'LastName': 'Whittaker', 'Affiliation': ''}, {'ForeName': 'Shannon E', 'Initials': 'SE', 'LastName': 'Munteanu', 'Affiliation': ''}, {'ForeName': 'Hylton B', 'Initials': 'HB', 'LastName': 'Menz', 'Affiliation': ''}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Gerrard', 'Affiliation': ''}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Elzarka', 'Affiliation': ''}, {'ForeName': 'Karl B', 'Initials': 'KB', 'LastName': 'Landorf', 'Affiliation': ''}]",The Journal of orthopaedic and sports physical therapy,['10.2519/jospt.2019.8807']
1160,31369771,Intralesional versus intramuscular bivalent human papillomavirus vaccine in the treatment of recalcitrant common warts.,"BACKGROUND


Despite the availability of different therapeutic modalities, treatment of recalcitrant common warts is still challenging. Cervarix (GlaxoSmithKline, Brentford, UK), a recombinant bivalent human papillomavirus (HPV) vaccine, has shown promising efficacy in the treatment of warts.
OBJECTIVES


To evaluate the beneficial effects and tolerability of intramuscular versus intralesional bivalent HPV vaccine in the treatment of recalcitrant common warts.
METHODS


The study included 44 adult patients with multiple recalcitrant common warts; 22 patients received intramuscular injection of bivalent HPV vaccine at 0, 1, and 6 months or until complete clearance of warts, and the other 22 patients received intralesional injection of 0.1 to 0.3 mL of bivalent HPV vaccine into the largest wart at 2-week intervals until complete clearance or for a maximum of 6 sessions.
RESULTS


Complete clearance of warts was observed in 18 patients (81.8%) of the intralesional group and 14 patients (63.3%) of the intramuscular group; however, the difference was not statistically significant. Adverse effects were transient and insignificant, and no recurrence was reported in either group.
LIMITATIONS


Small study sample and different dosing schedules.
CONCLUSIONS


Bivalent HPV vaccine, particularly by intralesional injection, seems to be a potential therapeutic option for the treatment of multiple recalcitrant common warts.",2020,"RESULTS


Complete clearance of warts was observed in 18 patients (81.8%) of the intralesional group and in 14 patients (63.3%) of the intramuscular group; however, the difference was not statistically significant.","['44 adult patients with multiple recalcitrant common warts; 22 patients', 'recalcitrant common warts']","['Intralesional versus intramuscular bivalent human papillomavirus vaccine', 'recombinant bivalent human papillomavirus (HPV) vaccine', 'intralesional bivalent HPV vaccine', 'intramuscular bivalent HPV vaccine at 0, 1, and 6 months or until complete clearance of warts and the other 22 patients were intralesionally injected with 0.1 to 0.3 ml of bivalent HPV vaccine']","['Complete clearance of warts', 'Adverse effects']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0043037', 'cui_str': 'Verruca vulgaris (disorder)'}]","[{'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C3665596', 'cui_str': 'Verruca'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C3665596', 'cui_str': 'Verruca'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",44.0,0.0738268,"RESULTS


Complete clearance of warts was observed in 18 patients (81.8%) of the intralesional group and in 14 patients (63.3%) of the intramuscular group; however, the difference was not statistically significant.","[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Nofal', 'Affiliation': 'Dermatology Department, Zagazig University, Zagazig, Egypt. Electronic address: ahmadnofal5@hotmail.com.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Marei', 'Affiliation': 'Microbiology and Immunology Department, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Al-Shimaa M', 'Initials': 'AM', 'LastName': 'Ibrahim', 'Affiliation': 'Dermatology Department, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Eman', 'Initials': 'E', 'LastName': 'Nofal', 'Affiliation': 'Dermatology Department, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Manal', 'Initials': 'M', 'LastName': 'Nabil', 'Affiliation': 'Dermatology Department, Zagazig University, Zagazig, Egypt.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.07.070']
1161,31262657,"Regorafenib dose-optimisation in patients with refractory metastatic colorectal cancer (ReDOS): a randomised, multicentre, open-label, phase 2 study.","BACKGROUND


Regorafenib confers an overall survival benefit in patients with refractory metastatic colorectal cancer; however, the adverse event profile of regorafenib has limited its use. Despite no supportive evidence, various dosing schedules are used clinically to alleviate toxicities. This study evaluated the safety and activity of two regorafenib dosing schedules.
METHODS


In this randomised, multicentre, open-label, phase 2 study done in 39 outpatient cancer centres in the USA, adults aged 18 years or older with histologically or cytologically confirmed advanced or metastatic adenocarcinoma of the colon or rectum that was refractory to previous standard therapy, including EGFR inhibitors if KRAS wild-type, were enrolled. Eligible patients had an Eastern Cooperative Oncology Group performance status of 0-1 and had no previous treatment with regorafenib. Patients were randomly assigned (1:1:1:1) into four groups with two distinct regorafenib dosing strategies and two clobetasol usage plans, stratified by hospital. Regorafenib dosing strategies were a dose-escalation strategy (starting dose 80 mg/day orally with weekly escalation, per 40 mg increment, to 160 mg/day regorafenib) if no significant drug-related adverse events occurred and a standard-dose strategy (160 mg/day orally) for 21 days of a 28-day cycle. Clobetasol usage plans (0·05% clobetasol cream twice daily applied to palms and soles) were either pre-emptive or reactive. After randomisation to the four preplanned groups, using the Pocock and Simon dynamic allocation procedures stratified by the treating hospitals, we formally tested the interaction between the two interventions, dosing strategy and clobetasol usage. Given the absence of a significant interaction (p=0·74), we decided to pool the data for the pre-emptive and reactive treatment with clobetasol and compared the two dosing strategies (dose escalation vs standard dose). The primary endpoint was the proportion of evaluable patients (defined as those who were eligible, consented, and received any protocol treatment) initiating cycle 3 and was analysed per protocol. Superiority for dose escalation was declared if the one-sided p value with Fisher's exact test was less than 0·2. This trial is registered with ClinicalTrials.gov, number NCT02368886. This study is fully accrued but remains active.
FINDINGS


Between June 2, 2015, and June 22, 2017, 123 patients were randomly assigned to treatment, of whom 116 (94%) were evaluable. The per-protocol population consisted of 54 patients in the dose-escalation group and 62 in the standard-dose group. At data cutoff on July 24, 2018, median follow-up was 1·18 years (IQR 0·98-1·57). The primary endpoint was met: 23 (43%, 95% CI 29-56) of 54 patients in the dose-escalation group initiated cycle 3 versus 16 (26%, 15-37) of 62 patients in the standard-dose group (one-sided p=0·043). The most common grade 3-4 adverse events were fatigue (seven [13%] patients in the dose-escalation group vs 11 [18%] in the standard-dose group), hand-foot skin reaction (eight [15%] patients vs ten [16%] patients), abdominal pain (nine [17%] patients vs four [6%] patients), and hypertension (four [7%] patients vs nine [15%] patients). 14 patients had at least one drug-related serious adverse event: six patients in the dose-escalation group and eight patients in the standard-dose group. There was one probable treatment-related death in the standard-dose group (myocardial infarction).
INTERPRETATION


The dose-escalation dosing strategy represents an alternative approach for optimising regorafenib dosing with comparable activity and lower incidence of adverse events and could be implemented in clinical practice on the basis of these data.
FUNDING


Bayer HealthCare Pharmaceuticals.",2019,"Given the absence of a significant interaction (p=0·74), we decided to pool the data for the pre-emptive and reactive treatment with clobetasol and compared the two dosing strategies (dose escalation vs standard dose).","['Eligible patients had an Eastern Cooperative Oncology Group performance status of 0-1 and had no previous treatment with regorafenib', '39 outpatient cancer centres in the USA, adults aged 18 years or older with histologically or cytologically confirmed advanced or metastatic adenocarcinoma of the colon or rectum that was refractory to previous standard therapy, including EGFR inhibitors if KRAS wild-type, were enrolled', 'patients with refractory metastatic colorectal cancer', '14 patients had at least one drug-related serious adverse event: six patients in the dose-escalation group and eight patients in the standard-dose group', 'Between June 2, 2015, and June 22, 2017, 123 patients were randomly assigned to treatment, of whom 116 (94%) were evaluable', 'patients with refractory metastatic colorectal cancer (ReDOS']","['Clobetasol usage plans (0·05% clobetasol cream', 'Regorafenib dose-optimisation']","['hand-foot skin reaction', 'abdominal pain', 'death', 'hypertension', 'overall survival benefit', 'safety and activity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0334277', 'cui_str': 'Adenocarcinoma, metastatic (morphologic abnormality)'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0034896', 'cui_str': 'Rectum'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}]","[{'cui': 'C0008992', 'cui_str': 'Clobetasol'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction (observable entity)'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",123.0,0.101255,"Given the absence of a significant interaction (p=0·74), we decided to pool the data for the pre-emptive and reactive treatment with clobetasol and compared the two dosing strategies (dose escalation vs standard dose).","[{'ForeName': 'Tanios S', 'Initials': 'TS', 'LastName': 'Bekaii-Saab', 'Affiliation': 'Division of Medical Oncology, Mayo Clinic, Phoenix, AZ, USA. Electronic address: bekaii-saab.tanios@mayo.edu.'}, {'ForeName': 'Fang-Shu', 'Initials': 'FS', 'LastName': 'Ou', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Ahn', 'Affiliation': 'Division of Medical Oncology, Mayo Clinic, Phoenix, AZ, USA.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Boland', 'Affiliation': 'Department of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA.'}, {'ForeName': 'Kristen K', 'Initials': 'KK', 'LastName': 'Ciombor', 'Affiliation': 'Division of Hematology, Department of Medicine, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Heying', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Travis J', 'Initials': 'TJ', 'LastName': 'Dockter', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Nisha L', 'Initials': 'NL', 'LastName': 'Jacobs', 'Affiliation': 'Minnesota Oncology, Coon Rapids, MN, USA.'}, {'ForeName': 'Boris C', 'Initials': 'BC', 'LastName': 'Pasche', 'Affiliation': 'Department of Hematology and Oncology, Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, NC, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Cleary', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Meyers', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Rodwige J', 'Initials': 'RJ', 'LastName': 'Desnoyers', 'Affiliation': 'Department of Hematology and Oncology, Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, NC, USA.'}, {'ForeName': 'Jeannine S', 'Initials': 'JS', 'LastName': 'McCune', 'Affiliation': 'Department of Pharmaceutics, School of Pharmacy, University of Washington, Seattle, WA, USA; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Pedersen', 'Affiliation': 'Division of Oncology, Department of Medicine, Washington University, St Louis, MO, USA.'}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Barzi', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'E Gabriela', 'Initials': 'EG', 'LastName': 'Chiorean', 'Affiliation': 'Department of Population Sciences, School of Medicine, University of Washington, Seattle, WA, USA; Department of Medicine, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Sloan', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Mario E', 'Initials': 'ME', 'LastName': 'Lacouture', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Grothey', 'Affiliation': 'West Cancer Center, Memphis, TN, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30272-4']
1162,31199173,Cost per response for guselkumab versus adalimumab in the United States using data from a head-to-head trial in moderate-to-severe plaque psoriasis.,"Aims:  To estimate annual cost per response (CPR) in the US and number needed to treat (NNT) among patients receiving guselkumab or adalimumab treatment for moderate-to-severe plaque psoriasis (PsO). Materials and methods:  Results from VOYAGE 1, a double-blind, placebo-controlled, head-to-head, 48-week study of guselkumab compared with adalimumab in patients with moderate-to-severe PsO were used to estimate annual CPR for Psoriasis Area and Severity Index (PASI) 75, 90, and 100 responses. Drug dosing followed US label recommendations and drug costs were based on US annual wholesale acquisition costs. Number needed to treat (NNT) and annual CPR analyses were estimated, and week 48 response rates were assumed to be maintained for both the induction and maintenance years. Results:  Week-48 PASI 90 response rates were 76.3% for guselkumab and 47.9% for adalimumab. The CPR for PASI 90 in the induction year for guselkumab was $113,861 vs $151,226 for adalimumab. Both drugs had lower CPRs for PASI 90 in the maintenance year: $85,395 for guselkumab and $140,424 for adalimumab for adalimumab. The NNT for a PASI 90 response was 1.3 for guselkumab and 2.1 for adalimumab; CPRs and NNT were also lower for guselkumab than for adalimumab for PASI 75 and PASI 100 for both induction and maintenance years. Limitations and conclusions:  In this analysis, extrapolating 48-week results from a single head-to-head study, guselkumab was more cost-effective with lower NNT than adalimumab in both the induction and maintenance years for PASI 75, PASI 90, and PASI 100 responses.",2019,"Both drugs had lower CPRs for PASI 90 in the maintenance year: $85,395 for guselkumab and $140,424 for adalimumab for adalimumab.","['patients receiving guselkumab or adalimumab treatment for moderate-to-severe plaque psoriasis (PsO', 'patients with moderate-to-severe PsO']","['adalimumab', 'guselkumab versus adalimumab', 'placebo', 'guselkumab']","['Week-48 PASI 90 response rates', 'Number needed to treat (NNT) and annual CPR analyses']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",,0.0606369,"Both drugs had lower CPRs for PASI 90 in the maintenance year: $85,395 for guselkumab and $140,424 for adalimumab for adalimumab.","[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Teeple', 'Affiliation': 'Real World Value and Evidence, Janssen Scientific Affairs, LLC, Horsham, PA, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Muser', 'Affiliation': 'Real World Value and Evidence, Janssen Scientific Affairs, LLC, Horsham, PA, USA.'}]",Journal of medical economics,['10.1080/13696998.2019.1632204']
1163,31220875,Oral 5-aminosalicylic acid for maintenance of surgically-induced remission in Crohn's disease.,"BACKGROUND


Crohn's disease (CD) is a chronic inflammatory disorder that can involve any part of the gastrointestinal tract. 5-Aminosalicylates (5-ASAs) are locally acting, anti-inflammatory compounds that reduce inflammation of the colonic mucosa with release profiles that vary among various commercially available formulations. This updated Cochrane review summarizes current evidence on the use of 5-ASA formulations for maintenance of surgically-induced remission in CD.
OBJECTIVES


To assess the efficacy and safety of 5-ASA agents for the maintenance of surgically-induced remission in CD.
SEARCH METHODS


We searched MEDLINE, Embase, CENTRAL, the Cochrane IBD Group Specialized Register from inception to 16 July 2018. We also searched references, conference abstracts, and trials registers.
SELECTION CRITERIA


Randomised controlled trials (RCTs) that included participants with CD in remission following surgery and compared 5-ASAs to no treatment, placebo or any other active intervention with duration of at least three months were considered for inclusion.
DATA COLLECTION AND ANALYSIS


We used standard methodological procedures expected by Cochrane. The primary outcome was clinical relapse. Secondary outcomes included endoscopic recurrence, radiologic and surgical relapse, adverse events, serious adverse events and withdrawal due to adverse events.
MAIN RESULTS


Fourteen RCTs (1867 participants) were included in the review. Participants (15 to 70 years) were recruited from gastroenterology hospitals and medical clinics in Europe and North America and followed up between 3 and 72 months. The risk of bias was assessed as 'low' in one study, 'unclear' in seven and as 'high' in six.At 12 months, 36% (20/55) of participants in the 5-ASA group experienced clinical relapse compared to 51% (28/55) in the no treatment control group (RR 0.71, 95% CI 0.46 to 1.10; low certainty evidence). Moderate certainty evidence suggests that 5-ASAs are more effective for preventing clinical relapse than placebo. During a follow-up period of 12 to 72 months, 36% (131/361) of 5-ASA participants relapsed compared to 43% (160/369) of placebo participants (RR 0.83, 95% CI 0.72 to 0.96; I² = 0%; moderate certainty evidence). At 12 months, 17% (17/101) of the 4 g/day mesalamine group relapsed compared to 26% (27/105) of the 2.4 g/day group (RR 0.65, 95% CI 0.38 to 1.13; moderate certainty evidence). There was no evidence of a difference in clinical relapse rates when 5-ASA compounds were compared to purine antimetabolites. At 24 months, 61% (103/170) of mesalamine participants relapsed compared to 67% (119/177) of azathioprine participants (RR 0.90, 95% CI 0.76 to 1.07; I² = 28%; low certainty evidence). During 24 months, 50% (9/18) of 5-ASA participants had clinical relapse compared to 13% (2/16) of adalimumab participants (RR 4.0, 95% CI 1.01 to 15.84; low certainty evidence). The effects of sulphasalazine compared to placebo on clinical relapse rate is uncertain. After 18 to 36 months, 66% (95/143) of participants treated with sulphasalazine relapsed compared to 71% (110/155) in the placebo group (RR 0.88, 95% CI 0.56 to 1.38; I² = 38%; low certainty evidence).The effect of 5-ASA drugs on safety was uncertain. During 24 months follow-up, 4% (2/55) of 5-ASA participants experienced adverse events compared to none (0/55) in the no treatment control group (RR 5.00, 95% CI 0.25 to 101.81; very low certainty evidence). An equal proportion of 5-ASA participants (10%; 23/241) and placebo (9%; 20/225) groups experienced an adverse event during a follow-up of 3 to 72 months (RR 1.07, 95% CI 0.60 to 1.91; I² = 0%; low certainty evidence). Adverse event rates were similar in the 5-ASA and purine analogues groups. However, serious adverse events and withdrawals due to adverse events were more common in participants who received purine analogues than 5-ASA. At 52 weeks to 24 months, 52% (107/207) of 5-ASA participants had an adverse event compared to 47% (102/218) of purine analogue participants (RR 1.11, 95% CI 0.97 to 1.27, I² = 0%; low certainty evidence). Four per cent (6/152) of 5-ASA participants had a serious adverse event compared to 17% (27/159) of purine analogue participants (RR 0.30, 95% CI 0.11 to 0.80; very low certainty evidence). Eight per cent (17/207) of 5-ASA participants withdrew due to an adverse event compared to 19% (42/218) of purine analogue participants (RR 0.48, 95% CI 0.28 to 0.83; low certainty evidence). Adverse event rates were similar in high and low dose mesalamine participants. After 12 months, 2% (2/101) of 4 g/day mesalamine participants had an adverse event compared to 2% (2/105) of 2.4 g/day participants (RR 1.04, 95% CI 0.15 to 7.24; low certainty evidence). The proportion of participants who experienced adverse events over a 24 month follow-up in the mesalamine group was 78% (14/18) compared to 69% (11/16) of adalimumab participants (RR 1.13, 95% CI 0.75 to 1.71; very low certainty evidence). None (0/32) of the sulphasalazine participants had an adverse event at 18 months follow-up compared to 3% (1/34) of the placebo group (RR 0.35, 95% CI 0.01 to 8.38; very low certainty evidence). Commonly reported adverse events in the included studies were diarrhoea, nausea, increased liver function tests, pancreatitis, and abdominal pain.
AUTHORS' CONCLUSIONS


5-ASA preparations are superior to placebo for the maintenance of surgically-induced clinical remission in patients with CD (moderate certainty). The number needed to treat to prevent one relapse was 13 patients. The evidence for endoscopic remission is uncertain. The sulphasalazine class of 5-ASA agents failed to demonstrate superiority against placebo, 5-ASAs failed to demonstrate superiority compared to no treatment (very low and low certainty). The efficacy of two different doses of the same 5-ASA and the efficacy of 5-ASA compared to purine antimetabolites (azathioprine or 6-mercaptopurine) in maintaining surgically-induced remission of CD remains unclear. However, purine analogues lead to more serious adverse events and discontinuation due to adverse events. There is a low certainty that 5-ASA is inferior for maintaining surgically-induced remission of CD compared to biologics (anti TNF-ɑ). 5-ASA formulations appear to be safe with no difference in the occurrence of adverse events or withdrawal when compared with placebo, no treatment or biologics.",2019,"5-ASA formulations appear to be safe with no difference in the occurrence of adverse events or withdrawal when compared with placebo, no treatment or biologics.","[""Crohn's disease"", 'patients with CD (moderate certainty', 'Fourteen RCTs (1867 participants) were included in the review', ""Crohn's disease (CD"", 'Participants (15 to 70 years) were recruited from gastroenterology hospitals and medical clinics in Europe and North America and followed up between 3 and 72 months', 'participants with CD in remission following surgery and compared 5-ASAs to no treatment']","['sulphasalazine', 'placebo', '5-ASA formulations', 'purine antimetabolites (azathioprine or 6-mercaptopurine', 'adalimumab', 'Oral 5-aminosalicylic acid', '5-ASA', 'mesalamine', 'azathioprine']","['serious adverse event', 'adverse event', 'diarrhoea, nausea, increased liver function tests, pancreatitis, and abdominal pain', 'adverse events', 'clinical relapse', 'Adverse event rates', 'endoscopic recurrence, radiologic and surgical relapse, adverse events, serious adverse events and withdrawal due to adverse events', 'clinical relapse rate', 'clinical relapse rates', 'efficacy and safety']","[{'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0439543', 'cui_str': 'Certainties (qualifier value)'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0017163', 'cui_str': 'Gastroenterology'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0338037', 'cui_str': ""Private physicians' group office (environment)""}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0036078', 'cui_str': 'Sulfasalazine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0127615', 'cui_str': 'mesalazine'}, {'cui': 'C0220903', 'cui_str': 'purine'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0000618', 'cui_str': 'mercaptopurine'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0232743', 'cui_str': 'Increased liver function (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205483', 'cui_str': 'Radiologic (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.529653,"5-ASA formulations appear to be safe with no difference in the occurrence of adverse events or withdrawal when compared with placebo, no treatment or biologics.","[{'ForeName': 'Teuta', 'Initials': 'T', 'LastName': 'Gjuladin-Hellon', 'Affiliation': 'School of Medicine, University of Central Lancashire, Preston, Lancashire, UK, PR1 7BH.'}, {'ForeName': 'Morris', 'Initials': 'M', 'LastName': 'Gordon', 'Affiliation': ''}, {'ForeName': 'Zipporah', 'Initials': 'Z', 'LastName': 'Iheozor-Ejiofor', 'Affiliation': ''}, {'ForeName': 'Anthony K', 'Initials': 'AK', 'LastName': 'Akobeng', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD008414.pub3']
1164,31256096,The efficacy of a modified Dix-Hallpike test with a pillow under shoulders.,"BACKGROUND


Dix-Hallpike (DH) test is sometimes done in a modified or reduced manner in a clinical setting. However, there has been no study that evaluated the reliability of this modified test.
OBJECTIVES


The purposes of this study were to determine whether the efficacy of a modified DH test, named the 'pillow under shoulders' test, was equivalent to the standard DH test and to assess the difference in patient discomfort between the two methods.
METHODS


Randomized controlled study at three academic referral hospitals, conducted in compliance with the CONSORT statement. Patients suspected for BPPV based on symptoms were randomly assigned to Group A or Group B. Patients in Group A received a standard DH test initially, followed by a modified DH test with a pillow under shoulders. Patients in Group B also received the two tests, but in the reverse order. The diagnostic results of both tests and patients' subjective scoring for uneasiness (discomfort, pain, anxiety) were statistically analyzed.
RESULTS


McNemar's test and Kappa statistics showed a statistically equivalent diagnostic value between standard and modified DH tests (Cohen's kappa = 0.823 and McNemar P = 0.18). The modified DH test had high sensitivity (95.5%) and fairly good specificity (87.9%). There was no statistical significance in the patients' subjective scoring for uneasiness between the two methods, although most patients reported less inconvenience after the modified DH test compared to the standard DH test.
CONCLUSIONS


The modified version of the standard DH test, the 'pillow under shoulders' method, may be a reliable, comfortable option to diagnose vertical canal BPPV. We suggest that this method can be used when head hanging is not feasible or sufficient for the standard DH test.",2019,"There was no statistical significance in the patients' subjective scoring for uneasiness between the two methods, although most patients reported less inconvenience after the modified DH test compared to the standard DH test.
","['Patients suspected for BPPV based on symptoms', 'Randomized controlled study at three academic referral hospitals, conducted in compliance with the CONSORT statement']","['modified Dix-Hallpike test', 'standard DH test initially, followed by a modified DH test with a pillow under shoulders']","['subjective scoring for uneasiness (discomfort, pain, anxiety', 'patient discomfort']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0155502', 'cui_str': 'Vertigo, Benign Recurrent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0182291', 'cui_str': 'Pillow, device (physical object)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",,0.0408816,"There was no statistical significance in the patients' subjective scoring for uneasiness between the two methods, although most patients reported less inconvenience after the modified DH test compared to the standard DH test.
","[{'ForeName': 'Eun-Ju', 'Initials': 'EJ', 'LastName': 'Jeon', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Dong-Hee', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Jung Mee', 'Initials': 'JM', 'LastName': 'Park', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Jeong-Hoon', 'Initials': 'JH', 'LastName': 'Oh', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Jae-Hyun', 'Initials': 'JH', 'LastName': 'Seo', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}]",Journal of vestibular research : equilibrium & orientation,['10.3233/VES-190666']
1165,31401207,The Effect of Steroids in Patients Undergoing Cardiopulmonary Bypass: An Individual Patient Meta-Analysis of Two Randomized Trials.,"OBJECTIVE


Steroids suppress the inflammatory response to cardiopulmonary bypass, but the impact on death at 30 days, myocardial infarction or injury, stroke, renal failure, respiratory failure, new atrial fibrillation, transfusion requirement, infection, and length of intensive care unit (ICU) and hospital stays are uncertain.
DESIGN


Patient-level data meta-analysis of 2 randomized trials.
SETTING


Eighty-eight cardiac surgical centers in 19 countries.
PARTICIPANTS


A total of 11,989 participants, from the Steroids in Cardiac Surgery trial and the Dexamethasone in Cardiac Surgery study, undergoing cardiac surgery with the use of cardiopulmonary bypass.
INTERVENTIONS


Participants were randomly assigned to steroid or placebo.
MEASURES AND MAIN RESULTS


Outcomes assessed were mortality at 30 days, myocardial infarction or injury, stroke, renal failure, respiratory failure, new atrial fibrillation, transfusion requirement, infection, and length of ICU and hospital stays. There was no significant difference in death at 30 days between the steroid and placebo groups (odds ratio [OR], 0.87; 95% confidence interval [CI], 0.72-1.07). Myocardial infarction did not differ significantly (OR, 1.17; 95% CI, 0.93-1.47); however, myocardial injury was higher in the steroid group (OR, 1.25; 95% CI, 1.12-1.40). There were no significant differences for the outcomes of stroke, renal failure, new atrial fibrillation, or transfusion. Steroids significantly reduced respiratory failure (OR, 0.83; 95% CI, 0.75-0.99), infection (OR, 0.80; 95% CI, 0.72-0.89), and length of ICU (p < 0.001) and hospital stays (p = 0.006).
CONCLUSIONS


This patient-level meta-analysis does not support the routine use of steroids in cardiac surgery. Steroid administration did not decrease the risk of death, myocardial infarction, stroke, renal failure, new atrial fibrillation, or transfusion. Steroids increased the risk of myocardial injury in both the Steroids in Cardiac Surgery and Dexamethasone in Cardiac Surgery trials. Finally, steroids lowered the risk of respiratory failure and infection, and reduced length of ICU and hospital stay.",2020,"Steroids significantly reduced respiratory failure (OR, 0.83; 95% CI, 0.75-0.99), infection (OR, 0.80; 95% CI, 0.72-0.89), and length of ICU (p < 0.001) and hospital stays (p = 0.006).
","['A total of 11,989 participants, from the Steroids in Cardiac Surgery trial and the Dexamethasone in Cardiac Surgery study, undergoing cardiac surgery with the use of cardiopulmonary bypass', 'Patients Undergoing Cardiopulmonary Bypass', 'Eighty-eight cardiac surgical centers in 19 countries']","['steroid or placebo', 'Steroids', 'placebo', 'Dexamethasone']","['length of ICU', 'risk of respiratory failure and infection, and reduced length of ICU and hospital stay', 'risk of myocardial injury', 'mortality at 30 days, myocardial infarction or injury, stroke, renal failure, respiratory failure, new atrial fibrillation, transfusion requirement, infection, and length of ICU and hospital stays', 'Myocardial infarction', 'risk of death, myocardial infarction, stroke, renal failure, new atrial fibrillation, or transfusion', 'myocardial injury', 'death', 'respiratory failure', 'stroke, renal failure, new atrial fibrillation, or transfusion', 'myocardial infarction or injury, stroke, renal failure, respiratory failure, new atrial fibrillation, transfusion requirement, infection, and length of intensive care unit (ICU) and hospital stays', 'hospital stays']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3889105', 'cui_str': 'Respiratory failure (SMQ)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.473704,"Steroids significantly reduced respiratory failure (OR, 0.83; 95% CI, 0.75-0.99), infection (OR, 0.80; 95% CI, 0.72-0.89), and length of ICU (p < 0.001) and hospital stays (p = 0.006).
","[{'ForeName': 'Richard P', 'Initials': 'RP', 'LastName': 'Whitlock', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, Ontario, Canada; Department of Surgery, McMaster University, Hamilton, Ontario, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada. Electronic address: richard.whitlock@phri.ca.'}, {'ForeName': 'Jan M', 'Initials': 'JM', 'LastName': 'Dieleman', 'Affiliation': 'University Medical Center, Utrecht, Netherlands.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Belley-Cote', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Vincent', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Devereaux', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, Ontario, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Cor J', 'Initials': 'CJ', 'LastName': 'Kalkman', 'Affiliation': 'University Medical Center, Utrecht, Netherlands.'}, {'ForeName': 'Diederik', 'Initials': 'D', 'LastName': 'van Dijk', 'Affiliation': 'University Medical Center, Utrecht, Netherlands.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2019.06.012']
1166,30362878,Kinematic and Neuromuscular Adaptations in Incomplete Spinal Cord Injury after High- versus Low-Intensity Locomotor Training.,"Recent data demonstrate improved locomotion with high-intensity locomotor training (LT) in individuals with incomplete spinal cord injury (iSCI), although concerns remain regarding reinforcement of abnormal motor strategies. The present study evaluated the effects of LT intensity on kinematic and neuromuscular coordination in individuals with iSCI. Using a randomized, crossover design, participants with iSCI received up to 20 sessions of high-intensity LT, with attempts to achieve 70-85% of age-predicted maximum heart rate (HRmax), or low-intensity LT (50-65% HRmax), following which the other intervention was performed. Specific measures included spatiotemporal variables, sagittal-plane gait kinematics, and neuromuscular synergies from electromyographic (EMG) recordings. Correlation analyses were conducted to evaluate associations between variables. Significant improvements in sagittal-plane joint excursions and intralimb hip-knee coordination were observed following high- but not low-intensity LT when comparing peak treadmill (TM) speed before and after LT. Neuromuscular complexity (i.e., number of synergies to explain >90% of EMG variance) was also increased following high- but not low-intensity LT. Comparison of speed-matched trials confirmed significant improvements in the knee excursion of the less impaired limb and intralimb hip-knee coordination, as well as improvements in neuromuscular complexity following high-intensity LT. These findings suggest greater neuromuscular complexity may be due to LT and not necessarily differences in speeds. Only selected kinematic changes (i.e., weak hip excursion) was correlated to improvements in treadmill speed. In conclusion, LT intensity can facilitate gains in kinematic variables and neuromuscular synergies in individuals with iSCI.",2019,"Comparison of speed-matched trials confirmed significant improvements in the knee excursion of the less impaired limb and intralimb hip-knee coordination, as well as improvements in neuromuscular complexity following high-intensity LT.","['individuals with incomplete spinal cord injury (iSCI', 'individuals with iSCI', 'participants with iSCI']","['intensity locomotor training (LT', 'High- versus Low-Intensity Locomotor Training']","['treadmill speed', 'neuromuscular complexity', 'sagittal-plane joint excursions and intralimb hip-knee coordination', 'spatiotemporal variables, sagittal-plane gait kinematics, and neuromuscular synergies from electromyographic (EMG) recordings', 'Neuromuscular complexity']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury (disorder)'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0419113', 'cui_str': 'Locomotor training (regime/therapy)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0935598', 'cui_str': 'Sagittal plane'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}]",,0.058473,"Comparison of speed-matched trials confirmed significant improvements in the knee excursion of the less impaired limb and intralimb hip-knee coordination, as well as improvements in neuromuscular complexity following high-intensity LT.","[{'ForeName': 'Marzieh M', 'Initials': 'MM', 'LastName': 'Ardestani', 'Affiliation': '1 Department of Physical Medicine and Rehabilitation, School of Medicine, Indiana University, Indianapolis, Indiana.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Henderson', 'Affiliation': '1 Department of Physical Medicine and Rehabilitation, School of Medicine, Indiana University, Indianapolis, Indiana.'}, {'ForeName': 'Seyed H', 'Initials': 'SH', 'LastName': 'Salehi', 'Affiliation': '1 Department of Physical Medicine and Rehabilitation, School of Medicine, Indiana University, Indianapolis, Indiana.'}, {'ForeName': 'Gordhan B', 'Initials': 'GB', 'LastName': 'Mahtani', 'Affiliation': '1 Department of Physical Medicine and Rehabilitation, School of Medicine, Indiana University, Indianapolis, Indiana.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Schmit', 'Affiliation': '2 Department of Physical Medicine and Rehabilitation, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'T George', 'Initials': 'TG', 'LastName': 'Hornby', 'Affiliation': '1 Department of Physical Medicine and Rehabilitation, School of Medicine, Indiana University, Indianapolis, Indiana.'}]",Journal of neurotrauma,['10.1089/neu.2018.5900']
1167,31201734,Acetyl-L-carnitine for the treatment of diabetic peripheral neuropathy.,"BACKGROUND


Diabetic peripheral neuropathy (DPN) is a common and severe complication that affects 50% of people with diabetes. Painful DPN is reported to occur in 16% to 24% of people with diabetes. A complete and comprehensive management strategy for the prevention and treatment of DPN, whether painful or not, has not yet been defined.Research into treatment for DPN has been characterised by a series of failed clinical trials, with few noteworthy advances. Strategies that support peripheral nerve regeneration and restore neurological function in people with painful or painless DPN are needed. The amino acid acetyl-L-carnitine (ALC) plays a role in the transfer of long-chain fatty acids into mitochondria for β-oxidation. ALC supplementation also induces neuroprotective and neurotrophic effects in the peripheral nervous system. Therefore, ALC supplementation targets several mechanisms relevant to potential nerve repair and regeneration, and could have clinical therapeutic potential. There is a need for a systematic review of the evidence from clinical trials.
OBJECTIVES


To assess the effects of ALC for the treatment of DPN.
SEARCH METHODS


On 2 July 2018, we searched the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, Embase, LILACS, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform. We checked references, searched citations, and contacted study authors to identify additional studies.
SELECTION CRITERIA


We included randomised controlled trials (RCTs) and quasi-RCTs of ALC compared with placebo, other therapy, or no intervention in the treatment of DPN. Participants could be of any sex and age, and have type 1 or type 2 diabetes mellitus, of any severity, with painful or painless DPN. We accepted any definition of minimum criteria for DPN, in accordance with the Toronto Consensus. We imposed no language restriction.Pain was the primary outcome, measured as the proportion of participants with at least 30% (moderate) or 50% (substantial) decrease in pain over baseline, or as the score on a visual analogue scale (VAS) or Likert scale for pain.
DATA COLLECTION AND ANALYSIS


We followed standard Cochrane methods.
MAIN RESULTS


We included four studies with 907 participants, which were reported in three publications. Three trials studied ALC versus placebo (675 participants); in one trial the dose of ALC was 2000 mg/day, and in the other two trials, it was 1500 mg/day or 3000 mg/day. The fourth trial studied ALC 1500 mg/day versus methylcobalamin 1.5 mg/day (232 participants). The risk of bias was high in both trials of different ALC doses and low in the other two trials.No included trial measured the proportion of participants with at least moderate (30%) or substantial (50%) pain relief. ALC reduced pain more than placebo, measured on a 0- to 100-mm VAS (MD -9.16, 95% CI -16.76 to -1.57; three studies; 540 participants; P = 0.02; I² = 56%; random-effects; very low-certainty evidence; a higher score indicating more pain). At doses of 1500 mg/day or less, the VAS score after ALC treatment was little different from placebo (MD -0.05, 95% CI -10.00 to 9.89; two studies; 159 participants; P = 0.99; I² = 0%), but at doses greater than 1500 mg/day, ALC reduced pain more than placebo (MD -14.93, 95% CI -19.16 to -10.70; three studies; 381 participants; P < 0.00001; I² = 0%). This subgroup analysis should be viewed with caution as the evidence was even less certain than the overall analysis, which was already of very low certainty.Two placebo-controlled studies reported that vibration perception improved after 12 months. We graded this evidence as very low certainty, due to inconsistency and a high risk of bias, as the trial authors did not provide any numerical data. The placebo-controlled studies did not measure functional impairment and disability scores. No study used validated symptom scales. One study performed sensory testing, but the evidence was very uncertain.The fourth included study compared ALC with methylcobalamin, but did not report effects on pain. There was a reduction from baseline to 24 weeks in functional impairment and disability, based on the change in mean Neuropathy Disability Score (NDS; scale from zero to 10), but there was no important difference between the ALC group (mean score 1.66 ± 1.90) and the methylcobalamin group (mean score 1.35 ± 1.65) groups (P = 0.23; low-certainty evidence).One placebo-controlled study reported that six of 147 participants in the ALC > 1500 mg/day group (4.1%) and two of 147 participants in the placebo group (1.4%) discontinued treatment because of adverse events (headache, facial paraesthesia, and gastrointestinal disorders) (P = 0.17). The other two placebo-controlled studies reported no dropouts due to adverse events, and more pain, paraesthesia, and hyperaesthesias in the placebo group than the 3000 mg/day ALC group, but provided no numerical data. The overall certainty of adverse event evidence for the comparison of ALC versus placebo was low.The study comparing ALC with methylcobalamin reported that 34/117 participants (29.1%) experienced adverse events in the ALC group versus 33/115 (28.7%) in the methylcobalamin group (P = 0.95). Nine participants discontinued treatment due to adverse events (ALC: 4 participants, methylcobalamin: 5 participants), which were most commonly gastrointestinal symptoms. The certainty of the adverse event evidence for ALC versus methylcobalamin was low.Two studies were funded by the manufacturer of ALC and the other two studies had at least one co-author who was a consultant for an ALC manufacturer.
AUTHORS' CONCLUSIONS


We are very uncertain whether ALC causes a reduction in pain after 6 to 12 months' treatment in people with DPN, when compared with placebo, as the evidence is sparse and of low certainty. Data on functional and sensory impairment and symptoms are lacking, or of very low certainty. The evidence on adverse events is too uncertain to make any judgements on safety.",2019,"ALC reduced pain more than placebo, measured on a 0- to 100-mm VAS (MD -9.16, 95% CI -16.76 to -1.57; three studies; 540 participants; P = 0.02; I² = 56%; random-effects; very low-certainty evidence; a higher score indicating more pain).","['people with painful or painless DPN', 'people with diabetes', 'diabetic peripheral neuropathy', 'Participants could be of any sex and age, and have type 1 or type 2 diabetes mellitus, of any severity, with painful or painless DPN', '907 participants, which were reported in three publications']","['placebo', 'ALC', 'ALC supplementation', 'Acetyl-L-carnitine', 'methylcobalamin']","['neuroprotective and neurotrophic effects', 'visual analogue scale (VAS) or Likert scale for pain', 'pain', 'Pain', 'vibration perception', 'pain, paraesthesia, and hyperaesthesias', 'VAS score', 'adverse events', 'mean Neuropathy Disability Score (NDS; scale', 'ALC reduced pain', 'functional impairment and disability scores', 'adverse events (headache, facial paraesthesia, and gastrointestinal disorders', 'pain relief']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234226', 'cui_str': 'Painless (qualifier value)'}, {'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C0740447', 'cui_str': 'Peripheral neuropathy co-occurrent and due to diabetes mellitus'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0034036', 'cui_str': 'Publications'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001040', 'cui_str': 'Acetylcarnitine'}, {'cui': 'C0065844', 'cui_str': 'methylcobalamin'}]","[{'cui': 'C4704801', 'cui_str': 'Neurotrophic'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0057753', 'cui_str': 'NDS'}, {'cui': 'C0222045'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0239517', 'cui_str': 'Facial paresthesia (finding)'}, {'cui': 'C0017178', 'cui_str': 'Gastrointestinal Diseases'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}]",,0.621303,"ALC reduced pain more than placebo, measured on a 0- to 100-mm VAS (MD -9.16, 95% CI -16.76 to -1.57; three studies; 540 participants; P = 0.02; I² = 56%; random-effects; very low-certainty evidence; a higher score indicating more pain).","[{'ForeName': 'Luiz Csp', 'Initials': 'LC', 'LastName': 'Rolim', 'Affiliation': 'Department of Internal Medicine, Universidade Federal de São Paulo, Rua Borges Lagoa, 1065/110, São Paulo, São Paulo, Brazil, 04038-032.'}, {'ForeName': 'Edina Mk', 'Initials': 'EM', 'LastName': 'da Silva', 'Affiliation': ''}, {'ForeName': 'Ronald Lg', 'Initials': 'RL', 'LastName': 'Flumignan', 'Affiliation': ''}, {'ForeName': 'Marcio M', 'Initials': 'MM', 'LastName': 'Abreu', 'Affiliation': ''}, {'ForeName': 'Sérgio A', 'Initials': 'SA', 'LastName': 'Dib', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD011265.pub2']
1168,31233604,"Improving the Knowledge, Attitudes, and Behavioral Intentions of Perinatal Care Providers Toward Childbearing Individuals Identifying as LGBTQ: A Quasi-Experimental Study.","BACKGROUND


This study explores the impact of gender and sexuality awareness training on perinatal health care providers' (HCPs') knowledge, attitudes, and intended behavior toward childbearing individuals identifying as lesbian, gay, bisexual, transgender, and/or queer (LGBTQ).
METHOD


A nonrandom convenience sample of HCPs (n = 187) comprised an experimental group (n = 99) who attended grand rounds trainings covering gender and sexuality topics and a control group (n = 88) who attended sessions on other unrelated topics. All participants completed a pre-posttraining questionnaire to assess changes in knowledge, attitudes, and intended behavior toward LGBTQ patients.
RESULTS


Participants in the experimental group demonstrated significant improvement in knowledge, misconception, prejudice, sensitive language, and normativity regarding LGBTQ pregnant patients from pretest to posttest.
CONCLUSION


These findings suggest that a 40-minute gender and sexuality training can immediately improve HCPs' knowledge, attitudes, and intended behavior toward LGBTQ childbearing patients. [J Contin Educ Nurs. 2019;50(7):303-312.].",2019,"RESULTS


Participants in the experimental group demonstrated significant improvement in knowledge, misconception, prejudice, sensitive language, and normativity regarding LGBTQ pregnant patients from pretest to posttest.
","['Childbearing Individuals Identifying as LGBTQ', 'A nonrandom convenience sample of HCPs (n = 187) comprised an experimental group (n = 99) who attended grand rounds trainings covering gender and sexuality topics and a control group (n = 88) who attended sessions on other unrelated topics']",['sexuality awareness training'],"['knowledge, misconception, prejudice, sensitive language, and normativity', 'Knowledge, Attitudes, and Behavioral Intentions']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C2717796', 'cui_str': 'Grand Rounds'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0036915', 'cui_str': 'Sexuality'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445356', 'cui_str': 'Unrelated (finding)'}]","[{'cui': 'C0036915', 'cui_str': 'Sexuality'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0033023', 'cui_str': 'Prejudice'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",187.0,0.0180156,"RESULTS


Participants in the experimental group demonstrated significant improvement in knowledge, misconception, prejudice, sensitive language, and normativity regarding LGBTQ pregnant patients from pretest to posttest.
","[{'ForeName': 'Randi Beth', 'Initials': 'RB', 'LastName': 'Singer', 'Affiliation': ''}, {'ForeName': 'Betsy', 'Initials': 'B', 'LastName': 'Crane', 'Affiliation': ''}, {'ForeName': 'Edward P', 'Initials': 'EP', 'LastName': 'Lemay', 'Affiliation': ''}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Omary', 'Affiliation': ''}]",Journal of continuing education in nursing,['10.3928/00220124-20190612-05']
1169,31233079,Twenty-Four Months' Resistance and Endurance Training Improves Muscle Size and Physical Functions but Not Muscle Quality in Older Adults Requiring Long-Term Care.,"OBJECTIVES


To assess the effects of 24 months training on muscle quality, size, strength, and gait abilities in older adults who need long-term care.
DESIGN


Non-randomized controlled trial Setting: Kawai Rehabilitation Center and Kajinoki Medical Clinic.
PARTICIPANTS


Ten older participants who needed long-term care (age, 76.7 ± 5.6 years) were participated as training group (Tr-group) and 10 older men and women who did not require long-term care (age, 72.9 ± 6.6 years) comprised the control group (Cont-group).
INTERVENTION


Tr-group performed resistive and endurance exercises once or twice a week for 24 months.
MEASUREMENTS


Using ultrasound images, echo intensity (EI) and muscle thickness were measured in the rectus femoris and biceps femoris as an index of muscle quality and size. Physical performance was measured before and after the training; performance parameters included knee extension peak torque, 5-m normal and maximal walk test, sit-to-stand and timed up and go test.
RESULTS


After the training, there was no change in EI, while BF thickness was increased (pre; 1.82 ± 0.29 cm, 24 months; 2.14 ± 0.23 cm, p < 0.05) in Tr-group. Walk-related performances were improved after the training in Tr-group (i.e. 5-m walk test and timed up and go test). The percent change of knee extension peak torque explained the percent change of EI in the rectus femoris (regression coefficient = 1.24, R = 0.91, adjusted R2 = 0.82, p < 0.001).
CONCLUSIONS


Twenty-four months' training induced muscle hypertrophy and improved physical functions. Increased muscle quality in the rectus femoris could be a key to improved knee extension peak torque, with the potential to eventually reduce the need for long-term care in older individuals.",2019,Walk-related performances were improved after the training in Tr-group (i.e. 5-m walk test and timed up and go test).,"['Ten older participants who needed long-term care (age, 76.7 ± 5.6 years) were participated as training group (Tr-group) and 10 older men and women who did not require long-term care (age, 72.9 ± 6.6 years', 'Older Adults Requiring Long-Term Care', 'older adults who need long-term care']","['Endurance Training', 'Tr-group performed resistive and endurance exercises', 'control group (Cont-group']","['change in EI, while BF thickness', 'Muscle Size and Physical Functions', 'Physical performance', 'muscle hypertrophy and improved physical functions', 'knee extension peak torque', 'muscle quality', 'knee extension peak torque, 5-m normal and maximal walk test, sit-to-stand and timed up and go test', 'muscle quality, size, strength, and gait abilities', 'Using ultrasound images, echo intensity (EI) and muscle thickness', 'rectus femoris and biceps femoris as an index of muscle quality and size']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0023977'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517794', 'cui_str': '5.6 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C4517823', 'cui_str': '6.6 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise (regime/therapy)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C2607857'}, {'cui': 'C0236033', 'cui_str': 'Muscle hypertrophy (finding)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0584894', 'cui_str': 'Rectus Femoris'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",10.0,0.0197952,Walk-related performances were improved after the training in Tr-group (i.e. 5-m walk test and timed up and go test).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Yoshiko', 'Affiliation': 'Akito Yoshiko, Ph.D. School of International Liberal Studies, Chukyo University, 101 Tokodachi, Kaizu, Toyota, Aichi 470-0393, Japan, Tel: +81 (565) 46-6952, E-mail: yoshiko@lets.chukyo-u.ac.jp.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Kaji', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Sugiyama', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Koike', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Oshida', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Akima', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-019-1208-8']
1170,31794324,"Valproate and Retinoic Acid in Combination With Decitabine in Elderly Nonfit Patients With Acute Myeloid Leukemia: Results of a Multicenter, Randomized, 2 × 2, Phase II Trial.","PURPOSE


DNA-hypomethylating agents are studied in combination with other epigenetic drugs, such as histone deacetylase inhibitors or differentiation inducers (eg, retinoids), in myeloid neoplasias. A randomized, phase II trial with a 2 × 2 factorial design was conducted to investigate the effects of the histone deacetylase inhibitor valproate and all- trans  retinoic acid (ATRA) in treatment-naive elderly patients with acute myeloid leukemia (AML).
PATIENTS AND METHODS


Two hundred patients (median age, 76 years; range, 61-92 years) ineligible for induction chemotherapy received decitabine (20 mg/m 2  intravenously, days 1 to 5) alone (n = 47) or in combination with valproate (n = 57), ATRA (n = 46), or valproate + ATRA (n = 50). The primary endpoint was objective response, defined as complete and partial remission, tested at a one-sided significance level of α = .10. Key secondary endpoints were overall survival, event-free survival, and progression-free survival and safety.
RESULTS


The addition of ATRA resulted in a higher remission rate (21.9% with ATRA  v  13.5% without ATRA; odds ratio, 1.80; 95% CI, 0.86 to 3.79; one-sided  P  = .06). For valproate, no effect was observed (17.8% with valproate  v  17.2% without valproate; odds ratio, 1.06; 95% CI, 0.51 to 2.21; one-sided  P  = .44). Median overall survival was 8.2 months with ATRA  v  5.1 months without ATRA (hazard ratio, 0.65; 95% CI, 0.48 to 0.89; two-sided  P  = .006). Improved survival was observed across risk groups, including patients with adverse cytogenetics, and was associated with longer response duration. With valproate, no survival difference was observed. Toxicities were predominantly hematologic, without relevant differences between the 4 arms.
CONCLUSION


The addition of ATRA to decitabine resulted in a higher remission rate and a clinically meaningful survival extension in these patients with difficult-to-treat disease, without added toxicity.",2020,"The addition of ATRA resulted in a higher remission rate (21.9% with ATRA  v  13.5% without ATRA; odds ratio, 1.80; 95% CI, 0.86 to 3.79; one-sided  P  = .06).","['Elderly Nonfit Patients With Acute Myeloid Leukemia', 'treatment-naive elderly patients with acute myeloid leukemia (AML', 'Two hundred patients (median age, 76 years; range, 61-92 years) ineligible for']","['valproate + ATRA', 'ATRA', 'Valproate and Retinoic Acid', 'Decitabine', 'induction chemotherapy received decitabine (20 mg/m 2  intravenously, days 1 to 5) alone (n = 47) or in combination with valproate', 'valproate', 'histone deacetylase inhibitor valproate and all- trans  retinoic acid (ATRA']","['objective response, defined as complete and partial remission, tested at a one-sided significance level of α ', 'Toxicities', 'remission rate', 'Median overall survival', 'Improved survival', 'survival difference', 'overall survival, event-free survival, and progression-free survival and safety']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C0040845', 'cui_str': 'retinoic acid'}, {'cui': 'C0049065', 'cui_str': 'decitabine'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1512474', 'cui_str': 'HDAC Inhibitors'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",200.0,0.406788,"The addition of ATRA resulted in a higher remission rate (21.9% with ATRA  v  13.5% without ATRA; odds ratio, 1.80; 95% CI, 0.86 to 3.79; one-sided  P  = .06).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lübbert', 'Affiliation': 'Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Grishina', 'Affiliation': 'Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Schmoor', 'Affiliation': 'Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Schlenk', 'Affiliation': 'University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Jost', 'Affiliation': 'University Hospital Rheinisch-Westfälische Technische Hochschule Aachen University, Aachen, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Crysandt', 'Affiliation': 'University Hospital Rheinisch-Westfälische Technische Hochschule Aachen University, Aachen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Heuser', 'Affiliation': 'Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Felicitas', 'Initials': 'F', 'LastName': 'Thol', 'Affiliation': 'Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Helmut R', 'Initials': 'HR', 'LastName': 'Salih', 'Affiliation': 'German Cancer Consortium (DKTK) and German Cancer Research Center (DKFZ), Tübingen, Germany.'}, {'ForeName': 'Marcus M', 'Initials': 'MM', 'LastName': 'Schittenhelm', 'Affiliation': 'Eberhard-Karls-University, Tübingen, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Germing', 'Affiliation': 'Faculty of Medicine, Heinrich-Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Kuendgen', 'Affiliation': 'Faculty of Medicine, Heinrich-Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Katharina S', 'Initials': 'KS', 'LastName': 'Götze', 'Affiliation': 'Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Hans-Walter', 'Initials': 'HW', 'LastName': 'Lindemann', 'Affiliation': 'Catholic Hospital, Hagen, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Müller-Tidow', 'Affiliation': 'Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Heil', 'Affiliation': 'Klinikum Lüdenscheid, Lüdenscheid, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Scholl', 'Affiliation': 'Universitätsklinikum Jena, Jena, Germany.'}, {'ForeName': 'Gesine', 'Initials': 'G', 'LastName': 'Bug', 'Affiliation': 'University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Schwaenen', 'Affiliation': 'Hospital Esslingen, Esslingen, Germany.'}, {'ForeName': 'Aristoteles', 'Initials': 'A', 'LastName': 'Giagounidis', 'Affiliation': 'Marien-Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Neubauer', 'Affiliation': 'University Clinic Gießen/Marburg, Marburg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Krauter', 'Affiliation': 'Städtisches Klinikum Braunschweig, Braunschweig, Germany.'}, {'ForeName': 'Wolfram', 'Initials': 'W', 'LastName': 'Brugger', 'Affiliation': 'Hospital Villingen-Schwenningen, Villingen-Schwenningen, Germany.'}, {'ForeName': 'Maike', 'Initials': 'M', 'LastName': 'De Wit', 'Affiliation': 'Vivantes Klinikum Neukoelln, Berlin, Germany.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Wäsch', 'Affiliation': 'Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Becker', 'Affiliation': 'Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Annette M', 'Initials': 'AM', 'LastName': 'May', 'Affiliation': 'Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Justus', 'Initials': 'J', 'LastName': 'Duyster', 'Affiliation': 'Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Konstanze', 'Initials': 'K', 'LastName': 'Döhner', 'Affiliation': 'University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Ganser', 'Affiliation': 'Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Hackanson', 'Affiliation': 'Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Döhner', 'Affiliation': 'University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01053']
1171,29933239,Time to epileptiform activity and EEG background recovery are independent predictors after cardiac arrest.,"OBJECTIVE


Investigate the temporal development of EEG and prognosis.
METHODS


Prospective observational substudy of the Target Temperature Management trial. Six sites performed simplified continuous EEG-monitoring (cEEG) on comatose patients after cardiac arrest, blinded to treating physicians. We determined time-points of recovery of a normal-voltage continuous background activity and the appearance of an epileptiform EEG, defined as abundant epileptiform discharges, periodic/rhythmic discharges or electrographic seizure activity.
RESULTS


134 patients were included, 65 had a good outcome. Early recovery of continuous background activity (within 24 h) occurred in 72 patients and predicted good outcome since 55 (76%) had good outcome, increasing the odds for a good outcome seven times compared to a late background recovery. Early appearance of an epileptiform EEG occurred in 38 patients and 34 (89%) had a poor outcome, increasing the odds for a poor outcome six times compared to a late debut. The time to background recovery and the time to epileptiform activity were highly associated with outcome and levels of neuron-specific enolase. Multiple regression analysis showed that both variables were independent predictors.
CONCLUSIONS


Time to epileptiform activity and background recovery are independent prognostic indicators.
SIGNIFICANCE


Patients with early background recovery combined with late appearance of epileptiform activity may have a good outcome.",2018,"Early appearance of an epileptiform EEG occurred in 38 patients and 34 (89%) had a poor outcome, increasing the odds for a poor outcome six times compared to a late debut.","['comatose patients after cardiac arrest, blinded to treating physicians', '134 patients were included, 65 had a good outcome']",['Six sites performed simplified continuous EEG-monitoring (cEEG'],"['time to background recovery and the time to epileptiform activity', 'Early appearance of an epileptiform EEG', 'Early recovery of continuous background activity']","[{'cui': 'C0009421', 'cui_str': 'Comatose'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}]","[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}]",134.0,0.0261281,"Early appearance of an epileptiform EEG occurred in 38 patients and 34 (89%) had a poor outcome, increasing the odds for a poor outcome six times compared to a late debut.","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Westhall', 'Affiliation': 'Lund University, Skane University Hospital, Department of Clinical Sciences, Clinical Neurophysiology, Lund, Sweden. Electronic address: erik.westhall@med.lu.se.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Rosén', 'Affiliation': 'Lund University, Skane University Hospital, Department of Clinical Sciences, Clinical Neurophysiology, Lund, Sweden. Electronic address: ingmar.rosen@skane.se.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rundgren', 'Affiliation': 'Lund University, Skane University Hospital, Department of Clinical Sciences, Anaesthesiology and Intensive Care, Lund, Sweden. Electronic address: malin.rundgren@skane.se.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bro-Jeppesen', 'Affiliation': 'Department of Cardiology, Rigshospitalet and Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark. Electronic address: jbj@dadlnet.dk.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kjaergaard', 'Affiliation': 'Department of Cardiology, Rigshospitalet and Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark. Electronic address: jesper.kjaergaard.05@regionh.dk.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hassager', 'Affiliation': 'Department of Cardiology, Rigshospitalet and Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark. Electronic address: hassager@dadlnet.dk.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Lindehammar', 'Affiliation': 'Clinical Neurophysiology, Department of Clinical and Experimental Medicine, Linköping University, Sweden. Electronic address: hans.lindehammar@regionostergotland.se.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Horn', 'Affiliation': 'Department of Intensive Care Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands. Electronic address: j.horn@amc.uva.nl.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ullén', 'Affiliation': 'Clinical Studies Sweden - Forum South, Skane University Hospital, Lund, Sweden. Electronic address: susann.ullen@skane.se.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Nielsen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Intensive Care Unit, Helsingborg Hospital, Helsingborg, Sweden. Electronic address: niklas.nielsen@med.lu.se.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Friberg', 'Affiliation': 'Lund University, Skane University Hospital, Department of Clinical Sciences, Anaesthesiology and Intensive Care, Lund, Sweden. Electronic address: hans.friberg@skane.se.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Cronberg', 'Affiliation': 'Lund University, Skane University Hospital, Department of Clinical Sciences, Neurology, Lund, Sweden. Electronic address: tobias.cronberg@skane.se.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2018.05.016']
1172,31538954,Accuracy of Parent-Reported Child Height and Weight and Calculated Body Mass Index Compared With Objectively Measured Anthropometrics: Secondary Analysis of a Randomized Controlled Trial.,"BACKGROUND


Electronic health (eHealth) interventions for children often rely on parent-reported child anthropometric measures. However, limited studies have assessed parental accuracy in reporting child height and weight via Web-based approaches.
OBJECTIVE


The objective of this study was to determine the accuracy of parent-reported child height and weight, as well as body mass index and weight category that we calculated from these data. We also aimed to explore whether parent report was influenced by age, sex, weight status, or exposure to participation in a 12-week brief Web-based family lifestyle intervention.
METHODS


This study was a secondary analysis of data from a 12-week childhood obesity pilot randomized controlled trial in families with children aged 4 to 11 years in Australia. We asked parents to report demographic information, including child height and weight, using an online survey before their child's height and weight were objectively measured by a trained research assistant at baseline and week 12. We analyzed data using the Lin concordance correlation coefficient (ρc, ranging from 0 [poor] to ±1 [perfect] concordance), Cohen kappa coefficient, and multivariable linear regression models.
RESULTS


There were 42 families at baseline and 35 families (83%) at week 12. Overall, the accuracy of parent-reported child height was moderate (ρc=.94), accuracy of weight was substantial (ρc=.96), and accuracy of calculated body mass index was poor (ρc=.63). Parents underreported child height and weight, respectively, by 0.9 cm and 0.5 kg at baseline and by 0.2 cm and 1.6 kg after participating in a 12-week brief Web-based family lifestyle intervention. The overall interrater agreement of child body mass index category was moderate at baseline (κ=.59) and week 12 (κ=.54). The weight category calculated from 74% (n=31) and 70% (n=23) of parent-reported child height and weight was accurate at baseline and week 12, respectively. Parental age was significantly (95% CI -0.52 to -0.06; P=.01) associated with accuracy of reporting child height. Child age was significantly (95% CI -2.34 to -0.06; P=.04) associated with reporting of child weight.
CONCLUSIONS


Most Australian parents were reasonably accurate in reporting child height and weight among a group of children aged 4 to 11 years. The weight category of most of the children when calculated from parent-reported data was in agreement with the objectively measured data despite the body mass index calculated from parent-reported data having poor concordance at both time points. Online parent-reported child height and weight may be a valid method of collecting child anthropometric data ahead of participation in a Web-based program. Future studies with larger sample sizes and repeated measures over time in the context of eHealth research are warranted. Future studies should consider modeling the impact of calibration equations applied to parent-reported anthropometric data on study outcomes.",2019,Parental age was significantly (95% CI -0.52 to -0.06; P=.01) associated with accuracy of reporting child height.,"['Parents underreported child height and weight, respectively, by 0.9 cm and 0.5 kg at baseline and by 0.2 cm and 1.6 kg after participating in a 12-week brief Web-based family lifestyle intervention', 'families with children aged 4 to 11 years in Australia']",['Electronic health (eHealth) interventions'],"['child height and weight', 'Child Height and Weight and Calculated Body Mass Index', 'accuracy of weight', 'accuracy of parent-reported child height', 'reporting of child weight']","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0424638', 'cui_str': 'Height and weight'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C4517508', 'cui_str': '1.6 (qualifier value)'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0424638', 'cui_str': 'Height and weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",42.0,0.0596458,Parental age was significantly (95% CI -0.52 to -0.06; P=.01) associated with accuracy of reporting child height.,"[{'ForeName': 'Li Kheng', 'Initials': 'LK', 'LastName': 'Chai', 'Affiliation': 'School of Health Sciences, Faculty of Health and Medicine, The University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Clare E', 'Initials': 'CE', 'LastName': 'Collins', 'Affiliation': 'School of Health Sciences, Faculty of Health and Medicine, The University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'May', 'Affiliation': 'School of Health Sciences, Faculty of Health and Medicine, The University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Holder', 'Affiliation': 'Hunter Medical Research Institute, New Lambton, Australia.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Burrows', 'Affiliation': 'School of Health Sciences, Faculty of Health and Medicine, The University of Newcastle, Callaghan, Australia.'}]",Journal of medical Internet research,['10.2196/12532']
1173,31240842,"A randomized, double-blind, placebo-controlled study of the kappa opioid receptor antagonist, CERC-501, in a human laboratory model of smoking behavior.","Preclinical data indicate that selective kappa opioid receptor antagonists reduce nicotine self-administration and withdrawal symptoms. The aim of the current study was to determine whether treatment with CERC-501, an orally available, potent, and selective kappa opioid receptor antagonist, could alleviate nicotine withdrawal and craving and mitigate mood alterations associated with nicotine withdrawal in humans. Healthy, adult cigarette smokers were enrolled into this randomized, multisite, double-blind, placebo-controlled, crossover study. Participants completed two 8-day treatment phases during which they received either CERC-501 (15 mg, p.o., once daily) or placebo. On the seventh day of each dosing phase, participants were admitted as inpatients for an 18-hour cigarette abstinence period followed by experimental testing. The primary outcome measures were (a) performance on the McKee Smoking Lapse test (ie, latency to smoke in exchange for money) and (b) number of cigarettes self-administered during a 60-minute ad lib smoking period. Other outcomes included measures of craving, mood, anxiety, nicotine withdrawal, and subjective effects of cigarette smoking. A total of 71 participants who smoked an average of approximately 23 cigarettes per day were enrolled, and 56 subjects completed the study. CERC-501 was well tolerated, but it did not significantly alter the latency to start smoking (CERC-501: 16.5 min vs placebo: 17.7 min) or the number of cigarettes smoked (CERC-501: 3.3 cigarettes vs placebo: 3.1 cigarettes). Compared with placebo, CERC-501 also did not affect cigarette craving, mood, anxiety, nicotine withdrawal, or subjective effects of smoking. These findings do not support a role for CERC-501 in the treatment of nicotine use disorder.",2020,"Compared with placebo, CERC-501 also did not affect cigarette craving, mood, anxiety, nicotine withdrawal, or subjective effects of smoking.","['humans', 'Healthy, adult cigarette smokers', 'participants were admitted as inpatients for an 18-hour cigarette abstinence period followed by experimental testing', '71 participants who smoked an average of approximately 23 cigarettes per day were enrolled, and 56 subjects completed the study']","['CERC-501', 'placebo', 'placebo, CERC-501', 'kappa opioid receptor antagonist, CERC-501']","['tolerated', 'a) performance on the McKee Smoking Lapse test (ie, latency to smoke in exchange for money) and (b) number of cigarettes self-administered during a 60-minute ad lib smoking period', 'latency to start smoking', 'cigarette craving, mood, anxiety, nicotine withdrawal, or subjective effects of smoking', 'craving, mood, anxiety, nicotine withdrawal, and subjective effects of cigarette smoking']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0761929', 'cui_str': 'kappa1 opioid receptors'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]","[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0028047', 'cui_str': 'Nicotine withdrawal (disorder)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0700219', 'cui_str': 'Cigarette Smoking'}]",71.0,0.22683,"Compared with placebo, CERC-501 also did not affect cigarette craving, mood, anxiety, nicotine withdrawal, or subjective effects of smoking.","[{'ForeName': 'Jermaine D', 'Initials': 'JD', 'LastName': 'Jones', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute and Columbia University Vagelos College of Physicians and Surgeons, New York City, New York, USA.'}, {'ForeName': 'Shanna', 'Initials': 'S', 'LastName': 'Babalonis', 'Affiliation': 'Department of Behavioral Science, Center on Drug and Alcohol Research, University of Kentucky, Lexington, Kentucky, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Marcus', 'Affiliation': 'Supernus Pharmaceuticals, Rockville, Maryland, USA.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Vince', 'Affiliation': 'Vince and Associates, Overland Park, Kansas, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Kelsh', 'Affiliation': 'Vince and Associates, Overland Park, Kansas, USA.'}, {'ForeName': 'Michelle R', 'Initials': 'MR', 'LastName': 'Lofwall', 'Affiliation': 'Department of Behavioral Science, Center on Drug and Alcohol Research, University of Kentucky, Lexington, Kentucky, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Fraser', 'Affiliation': 'Cerecor Inc, Baltimore, Maryland, USA.'}, {'ForeName': 'Blake', 'Initials': 'B', 'LastName': 'Paterson', 'Affiliation': 'NRZ Consulting, Baltimore, Maryland, USA.'}, {'ForeName': 'Suky', 'Initials': 'S', 'LastName': 'Martinez', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute and Columbia University Vagelos College of Physicians and Surgeons, New York City, New York, USA.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Martinez', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute and Columbia University Vagelos College of Physicians and Surgeons, New York City, New York, USA.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute and Columbia University Vagelos College of Physicians and Surgeons, New York City, New York, USA.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Walsh', 'Affiliation': 'Department of Behavioral Science, Center on Drug and Alcohol Research, University of Kentucky, Lexington, Kentucky, USA.'}, {'ForeName': 'Sandra D', 'Initials': 'SD', 'LastName': 'Comer', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute and Columbia University Vagelos College of Physicians and Surgeons, New York City, New York, USA.'}]",Addiction biology,['10.1111/adb.12799']
1174,30885809,"Evaluation of computer-based retinopathy of prematurity (ROP) education for ophthalmology residents: a randomized, controlled, multicenter study.","PURPOSE


To evaluate the effect of a computer-based training program-Massachusetts Eye & Ear ROP Trainer-on residents' knowledge of retinopathy of prematurity (ROP) management.
METHODS


In this prospective, randomized study, ophthalmology residents from nine different training programs consented to participate. Those who completed the study were randomly assigned to either the Trainer or the control group. The ROP Trainer was created using clinical cases encompassing the stages of ROP in digital pictures and videos. It includes sections on screening decisions, examination techniques, and diagnosis, and a reference section with the expert video clips and a searchable image library. Subjects in the control group were asked to study standard print material on ROP. A pre- and post-test, consisting of theoretical and practical (diagnosis) questions, and a post-intervention satisfaction test were administered. Accuracy of ROP diagnosis was assessed.
RESULTS


A total of 180 residents agreed to participate, of whom 60 completed the study. Residents in the Trainer group had statistically significant improvements (P = 0.003) in ROP knowledge and diagnostic ability (P = 0.005). Residents randomized to the Trainer group were more satisfied with the training materials than were those in the control group. There was no significant difference in improving knowledge by year of training, sex, or country. Considering all training levels, a statistically significant increase was observed in sensitivity for the diagnosis of preplus or worse, zone I or II, ROP stage, category, and aggressive posterior ROP in the Trainer group.
CONCLUSIONS


In this study, the Trainer was shown to significantly improve ROP knowledge and diagnostic skills of residents, regardless of sex, year, of training, or country.",2019,Residents in the Trainer group had statistically significant improvements (P = 0.003) in ROP knowledge and diagnostic ability (P = 0.005).,"['ophthalmology residents', 'ophthalmology residents from nine different training programs consented to participate', '180 residents agreed to participate, of whom 60 completed the study']","['computer-based retinopathy of prematurity (ROP) education', 'computer-based training program-Massachusetts Eye & Ear\xa0ROP Trainer', 'standard print material on ROP']","['sensitivity for the diagnosis of preplus or worse, zone I or II, ROP stage, category, and aggressive posterior ROP', 'ROP knowledge and diagnostic ability', 'Accuracy of ROP diagnosis', 'ROP knowledge and diagnostic skills', 'improving knowledge by year of training, sex, or country']","[{'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035344', 'cui_str': 'Retrolental Fibroplasia'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0013443', 'cui_str': 'Vestibulocochlear Apparatus'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034036', 'cui_str': 'Publications'}]","[{'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]",180.0,0.0187988,Residents in the Trainer group had statistically significant improvements (P = 0.003) in ROP knowledge and diagnostic ability (P = 0.005).,"[{'ForeName': 'Ramak', 'Initials': 'R', 'LastName': 'Roohipoor', 'Affiliation': 'Massachusetts Eye and Ear, Harvard Medical School, Department of Ophthalmology, Boston, Massachusetts; Farabi Eye Hospital, Eye Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Alvarez', 'Affiliation': 'Pontifical Catholic University, Santiago, Chile.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Brodowska', 'Affiliation': 'University Hospitals of Cleveland, Cleveland, Ohio.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Yaseri', 'Affiliation': 'Biostatistics Department, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Kloek', 'Affiliation': 'Massachusetts Eye and Ear, Harvard Medical School, Department of Ophthalmology, Boston, Massachusetts.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Riazi', 'Affiliation': 'Farabi Eye Hospital, Eye Research Center, Tehran University of Medical Sciences, Tehran, Iran; Department of Ophthalmology, Gavin Herbert Eye Institute, University of California Irvine, Irvine, California.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Nourinia', 'Affiliation': 'Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Homayoun', 'Initials': 'H', 'LastName': 'Nikkhah', 'Affiliation': 'Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'N Venkatesh', 'Initials': 'NV', 'LastName': 'Prajna', 'Affiliation': 'Aravind Eye Hospitals, Madurai, India.'}, {'ForeName': 'Chandrasekharan', 'Initials': 'C', 'LastName': 'Krishnan', 'Affiliation': 'Tufts University Medical School, Boston, Massachusetts.'}, {'ForeName': 'Sonal', 'Initials': 'S', 'LastName': 'Tuli', 'Affiliation': 'Department of Ophthalmology, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Green', 'Affiliation': 'Sinai Hospital, Baltimore, Maryland.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Srikumaran', 'Affiliation': 'Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Ankoor S', 'Initials': 'AS', 'LastName': 'Shah', 'Affiliation': ""Boston Children's Hospital, Harvard Medical School Departments of Ophthalmology, Boston, Massachusetts.""}, {'ForeName': 'Iason S', 'Initials': 'IS', 'LastName': 'Mantagos', 'Affiliation': ""Boston Children's Hospital, Harvard Medical School Departments of Ophthalmology, Boston, Massachusetts.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Chiang', 'Affiliation': 'Department of Ophthalmology, Casey Eye Institute, Oregon Health & Science University, Portland, Oregon; Department of Medical Informatics & Clinical Epidemiology, Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'R V Paul', 'Initials': 'RVP', 'LastName': 'Chan', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Illinois Eye and Ear Infirmary, University of Illinois at Chicago, Chicago, Illinois; Center for Global Health, College of Medicine, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Loewenstein', 'Affiliation': 'Massachusetts Eye and Ear, Harvard Medical School, Department of Ophthalmology, Boston, Massachusetts. Electronic address: John_Loewenstein@meei.harvard.edu.'}]",Journal of AAPOS : the official publication of the American Association for Pediatric Ophthalmology and Strabismus,['10.1016/j.jaapos.2018.11.008']
1175,31800551,Surgical Decompression or Corticosteroid Treatment of Indirect Traumatic Optic Neuropathy: A Randomized Controlled Trial.,"BACKGROUND


Traumatic optic neuropathy (TON) is a rare cause of severe permanent visual impairment after injury. Traumatic optic neuropathy may occur due to sharp trauma (direct injury) that damages the optic nerve directly or due to damage from the transmitted forces after a concussive blow to the head or orbit (indirect injury). The management of indirect TON remains controversial. Either surgical decompression or mega dose corticosteroid is used for managing indirect TON. However, no consensus exists regarding the definitive treatment.
MATERIALS AND METHODS


We designed a randomized controlled trial study to investigate this issue. Only patients with indirect TON and normal vision before the injury were enrolled. The patients' data were recorded, and fine cut facial computed tomography scan was performed to exclude those with retrobulbar hematoma. All the study subjects were randomly allocated to either the mega dose steroid (30 mg/kg stat and 15 mg/kg every 6 hours for 3 days) group or the surgical decompression group. The patients were followed up at 1 week, 1 month, 3 months, 6 months, and 9 months. During each follow-up, the Snellen visual acuity (VA), visual field, color change, fundus findings, and intraocular pressure were evaluated. These data were compared and analyzed using the Mann-Whitney U test and odds ratio. The short form questionnaire was used to analyze the lift quality difference between the two groups.
RESULTS


Thirty patients were enrolled, 12 in the surgical group and 18 in the steroid treatment group. There were no significant differences in the improvement rate, improvement degree, and life quality between the groups. However, the odds ratios are 5, 10, 2.5, and nonavailable in the cutoff points of no light perception (NLP), light perception (LP), hand movement, and counting finger in surgery group. In steroid group, they are 1, 1, 1, 1.83 in each cutoff points. Patients with better VA than NLP had better life quality than those with NLP VA (P = 0.005). Other cutoff point groups had no significant difference.
CONCLUSIONS


Patients with worse initial VA (eg, NLP and LP) had a higher chance of benefiting from surgical treatment and experiencing improvements in the life quality.",2020,Patients with better VA than NLP had better life quality than those with NLP VA (P = 0.005).,"['Indirect Traumatic Optic Neuropathy', 'Thirty patients were enrolled, 12 in the surgical group and 18 in the steroid treatment group', 'Only patients with indirect TON and normal vision before the injury were enrolled']","['NLP', 'steroid', 'surgical decompression group', 'surgical decompression or mega dose corticosteroid', 'Surgical Decompression or Corticosteroid']","['improvement rate, improvement degree, and life quality', 'life quality', 'Snellen visual acuity (VA), visual field, color change, fundus findings, and intraocular pressure', 'lift quality difference', 'light perception (NLP), light perception (LP), hand movement, and counting finger']","[{'cui': 'C0439852', 'cui_str': 'Indirect (qualifier value)'}, {'cui': 'C0161398', 'cui_str': 'Second Cranial Nerve Injuries'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439216', 'cui_str': 'tonne (qualifier value)'}, {'cui': 'C0234622', 'cui_str': 'Emmetropia'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]","[{'cui': 'C0763527', 'cui_str': 'NLP (protease)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0376530', 'cui_str': 'Decompression, Surgical'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C1827708', 'cui_str': 'Snellen visual acuity'}, {'cui': 'C0042826', 'cui_str': 'Visual Fields'}, {'cui': 'C0475330', 'cui_str': 'Color change (qualifier value)'}, {'cui': 'C0227817', 'cui_str': 'Uterine Fundus'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0181620', 'cui_str': 'Lift'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0016129', 'cui_str': 'Fingers'}]",30.0,0.0575043,Patients with better VA than NLP had better life quality than those with NLP VA (P = 0.005).,"[{'ForeName': 'Hsin-Hung', 'Initials': 'HH', 'LastName': 'Chen', 'Affiliation': 'From the Department of Plastic and Reconstructive Surgery, Chang Gung Memorial Hospital at Keelung, College of Medicine, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Min-Chao', 'Initials': 'MC', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Chia-Hsuan', 'Initials': 'CH', 'LastName': 'Tsai', 'Affiliation': ''}, {'ForeName': 'Chun-Hao', 'Initials': 'CH', 'LastName': 'Pan', 'Affiliation': ''}, {'ForeName': 'Yu-Te', 'Initials': 'YT', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Chien-Tzung', 'Initials': 'CT', 'LastName': 'Chen', 'Affiliation': ''}]",Annals of plastic surgery,['10.1097/SAP.0000000000002186']
1176,31232909,Repetitive Transcranial Magnetic Stimulation in the Treatment of Skin Picking Disorder: An Exploratory Trial.,"OBJECTIVES


Skin picking disorder (SPD) falls into the category of ""obsessive-compulsive disorder and related disorders"" in the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition). Repetitive transcranial magnetic stimulation (rTMS) treatment has been reported to be a promising therapy in obsessive-compulsive disorder-related disorders. The purpose of this study was to demonstrate the efficacy of rTMS treatment in patients with SPD.
METHODS


Fifteen patients with SPD were assigned to receive 3 weeks' treatment with either active (n = 8) or sham rTMS targeting the pre-supplementary motor area. Patients were evaluated using the Beck Depression Inventory, Beck Anxiety Inventory, Skin Picking Impact Scale, and the Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation. Response to treatment was defined as a ≥35% decrease on Yale-Brown Obsessive Compulsive Scale modified for Neurotic Excoriation.
RESULTS


Treatment response was achieved in 62.5% of patients (5/8) in the active group and 33.3% of patients (2/6) in the sham group. However, there were no significant differences between the groups in terms of primary and secondary outcomes.
CONCLUSIONS


In this exploratory study, active rTMS could not be demonstrated to be superior over sham in treatment of SPD. The results of this study indicate the need for further rTMS studies to be conducted with larger sample sizes and subtypes of SPD.",2020,"RESULTS


Treatment response was achieved in 62.5% of patients (5/8) in the active group and 33.3% of patients (2/6) in the sham group.","['patients with SPD.\nMETHODS\n\n\nFifteen patients with SPD', 'Picking Disorder']","['Repetitive Transcranial Magnetic Stimulation', 'rTMS', 'Repetitive transcranial magnetic stimulation (rTMS', 'active (n = 8) or sham rTMS targeting the pre-supplementary motor area']","['Yale-Brown Obsessive Compulsive Scale modified for Neurotic Excoriation', 'Skin', 'Beck Depression Inventory, Beck Anxiety Inventory, Skin Picking Impact Scale, and the Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C3496174', 'cui_str': 'Supplementary Motor Area'}]","[{'cui': 'C0678579', 'cui_str': 'Brown'}, {'cui': 'C0222045'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1274184', 'cui_str': 'Factitious skin disease'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory (assessment scale)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]",15.0,0.039709,"RESULTS


Treatment response was achieved in 62.5% of patients (5/8) in the active group and 33.3% of patients (2/6) in the sham group.","[{'ForeName': 'Efruz Pirdoğan', 'Initials': 'EP', 'LastName': 'Aydin', 'Affiliation': 'From the Departments of Psychiatry.'}, {'ForeName': 'Jülide Güler', 'Initials': 'JG', 'LastName': 'Kenar', 'Affiliation': 'From the Departments of Psychiatry.'}, {'ForeName': 'İlknur Kivanc', 'Initials': 'İK', 'LastName': 'Altunay', 'Affiliation': 'Dermatology, Şişli Hamidiye Etfal Teaching and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Derya', 'Initials': 'D', 'LastName': 'Kaymak', 'Affiliation': 'From the Departments of Psychiatry.'}, {'ForeName': 'Ömer Akil', 'Initials': 'ÖA', 'LastName': 'Özer', 'Affiliation': 'From the Departments of Psychiatry.'}, {'ForeName': 'Kayihan Oğuz', 'Initials': 'KO', 'LastName': 'Karamustafalioğlu', 'Affiliation': 'From the Departments of Psychiatry.'}]",The journal of ECT,['10.1097/YCT.0000000000000616']
1177,29486869,"Neural Signaling of Cortisol, Childhood Emotional Abuse, and Depression-Related Memory Bias.","BACKGROUND


Cortisol has potent effects on learning and neuroplasticity, but little is known about its effects on negative memory biases in depression. Animal models show that aversive caregiving alters effects of glucocorticoids (primarily corticosterone in rodents and cortisol in primates) on learning and neuroplasticity into adulthood.
METHODS


We investigated whether history of childhood emotional abuse (EA) moderated effects of cortisol administration (CORT) versus placebo on emotional memory formation in depression. Participants included 75 unmedicated women with varying levels of depression severity and/or EA history. In a double-blind crossover investigation, we used functional magnetic resonance imaging to measure effects of CORT (vs. placebo) on neural function during emotional memory formation.
RESULTS


CORT eliminated the well-known relationship between depression severity and negative memory bias, a finding explained by EA severity. For women with a history of severe EA, CORT reduced depression-related negative memory bias and normalized recall for pleasant stimuli. EA severity also moderated CORT effects on neural function: in women with history of severe EA, CORT increased activation in the supplementary motor area during viewing of unpleasant relative to pleasant pictures. Additionally, supplementary motor area activation predicted reduced negative bias for pictures encoded during CORT.
CONCLUSIONS


These results suggest that increasing cortisol signaling may be neurocognitively beneficial in depressed women with a history of maltreatment. The findings corroborate prior research suggesting that presence or absence of adverse caregiving is etiologically important in depression. These findings suggest potential neurocognitive mechanisms of therapeutics targeting cortisol signaling, which show promise in treating affective disorders.",2018,"For women with a history of severe EA, CORT reduced depression-related negative memory bias and normalized recall for pleasant stimuli.","['Participants included 75 unmedicated women with varying levels of depression severity and/or EA history', 'women with history of severe EA', 'depression']","['glucocorticoids', 'cortisol administration (CORT) versus placebo', 'CORT (vs. placebo']","['neural function', 'Neural Signaling of Cortisol, Childhood Emotional Abuse, and Depression-Related Memory Bias']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0730557', 'cui_str': 'Emotional abuse (event)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0005346', 'cui_str': 'Bias'}]",75.0,0.18797,"For women with a history of severe EA, CORT reduced depression-related negative memory bias and normalized recall for pleasant stimuli.","[{'ForeName': 'Heather C', 'Initials': 'HC', 'LastName': 'Abercrombie', 'Affiliation': 'Department of Psychiatry, University of Wisconsin-Madison, Madison, Wisconsin. Electronic address: heather.abercrombie@wisc.edu.'}, {'ForeName': 'Carlton P', 'Initials': 'CP', 'LastName': 'Frost', 'Affiliation': 'Department of Psychiatry, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Erin C', 'Initials': 'EC', 'LastName': 'Walsh', 'Affiliation': 'Department of Psychiatry, University of Wisconsin-Madison, Madison, Wisconsin; University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Roxanne M', 'Initials': 'RM', 'LastName': 'Hoks', 'Affiliation': 'Department of Psychiatry, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'M Daniela', 'Initials': 'MD', 'LastName': 'Cornejo', 'Affiliation': 'Department of Psychiatry, University of Wisconsin-Madison, Madison, Wisconsin; University of California, San Diego, San Diego, California.'}, {'ForeName': 'Maggie C', 'Initials': 'MC', 'LastName': 'Sampe', 'Affiliation': 'Department of Psychiatry, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Allison E', 'Initials': 'AE', 'LastName': 'Gaffey', 'Affiliation': 'Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Plante', 'Affiliation': 'Department of Psychiatry, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Charlotte O', 'Initials': 'CO', 'LastName': 'Ladd', 'Affiliation': 'Department of Psychiatry, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Rasmus M', 'Initials': 'RM', 'LastName': 'Birn', 'Affiliation': 'Department of Psychiatry, University of Wisconsin-Madison, Madison, Wisconsin.'}]",Biological psychiatry. Cognitive neuroscience and neuroimaging,['10.1016/j.bpsc.2017.11.005']
1178,31158718,Motivational interviewing prior to cognitive behavioural treatment for social anxiety disorder: A randomised controlled trial.,"BACKGROUND


We examined whether providing three sessions of treatment based on motivational interviewing (MI) prior to Cognitive Behavioral Therapy (CBT) for Social Anxiety Disorder (SAD) improved outcomes.
METHODS


Participants diagnosed with SAD (N = 186) were randomly allocated to receive three sessions of MI (MI+CBT; n = 85) or supportive counselling (SC+CBT; n = 101) prior to a 12-week group CBT program. Assessments occurred at baseline, after preparatory treatment, after CBT, and at 6-months follow-up. Outcomes were expectations for change, number of CBT sessions attended, self- and clinician-rated CBT homework completion, and self- and clinician-rated social anxiety severity.
RESULTS


Conditions did not differ significantly on expectations for change, number of CBT sessions attended, or clinician-rated homework completion. Self-rated homework completion was greater in MI+CBT than in SC+CBT. Change over time in social anxiety severity did not differ between conditions overall, however, this outcome was significantly moderated by two variables; those in MI+CBT, as compared to SC+CBT, showed significantly poorer outcomes on self-reported social anxiety severity if they were higher in change readiness and significantly better outcomes on clinician-rated social anxiety severity if they were higher in functional impairment.
LIMITATIONS


Although therapists in MI sessions were rated as behaving more consistently with MI than therapists in SC sessions, some MI consistent behaviors occurred in the SC sessions.
CONCLUSIONS


Addition of a MI-based discussion prior to evidence-based CBT appears to benefit people with SAD who have high functional impairment but may interfere with outcomes for those higher in readiness for change.",2019,"RESULTS


Conditions did not differ significantly on expectations for change, number of CBT sessions attended, or clinician-rated homework completion.","['Participants diagnosed with SAD (N\u202f=\u202f186', 'social anxiety disorder']","['MI (MI+CBT; n\u202f=\u202f85) or supportive counselling (SC+CBT; n\u202f=\u202f101) prior to a 12-week group CBT program', 'motivational interviewing (MI) prior to Cognitive Behavioral Therapy (CBT', 'Motivational interviewing prior to cognitive behavioural treatment']","['Self-rated homework completion', 'expectations for change, number of CBT sessions attended, self- and clinician-rated CBT homework completion, and self- and clinician-rated social anxiety severity', 'self-reported social anxiety severity', 'MI consistent behaviors', 'clinician-rated social anxiety severity', 'Change over time in social anxiety severity']","[{'cui': 'C0031572', 'cui_str': 'Social Anxiety Disorder'}]","[{'cui': 'C3697360', 'cui_str': 'Supportive counseling'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0589414', 'cui_str': 'Homework, function (observable entity)'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0424166', 'cui_str': 'Social Anxiety'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",186.0,0.0409547,"RESULTS


Conditions did not differ significantly on expectations for change, number of CBT sessions attended, or clinician-rated homework completion.","[{'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Peters', 'Affiliation': 'Centre for Emotional Health, Department of Psychology, Macquarie University, NSW 2109, Australia. Electronic address: Lorna.Peters@mq.edu.au.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Romano', 'Affiliation': 'Centre for Emotional Health, Department of Psychology, Macquarie University, NSW 2109, Australia.'}, {'ForeName': 'Yulisha', 'Initials': 'Y', 'LastName': 'Byrow', 'Affiliation': 'Centre for Emotional Health, Department of Psychology, Macquarie University, NSW 2109, Australia.'}, {'ForeName': 'Bree', 'Initials': 'B', 'LastName': 'Gregory', 'Affiliation': 'Centre for Emotional Health, Department of Psychology, Macquarie University, NSW 2109, Australia.'}, {'ForeName': 'Lauren F', 'Initials': 'LF', 'LastName': 'McLellan', 'Affiliation': 'Centre for Emotional Health, Department of Psychology, Macquarie University, NSW 2109, Australia.'}, {'ForeName': 'Keila', 'Initials': 'K', 'LastName': 'Brockveld', 'Affiliation': 'Centre for Emotional Health, Department of Psychology, Macquarie University, NSW 2109, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Baillie', 'Affiliation': 'Centre for Emotional Health, Department of Psychology, Macquarie University, NSW 2109, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Gaston', 'Affiliation': 'Centre for Emotional Health, Department of Psychology, Macquarie University, NSW 2109, Australia.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Rapee', 'Affiliation': 'Centre for Emotional Health, Department of Psychology, Macquarie University, NSW 2109, Australia.'}]",Journal of affective disorders,['10.1016/j.jad.2019.05.042']
1179,31243574,Impact of drains on nausea and vomiting after thyroid and parathyroid surgery: a randomized controlled trial.,"OBJECTIVE


Nausea and vomiting are common side effects following thyroid and parathyroid surgery. In a prospective controlled randomized trial, postoperative nausea and vomiting (PONV) and the number of episodes of vomiting were defined as two primary endpoints. We analysed whether the placement of drains after thyroid or parathyroid surgery enhances PONV and/or influences vomiting.
PATIENTS AND METHODS


From November 2007 to January 2012, 136 consecutive patients were included for thyroid or parathyroid surgery and were randomly assigned to group A (drain, n = 69) or group B (no drain, n = 67). PONV was assessed with visual analogue scale (VAS; range 0 to 10) measurements. Furthermore, episodes of vomiting as well as analgetic and antiemetic therapies were recorded. Difference in neck circumference was compared pre- and postoperatively.
RESULTS


Patients' characteristics did not differ between group A and B. Postoperative VAS values for pain were 2.4 ± 0.3 (group A) and 2.6 ± 0.2 (group B) (p = 0.62), and for nausea 1.4 ± 0.2 (group A) and 1.1 ± 0.2 (group B) (p = 0.57). The relative occurrences of episodes for postoperative vomiting were equal in both groups 0.3 ± 0.1 (p = 1.0). Antiemetic drugs were administered 37 times (group A) and 18 times (group B) (p = 0.099). The total number of treatments of patients with antiemetic drugs was 23 (33.3%) in group A vs. 13 (19.4%) in group B (p = 0.081). The neck circumference postoperatively was significantly larger in group B (p = 0.0025).
CONCLUSIONS


Drains after surgery do not enhance postoperative pain, nausea and vomiting. The placement of drains in thyroid surgery is recommended to avoid relevant fluid collection. Drains however may influence the amount of antiemetic drug requirements.
TRIAL REGISTRATION


CLINICALTRIALS.
GOV IDENTIFIER


NCT01679418.",2019,The total number of treatments of patients with antiemetic drugs was 23 (33.3%) in group A vs. 13 (19.4%) in group B (p = 0.081).,"['From November 2007 to January 2012, 136 consecutive patients were included for thyroid or parathyroid surgery', 'after thyroid and parathyroid surgery']","['drains', 'thyroid and parathyroid surgery', 'parathyroid surgery enhances PONV']","['episodes of vomiting', 'nausea and vomiting', 'B. Postoperative VAS values for pain', 'relative occurrences of episodes for postoperative vomiting', 'number of episodes of vomiting', 'total number of treatments of patients with antiemetic drugs', 'postoperative pain, nausea and vomiting', 'neck circumference', 'neck circumference postoperatively', 'postoperative nausea and vomiting (PONV']","[{'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C0030518', 'cui_str': 'Parathyroid structure (body structure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C0030518', 'cui_str': 'Parathyroid structure (body structure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0520909', 'cui_str': 'PONV'}]","[{'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0520905', 'cui_str': 'Postoperative Emesis'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C1630403', 'cui_str': 'Neck circumference'}, {'cui': 'C0520909', 'cui_str': 'PONV'}]",136.0,0.207438,The total number of treatments of patients with antiemetic drugs was 23 (33.3%) in group A vs. 13 (19.4%) in group B (p = 0.081).,"[{'ForeName': 'B M', 'Initials': 'BM', 'LastName': 'Künzli', 'Affiliation': 'Department of Surgery, Hospital of Baselland, Affiliated with the University of Basel, Liestal, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Walensi', 'Affiliation': 'Department of Surgery, Hospital of Baselland, Affiliated with the University of Basel, Liestal, Switzerland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wilimsky', 'Affiliation': 'Department of Surgery, Hospital of Baselland, Affiliated with the University of Basel, Liestal, Switzerland.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bucher', 'Affiliation': 'Department of Surgery, Hospital of Baselland, Affiliated with the University of Basel, Liestal, Switzerland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bührer', 'Affiliation': 'Department of Surgery, Hospital of Baselland, Affiliated with the University of Basel, Liestal, Switzerland.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kull', 'Affiliation': 'Department of Surgery, Hospital of Baselland, Affiliated with the University of Basel, Liestal, Switzerland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zuse', 'Affiliation': 'Department of Surgery, HIRSLANDEN Private Hospital Group, Klinik Beau-Site, Schänzlihalde 1, CH - 3013, Bern, Switzerland.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Maurer', 'Affiliation': 'Department of Surgery, Hospital of Baselland, Affiliated with the University of Basel, Liestal, Switzerland. christoph.maurer@hin.ch.'}]",Langenbeck's archives of surgery,['10.1007/s00423-019-01799-6']
1180,30388714,Maternal Epidural Steroids to Prevent Neonatal Exposure to Hyperthermia and Inflammation.,"BACKGROUND


Epidural analgesia is associated with a fourfold increased rate of intrapartum fever. The likely pathophysiology is a noninfectious maternal inflammatory activation. Safe interventions to reduce maternal and neonatal exposures to intrapartum fever and inflammation are needed.
OBJECTIVE


The purpose of this study was to determine if prophylactic epidural steroids decrease fetal exposure to hyperthermia and inflammatory cytokines following epidural analgesia.
STUDY DESIGN


This is a randomized, double-blinded, placebo controlled trial. Term nulliparous women requesting epidural analgesia received 80 mg methylprednisolone or preservative-free normal saline via the epidural catheter at placement. The primary outcome was maternal temperature >100.4°F. Secondary outcomes included fetal exposure to inflammation as assessed by cord blood interleukin-6 (IL-6) levels and rates of funisitis. Power analysis estimated a sample size requirement of 276, but new Food and Drug Administration (FDA) recommendations advising a black box warning on epidural steroids resulted in early study termination.
RESULTS


A total of 116 subjects were enrolled: 58 treatments and 58 placebos. There was no difference in the rate of maternal intrapartum fever or cord blood IL-6 levels between treatment arms. No complications listed in the FDA warning occurred.
CONCLUSION


Prophylactic epidural methylprednisolone was not effective in reducing intrapartum fever or neonatal inflammation following epidural analgesia. Alternate mechanisms and preventative strategies should be considered.",2019,There was no difference in the rate of maternal intrapartum fever or cord blood IL-6 levels between treatment arms.,"['Term nulliparous women requesting', 'A total of 116 subjects were enrolled: 58 treatments and 58']","['Prophylactic epidural methylprednisolone', 'placebo', 'epidural analgesia received 80\u2009mg methylprednisolone or preservative-free normal saline', 'placebos', 'prophylactic epidural steroids']","['maternal temperature >100.4°F', 'intrapartum fever or neonatal inflammation', 'rate of maternal intrapartum fever or cord blood IL-6 levels', 'fetal exposure to inflammation as assessed by cord blood interleukin-6 (IL-6) levels and rates of funisitis']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0002769', 'cui_str': 'Analgesia, Epidural'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum (qualifier value)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C1275592', 'cui_str': 'Funisitis'}]",116.0,0.581585,There was no difference in the rate of maternal intrapartum fever or cord blood IL-6 levels between treatment arms.,"[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Goodier', 'Affiliation': 'Department of Maternal-Fetal Medicine, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Newman', 'Affiliation': 'Department of Maternal-Fetal Medicine, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Latha', 'Initials': 'L', 'LastName': 'Hebbar', 'Affiliation': 'Department of Anesthesiology, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Ross', 'Affiliation': 'Department of Neonatology, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Schandl', 'Affiliation': 'Department of Pathology, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Goetzl', 'Affiliation': 'Department of Maternal-Fetal Medicine, University of Texas Health Science Center, Houston, Texas.'}]",American journal of perinatology,['10.1055/s-0038-1675329']
1181,31738072,Improvement in women's cardiovascular functioning during cognitive-behavioral therapy for alcohol use disorder.,"The cardiovascular system is disrupted by chronic excessive alcohol use and often impaired in individuals with an alcohol use disorder (AUD). Less is known about cardiovascular recovery when an individual receives treatment for AUD. This observational study aimed to extend the growing body of evidence for cardiovascular biomarkers and intervention targets in the treatment of AUD. We examined cardiovascular function in 92 women before and after 12 weeks of cognitive-behavioral therapy (CBT) for AUD. Participants were recruited exclusively from a randomized clinical trial comparing group versus individual CBT treatment strategies (parent study); no control group of untreated, but treatment-seeking women was available. Demographic and drinking data were obtained from the parent study. Cardiovascular data were collected as part of this separate study, prior to and following the clinical trial. Mixed-model analyses revealed multiple within-person cardiovascular changes indicative of improving health from pre- to posttreatment, including reduced heart rate and vessel stiffness as well as increased heart rate variability and baroreflex sensitivity. These significant improvements remained when extent of drinking during treatment was included in the models, suggesting that active ingredients of AUD treatment may serve to benefit physical health over and above drinking reductions. Future studies should assess the time course of cardiovascular recovery during addiction treatment and the mechanisms by which evidence-based AUD treatments may benefit physical as well as mental health. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"These significant improvements remained when extent of drinking during treatment was included in the models, suggesting that active ingredients of AUD treatment may serve to benefit physical health over and above drinking reductions.","['individuals with an alcohol use disorder (AUD', ""women's cardiovascular functioning during cognitive-behavioral therapy for alcohol use disorder"", '92 women before and after 12 weeks of cognitive-behavioral therapy (CBT) for AUD']","['individual CBT treatment strategies (parent study); no control group of untreated, but treatment-seeking women was available']","['heart rate variability and baroreflex sensitivity', 'heart rate and vessel stiffness']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0007227', 'cui_str': 'Cardiovascular Physiology'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0206162', 'cui_str': 'Reflex, Baroreceptor'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}]",2019.0,0.0455963,"These significant improvements remained when extent of drinking during treatment was included in the models, suggesting that active ingredients of AUD treatment may serve to benefit physical health over and above drinking reductions.","[{'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Buckman', 'Affiliation': 'Department of Kinesiology and Health.'}, {'ForeName': 'Bronya', 'Initials': 'B', 'LastName': 'Vaschillo', 'Affiliation': 'Department of Kinesiology and Health.'}, {'ForeName': 'Evgeny G', 'Initials': 'EG', 'LastName': 'Vaschillo', 'Affiliation': 'Department of Kinesiology and Health.'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Epstein', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Tam T', 'Initials': 'TT', 'LastName': 'Nguyen-Louie', 'Affiliation': 'SDSU/UCSD Joint Doctoral Program in Clinical Psychology.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Lesnewich', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Eddie', 'Affiliation': 'Massachusetts General Hospital.'}, {'ForeName': 'Marsha E', 'Initials': 'ME', 'LastName': 'Bates', 'Affiliation': 'Department of Kinesiology and Health.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000524']
1182,31209560,Oral vitamin A supplementation in very low birth weight neonates: a randomized controlled trial.,"This randomized double-blind placebo-controlled trial evaluated the effects of early postnatal oral vitamin A supplementation (VAS) in 196 inborn very-low birth weight (VLBW) infants requiring respiratory support at 24 h of age. Eligible infants were randomized to receive aqueous syrup of vitamin A (10,000 IU of retinol/dose; n = 98) or placebo (n = 98) on alternate days for 28 days. Primary outcome variable was composite incidence of all-cause mortality and/or oxygen requirement for 28 days. Secondary outcome variables were safety/tolerability of VAS, serum retinol concentration at recruitment and day 28, duration of oxygen requirement and respiratory support and incidences of complications. On intention-to-treat analysis, composite incidence of all-cause mortality and oxygen requirement for 28 days was significantly lower in vitamin A group (relative risk (95% confidence interval), 0.440 (0.229-0.844); p < 0.05, number needed to benefit, 7). Requirement and duration of oxygen supplementation and non-invasive respiratory support, incidences of late-onset sepsis, patent ductus arteriosus, and duration of hospital stay were also significantly lower in vitamin A group. Serum retinol concentration improved significantly after VAS. No major adverse effect was observed.Conclusions: Early postnatal oral VAS was associated with better composite outcome of all-cause mortality and oxygen requirement without any major adverse effects.Clinical Trial Registration: Clinical Trials Registry of India (CTRI/2017/03/008131). What is Known: • Postnatal intramuscular vitamin A supplementation improves the survival, respiratory outcome and other morbidities in very low birth weight neonates without major adverse effects. • Limited studies on oral vitamin A supplementation did not document substantial benefits. What is New: • Early postnatal alternate-day oral vitamin A supplementation at the dose of 10,000 IU/dose for 28 days improves the composite outcome of death and oxygen requirement in very low birth weight neonates with respiratory distress • No major adverse effects were documented.",2019,No major adverse effects were documented.,"['very low birth weight neonates with respiratory distress •', 'very low birth weight neonates', '196 inborn very-low birth weight (VLBW) infants requiring respiratory support at 24\xa0h of age', 'Eligible infants']","['placebo', 'aqueous syrup of vitamin A (10,000\xa0IU of retinol/dose; n\u2009=\u200998) or placebo', 'vitamin A supplementation', 'Oral vitamin A supplementation', 'early postnatal oral vitamin A supplementation (VAS', 'oral vitamin']","['Requirement and duration of oxygen supplementation and non-invasive respiratory support, incidences of late-onset sepsis, patent ductus arteriosus, and duration of hospital stay', 'composite outcome of death and oxygen requirement', 'Serum retinol concentration', 'survival, respiratory outcome and other morbidities', 'composite incidence of all-cause mortality and/or oxygen requirement for 28\xa0days', 'safety/tolerability of VAS, serum retinol concentration at recruitment and day 28, duration of oxygen requirement and respiratory support and incidences of complications']","[{'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress (finding)'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0282667', 'cui_str': 'Infant, Very Low Birth Weight'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0458173', 'cui_str': 'Syrup (substance)'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0087161', 'cui_str': 'All-Trans-Retinol'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4524019', 'cui_str': 'Vitamin A supplementation'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0919655', 'cui_str': 'Oxygen supplementation'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C3495549', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0087161', 'cui_str': 'All-Trans-Retinol'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",,0.696425,No major adverse effects were documented.,"[{'ForeName': 'Sriparna', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'Neonatal Unit, Department of Pediatrics, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India. drsriparnabasu@rediffmail.com.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Khanna', 'Affiliation': 'Neonatal Unit, Department of Pediatrics, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.'}, {'ForeName': 'Ragini', 'Initials': 'R', 'LastName': 'Srivastava', 'Affiliation': 'Department of Biochemistry, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.'}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Neonatal Unit, Department of Pediatrics, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.'}]",European journal of pediatrics,['10.1007/s00431-019-03412-w']
1183,31221722,"Botulinum neurotoxin treatment in jerky and tremulous functional movement disorders: a double-blind, randomised placebo-controlled trial with an open-label extension.","OBJECTIVE


To study the effect of botulinum neurotoxin (BoNT) treatment in jerky and tremulous functional movement disorders (FMD).
METHODS


Patients with invalidating, chronic (>1 year) symptoms were randomly assigned to two subsequent treatments with BoNT or placebo every 3 months with stratification according to symptom localisation. Improvement on the dichotomised Clinical Global Impression-Improvement scale (CGI-I) (improvement vs no change or worsening) at 4 months, assessed by investigators blinded to the allocated treatment was the primary outcome. Subsequently all patients were treated with BoNT in a ten month open-label phase.
RESULTS


Between January 2011 and February 2015 a total of 239 patients were screened for eligibility of whom 48 patients were included. No difference was found on the primary outcome (BoNT 16 of 25 (64.0%) vs Placebo 13 of 23 patients (56.5%); proportional difference 0.075 (95% CI -0.189 to 0.327; p=0.77). Secondary outcomes (symptom severity, disease burden, disability, quality of life and psychiatric symptoms) showed no between-group differences. The open-label phase showed improvement on the CGI-I in 19/43 (44.2%) of remaining patients, with a total of 35/43 (81.4%) improvement compared with baseline.
CONCLUSIONS


In this double-blind randomised controlled trial of BoNT for chronic jerky and tremulous FMD, we found no evidence of improved outcomes compared with placebo. Motor symptoms improved in a large proportion in both groups which was sustained in the open-label phase. This study underlines the substantial potential of chronic jerky and tremulous FMD patients to recover and may stimulate further exploration of placebo-therapies in these patients.
TRIAL REGISTRATION NUMBER


NTR2478.",2019,Improvement on the dichotomised Clinical Global Impression-Improvement scale (CGI-I),"['jerky and tremulous functional movement disorders', 'jerky and tremulous functional movement disorders (FMD', 'Between January 2011 and February 2015 a total of 239 patients were screened for eligibility of whom 48 patients were included', 'Patients with invalidating, chronic (>1\u2009year']","['botulinum neurotoxin (BoNT', 'BoNT or placebo', 'placebo', 'Botulinum neurotoxin']","['dichotomised Clinical Global Impression-Improvement scale (CGI-I', 'CGI', 'Motor symptoms', 'Secondary outcomes (symptom severity, disease burden, disability, quality of life and psychiatric symptoms']","[{'cui': 'C4273557', 'cui_str': 'Functional movement disorder'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C4280965', 'cui_str': '>1'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1295507', 'cui_str': 'Botulinum neurotoxin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms (finding)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom (finding)'}]",239.0,0.657225,Improvement on the dichotomised Clinical Global Impression-Improvement scale (CGI-I),"[{'ForeName': 'Yasmine Emma Maria', 'Initials': 'YEM', 'LastName': 'Dreissen', 'Affiliation': 'Neurology and Clinical Neurophysiology, Amsterdam University Medical Center, location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Joke M', 'Initials': 'JM', 'LastName': 'Dijk', 'Affiliation': 'Neurology, Amsterdam University Medical Center, location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Jeannette M', 'Initials': 'JM', 'LastName': 'Gelauff', 'Affiliation': 'Neurology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Evelien', 'Initials': 'E', 'LastName': 'Zoons', 'Affiliation': 'Neurology, Amsterdam University Medical Center, location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Daniël', 'Initials': 'D', 'LastName': 'van Poppelen', 'Affiliation': 'Neurology, Amsterdam University Medical Center, location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Maria Fiorella', 'Initials': 'MF', 'LastName': 'Contarino', 'Affiliation': 'Neurology, Haga Teaching Hospital, The Hague, The Netherlands.'}, {'ForeName': 'Rodi', 'Initials': 'R', 'LastName': 'Zutt', 'Affiliation': 'Neurology, Universitair Medisch Centrum Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Post', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Alexander G', 'Initials': 'AG', 'LastName': 'Munts', 'Affiliation': 'Neurology, Spaarne Gasthuis, Haarlem, The Netherlands.'}, {'ForeName': 'Johannes D', 'Initials': 'JD', 'LastName': 'Speelman', 'Affiliation': 'Neurology, Amsterdam University Medical Center, location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Danielle C', 'Initials': 'DC', 'LastName': 'Cath', 'Affiliation': 'Department of Clinical and Health Psychology, Altrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Rob J', 'Initials': 'RJ', 'LastName': 'de Haan', 'Affiliation': 'Clinical Research Unit, Amsterdam University Medical Center, location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Johannes Htm', 'Initials': 'JH', 'LastName': 'Koelman', 'Affiliation': 'Neurology and Clinical Neurophysiology, Amsterdam University Medical Center, location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Marina A J', 'Initials': 'MAJ', 'LastName': 'Tijssen', 'Affiliation': 'Neurology, Universitair Medisch Centrum Groningen, Groningen, The Netherlands m.a.j.de.koning-tijssen@umcg.nl.'}]","Journal of neurology, neurosurgery, and psychiatry",['10.1136/jnnp-2018-320071']
1184,31794034,"Effects of Simulation-Based Deliberate Practice on Nursing Students' Communication, Empathy, and Self-Efficacy.","BACKGROUND


Newly graduated nurses' communication ability often does not satisfy the needs of clinical sites. New training pedagogies are needed to help nursing students improve communication skills. This study aimed to evaluate the effects of simulation-based deliberate practice on cultivating nursing students' communication, empathy, and self-efficacy.
METHOD


The study was a randomized controlled trial. A total of 132 first-year nursing students participated in the study at a nursing school in China. The intervention was guided by simulation-based education and deliberate practice. The Clinical Communication Ability Scale, Jefferson Scale of Empathy-Health Professionals, and General Self-Efficacy Scale were used to measure the students' outcomes.
RESULTS


After the intervention, students' scores of clinical communication ability, empathy, and self-efficacy in the experimental group all increased significantly, compared with those of the control group.
CONCLUSION


The simulation-based deliberate practice program is a feasible teaching method targeting improvement in nursing students' communication, empathy, and self-efficacy. [J Nurs Educ. 2019;58(12):681-689.].",2019,"The simulation-based deliberate practice program is a feasible teaching method targeting improvement in nursing students' communication, empathy, and self-efficacy.",['A total of 132 first-year nursing students participated in the study at a nursing school in China'],"['Simulation-Based Deliberate Practice', 'simulation-based deliberate practice']","['clinical communication ability, empathy, and self-efficacy', ""Nursing Students' Communication, Empathy, and Self-Efficacy"", 'Clinical Communication Ability Scale, Jefferson Scale of Empathy-Health Professionals, and General Self-Efficacy Scale']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0036380', 'cui_str': 'Nurse Training Schools'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0565998', 'cui_str': 'Communication ability'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0222045'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",689.0,0.0215012,"The simulation-based deliberate practice program is a feasible teaching method targeting improvement in nursing students' communication, empathy, and self-efficacy.","[{'ForeName': 'Ju', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Gu', 'Affiliation': ''}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Rongyan', 'Initials': 'R', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Qiaoying', 'Initials': 'Q', 'LastName': 'Cai', 'Affiliation': ''}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Qinghui', 'Initials': 'Q', 'LastName': 'Meng', 'Affiliation': ''}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Wei', 'Affiliation': ''}]",The Journal of nursing education,['10.3928/01484834-20191120-02']
1185,31794039,The Influence of Gamification on Decision Making in Nursing Students.,"BACKGROUND


Gamification provides nursing students with a setting in which they can practice clinical reasoning and decision making in a realistic and secure way. The purpose of this study was to determine the influence of gamification on decision making in nursing students.
METHOD


A quasi-experimental study was performed with a control group and an experimental group. A convenience sample was used to select the participants. A total of 191 nursing students participated. Participants were randomly assigned to one of the groups.
RESULTS


On comparing the control group and experimental group, statistically significant differences were found in the following patterns: vigilance, buck passing, and procrastination.
CONCLUSION


Using gamification as part of nursing education increases satisfaction, creative thinking, and control, among other aspects, with little to no negative effects throughout the experience, which has a significant impact on decision making. [J Nurs Educ. 2019;58(12):718-722.].",2019,"On comparing the control group and experimental group, statistically significant differences were found in the following patterns: vigilance, buck passing, and procrastination.
","['nursing students', 'Nursing Students', '191 nursing students participated']",[],"['patterns: vigilance, buck passing, and procrastination']","[{'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}]",[],"[{'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0852885', 'cui_str': 'Bucking'}, {'cui': 'C0871142', 'cui_str': 'Procrastination'}]",722.0,0.0135392,"On comparing the control group and experimental group, statistically significant differences were found in the following patterns: vigilance, buck passing, and procrastination.
","[{'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'García-Viola', 'Affiliation': ''}, {'ForeName': 'José Miguel', 'Initials': 'JM', 'LastName': 'Garrido-Molina', 'Affiliation': ''}, {'ForeName': 'Verónica V', 'Initials': 'VV', 'LastName': 'Márquez-Hernández', 'Affiliation': ''}, {'ForeName': 'Genoveva', 'Initials': 'G', 'LastName': 'Granados-Gámez', 'Affiliation': ''}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Aguilera-Manrique', 'Affiliation': ''}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Gutiérrez-Puertas', 'Affiliation': ''}]",The Journal of nursing education,['10.3928/01484834-20191120-07']
1186,31216210,Videoconferencing psychotherapy for veterans with PTSD: Results from a randomized controlled non-inferiority trial.,"INTRODUCTION


Veterans with post-traumatic stress disorder (PTSD) face significant barriers that make it less likely for them to pursue treatment. A randomized controlled non-inferiority trial was used to determine if providing psychotherapy for PTSD via videoconference (VC) is as effective as in-person (IP) psychotherapy.
METHODS


All eligible veterans ( n  = 207) received cognitive processing therapy (CPT) to treat PTSD symptoms in one of the two treatment modalities. Participant symptoms were collected at baseline, post-treatment, and six months after treatment completion. The primary outcome measure, the Clinician-Administered PTSD Scale (CAPS), was used to assess PTSD diagnosis and symptom severity. Secondary outcomes included two self-report measures of symptom severity, the Post-traumatic Stress Disorder Checklist - Specific (PCL-S) for PTSD and the Patient Health Questionnaire - 9 (PHQ-9) for depressive symptoms. A linear mixed-effects model was used to assess non-inferiority for participants who completed treatment (completers) and those who were randomized to treatment (intention-to-treat (ITT)).
RESULTS


Both completer and ITT analyses showed that improvement in CAPS scores in the VC condition was non-inferior to that in the IP condition at six-month follow-up, but VC was inferior to IP for improvement in CAPS at post-treatment. Non-inferiority was supported by completer analyses for PCL-S and PHQ-9 in both post-treatment change and six-month follow-up change, and the ITT analysis supported the significant non-inferiority for PCL at post-treatment change.
DISCUSSION


These findings generally suggest that CPT delivered via VC can be as effective as IP for reducing the severity of PTSD symptoms.",2019,,['veterans with PTSD'],['Videoconferencing psychotherapy'],[],"[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}]",[],,0.134913,,"[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Thorp', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Moreno', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'Stephanie Y', 'Initials': 'SY', 'LastName': 'Wells', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'Lisa H', 'Initials': 'LH', 'LastName': 'Glassman', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'Angela C', 'Initials': 'AC', 'LastName': 'Busch', 'Affiliation': 'Veterans Medical Research Foundation, San Diego, CA, USA.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Zamora', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'Carie S', 'Initials': 'CS', 'LastName': 'Rodgers', 'Affiliation': 'Department of Medicine, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Carolyn B', 'Initials': 'CB', 'LastName': 'Allard', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'Leslie A', 'Initials': 'LA', 'LastName': 'Morland', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'Zia', 'Initials': 'Z', 'LastName': 'Agha', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19853947']
1187,31206579,Vida PURA: results from a pilot randomized trial of a culturally adapted screening and brief intervention to reduce unhealthy alcohol use among Latino day laborers.,"Latino immigrant men are at increased risk for unhealthy alcohol use. Vida PURA is a culturally adapted evidence-based intervention that consists of promotores providing screening and brief intervention to reduce unhealthy alcohol use among Latino immigrant men. The purpose was to assess the efficacy of Vida PURA in a pilot randomized control trial. Participants were screened for eligibility at a day labor worker center using the Alcohol Use Disorders Identification Test (AUDIT). Those with an AUDIT score ≥ 6 (N = 121) were randomized into an intervention (N = 77) or control group (N = 44). Participants in the intervention group received a brief intervention from a promotor including personalized feedback, motivational interviewing to assess their readiness to change, and referral to services. Participants in the control group received information about local substance use treatment services. We assessed changes in AUDIT scores, drinks per drinking day, drinking days, and frequency of heavy episodic drinking at 2 and 8 weeks following the baseline survey using a mixed-effects regression model. Many men had high AUDIT scores, indicating dependence. Both the intervention and control groups reduced their alcohol-related behaviors over time, but there were no significant differences between the groups. A culturally adapted brief intervention may not be enough to significantly reduce alcohol use among Latino day laborers, especially among those that are dependent. We discuss lessons learned from this trial, including the value of community-based approaches to reaching high-risk and underserved populations.",2019,"Both the intervention and control groups reduced their alcohol-related behaviors over time, but there were no significant differences between the groups.","['Participants were screened for eligibility at a day labor worker center using the Alcohol Use Disorders Identification Test (AUDIT', 'Latino immigrant men', 'Latino day laborers']","['Vida PURA', 'culturally adapted screening and brief intervention', 'brief intervention from a promotor including personalized feedback, motivational interviewing to assess their readiness to change, and referral to services', 'information about local substance use treatment services']","['AUDIT scores, drinks per drinking day, drinking days, and frequency of heavy episodic drinking']","[{'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test (assessment scale)'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0282163', 'cui_str': 'Immigrants'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0240146', 'cui_str': 'Laborer (occupation)'}]","[{'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0584065', 'cui_str': 'Referral to service (procedure)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0150359', 'cui_str': 'Substance use treatments and procedures'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}]",121.0,0.0243351,"Both the intervention and control groups reduced their alcohol-related behaviors over time, but there were no significant differences between the groups.","[{'ForeName': 'India J', 'Initials': 'IJ', 'LastName': 'Ornelas', 'Affiliation': 'Department of Health Services, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Suzanne R', 'Initials': 'SR', 'LastName': 'Doyle', 'Affiliation': 'Alcohol and Drug Abuse Institute, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Vanessa N', 'Initials': 'VN', 'LastName': 'Torres', 'Affiliation': 'Department of Health Services, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Samantha E', 'Initials': 'SE', 'LastName': 'Serrano', 'Affiliation': 'Department of Health Services, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Duran', 'Affiliation': 'School of Social Work, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Dennis M', 'Initials': 'DM', 'LastName': 'Donovan', 'Affiliation': 'Alcohol and Drug Abuse Institute, University of Washington, Seattle, WA, USA.'}]",Translational behavioral medicine,['10.1093/tbm/ibz071']
1188,31789457,Accelerated hair growth by combining thread monofilament and minoxidil in female androgenetic alopecia.,"BACKGROUND


Monofilament thread therapy (PLLA) and minoxidil have been used as alternative treatments for female androgenetic alopecia.
AIM


The aim was to determine the efficacy and safety of thread therapy combined with minoxidil in female androgenetic alopecia.
PATIENT AND METHODS


Twenty-seven women were enrolled in this randomized half-split study based on a left-head to the right-head pattern. Thread therapy (PLLA) treatment was unilaterally performed (once); minoxidil was bilaterally applied for 6 months. Global photographs and dermoscopy assessments were performed in the baseline and every 2 months till the end of treatment. Global photographs underwent blinded review by three independent dermatologists.
RESULTS


Mean hair density increased from 114 ± 27 to 143 ± 25/cm 2  (P < .001) in the combined group and from 113 ± 24 to 123 ± 19/cm 2  in the minoxidil group (P < .001). The mean change from baseline between the two groups was also compared (P = .003). Global photographs showed improvement in 93% (25/27) patients in the combined group and 52% (14/27) patients in the minoxidil group.
CONCLUSION


Poly-l-lactic acid microthread therapy combined with minoxidil may improve hair density, hair thickness, and hair appearance better than minoxidil alone.",2020,"RESULTS


Mean hair density increased from 114 ± 27 to 143 ± 25/cm 2  (P < .001) in the combined group and from 113 ± 24 to 123 ± 19/cm 2  in the minoxidil group (P < .001).","['female androgenetic alopecia', 'Twenty-seven women were enrolled in this randomized half-split study based on a left-head to the right-head pattern']","['Monofilament thread therapy (PLLA) and minoxidil', 'Thread therapy (PLLA', 'minoxidil']","['efficacy and safety', 'Mean hair density', 'hair density, hair thickness, and hair appearance better']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0162311', 'cui_str': 'Pattern Baldness'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0546911', 'cui_str': 'To the right (qualifier value)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]","[{'cui': 'C4319672', 'cui_str': 'Thread'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0026196', 'cui_str': 'Minoxidil'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}]",27.0,0.0389189,"RESULTS


Mean hair density increased from 114 ± 27 to 143 ± 25/cm 2  (P < .001) in the combined group and from 113 ± 24 to 123 ± 19/cm 2  in the minoxidil group (P < .001).","[{'ForeName': 'Fathia M', 'Initials': 'FM', 'LastName': 'Khattab', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Hagar', 'Initials': 'H', 'LastName': 'Bessar', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13228']
1189,20697842,Long-term response with everolimus for metastatic renal cell carcinoma refractory to sunitinib.,"A 70-year-old man with metastatic renal cell carcinoma developed progressive liver metastases after 8 weeks of treatment with the multitargeted tyrosine kinase inhibitor (TKI) sunitinib. He then participated in the phase III placebo-controlled clinical trial of the oral mammalian target of rapamycin (mTOR) inhibitor everolimus, initially randomized to placebo (but had disease progression after 3 months) and crossed over to everolimus at time of unblinding. The patient had stable disease after 8 weeks (two cycles) of everolimus that was maintained until 28 months of therapy, at which time the patient had achieved a partial response. This case illustrates the potential for patients with metastatic renal cell carcinoma, a malignancy with historically poor prognosis, to derive long-term benefit from everolimus when used in a manner consistent with its approved indication (after TKI therapy with sunitinib or sorafenib).",2011,A 70-year-old man with metastatic renal cell carcinoma developed progressive liver metastases after 8 weeks of treatment with the multitargeted tyrosine kinase inhibitor (TKI) sunitinib.,"['patients with metastatic renal cell carcinoma, a malignancy with historically poor prognosis', 'A 70-year-old man with metastatic renal cell carcinoma', 'metastatic renal cell carcinoma refractory to sunitinib']","['everolimus', 'placebo', 'rapamycin (mTOR) inhibitor everolimus', 'sunitinib or sorafenib', 'multitargeted tyrosine kinase inhibitor (TKI) sunitinib']","['partial response', 'progressive liver metastases']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0278252', 'cui_str': 'Prognosis bad (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0033681', 'cui_str': 'Tyrosylprotein Kinase'}]","[{'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",,0.0572666,A 70-year-old man with metastatic renal cell carcinoma developed progressive liver metastases after 8 weeks of treatment with the multitargeted tyrosine kinase inhibitor (TKI) sunitinib.,"[{'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Molina', 'Affiliation': 'Genitourinary Service, Division of Medical Oncology and the Department of Medical Imaging, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Ginsberg', 'Affiliation': ''}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': ''}]","Medical oncology (Northwood, London, England)",['10.1007/s12032-010-9640-y']
1190,31213227,Effects of word overlap on generalized gains from a repeated readings intervention.,"We compared children's gains in oral reading fluency after applying a standard fluency-building intervention to three training passages that differed in word overlap (high, low, and multiple exemplar) with an untrained generalization passage. Participants were 132 White and Hispanic third-grade children from two schools in the northeast and mountain west. Children were randomly assigned within classrooms to the three word overlap conditions, pre-tested on their assigned training and a common generalization passage, received a fluency-building intervention on their assigned training passage, and then post-tested on the same two passages. Regression analyses were conducted to examine the effects of word overlap condition on the children's fluency gains after controlling for pre-test fluency and classroom. Results revealed significantly larger priming and generalization effects for the multiple exemplar versus both the low- and high-word overlap conditions. Survival curves showed that a significantly larger proportion of children in the multiple exemplar condition survived as generalized responders at all generalization levels relative to the other two conditions. Implications for assessing and promoting generalized oral reading fluency in response-to-intervention models and directions for future research are discussed.",2019,Results revealed significantly larger priming and generalization effects for the multiple exemplar versus both the low- and high-word overlap conditions.,['Participants were 132 White and Hispanic third-grade children from two schools in the northeast and mountain west'],"['three word overlap conditions, pre-tested on their assigned training and a common generalization passage, received a fluency-building intervention']","['larger priming and generalization effects', 'generalized gains', 'Survival curves']","[{'cui': 'C1097368', 'cui_str': 'AM132'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0442533', 'cui_str': 'Mountain (environment)'}]","[{'cui': 'C0185027', 'cui_str': 'Imbrication (procedure)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0017324', 'cui_str': 'Generalization'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0017324', 'cui_str': 'Generalization'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",132.0,0.0148976,Results revealed significantly larger priming and generalization effects for the multiple exemplar versus both the low- and high-word overlap conditions.,"[{'ForeName': 'Brian K', 'Initials': 'BK', 'LastName': 'Martens', 'Affiliation': 'Syracuse University, United States of America. Electronic address: bkmarten@syr.edu.'}, {'ForeName': 'Nicholas D', 'Initials': 'ND', 'LastName': 'Young', 'Affiliation': ""Medical College of Wisconsin and Children's Hospital of Wisconsin, United States of America.""}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Mullane', 'Affiliation': 'Syracuse University, United States of America.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Baxter', 'Affiliation': 'Syracuse University, United States of America.'}, {'ForeName': 'Samantha J', 'Initials': 'SJ', 'LastName': 'Sallade', 'Affiliation': 'Syracuse University, United States of America.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kellen', 'Affiliation': 'Syracuse University, United States of America.'}, {'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Long', 'Affiliation': 'Syracuse University, United States of America.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Sullivan', 'Affiliation': 'Syracuse University, United States of America.'}, {'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Womack', 'Affiliation': 'Syracuse University, United States of America.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Underberg', 'Affiliation': 'Syracuse University, United States of America.'}]",Journal of school psychology,['10.1016/j.jsp.2019.05.002']
1191,31867715,Carbetocin at elective caesarean section: a sequential allocation trial to determine the minimum effective dose in obese women.,"Postpartum haemorrhage is a leading cause of maternal death during childbirth. There is an increasing incidence of atonic postpartum haemorrhage in developed countries, and maternal obesity has been proposed as a contributing factor. The dose-response relationship of carbetocin in obese women has not yet been determined. We conducted a double-blind, dose-finding study of carbetocin using a biased coin up-and-down design in women with a body mass index ≥ 40 kg.m -2  undergoing elective caesarean section. The determinant for a successful response was satisfactory uterine tone, with no intra-operative need for additional uterotonic drugs. Secondary outcomes included the use of additional uterotonic drugs postoperatively, estimated blood loss and adverse effects of carbetocin administration. Thirty women were recruited to the study. The median (IQR [range]) body mass index was 44.93 (41.5-55.2 [40-66.5]) kg.m -2  . The ED 90  of carbetocin was estimated as 62.9 (95%CI 57.0-68.7) μg using the truncated Dixon and Mood method, and 68 (95%CI 52-77) μg using the isotonic regression method. The estimated blood loss was 880 (621-1178 [75-2442]) ml. The overall rates of hypotension and hypertension after delivery were 40% and 6.7%, respectively, while nausea occurred in 26.7% of women. The ED 90  for carbetocin in obese women at elective caesarean section is lower than the dose of 100 μg currently recommended by the Society of Obstetricians and Gynaecologists of Canada, but is approximately four times higher than the previously demonstrated ED 90  of 14.8 μg in women with body mass index < 40 kg.m -2  .",2020,"Secondary outcomes included the use of additional uterotonic drugs postoperatively, estimated blood loss and adverse effects of carbetocin administration.","['obese women at elective caesarean section', '40', 'kg.m -2  undergoing elective caesarean section', 'women with a body mass index ≥', 'Carbetocin at elective caesarean section', 'obese women', 'Thirty women were recruited to the study']",['carbetocin'],"['estimated blood loss', 'nausea', 'use of additional uterotonic drugs postoperatively, estimated blood loss and adverse effects of carbetocin administration', 'overall rates of hypotension and hypertension after delivery', 'median (IQR [range]) body mass index']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0054670', 'cui_str': 'oxytocin, 1-desamino-1-monocarba-(tyrosine(O-methyl))(2)-'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0054670', 'cui_str': 'oxytocin, 1-desamino-1-monocarba-(tyrosine(O-methyl))(2)-'}]","[{'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C3653843', 'cui_str': 'Other uterotonics in ATC'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0054670', 'cui_str': 'oxytocin, 1-desamino-1-monocarba-(tyrosine(O-methyl))(2)-'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",30.0,0.442657,"Secondary outcomes included the use of additional uterotonic drugs postoperatively, estimated blood loss and adverse effects of carbetocin administration.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Drew', 'Affiliation': 'Maternal and Infant Care Research Center, University of Toronto, ON, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Balki', 'Affiliation': 'Maternal and Infant Care Research Center, University of Toronto, ON, Canada.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Farine', 'Affiliation': 'Maternal and Infant Care Research Center, University of Toronto, ON, Canada.'}, {'ForeName': 'X Y', 'Initials': 'XY', 'LastName': 'Ye', 'Affiliation': 'Maternal and Infant Care Research Center, University of Toronto, ON, Canada.'}, {'ForeName': 'J C A', 'Initials': 'JCA', 'LastName': 'Carvalho', 'Affiliation': 'Mount Sinai Hospital, University of Toronto, ON, Canada.'}]",Anaesthesia,['10.1111/anae.14944']
1192,31204284,"Telemonitoring-supported exercise training, metabolic syndrome severity, and work ability in company employees: a randomised controlled trial.","BACKGROUND


Metabolic syndrome is a predisposing factor for cardiovascular and metabolic disease, but also has socioeconomic relevance by affecting the health and productivity of workers. We tested the effect of regular telemonitoring-supported physical activity on metabolic syndrome severity and work ability in company employees.
METHODS


This was a prospective, randomised, parallel-group, and assessor-blind study done in workers in the main Volkswagen factory (Wolfsburg, Germany). Volunteers with diagnosed metabolic syndrome according to American Heart Association/National Heart, Lung, and Blood Institute criteria were randomly assigned (1:1) to a 6-month lifestyle intervention focusing on regular exercise (exercise group), or to a waiting-list control group, using a computer-based assignment list with variable block length. Participants in the exercise group received individual recommendations for exercise at face-to-face meetings and via a smartphone application, with the aim of doing 150 min physical activity per week. Activities were supervised and adapted using activity-monitor data, which were transferred to a central database. Participants in the control group continued their current lifestyle and were informed about the possibility to receive the supervised intervention after study completion. The primary outcome was the change in metabolic syndrome severity (metabolic syndrome Z score) after 6 months in the intention-to treat population. This trial is registered with ClinicalTrials.gov, number NCT03293264, and is closed to new participants.
FINDINGS


543 individuals were screened between Oct 10, 2017, and Feb 27, 2018, of whom 314 (mean age 48 years [SD 8]) were randomly assigned to receive the intervention (n=160; exercise group) or to a waiting list (n=154; control group). The mean metabolic syndrome Z score for the exercise group was significantly reduced after the 6-month intervention period (0·93 [SD 0·63] before and 0·63 [0·64] after the intervention) compared with the control group (0·95 [0·55] and 0·90 [0·61]; difference between groups -0·26 [95% CI -0·35 to -0·16], p<0·0001). We documented 11 adverse events in the exercise group, with only one event (a twisted ankle) regarded as directly caused by the intervention.
INTERPRETATION


A 6-month exercise-focused intervention using telemonitoring systems reduced metabolic syndrome severity. This form of intervention shows significant potential to reduce disease risk, while also improving mental health, work ability, and productivity-related outcomes for employees at high risk for cardiovascular and metabolic disease.
FUNDING


Audi BKK health insurance and the German Research Foundation through the Cluster of Excellence REBIRTH.",2019,"This form of intervention shows significant potential to reduce disease risk, while also improving mental health, work ability, and productivity-related outcomes for employees at high risk for cardiovascular and metabolic disease.
","['543 individuals were screened between Oct 10, 2017, and Feb 27, 2018, of whom 314 (mean age 48 years [SD 8', 'Volunteers with diagnosed metabolic syndrome according to American Heart Association/National Heart, Lung, and Blood Institute criteria', 'company employees', 'workers in the main Volkswagen factory (Wolfsburg, Germany']","['intervention (n=160; exercise group) or to a waiting list', 'lifestyle intervention focusing on regular exercise (exercise group), or to a waiting-list control group, using a computer-based assignment list with variable block length', 'regular telemonitoring-supported physical activity', 'Telemonitoring-supported exercise training', 'individual recommendations for exercise at face-to-face meetings and via a smartphone application']","['change in metabolic syndrome severity (metabolic syndrome Z score', 'mean metabolic syndrome Z score', 'metabolic syndrome severity', 'mental health, work ability, and productivity-related outcomes']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0002458', 'cui_str': 'American Heart Association'}, {'cui': 'C1955970', 'cui_str': 'National Heart, Lung, and Blood Institute'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0442614', 'cui_str': 'Factory (environment)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise (observable entity)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",543.0,0.10718,"This form of intervention shows significant potential to reduce disease risk, while also improving mental health, work ability, and productivity-related outcomes for employees at high risk for cardiovascular and metabolic disease.
","[{'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Haufe', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Hannover, Germany. Electronic address: haufe.sven@mh-hannover.de.'}, {'ForeName': 'Arno', 'Initials': 'A', 'LastName': 'Kerling', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Protte', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Bayerle', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Hedwig T', 'Initials': 'HT', 'LastName': 'Stenner', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Rolff', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Thorben', 'Initials': 'T', 'LastName': 'Sundermeier', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Momme', 'Initials': 'M', 'LastName': 'Kück', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Ensslen', 'Affiliation': 'Volkswagen AG, Wolfsburg, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Nachbar', 'Affiliation': 'Volkswagen AG, Wolfsburg, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Lauenstein', 'Affiliation': 'Audi BKK Health Insurance, Ingolstadt, Germany.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Böthig', 'Affiliation': 'Department of Cardiac, Thoracic, Transplantation, and Vascular Surgery, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Bara', 'Affiliation': 'Department of Cardiac, Thoracic, Transplantation, and Vascular Surgery, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Hanke', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Terkamp', 'Affiliation': 'Department of Gastroenterology, Hepatology, and Endocrinology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Meike', 'Initials': 'M', 'LastName': 'Stiesch', 'Affiliation': 'Department of Prosthetic Dentistry and Biomedical Materials Science, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Hilfiker-Kleiner', 'Affiliation': 'Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Haverich', 'Affiliation': 'Department of Cardiac, Thoracic, Transplantation, and Vascular Surgery, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Tegtbur', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Hannover, Germany.'}]",The Lancet. Public health,['10.1016/S2468-2667(19)30075-1']
1193,31775839,Efficacy of verum and sham acupoint catgut embedding for treatment of obesity: Study protocol for a randomized controlled trial.,"BACKGROUND


Obesity has become a major public health hazard with epidemic proportions, affecting adults, adolescents, and children of both genders. Previous studies have suggested that acupoint catgut embedding (ACE) might be a potential therapeutic approach for obesity. The purpose of this study is to conduct a rigorous and normative trial to determine the efficacy of ACE for obesity.
METHODS/DESIGN


A total of 99 eligible patients diagnosed with obesity will be recruited in this study. They will be randomly allocated to either the verum ACE group, sham ACE group, or waiting list (WL) group, with 33 patients in each group. Each patient in the two ACE-based groups will receive eight sessions of treatment, lasting over 8 weeks. The primary outcome is the reduction of body mass index (BMI) after treatment. Secondary outcomes will include waist circumference (WC), hip circumference (HC), waist:hip ratio, body fat percentage, blood lipid level, subcutaneous fat area, visceral fat area, and World Health Organization Quality of Life (WHOQOL). All the outcomes will be evaluated at baseline, at the end of the 8 weeks of treatments, and at 3 months of follow-up. The evaluators and data analyzers will be blinded to group allocation.
DISCUSSION


The findings of this randomized, sham-, and WL-controlled trial will help to investigate the influence of ACE on clinical variables as well as visceral fat area of obesity, which will provide high-quality evidence on the efficacy of ACE for obesity.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR1800020248. Registered on December 21, 2018.",2019,"They will be randomly allocated to either the verum ACE group, sham ACE group, or waiting list (WL) group, with 33 patients in each group.",['99 eligible patients diagnosed with obesity will be recruited in this study'],"['verum ACE', 'acupoint catgut embedding (ACE', 'ACE', 'sham ACE group, or waiting list (WL', 'verum and sham acupoint catgut embedding']","['reduction of body mass index (BMI', 'waist circumference (WC), hip circumference (HC), waist:hip ratio, body fat percentage, blood lipid level, subcutaneous fat area, visceral fat area, and World Health Organization Quality of Life (WHOQOL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0067453', 'cui_str': 'N-(2-acetamido)-2-aminoethanesulfonic acid'}, {'cui': 'C0001302', 'cui_str': 'Acupoints'}, {'cui': 'C0007420', 'cui_str': 'Catgut'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference (observable entity)'}, {'cui': 'C0230097', 'cui_str': 'Waist (surface region)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0005768'}, {'cui': 'C0428460', 'cui_str': 'Finding of lipid level (finding)'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0034380'}]",99.0,0.162625,"They will be randomly allocated to either the verum ACE group, sham ACE group, or waiting list (WL) group, with 33 patients in each group.","[{'ForeName': 'Yu-Mei', 'Initials': 'YM', 'LastName': 'Zhou', 'Affiliation': 'The Fourth Clinical Medical College of Guangzhou University of Chinese Medicine, Shenzhen, 518033, GuangDong, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Yan', 'Affiliation': 'The Fourth Clinical Medical College of Guangzhou University of Chinese Medicine, Shenzhen, 518033, GuangDong, China.'}, {'ForeName': 'Wei-Qu', 'Initials': 'WQ', 'LastName': 'Yuan', 'Affiliation': 'The Fourth Clinical Medical College of Guangzhou University of Chinese Medicine, Shenzhen, 518033, GuangDong, China.'}, {'ForeName': 'Hai-Bo', 'Initials': 'HB', 'LastName': 'Yu', 'Affiliation': 'The Fourth Clinical Medical College of Guangzhou University of Chinese Medicine, Shenzhen, 518033, GuangDong, China.'}, {'ForeName': 'Zhuo-Xin', 'Initials': 'ZX', 'LastName': 'Yang', 'Affiliation': 'The Fourth Clinical Medical College of Guangzhou University of Chinese Medicine, Shenzhen, 518033, GuangDong, China. 001188@gzucm.edu.cn.'}]",Trials,['10.1186/s13063-019-3730-8']
1194,31775843,"Effects of the Chinese herbal formula San-Huang Gu-Ben Zhi-Ke treatment on stable chronic obstructive pulmonary disease: study protocol of a randomized, double-blind, placebo-controlled trial.","BACKGROUND


Due to the large number of patients, high mortality rate as well as high social costs and economic burden, chronic obstructive pulmonary disease (COPD) has become one of the most important health problems around the world, which has attracted people's attention. Currently, Chinese herbs have been widely used as alternative medicine (CAM) for COPD patients. The Chinese herbal formula San-Huang Gu-Ben Zhi-Ke (SHGBZK) has shown good clinical efficacy in COPD in preclinical studies. Animal experiments have shown that it has mucosal immune barrier function and can maintain airway wall integrity, reduce inflammatory cell infiltration, promote inflammatory damage repair, and relieve narrow airway conditions.
METHODS/DESIGN


This study is a randomized, double-blind, placebo-controlled trial. A total of 100 patients with stable COPD diagnosed with deficiency of lung qi and spleen qi will be recruited and randomly assigned to one of two treatment groups: SHGBZK treatment, N = 50; placebo treatment, N = 50. The two groups will receive basic treatment for COPD according to the 2017 GOLD Guidelines for Chronic Obstructive Pulmonary Disease. Patients will stick to the treatment they used to take as much as possible, and will be given present general treatment when acute exacerbation of COPD occurs during the study. Both groups will receive a 24-week intervention and patient status will be assessed at 24 weeks and then 28 weeks after treatment. After the 24-week treatment, patients will be followed up for another 28 weeks. Outcome measures, including the frequency and duration of acute exacerbation, lung function, traditional Chinese medicine symptom score, exercise capacity, and quality of life will be assessed.
DISCUSSION


It is hypothesized that SHGBZK will have beneficial effects in reducing the frequency and duration of acute exacerbations, improving the exercise capacity function of patients with stable COPD diagnosed with a deficiencies in lung qi and spleen qi. This study may establish a new treatment method for COPD patients, differentiating it from other drugs in clinical use used for similar clinical indications.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR1800016349. Registered on 26 May 2018.",2019,"Outcome measures, including the frequency and duration of acute exacerbation, lung function, traditional Chinese medicine symptom score, exercise capacity, and quality of life will be assessed.
","['COPD patients', '100 patients with stable COPD diagnosed with deficiency of lung qi and spleen qi', 'patients with stable COPD diagnosed with a deficiencies in lung qi and spleen qi', 'stable chronic obstructive pulmonary disease']","['Chinese herbal formula San-Huang Gu-Ben Zhi-Ke (SHGBZK', 'placebo', 'SHGBZK', 'Chinese herbal formula San-Huang Gu-Ben Zhi-Ke treatment', 'SHGBZK treatment, N\xa0=\u200950; placebo treatment, N\u2009=\u200950']","['frequency and duration of acute exacerbation, lung function, traditional Chinese medicine symptom score, exercise capacity, and quality of life will be assessed']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0037993', 'cui_str': 'Spleen'}]","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0376667', 'cui_str': 'Herbal'}, {'cui': 'C3885803', 'cui_str': 'San-Huang'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0025124', 'cui_str': 'Zhong Yi Xue'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034380'}]",100.0,0.330996,"Outcome measures, including the frequency and duration of acute exacerbation, lung function, traditional Chinese medicine symptom score, exercise capacity, and quality of life will be assessed.
","[{'ForeName': 'Yaqi', 'Initials': 'Y', 'LastName': 'Zu', 'Affiliation': ""Beijing University of Chinese Medicine, Chao Yang District, Beijing, 100029, People's Republic of China.""}, {'ForeName': 'Demin', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Respiratory Department of Traditional Chinese Medicine, China-Japan Friendship Hospital, 2 Cherry Garden East Street, Chaoyang District, Beijing, 100029, China. deminli2008@sina.com.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Lei', 'Affiliation': 'Beijing Qihuang Pharmaceutical Clinical Research Center, Feng Tai District, Beijing, China.'}, {'ForeName': 'Hongchun', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Chinese Medicine Office, China-Japan Friendship Hospital, 2 Cherry Garden East Street, Chaoyang District, Beijing, 100029, China. hongchunzhang@tom.com.'}]",Trials,['10.1186/s13063-019-3729-1']
1195,31775854,"Influence of volatile anesthesia versus total intravenous anesthesia on chronic postsurgical pain after cardiac surgery using the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials criteria: study protocol for a prospective randomized controlled trial.","BACKGROUND


Many patients develop chronic postsurgical pain (CPSP) after cardiac surgery, which interferes with their sleep, mood, and quality of life. Studies have suggested that propofol improves postoperative analgesia compared with volatile anesthetics, but its preventive effect on CPSP following cardiac surgery is still unknown. This study compares the incidence of CPSP following cardiac surgery for those receiving volatile anesthesia and those receiving propofol-based total intravenous anesthesia (TIVA) using criteria recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT).
METHODS/DESIGN


This is a prospective randomized controlled trial. In total, 500 adults undergoing cardiac surgery will be randomly allocated to the volatile or the TIVA group. The volatile group will receive sevoflurane or desflurane during surgery as general anesthesia. The TIVA group will receive propofol-based intravenous agents and no volatile agents during surgery. The primary outcomes will be the frequency of CPSP at 3 months, 6 months, and 1 year after surgery. In this case, CPSP is sternal or thoracic pain. It is defined as either (1) numerical rating scale (NRS) > 0 or (2) meeting all six IMMPACT criteria for CPSP. The IMMPACT criteria are validated pain instruments.
DISCUSSION


To our knowledge, this is the first prospective randomized controlled trial to investigate the prevention of CPSP following cardiac surgery for patients receiving volatile anesthesia compared to those receiving propofol-based TIVA using validated pain instruments in accordance with the IMMPACT recommendations. This study will provide important information on which of these two anesthetic regimens is better for preventing CPSP after cardiac surgery.
TRIAL REGISTRATION


Chictr.org.cn, ChiCTR1900020747. Registered on 16 January 2019.",2019,"To our knowledge, this is the first prospective randomized controlled trial to investigate the prevention of CPSP following cardiac surgery for patients receiving volatile anesthesia compared to those receiving propofol-based TIVA using validated pain instruments in accordance with the IMMPACT recommendations.","['patients develop chronic postsurgical pain (CPSP) after cardiac surgery', '500 adults undergoing cardiac surgery', 'patients receiving volatile anesthesia compared to those receiving propofol-based TIVA using validated pain instruments in accordance with the IMMPACT recommendations']","['propofol-based total intravenous anesthesia (TIVA', 'volatile anesthesia versus total intravenous anesthesia', 'propofol-based intravenous agents and no volatile agents', 'CPSP', 'propofol', 'volatile anesthesia', 'sevoflurane or desflurane']","['frequency of CPSP', 'postoperative analgesia', 'chronic postsurgical pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1963547', 'cui_str': 'Volatile'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3854651', 'cui_str': 'TIVA'}, {'cui': 'C4551823', 'cui_str': 'instruments'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia (procedure)'}, {'cui': 'C3854651', 'cui_str': 'TIVA'}, {'cui': 'C1963547', 'cui_str': 'Volatile'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0443769', 'cui_str': 'Volatile agent'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",500.0,0.0800677,"To our knowledge, this is the first prospective randomized controlled trial to investigate the prevention of CPSP following cardiac surgery for patients receiving volatile anesthesia compared to those receiving propofol-based TIVA using validated pain instruments in accordance with the IMMPACT recommendations.","[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': ""Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Jian-Qiao', 'Initials': 'JQ', 'LastName': 'Zheng', 'Affiliation': ""Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Yu-Si', 'Initials': 'YS', 'LastName': 'Hua', 'Affiliation': ""Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Shuo-Fang', 'Initials': 'SF', 'LastName': 'Ren', 'Affiliation': ""Department of Cardiovascular surgery, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': ""Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu, 610041, People's Republic of China. yuhaishan117@yahoo.com.""}]",Trials,['10.1186/s13063-019-3742-4']
1196,31387756,Hyperthermic intraperitoneal chemotherapy in serosa-invasive gastric cancer patients.,"BACKGROUND


Evaluation of hyperthermic intraperitoneal chemotherapy (HIPEC) in reducing metachronous peritoneal metastases (MPM) risks in patients with resectable serosa-invasive gastric cancer.
MATERIALS & METHODS


Between 2008 and 2016, 154 patients with gastric cancer (stage IIB-IIIC) were randomly assigned to two groups: 76 patients underwent HIPEC (cisplatin 50 mg/m 2  + doxorubicin 50 mg/m 2 , 42 °C, 1 h) combined with radical surgery (HIPEC group) and 78 patients underwent only radical surgery (control group).
RESULTS


Evaluation of HIPEC toxicity showed neither toxic complications of IV-V degree nor haematological toxicity (according to CTCAE v. 4.03). There was no significant difference in the rate of complications between the two groups (p = 0.254). There was a more frequent disease progression in the control group than in the HIPEC group: 42/55 patients (76.4%) vs. 36/68 patients (52.9%), respectively (p = 0.009). At the same time a significant decrease in the rate of MPM was observed after HIPEC administration as compared with surgery alone - 16/68 (12.8%) vs. 39/55 (27.6%) (p < 0.001). 3-year progression-free survival was 47% (95% CI 36-61)) in the HIPEC group and 27% (95% CI 17-43) in the control group - p = 0.0024. The N-stage, HIPEC procedure, type of surgery and interaction between HIPEC treatment and age were independent prognostic factors.
CONCLUSIONS


HIPEC appears to be helpful in improving treatment results in radically operated gastric cancer patients.",2019,3-year progression-free survival was 47% (95% CI 36-61)) in the HIPEC group and 27% (95% CI 17-43) in the control group - p = 0.0024.,"['Between 2008 and 2016', 'patients with resectable serosa-invasive gastric cancer', 'radically operated gastric cancer patients', '154 patients with gastric cancer (stage IIB-IIIC', 'serosa-invasive gastric cancer patients']","['Hyperthermic intraperitoneal chemotherapy', '\xa0doxorubicin 50', 'HIPEC', 'radical surgery (HIPEC group) and 78 patients underwent only radical surgery (control group', 'hyperthermic intraperitoneal chemotherapy (HIPEC', 'HIPEC (cisplatin 50']","['rate of complications', 'frequent disease progression', '3-year progression-free survival', 'toxic complications of IV-V degree nor haematological toxicity', 'rate of MPM']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036760', 'cui_str': 'Serosa'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0441769', 'cui_str': 'Stage 2B (qualifier value)'}]","[{'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1742123', 'cui_str': '(11C)MPM'}]",154.0,0.0363659,3-year progression-free survival was 47% (95% CI 36-61)) in the HIPEC group and 27% (95% CI 17-43) in the control group - p = 0.0024.,"[{'ForeName': 'M Yu', 'Initials': 'MY', 'LastName': 'Reutovich', 'Affiliation': 'Gastroesophageal Pathology Departement, N.N. Alexandrov National Cancer Center, Minsk, Belarus. Electronic address: mihail_revtovich@yahoo.com.'}, {'ForeName': 'O V', 'Initials': 'OV', 'LastName': 'Krasko', 'Affiliation': 'United Institute of Informatics Problems, National Academy of Sciences, Minsk, Belarus.'}, {'ForeName': 'O G', 'Initials': 'OG', 'LastName': 'Sukonko', 'Affiliation': 'Gastroesophageal Pathology Departement, N.N. Alexandrov National Cancer Center, Minsk, Belarus.'}]",European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology,['10.1016/j.ejso.2019.07.030']
1197,31774376,Influence of Foot-Landing Positions at Initial Contact on Knee Flexion Angles for Single-Leg Drop Landings.,"Purpose : Small knee flexion angles are associated with increased non-contact anterior cruciate ligament (ACL) injury risks. The purpose of this study was to provide insights into how ankle plantar flexion angles influenced knee flexion angles at initial contact during single-leg drop landings.  Method : Thirteen male recreational basketball players performed single-leg drop landings from a 30-cm high platform using three randomized foot-landing positions (natural, fore-foot, and flat-foot). A motion capture system and a force plate were used to measure lower extremity kinematics and vertical ground reaction force (VGRF). A one-way repeated measures Analysis of Variance and the Friedman test were conducted (α = .05).  Results : Foot-landing position had a significant effect on knee flexion angles at initial contact ( p  < .001). As compared to flat-foot landings (18° ( SD  5°), significantly smaller knee flexion angles were found for natural (mean 12° ( SD  5°),  p  = .004) and fore-foot landings (mean 12° ( SD  3°),  p  = .001). There was however significantly smaller knee flexion range of motion in flat-foot landings (mean 42° ( SD  3°), as compared to natural landings (mean 48° ( SD  4°) ( p  < .001). Flat-foot landings also resulted in a 1.4 times higher maximum VGRF than fore-foot landings ( p  < .001) and 1.3 times higher than natural landings ( p  = .005).  Conclusions : Natural and fore-foot landings are better for force absorption but are associated with smaller knee flexion angles at initial contact. These findings have important implications for non-contact ACL injuries.",2020,Natural and fore-foot landings are better for force absorption but are associated with smaller knee flexion angles at initial contact.,"['Single-leg Drop Landings', 'Thirteen male recreational basketball players']",[],"['knee flexion angles', 'extremity kinematics and vertical ground reaction force (VGRF', 'smaller knee flexion range of motion in flat-foot landings', 'fore-foot landings', 'smaller knee flexion angles']","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0557668', 'cui_str': 'Landing (environment)'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}]",[],"[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0016202', 'cui_str': 'Splayfoot'}, {'cui': 'C0557668', 'cui_str': 'Landing (environment)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}]",13.0,0.0199017,Natural and fore-foot landings are better for force absorption but are associated with smaller knee flexion angles at initial contact.,"[{'ForeName': 'Phillis Soek Po', 'Initials': 'PSP', 'LastName': 'Teng', 'Affiliation': 'Nanyang Technological University.'}, {'ForeName': 'Kah Fai', 'Initials': 'KF', 'LastName': 'Leong', 'Affiliation': 'Nanyang Technological University.'}, {'ForeName': 'Pui Wah', 'Initials': 'PW', 'LastName': 'Kong', 'Affiliation': 'Nanyang Technological University.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2019.1669765']
1198,31774380,Seeing Is Believing: Blind Putting Drills Confer No Advantage to the Novice Golfer.,"Purpose : Golf coaches may recommend ""blind"" putting drills in which golfers close their eyes to improve their feel. Research on specificity of learning suggests, however, that adding or removing a source of sensory information after practicing under differing circumstances can cause performance decrements. Specificity of learning is also dependent upon specific task requirements. The purpose of this study was to examine whether golf putting, requiring body positioning and aiming an implement, would benefit from blind training.  Method : Novice golfers (n = 24) in Vision Training (VT) & No-Vision Training (NVT) groups completed 108 trials of a 10-ft putt. After a 24-hr delay, both groups completed sighted- and blind-putting tests.  Results : Acquisition results revealed Group × Block interactions in RE ( p  = .025) and y-VE ( p  = .032). Post hoc procedures revealed significant differences between the groups on Block 2 ( p  = .017), with the NVT group producing longer mean RE. During testing, RE and x-VE results revealed Group × Test interactions ( p  = .027 & .041), such that performance of the VT group suffered when transferred to blind putting, while performance of the NVT group did not differ when transferred.  Conclusion : NVT did not confer any advantage for subsequent performance with vision. Moreover, results were not consistent with the specificity of learning hypothesis and suggest that putting does not rely on complete sensory integration to support subsequent performance. Presumably, task requirements related to body positioning provided adequate sensory cues for successful performance.",2020,Acquisition results revealed Group × Block interactions in RE ( p  = .025) and y-VE ( p  = .032).,[],"['Vision Training (VT) ', 'NVT', 'No-Vision Training (NVT']",[],[],"[{'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]",[],,0.0352187,Acquisition results revealed Group × Block interactions in RE ( p  = .025) and y-VE ( p  = .032).,"[{'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Fisher', 'Affiliation': 'Central Michigan University.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Fairbrother', 'Affiliation': 'University of Tennessee.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2019.1674443']
1199,31774382,Can the Stereotype Threat and Lift Phenomenon Be Applicable to a Muscular Endurance Task?,"Purpose . Inducing a negative stereotype toward women usually leads to a decrease in women performance and an increase in men performance. These effects were observed during technical tasks. The purpose of the present study was to investigate the effect of this sex stereotype during a non-technical muscular endurance task. The perception of effort, closely related to endurance performance, was also recorded. Based on the type of task and the mere effort account, we predicted that both men and women in the negative stereotype toward women condition would perform better than participants in the two other groups.  Method . Seventy-seven participants (38 women and 39 men) were randomly assigned to a negative stereotype toward women, a nullified-stereotype, or a control condition. Then, they performed a submaximal handgrip task until exhaustion at 50% of their maximal strength.  Results . This study showed that performance at T2 was reduced for men and women in the nullified-stereotype and control conditions, but not in the negative stereotype toward women condition, revealing that participants in the negative stereotype toward women condition performed better than participants in the other conditions. No significant difference was observed concerning the perception of effort according to the conditions.  Conclusion . As compared to technical tasks, inducing a negative stereotype toward women increased women's performance. The perception of effort could be responsible for this performance improvement. However, more research is needed to investigate the mechanisms involved. Concerning men, in line with the stereotype lift phenomenon, a performance increase was observed in this same condition.",2020,"This study showed that performance at T2 was reduced for men and women in the nullified-stereotype and control conditions, but not in the negative stereotype toward women condition, revealing that participants in the negative stereotype toward women condition performed better than participants in the other conditions.",['Seventy-seven participants (38 women and 39 men'],"['negative stereotype toward women, a nullified-stereotype, or a control condition', 'sex stereotype during a non-technical muscular endurance task']",['men performance'],"[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0038272', 'cui_str': 'Stereotyping'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}]",77.0,0.0306224,"This study showed that performance at T2 was reduced for men and women in the nullified-stereotype and control conditions, but not in the negative stereotype toward women condition, revealing that participants in the negative stereotype toward women condition performed better than participants in the other conditions.","[{'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Deshayes', 'Affiliation': ""Université Côte d'Azur.""}, {'ForeName': 'Raphaël', 'Initials': 'R', 'LastName': 'Zory', 'Affiliation': ""Université Côte d'Azur.""}, {'ForeName': 'Allison E', 'Initials': 'AE', 'LastName': 'Seitchik', 'Affiliation': 'Merrimack College.'}, {'ForeName': 'Aïna', 'Initials': 'A', 'LastName': 'Chalabaev', 'Affiliation': 'Université Grenoble Alpes.'}, {'ForeName': 'Corentin', 'Initials': 'C', 'LastName': 'Clément-Guillotin', 'Affiliation': ""Université Côte d'Azur.""}]",Research quarterly for exercise and sport,['10.1080/02701367.2019.1668518']
1200,31227804,Fatty acid regio-specificity of triacylglycerol molecules may affect plasma lipid responses to dietary fats-a randomised controlled cross-over trial.,"BACKGROUND/OBJECTIVES


Hypercholesterolaemic effects of saturated fatty acids (SFA) may be influenced not only by the chain length, but also by their specific location within the triacylglycerol (TAG) molecule. We examined the hypothesis that dietary fats rich in SFA, but containing mostly unsaturated fatty acids in the sn-2 position with most SFA in sn-1 and -3 (palm olein [PO] and cocoa butter [CB]) will have similar serum lipid outcomes to unsaturated olive oil (OO).
SUBJECTS/METHODS


Thirty-eight participants (20-40 yr, 18.5- ≤ 27.5 kg/m 2 ) completed a 4-week randomised 3 × 3 crossover feeding intervention, preceded by 2-week run-in and separated by 2-week washout periods. Background diet contained 35 percentage of total energy (%E) fat, 18%E protein, 48%E carbohydrates, differing in test fats only (palm olein (PO), CB, OO; 20%E). Total cholesterol (TC)/high density lipoprotein cholesterol (HDL-C) ratio and related variables; TC, HDL-C, low density lipoprotein cholesterol (LDL-C), TAG, apoA1, ApoB, ApoA1 (apolipoprotein A1)/ApoB (apolipoprotein B), lipoprotein (a) (Lp(a)), NEFA, LDL sub-fractions, were assessed pre- and post-intervention. Data were analysed using mixed effects longitudinal models with a P-value < 0.05 considered significant.
RESULTS


Changes in plasma fatty acids (P < 0.05) confirmed compliance; C18:1 increased with OO compared to PO and CB; C16:0 decreased with OO and C18:0 increased following CB. No differences were seen for TC/HDL-C (mean [95%CI] change for PO, 0.08[0.00, 0.15] mmol/L; CB, 0.06 [-0.05, 0.16] mmol/L; and OO, -0.01 [-0.15, 0.13] mmol/L; P = 0.53] or any other parameter including LDL sub-fractions. OO decreased IDL-A compared to PO (-2.2 [-4.31, -0.21] mg/dL, P = 0.03).
CONCLUSION


In healthy young participants, plasma lipid responses to PO and CB, enriched in SFA but having primarily unsaturated fatty acid in the sn-2 position of TAG, did not differ from OO.",2020,"RESULTS


Changes in plasma fatty acids (P < 0.05) confirmed compliance; C18:1 increased with OO compared to PO and CB; C16:0 decreased with OO and C18:0 increased following CB.","['Thirty-eight participants (20-40\u2009yr, 18.5-\u2009≤\u200927.5', 'healthy young participants']",['saturated fatty acids (SFA'],"['plasma fatty acids', 'plasma lipid responses', 'TC/HDL-C', 'OO and C18:0', 'Total cholesterol (TC)/high density lipoprotein cholesterol (HDL-C) ratio and related variables; TC, HDL-C, low density lipoprotein cholesterol (LDL-C), TAG, apoA1, ApoB, ApoA1 (apolipoprotein A1)/ApoB (apolipoprotein B), lipoprotein (a) (Lp(a)), NEFA, LDL sub-fractions']","[{'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C4517611', 'cui_str': 'Eighteen point five'}, {'cui': 'C4517674', 'cui_str': '27.5'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0597423', 'cui_str': 'Fatty Acids, Saturated'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipids'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0065055', 'cui_str': 'lipoprotein cholesterol'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0037293', 'cui_str': 'Tag (morphologic abnormality)'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0523476', 'cui_str': 'Apolipoprotein measurement (procedure)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0015688', 'cui_str': 'NEFA'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}]",38.0,0.0699815,"RESULTS


Changes in plasma fatty acids (P < 0.05) confirmed compliance; C18:1 increased with OO compared to PO and CB; C16:0 decreased with OO and C18:0 increased following CB.","[{'ForeName': 'Welma', 'Initials': 'W', 'LastName': 'Stonehouse', 'Affiliation': 'Commonwealth Scientific Industrial Research Organisation, Health and Biosecurity, Adelaide, South Australia, Australia. welma.stonehouse@csiro.au.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Benassi-Evans', 'Affiliation': 'Commonwealth Scientific Industrial Research Organisation, Health and Biosecurity, Adelaide, South Australia, Australia.'}, {'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'James-Martin', 'Affiliation': 'Commonwealth Scientific Industrial Research Organisation, Health and Biosecurity, Adelaide, South Australia, Australia.'}, {'ForeName': 'Mahinda', 'Initials': 'M', 'LastName': 'Abeywardena', 'Affiliation': 'Commonwealth Scientific Industrial Research Organisation, Health and Biosecurity, Adelaide, South Australia, Australia.'}]",European journal of clinical nutrition,['10.1038/s41430-019-0452-7']
1201,31221619,"Epacadostat plus pembrolizumab versus placebo plus pembrolizumab in patients with unresectable or metastatic melanoma (ECHO-301/KEYNOTE-252): a phase 3, randomised, double-blind study.","BACKGROUND


Immunotherapy combination treatments can improve patient outcomes. Epacadostat, an IDO1 selective inhibitor, and pembrolizumab, a PD-1 inhibitor, showed promising antitumour activity in the phase 1-2 ECHO-202/KEYNOTE-037 study in advanced melanoma. In this trial, we aimed to compare progression-free survival and overall survival in patients with unresectable stage III or IV melanoma receiving epacadostat plus pembrolizumab versus placebo plus pembrolizumab.
METHODS


In this international, randomised, placebo-controlled, double-blind, parallel-group, phase 3 trial, eligible participants were aged 18 years or older, with unresectable stage III or IV melanoma previously untreated with PD-1 or PD-L1 checkpoint inhibitors, an ECOG performance status of 0 or 1, and had a known BRAF V600  mutant status or consented to BRAF V600  mutation testing during screening. Patients were stratified by PD-L1 expression and BRAF V600  mutation status and randomly assigned (1:1) through a central interactive voice and integrated web response system to receive epacadostat 100 mg orally twice daily plus pembrolizumab 200 mg intravenously every 3 weeks or placebo plus pembrolizumab for up to 2 years. We used block randomisation with a block size of four in each stratum. Primary endpoints were progression-free survival and overall survival in the intention-to-treat population. The safety analysis population included randomly assigned patients who received at least one dose of study treatment. The study was stopped after the second interim analysis; follow-up for safety is ongoing. This study is registered with ClinicalTrials.gov, number NCT02752074.
FINDINGS


Between June 21, 2016, and Aug 7, 2017, 928 patients were screened and 706 patients were randomly assigned to receive epacadostat plus pembrolizumab (n=354) or placebo plus pembrolizumab (n=352). Median follow-up was 12·4 months (IQR 10·3-14·5). No significant differences were found between the treatment groups for progression-free survival (median 4·7 months, 95% CI 2·9-6·8, for epacadostat plus pembrolizumab vs 4·9 months, 2·9-6·8, for placebo plus pembrolizumab; hazard ratio [HR] 1·00, 95% CI 0·83-1·21; one-sided p=0·52) or overall survival (median not reached in either group; epacadostat plus pembrolizumab vs placebo plus pembrolizumab: HR 1·13, 0·86-1·49; one-sided p=0·81). The most common grade 3 or worse treatment-related adverse event was lipase increase, which occurred in 14 (4%) of 353 patients receiving epacadostat plus pembrolizumab and 11 (3%) of 352 patients receiving placebo plus pembrolizumab. Treatment-related serious adverse events were reported in 37 (10%) of 353 patients receiving epacadostat plus pembrolizumab and 32 (9%) of 352 patients receiving placebo plus pembrolizumab. There were no treatment-related deaths in either treatment group.
INTERPRETATION


Epacadostat 100 mg twice daily plus pembrolizumab did not improve progression-free survival or overall survival compared with placebo plus pembrolizumab in patients with unresectable or metastatic melanoma. The usefulness of IDO1 inhibition as a strategy to enhance anti-PD-1 therapy activity in cancer remains uncertain.
FUNDING


Incyte Corporation, in collaboration with Merck Sharp & Dohme.",2019,Median follow-up was 12·4 months,"['Between June 21, 2016, and Aug 7, 2017, 928 patients were screened and 706 patients', 'Patients were stratified by PD-L1 expression and BRAF V600  mutation status and randomly assigned (1:1) through a', 'eligible participants were aged 18 years or older, with unresectable stage III or IV melanoma previously untreated with PD-1 or PD-L1 checkpoint inhibitors, an ECOG performance status of 0 or 1, and had a known BRAF V600  mutant status or consented to BRAF V600  mutation testing during screening', 'patients with unresectable or metastatic melanoma', 'patients with unresectable or metastatic melanoma (ECHO-301/KEYNOTE-252', 'patients with unresectable stage III or IV melanoma receiving epacadostat plus pembrolizumab versus placebo plus pembrolizumab']","['epacadostat plus pembrolizumab', 'central interactive voice and integrated web response system to receive epacadostat 100 mg orally twice daily plus pembrolizumab 200 mg intravenously every 3 weeks or placebo plus pembrolizumab', 'placebo', 'Epacadostat plus pembrolizumab', 'IDO1 inhibition', 'placebo plus pembrolizumab', 'pembrolizumab']","['progression-free survival', 'progression-free survival and overall survival', 'progression-free survival or overall survival', 'serious adverse events', 'deaths', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C4086265', 'cui_str': 'epacadostat'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C4086265', 'cui_str': 'epacadostat'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",928.0,0.7993,Median follow-up was 12·4 months,"[{'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'Melanoma Institute Australia, University of Sydney, Royal North Shore and Mater Hospitals, Sydney, NSW, Australia. Electronic address: georgina.long@sydney.edu.au.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Dummer', 'Affiliation': 'Department of Dermatology, University Hospital Zürich, Zurich, Switzerland.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Hamid', 'Affiliation': 'The Angeles Clinic and Research Institute, Los Angeles, CA, USA.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Gajewski', 'Affiliation': 'Department of Pathology, University of Chicago Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Caglevic', 'Affiliation': 'Oncology Department, Clinica Alemana Santiago, Universidad del Desarrollo, Santiago, Chile.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Dalle', 'Affiliation': 'Hospices Civils De Lyon, Cancer Research Center of Lyon, Claude Bernard University Lyon, Pierre Benite, France.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Arance', 'Affiliation': 'Medical Oncology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Matteo S', 'Initials': 'MS', 'LastName': 'Carlino', 'Affiliation': 'Westmead and Blacktown Hospitals, Melanoma Institute Australia, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Service de Dermatologie et Cancérologie Cutanée, Aix-Marseille University, Marseille, France.'}, {'ForeName': 'Tae Min', 'Initials': 'TM', 'LastName': 'Kim', 'Affiliation': 'Department of Haemato-Oncology, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Lev', 'Initials': 'L', 'LastName': 'Demidov', 'Affiliation': 'N N Blokhin Russian Cancer Research Center, Moscow, Russia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Gustave Roussy Comprehensive Cancer Center, Villejuif, France.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Anderson', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Maleski', 'Affiliation': 'Incyte Corporation, Wilmington, DE, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Jones', 'Affiliation': 'Incyte Corporation, Wilmington, DE, USA.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Diede', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Tara C', 'Initials': 'TC', 'LastName': 'Mitchell', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30274-8']
1202,31221620,"MRI versus mammography for breast cancer screening in women with familial risk (FaMRIsc): a multicentre, randomised, controlled trial.","BACKGROUND


Approximately 15% of all breast cancers occur in women with a family history of breast cancer, but for whom no causative hereditary gene mutation has been found. Screening guidelines for women with familial risk of breast cancer differ between countries. We did a randomised controlled trial (FaMRIsc) to compare MRI screening with mammography in women with familial risk.
METHODS


In this multicentre, randomised, controlled trial done in 12 hospitals in the Netherlands, women were eligible to participate if they were aged 30-55 years and had a cumulative lifetime breast cancer risk of at least 20% because of a familial predisposition, but were BRCA1, BRCA2, and TP53 wild-type. Participants who were breast-feeding, pregnant, had a previous breast cancer screen, or had a previous a diagnosis of ductal carcinoma in situ were eligible, but those with a previously diagnosed invasive carcinoma were excluded. Participants were randomly allocated (1:1) to receive either annual MRI and clinical breast examination plus biennial mammography (MRI group) or annual mammography and clinical breast examination (mammography group). Randomisation was done via a web-based system and stratified by centre. Women who did not provide consent for randomisation could give consent for registration if they followed either the mammography group protocol or the MRI group protocol in a joint decision with their physician. Results from the registration group were only used in the analyses stratified by breast density. Primary outcomes were number, size, and nodal status of detected breast cancers. Analyses were done by intention to treat. This trial is registered with the Netherlands Trial Register, number NL2661.
FINDINGS


Between Jan 1, 2011, and Dec 31, 2017, 1355 women provided consent for randomisation and 231 for registration. 675 of 1355 women were randomly allocated to the MRI group and 680 to the mammography group. 218 of 231 women opting to be in a registration group were in the mammography registration group and 13 were in the MRI registration group. The mean number of screening rounds per woman was 4·3 (SD 1·76). More breast cancers were detected in the MRI group than in the mammography group (40 vs 15; p=0·0017). Invasive cancers (24 in the MRI group and eight in the mammography group) were smaller in the MRI group than in the mammography group (median size 9 mm [5-14] vs 17 mm [13-22]; p=0·010) and less frequently node positive (four [17%] of 24 vs five [63%] of eight; p=0·023). Tumour stages of the cancers detected at incident rounds were significantly earlier in the MRI group (12 [48%] of 25 in the MRI group vs one [7%] of 15 in the mammography group were stage T1a and T1b cancers; one (4%) of 25 in the MRI group and two (13%) of 15 in the mammography group were stage T2 or higher; p=0·035) and node-positive tumours were less frequent (two [11%] of 18 in the MRI group vs five [63%] of eight in the mammography group; p=0·014). All seven tumours stage T2 or higher were in the two highest breast density categories (breast imaging reporting and data system categories C and D; p=0·0077) One patient died from breast cancer during follow-up (mammography registration group).
INTERPRETATION


MRI screening detected cancers at an earlier stage than mammography. The lower number of late-stage cancers identified in incident rounds might reduce the use of adjuvant chemotherapy and decrease breast cancer-related mortality. However, the advantages of the MRI screening approach might be at the cost of more false-positive results, especially at high breast density.
FUNDING


Dutch Government ZonMw, Dutch Cancer Society, A Sister's Hope, Pink Ribbon, Stichting Coolsingel, J&T Rijke Stichting.",2019,Invasive cancers (24 in the MRI group and eight in the mammography group) were smaller in the MRI group than in the mammography group (median size 9 mm [5-14] vs 17 mm [13-22]; p=0·010) and less frequently node positive (four [17%] of 24 vs five [63%] of eight; p=0·023).,"['women with familial risk (FaMRIsc', '12 hospitals in the Netherlands, women were eligible to participate if they were aged 30-55 years and had a cumulative lifetime breast cancer risk of at least 20% because of a familial predisposition, but were BRCA1, BRCA2, and TP53 wild-type', '218 of 231 women opting to be in a registration group were in the mammography registration group and 13 were in the MRI registration group', '675 of 1355 women', 'women with a family history of breast cancer', 'Participants who were breast-feeding, pregnant, had a previous breast cancer screen, or had a previous a diagnosis of ductal carcinoma in situ were eligible, but those with a previously diagnosed invasive carcinoma were excluded', 'women with familial risk', 'Between Jan 1, 2011, and Dec 31, 2017, 1355 women provided consent for randomisation and 231 for registration', 'women with familial risk of breast cancer differ between countries']","['MRI', 'annual MRI and clinical breast examination plus biennial mammography (MRI group) or annual mammography and clinical breast examination (mammography group', 'MRI screening with mammography', 'MRI versus mammography']","['mean number of screening rounds per woman was 4·3', 'Invasive cancers', 'number, size, and nodal status of detected breast cancers', 'breast cancers']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1611743', 'cui_str': 'Familial (FPAH)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C4517854', 'cui_str': '675 (qualifier value)'}, {'cui': 'C1261325', 'cui_str': 'Family history of malignant neoplasm of breast'}, {'cui': 'C0006147', 'cui_str': 'Breastfeeding'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0007124', 'cui_str': 'Ductal Carcinoma In Situ'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0007097', 'cui_str': 'Epithelioma'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0199850', 'cui_str': 'Examination of breast (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]",1355.0,0.189719,Invasive cancers (24 in the MRI group and eight in the mammography group) were smaller in the MRI group than in the mammography group (median size 9 mm [5-14] vs 17 mm [13-22]; p=0·010) and less frequently node positive (four [17%] of 24 vs five [63%] of eight; p=0·023).,"[{'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Saadatmand', 'Affiliation': 'Department of Surgery, Erasmus University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'H Amarens', 'Initials': 'HA', 'LastName': 'Geuzinge', 'Affiliation': 'Department of Public Health, Erasmus University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Emiel J T', 'Initials': 'EJT', 'LastName': 'Rutgers', 'Affiliation': 'Department of Surgery, The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands.'}, {'ForeName': 'Ritse M', 'Initials': 'RM', 'LastName': 'Mann', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Radboud University Hospital, Nijmegen, Netherlands.'}, {'ForeName': 'Diderick B W', 'Initials': 'DBW', 'LastName': 'de Roy van Zuidewijn', 'Affiliation': 'Department of Surgery, Medical Centre Leeuwarden, Leeuwarden, Netherlands.'}, {'ForeName': 'Harmien M', 'Initials': 'HM', 'LastName': 'Zonderland', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Rob A E M', 'Initials': 'RAEM', 'LastName': 'Tollenaar', 'Affiliation': 'Department of Surgery, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Marc B I', 'Initials': 'MBI', 'LastName': 'Lobbes', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Margreet G E M', 'Initials': 'MGEM', 'LastName': 'Ausems', 'Affiliation': 'Department of Genetics, University Medical Centre Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Martijne', 'Initials': 'M', 'LastName': ""van 't Riet"", 'Affiliation': 'Department of Surgery, Reinier de Graaf Gasthuis, Delft, Netherlands.'}, {'ForeName': 'Maartje J', 'Initials': 'MJ', 'LastName': 'Hooning', 'Affiliation': 'Department of Medical Oncology, Erasmus University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Ingeborg', 'Initials': 'I', 'LastName': 'Mares-Engelberts', 'Affiliation': 'Department of Surgery, Vlietland Ziekenhuis, Schiedam, Netherlands.'}, {'ForeName': 'Ernest J T', 'Initials': 'EJT', 'LastName': 'Luiten', 'Affiliation': 'Department of Surgery, Amphia Ziekenhuis, Breda, Netherlands.'}, {'ForeName': 'Eveline A M', 'Initials': 'EAM', 'LastName': 'Heijnsdijk', 'Affiliation': 'Department of Public Health, Erasmus University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Cees', 'Initials': 'C', 'LastName': 'Verhoef', 'Affiliation': 'Department of Surgery, Erasmus University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Nico', 'Initials': 'N', 'LastName': 'Karssemeijer', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Radboud University Hospital, Nijmegen, Netherlands.'}, {'ForeName': 'Jan C', 'Initials': 'JC', 'LastName': 'Oosterwijk', 'Affiliation': 'Department of Genetics, Groningen University, University Medical Centre Groningen, Groningen, Netherlands.'}, {'ForeName': 'Inge-Marie', 'Initials': 'IM', 'LastName': 'Obdeijn', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Erasmus University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Harry J', 'Initials': 'HJ', 'LastName': 'de Koning', 'Affiliation': 'Department of Public Health, Erasmus University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Madeleine M A', 'Initials': 'MMA', 'LastName': 'Tilanus-Linthorst', 'Affiliation': 'Department of Surgery, Erasmus University Medical Center, Rotterdam, Netherlands. Electronic address: madeleinetilanus@hotmail.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30275-X']
1203,31591062,"Real-time artificial intelligence for detection of upper gastrointestinal cancer by endoscopy: a multicentre, case-control, diagnostic study.","BACKGROUND


Upper gastrointestinal cancers (including oesophageal cancer and gastric cancer) are the most common cancers worldwide. Artificial intelligence platforms using deep learning algorithms have made remarkable progress in medical imaging but their application in upper gastrointestinal cancers has been limited. We aimed to develop and validate the Gastrointestinal Artificial Intelligence Diagnostic System (GRAIDS) for the diagnosis of upper gastrointestinal cancers through analysis of imaging data from clinical endoscopies.
METHODS


This multicentre, case-control, diagnostic study was done in six hospitals of different tiers (ie, municipal, provincial, and national) in China. The images of consecutive participants, aged 18 years or older, who had not had a previous endoscopy were retrieved from all participating hospitals. All patients with upper gastrointestinal cancer lesions (including oesophageal cancer and gastric cancer) that were histologically proven malignancies were eligible for this study. Only images with standard white light were deemed eligible. The images from Sun Yat-sen University Cancer Center were randomly assigned (8:1:1) to the training and intrinsic verification datasets for developing GRAIDS, and the internal validation dataset for evaluating the performance of GRAIDS. Its diagnostic performance was evaluated using an internal and prospective validation set from Sun Yat-sen University Cancer Center (a national hospital) and additional external validation sets from five primary care hospitals. The performance of GRAIDS was also compared with endoscopists with three degrees of expertise: expert, competent, and trainee. The diagnostic accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of GRAIDS and endoscopists for the identification of cancerous lesions were evaluated by calculating the 95% CIs using the Clopper-Pearson method.
FINDINGS


1 036 496 endoscopy images from 84 424 individuals were used to develop and test GRAIDS. The diagnostic accuracy in identifying upper gastrointestinal cancers was 0·955 (95% CI 0·952-0·957) in the internal validation set, 0·927 (0·925-0·929) in the prospective set, and ranged from 0·915 (0·913-0·917) to 0·977 (0·977-0·978) in the five external validation sets. GRAIDS achieved diagnostic sensitivity similar to that of the expert endoscopist (0·942 [95% CI 0·924-0·957] vs 0·945 [0·927-0·959]; p=0·692) and superior sensitivity compared with competent (0·858 [0·832-0·880], p<0·0001) and trainee (0·722 [0·691-0·752], p<0·0001) endoscopists. The positive predictive value was 0·814 (95% CI 0·788-0·838) for GRAIDS, 0·932 (0·913-0·948) for the expert endoscopist, 0·974 (0·960-0·984) for the competent endoscopist, and 0·824 (0·795-0·850) for the trainee endoscopist. The negative predictive value was 0·978 (95% CI 0·971-0·984) for GRAIDS, 0·980 (0·974-0·985) for the expert endoscopist, 0·951 (0·942-0·959) for the competent endoscopist, and 0·904 (0·893-0·916) for the trainee endoscopist.
INTERPRETATION


GRAIDS achieved high diagnostic accuracy in detecting upper gastrointestinal cancers, with sensitivity similar to that of expert endoscopists and was superior to that of non-expert endoscopists. This system could assist community-based hospitals in improving their effectiveness in upper gastrointestinal cancer diagnoses.
FUNDING


The National Key R&D Program of China, the Natural Science Foundation of Guangdong Province, the Science and Technology Program of Guangdong, the Science and Technology Program of Guangzhou, and the Fundamental Research Funds for the Central Universities.",2019,The positive predictive value was 0·814,"['consecutive participants, aged 18 years or older, who had not had a previous endoscopy were retrieved from all participating hospitals', '0·927-0·959', 'Sun Yat-sen University Cancer Center (a national hospital) and additional external validation sets from five primary care hospitals', 'Sun Yat-sen University Cancer Center', 'All patients with upper gastrointestinal cancer lesions (including oesophageal cancer and gastric cancer', '1\u2008036', '496 endoscopy images from 84\u2008424 individuals', 'six hospitals of different tiers (ie, municipal, provincial, and national) in China', 'Upper gastrointestinal cancers (including oesophageal cancer and gastric cancer']","['Gastrointestinal Artificial Intelligence Diagnostic System (GRAIDS', 'Real-time artificial intelligence']","['superior sensitivity', 'diagnostic sensitivity', 'diagnostic accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of GRAIDS and endoscopists for the identification of cancerous lesions']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0337952', 'cui_str': 'Primary care hospital (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0685938', 'cui_str': 'Gastrointestinal Cancer'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0003916', 'cui_str': 'AI (Artificial Intelligence)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]",,0.0356061,The positive predictive value was 0·814,"[{'ForeName': 'Huiyan', 'Initials': 'H', 'LastName': 'Luo', 'Affiliation': 'Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Guoliang', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Department of Endoscopy, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Chaofeng', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Artificial Intelligence Laboratory, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Longjun', 'Initials': 'L', 'LastName': 'He', 'Affiliation': 'Department of Endoscopy, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Linna', 'Initials': 'L', 'LastName': 'Luo', 'Affiliation': 'Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Zixian', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Bingzhong', 'Initials': 'B', 'LastName': 'Jing', 'Affiliation': 'Artificial Intelligence Laboratory, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yishu', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Artificial Intelligence Laboratory, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Endoscopy, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Artificial Intelligence Laboratory, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Wencheng', 'Initials': 'W', 'LastName': 'Tan', 'Affiliation': 'Department of Endoscopy, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Caisheng', 'Initials': 'C', 'LastName': 'He', 'Affiliation': 'Artificial Intelligence Laboratory, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Sharvesh Raj', 'Initials': 'SR', 'LastName': 'Seeruttun', 'Affiliation': 'Department of Gastric Surgery, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Qiubao', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Department of Endoscopy, Jiangxi Cancer Hospital, Nanchang, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Endoscopy, Jiangxi Cancer Hospital, Nanchang, China.'}, {'ForeName': 'De-Wang', 'Initials': 'DW', 'LastName': 'Huang', 'Affiliation': 'Department of Digestive Internal, Wuzhou Red Cross Hospital, Wuzhou, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': ""Department of Digestive Internal, The North Guangdong People's Hospital, Shaoguan, China.""}, {'ForeName': 'Shao-Bin', 'Initials': 'SB', 'LastName': 'Lin', 'Affiliation': ""Department of Digestive Internal, Puning People's Hospital, Puning, China.""}, {'ForeName': 'Qin-Ming', 'Initials': 'QM', 'LastName': 'Chen', 'Affiliation': ""Department of Digestive Internal, Puning People's Hospital, Puning, China.""}, {'ForeName': 'Chu-Ming', 'Initials': 'CM', 'LastName': 'Yuan', 'Affiliation': ""Department of Digestive Internal, Jieyang People's Hospital, Jieyang, China.""}, {'ForeName': 'Hai-Xin', 'Initials': 'HX', 'LastName': 'Chen', 'Affiliation': ""Department of Digestive Internal, Jieyang People's Hospital, Jieyang, China.""}, {'ForeName': 'Heng-Ying', 'Initials': 'HY', 'LastName': 'Pu', 'Affiliation': 'Medical Administration Department, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'Medical Administration Department, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Medical Administration Department, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Rui-Hua', 'Initials': 'RH', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China. Electronic address: xurh@sysucc.org.cn.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30637-0']
1204,31222868,Effect of alcohol on the sense of agency in healthy humans.,"Even at low to moderate doses, ingestion of the widely used recreational drug alcohol (ethanol) can impact cognitive and emotional processing. Recent studies show that the sense of agency (SoA; ie, the subjective experience of voluntary control over actions) can be modulated by specific pharmacological manipulations. The SoA, as quantified by the intentional binding (IB) paradigm, is enhanced by direct or indirect dopaminergic agonists in patients with Parkinson's disease and by ketamine (an N-methyl-D-aspartate (NMDA) receptor antagonist) in healthy individuals. These findings implicate dopaminergic and glutamatergic neurotransmission in mechanisms underlying SoA. Alcohol has a complex set of actions, including disinhibition of dopaminergic neurotransmission and allosteric antagonism at NMDA receptors. Here, we tested the hypothesis that low to moderate doses of alcohol would enhance SoA, and impact impulsivity and subjective emotional state. We conducted two experiments in 59 healthy male and female social drinkers, who ingested either a placebo ""vehicle,"" or one of two doses of ethanol: 0.4 and 0.6 g/kg. In both experiments, we observed increased SoA/IB at both doses of alcohol exposure, relative to the placebo condition. We found no correlation between the effects of alcohol on IB and on impulsivity or subjective emotional state. Our findings might have implications for social and legal responsibility related to alcohol use, particularly in states prior to overt intoxication. Further studies are necessary to investigate the effects of alcohol and other addictive substances on the SoA.",2020,We found no correlation between the effects of alcohol on IB and on impulsivity or subjective emotional state.,"['healthy humans', ""patients with Parkinson's disease and by ketamine (an N-methyl-D-aspartate (NMDA) receptor antagonist) in healthy individuals"", '59 healthy male and female social drinkers, who ingested either a placebo ""vehicle,"" or one of two doses of ethanol: 0.4 and 0.6 g/kg']",['alcohol'],"['IB and on impulsivity or subjective emotional state', 'enhance SoA, and impact impulsivity and subjective emotional state']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C4521484', 'cui_str': 'N-methyl-D-aspartate receptor antagonist (disposition)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0337676', 'cui_str': 'Social drinker (finding)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0202304', 'cui_str': 'Alcohol measurement (procedure)'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C4068883', 'cui_str': 'Zero point six'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0021125', 'cui_str': 'Impulsivity'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]",59.0,0.0145121,We found no correlation between the effects of alcohol on IB and on impulsivity or subjective emotional state.,"[{'ForeName': 'Silvana', 'Initials': 'S', 'LastName': 'De Pirro', 'Affiliation': 'Sussex Addiction Research and Intervention Centre (SARIC), School of Psychology, University of Sussex, Brighton, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lush', 'Affiliation': 'Sussex Addiction Research and Intervention Centre (SARIC), School of Psychology, University of Sussex, Brighton, UK.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Parkinson', 'Affiliation': 'Sackler Centre for Consciousness Science, University of Sussex, Brighton, UK.'}, {'ForeName': 'Theodora', 'Initials': 'T', 'LastName': 'Duka', 'Affiliation': 'Sussex Addiction Research and Intervention Centre (SARIC), School of Psychology, University of Sussex, Brighton, UK.'}, {'ForeName': 'Hugo D', 'Initials': 'HD', 'LastName': 'Critchley', 'Affiliation': 'Sussex Addiction Research and Intervention Centre (SARIC), School of Psychology, University of Sussex, Brighton, UK.'}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Badiani', 'Affiliation': 'Sussex Addiction Research and Intervention Centre (SARIC), School of Psychology, University of Sussex, Brighton, UK.'}]",Addiction biology,['10.1111/adb.12796']
1205,30825414,Online participatory intervention to promote and support exclusive breastfeeding: Randomized clinical trial.,"The support offered to mothers after hospital discharge can be decisive in maintaining exclusive breastfeeding during the first 6 months post-partum. The objective of this study was to assess the impact on the duration of exclusive breastfeeding of a participatory intervention using an online social network. A randomized clinical trial was performed involving 251 mother-child pairings in a university hospital in the Northeast of Brazil, 123 of which assigned to the intervention group and 128 to the control group. After hospital discharge, the intervention group was followed through a closed group of an online social network, where weekly posters were published on topics related to breastfeeding and an active communication was established with the mothers. The groups were interviewed monthly over the phone until the child reached 6 months of age. The duration of exclusive breastfeeding was calculated through survival analysis, and the effect of the intervention was estimated through the Cox regression model. The exclusive breastfeeding frequencies were higher in the intervention group in all follow-up months, reaching 33.3% in the sixth month versus 8.3% in the control group. The median exclusive breastfeeding duration was 149 days (95% CI [129.6, 168.4]) in the intervention group and 86 days (95% CI [64.9, 107.1]) in the control group (P < 0.0001). The proportional risk of early interruption of exclusive breastfeeding was 0.38 (95% CI [0.28, 0.51], P < 0.0001). This intervention had a positive impact on the duration and frequency of exclusive breastfeeding.",2019,"The exclusive breastfeeding frequencies were higher in the intervention group in all follow-up months, reaching 33.3% in the sixth month versus 8.3% in the control group.","['251 mother-child pairings in a university hospital in the Northeast of Brazil, 123 of which assigned to the intervention group and 128 to the control group']",['Online participatory intervention to promote and support exclusive breastfeeding'],"['exclusive breastfeeding frequencies', 'proportional risk of early interruption of exclusive breastfeeding', 'median exclusive breastfeeding duration', 'duration of exclusive breastfeeding', 'duration and frequency of exclusive breastfeeding']","[{'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}]","[{'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205351', 'cui_str': 'Proportional (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",251.0,0.0762054,"The exclusive breastfeeding frequencies were higher in the intervention group in all follow-up months, reaching 33.3% in the sixth month versus 8.3% in the control group.","[{'ForeName': 'Débora Silva', 'Initials': 'DS', 'LastName': 'Cavalcanti', 'Affiliation': 'Post-Graduate Program in Nutrition, Pernambuco Federal University, Recife, Brazil.'}, {'ForeName': 'Caroline Sousa', 'Initials': 'CS', 'LastName': 'Cabral', 'Affiliation': 'Post-Graduate Program in Nutrition, Paraíba Federal University, João Pessoa, Brazil.'}, {'ForeName': 'Rodrigo Pinheiro', 'Initials': 'RP', 'LastName': 'de Toledo Vianna', 'Affiliation': 'Post-Graduate Program in Nutrition, Paraíba Federal University, João Pessoa, Brazil.'}, {'ForeName': 'Mônica Maria', 'Initials': 'MM', 'LastName': 'Osório', 'Affiliation': 'Post-Graduate Program in Nutrition, Pernambuco Federal University, Recife, Brazil.'}]",Maternal & child nutrition,['10.1111/mcn.12806']
1206,31687769,Impact of Smoking Cessation Interventions Initiated During Hospitalization Among HIV-Infected Smokers.,"INTRODUCTION


Smoking is a key determinant of mortality among people living with HIV (PLWH).
METHODS


To better understand the effects of smoking cessation interventions in PLWH, we conducted a pooled analysis of four randomized controlled trials of hospital-initiated smoking interventions conducted through the Consortium of Hospitals Advancing Research on Tobacco (CHART). In each study, cigarette smokers were randomly assigned to usual care or a smoking cessation intervention. The primary outcome was self-reported past 30-day tobacco abstinence at 6-month follow-up. Abstinence rates were compared between PLWH and participants without HIV and by treatment arm, using both complete-case and intention-to-treat analyses. Multivariable logistic regression was used to determine the effect of HIV status on 6-month tobacco abstinence and to determine predictors of smoking cessation within PLWH.
RESULTS


Among 5550 hospitalized smokers, there were 202 (3.6%) PLWH. PLWH smoked fewer cigarettes per day and were less likely to be planning to quit than smokers without HIV. At 6 months, cessation rates did not differ between intervention and control groups among PLWH (28.9% vs. 30.5%) or smokers without HIV (36.1% vs. 34.1%). In multivariable regression analysis, HIV status was not significantly associated with smoking cessation at 6 months. Among PLWH, confidence in quitting was the only clinical factor independently associated with smoking cessation (OR 2.0, 95% CI = 1.4 to 2.8, p < .01).
CONCLUSIONS


HIV status did not alter likelihood of quitting smoking after hospital discharge, whether or not the smoker was offered a tobacco cessation intervention, but power was limited to identify potentially important differences.
IMPLICATIONS


PLWH had similar quit rates to participants without HIV following a hospital-initiated smoking cessation intervention. The findings suggest that factors specific to HIV infection may not influence response to smoking cessation interventions and that all PLWH would benefit from efforts to assist in quitting smoking.
TRIAL REGISTRATION


(1) Using ""warm handoffs"" to link hospitalized smokers with tobacco treatment after discharge: study protocol of a randomized controlled trial: NCT01305928. (2) Web-based smoking cessation intervention that transitions from inpatient to outpatient: NCT01277250. (3) Effectiveness of smoking-cessation interventions for urban hospital patients: NCT01363245. (4) Effectiveness of Post-Discharge Strategies for Hospitalized Smokers (HelpingHAND2): NCT01714323.",2020,"At 6 months, cessation rates did not differ between intervention and control groups among PLWH (28.9% vs. 30.5%) or smokers without HIV (36.1% vs. 34.1%).","['Hospitalized Smokers (HelpingHAND2', 'people living with HIV (PLWH', '5550 hospitalized smokers', 'hospitalized smokers with tobacco treatment after discharge', 'hospital-initiated smoking interventions conducted through the Consortium of Hospitals Advancing Research on Tobacco (CHART', 'HIV-Infected Smokers', 'participants without HIV following a hospital-initiated smoking cessation intervention', 'urban hospital patients', 'cigarette smokers']","['usual care or a smoking cessation intervention', 'Post-Discharge Strategies', 'PLWH', 'smoking-cessation interventions', 'Smoking Cessation Interventions']","['Abstinence rates', 'smoking cessation', 'self-reported past 30-day tobacco abstinence', 'cessation rates', 'quit rates']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0035168'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0020029', 'cui_str': 'Hospitals, Metropolitan'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}]",,0.0487106,"At 6 months, cessation rates did not differ between intervention and control groups among PLWH (28.9% vs. 30.5%) or smokers without HIV (36.1% vs. 34.1%).","[{'ForeName': 'Virginia A', 'Initials': 'VA', 'LastName': 'Triant', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Grossman', 'Affiliation': 'Cambridge Health Alliance, Somerville, MA.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Rigotti', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Rekha', 'Initials': 'R', 'LastName': 'Ramachandran', 'Affiliation': 'Division of Preventive Medicine, School of Medicine, University of Alabama, Birmingham, AL.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Regan', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Sherman', 'Affiliation': 'Department of Population Health, New York University School of Medicine, New York, NY.'}, {'ForeName': 'Kimber P', 'Initials': 'KP', 'LastName': 'Richter', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Kansas Medical Center, Kansas City, Kansas, Nashville, TN.'}, {'ForeName': 'Hilary A', 'Initials': 'HA', 'LastName': 'Tindle', 'Affiliation': 'Division of General Internal Medicine and Public Health, Vanderbilt University School of Medicine, Nashville, TN.'}, {'ForeName': 'Kathleen F', 'Initials': 'KF', 'LastName': 'Harrington', 'Affiliation': 'Division of Pulmonary, Allergy and Critical Care Medicine, School of Medicine, University of Alabama, Birmingham, AL.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz168']
1207,31217148,Coronary vasomotor function and myocardial flow with bioresorbable vascular scaffolds or everolimus-eluting metallic stents: a randomised trial.,"AIMS


The aim of this study was to compare the hyperaemic flow and vasomotor response to endothelium-dependent stimuli between bioresorbable vascular scaffolds (BVS) and metallic everolimus-eluting stents (EES) at 13 months.
METHODS AND RESULTS


Seventy non-diabetic patients aiming to achieve complete revascularisation were randomised 1:1 to BVS or EES implantation. At 13 months, invasive coronary angiography was performed using intracoronary pressure and Doppler ultrasound measurements at rest and maximal hyperaemia. A vasomotor test to endothelium-dependent (acetylcholine) and independent (nitroglycerine) stimuli and optical coherence tomography (OCT) were also performed. Fifty-nine patients (30 BVS and 29 EES) underwent 13-month examination. Doppler ultrasound average peak velocity (49.0±17.5 vs 49.3±18.3 cm/sec; p=0.95), coronary blood flow (97.4±53.5 vs 88.3±46.7 ml/min; p=0.51), coronary flow reserve (2.6±0.9 vs 2.7±0.8; p=0.84) and fractional flow reserve (0.92±0.06 vs 0.94±0.04; p=0.17) were similar between the groups. The vasomotor test showed vasoconstriction response to acetylcholine in 75.6% proximal and 72.2% distal peri-scaffold segments without differences between study devices. BVS had larger in-scaffold vasoconstriction than EES (60.0% vs 27.6%; p=0.01) despite similar neointima response as assessed by OCT.
CONCLUSIONS


BVS and EES had similar microcirculatory response to hyperaemia and predominant vasoconstrictive response in the peri-scaffold segments to endothelium-dependent stimuli. However, BVS exhibited larger vasoconstriction to endothelium-dependent stimuli in the scaffold segment.",2020,"Doppler-ultrasound average peak velocity (49.0±17.5 vs. 49.3±18.3 cm/sc.; p=0.95), coronary blood flow (97.4±53.5 vs. 88.3 ± 46.7 ml/min; p=0.51), coronary flow reserve (2.6±0.9 vs. 2.7±0.8; p=0.84) and fractional flow reserve (0.92±0.06 vs. 0.94±0.04; p=0.17) were similar between groups.","['Seventy non-diabetic patients aimed to achieve complete revascularization', 'patients treated with everolimus-eluting bioresorbable scaffolds and everolimus-eluting metallic stents', 'Fifty-nine patients (30 BVS and 29 EES) underwent 13-month examination']","['Vasomotor test to endothelial-dependent (acetylcholine) and independent (nitroglycerine) stimuli and Optical Coherence Tomography (OCT', 'BVS or EES implantation', 'Bioresorbable Vascular Scaffolds (BVS) and metallic Everolimus-Eluting Stents (EES', 'acetylcholine']","['fractional flow reserve', 'vasoconstriction response', 'coronary blood flow', 'Doppler-ultrasound average peak velocity', 'coronary flow reserve', 'hyperemic flow and vasomotor response', 'neointima response']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0337143', 'cui_str': 'Scaffold, device (physical object)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0337143', 'cui_str': 'Scaffold, device (physical object)'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}]","[{'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C1456863', 'cui_str': 'Vasoconstriction'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0162481', 'cui_str': 'Doppler Ultrasound'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C2936380', 'cui_str': 'Neointima'}]",70.0,0.0565155,"Doppler-ultrasound average peak velocity (49.0±17.5 vs. 49.3±18.3 cm/sc.; p=0.95), coronary blood flow (97.4±53.5 vs. 88.3 ± 46.7 ml/min; p=0.51), coronary flow reserve (2.6±0.9 vs. 2.7±0.8; p=0.84) and fractional flow reserve (0.92±0.06 vs. 0.94±0.04; p=0.17) were similar between groups.","[{'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Gomez-Lara', 'Affiliation': 'Grup de Recerca en Malalties del Cor, Hospital Universitari de Bellvitge; Institut d´Investigacio Biomedica de Bellvitge (IDIBELL), Universitat de Barcelona, L´Hospitalet de Llobregat, Spain.'}, {'ForeName': 'Neus', 'Initials': 'N', 'LastName': 'Salvatella', 'Affiliation': ''}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Romaguera', 'Affiliation': ''}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Brugaletta', 'Affiliation': ''}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Ñato', 'Affiliation': ''}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Roura', 'Affiliation': ''}, {'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'Ferreiro', 'Affiliation': ''}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Teruel', 'Affiliation': ''}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Gracida', 'Affiliation': ''}, {'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Sabate', 'Affiliation': ''}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Vaquerizo', 'Affiliation': ''}, {'ForeName': 'Àngel', 'Initials': 'À', 'LastName': 'Cequier', 'Affiliation': ''}, {'ForeName': 'Joan-Antoni', 'Initials': 'JA', 'LastName': 'Gomez-Hospital', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-18-01203']
1208,31786746,Effectiveness of barbed repositioning pharyngoplasty for the treatment of obstructive sleep apnea (OSA): a prospective randomized trial.,"PURPOSE


The aim of our randomized clinical trial is to produce stronger evidence supporting barbed repositioning pharyngoplasty (BRP) as a therapeutic option for the treatment of obstructive sleep apnea (OSA).
METHODS


The trial was a single-center prospective controlled trial with two parallel arms (group A: BRP; group B: observation) and randomization. Baseline and 6-month polygraphy evaluating the apnea hypopnea index (AHI), oxygen desaturation index (ODI), and lowest oxygen saturation (LOS) were performed. To test the differences among groups of Student's t test, the role of each factor (univariate analysis) and their independent effect (multivariate analysis) was explored using logistic regression model as appropriate. Linear regression was also conducted.
RESULTS


A significant reduction of AHI, ODI, LOS, and Epworth Sleepiness Scale (ESS) values was recorded in the BRP group. BRP showed to be more effective than observation. Logistic regression showed that preoperative AHI is related significantly to postoperative AHI within the BRP group. A linear regression showed that higher baseline AHI predicts more significant postoperative absolute AHI reduction.
CONCLUSIONS


BRP appears to be a promising technique and might be included within the surgical armamentarium of a sleep surgeon. Patients affected by severe OSA may benefit from this surgery with more significant reduction of AHI values.",2020,"A significant reduction of AHI, ODI, LOS, and Epworth Sleepiness Scale (ESS) values was recorded in the BRP group.",['obstructive sleep apnea (OSA'],"['barbed repositioning pharyngoplasty (BRP', 'barbed repositioning pharyngoplasty']","['AHI, ODI, LOS, and Epworth Sleepiness Scale (ESS) values', 'AHI values', 'apnea hypopnea index (AHI), oxygen desaturation index (ODI), and lowest oxygen saturation (LOS']","[{'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C0556030', 'cui_str': 'Repositioning (procedure)'}, {'cui': 'C1609480', 'cui_str': 'Pharyngoplasty'}]","[{'cui': 'C3541276', 'cui_str': 'ESS - Epworth Sleepiness Scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range (finding)'}]",,0.0221504,"A significant reduction of AHI, ODI, LOS, and Epworth Sleepiness Scale (ESS) values was recorded in the BRP group.","[{'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Vicini', 'Affiliation': 'Unit of Otolaryngology, Hospital Morgagni Pierantoni, Forlì, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Meccariello', 'Affiliation': 'Unit of Otolaryngology, Hospital Morgagni Pierantoni, Forlì, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Montevecchi', 'Affiliation': 'Unit of Otolaryngology, Hospital Morgagni Pierantoni, Forlì, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'De Vito', 'Affiliation': 'Unit of Otolaryngology, Hospital Morgagni Pierantoni, Forlì, Italy.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Frassineti', 'Affiliation': 'Unit of Otolaryngology, Hospital Morgagni Pierantoni, Forlì, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Gobbi', 'Affiliation': 'Unit of Otolaryngology, Hospital Morgagni Pierantoni, Forlì, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Pelucchi', 'Affiliation': 'Unit of Otolaryngology, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Giannicola', 'Initials': 'G', 'LastName': 'Iannella', 'Affiliation': 'Unit of Otolaryngology, La Sapienza University, Rome, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Magliulo', 'Affiliation': 'Unit of Otolaryngology, La Sapienza University, Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Cammaroto', 'Affiliation': 'Unit of Otolaryngology, Hospital Morgagni Pierantoni, Forlì, Italy. giovanni.cammaroto@hotmail.com.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-019-01956-7']
1209,31786121,"Atezolizumab plus nab-paclitaxel as first-line treatment for unresectable, locally advanced or metastatic triple-negative breast cancer (IMpassion130): updated efficacy results from a randomised, double-blind, placebo-controlled, phase 3 trial.","BACKGROUND


Immunotherapy in combination with chemotherapy has shown promising efficacy across many different tumour types. We report the prespecified second interim overall survival analysis of the phase 3 IMpassion130 study assessing the efficacy and safety of atezolizumab plus nab-paclitaxel in patients with unresectable, locally advanced or metastatic triple-negative breast cancer.
METHODS


In this randomised, placebo-controlled, double-blind, phase 3 trial, done in 246 academic centres and community oncology practices in 41 countries, patients aged 18 years or older, with previously untreated, histologically documented, locally advanced or metastatic triple-negative breast cancer, and Eastern Cooperative Oncology Group performance status of 0 or 1 were eligible. Patients were randomly assigned (1:1) using a permuted block method (block size of four) and an interactive voice-web response system. Randomisation was stratified by previous taxane use, liver metastases, and PD-L1 expression on tumour-infiltrating immune cells. Patients received atezolizumab 840 mg or matching placebo intravenously on day 1 and day 15 of every 28-day cycle and nab-paclitaxel 100 mg/m 2  of body surface area intravenously on days 1, 8, and 15 until progression or unacceptable toxicity. Investigators, patients, and the funder were masked to treatment assignment. Coprimary endpoints were investigator-assessed progression-free survival per Response Evaluation Criteria in Solid Tumors version 1.1 and overall survival, assessed in the intention-to-treat population and in patients with PD-L1 immune cell-positive tumours (tumours with ≥1% PD-L1 expression). The final progression-free survival results were previously reported at the first interim overall survival analysis. The prespecified statistical testing hierarchy meant that overall survival in the subgroup of PD-L1 immune cell-positive patients could only be formally tested if overall survival was significantly different between the treatment groups in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT02425891.
FINDINGS


Between June 23, 2015, and May 24, 2017, 902 patients were enrolled, of whom 451 were randomly assigned to receive atezolizumab plus nab-paclitaxel and 451 were assigned to receive placebo plus nab-paclitaxel (the intention-to-treat population). Six patients from each group did not receive treatment. At the second interim analysis (data cutoff Jan 2, 2019), median follow-up was 18·5 months (IQR 9·6-22·8) in the atezolizumab group and 17·5 months (8·4-22·4) in the placebo group. Median overall survival in the intention-to-treat patients was 21·0 months (95% CI 19·0-22·6) with atezolizumab and 18·7 months (16·9-20·3) with placebo (stratified hazard ratio [HR] 0·86, 95% CI 0·72-1·02, p=0·078). In the exploratory overall survival analysis in patients with PD-L1 immune cell-positive tumours, median overall survival was 25·0 months (95% CI 19·6-30·7) with atezolizumab versus 18·0 months (13·6-20·1) with placebo (stratified HR 0·71, 0·54-0·94]). As of Sept 3, 2018 (the date up to which updated safety data were available), the most common grade 3-4 adverse events were neutropenia (38 [8%] of 453 patients in the atezolizumab group vs 36 [8%] of 437 patients in the placebo group), peripheral neuropathy (25 [6%] vs 12 [3%]), decreased neutrophil count (22 [5%] vs 16 [4%]), and fatigue (17 [4%] vs 15 [3%]). Treatment-related deaths occurred in two (<1%) patients in the atezolizumab group (autoimmune hepatitis related to atezolizumab [n=1] and septic shock related to nab-paclitaxel [n=1]) and one (<1%) patient in the placebo group (hepatic failure). No new treatment-related deaths have been reported since the primary clinical data cutoff date (April 17, 2018).
INTERPRETATION


Consistent with the first interim analysis, this second interim overall survival analysis of IMpassion130 indicates no significant difference in overall survival between the treatment groups in the intention-to-treat population but suggests a clinically meaningful overall survival benefit with atezolizumab plus nab-paclitaxel in patients with PD-L1 immune cell-positive disease. However, this positive result could not be formally tested due to the prespecified statistical testing hierarchy. For patients with PD-L1 immune cell-positive metastatic triple-negative breast cancer, atezolizumab plus nab-paclitaxel is an important therapeutic option in a disease with high unmet need.
FUNDING


F Hoffmann-La Roche and Genentech.",2020,Treatment-related deaths occurred in two (<1%) patients in the atezolizumab group (autoimmune hepatitis related to atezolizumab [n=1] and septic shock related to nab-paclitaxel [n=1]) and one (<1%) patient in the placebo group (hepatic failure).,"['patients with unresectable, locally advanced or metastatic triple-negative breast cancer', 'Between June 23, 2015, and May 24, 2017, 902 patients were enrolled, of whom 451', 'unresectable, locally advanced or metastatic triple-negative breast cancer (IMpassion130', 'patients with PD-L1 immune cell-positive metastatic triple-negative breast cancer', 'patients with PD-L1 immune cell-positive disease', '246 academic centres and community oncology practices in 41 countries, patients aged 18 years or older, with previously untreated, histologically documented, locally advanced or metastatic triple-negative breast cancer, and Eastern Cooperative Oncology Group performance status of 0 or 1 were eligible']","['atezolizumab plus nab-paclitaxel', 'atezolizumab', 'Atezolizumab plus nab-paclitaxel', 'placebo', 'permuted block method (block size of four) and an interactive voice-web response system', 'placebo plus nab-paclitaxel', 'atezolizumab 840 mg or matching placebo']","['peripheral neuropathy', 'investigator-assessed progression-free survival per Response Evaluation Criteria in Solid Tumors version 1.1 and overall survival', 'efficacy and safety', 'septic shock', 'overall survival', 'median overall survival', 'neutropenia', 'Median overall survival', 'neutrophil count', 'deaths', 'fatigue', 'final progression-free survival results']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C3539878', 'cui_str': 'Triple Negative Breast Cancer'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count (procedure)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",902.0,0.735947,Treatment-related deaths occurred in two (<1%) patients in the atezolizumab group (autoimmune hepatitis related to atezolizumab [n=1] and septic shock related to nab-paclitaxel [n=1]) and one (<1%) patient in the placebo group (hepatic failure).,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schmid', 'Affiliation': 'Barts Cancer Institute, Queen Mary University of London, London, UK. Electronic address: p.schmid@qmul.ac.uk.'}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'University of California San Francisco Comprehensive Cancer Center, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Adams', 'Affiliation': 'Perlmutter Cancer Center, New York University Langone Medical Center, New York, NY, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schneeweiss', 'Affiliation': 'National Center for Tumor Diseases, Heidelberg University Hospital and German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Carlos H', 'Initials': 'CH', 'LastName': 'Barrios', 'Affiliation': 'Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil; Latin American Cooperative Oncology Group, Porto Alegre, Brazil; Grupo Oncoclínicas, Porto Alegre, Brazil.'}, {'ForeName': 'Hiroji', 'Initials': 'H', 'LastName': 'Iwata', 'Affiliation': 'Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Diéras', 'Affiliation': 'Department of Medical Oncology, Institut Curie, Paris, France; Department of Medical Oncology, Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'Volkmar', 'Initials': 'V', 'LastName': 'Henschel', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Molinero', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Stephen Y', 'Initials': 'SY', 'LastName': 'Chui', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Vidya', 'Initials': 'V', 'LastName': 'Maiya', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Amreen', 'Initials': 'A', 'LastName': 'Husain', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Winer', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Sherene', 'Initials': 'S', 'LastName': 'Loi', 'Affiliation': 'Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Leisha A', 'Initials': 'LA', 'LastName': 'Emens', 'Affiliation': 'University of Pittsburgh Medical Center Hillman Cancer Center, Pittsburgh, PA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30689-8']
1210,31774526,Association of Obesity With Septic Complications After Major Abdominal Surgery: A Secondary Analysis of the RELIEF Randomized Clinical Trial.,"Importance


Body mass index (BMI) has been the most common obesity measure to assess perioperative risk; however, cardiometabolic risk is associated with the burden of visceral fat. Definitive evidence on the association of visceral fat measures, such as waist circumference and waist-to-hip ratio (WHR), with postoperative complications is lacking.
Objective


To compare the value of waist circumference with the value WHR and BMI in predicting adverse outcomes, including major septic complications and persistent disability, following major abdominal surgery.
Design, Setting, and Participants


This planned secondary analysis of the Restrictive vs Liberal Fluid Therapy for Major Abdominal Surgery (RELIEF) randomized clinical trial took place at 47 centers in 7 countries between October 2013 and September 2016, with 90-day follow-up. A total of 2954 adult RELIEF participants were coenrolled in this secondary analysis. Data analysis took place from December 2018 to September 2019.
Exposures


Waist circumference, WHR, and BMI measurements.
Main Outcomes and Measures


The primary outcomes were 30-day major septic complications and 90-day persistent disability or death.
Results


Of 2954 eligible participants, 2755 were included (mean [SD] age, 65.9 [12.9] years; 1426 [51.8%] men) in the final analysis. A total of 564 participants (20.6%) experienced at least 1 major septic complication within 30 days after surgery (sepsis, 265 [9.7%]; surgical site infection, 409 [14.9%]; anastomotic leak, 78 [2.8%]; pneumonia, 104 [3.8%]). Waist circumference had a statistically significantly larger odds ratio (OR) and discrimination indices as well as a smaller prediction error than WHR or BMI for 30-day major septic complications or death (waist circumference: OR, 1.44; 95% CI, 1.28-1.62; P < .001; area under the receiver operating characteristic curve, 0.641; net reclassification index, 0.266; integrated discrimination improvement [score × 104], 152.98; Brier score, 0.162; WHR: OR, 1.15; 95% CI, 1.03-1.28; P = .01; area under the receiver operating characteristic curve, 0.621; net classification index, 0.199; integrated discrimination improvement [score × 104], 28.47; Brier score, 0.164; BMI: OR, 1.33; 95% CI, 1.17-1.50; P < .001; area under the receiver operating characteristic curve, 0.629; net reclassification index, 0.205; integrated discrimination improvement [score × 104], 85.61; Brier score, 0.163) but not for any other outcomes.
Conclusions and Relevance


In this secondary analysis of the RELIEF randomized clinical trial, waist circumference was observed to be superior to other adiposity indices in predicting 30-day major septic complications alone or in conjunction with death following elective major abdominal surgery. Findings suggest that waist circumference is a useful adiposity measure that should be incorporated in preoperative risk assessment for such complications.
Trial Registration


ClinicalTrials.gov identifier: NCT01424150.",2019,"Waist circumference had a statistically significantly larger odds ratio (OR) and discrimination indices as well as a smaller prediction error than WHR or BMI for 30-day major septic complications or death (waist circumference: OR, 1.44; 95% CI, 1.28-1.62; P < .001; area under the receiver operating characteristic curve, 0.641; net reclassification index, 0.266; integrated discrimination improvement [score × 104], 152.98; Brier score, 0.162; WHR: OR, 1.15; 95% CI, 1.03-1.28; P = .01; area under the receiver operating characteristic curve, 0.621; net classification index, 0.199; integrated discrimination improvement [score × 104], 28.47; Brier score, 0.164; BMI: OR, 1.33; 95% CI, 1.17-1.50; P < .001; area under the receiver operating characteristic curve, 0.629; net reclassification index, 0.205; integrated discrimination improvement [score × 104], 85.61; Brier score, 0.163) but not for any other outcomes.
","['2954 eligible participants, 2755 were included (mean [SD] age, 65.9 [12.9] years; 1426 [51.8', 'Major Abdominal Surgery (RELIEF) randomized clinical trial took place at 47 centers in 7 countries between October 2013 and September 2016, with 90-day follow-up', '2954 adult RELIEF participants', 'After Major Abdominal Surgery']",['Restrictive vs Liberal Fluid Therapy'],"['anastomotic leak', 'Waist circumference', 'larger odds ratio (OR) and discrimination indices', 'Obesity With Septic Complications', 'septic complication', 'surgical site infection', 'Exposures\n\n\nWaist circumference, WHR, and BMI measurements', '30-day major septic complications and 90-day persistent disability or death', 'waist circumference and waist-to-hip ratio (WHR']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0206034', 'cui_str': 'Clinical Trials, Randomized'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}]","[{'cui': 'C0016286', 'cui_str': 'Fluid Therapy'}]","[{'cui': 'C0919691', 'cui_str': 'Anastomotic Leakage'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205682', 'cui_str': 'Waist-Hip Ratio'}]",2954.0,0.302775,"Waist circumference had a statistically significantly larger odds ratio (OR) and discrimination indices as well as a smaller prediction error than WHR or BMI for 30-day major septic complications or death (waist circumference: OR, 1.44; 95% CI, 1.28-1.62; P < .001; area under the receiver operating characteristic curve, 0.641; net reclassification index, 0.266; integrated discrimination improvement [score × 104], 152.98; Brier score, 0.162; WHR: OR, 1.15; 95% CI, 1.03-1.28; P = .01; area under the receiver operating characteristic curve, 0.621; net classification index, 0.199; integrated discrimination improvement [score × 104], 28.47; Brier score, 0.164; BMI: OR, 1.33; 95% CI, 1.17-1.50; P < .001; area under the receiver operating characteristic curve, 0.629; net reclassification index, 0.205; integrated discrimination improvement [score × 104], 85.61; Brier score, 0.163) but not for any other outcomes.
","[{'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Gurunathan', 'Affiliation': 'Department of Anaesthesia and Perfusion Services, The Prince Charles Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Ivan L', 'Initials': 'IL', 'LastName': 'Rapchuk', 'Affiliation': 'Department of Anaesthesia and Perfusion Services, The Prince Charles Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Marilla', 'Initials': 'M', 'LastName': 'Dickfos', 'Affiliation': 'Department of Anaesthesia and Perfusion Services, The Prince Charles Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Larsen', 'Affiliation': 'Department of Anaesthesia and Perfusion Services, The Prince Charles Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Forbes', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Martin', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Leslie', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Myles', 'Affiliation': 'Department of Anaesthesiology and Perioperative Medicine, Alfred Hospital and Monash University, Melbourne, Victoria, Australia.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.16345']
1211,31765987,"A multicenter, phase I/II trial of biweekly S-1, leucovorin, oxaliplatin and gemcitabine in metastatic pancreatic adenocarcinoma-TCOG T1211 study.","BACKGROUND


This phase I/II study evaluated the feasibility and efficacy of S-1, leucovorin, oxaliplatin and gemcitabine (SLOG), a triplet regimen, for treating patients with metastatic pancreatic ductal adenocarcinoma (PDAC).
METHODS


Patients with chemo-naive, metastatic PDAC were eligible to receive fixed-rate infusion (10 mg/m 2 /min) of gemcitabine of 800 mg/m 2  followed by oxaliplatin of 85 mg/m 2  on day 1 plus oral S-1 and leucovorin (20 mg/m 2 ) twice daily from days 1 to 7 in a 2-week cycle. The dose of S-1 would be escalated from 20, 30, 35 to 40 mg/m2 in a 3 + 3 designed phase I part to determine the maximum tolerated dose (MTD) for phase II study, in which the primary end-point was objective response rate (ORR). The recommended dose of S-1 was from phase I. This trial is registered at ClinicalTrials.gov: NCT01415713.
RESULTS


Seventy-three patients were enrolled. In the phase I study (n = 19), the MTD of S-1 was 35 mg/m 2  twice daily. Of 54 patients in phase II, the ORR was 40.7% (95% confidence interval [CI], 28%-55%). The median progression-free survival and overall survival were 7.6 (95% CI, 5.6-11.0) and 11.4 (95% CI, 8.1-16.3) months, respectively. The most common grade III/IV adverse event was neutropenia (40.7%). Twenty-four percent of patients had SLOG treatment for more than 1 year. The mean relative dose intensities of gemcitabine, oxaliplatin, and S-1 were 92%, 92% and 89%, respectively.
CONCLUSION


Biweekly SLOG is a feasible regimen with promising activity and safety profiles. A randomised study comparing SLOG versus modified folinic acid, fluorouracil, irinotecan, and oxaliplatin (FOLFIRINOX) in advanced PDAC is ongoing (ClinicalTrials.gov: NCT03443492).",2020,"The median progression-free survival and overall survival were 7.6 (95% CI, 5.6-11.0) and 11.4 (95% CI, 8.1-16.3) months, respectively.","['Patients with chemo-naive, metastatic PDAC were eligible to receive', 'metastatic pancreatic adenocarcinoma-TCOG T1211 study', 'Seventy-three patients were enrolled', 'patients with metastatic pancreatic ductal adenocarcinoma (PDAC']","['S-1, leucovorin, oxaliplatin and gemcitabine', 'fixed-rate infusion (10\xa0mg/m 2 /min) of gemcitabine of 800\xa0mg/m 2  followed by 85\xa0mg/m oxaliplatin of 85\xa0mg/m 2  on day 1 plus oral S-1 and leucovorin', 'SLOG versus modified folinic acid, fluorouracil, irinotecan, and oxaliplatin (FOLFIRINOX', 'S-1, leucovorin, oxaliplatin and gemcitabine (SLOG']","['median progression-free survival and overall survival', 'ORR', 'mean relative dose intensities of gemcitabine, oxaliplatin, and S-1', 'objective response rate (ORR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0281361', 'cui_str': 'Adenocarcinoma of pancreas'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}]","[{'cui': 'C0879262', 'cui_str': 'TS-1 cpd'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0702093', 'cui_str': '/min'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0879262', 'cui_str': 'TS-1 cpd'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}]",73.0,0.0688427,"The median progression-free survival and overall survival were 7.6 (95% CI, 5.6-11.0) and 11.4 (95% CI, 8.1-16.3) months, respectively.","[{'ForeName': 'Nai-Jung', 'Initials': 'NJ', 'LastName': 'Chiang', 'Affiliation': 'Institute of Clinical Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan; National Institute of Cancer Research, National Health Research Institutes, Tainan, Taiwan; Division of Hematology and Oncology, Department of Internal Medicine, National Cheng Kung University Hospital, Tainan, Taiwan.'}, {'ForeName': 'Kelvin K', 'Initials': 'KK', 'LastName': 'Tsai', 'Affiliation': 'National Institute of Cancer Research, National Health Research Institutes, Tainan, Taiwan; Graduate Institute of Clinical Medicine, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Chin-Fu', 'Initials': 'CF', 'LastName': 'Hsiao', 'Affiliation': 'Institute of Population Health Sciences, National Health Research Institutes, Zhunan, Taiwan.'}, {'ForeName': 'Shih-Hung', 'Initials': 'SH', 'LastName': 'Yang', 'Affiliation': 'Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan; Graduate Institute of Oncology, College of Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Hui-Hua', 'Initials': 'HH', 'LastName': 'Hsiao', 'Affiliation': 'Department of Internal Medicine, Kaohsiung Medical University Hospital and Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Wen-Chi', 'Initials': 'WC', 'LastName': 'Shen', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Linkou Chang Gung Memorial Hospital and Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Chiun', 'Initials': 'C', 'LastName': 'Hsu', 'Affiliation': 'Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan; Graduate Institute of Oncology, College of Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Yu-Lin', 'Initials': 'YL', 'LastName': 'Lin', 'Affiliation': 'Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan; Graduate Institute of Oncology, College of Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Jen-Shi', 'Initials': 'JS', 'LastName': 'Chen', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Linkou Chang Gung Memorial Hospital and Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Yan-Shen', 'Initials': 'YS', 'LastName': 'Shan', 'Affiliation': 'Institute of Clinical Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Department of Surgery, National Cheng Kung University Hospital, Tainan, Taiwan.'}, {'ForeName': 'Li-Tzong', 'Initials': 'LT', 'LastName': 'Chen', 'Affiliation': 'National Institute of Cancer Research, National Health Research Institutes, Tainan, Taiwan; Division of Hematology and Oncology, Department of Internal Medicine, National Cheng Kung University Hospital, Tainan, Taiwan; Department of Internal Medicine, Kaohsiung Medical University Hospital and Kaohsiung Medical University, Kaohsiung, Taiwan. Electronic address: leochen@nhri.org.tw.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.10.023']
1212,31185775,"The Effects of Virtual Kayak Paddling Exercise on Postural Balance, Muscle Performance, and Cognitive Function in Older Adults with Mild Cognitive Impairment: A Randomized Controlled Trial.","Deterioration of physical and psychological health is an important issue in older adults aged 65 years or more. This study aimed to determine whether a virtual kayak paddling (VKP) exercise could improve postural balance, muscle performance, and cognitive function in older adults with mild cognitive impairment. Sixty participants were randomly assigned to the VKP ( n  = 30) or control group ( n  = 30). Participants in the VKP group performed the paddling exercise in a virtual environment for 60 min twice a week for 6 weeks, whereas those in the control group performed home exercises. Postural balance ( p  < .05), muscle performance ( p  < .05), and cognitive function ( p  < .05) were significantly improved in the VKP group and were superior to those in the control group ( p  < .05). Thus, the findings indicate that VKP exercise improves postural balance, muscle performance, and cognitive function in older adults with mild cognitive impairment.",2019,"Postural balance ( p  < .05), muscle performance ( p  < .05), and cognitive function ( p  < .05) were significantly improved in the VKP group and were superior to those in the control group ( p  < .05).","['older adults with mild cognitive impairment', 'older adults aged 65 years or more', 'Sixty participants', 'Older Adults with Mild Cognitive Impairment']","['control group performed home exercises', 'virtual kayak paddling (VKP) exercise', 'VKP', 'Virtual Kayak Paddling Exercise', 'VKP exercise', 'paddling exercise']","['cognitive function', 'Postural Balance, Muscle Performance, and Cognitive Function', 'Postural balance', 'postural balance, muscle performance, and cognitive function', 'muscle performance', 'Deterioration of physical and psychological health']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4316800', 'cui_str': 'Kayaking'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C1256755', 'cui_str': 'Postural Equilibrium'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",60.0,0.0205344,"Postural balance ( p  < .05), muscle performance ( p  < .05), and cognitive function ( p  < .05) were significantly improved in the VKP group and were superior to those in the control group ( p  < .05).","[{'ForeName': 'Wonjae', 'Initials': 'W', 'LastName': 'Choi', 'Affiliation': ''}, {'ForeName': 'Seungwon', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2018-0020']
1213,31487718,NIV NAVA versus Nasal CPAP in Premature Infants: A Randomized Clinical Trial.,"BACKGROUND


Noninvasive ventilation is recommended for neonatal respiratory distress to avoid adverse effects of invasive ventilation.
OBJECTIVE


The aim of this study was to compare the feasibility of noninvasive neurally adjusted ventilatory assist (NIV NAVA) and continuous positive airway pressure (CPAP) in preterm newborn infants.
METHODS


Forty preterm infants (gestational age 28+0 to 36+6 weeks) requiring CPAP and supplemental oxygen (FiO2 >0.23) for respiratory distress at <48 h of postnatal age were randomized to NIV NAVA or CPAP. The primary endpoint was the inspired oxygen concentration 12 h after study inclusion. Secondary endpoints were the duration of oxygen treatment, total duration of respiratory support, parenteral nutrition, blood gas values, patient comfort, need for invasive ventilation, and treatment complications.
RESULTS


The mean FiO2 at the time of study inclusion was 0.29 in both groups. After 12 h of treatment, FiO2 was 0.26 ± 0.07 and 0.26 ± 0.04 in the NIV NAVA and CPAP groups, respectively (difference 0.006, 95% CI -0.4 to 0.5), with no difference between the groups during the course of noninvasive ventilation (p = 0.80). Seven patients (35%) in the NIV NAVA group and 10 (50%) in the control group required intubation (difference 15%, 95% CI -15.5 to 4.3, p = 0.36). Time to intubation, gas exchange, vital parameters, pain scale, treatment complications, and neonatal outcome did not differ between the groups.
CONCLUSIONS


In the present trial, NIV NAVA had no statistically significant effect on oxygen requirements or the need for invasive ventilation in preterm newborn infants.",2019,"Time to intubation, gas exchange, vital parameters, pain scale, treatment complications, and neonatal outcome did not differ between the groups.
","['Forty preterm infants (gestational age 28+0 to 36+6 weeks) requiring CPAP and supplemental oxygen (FiO2 >0.23) for respiratory distress at <48 h of postnatal age', 'preterm newborn infants', 'Premature Infants']","['NIV NAVA or CPAP', 'NIV NAVA versus Nasal CPAP', 'noninvasive neurally adjusted ventilatory assist (NIV NAVA) and continuous positive airway pressure (CPAP']","['Time to intubation, gas exchange, vital parameters, pain scale, treatment complications, and neonatal outcome', 'inspired oxygen concentration', 'mean FiO2', 'intubation', 'oxygen requirements', 'duration of oxygen treatment, total duration of respiratory support, parenteral nutrition, blood gas values, patient comfort, need for invasive ventilation, and treatment complications']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress (finding)'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C3665969', 'cui_str': 'Nasal CPAP'}, {'cui': 'C3178854', 'cui_str': 'Neurally Adjusted Ventilatory Assist'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0442732', 'cui_str': 'Vital (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0428648', 'cui_str': 'Inspired oxygen concentration (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0030547', 'cui_str': 'Parenteral Nutrition'}, {'cui': 'C0005800', 'cui_str': 'Blood Gas Analysis'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}]",12.0,0.253031,"Time to intubation, gas exchange, vital parameters, pain scale, treatment complications, and neonatal outcome did not differ between the groups.
","[{'ForeName': 'Merja', 'Initials': 'M', 'LastName': 'Kallio', 'Affiliation': 'PEDEGO Research Unit, Medical Research Center Oulu, University of Oulu, Oulu, Finland, merja.kallio@oulu.fi.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Mahlman', 'Affiliation': 'PEDEGO Research Unit, Medical Research Center Oulu, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Koskela', 'Affiliation': 'PEDEGO Research Unit, Medical Research Center Oulu, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Outi', 'Initials': 'O', 'LastName': 'Aikio', 'Affiliation': 'PEDEGO Research Unit, Medical Research Center Oulu, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Suo-Palosaari', 'Affiliation': 'Research Unit of Medical Imaging, Physics and Technology, Department of Diagnostic Radiology, Faculty of Medicine, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Tytti', 'Initials': 'T', 'LastName': 'Pokka', 'Affiliation': 'PEDEGO Research Unit, Medical Research Center Oulu, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Saarela', 'Affiliation': 'PEDEGO Research Unit, Medical Research Center Oulu, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Hallman', 'Affiliation': 'PEDEGO Research Unit, Medical Research Center Oulu, University of Oulu, Oulu, Finland.'}]",Neonatology,['10.1159/000502341']
1214,31911524,Preoperative POPQ versus Simulated Apical Support as a Guideline for Anterior or Posterior Repair at the Time of Transvaginal Apical Suspension (PREPARE trial): study protocol for a randomised controlled trial.,"INTRODUCTION


Transvaginal reconstructive surgery is the mainstay of treatment for symptomatic pelvic organ prolapse. Although adequate support for the vaginal apex is considered essential for durable surgical repair, the optimal management of anterior and posterior vaginal wall prolapse in women undergoing transvaginal apical suspension remains unclear. The objective of this trial is to compare surgical outcomes of pelvic organ prolapse quantification (POPQ)-based surgery with outcomes of simulated apical support-based surgery for anterior or posterior vaginal wall prolapse at the time of transvaginal apical suspension.
METHODS AND ANALYSIS


This is a randomised, multicentre, non-inferiority trial. While women who are assigned to the POPQ-based surgery group will undergo anterior or posterior colporrhaphy for all stage 2 or greater anterior or posterior vaginal prolapse, those assigned to simulated apical support-based surgery will receive anterior or posterior colporrhaphy only for the prolapse unresolved under simulated apical support. The primary outcome measure is the composite surgical success, defined as the absence of anatomical (anterior or posterior vaginal descent beyond the hymen or descent of the vaginal apex beyond the half-way point of vagina) or symptomatic (the presence of vaginal bulge symptoms) recurrence or retreatment for prolapse by either surgery or pessary, at 2 years after surgery. Secondary outcomes include the rates of anterior or posterior colporrhaphy, the changes in anatomical outcomes, condition-specific quality of life and sexual function, perioperative outcomes and adverse events.
ETHICS AND DISSEMINATION


This study was approved by the institutional review board of each participating centre (Seoul National University College of Medicine/Seoul National University Hospital, Chonnam National University Hospital, Seoul St. Mary's Hospital, International St. Mary's Hospital). The results of the study will be published in peer-reviewed journals, and the findings will be presented at scientific meetings.
TRIAL REGISTRATION NUMBER


NCT03187054.",2020,"The primary outcome measure is the composite surgical success, defined as the absence of anatomical (anterior or posterior vaginal descent beyond the hymen or descent of the vaginal apex beyond the half-way point of vagina) or symptomatic (the presence of vaginal bulge symptoms) recurrence or retreatment for prolapse by either surgery or pessary, at 2 years after surgery.","[""participating centre (Seoul National University College of Medicine/Seoul National University Hospital, Chonnam National University Hospital, Seoul St. Mary's Hospital, International St. Mary's Hospital"", 'symptomatic pelvic organ prolapse']","['POPQ-based surgery group will undergo anterior or posterior colporrhaphy for all stage 2 or greater anterior or posterior vaginal prolapse, those assigned to simulated apical support-based surgery will receive anterior or posterior colporrhaphy', 'Transvaginal reconstructive surgery', 'pelvic organ prolapse quantification (POPQ)-based surgery with outcomes of simulated apical support-based surgery for anterior or posterior vaginal wall prolapse']","['rates of anterior or posterior colporrhaphy, the changes in anatomical outcomes, condition-specific quality of life and sexual function, perioperative outcomes and adverse events', 'composite surgical success, defined as the absence of anatomical (anterior or posterior vaginal descent beyond the hymen or descent of the vaginal apex beyond the half-way point of vagina) or symptomatic (the presence of vaginal bulge symptoms) recurrence or retreatment for prolapse']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0454888', 'cui_str': 'St. Marys (geographic location)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0877015', 'cui_str': 'Urogenital Prolapse'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0195230', 'cui_str': 'Posterior repair of vagina (procedure)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0205990', 'cui_str': 'Vaginal Prolapse'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205111', 'cui_str': 'Apical (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach (qualifier value)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0877015', 'cui_str': 'Urogenital Prolapse'}, {'cui': 'C0425853', 'cui_str': 'Posterior vaginal wall prolapse (disorder)'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0195230', 'cui_str': 'Posterior repair of vagina (procedure)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0020412', 'cui_str': 'Hymen'}, {'cui': 'C0227794', 'cui_str': 'Structure of fornix of vagina'}, {'cui': 'C0042232', 'cui_str': 'Vagina'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}]",,0.141242,"The primary outcome measure is the composite surgical success, defined as the absence of anatomical (anterior or posterior vaginal descent beyond the hymen or descent of the vaginal apex beyond the half-way point of vagina) or symptomatic (the presence of vaginal bulge symptoms) recurrence or retreatment for prolapse by either surgery or pessary, at 2 years after surgery.","[{'ForeName': 'Myung Jae', 'Initials': 'MJ', 'LastName': 'Jeon', 'Affiliation': 'Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Republic of Korea jeonmj@snu.ac.kr.'}, {'ForeName': 'Chul Hong', 'Initials': 'CH', 'LastName': 'Kim', 'Affiliation': 'Obstetrics and Gynecology, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Hyun-Hee', 'Initials': 'HH', 'LastName': 'Cho', 'Affiliation': ""Obstetrics and Gynecology, The Catholic University of Korea, Eunpyeong St. Mary's Hospital, Seoul, Republic of Korea.""}, {'ForeName': 'Dong Hoon', 'Initials': 'DH', 'LastName': 'Suh', 'Affiliation': 'Obstetrics and Gynecology, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Soo Rim', 'Initials': 'SR', 'LastName': 'Kim', 'Affiliation': ""Obstetrics and Gynecology, International St. Mary's Hospital, Catholic Kwandong University College of Medicine, Incheon, Republic of Korea.""}]",BMJ open,['10.1136/bmjopen-2019-034170']
1215,31622732,A Randomized-Controlled Phase 2 Study of the MET Antibody Emibetuzumab in Combination with Erlotinib as First-Line Treatment for EGFR Mutation-Positive NSCLC Patients.,"INTRODUCTION


The hepatocyte growth factor receptor mesenchymal-epithelial transition (MET) is reported to be a negative prognostic marker in EGFR-mutant NSCLC and involved in resistance to EGFR inhibitors. Emibetuzumab, a humanized immunoglobulin G4 monoclonal bivalent MET antibody, blocks ligand-dependent and ligand-independent hepatocyte growth factor/MET signaling. This phase 2 study compared erlotinib with and without emibetuzumab in first-line treatment of EGFR-mutant metastatic NSCLC.
METHODS


Patients with stage IV EGFR-mutant NSCLC and disease control after an 8-week lead-in with erlotinib (150 mg daily) were randomized to continue taking erlotinib with or without emibetuzumab (750 mg every 2 weeks). The primary end point was progression-free survival (PFS). Additional end points included overall survival, overall response rate, safety, pharmacokinetics, and exploratory analysis of MET expression.
RESULTS


No significant difference in median PFS was observed in the intent-to-treat population (9.3 months with emibetuzumab + erlotinib versus 9.5 months with erlotinib monotherapy [hazard ratio (HR) = 0.89, 90% confidence interval (CI): 0.64-1.23]). The median overall survival was 34.3 months with emibetuzumab plus erlotinib versus 25.4 months with erlotinib (HR = 0.74, 90% CI: 0.49-1.11). Emibetuzumab plus erlotinib was well tolerated, with peripheral edema and mucositis as the only adverse events occurring 10% or more frequently relative to erlotinib. Exploratory post hoc analysis showed an improvement of 15.3 months in median PFS for the 24 patients with the highest MET expression (MET expression level of 3+ in ≥90% of tumor cells) (20.7 with emibetuzumab + erlotinib versus 5.4 months with erlotinib [HR = 0.39, 90% CI: 0.17-0.91]).
CONCLUSIONS


No statistically significant difference in PFS was noted in the intent-to-treat population. Exploratory analysis confirmed that high MET expression is a negative prognostic marker for patients treated with erlotinib, indicating that emibetuzumab plus erlotinib may provide clinically meaningful benefit.",2020,Median OS was 34.3 months for emibetuzumab+erlotinib and 25.4 months for erlotinib (HR = 0.74; 90% CI: 0.49-1.11).,"['EGFR-mutation Positive NSCLC Patients', 'Patients with Stage IV EGFR-mutant NSCLC and disease control following an 8-week lead-in with', '24 patients with highest MET expression (MET 3+ in ≥90% of tumor cells']","['erlotinib (150 mg QD', 'erlotinib±emibetuzumab', 'continue erlotinib with or without emibetuzumab', 'Emibetuzumab', 'Emibetuzumab+erlotinib']","['tolerated with peripheral edema and mucositis', 'overall survival (OS), overall response rate, safety, pharmacokinetics, and exploratory analysis of MET expression', 'median PFS', 'progression-free survival (PFS', 'PFS', 'Median OS']","[{'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C3179739', 'cui_str': '(LaCit2)3+'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant (morphologic abnormality)'}]","[{'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C0085649', 'cui_str': 'Peripheral edema (morphologic abnormality)'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0298044,Median OS was 34.3 months for emibetuzumab+erlotinib and 25.4 months for erlotinib (HR = 0.74; 90% CI: 0.49-1.11).,"[{'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Scagliotti', 'Affiliation': 'Department of Oncology, Università degli Studi di Torino, Orbassano, Italy. Electronic address: giorgio.scagliotti@unito.it.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Moro-Sibilot', 'Affiliation': 'CHU Grenoble-Alpes, Oncologie Thoracique, Grenoble, France.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kollmeier', 'Affiliation': 'Lungenklinik Heckeshorn, Helios Klinikum Emil von Behring, Berlin, Germany.'}, {'ForeName': 'Adolfo', 'Initials': 'A', 'LastName': 'Favaretto', 'Affiliation': 'Medical Oncology, Azienda ULSS 2 Marca Trevigiana, Treviso, Italy.'}, {'ForeName': 'Eun Kyung', 'Initials': 'EK', 'LastName': 'Cho', 'Affiliation': 'Gachon University Gil Hospital, Incheon, Republic of Korea.'}, {'ForeName': 'Heidrun', 'Initials': 'H', 'LastName': 'Grosch', 'Affiliation': 'Thoraxklinik Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kimmich', 'Affiliation': 'Klinik Schillerhöhe, Gerlingen, Germany.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Girard', 'Affiliation': 'Institute of Thorax Curie Montsouris, Curie Institute, Paris, France.'}, {'ForeName': 'Chun-Ming', 'Initials': 'CM', 'LastName': 'Tsai', 'Affiliation': 'Taipei Veterans General Hospital, Taipei, Republic of China.'}, {'ForeName': 'Te-Chun', 'Initials': 'TC', 'LastName': 'Hsia', 'Affiliation': 'China Medical University, Taichung, Republic of China.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Brighenti', 'Affiliation': 'Oncology Department, Cremona Hospital Institutes, Cremona, Italy.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schumann', 'Affiliation': 'Hospital association Kempten-Oberallgäu, University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Xuejing Aimee', 'Initials': 'XA', 'LastName': 'Wang', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Sameera R', 'Initials': 'SR', 'LastName': 'Wijayawardana', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Gruver', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Wallin', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Kambiz', 'Initials': 'K', 'LastName': 'Mansouri', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Wacheck', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Gee-Chen', 'Initials': 'GC', 'LastName': 'Chang', 'Affiliation': 'Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Republic of School of Medicine, National Yang-Ming University, Taipei, Republic of China.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2019.10.003']
1216,31188705,The Role of Self-Determination in Changing Physical Activity Behavior in People Diagnosed With Bowel Polyps: A Pilot Randomized Controlled Trial.,"This nonblinded randomized controlled trial investigated the efficacy of a physical activity (PA) intervention underpinned by self-determination theory. Participants (N = 31, mean age 69 years [SD = 4.9]) diagnosed with bowel polyps were randomized to an active lifestyle program (ALP; n = 17) or standard care (n = 14). ALP received supervised exercise and counseling for 6 months. Both groups were followed up at 12 months. Outcomes were change in PA and behavioral regulation. Data were analyzed with intention to treat. At 6 months, differences were observed for behavioral regulation in favor of ALP (p < .05). PA differences were significant for leisure, walking, and vigorous in favor of ALP (p < .05). The self-determination theory can be an effective strategy for promoting PA behavior change in this population, but a larger trial is needed to further explore the utility of the self-determination theory in this context.",2020,"PA differences were significant for leisure, walking, and vigorous in favour of ALP (P<0.05).
","['Participants (n=31, mean age 69y [SD= 4.9]) diagnosed with bowel polyps', 'People Diagnosed With Bowel Polyps']","['Self Determination', 'physical activity (PA) intervention underpinned by Self-Determination Theory (SDT', 'active lifestyle programme (ALP; N= 17) or standard care (SC', 'SDT']","['PA and behavioural regulation', 'leisure, walking, and vigorous in favour of ALP (P<0.05', 'behavioural regulation']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}]","[{'cui': 'C0036595', 'cui_str': 'Self Determination'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]",,0.101066,"PA differences were significant for leisure, walking, and vigorous in favour of ALP (P<0.05).
","[{'ForeName': 'Liane S', 'Initials': 'LS', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'Barnabas', 'Initials': 'B', 'LastName': 'Shaw', 'Affiliation': ''}, {'ForeName': 'Srijit', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': ''}, {'ForeName': 'Pryscilla', 'Initials': 'P', 'LastName': 'Dieguez', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hernon', 'Affiliation': ''}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Belshaw', 'Affiliation': ''}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Saxton', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2018-0279']
1217,31769596,A randomized study showing improved skin quality and aesthetic appearance of dorsal hands after hyaluronic acid gel treatment in a Chinese population.,"BACKGROUND


Patients are increasingly aware of the aesthetic appearance of aging hands.
AIMS


To evaluate efficacy and safety of a hyaluronic acid gel for improving skin quality in aged skin of the dorsal hand.
METHODS


This was a 15-month randomized, multi-center, evaluator-blinded, split-hand, no treatment-controlled study. Three treatments with hyaluronic acid gel were administered in the same hand in adult Chinese subjects with grade 2 or 3 (mild or moderate aging) on the Hand Grading Scale (HGS). The primary objective was to evaluate the difference at 3 months between treated and untreated hands, based on the blinded evaluator's HGS assessment. Secondary assessments included the Global Aesthetic Improvement Scale (GAIS), biophysical measurements (skin elasticity, skin roughness and hydration), and subject satisfaction. Safety was evaluated by incidence of adverse events.
RESULTS


A total of 100 subjects were enrolled. Clinically relevant differences in HGS favored HA gel (P < .0001). At 15 months, 87%-96% of treated hands were still improved according to GAIS (per evaluator and subject, respectively). Objective measures of skin quality improved, confirmed by evaluators and highly satisfied subjects. Treatment was well tolerated.
CONCLUSIONS


Hyaluronic acid treatment improved skin quality and reduced the aging appearance of the hand, with high subject satisfaction.",2020,Clinically relevant differences in HGS favored HA gel (P < .0001).,"['adult Chinese subjects with grade 2 or 3 (mild or moderate aging) on the Hand Grading Scale (HGS', 'aged skin of the dorsal hand', 'a Chinese population', '100 subjects were enrolled']","['Hyaluronic acid', 'hyaluronic acid gel']","['Global Aesthetic Improvement Scale (GAIS), biophysical measurements (skin elasticity, skin roughness and hydration), and subject satisfaction', 'skin quality and aesthetic appearance of dorsal hands', 'skin quality', 'tolerated']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0222045'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0230372', 'cui_str': 'Structure of dorsum of hand'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C0222045'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0423761', 'cui_str': 'Skin elasticity (observable entity)'}, {'cui': 'C0859038', 'cui_str': 'Skin roughness'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0230372', 'cui_str': 'Structure of dorsum of hand'}]",100.0,0.0514832,Clinically relevant differences in HGS favored HA gel (P < .0001).,"[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Air Force General Hospital PLA, Beijing, China.'}, {'ForeName': 'Jinhua', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Fudan University Huashan Hospital, Shanghai, China.'}, {'ForeName': 'Shaomin', 'Initials': 'S', 'LastName': 'Zhong', 'Affiliation': 'Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Ruiyan', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Air Force General Hospital PLA, Beijing, China.'}, {'ForeName': 'Wenyu', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Fudan University Huashan Hospital, Shanghai, China.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13221']
1218,31776960,Tiaobu Xinshen Recipe () Improved Mild Cognitive Impairment of Alzheimer's Disease Patients with Xin (Heart) and Shen (Kidney) Deficiency.,"OBJECTIVE


To observe the intervention effects of Tiaobu Xinshen Recipe (, TXR) on patients with mild cognitive impairment caused by Alzheimer's disease (MCI-AD).
METHODS


Totally 88 MCI-AD patients with syndrome of Xin (Heart) and Shen (Kidney) deficiency were assigned to the experimental group (47 cases, treated with TXR) and the control group (41 cases, treated with donepezil hydrochloride) using a random number table. Final recruited qualified patients were 44 cases in the experimental group and 39 cases in the control group. The therapeutic course was 12 weeks. Neuropsychological scales [mini mental state examination (MMSE) and Montreal cognitive assessment (MoCA)], and Chinese medicine (CM) dementia syndromes scales were performed in all patients, and results were compared between groups or intra-group before and after treatment.
RESULTS


MMSE and MoCA scores of the two groups were increased after treatment compared with those before treatment (P<0.05). But there was no statistical difference in MMSE or MOCA scores after treatment between the two groups (P>0.05). CM dementia syndrome score was significantly decreased after treatment in the experimental group compared with the control group (P<0.01). Visual spatial and executive function scores and delayed recall scores of the two groups were increased compared with those before treatment (P<0.01).
CONCLUSION


TXR could effectively improve cognitive impairment of MCI-AD patients with syndrome of Xin and Shen deficiency.",2020,"Visual spatial and executive function scores and delayed recall scores of the two groups were increased compared with those before treatment (P<0.01).
","[""Alzheimer's Disease Patients with Xin (Heart) and Shen (Kidney) Deficiency"", 'MCI-AD patients with syndrome of Xin and Shen deficiency', ""patients with mild cognitive impairment caused by Alzheimer's disease (MCI-AD"", 'Totally 88 MCI-AD patients with syndrome of Xin (Heart) and Shen (Kidney) deficiency', 'Final recruited qualified patients were 44 cases in the experimental group and 39 cases in the control group']","['donepezil hydrochloride', 'TXR', 'Tiaobu Xinshen Recipe (, TXR', 'Tiaobu Xinshen Recipe ']","['Neuropsychological scales [mini mental state examination (MMSE) and Montreal cognitive assessment (MoCA)], and Chinese medicine (CM) dementia syndromes scales', 'MMSE and MoCA scores', 'Visual spatial and executive function scores and delayed recall scores', 'MMSE or MOCA scores', 'Mild Cognitive Impairment', 'CM dementia syndrome score', 'cognitive impairment']","[{'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0911524', 'cui_str': 'AM 44'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0771848', 'cui_str': 'Donepezil hydrochloride'}, {'cui': 'C0600194', 'cui_str': 'Recipes'}]","[{'cui': 'C0222045'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C3496286'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}]",,0.0279449,"Visual spatial and executive function scores and delayed recall scores of the two groups were increased compared with those before treatment (P<0.01).
","[{'ForeName': 'Zhi-Ying', 'Initials': 'ZY', 'LastName': 'Lin', 'Affiliation': 'Department of Traditional Chinese Medicine, The Affiliated Union Hospital of Fujian Medical University, Fuzhou, 350001, China. lzy8426@126.com.'}, {'ForeName': 'Tian-Wen', 'Initials': 'TW', 'LastName': 'Huang', 'Affiliation': 'Department of Neurology, The Affiliated Union Hospital of Fujian Medical University, Fuzhou, 350001, China.'}, {'ForeName': 'Jun-Shang', 'Initials': 'JS', 'LastName': 'Huang', 'Affiliation': 'Key Laboratory of Traditional Chinese Medicine for the Treatment of Brain Dysfunction, Fujian Academy of Traditional Chinese Medicine, Fuzhou, 350001, China.'}, {'ForeName': 'Guan-Yi', 'Initials': 'GY', 'LastName': 'Zheng', 'Affiliation': 'Department of Traditional Chinese Medicine, The Affiliated Union Hospital of Fujian Medical University, Fuzhou, 350001, China.'}]",Chinese journal of integrative medicine,['10.1007/s11655-019-3073-z']
1219,31760487,Early mobilization versus plaster immobilization of simple elbow dislocations: a cost analysis of the FuncSiE multicenter randomized clinical trial.,"INTRODUCTION


The primary aim was to assess and compare the total costs (direct health care costs and indirect costs due to loss of production) after early mobilization versus plaster immobilization in patients with a simple elbow dislocation. It was hypothesized that early mobilization would not lead to higher direct and indirect costs.
MATERIALS AND METHODS


This study used data of a multicenter randomized clinical trial (FuncSiE trial). From August 25, 2009 until September 18, 2012, 100 adult patients with a simple elbow dislocation were recruited and randomized to early mobilization (immediate motion exercises; n = 48) or 3 weeks plaster immobilization (n = 52). Patients completed questionnaires on health-related quality of life [EuroQoL-5D (EQ-5D) and Short Form-36 (SF-36 PCS and SF-36 MCS)], health care use, and work absence. Follow-up was 1 year. Primary outcome were the total costs at 1 year. Analysis was by intention to treat.
RESULTS


There were no significant differences in EQ-5D, SF-36 PCS, and SF-36 MCS between the two groups. Mean total costs per patient were €3624 in the early mobilization group versus €7072 in the plaster group (p = 0.094). Shorter work absenteeism in the early mobilization group (10 versus 18 days; p = 0.027) did not lead to significantly lower costs for loss of productivity (€1719 in the early mobilization group versus €4589; p = 0.120).
CONCLUSION


From a clinical and a socio-economic point of view, early mobilization should be the treatment of choice for a simple elbow dislocation. Plaster immobilization has inferior results at almost double the cost.",2020,Mean total costs per patient were €3624 in the early mobilization group versus €7072 in the plaster group (p = 0.094).,"['patients with a simple elbow dislocation', 'From August 25, 2009 until September 18, 2012, 100 adult patients with a simple elbow dislocation']","['early mobilization (immediate motion exercises; n\u2009=\u200948) or 3\xa0weeks plaster immobilization', 'Early mobilization versus plaster immobilization of simple elbow dislocations', 'early mobilization versus plaster immobilization']","['total costs at 1\xa0year', 'health-related quality of life [EuroQoL-5D (EQ-5D) and Short Form-36 (SF-36 PCS and SF-36 MCS)], health care use, and work absence', 'Mean total costs', 'total costs (direct health care costs and indirect costs', 'EQ-5D, SF-36 PCS, and SF-36 MCS', 'loss of productivity', 'Shorter work absenteeism']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C2720437', 'cui_str': 'Dislocation of elbow joint (disorder)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0013459', 'cui_str': 'Early Mobilization'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0460977', 'cui_str': 'Plasters (physical object)'}, {'cui': 'C0020944', 'cui_str': 'Immobilization'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C2720437', 'cui_str': 'Dislocation of elbow joint (disorder)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C1689985', 'cui_str': 'Absence'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0439852', 'cui_str': 'Indirect (qualifier value)'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}]",100.0,0.199933,Mean total costs per patient were €3624 in the early mobilization group versus €7072 in the plaster group (p = 0.094).,"[{'ForeName': 'Esther M M', 'Initials': 'EMM', 'LastName': 'Van Lieshout', 'Affiliation': 'Trauma Research Unit, Department of Surgery, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands.'}, {'ForeName': 'Gijs I T', 'Initials': 'GIT', 'LastName': 'Iordens', 'Affiliation': 'Trauma Research Unit, Department of Surgery, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Polinder', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Eygendaal', 'Affiliation': 'Upper Limb Unit, Department of Orthopaedic Surgery, Amphia Hospital, P.O. Box 90158, 4800 RK, Breda, The Netherlands.'}, {'ForeName': 'Michael H J', 'Initials': 'MHJ', 'LastName': 'Verhofstad', 'Affiliation': 'Trauma Research Unit, Department of Surgery, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands.'}, {'ForeName': 'Niels W L', 'Initials': 'NWL', 'LastName': 'Schep', 'Affiliation': 'Trauma Unit, Department of Surgery, Academic Medical Center, P.O. Box 22660, 1100 DD, Amsterdam, The Netherlands.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Den Hartog', 'Affiliation': 'Trauma Research Unit, Department of Surgery, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands. d.denhartog@erasmusmc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Archives of orthopaedic and trauma surgery,['10.1007/s00402-019-03309-1']
1220,32492104,Exercise Electrocardiography and Computed Tomography Coronary Angiography for Patients With Suspected Stable Angina Pectoris: A Post Hoc Analysis of the Randomized SCOT-HEART Trial.,"Importance


Recent European guidance supports a diminished role for exercise electrocardiography (ECG) in the assessment of suspected stable angina.
Objective


To evaluate the utility of exercise ECG in contemporary practice and assess the value of combined functional and anatomical testing.
Design, Setting, and Participants


This is a post hoc analysis of the Scottish Computed Tomography of the Heart (SCOT-HEART) open-label randomized clinical trial, conducted in 12 cardiology chest pain clinics across Scotland for patients with suspected angina secondary to coronary heart disease. Between November 18, 2010, and September 24, 2014, 4146 patients aged 18 to 75 years with stable angina underwent clinical evaluation and 1417 of 1651 (86%) underwent exercise ECG prior to randomization. Statistical analysis was conducted from October 10 to November 5, 2019.
Interventions


Patients were randomized in a 1:1 ratio to receive standard care plus coronary computed tomography (CT) angiography or to receive standard care alone. The present analysis was limited to the 3283 patients who underwent exercise ECG alone or in combination with coronary CT angiography.
Main Outcomes and Measures


The primary clinical end point was death from coronary heart disease or nonfatal myocardial infarction at 5 years.
Results


Among the 3283 patients (1889 men; median age, 57.0 years [interquartile range, 50.0-64.0 years]), exercise ECG had a sensitivity of 39% and a specificity of 91% for detecting any obstructive coronary artery disease in those who underwent subsequent invasive angiography. Abnormal results of exercise ECG were associated with a 14.47-fold (95% CI, 10.00-20.41; P < .001) increase in coronary revascularization at 1 year and a 2.57-fold (95% CI, 1.38-4.63; P < .001) increase in mortality from coronary heart disease death at 5 years or in cases of nonfatal myocardial infarction at 5 years. Compared with exercise ECG alone, results of coronary CT angiography had a stronger association with 5-year coronary heart disease death or nonfatal myocardial infarction (hazard ratio, 10.63; 95% CI, 2.32-48.70; P = .002). The greatest numerical difference in outcome with CT angiography compared with exercise ECG alone was observed for those with inconclusive results of exercise ECG (6 of 283 [2%] vs 18 of 283 [6%]), although this was not statistically significant (log-rank P = .05).
Conclusions and Relevance


This study suggests that abnormal results of exercise ECG are associated with coronary revascularization and the future risk of adverse coronary events. However, coronary CT angiography more accurately detects coronary artery disease and is more strongly associated with future risk compared with exercise ECG.
Trial Registration


ClinicalTrials.gov Identifier: NCT01149590.",2020,"Compared with exercise ECG alone, results of coronary CT angiography had a stronger association with 5-year coronary heart disease death or nonfatal myocardial infarction (hazard ratio, 10.63; 95% CI, 2.32-48.70; P = .002).","['With Suspected Stable Angina Pectoris', 'Between November 18, 2010, and September 24, 2014, 4146 patients aged 18 to 75 years with stable angina underwent clinical evaluation and 1417 of 1651 (86%) underwent', 'Patients', '12 cardiology chest pain clinics across Scotland for patients with suspected angina secondary to coronary heart disease', '3283 patients who underwent', '3283 patients (1889 men; median age, 57.0 years [interquartile range, 50.0-64.0 years]), exercise ECG had a sensitivity of 39% and a specificity of 91% for detecting any obstructive coronary artery disease in those who underwent subsequent invasive angiography']","['coronary CT angiography', 'exercise ECG', 'Exercise Electrocardiography and Computed Tomography Coronary Angiography', 'exercise electrocardiography (ECG', 'exercise ECG alone or in combination with coronary CT angiography', 'CT angiography', 'standard care plus coronary computed tomography (CT) angiography or to receive standard care alone']","['mortality from coronary heart disease death', 'coronary revascularization', 'exercise ECG', 'death from coronary heart disease or nonfatal myocardial infarction at 5 years', '5-year coronary heart disease death or nonfatal myocardial infarction']","[{'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0439234', 'cui_str': 'year'}]",4146.0,0.139474,"Compared with exercise ECG alone, results of coronary CT angiography had a stronger association with 5-year coronary heart disease death or nonfatal myocardial infarction (hazard ratio, 10.63; 95% CI, 2.32-48.70; P = .002).","[{'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Singh', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Bing', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Dweck', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Edwin J R', 'Initials': 'EJR', 'LastName': 'van Beek', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Mills', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'Williams', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Villines', 'Affiliation': 'Division of Cardiovascular Medicine, University of Virginia, Charlottesville.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Adamson', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}]",JAMA cardiology,['10.1001/jamacardio.2020.1567']
1221,31759901,Educating Dutch General Practitioners in Dementia Advance Care Planning: A Cluster Randomized Controlled Trial.,"OBJECTIVES


Advance care planning (ACP) is seldom initiated with people with dementia (PWD) and mainly focuses on medical end-of-life decisions. We studied the effects of an educational intervention for general practitioners (GPs) aimed at initiating and optimizing ACP, with a focus on discussing medical and nonmedical preferences of future care.
DESIGN


A single-blinded cluster randomized controlled trial.
SETTING AND PARTICIPANTS


In 2016, 38 Dutch GPs (all from different practices) completed the study. They recruited 140 PWD, aged ≥65 years at any stage and with any type of dementia, from their practice.
METHODS


Intervention group GPs were trained in ACP, including shared decision-making and role-playing exercises. Control group GPs provided usual care. The primary outcome was ACP initiation: the proportion of PWD that had at least 1 ACP conversation documented in their medical file. Key secondary outcomes were the number of medical (ie, resuscitation, hospital admission) and nonmedical (ie, activities, social contacts) preferences discussed. At the 6-month follow-up, subjects' medical records were analyzed using random effect logistics and linear models with correction for GP clustering.
RESULTS


38 GP clusters (19 intervention; 19 control) included 140 PWD (intervention 73; control 67). Four PWD (2.9%) dropped out on the primary and key secondary outcomes. After 6 months, intervention group GPs initiated ACP with 35 PWD (49.3%), and control group GPs initiated ACP with 9 PWD (13.9%) [odds ratio (OR) 1.99; P = .002]. Intervention group GPs discussed 0.8 more medical [95% confidence interval (CI) 0.3, 1.3; P = .003] and 1.5 more nonmedical (95% CI 0.8, 2.3; P < .001) preferences per person with dementia than control group GPs.
CONCLUSIONS AND IMPLICATIONS


Our educational intervention increased ACP initiation, and the number of nonmedical and medical preferences discussed. This intervention has the potential to better align future care of PWD with their preferences but because of the short follow-up, the GPs' long-term adoption remains unknown.",2020,"Intervention group GPs discussed 0.8 more medical [95% confidence interval (CI) 0.3, 1.3; P = .003] and 1.5 more nonmedical (95% CI 0.8, 2.3; P < .001) preferences per person with dementia than control group GPs.
","['general practitioners (GPs', 'They recruited 140 PWD, aged ≥65\xa0years at any stage and with any type of dementia, from their practice', 'people with dementia (PWD']","['Advance care planning (ACP', 'educational intervention', 'ACP, including shared decision-making and role-playing exercises']","['number of medical (ie, resuscitation, hospital admission) and nonmedical (ie, activities, social contacts) preferences discussed', 'ACP initiation: the proportion of PWD that had at least 1 ACP conversation documented in their medical file', 'ACP initiation']","[{'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}]","[{'cui': 'C0600371', 'cui_str': 'Advance Health Care Planning'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0035822', 'cui_str': 'Role Playings'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0237101', 'cui_str': 'Social interaction finding'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0180853', 'cui_str': 'File, device (physical object)'}]",38.0,0.0955912,"Intervention group GPs discussed 0.8 more medical [95% confidence interval (CI) 0.3, 1.3; P = .003] and 1.5 more nonmedical (95% CI 0.8, 2.3; P < .001) preferences per person with dementia than control group GPs.
","[{'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Tilburgs', 'Affiliation': 'Department of IQ Healthcare, Radboud University Medical Centre Nijmegen, the Netherlands. Electronic address: Bram.Tilburgs@radboudumc.nl.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Koopmans', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Centre, Nijmegen, the Netherlands; Radboudumc Alzheimer Centre, Nijmegen, the Netherlands; Joachim en Anna, Centre for Specialized Geriatric Care, Nijmegen, the Netherlands.'}, {'ForeName': 'Myrra', 'Initials': 'M', 'LastName': 'Vernooij-Dassen', 'Affiliation': 'Department of IQ Healthcare, Radboud University Medical Centre Nijmegen, the Netherlands.'}, {'ForeName': 'Eddy', 'Initials': 'E', 'LastName': 'Adang', 'Affiliation': 'Department for Health Evidence, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'Schers', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Teerenstra', 'Affiliation': 'Department for Health Evidence, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'van de Pol', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Carolien', 'Initials': 'C', 'LastName': 'Smits', 'Affiliation': 'Research Group Innovating with Older Adults, Windesheim University of Applied Sciences, Zwolle, the Netherlands.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Engels', 'Affiliation': 'Department of Anaesthesiology, Pain and Palliative Medicine, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Perry', 'Affiliation': 'Radboudumc Alzheimer Centre, Nijmegen, the Netherlands; Department of Geriatric Medicine, Radboud University Medical Centre, Nijmegen, the Netherlands.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.09.010']
1222,31763933,Pathways to Recovery among Homeless People with Mental Illness: Is Impulsiveness Getting in the Way?,"OBJECTIVE


This study investigates the association between impulsiveness and six dimensions of recovery among homeless people with mental illness.
METHOD


The sample was composed of 418 participants of a randomized controlled trial of Housing First, a recovery-oriented program that provides immediate access to permanent housing. The reliable change index method was used to provide an estimate of the statistical and clinical significance of the change from baseline to 24 months (i.e., clinically meaningful improvement), on outcomes that pertain to recovery dimensions: psychiatric symptoms (clinical), physical health and substance use problems (physical), residential stability (functional), arrests (criminological), community integration (social), and hope and personal confidence (existential). We tested for the effect of impulsiveness, assessed with the Barratt Impulsiveness Scale-11, on clinically meaningful improvement on each specific outcome, adjusting for age, gender and intervention assignment, as both intervention arms were included in the analysis.
RESULTS


For every increase in total impulsiveness score by one standard deviation, the odds of experiencing clinically meaningful improvement decreased by 29% ( OR  = 0.71, 95% CI, 0.55 to 0.91) on the clinical dimension and by 53% ( OR  = 0.47, 95% CI, 0.32 to 0.68) on the existential dimension. However, changes in outcomes pertaining to physical, functional, criminological, and social dimensions were not significantly influenced by impulsiveness.
CONCLUSIONS


Findings highlight the importance of addressing impulsiveness in the context of recovery-oriented interventions for homeless people with mental illness. Further research may be required to improve interventions that are responsive to unique needs of impulsive individuals to support clinical and existential recovery.",2020,"However, changes in outcomes pertaining to physical, functional, criminological, and social dimensions were not significantly influenced by impulsiveness.
","['418 participants', 'homeless people with mental illness', 'Homeless People with Mental Illness']",[],"['recovery dimensions: psychiatric symptoms (clinical), physical health and substance use problems (physical), residential stability (functional), arrests (criminological), community integration (social), and hope and personal confidence (existential', 'physical, functional, criminological, and social dimensions', 'total impulsiveness score']","[{'cui': 'C0237154', 'cui_str': 'Homelessness'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}]",[],"[{'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom (finding)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0237477', 'cui_str': 'Arrested (qualifier value)'}, {'cui': 'C3494302', 'cui_str': 'Community Integration'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",418.0,0.0674948,"However, changes in outcomes pertaining to physical, functional, criminological, and social dimensions were not significantly influenced by impulsiveness.
","[{'ForeName': 'Marichelle C', 'Initials': 'MC', 'LastName': 'Leclair', 'Affiliation': 'Department of Psychology, Université de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Ashley J', 'Initials': 'AJ', 'LastName': 'Lemieux', 'Affiliation': 'Institut national de psychiatrie légale Philippe-Pinel, Montréal, Québec, Canada.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Roy', 'Affiliation': 'Institut national de psychiatrie légale Philippe-Pinel, Montréal, Québec, Canada.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Martin', 'Affiliation': 'School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Latimer', 'Affiliation': 'Douglas Mental Health University Institute, Montréal, Québec, Canada.'}, {'ForeName': 'Anne G', 'Initials': 'AG', 'LastName': 'Crocker', 'Affiliation': 'Institut national de psychiatrie légale Philippe-Pinel, Montréal, Québec, Canada.'}]",Canadian journal of psychiatry. Revue canadienne de psychiatrie,['10.1177/0706743719885477']
1223,31763936,The impact of flushing with pre-filled saline syringes on the incidence of peripheral venous catheter failure: A quasi-experimental study.,"BACKGROUND


Short peripheral venous catheters are one of the most frequently used devices in hospitals. Peripheral venous catheter failure, defined as the unscheduled dysfunction of peripheral venous catheter, is common and frequently entails a new invasive procedure. Flushing the catheter maintains patency and could prolong peripheral venous catheter dwell time. The introduction of pre-filled saline flushing syringes as compared to manually filled saline flushing syringes could facilitate the frequency of catheter flushing, and subsequently it could reduce peripheral venous catheter failure rate.
OBJECTIVE


To demonstrate differences in overall peripheral venous catheter failure rates before and after the introduction of pre-filled saline flushing syringes and to assess the risk factors for peripheral venous catheter failure.
METHODS


Quasi-experimental design, before-and-after intervention study. Intervention: introduction of pre-filled saline syringes for flushing. Multicenter study conducted in medical and surgical wards of three European hospitals during a 9-month period (4 months pre-intervention, 5 months intervention). A multivariate Cox proportional model was used to identify factors associated with the occurrence of peripheral venous catheter failure.
RESULTS


Data from 3853 peripheral venous catheters in 1915 patients were analyzed. Compared to pre-intervention period, a significant decrease in peripheral venous catheter failure rate was observed in the intervention period (57% vs 43.4%, p < 0.001). Independent factors associated with peripheral venous catheter failure were as follows: Charlson score ⩾4 (hazard ratio: 1.648; 95% confidence interval: 1.069-2.527), days of hospital stay ⩾10 (hazard ratio: 1.468; 95% confidence interval: 1.172-1.837), and catheter ""D"" (hazard ratio: 1.758; 95% confidence interval: 1.058-2.919).
CONCLUSION


The use of pre-filled saline syringes significantly reduced peripheral venous catheter failure and increased catheter dwell time. Thus, it is important to reinforce the use of the pre-filled syringes for flushing to reduce the incidence of peripheral venous catheters' failure.",2019,"Compared to pre-intervention period, a significant decrease in peripheral venous catheter failure rate was observed in the intervention period (57% vs 43.4%, p < 0.001).","['Multicenter study conducted in medical and surgical wards of three European hospitals during a 9-month period (4\u2009months pre-intervention, 5\u2009months intervention', '3853 peripheral venous catheters in 1915 patients were analyzed']","['pre-filled saline syringes', 'flushing with pre-filled saline syringes']","['peripheral venous catheter failure', 'overall peripheral venous catheter failure rates', 'peripheral venous catheter failure rate', 'hospital stay ⩾10', 'peripheral venous catheter dwell time', 'peripheral venous catheter failure and increased catheter dwell time']","[{'cui': 'C1096776', 'cui_str': 'Multicenter Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0745442', 'cui_str': 'Venous catheter (physical object)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0039142', 'cui_str': 'Syringes'}, {'cui': 'C0016382', 'cui_str': 'Flushing'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0745442', 'cui_str': 'Venous catheter (physical object)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0429659', 'cui_str': 'Dwell time (observable entity)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}]",1915.0,0.0342401,"Compared to pre-intervention period, a significant decrease in peripheral venous catheter failure rate was observed in the intervention period (57% vs 43.4%, p < 0.001).","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Saliba', 'Affiliation': 'Department of Infectious Diseases, Bellvitge University Hospital, Biomedical Research Institute of Bellvitge (IDIBELL), Barcelona, Spain.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Cuervo', 'Affiliation': 'Department of Infectious Diseases, Bellvitge University Hospital, Biomedical Research Institute of Bellvitge (IDIBELL), Barcelona, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Hornero', 'Affiliation': 'Department of Infectious Diseases, Bellvitge University Hospital, Biomedical Research Institute of Bellvitge (IDIBELL), Barcelona, Spain.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'De Carli', 'Affiliation': 'UOC Emerging Infections-CRAIDS, National Institute for Infectious Diseases Lazzaro Spallanzani-IRCCS, Rome, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Marani', 'Affiliation': 'UOC Emerging Infections-CRAIDS, National Institute for Infectious Diseases Lazzaro Spallanzani-IRCCS, Rome, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Puro', 'Affiliation': 'UOC Emerging Infections-CRAIDS, National Institute for Infectious Diseases Lazzaro Spallanzani-IRCCS, Rome, Italy.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Felisa López', 'Affiliation': 'Department of Infectious Diseases, Sant Joan de Reus University Hospital, Reus, Spain.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Iftimie', 'Affiliation': 'Department of Infectious Diseases, Sant Joan de Reus University Hospital, Reus, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Castro', 'Affiliation': 'Department of Infectious Diseases, Sant Joan de Reus University Hospital, Reus, Spain.'}, {'ForeName': 'Vicens', 'Initials': 'V', 'LastName': 'Diaz-Brito Fernandez', 'Affiliation': 'Department of Infectious Diseases, Sant Joan de Déu, Health Institute Sant Boi, Spain.'}, {'ForeName': 'Maria Carmen', 'Initials': 'MC', 'LastName': 'Alvarez Moya', 'Affiliation': 'Department of Infectious Diseases, Sant Joan de Déu, Health Institute Sant Boi, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Jimenez De La Rosa', 'Affiliation': 'Department of Infectious Diseases, Sant Joan de Déu, Health Institute Sant Boi, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Martínez-Sánchez', 'Affiliation': 'Department of Basic Sciences, International University of Catalonia, Barcelona, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Jimenez', 'Affiliation': 'Department of Infectious Diseases, Bellvitge University Hospital, Biomedical Research Institute of Bellvitge (IDIBELL), Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Carratalà', 'Affiliation': 'Department of Infectious Diseases, Bellvitge University Hospital, Biomedical Research Institute of Bellvitge (IDIBELL), Barcelona, Spain.'}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Pujol', 'Affiliation': 'Department of Infectious Diseases, Bellvitge University Hospital, Biomedical Research Institute of Bellvitge (IDIBELL), Barcelona, Spain.'}]",The journal of vascular access,['10.1177/1129729819888423']
1224,32492126,Effect of Gastric Bypass vs Best Medical Treatment on Early-Stage Chronic Kidney Disease in Patients With Type 2 Diabetes and Obesity: A Randomized Clinical Trial.,"Importance


Early-stage chronic kidney disease (CKD) characterized by microalbuminuria is associated with future cardiovascular events, progression toward end-stage renal disease, and early mortality in patients with type 2 diabetes.
Objective


To compare the albuminuria-lowering effects of Roux-en-Y gastric bypass (RYGB) surgery vs best medical treatment in patients with early-stage CKD, type 2 diabetes, and obesity.
Design, Setting, and Participants


For this randomized clinical trial, patients with established type 2 diabetes and microalbuminuria were recruited from a single center from April 1, 2013, through March 31, 2016, with a 5-year follow-up, including prespecified intermediate analysis at 24-month follow-up.
Intervention


A total of 100 patients with type 2 diabetes, obesity (body mass indexes of 30 to 35 [calculated as weight in kilograms divided by height in meters squared]), and stage G1 to G3 and A2 to A3 CKD (urinary albumin-creatinine ratio [uACR] >30 mg/g and estimated glomerular filtration rate >30 mL/min) were randomized 1:1 to receive best medical treatment (n = 49) or RYGB (n = 51).
Main Outcomes and Measures


The primary outcome was remission of albuminuria (uACR <30 mg/g). Secondary outcomes were CKD remission rate, absolute change in uACR, metabolic control, other microvascular complications, quality of life, and safety.
Results


A total of 100 patients (mean [SD] age, 51.4 [7.6] years; 55 [55%] male) were randomized: 51 to RYGB and 49 to best medical care. Remission of albuminuria occurred in 55% of patients (95% CI, 39%-70%) after best medical treatment and 82% of patients (95% CI, 72%-93%) after RYGB (P = .006), resulting in CKD remission rates of 48% (95% CI, 32%-64%) after best medical treatment and 82% (95% CI, 72%-92%) after RYGB (P = .002). The geometric mean uACRs were 55% lower after RYGB (10.7 mg/g of creatinine) than after best medical treatment (23.6 mg/g of creatinine) (P < .001). No difference in the rate of serious adverse events was observed.
Conclusions and Relevance


After 24 months, RYGB was more effective than best medical treatment for achieving remission of albuminuria and stage G1 to G3 and A2 to A3 CKD in patients with type 2 diabetes and obesity.
Trial Registration


ClinicalTrials.gov Identifier: NCT01821508.",2020,"After 24 months, RYGB was more effective than best medical treatment for achieving remission of albuminuria and stage G1 to G3 and A2 to A3 CKD in patients with type 2 diabetes and obesity.
","['Patients With Type 2 Diabetes and Obesity', '100 patients with type 2 diabetes, obesity (body mass indexes of 30 to 35 [calculated as weight in kilograms divided by height in meters squared]), and stage G1 to G3 and A2 to A3 CKD (urinary albumin-creatinine ratio [uACR] >30 mg/g and estimated glomerular filtration rate >30 mL/min', '100 patients (mean [SD] age, 51.4 [7.6] years; 55 [55%] male) were randomized: 51 to RYGB and 49 to best medical care', 'patients with established type 2 diabetes and microalbuminuria were recruited from a single center from April 1, 2013, through March 31, 2016, with a 5-year follow-up, including prespecified intermediate analysis at 24-month follow-up', 'patients with type 2 diabetes', 'patients with early-stage CKD, type 2 diabetes, and obesity']","['RYGB', 'Gastric Bypass vs Best Medical Treatment', 'Roux-en-Y gastric bypass (RYGB) surgery']","['remission of albuminuria (uACR', 'Remission of albuminuria', 'geometric mean uACRs', 'CKD remission rate, absolute change in uACR, metabolic control, other microvascular complications, quality of life, and safety', 'rate of serious adverse events', 'CKD remission rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0486293', 'cui_str': 'Albumin/creatinine ratio measurement'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0730345', 'cui_str': 'Microalbuminuria'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}]","[{'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",100.0,0.0885028,"After 24 months, RYGB was more effective than best medical treatment for achieving remission of albuminuria and stage G1 to G3 and A2 to A3 CKD in patients with type 2 diabetes and obesity.
","[{'ForeName': 'Ricardo Vitor', 'Initials': 'RV', 'LastName': 'Cohen', 'Affiliation': 'The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.'}, {'ForeName': 'Tiago Veiga', 'Initials': 'TV', 'LastName': 'Pereira', 'Affiliation': ""Applied Health Research Center, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Cristina Mamédio', 'Initials': 'CM', 'LastName': 'Aboud', 'Affiliation': 'The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.'}, {'ForeName': 'Tarissa Beatrice Zanata', 'Initials': 'TBZ', 'LastName': 'Petry', 'Affiliation': 'The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Lopes Correa', 'Affiliation': 'The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.'}, {'ForeName': 'Carlos Aurélio', 'Initials': 'CA', 'LastName': 'Schiavon', 'Affiliation': 'Research Institute, Hospital do Coração, São Paulo, Brazil.'}, {'ForeName': 'Carlos Eduardo', 'Initials': 'CE', 'LastName': 'Pompílio', 'Affiliation': 'The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.'}, {'ForeName': 'Fernando Nogueira Quirino', 'Initials': 'FNQ', 'LastName': 'Pechy', 'Affiliation': 'The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.'}, {'ForeName': 'Ana Carolina Calmon', 'Initials': 'ACC', 'LastName': 'da Costa Silva', 'Affiliation': 'The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.'}, {'ForeName': 'Fernanda Lendimuth Gomes', 'Initials': 'FLG', 'LastName': 'de Melo', 'Affiliation': 'The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.'}, {'ForeName': 'Lívia Porto', 'Initials': 'LP', 'LastName': 'Cunha da Silveira', 'Affiliation': 'The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.'}, {'ForeName': 'Pedro Paulo', 'Initials': 'PP', 'LastName': 'de Paris Caravatto', 'Affiliation': 'The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.'}, {'ForeName': 'Helio', 'Initials': 'H', 'LastName': 'Halpern', 'Affiliation': 'The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.'}, {'ForeName': 'Frederico de Lima Jacy', 'Initials': 'FLJ', 'LastName': 'Monteiro', 'Affiliation': 'The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'da Costa Martins', 'Affiliation': 'The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.'}, {'ForeName': 'Rogerio', 'Initials': 'R', 'LastName': 'Kuga', 'Affiliation': 'The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.'}, {'ForeName': 'Thais Mantovani Sarian', 'Initials': 'TMS', 'LastName': 'Palumbo', 'Affiliation': 'The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.'}, {'ForeName': 'Neil Gerard', 'Initials': 'NG', 'LastName': 'Docherty', 'Affiliation': 'Diabetes Complications Research Center, UCD Conway Institute, University College Dublin School of Medicine, Dublin, Ireland.'}, {'ForeName': 'Carel Wynand', 'Initials': 'CW', 'LastName': 'le Roux', 'Affiliation': 'Diabetes Complications Research Center, UCD Conway Institute, University College Dublin School of Medicine, Dublin, Ireland.'}]",JAMA surgery,['10.1001/jamasurg.2020.0420']
1225,31157710,PERIPHERAL ISCHEMIC RETINAL PHOTOCOAGULATION IN ADDITION TO INTRAVITREAL BEVACIZUMAB VERSUS INTRAVITREAL BEVACIZUMAB ALONE FOR THE TREATMENT OF MACULAR EDEMA SECONDARY TO CENTRAL RETINAL VEIN OCCLUSION: A Randomized Double-Masked Controlled Clinical Trial.,"PURPOSE


To investigate the effects of peripheral ischemic retinal photocoagulation in addition to intravitreal bevacizumab (IVB) in the treatment of macular edema due to ischemic central retinal vein occlusion.
METHODS


Forty-eight eyes of 48 treatment-naive patients were randomly selected and divided into 2 groups. Group A comprised 24 eyes that were treated with three consecutive monthly injections of IVB, and Group B comprised 24 eyes that were treated with IVB plus photocoagulation of the peripheral nonperfused retina. Further IVB injections were administered as needed in both groups. Monthly follow-up was conducted for 9 months after the first injection.
RESULTS


The data of 46 patients were analyzed. Best-corrected visual acuity changes from the fourth to eighth month follow-up in comparison with the baseline were significantly higher in Group B (P = 0.002-0.044-0.002-0.002-0.012). In addition, significant differences were observed in central macular thickness in Group B throughout the study period (all P < 0.001). Group B required less frequent IVB injections during the 9-month study period.
CONCLUSION


Photocoagulation of the retinal nonperfused area in patients with macular edema because of central retinal vein occlusion might amplify the beneficial effects of IVB on best-corrected visual acuity and central macular thickness and reduce the frequency of IVB injection.",2020,Best-corrected visual acuity changes from the fourth to eighth month follow-up in comparison with the baseline were significantly higher in Group B (P = 0.002-0.044-0.002-0.002-0.012).,"['patients with macular edema', 'macular edema due to ischemic central retinal vein occlusion', '46 patients were analyzed', 'Forty-eight eyes of 48 treatment-naive patients']","['intravitreal bevacizumab (IVB', 'peripheral ischemic retinal photocoagulation', 'Photocoagulation', 'IVB plus photocoagulation of the peripheral nonperfused retina', 'IVB']","['central macular thickness', 'Best-corrected visual acuity changes', 'frequent IVB injections', 'frequency of IVB injection']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0271051', 'cui_str': 'Macular Edema'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0154841', 'cui_str': 'Central retinal vein occlusion (disorder)'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0023694', 'cui_str': 'Photocoagulation'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0035298', 'cui_str': 'Retina'}]","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",46.0,0.0875688,Best-corrected visual acuity changes from the fourth to eighth month follow-up in comparison with the baseline were significantly higher in Group B (P = 0.002-0.044-0.002-0.002-0.012).,"[{'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Nourinia', 'Affiliation': 'Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Emamverdi', 'Affiliation': 'Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Ramezani', 'Affiliation': 'Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Yashar', 'Initials': 'Y', 'LastName': 'Amizadeh', 'Affiliation': 'Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Khorshidifar', 'Affiliation': 'Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Behnaz', 'Affiliation': 'Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sare', 'Initials': 'S', 'LastName': 'Safi', 'Affiliation': 'Ophthalmic Epidemiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002573']
1226,31174454,The effect of process and outcome feedback in highly distressed outpatients: A randomized controlled trial.,"Objectives:  Although process and outcome feedback is considered to be facilitative of psychotherapeutic processes, recent studies have suggested that such feedback may not produce the same effect when applied to highly distressed patients. This study examined the effect of process and outcome feedback in highly distressed patients treated in a public mental health center in Israel. Method:  Patients ( n  = 197) were randomly allocated to receive feedback, or to treatment as usual. Therapists in the feedback condition received weekly reports, whereas therapists in the control group received no feedback. After attrition from study and treatment, a total of 123 cases were analyzed. Results:  Feedback had no significant effect on either symptom reduction or on well-being. However, patients in the feedback group showed higher gains in alliance as compared to the treatment as usual group. Conclusion:  Process and outcome feedback might have a potential beneficial effect of improving alliance for patients with severe symptomatology, with whom the establishment of an alliance can be challenging. The current findings also stress the need to continue to study the effect of feedback on therapy outcomes in diverse clinical settings. Limitations and directions for future research are discussed.",2020,Feedback had no significant effect on either symptom reduction or on well-being.,"['highly distressed patients', 'patients with severe symptomatology', 'Method:  Patients ( n \u2009=\u2009197', 'highly distressed outpatients', 'highly distressed patients treated in a public mental health center in Israel']",[],"['higher gains in alliance', 'symptom reduction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022271', 'cui_str': 'Israel'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",123.0,0.0274935,Feedback had no significant effect on either symptom reduction or on well-being.,"[{'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Tzur Bitan', 'Affiliation': 'Department of Behavioral Sciences, Ariel University, Ariel, Israel.'}, {'ForeName': 'Yogev', 'Initials': 'Y', 'LastName': 'Kivity', 'Affiliation': 'Department of Psychology, Pennsylvania State University, University Park, Pennsylvania, USA.'}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Ganor', 'Affiliation': 'Shalvata Mental Health Center, Hod Hasharon, affiliated with the Sackler School of Medicine, Tel Aviv University, Ramat Aviv, Israel.'}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Biran', 'Affiliation': 'Shalvata Mental Health Center, Hod Hasharon, affiliated with the Sackler School of Medicine, Tel Aviv University, Ramat Aviv, Israel.'}, {'ForeName': 'Ariella', 'Initials': 'A', 'LastName': 'Grossman-Giron', 'Affiliation': 'Department of Behavioral Sciences, Ariel University, Ariel, Israel.'}, {'ForeName': 'Yuval', 'Initials': 'Y', 'LastName': 'Bloch', 'Affiliation': 'Shalvata Mental Health Center, Hod Hasharon, affiliated with the Sackler School of Medicine, Tel Aviv University, Ramat Aviv, Israel.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2019.1627014']
1227,31143442,Protocol for a comparison study of 1-day (single dose) versus 2-day prophylactic antibiotic administration in Holmium Laser enucleation of the prostate (HoLEP): a randomized controlled trial.,"Background:  The best method of antimicrobial prophylaxis administration for surgical site infection (SSI) in transurethral holmium laser resection and enucleation of the prostate (HoLEP)/bipolar transurethral enucleation (TUEB) remains controversial. The purpose of this study is to compare one-day and two-day cefazolin in a randomized 2  nd -phase study to help establish a protocol with a 95% confidence interval (CI) for SSI prevention.  Methods:  Patients undergoing HoLEP/TUEB for benign prostate hyperplasia without preoperative pyuria will be enrolled and randomized to receive prophylactic antibiotic administration for HoLEP/TUEB in two groups, 1-day (single dose) cefazolin and 2-day cefazolin. The primary endpoint is the occurrence rate of postoperative urinary tract infection or urogenital infection within 30 days after HoLEP/TUEB with a statistical 95% CI in comparison between those groups. Secondary outcomes include the kind of infectious disease and evidence of diagnosis, day of diagnosis of infectious disease, performance of urine or blood culture, detection of bacteria, treatments, duration of treatments, AEs other than surgical site infection, and drug-induced AEs.  Discussion:  The results of this study will provide evidence for defining the optimal duration of cefazolin prophylactic antibiotic administration for SSI.  Trial registration:  This study was registered in the University Hospital Medical Information Network-Clinical Trial Registry ( UMIN000027955) based on recommendations from the International Committee of Medical Journal Editors (ICMJE) on July 1  st  2017.",2019,The best method of antimicrobial prophylaxis administration for surgical site infection (SSI) in transurethral holmium laser resection and enucleation of the prostate (HoLEP)/bipolar transurethral enucleation (TUEB) remains controversial.,"['Holmium Laser enucleation of the prostate (HoLEP', 'for benign prostate hyperplasia without preoperative pyuria']","['HoLEP/TUEB', 'cefazolin and 2-day cefazolin', 'cefazolin', '2-day prophylactic antibiotic administration', 'prophylactic antibiotic administration for HoLEP/TUEB', 'transurethral holmium laser resection and enucleation of the prostate (HoLEP)/bipolar transurethral enucleation (TUEB']","['kind of infectious disease and evidence of diagnosis, day of diagnosis of infectious disease, performance of urine or blood culture, detection of bacteria, treatments, duration of treatments, AEs other than surgical site infection, and drug-induced AEs', 'occurrence rate of postoperative urinary tract infection or urogenital infection']","[{'cui': 'C1955839', 'cui_str': 'Holmium Lasers'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0034359', 'cui_str': 'Pyuria'}]","[{'cui': 'C0007546', 'cui_str': 'Cefazolin'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}, {'cui': 'C1955839', 'cui_str': 'Holmium Lasers'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}]","[{'cui': 'C1273849', 'cui_str': 'Infectious Diseases Specialty'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C0200949', 'cui_str': 'Blood Culture Test'}, {'cui': 'C1261143', 'cui_str': 'Detection of bacteria'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment (qualifier value)'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0458082', 'cui_str': 'Drug-induced (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0403709', 'cui_str': 'Postoperative urinary tract infection (disorder)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",2.0,0.224909,The best method of antimicrobial prophylaxis administration for surgical site infection (SSI) in transurethral holmium laser resection and enucleation of the prostate (HoLEP)/bipolar transurethral enucleation (TUEB) remains controversial.,"[{'ForeName': 'Katsumi', 'Initials': 'K', 'LastName': 'Shigemura', 'Affiliation': 'Department of Urology, Kobe University, Kobe, Hyogo, 650-0017, Japan.'}, {'ForeName': 'Fukashi', 'Initials': 'F', 'LastName': 'Yamamichi', 'Affiliation': 'Department of Urology, Hara Genitourinary Hospital, Kobe, Japan.'}, {'ForeName': 'Kento', 'Initials': 'K', 'LastName': 'Nishimoto', 'Affiliation': 'Department of Public Health, Kobe University Graduate School of Health Science, Kobe, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Kitagawa', 'Affiliation': 'Division of Advanced Medical Science, Kobe University Graduate School of Science, Technology and Innovation, Kobe, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Fujisawa', 'Affiliation': 'Department of Urology, Kobe University, Kobe, Hyogo, 650-0017, Japan.'}]",F1000Research,['10.12688/f1000research.17660.2']
1228,31167902,Effect of menthol cigarette and other menthol tobacco product bans on tobacco purchases in the RTI iShoppe virtual convenience store.,"OBJECTIVE


To test how a potential US ban of menthol products or replacement with 'green' products and ads could influence tobacco purchases.
METHODS


US adult menthol smokers (N=1197) were recruited via an online panel and randomly assigned to complete a shopping task in one of four versions (experimental conditions) of the RTI iShoppe virtual store: (1) no ban, (2) replacement of menthol cigarettes and ads with green replacement versions, (3) menthol cigarette ban and (4) all menthol tobacco product ban. Logistic regressions assessed the effect of condition on tobacco purchases.
RESULTS


Participants in the menthol cigarette ban (OR=0.67, 95% CI 0.48 to 0.92) and all menthol product ban conditions (OR=0.60, 95% CI 0.43 to 0.83) were less likely to purchase cigarettes of any type than participants in the no ban condition. Participants in the green replacement (OR=1.74, 95% CI 1.13 to 2.70), menthol cigarette ban (OR=3.40, 95% CI 2.14 to 5.41) and all menthol product ban conditions (OR=3.14, 95% CI 1.97 to 5.01) were more likely to purchase a cigarette brand different from their usual brand than participants in the no ban condition.
CONCLUSIONS


Our findings suggest that menthol bans could have great public health impact by reducing cigarette purchases. However, tobacco marketing strategies, such as creating green (or other replacement) versions of menthol cigarettes, may undermine public health benefits of a menthol ban by prompting purchases of non-menthol cigarettes. Our findings highlight the importance of taking tobacco marketing tactics into consideration in tobacco product regulation.",2020,"Participants in the green replacement (OR=1.74, 95% CI 1.13 to 2.70), menthol cigarette ban (OR=3.40, 95% CI 2.14 to 5.41) and all menthol product ban conditions (OR=3.14, 95% CI 1.97 to 5.01) were more likely to purchase a cigarette brand different from their usual brand than participants in the no ban condition.
","['US adult menthol smokers (N=1197', 'tobacco purchases in the RTI iShoppe virtual convenience store']","['shopping task in one of four versions (experimental conditions) of the RTI iShoppe virtual store: (1) no ban, (2) replacement of menthol cigarettes and ads with green replacement versions, (3) menthol cigarette ban and (4) all menthol tobacco product ban', 'menthol cigarette and other menthol tobacco product']",['menthol cigarette'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}]","[{'cui': 'C0150768', 'cui_str': 'Shopping (observable entity)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0105185', 'cui_str': 'BANS'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332583', 'cui_str': 'Green color (qualifier value)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}]","[{'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]",1197.0,0.0670835,"Participants in the green replacement (OR=1.74, 95% CI 1.13 to 2.70), menthol cigarette ban (OR=3.40, 95% CI 2.14 to 5.41) and all menthol product ban conditions (OR=3.14, 95% CI 1.97 to 5.01) were more likely to purchase a cigarette brand different from their usual brand than participants in the no ban condition.
","[{'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Guillory', 'Affiliation': 'Prime Affect Research, Dublin, Ireland jamieguillory.contractor@rti.org.'}, {'ForeName': 'Annice E', 'Initials': 'AE', 'LastName': 'Kim', 'Affiliation': 'Center for Health Policy Science and Tobacco Research, RTI International, Research Triangle Park, North Carolina, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Nonnemaker', 'Affiliation': 'Center for Health Policy Science and Tobacco Research, RTI International, Research Triangle Park, North Carolina, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Bradfield', 'Affiliation': 'Center for Health Policy Science and Tobacco Research, RTI International, Research Triangle Park, North Carolina, USA.'}, {'ForeName': 'Nathaniel Harlan', 'Initials': 'NH', 'LastName': 'Taylor', 'Affiliation': 'Center for Health Policy Science and Tobacco Research, RTI International, Research Triangle Park, North Carolina, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Dutra', 'Affiliation': 'Center for Health Policy Science and Tobacco Research, RTI International, Research Triangle Park, North Carolina, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Feld', 'Affiliation': 'Center for Health Policy Science and Tobacco Research, RTI International, Research Triangle Park, North Carolina, USA.'}]",Tobacco control,['10.1136/tobaccocontrol-2019-054997']
1229,31868201,"A modified low-protein infant formula supports adequate growth in healthy, term infants: a randomized, double-blind, equivalence trial.","BACKGROUND


A high protein intake in early life is associated with a risk of obesity later in life. The essential amino acid requirements of formula-fed infants have been reassessed recently, enabling a reduction in total protein content and thus in protein intake.
OBJECTIVES


We aimed to assess the safety of an infant formula with a modified amino acid profile and a modified low-protein (mLP) content in healthy term-born infants. Outcomes were compared with a specifically designed control (CTRL) infant formula.
METHODS


In this double-blind, randomized controlled equivalence trial, infants received either mLP (1.7 g protein/100 kcal; n = 90) or CTRL formula (2.1 g protein/100 kcal; n = 88) from enrollment (age ≤ 45 d) to 6 mo of age. A breastfed group served as a reference (n = 67). Anthropometry and body composition were determined at baseline, 17 wk (including safety blood parameters), and 6 mo of age. The primary outcome was daily weight gain from enrollment up until the age of 17 wk (at an equivalence margin of ±3.0 g/d).
RESULTS


Weight gain from baseline (mean ± SD age: 31 ± 9 d) up to the age of 17 wk was equivalent between the mLP and CTRL formula groups (27.9 and 28.8 g/d, respectively; difference: -0.86 g/d; 90% CI: -2.36, 0.63 g/d). No differences in other growth parameters, body composition, or in adverse events were observed. Urea was significantly lower in the mLP formula group than in the CTRL formula group (-0.74 mmol/L; 95% CI: -0.97, -0.51 mmol/L; P < 0.001). Growth rates, fat mass, fat-free mass, and several essential amino acids were significantly higher in both formula groups than in the breastfed reference group.
CONCLUSIONS


Feeding an infant formula with a modified amino acid profile and a lower protein content from an average age of 1 mo until the age of 6 mo is safe and supports an adequate growth, similar to that of infants consuming CTRL formula. This trial was registered at www.trialregister.nl as Trial NL4677.",2020,"Growth rates, fat mass, fat-free mass, and several essential amino acids were significantly higher in both formula groups than in the breastfed reference group.
","['healthy, term infants', 'SD age: 31\xa0±\xa09 d) up to the age of 17 wk', 'healthy term-born infants']","['mLP', 'modified low-protein infant formula', 'infant formula with a modified amino acid profile and a modified low-protein (mLP']","['Anthropometry and body composition', 'daily weight gain', 'Weight gain', 'Growth rates, fat mass, fat-free mass, and several essential amino acids', 'Urea', 'growth parameters, body composition, or in adverse events']","[{'cui': 'C0456128', 'cui_str': 'Term infant (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0150589', 'cui_str': 'Baby Formula'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}]","[{'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0449249', 'cui_str': 'Growth rate (attribute)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0002525', 'cui_str': 'Amino Acids, Essential'}, {'cui': 'C0070525', 'cui_str': 'phenacemide'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.46606,"Growth rates, fat mass, fat-free mass, and several essential amino acids were significantly higher in both formula groups than in the breastfed reference group.
","[{'ForeName': 'Stefanie M P', 'Initials': 'SMP', 'LastName': 'Kouwenhoven', 'Affiliation': ""Emma Children's Hospital, Amsterdam UMC, Vije Universiteit Amsterdam, University of Amsterdam, Amsterdam, Netherlands.""}, {'ForeName': 'Nadja', 'Initials': 'N', 'LastName': 'Antl', 'Affiliation': ""Division of Metabolic and Nutritional Medicine, LMU - Ludwig-Maximilians-Universität Munich, University of Munich Medical Centre, Dr. von Hauner Children's Hospital, Munich, Germany.""}, {'ForeName': 'Martijn J J', 'Initials': 'MJJ', 'LastName': 'Finken', 'Affiliation': ""Department of Pediatric Endocrinology, Emma Children's Hospital, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.""}, {'ForeName': 'Jos W R', 'Initials': 'JWR', 'LastName': 'Twisk', 'Affiliation': 'Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Eline M', 'Initials': 'EM', 'LastName': 'van der Beek', 'Affiliation': 'Danone Nutricia Research, Utrecht, Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Abrahamse-Berkeveld', 'Affiliation': 'Danone Nutricia Research, Utrecht, Netherlands.'}, {'ForeName': 'Bert J M', 'Initials': 'BJM', 'LastName': 'van de Heijning', 'Affiliation': 'Danone Nutricia Research, Utrecht, Netherlands.'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'Schierbeek', 'Affiliation': 'Stable Isotope Laboratory, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Lesca M', 'Initials': 'LM', 'LastName': 'Holdt', 'Affiliation': 'Institute of Laboratory Medicine, LMU - Ludwig-Maximilians-Universität Munich, University of Munich Medical Centre, Munich, Germany.'}, {'ForeName': 'Johannes B', 'Initials': 'JB', 'LastName': 'van Goudoever', 'Affiliation': ""Emma Children's Hospital, Amsterdam UMC, Vije Universiteit Amsterdam, University of Amsterdam, Amsterdam, Netherlands.""}, {'ForeName': 'Berthold V', 'Initials': 'BV', 'LastName': 'Koletzko', 'Affiliation': ""Division of Metabolic and Nutritional Medicine, LMU - Ludwig-Maximilians-Universität Munich, University of Munich Medical Centre, Dr. von Hauner Children's Hospital, Munich, Germany.""}]",The American journal of clinical nutrition,['10.1093/ajcn/nqz308']
1230,31152658,The Degree of Aminoacidemia after Dairy Protein Ingestion Does Not Modulate the Postexercise Anabolic Response in Young Men: A Randomized Controlled Trial.,"BACKGROUND


Resistance exercise and dietary protein stimulate muscle protein synthesis (MPS). The rate at which proteins are digested and absorbed into circulation alters peak plasma amino acid concentrations and may modulate postexercise MPS. A novel mineral modified milk protein concentrate (mMPC), with identical amino acid composition to standard milk protein concentrate (MPC), was formulated to induce rapid aminoacidemia.
OBJECTIVES


The aim of this study was to determine whether rapid aminoacidemia and greater peak essential amino acid (EAA) concentrations induced by mMPC would stimulate greater postresistance exercise MPS, anabolic signaling, and ribosome biogenesis compared to standard dairy proteins, which induce a small but sustained plasma essential aminoacidemia.
METHODS


Thirty healthy young men (22.5 ± 3.0 y; BMI 23.8 ± 2.7 kg/m2) received primed constant infusions of l-[ring-13C6]-phenylalanine and completed 3 sets of leg presses and leg extensions at 80% of 1 repetition. Afterwards, participants were randomly assigned in a double-blind fashion to consume 25 g mMPC, MPC, or calcium caseinate (CAS). Vastus lateralis biopsies were collected at rest, and 2 and 4 h post exercise.
RESULTS


Plasma EAA concentrations, including leucine, were 19.2-26.6% greater in the mMPC group 45-90 min post ingestion than in MPC and CAS groups (P < 0.001). Myofibrillar fractional synthetic rate from baseline to 4 h was increased by 82.6 ± 64.8%, 137.8 ± 72.1%, and 140.6 ± 52.4% in the MPC, mMPC, and CAS groups, respectively, with no difference between groups (P = 0.548). Phosphorylation of anabolic signaling targets (P70S6KThr389, P70S6KThr421/Ser424, RPS6Ser235/236, RPS6Ser240/244, P90RSKSer380, 4EBP1) were elevated by <3-fold at both 2 and 4 h post exercise in all groups (P < 0.05).
CONCLUSIONS


The amplitude of plasma leucine and EAA concentrations does not modulate the anabolic response to resistance exercise after ingestion of 25 g dairy protein in young men. This trial was registered at http://www.anzctr.org.au/ as ACTRN12617000393358.",2019,The amplitude of plasma leucine and EAA concentrations does not modulate the anabolic response to resistance exercise after ingestion of 25 g dairy protein in young men.,"['Young Men', 'young men', 'Thirty healthy young men (22.5\xa0±']","['primed constant infusions of l-[ring-13C6]-phenylalanine', 'double-blind fashion to consume 25 g mMPC, MPC, or calcium caseinate (CAS', 'Resistance exercise and dietary protein', 'novel mineral modified milk protein concentrate (mMPC), with identical amino acid composition to standard milk protein concentrate (MPC', 'mMPC']","['Plasma EAA concentrations, including leucine', 'Myofibrillar fractional synthetic rate', 'Degree of Aminoacidemia after Dairy Protein Ingestion', 'Postexercise Anabolic Response']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C4517649', 'cui_str': 'Twenty-two point five'}]","[{'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1260969', 'cui_str': 'Ring, device (physical object)'}, {'cui': 'C0031453', 'cui_str': 'L-phenylalanine'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0456638', 'cui_str': '25G (qualifier value)'}, {'cui': 'C0639214', 'cui_str': 'MMPC'}, {'cui': 'C0301465', 'cui_str': 'Calcium caseinate (substance)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0012177', 'cui_str': 'Dietary Proteins'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0026138', 'cui_str': 'Milk Proteins'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0268457', 'cui_str': 'Aminoacidemia'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]",30.0,0.312324,The amplitude of plasma leucine and EAA concentrations does not modulate the anabolic response to resistance exercise after ingestion of 25 g dairy protein in young men.,"[{'ForeName': 'Alex H', 'Initials': 'AH', 'LastName': 'Chan', 'Affiliation': 'Liggins Institute.'}, {'ForeName': 'Randall F', 'Initials': 'RF', 'LastName': ""D'Souza"", 'Affiliation': 'Liggins Institute.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Beals', 'Affiliation': 'Division of Nutritional Sciences.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Zeng', 'Affiliation': 'Liggins Institute.'}, {'ForeName': 'Utpal', 'Initials': 'U', 'LastName': 'Prodhan', 'Affiliation': 'Liggins Institute.'}, {'ForeName': 'Aaron C', 'Initials': 'AC', 'LastName': 'Fanning', 'Affiliation': 'Fonterra Research and Development Centre, Palmerston North, New Zealand.'}, {'ForeName': 'Sally D', 'Initials': 'SD', 'LastName': 'Poppitt', 'Affiliation': 'School of Biological Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Roy J. Carver Biotechnology Center.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Burd', 'Affiliation': 'Division of Nutritional Sciences.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cameron-Smith', 'Affiliation': 'Liggins Institute.'}, {'ForeName': 'Cameron J', 'Initials': 'CJ', 'LastName': 'Mitchell', 'Affiliation': 'Liggins Institute.'}]",The Journal of nutrition,['10.1093/jn/nxz099']
1231,31039052,Addition of Low-Dose Decitabine to Anti-PD-1 Antibody Camrelizumab in Relapsed/Refractory Classical Hodgkin Lymphoma.,"PURPOSE


Anti-programmed death-1 (PD-1) monotherapy induces a high response rate in patients with relapsed/refractory classic Hodgkin lymphoma (cHL), but complete remission (CR) is infrequently observed. As decitabine is known to boost T-cell function, we assessed the safety and efficacy of anti-PD-1 camrelizumab alone versus decitabine-primed camrelizumab in patients with relapsed/refractory cHL.
METHODS


This two-arm, open-label, phase II study enrolled patients with relapsed/refractory cHL who had received at least two lines of previous therapy. Anti-PD-1 treatment-naïve patients were randomly assigned (1:2) to camrelizumab (200 mg) monotherapy or decitabine (10 mg/d, days 1 to 5) plus camrelizumab (200 mg, day 8) combination therapy every 3 weeks. Patients who were previously treated with anti-PD-1 were assigned combination therapy. Primary end point was CR rate and safety.
RESULTS


Overall, 86 patients were enrolled and evaluated for response, with a median follow-up of 14.9 months. In anti-PD-1-naïve patients, CR rate was 32% (six of 19 patients) with camrelizumab monotherapy versus 71% (30 of 42 patients) who were administered decitabine plus camrelizumab ( P  = .003). At the time of analysis, the response duration rate at 6 months was 76% on camrelizumab monotherapy versus 100% on decitabine plus camrelizumab. For patients who were previously treated with anti-PD-1, 28% achieved CR and 24% partial response after decitabine plus camrelizumab. Ten patients maintained a response at more than 6 months and 81% of responders were estimated to have a response at more than 1 year. For both treatments, the most common adverse events were clinically inconsequential cherry hemangiomas and leukocytopenia that were self-limiting.
CONCLUSION


CR rate in patients with relapsed/refractory cHL who were clinically naïve to PD-1 blockade was significantly higher with decitabine plus camrelizumab than with camrelizumab alone. Decitabine plus camrelizumab may reverse resistance to PD-1 inhibitors in patients with relapsed/refractory cHL.",2019,"For both treatments, the most common adverse events were clinically inconsequential cherry hemangiomas and leukocytopenia that were self-limiting.
","['Refractory Classical Hodgkin Lymphoma', 'patients with relapsed/refractory classic Hodgkin lymphoma (cHL', '86 patients were enrolled and evaluated for response, with a median follow-up of 14.9 months', 'Patients who were previously treated with anti-PD-1', 'enrolled patients with relapsed/refractory cHL who had received at least two lines of previous therapy', 'patients with relapsed/refractory cHL', 'Anti-PD-1 treatment-naïve patients']","['decitabine plus camrelizumab', 'Decitabine plus camrelizumab', 'camrelizumab monotherapy', 'open-label', 'camrelizumab', 'camrelizumab (200 mg) monotherapy or decitabine']","['safety and efficacy', 'response duration rate', 'CR rate and safety', 'PD-1 blockade', 'CR rate']","[{'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C1333064', 'cui_str': 'Classical Hodgkin lymphoma (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439658', 'cui_str': 'Classic (qualifier value)'}, {'cui': 'C1266193', 'cui_str': 'Hodgkin lymphoma - category (morphologic abnormality)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0049065', 'cui_str': 'decitabine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}]",86.0,0.043294,"For both treatments, the most common adverse events were clinically inconsequential cherry hemangiomas and leukocytopenia that were self-limiting.
","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Nie', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Chunmeng', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Qingming', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Mei', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Jiejie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Ku', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Meixia', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Xiaojing', 'Initials': 'X', 'LastName': 'An', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Malcolm V', 'Initials': 'MV', 'LastName': 'Brock', 'Affiliation': '2 John Hopkins University, Baltimore, MD.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Bai', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Han', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02151']
1232,31166248,A RANDOMIZED PAIRED-EYE TRIAL OF INTRAVITREAL DEXAMETHASONE IMPLANT FOR CYSTOID MACULAR EDEMA IN RETINITIS PIGMENTOSA.,"PURPOSE


To evaluate the efficacy and safety of intravitreal dexamethasone (DEX) implant in retinitis pigmentosa patients with cystoid macular edema (CME).
METHODS


In this randomized, noncontrolled, paired-eye, single crossover clinical trial, one eye of retinitis pigmentosa patients with bilateral CME with central macular thickness of >250 µm was randomized to intravitreal DEX implant while the fellow eye was observed. Both eyes were started on topical dorzolamide. At Month 6, DEX implant was eligible for both eyes when CME was >250 µm. Patients were followed up until Month 12. Primary outcome measures were the central macular thickness and best-corrected visual acuity changes from baseline at Month 2.
RESULTS


Fourteen patients with bilateral RP-CME were included. Study eyes showed significant central macular thickness decrease (median, -147.5 µm; P = 0.001) and best-corrected visual acuity improvement (median, +6 letters; P = 0.001) at Month 2, but not at Month 6. Intravitreal DEX implant at Month 6 produced comparable efficacy to baseline treatment in 11 fellow eyes and 12 study eyes. Topical dorzolamide did not show significant therapeutic efficacy. During 12 months, elevated intraocular pressure of >21 mmHg and cataract progression were observed in 14.3% and 40.0% of study eyes.
CONCLUSION


Intravitreal DEX implant can both reduce macular thickness and improve vision in RP-CME, while repeated injection is required.",2020,"Study eyes showed significant central macular thickness decrease (median, -147.5 µm; P = 0.001) and best-corrected visual acuity improvement (median, +6 letters; P = 0.001) at Month 2, but not at Month 6.","['11 fellow eyes and 12 study eyes', 'retinitis pigmentosa patients with cystoid macular edema (CME', 'retinitis pigmentosa patients with bilateral CME with central macular thickness of >250 µm', 'Fourteen patients with bilateral RP-CME']","['Intravitreal DEX', 'DEX', 'intravitreal dexamethasone (DEX) implant', 'intravitreal DEX', 'topical dorzolamide', 'Topical dorzolamide']","['macular thickness', 'central macular thickness and best-corrected visual acuity changes', 'central macular thickness decrease', 'best-corrected visual acuity improvement', 'therapeutic efficacy', 'efficacy and safety', 'elevated intraocular pressure of >21 mmHg and cataract progression']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0035334', 'cui_str': 'Pigmentary Retinopathy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024440', 'cui_str': 'Macular Dystrophy, Dominant Cystoid'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C3715152', 'cui_str': '14'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0165590', 'cui_str': 'dorzolamide'}]","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0234708', 'cui_str': 'Raised intraocular pressure (finding)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",14.0,0.0728424,"Study eyes showed significant central macular thickness decrease (median, -147.5 µm; P = 0.001) and best-corrected visual acuity improvement (median, +6 letters; P = 0.001) at Month 2, but not at Month 6.","[{'ForeName': 'Un Chul', 'Initials': 'UC', 'LastName': 'Park', 'Affiliation': 'Department of Ophthalmology, College of Medicine, Seoul National University, Seoul, Korea.'}, {'ForeName': 'Jung Hyun', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Ophthalmology, College of Medicine, Seoul National University, Seoul, Korea.'}, {'ForeName': 'Dae Joong', 'Initials': 'DJ', 'LastName': 'Ma', 'Affiliation': 'Department of Ophthalmology, College of Medicine, Seoul National University, Seoul, Korea.'}, {'ForeName': 'In Hwan', 'Initials': 'IH', 'LastName': 'Cho', 'Affiliation': 'Department of Ophthalmology, College of Medicine, Seoul National University, Seoul, Korea.'}, {'ForeName': 'Baek-Lok', 'Initials': 'BL', 'LastName': 'Oh', 'Affiliation': 'Department of Ophthalmology, College of Medicine, Seoul National University, Seoul, Korea.'}, {'ForeName': 'Hyeong Gon', 'Initials': 'HG', 'LastName': 'Yu', 'Affiliation': 'Department of Ophthalmology, College of Medicine, Seoul National University, Seoul, Korea.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002589']
1233,31864178,Long-term outcomes in patients with BRAF V600-mutant metastatic melanoma receiving dabrafenib monotherapy: Analysis from phase 2 and 3 clinical trials.,"BACKGROUND


Previous analyses of BREAK-2 and BREAK-3 showed that durable outcomes lasting ≥3 years are achievable with dabrafenib in some patients with BRAF V600-mutant metastatic melanoma (MM); however, additional follow-up is needed to fully characterise the long-term impact of dabrafenib in these patients.
METHODS


BREAK-2 was a single-arm phase 2 study evaluating dabrafenib in treatment-naive or previously treated BRAF V600E/K-mutant MM. BREAK-3, a randomised (3:1) phase 3 study, assessed dabrafenib versus dacarbazine in previously untreated unresectable or metastatic BRAF V600E-mutant melanoma. Five-year analyses were performed.
RESULTS


All BREAK-2 patients (N = 92 [V600E, n = 76; V600K, n = 16]) discontinued treatment by the data cutoff. Median follow-up was 13.0 months. In BRAF V600E patients, 5-year progression-free survival (PFS) and overall survival (OS) were 11% and 20%, respectively. Subsequent immunotherapy was received by 22% of patients. In BREAK-3, median follow-up was 17.0 and 12.0 months in the dabrafenib (n = 187) and dacarbazine (n = 63) arms, respectively. Thirty-seven patients (59%) receiving dacarbazine crossed over to dabrafenib following disease progression as per protocol. Five-year PFS was 12% in the dabrafenib arm; all dacarbazine-arm patients progressed or were censored by 5 years. Dabrafenib improved PFS versus dacarbazine, regardless of baseline lactate dehydrogenase levels. Five-year OS rates were 24% and 22% in the dabrafenib and dacarbazine arms, respectively. Subsequent therapy in each arm included anti-CTLA-4 (dabrafenib [24%] and dacarbazine [24%]) and/or anti-PD-1 (8% and 2%) treatment. No new safety signals were observed.
CONCLUSIONS AND RELEVANCE


These data, representing extended follow-up for dabrafenib monotherapy, demonstrate that durable benefit lasting ≥5 years is achievable in a subset of patients.
TRIAL REGISTRATION


ClinicalTrials.gov (BREAK-2, NCT01153763; BREAK-3, NCT01227889).",2020,"Five-year OS rates were 24% and 22% in the dabrafenib and dacarbazine arms, respectively.","['previously untreated unresectable or metastatic BRAF V600E-mutant melanoma', 'patients with BRAF V600-mutant metastatic melanoma (MM', 'patients with BRAF V600-mutant metastatic melanoma receiving']","['dabrafenib versus dacarbazine', 'dabrafenib monotherapy', 'dacarbazine', 'dabrafenib in treatment-naive or previously treated BRAF V600E/K-mutant MM', 'dabrafenib']","['baseline lactate dehydrogenase levels', '5-year progression-free survival (PFS) and overall survival (OS']","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}]","[{'cui': 'C3467876', 'cui_str': 'dabrafenib'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement (procedure)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",37.0,0.387792,"Five-year OS rates were 24% and 22% in the dabrafenib and dacarbazine arms, respectively.","[{'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Hauschild', 'Affiliation': 'University Hospital Schleswig-Holstein, Kiel, Germany. Electronic address: ahauschild@dermatology.uni-kiel.de.'}, {'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Istituto Nazionale Tumori IRCCS Fondazione ""G. Pascale,"" Naples, Italy.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'University Hospital of Essen, Essen, Germany; German Cancer Consortium, Heidelberg, Germany.'}, {'ForeName': 'Jean Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Aix-Marseille University, Marseille, France.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Ribas', 'Affiliation': 'UCLA Jonsson Comprehensive Cancer Center, Los Angeles, CA, USA.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Kiecker', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dutriaux', 'Affiliation': 'Hôpital Saint-André, Bordeaux, France.'}, {'ForeName': 'Lev V', 'Initials': 'LV', 'LastName': 'Demidov', 'Affiliation': 'N.N. Blokhin Russian Cancer Research Center, Moscow, Russia.'}, {'ForeName': 'Céleste', 'Initials': 'C', 'LastName': 'Lebbé', 'Affiliation': 'APHP Dermatology and CIC Department, Hôpital Saint-Louis, INSERM U976, University Paris Diderot, Paris, France.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Maria Sklodowska-Curie Institute - Oncology Center, Warsaw, Poland.'}, {'ForeName': 'Christian U', 'Initials': 'CU', 'LastName': 'Blank', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Gutzmer', 'Affiliation': 'Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Millward', 'Affiliation': 'University of Western Australia, Sir Charles Gairdner Hospital, Perth, WA, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kefford', 'Affiliation': 'Westmead Hospital and Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Haas', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': ""D'Amelio"", 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Gasal', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Bijoyesh', 'Initials': 'B', 'LastName': 'Mookerjee', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Chapman', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.10.033']
1234,31708555,"Second-Generation Visually Guided Laser Balloon Ablation System for Pulmonary Vein Isolation: Learning Curve, Safety and Efficacy　- The MERLIN Registry.","BACKGROUND


Radiofrequency (RF)-based pulmonary vein isolation (PVI) results in a favorable clinical outcome, although its complexity demands a long learning curve. Balloon-based systems have been developed to possibly solve these limitations. The 2nd-generation laser balloon (LB2) offers optimized features for improved tissue contact and visibility. We determined the safety, efficacy and learning curve of the LB2 for PVI.Methods and Results:A total of 45 consecutive patients (89% persistent AF) were prospectively enrolled and divided into 3 groups (T1, T2, T3) of n=15 patients per group. All patients underwent PVI by 2 operators using the LB2. The operators were experienced in RF and cryothermal procedures, but not in laser ablations. A total of 174/177 PVs (98%) were successfully isolated. The median procedure time significantly declined from 132 (114, 158) to 119 (102, 127) and 91 (86, 105) min in T1-3, respectively (P=0.0009). Similarly, the median fluoroscopy time significantly decreased from T1 to T3 (22 (17, 27) vs. 21 (16, 24) vs. 13 (10, 17) min, respectively, P=0.045). Adverse events occurred in 6.7%, with a trend towards a lower complication rate with increasing experience.
CONCLUSIONS


The LB2 was safe and effective for PVI, even for operators without any previous experience in laser balloon-based PVI. Procedure time, left atrial dwelling time and fluoroscopy time decreased after a learning curve of 15 cases.",2019,"The LB2 was safe and effective for PVI, even for operators without any previous experience in laser balloon-based PVI. Procedure time, left atrial dwelling time and fluoroscopy time decreased after a learning curve of 15 cases.","['45 consecutive patients (89% persistent AF', 'Pulmonary Vein Isolation']","['Radiofrequency (RF)-based pulmonary vein isolation (PVI', 'generation laser balloon (LB2', 'LB2', 'Second-Generation Visually Guided Laser Balloon Ablation System']","['Learning Curve, Safety and Efficacy', 'Adverse events', 'median fluoroscopy time', 'left atrial dwelling time and fluoroscopy time', 'safety, efficacy and learning curve of the LB2 for PVI.Methods\u2004and\u2004Results', 'median procedure time', 'complication rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C2936637', 'cui_str': 'Learning Curve'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",45.0,0.0226322,"The LB2 was safe and effective for PVI, even for operators without any previous experience in laser balloon-based PVI. Procedure time, left atrial dwelling time and fluoroscopy time decreased after a learning curve of 15 cases.","[{'ForeName': 'Christian-H', 'Initials': 'CH', 'LastName': 'Heeger', 'Affiliation': 'University Heart Center Lübeck, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein.'}, {'ForeName': 'Huong-Lan', 'Initials': 'HL', 'LastName': 'Phan', 'Affiliation': 'University Heart Center Lübeck, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein.'}, {'ForeName': 'Roza', 'Initials': 'R', 'LastName': 'Meyer-Saraei', 'Affiliation': 'University Heart Center Lübeck, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Fink', 'Affiliation': 'University Heart Center Lübeck, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Sciacca', 'Affiliation': 'University Heart Center Lübeck, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein.'}, {'ForeName': 'Spyridon', 'Initials': 'S', 'LastName': 'Liosis', 'Affiliation': 'University Heart Center Lübeck, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Brüggemann', 'Affiliation': 'University Heart Center Lübeck, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Große', 'Affiliation': 'University Heart Center Lübeck, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein.'}, {'ForeName': 'Bezhad', 'Initials': 'B', 'LastName': 'Fahimi', 'Affiliation': 'University Heart Center Lübeck, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Sano', 'Affiliation': 'University Heart Center Lübeck, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein.'}, {'ForeName': 'Karl-Heinz', 'Initials': 'KH', 'LastName': 'Kuck', 'Affiliation': 'University Heart Center Lübeck, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein.'}, {'ForeName': 'Feifan', 'Initials': 'F', 'LastName': 'Ouyang', 'Affiliation': 'Fuwai Hospital/National Center of Cardiovascular Diseases.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Vogler', 'Affiliation': 'University Heart Center Lübeck, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Eitel', 'Affiliation': 'University Heart Center Lübeck, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein.'}, {'ForeName': 'Roland Richard', 'Initials': 'RR', 'LastName': 'Tilz', 'Affiliation': 'University Heart Center Lübeck, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein.'}]",Circulation journal : official journal of the Japanese Circulation Society,['10.1253/circj.CJ-19-0766']
1235,31155169,Comparing intranasal ketamine with intravenous fentanyl in reducing pain in patients with renal colic: A double-blind randomized clinical trial.,"BACKGROUND


Kidney stones are a fairly common problem that manifests itself as symptoms of acute abdominal and flank pains in patients presenting to emergency departments.
OBJECTIVE


The present study was conducted to compare the analgesic effect of intravenous fentanyl with that of intranasal ketamine in renal colic patients.
METHODS


One mg/kg of intranasal ketamine was administered in the first group, and one μg/kg of intravenous fentanyl in the second group. The pain severity was measured in the patients in terms of a visual analogue scale (VAS) score at the beginning of the study and at minutes 5, 15 and 30, and the medication side-effects were evaluated and recorded.
RESULTS


A total of 130 patients were ultimately assessed in two groups of 65. In the ketamine group, the mean severity of pain was 8.72 ± 1.52 at the beginning of the study (P < 0.001), 5.5 ± 2.97 at minute 5 (P < 0.001), 3.38 ± 3.35 at minute 15 (P = 0.004) and 2.53 ± 3.41 at minute 30 (P = 0.449). In the fentanyl group, this severity was 9.66 ± 88.8 in the beginning of the study (P < 0.001), 7.27 ± 1.37 at minute 5 (P < 0.001), 4.61 ± 1.5 at minute 15 (P = 0.004) and 1.24 ± 1.25 at minute 30 (P = 0.449). The general prevalence of the medication side-effects was 10 (15.4%) in the ketamine group and 1 (1.5%) in the fentanyl group (P = 0.009).
CONCLUSIONS


Ketamine was found to be less effective than fentanyl in controlling renal colic-induced pain, and to be associated with a higher prevalence of side-effects; nevertheless, ketamine can be effective in controlling this pain in conjunction with other medications.",2020,"The general prevalence of the medication side-effects was 10 (15.4%) in the ketamine group and 1 (1.5%) in the fentanyl group (P = 0.009).
","['130 patients were ultimately assessed in two groups of 65', 'patients with renal colic', 'patients presenting to emergency departments', 'renal colic patients']","['ketamine', 'fentanyl', 'intranasal ketamine', 'Ketamine', 'intravenous fentanyl']","['visual analogue scale (VAS) score', 'pain', 'mean severity of pain', 'analgesic effect', 'pain severity']","[{'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0152169', 'cui_str': 'Acute Renal Colic'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}]",130.0,0.114413,"The general prevalence of the medication side-effects was 10 (15.4%) in the ketamine group and 1 (1.5%) in the fentanyl group (P = 0.009).
","[{'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Mozafari', 'Affiliation': 'Assistant professor of Emergency Medicine, Department of Emergency Medicine, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Maleki Verki', 'Affiliation': 'Assistant professor of Emergency Medicine, Department of Emergency Medicine, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: drmalaki676@yahoo.com.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Motamed', 'Affiliation': 'Assistant professor of Emergency Medicine, Department of Emergency Medicine, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Sabouhi', 'Affiliation': 'Emergency Medicine Specialist, Department of Emergency Medicine, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Tirandaz', 'Affiliation': 'Assistant professor of Emergency Medicine, Department of Emergency Medicine, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.05.049']
1236,31155223,An online healthy relationship tool and safety decision aid for women experiencing intimate partner violence (I-DECIDE): a randomised controlled trial.,"BACKGROUND


Evidence for online interventions to help women experiencing intimate partner violence is scarce. We assessed whether an online interactive healthy relationship tool and safety decision aid (I-DECIDE) would increase women's self-efficacy and improve depressive symptoms compared with an intimate partner violence information website.
METHODS


In this two-group pragmatic randomised controlled trial, we enrolled women who had screened positive for any form of intimate partner violence or fear of a partner in the 6 months before recruitment. Women aged 16-50 years currently residing in Australia, who had safe access to a computer and an internet connection, and who answered positively to one of the screening questions in English were eligible for inclusion. Participants were randomly assigned (1:1) by computer to receive either the intervention or control website. The intervention website consisted of modules on healthy relationships, abuse and safety, and relationship priority setting, and a tailored action plan. The control website was a static intimate partner violence information website. As the initial portion of the website containing the baseline questions was identical for both groups, there was no way for women to tell which group they had been allocated to, and the research team were also masked to participant allocation until after analysis of the 12-month data. Data were collected at baseline, immediately after completion of the website, at 6 months, and 12 months. Primary outcomes were mean general self-efficacy score (immediately after website completion, and at 6 months and 12 months) and mean depression score (at 6 months and 12 months). Data analyses were done according to intention-to-treat principles, accounting for missing data, and adjusted for outcome baseline scores. This trial was registered with the Australian New Zealand Clinical Trials Registry, ACTRN 12614001306606.
FINDINGS


Between Jan 16, and Aug 28, 2015, 584 patients registered for the study and were assessed for eligibility. 422 eligible participants were randomly allocated to the intervention group (227 patients) or control group (195 patients). 179 (79%) participants in the intervention group and 156 (80%) participants in the control group completed 12-month follow-up. Mean self-efficacy at 6 months and 12 months was lower for participants in the intervention group than for participants in the control group, although this did not meet the prespecified mean difference (6 months: 27·5 [SD 5·1] vs 28·1 [4·4], imputed mean difference 1·3 [95% CI 0·3 to 2·3]; 12 months: 27·8 [SD 5·4] vs 29·0 [5·0], imputed mean difference 1·6 [95% CI 0·5 to 2·7]). We found no difference between groups in depressive symptoms at 6 months or 12 months (6 months: 22·5 [SD 17·1] vs 24·2 [17·2], imputed mean difference -0·3 [95% CI -3·5 to 3·0]; 12 months: 21·9 [SD 19·3] vs 21·5 [19·3], imputed mean difference -1·9 [95% CI -5·6 to 1·7]). Qualitative findings indicated that participants found the intervention supportive and a motivation for action.
INTERPRETATION


Our findings highlight the need for further research, development, and refinement of online interventions for women experiencing intimate partner violence, particularly into the duration needed for interventions. Although we detected no meaningful differences between groups, our qualitative results indicated that some women find an online tool a helpful source of motivation and support.
FUNDING


Australian Research Council.",2019,"Mean self-efficacy at 6 months and 12 months was lower for participants in the intervention group than for participants in the control group, although this did not meet the prespecified mean difference (6 months: 27·5 [SD 5·1] vs 28·1 [4·4], imputed mean difference 1·3","['1·6', 'Women aged 16-50 years currently residing in Australia, who had safe access to a computer and an internet connection, and who answered positively to one of the screening questions in English were eligible for inclusion', 'women experiencing intimate partner violence', 'enrolled women who had screened positive for any form of intimate partner violence or fear of a partner in the 6 months before recruitment', '422 eligible participants', 'women experiencing intimate partner violence (I-DECIDE', 'Between Jan 16, and Aug 28, 2015, 584 patients registered for the study and were assessed for eligibility']",['intervention or control website'],"['mean depression score', 'Mean self-efficacy', 'depressive symptoms', 'mean general self-efficacy score']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0449379', 'cui_str': 'Connection (attribute)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0585825', 'cui_str': 'Patient registered (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",422.0,0.227019,"Mean self-efficacy at 6 months and 12 months was lower for participants in the intervention group than for participants in the control group, although this did not meet the prespecified mean difference (6 months: 27·5 [SD 5·1] vs 28·1 [4·4], imputed mean difference 1·3","[{'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Hegarty', 'Affiliation': ""Department of General Practice, The University of Melbourne, Melbourne, VIC, Australia; The Royal Women's Hospital, Melbourne, VIC, Australia. Electronic address: k.hegarty@unimelb.edu.au.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Tarzia', 'Affiliation': 'Department of General Practice, The University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Jodie', 'Initials': 'J', 'LastName': 'Valpied', 'Affiliation': 'Department of General Practice, The University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Murray', 'Affiliation': 'eHealth Unit, Department of Primary Care and Population Health, University College London, London, UK.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Humphreys', 'Affiliation': 'Department of Social Work, The University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Taft', 'Affiliation': 'Judith Lumley Centre, La Trobe University, Melbourne, VIC, Australia.'}, {'ForeName': 'Kitty', 'Initials': 'K', 'LastName': 'Novy', 'Affiliation': 'Department of General Practice, The University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Gold', 'Affiliation': 'Department of Population Health, Deakin University, Melbourne, VIC, Australia.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Glass', 'Affiliation': 'School of Nursing, Johns Hopkins University, Baltimore, MD, USA.'}]",The Lancet. Public health,['10.1016/S2468-2667(19)30079-9']
1237,31751163,Health-Related Quality of Life With Carboplatin-Paclitaxel or nab-Paclitaxel With or Without Pembrolizumab in Patients With Metastatic Squamous Non-Small-Cell Lung Cancer.,"PURPOSE


In the phase 3 KEYNOTE-407 study, the addition of pembrolizumab to carboplatin-paclitaxel/nab-paclitaxel significantly improved overall survival, progression-free survival, and objective response rate in patients with previously untreated metastatic squamous non-small-cell lung cancer (NSCLC), with little impact on severe toxicity. We present patient-reported outcomes (PROs) from KEYNOTE-407.
METHODS


Patients were randomly assigned to receive 4 cycles of pembrolizumab 200 mg or placebo once every 3 weeks plus carboplatin plus paclitaxel or nab-paclitaxel, followed by pembrolizumab or placebo for an additional 31 cycles. Health-related quality of life (HRQoL) was evaluated using the European Organisation for Research and Treatment of Cancer Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30) and Quality of Life Questionnaire-Lung Cancer Module 13 (QLQ-LC13). Key PRO endpoints were change from baseline to weeks 9 and 18 (during and after platinum therapy) in the QLQ-C30 global health status/quality of life (GHS/QoL) score and time to deterioration in the composite endpoint of cough, chest pain, or dyspnea from the QLQ-C30 and QLQ-LC13. Two-sided, nominal  P  values are provided.
RESULTS


A total of 554 and 553 patients completed ≥ 1 QLQ-C30 or ≥ 1 QLQ-LC13 assessment, respectively. GHS/QoL score improved for the pembrolizumab-combination group (least squares [LS] mean [95% CI] change from baseline: week 9, 1.8 [-0.9 to 4.4]; week 18, 4.3 [1.7 to 6.9]) and deteriorated in the placebo-combination group (week 9, -1.8 [-4.4 to 0.7]; week 18, -0.57 [-3.3 to 2.2]). Between-group differences were improved for the pembrolizumab-combination group (difference in LS mean scores: week 9, 3.6 [95% CI, 0.3 to 6.9], nominal  P  = .0337; week 18, 4.9 [1.4 to 8.3], nominal  P  = .0060). Median time to deterioration in cough, chest pain, or dyspnea was not reached in either group (hazard ratio, 0.79; 95% CI, 0.58 to 1.06]; nominal  P  = .125).
CONCLUSION


Addition of pembrolizumab to chemotherapy maintained or improved HRQoL measurements relative to baseline and improved HRQoL versus chemotherapy alone at weeks 9 and 18. These results support use of pembrolizumab plus chemotherapy as first-line therapy for metastatic squamous NSCLC.",2020,Addition of pembrolizumab to chemotherapy maintained or improved HRQoL measurements relative to baseline and improved HRQoL versus chemotherapy alone at weeks 9 and 18.,"['Patients', 'metastatic squamous NSCLC', 'Patients With Metastatic Squamous Non-Small-Cell Lung Cancer', 'A total of 554 and 553 patients completed ≥ 1 QLQ-C30 or ≥ 1 QLQ-LC13 assessment, respectively', 'patients with previously untreated metastatic squamous non-small-cell lung cancer (NSCLC']","['pembrolizumab to carboplatin-paclitaxel/nab-paclitaxel', 'pembrolizumab 200 mg or placebo', 'pembrolizumab', 'carboplatin plus paclitaxel or nab-paclitaxel, followed by pembrolizumab or placebo', 'pembrolizumab plus chemotherapy', 'Carboplatin-Paclitaxel or nab-Paclitaxel With or Without Pembrolizumab']","['overall survival, progression-free survival, and objective response rate', 'Median time to deterioration in cough, chest pain, or dyspnea', 'HRQoL measurements', 'GHS/QoL score', 'Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30) and Quality of Life Questionnaire-Lung Cancer Module 13 (QLQ-LC13', 'QLQ-C30 global health status/quality of life (GHS/QoL) score and time to deterioration in the composite endpoint of cough, chest pain, or dyspnea from the QLQ-C30 and QLQ-LC13', 'Health-related quality of life (HRQoL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4509816', 'cui_str': 'Squamous non-small cell lung cancer'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",553.0,0.355644,Addition of pembrolizumab to chemotherapy maintained or improved HRQoL measurements relative to baseline and improved HRQoL versus chemotherapy alone at weeks 9 and 18.,"[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Mazieres', 'Affiliation': 'Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Kowalski', 'Affiliation': 'Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Luft', 'Affiliation': 'Leningrad Regional Clinical Hospital, St Petersburg, Russia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Vicente', 'Affiliation': 'Hospital Universitario Virgen Macarena, Seville, Spain.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Tafreshi', 'Affiliation': 'Wollongong Oncology and University of Wollongong, Wollongong, NSW, Australia.'}, {'ForeName': 'Mahmut', 'Initials': 'M', 'LastName': 'Gümüş', 'Affiliation': 'Istanbul Medeniyet University Hospital, Istanbul, Turkey.'}, {'ForeName': 'Konstantin', 'Initials': 'K', 'LastName': 'Laktionov', 'Affiliation': 'N.N. Blokhin Russian Cancer Research Center, Moscow, Russia.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Hermes', 'Affiliation': 'Universitätsklinikum Tübingen, Tübingen, Germany.'}, {'ForeName': 'Irfan', 'Initials': 'I', 'LastName': 'Cicin', 'Affiliation': 'Trakya University, Edirne, Turkey.'}, {'ForeName': 'Jerónimo', 'Initials': 'J', 'LastName': 'Rodríguez-Cid', 'Affiliation': 'Oncology Center, Medica Sur Hospital, Mexico City, Mexico.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Wilson', 'Affiliation': 'Humber River Regional Hospital, Toronto, ON, Canada.'}, {'ForeName': 'Terufumi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Rodryg', 'Initials': 'R', 'LastName': 'Ramlau', 'Affiliation': 'Poznan University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Novello', 'Affiliation': 'University of Turin, AOU San Luigi, Orbassano, Italy.'}, {'ForeName': 'Sreekanth', 'Initials': 'S', 'LastName': 'Reddy', 'Affiliation': 'Northside Hospital Cancer Institute, Atlanta, GA.'}, {'ForeName': 'Hans-Georg', 'Initials': 'HG', 'LastName': 'Kopp', 'Affiliation': 'Robert-Bosch Cancer Center, Klinik Schillerhöhe, Gerlingen, Germany.'}, {'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Piperdi', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Burke', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Paz-Ares', 'Affiliation': 'Hospital Universitario 12 de Octubre, CNIO-H12o Lung Cancer Unit, Universidad Complutense and Ciberonc, Madrid, Spain.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01348']
1238,31130005,A Pilot Study of a Sleep Intervention Delivered through Group Prenatal Care to Overweight and Obese Women.,"OBJECTIVES


We sought to investigate the feasibility of a behavioral sleep intervention for insomnia, delivered through group prenatal care and the relationship of this intervention to improvements in insomnia symptoms and sleep quality.
PARTICIPANTS


Women receiving prenatal care and reporting a pre-pregnancy BMI of ≥25 kg/m 2  and sleep duration of <6.5 h per night.
METHODS


Participants were randomized to group prenatal care or group prenatal care with a behavioral sleep intervention, adapted from cognitive behavioral therapy for insomnia (CBT-I) online program Go! to Sleep®. In the second trimester (T1), late third trimester (T2) and 6-8 weeks postpartum (T3) study assessments were completed including the  Insomnia Severity Index, Pittsburgh Sleep Quality Index , fasting glucose and insulin and weight and height. Data were analyzed using independent samples t-tests, chi-square tests, correlations, and two-way repeated measures ANOVA where appropriate. P < .05 was set as the level of significance.
RESULTS


From May 2014 to April 2015, 311 women were evaluated for inclusion and 53 women were randomized to participate (27 intervention; 26 control), 15% were lost to follow up. The intervention group had lower third trimester and postpartum levels of moderate to severe insomnia (T2 50.0% vs 85.0% (p = .018) and T3 13.6% vs 52.4% (p-.008)) and mean insomnia severity scores (T2 (14.7 (±6.6) vs 19.3 (± 6.0) p = .02) and T3 (9.7 (±5.4) vs 15.1(±7.2) p = .01)) when compared to the control group.
CONCLUSION


A randomized controlled trial of a behavioral sleep intervention for insomnia delivered through group prenatal care led to improvements in insomnia symptoms.",2020,The intervention group had lower third trimester and postpartum levels of moderate to severe insomnia (T2 50.0% vs 85.0% (p = .018) and T3 13.6% vs 52.4% (p-.008)) and mean insomnia severity scores (T2 (14.7 (±6.6) vs 19.3 (± 6.0) p = .02) and T3 (9.7 (±5.4) vs 15.1(±7.2),"['Women receiving prenatal care and reporting a pre-pregnancy BMI of ≥25 kg/m 2  and sleep duration of <6.5 h per night', 'Participants ', 'to Overweight and Obese Women', 'From May 2014 to April 2015, 311 women were evaluated for inclusion and 53 women']","['prenatal care or group prenatal care with a behavioral sleep intervention, adapted from cognitive behavioral therapy for insomnia (CBT-I) online program Go! to Sleep®', 'behavioral sleep intervention', 'Sleep Intervention Delivered through Group Prenatal Care']","['lower third trimester and postpartum levels of moderate to severe insomnia', 'mean insomnia severity scores', 'Insomnia Severity Index, Pittsburgh Sleep Quality Index , fasting glucose and insulin and weight and height', 'insomnia symptoms and sleep quality', 'insomnia symptoms']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0442051', 'cui_str': 'Lower third (qualifier value)'}, {'cui': 'C0032982', 'cui_str': 'Pregnancy Trimesters'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",311.0,0.0605809,The intervention group had lower third trimester and postpartum levels of moderate to severe insomnia (T2 50.0% vs 85.0% (p = .018) and T3 13.6% vs 52.4% (p-.008)) and mean insomnia severity scores (T2 (14.7 (±6.6) vs 19.3 (± 6.0) p = .02) and T3 (9.7 (±5.4) vs 15.1(±7.2),"[{'ForeName': 'Mary Ashley', 'Initials': 'MA', 'LastName': 'Cain', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, University of South Florida Morsani College of Medicine , Tampa, Florida, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Brumley', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of midwifery, University of South Florida Morsani College of Medicine , Tampa, Florida, USA.'}, {'ForeName': 'Adetola', 'Initials': 'A', 'LastName': 'Louis-Jacques', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, University of South Florida Morsani College of Medicine , Tampa, Florida, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Drerup', 'Affiliation': 'Department of sleep disorders, Cleveland Clinic Sleep Disorders Center , Cleveland, OH.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Stern', 'Affiliation': 'Department of Child and Family Studies, University of South Florida , Tampa.'}, {'ForeName': 'Judette M', 'Initials': 'JM', 'LastName': 'Louis', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, University of South Florida Morsani College of Medicine , Tampa, Florida, USA.'}]",Behavioral sleep medicine,['10.1080/15402002.2019.1613995']
1239,31122152,Does feedback improve psychotherapy outcomes compared to treatment-as-usual for adults and youth?,"Objective : Client-informed outcome feedback has consistently been shown to enhance psychotherapy outcomes for adults, particularly for clients at risk of treatment failure. However, there is a paucity of studies examining feedback in youth psychotherapy. Specifically, there is no research examining the feedback effect of the Youth-Outcome Questionnaire [Burlingame, G. M., Wells, M. G., & Lambert, M. J. (1996).  The youth outcome questionnaire . Stevenson, MD: American Professional Credentialing Services.], despite the dominance of the adult version of the measure (Outcome Questionnaire-45 [Lambert, M. J., & Burlingame, G. M. (1996).  Outcome questionnaire 45.2 . Wilmington, DE: American Professional Credentialing Services.]) in adult feedback studies.  Method :  The effectiveness results for adult ( N  = 398) and youth clients ( N  = 397) attending psychotherapy at two psychology training clinics are presented and benchmarked against treatment-as-usual (for adults and youth) and feedback (for adults).  Results : Psychotherapy with a feedback-informed approach was more effective than treatment-as-usual benchmarks, with 50% of adults and 64% of youth significantly improving after psychotherapy. Rates of adult improvement were similar to feedback-informed benchmarks, although the current sample had a higher rate of deterioration. There are no previously identified feedback-informed benchmarks for the Y-OQ, making this sample the first benchmark for future studies.  Conclusions : Results support the benefits of feedback at enhancing psychotherapy outcomes for adults, and replicate this finding in a youth sample. Results also replicate that trainee psychotherapists can be as effective as licenced psychotherapists.",2020,"Rates of adult improvement were similar to feedback-informed benchmarks, although the current sample had a higher rate of deterioration.","[' N\u2009 =\u2009398) and youth clients ( N \u2009=\u2009397) attending psychotherapy at two psychology training clinics are presented and benchmarked against treatment-as-usual (for adults and youth) and feedback (for adults', 'adult']",[],['rate of deterioration'],"[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0525063', 'cui_str': 'Best Practice Analysis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]",[],[],,0.0520111,"Rates of adult improvement were similar to feedback-informed benchmarks, although the current sample had a higher rate of deterioration.","[{'ForeName': 'Katelyn M', 'Initials': 'KM', 'LastName': 'Dyason', 'Affiliation': 'Griffith University, Queensland, Australia.'}, {'ForeName': 'Dianne C', 'Initials': 'DC', 'LastName': 'Shanley', 'Affiliation': 'Griffith University, Queensland, Australia.'}, {'ForeName': 'Analise', 'Initials': 'A', 'LastName': ""O'Donovan"", 'Affiliation': 'Griffith University, Queensland, Australia.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Low-Choy', 'Affiliation': 'Griffith University, Queensland, Australia.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2019.1620367']
1240,31912649,Pre-pregnancy iodized salt improved children's cognitive development in randomized trial in Ethiopia.,"The overarching Ethiopia project examined the effects of early market introduction of iodized salt on the growth and mental development of young children. Sixty districts were randomly assigned to intervention (early market access to iodized salt) or control (later access through market forces), and one community per district was randomly chosen as the sampling unit. For this project, 22 of the districts were included. The participants were 1,220 pregnant women who conceived after the intervention began. When their children were 2 to 13 months old, field staff collected information on household sociodemographic status and iodized salt intake, child stimulation, maternal depression symptoms, children's diet, anthropometry, urinary iodine concentration (UIC), hemoglobin, and mental development scores (Bayley III scales). Fewer mothers prepartum (28% vs. 41%, p < .05) and their children (13% vs. 20%, p < .05) were iodine deficient (UIC <50 μg/L) in the intervention compared with the control group. The intervention children had higher cognitive scores (33.3 ± 0.3 vs. 32.6 ± 0.3; Δ = 0.6; 95% CI [0.0, 1.3]; d = 0.17; p = .01; 4 IQ points) than their controls. The other Bayley subscale scores did not differ from control children. The intervention group had a higher child stimulation (22.7 ± 0.2 vs. 22.1 ± 0.2; Δ = 0.5; 95% CI [0.02, 0.89]; d = 0.17; p = .01) but not growth indicators (weight-for-age z score, length-for-age z score, and weight-for-length z score: -1.1 ± 0.1 vs. -1.1 ± 0.1, -1.7 ± 0.1 vs. -1.7 ± 0.1; -0.2 ± 0.1 vs. -0.1 ± 0.1, respectively, all p > .05) compared with their controls. Iodized salt intake improved iodine status of both pregnant women and their children and also child cognitive development.",2020,"Fewer mothers prepartum (28% vs. 41%, p < .05) and their children (13% vs. 20%, p < .05)","['Sixty districts', '1,220 pregnant women who conceived after the intervention began', 'young children', ""children's cognitive development in randomized trial in Ethiopia""]","['Pre-pregnancy iodized salt', 'intervention (early market access to iodized salt) or control (later access through market forces', 'Iodized salt intake', 'iodized salt']","['higher cognitive scores', 'iodine status', ""household sociodemographic status and iodized salt intake, child stimulation, maternal depression symptoms, children's diet, anthropometry, urinary iodine concentration (UIC), hemoglobin, and mental development scores (Bayley III scales"", 'Bayley subscale scores']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0015024', 'cui_str': 'Federal Democratic Republic of Ethiopia'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1318228', 'cui_str': 'Market (environment)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0063758', 'cui_str': 'iodinated salt'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0063758', 'cui_str': 'iodinated salt'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0222045'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}]",1220.0,0.0256268,"Fewer mothers prepartum (28% vs. 41%, p < .05) and their children (13% vs. 20%, p < .05)","[{'ForeName': 'Husein', 'Initials': 'H', 'LastName': 'Mohammed', 'Affiliation': 'Nutrition and Food Science Department, University of Ghana, Accra, Ghana.'}, {'ForeName': 'Grace S', 'Initials': 'GS', 'LastName': 'Marquis', 'Affiliation': 'School of Dietetics and Human Nutrition, McGill University, Quebec, Canada.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Aboud', 'Affiliation': 'Department of Psychology, McGill University, Quebec, Canada.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Bougma', 'Affiliation': 'School of Dietetics and Human Nutrition, McGill University, Quebec, Canada.'}, {'ForeName': 'Aregash', 'Initials': 'A', 'LastName': 'Samuel', 'Affiliation': 'Food Sciences and Nutrition Research Directorate, Ethiopian Public Health Institute, Addis Ababa, Ethiopia.'}]",Maternal & child nutrition,['10.1111/mcn.12943']
1241,29583056,Effect of an educational program based on cognitive behavioral techniques on fear of childbirth and the birth process.,"Objective:  This study determined the effect of an educational program based on cognitive behavioral techniques (CBT) provided for pregnant women to address their fear of childbirth.  Methods:  This study was conducted experimentally using pretest-posttest and a control group. A total of 111 Turkish pregnant women were recruited with 52 in the intervention group and 59 in the control group. The intervention group attended the educational program on coping with childbirth fears based on CBT, which took 3 weeks over six sessions. The Wijma Delivery Expectancy/Experience Questionnaire, version-A (W-DEQ-A) was administered to both groups as the posttest. The researchers monitored the pregnant women's labor and delivery and the State Anxiety Inventory (SAI), Numeric Pain Rating Scale (NPRS) and Birth Process Evaluation Form were completed.  Results:  The post-education W-DEQ-A score was 63.5 in the control group and 39.4 in the intervention group ( p  < .001). Their labor pain was lower, the second stage of labor was shorter and birth was more satisfactory for the intervention group than for the control group ( p  < .05). The CBT-based educational program and pain severity during childbirth were the significant predictors of satisfaction with childbirth ( β  = 0.354;  β  = -0.324, respectively;  p  < .05 for all).  Conclusions:  The CBT-based educational program on coping with childbirth fears reduced pregnant women's fear of childbirth and positively affected their birth experience.",2019,A score was 63.5 in the control group and 39.4 in the intervention group ( p  < .001).,"['pregnant women to address their fear of childbirth', '111 Turkish pregnant women were recruited with 52 in the intervention group and 59 in the control group']","['educational program based on cognitive behavioral techniques', 'educational program based on cognitive behavioral techniques (CBT', 'educational program on coping with childbirth fears based on CBT', 'CBT-based educational program']","['fear of childbirth and the birth process', 'Wijma Delivery Expectancy/Experience Questionnaire, version-A (W-DEQ-A', 'labor pain', ""pregnant women's labor and delivery and the State Anxiety Inventory (SAI), Numeric Pain Rating Scale (NPRS) and Birth Process Evaluation""]","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0522187', 'cui_str': 'Tocophobia (finding)'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0554967', 'cui_str': 'Turkish (NMO) (ethnic group)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1148523', 'cui_str': 'Childbirth'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]","[{'cui': 'C0522187', 'cui_str': 'Tocophobia (finding)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0474368', 'cui_str': 'Labor Pain'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0222045'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",111.0,0.0234724,A score was 63.5 in the control group and 39.4 in the intervention group ( p  < .001).,"[{'ForeName': 'Tuba', 'Initials': 'T', 'LastName': 'Uçar', 'Affiliation': 'a Department of Midwifery , İnönü University , Malatya , Turkey.'}, {'ForeName': 'Zehra', 'Initials': 'Z', 'LastName': 'Golbasi', 'Affiliation': 'b Department of Nursing , Cumhuriyet University , Sivas , Turkey.'}]",Journal of psychosomatic obstetrics and gynaecology,['10.1080/0167482X.2018.1453800']
1242,31122495,"Safety of the tau-directed monoclonal antibody BIIB092 in progressive supranuclear palsy: a randomised, placebo-controlled, multiple ascending dose phase 1b trial.","BACKGROUND


Progressive supranuclear palsy is a rare neurodegenerative disease associated with dysfunctional tau protein. BIIB092 is a humanised monoclonal antibody that binds to N-terminal tau and is thus being assessed as a potential novel treatment for progressive supranuclear palsy. We aimed to investigate the safety and tolerability of BIIB092 in individuals with progressive supranuclear palsy.
METHODS


This 12-week, double-blind, randomised, placebo-controlled, multiple ascending dose, phase 1b trial was done at 13 outpatient sites in the USA. Participants aged 41-86 years with probable or possible progressive supranuclear palsy with a score of 20 or greater on the Mini-Mental State Examination (MMSE) were enrolled. Three BIIB092 dose escalation cohorts (150 mg, 700 mg, or 2100 mg; eight participants per cohort) were tested sequentially. For each dose cohort, the first two participants were randomly assigned by a computer-generated scheme to receive either BIIB092 or placebo intravenously every 4 weeks for 57 days. After 2 days, the six remaining participants in each cohort were randomly assigned (5:1) to receive BIIB092 or placebo for 57 days. An additional expansion panel of 24 patients was randomly assigned (3:1) to receive 2100 mg or placebo every 4 weeks for 57 days. All participants were followed up to day 85. The primary outcome was safety, which was analysed in the treated population (all enrolled participants who received at least one dose of the study drug). This trial is registered with ClinicalTrials.gov, NCT02460094.
FINDINGS


Between Oct 2, 2015, and Oct 19, 2016, 48 participants were enrolled and randomly assigned to the BIIB092 (n=36) and placebo (n=12) groups. No apparent demographic differences were observed between the two groups at baseline. All 48 participants completed the treatment phase of the study. Adverse events were generally mild to moderate in severity; the most common in the placebo and BIIB092 groups were falls (in two [17%] of 12 patients and in ten [28%] of 36 patients), urinary tract infections (in one [8%] of 12 and in six [17%] of 36), contusions (in one [8%] of 12 and in five [14%] of 36), and headaches (in none and in five [14%] of 36). Four serious adverse events resulting in admission to hospital were reported in three participants who received BIIB092 2100 mg: two severe adverse events of urinary tract infection, one severe adverse event of change in mental status, and one moderate adverse event of aspiration pneumonia. None was considered to be related to the study drug, all were resolved, and no deaths were reported.
INTERPRETATION


Repeated administration of the anti-tau monoclonal antibody BIIB092, at doses of up to 2100 mg, appears to be well tolerated in participants with progressive supranuclear palsy. Results of this phase 1b trial have informed the design of the ongoing phase 2 PASSPORT (NCT03068468) study to examine the efficacy and safety of BIIB092.
FUNDING


Bristol-Myers Squibb, Biogen.",2019,"Four serious adverse events resulting in admission to hospital were reported in three participants who received BIIB092 2100 mg: two severe adverse events of urinary tract infection, one severe adverse event of change in mental status, and one moderate adverse event of aspiration pneumonia.","['Participants aged 41-86 years with probable or possible progressive supranuclear palsy with a score of 20 or greater on the Mini-Mental State Examination (MMSE) were enrolled', 'Between Oct 2, 2015, and Oct 19, 2016, 48 participants were enrolled and randomly assigned to the BIIB092 (n=36) and', 'progressive supranuclear palsy', 'participants with progressive supranuclear palsy', 'individuals with progressive supranuclear palsy', '24 patients', 'All 48 participants completed the treatment phase of the study']","['BIIB092 or placebo', 'placebo', 'tau-directed monoclonal antibody BIIB092']","['Adverse events', 'safety and tolerability', 'severe adverse events of urinary tract infection, one severe adverse event of change in mental status, and one moderate adverse event of aspiration pneumonia', 'headaches', 'urinary tract infections']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0038868', 'cui_str': 'Steele-Richardson-Olszewski Disease'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0278060', 'cui_str': 'Mental status'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0032290', 'cui_str': 'Aspiration Pneumonia'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}]",48.0,0.474552,"Four serious adverse events resulting in admission to hospital were reported in three participants who received BIIB092 2100 mg: two severe adverse events of urinary tract infection, one severe adverse event of change in mental status, and one moderate adverse event of aspiration pneumonia.","[{'ForeName': 'Adam L', 'Initials': 'AL', 'LastName': 'Boxer', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Irfan', 'Initials': 'I', 'LastName': 'Qureshi', 'Affiliation': 'Bristol-Myers Squibb, Lawrenceville, NJ, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ahlijanian', 'Affiliation': 'Bristol-Myers Squibb, Lawrenceville, NJ, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Grundman', 'Affiliation': 'Global R&D Partners, LLC, San Diego, CA, USA; University of California, San Diego, CA, USA.'}, {'ForeName': 'Lawrence I', 'Initials': 'LI', 'LastName': 'Golbe', 'Affiliation': 'Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Litvan', 'Affiliation': 'University of California, San Diego, CA, USA.'}, {'ForeName': 'Lawrence S', 'Initials': 'LS', 'LastName': 'Honig', 'Affiliation': 'Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Tuite', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Nikolaus R', 'Initials': 'NR', 'LastName': 'McFarland', 'Affiliation': 'University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Padraig', 'Initials': 'P', 'LastName': ""O'Suilleabhain"", 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Xie', 'Affiliation': 'University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Giridhar S', 'Initials': 'GS', 'LastName': 'Tirucherai', 'Affiliation': 'Bristol-Myers Squibb, Lawrenceville, NJ, USA.'}, {'ForeName': 'Clifford', 'Initials': 'C', 'LastName': 'Bechtold', 'Affiliation': 'Bristol-Myers Squibb, Lawrenceville, NJ, USA.'}, {'ForeName': 'Yvette', 'Initials': 'Y', 'LastName': 'Bordelon', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Geldmacher', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Murray', 'Initials': 'M', 'LastName': 'Grossman', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Isaacson', 'Affiliation': 'Boca Raton Institute for Neurodegenerative Disorders, Boca Raton, FL, USA.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Zesiewicz', 'Affiliation': 'University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Olsson', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Kumar Kandadi', 'Initials': 'KK', 'LastName': 'Muralidharan', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Danielle L', 'Initials': 'DL', 'LastName': 'Graham', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': ""O'Gorman"", 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Samantha Budd', 'Initials': 'SB', 'LastName': 'Haeberlein', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Tien', 'Initials': 'T', 'LastName': 'Dam', 'Affiliation': 'Biogen, Cambridge, MA, USA. Electronic address: tien.dam@biogen.com.'}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30139-5']
1243,31748198,Does telephone-delivered exercise advice and support by physiotherapists improve pain and/or function in people with knee osteoarthritis? Telecare randomised controlled trial.,"OBJECTIVE


Evaluate a physiotherapist-led telephone-delivered exercise advice and support intervention for people with knee osteoarthritis.
METHODS


Participant-blinded, assessor-blinded randomised controlled trial. 175 people were randomly allocated to (1) existing telephone service (≥1 nurse consultation for self-management advice) or (2) exercise advice and support (5-10 consultations with a physiotherapist trained in behaviour change for a personalised strengthening and physical activity programme) plus the existing service. Primary outcomes were overall knee pain (Numerical Rating Scale, range 0-10) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index, range 0-68) at 6 months. Secondary outcomes, cost-effectiveness and 12-month follow-up were included.
RESULTS


165 (94%) and 158 (90%) participants were retained at 6 and 12 months, respectively. At 6 months, exercise advice and support resulted in greater improvement in function (mean difference 4.7 (95% CI 1.0 to 8.4)), but not overall pain (0.7, 0.0 to 1.4). Eight of 14 secondary outcomes favoured exercise advice and support at 6 months, including pain on daily activities, walking pain, pain self-efficacy, global improvements across multiple domains (overall improvement, improved pain, improved function and improved physical activity) and satisfaction. By 12 months, most outcomes were similar between groups. Exercise advice and support cost $A514/participant and did not save other health service resources.
CONCLUSION


Telephone-delivered physiotherapist-led exercise advice and support modestly improved physical function but not the co-primary outcome of knee pain at 6 months. Functional benefits were not sustained at 12 months. The clinical significance of this effect is uncertain.
TRIAL REGISTRATION NUMBER


Australian New Zealand Clinical Trials Registry (#12616000054415).",2020,"Eight of 14 secondary outcomes favoured exercise advice and support at 6 months, including pain on daily activities, walking pain, pain self-efficacy, global improvements across multiple domains (overall improvement, improved pain, improved function and improved physical activity) and satisfaction.","['people with knee osteoarthritis', '175 people']","['physiotherapist-led telephone-delivered exercise advice and support intervention', 'Telephone-delivered physiotherapist-led exercise advice', 'existing telephone service (≥1 nurse consultation for self-management advice) or (2) exercise advice and support (5-10 consultations with a physiotherapist trained in behaviour change for a personalised strengthening and physical activity programme) plus the existing service', 'telephone-delivered exercise advice and support by physiotherapists']","['Functional benefits', 'function', 'physical function', 'overall pain', 'overall knee pain (Numerical Rating Scale, range 0-10) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index, range 0-68', 'exercise advice and support at 6 months, including pain on daily activities, walking pain, pain self-efficacy, global improvements across multiple domains (overall improvement, improved pain, improved function and improved physical activity) and satisfaction', 'knee pain', 'cost-effectiveness and 12-month follow-up were included', 'pain and/or function']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C4517605', 'cui_str': '175'}]","[{'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0222045'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",175.0,0.203309,"Eight of 14 secondary outcomes favoured exercise advice and support at 6 months, including pain on daily activities, walking pain, pain self-efficacy, global improvements across multiple domains (overall improvement, improved pain, improved function and improved physical activity) and satisfaction.","[{'ForeName': 'Rana S', 'Initials': 'RS', 'LastName': 'Hinman', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, The University of Melbourne, Melbourne, Victoria, Australia ranash@unimelb.edu.au.'}, {'ForeName': 'Penny K', 'Initials': 'PK', 'LastName': 'Campbell', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Belinda J', 'Initials': 'BJ', 'LastName': 'Lawford', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Briggs', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Janette', 'Initials': 'J', 'LastName': 'Gale', 'Affiliation': 'HealthChange Australia, Melbourne, Victoria, Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Bills', 'Affiliation': 'HealthChange Australia, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Kasza', 'Affiliation': 'School of Public Health and Preventative Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Harris', 'Affiliation': 'Centre for Health Economics, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Simon D', 'Initials': 'SD', 'LastName': 'French', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Bunker', 'Affiliation': 'Medibank Private, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Forbes', 'Affiliation': 'School of Public Health and Preventative Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Kim L', 'Initials': 'KL', 'LastName': 'Bennell', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, The University of Melbourne, Melbourne, Victoria, Australia.'}]",British journal of sports medicine,['10.1136/bjsports-2019-101183']
1244,31748705,Genetic factors associated with elevation of uric acid after treatment with thiazide-like diuretic in patients with essential hypertension.,"We investigated changes in blood pressure (BP) and metabolic adverse effects, especially elevation of uric acid (UA), after treatment with a thiazide-like diuretic (TD) in patients with essential hypertension. Furthermore, the role of genetic factors in the elevation of UA by TD was assessed by a 500 K SNP DNA microarray. The subjects included 126 hypertensive patients (57 women and 69 men, mean age 59 ± 12 years) who registered for the GEANE (Gene Evaluation for ANtihypertensive Effects) study. After one month of the nontreatment period, TD, indapamide, angiotensin II receptor antagonist valsartan, and Ca channel blocker amlodipine were administered to all patients for 3 months each in a randomized crossover manner. BP, renal function, serum UA level, and electrolytes were measured at baseline and at the end of each treatment period. Single nucleotide polymorphisms (SNPs) associated with UA elevation after treatment with indapamide were investigated by a genome-wide association study (GWAS). Indapamide significantly decreased both office and home BP levels. Treatment with indapamide also significantly reduced the estimated glomerular filtration rate and serum potassium and increased serum UA. Patients whose UA level increased more than 1 mg/dl showed significantly higher baseline office SBP and plasma glucose and showed greater decline in renal function compared with those who showed less UA increase (<1 mg/dl). Some SNPs strongly associated with an increase in UA after treatment with indapamide were identified. This study is the first report on SNPs associated with UA elevation after TD treatment. This information may be useful for the prevention of adverse effects after treatment with TD.",2020,Patients whose UA level increased more than 1 mg/dl showed significantly higher baseline office SBP and plasma glucose and showed greater decline in renal function compared with those who showed less UA increase (<1 mg/dl).,"['patients with essential hypertension', '126 hypertensive patients (57 women and 69 men, mean age 59\u2009±\u200912 years) who registered for the GEANE (Gene Evaluation for ANtihypertensive Effects) study']","['thiazide-like diuretic (TD', 'indapamide', 'TD, indapamide, angiotensin II receptor antagonist valsartan, and Ca channel blocker amlodipine', 'thiazide-like diuretic', 'Indapamide']","['estimated glomerular filtration rate and serum potassium and increased serum UA', 'BP, renal function, serum UA level, and electrolytes', 'renal function', 'office and home BP levels', 'UA level', 'UA', 'blood pressure (BP) and metabolic adverse effects, especially elevation of uric acid (UA', 'baseline office SBP and plasma glucose']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085580', 'cui_str': 'Essential Hypertension'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0541746', 'cui_str': 'Thiazides'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C0021186', 'cui_str': 'Indapamide'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II Receptor Blockers'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0439799', 'cui_str': 'Channel (qualifier value)'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}]","[{'cui': 'C3811844'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0013832', 'cui_str': 'Electrolytes'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}]",57.0,0.0446698,Patients whose UA level increased more than 1 mg/dl showed significantly higher baseline office SBP and plasma glucose and showed greater decline in renal function compared with those who showed less UA increase (<1 mg/dl).,"[{'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Ohta', 'Affiliation': 'Division of Hypertension and Nephrology, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Kamide', 'Affiliation': 'Division of Hypertension and Nephrology, National Cerebral and Cardiovascular Center, Osaka, Japan. kamide@sahs.med.osaka-u.ac.jp.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Hanada', 'Affiliation': 'Research Institute, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Shigeto', 'Initials': 'S', 'LastName': 'Morimoto', 'Affiliation': 'Department of Geriatric Medicine, Kanazawa Medical University, Ishishikawa, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Nakahashi', 'Affiliation': 'Department of Geriatric Medicine, Kanazawa Medical University, Ishishikawa, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Takiuchi', 'Affiliation': 'Department of Cardiology, Higashi-Takarazuka Satoh Hospital, Hyogo, Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Ishimitsu', 'Affiliation': 'Department of Hypertension and Cardiorenal Medicine, Dokkyo University School of Medicine, Tochigi, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Tsuchihashi', 'Affiliation': 'Steel Memorial Yawata Hospital, Fukuoka, Japan.'}, {'ForeName': 'Masayoshi', 'Initials': 'M', 'LastName': 'Soma', 'Affiliation': 'Division of General Medicine, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Tomohiro Katsuya', 'Affiliation': 'Department of Geriatric and General Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Sugimoto', 'Affiliation': 'Department of Geriatric and General Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Rakugi', 'Affiliation': 'Department of Geriatric and General Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Oukura', 'Affiliation': 'Department of Integrated Medicine and Informatics, University Graduate School of Medicine, Ehime, Japan.'}, {'ForeName': 'Jitsuo', 'Initials': 'J', 'LastName': 'Higaki', 'Affiliation': 'Department of Integrated Medicine and Informatics, University Graduate School of Medicine, Ehime, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Matsuura', 'Affiliation': 'Saiseikai Kure Hospital, Hiroshima, Japan.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Shinagawa', 'Affiliation': 'Japanese Red Cross Nagasaki Atomic Bomb Hospital, Nagasaki, Japan.'}, {'ForeName': 'Yosikazu', 'Initials': 'Y', 'LastName': 'Miwa', 'Affiliation': 'Departments of Clinical Pharmacology, Kyushu University Graduate School of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Sasaguri', 'Affiliation': 'Departments of Clinical Pharmacology, Kyushu University Graduate School of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Michiya', 'Initials': 'M', 'LastName': 'Igase', 'Affiliation': 'Geriatric Medicine, Ehime University Graduate School of Medicine, Ehime, Japan.'}, {'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Miki', 'Affiliation': 'Geriatric Medicine, Ehime University Graduate School of Medicine, Ehime, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Takeda', 'Affiliation': 'Kyotokojohokenkai Hospital, Kyoto, Japan.'}, {'ForeName': 'Katsuhiro', 'Initials': 'K', 'LastName': 'Higashiura', 'Affiliation': 'Second Department of Internal Medicine, Sapporo Medical University School of Medicine, Hokkaido, Japan.'}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Shimamoto', 'Affiliation': 'Second Department of Internal Medicine, Sapporo Medical University School of Medicine, Hokkaido, Japan.'}, {'ForeName': 'Ritsuko', 'Initials': 'R', 'LastName': 'Katabuchi', 'Affiliation': 'National Fukuoka-Higashi Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Ueno', 'Affiliation': 'National Fukuoka-Higashi Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Naonaga', 'Initials': 'N', 'LastName': 'Hosomi', 'Affiliation': 'Department of Neurology, Hiroshima University Graduate School of Medicine, Hiroshima, Japan.'}, {'ForeName': 'Johji', 'Initials': 'J', 'LastName': 'Kato', 'Affiliation': 'Frontier Science Research Center, University of Miyazaki, Miyazaki, Japan.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Komai', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Kawasaki Medical School, Okayama, Japan.'}, {'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Kojima', 'Affiliation': 'National Hospital Organization Shizuoka Medical Center, Shizuoka, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Sase', 'Affiliation': 'Clinical Pharmacology, Juntendo University, Tokyo, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Iwashima', 'Affiliation': 'Division of Hypertension and Nephrology, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Fumiki', 'Initials': 'F', 'LastName': 'Yoshihara', 'Affiliation': 'Division of Hypertension and Nephrology, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Horio', 'Affiliation': 'Division of Hypertension and Nephrology, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Satoko', 'Initials': 'S', 'LastName': 'Nakamura', 'Affiliation': 'Division of Hypertension and Nephrology, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Nakahama', 'Affiliation': 'Division of Hypertension and Nephrology, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Miyata', 'Affiliation': 'Research Institute, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Yuhei', 'Initials': 'Y', 'LastName': 'Kawano', 'Affiliation': 'Division of Hypertension and Nephrology, National Cerebral and Cardiovascular Center, Osaka, Japan.'}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-019-0356-x']
1245,30693573,"JNJ-4178 (AL-335, Odalasvir, and Simeprevir) for 6 or 8 Weeks in Hepatitis C Virus-Infected Patients Without Cirrhosis: OMEGA-1.","The combination of three direct-acting antiviral agents (AL-335, odalasvir, and simeprevir: JNJ-4178 regimen) for 6 or 8 weeks demonstrated good efficacy and safety in a phase IIa study in chronic hepatitis C virus (HCV) genotype (GT)-1-infected patients without cirrhosis and has now been evaluated in a larger phase IIb study, OMEGA-1. This multicenter, randomized, open-label study (NCT02765490) enrolled treatment-naïve and interferon (±ribavirin) treatment-experienced patients with HCV GT1, 2, 4, 5, or 6 infection. Patients with HCV GT3 infection and/or liver cirrhosis were excluded. Patients received AL-335 800 mg, odalasvir 25 mg, and simeprevir 75 mg once daily for 6 or 8 weeks. The primary endpoint was sustained virologic response 12 weeks after the end of treatment (SVR12). In total, 365 patients (GT1a, 29.3%; GT1b, 42.5%; GT2, 12.3%; GT4, 14.2%; GT5, 1.4%; GT6, 0%) were randomized to receive 6 weeks (n = 183) or 8 weeks (n = 182) of treatment. SVR12 rates after 6 weeks (98.9%) or 8 weeks (97.8%) of treatment were noninferior to a historical control (98%). Viral relapse occurred in 5 patients (1.4%; 4 with HCV GT2c; 1 with GT1a). With the exception of 4 patients in the 8-week group, including 3 patients with missing data at the SVR24 timepoint, all patients who achieved SVR12 also achieved SVR24. One GT1a-infected patient experienced late viral relapse after achieving SVR18. Most adverse events (AEs) were mild with no treatment-related serious AEs. All randomized patients completed treatment. Conclusion: In HCV-infected patients, 6 and 8 weeks of treatment with JNJ-4178 resulted in SVR12 rates of 98.9% and 97.8%, respectively, and was well tolerated.",2019,Viral relapse occurred in 5 patients (1.4%; 4 with HCV GT2c; 1 with GT1a).,"['Patients with HCV GT3 infection and/or liver cirrhosis', 'chronic hepatitis C virus (HCV) genotype (GT)-1-infected patients without cirrhosis', 'experienced patients with HCV GT1, 2, 4, 5, or 6 infection']","['JNJ-4178', 'interferon (±ribavirin) treatment', 'AL-335 800 mg, odalasvir 25 mg, and simeprevir 75\xa0mg once daily for 6 or 8 weeks']","['late viral relapse', 'tolerated', 'SVR12 also achieved SVR24', 'Viral relapse', 'JNJ-4178 (AL-335, Odalasvir, and Simeprevir', 'sustained virologic response', 'SVR12 rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0023890', 'cui_str': 'Hepatic Cirrhosis'}, {'cui': 'C3805156', 'cui_str': 'Chronic hepatitis C virus genotype 1'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}]","[{'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C2605855', 'cui_str': 'simeprevir'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C2605855', 'cui_str': 'simeprevir'}, {'cui': 'C0205466', 'cui_str': 'virology'}]",365.0,0.0237121,Viral relapse occurred in 5 patients (1.4%; 4 with HCV GT2c; 1 with GT1a).,"[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Zeuzem', 'Affiliation': 'Department of Medicine, J.W. Goethe University Hospital, Frankfurt am Main, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Bourgeois', 'Affiliation': 'Department of Gastroenterology and Hepatology, ZNA Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Greenbloom', 'Affiliation': 'Toronto Digestive Disease Associates, Inc., Vaughan, ON, Canada.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Buti', 'Affiliation': ""Hospital Vall d'Hebron and Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas (CIBERehd), Barcelona, Spain.""}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Aghemo', 'Affiliation': 'Humanitas University and Research Hospital, Rozzano, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Lampertico', 'Affiliation': 'CRC ""AM e A Migliavacca,"" Division of Gastroenterology and Hepatology, Fondazione IRCCS Ca\' Granda Ospedale Maggiore Policlinico, Università di Milano, Milan, Italy.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Janczewska', 'Affiliation': 'Outpatients Clinic for Hepatology, ID Clinic, Myslowice, Poland.'}, {'ForeName': 'Seng Gee', 'Initials': 'SG', 'LastName': 'Lim', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Yong Loo Lin School of Medicine, National University Health System, Singapore.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Moreno', 'Affiliation': 'CUB Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Buggisch', 'Affiliation': 'Institute for Interdisciplinary Medicine, Hamburg, Germany.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Tam', 'Affiliation': 'LAIR Centre, Vancouver, BC, Canada.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Corbett', 'Affiliation': 'Janssen Research & Development, Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Willems', 'Affiliation': 'Janssen Research & Development, Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Leen', 'Initials': 'L', 'LastName': 'Vijgen', 'Affiliation': 'Janssen Research & Development, Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Fevery', 'Affiliation': 'Janssen Research & Development, Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Sivi', 'Initials': 'S', 'LastName': 'Ouwerkerk-Mahadevan', 'Affiliation': 'Janssen Research & Development, Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Ackaert', 'Affiliation': 'Janssen Research & Development, Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Beumont', 'Affiliation': 'Janssen Research & Development, Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Kalmeijer', 'Affiliation': 'Janssen Research & Development, LLC, Titusville, NJ.'}, {'ForeName': 'Rekha', 'Initials': 'R', 'LastName': 'Sinha', 'Affiliation': 'Janssen Research & Development, LLC, Titusville, NJ.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Biermer', 'Affiliation': 'Janssen Research & Development, Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30527']
1246,31122494,"Dual antiplatelet therapy using cilostazol for secondary prevention in patients with high-risk ischaemic stroke in Japan: a multicentre, open-label, randomised controlled trial.","BACKGROUND


Although dual antiplatelet therapy with aspirin and clopidogrel reduces early recurrence of ischaemic stroke, with long-term use this type of therapy is no longer effective and the risk of bleeding increases. Given that cilostazol prevents stroke recurrence without increasing the incidence of serious bleeding compared with aspirin, we aimed to establish whether dual antiplatelet therapy involving cilostazol is safe and appropriate for long-term use.
METHODS


In a multicentre, open-label, randomised controlled trial across 292 hospitals in Japan, patients with high-risk non-cardioembolic ischaemic stroke identified on MRI were randomly assigned to two groups in a 1:1 ratio to receive monotherapy with either oral aspirin (81 or 100 mg, once per day) or clopidogrel (50 or 75 mg, once per day) alone, or a combination of cilostazol (100 mg, twice per day) with aspirin or clopidogrel. Randomisation was done centrally (using block randomisation with a block size of six per each participating hospital) through a web-based registration system and was done by EPS Corporation. The patients were required to have at least 50% stenosis of a major intracranial or extracranial artery or two or more of the vascular risk factors. Trial medication was continued for half a year or longer, for a maximum of 3·5 years. The primary efficacy outcome was the rate of first recurrence of symptomatic ischaemic stroke. Safety outcomes were severe or life-threatening bleeding; any adverse events; serious adverse events; and any bleeding events. Efficacy analyses were done in the intention-to-treat population and safety analyses were done in the as-treated population. This trial was registered with ClinicalTrials.gov (number NCT01995370) and UMIN Clinical Trials Registry (number 000012180).
FINDINGS


Participants were recruited from Dec 13, 2013, to March 31, 2017. 932 patients assigned to the dual therapy group and 947 patients assigned to the monotherapy group were included in the intention-to-treat analysis. The trial was stopped after the enrolment of 1884 patients of an anticipated 4000 patients because of the delay in recruitment. Ischaemic stroke recurred in 29 (3%) of 932 patients (annualised rate 2·2%) on dual therapy including cilostazol and 64 (7%) of 947 patients (annualised rate 4·5%) on monotherapy during a median 1·4 years follow-up (hazard ratio [HR] 0·49, 95% CI 0·31-0·76, p=0·0010). Severe or life-threatening bleeding occurred in eight patients (annualised rate 0·6%) on dual therapy and 13 patients (annualised rate 0·9%) on monotherapy (HR 0·66, 95% CI 0·27-1·60, p=0·35). Occurrence of any type of adverse event was similar between the groups (255 [28%] of 910 patients in the dual therapy group vs 219 [24%] of 921 patients in the monotherapy group); as was occurrence of serious adverse events (87 [10%] vs 142 [15%]) and bleeding events (38 [4%] vs 33 [4%]). Gastrointestinal bleeding, which affected nine (<1%) of 910 patients in the monotherapy group and nine (<1%) of 921 patients in the dual therapy group, was the most common type of bleeding.
INTERPRETATION


The combination of cilostazol with aspirin or clopidogrel had a reduced incidence of ischaemic stroke recurrence and a similar risk of severe or life-threatening bleeding compared with treatment with aspirin or clopidogrel alone in patients at high risk for recurrent ischaemic stroke.
FUNDING


Otsuka Pharmaceutical.",2019,Ischaemic stroke recurred in 29 (3%) of 932 patients (annualised rate 2·2%) on dual therapy including cilostazol and 64 (7%) of 947 patients (annualised rate 4·5%) on monotherapy during a median 1·4 years follow-up (hazard ratio [HR],"['932 patients assigned to the dual therapy group and 947 patients assigned to the', 'patients were required to have at least 50% stenosis of a major intracranial or extracranial artery or two or more of the vascular risk factors', '292 hospitals in Japan, patients with high-risk non-cardioembolic ischaemic stroke identified on MRI', '1884 patients of an anticipated 4000 patients because of the delay in recruitment', 'patients with high-risk ischaemic stroke in Japan', 'Participants were recruited from Dec 13, 2013, to March 31, 2017']","['cilostazol with aspirin or clopidogrel', 'clopidogrel', 'aspirin', 'aspirin or clopidogrel', 'cilostazol', 'monotherapy with either oral aspirin', 'monotherapy', 'aspirin and clopidogrel', 'Dual antiplatelet therapy using cilostazol']","['Gastrointestinal bleeding', 'severe or life-threatening bleeding', 'stroke recurrence', 'Ischaemic stroke', 'Occurrence of any type of adverse event', 'bleeding', 'ischaemic stroke recurrence', 'rate of first recurrence of symptomatic ischaemic stroke', 'bleeding events', 'Severe or life-threatening bleeding', 'severe or life-threatening bleeding; any adverse events; serious adverse events; and any bleeding events', 'occurrence of serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C0580586', 'cui_str': 'Extracranial (qualifier value)'}, {'cui': 'C0003842', 'cui_str': 'Arteries'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C3842327', 'cui_str': '4000 (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}]","[{'cui': 'C0055729', 'cui_str': 'cilostazol'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]","[{'cui': 'C0017181', 'cui_str': 'Gastrointestinal Hemorrhage'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",,0.209276,Ischaemic stroke recurred in 29 (3%) of 932 patients (annualised rate 2·2%) on dual therapy including cilostazol and 64 (7%) of 947 patients (annualised rate 4·5%) on monotherapy during a median 1·4 years follow-up (hazard ratio [HR],"[{'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Toyoda', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Centre, Osaka, Japan. Electronic address: totyoda@ncvc.go.jp.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Uchiyama', 'Affiliation': 'Clinical Research Centre for Medicine, International University of Health and Welfare, Tokyo, Japan; Centre for Brain and Cerebral Vessels, Sanno Hospital and Sanno Medical Centre, Tokyo, Japan.'}, {'ForeName': 'Takenori', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Centre, Osaka, Japan.'}, {'ForeName': 'J Donald', 'Initials': 'JD', 'LastName': 'Easton', 'Affiliation': 'Department of Neurology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Kazumi', 'Initials': 'K', 'LastName': 'Kimura', 'Affiliation': 'Department of Neurological Science, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Hoshino', 'Affiliation': 'Department of Neurology, Tokyo Saiseikai Central Hospital, Tokyo, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Sakai', 'Affiliation': 'Department of Neurosurgery, Kobe City Medical Centre General Hospital, Kobe, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Okada', 'Affiliation': 'Clinical Research Institute and Department of Cerebrovascular Medicine and Neurology, National Hospital Organisation Kyushu Medical Centre, Fukuoka, Japan.'}, {'ForeName': 'Kortaro', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Department of Neurology, University of Toyama, Toyama, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Origasa', 'Affiliation': 'Division of Biostatistics and Clinical Epidemiology, University of Toyama, Toyama, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Naritomi', 'Affiliation': 'Department of Neurology, Senri Chuo Hospital, Toyonaka, Japan.'}, {'ForeName': 'Kiyohiro', 'Initials': 'K', 'LastName': 'Houkin', 'Affiliation': 'Department of Neurosurgery, Hokkaido University Graduate School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Neurology, Ichinomiya Nishi Hospital, Ichinomiya, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Isobe', 'Affiliation': 'Department of Neurosurgery, Kushiro Rosai Hospital, Kushiro, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Minematsu', 'Affiliation': 'Headquarters of the Iseikai Medical Corporation, Osaka, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30148-6']
1247,31749412,Myocardial protection technique structured on cardiac mass.,"OBJECTIVE


Myocardial protection is crucial in cardiac surgery: quantification is often difficult as there is a significant mismatch between body weight and heart weight as per geometric remodeling. This study has the objective to compare two groups of patients on the administration of myocardial protection in valvular pathologies: the first group has indexed the administration with left ventricular mass index; the second has indexed it on the body weight or on the body surface area. The primary endpoint of double-blind case-control study is to detect the difference in incidence in terms of post-operative low cardiac output syndrome.
METHODS


A single-center double-blind case-control study in a specialized regional tertiary cardiac surgery center in Italy. Between March 2017 and September 2018, 200 adults (100 per Group A vs. Group B) were scheduled for elective procedures: Group A (50 aortic valve replacement-50 mitral valve repair in minimally invasive cardiac surgery) used blood cardioplegic solution with Saint Thomas I solution, with calculation of left ventricular mass index with echocardiographic measures (Formula Group A); Group B (50 aortic valve replacement-50 mitral valve repair in minimally invasive cardiac surgery) used blood cardioplegic solution with Saint Thomas I solution, with calculation indexed on the body surface area, Du Bois Method (Formula Group B).
RESULTS


A statistically significant difference was found for Student's t-test in patients who used myocardial indexed protection on left ventricular mass index versus control: aortic valve replacement procedures in aortic valve stenosis-ejection fraction (24 hours, p-value = 0.046), TnT (24 hours, p-value = 0.047), stroke volume shift (24 hours, p-value = 0.043), and infusion of epinephrine after cardiopulmonary bypass (p-value = 0.033); aortic valve replacement procedures in aortic valve insufficiency-ejection fraction (24 hours, p-value = 0.044), TnT (24 hours, p-value = 0.047), stroke volume shift (24 hours, p-value = 0.046), and infusion of Epinephrine after cardiopulmonary bypass (p-value = 0.029). No statistically significant differences in patients undergoing mitral valve repair surgery.
CONCLUSION


The study group in the aortic valve surgery that administered myocardial protection indexed for the left ventricular mass index and showed a statistically significant lower incidence for post-operative low cardiac output syndrome compared to the control group.",2020,"A statistically significant difference was found for Student's t-test in patients who used myocardial indexed protection on left ventricular mass index versus control: aortic valve replacement procedures in aortic valve stenosis-ejection fraction (24 hours, p-value = 0.046), TnT (24 hours, p-value = 0.047), stroke volume shift (24 hours, p-value = 0.043), and infusion of epinephrine after cardiopulmonary bypass (p-value = 0.033); aortic valve replacement procedures in aortic valve insufficiency-ejection fraction (24 hours, p-value = 0.044), TnT (24 hours, p-value = 0.047), stroke volume shift (24 hours, p-value = 0.046), and infusion of Epinephrine after cardiopulmonary bypass (p-value = 0.029).","['patients undergoing mitral valve repair surgery', 'specialized regional tertiary cardiac surgery center in Italy', 'Between March 2017 and September 2018, 200 adults (100 per Group A vs. Group B) were scheduled for']","['elective procedures: Group A (50 aortic valve replacement-50 mitral valve repair in minimally invasive cardiac surgery) used blood cardioplegic solution with Saint Thomas I solution, with calculation of left ventricular mass index with echocardiographic measures (Formula Group A); Group B (50 aortic valve', 'Epinephrine', 'epinephrine', 'replacement-50 mitral valve repair in minimally invasive cardiac surgery']","['incidence in terms of post-operative low cardiac output syndrome', 'stroke volume shift']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0396849', 'cui_str': 'Repair of mitral valve (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0747973', 'cui_str': 'Elective procedure'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve (procedure)'}, {'cui': 'C0396849', 'cui_str': 'Repair of mitral valve (procedure)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0005768'}, {'cui': 'C0007200', 'cui_str': 'Cardioplegic Solutions'}, {'cui': 'C0242823', 'cui_str': 'Saints'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0003501', 'cui_str': 'Aortic Valve'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0600177', 'cui_str': 'Low Cardiac Output Syndrome'}, {'cui': 'C0038455', 'cui_str': 'Stroke Volume'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}]",200.0,0.0343474,"A statistically significant difference was found for Student's t-test in patients who used myocardial indexed protection on left ventricular mass index versus control: aortic valve replacement procedures in aortic valve stenosis-ejection fraction (24 hours, p-value = 0.046), TnT (24 hours, p-value = 0.047), stroke volume shift (24 hours, p-value = 0.043), and infusion of epinephrine after cardiopulmonary bypass (p-value = 0.033); aortic valve replacement procedures in aortic valve insufficiency-ejection fraction (24 hours, p-value = 0.044), TnT (24 hours, p-value = 0.047), stroke volume shift (24 hours, p-value = 0.046), and infusion of Epinephrine after cardiopulmonary bypass (p-value = 0.029).","[{'ForeName': 'Ignazio', 'Initials': 'I', 'LastName': 'Condello', 'Affiliation': 'Department of Cardiovascular Surgery, Anthea Hospital, GVM Care & Research, Bari, Italy.'}, {'ForeName': 'Patrizio', 'Initials': 'P', 'LastName': 'Lancellotti', 'Affiliation': 'Department of Cardiology, University of Liège, Heart Valve Clinic, CHU Sart Tilman, Liège, Belgium.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Speziale', 'Affiliation': 'Department of Cardiovascular Surgery, Anthea Hospital, GVM Care & Research, Bari, Italy.'}]",Perfusion,['10.1177/0267659119886717']
1248,31120480,The Search for and Conduct of the Elusive Phase 3 Randomized Clinical Trial: Snipe Hunting With the Military.,,2019,,[],[],[],[],[],[],,0.0793877,,"[{'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Formby', 'Affiliation': 'Department of Communicative Disorders, University of Alabama, Tuscaloosa.'}, {'ForeName': 'Roberta W', 'Initials': 'RW', 'LastName': 'Scherer', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}]",JAMA otolaryngology-- head & neck surgery,['10.1001/jamaoto.2019.0830']
1249,31136042,Safety and effectiveness of stoss therapy in children with vitamin D deficiency.,"AIM


Paediatric vitamin D (25-hydroxyvitamin D (25OHD)) deficiency can lead to nutritional rickets and extra-skeletal complications. Compliance with daily therapy can be difficult, making high-dose, short-term vitamin D (stoss) therapy attractive to correct vitamin D deficiency. We compared the effectiveness and safety of standard versus stoss therapy in treating childhood 25OHD deficiency.
METHODS


Children aged 2-16 years with 25OHD <50 nmol/L were randomised to either standard (5000 IU daily for 80 days) or stoss (100 000 IU weekly for 4 weeks) cholecalciferol. Participants underwent an evaluation of effectiveness and safety. The 25OHD level, random spot calcium: creatinine ratio (Ca:Cr) and compliance were measured at 12 weeks.
RESULTS


A total of 151 children were enrolled in the study (68 standard and 83 stoss), median age 9 years (inter-quartile range (IQR): 6-12 years). Baseline 25OHD levels were 26 nmol/L (IQR: 19-35 nmol/L) and 32 nmol/L (IQR: 24-39 nmol/L) in the standard and stoss groups, respectively. At 12 weeks, the median 25OHD level was significantly greater in the standard versus stoss group (81 vs. 67 nmol/L; P = 0.005); however, >80% of participants in both groups achieved sufficiency (25OHD > 50 nmol/L) and had normal urinary Ca:Cr, with no significant difference seen between groups. Compliance was similar in the two groups.
CONCLUSIONS


Compared to stoss, standard therapy achieved higher 25OHD levels at 12 weeks; however, in both groups, there was a similar proportion of participants who achieved 25OHD sufficiency, with no evidence of toxicity. Unlike other studies, simplifying the treatment regimen did not improve compliance. These results support stoss therapy as an effective and safe alternative therapy for the treatment of paediatric vitamin D deficiency.",2020,"Compared to stoss, standard therapy achieved higher 25OHD levels at 12 weeks; however, in both groups, there was a similar proportion of participants who achieved 25OHD sufficiency, with no evidence of toxicity.","['children with vitamin D deficiency', '151 children were enrolled in the study (68 standard and 83 stoss), median age 9 years (inter-quartile range (IQR): 6-12\u2009years', 'Children aged 2-16\u2009years with 25OHD <50\u2009nmol/L']","['stoss therapy', 'Paediatric vitamin D (25-hydroxyvitamin D (25OHD)) deficiency', 'cholecalciferol', 'standard versus stoss therapy']","['Compliance', '25OHD level, random spot calcium: creatinine ratio (Ca:Cr) and compliance', 'toxicity', 'effectiveness and safety', 'Baseline 25OHD levels', 'Safety and effectiveness', 'higher 25OHD levels', 'median 25OHD level']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439282', 'cui_str': 'nM'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0242215', 'cui_str': 'Cholecalciferols'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",151.0,0.0886774,"Compared to stoss, standard therapy achieved higher 25OHD levels at 12 weeks; however, in both groups, there was a similar proportion of participants who achieved 25OHD sufficiency, with no evidence of toxicity.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Tannous', 'Affiliation': ""Department of General Paediatrics, Sydney Children's Hospitals Network, Sydney, New South Wales, Australia.""}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Fiscaletti', 'Affiliation': ""Institute of Endocrinology and Diabetes, The Children's Hospital at Westmead, Sydney Children's Hospitals Network, Sydney, New South Wales, Australia.""}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Wood', 'Affiliation': ""Department of Immunisation Research, The Children's Hospital at Westmead, Sydney Children's Hospitals Network, Sydney, New South Wales, Australia.""}, {'ForeName': 'Hasantha', 'Initials': 'H', 'LastName': 'Gunasekera', 'Affiliation': ""Children's Hospital Westmead Clinical School, University of Sydney, Sydney, New South Wales, Australia.""}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Zurynski', 'Affiliation': 'Health Systems Sustainability, Australian Institute of Health Innovation, Macquarie University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Biggin', 'Affiliation': ""Institute of Endocrinology and Diabetes, The Children's Hospital at Westmead, Children's Hospital Westmead Clinical School, University of Sydney, Sydney, New South Wales, Australia.""}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Kilo', 'Affiliation': ""Department of Haematology, The Children's Hospital at Westmead, Sydney, New South Wales, Australia.""}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Hayes', 'Affiliation': 'Scientific Advisory Board, FIT-BIOCeuticals, Sydney, New South Wales, Australia.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Munns', 'Affiliation': ""Institute of Endocrinology and Diabetes, The Children's Hospital at Westmead, Children's Hospital Westmead Clinical School, University of Sydney, Sydney, New South Wales, Australia.""}]",Journal of paediatrics and child health,['10.1111/jpc.14497']
1250,31120533,Effect of Tinnitus Retraining Therapy vs Standard of Care on Tinnitus-Related Quality of Life: A Randomized Clinical Trial.,"Importance


Tinnitus retraining therapy (TRT) is an internationally recognized, but controversial, protocol of uncertain efficacy that uses tinnitus-specific educational counseling (TC) and sound therapy (ST) to reduce the patient's tinnitus-evoked negative reaction to, and awareness of, tinnitus.
Objective


To compare the efficacy of TRT and its components, ST and TC, with the standard of care (SoC) in reducing the negative effect of tinnitus on quality of life.
Design, Setting, and Participants


A randomized, placebo-controlled, multicenter phase 3 trial was conducted from August 4, 2011, to June 20, 2017, at 6 US military hospitals, the study chairs' office, and a data coordinating center, among 151 active-duty and retired military personnel and dependents with functionally adequate hearing sensitivity and moderate to severe subjective tinnitus. All analyses were based on intention to treat.
Interventions


Central randomized allocation to TRT (TC and ST with conventional sound generators), partial TRT (TC with placebo sound generators), or SoC.
Main Outcomes and Measures


The primary outcome was mean change on the Tinnitus Questionnaire (TQ), assessed longitudinally between baseline and 18 months after start of therapy. The secondary outcomes were changes in TQ subscales, Tinnitus Functional Index (TFI), and Tinnitus Handicap Inventory (THI) total and subscales, as well as a 10-point visual analog scale (VAS).
Results


Among the 151 participants in the study (44 women and 107 men; mean [SD] age, 50.6 [11.3] years), 51 were randomized to receive TRT, 51 to receive partial TRT, and 49 to receive standard of care. Longitudinal analyses showed no difference between partial TRT or TRT compared with SoC, or partial TRT compared with TRT, on TQ, TFI, or THI total scores. Comparison of changes in mean score from baseline to the 18-month visit also showed no difference between treatment groups. Significant improvement was observed at 18 months in all treatment groups on TQ scores for TRT (effect size, -1.32; 95% CI, -1.78 to -0.85), partial TRT (effect size, -1.16; 95% CI, -1.56 to -0.76), and SoC (effect size, -1.01; 95% CI, -1.41 to -0.61). Compared with baseline scores, at 18 months there were reductions in scores by 7 points or more on the TQ score for 86 of 111 participants (77.55%; 95% CI, 69.7%-85.2%), 13 points or more on the TFI for 52 of 111 participants (46.8%; 95% CI, 37.6%-56.1%), 7 points or more on the THI for 63 of 111 participants (56.8%; 95% CI, 47.5%-66.0%), and 2 points or more on the VAS for 45 of 93 participants (48.4%; 95% CI, 38.2%-58.5%).
Conclusions and Relevance


There were few differences between treatment groups. About half of participants showed clinically meaningful reductions in the effect of tinnitus.
Trial Registration


ClinicalTrials.gov identifier: NCT01177137.",2019,"Significant improvement was observed at 18 months in all treatment groups on TQ scores for TRT (effect size, -1.32; 95% CI, -1.78 to -0.85), partial TRT (effect size, -1.16; 95% CI, -1.56 to -0.76), and SoC (effect size, -1.01; 95% CI, -1.41 to -0.61).","['151 participants in the study (44 women and 107 men; mean [SD] age, 50.6 [11.3] years', ""August 4, 2011, to June 20, 2017, at 6 US military hospitals, the study chairs' office, and a data coordinating center, among 151 active-duty and retired military personnel and dependents with functionally adequate hearing sensitivity and moderate to severe subjective tinnitus""]","['Tinnitus Retraining Therapy vs Standard of Care', 'TRT', 'placebo', 'tinnitus-specific educational counseling (TC) and sound therapy (ST', 'TRT (TC and ST with conventional sound generators), partial TRT (TC with placebo sound generators), or SoC.\nMain Outcomes and Measures', 'Tinnitus retraining therapy (TRT', 'partial TRT']","['TQ score', 'TQ scores', 'mean change on the Tinnitus Questionnaire (TQ', 'changes in TQ subscales, Tinnitus Functional Index (TFI), and Tinnitus Handicap Inventory (THI) total and subscales, as well as a 10-point visual analog scale (VAS', 'TQ, TFI, or THI total scores', 'quality of life', 'Tinnitus-Related Quality of Life', 'partial TRT']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0020012', 'cui_str': 'Military Hospitals'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0035345', 'cui_str': 'Retirement'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}]","[{'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0237638', 'cui_str': 'Generator'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0034380'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}]",44.0,0.343141,"Significant improvement was observed at 18 months in all treatment groups on TQ scores for TRT (effect size, -1.32; 95% CI, -1.78 to -0.85), partial TRT (effect size, -1.16; 95% CI, -1.56 to -0.76), and SoC (effect size, -1.01; 95% CI, -1.41 to -0.61).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Roberta W', 'Initials': 'RW', 'LastName': 'Scherer', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Formby', 'Affiliation': 'Department of Communicative Disorders, University of Alabama, Tuscaloosa.'}]",JAMA otolaryngology-- head & neck surgery,['10.1001/jamaoto.2019.0821']
1251,30478008,Herpes simplex virus 1 infection and valacyclovir treatment in schizophrenia: Results from the VISTA study.,"BACKGROUND


Several studies have implicated herpes simplex virus-type 1 (HSV-1) in the pathophysiology of schizophrenia. A recent trial demonstrated that the anti-viral medication valacylovir, which prevents replication of activated HSV-1, improved selected cognitive deficits in people with schizophrenia. In this study, we examined demographic and illness related differences between HSV-1 positive versus HSV-1 negative subjects with early phase schizophrenia and attempted to replicate the previous valacyclovir treatment results in this population.
METHODS


170 subjects with schizophrenia (HSV-1 positive N = 70; HSV-1 negative N = 96) from 12 US sites participated in the HSV-1 positive versus negative comparisons, and were randomized 1:1 to valacyclovir (1.5 g BID) or placebo for a 16-week, double-blind efficacy trial. The primary endpoints were working and verbal memory.
RESULTS


The HSV-1 positive group, as compared to the HSV-1 negative group, were older (p < 0.001) with fewer males (p = 0.003), and had a longer duration of illness (p = 0.008), more positive symptoms (p = 0.013), poorer quality of life (p = 0.034) and more impairment on the letter-number sequencing test, which is a measure of working memory (p = 0.045). Valacyclovir failed to significantly improve any of the cognitive indices, symptom or functioning measures.
CONCLUSIONS


HSV-1 sero-positivity appears to be a marker of a subgroup with a more severe form of schizophrenia. Valacyclovir was not efficacious in the study, perhaps because the herpes virus was in the dormant, non-activated state and therefore non-responsive to valacyclovir effects. ClinicalTrials.gov Identifier: NCT02008773.",2019,"Valacyclovir failed to significantly improve any of the cognitive indices, symptom or functioning measures.
","['people with schizophrenia', 'schizophrenia', '170 subjects with schizophrenia (HSV-1 positive N\u202f=\u202f70; HSV-1 negative N\u202f=\u202f96) from 12 US sites participated in the HSV-1 positive versus negative comparisons']","['valacyclovir', 'placebo', 'Valacyclovir']","['longer duration of illness', 'poorer quality of life', 'cognitive indices, symptom or functioning measures', 'working and verbal memory', 'positive symptoms']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0206679', 'cui_str': 'Human herpesvirus 1'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0249458', 'cui_str': 'valacyclovir'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439591', 'cui_str': 'Long duration (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0034380'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",170.0,0.23529,"Valacyclovir failed to significantly improve any of the cognitive indices, symptom or functioning measures.
","[{'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Breier', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, United States of America. Electronic address: abreier@iupui.edu.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Buchanan', 'Affiliation': 'Maryland Psychiatric Research Center, University of Maryland, Baltimore, MD, United States of America.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': ""D'Souza"", 'Affiliation': 'Yale University School of Medicine, New Haven, CT, United States of America.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Nuechterlein', 'Affiliation': 'Semel Institute, UCLA, Los Angeles, CA, United States of America.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Marder', 'Affiliation': 'Semel Institute, UCLA, Los Angeles, CA, United States of America.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Dunn', 'Affiliation': 'Semel Institute, UCLA, Los Angeles, CA, United States of America.'}, {'ForeName': 'Sheldon', 'Initials': 'S', 'LastName': 'Preskorn', 'Affiliation': 'Kansas University School of Medicine, Wichita, KS, United States of America.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Macaluso', 'Affiliation': 'Kansas University School of Medicine, Wichita, KS, United States of America.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Wurfel', 'Affiliation': 'Laureate Institute for Brain Research, KS, United States of America.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Maguire', 'Affiliation': 'University of California, Riverside, CA, United States of America.'}, {'ForeName': 'Rishi', 'Initials': 'R', 'LastName': 'Kakar', 'Affiliation': 'Segal Institute for Clinical Research, United States of America.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Highum', 'Affiliation': 'CITrials, Bellflower, CA, United States of America.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Hoffmeyer', 'Affiliation': 'CITrials, Bellflower, CA, United States of America.'}, {'ForeName': 'Evagelos', 'Initials': 'E', 'LastName': 'Coskinas', 'Affiliation': 'CITrials, Santa Ana, CA, United States of America.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Litman', 'Affiliation': 'CBH Health, Rockville, MD, United States of America.'}, {'ForeName': 'Jenifer L', 'Initials': 'JL', 'LastName': 'Vohs', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, United States of America.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Radnovich', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, United States of America.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Francis', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, United States of America.'}, {'ForeName': 'Emmalee', 'Initials': 'E', 'LastName': 'Metzler', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, United States of America.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Visco', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, United States of America.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Mehdiyoun', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, United States of America.'}, {'ForeName': 'Ziyi', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, United States of America.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, United States of America.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Yolken', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, United States of America.'}, {'ForeName': 'Faith B', 'Initials': 'FB', 'LastName': 'Dickerson', 'Affiliation': 'Sheppard Pratt Health System, Baltimore, MD, United States of America.'}]",Schizophrenia research,['10.1016/j.schres.2018.11.002']
1252,31106977,Vertebroplasty for acute painful osteoporotic vertebral compression fractures: An update.,"Vertebral compression fractures (VCFs) are a common cause of back pain and disability and are usually osteoporotic in nature. Therapy aims to adequately control pain and allow early mobilisation and return of function while preventing additional fractures. A proportion of patients do not achieve adequate pain relief using conservative measures alone. Unwanted adverse effects from medications may also ensue. Vertebroplasty represents an alternative treatment option for VCFs. Patients with acute VCFs (≤6 weeks old) may gain the most benefit from vertebroplasty as healed fractures are not as amenable to cement injection. High-quality studies have reported conflicting results regarding the use of vertebroplasty in the treatment of acute VCFs. Despite high-quality evidence, varying study designs and heterogenous patient cohorts make interpretation of this data difficult. Only one sham-controlled randomised controlled trial (RCT) has evaluated vertebroplasty exclusively in patients with acute VCFs, reporting favourable results. Pooled data from RCTs also suggest vertebroplasty to be safe. This article provides a concise and critical review of the current literature regarding vertebroplasty for the treatment of acute VCFs.",2019,Patients with acute VCFs (≤6 weeks old) may gain the most benefit from vertebroplasty as healed fractures are not as amenable to cement injection.,"['acute painful osteoporotic vertebral compression fractures', 'patients with acute VCFs', 'Patients with acute VCFs (≤6\xa0weeks old']","['Vertebral compression fractures (VCFs', 'Vertebroplasty']",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521169', 'cui_str': 'Compression fracture (morphologic abnormality)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0521169', 'cui_str': 'Compression fracture (morphologic abnormality)'}, {'cui': 'C1303192', 'cui_str': 'Vertebroplasty'}]",[],,0.0386381,Patients with acute VCFs (≤6 weeks old) may gain the most benefit from vertebroplasty as healed fractures are not as amenable to cement injection.,"[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Lamanna', 'Affiliation': 'Interventional Radiology Service - Department of Radiology, Austin Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Maingard', 'Affiliation': 'Department of Imaging, Monash Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Hong Kuan', 'Initials': 'HK', 'LastName': 'Kok', 'Affiliation': 'Interventional Radiology Service, Northern Hospital Radiology, Melbourne, Victoria, Australia.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Ranatunga', 'Affiliation': 'Interventional Radiology Service - Department of Radiology, Austin Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Seamus T', 'Initials': 'ST', 'LastName': 'Looby', 'Affiliation': 'Interventional Radiology Service - Department of Radiology, Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Brennan', 'Affiliation': 'Interventional Radiology Service - Department of Radiology, Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Chua', 'Affiliation': 'Department of Imaging, Monash Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Owen', 'Affiliation': 'Interventional Radiology Service - Department of Radiology, Austin Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Duncan Mark', 'Initials': 'DM', 'LastName': 'Brooks', 'Affiliation': 'Interventional Radiology Service - Department of Radiology, Austin Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ronil V', 'Initials': 'RV', 'LastName': 'Chandra', 'Affiliation': 'Department of Imaging, Monash Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Asadi', 'Affiliation': 'Interventional Radiology Service - Department of Radiology, Austin Hospital, Melbourne, Victoria, Australia.'}]",Journal of medical imaging and radiation oncology,['10.1111/1754-9485.12900']
1253,31113214,Cluster Randomized Controlled Trial of Disability Education Module During Clinical Clerkship.,"The effect of a randomized disability education program on medical student knowledge and attitudes concerning disability was performed. Intervention group received bedside teaching of physical examination/interview skills and case-based discussion. Twenty-three participants completed the study (control group n = 11; intervention group n = 12). Pre-clerkship, 39% of all participants reported no personal experience and 43% reported no professional experience with people with disabilities. Post-clerkship knowledge was higher for both groups; the test of group-by-time interaction was not significant. Qualitative analysis of post-clerkship attitude responses demonstrated that intervention group gave more detailed answers. Intervention group used terms representing functional aspects of disability twice as frequently as control group. Intervention group responses described long-term experience of a disability within community and family; control group responses focused on acute medical management. Participation in disability education resulted in changed attitude toward disability and better understanding of aspects of disability.",2019,Post-clerkship knowledge was higher for both groups; the test of group-by-time interaction was not significant.,['Twenty-three participants completed the study (control group n = 11; intervention group n = 12'],"['Disability Education Module', 'Intervention group responses described long-term experience of a disability within community and family; control group responses focused on acute medical management', 'randomized disability education program', 'bedside teaching of physical examination/interview skills and case-based discussion']",['medical student knowledge and attitudes concerning disability'],"[{'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441848', 'cui_str': 'Group N (qualifier value)'}]","[{'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}]","[{'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",23.0,0.029739,Post-clerkship knowledge was higher for both groups; the test of group-by-time interaction was not significant.,"[{'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Santoro', 'Affiliation': 'Massachusetts General Hospital, Boston MA, USA.'}, {'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Whitgob', 'Affiliation': 'Santa Clara Valley Medical Center, San Jose, CA, USA.'}, {'ForeName': 'Lynne C', 'Initials': 'LC', 'LastName': 'Huffman', 'Affiliation': ""Lucile Packard Children's Hospital, Palo Alto, CA, USA.""}]",Clinical pediatrics,['10.1177/0009922819850475']
1254,30232597,The role of small intestinal bacterial overgrowth in cystic fibrosis: a randomized case-controlled clinical trial with rifaximin.,"BACKGROUND


Scientific literature shows a high prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in patients with Cystic Fibrosis (CF). The role of SIBO in nutritional status and gastrointestinal symptoms in CF is not known. Our aim was to study epidemiology and clinical impact of SIBO while assessing the efficacy of rifaximin in eradicating SIBO in CF patients.
METHODS


Symptoms questionnaire and Glucose Breath Test (GBT) were given to 79 CF patients (median age 19.6 years; 9.2-36.9). Subjects with a positive GBT were enrolled in a randomized controlled trial and received rifaximin 1200 mg for 14 days or no treatment. Questionnaire and GBT were repeated 1 month after the end of treatment or 45 days after the first negative GBT.
RESULTS


Out of 79 patients, 25 were affected by SIBO (31.6%) with a significant correlation with lower BMI, SDS-BMI (p < 0.05) and serum albumin levels (p < 0.05), independently from pancreas insufficiency. Twenty-three patients took part in the randomized trial, 13 patients (56.5%) in rifaximin group and 10 patients (43.5%) in control group. Eradication rate of SIBO was 9/10 (90%) in rifaximin group and 2/6 (33.3%) in control group (p < 0.05). In the rifaximin group, gastrointestinal symptom improvement was observed in 4/5 patients aged ≤ 14 years and in 0/5 patients aged > 14 years (p < 0.05); in 2/6 patients in the control group.
CONCLUSIONS


CF patients show a high prevalence of SIBO, related to a poorer nutritional status. Rifaximin therapy is well tolerated and the results are promising in terms of efficacy in eradicating small intestinal bacterial overgrowth in CF.",2019,Rifaximin therapy is well tolerated and the results are promising in terms of efficacy in eradicating small intestinal bacterial overgrowth in CF.,"['79 patients', 'Subjects with a positive GBT', 'CF patients', '79 CF patients (median age 19.6\xa0years; 9.2-36.9', 'patients with Cystic Fibrosis (CF', 'cystic fibrosis']","['Rifaximin therapy', 'rifaximin', 'rifaximin 1200\xa0mg for 14\xa0days or no treatment']","['serum albumin levels', 'Symptoms questionnaire and Glucose Breath Test (GBT', 'Eradication rate of SIBO', 'Questionnaire and GBT', 'lower BMI, SDS-BMI', 'gastrointestinal symptom improvement']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}]","[{'cui': 'C0073374', 'cui_str': 'rifaximin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum (procedure)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0006153', 'cui_str': 'Breath Tests'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}]",13.0,0.0467651,Rifaximin therapy is well tolerated and the results are promising in terms of efficacy in eradicating small intestinal bacterial overgrowth in CF.,"[{'ForeName': 'Manuele', 'Initials': 'M', 'LastName': 'Furnari', 'Affiliation': 'Department of Internal Medicine, Gastroenterology Unit, Policlinico ""San Martino"", University of Genoa, Viale Benedetto XV, 6, 16132, Genoa, Italy. manuelefurnari@gmail.com.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'De Alessandri', 'Affiliation': 'Cystic Fibrosis Center, IRCCS G. Gaslini Institute, Genoa, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Cresta', 'Affiliation': 'Cystic Fibrosis Center, IRCCS G. Gaslini Institute, Genoa, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Haupt', 'Affiliation': 'Cystic Fibrosis Center, IRCCS G. Gaslini Institute, Genoa, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Bassi', 'Affiliation': 'Cystic Fibrosis Center, IRCCS G. Gaslini Institute, Genoa, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Calvi', 'Affiliation': 'Gastroenterology and Pediatric Endoscopy Unit, IRCCS G. Gaslini Institute, Genoa, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Haupt', 'Affiliation': 'Epidemiology and Biostatistic Service, IRCCS G. Gaslini Institute, Genoa, Italy.'}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Bodini', 'Affiliation': 'Department of Internal Medicine, Gastroenterology Unit, Policlinico ""San Martino"", University of Genoa, Viale Benedetto XV, 6, 16132, Genoa, Italy.'}, {'ForeName': 'Iftikhar', 'Initials': 'I', 'LastName': 'Ahmed', 'Affiliation': 'Department of Gastroenterology, Aldara Hospital and Medical Centre, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Bagnasco', 'Affiliation': 'Epidemiology and Biostatistic Service, IRCCS G. Gaslini Institute, Genoa, Italy.'}, {'ForeName': 'Edoardo Giovanni', 'Initials': 'EG', 'LastName': 'Giannini', 'Affiliation': 'Department of Internal Medicine, Gastroenterology Unit, Policlinico ""San Martino"", University of Genoa, Viale Benedetto XV, 6, 16132, Genoa, Italy.'}, {'ForeName': 'Rosaria', 'Initials': 'R', 'LastName': 'Casciaro', 'Affiliation': 'Cystic Fibrosis Center, IRCCS G. Gaslini Institute, Genoa, Italy.'}]",Journal of gastroenterology,['10.1007/s00535-018-1509-4']
1255,31746546,Factors affecting the outcome of the suction blisters using two different harvesting techniques in vitiligo patients.,"BACKGROUND


Suction blister grafting (SBG) technique has been used for long to treat various skin conditions. Different suction methods have been used such as syringes, Chinese cups, and suction device. There are some limitations of its use as time consumption, failure of induction or incomplete blister formation and pain.
AIM


The aim of this work was to evaluate the outcome of using two different suction techniques, namely the syringes and the Chinese cups in induction of suction blisters. The effect of the device diameter and preheating of the donor area on the suction blister induction time (SBIT) was studied. The effect of saline injection in the blister formation and its completion was also evaluated.
METHODS


The study was a left-right comparative study that included 50 patients with stable nonsegmental vitiligo. They were classified into four groups: Group 1 included 15 patients where different diameters of syringes (1.3, 1.7, and 2 cm) were compared against each other, group 2 included 15 patients where different diameters of cups (2, 3.5, and 5 cm) were compared against each other, group 3 included 20 patients subdivided into two groups; 10 patients each, where the effect of preheating the skin on blister induction was tested with use of cups (3a) and syringes (3b). Lastly, group 4 included randomly chosen 40 incomplete or multilocular blisters where the effect of saline injection on blister completion and coalescence of multilobulation was examined. SBIT was calculated in all patients.
RESULTS


The use of the small diameter syringes or cups gave shorter SBIT; however, the difference, which was significant between all sizes of cups, was significant between the 1.3- and 2-cm-diameter syringes only. Preheating of the donor area shorten SBIT significantly. No complications were reported at the donor site except for transient postinflammatory hyperpigmentation in all patients.
CONCLUSION


The small diameter syringes or cups and preheating of the donor area shorten the SBIT, while intra-blister saline injection increased the blister size and turns the multilocular blisters to unilocular ones.",2020,"No complications were reported at the donor site except for transient postinflammatory hyperpigmentation in all patients.
","['vitiligo patients', '50 patients with stable nonsegmental vitiligo']","['Suction blister grafting (SBG) technique', 'saline injection']","['SBIT', 'suction blister induction time (SBIT', 'transient postinflammatory hyperpigmentation']","[{'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}]","[{'cui': 'C0038638', 'cui_str': 'Aspiration, Mechanical'}, {'cui': 'C1319688', 'cui_str': 'Blister - unit of product usage'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0038638', 'cui_str': 'Aspiration, Mechanical'}, {'cui': 'C1319688', 'cui_str': 'Blister - unit of product usage'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0333616', 'cui_str': 'Postinflammatory hyperpigmentation (morphologic abnormality)'}]",40.0,0.0404801,"No complications were reported at the donor site except for transient postinflammatory hyperpigmentation in all patients.
","[{'ForeName': 'Tag S', 'Initials': 'TS', 'LastName': 'Anbar', 'Affiliation': ""Department of Dermatology, STD's and Andrology, Minia University, Minia, Egypt.""}, {'ForeName': 'Hasan M', 'Initials': 'HM', 'LastName': 'El-Fakahany', 'Affiliation': ""Department of Dermatology, STD's and Andrology, Minia University, Minia, Egypt.""}, {'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'El-Khayyat', 'Affiliation': ""Department of Dermatology, STD's and Andrology, Minia University, Minia, Egypt.""}, {'ForeName': 'Amal T', 'Initials': 'AT', 'LastName': 'Abdel-Rahman', 'Affiliation': ""Department of Dermatology, STD's and Andrology, Minia University, Minia, Egypt.""}, {'ForeName': 'Enas K', 'Initials': 'EK', 'LastName': 'Saad', 'Affiliation': ""Department of Dermatology, STD's and Andrology, Matay Central Hospital, Minia, Egypt.""}]",Journal of cosmetic dermatology,['10.1111/jocd.13222']
1256,30995176,"Final Results of a Randomized, Phase III Study of Rituximab With or Without Idelalisib Followed by Open-Label Idelalisib in Patients With Relapsed Chronic Lymphocytic Leukemia.","PURPOSE


A randomized, double-blind, phase III study of idelalisib (IDELA) plus rituximab versus placebo plus rituximab in patients with relapsed chronic lymphocytic leukemia (CLL) was terminated early because of superior efficacy of the IDELA-plus-rituximab (IDELA/R) arm. Patients in either arm could then enroll in an extension study to receive IDELA monotherapy. Here, we report the long-term efficacy and safety data for IDELA-treated patients across the primary and extension studies.
PATIENTS AND METHODS


Patients were randomly assigned to receive rituximab in combination with either IDELA 150 mg twice daily (IDELA/R; n = 110) or placebo (placebo/R; n = 110). Key end points were progression-free survival (PFS), overall response rate (ORR), overall survival (OS), and safety.
RESULTS


The long-term efficacy and safety of treatment with IDELA was assessed in 110 patients who received at least one dose of IDELA in the primary study, 75 of whom enrolled in the extension study. The IDELA/R-to-IDELA group had a median PFS of 20.3 months (95% CI, 17.3 to 26.3 months) after a median follow-up time of 18 months (range, 0.3 to 67.6 months). The ORR was 85.5% (94 of 110 patients; n = 1 complete response). The median OS was 40.6 months (95% CI, 28.5 to 57.3 months) and 34.6 months (95% CI, 16.0 months to not reached) for patients randomly assigned to the IDELA/R and placebo/R groups, respectively. Prolonged exposure to IDELA increased the incidence of all-grade, grade 2, and grade 3 or greater diarrhea (46.4%, 17.3%, and 16.4%, respectively), all-grade and grade 3 or greater colitis (10.9% and 8.2%, respectively) and all-grade and grade 3 or greater pneumonitis (10.0% and 6.4%, respectively) but did not increase the incidence of elevated hepatic aminotransferases.
CONCLUSION


IDELA improved PFS and OS compared with rituximab alone in patients with relapsed CLL. Long-term IDELA was effective and had an expected safety profile. No new IDELA-related adverse events were identified with longer exposure.",2019,"The median OS was 40.6 months (95% CI, 28.5 to 57.3 months) and 34.6 months (95% CI, 16.0 months to not reached) for patients randomly assigned to the IDELA/R and placebo/R groups, respectively.","['patients with relapsed chronic lymphocytic leukemia (CLL', 'Patients With Relapsed Chronic Lymphocytic Leukemia', 'Patients', '110 patients who received at least one dose of IDELA in the primary study, 75 of whom enrolled in the extension study', 'patients with relapsed CLL']","['IDELA', 'Rituximab With or Without Idelalisib', 'IDELA monotherapy', 'placebo plus rituximab', 'IDELA-plus-rituximab (IDELA/R', 'idelalisib (IDELA) plus rituximab', 'rituximab', 'rituximab in combination with either IDELA 150 mg twice daily (IDELA/R; n = 110) or placebo (placebo']","['PFS and OS', 'grade and grade 3 or greater colitis', 'pneumonitis', 'progression-free survival (PFS), overall response rate (ORR), overall survival (OS), and safety', 'diarrhea', 'median OS', 'ORR', 'median PFS', 'incidence of elevated hepatic aminotransferases']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C2698692', 'cui_str': 'idelalisib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0009319', 'cui_str': 'Colitis'}, {'cui': 'C3714636', 'cui_str': 'Pulmonary Inflammation'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}]",110.0,0.412396,"The median OS was 40.6 months (95% CI, 28.5 to 57.3 months) and 34.6 months (95% CI, 16.0 months to not reached) for patients randomly assigned to the IDELA/R and placebo/R groups, respectively.","[{'ForeName': 'Jeff P', 'Initials': 'JP', 'LastName': 'Sharman', 'Affiliation': '1 Willamette Valley Cancer Institute and Research Center, US Oncology Research, Springfield, OR.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Coutre', 'Affiliation': '2 Stanford School of Medicine, Stanford, CA.'}, {'ForeName': 'Richard R', 'Initials': 'RR', 'LastName': 'Furman', 'Affiliation': '3 Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Cheson', 'Affiliation': '4 Georgetown University Hospital, Washington DC.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Pagel', 'Affiliation': '5 Swedish Cancer Institute, Seattle, WA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillmen', 'Affiliation': ""6 St James's University Hospital, Leeds, United Kingdom.""}, {'ForeName': 'Jacqueline C', 'Initials': 'JC', 'LastName': 'Barrientos', 'Affiliation': '7 Zucher School of Medicine at Hofstra/Northwell, New Hyde Park, NY.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Zelenetz', 'Affiliation': '8 Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Kipps', 'Affiliation': '9 University of California, San Diego, Moores Cancer Center, La Jolla, CA.'}, {'ForeName': 'Ian W', 'Initials': 'IW', 'LastName': 'Flinn', 'Affiliation': '10 Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Ghia', 'Affiliation': '11 Università Vita-Salute San Raffaele and Istituto Di Ricovero e Cura a Carattere Scientifico Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Eradat', 'Affiliation': '12 David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, CA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ervin', 'Affiliation': '13 Venice Regional Bayfront Health, Venice, FL.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Lamanna', 'Affiliation': '14 Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Coiffier', 'Affiliation': '15 Centre Hospitalier Lyon-Sud, Pierre Benite, France.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Pettitt', 'Affiliation': '16 University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': '17 Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL.'}, {'ForeName': 'Eugen', 'Initials': 'E', 'LastName': 'Tausch', 'Affiliation': '18 Ulm University, Ulm, Germany.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Cramer', 'Affiliation': '19 University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': '20 Gilead Sciences, Foster City, CA.'}, {'ForeName': 'Siddhartha', 'Initials': 'S', 'LastName': 'Mitra', 'Affiliation': '20 Gilead Sciences, Foster City, CA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hallek', 'Affiliation': '19 University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': '21 University of California, Irvine, Orange, CA.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Stilgenbauer', 'Affiliation': '18 Ulm University, Ulm, Germany.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01460']
1257,31136460,STRICT POSTURING WITH OR WITHOUT BILATERAL PATCHING FOR POSTERIOR VITREOUS DETACHMENT-RELATED VITREOUS HEMORRHAGE.,"PURPOSE


To determine whether bilateral patching with posturing is superior to posturing alone in visualizing the superior retina in suspected posterior vitreous detachment (PVD)-related vitreous hemorrhage (VH).
METHODS


Prospective randomized controlled trial: 80 patients with fundus-obscuring VH due to suspected retinal tear were randomized to strict posturing and bilateral patching overnight (Treatment A, 40 patients) or posturing (Treatment B, 40 patients).
PRIMARY OUTCOME


Visualization of ≥4 clock hours superior retina.
SECONDARY OUTCOME MEASURES


laser treatment, vitrectomy rate, and retinal detachment within 12 months.
RESULTS


Intention-to-treat analysis: In 38/40 (95%) with Treatment A and 32/40 (80%) with Treatment B, the confirmed diagnosis was PVD-related VH. Visibility of the superior retina for all patients: 29/40 (73%) after Treatment A and 21/40 (53%) after Treatment B (P = 0.07). Subgroup analysis for confirmed PVD-related VH; visibility of the superior retina: 29/38 (76%) after Treatment A and 15/32 (47%) after Treatment B (P = 0.01). In subgroup analysis, vitrectomy rate within 12 months was 61% (Treatment A) and 53% (Treatment B) (P = 0.63). Retinal detachment: eight patients after each treatment.
CONCLUSION


In patients with suspected PVD-related VH, overnight bilateral patching was not superior to posturing alone in superior retina visualization, but in a post-hoc analysis of patients with confirmed PVD-related VH, bilateral patching was superior.",2020,Visibility of the superior retina for all patients: 29/40 (73%) after Treatment A and 21/40 (53%) after Treatment B (P = 0.07).,"['Retinal detachment: eight patients after each treatment', 'suspected posterior vitreous detachment (PVD)-related vitreous hemorrhage (VH', '80 patients with fundus-obscuring VH due to suspected retinal tear']",['strict posturing and bilateral patching overnight'],"['laser treatment, vitrectomy rate, and retinal detachment within 12 months', 'vitrectomy rate', 'Visualization of ≥4 clock hours superior retina', 'Visibility of the superior retina']","[{'cui': 'C0035305', 'cui_str': 'Retinal Detachment'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0423361', 'cui_str': 'Posterior Vitreous Detachment'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0042909', 'cui_str': 'Vitreous Hemorrhage'}, {'cui': 'C0227817', 'cui_str': 'Uterine Fundus'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0035321', 'cui_str': 'Retinal Dialyses'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}]","[{'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0035305', 'cui_str': 'Retinal Detachment'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0035298', 'cui_str': 'Retina'}]",80.0,0.16545,Visibility of the superior retina for all patients: 29/40 (73%) after Treatment A and 21/40 (53%) after Treatment B (P = 0.07).,"[{'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'van Etten', 'Affiliation': 'Department of Vitreoretinal Surgery, Rotterdam Eye Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Koen A', 'Initials': 'KA', 'LastName': 'van Overdam', 'Affiliation': 'Department of Vitreoretinal Surgery, Rotterdam Eye Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Reyniers', 'Affiliation': 'Department of Vitreoretinal Surgery, Rotterdam Eye Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Veckeneer', 'Affiliation': 'Department of Vitreoretinal Surgery, Rotterdam Eye Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Koorosh', 'Initials': 'K', 'LastName': 'Faridpooya', 'Affiliation': 'Department of Vitreoretinal Surgery, Rotterdam Eye Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'René J', 'Initials': 'RJ', 'LastName': 'Wubbels', 'Affiliation': 'Rotterdam Ophthalmic Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Manning', 'Affiliation': 'Department of Vitreoretinal Surgery, Rotterdam Eye Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Ellen C', 'Initials': 'EC', 'LastName': 'La Heij', 'Affiliation': 'Department of Vitreoretinal Surgery, Rotterdam Eye Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Jan C', 'Initials': 'JC', 'LastName': 'van Meurs', 'Affiliation': 'Department of Vitreoretinal Surgery, Rotterdam Eye Hospital, Rotterdam, The Netherlands.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002561']
1258,31111862,"Outcomes in Patients Treated With Thin-Strut, Very Thin-Strut, or Ultrathin-Strut Drug-Eluting Stents in Small Coronary Vessels: A Prespecified Analysis of the Randomized BIO-RESORT Trial.","Importance


Stenting small-vessel lesions has an increased adverse cardiovascular event risk. Very thin-strut or ultrathin-strut drug-eluting stents might reduce this risk, but data are scarce.
Objective


To assess the outcome of all-comer patients with small coronary vessel lesions treated with 3 dissimilar types of drug-eluting stents.
Design


This is a prespecified substudy of the Comparison of Biodegradable Polymer and Durable Polymer Drug-eluting Stents in an All Comers Population (BIO-RESORT) trial, an investigator-initiated, randomized, patient-blinded comparative clinical drug-eluting stent trial. Patients treated with ultrathin-strut sirolimus-eluting stents, very thin-strut everolimus-eluting stents, or previous-generation thin-strut zotarolimus-eluting stents were enrolled from December 2012 to August 2015. This multicenter trial was conducted in 4 Dutch centers for cardiac intervention. Of all 3514 all-comer BIO-RESORT participants, 1506 patients with treatment in at least 1 small-vessel lesion (reference vessel <2.5 mm) were included. Data were analyzed between September 2018 and February 2019.
Main Outcomes and Measures


Target lesion failure at 3-year follow-up, a composite of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization, analyzed by Kaplan-Meier methods.
Results


In 1452 of 1506 participants (96.4%) (1057 men [70.2%]; 449 women [29.8%]; mean [SD] age, 64.3 [10.4] years), follow-up was available. Target lesion failure occurred in 36 of 525 patients (7.0%) treated with sirolimus-eluting stents, 46 of 496 (9.5%) with everolimus-eluting stents, and 48 of 485 (10.0%) with zotarolimus-eluting stents (sirolimus-eluting vs zotarolimus-eluting hazard ratio [HR], 0.68; 95% CI, 0.44-1.05; P = .08; everolimus-eluting vs zotarolimus-eluting HR, 0.93; 95% CI, 0.62-1.39; P = .72). There was a difference in target lesion revascularizations between sirolimus-eluting and zotarolimus-eluting stents (2.1% vs 5.3%; HR, 0.40; 95% CI, 0.20-0.81; P = .009) that emerged after the first year of follow-up (1.0% vs 3.7%; P = .006); multivariate analysis showed that sirolimus-eluting stent implantation was independently associated with a lower target lesion revascularization rate at 3-year follow-up (adjusted HR, 0.42; 95% CI, 0.20-0.85; P = .02). In the everolimus-eluting stents, the revascularization rate was 4.0% (vs zotarolimus-eluting, HR, 0.74; 95% CI, 0.41-1.34; P = .31). There was no significant between-stent difference in cardiac death, target vessel myocardial infarction, or stent thrombosis.
Conclusions and Relevance


Patients stented in small coronary vessels experienced fewer repeated revascularizations if treated with ultrathin-strut sirolimus-eluting stents vs previous generation thin strut zotarolimus-eluting stents. Further research is required to evaluate the potential effect of particularly thin stent struts.
Trial Registration


ClinicalTrials.gov identifier: NCT01674803.",2019,"There was a difference in target lesion revascularizations between sirolimus-eluting and zotarolimus-eluting stents (2.1% vs 5.3%; HR, 0.40; 95% CI, 0.20-0.81; P = .009) that emerged after the first year of follow-up (1.0% vs 3.7%; P = .006); multivariate analysis showed that sirolimus-eluting stent implantation was independently associated with a lower target lesion revascularization rate at 3-year follow-up (adjusted HR, 0.42; 95% CI, 0.20-0.85; P = .02).","['Patients Treated With Thin-Strut, Very Thin-Strut, or Ultrathin-Strut Drug-Eluting Stents in Small Coronary Vessels', 'In 1452 of 1506 participants (96.4%) (1057 men [70.2%]; 449 women [29.8%]; mean [SD] age, 64.3 [10.4] years), follow-up was available', '1506 patients with treatment in at least 1 small-vessel lesion (reference vessel <2.5 mm) were included', '4 Dutch centers for cardiac intervention', 'patients with small coronary vessel lesions treated with 3 dissimilar types of drug-eluting stents']","['Biodegradable Polymer and Durable Polymer Drug-eluting Stents', 'ultrathin-strut sirolimus-eluting stents, very thin-strut everolimus-eluting stents, or previous-generation thin-strut zotarolimus-eluting stents']","['revascularization rate', 'cardiac death, target vessel myocardial infarction, or stent thrombosis', 'target lesion revascularization rate', 'target lesion revascularizations', 'Main Outcomes and Measures\n\n\nTarget lesion failure at 3-year follow-up, a composite of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization, analyzed by Kaplan-Meier methods', 'Target lesion failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0441295', 'cui_str': 'Strut (physical object)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0010075', 'cui_str': 'Coronary Vessels'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0225988', 'cui_str': 'Structure of small blood vessel (organ)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0443202', 'cui_str': 'Dissimilar (qualifier value)'}, {'cui': 'C0457591', 'cui_str': 'Type of drug (attribute)'}]","[{'cui': 'C0032521', 'cui_str': 'Polymers'}, {'cui': 'C1322815', 'cui_str': 'Drug-Eluting Stents'}, {'cui': 'C0441295', 'cui_str': 'Strut (physical object)'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C1700035', 'cui_str': 'zotarilumus'}]","[{'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]",1506.0,0.0929333,"There was a difference in target lesion revascularizations between sirolimus-eluting and zotarolimus-eluting stents (2.1% vs 5.3%; HR, 0.40; 95% CI, 0.20-0.81; P = .009) that emerged after the first year of follow-up (1.0% vs 3.7%; P = .006); multivariate analysis showed that sirolimus-eluting stent implantation was independently associated with a lower target lesion revascularization rate at 3-year follow-up (adjusted HR, 0.42; 95% CI, 0.20-0.85; P = .02).","[{'ForeName': 'Rosaly A', 'Initials': 'RA', 'LastName': 'Buiten', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Eline H', 'Initials': 'EH', 'LastName': 'Ploumen', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Zocca', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Carine J M', 'Initials': 'CJM', 'LastName': 'Doggen', 'Affiliation': 'Department of Health Technology and Services Research, Faculty BMS, Technical Medical Centre, University of Twente, Enschede, the Netherlands.'}, {'ForeName': 'Liefke C', 'Initials': 'LC', 'LastName': 'van der Heijden', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Marlies M', 'Initials': 'MM', 'LastName': 'Kok', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Danse', 'Affiliation': 'Department of Cardiology, Rijnstate Hospital, Arnhem, the Netherlands.'}, {'ForeName': 'Carl E', 'Initials': 'CE', 'LastName': 'Schotborgh', 'Affiliation': 'Department of Cardiology, Haga Hospital, The Hague, the Netherlands.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Scholte', 'Affiliation': 'Department of Cardiology, Albert Schweitzer Hospital, Dordrecht, the Netherlands.'}, {'ForeName': 'Frits H A F', 'Initials': 'FHAF', 'LastName': 'de Man', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Gerard C M', 'Initials': 'GCM', 'LastName': 'Linssen', 'Affiliation': 'Department of Cardiology, Hospital Group Twente, Almelo and Hengelo, the Netherlands.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'von Birgelen', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}]",JAMA cardiology,['10.1001/jamacardio.2019.1776']
1259,30366712,Implementation intention training for prospective memory in schizophrenia: A 3-month follow-up study.,"The beneficial effect of implementation intentions (II) on prospective memory (PM) deficits in patients with schizophrenia has been reported. However, these studies were limited to brief interventions such that the transfer and long-term effects of II training remains unclear. This study examined whether a 10-session II programme could improve PM performance, social functioning and functional capacity in patients with schizophrenia immediately after training and at 3-month follow-up. Patients with schizophrenia (n = 42) recruited from the community were randomly assigned to II training (n = 21) or treatment as usual (TAU) (n = 21). Participants in the II group learned the verbal and imagery component of II and were encouraged to apply these strategies in their daily lives. We found that the II group performed better than the TAU group on computer-based PM tasks and a daily life PM task (telephone call at specified date and time) at post-treatment and at 3-month follow-up. The II group also exhibited better working ability than the TAU group at post-treatment. Our results suggest that the II intervention programme may have lasting beneficial effects in PM performance and significant transfer effects to functional capacity in schizophrenia patients.",2019,We found that the II group performed better than the TAU group on computer-based PM tasks and a daily life PM task (telephone call at specified date and time) at post-treatment and at 3-month follow-up.,"['Patients with schizophrenia (n\u202f=\u202f42) recruited from the community', 'patients with schizophrenia immediately after training and at 3-month follow-up', 'schizophrenia patients', 'schizophrenia', 'patients with schizophrenia']","['TAU', '10-session II programme', 'II training (n\u202f=\u202f21) or treatment as usual (TAU', 'Implementation intention training']","['PM performance, social functioning and functional capacity', 'working ability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]","[{'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",42.0,0.0102842,We found that the II group performed better than the TAU group on computer-based PM tasks and a daily life PM task (telephone call at specified date and time) at post-treatment and at 3-month follow-up.,"[{'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Neuropsychology and Applied Cognitive Neuroscience Lab, CAS Key Laboratory of Mental Health, Institute of Psychology, Beijing, China; Department of Psychology, University of Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Lu-Lu', 'Initials': 'LL', 'LastName': 'Liu', 'Affiliation': 'Menzies Health Institute Queensland, School of Applied Psychology, Griffith University, Gold Coast, Australia.'}, {'ForeName': 'Ji-Fang', 'Initials': 'JF', 'LastName': 'Cui', 'Affiliation': 'Information Centre, National Institute of Education Sciences, Beijing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Neuropsychology and Applied Cognitive Neuroscience Lab, CAS Key Laboratory of Mental Health, Institute of Psychology, Beijing, China; Department of Psychology, University of Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Xiao-Jing', 'Initials': 'XJ', 'LastName': 'Qin', 'Affiliation': 'Neuropsychology and Applied Cognitive Neuroscience Lab, CAS Key Laboratory of Mental Health, Institute of Psychology, Beijing, China; Department of Psychology, University of Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Shu-Li', 'Initials': 'SL', 'LastName': 'Tao', 'Affiliation': 'Community Health Service Center, College Road, Haidian District, Beijing, China.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Neumann', 'Affiliation': 'Menzies Health Institute Queensland, School of Applied Psychology, Griffith University, Gold Coast, Australia.'}, {'ForeName': 'David H K', 'Initials': 'DHK', 'LastName': 'Shum', 'Affiliation': 'Department of Rehabilitation Sciences, Hong Kong Polytechnic University, Hong Kong, China; Neuropsychology and Applied Cognitive Neuroscience Lab, CAS Key Laboratory of Mental Health, Institute of Psychology, Beijing, China; Menzies Health Institute Queensland, School of Applied Psychology, Griffith University, Gold Coast, Australia.'}, {'ForeName': 'Eric F C', 'Initials': 'EFC', 'LastName': 'Cheung', 'Affiliation': 'Castle Peak Hospital, Hong Kong, China.'}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Neuropsychology and Applied Cognitive Neuroscience Lab, CAS Key Laboratory of Mental Health, Institute of Psychology, Beijing, China; Department of Psychology, University of Chinese Academy of Sciences, Beijing, China. Electronic address: wangya@psych.ac.cn.'}, {'ForeName': 'Raymond C K', 'Initials': 'RCK', 'LastName': 'Chan', 'Affiliation': 'Neuropsychology and Applied Cognitive Neuroscience Lab, CAS Key Laboratory of Mental Health, Institute of Psychology, Beijing, China; Department of Psychology, University of Chinese Academy of Sciences, Beijing, China.'}]",Schizophrenia research,['10.1016/j.schres.2018.10.015']
1260,31743238,"Effects of Virtual Exercise Rehabilitation In-Home Therapy Compared with Traditional Care After Total Knee Arthroplasty: VERITAS, a Randomized Controlled Trial.","BACKGROUND


Financial burden for patients, providers, and payers can reduce access to physical therapy (PT) after total knee arthroplasty (TKA). The purpose of the present study was to examine the effect of a virtual PT program on health-care costs and clinical outcomes as compared with traditional care after TKA.
METHODS


At least 10 days before unilateral TKA, patients from 4 clinical sites were enrolled and randomized 1:1 to the virtual PT program (involving an avatar [digitally simulated] coach, in-home 3-dimensional biometrics, and telerehabilitation with remote clinician oversight by a physical therapist) or to traditional PT care in the home or outpatient clinic. The primary outcome was total health-care costs for the 12-week post-hospital period. Secondary (noninferiority) outcomes included 6 and 12-week Knee injury and Osteoarthritis Outcome Score (KOOS); 6-week knee extension, knee flexion, and gait speed; and 12-week safety measures (patient-reported falls, pain, and hospital readmissions). All outcomes were analyzed on a modified intent-to-treat basis.
RESULTS


Of 306 patients (mean age, 65 years; 62.5% women) who were randomized from November 2016 to November 2017, 290 had TKA and 287 (including 143 in the virtual PT group and 144 in the usual care group) completed the trial. Virtual PT had lower costs at 12 weeks after discharge than usual care (median, $1,050 compared with $2,805; p < 0.001). Mean costs were $2,745 lower for virtual PT patients. Virtual PT patients had fewer rehospitalizations than the usual care group (12 compared with 30; p = 0.007). Virtual PT was noninferior to usual PT in terms of the KOOS at 6 weeks (difference, 0.77; 90% confidence interval [CI], -1.68 to 3.23) and 12 weeks (difference, -2.33; 90% CI, -4.98 to 0.31). Virtual PT was also noninferior to usual care at 6 weeks in terms of knee extension, knee flexion, and gait speed and at 12 weeks in terms of pain and hospital readmissions. Falls were reported by 19.4% of virtual PT patients and 14.6% of usual care patients (difference, 4.83%; 90% CI, -2.60 to 12.25).
CONCLUSIONS


Relative to traditional home or clinic PT, virtual PT with telerehabilitation for skilled clinical oversight significantly lowered 3-month health-care costs after TKA while providing similar effectiveness. These findings have important implications for patients, health systems, and payers. Virtual PT with clinical oversight should be considered for patients managed with TKA.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"Virtual PT was also noninferior to usual care at 6 weeks in terms of knee extension, knee flexion, and gait speed and at 12 weeks in terms of pain and hospital readmissions.","['306 patients (mean age, 65 years; 62.5% women) who were randomized from November 2016 to November 2017', ' 290 had TKA and 287 (including 143 in the virtual PT group and 144 in the usual care group', 'patients managed with TKA', 'After Total Knee Arthroplasty']","['Virtual Exercise Rehabilitation', 'virtual PT program (involving an avatar [digitally simulated] coach, in-home 3-dimensional biometrics, and telerehabilitation with remote clinician oversight by a physical therapist) or to traditional PT care in the home or outpatient clinic', 'virtual PT program', 'Traditional Care']","['health-care costs and clinical outcomes', '6 and 12-week Knee injury and Osteoarthritis Outcome Score (KOOS); 6-week knee extension, knee flexion, and gait speed; and 12-week safety measures (patient-reported falls, pain, and hospital readmissions', 'Falls', 'Mean costs', 'total health-care costs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517682', 'cui_str': '287 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C4042802', 'cui_str': 'Tele-rehabilitation'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}]","[{'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",306.0,0.0986448,"Virtual PT was also noninferior to usual care at 6 weeks in terms of knee extension, knee flexion, and gait speed and at 12 weeks in terms of pain and hospital readmissions.","[{'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Prvu Bettger', 'Affiliation': 'Departments of Orthopaedic Surgery (J.P.B., R.C.M., and T.M.S.) and Physical and Occupational Therapy (B.T.H. and A.J.d.L.), Duke University, Durham, North Carolina.'}, {'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Green', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'DaJuanicia N', 'Initials': 'DN', 'LastName': 'Holmes', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Anang', 'Initials': 'A', 'LastName': 'Chokshi', 'Affiliation': 'Reflexion Health, San Diego, California.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Mather', 'Affiliation': 'Departments of Orthopaedic Surgery (J.P.B., R.C.M., and T.M.S.) and Physical and Occupational Therapy (B.T.H. and A.J.d.L.), Duke University, Durham, North Carolina.'}, {'ForeName': 'Bryan T', 'Initials': 'BT', 'LastName': 'Hoch', 'Affiliation': 'Departments of Orthopaedic Surgery (J.P.B., R.C.M., and T.M.S.) and Physical and Occupational Therapy (B.T.H. and A.J.d.L.), Duke University, Durham, North Carolina.'}, {'ForeName': 'Arthur J', 'Initials': 'AJ', 'LastName': 'de Leon', 'Affiliation': 'Departments of Orthopaedic Surgery (J.P.B., R.C.M., and T.M.S.) and Physical and Occupational Therapy (B.T.H. and A.J.d.L.), Duke University, Durham, North Carolina.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Aluisio', 'Affiliation': 'Greensboro Orthopaedics, Greensboro, North Carolina.'}, {'ForeName': 'Thorsten M', 'Initials': 'TM', 'LastName': 'Seyler', 'Affiliation': 'Departments of Orthopaedic Surgery (J.P.B., R.C.M., and T.M.S.) and Physical and Occupational Therapy (B.T.H. and A.J.d.L.), Duke University, Durham, North Carolina.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Del Gaizo', 'Affiliation': 'University of North Carolina at Chapel Hill Orthopaedics, Chapel Hill, North Carolina.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chiavetta', 'Affiliation': 'Raleigh Orthopaedics, Raleigh, North Carolina.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Webb', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Miller', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Smith', 'Affiliation': 'Reflexion Health, San Diego, California.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Peterson', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.00695']
1261,31851351,Effect of Concurrent Chemoradiation With Celecoxib vs Concurrent Chemoradiation Alone on Survival Among Patients With Non-Small Cell Lung Cancer With and Without Cyclooxygenase 2 Genetic Variants: A Phase 2 Randomized Clinical Trial.,"Importance


Treatment of locally advanced non-small cell lung cancer (NSCLC) remains challenging. The rationale of combining a cyclooxygenase 2 (COX-2) inhibitor with concurrent chemoradiation (CCRT) was based on results of preclinical research and prospective clinical studies; however, no randomized clinical trial has provided evidence of a direct comparison with CCRT alone.
Objective


To determine the effect of combined selective COX-2 inhibition with standard CCRT on survival among patients with unresectable stage III NSCLC.
Design, Setting, and Participants


A single-center, open-label, randomized phase 2 clinical trial was performed among 96 patients who had histologically and cytologically confirmed unresectable stage III NSCLC. Participants were enrolled from November 2011 to August 2015. Data were analyzed from February to October 2018.
Intervention


Patients were randomized to receive thoracic radiation, 60 Gy, for 6 weeks concurrent with etoposide and cisplatin or the same regimen of CCRT combined with 200 mg of celecoxib, taken twice daily.
Main Outcomes and Measures


The primary end point was overall survival. The secondary end points were the proportion of patients with treatment-related toxic effects, progression-free survival, and overall survival in subgroups with and without the COX-2 genotype.
Results


A total of 100 patients were randomized. Following the exclusion of 4 outliers, 96 participants (96.0%) were analyzed (51 randomized to CCRT alone and 45 randomized to CCRT with celecoxib; mean [SD] age, 60.0 [8.3] years; 73.0 [76.0%] male). The median overall survival time was 32.8 (95% CI, 17.0-48.5) months in the group that received CCRT with celecoxib and 35.5 (95% CI, 25.8-45.2) months in the group that received CCRT alone (P = .88). Celecoxib with CCRT was well tolerated; the incidence of symptomatic radiation pneumonitis was 6.6% (95% CI, 1.4%-18.0%) in the group that received CCRT with celecoxib and 11.8% (95% CI, 4.4%-23.9%) in the group that received CCRT alone (P = .49). Among patients with the high-risk genotype, celecoxib plus CCRT was not associated with higher progression-free survival (hazard ratio, 0.36; 95% CI, 0.13-1.04; P = .05) or overall survival (hazard ratio, 0.50; 95% CI, 0.15-1.72; P = .26) compared with CCRT alone.
Conclusions and Relevance


In unresectable stage III NSCLC, adding celecoxib to concurrent chemoradiation did not improve survival. A smaller, not statistically significant proportion of patients in the CCRT with celecoxib group compared with the CCRT alone group developed symptomatic radiation pneumonitis. Among patients with the high-risk genotype, adding celecoxib to CCRT did not improve overall or progression-free survival.
Trial Registration


ClinicalTrials.gov identifier: NCT01503385.",2019,"Celecoxib with CCRT was well tolerated; the incidence of symptomatic radiation pneumonitis was 6.6% (95% CI, 1.4%-18.0%) in the group that received CCRT with celecoxib and 11.8% (95% CI, 4.4%-23.9%) in the group that received CCRT alone (P = .49).","['patients with unresectable stage III NSCLC', 'Patients With Non-Small Cell Lung Cancer', 'locally advanced non-small cell lung cancer (NSCLC', 'Participants were enrolled from November 2011 to August 2015', '96 participants (96.0%) were analyzed (51 randomized to', 'patients with the high-risk genotype', '100 patients were randomized', '96 patients who had histologically and cytologically confirmed unresectable stage III NSCLC', 'mean [SD] age, 60.0 [8.3] years; 73.0 [76.0%] male']","['celecoxib plus CCRT', 'celecoxib', 'CCRT with celecoxib', 'Concurrent Chemoradiation', 'thoracic radiation', 'CCRT', 'etoposide and cisplatin', 'Celecoxib', 'CCRT combined with 200 mg of celecoxib', 'celecoxib to CCRT', 'combined selective COX-2 inhibition with standard CCRT', 'Cyclooxygenase', 'cyclooxygenase 2 (COX-2) inhibitor with concurrent chemoradiation (CCRT', 'Celecoxib with CCRT']","['progression-free survival', 'proportion of patients with treatment-related toxic effects, progression-free survival, and overall survival', 'median overall survival time', 'overall survival', 'survival', 'symptomatic radiation pneumonitis', 'tolerated; the incidence of symptomatic radiation pneumonitis', 'overall or progression-free survival', 'Survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0442996', 'cui_str': 'Cox (qualifier value)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033551', 'cui_str': 'Prostaglandin H2 Synthetase'}, {'cui': 'C0387583', 'cui_str': 'COX-2 Prostaglandin Synthase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0206063', 'cui_str': 'Pneumonia, Radiation'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",96.0,0.39904,"Celecoxib with CCRT was well tolerated; the incidence of symptomatic radiation pneumonitis was 6.6% (95% CI, 1.4%-18.0%) in the group that received CCRT with celecoxib and 11.8% (95% CI, 4.4%-23.9%) in the group that received CCRT alone (P = .49).","[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Bi', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center and Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center and Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Zongmei', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center and Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Dongfu', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center and Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Zhixue', 'Initials': 'Z', 'LastName': 'Fu', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center and Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center and Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'QinFu', 'Initials': 'Q', 'LastName': 'Feng', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center and Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Zhouguang', 'Initials': 'Z', 'LastName': 'Hui', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center and Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Zefen', 'Initials': 'Z', 'LastName': 'Xiao', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center and Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Jima', 'Initials': 'J', 'LastName': 'Lv', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center and Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Xiaozhen', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center and Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center and Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center and Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Deng', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center and Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Wenqing', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center and Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Jingbo', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center and Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Lipin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center and Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Division of Biostatistics and Bioinformatics, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Luhua', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center and Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.18070']
1262,30298469,Predictive factors of the treatment outcome in patients with advanced biliary tract cancer receiving gemcitabine plus cisplatin as first-line chemotherapy.,"BACKGROUND


Few studies have clearly identified the prognostic factors in patients with advanced biliary tract cancer (BTC) receiving gemcitabine plus cisplatin (GC) which is acknowledged as standard chemotherapy regimen.
OBJECTIVES


The aim of this study was to identify predictive factors of the overall survival (OS) in advanced BTC patients receiving GC therapy.
METHODS


Data of 307 patients with advanced BTC who received GC therapy as the first-line chemotherapy at our institution from January 2007 to June 2017 were reviewed retrospectively. The patients were randomly assigned to the investigation or the validation dataset at the ratio of 2:1. Multivariate analysis was conducted to identify the prognostic factors, a prognostic index is proposed from the investigation dataset, and the usefulness of this index was confirmed in the validation dataset.
RESULTS


Multivariate analysis identified poor performance status, elevated serum lactate dehydrogenase, and elevated neutrophil-to-lymphocyte ratio as independent unfavorable predictors. The patients could be classified into three groups according to these factors, and it was found that the outcomes differed significantly among the three groups (P = 0.0002, good- vs. intermediate-prognosis groups; P = 0.005, intermediate- vs. poor-prognosis groups). When this index was applied to the validation dataset, the OS was confirmed to differ significantly among the three groups (P = 0.04, good- vs. intermediate-prognosis groups, P < 0.0001, intermediate- vs. poor-prognosis groups).
CONCLUSIONS


We identified three predictors of the OS in patients with advanced BTC receiving GC therapy in this study, based on which we could classify the patients into three risk groups.",2019,"When this index was applied to the validation dataset, the OS was confirmed to differ significantly among the three groups (P = 0.04, good- vs. intermediate-prognosis groups, P < 0.0001, intermediate- vs. poor-prognosis groups).
","['advanced BTC patients receiving GC therapy', 'patients with advanced biliary tract cancer receiving', 'patients with advanced biliary tract cancer (BTC) receiving', 'as first-line chemotherapy', '307 patients with advanced BTC who received GC therapy as the first-line chemotherapy at our institution from January 2007 to June 2017 were reviewed retrospectively', 'patients with advanced BTC receiving']","['gemcitabine plus cisplatin', 'gemcitabine plus cisplatin (GC', 'GC therapy']","['performance status, elevated serum lactate dehydrogenase, and elevated neutrophil-to-lymphocyte ratio', 'overall survival (OS']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0750952', 'cui_str': 'Biliary Tract Cancer'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1278052', 'cui_str': 'Serum lactate dehydrogenase measurement'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",307.0,0.0143783,"When this index was applied to the validation dataset, the OS was confirmed to differ significantly among the three groups (P = 0.04, good- vs. intermediate-prognosis groups, P < 0.0001, intermediate- vs. poor-prognosis groups).
","[{'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, 277-8577, Japan.'}, {'ForeName': 'Motoyasu', 'Initials': 'M', 'LastName': 'Kan', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, 277-8577, Japan.'}, {'ForeName': 'Gen', 'Initials': 'G', 'LastName': 'Kimura', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, 277-8577, Japan.'}, {'ForeName': 'Kumiko', 'Initials': 'K', 'LastName': 'Umemoto', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, 277-8577, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, 277-8577, Japan.'}, {'ForeName': 'Mitsuhito', 'Initials': 'M', 'LastName': 'Sasaki', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, 277-8577, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Takahashi', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, 277-8577, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, 277-8577, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Imaoka', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, 277-8577, Japan.'}, {'ForeName': 'Izumi', 'Initials': 'I', 'LastName': 'Ohno', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, 277-8577, Japan.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Mitsunaga', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, 277-8577, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ikeda', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, 277-8577, Japan. masikeda@east.ncc.go.jp.'}]",Journal of gastroenterology,['10.1007/s00535-018-1518-3']
1263,31103505,Does Hand Massage Have Sustained Effects on Pain Intensity and Pain-Related Interference in the Cardiac Surgery Critically Ill? A Randomized Controlled Trial.,"BACKGROUND


Despite the promising short-term pain relief effect of massage, little is known regarding its sustained effects on pain intensity and pain-related interference with functioning.
AIMS


To evaluate the sustained effect of hand massage on the pain intensity and pain-related interference with functioning of cardiac surgery patients.
DESIGN


A randomized controlled trial.
SETTINGS


A medical-surgical intensive care unit in Canada.
PARTICIPANTS/SUBJECTS


Adult patients undergoing cardiac surgery and at low risk for postoperative complications were eligible.
METHODS


In the intensive care unit, patients were randomly assigned to either 20-minute hand massage, hand holding, or rest. Pain intensity and pain-related interference with functioning were assessed on the second postoperative day.
RESULTS


A total of 60 patients were randomly allocated and 46 completed data collection on the second postoperative day. Although no significant differences were identified across groups, the hand massage group reported a maximum pain intensity (median 5.75, range: 2-10) that was lower than the hand-holding (median 6.50, range: 1-10) and standard care groups (median 6.25, range: 0-10). The hand massage group could reach 0 pain intensity throughout a 24-hour period (median 0, range: 0-7), contrary to the hand-holding (median 2, range: 0-5) and standard care groups (median 2, range: 0-4.5). A trend for statistical significance was noted for dichotomized ratings on pain interference with walking (p = .176) and sleep (p = .050).
CONCLUSIONS


Hand massage could help patients experience longer periods without pain and lower levels of maximum pain intensity. When coupled with recovery activities, hand massage could reduce pain-related interference with functioning.",2019,"A trend for statistical significance was noted for dichotomized ratings on pain interference with walking (p = .176) and sleep (p = .050).
","['cardiac surgery patients', '60 patients', 'Adult patients undergoing cardiac surgery and at low risk for postoperative complications were eligible']","['hand massage', '20-minute hand massage, hand holding, or rest']","['maximum pain intensity', 'reach 0 pain intensity', 'pain intensity and pain', 'Pain intensity and pain-related interference with functioning', 'Pain Intensity and Pain-Related Interference']","[{'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",60.0,0.204205,"A trend for statistical significance was noted for dichotomized ratings on pain interference with walking (p = .176) and sleep (p = .050).
","[{'ForeName': 'Madalina', 'Initials': 'M', 'LastName': 'Boitor', 'Affiliation': 'Ingram School of Nursing, McGill University, 680 Sherbrooke West, Montréal, Québec, Canada. Electronic address: madalina.boitor@mail.mcgill.ca.'}, {'ForeName': 'Géraldine', 'Initials': 'G', 'LastName': 'Martorella', 'Affiliation': 'College of Nursing, Florida State University, Tallahassee, Florida.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Maheu', 'Affiliation': 'Ingram School of Nursing, McGill University, 680 Sherbrooke West, Montréal, Québec, Canada.'}, {'ForeName': 'Andréa Maria', 'Initials': 'AM', 'LastName': 'Laizner', 'Affiliation': 'Ingram School of Nursing, McGill University, 680 Sherbrooke West, Montréal, Québec, Canada.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Gélinas', 'Affiliation': 'Ingram School of Nursing, McGill University, 680 Sherbrooke West, Montréal, Québec, Canada.'}]",Pain management nursing : official journal of the American Society of Pain Management Nurses,['10.1016/j.pmn.2019.02.011']
1264,31107710,PEELING OF THE INTERNAL LIMITING MEMBRANE WITH FOVEAL SPARING FOR TREATMENT OF DEGENERATIVE LAMELLAR MACULAR HOLE.,"PURPOSE


To compare the functional and anatomical results of fovea-sparing internal limiting membrane peeling during vitrectomy with those of observation for degenerative lamellar macular hole with lamellar hole-associated epiretinal proliferation.
DESIGN


A prospective, randomized, comparative pilot study.
METHODS


Thirty-six eyes were randomized to undergo surgery with foveal internal limiting membrane sparing (Group S) or observation only (Group C). The main outcome measures were foveal retinal sensitivity, visual acuity, and central retinal thickness.
RESULTS


After 6 months, a significant difference was found in foveal retinal sensitivity between Group S (12.8 ± 1.7 dB) and Group C (9.39 ± 1.8 dB; P < 0.001). Similarly, best-corrected visual acuity improved in Group S and remained stable in Group C (respectively, 0.17 ± 0.13 and 0.46 ± 0.21 logMAR; P < 0.001). A significant increase in central retinal thickness was observed in Group S, but not in Group C (272 ± 24 vs. 147 ± 20 µm, P < 0.001).
CONCLUSION


Fovea-sparing internal limiting membrane peeling is a feasible treatment for degenerative lamellar macular hole with lamellar hole-associated epiretinal proliferation, yielding better improvements in best-corrected visual acuity and foveal retinal sensitivity than observation alone. Further studies are needed to optimize this new surgical approach.",2020,"Similarly, best-corrected visual acuity improved in Group S and remained stable in Group C (respectively, 0.17 ± 0.13 and 0.46 ± 0.21 logMAR; P < 0.001).",['Thirty-six eyes'],"['surgery with foveal internal limiting membrane sparing (Group S) or observation only (Group C', 'Fovea-sparing internal limiting membrane peeling', 'fovea-sparing internal limiting membrane peeling during vitrectomy']","['foveal retinal sensitivity', 'central retinal thickness', 'foveal retinal sensitivity, visual acuity, and central retinal thickness', 'best-corrected visual acuity']","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0441853', 'cui_str': 'Group S (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}]","[{'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}]",36.0,0.0446705,"Similarly, best-corrected visual acuity improved in Group S and remained stable in Group C (respectively, 0.17 ± 0.13 and 0.46 ± 0.21 logMAR; P < 0.001).","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Morescalchi', 'Affiliation': 'Department of Neurological and Vision Sciences, Eye Clinic, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Russo', 'Affiliation': 'Department of Neurological and Vision Sciences, Eye Clinic, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Gambicorti', 'Affiliation': 'Department of Neurological and Vision Sciences, Eye Clinic, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Cancarini', 'Affiliation': 'Department of Neurological and Vision Sciences, Eye Clinic, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Nicolò', 'Initials': 'N', 'LastName': 'Scaroni', 'Affiliation': 'Department of Neurological and Vision Sciences, Eye Clinic, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Bahja', 'Affiliation': 'Department of Neurological and Vision Sciences, Eye Clinic, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Ciro', 'Initials': 'C', 'LastName': 'Costagliola', 'Affiliation': 'Department of Health Sciences, Eye Clinic, University of Molise, Campobasso, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Semeraro', 'Affiliation': 'Department of Neurological and Vision Sciences, Eye Clinic, University of Brescia, Brescia, Italy.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002559']
1265,31097405,"Pomalidomide, bortezomib, and dexamethasone for patients with relapsed or refractory multiple myeloma previously treated with lenalidomide (OPTIMISMM): a randomised, open-label, phase 3 trial.","BACKGROUND


As lenalidomide becomes increasingly established for upfront treatment of multiple myeloma, patients refractory to this drug represent a population with an unmet need. The combination of pomalidomide, bortezomib, and dexamethasone has shown promising results in phase 1/2 trials of patients with relapsed or refractory multiple myeloma. We aimed to assess the efficacy and safety of this triplet regimen in patients with relapsed or refractory multiple myeloma who previously received lenalidomide.
METHODS


We did a randomised, open-label, phase 3 trial at 133 hospitals and research centres in 21 countries. We enrolled patients (aged ≥18 years) with a diagnosis of multiple myeloma and measurable disease, an Eastern Cooperative Oncology Group performance status of 0-2, who received one to three previous regimens, including a lenalidomide-containing regimen for at least two consecutive cycles. We randomly assigned patients (1:1) to bortezomib and dexamethasone with or without pomalidomide using a permutated blocked design in blocks of four, stratified according to age, number of previous regimens, and concentration of β 2  microglobulin at screening. Bortezomib (1·3 mg/m 2 ) was administered intravenously until protocol amendment 1 then either intravenously or subcutaneously on days 1, 4, 8, and 11 for the first eight cycles and subsequently on days 1 and 8. Dexamethasone (20 mg [10 mg if age >75 years]) was administered orally on the same days as bortezomib and the day after. Patients allocated pomalidomide received 4 mg orally on days 1-14. Treatment cycles were every 21 days. The primary endpoint was progression-free survival in the intention-to-treat population, as assessed by an independent review committee. Safety was assessed in all patients who received at least one dose of study medication. This trial is registered at ClinicalTrials.gov, number NCT01734928; patients are no longer being enrolled.
FINDINGS


Between Jan 7, 2013, and May 15, 2017, 559 patients were enrolled. 281 patients were assigned pomalidomide, bortezomib, and dexamethasone and 278 were allocated bortezomib and dexamethasone. Median follow-up was 15·9 months (IQR 9·9-21·7). Pomalidomide, bortezomib, and dexamethasone significantly improved progression-free survival compared with bortezomib and dexamethasone (median 11·20 months [95% CI 9·66-13·73] vs 7·10 months [5·88-8·48]; hazard ratio 0·61, 95% CI 0·49-0·77; p<0·0001). 278 patients received at least one dose of pomalidomide, bortezomib, and dexamethasone and 270 patients received at least one dose of bortezomib and dexamethasone, and these patients were included in safety assessments. The most common grade 3 or 4 treatment-emergent adverse events were neutropenia (116 [42%] of 278 patients vs 23 [9%] of 270 patients; nine [3%] vs no patients had febrile neutropenia), infections (86 [31%] vs 48 [18%]), and thrombocytopenia (76 [27%] vs 79 [29%]). Serious adverse events were reported in 159 (57%) of 278 patients versus 114 (42%) of 270 patients. Eight deaths were related to treatment; six (2%) were recorded in patients who received pomalidomide, bortezomib, and dexamethasone (pneumonia [n=2], unknown cause [n=2], cardiac arrest [n=1], cardiorespiratory arrest [n=1]) and two (1%) were reported in patients who received bortezomib and dexamethasone (pneumonia [n=1], hepatic encephalopathy [n=1]).
INTERPRETATION


Patients with relapsed or refractory multiple myeloma who previously received lenalidomide had significantly improved progression-free survival when treated with pomalidomide, bortezomib, and dexamethasone compared with bortezomib and dexamethasone. Adverse events accorded with the individual profiles of pomalidomide, bortezomib, and dexamethasone. This study supports use of pomalidomide, bortezomib, and dexamethasone as a treatment option in patients with relapsed or refractory multiple myeloma who previously received lenalidomide.
FUNDING


Celgene.",2019,"Pomalidomide, bortezomib, and dexamethasone significantly improved progression-free survival compared with bortezomib and dexamethasone (median 11·20 months","['pneumonia [n=2], unknown cause [n=2], cardiac arrest [n=1], cardiorespiratory arrest [n=1]) and two (1%) were reported in patients who received', 'patients with relapsed or refractory multiple myeloma previously treated with lenalidomide (OPTIMISMM', '133 hospitals and research centres in 21 countries', '559 patients were enrolled', '281 patients were assigned', 'patients with relapsed or refractory multiple myeloma', 'Patients with relapsed or refractory multiple myeloma who previously received', '278 patients received at least one dose of', 'Between Jan 7, 2013, and May 15, 2017', 'pneumonia [n=1], hepatic encephalopathy [n=1', 'patients with relapsed or refractory multiple myeloma who previously received lenalidomide', 'enrolled patients (aged ≥18 years) with a diagnosis of multiple myeloma and measurable disease, an Eastern Cooperative Oncology Group performance status of 0-2, who received one to three previous regimens, including a lenalidomide-containing regimen for at least two consecutive cycles']","['Bortezomib', 'Pomalidomide, bortezomib, and dexamethasone', 'bortezomib and dexamethasone with or without pomalidomide', 'Dexamethasone', 'pomalidomide, bortezomib', 'bortezomib and dexamethasone', 'pomalidomide, bortezomib, and dexamethasone', 'bortezomib', 'lenalidomide', 'dexamethasone']","['Adverse events', 'thrombocytopenia', 'progression-free survival', 'neutropenia', 'febrile neutropenia), infections', 'Serious adverse events', 'efficacy and safety', 'Safety']","[{'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0600228', 'cui_str': 'Cardiopulmonary Arrest'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0035168'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0019151', 'cui_str': 'Portal-Systemic Encephalopathy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C2347624', 'cui_str': 'pomalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",559.0,0.267835,"Pomalidomide, bortezomib, and dexamethasone significantly improved progression-free survival compared with bortezomib and dexamethasone (median 11·20 months","[{'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Richardson', 'Affiliation': 'Jerome Lipper Multiple Myeloma Center, Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA. Electronic address: paul_richardson@dfci.harvard.edu.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Oriol', 'Affiliation': ""Institut Català d'Oncologia and Institut Josep Carreras, Hospital Germans Trias i Pujol, Barcelona, Spain.""}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Beksac', 'Affiliation': 'Ankara University, Ankara, Turkey.'}, {'ForeName': 'Anna Marina', 'Initials': 'AM', 'LastName': 'Liberati', 'Affiliation': 'Università degli studi di Perugia, Perugia, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Galli', 'Affiliation': 'Azienda Ospedaliera Papa Giovanni XXIII, Unità Operativa di Ematologia, Bergamo, Italy.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Schjesvold', 'Affiliation': 'Oslo Myeloma Center, Oslo University Hospital, Oslo, Norway; K G Jebsen Center for B Cell Malignancies, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Jindriska', 'Initials': 'J', 'LastName': 'Lindsay', 'Affiliation': 'East Kent Hospitals University NHS Foundation Trust, Kent and Canterbury Hospital, Canterbury, UK.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Weisel', 'Affiliation': 'Department of Oncology, Hematology and Bone Marrow Transplantation with Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Darrell', 'Initials': 'D', 'LastName': 'White', 'Affiliation': 'Dalhousie University and Queen Elizabeth II Health Sciences Centre, Halifax, NS, Canada.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Facon', 'Affiliation': 'University of Lille, Centre Hospitalier Universitaire Lille, Service des Maladies du Sang, Lille, France.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'San Miguel', 'Affiliation': 'Clinica Universidad de Navarra, Centro de Investigación Médica Aplicada, Instituto de Investigación Sanitaria de Navarra, Pamplona, Spain.'}, {'ForeName': 'Kazutaka', 'Initials': 'K', 'LastName': 'Sunami', 'Affiliation': 'National Hospital Organization Okayama Medical Center, Okayama, Japan.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': ""O'Gorman"", 'Affiliation': 'Department of Haematology, Mater Misericordiae University Hospital, Dublin, Ireland; Cancer Trials Ireland, School of Medicine and Medical Science, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Sonneveld', 'Affiliation': 'Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Robak', 'Affiliation': 'Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Semochkin', 'Affiliation': 'Pirogov Russian National Research Medical University, Moscow, Russia.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Schey', 'Affiliation': ""Department of Hematology, King's College London, London, UK.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Doerr', 'Affiliation': 'Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'Amine', 'Initials': 'A', 'LastName': 'Bensmaine', 'Affiliation': 'Celgene International, Boudry, Switzerland.'}, {'ForeName': 'Tsvetan', 'Initials': 'T', 'LastName': 'Biyukov', 'Affiliation': 'Celgene International, Boudry, Switzerland.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Peluso', 'Affiliation': 'Celgene International, Boudry, Switzerland.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Zaki', 'Affiliation': 'Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Anderson', 'Affiliation': 'Jerome Lipper Multiple Myeloma Center, Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Meletios', 'Initials': 'M', 'LastName': 'Dimopoulos', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30152-4']
1266,31509849,"Autologous Cell Therapy for Aged Human Skin: A Randomized, Placebo-Controlled, Phase-I Study.","INTRODUCTION


Skin ageing involves senescent fibroblast accumulation, disturbance in extracellular matrix (ECM) homeostasis, and decreased collagen synthesis.
OBJECTIVE


to assess a cell therapy product for aged skin (RCS-01; verum) consisting of ~25 × 106 cultured, autologous cells derived from anagen hair follicle non-bulbar dermal sheath (NBDS).
METHODS


For each subject in the verum group, 4 areas of buttock skin were injected intradermally 1 or 3 times at monthly intervals with RCS-01, cryomedium, or needle penetration without injection; in the placebo group RCS-01 was replaced by cryomedium. The primary endpoint was assessment of local adverse event profiles. As secondary endpoints, expression of genes related to ECM homeostasis was assessed in biopsies from randomly selected volunteers in the RCS-01 group taken 4 weeks after the last injection. -Results: Injections were well tolerated with no severe adverse events reported 1 year after the first injection. When compared with placebo-treated skin, a single treatment with RCS-01 resulted in a significant upregulation of TGFβ1, CTGF, COL1A1, COL1A2, COL3A1, and lumican mRNA expression.
LIMITATIONS


The cohort size was insufficient for dose -ranging evaluation and subgroup analyses of efficacy.
CONCLUSIONS


RCS-01 therapy is well tolerated and associated with a gene expression response consistent with an improvement of ECM homeostasis.",2020,"When compared with placebo-treated skin, a single treatment with RCS-01 resulted in a significant upregulation of TGFβ1, CTGF, COL1A1, COL1A2, COL3A1, and lumican mRNA expression.
","['Results', 'Aged Human Skin', 'aged skin (RCS-01; verum) consisting of ~25']","['placebo', 'Autologous Cell Therapy', 'Placebo', 'RCS-01 therapy']","['TGFβ1, CTGF, COL1A1, COL1A2, COL3A1, and lumican mRNA expression', 'expression of genes related to ECM homeostasis', 'tolerated with no severe adverse events', 'local adverse event profiles']","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1123023', 'cui_str': 'Skin'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0302189', 'cui_str': 'Cell Therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0766823', 'cui_str': 'alpha 2(I) Collagen'}, {'cui': 'C0126273', 'cui_str': 'Lumican Proteoglycan'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}]",106.0,0.0634765,"When compared with placebo-treated skin, a single treatment with RCS-01 resulted in a significant upregulation of TGFβ1, CTGF, COL1A1, COL1A2, COL3A1, and lumican mRNA expression.
","[{'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Grether-Beck', 'Affiliation': 'In vivo Unit, IUF, Leibniz Research Institute for Environmental Medicine, Düsseldorf, Germany.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Marini', 'Affiliation': 'In vivo Unit, IUF, Leibniz Research Institute for Environmental Medicine, Düsseldorf, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jaenicke', 'Affiliation': 'In vivo Unit, IUF, Leibniz Research Institute for Environmental Medicine, Düsseldorf, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Goessens-Rück', 'Affiliation': 'Consulting Service for Advanced Therapies and Biologics - CATB, Hofheim, Germany.'}, {'ForeName': 'Kevin John', 'Initials': 'KJ', 'LastName': 'McElwee', 'Affiliation': 'Replicel Life Sciences Inc., Vancouver, British Columbia, Canada.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Hoffmann', 'Affiliation': 'Replicel Life Sciences Inc., Vancouver, British Columbia, Canada.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Krutmann', 'Affiliation': 'In vivo Unit, IUF, Leibniz Research Institute for Environmental Medicine, Düsseldorf, Germany, jean.krutmann@iuf-duesseldorf.de.'}]",Skin pharmacology and physiology,['10.1159/000502240']
1267,31743788,Functional consequences of acute tryptophan depletion on raphe nuclei connectivity and network organization in healthy women.,"Previous research on central nervous serotonin (5-HT) function provided evidence for a substantial involvement of 5-HT in the regulation of brain circuitries associated with cognitive and affective processing. The underlying neural networks comprise core subcortical/cortical regions such as amygdala and medial prefrontal cortex, which are assumed to be modulated amongst others by 5-HT. Beside the use of antidepressants, acute tryptophan depletion (ATD) is a widely accepted technique to manipulate of 5-HT synthesis and its respective metabolites in humans by means of a dietary and non-pharmacological tool. We used a double-blind, randomized, cross-over design with two experimental challenge conditions, i.e. ATD and tryptophan (TRP) supplementation (TRYP+) serving as a control. The aim was to perturb 5-HT synthesis and to detect its impact on brain functional connectivity (FC) of the upper serotonergic raphe nuclei, the amygdala and the ventromedial prefrontal cortex as well as on network organization using resting state fMRI. 30 healthy adult female participants (age: M ​= ​24.5 ​± ​4.4 ​yrs) were included in the final analysis. ATD resulted in a 90% decrease of TRP in the serum relative to baseline. Compared to TRYP ​+ ​for the ATD condition a significantly lower FC of the raphe nucleus to the frontopolar cortex was detected, as well as greater functional coupling between the right amygdala and the ventromedial prefrontal cortex. FC of the raphe nucleus correlated significantly with the magnitude of TRP changes for both challenge conditions (ATD & TRYP+). Network-based statistical analysis using time series from 260 independent anatomical ROIs revealed significantly greater FC after ATD compared to TRYP+ in several brain regions being part of the default-mode (DMN) and the executive-control networks (ECN), but also of salience or visual networks. Finally, we observed an impact of ATD on the rich-club organization in terms of decreased rich-club coefficients compared to TRYP+. In summary we could confirm previous findings that the putative decrease in brain 5-HT synthesis via ATD significantly alters FC of the raphe nuclei as well as of specific subcortical/cortical regions involved in affective, but also in cognitive processes. Moreover, an ATD-effect on the so-called rich-club organization of some nodes with the high degree was demonstrated. This may indicate effects of brain 5-HT on the integration of information flow from several brain networks.",2020,"Compared to TRYP + for the ATD condition a significantly lower FC of the raphe nucleus to the frontopolar cortex was detected, as well as greater functional coupling between the right amygdala and the ventromedial prefrontal cortex.","['healthy women', '30 healthy adult female participants (age: M\xa0=\xa024.5\xa0±\xa04.4\xa0yrs']","['ATD and tryptophan (TRP) supplementation (TRYP', 'acute tryptophan depletion', 'TRYP']",['TRP'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517761', 'cui_str': '4.4'}]","[{'cui': 'C0041249', 'cui_str': 'L-tryptophan'}, {'cui': 'C0333668', 'cui_str': 'Depletion (morphologic abnormality)'}]",[],30.0,0.024005,"Compared to TRYP + for the ATD condition a significantly lower FC of the raphe nucleus to the frontopolar cortex was detected, as well as greater functional coupling between the right amygdala and the ventromedial prefrontal cortex.","[{'ForeName': 'Karl-Jürgen', 'Initials': 'KJ', 'LastName': 'Bär', 'Affiliation': 'Psychiatric Brain and Body Research Group, Department of Psychiatry and Psychotherapy, Jena University Hospital, Jena, Germany. Electronic address: Karl-Juergen.Baer@med.uni-jena.de.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Köhler', 'Affiliation': 'Psychiatric Brain and Body Research Group, Department of Psychiatry and Psychotherapy, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Feliberto de la', 'Initials': 'F', 'LastName': 'Cruz', 'Affiliation': 'Psychiatric Brain and Body Research Group, Department of Psychiatry and Psychotherapy, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Schumann', 'Affiliation': 'Psychiatric Brain and Body Research Group, Department of Psychiatry and Psychotherapy, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Florian D', 'Initials': 'FD', 'LastName': 'Zepf', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatic Medicine and Psychotherapy, Jena University Hospital, Friedrich Schiller University, 07743, Jena, Germany.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Wagner', 'Affiliation': 'Psychiatric Brain and Body Research Group, Department of Psychiatry and Psychotherapy, Jena University Hospital, Jena, Germany. Electronic address: wagner.gerd@uni-jena.de.'}]",NeuroImage,['10.1016/j.neuroimage.2019.116362']
1268,31096843,Effects of a web-based expert support self-management program (WEST) for women with breast cancer: A randomized controlled trial.,"INTRODUCTION


This study was a randomized controlled trial that examined the effects of a web-based expert support self-management program (WEST) on metabolic syndrome risk factors and self-efficacy among Korean women with breast cancer.
METHODS


Participants were 60 women with breast cancer (30 participants each in both the experimental and control groups) who also had metabolic risk factors. WEST is based on the self-efficacy theory and is a self-health management program consisting of a web-based program, DIETEX (which entails keeping a health diary, identifying a lifestyle type, inputting personal health information), and expert support. WEST was provided to the experimental group once a week for 24 weeks. Metabolic syndrome risk factors and self-efficacy of the experimental and control groups were examined pre-intervention and at 12 and 24 weeks after intervention.
RESULTS


The decreases in body fat, body fat percentage, and waist circumference were greater in the experimental group than in the control group at 24 weeks ( p  = 0.019,  p  = 0.025, and  p  = 0.038, respectively).
DISCUSSION


The present study can provide basic data for the development and application of interventions for women with breast cancer in the future. Additionally, we propose that WEST be included in the treatment process to complement the intervention of medical personnel for improving metabolic risk factors in women with breast cancer.",2019,"The decreases in body fat, body fat percentage, and waist circumference were greater in the experimental group than in the control group at 24 weeks ( p = 0.019, p = 0.025, and p = 0.038, respectively).
","['women with breast cancer', 'Participants were 60 women with breast cancer (30 participants each in both the experimental and control groups) who also had metabolic risk factors', 'women with breast cancer in the future', 'Korean women with breast cancer']",['web-based expert support self-management program (WEST'],"['metabolic syndrome risk factors and self-efficacy', 'body fat, body fat percentage, and waist circumference', 'Metabolic syndrome risk factors and self-efficacy', 'metabolic risk factors']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}]",60.0,0.0315839,"The decreases in body fat, body fat percentage, and waist circumference were greater in the experimental group than in the control group at 24 weeks ( p = 0.019, p = 0.025, and p = 0.038, respectively).
","[{'ForeName': 'Hye-Jin', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, University of Ulsan, The Republic of Korea.'}, {'ForeName': 'Hee-Seung', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'College of Nursing, The Catholic University of Korea, Seoul, The Republic of Korea.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19850386']
1269,31743542,"Effect of a sphingolipid-mimetic compound on the promotion of hair growth: A randomized, double-blind, placebo-controlled clinical trial.","BACKGROUND


Pattern hair loss is a very common skin disorder, but more therapeutic modalities for hair growth are still required.
OBJECTIVE


We investigated the effect of a newly synthesized sphingolipid-mimetic compound (pseudo-ceramide: bis-oleamide isopropyl alcohol [BOI]) on the promotion of hair growth for patients with mild pattern hair loss.
METHODS


A total of 58 patients with mild pattern hair loss participated in this clinical trial. A randomized, double-blind, placebo-controlled clinical trial was conducted for 6 months. Participants in the experimental group applied 1% BOI lotion (ceramide HS) on the whole scalp once a day for 6 months. Participants in the control group applied simulacrum using the same protocol. We evaluated daily hair loss, hair density, hair thickness, and hair length at intervals of 3 months; patient satisfaction and adverse events were evaluated at 6 months.
RESULTS


At 6 months in the experimental group, daily hair loss at baseline (52.52 ± 33.98) decreased to 40.41 ± 24.78, vertex hair density at baseline (131.07 ± 43.73) increased to 156.00 ± 39.59, frontal hair density at baseline (104.21 ± 30.72) increased to 124.10 ± 28.28, thickness of vertex hair at baseline (0.067 ± 0.012 cm) increased to 0.075 ± 0.014 cm, thickness of frontal hair at baseline (0.070 ± 0.009 cm) increased to 0.076 ± 0.012 cm, and hair growth rate was 16.17 ± 1.89 mm/month.
CONCLUSION


Ceramide HS may be a new candidate for the treatment of pattern hair loss.",2020,"At 6 months in the experimental group, daily hair loss at baseline (52.52 ± 33.98) decreased to 40.41 ± 24.78, vertex hair density at baseline (131.07 ± 43.73) increased to 156.00 ± 39.59, frontal hair density at baseline (104.21 ± 30.72) increased to 124.10 ± 28.28, thickness of vertex hair at baseline (0.067 ± 0.012 cm) increased to 0.075 ± 0.014 cm, thickness of frontal hair at baseline (0.070 ± 0.009 cm) increased to 0.076 ± 0.012 cm, and hair growth rate was 16.17 ± ","['58 patients with mild pattern hair loss participated in this clinical trial', 'patients with mild pattern hair loss']","['placebo', 'newly synthesized sphingolipid-mimetic compound (pseudo-ceramide: bis-oleamide isopropyl alcohol [BOI', 'BOI lotion (ceramide HS', 'sphingolipid-mimetic compound']","['hair growth rate', 'daily hair loss, hair density, hair thickness, and hair length at intervals of 3\xa0months; patient satisfaction and adverse events', 'vertex hair density', 'thickness of vertex hair', 'thickness of frontal hair', 'daily hair loss', 'frontal hair density', 'promotion of hair growth']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0037900', 'cui_str': 'Sphingolipids'}, {'cui': 'C0205198', 'cui_str': 'Compound (qualifier value)'}, {'cui': 'C0205237', 'cui_str': 'False (qualifier value)'}, {'cui': 'C0007745', 'cui_str': 'Ceramides'}, {'cui': 'C1872096', 'cui_str': 'bis(phenylacetylarginine)'}, {'cui': 'C0377344', 'cui_str': 'oleylamide'}, {'cui': 'C0022237', 'cui_str': 'rubbing alcohol'}, {'cui': 'C0544341', 'cui_str': 'Lotion (basic dose form)'}]","[{'cui': 'C0232407', 'cui_str': 'Hair growth, function (observable entity)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0230003', 'cui_str': 'Vertex structure'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]",58.0,0.410382,"At 6 months in the experimental group, daily hair loss at baseline (52.52 ± 33.98) decreased to 40.41 ± 24.78, vertex hair density at baseline (131.07 ± 43.73) increased to 156.00 ± 39.59, frontal hair density at baseline (104.21 ± 30.72) increased to 124.10 ± 28.28, thickness of vertex hair at baseline (0.067 ± 0.012 cm) increased to 0.075 ± 0.014 cm, thickness of frontal hair at baseline (0.070 ± 0.009 cm) increased to 0.076 ± 0.012 cm, and hair growth rate was 16.17 ± ","[{'ForeName': 'Weon Ju', 'Initials': 'WJ', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Korea.'}, {'ForeName': 'Chihyeon', 'Initials': 'C', 'LastName': 'Sohng', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Korea.'}, {'ForeName': 'Jun Young', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Korea.'}, {'ForeName': 'Kyung Duck', 'Initials': 'KD', 'LastName': 'Park', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Korea.'}, {'ForeName': 'Yong Hyun', 'Initials': 'YH', 'LastName': 'Jang', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Korea.'}, {'ForeName': 'Seok-Jong', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Korea.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13220']
1270,31085503,Procedural microvascular activation in long lesions treated with bioresorbable vascular scaffolds or everolimus-eluting stents: the PROACTIVE trial.,"AIMS


Significant platelet activation after long stented coronary segments has been associated with periprocedural microvascular impairment and myonecrosis. In long lesions treated either with an everolimus-eluting bioresorbable vascular scaffold (BVS) or an everolimus-eluting stent (EES), we aimed to investigate (a) procedure-related microvascular impairment, and (b) the relationship of platelet activation with microvascular function and related myonecrosis.
METHODS AND RESULTS


Patients (n=66) undergoing elective percutaneous coronary intervention (PCI) in long lesions were randomised 1:1 to either BVS or EES. The primary endpoint was the difference between groups in changes of pressure-derived corrected index of microvascular resistance (cIMR) after PCI. Periprocedural myonecrosis was assessed by high-sensitivity cardiac troponin T (hs-cTnT), platelet reactivity by high-sensitivity adenosine diphosphate (hs-ADP)-induced platelet reactivity with the Multiplate Analyzer. Post-dilatation was more frequent in the BVS group, with consequent longer procedure time. A significant difference was observed between the two groups in the primary endpoint of ΔcIMR (p=0.04). hs-ADP was not different between the groups at different time points. hs-cTnT significantly increased after PCI, without difference between the groups.
CONCLUSIONS


In long lesions, BVS implantation is associated with significant acute reduction in IMR as compared with EES, with no significant interaction with platelet reactivity or periprocedural myonecrosis.",2020,"A significant difference was observed between the two groups in the primary endpoint of Δ cIMR (p= 0,04).",['Patients (n=66) undergoing'],"['everolimus-eluting bioresorbable vascular scaffold (BVS) or everolimus-eluting stent (EES', 'bioresorbable vascular scaffold versus everolimus-eluting stent implantation', 'BVS or EES', 'elective percutaneous coronary intervention (PCI']","['changes of pressure-derived corrected index of microvascular resistance (cIMR', 'high sensitivity-cardiac troponin T (hs-cTnT), platelet reactivity', 'microvascular ACTIVation', 'Hs-ADP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0337143', 'cui_str': 'Scaffold, device (physical object)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C3538889', 'cui_str': 'Cardiac troponin T (substance)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0001459', 'cui_str': ""Adenosine 5'-Pyrophosphate""}]",66.0,0.10859,"A significant difference was observed between the two groups in the primary endpoint of Δ cIMR (p= 0,04).","[{'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Pellicano', 'Affiliation': 'Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Di Gioia', 'Affiliation': ''}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Ciccarelli', 'Affiliation': ''}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Xaplanteris', 'Affiliation': ''}, {'ForeName': 'Leen', 'Initials': 'L', 'LastName': 'Delrue', 'Affiliation': ''}, {'ForeName': 'Gabor G', 'Initials': 'GG', 'LastName': 'Toth', 'Affiliation': ''}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Van Durme', 'Affiliation': ''}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Heyse', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Wyffels', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Vanderheyden', 'Affiliation': ''}, {'ForeName': 'Jozef', 'Initials': 'J', 'LastName': 'Bartunek', 'Affiliation': ''}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'De Bruyne', 'Affiliation': ''}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Barbato', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-18-01138']
1271,31740114,Early outcomes with durable left ventricular assist device replacement using the HeartMate 3.,"BACKGROUND


The HeartMate 3 (HM3) left ventricular assist device (LVAD) (Abbott, Inc, Chicago, Ill) is a fully magnetically levitated centrifugal implantable pump used to treat patients with chronic heart failure. The MOMENTUM (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3) trial demonstrated that patients treated with the HM3 experienced reduced need for reoperation for LVAD replacement compared with a control group receiving an axial flow design, Heartmate II (Abbott, Inc). However, there are few reports of using HM3 as the replacement pump in patients who already are supported by a durable LVAD and experience a device-related complication necessitating replacement.
METHODS


An institutional LVAD database was used to identify 19 consecutive patients who underwent pump replacement to HM3 (group 1) versus 85 consecutive control patients who underwent pump replacement to either Heartmate II or HeartWare Ventricular Assist Device (Medtronic Inc, Minneapolis, Minn) (group 2), at a single institution from January 2010 to August 2018. Patient baseline characteristic and outcomes were obtained from a prospectively maintained database. The primary endpoint was a composite of freedom from death or need for another replacement surgery.
RESULTS


There was no difference between the groups in heart failure etiology, indication for replacement, as well as the average days on the previous pump or the type of previous pump. The HM3 group did have a significantly greater body mass index (37 vs 31.6 P = .01), a greater number of previous LVAD implants (36.8% vs 5.9%, had 2 previous LVADs, P < .001), and a greater number of previous sternotomies (31.6% vs 7.1%, had 3 previous sternotomies, P = .001). No difference was found between the groups in terms of postoperative adverse event rates. With regards to the primary endpoint, the patients with HM3 replacements (group 1) versus group 2 experienced significantly greater freedom from either death or need for another replacement during the follow-up period (P = .039). During follow-up, there were no thrombosis events for the patients who received replacement with HM3.
CONCLUSIONS


LVAD replacement with HM3 can be performed safely and may be considered as the pump of choice in patients requiring LVAD replacement.",2020,"The HM3 group did have a significantly greater body mass index (37 vs 31.6 P = .01), a greater number of previous LVAD implants (36.8% vs 5.9%, had 2 previous LVADs, P ","['19 consecutive patients who underwent', 'patients with chronic heart failure', 'group 1) versus 85 consecutive control patients who underwent', 'patients requiring LVAD replacement', 'Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3']","['pump replacement to HM3', 'Ventricular Assist Device', 'durable left ventricular assist device replacement', 'pump replacement to either Heartmate II or HeartWare', 'HeartMate 3 (HM3) left ventricular assist device (LVAD']","['number of previous sternotomies', 'composite of freedom from death or need for another replacement surgery', 'body mass index', 'greater number of previous LVAD implants', 'freedom from either death or need for another replacement', 'thrombosis events', 'postoperative adverse event rates', 'heart failure etiology']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0085842', 'cui_str': 'Artificial Ventricle'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0185792', 'cui_str': 'Sternotomy'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0015127', 'cui_str': 'causes'}]",19.0,0.051187,"The HM3 group did have a significantly greater body mass index (37 vs 31.6 P = .01), a greater number of previous LVAD implants (36.8% vs 5.9%, had 2 previous LVADs, P ","[{'ForeName': 'Yaron D', 'Initials': 'YD', 'LastName': 'Barac', 'Affiliation': 'Division of Cardiothoracic Surgery, Duke University Medical Center, Durham, NC. Electronic address: yaronbar@icloud.com.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Wojnarski', 'Affiliation': 'Division of Cardiothoracic Surgery, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Parichart', 'Initials': 'P', 'LastName': 'Junpaparp', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Oliver K', 'Initials': 'OK', 'LastName': 'Jawitz', 'Affiliation': 'Division of Cardiothoracic Surgery, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Billard', 'Affiliation': 'Division of Cardiothoracic Surgery, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Mani A', 'Initials': 'MA', 'LastName': 'Daneshmand', 'Affiliation': 'Division of Cardiothoracic Surgery, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Richa', 'Initials': 'R', 'LastName': 'Agrawal', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Devore', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Chetan B', 'Initials': 'CB', 'LastName': 'Patel', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Jacob N', 'Initials': 'JN', 'LastName': 'Schroder', 'Affiliation': 'Division of Cardiothoracic Surgery, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Carmelo A', 'Initials': 'CA', 'LastName': 'Milano', 'Affiliation': 'Division of Cardiothoracic Surgery, Duke University Medical Center, Durham, NC.'}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2019.09.151']
1272,31740197,"Different metabolism of EPA, DPA and DHA in humans: A double-blind cross-over study.","This study aimed to compare eicosapentaenoic acid (EPA), docosapentaenoic acid (DPA) and docosahexaenoic acid (DHA) incorporated into red blood cells (RBC) phospholipids (PL), plasma PL, plasma triglyceride (TAG), and plasma cholesteryl ester (CE) fractions, and the metabolomics profiles in a double-blind cross-over study. Twelve female healthy subjects randomly consumed 1 g per day for 6 days of pure EPA, DPA, or DHA. The placebo treatment was olive oil. The fasting venous blood was taken at days 0, 3 and 6, and the RBC PL and plasma lipid fractions were separated for fatty acid determination using thin layer chromatography followed by gas chromatography. Plasma metabolites were analyzed by UHPLC-Q-Exactive Orbitrap/MS. Supplemental EPA significantly increased the concentrations of EPA in RBC PL (days 3 and 6). For subjects consuming the DPA supplement, the concentrations of both DPA and EPA were significantly increased in RBC PL over a 6-day period, respectively. For plasma PL fraction, EPA and DPA supplementation significantly increased the concentrations of EPA and DPA at both days 3 and 6, respectively. Supplemental DHA significantly increased the concentrations of DHA in plasma PL at day 6. For plasma TAG fraction, supplementation with EPA and DPA significantly increased the concentrations of EPA and DPA at both days 3 and 6, respectively. After DHA supplementation, significant increases in the concentrations of DHA were found relative to baseline at both days 3 and 6. For plasma CE fraction, EPA supplementation significantly increased the concentrations of EPA (days 3 and 6) and DPA (days 6), respectively. Supplemental DPA significantly increased the concentrations of EPA at day 6. Meanwhile, the concentrations of DHA were significantly increased over a 6-day period of intervention after subjects consuming the DHA supplements. There were a total of 922 plasma metabolites identified using metabolomics analyses. Supplementation with DPA and DHA significantly increased the levels of sphingosine 1-phosphate (P  for DPA  = 0.025, P  for DHA  = 0.029) and 15-deoxy-Δ12,14-prostaglandin A1 (P  for DPA  = 0.034; P  for DHA  = 0.021) in comparison with olive oil group. Additionally, supplementation with EPA (P = 0.007) and DHA (P = 0.005) significantly reduced the levels of linoleyl carnitine, compared with olive oil group. This study shows that DPA might act as a reservoir of n-3 LCP incorporated into blood lipid fractions, metabolized into DHA, and retro-converted back to EPA. Metabolomics analyses indicate that supplemental EPA, DPA and DHA have shared and differentiated metabolites. The differences of these metabolic biomarkers should be investigated in additional studies.",2020,Supplementation with DPA and DHA significantly increased the levels of sphingosine 1-phosphate,"['Twelve female healthy subjects', 'humans']","['Supplemental EPA', 'randomly consumed 1\xa0g per day for 6 days of pure EPA, DPA, or DHA', 'EPA, DPA and DHA', 'placebo', 'eicosapentaenoic acid (EPA), docosapentaenoic acid (DPA) and docosahexaenoic acid (DHA', 'Supplemental DPA']","['Plasma metabolites', 'concentrations of DHA', 'concentrations of DHA in plasma PL', 'red blood cells (RBC) phospholipids (PL), plasma PL, plasma triglyceride (TAG), and plasma cholesteryl ester (CE) fractions', 'RBC PL', 'concentrations of EPA', 'concentrations of EPA and DPA', 'levels of sphingosine 1-phosphate', 'concentrations of both DPA and EPA', 'concentrations of EPA in RBC PL', 'fasting venous blood', '15-deoxy-Δ12,14-prostaglandin A1', 'levels of linoleyl carnitine']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0058624', 'cui_str': 'docosapentaenoic acid (C22:5 N3)'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0031676', 'cui_str': 'Phospholipids'}, {'cui': 'C0583329', 'cui_str': 'Plasma triglyceride measurement'}, {'cui': 'C0008387', 'cui_str': 'Cholesteryl Esters'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0229667', 'cui_str': 'VB - Venous blood'}, {'cui': 'C0072261', 'cui_str': 'prostaglandin A1'}, {'cui': 'C0696229', 'cui_str': 'Carnitine'}]",12.0,0.117066,Supplementation with DPA and DHA significantly increased the levels of sphingosine 1-phosphate,"[{'ForeName': 'Xiao-Fei', 'Initials': 'XF', 'LastName': 'Guo', 'Affiliation': 'Institute of Nutrition and Health, Qingdao University, Qingdao, China.'}, {'ForeName': 'Wen-Feng', 'Initials': 'WF', 'LastName': 'Tong', 'Affiliation': 'Department of Food Science and Nutrition, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Ruan', 'Affiliation': 'Department of Food Science and Nutrition, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Sinclair', 'Affiliation': 'Faculty of Health, Deakin University, Geelong, Australia; Department of Nutrition, Dietetics and Food, Monash University, Melbourne, Australia.'}, {'ForeName': 'Duo', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Institute of Nutrition and Health, Qingdao University, Qingdao, China; Department of Food Science and Nutrition, Zhejiang University, Hangzhou, China. Electronic address: duoli@qdu.edu.cn.'}]","Prostaglandins, leukotrienes, and essential fatty acids",['10.1016/j.plefa.2019.102033']
1273,31741318,An analysis of the processing of intramodal and intermodal time intervals.,"In this 3-experiment study, the Weber fractions in the 300-ms and 900-ms duration ranges are obtained with 9 types of empty intervals resulting from the combinations of three types of signals for marking the beginning and end of the signals: auditory (A), visual (V), or tactile (T). There were three types of intramodal intervals (AA, TT, and VV) and 6 types of intermodal intervals (AT, AV, VA, VT, TA, and TV). The second marker is always the same during Experiments 1 (A), 2 (V), and 3 (T). With an uncertainty strategy where the first marker is 1 of 2 sensory signals being presented randomly from trial to trial, the study provides direct comparisons of the perceived length of the different marker-type intervals. The results reveal that the Weber fraction is nearly constant in the three types of intramodal intervals, but is clearly lower at 900 ms than at 300 ms in intermodal conditions. In several cases, the intramodal intervals are perceived as shorter than intermodal intervals, which is interpreted as an effect of the efficiency in detecting the second marker of an intramodal interval. There were no significant differences between the TA and VA intervals (Experiment 1) and between the AV and TV intervals (Experiment 2), but in Experiment 3, the AT intervals were perceived as longer than the VT intervals. The results are interpreted in terms of the generalized form of Weber's law, using the properties of the signals for explaining the additional nontemporal noise observed in the intermodal conditions.",2020,"There were no significant differences between the TA and VA intervals (Experiment 1) and between the AV and TV intervals (Experiment 2), but in Experiment 3, the AT intervals were perceived as longer than the VT intervals.",[],[],"['signals: auditory (A), visual (V), or tactile (T', 'intramodal intervals (AA, TT, and VV) and 6 types of intermodal intervals (AT, AV, VA, VT, TA, and TV']",[],[],"[{'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0439815', 'cui_str': 'Tactile (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",,0.0237555,"There were no significant differences between the TA and VA intervals (Experiment 1) and between the AV and TV intervals (Experiment 2), but in Experiment 3, the AT intervals were perceived as longer than the VT intervals.","[{'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Azari', 'Affiliation': 'École de Psychologie, Université Laval, 2325 rue des Bibliothèques, Québec, G1V 0A6, Canada.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Mioni', 'Affiliation': 'Dipartimento di Psicologia Generale, Università di Padova, Padova, Italy.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Rousseau', 'Affiliation': 'École de Psychologie, Université Laval, 2325 rue des Bibliothèques, Québec, G1V 0A6, Canada.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Grondin', 'Affiliation': 'École de Psychologie, Université Laval, 2325 rue des Bibliothèques, Québec, G1V 0A6, Canada. simon.grondin@psy.ulaval.ca.'}]","Attention, perception & psychophysics",['10.3758/s13414-019-01900-7']
1274,31669966,"The effects of training with simulation on knowledge, skill and anxiety levels of the nursing students in terms of cardiac auscultation: A randomized controlled study.","BACKGROUND


The use of simulation methods in nursing education is important in terms of decreasing anxiety of students in a safe and realistic environment due to the improvement of knowledge and skills of students in terms of cardiac auscultation and their attitudes to prepare for clinical applications.
OBJECTIVES


The aim of this study is to compare the effectiveness of high-fidelity simulator and traditional teaching method on nursing students' knowledge and skill development in terms of cardiac auscultation and their anxiety levels.
DESIGN


Randomized controlled study.
SETTING


The study was conducted in the simulation laboratory of the Nursing Department in the Health College and in the inpatient clinics of the Medicine Faculty Hospital.
PARTICIPANTS


72 first-year nursing students (simulation group = 36, control group = 36).
METHODS


The students were randomly distributed to the simulation and control groups. The students in the simulation group received a cardiac auscultation training by using a high-fidelity simulator while the students in the control group received training with the traditional teaching method. After the training sessions, all students practiced their skills in the laboratory and on real patients in clinical setting under the supervision of the researcher. The data were collected by using the Demographic Information Form, Knowledge Assessment Form for Cardiac Auscultation, Skill Evaluation Form for Cardiac Auscultation and State Anxiety Inventory (SAI).
RESULTS


High-fidelity simulators and traditional teaching method were found to be effective in increasing the students' knowledge and skill levels in terms of cardiac auscultation. However, it was found that the high-fidelity simulator method was more effective than the traditional teaching method to increase the students' knowledge (p = 0.001) and skill (p < 0.001) levels; this increase was significant. In addition, it was found that the students in the high-fidelity simulator group showed a significant decrease in anxiety scores compared to the students who were trained with traditional education method (p < 0.001).
CONCLUSIONS


The results showed that the use of high-fidelity simulator in nursing education was more effective than traditional method in terms of improving the students' knowledge, skill levels for cardiac auscultation and reducing their anxiety.",2020,"RESULTS


High-fidelity simulators and traditional teaching method were found to be effective in increasing the students' knowledge and skill levels in terms of cardiac auscultation.","['72 first-year nursing students (simulation group\u202f=\u202f36, control group\u202f=\u202f36', 'Nursing Department in the Health College and in the inpatient clinics of the Medicine Faculty Hospital', 'nursing students in terms of cardiac auscultation']","['high-fidelity simulator and traditional teaching method', 'cardiac auscultation training by using a high-fidelity simulator while the students in the control group received training with the traditional teaching method']","[""students' knowledge"", 'anxiety scores', ""students' knowledge, skill levels for cardiac auscultation and reducing their anxiety"", 'knowledge, skill and anxiety levels', 'Demographic Information Form, Knowledge Assessment Form for Cardiac Auscultation, Skill Evaluation Form for Cardiac Auscultation and State Anxiety Inventory (SAI']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0018793', 'cui_str': 'Cardiac Auscultation'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0039403', 'cui_str': 'Teaching Methods'}, {'cui': 'C0018793', 'cui_str': 'Cardiac Auscultation'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0018793', 'cui_str': 'Cardiac Auscultation'}, {'cui': 'C0150135', 'cui_str': 'Reducing anxiety'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",,0.0254689,"RESULTS


High-fidelity simulators and traditional teaching method were found to be effective in increasing the students' knowledge and skill levels in terms of cardiac auscultation.","[{'ForeName': 'Birgul', 'Initials': 'B', 'LastName': 'Vural Doğru', 'Affiliation': 'Mersin University, Faculty of Nursing, Department of Medical Nursing, 33110 Mersin, Turkey. Electronic address: bvuraldogru@gmail.com.'}, {'ForeName': 'Leyla', 'Initials': 'L', 'LastName': 'Zengin Aydın', 'Affiliation': 'Dicle University, Department of Nursing, 21280 Diyarbakır, Turkey.'}]",Nurse education today,['10.1016/j.nedt.2019.104216']
1275,31683132,Effectiveness of music therapy and progressive muscle relaxation in reducing stress before exams and improving academic performance in Nursing students: A randomized trial.,"BACKGROUND


Nursing students experiencing high stress levels before exams could suffer worse academic performance.
OBJECTIVE


We evaluated an intervention combining Progressive Muscle Relaxation (PMR) and music therapy on the decrease of before exams stress and the improvement of academic results.
DESIGN AND METHODS


Randomized controlled trial including students from the Nursing Degree during the first semester of the 2017-2018 academic year. All participants were randomized to the control (CG) or the experimental group (EG). The CG took the exam as usual whereas in the EG, PMR and music therapy were performed before exams. Blood samples were drawn to investigate variations in biochemical parameters. The academic performance was assessed by the score obtained in the ""Clinical Nursing"" exam.
RESULTS


We included 112 students (75% females, mean age 24.3 ± 6.2 years, 56 students in every group). There were no differences in any parameter during the first measurement. Regarding the second measurement, we observed a reduction in heart rate for the EG and an increase in blood pressure, heart rate, and cortisol for the CG. Indeed, these parameters were significantly higher compared to the EG. The EG had a mean score of 5.07 ± 1.59 in the Clinical Nursing exam, which was significantly higher compared to the CG (4.42 ± 1.58, p = 0.033). The proportion of fails in the CG was also higher (62.5% vs. 42.9%, p = 0.037).
CONCLUSION


In this study including students from the Nursing degree, the combination of PMR and music therapy was effective for the control and decrease of stress before exams, and also demonstrated improvements in academic results.",2020,"The proportion of fails in the CG was also higher (62.5% vs. 42.9%, p = 0.037).
","['Nursing students', '112 students (75% females, mean age 24.3\u202f±\u202f6.2\u202fyears, 56 students in every group', 'students from the Nursing Degree during the first semester of the 2017-2018 academic year']","['intervention combining Progressive Muscle Relaxation (PMR) and music therapy', 'music therapy and progressive muscle relaxation']","['academic performance', 'heart rate', 'blood pressure, heart rate, and cortisol for the CG', 'proportion of fails in the CG']","[{'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0004361', 'cui_str': 'Progressive Relaxation'}, {'cui': 'C0026868', 'cui_str': 'Music Therapy'}]","[{'cui': 'C0036373', 'cui_str': 'Academic Performance'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]",,0.0163263,"The proportion of fails in the CG was also higher (62.5% vs. 42.9%, p = 0.037).
","[{'ForeName': 'Juana Inés', 'Initials': 'JI', 'LastName': 'Gallego-Gómez', 'Affiliation': 'Faculty of Nursing, Catholic University of Murcia (UCAM), Murcia, Spain.'}, {'ForeName': 'Serafín', 'Initials': 'S', 'LastName': 'Balanza', 'Affiliation': 'Faculty of Nursing, Catholic University of Murcia (UCAM), Murcia, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Leal-Llopis', 'Affiliation': 'Faculty of Nursing, Catholic University of Murcia (UCAM), Murcia, Spain.'}, {'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'García-Méndez', 'Affiliation': 'Faculty of Nursing, Catholic University of Murcia (UCAM), Murcia, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Oliva-Pérez', 'Affiliation': 'Faculty of Nursing, Catholic University of Murcia (UCAM), Murcia, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Doménech-Tortosa', 'Affiliation': 'Faculty of Nursing, Catholic University of Murcia (UCAM), Murcia, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Gómez-Gallego', 'Affiliation': 'Faculty of Nursing, Catholic University of Murcia (UCAM), Murcia, Spain.'}, {'ForeName': 'Agustín Javier', 'Initials': 'AJ', 'LastName': 'Simonelli-Muñoz', 'Affiliation': 'Faculty of Nursing, Catholic University of Murcia (UCAM), Murcia, Spain. Electronic address: agsimonelli@ucam.edu.'}, {'ForeName': 'José Miguel', 'Initials': 'JM', 'LastName': 'Rivera-Caravaca', 'Affiliation': 'Faculty of Nursing, Catholic University of Murcia (UCAM), Murcia, Spain; Department of Cardiology, Hospital Clínico Universitario Virgen de la Arrixaca, Instituto Murciano de Investigación Biosanitaria (IMIB-Arrixaca), CIBERCV, Murcia, Spain.'}]",Nurse education today,['10.1016/j.nedt.2019.104217']
1276,31741252,Vibrator-Assisted Start-Stop Exercises Improve Premature Ejaculation Symptoms: A Randomized Controlled Trial.,"Premature ejaculation (PE) is associated with decreased quality of life, lower confidence and self-esteem, and higher levels of depression, anxiety, and interpersonal difficulties. Here we investigated the effectiveness of vibrator-assisted start-stop exercises for treatment of PE, and whether the treatment effect could be enhanced by an additional psychobehavioral intervention. Fifty participants with a mean age of 41.7 years were included and randomized into two treatment groups and a waiting list control group. Participants were instructed to perform start-stop exercises while stimulating the penis with a purpose-made vibrator, 3 times a week for 6 weeks. Additionally, participants in one of the treatment groups received additional psychoeducation and performed mindfulness meditation-based body scan exercises three times a week. Data were gathered through online questionnaires before and after treatment, as well as 3 and 6 months after treatment. The interventions reduced PE symptoms with large effect sizes (partial η 2  = .20 across the three groups, d [95% CI] = 1.05 [.27, 1.82] and 1.07 [.32, 1.82] for treatment groups compared to waiting list control group). The additional psychobehavioral intervention did not further reduce PE symptoms, but did decrease PE-associated negative symptoms such as levels of sexual distress, anxiety, and depression. No side effects were reported. Vibrator-assisted start-stop exercises can be offered as an adequate treatment option for PE.",2020,"The interventions reduced PE symptoms with large effect sizes (partial η 2  = .20 across the three groups, d [95% CI] = 1.05 [.27, 1.82] and 1.07 [.32, 1.82] for treatment groups compared to waiting list control group).",['Fifty participants with a mean age of 41.7\xa0years'],"['Vibrator-Assisted Start-Stop Exercises', 'waiting list control group', 'additional psychoeducation and performed mindfulness meditation-based body scan exercises three times a week', 'vibrator-assisted start-stop exercises', 'Vibrator-assisted start-stop exercises']","['Premature Ejaculation Symptoms', 'Premature ejaculation (PE', 'sexual distress, anxiety, and depression', 'PE symptoms', 'quality of life, lower confidence and self-esteem, and higher levels of depression, anxiety, and interpersonal difficulties']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0184304', 'cui_str': 'Vibrator, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0150277'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0441633'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0033038', 'cui_str': 'Ejaculatio Praecox'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0034380'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",50.0,0.0493297,"The interventions reduced PE symptoms with large effect sizes (partial η 2  = .20 across the three groups, d [95% CI] = 1.05 [.27, 1.82] and 1.07 [.32, 1.82] for treatment groups compared to waiting list control group).","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ventus', 'Affiliation': 'Department of Psychology, Åbo Akademi University, Fabriksgatan 2, 20500, Turku, Finland. dventus@abo.fi.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Gunst', 'Affiliation': 'Department of Psychology, University of Turku, Turku, Finland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Arver', 'Affiliation': 'Anova, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Dhejne', 'Affiliation': 'Anova, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Katarina G', 'Initials': 'KG', 'LastName': 'Öberg', 'Affiliation': 'Anova, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Zamore-Söderström', 'Affiliation': 'Anova, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Kärnä', 'Affiliation': ', Turku, Finland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Jern', 'Affiliation': 'Department of Psychology, Åbo Akademi University, Fabriksgatan 2, 20500, Turku, Finland.'}]",Archives of sexual behavior,['10.1007/s10508-019-01520-0']
1277,31070690,"Sorafenib Plus Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, and Leucovorin vs Sorafenib Alone for Hepatocellular Carcinoma With Portal Vein Invasion: A Randomized Clinical Trial.","Importance


Sorafenib is the first-line treatment for hepatocellular carcinoma with portal vein invasion; however, it has shown unsatisfactory survival benefit. Sorafenib plus hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, fluorouracil, and leucovorin (FOLFOX) has shown promising results for these patients in a previous phase 2 study.
Objective


To investigate the efficacy and safety of sorafenib plus HAIC compared with sorafenib for hepatocellular carcinoma with portal vein invasion.
Design, Setting, and Participants


This randomized, open-label clinical trial enrolled 818 screened patients. Of the 818 participants, 247 with hepatocellular carcinoma and portal vein invasion were randomly assigned (1:1) via a computer-generated sequence to receive sorafenib plus HAIC or sorafenib. This trial was conducted at 5 hospitals in China and enrolled patients from April 1, 2016, to October 10, 2017, with a follow-up period of 10 months.
Interventions


Randomization to receive 400 mg sorafenib twice daily (sorafenib group) or 400 mg sorafenib twice daily plus HAIC (SoraHAIC group) (oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, fluorouracil bolus 400 mg/m2 on day 1, and fluorouracil infusion 2400 mg/m2 for 46 hours, every 3 weeks).
Main Outcomes and Measures


The primary endpoint was overall survival by intention-to-treat analysis. Safety was assessed in patients who received at least 1 dose of study treatment.
Results


For 247 patients (median age, 49 years; range, 18-75 years; 223 men and 24 women), median overall survival was 13.37 months (95% CI, 10.27-16.46) in the SoraHAIC group vs 7.13 months (95% CI, 6.28-7.98) in the sorafenib group (hazard ratio [HR], 0.35; 95% CI, 0.26-0.48; P < .001). The SoraHAIC group showed a higher response rate than the sorafenib group (51 [40.8%] vs 3 [2.46%]; P < .001), and a longer median progression-free survival (7.03 [95% CI, 6.05-8.02] vs 2.6 [95% CI, 2.15-3.05] months; P < .001). Grade 3/4 adverse events that were more frequent in the SoraHAIC group than in the sorafenib group included neutropenia (12 [9.68%] vs 3 [2.48%]), thrombocytopenia (16 [12.9%] vs 6 [4.96%]), and vomiting (8 [6.45%] vs 1 [0.83%]).
Conclusions and Relevance


Sorafenib plus HAIC of FOLFOX improved overall survival and had acceptable toxic effects compared with sorafenib in patients with hepatocellular carcinoma and portal vein invasion.
Trial Registration


ClinicalTrials.gov identifier: NCT02774187.",2019,"Conclusions and Relevance


Sorafenib plus HAIC of FOLFOX improved overall survival and had acceptable toxic effects compared with sorafenib in patients with hepatocellular carcinoma and portal vein invasion.
","['247 patients (median age, 49 years; range, 18-75 years; 223 men and 24 women', '818 participants, 247 with hepatocellular carcinoma and portal vein invasion', 'patients with hepatocellular carcinoma and portal vein invasion', 'Hepatocellular Carcinoma', 'hepatocellular carcinoma with portal vein invasion', '5 hospitals in China and enrolled patients from April 1, 2016, to October 10, 2017, with a follow-up period of 10 months', '818 screened patients']","['Oxaliplatin, Fluorouracil, and Leucovorin vs Sorafenib Alone', 'Portal Vein Invasion', 'Sorafenib', 'sorafenib twice daily (sorafenib group) or 400 mg sorafenib twice daily plus HAIC (SoraHAIC group', 'FOLFOX', 'Sorafenib plus hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, fluorouracil, and leucovorin (FOLFOX', 'oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, fluorouracil bolus 400 mg/m2 on day 1, and fluorouracil', 'sorafenib plus HAIC', 'sorafenib', 'sorafenib plus HAIC or sorafenib']","['vomiting', 'longer median progression-free survival', 'thrombocytopenia', 'overall survival by intention-to-treat analysis', 'neutropenia', 'response rate', 'median overall survival', 'Grade 3/4 adverse events', 'overall survival', 'efficacy and safety', 'Safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0032718', 'cui_str': 'Portal Vein'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0032718', 'cui_str': 'Portal Vein'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4304118', 'cui_str': 'Hepatic arterial infusion chemotherapy (procedure)'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",818.0,0.337979,"Conclusions and Relevance


Sorafenib plus HAIC of FOLFOX improved overall survival and had acceptable toxic effects compared with sorafenib in patients with hepatocellular carcinoma and portal vein invasion.
","[{'ForeName': 'MinKe', 'Initials': 'M', 'LastName': 'He', 'Affiliation': 'Department of Hepatobiliary Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'QiJiong', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Hepatobiliary Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'RuHai', 'Initials': 'R', 'LastName': 'Zou', 'Affiliation': 'Department of Ultrasonography, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'JingXian', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': 'Department of Radiology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'WanQiang', 'Initials': 'W', 'LastName': 'Fang', 'Affiliation': 'Kaiping Central Hospital, KaiPing, China.'}, {'ForeName': 'GuoSheng', 'Initials': 'G', 'LastName': 'Tan', 'Affiliation': 'First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'YuanMin', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ""Guangzhou No.12 People's Hospital, Guangzhou, China.""}, {'ForeName': 'XiaoPing', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'The First Affiliated Hospital of the University of South China, HengYang, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Hepatobiliary Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wei', 'Affiliation': 'Department of Hepatobiliary Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Le', 'Affiliation': 'Department of Hepatobiliary Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'ZhongGuo', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Hepatobiliary Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Minimally Invasive Interventional Division, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Clinical Research, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'RongPing', 'Initials': 'R', 'LastName': 'Guo', 'Affiliation': 'Department of Hepatobiliary Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'MinShan', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Department of Hepatobiliary Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Shi', 'Affiliation': 'Department of Hepatobiliary Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}]",JAMA oncology,['10.1001/jamaoncol.2019.0250']
1278,31067489,Mnemonic strategy training increases neocortical activation in healthy older adults and patients with mild cognitive impairment.,"Learning and memory deficits characterize the diagnosis of amnestic mild cognitive impairment (aMCI), which is widely viewed as a clinical precursor to Alzheimer's type dementia. There is a growing interest in non-pharmacologic interventions, such as mnemonic strategies, for improving learning and memory in patients with aMCI as well as for maintaining functioning in healthy older adults. Using an ecologically relevant object-location association paradigm, we conducted a randomized, controlled, single-blind study in which healthy older adults and patients with aMCI were randomized to either mnemonic strategy training or a control group that was matched for stimulus exposure. We previously reported that mnemonic strategy training resulted in significantly greater learning and memory improvements compared to the matched exposure condition, in both aMCI patients and healthy controls. The current study examined changes in neocortical activation during encoding in a subset of participants who underwent functional magnetic resonance imaging (fMRI) scanning both before and after training. To minimize potential confounds in between-group comparisons, we employed non-linear cortex based alignment and included only correctly encoded stimuli in our analyses. When re-encoding stimuli learned during training (i.e., trained stimuli), we found a general enhancement of activation in right prefrontal and parietal regions, possibly reflecting practice-related improvement in coordinate spatial processing in all but the aMCI exposure group. Left hemisphere activation was typically only evident in the mnemonic strategy trained participants, regardless of diagnostic status, with the ventrolateral prefrontal cortex appearing especially important for strategy use. While encoding relatively novel stimuli, both mnemonic strategy groups (aMCI patients and healthy controls) demonstrated increased activation in a subset of regions showing change for the trained stimuli, indicating a mnemonic strategy-induced change in the processing of new information. These findings could not be explained by repeated exposure since there was little to no activation overlap in the respective exposure control groups. The current results reinforce the potential benefits of cognitive interventions in these growing populations and indicate that neuroplastic change in key rostral and lateral prefrontal regions mediate this behavioral change.",2020,"There is a growing interest in non-pharmacologic interventions, such as mnemonic strategies, for improving learning and memory in patients with aMCI as well as for maintaining functioning in healthy older adults.","['amnestic mild cognitive impairment (aMCI', 'healthy older adults and patients with mild cognitive impairment', 'healthy older adults', 'healthy older adults and patients with aMCI']","['mnemonic strategy training', 'Mnemonic strategy training', 'functional magnetic resonance imaging (fMRI) scanning']","['neocortical activation', 'learning and memory improvements', 'Left hemisphere activation']","[{'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0589105', 'cui_str': 'Strategy training (regime/therapy)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0025260', 'cui_str': 'Memory'}]",,0.0213011,"There is a growing interest in non-pharmacologic interventions, such as mnemonic strategies, for improving learning and memory in patients with aMCI as well as for maintaining functioning in healthy older adults.","[{'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Hampstead', 'Affiliation': 'Mental Health Service, VA Ann Arbor Healthcare System, Ann Arbor, MI, United States of America; Neuropsychology Section, Department of Psychiatry, University of Michigan, Ann Arbor, MI, United States of America; Department of Rehabilitation Medicine, Emory University, Atlanta, GA, United States of America. Electronic address: bhampste@med.umich.edu.'}, {'ForeName': 'Anthony Y', 'Initials': 'AY', 'LastName': 'Stringer', 'Affiliation': 'Department of Rehabilitation Medicine, Emory University, Atlanta, GA, United States of America; Department of Psychology, Emory University, Atlanta, GA, United States of America.'}, {'ForeName': 'Randall F', 'Initials': 'RF', 'LastName': 'Stilla', 'Affiliation': 'Department of Neurology, Emory University, Atlanta, GA, United States of America.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Sathian', 'Affiliation': 'Department of Rehabilitation Medicine, Emory University, Atlanta, GA, United States of America; Department of Neurology, Emory University, Atlanta, GA, United States of America; Department of Psychology, Emory University, Atlanta, GA, United States of America; Departments of Neurology, Neural & Behavioral Sciences, and Psychology, Pennsylvania State University, Hershey, PA, United States of America.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2019.04.011']
1279,31078459,"Two-view digital breast tomosynthesis versus digital mammography in a population-based breast cancer screening programme (To-Be): a randomised, controlled trial.","BACKGROUND


Digital breast tomosynthesis is an advancement of mammography, and has the potential to overcome limitations of standard digital mammography. This study aimed to compare first-generation digital breast tomo-synthesis including two-dimensional (2D) synthetic mammograms versus digital mammography in a population-based screening programme.
METHODS


BreastScreen Norway offers all women aged 50-69 years two-view (craniocaudal and mediolateral oblique) mammographic screening every 2 years and does independent double reading with consensus. We asked all 32 976 women who attended the programme in Bergen in 2016-17, to participate in this randomised, controlled trial with a parallel group design. A study-specific software was developed to allocate women to either digital breast tomosynthesis or digital mammography using a 1:1 simple randomisation method based on participants' unique national identity numbers. The interviewing radiographer did the randomisation by entering the number into the software. Randomisation was done after consent and was therefore concealed from both the women and the radiographer at the time of consent; the algorithm was not disclosed to radiographers during the recruitment period. All data needed for analyses were complete 12 months after the recruitment period ended. The primary outcome measure was screen-detected breast cancer, stratified by screening technique (ie, digital breast tomosynthesis and digital mammography). A log-binomial regression model was used to estimate the efficacy of digital breast tomosynthesis versus digital mammography, defined as the crude risk ratios (RRs) with 95% CIs for screen-detected breast cancer for women screened during the recruitment period. A per-protocol approach was used in the analyses. This trial is registered at ClinicalTrials.gov, number NCT02835625, and is closed to accrual.
FINDINGS


Between, Jan 14, 2016, and Dec 31, 2017, 44 266 women were invited to the screening programme in Bergen, and 32 976 (74·5%) attended. After excluding women with breast implants and women who did not consent to participate, 29 453 (89·3%) were eligible for electronic randomisation. 14 734 women were allocated to digital breast tomosynthesis and 14 719 to digital mammography. After randomisation, women with a previous breast cancer were excluded (digital breast tomosynthesis group n=314, digital mammography group n=316), women with metastases from melanoma (digital breast tomosynthesis group n=1), and women who informed the radiographer about breast symptoms after providing consent (digital breast tomosynthesis group n=39, digital mammography group n=34). After exclusions, information from 28 749 women were included in the analyses (digital breast tomosynthesis group n=14 380, digital mammography group n=14 369). The proportion of screen-detected breast cancer among the screened women did not differ between the two groups (95 [0·66%, 0·53-0·79] of 14 380 vs 87 [0·61%, 0·48-0·73] of 14 369; RR 1·09, 95% CI 0·82-1·46; p=0·56).
INTERPRETATION


This study indicated that digital breast tomosynthesis including synthetic 2D mammograms was not significantly different from standard digital mammography as a screening tool for the detection of breast cancer in a population-based screening programme. Economic analyses and follow-up studies on interval and consecutive round screen-detected breast cancers are needed to better understand the effect of digital breast tomosynthesis in population-based breast cancer screening.
FUNDING


Cancer Registry of Norway, Department of Radiology at Haukeland University Hospital, University of Oslo, and Research Council of Norway.",2019,This study indicated that digital breast tomosynthesis including synthetic 2D mammograms was not significantly different from standard digital mammography as a screening tool for the detection of breast cancer in a population-based screening programme.,"['Between, Jan 14, 2016, and Dec 31, 2017, 44\u2008266 women were invited to the screening programme in Bergen, and 32\u2008976 (74·5%) attended', '14\u2008734 women', 'After exclusions, information from 28\u2008749 women were included in the analyses (digital breast tomosynthesis group n=14\u2008380, digital mammography group n=14\u2008369', 'women with breast implants and women who did not consent to participate, 29\u2008453 (89·3%) were eligible for electronic randomisation', 'women with a previous breast cancer were excluded (digital breast tomosynthesis group n=314, digital mammography group n=316), women with metastases from melanoma (digital breast tomosynthesis group n=1), and women who informed the radiographer about breast symptoms after providing consent (digital breast tomosynthesis group n=39, digital mammography group n=34', '32\u2008976 women who attended the programme in Bergen in 2016-17', 'BreastScreen Norway offers all women aged 50-69 years two-view (craniocaudal and mediolateral oblique) mammographic screening every 2 years and does independent double reading with consensus']","['digital breast tomosynthesis or digital mammography', 'digital breast tomosynthesis and 14\u2008719 to digital mammography', 'Two-view digital breast tomosynthesis versus digital mammography', 'generation digital breast tomo-synthesis including two-dimensional (2D) synthetic mammograms versus digital mammography', 'standard digital mammography']","['proportion of screen-detected breast cancer', 'screen-detected breast cancer, stratified by screening technique (ie, digital breast tomosynthesis and digital mammography']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C3472347', 'cui_str': 'Breast Tomosyntheses, X-ray'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319693', 'cui_str': 'Three hundred and eighty'}, {'cui': 'C0860950', 'cui_str': 'Digital Mammography'}, {'cui': 'C0179412', 'cui_str': 'Breast Prosthesis, Internal'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}, {'cui': 'C0402007', 'cui_str': 'Medical radiographer (occupation)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral (qualifier value)'}, {'cui': 'C0205315', 'cui_str': 'Oblique (qualifier value)'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}]","[{'cui': 'C3472347', 'cui_str': 'Breast Tomosyntheses, X-ray'}, {'cui': 'C0860950', 'cui_str': 'Digital Mammography'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C3472347', 'cui_str': 'Breast Tomosyntheses, X-ray'}, {'cui': 'C0860950', 'cui_str': 'Digital Mammography'}]",44266.0,0.0863837,This study indicated that digital breast tomosynthesis including synthetic 2D mammograms was not significantly different from standard digital mammography as a screening tool for the detection of breast cancer in a population-based screening programme.,"[{'ForeName': 'Solveig', 'Initials': 'S', 'LastName': 'Hofvind', 'Affiliation': 'Department of Breast Screening, Cancer Registry of Norway, Oslo, Norway; Faculty of of Health Sciences, Oslo Metropolitan University, Oslo, Norway. Electronic address: solveig.hofvind@kreftregisteret.no.'}, {'ForeName': 'Åsne S', 'Initials': 'ÅS', 'LastName': 'Holen', 'Affiliation': 'Department of Breast Screening, Cancer Registry of Norway, Oslo, Norway.'}, {'ForeName': 'Hildegunn S', 'Initials': 'HS', 'LastName': 'Aase', 'Affiliation': 'Department of Radiology, Haukeland University Hospital, Bergen, Norway; Deparment of Clinical Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Nehmat', 'Initials': 'N', 'LastName': 'Houssami', 'Affiliation': 'Faculty of Medicine and Health, Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Sebuødegård', 'Affiliation': 'Department of Breast Screening, Cancer Registry of Norway, Oslo, Norway.'}, {'ForeName': 'Tron A', 'Initials': 'TA', 'LastName': 'Moger', 'Affiliation': 'Department of Health Management and Health Economics, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Ingfrid S', 'Initials': 'IS', 'LastName': 'Haldorsen', 'Affiliation': 'Department of Radiology, Haukeland University Hospital, Bergen, Norway; Deparment of Clinical Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Lars A', 'Initials': 'LA', 'LastName': 'Akslen', 'Affiliation': 'Department of Pathology, Haukeland University Hospital, Bergen, Norway; Centre for Cancer Biomarkers, Haukeland University Hospital, Bergen, Norway; Deparment of Clinical Medicine, University of Bergen, Bergen, Norway.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30161-5']
1280,31068063,Remote neuropsychological assessment of elderly Japanese population using the Alzheimer's Disease Assessment Scale: A validation study.,"INTRODUCTION


Studies have demonstrated the high agreement of several remote neuropsychological tests using video teleconferencing (VTC) with face-to-face (FTF) tests. However, the reliability of the remotely administered Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog), one of the most commonly used neuropsychological tests to detect cognitive decline, has not been substantially elucidated, particularly in Japanese populations. Therefore, this study aimed to evaluate the reliability of the remotely administered ADAS-cog compared with FTF-administered ADAS-cog among elderly Japanese participants.
METHODS


Participants aged ≥60 years with and without cognitive impairment, i.e. those with mild cognitive impairment (MCI), those with dementia and healthy controls (HCs), were assessed with the ADAS-cog using VTC and FTF testing at an interval of >2 weeks and <3 months. The assessment order (VTC or FTF) was randomized by participants. Participants' scores were compared among the entire sample, as well as subgroups, using intra-class correlation coefficients (ICCs) in a mixed-effects model.
RESULTS


A total of 73 participants were included in the study (36 men; age, 76.3 ± 7.6 years). The ICC for the ADAS-cog total score was high in the entire sample (0.86), whereas ICCs were moderate to high for the subgroups (MCI: 0.63, dementia: 0.80 and HC: 0.74).
DISCUSSION


The results indicate that a VTC-administered ADAS-cog could be an alternative for an FTF-administered ADAS-cog, although further replication studies with larger sample sizes and a wider range of cognitive functionalities are warranted.",2019,"The ICC for the ADAS-cog total score was high in the entire sample (0.86), whereas ICCs were moderate to high for the subgroups (MCI: 0.63, dementia: 0.80 and HC: 0.74).
","[""elderly Japanese population using the Alzheimer's Disease Assessment Scale"", 'A total of 73 participants were included in the study (36 men; age, 76.3\u2009±\u20097.6 years', 'Participants aged ≥60 years with and without cognitive impairment, i.e. those with mild cognitive impairment (MCI), those with dementia and healthy controls (HCs), were assessed with the ADAS-cog using VTC and FTF testing at an interval of >2 weeks and <3 months', 'elderly Japanese participants']","['FTF-administered ADAS-cog', 'video teleconferencing (VTC']",['ADAS-cog total score'],"[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's disease assessment scale (assessment scale)""}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",73.0,0.059487,"The ICC for the ADAS-cog total score was high in the entire sample (0.86), whereas ICCs were moderate to high for the subgroups (MCI: 0.63, dementia: 0.80 and HC: 0.74).
","[{'ForeName': 'Kazunari', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Yamaoka', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Eguchi', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sato', 'Affiliation': 'Center for Outcomes Research and Economic Evaluation for Health, National Institute of Public Health, Saitama, Japan.'}, {'ForeName': 'Kiyoko', 'Initials': 'K', 'LastName': 'Iiboshi', 'Affiliation': 'Department of Clinical Psychology, Faculty of Human Relations, Shigakukan University, Kagoshima, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Kishimoto', 'Affiliation': 'Hoshi Hospital, Fukushima, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Mimura', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Taishiro', 'Initials': 'T', 'LastName': 'Kishimoto', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19845278']
1281,31634752,Resistance training in patients with schizophrenia: Concept and proof of principle trial.,"Resistance training has been shown to contribute to the prevention and management of cardiovascular diseases, which is why it can help reducing morbidity and mortality in schizophrenia patients. Moreover, positive effects on different schizophrenia symptom domains have been proposed. However, a specific resistance training tailored to the needs of schizophrenia patients and its evaluation is still lacking. The objective in this proof of principle trial was to evaluate the feasibility and efficacy of a newly developed 12-week resistance program according to current recommendations of the WHO and the American College of Sports Medicine. We employed a single blind, parallel assignment clinical trial design with participants randomized to attend either a resistance training including three 50min units per week or a balance and tone program as control condition. The primary outcome was the impact on health-related difficulties assessed with the World Health Organization Disability Assessment Schedule (WHO-DAS). Secondary outcome parameters included the level of functioning, schizophrenia symptoms, selected cognitive parameters as well as risk factors for cardiovascular diseases. In our proof of principle trial, we could not find significant time or group effects of resistance training on the WHO-DAS. However, we could observe significant positive effects on the level of functioning assessed with the Global Assessment of Functioning Scale (GAF) over the course of time, which were more pronounced in the intervention group. Our findings indicated that patients with schizophrenia could safely participate in resistance training with relevant improvements in their level of functioning. Well-powered replication trials are needed to provide more efficacy data.",2020,"In our proof of principle trial, we could not find significant time or group effects of resistance training on the WHO-DAS.","['schizophrenia patients', 'patients with schizophrenia', 'WHO and the American College of Sports Medicine']","['Resistance training', 'resistance training', 'resistance training including three 50min units per week or a balance and tone program']","['level of functioning, schizophrenia symptoms, selected cognitive parameters as well as risk factors for cardiovascular diseases', 'health-related difficulties assessed with the World Health Organization Disability Assessment Schedule (WHO-DAS', 'Global Assessment of Functioning Scale (GAF', 'feasibility and efficacy']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0451124', 'cui_str': 'Disability assessment schedule (assessment scale)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0222045'}]",,0.051144,"In our proof of principle trial, we could not find significant time or group effects of resistance training on the WHO-DAS.","[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Maurus', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Munich, Germany. Electronic address: Isabel.Maurus@med.uni-muenchen.de.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mantel', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Keller-Varady', 'Affiliation': 'Hannover Medical School, Institute of Sports Medicine, Hannover, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Schmitt', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Munich, Germany; Laboratory of Neuroscience (LIM27), Institute of Psychiatry, University of Sao Paulo, São Paulo, Brazil.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lembeck', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Röh', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Papazova', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Falkai', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Schneider-Axmann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hasan', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Malchow', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Jena, Jena, Germany.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2019.09.015']
1282,31076365,"Trebananib or placebo plus carboplatin and paclitaxel as first-line treatment for advanced ovarian cancer (TRINOVA-3/ENGOT-ov2/GOG-3001): a randomised, double-blind, phase 3 trial.","BACKGROUND


Angiopoietin 1 and 2 regulate angiogenesis and vascular remodelling by interacting with the tyrosine kinase receptor Tie2, and inhibition of angiogenesis has shown promise in the treatment of ovarian cancer. We aimed to assess whether trebananib, a peptibody that inhibits binding of angiopoietin 1 and 2 to Tie2, improved progression-free survival when added to carboplatin and paclitaxel as first-line therapy in advanced epithelial ovarian, primary fallopian tube, or peritoneal cancer in a phase 3 clinical trial.
METHODS


TRINOVA-3, a multicentre, multinational, phase 3, double-blind study, was done at 206 investigational sites (hospitals and cancer centres) in 14 countries. Eligible patients were aged 18 years or older with biopsy-confirmed International Federation of Gynecology and Obstetrics (FIGO) stage III to IV epithelial ovarian, primary peritoneal, or fallopian tube cancers, and an ECOG performance status of 0 or 1. Eligible patients were randomly assigned (2:1) using a permuted block method (block size of six patients) to receive six cycles of paclitaxel (175 mg/m 2 ) and carboplatin (area under the serum concentration-time curve 5 or 6) every 3 weeks, plus weekly intravenous trebananib 15 mg/kg or placebo. Maintenance therapy with trebananib or placebo continued for up to 18 additional months. The primary endpoint was progression-free survival, as assessed by the investigators, in the intention-to-treat population. Safety analyses included patients who received at least one dose of study treatment. This trial is registered with ClinicalTrials.gov, number NCT01493505, and is complete.
FINDINGS


Between Jan 30, 2012, and Feb 25, 2014, 1164 patients were screened and 1015 eligible patients were randomly allocated to treatment (678 to trebananib and 337 to placebo). After a median follow-up of 27·4 months (IQR 17·7-34·2), 626 patients had progression-free survival events (405 [60%] of 678 in the trebananib group and 221 [66%] of 337 in the placebo group). Median progression-free survival did not differ between the trebananib group (15·9 months [15·0-17·6]) and the placebo group (15·0 months [12·6-16·1]) groups (hazard ratio 0·93 [95% CI 0·79-1·09]; p=0·36). 512 (76%) of 675 patients in the trebananib group and 237 (71%) of 336 in the placebo group had grade 3 or worse treatment-emergent adverse events; of which the most common events were neutropenia (trebananib 238 [35%] vs placebo 126 [38%]) anaemia (76 [11%] vs 40 [12%]), and leucopenia (81 [12%] vs 35 [10%]). 269 (40%) patients in the trebananib group and 104 (31%) in the placebo group had serious adverse events. Two fatal adverse events in the trebananib group were considered related to trebananib, paclitaxel, and carboplatin (lung infection and neutropenic colitis); two were considered to be related to paclitaxel and carboplatin (general physical health deterioration and platelet count decreased). No treatment-related fatal adverse events occurred in the placebo group.
INTERPRETATION


Trebananib plus carboplatin and paclitaxel did not improve progression-free survival as first-line treatment for advanced ovarian cancer. The combination of trebananib plus carboplatin and paclitaxel did not produce new safety signals. These results show that trebananib in combination with carboplatin and paclitaxel is minimally effective in this patient population.
FUNDING


Amgen.",2019,"No treatment-related fatal adverse events occurred in the placebo group.
","['advanced ovarian cancer', 'advanced ovarian cancer (TRINOVA-3/ENGOT-ov2/GOG-3001', 'Between Jan 30, 2012, and Feb 25, 2014, 1164 patients were screened and 1015 eligible patients', '206 investigational sites (hospitals and cancer centres) in 14 countries', 'patients who received at least one dose of study treatment', 'advanced epithelial ovarian, primary fallopian tube, or peritoneal cancer in a phase 3 clinical trial', 'Eligible patients', 'Eligible patients were aged 18 years or older with biopsy-confirmed International Federation of Gynecology and Obstetrics (FIGO) stage III to IV epithelial ovarian, primary peritoneal, or fallopian tube cancers, and an ECOG performance status of 0 or 1']","['carboplatin', 'placebo', 'Trebananib plus carboplatin and paclitaxel', 'trebananib 15 mg/kg or placebo', 'trebananib plus carboplatin and paclitaxel', 'carboplatin and paclitaxel', 'Trebananib or placebo plus carboplatin and paclitaxel', 'trebananib or placebo', 'paclitaxel and carboplatin', 'permuted block method (block size of six patients) to receive six cycles of paclitaxel']","['anaemia', 'grade 3 or worse treatment-emergent adverse events', 'progression-free survival', 'progression-free survival events', 'neutropenia', 'trebananib, paclitaxel, and carboplatin (lung infection and neutropenic colitis', 'leucopenia', 'serious adverse events', 'Median progression-free survival', 'fatal adverse events']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0015560', 'cui_str': 'Oviducts, Mammalian'}, {'cui': 'C0153467', 'cui_str': 'Malignant tumor of peritoneum (disorder)'}, {'cui': 'C1096780', 'cui_str': 'Clinical Trial, Phase 3'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0450454', 'cui_str': 'FIGO Stage'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0442034', 'cui_str': 'Peritoneal (qualifier value)'}, {'cui': 'C0238122', 'cui_str': 'Fallopian Tube Cancer'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}]","[{'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3660912', 'cui_str': 'trenananib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C3660912', 'cui_str': 'trenananib'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0876973', 'cui_str': 'Pulmonary infection'}, {'cui': 'C0400823', 'cui_str': 'Neutropenic colitis (disorder)'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}]",1164.0,0.629914,"No treatment-related fatal adverse events occurred in the placebo group.
","[{'ForeName': 'Ignace', 'Initials': 'I', 'LastName': 'Vergote', 'Affiliation': 'Belgium and Luxembourg Gynaecological Oncology Group (BGOG), Leuven, Belgium; European Network of Gynaecological Oncological Trial groups (ENGOT), Divison of Gynecologic Oncology, Leuven Cancer Institute, KU Leuven, Leuven, Belgium. Electronic address: ignace.vergote@uzleuven.be.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': 'Multicenter Italian Trials in Ovarian Cancer Society (MITO), Rome, Italy; Fondazione Policlinico Universitario A Gemelli, Istituto di Ricovero e Cura a Carattere Scientifico, Università Cattolica, Rome, Italy.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': ""O'Malley"", 'Affiliation': 'Gynecologic Oncology Group, James Comprehensive Cancer Center, Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Van Calster', 'Affiliation': 'Belgium and Luxembourg Gynaecological Oncology Group (BGOG), Leuven, Belgium; Department of Development and Regeneration, KU Leuven, Leuven, Belgium; Department of Biomedical Data Sciences, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Sang-Yoon', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Del Campo', 'Affiliation': ""Grupo Español de Investigación en Cáncer de Ovario (GEICO), Department of Medical Oncology, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Meier', 'Affiliation': 'Arbeitsgemeinschaft Gynaekologische Onkologie Study Group (AGO), Department of Gynecology and Obstetrics, AGO-Germany and Evangelic Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Aristotelis', 'Initials': 'A', 'LastName': 'Bamias', 'Affiliation': 'Department of Clinical Therapeutics, Alexandra Hospital, National & Kapodistrian University of Athens, Athens, Greece; Hellenic Cooperative Oncology Group (HECOG), Athens, Greece.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Colombo', 'Affiliation': 'Mario Negri Gynecologic Oncology Group (MANGO), European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy; Università Milano Bicocca, Milan, Italy.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Wenham', 'Affiliation': 'Gynecologic Oncology Group, Department of Gynecologic Oncology, H Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.'}, {'ForeName': 'Al', 'Initials': 'A', 'LastName': 'Covens', 'Affiliation': 'Division of Gynecologic Oncology, Toronto Sunnybrook Regional Cancer Center, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Marth', 'Affiliation': 'Arbeitsgemeinschaft Gynaekologische Onkologie Study Group (AGO)-Austria, Department of Obstetrics and Gynecology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Mansoor', 'Initials': 'M', 'LastName': 'Raza Mirza', 'Affiliation': 'Nordic Society of Gynaecological Oncology (NSGO), Department of Oncology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Judith R', 'Initials': 'JR', 'LastName': 'Kroep', 'Affiliation': 'Dutch Gynecological Oncology Group (DCOG), Department of Medical Oncology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Haijun', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'Global Development Oncology, Amgen, Thousand Oaks, CA, USA.'}, {'ForeName': 'Cheryl A', 'Initials': 'CA', 'LastName': 'Pickett', 'Affiliation': 'Global Development Oncology, Amgen, Thousand Oaks, CA, USA.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Monk', 'Affiliation': 'Gynecologic Oncology Group, Arizona Oncology (US Oncology Network), University of Arizona, Phoenix, AZ, USA; Creighton University, Phoenix, AZ, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30178-0']
1283,31629997,tDCS increases anxiety reactivity to intentional worry.,"While considerable experimental research has examined the impact of transcranial direct current stimulation (tDCS) on a range of cognitive processes associated with emotional pathology, the impact of tDCS on worry has been comparatively neglected. Given that anxiety pathology is characterised by motivated engagement in worry, and that frontal tDCS has the capacity to enhance goal-oriented cognition, it is important to examine whether tDCS would increase or ameliorate the cognitive and emotional effects of worry. In the current study we examined how tDCS influenced the anxiety response to worry, and the frequency of negative intrusive thoughts. We additionally examined whether stimulation delivered in isolation, or in combination with a mindful-focus task would augment the effects of tDCS. Ninety-seven (75 female) healthy participants received either active or sham anodal tDCS to the left dorsolateral prefrontal cortex, delivered either in isolation or concurrently with a mindful task (four conditions). The frequency of negative thought intrusions was assessed before and after a period of instructed worry, and state anxiety was assessed across the study. Active tDCS was associated with significantly greater elevation in anxiety in response to the worry induction. No effects were observed on the frequency of negative thought intrusions, and the combined delivery of tDCS with the concurrent mindful task did not alter the pattern of observed effects. While inviting replication in a high anxious sample, the present results highlight the possibility that tDCS may interact with motivated engagement in negative patterns of cognition, such as worry, to produce greater emotional reactivity.",2020,"No effects were observed on the frequency of negative thought intrusions, and the combined delivery of tDCS with the concurrent mindful task did not alter the pattern of observed effects.",['Ninety-seven (75 female) healthy participants'],"['transcranial direct current stimulation (tDCS', 'active or sham anodal tDCS to the left dorsolateral prefrontal cortex, delivered either in isolation or concurrently with a mindful task (four conditions', 'tDCS']",['anxiety reactivity'],"[{'cui': 'C0439073', 'cui_str': '97 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0450424', 'cui_str': 'To the left (qualifier value)'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}, {'cui': 'C0220862', 'cui_str': 'isolation'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}]",75.0,0.0176484,"No effects were observed on the frequency of negative thought intrusions, and the combined delivery of tDCS with the concurrent mindful task did not alter the pattern of observed effects.","[{'ForeName': 'Patrick J F', 'Initials': 'PJF', 'LastName': 'Clarke', 'Affiliation': 'School of Psychology, Curtin University, Australia. Electronic address: patrick.clarke@curtin.edu.au.'}, {'ForeName': 'Brodie F', 'Initials': 'BF', 'LastName': 'Sprlyan', 'Affiliation': 'School of Psychology, Curtin University, Australia.'}, {'ForeName': 'Colette R', 'Initials': 'CR', 'LastName': 'Hirsch', 'Affiliation': ""Institute of Psychiatry, Department of Psychology, King's College London, United Kingdom.""}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Meeten', 'Affiliation': 'School of Psychology, University of Sussex, United Kingdom.'}, {'ForeName': 'Lies', 'Initials': 'L', 'LastName': 'Notebaert', 'Affiliation': 'Centre for the Advancement of Research on Emotion, School of Psychology, University of Western Australia, Australia.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2019.10.013']
1284,31021358,"Effects of 12 Weeks of Essential Amino Acids (EAA)-Based Multi-Ingredient Nutritional Supplementation on Muscle Mass, Muscle Strength, Muscle Power and Fatigue in Healthy Elderly Subjects: A Randomized Controlled Double-Blind Study.","OBJECTIVE


To counteract muscle mass, muscle strength and power loss during aging, and to study age-related change of neuromuscular manifestation of fatigue in relation to nutritional supplementation.
DESIGN


randomized controlled double-blind study.
SETTING


Twice-daily consumption for 12 weeks of an Essential Amino Acids (EAA)-based multi-ingredient nutritional supplement containing EAA, creatine, vitamin D and Muscle Restore Complex®.
PARTICIPANTS


38 healthy elderly subjects (8 male, 30 female; age: 68.91±4.60 years; body weight: 69.40±15.58 kg; height: 1.60±0.09 m) were randomized and allocated in supplement (SUPP) or placebo (PLA) group. Mean Measurements: Vitamin D blood level; Appendicular Lean Mass (ALM); Visceral Adipose Tissue (VAT); Maximal Voluntary Contraction (MVC) and Peak Power (PP); myoelectric descriptors of fatigue: Fractal Dimension and Conduction Velocity initial values (FD iv, CV iv), their rates of change (FD slopes, CV slopes) and the Time to perform the Task (TtT). Mean Results: Significant changes were found in SUPP compared to baseline: Vitamin D (+8.73 ng/ml; p<0.001); ALM (+0.34 kg; p<0.001); VAT (-76.25 g; p<0.001); MVC (+0.52 kg; p<0.001); PP (+4.82 W; p<0.001). Between group analysis (SUPP Vs. PLA) showed improvements: vitamin D blood levels (+11,72 ng/ml; p<0.001); Legs FFM (+443.7 g; p<0.05); ALM (+0.53 kg; p<0.05); MVC (+1.38 kg; p<0.05); PP (+9.87 W; p<0.05). No statistical changes were found for FD iv, CV iv, FD and CV slopes and TtT, either compared to baseline or between groups. Significant correlations between mean differences in SUPP group were also found.
CONCLUSION


The study demonstrates that in healthy elderly subjects an EAA-based multi-ingredient nutritional supplementation of 12 weeks is not effective to change myoelectric manifestation of fatigue and TtT failure but can positively affect muscle mass, muscle strength, muscle power and VAT, counterbalancing more than one year of age-related loss of muscle mass and strength.",2019,"PLA) showed improvements: vitamin D blood levels (+11,72 ng/ml; p<0.001); Legs FFM (+443.7 g; p<0.05); ALM (+0.53 kg; p<0.05); MVC (+1.38 kg; p<0.05); PP (+9.87 W; p<0.05).","['38 healthy elderly subjects (8 male, 30 female; age: 68.91±4.60 years; body weight: 69.40±15.58 kg; height: 1.60±0.09 m', 'Healthy Elderly Subjects', 'healthy elderly subjects']","['Essential Amino Acids (EAA)-based multi-ingredient nutritional supplement containing EAA, creatine, vitamin D and Muscle Restore Complex®', 'Essential Amino Acids (EAA)-Based Multi-Ingredient Nutritional Supplementation', 'supplement (SUPP) or placebo (PLA', 'PLA']","['Legs FFM', 'SUPP', 'improvements: vitamin D blood levels', 'Mean Measurements: Vitamin D blood level; Appendicular Lean Mass (ALM); Visceral Adipose Tissue (VAT); Maximal Voluntary Contraction (MVC) and Peak Power (PP); myoelectric descriptors of fatigue: Fractal Dimension and Conduction Velocity initial values (FD iv, CV iv), their rates of change (FD slopes, CV slopes) and the Time to perform the Task (TtT', 'FD iv, CV iv, FD and CV slopes and TtT', 'Muscle Mass, Muscle Strength, Muscle Power and Fatigue']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]","[{'cui': 'C0002525', 'cui_str': 'Amino Acids, Essential'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplement'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0282354', 'cui_str': 'Descriptors'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0206163', 'cui_str': 'Fractals'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0234084', 'cui_str': 'Conduction rate of nerve cell and nerve fiber, function (observable entity)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}]",38.0,0.230669,"PLA) showed improvements: vitamin D blood levels (+11,72 ng/ml; p<0.001); Legs FFM (+443.7 g; p<0.05); ALM (+0.53 kg; p<0.05); MVC (+1.38 kg; p<0.05); PP (+9.87 W; p<0.05).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Negro', 'Affiliation': ""Giuseppe D'Antona, CRIAMS-Sport Medicine Centre, University of Pavia, Voghera, Italy, gdantona@unipv.it.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Perna', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Spadaccini', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Castelli', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Calanni', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Barbero', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cescon', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rondanelli', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': ""D'Antona"", 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-019-1163-4']
1285,31853104,Role of placental blood drainage as a part of active management of third stage of labour after spontaneous vaginal delivery.,"OBJECTIVE


To compare the duration of 3rd stage of labour and blood-loss in patients with and without placental cord blood drainage following normal vaginal delivery.
METHODS


The quasi-experimental study was conducted at the Services Hospital, Lahore, Pakistan, from October4, 2015, to April 4, 2016, and comprised pregnant women aged 18-40 years with any parity having gestation >36 weeks and haemoglobin >7.0gm. The subjects were divided into two groups. In one group, routine active management of third stage of labour was done and placental end of the umbilical cord was left open to drain blood in a kidney tray till flow ceased. In the other group, the placental end of the cord was left clamped and spontaneous expulsion was carried out by controlled cord traction. Data was analysed using SPSS 22.
RESULTS


Of the 200 females, 100(50%) were in each of the two groups. The overall mean age was 29.22}6.84 years. The mean baseline haemoglobin in placental cord drainage group was 11.48}0.89 and that in the control group was 11.40 } 0.91 (p>0.05). The mean duration of third stage of labour in placental cord drainage group was 5.67}1.81 hours and in control group it was 8.44}2.50 hours (p<0.001). The mean blood-loss in placental cord drainage group was 174.69}13.69mlcompared to 196.25}15.06ml in the control group (p<0.001).
CONCLUSIONS


In the management of the third stage of labour with the cord drainage method, results showed significant reduction in postpartum blood-loss and the duration of the third stage in normal vaginal birth patients.",2019,The mean baseline haemoglobin in placental cord drainage group was 11.48}0.89 and that in the control group was 11.40 } 0.91 (p>0.05).,"['third stage of labour after spontaneous vaginal delivery', 'normal vaginal birth patients', 'patients with and without placental cord blood drainage following normal vaginal delivery', 'Services Hospital, Lahore, Pakistan, from October4, 2015, to April 4, 2016, and comprised pregnant women aged 18-40 years with any parity having gestation >36 weeks and haemoglobin']",['placental blood drainage'],"['mean blood-loss', 'postpartum blood-loss', 'mean duration of third stage of labour', 'mean baseline haemoglobin']","[{'cui': 'C0022873', 'cui_str': 'Third Stage Labor'}, {'cui': 'C1384485', 'cui_str': 'Delivery normal (finding)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]","[{'cui': 'C0005768'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0474482', 'cui_str': 'Duration of third stage of labor (observable entity)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",,0.0617905,The mean baseline haemoglobin in placental cord drainage group was 11.48}0.89 and that in the control group was 11.40 } 0.91 (p>0.05).,"[{'ForeName': 'Maryam Binte', 'Initials': 'MB', 'LastName': 'Afzal', 'Affiliation': 'Services Hospital, Lahore.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Bushra', 'Affiliation': 'Services Hospital, Lahore.'}, {'ForeName': 'Khadija', 'Initials': 'K', 'LastName': 'Waheed', 'Affiliation': 'King Edward Medical University, Lahore.'}, {'ForeName': 'Aleena', 'Initials': 'A', 'LastName': 'Sarwar', 'Affiliation': 'Lady Aitchison Hospital Lahore, Pakistan.'}, {'ForeName': 'Nukhbat Ullah', 'Initials': 'NU', 'LastName': 'Awan', 'Affiliation': 'King Edward Medical University, Lahore.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.302642458']
1286,31732552,Longterm Effect on Leisure Time Physical Activity Level in Individuals with Axial Spondyloarthritis: Secondary Analysis of a Randomized Controlled Trial.,"OBJECTIVE


To explore the longterm effect of a 3-month exercise program on leisure time physical activity level in individuals with axial spondyloarthritis (axSpA).
METHODS


A secondary analysis was performed on data from 100 individuals with axSpA who were included in a randomized controlled trial. The exercise group (EG) participated in a 3-month exercise program while the control group (CG) received no intervention. Physical activity during leisure time was measured with a questionnaire (physically active: ≥ 1 h/week with moderate/vigorous intensity physical activity). Disease activity was measured with the Ankylosing Spondylitis Disease Activity Scale (ASDAS; higher score = worst). Statistical analyses were performed on an intention-to-treat basis using chi-square tests, logistic regression, and mixed models.
RESULTS


At the 12-month followup, significantly more individuals in the EG than in the CG were physically active [29 (67%) vs 13 (30%), p < 0.001] and exercised 2-3 times/week [25 (58%) vs 15 (34%), p = 0.02], and fewer exercised at light intensity [3 (8%) vs 14 (44%), p = 0.002]. ""Participation in the EG"" (OR 6.7, 95% CI 2.4-18.6, p < 0.001) and ""being physically active at baseline"" (OR 4.7, 95% CI 1.4-15.8, p = 0.01) were the factors most associated with being physically active. There were no differences between the groups in ASDAS (p = 0.79).
CONCLUSION


A 3-month exercise program had a beneficial longterm effect on leisure time physical activity in individuals with axSpA, thus indicating a more beneficial health profile. Still, few individuals continued the intensive program, and there was no difference between the groups in disease activity after 12 months. (ClinicalTrials.gov: NCT02356874).",2019,"A 3-month exercise programme had a beneficial long-term effect on leisure time physical activity in individuals with axSpA, thus indicating a more beneficial health profile.","['100 individuals with axSpA', 'individuals with axSpA', 'individuals with axial spondyloarthritis (axSpA', 'individuals with axial spondyloarthritis']","['exercise programme while the control group (CG) received no intervention', 'exercise programme']","['leisure time physical activity', 'Physical activity during leisure time', 'leisure time physical activity level', 'Ankylosing Spondylitis Disease Activity Scale (ASDAS', 'disease activity', 'Disease activity']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis (disorder)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0038013', 'cui_str': 'Spondylarthritis Ankylopoietica'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0222045'}]",100.0,0.143508,"A 3-month exercise programme had a beneficial long-term effect on leisure time physical activity in individuals with axSpA, thus indicating a more beneficial health profile.","[{'ForeName': 'Silje Halvorsen', 'Initials': 'SH', 'LastName': 'Sveaas', 'Affiliation': 'From the National Advisory Unit on Rehabilitation in Rheumatology, Department of Rheumatology, Diakonhjemmet Hospital, Oslo; Department of Physiotherapy, Martina Hansens Hospital, Bærum; Department of Physiotherapy, University Hospital of North Norway, Tromsø; Department of Coaching and Psychology, Norwegian School of Sport Sciences, Oslo; The Norwegian Rheumatology Association, Norway; Institute of Neuroscience and Physiology, Section of Health and Rehabilitation, Physiotherapy, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. Supported by The Norwegian Fund for Post-Graduate Training in Physiotherapy and the Norwegian Rheumatology Association. S.H. Sveaas, PhD, National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital; H. Dagfinrud, PhD, National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital; M.W. Johansen, MSc, Department of Physiotherapy, Martina Hansens Hospital; E. Pedersen, PT, the Department of Physiotherapy, University Hospital of North Norway; O.M. Wold, MSc, Department of Coaching and Psychology, Norwegian School of Sport Sciences, and The Norwegian Rheumatology Association; A. Bilberg, PhD, Institute of Neuroscience and Physiology, Section of Health and Rehabilitation, Physiotherapy, Sahlgrenska Academy, University of Gothenburg. Address correspondence to S.H. Sveaas, National Advisory Unit on Rehabilitation in Rheumatology, Department of Rheumatology, Diakonhjemmet Hospital, PO Box 23 Vinderen, 0319 Oslo, Norway. E-mail: s.h.sveaas@medisin.uio.no Accepted for publication November 4, 2019.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Dagfinrud', 'Affiliation': 'From the National Advisory Unit on Rehabilitation in Rheumatology, Department of Rheumatology, Diakonhjemmet Hospital, Oslo; Department of Physiotherapy, Martina Hansens Hospital, Bærum; Department of Physiotherapy, University Hospital of North Norway, Tromsø; Department of Coaching and Psychology, Norwegian School of Sport Sciences, Oslo; The Norwegian Rheumatology Association, Norway; Institute of Neuroscience and Physiology, Section of Health and Rehabilitation, Physiotherapy, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. Supported by The Norwegian Fund for Post-Graduate Training in Physiotherapy and the Norwegian Rheumatology Association. S.H. Sveaas, PhD, National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital; H. Dagfinrud, PhD, National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital; M.W. Johansen, MSc, Department of Physiotherapy, Martina Hansens Hospital; E. Pedersen, PT, the Department of Physiotherapy, University Hospital of North Norway; O.M. Wold, MSc, Department of Coaching and Psychology, Norwegian School of Sport Sciences, and The Norwegian Rheumatology Association; A. Bilberg, PhD, Institute of Neuroscience and Physiology, Section of Health and Rehabilitation, Physiotherapy, Sahlgrenska Academy, University of Gothenburg. Address correspondence to S.H. Sveaas, National Advisory Unit on Rehabilitation in Rheumatology, Department of Rheumatology, Diakonhjemmet Hospital, PO Box 23 Vinderen, 0319 Oslo, Norway. E-mail: s.h.sveaas@medisin.uio.no Accepted for publication November 4, 2019.'}, {'ForeName': 'Melissa Woll', 'Initials': 'MW', 'LastName': 'Johansen', 'Affiliation': 'From the National Advisory Unit on Rehabilitation in Rheumatology, Department of Rheumatology, Diakonhjemmet Hospital, Oslo; Department of Physiotherapy, Martina Hansens Hospital, Bærum; Department of Physiotherapy, University Hospital of North Norway, Tromsø; Department of Coaching and Psychology, Norwegian School of Sport Sciences, Oslo; The Norwegian Rheumatology Association, Norway; Institute of Neuroscience and Physiology, Section of Health and Rehabilitation, Physiotherapy, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. Supported by The Norwegian Fund for Post-Graduate Training in Physiotherapy and the Norwegian Rheumatology Association. S.H. Sveaas, PhD, National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital; H. Dagfinrud, PhD, National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital; M.W. Johansen, MSc, Department of Physiotherapy, Martina Hansens Hospital; E. Pedersen, PT, the Department of Physiotherapy, University Hospital of North Norway; O.M. Wold, MSc, Department of Coaching and Psychology, Norwegian School of Sport Sciences, and The Norwegian Rheumatology Association; A. Bilberg, PhD, Institute of Neuroscience and Physiology, Section of Health and Rehabilitation, Physiotherapy, Sahlgrenska Academy, University of Gothenburg. Address correspondence to S.H. Sveaas, National Advisory Unit on Rehabilitation in Rheumatology, Department of Rheumatology, Diakonhjemmet Hospital, PO Box 23 Vinderen, 0319 Oslo, Norway. E-mail: s.h.sveaas@medisin.uio.no Accepted for publication November 4, 2019.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Pedersen', 'Affiliation': 'From the National Advisory Unit on Rehabilitation in Rheumatology, Department of Rheumatology, Diakonhjemmet Hospital, Oslo; Department of Physiotherapy, Martina Hansens Hospital, Bærum; Department of Physiotherapy, University Hospital of North Norway, Tromsø; Department of Coaching and Psychology, Norwegian School of Sport Sciences, Oslo; The Norwegian Rheumatology Association, Norway; Institute of Neuroscience and Physiology, Section of Health and Rehabilitation, Physiotherapy, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. Supported by The Norwegian Fund for Post-Graduate Training in Physiotherapy and the Norwegian Rheumatology Association. S.H. Sveaas, PhD, National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital; H. Dagfinrud, PhD, National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital; M.W. Johansen, MSc, Department of Physiotherapy, Martina Hansens Hospital; E. Pedersen, PT, the Department of Physiotherapy, University Hospital of North Norway; O.M. Wold, MSc, Department of Coaching and Psychology, Norwegian School of Sport Sciences, and The Norwegian Rheumatology Association; A. Bilberg, PhD, Institute of Neuroscience and Physiology, Section of Health and Rehabilitation, Physiotherapy, Sahlgrenska Academy, University of Gothenburg. Address correspondence to S.H. Sveaas, National Advisory Unit on Rehabilitation in Rheumatology, Department of Rheumatology, Diakonhjemmet Hospital, PO Box 23 Vinderen, 0319 Oslo, Norway. E-mail: s.h.sveaas@medisin.uio.no Accepted for publication November 4, 2019.'}, {'ForeName': 'Ole-Martin', 'Initials': 'OM', 'LastName': 'Wold', 'Affiliation': 'From the National Advisory Unit on Rehabilitation in Rheumatology, Department of Rheumatology, Diakonhjemmet Hospital, Oslo; Department of Physiotherapy, Martina Hansens Hospital, Bærum; Department of Physiotherapy, University Hospital of North Norway, Tromsø; Department of Coaching and Psychology, Norwegian School of Sport Sciences, Oslo; The Norwegian Rheumatology Association, Norway; Institute of Neuroscience and Physiology, Section of Health and Rehabilitation, Physiotherapy, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. Supported by The Norwegian Fund for Post-Graduate Training in Physiotherapy and the Norwegian Rheumatology Association. S.H. Sveaas, PhD, National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital; H. Dagfinrud, PhD, National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital; M.W. Johansen, MSc, Department of Physiotherapy, Martina Hansens Hospital; E. Pedersen, PT, the Department of Physiotherapy, University Hospital of North Norway; O.M. Wold, MSc, Department of Coaching and Psychology, Norwegian School of Sport Sciences, and The Norwegian Rheumatology Association; A. Bilberg, PhD, Institute of Neuroscience and Physiology, Section of Health and Rehabilitation, Physiotherapy, Sahlgrenska Academy, University of Gothenburg. Address correspondence to S.H. Sveaas, National Advisory Unit on Rehabilitation in Rheumatology, Department of Rheumatology, Diakonhjemmet Hospital, PO Box 23 Vinderen, 0319 Oslo, Norway. E-mail: s.h.sveaas@medisin.uio.no Accepted for publication November 4, 2019.'}, {'ForeName': 'Annelie', 'Initials': 'A', 'LastName': 'Bilberg', 'Affiliation': 'From the National Advisory Unit on Rehabilitation in Rheumatology, Department of Rheumatology, Diakonhjemmet Hospital, Oslo; Department of Physiotherapy, Martina Hansens Hospital, Bærum; Department of Physiotherapy, University Hospital of North Norway, Tromsø; Department of Coaching and Psychology, Norwegian School of Sport Sciences, Oslo; The Norwegian Rheumatology Association, Norway; Institute of Neuroscience and Physiology, Section of Health and Rehabilitation, Physiotherapy, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. Supported by The Norwegian Fund for Post-Graduate Training in Physiotherapy and the Norwegian Rheumatology Association. S.H. Sveaas, PhD, National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital; H. Dagfinrud, PhD, National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital; M.W. Johansen, MSc, Department of Physiotherapy, Martina Hansens Hospital; E. Pedersen, PT, the Department of Physiotherapy, University Hospital of North Norway; O.M. Wold, MSc, Department of Coaching and Psychology, Norwegian School of Sport Sciences, and The Norwegian Rheumatology Association; A. Bilberg, PhD, Institute of Neuroscience and Physiology, Section of Health and Rehabilitation, Physiotherapy, Sahlgrenska Academy, University of Gothenburg. Address correspondence to S.H. Sveaas, National Advisory Unit on Rehabilitation in Rheumatology, Department of Rheumatology, Diakonhjemmet Hospital, PO Box 23 Vinderen, 0319 Oslo, Norway. E-mail: s.h.sveaas@medisin.uio.no Accepted for publication November 4, 2019.'}]",The Journal of rheumatology,['10.3899/jrheum.190317']
1287,31038809,Conditioning pain modulation reduces pain only during the first stimulation of the temporal summation of pain paradigm in healthy participants.,"BACKGROUND


Pro-nociceptive and anti-nociceptive mechanisms are commonly assessed in clinical and experimental pain studies, but their potential interaction is not well understood.
OBJECTIVES


Investigate the effect of conditioning pain modulation (CPM) on temporal summation of pain (TSP).
METHODS


Twenty healthy participants underwent cuff algometry assessment on the lower legs to establish the pressure pain tolerance threshold (PTT). For the TSP assessment, ten stimuli at the level of the PTT were delivered by computerised cuff inflations (1-s stimulation, 1-s break) while participants rated pain intensity on a 10-cm electronic visual analogue scale (VAS). This TSP paradigm was then repeated with a simultaneous conditioning stimulus induced by a cuff on the contralateral leg, inflated to a constant pressure corresponding to 30% (mild), 70% (moderate) or 100% (severe) of the PTT. These were assessed in a randomised order, with a fifteen-minute break between tests. A final TSP test without conditioning was reassessed at the end (post-recording).
RESULTS


An interaction between stimuli (1-10) and repetition (p < 0.05) was found for VAS scores. VAS scores for the first stimulus were decreased during 30%, 70%, and 100% conditioning intensities, compared to baseline and post-recordings (p < 0.05). There was a significant increase in TSP during conditioning (p < 0.05). There were no significant differences between baseline and post-recordings for any stimuli (p > 0.05).
CONCLUSIONS


The current study indicates that mild to severe stimuli administered by cuff algometry does not modulate summation effect of temporal summation of pain, which could indicate that pain facilitatory mechanisms are more potent compared with pain inhibitory mechanisms.
SIGNIFICANCE


Current knowledge on the interaction effect of pro and anti-nociceptive paradigms are the lacking. The current study indicates that conditioning pain modulation does not modulate the summation effect of temporal summation of pain, when evaluated by computerized pressure algometry. This finding was independent of the mild, moderate and severe painful conditioning intensities.",2019,An interaction between stimuli (1-10) and repetition (p < 0.05) was found for VAS scores.,"['Twenty healthy participants underwent', 'healthy participants']","['conditioning pain modulation (CPM', 'cuff algometry assessment']","['pain', 'pain intensity on a 10-cm electronic visual analogue scale (VAS', 'VAS scores', 'TSP', 'pressure pain tolerance threshold (PTT', 'temporal summation of pain (TSP']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0392412', 'cui_str': 'cpm'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1533179', 'cui_str': 'Tsp'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation, function (observable entity)'}]",20.0,0.04558,An interaction between stimuli (1-10) and repetition (p < 0.05) was found for VAS scores.,"[{'ForeName': 'Sinead', 'Initials': 'S', 'LastName': 'Holden', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), SMI, Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Kristian Kjaer', 'Initials': 'KK', 'LastName': 'Petersen', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), SMI, Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Arendt-Nielsen', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), SMI, Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Graven-Nielsen', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), SMI, Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, Denmark.'}]","European journal of pain (London, England)",['10.1002/ejp.1408']
1288,31034304,"Low-Volume High-Intensity Interval Training (HIIT) versus Moderate-Intensity Continuous Training on Body Composition, Cardiometabolic Profile and Physical Capacity in Older Women.","OBJECTIVES


To compare the effect of low-volume HIIT to moderate-intensity aerobic training (MICT) on fat mass, cardiometabolic profile and physical capacity and confirm its feasibility in older women.
METHODS


Inactive older women (60-75 years) were randomly assigned to 8 weeks of either HIIT (75 min/week; n=9) or MICT (150 min/week; n=9). Body composition, fasting metabolic profile, cardiovascular risk (Framingham score), and physical capacity (senior fitness test, VO2peak) were assessed before and after the intervention. Feasibility was evaluated with  completion rate  (training compliance; dropout rate) and  affective response  (Feeling scale; pre- and post-exercise).
RESULTS


Total cholesterol, non-HDL-C levels and the Framingham risk score decreased in both groups (all  p ≤0.03). Although VO2peak remained unchanged, the 6MWT distance increased ( p <0.0001), irrespective of the group. Completion rate and affective responses were not different between groups (all  p ≥0.38).
CONCLUSION


A short-term HIIT program is feasible and provides as much benefits as MICT in older women.",2019,"Although VO2peak remained unchanged, the 6MWT distance increased ( p <0.0001), irrespective of the group.","['older women', 'Inactive older women (60-75 years', 'Older Women']","['Low-Volume High-Intensity Interval Training (HIIT) versus Moderate-Intensity Continuous Training', 'MICT', 'low-volume HIIT to moderate-intensity aerobic training (MICT']","['fat mass, cardiometabolic profile and physical capacity', 'Total cholesterol, non-HDL-C levels and the Framingham risk score', 'Body Composition, Cardiometabolic Profile and Physical Capacity', 'Completion rate and affective responses', '6MWT distance', 'Body composition, fasting metabolic profile, cardiovascular risk (Framingham score), and physical capacity (senior fitness test, VO2peak', 'completion rate  (training compliance; dropout rate) and  affective response  (Feeling scale; pre- and post-exercise']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C3853758', 'cui_str': 'Metabolic Profile'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0222045'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}]",,0.0192923,"Although VO2peak remained unchanged, the 6MWT distance increased ( p <0.0001), irrespective of the group.","[{'ForeName': 'Inès', 'Initials': 'I', 'LastName': 'Boukabous', 'Affiliation': '1 Faculty of Physical Activity Sciences, University of Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Marcotte-Chénard', 'Affiliation': '1 Faculty of Physical Activity Sciences, University of Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'Taha', 'Initials': 'T', 'LastName': 'Amamou', 'Affiliation': '1 Faculty of Physical Activity Sciences, University of Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Boulay', 'Affiliation': '1 Faculty of Physical Activity Sciences, University of Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Brochu', 'Affiliation': '1 Faculty of Physical Activity Sciences, University of Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Tessier', 'Affiliation': ""2 Research Center on Aging, CIUSSS de l'Estrie - CHUS, Sherbrooke, QC, Canada.""}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Dionne', 'Affiliation': '1 Faculty of Physical Activity Sciences, University of Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'Eléonor', 'Initials': 'E', 'LastName': 'Riesco', 'Affiliation': '1 Faculty of Physical Activity Sciences, University of Sherbrooke, Sherbrooke, QC, Canada.'}]",Journal of aging and physical activity,['10.1123/japa.2018-0309']
1289,31034311,The Effects of Low Intensity Resistance Exercise on Cardiac Autonomic Function and Muscle Strength in Obese Postmenopausal Women.,"The present study examined the effects of a 12-week low intensity resistance exercise training (LIRET) regimen on heart rate variability (HRV), strength and body composition in obese postmenopausal women. Participants were randomly assigned to 12 weeks of either LIRET (n= 10) or non-exercising control group (n= 10). HRV, leg muscle strength and body composition were measured before and after 12 weeks. There were significant decreases (P < 0.05) in sympathovagal balance (LnLF/LnHF) and sympathetic tone (nLF) as well as significant increases (P < 0.05) in parasympathetic tone (nHF) and strength following LIRET compared to no changes after control. There were no significant changes in body composition after LIRET or control. LIRET may be an effective therapeutic intervention for improving sympathovagal balance and strength in obese postmenopausal women. Since obese postmenopausal women are at increased risk of developing cardiovascular diseases and physical disability, they could potentially benefit from LIRET.",2019,There were significant decreases (P < 0.05) in sympathovagal balance (LnLF/LnHF) and sympathetic tone (nLF) as well as significant increases (P < 0.05) in parasympathetic tone (nHF) and strength following LIRET compared to no changes after control.,"['Obese Postmenopausal Women', 'obese postmenopausal women']","['Low Intensity Resistance Exercise', 'LIRET (n= 10) or non-exercising control', 'low intensity resistance exercise training (LIRET) regimen', 'LIRET']","['sympathovagal balance (LnLF/LnHF) and sympathetic tone (nLF', 'HRV, leg muscle strength and body composition', 'body composition', 'heart rate variability (HRV), strength and body composition', 'parasympathetic tone (nHF) and strength following LIRET', 'Cardiac Autonomic Function and Muscle Strength', 'sympathovagal balance and strength']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.0171287,There were significant decreases (P < 0.05) in sympathovagal balance (LnLF/LnHF) and sympathetic tone (nLF) as well as significant increases (P < 0.05) in parasympathetic tone (nHF) and strength following LIRET compared to no changes after control.,"[{'ForeName': 'Alexei', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': '1 Department of Health and Human Performance, Marymount University, Arlington, VA.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Figueroa', 'Affiliation': '2 Department of Kinesiology and Sport Management, Texas Tech University, Lubbock, TX.'}]",Journal of aging and physical activity,['10.1123/japa.2018-0418']
1290,31066631,Emotional reactivity to grief-related expressive writing.,"The efficacy of expressive writing for bereavement remains unclear, although some evidence suggests that writing about positive memories of one's loved one may be particularly beneficial. The current pilot study compared the effects of a brief positive expressive writing intervention for enhancing positive affect among bereaved adults ( N  = 403). Participants were randomly assigned to write about a positive memory of the deceased person or recent neutral activity. Results revealed no main effect of the positive writing condition on mood change. However, greater positive emotion word use mediated positive affect among those in the positive writing condition.",2020,Results revealed no main effect of the positive writing condition on mood change.,['bereaved adults (N\u2009=\u2009403'],"['positive expressive writing intervention', 'expressive writing']","['positive emotion', 'positive writing condition on mood change', 'Emotional reactivity to grief-related expressive writing']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0085633', 'cui_str': 'Mood swings (finding)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0018235', 'cui_str': 'Grief'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",,0.112839,Results revealed no main effect of the positive writing condition on mood change.,"[{'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Rubin', 'Affiliation': 'Department of Psychology, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Baylee', 'Initials': 'B', 'LastName': 'Hawkins', 'Affiliation': 'Department of Psychology, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Cobb', 'Affiliation': 'Department of Psychology, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Telch', 'Affiliation': 'Department of Psychology, The University of Texas at Austin, Austin, TX, USA.'}]",Death studies,['10.1080/07481187.2019.1595219']
1291,31852712,"Ascorbic Acid, Corticosteroids and Thiamine in Sepsis (ACTS) protocol and statistical analysis plan: a prospective, multicentre, double-blind, randomised, placebo-controlled clinical trial.","INTRODUCTION


Septic shock is a common and highly morbid condition. To date, there is no specific therapy proven to attenuate organ injury in septic shock. Recent studies have suggested a role for the combination of ascorbic acid, corticosteroids and thiamine, although randomised data are lacking.
METHODS AND ANALYSIS


The Ascorbic Acid, Corticosteroids, and Thiamine in Sepsis trial is a multi-centre, double-blind, randomised, placebo-controlled clinical trial that aims to determine the impact of ascorbic acid, corticosteroids and thiamine versus placebo on organ injury and mortality in patients with septic shock. Patients are randomised to receive 1500 mg of ascorbic acid, 100 mg of thiamine and 50 mg of hydrocortisone parenterally versus matching placebo every 6 hours for 4 days. Clinical and laboratory data are collected at the time of study enrolment, at 24, 72 and 120 hours. The primary end-point for the trial is change in the Sequential Organ Failure Assessment score between enrolment and 72 hours. Additional key secondary outcomes include the incidence of renal failure and 30-day mortality.
ETHICS AND DISSEMINATION


The study was approved by the international review board of each participating study site. Study findings will be disseminated through peer-reviewed publications and conference presentations.
TRIAL REGISTRATION NUMBER


The trial is registered on clinicaltrials.gov (NCT03389555). It was posted on 3 January 2018.",2019,The primary end-point for the trial is change in the Sequential Organ Failure Assessment score between enrolment and 72 hours.,['patients with septic shock'],"['ascorbic acid, corticosteroids and thiamine versus placebo', 'Ascorbic Acid, Corticosteroids, and Thiamine', 'ascorbic acid, 100 mg of thiamine and 50 mg of hydrocortisone parenterally versus matching placebo', 'placebo', 'Ascorbic Acid, Corticosteroids and Thiamine', 'ascorbic acid, corticosteroids and thiamine']","['organ injury and mortality', 'Sequential Organ Failure Assessment score', 'incidence of renal failure and 30-day mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}]","[{'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0373727', 'cui_str': 'Vitamin B-1 measurement'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C3494459', 'cui_str': 'SOFAS Scores'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.823062,The primary end-point for the trial is change in the Sequential Organ Failure Assessment score between enrolment and 72 hours.,"[{'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Moskowitz', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, Beth Israel Deaconess Medical Center, Boston, MA, United States amoskowi@bidmc.harvard.edu.'}, {'ForeName': 'Tuyen', 'Initials': 'T', 'LastName': 'Yankama', 'Affiliation': 'Center for Resuscitation Science, Beth Israel Deaconess Medical Center, Boston, MA, United States.'}, {'ForeName': 'Lars W', 'Initials': 'LW', 'LastName': 'Andersen', 'Affiliation': 'Center for Resuscitation Science, Beth Israel Deaconess Medical Center, Boston, MA, United States.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Huang', 'Affiliation': 'Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Donnino', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, Beth Israel Deaconess Medical Center, Boston, MA, United States.'}, {'ForeName': 'Anne V', 'Initials': 'AV', 'LastName': 'Grossestreuer', 'Affiliation': 'Center for Resuscitation Science, Beth Israel Deaconess Medical Center, Boston, MA, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-034406']
1292,31853103,Intravenous dexamethasone along with caudal block improves analgesic efficacy following day-case inguinal hernia repair in children: A randomized controlled trial.,"OBJECTIVE


To assess the effectiveness of intravenous dexamethasone along with caudal block in improving analgesia following inguinal hernia repair in children.
METHODS


The double-blind randomised controlled trial was conducted over a 6-month period from June 01, 2016 to November 30, 2016 at the Aga Khan University Hospital, Karachi, and comprised patients aged 1-5 years, scheduled for elective inguinal hernia repair. The subjects were randomised into two groups using the sealed envelope technique. Group D patients received 0.5mg/kg dexamethasone intravenous in 5ml, and group P was given placebo (5ml 0.9% saline). Assessment of postoperative pain was made through the faces, legs, activity, cry and consolability tool at 30 minutes and hourly for 4 hours. Rescue analgesia was given at pain score 3 or more with intravenous pethidine 0.5 mg/kg. SPSS 19 was used for data analysis.
RESULTS


Of the 64 patients, there were 55(85.9%) boys and 9(14.1%) girls. The overall mean age was 29.8}13.8 months. The mean postoperative pain score was significantly higher in group P (p<0.05). At 30 minutes and two hours postoperatively, need for analgesia was also significantly higher in group P (p<0.05).
CONCLUSIONS


In paediatric day-care inguinal hernia repair, dexamethasone could be used effectively for improving pain relief.",2019,The mean postoperative pain score was significantly higher in group P (p<0.05).,"['inguinal hernia repair in children', 'day-case inguinal hernia repair in children', '6-month period from June 01, 2016 to November 30, 2016 at the Aga Khan University Hospital, Karachi, and comprised patients aged 1-5 years, scheduled for elective inguinal hernia repair', '64 patients', 'girls']","['Intravenous dexamethasone', 'placebo', 'pethidine', 'dexamethasone']","['postoperative pain', 'need for analgesia', 'mean postoperative pain score', 'faces, legs, activity, cry and consolability tool', 'analgesic efficacy', 'pain relief']","[{'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia (procedure)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025376', 'cui_str': 'pethidine'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}]",,0.637266,The mean postoperative pain score was significantly higher in group P (p<0.05).,"[{'ForeName': 'Amjad', 'Initials': 'A', 'LastName': 'Nadeem', 'Affiliation': 'Department of Anaesthesiology, KRL Hospital, Islamabad , Pakistan.'}, {'ForeName': 'Aliya', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'Department of Anaesthesiology, Aga Khan University, Karachi, Pakistan.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.301035']
1293,31708060,Stroke Warning Information and Faster Treatment (SWIFT): Cost-Effectiveness of a Stroke Preparedness Intervention.,"BACKGROUND


Less than 25% of stroke patients arrive to an emergency department within the 3-hour treatment window.
OBJECTIVE


We evaluated the cost-effectiveness of a stroke preparedness behavioral intervention study (Stroke Warning Information and Faster Treatment [SWIFT]), a stroke intervention demonstrating capacity to decrease race-ethnic disparities in ED arrival times.
METHODS


Using the literature and SWIFT outcomes for 2 interventions, enhanced educational (EE) materials, and interactive intervention (II), we assess the cost-effectiveness of SWIFT in 2 ways: (1) Markov model, and (2) cost-to-outcome ratio. The Markov model primary outcome was the cost per quality-adjusted life-year (QALY) gained using the cost-effectiveness threshold of $100 000/QALY. The primary cost-to-outcome endpoint was cost per additional patient with ED arrival <3 hours, stroke knowledge, and preparedness capacity. We assessed the ICER of II and EE versus standard care (SC) from a health sector and societal perspective using 2015 USD, a time horizon of 5 years, and a discount rate of 3%.
RESULTS


The cost-effectiveness of the II and EE programs was, respectively, $227.35 and $74.63 per additional arrival <3 hours, $440.72 and $334.09 per additional person with stroke knowledge proficiency, and $655.70 and $811.77 per additional person with preparedness capacity. Using a societal perspective, the ICER for EE versus SC was $84 643 per QALY gained and the ICER for II versus EE was $59 058 per QALY gained. Incorporating fixed costs, EE and II would need to administered to 507 and 1693 or more patients, respectively, to achieve an ICER of $100 000/QALY.
CONCLUSION


II was a cost-effective strategy compared with both EE and SC. Nevertheless, high initial fixed costs associated with II may limit its cost-effectiveness in settings with smaller patient populations.",2019,"The cost-effectiveness of the II and EE programs was, respectively, $227.35 and $74.63 per additional arrival <3 hours, $440.72 and $334.09 per additional person with stroke knowledge proficiency, and $655.70 and $811.77 per additional person with preparedness capacity.",[],"['stroke preparedness behavioral intervention study (Stroke Warning Information and Faster Treatment [SWIFT', 'Stroke Warning Information and Faster Treatment (SWIFT', 'Stroke Preparedness Intervention']","['Cost-Effectiveness', 'ICER of II and EE versus standard care (SC', 'cost per additional patient with ED arrival <3 hours, stroke knowledge, and preparedness capacity', 'cost per quality-adjusted life-year (QALY) gained using the cost-effectiveness threshold of $100 000/QALY', 'cost-effectiveness']",[],"[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1831581', 'cui_str': 'Subfamily Apodinae'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]",,0.0544505,"The cost-effectiveness of the II and EE programs was, respectively, $227.35 and $74.63 per additional arrival <3 hours, $440.72 and $334.09 per additional person with stroke knowledge proficiency, and $655.70 and $811.77 per additional person with preparedness capacity.","[{'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Stevens', 'Affiliation': 'Department of Epidemiology, New York University College of Global Public Health, New York, NY, USA; Department of Population Health, New York University School of Medicine, New York, NY, USA. Electronic address: elizabeth.stevens@nyumc.org.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Roberts', 'Affiliation': 'Department of Epidemiology, New York University College of Global Public Health, New York, NY, USA.'}, {'ForeName': 'Heather Carman', 'Initials': 'HC', 'LastName': 'Kuczynski', 'Affiliation': 'Department of Epidemiology, New York University College of Global Public Health, New York, NY, USA.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Boden-Albala', 'Affiliation': 'Department of Epidemiology, New York University College of Global Public Health, New York, NY, USA.'}]",Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research,['10.1016/j.jval.2019.06.003']
1294,31593541,Results of MyPlan 2.0 on Physical Activity in Older Belgian Adults: Randomized Controlled Trial.,"BACKGROUND


The beneficial effects of physical activity (PA) for older adults are well known. However, few older adults reach the health guideline of 150 min per week of moderate-to-vigorous PA (MVPA). Electronic health (eHealth) interventions are effective in increasing PA levels in older adults in the short term but, rarely, intermediate-term effects after a period without the support of a website or an app have been examined. Furthermore, current theory-based interventions focus mainly on preintentional determinants, although postintentional determinants should also be included to increase the likelihood of successful behavior change.
OBJECTIVE


This study aimed to investigate the effect of the theory-based eHealth intervention, MyPlan 2.0, focusing on pre- and postintentional determinants on both accelerometer-based and self-reported PA levels in older Belgian adults in the short and intermediate term.
METHODS


This study was a randomized controlled trial with three data collection points: baseline (N=72), post (five weeks after baseline; N=65), and follow-up (three months after baseline; N=65). The study took place in Ghent, and older adults (aged ≥65 years) were recruited through a combination of random and convenience sampling. At all the time points, participants were visited by the research team. Self-reported domain-specific PA was assessed using the International Physical Activity Questionnaire, and accelerometers were used to objectively assess PA. Participants in the intervention group got access to the eHealth intervention, MyPlan 2.0, and used it independently for five consecutive weeks after baseline. MyPlan 2.0 was based on the self-regulatory theory and focused on both pre- and postintentional processes to increase PA. Multilevel mixed-models repeated measures analyses were performed in R (R Foundation for Statistical Computing).
RESULTS


Significant (borderline) positive intervention effects were found for accelerometer-based MVPA (baseline-follow-up: intervention group +5 min per day and control group -5 min per day; P=.07) and for accelerometer-based total PA (baseline-post: intervention group +20 min per day and control group -24 min per day; P=.05). MyPlan 2.0 was also effective in increasing self-reported PA, mainly in the intermediate term. A positive intermediate-term intervention effect was found for leisure-time vigorous PA (P=.02), moderate household-related PA (P=.01), and moderate PA in the garden (P=.04). Negative intermediate-term intervention effects were found for leisure-time moderate PA (P=.01) and cycling for transport (P=.07).
CONCLUSIONS


The findings suggest that theory-based eHealth interventions focusing on pre- and postintentional determinants have the potential for behavior change in older adults. If future studies including larger samples and long-term follow-up can confirm and clarify these findings, researchers and practitioners should be encouraged to use a self-regulation perspective for eHealth intervention development.
TRIAL REGISTRATION


Clinicaltrials.gov NCT03194334; https://clinicaltrials.gov/ct2/show/NCT03783611.",2019,"Negative intermediate-term intervention effects were found for leisure-time moderate PA (P=.01) and cycling for transport (P=.07).
","['older Belgian adults in the short and intermediate term', 'older adults (aged ≥65 years', 'Older Belgian Adults', 'older adults']","['Electronic health (eHealth) interventions', 'physical activity (PA', 'MyPlan']","['leisure-time vigorous PA', 'leisure-time moderate PA', 'PA levels', 'Physical Activity']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0337797', 'cui_str': 'Belgians (ethnic group)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",150.0,0.0344077,"Negative intermediate-term intervention effects were found for leisure-time moderate PA (P=.01) and cycling for transport (P=.07).
","[{'ForeName': 'Delfien', 'Initials': 'D', 'LastName': 'Van Dyck', 'Affiliation': 'Department of Movement and Sports Sciences, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Herman', 'Affiliation': 'Department of Movement and Sports Sciences, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Poppe', 'Affiliation': 'Department of Movement and Sports Sciences, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Crombez', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Faculty of Psychology and Educational Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'De Bourdeaudhuij', 'Affiliation': 'Department of Movement and Sports Sciences, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Freja', 'Initials': 'F', 'LastName': 'Gheysen', 'Affiliation': 'Department of Movement and Sports Sciences, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}]",Journal of medical Internet research,['10.2196/13219']
1295,32117242,Effect of Optimized Immunosuppression (Including Rituximab) on Anti-Donor Alloresponses in Patients With Chronically Rejecting Renal Allografts.,"RituxiCAN-C4 combined an open-labeled randomized controlled trial (RCT) in 7 UK centers to assess whether rituximab could stabilize kidney function in patients with chronic rejection, with an exploratory analysis of how B cell-depletion influenced T cell anti-donor responses relative to outcome. Between January 2007 and March 2015, 59 recruits were enrolled after screening, 23 of whom consented to the embedded RCT. Recruitment was halted when in a pre-specified per protocol interim analysis, the RCT was discovered to be significantly underpowered. This report therefore focuses on the exploratory analysis, in which we confirmed that when B cells promoted CD4+ anti-donor IFNγ production assessed by ELISPOT, this associated with inferior clinical outcome; these patterns were inhibited by optimized immunosuppression but not rituximab. B cell suppression of IFNγ production, which associated with number of transitional B cells and correlated with slower declines in kidney function was abolished by rituximab, which depleted transitional B cells for prolonged periods. We conclude that in this patient population, optimized immunosuppression but not rituximab promotes anti-donor alloresponses associated with favorable outcomes.  Clinical Trial Registration:  Registered with EudraCT (2006-002330-38) and www.ClinicalTrials.gov, identifier: NCT00476164.",2020,"B cell suppression of IFNγ production, which associated with number of transitional B cells and correlated with slower declines in kidney function was abolished by rituximab, which depleted transitional B cells for prolonged periods.","['Between January 2007 and March 2015, 59 recruits were enrolled after screening, 23 of whom consented to the embedded RCT', 'Patients', 'patients with chronic rejection', '2006-002330-38) and www']","['Optimized Immunosuppression (Including Rituximab', 'rituximab', 'EudraCT', 'RituxiCAN-C4 combined']","['CD4+ anti-donor IFNγ production', 'kidney function', 'number of transitional B cells']","[{'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}]","[{'cui': 'C0021080', 'cui_str': 'Immunosuppression (Physiology)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0033268'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1512631', 'cui_str': 'Transitional B-Cells'}]",,0.0792756,"B cell suppression of IFNγ production, which associated with number of transitional B cells and correlated with slower declines in kidney function was abolished by rituximab, which depleted transitional B cells for prolonged periods.","[{'ForeName': 'Kin Yee', 'Initials': 'KY', 'LastName': 'Shiu', 'Affiliation': ""Department of Inflammation Biology, MRC Centre for Transplantation, Guy's Hospital, King's College London, London, United Kingdom.""}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Stringer', 'Affiliation': ""Biostatistics and Health Informatics, The Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'McLaughlin', 'Affiliation': ""Department of Inflammation Biology, MRC Centre for Transplantation, Guy's Hospital, King's College London, London, United Kingdom.""}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Shaw', 'Affiliation': 'Viapath Analytics LLP, London, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Brookes', 'Affiliation': 'Histocompatibility and Immunogenetics, Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Burton', 'Affiliation': ""Department of Inflammation Biology, MRC Centre for Transplantation, Guy's Hospital, King's College London, London, United Kingdom.""}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Wilkinson', 'Affiliation': ""Department of Inflammation Biology, MRC Centre for Transplantation, Guy's Hospital, King's College London, London, United Kingdom.""}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Douthwaite', 'Affiliation': ""Department of Inflammation Biology, MRC Centre for Transplantation, Guy's Hospital, King's College London, London, United Kingdom.""}, {'ForeName': 'Tjir-Li', 'Initials': 'TL', 'LastName': 'Tsui', 'Affiliation': ""Department of Inflammation Biology, MRC Centre for Transplantation, Guy's Hospital, King's College London, London, United Kingdom.""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Mclean', 'Affiliation': 'Imperial College Renal and Transplant Centre, Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Hilton', 'Affiliation': ""Department of Nephrology and Transplantation, Guy's and St. Thomas' NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Griffin', 'Affiliation': 'Department of Nephrology, University Hospital of Wales, Cardiff, United Kingdom.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Geddes', 'Affiliation': 'Renal Unit, Western Infirmary, NHS Greater Glasgow and Clyde Trust, Glasgow, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Ball', 'Affiliation': 'Department of Nephrology, University Hospital Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Baker', 'Affiliation': ""Renal Unit, St. James's University Hospital, Leeds, United Kingdom.""}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Roufosse', 'Affiliation': 'Histocompatibility and Immunogenetics, Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Horsfield', 'Affiliation': ""Department of Histopathology, Guy's and St. Thomas' NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Dorling', 'Affiliation': ""Department of Inflammation Biology, MRC Centre for Transplantation, Guy's Hospital, King's College London, London, United Kingdom.""}]",Frontiers in immunology,['10.3389/fimmu.2020.00079']
1296,31036563,"Distinct effects of acute exercise and breaks in sitting on working memory and executive function in older adults: a three-arm, randomised cross-over trial to evaluate the effects of exercise with and without breaks in sitting on cognition.","BACKGROUND


Sedentary behaviour is associated with impaired cognition, whereas exercise can acutely improve cognition.
OBJECTIVE


We compared the effects of a morning bout of moderate-intensity exercise, with and without subsequent light-intensity walking breaks from sitting, on cognition in older adults.
METHODS


Sedentary overweight/obese older adults with normal cognitive function (n=67, 67±7 years, 31.2±4.1 kg/m 2 ) completed three conditions (6-day washout): SIT (sitting): uninterrupted sitting (8 hours, control); EX+SIT (exercise + sitting): sitting (1 hour), moderate-intensity walking (30 min), uninterrupted sitting (6.5 hours); and EX+BR (exercise + breaks): sitting (1 hour), moderate-intensity walking (30 min), sitting interrupted every 30 min with 3 min of light-intensity walking (6.5 hours). Cognitive testing (Cogstate) was completed at four time points assessing psychomotor function, attention, executive function, visual learning and working memory. Serum brain-derived neurotrophic growth factor (BDNF) was assessed at six time points. The 8-hour net area under the curve (AUC) was calculated for each outcome.
RESULTS


Working memory net AUC z-score·hour (95% CI) was improved in EX+BR with a z-score of +28 (-26 to +81), relative to SIT, -25 (-79 to +29, p=0.04 vs EX+BR). Executive function net AUC was improved in EX+SIT, -8 (- 71 to +55), relative to SIT, -80 (-142 to -17, p=0.03 vs EX+SIT). Serum BDNF net AUC ng/mL·hour (95% CI) was increased in both EX+SIT, +171 (-449 to +791, p=0.03 vs SIT), and EX+BR, +139 (-481 to +759, p=0.045 vs SIT), relative to SIT, -227 (-851 to +396).
CONCLUSION


A morning bout of moderate-intensity exercise improves serum BDNF and working memory or executive function in older adults, depending on whether or not subsequent sitting is also interrupted with intermittent light-intensity walking.
TRIAL REGISTRATION NUMBER


ACTRN12614000737639.",2020,"Executive function net AUC was improved in EX+SIT, -8 (- 71 to +55), relative to SIT, -80","['Sedentary overweight/obese older adults with normal cognitive function (n=67, 67±7 years, 31.2±4.1\u2009kg/m 2 ) completed three', 'older adults']","['morning bout of moderate-intensity exercise, with and without subsequent light-intensity walking breaks from sitting', 'moderate-intensity exercise', 'acute exercise and breaks in sitting', 'conditions (6-day washout): SIT (sitting): uninterrupted sitting (8\u2009hours, control); EX+SIT (exercise + sitting): sitting (1\u2009hour), moderate-intensity walking (30\u2009min), uninterrupted sitting (6.5\u2009hours); and EX+BR (exercise + breaks): sitting (1\u2009hour), moderate-intensity walking (30\u2009min), sitting interrupted every 30\u2009min with 3\u2009min of light-intensity walking']","['Serum BDNF net AUC ng/mL·hour', 'Cognitive testing (Cogstate', 'Serum brain-derived neurotrophic growth factor (BDNF', 'psychomotor function, attention, executive function, visual learning and working memory', 'serum BDNF and working memory or executive function', 'Working memory net AUC z-score·hour', 'Executive function net AUC', 'working memory and executive function', '8-hour net area under the curve (AUC']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1292429', 'cui_str': '8 hours (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0443239', 'cui_str': 'Interrupted (qualifier value)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C4704801', 'cui_str': 'Neurotrophic'}, {'cui': 'C0018284', 'cui_str': 'Growth factor (substance)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0582587', 'cui_str': 'Spatial Learning'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C1292429', 'cui_str': '8 hours (qualifier value)'}]",,0.054602,"Executive function net AUC was improved in EX+SIT, -8 (- 71 to +55), relative to SIT, -80","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Wheeler', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, Western Australia, Australia michael.wheeler@baker.edu.au.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Green', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Ellis', 'Affiliation': 'Academic Unit for Psychiatry of Old Age, Department of Psychiatry, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Cerin', 'Affiliation': 'Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ilkka', 'Initials': 'I', 'LastName': 'Heinonen', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Louise H', 'Initials': 'LH', 'LastName': 'Naylor', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Larsen', 'Affiliation': 'Physical Activity, Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Wennberg', 'Affiliation': 'Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Carl-Johan', 'Initials': 'CJ', 'LastName': 'Boraxbekk', 'Affiliation': 'Danish Research Centre for Magnetic Resonance, Copenhagen University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Jaye', 'Initials': 'J', 'LastName': 'Lewis', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Eikelis', 'Affiliation': 'Physical Activity, Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Nicola T', 'Initials': 'NT', 'LastName': 'Lautenschlager', 'Affiliation': 'Department of Psychiatry, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Bronwyn A', 'Initials': 'BA', 'LastName': 'Kingwell', 'Affiliation': 'Metabolic and Vascular Physiology Laboratory, Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Lambert', 'Affiliation': 'Iverson Health Innovation Research Institute and School of Health Science, Swinburne University of Technology, Melbourne, Victoria, Australia.'}, {'ForeName': 'Neville', 'Initials': 'N', 'LastName': 'Owen', 'Affiliation': 'Behavioural Epidemiology, Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dunstan', 'Affiliation': 'Physical Activity, Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.'}]",British journal of sports medicine,['10.1136/bjsports-2018-100168']
1297,31036468,"Tucidinostat plus exemestane for postmenopausal patients with advanced, hormone receptor-positive breast cancer (ACE): a randomised, double-blind, placebo-controlled, phase 3 trial.","BACKGROUND


Tucidinostat (formerly known as chidamide) is an oral subtype-selective histone deacetylase inhibitor. In an exploratory study, the combination of tucidinostat with exemestane showed preliminary signs of encouraging anti-tumour activity in patients with advanced hormone receptor-positive breast cancer. To build on these findings, we aimed to assess the efficacy and safety of this combination in a randomised trial in a larger population of postmenopausal patients with advanced, hormone receptor-positive breast cancer.
METHODS


We did the randomised, double-blind, placebo-controlled, phase 3 ACE trial at 22 specialist cancer centres in China. Eligible patients were postmenopausal women (aged ≥60 years or aged <60 years if their serum follicle-stimulating hormone and oestradiol concentrations were within postmenopausal ranges) with hormone receptor-positive, HER2-negative breast cancer, whose disease had relapsed or progressed after at least one endocrine therapy (either in advanced or metastatic or adjuvant setting), and who had at least one measurable lesion, adequate organ function, Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and adequate haematological and biochemical parameters. Endocrine therapy did not have to be the most recent therapy before randomisation, but recurrence or progression after the most recent therapy was a prerequisite. Patients were randomly assigned (2:1) by a dynamic randomisation scheme via an interactive web-response system to receive 30 mg oral tucidinostat or placebo twice weekly. All patients in both groups also received 25 mg oral exemestane daily. Randomisation was stratified according to the presence of visceral metastases (yes vs no). Patients, investigators, study site staff, and the sponsor were masked to treatment assignment. The primary endpoint was investigator-assessed progression-free survival. Efficacy analyses were done in the full analysis set population, comprising all patients who received at least one dose of any study treatment, and safety analyses were done in all patients who received at least one dose of any study treatment and for whom at least one safety case report form was available. This study is registered with ClinicalTrials.gov, number NCT02482753. The study has reached the required number of events for final analysis of the primary endpoint. The trial is no longer enrolling patients, but follow-up for investigation of overall survival is ongoing.
FINDINGS


Between July 20, 2015, and June 26, 2017, 365 patients were enrolled and randomly assigned, 244 to the tucidinostat group and 121 to the placebo group. The median duration of follow-up was 13·9 months (IQR 9·8-17·5). Investigator-assessed median progression-free survival was 7·4 months (95% CI 5·5-9·2) in the tucidinostat group and 3·8 months (3·7-5·5) in the placebo group (HR 0·75 [95% CI 0·58-0·98]; p=0·033). The most common grade 3 or 4 adverse events in either group were neutropenia (124 [51%] of 244 patients in the tucidinostat group vs three [2%] of 121 patients in the placebo group), thrombocytopenia (67 [27%] vs three [2%]), and leucopenia (46 [19%] vs three [2%]). Serious adverse events of any cause occurred in 51 (21%) of 244 patients in the tucidinostat group and seven (6%) of 121 patients in the placebo group. No treatment-related deaths were reported.
INTERPRETATION


Tucidinostat plus exemestane improved progression-free survival compared with placebo plus exemestane in patients with advanced, hormone receptor-positive, HER2-negative breast cancer that progressed after previous endocrine therapy. Grade 3-4 haematological adverse events were more common in the tucidinostat plus exemestane group than in the placebo plus exemestane group. Tucidinostat plus exemestane could represent a new treatment option for these patients.
FUNDING


Chipscreen Biosciences.",2019,Grade 3-4 haematological adverse events were more common in the tucidinostat plus exemestane group than in the placebo plus exemestane group.,"['Eligible patients were postmenopausal women (aged ≥60 years or aged <60 years if their serum follicle-stimulating hormone and oestradiol concentrations were within postmenopausal ranges) with hormone receptor-positive, HER2-negative breast cancer, whose disease had relapsed or progressed after at least one endocrine therapy (either in advanced or metastatic or adjuvant setting), and who had at least one measurable lesion, adequate organ function, Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and adequate haematological and biochemical parameters', '22 specialist cancer centres in China', 'Between July 20, 2015, and June 26, 2017, 365 patients were enrolled and randomly assigned, 244 to the tucidinostat group and 121 to the', 'postmenopausal patients with advanced, hormone receptor-positive breast cancer (ACE', 'postmenopausal patients with advanced, hormone receptor-positive breast cancer', 'patients with advanced, hormone receptor-positive, HER2-negative breast cancer that progressed after previous endocrine therapy', 'patients with advanced hormone receptor-positive breast cancer']","['Tucidinostat plus exemestane', 'placebo plus exemestane', 'placebo', 'Endocrine therapy', 'oral exemestane', 'exemestane', 'dynamic randomisation scheme via an interactive web-response system to receive 30 mg oral tucidinostat or placebo']","['median duration', 'Investigator-assessed median progression-free survival', 'progression-free survival', 'Grade 3-4 haematological adverse events', 'neutropenia', 'efficacy and safety', 'leucopenia', 'investigator-assessed progression-free survival', 'thrombocytopenia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0857927', 'cui_str': 'Serum follicle stimulating hormone'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517660', 'cui_str': 'Two hundred and forty-four'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0067453', 'cui_str': 'N-(2-acetamido)-2-aminoethanesulfonic acid'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}]",22.0,0.664732,Grade 3-4 haematological adverse events were more common in the tucidinostat plus exemestane group than in the placebo plus exemestane group.,"[{'ForeName': 'Zefei', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'The Fifth Medical Centre of Chinese PLA General Hospital, Beijing, China. Electronic address: jiangzefei@csco.org.cn.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Xichun', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Fudan University Shanghai Cancer Centre, Shanghai, China.'}, {'ForeName': 'Qingyuan', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Sun', 'Affiliation': 'Liaoning Cancer Hospital & Institute, Shenyang, China.'}, {'ForeName': 'Shude', 'Initials': 'S', 'LastName': 'Cui', 'Affiliation': 'Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Shusen', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Sun Yat-Sen University Cancer Centre, Guangzhou, China.'}, {'ForeName': 'Quchang', 'Initials': 'Q', 'LastName': 'Ouyang', 'Affiliation': 'Hunan Cancer Hospital, Changsha, China.'}, {'ForeName': 'Yongmei', 'Initials': 'Y', 'LastName': 'Yin', 'Affiliation': 'Jiangsu Province Hospital, Nanjing, China.'}, {'ForeName': 'Cuizhi', 'Initials': 'C', 'LastName': 'Geng', 'Affiliation': 'Tumour Hospital of Hebei Province, Shijiazhuang, China.'}, {'ForeName': 'Zhongsheng', 'Initials': 'Z', 'LastName': 'Tong', 'Affiliation': 'Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Jilin Cancer Hospital, Changchun, China.'}, {'ForeName': 'Yueyin', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Anhui Provincial Hospital, Hefei, China.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Jinan Central Hospital, Jinan, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'The Third Hospital of Nanchang, Nanchang, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Ouyang', 'Affiliation': 'Beijing Cancer Hospital, Beijing, China.'}, {'ForeName': 'Kangsheng', 'Initials': 'K', 'LastName': 'Gu', 'Affiliation': 'The First Affiliated Hospital of Anui Medical University, Hefei, China.'}, {'ForeName': 'Jifeng', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Jiangsu Cancer Hospital, Nanjing, China.'}, {'ForeName': 'Xiaojia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Shubin', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Beijing University Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Tianshu', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Fudan University Zhongshan Hospital, Shanghai, China.'}, {'ForeName': 'Jinghua', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Cangzhou Central Hospital, Cangzhou, China.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Cristofanilli', 'Affiliation': 'Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Ning', 'Affiliation': 'Chipscreen Biosciences, Shenzhen, China.'}, {'ForeName': 'Xianping', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'Chipscreen Biosciences, Shenzhen, China.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30164-0']
1298,31707181,Modified gemcitabine and oxaliplatin or gemcitabine + cisplatin in unresectable gallbladder cancer: Results of a phase III randomised controlled trial.,"AIM


To determine equivalence of modified gemcitabine and oxaliplatin compared with gemcitabine and cisplatin in unresectable gallbladder cancer (GBC). Primary end-point was overall survival (OS).
METHODS


Open label, prospective, randomised phase III equivalence study. Inclusion criteria included histologically proven unresectable GBC, 18 years or older, adequate organ functions and Eastern Cooperative Oncology Group ≤2.
SAMPLE SIZE


108 patients were required in each arm to have an equivalence margin of ±2 months with power of 80%.
TREATMENT


Modified gemcitabine and oxaliplatin (mGemOx)-gemcitabine 900 mg/m2, oxaliplatin 80 mg/m2, maximum 6 cycles; gemcitabine + cisplatin (CisGem)-gemcitabine 1000 mg/m2, cisplatin 25 mg/m2, maximum 8 cycles, all day 1 and 8 every 3 weeks.
RESULTS


Two hundred sixty subjects were recruited between February 2011 and July 2015. Two hundred forty-three patients (119, mGemOx and 124, CisGem) received at least 1 dose and analysed for safety and efficacy (modified intention to treat). Median OS was 8·5 months for whole group (95% confidence interval [CI]: 7·9-9·1). Median OS in mGemOx was 9 months and 8·3 months in CisGem; p = 0·057 (hazard ratio = 0·78; 95% CI = 0·60-1·02). Restricted mean OS for follow-up limited to 30 months was 11·2 months (95% CI: 9·8-12·6) in mGemOx and 10·4 months (95% CI: 9·1-11·7) in CisGem. Difference of the mean was 0·8 months with 95% CI, exceeding 2 months (-1·1 to 2·7), hence rejecting equivalence. Peripheral neuropathy, thrombocytopaenia in mGemOx and nephrotoxicity was higher with CisGem.
CONCLUSION


This trial failed to show equivalence of eight cycles of CisGem to six cycles of mGemOx. Numerically OS was better with mGemOx. Toxicities were different. The trial was not powered to answer superiority.
CLINICAL TRIAL REGISTRATION


CTRI/2010/091/001406.",2019,Median OS in mGemOx was 9 months and 8·3 months in CisGem; p = 0·057,"['Two hundred sixty subjects were recruited between February 2011 and July 2015', 'unresectable gallbladder cancer', 'Inclusion criteria included histologically proven unresectable GBC, 18 years or older, adequate organ functions and Eastern Cooperative Oncology Group ≤2', 'unresectable gallbladder cancer (GBC', 'Two hundred forty-three patients (119, mGemOx and 124, CisGem']","['gemcitabine and oxaliplatin', 'gemcitabine and cisplatin', 'gemcitabine + cisplatin (CisGem)-gemcitabine 1000 mg/m2, cisplatin', 'mGemOx)-gemcitabine 900 mg/m2, oxaliplatin', 'modified gemcitabine and oxaliplatin', 'Modified gemcitabine and oxaliplatin or gemcitabine + cisplatin']","['Peripheral neuropathy, thrombocytopaenia in mGemOx and nephrotoxicity', 'Median OS in mGemOx', 'Toxicities', 'overall survival (OS', 'Median OS']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0153452', 'cui_str': 'Cancer of Gallbladder'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C4057589', 'cui_str': 'gemcitabine 1000 MG'}, {'cui': 'C4517900', 'cui_str': '900 (qualifier value)'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}, {'cui': 'C0599918', 'cui_str': 'Nephrotoxicity'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",260.0,0.107962,Median OS in mGemOx was 9 months and 8·3 months in CisGem; p = 0·057,"[{'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Department of Medical Oncology, Dr BRA IRCH, AIIMS, New Delhi 110029, India. Electronic address: Atul1@hotmail.com.'}, {'ForeName': 'Bidhu', 'Initials': 'B', 'LastName': 'Kalyan Mohanti', 'Affiliation': 'Department of Radiation Oncology, Dr BRA IRCH, AIIMS, New Delhi 110029, India. Electronic address: drbkmohanti@gmail.com.'}, {'ForeName': 'Surendra', 'Initials': 'S', 'LastName': 'Pal Chaudhary', 'Affiliation': 'Department of Medical Oncology, Dr BRA IRCH, AIIMS, New Delhi 110029, India. Electronic address: Drsurendra101@gmail.com.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Sreenivas', 'Affiliation': 'Department of Biostatistics, AIIMS, New Delhi 110029, India. Electronic address: sreevishnubhatla@gmail.com.'}, {'ForeName': 'Ranjit', 'Initials': 'R', 'LastName': 'Kumar Sahoo', 'Affiliation': 'Department of Medical Oncology, Dr BRA IRCH, AIIMS, New Delhi 110029, India. Electronic address: drranjitmd@gmail.com.'}, {'ForeName': 'Nootan', 'Initials': 'N', 'LastName': 'Kumar Shukla', 'Affiliation': 'Department of Surgical Oncology, Dr BRA IRCH, AIIMS, New Delhi 110029, India. Electronic address: Nkshukla2@yahoo.com.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Thulkar', 'Affiliation': 'Department of Radio Diagnosis, Dr BRA IRCH, AIIMS, New Delhi 110029, India. Electronic address: sanjaythulkar@gmail.com.'}, {'ForeName': 'Sujoy', 'Initials': 'S', 'LastName': 'Pal', 'Affiliation': 'Department of Gastrointestinal Surgery and Liver Transplantation, AIIMS, New Delhi 110029, India. Electronic address: sujoypal@hotmail.com.'}, {'ForeName': 'Surya V', 'Initials': 'SV', 'LastName': 'Deo', 'Affiliation': 'Department of Surgical Oncology, Dr BRA IRCH, AIIMS, New Delhi 110029, India. Electronic address: svsdeo@yahoo.co.in.'}, {'ForeName': 'Sushmita', 'Initials': 'S', 'LastName': 'Pathy', 'Affiliation': 'Department of Radiation Oncology, Dr BRA IRCH, AIIMS, New Delhi 110029, India. Electronic address: drspathy@gmail.com.'}, {'ForeName': 'Nihar', 'Initials': 'N', 'LastName': 'Ranjan Dash', 'Affiliation': 'Department of Gastrointestinal Surgery and Liver Transplantation, AIIMS, New Delhi 110029, India. Electronic address: nagranjan@gmail.com.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Department of Surgical Oncology, Dr BRA IRCH, AIIMS, New Delhi 110029, India. Electronic address: Dr_sunilk@hotmail.com.'}, {'ForeName': 'Sushma', 'Initials': 'S', 'LastName': 'Bhatnagar', 'Affiliation': 'Department of Onco-anaesthesia and Palliative Medicine, Dr BRA IRCH, AIIMS, New Delhi, 110029, India. Electronic address: sushmabhatnagar1@gmail.com.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Professor Department of Nuclear Medicine, AIIMS, New Delhi, 110029, India. Electronic address: rkphulia@yahoo.com.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Mishra', 'Affiliation': 'Professor Department of Nuclear Medicine, AIIMS, New Delhi, 110029, India. Electronic address: seemamishra2003@gmail.com.'}, {'ForeName': 'Peush', 'Initials': 'P', 'LastName': 'Sahni', 'Affiliation': 'Department of Gastrointestinal Surgery and Liver Transplantation, AIIMS, New Delhi 110029, India. Electronic address: peush_sahni@hotmail.com.'}, {'ForeName': 'Venkateswaran K', 'Initials': 'VK', 'LastName': 'Iyer', 'Affiliation': 'Department of Pathology, AIIMS, New Delhi 110029, India. Electronic address: iyervenkat4@gmail.com.'}, {'ForeName': 'Vinod', 'Initials': 'V', 'LastName': 'Raina', 'Affiliation': 'Department of Medical Oncology, Dr BRA IRCH, AIIMS, New Delhi 110029, India. Electronic address: vinodraina@hotmail.com.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.10.004']
1299,30730816,Diaphragm shear modulus reflects transdiaphragmatic pressure during isovolumetric inspiratory efforts and ventilation against inspiratory loading.,"The reference method for the assessment of diaphragm function relies on the measurement of transdiaphragmatic pressure (Pdi). Local muscle stiffness measured using ultrafast shear wave elastography (SWE) provides reliable estimates of muscle force in locomotor muscles. This study aimed at investigating whether SWE could be used as a surrogate of Pdi to evaluate diaphragm function. Fifteen healthy volunteers underwent a randomized stepwise inspiratory loading protocol of 0-60% of maximal isovolumetric inspiratory pressure during closed-airways maneuvers and 0-50% during ventilation against an external inspiratory threshold load. During all tasks, Pdi was measured and SWE was used to assess shear modulus of the right hemidiaphragm (SMdi) at the zone of apposition. Pearson correlation coefficients ( r) and repeated-measures correlation coefficients ( R) were computed to determine within-individual and overall relationships between Pdi and SMdi, respectively. During closed-airways maneuvers, mean Pdi correlated to mean SMdi in all participants [ r ranged from 0.77 to 0.96, all P < 0.01; R = 0.82, 95% confidence intervals (0.76, 0.86), P < 0.01]. During ventilation against inspiratory threshold loading, Pdi swing correlated to maximal SMdi in all participants [ r ranged from 0.40 to 0.90, all P < 0.01; R = 0.70, 95% confidence intervals (0.66, 0.73), P < 0.001]. Changes in diaphragm stiffness as assessed by SWE reflect changes in transdiaphragmatic pressure. SWE provides a new opportunity for direct and noninvasive assessment of diaphragm function. NEW & NOTEWORTHY Accurate and specific estimation of diaphragm effort is critical for evaluating and monitoring diaphragm dysfunction. The measurement of transdiaphragmatic pressure requires the use of invasive gastric and esophageal probes. In the present work, we demonstrate that changes in diaphragm stiffness assessed with ultrasound shear wave elastography reflect changes in transdiaphragmatic pressure, therefore offering a new noninvasive method for gauging diaphragm effort.",2019,Local muscle stiffness measured using ultrafast shear wave elastography (SWE) provides reliable estimates of muscle force in locomotor muscles.,['Fifteen healthy volunteers'],"['ultrafast shear wave elastography (SWE', 'SWE', 'randomized stepwise inspiratory loading protocol of 0-60% of maximal isovolumetric inspiratory pressure during closed-airways maneuvers and 0-50% during ventilation against an external inspiratory threshold load']","['diaphragm stiffness', 'transdiaphragmatic pressure (Pdi', 'transdiaphragmatic pressure']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1955928', 'cui_str': 'Elastography'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}]","[{'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0205504', 'cui_str': 'Transdiaphragmatic approach (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",15.0,0.0357297,Local muscle stiffness measured using ultrafast shear wave elastography (SWE) provides reliable estimates of muscle force in locomotor muscles.,"[{'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Bachasson', 'Affiliation': 'Neuromuscular Physiology Laboratory, Neuromuscular Investigation Center, Institute of Myology , Paris , France.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Dres', 'Affiliation': 'Service de Pneumologie, Médecine Intensive et Réanimation (Département ""R3S""), Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Assistance Publique-Hôpitaux de Paris, Paris , France.'}, {'ForeName': 'Marie-Cécile', 'Initials': 'MC', 'LastName': 'Niérat', 'Affiliation': 'UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Sorbonne Université, Institut National de la Santé et de la Recherche Médicale , Paris , France.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Gennisson', 'Affiliation': 'Imagerie par Résonance Magnétique Médicale et Multi-Modalités, Centre National de la Recherche Scientifique UMR8081, Université Paris-Saclay , Orsay , France.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Hogrel', 'Affiliation': 'Neuromuscular Physiology Laboratory, Neuromuscular Investigation Center, Institute of Myology , Paris , France.'}, {'ForeName': 'Jonne', 'Initials': 'J', 'LastName': 'Doorduin', 'Affiliation': 'Department of Neurology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center , Nijmegen , The Netherlands.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Similowski', 'Affiliation': 'Service de Pneumologie, Médecine Intensive et Réanimation (Département ""R3S""), Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Assistance Publique-Hôpitaux de Paris, Paris , France.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.01060.2018']
1300,31642928,Stepped Care Internet-Delivered vs Face-to-Face Cognitive-Behavior Therapy for Pediatric Obsessive-Compulsive Disorder: A Trial Protocol for a Randomized Noninferiority Trial.,"Importance


Internet-delivered cognitive behavior therapy is an effective treatment for children and adolescents with obsessive-compulsive disorder and has the potential to markedly increase access to treatment for patients while being cost-effective for health care organizations.
Objective


To investigate whether internet-delivered cognitive behavior therapy implemented within a stepped care model is noninferior to, and cost-effective compared with, the gold standard of face-to-face cognitive behavior therapy for pediatric obsessive-compulsive disorder.
Design, Setting, and Participants


Multicenter, single-blind, randomized clinical noninferiority trial implemented at 2 specialist pediatric obsessive-compulsive disorder clinics in Stockholm and Gothenburg, Sweden. Participants are 152 children and adolescents aged 7 to 17 years with obsessive compulsive disorder, recruited through the 2 clinics and online self-referral. Patients will be randomized 1:1 to the stepped care intervention or face-to-face therapy. Blind evaluations will be conducted after treatment and at 3-month and 6-month follow-ups. At the 6-month follow-up (primary end point), noninferiority will be tested and resource use will be compared between the 2 treatment groups. Data will be analyzed according to intention-to-treat principles.
Intervention


Patients randomized to stepped care will first receive internet-delivered cognitive behavior therapy for 16 weeks; patients who are classified as nonresponders 3 months after treatment completion will receive additional face-to-face therapy. The control group will receive 16 weeks of face-to-face cognitive behavior therapy immediately following randomization and nonresponders at the 3-month follow-up will, as in the stepped care group, receive additional face-to-face therapy.
Main Outcomes and Measures


Noninferiority is defined as a 4-point difference on the primary outcome measure (Children's Yale-Brown Obsessive Compulsive Scale).
Discussion


Recruitment started October 6, 2017, and was completed May 24, 2019. Results from the primary end point will be available by May 2020. The naturalistic follow-ups (1, 2, and 5 years after the end of treatment) will continue to 2025. There are no interim analyses planned or stopping rules for the trial.
Trial Registration


ClinicalTrials.gov identifier: NCT03263546.",2019,"Importance


Internet-delivered cognitive behavior therapy is an effective treatment for children and adolescents with obsessive-compulsive disorder and has the potential to markedly increase access to treatment for patients while being cost-effective for health care organizations.
","['pediatric obsessive-compulsive disorder', '2 specialist pediatric obsessive-compulsive disorder clinics in Stockholm and Gothenburg, Sweden', 'Pediatric Obsessive-Compulsive Disorder', '152 children and adolescents aged 7 to 17 years with obsessive compulsive disorder, recruited through the 2 clinics and online self-referral', 'children and adolescents with obsessive-compulsive disorder']","['stepped care intervention or face-to-face therapy', 'stepped care will first receive internet-delivered cognitive behavior therapy', 'stepped care group, receive additional face-to-face therapy', 'Stepped Care Internet-Delivered vs Face-to-Face Cognitive-Behavior Therapy', 'internet-delivered cognitive behavior therapy', 'Importance\n\n\nInternet-delivered cognitive behavior therapy', 'gold standard of face-to-face cognitive behavior therapy']","[""primary outcome measure (Children's Yale-Brown Obsessive Compulsive Scale""]","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0028768', 'cui_str': 'Anankastic Personality'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0237824', 'cui_str': 'Self-referral (procedure)'}]","[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0678579', 'cui_str': 'Brown'}, {'cui': 'C0222045'}]",152.0,0.0981064,"Importance


Internet-delivered cognitive behavior therapy is an effective treatment for children and adolescents with obsessive-compulsive disorder and has the potential to markedly increase access to treatment for patients while being cost-effective for health care organizations.
","[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Aspvall', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Andersson', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Lenhard', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Melin', 'Affiliation': 'Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Norlin', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Child and Adolescent Psychiatry Specialized Unit, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Wallin', 'Affiliation': 'Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Silverberg-Mörse', 'Affiliation': 'Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden.'}, {'ForeName': 'Inna', 'Initials': 'I', 'LastName': 'Feldman', 'Affiliation': ""Department of Women's and Children's Health, Uppsala Universitet, Uppsala, Sweden.""}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Bottai', 'Affiliation': 'Institute of Environmental Medicine, Biostatistics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mataix-Cols', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Serlachius', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.13810']
1301,31642930,Effect of Frequency of Changing Point-of-Use Reminder Signs on Health Care Worker Hand Hygiene Adherence: A Cluster Randomized Clinical Trial.,"Importance


Although hand hygiene (HH) is considered the most effective strategy for preventing hospital-acquired infections, HH adherence rates remain poor.
Objective


To examine whether the frequency of changing reminder signs affects HH adherence among health care workers.
Design, Setting, and Participants


This cluster randomized clinical trial in 9 US Department of Veterans Affairs acute care hospitals randomly assigned 58 inpatient units to 1 of 3 schedules for changing signs designed to promote HH adherence among health care workers: (1) no change; (2) weekly; and (3) monthly. Hand hygiene rates among health care workers were documented at entry and exit to patient rooms during the baseline period from October 1, 2014, to March 31, 2015, of normal signage and throughout the intervention period of June 8, 2015, to December 28, 2015. Data analyses were conducted in April 2018.
Interventions


Hospital units were randomly assigned into 3 groups: (1) no sign changes throughout the intervention period, (2) signs changed weekly, and (3) signs changed monthly.
Main Outcomes and Measures


Hand hygiene adherence as measured by covert observation. Interrupted time series analysis was used to examine changes in HH adherence from baseline through the intervention period by group.
Results


Among 58 inpatient units, 19 units were assigned to the no change group, 19 units were assigned to the weekly change group, and 20 units were assigned to the monthly change group. During the baseline period, 9755 HH opportunities were observed at room entry and 10 095 HH opportunities were observed at room exit. During the intervention period, a total of 15 855 HH opportunities were observed at room entry, and 16 360 HH opportunities were observed at room exit. Overall HH adherence did not change from baseline compared with the intervention period at either room entry (4770 HH events [48.9%] vs 3057 HH events [50.1%]; P = .14) or exit (6439 HH events [63.8%] vs 4087 HH events [65.2%]; P = .06). In units that changed signs weekly, HH adherence declined from baseline at room entry (-1.9% [95% CI, -2.7% to -0.8%] per week; P < .001) and exit (-0.8% [95% CI, -1.5% to 0.1%] per week; P = .02). No significant changes in HH adherence were observed in other groups.
Conclusions and Relevance


The frequency of changing reminder signs had no effect on HH rates overall. Units assigned to change signs most frequently demonstrated worsening adherence. Considering the abundance of signs in the acute care environment, the frequency of changing signs did not appear to provide a strong enough cue by itself to promote behavioral change.
Trial Registration


ClinicalTrials.gov Identifier: NCT02223455.",2019,"In units that changed signs weekly, HH adherence declined from baseline at room entry (-1.9% [95% CI, -2.7% to -0.8%] per week; P < .001) and exit (-0.8% [95% CI, -1.5% to 0.1%] per week; P = .02).","[' 19 units were assigned to the no change group, 19 units were assigned to the weekly change group, and 20 units were assigned to the monthly change group', 'health care workers', 'Veterans Affairs acute care hospitals randomly assigned 58 inpatient units to 1 of', 'Interventions\n\n\nHospital units', '58 inpatient units']",['3 schedules for changing signs designed to promote HH adherence among health care workers'],"['HH adherence', 'Overall HH adherence', 'worsening adherence', 'Health Care Worker Hand Hygiene Adherence', 'Measures\n\n\nHand hygiene adherence']","[{'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0442739', 'cui_str': 'Id status quo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C3661916', 'cui_str': 'Acute care hospital'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0019988', 'cui_str': 'Hospital Units'}]","[{'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}]",58.0,0.0599596,"In units that changed signs weekly, HH adherence declined from baseline at room entry (-1.9% [95% CI, -2.7% to -0.8%] per week; P < .001) and exit (-0.8% [95% CI, -1.5% to 0.1%] per week; P = .02).","[{'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Vander Weg', 'Affiliation': 'Center for Access and Delivery Research and Evaluation, Iowa City VA Health Care System, Iowa City, Iowa.'}, {'ForeName': 'Eli N', 'Initials': 'EN', 'LastName': 'Perencevich', 'Affiliation': 'Center for Access and Delivery Research and Evaluation, Iowa City VA Health Care System, Iowa City, Iowa.'}, {'ForeName': 'Amy M J', 'Initials': 'AMJ', 'LastName': ""O'Shea"", 'Affiliation': 'Center for Access and Delivery Research and Evaluation, Iowa City VA Health Care System, Iowa City, Iowa.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Jones', 'Affiliation': 'Center for Access and Delivery Research and Evaluation, Iowa City VA Health Care System, Iowa City, Iowa.'}, {'ForeName': 'Mary S', 'Initials': 'MS', 'LastName': 'Vaughan Sarrazin', 'Affiliation': 'Center for Access and Delivery Research and Evaluation, Iowa City VA Health Care System, Iowa City, Iowa.'}, {'ForeName': 'Carrie L', 'Initials': 'CL', 'LastName': 'Franciscus', 'Affiliation': 'Center for Access and Delivery Research and Evaluation, Iowa City VA Health Care System, Iowa City, Iowa.'}, {'ForeName': 'Cassie Cunningham', 'Initials': 'CC', 'LastName': 'Goedken', 'Affiliation': 'Center for Access and Delivery Research and Evaluation, Iowa City VA Health Care System, Iowa City, Iowa.'}, {'ForeName': 'Gio J', 'Initials': 'GJ', 'LastName': 'Baracco', 'Affiliation': 'Miami VA Healthcare System, Miami, Florida.'}, {'ForeName': 'Suzanne F', 'Initials': 'SF', 'LastName': 'Bradley', 'Affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Cadena', 'Affiliation': 'South Texas Veterans Health Care System, San Antonio.'}, {'ForeName': 'Graeme N', 'Initials': 'GN', 'LastName': 'Forrest', 'Affiliation': 'VA Portland Health Care System, Portland, Oregon.'}, {'ForeName': 'Kalpana', 'Initials': 'K', 'LastName': 'Gupta', 'Affiliation': 'VA Boston Healthcare System, Boston, Massachusetts.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Morgan', 'Affiliation': 'VA Maryland Health Care System, Baltimore.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Rubin', 'Affiliation': 'VA Salt Lake City Health Care System, Salt Lake City, Utah.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Thurn', 'Affiliation': 'Minneapolis VA Medical Center, Minneapolis, Minnesota.'}, {'ForeName': 'Marvin J', 'Initials': 'MJ', 'LastName': 'Bittner', 'Affiliation': 'Nebraska-Western Iowa Veterans Affairs Health Care System, Omaha, Nebraska.'}, {'ForeName': 'Heather Schacht', 'Initials': 'HS', 'LastName': 'Reisinger', 'Affiliation': 'Center for Access and Delivery Research and Evaluation, Iowa City VA Health Care System, Iowa City, Iowa.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.13823']
1302,31853105,Comparing the sodium excreting efficacy of furosemide and indapamide combination against furosemide and metolazone combination in congestive heart failure patients: A randomized control trial.,"Objective


To compare efficacy and safety of indapamide-furosemide combination against metolazone-furosemide combination in refractory heart failure patients.
METHODS


The randomised controlled trial was conducted at Rehman Medical Institute, Peshawar, Pakistan, from January 1 to June 30, 2018, and comprised refractory heart failure patients who were randomised into two groups using lottery method Group 1 received intravenous furosemide 40mg Q12hr with metolazone 5mg Q24hr, while group 2 received intravenous furosemide 40mg Q12hr with indapamide 2.5mg Q24hr. Both groups were assessed for urinary sodium excretion, total urine output and decrease in weight on day one, day three and day five of admission. SPSS 22 was used for data analysis.
RESULTS


Of the 150 patients, there were 75(50%) in each of the two groups. Mean age in group 1 was 64.8}11.2 years, while it was 66.3}12.9 years in group 2. Both groups showed increased urinary sodium excretion and total urine output (p>0.05). Hypokalaemia was the most common adverse event 66%. Mean hospital stay was not significantly different between the groups (p>0.05).
CONCLUSIONS


There was no significant differences between adverse events and efficacy between patients receiving either indapamide-furosemide combination or metolazone-furosemide combination.",2019,There was no significant differences between adverse events and efficacy between patients receiving either indapamide-furosemide combination or metolazone-furosemide combination.,"['150 patients', 'refractory heart failure patients', 'congestive heart failure patients', 'Rehman Medical Institute, Peshawar, Pakistan, from January 1 to June 30, 2018, and comprised refractory heart failure patients']","['furosemide and indapamide combination against furosemide and metolazone combination', 'indapamide-furosemide combination against metolazone-furosemide combination', 'indapamide-furosemide combination or metolazone-furosemide combination', 'intravenous furosemide 40mg Q12hr with metolazone 5mg Q24hr, while group 2 received intravenous furosemide 40mg Q12hr with indapamide 2.5mg Q24hr']","['Hypokalaemia', 'urinary sodium excretion and total urine output', 'Mean hospital stay', 'adverse events and efficacy', 'efficacy and safety', 'urinary sodium excretion, total urine output and decrease in weight']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1281998', 'cui_str': 'Refractory heart failure'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure (disorder)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}]","[{'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0021186', 'cui_str': 'Indapamide'}, {'cui': 'C0025854', 'cui_str': 'Metolazone'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0986199', 'cui_str': 'Furosemide 40 MG'}, {'cui': 'C0987840', 'cui_str': 'Metolazone 5 MG'}, {'cui': 'C1275548', 'cui_str': 'q24hr'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0986685', 'cui_str': 'Indapamide 2.5 MG'}]","[{'cui': 'C0020621', 'cui_str': 'Hypopotassemia'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1287298', 'cui_str': 'UO - Urine output'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",,0.062386,There was no significant differences between adverse events and efficacy between patients receiving either indapamide-furosemide combination or metolazone-furosemide combination.,"[{'ForeName': 'Momin', 'Initials': 'M', 'LastName': 'Salahudin', 'Affiliation': 'Department of Cardiology, Rehman Medical Institute Peshawar, Pakistan.'}, {'ForeName': 'Hammad', 'Initials': 'H', 'LastName': 'Shah', 'Affiliation': 'Department of Cardiology, Rehman Medical Institute Peshawar, Pakistan.'}, {'ForeName': 'Muneeb Ullah', 'Initials': 'MU', 'LastName': 'Jan', 'Affiliation': 'Department of Medicine, Rehman Medical Institute Peshawar, Pakistan.'}, {'ForeName': 'Afrasyab', 'Initials': 'A', 'LastName': 'Altaf', 'Affiliation': 'Department of Cardiology, Rehman Medical Institute Peshawar, Pakistan.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.3401']
1303,31853116,Effectiveness of standardized patient on patient education skills of nursing students - a pilot study.,"Objective


To determine the effectiveness of simulation method in nursing education. .
METHODS


The experimental study was conducted from February 2013 to January 2014 at the Nursing Faculty of Ege University, Izmir, Turkey, and comprised second-year students. The subjects were randomly assigned to experimental or control groups. The experimental group participated in a simulation laboratory that involved the use of a standardized patient. Data was collected and analysed using SPSS 20.
RESULTS


Of the 66 subjects, with a mean age of 20}1.05 years, 62(93.9%) were females and 4(6.1%) were males. There were 32(48.5%) subjects in the experimental group and 34(51.5%) in the control group. There was no statistically significant difference between the groups in the mean scores obtained on the pretest, posttest ( and retention test (p>0.05 each). However, experimental group had higher mean retention test scores (1.90}1.96).
CONCLUSIONS


The knowledge levels of both groups increased, but lack of significant difference between the scores shows that both methods are successful.",2019,"There was no statistically significant difference between the groups in the mean scores obtained on the pretest, posttest ( and retention test (p>0.05 each).","['February 2013 to January 2014 at the Nursing Faculty of Ege University, Izmir, Turkey, and comprised second-year students', 'Of the 66 subjects, with a mean age of 20}1.05 years, 62(93.9%) were females and 4(6.1%) were males']",['standardized patient'],"['mean retention test scores', 'knowledge levels', 'patient education skills']","[{'cui': 'C0015538', 'cui_str': 'Faculty, Nursing'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0041400', 'cui_str': 'Turkey'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0871796', 'cui_str': 'Knowledge level'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}]",66.0,0.0230549,"There was no statistically significant difference between the groups in the mean scores obtained on the pretest, posttest ( and retention test (p>0.05 each).","[{'ForeName': 'Hale', 'Initials': 'H', 'LastName': 'Sezer', 'Affiliation': 'Department of Nursing Education, Ege University, Turkey.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Orgun', 'Affiliation': 'Department of Nursing Education, Ege University, Turkey.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.1590']
1304,30987939,"Abiraterone acetate plus prednisone in patients with newly diagnosed high-risk metastatic castration-sensitive prostate cancer (LATITUDE): final overall survival analysis of a randomised, double-blind, phase 3 trial.","BACKGROUND


In the interim analyses of the LATITUDE study, the addition of abiraterone acetate plus prednisone to androgen deprivation therapy (ADT) led to a significant improvement in overall survival and radiographic progression-free survival compared with placebos plus ADT in men with newly diagnosed high-risk metastatic castration-sensitive prostate cancer (mCSPC). Here, we present long-term survival outcomes and safety of abiraterone acetate plus prednisone and ADT from the final analysis of the LATITUDE study.
METHODS


This is a multicentre, randomised, double-blind, phase 3 trial done at 235 sites in 34 countries. Eligible patients (men aged ≥18 years) had newly diagnosed, histologically or cytologically confirmed prostate cancer with metastases, Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, and at least two of the three high-risk prognostic factors (Gleason score of ≥8, presence of three or more lesions on bone scan, or presence of measurable visceral metastasis except lymph node metastasis). Patients were randomly assigned (1:1) to receive abiraterone acetate (1000 mg) once daily orally plus prednisone (5 mg) once daily orally and ADT (abiraterone acetate plus prednisone group) or matching placebos plus ADT (placebo group); each treatment cycle was 28 days. Randomisation was done by a centralised interactive web response system in a country-by-country scheme using permuted block randomisation, stratified by presence of visceral disease and ECOG performance status. The coprimary endpoint of overall survival was assessed in the intention-to-treat population. This study is registered at ClinicalTrials.gov, number NCT01715285 and is complete.
FINDINGS


Between Feb 12, 2013, and Dec 11, 2014, 1209 patients were screened, of whom ten were ineligible because of study site violations. 1199 patients were randomly assigned to either the abiraterone acetate plus prednisone group (n=597) or placebo group (n=602). After the results of the first interim analysis (cutoff date Oct 31, 2016), the study was unmasked to patients and investigators, and patients in the placebo group were allowed to cross over to receive abiraterone acetate and prednisone plus ADT treatment as per a protocol amendment (Feb 15, 2017) in an open-label extension phase of the study (up to 18 months from the protocol amendment). This final analysis (data cutoff Aug 15, 2018) was done after a median follow-up of 51·8 months (IQR 47·2-57·0) and 618 deaths (275 [46%] of 597 in the abiraterone acetate plus prednisone group and 343 [57%] of 602 in the placebo group). Overall survival was significantly longer in the abiraterone acetate plus prednisone group (median 53·3 months [95% CI 48·2-not reached]) than in the placebo group (36·5 months [33·5-40·0]), with a hazard ratio of 0·66 (95% CI 0·56-0·78; p<0·0001). The most common grade 3-4 adverse events were hypertension (125 [21%] in the abiraterone acetate plus prednisone group vs 60 [10%] in the placebo group vs three [4%] in the 72 patients who crossed over from placebo to abiraterone acetate plus prednisone) and hypokalaemia (70 [12%] vs ten [2%] vs two [3%]). Serious adverse events of any grade occurred in 192 (32%) of 597 patients in the abiraterone acetate plus prednisone group, 151 (25%) of 602 in the placebo group, and four (6%) of 72 in the crossover group. The most common treatment-related serious adverse event was hypokalaemia (four [1%] patients in the abiraterone acetate plus prednisone group and none in the other groups). Treatment-related deaths occurred in three (<1%) patients each in the abiraterone acetate plus prednisone group (gastric ulcer perforation, sudden death, and cerebrovascular accident) and the placebo group (sudden death, cerebrovascular accident, and pneumonia), with none in the crossover group.
INTERPRETATION


The combination of abiraterone acetate plus prednisone with ADT was associated with significantly longer overall survival than placebos plus ADT in men with newly diagnosed high-risk mCSPC and had a manageable safety profile. These findings support the use of abiraterone acetate plus prednisone as a standard of care in patients with high-risk mCSPC.
FUNDING


Janssen Research & Development.",2019,"Overall survival was significantly longer in the abiraterone acetate plus prednisone group (median 53·3 months [95% CI 48·2-not reached]) than in the placebo group (36·5 months [33·5-40·0]), with a hazard ratio of 0·66 (95% CI 0·56-0·78; p<0·0001).","['men with newly diagnosed high-risk metastatic castration-sensitive prostate cancer (mCSPC', 'men with newly diagnosed high-risk mCSPC', '235 sites in 34 countries', 'patients with newly diagnosed high-risk metastatic castration-sensitive prostate cancer (LATITUDE', 'Eligible patients (men aged ≥18 years) had newly diagnosed, histologically or cytologically confirmed prostate cancer with metastases, Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, and at least two of the three high-risk prognostic factors (Gleason score of ≥8, presence of three or more lesions on bone scan, or presence of measurable visceral metastasis except lymph node metastasis', 'Between Feb 12, 2013, and Dec 11, 2014, 1209 patients were screened, of whom ten were ineligible because of study site violations', 'patients with high-risk mCSPC', '1199 patients']","['placebos plus ADT', 'placebo to abiraterone acetate plus prednisone', 'abiraterone acetate plus prednisone', 'prednisone (5 mg) once daily orally and ADT (abiraterone acetate plus prednisone group) or matching placebos plus ADT (placebo', 'placebo', 'abiraterone acetate plus prednisone with ADT', 'abiraterone acetate and prednisone plus ADT', 'abiraterone acetate', 'abiraterone acetate plus prednisone and ADT', 'Abiraterone acetate plus prednisone', 'abiraterone acetate plus prednisone to androgen deprivation therapy (ADT']","['hypokalaemia', 'Overall survival', 'sudden death, cerebrovascular accident, and pneumonia', 'gastric ulcer perforation, sudden death, and cerebrovascular accident', 'overall survival and radiographic progression-free survival', 'deaths', 'overall survival']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C1514474', 'cui_str': 'Prognostic Factors'}, {'cui': 'C3203027', 'cui_str': 'Gleason score (observable entity)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0203668', 'cui_str': 'Radioisotope scan of bone'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C0686619', 'cui_str': 'Secondary malignant neoplasm of lymph node'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2607886', 'cui_str': 'abiraterone acetate'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}]","[{'cui': 'C0020621', 'cui_str': 'Hypopotassemia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0011071', 'cui_str': 'Sudden death (event)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0341163', 'cui_str': 'Gastric ulcer with perforation'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",1199.0,0.662238,"Overall survival was significantly longer in the abiraterone acetate plus prednisone group (median 53·3 months [95% CI 48·2-not reached]) than in the placebo group (36·5 months [33·5-40·0]), with a hazard ratio of 0·66 (95% CI 0·56-0·78; p<0·0001).","[{'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'Department of Cancer Medicine, Institut Gustave Roussy, University of Paris Sud, Villejuif, France. Electronic address: karim.fizazi@gustaveroussy.fr.'}, {'ForeName': 'NamPhuong', 'Initials': 'N', 'LastName': 'Tran', 'Affiliation': 'Janssen Research and Development, Los Angeles, CA, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Fein', 'Affiliation': 'Instituto de Oncologia de Rosário, Rosário, Argentina.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Matsubara', 'Affiliation': 'National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Rodriguez-Antolin', 'Affiliation': '12 de Octubre University Hospital, Madrid, Spain.'}, {'ForeName': 'Boris Y', 'Initials': 'BY', 'LastName': 'Alekseev', 'Affiliation': 'PA Hertsen Moscow Cancer Research Institute, Moscow, Russia.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Özgüroğlu', 'Affiliation': 'Cerrahpaşa Medical Faculty, Istanbul University Cerrahpaşa, Istanbul, Turkey.'}, {'ForeName': 'Dingwei', 'Initials': 'D', 'LastName': 'Ye', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Feyerabend', 'Affiliation': 'Studienpraxis Urologie, Nürtingen, Germany.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Protheroe', 'Affiliation': 'Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Giri', 'Initials': 'G', 'LastName': 'Sulur', 'Affiliation': 'Janssen Research and Development, Los Angeles, CA, USA.'}, {'ForeName': 'Yesenia', 'Initials': 'Y', 'LastName': 'Luna', 'Affiliation': 'Janssen Research and Development, Los Angeles, CA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Janssen Research and Development, Spring House, PA, USA.'}, {'ForeName': 'Suneel', 'Initials': 'S', 'LastName': 'Mundle', 'Affiliation': 'Janssen Research and Development, Raritan, NJ, USA.'}, {'ForeName': 'Kim N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': 'BC Cancer Agency-Vancouver Centre, Vancouver, BC, Canada.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30082-8']
1305,31695168,Intrinsic connectomes are a predictive biomarker of remission in major depressive disorder.,"Although major depressive disorder (MDD) is associated with altered functional coupling between disparate neural networks, the degree to which such measures are ameliorated by antidepressant treatment is unclear. It is also unclear whether functional connectivity can be used as a predictive biomarker of treatment response. Here, we used whole-brain functional connectivity analysis to identify neural signatures of remission following antidepressant treatment, and to identify connectomic predictors of treatment response. 163 MDD and 62 healthy individuals underwent functional MRI during pre-treatment baseline and 8-week follow-up sessions. Patients were randomized to escitalopram, sertraline or venlafaxine-XR antidepressants and assessed at follow-up for remission. Baseline measures of intrinsic functional connectivity between each pair of 333 regions were analyzed to identify pre-treatment connectomic features that distinguish remitters from non-remitters. We then interrogated these connectomic differences to determine if they changed post-treatment, distinguished patients from controls, and were modulated by medication type. Irrespective of medication type, remitters were distinguished from non-remitters by greater connectivity within the default mode network (DMN); specifically, between the DMN, fronto-parietal and somatomotor networks, the DMN and visual, limbic, auditory and ventral attention networks, and between the fronto-parietal and somatomotor networks with cingulo-opercular and dorsal attention networks. This baseline hypo-connectivity for non-remitters also distinguished them from controls and increased following treatment. In contrast, connectivity for remitters was higher than controls at baseline and also following remission, suggesting a trait-like connectomic characteristic. Increased functional connectivity within and between large-scale intrinsic brain networks may characterize acute recovery with antidepressants in depression.",2020,"Irrespective of medication type, remitters were distinguished from non-remitters by greater connectivity within the default mode network (DMN); specifically, between the DMN, fronto-parietal and somatomotor networks, the DMN and visual, limbic, auditory and ventral attention networks, and between the fronto-parietal and somatomotor networks with cingulo-opercular and dorsal attention networks.",['163 MDD and 62 healthy individuals underwent'],"['escitalopram, sertraline or venlafaxine-XR antidepressants', 'functional MRI']","['connectivity for remitters', 'intrinsic functional connectivity']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0439674', 'cui_str': 'Intrinsic (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",163.0,0.0349942,"Irrespective of medication type, remitters were distinguished from non-remitters by greater connectivity within the default mode network (DMN); specifically, between the DMN, fronto-parietal and somatomotor networks, the DMN and visual, limbic, auditory and ventral attention networks, and between the fronto-parietal and somatomotor networks with cingulo-opercular and dorsal attention networks.","[{'ForeName': 'Mayuresh S', 'Initials': 'MS', 'LastName': 'Korgaonkar', 'Affiliation': 'The Brain Dynamics Centre, Westmead Institute for Medical Research, The University of Sydney, Sydney, Australia. m.korgaonkar@sydney.edu.au.'}, {'ForeName': 'Andrea N', 'Initials': 'AN', 'LastName': 'Goldstein-Piekarski', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Fornito', 'Affiliation': 'Brain and Mental Health Research Hub, Turner Institute for Brain and Mental Health & Monash Biomedical Imaging, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Williams', 'Affiliation': 'The Brain Dynamics Centre, Westmead Institute for Medical Research, The University of Sydney, Sydney, Australia. leawilliams@stanford.edu.'}]",Molecular psychiatry,['10.1038/s41380-019-0574-2']
1306,30285092,Strength Endurance Training but Not Intensive Strength Training Reduces Senescence-Prone T Cells in Peripheral Blood in Community-Dwelling Elderly Women.,"Aging is characterized by a progressive decline in immune function known as immunosenescence. Although the causes of immunosenescence are likely to be multifactorial, an age-associated accumulation of senescent T cells and decreased naive T-cell repertoire are key contributors to the phenomenon. On the other hand, there is a growing consensus that physical exercise may improve immune response in aging. However, the optimum training modality required to obtain beneficial adaptations in older subjects is lacking. Therefore, we aimed to investigate the effects of exercise modality on T-cell phenotypes in older women. A total of 100 women (aged ≥ 65 years) were randomized to either intensive strength training (80% of one-repetition maximum ), strength endurance training (40% one-repetition maximum), or control (stretching exercise) for 2-3 times per week during 6 weeks. The T-cell percentages and absolute counts were determined using flow cytometry and a hematology analyzer. C-reactive protein was measured using immunonephelometry. We report for the first time that 6 weeks of strength endurance training significantly decreased the basal percentage and absolute counts of senescence-prone T cells, which was positively related to the number of training sessions performed. Conceivably, training protocols with many repetitions-at a sufficiently high external resistance-might assist the reduction of senescence-prone T cells in older women.",2019,"We report for the first time that 6 weeks of SET significantly decreased the basal percentage and absolute counts of senescence-prone T-cells, which was positively related to the number of training sessions performed.","['community-dwelling elderly women', '100 women (aged ≥65 years', 'older women', 'older subjects']","['intensive strength training (80% of one-repetition maximum (1RM)), strength endurance training (SET, 40% 1RM), or control (stretching exercise', 'exercise modality', 'physical exercise', 'intensive strength training', 'Strength endurance training']","['basal percentage and absolute counts of senescence-prone T-cells', 'C-reactive protein']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman (person)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0231337', 'cui_str': 'Senescence'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]",100.0,0.0185678,"We report for the first time that 6 weeks of SET significantly decreased the basal percentage and absolute counts of senescence-prone T-cells, which was positively related to the number of training sessions performed.","[{'ForeName': 'Hung', 'Initials': 'H', 'LastName': 'Cao Dinh', 'Affiliation': 'Frailty in Ageing Research Group.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Njemini', 'Affiliation': 'Frailty in Ageing Research Group.'}, {'ForeName': 'Oscar Okwudiri', 'Initials': 'OO', 'LastName': 'Onyema', 'Affiliation': 'Frailty in Ageing Research Group.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Beyer', 'Affiliation': 'Frailty in Ageing Research Group.'}, {'ForeName': 'Keliane', 'Initials': 'K', 'LastName': 'Liberman', 'Affiliation': 'Frailty in Ageing Research Group.'}, {'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'De Dobbeleer', 'Affiliation': 'Frailty in Ageing Research Group.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Renmans', 'Affiliation': 'Hematology Laboratory, Universitair Ziekenhuis Brussel, Belgium.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Vander Meeren', 'Affiliation': 'Hematology Laboratory, Universitair Ziekenhuis Brussel, Belgium.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Jochmans', 'Affiliation': 'Hematology Laboratory, Universitair Ziekenhuis Brussel, Belgium.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Delaere', 'Affiliation': 'Frailty in Ageing Research Group.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Knoop', 'Affiliation': 'Frailty in Ageing Research Group.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Bautmans', 'Affiliation': 'Frailty in Ageing Research Group.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/gly229']
1307,30993660,Effects of oxycodone applied for patient-controlled analgesia on postoperative cognitive function in elderly patients undergoing total hip arthroplasty: a randomized controlled clinical trial.,"BACKGROUND


Postoperative cognitive dysfunction (POCD) is a common complication after orthopedic surgery, which is not conducive to the prognosis of the elderly.
AIMS


We performed this study to investigate the effects of oxycodone applied for patient-controlled intravenous analgesia (PCIA) on postoperative cognitive function in elderly patients after total hip arthroplasty (THA).
METHODS


Ninety-nine participants were enrolled and allocated into two groups: oxycodone group (group O) and sufentanil group (group S). The primary outcome was the incidence of POCD, diagnosed according to the changes in the Mini-mental status examination (MMSE) and Montreal Cognitive Assessment (MoCA) scores. The secondary outcomes included the plasma levels of S-100B protein and neuron-specific enolase (NSE), the amount of postoperative analgesic consumption and the incidence of adverse reactions.
RESULTS


The incidence of POCD was significantly lower in patients receiving oxycodone up to the 3rd postoperative day (POD, 1st POD 27.3% vs. 51.1%, P = 0.021; 3rd POD 20.5% vs. 40.0%, P = 0.045), as compared to patients receiving sufentanil. The MMSE and MoCA scores of both groups decreased to varying degrees. However, compared with group S, the MMSE scores at 1st POD, 3rd POD, 5th POD and 7st POD in group O were higher than that in group S, while MoCA scores at 1st POD, 3rd POD and 5th POD in group O were higher. Compared with group S, the plasma levels of S-100B protein in group O at 4 h, 8 h, 12 h post-surgery were lower. While the plasma levels of NSE in group O at 4 h, 8 h, 12 h, 24 h post-surgery were lower. Number of PCIA boluses and consumption of analgesic drug during the first two POD were similar between two groups. However, postoperative incidence of nausea, vomiting and pruritus was significantly lower in patients receiving oxycodone.
CONCLUSION


Oxycodone applied for PCIA in elderly patients after THA could reduce the incidence of POCD, improve postoperative cognitive function and decrease the adverse reactions.",2020,"Compared with group S, the plasma levels of S-100B protein in group O at 4 h, 8 h, 12 h post-surgery were lower.","['elderly patients undergoing total hip arthroplasty', 'elderly patients', 'elderly patients after total hip arthroplasty (THA', 'Ninety-nine participants']","['sufentanil', 'patient-controlled intravenous analgesia (PCIA', 'oxycodone', 'Oxycodone']","['postoperative incidence of nausea, vomiting and pruritus', 'MMSE and MoCA scores', 'postoperative cognitive function', 'plasma levels of S-100B protein', 'plasma levels of S-100B protein and neuron-specific enolase (NSE), the amount of postoperative analgesic consumption and the incidence of adverse reactions', 'incidence of POCD', 'incidence of POCD, improve postoperative cognitive function', 'incidence of POCD, diagnosed according to the changes in the Mini-mental status examination (MMSE) and Montreal Cognitive Assessment (MoCA) scores', 'MMSE scores at 1st POD, 3rd POD, 5th POD and 7st POD', 'MoCA scores', 'Number of PCIA boluses and consumption of analgesic drug', 'adverse reactions', 'plasma levels of NSE']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C3828813', 'cui_str': 'Ninety-nine'}]","[{'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3658228', 'cui_str': 'NTP-S-100beta'}, {'cui': 'C1880904', 'cui_str': 'Nervous System-Specific Enolase'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205435', 'cui_str': 'First (qualifier value)'}, {'cui': 'C0205437', 'cui_str': 'Third (qualifier value)'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",99.0,0.0380066,"Compared with group S, the plasma levels of S-100B protein in group O at 4 h, 8 h, 12 h post-surgery were lower.","[{'ForeName': 'Jianhui', 'Initials': 'J', 'LastName': 'Gan', 'Affiliation': ""Department of Anesthesiology, Tangshan People's Hospital, North China University of Science and Technology, Tangshan, 063000, China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Tu', 'Affiliation': ""Department of Anesthesiology, Tangshan People's Hospital, North China University of Science and Technology, Tangshan, 063000, China.""}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Miao', 'Affiliation': 'Xuzhou Medical University, Xuzhou, 221000, Jiangsu, China.'}, {'ForeName': 'Tiantian', 'Initials': 'T', 'LastName': 'Lei', 'Affiliation': 'Department of Anesthesiology, The Second Hospital of Hebei Medical University, Shijiazhuang, 050000, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Cui', 'Affiliation': ""Department of Anesthesiology, Tangshan People's Hospital, North China University of Science and Technology, Tangshan, 063000, China.""}, {'ForeName': 'Jinyin', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': ""Department of Breast Surgery, Tangshan People's Hospital, North China University of Science and Technology, Tangshan, 063000, China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, The Third People's Hospital of Chengdu, Southwest Jiao Tong University, No. 82 Qinglong Street, Chengdu, 610031, Sichuan, China. zhangjianchengdu@163.com.""}]",Aging clinical and experimental research,['10.1007/s40520-019-01202-w']
1308,31718281,Comparative evaluation of corneal incision enlargement after intraocular lens delivery of new preloaded and manual implantation systems.,"PURPOSE


To determine whether total corneal incision enlargement after implantation of an intraocular lens with a new preloaded delivery system is comparable to a standard-of-care manual delivery system using an in vitro human cadaver eye model, despite having a smaller initial incision size.
METHODS


Human cadaver phakic whole eye globes were used for these studies (n = 16 per group). Each pair of eyes was randomly assigned to a new preloaded delivery system (UltraSert TM ) or a manual delivery system (MONARCH ®  III D). The surgical procedure included creating a 2.2- and 2.4-mm corneal incision for the preloaded and manual delivery systems, respectively, measuring intraocular pressure and pre-implantation corneal incision size, delivering the intraocular lens into the anterior chamber, and measuring the post-implantation incision size.
RESULTS


The final corneal incision enlargement after intraocular lens delivery using the preloaded delivery system was 2.33 ± 0.04 mm, compared to 2.54 ± 0.05 mm after intraocular lens delivery with the manual delivery system. The mean corneal incision enlargement was comparable between the two systems, being 0.13 ± 0.04 mm using the preloaded delivery system and 0.14 ± 0.05 mm using the manual delivery system (p = 0.432).
CONCLUSION


In a human cadaver eye model, the preloaded delivery system demonstrated an intraocular lens delivery performance on cornea incision enlargement was noninferior to the manual, standard-of-care intraocular lens delivery system despite a smaller initial incision size.
TRANSLATIONAL RELEVANCE


Smaller incision sizes for cataract surgery improve patient outcomes via faster visual and wound recovery and decreased risk of complications such as postoperative inflammation and surgically induced astigmatism.",2019,"TRANSLATIONAL RELEVANCE


Smaller incision sizes for cataract surgery improve patient outcomes via faster visual and wound recovery and decreased risk of complications such as postoperative inflammation and surgically induced astigmatism.",['Human cadaver phakic whole eye globes were used for these studies (n\u2009=\u200916 per group'],['new preloaded delivery system (UltraSert TM ) or a manual delivery system (MONARCH ®  III D'],"['final corneal incision enlargement', 'mean corneal incision enlargement']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0006629', 'cui_str': 'Corpse'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0449914', 'cui_str': 'Delivery system (attribute)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C1293134', 'cui_str': 'Enlargement procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0162799,"TRANSLATIONAL RELEVANCE


Smaller incision sizes for cataract surgery improve patient outcomes via faster visual and wound recovery and decreased risk of complications such as postoperative inflammation and surgically induced astigmatism.","[{'ForeName': 'Lixin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Global Ophthalmology Development, Novartis Pharmaceuticals Corporation, Fort Worth, Texas, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Wolfe', 'Affiliation': 'Surgical Product Development, Alcon Vision, LLC, Fort Worth, Texas, USA.'}, {'ForeName': 'Sumit', 'Initials': 'S', 'LastName': 'Paliwal', 'Affiliation': 'Surgical Product Development, Alcon Vision, LLC, Fort Worth, Texas, USA.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Chernosky', 'Affiliation': 'Surgical Product Development, Alcon Vision, LLC, Fort Worth, Texas, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kohnen', 'Affiliation': 'Department of Ophthalmology, Goethe University Frankfurt, Frankfurt, Germany.'}]",European journal of ophthalmology,['10.1177/1120672119882334']
1309,31725463,The Effect of Foregrounding Intended Use on Observers' Ratings and Comments in the Assessment of Clinical Competence.,"PURPOSE


Some educational programs have adopted the premise that the same assessment can serve both formative and summative goals; however, how observers understand and integrate the intended uses of assessment may affect the way they execute the assessment task. The objective of this study was to explore the effect of foregrounding a different intended use (formative vs summative learner assessment) on observer contributions (ratings and comments).
METHOD


In this randomized, experimental, between-groups, mixed-methods study (May-September 2017), participants observed 3 prerecorded clinical performances under formative or summative assessment conditions. Participants rated performances using a global rating tool and provided comments. Participants were then asked to reconsider their ratings from the alternative perspective (from which they were originally blinded). They received the opportunity to alter their ratings and comments and to provide rationales for their decision to change or preserve their original ratings and comments. Outcomes included participant-observers' comments, ratings, changes to each, and stated rationales for changing or preserving their contributions.
RESULTS


Foregrounding different intended uses of assessment data for participant-observers did not result in differences in ratings, number or type of comments (both emphasized evaluative over constructive statements), or the ability to differentiate among performances. After adopting the alternative perspective, participant-observers made only small changes in ratings or comments. Participant-observers reported that they engage in the process in an evaluative manner despite different intended uses.
CONCLUSIONS


Foregrounding different intended uses for assessments did not result in significant systematic differences in the assessment data generated. Observers provided more evaluative than constructive statements overall, regardless of the intended use of the assessment. Future research is needed to explore whether these results hold in social/workplace-based contexts and how they might affect learners.",2020,"RESULTS


Foregrounding different intended uses of assessment data for participant-observers did not result in differences in ratings, number or type of comments (both emphasized evaluative over constructive statements), or the ability to differentiate among performances.",[],[],"[""participant-observers' comments, ratings, changes to each, and stated rationales for changing or preserving contributions""]",[],[],"[{'cui': 'C0282411', 'cui_str': 'Commentary'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}]",,0.0538927,"RESULTS


Foregrounding different intended uses of assessment data for participant-observers did not result in differences in ratings, number or type of comments (both emphasized evaluative over constructive statements), or the ability to differentiate among performances.","[{'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Tavares', 'Affiliation': 'W. Tavares is assistant professor and scientist, The Wilson Centre, and Post-MD Education, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada; ORCID: https://orcid.org/0000-0001-8267-9448. M. Young is associate professor, Department of Medicine, McGill University, Montreal, Quebec, Canada; ORCID: https://orcid.org/0000-0002-2036-2119. G. Gauthier is adjunct professor, Medecine Interne, Université de Sherbrooke, Sherbrooke, Quebec, Canada; ORCID: https://orcid.org/0000-0001-7368-638X. C. St-Onge is professor, Department of Medicine, Faculty of Medicine and Health Sciences, Université de Sherbrooke, Sherbrooke, Quebec, Canada; ORCID: http://orcid.org/0000-0001-5313-0456.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Young', 'Affiliation': ''}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': 'Gauthier', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'St-Onge', 'Affiliation': ''}]",Academic medicine : journal of the Association of American Medical Colleges,['10.1097/ACM.0000000000003076']
1310,31033362,Reversal of an unfavorable effect of hydrochlorothiazide compared to angiotensin converting enzyme inhibitor on serum uric acid and oxypurine levels by estrogen-progestin therapy in hypertensive postmenopausal women.,"Background:  The aim was to assess the effect of estrogen-progestin therapy (EPT) on serum levels of uric acid (SUA) and its precursors xanthine (X) and hypoxanthine (HX), and on uric acid (UA) renal excretion in hypertensive postmenopausal women treated with an angiotensin-converting enzyme inhibitor (ACEI) or thiazide diuretic (HCTZ) (ClinicalTrials.gov identifier: NCT03921736, registered 19 April 2019).  Methods:  Postmenopausal women with untreated essential hypertension were recruited to the study. The control group consisted of 40 postmenopausal women with normal blood pressure. Hypertensive women were randomized to two groups: hydrochlorothiazide ( n  = 50) or perindopril ( n  = 50) and to a group receiving or not receiving EPT (EPT+/EPT-) due to vasomotor symptoms. The follow-up period was one year. Blood pressure measurements as well as blood tests for SUA and its precursors X and HX were performed at baseline and after 12 months.  Results:  In hypertensive women, baseline serum X and HX were significantly higher when compared to the group of normotensive women. Treatment with HCTZ led to a statistically significant increase in SUA in the subgroup of EPT- women. In this group concentrations of X and HX increased significantly after 12 months. UA/X significantly decreased after treatment with HCTZ. Lack of EPT resulted in a decrease of renal plasma flow in the HCTZ group. However, in the HCTZ and EPT + group, SUA decreased significantly when compared to baseline. None of these unfavorable effects was observed in the ACEI group regardless of EPT.  Conclusions:  1) EPT prevents the development of hyperuricemia during antihypertensive treatment with thiazide diuretics. 2) Arterial hypertension and menopause cause impairment of UA excretion and increase the levels of SUA and its precursors X and HX. 3) EPT reduces the risk of hyperuricemia in postmenopausal women.",2019,"In hypertensive women, baseline serum X and HX were significantly higher when compared to the group of normotensive women.","['hypertensive postmenopausal women', 'postmenopausal women', '40 postmenopausal women with normal blood pressure', 'hypertensive postmenopausal women treated with an', 'Postmenopausal women with untreated essential hypertension', 'Hypertensive women']","['estrogen-progestin therapy (EPT', 'thiazide diuretics', 'estrogen-progestin therapy', 'hydrochlorothiazide', 'angiotensin converting enzyme inhibitor', 'HCTZ', 'EPT', 'perindopril ( n \u2009=\u200950) and to a group receiving or not receiving EPT (EPT+/EPT', 'angiotensin-converting enzyme inhibitor (ACEI) or thiazide diuretic (HCTZ) ']","['X and HX', 'Blood pressure measurements', 'SUA', 'baseline serum X and HX', 'serum levels of uric acid (SUA) and its precursors xanthine (X) and hypoxanthine (HX), and on uric acid (UA) renal excretion', 'renal plasma flow', 'serum uric acid and oxypurine levels']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure (finding)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0085580', 'cui_str': 'Essential Hypertension'}]","[{'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C0279495', 'cui_str': 'Progestogen hormone therapy (procedure)'}, {'cui': 'C0039512', 'cui_str': 'Teniposide'}, {'cui': 'C0012802', 'cui_str': 'Benzothiadiazine Diuretics'}, {'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0136123', 'cui_str': 'Perindopril'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0005824', 'cui_str': 'Blood pressure taking (procedure)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C3541955', 'cui_str': 'Xanthines'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1373187', 'cui_str': 'Renal Excretion'}, {'cui': 'C0206087', 'cui_str': 'Renal Plasma Flow'}, {'cui': 'C0455272', 'cui_str': 'Serum uric acid measurement'}]",40.0,0.0318024,"In hypertensive women, baseline serum X and HX were significantly higher when compared to the group of normotensive women.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Posadzy-Malaczynska', 'Affiliation': 'Department of Family Medicine, Poznan University of Medical Sciences , Poznań , Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Rajpold', 'Affiliation': 'Heart Division, Royal Brompton & Harefield NHS Foundation Trust , London , UK.'}, {'ForeName': 'Lucyna', 'Initials': 'L', 'LastName': 'Woznicka-Leskiewicz', 'Affiliation': 'Department of Family Medicine, Poznan University of Medical Sciences , Poznań , Poland.'}, {'ForeName': 'Justyna', 'Initials': 'J', 'LastName': 'Marcinkowska', 'Affiliation': 'Department of Computer Science and Statistics, Poznan University of Medical Sciences , Poznań , Poland.'}]",Current medical research and opinion,['10.1080/03007995.2019.1612656']
1311,30900158,"PF-06881893 (Nivestym™), a Filgrastim Biosimilar, Versus US-Licensed Filgrastim Reference Product (US-Neupogen ® ): Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Safety of Single or Multiple Subcutaneous Doses in Healthy Volunteers.","BACKGROUND


Three comparative clinical studies assessed the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity and safety of PF-06881893 (filgrastim-aafi; Nivestym™), a filgrastim biosimilar, versus US-licensed reference product (filgrastim; US-Neupogen ® ) in healthy volunteers (HVs).
METHODS


Two separate open-label, crossover-design PK/PD studies were conducted: a single-dose study (n = 24) and a multiple-dose study (n = 60). In each study, HVs were randomized to Nivestym followed by US-Neupogen, or vice versa. Study drug (5 μg/kg) was administered subcutaneously as a single injection or as five consecutive daily injections. Primary PK and PD endpoints were area under the filgrastim serum concentration-time curve, maximum observed concentration, area under the effect curve (AUEC) for absolute neutrophil count (ANC), maximum observed ANC, AUEC for cluster of differentiation (CD)-34 +  count, and maximum observed CD34 +  count. In an open-label, parallel-design, non-inferiority, comparative immunogenicity study, HVs were randomized (n = 128/treatment) to Nivestym or US-Neupogen. The primary endpoint was the proportion of subjects with a negative baseline antidrug antibody (ADA) test result and one or more confirmed post-dose positive ADA result.
RESULTS


Overall demographics were as follows: female (n = 162/340); White (n = 274/340), Black (n = 58/340), and other (n = 8/340); age (18-65 years); and weight (50.8-96.5 kg). All primary PK and PD endpoints met the pre-specified criteria for PK and PD equivalence. The primary endpoint in the comparative immunogenicity study met pre-specified criteria for non-inferiority.
CONCLUSIONS


Nivestym demonstrated PK and PD equivalence in single and multiple subcutaneous-dose settings and non-inferiority for immunogenicity to US-Neupogen, with a comparable safety profile, supporting the demonstration of biosimilarity.
TRIAL REGISTRATION


ClinicalTrials.gov C1121002 (NCT02766647); C1121003 (NCT02766634); C1121012 (NCT02923791).",2019,"The primary endpoint in the comparative immunogenicity study met pre-specified criteria for non-inferiority.
CONCLUSIONS


Nivestym demonstrated PK and PD equivalence in single and multiple subcutaneous-dose settings and non-inferiority for immunogenicity to US-Neupogen, with a comparable safety profile, supporting the demonstration of biosimilarity.
","['healthy volunteers (HVs', 'Healthy Volunteers', 'White (n\u2009=\u2009274/340), Black (n\u2009=\u200958/340), and other (n\u2009=\u20098/340); age (18-65\xa0years); and weight (50.8-96.5\xa0kg']",['Nivestym or US-Neupogen'],"['comparative immunogenicity study met pre-specified criteria for non-inferiority.\nCONCLUSIONS\n\n\nNivestym demonstrated PK and PD equivalence in single and multiple subcutaneous-dose settings and non-inferiority for immunogenicity to US-Neupogen', 'proportion of subjects with a negative baseline antidrug antibody (ADA) test result and one or more confirmed post-dose positive ADA result', 'pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity and safety', 'filgrastim serum concentration-time curve, maximum observed concentration, area under the effect curve (AUEC) for absolute neutrophil count (ANC), maximum observed ANC, AUEC for cluster of differentiation (CD)-34 +  count, and maximum observed CD34 +  count']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4517907', 'cui_str': 'Ninety-six point five'}]","[{'cui': 'C0733468', 'cui_str': 'Neupogen'}]","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0733468', 'cui_str': 'Neupogen'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0580327', 'cui_str': 'Antibody studies (procedure)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0439568', 'cui_str': 'Post-dose (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}]",,0.06583,"The primary endpoint in the comparative immunogenicity study met pre-specified criteria for non-inferiority.
CONCLUSIONS


Nivestym demonstrated PK and PD equivalence in single and multiple subcutaneous-dose settings and non-inferiority for immunogenicity to US-Neupogen, with a comparable safety profile, supporting the demonstration of biosimilarity.
","[{'ForeName': 'Hsuan-Ming', 'Initials': 'HM', 'LastName': 'Yao', 'Affiliation': 'Pfizer Inc, 275 N Field Dr. Bldg H1-3S, Lake Forest, IL, 60045, USA. hsuan-ming.yao@pfizer.com.'}, {'ForeName': 'Faith D', 'Initials': 'FD', 'LastName': 'Ottery', 'Affiliation': 'Pfizer Inc, 275 N Field Dr. Bldg H1-3S, Lake Forest, IL, 60045, USA.'}, {'ForeName': 'Troy', 'Initials': 'T', 'LastName': 'Borema', 'Affiliation': 'Quotient Sciences, Miami, FL, USA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Harris', 'Affiliation': 'Quotient Sciences, Miami, FL, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Levy', 'Affiliation': 'Quotient Sciences, Miami, FL, USA.'}, {'ForeName': 'Tom B', 'Initials': 'TB', 'LastName': 'May', 'Affiliation': 'Pfizer Inc, 275 N Field Dr. Bldg H1-3S, Lake Forest, IL, 60045, USA.'}, {'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Moosavi', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Pfizer Inc, 275 N Field Dr. Bldg H1-3S, Lake Forest, IL, 60045, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Summers', 'Affiliation': 'Pfizer Inc, San Diego, CA, USA.'}]","BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy",['10.1007/s40259-019-00343-8']
1312,31719190,Usefulness of Oscillations Added to Mechanical In-Exsufflation in Amyotrophic Lateral Sclerosis.,"BACKGROUND


Assisted coughing via mechanical in-exsufflation (MI-E) is a first-line treatment for secretion management in patients with amyotrophic lateral sclerosis (ALS) with unassisted CPF < 4.25 L/s. Some devices enable oscillations to be added to MI-E (MI-E+O). We sought to determine whether adding oscillations to MI-E enables a reduction in the use of invasive secretion management procedures (ie, bronchoscopy or tracheostomy) in subjects with ALS.
METHODS


We conducted a 12-month, prospective, randomized follow-up study of subjects with ALS for whom assisted coughing techniques were indicated. One group was treated with oscillations in addition to MI-E (MI-E+O), and the other group was treated with conventional MI-E.
RESULTS


29 subjects were included in the MI-E group and 27 subjects were included in the MI-E+O group. Five subjects (8.9%) required invasive techniques for secretion management (3 in the MI-E group and 2 in the MI-E+O group,  P  = .70). Treatment with MI-E+O did not alter the risk of invasive procedures (odds ratio 0.69, 95% CI 0.10-4.50,  P  = .70). The mean number of respiratory infections was 0.58 ± 0.16 in the MI-E group and 0.025 ± 0.08 in the MI-E+O group ( P  = .10). Survival was 8.96 ± 0.18 months in the MI-E group and 7.70 ± 0.70 months in the MI-E+O group ( P  = .10).
CONCLUSION


Adding oscillations to MI-E did not enable a reduction in the need to perform invasive procedures for secretion management in subjects with ALS.",2020,"Treatment with MI-E+O did not alter the risk of invasive procedures (odds ratio 0.69, 95% CI 0.10-4.50,  P  = .70).","['subjects with ALS', 'Amyotrophic Lateral Sclerosis', 'subjects with ALS for whom assisted coughing techniques', '29 subjects were included in the MI-E group and 27 subjects were included in the MI-E+O group', 'patients with amyotrophic lateral sclerosis (ALS) with unassisted CPF < 4.25 L/s']","['invasive secretion management procedures (ie, bronchoscopy or tracheostomy']","['risk of invasive procedures', 'invasive techniques for secretion management', 'mean number of respiratory infections', 'Survival']","[{'cui': 'C0002736', 'cui_str': 'ALS (Amyotrophic Lateral Sclerosis)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439394', 'cui_str': 'L/s'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0348025', 'cui_str': 'Open approach - access (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",29.0,0.0266746,"Treatment with MI-E+O did not alter the risk of invasive procedures (odds ratio 0.69, 95% CI 0.10-4.50,  P  = .70).","[{'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Sancho', 'Affiliation': 'Respiratory Care Unit, Respiratory Medicine Department, Hospital Clinico Universitario, Valencia, Spain. jesus.sancho@uv.es.'}, {'ForeName': 'Enric', 'Initials': 'E', 'LastName': 'Burés', 'Affiliation': 'Respiratory Care Unit, Respiratory Medicine Department, Hospital Clinico Universitario, Valencia, Spain.'}, {'ForeName': 'Santos', 'Initials': 'S', 'LastName': 'Ferrer', 'Affiliation': 'Respiratory Care Unit, Respiratory Medicine Department, Hospital Clinico Universitario, Valencia, Spain.'}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Bondía', 'Affiliation': 'Respiratory Care Unit, Respiratory Medicine Department, Hospital Clinico Universitario, Valencia, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Servera', 'Affiliation': 'Respiratory Care Unit, Respiratory Medicine Department, Hospital Clinico Universitario, Valencia, Spain.'}]",Respiratory care,['10.4187/respcare.07202']
1313,30987504,Estimation of overdiagnosis by detection to incidence ratio in cancer screening.,,2019,"As an example to evaluate this, we used screening for colorectal cancer, run as a randomized public health policy in Finland.
",[],[],[],[],[],[],,0.0654578,"As an example to evaluate this, we used screening for colorectal cancer, run as a randomized public health policy in Finland.
","[{'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Hakama', 'Affiliation': 'Finnish Cancer Registry, Helsinki, Finland.'}, {'ForeName': 'Nea', 'Initials': 'N', 'LastName': 'Malila', 'Affiliation': 'Finnish Cancer Registry, Helsinki, Finland.'}]",Journal of medical screening,['10.1177/0969141319842910']
1314,31370912,"Trajectories and Predictors of Children's Early-Starting Conduct Problems: Child, Family, Genetic, and Intervention Effects.","Several research teams have previously traced patterns of emerging conduct problems (CP) from early or middle childhood. The current study expands on this previous literature by using a genetically-informed, experimental, and long-term longitudinal design to examine trajectories of early-emerging conduct problems and early childhood discriminators of such patterns from the toddler period to adolescence. The sample represents a cohort of 731 toddlers and diverse families recruited based on socioeconomic, child, and family risk, varying in urbanicity and assessed on nine occasions between ages 2 and 14. In addition to examining child, family, and community level discriminators of patterns of emerging conduct problems, we were able to account for genetic susceptibility using polygenic scores and the study's experimental design to determine whether random assignment to the Family Check-Up (FCU) discriminated trajectory groups. In addition, in accord with differential susceptibility theory, we tested whether the effects of the FCU were stronger for those children with higher genetic susceptibility. Results augmented previous findings documenting the influence of child (inhibitory control [IC], gender) and family (harsh parenting, parental depression, and educational attainment) risk. In addition, children in the FCU were overrepresented in the persistent low versus persistent high CP group, but such direct effects were qualified by an interaction between the intervention and genetic susceptibility that was consistent with differential susceptibility. Implications are discussed for early identification and specifically, prevention efforts addressing early child and family risk.",2019,"In addition, children in the FCU were overrepresented in the persistent low versus persistent high CP group, but such direct effects were qualified by an interaction between the intervention and genetic susceptibility that was consistent with differential susceptibility.","['731 toddlers and diverse families recruited based on socioeconomic, child, and family risk, varying in urbanicity and assessed on nine occasions between ages 2 and 14']",[],"['child (inhibitory control [IC], gender) and family (harsh parenting, parental depression, and educational attainment) risk']","[{'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",731.0,0.0284405,"In addition, children in the FCU were overrepresented in the persistent low versus persistent high CP group, but such direct effects were qualified by an interaction between the intervention and genetic susceptibility that was consistent with differential susceptibility.","[{'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Shaw', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Chardée A', 'Initials': 'CA', 'LastName': 'Galán', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Lemery-Chalfant', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Dishion', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Kit K', 'Initials': 'KK', 'LastName': 'Elam', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Melvin N', 'Initials': 'MN', 'LastName': 'Wilson', 'Affiliation': 'Department of Psychology, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Gardner', 'Affiliation': 'Department of Social Policy & Intervention, University of Oxford, Oxford, UK.'}]",Development and psychopathology,['10.1017/S0954579419000828']
1315,31002449,"The relationships between worry, happiness and pain catastrophizing in the experience of acute pain.","BACKGROUND


The current study aimed to (a) evaluate the effects of an experimental manipulation of worry and happiness on pain perception and measures of worry about pain and pain catastrophizing and (b) determine if changes in situation-specific worry about pain and pain catastrophizing would be related to changes in acute pain.
METHODS


The study included 120 healthy, pain-free volunteers. Participants were exposed to four levels of noxious stimulation and asked to report on the pain intensity, worry about pain and pain catastrophizing they experienced during the stimulation procedures. They were then randomly assigned to either a Happy or a Worry condition, where they were exposed to emotion induction procedures. The noxious exposure procedures and measures of pain, pain-related worry and pain catastrophizing were then repeated.
RESULTS


Participants in the Worry condition reported significant increases in pain intensity, and those in the Happy condition reported significant decreases in pain intensity. Further, the Worry condition participants reported significant increases in both pain-related worry and pain catastrophizing, while the Happy condition showed the opposite effects. Finally, changes in worry about pain and pain catastrophizing were found to mediate the impact of the affect induction procedure on pain intensity.
CONCLUSIONS


The findings demonstrate that pain intensity, worry about pain and pain catastrophizing are all sensitive to changes in mood. The results have potential clinical implications.
SIGNIFICANCE


The current study shows that manipulation-induced changes in pain-related worry, pain catastrophizing, and affect have direct effects on the experience of acute pain. More broadly, the overlap of these three variables provides with anxiety and mood disorders offers the promise of new vistas for research and treatment of pain conditions by assessing and targeting the cognitions and behaviors that are common to worry and catastrophizing.",2019,"Finally, changes in worry about pain and pain catastrophizing were found to mediate the impact of the affect induction procedure on pain intensity.
","['120 healthy, pain-free volunteers']",['Happy or a Worry condition'],"['pain intensity, worry about pain and pain catastrophizing', 'pain, pain-related worry and pain catastrophizing', 'pain-related worry and pain catastrophizing', 'pain-related worry, pain catastrophizing', 'pain intensity']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",120.0,0.0321842,"Finally, changes in worry about pain and pain catastrophizing were found to mediate the impact of the affect induction procedure on pain intensity.
","[{'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Lefebvre', 'Affiliation': 'Department of Psychology, Wofford College, Spartanburg, South Carolina.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Jensen', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington, Seattle, Washington.'}]","European journal of pain (London, England)",['10.1002/ejp.1405']
1316,30577900,Lessons learned from measuring fidelity with the Motivational Interviewing Treatment Integrity code (MITI 4).,"BACKGROUND AND AIMS


The Motivational Interviewing Treatment Integrity code (MITI) measures fidelity to, and the quality of, Motivational Interviewing (MI), and can also be used when MI is combined with other treatment methods. The current study presents a fidelity measurement with the MITI 4.2.1, in both Motivational Enhancement Therapy sessions and the combined Community Reinforcement Approach-Senior (CRAS).
METHOD


The MITI 4.2.1 was used to evaluate treatment sessions provided in the Elderly Study, a multi-national randomized trial evaluating treatment for alcohol use disorders in the elderly. Following expert recommendations, training was conducted at two international sites as well as at the Danish site. Twenty percent of the sessions at the Danish study site were rated. Twelve percent were multiply rated by all raters. Interrater reliability was assessed by the Intraclass Correlations Coefficient (ICC).
RESULTS


Mean ICC of the 52 sessions rated by all raters was 0.78 (95% CI: 0.70; 0.86). The rare measures confront and emphasize autonomy, and the global measure softening sustain talk only reached fair levels of ICC, while the remaining measures were good or excellent. In the sessions of MI combined with other treatment approaches in the CRAS, the MITI 4.2.1 has a similar reliability as in MET sessions only, except for the measure persuade with permission.
CONCLUSION


The MITI 4.2.1 is a reliable instrument for measuring fidelity to Motivational Interviewing elements, also in the context of Community Reinforcement Approach Senior. However, in softening sustain talk, the rare measures, and persuade with permission it has proved more difficult to reach high levels of interrater reliability.",2019,Mean ICC of the 52 sessions rated by all raters was 0.78,['alcohol use disorders in the elderly'],[],"['Interrater reliability', 'Mean ICC', 'quality of, Motivational Interviewing (MI']","[{'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",[],"[{'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}]",,0.0155036,Mean ICC of the 52 sessions rated by all raters was 0.78,"[{'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'Kramer Schmidt', 'Affiliation': 'Unit of Clinical Alcohol Research, University of Southern Denmark, J.B. Winsløwsvej 20, entrance 220B, 5000 Odense C, Denmark. Electronic address: lkramer@health.sdu.dk.'}, {'ForeName': 'Kjeld', 'Initials': 'K', 'LastName': 'Andersen', 'Affiliation': 'Unit of Clinical Alcohol Research, University of Southern Denmark, J.B. Winsløwsvej 20, entrance 220B, 5000 Odense C, Denmark; Department of Mental Health, Region of Southern Denmark, Denmark. Electronic address: Kjeld.andersen@rsyd.dk.'}, {'ForeName': 'Anette Søgaard', 'Initials': 'AS', 'LastName': 'Nielsen', 'Affiliation': 'Unit of Clinical Alcohol Research, University of Southern Denmark, J.B. Winsløwsvej 20, entrance 220B, 5000 Odense C, Denmark; OPEN Odense Patient data Explorative Network, Denmark. Electronic address: ansnielsen@health.sdu.dk.'}, {'ForeName': 'Theresa B', 'Initials': 'TB', 'LastName': 'Moyers', 'Affiliation': 'Center on Alcoholism, Substance Abuse, and Addictions, MSC11 6280, 1 University of New Mexico, Albuquerque, NM 87131, United States. Electronic address: tmoyers@unm.edu.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2018.11.004']
1317,30577903,Randomized effectiveness trial of a parent and youth combined intervention on the substance use norms of Latino middle school students.,"This article advances knowledge about the effectiveness of applying a community-based efficacious parenting intervention in parallel with an efficacious preadolescent intervention in changing substance abuse norms among preadolescent Latino youth. The study employed a longitudinal, randomized control group design comparing three groups: (1) Parent intervention combined with a Youth intervention: Parent/Youth; (2) Parent intervention without a Youth intervention: Parent Only; and (3) Treatment as usual: Comparison. In the comparison group, parents participated in a standard parenting program delivered by the community partner, and the youth received the usual drug use prevention programming offered in their schools. Data from both parents and youth at the19 participating schools were collected at pre-test, immediate post-test (4 months after pre-test), and two follow-up (8 & 20 months after the pre-test). The total sample includes 532 families (parent-child dyads). The parent-child dyads consisted of one parent and one youth ages 12-14. The retention rates for both parents and preadolescent were high across the different waves of data collection (79%-96%). Regression results of youth substance use norms were calculated based on three permutations of data: (a) original data, with no imputation and no propensity score matching; (b) imputed data but no propensity score matching; and (c) imputed data plus propensity score matching. Compared to the Comparison group, the Parent/Youth condition was the most effective in changing youth's norms, closely followed by the Parent Only condition. These findings make a significant contribution in advancing knowledge on family/youth substance use prevention for Latinos in a community environment. Although the study took place in a specific urban center in the Southwest US, its findings can be generalized to other urban communities of similar characteristics across the country.",2019,"Compared to the Comparison group, the Parent/Youth condition was the most effective in changing youth's norms, closely followed by the Parent Only condition.","['preadolescent Latino youth', 'Latino middle school students', '532 families (parent-child dyads', 'Parent/Youth']","['intervention combined with a Youth intervention', '2) Parent intervention without a Youth intervention', 'parent and youth combined intervention', 'community-based efficacious parenting intervention', 'standard parenting program delivered by the community partner, and the youth received the usual drug use prevention programming offered in their schools']",['retention rates'],"[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}]",,0.02619,"Compared to the Comparison group, the Parent/Youth condition was the most effective in changing youth's norms, closely followed by the Parent Only condition.","[{'ForeName': 'Flavio F', 'Initials': 'FF', 'LastName': 'Marsiglia', 'Affiliation': 'Southwest Interdisciplinary Research Center, School of Social Work, Arizona State University, United States of America.'}, {'ForeName': 'Shiyou', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Southwest Interdisciplinary Research Center, School of Social Work, Arizona State University, United States of America.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Ayers', 'Affiliation': 'Southwest Interdisciplinary Research Center, School of Social Work, Arizona State University, United States of America. Electronic address: Stephanie.L.Ayers@asu.edu.'}, {'ForeName': 'Arianna', 'Initials': 'A', 'LastName': 'Weide', 'Affiliation': 'Southwest Interdisciplinary Research Center, School of Social Work, Arizona State University, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2018.11.012']
1318,30975627,"Erlotinib plus bevacizumab versus erlotinib alone in patients with EGFR-positive advanced non-squamous non-small-cell lung cancer (NEJ026): interim analysis of an open-label, randomised, multicentre, phase 3 trial.","BACKGROUND


Resistance to first-generation or second-generation EGFR tyrosine kinase inhibitor (TKI) monotherapy develops in almost half of patients with EGFR-positive non-small-cell lung cancer (NSCLC) after 1 year of treatment. The JO25567 phase 2 trial comparing erlotinib plus bevacizumab combination therapy with erlotinib monotherapy established the activity and manageable toxicity of erlotinib plus bevacizumab in patients with NSCLC. We did a phase 3 trial to validate the results of the JO25567 study and report here the results from the preplanned interim analysis.
METHODS


In this prespecified interim analysis of the randomised, open-label, phase 3 NEJ026 trial, we recruited patients with stage IIIB-IV disease or recurrent, cytologically or histologically confirmed non-squamous NSCLC with activating EGFR genomic aberrations from 69 centres across Japan. Eligible patients were at least 20 years old, and had an Eastern Cooperative Oncology Group performance status of 2 or lower, no previous chemotherapy for advanced disease, and one or more measurable lesions based on Response Evaluation Criteria in Solid Tumours (1.1). Patients were randomly assigned (1:1) to receive oral erlotinib 150 mg per day plus intravenous bevacizumab 15 mg/kg once every 21 days, or erlotinib 150 mg per day monotherapy. Randomisation was done by minimisation, stratified by sex, smoking status, clinical stage, and EGFR mutation subtype. The primary endpoint was progression-free survival. This study is ongoing; the data cutoff for this prespecified interim analysis was Sept 21, 2017. Efficacy was analysed in the modified intention-to-treat population, which included all randomly assigned patients who received at least one dose of treatment and had at least one response evaluation. Safety was analysed in all patients who received at least one dose of study drug. The trial is registered with the University Hospital Medical Information Network Clinical Trials Registry, number UMIN000017069.
FINDINGS


Between June 3, 2015, and Aug 31, 2016, 228 patients were randomly assigned to receive erlotinib plus bevacizumab (n=114) or erlotinib alone (n=114). 112 patients in each group were evaluable for efficacy, and safety was evaluated in 112 patients in the combination therapy group and 114 in the monotherapy group. Median follow-up was 12·4 months (IQR 7·0-15·7). At the time of interim analysis, median progression-free survival for patients in the erlotinib plus bevacizumab group was 16·9 months (95% CI 14·2-21·0) compared with 13·3 months (11·1-15·3) for patients in the erlotinib group (hazard ratio 0·605, 95% CI 0·417-0·877; p=0·016). 98 (88%) of 112 patients in the erlotinib plus bevacizumab group and 53 (46%) of 114 patients in the erlotinib alone group had grade 3 or worse adverse events. The most common grade 3-4 adverse event was rash (23 [21%] of 112 patients in the erlotinib plus bevacizumab group vs 24 [21%] of 114 patients in the erlotinib alone group). Nine (8%) of 112 patients in the erlotinib plus bevacizumab group and five (4%) of 114 patients in the erlotinib alone group had serious adverse events. The most common serious adverse events were grade 4 neutropenia (two [2%] of 112 patients in the erlotinib plus bevacizumab group) and grade 4 hepatic dysfunction (one [1%] of 112 patients in the erlotinib plus bevacizumab group and one [1%] of 114 patients in the erlotinib alone group). No treatment-related deaths occurred.
INTERPRETATION


The results of this interim analysis showed that bevacizumab plus erlotinib combination therapy improves progression-free survival compared with erlotinib alone in patients with EGFR-positive NSCLC. Future studies with longer follow-up, and overall survival and quality-of-life data will be required to further assess the efficacy of this combination in this setting.
FUNDING


Chugai Pharmaceutical.",2019,The most common grade 3-4 adverse event was rash (23 [21%] of 112 patients in the erlotinib plus bevacizumab group vs 24 [21%] of 114 patients in the erlotinib alone group).,"['patients with stage IIIB-IV disease or recurrent, cytologically or histologically confirmed non-squamous NSCLC with activating EGFR genomic aberrations from 69 centres across Japan', 'patients with EGFR-positive NSCLC', '112 patients in the combination therapy group and 114 in the monotherapy group', 'patients with NSCLC', 'patients with EGFR-positive advanced non-squamous non-small-cell lung cancer (NEJ026', 'Eligible patients were at least 20 years old, and had an Eastern Cooperative Oncology Group performance status of 2 or lower, no previous chemotherapy for advanced disease, and one or more measurable lesions based on Response Evaluation Criteria in Solid Tumours (1.1', 'Between June 3, 2015, and Aug 31, 2016, 228 patients']","['bevacizumab', 'Erlotinib plus bevacizumab', 'erlotinib alone', 'oral erlotinib 150 mg per day plus intravenous bevacizumab', 'erlotinib 150 mg per day monotherapy', 'erlotinib plus bevacizumab', 'bevacizumab plus erlotinib combination therapy']","['Efficacy', 'grade 3 or worse adverse events', 'median progression-free survival', 'serious adverse events', 'progression-free survival', 'grade 4 hepatic dysfunction', 'activity and manageable toxicity', 'efficacy, and safety', 'Safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0887950', 'cui_str': 'Genomics'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0303405', 'cui_str': '114In radioisotope'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C4324656', 'cui_str': 'Non-squamous non-small cell lung cancer'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C4517491', 'cui_str': 'One point one'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2978152', 'cui_str': 'erlotinib 150 MG [Tarceva]'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0086565', 'cui_str': 'Liver Dysfunction'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",228.0,0.181871,The most common grade 3-4 adverse event was rash (23 [21%] of 112 patients in the erlotinib plus bevacizumab group vs 24 [21%] of 114 patients in the erlotinib alone group).,"[{'ForeName': 'Haruhiro', 'Initials': 'H', 'LastName': 'Saito', 'Affiliation': 'Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Tatsuro', 'Initials': 'T', 'LastName': 'Fukuhara', 'Affiliation': 'Miyagi Cancer Center, Natori, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Furuya', 'Affiliation': 'St Marianna University School of Medicine, Kawasaki, Japan.'}, {'ForeName': 'Kana', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Miyagi Cancer Center, Natori, Japan.'}, {'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Sugawara', 'Affiliation': 'Sendai Kousei Hospital, Sendai, Japan.'}, {'ForeName': 'Shunichiro', 'Initials': 'S', 'LastName': 'Iwasawa', 'Affiliation': 'Chiba University, Chiba, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Tsunezuka', 'Affiliation': 'Ishikawa Prefectural Central Hospital, Kanazawa, Japan.'}, {'ForeName': 'Ou', 'Initials': 'O', 'LastName': 'Yamaguchi', 'Affiliation': 'Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Morihito', 'Initials': 'M', 'LastName': 'Okada', 'Affiliation': 'Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Kozo', 'Initials': 'K', 'LastName': 'Yoshimori', 'Affiliation': 'Fukujuji Hospital, Tokyo, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Nakachi', 'Affiliation': 'Saiseikai Utsunomiya Hospital, Utsunomiya, Japan.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Gemma', 'Affiliation': 'Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Azuma', 'Affiliation': 'Kurume University, Kurume, Japan.'}, {'ForeName': 'Futoshi', 'Initials': 'F', 'LastName': 'Kurimoto', 'Affiliation': 'Saitama Cancer Center, Saitama, Japan.'}, {'ForeName': 'Yukari', 'Initials': 'Y', 'LastName': 'Tsubata', 'Affiliation': 'Shimane University, Shimane, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Fujita', 'Affiliation': 'National Hospital Organization Asahikawa Medical Center, Asahikawa, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Nagashima', 'Affiliation': 'Iwate Medical University School of Medicine, Morioka, Japan.'}, {'ForeName': 'Gyo', 'Initials': 'G', 'LastName': 'Asai', 'Affiliation': 'Aichi Cancer Center Aichi Hospital, Okazaki, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Watanabe', 'Affiliation': 'Niigata University Medical and Dental Hospital, Niigata, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Miyazaki', 'Affiliation': 'Suita Municipal Hospital, Osaka, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Hagiwara', 'Affiliation': 'Jichi Medical University, Shimotsuke, Japan.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Nukiwa', 'Affiliation': 'Tohoku University, Miyagi, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Kunihiko', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Maemondo', 'Affiliation': 'Iwate Medical University School of Medicine, Morioka, Japan. Electronic address: maemondo-ma693@aioros.ocn.ne.jp.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30035-X']
1319,29705519,The role of IL-1 in postprandial fatigue.,"OBJECTIVES


Cytokines such as IL-1 seems to play a role in the pathogenesis of fatigue associated with some chronic diseases and anti-inflammatory treatment has been shown to reduce these symptoms. Ingestion of a calorie rich meal leads to postprandial fatigue, and is associated with increased systemic concentrations of cytokines, which is more pronounced in obese than lean subjects. We investigated whether postprandial fatigue is regulated by IL-1, and therefore reduced by IL-1 antagonism, in lean and obese subjects.
METHODS


In a double-blind, crossover study in 8 lean and 8 obese male subjects, randomized to receive either saline (placebo) or the IL-1 receptor antagonist anakinra, we investigated whether postprandial fatigue was regulated by IL-1. To promote postprandial fatigue, subjects ran 30 min prior to a high-fat, high-carbohydrate meal. Fatigue was determined using the Stanford Sleepiness Scale and blood samples were drawn at baseline and after the intervention.
RESULTS


IL-1 antagonism led to a reduction in postprandial fatigue and this effect was more pronounced in obese than lean individuals.
CONCLUSIONS


We conclude that IL-1 is involved in the regulation of postprandial fatigue under physiologic conditions in lean and obese individuals. It remains to be shown whether this effect translates into clinical relevant effects.",2018,"RESULTS


IL-1 antagonism led to a reduction in postprandial fatigue and this effect was more pronounced in obese than lean individuals.
","['obese than lean subjects', '8 lean and 8 obese male subjects', 'lean and obese subjects', 'lean and obese individuals']","['saline (placebo', 'calorie rich meal', 'IL-1']","['Fatigue', 'postprandial fatigue', 'Stanford Sleepiness Scale and blood samples']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0021755', 'cui_str': 'T Helper Factor'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0222045'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",8.0,0.0863659,"RESULTS


IL-1 antagonism led to a reduction in postprandial fatigue and this effect was more pronounced in obese than lean individuals.
","[{'ForeName': 'Louise L', 'Initials': 'LL', 'LastName': 'Lehrskov', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, Rigshospitalet 7641, Blegdamsvej 9, DK 2100, Copenhagen, Denmark. Electronic address: louise@lehrskov.dk.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Dorph', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, Rigshospitalet 7641, Blegdamsvej 9, DK 2100, Copenhagen, Denmark.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Widmer', 'Affiliation': 'Clinic of Endocrinology, Diabetes & Metabolism and Department Biomedicine, University Hospital Basel, Spitalstrasse 21, 4031, Basel, Switzerland.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Hepprich', 'Affiliation': 'Clinic of Endocrinology, Diabetes & Metabolism and Department Biomedicine, University Hospital Basel, Spitalstrasse 21, 4031, Basel, Switzerland.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Siegenthaler', 'Affiliation': 'Clinic of Endocrinology, Diabetes & Metabolism and Department Biomedicine, University Hospital Basel, Spitalstrasse 21, 4031, Basel, Switzerland.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Timper', 'Affiliation': 'Clinic of Endocrinology, Diabetes & Metabolism and Department Biomedicine, University Hospital Basel, Spitalstrasse 21, 4031, Basel, Switzerland.'}, {'ForeName': 'Marc Y', 'Initials': 'MY', 'LastName': 'Donath', 'Affiliation': 'Clinic of Endocrinology, Diabetes & Metabolism and Department Biomedicine, University Hospital Basel, Spitalstrasse 21, 4031, Basel, Switzerland.'}]",Molecular metabolism,['10.1016/j.molmet.2018.04.001']
1320,29706321,Resveratrol improves ex vivo mitochondrial function but does not affect insulin sensitivity or brown adipose tissue in first degree relatives of patients with type 2 diabetes.,"OBJECTIVE


Resveratrol supplementation improves metabolic health in healthy obese men, but not in patients with type 2 diabetes (T2D) when given as add-on therapy. Therefore, we examined whether resveratrol can enhance metabolic health in men at risk of developing T2D. Additionally, we examined if resveratrol can stimulate brown adipose tissue (BAT).
METHODS


Thirteen male first degree relatives (FDR) of patients with T2D received resveratrol (150 mg/day) and placebo for 30 days in a randomized, placebo controlled, cross-over trial.
RESULTS


Resveratrol significantly improved ex vivo muscle mitochondrial function on a fatty acid-derived substrate. However, resveratrol did not improve insulin sensitivity, expressed as the rate of glucose disposal during a two-step hyperinsulinemic-euglycemic clamp. Also, intrahepatic and intramyocellular lipid content, substrate utilization, energy metabolism, and cold-stimulated  18 F-FDG glucose uptake in BAT (n = 8) remained unaffected by resveratrol. In vitro experiments in adipocytes derived from human BAT confirmed the lack of effect on BAT.
CONCLUSIONS


Resveratrol stimulates muscle mitochondrial function in FDR males, which is in concordance with previous results. However, no other metabolic benefits of resveratrol were found in this group. This could be attributed to subject characteristics causing alterations in metabolism of resveratrol and thereby affecting resveratrol's effectiveness. CLINICALTRIALS.
GOV ID


NCT02129595.",2018,"However, resveratrol did not improve insulin sensitivity, expressed as the rate of glucose disposal during a two-step hyperinsulinemic-euglycemic clamp.","['Thirteen male first degree relatives (FDR) of patients with T2D received resveratrol (150\xa0mg/day) and', 'patients with type 2 diabetes (T2D', 'healthy obese men', 'men at risk of developing T2D', 'FDR males']","['Resveratrol supplementation', 'placebo']","['insulin sensitivity', 'rate of glucose disposal', 'intrahepatic and intramyocellular lipid content, substrate utilization, energy metabolism, and cold-stimulated  18 F-FDG glucose uptake in BAT', 'metabolic health', 'ex\xa0vivo muscle mitochondrial function']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444502', 'cui_str': 'First degree (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2930481', 'cui_str': 'cis-Resveratrol'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C2930481', 'cui_str': 'cis-Resveratrol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0302995', 'cui_str': '18F radioisotope'}, {'cui': 'C0008139', 'cui_str': 'Bats'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0031843', 'cui_str': 'function'}]",13.0,0.103827,"However, resveratrol did not improve insulin sensitivity, expressed as the rate of glucose disposal during a two-step hyperinsulinemic-euglycemic clamp.","[{'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'de Ligt', 'Affiliation': 'Department of Nutrition and Movement Sciences, Maastricht Medical Centre, NUTRIM School of Nutrition and Translational Research in Metabolism, The Netherlands.'}, {'ForeName': 'Yvonne M H', 'Initials': 'YMH', 'LastName': 'Bruls', 'Affiliation': 'Department of Nutrition and Movement Sciences, Maastricht Medical Centre, NUTRIM School of Nutrition and Translational Research in Metabolism, The Netherlands; Department of Radiology, Maastricht University Medical Centre, NUTRIM School for Nutrition and Translational Research in Metabolism, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hansen', 'Affiliation': 'Department of Nutrition and Movement Sciences, Maastricht Medical Centre, NUTRIM School of Nutrition and Translational Research in Metabolism, The Netherlands.'}, {'ForeName': 'Marie-Fleur', 'Initials': 'MF', 'LastName': 'Habets', 'Affiliation': 'Department of Nutrition and Movement Sciences, Maastricht Medical Centre, NUTRIM School of Nutrition and Translational Research in Metabolism, The Netherlands.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'Havekes', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, Maastricht University Medical Centre, The Netherlands.'}, {'ForeName': 'Emmani B M', 'Initials': 'EBM', 'LastName': 'Nascimento', 'Affiliation': 'Department of Nutrition and Movement Sciences, Maastricht Medical Centre, NUTRIM School of Nutrition and Translational Research in Metabolism, The Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Moonen-Kornips', 'Affiliation': 'Department of Nutrition and Movement Sciences, Maastricht Medical Centre, NUTRIM School of Nutrition and Translational Research in Metabolism, The Netherlands.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Schaart', 'Affiliation': 'Department of Nutrition and Movement Sciences, Maastricht Medical Centre, NUTRIM School of Nutrition and Translational Research in Metabolism, The Netherlands.'}, {'ForeName': 'Vera B', 'Initials': 'VB', 'LastName': 'Schrauwen-Hinderling', 'Affiliation': 'Department of Nutrition and Movement Sciences, Maastricht Medical Centre, NUTRIM School of Nutrition and Translational Research in Metabolism, The Netherlands; Department of Radiology, Maastricht University Medical Centre, NUTRIM School for Nutrition and Translational Research in Metabolism, The Netherlands.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'van Marken Lichtenbelt', 'Affiliation': 'Department of Nutrition and Movement Sciences, Maastricht Medical Centre, NUTRIM School of Nutrition and Translational Research in Metabolism, The Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schrauwen', 'Affiliation': 'Department of Nutrition and Movement Sciences, Maastricht Medical Centre, NUTRIM School of Nutrition and Translational Research in Metabolism, The Netherlands. Electronic address: p.schrauwen@maastrichtuniversity.nl.'}]",Molecular metabolism,['10.1016/j.molmet.2018.04.004']
1321,31029230,"Effect of a behaviour change intervention on the quality of peri-urban sanitation in Lusaka, Zambia: a randomised controlled trial.","BACKGROUND


Poor sanitation in peri-urban areas is a growing public health problem. We tested a scalable, demand-side behaviour change intervention to motivate landlords to improve the quality of shared toilets within their plots.
METHODS


We did a residential plot-randomised controlled trial in a peri-urban community in Lusaka, Zambia. We enrolled adult resident landlords on plots where at least one tenant lived. We allocated landlords 1:1 to intervention and control arms on the basis of a random number sequence. The intervention was developed using the Behaviour Centred Design approach and consisted of a series of group meetings designed to motivate sanitation quality improvement as a way to build wealth and reduce on-plot conflict; no subsidies or materials were provided. The control group received no intervention. The four primary outcomes were having a rotational cleaning system in place (to improve hygiene); having a solid door on the toilet used by tenants with an inside lock (for privacy); having an outside lock (for security); and having a sealed toilet (to reduce smell and contamination). We measured outcomes 1 month before the start of the intervention and 4 months after the end of the intervention. Data collectors measuring outcomes were blinded to group assignment. We analysed outcomes by intention to treat, including all landlords with study-end results. Because the outcomes were assumed to not be independent, we used a family-wise error rate of 0·05 to calculate an adjusted significance level of 0·0253. This study was registered with ClinicalTrials.gov, number NCT03174015.
FINDINGS


Between June 9 and July 6, 2017, 1085 landlords were enrolled and randomly assigned to the intervention (n=543) or the control group (n=542). The intervention was delivered from Aug 1, 2017, and evaluated from Feb 15 to March 5, 2018. Analysis was based on the 474 intervention and 454 control landlords surveyed at study end. The intervention was associated with improvements in the prevalence of cleaning rotas (relative risk 1·16, 95% CI 1·05-1·30; p=0·0011), inside locks (1·34, 1·10-1·64; p=0·00081), outside locks (1·27, 1·06-1·52; p=0·0028), and toilets with simple covers or water seals (1·25, 1·04-1·50; p=0·0063).
INTERPRETATION


It is possible to improve the structural quality and cleanliness of shared sanitation by targeting landlords with a scalable, theory-driven behaviour change intervention without subsidy or provision of the relevant infrastructure.
FUNDING


Sanitation and Hygiene Applied Research for Equity.",2019,"inside locks (1·34, 1·10-1·64; p=0·00081), outside locks (1·27, 1·06-1·52; p=0·0028), and toilets with simple covers or water seals (1·25, 1·04-1·50; p=0·0063).
","['peri-urban sanitation in Lusaka, Zambia', 'Between June 9 and July 6, 2017, 1085 landlords were enrolled and randomly assigned to the intervention (n=543) or the control group (n=542', 'peri-urban community in Lusaka, Zambia']","['behaviour change intervention', 'no intervention']","['rotational cleaning system in place (to improve hygiene); having a solid door on the toilet used by tenants with an inside lock (for privacy); having an outside lock (for security); and having a sealed toilet (to reduce smell and contamination', 'prevalence of cleaning rotas']","[{'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0043445', 'cui_str': 'Republic of Zambia'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0445237', 'cui_str': 'Rotational (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}, {'cui': 'C0557698', 'cui_str': 'Door (physical object)'}, {'cui': 'C1140607', 'cui_str': 'Toilets'}, {'cui': 'C1273517', 'cui_str': 'Used by'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0080048', 'cui_str': 'Privacy'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0036492', 'cui_str': 'Seal (organism)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0998863', 'cui_str': 'Osmeridae'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}]",1085.0,0.115879,"inside locks (1·34, 1·10-1·64; p=0·00081), outside locks (1·27, 1·06-1·52; p=0·0028), and toilets with simple covers or water seals (1·25, 1·04-1·50; p=0·0063).
","[{'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Tidwell', 'Affiliation': 'Department of Disease Control, London School of Hygiene & Tropical Medicine, Keppel St, London, UK. Electronic address: ben.tidwell@lshtm.ac.uk.'}, {'ForeName': 'Jenala', 'Initials': 'J', 'LastName': 'Chipungu', 'Affiliation': 'Center for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Bosomprah', 'Affiliation': 'Center for Infectious Disease Research in Zambia, Lusaka, Zambia; Department of Biostatistics, School of Public Health, University of Ghana, Accra, Ghana.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Aunger', 'Affiliation': 'Department of Disease Control, London School of Hygiene & Tropical Medicine, Keppel St, London, UK.'}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Curtis', 'Affiliation': 'Department of Disease Control, London School of Hygiene & Tropical Medicine, Keppel St, London, UK.'}, {'ForeName': 'Roma', 'Initials': 'R', 'LastName': 'Chilengi', 'Affiliation': 'Center for Infectious Disease Research in Zambia, Lusaka, Zambia.'}]",The Lancet. Planetary health,['10.1016/S2542-5196(19)30036-1']
1322,31937653,Cost-utility analysis of transcranial direct current stimulation (tDCS) in non-treatment-resistant depression: the DISCO randomised controlled study protocol.,"INTRODUCTION


Depression is among the most widespread psychiatric disorders in France. Psychiatric disorders are associated with considerable social costs, amounting to €22.6 billion for treatment and psychotropic medication in 2011. Treatment as usual (TAU), mainly consisting of pharmacotherapy and psychotherapy, is effective for only a third of patients and in most cases fails to prevent treatment resistance and chronicity. Transcranial direct current stimulation (tDCS) consists in a non-invasive and painless application of low-intensity electric current to the cerebral cortex through the scalp. Having proved effective in depressed patients, it could be used in combination with TAU to great advantage. The objective is to compare, for the first time ever, the cost-utility of tDCS-TAU and of TAU alone for the treatment of a depressive episode that has been refractory to one or two drug treatments.
METHODS AND ANALYSIS


This paper, based on the DISCO study protocol, focuses on the design of a prospective, randomised, controlled, open-label multicentre economic study to be conducted in France. It will include 214 patients with unipolar or bipolar depression, assigning them to two parallel arms: group A (tDCS-TAU) and group B (TAU alone). The primary outcome is the incremental cost-effectiveness ratio, that is, the ratio of the difference in cost between each strategy to the difference in their effects. Their effects will be expressed as numbers of quality-adjusted life-years, determined through administration of the EuroQol Five-Dimension questionnaire over a 12-month period to patients (EQ-5D-5L). Expected benefits are the reduction of treatment resistance and suicidal ideation as well as social and professional costs of depression. Should depression-related costs fall significantly, tDCS might be considered an efficient treatment for depression.
ETHICS AND DISSEMINATION


This protocol has been approved by a French ethics committee, the CPP--Est IV (Comité de Protection des Personnes-Strasbourg). Data are to be published in peer-reviewed medical journals.
TRIAL REGISTRATION NUMBER


RCB 2018-A00474-51; NCT03758105.",2020,"Treatment as usual (TAU), mainly consisting of pharmacotherapy and psychotherapy, is effective for only a third of patients and in most cases fails to prevent treatment resistance and chronicity.","['214 patients with unipolar or bipolar depression', 'non-treatment-resistant depression']","['TAU', 'transcranial direct current stimulation (tDCS', 'Transcranial direct current stimulation (tDCS']",['incremental cost-effectiveness ratio'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443340', 'cui_str': 'Unipolar (qualifier value)'}, {'cui': 'C0005587', 'cui_str': 'Depression, Bipolar'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}]","[{'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",214.0,0.0691645,"Treatment as usual (TAU), mainly consisting of pharmacotherapy and psychotherapy, is effective for only a third of patients and in most cases fails to prevent treatment resistance and chronicity.","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Sauvaget', 'Affiliation': 'CHU de Nantes, Addictology and Liaison Psychiatry Department, Hospital University of Nantes, Nantes, France anne.sauvaget@chu-nantes.fr.'}, {'ForeName': 'Lydie', 'Initials': 'L', 'LastName': 'Lagalice', 'Affiliation': 'CHU de Nantes, Addictology and Liaison Psychiatry Department, Hospital University of Nantes, Nantes, France.'}, {'ForeName': 'Solène', 'Initials': 'S', 'LastName': 'Schirr-Bonnans', 'Affiliation': 'CHU de Nantes, Innovation Cell, Partnership and Innovation Department, Directorate of Medical Affairs and Research, University Hospital Centre Nantes, Nantes, France.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Volteau', 'Affiliation': 'CHU de Nantes, Section of Methodology and Biostatistics, University Hospital Centre Nantes, Nantes, Pays de la Loire, France.'}, {'ForeName': 'Morgane', 'Initials': 'M', 'LastName': 'Péré', 'Affiliation': 'CHU de Nantes, Section of Methodology and Biostatistics, University Hospital Centre Nantes, Nantes, Pays de la Loire, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Dert', 'Affiliation': 'CHU de Nantes, Innovation Cell, Partnership and Innovation Department, Directorate of Medical Affairs and Research, University Hospital Centre Nantes, Nantes, France.'}, {'ForeName': 'Annabelle', 'Initials': 'A', 'LastName': 'Rivalland', 'Affiliation': 'CHU de Nantes, Addictology and Liaison Psychiatry Department, Hospital University of Nantes, Nantes, France.'}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Tessier', 'Affiliation': 'CHU de Nantes, Addictology and Liaison Psychiatry Department, Hospital University of Nantes, Nantes, France.'}, {'ForeName': 'Adeline', 'Initials': 'A', 'LastName': 'Lepage', 'Affiliation': 'CHU de Nantes, Addictology and Liaison Psychiatry Department, Hospital University of Nantes, Nantes, France.'}, {'ForeName': 'Agathe', 'Initials': 'A', 'LastName': 'Tostivint', 'Affiliation': 'CHU de Nantes, Addictology and Liaison Psychiatry Department, Hospital University of Nantes, Nantes, France.'}, {'ForeName': 'Thibault', 'Initials': 'T', 'LastName': 'Deschamps', 'Affiliation': 'Nantes Université, CHU Nantes,Movement, Interactions, Performance (MIP), EA 4334, University of Nantes, Nantes, France.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Thomas-Ollivier', 'Affiliation': 'Nantes Université, CHU Nantes,Movement, Interactions, Performance (MIP), EA 4334, University of Nantes, Nantes, France.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Robin', 'Affiliation': 'Nantes Université, CHU Nantes,Movement, Interactions, Performance (MIP), EA 4334, University of Nantes, Nantes, France.'}, {'ForeName': 'Noémie', 'Initials': 'N', 'LastName': 'Pineau', 'Affiliation': 'Nantes Université, CHU Nantes,Movement, Interactions, Performance (MIP), EA 4334, University of Nantes, Nantes, France.'}, {'ForeName': 'Clémence', 'Initials': 'C', 'LastName': 'Cabelguen', 'Affiliation': 'CHU de Nantes, Addictology and Liaison Psychiatry Department, Hospital University of Nantes, Nantes, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bukowski', 'Affiliation': 'CHU de Nantes, Addictology and Liaison Psychiatry Department, Hospital University of Nantes, Nantes, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Guitteny', 'Affiliation': 'CHU de Nantes, Addictology and Liaison Psychiatry Department, Hospital University of Nantes, Nantes, France.'}, {'ForeName': 'Auxane', 'Initials': 'A', 'LastName': 'Beslot', 'Affiliation': 'CHU de Nantes, Addictology and Liaison Psychiatry Department, Hospital University of Nantes, Nantes, France.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Simons', 'Affiliation': 'CHU de Nantes, Addictology and Liaison Psychiatry Department, Hospital University of Nantes, Nantes, France.'}, {'ForeName': 'Hugopsy', 'Initials': 'H', 'LastName': 'Network', 'Affiliation': 'Réseau HUGOPSY, Université de Rennes, Rennes, France.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Vanelle', 'Affiliation': 'CHU de Nantes, Addictology and Liaison Psychiatry Department, Hospital University of Nantes, Nantes, France.'}, {'ForeName': 'Giordano', 'Initials': 'G', 'LastName': ""D'Urso"", 'Affiliation': 'Department of Neurosciences, Reproductive Sciences, and Odontostomatology, University of Naples Federico II, Napoli, Campania, Italy.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Bulteau', 'Affiliation': 'CHU de Nantes, Addictology and Liaison Psychiatry Department, Hospital University of Nantes, Nantes, France.'}, {'ForeName': 'Valéry-Pierre', 'Initials': 'VP', 'LastName': 'Riche', 'Affiliation': 'CHU de Nantes, Innovation Cell, Partnership and Innovation Department, Directorate of Medical Affairs and Research, University Hospital Centre Nantes, Nantes, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-033376']
1323,30975047,The impact of telehealth care on health-related quality of life of patients with heart failure: Results from the Danish TeleCare North heart failure trial.,"AIM


The aim of this study was to assess the impact on health-related quality of life (HRQoL) of a telehealth care solution compared with usual practice of patients with heart failure (HF).
METHODS


A randomized controlled trial with a telehealth care solution (Telekit) as the intervention (with a focus on self-empowerment achieved by engaging patients in their own illness through self-monitoring) combined with usual care and usual care as the control. The primary outcome was a change in HRQoL as measured by the Short Form-36 (SF-36) questionnaire Physical Component Summary (PCS) score. Secondary outcomes were changes in HRQoL as measured by the SF-36 questionnaire Mental Component Summary (MSC) score and the HF disease-specific questionnaire Kansas City Cardiomyopathy Questionnaire 12 (KCCQ12) score, all of which were assessed from baseline to approximately 12 months' follow-up between the two groups. Outcomes were assessed via unadjusted and adjusted analyses.
RESULTS


At baseline, 299 (145 interventions, 154 controls) patients were enrolled. In the primary analysis ( n  = 299), the adjusted intervention effects were PCS -0.81 (95% CI -2.7-1.1), MCS 4.66 (95% CI 1.8-7.5) and KCCQ12 3.67 (95% CI -0.7-8.1). Only the change in MCS was statistically significant. An unadjusted analysis replicated the primary analysis. Complete case analyses ( n  = 193) generally resulted in a lower intervention effect on the PCS score, but the difference remained statistically insignificant.
CONCLUSIONS


Only the MCS score was significantly higher in the telehealth care group compared to the control group. ClinicalTrials.gov (NCT02860013), July 28, 2016.",2019,"In the primary analysis ( n = 299), the adjusted intervention effects were PCS -0.81","['patients with heart failure (HF', '299 (145 interventions, 154 controls) patients were enrolled', 'patients with heart failure']","['telehealth care', 'telehealth care solution (Telekit']","['MCS score', 'health-related quality of life (HRQoL', 'change in HRQoL as measured by the Short Form-36 (SF-36) questionnaire Physical Component Summary (PCS) score', 'MCS', 'Cardiomyopathy Questionnaire 12 (KCCQ12) score', 'PCS score', 'changes in HRQoL as measured by the SF-36 questionnaire Mental Component Summary (MSC) score and the HF disease-specific questionnaire Kansas City']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]",,0.167949,"In the primary analysis ( n = 299), the adjusted intervention effects were PCS -0.81","[{'ForeName': 'Simon L', 'Initials': 'SL', 'LastName': 'Cichosz', 'Affiliation': 'Department of Health Science and Technology, Aalborg University, Denmark.'}, {'ForeName': 'Flemming W', 'Initials': 'FW', 'LastName': 'Udsen', 'Affiliation': 'Department of Health Science and Technology, Aalborg University, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Hejlesen', 'Affiliation': 'Department of Health Science and Technology, Aalborg University, Denmark.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19832713']
1324,30964778,EARLY VITAMIN A SUPPLEMENTATION IMPROVES THE OUTCOME OF RETINOPATHY OF PREMATURITY IN EXTREMELY PRETERM INFANTS.,"PURPOSE


This study assessed the efficacy and safety of early vitamin A (VA) supplementation to improve outcomes of retinopathy of prematurity in extremely preterm infants.
METHODS


A total of 262 eligible extremely preterm infants underwent randomization; of these, 132 were assigned to the VA group and 130 to the control group. The infants were administered a solution of VA (1,500 IU/day), added to their enteral feeds as soon as minimal feeding was introduced and continued for 28 days or until discharge.
RESULTS


With no adverse effects occurring, serum VA of the VA-supplemented infants on Days 14, 28, and postmenstrual 36 weeks was higher than that of the placebo group (P < 0.001). No signs of VA toxicity or increased intracranial pressure were reported. The VA group had lower unadjusted rates of Type 1 retinopathy of prematurity (1.6 vs. 6.9%, P = 0.030) and bronchopulmonary dysplasia (18.9 vs. 33.8%, P = 0.008) than the control group. Regression analysis revealed an association between serum VA levels and risk of Type 1 retinopathy of prematurity (beta = -2.37).
CONCLUSION


Vitamin A supplementation reduced VA deficiency in extremely preterm infants; it was associated with a decreased incidence of Type 1 retinopathy of prematurity and may also have a positive impact on reducing bronchopulmonary dysplasia.",2020,Vitamin A supplementation reduced VA deficiency in extremely preterm infants; it was associated with a decreased incidence of Type 1 retinopathy of prematurity and may also have a positive impact on reducing bronchopulmonary dysplasia.,"['extremely preterm infants', '262 eligible extremely preterm infants underwent randomization; of these, 132 were assigned to the VA group and 130 to the control group']","['early vitamin A (VA) supplementation', 'Vitamin A supplementation', 'solution of VA', 'placebo']","['unadjusted rates of Type 1 retinopathy of prematurity', 'VA toxicity or increased intracranial pressure', 'bronchopulmonary dysplasia', 'efficacy and safety']","[{'cui': 'C3494262', 'cui_str': 'Extremely Preterm Infants'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C4524019', 'cui_str': 'Vitamin A supplementation'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0035344', 'cui_str': 'Retrolental Fibroplasia'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0151740', 'cui_str': 'Intracranial Pressure Increase'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary Dysplasia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",262.0,0.227382,Vitamin A supplementation reduced VA deficiency in extremely preterm infants; it was associated with a decreased incidence of Type 1 retinopathy of prematurity and may also have a positive impact on reducing bronchopulmonary dysplasia.,"[{'ForeName': 'Huiqing', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Departments of Neonatology, and.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Cheng', 'Affiliation': ""Department of Neonatology, Children's Hospital of Nanjing Medical University, Nanjing, China.""}, {'ForeName': 'Zhansheng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Department of Neonatology, Shangqiu People's Hospital, Shangqiu, China.""}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002543']
1325,30862667,A Human TRPA1-Specific Pain Model.,"The cation channel transient receptor potential ankyrin 1 (TRPA1) plays an important role in sensing potentially hazardous substances. However, TRPA1 species differences are substantial and limit translational research. TRPA1 agonists tested previously in humans also have other targets. Therefore, the sensation generated by isolated TRPA1 activation in humans is unknown. The availability of 2-chloro -N- (4-(4-methoxyphenyl)thiazol-2-yl) -N- (3-methoxypropyl)-acetamide (JT010), a potent and specific TRPA1 agonist, allowed us to explore this issue. To corroborate the specificity of JT010, it was investigated whether the TRPA1 antagonist (1E,3E)-1-(4-fluorophenyl)-2-methyl-1-penten-3-one oxime (A-967079) abolishes JT010-elicited pain. Sixteen healthy volunteers of both sexes rated pain due to intraepidermal injections of different concentrations and combinations of the substances. The study design was a double-blind crossover study. All subjects received all types of injections, including a placebo without substances. Injections of the TRPA1 agonist dose-dependently caused pain with a half-maximal effective concentration of 0.31 μm Coinjection of A-967079 dose-dependently reduced and at a high concentration abolished JT010-induced pain. Quantification of JT010 by HPLC showed that a substantial part is adsorbed when in contact with polypropylene surfaces, but that this was overcome by handling in glass vials and injection using glass syringes. Isolated TRPA1 activation in humans causes pain. Thus, intradermal JT010 injection can serve as a tool to validate new TRPA1 antagonists concerning target engagement. More importantly, TRPA1-specific tools allow quantification of the TRPA1-dependent component in physiology and pathophysiology. SIGNIFICANCE STATEMENT  This study showed that activation of the ion channel transient receptor potential ankyrin 1 (TRPA1) alone indeed suffices to elicit pain in humans, independent of other receptors previously found to be involved in pain generation. The newly established TRPA1-specific pain model allows different applications. First, it can be tested whether diseases are associated with compromised or exaggerated TRPA1-dependent painful sensations in the skin. Second, it can be investigated whether a new, possibly systemically applied drug directed against TRPA1 engages its target in humans. Further, the general possibility of quantitative inhibition of TRPA1 allows identification of the TRPA1-dependent disease component, given that the substance reaches its target. This contributes to a better understanding of pathophysiology, can lay the basis for new therapeutic approaches, and can bridge the gap between preclinical research and clinical trials.",2019,The cation channel transient receptor potential ankyrin 1 (TRPA1) plays an important role in sensing potentially hazardous substances.,['Sixteen healthy volunteers of both sexes rated pain'],"['2-chloro -N- (4-(4-methoxyphenyl)thiazol-2-yl) -N', 'placebo without substances', '3-methoxypropyl)-acetamide (JT010', 'TRPA1 antagonist (1E,3E)-1-(4-fluorophenyl)-2-methyl-1-penten-3-one oxime']",['pain'],"[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0050423', 'cui_str': 'acetamide'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0030020', 'cui_str': 'Hydroxyimino Compounds'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}]",16.0,0.0439185,The cation channel transient receptor potential ankyrin 1 (TRPA1) plays an important role in sensing potentially hazardous substances.,"[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Heber', 'Affiliation': 'Institutes of Physiology, stefan.heber@meduniwien.ac.at.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Gold-Binder', 'Affiliation': 'Institutes of Physiology.'}, {'ForeName': 'Cosmin I', 'Initials': 'CI', 'LastName': 'Ciotu', 'Affiliation': 'Institutes of Physiology.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Witek', 'Affiliation': 'Pharmacology, Center for Physiology and Pharmacology, and.'}, {'ForeName': 'Nino', 'Initials': 'N', 'LastName': 'Ninidze', 'Affiliation': 'Division of Special Anesthesia and Pain Medicine, Department of Anesthesia, Intensive Care and Pain Medicine, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Hans-Georg', 'Initials': 'HG', 'LastName': 'Kress', 'Affiliation': 'Division of Special Anesthesia and Pain Medicine, Department of Anesthesia, Intensive Care and Pain Medicine, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Michael J M', 'Initials': 'MJM', 'LastName': 'Fischer', 'Affiliation': 'Institutes of Physiology.'}]",The Journal of neuroscience : the official journal of the Society for Neuroscience,['10.1523/JNEUROSCI.3048-18.2019']
1326,31722536,Impact of Autonomic Regulation Therapy in Patients with Heart Failure: ANTHEM-HFrEF Pivotal Study Design.,"BACKGROUND


The ANTHEM-HFrEF (Autonomic Regulation Therapy to Enhance Myocardial Function and Reduce Progression of Heart Failure with Reduced Ejection Fraction) pivotal study is an adaptive, open-label, randomized, controlled study evaluating whether autonomic regulation therapy will benefit patients with advanced HFrEF. While early-phase studies have supported potential use of vagus nerve stimulation to deliver autonomic regulation therapy for HFrEF, results of larger clinical trials have been inconsistent. The ANTHEM-HFrEF study uses a novel design, with adaptive sample size selection, evaluating effects on morbidity and mortality as well as symptoms and function.
METHODS


The ANTHEM-HFrEF study will randomize patients (2:1) to autonomic regulation therapy plus guideline-directed medical therapy, or guideline-directed medical therapy alone. The morbidity and mortality trial utilizes a conventional frequentist approach for analysis of the primary outcome end point-reduction in the composite of cardiovascular death or first HF hospitalization-and a Bayesian adaptive approach toward sample size selection. Embedded within the ANTHEM-HFrEF study is a second trial evaluating improvement in symptoms and function. Symptom/function success will require meeting 2 risk-related conditions (trend for reduced cardiovascular death/HF hospitalization and sufficient freedom from device-related serious adverse events) and 3 efficacy end point components (changes in left ventricular EF, 6-minute walk distance, and Kansas City Cardiomyopathy Questionnaire overall score).
CONCLUSIONS


Vagus nerve stimulation remains a promising, yet unproven treatment in HFrEF. A successful ANTHEM-HFrEF pivotal study would provide an important advance in HFrEF treatment and offer a model for expediting evaluation of new therapies.
CLINICAL TRIAL REGISTRATION


URL: http://www.clinicaltrials.gov. Unique identifier: NCT03425422.",2019,"BACKGROUND


The ANTHEM-HFrEF (Autonomic Regulation Therapy to Enhance Myocardial Function and Reduce Progression of Heart Failure with Reduced Ejection Fraction)","['Heart Failure with Reduced Ejection Fraction', 'patients with advanced HFrEF', 'Patients with Heart Failure']","['Autonomic Regulation Therapy', 'autonomic regulation therapy plus guideline-directed medical therapy, or guideline-directed medical therapy alone', 'autonomic regulation therapy']","['efficacy end point components (changes in left ventricular EF, 6-minute walk distance, and Kansas City Cardiomyopathy Questionnaire overall score', 'morbidity and mortality']","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}]","[{'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0928951,"BACKGROUND


The ANTHEM-HFrEF (Autonomic Regulation Therapy to Enhance Myocardial Function and Reduce Progression of Heart Failure with Reduced Ejection Fraction)","[{'ForeName': 'Marvin A', 'Initials': 'MA', 'LastName': 'Konstam', 'Affiliation': 'The CardioVascular Center at Tufts Medical Center, Boston, MA (M.A.K., J.E.U.).'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Udelson', 'Affiliation': 'The CardioVascular Center at Tufts Medical Center, Boston, MA (M.A.K., J.E.U.).'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson, MS (J.B.).'}, {'ForeName': 'Helmut U', 'Initials': 'HU', 'LastName': 'Klein', 'Affiliation': 'Department of Medicine, University of Rochester Medical Center, NY (H.U.K.).'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Parker', 'Affiliation': 'University of Toronto, Mount Sinai Hospital, Division of Cardiology, Sinai Health Systems and University Health Network, Toronto, Canada (J.D.P.).'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Teerlink', 'Affiliation': 'Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California (J.R.T.).'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Wedge', 'Affiliation': 'Cardiovascular Clinical Science Foundation, Boston, MA (P.M.W.).'}, {'ForeName': 'Benjamin R', 'Initials': 'BR', 'LastName': 'Saville', 'Affiliation': 'Berry Consultants LLC, Austin TX and Department of Biostatistics, Vanderbilt University, Nashville TN (B.R.S.).'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Ardell', 'Affiliation': 'Neurocardiology Center, University of California, Los Angeles (J.L.A.).'}, {'ForeName': 'Imad', 'Initials': 'I', 'LastName': 'Libbus', 'Affiliation': 'LivaNova USA Incorporated, Houston, TX (I.L., L.A.D.).'}, {'ForeName': 'Lorenzo A', 'Initials': 'LA', 'LastName': 'DiCarlo', 'Affiliation': 'LivaNova USA Incorporated, Houston, TX (I.L., L.A.D.).'}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.119.005879']
1327,31012375,*The efficacy of the attachment-based SAFE® prevention program: a randomized control trial including mothers and fathers.,"SAFE® is a primary prevention program to promote secure infant-parent attachment. SAFE explicitly addresses mothers and fathers. In this current first study, efficacy was assessed in a low-risk German sample using a randomized control trial with an active control intervention. A high rate of fathers' participation was achieved: in SAFE 84.6% and in the control group intervention 73.9% of the fathers participated. Infant-parent attachment was assessed at the end of the year-long programs. There was a significant difference between groups in terms of secure infant-father attachment, but not of infant-mother attachment. In SAFE, 84.6% of the infants were securely attached to their father (n = 39), in comparison to 65.8% in the control group (n = 38). The proportion of secure infant-mother attachment was 66.7% in the SAFE group (n = 54) and 64.0% in the control group (n = 50). The program was successful in promoting infant-father attachment security.",2019,"There was a significant difference between groups in terms of secure infant-father attachment, but not of infant-mother attachment.",['mothers and fathers'],"['active control intervention', 'attachment-based SAFE® prevention program']","['secure infant-father attachment', 'proportion of secure infant-mother attachment']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0015671', 'cui_str': 'Fathers'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0015671', 'cui_str': 'Fathers'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]",54.0,0.0401459,"There was a significant difference between groups in terms of secure infant-father attachment, but not of infant-mother attachment.","[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Walter', 'Affiliation': ""a Department of Pediatric Psychosomatic Medicine and Psychotherapy, Dr. von Hauner Children's Hospital, University Hospital LMU Munich , Munich , Germany.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Landers', 'Affiliation': ""a Department of Pediatric Psychosomatic Medicine and Psychotherapy, Dr. von Hauner Children's Hospital, University Hospital LMU Munich , Munich , Germany.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Quehenberger', 'Affiliation': ""a Department of Pediatric Psychosomatic Medicine and Psychotherapy, Dr. von Hauner Children's Hospital, University Hospital LMU Munich , Munich , Germany.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Carlson', 'Affiliation': 'b Department of Psychiatry, University of Minnesota , Minneapolis , MN , USA.'}, {'ForeName': 'K H', 'Initials': 'KH', 'LastName': 'Brisch', 'Affiliation': ""a Department of Pediatric Psychosomatic Medicine and Psychotherapy, Dr. von Hauner Children's Hospital, University Hospital LMU Munich , Munich , Germany.""}]",Attachment & human development,['10.1080/14616734.2019.1582599']
1328,30995574,"Evaluation of the impact of antimicrobial hand towels on hand contamination with Escherichia coli among mothers in Kisumu County, Kenya, 2011-2012.","Poor hand hygiene contributes to diarrhea in developing countries. Handwashing with soap reduces diarrhea risk, but drying hands on contaminated towels can compromise the benefits of handwashing. In response to the challenge of keeping hands clean, an antimicrobial hand towel was developed and shown to be promising in the laboratory, but has not been adequately tested in the field. We evaluated the effectiveness of an antimicrobial towel in two randomized, double-blinded crossover trials among mothers with children<5 years old in 125 households in western Kenya. In trial 1, we randomly assigned mothers to use either the treated towel or an identical untreated (placebo) towel and made surprise home visits at random times once a week for three weeks. At each visit, we tested hands for Escherichia coli using sterile hand rinses, then switched towel types in the two groups and repeated three weekly rounds of E. coli testing. In crossover trial 2, we compared E. coli contamination of maternal hands immediately following three different handwashing/drying procedures: soap and water + treated towel, water only + treated towel, and soap and water + air dry. There was no statistically significant difference in the level of E. coli contamination on maternal hands by type of towel used during trial 1 (odds ratio for treated vs untreated towel: 1.14, 95% confidence interval 0.83-1.56). In trial 2, there were no significant differences in E. coli contamination of maternal hands by handwashing/drying procedure. In these trials, use of antimicrobial hand towels did not prevent E. coli contamination of mothers' hands in Kenyan households during random testing and offered no advantages over standard handwashing and drying practices. Handwashing with soap and clean water and drying with clean towels are recommended.",2019,"In trial 2, there were no significant differences in E. coli contamination of maternal hands by handwashing/drying procedure.","['mothers with children<5 years old in 125 households in western Kenya', 'mothers in Kisumu County, Kenya, 2011-2012']","['treated towel or an identical untreated (placebo', 'handwashing/drying procedures: soap and water\xa0+\xa0treated towel, water only\xa0+\xa0treated towel, and soap and water\xa0+\xa0air dry']","['level of E.\xa0coli contamination', 'diarrhea risk']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}]","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0336616', 'cui_str': 'Towel, device (physical object)'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0001861', 'cui_str': 'Air'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",125.0,0.14437,"In trial 2, there were no significant differences in E. coli contamination of maternal hands by handwashing/drying procedure.","[{'ForeName': 'Sunkyung', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Division of Foodborne, Waterborne, and Environmental Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA. Electronic address: wox0@cdc.gov.'}, {'ForeName': 'Allison C', 'Initials': 'AC', 'LastName': 'Brown', 'Affiliation': 'Division of Foodborne, Waterborne, and Environmental Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Murphy', 'Affiliation': 'Division of Foodborne, Waterborne, and Environmental Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Oremo', 'Affiliation': 'Safe Water and AIDS Project, Kisumu, Kenya.'}, {'ForeName': 'Mercy', 'Initials': 'M', 'LastName': 'Owuor', 'Affiliation': 'Safe Water and AIDS Project, Kisumu, Kenya.'}, {'ForeName': 'Rosebel', 'Initials': 'R', 'LastName': 'Ouda', 'Affiliation': 'Safe Water and AIDS Project, Kisumu, Kenya.'}, {'ForeName': 'Bobbie', 'Initials': 'B', 'LastName': 'Person', 'Affiliation': 'Division of Foodborne, Waterborne, and Environmental Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Quick', 'Affiliation': 'Division of Foodborne, Waterborne, and Environmental Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}]",Water research,['10.1016/j.watres.2019.03.085']
1329,31720889,A Randomized Control Trial of Thromboelastography-Guided Transfusion in Cirrhosis for High-Risk Invasive Liver-Related Procedures.,"BACKGROUND AND AIM


Hemostasis in cirrhosis is dynamic and balanced. Thromboelastography (TEG) assesses global coagulation status. We aimed to assess whether TEG-guided blood product transfusions result in lower blood product requirements in patients with cirrhosis undergoing invasive liver-related procedures as compared to the conventional standard of care (SOC).
METHODS


In this open-label, randomized controlled trial, cirrhosis patients with coagulopathy, undergoing invasive liver-related procedures, were randomized to either TEG-guided blood product transfusion or SOC. The primary outcome was difference in the amount of fresh frozen plasma (FFP) and platelet units transfused between the two groups. The secondary outcome was procedure-related bleeding complications within 5 days and any complications until 28 days.
RESULTS


From November 2017 till June 2019, 58 patients were recruited (29: TEG and 29: SOC). Most common procedures performed were percutaneous liver biopsy (n = 48), followed by transjugular intrahepatic portosystemic shunt (n = 2), percutaneous acetic acid injection (n = 2), and transarterial chemoembolization (n = 2). There were no differences in baseline demographics, hemostatic profile, and types of procedures between the two groups. Only nine patients in TEG group received transfusions compared to all patients in SOC (31% vs 100%; P < 0.001). In TEG group, six (20.7%) received FFP (P = 0.753 vs. SOC), two (6.9%) received platelets (P < 0.001 vs. SOC), and 1(3.4%) patient received both FFP and platelet (P ≥ 0.999 vs. SOC) transfusion. None of the patients in either group developed procedure-related bleeding complications until 5 days post-procedure. The complication rates at 28-day follow-up were similar between the groups.
CONCLUSION


TEG-guided blood product transfusion strategy reduces blood product transfusion without increased risk of bleeding in cirrhotic patients undergoing invasive liver-related procedures (CTRI/2017/12/010822).",2020,Only nine patients in TEG group received transfusions compared to all patients in SOC (31% vs 100%; P < 0.001).,"['patients with cirrhosis undergoing invasive liver-related procedures', 'From November 2017 till June 2019, 58 patients were recruited (29: TEG and 29: SOC', 'cirrhotic patients undergoing invasive liver-related procedures (CTRI/2017/12/010822', 'cirrhosis patients with coagulopathy, undergoing invasive liver-related procedures', 'Cirrhosis for High-Risk Invasive Liver-Related Procedures']","['transjugular intrahepatic portosystemic shunt', 'TEG', 'TEG-guided blood product transfusions', 'TEG-guided blood product transfusion strategy', 'TEG-guided blood product transfusion or SOC', 'percutaneous liver biopsy', 'Thromboelastography (TEG', 'Thromboelastography-Guided Transfusion', 'percutaneous acetic acid injection', 'transarterial chemoembolization']","['FFP', 'amount of fresh frozen plasma (FFP) and platelet units transfused', 'complication rates', 'procedure-related bleeding complications', 'baseline demographics, hemostatic profile, and types of procedures']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0439686', 'cui_str': 'Cirrhotic (qualifier value)'}, {'cui': 'C0005779', 'cui_str': 'Blood Coagulation Disorders'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C1301416', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0005841', 'cui_str': 'Blood Transfusion'}, {'cui': 'C0558534', 'cui_str': 'Percutaneous liver biopsy (procedure)'}, {'cui': 'C0040017', 'cui_str': 'Thromboelastography'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0766298', 'cui_str': '(methylsulfanyl)acetic acid'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0522522', 'cui_str': 'Transarterial approach (qualifier value)'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}]","[{'cui': 'C0016709', 'cui_str': 'Fresh frozen plasma (product)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0019120', 'cui_str': 'Hemostatics'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]",58.0,0.188769,Only nine patients in TEG group received transfusions compared to all patients in SOC (31% vs 100%; P < 0.001).,"[{'ForeName': 'Sudheer K', 'Initials': 'SK', 'LastName': 'Vuyyuru', 'Affiliation': 'Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Achintya D', 'Initials': 'AD', 'LastName': 'Singh', 'Affiliation': 'Department of Internal Medicine, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Shivanand R', 'Initials': 'SR', 'LastName': 'Gamanagatti', 'Affiliation': 'Department of Radiodiagnosis, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Gyanranjan', 'Initials': 'G', 'LastName': 'Rout', 'Affiliation': 'Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Gunjan', 'Affiliation': 'Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Shalimar', 'Affiliation': 'Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India. drshalimar@yahoo.com.'}]",Digestive diseases and sciences,['10.1007/s10620-019-05939-2']
1330,31721053,Tinzaparin Sodium Pharmacokinetics in Patients with Chronic Kidney Disease: Practical Implications.,"Low-molecular-weight heparins (LMWHs) are the mainstay of the prophylaxis and treatment of venous thromboembolism (VTE). Due to their renal elimination, the risk of accumulation with the related bleeding risk may represent a limitation for the use of LMWHs in patients with chronic kidney disease (CKD) as the risk of major bleeding is increased in patients with creatinine clearance (CrCl) < 30 mL/min, especially in patients with cancer. LMWH structure and molecular weight (MW) are heterogeneous among available agents. The elimination of tinzaparin, which has the highest mean MW among LMWHs, is less dependent on renal function as it is also metabolized through the reticuloendothelial system. A subcutaneous therapeutic dose of tinzaparin (175 IU/kg) once daily has been shown to cause no accumulation of anti-factor Xa activity in patients with CrCl ≥ 20 mL/min. Clinical experience from randomized controlled studies has shown no significant impact of CKD on bleeding risk in cancer patients receiving treatment doses of tinzaparin. This suggests that in these patients the use of treatment doses of tinzaparin does not require anticoagulation monitoring or dose adjustment.",2020,"The elimination of tinzaparin, which has the highest mean MW among LMWHs, is less dependent on renal function as it is also metabolized through the reticuloendothelial system.","['patients with chronic kidney disease (CKD', 'patients with creatinine clearance (CrCl) ', 'Patients with Chronic Kidney Disease', 'patients with CrCl ≥', 'patients with cancer', 'cancer patients receiving treatment doses of']","['Tinzaparin Sodium Pharmacokinetics', 'CKD', 'tinzaparin', 'Low-molecular-weight heparins (LMWHs']","['LMWH structure and molecular weight (MW', 'bleeding risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0354599', 'cui_str': 'Tinzaparin sodium'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0216278', 'cui_str': 'tinzaparin'}, {'cui': 'C0019139', 'cui_str': 'LMWH'}]","[{'cui': 'C0019139', 'cui_str': 'LMWH'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.0136101,"The elimination of tinzaparin, which has the highest mean MW among LMWHs, is less dependent on renal function as it is also metabolized through the reticuloendothelial system.","[{'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Helfer', 'Affiliation': 'Hôpital Louis-Mourier, Service de Médecine Interne (APHP), Université Paris Diderot, Université de Paris, Colombes, France.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Siguret', 'Affiliation': ""Service d'Hématologie biologique, Hôpital Lariboisière (APHP), Paris, France.""}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Mahé', 'Affiliation': 'Hôpital Louis-Mourier, Service de Médecine Interne (APHP), Université Paris Diderot, Université de Paris, Colombes, France. isabelle.mahe@aphp.fr.'}]","American journal of cardiovascular drugs : drugs, devices, and other interventions",['10.1007/s40256-019-00382-0']
1331,31718499,Impact of a Design-Based Bike Exergame on Young Adults' Physical Activity Metrics and Situational Interest.,"Purpose : Despite the benefits of commercial exergames, in the practical application, players might not be spending sufficient time in physical activity levels compatible with health outcomes. We adopted a design-based exergame approach to build a bike exergame called Greedy Rabbit. The purpose of this study was to identify the impact of Greedy Rabbit on players' physical activity metrics and situational interest.  Method : Sixty undergraduate students were assigned to two groups: an experimental group playing Greedy Rabbit (N = 41) and a control group playing a placebo version of Greedy Rabbit (N = 19). The physical activity metrics measured were maximum oxygen consumption, heart rate and cadence.  Results : The experimental group reported higher scores for all physical activity metrics and for two dimensions of situational interest (instant enjoyment and attention demand). Furthermore, the physical activity metrics increased more during the exergame for the experimental group, reaching the standard guidelines for vigorous physical activity.  Conclusion : This study demonstrated that a design-based bike exergame might be a good option to enhance players' health-related physical activity outcomes and situational interest.",2020,The experimental group reported higher scores for all physical activity metrics and for two dimensions of situational interest (instant enjoyment and attention demand).,"['Sixty undergraduate students', 'Young Adults']","['Design-Based Bike Exergame', 'control group playing a placebo version of Greedy Rabbit', 'experimental group playing Greedy Rabbit']","['maximum oxygen consumption, heart rate and cadence', 'Physical Activity Metrics and Situational Interest', 'situational interest (instant enjoyment and attention demand', 'physical activity metrics']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0005375', 'cui_str': 'Bicycle, device (physical object)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C3887509', 'cui_str': 'Rabbits'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0246847,The experimental group reported higher scores for all physical activity metrics and for two dimensions of situational interest (instant enjoyment and attention demand).,"[{'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Roure', 'Affiliation': 'University of Teacher Education.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Pasco', 'Affiliation': 'University of Bourgogne Franche-Comté.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Benoît', 'Affiliation': 'Université Catholique de Louvain.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Deldicque', 'Affiliation': 'Université Catholique de Louvain.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2019.1665621']
1332,30977081,Prognostic factors that modify outcomes of vestibular rehabilitation in elderly patients with falls.,"BACKGROUND


Our previous study has shown that vestibular rehabilitation (VR) is an effective technique to reduce falls in elderly patients. It would be interesting to establish patients' clinical characteristics in which vestibular rehabilitation is expected to be more effective.
AIMS


Evaluate factors that could modify rehabilitation outcomes in elderly patients with previous falls.
METHODS


Fifty-seven patients randomized to one of the intervention group (computerized dynamic posturography-CDP-training, optokinetic stimulus or exercise at home) and with previous falls were analyzed. Patients were assessed with objective outcome measures (sensorial organization test and limits of stability-LOS-of CDP, modified timed up and go test-TUG-and number of falls) and with subjective outcome measures (dizziness handicap inventory and Short falls efficacy scale-international-Short FES-I) during a 12-month follow-up period.
RESULTS


In the logistic regression model, a worse score in the maximum excursion (MXM), and a shorter time in the TUG significantly associated with a reduction > 50% of falls. Also, association with a higher score in the Short FES-I was close to a statistical significance. There was no statistical significance association with other covariables.
DISCUSSION


In patients with reduced limits of stability, VR seems to be more effective and they should be encouraged to perform it. But on the other hand, patients with longer time in the TUG show worse outcomes and may benefit more with gait training.
CONCLUSIONS


VR in elderly people with previous falls is effective regardless of their age and gender.",2020,"Also, association with a higher score in the Short FES-I was close to a statistical significance.","['elderly people with previous falls', 'elderly patients with falls', 'Fifty-seven patients randomized to one of the', 'elderly patients', 'elderly patients with previous falls']","['vestibular rehabilitation (VR', 'vestibular rehabilitation', 'intervention group (computerized dynamic posturography-CDP-training, optokinetic stimulus or exercise at home']","['objective outcome measures (sensorial organization test and limits of stability-LOS-of CDP, modified timed up and go test-TUG-and number of falls) and with subjective outcome measures (dizziness handicap inventory and Short falls efficacy scale-international-Short FES-I']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517815', 'cui_str': '57'}]","[{'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0919611', 'cui_str': 'Posturography'}, {'cui': 'C0010724', 'cui_str': 'CDP'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0220885', 'cui_str': 'organization'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0010724', 'cui_str': 'CDP'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2919878', 'cui_str': 'Short falls efficacy scale - international (assessment scale)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0674267', 'cui_str': 'greigite'}]",57.0,0.0261737,"Also, association with a higher score in the Short FES-I was close to a statistical significance.","[{'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Rossi-Izquierdo', 'Affiliation': 'Department of Otolaryngology, University Hospital Lucus Augusti, Calle Dr. Ulises Romero, 1, 27003, Lugo, Spain. Marcos_Rossi@hotmail.com.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Gayoso-Diz', 'Affiliation': 'Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Sofía', 'Initials': 'S', 'LastName': 'Santos-Pérez', 'Affiliation': 'Department of Otolaryngology, Complexo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Del-Río-Valeiras', 'Affiliation': 'Department of Otolaryngology, Complexo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Faraldo-García', 'Affiliation': 'Department of Otolaryngology, Complexo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Vaamonde-Sánchez-Andrade', 'Affiliation': 'Department of Otolaryngology, Complexo Hospitalario Universitario de Ourense, Orense, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Lirola-Delgado', 'Affiliation': 'Department of Otolaryngology, Complexo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Soto-Varela', 'Affiliation': 'Department of Otolaryngology, Complexo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela, Spain.'}]",Aging clinical and experimental research,['10.1007/s40520-019-01185-8']
1333,30977377,The value of prednisolone acetate provocative test before intravitreal triamcinolone acetonide injections.,"PURPOSE


The aim of this study was to investigate the diagnostic value of a topical prednisolone acetate 1% provocative test for steroid-induced ocular hypertension before intravitreal triamcinolone acetonide injection.
METHODS


This is a prospective, single-center, randomized controlled study at Kasr El Aini Hospital, Cairo University. Patients scheduled for intravitreal triamcinolone acetonide were enrolled and randomly allocated in a ratio 2:1 to either Group A: received prednisolone acetate provocative test and those who did not develop SIOH proceeded with intravitreal triamcinolone acetonide or Group B: did not receive prednisolone acetate provocative test and proceeded directly to intravitreal triamcinolone acetonide. Intraocular pressures were measured weekly for 4 weeks following intravitreal triamcinolone acetonide. Steroid-induced ocular hypertension is defined as intraocular pressure increase of 5 mmHg or more from baseline after prednisolone acetate provocative test or intravitreal triamcinolone acetonide.
RESULTS


A total of 66 eyes (66 patients) were included. Of which, 10 eyes (23.8%) showed prednisolone acetate provocative test steroid-induced ocular hypertension during the 4-week period. Intravitreal triamcinolone acetonide steroid-induced ocular hypertension was less likely to develop in Group A (prednisolone acetate provocative test non-steroid-induced ocular hypertension, n = 32, 31.25%) than in group B (n = 24, 54.2%) (p = 0.006, odds ratio: 0.178, 95% CI: 0.53-0.596). Our test achieved a negative predictive value of 68.75%.
CONCLUSION


The topical prednisolone acetate provocative test may be a useful method to predict a steroid-induced ocular hypertension following intravitreal triamcinolone acetonide.",2019,"Intravitreal triamcinolone acetonide steroid-induced ocular hypertension was less likely to develop in Group A (prednisolone acetate provocative test non-steroid-induced ocular hypertension, n = 32, 31.25%) than in group B (n = 24, 54.2%) (p = 0.006, odds ratio: 0.178, 95% CI: 0.53-0.596).","['A total of 66 eyes (66 patients) were included', 'Kasr El Aini Hospital, Cairo University']","['triamcinolone acetonide', 'topical prednisolone acetate', 'prednisolone acetate provocative test', 'Intravitreal triamcinolone acetonide steroid', 'intravitreal triamcinolone acetonide', 'triamcinolone acetonide injections', 'prednisolone acetate provocative test and those who did not develop SIOH proceeded with intravitreal triamcinolone acetonide']","['ocular hypertension', 'Intraocular pressures', 'prednisolone acetate provocative test steroid-induced ocular hypertension']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]","[{'cui': 'C0040866', 'cui_str': 'Triamcinolone Acetonide'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0071839', 'cui_str': 'prednisolone acetate'}, {'cui': 'C0201784', 'cui_str': 'Provocative test (procedure)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C0028840', 'cui_str': 'Ocular Hypertension'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0071839', 'cui_str': 'prednisolone acetate'}, {'cui': 'C0201784', 'cui_str': 'Provocative test (procedure)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]",,0.0141427,"Intravitreal triamcinolone acetonide steroid-induced ocular hypertension was less likely to develop in Group A (prednisolone acetate provocative test non-steroid-induced ocular hypertension, n = 32, 31.25%) than in group B (n = 24, 54.2%) (p = 0.006, odds ratio: 0.178, 95% CI: 0.53-0.596).","[{'ForeName': 'Aya Mohammed', 'Initials': 'AM', 'LastName': 'Saady', 'Affiliation': 'Department of Ophthalmology, Kasr El Aini Hospital, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Heba M', 'Initials': 'HM', 'LastName': 'Fouad', 'Affiliation': 'Department of Ophthalmology, Kasr El Aini Hospital, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Abdussalam M', 'Initials': 'AM', 'LastName': 'Abdullatif', 'Affiliation': 'Department of Ophthalmology, Kasr El Aini Hospital, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Youssef A H', 'Initials': 'YAH', 'LastName': 'Helmy', 'Affiliation': 'Department of Ophthalmology, Kasr El Aini Hospital, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Tamer A', 'Initials': 'TA', 'LastName': 'Macky', 'Affiliation': 'Department of Ophthalmology, Kasr El Aini Hospital, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Mansour', 'Affiliation': 'Department of Ophthalmology, Kasr El Aini Hospital, Cairo University, Cairo, Egypt.'}]",European journal of ophthalmology,['10.1177/1120672119842731']
1334,30980218,Give Me Five? Examining the Psychophysiological Effects of High-Fives in Athletes.,"High-fives are a phenomenon that is frequently observed in sports. However, investigations on effects of high-fives are missing. Therefore, the aim of the present study was to examine psychophysiological effects of high-fives. From an embodied cognition perspective, dynamic, upward movements compared to downward movements should activate positive concepts that are represented by psychological as well as physiological states. Thirty-four athletes performed high- and low-fives (dynamic movements) as opposed to high and low static postures (control conditions) in a double-blind, within-subject design. Psychological states (i.e., feeling motivated, feeling strong) and physiological changes (i.e., cortisol, testosterone) due to the manipulation were measured. Results showed the predicted significant interaction effect for cortisol changes, but not for the other psychological (i.e., feeling motivated, feeling strong) and physiological (testosterone) state measures. In detail, a decrease in cortisol was found after athletes performed high-fives compared to low-fives. The observed effect on cortisol should be considered with caution and needs to be replicated, however, might add information to the current discussion about the crucial relevance of movement for embodied cognition effects. Future research could investigate the effects of high-fives with a partner and add performance parameters to provide more information on the effects of high-fives on performance in sport.",2019,"Results showed the predicted significant interaction effect for cortisol changes, but not for the other psychological (i.e., feeling motivated, feeling strong) and physiological (testosterone) state measures.",['Athletes'],['high- and low-fives (dynamic movements) as opposed to high and low static postures (control conditions'],"['cortisol', 'psychological (i.e., feeling motivated, feeling strong) and physiological (testosterone) state measures', 'Psychological states (i.e., feeling motivated, feeling strong) and physiological changes (i.e., cortisol, testosterone']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1533153', 'cui_str': 'Fives'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}]",34.0,0.0406808,"Results showed the predicted significant interaction effect for cortisol changes, but not for the other psychological (i.e., feeling motivated, feeling strong) and physiological (testosterone) state measures.","[{'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Lautenbach', 'Affiliation': 'Institute of Psychology, German Sport University Cologne, Am Sportpark Muengersdorf 6, 50933, Cologne, Germany. Franziska.Lautenbach@uni-leipzig.de.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Jeraj', 'Affiliation': 'Institute of Psychology, German Sport University Cologne, Am Sportpark Muengersdorf 6, 50933, Cologne, Germany.'}, {'ForeName': 'Jonna', 'Initials': 'J', 'LastName': 'Loeffler', 'Affiliation': 'Institute of Psychology, German Sport University Cologne, Am Sportpark Muengersdorf 6, 50933, Cologne, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Musculus', 'Affiliation': 'Institute of Psychology, German Sport University Cologne, Am Sportpark Muengersdorf 6, 50933, Cologne, Germany.'}]",Applied psychophysiology and biofeedback,['10.1007/s10484-019-09435-1']
1335,31711154,Feasibility and acceptability of an intervention for enhancing reintegration in adults with experience of homelessness.,"BACKGROUND


Service centres for homeless adults are potential settings for implementation of reintegration interventions. This study aimed to evaluate (i) the acceptability of a group-based programme among individuals from the broad population of homeless people and (ii) if a future study of its feasibility and acceptability for re-housed homeless people is warranted.
METHODS


Recruiting participants and intervention facilitators from partnering service centres was thought to improve recruitment and retention, cost-effectiveness and social interactions compared to professional-led interventions. Seven adults with experience of homelessness (three females, four males, mean age 39 years, range 18-63) were recruited to participate in the intervention. The research protocol comprised completion pre/post of scales [Recovering Quality of Life questionnaire; Working Alliance Inventory-short form revised (WAI-SR)] and focus groups, and WAI-SR and focus groups after sessions 3 and 6.
RESULTS


The intervention and research protocols were feasible, with all participants engaging in all sessions, completing all scales and attending all focus groups. The quantitative data demonstrated the feasibility of obtaining practically useful measures of relevant outcomes. In the four focus groups, the intervention received very favourable feedback.
CONCLUSIONS


This study demonstrated initial feasibility and acceptability of an intervention that places minimal burden on infrastructure and promotes user autonomy. This is an important advance as there is increasing recognition that the challenge of reintegration is as much a psychological and social problem as a housing problem. If effective, this style of intervention may serve as a template for future interventions with similar populations.",2020,"In the four focus groups, the intervention received very favourable feedback.
","['individuals from the broad population of homeless people and (ii', 'Seven adults with experience of homelessness (three females, four males, mean age 39\u2009years, range 18-63', 'Recruiting participants and intervention facilitators from partnering service centres', 'homeless adults', 'adults with experience of homelessness']",['Alliance Inventory-short form revised (WAI-SR'],"['recruitment and retention, cost-effectiveness and social interactions', 'Feasibility and acceptability']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0237154', 'cui_str': 'Homelessness'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0037420', 'cui_str': 'Social Interaction'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",7.0,0.0405919,"In the four focus groups, the intervention received very favourable feedback.
","[{'ForeName': 'Eva C', 'Initials': 'EC', 'LastName': 'Sundin', 'Affiliation': 'Department of Psychology, Nottingham Trent University, Nottingham, UK.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Mrowiec', 'Affiliation': 'Department of Psychology, Nottingham Trent University, Nottingham, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Bowpitt', 'Affiliation': 'Department of Psychology, Nottingham Trent University, Nottingham, UK.'}, {'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Boatman', 'Affiliation': 'Department of Psychology, Nottingham Trent University, Nottingham, UK.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Williams', 'Affiliation': 'Department of Psychology, Nottingham Trent University, Nottingham, UK.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Sarkar', 'Affiliation': 'Department of Sport and Exercise Psychology, Nottingham Trent University, Nottingham, UK.'}, {'ForeName': 'Thom S', 'Initials': 'TS', 'LastName': 'Baguley', 'Affiliation': 'Department of Psychology, Nottingham Trent University, Nottingham, UK.'}]",European journal of public health,['10.1093/eurpub/ckz202']
1336,30118241,Effects of aerobic exercise and vitamin C supplementation on rhinitis symptoms in allergic rhinitis patients.,"INTRODUCTION


Exercise training and vitamin C supplementation have both been recommended as an effective adjuvant treatment in the management of symptoms in patients with many diseases. However, its effects on rhinitis symptoms remain unclear. The aim of the present study was to determine the effects of exercise training alone, and in combination with vitamin C supplementation, on rhinitis symptoms in allergic rhinitis patients.
METHODS


Twenty-seven rhinitis patients were randomized into 3 groups: control (CON; n = 8), exercise (EX; n = 9), and exercise combined with vitamin C (EX + Vit.C; n = 10). The exercise training protocol consisted of walking and/or running on a treadmill at 65-70% heart rate reserve for 30 min per session, 3 times per week for 8 weeks. The EX + Vit.C group ingested 2,000 mg vitamin C per day.
RESULTS


After 8 weeks, both EX and EX + Vit.C groups increased peak aerobic capacity and peak nasal inspiratory flow (PNIF) and exhibited significantly decreased rhinitis symptoms, nasal blood flow (NBF) and malondialdehylde levels compared to pre-test. Rhinitis symptoms and NBF after nasal challenge with house dust mite decreased significantly in the EX and EX + Vit.C groups. The EX and EX + Vit.C groups had significantly lower nasal secretion interleukin (IL)-4, but higher nasal secretion IL-2 levels, than the CON group.
CONCLUSIONS


This study clearly confirms that aerobic exercise training significantly improved clinical of allergic rhinitis and cytokine profiles. Nonetheless, with the limited power of small sample size, whether adding vitamin C is any beneficial is not shown. A larger randomized controlled trial is thus warranted.",2018,"C groups increased peak aerobic capacity and peak nasal inspiratory flow (PNIF) and exhibited significantly decreased rhinitis symptoms, nasal blood flow (NBF) and malondialdehylde levels compared to pre-test.","['Twenty-seven rhinitis patients', 'allergic rhinitis patients', 'patients with many diseases']","['control (CON; n = 8), exercise (EX; n = 9), and exercise combined with vitamin C (EX + Vit.C', 'vitamin C', 'aerobic exercise training', 'aerobic exercise and vitamin C supplementation', 'Exercise training and vitamin C supplementation', 'EX and EX + Vit', 'exercise training alone, and in combination with vitamin C supplementation']","['rhinitis symptoms', 'clinical of allergic rhinitis and cytokine profiles', 'nasal secretion IL-2 levels', 'peak aerobic capacity and peak nasal inspiratory flow (PNIF', 'rhinitis symptoms, nasal blood flow (NBF) and malondialdehylde levels', 'Rhinitis symptoms and NBF', 'nasal secretion interleukin (IL)-4']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2607914', 'cui_str': 'Rhinitis, Allergic'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4524018', 'cui_str': 'Vitamin C supplementation'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2607914', 'cui_str': 'Rhinitis, Allergic'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0021756', 'cui_str': 'TCGF'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}]",27.0,0.0301476,"C groups increased peak aerobic capacity and peak nasal inspiratory flow (PNIF) and exhibited significantly decreased rhinitis symptoms, nasal blood flow (NBF) and malondialdehylde levels compared to pre-test.","[{'ForeName': 'Wannaporn', 'Initials': 'W', 'LastName': 'Tongtako', 'Affiliation': 'Faculty of Sports Science, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Jettanong', 'Initials': 'J', 'LastName': 'Klaewsongkram', 'Affiliation': 'Division of Allergy and Clinical Immunology, Department of Medicine, Faculty of Medicine, Allergy and Clinical Immunology Research Group, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Mickleborough', 'Affiliation': 'Department of Kinesiology, School of Public Health, Indiana University, Bloomington, Indiana, USA.'}, {'ForeName': 'Daroonwan', 'Initials': 'D', 'LastName': 'Suksom', 'Affiliation': 'Faculty of Sports Science, Chulalongkorn University, Bangkok, Thailand.'}]",Asian Pacific journal of allergy and immunology,['10.12932/AP-040417-0066']
1337,31752975,The effectiveness of an interactive organ donation education intervention for Dutch lower-educated students: a cluster randomized controlled trial.,"BACKGROUND


Organ donation registration rates remain low, especially among people with lower educational levels. An interactive educational intervention was developed to prepare lower-educated students in the Netherlands for making a well-informed decision about organ donation. This article reports on the effects of this intervention on the intention to register (i.e., the primary outcome in the study at hand) and beliefs regarding organ donation.
MATERIALS AND METHODS


The effectiveness was investigated in a post-test-only cluster randomized controlled trial, in which the intervention was offered to the experimental group and after measurement also to the control group. Randomization to the experimental and control groups took place at a class level. Teachers of schools for Intermediate Vocational Education who taught a course on Citizenship delivered three intervention elements (i.e., video fragments and discussion, quizzes with tailored feedback and exercise filling out a registration form) to their students during two 50-min lessons.
RESULTS


A total of 1170 students participated in the trial and filled out a questionnaire (45 experimental and 43 control classes). Compared to the control group, students in the experimental group had higher odds of having positive registration intentions (OR = 1.81; 95%CI [1.10-2.96]), their perceived knowledge was higher (B = 0.62; 95%CI [0.23-1.01]) and they had higher intentions to talk to family members (B = 0.68; 95%CI [0.28-1.08]) and friends (B = 0.36; 95%CI [0.07-0.66]) about organ donation. There were no effects on the choice students intended to register (OR = 1.08; 95%CI [0.67-1.73]).
CONCLUSIONS


Providing education in a classroom setting is an effective tool in increasing registration intentions. Despite uncertainties about the effects on actual registration behavior, a larger-scale dissemination of this intervention is recommended. Providing clear information and opening the discussion about organ donation is an important and promising first step towards higher registration rates.
TRIAL REGISTRATION


The Dutch Trial Register, ID: NTR6771. Registered on 24 October 2017. https://www.trialregister.nl/trial/6557.",2019,An interactive educational intervention was developed to prepare lower-educated students in the Netherlands for making a well-informed decision about organ donation.,"['Teachers of schools for Intermediate Vocational Education who taught a course on Citizenship', 'Dutch lower-educated students', 'people with lower educational levels', '1170 students participated in the trial and filled out a questionnaire (45 experimental and 43 control classes']","['interactive educational intervention', 'interactive organ donation education intervention']","['higher odds of having positive registration intentions', 'perceived knowledge']","[{'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0042933', 'cui_str': 'Vocational Education'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]","[{'cui': 'C0282366', 'cui_str': 'Organ Donation'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.136882,An interactive educational intervention was developed to prepare lower-educated students in the Netherlands for making a well-informed decision about organ donation.,"[{'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Steenaart', 'Affiliation': 'Department of Health Promotion, CAPHRI Maastricht University, PO Box 616, 6200 MD, Maastricht, The Netherlands. e.steenaart@maastrichtuniversity.nl.'}, {'ForeName': 'Rik', 'Initials': 'R', 'LastName': 'Crutzen', 'Affiliation': 'Department of Health Promotion, CAPHRI Maastricht University, PO Box 616, 6200 MD, Maastricht, The Netherlands.'}, {'ForeName': 'Math J J M', 'Initials': 'MJJM', 'LastName': 'Candel', 'Affiliation': 'Department of Methodology and Statistics, CAPHRI Maastricht University, PO Box 616, 6200 MD, Maastricht, The Netherlands.'}, {'ForeName': 'Nanne K', 'Initials': 'NK', 'LastName': 'de Vries', 'Affiliation': 'Department of Health Promotion, CAPHRI Maastricht University, PO Box 616, 6200 MD, Maastricht, The Netherlands.'}]",Trials,['10.1186/s13063-019-3882-6']
1338,30846465,Analysis of the MILES cohort reveals determinants of disease progression and treatment response in lymphangioleiomyomatosis.,"INTRODUCTION


The Multicenter International Lymphangioleiomyomatosis (LAM) Efficacy of Sirolimus (MILES) trial revealed that sirolimus stabilised lung function in patients with moderately severe LAM. The purpose of this study was to further examine the MILES cohort for the effects of racial, demographic, clinical and physiological patient characteristics on disease progression and treatment response in LAM.
METHODS


MILES subjects were stratified on the basis of menopausal status (pre-menopausal/post-menopausal), race (Asian/Caucasian), bronchodilator responsiveness (present/absent), initial forced expiratory volume in 1 s (FEV 1 ; 51-70%  versus  ≤50% predicted) and tuberous sclerosis complex (TSC) association (yes/no). A linear mixed effects model was used to compare slope differences, and nonparametric tests were used to compare medians and proportions between treatment groups in each stratum.
RESULTS


In the MILES placebo group, pre-menopausal patients declined 5-fold faster than post-menopausal patients (mean±se FEV 1  slope -17±3  versus  -3±3 mL·month -1 ; p=0.003). Upon treatment with sirolimus, both the pre-menopausal (-17±3  versus  -1±2 mL·month -1 ; p<0.0001) and post-menopausal patients (-3±3  versus  6±3 mL·month -1 ; p=0.04) exhibited a beneficial response in mean±se FEV 1  slope compared with the placebo group. Race, LAM subtype, bronchodilator responsiveness or baseline FEV 1  did not impact the rate of disease progression in the placebo group or treatment response in the sirolimus group. Menopausal status and race had differential effects on the adverse event profile of sirolimus. Baseline serum vascular endothelial growth factor (VEGF)-D >600 pg·mL -1  identified subgroups of patients who were more likely to decline on placebo and respond to treatment with sirolimus.
CONCLUSIONS


In LAM patients, treatment with sirolimus is beneficial regardless of menopausal status, race, bronchodilator responsiveness, baseline FEV 1  or TSC association. Serum VEGF-D and menopausal status can help inform therapeutic decisions.",2019,FEV 1  did not impact the rate of disease progression in the placebo group or treatment response in the sirolimus group.,"['patients with moderately severe LAM', 'MILES subjects were stratified on the basis of menopausal status (pre-menopausal/post-menopausal), race (Asian/Caucasian']","['sirolimus', 'MILES placebo', 'placebo', 'Sirolimus (MILES', 'Lymphangioleiomyomatosis (LAM']","['rate of disease progression', 'Baseline serum vascular endothelial growth factor (VEGF)-D ', 'Serum VEGF-D and menopausal status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0065041', 'cui_str': 'lipoarabinomannan'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0751674', 'cui_str': 'Lymphangioleiomyomatosis'}, {'cui': 'C0065041', 'cui_str': 'lipoarabinomannan'}]","[{'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0664390', 'cui_str': 'Vascular Endothelial Growth Factor D'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",,0.156081,FEV 1  did not impact the rate of disease progression in the placebo group or treatment response in the sirolimus group.,"[{'ForeName': 'Nishant', 'Initials': 'N', 'LastName': 'Gupta', 'Affiliation': 'University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Hye-Seung', 'Initials': 'HS', 'LastName': 'Lee', 'Affiliation': 'University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Young', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Strange', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Moss', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Lianne G', 'Initials': 'LG', 'LastName': 'Singer', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Koh', 'Initials': 'K', 'LastName': 'Nakata', 'Affiliation': 'Niigata University Medical and Dental Hospital, Niigata, Japan.'}, {'ForeName': 'Alan F', 'Initials': 'AF', 'LastName': 'Barker', 'Affiliation': 'Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Chapman', 'Affiliation': 'Cleveland Clinic, Abu Dhabi, United Arab Emirates.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Brantly', 'Affiliation': 'University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Stocks', 'Affiliation': 'University of Texas Health Sciences Center, Tyler, TX, USA.'}, {'ForeName': 'Kevin K', 'Initials': 'KK', 'LastName': 'Brown', 'Affiliation': 'National Jewish Health and the University of Colorado, Denver, CO, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Lynch', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Hilary J', 'Initials': 'HJ', 'LastName': 'Goldberg', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Downey', 'Affiliation': 'National Jewish Health and the University of Colorado, Denver, CO, USA.'}, {'ForeName': 'Angelo M', 'Initials': 'AM', 'LastName': 'Taveira-DaSilva', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Krischer', 'Affiliation': 'University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Setchell', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Bruce C', 'Initials': 'BC', 'LastName': 'Trapnell', 'Affiliation': 'University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka, Japan.'}, {'ForeName': 'Francis X', 'Initials': 'FX', 'LastName': 'McCormack', 'Affiliation': 'University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The European respiratory journal,['10.1183/13993003.02066-2018']
1339,30932133,The Effect of Branched Chain Amino Acids-Enriched Nutritional Supplements on Activities of Daily Living and Muscle Mass in Inpatients with Gait Impairments: A Randomized Controlled Trial.,"OBJECTIVE


To investigate the effects of continuous intervention with branched chain amino acids-enriched nutritional supplements from the acute phase to convalescent rehabilitation wards in inpatients with gait impairments.
DESIGN


Open-label, randomized, parallel-group comparison study (UMIN Clinical Trials Registry ID: UMIN000018640).
SETTING


Acute care and convalescent rehabilitation wards.
PARTICIPANTS


We studied 80 patients undergoing stand/gait training.
INTERVENTIONS


Participants in the intervention group (RJ group) received nutritional supplements (jelly foods comprising 2500 mg BCAA and 20 IU vitamin D) twice a day until hospital discharge.
MEASUREMENTS


The primary outcome was the motor components of the Functional Independence Measure (FIM-m), and the secondary outcome was skeletal muscle mass index.
RESULTS


Analyses were conducted on 55 patients who were able to perform stand/gait training continuously from the acute until the recovery phases. FIM-m was significantly elevated in the RJ group and the control group , but no difference was noted between the two groups. Only the RJ group showed a significant increase in skeletal muscle mass index, and the amount of variation was significantly different between the two groups (the control group decreased an average of 2.2% and the RJ group increased an average of 4.3%; P = 0.014). A significant decrease in body weight was found only in the control group (P = 0.084).
CONCLUSIONS


Nutritional interventions using branched chain amino acids (BCAA)-enriched nutritional supplements demonstrated no significant difference in activities of daily living; however, an increase in skeletal muscle mass was noted. Skeletal muscle mass and body weight differed significantly between the two groups, and BCAA-enriched nutritional supplements intake in acute and convalescent rehabilitation wards may be effective for the prevention of malnutrition and sarcopenia.",2019,"FIM-m was significantly elevated in the RJ group and the control group , but no difference was noted between the two groups.","['80 patients undergoing stand/gait training', 'Inpatients with Gait Impairments', 'Acute care and convalescent rehabilitation wards', '55 patients who were able to perform stand/gait training continuously from the acute until the recovery phases', 'inpatients with gait impairments']","['Branched Chain Amino Acids-Enriched Nutritional Supplements', 'RJ', 'continuous intervention with branched chain amino acids-enriched nutritional supplements', 'nutritional supplements (jelly foods comprising 2500 mg BCAA and 20 IU vitamin D']","['skeletal muscle mass', 'skeletal muscle mass index', 'FIM-m', 'Skeletal muscle mass and body weight', 'amount of variation', 'motor components of the Functional Independence Measure (FIM-m), and the secondary outcome was skeletal muscle mass index', 'activities of daily living', 'body weight', 'Activities of Daily Living and Muscle Mass']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure (procedure)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0453543', 'cui_str': 'Jello'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C4319601', 'cui_str': '2500 (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]","[{'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure (assessment scale)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}]",80.0,0.0975411,"FIM-m was significantly elevated in the RJ group and the control group , but no difference was noted between the two groups.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Moriwaki', 'Affiliation': 'Misa Moriwaki MD, Department of Rehabilitation Medicine, Midorigaoka Hospital, 3-13-1 Makami-cho, Takatsuki, Osaka, Japan 569-1121, Tel.: +81-72-681-5717, Fax: +81-72-681-5796, E-mail: hanamizuki.rehab@gmail.com.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wakabayashi', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Sakata', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Domen', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-019-1172-3']
1340,30932134,Regulation of Amino Acid Transporters and Sensors in Response to a High protein Diet: A Randomized Controlled Trial in Elderly Men.,"BACKGROUND


The mammalian target of rapamycin complex 1 (mTORC1) is fundamental for many cellular processes, yet it is often dysregulated with aging. Increased amino acid (AA) availability is correlated with the expression of AA transporters (AAT) and mTORC1 activity. Although many AA sensors and mediators have been proposed to relay the AA signal to mTORC1, it has not yet been determined if chronic dietary intervention affects the expression of AAT, sensors and mediators and their relationships with mTORC1 activity.
OBJECTIVE AND DESIGN


This study investigated whether the consumption of a diet containing either the current recommended daily allowance (RDA) of protein intake (0.8 g/kg/d) or twice the RDA (2RDA) for ten weeks affected the expression of targets associated with AA transport, sensing and mTORC1 regulation in 26 older men (70-81 years).
METHOD


Muscle biopsies were collected before and after the intervention under fasting conditions. Diets were controlled by providing fully prepared meals and snacks. Western blot and quantitative polymerase chain reaction were used to measure protein and gene expression respectively.
RESULTS


Consumption of 2RDA reduced the protein expression of L-type amino acid transporter 1 (LAT1). However, plasma leucine concentration and basal mTORC1 activity were unaltered. The downregulation of LAT1 did not affect the expression of AA sensors and mediators, including leucyl tRNA synthetase (LRS), cytosolic arginine sensor for mTORC1 (CASTOR1), Sestrin2 and Rag proteins. Instead, total ribosomal protein S6 (RPS6) was upregulated with 2RDA.
CONCLUSION


Ten weeks of 2RDA diet did not affect the fasting mTORC1 signaling, but increased total RPS6 might suggest improved muscular translational capacity to maintain muscular mass.",2019,"The downregulation of LAT1 did not affect the expression of AA sensors and mediators, including leucyl tRNA synthetase (LRS), cytosolic arginine sensor for mTORC1 (CASTOR1), Sestrin2 and Rag proteins.","['26 older men (70-81 years', 'Elderly Men']",['diet containing either the current recommended daily allowance (RDA) of protein intake (0.8 g/kg/d) or twice the RDA (2RDA'],"['total ribosomal protein S6 (RPS6', 'expression of AA sensors and mediators, including leucyl tRNA synthetase (LRS), cytosolic arginine sensor for mTORC1 (CASTOR1), Sestrin2 and Rag proteins', 'Increased amino acid (AA) availability', 'plasma leucine concentration and basal mTORC1 activity', 'protein expression of L-type amino acid transporter 1 (LAT1', 'fasting mTORC1 signaling']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0524337', 'cui_str': 'Elderly man (person)'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0524786', 'cui_str': 'Recommended Daily Allowances'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C1720725', 'cui_str': 'Twice'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0073336', 'cui_str': 'Ribosomal Protein S6'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0023414', 'cui_str': 'Leucine-tRNA Synthetase'}, {'cui': 'C0968133', 'cui_str': 'alpha-(trifluoromethyl)arginine'}, {'cui': 'C3888046', 'cui_str': 'mTORC1 Complex'}, {'cui': 'C0380301', 'cui_str': 'LERK-7 Protein'}, {'cui': 'C1291157', 'cui_str': 'Increased amino acid'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0949771', 'cui_str': 'Amino Acid Transporter'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]",,0.0337827,"The downregulation of LAT1 did not affect the expression of AA sensors and mediators, including leucyl tRNA synthetase (LRS), cytosolic arginine sensor for mTORC1 (CASTOR1), Sestrin2 and Rag proteins.","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Zeng', 'Affiliation': 'Dr. Cameron Mitchell Faculty of Education | School of Kinesiology, The University of British Columbia | Vancouver Campus, 2553 Wesbrook Mall | Vancouver British Columbia | V6T 1Z3 Canada, Phone 604 827 2072| Cell 604 790 3815, cameron.mitchell@ubc.ca.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Prodhan', 'Affiliation': ''}, {'ForeName': 'R F', 'Initials': 'RF', 'LastName': ""D'Souza"", 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ramzan', 'Affiliation': ''}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Mitchell', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': ''}, {'ForeName': 'S O', 'Initials': 'SO', 'LastName': 'Knowles', 'Affiliation': ''}, {'ForeName': 'N C', 'Initials': 'NC', 'LastName': 'Roy', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sjödin', 'Affiliation': ''}, {'ForeName': 'K-H', 'Initials': 'KH', 'LastName': 'Wagner', 'Affiliation': ''}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Milan', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Cameron-Smith', 'Affiliation': ''}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Mitchell', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-019-1171-4']
1341,30948276,"Gene-expression profiling of bortezomib added to standard chemoimmunotherapy for diffuse large B-cell lymphoma (REMoDL-B): an open-label, randomised, phase 3 trial.","BACKGROUND


Biologically distinct subtypes of diffuse large B-cell lymphoma can be identified using gene-expression analysis to determine their cell of origin, corresponding to germinal centre or activated B cell. We aimed to investigate whether adding bortezomib to standard therapy could improve outcomes in patients with these subtypes.
METHODS


In a randomised evaluation of molecular guided therapy for diffuse large B-cell lymphoma with bortezomib (REMoDL-B), an open-label, adaptive, randomised controlled, phase 3 superiority trial, participants were recruited from 107 cancer centres in the UK (n=94) and Switzerland (n=13). Eligible patients had previously untreated, histologically confirmed diffuse large B-cell lymphoma with sufficient diagnostic material from initial biopsies for gene-expression profiling and pathology review; were aged 18 years or older; had ECOG performance status of 2 or less; had bulky stage I or stage II-IV disease requiring full-course chemotherapy; had measurable disease; and had cardiac, lung, renal, and liver function sufficient to tolerate chemotherapy. Patients initially received one 21-day cycle of standard rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP; rituximab 375 mg/m 2 , cyclophosphamide 750 mg/m 2 , doxorubicin 50 mg/m 2 , and vincristine 1·4 mg/m 2  [to a maximum of 2 mg total dose] intravenously on day 1 of the cycle, and prednisolone 100 mg orally once daily on days 1-5). During this time, we did gene-expression profiling using whole genome cDNA-mediated annealing, selection, extension, and ligation assay of tissue from routine diagnostic biopsy samples to determine the cell-of-origin subtype of each participant (germinal centre B cell, activated B cell, or unclassified). Patients were then centrally randomly assigned (1:1) via a web-based system, with block randomisation stratified by international prognostic index score and cell-of-origin subtype, to continue R-CHOP alone (R-CHOP group; control), or with bortezomib (RB-CHOP group; experimental; 1·3 mg/m 2  intravenously or 1·6 mg/m 2  subcutaneously) on days 1 and 8 for cycles two to six. If RNA extracted from the diagnostic tissues was of insufficient quality or quantity, participants were given R-CHOP as per the control group. The primary endpoint was 30-month progression-free survival, for the germinal centre and activated B-cell population. The primary analysis was on the modified intention-to-treat population of activated and germinal centre B-cell population. Safety was assessed in all participants who were given at least one dose of study drug. We report the progression-free survival and safety outcomes for patients in the follow-up phase after the required number of events occurred. This study was registered at ClinicalTrials.gov, number NCT01324596, and recruitment and treatment has completed for all participants, with long-term follow-up ongoing.
FINDINGS


Between June 2, 2011, and June 10, 2015, 1128 eligible patients were registered, of whom 918 (81%) were randomly assigned to receive treatment (n=459 to R-CHOP, n=459 to RB-CHOP), comprising 244 (26·6%) with activated B-cell disease, 475 (51·7%) with germinal centre B cell disease, and 199 (21·7%) with unclassified disease. At a median follow-up of 29·7 months (95% CI 29·0-32·0), we saw no evidence for a difference in progression-free survival in the combined germinal centre and activated B-cell population between R-CHOP and RB-CHOP (30-month progression-free survival 70·1%, 95% CI 65·0-74·7 vs 74·3%, 69·3-78·7; hazard ratio 0·86, 95% CI 0·65-1·13; p=0·28). The most common grade 3 or worse adverse event was haematological toxicity, reported in 178 (39·8%) of 447 patients given R-CHOP and 187 (42·1%) of 444 given RB-CHOP. However, RB-CHOP was not associated with increased haematological toxicity and 398 [87·1%] of 459 participants assigned to receive RB-CHOP completed six cycles of treatment. Grade 3 or worse neuropathy occurred in 17 (3·8%) patients given RB-CHOP versus eight (1·8%) given R-CHOP. Serious adverse events occurred in 190 (42·5%) patients given R-CHOP, including five treatment-related deaths, and 223 (50·2%) given RB-CHOP, including four treatment-related deaths.
INTERPRETATION


This is the first large-scale study in diffuse large B-cell lymphoma to use real-time molecular characterisation for prospective stratification, randomisation, and subsequent analysis of biologically distinct subgroups of patients. The addition of bortezomib did not improve progression-free survival.
FUNDING


Janssen-Cilag, Bloodwise, and Cancer Research UK.",2019,"The primary endpoint was 30-month progression-free survival, for the germinal centre and activated B-cell population.","['patients with these subtypes', 'diffuse large B-cell lymphoma with', 'Eligible patients had previously untreated, histologically confirmed diffuse large B-cell lymphoma with sufficient diagnostic material from initial biopsies for gene-expression profiling and pathology review; were aged 18 years or older; had ECOG performance status of 2 or less; had bulky stage', 'Between June 2, 2011, and June 10, 2015, 1128 eligible patients were registered, of whom 918 (81', 'all participants, with long-term follow-up ongoing', 'participants were recruited from 107 cancer centres in the UK (n=94) and Switzerland (n=13', 'participants who were given at least one dose of study drug']","['bortezomib (REMoDL-B', 'standard chemoimmunotherapy', 'continue R-CHOP alone (R-CHOP group; control), or with bortezomib (RB-CHOP group; experimental; 1·3 mg/m 2  intravenously or 1·6', 'bortezomib', 'standard rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP; rituximab 375 mg/m 2 , cyclophosphamide 750 mg/m 2 , doxorubicin 50 mg/m 2 , and vincristine 1·4', 'prednisolone', 'molecular guided therapy']","['progression-free survival and safety outcomes', 'Grade 3 or worse neuropathy', 'progression-free survival', 'measurable disease; and had cardiac, lung, renal, and liver function sufficient to tolerate chemotherapy', '30-month progression-free survival, for the germinal centre and activated B-cell population', 'haematological toxicity', 'Serious adverse events', 'Safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C0079744', 'cui_str': 'Diffuse Large-Cell Lymphoma'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0205410', 'cui_str': 'Sufficient (qualifier value)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0752248', 'cui_str': 'Gene Expression Monitoring'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C4517745', 'cui_str': '375 (qualifier value)'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0205410', 'cui_str': 'Sufficient (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1128.0,0.275044,"The primary endpoint was 30-month progression-free survival, for the germinal centre and activated B-cell population.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Davies', 'Affiliation': 'Cancer Research UK Centre, University of Southampton, Southampton, UK; Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Cummin', 'Affiliation': 'Cancer Research UK Centre, University of Southampton, Southampton, UK; Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Barrans', 'Affiliation': 'Haematological Malignancy Diagnostic Service, Leeds Cancer Centre, Leeds Teaching Hospitals, Leeds, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Maishman', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Mamot', 'Affiliation': 'Medical Oncology, Cantonal Hospital Aarau, Switzerland.'}, {'ForeName': 'Urban', 'Initials': 'U', 'LastName': 'Novak', 'Affiliation': 'Department of Medical Oncology, Inselspital, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Caddy', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Stanton', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Shamim', 'Initials': 'S', 'LastName': 'Kazmi-Stokes', 'Affiliation': 'Centre for Drug Development, Cancer Research UK, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McMillan', 'Affiliation': 'Department of Haematology, Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Fields', 'Affiliation': ""Department of Haematology, Guy's and St Thomas' Hospitals NHS Trust, Kings Health Partners, London, UK.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Pocock', 'Affiliation': 'Department of Haematology, East Kent Hospitals University Foundation Trust, Canterbury, UK.'}, {'ForeName': 'Graham P', 'Initials': 'GP', 'LastName': 'Collins', 'Affiliation': 'Oxford Cancer and Haematology Centre, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Stephens', 'Affiliation': 'National Cancer Research Institute Consumer Forum, London, UK.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cucco', 'Affiliation': 'Department of Pathology, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Clipson', 'Affiliation': 'Department of Pathology, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Chulin', 'Initials': 'C', 'LastName': 'Sha', 'Affiliation': 'School of Molecular and Cellular Biology, Faculty of Biological Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Reuben', 'Initials': 'R', 'LastName': 'Tooze', 'Affiliation': 'Haematological Malignancy Diagnostic Service, Leeds Cancer Centre, Leeds Teaching Hospitals, Leeds, UK; Section of Experimental Haematology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Care', 'Affiliation': 'Section of Experimental Haematology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Griffiths', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Ming-Qing', 'Initials': 'MQ', 'LastName': 'Du', 'Affiliation': 'Department of Pathology, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Westhead', 'Affiliation': 'School of Molecular and Cellular Biology, Faculty of Biological Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Burton', 'Affiliation': 'Haematological Malignancy Diagnostic Service, Leeds Cancer Centre, Leeds Teaching Hospitals, Leeds, UK.'}, {'ForeName': 'Peter W M', 'Initials': 'PWM', 'LastName': 'Johnson', 'Affiliation': 'Cancer Research UK Centre, University of Southampton, Southampton, UK. Electronic address: johnsonp@soton.ac.uk.'}]",The Lancet. Oncology,['10.1016/S1470-2045(18)30935-5']
1342,30947936,Everolimus-Eluting Versus Biolimus-Eluting Stents With Biodegradable Polymers in Unselected Patients Undergoing Percutaneous Coronary Intervention: A Randomized Noninferiority Trial With 1-Year Follow-Up (SORT OUT VIII Trial).,"OBJECTIVES


The aim of this study was to compare the thin-strut biodegradable-polymer everolimus-eluting platinum-chromium stent (EES) with the biodegradable-polymer biolimus-eluting stainless-steel stent (BES).
BACKGROUND


Currently available drug-eluting coronary stents have been refined to reduce the risk for coronary events following implantation.
METHODS


This randomized, multicenter, all-comers, noninferiority trial was undertaken at 3 sites in western Denmark. Patients with clinical indications for percutaneous coronary intervention were eligible for inclusion. Patients were randomly assigned (1:1) to either EES or BES. The primary endpoint, target lesion failure, was a composite of safety (cardiac death and myocardial infarction not clearly attributable to a nontarget lesion) and efficacy (target lesion revascularization) at 12 months, analyzed using intention-to-treat principles. The trial was powered to assess target lesion failure noninferiority of the EES compared with the BES with a predetermined noninferiority margin of 3%.
RESULTS


A total of 1,385 patients were assigned to treatment with EES and 1,369 patients to treatment with BES. The analysis showed that 55 patients (4.0%) assigned to the EES and 60 (4.4%) assigned to the BES met the primary endpoint (absolute risk difference 0.4%; upper limit of 1-sided 95% confidence interval: 1.7%; p < 0.001).
CONCLUSIONS


At 1-year follow-up, the EES was found to be noninferior to the BES with respect to target lesion failure. (Everolimus-eluting SYNERGY Stent Versus Biolimus-Eluting Biomatrix NeoFlex Stent-SORT-OUT VIII; NCT02093845).",2019,"At 1-year follow-up, the EES was found to be noninferior to the BES with respect to target lesion failure.","['3 sites in western Denmark', 'Patients with clinical indications for percutaneous coronary intervention were eligible for inclusion', '1,385 patients', 'Unselected\xa0Patients']","['EES', 'Percutaneous Coronary Intervention', 'Everolimus-eluting SYNERGY Stent', 'Everolimus-Eluting Versus Biolimus-Eluting Stents', 'BES', 'thin-strut biodegradable-polymer everolimus-eluting platinum-chromium stent (EES) with the biodegradable-polymer biolimus-eluting stainless-steel stent (BES', 'EES or BES']","['target lesion failure', 'composite\xa0of safety (cardiac death and myocardial infarction not clearly attributable to a nontarget lesion) and efficacy (target lesion revascularization']","[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0053353', 'cui_str': 'N,N-bis(2-hydroxyethyl)aminoethanesulfonic acid'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0441295', 'cui_str': 'Strut (physical object)'}, {'cui': 'C0032521', 'cui_str': 'Polymers'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0168430', 'cui_str': 'chromium hexavalent ion'}, {'cui': 'C0038126', 'cui_str': 'Stainless Steel'}]","[{'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]",1385.0,0.168705,"At 1-year follow-up, the EES was found to be noninferior to the BES with respect to target lesion failure.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Maeng', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark. Electronic address: michael.maeng@ki.au.dk.'}, {'ForeName': 'Evald Høj', 'Initials': 'EH', 'LastName': 'Christiansen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.'}, {'ForeName': 'Bent', 'Initials': 'B', 'LastName': 'Raungaard', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Kahlert', 'Affiliation': 'Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Christian Juhl', 'Initials': 'CJ', 'LastName': 'Terkelsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.'}, {'ForeName': 'Steen Dalby', 'Initials': 'SD', 'LastName': 'Kristensen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.'}, {'ForeName': 'Steen', 'Initials': 'S', 'LastName': 'Carstensen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Aarøe', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Svend Eggert', 'Initials': 'SE', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Anton Boel', 'Initials': 'AB', 'LastName': 'Villadsen', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Jens Flensted', 'Initials': 'JF', 'LastName': 'Lassen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.'}, {'ForeName': 'Troels', 'Initials': 'T', 'LastName': 'Thim', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.'}, {'ForeName': 'Ashkan', 'Initials': 'A', 'LastName': 'Eftekhari', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.'}, {'ForeName': 'Karsten Tange', 'Initials': 'KT', 'LastName': 'Veien', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Knud Nørregaard', 'Initials': 'KN', 'LastName': 'Hansen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Junker', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Hans Erik', 'Initials': 'HE', 'LastName': 'Bøtker', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.'}, {'ForeName': 'Lisette Okkels', 'Initials': 'LO', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2018.12.036']
1343,30947938,7-Year Outcomes of a Randomized Trial Comparing the First-Generation Sirolimus-Eluting Stent Versus the New-Generation Everolimus-Eluting Stent: The RESET Trial.,"OBJECTIVES


The aim of this study was to compare 7-year outcomes between the first-generation sirolimus-eluting stent (SES) and the new-generation everolimus-eluting stent (EES) in a randomized clinical trial.
BACKGROUND


There is a scarcity of very long-term (beyond 5 years) data from clinical trials investigating whether new-generation drug-eluting stents have clear clinical advantages over first-generation drug-eluting stents.
METHODS


RESET (Randomized Evaluation of Sirolimus-Eluting Versus Everolimus-Eluting Stent Trial) is the largest randomized trial comparing EES with SES (NCT01035450). Among a total of 3,197 patients in the original RESET population from 100 centers, the present extended 7-year follow-up study was conducted in 2,667 patients from 75 centers after excluding those patients enrolled from centers that denied participation. Complete 7-year follow-up was achieved in 91.5% of patients.
RESULTS


The cumulative 7-year incidence of the primary efficacy endpoint of target lesion revascularization was not significantly different between EES and SES (10.2% vs. 11.7%; hazard ratio: 0.87; 95% confidence interval: 0.68 to 1.10; p = 0.24). The risk for the primary safety endpoint of death or myocardial infarction trended lower with EES than with SES (20.6% vs. 23.6%; hazard ratio: 0.85; 95% confidence interval: 0.72 to 1.005; p = 0.06). The cumulative 7-year incidence of definite stent thrombosis was very low and similar between EES and SES (0.9% vs. 1.0%; p = 0.82). The lower risk of EES relative to SES was significant for the composite secondary endpoint of target lesion failure (13.3% vs. 18.1%; hazard ratio: 0.72; 95% confidence interval: 0.59 to 0.88; p = 0.001).
CONCLUSIONS


During 7 years of follow-up, the risk for target lesion revascularization was not significantly different between the new-generation EES and the first-generation SES.",2019,The cumulative 7-year incidence of the primary efficacy endpoint of target lesion revascularization was not significantly different between EES and SES (10.2% vs. 11.7%; hazard ratio: 0.87; 95% confidence interval: 0.68 to 1.10; p = 0.24).,"['3,197 patients in the original RESET population from 100 centers, the present extended 7-year follow-up study was conducted in 2,667 patients from 75\xa0centers after excluding those patients enrolled from centers that denied participation']","['Sirolimus-Eluting Stent Versus the New-Generation Everolimus-Eluting Stent', 'EES', 'sirolimus-eluting stent (SES) and the new-generation everolimus-eluting stent (EES', 'Sirolimus-Eluting Versus Everolimus-Eluting Stent Trial']","['cumulative 7-year incidence of definite stent thrombosis', 'death or myocardial infarction', 'risk for target lesion revascularization', 'cumulative 7-year incidence of the primary efficacy endpoint of target lesion revascularization', 'lower risk of EES relative to SES', 'target lesion failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0332319', 'cui_str': 'Denied (qualifier value)'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",3197.0,0.297786,The cumulative 7-year incidence of the primary efficacy endpoint of target lesion revascularization was not significantly different between EES and SES (10.2% vs. 11.7%; hazard ratio: 0.87; 95% confidence interval: 0.68 to 1.10; p = 0.24).,"[{'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Shiomi', 'Affiliation': 'Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kozuma', 'Affiliation': 'Division of Cardiology, Teikyo University Hospital, Tokyo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Morimoto', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Kazushige', 'Initials': 'K', 'LastName': 'Kadota', 'Affiliation': 'Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Tanabe', 'Affiliation': 'Division of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Morino', 'Affiliation': 'Division of Cardiology, Iwate Medical University Hospital, Morioka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Akasaka', 'Affiliation': 'Department of Cardiovascular Medicine, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Mitsuru', 'Initials': 'M', 'LastName': 'Abe', 'Affiliation': 'Division of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Takeji', 'Affiliation': 'Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Suwa', 'Affiliation': 'Division of Cardiology, Juntendo University Shizuoka Hospital, Izonokuni, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Ito', 'Affiliation': 'Division of Cardiology, Saiseikai Yokohama City Eastern Hospital, Yokohama, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Kobayashi', 'Affiliation': 'Division of Cardiology, Hamamatsu Medical Center, Hamamatsu, Japan.'}, {'ForeName': 'Kazuoki', 'Initials': 'K', 'LastName': 'Dai', 'Affiliation': 'Division of Cardiology, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Nakao', 'Affiliation': 'Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Tarutani', 'Affiliation': 'Division of Cardiology, Okamura Memorial Hospital, Shimizu, Japan.'}, {'ForeName': 'Ryoji', 'Initials': 'R', 'LastName': 'Taniguchi', 'Affiliation': 'Division of Cardiology, Hyogo Prefectural Amagasaki General Medical Center, Amagasaki, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Nishikawa', 'Affiliation': 'Division of Cardiology, Mie Heart Center, Mie, Japan.'}, {'ForeName': 'Yoshito', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': 'Division of Cardiology, Iwaki Kyoritsu General Hospital, Iwaki, Japan.'}, {'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Nakagawa', 'Affiliation': 'Division of Cardiology, Tenri Hospital, Tenri, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ando', 'Affiliation': 'Division of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Division of Cardiology, Toyota Memorial Hospital, Toyota, Japan.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Kawai', 'Affiliation': 'Division of Cardiology, Chikamori Hospital, Kochi, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Hibi', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan. Electronic address: taketaka@kuhp.kyoto-u.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.01.234']
1344,30950970,COMPARISON OF INTRAVITREAL DEXAMETHASONE IMPLANT AND AFLIBERCEPT IN PATIENTS WITH TREATMENT-NAIVE DIABETIC MACULAR EDEMA WITH SEROUS RETINAL DETACHMENT.,"PURPOSE


To compare the efficacy and safety of intravitreal dexamethasone (DEX) implant versus aflibercept in patients with treatment-naive diabetic macular edema with inflammatory biomarkers.
METHODS


Ninety-eight eyes of 62 treatment-naive patients with diabetic macular edema with serous retinal detachment and hyperreflective foci were enrolled. Each patient was randomized to receive either aflibercept or DEX implant treatment. The treatment protocol included 3 monthly injections of 2 mg of aflibercept as a loading phase in the anti-vascular endothelial growth factor group and 0.7 mg of DEX implant in the DEX group and then pro re nata treatment. Primary outcome measures were mean changes in visual acuity and central retinal thickness at the end of the 12-month follow-up.
RESULTS


Forty-eight eyes of 29 patients were received DEX implant, and 50 eyes of 33 patients received the aflibercept injection. Mean central retinal thickness decreased from 615.2 µm at baseline to 297.7 µm at 12 months in the DEX group (P < 0.001) and from 576.5 µm to 367.4 µm in the aflibercept group (P < 0.001). Except for the first month, mean central retinal thickness reduction was significantly higher in the DEX group (P < 0.05, Mann-Whitney U Test). Visual acuity improved significantly at the end of the follow-ups (46.3-52.7 Early Treatment Diabetic Retinopathy Study letters in the DEX group and 47.5-56.8 Early Treatment Diabetic Retinopathy Study letters in the aflibercept group at 12 months, P < 0.001, paired-sample t-test). Adjusting by baseline values, the increase in mean visual acuity during the 12-month follow-ups favored the aflibercept group (P < 0.01), 25% of the DEX-treated eyes and 42% of the aflibercept treated eyes experienced 10 or more Early Treatment Diabetic Retinopathy Study letters visual gain (P: 0.058). The DEX group received significantly fewer (2.6 vs. 7.2) injections (P: 0.001).
CONCLUSION


It was observed that the both of DEX implant and aflibercept were effective and safe in treatment-naive diabetic macular edema patients with inflammatory phenotype. Anatomical results were found to be better in the DEX group, and functional results were found to be better in the aflibercept group. In pseudophakic eyes, the functional superiority of aflibercept ceased to exist, and the low number of injections in the DEX implant group was seen as an advantage.",2020,"Except for the first month, mean central retinal thickness reduction was significantly higher in the DEX group (P < 0.05, Mann-Whitney U Test).","['diabetic macular edema patients with inflammatory phenotype', 'Ninety-eight eyes of 62 treatment-naive patients with diabetic macular edema with serous retinal detachment and hyperreflective foci were enrolled', 'patients with treatment-naive diabetic macular edema with inflammatory biomarkers', 'WITH TREATMENT-NAIVE DIABETIC MACULAR EDEMA WITH SEROUS RETINAL DETACHMENT', 'Forty-eight eyes of 29 patients']","['intravitreal dexamethasone (DEX) implant versus aflibercept', 'DEX', 'aflibercept injection', 'aflibercept or DEX', 'aflibercept', 'DEX implant', 'DEX implant and aflibercept']","['Early Treatment Diabetic Retinopathy Study letters visual gain', 'mean visual acuity', 'Mean central retinal thickness', 'Visual acuity', 'mean changes in visual acuity and central retinal thickness at the end of the 12-month follow-up', 'efficacy and safety', 'mean central retinal thickness reduction']","[{'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C4319627', 'cui_str': 'Ninety-eight'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0154822', 'cui_str': 'Exudative retinal detachment'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",29.0,0.0251242,"Except for the first month, mean central retinal thickness reduction was significantly higher in the DEX group (P < 0.05, Mann-Whitney U Test).","[{'ForeName': 'Cemal', 'Initials': 'C', 'LastName': 'Ozsaygili', 'Affiliation': 'Kayseri City Hospital, Kocasinan, Kayseri, Turkey.'}, {'ForeName': 'Necati', 'Initials': 'N', 'LastName': 'Duru', 'Affiliation': ''}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002537']
1345,31704549,Health-related quality of life in patients with fully resected BRAF V600  mutation-positive melanoma receiving adjuvant vemurafenib.,"AIM OF STUDY


The aim of the study was to assess the impact of treatment with adjuvant vemurafenib monotherapy on health-related quality of life (HRQOL) in patients with resected stage IIC-IIIC melanoma.
METHODS


The phase 3 BRIM8 study (NCT01667419) randomised patients with BRAF V600  mutation-positive resected stage IIC-IIIC melanoma to 960 mg of vemurafenib twice daily or matching placebo for 52 weeks (13 × 28-day cycles). Patients completed the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3 at baseline, cycle 1 (days 1, 15 and 22), cycle 2 (days 1 and 15), day 1 of every subsequent 4-week cycle, the end-of-treatment visit and each visit during the follow-up period.
RESULTS


Completion rates for the EORTC QLQ-C30 questionnaire were high (>80%). There was a mean decline in the global health status (GHS)/quality of life (QOL) score of 17.4 (±22.9) and 17.3 (±24.1) points at days 15 and 22 of cycle 1, respectively, among vemurafenib-treated patients who recovered to approximately 10 points below baseline for the remainder of the treatment period. A similar trend was observed in all functional scales except for cognitive function (<10-point change from baseline at all visits) and in the symptom scores for appetite loss, fatigue and pain. As observed for the GHS/QOL score, all scores rapidly returned to baseline after completion of planned vemurafenib treatment or treatment discontinuation.
CONCLUSIONS


The schedule of HRQOL assessments allowed for an accurate and complete evaluation of the impact of acute treatment-related symptoms. Vemurafenib-treated patients experience clinically meaningful moderate worsening in some treatment- or disease-related symptoms and GHS/QOL that resolve over time.",2019,"A similar trend was observed in all functional scales except for cognitive function (<10-point change from baseline at all visits) and in the symptom scores for appetite loss, fatigue and pain.","['patients with resected stage IIC-IIIC melanoma', 'patients with BRAF V600  mutation-positive resected stage IIC-IIIC melanoma to 960\xa0mg of', 'patients with fully resected BRAF V600  mutation-positive melanoma receiving adjuvant']","['adjuvant vemurafenib monotherapy', 'vemurafenib', 'Vemurafenib', 'vemurafenib twice daily or matching placebo']","['appetite loss, fatigue and pain', 'Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version', 'cognitive function', 'global health status (GHS)/quality of life (QOL) score', 'GHS/QOL score', 'health-related quality of life (HRQOL', 'EORTC QLQ-C30 questionnaire', 'Health-related quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457161', 'cui_str': 'Stage IIc'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4517908', 'cui_str': '960 (qualifier value)'}]","[{'cui': 'C3192263', 'cui_str': 'Vemurafenib'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",,0.376995,"A similar trend was observed in all functional scales except for cognitive function (<10-point change from baseline at all visits) and in the symptom scores for appetite loss, fatigue and pain.","[{'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Hufelandstr. 55, 45122, Essen, Germany; The German Cancer Consortium, Heidelberg, Germany. Electronic address: dirk.schadendorf@uk-essen.de.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Di Giacomo', 'Affiliation': 'Division of Medical Oncology and Immunotherapy, Center for Immuno-Oncology, University Hospital of Siena, Banchi di Sotto, 55, 53100, Siena, SI, Italy.'}, {'ForeName': 'Lev', 'Initials': 'L', 'LastName': 'Demidov', 'Affiliation': 'N. N. Blokhin Russian Cancer Research Center, Ministry of Health, Russian Academy of Medical Sciences, Kashirskoye Shosse 24, 115478, Moscow, Russian Federation.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Merelli', 'Affiliation': 'Department of Oncology and Haematology, Papa Giovanni XXIII Cancer Center Hospital, Centro Ospedaliero, 24129, Bergamo, BG, Italy.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Bondarenko', 'Affiliation': 'Dnipropetrovsk State Medical Academy, Volodymyra Vernadskoho St, 9, Dnipropetrovsk, 49044, Ukraine.'}, {'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Melanoma Unit, Cancer Immunotherapy and Development Therapeutics, Istituto Nazionale Tumori, IRCCS Fondazione Pascale, Via Mariano Semmola, 53, 80131, Napoli, NA, Italy.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Herbert', 'Affiliation': 'Bristol Haematology and Oncology Centre, Horfield Rd, Avon, Bristol, BS2 8ED, United Kingdom.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Mackiewicz', 'Affiliation': 'Department of Cancer Immunology, Poznan University for Medical Sciences, Med-POLONIA, Collegium Maius, Fredry 10, 61-701, Poznań, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie Institute - Oncology Center, Wawelska 15 B, 00-001, Warsaw, Poland.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Guminski', 'Affiliation': 'Melanoma Translational Research Group, Melanoma Institute Australia, 40 Rocklands Rd, Wollstonecraft NSW, 2065, New South Wales, Australia.'}, {'ForeName': 'Grant R', 'Initials': 'GR', 'LastName': 'Goodman', 'Affiliation': 'Genentech, Inc., 410 Allerton Ave, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Simmons', 'Affiliation': 'Genentech, Inc., 410 Allerton Ave, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Chenglin', 'Initials': 'C', 'LastName': 'Ye', 'Affiliation': 'Genentech, Inc., 410 Allerton Ave, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Hong', 'Affiliation': 'Genentech, Inc., 410 Allerton Ave, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Lewis', 'Affiliation': 'University of Colorado Comprehensive Cancer Center, 1665 Aurora Court Anschutz Cancer Pavilion, Aurora, CO 80045, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.09.019']
1346,30936043,Training gains and transfer effects after mnemonic strategy training in mild cognitive impairment: A fMRI study.,"Prior work has revealed that mnemonic strategy training (MST) can enhance memory for specific content and engages regions in the frontoparietal cognitive control network. Evidence of transfer to novel content is less clear. Here, we provide secondary analysis of functional magnetic resonance imaging (fMRI) data acquired during a randomized controlled trial that compared MST to an active education control condition in patients with amnestic mild cognitive impairment (a-MCI). In the trial, thirty participants with a-MCI were randomized to the education program (EP) or MST, where they learned to apply the technique to face-name associations during four intervening hour long training sessions. Participants underwent pre- and post-training fMRI scans, during which they encoded both the trained (i.e., those used during the four training sessions) and untrained ('novel') face-name associations. The primary cognitive outcome measures revealed significantly improved memory for both trained and novel stimuli - effects supporting near transfer of MST. Relative to pre-training, there were significant and highly similar increases in activation for both trained and novel stimuli, especially in regions associated with the frontoparietal cognitive control network bilaterally, but also in temporal areas related to social cognition and emotional processing. Critically, this pattern of activation was notably different from the EP group. Thus, the changes in activation were consistent with the strategies trained and, combined with the cognitively-based near transfer effects, suggest that MST focused on face-name association enhances performance by engaging cognitive control and social/emotional processing. Finally, our data indicated that our MST is a relevant and efficient intervention to a-MCI.",2020,"Relative to pre-training, there were significant and highly similar increases in activation for both trained and novel stimuli, especially in regions associated with the frontoparietal cognitive control network bilaterally, but also in temporal areas related to social cognition and emotional processing.","['thirty participants with a-MCI', 'patients with amnestic mild cognitive impairment (a-MCI', 'mild cognitive impairment']","['mnemonic strategy training', 'MST', 'education program (EP) or MST', 'mnemonic strategy training (MST']","['memory for both trained and novel stimuli - effects supporting near transfer of MST', 'social cognition and emotional processing']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}]","[{'cui': 'C0589105', 'cui_str': 'Strategy training (regime/therapy)'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}]","[{'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}]",30.0,0.0303448,"Relative to pre-training, there were significant and highly similar increases in activation for both trained and novel stimuli, especially in regions associated with the frontoparietal cognitive control network bilaterally, but also in temporal areas related to social cognition and emotional processing.","[{'ForeName': 'Sharon S', 'Initials': 'SS', 'LastName': 'Simon', 'Affiliation': 'Old Age Research Group (PROTER), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil. Electronic address: sharon.sanzsimon@gmail.com.'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Hampstead', 'Affiliation': 'Division of Neuropsychology, Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA; VA Ann Arbor Healthcare System, Ann Arbor, MI, USA.'}, {'ForeName': 'Mariana P', 'Initials': 'MP', 'LastName': 'Nucci', 'Affiliation': 'Neuroimagem funcional (NIF) - Laboratory of Medical Investigations on Magnetic Resonance Imaging (LIM-44), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Brazil.'}, {'ForeName': 'Fábio L S', 'Initials': 'FLS', 'LastName': 'Duran', 'Affiliation': 'Laboratory of Psychiatric Neuroimaging (LIM-21), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Luciana M', 'Initials': 'LM', 'LastName': 'Fonseca', 'Affiliation': 'Old Age Research Group (PROTER), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Maria da Graça M', 'Initials': 'MDGM', 'LastName': 'Martin', 'Affiliation': 'Neuroimagem funcional (NIF) - Laboratory of Medical Investigations on Magnetic Resonance Imaging (LIM-44), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Brazil.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Ávila', 'Affiliation': 'Old Age Research Group (PROTER), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Fábio H G', 'Initials': 'FHG', 'LastName': 'Porto', 'Affiliation': 'Old Age Research Group (PROTER), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Sônia M D', 'Initials': 'SMD', 'LastName': 'Brucki', 'Affiliation': 'Department of Neurology, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Camila B', 'Initials': 'CB', 'LastName': 'Martins', 'Affiliation': 'Department of Preventive Medicine, Paulista School of Medicine, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Lyssandra S', 'Initials': 'LS', 'LastName': 'Tascone', 'Affiliation': 'Old Age Research Group (PROTER), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil; Laboratory of Psychiatric Neuroimaging (LIM-21), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Edson', 'Initials': 'E', 'LastName': 'Amaro', 'Affiliation': 'Neuroimagem funcional (NIF) - Laboratory of Medical Investigations on Magnetic Resonance Imaging (LIM-44), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Brazil.'}, {'ForeName': 'Geraldo F', 'Initials': 'GF', 'LastName': 'Busatto', 'Affiliation': 'Laboratory of Psychiatric Neuroimaging (LIM-21), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Cássio M C', 'Initials': 'CMC', 'LastName': 'Bottino', 'Affiliation': 'Old Age Research Group (PROTER), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2019.03.014']
1347,31714309,Prophylaxis of Wound Infections-antibiotics in Renal Donation (POWAR): A UK Multicentre Double Blind Placebo Controlled Randomised Trial.,"BACKGROUND


Postoperative infection after hand-assisted laparoscopic donor nephrectomy (HALDN) confers significant morbidity to a healthy patient group. Current UK guidelines cite a lack of evidence for routine antibiotic prophylaxis. This trial assessed if a single preoperative antibiotic dose could reduce post HALDN infections.
METHODS


Eligible donors were randomly and blindly allocated to preoperative single-dose intravenous co-amoxiclav or saline. The primary composite endpoint was clinical evidence of any postoperative infection at 30 days, including surgical site infection (SSI), urinary tract infection (UTI), and lower respiratory tract infection (LRTI).
FINDINGS


In all, 293 participants underwent HALDN (148 antibiotic arm and 145 placebo arm). Among them, 99% (291/293) completed follow-up. The total infection rate was 40.7% (59/145) in the placebo group and 23% (34 of 148) in the antibiotic group (P = 0.001). Superficial SSIs were 20.7% (30/145 patients) in the placebo group versus 10.1% (15/148 patients) in the antibiotic group (P = 0.012). LRTIs were 9% (13/145) in the placebo group and 3.4% (5/148) in the antibiotic group (P = 0.046). UTIs were 4.1% (6/145) in the placebo group and 3.4% (5/148) in the antibiotic group (P = 0.72).Antibiotic prophylaxis conferred a 17.7% (95% confidence interval 7.2%-28.1%), absolute risk reduction in developing postoperative infection, with 6 donors requiring treatment to prevent 1 infection.
INTERPRETATION


Single-dose preoperative antibiotic prophylaxis dramatically reduces post-HALDN infection rates, mainly impacting SSIs and LRTIs.",2020,The total infection rate was 40.7% (59/145) in the placebo group and 23% (34 of 148) in the antibiotic group (P = 0.001).,"['healthy patient group', 'Eligible donors', '293 participants underwent HALDN (148 antibiotic arm and 145 placebo arm', 'Renal Donation (POWAR']","['hand-assisted laparoscopic donor nephrectomy (HALDN', 'Placebo', 'preoperative single-dose intravenous co-amoxiclav or saline', 'placebo']","['clinical evidence of any postoperative infection at 30 days, including surgical site infection (SSI), urinary tract infection (UTI), and lower respiratory tract infection (LRTI', 'LRTIs', 'Superficial SSIs', 'total infection rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4049936', 'cui_str': 'Donation'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0411257', 'cui_str': 'Donor nephrectomy (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0054066', 'cui_str': 'Amoxicillin / Clavulanate'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0392618', 'cui_str': 'Postoperative infection (disorder)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection (disorder)'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",293.0,0.709113,The total infection rate was 40.7% (59/145) in the placebo group and 23% (34 of 148) in the antibiotic group (P = 0.001).,"[{'ForeName': 'Zubir', 'Initials': 'Z', 'LastName': 'Ahmed', 'Affiliation': ""Department of Transplantation, Guy's & St Thomas' NHS Foundation Trust, King's College, London, UK.""}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Uwechue', 'Affiliation': ""Department of Transplantation, Guy's & St Thomas' NHS Foundation Trust, King's College, London, UK.""}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Chandak', 'Affiliation': ""Department of Transplantation, Guy's & St Thomas' NHS Foundation Trust, King's College, London, UK.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'van Dellen', 'Affiliation': 'Dept of Renal and Pancreas Transplantation, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Barwell', 'Affiliation': 'Renal Transplant Unit, Derriford Hospital, Plymouth Hospitals NHS Trust, Plymouth, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Heap', 'Affiliation': ""Renal Transplant Unit, St. George's Hospital, London, UK.""}, {'ForeName': 'Laszlo', 'Initials': 'L', 'LastName': 'Szabo', 'Affiliation': ""Department of Microbiology and Infection, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Hemsley', 'Affiliation': 'Department of Nephrology & Transplant Surgery, University Hospital of Wales, Cardiff & Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'Jonathon', 'Initials': 'J', 'LastName': 'Olsburgh', 'Affiliation': ""Department of Transplantation, Guy's & St Thomas' NHS Foundation Trust, King's College, London, UK.""}, {'ForeName': 'Nicos', 'Initials': 'N', 'LastName': 'Kessaris', 'Affiliation': ""Department of Transplantation, Guy's & St Thomas' NHS Foundation Trust, King's College, London, UK.""}, {'ForeName': 'Nizam', 'Initials': 'N', 'LastName': 'Mamode', 'Affiliation': ""Department of Transplantation, Guy's & St Thomas' NHS Foundation Trust, King's College, London, UK.""}]",Annals of surgery,['10.1097/SLA.0000000000003666']
1348,31678749,"Outdoor cycling improves clinical symptoms, cognition and objectively measured physical activity in patients with schizophrenia: A randomized controlled trial.","PURPOSE


The therapeutic effects of outdoor cycling (OC) and its benefits on physical activity (PA) were investigated in people with schizophrenia.
METHODS


Sixty patients with schizophrenia were randomly assigned to 16-weeks of Outdoor Cycling (OC) (n = 30, 50% male; mean age, 38.7 ± 10.1) or Occupational Therapy (OT) (n = 30, 50% male; mean age, 39.0 ± 8.6). OC and OT involved one 90-min group session per week. OC consisted of structured exercise programs and OT addressed daily living skills. Primary outcome measurements were mental health variables, such as Brief Psychiatric Rating Scale, Beck's Depression Inventory, State and Trait Anxiety Inventory, Rosenberg Self-Esteem Scale, Global Assessment of Functioning and executive function (Wisconsin Card Sorting Test, WCST). Secondary measures were the adherence and PA. PA was measured by responding to the Physical Activity Scale (K-PASE) and wearing a pedometer for 2 days.
RESULTS


Repeated measures ANOVA revealed improved psychotic symptoms (p = .014), depression (p = .007), state (p = .031) and trait anxiety (p = .002) and global functions (p = .024) in the OC group compared with OT group. The OC group showed increased correct rates (p = .022) and categories completed (p = .033) in the WCST. There was no difference in total K-PASE score between groups; however, there was a significant improvement in the number of daily steps in the OC group compared with the OT group (p = .030).
CONCLUSION


OC significantly improved mental health and executive function in individuals with schizophrenia. Further, OC significantly increased PA measured by the pedometers. These findings suggest that OC offers a safe and attrition-lowering intervention promoting mental health and PA.
TRIAL REGISTRATION


cris.nih.go.kr identifier: KCT-0000873.",2020,The OC group showed increased correct rates (p = .022) and categories completed (p = .033) in the WCST.,"['n\u202f=\u202f30, 50% male; mean age, 39.0\u202f±\u202f8.6', 'individuals with schizophrenia', 'patients with schizophrenia', 'n\u202f=\u202f30, 50% male; mean age, 38.7\u202f±\u202f10.1) or', 'people with schizophrenia', 'cris.nih.go.kr identifier', 'Sixty patients with schizophrenia']","['OC', 'outdoor cycling (OC', 'Outdoor cycling', 'OT', 'structured exercise programs and OT addressed daily living skills', 'Outdoor Cycling (OC', 'Occupational Therapy (OT']","[""mental health variables, such as Brief Psychiatric Rating Scale, Beck's Depression Inventory, State and Trait Anxiety Inventory, Rosenberg Self-Esteem Scale, Global Assessment of Functioning and executive function (Wisconsin Card Sorting Test, WCST"", 'mental health and executive function', 'total K-PASE score', 'clinical symptoms, cognition and objectively measured physical activity', 'physical activity (PA', 'depression', 'psychotic symptoms', 'adherence and PA', 'global functions', 'trait anxiety', 'number of daily steps', 'correct rates', 'PA', 'Physical Activity Scale (K-PASE']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517879', 'cui_str': '8.6 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0029941', 'cui_str': 'Overall and Gorham Brief Psychiatric Rating Scale'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0582666', 'cui_str': 'Rosenberg self-esteem scale (assessment scale)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0222045'}]",60.0,0.0566984,The OC group showed increased correct rates (p = .022) and categories completed (p = .033) in the WCST.,"[{'ForeName': 'Jehkwang', 'Initials': 'J', 'LastName': 'Ryu', 'Affiliation': 'Department of Physical Education, College of Education, Dongguk University, Seoul, Republic of Korea.'}, {'ForeName': 'Jae Hoon', 'Initials': 'JH', 'LastName': 'Jung', 'Affiliation': 'Department of Psychiatry and Mind-neuromodulation Laboratory, Hallym University College of Medicine, Chuncheon, Republic of Korea.'}, {'ForeName': 'Jiheon', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry and Mind-neuromodulation Laboratory, Hallym University College of Medicine, Chuncheon, Republic of Korea.'}, {'ForeName': 'Chan-Hyung', 'Initials': 'CH', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry and Institute of Behavioural Science in Medicine, Yonsei University, Yonsei University, College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hwa-Bock', 'Initials': 'HB', 'LastName': 'Lee', 'Affiliation': 'Gwangmyeong Community Mental Health Center, Gwangmyeong, Republic of Korea.'}, {'ForeName': 'Do-Hoon', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry and Mind-neuromodulation Laboratory, Hallym University College of Medicine, Chuncheon, Republic of Korea.'}, {'ForeName': 'Sang-Kyu', 'Initials': 'SK', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry and Mind-neuromodulation Laboratory, Hallym University College of Medicine, Chuncheon, Republic of Korea.'}, {'ForeName': 'Ji-Hyeon', 'Initials': 'JH', 'LastName': 'Shin', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Daeyoung', 'Initials': 'D', 'LastName': 'Roh', 'Affiliation': 'Department of Psychiatry and Mind-neuromodulation Laboratory, Hallym University College of Medicine, Chuncheon, Republic of Korea. Electronic address: omydoc@naver.com.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2019.10.015']
1349,31752954,A multicentre parallel-group randomised trial assessing multiparametric MRI characterisation and image-guided biopsy of prostate in men suspected of having prostate cancer: MULTIPROS study protocol.,"BACKGROUND


There is growing evidence suggesting that multiparametric magnetic resonance imaging (mpMRI) is a marker for prostate cancer (PCa) aggressiveness and could be used to plan treatment. Improving early detection of clinically significant PCa with pre-biopsy mpMRI would very likely have advantages including optimising the diagnosis and treatment of diseases and diminishing patient anxiety.
METHODS AND MATERIALS


This is a prospective multicentre study of pre-biopsy mpMRI diagnostic test accuracy with subgroup randomisation at a 1:1 ratio with respect to transrectal ultrasound (TRUS) and MRI/US fusion-guided biopsy or TRUS-only biopsy. It is designed as a single-gate study with a single set of inclusion criteria. The total duration of the recruitment phase was 48 months; however, this has now been extended to 66 months. A sample size of 600 participants is required.
DISCUSSION


The primary objective is to determine whether mpMRI can improve PCa detection and characterisation. The key secondary objective is to determine whether MRI/US fusion-guided biopsy can reduce the number of false-negative biopsies. Ethical approval was obtained from the East of Scotland Research Ethics Committee 1 (14/ES/1070) on 20 November 2014. The results of this study will be used for publication and presentation in national and international journals and at scientific conferences.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02745496. Retrospectively registered on 20 April 2016.",2019,"Improving early detection of clinically significant PCa with pre-biopsy mpMRI would very likely have advantages including optimising the diagnosis and treatment of diseases and diminishing patient anxiety.
","['600 participants is required', 'men suspected of having prostate cancer']","['MRI/US fusion-guided biopsy', 'mpMRI', 'multiparametric magnetic resonance imaging (mpMRI', 'multiparametric MRI characterisation and image-guided biopsy of prostate', 'transrectal ultrasound (TRUS) and MRI/US fusion-guided biopsy or TRUS-only biopsy']",['PCa detection and characterisation'],"[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0456852', 'cui_str': 'Image-Guided Biopsy'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0373345', 'cui_str': 'Transrectal ultrasound'}]","[{'cui': 'C0030625', 'cui_str': 'PCA'}]",600.0,0.158453,"Improving early detection of clinically significant PCa with pre-biopsy mpMRI would very likely have advantages including optimising the diagnosis and treatment of diseases and diminishing patient anxiety.
","[{'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Szewczyk-Bieda', 'Affiliation': 'Department of Clinical Radiology, Ninewells Hospital, Dundee, DD1 9SY, UK.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Wei', 'Affiliation': 'Division of Imaging Science and Technology, School of Medicine, University of Dundee, Ninewells Hospital, Dundee, DD1 9SY, UK.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Coll', 'Affiliation': 'Tayside Clinical Trials Unit (TCTU), Tayside Medical Science Centre (TASC), University of Dundee, Ninewells Hospital, Dundee, DD1 9SY, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Gandy', 'Affiliation': 'Department of Medical Physics, Ninewells Hospital, Dundee, DD1 9SY, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Donnan', 'Affiliation': 'Division of Population Health Genomics, University of Dundee, Dundee, DD2 4BF, UK.'}, {'ForeName': 'Senthil Kumar Arcot', 'Initials': 'SKA', 'LastName': 'Ragupathy', 'Affiliation': 'Department of Clinical Radiology, Aberdeen Royal Infirmary, Aberdeen, AB25 2ZN, UK.'}, {'ForeName': 'Paras', 'Initials': 'P', 'LastName': 'Singh', 'Affiliation': 'Royal Free London NHS Foundation Trust, Royal Free Hospital, London, NW3 2QG, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wilson', 'Affiliation': 'Department of Clinical Pathology, Ninewells Hospital, Dundee, DD1 9SY, UK.'}, {'ForeName': 'Ghulam', 'Initials': 'G', 'LastName': 'Nabi', 'Affiliation': 'Division of Imaging Science and Technology, School of Medicine, University of Dundee, Ninewells Hospital, Dundee, DD1 9SY, UK. g.nabi@dundee.ac.uk.'}]",Trials,['10.1186/s13063-019-3746-0']
1350,30943777,Standard and accelerated corneal cross-linking long-term results: A randomized clinical trial.,"PURPOSE


To compare long-term results between accelerated and standard corneal cross-linking protocols in the treatment of progressive keratoconus and compare their effectiveness between central (cone in the central 3 mm) and peripheral (cone beyond 3 mm) cases.
METHODS


In this randomized clinical trial, we compared 31 eyes treated with accelerated corneal cross-linking (18 mW/cm 2 , 5 min) and 31 eyes treated with standard corneal cross-linking (3 mW/cm 2 , 30 min), 16 central and 11 peripheral keratoconus in each group. In this report, 4-year changes in vision, refraction, topography, corneal biomechanics, and corneal cell count were evaluated.
RESULTS


Uncorrected distance visual acuity improvement was better with standard corneal cross-linking (0.19 ± 0.30 logMAR) than accelerated corneal cross-linking (0.08 ± 0.35 logMAR), but the intergroup difference was not statistically significant (p = 0.283). Cylinder and spherical equivalent significantly increased similarly in both groups. Among topographic indices, anterior Kmax-3 mm showed more reduction in standard corneal cross-linking than accelerated corneal cross-linking (1.35 ± 1.39 vs 0.36 ± 1.10 D, p = 0.011). Anterior Kmax-8 mm reduced by 1.50 ± 1.82 and 0.37 ± 1.58 D in the standard corneal cross-linking and accelerated corneal cross-linking groups, respectively (p = 0.029). Compared to 18-month results, none of the indices at 4 years showed any significant intergroup difference (all p > 0.05). In cases with peripheral keratoconus, changes in anterior Kmax-3 mm (+0.03 ± 0.66 vs -1.17 ± 1.15 D, p = 0.012) and anterior Kmax-8 mm (+0.43 ± 1.09 vs -1.57 ± 1.40 D, p = 0.003) were greater with standard corneal cross-linking. In central cases, no significant intergroup difference was observed.
CONCLUSION


At 4 years after the procedure, standard corneal cross-linking offered better anterior corneal flattening in the center and periphery. These differences concerned cases of peripheral keratoconus, and the two protocols were similarly effective in central cases. Beyond the 18th month, the two protocols appeared to be similarly effective.",2019,"At 4 years after the procedure, standard corneal cross-linking offered better anterior corneal flattening in the center and periphery.","['31 eyes treated with accelerated corneal cross-linking (18\u2009mW/cm 2 , 5\u2009min) and 31 eyes treated with']","['accelerated and standard corneal cross-linking protocols', 'standard corneal cross-linking']","['Uncorrected distance visual acuity improvement', 'Cylinder and spherical equivalent', '4-year changes in vision, refraction, topography, corneal biomechanics, and corneal cell count']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C4319645', 'cui_str': 'Cylinder (unit of presentation)'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0430943', 'cui_str': 'Refraction'}, {'cui': 'C0007584', 'cui_str': 'Cell Number'}]",,0.0477401,"At 4 years after the procedure, standard corneal cross-linking offered better anterior corneal flattening in the center and periphery.","[{'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Hashemi', 'Affiliation': 'Noor Research Center for Ophthalmic Epidemiology, Noor Eye Hospital, Tehran, Iran.'}, {'ForeName': 'Masoomeh', 'Initials': 'M', 'LastName': 'Mohebbi', 'Affiliation': 'Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Soheila', 'Initials': 'S', 'LastName': 'Asgari', 'Affiliation': 'Noor Ophthalmology Research Center, Noor Eye Hospital, Tehran, Iran.'}]",European journal of ophthalmology,['10.1177/1120672119839927']
1351,30943128,¡Activate Ya! Co-learning about school-based tobacco prevention and physical activity promotion in secondary school students in Uruguay.,"PURPOSE


¡Activate Ya! was a group-randomized controlled intervention trial aimed at developing and evaluating the impact of a school-based intervention on preventing cigarette smoking and promoting physical activity (PA) in secondary school students in Uruguay. Secondary aims were to evaluate the program's impact on students' smoking- and PA-related psychosocial risk and protective factors.
METHODS


Sixteen schools and  n  = 654 students participated in the study. The one-year intervention included a classroom-based curriculum, an afterschool program, activity breaks, and final showcase event. A self-administered questionnaire measured outcomes at three time points. Fixed effects regression models tested for differences in outcomes by study condition.
RESULTS


While positive intervention effects were found for selected psychosocial-related smoking outcomes, no impact on past-year smoking or smoking susceptibility was detected. Past 7-day PA, measured by the PAQ-C, was significantly higher among intervention school students overall ( p  = .048) and for girls ( p  = .03) at posttest, and intervention girls reported significantly higher athletic identity PA competence, friend and teacher PA support at posttest, and PA enjoyment at follow-up ( p  < .05).
CONCLUSION


The positive short-term effects of ¡Activate Ya! on PA and related outcomes for girls support the utility of school-based health promotion in Uruguay. Additional research is needed to determine the most effective strategies to prevent tobacco use among students and promote PA among boys in this setting.",2019,"While positive intervention effects were found for selected psychosocial-related smoking outcomes, no impact on past-year smoking or smoking susceptibility was detected.","['\n\n\nSixteen schools and n = 654 students participated in the study', 'secondary school students in Uruguay']","['school-based intervention', 'classroom-based curriculum, an afterschool program, activity breaks, and final showcase event', 'Activate Ya', 'Activate Ya! Co-learning about school-based tobacco prevention and physical activity promotion']","['cigarette smoking and promoting physical activity (PA', ""students' smoking- and PA-related psychosocial risk and protective factors"", 'athletic identity PA competence, friend and teacher PA support at posttest, and PA enjoyment', 'selected psychosocial-related smoking outcomes, no impact on past-year smoking or smoking susceptibility']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0036530', 'cui_str': 'Schools, Secondary'}, {'cui': 'C0042113', 'cui_str': 'Uruguay'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]","[{'cui': 'C0239059', 'cui_str': 'Cigarette smoke (substance)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0679688', 'cui_str': 'Protective Factors'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0079382', 'cui_str': 'Friend (person)'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}]",654.0,0.0188797,"While positive intervention effects were found for selected psychosocial-related smoking outcomes, no impact on past-year smoking or smoking susceptibility was detected.","[{'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Springer', 'Affiliation': 'Michael & Susan Dell Center for Healthy Living, University of Texas Health Science Center at Houston School of Public Health, Austin, USA.'}, {'ForeName': 'Melissa B', 'Initials': 'MB', 'LastName': 'Harrell', 'Affiliation': 'Michael & Susan Dell Center for Healthy Living, University of Texas Health Science Center at Houston School of Public Health, Austin, USA.'}, {'ForeName': 'Lucía', 'Initials': 'L', 'LastName': 'Martínez Gomensoro', 'Affiliation': 'Centro de Investigación para la Epidemia del Tabaquismo (CIET), Montevideo, Uruguay.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Traversa Fresco', 'Affiliation': 'Centro de Investigación para la Epidemia del Tabaquismo (CIET), Montevideo, Uruguay.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Rogers', 'Affiliation': 'Michael & Susan Dell Center for Healthy Living, University of Texas Health Science Center at Houston School of Public Health, Austin, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Florines', 'Affiliation': 'Centro de Investigación para la Epidemia del Tabaquismo (CIET), Montevideo, Uruguay.'}, {'ForeName': 'Viviana', 'Initials': 'V', 'LastName': 'Moreno', 'Affiliation': 'Centro de Investigación para la Epidemia del Tabaquismo (CIET), Montevideo, Uruguay.'}, {'ForeName': 'Joowon', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Michael & Susan Dell Center for Healthy Living, University of Texas Health Science Center at Houston School of Public Health, Austin, USA.'}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Perry', 'Affiliation': 'Michael & Susan Dell Center for Healthy Living, University of Texas Health Science Center at Houston School of Public Health, Austin, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bianco', 'Affiliation': 'Centro de Investigación para la Epidemia del Tabaquismo (CIET), Montevideo, Uruguay.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Estol', 'Affiliation': 'Centro de Investigación para la Epidemia del Tabaquismo (CIET), Montevideo, Uruguay.'}]",Global health promotion,['10.1177/1757975918813049']
1352,28796940,Telephone-Based Depression Care Management for Postpartum Women: A Randomized Controlled Trial.,"OBJECTIVE


With a period prevalence of 21.9% in the year after birth, depression is a common complication of childbearing. We assessed the impact of telephone-delivered depression care management (DCM) on symptom levels, health service utilization, and functional status 3, 6, and 12 months postpartum.
METHODS


The randomized controlled trial was conducted at the University of Pittsburgh, Pittsburgh, Pennsylvania, from March 2006 through September 2010. Women (N = 628) who screened positive for depression (a score of 10 or greater on the Edinburgh Postnatal Depression Scale) 4 to 6 weeks postpartum were evaluated with the Structured Clinical Interview for DSM-IV-TR Axis I Disorders, Research Version, Patient Edition With Psychotic Screen and enrolled in a randomized trial of DCM compared to enhanced usual care (EUC). Clinicians conducted telephone contacts to educate, assist with treatment decisions, monitor symptoms, facilitate access to services, and encourage links to community resources. Independent evaluators collected symptom scores, functional status, and health services use at 3, 6, and 12 months postpartum. Primary outcome was reduction of symptoms as measured by the Structured Interview Guide for the Hamilton Depression Rating Scale with Atypical Depression Supplement.
RESULTS


Mean depressive symptom and function scores significantly improved (by greater than 50%) in both groups of women but did not differ by DCM versus EUC assignment. Health services use was similar in women randomly assigned to DCM compared to EUC. Women with childhood sexual abuse responded significantly more favorably to DCM on depression and functional measures (all P values < .02).
CONCLUSIONS


Both DCM and EUC favorably impacted depression symptom levels and function. The subgroup of women with childhood sexual abuse benefited significantly more from DCM compared to the EUC condition. Regular telephone availability of a clinician is a resource that appears to be particularly therapeutic to women with childhood sexual abuse.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT00282776.",2017,Mean depressive symptom and function scores significantly improved (by greater than 50%) in both groups of women but did not differ by DCM versus EUC assignment.,"['Women (N = 628) who screened positive for depression (a score of 10 or greater on the Edinburgh Postnatal Depression Scale) 4 to 6 weeks postpartum were evaluated with the Structured Clinical Interview for DSM-IV-TR Axis', 'women with childhood sexual abuse', 'Postpartum Women', 'Women with childhood sexual abuse', 'University of Pittsburgh, Pittsburgh, Pennsylvania, from March 2006 through September 2010']","['DCM', 'DCM and EUC', 'telephone-delivered depression care management (DCM', 'Telephone-Based Depression Care Management']","['reduction of symptoms as measured by the Structured Interview Guide for the Hamilton Depression Rating Scale with Atypical Depression Supplement', 'symptom scores, functional status, and health services use', 'Mean depressive symptom and function scores', 'depression and functional measures']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh Postnatal Depression Scale'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0199182', 'cui_str': 'Taking health history'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0282350', 'cui_str': 'Sexual abuse (event)'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C4708576', 'cui_str': 'Depression care management'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0205182', 'cui_str': 'Atypical (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.143457,Mean depressive symptom and function scores significantly improved (by greater than 50%) in both groups of women but did not differ by DCM versus EUC assignment.,"[{'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Wisner', 'Affiliation': '676 N St Clair St, Ste 1000, Chicago, IL 60611. katherine.wisner@northwestern.edu.'}, {'ForeName': 'Dorothy K Y', 'Initials': 'DKY', 'LastName': 'Sit', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'McShea', 'Affiliation': 'VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Luther', 'Affiliation': 'Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Heather F', 'Initials': 'HF', 'LastName': 'Eng', 'Affiliation': 'Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Dills', 'Affiliation': 'Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Eydie L', 'Initials': 'EL', 'LastName': 'Moses-Kolko', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Wisniewski', 'Affiliation': 'Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}]",The Journal of clinical psychiatry,['10.4088/JCP.15m10563']
1353,31711168,Effect of Electronic Health Record-Based Coaching on Weight Maintenance: A Randomized Trial.,"Background


Weight regain after intentional loss is common. Most evidence-based weight management programs focus on short-term loss rather than long-term maintenance.
Objective


To evaluate the benefit of coaching in an electronic health record (EHR)-based weight maintenance intervention.
Design


Randomized controlled trial. (ClinicalTrials.gov: NCT01946191).
Setting


Practices affiliated with an academic medical center.
Participants


Adult outpatients with body mass index (BMI) of 25 kg/m2 or higher, intentional weight loss of at least 5% in the previous 2 years, and no bariatric procedures in the previous 5 years.
Intervention


Participants were randomly assigned to EHR tools (tracking group) versus EHR tools plus coaching (coaching group). The EHR tools included weight, diet, and physical activity tracking flow sheets; standardized surveys; and reminders. The coaching group received 24 months of personalized coaching through the EHR patient portal, with 24 scheduled contacts.
Measurements


The primary outcome was weight change at 24 months. Secondary outcomes included 5% weight loss maintenance and changes in BMI, waist circumference, number of steps per day, health-related quality of life, physical function, blood pressure, and satisfaction.
Results


Among 194 randomly assigned participants (mean age, 53.4 years [SD, 12.2]; 143 [74%] women; 171 [88%] white), 157 (81%) completed the trial. Mean baseline weight and BMI were 85.8 kg (SD, 19.1) and 30.4 kg/m2 (SD, 5.9). At 24 months, mean weight regain (± SE) was 2.1 ± 0.62 kg and 4.9 ± 0.63 kg in the coaching and tracking groups, respectively. The between-group difference in weight change at 24 months was significant (-2.86 kg [95% CI, -4.60 to -1.11 kg]) in the linear mixed model. At 24 months, 65% of participants in the coaching group and 50% in the tracking group maintained weight loss of at least 5%.
Limitation


Single-site trial, which limits generalizability.
Conclusion


Among adults with intentional weight loss of at least 5%, use of EHR tools plus coaching resulted in less weight regain than EHR tools alone.
Primary Funding Source


Agency for Healthcare Research and Quality and National Institutes of Health.",2019,"At 24 months, 65% of participants in the coaching group and 50% in the tracking group maintained weight loss of at least 5%.
","['adults with', '194 randomly assigned participants (mean age, 53.4 years [SD, 12.2', '143 [74%] women; 171 [88%] white), 157 (81%) completed the trial', 'Participants\n\n\nAdult outpatients with body mass index (BMI) of 25 kg/m2 or higher, intentional weight loss of at least 5% in the previous 2 years, and no bariatric procedures in the previous 5 years', 'Setting\n\n\nPractices affiliated with an academic medical center']","['Electronic Health Record-Based Coaching', 'EHR tools (tracking group) versus EHR tools plus coaching (coaching group', 'personalized coaching through the EHR patient portal, with 24 scheduled contacts']","['weight change', 'Mean baseline weight and BMI', '5% weight loss maintenance and changes in BMI, waist circumference, number of steps per day, health-related quality of life, physical function, blood pressure, and satisfaction', 'mean weight regain (±\xa0SE', 'weight loss', 'intentional weight loss', 'weight regain', 'Weight Maintenance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1563041', 'cui_str': 'Intentional weight loss'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}]","[{'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C4277550', 'cui_str': 'Patient Internet Portals'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1303013', 'cui_str': 'Baseline weight'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1563041', 'cui_str': 'Intentional weight loss'}]",194.0,0.154702,"At 24 months, 65% of participants in the coaching group and 50% in the tracking group maintained weight loss of at least 5%.
","[{'ForeName': 'Molly B', 'Initials': 'MB', 'LastName': 'Conroy', 'Affiliation': 'University of Utah, Salt Lake City, Utah (M.B.C., R.H.).'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'McTigue', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania (K.M.M., C.L.B., D.T., B.B.G., J.A., D.C., K.H., L.R.S., G.S.F.).'}, {'ForeName': 'Cindy L', 'Initials': 'CL', 'LastName': 'Bryce', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania (K.M.M., C.L.B., D.T., B.B.G., J.A., D.C., K.H., L.R.S., G.S.F.).'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Tudorascu', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania (K.M.M., C.L.B., D.T., B.B.G., J.A., D.C., K.H., L.R.S., G.S.F.).'}, {'ForeName': 'Bethany Barone', 'Initials': 'BB', 'LastName': 'Gibbs', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania (K.M.M., C.L.B., D.T., B.B.G., J.A., D.C., K.H., L.R.S., G.S.F.).'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Arnold', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania (K.M.M., C.L.B., D.T., B.B.G., J.A., D.C., K.H., L.R.S., G.S.F.).'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Comer', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania (K.M.M., C.L.B., D.T., B.B.G., J.A., D.C., K.H., L.R.S., G.S.F.).'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Hess', 'Affiliation': 'University of Utah, Salt Lake City, Utah (M.B.C., R.H.).'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania (K.M.M., C.L.B., D.T., B.B.G., J.A., D.C., K.H., L.R.S., G.S.F.).'}, {'ForeName': 'Laurey R', 'Initials': 'LR', 'LastName': 'Simkin-Silverman', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania (K.M.M., C.L.B., D.T., B.B.G., J.A., D.C., K.H., L.R.S., G.S.F.).'}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Fischer', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania (K.M.M., C.L.B., D.T., B.B.G., J.A., D.C., K.H., L.R.S., G.S.F.).'}]",Annals of internal medicine,['10.7326/M18-3337']
1354,30928620,"Patient-reported outcomes in patients with resected, high-risk melanoma with BRAF V600E  or BRAF V600K  mutations treated with adjuvant dabrafenib plus trametinib (COMBI-AD): a randomised, placebo-controlled, phase 3 trial.","BACKGROUND


In the phase 3 COMBI-AD study, patients with resected, stage III melanoma with BRAF V600E  or BRAF V600K  mutations received adjuvant dabrafenib plus trametinib or placebo. The primary analysis showed that dabrafenib plus trametinib significantly improved relapse-free survival at 3 years. These results led to US Food and Drug Administration approval of dabrafenib plus trametinib as adjuvant treatment for patients with resected stage III melanoma with BRAF V600E  or BRAF V600K  mutations. Here, we report the patient-reported outcomes from COMBI-AD.
METHODS


COMBI-AD was a randomised, double-blind, placebo-controlled, phase 3 study done at 169 sites in 25 countries. Study participants were aged 18 years or older and had complete resection of stage IIIA (lymph node metastases >1 mm), IIIB, or IIIC cutaneous melanoma as per American Joint Committee on Cancer 7th edition criteria, with BRAF V600E  or BRAF V600K  mutations, and an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients were randomly assigned (1:1) via an interactive voice response system, stratified by mutation type and disease stage, to receive oral dabrafenib (150 mg twice daily) plus oral trametinib (2 mg once daily) or matching placebos for 12 months. Patients, physicians, and the investigators who analysed the data were masked to treatment allocation. The primary endpoint was relapse-free survival, reported elsewhere. Health-related quality of life, reported here, was a prespecified exploratory endpoint, and was assessed with the European Quality of Life 5-Dimensions 3-Levels (EQ-5D-3L) questionnaire in the intention-to-treat population. We used a mixed-model repeated-measures analysis to assess differences in health-related quality of life between groups. This study is registered with ClinicalTrials.gov, number NCT01682083. The trial is ongoing, but is no longer recruiting participants.
FINDINGS


Between Jan 31, 2013, and Dec 11, 2014, 870 patients were enrolled and randomly assigned to receive dabrafenib plus trametinib (n=438) or matching placebos (n=432). Data were collected until the data cutoff for analyses of the primary endpoint (June 30, 2017). The median follow-up was 34 months (IQR 28-39) in the dabrafenib plus trametinib group and 33 months (20·5-39) in the placebo group. During the 12-month treatment phase, there were no significant or clinically meaningful changes from baseline between groups in EQ-5D-3L visual analogue scale (EQ-VAS) or utility scores. During treatment, there were no clinically meaningful differences in VAS scores or utility scores in the dabrafenib plus trametinib group between patients who did and did not experience the most common adverse events. During long-term follow-up (range 15-48 months), VAS and utility scores were similar between groups and did not differ from baseline scores. At recurrence, there were significant decreases in VAS scores in both the dabrafenib plus trametinib group (mean change -6·02, SD 20·57; p=0·0032) and the placebo group (-6·84, 20·86; p<0·0001); the mean change in utility score also differed significantly at recurrence for both groups (dabrafenib plus trametinib -0·0626, 0·1911, p<0·0001; placebo -0·0748, 0·2182, p<0·0001).
INTERPRETATION


These findings show that dabrafenib plus trametinib did not affect patient-reported outcome scores during or after adjuvant treatment, and suggest that preventing or delaying relapse with adjuvant therapy could be beneficial in this setting.
FUNDING


Novartis.",2019,"During long-term follow-up (range 15-48 months), VAS and utility scores were similar between groups and did not differ from baseline scores.","['COMBI-AD', '169 sites in 25 countries', 'Study participants were aged 18 years or older and had complete resection of stage IIIA (lymph node metastases >1 mm), IIIB, or IIIC cutaneous melanoma as per American Joint Committee on Cancer 7th edition criteria, with BRAF V600E  or BRAF V600K  mutations, and an Eastern Cooperative Oncology Group performance status of 0 or 1', 'Between Jan 31, 2013, and Dec 11, 2014, 870 patients', 'patients with resected, stage III melanoma with BRAF V600E  or BRAF V600K  mutations received', 'patients with resected stage III melanoma with BRAF V600E  or BRAF V600K  mutations', 'patients with resected, high-risk melanoma with BRAF V600E  or BRAF V600K  mutations treated with']","['dabrafenib plus trametinib (n=438) or matching placebos', 'placebo', 'interactive voice response system, stratified by mutation type and disease stage, to receive oral dabrafenib (150 mg twice daily) plus oral trametinib (2 mg once daily) or matching placebos', 'adjuvant dabrafenib plus trametinib (COMBI-AD', 'adjuvant dabrafenib plus trametinib or placebo']","['VAS scores or utility scores', 'European Quality of Life 5-Dimensions 3-Levels (EQ-5D-3L) questionnaire', 'relapse-free survival', 'VAS scores', 'EQ-5D-3L visual analogue scale (EQ-VAS) or utility scores', 'mean change in utility score', 'health-related quality of life', 'VAS and utility scores']","[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0457162', 'cui_str': 'Stage IIIa'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C4280965', 'cui_str': '>1'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C3467876', 'cui_str': 'dabrafenib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2697961', 'cui_str': 'trametinib'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0034380'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",870.0,0.791105,"During long-term follow-up (range 15-48 months), VAS and utility scores were similar between groups and did not differ from baseline scores.","[{'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Germany; German Cancer Consortium, Heidelberg, Germany. Electronic address: dirk.schadendorf@uk-essen.de.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Hauschild', 'Affiliation': 'University Hospital Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Santinami', 'Affiliation': 'Fondazione Istituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Atkinson', 'Affiliation': 'Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, QLD, Australia.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Mandalà', 'Affiliation': 'Papa Giovanni XXIII Cancer Center Hospital, Bergamo, Italy.'}, {'ForeName': 'Vanna', 'Initials': 'V', 'LastName': 'Chiarion-Sileni', 'Affiliation': 'Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padova, Italy.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Nyakas', 'Affiliation': 'Oslo University Hospital, The Norwegian Radium Hospital, Oslo, Norway.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dutriaux', 'Affiliation': 'Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux, France.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Haydon', 'Affiliation': 'The Alfred Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Institute Gustave Roussy, Paris, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Mortier', 'Affiliation': 'Université de Lille, INSERM U 1189, Lille, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lesimple', 'Affiliation': 'Medical Oncology Department, Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Plummer', 'Affiliation': 'Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Schachter', 'Affiliation': 'Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, Israel; Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Kohinoor', 'Initials': 'K', 'LastName': 'Dasgupta', 'Affiliation': 'Novartis Healthcare, Hyderabad, India.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Manson', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Koruth', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'Bijoyesh', 'Initials': 'B', 'LastName': 'Mookerjee', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kefford', 'Affiliation': 'Macquarie University, Sydney, NSW, Australia; Melanoma Institute Australia, Sydney, NSW, Australia; Westmead Hospital, Sydney, NSW, Australia; The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Dummer', 'Affiliation': 'University Hospital Zürich Skin Cancer Center, Zürich, Switzerland.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kirkwood', 'Affiliation': 'Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'Melanoma Institute Australia, Sydney, NSW, Australia; The University of Sydney, Sydney, NSW, Australia; Royal North Shore Hospital, Sydney, NSW, Australia; Mater Hospital, Sydney, NSW, Australia.'}]",The Lancet. Oncology,['10.1016/S1470-2045(18)30940-9']
1355,30897067,THE EFFECT OF AGE ON AFLIBERCEPT (EYLEA) RESPONSE IN DIABETIC MACULAR EDEMA.,"PURPOSE


To investigate the effect of age on aflibercept (Eylea) response in macular edema secondary to treatment-naive diabetic eyes.
METHODS


Two hundred seventy-three eyes of 273 treatment-naive patients with macular edema secondary to diabetes mellitus were enrolled in this study. The patients in the study were divided into the following 4 groups according to their ages: Group 1 (40-50 years), Group 2 (51-60 years), Group 3 (61-70 years), and Group 4 (>70 years). Three consecutive injections at intervals of 1 month were applied to all diabetic patients. The efficacy of the aflibercept treatment on macular edema according to age groups was assessed by optical coherence tomography by comparing the central foveal thickness (CFT) values and mean visual acuity changes after initial and three loading dose injections.
RESULTS


After three consecutive aflibercept injections, the mean reduction of CFT in Groups 1, 2, 3, and 4 were -256.4 ± 110.9, -197.4 ± 96.4, -189.4 ± 110.8, and -186.2 ± 118.9 µm, respectively. The changes of CFT was significantly different between age groups (P = 0.003, analysis of covariance). The improvement of visual acuity was significantly different in each group (P < 0.001 in all groups, paired-samples t-test), and changes of visual acuity was significantly different between age groups (P < 0.05, analysis of covariance). In addition, ages of patients were correlated with the mean reduction of CFT and mean improvement of visual acuity for the whole study group (r = -0.183, P = 0.002 for CFT; r = -0.682, P < 0.001 for visual acuity, Pearson correlation).
CONCLUSION


In this study, it was observed that the efficacy of aflibercept treatment was found to be more effective in younger patients in treatment-naive diabetic macular edema patients.",2020,"The changes of CFT was significantly different between age groups (P = 0.003, analysis of covariance).","['younger patients in treatment-naive diabetic macular edema patients', 'macular edema secondary to treatment-naive diabetic eyes', 'Two hundred seventy-three eyes of 273 treatment-naive patients with macular edema secondary to diabetes mellitus']","['aflibercept', 'aflibercept (Eylea) response', 'THE EFFECT OF AGE ON AFLIBERCEPT (EYLEA']","['macular edema', 'changes of CFT', 'visual acuity', 'changes of visual acuity', 'central foveal thickness (CFT) values and mean visual acuity changes', 'improvement of visual acuity', 'mean reduction of CFT']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C0271051', 'cui_str': 'Macular Edema'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3248025', 'cui_str': 'Eylea'}]","[{'cui': 'C0271051', 'cui_str': 'Macular Edema'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",273.0,0.0287596,"The changes of CFT was significantly different between age groups (P = 0.003, analysis of covariance).","[{'ForeName': 'Cemal', 'Initials': 'C', 'LastName': 'Ozsaygili', 'Affiliation': 'Kayseri City Training and Research Hospital, Kocasinan, Kayseri, Turkey.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Duru', 'Affiliation': ''}, {'ForeName': 'Ayse', 'Initials': 'A', 'LastName': 'Cicek', 'Affiliation': ''}, {'ForeName': 'Dondu Melek', 'Initials': 'DM', 'LastName': 'Ulusoy', 'Affiliation': ''}, {'ForeName': 'Atilim Armagan', 'Initials': 'AA', 'LastName': 'Demirtas', 'Affiliation': ''}, {'ForeName': 'Necati', 'Initials': 'N', 'LastName': 'Duru', 'Affiliation': ''}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002504']
1356,30922731,"Lenvatinib plus pembrolizumab in patients with advanced endometrial cancer: an interim analysis of a multicentre, open-label, single-arm, phase 2 trial.","BACKGROUND


Lenvatinib is a multikinase inhibitor of VEGFR1, VEGFR2, and VEGFR3, and other receptor tyrosine kinases. Pembrolizumab, an antibody targeting PD-1, has moderate efficacy in biomarker-unselected endometrial cancer. We aimed to assess the combination of lenvatinib plus pembrolizumab in patients with advanced endometrial carcinoma, after establishing the maximum tolerated dose in a phase 1b study.
METHODS


In this open-label, single-arm, phase 2 study done at 11 centres in the USA, eligible patients were aged 18 years or older and had metastatic endometrial cancer (unselected for microsatellite instability or PD-L1), had an Eastern Cooperative Oncology Group performance status of 0 or 1, had received no more than two previous systemic therapies, had measurable disease according to the immune-related Response Evaluation Criteria In Solid Tumors (irRECIST), and had a life expectancy of 12 weeks or longer. Patients received 20 mg oral lenvatinib daily plus 200 mg intravenous pembrolizumab every 3 weeks. Treatment continued until disease progression, development of unacceptable toxic effects, or withdrawal of consent. The primary endpoint of this interim analysis was the proportion of patients with an objective response at week 24 as assessed by investigators according to irRECIST in the per-protocol population. This trial is registered with ClinicalTrials.gov, number NCT02501096.
FINDINGS


Between Sept 10, 2015, and July 24, 2017, 54 patients were enrolled, 53 of whom were included in the analysis. At the cutoff date for anti-tumour activity data (Dec 15, 2017), median study follow-up was 13·3 months (IQR 6·7-20·1). 21 (39·6% [95% CI 26·5-54·0]) patients had an objective response at week 24. Serious treatment-related adverse events occurred in 16 (30%) patients, and one treatment-related death was reported (intracranial haemorrhage). The most frequently reported any-grade treatment-related adverse events were hypertension (31 [58%]), fatigue (29 [55%]), diarrhoea (27 [51%]), and hypothyroidism (25 [47%]). The most common grade 3 treatment-related adverse events were hypertension (18 [34%]) and diarrhoea (four [8%]). No grade 4 treatment-related adverse events were reported. Five (9%) patients discontinued study treatment because of treatment-related adverse events.
INTERPRETATION


Lenvatinib plus pembrolizumab showed anti-tumour activity in patients with advanced recurrent endometrial cancer with a safety profile that was similar to those previously reported for lenvatinib and pembrolizumab monotherapies, apart from an increased frequency of hypothyroidism. Lenvatinib plus pembrolizumab could represent a new potential treatment option for this patient population, and is being investigated in a randomised phase 3 study.
FUNDING


Eisai and Merck.",2019,"Serious treatment-related adverse events occurred in 16 (30%) patients, and one treatment-related death was reported (intracranial haemorrhage).","['patients with advanced endometrial carcinoma, after establishing the maximum tolerated dose in a phase 1b study', 'patients with advanced endometrial cancer', '54 patients were enrolled, 53 of whom were included in the analysis', 'patients with advanced recurrent endometrial cancer', '11 centres in the USA, eligible patients were aged 18 years or older and had metastatic endometrial cancer (unselected for microsatellite instability or PD-L1), had an Eastern Cooperative Oncology Group performance status of 0 or 1, had received no more than two previous systemic therapies, had measurable disease according to the immune-related Response Evaluation Criteria In Solid Tumors (irRECIST), and had a life expectancy of 12 weeks or longer', 'Between Sept 10, 2015, and July 24, 2017']","['Pembrolizumab', 'lenvatinib plus pembrolizumab', 'Lenvatinib plus pembrolizumab', '20 mg oral lenvatinib daily plus 200 mg intravenous pembrolizumab']","['fatigue', 'proportion of patients with an objective response', 'adverse events', 'diarrhoea', 'objective response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0752079', 'cui_str': 'Maximally Tolerated Dose'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0920269', 'cui_str': 'Microsatellite Instability'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C2986924', 'cui_str': 'lenvatinib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",54.0,0.368983,"Serious treatment-related adverse events occurred in 16 (30%) patients, and one treatment-related death was reported (intracranial haemorrhage).","[{'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Makker', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA. Electronic address: makkerV@mskcc.org.'}, {'ForeName': 'Drew', 'Initials': 'D', 'LastName': 'Rasco', 'Affiliation': 'START, San Antonio, TX, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Vogelzang', 'Affiliation': 'Comprehensive Cancer Centers of Nevada and US Oncology Research, Las Vegas, NV, USA.'}, {'ForeName': 'Marcia S', 'Initials': 'MS', 'LastName': 'Brose', 'Affiliation': 'Perelman Center for Advanced Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Allen L', 'Initials': 'AL', 'LastName': 'Cohn', 'Affiliation': 'Rocky Mountain Cancer Center and US Oncology Research, Denver, CO, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Mier', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Di Simone', 'Affiliation': 'Arizona Oncology Associates and US Oncology Research, Tucson, AZ, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Hyman', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Stepan', 'Affiliation': 'Eisai, Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Corina E', 'Initials': 'CE', 'LastName': 'Dutcus', 'Affiliation': 'Eisai, Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Emmett V', 'Initials': 'EV', 'LastName': 'Schmidt', 'Affiliation': 'Merck, Kenilworth, NJ, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Guo', 'Affiliation': 'Eisai, Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Pallavi', 'Initials': 'P', 'LastName': 'Sachdev', 'Affiliation': 'Eisai, Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Shumaker', 'Affiliation': 'Eisai, Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Aghajanian', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Taylor', 'Affiliation': 'Knight Cancer Institute, Oregon Health and Science University, Portland, OR, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30020-8']
1357,30771560,Arriba por la Vida Estudio (AVE): Study protocol for a standing intervention targeting postmenopausal Latinas.,"BACKGROUND


Postmenopausal Latinas are a growing population group in the US who are at high risk for cardiovascular disease. Epidemiological studies have shown that excessive sitting is related to cardiovascular disease risk. Older women sit for prolonged periods and most individuals do not meet physical activity guidelines. Reducing sitting through increased standing may improve cardiovascular risk. More research is needed on how to intervene to increase standing in older Latinas.
OBJECTIVE


To describe the protocol for a randomized controlled trial to increase standing in postmenopausal Latinas: the Arriba por la Vida Estudio (AVE).
DESIGN/METHODS


Postmenopausal Latinas will be randomized to one of two study arms: an increase standing intervention or a heart healthy attention-comparison condition. A total of 250 overweight postmenopausal Latinas will be recruited and followed for 12weeks. AVE is based on various models of behavior change including strategies such as self-monitoring, goal setting, and habit formation. Participants will receive three in-personhealth-counseling sessions (including one in-home visit) and five follow-up telephone calls using motivational interviewing techniques. Those in the attention-comparison condition will receive an equal number of contacts as the standing intervention with topics focused on healthy aging. The primary outcome is objectively-measured sitting time over three months measured via thigh-worn inclinometers and secondary outcomes include blood pressure, physical functioning and glucoregulatory and lipid biomarkers.
CONCLUSIONS


The findings from this study will provide valuable information about effective approaches to increase standing time in postmenopausal Latinas and its impact on cardiovascular disease risk.
TRIAL REGISTRATION


This study is registered at clincialtrials.gov Identifier: NCT02905929.",2019,Those in the attention-comparison condition will receive an equal number of contacts as the standing intervention with topics focused on healthy aging.,"['250 overweight postmenopausal Latinas', 'postmenopausal', 'Latinas', 'Postmenopausal Latinas', 'targeting postmenopausal Latinas']","['standing intervention', 'Arriba por la Vida Estudio (AVE', 'personhealth-counseling sessions (including one in-home visit) and five follow-up telephone calls using motivational interviewing techniques', 'standing intervention or a heart healthy attention-comparison condition']","['objectively-measured sitting time over three months measured via thigh-worn inclinometers and secondary outcomes include blood pressure, physical functioning and glucoregulatory and lipid biomarkers', 'cardiovascular risk']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}]","[{'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0005595', 'cui_str': 'Aves'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4082119', 'cui_str': 'Three months (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0039866', 'cui_str': 'Thigh'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",250.0,0.0718325,Those in the attention-comparison condition will receive an equal number of contacts as the standing intervention with topics focused on healthy aging.,"[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Takemoto', 'Affiliation': 'University of California, San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States of America. Electronic address: mitakemoto@eng.ucsd.edu.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Schechtman', 'Affiliation': 'University of Michigan Medical School, 1500 E Medical Center Drive, Ann Arbor, MI 48109, United States of America.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Villa', 'Affiliation': 'San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, United States of America.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Talavera', 'Affiliation': 'San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, United States of America.'}, {'ForeName': 'Dorothy D', 'Initials': 'DD', 'LastName': 'Sears', 'Affiliation': 'University of California, San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States of America; College of Health Solutions, Arizona State University, 445 N. 5th Street, Phoenix, AZ, 85004, United States of America.'}, {'ForeName': 'Loki', 'Initials': 'L', 'LastName': 'Natarajan', 'Affiliation': 'University of California, San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States of America.'}, {'ForeName': 'Neville', 'Initials': 'N', 'LastName': 'Owen', 'Affiliation': 'Baker Heart and Diabetes Institute, 75 Commercial Road, Melbourne, Victoria 3004, Australia.'}, {'ForeName': 'Dori E', 'Initials': 'DE', 'LastName': 'Rosenberg', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, 1730 Minor Ave Suite 1600, Seattle, WA 98101, United States of America.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dunstan', 'Affiliation': 'Baker Heart and Diabetes Institute, 75 Commercial Road, Melbourne, Victoria 3004, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Allison', 'Affiliation': 'University of California, San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States of America.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Kerr', 'Affiliation': 'University of California, San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.02.004']
1358,31707858,Corneal collagen cross-linking with and without simultaneous intrastromal corneal ring segment implantation: One-year pilot study.,"AIM


The aim of this study was to assess and compare the visual, refractive, and topographic outcomes of keratoconic eyes treated with corneal collagen cross-linking combined with and without same day intrastromal corneal ring segment over the first 12 months.
METHODS


This prospective randomized study analyzed 38 eyes of 30 consecutive keratoconus patients aged 26.21 ± 6.97 (range = 15-41) years. A total of 20 eyes were treated with collagen cross-linking alone, and 18 eyes underwent collagen cross-linking combined with simultaneous femtosecond laser-assisted intrastromal corneal ring segment. Visual acuity, manifest refraction, and corneal topography (using a rotating Scheimpflug topographer) were assessed and compared between the two groups at baseline, 6, and 12 months.
RESULTS


On an average follow-up duration of 12.2 ± 0.50 (range = 11-13) months, both collagen cross-linking alone and collagen cross-linking with simultaneous intrastromal corneal ring segment implantation were effective. However, collagen cross-linking plus intrastromal corneal ring segment resulted in an additional improvement of uncorrected distance visual acuity of 0.16 (95% confidence interval = 0.01 to 0.32) logarithm of the minimum angle of resolution units (p = 0.035), cylindrical power by 1.16 D (95% confidence interval = 0.25 to 2.06, p = 0.014), and spherical equivalent by 1.40 D (95% confidence interval = -2.71 to -0.08, p = 0.038) at 1 year. During the study period, no serious intraoperative or postoperative complications were noted in either group.
CONCLUSION


One-year follow-up results suggest that collagen cross-linking with simultaneously combined intrastromal corneal ring segment implantation could yield an additive visual and refractive outcome. The combined procedure is safe and merits consideration for the treatment of progressive keratoconus to achieve better visual rehabilitation.",2019,"During the study period, no serious intraoperative or postoperative complications were noted in either group.
","['38 eyes of 30 consecutive keratoconus patients aged 26.21\u2009±\u20096.97 (range = 15-41) years', '20 eyes']","['Corneal collagen cross-linking with and without simultaneous intrastromal corneal ring segment implantation', 'corneal collagen cross-linking combined with and without same day intrastromal corneal ring segment', 'collagen cross-linking alone, and 18 eyes underwent collagen cross-linking combined with simultaneous femtosecond laser-assisted intrastromal corneal ring segment']","['Visual acuity, manifest refraction, and corneal topography (using a rotating Scheimpflug topographer', 'serious intraoperative or postoperative complications', 'uncorrected distance visual acuity', 'visual, refractive, and topographic outcomes']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C1283144', 'cui_str': 'Intrastromal corneal ring segment'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}]","[{'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C1301318', 'cui_str': 'M-Manifest refraction'}, {'cui': 'C0524957', 'cui_str': 'Corneal Topography'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}]",30.0,0.106256,"During the study period, no serious intraoperative or postoperative complications were noted in either group.
","[{'ForeName': 'Indra Prasad', 'Initials': 'IP', 'LastName': 'Sharma', 'Affiliation': 'Department of Ophthalmology, JDW National Referral Hospital, Thimphu, Bhutan.'}, {'ForeName': 'Ramendra', 'Initials': 'R', 'LastName': 'Bakshi', 'Affiliation': 'Department of Cornea, Eye7 Chaudhary Eye Centre, New Delhi, India.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Chaudhry', 'Affiliation': 'Department of Optometry and Vision Science, Amity Medical School, Amity University, Haryana, India.'}]",European journal of ophthalmology,['10.1177/1120672119887874']
1359,30922152,Effects of Exercise Interventions on Habitual Physical Activity and Sedentary Behavior in Adolescents With Cerebral Palsy.,"PURPOSE


Exercise interventions have been shown to increase motor capacities in adolescents with cerebral palsy; however, how they affect habitual physical activity (HPA) and sedentary behavior is unclear. The main objective was to correlate changes in HPA with changes in mobility capacity following exercise interventions.
METHODS


A total of 54 participants (aged 12-20 y) with bilateral spastic cerebral palsy at Gross Motor Function Classification System (GMFCS) levels II and III received 4 months of group progressive resistance training or treadmill training. Mobility measurements and HPA (averaged over 96 h) were made before and after interventions.
RESULTS


Averaged baseline mobility and HPA measures and improvements in each after both interventions were positively correlated in all participants. Percentage of sedentary/awake time decreased 2%, with significant increases in HPA measures of step count (16%), walk time (14%), and upright time (9%). Mobility measures and HPA changes were quite similar between Gross Motor Function Classification System levels, but improvement in HPA after group progressive resistance training was greater than after treadmill training (12% vs 4%) and correlated with mobility improvement.
CONCLUSIONS


Mobility capacity improved after these interventions and was clearly associated with improved HPA. The group progressive resistance training intervention seems preferable to improve HPA, perhaps related to greater social interaction and motivation provided by group training.",2019,"Mobility measures and HPA changes were quite similar between Gross Motor Function Classification System levels, but improvement in HPA after group progressive resistance training was greater than after treadmill training (12% vs 4%) and correlated with mobility improvement.  ","['Adolescents With Cerebral Palsy', '54 participants (aged 12-20\xa0y) with bilateral spastic cerebral palsy at Gross Motor Function Classification System (GMFCS) levels II and III received 4 months of group', 'adolescents with cerebral palsy']","['Exercise Interventions', 'Exercise interventions', 'progressive resistance training intervention', 'progressive resistance training or treadmill training']","['HPA after group progressive resistance training', 'walk time', 'HPA measures of step count', 'Mobility capacity', 'upright time', 'Mobility measurements and HPA', 'motor capacities', 'mobility improvement', 'Habitual Physical Activity and Sedentary Behavior', 'Percentage of sedentary/awake time', 'Mobility measures and HPA changes', 'HPA']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3838784', 'cui_str': 'Bilateral spastic cerebral palsy'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions (observable entity)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0441926', 'cui_str': 'Level II (tumor staging)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]","[{'cui': 'C0966198', 'cui_str': ""P(1)-(6-hydroxymethylpterin)-P(4)-(5'-adenosyl)tetraphosphate""}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0234422', 'cui_str': 'Awake (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",54.0,0.0127144,"Mobility measures and HPA changes were quite similar between Gross Motor Function Classification System levels, but improvement in HPA after group progressive resistance training was greater than after treadmill training (12% vs 4%) and correlated with mobility improvement.  ","[{'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Bar-Haim', 'Affiliation': 'Ben-Gurion University of the Negev.'}, {'ForeName': 'Ronit', 'Initials': 'R', 'LastName': 'Aviram', 'Affiliation': 'Ben-Gurion University of the Negev.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Shkedy Rabani', 'Affiliation': 'Ben-Gurion University of the Negev.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Amro', 'Affiliation': 'Al-Quds University.'}, {'ForeName': 'Ibtisam', 'Initials': 'I', 'LastName': 'Nammourah', 'Affiliation': 'Cambridge Medical & Rehabilitation Center.'}, {'ForeName': 'Muhammed', 'Initials': 'M', 'LastName': 'Al-Jarrah', 'Affiliation': 'Jordan University of Science and Technology.'}, {'ForeName': 'Yoav', 'Initials': 'Y', 'LastName': 'Raanan', 'Affiliation': 'Ben-Gurion University of the Negev.'}, {'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Loeppky', 'Affiliation': 'VA Medical Center.'}, {'ForeName': 'Netta', 'Initials': 'N', 'LastName': 'Harries', 'Affiliation': 'Assaf Harofeh Medical Center.'}]",Pediatric exercise science,['10.1123/pes.2018-0254']
1360,30676213,"Benefits of a Pole Walking Program Offered by Community Organizations on Physical Fitness, Psychological Well-Being, and Cognitive Function Among Older Adults.","The authors examined the effects of a 12-week pole walking program on function and well-being in 123 older adults aged 60 years and older, recruited by community organizations. The results showed a significant improvement in the participants' upper and lower limb strength in the experimental groups compared with those in the control groups (p < .05) and a significant deterioration in the walking speed and grip strength in women in the control groups compared with those in the experimental groups (p < .05). Although not statistically significant, the results also showed a trend toward greater improvement in global cognitive function in the participants in the experimental groups (p = .076). These results suggest that a pole walking program provided in natural conditions can improve physical capabilities in older adults. Other studies are warranted to further explore the impact of pole walking programs on older adults offered in such conditions, especially their impact on cognitive functions.",2019,The results showed a significant improvement in the participants' upper and lower limb strength in the experimental groups compared with those in the control groups (p < .05) and a significant deterioration in the walking speed and grip strength in women in the control groups compared with those in the experimental groups (p < .05).,"['123 older adults aged 60 years and older, recruited by community organizations', 'Older Adults', 'older adults']","['pole walking program', 'Pole Walking Program']","['Physical Fitness, Psychological Well-Being, and Cognitive Function', ""participants' upper and lower limb strength"", 'walking speed and grip strength', 'global cognitive function', 'physical capabilities']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0220885', 'cui_str': 'organization'}]","[{'cui': 'C0337815', 'cui_str': 'Poles (ethnic group)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}]",123.0,0.0120595,The results showed a significant improvement in the participants' upper and lower limb strength in the experimental groups compared with those in the control groups (p < .05) and a significant deterioration in the walking speed and grip strength in women in the control groups compared with those in the experimental groups (p < .05).,"[{'ForeName': 'Baptiste', 'Initials': 'B', 'LastName': 'Fournier', 'Affiliation': ''}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Lussier', 'Affiliation': ''}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Bier', 'Affiliation': ''}, {'ForeName': 'Johanne', 'Initials': 'J', 'LastName': 'Filiatrault', 'Affiliation': ''}, {'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Parisien', 'Affiliation': ''}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Chagnon', 'Affiliation': ''}, {'ForeName': 'Marie-Ève', 'Initials': 'MÈ', 'LastName': 'Mathieu', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2018-0055']
1361,30063940,Varying Stimulation Parameters to Improve Cortical Plasticity Generated by VNS-tone Pairing.,"Pairing vagus nerve stimulation (VNS) with movements or sounds can direct robust plasticity in motor or auditory cortex, respectively. The degree of map plasticity is influenced by the intensity and pulse width of VNS, number of VNS-event pairings, and the interval between each pairing. It is likely that these parameters interact, influencing optimal implementation of VNS pairing protocols. We varied VNS intensity, number of stimulations, and inter-stimulation interval (ISI) to test for interactions among these parameters. Rats were implanted with a vagus nerve stimulating cuff and randomly assigned to one of three treatment groups to receive 20 days of VNS paired with a 9-kHz tone: (1) Fast VNS: 50 daily pairings of 400-µA VNS with a 30-s ISI; (2) Dispersed VNS: 50 daily pairings of 400-µA VNS with a 180-s ISI; and (3) Standard VNS: 300 daily pairings of 800-µA VNS with a 30-s ISI. Following 20 days of VNS-tone pairing, multi-unit recordings were conducted in primary auditory cortex (A1) and receptive field properties were analyzed. Increasing ISI (Dispersed VNS) did not lead to an enhancement of cortical plasticity. Reducing the current intensity and number of stimulations (Fast VNS) resulted in robust cortical plasticity, using 6 times fewer VNS pairings than the Standard protocol. These findings reveal an interaction between current intensity, stimulation number, and ISI and identify a novel VNS paradigm that is substantially more efficient than the previous standard paradigm.",2018,Increasing ISI (Dispersed VNS) did not lead to an enhancement of cortical plasticity.,[],"['Increasing ISI (Dispersed VNS', 'vagus nerve stimulating cuff', 'Pairing vagus nerve stimulation (VNS) with movements or sounds', 'VNS paired with a 9-kHz tone: (1) Fast VNS: 50 daily pairings of 400-µA VNS with a 30-s ISI; (2) Dispersed VNS: 50 daily pairings of 400-µA VNS with a 180-s ISI; and (3) Standard VNS: 300 daily pairings of 800-µA VNS with a 30-s ISI']","['Cortical Plasticity', 'current intensity and number of stimulations (Fast VNS', 'VNS intensity, number of stimulations, and inter-stimulation interval (ISI']",[],"[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C4545472', 'cui_str': 'Disperse (transformation)'}, {'cui': 'C0042276', 'cui_str': 'Cranial Nerve X'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0556965', 'cui_str': 'kilohertz'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}]","[{'cui': 'C0678558', 'cui_str': 'Plasticity'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",,0.0530153,Increasing ISI (Dispersed VNS) did not lead to an enhancement of cortical plasticity.,"[{'ForeName': 'Kristofer W', 'Initials': 'KW', 'LastName': 'Loerwald', 'Affiliation': 'Texas Biomedical Device Center, Richardson, TX 75080, United States.'}, {'ForeName': 'Elizabeth P', 'Initials': 'EP', 'LastName': 'Buell', 'Affiliation': 'The University of Texas at Dallas, School of Behavioral Brain Sciences, 800 West Campbell Road, GR 41, Richardson, TX 75080-3021, United States.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Borland', 'Affiliation': 'The University of Texas at Dallas, School of Behavioral Brain Sciences, 800 West Campbell Road, GR 41, Richardson, TX 75080-3021, United States.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Rennaker', 'Affiliation': 'Texas Biomedical Device Center, Richardson, TX 75080, United States; The University of Texas at Dallas, School of Behavioral Brain Sciences, 800 West Campbell Road, GR 41, Richardson, TX 75080-3021, United States; The University of Texas at Dallas, Erik Jonsson School of Engineering and Computer Science, BSB 11, Richardson, TX 75080, United States.'}, {'ForeName': 'Seth A', 'Initials': 'SA', 'LastName': 'Hays', 'Affiliation': 'Texas Biomedical Device Center, Richardson, TX 75080, United States; The University of Texas at Dallas, Erik Jonsson School of Engineering and Computer Science, BSB 11, Richardson, TX 75080, United States. Electronic address: sxh129730@utdallas.edu.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Kilgard', 'Affiliation': 'Texas Biomedical Device Center, Richardson, TX 75080, United States; The University of Texas at Dallas, School of Behavioral Brain Sciences, 800 West Campbell Road, GR 41, Richardson, TX 75080-3021, United States.'}]",Neuroscience,['10.1016/j.neuroscience.2018.07.038']
1362,30905495,"A randomized clinical trial comparing early active motion programs: Earlier hand function, TAM, and orthotic satisfaction with a relative motion extension program for zones V and VI extensor tendon repairs.","STUDY DESIGN


Randomized clinical trial with parallel groups.
INTRODUCTION


Early active mobilization programs are used after zones V and VI extensor tendon repairs; two programs used are relative motion extension (RME) orthosis and controlled active motion (CAM). Although no comparative studies exist, use of the RME orthosis has been reported to support earlier hand function.
PURPOSE OF THE STUDY


This randomized clinical trial investigated whether patients managed with an RME program would recover hand function earlier postoperatively than those managed with a CAM program.
METHODS


Forty-two participants with zones V-VI extensor tendon repairs were randomized into either a CAM or RME program. The Sollerman Hand Function Test (SHFT) was the primary outcome measure of hand function. Days to return to work, QuickDASH (Disabilities of Arm, Shoulder and Hand) questionnaire, total active motion (TAM), grip strength, and patient satisfaction were the secondary measures of outcome.
RESULTS


The RME group demonstrated better results at four weeks for the SHFT score (P = .0073; 95% CI: -10.9, -1.8), QuickDASH score (P = .05; 95% CI: -0.05, 19.5), and TAM (P = .008; 95% CI: -65.4, -10.6). Days to return to work were similar between groups (P = .77; 95% CI: -28.1, 36.1). RME participants were more satisfied with the orthosis (P < .0001; 95% CI: 3.5, 8.4). No tendon ruptures occurred.
DISCUSSION


Participants managed using an RME program, and RME finger orthosis demonstrated significantly better early hand function, TAM, and orthosis satisfaction than those managed by the CAM program using a static wrist-hand-finger orthosis. This is likely due to the less restrictive design of the RME orthosis.
CONCLUSIONS


The RME program supports safe earlier recovery of hand function and motion when compared to a CAM program following repair of zones V and VI extensor tendons.",2020,"RME participants were more satisfied with the orthosis (P < .0001; 95% CI: 3.5, 8.4).","['patients managed with an RME program would recover hand function earlier postoperatively than those managed with a CAM program', 'Forty-two participants with zones V-VI extensor tendon repairs']","['TAM, and orthotic satisfaction with a relative motion extension program', 'CAM or RME program', 'RME']","['SHFT score', 'QuickDASH (Disabilities of Arm, Shoulder and Hand) questionnaire, total active motion (TAM), grip strength, and patient satisfaction', 'QuickDASH score', 'early hand function, TAM, and orthosis satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0562230', 'cui_str': 'Hand functions (observable entity)'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0224849', 'cui_str': 'Structure of extensor tendon'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1997924', 'cui_str': 'Disability of arm'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0231481', 'cui_str': 'Active movement (observable entity)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0562230', 'cui_str': 'Hand functions (observable entity)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",42.0,0.0917648,"RME participants were more satisfied with the orthosis (P < .0001; 95% CI: 3.5, 8.4).","[{'ForeName': 'Shirley J F', 'Initials': 'SJF', 'LastName': 'Collocott', 'Affiliation': 'Department of Hand Therapy, Manukau SuperClinic, Counties Manukau Health, Auckland, New Zealand. Electronic address: collocotts@gmail.com.'}, {'ForeName': 'Edel', 'Initials': 'E', 'LastName': 'Kelly', 'Affiliation': 'School of Clinical Sciences, Faculty of Health and Environmental Sciences, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Foster', 'Affiliation': 'Department of Plastic, Reconstructive and Hand Surgery, Middlemore Hospital, Counties Manukau Health, Otahuhu, New Zealand.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Myhr', 'Affiliation': 'Department of Hand Therapy, Manukau SuperClinic, Counties Manukau Health, Auckland, New Zealand.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Department of Hand Therapy, Manukau SuperClinic, Counties Manukau Health, Auckland, New Zealand.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Ellis', 'Affiliation': 'Health and Rehabilitation Research Institute, School of Clinical Sciences, Faculty of Health and Environmental Sciences, Auckland University of Technology, Auckland, New Zealand.'}]",Journal of hand therapy : official journal of the American Society of Hand Therapists,['10.1016/j.jht.2018.10.003']
1363,31694682,Recruitment effort and costs from a multi-center randomized controlled trial for treating depression in type 2 diabetes.,"BACKGROUND


Participant recruitment for clinical trials is a significant challenge for the scientific research community. Federal funding agencies have made continuation of funding of clinical trials contingent on meeting recruitment targets. It is incumbent on investigators to carefully set study recruitment timelines and resource needs to meet those goals as required under current funding mechanisms. This paper highlights the cost, labor, and barriers to recruitment for Program ACTVE II, a successful multisite randomized controlled trial of behavioral treatments for depression in adults with type 2 diabetes, conducted in rural and urban settings in three states.
METHODS


Quantitative and qualitative data on recruitment were gathered from study staff throughout the study recruitment period and were used to calculate costs and effort. The study utilized two main approaches to recruitment: (1) relying on potential participants to see ads in the community and call a toll-free number; and (2) direct phone calls to potential participants by study staff.
RESULTS


Contact was attempted with 18,925 people to obtain the enrolled sample of 140. The cost of recruitment activities during the 4.5-year recruitment period totaled $190,056, an average cost of $1358 per enrolled participant. Qualitative evaluations identified multiple barriers to recruitment.
CONCLUSIONS


Recruitment for Program ACTIVE II exemplifies the magnitude of resources needed to reach recruitment targets in the current era. Continuous evaluation, flexibility, and adaptation are required on the part of investigators, community partners, and funding agencies to successfully reach high-risk populations in rural and urban areas.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03371940 . Registered on 13 December 2017.",2019,"The cost of recruitment activities during the 4.5-year recruitment period totaled $190,056, an average cost of $1358 per enrolled participant.","['adults with type 2 diabetes, conducted in rural and urban settings in three states', 'type 2 diabetes', '18,925 people to obtain the enrolled sample of 140']",['recruitment: (1) relying on potential participants to see ads in the community and call a toll-free number; and (2) direct phone calls to potential participants by study staff'],['cost of recruitment activities'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0034877', 'cui_str': 'Recruitment Activities'}]",,0.155647,"The cost of recruitment activities during the 4.5-year recruitment period totaled $190,056, an average cost of $1358 per enrolled participant.","[{'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Myers', 'Affiliation': 'Indiana University School of Medicine, Diabetes Translational Research Center, 410 W 10th St, Suite 3100, Indianapolis, IN, 46202, USA.'}, {'ForeName': 'Yegan', 'Initials': 'Y', 'LastName': 'Pillay', 'Affiliation': 'Patton College of Education, Ohio University, McCracken Hall 432M, Athens, OH, 45701, USA.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Guyton Hornsby', 'Affiliation': 'West Virginia University School of Medicine, PO Box 9227, 8316 HSS, Morgantown, WV, 26506, USA.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Shubrook', 'Affiliation': 'College of Osteopathic Medicine, Touro University California, 1310 Club Dr, Vallejo, CA, 94592, USA.'}, {'ForeName': 'Chandan', 'Initials': 'C', 'LastName': 'Saha', 'Affiliation': 'Indiana University School of Medicine, Diabetes Translational Research Center, 410 W 10th St, Suite 3100, Indianapolis, IN, 46202, USA.'}, {'ForeName': 'Kieren J', 'Initials': 'KJ', 'LastName': 'Mather', 'Affiliation': 'Indiana University School of Medicine, Diabetes Translational Research Center, 410 W 10th St, Suite 3100, Indianapolis, IN, 46202, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Fitzpatrick', 'Affiliation': 'West Virginia University School of Medicine, PO Box 9227, 8316 HSS, Morgantown, WV, 26506, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'de Groot', 'Affiliation': 'Indiana University School of Medicine, Diabetes Translational Research Center, 410 W 10th St, Suite 3100, Indianapolis, IN, 46202, USA. mdegroot@iu.edu.'}]",Trials,['10.1186/s13063-019-3712-x']
1364,30888982,A Randomized Controlled Trial to Assess the Effectiveness of Muscle Strengthening and Balancing Exercises on Chemotherapy-Induced Peripheral Neuropathic Pain and Quality of Life Among Cancer Patients.,"BACKGROUND


Chemotherapy-induced peripheral neuropathy (CIPN) is the presence of tingling, burning, itching, and unpleasant sensations in hands and feet due to nerve damage by chemotherapy. Exercise rehabilitation has potential to prevent or alleviate CIPN.
OBJECTIVE


The aim of this study was to assess the effectiveness of muscle strengthening and balancing exercises on CIPN pain and quality of life (QOL) among cancer patients.
METHODS


The randomized controlled trial included 45 cancer patients from a tertiary care hospital in India receiving chemotherapeutic drugs paclitaxel and carboplatin and found to have CIPN. Subjects were randomly allocated to exercise (n1 = 22) and usual care (n2 = 23) groups. The exercise group received home-based muscle strengthening and balancing exercise for 10 weeks. Data regarding demographic, clinical characteristics, CIPN, neuropathic pain, and QOL were collected by structured questionnaires Chemotherapy-Induced Peripheral Neuropathy Assessment Tool, nerve conduction velocity, Leeds Assessment of Neuropathic Symptoms and Signs pain scale, and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire.
RESULTS


The 2 groups were homogenous regarding demographic variables. In clinical characteristics, the exercise group had larger body surface area and received a higher dose of paclitaxel. Significant reduction in neuropathic pain scores (P < .0001) and improvement in Functional QOL (P = .0002), Symptom QOL (P = .0003), Global Health Status QOL (P = .004) scores were observed after intervention in the exercise group than the usual-care group.
CONCLUSION


Muscle strengthening and balancing exercises are effective in reducing CIPN pain and improving QOL among cancer patients.
IMPLICATIONS FOR PRACTICE


Muscle strengthening and balancing exercises can be used as a complementary therapy for effective management of CIPN.",2020,"Significant reduction in neuropathic pain scores (P < .0001) and improvement in Functional QOL (P = .0002), Symptom QOL (P = .0003), Global Health Status QOL (P = .004) scores were observed after intervention in the exercise group than the usual-care group.
","['Cancer Patients', 'cancer patients', '45 cancer patients from a tertiary care hospital in India receiving chemotherapeutic drugs paclitaxel and carboplatin and found to have CIPN']","['exercise group received home-based muscle strengthening and balancing exercise', 'Muscle Strengthening and Balancing Exercises', 'muscle strengthening and balancing exercises', 'paclitaxel', 'Exercise rehabilitation', 'Muscle strengthening and balancing exercises']","['Peripheral Neuropathic Pain and Quality of Life', 'CIPN pain and improving QOL', 'Global Health Status QOL', 'CIPN pain and quality of life (QOL', 'Neuropathic Symptoms and Signs pain scale, and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire', 'demographic, clinical characteristics, CIPN, neuropathic pain, and QOL', 'Symptom QOL', 'neuropathic pain scores', 'Functional QOL']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0458960', 'cui_str': 'Peripheral neuropathic pain (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0451149', 'cui_str': 'EORTC - Quality of life questionnaire'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0027796', 'cui_str': 'Neurodynia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",45.0,0.0642622,"Significant reduction in neuropathic pain scores (P < .0001) and improvement in Functional QOL (P = .0002), Symptom QOL (P = .0003), Global Health Status QOL (P = .004) scores were observed after intervention in the exercise group than the usual-care group.
","[{'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Dhawan', 'Affiliation': ""Author Affiliations: Institute of Nursing, King George's Medical University, Lucknow (Ms Dhawan); and College of Nursing (Dr Andrews) and Departments of Medical Oncology (Dr Kumar), Physical Medicine and Rehabilitation (Dr Wadhwa), and Neurology (Dr Shukla), All India Institute of Medical Sciences, New Delhi, India.""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Andrews', 'Affiliation': ''}, {'ForeName': 'Lalit', 'Initials': 'L', 'LastName': 'Kumar', 'Affiliation': ''}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Wadhwa', 'Affiliation': ''}, {'ForeName': 'Garima', 'Initials': 'G', 'LastName': 'Shukla', 'Affiliation': ''}]",Cancer nursing,['10.1097/NCC.0000000000000693']
1365,30821349,Dexmedetomidine versus propofol at different sedation depths during drug-induced sleep endoscopy: A randomized trial.,"OBJECTIVES/HYPOTHESIS


The aim of this study was to compare the effect of dexmedetomidine and propofol on airway dynamics, cardiorespiratory system, and emergence following drug-induced sleep endoscopy (DISE).
STUDY DESIGN


Prospective, randomized, single-blinded study.
METHODS


Sixty patients age 18 to 65 years in American Society of Anesthesiologists physical status groups 1 and 2 scheduled to undergo DISE were randomly allocated to either Group P (N = 30; receiving propofol infusion at 50-150 μg/kg/min) or Group D (N = 30; receiving dexmedetomidine bolus of 1 μg/kg followed by infusion at 0.5-1.0 μg/kg/hr). DISE was done at light sleep and deep sleep. Airway obstruction at tongue base was recorded as primary outcome. Airway obstruction at velum, oropharyngeal lateral wall, and epiglottis level during light and deep sedation, hemodynamic and respiratory parameters, time to attain sufficient sedation, time for emergence from sedation, and any adverse events during DISE with the two study drugs were recorded as secondary outcomes.
RESULTS


There was a greater degree of obstruction at the tongue base level (P = 0.001) and Oropharynx level (P = 0.017) in Group P compared with Group D during deep sedation. Increase in airway obstruction from light to deep sleep was seen with propofol at the oropharynx (P = 0.0185) and tongue base (P = 0.0108) levels. Two patients (6.6%) in Group D and 10 patients (33.3%) in Group P showed oxygen saturation below the minimum oxygen saturation recorded during polysomnography. Time to open eyes to call after stopping sedation was significantly less in Group P (P = 0.005).
CONCLUSIONS


Dexmedetomidine shows a lesser degree of airway collapse and higher oxygen saturation levels at greater sedation depth during DISE. Propofol has a faster onset and emergence from sedation.
LEVEL OF EVIDENCE


1b Laryngoscope, 130:257-262, 2020.",2020,"Time to open eyes to call after stopping sedation was significantly less in Group P (P = 0.005).
","['Sixty patients age 18 to 65\u2009years in American Society of Anesthesiologists physical status groups 1 and 2 scheduled to undergo DISE', 'drug-induced sleep endoscopy']","['Dexmedetomidine', 'DISE', 'propofol', 'propofol infusion', 'dexmedetomidine and propofol', 'dexmedetomidine', 'Propofol']","['Oropharynx level', 'degree of airway collapse and higher oxygen saturation levels', 'oxygen saturation below the minimum oxygen saturation', 'Airway obstruction at velum, oropharyngeal lateral wall, and epiglottis level during light and deep sedation, hemodynamic and respiratory parameters, time to attain sufficient sedation, time for emergence from sedation, and any adverse events', 'degree of obstruction', 'airway obstruction from light to deep sleep', 'airway dynamics, cardiorespiratory system, and emergence following drug-induced sleep endoscopy (DISE']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0458082', 'cui_str': 'Drug-induced (qualifier value)'}, {'cui': 'C0396283', 'cui_str': 'Sleep nasendoscopy (procedure)'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0521367', 'cui_str': 'Oropharynxs'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0392748', 'cui_str': 'Collapsed (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0001883', 'cui_str': 'Airway Obstruction'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0014540', 'cui_str': 'Epiglottic Cartilage'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C1956064', 'cui_str': 'Deep Sedation'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205410', 'cui_str': 'Sufficient (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0234451', 'cui_str': 'Sleep, Slow-Wave'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0458082', 'cui_str': 'Drug-induced (qualifier value)'}, {'cui': 'C0396283', 'cui_str': 'Sleep nasendoscopy (procedure)'}]",60.0,0.101284,"Time to open eyes to call after stopping sedation was significantly less in Group P (P = 0.005).
","[{'ForeName': 'Tonsy V', 'Initials': 'TV', 'LastName': 'Padiyara', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Bansal', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Jain', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Arora', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Komal', 'Initials': 'K', 'LastName': 'Gandhi', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}]",The Laryngoscope,['10.1002/lary.27903']
1366,27808528,Avoidant coping and diabetes-related distress: Pathways to adolescents' Type 1 diabetes outcomes.,"OBJECTIVE


Adolescents with Type 1 diabetes (T1D) are vulnerable to diabetes-related distress and often struggle to complete self-management tasks needed to maintain blood glucose values in target range. One way that youth with T1D handle problems is through avoidant coping. The current study examined cross-time associations between avoidant coping style and diabetes outcomes and tested the possible mediating role of diabetes-related distress.
METHOD


Adolescents with T1D (N = 264) were assessed 4 times over 1 year to measure avoidant coping style, diabetes-related distress, adherence (on the basis of glucometer data and self-report), and glycemic control (hemoglobin A1c). Mediation and direct effects were tested across time using time-lagged autoregressive path models, making use of the repeated measurement of all constructs.
RESULTS


The hypothesized mediation effect was found for all 3 diabetes outcomes. Higher levels of avoidant coping style were associated with greater diabetes-related distress at the subsequent time point, which was related in turn to fewer blood glucose checks, less frequent self-care behaviors, and poorer glycemic control (higher A1c) at the next assessment.
CONCLUSIONS


In the context of diabetes, an avoidant coping style may contribute to greater diabetes-specific distress followed by deterioration in self-management and glycemic control over time. Maladaptive coping styles are modifiable factors that offer an entry point into intervention before further difficulties can take hold. (PsycINFO Database Record",2017,"Higher levels of avoidant coping style were associated with greater diabetes-related distress at the subsequent time point, which was related in turn to fewer blood glucose checks, less frequent self-care behaviors, and poorer glycemic control (higher A1c) at the next assessment.
","['Adolescents with T1D (N = 264', 'Adolescents with Type 1 diabetes (T1D']",[],"['Higher levels of avoidant coping style', 'Avoidant coping and diabetes-related distress', 'blood glucose checks, less frequent self-care behaviors, and poorer glycemic control', 'avoidant coping style, diabetes-related distress, adherence (on the basis of glucometer data and self-report), and glycemic control (hemoglobin A1c']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior (finding)'}, {'cui': 'C0342299', 'cui_str': 'Poor glycemic control (disorder)'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}]",264.0,0.0137314,"Higher levels of avoidant coping style were associated with greater diabetes-related distress at the subsequent time point, which was related in turn to fewer blood glucose checks, less frequent self-care behaviors, and poorer glycemic control (higher A1c) at the next assessment.
","[{'ForeName': 'Esti', 'Initials': 'E', 'LastName': 'Iturralde', 'Affiliation': 'Department of Pediatrics, Stanford University School of Medicine.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Weissberg-Benchell', 'Affiliation': ""Northwestern University Feinberg School of Medicine/Ann and Robert H. Lurie Children's Hospital of Chicago.""}, {'ForeName': 'Korey K', 'Initials': 'KK', 'LastName': 'Hood', 'Affiliation': 'Department of Pediatrics, Stanford University School of Medicine.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000445']
1367,29952302,A randomized comparison of combined itraconazole and Nd:YAG 1064-nm laser vs itraconazole alone for the treatment of cutaneous sporotrichosis.,,2018,,['cutaneous sporotrichosis'],['combined itraconazole and Nd:YAG 1064-nm laser vs itraconazole alone'],[],"[{'cui': 'C0276726', 'cui_str': 'Cutaneous sporotrichosis (disorder)'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}]",[],,0.0189051,,"[{'ForeName': 'Jinran', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'China-Japan Union Hospital of Jilin University, 126 Xiantai St, Erdao, Changchun, Jilin 130033, China.'}, {'ForeName': 'Mingji', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': 'China-Japan Union Hospital of Jilin University, 126 Xiantai St, Erdao, Changchun, Jilin 130033, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'China-Japan Union Hospital of Jilin University, 126 Xiantai St, Erdao, Changchun, Jilin 130033, China.'}, {'ForeName': 'Jinlan', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'China-Japan Union Hospital of Jilin University, 126 Xiantai St, Erdao, Changchun, Jilin 130033, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'China-Japan Union Hospital of Jilin University, 126 Xiantai St, Erdao, Changchun, Jilin 130033, China.'}, {'ForeName': 'Rihua', 'Initials': 'R', 'LastName': 'Jiang', 'Affiliation': 'China-Japan Union Hospital of Jilin University, 126 Xiantai St, Erdao, Changchun, Jilin 130033, China.'}, {'ForeName': 'Yuxi', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'China-Japan Union Hospital of Jilin University, 126 Xiantai St, Erdao, Changchun, Jilin 130033, China.'}]",European journal of dermatology : EJD,['10.1684/ejd.2018.3343']
1368,31520309,Comparison of Therapeutic Efficacy of Ferrous Ascorbate and Iron Polymaltose Complex in Iron Deficiency Anemia in Children: A Randomized Controlled Trial.,"OBJECTIVE


To compare the therapeutic efficacy of Ferrous ascorbate (FA) and Iron polymaltose complex (IPC) in Iron deficiency anemia (IDA) in children.
METHODS


A randomized controlled trial (RCT) was conducted at a tertiary care hospital with 125 (1-12 y) children having clinical symptoms and signs of IDA. Participants were randomized into FA group and IPC group. Both the groups received iron salts (FA or IPC) randomly in a dose of 6 mg/kg elemental iron for 3 mo and followed up on day 3, day 7, at the end of 1 mo and 3 mo for Hemoglobin (Hb), Mean corpuscular volume (MCV), Red cell distribution width (RDW) and reticulocyte count.
RESULTS


Both groups had an improvement in hematological parameters at 3 mo of intervention. The difference in the rise of Hb (g%) at the end of 1 mo in FA group (3.13 ± 1.01) vs. IPC group (2.0 ± 0.85); p = 0.017 and at 3 mo in FA group (4.88 ± 1.28) vs. IPC group (3.33 ± 1.33); p = 0.001 was statistically significant. The difference in the rise of mean Hb was significantly better in FA than the IPC group F [3392] =1.79; p = 0.00 (ANOVA). The difference in the mean increase in MCV (fL) at day 7 in FA group (6.71 ± 8.32) vs. IPC group (2.91 ± 6.16); p = 0.011 and at 1 mo FA group (9.80 ± 8.56) vs. IPC group (5.35 ± 6.11); p = 0.004 was statistically significant. The mean decrease in RDW (%) at 1 mo in FA group (4.23 ± 3.27) vs. IPC group (2.67 ± 1.95); p = 0.005 and at 3 mo in FA group (5.74 ± 3.63) vs. IPC group (4.04 ± 2.17); p = 0.006 was statistically significant. The difference in the rise in mean reticulocyte count at day 3 in FA group (0.88 ± 0.50) vs. IPC group (0.43 ± 1.20); p = 0.017 and at day 7 in FA group (4.00 ± 1.69) vs. IPC group (2.19 ± 1.24); p = 0.001 was statistically significant. F [2294] = 29.2, p = 0.00 (ANOVA). During the study period, the FA group had minor adverse reactions whereas the IPC group had none.
CONCLUSIONS


Both the iron salts (FA and IPC) used in the treatment of IDA showed statistically significant improvement in the hematological parameters during the 3 mo of intervention. The improvement in hematological parameters was better in FA supplemented patients as compared to IPC.",2019,Both the iron salts (FA and IPC) used in the treatment of IDA showed statistically significant improvement in the hematological parameters during the 3 mo of intervention.,"['tertiary care hospital with 125 (1-12 y) children having clinical symptoms and signs of IDA', 'Iron deficiency anemia (IDA) in children', 'Children']","['Ferrous ascorbate (FA) and Iron polymaltose complex (IPC', 'FA group and IPC', 'Ferrous Ascorbate and Iron Polymaltose Complex', 'iron salts (FA or IPC', 'iron salts (FA and IPC']","['mean increase in MCV (fL', 'mean reticulocyte count', 'hematological parameters', 'rise of mean Hb', 'Mean corpuscular volume (MCV), Red cell distribution width (RDW) and reticulocyte count', 'rise of Hb (g', 'mean decrease in RDW', 'adverse reactions']","[{'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia (disorder)'}]","[{'cui': 'C0015888', 'cui_str': 'Ferrous Ascorbate'}, {'cui': 'C0076040', 'cui_str': 'iron polymaltose'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0302206', 'cui_str': 'Iron salt (substance)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1961129', 'cui_str': 'Microvolt'}, {'cui': 'C0206161', 'cui_str': 'Reticulocyte Number'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0863148', 'cui_str': 'Erythrocyte mean corpuscular volume determination (procedure)'}, {'cui': 'C0427460', 'cui_str': 'Red Cell Distribution Width'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}]",,0.0376988,Both the iron salts (FA and IPC) used in the treatment of IDA showed statistically significant improvement in the hematological parameters during the 3 mo of intervention.,"[{'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Patil', 'Affiliation': 'Department of Pediatrics, GMCH Aurangabad, Panchakki Jubliee Park, Aurangabad, Maharashtra, 431001, India.'}, {'ForeName': 'Prajit', 'Initials': 'P', 'LastName': 'Geevarghese', 'Affiliation': 'Department of Pediatrics, GMCH Aurangabad, Panchakki Jubliee Park, Aurangabad, Maharashtra, 431001, India. prajeeth200@gmail.com.'}, {'ForeName': 'Prabha', 'Initials': 'P', 'LastName': 'Khaire', 'Affiliation': 'Department of Pediatrics, GMCH Aurangabad, Panchakki Jubliee Park, Aurangabad, Maharashtra, 431001, India.'}, {'ForeName': 'Trupti', 'Initials': 'T', 'LastName': 'Joshi', 'Affiliation': 'Department of Pediatrics, GMCH Aurangabad, Panchakki Jubliee Park, Aurangabad, Maharashtra, 431001, India.'}, {'ForeName': 'Amol', 'Initials': 'A', 'LastName': 'Suryawanshi', 'Affiliation': 'Department of Pediatrics, GMCH Aurangabad, Panchakki Jubliee Park, Aurangabad, Maharashtra, 431001, India.'}, {'ForeName': 'Smita', 'Initials': 'S', 'LastName': 'Mundada', 'Affiliation': 'Department of Pediatrics, GMCH Aurangabad, Panchakki Jubliee Park, Aurangabad, Maharashtra, 431001, India.'}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Pawar', 'Affiliation': 'Department of Pediatrics, GMCH Aurangabad, Panchakki Jubliee Park, Aurangabad, Maharashtra, 431001, India.'}, {'ForeName': 'Aziz', 'Initials': 'A', 'LastName': 'Farookh', 'Affiliation': 'Department of Pediatrics, GMCH Aurangabad, Panchakki Jubliee Park, Aurangabad, Maharashtra, 431001, India.'}]",Indian journal of pediatrics,['10.1007/s12098-019-03068-2']
1369,29490560,Moderate Physical Activity in an Aquatic Environment During Pregnancy (SWEP Study) and Its Influence in Preventing Postpartum Depression.,"INTRODUCTION


Postpartum depression (PPD) can begin within 6 weeks postpartum (International Classification of Diseases, 10th Revision) and represents a significant health problem for mothers.
AIM


To determine whether physical activity during pregnancy alleviates PPD.
METHOD


Randomized controlled trial in which the exercise group practiced moderate physical exercise in an aquatic environment (1-hour sessions, 3 days a week), following the recommendations of the SWEP method.
RESULTS


The results observed in the Edinburgh Postnatal Depression Scale were significant between the exercise group and the control group ( p < .001). In addition, significant differences were observed according in body mass index between the exercise group and control group in the overweight and obesity categories ( p < .05).
CONCLUSION


Women who perform moderate physical exercise in an aquatic environment are at lower risk of PPD than sedentary women. Overweight and obesity among sedentary women during pregnancy are closely associated with positive screening for PPD.",2019,The results observed in the Edinburgh Postnatal Depression Scale were significant between the exercise group and the control group ( p < .001).,[],"['exercise group practiced moderate physical exercise', 'moderate physical exercise']","['Overweight and obesity', 'Edinburgh Postnatal Depression Scale', 'body mass index', 'physical activity', 'Moderate Physical Activity']",[],"[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0018262', 'cui_str': 'Group Practice'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh Postnatal Depression Scale'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]",,0.0452859,The results observed in the Edinburgh Postnatal Depression Scale were significant between the exercise group and the control group ( p < .001).,"[{'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Aguilar-Cordero', 'Affiliation': '1 María José Aguilar-Cordero, PhD, University of Granada, San Cecilio Clinical Hospital, Granada, Spain.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Sánchez-García', 'Affiliation': '2 Juan Carlos Sánchez-García, PhD, University of Granada, Granada, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Rodriguez-Blanque', 'Affiliation': '3 Raquel Rodriguez-Blanque, PhD, University of Granada, Granada, Spain.'}, {'ForeName': 'Antonio Manuel', 'Initials': 'AM', 'LastName': 'Sánchez-López', 'Affiliation': '4 Antonio Manuel Sánchez-López, PhD, University of Granada, Granada, Spain.'}, {'ForeName': 'Norma', 'Initials': 'N', 'LastName': 'Mur-Villar', 'Affiliation': '5 Norma Mur-Villar, PhD, University of Granada, Granada, Spain; Cienfuegos School of Medical Sciences, Cienfuegos, Cuba.'}]",Journal of the American Psychiatric Nurses Association,['10.1177/1078390317753675']
1370,30571288,Molecular adaptations in human subcutaneous adipose tissue after ten weeks of endurance exercise training in healthy males.,"Endurance exercise training induces adaptations in metabolically active organs, but adaptations in human subcutaneous adipose tissue (scAT) remains incompletely understood. On the basis of animal studies, we hypothesized that endurance exercise training would increase the expression of proteins involved in lipolysis and glucose uptake in scAT. To test these hypotheses, 19 young and healthy males were randomized to either endurance exercise training (TR; age 18-24 yr; BMI 19.0-25.4 kg/m 2 ) or a nonexercising control group (CON; age 21-35 yr; BMI 20.5-28.8 kg/m 2 ). Abdominal subcutaneous fat biopsies and blood were obtained at rest before and after intervention. By using Western blotting and PCR, we determined expression of lipid droplet-associated proteins, various proteins involved in substrate metabolism, and mRNA abundance of cell surface G protein-coupled receptors (GPCRs). Adipose tissue insulin sensitivity was determined from fasting plasma insulin and nonesterified fatty acids (adipose tissue insulin resistance index; Adipo-IR). Adipo-IR improved in TR compared with CON ( P = 0.03). This was accompanied by increased insulin receptor (IR) protein expression in scAT with a 1.54-fold (SD 0.79) change from baseline in TR vs. 0.85 (SD 0.30) in CON ( P = 0.007). Additionally, hexokinase II (HKII) and succinate dehydrogenase complex subunit A (SDHA) protein increased in TR compared with CON ( P = 0.006 and P = 0.04, respectively). We did not observe changes in lipid droplet-associated proteins or mRNA abundance of GPCRs. Collectively, 10 weeks of endurance exercise training improved adipose tissue insulin sensitivity, which was accompanied by increased IR, HKII, and SDHA protein expression in scAT. We suggest that these adaptations contribute to an improved metabolic flexibility. NEW & NOTEWORTHY This study is the first to investigate the molecular adaptations in human subcutaneous adipose tissue (scAT) after endurance exercise training compared with a nonexercising control group. We show that endurance exercise training improves insulin sensitivity in human scAT, and this is accompanied by increased expression of insulin receptor, hexokinase II, and succinate dehydrogenase complex subunit A. Collectively, our data suggest that endurance exercise training induces molecular adaptations in human scAT, which may contribute to an improved metabolic flexibility.",2019,Adipo-IR improved in TR compared with CON ( P = 0.03).,"['19 young and healthy males', 'healthy males']","['Endurance exercise training', 'nonexercising control', 'endurance exercise training']","['insulin sensitivity', 'Adipose tissue insulin sensitivity', 'Adipo-IR improved in TR', 'insulin receptor (IR) protein expression', 'fasting plasma insulin and nonesterified fatty acids (adipose tissue insulin resistance index; Adipo-IR', 'IR, HKII, and SDHA protein expression', 'metabolic flexibility', 'hexokinase II (HKII) and succinate dehydrogenase complex subunit A (SDHA) protein increased in TR', 'expression of proteins involved in lipolysis and glucose uptake', 'adipose tissue insulin sensitivity']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise (regime/therapy)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0034818', 'cui_str': 'Insulin Receptor'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0019475', 'cui_str': 'Hexokinase II'}, {'cui': 'C0038615', 'cui_str': 'Succinic Dehydrogenase'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0023796', 'cui_str': 'Lipolysis'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]",,0.0177905,Adipo-IR improved in TR compared with CON ( P = 0.03).,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Riis', 'Affiliation': 'Section for Sport Science, Department of Public Health, Aarhus University , Aarhus , Denmark.'}, {'ForeName': 'Britt', 'Initials': 'B', 'LastName': 'Christensen', 'Affiliation': 'Section for Sport Science, Department of Public Health, Aarhus University , Aarhus , Denmark.'}, {'ForeName': 'Birgitte', 'Initials': 'B', 'LastName': 'Nellemann', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital , Aarhus , Denmark.'}, {'ForeName': 'Andreas Buch', 'Initials': 'AB', 'LastName': 'Møller', 'Affiliation': 'Research Laboratory for Biochemical Pathology, Department of Clinical Medicine, Aarhus University , Aarhus , Denmark.'}, {'ForeName': 'Anna Sofie', 'Initials': 'AS', 'LastName': 'Husted', 'Affiliation': 'Section for Metabolic Receptology, Novo Nordisk Foundation Center for Basic Metabolic Research , Copenhagen , Denmark.'}, {'ForeName': 'Steen B', 'Initials': 'SB', 'LastName': 'Pedersen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital , Aarhus , Denmark.'}, {'ForeName': 'Thue W', 'Initials': 'TW', 'LastName': 'Schwartz', 'Affiliation': 'Section for Metabolic Receptology, Novo Nordisk Foundation Center for Basic Metabolic Research , Copenhagen , Denmark.'}, {'ForeName': 'Jens Otto Lunde', 'Initials': 'JOL', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital , Aarhus , Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Jessen', 'Affiliation': 'Research Laboratory for Biochemical Pathology, Department of Clinical Medicine, Aarhus University , Aarhus , Denmark.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00989.2018']
1371,30849931,Acute Effects of Interrupting Prolonged Sitting With Intermittent Physical Activity on Blood Pressure in Preadolescent Children.,"PURPOSE


To compare the acute effects of intermittent physical activity (PA) across 4 different intensities on blood pressure.
METHODS


Thirty children (12 males and 18 females; aged 7-11 y; 33% overweight/obese; 53% nonwhite) completed 4 experimental conditions in random order: 8 hours sitting interrupted with 20, 2-minute low-, moderate-, high-intensity PA breaks, or sedentary screen-time breaks. PA intensity corresponded with 25%, 50%, and 75% of heart rate reserve. Blood pressure was measured during each condition in the morning (0800 h), noon (1200 h), and afternoon (1600 h).
RESULTS


There were no significant differences across conditions for systolic blood pressure (SBP; all Ps > .05). There was a significant effect of time with SBP decreasing throughout the day for all conditions (average morning SBP: 106 [1] mm Hg, average noon SBP: 101 [2] mm Hg, average afternoon SBP: 103 [1] mm Hg; P = .01). There were no significant effects of condition or time on diastolic blood pressure (all Ps > .05).
CONCLUSION


While sedentary behavior is known to be associated with hypertension in both adults and children, a single bout of prolonged sitting may be insufficient to produce hypertensive effects in otherwise healthy children. Future research should examine the appropriate dose of intermittent PA to accrue hypotensive responses in preadolescent children.",2019,There were no significant differences across conditions for systolic blood pressure (SBP; all Ps > .05).,"['preadolescent children', 'aged 7-11\xa0y; 33% overweight/obese; 53% nonwhite) completed 4 experimental conditions in random order: 8', 'Thirty children (12 males and 18 females', 'Preadolescent Children']","['intermittent physical activity (PA', 'hours sitting interrupted with 20, 2-minute low-, moderate-, high-intensity PA breaks, or sedentary screen-time breaks', 'Prolonged Sitting With Intermittent Physical Activity']","['PA intensity', 'time with SBP', 'Blood Pressure', 'condition or time on diastolic blood pressure', 'systolic blood pressure', 'Blood pressure']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0443239', 'cui_str': 'Interrupted (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",30.0,0.0442614,There were no significant differences across conditions for systolic blood pressure (SBP; all Ps > .05).,"[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Weston', 'Affiliation': 'University of Michigan.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Nagy', 'Affiliation': 'University of Michigan.'}, {'ForeName': 'Tiwaloluwa A', 'Initials': 'TA', 'LastName': 'Ajibewa', 'Affiliation': 'University of Michigan.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': ""O'Sullivan"", 'Affiliation': 'University of Michigan.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Block', 'Affiliation': 'University of Michigan.'}, {'ForeName': 'Rebecca E', 'Initials': 'RE', 'LastName': 'Hasson', 'Affiliation': 'University of Michigan.'}]",Pediatric exercise science,['10.1123/pes.2018-0224']
1372,30840903,"The Kawasaki Disease Comparative Effectiveness (KIDCARE) trial: A phase III, randomized trial of second intravenous immunoglobulin versus infliximab for resistant Kawasaki disease.","BACKGROUND


Although intravenous immunoglobulin (IVIG) is effective therapy for Kawasaki disease (KD), the most common cause of acquired heart disease in children, 10-20% of patients are IVIG-resistant and require additional therapy. This group has an increased risk of coronary artery aneurysms (CAA) and there has been no adequately powered, randomized clinical trial in a multi-ethnic population to determine the optimal therapy for IVIG-resistant patients.
OBJECTIVES


The primary outcome is duration of fever in IVIG-resistant patients randomized to treatment with either infliximab or a second IVIG infusion. Secondary outcomes include comparison of inflammatory markers, duration of hospitalization, and coronary artery outcome. An exploratory aim records parent-reported outcomes including signs, symptoms and treatment experience.
METHODS


The KIDCARE trial is a 30-site randomized Phase III comparative effectiveness trial in KD patients with fever ≥36 h after the completion of their first IVIG treatment. Eligible patients will be randomized to receive either a second dose of IVIG (2 g/kg) or infliximab (10 mg/kg). Subjects with persistent or recrudescent fever at 24 h following completion of the first study treatment will cross-over to the other treatment arm. Subjects will exit the study after their first outpatient visit (5-18 days following last study treatment). The parent-reported outcomes, collected daily during hospitalization and at home, will be compared by study arm.
CONCLUSION


This trial will contribute to the management of IVIG-resistant patients by establishing the relative efficacy of a second dose of IVIG compared to infliximab and will provide data regarding the patient/parent experience of these treatments.",2019,The KIDCARE trial is a 30-site randomized Phase III comparative effectiveness trial in KD patients with fever ≥36 h after the completion of their first IVIG treatment.,"['Kawasaki disease (KD', 'KD patients with fever ≥36\u202fh after the completion of their first IVIG treatment', 'Subjects with persistent or recrudescent fever at 24\u202fh', 'Eligible patients', 'resistant Kawasaki disease']","['immunoglobulin versus infliximab', 'infliximab', 'intravenous immunoglobulin (IVIG', 'IVIG']","['risk of coronary artery aneurysms (CAA', 'comparison of inflammatory markers, duration of hospitalization, and coronary artery outcome', 'duration of fever']","[{'cui': 'C0026691', 'cui_str': 'Kawasaki Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}]","[{'cui': 'C0021027', 'cui_str': 'Immune Globulins'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0010051', 'cui_str': 'Coronary Aneurysm'}, {'cui': 'C1842937', 'cui_str': 'Caa'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}]",,0.14672,The KIDCARE trial is a 30-site randomized Phase III comparative effectiveness trial in KD patients with fever ≥36 h after the completion of their first IVIG treatment.,"[{'ForeName': 'Samantha C', 'Initials': 'SC', 'LastName': 'Roberts', 'Affiliation': ""Rady Children's Hospital, 7910 Frost St Suite 300, San Diego, CA, 92123, United States. Electronic address: sroberts@ucsd.edu.""}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'University of California San Diego, 9500 Gilman Dr., La Jolla, CA, 92093, United States. Electronic address: sojain@ucsd.edu.'}, {'ForeName': 'Adriana H', 'Initials': 'AH', 'LastName': 'Tremoulet', 'Affiliation': 'University of California San Diego, 9500 Gilman Dr., La Jolla, CA, 92093, United States; University of California Davis, Betty Irene Moore School of Nursing, 2450 48th Street, Sacramento, CA 95817, United States. Electronic address: atremoulet@ucsd.edu.'}, {'ForeName': 'Katherine K', 'Initials': 'KK', 'LastName': 'Kim', 'Affiliation': 'University of California Davis, Betty Irene Moore School of Nursing, 2450 48th Street, Sacramento, CA 95817, United States. Electronic address: kathykim@ucdavis.edu.'}, {'ForeName': 'Jane C', 'Initials': 'JC', 'LastName': 'Burns', 'Affiliation': ""Rady Children's Hospital, 7910 Frost St Suite 300, San Diego, CA, 92123, United States; University of California San Diego, 9500 Gilman Dr., La Jolla, CA, 92093, United States. Electronic address: jcburns@ucsd.edu.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Anand', 'Affiliation': 'Cedars-Sinai Medical Center, 8700 Beverly Blvd, West Hollywood, CA, 90048, United States.'}, {'ForeName': 'Marsha', 'Initials': 'M', 'LastName': 'Anderson', 'Affiliation': ""Children's Hospital Colorado, 13123 East 16th Avenue, B100, Aurora, CO, 80045, United States.""}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Ang', 'Affiliation': ""Children's Hospital of Michigan, Wayne State University School of Medicine, 540 E Canfield St, Detroit, MI, 48201, United States.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Ansusinha', 'Affiliation': ""Children's National Health System, 111 Michigan Ave NW, Washington, DC, 20010, United States of America.""}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Arditi', 'Affiliation': 'Cedars-Sinai Medical Center, 8700 Beverly Blvd, West Hollywood, CA, 90048, United States of America.'}, {'ForeName': 'Negar', 'Initials': 'N', 'LastName': 'Ashouri', 'Affiliation': ""Children's Hospital of Orange County, 1201 W. La Veta Avenue, Orange, CA, 92868, United States.""}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Bartlett', 'Affiliation': 'The University of Chicago, Department of Pediatrics, 5841 South Maryland Avenue, MC6054, Chicago, IL, 60637, United States.'}, {'ForeName': 'Archana', 'Initials': 'A', 'LastName': 'Chatterjee', 'Affiliation': 'University of South Dakota, Sanford School of Medicine, 1400 W 22nd St, Sioux Falls, SD, 57105, United States.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'DeBiasi', 'Affiliation': ""Children's National Health System, 111 Michigan Ave NW, Washington, DC, 20010, United States.""}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Dekker', 'Affiliation': 'Stanford School of Medicine, 300 Pasteur Drive, Room H313, Stanford, CA, 94305-5208, United States.'}, {'ForeName': 'Chandani', 'Initials': 'C', 'LastName': 'DeZure', 'Affiliation': ""Children's National Health System, 111 Michigan Ave NW, Washington, DC, 20010, United States.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Didion', 'Affiliation': ""Batson Children's Hospital, 2500 North State Street, Jackson, MS, 39216, United States.""}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Dominguez', 'Affiliation': ""Children's Hospital Colorado, 13123 East 16th Avenue, B100, Aurora, CO, 80045, United States.""}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'El Feghaly', 'Affiliation': ""Children's Mercy, 2401 Gillham Road, Kansas City, MO, 64108, United States.""}, {'ForeName': 'Guliz', 'Initials': 'G', 'LastName': 'Erdem', 'Affiliation': ""Nationwide Children's Hospital, 700 Children's Drive Suite T6B, Columbus, OH 43205, United States.""}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Halasa', 'Affiliation': 'Vanderbilt School of Medicine, 1161 21st Ave South, Nashville, TN, 37232, United States.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Harahsheh', 'Affiliation': ""Children's National Health System, 111 Michigan Ave NW, Washington, DC, 20010, United States.""}, {'ForeName': 'Mary Anne', 'Initials': 'MA', 'LastName': 'Jackson', 'Affiliation': ""Children's Mercy, 2401 Gillham Road, Kansas City, MO, 64108, United States.""}, {'ForeName': 'Preeti', 'Initials': 'P', 'LastName': 'Jaggi', 'Affiliation': 'Emory University School of Medicine, 1405 Clifton Rd. NE, Atlanta, GA 30322, United States.'}, {'ForeName': 'Supriya', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': ""Maria Fareri Children's Hospital at Westchester Medical Center and New York Medical College (NYMC), 100 Woods Road, Valhalla, NY, 10595, United States.""}, {'ForeName': 'Pei-Ni', 'Initials': 'PN', 'LastName': 'Jone', 'Affiliation': ""Children's Hospital Colorado, 13123 East 16th Avenue, B100, Aurora, CO, 80045, United States.""}, {'ForeName': 'Neeru', 'Initials': 'N', 'LastName': 'Kaushik', 'Affiliation': ""UCSF Benioff Children's Hospital-Oakland, 747 52nd street, Oakland, CA, 94609, United States.""}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Kurio', 'Affiliation': ""UCSF Benioff Children's Hospital-Oakland, 747 52nd street, Oakland, CA, 94609, United States.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lillian', 'Affiliation': 'Intuit, San Diego, CA, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lloyd', 'Affiliation': 'Emory University School of Medicine, 1405 Clifton Rd. NE, Atlanta, GA 30322, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Manaloor', 'Affiliation': 'Indiana University School of Medicine, 705 Riley Hospital Dr, RI 3032, Indianapolis, IN, 46202, United States.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'McNelis', 'Affiliation': ""UCSF Benioff Children's Hospital-San Francisco, 1691Mar West St, Tiburon, CA 94920, United States.""}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Michalik', 'Affiliation': ""Miller Children's Hospital, Long Beach, 2801 Atlantic Avenue, Long Beach, CA, 90806, United States.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Newburger', 'Affiliation': ""Children's Hospital Boston, 300 Longwood Ave., Boston, MA, 02115, United States.""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Newcomer', 'Affiliation': 'David Geffen School of Medicine at UCLA, 10833 Le Conte Avenue, A2-383 MDCC, Los Angeles, CA, 90095, United States.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Perkins', 'Affiliation': ""Children's National Health System, 111 Michigan Ave NW, Washington, DC, 20010, United States.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Portman', 'Affiliation': ""Seattle Children's, 4800 Sand Point Way NE, Seattle, WA, 98105, United States.""}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Romero', 'Affiliation': ""Arkansas Children's Hospital, 1 Children's Way, Little Rock, AR, 72202-3591, United States.""}, {'ForeName': 'Tova', 'Initials': 'T', 'LastName': 'Ronis', 'Affiliation': ""Children's National Health System, 111 Michigan Ave NW, Washington, DC, 20010, United States.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Rowley', 'Affiliation': ""The Ann & Robert H. Lurie Children's Hospital of Chicago, 310 E Superior Street, Morton 4-685B, Chicago, IL, 60611, United States.""}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Schneider', 'Affiliation': ""Batson Children's Hospital, 2500 North State Street, Jackson, MS, 39216, United States.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Schuster', 'Affiliation': ""Children's Mercy, 2401 Gillham Road, Kansas City, MO, 64108, United States.""}, {'ForeName': 'S Kristen Sexson', 'Initials': 'SKS', 'LastName': 'Tejtel', 'Affiliation': ""Texas Children's Hospital, 6621 Fannin St., MC-19345-C, Houston, TX, 77030, United States of America.""}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Sharma', 'Affiliation': ""Children's Health, University of Texas Southwestern Medical Center, 1935 Medical District Drive, Dallas, TX 75235, United States.""}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Simonsen', 'Affiliation': 'University of Nebraska Medical Center, 982162 Nebraska Medical Center, Omaha, NE 68198-2162, United States.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Szmuszkovicz', 'Affiliation': ""Children's Hospital Los Angeles, Division of Cardiology, 4650 Sunset Blvd., Los Angeles, CA, 90027, United States.""}, {'ForeName': 'Dongngan', 'Initials': 'D', 'LastName': 'Truong', 'Affiliation': 'University of Utah Health Care, 81 N. Mario Capecchi Drive, Salt Lake City, UT, 84113, United States.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wood', 'Affiliation': 'Indiana University School of Medicine, 705 Riley Hospital Dr, RI 3032, Indianapolis, IN, 46202, United States.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Yeh', 'Affiliation': 'Harbor-UCLA Medical Center, 1124 W. Carson St., Torrance, CA, 90509, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.02.008']
1373,30822490,The effect of periodontal treatment on patients with rheumatoid arthritis: The ESPERA randomised controlled trial.,"OBJECTIVES


To assess the effect of periodontal treatment on clinical and biochemical parameters of rheumatoid arthritis (RA) and quality of life (QoL) in patients with moderately active RA who were diagnosed with periodontitis.
METHODS


In this open-label randomised controlled trial, RA subjects (n = 22) were allocated to ""immediate"" or ""delayed"" periodontal treatment (full-mouth non-surgical scaling and root planing, systemic antibiotics, and oral hygiene instructions). The main outcome was the 3-month change on the Disease Activity Score 28 based on the Erythrocyte Sedimentation Rate (DAS28-ESR). The Health Assessment Questionnaire and the General Oral Health Assessment Index were used to assess general and oral health QoL, respectively.
RESULTS


Periodontal health significantly improved after periodontal treatment (P = 0.03). Periodontal treatment appeared to be safe but led to no significant effects on the DAS28-ESR (adjusted mean difference with 95% confidence interval (aMD) of -0.03 [-0.98; 0.92]). There was no evidence of improvement in the general QoL after periodontal treatment and no significant effect was found for the oral health QoL, despite a positive trend in the ""psychological impacts"" domain (aMD of 0.13 [-0.07; 0.33], P = 0.20).
CONCLUSIONS


Although no clinical effect of periodontal treatment on RA was identified, this trial provides important data to support periodontal care in RA patients. Periodontal treatment is safe and reduces oral inflammation with a possible effect on oral health QoL. Since both periodontitis and RA are complex and multifactorial chronic diseases, it is likely that patient-centred approaches involving both oral health professionals and rheumatologists will contribute to optimal patient care. ISRCTN79186420.",2019,"There was no evidence of improvement in the general QoL after periodontal treatment and no significant effect was found for the oral health QoL, despite a positive trend in the ""psychological impacts"" domain (aMD of 0.13","['RA patients', 'patients with moderately active RA who were diagnosed with periodontitis', 'patients with rheumatoid arthritis', 'RA subjects (n\u2009=\u200922']","['periodontal treatment', 'immediate"" or ""delayed"" periodontal treatment (full-mouth non-surgical scaling and root planing, systemic antibiotics, and oral hygiene instructions']","['rheumatoid arthritis (RA) and quality of life (QoL', 'DAS28-ESR', 'Periodontal health', 'oral health QoL', 'Disease Activity Score 28 based on the Erythrocyte Sedimentation Rate (DAS28-ESR', 'Health Assessment Questionnaire and the General Oral Health Assessment Index', 'general QoL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0085287', 'cui_str': 'Root Planings'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0204131', 'cui_str': 'Oral hygiene education'}]","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0034380'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0029162'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire (assessment scale)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0894497,"There was no evidence of improvement in the general QoL after periodontal treatment and no significant effect was found for the oral health QoL, despite a positive trend in the ""psychological impacts"" domain (aMD of 0.13","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Monsarrat', 'Affiliation': 'Paul Sabatier University, Dental Faculty, Toulouse University Hospital (CHU de Toulouse), 31062 Toulouse, France; Department of oral rehabilitation, Dental Faculty, 31062 Toulouse, France; STROMALab, Université de Toulouse, CNRS ERL 5311, EFS, ENVT, Inserm U1031, UPS, 31100 Toulouse, France. Electronic address: paul.monsarrat@univ-tlse3.fr.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Fernandez de Grado', 'Affiliation': 'Paul Sabatier University, Dental Faculty, Toulouse University Hospital (CHU de Toulouse), 31062 Toulouse, France; Inserm UMR1027, Paul-Sabatier University, 31000 Toulouse, France; Department of epidemiology and public health, Dental Faculty, 31062 Toulouse, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Constantin', 'Affiliation': 'Department of rheumatology, Hôpitaux de Toulouse, France and Université Paul Sabatier Toulouse III, 31300 Toulouse, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Willmann', 'Affiliation': 'Paul Sabatier University, Dental Faculty, Toulouse University Hospital (CHU de Toulouse), 31062 Toulouse, France.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Nabet', 'Affiliation': 'Paul Sabatier University, Dental Faculty, Toulouse University Hospital (CHU de Toulouse), 31062 Toulouse, France; Inserm UMR1027, Paul-Sabatier University, 31000 Toulouse, France; Department of epidemiology and public health, Dental Faculty, 31062 Toulouse, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Sixou', 'Affiliation': 'Paul Sabatier University, Dental Faculty, Toulouse University Hospital (CHU de Toulouse), 31062 Toulouse, France; Department of epidemiology and public health, Dental Faculty, 31062 Toulouse, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Cantagrel', 'Affiliation': 'Department of rheumatology, Hôpitaux de Toulouse, France and Université Paul Sabatier Toulouse III, 31300 Toulouse, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Barnetche', 'Affiliation': 'Rheumatology department, FHU ACRONIM, Bordeaux university hospital, 33076 Bordeaux, France.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Mehsen-Cetre', 'Affiliation': 'Rheumatology department, FHU ACRONIM, Bordeaux university hospital, 33076 Bordeaux, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Schaeverbeke', 'Affiliation': 'Rheumatology department, FHU ACRONIM, Bordeaux university hospital, 33076 Bordeaux, France.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Arrivé', 'Affiliation': 'Department of dentistry and oral health, Bordeaux university hospital, 33000 Bordeaux, France; Department of odontology, Bordeaux university, 33000 Bordeaux, France.'}, {'ForeName': 'Jean-Noel', 'Initials': 'JN', 'LastName': 'Vergnes', 'Affiliation': 'Paul Sabatier University, Dental Faculty, Toulouse University Hospital (CHU de Toulouse), 31062 Toulouse, France; Department of epidemiology and public health, Dental Faculty, 31062 Toulouse, France; Division of oral health and society, faculty of dentistry, McGill university, Montreal, Quebec H3A 0C7, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Joint bone spine,['10.1016/j.jbspin.2019.02.006']
1374,31419544,Crisaborole and atopic dermatitis skin biomarkers: An intrapatient randomized trial.,"BACKGROUND


Crisaborole ointment 2% is a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild-to-moderate atopic dermatitis (AD). The mechanism of action of crisaborole and its effects on lesional measures of disease severity are not yet well defined.
OBJECTIVE


This phase 2a, single-center, vehicle-controlled, intrapatient study was designed to further characterize the mechanism of action of crisaborole through evaluation of clinical efficacy and changes in skin biomarkers in adults (n = 40) with mild-to-moderate AD.
METHODS


Two target lesions were randomized in an intrapatient (1:1) manner to double-blind crisaborole/vehicle applied twice daily for 14 days. Patients then applied crisaborole (open-label) to all affected areas for 28 days. Punch biopsy specimens were collected for biomarker analysis at baseline, day 8 (optional), and day 15.
RESULTS


Crisaborole treatment resulted in early improvement in lesional signs/symptoms versus vehicle, with improvement in pruritus (pruritus numeric rating scale) observed as early as 24 hours after the first application. Crisaborole-treated lesions showed significant percentage improvement from baseline in lesional transcriptomic profile compared with vehicle at day 8 (91.15% vs 36.02%, P < 10 -15 ) that was sustained until day 15 (92.90% vs 49.59%, P < 10 -15 ). Crisaborole significantly modulated key AD biomarkers versus vehicle, including T H 2 and T H 17/T H 22 pathways and epidermal hyperplasia/proliferation. Molecular profiles and epidermal pathology normalized toward nonlesional skin and correlated with clinical changes in lesion severity and barrier function.
CONCLUSION


Crisaborole reversed biomarker profiles of skin inflammation and barrier function, with associated improvements in clinical efficacy measures, highlighting the therapeutic utility of targeting phosphodiesterase 4 in patients with AD.",2019,"Crisaborole-treated lesions showed significant percentage improvement from baseline in lesional transcriptome profile compared with vehicle at day 8 (91.15% vs 36.02%, P<10 -15 ) that was sustained until day 15 (92.90% vs 49.59%, P<10 -15 ).","['Crisaborole and atopic dermatitis skin biomarkers', 'adults (N = 40) with mild-to-moderate AD', 'mild-to-moderate atopic dermatitis (AD', 'Two target lesions']",[],"['skin inflammation and barrier function', 'pruritus (pruritus numeric rating scale', 'type 2 helper T-cell (Th2) and Th17/Th22 pathways and epidermal hyperplasia/proliferation', 'lesion signs/symptoms', 'lesional transcriptome profile']","[{'cui': 'C4301781', 'cui_str': 'crisaborole'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}]",[],"[{'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0222045'}, {'cui': 'C0242633', 'cui_str': 'T Helper2 Cells'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}, {'cui': 'C0334094', 'cui_str': 'Proliferation (morphologic abnormality)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1956267', 'cui_str': 'Transcriptome Profiles'}]",,0.0724075,"Crisaborole-treated lesions showed significant percentage improvement from baseline in lesional transcriptome profile compared with vehicle at day 8 (91.15% vs 36.02%, P<10 -15 ) that was sustained until day 15 (92.90% vs 49.59%, P<10 -15 ).","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bissonnette', 'Affiliation': 'Innovaderm Research, Montreal, Quebec, Canada.'}, {'ForeName': 'Ana B', 'Initials': 'AB', 'LastName': 'Pavel', 'Affiliation': 'Department of Dermatology and Laboratory for Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Aisleen', 'Initials': 'A', 'LastName': 'Diaz', 'Affiliation': 'Department of Dermatology and Laboratory for Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY; Ponce Health Sciences University School of Medicine, Ponce, Puerto Rico.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Werth', 'Affiliation': 'Pfizer, Collegeville, Pa.'}, {'ForeName': 'Chuanbo', 'Initials': 'C', 'LastName': 'Zang', 'Affiliation': 'Pfizer, Collegeville, Pa.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Vranic', 'Affiliation': 'Pfizer, Surrey, United Kingdom.'}, {'ForeName': 'Vivek S', 'Initials': 'VS', 'LastName': 'Purohit', 'Affiliation': 'Pfizer, Groton, Conn.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Zielinski', 'Affiliation': 'Pfizer, Collegeville, Pa.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Vlahos', 'Affiliation': 'Pfizer, Collegeville, Pa.'}, {'ForeName': 'Yeriel D', 'Initials': 'YD', 'LastName': 'Estrada', 'Affiliation': 'Department of Dermatology and Laboratory for Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Saint-Cyr Proulx', 'Affiliation': 'Innovaderm Research, Montreal, Quebec, Canada.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Ports', 'Affiliation': 'Pfizer, Groton, Conn.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Guttman-Yassky', 'Affiliation': 'Department of Dermatology and Laboratory for Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: Emma.Guttman@mountsinai.org.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.06.047']
1375,30871448,The influence of socio-demographic similarity and difference on adequate attendance of group psychoeducational cognitive behavioural therapy.,"Aim:  The study aimed to investigate the impact of socio-demographic similarity on the probability of attending an adequate dose of a psychoeducational group intervention (≥4 of 6 sessions).  Method:  The sample comprised 2071 patients (63% female, 93% White, 15% unemployed, mean age 43) who received the Stress Control intervention in the UK's national Improving Access to Psychological Therapies (IAPT) programme. Similarity indices were constructed to measure each patient's similarity to the rest of their group on four characteristics: age, gender, ethnicity, and neighbourhood deprivation (Index of Multiple Deprivation; IMD).  Results:  Multilevel analysis found that patients with greater IMD similarity to their group had significantly higher probabilities of attending an adequate dose of intervention ( p  = .026, controlling for absolute IMD). A cumulative effect of age similarity, ethnic similarity, and group size was also found, such that patients who were similar in age and ethnicity to their group had higher probabilities of adequate attendance in larger groups ( p  = .006).  Conclusions:  These results suggest that socio-demographic comparison (a.k.a. relational demography) may consciously or unconsciously impact on patients' attendance at group psychoeducational interventions, particularly regarding indicators of socio-economic similarity. Clinical implications include structuring group composition and/or intervention content to maximise attendance and therefore clinical effectiveness.",2020,"RESULTS


Multilevel analysis found that patients with greater IMD similarity to their group had significantly higher probabilities of attending an adequate dose of intervention (p = .026, controlling for absolute IMD).","['2071 patients (63% female, 93% White, 15% unemployed, mean age 43) who received the']","['psychoeducational group intervention (≥4 of 6 sessions', 'psychoeducational cognitive behavioural therapy', ""Stress Control intervention in the UK's national Improving Access to Psychological Therapies (IAPT) programme""]",['probabilities of adequate attendance'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0041674', 'cui_str': 'Unemployment'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0841584', 'cui_str': 'Psychological therapies (procedure)'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}]",2071.0,0.0396849,"RESULTS


Multilevel analysis found that patients with greater IMD similarity to their group had significantly higher probabilities of attending an adequate dose of intervention (p = .026, controlling for absolute IMD).","[{'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Firth', 'Affiliation': 'Clinical Psychology Unit, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Delgadillo', 'Affiliation': 'Clinical Psychology Unit, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Kellett', 'Affiliation': 'Clinical Psychology Unit, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Lucock', 'Affiliation': 'Centre for Applied Research in Health, University of Huddersfield, Huddersfield, UK.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2019.1589652']
1376,30871958,Effect of weight-bearing wrist movement with carpal-stabilizing taping on pain and range of motion in subjects with dorsal wrist pain: A randomized controlled trial.,"STUDY DESIGN


Randomized control trial.
INTRODUCTION


During weight-bearing wrist movement, potential stabilizing forces caused by carpal stabilizing taping (CST) may restrict movement of the carpal bones, allowing greater wrist joint extension.
PURPOSE OF THE STUDY


The purpose of study was to investigate the effect of CST during weight-bearing wrist movement on pain intensity and range of motion (ROM) of wrist extension in subjects with dorsal wrist pain.
METHODS


Thirty participants with dorsal wrist pain when weight bearing through the hand were randomly allocated into 2 groups: (1) a CST group using rigid tape and (2) placebo taping (PT) group using elastic tape. Subjects performed weight-bearing wrist movements with CST or PT in 6 sessions for 1 week. Active and passive ROM (AROM and PROM), and the visual analog scale (VAS) were assessed at baseline and after the intervention.
RESULTS


The AROM and PROM of wrist extension increased significantly in both groups compared with preintervention values (P < .01). Comparing the PT and CST groups, the differences between preintervention and postintervention AROM (mean difference [MD] = +8.6°) and PROM (MD = +6.8°) were significantly greater in the CST group than in the PT group (P < .01). The CST group also showed greater improvement in VAS compared with the PT group (MD = -18 mm) (P < .01).
CONCLUSION


We recommend CST during weight-bearing wrist movement as an effective intervention for both increasing wrist extension ROM and decreasing pain in patients with dorsal wrist pain during weight bearing through the hand.",2020,The AROM and PROM of wrist extension increased significantly in both groups compared with preintervention values (P < .01).,"['subjects with dorsal wrist pain', 'patients with dorsal wrist pain during weight bearing through the hand', 'Thirty participants with dorsal wrist pain when weight bearing through the hand']","['CST', 'carpal stabilizing taping (CST', 'CST or PT', 'CST group using rigid tape and (2) placebo taping (PT) group using elastic tape', 'weight-bearing wrist movement with carpal-stabilizing taping']","['pain intensity and range of motion (ROM) of wrist extension', 'preintervention and postintervention AROM', 'AROM and PROM of wrist extension', 'PROM', 'Active and passive ROM (AROM and PROM), and the visual analog scale (VAS', 'VAS', 'pain and range of motion']","[{'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0221785', 'cui_str': 'Wrist joint pain (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085086', 'cui_str': 'Finding of weight-bearing'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0560172', 'cui_str': 'cSt'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0231517', 'cui_str': 'Rigid (qualifier value)'}, {'cui': 'C1704747', 'cui_str': 'Tape (basic dose form)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0085086', 'cui_str': 'Finding of weight-bearing'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0015944', 'cui_str': 'Premature Rupture of Membrane (Pregnancy)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",30.0,0.0586489,The AROM and PROM of wrist extension increased significantly in both groups compared with preintervention values (P < .01).,"[{'ForeName': 'Geun-Su', 'Initials': 'GS', 'LastName': 'Kim', 'Affiliation': 'Department of KEMA Therapy, Graduate School of Humanities Industry, Joongbu University, Geumsan, Republic of Korea.'}, {'ForeName': 'Jong-Hyuck', 'Initials': 'JH', 'LastName': 'Weon', 'Affiliation': 'Department of Physical Therapy, College of Health & Welfare, Kinesiopathologic Science Institute, Joongbu University, Geumsan, Republic of Korea.'}, {'ForeName': 'Moon-Hwan', 'Initials': 'MH', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, Wonju Christian Hospital, Wonju College of Medicine, Yonsei University, Wonju, Republic of Korea.'}, {'ForeName': 'Eun-Kyung', 'Initials': 'EK', 'LastName': 'Koh', 'Affiliation': 'Department of Physical Therapy, Masan University, Changwon, Republic of Korea.'}, {'ForeName': 'Do-Young', 'Initials': 'DY', 'LastName': 'Jung', 'Affiliation': 'Department of Physical Therapy, College of Health & Welfare, Kinesiopathologic Science Institute, Joongbu University, Geumsan, Republic of Korea. Electronic address: ptsports@joongbu.ac.kr.'}]",Journal of hand therapy : official journal of the American Society of Hand Therapists,['10.1016/j.jht.2019.02.001']
1377,30738780,"Addition of radium-223 to abiraterone acetate and prednisone or prednisolone in patients with castration-resistant prostate cancer and bone metastases (ERA 223): a randomised, double-blind, placebo-controlled, phase 3 trial.","BACKGROUND


Abiraterone acetate plus prednisone or prednisolone improves progression-free survival and overall survival in patients with metastatic castration-resistant prostate cancer. Radium-223 improves overall survival and delays the onset of symptomatic skeletal events in patients with castration-resistant prostate cancer and bone metastases. We assessed concurrent treatment with abiraterone acetate plus prednisone or prednisolone and radium-223 in such patients.
METHODS


We did a randomised, double-blind, placebo-controlled, phase 3 trial at 165 oncology and urology centres in 19 countries. Eligible patients were aged 18 years or older, and had histologically confirmed, progressive, chemotherapy-naive, asymptomatic or mildly symptomatic castration-resistant prostate cancer and bone metastases, Eastern Cooperative Oncology Group performance status of 0 or 1, life expectancy of at least 6 months, and adequate haematological, renal, and liver function. Participants were randomly assigned (1:1) according to a permuted block design (block size 4) via interactive response technology to receive up to six intravenous injections of radium-223 (55 kBq/kg) or matching placebo once every 4 weeks. All patients were also scheduled to receive oral abiraterone acetate 1000 mg once daily plus oral prednisone or prednisolone 5 mg twice daily during and after radium-223 or placebo treatment. The primary endpoint was symptomatic skeletal event-free survival, which was assessed in the intention-to-treat population. Safety analyses were done in all patients who received at least one dose of any study drug. This trial is registered with ClinicalTrials.gov, number NCT02043678. Enrolment has been completed, and follow-up is ongoing.
FINDINGS


Between March 30, 2014, and Aug 12, 2016, 806 patients were randomly assigned to receive radium-223 (n=401) or placebo (n=405) in addition to abiraterone acetate plus prednisone or prednisolone. The study was unblinded prematurely, on Nov 17, 2017, after more fractures and deaths were noted in the radium-223 group than in the placebo group (in an unplanned ad-hoc analysis), but all patients had completed radium-223 or placebo before this date. At the primary analysis (data cutoff Feb 15, 2018), 196 (49%) of 401 patients in radium-223 group had had at least one symptomatic skeletal event or died, compared with 190 (47%) of 405 patients in the placebo group (median follow-up 21·2 months [IQR 17·0-25·8]). Median symptomatic skeletal event-free survival was 22·3 months (95% CI 20·4-24·8) in the radium-223 group and 26·0 months (21·8-28·3) in the placebo group (hazard ratio 1·122 [95% CI 0·917-1·374]; p=0·2636). Fractures (any grade) occurred in 112 (29%) of 392 patients in the radium-223 group and 45 (11%) of 394 patients in the placebo group. The most common grade 3-4 treatment-emergent adverse events were hypertension (43 [11%] patients in the radium-223 group vs 52 [13%] patients in the placebo group), fractures (36 [9%] vs 12 [3%]) and increased alanine aminotransferase concentrations (34 [9%] vs 28 [7%]). Serious treatment-emergent adverse events occurred in 160 (41%) patients in the radium-223 group and 155 (39%) in the placebo group. Treatment-related deaths occurred in two (1%) patients in the radium-223 group (acute myocardial infarction and interstitial lung disease) and one (<1%) in the placebo group (arrhythmia).
INTERPRETATION


The addition of radium-223 to abiraterone acetate plus prednisone or prednisolone did not improve symptomatic skeletal event-free survival in patients with castration-resistant prostate cancer and bone metastases, and was associated with an increased frequency of bone fractures compared with placebo. Thus, we do not recommend use of this combination.
FUNDING


Bayer.",2019,Median symptomatic skeletal event-free survival was 22·3 months (95% CI 20·4-24·8) in the radium-223 group and 26·0 months (21·8-28·3) in the placebo group (hazard ratio,"['Eligible patients were aged 18 years or older, and had histologically confirmed, progressive, chemotherapy-naive, asymptomatic or mildly symptomatic castration-resistant prostate cancer and bone metastases', 'Between March 30, 2014, and Aug 12, 2016, 806 patients', 'patients with castration-resistant prostate cancer and bone metastases (ERA 223', '165 oncology and urology centres in 19 countries', 'patients with castration-resistant prostate cancer and bone metastases', 'patients with metastatic castration-resistant prostate cancer']","['permuted block design (block size 4) via interactive response technology to receive up to six intravenous injections of radium-223 (55 kBq/kg) or matching placebo', 'abiraterone acetate plus prednisone or prednisolone and radium-223', 'radium-223 or placebo', 'placebo', 'oral abiraterone acetate 1000 mg once daily plus oral prednisone or prednisolone', 'Abiraterone acetate plus prednisone or prednisolone', 'Radium-223', 'abiraterone acetate plus prednisone or prednisolone', 'radium-223', 'radium-223 to abiraterone acetate and prednisone or prednisolone']","['symptomatic skeletal event-free survival', 'frequency of bone fractures', 'symptomatic skeletal event or died', 'adequate haematological, renal, and liver function', 'progression-free survival and overall survival', 'fractures and deaths', 'Serious treatment-emergent adverse events', 'alanine aminotransferase concentrations', 'deaths', 'overall survival', 'Median symptomatic skeletal event-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1328504', 'cui_str': 'Castration-resistant prostate cancer'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0021494', 'cui_str': 'Intravenous Injections'}, {'cui': 'C0303282', 'cui_str': 'Ra-223 radioisotope'}, {'cui': 'C0560040', 'cui_str': 'kBq'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2607886', 'cui_str': 'abiraterone acetate'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",806.0,0.756152,Median symptomatic skeletal event-free survival was 22·3 months (95% CI 20·4-24·8) in the radium-223 group and 26·0 months (21·8-28·3) in the placebo group (hazard ratio,"[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Smith', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, MA, USA. Electronic address: smith.matthew@mgh.harvard.edu.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Parker', 'Affiliation': 'Royal Marsden NHS Foundation Trust and Institute of Cancer Research, Sutton, UK.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': 'University of Montreal Hospital Center, Montreal, QC, Canada.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Miller', 'Affiliation': 'Charité Berlin, Berlin, Germany.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Tombal', 'Affiliation': 'Cliniques Universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'Quan Sing', 'Initials': 'QS', 'LastName': 'Ng', 'Affiliation': 'National Cancer Centre Singapore, Singapore.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Boegemann', 'Affiliation': 'University of Muenster Medical Center, Muenster, Germany.'}, {'ForeName': 'Vsevolod', 'Initials': 'V', 'LastName': 'Matveev', 'Affiliation': 'N N Blokhin Cancer Research Center, Moscow, Russia.'}, {'ForeName': 'Josep Maria', 'Initials': 'JM', 'LastName': 'Piulats', 'Affiliation': 'Catalan Cancer Institute, IDIBELL, CIBERONC, Barcelona, Spain.'}, {'ForeName': 'Luis Eduardo', 'Initials': 'LE', 'LastName': 'Zucca', 'Affiliation': 'Barretos Cancer Hospital, Barretos, Brazil.'}, {'ForeName': 'Oleg', 'Initials': 'O', 'LastName': 'Karyakin', 'Affiliation': 'Medical Radiological Research Center, Kaluga, Russia.'}, {'ForeName': 'Go', 'Initials': 'G', 'LastName': 'Kimura', 'Affiliation': 'Nippon Medical School Hospital, Tokyo, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Matsubara', 'Affiliation': 'National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'William Carlos', 'Initials': 'WC', 'LastName': 'Nahas', 'Affiliation': 'Instituto Do Cancer Do Estado De Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Nolè', 'Affiliation': 'IEO, Istituto Europeo di Oncologia, IRCCS, Milan, Italy.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Rosenbaum', 'Affiliation': 'Rabin Medical Center Davidoff Center, Petach-Tikva, Israel.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Heidenreich', 'Affiliation': 'University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Kakehi', 'Affiliation': 'Kagawa University, Kagawa, Japan.'}, {'ForeName': 'Amily', 'Initials': 'A', 'LastName': 'Zhang', 'Affiliation': 'Bayer HealthCare Pharmaceuticals, Whippany, NJ, USA.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Krissel', 'Affiliation': 'Bayer, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Teufel', 'Affiliation': 'Bayer HealthCare Pharmaceuticals, Whippany, NJ, USA.'}, {'ForeName': 'Junwu', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': 'Bayer HealthCare Pharmaceuticals, Whippany, NJ, USA.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Wagner', 'Affiliation': 'Bayer Consumer Care, Basel, Switzerland.'}, {'ForeName': 'Celestia', 'Initials': 'C', 'LastName': 'Higano', 'Affiliation': 'University of Washington and Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(18)30860-X']
1378,31705384,Creating Supportive Contexts for Early Adolescents during the First Year of Middle School: Impact of a Developmentally Responsive Multi-Component Intervention.,"The transition to middle school is recognized as a period of increased risk for students' adjustment difficulties across the academic, behavioral, and social domains, underscoring the need for developmentally responsive interventions that address these potential vulnerabilities. This study examined the impact of a multi-component intervention on students' perceived adjustment during the first year of middle school using a cluster randomized controlled trial design. A total of 24 metropolitan schools (12 intervention), 220 teachers (122 intervention), and 2925 students (1537 intervention) participated. Teachers in intervention schools received training and consultation in the Behavioral, Academic, and Social Engagement (BASE) classroom management model. Significant intervention effects, moderated by students' gender, race/ethnicity, and economic status, were found for self-reported social anxiety, defiance, willingness to protect peers being bullied, and emotional problems. The results suggest that teachers trained in the BASE model were better able to create supportive classroom contexts during the middle school transition which promoted positive adjustment for particular students. This study stresses the importance of using developmentally appropriate strategies across correlated domains to reduce adjustment difficulties during the transition to middle school.",2020,The results suggest that teachers trained in the BASE model were better able to create supportive classroom contexts during the middle school transition which promoted positive adjustment for particular students.,"[""students' perceived adjustment during the first year of middle school"", 'Early Adolescents during the First Year of Middle School', 'A total of 24 metropolitan schools (12 intervention), 220 teachers (122 intervention), and 2925 students (1537 intervention) participated']","['Developmentally Responsive Multi-Component Intervention', 'training and consultation in the Behavioral, Academic, and Social Engagement (BASE) classroom management model', 'multi-component intervention']","['social anxiety, defiance, willingness to protect peers being bullied, and emotional problems']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}]","[{'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0424166', 'cui_str': 'Social Anxiety'}, {'cui': 'C0424348', 'cui_str': 'Defiant behavior (finding)'}, {'cui': 'C0424318', 'cui_str': 'Bullying'}, {'cui': 'C0677660', 'cui_str': 'Emotional problems (finding)'}]",220.0,0.0153269,The results suggest that teachers trained in the BASE model were better able to create supportive classroom contexts during the middle school transition which promoted positive adjustment for particular students.,"[{'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Dawes', 'Affiliation': 'College of Education, University of South Carolina, Columbia, SC, USA. mollydawes@sc.edu.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Farmer', 'Affiliation': 'School of Education, University of Pittsburg, Pittsburg, PA, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Hamm', 'Affiliation': 'School of Education, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': 'College of Education, The Pennsylvania State University, State College, PA, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Norwalk', 'Affiliation': 'Department of Psychology, North Carolina State University, Raleigh, NC, USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Sterrett', 'Affiliation': 'School of Education, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Kerrylin', 'Initials': 'K', 'LastName': 'Lambert', 'Affiliation': 'School of Education, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Journal of youth and adolescence,['10.1007/s10964-019-01156-2']
1379,30824339,Effects of gamma-hydroxybutyrate on neurophysiological correlates of performance and conflict monitoring.,"Performance and conflict monitoring (PM and CM) represent two essential cognitive abilities, required to respond appropriately to demanding tasks. PM and CM can be investigated using event-related brain potentials (ERP) and associated neural oscillations. Namely, the error-related negativity (ERN) represents a correlate of PM, whereas the N2 component reflects the process of CM. Both ERPs originate in the anterior cingulate cortex (ACC) and PM specifically has been shown to be susceptible to gamma-aminobutyric acid (GABA) A receptor activation. Contrarily, the specific effects of GABA B  receptor (GABA B R) stimulation on PM and CM are unknown. Thus, the effects of gamma-hydroxybutyrate (GHB; 20 and 35 mg/kg), a predominant GABA B R agonist, on behavioral and electrophysiological correlates of PM and CM were here assessed in 15 healthy male volunteers, using the Eriksen-Flanker paradigm in a randomized, double-blind, placebo-controlled, cross-over study. Electroencephalographic (EEG) data were analyzed in the time and time-frequency domains. GHB prolonged reaction times, without affecting error rates or post-error slowing. Moreover, GHB decreased ERN amplitudes and associated neural oscillations in the theta/alpha1 range. Similarly, neural oscillations associated with the N2 were reduced in the theta/alpha1 range, while N2 amplitude was conversely increased. Hence, GHB shows a dissociating effect on electrophysiological correlates of PM and CM. Reduced ERN likely derives from a GABA B R-mediated increase in dopaminergic signaling, disrupting the generation of prediction errors, whereas an enhanced N2 suggests an increased susceptibility towards external stimuli. Conclusively, GHB is the first drug reported, thus far, to have opposite effects on PM and CM, underlined by its unique electrophysiological signature.",2019,"Similarly, neural oscillations associated with the N2 were reduced in the theta/alpha1 range, while N2 amplitude was conversely increased.",['15 healthy male volunteers'],"['placebo', 'gamma-hydroxybutyrate', 'Performance and conflict monitoring (PM and CM', 'GABA B  receptor (GABA B R) stimulation', 'predominant GABA B R agonist', 'gamma-hydroxybutyrate (GHB']","['neurophysiological correlates of performance and conflict monitoring', 'Electroencephalographic (EEG) data', 'GHB decreased ERN amplitudes and associated neural oscillations', 'GHB prolonged reaction times', 'neural oscillations']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0000503', 'cui_str': '4-Hydroxybutyrate (substance)'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0052887', 'cui_str': 'GABA-B Receptor'}, {'cui': 'C0016904', 'cui_str': 'gamma-Aminobutyric Acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0000503', 'cui_str': '4-Hydroxybutyrate (substance)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",15.0,0.0585166,"Similarly, neural oscillations associated with the N2 were reduced in the theta/alpha1 range, while N2 amplitude was conversely increased.","[{'ForeName': 'Dario A', 'Initials': 'DA', 'LastName': 'Dornbierer', 'Affiliation': 'Experimental and Clinical Pharmacopsychology, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, Lenggstrasse 31, CH-8032 Zurich, Switzerland; Institute of Pharmacology and Toxicology, University of Zurich, Winterthurerstrasse 190, 8057 Zürich, Switzerland. Electronic address: dornbierer@pharma.uzh.ch.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kometer', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging Research Unit, Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital of Psychiatry Zurich, Lenggstrasse 31, 8032 Zurich, Switzerland.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Von Rotz', 'Affiliation': 'Experimental and Clinical Pharmacopsychology, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, Lenggstrasse 31, CH-8032 Zurich, Switzerland.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Studerus', 'Affiliation': 'Center for Gender Research and Early Detection, Kornhausgasse 7, 4051 Basel, Switzerland.'}, {'ForeName': 'Jürg', 'Initials': 'J', 'LastName': 'Gertsch', 'Affiliation': 'Institute of Biochemistry and Molecular Medicine, University of Bern, Bühlstrasse 28, 3012 Bern, Switzerland.'}, {'ForeName': 'M Salomé', 'Initials': 'MS', 'LastName': 'Gachet', 'Affiliation': 'Institute of Biochemistry and Molecular Medicine, University of Bern, Bühlstrasse 28, 3012 Bern, Switzerland.'}, {'ForeName': 'Franz X', 'Initials': 'FX', 'LastName': 'Vollenweider', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging Research Unit, Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital of Psychiatry Zurich, Lenggstrasse 31, 8032 Zurich, Switzerland; Neuroscience Center Zurich, University and ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Seifritz', 'Affiliation': 'Experimental and Clinical Pharmacopsychology, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, Lenggstrasse 31, CH-8032 Zurich, Switzerland; Neuroscience Center Zurich, University and ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Oliver G', 'Initials': 'OG', 'LastName': 'Bosch', 'Affiliation': 'Experimental and Clinical Pharmacopsychology, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, Lenggstrasse 31, CH-8032 Zurich, Switzerland.'}, {'ForeName': 'Boris B', 'Initials': 'BB', 'LastName': 'Quednow', 'Affiliation': 'Experimental and Clinical Pharmacopsychology, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, Lenggstrasse 31, CH-8032 Zurich, Switzerland; Neuroscience Center Zurich, University and ETH Zurich, Zurich, Switzerland.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2019.02.004']
1380,31493887,Long-term sublingual immunotherapy for peanut allergy in children: Clinical and immunologic evidence of desensitization.,"BACKGROUND


Peanut sublingual immunotherapy (SLIT) for 1 year has been shown to induce modest clinical desensitization in allergic children. Studies of oral immunotherapy, epicutaneous immunotherapy, and SLIT have suggested additional benefit with extended treatment.
OBJECTIVE


We sought to investigate the safety, clinical effectiveness, and immunologic changes with long-term SLIT in children with peanut allergy.
METHODS


Children with peanut allergy aged 1 to 11 years underwent extended maintenance SLIT with 2 mg/d peanut protein for up to 5 years. Subjects with peanut skin test wheals of less than 5 mm and peanut-specific IgE levels of less than 15 kU/L were allowed to discontinue therapy early. Desensitization was assessed through a double-blind, placebo-controlled food challenge (DBPCFC) with up to 5000 mg of peanut protein after completion of SLIT dosing. Sustained unresponsiveness was further assessed by using identical DBPCFCs after 2 to 4 weeks without peanut exposure.
RESULTS


Thirty-seven of 48 subjects completed 3 to 5 years of peanut SLIT, with 67% (32/48) successfully consuming 750 mg or more during DBPCFCs. Furthermore, 25% (12/48) passed the 5000-mg DBPCFC without clinical symptoms, with 10 of these 12 demonstrating sustained unresponsiveness after 2 to 4 weeks. Side effects were reported with 4.8% of doses, with transient oropharyngeal itching reported most commonly. Side effects requiring antihistamine treatment were uncommon (0.21%), and no epinephrine was administered. Peanut skin test wheals, peanut-specific IgE levels, and basophil activation decreased significantly, and peanut-specific IgG 4  levels increased significantly after peanut SLIT.
CONCLUSION


Extended-therapy peanut SLIT provided clinically meaningful desensitization in the majority of children with peanut allergy that was balanced with ease of administration and a favorable safety profile.",2019,"Peanut skin test wheals, peanut-specific IgE levels, and basophil activation decreased significantly, and peanut-specific IgG 4  levels increased significantly after peanut SLIT.
","['Children with peanut allergy aged 1 to 11\xa0years underwent', 'children', 'allergic children', 'children with peanut allergy', 'Thirty-seven of 48 subjects completed 3 to 5\xa0years of peanut SLIT, with 67% (32/48) successfully consuming 750\xa0mg or more during DBPCFCs']","['oral immunotherapy, epicutaneous immunotherapy, and SLIT', 'placebo-controlled food challenge (DBPCFC', 'sublingual immunotherapy', 'epinephrine', 'Peanut sublingual immunotherapy (SLIT', 'extended maintenance SLIT with 2\xa0mg/d peanut protein', 'antihistamine']","['Peanut skin test wheals, peanut-specific IgE levels, and basophil activation', 'Side effects', 'peanut-specific IgG 4  levels']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0559470', 'cui_str': 'Groundnut Hypersensitivity'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0184904', 'cui_str': 'Slitting (procedure)'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C0184904', 'cui_str': 'Slitting (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C3658366', 'cui_str': 'Sublingual Immunotherapy'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0019590', 'cui_str': 'Antihistamines'}]","[{'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0037296', 'cui_str': 'Skin Tests'}, {'cui': 'C0221232', 'cui_str': 'Wheal'}, {'cui': 'C1270751', 'cui_str': 'Arachis hypogaea specific immunoglobulin E (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4316898', 'cui_str': 'Basophil, segmented (cell)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}]",48.0,0.108432,"Peanut skin test wheals, peanut-specific IgE levels, and basophil activation decreased significantly, and peanut-specific IgG 4  levels increased significantly after peanut SLIT.
","[{'ForeName': 'Edwin H', 'Initials': 'EH', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, Division of Rheumatology, Allergy and Immunology, University of North Carolina School of Medicine, Chapel Hill, NC. Electronic address: edwinkim@email.unc.edu.'}, {'ForeName': 'Luanna', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Pediatrics, Division of Allergy, Immunology and Rheumatology, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Ye', 'Affiliation': 'Department of Pediatrics, Division of Allergy, Immunology and Rheumatology, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Rishu', 'Initials': 'R', 'LastName': 'Guo', 'Affiliation': 'Department of Pediatrics, Division of Allergy, Immunology and Rheumatology, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Quefeng', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, University of North Carolina Gillings School of Global Public Health, Chapel Hill, NC.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Kulis', 'Affiliation': 'Department of Pediatrics, Division of Allergy, Immunology and Rheumatology, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'A Wesley', 'Initials': 'AW', 'LastName': 'Burks', 'Affiliation': 'Department of Pediatrics, Division of Allergy, Immunology and Rheumatology, University of North Carolina School of Medicine, Chapel Hill, NC.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.07.030']
1381,30821614,"Fathers' and mothers' attachment styles, couple conflict, parenting quality, and children's behavior problems: an intervention test of mediation.","A diverse sample of 239 primarily low-income couples participated in a random controlled trial of the Supporting Father Involvement couples group intervention. In this report, we examined the value of adding measures of fathers' attachment style and parenting to mothers' measures in order to explain variations in children's behavior problems. We also tested the hypothesis that the link between intervention-induced reductions in couple conflict and reductions in anxious/harsh parenting can be explained by intervention effects on parents' attachment insecurity or on anxiety and depression. Fathers' attachment security and parenting behavior added significantly to mothers' in accounting for children's internalizing and externalizing problem behaviors. Fathers' anxious attachment style  and  anxiety/depression mediated the link between post-intervention reductions in parental conflict and anxious/harsh parenting. For mothers, only improvements in attachment security accounted for those links. The findings support the need for attachment researchers to consider the contributions of both parents to their children's development.",2019,Fathers' attachment security and parenting behavior added significantly to mothers' in accounting for children's internalizing and externalizing problem behaviors.,"[""children's behavior problems"", '239 primarily low-income couples participated in a random controlled trial of the Supporting Father Involvement couples group intervention']",[],"[""Fathers' and mothers' attachment styles, couple conflict, parenting quality, and children's behavior problems"", 'attachment security', ""Fathers' anxious attachment style and anxiety/depression"", ""Fathers' attachment security and parenting behavior""]","[{'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0015671', 'cui_str': 'Fathers'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],"[{'cui': 'C0015671', 'cui_str': 'Fathers'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]",239.0,0.0294287,Fathers' attachment security and parenting behavior added significantly to mothers' in accounting for children's internalizing and externalizing problem behaviors.,"[{'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Cowan', 'Affiliation': 'a Department of Psychology and Institute of Human Development, University of California , Berkeley , USA.'}, {'ForeName': 'Carolyn Pape', 'Initials': 'CP', 'LastName': 'Cowan', 'Affiliation': 'a Department of Psychology and Institute of Human Development, University of California , Berkeley , USA.'}, {'ForeName': 'Marsha Kline', 'Initials': 'MK', 'LastName': 'Pruett', 'Affiliation': 'b Smith College School for Social Work , Northampton , MA , USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Pruett', 'Affiliation': 'c Yale University School of Medicine , New Haven , CT , USA.'}]",Attachment & human development,['10.1080/14616734.2019.1582600']
1382,30070753,Post hoc analysis of the Exenatide-PD trial-Factors that predict response.,"Exenatide, a glucagon-like peptide-1 agonist and a licensed treatment for Type 2 diabetes significantly reduced deterioration in motor symptoms in patients with Parkinson's disease in a randomized, placebo-controlled trial. In addition, there were trends favouring the exenatide group in assessments of nonmotor symptoms, cognition, and quality of life. The aim of this exploratory post hoc analysis was to generate new hypotheses regarding (a) whether candidate baseline factors might predict the magnitude of response to exenatide; and (b) whether the beneficial effects of exenatide reported for the overall population are consistent in various subgroups of patients. Univariate and multivariate analyses were conducted to determine possible predictors of motor response to exenatide in this cohort. Potential treatment by subgroup interactions for changes in; motor severity, nonmotor symptoms, cognition, and quality of life after 48-weeks treatment with exenatide were evaluated among post hoc subgroups defined by age, motor phenotype, disease duration, disease severity, body mass index (BMI), and insulin resistance. In the subgroup analyses, exenatide once-weekly was associated with broadly improved outcome measures assessing motor severity, nonmotor symptoms, cognition, and quality of life across all subgroups, however, tremor-dominant phenotype and lower Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part-2 scores predicted greatest motor response to exenatide and there was an indication that patients with older age of onset and disease duration over 10 years responded less well. While patients with a range of demographic and clinical factors can potentially benefit from exenatide once-weekly, these data support an emphasis towards recruiting patients at earlier disease in future planned clinical trials of gluacagon-like peptide-1 (GLP-1) receptor agonists in Parkinson's disease (PD).",2019,"In the subgroup analyses, exenatide once-weekly was associated with broadly improved outcome measures assessing motor severity, nonmotor symptoms, cognition, and quality of life across all subgroups, however, tremor-dominant phenotype and lower Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)","[""patients with Parkinson's disease"", ""Parkinson's disease (PD""]","['Exenatide, a glucagon-like peptide-1 agonist', 'placebo', 'exenatide']","[""motor severity, nonmotor symptoms, cognition, and quality of life across all subgroups, however, tremor-dominant phenotype and lower Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS"", 'nonmotor symptoms, cognition, and quality of life', 'motor severity, nonmotor symptoms, cognition, and quality of life', 'motor phenotype, disease duration, disease severity, body mass index (BMI), and insulin resistance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0034380'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0026650', 'cui_str': 'Movement Disorder Syndromes'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0222045'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}]",,0.0731179,"In the subgroup analyses, exenatide once-weekly was associated with broadly improved outcome measures assessing motor severity, nonmotor symptoms, cognition, and quality of life across all subgroups, however, tremor-dominant phenotype and lower Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)","[{'ForeName': 'Dilan', 'Initials': 'D', 'LastName': 'Athauda', 'Affiliation': 'Sobell Department of Motor Neuroscience, UCL Institute of Neurology & The National Hospital for Neurology and Neurosurgery, London, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Maclagan', 'Affiliation': 'UCL Comprehensive Clinical Trials Unit (UCL CCTU), London, UK.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Budnik', 'Affiliation': 'Leonard Wolfson Experimental Neuroscience Centre, London, UK.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Zampedri', 'Affiliation': 'Leonard Wolfson Experimental Neuroscience Centre, London, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Hibbert', 'Affiliation': 'UCL Comprehensive Clinical Trials Unit (UCL CCTU), London, UK.'}, {'ForeName': 'Iciar', 'Initials': 'I', 'LastName': 'Aviles-Olmos', 'Affiliation': 'Sobell Department of Motor Neuroscience, UCL Institute of Neurology & The National Hospital for Neurology and Neurosurgery, London, UK.'}, {'ForeName': 'Kashfia', 'Initials': 'K', 'LastName': 'Chowdhury', 'Affiliation': 'UCL Comprehensive Clinical Trials Unit (UCL CCTU), London, UK.'}, {'ForeName': 'Simon S', 'Initials': 'SS', 'LastName': 'Skene', 'Affiliation': 'UCL Comprehensive Clinical Trials Unit (UCL CCTU), London, UK.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Limousin', 'Affiliation': 'Sobell Department of Motor Neuroscience, UCL Institute of Neurology & The National Hospital for Neurology and Neurosurgery, London, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Foltynie', 'Affiliation': 'Sobell Department of Motor Neuroscience, UCL Institute of Neurology & The National Hospital for Neurology and Neurosurgery, London, UK.'}]",The European journal of neuroscience,['10.1111/ejn.14096']
1383,30770294,"Patient-reported outcomes following enzalutamide or placebo in men with non-metastatic, castration-resistant prostate cancer (PROSPER): a multicentre, randomised, double-blind, phase 3 trial.","BACKGROUND


In the PROSPER trial, enzalutamide significantly improved metastasis-free survival in patients with non-metastatic, castration-resistant prostate cancer. Here, we report the results of patient-reported outcomes of this study.
METHODS


In the randomised, double-blind, placebo-controlled, phase 3 PROSPER trial, done at 254 study sites worldwide, patients aged 18 years or older with non-metastatic, castration-resistant prostate cancer and a prostate-specific antigen doubling time of up to 10 months were randomly assigned (2:1) via an interactive voice web recognition system to receive oral enzalutamide (160 mg per day) or placebo. Randomisation was stratified by prostate-specific antigen doubling time and baseline use of a bone-targeting agent. The primary endpoint was metastasis-free survival, reported elsewhere. Secondary efficacy endpoints, reported here, were pain progression (assessed by the Brief Pain Inventory Short Form [BPI-SF] questionnaire) and health-related quality of life (assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-PR25], the EuroQoL 5-Dimensions 5-Levels health questionnaire visual analogue scale [EQ-5D-FL, EQ-VAS], and the Functional Assessment of Cancer Therapy-Prostate [FACT-P] questionnaires). Patients completed questionnaires at baseline, week 17, and every 16 weeks thereafter until treatment discontinuation. We used predefined questionnaire thresholds to identify clinically meaningful changes. Enrolment for PROSPER is complete and follow-up continues. This trial is registered with ClinicalTrials.gov, number NCT02003924.
FINDINGS


Between Nov 26, 2013, and June 28, 2017, 1401 patients were enrolled and randomly assigned to receive enzalutamide (n=933) or placebo (n=468). Median follow-up was 18·5 months (IQR 10·7-29·2) in the enzalutamide group and 15·1 months (7·4-25·9) in the placebo group. Patient-reported outcome scores at baseline were similar between groups. Changes in least squares mean from baseline to week 97 favoured enzalutamide versus placebo for FACT-P social and family wellbeing (0·30 [95% CI -0·25 to 0·85] vs -0·64 [-1·51 to 0·24]; difference 0·94 [95% CI 0·02 to 1·85]; p=0·045) and disfavoured enzalutamide versus placebo for EORTC QLQ-PR25 hormonal treatment-related symptoms (1·55 [0·26 to 2·83) vs -1·83 [-3·86 to 0·20]; difference 3·38 [1·24 to 5·51]; p=0·0020); neither of these changes were clinically meaningful. No significant differences were observed between treatments for changes from baseline to week 97 in any other patient-reported outcome score. Time to clinically meaningful pain progression as assessed by BPI-SF pain severity was longer with enzalutamide than with placebo (median 36·83 months, [95% CI 34·69 to not reached [NR] vs NR; hazard ratio [HR] 0·75 [95% CI 0·57 to 0·97]; p=0·028); there was no significant difference for BPI-SF item 3 or pain interference. Time to clinically meaningful symptom worsening was longer with enzalutamide than with placebo for EORTC QLQ-PR25 urinary symptoms (median 36·86 months [95% CI 33·35 to NR] vs 25·86 [18·53 to 29·47]; HR 0·58 [95% CI 0·46 to 0·72]; p<0·0001) and bowel symptoms (33·15 [29·50 to NR] vs 25·89 [18·43 to 29·67]; 0·72 [0·59 to 0·89]; p=0·0018), and clinically meaningful health-related quality of life as assessed by FACT-P total score (22·11 [18·63 to 25·86] vs 18·43 [14·85-19·35]; 0·83 [0·69 to 0·99]; p=0·037), emotional wellbeing (36·73 [33·12 to 38·21] vs 29·47 [22·18 to 33·15]; 0·69 [0·55 to 0·86]; p=0·0008), and prostate cancer subscale (18·43 [14·85 to 18·66] vs 14·69 [11·07 to 16·20]; 0·79 [0·67 to 0·93]; p=0·0042), although there was no significant difference for other FACT-P scores. Time to clinically meaningful deterioration in EORTC QLQ-PR25 hormonal treatment-related symptoms was shorter with enzalutamide than with placebo (median 33·15 months [95% CI 29·60 to NR] vs 36·83 [29·47 to NR]; HR 1·29 [95% CI 1·02 to 1·63]; p=0·035). Time to deterioration of EQ-VAS was significantly longer for enzalutamide than for placebo (median 22·11 months [95% CI 18·46 to 25·66] vs 14·75 [11·07 to 18·17]; HR 0·75 [95% CI 0·63 to 0·90]; p=0·0013).
INTERPRETATION


Patients with non-metastatic, castration-resistant prostate cancer receiving enzalutamide had longer metastasis-free survival than did those who received placebo, while maintaining low pain levels and prostate cancer symptom burden and high health-related quality of life. Enzalutamide showed a clinical benefit by delaying pain progression, symptom worsening, and decrease in functional status, compared with placebo. These findings suggest that enzalutamide is a treatment option that should be discussed with patients presenting with high-risk, non- metastatic, castration-resistant prostate cancer.
FUNDING


Astellas Pharma Inc, Medivation LLC (a Pfizer Company).",2019,p=0·028); there was no significant difference for BPI-SF item 3 or pain interference.,"['Patients with non-metastatic, castration-resistant prostate cancer receiving', 'patients aged 18 years or older with non-metastatic, castration-resistant prostate cancer and a prostate-specific antigen doubling time of up to 10 months', '1401 patients', 'patients presenting with high-risk, non- metastatic, castration-resistant prostate cancer', 'Between Nov 26, 2013, and June 28, 2017', '0·69', 'men with non-metastatic, castration-resistant prostate cancer (PROSPER', 'patients with non-metastatic, castration-resistant prostate cancer']","['enzalutamide versus placebo', 'interactive voice web recognition system to receive oral enzalutamide', 'placebo', '33·15', 'enzalutamide', 'enzalutamide or placebo', 'Enzalutamide']","['EORTC QLQ-PR25 urinary symptoms', 'metastasis-free survival', 'pain progression, symptom worsening, and decrease in functional status', 'BPI-SF pain severity', 'Time to clinically meaningful pain progression', 'clinically meaningful health-related quality of life as assessed by FACT-P total score', 'bowel symptoms', 'emotional wellbeing (36·73', 'low pain levels and prostate cancer symptom burden and high health-related quality of life', 'BPI-SF item 3 or pain interference', 'FACT-P scores', 'Time to deterioration of EQ-VAS', 'prostate cancer subscale (18·43', 'pain progression (assessed by the Brief Pain Inventory Short Form [BPI-SF] questionnaire) and health-related quality of life (assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-PR25], the EuroQoL 5-Dimensions 5-Levels health questionnaire visual analogue scale [EQ-5D-FL, EQ-VAS], and the Functional Assessment of Cancer Therapy-Prostate [FACT-P] questionnaires']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1328504', 'cui_str': 'Castration-resistant prostate cancer'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0426359', 'cui_str': 'Urinary symptoms (finding)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451149', 'cui_str': 'EORTC - Quality of life questionnaire'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}]",1401.0,0.730286,p=0·028); there was no significant difference for BPI-SF item 3 or pain interference.,"[{'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Tombal', 'Affiliation': 'Cliniques Universitaires Saint-Luc, Université catholique de Louvain, Brussels, Belgium. Electronic address: bertrand.tombal@uclouvain.be.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': ""Centre hospitalier de l'Université de Montréal/CRCHUM, Montreal, Quebec, Canada.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Penson', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'Northwestern University Robert H Lurie Comprehensive Cancer Center, Chicago, IL, USA.'}, {'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': 'Weill Cornell Medical Center, New York, NY, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Morlock', 'Affiliation': 'Astellas Pharma Inc, Northbrook, IL, USA.'}, {'ForeName': 'Krishnan', 'Initials': 'K', 'LastName': 'Ramaswamy', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Ivanescu', 'Affiliation': 'IQVIA, Amsterdam, Netherlands.'}, {'ForeName': 'Gerhardt', 'Initials': 'G', 'LastName': 'Attard', 'Affiliation': 'University College London Cancer Institute, London, UK.'}]",The Lancet. Oncology,['10.1016/S1470-2045(18)30898-2']
1384,31605797,A Randomized Phase 2 Study of Gefitinib With or Without Pemetrexed as First-line Treatment in Nonsquamous NSCLC With EGFR Mutation: Final Overall Survival and Biomarker Analysis.,"INTRODUCTION


Clinical studies have shown that a combination of a tyrosine kinase inhibitor (TKI) and pemetrexed overcame acquired resistance to epidermal growth factor receptor (EGFR) TKI in NSCLC. Previously, pemetrexed+gefintib (P+G) had improved progression-free survival (PFS) compared with gefitinib. We present OS, updated PFS, biomarker analysis, and safety of P+G versus gefitinib.
METHODS


This was a phase 2, multicenter, randomized study conducted in East Asian patients with advanced nonsquamous NSCLC with EGFR mutations. Patients were randomized (2:1) to receive P+G (500 mg/m 2  intravenously 3-weekly + 250 mg/day orally) or gefitinib.
RESULTS


In total, 191 patients (P+G, n=126; gefitinib, n=65) comprised the intent-to-treat and safety populations. Median OS was 43.4 months in P+G versus 36.8 months in gefitinib arm; adjusted HR 0.77 (95% CI, 0.5-1.2); one-sided P=0.105. Median PFS was significantly longer in the P+G (16.2 months) versus gefitinib arm (11.1 months); adjusted HR 0.67 (95% CI, 0.5-0.9); one-sided P=0.009. In the P+G and gefitinib arms, median PFS was 22.6 and 11.0 months, respectively, in patients with low thymidylate synthase (TS) expression, and 12.6 and 9.9 months, respectively, in patients with high TS expression. Common second-line post-discontinuation systemic therapies were EGFR-TKIs and chemotherapy. Most patients experienced at least one adverse event.
CONCLUSIONS


Addition of pemetrexed to EGFR TKI gefitinib resulted in significantly improved PFS and numerically longer OS compared with gefitinib in treatment-naïve patients with EGFR-mutated advanced nonsquamous NSCLC. Low TS expression appeared to be a good predictor for treatment outcomes.",2020,,['Nonsquamous Non-Small Cell Lung Cancer With EGFR Mutation'],['Gefitinib With or Without Pemetrexed'],[],"[{'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}]","[{'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}]",[],,0.103367,,"[{'ForeName': 'James Chih-Hsin', 'Initials': 'JC', 'LastName': 'Yang', 'Affiliation': 'National Taiwan University Hospital, Taipei, Taiwan. Electronic address: chihyang@ntu.edu.tw.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Jilin Provincial Cancer Hospital, Changchun, China.'}, {'ForeName': 'Haruyasu', 'Initials': 'H', 'LastName': 'Murakami', 'Affiliation': 'Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Pan-Chyr', 'Initials': 'PC', 'LastName': 'Yang', 'Affiliation': 'National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Jianxing', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'The First Affiliated Hospital of Guangzhou Medical College, Guangzhou, China.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Kindai University Faculty of Medicine, Osaka, Japan.'}, {'ForeName': 'Jin Hyoung', 'Initials': 'JH', 'LastName': 'Kang', 'Affiliation': 'The Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Joo-Hang', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'CHA Bundang Medical Center, CHA University, Gyeonggi-do, Korea.'}, {'ForeName': 'Rebecca R', 'Initials': 'RR', 'LastName': 'Hozak', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Tuan Stevon', 'Initials': 'TS', 'LastName': 'Nguyen', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Wan Li', 'Initials': 'WL', 'LastName': 'Zhang', 'Affiliation': 'Eli Lilly China, Shanghai, China.'}, {'ForeName': 'Sotaro', 'Initials': 'S', 'LastName': 'Enatsu', 'Affiliation': 'Eli Lilly Japan K.K., Kobe, Japan.'}, {'ForeName': 'Tarun', 'Initials': 'T', 'LastName': 'Puri', 'Affiliation': 'Eli Lilly and Company, Gurgaon, Haryana, India.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Orlando', 'Affiliation': 'Instituto Alexander Fleming, Buenos Aires, Argentina.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2019.09.008']
1385,30341035,Differences in Amino Acid Loss Between High-Efficiency Hemodialysis and Postdilution and Predilution Hemodiafiltration Using High Convection Volume Exchange-A New Metabolic Scenario? A Pilot Study.,"OBJECTIVE


The objective of the study was to quantify the loss of total amino acids (TAAs), nonessential amino acids, essential amino acids, and branched chain amino acids (BCAAs) produced by high-efficiency hemodialysis (HEHD), postdilution hemodiafiltration (HDFpost), and predilution hemodiafiltration (HDFpre) using high ultrafiltration volumes; and to define the specific AA losses registered in HEHD, HDFpost, and HDFpre; to identify a potential metabolic and nutritional decline into protein energy wasting; to compare AA analysis of arterial blood samples taken from healthy controls and patients with end-stage renal disease undergoing hemodialysis.
DESIGN AND METHODS


Identical dialysis monitors, membranes, and dialysate/infusate were used to homogenize extracorporeal body influence. Ten patients were recruited and randomized to receive treatment with HEHD, HDFpost, and HDFpre it was used on-line dialytic water methodologies (OL); patients' AA arterial concentrations were measured at the start and on completion of dialysis; TAA from the dialyzer filter was calculated, and baseline levels were subsequently compared with findings obtained 1 year later. Finally, the results obtained were compared with the data from a study of 8 healthy volunteers conducted using bioimpedance analysis and laboratory blood tests to assess nutritional status.
RESULTS


A higher convective dose results in a higher weekly loss of TAA, nonessential AAs, essential AAs, and BCAAs (HEHD: 15.7 g; HDFpost-OL: 16.1 g; HDFpre-OL: 16.3 g, P < .01). After 12 months, the same hemodialys patients showed a reduced body and water intracellular mass and reduced phase angle. Arterial concentrations of TAAs and BCAAs were lower than those detected in healthy subjects (P < .01).
CONCLUSION


The study shows that the AA losses in dialytic liquid are greater after high exchange volume HDF techniques, especially HDFpre. The AA losses are not metabolically compensated, so these increase the derangements of predialytic arterial plasma AA levels. Both AA losses and arterial AA perturbations further worsened body composition already after 12 months of additional dialysis.",2019,"Arterial concentrations of TAAs and BCAAs were lower than those detected in healthy subjects (P < .01).
","['8 healthy volunteers', 'healthy controls and patients with end-stage renal disease undergoing hemodialysis']","['Postdilution and Predilution Hemodiafiltration', 'HEHD, HDFpost, and HDFpre']","['TAA, nonessential AAs, essential AAs, and BCAAs (HEHD', 'Arterial concentrations of TAAs and BCAAs', 'predialytic arterial plasma AA levels', 'total amino acids (TAAs), nonessential amino acids, essential amino acids, and branched chain amino acids (BCAAs', 'AA arterial concentrations', 'reduced body and water intracellular mass and reduced phase angle', 'Amino Acid Loss']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}]","[{'cui': 'C0205224', 'cui_str': 'Essential (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0311461', 'cui_str': 'Nonessential amino acid'}, {'cui': 'C0002525', 'cui_str': 'Amino Acids, Essential'}, {'cui': 'C0002521', 'cui_str': 'Amino Acids, Branched-Chain'}, {'cui': 'C0333779', 'cui_str': 'Reducing bodies (morphologic abnormality)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0178719', 'cui_str': 'Intracellular (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}]",8.0,0.0300653,"Arterial concentrations of TAAs and BCAAs were lower than those detected in healthy subjects (P < .01).
","[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Murtas', 'Affiliation': 'Territorial Department of Nephrology and Dialysis, ASSL Cagliari, Cagliari, Italy; Department of Biology and Biotechnology, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Aquilani', 'Affiliation': 'Territorial Department of Nephrology and Dialysis, ASSL Cagliari, Cagliari, Italy; Department of Biology and Biotechnology, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Maria Luisa', 'Initials': 'ML', 'LastName': 'Deiana', 'Affiliation': 'Former Director of Territorial, Department of Nephrology and Dialysis, ASL Cagliari, Cagliari, Italy; Member of Italian Society of Nephrology, Cagliari, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Iadarola', 'Affiliation': 'Former Director of Territorial, Department of Nephrology and Dialysis, ASL Cagliari, Cagliari, Italy; Member of Italian Society of Nephrology, Cagliari, Italy.'}, {'ForeName': 'Romina', 'Initials': 'R', 'LastName': 'Secci', 'Affiliation': 'Former Director of Territorial, Department of Nephrology and Dialysis, ASL Cagliari, Cagliari, Italy; Member of Italian Society of Nephrology, Cagliari, Italy.'}, {'ForeName': 'Mariella', 'Initials': 'M', 'LastName': 'Cadeddu', 'Affiliation': 'Former Director of Territorial, Department of Nephrology and Dialysis, ASL Cagliari, Cagliari, Italy; Member of Italian Society of Nephrology, Cagliari, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Salis', 'Affiliation': 'Former Director of Territorial, Department of Nephrology and Dialysis, ASL Cagliari, Cagliari, Italy; Member of Italian Society of Nephrology, Cagliari, Italy.'}, {'ForeName': 'Doriana', 'Initials': 'D', 'LastName': 'Serpi', 'Affiliation': 'Former Director of Territorial, Department of Nephrology and Dialysis, ASL Cagliari, Cagliari, Italy; Member of Italian Society of Nephrology, Cagliari, Italy.'}, {'ForeName': 'Piergiorgio', 'Initials': 'P', 'LastName': 'Bolasco', 'Affiliation': 'Former Director of Territorial, Department of Nephrology and Dialysis, ASL Cagliari, Cagliari, Italy; Member of Italian Society of Nephrology, Cagliari, Italy. Electronic address: pg.bolasco@gmail.com.'}]",Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation,['10.1053/j.jrn.2018.07.005']
1386,30801267,Clown Intervention on Psychological Stress and Fatigue in Pediatric Patients With Cancer Undergoing Chemotherapy.,"BACKGROUND


Clown intervention has been shown to enhance emotional and behavioral processes, but few studies have comprehensively examined the effectiveness of this practice using biomarkers.
OBJECTIVE


The aim of this study was to evaluate the effect of a clown intervention on the levels of psychological stress and cancer-related fatigue in pediatric patients with cancer undergoing chemotherapy.
METHODS


Sixteen patients who met all criteria from a pediatric oncology inpatient unit in a Brazilian comprehensive cancer care hospital participated in this quasi-experimental study. Eight saliva samples were collected, comprising 4 at baseline and 4 after clown intervention (+1, +4, +9, and +13 hours after awakening). Salivary cortisol and α-amylase levels were determined using high-sensitivity enzyme-linked immunosorbent assay kits. Stress and fatigue were measured by the Child Stress Scale-ESI and the PedsQL Multidimensional Fatigue Scale, respectively. Relationships among stress, fatigue, and biomarker levels were investigated using nonparametric statistics.
RESULTS


In comparison with baseline measurements, the total psychological stress and fatigue levels improved after the clown intervention at the collection time point +4 hours (P = .003 and P = .04, respectively). Salivary cortisol showed a significant decrease after clown intervention at the collection time points +1, +9, and +13 hours (P < .05); however, α-amylase levels remained unchanged.
CONCLUSION


These findings provide preliminary evidence that clown intervention merits further study as a way to reduce stress and fatigue in pediatric cancer inpatients, and that self-report and biomarker measures are feasible to collect in this patient group.
IMPLICATIONS FOR PRACTICE


Clown intervention as a nonpharmacological intervention may improve stress and fatigue levels in pediatric inpatients with cancer undergoing chemotherapy.",2020,"In comparison with baseline measurements, the total psychological stress and fatigue levels improved after the clown intervention at the collection time point +4 hours (P = .003 and P = .04, respectively).","['pediatric inpatients with cancer undergoing chemotherapy', 'Sixteen patients who met all criteria from a pediatric oncology inpatient unit in a Brazilian comprehensive cancer care hospital participated in this quasi-experimental study', 'pediatric cancer inpatients', 'Pediatric Patients With Cancer Undergoing Chemotherapy', 'pediatric patients with cancer undergoing chemotherapy']","['Clown Intervention', 'clown intervention']","['stress, fatigue, and biomarker levels', 'Child Stress Scale-ESI and the PedsQL Multidimensional Fatigue Scale', 'stress and fatigue levels', 'Stress and fatigue', 'Psychological Stress and Fatigue', 'psychological stress and cancer-related fatigue', 'Salivary cortisol and α-amylase levels', 'Salivary cortisol', 'α-amylase levels', 'total psychological stress and fatigue levels']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1518931', 'cui_str': 'Pediatric oncology (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C2985410', 'cui_str': 'Clinical Trials, Nonrandomized'}]","[{'cui': 'C0335094', 'cui_str': 'Clown (occupation)'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0222045'}, {'cui': 'C0038443', 'cui_str': 'Stressor, Psychological'}, {'cui': 'C4274302', 'cui_str': 'Fatigue associated with malignant neoplastic disease'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0201883', 'cui_str': 'Amylase measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",16.0,0.0149199,"In comparison with baseline measurements, the total psychological stress and fatigue levels improved after the clown intervention at the collection time point +4 hours (P = .003 and P = .04, respectively).","[{'ForeName': 'Luis C', 'Initials': 'LC', 'LastName': 'Lopes-Junior', 'Affiliation': 'Author Affiliations: Department of Maternal-Infant Nursing and Public Health, University of São Paulo at Ribeirão Preto College of Nursing-PAHO/WHO Collaborating Centre for Nursing Research Development, Ribeirão Preto, São Paulo, Brazil (Drs Lopes-Júnior, Nascimento, Lima, and Pereira-da-Silva and Mr Alonso); Department of Biochemistry and Immunology, University of São Paulo at Ribeirão Preto Medical School, Graduate Program in Basic and Applied Immunology of the University of São Paulo at Ribeirão Preto Medical School, Ribeirão Preto, São Paulo, Brazil (Drs Silveira, Veronez, and Santos); Edmonton Clinic Health Academy, Faculty of Nursing, University of Alberta, Edmonton, Alberta, Canada (Dr Olson); and Department of Community Health and Epidemiology, University of Saskatchewan, College of Medicine, Saskatoon, Saskatchewan, Canada (Ms Bomfim).'}, {'ForeName': 'Denise S C', 'Initials': 'DSC', 'LastName': 'Silveira', 'Affiliation': ''}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Olson', 'Affiliation': ''}, {'ForeName': 'Emiliana O', 'Initials': 'EO', 'LastName': 'Bomfim', 'Affiliation': ''}, {'ForeName': 'Luciana C', 'Initials': 'LC', 'LastName': 'Veronez', 'Affiliation': ''}, {'ForeName': 'Jéssica C', 'Initials': 'JC', 'LastName': 'Santos', 'Affiliation': ''}, {'ForeName': 'Jonas B', 'Initials': 'JB', 'LastName': 'Alonso', 'Affiliation': ''}, {'ForeName': 'Lucila C', 'Initials': 'LC', 'LastName': 'Nascimento', 'Affiliation': ''}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Pereira-da-Silva', 'Affiliation': ''}, {'ForeName': 'Regina A G', 'Initials': 'RAG', 'LastName': 'Lima', 'Affiliation': ''}]",Cancer nursing,['10.1097/NCC.0000000000000690']
1387,30644628,"Pharmacokinetics of a novel, approved, 1.4-mg intranasal naloxone formulation for reversal of opioid overdose-a randomized controlled trial.","BACKGROUND AND AIMS


Intranasal (i.n.) naloxone is an established treatment for opioid overdose. Anyone likely to witness an overdose should have access to the antidote. We aimed to determine whether an i.n. formulation delivering 1.4 mg naloxone hydrochloride would achieve systemic exposure comparable to that of 0.8 mg intramuscular (i.m.) naloxone.
DESIGN


Open, randomized four-way cross-over trial.
SETTING


Clinical Trials Units in St Olav's Hospital, Trondheim and Rikshospitalet, Oslo, Norway.
PARTICIPANTS


Twenty-two healthy human volunteers, 10 women, median age = 25.8 years.
INTERVENTION AND COMPARATOR


One and two doses of i.n. 1.4 mg naloxone compared with i.m. 0.8 mg and intravenous (i.v.) 0.4 mg naloxone.
MEASUREMENTS


Quantification of plasma naloxone was performed by liquid chromatography tandem mass spectrometry. Pharmacokinetic non-compartment analyses were used for the main analyses. A non-parametric pharmacokinetic population model was developed for Monte Carlo simulations of different dosing scenarios.
FINDINGS


Area under the curve from administration to last measured concentration (AUC 0-last  ) for i.n. 1.4 mg and i.m. 0.8 mg were 2.62 ± 0.94 and 3.09 ± 0.64 h × ng/ml, respectively (P = 0.33). Maximum concentration (C max  ) was 2.36 ± 0.68 ng/ml for i.n. 1.4 mg and 3.73 ± 3.34 for i.m. 0.8 mg (P = 0.72). Two i.n. doses showed dose linearity and achieved a C max  of 4.18 ± 1.53 ng/ml. T max  was reached after 20.2 ± 9.4 minutes for i.n. 1.4 mg and 13.6 ± 15.4 minutes for i.m. 0.8 mg (P = 0.098). The absolute bioavailability for i.n. 1.4 mg was 0.49 (±0.24), while the relative i.n./i.m. bioavailability was 0.52 (±0.25).
CONCLUSION


Intranasal 1.4 mg naloxone provides adequate systemic concentrations to treat opioid overdose compared with intramuscular 0.8 mg, without statistical difference on maximum plasma concentration, time to maximum plasma concentration or area under the curve. Simulations support its appropriateness both as peer administered antidote and for titration of treatment by professionals.",2019,"overdose compared with intramuscular 0.8 mg, without statistical difference on maximum plasma concentration, time to maximum plasma concentration or area under the curve.","['Twenty-two healthy human volunteers, 10 women, median age\xa0=\xa025.8\xa0years', ""Clinical Trials Units in St Olav's Hospital, Trondheim and Rikshospitalet, Oslo, Norway""]","['naloxone', 'naloxone formulation', 'naloxone hydrochloride']","['absolute bioavailability', 'maximum plasma concentration, time to maximum plasma concentration or area under the curve', 'T max', 'bioavailability', 'Maximum concentration (C max  ']","[{'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}]","[{'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0700549', 'cui_str': 'Naloxone Hydrochloride'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",22.0,0.0692432,"overdose compared with intramuscular 0.8 mg, without statistical difference on maximum plasma concentration, time to maximum plasma concentration or area under the curve.","[{'ForeName': 'Arne Kristian', 'Initials': 'AK', 'LastName': 'Skulberg', 'Affiliation': 'Department of Circulation and Medical Imaging, NTNU, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Åsberg', 'Affiliation': 'Department of Pharmaceutical Biosciences, School of Pharmacy, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Hasse Zare', 'Initials': 'HZ', 'LastName': 'Khiabani', 'Affiliation': 'Department of Pharmacology, Oslo University Hospital-Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Røstad', 'Affiliation': 'DNE PHARMA AS, Oslo, Norway.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Tylleskar', 'Affiliation': 'Department of Circulation and Medical Imaging, NTNU, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Dale', 'Affiliation': 'Department of Circulation and Medical Imaging, NTNU, Norwegian University of Science and Technology, Trondheim, Norway.'}]","Addiction (Abingdon, England)",['10.1111/add.14552']
1388,31260642,"Promoting Breast Cancer Surveillance: The EMPOWER Study, a Randomized Clinical Trial in the Childhood Cancer Survivor Study.","PURPOSE


The aim of the current study was to increase the uptake of screening mammography among high-risk women who were treated for a childhood cancer with chest radiotherapy.
PATIENTS AND METHODS


Two hundred four female survivors in the Childhood Cancer Survivor Study who were treated with chest radiotherapy with 20 Gy or greater, age 25 to 50 years, and without breast imaging in the past 24 months were randomly assigned 2:1 to receive a mailed informational packet followed by a tailored telephone-delivered brief motivational interview (intervention) versus an attention control. Primary outcome was the difference in the proportion of participants who completed a screening mammogram by 12 months as evaluated in an intent-to-treat analysis. Stratum-adjusted relative risk (RR) and 95% CI were estimated using the Cochran-Mantel-Haenszel method. Secondary outcomes included the completion of screening breast magnetic resonance imaging (MRI) and barriers to screening and moderating factors.
RESULTS


Women in the intervention group were significantly more likely than those in the control group to report a mammogram (45 [33.1%] of 136  v  12 [17.6%] of 68; RR, 1.9; 95% CI, 1.1 to 3.3). The intervention was more successful among women age 25 to 39 years (RR, 2.2; 95% CI, 1.1 to 4.7) than among those age 40 to 50 years (RR, 1.4; 95% CI, 0.6 to 3.2). The proportion of women who reported a breast MRI at 12 months was similar between the two groups: 16.2% (intervention) compared with 13.2% (control; RR, 1.2; 95% CI, 0.6 to 2.5). Primary barriers to completing a screening mammogram and/or breast MRI included lack of physician recommendation, deferred action by survivor, cost, and absence of symptoms.
CONCLUSION


Use of mailed materials followed by telephone-delivered counseling increased mammography screening rates in survivors at high risk for breast cancer; however, this approach did not increase the rate of breast MRI. Cost of imaging and physician recommendation were important barriers that should be addressed in future studies.",2019,"The intervention was more successful among women age 25 to 39 years (RR, 2.2; 95% CI, 1.1 to 4.7) than among those age 40 to 50 years (RR, 1.4; 95% CI, 0.6 to 3.2).","['Two hundred four female survivors in the Childhood Cancer Survivor Study who were treated with chest radiotherapy with 20 Gy or greater, age 25 to 50 years, and without breast imaging in the past 24 months', 'Promoting Breast Cancer Surveillance', 'high-risk women who were treated for a childhood cancer with chest radiotherapy', 'survivors at high risk for breast cancer']","['telephone-delivered counseling', 'mailed informational packet followed by a tailored telephone-delivered brief motivational interview (intervention) versus an attention control']","['uptake of screening mammography', 'completion of screening breast magnetic resonance imaging (MRI) and barriers to screening and moderating factors', 'rate of breast MRI', 'lack of physician recommendation, deferred action by survivor, cost, and absence of symptoms', 'breast MRI', 'mammography screening rates']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C4047809', 'cui_str': 'At high risk for breast cancer'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C1641805', 'cui_str': 'Packet'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0203028', 'cui_str': 'Screening mammography (procedure)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]",204.0,0.106373,"The intervention was more successful among women age 25 to 39 years (RR, 2.2; 95% CI, 1.1 to 4.7) than among those age 40 to 50 years (RR, 1.4; 95% CI, 0.6 to 3.2).","[{'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Oeffinger', 'Affiliation': '1Duke University, Durham, NC.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Ford', 'Affiliation': '2Hunter College, City University of New York, New York, NY.'}, {'ForeName': 'Chaya S', 'Initials': 'CS', 'LastName': 'Moskowitz', 'Affiliation': '4Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Joanne F', 'Initials': 'JF', 'LastName': 'Chou', 'Affiliation': '4Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Tara O', 'Initials': 'TO', 'LastName': 'Henderson', 'Affiliation': '5The University of Chicago, Chicago, IL.'}, {'ForeName': 'Melissa M', 'Initials': 'MM', 'LastName': 'Hudson', 'Affiliation': ""6St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Diller', 'Affiliation': '7Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'McDonald', 'Affiliation': ""6St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Ford', 'Affiliation': ""6St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Nidha Z', 'Initials': 'NZ', 'LastName': 'Mubdi', 'Affiliation': '4Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Dayton', 'Initials': 'D', 'LastName': 'Rinehart', 'Affiliation': ""6St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Vukadinovich', 'Affiliation': ""6St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Gibson', 'Affiliation': ""6St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Nassim', 'Initials': 'N', 'LastName': 'Anderson', 'Affiliation': '4Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Elena B', 'Initials': 'EB', 'LastName': 'Elkin', 'Affiliation': '4Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Garrett', 'Affiliation': '8University of Colorado School of Public Health, Denver, CO.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Rebull', 'Affiliation': '9University of Vermont, Burlington, VT.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Leisenring', 'Affiliation': '10Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Leslie L', 'Initials': 'LL', 'LastName': 'Robison', 'Affiliation': ""6St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Gregory T', 'Initials': 'GT', 'LastName': 'Armstrong', 'Affiliation': ""6St Jude Children's Research Hospital, Memphis, TN.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00547']
1389,31702802,Bimodal Release Ondansetron for Acute Gastroenteritis Among Adolescents and Adults: A Randomized Clinical Trial.,"Importance


Vomiting resulting from acute gastroenteritis is commonly treated with intravenous antiemetics in acute care settings. If oral treatment were beneficial, patients might not need intravenous administered hydration or medication. Furthermore, a long-acting treatment could provide sustained relief from nausea and vomiting.
Objective


To determine whether an experimental long-acting bimodal release ondansetron tablet decreases gastroenteritis-related vomiting and eliminates the need for intravenous therapy for 24 hours after administration.
Design, Setting, and Participants


This placebo-controlled, double-blind, randomized clinical trial included patients from 19 emergency departments and 2 urgent care centers in the United States from December 8, 2014, to February 17, 2017. Patients 12 years and older with at least 2 vomiting episodes from presumed gastroenteritis in the previous 4 hours and symptoms with less than 36 hours' duration were randomized using a 3:2 active to placebo ratio. Analyses were performed on an intent-to-treat basis and conducted from June 1, 2017, to November 1, 2017.
Intervention


Bimodal release ondansetron tablet containing 6 mg of immediate release ondansetron and 18 mg of a 24-hour release matrix for a total of 24 mg of ondansetron.
Main Outcomes and Measures


Treatment success was defined as no further vomiting, no need for rescue medication, and no intravenous hydration for 24 hours after bimodal release ondansetron administration.
Results


Analysis included 321 patients (mean [SD] age, 29.0 [11.1] years; 195 [60.7%] women), with 192 patients in the bimodal release ondansetron group and 129 patients in the placebo group. Treatment successes were observed in 126 patients in the bimodal release ondansetron group (65.6%) compared with 70 patients in the placebo group (54.3%), with an 11.4% (95% CI, 0.3%-22.4%) absolute probability difference. The proportion of treatment success was 21% higher among patients who received bimodal release ondansetron compared with those who received a placebo (relative risk, 1.21; 95% CI, 1.00-1.46; P = .04). In an analysis including only patients with a discharge diagnosis of acute gastroenteritis and no major protocol violations, there were 123 treatment successes (69.5%) in the bimodal release ondansetron group compared with 67 treatment successes (54.9%) in the placebo group (relative risk, 1.27; 95% CI, 1.05-1.53; P = .01). Adverse effects were infrequent and similar to the known safety profile of ondansetron.
Conclusions and Relevance


This randomized clinical trial found that a long-acting bimodal release oral ondansetron tablet was an effective antiemetic among adolescents and adults with moderate to severe vomiting from acute gastroenteritis. The drug benefits extended to 24 hours after administration. Bimodal release ondansetron may decrease the need for intravenous access and emergency department care to manage acute gastroenteritis.
Trial Registration


ClinicalTrials.gov identifier: NCT02246439.",2019,"Treatment successes were observed in 126 patients in the bimodal release ondansetron group (65.6%) compared with 70 patients in the placebo group (54.3%), with an 11.4% (95% CI, 0.3%-22.4%) absolute probability difference.","['Adolescents and Adults', 'patients from 19 emergency departments and 2 urgent care centers in the United States from December 8, 2014, to February 17, 2017', 'adolescents and adults with moderate to severe vomiting from acute gastroenteritis', ""Patients 12 years and older with at least 2 vomiting episodes from presumed gastroenteritis in the previous 4 hours and symptoms with less than 36 hours' duration"", 'Acute Gastroenteritis', '321 patients (mean [SD] age, 29.0 [11.1] years; 195 [60.7%] women), with 192 patients in the bimodal release ondansetron group and 129 patients in the placebo group', '126 patients in the bimodal release']","['ondansetron', 'Bimodal Release Ondansetron', 'placebo', 'placebo ratio', 'ondansetron tablet containing 6 mg of immediate release ondansetron']","['vomiting, no need for rescue medication, and no intravenous hydration', 'discharge diagnosis of acute gastroenteritis and no major protocol violations', 'gastroenteritis-related vomiting', 'Adverse effects', 'proportion of treatment success']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C1551285', 'cui_str': 'Urgent Care Clinics'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0267446', 'cui_str': 'Acute gastroenteritis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0042965', 'cui_str': 'Vomitus (substance)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0017160', 'cui_str': 'Gastroenteritis'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1292426', 'cui_str': '4 hours (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}]","[{'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0267446', 'cui_str': 'Acute gastroenteritis'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0017160', 'cui_str': 'Gastroenteritis'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",321.0,0.535238,"Treatment successes were observed in 126 patients in the bimodal release ondansetron group (65.6%) compared with 70 patients in the placebo group (54.3%), with an 11.4% (95% CI, 0.3%-22.4%) absolute probability difference.","[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Silverman', 'Affiliation': 'Feinstein Institute for Medical Research, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, New York, New York.'}, {'ForeName': 'Stacey L', 'Initials': 'SL', 'LastName': 'House', 'Affiliation': 'Department of Emergency Medicine, Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Meltzer', 'Affiliation': 'School of Medicine and Health Sciences, Department of Emergency Medicine, George Washington University, Washington, DC.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Hahn', 'Affiliation': 'Department of Emergency Medicine, Northwell Health, New York, New York.'}, {'ForeName': 'Luis M', 'Initials': 'LM', 'LastName': 'Lovato', 'Affiliation': 'Department of Emergency Medicine, Olive View-UCLA Medical Center, Sylmar, California.'}, {'ForeName': 'Jahn', 'Initials': 'J', 'LastName': 'Avarello', 'Affiliation': 'Department of Emergency Medicine, Northwell Health, New York, New York.'}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Miller', 'Affiliation': 'Department of Emergency Medicine, Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'Ira N', 'Initials': 'IN', 'LastName': 'Kalfus', 'Affiliation': 'RedHill Biopharma, Tel-Aviv, Israel.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Fathi', 'Affiliation': 'RedHill Biopharma, Tel-Aviv, Israel.'}, {'ForeName': 'Gilead', 'Initials': 'G', 'LastName': 'Raday', 'Affiliation': 'RedHill Biopharma, Tel-Aviv, Israel.'}, {'ForeName': 'Terry F', 'Initials': 'TF', 'LastName': 'Plasse', 'Affiliation': 'RedHill Biopharma, Tel-Aviv, Israel.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Yan', 'Affiliation': 'Atlantic Research Group, Charlottesville, Virginia.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.14988']
1390,30803323,The feasibility of online video calling to engage patients with cystic fibrosis in exercise training.,"INTRODUCTION


Physical activity, including structured exercise, is an essential component in the management of cystic fibrosis. The use of telehealth such as video-calling may be a useful method for the delivery of exercise and physical activity interventions, though the feasibility of this remains unknown.
METHODS


Nine patients with cystic fibrosis (three female, six male, 30.9 ± 8.7 years) volunteered to participate. Participants completed an eight-week exercise training intervention conducted via Skype, using personalised exercises, with all sessions supervised by an exercise therapist. Feasibility was assessed by demand, implementation, practicality and acceptability. Changes in anthropometric, pulmonary, physical activity and quality of life variables were also assessed.
RESULTS


Two male participants withdrew from the study, citing lack of available time. The remaining participants found use of Skype useful, with a mean satisfaction rating of 9/10, and three participants requesting to continue the sessions beyond the duration of the study. Mean compliance with sessions was 68%, with mean duration of sessions being 20 min. A total of 25% of calls suffered from technical issues such as video or audio lags. Anthropometric, pulmonary, physical activity and quality of life variables remained unchanged over the course of the study period.
DISCUSSION


The use of Skype to deliver an exercise intervention to patients withcystic fibrosis was found to be technologically feasible, and acceptable among participants. Findings have implications for clinical practice and could allow care teams to engage patients remotely in exercise. Further research is required to assess the efficacy of this modality on increasing physical activity and associated health outcomes.",2019,"The use of Skype to deliver an exercise intervention to patients withcystic fibrosis was found to be technologically feasible, and acceptable among participants.","['Nine patients with cystic fibrosis (three female, six male, 30.9\u2009±\u20098.7 years) volunteered to participate', 'engage patients with cystic fibrosis in exercise training', 'Two male participants withdrew from the study, citing lack of available time']","['exercise training intervention conducted via Skype, using personalised exercises, with all sessions supervised by an exercise therapist', 'exercise intervention', 'online video calling']","['Anthropometric, pulmonary, physical activity and quality of life variables', 'Mean compliance', 'Changes in anthropometric, pulmonary, physical activity and quality of life variables', 'demand, implementation, practicality and acceptability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4517880', 'cui_str': '8.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034380'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",2.0,0.0180621,"The use of Skype to deliver an exercise intervention to patients withcystic fibrosis was found to be technologically feasible, and acceptable among participants.","[{'ForeName': 'Owen W', 'Initials': 'OW', 'LastName': 'Tomlinson', 'Affiliation': 'Department of Respiratory Medicine, Royal Devon and Exeter NHS Foundation Trust Hospital, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Shelley', 'Affiliation': 'Department of Respiratory Medicine, Royal Devon and Exeter NHS Foundation Trust Hospital, UK.'}, {'ForeName': 'Jayne', 'Initials': 'J', 'LastName': 'Trott', 'Affiliation': 'Department of Respiratory Medicine, Royal Devon and Exeter NHS Foundation Trust Hospital, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Bowhay', 'Affiliation': 'Department of Respiratory Medicine, Royal Devon and Exeter NHS Foundation Trust Hospital, UK.'}, {'ForeName': 'Rohan', 'Initials': 'R', 'LastName': 'Chauhan', 'Affiliation': 'Research and Development Directorate, Royal Devon and Exeter NHS Foundation Trust Hospital, UK.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Sheldon', 'Affiliation': 'Department of Respiratory Medicine, Royal Devon and Exeter NHS Foundation Trust Hospital, UK.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19828630']
1391,31469752,Fascia Iliaca Block Decreases Hip Fracture Postoperative Opioid Consumption: A Prospective Randomized Controlled Trial.,"OBJECTIVES


To determine the efficacy of a preoperative fascia iliaca compartment block in decreasing postoperative pain and improving functional recovery after hip fracture surgery.
DESIGN


Randomized prospective Level 1 therapeutic.
SETTING


Academic Level 1 trauma center.
PATIENTS


Geriatric patients with fractures of the proximal femur (neck, intertrochanteric, or subtrochanteric regions) were prospectively randomized into an experimental (A) or control (B) groups. Forty-seven patients met inclusion criteria, 23 randomized to the experimental group and 24 to the control group.
INTERVENTION


Patients randomized to the experimental group received an ultrasound-guided fascia iliaca compartment block administered by a board-certified anesthesiologist immediately before the initiation of anesthesia.
MAIN OUTCOME MEASUREMENTS


Primary outcome measure was postoperative pain medication consumption until postoperative day 3. Secondary outcomes included functional recovery and a study-specific patient-reported satisfaction survey assessed on postoperative day 3.
RESULTS


There was no significant difference in consumption of acetaminophen for mild pain, tramadol for moderate pain, or functional recovery between the 2 groups. There was a statistically significant decrease in morphine consumption (0.4 mg vs. 19.4 mg, P = 0.05) and increase in patient-reported satisfaction (31%, P = 0.01).
CONCLUSIONS


Preoperative fascia iliaca compartment block significantly decreases postoperative opioid consumption while improving patient satisfaction. We recommend the integration of this safe and efficacious modality into institutional geriatric hip fracture protocols as an adjunctive pain control strategy.
LEVEL OF EVIDENCE


Therapeutic Level II See Instructions for Authors for a complete description of levels of evidence.",2020,"There was a statistically significant decrease in Morphine consumption (0.4mg vs. 19.4mg, p=0.05) and increase in patient-reported satisfaction (31%, p=0.01).
","[' Geriatric patients with fractures of the proximal femur (neck, intertrochanteric or subtrochanteric regions', 'hip fracture surgery', 'Decreases Hip Fracture Postoperative Opioid Consumption', '47 patients met inclusion criteria, 23 randomized to the experimental group and 24 to the control group']","['preoperative Fasica Iliaca Compartment Block (FICB', 'Fascia Iliaca Block', 'ultrasound guided fascia iliaca compartment block administered by a board certified anesthesiologist immediately prior to the initiation of anesthesia']","['consumption of Acetaminophen for mild pain, Tramadol for moderate pain, or functional recovery', 'postoperative pain medication consumption until postoperative day three', 'functional recovery and a study-specific patient-reported satisfaction survey assessed on postoperative day three', 'postoperative opioid consumption', 'patient-reported satisfaction', 'Morphine consumption']","[{'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0278138', 'cui_str': 'Mild pain (finding)'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0278139', 'cui_str': 'Moderate pain (finding)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]",23.0,0.118488,"There was a statistically significant decrease in Morphine consumption (0.4mg vs. 19.4mg, p=0.05) and increase in patient-reported satisfaction (31%, p=0.01).
","[{'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'Departments of Orthopedics.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Long', 'Affiliation': 'Departments of Orthopedics.'}, {'ForeName': 'Eloise', 'Initials': 'E', 'LastName': 'Rogers', 'Affiliation': 'Departments of Orthopedics.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Pesso', 'Affiliation': 'Anesthesia, Nassau University Medical Center, East Meadow, NY.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Galos', 'Affiliation': 'Departments of Orthopedics.'}, {'ForeName': 'Rhyne Champ', 'Initials': 'RC', 'LastName': 'Dengenis', 'Affiliation': 'Departments of Orthopedics.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Ruotolo', 'Affiliation': 'Departments of Orthopedics.'}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001634']
1392,30782070,Effectiveness of telemonitoring-enhanced support over structured telephone support in reducing heart failure-related healthcare utilization in a multi-ethnic Asian setting.,"AIMS


Our study aimed to compare the effectiveness of telemonitoring over structured telephone support in reducing heart failure-related healthcare utilization.
METHODS


This was a non-randomised controlled study comparing 150 recently discharged heart failure patients enrolled into telemonitoring and 55 patients who only received structured telephone support after rejecting telemonitoring. Patient activation, knowledge and self-management levels were measured at baseline and the one year upon programme completion using the Patient Activation Measure, the Dutch Heart Failure Knowledge Scale and the Self-Care of Heart Failure Index respectively. Differences in heart failure-related and all-cause hospitalization rates, total bed days and mortality rates at 180 days and at one year, knowledge and self-management scores and total cost of care between groups at one year were analysed.
RESULTS


Average age of telemonitoring was 57.9 years and 63.9 years for structured telephone support. Significant difference in adjusted 180-day all-cause bed days (telemonitoring: five days versus structured telephone support: 9.8 days), heart failure-related bed days (telemonitoring: 1.2 days versus structured telephone support: six days) and adjusted one-year heart failure-related bed days (telemonitoring: 2.2 days versus structured telephone support: 6.6 days) were observed. Telemonitoring was associated with reduced all-cause one-year mortality (hazard ratio 0.32,  p  = 0.02). Estimated mean maintenance and confidence scores were significantly higher in the telemonitoring group at one year. No differences in all-cause and HF-related readmission rates and knowledge levels were observed. The one-year total cost of care was predicted to be Singapore dollars (SG$) 2774.4 lower ( p  = 0.07) in telemonitoring.
CONCLUSION


In conclusion, telemonitoring was associated with lower all-cause and heart failure-related total bed days at 180 days, lower heart failure-related total bed days and total cost of care at one year as compared with structured telephone support.",2019,"Telemonitoring was associated with reduced all-cause one-year mortality (hazard ratio 0.32, p = 0.02).","['Average age of telemonitoring was 57.9 years and 63.9 years for structured telephone support', 'a multi-ethnic Asian setting', '150 recently discharged heart failure patients enrolled into telemonitoring and 55 patients who only received']","['telemonitoring over structured telephone support', 'structured telephone support after rejecting telemonitoring', 'telemonitoring-enhanced support over structured telephone support']","['Patient activation, knowledge and self-management levels', 'knowledge and self-management scores and total cost of care', 'heart failure', 'Dutch Heart Failure Knowledge Scale and the Self-Care of Heart Failure Index respectively', 'heart failure-related and all-cause hospitalization rates, total bed days and mortality rates', 'heart failure-related healthcare utilization', 'Estimated mean maintenance and confidence scores', 'Singapore dollars (SG', 'heart failure-related total bed days and total cost of care', 'cause and HF-related readmission rates and knowledge levels']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C4319517', 'cui_str': 'Order rejected (qualifier value)'}]","[{'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0222045'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0871796', 'cui_str': 'Knowledge level'}]",150.0,0.0585862,"Telemonitoring was associated with reduced all-cause one-year mortality (hazard ratio 0.32, p = 0.02).","[{'ForeName': 'Wai', 'Initials': 'W', 'LastName': 'Leng Chow', 'Affiliation': 'Changi General Hospital, Singapore.'}, {'ForeName': 'Chaw Yu K', 'Initials': 'CYK', 'LastName': 'Aung', 'Affiliation': 'Changi General Hospital, Singapore.'}, {'ForeName': 'Shao Chuen', 'Initials': 'SC', 'LastName': 'Tong', 'Affiliation': 'Changi General Hospital, Singapore.'}, {'ForeName': 'Geraldine Sl', 'Initials': 'GS', 'LastName': 'Goh', 'Affiliation': 'Changi General Hospital, Singapore.'}, {'ForeName': 'Sheldon', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Changi General Hospital, Singapore.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'MacDonald', 'Affiliation': 'Changi General Hospital, Singapore.'}, {'ForeName': 'Angela Nk', 'Initials': 'AN', 'LastName': 'Ng', 'Affiliation': 'Changi General Hospital, Singapore.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Changi General Hospital, Singapore.'}, {'ForeName': 'Atikah E', 'Initials': 'AE', 'LastName': 'Ahmad', 'Affiliation': 'Changi General Hospital, Singapore.'}, {'ForeName': 'Mei Foon', 'Initials': 'MF', 'LastName': 'Yap', 'Affiliation': 'Changi General Hospital, Singapore.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Leong', 'Affiliation': 'Thomson Medical Centre Hospital, Singapore.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Bruege', 'Affiliation': 'Philips Population Health Management, Germany.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Tesanovic', 'Affiliation': 'Philips Research, Eindhoven, The Netherlands.'}, {'ForeName': 'Jarno', 'Initials': 'J', 'LastName': 'Riistama', 'Affiliation': 'Philips Research, Eindhoven, The Netherlands.'}, {'ForeName': 'Sze Yunn', 'Initials': 'SY', 'LastName': 'Pang', 'Affiliation': 'Health Informatics and Population Management, Philips ASEAN Pacific, Singapore.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Erazo', 'Affiliation': 'Health Informatics and Population Management, Philips ASEAN Pacific, Singapore.'}]",Journal of telemedicine and telecare,['10.1177/1357633X18825164']
1393,31605792,Programmed Cell Death Ligand 1 Expression in Untreated EGFR Mutated Advanced NSCLC and Response to Osimertinib Versus Comparator in FLAURA.,"INTRODUCTION


EGFR mutated (EGFRm) NSCLC tumors occasionally express programmed cell death ligand 1 (PD-L1), although frequency and clinical relevance are not fully characterized. We report PD-L1 expression in patients with EGFRm advanced NSCLC and association with clinical outcomes following treatment with osimertinib or comparator EGFR tyrosine kinase inhibitors in the FLAURA trial (phase III, NCT02296125).
METHODS


Of 231 tissue blocks available from the screened population (including EGFRm-positive and -negative samples), 197 had sufficient tissue for PD-L1 testing using the SP263 (Ventana, Tucson, Arizona) immunohistochemical assay. Tumor cell (TC) staining thresholds of PD-L1 TC greater than or equal to 1%, TC greater than or equal to 25%, and TC greater than or equal to 50% were applied. Progression-free survival (PFS) was investigator-assessed, per Response Evaluation Criteria in Solid Tumor, version 1.1, according to PD-L1 expressors (TC ≥ 1%) or negatives (TC < 1%) in randomized patients.
RESULTS


PD-L1 staining was successful in 193 of 197 patient formalin-fixed paraffin-embedded blocks; of these, 128 of 193 were EGFRm-positive and 106 of 128 patients were randomized to treatment (osimertinib: 54; comparator: 52). At the PD-L1 TC greater than or equal to 25% threshold, 8% (10 of 128) of EGFRm-positive tumors expressed PD-L1 versus 35% (23 of 65) of EGFRm-negative tumors. With the TC greater than or equal to 1% threshold, 51% (65 of 128) versus 68% (44 of 65) were mutation-positive and -negative, respectively, and with the TC greater than or equal to 50% threshold, 5% (7 of 128) versus 28% (18 of 65), were mutation-positive and -negative, respectively. For PD-L1 expressors (TC ≥ 1%), median PFS was 18.4 months with osimertinib and 6.9 months with comparator (hazard ratio = 0.30; 95% confidence interval: 0.15-0.60). For PD-L1-negative patients (TC < 1%), median PFS was 18.9 months with osimertinib and 10.9 months with comparator (hazard ratio = 0.37; 95% confidence interval: 0.17-0.74).
CONCLUSIONS


Clinical benefit with osimertinib was unaffected by PD-L1 expression status.",2020,", 197 had sufficient tissue for PD-L1 testing using the SP263 (Ventana) immunohistochemical assay.","['Of 231 tissue blocks available from the screened population (including EGFRm positive and negative samples', 'patients with EGFRm advanced NSCLC']",['Epidermal growth factor receptor mutated (EGFRm'],"['median PFS', 'Progression-free survival (PFS']","[{'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C0034802', 'cui_str': 'c-erbB-1 Protein'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",231.0,0.0437835,", 197 had sufficient tissue for PD-L1 testing using the SP263 (Ventana) immunohistochemical assay.","[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Brown', 'Affiliation': 'Precision Medicine, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Vansteenkiste', 'Affiliation': 'Respiratory Oncology Unit (Respiratory Diseases), University Hospital KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Cobo', 'Affiliation': 'Medical Oncology Department, University Regional Hospital of Málaga, IBIMA, Málaga, Spain.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'John', 'Affiliation': 'Olivia Newton-John Cancer Research Institute, Austin Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Barker', 'Affiliation': 'Precision Medicine, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kohlmann', 'Affiliation': 'Precision Medicine, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Todd', 'Affiliation': 'Oncology Biometrics, Oncology, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Matilde', 'Initials': 'M', 'LastName': 'Saggese', 'Affiliation': 'Global Medicines Development, Oncology, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Juliann', 'Initials': 'J', 'LastName': 'Chmielecki', 'Affiliation': 'Translational Medicine, Oncology, AstraZeneca, Waltham, Massachusetts.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Markovets', 'Affiliation': 'Translational Medicine, Oncology, AstraZeneca, Waltham, Massachusetts.'}, {'ForeName': 'Marietta', 'Initials': 'M', 'LastName': 'Scott', 'Affiliation': 'Precision Medicine, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Suresh S', 'Initials': 'SS', 'LastName': 'Ramalingam', 'Affiliation': 'Emory University School of Medicine, Winship Cancer Institute, Atlanta, Georgia. Electronic address: suresh.ramalingam@emory.edu.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2019.09.009']
1394,30582271,A randomized multicenter study on ambulatory blood pressure and arterial stiffness in patients treated with valsartan/amlodipine or nifedipine GITS.,"In a pre-specified subgroup analysis of a 12-week randomized multicenter study, we investigated effects of valsartan/amlodipine 80/5 mg single-pill combination (n = 75) and nifedipine GITS 30 mg (n = 75) on ambulatory blood pressure (BP) and arterial stiffness assessed by brachial-ankle pulse wave velocity (PWV) in patients with uncontrolled hypertension. At week 12, the between-treatment mean differences in systolic/diastolic BP were smaller for 24-hour and daytime (-2.1/-1.7 and -2.0/-1.5 mm Hg, respectively, P ≥ 0.22) but greater (P < 0.01) for nighttime (-4.0/-2.8 mm Hg, P ≤ 0.09), especially in sustained uncontrolled hypertension (-5.0/-4.1 mm Hg, P ≤ 0.04) and non-dippers (-6.5/-3.7 mm Hg, P ≤ 0.07), in favor of valsartan/amlodipine. At week 12, PWV was significantly reduced from baseline by valsartan/amlodipine (n = 59, P < 0.0001) but not nifedipine (n = 59, P = 0.06). The changes in PWV were significantly associated with that in ambulatory systolic BP and pulse pressure in the nifedipine (P ≤ 0.0008) but not valsartan/amlodipine group (P ≥ 0.57), with a significant interaction (P ≤ 0.045). The valsartan/amlodipine combination was more efficacious than nifedipine GITS in lowering nighttime BP in sustained uncontrolled hypertension and non-dippers, and in lowering arterial stiffness independent of BP lowering.",2019,"The valsartan/amlodipine combination was more efficacious than nifedipine GITS in lowering nighttime BP in sustained uncontrolled hypertension and non-dippers, and in lowering arterial stiffness independent of BP lowering.","['patients with uncontrolled hypertension', 'patients treated with']","['nifedipine GITS', 'nifedipine', 'valsartan/amlodipine', 'valsartan/amlodipine or nifedipine GITS', 'valsartan/amlodipine 80/5\xa0mg single-pill combination']","['changes in PWV', 'systolic/diastolic BP', 'PWV', 'ambulatory blood pressure and arterial stiffness', 'sustained uncontrolled hypertension', 'ambulatory blood pressure (BP) and arterial stiffness assessed by brachial-ankle pulse wave velocity (PWV', 'nighttime', 'ambulatory systolic BP and pulse pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0028066', 'cui_str': 'Nifedipine'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0445456', 'cui_str': 'Brachial (qualifier value)'}, {'cui': 'C0232154', 'cui_str': 'Ankle pulse'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}]",75.0,0.0474289,"The valsartan/amlodipine combination was more efficacious than nifedipine GITS in lowering nighttime BP in sustained uncontrolled hypertension and non-dippers, and in lowering arterial stiffness independent of BP lowering.","[{'ForeName': 'Shao-Kun', 'Initials': 'SK', 'LastName': 'Xu', 'Affiliation': 'Department of Hypertension, Centre for Epidemiological Studies and Clinical Trials, Shanghai Key Laboratory of Hypertension, The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Qi-Fang', 'Initials': 'QF', 'LastName': 'Huang', 'Affiliation': 'Department of Hypertension, Centre for Epidemiological Studies and Clinical Trials, Shanghai Key Laboratory of Hypertension, The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Wei-Fang', 'Initials': 'WF', 'LastName': 'Zeng', 'Affiliation': 'Department of Hypertension, Centre for Epidemiological Studies and Clinical Trials, Shanghai Key Laboratory of Hypertension, The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Chang-Sheng', 'Initials': 'CS', 'LastName': 'Sheng', 'Affiliation': 'Department of Hypertension, Centre for Epidemiological Studies and Clinical Trials, Shanghai Key Laboratory of Hypertension, The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Hypertension, Centre for Epidemiological Studies and Clinical Trials, Shanghai Key Laboratory of Hypertension, The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Ji-Guang', 'Initials': 'JG', 'LastName': 'Wang', 'Affiliation': 'Department of Hypertension, Centre for Epidemiological Studies and Clinical Trials, Shanghai Key Laboratory of Hypertension, The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13457']
1395,31701388,You-Me-Us: Results of a Cluster Randomized Trial of a Healthy Relationships Approach to Sexual Risk Reduction.,"By middle adolescence, most young people have been involved in at least one romantic relationship, a context in which many sexual interactions occur. Indeed, researchers have suggested the importance of attending to relationships in programs focused on sexual risk, yet few evidence-based programs have a strong relationships focus. Our study examined the impact of a healthy relationship program called You-Me-Us that included a classroom curriculum and a school-wide peer norms approach. We evaluated the intervention using a small group randomized trial that included nine participating urban middle schools (defined as schools that include grades 6-8) in three urban school districts. We invited all 7th grade students within the study schools to enroll. Students completed three surveys during 7th and 8th grades (baseline plus two follow up surveys at 6 and 18 months following baseline). A total of 911 youth with positive consent and assent were enrolled in the study. Follow up survey response rates among those taking the baseline were 92% at 6 months and 80% at 18 months. Multilevel regression models were used to adjust for the correlation among students within the same school, and the correlation of repeated measurements taken on the same student over time. The intervention reduced vaginal sexual initiation by about half at the 6-month follow-up, and this approached significance. Further, youth in the intervention condition were less likely to believe it is okay for people their age to have vaginal sex without using condoms if the girl is on birth control. None of the remaining variables differed significantly by intervention condition. This study provides insights on using a healthy relationship approach for younger urban adolescents. This approach produced a programmatically significant reduction in sexual initiation that did not reach standard levels of statistical significance, and warrants further exploration.",2019,"This approach produced a programmatically significant reduction in sexual initiation that did not reach standard levels of statistical significance, and warrants further exploration.","['911 youth with positive consent and assent were enrolled in the study', 'nine participating urban middle schools (defined as schools that include grades 6-8) in three urban school districts', 'younger urban adolescents', 'We invited all 7th grade students within the study schools to enroll']",['healthy relationship program called You-Me'],['vaginal sexual initiation'],"[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3539085', 'cui_str': 'All'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}]",911.0,0.0280348,"This approach produced a programmatically significant reduction in sexual initiation that did not reach standard levels of statistical significance, and warrants further exploration.","[{'ForeName': 'Karin K', 'Initials': 'KK', 'LastName': 'Coyle', 'Affiliation': 'ETR, 100 Enterprise Way, Suite G300, Scotts Valley, CA, 95066, USA. karin.coyle@etr.org.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Anderson', 'Affiliation': 'ETR, 100 Enterprise Way, Suite G300, Scotts Valley, CA, 95066, USA.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Franks', 'Affiliation': 'ETR, 100 Enterprise Way, Suite G300, Scotts Valley, CA, 95066, USA.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Walker', 'Affiliation': 'ETR, 1630 San Pablo Ave., Suite 500, Oakland, CA, 94612, USA.'}, {'ForeName': 'Jill R', 'Initials': 'JR', 'LastName': 'Glassman', 'Affiliation': 'ETR, 100 Enterprise Way, Suite G300, Scotts Valley, CA, 95066, USA.'}]",The journal of primary prevention,['10.1007/s10935-019-00569-w']
1396,30770244,Comparison of intravenous lidocaine/ketorolac combination to either analgesic alone for suspected renal colic pain in the ED.,"STUDY OBJECTIVE


To compare analgesic efficacy and safety of intravenous lidocaine and ketorolac combination to each analgesic alone for ED patients with suspected renal colic.
METHODS


We conducted a randomized, double-blind trial comparing analgesic efficacy of a combination of intravenous lidocaine (1.5 mg/kg) and ketorolac (30 mg), to ketorolac (30 mg), and to lidocaine (1.5 mg/kg) in patients aged 18-64 presenting to the ED with suspected renal colic. Primary outcome included difference in pain scores between the groups at 30 min. Secondary outcomes included a comparative reduction in pain scores in each group from baseline to 30 and 60 min as well as rates of adverse events and need for rescue analgesia at 30 and 60 min.
RESULTS


We enrolled 150 subjects (50 per group). The difference in mean pain scores at 30 min between Lidocaine and Lidocaine/Ketorolac groups was -2.89 (95% CI: -4.39 to -1.39); between Ketorolac and Lidocaine/Ketorolac group was -0.92 (95% CI: -2.44 to 0.61); and between Ketorolac and Lidocaine was -1.98 (95% CI: -3.69 to -0.27). A comparative percentage of subjects in each group required rescue analgesia at 30 and 60 min. No clinically concerning changes in vital signs were observed. No serious adverse events occurred in either group. Commonly reported adverse effects were dizziness, nausea, and headache.
CONCLUSION


The administration of intravenous lidocaine/ketorolac combination to ED patients with suspected renal colic results in better analgesia in comparison to lidocaine alone but provides no analgesic advantages over ketorolac alone. Clinicaltrials.gov Registration: NCT02902770.",2020,The difference in mean pain scores at 30 min between Lidocaine and Lidocaine/Ketorolac groups was -2.89,"['ED patients with suspected renal colic', 'We enrolled 150 subjects (50 per group', 'patients aged 18-64 presenting to the ED with suspected renal colic']","['Ketorolac', 'Lidocaine', 'lidocaine', 'lidocaine and ketorolac combination', 'ketorolac', 'analgesic alone', 'lidocaine/ketorolac', 'Lidocaine/Ketorolac', 'intravenous lidocaine']","['comparative reduction in pain scores', 'mean pain scores', 'rescue analgesia', 'rates of adverse events and need for rescue analgesia at 30 and 60\u202fmin', 'suspected renal colic pain', 'analgesic efficacy and safety', 'pain scores', 'vital signs', 'dizziness, nausea, and headache', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0152169', 'cui_str': 'Acute Renal Colic'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1704764', 'cui_str': 'Per'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]","[{'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0152169', 'cui_str': 'Acute Renal Colic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0518766'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}]",150.0,0.368904,The difference in mean pain scores at 30 min between Lidocaine and Lidocaine/Ketorolac groups was -2.89,"[{'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Motov', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Catsim', 'Initials': 'C', 'LastName': 'Fassassi', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Jefferson', 'Initials': 'J', 'LastName': 'Drapkin', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, NY, USA. Electronic address: jdrapkin@maimonidesmed.org.'}, {'ForeName': 'Mahlaqa', 'Initials': 'M', 'LastName': 'Butt', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Rukhsana', 'Initials': 'R', 'LastName': 'Hossain', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Likourezos', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Monfort', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Brady', 'Affiliation': 'Department of Pharmacy, Maimonides Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Nechama', 'Initials': 'N', 'LastName': 'Rothberger', 'Affiliation': 'Department of Pharmacy, Maimonides Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Stefan S', 'Initials': 'SS', 'LastName': 'Mann', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Flom', 'Affiliation': 'Peter Flom Consulting, New York, USA.'}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Gulati', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, NY, USA.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.01.048']
1397,30795951,"Adjuvant denosumab in postmenopausal patients with hormone receptor-positive breast cancer (ABCSG-18): disease-free survival results from a randomised, double-blind, placebo-controlled, phase 3 trial.","BACKGROUND


In postmenopausal women with hormone receptor-positive, early-stage breast cancer, treatment with adjuvant aromatase inhibitors is the standard of care, but it increases risk for osteoporosis and fractures. Results from the ABCSG-18 trial showed that use of denosumab as an adjuvant to aromatase inhibitor therapy significantly reduced clinical fractures. Disease-free survival outcomes from ABCSG-18 have not yet been reported.
METHODS


Postmenopausal patients with early, hormone receptor-positive, non-metastatic adenocarcinoma of the breast, who had completed their initial adjuvant treatment pathway (surgery, radiotherapy, or chemotherapy, or a combination) and were receiving adjuvant aromatase inhibitors, were enrolled at 58 trial centres in Austria and Sweden into this prospective, double-blind, placebo-controlled, phase 3 trial. With permuted block randomisation (block sizes 2 and 4, stratified by previous aromatase inhibitor use, total lumbar spine bone mineral density score at baseline, and type of centre), patients were assigned (1:1) to receive subcutaneous denosumab (60 mg) or matching placebo every 6 months during aromatase inhibitor therapy. The primary endpoint (previously reported) was the time to first clinical fracture after randomisation. The secondary endpoint reported here is disease-free survival (defined as time from randomisation to first evidence of local or distant metastasis, contralateral breast cancer, secondary carcinoma, or death from any cause) in the intention-to-treat population. This study is registered with EudraCT (number 2005-005275-15) and ClinicalTrials.gov (number NCT00556374), and is ongoing for long-term follow-up.
FINDINGS


Between Dec 18, 2006, and July 22, 2013, 3425 eligible patients were enrolled and randomly assigned; 1711 to the denosumab group and 1709 to the placebo group (with five others withdrawing consent). After a median follow-up of 73 months (IQR 58-95), 240 (14·0%) patients in the denosumab and 287 (16·8%) in the placebo group had disease-free survival events. Disease-free survival was significantly improved in the denosumab group versus the placebo group (hazard ratio 0·82, 95% CI 0·69-0·98, Cox p=0·0260; descriptive analysis, without controlling for multiplicity). In the denosumab group, disease-free survival was 89·2% (95% CI 87·6-90·8) at 5 years and 80·6% (78·1-83·1) at 8 years of follow-up, compared with 87·3% (85·7-89·0) at 5 years and 77·5% (74·8-80·2) and 8 years in the placebo group. No independently adjudicated cases of osteonecrosis of the jaw or confirmed atypical femoral fractures were recorded. The total number of adverse events was similar in the denosumab group (1367 [including 521 serious] adverse events) and the placebo group (1339 [515 serious]). The most common serious adverse events were osteoarthritis (62 [3·6%] of 1709 in the denosumab group vs 58 [3·4%] of 1690 in the placebo group), meniscus injury (23 [1·3%] vs 24 [1·4%]), and cataract (16 [0·9%] vs 28 [1·7%]). One (<0·1%) treatment-related death (due to pneumonia, septic kidney failure, and cardiac decompensation) occurred in the denosumab group.
INTERPRETATION


Denosumab constitutes an effective and safe adjuvant treatment for patients with postmenopausal hormone receptor-positive early breast cancer receiving aromatase inhibitor therapy.
FUNDING


Amgen.",2019,"Disease-free survival was significantly improved in the denosumab group versus the placebo group (hazard ratio 0·82, 95% CI 0·69-0·98, Cox p=0·0260; descriptive analysis, without controlling for multiplicity).","['postmenopausal women with hormone receptor-positive, early-stage breast cancer', 'postmenopausal patients with hormone receptor-positive breast cancer (ABCSG-18', 'Postmenopausal patients with early, hormone receptor-positive, non-metastatic adenocarcinoma of the breast, who had completed their initial adjuvant treatment pathway (surgery, radiotherapy, or chemotherapy, or a combination) and were receiving', 'Between Dec 18, 2006, and July 22, 2013, 3425 eligible patients were enrolled and randomly assigned; 1711 to the denosumab group and 1709 to the', 'patients with postmenopausal hormone receptor-positive early breast cancer receiving aromatase inhibitor therapy']","['placebo', 'EudraCT', 'subcutaneous denosumab (60 mg) or matching placebo', 'Adjuvant denosumab', 'adjuvant aromatase inhibitors', 'denosumab']","['total number of adverse events', 'local or distant metastasis, contralateral breast cancer, secondary carcinoma, or death from any cause', 'disease-free survival', 'disease-free survival events', 'clinical fractures', 'osteonecrosis of the jaw or confirmed atypical femoral fractures', 'death (due to pneumonia, septic kidney failure, and cardiac decompensation', 'time to first clinical fracture', 'meniscus injury', 'Disease-free survival']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0334277', 'cui_str': 'Adenocarcinoma, metastatic (morphologic abnormality)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C1096616', 'cui_str': 'Contralateral breast cancer'}, {'cui': 'C0085668', 'cui_str': 'Secondary carcinoma'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0029445', 'cui_str': 'Osteonecrosis'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0205182', 'cui_str': 'Atypical (qualifier value)'}, {'cui': 'C0015802', 'cui_str': 'Femoral Fractures'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}, {'cui': 'C0231187', 'cui_str': 'Decompensation (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1096124', 'cui_str': 'Meniscus injury'}]",3425.0,0.686592,"Disease-free survival was significantly improved in the denosumab group versus the placebo group (hazard ratio 0·82, 95% CI 0·69-0·98, Cox p=0·0260; descriptive analysis, without controlling for multiplicity).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gnant', 'Affiliation': 'Department of Surgery, Medical University of Vienna, Vienna, Austria; Comprehensive Cancer Centre, Medical University of Vienna, Vienna, Austria. Electronic address: michael.gnant@meduniwien.ac.at.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Pfeiler', 'Affiliation': 'Comprehensive Cancer Centre, Medical University of Vienna, Vienna, Austria; Department of Gynaecology and Obstetrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Günther G', 'Initials': 'GG', 'LastName': 'Steger', 'Affiliation': 'Department of Internal Medicine I, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Egle', 'Affiliation': 'Department of Gynaecology, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'Department of Internal Medicine III, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Centre for Clinical Cancer and Immunology Trials, Cancer Cluster Salzburg, Salzburg, Austria; Salzburg Cancer Research Institute, Salzburg, Austria.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Fitzal', 'Affiliation': 'Department of Surgery, Medical University of Vienna, Vienna, Austria; Comprehensive Cancer Centre, Medical University of Vienna, Vienna, Austria; Breast Health Centre, Hospital of Sisters of Mercy Linz, Linz, Austria.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Wette', 'Affiliation': 'Breast Centre, Sankt Veit an der Glan, Austria.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Balic', 'Affiliation': 'Department of Oncology, Medical University Graz, Graz, Austria.'}, {'ForeName': 'Ferdinand', 'Initials': 'F', 'LastName': 'Haslbauer', 'Affiliation': 'Department of Internal Medicine, Hospital Voecklabruck, Voecklabruck, Austria.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Melbinger-Zeinitzer', 'Affiliation': 'Department of Surgery, Hospital Wolfsberg, Wolfsberg, Austria.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Bjelic-Radisic', 'Affiliation': 'Department of Gynaecology, Medical University Graz, Graz, Austria.'}, {'ForeName': 'Raimund', 'Initials': 'R', 'LastName': 'Jakesz', 'Affiliation': 'Department of Surgery, Medical University of Vienna, Vienna, Austria; Comprehensive Cancer Centre, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Marth', 'Affiliation': 'Department of Gynaecology, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sevelda', 'Affiliation': 'Department of Gynaecology, Hospital Hietzing, Vienna, Austria.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Mlineritsch', 'Affiliation': 'Department of Internal Medicine III, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Centre for Clinical Cancer and Immunology Trials, Cancer Cluster Salzburg, Salzburg, Austria.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Exner', 'Affiliation': 'Department of Surgery, Medical University of Vienna, Vienna, Austria; Comprehensive Cancer Centre, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Fesl', 'Affiliation': 'Department of Statistics, Austrian Breast & Colorectal Cancer Study Group, Vienna, Austria.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Frantal', 'Affiliation': 'Department of Statistics, Austrian Breast & Colorectal Cancer Study Group, Vienna, Austria.'}, {'ForeName': 'Christian F', 'Initials': 'CF', 'LastName': 'Singer', 'Affiliation': 'Comprehensive Cancer Centre, Medical University of Vienna, Vienna, Austria; Department of Gynaecology and Obstetrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(18)30862-3']
1398,31246522,"Clofarabine Can Replace Anthracyclines and Etoposide in Remission Induction Therapy for Childhood Acute Myeloid Leukemia: The AML08 Multicenter, Randomized Phase III Trial.","PURPOSE


To identify effective and less toxic therapy for children with acute myeloid leukemia, we introduced clofarabine into the first course of remission induction to reduce exposure to daunorubicin and etoposide.
PATIENTS AND METHODS


From 2008 through 2017, 285 patients were enrolled at eight centers; 262 were randomly assigned to receive clofarabine and cytarabine (Clo+AraC, n = 129) or high-dose cytarabine, daunorubicin, and etoposide (HD-ADE, n = 133) as induction I. Induction II consisted of low-dose ADE given alone or combined with sorafenib or vorinostat. Consolidation therapy comprised two or three additional courses of chemotherapy or hematopoietic cell transplantation. Genetic abnormalities and the level of minimal residual disease (MRD) at day 22 of initial remission induction determined final risk classification. The primary end point was MRD at day 22.
RESULTS


Complete remission was induced after two courses of therapy in 263 (92.3%) of the 285 patients; induction failures included four early deaths and 15 cases of resistant leukemia. Day 22 MRD was positive in 57 of 121 randomly assigned evaluable patients (47%) who received Clo+AraC and 42 of 121 patients (35%) who received HD-ADE (odds ratio, 1.86; 95% CI, 1.03 to 3.41;  P  = .04). Despite this result, the 3-year event-free survival rate (52.9% [44.6% to 62.8%] for Clo+AraC  v  52.4% [44.0% to 62.4%] for HD-ADE,  P  = .94) and overall survival rate (74.8% [67.1% to 83.3%] for Clo+AraC  v  64.6% [56.2% to 74.2%] for HD-ADE,  P  = .1) did not differ significantly across the two arms.
CONCLUSION


Our findings suggest that the use of clofarabine with cytarabine during remission induction might reduce the need for anthracycline and etoposide in pediatric patients with acute myeloid leukemia and may reduce rates of cardiomyopathy and treatment-related cancer.",2019,"Despite this result, the 3-year event-free survival rate (52.9% [44.6% to 62.8%] for Clo+AraC  v  52.4% [44.0% to 62.4%] for HD-ADE,  P  = .94) and overall survival rate (74.8% [67.1% to 83.3%] for Clo+AraC  v  64.6% [56.2% to 74.2%] for HD-ADE,  P  = .1) did not differ significantly across the two arms.
","['Childhood Acute Myeloid Leukemia', 'children with acute myeloid leukemia', 'pediatric patients with acute myeloid leukemia', 'From 2008 through 2017', '285 patients were enrolled at eight centers; 262']","['daunorubicin and etoposide', 'chemotherapy or hematopoietic cell transplantation', 'Clofarabine', 'toxic therapy', 'Clo+AraC', 'clofarabine and cytarabine (Clo+AraC, n = 129) or high-dose cytarabine, daunorubicin, and etoposide (HD-ADE, n = 133) as induction I. Induction II consisted of low-dose ADE given alone or combined with sorafenib or vorinostat', 'Anthracyclines and Etoposide', 'clofarabine with cytarabine', 'clofarabine']","['overall survival rate', 'Genetic abnormalities and the level of minimal residual disease (MRD', '3-year event-free survival rate']","[{'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}, {'cui': 'C0092777', 'cui_str': 'clofarabine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0672708', 'cui_str': 'Vorinostat'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0242596', 'cui_str': 'Minimal Disease, Residual'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",285.0,0.106142,"Despite this result, the 3-year event-free survival rate (52.9% [44.6% to 62.8%] for Clo+AraC  v  52.4% [44.0% to 62.4%] for HD-ADE,  P  = .94) and overall survival rate (74.8% [67.1% to 83.3%] for Clo+AraC  v  64.6% [56.2% to 74.2%] for HD-ADE,  P  = .1) did not differ significantly across the two arms.
","[{'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Rubnitz', 'Affiliation': ""1St Jude Children's Research Hospital and the University of Tennessee Health Science Center, College of Medicine, Memphis, TN.""}, {'ForeName': 'Norman J', 'Initials': 'NJ', 'LastName': 'Lacayo', 'Affiliation': ""2Lucile Packard Children's Hospital and Stanford Cancer Center, Palo Alto, CA.""}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Inaba', 'Affiliation': ""1St Jude Children's Research Hospital and the University of Tennessee Health Science Center, College of Medicine, Memphis, TN.""}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Heym', 'Affiliation': ""3Cook Children's Medical Center, Fort Worth, TX.""}, {'ForeName': 'Raul C', 'Initials': 'RC', 'LastName': 'Ribeiro', 'Affiliation': ""1St Jude Children's Research Hospital and the University of Tennessee Health Science Center, College of Medicine, Memphis, TN.""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Taub', 'Affiliation': ""4Children's Hospital of Michigan, Detroit, MI.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'McNeer', 'Affiliation': '5University of Chicago, Chicago, IL.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Degar', 'Affiliation': '6Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Schiff', 'Affiliation': ""7Rady Children's Hospital, San Diego, CA.""}, {'ForeName': 'Allen Eng-Juh', 'Initials': 'AE', 'LastName': 'Yeoh', 'Affiliation': '8National University Health System, Singapore.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Coustan-Smith', 'Affiliation': '8National University Health System, Singapore.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""1St Jude Children's Research Hospital and the University of Tennessee Health Science Center, College of Medicine, Memphis, TN.""}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Triplett', 'Affiliation': ""1St Jude Children's Research Hospital and the University of Tennessee Health Science Center, College of Medicine, Memphis, TN.""}, {'ForeName': 'Susana C', 'Initials': 'SC', 'LastName': 'Raimondi', 'Affiliation': ""1St Jude Children's Research Hospital and the University of Tennessee Health Science Center, College of Medicine, Memphis, TN.""}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Klco', 'Affiliation': ""1St Jude Children's Research Hospital and the University of Tennessee Health Science Center, College of Medicine, Memphis, TN.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': ""1St Jude Children's Research Hospital and the University of Tennessee Health Science Center, College of Medicine, Memphis, TN.""}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Pounds', 'Affiliation': ""1St Jude Children's Research Hospital and the University of Tennessee Health Science Center, College of Medicine, Memphis, TN.""}, {'ForeName': 'Ching-Hon', 'Initials': 'CH', 'LastName': 'Pui', 'Affiliation': ""1St Jude Children's Research Hospital and the University of Tennessee Health Science Center, College of Medicine, Memphis, TN.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00327']
1399,31693429,Polatuzumab Vedotin in Relapsed or Refractory Diffuse Large B-Cell Lymphoma.,"PURPOSE


Patients with transplantation-ineligible relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) fare poorly, with limited treatment options. The antibody-drug conjugate polatuzumab vedotin targets CD79b, a B-cell receptor component.
METHODS


Safety and efficacy of polatuzumab vedotin with bendamustine and obinutuzumab (pola-BG) was evaluated in a single-arm cohort. Polatuzumab vedotin combined with bendamustine and rituximab (pola-BR) was compared with bendamustine and rituximab (BR) in a randomly assigned cohort of patients with transplantation-ineligible R/R DLBCL (primary end point: independent review committee [IRC] assessed complete response [CR] rate at the end of treatment). Duration of response, progression-free survival (PFS), and overall survival (OS) were analyzed using Kaplan-Meier and Cox regression methods.
RESULTS


Pola-BG and pola-BR had a tolerable safety profile. The phase Ib/II pola-BG cohort (n = 27) had a CR rate of 29.6% and a median OS of 10.8 months (median follow-up, 27.0 months). In the randomly assigned cohort (n = 80; 40 per arm), pola-BR patients had a significantly higher IRC-assessed CR rate (40.0%  v  17.5%;  P  = .026) and longer IRC-assessed PFS (median, 9.5  v  3.7 months; hazard ratio [HR], 0.36, 95% CI, 0.21 to 0.63;  P  < .001) and OS (median, 12.4  v  4.7 months; HR, 0.42; 95% CI, 0.24 to 0.75;  P  = .002; median follow-up, 22.3 months). Pola-BR patients had higher rates of grade 3-4 neutropenia (46.2%  v  33.3%), anemia (28.2%  v  17.9%), and thrombocytopenia (41%  v  23.1%), but similar grade 3-4 infections (23.1%  v  20.5%), versus the BR group. Peripheral neuropathy associated with polatuzumab vedotin (43.6% of patients) was grade 1-2 and resolved in most patients.
CONCLUSION


Polatuzumab vedotin combined with BR resulted in a significantly higher CR rate and reduced the risk of death by 58% compared with BR in patients with transplantation-ineligible R/R DLBCL.",2020,"Peripheral neuropathy associated with polatuzumab vedotin (43.6% of patients) was grade 1-2 and resolved in most patients.
","['patients with transplantation-ineligible R/R DLBCL (primary end point', 'Patients with transplantation-ineligible relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL']","['polatuzumab vedotin with bendamustine and obinutuzumab (pola-BG', 'Polatuzumab vedotin combined with bendamustine and rituximab (pola-BR', 'bendamustine and rituximab (BR']","['risk of death', 'complete response [CR] rate', 'rates of grade 3-4 neutropenia', 'longer IRC-assessed PFS', 'anemia', 'CR rate', 'Duration of response, progression-free survival (PFS), and overall survival (OS', 'tolerable safety profile', 'IRC-assessed CR rate', 'thrombocytopenia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0079744', 'cui_str': 'Diffuse Large-Cell Lymphoma'}]","[{'cui': 'C4078806', 'cui_str': 'polatuzumab vedotin'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}]",,0.250087,"Peripheral neuropathy associated with polatuzumab vedotin (43.6% of patients) was grade 1-2 and resolved in most patients.
","[{'ForeName': 'Laurie H', 'Initials': 'LH', 'LastName': 'Sehn', 'Affiliation': 'BC Cancer Centre for Lymphoid Cancer and The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Alex F', 'Initials': 'AF', 'LastName': 'Herrera', 'Affiliation': 'City of Hope, Duarte, CA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Flowers', 'Affiliation': 'Winship Cancer Institute of Emory University, Atlanta, GA.'}, {'ForeName': 'Manali K', 'Initials': 'MK', 'LastName': 'Kamdar', 'Affiliation': 'University of Colorado, Aurora, CO.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McMillan', 'Affiliation': 'Nottingham University Hospitals, Nottingham, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hertzberg', 'Affiliation': 'Prince of Wales Hospital and University of NSW, Sydney, NSW, Australia.'}, {'ForeName': 'Sarit', 'Initials': 'S', 'LastName': 'Assouline', 'Affiliation': 'Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Tae Min', 'Initials': 'TM', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Won Seog', 'Initials': 'WS', 'LastName': 'Kim', 'Affiliation': 'Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'Muhit', 'Initials': 'M', 'LastName': 'Ozcan', 'Affiliation': 'Ankara University, Ankara, Turkey.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Hirata', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Elicia', 'Initials': 'E', 'LastName': 'Penuel', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Joseph N', 'Initials': 'JN', 'LastName': 'Paulson', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'F. Hoffman-La Roche, Mississauga, Ontario, Canada.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Ku', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Matasar', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00172']
1400,31694611,"Study protocol for a parallel-group, double-blinded, randomized, controlled, noninferiority trial: the effect and safety of hybrid electroconvulsive therapy (Hybrid-ECT) compared with routine electroconvulsive therapy in patients with depression.","BACKGROUND


Electroconvulsive therapy (ECT) is the most rapid and effective treatment for patients with depression, ECT can achieve remarkable antidepressant effects in the initial 3-4 sessions, but significant side effects limit its use. However, recent low-charge electrotherapy (LCE) studies have demonstrated antidepressant or antipsychotic effects with significantly fewer side effects. The aim of this study is to propose a novel two-step charge set strategy for ECT treatment, referred to as Hybrid-ECT, to decrease side effects by using a low charge while preserving treatment efficacy.
METHODS/DESIGN


A randomized, double-blinded, standard-controlled, parallel-group design will be carried out. We plan to enroll 112 inpatients diagnosed with depression (unipolar or bipolar) and randomly assign them to conventional ECT (control group) or to Hybrid-ECT (treatment group, 3 ECT sessions followed by LCE sessions (approximately 2.8 joules per session)). We will evaluate participants across a wide variety of domains including clinical symptoms, cognitive, psychological and functional metrics. We will also perform magnetic resonance imaging (MRI) and event-related potential (ERPs) assessments during treatment to explore brain function differences between ECT and LCE.
DISCUSSION


This research proposes a simple but completely novel ECT strategy that aims to rapidly relieve depressive symptoms and minimize side effects. The mechanism of ECT and LCE will be further discussed.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, Number: ChiCTR1900022905 (Registration date: April 30, 2019).",2019,"We plan to enroll 112 inpatients diagnosed with depression (unipolar or bipolar) and randomly assign them to conventional ECT (control group) or to Hybrid-ECT (treatment group, 3 ECT sessions followed by LCE sessions (approximately 2.8 joules per session)).","['Chinese Clinical Trial Registry, Number', 'patients with depression', '112 inpatients diagnosed with depression (unipolar or bipolar']","['routine electroconvulsive therapy', 'conventional ECT (control group) or to Hybrid-ECT (treatment group, 3 ECT sessions followed by LCE sessions', 'Electroconvulsive therapy (ECT', 'hybrid electroconvulsive therapy (Hybrid-ECT']",[],"[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0443340', 'cui_str': 'Unipolar (qualifier value)'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]",[],112.0,0.471667,"We plan to enroll 112 inpatients diagnosed with depression (unipolar or bipolar) and randomly assign them to conventional ECT (control group) or to Hybrid-ECT (treatment group, 3 ECT sessions followed by LCE sessions (approximately 2.8 joules per session)).","[{'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Rong', 'Affiliation': 'Department of Psychiatry, Shenzhen Kangning Hospital, Shenzhen, Guangdong, China.'}, {'ForeName': 'Shu-Xian', 'Initials': 'SX', 'LastName': 'Xu', 'Affiliation': 'Department of Psychiatry, Shenzhen Kangning Hospital, Shenzhen, Guangdong, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zeng', 'Affiliation': 'Department of Psychiatry, Shenzhen Kangning Hospital, Shenzhen, Guangdong, China.'}, {'ForeName': 'Ying-Jia', 'Initials': 'YJ', 'LastName': 'Yang', 'Affiliation': 'Department of Psychiatry, Shenzhen Kangning Hospital, Shenzhen, Guangdong, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Psychiatry, Shenzhen Kangning Hospital, Shenzhen, Guangdong, China.'}, {'ForeName': 'Wen-Tao', 'Initials': 'WT', 'LastName': 'Lai', 'Affiliation': 'Department of Psychiatry, Shenzhen Kangning Hospital, Shenzhen, Guangdong, China.'}, {'ForeName': 'Li-Chang', 'Initials': 'LC', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistics, School of Public Health, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Wen-Feng', 'Initials': 'WF', 'LastName': 'Deng', 'Affiliation': ""Laboratory of Brain Stimulation and Biological Psychiatry, Brain Function and Psychosomatic Medicine Institute, Second People's Hospital of Huizhou, Huizhou, Guangdong, China.""}, {'ForeName': 'Xiangyang', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'CAS Key Laboratory of Mental Health, Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Ying-Li', 'Initials': 'YL', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychiatry, Shenzhen Kangning Hospital, Shenzhen, Guangdong, China.'}, {'ForeName': 'Min-Zhi', 'Initials': 'MZ', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry, Shenzhen Kangning Hospital, Shenzhen, Guangdong, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Key Laboratory of Intelligent Information Processing, Advanced Computer Research Center, Institute of Computing Technology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Xin-Hui', 'Initials': 'XH', 'LastName': 'Xie', 'Affiliation': 'Department of Psychiatry, Shenzhen Kangning Hospital, Shenzhen, Guangdong, China. xxh.med@gmail.com.'}]",BMC psychiatry,['10.1186/s12888-019-2320-3']
1401,30134294,Costs of streamlined HIV care delivery in rural Ugandan and Kenyan clinics in the SEARCH Studys.,"OBJECTIVES/DESIGN


As antiretroviral therapy (ART) rapidly expands in sub-Saharan Africa using new efficient care models, data on costs of these approaches are lacking. We examined costs of a streamlined HIV care delivery model within a large HIV test-and-treat study in Uganda and Kenya.
METHODS


We calculated observed per-person-per-year (ppy) costs of streamlined care in 17 health facilities in SEARCH Study intervention communities (NCT: 01864603) via micro-costing techniques, time-and-motion studies, staff interviews, and administrative records. Cost categories included salaries, ART, viral load testing, recurring goods/services, and fixed capital/facility costs. We then modeled costs under three increasingly efficient scale-up scenarios: lowest-cost ART, centralized viral load testing, and governmental healthcare worker salaries. We assessed the relationship between community-specific ART delivery costs, retention in care, and viral suppression.
RESULTS


Estimated streamlined HIV care delivery costs were $291/ppy. ART ($117/ppy for TDF/3TC/EFV [40%]) and viral load testing ($110/ppy for 2 tests/year [39%]) dominated costs versus salaries ($51/ppy), recurring costs ($5/ppy), and fixed costs ($7/ppy). Optimized ART scale-up with lowest-cost ART ($100/ppy), annual viral load testing ($24/ppy), and governmental healthcare salaries ($27/ppy), lowered streamlined care cost to $163/ppy. We found clinic-to-clinic heterogeneity in retention and viral suppression levels versus streamlined care delivery costs, but no correlation between cost and either retention or viral suppression.
CONCLUSIONS


In the SEARCH Study, streamlined HIV care delivery costs were similar to or lower than prior estimates despite including viral load testing; further optimizations could substantially reduce costs further. These data can inform global strategies for financing ART expansion to achieve UNAIDS 90-90-90 targets.",2018,"We found clinic-to-clinic heterogeneity in retention and viral suppression levels versus streamlined care delivery costs, but no correlation between cost and either retention or viral suppression.
","['rural Ugandan and Kenyan clinics', 'We calculated observed per-person-per-year (ppy) costs of streamlined care in 17 health facilities in SEARCH Study intervention communities (NCT: 01864603) via micro-costing techniques, time-and-motion studies, staff interviews, and administrative records', 'Uganda and Kenya']",[],"['salaries, ART, viral load testing, recurring goods/services, and fixed capital/facility costs', 'Estimated streamlined HIV care delivery costs', 'costs versus salaries ($51/ppy), recurring costs ($5/ppy), and fixed costs']","[{'cui': 'C0241520', 'cui_str': 'Ugandans (ethnic group)'}, {'cui': 'C0337839', 'cui_str': 'Kenyans (ethnic group)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C1704764', 'cui_str': 'Per'}, {'cui': 'C0439508', 'cui_str': 'per year'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018704', 'cui_str': 'Health Facilities'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0040224', 'cui_str': 'Time and Motion Studies'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1301664', 'cui_str': 'Administrative record'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}]",[],"[{'cui': 'C0036064', 'cui_str': 'Wages'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]",90.0,0.0469382,"We found clinic-to-clinic heterogeneity in retention and viral suppression levels versus streamlined care delivery costs, but no correlation between cost and either retention or viral suppression.
","[{'ForeName': 'Starley B', 'Initials': 'SB', 'LastName': 'Shade', 'Affiliation': 'Institute for Global Health Sciences.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Osmand', 'Affiliation': 'Division of Prevention Science, University of California, San Francisco, California, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Luo', 'Affiliation': 'Institute for Global Health Sciences.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Aine', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Elly', 'Initials': 'E', 'LastName': 'Assurah', 'Affiliation': 'Kenya Medical Research Institute.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Mwebaza', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Mwai', 'Affiliation': 'University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Asiphas', 'Initials': 'A', 'LastName': 'Owaraganise', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Mwangwa', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Ayieko', 'Affiliation': 'Kenya Medical Research Institute.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Black', 'Affiliation': 'Division of HIV, Infectious Diseases & Global Medicine, University of California, San Francisco, California.'}, {'ForeName': 'Lillian B', 'Initials': 'LB', 'LastName': 'Brown', 'Affiliation': 'Division of HIV, Infectious Diseases & Global Medicine, University of California, San Francisco, California.'}, {'ForeName': 'Tamara D', 'Initials': 'TD', 'LastName': 'Clark', 'Affiliation': 'Division of HIV, Infectious Diseases & Global Medicine, University of California, San Francisco, California.'}, {'ForeName': 'Dalsone', 'Initials': 'D', 'LastName': 'Kwarisiima', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Harsha', 'Initials': 'H', 'LastName': 'Thirumurthy', 'Affiliation': 'Department of Medical and Health Policy, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Cohen', 'Affiliation': 'Bixby Center for Reproductive Health, University of California, San Francisco, California.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Bukusi', 'Affiliation': 'Kenya Medical Research Institute.'}, {'ForeName': 'Edwin D', 'Initials': 'ED', 'LastName': 'Charlebois', 'Affiliation': 'Division of Prevention Science, University of California, San Francisco, California, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Balzer', 'Affiliation': 'School of Public Health & Health Sciences, University of Massachusetts, Amherst, Massachusetts, USA.'}, {'ForeName': 'Moses R', 'Initials': 'MR', 'LastName': 'Kamya', 'Affiliation': 'School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'Maya L', 'Initials': 'ML', 'LastName': 'Petersen', 'Affiliation': 'Berkeley School of Public Health, Berkeley, California, USA.'}, {'ForeName': 'Diane V', 'Initials': 'DV', 'LastName': 'Havlir', 'Affiliation': 'Division of HIV, Infectious Diseases & Global Medicine, University of California, San Francisco, California.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Jain', 'Affiliation': 'Division of HIV, Infectious Diseases & Global Medicine, University of California, San Francisco, California.'}]","AIDS (London, England)",['10.1097/QAD.0000000000001958']
1402,30747548,Effects of Tai Chi on Cerebral Hemodynamics and Health-Related Outcomes in Older Community Adults at Risk of Ischemic Stroke: A Randomized Controlled Trial.,"This study investigated the effects of Tai Chi compared with no exercise control on the cerebral hemodynamic parameters and other health-related factors in community older adults at risk of ischemic stroke. A total of 170 eligible participants were randomly allocated to Tai Chi or control group. The cerebral hemodynamic parameters and physical fitness risk factors of cardiovascular disease were measured at baseline, 12 weeks, and 24 weeks. After the 12-week intervention, Tai Chi significantly improved the minimum of blood flow velocity (BFV min ); BFV mean ; pulsatility index and resistance index of the right anterior cerebral artery; and BFV max , BFV min , and BFV mean  parameters of the right middle cerebral artery. Tai Chi training also decreased triglyceride, fasting blood glucose, and homocysteine levels, and improved balance ability. Therefore, the supervised 12-week Tai Chi exercise had potential beneficial effects on cerebral hemodynamics, plasma risk factors, and balance ability in older community adults at risk of ischemic stroke.",2019,"Tai Chi training also decreased triglyceride, fasting blood glucose, and homocysteine levels, and improved balance ability.","['older community adults at risk of ischemic stroke', 'A total of 170 eligible participants', 'Older Community Adults at Risk of Ischemic Stroke', 'community older adults at risk of ischemic stroke']","['Tai Chi compared with no exercise control', 'Tai Chi or control group', 'Tai Chi', 'Tai Chi training']","['minimum of blood flow velocity (BFV min ); BFV mean ; pulsatility index and resistance index of the right anterior cerebral artery; and BFV max , BFV min , and BFV mean  parameters of the right middle cerebral artery', 'cerebral hemodynamic parameters', 'cerebral hemodynamic parameters and physical fitness risk factors of cardiovascular disease', 'cerebral hemodynamics, plasma risk factors, and balance ability', 'Cerebral Hemodynamics and Health-Related Outcomes', 'triglyceride, fasting blood glucose, and homocysteine levels, and improved balance ability']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}]","[{'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0005798', 'cui_str': 'Blood Flow Velocity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0226201', 'cui_str': 'Structure of right anterior cerebral artery'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0226213', 'cui_str': 'Structure of right middle cerebral artery'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance (observable entity)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C2242817', 'cui_str': 'Homocysteine measurement (procedure)'}, {'cui': 'C4508995', 'cui_str': 'Improved balance'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",170.0,0.0270797,"Tai Chi training also decreased triglyceride, fasting blood glucose, and homocysteine levels, and improved balance ability.","[{'ForeName': 'Guohua', 'Initials': 'G', 'LastName': 'Zheng', 'Affiliation': ''}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': ''}, {'ForeName': 'Junzhe', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Tingjin', 'Initials': 'T', 'LastName': 'Duan', 'Affiliation': ''}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Ling', 'Affiliation': ''}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Tao', 'Affiliation': ''}, {'ForeName': 'Lidian', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2018-0232']
1403,30747564,The Feasibility of Remotely Delivered Exercise Session in Adults With Alzheimer's Disease and Their Caregivers.,"Adults with Alzheimer's disease (AD) and their caregivers represent a segment of the population with low levels of moderate-intensity physical activity (MPA) and limited options for increasing MPA. The purpose of this study was to evaluate the feasibility of a group video conference approach for increasing MPA in adults with AD and their caregivers. Adults with AD and their caregivers attended 30-min group exercise sessions three times per week for 12 weeks. Exercise sessions and support sessions were delivered in their homes on a tablet computer over video conferencing software. Nine adults with AD/caregiver dyads enrolled, and seven completed the 12-week intervention. Adults with AD attended 77.3% of the group exercise sessions, and caregivers attended 79.2% of group exercise sessions. Weekly MPA increased in both adults with AD (49%) and caregivers (30%). Exercise delivered by group video conferencing is a feasible and potentially effective approach for increasing MPA in adults with AD and their caregivers.",2019,Exercise delivered by group video conferencing is a feasible and potentially effective approach for increasing MPA in adults with AD and their caregivers.,"['Adults with AD and their caregivers', ""Adults with Alzheimer's disease (AD) and their caregivers represent a segment of the population with low levels of moderate-intensity physical activity (MPA) and limited options for increasing MPA"", ""Adults With Alzheimer's Disease and Their Caregivers"", 'Nine adults with AD/caregiver dyads enrolled, and seven completed the 12-week intervention', 'adults with AD and their caregivers']","['Remotely Delivered Exercise Session', 'Exercise delivered by group video conferencing']",['Weekly MPA'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]",9.0,0.0413417,Exercise delivered by group video conferencing is a feasible and potentially effective approach for increasing MPA in adults with AD and their caregivers.,"[{'ForeName': 'Lauren T', 'Initials': 'LT', 'LastName': 'Ptomey', 'Affiliation': ''}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Vidoni', 'Affiliation': ''}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Montenegro-Montenegro', 'Affiliation': ''}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Thompson', 'Affiliation': ''}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Sherman', 'Affiliation': ''}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Gorczyca', 'Affiliation': ''}, {'ForeName': 'Jerry L', 'Initials': 'JL', 'LastName': 'Greene', 'Affiliation': ''}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Washburn', 'Affiliation': ''}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Donnelly', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2018-0298']
1404,30770291,"Stereotactic ablative radiotherapy versus standard radiotherapy in stage 1 non-small-cell lung cancer (TROG 09.02 CHISEL): a phase 3, open-label, randomised controlled trial.","BACKGROUND


Stereotactic ablative body radiotherapy (SABR) is widely used to treat inoperable stage 1 non-small-cell lung cancer (NSCLC), despite the absence of prospective evidence that this type of treatment improves local control or prolongs overall survival compared with standard radiotherapy. We aimed to compare the two treatment techniques.
METHODS


We did this multicentre, phase 3, randomised, controlled trial in 11 hospitals in Australia and three hospitals in New Zealand. Patients were eligible if they were aged 18 years or older, had biopsy-confirmed stage 1 (T1-T2aN0M0) NSCLC diagnosed on the basis of  18 F-fluorodeoxyglucose PET, and were medically inoperable or had refused surgery. Patients had to have an Eastern Cooperative Oncology Group performance status of 0 or 1, and the tumour had to be peripherally located. Patients were randomly assigned after stratification for T stage and operability in a 2:1 ratio to SABR (54 Gy in three 18 Gy fractions, or 48 Gy in four 12 Gy fractions if the tumour was <2 cm from the chest wall) or standard radiotherapy (66 Gy in 33 daily 2 Gy fractions or 50 Gy in 20 daily 2·5 Gy fractions, depending on institutional preference) using minimisation, so no sequence was pre-generated. Clinicians, patients, and data managers had no previous knowledge of the treatment group to which patients would be assigned; however, the treatment assignment was subsequently open label (because of the nature of the interventions). The primary endpoint was time to local treatment failure (assessed according to Response Evaluation Criteria in Solid Tumors version 1.0), with the hypothesis that SABR would result in superior local control compared with standard radiotherapy. All efficacy analyses were based on the intention-to-treat analysis. Safety analyses were done on a per-protocol basis, according to treatment that the patients actually received. The trial is registered with ClinicalTrials.gov (NCT01014130) and the Australia and New Zealand Clinical Trials Registry (ACTRN12610000479000). The trial is closed to new participants.
FINDINGS


Between Dec 31, 2009, and June 22, 2015, 101 eligible patients were enrolled and randomly assigned to receive SABR (n=66) or standard radiotherapy (n=35). Five (7·6%) patients in the SABR group and two (6·5%) in the standard radiotherapy group did not receive treatment, and a further four in each group withdrew before study end. As of data cutoff (July 31, 2017), median follow-up for local treatment failure was 2·1 years (IQR 1·2-3·6) for patients randomly assigned to standard radiotherapy and 2·6 years (IQR 1·6-3·6) for patients assigned to SABR. 20 (20%) of 101 patients had progressed locally: nine (14%) of 66 patients in the SABR group and 11 (31%) of 35 patients in the standard radiotherapy group, and freedom from local treatment failure was improved in the SABR group compared with the standard radiotherapy group (hazard ratio 0·32, 95% CI 0·13-0·77, p=0·0077). Median time to local treatment failure was not reached in either group. In patients treated with SABR, there was one grade 4 adverse event (dyspnoea) and seven grade 3 adverse events (two cough, one hypoxia, one lung infection, one weight loss, one dyspnoea, and one fatigue) related to treatment compared with two grade 3 events (chest pain) in the standard treatment group.
INTERPRETATION


In patients with inoperable peripherally located stage 1 NSCLC, compared with standard radiotherapy, SABR resulted in superior local control of the primary disease without an increase in major toxicity. The findings of this trial suggest that SABR should be the treatment of choice for this patient group.
FUNDING


The Radiation and Optometry Section of the Australian Government Department of Health with the assistance of Cancer Australia, and the Cancer Society of New Zealand and the Cancer Research Trust New Zealand (formerly Genesis Oncology Trust).",2019,"In patients with inoperable peripherally located stage 1 NSCLC, compared with standard radiotherapy, SABR resulted in superior local control of the primary disease without an increase in major toxicity.","['patients with inoperable peripherally located stage 1 NSCLC', 'Between Dec 31, 2009, and June 22, 2015, 101 eligible patients', '11 hospitals in Australia and three hospitals in New Zealand', 'Patients were eligible if they were aged 18 years or older, had biopsy-confirmed stage 1 (T1-T2aN0M0', 'NSCLC diagnosed on the basis of  18 F-fluorodeoxyglucose PET, and were medically inoperable or had refused surgery', 'Patients had to have an Eastern Cooperative Oncology Group performance status of 0 or 1, and the tumour had to be peripherally located']","['standard radiotherapy, SABR', 'standard radiotherapy', 'SABR', 'Stereotactic ablative radiotherapy', 'Stereotactic ablative body radiotherapy (SABR']","['grade 4 adverse event (dyspnoea) and seven grade 3 adverse events (two cough, one hypoxia, one lung infection, one weight loss, one dyspnoea, and one fatigue', 'Median time to local treatment failure', 'time to local treatment failure', 'freedom from local treatment failure', 'major toxicity', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205187', 'cui_str': 'Inoperable (qualifier value)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0302995', 'cui_str': '18F radioisotope'}, {'cui': 'C4553797', 'cui_str': 'Fluorodeoxyglucose'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C1705116', 'cui_str': 'Refused (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic (qualifier value)'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0876973', 'cui_str': 'Pulmonary infection'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0162643'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",101.0,0.257768,"In patients with inoperable peripherally located stage 1 NSCLC, compared with standard radiotherapy, SABR resulted in superior local control of the primary disease without an increase in major toxicity.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ball', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia. Electronic address: david.ball@petermac.org.'}, {'ForeName': 'G Tao', 'Initials': 'GT', 'LastName': 'Mai', 'Affiliation': 'Princess Alexandra Hospital and University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Vinod', 'Affiliation': 'Liverpool Hospital and University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Babington', 'Affiliation': 'Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Ruben', 'Affiliation': 'Alfred Hospital and Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Kron', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Chesson', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Herschtal', 'Affiliation': 'Centre for Biostatistics and Clinical Trials, Melbourne, VIC, Australia.'}, {'ForeName': 'Marijana', 'Initials': 'M', 'LastName': 'Vanevski', 'Affiliation': 'Centre for Biostatistics and Clinical Trials, Melbourne, VIC, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Rezo', 'Affiliation': 'Canberra Hospital, Canberra, ACT, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Elder', 'Affiliation': 'Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Marketa', 'Initials': 'M', 'LastName': 'Skala', 'Affiliation': 'Royal Hobart Hospital, Tasmania, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wirth', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Wheeler', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Adeline', 'Initials': 'A', 'LastName': 'Lim', 'Affiliation': 'Austin Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Shaw', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Penelope', 'Initials': 'P', 'LastName': 'Schofield', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Swinburne University, Melbourne, VIC, Australia.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Irving', 'Affiliation': 'Royal Melbourne Hospital and University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Solomon', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(18)30896-9']
1405,31655422,"Aquatic exercise and Far Infrared (FIR) modulates pain and blood cytokines in fibromyalgia patients: A double-blind, randomized, placebo-controlled pilot study.","Fibromyalgia (FM) has an inflammatory component, as elevated serum levels of inflammatory biomarkers are associated with its diagnosis. Treatments decreased pain, body temperature, improved quality of life and reduced serum levels of IL-6 in both groups; however, these beneficial effects were more pronounced in aquatic exercise (AE) + Far-Infrared (FIR) group. The findings of the present study suggest that the association of AE to FIR increases the benefits of aquatic exercise in patients with FM.",2019,"Treatments decreased pain, body temperature, improved quality of life and reduced serum levels of IL-6 in both groups; however, these beneficial effects were more pronounced in aquatic exercise (AE) + Far-Infrared (FIR) group.","['fibromyalgia patients', 'patients with FM']","['Aquatic exercise and Far Infrared (FIR', 'placebo']","['aquatic exercise (AE)\u202f+\u202fFar-Infrared (FIR', 'pain, body temperature, improved quality of life and reduced serum levels of IL-6']","[{'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0330195', 'cui_str': 'Fir Tree'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0330195', 'cui_str': 'Fir Tree'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",,0.295474,"Treatments decreased pain, body temperature, improved quality of life and reduced serum levels of IL-6 in both groups; however, these beneficial effects were more pronounced in aquatic exercise (AE) + Far-Infrared (FIR) group.","[{'ForeName': 'Daiana Cristina', 'Initials': 'DC', 'LastName': 'Salm', 'Affiliation': 'Experimental Neuroscience Laboratory (LaNEx), University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil; Postgraduate Program in Health Sciences, University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil.'}, {'ForeName': 'Luiz Augusto Oliveira', 'Initials': 'LAO', 'LastName': 'Belmonte', 'Affiliation': 'Experimental Neuroscience Laboratory (LaNEx), University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil; Postgraduate Program in Health Sciences, University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil.'}, {'ForeName': 'Aline Armiliato', 'Initials': 'AA', 'LastName': 'Emer', 'Affiliation': 'Experimental Neuroscience Laboratory (LaNEx), University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil; Postgraduate Program in Health Sciences, University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil.'}, {'ForeName': 'Larissa Dos Santos', 'Initials': 'LDS', 'LastName': 'Leonel', 'Affiliation': 'Experimental Neuroscience Laboratory (LaNEx), University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil.'}, {'ForeName': 'Rômulo Nolasco', 'Initials': 'RN', 'LastName': 'de Brito', 'Affiliation': 'Experimental Neuroscience Laboratory (LaNEx), University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil; Postgraduate Program in Health Sciences, University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil.'}, {'ForeName': 'Cinthia Calheiros', 'Initials': 'CC', 'LastName': 'da Rocha', 'Affiliation': 'Experimental Neuroscience Laboratory (LaNEx), University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil.'}, {'ForeName': 'Thiago César', 'Initials': 'TC', 'LastName': 'Martins', 'Affiliation': 'Experimental Neuroscience Laboratory (LaNEx), University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil.'}, {'ForeName': 'Diogo Cunha', 'Initials': 'DC', 'LastName': 'Dos Reis', 'Affiliation': 'Technological Center and Biomechanics Laboratory, CDS, Federal University of Santa Catarina, Florianópolis 88040-370, Santa Catarina, Brazil.'}, {'ForeName': 'Antônio Renato Pereira', 'Initials': 'ARP', 'LastName': 'Moro', 'Affiliation': 'Technological Center and Biomechanics Laboratory, CDS, Federal University of Santa Catarina, Florianópolis 88040-370, Santa Catarina, Brazil.'}, {'ForeName': 'Leidiane', 'Initials': 'L', 'LastName': 'Mazzardo-Martins', 'Affiliation': 'Experimental Neuroscience Laboratory (LaNEx), University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil; Postgraduate Program in Neuroscience, Center of Biological Sciences, Federal University of Santa Catarina, Florianópolis, Santa Catarina, Brazil.'}, {'ForeName': 'Maicon Roberto', 'Initials': 'MR', 'LastName': 'Kviecinski', 'Affiliation': 'Postgraduate Program in Health Sciences, University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil.'}, {'ForeName': 'Franciane', 'Initials': 'F', 'LastName': 'Bobinski', 'Affiliation': 'Experimental Neuroscience Laboratory (LaNEx), University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil; Postgraduate Program in Health Sciences, University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil.'}, {'ForeName': 'Afonso Shiguemi Inoue', 'Initials': 'ASI', 'LastName': 'Salgado', 'Affiliation': 'Integrative Physical Therapy Residency Program, Philadelphia University Center, Londrina, Paraná, Brazil.'}, {'ForeName': 'Francisco José', 'Initials': 'FJ', 'LastName': 'Cidral-Filho', 'Affiliation': 'Experimental Neuroscience Laboratory (LaNEx), University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil; Postgraduate Program in Health Sciences, University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil.'}, {'ForeName': 'Daniel Fernandes', 'Initials': 'DF', 'LastName': 'Martins', 'Affiliation': 'Experimental Neuroscience Laboratory (LaNEx), University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil; Postgraduate Program in Health Sciences, University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil. Electronic address: daniel.martins4@unisul.br.'}]",Journal of neuroimmunology,['10.1016/j.jneuroim.2019.577077']
1406,30739001,Study protocol and baseline sample characteristics: From clinic to community: Using peer support as a transition model for improving long-term diabetes-related health outcomes.,"BACKGROUND


The objective of this randomized controlled trial is to examine the effects of a 12-month telephone-based peer-led diabetes self-management support (DSMS) intervention on long-term diabetes-related health outcomes.
METHODS


In total, 197 participants with type 2 diabetes were recruited from specialty care settings (diabetes and endocrinology clinics). They were randomly assigned to 1) a 12-month Peer-Led, Empowerment-based Approach to Self-management Efforts in Diabetes (PLEASED) program where they received 12 weekly contacts from their peer supporter (PS) in the first 3 months, followed by 18 biweekly telephone support contacts over the last 9 months, or 2) usual care. The primary clinical and psychosocial outcomes were HbA1c and diabetes distress (DD), respectively. Secondary outcomes were cardiovascular risk factors. Assessments were conducted at baseline, 3 months, and 12 months.
RESULT


Of 197 recruited participants, 49.7% were female. The majority of participants were married/partnered, well-educated, employed, and Caucasian, with a mean HbA1c of 8.09 ± 1.7. Forty-two percent of participants reported little or no distress. There was no significant difference between the two groups.
DISCUSSION


Despite evidence showing that individuals with poor glycemic control benefit the most from peer support interventions, the majority of such interventions have been designed for and implemented in community and primary care-based settings. The present study investigates a 12-month peer support model to help patients initiate and sustain effective self-management behaviors while transitioning from specialty care to a community setting. The study was completed in November 2018. The outcome data analyses are currently underway.
TRIAL REGISTRATION


The study was registered on clinicaltrials.gov (NT02804620).
PROTOCOL VERSION


The protocol version is 3.5.",2019,"They were randomly assigned to 1) a 12-month Peer-Led, Empowerment-based Approach to Self-management Efforts in Diabetes (PLEASED) program where they received 12 weekly contacts from their peer supporter (PS) in the first 3 months, followed by 18 biweekly telephone support contacts over the last 9 months, or 2) usual care.","['participants were married/partnered, well-educated, employed, and Caucasian, with a mean HbA1c of 8.09\u202f±\u202f1.7', '197 participants with type 2 diabetes were recruited from specialty care settings (diabetes and endocrinology clinics', 'Of 197 recruited participants, 49.7% were female']","['telephone-based peer-led diabetes self-management support (DSMS) intervention', 'Peer-Led, Empowerment-based Approach to Self-management Efforts in Diabetes (PLEASED) program where they received 12 weekly contacts from their peer supporter (PS']","['HbA1c and diabetes distress (DD', 'cardiovascular risk factors', 'little or no distress']","[{'cui': 'C0555047', 'cui_str': 'Married (finding)'}, {'cui': 'C0557351', 'cui_str': 'Employed (finding)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4517512', 'cui_str': '1.7 (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C3810855', 'cui_str': 'Endocrinology clinic'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0700321', 'cui_str': 'Small (qualifier value)'}]",197.0,0.0546922,"They were randomly assigned to 1) a 12-month Peer-Led, Empowerment-based Approach to Self-management Efforts in Diabetes (PLEASED) program where they received 12 weekly contacts from their peer supporter (PS) in the first 3 months, followed by 18 biweekly telephone support contacts over the last 9 months, or 2) usual care.","[{'ForeName': 'Tricia S', 'Initials': 'TS', 'LastName': 'Tang', 'Affiliation': 'Department of Medicine, The University of British Columbia, Gordon and Leslie Diamond Center, 2775 Laurel Street, Room 102011, Vancouver, BC V5Z 1M, Canada. Electronic address: tricia.tang@vch.ca.'}, {'ForeName': 'Rowshanak', 'Initials': 'R', 'LastName': 'Afshar', 'Affiliation': 'Division of Endocrinology, Department of Medicine, The University of British Columbia, Canada. Electronic address: rowshanak.afshar@vch.ca.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Elliott', 'Affiliation': 'Division of Endocrinology, Department of Medicine, The University of British Columbia, Canada. Electronic address: telliott@bcdiabetes.ca.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Kong', 'Affiliation': 'Division of Endocrinology, Department of Medicine, The University of British Columbia, Canada. Electronic address: Jason.kong@vch.ca.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Gill', 'Affiliation': 'Division of Endocrinology, Department of Medicine, The University of British Columbia, Canada. Electronic address: sgill@providencehealth.bc.ca.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.02.002']
1407,31689480,The efficacy of Chinese herbal medicines on acute coronary syndrome with renal insufficiency after percutaneous coronary intervention.,"ETHNOPHARMACOLOGICAL RELEVANCE


Fufang Chuanxiong capsule consists of Angelica sinensis radix and Chuanxiong rhizome, which are used in the traditional Chinese medicine for the treatment of coronary artery disease, and Xinyue capsule is composed of panax quinquefolius saponin extracted from leaves and stems of Panax quinquefolium L, which has the functions of anti-myocardial ischemia, improving myocardial energy metabolism and inhibiting apoptosis of cardiomyocytes.
OBJECTIVE


To observe the role of Chinese herbal medicines in the cardiovascular outcome among patients with acute coronary syndrome (ACS) and renal insufficiency after percutaneous coronary intervention (PCI).
METHODS


The subjects came from the 5C trial (chictr.org number: chictr-trc-07000021), post-PCI patients suffered from ACS with mild-to-moderate renal insufficiency (30 mL•min -1 •1.73 m -2  < estimated glomerular filtration rate≤89 mL•min -1 •1.73 m -2 ) included. The study population consisted of 215 subjects in the control group who were treated with western medicine standard therapy, and 211 subjects in the treatment group who were treated with Chinese herbal medicines (Fufang Chuanxiong Capsule and Xinyue Capsule) for 6 months on the basis of western medicine standard therapy. All were followed for 1 year. The primary endpoint included the composite of cardiac death, nonfatal recurrent myocardial infarction, and ischemia-driven revascularization. Secondary endpoint included the composite of stroke, congestive heart failure, and readmission for ACS. The serum creatinine and estimated glomerular filtration rate (eGFR) were evaluated.
RESULTS


After 1 year follow-up of two groups, there were 16 cases of primary endpoint in the control group and 6 cases of primary endpoint in the treatment group [absolute risk reduction (ARR): 0.046, 95%CI: 0.004-0.088; relative risk (RR): 0.38, 95%CI: 0.15-0.96, P = 0.040]. There were 15 cases of secondary endpoint in the control group and 5 cases of secondary endpoint in the treatment (ARR: 0.041, 95%CI: 0.006-0.086; RR: 0.34, 95%CI: 0.13-0.92, P = 0.033). The eGFR in the treatment group was significantly higher than that in the control group (75.19 ± 16.74 mL min -1 ·1.73 m -2  VS 72.03 ± 14.96 mL min -1 ·1.73 m -2 , P < 0.05). The eGFR in the treatment group was significantly higher after the intervention with Chinese herbal medicines than that before intervention (72.27 ± 11.83 mL min -1 ·1.73 m -2  VS 75.19 ± 16.74 mL min -1 ·1.73 m -2 , P < 0.05).
CONCLUSION


Chinese herbal medicines plus western medicine standard therapy improved clinical outcomes in patients with ACS and mild-to-moderate renal insufficiency. Additionally, this study also demonstrated Chinese herbal medicines were useful in deferring decline of renal function.",2020,"The primary endpoint included the composite of cardiac death, nonfatal recurrent myocardial infarction, and ischemia-driven revascularization.","['patients with ACS and mild-to-moderate renal insufficiency', 'subjects came from the 5C trial (chictr.org number: chictr-trc-07000021), post-PCI patients suffered from ACS with mild-to-moderate renal insufficiency (30\u202fmL•min -1 •1.73\u202fm -2 \u202f<\u202festimated glomerular filtration rate≤89\u202fmL•min -1 •1.73\u202fm', 'acute coronary syndrome with renal insufficiency after percutaneous coronary intervention', '215 subjects in the control group who were treated with western medicine standard therapy, and 211 subjects in the treatment group who were treated with', 'patients with acute coronary syndrome (ACS) and renal insufficiency after percutaneous coronary intervention (PCI']","['Chinese herbal medicines plus western medicine standard therapy', 'Chinese herbal medicines (Fufang Chuanxiong Capsule and Xinyue Capsule', 'Chinese herbal medicines']","['serum creatinine and estimated glomerular filtration rate (eGFR', 'renal function', 'clinical outcomes', 'composite of stroke, congestive heart failure, and readmission for ACS', 'absolute risk reduction (ARR', 'eGFR', 'composite of cardiac death, nonfatal recurrent myocardial infarction, and ischemia-driven revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0232809', 'cui_str': 'Glomerular filtration, function (observable entity)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0376667', 'cui_str': 'Herbal'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C1273412', 'cui_str': 'Chinese herbal medicine'}]","[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C3811844'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure (disorder)'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]",215.0,0.0427361,"The primary endpoint included the composite of cardiac death, nonfatal recurrent myocardial infarction, and ischemia-driven revascularization.","[{'ForeName': 'Da-Wu', 'Initials': 'DW', 'LastName': 'Zhang', 'Affiliation': 'Cardiovascular Diseases Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Shao-Li', 'Initials': 'SL', 'LastName': 'Wang', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China.""}, {'ForeName': 'Pei-Li', 'Initials': 'PL', 'LastName': 'Wang', 'Affiliation': 'Cardiovascular Diseases Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Jian-Peng', 'Initials': 'JP', 'LastName': 'Du', 'Affiliation': 'Cardiovascular Diseases Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Zhu-Ye', 'Initials': 'ZY', 'LastName': 'Gao', 'Affiliation': 'Cardiovascular Diseases Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Cheng-Long', 'Initials': 'CL', 'LastName': 'Wang', 'Affiliation': 'Cardiovascular Diseases Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Cardiovascular Diseases Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Da-Zhuo', 'Initials': 'DZ', 'LastName': 'Shi', 'Affiliation': 'Cardiovascular Diseases Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China. Electronic address: shidazhuo@126.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2019.112354']
1408,31513481,Randomized Phase II Trial of Bevacizumab or Temsirolimus in Combination With Chemotherapy for First Relapse Rhabdomyosarcoma: A Report From the Children's Oncology Group.,"PURPOSE


The primary aim of this clinical trial was to prioritize bevacizumab or temsirolimus for additional investigation in rhabdomyosarcoma (RMS) when administered in combination with cytotoxic chemotherapy to patients with RMS in first relapse with unfavorable prognosis.
PATIENTS AND METHODS


Patients were randomly assigned to receive bevacizumab on day 1 or temsirolimus on days 1, 8, and 15 of each 21-day treatment cycle, together with vinorelbine on days 1 and 8, and cyclophosphamide on day 1 for a maximum of 12 cycles. Local tumor control with surgery and/or radiation therapy was permitted after 6 weeks of treatment. The primary end point was event-free survival (EFS). Radiographic response was assessed at 6 weeks. The study had a phase II selection that was design to detect a 15% difference between the two regimens (α = .2; 1-β = 0.8; two sided test).
RESULTS


Eighty-seven of 100 planned patients were enrolled when the trial was closed after the second interim analysis after 46 events occurred in 68 patients with sufficient follow-up. The O'Brien Fleming boundary at this analysis corresponded to a two-sided  P  value of .058 with an observed two-sided  P  value of .003 favoring temsirolimus. The 6-month EFS for the bevacizumab arm was 54.6% (95% CI, 39.8% to 69.3%) and 69.1% (95% CI, 55.1% to 83%) for the temsirolimus arm. Objective response rates were 28% (95% CI, 13.7% to 41.3%) and 47% (95% CI, 31.5% to 63.2%) for the bevacizumab and temsirolimus arms, respectively ( P  = .12) and, 28% of patients on bevacizumab and 11% on temsirolimus had progressive disease at 6 weeks.
CONCLUSION


Patients who received temsirolimus had a superior EFS compared with bevacizumab. Temsirolimus has been selected for additional investigation in newly diagnosed patients with intermediate-risk RMS.",2019,"Objective response rates were 28% (95% CI, 13.7% to 41.3%) and 47% (95% CI, 31.5% to 63.2%) for the bevacizumab and temsirolimus arms, respectively ( P  = .12) and, 28% of patients on bevacizumab and 11% on temsirolimus had progressive disease at 6 weeks.
","['Patients', 'patients with RMS in first relapse with unfavorable prognosis', 'newly diagnosed patients with intermediate-risk RMS', 'First Relapse Rhabdomyosarcoma', 'Eighty-seven of 100 planned patients', 'rhabdomyosarcoma (RMS']","['cyclophosphamide', 'cytotoxic chemotherapy', 'prioritize bevacizumab', 'vinorelbine', 'Bevacizumab or Temsirolimus', 'bevacizumab', 'Local tumor control with surgery and/or radiation therapy']","['Objective response rates', 'Radiographic response', 'event-free survival (EFS', 'progressive disease']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0033325', 'cui_str': 'Prognosis'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0035412', 'cui_str': 'Rhabdomyosarcoma'}, {'cui': 'C4517895', 'cui_str': 'Eighty-seven'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C4521706', 'cui_str': 'Cytotoxic'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C1707080', 'cui_str': 'temsirolimus'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.121834,"Objective response rates were 28% (95% CI, 13.7% to 41.3%) and 47% (95% CI, 31.5% to 63.2%) for the bevacizumab and temsirolimus arms, respectively ( P  = .12) and, 28% of patients on bevacizumab and 11% on temsirolimus had progressive disease at 6 weeks.
","[{'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Mascarenhas', 'Affiliation': ""Children's Hospital Los Angeles and University of Southern California Keck School of Medicine, Los Angeles, CA.""}, {'ForeName': 'Yueh-Yun', 'Initials': 'YY', 'LastName': 'Chi', 'Affiliation': 'University of Florida, Gainesville, FL.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Hingorani', 'Affiliation': ""Phoenix Children's Hospital, Phoenix, AZ.""}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Anderson', 'Affiliation': 'Merck Research Laboratories: Oncology, North Wales, PA.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Lyden', 'Affiliation': 'University of Nebraska College of Medicine, Omaha, NE.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Rodeberg', 'Affiliation': 'East Carolina University, Greenville, NC.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Indelicato', 'Affiliation': 'University of Florida, Jacksonville, FL.'}, {'ForeName': 'Simon C', 'Initials': 'SC', 'LastName': 'Kao', 'Affiliation': 'University of Iowa Carver College of Medicine, Iowa City, IA.'}, {'ForeName': 'Roshni', 'Initials': 'R', 'LastName': 'Dasgupta', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Sheri L', 'Initials': 'SL', 'LastName': 'Spunt', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Meyer', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, OK.'}, {'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Hawkins', 'Affiliation': 'University of Washington, Seattle, WA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00576']
1409,30659611,"STOP 101: A Phase 1, Randomized, Open-Label, Comparative Bioavailability Study of INP104, Dihydroergotamine Mesylate (DHE) Administered Intranasally by a I123 Precision Olfactory Delivery (POD ®  ) Device, in Healthy Adult Subjects.","OBJECTIVE


Investigate the safety and pharmacokinetics (PK) of INP104, intranasal dihydroergotamine mesylate (DHE) administered via a Precision Olfactory Delivery (POD ®  ) device, (Impel NeuroPharma, Seattle, WA) vs intravenous (IV) DHE and DHE nasal spray (Migranal ®  ) in healthy adult subjects.
METHODS


This was a Phase 1, open-label, randomized, single-dose, 3-period, 3-way crossover study. Subjects received a single dose of A) INP104 1.45 mg (a drug-device combination product composed of DHE and the I123 POD device); B) DHE 45 ®  Injection (IV) 1.0 mg; and C) DHE by Migranal ®  Nasal Spray 2.0 mg. Plasma levels of DHE and the major bioactive metabolite, 8'OH-DHE, were measured, and PK parameters were determined for both. Comparative bioavailability (BA) was assessed by calculating the ratio of the geometric means between treatments for C max  and AUC 0-inf  on the ln-transformed data. Safety was assessed from adverse events, vital signs, electrocardiograms, and clinical laboratory values.
RESULTS


Thirty-eight subjects were enrolled, 36 were dosed with at least 1 IP and 27 were included in the evaluation of PK and comparative BA. DHE plasma levels following INP104 1.45 mg administration reached 93% of C max  by 20 minutes and were comparable to IV DHE 1.0 mg by 30 minutes (1219 ng/mL for INP104 vs 1224 ng/mL for IV DHE), which was the T max  for INP104. From 30 minutes onward, DHE levels for INP104 closely matched those of IV DHE to 48 hours, the last time point measured. In comparison, the C max  for Migranal was 299.6 pg/mL (approximately 4-fold less than INP104) and occurred at 47 minutes, 17 minutes later than INP104. Plasma DHE AUC 0-inf  were 6275, 7490, and 2199 h*pg/mL for INP104, IV DHE, and Migranal, respectively. Variability (coefficient of variation [CV%]) for C max  and AUC 0-inf  for INP104 compared to Migranal indicated more consistent delivery with INP104. In the BA comparison using the PK population (subjects who had received all 3 treatments), the ratios of geometric means (percent) for C max  and AUC 0-inf  were 7.9% and 74.2%, respectively, for INP104: IV DHE, and 445% and 308% for INP104: Migranal. Mean plasma concentration profiles for 8'-OH-DHE were proportionately lower and followed a similar profile to the parent compound, regardless of route of administration (IN vs IV) or delivery system (Migranal vs INP104). Treatment emergent AEs (TEAEs), of mostly mild intensity, were reported by 15/31 (48.4%), 21/32 (65.6%), and 14/34 (41.2%) subjects after INP104, IV DHE, and Migranal, respectively. Treatment-related TEAEs occurred in 6/31 (19.4%), 16/32 (50.0%), and 4/34 (11.8%) subjects after INP104, IV DHE, and Migranal, respectively.
CONCLUSION


INP104 met the predefined statistical criteria for comparative bioavailability with IV DHE and Migranal. The shorter time to reach C max  and at 4 times the plasma concentration of DHE in comparison to Migranal combined with a favorable tolerability profile support further investigation of INP104 as an effective, well tolerated, and non-invasive treatment for acute episodic migraine.",2019,"The shorter time to reach C max  and at 4 times the plasma concentration of DHE in comparison to Migranal combined with a favorable tolerability profile support further investigation of INP104 as an effective, well tolerated, and non-invasive treatment for acute episodic migraine.","['healthy adult subjects', 'Thirty-eight subjects were enrolled, 36 were dosed with at least 1 IP and 27 were included in the evaluation of PK and comparative BA', 'STOP 101', 'Healthy Adult Subjects']","['INP104, intranasal dihydroergotamine mesylate (DHE) administered via a Precision Olfactory Delivery (POD ®  ) device, (Impel NeuroPharma, Seattle, WA) vs intravenous (IV) DHE and DHE nasal spray (Migranal ®  ', 'INP104, Dihydroergotamine Mesylate (DHE', 'INP104 1.45\xa0mg (a drug-device combination product composed of DHE and the I123 POD device); B) DHE 45 ®  Injection (IV', 'I123 Precision Olfactory Delivery (POD ®  ) Device', 'Migranal ®']","['Variability (coefficient of variation [CV%]) for C max  and AUC 0-inf  for INP104', 'ratios of geometric means (percent) for C max  and AUC 0-inf', ""Plasma levels of DHE and the major bioactive metabolite, 8'OH-DHE"", 'DHE plasma levels', 'Comparative bioavailability (BA', 'adverse events, vital signs, electrocardiograms, and clinical laboratory values', 'Plasma DHE AUC 0-inf', 'safety and pharmacokinetics (PK', ""Mean plasma concentration profiles for 8'-OH-DHE""]","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0700532', 'cui_str': 'Dihydroergotamine Mesylate'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0439826', 'cui_str': 'Olfactory (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0643690', 'cui_str': 'DHED'}, {'cui': 'C0461725', 'cui_str': 'Nasal Spray'}, {'cui': 'C0086157', 'cui_str': 'Migranal'}, {'cui': 'C4517505', 'cui_str': '1.45'}, {'cui': 'C1445094', 'cui_str': 'Drug-device combination product'}, {'cui': 'C0733797', 'cui_str': 'DHE-45'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0643690', 'cui_str': 'DHED'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518766'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",38.0,0.0344271,"The shorter time to reach C max  and at 4 times the plasma concentration of DHE in comparison to Migranal combined with a favorable tolerability profile support further investigation of INP104 as an effective, well tolerated, and non-invasive treatment for acute episodic migraine.","[{'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Shrewsbury', 'Affiliation': 'Impel NeuroPharma, Seattle, WA, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Jeleva', 'Affiliation': 'Impel NeuroPharma, Seattle, WA, USA.'}, {'ForeName': 'Kelsey H', 'Initials': 'KH', 'LastName': 'Satterly', 'Affiliation': 'Impel NeuroPharma, Seattle, WA, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Lickliter', 'Affiliation': 'Nucleus Network, Melbourne, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hoekman', 'Affiliation': 'Impel NeuroPharma, Seattle, WA, USA.'}]",Headache,['10.1111/head.13476']
1410,31683319,[Influence of Patients' Profession on Therapeutical Outcome of Patients with Primary Extrinsic Shoulder Impingement].,"PURPOSE


Shoulder complaints are an important reason for inability to work. There are few considerations that link the effect of kind of therapy with ability to work in connection with kind of employment. This prospective, comparative clinical follow-up study examines the influence of occupational activity with conservative and operative therapy on the outcome of therapy in terms of function, pain and ability to work.
METHODS


In this study, 97 patients (women: n=22, men: n=75, mean age: 43.1±10.1 years) with a primary extrinsic shoulder impingement syndrome were included. Patients were divided into blue and white collar workers. Further on the subgroups of conservative and operative therapy were considered. Either a sole conservative therapy or an operative therapy with physiotherapeutic follow-up treatment took place. The conservative therapy was carried out as a structured re-coordination of muscles of the shoulder girdle under supervision of a physiotherapist. In the surgical cohorts an arthroscopic subacromial decompression was performed. Follow-up examinations were passed 3, 6 and 12 months after starting the intervention. Function (Constant Score), pain (NRS) and the duration of inability to work were assessed. The statistical analysis was performed using mixed-design ANOVA to calculate main effect and interactions (therapy*kind of employment*time) adjusted with age, sex and body mass index.
RESULTS


There was no statistically significant difference in terms of function and pain between blue and white collar workers. Office workers showed a significantly longer inability to work 3 months after surgical treatment compared with conservative treatment (7.3±0.8 weeks vs. 0.5±7.3 weeks; p<0.001). Further the group of white collars with operative therapy was significantly longer inable to work than the group of blue collar workers after operative therapy 3 months after surgical treatment (3.0±1.1 weeks vs. 7.3±0.8 weeks; p=0.002).
CONCLUSION


On the one hand, working in an office could be seen as a negative predictor for durance of inability to work. On the other hand, surgical treatment itself was a negative predictor for the durance of inability to work. Furthermore, no difference between conservative and surgical therapy could be observed in function and pain one year after starting the treatment.",2020,Office workers showed a significantly longer inability to work 3 months after surgical treatment compared with conservative treatment (7.3±0.8 weeks vs. 0.5±7.3 weeks; p<0.001).,"['97 patients (women: n=22, men: n=75, mean age: 43.1±10.1 years) with a primary extrinsic shoulder impingement syndrome were included', 'Patients with Primary Extrinsic Shoulder Impingement']","['conservative and operative therapy', 'arthroscopic subacromial decompression']","['function and pain', 'function, pain and ability to work', 'Function (Constant Score), pain (NRS) and the duration of inability to work']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0595947', 'cui_str': 'Extrinsic (qualifier value)'}, {'cui': 'C0376685', 'cui_str': 'Rotator Cuff Impingement Syndrome'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}]","[{'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0408159', 'cui_str': 'Anterior decompression of shoulder joint (procedure)'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4049481', 'cui_str': 'Inability to work'}]",97.0,0.0202278,Office workers showed a significantly longer inability to work 3 months after surgical treatment compared with conservative treatment (7.3±0.8 weeks vs. 0.5±7.3 weeks; p<0.001).,"[{'ForeName': 'Hans-Christian', 'Initials': 'HC', 'LastName': 'Köhler', 'Affiliation': 'Orthopädische Klinik und Poliklinik, Universitätsmedizin Rostock.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Hacke', 'Affiliation': 'Klinik für Kinder- und Jugendmedizin I, Universitätsklinikum Schleswig-Holstein, Campus Kiel.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Gutcke', 'Affiliation': 'Klinik für Orthopädie und Unfallchirurgie, Bundeswehrkrankenhaus Westerstede.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Tischer', 'Affiliation': 'Orthopädische Klinik und Poliklinik, Universitätsmedizin Rostock.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Schulze', 'Affiliation': 'Orthopädische Klinik und Poliklinik, Universitätsmedizin Rostock.'}]",Die Rehabilitation,['10.1055/a-0983-0529']
1411,31845316,The effect of intrathecal bupivacaine/morphine on quality of recovery in robot-assisted radical prostatectomy: a randomised controlled trial.,"Robot-assisted radical prostatectomy causes discomfort in the immediate postoperative period. This randomised controlled trial investigated if intrathecal bupivacaine/morphine, in addition to general anaesthesia, could be beneficial for the postoperative quality of recovery. One hundred and fifty-five patients were randomly allocated to an intervention group that received intrathecal 12.5 mg bupivacaine/300 μg morphine (20% dose reduction in patients > 75 years) or a control group receiving a subcutaneous sham injection and an intravenous loading dose of 0.1 mg.kg -1  morphine. Both groups received standardised general anaesthesia and the same postoperative analgesic regimen. The primary outcome was a decrease in the Quality of Recovery-15 (QoR-15) questionnaire score on postoperative day 1. The intervention group (n = 76) had less reduction in QoR-15 on postoperative day 1; median (IQR [range]) 10% (1-8 [-60% to 50%]) vs. 13% (5-24 [-6% to 50%]), p = 0.019, and used less morphine during the admission; 2 mg (1-7 [0-41 mg]) vs. 15 mg (12-20 [8-61 mg]), p < 0.001. Furthermore, they perceived lower pain scores during exertion; numeric rating scale (NRS) 3 (1-6 [0-9]) vs. 5 (3-7 [0-9]), p = 0.001; less bladder spasms (NRS 1 (0-2 [0-10]) vs. 2 (0-5 [0-10]), p = 0.001 and less sedation; NRS 2 (0-3 [0-10]) vs. 3 (2-6 [0-10]), p = 0.005. Moreover, the intervention group used less rescue medication. Pruritus was more severe in the intervention group; NRS 4 (1-7 [0-10]) vs. 0 (0-1 [0-10]), p = 0.000. We conclude that despite a modest increase in the incidence of pruritus, multimodal pain management with intrathecal bupivacaine/morphine remains a viable option for robot-assisted radical prostatectomy.",2020,"Pruritus was more severe in the intervention group; NRS 4 (1-7 [0-10]) vs. 0 (0-1 [0-10]), p = 0.000.","['One hundred and fifty-five patients', 'robot-assisted radical prostatectomy']","['control group receiving a subcutaneous sham injection and an intravenous loading dose of 0.1\xa0mg.kg -1  morphine', 'morphine', 'Robot-assisted radical prostatectomy', 'bupivacaine/morphine', 'standardised general anaesthesia', 'intrathecal 12.5\xa0mg bupivacaine/300\xa0μg morphine', 'intrathecal bupivacaine/morphine']","['Pruritus', 'bladder spasms', 'pain scores during exertion; numeric rating scale (NRS', 'Quality of Recovery-15 (QoR-15) questionnaire score', 'rescue medication', 'quality of recovery']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C3714444', 'cui_str': 'Loading dose'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C4517544', 'cui_str': '12.5 (qualifier value)'}]","[{'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0426390', 'cui_str': 'Spasm of bladder (finding)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0222045'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",155.0,0.246728,"Pruritus was more severe in the intervention group; NRS 4 (1-7 [0-10]) vs. 0 (0-1 [0-10]), p = 0.000.","[{'ForeName': 'M V', 'Initials': 'MV', 'LastName': 'Koning', 'Affiliation': 'Department of Anaesthesiology, Erasmus Medical Centre, University Medical Centre Rotterdam, the Netherlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'de Vlieger', 'Affiliation': 'Department of Anaesthesiology, Erasmus Medical Centre, University Medical Centre Rotterdam, the Netherlands.'}, {'ForeName': 'A J W', 'Initials': 'AJW', 'LastName': 'Teunissen', 'Affiliation': 'Department of Anaesthesiology, Maasstad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gan', 'Affiliation': 'Department of Urology, Maasstad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Ruijgrok', 'Affiliation': 'Department of Hospital Pharmacy, Erasmus Medical Centre, University Medical Centre Rotterdam, the Netherlands.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'de Graaff', 'Affiliation': 'Department of Anaesthesiology, Erasmus Medical Centre, University Medical Centre Rotterdam, the Netherlands.'}, {'ForeName': 'J S H A', 'Initials': 'JSHA', 'LastName': 'Koopman', 'Affiliation': 'Department of Anaesthesiology, Maasstad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Stolker', 'Affiliation': 'Department of Anaesthesiology, Erasmus Medical Centre, University Medical Centre Rotterdam, the Netherlands.'}]",Anaesthesia,['10.1111/anae.14922']
1412,31690281,Multimodal lifestyle intervention using a web-based tool to improve cardiometabolic health in patients with serious mental illness: results of a cluster randomized controlled trial (LION).,"BACKGROUND


Unhealthy lifestyle behaviours contribute to alarming cardiometabolic risk in patients with serious mental illness (SMI). Evidence-based practical lifestyle tools supporting patients and staff in improving patient lifestyle are lacking.
METHODS


This multi-site randomized controlled pragmatic trial determined the effectiveness of a twelve-month multimodal lifestyle approach, including a web-based tool to improve patients' cardiometabolic health, versus care-as-usual. Using the web tool, nurses (trained in motivational interviewing) assisted patients in assessing their lifestyle behaviours, creating a risk profile and constructing lifestyle goals, which were discussed during fortnightly regular care visits. Twenty-seven community-care and sheltered-living teams were randomized into intervention (N = 17) or control (N = 10) groups, including 244 patients (140 intervention/104 control, 49.2% male, 46.1 ± 10.8 years) with increased waist circumference (WC), BMI or fasting glucose. The primary outcomes concerned differences in WC after six and twelve months intervention, while BMI and metabolic syndrome Z-score were secondary outcome measures.
RESULTS


General multilevel linear mixed models adjusted for antipsychotic medication showed that differences in WC change between intervention and control were - 0.15 cm (95%CI: - 2.49; 2.19) after six and - 1.03 cm (95%CI: - 3.42; 1.35) after twelve months intervention; however, the differences were not statistically significant. No intervention effects were found for secondary outcome measures. The intervention increased patients' readiness to change dietary behaviour.
CONCLUSION


A multimodal web-based intervention facilitating nurses to address lifestyle changes in SMI patients did not improve patient cardiometabolic health. Web-tool use was lower than expected and nurses need more lifestyle coaching knowledge and skills. The type of intervention and delivery mode need optimization to realize effective lifestyle care for SMI patients.
TRIAL REGISTRATION


Dutch Trial Registry, www.trialregister.nl , NTR3765, 21 December 2012.",2019,A multimodal web-based intervention facilitating nurses to address lifestyle changes in SMI patients did not improve patient cardiometabolic health.,"[""patients' cardiometabolic health, versus care-as-usual"", 'patients with serious mental illness (SMI', 'patients with serious mental illness', 'SMI patients', 'Twenty-seven community-care and sheltered-living teams were randomized into intervention (N\u2009=\u200917) or control (N\u2009=\u200910) groups, including 244 patients (140 intervention/104 control, 49.2% male, 46.1\u2009±\u200910.8\u2009years) with increased']","['Multimodal lifestyle intervention', 'nurses (trained in motivational interviewing) assisted patients in assessing their lifestyle behaviours, creating a risk profile and constructing lifestyle goals']","['cardiometabolic health', 'WC change', 'BMI and metabolic syndrome Z-score', 'patient cardiometabolic health', 'waist circumference (WC), BMI or fasting glucose']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517660', 'cui_str': 'Two hundred and forty-four'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0018017', 'cui_str': 'Goals'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]",27.0,0.0841069,A multimodal web-based intervention facilitating nurses to address lifestyle changes in SMI patients did not improve patient cardiometabolic health.,"[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Looijmans', 'Affiliation': 'Department of Health Psychology, University Medical Center Groningen, Hanzeplein 1, PO Box 30.001, 9700, RB, Groningen, The Netherlands. A.Looijmans@umcg.nl.'}, {'ForeName': 'Frederike', 'Initials': 'F', 'LastName': 'Jörg', 'Affiliation': 'Rob Giel Research Centre, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bruggeman', 'Affiliation': 'Rob Giel Research Centre, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Schoevers', 'Affiliation': 'Department of Psychiatry, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Corpeleijn', 'Affiliation': 'Department of Epidemiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}]",BMC psychiatry,['10.1186/s12888-019-2310-5']
1413,31107276,Positive End-expiratory Pressure and Postoperative Atelectasis: A Randomized Controlled Trial.,"BACKGROUND


Positive end-expiratory pressure (PEEP) increases lung volume and protects against alveolar collapse during anesthesia. During emergence, safety preoxygenation preparatory to extubation makes the lung susceptible to gas absorption and alveolar collapse, especially in dependent regions being kept open by PEEP. We hypothesized that withdrawing PEEP before starting emergence preoxygenation would limit postoperative atelectasis formation.
METHODS


This was a randomized controlled evaluator-blinded trial in 30 healthy patients undergoing nonabdominal surgery under general anesthesia and mechanical ventilation with PEEP 7 or 9 cm H2O depending on body mass index. A computed tomography scan at the end of surgery assessed baseline atelectasis. The study subjects were thereafter allocated to either maintained PEEP (n = 16) or zero PEEP (n = 14) during emergence preoxygenation. The primary outcome was change in atelectasis area as evaluated by a second computed tomography scan 30 min after extubation. Oxygenation was assessed by arterial blood gases.
RESULTS


Baseline atelectasis was small and increased modestly during awakening, with no statistically significant difference between groups. With PEEP applied during awakening, the increase in atelectasis area was median (range) 1.6 (-1.1 to 12.3) cm and without PEEP 2.3 (-1.6 to 7.8) cm. The difference was 0.7 cm (95% CI, -0.8 to 2.9 cm; P = 0.400). Postoperative atelectasis for all patients was median 5.2 cm (95% CI, 4.3 to 5.7 cm), corresponding to median 2.5% of the total lung area (95% CI, 2.0 to 3.0%). Postoperative oxygenation was unchanged in both groups when compared to oxygenation in the preoperative awake state.
CONCLUSIONS


Withdrawing PEEP before emergence preoxygenation does not reduce atelectasis formation after nonabdominal surgery. Despite using 100% oxygen during awakening, postoperative atelectasis is small and does not affect oxygenation, possibly conditional on an open lung during anesthesia, as achieved by intraoperative PEEP.",2019,"Postoperative atelectasis (assessed by computed tomography) was small with no effect on oxygenation, whether or not PEEP was used during emergence.
","['30 healthy patients undergoing nonabdominal surgery under general anesthesia and mechanical ventilation with PEEP 7 or 9 cm H2O depending on body mass index', 'Thirty patients undergoing nonabdominal surgery under general anesthesia']","['maintained PEEP', 'zero PEEP', 'Positive end-expiratory pressure (PEEP']","['Positive End-expiratory Pressure and Postoperative Atelectasis', 'Postoperative oxygenation', 'atelectasis area', 'change in atelectasis area', 'arterial blood gases', 'atelectasis formation', 'Postoperative atelectasis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0863179', 'cui_str': 'Peeping'}, {'cui': 'C3177469', 'cui_str': '(pipzH2)(cdo)H2O'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0863179', 'cui_str': 'Peeping'}, {'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}, {'cui': 'C3494516', 'cui_str': 'Positive end expiratory pressure (observable entity)'}]","[{'cui': 'C3494516', 'cui_str': 'Positive end expiratory pressure (observable entity)'}, {'cui': 'C0340074', 'cui_str': 'Postoperative atelectasis (disorder)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0004144', 'cui_str': 'Lung Collapse'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0150411', 'cui_str': 'Blood gases, arterial measurement (procedure)'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}]",30.0,0.506241,"Postoperative atelectasis (assessed by computed tomography) was small with no effect on oxygenation, whether or not PEEP was used during emergence.
","[{'ForeName': 'Erland', 'Initials': 'E', 'LastName': 'Östberg', 'Affiliation': 'From the Departments of Anesthesia and Intensive Care (E.Ö., L.E.) Radiology (A.T.) the Center for Clinical Research (M.E.), Västerås Hospital, Västerås, Sweden the Department of Anesthesia and Intensive Care, Köping County Hospital, Köping, Sweden (E.Ö., L.E.) the Department of Surgical Sciences, Anesthesiology and Intensive Care (H.Z.) the Department of Medical Sciences and Clinical Physiology (G.H.), Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Arnar', 'Initials': 'A', 'LastName': 'Thorisson', 'Affiliation': ''}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Enlund', 'Affiliation': ''}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Zetterström', 'Affiliation': ''}, {'ForeName': 'Göran', 'Initials': 'G', 'LastName': 'Hedenstierna', 'Affiliation': ''}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Edmark', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000002764']
1414,30685564,Comparability of blinded remote and site-based assessments of response to adjunctive esketamine or placebo nasal spray in patients with treatment resistant depression.,"Functional unblinding due to treatment emergent adverse events (TEAEs) may occur with any investigational drug and poses a challenge for double-blind, placebo-controlled studies. This pilot study compared site-based Montgomery-Asberg Depression Rating Scale (MADRS) scores to remote, site-independent scores by blinded raters. Audio-digital recordings of site-based MADRS interviews were obtained from a subset of patients during a double-blind, placebo-controlled study of esketamine nasal spray or placebo spray in treatment resistant depression (Clinical Trials Registration: NCT01998958). Fourteen of 67 patients (21%) in the ITT population were randomly selected from 3 clinical trial sites. The site-based MADRS interviews were recorded at the baseline and 2 h post-dose assessments on the first intranasal dosing day. Site-independent raters scored the recordings and were blinded to treatment and all reported TEAEs, including any transient dissociative/perceptual symptoms. None of the 7 placebo-assigned patients achieved a treatment response or remission at the 2-h post-dose assessment. Four of the 7 esketamine-assigned patients (57.1%) achieved a treatment response at 2-h post-dose, and 3 patients (42.9%) achieved remission. Three esketamine-treated patients experienced transient dissociative symptoms. The remote site-independent raters essentially replicated the site-based MADRS scores and yielded a 92.9% predictive value for matching treatment response and remission rates. This small pilot study affirms that blinded remote ratings (without the likelihood of functional unblinding) are comparable to site-based ratings of efficacy of esketamine nasal spray. The audio-digital recording method offers a reasonable strategy for other studies that may also be vulnerable to functional unblinding due to distinctive TEAEs.",2019,None of the 7 placebo-assigned patients achieved a treatment response or remission at the 2-h post-dose assessment.,"['Fourteen of 67 patients (21%) in the ITT population', 'patients with treatment resistant depression']","['esketamine nasal spray or placebo spray', 'adjunctive esketamine or placebo nasal spray', 'placebo', 'esketamine nasal spray']","['remission', 'treatment response or remission', 'transient dissociative symptoms', 'site-based Montgomery-Asberg Depression Rating Scale (MADRS) scores']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}]","[{'cui': 'C2825616'}, {'cui': 'C0461725', 'cui_str': 'Nasal Spray'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521772', 'cui_str': 'Spray'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4706358', 'cui_str': 'MADRS (Montgomery-Asberg Depression Rating Scale) score'}]",,0.387546,None of the 7 placebo-assigned patients achieved a treatment response or remission at the 2-h post-dose assessment.,"[{'ForeName': 'S D', 'Initials': 'SD', 'LastName': 'Targum', 'Affiliation': 'Bracket LLC (Boston MA), USA. Electronic address: sdtargum@yahoo.com.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Daly', 'Affiliation': 'Janssen Medical Affairs (Titusville NJ), USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fedgchin', 'Affiliation': 'Janssen Research & Development LLC (Titusville NJ, Spring House PA, and San Diego CA), USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Cooper', 'Affiliation': 'Janssen Research & Development LLC (Titusville NJ, Spring House PA, and San Diego CA), USA.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Singh', 'Affiliation': 'Janssen Research & Development LLC (Titusville NJ, Spring House PA, and San Diego CA), USA.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2019.01.017']
1415,30693806,"A Randomized, Double-Blind, Sham-Controlled Study Assessing Electroacupuncture for the Management of Postoperative Pain after Percutaneous Nephrolithotomy.","INTRODUCTION


Percutaneous nephrolithotomy (PCNL) is the gold standard procedure for large renal calculi but postoperative (PO) pain remains a concern. Modifications of the PCNL technique and intraoperative and PO strategies have been tested to reduce pain. PO pain control reducing risk of long-term pain medication and narcotic use is of considerable importance. Acupuncture is a common medical procedure shown to alleviate PO pain. Some benefits are that it is nonpharmacologic, easy to administer, and safe. The purpose of this study was to evaluate the effects of electroacupuncture (EA) on PO pain in patients undergoing PCNL.
MATERIALS AND METHODS


This was a randomized, double-blind, sham-controlled study. The study was Institutional Review Board approved and performed under standard ethical guidelines. Fifty-one patients undergoing PCNL by a single surgeon were randomized to one of the three groups: true EA (n = 17), sham EA (SEA, n = 17), and no acupuncture (control, n = 17). The EA and SEA were performed by a single licensed acupuncturist <1 hour before operation. PCNL was performed without the use of intraoperative nerve block(s) or local anesthetic. Pain scores (visual analog scale [VAS]), narcotic use (morphine equivalents), and side effects were recorded at set intervals postoperatively.
RESULTS


Mean VAS scores for flank and abdomen pain were lower at all time periods in the EA compared with the SEA and control groups. Mean cumulative opioid usage was lower in the EA group immediately postoperatively compared with both SEA and control groups. Two patients in the EA group did not require any PO narcotics. No differences between groups were found for PO nausea and vomiting. No adverse effects of EA or SEA were noted.
CONCLUSIONS


EA significantly reduced PO pain and narcotic usage without any adverse effects after PCNL. This promising treatment for managing PO pain warrants further investigation.",2019,"RESULTS


Mean VAS scores for flank and abdomen pain were lower at all time periods in the EA compared with the SEA and control groups.","['Fifty-one patients undergoing PCNL by a single surgeon', 'Postoperative Pain after Percutaneous Nephrolithotomy', 'patients undergoing PCNL']","['PCNL', 'Acupuncture', 'Percutaneous nephrolithotomy (PCNL', 'Electroacupuncture', 'sham EA (SEA, n\u2009=\u200917), and no acupuncture', 'electroacupuncture (EA']","['pain', 'PO nausea and vomiting', 'PO pain', 'Mean VAS scores for flank and abdomen pain', 'PO pain and narcotic usage', 'Mean cumulative opioid usage', 'Pain scores (visual analog scale [VAS]), narcotic use (morphine equivalents), and side effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0036493', 'cui_str': 'Sea (environment)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0230171', 'cui_str': 'Structure of lateral region of abdomen'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",51.0,0.238906,"RESULTS


Mean VAS scores for flank and abdomen pain were lower at all time periods in the EA compared with the SEA and control groups.","[{'ForeName': 'Jillian L', 'Initials': 'JL', 'LastName': 'Capodice', 'Affiliation': '1 Department of Urology, Icahn School of Medicine at Mount Sinai, Mount Sinai Health System, New York, New York.'}, {'ForeName': 'Egor', 'Initials': 'E', 'LastName': 'Parkhomenko', 'Affiliation': '1 Department of Urology, Icahn School of Medicine at Mount Sinai, Mount Sinai Health System, New York, New York.'}, {'ForeName': 'Timothy Y', 'Initials': 'TY', 'LastName': 'Tran', 'Affiliation': '1 Department of Urology, Icahn School of Medicine at Mount Sinai, Mount Sinai Health System, New York, New York.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Thai', 'Affiliation': '1 Department of Urology, Icahn School of Medicine at Mount Sinai, Mount Sinai Health System, New York, New York.'}, {'ForeName': 'Kyle A', 'Initials': 'KA', 'LastName': 'Blum', 'Affiliation': '1 Department of Urology, Icahn School of Medicine at Mount Sinai, Mount Sinai Health System, New York, New York.'}, {'ForeName': 'Ryan A', 'Initials': 'RA', 'LastName': 'Chandhoke', 'Affiliation': '1 Department of Urology, Icahn School of Medicine at Mount Sinai, Mount Sinai Health System, New York, New York.'}, {'ForeName': 'Mantu', 'Initials': 'M', 'LastName': 'Gupta', 'Affiliation': '1 Department of Urology, Icahn School of Medicine at Mount Sinai, Mount Sinai Health System, New York, New York.'}]",Journal of endourology,['10.1089/end.2018.0665']
1416,30711522,"Hypofractionated versus conventional fractionated postmastectomy radiotherapy for patients with high-risk breast cancer: a randomised, non-inferiority, open-label, phase 3 trial.","BACKGROUND


To our knowledge, no randomised study has compared postmastectomy hypofractionated radiotherapy with conventional fractionated radiotherapy in patients with breast cancer. This study aimed to determine whether a 3-week schedule of postmastectomy hypofractionated radiotherapy is as efficacious and safe as a 5-week schedule of conventional fractionated radiotherapy.
METHODS


This randomised, non-inferiority, open-label, phase 3 study was done in a single academic hospital in China. Patients aged 18-75 years who had undergone mastectomy and had at least four positive axillary lymph nodes or primary tumour stage T3-4 disease were eligible to participate. Patients were randomly assigned (1:1) according to a computer-generated central randomisation schedule, without stratification, to receive chest wall and nodal irradiation at a dose of 50 Gy in 25 fractions over 5 weeks (conventional fractionated radiotherapy) or 43·5 Gy in 15 fractions over 3 weeks (hypofractionated radiotherapy). The modified intention-to-treat population (including all eligible patients who underwent randomisation but excluding those who were considered ineligible or withdrew consent after randomisation) was used in primary and safety analyses. The primary endpoint was 5-year locoregional recurrence, and a 5% margin was used to establish non-inferiority (equivalent to a hazard ratio <1·883). This trial is registered at ClinicalTrials.gov, number NCT00793962.
FINDINGS


Between June 12, 2008, and June 16, 2016, 820 patients were enrolled and randomly assigned to the conventional fractionated radiotherapy group (n=414) or hypofractionated radiotherapy group (n=406). 409 participants in the conventional fractionated radiotherapy group and 401 participants in the hypofractionated radiotherapy group were included in the modified intention-to-treat analyses. At a median follow-up of 58·5 months (IQR 39·2-81·8), 60 (7%) patients had developed locoregional recurrence (31 patients in the hypofractionated radiotherapy group and 29 in the conventional fractionated radiotherapy group); the 5-year cumulative incidence of locoregional recurrence was 8·3% (90% CI 5·8-10·7) in the hypofractionated radiotherapy group and 8·1% (90% CI 5·4-10·6) in the conventional fractionated radiotherapy group (absolute difference 0·2%, 90% CI -3·0 to 2·6; hazard ratio 1·10, 90% CI 0·72 to 1·69; p<0·0001 for non-inferiority). There were no significant differences between the groups in acute and late toxicities, except that fewer patients in the hypofractionated radiotherapy group had grade 3 acute skin toxicity than in the conventional fractionated radiotherapy group (14 [3%] of 401 patients vs 32 [8%] of 409 patients; p<0·0001).
INTERPRETATION


Postmastectomy hypofractionated radiotherapy was non-inferior to and had similar toxicities to conventional fractionated radiotherapy in patients with high-risk breast cancer. Hypofractionated radiotherapy could provide more convenient treatment and allow providers to treat more patients.
FUNDING


National Key Projects of Research and Development of China; the Chinese Academy of Medical Science Innovation Fund for Medical Sciences; and Beijing Marathon of Hope, Cancer Foundation of China.",2019,"INTERPRETATION


Postmastectomy hypofractionated radiotherapy was non-inferior to and had similar toxicities to conventional fractionated radiotherapy in patients with high-risk breast cancer.","['409 participants in the conventional fractionated radiotherapy group and 401 participants in the', 'Patients aged 18-75 years who had undergone mastectomy and had at least four positive axillary lymph nodes or primary tumour stage T3-4 disease were eligible to participate', 'patients with high-risk breast cancer', 'Between June 12, 2008, and June 16, 2016, 820 patients', 'single academic hospital in China', '0·72 to 1·69', 'patients with breast cancer']","['postmastectomy hypofractionated radiotherapy', 'conventional fractionated radiotherapy', 'postmastectomy hypofractionated radiotherapy with conventional fractionated radiotherapy', 'hypofractionated radiotherapy', 'computer-generated central randomisation schedule, without stratification, to receive chest wall and nodal irradiation at a dose of 50 Gy in 25 fractions over 5 weeks (conventional fractionated radiotherapy) or 43·5 Gy in 15 fractions over 3 weeks (hypofractionated radiotherapy', 'Hypofractionated radiotherapy', 'Hypofractionated versus conventional fractionated postmastectomy radiotherapy', 'Postmastectomy hypofractionated radiotherapy']","['5-year locoregional recurrence', 'acute and late toxicities', 'locoregional recurrence', '5-year cumulative incidence of locoregional recurrence', 'grade 3 acute skin toxicity']","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0024886', 'cui_str': 'Total Mastectomy'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0729594', 'cui_str': 'Axillary lymph node structure (body structure)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0475374', 'cui_str': 'Tumor stage T3'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0205076', 'cui_str': 'Chest Wall'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}]",820.0,0.183781,"INTERPRETATION


Postmastectomy hypofractionated radiotherapy was non-inferior to and had similar toxicities to conventional fractionated radiotherapy in patients with high-risk breast cancer.","[{'ForeName': 'Shu-Lian', 'Initials': 'SL', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Fang', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yong-Wen', 'Initials': 'YW', 'LastName': 'Song', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Wei-Hu', 'Initials': 'WH', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Division of Biostatistics and Bioinformatics, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Yue-Ping', 'Initials': 'YP', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xin-Fan', 'Initials': 'XF', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Zi-Hao', 'Initials': 'ZH', 'LastName': 'Yu', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Ren', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ning-Ning', 'Initials': 'NN', 'LastName': 'Lu', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shu-Nan', 'Initials': 'SN', 'LastName': 'Qi', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Guang-Yi', 'Initials': 'GY', 'LastName': 'Sun', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Peng', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ye-Xiong', 'Initials': 'YX', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: yexiong12@163.com.'}]",The Lancet. Oncology,['10.1016/S1470-2045(18)30813-1']
1417,31682542,Gefitinib Alone Versus Gefitinib Plus Chemotherapy for Non-Small-Cell Lung Cancer With Mutated Epidermal Growth Factor Receptor: NEJ009 Study.,"PURPOSE


Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor combined with cytotoxic chemotherapy is highly effective for the treatment of advanced non-small-cell lung cancer (NSCLC) with EGFR mutations; however, little is known about the efficacy and safety of this combination compared with that of standard therapy with EGFR- tyrosine kinase inhibitors alone.
METHODS


We randomly assigned 345 patients with newly diagnosed metastatic NSCLC with EGFR mutations to gefitinib combined with carboplatin plus pemetrexed or gefitinib alone. Progression-free survival (PFS), PFS2, and overall survival (OS) were sequentially analyzed as primary end points according to a hierarchical sequential testing method. Secondary end points were objective response rate (ORR), safety, and quality of life.
RESULTS


The combination group demonstrated a better ORR and PFS than the gefitinib group (ORR, 84%  v  67% [ P  < .001]; PFS, 20.9  v  11.9 months; hazard ratio for death or disease progression, 0.490 [ P  < .001]), although PFS2 was not significantly different (20.9  v  18.0 months;  P  = .092). Median OS in the combination group was also significantly longer than in the gefitinib group (50.9  v  38.8 months; hazard ratio for death, 0.722;  P  = .021). The rate of grade ≥ 3 treatment-related adverse events, such as hematologic toxicities, in the combination group was higher than in the gefitinib group (65.3%  v  31.0%); there were no differences in quality of life. One treatment-related death was observed in the combination group.
CONCLUSION


Compared with gefitinib alone, gefitinib combined with carboplatin plus pemetrexed improved PFS in patients with untreated advanced NSCLC with EGFR mutations with an acceptable toxicity profile, although its OS benefit requires further validation.",2020,"The rate of grade ≥ 3 treatment-related adverse events, such as hematologic toxicities, in the combination group was higher than in the gefitinib group (65.3%  v  31.0%); there were no differences in quality of life.","['345 patients with newly diagnosed metastatic NSCLC with EGFR mutations to gefitinib combined with', 'patients with untreated advanced NSCLC with EGFR mutations', 'advanced non-small-cell lung cancer (NSCLC) with EGFR mutations', 'Non-Small-Cell Lung Cancer']","['carboplatin plus pemetrexed or gefitinib alone', 'gefitinib alone, gefitinib combined with carboplatin plus pemetrexed', 'Gefitinib Alone Versus Gefitinib Plus Chemotherapy', 'cytotoxic chemotherapy']","['rate of grade ≥ 3 treatment-related adverse events, such as hematologic toxicities', 'Progression-free survival (PFS), PFS2, and overall survival (OS', 'PFS', 'death', 'quality of life', 'objective response rate (ORR), safety, and quality of life', 'ORR and PFS', 'PFS2', 'hazard ratio for death or disease progression', 'Median OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer (disorder)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4521706', 'cui_str': 'Cytotoxic'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0034380'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",345.0,0.0966276,"The rate of grade ≥ 3 treatment-related adverse events, such as hematologic toxicities, in the combination group was higher than in the gefitinib group (65.3%  v  31.0%); there were no differences in quality of life.","[{'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Hosomi', 'Affiliation': 'Tokyo Metropolitan Komagome Hospital, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Sugawara', 'Affiliation': 'Sendai Kousei Hospital, Sendai, Japan.'}, {'ForeName': 'Terufumi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Kanagawa Cardiovascular and Respiratory Center, Yokohama, Japan.'}, {'ForeName': 'Tatsuro', 'Initials': 'T', 'LastName': 'Fukuhara', 'Affiliation': 'Miyagi Cancer Center, Natori, Japan.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Gemma', 'Affiliation': 'Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Fujita', 'Affiliation': 'Asahikawa Medical Center, Asahikawa, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Harada', 'Affiliation': 'Japan Community Health Care Organization Hokkaido Hospital, Sapporo, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Minato', 'Affiliation': 'Gunma Prefectural Cancer Center, Ota, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Takamura', 'Affiliation': 'Obihiro Kosei General Hospital, Obihiro, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Hagiwara', 'Affiliation': 'Jichi Medical University, Shimotsuke, Japan.'}, {'ForeName': 'Kunihiko', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Saitama Medical University, Hidaka, Japan.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Nukiwa', 'Affiliation': 'Tohoku University, Sendai, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Inoue', 'Affiliation': 'Tohoku University School of Medicine, Sendai, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01488']
1418,30694609,Flora colonization and oral care in high-risk newborns.,"PURPOSE


A randomized intervention study was conducted to explore the impact of oral care with sterile normal saline to oral flora colonization of high-risk newborns at the third day after birth.
DESIGN AND METHODS


Ninety-two newborns were allocated to either intervention or control group. After obtaining oral secretion for prepoint data, the intervention group received oral care with sterile normal saline only. Oral secretions for postpoint data were obtained 8 hr after the prepoint. Total 179 specimens were obtained during the study period.
RESULTS


Among the total 92 newborns, 44.6% were female and 57.6% were premature. Mean gestational age and weight was 35.9 ± 3.2 weeks and 2,545 ± 697.5 g. The most common colonized flora included Streptococcus (26.3%), methicillin-resistant Staphylococcus aureus (MRSA, 16.2%), and coagulase-negative Staphylococci (CNS, 13.4%). The oral care with normal saline did not change the number of flora type of newborns. The statistic results were not significant by group (F = 0.918, p = 0.514), time (F = 0.322, p = 0.672), and the interaction between time and group (F = 0.519, p = 0.472).
PRACTICE IMPLICATIONS


Oral care with sterile saline did not change oral flora colonization among high-risk newborns at early period of life. This intervention can be safely delivered to high-risk newborns when they are at risk of infection and particularly breast milk is not available.",2019,"The statistic results were not significant by group (F = 0.918, p = 0.514), time (F = 0.322, p = 0.672), and the interaction between time and group (F = 0.519, p = 0.472).
","['Ninety-two newborns', 'high-risk newborns at the third day after birth', 'total 92 newborns, 44.6% were female and 57.6% were premature', 'Mean gestational age and weight was 35.9\u2009±\u20093.2 weeks and 2,545\u2009±\u2009697.5 g. The most common colonized flora included Streptococcus (26.3%), methicillin-resistant Staphylococcus aureus (MRSA, 16.2%), and coagulase-negative Staphylococci (CNS, 13.4', 'high-risk newborns at early period of life', 'Total 179 specimens were obtained during the study period', 'high-risk newborns']","['oral care with sterile normal saline only', 'Oral care with sterile saline', 'normal saline', 'oral care with sterile normal saline']","['number of flora type of newborns', 'change oral flora colonization']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205252', 'cui_str': 'Immature (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C4517668', 'cui_str': 'Twenty-six point three'}, {'cui': 'C1265292', 'cui_str': 'MRSA'}, {'cui': 'C4319690', 'cui_str': '16.2'}, {'cui': 'C0009118', 'cui_str': 'Coagulase'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C4517558', 'cui_str': 'Thirteen point four'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0559895', 'cui_str': 'Periods of life (qualifier value)'}, {'cui': 'C4517609', 'cui_str': '179 (qualifier value)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0232920', 'cui_str': 'Sterile (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]",92.0,0.0540675,"The statistic results were not significant by group (F = 0.918, p = 0.514), time (F = 0.322, p = 0.672), and the interaction between time and group (F = 0.519, p = 0.472).
","[{'ForeName': 'Youngmee', 'Initials': 'Y', 'LastName': 'Ahn', 'Affiliation': 'Department of Nursing, Inha University, Incheon, South Korea.'}, {'ForeName': 'Yonghoon', 'Initials': 'Y', 'LastName': 'Jun', 'Affiliation': 'Department of Pediatrics, College of Medicine, Inha University & Inha University Hospital, Incheon, South Korea.'}, {'ForeName': 'Namhee', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, Hanseo University, Seosan, South Korea.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Sohn', 'Affiliation': 'Department of Nursing, Inha University, Incheon, South Korea.'}]",Journal for specialists in pediatric nursing : JSPN,['10.1111/jspn.12233']
1419,31690105,Comparison of structural and functional outcome of aflibercept versus ranibizumab in patients with myopic choroidal neovascularization.,"PURPOSE


To compare visual functional improvement and retinal structural changes of aflibercept versus ranibizumab for the management of treatment-naïve choroidal neovascularization related to pathological myopia.
PATIENTS AND METHODS


A prospective randomized study included patients suffering from myopic choroidal neovascularization. Patients received three intravitreal injections of aflibercept (2 mg) or ranibizumab (0.5 mg) in 1:1 ratio every 4 weeks. Ophthalmic evaluation and optical coherence tomography were performed at baseline, 1, 2, and 3 months after last injection. Primary outcome measure was the visual acuity change from baseline to month 3 after injection. Secondary outcome measures included change in retinal thickness and the relation of morphological and functional changes to baseline assessment parameters.
RESULTS


A total of 48 myopic patients (48 eyes) suffering from myopic choroidal neovascularization were randomly assigned to receive either aflibercept (Group A) or ranibizumab (Group B). In Group A, best-corrected visual acuity significantly improved from 0.53 ± 0.10 logMAR to 0.38 ± 0.11 logMAR, at 3 months, and from 0.55 ± 0.11 logMAR to 0.39 ± 0.12 logMAR in Group B. Whereas, retinal thickness reduced from 317.7 ± 53.6 µm to 164.5 ± 81.9 µm in Group A, and from 321.1 ± 98.8 µm at baseline to 178.9 ± 64.5 µm in Group B at month 3. Changes in best-corrected visual acuity and central macular thickness were statistically insignificant between the two groups at final visit.
CONCLUSION


Both aflibercept and ranibizumab provided a significant improvement in visual acuity and retinal thickness in patients with myopic choroidal neovascularization. Comparable functional and architectural results were achieved by both treatment modalities.",2019,Both aflibercept and ranibizumab provided a significant improvement in visual acuity and retinal thickness in patients with myopic choroidal neovascularization.,"['patients suffering from myopic choroidal neovascularization', 'patients with myopic choroidal neovascularization', '48 myopic patients (48 eyes) suffering from myopic choroidal neovascularization']","['ranibizumab', 'aflibercept versus ranibizumab', 'aflibercept and ranibizumab', 'aflibercept']","['change in retinal thickness and the relation of morphological and functional changes to baseline assessment parameters', 'visual acuity and central macular thickness', 'best-corrected visual acuity', 'retinal thickness', 'visual acuity and retinal thickness', 'visual acuity change']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3665926', 'cui_str': 'Myopic choroidal neovascularization'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}]",,0.23462,Both aflibercept and ranibizumab provided a significant improvement in visual acuity and retinal thickness in patients with myopic choroidal neovascularization.,"[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Howaidy', 'Affiliation': 'Department of Ophthalmology, Aswan University, Aswan, Egypt.'}, {'ForeName': 'Zeiad H', 'Initials': 'ZH', 'LastName': 'Eldaly', 'Affiliation': 'Department of Ophthalmology, Assiut University Hospital, Assiut, Egypt.'}]",European journal of ophthalmology,['10.1177/1120672119883590']
1420,30718072,"Ramucirumab with cisplatin and fluoropyrimidine as first-line therapy in patients with metastatic gastric or junctional adenocarcinoma (RAINFALL): a double-blind, randomised, placebo-controlled, phase 3 trial.","BACKGROUND


VEGF and VEGF receptor 2 (VEGFR-2)-mediated signalling and angiogenesis can contribute to the pathogenesis and progression of gastric cancer. We aimed to assess whether the addition of ramucirumab, a VEGFR-2 antagonist monoclonal antibody, to first-line chemotherapy improves outcomes in patients with metastatic gastric or gastro-oesophageal junction adenocarcinoma.
METHODS


For this double-blind, randomised, placebo-controlled, phase 3 trial done at 126 centres in 20 countries, we recruited patients aged 18 years or older with metastatic, HER2-negative gastric or gastro-oesophageal junction adenocarcinoma, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and adequate organ function. Eligible patients were randomly assigned (1:1) with an interactive web response system to receive cisplatin (80 mg/m 2 , on the first day) plus capecitabine (1000 mg/m 2 , twice daily for 14 days), every 21 days, and either ramucirumab (8 mg/kg) or placebo on days 1 and 8, every 21 days. 5-Fluorouracil (800 mg/m 2  intravenous infusion on days 1-5) was permitted in patients unable to take capecitabine. The primary endpoint was investigator-assessed progression-free survival, analysed by intention to treat in the first 508 patients. We did a sensitivity analysis of the primary endpoint, including a central review of CT scans. Overall survival was a key secondary endpoint. This study is registered with ClinicalTrials.gov, number NCT02314117.
FINDINGS


Between Jan 28, 2015, and Sept 16, 2016, 645 patients were randomly assigned to receive ramucirumab plus fluoropyrimidine and cisplatin (n=326) or placebo plus fluoropyrimidine and cisplatin (n=319). Investigator-assessed progression-free survival was significantly longer in the ramucirumab group than the placebo group (hazard ratio [HR] 0·753, 95% CI 0·607-0·935, p=0·0106; median progression-free survival 5·7 months [5·5-6·5] vs 5·4 months [4·5-5·7]). A sensitivity analysis based on central independent review of the radiological images did not corroborate the investigator-assessed difference in progression-free survival (HR 0·961, 95% CI 0·768-1·203, p=0·74). There was no difference in overall survival between groups (0·962, 0·801-1·156, p=0·6757; median overall survival 11·2 months [9·9-11·9] in the ramucirumab group vs 10·7 months [9·5-11·9] in the placebo group). The most common grade 3-4 adverse events were neutropenia (85 [26%] of 323 patients in the ramucirumab group vs 85 [27%] of 315 in the placebo group), anaemia (39 [12%] vs 44 [14%]), and hypertension (32 [10%] vs 5 [2%]). The incidence of any-grade serious adverse events was 160 (50%) of 323 patients in the ramucirumab group and 149 (47%) of 315 patients in the placebo group. The most common serious adverse events were vomiting (14 [4%] in the ramucirumab group vs 21 [7%] in the placebo group) and diarrhoea (11 [3%] vs 19 [6%]). There were seven deaths in each group, either during study treatment or within 30 days of discontinuing study treatment, which were the result of treatment-related adverse events. In the ramucirumab group, these adverse events were acute kidney injury, cardiac arrest, gastric haemorrhage, peritonitis, pneumothorax, septic shock, and sudden death (n=1 of each). In the placebo group, these adverse events were cerebrovascular accident (n=1), multiple organ dysfunction syndrome (n=2), pulmonary embolism (n=2), sepsis (n=1), and small intestine perforation (n=1).
INTERPRETATION


Although the primary analysis for progression-free survival was statistically significant, this outcome was not confirmed in a sensitivity analysis of progression-free survival by central independent review, and did not improve overall survival. Therefore, the addition of ramucirumab to cisplatin plus fluoropyrimidine chemotherapy is not recommended as first-line treatment for this patient population.
FUNDING


Eli Lilly and Company.",2019,"There was no difference in overall survival between groups (0·962, 0·801-1·156, p=0·6757; median overall survival 11·2 months [9·9-11·9] in the ramucirumab group vs 10·7 months [9·5-11·9] in the placebo group).","['Between Jan 28, 2015, and Sept 16, 2016', 'patients with metastatic gastric or junctional adenocarcinoma (RAINFALL', '645 patients', 'Eligible patients', 'patients with metastatic gastric or gastro-oesophageal junction adenocarcinoma', '126 centres in 20 countries, we recruited patients aged 18 years or older with metastatic, HER2-negative gastric or gastro-oesophageal junction adenocarcinoma, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and adequate organ function']","['ramucirumab plus fluoropyrimidine and cisplatin (n=326) or placebo plus fluoropyrimidine and cisplatin', 'cisplatin plus fluoropyrimidine chemotherapy', 'placebo', 'interactive web response system to receive cisplatin', 'ramucirumab', 'capecitabine', 'ramucirumab, a VEGFR-2 antagonist monoclonal antibody, to first-line chemotherapy', 'Ramucirumab with cisplatin and fluoropyrimidine', '5-Fluorouracil']","['incidence of any-grade serious adverse events', 'anaemia', 'vomiting', 'Investigator-assessed progression-free survival', 'progression-free survival', 'hypertension', 'Overall survival', 'diarrhoea', 'neutropenia', 'adverse events were cerebrovascular accident (n=1), multiple organ dysfunction syndrome (n=2), pulmonary embolism (n=2), sepsis (n=1), and small intestine perforation (n=1', 'adverse events were acute kidney injury, cardiac arrest, gastric haemorrhage, peritonitis, pneumothorax, septic shock, and sudden death (n=1 of each', 'investigator-assessed progression-free survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0205144', 'cui_str': 'Junctional (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0014871', 'cui_str': 'Gastroesophageal Junction'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0031843', 'cui_str': 'function'}]","[{'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0378796', 'cui_str': 'Flk-1 Protein'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0026766', 'cui_str': 'Organ Dysfunction Syndrome, Multiple'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0151739', 'cui_str': 'Perforation of small intestine (disorder)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0235325', 'cui_str': 'Gastric hemorrhage (disorder)'}, {'cui': 'C0031154', 'cui_str': 'Peritonitis'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C0011071', 'cui_str': 'Sudden death (event)'}]",645.0,0.773776,"There was no difference in overall survival between groups (0·962, 0·801-1·156, p=0·6757; median overall survival 11·2 months [9·9-11·9] in the ramucirumab group vs 10·7 months [9·5-11·9] in the placebo group).","[{'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Fuchs', 'Affiliation': 'Yale Cancer Center, Smilow Cancer Hospital, New Haven, CT, USA. Electronic address: charles.fuchs@yale.edu.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Shitara', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Di Bartolomeo', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Istituto Oncologico Veneto-IRCCS, Padova, Italy.'}, {'ForeName': 'Salah-Eddin', 'Initials': 'SE', 'LastName': 'Al-Batran', 'Affiliation': 'Institute of Clinical Cancer Research at Krankenhaus Nordwest, UCT-University Cancer Center, Frankfurt, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'University Hospitals Gasthuisberg, Leuven and KULeuven, Belgium.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Ilson', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Alsina', 'Affiliation': ""Vall d'Hebron University Hospital and Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Chau', 'Affiliation': 'Royal Marsden Hospital, Sutton, Surrey, United Kingdom.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Lacy', 'Affiliation': 'Yale Cancer Center, Smilow Cancer Hospital, New Haven, CT, USA.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Ducreux', 'Affiliation': 'Gustave Roussy Cancer Centre, Grand Paris, Villejuif, France; Université Paris-Saclay, France.'}, {'ForeName': 'Guillermo Ariel', 'Initials': 'GA', 'LastName': 'Mendez', 'Affiliation': 'Hospital Universitario Fundacion Favaloro, Buenos Aires, Argentina.'}, {'ForeName': 'Alejandro Molina', 'Initials': 'AM', 'LastName': 'Alavez', 'Affiliation': 'Center for Clinical Care and Research in Oncology, Merida, Yucatan, Mexico.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Takahari', 'Affiliation': 'The Cancer Institute Hospital of JFCR, Tokyo, Japan.'}, {'ForeName': 'Wasat', 'Initials': 'W', 'LastName': 'Mansoor', 'Affiliation': 'The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Enzinger', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Gorbounova', 'Affiliation': 'N N Blokhin Russian Cancer Research Center, Moscow, Russia.'}, {'ForeName': 'Zev A', 'Initials': 'ZA', 'LastName': 'Wainberg', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Hegewisch-Becker', 'Affiliation': 'HOPE-Practice for Oncology, Hamburg, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ferry', 'Affiliation': 'Eli Lilly and Company, New York City, NY, USA.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Carlesi', 'Affiliation': 'Eli Lilly Italia, Florence, Italy.'}, {'ForeName': 'Mayukh', 'Initials': 'M', 'LastName': 'Das', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Manish A', 'Initials': 'MA', 'LastName': 'Shah', 'Affiliation': 'Weill Cornell Medical College, NY, USA; New York Presbyterian Hospital, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(18)30791-5']
1421,31693128,"Effect of Mailed Human Papillomavirus Test Kits vs Usual Care Reminders on Cervical Cancer Screening Uptake, Precancer Detection, and Treatment: A Randomized Clinical Trial.","Importance


In the United States, more than 50% of cervical cancers are diagnosed in underscreened women. Cervical cancer screening guidelines now include primary human papillomavirus (HPV) testing as a recommended strategy. Home-based HPV self-sampling is a viable option for increasing screening compliance and effectiveness; however, US data are needed to inform health care system implementation.
Objective


To evaluate effectiveness of mailed HPV self-sampling kits vs usual care reminders for in-clinic screening to increase detection and treatment of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and uptake of cervical cancer screening.
Design, Setting, and Participants


Randomized clinical trial conducted in Kaiser Permanente Washington, a US integrated health care delivery system. Women aged 30 to 64 years with health plan enrollment for 3 years and 5 months or more, a primary care clinician, no Papanicolaou test within 3 years and 5 months, and no hysterectomy were identified through electronic medical records and enrolled from February 25, 2014, to August 29, 2016, with follow-up through February 26, 2018.
Interventions


The control group received usual care (annual patient reminders and ad hoc outreach from primary care clinics). The intervention group received usual care plus a mailed HPV self-sampling kit.
Main Outcomes and Measures


Two primary outcomes were (1) CIN2+ detection within 6 months of screening and (2) treatment within 6 months of CIN2+ detection. Screening uptake within 6 months of randomization was a secondary outcome.
Results


A total of 19 851 women (mean [SD] age, 50.1 [9.5] years) were included, with 9960 randomized to the intervention group and 9891 randomized to the control group. All women randomized were included in analysis. In the intervention group, 12 participants with CIN2+ were detected compared with 8 in the control group (relative risk, 1.49; 95% CI, 0.61-3.64) and 12 cases were treated vs 7 in the control group (relative risk, 1.70; 95% CI, 0.67-4.32). Screening uptake was higher in the intervention group (2618 participants [26.3%] vs 1719 participants [17.4%]; relative risk, 1.51; 95% CI, 1.43-1.60).
Conclusions and Relevance


Mailing HPV kits to underscreened women increased screening uptake compared with usual care alone, with no significant differences in precancer detection or treatment. Results support the feasibility of mailing HPV kits to women who are overdue for screening as an outreach strategy to increase screening uptake in US health care systems. Efforts to increase kit uptake and follow-up of positive results are warranted to maximize detection and treatment of CIN2+.
Trial Registration


ClinicalTrials.gov identifier: NCT02005510.",2019,"Screening uptake was higher in the intervention group (2618 participants [26.3%] vs 1719 participants [17.4%]; relative risk, 1.51; 95% CI, 1.43-1.60).
","['Women aged 30 to 64 years with health plan enrollment for 3 years and 5 months or more, a primary care clinician, no Papanicolaou test within 3 years and 5 months, and no hysterectomy were identified through electronic medical records and enrolled from February 25, 2014, to August 29, 2016, with follow-up through February 26, 2018', 'A total of 19\u202f851 women (mean [SD] age, 50.1 [9.5] years) were included, with 9960 randomized to the intervention group and 9891 randomized to the control group']","['usual care plus a mailed HPV self-sampling kit', 'mailed HPV self-sampling kits vs usual care reminders', 'Mailed Human Papillomavirus Test Kits vs Usual Care Reminders', 'usual care (annual patient reminders and ad hoc outreach from primary care clinics']","['Screening uptake', 'Cervical Cancer Screening Uptake, Precancer Detection', 'CIN2+ detection within 6 months of screening and (2) treatment within 6 months of CIN2+ detection', 'cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and uptake of cervical cancer screening']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C3541459', 'cui_str': 'Papanicolaou Smear'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C1272835', 'cui_str': 'Test kit'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}]","[{'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0349459', 'cui_str': 'Cervical intraepithelial neoplasia grade 2 (disorder)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}]",2618.0,0.115907,"Screening uptake was higher in the intervention group (2618 participants [26.3%] vs 1719 participants [17.4%]; relative risk, 1.51; 95% CI, 1.43-1.60).
","[{'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Winer', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle.'}, {'ForeName': 'Jasmin A', 'Initials': 'JA', 'LastName': 'Tiro', 'Affiliation': 'Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Diana L', 'Initials': 'DL', 'LastName': 'Miglioretti', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Beatty', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle.'}, {'ForeName': 'Hongyuan', 'Initials': 'H', 'LastName': 'Gao', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle.'}, {'ForeName': 'Kilian', 'Initials': 'K', 'LastName': 'Kimbel', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Thayer', 'Affiliation': 'Kaiser Permanente Washington, Renton.'}, {'ForeName': 'Diana S M', 'Initials': 'DSM', 'LastName': 'Buist', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.14729']
1422,31646668,Influence of Ibuprofen on Bone Healing After Colles' Fracture: A Randomized Controlled Clinical Trial.,"Non-steroidal anti-inflammatory drugs (NSAIDs) may delay bone healing. [Therefore, it is important to establish whether NSAID preparations delay bone healing and what correlations, if any, exist between different bone studies-DEXA-scanning, bone markers, roentgenology controls, and histological examination of newly formed bone]. The purpose of this prospective controlled study was to investigate whether ibuprofen affects bone mineral density, turnover biomarkers, and histomorphometric characteristics of the callus after a Colles' fracture. This study was a single-center, triple-blinded, randomized clinical trial. Ninety-five patients (80 females) with displaced Colles' fracture, median age 65 (range 40-85) years were included in the study and operated on by external fixation from June 2012 through to June 2015. Eighty-nine patients received interventional medicine and 83 completed the 1-year follow-up. The 7-day ibuprofen group received 600 mg of ibuprofen three times a day (N = 29), the 3-day ibuprofen group received ibuprofen for 3 days (N = 30) and a placebo for the following 4 days, and finally, the placebo group received a placebo for 7 days (N = 30). The primary outcome was the difference in bone mineral density between the ultra-distal region of the injured and non-injured radius at 3 months after surgery. The histomorphometric outcomes included the assessment of callus tissue volume and surface fractions at 6 weeks postoperatively. The biomarkers Osteocalcin and CrossLaps were measured at baseline, 1 week, 2 weeks, 6 weeks, 3 months, and 1 year. We included the results of the dropped-out patients in the intention to treat analysis. There was no difference between treatment groups in bone mineral density, histomorphometric estimations, and changes in bone biomarkers. These findings may offer an indication of ibuprofen as a bone-safe analgesic treatment in an acute fracture-phase. © 2019 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 38:545-554, 2020.",2020,"There was no difference between treatment groups in bone mineral density, histomorphometric estimations and changes in bone biomarkers.","[""after Colles' fracture "", ""Ninety-five patients (eighty females) with displaced Colles' fracture, median age 65 (range 40-85) years were included in the study and operated on by external fixation from June 2012 through to June 2015"", '89 patients received']","['interventional medicine', 'ibuprofen', 'placebo', '3-days ibuprofen', 'Nonsteroidal anti-inflammatory drugs (NSAIDs']","['biomarkers Osteocalcin and CrossLaps', 'bone mineral density, turnover biomarkers, and histomorphometric characteristics', 'callus tissue volume- and surface fractions', 'bone healing', 'bone mineral density, histomorphometric estimations and changes in bone biomarkers', 'bone mineral density between the ultra-distal region of the injured and non-injured radius']","[{'cui': 'C0009353', 'cui_str': ""Colles' Fracture""}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0407333', 'cui_str': 'Fixation of fracture using external fixator (procedure)'}, {'cui': 'C0332273', 'cui_str': 'Through (qualifier value)'}]","[{'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C0671677', 'cui_str': 'CrossLaps peptide'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0443331', 'cui_str': 'Turnover technique (qualifier value)'}, {'cui': 'C0376154', 'cui_str': 'Callosities'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C1306504', 'cui_str': 'Radius (qualifier value)'}]",95.0,0.441613,"There was no difference between treatment groups in bone mineral density, histomorphometric estimations and changes in bone biomarkers.","[{'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Aliuskevicius', 'Affiliation': 'Department of Orthopedic Surgery, Clinic Orto-Head, Aalborg University Hospital, 18-22 Hobrovej, DK-9000, Aalborg, Denmark.'}, {'ForeName': 'Svend Erik', 'Initials': 'SE', 'LastName': 'Østgaard', 'Affiliation': 'Department of Orthopedic Surgery, Clinic Orto-Head, Aalborg University Hospital, 18-22 Hobrovej, DK-9000, Aalborg, Denmark.'}, {'ForeName': 'Ellen Margrethe', 'Initials': 'EM', 'LastName': 'Hauge', 'Affiliation': 'Department of Rheumatology, Aarhus University Hospital, 99 Palle Juul-Jensens Boulevard, DK-8200, Aarhus N, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vestergaard', 'Affiliation': 'Department of Clinical Medicine, Aalborg University, 15 Sdr. Skovvej, DK-9000, Aalborg, Denmark.'}, {'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Orthopedic Surgery, Clinic Orto-Head, Aalborg University Hospital, 18-22 Hobrovej, DK-9000, Aalborg, Denmark.'}]",Journal of orthopaedic research : official publication of the Orthopaedic Research Society,['10.1002/jor.24498']
1423,31644933,Brain activation patterns associated with paragraph learning in persons with multiple sclerosis: The MEMREHAB trial.,"The modified Story Memory Technique (mSMT) is a memory rehabilitation program that combines training in visualization and context formation to improve learning and memory. Previous studies have shown improvement in learning and memory in individuals with multiple sclerosis (MS) after undergoing the mSMT, including changes in brain activity related to working memory and word encoding. The current study examined changes in brain activity in 16 individuals diagnosed with MS (n  treatment  = 6; n  placebo control  = 10) when they were presented with to-be-remembered information within a meaningful context (i.e. a paragraph) from before to after mSMT treatment. We expected treatment-related changes in brain activation in the language network (LAN), default mode network (DMN), and executive control network (ECN). Consistent with this prediction, fMRI results revealed reduced brain activation in the LAN, DMN and ECN after completing the mSMT treatment in the context of paragraph learning. While no significant behavioral changes were observed, a marginally significant improvement with a large effect size was noted between baseline and follow-up performance on the Rivermead Behavioral Memory Test in persons who completed treatment. Results are discussed in terms of the impact of imagery training on patterns of cerebral activation when learning words presented within a context.",2020,"We expected treatment-related changes in brain activation in the language network (LAN), default mode network (DMN), and executive control network (ECN).","['persons with multiple sclerosis', '16 individuals diagnosed with MS (n treatment \u202f=\u202f6; n placebo control \u202f=\u202f10', 'individuals with multiple sclerosis (MS']","['imagery training', 'paragraph learning', 'modified Story Memory Technique (mSMT']","['brain activity', 'behavioral changes', 'brain activation']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}]",16.0,0.0162649,"We expected treatment-related changes in brain activation in the language network (LAN), default mode network (DMN), and executive control network (ECN).","[{'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Boukrina', 'Affiliation': 'Center for Stroke Rehabilitation Research, Kessler Foundation, West Orange, NJ, USA; Department of Physical Medicine and Rehabilitation, Rutgers-New Jersey Medical School Newark, NJ, USA.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Dobryakova', 'Affiliation': 'Center for Traumatic Brain Injury Research, Kessler Foundation, East Hanover, NJ, USA; Department of Physical Medicine and Rehabilitation, Rutgers-New Jersey Medical School Newark, NJ, USA.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Schneider', 'Affiliation': 'Center for Traumatic Brain Injury Research, Kessler Foundation, East Hanover, NJ, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'DeLuca', 'Affiliation': 'Center for Neuropsychology and Neuroscience Research, Kessler Foundation, West Orange, NJ, USA; Department of Physical Medicine and Rehabilitation, Rutgers-New Jersey Medical School Newark, NJ, USA.'}, {'ForeName': 'Nancy D', 'Initials': 'ND', 'LastName': 'Chiaravalloti', 'Affiliation': 'Center for Traumatic Brain Injury Research, Kessler Foundation, East Hanover, NJ, USA; Center for Neuropsychology and Neuroscience Research, Kessler Foundation, West Orange, NJ, USA; Department of Physical Medicine and Rehabilitation, Rutgers-New Jersey Medical School Newark, NJ, USA. Electronic address: nchiaravalloti@kesslerfoundation.org.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2019.09.008']
1424,30681196,Nocturnal Olfactory Stimulation for Improvement of Sleep Quality in Patients With Posttraumatic Stress Disorder: A Randomized Exploratory Intervention Trial.,"Posttraumatic stress disorder (PTSD) is characterized by sleep impairment and nightmares. As pleasant odors presented during sleep affect the emotional tone of dreams without inducing arousal, we investigated whether sleep patterns in PTSD can be improved via nocturnal olfactory stimulation. Participants were 40 inpatients with PTSD (n = 35 women; age range: 20-59 years) who completed a randomized, patient-blind, placebo-controlled trial. Baseline measurement for 5 consecutive nights was followed by a 5-night experimental intervention or placebo trial. During the intervention, patients received nocturnal stimulation with a pleasant odor (odor condition) or clean air (placebo condition) via an olfactometer that delivered inspiration-triggered stimuli in a nasal tube or via an odorized nasal clip. After each night, the patients completed standardized questionnaires that assessed sleep parameters and dream content. Each night, sleep efficiency, sleep onset latency, and wakefulness after sleep onset were monitored with a motion biosensor. Baseline assessment revealed that PTSD severity was associated with poorer sleep outcomes. An interaction effect showed that nocturnal odorization affected dream intensity. Post hoc tests revealed an improvement in the group that used the nasal clip as compared to baseline, d = 0.68. No negative effects were observed after odorization with the nasal clip. Considering the limited sample size, the study indicates that nocturnal olfactory stimulation may serve as a low-cost concomitant intervention to improve sleep quality in PTSD.",2019,"Post hoc tests revealed an improvement in the group that used the nasal clip as compared to baseline, d = 0.68.","['Patients With Posttraumatic Stress Disorder', 'Participants were 40 inpatients with PTSD (n\xa0=\xa035 women; age range: 20-59\xa0years', 'Posttraumatic stress disorder (PTSD']","['Nocturnal Olfactory Stimulation', 'placebo', 'nocturnal stimulation with a pleasant odor (odor condition) or clean air (placebo condition) via an olfactometer that delivered inspiration-triggered stimuli in a nasal tube or via an odorized nasal clip']","['sleep efficiency, sleep onset latency, and wakefulness after sleep onset', 'PTSD severity', 'Sleep Quality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0439826', 'cui_str': 'Olfactory (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0028884', 'cui_str': 'Odors'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0175722', 'cui_str': 'Clip'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}, {'cui': 'C0043012', 'cui_str': 'Wakefulnesses'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",40.0,0.100148,"Post hoc tests revealed an improvement in the group that used the nasal clip as compared to baseline, d = 0.68.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Schäfer', 'Affiliation': 'Department of Psychotherapy and Psychosomatic Medicine, Technische Universität, Dresden, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Schellong', 'Affiliation': 'Department of Psychotherapy and Psychosomatic Medicine, Technische Universität, Dresden, Germany.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Hähner', 'Affiliation': 'Smell and Taste Clinic, Department of Otorhinolaryngology, Technische Universität, Dresden, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Weidner', 'Affiliation': 'Department of Psychotherapy and Psychosomatic Medicine, Technische Universität, Dresden, Germany.'}, {'ForeName': 'Karl-Bernd', 'Initials': 'KB', 'LastName': 'Hüttenbrink', 'Affiliation': 'Department of Otorhinolaryngology, University of Cologne, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Trautmann', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität, Dresden, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hummel', 'Affiliation': 'Smell and Taste Clinic, Department of Otorhinolaryngology, Technische Universität, Dresden, Germany.'}, {'ForeName': 'Ilona', 'Initials': 'I', 'LastName': 'Croy', 'Affiliation': 'Department of Psychotherapy and Psychosomatic Medicine, Technische Universität, Dresden, Germany.'}]",Journal of traumatic stress,['10.1002/jts.22359']
1425,30639444,Prospective association of white matter hyperintensity volume and frailty in older adults.,"BACKGROUND


Frailty is a prevalent geriatric condition and its association with brain health is still weakly investigated. The objective of this study was to examine whether brain white matter hyperintensities (WMH) were related to longitudinal changes in frailty severity in community-dwelling older adults.
METHODS


113 community-dwelling older adults, aged 70 years and over, enrolled in the placebo group from the 3-year Multidomain Alzheimer's Preventive Trial (MAPT). Frailty was assessed using Fried's frailty phenotype as an ordinal variable (range from 0 to 5, higher is worse) at baseline, 6, 12, 24 and 36 months. We obtained brain WMH data using magnetic resonance imaging (MRI) at the first and last year of the trial. The progression of WMH volume was evaluated.
RESULTS


We included 113 baseline and 83 follow-up MRIs in this study. The median baseline WMH volume was 10.6 (6.0, 15.0) cm 3  and the median progression of WMH was 1.1 (-0.3, 2.2) cm 3 . Our results indicate that people with higher baseline WMH had a 6% increased likelihood of increasing their frailty phenotype score (adjusted OR: 1.06, (1.00-1.12, p = 0.036)). No associations were found between the progression of WMH (slow vs. fast) volume accumulation and frailty severity.
CONCLUSION


WMH were associated with frailty severity over time. Why the progression of WMH was not associated with changes in frailty severity requires further investigation.",2019,"Our results indicate that people with higher baseline WMH had a 6% increased likelihood of increasing their frailty phenotype score (adjusted OR: 1.06, (1.00-1.12, p = 0.036)).","['community-dwelling older adults', ""113 community-dwelling older adults, aged 70\u202fyears and over, enrolled in the placebo group from the 3-year Multidomain Alzheimer's Preventive Trial (MAPT"", 'brain white matter hyperintensities (WMH', 'older adults']",['magnetic resonance imaging (MRI'],"['likelihood of increasing their frailty phenotype score', 'progression of WMH (slow vs. fast) volume accumulation and frailty severity', 'progression of WMH volume', 'median baseline WMH volume', 'median progression of WMH']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C2938912'}]","[{'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]","[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",113.0,0.0510881,"Our results indicate that people with higher baseline WMH had a 6% increased likelihood of increasing their frailty phenotype score (adjusted OR: 1.06, (1.00-1.12, p = 0.036)).","[{'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Maltais', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse, 37 allée Jules Guesdes, 31000 Toulouse, France. Electronic address: mathieu.maltais@usherbrooke.ca.'}, {'ForeName': 'Philipe', 'Initials': 'P', 'LastName': 'de Souto Barreto', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse, 37 allée Jules Guesdes, 31000 Toulouse, France; UMR INSERM, 1027 University of Toulouse III, Faculté de médecine, 37 allées Jules Guesde, 31000 Toulouse, France.'}, {'ForeName': 'So Young', 'Initials': 'SY', 'LastName': 'Moon', 'Affiliation': 'Department of Neurology, Ajou University School of Medicine, 5-1, Yeongtong-gu, Suwon-si, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rolland', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse, 37 allée Jules Guesdes, 31000 Toulouse, France; UMR INSERM, 1027 University of Toulouse III, Faculté de médecine, 37 allées Jules Guesde, 31000 Toulouse, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vellas', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse, 37 allée Jules Guesdes, 31000 Toulouse, France; UMR INSERM, 1027 University of Toulouse III, Faculté de médecine, 37 allées Jules Guesde, 31000 Toulouse, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Experimental gerontology,['10.1016/j.exger.2019.01.007']
1426,32407710,"The effect of lactoferrin supplementation on death or major morbidity in very low birthweight infants (LIFT): a multicentre, double-blind, randomised controlled trial.","BACKGROUND


Very low birthweight or preterm infants are at increased risk of adverse outcomes including sepsis, necrotising enterocolitis, and death. We assessed whether supplementing the enteral diet of very low-birthweight infants with lactoferrin, an antimicrobial protein, reduces all-cause mortality or major morbidity.
METHODS


We did a multicentre, double-blind, pragmatic, randomised superiority trial in 14 Australian and two New Zealand neonatal intensive care units. Infants born weighing less than 1500 g and aged less than 8 days, were eligible and randomly assigned (1:1) using minimising web-based randomisation to receive once daily 200 mg/kg pasteurised bovine lactoferrin supplements or no lactoferrin supplement added to breast or formula milk until 34 weeks' post-menstrual age (or for 2 weeks, if longer), or until discharge from the study hospital if that occurred first. Designated nurses preparing the daily feeds were not masked to group assignment, but other nurses, doctors, parents, caregivers, and investigators were unaware. The primary outcome was survival to hospital discharge or major morbidity (defined as brain injury, necrotising enterocolitis, late-onset sepsis at 36 weeks' post-menstrual age, or retinopathy treated before discharge) assessed in the intention-to-treat population. Safety analyses were by treatment received. We also did a prespecified, PRISMA-compliant meta-analysis, which included this study and other relevant randomised controlled trials, to estimate more precisely the effects of lactoferrin supplementation on late-onset sepsis, necrotising enterocolitis, and survival. This trial is registered with the Australian and New Zealand Clinical Trials Registry, ACTRN12611000247976.
FINDINGS


Between June 27, 2014, and Sept 1, 2017, we recruited 1542 infants; 771 were assigned to the intervention group and 771 to the control group. One infant who had consent withdrawn before beginning lactoferrin treatment was excluded from analysis. In-hospital death or major morbidity occurred in 162 (21%) of 770 infants in the intervention group and in 170 (22%) of 771 infants in the control group (relative risk [RR] 0·95, 95% CI 0·79-1·14; p=0·60). Three suspected unexpected serious adverse reactions occurred; two in the lactoferrin group, namely unexplained late jaundice and inspissated milk syndrome, but were not attributed to the intervention and one in the control group had fatal inspissated milk syndrome. Our meta-analysis identified 13 trials completed before Feb 18, 2020, including this Article, in 5609 preterm infants. Lactoferrin supplements significantly reduced late-onset sepsis (RR 0·79, 95% CI 0·71-0·88; p<0·0001; I 2 =58%), but not necrotising enterocolitis or all-cause mortality.
INTERPRETATION


Lactoferrin supplementation did not improve death or major morbidity in this trial, but might reduce late-onset sepsis, as found in our meta-analysis of over 5000 infants. Future collaborative studies should use products with demonstrated biological activity, be large enough to detect moderate and clinically important effects reliably, and assess greater doses of lactoferrin in infants at increased risk, such as those not exclusively receiving breastmilk or infants of extremely low birthweight.
FUNDING


Australian National Health and Medical Research Council.",2020,"Lactoferrin supplements significantly reduced late-onset sepsis (RR 0·79, 95% CI 0·71-0·88; p<0·0001; I 2 =58%), but not necrotising enterocolitis or all-cause mortality.
INTERPRETATION


Lactoferrin supplementation did not improve death or major morbidity in this trial, but might reduce late-onset sepsis, as found in our meta-analysis of over 5000 infants.","['Infants born weighing less than 1500 g and aged less than 8 days, were eligible and randomly assigned (1:1) using', '14 Australian and two New Zealand neonatal intensive care units', '5609 preterm infants', 'One infant who had consent withdrawn before beginning lactoferrin treatment was excluded from analysis', '1542 infants; 771 were assigned to the intervention group and 771 to the control group', 'very low birthweight infants (LIFT', 'Between June 27, 2014, and Sept 1, 2017']","['Lactoferrin supplements', 'lactoferrin supplementation', 'lactoferrin', ""minimising web-based randomisation to receive once daily 200 mg/kg pasteurised bovine lactoferrin supplements or no lactoferrin supplement added to breast or formula milk until 34 weeks' post-menstrual age""]","['death or major morbidity', 'hospital death or major morbidity', 'fatal inspissated milk syndrome', 'unexplained late jaundice and inspissated milk syndrome', ""survival to hospital discharge or major morbidity (defined as brain injury, necrotising enterocolitis, late-onset sepsis at 36 weeks' post-menstrual age, or retinopathy treated before discharge) assessed in the intention-to-treat population"", 'late-onset sepsis', 'late-onset sepsis, necrotising enterocolitis, and survival']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}]","[{'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C1440867', 'cui_str': 'Bovine lactoferrin'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0452742', 'cui_str': 'Formula milk'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0277608', 'cui_str': 'Death in hospital'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0022346', 'cui_str': 'Jaundice'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035309', 'cui_str': 'Retinal disorder'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",5609.0,0.688179,"Lactoferrin supplements significantly reduced late-onset sepsis (RR 0·79, 95% CI 0·71-0·88; p<0·0001; I 2 =58%), but not necrotising enterocolitis or all-cause mortality.
INTERPRETATION


Lactoferrin supplementation did not improve death or major morbidity in this trial, but might reduce late-onset sepsis, as found in our meta-analysis of over 5000 infants.","[{'ForeName': 'William O', 'Initials': 'WO', 'LastName': 'Tarnow-Mordi', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia. Electronic address: william.tarnow-mordi@ctc.usyd.edu.au.'}, {'ForeName': 'Mohamed E', 'Initials': 'ME', 'LastName': 'Abdel-Latif', 'Affiliation': 'Australian National University, Canberra, ACT, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Pammi', 'Affiliation': 'Texas Medical Centre, Houston, TX, USA.'}, {'ForeName': 'Kristy', 'Initials': 'K', 'LastName': 'Robledo', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Manzoni', 'Affiliation': 'Nuovo Ospedale Degli Infermi, Ponderano, Italy.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Osborn', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Lui', 'Affiliation': 'University of New South Wales, Kensington, NSW, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Keech', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Hague', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Alpana', 'Initials': 'A', 'LastName': 'Ghadge', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Javeed', 'Initials': 'J', 'LastName': 'Travadi', 'Affiliation': 'University of Newcastle, Newcastle, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Brown', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Darlow', 'Affiliation': 'University of Otago, Otago, New Zealand.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Liley', 'Affiliation': 'University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Margo', 'Initials': 'M', 'LastName': 'Pritchard', 'Affiliation': 'University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Kochar', 'Affiliation': 'University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Isaacs', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Gordon', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Askie', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Cruz', 'Affiliation': 'Miracle Babies Foundation, Chipping Norton, NSW, Australia.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Schindler', 'Affiliation': 'University of New South Wales, Kensington, NSW, Australia.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Dixon', 'Affiliation': 'University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Girish', 'Initials': 'G', 'LastName': 'Deshpande', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tracy', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Schofield', 'Affiliation': 'Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Austin', 'Affiliation': 'University of Otago, Otago, New Zealand.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sinn', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'R John', 'Initials': 'RJ', 'LastName': 'Simes', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(20)30093-6']
1427,29803703,Effects of intra-resuscitation antiarrhythmic administration on rearrest occurrence and intra-resuscitation ECG characteristics in the ROC ALPS trial.,"BACKGROUND


Intra-resuscitation antiarrhythmic drugs may improve resuscitation outcomes, in part by avoiding rearrest, a condition associated with poor out-of-hospital cardiac arrest (OHCA) outcomes. However, antiarrhythmics may also alter defibrillation threshold. The objective of this study was to investigate the relationship between rearrest and intra-resuscitation antiarrhythmic drugs in the context of the Resuscitation Outcomes Consortium (ROC) amiodarone, lidocaine, and placebo (ALPS) trial.
HYPOTHESIS


Rearrest rates would be lower in cases treated with amiodarone or lidocaine, versus saline placebo, prior to first return of spontaneous circulation (ROSC). We also hypothesized antiarrhythmic effects would be quantifiable through analysis of the prehospital electrocardiogram.
METHODS


We conducted a secondary analysis of the ROC ALPS trial. Cases that first achieved prehospital ROSC after randomized administration of study drug were included in the analysis. Rearrest, defined as loss of pulses following ROSC, was ascertained from emergency medical services records. Rearrest rate was calculated overall, as well as by ALPS treatment group. Multivariable logistic regression models were constructed to assess the association between treatment group and rearrest, as well as rearrest and both survival to hospital discharge and survival with neurologic function. Amplitude spectrum area, median slope, and centroid frequency of the ventricular fibrillation (VF) ECG were calculated and compared across treatment groups.
RESULTS


A total of 1144 (40.4%) cases with study drug prior to first ROSC were included. Rearrest rate was 44.0% overall; 42.9% for placebo, 45.7% for lidocaine, and 43.0% for amiodarone. In multivariable logistic regression models, ALPS treatment group was not associated with rearrest, though rearrest was associated with poor survival and neurologic outcomes. AMSA and median slope measures of the first available VF were associated with rearrest case status, while median slope and centroid frequency were associated with ALPS treatment group.
CONCLUSION


Rearrest rates did not differ between antiarrhythmic and placebo treatment groups. ECG waveform characteristics were correlated with treatment group and rearrest. Rearrest was inversely associated with survival and neurologic outcomes.",2018,"Rearrest rate was 44.0% overall; 42.9% for placebo, 45.7% for lidocaine, and 43.0% for amiodarone.",['A total of 1144 (40.4%) cases with study drug prior to first ROSC were included'],"['placebo', 'amiodarone or lidocaine', 'amiodarone', 'lidocaine', 'saline placebo', 'amiodarone, lidocaine, and placebo (ALPS', 'intra-resuscitation antiarrhythmic']","['ECG waveform characteristics', 'Rearrest rate', 'poor survival and neurologic outcomes', 'Amplitude spectrum area, median slope, and centroid frequency of the ventricular fibrillation (VF) ECG', 'AMSA and median slope measures', 'Rearrest rates', 'rearrest occurrence and intra-resuscitation ECG characteristics', 'survival and neurologic outcomes', 'median slope and centroid frequency']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0002598', 'cui_str': 'Amiodarone'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]","[{'cui': 'C0428732', 'cui_str': 'Observation of ECG waveform'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0042510', 'cui_str': 'Ventricular Fibrillation'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0002699', 'cui_str': 'Amsacrine'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]",1144.0,0.119912,"Rearrest rate was 44.0% overall; 42.9% for placebo, 45.7% for lidocaine, and 43.0% for amiodarone.","[{'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Salcido', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA, United States. Electronic address: salcidodd@upmc.edu.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Schmicker', 'Affiliation': 'University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Noah', 'Initials': 'N', 'LastName': 'Kime', 'Affiliation': 'University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Jason E', 'Initials': 'JE', 'LastName': 'Buick', 'Affiliation': ""Rescu, Li Ka Shing Knowledge Institute, St. Michael's Hospital University of Toronto, Toronto, ON, Canada; Institute of Health Policy, Management and Evaluation, Faculty of Medicine, University of Toronto, Toronto ON, Canada.""}, {'ForeName': 'Sheldon', 'Initials': 'S', 'LastName': 'Cheskes', 'Affiliation': 'Sunnybrook Center for Prehospital Medicine, Toronto, ON, Canada.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Grunau', 'Affiliation': 'University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Zellner', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI, United States.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Zive', 'Affiliation': 'Oregon Health Sciences University, Portland, OR, United States.'}, {'ForeName': 'Tom P', 'Initials': 'TP', 'LastName': 'Aufderheide', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI, United States.'}, {'ForeName': 'Allison C', 'Initials': 'AC', 'LastName': 'Koller', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Herren', 'Affiliation': 'University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Nuttall', 'Affiliation': 'Oregon Health Sciences University, Portland, OR, United States.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Sundermann', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Menegazzi', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Resuscitation,['10.1016/j.resuscitation.2018.05.028']
1428,30611727,Effects of short-term resistance training on endothelial function and inflammation markers in elderly patients with type 2 diabetes: A randomized controlled trial.,"PURPOSE


To evaluate the effects of 12-weeks of strength training on endothelial function and inflammatory markers in elderly individuals with T2DM.
METHODS


Forty-four elderly patients with T2DM were screened for participation. After completion of the baseline assessment, participants were randomly assigned to either the resistance training group (RT) or an active control group (AC). Inflammatory (TNF-α, IL-6, IL-1β, IL-10 and CRP) and blood lipid profiles, glycated hemoglobin, basal artery diameter and flow mediated dilation were evaluated before and after the intervention. Comparisons between groups were obtained from the generalized estimation equation and all tests were two-tailed and the alpha level for significance set at 0.05.
RESULTS


TNF-α and IL-1β were decreased in both groups, while no interactions were found for flow mediated dilation and basal artery diameter. No significant differences were found for blood lipid profile and glycated hemoglobin for both groups after the intervention period.
CONCLUSIONS


No significant changes were found between the RT and AC groups, regarding inflammatory profile and endothelial function, which does not prove the superiority of this intervention model in the studied period.",2019,"Inflammatory (TNF-α, IL-6, IL-1β, IL-10 and CRP) and blood lipid profiles, glycated hemoglobin, basal artery diameter and flow mediated dilation were evaluated before and after the intervention.","['elderly patients with type 2 diabetes', 'Forty-four elderly patients with T2DM were screened for participation', 'elderly individuals with T2DM']","['resistance training group (RT) or an active control group (AC', 'strength training', 'short-term resistance training']","['flow mediated dilation and basal artery diameter', 'Inflammatory (TNF-α, IL-6, IL-1β, IL-10 and CRP) and blood lipid profiles, glycated hemoglobin, basal artery diameter and flow mediated dilation', 'blood lipid profile and glycated hemoglobin', 'endothelial function and inflammation markers', 'TNF-α and IL-1β', 'inflammatory profile and endothelial function', 'endothelial function and inflammatory markers']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]","[{'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0003842', 'cui_str': 'Arteries'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",44.0,0.0301827,"Inflammatory (TNF-α, IL-6, IL-1β, IL-10 and CRP) and blood lipid profiles, glycated hemoglobin, basal artery diameter and flow mediated dilation were evaluated before and after the intervention.","[{'ForeName': 'Anderson', 'Initials': 'A', 'LastName': 'Rech', 'Affiliation': 'Life Sciences Center, Universidade de Caxias do Sul, Caxias do Sul, RS 95070-560, Brazil; Exercise Research Laboratory, School of Physical Education, Phisiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS 90690-200, Brazil. Electronic address: arech16@ucs.br.'}, {'ForeName': 'Cíntia Ehlers', 'Initials': 'CE', 'LastName': 'Botton', 'Affiliation': 'Exercise Research Laboratory, School of Physical Education, Phisiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS 90690-200, Brazil; Hospital de Clínicas de Porto Alegre, National Institute of Science and Technology for Health Technology Assessment (IATS), Universidade Federal do Rio Grande do Sul, Porto Alegre, RS 90035-007, Brazil.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Lopez', 'Affiliation': 'Exercise Research Laboratory, School of Physical Education, Phisiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS 90690-200, Brazil.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Quincozes-Santos', 'Affiliation': 'Departamento de Bioquímica, Programa de Pós-Graduação em Ciências Biológicas: Bioquímica, Instituto de Ciências Básicas da Saúde, Universidade Federal do Rio Grande do Sul, Rua Ramiro Barcelos, 2600-Anexo, Bairro Santa Cecília, Porto Alegre, RS 90035-003, Brazil.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Umpierre', 'Affiliation': 'Hospital de Clínicas de Porto Alegre, National Institute of Science and Technology for Health Technology Assessment (IATS), Universidade Federal do Rio Grande do Sul, Porto Alegre, RS 90035-007, Brazil.'}, {'ForeName': 'Ronei Silveira', 'Initials': 'RS', 'LastName': 'Pinto', 'Affiliation': 'Exercise Research Laboratory, School of Physical Education, Phisiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS 90690-200, Brazil.'}]",Experimental gerontology,['10.1016/j.exger.2019.01.003']
1429,30270717,Effects of meal replacement therapy on metabolic outcomes in Thai patients with type 2 diabetes: A randomized controlled trial.,"BACKGROUND


A meal replacement (MR) with a low glycemic index (GI) is possibly beneficial for glycemic control. However, the effects of MR on diabetes mellitus have not been studied among Thai patients with type 2 diabetes (T2DM).
AIM


To compare metabolic outcomes between T2DM patients receiving the new MR formula (ONCE PRO) and normal controlled diets.
METHODS


A multicenter, open-labeled, randomized controlled trial was conducted. Eligible patients received either ONCE PRO for one meal daily with controlled diets or only controlled diets for 3 months. The differences in metabolic profile between the baseline and end point of each group and between groups were measured.
RESULTS


110 participants were enrolled; the mean difference and standard deviation in hemoglobin A1C (HbA1c) (%) from baseline were -0.21 ± 0.78 ( p  = 0.060) and -0.27 ± 0.60 ( p  = 0.001) in the MR and control groups, respectively; however, there was no significant difference between groups ( p  = 0.637). Patients consuming a MR instead of breakfast had a significant decrease in HbA1c ( p  = 0.040). Body weight (BW) and body mass index (BMI) were significantly reduced in both groups. There were no significant change in waist circumference, fasting plasma glucose, total cholesterol and triglycerides. Low-density lipoprotein cholesterol (LDL-C) was significantly decreased in the MR group compared with the control group ( p  = 0.049).
CONCLUSIONS


Short-term conventional diet control and the low-GI MR product were associated with a decreased BW and BMI. Changes in the other metabolic outcomes, HbA1c, total cholesterol and triglycerides, were comparable despite ONCE PRO as the MR having a better effect on LDL-C lowering.",2018,Patients consuming a MR instead of breakfast had a significant decrease in HbA1c ( p = 0.040).,"['110 participants', 'Thai patients with type 2 diabetes (T2DM', 'Thai patients with type 2 diabetes', 'T2DM patients receiving the new MR formula (ONCE PRO) and normal controlled diets']","['meal replacement (MR) with a low glycemic index (GI', 'ONCE PRO', 'MR', 'meal replacement therapy']","['Body weight (BW) and body mass index (BMI', 'metabolic outcomes', 'waist circumference, fasting plasma glucose, total cholesterol and triglycerides', 'HbA1c', 'metabolic profile', 'metabolic outcomes, HbA1c, total cholesterol and triglycerides', 'Low-density lipoprotein cholesterol (LDL-C', 'standard deviation in hemoglobin A1C (HbA1c']","[{'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0337910', 'cui_str': 'Thai'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0279033', 'cui_str': 'Replacement therapy'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C3853758', 'cui_str': 'Metabolic Profile'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}]",110.0,0.0864348,Patients consuming a MR instead of breakfast had a significant decrease in HbA1c ( p = 0.040).,"[{'ForeName': 'Apussanee', 'Initials': 'A', 'LastName': 'Boonyavarakul', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Phramongkutklao Hospital, Thailand.'}, {'ForeName': 'Rattana', 'Initials': 'R', 'LastName': 'Leelawattana', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Thailand.'}, {'ForeName': 'Chatlert', 'Initials': 'C', 'LastName': 'Pongchaiyakul', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Faculty of Medicine, Khonkaen University, Thailand.'}, {'ForeName': 'Supawan', 'Initials': 'S', 'LastName': 'Buranapin', 'Affiliation': 'Division of Endocrinology, Department of Internal medicine, Faculty of Medicine, Chiang Mai University, Thailand.'}, {'ForeName': 'Pariya', 'Initials': 'P', 'LastName': 'Phanachet', 'Affiliation': 'Division of Nutrition and Biochemical Medicine, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Thailand.'}, {'ForeName': 'Pornpoj', 'Initials': 'P', 'LastName': 'Pramyothin', 'Affiliation': 'Division of Nutrition, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Thailand.'}]",Nutrition and health,['10.1177/0260106018800074']
1430,30398407,"Decreased Thyroid Peroxidase Antibody Titer in Response to Selenium Supplementation in Autoimmune Thyroiditis and the Influence of a Selenoprotein P Gene Polymorphism: A Prospective, Multicenter Study in China.","Background:  Recent intervention studies have suggested that selenium (Se) is an effective treatment for autoimmune thyroiditis (AIT). However, the exact effect of Se on AIT is unclear as well as the mechanism of action. The aim of the present study was to explore the effect of Se on thyroid peroxidase antibody (TPOAb) titers in patients with AIT and to analyze the potential impact of the genetic background on the effect of Se supplementation.  Methods:  This was a randomized, placebo-controlled, double-blind trial. Three hundred and sixty-four patients with elevated TPOAb (>300 IU/mL) were recruited and randomized to receive Se yeast 200 μg/day supplementation or placebo. Urinary iodine concentration, serum thyrotropin, free thyroxine, TPOAb, Se, malondialdehyde, and serum glutathione peroxidase activity were measured at baseline and follow-up. Ninety-six patients were genotyped for single nucleotide polymorphism r25191G/A in the selenoprotein P ( SEPP1/SELENOP)  gene.  Results:  The median urinary iodine concentration was 182 μg/L. Serum Se increased significantly ( p  < 0.001) after Se treatment. TPOAb titer decreased by 10.0% at 3 months and by 10.7% at 6 months after Se supplementation, while there was a moderate increase in TPOAb titers over the follow-up period in patients receiving placebo. Glutathione peroxidase activity significantly increased ( p  < 0.001), and malondialdehyde significantly decreased ( p  < 0.001) after 6 months of Se supplementation. TPOAb titers decreased to variable extents in patients with different genotypes of single nucleotide polymorphism r25191G/A after Se supplementation. Serum TPOAb titers in patients with the AA genotype showed a more significant decrease (by 46.2%) than those with the GA and GG genotypes (by 14.5 and 9.8% respectively) at 3 months of Se supplementation ( p  = 0.070).  Conclusions:  Se supplementation significantly reduced TPOAb titers in patients with AIT, and there may be an important genetic component influencing interindividual differences in the decrease in TPOAb titers.",2018,TPOAb titer decreased to different extents in patients with different genotypes of SNP r25191g/a after Se supplementation.,"['SEPP Gene Polymorphism', '96 patients were genotyped for SNP r25191g/a', '364 patients with elevated TPOAb (>300 IU/mL', 'patients with AIT']","['placebo', 'Selenium Supplementation', 'Se yeast 200 μg/day supplementation or placebo']","['Urinary iodine concentration (UIC), serum thyroid-stimulating hormone (TSH), free thyroxine (FT4), TPOAb, Se, malondialdehyde (MDA), and serum glutathione peroxidase (GPX3) activity', 'thyroid peroxidase antibody', 'L. Serum Se', 'MDA', 'median UIC', 'Serum TPOAb titer', 'GPX3 activity', 'TPOAb titer']","[{'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0032529', 'cui_str': 'Polymorphism (Genetics)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439458', 'cui_str': 'international unit/milliliter'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0043393', 'cui_str': 'Yeasts'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0857986', 'cui_str': 'Serum thyroid stimulating hormone'}, {'cui': 'C0312452', 'cui_str': 'Free thyroxin (substance)'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0017822', 'cui_str': 'Glutathione:hydrogen-peroxide oxidoreductase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1318460', 'cui_str': 'Measurement of thyroperoxidase antibody (procedure)'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}]",364.0,0.131945,TPOAb titer decreased to different extents in patients with different genotypes of SNP r25191g/a after Se supplementation.,"[{'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'The Endocrine Institute and The Liaoning Provincial Key Laboratory of Endocrine Diseases, Department of Endocrinology and Metabolism, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Jinyuan', 'Initials': 'J', 'LastName': 'Mao', 'Affiliation': 'The Endocrine Institute and The Liaoning Provincial Key Laboratory of Endocrine Diseases, Department of Endocrinology and Metabolism, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Jiajun', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Endocrinology and Metabolism, ShanDong Provincial Hospital, JiNan, China.'}, {'ForeName': 'Juming', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': ""Department of Endocrinology and Metabolism, The General Hospital of the People's Liberation Army, Bejing, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yan', 'Affiliation': 'Department of Endocrinology and Metabolism, The Second Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Jianling', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Department of Endocrinology and Metabolism, The First Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': ""Department of Endocrinology and Metabolism, The General Hospital of the People's Liberation Army, Bejing, China.""}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Endocrinology and Metabolism, ShanDong Provincial Hospital, JiNan, China.'}, {'ForeName': 'Mingtong', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'Department of Endocrinology and Metabolism, The Second Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Bai', 'Affiliation': 'The Endocrine Institute and The Liaoning Provincial Key Laboratory of Endocrine Diseases, Department of Endocrinology and Metabolism, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'The Endocrine Institute and The Liaoning Provincial Key Laboratory of Endocrine Diseases, Department of Endocrinology and Metabolism, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Chenling', 'Initials': 'C', 'LastName': 'Fan', 'Affiliation': 'The Endocrine Institute and The Liaoning Provincial Key Laboratory of Endocrine Diseases, Department of Endocrinology and Metabolism, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'The Endocrine Institute and The Liaoning Provincial Key Laboratory of Endocrine Diseases, Department of Endocrinology and Metabolism, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Hongmei', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'The Endocrine Institute and The Liaoning Provincial Key Laboratory of Endocrine Diseases, Department of Endocrinology and Metabolism, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Zhongyan', 'Initials': 'Z', 'LastName': 'Shan', 'Affiliation': 'The Endocrine Institute and The Liaoning Provincial Key Laboratory of Endocrine Diseases, Department of Endocrinology and Metabolism, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Teng', 'Affiliation': 'The Endocrine Institute and The Liaoning Provincial Key Laboratory of Endocrine Diseases, Department of Endocrinology and Metabolism, The First Hospital of China Medical University, Shenyang, China.'}]",Thyroid : official journal of the American Thyroid Association,['10.1089/thy.2017.0230']
1431,30779417,Health behavior knowledge among Hispanic California islanders: Evaluation of a parental educational intervention.,"PURPOSE


To evaluate the impact of a school nurse-led pilot parent-focused education program for healthy eating and physical activity to reduce childhood obesity.
DESIGN AND METHODS


A quasi-experimental intervention design was used to assess the knowledge of 11 Hispanic mothers regarding healthy food choices and physical activity over a period of 1 year.
RESULTS


There was an improvement in parental knowledge domains. Children's body mass index (BMI) stabilized at the 1-year follow-up in the intervention group, while the BMI increased in the nonintervention group. Outcomes included improvement in parental health knowledge and children's BMI.
PRACTICE IMPLICATIONS


Pediatric and school nurses have a powerful role in preventive education. Knowledge gained by identifying the benefits of healthy food choices and physical activity for Hispanic mothers of obese children can be transformed into lifestyle changes for their children's weight control that begins in the home.",2019,"Children's body mass index (BMI) stabilized at the 1-year follow-up in the intervention group, while the BMI increased in the nonintervention group.","['Hispanic mothers of obese children', 'Pediatric and school nurses', '11 Hispanic mothers regarding healthy food choices and physical activity over a period of 1 year', 'Hispanic California islanders']",['school nurse-led pilot parent-focused education program'],"['parental knowledge domains', ""Children's body mass index (BMI) stabilized"", 'BMI', ""parental health knowledge and children's BMI""]","[{'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0302833', 'cui_str': 'School nurse (occupation)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0006754', 'cui_str': 'California'}]","[{'cui': 'C0302833', 'cui_str': 'School nurse (occupation)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",11.0,0.0209177,"Children's body mass index (BMI) stabilized at the 1-year follow-up in the intervention group, while the BMI increased in the nonintervention group.","[{'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Parsons', 'Affiliation': 'School of Nursing, California State University, Fullerton, California.'}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Rutkowski', 'Affiliation': 'School of Nursing, California State University, Fullerton, California.'}, {'ForeName': 'Ofir', 'Initials': 'O', 'LastName': 'Turel', 'Affiliation': 'Department of Information Systems and Decision Sciences, California State University, Fullerton, California.'}]",Journal for specialists in pediatric nursing : JSPN,['10.1111/jspn.12235']
1432,32408038,Does eccentric-concentric resistance training improve early functional outcomes compared to concentric resistance training after total knee arthroplasty?,"BACKGROUND


Total knee arthroplasty (TKA) is the preferred surgical treatment of end stage osteoarthritis of the knee. However, up to 20% of patients are dissatisfied after TKA. Moreover, kinesiophobia is negatively correlated with functional outcomes.
RESEARCH QUESTION


The aim of this study was to compare the effects of combined concentric-eccentric versus concentric program on muscular strength assessment and quality of life, after total knee arthroplasty in elderly people.
METHOD


A prospective study including 20 subjects (72.1 ± 6.3 years), following a rehabilitation program after TKA was performed. Subjects were randomized in combined eccentricconcentric (ECC-CON, n = 10) versus concentric (CN, n = 10) early rehabilitation protocols. There were no significant differences between groups with respect to demographic data. Data were collected before and after protocol: performance-based physical function (timed up and go test, 10-meter walk test, isokinetic assessment), Selfreported physical function and quality of life (Lequesne-ISK, WOMAC, OAKHQOL) and kinesiophobia assessment (TSK-CF). The Gaussian distribution for the whole population of this study was tested by a Kolmogorov-Smirnov test. Statistical analysis was performed using non-parametric Mann-Whitney U or Fisher's exact probability test, as appropriate.
RESULTS AND CONCLUSION


Performance-based physical function tests showed a significant improvement after early rehabilitation in the ECC-CON group for timed up and go (p = 0.0002) and 10-meter walk test (p = 0.001). Operated hamstring muscle peak torque was significantly improved in the ECC-CON group (p = 0.03). Self-reported physical function and quality of life tests were significantly better in the ECC-CON group for ISK (p = 0.03) and WOMAC (p = 0.04). Self-reported kinesiophobia significantly decreased after rehabilitation in both groups (p = 0.01) whilst there were no differences between groups. Early combined eccentric-concentric rehabilitation after TKA appears to be associated with improved outcomes compared to classic concentric rehabilitation protocols, on both physical function and quality of life. This information is new. Assessment and care of kinesiophobia should be considered in rehabilitation protocols standards.",2020,Self-reported physical function and quality of life tests were significantly better in the ECC-CON group for ISK (p = 0.03) and WOMAC (p = 0.04).,"['elderly people', '20 subjects (72.1\u202f±\u202f6.3 years), following a rehabilitation program after TKA was performed']","['combined concentric-eccentric versus concentric program', 'Total knee arthroplasty (TKA', 'concentric resistance training', 'eccentric-concentric resistance training', 'combined eccentricconcentric (ECC-CON, n\u202f=\u202f10) versus concentric (CN, n\u202f=\u202f10) early rehabilitation protocols', 'ECC-CON']","['Self-reported kinesiophobia', 'physical function and quality of life', 'Operated hamstring muscle peak torque', 'performance-based physical function (timed up and go test, 10-meter walk test, isokinetic assessment), Selfreported physical function and quality of life ', 'muscular strength assessment and quality of life', 'Self-reported physical function and quality of life tests']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C4077283', 'cui_str': '67Ga-ethylenecysteamine cysteine'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}]",20.0,0.023474,Self-reported physical function and quality of life tests were significantly better in the ECC-CON group for ISK (p = 0.03) and WOMAC (p = 0.04).,"[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Teissier', 'Affiliation': 'Université Paris, Laboratoire de Biologie Bioingénierie et Bioimagerie Ostéo-Articulaire (B3OA), UMR CNRS 7052, INSERM U1273, 10 Av de Verdun, 75010, Paris, France; Department of Orthopaedic Surgery, Hospital Cochin, APHP, Université Paris 5, Paris, France. Electronic address: vic.teissier@gmail.com.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Leclercq', 'Affiliation': ""Université d'Orléans, COST, 45100, Orléans, France. Electronic address: apa.olivet@orpea.net.""}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Schiano-Lomoriello', 'Affiliation': 'Université Orléans, CIAMS, 45067, Orléans, France; CIAMS, Université Paris-Sud, Université Paris-Saclay, 91405, Orsay Cedex, France. Electronic address: sandrine.schiano-lomoriello@univ-orleans.fr.'}, {'ForeName': 'Rémy', 'Initials': 'R', 'LastName': 'Nizard', 'Affiliation': 'Université Paris, Laboratoire de Biologie Bioingénierie et Bioimagerie Ostéo-Articulaire (B3OA), UMR CNRS 7052, INSERM U1273, 10 Av de Verdun, 75010, Paris, France; 6-AP-HP, Hôpital Lariboisière, Service de chirurgie orthopédique, F-75010, Paris, France. Electronic address: remy.nizard@aphp.fr.'}, {'ForeName': 'Hugues', 'Initials': 'H', 'LastName': 'Portier', 'Affiliation': ""Université Paris, Laboratoire de Biologie Bioingénierie et Bioimagerie Ostéo-Articulaire (B3OA), UMR CNRS 7052, INSERM U1273, 10 Av de Verdun, 75010, Paris, France; Université d'Orléans, COST, 45100, Orléans, France. Electronic address: hugues.portier@univ-orleans.fr.""}]",Gait & posture,['10.1016/j.gaitpost.2020.04.020']
1433,30520964,Cost-effectiveness analysis of medical management versus conservative surgery for early tubal pregnancy.,"STUDY QUESTION


Is conservative surgery (laparoscopic salpingotomy) cost-effective, using fertility as the endpoint compared with medical management (Methotrexate) in women with an early tubal pregnancy?
SUMMARY ANSWER


Conservative surgery appeared slightly, but not statistically significantly, more effective than medical management but also more costly.
WHAT IS KNOWN ALREADY


Women with an early tubal pregnancy treated with medical therapy (Methotrexate) or conservative surgery (laparoscopic salpingotomy) have comparable future intrauterine pregnancy rates by natural conception. Also, cost-minimisation studies have shown that medical therapy was less expensive than conservative surgery, but there is no cost-effectiveness study comparing these two treatments with fertility as the endpoint.
STUDY DESIGN, SIZE, DURATION


A multicentre randomised controlled trial-based (DEMETER study) cost-effectiveness analysis of conservative surgery compared with medical therapy in women with an early tubal pregnancy was performed.
PARTICIPANTS/MATERIALS, SETTINGS, METHODS


Included women had an ultrasound that confirmed an early tubal pregnancy. They were randomly allocated to conservative surgery or to medical therapy. The study clinical outcome was the intrauterine pregnancy rate. The payer's perspective was considered. Costs of conservative surgery and medical therapy were compared. The analysis was performed according to the intention-to-treat principle. Missing variables were imputed using the fully conditional method. To characterise uncertainty and to provide a summary of it, a non-parametric bootstrap resampling was executed and cost-effectiveness accessibility curves were constructed.
MAIN RESULTS AND THE ROLE OF CHANCE


At baseline, costs per woman in the conservative surgery group and in the medical therapy group were 2627€ and 2463€, respectively, with a statistically significant difference of +164€. Conservative surgery resulted in a marginally, but non-significant (P = 0.46), higher future intrauterine pregnancy rate compared to medical therapy (0.700 vs. 0.649); leading, after bootstrap, to an incremental cost-effectiveness ratio of 1299€ (95% CI = -29 252; +29 919). Acceptability curves showed that conservative surgery could be considered a cost-effective treatment at a threshold of 3201€ for one additional future intrauterine pregnancy.
LIMITATIONS, REASONS FOR CAUTION


A limitation was that monetary valuation was carried out using 2016 euros while the DEMETER study took place from 2005 to 2009. Anyway, the results would not have been very different given the marginal changes in the health insurance reimbursement tariffs during this period.
WIDER IMPLICATIONS OF THE FINDINGS


Conservative surgery can be considered a cost-effective treatment, if the additional cost of 3201€ per additional future intrauterine pregnancy is an acceptable financial effort for the payer.
STUDY FUNDING/COMPETING INTEREST(S)


None.
TRIAL REGISTRATION NUMBER


NCT 00137982.",2019,"Acceptability curves showed that conservative surgery could be considered a cost-effective treatment at a threshold of 3201€ for one additional future intrauterine pregnancy.
","['women with an early tubal pregnancy was performed', 'women with an early tubal pregnancy', 'early tubal pregnancy', 'Women with an early tubal pregnancy treated with']","['conservative surgery', 'medical therapy (Methotrexate) or conservative surgery (laparoscopic salpingotomy', 'conservative surgery (laparoscopic salpingotomy', 'medical management versus conservative surgery', 'medical management (Methotrexate', 'conservative surgery or to medical therapy', 'conservative surgery and medical therapy', 'medical therapy']","['intrauterine pregnancy rate', 'early tubal pregnancy']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032994', 'cui_str': 'Pregnancy, Tubal'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0843535', 'cui_str': 'Laparoscopic salpingotomy (procedure)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0149973', 'cui_str': 'Intrauterine pregnancy (finding)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032994', 'cui_str': 'Pregnancy, Tubal'}]",,0.120588,"Acceptability curves showed that conservative surgery could be considered a cost-effective treatment at a threshold of 3201€ for one additional future intrauterine pregnancy.
","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Bourel', 'Affiliation': 'INSERM, Université Paris-Saclay, Univ. Paris-Sud, UVSQ, Centre de Recherche en Epidémiologie et Santé des Populations, Hôpital Paul Brousse, 16 av Paul Vaillant Couturier, Villejuif, France.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Pelletier-Fleury', 'Affiliation': 'INSERM, Université Paris-Saclay, Univ. Paris-Sud, UVSQ, Centre de Recherche en Epidémiologie et Santé des Populations, Hôpital Paul Brousse, 16 av Paul Vaillant Couturier, Villejuif, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bouyer', 'Affiliation': 'INSERM, Université Paris-Saclay, Univ. Paris-Sud, UVSQ, Centre de Recherche en Epidémiologie et Santé des Populations, Hôpital Paul Brousse, 16 av Paul Vaillant Couturier, Villejuif, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Delbarre', 'Affiliation': 'INSERM, Université Paris-Saclay, Univ. Paris-Sud, UVSQ, Centre de Recherche en Epidémiologie et Santé des Populations, Hôpital Paul Brousse, 16 av Paul Vaillant Couturier, Villejuif, France.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Fernandez', 'Affiliation': 'INSERM, Université Paris-Saclay, Univ. Paris-Sud, UVSQ, Centre de Recherche en Epidémiologie et Santé des Populations, Hôpital Paul Brousse, 16 av Paul Vaillant Couturier, Villejuif, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Capmas', 'Affiliation': 'INSERM, Université Paris-Saclay, Univ. Paris-Sud, UVSQ, Centre de Recherche en Epidémiologie et Santé des Populations, Hôpital Paul Brousse, 16 av Paul Vaillant Couturier, Villejuif, France.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/dey352']
1434,30431527,The pressure-dependency of local measures of arterial stiffness.,"OBJECTIVE


To determine which ultrasound-based, single-point arterial stiffness estimate is least dependent on blood pressure (BP) to improve assessment of local vascular function.
METHODS


Ultrasound was used to assess blood flow and diameters at the left brachial artery of 20 healthy adults [55% female, 27.9 years (5.2), 24.2 (2.8) kg/m]. BP of both arms was measured simultaneously. Experimental (left) arm BP was then systematically manipulated by adjusting its position ABOVE (+30°) and BELOW (-30°) heart level in a randomized order following measurement at heart level (0°). The control (right) arm remained at heart level. Six stiffness measurements were calculated: compliance, distensibility, beta-stiffness, and three estimates of pulse wave velocity (PWV) (Bramwell Hill, blood flow, and beta-stiffness). We considered the measurement technique with the least significant change across positions to be the least pressure-dependent.
RESULTS


There was a large effect change in mean arterial pressure (np = 0.75, P < 0.001) in the experimental arm when it was ABOVE (Δ-4.4 mmHg) and BELOW (Δ10.4 mmHg) heart level. There was a main effect (P < 0.05) of arm position on all arterial stiffness measures. From least to most pressure-dependent, the arterial stiffness measurements were: PWV (blood flow method), compliance coefficient, beta-stiffness, distensibility coefficient, PWV (Bramwell-Hill method), and PWV (beta-stiffness index method).
CONCLUSION


All single-point measures assessed are pressure-dependent. The PWV (blood flow method) may be the least pressure-dependent single-point measure, and may be the most suitable single-point measure to assess local vascular function.",2019,"There was a large effect change in mean arterial pressure (np = 0.75, P < 0.001) in the experimental arm when it was ABOVE (Δ-4.4 mmHg) and BELOW (Δ10.4 mmHg) heart level.","['20 healthy adults [55% female, 27.9 years (5.2), 24.2 (2.8)\u200akg/m']",[],"['PWV (blood flow method), compliance coefficient, beta-stiffness, distensibility coefficient, PWV (Bramwell-Hill method), and PWV (beta-stiffness index method', 'compliance, distensibility, beta-stiffness, and three estimates of pulse wave velocity (PWV) (Bramwell Hill, blood flow, and beta-stiffness', 'blood flow and diameters', 'BP', 'pressure-dependency of local measures of arterial stiffness', 'blood pressure (BP', 'mean arterial pressure']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517790', 'cui_str': '5.2 (qualifier value)'}]",[],"[{'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0442532', 'cui_str': 'Hill (environment)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0011546', 'cui_str': 'Dependency'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}]",20.0,0.0200174,"There was a large effect change in mean arterial pressure (np = 0.75, P < 0.001) in the experimental arm when it was ABOVE (Δ-4.4 mmHg) and BELOW (Δ10.4 mmHg) heart level.","[{'ForeName': 'Gabriel H', 'Initials': 'GH', 'LastName': 'Zieff', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Heffernan', 'Affiliation': 'Department of Exercise Science, Syracuse University, Syracuse, New York, USA.'}, {'ForeName': 'Keeron', 'Initials': 'K', 'LastName': 'Stone', 'Affiliation': 'Department of Sport, Exercise, Health and Wellbeing, University of Gloucestershire, Gloucester, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Fryer', 'Affiliation': 'Department of Sport, Exercise, Health and Wellbeing, University of Gloucestershire, Gloucester, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Credeur', 'Affiliation': 'School of Human Performance & Recreation, University of Southern Mississippi, Hattiesburg, Mississippi, USA.'}, {'ForeName': 'Erik D', 'Initials': 'ED', 'LastName': 'Hanson', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Faulkner', 'Affiliation': 'Department of Sport & Exercise, University of Winchester, Winchester, UK.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Stoner', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}]",Journal of hypertension,['10.1097/HJH.0000000000001998']
1435,30672832,Effects of heart rate reduction with ivabradine on vascular stiffness and endothelial function in chronic stable coronary artery disease.,"INTRODUCTION


Epidemiological and clinical studies have shown a relevant association between heart rate and cardiovascular mortality. Experimental studies identified vascular effects of heart rate reduction with the If channel inhibitor ivabradine. Therefore, the effects of heart rate reduction on endothelial function and indices of arterial stiffness were examined in patients with stable coronary artery disease in a prospective, placebo-controlled clinical crossover study.
METHODS AND RESULTS


Twenty-three patients (18 men and 5 women) with a resting heart rate (HR) of at least 70 beats per minute (bpm) and stable coronary artery disease were enrolled in this study. In a cross-over design, all patients were treated with ivabradine (Iva, 7.5 mg b.i.d.) and placebo for 6 months each. Iva reduced heart rate by 11.4 bpm (Iva 58.8 ± 8.2 bpm vs. placebo 70.2 ± 8.3 bpm, P < 0.0001). Augmentation index (AIx75), carotid-femoral pulse wave velocity (cfPWV) and central aortic blood pressure were measured using applanation tonometry (SphygmoCor). HRR by Iva increased AIx75 by 12.4% (Iva 24.3 ± 10.5% vs. placebo 21.3 ± 10.1%, P < 0.05) and reduced cfPWV by 14.1% (Iva 6.3 ± 1.7 m/s vs. placebo 7.3 ± 1.4 m/s, P < 0.01). Iva increased mean central blood pressure by 7.8% (Iva 107.5 ± 15.4 mmHg vs. placebo 99.1 ± 12.2 mmHg, P < 0.001). Endothelial function was determined measuring the flow-mediated vasodilation (FMD) of the brachial artery. HRR by Iva increased FMD by 18.5% (Iva 7.3 ± 2.2% vs. placebo 6.0 ± 2.0%, P < 0.001). Aortic distensibility was characterized by MRI. HRR by Iva increased aortic distensibility by 33.3% (Iva 0.003 ± 0.001/mmHg vs. placebo 0.002 ± 0.010/mmHg, P < 0.01) and circumferential cyclic strain by 37.1% (Iva 0.062 ± 0.027 vs. placebo 0.039 ± 0.018, P < 0.0001).
CONCLUSION


Heart rate reduction with Iva increased endothelium-dependent vasodilation and reduced arterial stiffness in patients with stable CAD. These findings corroborate and expand the results collected in experimental studies and indicate the importance of heart rate as a determinant of vascular function.",2019,"Iva increased mean central blood pressure by 7.8% (Iva 107.5 ± 15.4 mmHg vs. placebo 99.1 ± 12.2 mmHg, P < 0.001).","['Twenty-three patients (18 men and 5 women) with a resting heart rate (HR) of at least 70 beats per minute (bpm) and stable coronary artery disease were enrolled in this study', 'chronic stable coronary artery disease', 'patients with stable coronary artery disease in a prospective, placebo-controlled clinical crossover study', 'patients with stable CAD']","['ivabradine', 'channel inhibitor ivabradine', 'placebo']","['HRR by Iva increased FMD', 'HRR', 'Augmentation index (AIx75), carotid-femoral pulse wave velocity (cfPWV) and central aortic blood pressure', 'heart rate', 'arterial stiffness', 'mean central blood pressure', 'Endothelial function', 'vascular stiffness and endothelial function', 'circumferential cyclic strain', 'endothelial function and indices of arterial stiffness', 'HRR by Iva increased aortic distensibility', 'reduced cfPWV', 'Aortic distensibility', 'heart rate and cardiovascular mortality']","[{'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate (observable entity)'}, {'cui': 'C0439385', 'cui_str': 'beats per minute'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C0257190', 'cui_str': 'ivabradine'}, {'cui': 'C0439799', 'cui_str': 'Channel (qualifier value)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0232148', 'cui_str': 'Femoral pulse, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0456180', 'cui_str': 'Aortic Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3178781', 'cui_str': 'Vascular Stiffness'}, {'cui': 'C0205113', 'cui_str': 'Circumferential (qualifier value)'}, {'cui': 'C0439596', 'cui_str': 'Cyclic (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.191248,"Iva increased mean central blood pressure by 7.8% (Iva 107.5 ± 15.4 mmHg vs. placebo 99.1 ± 12.2 mmHg, P < 0.001).","[{'ForeName': 'Anna Lena', 'Initials': 'AL', 'LastName': 'Hohneck', 'Affiliation': 'First Department of Medicine, University Medical Centre Mannheim (UMM), Faculty of Medicine Mannheim, University of Heidelberg and DZHK (German Center for Cardiovascular Research) Partner Site Heidelberg/Mannheim, Theodor-Kutzer-Ufer, Mannheim.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fries', 'Affiliation': 'Clinic for Diagnostic and Interventional Radiology, Saarland University Hospital, University of the Saarland.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Ströder', 'Affiliation': 'Clinic for Diagnostic and Interventional Radiology, Saarland University Hospital, University of the Saarland.'}, {'ForeName': 'Günther', 'Initials': 'G', 'LastName': 'Schneider', 'Affiliation': 'Clinic for Diagnostic and Interventional Radiology, Saarland University Hospital, University of the Saarland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Wagenpfeil', 'Affiliation': 'Institute for Medical Biometry, Epidemiology and Informatics (IMBEI), Saarland University, Campus Homburg.'}, {'ForeName': 'Stephan Henrik', 'Initials': 'SH', 'LastName': 'Schirmer', 'Affiliation': 'Department of Internal Medicine III, Saarland University Hospital, University of the Saarland, Kirrbergerstraße, Homburg/Saar.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Department of Internal Medicine III, Saarland University Hospital, University of the Saarland, Kirrbergerstraße, Homburg/Saar.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Laufs', 'Affiliation': 'Clinic and Polyclinic for Cardiology, University of Leipzig, Liebigstraße, Leipzig.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Custodis', 'Affiliation': 'Department of Internal Medicine III, Saarland University Hospital, University of the Saarland, Kirrbergerstraße, Homburg/Saar.'}]",Journal of hypertension,['10.1097/HJH.0000000000001984']
1436,31935716,High Incidence of New-Onset Joint Pain in Patients on Fluoroquinolones as Antituberculous Treatment.,"BACKGROUND


Joint pain is frequently observed in patients on antituberculous treatment, and pyrazinamide is known to be associated with joint pain in patients receiving antituberculous treatment. Fluoroquinolone-associated joint pain and tendon injury have been reported in long-term corticosteroid and transplant recipients, but data are lacking in patients with tuberculosis.
OBJECTIVES


The objective of this study was to examine the incidence of joint pain manifested during administration of antituberculous therapy and their association with fluoroquinolones.
METHODS


Patients diagnosed with tuberculosis attending the outpatient clinic over a period of 1 year were reviewed and divided into 3 groups: group A receiving pyrazinamide, group B receiving a fluoroquinolone, and group C receiving both pyrazinamide and a fluoroquinolone. Latency to onset of joint pain was noted in all 3 groups. Joint pain was initially managed with analgesics, and associated hyperuricemia was treated with allopurinol/febuxostat. Causative drugs were stopped in case of intolerable joint pain.
RESULTS


260 patients (47% females, aged 38 ± 18 years; mean ± SD) were included [group A (n = 140), group B (n = 81), and group C (n = 39)]. Overall, 76/260 (29%) patients developed joint pain: group A - 24/140 patients (17%), group B - 32/81 patients (40%), and group C - 20/39 patients (51%). The median latency to the onset of joint pain was 83 days (interquartile range, IQR 40-167): 55 days (IQR 32-66) in group A, 138 days (IQR 74-278) in group B, and 88 days (IQR 34-183) in group C. Hyperuricemia was present in 12/24 (50%) patients in group A and 11/20 (55%) patients in group C. Pyrazinamide was stopped in 7/140 (5%) patients in group A, fluoroquinolones in 6/81 (7%) patients in group B, and both pyrazinamide and fluoroquinolones were stopped in 5/39 (13%) patients in group C because of intolerable joint pain. Major joints affected were knees and ankles.
CONCLUSION


There is a high incidence of joint pain in patients receiving antituberculous treatment, which is higher when fluoroquinolones or the pyrazinamide-fluoroquinolone combination are administered as compared to pyrazinamide alone.",2020,"The median latency to the onset of joint pain was 83 days (interquartile range, IQR 40-167): 55 days (IQR 32-66) in group A, 138 days (IQR 74-278) in group B, and 88 days (IQR 34-183) in group C. Hyperuricemia was present in 12/24 (50%) patients in group A and 11/20 (55%) patients in group C. Pyrazinamide was stopped in 7/140 (5%) patients in group A, fluoroquinolones in 6/81 (7%) patients in group B, and both pyrazinamide and fluoroquinolones were stopped in 5/39 (13%) patients in group C because of intolerable joint pain.","['patients with tuberculosis', '260 patients (47% females, aged 38 ± 18 years; mean ± SD', 'Patients diagnosed with tuberculosis attending the outpatient clinic over a period of 1 year', 'patients receiving antituberculous treatment']","['allopurinol/febuxostat', 'pyrazinamide', 'Fluoroquinolone', 'fluoroquinolone, and group C receiving both pyrazinamide and a fluoroquinolone', 'fluoroquinolones']","['Latency to onset of joint pain', 'intolerable joint pain', 'Joint pain', 'High Incidence of New-Onset Joint Pain', 'median latency to the onset of joint pain', 'joint pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0002144', 'cui_str': 'Allopurinol'}, {'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0034239', 'cui_str': 'Pyrazinamide'}, {'cui': 'C0949665', 'cui_str': 'Fluoroquinolones'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}]","[{'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",260.0,0.0489038,"The median latency to the onset of joint pain was 83 days (interquartile range, IQR 40-167): 55 days (IQR 32-66) in group A, 138 days (IQR 74-278) in group B, and 88 days (IQR 34-183) in group C. Hyperuricemia was present in 12/24 (50%) patients in group A and 11/20 (55%) patients in group C. Pyrazinamide was stopped in 7/140 (5%) patients in group A, fluoroquinolones in 6/81 (7%) patients in group B, and both pyrazinamide and fluoroquinolones were stopped in 5/39 (13%) patients in group C because of intolerable joint pain.","[{'ForeName': 'Neha P', 'Initials': 'NP', 'LastName': 'Mandovra', 'Affiliation': 'Department of Respiratory Medicine, Fortis Hiranandani Hospital Vashi, Navi Mumbai, India.'}, {'ForeName': 'Tejashree T', 'Initials': 'TT', 'LastName': 'Lele', 'Affiliation': 'Department of Respiratory Medicine, Fortis Hiranandani Hospital Vashi, Navi Mumbai, India.'}, {'ForeName': 'Preyas J', 'Initials': 'PJ', 'LastName': 'Vaidya', 'Affiliation': 'Department of Respiratory Medicine, Fortis Hiranandani Hospital Vashi, Navi Mumbai, India.'}, {'ForeName': 'Vinod B', 'Initials': 'VB', 'LastName': 'Chavhan', 'Affiliation': 'Department of Respiratory Medicine, Fortis Hiranandani Hospital Vashi, Navi Mumbai, India.'}, {'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Leuppi-Taegtmeyer', 'Affiliation': 'Department of Clinical Pharmacology and Toxicology, University Hospital Basel and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Joerg D', 'Initials': 'JD', 'LastName': 'Leuppi', 'Affiliation': 'University Clinic of Medicine, Cantonal Hospital Baselland, Liestal, Switzerland.'}, {'ForeName': 'Prashant N', 'Initials': 'PN', 'LastName': 'Chhajed', 'Affiliation': 'Department of Respiratory Medicine, Fortis Hiranandani Hospital Vashi, Navi Mumbai, India, pchhajed@gmail.com.'}]",Respiration; international review of thoracic diseases,['10.1159/000505102']
1437,30395180,Simplifying the World Health Organization Protocol: 3 Steps Versus 6 Steps for Performance of Hand Hygiene in a Cluster-randomized Trial.,"BACKGROUND


In an experimental setting, a simplified, 3-step hand hygiene technique for applying alcohol-based hand rub was non inferior in terms of reduction of bacterial counts, as compared to the conventional World Health Organization 6-step technique. We therefore compared compliance and microbiological efficacy between both hand hygiene techniques in routine clinical practice.
METHODS


We performed a cluster-randomized trial from October-November 2015 at the University Hospital Basel, Switzerland: a tertiary, academic care center (ISRCTN45923734). We randomly assigned 12 wards to either the 3-step technique or the conventional 6-step technique of hand rubbing. The primary endpoints were compliance with the assigned technique and reduction of bacterial counts on the hands of health-care workers.
RESULTS


Overall, 2923 hand hygiene indications were observed, and compliance was 70.7% (2066/2923). Compliance with technique and indications was 51.7% (595/1151) and 75.9% (1151/1516) on wards assigned to the 3-step technique, respectively, as compared to 12.7% (116/915) and 65.0% (915/1407) on wards assigned to the 6-step technique (P < .001). The reduction factor (RF) of bacterial colony counts did not differ between techniques (median RF 0.97 log10 colony-forming units [CFU] [interquartile range 0.39-1.59] for the 3-step technique vs median RF 1.04 log10 CFU [interquartile range 0.49-1.52] for the 6-step technique; P = .629).
CONCLUSIONS


In a clinical setting, the simpler hand hygiene technique, consisting of 3 steps, resulted in higher compliance with both hand hygiene indications and technique, as compared to the 6 steps. As the results of the microbiological analyses exclude inferiority, the conventional 6 steps could be safely replaced by a simpler hand hygiene technique.
CLINICAL TRIALS REGISTRATION


ISRCTN45923734.",2019,"The reduction factor (RF) of bacterial colony counts did not differ between both techniques (median RF 0.97 log10 CFU, IQR 0.39-1.59 for the 3-step technique vs. median RF 1.04 log10 CFU, IQR 0.49-1.52 for the 6-step technique, p=0.629).
","['10/2015-11/2015 at the University Hospital Basel, Switzerland - a tertiary academic care center (ISRCTN45923734']",['3-step technique or the conventional 6-step technique for use of hand rub'],"['bacterial counts on hands of healthcare workers', 'reduction factor (RF) of bacterial colony counts']","[{'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]","[{'cui': 'C0004618', 'cui_str': 'Bacterial Count'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0368993', 'cui_str': 'Colony count'}]",12.0,0.0571497,"The reduction factor (RF) of bacterial colony counts did not differ between both techniques (median RF 0.97 log10 CFU, IQR 0.39-1.59 for the 3-step technique vs. median RF 1.04 log10 CFU, IQR 0.49-1.52 for the 6-step technique, p=0.629).
","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Tschudin-Sutter', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Sepulcri', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, Switzerland.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Dangel', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, Switzerland.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Ulrich', 'Affiliation': 'Department of Internal Medicine, University Hospital Basel, Switzerland.'}, {'ForeName': 'Reno', 'Initials': 'R', 'LastName': 'Frei', 'Affiliation': 'Division of Clinical Microbiology, University Hospital Basel, Switzerland.'}, {'ForeName': 'Andreas F', 'Initials': 'AF', 'LastName': 'Widmer', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, Switzerland.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy948']
1438,30392864,African-American Adolescents' Weight Loss Skills Utilization: Effects on Weight Change in a Sequential Multiple Assignment Randomized Trial.,"OBJECTIVE


Successful weight loss interventions for African-Americans adolescents are lacking. Cognitive-behavioral interventions seek to develop weight loss skills (e.g., counting calories, goal setting, managing one's environment). Little is known about how well adolescents implement such skills in their daily lives. Study aims were to (1) examine weight loss skills utilization at midpoint and end of a 6-month cognitive-behavioral/motivational interviewing weight loss sequential multiple assignment randomized trial (SMART), and (2) determine if greater skill utilization predicted weight loss at treatment end and 3 months post-treatment.
METHOD


One hundred and eighty six African-Americans adolescents with obesity and their caregiver were first randomly assigned to complete 3 months of cognitive-behavioral and motivational interviewing family-based weight loss treatment in their home or in the research office (Phase 1). Nonresponders (i.e., those who lost < 3% of initial weight, n = 161) were rerandomized to 3 months of continued skills training (n = 83) or contingency management (n = 78) for Phase 2; responders were allocated to 3 months of relapse prevention (n = 20). Adolescents' frequency of weight loss skills utilization was assessed via questionnaire at treatment midpoint and end.
RESULTS


Higher treatment attendance was associated with better skill utilization. Higher skill utilization was associated with more weight loss at treatment end, whereas higher baseline confidence was associated with more weight loss at follow-up.
CONCLUSIONS


This study indicates the importance of attending weight loss intervention sessions to develop and strengthen weight loss skills in African-American adolescents with obesity, and strengthening confidence to use such skills for continued weight loss.",2019,"Higher skill utilization was associated with more weight loss at treatment end, whereas higher baseline confidence was associated with more weight loss at follow-up.
","['One hundred and eighty six African-Americans adolescents with obesity and their caregiver', ""African-American Adolescents' Weight Loss Skills Utilization"", 'African-Americans adolescents', 'African-American adolescents with obesity']","['contingency management', 'cognitive-behavioral and motivational interviewing family-based weight loss treatment in their home or in the research office (Phase 1', 'continued skills training', 'Successful weight loss interventions']","['Higher skill utilization', 'skill utilization', 'weight loss', ""Adolescents' frequency of weight loss skills utilization""]","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0042153', 'cui_str': 'use'}]","[{'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0439559', 'cui_str': 'Phase 1 (qualifier value)'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",161.0,0.0348705,"Higher skill utilization was associated with more weight loss at treatment end, whereas higher baseline confidence was associated with more weight loss at follow-up.
","[{'ForeName': 'Angela J', 'Initials': 'AJ', 'LastName': 'Jacques-Tiura', 'Affiliation': 'Department of Family Medicine and Public Health Sciences, Wayne State University, Detroit, Michigan. Electronic address: angela.tiura@wayne.edu.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Ellis', 'Affiliation': 'Department of Family Medicine and Public Health Sciences, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Idalski Carcone', 'Affiliation': 'Department of Family Medicine and Public Health Sciences, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Naar', 'Affiliation': 'Department of Family Medicine and Public Health Sciences, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Brogan Hartlieb', 'Affiliation': 'Florida International University, Miami, Florida.'}, {'ForeName': 'Elizabeth K', 'Initials': 'EK', 'LastName': 'Towner', 'Affiliation': 'Department of Family Medicine and Public Health Sciences, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'N Templin', 'Affiliation': 'Department of Family Medicine and Public Health Sciences, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'K-L Catherine', 'Initials': 'KC', 'LastName': 'Jen', 'Affiliation': 'Department of Family Medicine and Public Health Sciences, Wayne State University, Detroit, Michigan.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2018.09.003']
1439,30502929,"Smokers' use of electronic cigarettes before, during, and in the month after hospitalization. Findings from the Helping HAND 2 Study.","INTRODUCTION


Hospitalization can motivate smokers to attempt cessation, and some smokers might use e-cigarettes to aid quitting after discharge. Little is known about the patterns and predictors of smokers' e-cigarette use immediately before, during, and after hospitalization.
METHODS


Secondary data analysis of a multi-site randomized controlled trial that enrolled 1357 hospitalized smokers planning to quit offered two intensities of post-discharge cessation treatment and reached 1100 participants at 1-month follow-up. We assessed reasons for and patterns of e-cigarette use before, during and immediately after hospitalization. Multivariable logistic regression models identified independent predictors of e-cigarette use.
RESULTS


E-cigarettes were used, primarily to aid quitting, by 21.4% of smokers in the month before admission, 3.1% during hospitalization, and 18.3% in the month after discharge. At 1 month, 10.6% were past 7-day (current) e-cigarette users, but few used e-cigarettes regularly and 57.3% also smoked tobacco. New e-cigarette use in the month after discharge was rare. The adjusted odds ratio (AOR;95%CI) for current e-cigarette use was higher among smokers who used e-cigarettes before hospitalization (5.08;3.31-7.81), consumed more alcohol (1.80;1.16-2.80) and had less confidence to quit (1.66;1.05-2.61). The AOR was lower among non-Hispanic blacks (0.25;0.09-0.71), Medicaid-insured (0.56;0.33-0.93), and those randomly assigned to receive free cessation medication and counseling at discharge (0.58;0.38-0.90).
CONCLUSIONS


Following hospitalization, some smokers who plan to quit use e-cigarettes, particularly if they used them before admission, are less confident to quit, or have less easy access to conventional treatment. Clinicians should document and be prepared to address e-cigarette use among hospitalized smokers.",2019,"The AOR was lower among non-Hispanic blacks (0.25;0.09-0.71), Medicaid-insured (0.56;0.33-0.93), and those randomly assigned to receive free cessation medication and counseling at discharge (0.58;0.38-0.90).
","['hospitalized smokers', '1357 hospitalized smokers planning to quit offered two intensities of post-discharge cessation treatment and reached 1100 participants at 1-month follow-up']",[],"['adjusted odds ratio (AOR;95%CI) for current e-cigarette use', 'AOR']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C4517537', 'cui_str': 'One thousand one hundred'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",[],"[{'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C4280017', 'cui_str': 'E-Cig Use'}]",1357.0,0.0215083,"The AOR was lower among non-Hispanic blacks (0.25;0.09-0.71), Medicaid-insured (0.56;0.33-0.93), and those randomly assigned to receive free cessation medication and counseling at discharge (0.58;0.38-0.90).
","[{'ForeName': 'Aleksandra A', 'Initials': 'AA', 'LastName': 'Herbeć', 'Affiliation': 'Tobacco Research and Treatment Center, Massachusetts General Hospital, Boston, MA, USA; Department of Behavioral Science and Health, University College London, London, UK. Electronic address: a.herbec@ucl.ac.uk.'}, {'ForeName': 'Yuchiao', 'Initials': 'Y', 'LastName': 'Chang', 'Affiliation': 'Tobacco Research and Treatment Center, Massachusetts General Hospital, Boston, MA, USA; Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Hilary A', 'Initials': 'HA', 'LastName': 'Tindle', 'Affiliation': 'Vanderbilt Center for Tobacco, Addiction, and Lifestyle (ViTAL), Division of General Internal Medicine and Public Health, Vanderbilt University Medical Center and Vanderbilt Medical School, Nashville, TN, USA; Geriatric Research Education and Clinical Centers (GRECC), Veterans Affairs Tennessee Valley Healthcare System, Nashville, TN, USA.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Rigotti', 'Affiliation': 'Tobacco Research and Treatment Center, Massachusetts General Hospital, Boston, MA, USA; Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}]",Addictive behaviors,['10.1016/j.addbeh.2018.10.039']
1440,32005992,Delayed iron improves iron status without altering malaria risk in severe malarial anemia.,"BACKGROUND


WHO guidelines recommend concurrent iron and antimalarial treatment in children with malaria and iron deficiency, but iron may not be well absorbed or utilized during a malaria episode.
OBJECTIVES


We aimed to determine whether starting iron 28 d after antimalarial treatment in children with severe malaria and iron deficiency would improve iron status and lower malaria risk.
METHODS


We conducted a randomized clinical trial on the effect of immediate compared with delayed iron treatment in Ugandan children 18 mo-5 y of age with 2 forms of severe malaria: cerebral malaria (CM; n = 79) or severe malarial anemia (SMA; n = 77). Asymptomatic community children (CC; n = 83) were enrolled as a comparison group. Children with iron deficiency, defined as zinc protoporphyrin (ZPP) ≥ 80 µmol/mol heme, were randomly assigned to receive a 3-mo course of daily oral ferrous sulfate (2 mg · kg-1 · d-1) either concurrently with antimalarial treatment (immediate arm) or 28 d after receiving antimalarial treatment (delayed arm). Children were followed for 12 mo.
RESULTS


All children with CM or SMA, and 35 (42.2%) CC, were iron-deficient and were randomly assigned to immediate or delayed iron treatment. Immediate compared with delayed iron had no effect in any of the 3 study groups on the primary study outcomes (hemoglobin concentration and prevalence of ZPP ≥ 80 µmol/mol heme at 6 mo, malaria incidence over 12 mo). However, after 12 mo, children with SMA in the delayed compared with the immediate arm had a lower prevalence of iron deficiency defined by ZPP (29.4% compared with 65.6%, P = 0.006), a lower mean concentration of soluble transferrin receptor (6.1 compared with 7.8 mg/L, P = 0.03), and showed a trend toward fewer episodes of severe malaria (incidence rate ratio: 0.39; 95% CI: 0.14, 1.12).
CONCLUSIONS


In children with SMA, delayed iron treatment did not increase hemoglobin concentration, but did improve long-term iron status over 12 mo without affecting malaria incidence.This trial was registered at clinicaltrials.gov as NCT01093989.",2020,"Immediate compared with delayed iron had no effect in any of the 3 study groups on the primary study outcomes (hemoglobin concentration and prevalence of ZPP ≥ 80 µmol/mol heme at 6 mo, malaria incidence over 12 mo).","['children with malaria and iron deficiency', 'Asymptomatic community children (CC; n\xa0=\xa083', 'All children with CM or SMA, and 35 (42.2%) CC, were iron-deficient', 'children with severe malaria and iron deficiency would improve iron status and lower malaria risk', 'Children with iron deficiency, defined as zinc protoporphyrin (ZPP) ≥ 80 µmol/mol heme', 'severe malarial anemia', 'Ugandan children 18 mo-5 y of age with 2 forms of severe malaria: cerebral malaria (CM; n\xa0=\xa079) or severe malarial anemia (SMA; n\xa0=\xa077']","['daily oral ferrous sulfate (2 mg · kg-1 · d-1) either concurrently with antimalarial treatment (immediate arm) or 28 d after receiving antimalarial treatment (delayed arm', 'delayed iron treatment']","['mean concentration of soluble transferrin receptor', 'hemoglobin concentration', 'episodes of severe malaria', 'prevalence of iron deficiency defined by ZPP', 'hemoglobin concentration and prevalence of ZPP\xa0≥\xa080 µmol/mol heme at 6 mo, malaria incidence']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0240066', 'cui_str': 'Iron deficiency (disorder)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0078791', 'cui_str': 'zinc protoporphyrin'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0018966', 'cui_str': 'Protoheme'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0241520', 'cui_str': 'Ugandans (ethnic group)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0024534', 'cui_str': 'Malaria, Cerebral'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0060282', 'cui_str': 'ferrous sulfate'}, {'cui': 'C0003374', 'cui_str': 'Antimalarial Agents'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1116139', 'cui_str': 'Transferrin receptor, soluble (substance)'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0240066', 'cui_str': 'Iron deficiency (disorder)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0018966', 'cui_str': 'Protoheme'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",83.0,0.421433,"Immediate compared with delayed iron had no effect in any of the 3 study groups on the primary study outcomes (hemoglobin concentration and prevalence of ZPP ≥ 80 µmol/mol heme at 6 mo, malaria incidence over 12 mo).","[{'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Cusick', 'Affiliation': 'Department of Pediatrics, University of Minnesota School of Medicine, Minneapolis, MN, USA.'}, {'ForeName': 'Robert O', 'Initials': 'RO', 'LastName': 'Opoka', 'Affiliation': 'Department of Paediatrics and Child Health, Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Ssemata', 'Affiliation': 'Department of Paediatrics and Child Health, Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Georgieff', 'Affiliation': 'Department of Pediatrics, University of Minnesota School of Medicine, Minneapolis, MN, USA.'}, {'ForeName': 'Chandy C', 'Initials': 'CC', 'LastName': 'John', 'Affiliation': 'Department of Pediatrics, University of Minnesota School of Medicine, Minneapolis, MN, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa004']
1441,30429078,Social cognitive group treatment for impaired insight in psychosis: A multicenter randomized controlled trial.,"PURPOSE


The majority of people with schizophrenia has impaired insight, which is related to a poorer outcome. In this study, we evaluate a new psychosocial intervention 'REFLEX' aimed at improving insight in people with schizophrenia. REFLEX focuses on targeting stigma-sensitivity, perspective taking and self-reflection in people with schizophrenia and low insight. Primary objective is to improve insight and subsequently to improve functional outcome and symptoms.
METHOD


A total of 121 people diagnosed with schizophrenia according to DSM IV criteria with impaired insight was included in 2012-2015 from seven sites in a multicenter randomized controlled trial. REFLEX was compared to an active control condition consisting of group-wise simplified cognitive remediation training. Primary outcome of the study were the preconditions of insight: internalized stigma, self-reflection, mental flexibility and perspective taking. Clinical insight and cognitive insight were secondary outcomes.
RESULTS


Although perspective taking, self-reflection, mental flexibility and stigma sensitivity remained unchanged after the intervention, results showed a significant improvement of clinical insight in both conditions directly after treatment (SAI-E Rater, p < .001, PANSS G12, p < .005) and at follow-up (SAI-E Rater, p < .01, SAI-E interview, p < .001, PANSS G12, p < .0001). Improvement of clinical insight directly after treatment was larger in the REFLEX condition (SAI-E Rater, p < .05). Other outcomes (self-esteem, quality of life and depression) remained unchanged.
CONCLUSION


Though insight improved in both conditions, REFLEX was not superior to simplified drill-and-practice cognitive remediation training. Nevertheless, this study indicates that structured interventions can significantly improve insight. Further research on the underlying mechanisms of both conditions is needed, as insight is unlikely to improve spontaneously in chronic patients.",2019,"Although perspective taking, self-reflection, mental flexibility and stigma sensitivity remained unchanged after the intervention, results showed a significant improvement of clinical insight in both conditions directly after treatment (SAI-E Rater, p ","['121 people diagnosed with schizophrenia according to DSM IV criteria with impaired insight was included in 2012-2015 from seven sites', 'psychosis', 'chronic patients', 'people with schizophrenia', 'people with schizophrenia and low insight']","['REFLEX', 'Social cognitive group treatment']","['functional outcome and symptoms', 'preconditions of insight: internalized stigma, self-reflection, mental flexibility and perspective taking', 'self-reflection, mental flexibility and stigma sensitivity', 'outcomes (self-esteem, quality of life and depression']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0233823', 'cui_str': 'Impaired insight (finding)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0233820', 'cui_str': 'Self-understanding'}]","[{'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1709632', 'cui_str': 'Precondition (attribute)'}, {'cui': 'C0233820', 'cui_str': 'Self-understanding'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0034380'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",121.0,0.0564751,"Although perspective taking, self-reflection, mental flexibility and stigma sensitivity remained unchanged after the intervention, results showed a significant improvement of clinical insight in both conditions directly after treatment (SAI-E Rater, p ","[{'ForeName': 'G H M', 'Initials': 'GHM', 'LastName': 'Pijnenborg', 'Affiliation': 'Dept. of Psychotic Disorders, GGZ-Drenthe, Dennenweg 9, 9404 LA Assen, the Netherlands; Dept. of Psychology, University of Groningen, Grote Kruisstraat 2/1, 9712 TS Groningen, the Netherlands. Electronic address: g.h.m.pijnenborg@rug.nl.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'de Vos', 'Affiliation': 'Dept. of Psychotic Disorders, GGZ-Drenthe, Dennenweg 9, 9404 LA Assen, the Netherlands.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Timmerman', 'Affiliation': 'Dept. of Psychology, University of Groningen, Grote Kruisstraat 2/1, 9712 TS Groningen, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Van der Gaag', 'Affiliation': 'Dept. of Clinical Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit, van der Boechorststraat 7, 1081 BT Amsterdam, the Netherlands; Dept. of Psychosis Research, Parnassia Psychiatric Institute, Zoutkeetsingel 40, 2512 HN The Hague, the Netherlands.'}, {'ForeName': 'B E', 'Initials': 'BE', 'LastName': 'Sportel', 'Affiliation': 'Dept. of Psychotic Disorders, GGZ-Drenthe, Dennenweg 9, 9404 LA Assen, the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Arends', 'Affiliation': 'Dept. of Psychotic Disorders, GGZ-Drenthe, Dennenweg 9, 9404 LA Assen, the Netherlands.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Koopmans', 'Affiliation': 'Department of Rehabilitation, Lentis Psychiatric Institute, Zuidlaren, the Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Van der Meer', 'Affiliation': 'Department of Rehabilitation, Lentis Psychiatric Institute, Zuidlaren, the Netherlands; Rob Giel Research Center, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Aleman', 'Affiliation': 'Dept. of Psychology, University of Groningen, Grote Kruisstraat 2/1, 9712 TS Groningen, the Netherlands; Neuroimaging Center, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}]",Schizophrenia research,['10.1016/j.schres.2018.10.018']
1442,29503145,Statin dose reduction with complementary diet therapy: A pilot study of personalized medicine.,"OBJECTIVE


Statin intolerance, whether real or perceived, is a growing issue in clinical practice. Our aim was to evaluate the effects of reduced-dose statin therapy complemented with nutraceuticals.
METHODS


First phase: Initially, 53 type 2 diabetic statin-treated patients received a supplementation with fish oil (1.7 g EPA + DHA/day), chocolate containing plant sterols (2.2 g/day), and green tea (two sachets/day) for 6 weeks. Second phase: ""Good responders"" to supplementation were identified after multivariate analysis (n = 10), and recruited for a pilot protocol of statin dose reduction. ""Good responders"" were then provided with supplementation for 12 weeks: standard statin therapy was kept during the first 6 weeks and reduced by 50% from weeks 6-12.
RESULTS


First phase: After 6 weeks of supplementation, plasma LDL-C (-13.7% ± 3.7, P = .002) and C-reactive protein (-35.5% ± 5.9, P = .03) were reduced. Analysis of lathosterol and campesterol in plasma suggested that intensity of LDL-C reduction was influenced by cholesterol absorption rate rather than its synthesis. Second phase: no difference was observed for plasma lipids, inflammation, cholesterol efflux capacity, or HDL particles after statin dose reduction when compared to standard therapy.
CONCLUSIONS


Although limited by the small sample size, our study demonstrates the potential for a new therapeutic approach combining lower statin dose and specific dietary compounds. Further studies should elucidate ""good responders"" profile as a tool for personalized medicine. This may be particularly helpful in the many patients with or at risk for CVD who cannot tolerate high dose statin therapy.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02732223.",2018,"Second phase: no difference was observed for plasma lipids, inflammation, cholesterol efflux capacity, or HDL particles after statin dose reduction when compared to standard therapy.
","['First phase', 'patients with or at risk for CVD who cannot tolerate high dose statin therapy', '53 type 2 diabetic statin-treated patients']","['Statin dose reduction with complementary diet therapy', 'supplementation with fish oil (1.7\xa0g EPA\xa0+\xa0DHA/day), chocolate containing plant sterols']","['C-reactive protein', 'plasma LDL-C', 'plasma lipids, inflammation, cholesterol efflux capacity, or HDL particles']","[{'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0012160', 'cui_str': 'nutritional management'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C4517512', 'cui_str': '1.7 (qualifier value)'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0008299', 'cui_str': 'Chocolate'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0031866', 'cui_str': 'Phytosterols'}]","[{'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipids'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}]",,0.0301848,"Second phase: no difference was observed for plasma lipids, inflammation, cholesterol efflux capacity, or HDL particles after statin dose reduction when compared to standard therapy.
","[{'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Scolaro', 'Affiliation': 'Department of Food and Experimental Nutrition, Faculty of Pharmaceutical Sciences, University of São Paulo, Av. Lineu Prestes, 580, B14 - 05508-900, São Paulo, Brazil.'}, {'ForeName': 'Marina S', 'Initials': 'MS', 'LastName': 'Nogueira', 'Affiliation': 'Department of Food and Experimental Nutrition, Faculty of Pharmaceutical Sciences, University of São Paulo, Av. Lineu Prestes, 580, B14 - 05508-900, São Paulo, Brazil.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Paiva', 'Affiliation': 'Department of Food and Experimental Nutrition, Faculty of Pharmaceutical Sciences, University of São Paulo, Av. Lineu Prestes, 580, B14 - 05508-900, São Paulo, Brazil.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Bertolami', 'Affiliation': 'Dyslipidemia Medical Section, Dante Pazzanese Institute of Cardiology, Av. Dr. Dante Pazzanese, 500, 04012-909, São Paulo, Brazil.'}, {'ForeName': 'Lucia P', 'Initials': 'LP', 'LastName': 'Barroso', 'Affiliation': 'Department of Statistics, Institute of Mathematics and Statistics, University of São Paulo, Rua do Matão, 1010, 05508-090, São Paulo, Brazil.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Vaisar', 'Affiliation': 'Department of Medicine, University of Washington School of Medicine, Seattle, WA 98195, USA.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Heffron', 'Affiliation': 'Leon H. Charney Division of Cardiology, Department of Medicine, New York University School of Medicine, New York, NY 10016, USA.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Fisher', 'Affiliation': 'Leon H. Charney Division of Cardiology, Department of Medicine, New York University School of Medicine, New York, NY 10016, USA.'}, {'ForeName': 'Inar A', 'Initials': 'IA', 'LastName': 'Castro', 'Affiliation': 'Department of Food and Experimental Nutrition, Faculty of Pharmaceutical Sciences, University of São Paulo, Av. Lineu Prestes, 580, B14 - 05508-900, São Paulo, Brazil. Electronic address: inar@usp.br.'}]",Molecular metabolism,['10.1016/j.molmet.2018.02.005']
1443,32408011,"Cold versus hot adenoidectomy: A prospective, randomized controlled trial.","OBJECTIVE


Adenoidectomy can be performed using the cold method (mainly adenoid curettes) or the hot method (suction diathermy). Both techniques have similar intra and postoperative outcomes. However, the long-term clinical outcome of improving sleep disorder symptoms has not been well established. The objective of this study was to compare outcomes of hot method and cold method adenoidectomy one year following the surgery.
STUDY DESIGN


A prospective, randomized, single-blinded study of children under age 16 years who underwent adenoidectomy during the years 2014-2017. Patients were randomized to hot or cold adenoidectomy techniques.
SETTING


A tertiary health care referral center.
SUBJECTS AND METHODS


The final analysis included 58 children, mean age 5.9 years (range 1.2-15). The primary outcome was change in the Pediatric Sleep Questionnaire (PSQ) scores one month and one year after surgery. The secondary outcome was complication rate.
RESULTS


Clinical and demographic parameters were similar between the patients in the hot method group (n = 30) and the cold method group (n = 28). Adenoid size and estimated bleeding were similar between the groups. At one month after surgery, PSQ score was improved by a mean + 0.31 in the hot method group compared to +0.32 in the cold method group (p = 0.54). Improvement in PSQ scores was greater following hot than cold adenoidectomy at one year after surgery (+0.31 points vs. +0.22 points, p = 0.009).
CONCLUSION


Hot adenoidectomy is associated with better outcome than the cold technique, as reflected by PSQ scores one year after the surgery.",2020,"At one month after surgery, PSQ score was improved by a mean + 0.31 in the hot method group compared to +0.32 in the cold method group (p = 0.54).","['A tertiary health care referral center', 'children under age 16 years who underwent adenoidectomy during the years 2014-2017', '58 children, mean age 5.9 years (range 1.2-15']","['hot method and cold method adenoidectomy', 'Cold versus hot adenoidectomy', 'cold adenoidectomy', 'Hot adenoidectomy', 'hot or cold adenoidectomy techniques']","['sleep disorder symptoms', 'Pediatric Sleep Questionnaire (PSQ) scores', 'complication rate', 'PSQ scores', 'PSQ score', 'Adenoid size and estimated bleeding']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001425', 'cui_str': 'Adenoid excision'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4068880', 'cui_str': '1.2'}]","[{'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0001425', 'cui_str': 'Adenoid excision'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0426463', 'cui_str': 'Adenoids size'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",58.0,0.101449,"At one month after surgery, PSQ score was improved by a mean + 0.31 in the hot method group compared to +0.32 in the cold method group (p = 0.54).","[{'ForeName': 'Shorook', 'Initials': 'S', 'LastName': ""Na'ara"", 'Affiliation': 'The Laboratory for Applied Cancer Research, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel; Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Waseem', 'Initials': 'W', 'LastName': 'Sayegh', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Nassar', 'Initials': 'N', 'LastName': 'Nassar', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Shinnawi', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Ziv', 'Initials': 'Z', 'LastName': 'Gil', 'Affiliation': 'The Laboratory for Applied Cancer Research, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel; Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Arie', 'Initials': 'A', 'LastName': 'Gordin', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel. Electronic address: a_gordin@rambam.health.gov.il.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110087']
1444,32408065,Spending the night next to a router - Results from the first human experimental study investigating the impact of Wi-Fi exposure on sleep.,"BACKGROUND


The use of wireless telecommunication systems such as wireless fidelity (Wi-Fi)-enabled devices has steadily increased in recent years. There are persistent concerns that radiofrequency electromagnetic field (RF-EMF) exposure might affect health. Possible effects of RF-EMF exposure on human sleep were examined with regard to mobile phones and base stations, but not with regard to Wi-Fi exposure.
OBJECTIVES


The present double-blind, sham-controlled, randomized, fully counterbalanced cross-over study addressed for the first time the question whether a whole night Wi-Fi exposure has an effect on sleep.
METHODS


Thirty-four healthy young male subjects (mean ± SD: 24.1 ± 2.9 years) spent five nights in the sleep laboratory. A screening and adaptation night was followed by two experimental nights. Each of the experimental nights was preceded by a baseline night. Sleep was evaluated at the subjective level by a questionnaire and at the objective level (macro- and microstructure) by polysomnography. Either 2.45 GHz Wi-Fi (max psSAR10g of 6.4 mW/kg) or sham signals were delivered by a newly developed head exposure facility.
RESULTS


Results showed no statistically significant acute effects of a whole-night Wi-Fi exposure on subjective sleep parameters as well as on parameters characterizing the macrostructure of sleep. Analyses of the microstructure of sleep revealed a reduction in global EEG power in the alpha frequency band (8.00-11.75 Hz) during NREM sleep under acute Wi-Fi exposure compared to sham.
DISCUSSION


The results of the present human experimental study are well in line with several other neurophysiological studies showing that acute RF-EMF exposure has no effect on the macrostructure of sleep. The slight physiological changes in EEG power observed under Wi-Fi exposure are neither reflected in the subjective assessment of sleep nor at the level of objective measurements. The present results are not indicative of a sleep disturbing effect of Wi-Fi exposure.",2020,"RESULTS


Results showed no statistically significant acute effects of a whole-night Wi-Fi exposure on subjective sleep parameters as well as on parameters characterizing the macrostructure of sleep.",['Thirty-four healthy young male subjects (mean\xa0±\xa0SD: 24.1\xa0±\xa02.9 years) spent five nights in the sleep laboratory'],"['GHz Wi-Fi', 'RF-EMF exposure', 'radiofrequency electromagnetic field (RF-EMF']","['subjective sleep parameters', 'global EEG power', 'Sleep']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517641', 'cui_str': '2.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0556961', 'cui_str': 'GHz'}, {'cui': 'C0013835', 'cui_str': 'Electromagnetic Fields'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]",34.0,0.0200575,"RESULTS


Results showed no statistically significant acute effects of a whole-night Wi-Fi exposure on subjective sleep parameters as well as on parameters characterizing the macrostructure of sleep.","[{'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Danker-Hopfe', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Competence Center for Sleep Medicine, Berlin, Germany. Electronic address: heidi.danker-hopfe@charite.de.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Bueno-Lopez', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Competence Center for Sleep Medicine, Berlin, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Dorn', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Competence Center for Sleep Medicine, Berlin, Germany.'}, {'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Schmid', 'Affiliation': 'Seibersdorf Laboratories, 2444, Seibersdorf, Austria.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Hirtl', 'Affiliation': 'Seibersdorf Laboratories, 2444, Seibersdorf, Austria.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Eggert', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Competence Center for Sleep Medicine, Berlin, Germany.'}]",International journal of hygiene and environmental health,['10.1016/j.ijheh.2020.113550']
1445,31648099,"Patritumab or placebo, with cetuximab plus platinum therapy in recurrent or metastatic squamous cell carcinoma of the head and neck: A randomised phase II study.","BACKGROUND


The fully human monoclonal antibody patritumab blocks HER3 activation, a resistance mechanism to cetuximab, induced by heregulin (HRG). A phase Ib study in recurrent and/or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) demonstrated tolerability and tumour response of patritumab + cetuximab + platinum.
METHODS


This was a randomised, double-blind, phase II study of patritumab + cetuximab with platinum-based therapy for first-line treatment of R/M SCCHN (Clinicaltrials.gov identifier: NCT02633800). Patients aged ≥18 years received patritumab or placebo, both combined with cetuximab + cisplatin or carboplatin. Co-primary end-points were progression-free survival (PFS) in the intent-to-treat (ITT) and the high-expression HRG (HRG high) populations.
RESULTS


Eighty-seven patients (n = 43 in the patritumab group; n = 44 in placebo group) enrolled. A median (range) of 6.5 (1-24) patritumab cycles were completed. Median PFS was similar between the patritumab group and placebo group in the ITT population (5.6 versus 5.5 months; hazard ratio [HR] 0.99 [95% confidence interval [CI], 0.6-1.7]; P = 0.96) and HRG-high subgroup (n = 51; 5.6 versus 5.6 months; HR 0.93 [95% CI, 0.5-1.8]; P = 0.82). Median overall survival in the ITT population was also similar (10.0 versus 12.7 months; HR 1.3 [95% CI, 0.69-2.29]; P = 0.46). All patients experienced ≥1 treatment-emergent adverse event (TEAE). Grade ≥III TEAEs were more frequent in the patritumab than the placebo group (84.1% versus 60.5%). The most common grade ≥III patritumab-related TEAE in the patritumab group (20.5% overall) was rash (6.8%).
CONCLUSION


Patritumab + cetuximab + platinum was tolerable but not superior to cetuximab + platinum.",2019,"Median overall survival in the ITT population was also similar (10.0 versus 12.7 months; HR 1.3 [95% CI, 0.69-2.29]; P = 0.46).","['recurrent or metastatic squamous cell carcinoma of the head and neck', 'recurrent and/or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN', '43 in the patritumab group; n\xa0=\xa044 in placebo group) enrolled', 'Eighty-seven patients (n\xa0', 'Patients aged ≥18 years received']","['cetuximab plus platinum therapy', 'placebo', 'patritumab or placebo, both combined with cetuximab\xa0+\xa0cisplatin or carboplatin', 'Patritumab\xa0', 'Patritumab or placebo', 'patritumab\xa0+\xa0cetuximab with platinum-based therapy', 'cetuximab\xa0+\xa0platinum']","['Grade ≥III', 'progression-free survival (PFS', '≥1 treatment-emergent adverse event (TEAE', 'Median overall survival', 'Median PFS']","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0334246', 'cui_str': 'Squamous cell carcinoma, metastatic (morphologic abnormality)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck (disorder)'}, {'cui': 'C3897976'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4517895', 'cui_str': 'Eighty-seven'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3897976'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",87.0,0.269585,"Median overall survival in the ITT population was also similar (10.0 versus 12.7 months; HR 1.3 [95% CI, 0.69-2.29]; P = 0.46).","[{'ForeName': 'Martin D', 'Initials': 'MD', 'LastName': 'Forster', 'Affiliation': 'Department of Oncology, UCL Cancer Institute/University College London Hospitals, London, UK.'}, {'ForeName': 'Magnus T', 'Initials': 'MT', 'LastName': 'Dillon', 'Affiliation': 'Head and Neck Unit, Royal Marsden Hospital/Institute of Cancer Research, National Institute of Health Research Biomedical Research Center, London, UK.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Kocsis', 'Affiliation': 'Oncology Department, Debrecen University Clinical Center, Debrecen, Hungary; Department of Oncoradiology, Bács-kiskun County Teaching Hospital (BKMK) Centre of Oncoradiology, Kecskemét, Hungary.'}, {'ForeName': 'Éva', 'Initials': 'É', 'LastName': 'Remenár', 'Affiliation': 'Hospitalier Order of Saint John of God Hospital Buda, Budapest, Hungary.'}, {'ForeName': 'Gabor', 'Initials': 'G', 'LastName': 'Pajkos', 'Affiliation': 'Department of Oncoradiology, Bács-kiskun County Teaching Hospital (BKMK) Centre of Oncoradiology, Kecskemét, Hungary.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Rolland', 'Affiliation': ""Department of Medical Oncology, Institut de Cancerologie de l'Ouest (ICO) - Site René Gauducheau, Saint-Herblain, France.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Greenberg', 'Affiliation': 'Research and Development Oncology, Daiichi Sankyo, Edison, NJ, USA.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Harrington', 'Affiliation': 'Head and Neck Unit, Royal Marsden Hospital/Institute of Cancer Research, National Institute of Health Research Biomedical Research Center, London, UK. Electronic address: Kevin.Harrington@icr.ac.uk.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.08.017']
1446,28012280,Whey and Casein Proteins and Medium-Chain Saturated Fatty Acids from Milk Do Not Increase Low-Grade Inflammation in Abdominally Obese Adults.,"BACKGROUND


Low-grade inflammation is involved in the development of diabetes and cardiovascular disease (CVD). Inflammation can be modulated by dietary factors. Dairy products are rich in saturated fatty acids (SFA), which are known to possess pro-inflammatory properties. However, different fatty acid compositions may exert different effects. Other components such as milk proteins may exert anti-inflammatory properties which may compensate for the potential negative effects of SFAs. Generally, the available data suggest a neutral role of dairy product consumption on inflammation.
AIM


To investigate the effects of, and potential interaction between, a dietary supplementation with whey protein and milk fat, naturally enriched in medium-chain SFA (MC-SFA), on inflammatory markers in abdominal obese adults.
METHODS


The study was a 12-week, randomized, double-blinded, intervention study. Sixty-three adults were equally allocated to one of four groups which received a supplement of either 60 g/day whey or 60 g/day casein plus 63 g/day milk fat either high or low in MC-SFA content. Fifty-two subjects completed the study. Before and after the intervention, changes in plasma interleukin-6 (IL-6), interleukin-1 receptor antagonist (IL-1RA), high-sensitive C-reactive protein (hsCRP), adiponectin, and monocyte chemoattractant protein-1 (MCP-1) were measured. Changes in inflammatory genes in the subcutaneous adipose tissue were also documented.
RESULTS


There were no differences in circulating inflammatory markers between protein types or fatty acid compositions in abdominally obese subjects, with the exception of an increase in adiponectin in response to high compared to low MC-SFA consumption in women. We found that combined dairy proteins and MC-SFAs influenced inflammatory gene expression in adipose tissue, while no effect was detected by dairy proteins or MC-SFA per se.
CONCLUSION


Whey protein compared with casein and MC-SFA-enriched milk fat did not alter circulating markers of low-grade inflammation in abdominally obese subjects, except for an increase in circulating adiponectin in response to high MC-SFA in abdominally obese women.",2016,"Before and after the intervention, changes in plasma interleukin-6 (IL-6), interleukin-1 receptor antagonist (IL-1RA), high-sensitive C-reactive protein (hsCRP), adiponectin, and monocyte chemoattractant protein-1","['Abdominally Obese Adults', 'abdominally obese subjects', 'Sixty-three adults', 'abdominally obese women', 'abdominal obese adults', 'Fifty-two subjects completed the study']","['dietary supplementation with whey protein and milk fat, naturally enriched in medium-chain SFA (MC-SFA', 'supplement of either 60 g/day whey or 60 g/day casein plus 63 g/day milk fat either high or low in MC-SFA content', 'Whey and Casein Proteins and Medium-Chain Saturated Fatty Acids from Milk', 'casein and MC-SFA-enriched milk fat']","['circulating inflammatory markers', 'plasma interleukin-6 (IL-6), interleukin-1 receptor antagonist (IL-1RA), high-sensitive C-reactive protein (hsCRP), adiponectin, and monocyte chemoattractant protein-1']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0439417', 'cui_str': 'g/day'}, {'cui': 'C0452720', 'cui_str': 'Whey'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0597423', 'cui_str': 'Fatty Acids, Saturated'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C2317059', 'cui_str': 'Interleukin 1 receptor antagonist product'}, {'cui': 'C1704264', 'cui_str': 'IL-1 Inhibitor, Urine'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0128897', 'cui_str': 'Chemokine (C-C Motif) Ligand 2'}]",63.0,0.136205,"Before and after the intervention, changes in plasma interleukin-6 (IL-6), interleukin-1 receptor antagonist (IL-1RA), high-sensitive C-reactive protein (hsCRP), adiponectin, and monocyte chemoattractant protein-1","[{'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Bohl', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Bjørnshave', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Gregersen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Kjeld', 'Initials': 'K', 'LastName': 'Hermansen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}]",The review of diabetic studies : RDS,[]
1447,31680011,Effectiveness of terlipressin for prevention of complications after major liver resection - A randomized placebo-controlled trial.,"BACKGROUND


Elevated portal pressure in response to major liver resection is associated with impaired liver regeneration and increased postoperative complications. Terlipressin, a splanchnic vasoconstrictor used for treatment of hepatorenal syndrome, was tested for reduction of complications and renal protection after liver resection.
METHODS


A randomized double-blinded placebo-controlled trial including patients undergoing elective major liver resection was performed. Terlipressin was administered to patients in the intervention group for five days. The primary outcome parameter was the incidence of a clinical composite endpoint of following liver specific complications 6 weeks after surgery: liver failure, ascites, bile leakage, intra-abdominal abscess and operative mortality. Postoperative kidney function was assessed as a secondary endpoint.
RESULTS


150 patients (mean age 63.4 years, 73.3% male) were included. No difference was found in the composite endpoint between the placebo and intervention group (32.8% versus 30.8%, relative risk 1.066, 95%CI 0.643 to 1.769, p = 0.85). Patients receiving terlipressin showed a significant lower decrease in postoperative estimated glomerular filtration rate compared to placebo (two way ANOVA, p = 0.005).
CONCLUSION


Perioperative administration of terlipressin during major liver surgery did not affect a composite endpoint of liver specific complications, but significantly protected from postoperative deterioration of kidney function compared to placebo. CLINICALTRIALS.
GOV IDENTIFIER


NCT01921985.",2020,"Patients receiving terlipressin showed a significant lower decrease in postoperative estimated glomerular filtration rate compared to placebo (two way ANOVA,","['complications after major liver resection - A randomized', '150 patients (mean age 63.4 years, 73.3% male) were included', 'patients undergoing elective major liver resection was performed']","['placebo', 'terlipressin', 'Terlipressin']","['postoperative estimated glomerular filtration rate', 'liver specific complications', 'incidence of a clinical composite endpoint of following liver specific complications 6 weeks after surgery: liver failure, ascites, bile leakage, intra-abdominal abscess and operative mortality', 'composite endpoint', 'Postoperative kidney function']","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0145185', 'cui_str': 'terlipressin'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3811844'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0085605', 'cui_str': 'Hepatic Failure'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C0005388', 'cui_str': 'Bile'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C0243001', 'cui_str': 'Abscess, Intra-Abdominal'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}]",150.0,0.728458,"Patients receiving terlipressin showed a significant lower decrease in postoperative estimated glomerular filtration rate compared to placebo (two way ANOVA,","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kohler', 'Affiliation': 'Department of Visceral Surgery and Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Perrodin', 'Affiliation': 'Department of Visceral Surgery and Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'De Gottardi', 'Affiliation': 'Department of Visceral Surgery and Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Candinas', 'Affiliation': 'Department of Visceral Surgery and Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Beldi', 'Affiliation': 'Department of Visceral Surgery and Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland. Electronic address: guido.beldi@insel.ch.'}]",HPB : the official journal of the International Hepato Pancreato Biliary Association,['10.1016/j.hpb.2019.10.011']
1448,31678060,Photobiomodulation as oedema adjuvant in post-orthognathic surgery patients: A randomized clinical trial.,"OBJECTIVE


Photobiomodulation therapy (PBMT) has been used in multiple applications in general medicine as powerful anti-inflammatory, analgesic and reducing oedema in different parts of the body. The aim of this study is to compare the effect on post-surgical oedema after mandibular orthognathic surgery, between two different laser power densities and oral medication with non-steroidal anti-inflammatory.
MATERIALS AND METHODS


In a randomized clinical trial, on 60 patients who were subject to mandibular orthognathic surgery were divided into three groups. All groups received sodium naproxen 250mg every 8hours for 6days. Two groups were irradiated with two different laser application protocols and the other was a control group. In G1 group the irradiation parameters three times per week for two weeks were: 940nm, in continuous mode, 2.5W, 120s, 85.71J/cm 2 , 0.89W/cm 2 , over the right and left side with a distance from the skin surface of 1mm with the whitening handpiece (spot size of 2.8cm 2 ). In G2, the irradiation parameters three times a week for two weeks were: 940nm, in continuous mode, 4.1W, 120s, 68.33J/cm 2 , 0.58W/cm 2  over the right and left side with a distance from the skin surface of 15mm, with the deep tissue handpiece (spot size of 7.1cm 2 ). In all the groups, millimetric facial measurements were taken from tragus to lateral commissure, and from lateral commissure to gonion in both sides.
RESULTS


All differences between T1 and T6 were significant for the three groups, (paired T, P<0.05). The differences between the groups were generally not significant (P>0.05) except for commissure - right and left gonion when compared G1 vs CG (P<0.05) and G2 vs CG (P<0.05). Initial changes (T1-T2) between groups were significantly different except for the measurement from commissure to right tragus G1 vs CG (P=0.411) and from commissure to left tragus G2 vs CG (P=0.94). The faster resolution of the oedema occurred in G2 group. PTBM with an energy density of 68.33J/cm 2  was the most effective adjuvant to oral medication with non-steroidal anti-inflammatory, to decrease post-surgical oedema after mandibular orthognathic surgery.",2020,The differences between the groups were generally not significant (P>0.05) except for commissure - right and left gonion when compared G1 vs CG (P<0.05) and G2 vs CG (P<0.05).,"['60 patients who were subject to mandibular orthognathic surgery', 'post-orthognathic surgery patients']","['sodium naproxen', 'Photobiomodulation', 'Photobiomodulation therapy (PBMT']","['faster resolution of the oedema', 'Initial changes (T1-T2']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0185624', 'cui_str': 'Orthognathic Surgery'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0027396', 'cui_str': 'Naproxen'}, {'cui': 'C4019433', 'cui_str': 'LLLT'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.022001,The differences between the groups were generally not significant (P>0.05) except for commissure - right and left gonion when compared G1 vs CG (P<0.05) and G2 vs CG (P<0.05).,"[{'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Domínguez Camacho', 'Affiliation': 'Universidad del Valle, Faculty of Dentistry, Department of Orthodontics, Cali, Colombia. Electronic address: angela.dominguezc@gmail.com.'}, {'ForeName': 'Sergio Andrés', 'Initials': 'SA', 'LastName': 'Velásquez', 'Affiliation': 'Department of Orthodontics Institución Universitaria Colegios de Colombia (UNICOC), Cali, Colombia.'}, {'ForeName': 'Neftalí Joaquín', 'Initials': 'NJ', 'LastName': 'Benjumea Marulanda', 'Affiliation': 'Universidad del Valle, Faculty of Dentistry, Department of Orthodontics, Cali, Colombia.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Moreno', 'Affiliation': 'Universidad del Valle, Faculty of Dentistry, Department of Orthodontics, Cali, Colombia.'}]",International orthodontics,['10.1016/j.ortho.2019.09.004']
1449,30653372,Occupational therapy and activity pacing with hospital-associated deconditioned older adults: a randomised controlled trial.,"Purpose:  To examine the efficacy of an occupational therapy activity pacing intervention with deconditioned older adults in rehabilitation. Method:  Randomised, single-blind controlled trial of deconditioned older adults admitted for rehabilitation following treatment of an acute medical condition, allocated to intervention [ n  = 51, males = 14, mean age = 80(8)] or control [ n  = 49, males = 12, mean age = 81(7)] group. The intervention group received individual and group activity pacing education with practice and application of techniques to daily activities and the home environment, while the control group received a typical occupational therapy program, which included brief activity pacing education. Outcomes included participation in daily living skills, health status (including pain and fatigue symptoms), self-efficacy in daily activities and activity pacing techniques using the Australian Therapy Outcome Measures-Occupational Therapy (AusTOMs-OT), Short Form-36 Health Survey (SF-36), Self-Efficacy Gauge and Activity Pacing Assessment. Results:  No differences in groups at admission. Comparison at discharge and three months post discharge using 2 × 2 mixed ANOVA demonstrated small differences in only one scale of the activity limitation domain of the AusTOMs-OT. No significant differences were found in other scales or domains of the AusTOMs-OT, nor secondary outcome measures. Conclusion:  Activity pacing in addition to typical occupational therapy during inpatient rehabilitation did not demonstrate benefits to participants in the management of their daily activities on returning home post hospitalisation.Implications for rehabilitationActivity pacing has been identified as one of the commonly used occupational therapy interventions utilised with deconditioned older adults in rehabilitation.An activity pacing intervention in conjunction with typical occupational therapy demonstrated no benefits for deconditioned older adults over typical occupational therapy which included basic education on this topic.Continuation of the activity pacing intervention into the outpatient setting may be of benefit to older adults and requires further investigation.",2020,An activity pacing intervention in conjunction with typical occupational therapy demonstrated no benefits for deconditioned older adults over typical occupational therapy which included basic education on this topic.,"['deconditioned older adults', 'with hospital-associated deconditioned older adults', 'deconditioned older adults admitted for rehabilitation following treatment of an acute medical condition, allocated to intervention [n\u2009=\u200951, males\u2009=\u200914, mean age\u2009=\u200980(8)] or control [n\u2009=\u200949, males\u2009=\u200912, mean age\u2009=\u200981(7)] group', 'older adults', 'deconditioned older adults in rehabilitation']","['rehabilitation Activity pacing', 'Occupational therapy and activity pacing', 'individual and group activity pacing education with practice and application of techniques to daily activities and the home environment, while the control group received a typical occupational therapy program, which included brief activity pacing education', 'Activity pacing', 'activity pacing intervention', 'occupational therapy activity pacing intervention']","['participation in daily living skills, health status (including pain and fatigue symptoms), self-efficacy in daily activities and activity pacing techniques using the Australian Therapy Outcome Measures-Occupational Therapy (AusTOMs-OT), Short Form-36 Health Survey (SF-36), Self-Efficacy Gauge and Activity Pacing Assessment']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}, {'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439053', 'cui_str': 'Fatigue - symptom (finding)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C2586282', 'cui_str': 'Therapy outcome measure'}, {'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0456564', 'cui_str': 'Gauges (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",,0.0149108,An activity pacing intervention in conjunction with typical occupational therapy demonstrated no benefits for deconditioned older adults over typical occupational therapy which included basic education on this topic.,"[{'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Timmer', 'Affiliation': 'School of Health Medical and Applied Sciences, Central Queensland University, Melbourne, Australia.'}, {'ForeName': 'Carolyn A', 'Initials': 'CA', 'LastName': 'Unsworth', 'Affiliation': 'School of Health Medical and Applied Sciences, Central Queensland University, Melbourne, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Browne', 'Affiliation': 'School of Health Medical and Applied Sciences, Central Queensland University, Melbourne, Australia.'}]",Disability and rehabilitation,['10.1080/09638288.2018.1535630']
1450,30169811,Can Intraindividual Variability in Cognitive Speed Be Reduced by Physical Exercise? Results From the LIFE Study.,"OBJECTIVES


Findings are mixed regarding the potential to improve older adults' cognitive ability via training and activity interventions. One novel sensitive outcome may be intraindividual variability (IIV) in cognitive speed, or moment-to-moment changes in a person's performance. The present article evaluated if participants who participated in a moderate physical activity intervention showed a reduction in IIV, compared with a successful aging education control group.
METHOD


For approximately 2.6 years, sedentary adults aged 70-90 years participated in the Lifestyle Interventions and Independence for Elders (LIFE) Study (n = 1,635), a multisite Phase 3 randomized controlled trial to reduce major mobility disability. They completed 4 reaction time tests at baseline and at approximately 24 months post-test.
RESULTS


Analyses were conducted following both the intent-to-treat principle and complier average casual effect modeling. Results indicated that participants in the physical activity group did not show a reduction in their IIV.
DISCUSSION


The lack of a significant reduction in IIV may be due to the mild nature of the physical activity program and the cognitively healthy sample. It is also possible that other types of lifestyle activity interventions (e.g., social and cognitive engagement) can elicit reductions in IIV for older adults.",2019,"Results indicated that participants in the physical activity group did not show a reduction in their IIV.
Discussion


The lack of a significant reduction in IIV may be due to the mild nature of the physical activity program and the cognitively healthy sample.","['For approximately 2.6 years, sedentary adults aged 70-90 years participated in the', 'participants who participated in a moderate physical activity intervention showed a reduction in IIV, compared to a successful aging education control group', 'older adults']",['Lifestyle Interventions and Independence for Elders (LIFE'],"['intraindividual variability (IIV) in cognitive speed, or moment-to-moment changes', 'major mobility disability']","[{'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C4517633', 'cui_str': 'Two point six'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",1635.0,0.0309241,"Results indicated that participants in the physical activity group did not show a reduction in their IIV.
Discussion


The lack of a significant reduction in IIV may be due to the mild nature of the physical activity program and the cognitively healthy sample.","[{'ForeName': 'Allison A M', 'Initials': 'AAM', 'LastName': 'Bielak', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, Fort Collins.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Brydges', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, Fort Collins.'}]","The journals of gerontology. Series B, Psychological sciences and social sciences",['10.1093/geronb/gby101']
1451,31562043,"Vinorelbine and continuous low-dose cyclophosphamide as maintenance chemotherapy in patients with high-risk rhabdomyosarcoma (RMS 2005): a multicentre, open-label, randomised, phase 3 trial.","BACKGROUND


For more than three decades, standard treatment for rhabdomyosarcoma in Europe has included 6 months of chemotherapy. The European paediatric Soft tissue sarcoma Study Group (EpSSG) aimed to investigate whether prolonging treatment with maintenance chemotherapy would improve survival in patients with high-risk rhabdomyosarcoma.
METHODS


RMS 2005 was a multicentre, open-label, randomised, controlled, phase 3 trial done at 102 hospitals in 14 countries. We included patients aged 6 months to 21 years with rhabdomyosarcoma who were considered to be at high risk of relapse: those with non-metastatic incompletely resected embryonal rhabdomyosarcoma occurring at unfavourable sites with unfavourable age (≥10 years) or tumour size (>5 cm), or both; those with any non-metastatic rhabdomyosarcoma with nodal involvement; and those with non-metastatic alveolar rhabdomyosarcoma but without nodal involvement. Patients in remission after standard treatment (nine cycles of ifosfamide, vincristine, dactinomycin with or without doxorubicin, and surgery or radiotherapy, or both) were randomly assigned (1:1) to stop treatment or continue maintenance chemotherapy (six cycles of intravenous vinorelbine 25 mg/m 2  on days 1, 8, and 15, and daily oral cyclophosphamide 25 mg/m 2 , on days 1-28). Randomisation was done by use of a web-based system and was stratified (block size of four) by enrolling country and risk subgroup. Neither investigators nor patients were masked to treatment allocation. The primary outcome was disease-free survival in the intention-to-treat population. Secondary outcomes were overall survival and toxicity. This trial is registered with EudraCT, number 2005-000217-35, and ClinicalTrials.gov, number NCT00339118, and follow-up is ongoing.
FINDINGS


Between April 20, 2006, and Dec 21, 2016, 371 patients were enrolled and randomly assigned to the two groups: 186 to stop treatment and 185 to receive maintenance chemotherapy. Median follow-up was 60·3 months (IQR 32·4-89·4). In the intention-to-treat population, 5-year disease-free survival was 77·6% (95% CI 70·6-83·2) with maintenance chemotherapy versus 69·8% (62·2-76·2) without maintenance chemotherapy (hazard ratio [HR] 0·68 [95% CI 0·45-1·02]; p=0·061), and 5-year overall survival was 86·5% (95% CI 80·2-90·9) with maintenance chemotherapy versus 73·7% (65·8-80·1) without (HR 0·52 [95% CI 0·32-0·86]; p=0·0097). Toxicity was manageable in patients who received maintenance chemotherapy: 136 (75%) of 181 patients had grade 3-4 leucopenia, 148 (82%) had grade 3-4 neutropenia, 19 (10%) had anaemia, two (1%) had thrombocytopenia, and 56 (31%) had an infection. One (1%) patient had a grade 4 non-haematological toxicity (neurotoxicity). Two treatment-related serious adverse events occurred: one case of inappropriate antidiuretic hormone secretion and one of a severe steppage gait with limb pain, both of which resolved.
INTERPRETATION


Adding maintenance chemotherapy seems to improve survival for patients with high-risk rhabdomyosarcoma. This approach will be the new standard of care for patients with high-risk rhabdomyosarcoma in future EpSSG trials.
FUNDING


Fondazione Città della Speranza, Association Léon Berard Enfant Cancéreux, Clinical Research Hospital Program (French Ministry of Health), and Cancer Research UK.",2019,"Toxicity was manageable in patients who received maintenance chemotherapy: 136 (75%) of 181 patients had grade 3-4 leucopenia, 148 (82%) had grade 3-4 neutropenia, 19 (10%) had anaemia, two (1%) had thrombocytopenia, and 56 (31%) had an infection.","['Between April 20, 2006, and Dec 21, 2016, 371 patients were enrolled and randomly assigned to the two groups: 186 to stop treatment and 185 to receive', '102 hospitals in 14 countries', 'patients with high-risk rhabdomyosarcoma in future EpSSG trials', 'patients with high-risk rhabdomyosarcoma', 'patients with high-risk rhabdomyosarcoma (RMS 2005', 'patients aged 6 months to 21 years with rhabdomyosarcoma who were considered to be at high risk of relapse: those with non-metastatic incompletely resected embryonal rhabdomyosarcoma occurring at unfavourable sites with unfavourable age (≥10 years) or tumour size (>5 cm), or both; those with any non-metastatic rhabdomyosarcoma with nodal involvement; and those with non-metastatic alveolar rhabdomyosarcoma but without nodal involvement']","['Vinorelbine and continuous low-dose cyclophosphamide', 'cyclophosphamide', 'ifosfamide, vincristine, dactinomycin with or without doxorubicin, and surgery or radiotherapy, or both) were randomly assigned (1:1) to stop treatment or continue maintenance chemotherapy (six cycles of intravenous vinorelbine', 'maintenance chemotherapy']","['grade 4 non-haematological toxicity (neurotoxicity', 'survival', 'thrombocytopenia', 'overall survival and toxicity', 'anaemia', '5-year disease-free survival', 'Toxicity', 'grade 3-4 leucopenia', '5-year overall survival', 'grade 3-4 neutropenia', 'inappropriate antidiuretic hormone secretion and one of a severe steppage gait with limb pain, both of which resolved', 'disease-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0035412', 'cui_str': 'Rhabdomyosarcoma'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0206656', 'cui_str': 'Embryonal Rhabdomyosarcoma'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0206655', 'cui_str': 'Rhabdomyosarcoma 2'}]","[{'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0020823', 'cui_str': 'Ifosfamide'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0010934', 'cui_str': 'Dactinomycin'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0481504', 'cui_str': 'Maintenance Chemotherapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0021141', 'cui_str': 'Syndrome of Inappropriate ADH (SIADH) Secretion'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0427149', 'cui_str': 'Gait, Drop Foot'}, {'cui': 'C0030196', 'cui_str': 'Pain in limb (finding)'}, {'cui': 'C3714811', 'cui_str': 'Resolved (qualifier value)'}]",371.0,0.370497,"Toxicity was manageable in patients who received maintenance chemotherapy: 136 (75%) of 181 patients had grade 3-4 leucopenia, 148 (82%) had grade 3-4 neutropenia, 19 (10%) had anaemia, two (1%) had thrombocytopenia, and 56 (31%) had an infection.","[{'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Bisogno', 'Affiliation': ""Haematology Oncology Division, Department of Women's and Children's Health, University of Padova, Padova, Italy. Electronic address: gianni.bisogno@unipd.it.""}, {'ForeName': 'Gian Luca', 'Initials': 'GL', 'LastName': 'De Salvo', 'Affiliation': 'Clinical Research Unit, Istituto Oncologico Veneto IOV-IRCCS, Padova, Italy.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Bergeron', 'Affiliation': ""Institut d'Hématologie et d'Oncologie Pédiatrique, Centre Léon Bérard, Lyon, France.""}, {'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'Gallego Melcón', 'Affiliation': ""Servicio de Oncología y Hematología Pediatrica, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Johannes H', 'Initials': 'JH', 'LastName': 'Merks', 'Affiliation': ""Princess Máxima Center for Paediatric Oncology, Utrecht, Netherlands; Department of Paediatric Oncology, Emma Children's Hospital-Academic Medical Center Amsterdam, Netherlands.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kelsey', 'Affiliation': ""Department of Paediatric Histopathology, Royal Manchester Children's Hospital, Manchester, UK.""}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Martelli', 'Affiliation': 'Department of Paediatric Surgery, Hôpital Bicêtre-Hôpitaux Universitaires Paris Sud, Assistance Publique-Hôpitaux de Paris, Le Kremlin Bicêtre, Paris, France.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Minard-Colin', 'Affiliation': 'Department of Paediatric and Adolescent Oncology, Gustave-Roussy, Villejuif, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Orbach', 'Affiliation': 'SIREDO Oncology Center, Institut Curie, PSL University, Paris, France.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Glosli', 'Affiliation': 'Department of Paediatric Research and Department of Paediatric and Adolescent Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Chisholm', 'Affiliation': 'Children and Young Peoples Unit, Royal Marsden Hospital, Sutton, Surrey, UK.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Casanova', 'Affiliation': 'Paediatric Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Zanetti', 'Affiliation': ""Haematology Oncology Division, Department of Women's and Children's Health, University of Padova, Padova, Italy.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Devalck', 'Affiliation': 'Paediatric Haematology and Oncology, Hôpital Universitaire des Enfants Reine Fabiola, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Ben-Arush', 'Affiliation': ""Joan and Sanford Weill Pediatric Hematology Oncology and Bone Marrow Transplantation Division, Ruth Rappaport Children's Hospital, Rambam Medical Center, Haifa, Israel.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Mudry', 'Affiliation': ""University Children's Hospital Brno, Czech Republic.""}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Ferman', 'Affiliation': 'Instituto Nacional de Câncer, Rio de Janeiro, Brazil.'}, {'ForeName': 'Meriel', 'Initials': 'M', 'LastName': 'Jenney', 'Affiliation': ""Department of Paediatric Oncology, Children's Hospital for Wales, Heath Park, Cardiff, UK.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ferrari', 'Affiliation': 'Paediatric Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30617-5']
1452,30617276,"Correction: Double-blind, placebo-controlled, dose-ranging trial of intravenous ketamine as adjunctive therapy in treatment-resistant depression (TRD).",Supplementary Figure 1 and Supplementary Tables 1-4 have been re-uploaded so as to reflect the versions supplied during proofs stage. The publisher apologizes for the error in versioning. The HTML version of the paper has been updated.,2020,The publisher apologizes for the error in versioning.,['treatment-resistant depression (TRD'],"['ketamine', 'placebo']",[],"[{'cui': 'C2063866', 'cui_str': 'Refractory Depression'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.237743,The publisher apologizes for the error in versioning.,"[{'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA. mfava@mgh.harvard.edu.'}, {'ForeName': 'Marlene P', 'Initials': 'MP', 'LastName': 'Freeman', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Flynn', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Judge', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Bettina B', 'Initials': 'BB', 'LastName': 'Hoeppner', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Cusin', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Dawn F', 'Initials': 'DF', 'LastName': 'Ionescu', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Sanjay J', 'Initials': 'SJ', 'LastName': 'Mathew', 'Affiliation': 'Baylor College of Medicine/Michael E. Debakey VA Medical Center, Houston, TX, USA.'}, {'ForeName': 'Lee C', 'Initials': 'LC', 'LastName': 'Chang', 'Affiliation': 'Baylor College of Medicine/Michael E. Debakey VA Medical Center, Houston, TX, USA.'}, {'ForeName': 'Dan V', 'Initials': 'DV', 'LastName': 'Iosifescu', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Murrough', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Debattista', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Alan F', 'Initials': 'AF', 'LastName': 'Schatzberg', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'University of Texas Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'University of Texas Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Sanacora', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'Samuel T', 'Initials': 'ST', 'LastName': 'Wilkinson', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'George I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}]",Molecular psychiatry,['10.1038/s41380-018-0311-2']
1453,32408610,Changes in Developmental Trajectories of Preschool Children with Autism Spectrum Disorder during Parental Based Intensive Intervention.,"(1) Background: Research highlights the positive effects of early intensive intervention with parent and school involvement for preschool children with Autism Spectrum Disorder (ASD) on general developmental outcomes and social skills in randomized controlled trials. However, given the inter-individual variability in the response to treatment, it is necessary to investigate intervention effects in terms of mediators and moderators in order to explain variability and to highlight mechanisms of change. (2) Methods: 25 children in the experimental group were exposed to early intensive intervention and 14 children in the control group were subjected to ""as usual"" intervention. The initial assessment was obtained at the time of diagnosis (T1) and the follow-up assessment was conducted after 15 months of intervention (T2) in both groups. (3) Results: Participants in the experimental group achieved more prominent gains in both cognitive and socio-interactive skills. The role of specific factors able to predict general quotient and language quotient after intervention were investigated, pointing out the contribution of personal-social and performance abilities. (4) Conclusions: The findings support the importance of parental involvement in targeting ASD core symptoms. Further, results informed our understanding of early predictors in order to identify specific elements to be targeted in the individualized intervention design.",2020,Participants in the experimental group achieved more prominent gains in both cognitive and socio-interactive skills.,"['preschool children with Autism Spectrum Disorder (ASD', 'Preschool Children with Autism']","['early intensive intervention and 14 children in the control group were subjected to ""as usual"" intervention']",['prominent gains in both cognitive and socio-interactive skills'],"[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205402', 'cui_str': 'Prominent'}]",25.0,0.02477,Participants in the experimental group achieved more prominent gains in both cognitive and socio-interactive skills.,"[{'ForeName': 'Arianna', 'Initials': 'A', 'LastName': 'Bentenuto', 'Affiliation': 'Department of Psychology and Cognitive Science, Laboratory of Observation, Diagnosis and Educational (ODFLAB), University of Trento, Rovereto, 38068 Trento, Italy.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Bertamini', 'Affiliation': 'Department of Psychology and Cognitive Science, Laboratory of Observation, Diagnosis and Educational (ODFLAB), University of Trento, Rovereto, 38068 Trento, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Perzolli', 'Affiliation': 'Department of Psychology and Cognitive Science, Laboratory of Observation, Diagnosis and Educational (ODFLAB), University of Trento, Rovereto, 38068 Trento, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Venuti', 'Affiliation': 'Department of Psychology and Cognitive Science, Laboratory of Observation, Diagnosis and Educational (ODFLAB), University of Trento, Rovereto, 38068 Trento, Italy.'}]",Brain sciences,['10.3390/brainsci10050289']
1454,31675088,Effect of a Community Agency-Administered Nurse Home Visitation Program on Program Use and Maternal and Infant Health Outcomes: A Randomized Clinical Trial.,"Importance


Postnatal home visitation to support parenting and infant healthy development is becoming increasingly common based on university efficacy studies, but effectiveness when disseminated by communities is not clear.
Objective


To test implementation and impact of the Family Connects (FC) program when administered by a community agency.
Design, Setting, and Participants


In this randomized clinical trial, births were randomly assigned to receive FC or treatment as usual. Independent evaluation was conducted through parent interviews and review of health and child protective services records. Interviewers were blind to the experimental condition of participants, and participants were blind about the purpose of the interview as an intervention evaluation. A total of 936 consecutive residential births at Duke University Hospital from January 1, 2014, through June 30, 2014, were included. Data were analyzed preliminarily for reporting to funders in early 2015 before all birth-record covariates were scored and were analyzed more comprehensively in mid-2019 after administrative birth and child protective service records became available.
Interventions


The goals of the FC brief universal program were to assess family-specific needs, complete brief interventions, and connect families with community resources. Community agencies and families were aligned through an electronic data system.
Main Outcomes and Measures


Case records documented program penetration and quality. The primary outcome was child protective services investigations for maltreatment. Secondary outcomes were the number of sustained community connections, maternal mental health, parenting behavior, infant well-child care visits and maternal postpartum care compliance, and emergency health care utilization.
Results


Of 936 births, 451 infants (48.2%) were female and 433 (46.3%) were from racial/ethnic minority groups. In all, 456 births (46.5%) were randomized to the intervention and 480 (53.5%) were randomized to the control. All analyses were based on intention to treat. The impact analysis included 158 intervention families and 158 control families. Intervention penetration was 76%, adherence to the protocol was 90%, and independent agreement in scoring (κ) was 0.75. Nurses identified and addressed minor problems for 52% of families and connected an additional 42% to community resources. Analysis of the primary outcome of child abuse investigations revealed a mean (SD) of 0.10 (0.30) investigations for the intervention group vs 0.18 (0.56) investigations for the control group (b = -0.09; 90% CI, -0.01 to -0.12; 95% CI, -0.18 to 0.01; P = .07). The intervention group's rate of possible maternal anxiety or depression was 18.2% vs 25.9% for the control group (b = -7.70; 90% CI, -15.2 to -0.1; 95% CI, -16.6 to 1.3; P = .09).
Conclusions and Relevance


This study indicates that a nurse home visitation program for families of newborns can be implemented by a community agency with high penetration and quality. Other communities could benefit from wider dissemination of the program provided that quality remains strong and evaluation continues.
Trial Registration


ClinicalTrials.gov identifier: NCT01843036.",2019,The intervention group's rate of possible maternal anxiety or depression was 18.2% vs 25.9% for the control group (,"['936 consecutive residential births at Duke University Hospital from January 1, 2014, through June 30, 2014, were included', '158 intervention families and 158 control families', '456 births (46.5%) were randomized to the intervention and 480 (53.5', '936 births, 451 infants (48.2%) were female and 433 (46.3%) were from racial/ethnic minority groups']","['FC', 'Community Agency-Administered Nurse Home Visitation Program', 'Family Connects (FC) program']","['Intervention penetration', 'number of sustained community connections, maternal mental health, parenting behavior, infant well-child care visits and maternal postpartum care compliance, and emergency health care utilization', 'rate of possible maternal anxiety or depression', 'Program Use and Maternal and Infant Health Outcomes', 'program penetration and quality', 'child protective services investigations for maltreatment']","[{'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0449379', 'cui_str': 'Connection (attribute)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0032782', 'cui_str': 'Postpartum Care'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205806', 'cui_str': 'Baby Health'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0681158', 'cui_str': 'Child Welfare Agencies'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",936.0,0.122137,The intervention group's rate of possible maternal anxiety or depression was 18.2% vs 25.9% for the control group (,"[{'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Dodge', 'Affiliation': 'Sanford School of Public Policy, Duke University, Durham, North Carolina.'}, {'ForeName': 'W Benjamin', 'Initials': 'WB', 'LastName': 'Goodman', 'Affiliation': 'Sanford School of Public Policy, Duke University, Durham, North Carolina.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Sanford School of Public Policy, Duke University, Durham, North Carolina.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': ""O'Donnell"", 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Murphy', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, North Carolina.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.14522']
1455,30623683,The effect of Tai Chi on balance and functional mobility in children with congenital sensorineural hearing loss.,"Background:  The aim of the study was to examine the effect of Tai Chi on balance and functional mobility in children with congenital sensorineural hearing loss. Methods:  The study included 39 children, aged 10-14 years, with congenital sensorineural hearing loss. The participants were divided into three groups as the Tai Chi group, conventional exercise group, and control group. The Tai Chi group and the conventional exercise group received a 1-h exercise program twice a week for 10 weeks. The balance function of the children was assessed using the Pediatric Balance Scale, the balance subtest of Bruininks-Oseretsky Test 2-Short Form, and the Functional Reach Test. The Timed Up and Go Test and the Timed Up and Down Stairs Test were used to assess functional mobility. The Wilcoxon rank, Kruskal-Wallis. and Mann-Whitney U-tests were used for statistical analyses. Results:  When the pre-training values of the groups were compared, with the exception of the Timed Up and Go test, there was no statistically significant difference with respect to demographic data, balance, and functional mobility parameters ( p  > 0.05). After training, the overall balance and functional mobility tests improved compared to pre-training values in both the Tai Chi and conventional exercise groups ( p  < 0.05). When the post-training values were compared between the groups, with the exception of the Functional Reach Test and the Timed Up and Down Stairs Test, the results of both exercise groups were superior to those of the control group ( p  < 0.05). Conclusions:  The results of this study indicate that Tai Chi and conventional exercise programs have positive effects on balance and functional mobility in children with congenital sensorineural hearing loss. However, no superiority of Tai Chi or the conventional exercise programs was determined over the other. Both Tai Chi and conventional exercise programs could be used to improve balance and functional mobility in children with congenital sensorineural hearing loss.Implications for rehabilitationTai Chi and conventional exercises are effective on balance in children with congenital sensorineural hearing loss.Tai Chi and conventional exercises are effective on functional mobility in children with congenital sensorineural hearing loss.Tai Chi may be added to the rehabilitation program for children with congenital sensorineural hearing loss.",2020,"After training, the overall balance and functional mobility tests improved compared to pre-training values in both the Tai Chi and conventional exercise groups (p < 0.05).","['children with congenital sensorineural hearing loss', '39 children, aged 10-14 years, with congenital sensorineural hearing loss']","['Tai Chi and conventional exercise programs', 'Tai Chi group, conventional exercise group, and control group', 'Tai Chi', 'conventional exercise group received a 1-h exercise program', 'rehabilitation Tai Chi and conventional exercises', 'Tai Chi and conventional exercises']","['balance and functional mobility', 'demographic data, balance, and functional mobility parameters', 'functional mobility', 'overall balance and functional mobility tests']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1865866', 'cui_str': 'Congenital sensorineural hearing loss (disorder)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",39.0,0.0178706,"After training, the overall balance and functional mobility tests improved compared to pre-training values in both the Tai Chi and conventional exercise groups (p < 0.05).","[{'ForeName': 'Sebahat Yaprak', 'Initials': 'SY', 'LastName': 'Cetin', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Health Sciences Faculty, Akdeniz University, Antalya, Turkey.'}, {'ForeName': 'Suat', 'Initials': 'S', 'LastName': 'Erel', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Pamukkale University, Denizli, Turkey.'}, {'ForeName': 'Ummuhan', 'Initials': 'U', 'LastName': 'Bas Aslan', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Pamukkale University, Denizli, Turkey.'}]",Disability and rehabilitation,['10.1080/09638288.2018.1535629']
1456,29195590,"Age differences in outcomes among patients in the ""Stimulant Abuser Groups to Engage in 12-Step"" (STAGE-12) intervention.","Emerging adults (roughly 18-29years) with substance use disorders can benefit from participation in twelve-step mutual-help organizations (TSMHO), however their attendance and participation in such groups is relatively low. Twelve-step facilitation therapies, such as the Stimulant Abuser Groups to Engage in 12-Step (STAGE-12), may increase attendance and involvement, and lead to decreased substance use.
AIMS


Analyses examined whether age moderated the STAGE-12 effects on substance use and TSMHO meeting attendance and participation.
DESIGN


We utilized data from a multisite randomized controlled trial, with assessments at baseline, mid-treatment (week 4), end-of-treatment (week 8), and 3- and 6- months post-randomization.
PARTICIPANTS


Participants were adults with DSM-IV diagnosed stimulant abuse or dependence (N=450) enrolling in 10 intensive outpatient substance use treatment programs across the U.S.
ANALYSIS


A zero-inflated negative binomial random-effects regression model was utilized to examine age-by-treatment interactions on substance use and meeting attendance and involvement.
FINDINGS


Younger age was associated with larger treatment effects for stimulant use. Specifically, younger age was associated with greater odds of remaining abstinent from stimulants in STAGE-12 versus Treatment-as-Usual; however, among those who were not abstinent during treatment, younger age was related to greater rates of stimulant use at follow-up for those in STAGE-12 compared to TAU. There was no main effect of age on stimulant use. Younger age was also related to somewhat greater active involvement in different types of TSMHO activities among those in STAGE-12 versus TAU. There were no age-by-treatment interactions for other types of substance use or for treatment attendance, however, in contrast to stimulant use; younger age was associated with lower odds of abstinence from non-stimulant drugs at follow-up, regardless of treatment condition. These results suggest that STAGE-12 can be beneficial for some emerging adults with stimulant use disorder, and ongoing assessment of continued use is of particular importance.",2018,"There were no age-by-treatment interactions for other types of substance use or for treatment attendance, however, in contrast to stimulant use; younger age was associated with lower odds of abstinence from non-stimulant drugs at follow-up, regardless of treatment condition.","['Emerging adults (roughly 18-29years) with substance use disorders', 'Participants were adults with DSM-IV diagnosed stimulant abuse or dependence (N=450) enrolling in 10 intensive outpatient substance use treatment programs across the U.S']",['STAGE-12'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C1456332', 'cui_str': 'Stimulant abuse'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0150359', 'cui_str': 'Substance use treatments and procedures'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}]",[],450.0,0.0236687,"There were no age-by-treatment interactions for other types of substance use or for treatment attendance, however, in contrast to stimulant use; younger age was associated with lower odds of abstinence from non-stimulant drugs at follow-up, regardless of treatment condition.","[{'ForeName': 'Sharon B', 'Initials': 'SB', 'LastName': 'Garrett', 'Affiliation': 'University of Washington Alcohol & Drug Abuse Institute, 1107 NE 45th Street, Suite 120, Seattle, WA 98105, United States. Electronic address: ghungus@uw.edu.'}, {'ForeName': 'Suzanne R', 'Initials': 'SR', 'LastName': 'Doyle', 'Affiliation': 'University of Washington Alcohol & Drug Abuse Institute, 1107 NE 45th Street, Suite 120, Seattle, WA 98105, United States.'}, {'ForeName': 'K Michelle', 'Initials': 'KM', 'LastName': 'Peavy', 'Affiliation': 'University of Washington Alcohol & Drug Abuse Institute, 1107 NE 45th Street, Suite 120, Seattle, WA 98105, United States; Evergreen Treatment Services, 1700 Airport Way South, Seattle, WA 98134, United States.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Wells', 'Affiliation': 'University of Washington Alcohol & Drug Abuse Institute, 1107 NE 45th Street, Suite 120, Seattle, WA 98105, United States.'}, {'ForeName': 'Mandy D', 'Initials': 'MD', 'LastName': 'Owens', 'Affiliation': 'Health Services Research & Development, VA Puget Sound Health Care System, 1660 S. Columbian Way, Seattle, WA 98118, United States.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Shores-Wilson', 'Affiliation': 'University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX 5390-9119, United States.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'DiCenzo', 'Affiliation': 'Zuckerberg San Francisco General Hospital, 1001 Potrero Ave Rm 1C12, San Francisco, CA 94110, United States.'}, {'ForeName': 'Dennis M', 'Initials': 'DM', 'LastName': 'Donovan', 'Affiliation': 'University of Washington Alcohol & Drug Abuse Institute, 1107 NE 45th Street, Suite 120, Seattle, WA 98105, United States.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2017.10.012']
1457,24700332,Internet-delivered treatment for substance abuse: a multisite randomized controlled trial.,"OBJECTIVE


Computer-delivered interventions have the potential to improve access to quality addiction treatment care. The objective of this study was to evaluate the effectiveness of the Therapeutic Education System (TES), an Internet-delivered behavioral intervention that includes motivational incentives, as a clinician-extender in the treatment of substance use disorders.
METHOD


Adult men and women (N=507) entering 10 outpatient addiction treatment programs were randomly assigned to receive 12 weeks of either treatment as usual (N=252) or treatment as usual plus TES, with the intervention substituting for about 2 hours of standard care per week (N=255). TES consists of 62 computerized interactive modules covering skills for achieving and maintaining abstinence, plus prize-based motivational incentives contingent on abstinence and treatment adherence. Treatment as usual consisted of individual and group counseling at the participating programs. The primary outcome measures were abstinence from drugs and heavy drinking (measured by twice-weekly urine drug screens and self-report) and time to dropout from treatment.
RESULTS


Compared with patients in the treatment-as-usual group, those in the TES group had a lower dropout rate (hazard ratio=0.72, 95% CI=0.57, 0.92) and a greater abstinence rate (odds ratio=1.62, 95% CI=1.12, 2.35). This effect was more pronounced among patients who had a positive urine drug or breath alcohol screen at study entry (N=228) (odds ratio=2.18, 95% CI=1.30, 3.68).
CONCLUSIONS


Internet-delivered interventions such as TES have the potential to expand access and improve addiction treatment outcomes. Additional research is needed to assess effectiveness in non-specialty clinical settings and to differentiate the effects of the community reinforcement approach and contingency management components of TES.",2014,"Compared with patients in the treatment-as-usual group, those in the TES group had a lower dropout rate (hazard ratio=0.72, 95% CI=0.57, 0.92) and a greater abstinence rate (odds ratio=1.62, 95% CI=1.12, 2.35).","['Adult men and women', 'substance abuse', 'N=507) entering 10 outpatient addiction treatment programs']","['Therapeutic Education System (TES', 'usual (N=252) or treatment as usual plus TES']","['dropout rate', 'abstinence rate', 'abstinence from drugs and heavy drinking (measured by twice-weekly urine drug screens and self-report) and time to dropout from treatment', 'positive urine drug or breath alcohol screen']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0740858', 'cui_str': 'Substance Abuse'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C0277982', 'cui_str': 'Smell of alcohol on breath (finding)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]",10.0,0.0998591,"Compared with patients in the treatment-as-usual group, those in the TES group had a lower dropout rate (hazard ratio=0.72, 95% CI=0.57, 0.92) and a greater abstinence rate (odds ratio=1.62, 95% CI=1.12, 2.35).","[{'ForeName': 'Aimee N C', 'Initials': 'AN', 'LastName': 'Campbell', 'Affiliation': ''}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': ''}, {'ForeName': 'Abigail G', 'Initials': 'AG', 'LastName': 'Matthews', 'Affiliation': ''}, {'ForeName': 'Maxine', 'Initials': 'M', 'LastName': 'Stitzer', 'Affiliation': ''}, {'ForeName': 'Gloria M', 'Initials': 'GM', 'LastName': 'Miele', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Polsky', 'Affiliation': ''}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Turrigiano', 'Affiliation': ''}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Walters', 'Affiliation': ''}, {'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'McClure', 'Affiliation': ''}, {'ForeName': 'Tiffany L', 'Initials': 'TL', 'LastName': 'Kyle', 'Affiliation': ''}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Wahle', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Van Veldhuisen', 'Affiliation': ''}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Goldman', 'Affiliation': ''}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Babcock', 'Affiliation': ''}, {'ForeName': 'Patricia Quinn', 'Initials': 'PQ', 'LastName': 'Stabile', 'Affiliation': ''}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': ''}, {'ForeName': 'Udi E', 'Initials': 'UE', 'LastName': 'Ghitza', 'Affiliation': ''}]",The American journal of psychiatry,['10.1176/appi.ajp.2014.13081055']
1458,31668592,"Levofloxacin prophylaxis in patients with newly diagnosed myeloma (TEAMM): a multicentre, double-blind, placebo-controlled, randomised, phase 3 trial.","BACKGROUND


Myeloma causes profound immunodeficiency and recurrent, serious infections. Around 5500 new cases of myeloma are diagnosed per year in the UK, and a quarter of patients will have a serious infection within 3 months of diagnosis. We aimed to assess whether patients newly diagnosed with myeloma benefit from antibiotic prophylaxis to prevent infection, and to investigate the effect on antibiotic-resistant organism carriage and health care-associated infections in patients with newly diagnosed myeloma.
METHODS


TEAMM was a prospective, multicentre, double-blind, placebo-controlled randomised trial in patients aged 21 years and older with newly diagnosed myeloma in 93 UK hospitals. All enrolled patients were within 14 days of starting active myeloma treatment. We randomly assigned patients (1:1) to levofloxacin or placebo with a computerised minimisation algorithm. Allocation was stratified by centre, estimated glomerular filtration rate, and intention to proceed to high-dose chemotherapy with autologous stem cell transplantation. All investigators, patients, laboratory, and trial co-ordination staff were masked to the treatment allocation. Patients were given 500 mg of levofloxacin (two 250 mg tablets), orally once daily for 12 weeks, or placebo tablets (two tablets, orally once daily for 12 weeks), with dose reduction according to estimated glomerular filtration rate every 4 weeks. Follow-up visits occurred every 4 weeks up to week 16, and at 1 year. The primary outcome was time to first febrile episode or death from all causes within the first 12 weeks of trial treatment. All randomised patients were included in an intention-to-treat analysis of the primary endpoint. This study is registered with the ISRCTN registry, number ISRCTN51731976, and the EU Clinical Trials Register, number 2011-000366-35.
FINDINGS


Between Aug 15, 2012, and April 29, 2016, we enrolled and randomly assigned 977 patients to receive levofloxacin prophylaxis (489 patients) or placebo (488 patients). Median follow-up was 12 months (IQR 8-13). 95 (19%) first febrile episodes or deaths occurred in 489 patients in the levofloxacin group versus 134 (27%) in 488 patients in the placebo group (hazard ratio 0·66, 95% CI 0·51-0·86; p=0·0018. 597 serious adverse events were reported up to 16 weeks from the start of trial treatment (308 [52%] of which were in the levofloxacin group and 289 [48%] of which were in the placebo group). Serious adverse events were similar between the two groups except for five episodes (1%) of mostly reversible tendonitis in the levofloxacin group.
INTERPRETATION


Addition of prophylactic levofloxacin to active myeloma treatment during the first 12 weeks of therapy significantly reduced febrile episodes and deaths compared with placebo without increasing health care-associated infections. These results suggest that prophylactic levofloxacin could be used for patients with newly diagnosed myeloma undergoing anti-myeloma therapy.
FUNDING


UK National Institute for Health Research.",2019,"Serious adverse events were similar between the two groups except for five episodes (1%) of mostly reversible tendonitis in the levofloxacin group.
","['patients with newly diagnosed myeloma undergoing anti-myeloma therapy', 'patients with newly diagnosed myeloma', 'patients aged 21 years and older with newly diagnosed myeloma in 93 UK hospitals', 'patients newly diagnosed with myeloma benefit from', '488 patients', 'patients with newly diagnosed myeloma (TEAMM', '489 patients) or', 'number 2011-000366-35.\nFINDINGS\n\n\nBetween Aug 15, 2012, and April 29, 2016, we enrolled and randomly assigned 977 patients to receive']","['levofloxacin prophylaxis', 'levofloxacin or placebo', 'levofloxacin', 'placebo tablets', 'placebo', 'prophylactic levofloxacin', 'chemotherapy with autologous stem cell transplantation', 'antibiotic prophylaxis', 'Levofloxacin prophylaxis']","['febrile episodes or deaths', '597 serious adverse events', 'time to first febrile episode or death', 'Serious adverse events', 'febrile episodes and deaths']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0282638', 'cui_str': 'Premedication, Antibiotic'}]","[{'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",977.0,0.742669,"Serious adverse events were similar between the two groups except for five episodes (1%) of mostly reversible tendonitis in the levofloxacin group.
","[{'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Drayson', 'Affiliation': 'School of Immunity and Infection, University of Birmingham, Birmingham, UK. Electronic address: m.t.drayson@bham.ac.uk.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Bowcock', 'Affiliation': ""King's College Hospital NHS Trust, London, UK.""}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Planche', 'Affiliation': ""Department of Medical Microbiology, St George's, University of London, London, UK.""}, {'ForeName': 'Gulnaz', 'Initials': 'G', 'LastName': 'Iqbal', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Pratt', 'Affiliation': 'University Hospitals Birmingham NHS Trust, Birmingham, UK.'}, {'ForeName': 'Kwee', 'Initials': 'K', 'LastName': 'Yong', 'Affiliation': 'Department of Haematology, UCL Cancer Institute, London, UK.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Wood', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Raynes', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Higgins', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Dawkins', 'Affiliation': 'Academic Unit of Health Economics, University of Leeds, Leeds, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Meads', 'Affiliation': 'Academic Unit of Health Economics, University of Leeds, Leeds, UK.'}, {'ForeName': 'Claire T', 'Initials': 'CT', 'LastName': 'Hulme', 'Affiliation': 'Academic Unit of Health Economics, University of Leeds, Leeds, UK.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Monahan', 'Affiliation': ""Department of Medical Microbiology, St George's, University of London, London, UK.""}, {'ForeName': 'Kamaraj', 'Initials': 'K', 'LastName': 'Karunanithi', 'Affiliation': 'University Hospitals North Midlands NHS Trust, Stoke On Trent, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Dignum', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Belsham', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Neilson', 'Affiliation': 'The Dudley Group NHS Foundation Trust, Russells Hall Hospital, Dudley, UK.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Harrison', 'Affiliation': 'University Hospitals Coventry and Warwickshire, Coventry, UK.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Lokare', 'Affiliation': 'University Hospitals Coventry and Warwickshire, Coventry, UK.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Campbell', 'Affiliation': 'East Suffolk and North Essex NHS Foundation Trust, Colchester, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hamblin', 'Affiliation': 'East Suffolk and North Essex NHS Foundation Trust, Colchester, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hawkey', 'Affiliation': 'West Midlands Public Health Laboratory, Heart of England NHS Trust, Birmingham, UK.'}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Whittaker', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Low', 'Affiliation': 'Patient Advocacy, Myeloma UK, Edinburgh UK.'}, {'ForeName': 'Janet A', 'Initials': 'JA', 'LastName': 'Dunn', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30506-6']
1459,32408644,Efficacy of the Rotary Instrument XP-Endo Finisher in the Removal of Calcium Hydroxide Intracanal Medicament in Combination with Different Irrigation Techniques: A Microtomographic Study.,"OBJECTIVES


This study aims to evaluate the efficacy of the rotary instrument XP-endo Finisher for the removal of Ca(OH) 2  aided by different irrigation regimens.
METHODS


Sixteen double-rooted upper premolar human teeth were selected for the study. Thirty-two canals were prepared using a ProTaper Next rotary system up to X3. Then, the canals were filled with Ca(OH) 2 . The volume of Ca(OH) 2  inside the canals was measured by microcomputed tomography (micro-CT). After that, the teeth were randomly allocated into two experimental groups, i.e., A and B (n = 16 canals). In group A, Ca(OH) 2  was removed using the master apical file (X3). In group B, Ca(OH) 2  was removed using a XP-endo finisher. In half of both groups (n = 8), syringe irrigation (SI) was used, while passive ultrasonic irrigation (PUI) was used for the other half. After removal, the remaining volume of Ca(OH) 2  was measured. All data were statistically analyzed using two-way ANOVA with Tukey's post hoc test.
RESULTS


The percentages of remaining Ca(OH) 2  in the apical thirds of all canals were significantly higher as compared with the middle and coronal thirds in all groups ( p  < 0.05). There was no significant difference between different files and techniques ( p  > 0.05).
CLINICAL SIGNIFICANCE


This study presents a new method for the removal of Ca(OH) 2  from root canals.",2020,The percentages of remaining Ca(OH) 2  in the apical thirds of all canals were significantly higher as compared with the middle and coronal thirds in all groups ( p  < 0.05).,['Sixteen double-rooted upper premolar human teeth were selected for the study'],"['syringe irrigation (SI', 'rotary instrument XP-endo Finisher', 'Calcium Hydroxide', 'Rotary Instrument XP-Endo Finisher']","['volume of Ca(OH', 'percentages of remaining Ca(OH']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",32.0,0.0135907,The percentages of remaining Ca(OH) 2  in the apical thirds of all canals were significantly higher as compared with the middle and coronal thirds in all groups ( p  < 0.05).,"[{'ForeName': 'Jameela', 'Initials': 'J', 'LastName': 'Denna', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, King Abdulaziz University, Jeddah 21589, Saudi Arabia.'}, {'ForeName': 'Lubna A', 'Initials': 'LA', 'LastName': 'Shafie', 'Affiliation': 'Faculty of Oral and Dental Medicine, Cairo University affiliated to Faculty of Dentistry, King Abdulaziz University, Jeddah 21589, Saudi Arabia.'}, {'ForeName': 'Loai', 'Initials': 'L', 'LastName': 'Alsofi', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, King Abdulaziz University, Jeddah 21589, Saudi Arabia.'}, {'ForeName': 'Mey', 'Initials': 'M', 'LastName': 'Al-Habib', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, King Abdulaziz University, Jeddah 21589, Saudi Arabia.'}, {'ForeName': 'Emad', 'Initials': 'E', 'LastName': 'AlShwaimi', 'Affiliation': 'Endodontic Division, Restorative Dental Sciences Department, College of Dentistry, Imam Abdulrahman Bin Faisal University, Dammam 31441, Saudi Arabia.'}]","Materials (Basel, Switzerland)",['10.3390/ma13102222']
1460,31664940,Association of platelet function with depression and its treatment with sertraline in patients with chronic kidney disease: analysis of a randomized trial.,"BACKGROUND


Major Depressive Disorder (MDD) can lead to adverse cardiovascular outcomes in patients with chronic kidney disease (CKD). Although one of the proposed mechanisms is heightened platelet activation, effects of MDD and its treatment with a selective serotonin reuptake inhibitor (SSRI) on platelet function in patients with CKD remain unclear.
METHODS


In a pre-specified analysis, changes from baseline to 12 weeks in whole blood platelet aggregation (WBPA) and plasma levels of E-selectin and P-selectin on treatment with sertraline vs. placebo were investigated in 175 patients with CKD (estimated glomerular filtration rate [eGFR] < 60 ml/min/1.73m 2 ) and MDD (MDD+/CKD+) in a randomized, double-blind trial. Correlations between severity of depressive symptoms and platelet function were also analyzed. In order to investigate whether differences in platelet function were due to presence of CKD or MDD, we compared a subgroup of 49 MDD+/CKD+ patients with eGFR < 30 ml/min/1.73m 2  to 43 non-depressed CKD controls (28 CKD with eGFR < 30 ml/min/1.73m 2  [MDD-/CKD+] and 15 individuals with eGFR ≥90 ml/min/1.73m 2  [MDD-/CKD-].
RESULTS


In MDD+/CKD+ individuals, there were no significant correlations between severity of depressive symptoms and platelet function, and no significant changes in platelet function after 12 weeks of treatment with sertraline vs. placebo. There were no significant differences in platelet function among MDD+/CKD+ patients and controls without MDD except in WBPA to 10 μM ADP (P = 0.03). WBPA to ADP was lower in the MDD-/CKD- group (8.0 Ω [5.0 Ω, 11.0 Ω]) as compared to the MDD-/CKD+ group (12.5 Ω [8.0 Ω, 14.5 Ω]), P = 0.01, and the MDD+/CKD+ group (11.0 Ω [8.0 Ω, 15.0 Ω]), P < 0.01.
CONCLUSIONS


Heightened ADP-induced platelet aggregability was observed in CKD patients compared to controls with normal kidney function, regardless of presence of comorbid MDD, and treatment with sertraline did not affect platelet function. These findings suggest that increased platelet activation may not be a major contributory underlying mechanism by which depression may lead to worse cardiovascular outcomes in patients with CKD. Future studies should include positive MDD controls without CKD to confirm our findings.
TRIAL REGISTRATION


ClinicalTrials.gov identifier numbers: CAST Study: NCT00946998 (Recruitment Status: Completed. First Posted: July 27, 2009. Results First Posted: January 30, 2018). WiCKDonASA Study: NCT01768637 (Recruitment Status: Completed. First Posted: January 15, 2013. Results First Posted: April 19, 2019).",2019,There were no significant differences in platelet function among MDD+/CKD+ patients and controls without MDD except in WBPA to 10 μM ADP (P = 0.03).,"['patients with chronic kidney disease (CKD', '15 individuals with eGFR ≥90', 'patients with chronic kidney disease', '175 patients with CKD', 'patients with CKD remain unclear', 'patients with CKD']","['WiCKDonASA', 'MDD-/CKD', 'serotonin reuptake inhibitor (SSRI', 'MDD+/CKD', 'sertraline', 'sertraline vs. placebo', 'MDD (MDD+/CKD']","['blood platelet aggregation (WBPA) and plasma levels of E-selectin', 'severity of depressive symptoms and platelet function', 'platelet aggregability', 'depressive symptoms and platelet function', 'WBPA to ADP', 'platelet function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4517605', 'cui_str': '175'}]","[{'cui': 'C0162758', 'cui_str': '5-HT Uptake Inhibitors'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0332621', 'cui_str': 'Aggregation (finding)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0115305', 'cui_str': 'LECAM-2'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1254881', 'cui_str': 'Platelet function'}, {'cui': 'C0001459', 'cui_str': ""Adenosine 5'-Pyrophosphate""}]",175.0,0.0493685,There were no significant differences in platelet function among MDD+/CKD+ patients and controls without MDD except in WBPA to 10 μM ADP (P = 0.03).,"[{'ForeName': 'Nishank', 'Initials': 'N', 'LastName': 'Jain', 'Affiliation': 'Department of Internal Medicine, University of Arkansas for Medical Sciences, 5323 Harry Hines Blvd, MC 8516, Dallas, TX, 75390, USA.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Wan', 'Affiliation': 'Department of Biostatistics, University of Arkansas for Medical Sciences, Little Rock, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Kothari', 'Affiliation': 'Department of Internal Medicine, University of Arkansas for Medical Sciences, 5323 Harry Hines Blvd, MC 8516, Dallas, TX, 75390, USA.'}, {'ForeName': 'Anuoluwapo', 'Initials': 'A', 'LastName': 'Adelodun', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, 5959 Harry Hines Blvd, MC 8516, Dallas, TX, 75390, USA.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Ware', 'Affiliation': 'Department of Physiology and Biophysics, University of Arkansas for Medical Sciences, Little Rock, USA.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Sarode', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, 5959 Harry Hines Blvd, MC 8516, Dallas, TX, 75390, USA.'}, {'ForeName': 'S Susan', 'Initials': 'SS', 'LastName': 'Hedayati', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, 5959 Harry Hines Blvd, MC 8516, Dallas, TX, 75390, USA. susan.hedayati@utsouthwestern.edu.'}]",BMC nephrology,['10.1186/s12882-019-1576-7']
1461,30629889,Feasibility and Acceptability of Metformin to Augment Low Milk Supply: A Pilot Randomized Controlled Trial.,"BACKGROUND


Metformin improves insulin action, but feasibility in treating low milk supply is unknown.
RESEARCH AIM


To determine the feasibility of a metformin- versus-placebo definitive randomized clinical trial in women with low milk production and signs of insulin resistance.
METHODS


Pilot trial criteria included: Mother 1-8 weeks postpartum (ideally 1-2 weeks), low milk production, and ≥1 insulin resistance sign; and singleton, healthy, term infant. Eligible mothers were randomly assigned 2:1 (metformin:placebo) and instructed in frequent milk removal for 28 days with option to stop at 14 days.
RESULTS


From 02/2015 through 06/2016, we screened 114 women, completed baseline assessments on 46, and trialed 15 (median, 36 days postpartum). Comparing metformin-assigned ( n = 10) to placebo ( n = 5), 70% versus 80% continued to day 28; peak median change in milk output was +8 versus -58 mL/24 hr ( p = .31) and 80% peaked at Day 14 for both groups; 0% versus 20% desired to continue assigned drug after study completion; 44% versus 0% reported nausea/vomiting. Post-hoc, median peak change in milk output was +22 (metformin completers, n = 8) versus -58 mL/24 hr (placebo + non-completers, n = 7, p = .07). At baseline assessment, median milk production was significantly lower in those with ( n = 31), versus those without ( n = 15) signs of insulin resistance ( p = .002).
CONCLUSIONS


Although results trend toward hypothesized direction, trial feasibility concerns include late enrollment and only 20% of metformin-assigned participants sustaining improved milk output to Day 28, with none perceiving metformin worthwhile. Better tools are needed to identify and treat metabolically-driven low milk production. Registered at ClinicalTrials.gov (NCT02179788) on 02/JUL/2014.",2019,"At baseline assessment, median milk production was significantly lower in those with ( n = 31), versus those without ( n = 15) signs of insulin resistance ( p = .002).
","['114 women, completed baseline assessments on 46, and trialed 15 (median, 36 days postpartum', 'Pilot trial criteria included: Mother 1-8 weeks postpartum (ideally 1-2 weeks), low milk production, and ≥1 insulin resistance sign; and singleton, healthy, term infant', 'women with low milk production and signs of insulin resistance', 'Eligible mothers']","['placebo', 'metformin', 'Metformin', 'metformin:placebo', 'metformin- versus-placebo']","['median peak change in milk output', 'nausea/vomiting', 'Feasibility and Acceptability', 'median milk production', 'insulin resistance', 'milk output', 'peak median change in milk output']","[{'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0033268'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0456128', 'cui_str': 'Term infant (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0033268'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}]",114.0,0.513601,"At baseline assessment, median milk production was significantly lower in those with ( n = 31), versus those without ( n = 15) signs of insulin resistance ( p = .002).
","[{'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Nommsen-Rivers', 'Affiliation': '1 University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Thompson', 'Affiliation': '1 University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Riddle', 'Affiliation': '1 University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ward', 'Affiliation': '1 University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Wagner', 'Affiliation': '1 University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'King', 'Affiliation': '1 University of Cincinnati, Cincinnati, OH, USA.'}]",Journal of human lactation : official journal of International Lactation Consultant Association,['10.1177/0890334418819465']
1462,29988125,Verapamil and beta cell function in adults with recent-onset type 1 diabetes.,"Pancreatic beta cell loss is a key factor in the pathogenesis of type 1 diabetes (T1D), but therapies to halt this process are lacking. We previously reported that the approved antihypertensive calcium-channel blocker verapamil, by decreasing the expression of thioredoxin-interacting protein, promotes the survival of insulin-producing beta cells and reverses diabetes in mouse models 1 . To translate these findings into humans, we conducted a randomized double-blind placebo-controlled phase 2 clinical trial ( NCT02372253 ) to assess the efficacy and safety of oral verapamil added for 12 months to a standard insulin regimen in adult subjects with recent-onset T1D. Verapamil treatment, compared with placebo was well tolerated and associated with an improved mixed-meal-stimulated C-peptide area under the curve, a measure of endogenous beta cell function, at 3 and 12 months (prespecified primary endpoint), as well as with a lower increase in insulin requirements, fewer hypoglycemic events and on-target glycemic control (secondary endpoints). Thus, addition of once-daily oral verapamil may be a safe and effective novel approach to promote endogenous beta cell function and reduce insulin requirements and hypoglycemic episodes in adult individuals with recent-onset T1D.",2018,"Pancreatic beta cell loss is a key factor in the pathogenesis of type 1 diabetes (T1D), but therapies to halt this process are lacking.","['adult subjects with recent-onset T1D', 'adults with recent-onset type 1 diabetes', 'adult individuals with recent-onset T1D']","['Verapamil', 'placebo', 'verapamil', 'oral verapamil', 'antihypertensive calcium-channel blocker verapamil', 'Verapamil treatment']","['insulin requirements, fewer hypoglycemic events and on-target glycemic control (secondary endpoints', 'efficacy and safety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0042523', 'cui_str': 'Verapamil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0006684', 'cui_str': 'Calcium Channel Blocking Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.123525,"Pancreatic beta cell loss is a key factor in the pathogenesis of type 1 diabetes (T1D), but therapies to halt this process are lacking.","[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Ovalle', 'Affiliation': 'Comprehensive Diabetes Center, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Grimes', 'Affiliation': 'Comprehensive Diabetes Center, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Guanlan', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Comprehensive Diabetes Center, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Anish J', 'Initials': 'AJ', 'LastName': 'Patel', 'Affiliation': 'Comprehensive Diabetes Center, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Truman B', 'Initials': 'TB', 'LastName': 'Grayson', 'Affiliation': 'Comprehensive Diabetes Center, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Lance A', 'Initials': 'LA', 'LastName': 'Thielen', 'Affiliation': 'Comprehensive Diabetes Center, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Anath', 'Initials': 'A', 'LastName': 'Shalev', 'Affiliation': 'Comprehensive Diabetes Center, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA. shalev@uab.edu.'}]",Nature medicine,['10.1038/s41591-018-0089-4']
1463,29282989,Using a therapeutic companion robot for dementia symptoms in long-term care: reflections from a cluster-RCT.,"OBJECTIVES


We undertook a cluster-randomised controlled trial exploring the effect of a therapeutic companion robot (PARO) compared to a look-alike plush toy and usual care on dementia symptoms of long-term care residents. Complementing the reported quantitative outcomes , this paper provides critical reflection and commentary on individual participant responses to PARO, observed through video recordings , with a view to informing clinical practice and research.
METHOD


A descriptive, qualitative design with five participants selected from the PARO intervention arm of the trial. The trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12614000508673).
RESULTS


The five participants and their responses to PARO are presented in terms of three issues: i.) Different pre-intervention clinical presentations and different responses; ii.) Same individual, different response - the need for continual assessment and review; and iii.) The ethics of giving and retrieving PARO. Implications for clinical practice and future research are discussed in relation to each issue.
CONCLUSION


The findings suggest that one approach does not fit all, and that there is considerable variation in responses to PARO. A number of recommendations are discussed to aid the delivery of psychosocial interventions with PARO in practice, as well as to guide future research.",2019,We undertook a cluster-randomised controlled trial exploring the effect of a therapeutic companion robot (PARO) compared to a look-alike plush toy and usual care on dementia symptoms of long-term care residents.,"['five participants selected from the PARO intervention arm of the trial', 'dementia symptoms of long-term care residents']","['therapeutic companion robot (PARO', 'look-alike plush toy and usual care', 'therapeutic companion robot']",[],"[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0023977'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0335343', 'cui_str': 'Companions'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C0040565', 'cui_str': 'Toys'}]",[],5.0,0.0373866,We undertook a cluster-randomised controlled trial exploring the effect of a therapeutic companion robot (PARO) compared to a look-alike plush toy and usual care on dementia symptoms of long-term care residents.,"[{'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Moyle', 'Affiliation': 'a Menzies Health Institute Queensland, Griffith University , Nathan, Brisbane , Queensland , Australia.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'a Menzies Health Institute Queensland, Griffith University , Nathan, Brisbane , Queensland , Australia.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Murfield', 'Affiliation': 'a Menzies Health Institute Queensland, Griffith University , Nathan, Brisbane , Queensland , Australia.'}, {'ForeName': 'Lukman', 'Initials': 'L', 'LastName': 'Thalib', 'Affiliation': 'c Department of Public Health, College of Health Sciences , Qatar University , Qatar.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Beattie', 'Affiliation': 'd School of Nursing , Queensland University of Technology , Kelvin Grove, Brisbane , Queensland , Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shum', 'Affiliation': 'a Menzies Health Institute Queensland, Griffith University , Nathan, Brisbane , Queensland , Australia.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Draper', 'Affiliation': 'g School of Psychiatry, University of New South Wales , Sydney , Australia.'}]",Aging & mental health,['10.1080/13607863.2017.1421617']
1464,30606271,Modulation of anterior cingulate cortex reward and penalty signalling in medication-naive young-adult subjects with depressive symptoms following acute dose lurasidone.,"BACKGROUND


Aberrations in reward and penalty processing are implicated in depression and putatively reflect altered dopamine signalling. This study exploits the advantages of a placebo-controlled design to examine how a novel D2 antagonist with adjunctive antidepressant properties modifies activity in the brain's reward network in depression.
METHODS


We recruited 43 medication-naïve subjects across the range of depression severity (Beck's Depression Inventory-II score range: 0-43), including healthy volunteers, as well as people meeting full-criteria for major depressive disorder. In a double-blind placebo-controlled cross-over design, all subjects received either placebo or lurasidone (20 mg) across two visits separated by 1 week. Functional magnetic resonance imaging with the Monetary Incentive Delay (MID) task assessed reward functions via neural responses during anticipation and receipt of gains and losses. Arterial spin labelling measured cerebral blood flow (CBF) at rest.
RESULTS


Lurasidone altered fronto-striatal activity during anticipation and outcome phases of the MID task. A significant three-way Medication-by-Depression severity-by-Outcome interaction emerged in the anterior cingulate cortex (ACC) after correction for multiple comparisons. Follow-up analyses revealed significantly higher ACC activation to losses in high- v. low depression participants in the placebo condition, with a normalisation by lurasidone. This effect could not be accounted for by shifts in resting CBF.
CONCLUSIONS


Lurasidone acutely normalises reward processing signals in individuals with depressive symptoms. Lurasidone's antidepressant effects may arise from reducing responses to penalty outcomes in individuals with depressive symptoms.",2019,"Follow-up analyses revealed significantly higher ACC activation to losses in high- v. low depression participants in the placebo condition, with a normalisation by lurasidone.","[""43 medication-naïve subjects across the range of depression severity (Beck's Depression Inventory-II score range: 0-43), including healthy volunteers, as well as people meeting full-criteria for major depressive disorder"", 'individuals with depressive symptoms', 'medication-naive young-adult subjects with depressive symptoms following acute dose lurasidone']","['placebo or lurasidone', 'Functional magnetic resonance imaging with the Monetary Incentive Delay (MID) task assessed reward functions', 'placebo']","['Lurasidone altered fronto-striatal activity', 'ACC activation to losses', 'Arterial spin labelling measured cerebral blood flow (CBF']","[{'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C4273555', 'cui_str': 'BDI-II (Beck Depression Inventory Second Edition) score'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C2003424', 'cui_str': 'lurasidone'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2003424', 'cui_str': 'lurasidone'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0031843', 'cui_str': 'function'}]","[{'cui': 'C2003424', 'cui_str': 'lurasidone'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}]",,0.285157,"Follow-up analyses revealed significantly higher ACC activation to losses in high- v. low depression participants in the placebo condition, with a normalisation by lurasidone.","[{'ForeName': 'Selina A', 'Initials': 'SA', 'LastName': 'Wolke', 'Affiliation': ""Department of Child and Adolescent Psychiatry,Institute of Psychiatry, Psychology, and Neuroscience, King's College London,London,UK.""}, {'ForeName': 'Mitul A', 'Initials': 'MA', 'LastName': 'Mehta', 'Affiliation': ""Department of Neuroimaging,Institute of Psychiatry, Psychology, and Neuroscience, King's College London,London,UK.""}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': ""O'Daly"", 'Affiliation': ""Department of Neuroimaging,Institute of Psychiatry, Psychology, and Neuroscience, King's College London,London,UK.""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Zelaya', 'Affiliation': ""Department of Neuroimaging,Institute of Psychiatry, Psychology, and Neuroscience, King's College London,London,UK.""}, {'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'Zahreddine', 'Affiliation': 'Department of Psychiatry,Saint-Joseph University,Beirut,Lebanon.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Keren', 'Affiliation': 'Mood Brain and Development Unit, Emotion and Development Branch,National Institute of Mental Health, National Institutes of Health,MD,USA.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': ""O'Callaghan"", 'Affiliation': 'Mood Brain and Development Unit, Emotion and Development Branch,National Institute of Mental Health, National Institutes of Health,MD,USA.'}, {'ForeName': 'Allan H', 'Initials': 'AH', 'LastName': 'Young', 'Affiliation': ""Department of Psychological Medicine,Institute of Psychiatry, Psychology, and Neuroscience, King's College London,London,UK.""}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Leibenluft', 'Affiliation': 'Section on Mood Dysregulation and Neuroscience, Emotion and Development Branch,National Institute of Mental Health, National Institutes of Health,MD,USA.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Pine', 'Affiliation': 'Section on Development and Affective Neuroscience, Emotion and Development Branch,National Institute of Mental Health,MD,USA.'}, {'ForeName': 'Argyris', 'Initials': 'A', 'LastName': 'Stringaris', 'Affiliation': 'Mood Brain and Development Unit, Emotion and Development Branch,National Institute of Mental Health, National Institutes of Health,MD,USA.'}]",Psychological medicine,['10.1017/S0033291718003306']
1465,32408551,Changing Exposure Perceptions: A Randomized Controlled Trial of an Intervention with Smoking Parents.,"Children who live with smokers are at risk of poor health, and of becoming smokers themselves. Misperceptions of the nature of tobacco smoke exposure have been demonstrated among parents, resulting in continued smoking in their children's environment. This study aimed to change parents' perceptions of exposure by providing information on second- and third-hand exposure and personalised information on children's exposure [NIH registry (NCT02867241)]. One hundred and fifty-nine families with a child < 8 years and at least one smoking parent were randomized into intervention (69), control (70), and enhanced control (20) groups. Reported exposure, parental smoking details, and a child hair sample were obtained at the start of the study and 6-8 months later. Parental perceptions of exposure (PPE) were assessed via a questionnaire. The intervention consisted of motivational interviews, feedback of home air quality and child's hair nicotine level, and information brochures. PPE were significantly higher at the study end (94.6 ± 17.6) compared to study beginning (86.5 ± 19.3) in intervention and enhanced control groups (t(72) = -3.950;  p  < 0.001). PPE at study end were significantly higher in the intervention group compared to the regular control group ( p  = 0.020). There was no significant interaction between time and group. Parallel changes in parental smoking behaviour were found. Parental perceptions of exposure were increased significantly post intervention, indicating that they can be altered. By making parents more aware of exposure and the circumstances in which it occurs, we can help parents change their smoking behaviour and better protect their children.",2020,PPE at study end were significantly higher in the intervention group compared to the regular control group ( p  = 0.020).,"['Children who live with smokers', 'One hundred and fifty-nine families with a child < 8 years and at least one smoking parent']","[""motivational interviews, feedback of home air quality and child's hair nicotine level, and information brochures""]","['parental smoking behaviour', 'PPE', 'Parental perceptions of exposure (PPE']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C2371710', 'cui_str': 'Air Quality'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0202431', 'cui_str': 'Nicotine measurement'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",159.0,0.0176672,PPE at study end were significantly higher in the intervention group compared to the regular control group ( p  = 0.020).,"[{'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Myers', 'Affiliation': 'Department of Health Promotion, School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Ramat Aviv, Tel Aviv 6997801, Israel.'}, {'ForeName': 'Shoshana', 'Initials': 'S', 'LastName': 'Shiloh', 'Affiliation': 'School of Psychological Sciences, Gershon H. Gordon Faculty of Social Sciences, Tel Aviv University, Ramat Aviv, Tel Aviv 6997801, Israel.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Zucker', 'Affiliation': 'Department of Statistics, Hebrew University, Mount Scopus, Jerusalem 9190501, Israel.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Rosen', 'Affiliation': 'Department of Health Promotion, School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Ramat Aviv, Tel Aviv 6997801, Israel.'}]",International journal of environmental research and public health,['10.3390/ijerph17103349']
1466,30083962,"Phase II randomized, double-blind, placebo-controlled study of tivantinib in men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC).","Background Tivantinib is a non-ATP competitive inhibitor of c-MET receptor tyrosine kinase that may have additional cytotoxic mechanisms including tubulin inhibition. Prostate cancer demonstrates higher c-MET expression as the disease progresses to more advanced stages and to a castration resistant state. Methods 80 patients (pts) with asymptomatic or minimally symptomatic mCRPC were assigned (2:1) to either tivantinib 360 mg PO BID or placebo (P). The primary endpoint was progression free survival (PFS). Results Of the 80 pts. enrolled, 78 (52 tivantinib, 26 P) received treatment and were evaluable. Median follow up is 8.9 months (range: 2.3 to 19.6 months). Patients treated with tivantinib had significantly better PFS vs. those treated with placebo (medians: 5.5 mo vs 3.7 mo, respectively; HR = 0.55, 95% CI: 0.33 to 0.90; p = 0.02). Grade 3 febrile neutropenia was seen in 1 patient on tivantinib while grade 3 and 4 neutropenia was recorded in 1 patient each on tivantinib and placebo. Grade 3 sinus bradycardia was recorded in two men on the tivantinib arm. Conclusions Tivantinib has mild toxicity and improved PFS in men with asymptomatic or minimally symptomatic mCRPC.",2018,Patients treated with tivantinib had significantly better PFS vs. those treated with placebo (medians:,"['men with asymptomatic or minimally symptomatic mCRPC', 'men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC', 'enrolled, 78 (52 tivantinib, 26 P) received treatment and were evaluable', '80 patients (pts) with asymptomatic or minimally symptomatic mCRPC']","['tivantinib 360', 'tivantinib', 'placebo', 'placebo (P']","['Grade 3 febrile neutropenia', 'Grade 3 sinus bradycardia', 'neutropenia', 'mild toxicity and improved PFS', 'progression free survival (PFS']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C2987651'}, {'cui': 'C0094014', 'cui_str': '26-P'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C2987651'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0085610', 'cui_str': 'Sinus bradycardia (disorder)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",80.0,0.217087,Patients treated with tivantinib had significantly better PFS vs. those treated with placebo (medians:,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Monk', 'Affiliation': 'Ohio State University, A433b Starling-Loving Hall, 310 W. 10th ave, Columbus, OH, 43082, USA. Paul.monk@osumc.edu.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, 1111 Highland Ave, Madison, WI, 53705, USA.'}, {'ForeName': 'Walter M', 'Initials': 'WM', 'LastName': 'Stadler', 'Affiliation': 'University of Chicago, 5841 S Maryland Ave, Chicago, IL, 60637, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Geyer', 'Affiliation': 'University of South Florida, 4202 E Fowler Ave, Tampa, FL, 33620, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Ohio State University, 320 W 10th Ave, Columbus, OH, 43210-1280, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wright', 'Affiliation': 'National Cancer Institute, 9609 Medical Center Dr., MSC, Bethesda, MD, 9739, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Villalona-Calero', 'Affiliation': 'Miami Cancer Institute, 8900 N Kendall Dr, Miami, FL, 33176-2118, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wade', 'Affiliation': 'Cancer Care Specialists of Central Illinois, 210 W Mckinley Ave, Decatur, IL, 62526, USA.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Szmulewitz', 'Affiliation': 'University of Chicago Medical Center, 5841 S Maryland Ave # MC2115, Chicago, IL, 60637-1447, USA.'}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'University of Minnesota, 420 Delaware St SE, Minneapolis, MN, 55455-0341, USA.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Mortazavi', 'Affiliation': 'Ohio State University, 320 W 10th Ave, Columbus, OH, 43210-1280, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Dreicer', 'Affiliation': 'University of Virginia School of Medicine, PO Box 800716, Charlottesville, VA, 22908-0716, USA.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Pili', 'Affiliation': 'Indiana University, 535 Barnhill Drive, Indianapolis, IN, 46202, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Dawson', 'Affiliation': 'Georgetown-Lombardi Comprehensive Cancer Center, 3800 Reservoir Rd NW, Washington, DC, 20007-2113, USA.'}, {'ForeName': 'Saby', 'Initials': 'S', 'LastName': 'George', 'Affiliation': 'Roswell Park Cancer Institute, 6 Symphony Cir, Orchard Park, NY, 14127, USA.'}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Garcia', 'Affiliation': 'Taussig Cancer Institute, 9500 Euclid Ave, Cleveland, OH, 44195-0001, USA.'}]",Investigational new drugs,['10.1007/s10637-018-0630-9']
1467,30588680,Use of fosfomycin as targeted antibiotic prophylaxis before prostate biopsy: A prospective randomized study.,"OBJECTIVES


To investigate whether switching ciprofloxacin to fosfomycin in the case of fluoroquinolone-resistant rectal bacteria influences the incidence of infectious complications after transrectal prostate biopsy.
METHODS


From December 2015 until December 2017, patients undergoing prostate biopsy were randomly assigned to a control group or an intervention group in a prospective, open-label fashion at three different centers. The presence of fluoroquinolone-resistant organisms was detected by rectal swabs. Patients in the control group received ciprofloxacin. Patients in the intervention group received fosfomycin instead of ciprofloxacin in the case of fluoroquinolone-resistant bacteria on rectal swab culture. The primary end-point was the difference in occurrence of major (febrile) and minor (afebrile) infections between both groups.
RESULTS


A total of 102 patients were randomized to the control group, and 102 patients to the intervention group. In the control group, nine complications occurred, of which five were major febrile complications. In the intervention group, six complications occurred, of which four were major febrile complications. The total number of complications (major and minor) did not differ between both groups (P = 0.59). A subgroup analysis of patients with fluoroquinolone-resistant bacteria on rectal swab showed five complications in the control group and one complication in the intervention group (P = 0.09).
CONCLUSIONS


This represents the first prospective randomized study using rectal cultures for targeted antibiotic prophylaxis. Study findings show promising results for use of fosfomycin in patients with fluoroquinolone resistance.",2019,The total number of complications (major and minor) did not differ between both groups (P = 0.59).,"['patients with fluoroquinolone resistance', '102 patients were randomized to the control group, and 102 patients to the intervention group', 'From December 2015 until December 2017, patients undergoing prostate biopsy']","['ciprofloxacin', 'fluoroquinolone-resistant bacteria', 'fosfomycin instead of ciprofloxacin', 'fosfomycin']","['nine complications', 'major febrile complications', 'total number of complications (major and minor', 'occurrence of major (febrile) and minor (afebrile) infections']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0949665', 'cui_str': 'Fluoroquinolones'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]","[{'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C3656678', 'cui_str': 'Fluoroquinolone resistant bacteria (organism)'}, {'cui': 'C0016610', 'cui_str': 'Fosfomycin'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",102.0,0.0889959,The total number of complications (major and minor) did not differ between both groups (P = 0.59).,"[{'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Van Besien', 'Affiliation': 'Department of Urology, AZ Sint-Lucas Hospital, Ghent, Belgium.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Uvin', 'Affiliation': 'Department of Urology, AZ Sint-Lucas Hospital, Ghent, Belgium.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Weyne', 'Affiliation': 'Department of Urology, AZ Sint-Lucas Hospital, Ghent, Belgium.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Van Praet', 'Affiliation': 'Department of Urology, AZ Sint-Lucas Hospital, Ghent, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Merckx', 'Affiliation': 'Department of Urology, AZ Sint-Lucas Hospital, Ghent, Belgium.'}, {'ForeName': 'Nico', 'Initials': 'N', 'LastName': 'De Graeve', 'Affiliation': 'Department of Urology, AZ Sint-Lucas Hospital, Ghent, Belgium.'}, {'ForeName': 'Koenraad', 'Initials': 'K', 'LastName': 'Van Renterghem', 'Affiliation': 'Department of Urology, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Reinoud', 'Initials': 'R', 'LastName': 'Cartuyvels', 'Affiliation': 'Department of Microbiology, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Van den Abeele', 'Affiliation': 'Department of Microbiology, AZ Sint-Lucas Hospital, Ghent, Belgium.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.13883']
1468,30282699,Impact of Gastric Banding Versus Metformin on β-Cell Function in Adults With Impaired Glucose Tolerance or Mild Type 2 Diabetes.,"OBJECTIVE


Type 2 diabetes (T2D) results from progressive loss of β-cell function. The BetaFat study compared gastric banding and metformin for their impact on β-cell function in adults with moderate obesity and impaired glucose tolerance (IGT) or recently diagnosed, mild T2D.
RESEARCH DESIGN AND METHODS


Eighty-eight people aged 21-65 years, BMI 30-40 kg/m 2 , with IGT or diabetes known for <1 year, were randomized to gastric banding or metformin for 2 years. Hyperglycemic clamps (11.1 mmol/L) followed by arginine injection at maximally potentiating glycemia (>25 mmol/L) were performed at baseline, 12 months, and 24 months to measure steady-state C-peptide (SSCP) and acute C-peptide response to arginine at maximum glycemic potentiation (ACPRmax) and insulin sensitivity (M/I).
RESULTS


At 24 months, the band group lost 10.7 kg; the metformin group lost 1.7 kg ( P  < 0.01). Insulin sensitivity increased 45% in the band group and 25% in the metformin group ( P  = 0.30 between groups). SSCP adjusted for insulin sensitivity fell slightly but not significantly in each group ( P  = 0.34 between groups). ACPRmax adjusted for insulin sensitivity fell significantly in the metformin group ( P  = 0.002) but not in the band group ( P  = 0.25 between groups). HbA 1c  fell at 12 and 24 months in the band group ( P  < 0.004) but only at 12 months ( P  < 0.01) in the metformin group ( P  > 0.14 between groups). Normoglycemia was present in 22% and 15% of band and metformin groups, respectively, at 24 months ( P  = 0.66 between groups).
CONCLUSIONS


Gastric banding and metformin had similar effects to preserve β-cell function and stabilize or improve glycemia over a 2-year period in moderately obese adults with IGT or recently diagnosed, mild T2D.",2018,Insulin sensitivity increased 45% in the band group and 25% in the metformin group ( P  = 0.30 between groups).,"['moderately obese adults with IGT or recently diagnosed, mild T2D', 'adults with moderate obesity and impaired glucose tolerance (IGT) or recently diagnosed, mild T2D', 'Adults With Impaired Glucose Tolerance or Mild Type 2 Diabetes', 'Eighty-eight people aged 21-65 years, BMI 30-40 kg/m 2 , with IGT or diabetes known for <1 year']","['metformin', 'Gastric Banding Versus Metformin', 'Gastric banding and metformin', 'Hyperglycemic clamps', 'gastric banding or metformin', 'gastric banding and metformin']","['steady-state C-peptide (SSCP) and acute C-peptide response to arginine at maximum glycemic potentiation (ACPRmax) and insulin sensitivity (M/I', 'β-cell function', 'HbA 1c  fell', 'SSCP adjusted for insulin sensitivity fell', 'ACPRmax adjusted for insulin sensitivity fell', 'Normoglycemia', 'β-Cell Function', 'Insulin sensitivity', 'β-cell function and stabilize or improve glycemia']","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0271650', 'cui_str': 'Glucose Intolerance'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C3854330', 'cui_str': 'Gastric band (physical object)'}, {'cui': 'C1960832', 'cui_str': 'Partitioning of stomach using band (procedure)'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}]","[{'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0968133', 'cui_str': 'alpha-(trifluoromethyl)arginine'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0243031', 'cui_str': 'SSCP'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",88.0,0.0382476,Insulin sensitivity increased 45% in the band group and 25% in the metformin group ( P  = 0.30 between groups).,"[{'ForeName': 'Anny H', 'Initials': 'AH', 'LastName': 'Xiang', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA buchanan@usc.edu anny.h.xiang@kp.org.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Trigo', 'Affiliation': 'Division of Endocrinology and Diabetes, Department of Medicine, Keck School of Medicine of the University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Mayra', 'Initials': 'M', 'LastName': 'Martinez', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA.'}, {'ForeName': 'Namir', 'Initials': 'N', 'LastName': 'Katkhouda', 'Affiliation': 'Department of Surgery, Keck School of Medicine of the University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Beale', 'Affiliation': 'Division of Endocrinology and Diabetes, Department of Medicine, Keck School of Medicine of the University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Xinhui', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Chow', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA.'}, {'ForeName': 'Cortney', 'Initials': 'C', 'LastName': 'Montgomery', 'Affiliation': 'Department of Surgery, Keck School of Medicine of the University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Krishna S', 'Initials': 'KS', 'LastName': 'Nayak', 'Affiliation': 'Ming Hsieh Department of Electrical Engineering, Viterbi School of Engineering, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Fadi', 'Initials': 'F', 'LastName': 'Hendee', 'Affiliation': 'Division of Endocrinology, Clinical Nutrition and Metabolism, Department of Internal Medicine, University of Nevada Reno School of Medicine, Reno, NV.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Buchanan', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc18-1662']
1469,31675083,Effect of Escalating Financial Incentive Rewards on Maintenance of Weight Loss: A Randomized Clinical Trial.,"Importance


Identifying effective strategies for treating obesity is a public health priority.
Objective


To test an escalating lottery-based incentive tied to daily self-weighing for weight loss maintenance.
Design, Setting, and Participants


This 2-phase, 2-arm randomized clinical trial enrolled participants aged 30 to 80 years with an initial body mass index (calculated as weight in kilograms divided by height in meters squared) of 30.0 to 45.0 who lost at least 5 kg during 4 to 6 months in a national online weight management program. Study investigators and outcomes assessors were blinded to participant groups. Data were collected and analyzed from May 23, 2016, through November 13, 2017, based on intention to treat.
Interventions


All participants were advised to weigh themselves daily, with a goal of 6 or more days per week, and received text messaging feedback on their performance. Incentive group participants were eligible for a lottery-based incentive worth an expected value of $3.98 in week 1 that escalated by $0.43 each week they achieved their self-weighing goal during months 1 to 6 (phase 1), followed by no incentives during months 7 to 12 (phase 2).
Main Outcomes and Measures


The primary outcome was weight change at the end of phase 1. Secondary outcomes included weight change at the end of phase 2 and changes in self-reported physical activity and eating behaviors.
Results


A total of 258 participants (128 in the incentive group and 130 in the control group) had a mean (SD) age of 48.0 (10.5) years and mean (SD) body mass index of 32.1 (3.9); 225 (87.2%) were women; 235 (91.1%) were white; and 102 (39.5%) had an annual income of at least $100 000. Weight measurement was transmitted by 250 participants (96.9%) at 6 months and 227 (88.0%) at 12 months. The percentage of weeks that incentive and control participants achieved a mean self-weighing of at least 6 times was 85.3% vs 75.8%, respectively (P = .002) in phase 1 and 37.7% vs 50.2%, respectively (P = .009) in phase 2. Mean weight changes at the end of phase 1 were -1.1 (95% CI, -2.1 to -0.1) kg in the incentive group and -1.9 (95% CI, -2.9 to -0.8) kg in the control group, with a mean difference of 0.7 (95% CI, -0.7 to 2.2) kg (P = .30 for comparison). At the end of phase 2, mean weight changes were 0.2 (95% CI, -1.2 to 1.7) kg in the incentive group and -0.6 (95% CI, -2.0 to 0.8) kg in the control group, with a mean difference of 0.8 (95% CI, -1.2 to 2.8) kg (P = .41 for comparison).
Conclusions and Relevance


Compared with an active control condition of weekly messages, escalating lottery-based incentives transiently increased rates of self-weighing but did not significantly enhance weight loss maintenance.
Trial Registration


ClinicalTrials.gov identifier: NCT01900392.",2019,"Compared with an active control condition of weekly messages, escalating lottery-based incentives transiently increased rates of self-weighing but did not significantly enhance weight loss maintenance.
","['participants aged 30 to 80 years with an initial body mass index (calculated as weight in kilograms divided by height in meters squared) of 30.0 to 45.0 who lost at least 5 kg during 4 to 6 months in a national online weight management program', '258 participants (128 in the incentive group and 130 in the control group) had a mean (SD) age of 48.0 (10.5) years and mean (SD) body mass index of 32.1 (3.9); 225 (87.2%) were women; 235 (91.1%) were white; and 102 (39.5%) had an annual income of at least $100\u202f000']","['Escalating Financial Incentive Rewards', 'text messaging feedback']","['mean weight changes', 'weight change', 'weight change at the end of phase 2 and changes in self-reported physical activity and eating behaviors', 'Weight measurement', 'Mean weight changes', 'weight loss maintenance', 'Maintenance of Weight Loss', 'rates of self-weighing', 'mean self-weighing of at least 6 times']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C4517698', 'cui_str': '3.9 (qualifier value)'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",258.0,0.275239,"Compared with an active control condition of weekly messages, escalating lottery-based incentives transiently increased rates of self-weighing but did not significantly enhance weight loss maintenance.
","[{'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Yancy', 'Affiliation': 'Duke University Diet and Fitness Center, Durham, North Carolina.'}, {'ForeName': 'Pamela A', 'Initials': 'PA', 'LastName': 'Shaw', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Reale', 'Affiliation': 'Leonard Davis Institute Center for Health Incentives and Behavioral Economics, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Hilbert', 'Affiliation': 'Leonard Davis Institute Center for Health Incentives and Behavioral Economics, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Jiali', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Jingsan', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Leonard Davis Institute Center for Health Incentives and Behavioral Economics, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Andrea B', 'Initials': 'AB', 'LastName': 'Troxel', 'Affiliation': 'Department of Population Health, New York University School of Medicine, New York.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Foster', 'Affiliation': 'Department of Science, WW (formerly Weight Watchers), New York, New York.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Volpp', 'Affiliation': 'Leonard Davis Institute Center for Health Incentives and Behavioral Economics, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.14393']
1470,31675086,"Effectiveness of Universal School-Based Screening vs Targeted Screening for Major Depressive Disorder Among Adolescents: A Trial Protocol for the Screening in High Schools to Identify, Evaluate, and Lower Depression (SHIELD) Randomized Clinical Trial.","Importance


The prevalence of annual major depressive disorder (MDD) episodes among adolescents in the United States rose from 8.3% in 2008 to 12.8% in 2016. Despite the US Preventive Services Task Force 2009 endorsement and 2016 reaffirmation of universal adolescent MDD screening in primary care, many adolescents are missed, as more than 60% lack annual preventive health visits and MDD screening remains inconsistent.
Objective


To compare the effectiveness of universal school-based screening for adolescent MDD vs the existing process of targeted screening based on observable behavior.
Design, Setting, and Participants


Screening in High Schools to Identify, Evaluate, and Lower Depression (SHIELD) is a randomized clinical trial that will take place in at least 8 Pennsylvania public high schools among at least 9650 students enrolled in 9th through 12th grade. Students will be randomized by grade to either targeted screening (current process) or universal screening (intervention). Students in the targeted screening arm will complete mandated school health screenings, which do not include an MDD screening. These students will be observed through the academic year for referral to the Student Assistance Program (SAP), required in all Pennsylvania schools. If a student exhibits behavior concerning for MDD raised by any contact (eg, teacher, parent, peer, or self-referral), SAP will triage the student and provide follow-up recommendations. Students in the universal screening arm will complete the validated Patient Health Questionnaire-9 (PHQ-9) from September through December of the academic year. The PHQ-9 includes 9 close-ended questions and is scored from 0 to 27. Students with a positive result (ie, score >10) will proceed to SAP triage. Students in the intervention arm will also be observed for behavior concerning for MDD during the school year, potentially prompting SAP triage referral. The primary outcome will be the proportion of adolescents referred to SAP triage who are recommended for additional MDD-related services and successfully engage with at least 1 SAP recommendation. Observers will not be blinded to patient groups, and an intention-to-treat analysis will be used.
Discussion


The SHIELD trial began with 3 schools during the 2018-2019 academic year. Screening in the intervention arm with the PHQ-9 is currently underway for the remaining schools, with a goal of completion of all PHQ-9 screenings by December 2019. This trial addresses the US Preventive Services Task Force call for large, high-quality randomized clinical trials to better understand the effects of MDD screening and quantify the proportion of adolescents with screen-detected MDD successfully referred and treated.
Trial Registration


ClinicalTrials.gov identifier: NCT03716869.",2019,The primary outcome will be the proportion of adolescents referred to SAP triage who are recommended for additional MDD-related services and successfully engage with at least 1 SAP recommendation.,"['Students with a positive result', 'least 8 Pennsylvania public high schools among at least 9650 students enrolled in 9th through 12th grade', '3 schools during the 2018-2019 academic year', 'Major Depressive Disorder', 'Adolescents', 'adolescents in the United States rose from 8.3% in 2008 to 12.8% in 2016', 'adolescents with screen-detected MDD successfully referred and treated']","['targeted screening (current process) or universal screening (intervention', 'Universal School-Based Screening vs Targeted Screening', 'universal school-based screening', 'universal adolescent MDD screening']","['prevalence of annual major depressive disorder (MDD) episodes', 'proportion of adolescents referred to SAP triage who are recommended for additional MDD-related services and successfully engage with at least 1 SAP recommendation']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C4517547', 'cui_str': '12.8'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}]",2009.0,0.132386,The primary outcome will be the proportion of adolescents referred to SAP triage who are recommended for additional MDD-related services and successfully engage with at least 1 SAP recommendation.,"[{'ForeName': 'Deepa L', 'Initials': 'DL', 'LastName': 'Sekhar', 'Affiliation': 'Department of Pediatrics, Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Krista L', 'Initials': 'KL', 'LastName': 'Pattison', 'Affiliation': 'Department of Pediatrics, Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Confair', 'Affiliation': 'Department of Pediatrics, Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Alissa', 'Initials': 'A', 'LastName': 'Molinari', 'Affiliation': 'Department of Pediatrics, Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Eric W', 'Initials': 'EW', 'LastName': 'Schaefer', 'Affiliation': 'Department of Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Waxmonsky', 'Affiliation': 'Department of Psychiatry, Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Leslie R', 'Initials': 'LR', 'LastName': 'Walker-Harding', 'Affiliation': ""Department of Pediatrics, Seattle Children's, Seattle, Washington.""}, {'ForeName': 'Perri', 'Initials': 'P', 'LastName': 'Rosen', 'Affiliation': 'Garrett Lee Smith Youth Suicide Prevention Grant, Harrisburg, Pennsylvania.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Kraschnewski', 'Affiliation': 'Department of Pediatrics, Penn State College of Medicine, Hershey, Pennsylvania.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.14427']
1471,31668850,"Palbociclib plus exemestane with gonadotropin-releasing hormone agonist versus capecitabine in premenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer (KCSG-BR15-10): a multicentre, open-label, randomised, phase 2 trial.","BACKGROUND


Endocrine treatment is recommended by clinical guidelines as the preferred treatment option for premenopausal as well as postmenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer. In real-world clinical practice, however, a substantial number of patients are treated with chemotherapy. We aimed to compare the clinical antitumour activity and safety of palbociclib plus endocrine therapy with that of capecitabine chemotherapy in premenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer.
METHODS


This multicentre, open-label, randomised, phase 2 study was done in 14 academic institutions in South Korea. Premenopausal women aged 19 years or older with hormone receptor-positive, HER2-negative breast cancer that had relapsed or progressed during previous tamoxifen therapy and with an Eastern Cooperative Oncology Group performance status of 0-2 were included. One line of previous chemotherapy for metastatic breast cancer was allowed. Patients were randomly assigned, using a random permuted block design (with a block size of two), to receive palbociclib plus combination endocrine therapy (oral exemestane 25 mg per day for 28 days and oral palbociclib 125 mg per day for 21 days every 4 weeks plus leuprolide 3·75 mg subcutaneously every 4 weeks) or chemotherapy (oral capecitabine 1250 mg/m 2  twice daily for 2 weeks every 3 weeks). Randomisation was stratified by previous chemotherapy for metastatic breast cancer and visceral metastasis. The primary endpoint was progression-free survival. All analyses were done in a modified intention-to-treat population that excluded patients who did not receive study medication. This study is registered with ClinicalTrials.gov, NCT02592746, and is ongoing for follow-up of overall survival.
FINDINGS


Between June 15, 2016, and Dec 10, 2018, 189 patients were enrolled, of whom 184 were randomly assigned to the palbociclib plus endocrine therapy group (n=92) or the capecitabine group (n=92). Six patients in the capecitabine group withdrew from the study before drug administration; therefore, 92 patients in the palbociclib plus endocrine therapy group and 86 patients in the capecitabine group were included in the modified intention-to-treat analyses. 46 (50%) of 92 patients in the palbociclib plus endocrine therapy group and 45 (51%) of 92 in the capecitabine group were treatment naive for metastatic breast cancer. During a median follow-up of 17 months (IQR 9-22), median progression-free survival was 20·1 months (95% CI 14·2-21·8) in the palbociclib plus endocrine therapy group versus 14·4 months (12·1-17·0) in the capecitabine group (hazard ratio 0·659 [95% CI 0·437-0·994], one-sided log-rank p=0·0235). Treatment-related grade 3 or worse neutropenia was more common in the palbociclib plus endocrine therapy group than in the capecitabine group (69 [75%] of 92 vs 14 [16%] of 86 patients). 2 (2%) patients in the palbociclib plus endocrine therapy group and 15 (17%) patients in the capecitabine group had treatment-related serious adverse events. No treatment-related deaths occurred.
INTERPRETATION


Exemestane plus palbociclib with ovarian function suppression showed clinical benefit compared with capecitabine in terms of improved progression-free survival in premenopausal patients with hormone receptor-positive, HER2-negative metastatic breast cancer. Palbociclib plus exemestane with ovarian suppression is an active treatment option in premenopausal patients with hormone receptor-positive, HER2-negative metastatic breast cancer who have been pretreated with tamoxifen.
FUNDING


Pfizer, Shinpoong, and Daewoong Korea and Takeda.",2019,Treatment-related grade 3 or worse neutropenia was more common in the palbociclib plus endocrine therapy group than in the capecitabine group (69 [75%] of 92 vs 14 [16%] of 86 patients).,"['premenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer (KCSG-BR15-10', 'premenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer', 'postmenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer', 'Premenopausal women aged 19 years or older with hormone receptor-positive, HER2-negative breast cancer that had relapsed or progressed during previous tamoxifen therapy and with an Eastern Cooperative Oncology Group performance status of 0-2 were included', 'Six patients in the capecitabine group withdrew from the study before drug administration; therefore, 92 patients in the palbociclib plus endocrine therapy group and 86 patients in the', 'Between June 15, 2016, and Dec 10, 2018, 189 patients were enrolled, of whom 184', 'premenopausal patients with hormone receptor-positive, HER2-negative metastatic breast cancer', '14 academic institutions in South Korea', 'premenopausal patients with hormone receptor-positive, HER2-negative metastatic breast cancer who have been pretreated with']","['palbociclib plus endocrine therapy', 'capecitabine chemotherapy', 'Palbociclib plus exemestane with gonadotropin-releasing hormone agonist versus capecitabine', 'leuprolide', 'chemotherapy (oral capecitabine 1250', 'Palbociclib plus exemestane with ovarian suppression', 'palbociclib plus combination endocrine therapy (oral exemestane', 'capecitabine', 'tamoxifen']","['progression-free survival', 'median progression-free survival', 'treatment-related serious adverse events', 'Treatment-related grade 3 or worse neutropenia']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C4510392', 'cui_str': 'Tamoxifen therapy'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0150270', 'cui_str': 'Medication administration case management'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}]","[{'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0085272', 'cui_str': 'Leuprolide'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4517554', 'cui_str': 'One thousand two hundred and fifty'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}]",189.0,0.1161,Treatment-related grade 3 or worse neutropenia was more common in the palbociclib plus endocrine therapy group than in the capecitabine group (69 [75%] of 92 vs 14 [16%] of 86 patients).,"[{'ForeName': 'Yeon Hee', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea. Electronic address: yhparkhmo@skku.edu.'}, {'ForeName': 'Tae-Yong', 'Initials': 'TY', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Gun Min', 'Initials': 'GM', 'LastName': 'Kim', 'Affiliation': 'Division of Medical Oncology and Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Seok Yun', 'Initials': 'SY', 'LastName': 'Kang', 'Affiliation': 'Department of Hematology-Oncology, Ajou University School of Medicine, Suwon, South Korea.'}, {'ForeName': 'In Hae', 'Initials': 'IH', 'LastName': 'Park', 'Affiliation': 'Center for Breast Cancer, National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Jee Hyun', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea.'}, {'ForeName': 'Kyoung Eun', 'Initials': 'KE', 'LastName': 'Lee', 'Affiliation': 'Department of Hematology and Oncology, Ewha Womans University Hospital, Seoul, South Korea.'}, {'ForeName': 'Hee Kyung', 'Initials': 'HK', 'LastName': 'Ahn', 'Affiliation': 'Division of Medical Oncology and Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, South Korea.'}, {'ForeName': 'Moon Hee', 'Initials': 'MH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Inha University School of Medicine, Incheon, South Korea.'}, {'ForeName': 'Hee-Jun', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Han Jo', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Soonchunhyang University Hospital, Cheonan, South Korea.'}, {'ForeName': 'Jong In', 'Initials': 'JI', 'LastName': 'Lee', 'Affiliation': 'Division of Hematology-Oncology, Department of Internal Medicine, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, Wonju, South Korea.'}, {'ForeName': 'Su-Jin', 'Initials': 'SJ', 'LastName': 'Koh', 'Affiliation': 'Department of Hematology and Oncology, Ulsan University Hospital, Ulsan University College of Medicine, Ulsan, South Korea.'}, {'ForeName': 'Ji-Yeon', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Kyung-Hun', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Joohyuk', 'Initials': 'J', 'LastName': 'Sohn', 'Affiliation': 'Division of Medical Oncology and Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sung-Bae', 'Initials': 'SB', 'LastName': 'Kim', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jin-Seok', 'Initials': 'JS', 'LastName': 'Ahn', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Young-Hyuck', 'Initials': 'YH', 'LastName': 'Im', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Kyung Hae', 'Initials': 'KH', 'LastName': 'Jung', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30565-0']
1472,32408692,The Wildman Programme. A Nature-Based Rehabilitation Programme Enhancing Quality of Life for Men on Long-Term Sick Leave: Study Protocol for a Matched Controlled Study In Denmark.,"Many men have poor mental health and need help to recover. However, designing a rehabilitation intervention that appeals to men is challenging. This study protocol aims to describe the 'Wildman Programme', which will be a nature-based rehabilitation programme for men on long-term sick leave due to health problems such as stress, anxiety, depression, post-cancer and chronic cancer, chronic obstructive pulmonary disease (COPD), cardiovascular disease, or diabetes type II. The programme will be a nature-based rehabilitation initiative combining nature experiences, attention training, body awareness training, and supporting community spirit. The aim of the study will be to examine whether the 'Wildman Programme' can help to increase quality of life and reduce stress among men with health problems compared to treatment as usual. The study will be a matched control study where an intervention group (number of respondents,  N  = 52) participating in a 12-week nature-based intervention will be compared to a control group ( N  = 52) receiving treatment as usual. Outcomes are measured at baseline (T1), post-treatment (T2), and at follow up 6 months post-intervention (T3). The results of this study will be important to state whether the method in the 'Wildman Programme' can be implemented as a rehabilitation offer in the Danish Healthcare System to help men with different health problems.",2020,The aim of the study will be to examine whether the 'Wildman Programme' can help to increase quality of life and reduce stress among men with health problems compared to treatment as usual.,['men with health problems'],['control group ( N  = 52) receiving treatment as usual'],"['quality of life and reduce stress', 'Quality of Life']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",52.0,0.0257458,The aim of the study will be to examine whether the 'Wildman Programme' can help to increase quality of life and reduce stress among men with health problems compared to treatment as usual.,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Høegmark', 'Affiliation': 'Department of Psychology, University of Southern Denmark, 5230 Odense M, Denmark.'}, {'ForeName': 'Tonny Elmose', 'Initials': 'TE', 'LastName': 'Andersen', 'Affiliation': 'Department of Psychology, University of Southern Denmark, 5230 Odense M, Denmark.'}, {'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Grahn', 'Affiliation': 'Department of Work Science, Business Economics and Environmental Psychology, Swedish University of Agricultural Sciences, SE-230 53 Alnarp, Sweden.'}, {'ForeName': 'Kirsten Kaya', 'Initials': 'KK', 'LastName': 'Roessler', 'Affiliation': 'Department of Psychology, University of Southern Denmark, 5230 Odense M, Denmark.'}]",International journal of environmental research and public health,['10.3390/ijerph17103368']
1473,30571292,Managing free-living hyperglycemia with exercise or interrupted sitting in type 2 diabetes.,"Breaking up sitting with light physical activity (PA) is effective in reducing hyperglycemia in the laboratory. Whether the same effects are observed in the free-living environment remains unknown. We evaluated how daily and postprandial glycemia is impacted by 20, 40, or 60 min of activity performed as either breaks from sitting after each meal (BR) or as one continuous walk after breakfast (WALK). Thirty individuals with type 2 diabetes completed three experimental conditions [BR, WALK, and control (CON)] in a randomized crossover design. Conditions were performed in a free-living environment with strict dietary control over 7 days. Participants increased PA in BR and WALK by 20, 40, or 60 min ( n = 10 in each group) and maintained habitual levels of PA during CON. A continuous glucose monitor (iPro2) and activPAL activity monitor were worn to quantify glycemic control and PA. Using linear mixed models with repeated measures, we 1) compared postprandial glucose (PPG) across conditions and 2) assessed the relationship between activity volume and glucose responses. Whereas WALK tended to shorten the daily duration of hyperglycemia compared with CON ( P = 0.0875), BR was not different from CON. BR and WALK significantly attenuated the breakfast PPG versus CON ( P ≤ 0.05), but lunch and dinner PPG were unaffected by BR and WALK. In conclusion, continuous walking was more effective than breaks from sitting in lowering daily hyperglycemia for the group, but both conditions lowered breakfast PPG. In contrast to tightly controlled laboratory studies, breaks from sitting did not lower hyperglycemia in the free-living environment. NEW & NOTEWORTHY Our ""ecolabical"" approach is new and noteworthy. This approach combines the external validity of the free-living environment (ecological) with the control of key confounding variables in the laboratory and allows for highly translatable findings by minimizing confounding variables. We found that both postmeal continuous walking and short breaks from sitting similarly attenuated the postprandial glucose (PPG) response to breakfast. Unlike previous laboratory studies, neither condition (walk after breakfast or postmeal breaks) significantly impacted PPG at lunch or dinner.",2019,"BR and WALK significantly attenuated the breakfast PPG versus CON ( P ≤ 0.05), but lunch and dinner PPG were unaffected by BR and WALK.",['Thirty individuals with type 2 diabetes completed three'],"['experimental conditions [BR, WALK, and control (CON', 'exercise or interrupted sitting', 'Breaking up sitting with light physical activity (PA']","['postprandial glucose (PPG) response', 'daily duration of hyperglycemia', 'BR and WALK', 'hyperglycemia', 'lunch and dinner PPG', 'postprandial glucose (PPG) across conditions and 2) assessed the relationship between activity volume and glucose responses']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0443239', 'cui_str': 'Interrupted (qualifier value)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C4552592', 'cui_str': 'With dinner'}, {'cui': 'C0049716', 'cui_str': 'thioGDP'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",30.0,0.0208578,"BR and WALK significantly attenuated the breakfast PPG versus CON ( P ≤ 0.05), but lunch and dinner PPG were unaffected by BR and WALK.","[{'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Blankenship', 'Affiliation': 'Department of Kinesiology, University of Massachusetts Amherst , Amherst, Massachusetts.'}, {'ForeName': 'Stuart R', 'Initials': 'SR', 'LastName': 'Chipkin', 'Affiliation': 'Department of Kinesiology, University of Massachusetts Amherst , Amherst, Massachusetts.'}, {'ForeName': 'Patty S', 'Initials': 'PS', 'LastName': 'Freedson', 'Affiliation': 'Department of Kinesiology, University of Massachusetts Amherst , Amherst, Massachusetts.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Staudenmayer', 'Affiliation': 'Department of Mathematics and Statistics, University of Massachusetts Amherst , Amherst, Massachusetts.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Lyden', 'Affiliation': 'KAL Consulting, Denver, Colorado.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Braun', 'Affiliation': 'Department of Kinesiology, University of Massachusetts Amherst , Amherst, Massachusetts.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00389.2018']
1474,31662328,Therapeutic hypothermia for neonatal hypoxic-ischaemic encephalopathy in India (THIN study): a randomised controlled trial.,"OBJECTIVE


To evaluate the neuroprotective effect of therapeutic hypothermia (TH) induced by phase changing material (PCM) on MRI biomarkers in infants with hypoxic-ischaemic encephalopathy (HIE) in a low-resource setting.
DESIGN


Open-label randomised controlled trial.
SETTING


One neonatal intensive care unit in a tertiary care centre in India.
PATIENTS


50 term/near-term infants admitted within 5 hours after birth with predefined physiological criteria and signs of moderate/severe HIE.
INTERVENTIONS


Standard care (n=25) or standard care plus 72 hours of hypothermia (33.5°C±0.5°C, n=25) induced by PCM.
MAIN OUTCOME MEASURES


Primary outcome was fractional anisotropy (FA) in the posterior limb of the internal capsule (PLIC) on neonatal diffusion tensor imaging analysed according to intention to treat.
RESULTS


Primary outcome was available for 22 infants (44%, 11 in each group). Diffusion tensor imaging showed significantly higher FA in the cooled than the non-cooled infants in left PLIC and several white matter tracts. After adjusting for sex, birth weight and gestational age, the mean difference in PLIC FA between groups was 0.026 (95% CI 0.004 to 0.048, p=0.023). Conventional MRI was available for 46 infants and demonstrated significantly less moderate/severe abnormalities in the cooled (n=2, 9%) than in the non-cooled (n=10, 43%) infants. There was no difference in adverse events between groups.
CONCLUSIONS


This study confirmed that TH induced by PCM reduced brain injury detected on MRI in infants with moderate HIE in a neonatal intensive care unit in India. Future research should focus on optimal supportive treatment during hypothermia rather than looking at efficacy of TH in low-resource settings.
TRIAL REGISTRATION NUMBER


CTRI/2013/05/003693.",2020,Diffusion tensor imaging showed significantly higher FA in the cooled than the non-cooled infants in left PLIC and several white matter tracts.,"['50 term/near-term infants admitted within 5\u2009hours after birth with predefined physiological criteria and signs of moderate/severe HIE', 'infants with moderate HIE in a neonatal intensive care unit in India', 'neonatal hypoxic-ischaemic encephalopathy in India (THIN study', 'infants with hypoxic-ischaemic encephalopathy (HIE) in a low-resource setting', 'One neonatal intensive care unit in a tertiary care centre in India']","['PCM', 'Standard care (n=25) or standard care plus 72\u2009hours of hypothermia', 'Therapeutic hypothermia', 'TH', 'therapeutic hypothermia (TH) induced by phase changing material (PCM']","['adverse events', 'MRI biomarkers', 'PLIC FA', 'moderate/severe abnormalities', 'fractional anisotropy (FA) in the posterior limb of the internal capsule (PLIC) on neonatal diffusion tensor imaging analysed according to intention to treat']","[{'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0456128', 'cui_str': 'Term infant (finding)'}, {'cui': 'C1442467', 'cui_str': '5 hours (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0752304', 'cui_str': 'Hypoxic-Ischemic Encephalopathy'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1292423', 'cui_str': '72 hours (qualifier value)'}, {'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}, {'cui': 'C0020674', 'cui_str': 'Targeted Temperature Management'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0152341', 'cui_str': 'Capsula Interna'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]",,0.202317,Diffusion tensor imaging showed significantly higher FA in the cooled than the non-cooled infants in left PLIC and several white matter tracts.,"[{'ForeName': 'Karoline', 'Initials': 'K', 'LastName': 'Aker', 'Affiliation': 'Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway karoline.aker@ntnu.no.'}, {'ForeName': 'Ragnhild', 'Initials': 'R', 'LastName': 'Støen', 'Affiliation': 'Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Live', 'Initials': 'L', 'LastName': 'Eikenes', 'Affiliation': 'Department of Circulation and Medical Imaging, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Martinez-Biarge', 'Affiliation': 'Department of Paediatrics, Imperial College London, London, UK.'}, {'ForeName': 'Ingeborg', 'Initials': 'I', 'LastName': 'Nakken', 'Affiliation': 'Norwegian Advisory Unit for Functional MRI, Department of Radiology, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Asta Kristine', 'Initials': 'AK', 'LastName': 'Håberg', 'Affiliation': 'Norwegian Advisory Unit for Functional MRI, Department of Radiology, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Sridhar', 'Initials': 'S', 'LastName': 'Gibikote', 'Affiliation': 'Department of Radiology, Christian Medical College and Hospital Vellore, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Niranjan', 'Initials': 'N', 'LastName': 'Thomas', 'Affiliation': 'Department of Neonatology, Christian Medical College and Hospital Vellore, Vellore, Tamil Nadu, India.'}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2019-317311']
1475,31664444,Effect of Combination l-Citrulline and Metformin Treatment on Motor Function in Patients With Duchenne Muscular Dystrophy: A Randomized Clinical Trial.,"Importance


Nitric oxide precursors, such as the amino acid l-arginine and the biguanide antidiabetic drug metformin, have been associated with metabolism and muscle function in patients with Duchenne muscular dystrophy (DMD). The treatment of DMD remains an unmet medical need.
Objective


To evaluate the benefits and harms of a combination of l-citrulline and metformin treatment among patients with DMD.
Design, Setting, and Participants


A single-center randomized double-blind placebo-controlled parallel-group clinical trial was conducted between December 12, 2013, and March 30, 2016, at the University Children's Hospital Basel in Switzerland. A total of 47 ambulant male patients aged 6.5 to 10 years with genetically confirmed DMD were recruited locally and from the patient registries of Switzerland, Germany, Austria, and France. Data were analyzed from April 6, 2016, to September 5, 2019.
Interventions


Patients in the treatment group received 2500 mg of l-citrulline and 250 mg of metformin (combination therapy) 3 times a day for 26 weeks compared with patients in the control group, who received placebo.
Main Outcomes and Measures


The primary end point was the change in transfer and standing posture, as assessed by the first dimension of the Motor Function Measure, version 32, from baseline to week 26. Secondary end points included assessments of timed function, quantitative muscle force, biomarkers for muscle necrosis, and adverse events. The 2 prespecified subgroups comprised patients who were able to walk 350 m or more in 6 minutes (stable subgroup) and patients who were not able to walk 350 m in 6 minutes (unstable subgroup) at baseline.
Results


Among 49 ambulant male children with DMD who were screened for eligibility, 47 patients with a mean (SD) age of 8.2 (1.1) years were randomized to a treatment group receiving combination therapy (n = 23) or a control group receiving placebo (n = 24), and 45 patients completed the study. No significant differences between groups were found in the results of timed function and muscle force tests for overall, proximal and axial, and distal motor function. Among patients receiving combination therapy, the Motor Function Measure first dimension subscore decrease was 5.5% greater than that of patients receiving placebo (95% CI, -1.0% to 12.1%; P = .09). The administration of combination therapy had significantly favorable effects on the first dimension subscore decrease among the 29 patients in the stable subgroup (6.7%; 95% CI, 0.9%-12.6%; P = .03) but not among the 15 patients in the unstable subgroup (3.9%; 95% CI, -13.2% to 20.9%; P = .63). Overall, the treatment was well tolerated with only mild adverse effects.
Conclusions and Relevance


Treatment with combination therapy was not associated with an overall reduction in motor function decline among ambulant patients with DMD; however, a reduction in motor function decline was observed among the stable subgroup of patients treated with combination therapy. The statistically nonsignificant difference of distal motor function in favor of combination therapy and the reduced degeneration of muscle tissue appear to support the treatment concept, but the study may have lacked sufficient statistical power. Further research exploring this treatment option with a greater number of patients is warranted.
Trial Registration


ClinicalTrials.gov identifier: NCT01995032.",2019,"No significant differences between groups were found in the results of timed function and muscle force tests for overall, proximal and axial, and distal motor function.","['47 ambulant male patients aged 6.5 to 10 years with genetically confirmed DMD were recruited locally and from the patient registries of Switzerland, Germany, Austria, and France', 'patients with Duchenne muscular dystrophy (DMD', 'ambulant patients with DMD', '47 patients with a mean (SD) age of 8.2 (1.1) years', 'patients with DMD', 'n\u2009=\u200924), and 45 patients completed the study', 'Patients With Duchenne Muscular Dystrophy', ""controlled parallel-group clinical trial was conducted between December 12, 2013, and March 30, 2016, at the University Children's Hospital Basel in Switzerland"", '49 ambulant male children with DMD who were screened for eligibility', 'patients who were able to walk 350 m or more in 6 minutes (stable subgroup) and patients who were not able to walk 350 m in 6 minutes (unstable subgroup) at baseline']","['l-citrulline and metformin', 'combination therapy', 'control group receiving placebo', 'Combination l-Citrulline and Metformin Treatment', 'placebo', '2500 mg of l-citrulline and 250 mg of metformin (combination therapy']","['motor function decline', 'change in transfer and standing posture, as assessed by the first dimension of the Motor Function Measure', 'distal motor function', 'timed function, quantitative muscle force, biomarkers for muscle necrosis, and adverse events', 'tolerated with only mild adverse effects', 'Motor Function', 'Motor Function Measure first dimension subscore decrease', 'first dimension subscore decrease', 'timed function and muscle force tests for overall, proximal and axial, and distal motor function']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0013264', 'cui_str': 'Cardiomyopathy, Dilated, X-Linked'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C2712089', 'cui_str': 'Able to walk (finding)'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0443343', 'cui_str': 'Unstable status (qualifier value)'}]","[{'cui': 'C0008864', 'cui_str': 'Citrulline'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319601', 'cui_str': '2500 (qualifier value)'}, {'cui': 'C2348831', 'cui_str': '250'}]","[{'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0235957', 'cui_str': 'Muscle necrosis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0205131', 'cui_str': 'Axial (qualifier value)'}]",47.0,0.146866,"No significant differences between groups were found in the results of timed function and muscle force tests for overall, proximal and axial, and distal motor function.","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Hafner', 'Affiliation': ""Division of Pediatric Neurology, University Children's Hospital Basel, Basel, Switzerland.""}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Bonati', 'Affiliation': ""Division of Pediatric Neurology, University Children's Hospital Basel, Basel, Switzerland.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Klein', 'Affiliation': ""Division of Pediatric Neurology, University Children's Hospital Basel, Basel, Switzerland.""}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Rubino', 'Affiliation': ""Division of Pediatric Neurology, University Children's Hospital Basel, Basel, Switzerland.""}, {'ForeName': 'Vanya', 'Initials': 'V', 'LastName': 'Gocheva', 'Affiliation': ""Division of Pediatric Neurology, University Children's Hospital Basel, Basel, Switzerland.""}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': ""Division of Pediatric Neurology, University Children's Hospital Basel, Basel, Switzerland.""}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Schroeder', 'Affiliation': ""Division of Pediatric Neurology, University Children's Hospital Basel, Basel, Switzerland.""}, {'ForeName': 'Günther', 'Initials': 'G', 'LastName': 'Bernert', 'Affiliation': 'Department of Pediatrics, Kaiser Franz Josef Hospital, Vienna, Austria.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Laugel', 'Affiliation': 'Department of Pediatric Neurology, Strasbourg University Hospital, Strasbourg, France.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Steinlin', 'Affiliation': 'Division of Pediatric Neurology, University of Berne Hospital, Berne, Switzerland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Capone', 'Affiliation': ""Division of Pediatric Neurology, Children's Hospital, Aarau, Switzerland.""}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Gloor', 'Affiliation': 'Division of Radiological Physics, Department of Radiology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Bieri', 'Affiliation': 'Division of Radiological Physics, Department of Radiology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Lars G', 'Initials': 'LG', 'LastName': 'Hemkens', 'Affiliation': 'Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Speich', 'Affiliation': 'Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Zumbrunn', 'Affiliation': 'Clinical Trial Unit, Department of Clinical Research, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Nuri', 'Initials': 'N', 'LastName': 'Gueven', 'Affiliation': 'Pharmacy, School of Medicine, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Fischer', 'Affiliation': ""Division of Pediatric Neurology, University Children's Hospital Basel, Basel, Switzerland.""}]",JAMA network open,['10.1001/jamanetworkopen.2019.14171']
1476,31657981,Improved CNS Control of Childhood Acute Lymphoblastic Leukemia Without Cranial Irradiation: St Jude Total Therapy Study 16.,"PURPOSE


Despite contemporary treatment, up to 10% of children with acute lymphoblastic leukemia still experience relapse. We evaluated whether a higher dosage of PEG-asparaginase and early intensification of triple intrathecal therapy would improve systemic and CNS control.
PATIENTS AND METHODS


Between 2007 and 2017, 598 consecutive patients age 0 to 18 years received risk-directed chemotherapy without prophylactic cranial irradiation in the St Jude Total Therapy Study 16. Patients were randomly assigned to receive PEG-asparaginase 3,500 U/m 2  versus the conventional 2,500 U/m 2 . Patients presenting features that were associated with increased risk of CNS relapse received two extra doses of intrathecal therapy during the first 2 weeks of remission induction.
RESULTS


The 5-year event-free survival and overall survival rates for the 598 patients were 88.2% (95% CI, 84.9% to 91.5%) and 94.1% (95% CI, 91.7% to 96.5%), respectively. Cumulative risk of any-isolated or combined-CNS relapse was 1.5% (95% CI, 0.5% to 2.5%). Higher doses of PEG-asparaginase did not affect treatment outcome. T-cell phenotype was the only independent risk factor for any CNS relapse (hazard ratio, 5.15; 95% CI, 1.3 to 20.6;  P  = . 021). Among 359 patients with features that were associated with increased risk for CNS relapse, the 5-year rate of any CNS relapse was significantly lower than that among 248 patients with the same features treated in the previous Total Therapy Study 15 (1.8% [95% CI, 0.4% to 3.3%]  v  5.7% [95% CI, 2.8% to 8.6%];  P  = .008). There were no significant differences in the cumulative risk of seizure or infection during induction between patients who did or did not receive the two extra doses of intrathecal treatment.
CONCLUSION


Higher doses of PEG-asparaginase failed to improve outcome, but additional intrathecal therapy during early induction seemed to contribute to improved CNS control without excessive toxicity for high-risk patients.",2019,"There were no significant differences in the cumulative risk of seizure or infection during induction between patients who did or did not receive the two extra doses of intrathecal treatment.
","['Between 2007 and 2017, 598 consecutive patients age 0 to 18 years received', '359 patients with features', 'children with acute lymphoblastic leukemia still experience relapse']","['PEG-asparaginase', 'risk-directed chemotherapy without prophylactic cranial irradiation', 'PEG-asparaginase 3,500 U/m 2  versus the conventional 2,500 U/m 2 ']","['cumulative risk of seizure or infection', 'risk for CNS relapse', 'risk of CNS relapse', '5-year event-free survival and overall survival rates', '5-year rate of any CNS relapse', 'Cumulative risk of any-isolated or combined-CNS relapse']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]","[{'cui': 'C0071568', 'cui_str': 'pegaspargase'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0079172', 'cui_str': 'Cranial Irradiation'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",598.0,0.0488517,"There were no significant differences in the cumulative risk of seizure or infection during induction between patients who did or did not receive the two extra doses of intrathecal treatment.
","[{'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Jeha', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Deqing', 'Initials': 'D', 'LastName': 'Pei', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Cheng', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Sandlund', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Coustan-Smith', 'Affiliation': 'National University of Singapore, Singapore.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Campana', 'Affiliation': 'National University of Singapore, Singapore.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Inaba', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Rubnitz', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Raul C', 'Initials': 'RC', 'LastName': 'Ribeiro', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Tanja A', 'Initials': 'TA', 'LastName': 'Gruber', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Susana C', 'Initials': 'SC', 'LastName': 'Raimondi', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Raja B', 'Initials': 'RB', 'LastName': 'Khan', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Jun J', 'Initials': 'JJ', 'LastName': 'Yang', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Mullighan', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Downing', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Evans', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Mary V', 'Initials': 'MV', 'LastName': 'Relling', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Ching-Hon', 'Initials': 'CH', 'LastName': 'Pui', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01692']
1477,32408817,Comparative Significance of Invasive Measures of Microvascular Injury in Acute Myocardial Infarction.,"BACKGROUND


The resistive reserve ratio (RRR) expresses the ratio between basal and hyperemic microvascular resistance. RRR measures the vasodilatory capacity of the microcirculation. We compared RRR, index of microcirculatory resistance (IMR), and coronary flow reserve (CFR) for predicting microvascular obstruction (MVO), myocardial hemorrhage, infarct size, and clinical outcomes, after ST-segment-elevation myocardial infarction.
METHODS


In the T-TIME trial (Trial of Low-Dose Adjunctive Alteplase During Primary PCI), 440 patients with acute ST-segment-elevation myocardial infarction from 11 UK hospitals were prospectively enrolled. In a subset of 144 patients, IMR, CFR, and RRR were measured post-primary percutaneous coronary intervention. MVO extent (% left ventricular mass) was determined by cardiovascular magnetic resonance imaging at 2 to 7 days. Infarct size was determined at 3 months. One-year major adverse cardiac events, heart failure hospitalizations, and all-cause death/heart failure hospitalizations were assessed.
RESULTS


In these 144 patients (mean age, 59±11 years, 80% male), median IMR was 29.5 (interquartile range: 17.0-55.0), CFR was 1.4 (1.1-2.0), and RRR was 1.7 (1.3-2.3). MVO occurred in 41% of patients. IMR>40 was multivariably associated with more MVO (coefficient, 0.53 [95% CI, 0.05-1.02];  P =0.031), myocardial hemorrhage presence (odds ratio [OR], 3.20 [95% CI, 1.25-8.24];  P =0.016), and infarct size (coefficient, 5.05 [95% CI, 0.84-9.26];  P =0.019), independently of CFR≤2.0, RRR≤1.7, myocardial perfusion grade≤1, and Thrombolysis in Myocardial Infarction frame count. RRR was multivariably associated with MVO extent (coefficient, -0.60 [95% CI, -0.97 to -0.23];  P =0.002), myocardial hemorrhage presence (OR, 0.34 [95% CI, 0.15-0.75];  P =0.008), and infarct size (coefficient, -3.41 [95% CI, -6.76 to -0.06];  P =0.046). IMR>40 was associated with heart failure hospitalization (OR, 5.34 [95% CI, 1.80-15.81]  P =0.002), major adverse cardiac events (OR, 4.46 [95% CI, 1.70-11.70]  P =0.002), and all-cause death/ heart failure hospitalization (OR, 4.08 [95% CI, 1.55-10.79]  P =0.005). RRR was associated with heart failure hospitalization (OR, 0.44 [95% CI, 0.19-0.99]  P =0.047). CFR was not associated with infarct characteristics or clinical outcomes.
CONCLUSIONS


In acute ST-segment-elevationl infarction, IMR and RRR, but not CFR, were associated with MVO, myocardial hemorrhage, infarct size, and clinical outcomes. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02257294.",2020,"IMR>40 was associated with heart failure hospitalization (OR, 5.34 [95% CI, 1.80-15.81]  P =0.002), major adverse cardiac events (OR, 4.46 [95% CI, 1.70-11.70]  P =0.002), and all-cause death/ heart failure hospitalization (OR, 4.08 [95% CI, 1.55-10.79]  P =0.005).","['440 patients with acute ST-segment-elevation myocardial infarction from 11 UK hospitals were prospectively enrolled', 'Acute Myocardial Infarction', '144 patients (mean age, 59±11 years, 80% male']",[],"['CFR', 'heart failure hospitalization', 'RRR', 'MVO', 'infarct size', 'Infarct size', 'RRR, index of microcirculatory resistance (IMR), and coronary flow reserve (CFR) for predicting microvascular obstruction (MVO), myocardial hemorrhage, infarct size, and clinical outcomes, after ST-segment-elevation myocardial infarction', 'myocardial hemorrhage presence', 'adverse cardiac events, heart failure hospitalizations, and all-cause death/heart failure hospitalizations', 'MVO, myocardial hemorrhage, infarct size, and clinical outcomes', 'IMR, CFR, and RRR', 'CFR≤2.0, RRR≤1.7, myocardial perfusion grade≤1, and Thrombolysis in Myocardial Infarction frame count', 'IMR>40', 'median IMR', 'major adverse cardiac events']","[{'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]",[],"[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0877077', 'cui_str': 'Myocardial haemorrhage'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",440.0,0.426171,"IMR>40 was associated with heart failure hospitalization (OR, 5.34 [95% CI, 1.80-15.81]  P =0.002), major adverse cardiac events (OR, 4.46 [95% CI, 1.70-11.70]  P =0.002), and all-cause death/ heart failure hospitalization (OR, 4.08 [95% CI, 1.55-10.79]  P =0.005).","[{'ForeName': 'Annette M', 'Initials': 'AM', 'LastName': 'Maznyczka', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.C.P., C.B.).'}, {'ForeName': 'Keith G', 'Initials': 'KG', 'LastName': 'Oldroyd', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.C.P., C.B.).'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Greenwood', 'Affiliation': 'Leeds University and Leeds Teaching Hospitals NHS Trust, United Kingdom (J.P.G.).'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'McCartney', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.C.P., C.B.).'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Cotton', 'Affiliation': 'Wolverhampton University Hospital NHS Trust, United Kingdom (J.C.).'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Lindsay', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.L., M.McE., J.P.R., R.G., K.R., H.E., S.W., A.S., C.B.).'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'McEntegart', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.L., M.McE., J.P.R., R.G., K.R., H.E., S.W., A.S., C.B.).'}, {'ForeName': 'J Paul', 'Initials': 'JP', 'LastName': 'Rocchiccioli', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.L., M.McE., J.P.R., R.G., K.R., H.E., S.W., A.S., C.B.).'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Good', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.L., M.McE., J.P.R., R.G., K.R., H.E., S.W., A.S., C.B.).'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Robertson', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.L., M.McE., J.P.R., R.G., K.R., H.E., S.W., A.S., C.B.).'}, {'ForeName': 'Hany', 'Initials': 'H', 'LastName': 'Eteiba', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.L., M.McE., J.P.R., R.G., K.R., H.E., S.W., A.S., C.B.).'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Watkins', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.L., M.McE., J.P.R., R.G., K.R., H.E., S.W., A.S., C.B.).'}, {'ForeName': 'Aadil', 'Initials': 'A', 'LastName': 'Shaukat', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.L., M.McE., J.P.R., R.G., K.R., H.E., S.W., A.S., C.B.).'}, {'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'Petrie', 'Affiliation': 'University Hospital Monklands, NHS Lanarkshire, United Kingdom (C.J.P.).'}, {'ForeName': 'Aengus', 'Initials': 'A', 'LastName': 'Murphy', 'Affiliation': ''}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Petrie', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.C.P., C.B.).'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, United Kingdom (A.M.M., K.G.O., P.J.M., M.C.P., C.B.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.008505']
1478,30548692,"Long-term safety and efficacy of antimuscarinic add-on therapy in patients with overactive bladder who had a suboptimal response to mirabegron monotherapy: A multicenter, randomized study in Japan (MILAI II study).","OBJECTIVES


To evaluate the long-term safety (primary objective) and efficacy (secondary objective) of antimuscarinic add-on therapy in patients receiving mirabegron.
METHODS


During a 2-week screening period, patients (aged ≥20 years, mirabegron treatment for ≥6 weeks, residual overactive bladder symptoms) received mirabegron 50 mg once daily. These patients were subsequently randomized to 52 weeks' treatment with mirabegron 50 mg/day plus an antimuscarinic (solifenacin 5 mg, propiverine 20 mg, imidafenacin 0.2 mg, or tolterodine 4 mg) with the potential to double the antimuscarinic dose (except for tolterodine) at week 8. Safety assessments included treatment-emergent adverse events, vital signs, 12-lead electrocardiograms, post-void residual volume, and laboratory evaluations. Efficacy was assessed using changes from baseline in overactive bladder symptom score total score; overactive bladder questionnaire short form score; micturitions, urgency episodes, urinary incontinence episodes, and urgency urinary incontinence episodes/24 h; mean volume voided per micturition; and number of night-time micturitions.
RESULTS


Overall, 80.2% of patients (88.1% women, mean age 65 years) experienced at least one treatment-emergent adverse event, with similar rates for all treatments. The adverse events most commonly reported were dry mouth, nasopharyngitis, and constipation. No marked change was observed in systolic or diastolic blood pressure for any treatment, although pulse rate increased slightly in the mirabegron and propiverine, and mirabegron and tolterodine groups. For all treatments, significant improvements were observed in all efficacy parameters, including overactive bladder symptom score total and questionnaire short form scores.
CONCLUSIONS


Antimuscarinic add-on therapy is well tolerated and effective after initial treatment with mirabegron in patients with overactive bladder symptoms.",2019,"For all treatments, significant improvements were observed in all efficacy parameters, including overactive bladder symptom score total and questionnaire short form scores.
","['patients with overactive bladder symptoms', 'patients with overactive bladder who had a suboptimal response to mirabegron monotherapy', 'patients receiving mirabegron', 'patients (aged ≥20\xa0years, mirabegron treatment for ≥6\xa0weeks, residual overactive bladder symptoms) received']","['mirabegron 50\xa0mg once daily', 'mirabegron 50\xa0mg/day plus an antimuscarinic (solifenacin 5\xa0mg, propiverine 20\xa0mg, imidafenacin 0.2\xa0mg, or tolterodine 4\xa0mg) with the potential to double the antimuscarinic dose (except for tolterodine']","['Efficacy', 'episodes/24\xa0h; mean volume voided per micturition; and number of night-time micturitions', 'systolic or diastolic blood pressure', 'overactive bladder symptom score total score; overactive bladder questionnaire short form score; micturitions, urgency episodes, urinary incontinence episodes, and urgency urinary incontinence', 'dry mouth, nasopharyngitis, and constipation', 'tolerated and effective', 'Safety assessments included treatment-emergent adverse events, vital signs, 12-lead electrocardiograms, post-void residual volume, and laboratory evaluations', 'overactive bladder symptom score total and questionnaire short form scores', 'pulse rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2983812', 'cui_str': 'mirabegron'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}]","[{'cui': 'C3474335', 'cui_str': 'mirabegron 50 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4521482', 'cui_str': 'Antimuscarinic'}, {'cui': 'C1099677', 'cui_str': 'Solifenacin'}, {'cui': 'C0138666', 'cui_str': 'propiverine'}, {'cui': 'C1876226', 'cui_str': 'imidafenacin'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0388753', 'cui_str': 'tolterodine'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0332300', 'cui_str': 'Except for (attribute)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518766'}, {'cui': 'C0430456', 'cui_str': '12 lead ECG'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume (observable entity)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0232117', 'cui_str': 'Pulse Rate'}]",,0.078883,"For all treatments, significant improvements were observed in all efficacy parameters, including overactive bladder symptom score total and questionnaire short form scores.
","[{'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Chemical Biology and Applied Chemistry, Nihon University School of Engineering, Koriyama, Japan.'}, {'ForeName': 'Hidehiro', 'Initials': 'H', 'LastName': 'Kakizaki', 'Affiliation': 'Department of Urology, Asahikawa Medical University, Asahikawa, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Homma', 'Affiliation': 'Department of Urology, The University of Tokyo Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yasuhiko', 'Initials': 'Y', 'LastName': 'Igawa', 'Affiliation': 'Department of Continence Medicine, The University of Tokyo Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Takeda', 'Affiliation': 'Department of Urology, Graduate Faculty of Interdisciplinary Research, University of Yamanashi, Chuo, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Nishizawa', 'Affiliation': 'Department of Urology, North Alps Medical Center, Azumi Hospital, Nagano, Japan.'}, {'ForeName': 'Momokazu', 'Initials': 'M', 'LastName': 'Gotoh', 'Affiliation': 'Department of Urology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Yoshida', 'Affiliation': 'Department of Urology, National Center for Geriatrics and Gerontology, Obu, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Yokoyama', 'Affiliation': 'Department of Urology, University of Fukui Faculty of Medical Sciences, Fukui, Japan.'}, {'ForeName': 'Narihito', 'Initials': 'N', 'LastName': 'Seki', 'Affiliation': 'Department of Urology, Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers, Fukuoka, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Okitsu', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Hamada', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Kobayashi', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Kuroishi', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.13868']
1479,30277850,Changes in nutrient intake and inflammation following an anti-inflammatory diet in spinal cord injury.,"Objective:  The objective of the current study was to describe the observed changes in nutrient intakes following a 3-month anti-inflammatory diet, and to explore potential relationships between the change in nutrients and the change in various inflammatory mediators. Design:  A secondary analysis of a prior randomized controlled clinical trial. Setting:  Individuals with SCI within the Niagara region. Participants:  Twenty individuals with various levels and severities of SCI. Intervention:  Three-month anti-inflammatory diet. Outcome Measures:  The change in nutrient intake and corresponding changes to various inflammatory mediators. Results:  The treatment group demonstrated a significant reduction in fat intake (P = 0.02), a significant increase in protein intake (P = 0.02), and no change in carbohydrates (P = 0.23) or energy intake (P = 0.10). The treatment group showed a significant increase in some nutrients with established anti-inflammatory properties including vitamins A, C, and E, and omega-3 fatty acids (P < 0.01). Significant reductions in proinflammatory nutrients were observed including trans fatty acids (P = 0.05), caffeine (P < 0.01), and sodium (P = 0.02). The treatment group also showed significant reductions in the proinflammatory mediators interferon-y (P = 0.01), interleukin-1β (P < 0.01), and interleukin-6 (P < 0.05). Further, several proinflammatory mediators were negatively correlated with anti-inflammatory nutrients, including vitamin A, carotenoids, omega-3 fatty acids, and zinc. Conclusion:  This study provides evidence that dietary alterations are effective at reducing chronic inflammation in individuals with SCI and provides a preliminary assessment of the related nutrient changes.",2019,"The treatment group also showed significant reductions in the proinflammatory mediators interferon-y (P = 0.01), interleukin-1β (P < 0.01), and interleukin-6 (P < 0.05).","['Individuals with SCI within the Niagara region', 'spinal cord injury', 'individuals with SCI', 'Twenty individuals with various levels and severities of SCI']",[],"['fat intake', 'some nutrients with established anti-inflammatory properties including vitamins A, C, and E, and omega-3 fatty acids', 'proinflammatory mediators interferon-y', 'energy intake', 'protein intake', 'trans fatty acids', 'change in carbohydrates', 'proinflammatory nutrients']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",[],"[{'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}]",20.0,0.0468138,"The treatment group also showed significant reductions in the proinflammatory mediators interferon-y (P = 0.01), interleukin-1β (P < 0.01), and interleukin-6 (P < 0.05).","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Allison', 'Affiliation': 'Department of Kinesiology, Brock University, St Catharines, Ontario, Canada.'}, {'ForeName': 'Kayleigh M', 'Initials': 'KM', 'LastName': 'Beaudry', 'Affiliation': 'Department of Kinesiology, Brock University, St Catharines, Ontario, Canada.'}, {'ForeName': 'Aysha M', 'Initials': 'AM', 'LastName': 'Thomas', 'Affiliation': 'Department of Kinesiology, Brock University, St Catharines, Ontario, Canada.'}, {'ForeName': 'Andrea R', 'Initials': 'AR', 'LastName': 'Josse', 'Affiliation': 'Department of Kinesiology, Brock University, St Catharines, Ontario, Canada.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Ditor', 'Affiliation': 'Department of Kinesiology, Brock University, St Catharines, Ontario, Canada.'}]",The journal of spinal cord medicine,['10.1080/10790268.2018.1519996']
1480,30721849,An examination of the relationship between hoarding symptoms and hostility.,"Hoarding disorder (HD) is a persistent and severe psychiatric condition in which individuals are unable to discard possessions, which results in considerable clutter. Individuals who hoard often endorse interpersonal difficulties and social isolation. However, little research has examined mechanisms that may help to explain this relationship. One possible mechanism is hostility, which is characterized by increased sensitivity to real or perceived social threats. The current study examined the relationship between hoarding symptoms and hostility across two undergraduate samples. In study 1, unselected undergraduates (N = 195) were administered measures of hoarding symptoms, hostile interpretations, and depression and anxiety symptoms. Participants in study 2 (N = 117) were selected for reporting elevated hoarding symptoms. Study 2 participants were administered the same measures as in study 1, and were additionally randomized to an inclusion or exclusion condition in a social exclusion manipulation. Total hoarding symptoms and hostile interpretations were positively associated across both samples, even when controlling for depression and anxiety. Further, greater hoarding symptoms were associated with increased feelings of hostility in response to social exclusion in study 2. Results suggest that increased sensitivity to social threat may confer risk for hoarding. These findings add to a growing body of research implicating interpersonal factors in the development and maintenance of hoarding disorder.",2019,"Total hoarding symptoms and hostile interpretations were positively associated across both samples, even when controlling for depression and anxiety.","['Individuals who hoard often endorse interpersonal difficulties and social isolation', 'unselected undergraduates (N\u202f=\u202f195', 'Participants in study 2 (N\u202f=\u202f117']",[],"['feelings of hostility', 'Total hoarding symptoms and hostile interpretations', 'hoarding symptoms, hostile interpretations, and depression and anxiety symptoms']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0424337', 'cui_str': 'Hoarding'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0020039', 'cui_str': 'Hostility'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424337', 'cui_str': 'Hoarding'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0459471', 'cui_str': 'Interpretation (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",195.0,0.0307474,"Total hoarding symptoms and hostile interpretations were positively associated across both samples, even when controlling for depression and anxiety.","[{'ForeName': 'Brittany M', 'Initials': 'BM', 'LastName': 'Mathes', 'Affiliation': 'Department of Psychology, Florida State University, USA.'}, {'ForeName': 'Grace A', 'Initials': 'GA', 'LastName': 'Kennedy', 'Affiliation': 'Department of Psychology, Florida State University, USA.'}, {'ForeName': 'Jesse R', 'Initials': 'JR', 'LastName': 'Cougle', 'Affiliation': 'Department of Psychology, Florida State University, USA.'}, {'ForeName': 'Norman B', 'Initials': 'NB', 'LastName': 'Schmidt', 'Affiliation': 'Department of Psychology, Florida State University, USA. Electronic address: schmidt@psy.fsu.edu.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2019.01.025']
1481,31545663,Romiplostim Treatment of Chemotherapy-Induced Thrombocytopenia.,"PURPOSE


Chemotherapy-induced thrombocytopenia (CIT) leads to delay or reduction in cancer treatment. There is no approved treatment.
METHODS


We conducted a phase II randomized trial of romiplostim versus untreated observation in patients with solid tumors with CIT. Before enrollment, patients had platelets less than 100,000/μL for at least 4 weeks, despite delay or dose reduction of chemotherapy. Patients received weekly titrated romiplostim with a target platelet count of 100,000/μL or more, or were monitored with usual care. The primary end point was correction of platelet count within 3 weeks. Twenty-three patients were treated in a randomization phase, and an additional 37 patients were treated in a single-arm, romiplostim phase. Resumption of chemotherapy without recurrent CIT was a secondary end point.
RESULTS


The mean platelet count at enrollment was 62,000/μL. In the randomization phase, 14 of 15 romiplostim-treated patients (93%) experienced correction of their platelet count within 3 weeks, compared with one of eight control patients (12.5%;  P  < .001). Including all romiplostim-treated patients (N = 52), the mean platelet count at 2 weeks of treatment was 141,000/μL. The mean platelet count in the eight observation patients at 3 weeks was 57,000/μL. Forty-four patients who achieved platelet correction with romiplostim resumed chemotherapy with weekly romiplostim. Only three patients (6.8%) experienced recurrent reduction or delay of chemotherapy because of isolated CIT.
CONCLUSION


This prospective trial evaluated treatment of CIT with romiplostim. Romiplostim is effective in correcting CIT, and maintenance allows for resumption of chemotherapy without recurrence of CIT in most patients.",2019,"Romiplostim is effective in correcting CIT, and maintenance allows for resumption of chemotherapy without recurrence of CIT in most patients.",['patients with solid tumors with CIT'],"['romiplostim', 'titrated romiplostim with a target platelet count of 100,000/μL or more, or were monitored with usual care']","['recurrent reduction or delay of chemotherapy', 'despite delay or dose reduction of chemotherapy', 'mean platelet count', 'correction of platelet count', 'correction of their platelet count']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0607063', 'cui_str': 'serum P-component'}]","[{'cui': 'C2364481', 'cui_str': 'romiplostim'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}]","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1299577', 'cui_str': 'Delay of chemotherapy'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}]",44.0,0.0328062,"Romiplostim is effective in correcting CIT, and maintenance allows for resumption of chemotherapy without recurrence of CIT in most patients.","[{'ForeName': 'Gerald A', 'Initials': 'GA', 'LastName': 'Soff', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Yimei', 'Initials': 'Y', 'LastName': 'Miao', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Bendheim', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Batista', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Jodi V', 'Initials': 'JV', 'LastName': 'Mones', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Rekha', 'Initials': 'R', 'LastName': 'Parameswaran', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Cy R', 'Initials': 'CR', 'LastName': 'Wilkins', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Devlin', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Ghassan K', 'Initials': 'GK', 'LastName': 'Abou-Alfa', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cercek', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Kemeny', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Debra M', 'Initials': 'DM', 'LastName': 'Sarasohn', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Mantha', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01931']
1482,31659541,Low-level laser therapy improves pain in postcesarean section: a randomized clinical trial.,"This study aimed to evaluate the effect of low-level laser therapy (LLLT) on immediate postpartum pain relief during cesarean section. A randomized, parallel controlled trial was carried out. In total, 88 women with immediate postpartum were divided into 4 groups: control group (n = 22), placebo group (n = 22), experimental group I (n = 22, dose of 4 J/cm 2 ), and experimental group II (n = 22, dose of 2 J/cm 2 ). The pain measured by Numeric Rating Scale (NRS), algometry, and Global Change Perception Scale (GCPS) was assessed at 12, 20-24, and 44-48 h postpartum. Two LLLT sessions were performed at 12 and 24 h postpartum. A significant interaction was observed between time versus group for NRS F (2.40) = 36.80, p < 0.001 and algometry F (1.70) = 27.18, p < 0.001. GCPS revealed a significant difference between the groups during second (p = 0.04) and third evaluation (p = 0.04). The NRS and algometry presented a large effect size for the experimental groups. LLLT is an efficient method to reduce pain and enhance the GCP in postcesarean section. No significant clinical differences were found between the laser doses.",2020,GCPS revealed a significant difference between the groups during second (p = 0.04) and third evaluation (p = 0.04).,"['immediate postpartum pain relief during cesarean section', '88 women with immediate postpartum', 'postcesarean section']","['LLLT', 'GCPS', 'placebo', 'low-level laser therapy (LLLT', 'Low-level laser therapy']","['pain', 'pain measured by Numeric Rating Scale (NRS), algometry, and Global Change Perception Scale (GCPS']","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0848200', 'cui_str': 'Afterbirth pain'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0032758', 'cui_str': 'Postcesarean Section'}]","[{'cui': 'C4019433', 'cui_str': 'LLLT'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0279027', 'cui_str': 'Low-Power Laser Therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",88.0,0.126879,GCPS revealed a significant difference between the groups during second (p = 0.04) and third evaluation (p = 0.04).,"[{'ForeName': 'Alane Macatrao Pires', 'Initials': 'AMP', 'LastName': 'de Holanda Araujo', 'Affiliation': 'Health Science Center, Federal University of Rio Grande do Norte, Natal, RN, Brazil.'}, {'ForeName': 'Kassio Rafael Rocha', 'Initials': 'KRR', 'LastName': 'de Sena', 'Affiliation': 'Faculdade Estácio, Natal, RN, Brazil.'}, {'ForeName': 'Edson Meneses', 'Initials': 'EM', 'LastName': 'da Silva Filho', 'Affiliation': 'Faculty of Health Science of Trairí, Graduate Program in Rehabilitation Science, Federal University of Rio Grande do Norte, Santa Cruz, RN, Brazil. meneses.edson@yahoo.com.br.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Pegado', 'Affiliation': 'Faculty of Health Science of Trairí, Graduate Program in Rehabilitation Science, Federal University of Rio Grande do Norte, Santa Cruz, RN, Brazil.'}, {'ForeName': 'Maria Thereza Albuquerque Barbosa Cabral', 'Initials': 'MTABC', 'LastName': 'Micussi', 'Affiliation': 'Health Science Center, Federal University of Rio Grande do Norte, Natal, RN, Brazil.'}]",Lasers in medical science,['10.1007/s10103-019-02893-3']
1483,31253718,Evidence that an intervention weakens the relationship between adolescent electronic cigarette use and tobacco smoking: a 24-month prospective study.,"BACKGROUND


The electronic cigarette (e-cigarette) use to subsequent smoking relationship in adolescents has received much attention. Whether an intervention to reduce smoking initiation attenuated this relationship was assessed.
METHOD


Data were from 3994 adolescent never smokers (aged 13-14 years at baseline) as part of a cluster randomised controlled trial. Self-report measures of smoking, e-cigarette use and covariates were assessed and used to predict ever smoked cigarettes, any recent tobacco smoking and regularly smoked cigarettes at 24-month follow-up.
RESULTS


Baseline ever use of e-cigarettes was associated with ever smoked cigarettes (OR=4.03, 95% CI 3.33 to 4.88; controlling for covariates, OR=2.78, 95% CI 2.20 to 3.51), any recent tobacco smoking (OR=3.38, 95% CI 2.72 to 4.21; controlling for covariates, OR=2.17, 95% CI 1.76 to 2.69) and regularly smoked cigarettes (OR=3.60, 95% CI 2.35 to 5.51; controlling for covariates, OR=1.27, 95% CI 1.17 to 1.39) at follow-up. For ever smoked cigarettes only, the impact of e-cigarette use was attenuated in the intervention (OR=1.83) compared with control (OR=4.53) condition. For ever smoked cigarettes and any recent tobacco smoking, the impact of e-cigarette use was attenuated among those with friends who smoked (OR=2.05 (ever smoked); 1·53 (any tobacco use)) compared with those without friends who smoked (OR=3.32 (ever smoked); 2·17 (any tobacco use)).
CONCLUSIONS


This is one of the first studies to show that e-cigarette use was robustly associated with measures of smoking over 24 months and the first to show an intervention to attenuate the relationship. Further research with a broader age range of adolescents is required.",2020,"For ever smoked cigarettes and any recent tobacco smoking, the impact of e-cigarette use was attenuated among those with friends who smoked (OR=2.05 (ever smoked); 1·53 (any tobacco use)) compared with those without friends who smoked (OR=3.32 (ever smoked); 2·17 (any tobacco use)).
",['Data were from 3994 adolescent never smokers (aged 13-14 years at baseline'],[],"['adolescent electronic cigarette use and tobacco smoking', 'regularly smoked cigarettes', 'recent tobacco smoking']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4280017', 'cui_str': 'E-Cig Use'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]",,0.0288669,"For ever smoked cigarettes and any recent tobacco smoking, the impact of e-cigarette use was attenuated among those with friends who smoked (OR=2.05 (ever smoked); 1·53 (any tobacco use)) compared with those without friends who smoked (OR=3.32 (ever smoked); 2·17 (any tobacco use)).
","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Conner', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, UK m.t.conner@leeds.ac.uk.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Grogan', 'Affiliation': 'Department of Psychology, Manchester Metropolitan University, Manchester, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Simms-Ellis', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Keira', 'Initials': 'K', 'LastName': 'Flett', 'Affiliation': 'Faculty of Health Sciences, Staffordshire University, Staffordshire, UK.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Sykes-Muskett', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Cowap', 'Affiliation': 'Faculty of Health Sciences, Staffordshire University, Staffordshire, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lawton', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Armitage', 'Affiliation': 'Psychology, University of Manchester, Manchester, Greater Manchester, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Meads', 'Affiliation': 'Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Schmitt', 'Affiliation': 'Academic Centre for Health Economics, University of York, York, UK.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Torgerson', 'Affiliation': 'Education, Durham University, Durham, Durham, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'West', 'Affiliation': 'Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Siddiqi', 'Affiliation': 'Institute of Health Sciences, University of York, York, North Yorkshire, UK.'}]",Tobacco control,['10.1136/tobaccocontrol-2018-054905']
1484,31609007,Tenofovir monotherapy versus tenofovir plus entecavir combination therapy in HBeAg-positive chronic hepatitis patients with partial virological response to entecavir.,"AIMS


The aim of this retrospective study was to compare the efficacy and safety of tenofovir disoproxil fumarate (TDF) monotherapy and TDF + entecavir (ETV) combination therapy for chronic hepatitis B (CHB) patients with the partial virological response (PVR) to ETV.
METHODS


CHB patients with PVR to ETV were switched to TDF monotherapy or TDF + ETV combination therapy. The primary efficacy outcome was a virological response (VR), and the secondary efficacy outcomes were hepatitis B e antigen (HBeAg) seroconversion and alanine aminotransferase (ALT) normalization. The primary safety outcomes were changes in serum creatinine and serum phosphorus levels.
RESULTS


A total of 143 patients were investigated, including 63 patients in the TDF monotherapy group and 80 patients in the TDF + ETV combination therapy group. Baseline demographics and clinical characteristics were comparable between groups. The median age of patients was 44.5 years, and 76.2% of them were male. The VR rate in TDF + ETV group was higher than that of the TDF group at 48 weeks (88.8% vs 71.4%; P = .009). At 48 weeks, the HBeAg seroconversion rate of TDF + ETV group was higher than that of the TDF group (30% vs 15.9%; P = .049). There was no significant difference in the proportion of patients with elevated ALT in the TDF group and TDF + ETV group at 48 weeks (9.5% vs 7.5%; P = .665). After adjusting the treatment regimen, serum creatinine levels increased slightly and serum phosphorus level decreased slightly in both groups.
CONCLUSIONS


TDF + ETV combination therapy for 48 weeks had a higher VR rate than TDF monotherapy in CHB patients with PVR to ETV.",2020,There was no significant difference in the proportion of patients with elevated ALT in the TDF group and TDF + ETV group at 48 weeks (9.5% vs 7.5%; P = .665).,"['CHB patients with PVR to ETV', 'The median age of patients was 44.5 years, and 76.2% of them were male', 'HBeAg-positive chronic hepatitis patients with partial virological response to entecavir', '143 patients were investigated, including 63 patients in the TDF monotherapy group and 80 patients in the TDF\u2009+\u2009ETV combination therapy group', 'chronic hepatitis B (CHB) patients with the partial virological response (PVR) to ETV']","['TDF monotherapy', 'TDF monotherapy or TDF\u2009+\u2009ETV combination therapy', 'combination therapy', 'Tenofovir monotherapy versus tenofovir plus entecavir combination therapy', 'tenofovir disoproxil fumarate (TDF) monotherapy and TDF\u2009+\u2009entecavir (ETV', 'TDF']","['virological response (VR), and the secondary efficacy outcomes were hepatitis B e antigen (HBeAg) seroconversion and alanine aminotransferase (ALT) normalization', 'efficacy and safety', 'serum creatinine levels', 'HBeAg seroconversion rate of TDF', 'proportion of patients with elevated ALT', 'VR rate', 'serum creatinine and serum phosphorus levels', 'serum phosphorus level']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0019167', 'cui_str': 'e Antigens'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0019189', 'cui_str': 'Hepatitis, Chronic'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0524909', 'cui_str': 'Chronic Hepatitis B Virus Infection'}]","[{'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}]","[{'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0019167', 'cui_str': 'e Antigens'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0600061', 'cui_str': 'Serum creatinine level - finding'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",143.0,0.0534823,There was no significant difference in the proportion of patients with elevated ALT in the TDF group and TDF + ETV group at 48 weeks (9.5% vs 7.5%; P = .665).,"[{'ForeName': 'Yong-Hong', 'Initials': 'YH', 'LastName': 'Wang', 'Affiliation': 'Center of Infectious Diseases, West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Center of Infectious Diseases, West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Dong-Mei', 'Initials': 'DM', 'LastName': 'Zhang', 'Affiliation': 'Center of Infectious Diseases, West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Dong-Bo', 'Initials': 'DB', 'LastName': 'Wu', 'Affiliation': 'Center of Infectious Diseases, West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Ya-Chao', 'Initials': 'YC', 'LastName': 'Tao', 'Affiliation': 'Center of Infectious Diseases, West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Meng-Lan', 'Initials': 'ML', 'LastName': 'Wang', 'Affiliation': 'Center of Infectious Diseases, West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'En-Qiang', 'Initials': 'EQ', 'LastName': 'Chen', 'Affiliation': 'Center of Infectious Diseases, West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': 'Center of Infectious Diseases, West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}]",Journal of medical virology,['10.1002/jmv.25608']
1485,30522405,Reducing ethnic inequalities in bowel screening participation in New Zealand: A randomised controlled trial of telephone follow-up for non-respondents.,,2019,"CONCLUSIONS


Active follow-up led to higher bowel screening participation in Māori and Pacific but not in Asian ethnicities and was more effective in high deprivation subjects.","['New Zealand', 'Māori, Pacific, and Asian ethnicity individuals who failed to return a bowel screening test kit within four weeks of it being posted', '3828 eligible individuals']","['telephone', 'telephone active follow-up service or a control group']","['bowel screening participation', 'Participation rates', 'overall participation rates']","[{'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",3828.0,0.147127,"CONCLUSIONS


Active follow-up led to higher bowel screening participation in Māori and Pacific but not in Asian ethnicities and was more effective in high deprivation subjects.","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Sandiford', 'Affiliation': '1 Auckland and Waitemata District Health Boards - Planning Funding and Outcomes, Auckland, New Zealand.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Buckley', 'Affiliation': '3 Surgical and Ambulatory Department, Waitemata District Health Board, Auckland, New Zealand.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Holdsworth', 'Affiliation': '1 Auckland and Waitemata District Health Boards - Planning Funding and Outcomes, Auckland, New Zealand.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Tozer', 'Affiliation': '3 Surgical and Ambulatory Department, Waitemata District Health Board, Auckland, New Zealand.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Scott', 'Affiliation': '4 Waikato District Health Board, Hamilton, New Zealand.'}]",Journal of medical screening,['10.1177/0969141318815719']
1486,30576441,Influence of ultra-low oxygen (2%) tension on in-vitro human embryo development.,"STUDY QUESTION


Is a reduction in the oxygen tension from 5 to 2% during extended culture from Day 3 onwards beneficial for human blastocyst development in vitro?
SUMMARY ANSWER


A reduction in oxygen concentration from 5 to 2% O2 after Day 3 did not improve embryo development, quality and utilization rate.
WHAT IS KNOWN ALREADY


The human embryo leaves the fallopian tube to reach the uterine cavity around Day 3-4 post-ovulation. As the oxygen concentration ranges from 5 to 7% in the fallopian tube and decreases to 2% in the uterus, reducing the oxygen tension during extended culture from Day 3 onwards seems more physiological. We aim to mimic the in-vivo environment during in-vitro embryo culture. Therefore, we compared the effect of extended culture performed at 5% (control arm) or 2% oxygen (O2; study arm) tension on blastocyst formation and quality.
STUDY DESIGN, SIZE, DURATION


Between December 2016 and September 2017, in two prospective studies, sibling embryos were randomized on Day 3 to either 5% O2 (control) or 2% O2 (study) for extended culture. In the control arms of both studies 1 and 2, the dishes with blastocyst medium were pre-equilibrated overnight in 5% O2, 6% CO2 and 89% N2 at 37°C. In the 2% study groups, the overnight pre-equilibration of blastocyst media was performed in either 2% O2 (study 1, 99 cycles) or 5% O2 (study 2, 126 cycles). The latter provides a gradual transition from 5 to 2% O2 environment for the study arm.
PARTICIPANTS/MATERIALS, SETTINGS, METHODS


Embryo culture until Day 3 was always performed in 5% O2; if at least four embryos of moderate to excellent quality were obtained on Day 3, the sibling embryos were randomized to either 5% O2 or 2% O2 for extended culture. The endpoints were embryo development and quality on Day 5/6 and the utilization rate (embryos transferred and cryopreserved). Statistical analysis was performed using the chi-square test, a P-value of <0.05 was considered significantly different.
MAIN RESULTS AND THE ROLE OF CHANCE


In study 1, 811 embryos were randomized on Day 3: 405 to the 2% O2 and 406 to the 5% O2 condition. No differences were observed in the blastulation rate (68.6 versus 71.9%; P = 0.319) and the proportion of good quality blastocysts on Day 5 (55.8 versus 55.2%; P = 0.888), nor in the utilization rate (53.1 versus 53.2%; P = 1.000). In study 2, 1144 embryos were randomized: 572 in each arm. Similarly, no significant difference was demonstrated in terms of the blastulation rate (63.6 versus 64.7%; P = 0.758), the proportion of good quality blastocysts (46.9 versus 48.8%; P = 0.554) or the utilization rate (49.8 versus 48.1%; P = 0.953).
LIMITATIONS, REASON FOR CAUTION


This study evaluated embryo development only until Day 5/6. The effect of oxidative stress on the developing embryo may only become evident at later stages (i.e. during implantation) and should therefore be studied in an RCT. The question also remains as to whether the switch to ultra-low oxygen tension from Day 4 onwards, when the embryo arrives in the uterus in vivo, would be preferential.
WIDER IMPLICATIONS OF THE FINDINGS


Based on the present study results, there is no benefit in lowering the oxygen tension from 5 to 2% from Day 3 onwards during extended human embryo culture.
STUDY FUNDING/COMPETING INTEREST(s)


No funding was received for this study and the authors have no conflicts of interest to declare.
TRIAL REGISTRATION NUMBER


N/A.",2019,"No differences were observed in the blastulation rate (68.6 versus 71.9%; P = 0.319) and the proportion of good quality blastocysts on Day 5 (55.8 versus 55.2%; P = 0.888), nor in the utilization rate (53.1 versus 53.2%; P = 1.000).","['811 embryos', '1144 embryos were randomized: 572 in each arm', 'Embryo culture until Day 3 was always performed in 5% O2; if at least four embryos of moderate to excellent quality were obtained on Day 3, the sibling embryos', 'Between December 2016 and September 2017, in two prospective studies, sibling embryos']",['ultra-low oxygen (2%) tension'],"['blastocyst formation and quality', 'oxygen concentration ranges', 'blastulation rate', 'embryo development and quality on Day 5/6 and the utilization rate (embryos transferred and cryopreserved', 'utilization rate', 'embryo development, quality and utilization rate', 'oxygen tension', 'proportion of good quality blastocysts', 'oxygen concentration']","[{'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0233494', 'cui_str': 'Tension (finding)'}]","[{'cui': 'C0005705', 'cui_str': 'Embryo stage 3 structure'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0428646', 'cui_str': 'Oxygen concentration (observable entity)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0013936', 'cui_str': 'Embryonic Development'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial (procedure)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}]",,0.0422398,"No differences were observed in the blastulation rate (68.6 versus 71.9%; P = 0.319) and the proportion of good quality blastocysts on Day 5 (55.8 versus 55.2%; P = 0.888), nor in the utilization rate (53.1 versus 53.2%; P = 1.000).","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'De Munck', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel, Laarbeeklaan 101, Brussels, Belgium.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Janssens', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel, Laarbeeklaan 101, Brussels, Belgium.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Segers', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel, Laarbeeklaan 101, Brussels, Belgium.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tournaye', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel, Laarbeeklaan 101, Brussels, Belgium.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Van de Velde', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel, Laarbeeklaan 101, Brussels, Belgium.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Verheyen', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel, Laarbeeklaan 101, Brussels, Belgium.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/dey370']
1487,30396100,"Comparison of the effects of modified pectoral nerve block and erector spinae plane block on postoperative opioid consumption and pain scores of patients after radical mastectomy surgery: A prospective, randomized, controlled trial.","STUDY OBJECTIVE


Breast cancer is the most common malignancy of women all over the world. In this study, we compared the effects of ultrasound-guided modified pectoral nerve (PECS) block and erector spinae plane (ESP) block on postoperative opioid consumption, pain scores, and intraoperative fentanyl need of patients undergoing unilateral modified radical mastectomy surgery.
DESIGN


Single-blinded, prospective, randomized, efficacy study.
SETTING


Tertiary university hospital, postoperative recovery room and surgical ward.
PATIENTS


Forty patients (ASA I-II) were allocated to two groups. After exclusion, 38 patients were included in the final analysis (18 patients in the PECS groups and 20 in the ESP group).
INTERVENTIONS


Modified pectoral nerve block was performed in the PECS group and erector spinae plane block was performed in the ESP group.
MEASUREMENTS


Postoperative tramadol consumption and pain scores were compared between the groups. Also, intraoperative fentanyl need was measured.
MAIN RESULTS


Postoperative tramadol consumption was 132.78 ± 22.44 mg in PECS group and 196 ± 27.03 mg in ESP group (p = 0.001). NRS scores at the 15th and 30th min were similar between the groups. However, median NRS scores were significantly lower in PECS group at the postoperative 60th min, 120th min, 12th hour and 24th hour (p = 0.024, p = 0.018, p = 0.021 and p = 0.011 respectively). Intraoperative fentanyl need was 75 mg in PECS group and 87.5 mg in ESP group. The difference was not statistically significant (p = 0.263).
CONCLUSION


Modified PECS block reduced postoperative tramadol consumption and pain scores more effectively than ESP block after radical mastectomy surgery.",2019,"However, median NRS scores were significantly lower in PECS group at the postoperative 60th min, 120th min, 12th hour and 24th ","['patients after radical mastectomy surgery', 'Forty patients (ASA I-II', 'patients undergoing unilateral modified radical mastectomy surgery', 'Tertiary university hospital, postoperative recovery room and surgical ward', '38 patients were included in the final analysis (18 patients in the PECS groups and 20 in the ESP group']","['Modified PECS block', 'ultrasound-guided modified pectoral nerve (PECS) block and erector spinae plane (ESP) block', 'modified pectoral nerve block and erector spinae plane block', 'PECS', 'ESP']","['median NRS scores', 'postoperative opioid consumption, pain scores', 'Postoperative tramadol consumption and pain scores', 'postoperative opioid consumption and pain scores', 'postoperative tramadol consumption and pain scores', 'NRS scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024884', 'cui_str': 'Mastectomy, Radical'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0024883', 'cui_str': 'Modified Mastectomy'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0015373', 'cui_str': 'Extrasensory Perception'}]","[{'cui': 'C4273496', 'cui_str': 'Modified PECS block'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205967', 'cui_str': 'Pectoral Nerves'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0015373', 'cui_str': 'Extrasensory Perception'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}]",38.0,0.114127,"However, median NRS scores were significantly lower in PECS group at the postoperative 60th min, 120th min, 12th hour and 24th ","[{'ForeName': 'Başak', 'Initials': 'B', 'LastName': 'Altıparmak', 'Affiliation': 'Muğla Sıtkı Koçman University, Department of Anesthesiology and Reanimation, Muğla, Turkey. Electronic address: basakugurlu@me.com.'}, {'ForeName': 'Melike', 'Initials': 'M', 'LastName': 'Korkmaz Toker', 'Affiliation': 'Muğla Sıtkı Koçman University Training and Research Hospital, Department of Anesthesiology and Reanimation, Muğla, Turkey.'}, {'ForeName': 'Ali İhsan', 'Initials': 'Aİ', 'LastName': 'Uysal', 'Affiliation': 'Muğla Sıtkı Koçman University Training and Research Hospital, Department of Anesthesiology and Reanimation, Muğla, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Turan', 'Affiliation': 'Muğla Sıtkı Koçman University, Department of Anesthesiology and Reanimation, Muğla, Turkey.'}, {'ForeName': 'Semra', 'Initials': 'S', 'LastName': 'Gümüş Demirbilek', 'Affiliation': 'Muğla Sıtkı Koçman University, Department of Anesthesiology and Reanimation, Muğla, Turkey.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2018.10.040']
1488,31664441,Effect of Weight Loss via Severe vs Moderate Energy Restriction on Lean Mass and Body Composition Among Postmenopausal Women With Obesity: The TEMPO Diet Randomized Clinical Trial.,"Importance


Severely energy-restricted diets are the most effective dietary obesity treatment. However, there are concerns regarding potential adverse effects on body composition.
Objective


To compare the long-term effects of weight loss via severe vs moderate energy restriction on lean mass and other aspects of body composition.
Design, Setting, and Participants


The Type of Energy Manipulation for Promoting Optimum Metabolic Health and Body Composition in Obesity (TEMPO) Diet Trial was a 12-month, single-center, randomized clinical trial. A total of 101 postmenopausal women, aged 45 to 65 years with body mass index (calculated as weight in kilograms divided by height in meters squared) from 30 to 40, who were at least 5 years after menopause, had fewer than 3 hours of structured physical activity per week, and lived in the Sydney metropolitan area of New South Wales, Australia, were recruited between March 2013 and July 2016. Data analysis was conducted between October 2018 and August 2019.
Intervention


Participants were randomized to either 12 months of moderate (25%-35%) energy restriction with a food-based diet (moderate intervention) or 4 months of severe (65%-75%) energy restriction with a total meal replacement diet followed by moderate energy restriction for an additional 8 months (severe intervention). Both interventions had a prescribed protein intake of 1.0 g/kg of actual body weight per day, and physical activity was encouraged but not supervised.
Main Outcomes and Measures


The primary outcome was whole-body lean mass at 12 months after commencement of intervention. Secondary outcomes were body weight, thigh muscle area and muscle function (strength), bone mineral density, and fat mass and distribution, measured at 0, 4, 6, and 12 months.
Results


A total of 101 postmenopausal women were recruited (mean [SD] age, 58.0 [4.2] years; mean [SD] weight, 90.8 [9.1] kg; mean [SD] body mass index, 34.4 [2.5]). Compared with the moderate group at 12 months, the severe group lost more weight (effect size, -6.6 kg; 95% CI, -8.2 to -5.1 kg), lost more whole-body lean mass (effect size, -1.2 kg; 95% CI, -2.0 to -0.4 kg), and lost more thigh muscle area (effect size, -4.2 cm2; 95% CI, -6.5 to -1.9 cm2). However, decreases in whole-body lean mass and thigh muscle area were proportional to total weight loss, and there was no difference in muscle (handgrip) strength between groups. Total hip bone mineral density (effect size, -0.017 g/cm2; 95% CI, -0.029 to -0.005 g/cm2), whole-body fat mass (effect size, -5.5 kg; 95% CI, -7.1 to -3.9 kg), abdominal subcutaneous adipose tissue (effect size, -1890 cm3; 95% CI, -2560 to -1219 cm3), and visceral adipose tissue (effect size, -1389 cm3; 95% CI, -1748 to -1030 cm3) loss were also greater for the severe group than for the moderate group at 12 months.
Conclusions and Relevance


Severe energy restriction had no greater adverse effect on relative whole-body lean mass or handgrip strength compared with moderate energy restriction and was associated with 2-fold greater weight and fat loss over 12 months. However, there was significantly greater loss of total hip bone mineral density with severe vs moderate energy restriction. Therefore, caution is necessary when implementing severe energy restriction in postmenopausal women, particularly those with osteopenia or osteoporosis.
Trial Registration


anzctr.org.au Identifier: 12612000651886.",2019,"Total hip bone mineral density (effect size, -0.017 g/cm2; 95% CI, -0.029 to -0.005 g/cm2), whole-body fat mass (effect size, -5.5 kg; 95% CI, -7.1 to -3.9 kg), abdominal subcutaneous adipose tissue (effect size, -1890 cm3; 95% CI, -2560 to -1219 cm3), and visceral adipose tissue (effect size, -1389 cm3; 95% CI, -1748 to -1030 cm3) loss were also greater for the severe group than for the moderate group at 12 months.
","['Postmenopausal Women With Obesity', 'postmenopausal women, particularly those with osteopenia or osteoporosis', '101 postmenopausal women were recruited (mean [SD] age, 58.0 [4.2] years', '101 postmenopausal women, aged 45 to 65 years with body mass index (calculated as weight in kilograms divided by height in meters squared) from 30 to 40, who were at least 5 years after menopause, had fewer than 3 hours of structured physical activity per week, and lived in the Sydney metropolitan area of New South Wales, Australia, were recruited between March 2013 and July 2016']","['Weight Loss via Severe vs Moderate Energy Restriction', 'moderate (25%-35%) energy restriction with a food-based diet (moderate intervention) or 4 months of severe (65%-75%) energy restriction with a total meal replacement diet followed by moderate energy restriction for an additional 8 months (severe intervention', 'weight loss via severe vs moderate energy restriction']","['Total hip bone mineral density', 'thigh muscle area', 'weight and fat loss', 'whole-body lean mass', 'visceral adipose tissue', 'total weight loss', 'Optimum Metabolic Health and Body Composition in Obesity (TEMPO', 'muscle (handgrip) strength', 'total hip bone mineral density', 'weight', 'abdominal subcutaneous adipose tissue', 'Lean Mass and Body Composition', 'body weight, thigh muscle area and muscle function (strength), bone mineral density, and fat mass and distribution, measured at 0, 4, 6, and 12 months']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517758', 'cui_str': 'Four point two'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}, {'cui': 'C0587113', 'cui_str': 'After menopause (qualifier value)'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0559897', 'cui_str': 'Diet followed (observable entity)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030786', 'cui_str': 'Hip Bone'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0039866', 'cui_str': 'Thigh'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0076084', 'cui_str': '2,2,6,6-tetramethyl-4-piperidine-N-oxide'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1563741', 'cui_str': 'Subcutaneous Fat, Abdominal'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0231484', 'cui_str': 'Muscular activity'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",101.0,0.155129,"Total hip bone mineral density (effect size, -0.017 g/cm2; 95% CI, -0.029 to -0.005 g/cm2), whole-body fat mass (effect size, -5.5 kg; 95% CI, -7.1 to -3.9 kg), abdominal subcutaneous adipose tissue (effect size, -1890 cm3; 95% CI, -2560 to -1219 cm3), and visceral adipose tissue (effect size, -1389 cm3; 95% CI, -1748 to -1030 cm3) loss were also greater for the severe group than for the moderate group at 12 months.
","[{'ForeName': 'Radhika V', 'Initials': 'RV', 'LastName': 'Seimon', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise, and Eating Disorders, Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Anthony L', 'Initials': 'AL', 'LastName': 'Wild-Taylor', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise, and Eating Disorders, Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Shelley E', 'Initials': 'SE', 'LastName': 'Keating', 'Affiliation': 'School of Human Movement and Nutrition Sciences, Centre for Research on Exercise, Physical Activity and Health, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'McClintock', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise, and Eating Disorders, Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Harper', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise, and Eating Disorders, Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Alice A', 'Initials': 'AA', 'LastName': 'Gibson', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise, and Eating Disorders, Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Johnson', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise, and Eating Disorders, Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Hamish A', 'Initials': 'HA', 'LastName': 'Fernando', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise, and Eating Disorders, Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Tania P', 'Initials': 'TP', 'LastName': 'Markovic', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise, and Eating Disorders, Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Jacqueline R', 'Initials': 'JR', 'LastName': 'Center', 'Affiliation': ""Bone Biology Program, Garvan Institute of Medical Research, St Vincent's Hospital Clinical School, University of New South Wales, Sydney, New South Wales, Australia.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Franklin', 'Affiliation': 'Metabolism and Obesity Services, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Peter Y', 'Initials': 'PY', 'LastName': 'Liu', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Harbor-University of California Los Angeles Medical Center and Los Angeles BioMedical Research Institute, Los Angeles.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Grieve', 'Affiliation': 'Sydney Translational Imaging Laboratory, Heart Research Institute, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Lagopoulos', 'Affiliation': 'Sunshine Coast Mind and Neuroscience-Thompson Institute, University of the Sunshine Coast, Queensland, Australia.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Caterson', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise, and Eating Disorders, Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Nuala M', 'Initials': 'NM', 'LastName': 'Byrne', 'Affiliation': 'School of Health Sciences, College of Health and Medicine, University of Tasmania, Launceston, Tasmania, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Sainsbury', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise, and Eating Disorders, Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.13733']
1489,30541745,FDA Approval Summary: (Daunorubicin and Cytarabine) Liposome for Injection for the Treatment of Adults with High-Risk Acute Myeloid Leukemia.,"On August 3, 2017, the FDA granted regular approval to Vyxeos (also known as CPX-351; Jazz Pharmaceuticals), a liposomal formulation of daunorubicin and cytarabine in a fixed combination, for the treatment of adults with newly diagnosed therapy-related acute myeloid leukemia (t-AML) or acute myeloid leukemia (AML) with myelodysplasia-related changes (AML-MRC). Approval was based on data from Study CLTR0310-301, a randomized, multicenter, open-label, active-controlled trial comparing Vyxeos with a standard combination of daunorubicin and cytarabine (""7+3"") in 309 patients 60-75 years of age with newly diagnosed t-AML or AML-MRC. Because of elemental copper concerns with the Vyxeos formulation, patients with Wilson disease were excluded from the study. Vyxeos demonstrated an improvement in overall survival (HR 0.69; 95% confidence interval, 0.52-0.90;  P  = 0.005) with an estimated median overall survival of 9.6 months compared with 5.9 months for the ""7+3"" control arm. The toxicity profile of Vyxeos was similar to that seen with standard ""7+3"" with the exception of more prolonged neutropenia and thrombocytopenia on the Vyxeos arm. Because the pharmacology of Vyxeos differs from that of other formulations of daunorubicin and cytarabine, labeling includes a warning against interchanging formulations during treatment. This is the first FDA-approved treatment specifically for patients with t-AML or AML-MRC.",2019,"Vyxeos demonstrated an improvement in overall survival (HR 0.69; 95% confidence interval, 0.52-0.90;  P  = 0.005) with an estimated median overall survival of 9.6 months compared with 5.9 months for the ""7+3"" control arm.","['patients with Wilson disease', 'adults with newly diagnosed therapy-related acute myeloid leukemia (t-AML) or acute myeloid leukemia (AML) with myelodysplasia-related changes (AML-MRC', 'Adults with High-Risk Acute Myeloid Leukemia', 'patients with t-AML or AML-MRC', '309 patients 60-75 years of age with newly diagnosed t-AML or AML-MRC']","['daunorubicin and cytarabine (""7+3', 'daunorubicin and cytarabine', 'Daunorubicin and Cytarabine) Liposome']","['toxicity profile of Vyxeos', 'prolonged neutropenia and thrombocytopenia', 'overall survival', 'median overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019202', 'cui_str': 'Pseudosclerosis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C2825139', 'cui_str': 'Acute myeloid leukemia without prior myelodysplastic syndrome'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C4520103', 'cui_str': 'Vyxeos'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",309.0,0.135395,"Vyxeos demonstrated an improvement in overall survival (HR 0.69; 95% confidence interval, 0.52-0.90;  P  = 0.005) with an estimated median overall survival of 9.6 months compared with 5.9 months for the ""7+3"" control arm.","[{'ForeName': 'Aviva C', 'Initials': 'AC', 'LastName': 'Krauss', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. aviva.krauss@fda.hhs.gov.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Manning', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Paresma', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Fu', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Kumar G', 'Initials': 'KG', 'LastName': 'Janoria', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Gerlie', 'Initials': 'G', 'LastName': 'Gieser', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Bateman', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Przepiorka', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Yuan Li', 'Initials': 'YL', 'LastName': 'Shen', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Stacy S', 'Initials': 'SS', 'LastName': 'Shord', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Sheth', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Anamitro', 'Initials': 'A', 'LastName': 'Banerjee', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Kirsten B', 'Initials': 'KB', 'LastName': 'Goldberg', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Ann T', 'Initials': 'AT', 'LastName': 'Farrell', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Gideon M', 'Initials': 'GM', 'LastName': 'Blumenthal', 'Affiliation': 'Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pazdur', 'Affiliation': 'Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-18-2990']
1490,27919029,Polymorphism of rs873308 near the transmembrane protein 57 gene is associated with serum lipid levels.,"SNP (single-nucleotide polymorphism) of rs10903129 near the TMEM (transmembrane protein) 57 locus has been associated with TC (total cholesterol) in a previous GWAS (genome-wide association study), but the association of TMEM57 rs873308 SNP and serum lipid levels has not been previously reported. The current study was undertaken to detect the association of the TMEM57 rs873308 SNP and several environmental factors with serum lipid profiles in the Han Chinese and Mulao populations. The genotypes of the TMEM57 rs873308 SNP in 865 individuals of Han Chinese and 902 participants of Mulao nationality were determined by PCR and RFLP (restriction-fragment-length polymorphism) combined with gel electrophoresis and then confirmed by direct sequencing. The T allele frequency of TMEM57 rs873308 SNP was not different between Han and Mulao (23.18% versus 25.72%, P>0.05), but different between males and females in the two ethnic groups (P<0.05). The T allele carriers had lower serum TC, Apo (apolipoprotein) B, HDL-C (high-density lipoprotein cholesterol) levels, ApoA1/ApoB ratio in Han; and lower TAG (triacylglycerol), LDL-C (low-density lipoprotein cholesterol), ApoA1 levels and the ApoA1/ApoB ratio and higher HDL-C levels in Mulao than the T allele non-carriers. There was also different association of the TMEM57 rs873308 SNP and serum lipid profiles between males and females in the both ethnic groups. Serum lipid parameters in the two ethnic groups were also associated with several environmental factors. The association of the TMEM57 rs873308 SNP and serum lipid levels was different in the Han Chinese and Mulao populations and between males and females in the both ethnic groups. There may be a sex-specific association of the TMEM57 rs873308 SNP and serum lipid levels in our study populations.",2014,"The T allele carriers had lower serum TC, Apo (apolipoprotein) B, HDL-C (high-density lipoprotein cholesterol) levels, ApoA1/ApoB ratio in Han; and lower TAG (triacylglycerol), LDL-C (low-density lipoprotein cholesterol), ApoA1 levels and the ApoA1/ApoB ratio and higher HDL-C levels in Mulao than the T allele non-carriers.","['Han Chinese and Mulao populations', '865 individuals of Han Chinese and 902 participants of Mulao nationality']","['TMEM57 rs873308 SNP', 'TMEM (transmembrane protein']","['TMEM57 rs873308 SNP and serum lipid profiles', 'Serum lipid parameters', 'TMEM57 rs873308 SNP and serum lipid levels', 'T allele frequency of TMEM57 rs873308 SNP', 'serum lipid levels', 'serum TC, Apo (apolipoprotein) B, HDL-C (high-density lipoprotein cholesterol) levels, ApoA1/ApoB ratio in Han; and lower TAG (triacylglycerol), LDL-C (low-density lipoprotein cholesterol), ApoA1 levels and the ApoA1/ApoB ratio and higher HDL-C levels']","[{'cui': 'C0641339', 'cui_str': 'HAN(II)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0027473', 'cui_str': 'Nationality'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1287373', 'cui_str': 'Finding of serum lipid levels (finding)'}, {'cui': 'C0017270', 'cui_str': 'Allele Frequency'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0641339', 'cui_str': 'HAN(II)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0037293', 'cui_str': 'Tag (morphologic abnormality)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",,0.0184921,"The T allele carriers had lower serum TC, Apo (apolipoprotein) B, HDL-C (high-density lipoprotein cholesterol) levels, ApoA1/ApoB ratio in Han; and lower TAG (triacylglycerol), LDL-C (low-density lipoprotein cholesterol), ApoA1 levels and the ApoA1/ApoB ratio and higher HDL-C levels in Mulao than the T allele non-carriers.","[{'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Guo', 'Affiliation': ""Department of Cardiology, Institute of Cardiovascular Diseases, the First Affiliated Hospital, Guangxi Medical University, 22 Shuangyong Road, Nanning 530021, Guangxi, People's Republic of China.""}, {'ForeName': 'Rui-Xing', 'Initials': 'RX', 'LastName': 'Yin', 'Affiliation': ""Department of Cardiology, Institute of Cardiovascular Diseases, the First Affiliated Hospital, Guangxi Medical University, 22 Shuangyong Road, Nanning 530021, Guangxi, People's Republic of China yinruixing@163.com.""}, {'ForeName': 'Quan-Zhen', 'Initials': 'QZ', 'LastName': 'Lin', 'Affiliation': ""Department of Cardiology, Institute of Cardiovascular Diseases, the First Affiliated Hospital, Guangxi Medical University, 22 Shuangyong Road, Nanning 530021, Guangxi, People's Republic of China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ""Department of Cardiology, Institute of Cardiovascular Diseases, the First Affiliated Hospital, Guangxi Medical University, 22 Shuangyong Road, Nanning 530021, Guangxi, People's Republic of China.""}, {'ForeName': 'Shao-Wen', 'Initials': 'SW', 'LastName': 'Shen', 'Affiliation': ""Department of Cardiology, Institute of Cardiovascular Diseases, the First Affiliated Hospital, Guangxi Medical University, 22 Shuangyong Road, Nanning 530021, Guangxi, People's Republic of China.""}, {'ForeName': 'Jia-Qi', 'Initials': 'JQ', 'LastName': 'Sun', 'Affiliation': ""Department of Cardiology, Institute of Cardiovascular Diseases, the First Affiliated Hospital, Guangxi Medical University, 22 Shuangyong Road, Nanning 530021, Guangxi, People's Republic of China.""}, {'ForeName': 'Guang-Yuan', 'Initials': 'GY', 'LastName': 'Shi', 'Affiliation': ""Department of Cardiology, Institute of Cardiovascular Diseases, the First Affiliated Hospital, Guangxi Medical University, 22 Shuangyong Road, Nanning 530021, Guangxi, People's Republic of China.""}, {'ForeName': 'Jin-Zhen', 'Initials': 'JZ', 'LastName': 'Wu', 'Affiliation': ""Department of Cardiology, Institute of Cardiovascular Diseases, the First Affiliated Hospital, Guangxi Medical University, 22 Shuangyong Road, Nanning 530021, Guangxi, People's Republic of China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Clinical Laboratory of the Affiliated Cancer Hospital, Guangxi Medical University, Nanning 530021, Guangxi, People's Republic of China.""}, {'ForeName': 'Yi-Ming', 'Initials': 'YM', 'LastName': 'Wang', 'Affiliation': ""College of Stomatology, Guangxi Medical University, 22 Shuangyong Road, Nanning 530021, Guangxi, People's Republic of China.""}]",Bioscience reports,[]
1491,31663855,Cost and Effectiveness of Blended Versus Standard Cognitive Behavioral Therapy for Outpatients With Depression in Routine Specialized Mental Health Care: Pilot Randomized Controlled Trial.,"BACKGROUND


Cognitive behavioral therapy (CBT) is an effective treatment, but access is often restricted due to costs and limited availability of trained therapists. Blending online and face-to-face CBT for depression might improve cost-effectiveness and treatment availability.
OBJECTIVE


This pilot study aimed to examine the costs and effectiveness of blended CBT compared with standard CBT for depressed patients in specialized mental health care to guide further research and development of blended CBT.
METHODS


Patients were randomly allocated to blended CBT (n=53) or standard CBT (n=49). Blended CBT consisted of 10 weekly face-to-face sessions and 9 Web-based sessions. Standard CBT consisted of 15 to 20 weekly face-to-face sessions. At baseline and 10, 20, and 30 weeks after start of treatment, self-assessed depression severity, quality-adjusted life-years (QALYs), and costs were measured. Clinicians, blinded to treatment allocation, assessed psychopathology at all time points. Data were analyzed using linear mixed models. Uncertainty intervals around cost and effect estimates were estimated with 5000 Monte Carlo simulations.
RESULTS


Blended CBT treatment duration was mean 19.0 (SD 12.6) weeks versus mean 33.2 (SD 23.0) weeks in standard CBT (P<.001). No significant differences were found between groups for depressive episodes (risk difference [RD] 0.06, 95% CI -0.05 to 0.19), response to treatment (RD 0.03, 95% CI -0.10 to 0.15), and QALYs (mean difference 0.01, 95% CI -0.03 to 0.04). Mean societal costs for blended CBT were €1183 higher than standard CBT. This difference was not significant (95% CI -399 to 2765). Blended CBT had a probability of being cost-effective compared with standard CBT of 0.02 per extra QALY and 0.37 for an additional treatment response, at a ceiling ratio of €25,000. For health care providers, mean costs for blended CBT were €176 lower than standard CBT. This difference was not significant (95% CI -659 to 343). At €0 per additional unit of effect, the probability of blended CBT being cost-effective compared with standard CBT was 0.75. The probability increased to 0.88 at a ceiling ratio of €5000 for an added treatment response, and to 0.85 at €10,000 per QALY gained. For avoiding new depressive episodes, blended CBT was deemed not cost-effective compared with standard CBT because the increase in costs was associated with negative effects.
CONCLUSIONS


This pilot study shows that blended CBT might be a promising way to engage depressed patients in specialized mental health care. Compared with standard CBT, blended CBT was not considered cost-effective from a societal perspective but had an acceptable probability of being cost-effective from the health care provider perspective. Results should be carefully interpreted due to the small sample size. Further research in larger replication studies focused on optimizing the clinical effects of blended CBT and its budget impact is warranted.
TRIAL REGISTRATION


Netherlands Trial Register NTR4650; https://www.trialregister.nl/trial/4408.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.1186/s12888-014-0290-z.",2019,No significant differences were found between groups for depressive episodes (risk difference [RD],"['Outpatients With Depression in Routine Specialized Mental Health Care', 'Patients', 'depressed patients in specialized mental health care']","['standard CBT', 'standard CBT, blended CBT', 'Cognitive behavioral therapy (CBT', 'Blended CBT', 'blended CBT', 'Blended Versus Standard Cognitive Behavioral Therapy']","['self-assessed depression severity, quality-adjusted life-years (QALYs), and costs', 'Mean societal costs', 'depressive episodes (risk difference [RD', 'probability of being cost-effective', 'Cost and Effectiveness']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",1183.0,0.107875,No significant differences were found between groups for depressive episodes (risk difference [RD],"[{'ForeName': 'Lisa Catharine', 'Initials': 'LC', 'LastName': 'Kooistra', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Clinical Psychology Section, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Jenneke Elize', 'Initials': 'JE', 'LastName': 'Wiersma', 'Affiliation': 'Department of Research and Innovation, GGZ in Geest/Amsterdam University Medical Center, VU University Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Ruwaard', 'Affiliation': 'Department of Research and Innovation, GGZ in Geest/Amsterdam University Medical Center, VU University Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Neijenhuijs', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Clinical Psychology Section, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Joran', 'Initials': 'J', 'LastName': 'Lokkerbol', 'Affiliation': 'Center of Economic Evaluation, Trimbos Institute (Netherlands Institute of Mental Health and Addiction), Utrecht, Netherlands.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'van Oppen', 'Affiliation': 'Department of Research and Innovation, GGZ in Geest/Amsterdam University Medical Center, VU University Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Smit', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Clinical Psychology Section, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Heleen', 'Initials': 'H', 'LastName': 'Riper', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Clinical Psychology Section, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}]",Journal of medical Internet research,['10.2196/14261']
1492,31656059,Biomarker-guided management reduces exacerbations in non-eosinophilic asthma in pregnancy: A secondary analysis of a randomized controlled trial.,"BACKGROUND AND OBJECTIVE


The aim of this secondary analysis of a randomized controlled trial (RCT) of asthma management in pregnancy was to determine the treatment decision differences between a symptom control algorithm and a fractional exhaled nitric oxide (FENO)-guided algorithm, and whether the approach was effective in non-eosinophilic asthma (NEA).
METHODS


In this double-blind parallel group RCT, women with asthma were randomized prior to 22 weeks gestation to treatment adjustment according to a symptom control algorithm (control group), or a FENO-guided algorithm (inhaled corticosteroid (ICS) dose adjusted according to FENO with long-acting beta-agonist (LABA) added for uncontrolled symptoms). NEA was classified as baseline blood eosinophils <0.26 × 10 9  /L and FENO ≤29 ppb. Exacerbations requiring medical intervention were recorded.
RESULTS


Among 220 non-smokers (n = 109 control, n = 111 FENO), 1006 treatment decisions were made, with significant group differences after the first and second algorithm applications. 53% of women had NEA. Treatment was better targeted to phenotype in the FENO group: ICS use increased in eosinophilic asthma (EA, 48-86%), while ICS/LABA increased in NEA (11-30%). Fewer women in the FENO group had exacerbations during pregnancy in NEA only (18.9% FENO vs 44% control, P = 0.006).
CONCLUSION


The FENO algorithm was more effective in treating NEA, resulting in reduced exacerbations, compared to a symptom control algorithm. This was not the result of ICS overtreatment, since the benefits occurred at a lower median daily ICS dose. Two applications of the FENO-guided algorithm, one month apart, were sufficient to achieve beneficial effects in terms of asthma exacerbations, among pregnant women with asthma.",2020,"The FENO algorithm was more effective in treating NEA, resulting in reduced exacerbations, compared to a symptom control algorithm.","['non-eosinophilic asthma in pregnancy', 'women with asthma', 'pregnant women with asthma']","['symptom control algorithm (control group), or a FENO-guided algorithm (inhaled corticosteroid (ICS) dose adjusted according to FENO with long-acting beta-agonist (LABA', 'Biomarker-guided management', 'FENO']","['ICS/LABA increased in NEA', 'eosinophilic asthma', 'exacerbations during pregnancy in NEA']","[{'cui': 'C0034068', 'cui_str': 'Pulmonary Eosinophilia'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}]","[{'cui': 'C1274136', 'cui_str': 'Symptom control'}, {'cui': 'C0002045'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]","[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0034068', 'cui_str': 'Pulmonary Eosinophilia'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]",1006.0,0.40201,"The FENO algorithm was more effective in treating NEA, resulting in reduced exacerbations, compared to a symptom control algorithm.","[{'ForeName': 'Vanessa E', 'Initials': 'VE', 'LastName': 'Murphy', 'Affiliation': 'Priority Research Centre GrowUpWell and Hunter Medical Research Institute, Faculty of Health and Medicine, The University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Celeste M', 'Initials': 'CM', 'LastName': 'Porsbjerg', 'Affiliation': 'Respiratory Research Unit, Department of Respiratory Medicine, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Annelies L', 'Initials': 'AL', 'LastName': 'Robijn', 'Affiliation': 'Priority Research Centre GrowUpWell and Hunter Medical Research Institute, Faculty of Health and Medicine, The University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Gibson', 'Affiliation': 'Priority Research Centre for Healthy Lungs and Hunter Medical Research Institute, Faculty of Health and Medicine, The University of Newcastle, Callaghan, NSW, Australia.'}]","Respirology (Carlton, Vic.)",['10.1111/resp.13713']
1493,29693650,A randomized trial to study the comparative efficacy of phenylbutyrate and benzoate on nitrogen excretion and ureagenesis in healthy volunteers.,"PURPOSE


Benzoate and phenylbutyrate are widely used in the treatment of urea cycle disorders, but detailed studies on pharmacokinetics and comparative efficacy on nitrogen excretion are lacking.
METHODS


We conducted a randomized, three-arm, crossover trial in healthy volunteers to study pharmacokinetics and comparative efficacy of phenylbutyrate (NaPB; 7.15 g•m -2 BSA•day -1 ), benzoate (NaBz; 5.5 g•m -2 BSA•day -1 ), and a combination of two medications (MIX arm; 3.575 g NaPB and 2.75 g NaBz•m -2 BSA•day -1 ) on nitrogen excretion. Stable isotopes were used to study effects on urea production and dietary nitrogen disposal.
RESULTS


The conjugation efficacy for both phenylbutyrate and benzoate was 65%; conjugation was superior at the lower dose used in the MIX arm. Whereas NaPB and MIX treatments were more effective at excreting nitrogen than NaBz, nitrogen excretion as a drug conjugate was similar between phenylbutyrate and MIX arms. Nitrogen excreted per USD was higher with combination therapy compared with NaPB.
CONCLUSION


Phenylbutyrate was more effective than benzoate at disposing nitrogen. Increasing phenylbutyrate dose may not result in higher nitrogen excretion due to decreased conjugation efficiency at higher doses. Combinatorial therapy with phenylbutyrate and benzoate has the potential to significantly decrease treatment cost without compromising the nitrogen disposal efficacy.",2018,The conjugation efficacy for both phenylbutyrate and benzoate was 65%; conjugation was superior at the lower dose used in the MIX arm.,['healthy volunteers'],['phenylbutyrate and benzoate'],"['NaBz, nitrogen excretion', 'conjugation efficacy', 'Nitrogen excreted per USD', 'nitrogen excretion', 'urea production and dietary nitrogen disposal', 'nitrogen excretion and ureagenesis']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0031465', 'cui_str': 'Phenylbutyrates'}, {'cui': 'C0005058', 'cui_str': 'Benzoates'}]","[{'cui': 'C0028158', 'cui_str': 'Nitrogen'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0070525', 'cui_str': 'phenacemide'}, {'cui': 'C0033268'}]",,0.0170516,The conjugation efficacy for both phenylbutyrate and benzoate was 65%; conjugation was superior at the lower dose used in the MIX arm.,"[{'ForeName': 'Sandesh C S', 'Initials': 'SCS', 'LastName': 'Nagamani', 'Affiliation': 'Department of Molecular and Human Genetics, Baylor College of Medicine, Houston, USA, Texas.'}, {'ForeName': 'Umang', 'Initials': 'U', 'LastName': 'Agarwal', 'Affiliation': ""USDA/Agricultural Research Service, Children's Nutrition Research Center, Houston, USA, Texas.""}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Tam', 'Affiliation': 'Department of Molecular and Human Genetics, Baylor College of Medicine, Houston, USA, Texas.'}, {'ForeName': 'Mahshid', 'Initials': 'M', 'LastName': 'Azamian', 'Affiliation': 'Department of Molecular and Human Genetics, Baylor College of Medicine, Houston, USA, Texas.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'McMeans', 'Affiliation': ""Texas Children's Hospital, Houston, USA, Texas.""}, {'ForeName': 'Inka C', 'Initials': 'IC', 'LastName': 'Didelija', 'Affiliation': ""USDA/Agricultural Research Service, Children's Nutrition Research Center, Houston, USA, Texas.""}, {'ForeName': 'Mahmoud A', 'Initials': 'MA', 'LastName': 'Mohammad', 'Affiliation': ""USDA/Agricultural Research Service, Children's Nutrition Research Center, Houston, USA, Texas.""}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Marini', 'Affiliation': ""USDA/Agricultural Research Service, Children's Nutrition Research Center, Houston, USA, Texas. marini@bcm.edu.""}]",Genetics in medicine : official journal of the American College of Medical Genetics,['10.1038/gim.2017.167']
1494,30325237,A pilot study using electronic reminders for amblyopia treatment.,"Treatment compliance is the most important factor for predicting a successful outcome in amblyopia treatment. Electronic applications have been successfully employed in other medical conditions in an effort to improve compliance. Aim : To determine whether a smartphone medical adherence application (app) (RxmindMe® Prescription/Medicine Reminder and Pill Tracker) may be successfully incorporated into the treatment plan of patients 3-7 years of age who have not previously been treated for amblyopia. Methods : Children 3-7 years of age were randomized to receive electronic reminders (reminders group) or standard instructions (control group). Visual acuity and compliance with treatment was assessed at the first follow-up visit. The child's adherence with the prescribed treatment was calculated as the reported number of hours of patching performed divided by the number of hours prescribed or compliance percentage. The validated ""Amblyopia Treatment Index Parental Questionnaire"" was administered to the parent/guardian to assess any differences in the compliance subscale between the two treatment groups. Any difficulties encountered with the use of the reminder app were also recorded at the follow-up visit. Results : Twenty-four participants were enrolled. Twelve participants in the reminder group (eight female, four male; mean age 4.5 ± 1.3) were compared with 12 participants in the control group (five female, seven male; mean 4.8 ± 1.1). No significant differences were found between the two groups in terms of age ( p  = 0.62), gender ( p  = 0.22), or degree of amblyopia at the start of treatment ( p  = 0.99). Eleven of 12 participants in the reminders group were able to incorporate the reminder app into amblyopia treatment. No participant reported malfunction of the alarm portion of the reminder app. There was no significant difference seen in degree of visual acuity improvement, reported percentage compliance or effect on the compliance subscale as assessed by the ATI questionnaire. Several participants reported the app to be ""helpful"" in initiating treatment. Conclusion : Our findings indicate that use of a smartphone app is feasible in this patient population. Targeting the app to specific patient demographics or when difficulty with compliance is encountered needs to be further investigated.",2018,"There was no significant difference seen in degree of visual acuity improvement, reported percentage compliance or effect on the compliance subscale as assessed by the ATI questionnaire.","['3-7\xa0years of age', 'Twelve participants in the reminder group (eight female, four male; mean age 4.5\xa0±\xa01.3) were compared with 12 participants in the control group (five female, seven male; mean 4.8\xa0±\xa01.1', 'patients 3-7\xa0years of age who have not previously been treated for amblyopia', 'Children', 'Twenty-four participants were enrolled']","['electronic reminders', 'smartphone medical adherence application (app) (RxmindMe® Prescription/Medicine Reminder and Pill Tracker', 'electronic reminders (reminders group) or standard instructions (control group']","['validated ""Amblyopia Treatment Index Parental Questionnaire', 'degree of amblyopia', 'degree of visual acuity improvement', 'Visual acuity and compliance', 'compliance subscale']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C4517765', 'cui_str': '4.8 (qualifier value)'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",24.0,0.0260685,"There was no significant difference seen in degree of visual acuity improvement, reported percentage compliance or effect on the compliance subscale as assessed by the ATI questionnaire.","[{'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Vagge', 'Affiliation': 'Department of Pediatric Ophthalmology, Wills Eye Hospital, Philadelphia, PA, USA.'}, {'ForeName': 'Kammi B', 'Initials': 'KB', 'LastName': 'Gunton', 'Affiliation': 'Department of Pediatric Ophthalmology, Wills Eye Hospital, Philadelphia, PA, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Schnall', 'Affiliation': 'Department of Pediatric Ophthalmology, Wills Eye Hospital, Philadelphia, PA, USA.'}]",Strabismus,['10.1080/09273972.2018.1526959']
1495,32409111,Melatonin and melatonin agonists as treatments for benzodiazepines and hypnotics withdrawal in patients with primary insomnia. A systematic review.,"BACKGROUND


Hypnotics (HYP) and benzodiazepines (BZD) are medicines prescribed for the insomnia treatment. Many patients present difficulties in discontinuing the treatment once established. Melatonin (MLT) has been prescribed as a treatment for BZD/HYP detoxification.
AIMS


The primary objective of this systematic review is to assess the efficacy of MLT and MLT agonists (melatoninergics) in improving the rate of BZD and/or HYP discontinuation among adults with primary insomnia attempting to discontinue BZD and/or HYP. The secondary objective is to evaluate the partial efficacy of melatoninergic drugs in the discontinuation of BZD and/or HYP consumption in subjects that could not stop their consumption.
METHOD


A search on Web of Science and Scopus was carried out from database inception to July 1st, 2019.
RESULTS


Three hundred and forty-nine articles were identified but only four were included in the final review. Two were cohort prospective, one placebo-control double blind and one double blind placebo-control cross-over designed study. Total withdrawal (TW) ranged from 0% to 25% in the placebo arm and from 64.3% to 77.8% in the MLT arm. In cohort studies TW figures ranged from 30.8% to 65%. Partial withdrawal ranged between 20% and 30.8% of patients that did not achieve TW with reduction figures of diazepam equivalent dose ranging from 25% to 75%.
CONCLUSION


MLT has a place in the physician armamentarium to treat the suspension/reduction of BZD/HYP consumption in patients with primary insomnia.",2020,Total withdrawal (TW) ranged from 0% to 25% in the placebo arm and from 64.3% to 77.8% in the MLT arm.,"['patients with primary insomnia', 'Three hundred and forty-nine articles were identified but only four were included in the final review', 'adults with primary insomnia attempting to discontinue BZD and/or HYP', 'subjects that could not stop their consumption']","['MLT and MLT agonists (melatoninergics', 'placebo-control double blind and one double blind placebo-control cross', 'MLT', 'Melatonin and melatonin agonists', 'diazepam', 'Melatonin (MLT', 'benzodiazepines', 'Hypnotics (HYP) and benzodiazepines (BZD', 'placebo']","['rate of BZD and/or HYP discontinuation', 'Total withdrawal (TW', 'Partial withdrawal ranged']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033139', 'cui_str': 'Primary insomnia'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0020591', 'cui_str': 'Hypnotic agent'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C1635027', 'cui_str': 'Melatonin agonist'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0012010', 'cui_str': 'Diazepam'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0020591', 'cui_str': 'Hypnotic agent'}]","[{'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0020591', 'cui_str': 'Hypnotic agent'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",349.0,0.110412,Total withdrawal (TW) ranged from 0% to 25% in the placebo arm and from 64.3% to 77.8% in the MLT arm.,"[{'ForeName': 'Armando L', 'Initials': 'AL', 'LastName': 'Morera-Fumero', 'Affiliation': 'Departamento de Medicina Interna, Dermatología y Psiquiatría. Facultad de Ciencias de la Salud, Universidad de La Laguna, La Laguna, Santa Cruz de Tenerife, Spain; Consultoría Psiquiátrica SC, Santa Cruz de Tenerife, Spain. Electronic address: amorera@ull.edu.es.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Fernandez-Lopez', 'Affiliation': 'Departamento de Medicina Interna, Dermatología y Psiquiatría. Facultad de Ciencias de la Salud, Universidad de La Laguna, La Laguna, Santa Cruz de Tenerife, Spain; Sociedad para la Investigación y Asistencia en Salud Mental, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Abreu-Gonzalez', 'Affiliation': 'Departamento de Ciencias Médicas Básicas: Unidad de Fisiología. Facultad de Ciencias de la Salud. Universidad de la Laguna, la Laguna, Santa Cruz de Tenerife, Spain.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.107994']
1496,31863497,A Two-way Street: Mentor Stress and Depression Influence Relational Satisfaction and Attachment in Youth Mentoring Relationships.,"Over the past two decades, youth mentoring programs have increased in popularity as an intervention for children exposed to a range of stressful life circumstances. Such programs have been shown to promote positive youth development and reduce risk for emotional and behavioral problems; yet, the effect size of youth gains remains small. The current study examined the influence of college student mentors' history of early life stress and baseline depressive symptoms on their effectiveness in youth mentoring relationships using 340 randomized mentor-youth pairs from College Mentors for Kids, a well-established mentoring program with chapters across the United States. Hierarchical linear models revealed that mentors with higher levels of depressive symptoms reported lower relationship satisfaction and increased avoidance in the mentoring relationship. In contrast, mentors who experienced higher levels of early life stress had youth who reported greater satisfaction in the mentoring relationship and decreased relational anxiety. These findings are some of the first to examine the impact of mentor characteristics on mentor-youth relationships and highlight the importance of considering factors relevant to psychosocial functioning and emotional distress when recruiting, training, and supporting college student mentors.",2020,Hierarchical linear models revealed that mentors with higher levels of depressive symptoms reported lower relationship satisfaction and increased avoidance in the mentoring relationship.,"['youth mentoring relationships using 340 randomized mentor-youth pairs from College Mentors for Kids, a well-established mentoring program with chapters across the United States', 'Youth Mentoring Relationships']",[],['relational anxiety'],"[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C4255266', 'cui_str': 'Mentoring'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}]",340.0,0.05768,Hierarchical linear models revealed that mentors with higher levels of depressive symptoms reported lower relationship satisfaction and increased avoidance in the mentoring relationship.,"[{'ForeName': 'Emma G', 'Initials': 'EG', 'LastName': 'Preston', 'Affiliation': 'Department of Psychological Sciences, William & Mary, Williamsburg, VA, USA.'}, {'ForeName': 'Elizabeth B', 'Initials': 'EB', 'LastName': 'Raposa', 'Affiliation': 'Department of Psychological Sciences, William & Mary, Williamsburg, VA, USA.'}]",American journal of community psychology,['10.1002/ajcp.12412']
1497,30450545,The Effect of Beginning Treatment With Fremanezumab on Headache and Associated Symptoms in the Randomized Phase 2 Study of High Frequency Episodic Migraine: Post-Hoc Analyses on the First 3 Weeks of Treatment.,"BACKGROUND


Migraine has a substantial impact on daily living, affecting productivity and quality of life for patients and their families. Patients frequently discontinue preventive medications in part because of a delay in headache and symptom relief due to the long dose titration procedures necessary for some migraine preventives.
OBJECTIVE


To evaluate the efficacy of fremanezumab, a selective monoclonal CGRP ligand antibody, during the first 3 weeks of therapy in patients with high-frequency episodic migraine (HFEM) to relieve migraine headaches and associated symptoms and to reduce use of acute migraine medications.
METHODS


In a multicenter, randomized, double-blind, placebo-controlled, phase 2 study, patients with HFEM who met inclusion criteria and were 80% compliant with daily headache diary entry were randomized and treated once every 28 days for 3 months with either placebo or fremanezumab 225 or 675 mg. Compared to placebo, both doses of fremanezumab significantly reduced the primary endpoint of the HFEM study, change in the number of migraine days in month 3 relative to baseline. Herein, we performed post-hoc analyses to assess the efficacy of each dose during the first 3 weeks of treatment to reduce migraine headache parameters, associated migraine symptoms, and the consumption of acute migraine medications.
RESULTS


The sample consisted of 297 study participants. Compared to placebo, decreases in migraine days were seen during the first week of therapy for both fremanezumab doses with least square mean (LSM) differences between fremanezumab 225 mg and placebo of -0.93 (95% CI: -1.36, -0.49) and between 675 mg dose and placebo of -1.02 (95% CI: -1.46, -0.58), both P < .0001. This benefit was maintained through the second week of therapy for the 225 and 675 mg doses, respectively, (-0.76 (95% CI: -1.11, -0.40) P < .0001, -.79 (95% CI: -1.15, -0.44) P < .0001) and the third week of therapy (-0.64 (95% CI: -0.97, -0.30) P = .0003 and -0.64 (95% CI: -0.98, -0.30) P = .0003). Likewise in the first week, patients recorded reductions in associated migraine symptoms such as nausea, vomiting, photophobia, and phonophobia, which continued through weeks 2 and 3. There were also reductions in days with acute medication use to treat migraine for the 225 and 675 mg fremanezumab doses compared to placebo. In the first week, LSM differences between 225 mg and placebo were -1.02 (95% CI: -1.39, -0.64) and between 675 mg and placebo were -1.06 (95% CI: -1.39, -0.64) P < .0001); for the second and third weeks (-1.01 (95% CI: -1.14, -0.55) P < .0001; -.90 (95% CI: -1.04, -0.44) P < .0001; -.91 (95% CI: -0.92, -0.34) P < .0001; and -.83 (95% CI: -0.84, -0.26) P = .0002), respectively.
CONCLUSION


Fremanezumab treatment resulted in a rapid preventive response in patients with HFEM, with reductions seen in several headache parameters and migraine symptoms within the first week after therapy initiation and continuing during the second and third weeks. Patients also were able to rapidly reduce their use of acute medications to treat migraine attacks. The trial is registered at Clinicaltrials.gov as NCT02025556.",2019,"Compared to placebo, decreases in migraine days were seen during the first week of therapy for both fremanezumab doses with least square mean (LSM) differences between fremanezumab 225 mg and placebo of -0.93","['patients with HFEM', 'patients with high-frequency episodic migraine (HFEM', 'patients with HFEM who met inclusion criteria and were 80% compliant with daily headache diary entry', '297 study participants']","['fremanezumab', 'placebo or fremanezumab 225 or 675\xa0mg', 'Fremanezumab', 'placebo']","['migraine days', 'rapid preventive response', 'headache and symptom relief', 'number of migraine days', 'several headache parameters and migraine symptoms', 'migraine headache parameters, associated migraine symptoms', 'migraine symptoms such as nausea, vomiting, photophobia, and phonophobia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0051533', 'cui_str': 'Am 80'}, {'cui': 'C0566588', 'cui_str': 'Compliant (qualifier value)'}, {'cui': 'C3661947', 'cui_str': 'Daily headache'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C4549503', 'cui_str': 'fremanezumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C4517854', 'cui_str': '675 (qualifier value)'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0085636', 'cui_str': 'Light Sensitivity'}, {'cui': 'C0751466', 'cui_str': 'Phonophobia'}]",297.0,0.344157,"Compared to placebo, decreases in migraine days were seen during the first week of therapy for both fremanezumab doses with least square mean (LSM) differences between fremanezumab 225 mg and placebo of -0.93","[{'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Silberstein', 'Affiliation': 'Jefferson Headache Center, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Rapoport', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Pippa S', 'Initials': 'PS', 'LastName': 'Loupe', 'Affiliation': 'Global Research and Development Teva Pharmaceuticals Ltd, Overland Park, KS, USA.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Aycardi', 'Affiliation': 'Xenon Pharmaceuticals Inc, Boston, MA, USA.'}, {'ForeName': 'Mirna', 'Initials': 'M', 'LastName': 'McDonald', 'Affiliation': 'Global Research and Development Teva Pharmaceuticals Ltd, West Chester, PA, USA.'}, {'ForeName': 'Ronghua', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Global Research and Development Teva Pharmaceuticals Ltd, West Chester, PA, USA.'}, {'ForeName': 'Marcelo E', 'Initials': 'ME', 'LastName': 'Bigal', 'Affiliation': 'Purdue Pharma, Stamford, CT, USA.'}]",Headache,['10.1111/head.13446']
1498,31175807,"Low-Fat Dietary Pattern among Postmenopausal Women Influences Long-Term Cancer, Cardiovascular Disease, and Diabetes Outcomes.","BACKGROUND


The preferred macronutrient dietary composition, and the health consequences of dietary fat reduction specifically, have been debated for decades. Here we provide a comprehensive overview of long-term health outcomes in the Women's Health Initiative Dietary Modification (DM) trial.
OBJECTIVE


The DM trial aimed to examine whether a low-fat dietary pattern would reduce the risk of invasive breast cancer, colorectal cancer, and, secondarily, coronary heart disease (CHD), with various other health outcomes also considered.
METHODS


The DM trial is a randomized controlled trial conducted at 40 centers in the US, among 48,835 postmenopausal women aged 50-79 y with baseline intake of ≥32% energy from fat. Participants were randomly assigned to a low-fat dietary pattern intervention group or to a usual-diet comparison group, during 1993-1998. Intervention goals were to reduce fat intake from ∼35% to 20% of total energy, in conjunction with increasing vegetables and fruit to 5 servings/d and grains to 6 servings/d.
RESULTS


Over an 8.5-y (median) intervention period, intervention and comparison group differences included lower fat by 8-10%, and higher carbohydrate by 8-10%, of total energy, in conjunction with higher consumption of vegetables, fruit, and grains. Time-to-outcome analyses did not show significant differences between intervention and comparison groups for invasive breast cancer, colorectal cancer, or CHD, either over the intervention period or over longer-term cumulative follow-up. Additional analyses showed significant intervention group benefits related to breast cancer, CHD, and diabetes, without adverse effects. Over a 19.6-y (median) follow-up period, HRs (95% CIs) were 0.84 (0.74, 0.96) for breast cancer followed by death, and 0.87 (0.77, 0.98) for diabetes requiring insulin.
CONCLUSIONS


Reduction in dietary fat with corresponding increase in vegetables, fruit, and grains led to benefits related to breast cancer, CHD, and diabetes, without adverse effects, among healthy postmenopausal US women.
This trial was registered at clinicaltrials.gov as NCT00000611.",2019,"Time-to-outcome analyses did not show significant differences between intervention and comparison groups for invasive breast cancer, colorectal cancer, or CHD, either over the intervention period or over longer-term cumulative follow-up.","['40 centers in the US, among 48,835 postmenopausal women aged 50-79 y with baseline intake of ≥32% energy from fat', ""Women's Health Initiative Dietary Modification (DM) trial"", 'healthy postmenopausal US women']",['low-fat dietary pattern intervention group or to a usual-diet comparison'],"['breast cancer, CHD, and diabetes, without adverse effects', 'invasive breast cancer, colorectal cancer, or CHD', 'risk of invasive breast cancer, colorectal cancer, and, secondarily, coronary heart disease (CHD']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0080339', 'cui_str': 'Womens Health'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}, {'cui': 'C0086153', 'cui_str': 'Dietary Modification'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}]",48835.0,0.112797,"Time-to-outcome analyses did not show significant differences between intervention and comparison groups for invasive breast cancer, colorectal cancer, or CHD, either over the intervention period or over longer-term cumulative follow-up.","[{'ForeName': 'Ross L', 'Initials': 'RL', 'LastName': 'Prentice', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Aaron K', 'Initials': 'AK', 'LastName': 'Aragaki', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Barbara V', 'Initials': 'BV', 'LastName': 'Howard', 'Affiliation': 'Department of Medicine, Georgetown University Medical Center, and MedStar Health Research Institute, Hyattsville, MD, USA.'}, {'ForeName': 'Rowan T', 'Initials': 'RT', 'LastName': 'Chlebowski', 'Affiliation': 'Oncology/Hematology, Division of Medicine, Los Angeles Biomedical Research Institute, Torrance, CA, USA.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Thomson', 'Affiliation': 'College of Public Health, Department of Nutritional Sciences, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Van Horn', 'Affiliation': 'Department of Preventive Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Lesley F', 'Initials': 'LF', 'LastName': 'Tinker', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Garnet L', 'Initials': 'GL', 'LastName': 'Anderson', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Lewis E', 'Initials': 'LE', 'LastName': 'Kuller', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Marian L', 'Initials': 'ML', 'LastName': 'Neuhouser', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Sciences Center, Memphis, TN, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Snetselaar', 'Affiliation': 'Preventive Nutrition Education, Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Jacques E', 'Initials': 'JE', 'LastName': 'Rossouw', 'Affiliation': 'National Heart, Lung, and Blood Institute, Bethesda, MD, USA.'}]",The Journal of nutrition,['10.1093/jn/nxz107']
1499,31655189,Controlled-Release Oxycodone vs. Placebo in the Treatment of Chronic Breathlessness-A Multisite Randomized Placebo Controlled Trial.,"CONTEXT


Chronic breathlessness is a clinical syndrome that results in significant distress and disability. Morphine can reduce chronic breathlessness when the contributing etiologies are optimally treated.
OBJECTIVES


Does oxycodone reduce chronic breathlessness compared with placebo?
METHODS


A multisite, randomized, placebo-controlled, double-blind, parallel-arm, fixed-dose trial of oral controlled-release oxycodone 15 mg (5 mg, eight hourly) or placebo (ACTRN12609000806268 at www.anzctr.org.au). As-needed immediate-release morphine (2.5 mg per dose; six and less doses/day) was available for both arms as required by one ethics committee overseeing the trial. Recruitment occurred from 2010 to 2014 in 14 inpatient and outpatient respiratory, cardiology, and palliative care services across Australia. Participants were adults, with chronic breathlessness (modified Medical Research Council Scale 3 or 4), who were opioid naive. The primary end point was the proportion of people with greater than 15% reduction from baseline in the intensity of breathlessness now (0-100 mm visual analogue scale) comparing arms Days 5-7. Secondary end points were average and worst breathlessness, quality of life, function, and harms.
RESULTS


Of 157 participants randomized, 155 were included (74 oxycodone and 81 placebo), but the study did not reach target recruitment. There was difference in neither between groups for the primary outcome (P = 0.489) nor any of the prespecified secondary outcomes. Placebo participants used more as-needed morphine (mean 7.0 vs. 4.2 doses; P ≤ 0.001). Oxycodone participants reported more nausea (P < 0.001).
CONCLUSION


There was no signal of benefit from oxycodone over placebo. Future research should focus on investigating the existence of an opioid class effect on the reduction of chronic breathlessness.",2020,Placebo participants used more 'as needed' morphine (mean 7.0 versus 4.2 doses; p≤0.001).,"['2010 to 2014 in 14 inpatient and outpatient respiratory, cardiology and palliative care services across Australia', 'chronic breathlessness ', '157 participants randomised', 'Participants were adults, with chronic breathlessness (modified Medical Research Council Scale 3 or 4), who were opioid naïve']","['morphine', 'Placebo', 'oxycodone versus placebo', 'oral controlled-release oxycodone', 'placebo', 'Morphine', 'Oxycodone', 'oxycodone', 'oxycodone, 81 placebo']","[""average' and 'worst' breathlessness; quality of life; function; and harms"", 'Chronic breathlessness', 'chronic breathlessness', 'proportion of people with >15% reduction from baseline in the intensity of breathlessness', 'nausea']","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0079816', 'cui_str': 'Medical Research'}, {'cui': 'C0222045'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]","[{'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0034380'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",157.0,0.703854,Placebo participants used more 'as needed' morphine (mean 7.0 versus 4.2 doses; p≤0.001).,"[{'ForeName': 'Diana H', 'Initials': 'DH', 'LastName': 'Ferreira', 'Affiliation': 'Discipline, Palliative and Supportive Services, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Louw', 'Affiliation': 'McCloud Consulting Group, Narabang Way, Belrose, New South Wales, Australia.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'McCloud', 'Affiliation': 'McCloud Consulting Group, Narabang Way, Belrose, New South Wales, Australia.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Fazekas', 'Affiliation': 'Discipline, Palliative and Supportive Services, Flinders University, Adelaide, South Australia, Australia; IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, New South Wales, Australia.'}, {'ForeName': 'Christine F', 'Initials': 'CF', 'LastName': 'McDonald', 'Affiliation': 'Austin Health, Heidelberg, Victoria, Australia; University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Meera R', 'Initials': 'MR', 'LastName': 'Agar', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, New South Wales, Australia.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Clark', 'Affiliation': 'Northern Sydney Local Health District, St Leonards, New South Wales, Australia; University of Sydney, Glebe, New South Wales, Australia.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'McCaffrey', 'Affiliation': 'Deakin Health Economics, School of Health and Social Development, Deakin University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Ekström', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, New South Wales, Australia; Department of Clinical Sciences Lund, Lund University, Faculty of Medicine, Respiratory Medicine and Allergology, Lund, Sweden.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Currow', 'Affiliation': 'Discipline, Palliative and Supportive Services, Flinders University, Adelaide, South Australia, Australia; IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, New South Wales, Australia. Electronic address: david.currow@uts.edu.au.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2019.10.017']
1500,31655296,Randomized Phase II Study of Paclitaxel plus Alisertib versus Paclitaxel plus Placebo as Second-Line Therapy for SCLC: Primary and Correlative Biomarker Analyses.,"INTRODUCTION


We assessed the Aurora A kinase inhibitor, alisertib, plus paclitaxel (henceforth referred to as alisertib/paclitaxel) as second-line treatment for SCLC.
METHODS


In this double-blind study, patients with relapsed or refractory SCLC were stratified by relapse type (sensitive versus resistant or refractory) and brain metastases and randomized 1:1 to alisertib/paclitaxel or placebo plus paclitaxel (henceforth referred to as placebo/paclitaxel) in 28-day cycles. The primary end point was progression-free survival (PFS). Associations of c-Myc expression in tumor tissue (prespecified) and genetic alterations in circulating tumor DNA (retrospective) with clinical outcome were evaluated.
RESULTS


A total of 178 patients were enrolled (89 in each arm). The median PFS was 3.32 months with alisertib/paclitaxel versus 2.17 months with placebo/paclitaxel (hazard ratio [HR] = 0.77, 95% confidence limit [CI]: 0.557-1.067, p = 0.113 in the intent-to-treat population versus HR = 0.71, 95% CI: 0.509-0.985, p = 0.038 with corrected analysis applied). Among 140 patients with genetic alternations, patients with cell cycle regulator mutations (cyclin-dependent kinase 6 gene [CDK6], retinoblastoma-like 1 gene [RBL1], retinoblastoma-like 2 gene [RBL2], and retinoblastoma 1 gene [RB1]) had significantly improved PFS with alisertib/paclitaxel versus with placebo/paclitaxel (3.68 versus 1.80 months, respectively [HR = 0.395, 95% CI: 0.239-0.654, p = 0.0003]), and overall survival (7.20 versus 4.47 months, respectively [HR = 0.427, 95% CI: 0.259-0.704, p = 0.00085]). A subset of patients with c-Myc expression showed significantly improved PFS with alisertib/paclitaxel. The incidence of grade 3 or higher drug-related adverse events was 67% (58 patients) with alisertib/paclitaxel versus 22% (25 patients) with placebo/paclitaxel. Twelve patients (14%) versus 11 (12%) died on study, including four versus zero treatment-related deaths.
CONCLUSIONS


Efficacy signals were seen with alisertib/paclitaxel in relapsed or refractory SCLC. c-Myc expression and mutations in cell cycle regulators may be potential predictive biomarkers of alisertib efficacy; further prospective validations are warranted.",2020,Incidence of grade ≥3 drug-related adverse events was 67% (58 patients) with alisertib/paclitaxel versus 22% (25 patients) with placebo/paclitaxel.,"['patients with relapsed/refractory SCLC were stratified by relapse type (sensitive versus resistant/refractory) and brain metastases', '178 patients were enrolled (89 in each arm', 'Small-Cell Lung Cancer', '140 patients with genetic alternations, patients with cell cycle regulator mutations (CDK6/RBL1/ RBL2/RB1', 'small-cell lung cancer (SCLC']","['Paclitaxel plus Alisertib versus Paclitaxel plus Placebo', 'alisertib/paclitaxel', 'alisertib/paclitaxel or placebo/paclitaxel', 'alisertib/paclitaxel versus placebo/paclitaxel', 'placebo/paclitaxel']","['Incidence of grade ≥3 drug-related adverse events', 'progression-free survival (PFS', 'overall survival', 'PFS', 'Median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain (disorder)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0149925', 'cui_str': 'Oat Cell Lung Cancer'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0919661', 'cui_str': 'Heart alternation'}, {'cui': 'C0007586', 'cui_str': 'Cell Division Cycle'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2987636'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",178.0,0.175453,Incidence of grade ≥3 drug-related adverse events was 67% (58 patients) with alisertib/paclitaxel versus 22% (25 patients) with placebo/paclitaxel.,"[{'ForeName': 'Taofeek K', 'Initials': 'TK', 'LastName': 'Owonikoko', 'Affiliation': 'Winship Cancer Institute of Emory University, Atlanta, Georgia. Electronic address: towonik@emory.edu.'}, {'ForeName': 'Huifeng', 'Initials': 'H', 'LastName': 'Niu', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts.'}, {'ForeName': 'Kristiaan', 'Initials': 'K', 'LastName': 'Nackaerts', 'Affiliation': 'KU Leuven, Universitaire Ziekenhuizen, Leuven, Belgium.'}, {'ForeName': 'Tibor', 'Initials': 'T', 'LastName': 'Csoszi', 'Affiliation': 'Hetenyi G Korhaz, Szolnok, Hungary.'}, {'ForeName': 'Gyula', 'Initials': 'G', 'LastName': 'Ostoros', 'Affiliation': 'Orszagos Koranyi TBC es Pulmonologiai Intezet, Budapest, Hungary.'}, {'ForeName': 'Zsuzsanna', 'Initials': 'Z', 'LastName': 'Mark', 'Affiliation': 'Tudogyogyintezet Torokbalint, Torokbalint, Hungary.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Baik', 'Affiliation': 'University of Washington Seattle Cancer Care Alliance, Seattle, Washington.'}, {'ForeName': 'Anil Abraham', 'Initials': 'AA', 'LastName': 'Joy', 'Affiliation': 'University of Alberta, Cross Cancer Institute, Edmonton, Alberta, Canada.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Chouaid', 'Affiliation': 'CHI de Créteil, Créteil, France.'}, {'ForeName': 'Jesus Corral', 'Initials': 'JC', 'LastName': 'Jaime', 'Affiliation': 'Hospital Universitario Virgen del Rocio, Seville, Spain.'}, {'ForeName': 'Vitezslav', 'Initials': 'V', 'LastName': 'Kolek', 'Affiliation': 'Fakultni Nemocnice Olomouc, Olomouc, Czech Republic.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Majem', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Jaromir', 'Initials': 'J', 'LastName': 'Roubec', 'Affiliation': 'Fakultni Nemocnice Ostrava, Ostrava Poruba, Czech Republic.'}, {'ForeName': 'Edgardo S', 'Initials': 'ES', 'LastName': 'Santos', 'Affiliation': 'Lynn Cancer Institute/Boca Raton Regional Hospital, Boca Raton, Florida.'}, {'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'Chiang', 'Affiliation': 'Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Speranza', 'Affiliation': 'Université de Sherbrooke, Centre intégré de cancérologie de la Montéregie, Hôpital Charles Le Moyne, Greenfield Park, Quebec City, Canada.'}, {'ForeName': 'Chandra P', 'Initials': 'CP', 'LastName': 'Belani', 'Affiliation': 'Penn State Cancer Institute, Hershey, Pennsylvania.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Chiappori', 'Affiliation': 'H. Lee Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Manish R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Florida Cancer Specialists/Sarah Cannon Research Institute, Sarasota, Florida.'}, {'ForeName': 'Krisztina', 'Initials': 'K', 'LastName': 'Czebe', 'Affiliation': 'Tudogyogyintezet Torokbalint, Törökbálint, Hungary.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Byers', 'Affiliation': 'Tudogyogyintezet Torokbalint, Törökbálint, Hungary.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Bahamon', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Sheldon-Waniga', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts.'}, {'ForeName': 'Eric F', 'Initials': 'EF', 'LastName': 'Kong', 'Affiliation': 'University of Texas M. D. Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Badola', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts.'}, {'ForeName': 'Hyunjin', 'Initials': 'H', 'LastName': 'Shin', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Bedford', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Ecsedy', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Bryant', 'Affiliation': 'University of Texas M. D. Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Jones', 'Affiliation': 'University of Texas M. D. Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Simmons', 'Affiliation': 'University of Texas M. D. Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'E Jane', 'Initials': 'EJ', 'LastName': 'Leonard', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts.'}, {'ForeName': 'Claudio Dansky', 'Initials': 'CD', 'LastName': 'Ullmann', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Spigel', 'Affiliation': 'Personal Genome Diagnostics, Baltimore, Maryland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2019.10.013']
1501,30267478,Population Pharmacokinetics and Exploratory Exposure-Response Relationships of Diazepam in Children Treated for Status Epilepticus.,"Diazepam is labeled for status epilepticus (SE) in children, but there are limited data characterizing its disposition in pediatric patients. We developed a population pharmacokinetic (PK) model of i.v. diazepam in children with SE. We evaluated relationships between PK parameters and both safety and efficacy, and simulated exposures using dosing regimens from the product label and clinical practice. The model was developed using prospective data from a pediatric clinical trial comparing diazepam to lorazepam for treatment of SE. Altogether, 87 patients aged ≥ 3 months to < 18 years contributed 162 diazepam concentrations. Diazepam PKs were well characterized by a two-compartment model scaled by body size. No significant or clinically important relationships were observed between diazepam PKs and safety or efficacy. Simulations demonstrated that, compared with label dosing, the study dose (0.2 mg/kg i.v., maximum 8 mg) resulted in greater frequency in rapidly achieving the target therapeutic range of 200-600 ng/mL.",2018,No significant or clinically important relationships were observed between diazepam PKs and safety or efficacy.,"['children with SE', 'Children Treated for Status Epilepticus', 'pediatric patients', '87 patients aged ≥\xa03\xa0months to ']","['diazepam', 'Diazepam', 'lorazepam']",['safety or efficacy'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0038220', 'cui_str': 'Status Epilepticus, Generalized'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0012010', 'cui_str': 'Diazepam'}, {'cui': 'C0024002', 'cui_str': 'Lorazepam'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",87.0,0.0555477,No significant or clinically important relationships were observed between diazepam PKs and safety or efficacy.,"[{'ForeName': 'Lawrence C', 'Initials': 'LC', 'LastName': 'Ku', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Christoph P', 'Initials': 'CP', 'LastName': 'Hornik', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Beechinor', 'Affiliation': 'Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Chamberlain', 'Affiliation': ""Division of Emergency Medicine, Children's National Medical Center, Washington, DC, USA.""}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Guptill', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Barrie', 'Initials': 'B', 'LastName': 'Harper', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Edmund V', 'Initials': 'EV', 'LastName': 'Capparelli', 'Affiliation': 'Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego, California, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Martz', 'Affiliation': 'Emmes Corporation, Rockville, Maryland, USA.'}, {'ForeName': 'Ravinder', 'Initials': 'R', 'LastName': 'Anand', 'Affiliation': 'Emmes Corporation, Rockville, Maryland, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cohen-Wolkowiez', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gonzalez', 'Affiliation': 'Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",CPT: pharmacometrics & systems pharmacology,['10.1002/psp4.12349']
1502,30455075,The effect of minocycline on symptoms in schizophrenia: Results from a randomized controlled trial.,"BACKGROUND


Studies have hypothesized that immunological abnormalities might contribute to schizophrenia, and basic science studies, as well as several clinical trials suggest that minocycline could be efficacious in ameliorating both positive and negative symptoms of schizophrenia. In this study we examined the effect of minocycline on schizophrenia in a large randomized controlled trial.
METHODS


We performed a 16-week, multi-center, double-blind, randomized, placebo-controlled study on 200 subjects with schizophrenia or schizoaffective disorder randomized to receive either minocycline (200 mg/day, n = 100), or placebo (n = 100) as an add-on to anti-psychotic treatment. The primary outcome measure was the PANSS total score.
RESULTS


Mixed models for repeated measures showed no significant difference between minocycline and placebo for total PANSS (p = 0.862), PANSS subscales, CGI or BACS.
CONCLUSIONS


Minocycline did not improve symptoms or cognition in schizophrenia.",2019,"RESULTS


Mixed models for repeated measures showed no significant difference between minocycline and placebo for total PANSS (p = 0.862), PANSS subscales, CGI or BACS.
","['200 subjects with schizophrenia or schizoaffective disorder', 'schizophrenia']","['Minocycline', 'minocycline and placebo', 'minocycline', 'placebo']","['symptoms or cognition in schizophrenia', 'PANSS total score', 'PANSS subscales, CGI or BACS']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective Disorder'}]","[{'cui': 'C0026187', 'cui_str': 'Minocycline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",200.0,0.704506,"RESULTS


Mixed models for repeated measures showed no significant difference between minocycline and placebo for total PANSS (p = 0.862), PANSS subscales, CGI or BACS.
","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Weiser', 'Affiliation': 'Department of Psychiatry, Sheba Medical Center, Tel Hashomer 52621, Israel; Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: mweiser@netvision.net.il.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Levi', 'Affiliation': 'Department of Psychiatry, Sheba Medical Center, Tel Hashomer 52621, Israel.'}, {'ForeName': 'Shimon', 'Initials': 'S', 'LastName': 'Burshtein', 'Affiliation': 'Department of Psychiatry, Sheba Medical Center, Tel Hashomer 52621, Israel.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Chiriță', 'Affiliation': 'Spitalul Clinic de Psihiatrie Socola, Iași. Șos. Bucium 36, Iași, Romania.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Cirjaliu', 'Affiliation': 'Clinica de Psihiatrie Palazu Mare, Constanta, Tomis 145, Constanța, Romania.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Gonen', 'Affiliation': 'Tangent Alzheimer Care, Breaza, Romania.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Yolken', 'Affiliation': ""Dept. of Pediatrics, John's Hopkins School of Medicine, Baltimore, MD, USA.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Davidson', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel; University of Nicosia Medical School, Cyprus.'}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Zamora', 'Affiliation': 'Dept. of Psychiatry, University of North Carolina, Chappel Hill, NC, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Davis', 'Affiliation': 'Department of Psychiatry, University of Illinois, Chicago, IL 60607, USA.'}]",Schizophrenia research,['10.1016/j.schres.2018.10.023']
1503,30444838,Impact of cumulative SBP and serious adverse events on efficacy of intensive blood pressure treatment: a randomized clinical trial.,"BACKGROUND


Intensive blood pressure lowering is increasingly gaining attention. In addition to higher baseline blood pressure, cumulative SBP, visit-to-visit variability, and treatment-induced serious adverse events (SAEs) could impact treatment efficacy over time. Our aim was to assess the impact of cumulative SBP and SAEs on intensive hypertension treatment efficacy in the Systolic Blood Pressure Intervention Trial (SPRINT) population during follow-up.
METHODS


Secondary analysis of the SPRINT study: a randomized, controlled, open-label trial including 102 clinical sites in the United States. We included 9068 SPRINT participants with 128 139 repeated SBP measurements. Participants were randomly assigned to intensive (target SBP < 120 mmHg) versus standard treatment (target SBP between 135 and 139 mmHg). We used cumulative joint models for longitudinal and survival data analysis. Primary outcome was a composite outcome of myocardial infarction, other acute coronary syndromes, acute decompensated heart failure, stroke, and cardiovascular mortality.
RESULTS


Although intensive treatment decreased the risk for the primary SPRINT outcome at the start of follow-up, its effect lost significance after 3.4 years of follow-up in the total SPRINT population and after 1.3, 1.3, 1.1, 1.8, 2.1, 1.8, and 3.4 years among participants with prevalent chronic kidney disease, prevalent cardiovascular disease, women, black individuals, participants less than 75 years, those with baseline SBP more than 132 mmHg, and individuals who suffered SAEs during follow-up, respectively.
CONCLUSION


The initial beneficial impact of intensive hypertension treatment might be offset by cumulative SBP and development of SAEs during follow-up.",2019,"Although intensive treatment decreased the risk for the primary SPRINT outcome at the start of follow-up, its effect lost significance after 3.4 years of follow-up in the total SPRINT population and after 1.3, 1.3, 1.1, 1.8, 2.1, 1.8, and 3.4 years among participants with prevalent chronic kidney disease, prevalent cardiovascular disease, women, black individuals, participants less than 75 years, those with baseline SBP more than 132 mmHg, and individuals who suffered SAEs during follow-up, respectively.
","['102 clinical sites in the United States', '9068 SPRINT participants with 128\u200a139 repeated SBP measurements']",['intensive blood pressure treatment'],"['cumulative SBP and development of SAEs', 'composite outcome of myocardial infarction, other acute coronary syndromes, acute decompensated heart failure, stroke, and cardiovascular mortality', 'baseline blood pressure, cumulative SBP, visit-to-visit variability, and treatment-induced serious adverse events (SAEs']","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0581377', 'cui_str': 'Decompensated cardiac failure (disorder)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",9068.0,0.233041,"Although intensive treatment decreased the risk for the primary SPRINT outcome at the start of follow-up, its effect lost significance after 3.4 years of follow-up in the total SPRINT population and after 1.3, 1.3, 1.1, 1.8, 2.1, 1.8, and 3.4 years among participants with prevalent chronic kidney disease, prevalent cardiovascular disease, women, black individuals, participants less than 75 years, those with baseline SBP more than 132 mmHg, and individuals who suffered SAEs during follow-up, respectively.
","[{'ForeName': 'Oscar L', 'Initials': 'OL', 'LastName': 'Rueda-Ochoa', 'Affiliation': 'Department of Epidemiology, Erasmus MC - University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Lyda Z', 'Initials': 'LZ', 'LastName': 'Rojas', 'Affiliation': 'Department of Epidemiology, Erasmus MC - University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Shahzad', 'Initials': 'S', 'LastName': 'Ahmad', 'Affiliation': 'Department of Epidemiology, Erasmus MC - University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Cornelia M', 'Initials': 'CM', 'LastName': 'van Duijn', 'Affiliation': 'Department of Epidemiology, Erasmus MC - University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Mohammad A', 'Initials': 'MA', 'LastName': 'Ikram', 'Affiliation': 'Department of Epidemiology, Erasmus MC - University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Jaap W', 'Initials': 'JW', 'LastName': 'Deckers', 'Affiliation': 'Department of Cardiology, Erasmus MC - University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Oscar H', 'Initials': 'OH', 'LastName': 'Franco', 'Affiliation': 'Department of Epidemiology, Erasmus MC - University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Rizopoulos', 'Affiliation': 'Department of Biostatistics, Erasmus MC - University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kavousi', 'Affiliation': 'Department of Epidemiology, Erasmus MC - University Medical Center Rotterdam, Rotterdam, The Netherlands.'}]",Journal of hypertension,['10.1097/HJH.0000000000002001']
1504,30341767,"Liraglutide, Sitagliptin, and Insulin Glargine Added to Metformin: The Effect on Body Weight and Intrahepatic Lipid in Patients With Type 2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease.","To investigate the effect of antidiabetic agents on nonalcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes mellitus (T2DM), 75 patients with T2DM and NAFLD under inadequate glycemic control by metformin were randomized (1:1:1) to receive add-on liraglutide, sitagliptin, or insulin glargine in this 26-week trial. The primary endpoint was the change in intrahepatic lipid (IHL) from baseline to week 26 as quantified by magnetic resonance imaging-estimated proton density fat fraction (MRI-PDFF). Secondary endpoints included changes in abdominal adiposity (subcutaneous adipose tissue [SAT] and visceral adipose tissue [VAT]), glycated hemoglobin, and body weight from baseline to week 26. We analysed data from intent-to-treat population. MRI-PDFF, VAT, and weight decreased significantly with liraglutide (15.4% ± 5.6% to 12.5% ± 6.4%, P < 0.001; 171.4 ± 27.8 to 150.5 ± 30.8, P = 0.003; 86.6 ± 12.9 kg to 82.9 ± 11.1 kg, P = 0.005, respectively) and sitagliptin (15.5% ± 5.6% to 11.7% ± 5.0%, P = 0.001; 153.4 ± 31.5 to 139.8 ± 27.3, P = 0.027; 88.2 ± 13.6 kg to 86.5 ± 13.2 kg, P = 0.005, respectively). No significant change in MRI-PDFF, VAT, or body weight was observed with insulin glargine. SAT decreased significantly in the liraglutide group (239.9 ± 69.0 to 211.3 ± 76.1; P = 0.020) but not in the sitagliptin and insulin glargine groups. Changes from baseline in MRI-PDFF, VAT, and body weight were significantly greater with liraglutide than insulin glargine but did not differ significantly between liraglutide and sitagliptin. Conclusion: Combined with metformin, both liraglutide and sitagliptin, but not insulin glargine, reduced body weight, IHL, and VAT in addition to improving glycemic control in patients with T2DM and NAFLD.",2019,"Changes from baseline in MRI-PDFF, VAT, and body weight were significantly greater with liraglutide than insulin glargine but did not differ significantly between liraglutide and sitagliptin.","['patients with T2DM and NAFLD', 'Patients With Type 2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease', 'patients with type 2 diabetes mellitus (T2DM), 75 patients with T2DM and NAFLD under inadequate glycemic control by metformin']","['metformin, both liraglutide and sitagliptin, but not insulin glargine', 'antidiabetic agents', 'liraglutide, sitagliptin, or insulin glargine', 'Liraglutide, Sitagliptin, and Insulin Glargine Added to Metformin', 'insulin glargine', 'liraglutide']","['Body Weight and Intrahepatic Lipid', 'change in intrahepatic lipid (IHL', 'MRI-PDFF, VAT, or body weight', 'changes in abdominal adiposity (subcutaneous adipose tissue [SAT] and visceral adipose tissue [VAT]), glycated hemoglobin, and body weight', 'nonalcoholic fatty liver disease (NAFLD', 'MRI-PDFF, VAT, and weight', 'body weight, IHL, and VAT', 'MRI-PDFF, VAT, and body weight', 'SAT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0332298', 'cui_str': 'Controlled by (attribute)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetics'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",75.0,0.0226657,"Changes from baseline in MRI-PDFF, VAT, and body weight were significantly greater with liraglutide than insulin glargine but did not differ significantly between liraglutide and sitagliptin.","[{'ForeName': 'Jinhua', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'The Third Affiliated Hospital of Sun Yat-sen University, Guangdong Provincial Key Laboratory of Diabetology, Guangzhou, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Yao', 'Affiliation': 'The Third Affiliated Hospital of Sun Yat-sen University, Guangdong Provincial Key Laboratory of Diabetology, Guangzhou, China.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Kuang', 'Affiliation': 'The First Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Xubin', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'The Third Affiliated Hospital of Sun Yat-sen University, Guangdong Provincial Key Laboratory of Diabetology, Guangzhou, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Changhai Hospital, Shanghai, China.'}, {'ForeName': 'Tianpei', 'Initials': 'T', 'LastName': 'Hong', 'Affiliation': 'Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Yushu', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Jingtao', 'Initials': 'J', 'LastName': 'Dou', 'Affiliation': 'Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Wenying', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'CHINA-JAPAN Friendship Hospital, Beijing, China.'}, {'ForeName': 'Guijun', 'Initials': 'G', 'LastName': 'Qin', 'Affiliation': 'The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': 'Henan Provincial Peoples Hospital, Zhengzhou, China.'}, {'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Sihui', 'Initials': 'S', 'LastName': 'Luo', 'Affiliation': 'The Third Affiliated Hospital of Sun Yat-sen University, Guangdong Provincial Key Laboratory of Diabetology, Guangzhou, China.'}, {'ForeName': 'Zhongyan', 'Initials': 'Z', 'LastName': 'Shan', 'Affiliation': 'The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Hongrong', 'Initials': 'H', 'LastName': 'Deng', 'Affiliation': 'The Third Affiliated Hospital of Sun Yat-sen University, Guangdong Provincial Key Laboratory of Diabetology, Guangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'The Third Affiliated Hospital of Sun Yat-sen University, Guangdong Provincial Key Laboratory of Diabetology, Guangzhou, China.'}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'The Third Affiliated Hospital of Sun Yat-sen University, Guangdong Provincial Key Laboratory of Diabetology, Guangzhou, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'The Third Affiliated Hospital of Sun Yat-sen University, Guangdong Provincial Key Laboratory of Diabetology, Guangzhou, China.'}, {'ForeName': 'Longyi', 'Initials': 'L', 'LastName': 'Zeng', 'Affiliation': 'The Third Affiliated Hospital of Sun Yat-sen University, Guangdong Provincial Key Laboratory of Diabetology, Guangzhou, China.'}, {'ForeName': 'Zhuang', 'Initials': 'Z', 'LastName': 'Kang', 'Affiliation': 'The Third Affiliated Hospital of Sun Yat-sen University, Guangdong Provincial Key Laboratory of Diabetology, Guangzhou, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Weng', 'Affiliation': 'The Third Affiliated Hospital of Sun Yat-sen University, Guangdong Provincial Key Laboratory of Diabetology, Guangzhou, China.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30320']
1505,31863149,Dietary approach to prevent obesity risk in Spina Bifida patients.,"PURPOSE


The aim of this prospective, analytic study is to evaluate if dietary approach can improve the body mass index (BMI) in a total of N = 152 patients with SB.
METHODS


BMI levels were evaluated stratifying patients by gender and age classes. Patients with BMI ≥ 25 have been randomized (1:1) in two groups: the ""diet"" group that received a dietary program and the ""no diet"" group that did not receive any program. Patients have been observed at the beginning of the study (T 0 ), and again at the end of the study, 1 year later (T 1 ). The main objective of the study was to evaluate BMI score in SB patients and how it could be influenced by dietary changes.
RESULTS


A total of 36.8% patients were classified as overweight or obese. Females present a mean BMI level higher than male, and patients older than 20 years old present the highest mean BMI. The ""diet"" group BMI decreased from 29.7 (± 3.8) to 27.7 (± 3.7) during the year of program. The mean BMI in the ""no diet"" group decreased from 30.3 (± 4.6) to 29.2 (± 4.7). There was a statistically significant difference in BMI level between groups (p < 0.0005). There was a statistically significant effect of time on BMI levels for the ""diet program"" group (p = 0.001), and there was NOT a statistically significant effect of time on BMI levels for the ""no diet group"" (p = 0.053).
CONCLUSIONS


Spina Bifida population has high risk of obesity which is related to other comorbidities such as diabetes and hypertension for example. Specific dietary program, since pediatric age, correlates with an improvement of quality of life, a reduction of BMI and of risk of related diseases with obesity. This study confirms that the transition to adulthood marks the beginning of the overweight status for many SB patients, but it also demonstrates that, following a dietary program, even disabled patients with limited training capabilities can achieve a BMI reduction.",2020,"There was a statistically significant effect of time on BMI levels for the ""diet program"" group (p = 0.001), and there was NOT a statistically significant effect of time on BMI levels for the ""no diet group"" (p = 0.053).
","['Patients with BMI\u2009≥\u200925', 'BMI levels were evaluated stratifying patients by gender and age classes', 'a total of N\u2009=\u2009152 patients with SB', 'A total of 36.8% patients were classified as overweight or obese', 'Spina Bifida patients', 'SB patients', 'Spina Bifida population']","['Dietary approach', 'diet"" group that received a dietary program and the ""no diet"" group that did not receive any program']","['mean BMI', 'obesity risk', 'quality of life', 'body mass index (BMI', 'BMI score', 'mean BMI level', 'BMI level', 'BMI levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0080178', 'cui_str': 'Schistorrhachis'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0034380'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",152.0,0.0135355,"There was a statistically significant effect of time on BMI levels for the ""diet program"" group (p = 0.001), and there was NOT a statistically significant effect of time on BMI levels for the ""no diet group"" (p = 0.053).
","[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Rendeli', 'Affiliation': 'Spina Bifida Center-Pediatric Department, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo Gemelli 8, 00168, Rome, Italy. Claudia.rendeli@unicatt.it.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kuczynska', 'Affiliation': 'Spina Bifida Center-Pediatric Department, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo Gemelli 8, 00168, Rome, Italy.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Giuliano', 'Affiliation': 'Spina Bifida Center-Pediatric Department, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo Gemelli 8, 00168, Rome, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Chiaretti', 'Affiliation': 'Spina Bifida Center-Pediatric Department, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo Gemelli 8, 00168, Rome, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ausili', 'Affiliation': 'Spina Bifida Center-Pediatric Department, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo Gemelli 8, 00168, Rome, Italy.'}]",Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery,['10.1007/s00381-019-04471-y']
1506,31654345,Laparoscopic One-Anastomosis Gastric Bypass with Band-Separated Gastric Pouch (OAGB-BSGP): a Randomized Controlled Trial.,"BACKGROUND


One-anastomosis gastric bypass with band-separated gastric pouch (OAGB-BSGP) is a novel ""staplerless"" version of OAGB. This randomized controlled trial (RCT) compared 2-year outcomes for OAGB-BSGP and standard OAGB.
METHODS


The parallel-group RCT randomly allocated patients to group A, staplerless OAGB-BSGP, or group B, stapled OAGB.
RESULTS


Respective mean values for groups A and B (n = 40 each): baseline body mass index (BMI, kg/m 2 ), 40.6 ± 5.6 vs 41.2 ± 6.4 (p = 0.64); abdominal bleeding (mL), 5.9 ± 8.0 vs 31.1 ± 30.5 (p < 0.0001). Two-year outcomes: BMI, 26.3 ± 3.2 vs 29.0 ± 4.7; %TWL, 34.1 ± 9.0 vs 29.3 ± 10.6, p < 0.03; %EBMIL, 94.3 ± 23.6 vs 77.9 ± 29.3, p < 0.007; bile reflux, n = 1 (2.5%) vs n = 7 (17.5%) (p = 0.05); revisions, n = 0 vs n = 4 (10.0%), p = 0.12.
CONCLUSIONS


At 2-year RCT follow-up, staplerless OAGB-BSGP patients had fewer complications, no revisions, and greater weight loss than stapled OAGB patients.
TRIAL REGISTRATION


ISRCTN56106651 (OSPAN-RCT).",2019,"At 2-year RCT follow-up, staplerless OAGB-BSGP patients had fewer complications, no revisions, and greater weight loss than stapled OAGB patients.
",[],"['staplerless OAGB-BSGP, or group B, stapled OAGB', 'Laparoscopic One-Anastomosis Gastric Bypass with Band-Separated Gastric Pouch (OAGB-BSGP', 'anastomosis gastric bypass with band-separated gastric pouch (OAGB-BSGP', 'OAGB-BSGP and standard OAGB']","['weight loss', 'abdominal bleeding']",[],"[{'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C1293124', 'cui_str': 'Stapling procedure'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C4319584', 'cui_str': 'Pouch (unit of presentation)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}]",,0.255256,"At 2-year RCT follow-up, staplerless OAGB-BSGP patients had fewer complications, no revisions, and greater weight loss than stapled OAGB patients.
","[{'ForeName': 'Oral', 'Initials': 'O', 'LastName': 'Ospanov', 'Affiliation': 'University Medical Center, Nur-Sultan, Kazakhstan. bariatric.kz@gmail.com.'}, {'ForeName': 'J N', 'Initials': 'JN', 'LastName': 'Buchwald', 'Affiliation': 'Division of Scientific Research Writing, Medwrite Medical Communications, Maiden Rock, WI, USA.'}, {'ForeName': 'Galymzhan', 'Initials': 'G', 'LastName': 'Yeleuov', 'Affiliation': 'University Medical Center, Nur-Sultan, Kazakhstan.'}, {'ForeName': 'Farida', 'Initials': 'F', 'LastName': 'Bekmurzinova', 'Affiliation': 'University Medical Center, Nur-Sultan, Kazakhstan.'}]",Obesity surgery,['10.1007/s11695-019-04236-1']
1507,31654154,"Acute effects of photobiomodulation therapy applied to respiratory muscles of chronic obstructive pulmonary disease patients: a double-blind, randomized, placebo-controlled crossover trial.","To investigate the effects of photobiomodulation applied to respiratory muscles on lung function, thoracoabdominal mobility, respiratory muscle strength, and functional capacity in COPD patients. This is a randomized double-blind crossover clinical trial. Twelve male COPD patients participated in the study. Participants were randomly allocated to receive two photobiomodulation sessions, 1 week apart: (1) an effective photobiomodulation session applied at the main respiratory muscles by means of a cluster with 69 light-emitting diodes (LEDs), containing 35 red (630 ± 10 nm; 10 mW; 0.2 cm 2 ) and 34 near-infrared (830 ± 20 nm; 10 mW; 0.2 cm 2 ) LEDs and (2) a sham photobiomodulation session, following the same procedures without emitting light. The primary outcomes were pulmonary function (spirometric indexes); thoracoabdominal mobility (cirtometry); respiratory muscle strength (maximal respiratory pressures), assessed at three moments: (1) baseline, (2) 1 h after intervention, and (3) 24 h after intervention; and the functional capacity, assessed by the 6-min walk test (6MWT) at baseline and 24 h after intervention. No significant interactions were found for spirometric variables, maximal respiratory pressures, and cirtometry. However, there was a Time × Condition interaction (F = 18.63; p = 0.001; η 2 p  = 0.62) in the walked distance on the 6MWT, with a significant increase after photobiomodulation intervention (p < 0.01) compared with the baseline. Photobiomodulation applied to respiratory muscles was effective in improving acute functional capacity in COPD patients. To the best of our knowledge, this is the first study assessing the effects of photobiomodulation applied to respiratory muscles in patients with COPD.",2020,"However, there was a Time × Condition interaction (F = 18.63; p = 0.001; η 2 p  = 0.62) in the walked distance on the 6MWT, with a significant increase after photobiomodulation intervention (p < 0.01) compared with the baseline.","['chronic obstructive pulmonary disease patients', 'patients with COPD', 'COPD patients', 'Twelve male COPD patients participated in the study']","['photobiomodulation therapy', 'placebo', 'photobiomodulation', 'photobiomodulation sessions, 1\xa0week apart: (1) an effective photobiomodulation session applied at the main respiratory muscles by means of a cluster with 69 light-emitting diodes (LEDs), containing 35 red (630\u2009±\u200910\xa0nm; 10\xa0mW; 0.2\xa0cm 2 ) and 34 near-infrared (830\u2009±\u200920\xa0nm; 10\xa0mW; 0.2\xa0cm 2 ) LEDs and (2) a sham photobiomodulation session']","['acute functional capacity', 'pulmonary function (spirometric indexes); thoracoabdominal mobility (cirtometry); respiratory muscle strength (maximal respiratory pressures), assessed at three moments: (1) baseline, (2) 1\xa0h after intervention, and (3) 24\xa0h after intervention; and the functional capacity, assessed by the 6-min walk test (6MWT', 'spirometric variables, maximal respiratory pressures, and cirtometry', 'lung function, thoracoabdominal mobility, respiratory muscle strength, and functional capacity']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C4019433', 'cui_str': 'LLLT'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0035231', 'cui_str': 'Ventilatory Muscles'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C4708165', 'cui_str': 'Six hundred and thirty'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C4517889', 'cui_str': '830 (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444467', 'cui_str': 'Thoracoabdominal (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0035231', 'cui_str': 'Ventilatory Muscles'}, {'cui': 'C4277579', 'cui_str': 'Maximum Respiratory Pressures'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}]",12.0,0.0797867,"However, there was a Time × Condition interaction (F = 18.63; p = 0.001; η 2 p  = 0.62) in the walked distance on the 6MWT, with a significant increase after photobiomodulation intervention (p < 0.01) compared with the baseline.","[{'ForeName': 'Guilherme Henrique Martins', 'Initials': 'GHM', 'LastName': 'de Souza', 'Affiliation': 'Pró-Reitoria de Pesquisa e Pós-Graduação, Universidade do Sagrado Coração, São Paulo, SP, Brazil.'}, {'ForeName': 'Cleber', 'Initials': 'C', 'LastName': 'Ferraresi', 'Affiliation': 'Post-graduation Program in Biomedical Engineering, Universidade Brasil, São Paulo, Brazil.'}, {'ForeName': 'Marlene Aparecida', 'Initials': 'MA', 'LastName': 'Moreno', 'Affiliation': 'Post-graduation Program in Human Movement Sciences, Methodist University of Piracicaba (UNIMEP), Piracicaba, SP, Brazil.'}, {'ForeName': 'Bruna Varanda', 'Initials': 'BV', 'LastName': 'Pessoa', 'Affiliation': 'Pró-Reitoria de Pesquisa e Pós-Graduação, Universidade do Sagrado Coração, São Paulo, SP, Brazil.'}, {'ForeName': 'Ana Paula Moraes', 'Initials': 'APM', 'LastName': 'Damiani', 'Affiliation': 'Pró-Reitoria de Pesquisa e Pós-Graduação, Universidade do Sagrado Coração, São Paulo, SP, Brazil.'}, {'ForeName': 'Vinicius Gasparotto', 'Initials': 'VG', 'LastName': 'Filho', 'Affiliation': 'Pró-Reitoria de Pesquisa e Pós-Graduação, Universidade do Sagrado Coração, São Paulo, SP, Brazil.'}, {'ForeName': 'Giovanny Viegas', 'Initials': 'GV', 'LastName': 'Dos Santos', 'Affiliation': 'Pró-Reitoria de Pesquisa e Pós-Graduação, Universidade do Sagrado Coração, São Paulo, SP, Brazil.'}, {'ForeName': 'Antonio Roberto', 'Initials': 'AR', 'LastName': 'Zamunér', 'Affiliation': 'Departamento de Kinesiología, Laboratorio de Investigación Clínica en Kinesiología, Universidad Católica del Maule, Avenida San Miguel 3605, Talca, Maule, Chile. beto.zam@gmail.com.'}]",Lasers in medical science,['10.1007/s10103-019-02885-3']
1508,31862830,Middle meningeal artery embolization as an adjuvant treatment to surgery for symptomatic chronic subdural hematoma: a pilot study assessing hematoma volume resorption.,"BACKGROUND


Chronic subdural hematoma (CSDH) is a common condition requiring surgical treatment; however, recurrence occurs in 15% of cases at 1 year. Middle meningeal artery (MMA) embolization has recently emerged as a promising treatment to prevent CSDH recurrence.
OBJECTIVE


To investigate the effect of MMA embolization on hematoma volume resorption (HVR) after surgery in symptomatic patients.
METHODS


From April 2018 to October 2018, participants with CSDH requiring surgery were prospectively randomized in a pilot study, and received either surgical treatment alone (ST group) or surgery and adjuvant MMA embolization (ST+MMAE group). The primary outcome was HVR measured on the 3 month CT scan compared with the immediate pre-embolization CT scan. Secondary outcomes were clinical recurrence of CSDH and safety measures.
RESULTS


46 patients were randomized and 41 of these achieved a 3 month follow-up . Twenty-one patients received MMA embolization. At 3 months, the HVR from postsurgical level was higher in the ST+MMAE group (mean difference 17.5 mL, 95% CI 3.87 to 31.16 mL; p=0.015). Two participants presented a CSDH recurrence (one in each group). One patient died (ST group). No MMA embolization-related adverse events were reported.
CONCLUSION


The addition of MMA embolization to surgery led to an increase in CSDH resorption at 3 months. One recurrence of CSDH was reported in each group, and there were no treatment-related complications.",2020,"At 3 months, the HVR from postsurgical level was higher in the ST+MMAE group (mean difference 17.5 mL, 95% CI 3.87 to 31.16 mL; p=0.015).","['46 patients', 'From April 2018 to October 2018, participants with CSDH requiring surgery', 'symptomatic patients', 'symptomatic chronic subdural hematoma']","['MMA embolization', 'surgical treatment alone (ST group) or surgery and adjuvant MMA embolization (ST+MMAE group', 'Middle meningeal artery embolization', 'Middle meningeal artery (MMA) embolization']","['MMA embolization-related adverse events', 'CSDH recurrence', 'recurrence of CSDH', 'clinical recurrence of CSDH and safety measures', 'CSDH resorption', 'hematoma volume resorption (HVR', 'HVR from postsurgical level', 'HVR measured on the 3\u2009month CT scan']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0749095', 'cui_str': 'Hemorrhage, Subdural, Chronic'}]","[{'cui': 'C0916871', 'cui_str': 'MMA(III)'}, {'cui': 'C0013931', 'cui_str': 'Embolotherapy'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0226147', 'cui_str': 'Structure of middle meningeal artery'}]","[{'cui': 'C0916871', 'cui_str': 'MMA(III)'}, {'cui': 'C0013931', 'cui_str': 'Embolotherapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}]",46.0,0.100507,"At 3 months, the HVR from postsurgical level was higher in the ST+MMAE group (mean difference 17.5 mL, 95% CI 3.87 to 31.16 mL; p=0.015).","[{'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Ng', 'Affiliation': 'Department of Neurosurgery, Montpellier University Medical Center, Montpellier, Occitanie, France s-ng@chu-montpellier.fr.'}, {'ForeName': 'Imad', 'Initials': 'I', 'LastName': 'Derraz', 'Affiliation': 'Department of Neuroradiology, Montpellier University Medical Center, Montpellier, Occitanie, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Boetto', 'Affiliation': 'Department of Neurosurgery, Montpellier University Medical Center, Montpellier, Occitanie, France.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Dargazanli', 'Affiliation': 'Department of Neuroradiology, Montpellier University Medical Center, Montpellier, Occitanie, France.'}, {'ForeName': 'Gaëtan', 'Initials': 'G', 'LastName': 'Poulen', 'Affiliation': 'Department of Neurosurgery, Montpellier University Medical Center, Montpellier, Occitanie, France.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Gascou', 'Affiliation': 'Department of Neuroradiology, Montpellier University Medical Center, Montpellier, Occitanie, France.'}, {'ForeName': 'Pierre-Henri', 'Initials': 'PH', 'LastName': 'Lefevre', 'Affiliation': 'Department of Neuroradiology, Montpellier University Medical Center, Montpellier, Occitanie, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Molinari', 'Affiliation': 'Department of Statistics, Montpellier University Medical Center, Montpellier, Occitanie, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Lonjon', 'Affiliation': 'Department of Neurosurgery, Montpellier University Medical Center, Montpellier, Occitanie, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Costalat', 'Affiliation': 'Department of Neuroradiology, Montpellier University Medical Center, Montpellier, Occitanie, France.'}]",Journal of neurointerventional surgery,['10.1136/neurintsurg-2019-015421']
1509,30231801,Short-term changes in added sugar consumption by adolescents reflected in the carbon isotope ratio of fingerstick blood.,"BACKGROUND


Consumption of added sugars (AS) and sugar-sweetened beverages (SSB) may adversely affect adolescents' weight and cardiovascular disease risk. Reliance on self-reported dietary assessment methods is a common research limitation, which could be overcome by dietary intake biomarkers.
AIM


The investigation was a proof-of-concept study to evaluate the proposed carbon isotope ratio (δ 13 C) biomarker of AS intake in adolescents, using a controlled feeding design.
METHODS


Participants ( n  = 33, age 15.3 years, 53% female) underwent two seven-day controlled feeding periods in a randomly assigned order. Diets were matched in composition except for AS content (5% or 25% of total energy). Fasting fingerstick blood samples were collected daily during each diet period.
RESULTS


Fingerstick δ 13 C values changed from day 1 to 8 by -0.05 ± 0.071‰ on 5% AS, and +0.03 ± 0.083‰ on 25% AS ( p  ≤ 0.001). Reliability was demonstrated between day 7 and 8 δ 13 C values on the 5% (ICC = 0.996 , p  ≤ 0.001) and 25% (ICC = 0.997,  p  ≤ 0.001) AS diets.
CONCLUSIONS


Larger scale investigations are warranted to determine if this technique could be applied to population-level research in order to help assess the effectiveness of interventions aimed at reducing the consumption of AS or SSB intake.",2018,"RESULTS


Fingerstick δ 13 C values changed from day 1 to 8 by -0.05 ± 0.071‰ on 5% AS, and +0.03 ± 0.083‰ on 25% AS ( p ≤ 0.001).","['Participants ( n = 33, age 15.3 years']",['added sugars (AS) and sugar-sweetened beverages (SSB'],"['Fasting fingerstick blood samples', 'Reliability', 'carbon isotope ratio of fingerstick blood']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517578', 'cui_str': '15.3'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0007017', 'cui_str': 'Carbon Isotopes'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0005768'}]",,0.0344239,"RESULTS


Fingerstick δ 13 C values changed from day 1 to 8 by -0.05 ± 0.071‰ on 5% AS, and +0.03 ± 0.083‰ on 25% AS ( p ≤ 0.001).","[{'ForeName': 'Sarah V', 'Initials': 'SV', 'LastName': 'Liu', 'Affiliation': 'Department of Human Nutrition, Foods, and Exercise, Virginia Tech, Blacksburg, USA.'}, {'ForeName': 'Lori B', 'Initials': 'LB', 'LastName': 'Moore', 'Affiliation': 'Department of Human Nutrition, Foods, and Exercise, Virginia Tech, Blacksburg, USA.'}, {'ForeName': 'Tanya M', 'Initials': 'TM', 'LastName': 'Halliday', 'Affiliation': 'Department of Human Nutrition, Foods, and Exercise, Virginia Tech, Blacksburg, USA.'}, {'ForeName': 'A Hope', 'Initials': 'AH', 'LastName': 'Jahren', 'Affiliation': 'Centre for Earth Evolution and Dynamics, University of Oslo, Norway.'}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Savla', 'Affiliation': 'Department of Human Development and Center for Gerontology, Virginia Tech, Blacksburg, USA.'}, {'ForeName': 'Valisa E', 'Initials': 'VE', 'LastName': 'Hedrick', 'Affiliation': 'Department of Human Nutrition, Foods, and Exercise, Virginia Tech, Blacksburg, USA.'}, {'ForeName': 'Elaina L', 'Initials': 'EL', 'LastName': 'Marinik', 'Affiliation': 'Department of Human Nutrition, Foods, and Exercise, Virginia Tech, Blacksburg, USA.'}, {'ForeName': 'Brenda M', 'Initials': 'BM', 'LastName': 'Davy', 'Affiliation': 'Department of Human Nutrition, Foods, and Exercise, Virginia Tech, Blacksburg, USA.'}]",Nutrition and health,['10.1177/0260106018799522']
1510,31652237,Impact of Exercise-Nutritional State Interactions in Patients with Type 2 Diabetes.,"INTRODUCTION


This study examines the role of nutritional status during exercise training in patients with type 2 diabetes mellitus by investigating the effect of endurance-type exercise training in the fasted versus the fed state on clinical outcome measures, glycemic control, and skeletal muscle characteristics in male type 2 diabetes patients.
METHODS


Twenty-five male patients (glycated hemoglobin (HbA1c), 57 ± 3 mmol·mol (7.4% ± 0.3%)) participated in a randomized 12-wk supervised endurance-type exercise intervention, with exercise being performed in an overnight-fasted state (n = 13) or after consuming breakfast (n = 12). Patients were evaluated for glycemic control, blood lipid profiles, body composition and physical fitness, and skeletal muscle gene expression.
RESULTS


Exercise training was well tolerated without any incident of hypoglycemia. Exercise training significantly decreased whole-body fat mass (-1.6 kg) and increased high-density lipoprotein concentrations (+2 mg·dL), physical fitness (+1.7 mL·min·kg), and fat oxidation during exercise in both groups (PTIME < 0.05), with no between-group differences (PTIME × GROUP > 0.05). HbA1c concentrations significantly decreased after exercise training (PTIME < 0.001), with a significant greater reduction after consuming breakfast (-0.30% ± 0.06%) compared with fasted state (-0.08% ± 0.06%; mean difference, 0.21%; PTIME × GROUP = 0.016). No interaction effects were observed for skeletal muscle genes related to lipid metabolism or oxidative capacity.
CONCLUSIONS


Endurance-type exercise training in the fasted or fed state do not differ in their efficacy to reduce fat mass, increase fat oxidation capacity, and increase cardiorespiratory fitness and high-density lipoprotein concentrations or their risk of hypoglycemia in male patients with type 2 diabetes. HbA1c seems to be improved more with exercise performed in the postprandial compared with the postabsorptive state.",2020,"HbA1c concentrations significantly decreased after exercise training (PTIME<0.001), with a significant greater reduction in FedEx (-0.30±0.06%) compared to FastEx","['Twenty-five male patients (HbA1c 57±3 mmol/mol (7.4±0.3%)) participated in a randomized 12-week', 'male patients with type 2 diabetes', 'male type 2 diabetes patients', 'patients with type 2 diabetes mellitus', 'Patients with Type 2 Diabetes']","['Exercise-Nutritional State Interactions', 'FastEx', 'endurance-type exercise training', 'Exercise training', 'supervised endurance-type exercise intervention, with exercise being performed in an overnight fasted state (FastEx, n=13) or after consuming breakfast (FedEx', 'Endurance-type exercise training', 'exercise training']","['HDL concentrations (+2mg*dL), physical fitness (+1.7mL*min*kg) and fat oxidation during exercise', 'whole-body fat mass', 'glycemic control, blood lipid profiles, body composition and physical fitness, and skeletal muscle gene expression', 'lipid metabolism or oxidative capacity', 'Glycated haemoglobin', 'cardiorespiratory fitness and HDL concentrations', 'HbA1c concentrations', 'FedEx', 'tolerated without any incident of hypoglycemia']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}]","[{'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0587107', 'cui_str': 'During exercise (qualifier value)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}]",25.0,0.0307651,"HbA1c concentrations significantly decreased after exercise training (PTIME<0.001), with a significant greater reduction in FedEx (-0.30±0.06%) compared to FastEx","[{'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Verboven', 'Affiliation': 'Rehabilitation Research Centre (REVAL), Biomedical Research Unit (BIOMED), Faculty of Rehabilitation Sciences, Hasselt University, Diepenbeek, BELGIUM.'}, {'ForeName': 'Inez', 'Initials': 'I', 'LastName': 'Wens', 'Affiliation': 'Rehabilitation Research Centre (REVAL), Biomedical Research Unit (BIOMED), Faculty of Rehabilitation Sciences, Hasselt University, Diepenbeek, BELGIUM.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Vandenabeele', 'Affiliation': 'Rehabilitation Research Centre (REVAL), Biomedical Research Unit (BIOMED), Faculty of Rehabilitation Sciences, Hasselt University, Diepenbeek, BELGIUM.'}, {'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Stevens', 'Affiliation': 'Rehabilitation Research Centre (REVAL), Biomedical Research Unit (BIOMED), Faculty of Rehabilitation Sciences, Hasselt University, Diepenbeek, BELGIUM.'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Celie', 'Affiliation': 'Department of Endocrinology, Ghent University Hospital, Ghent, BELGIUM.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Lapauw', 'Affiliation': 'Department of Endocrinology, Ghent University Hospital, Ghent, BELGIUM.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dendale', 'Affiliation': 'Heart Centre Hasselt, Jessa Hospital, Hasselt, BELGIUM.'}, {'ForeName': 'Luc J C', 'Initials': 'LJC', 'LastName': 'VAN Loon', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+, Maastricht, NETHERLANDS.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Calders', 'Affiliation': 'Department of Endocrinology, Ghent University Hospital, Ghent, BELGIUM.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Hansen', 'Affiliation': 'Rehabilitation Research Centre (REVAL), Biomedical Research Unit (BIOMED), Faculty of Rehabilitation Sciences, Hasselt University, Diepenbeek, BELGIUM.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002165']
1511,31652109,Cold-Water Immersion Does Not Accelerate Performance Recovery After 10-km Street Run: Randomized Controlled Clinical Trial.,"The use of strategies to assure better post-effort recovery is frequent in sports settings. There are several interventions available for exercise induced muscle damage recovery, but cold-water immersion (CWI) stands out among them. The effects of CWI are unclear in the literature and, although the number of street runners has been growing, there is a gap in the scientific evidence regarding the use of CWI to recover runners' performance after a 10-km street run.  Purpose:  The goal of our study was to analyze the effects of CWI on the recovery of muscle damage markers after a 10-km street run.  Method:  We randomly assigned thirty male recreational street runners, immediately after a 10-km street run, into three recovery groups: control (rest for 10 minutes), immersion (10 min immersed in water without ice at room temperature) and CWI (10 min immersed in water with ice at 10ºC). We assessed pain, triple hop distance, extensor peak torque and blood creatine kinase levels pre- and post-run, post-intervention and 24 hours after the run.  Results:  The 10-km run was enough to decrease triple hop distance and extensor peak torque, and increase levels of creatine kinase ( p  < 0.05); however, we found no time/group interactions in any of the assessed variables after we applied the appropriate interventions ( p  > 0.05).  Conclusion:  10-min CWI at 10°C was no more effective than water immersion and rest in recovering muscle damage markers after 10-km runs.",2020,"The 10-km run was enough to decrease triple hop distance and extensor peak torque, and increase levels of creatine kinase ( p  < 0.05); however, we found no time/group interactions in any of the assessed variables after we applied the appropriate interventions ( p  > 0.05).  ","['thirty male recreational street runners, immediately after a 10-km street run, into three recovery groups']","['Cold-water Immersion', 'control (rest for 10 minutes), immersion (10 min immersed in water without ice at room temperature) and CWI', 'CWI']","['pain, triple hop distance, extensor peak torque and blood creatine kinase levels pre- and post-run, post-intervention and 24 hours after the run', 'triple hop distance and extensor peak torque, and increase levels of creatine kinase']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0442658', 'cui_str': 'Street (environment)'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C4708833', 'cui_str': 'Cold water'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0349714', 'cui_str': 'Icing (substance)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C4018995', 'cui_str': 'Hop'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0853178', 'cui_str': 'Blood creatine'}, {'cui': 'C4521566', 'cui_str': 'Kinase'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}]",30.0,0.0695893,"The 10-km run was enough to decrease triple hop distance and extensor peak torque, and increase levels of creatine kinase ( p  < 0.05); however, we found no time/group interactions in any of the assessed variables after we applied the appropriate interventions ( p  > 0.05).  ","[{'ForeName': 'Glauko', 'Initials': 'G', 'LastName': 'Dantas', 'Affiliation': 'Federal University of São Carlos.'}, {'ForeName': 'Alef', 'Initials': 'A', 'LastName': 'Barros', 'Affiliation': 'Federal University of Rio Grande do Norte.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Silva', 'Affiliation': 'Federal University of Rio Grande do Norte.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Belém', 'Affiliation': 'Federal University of Rio Grande do Norte.'}, {'ForeName': 'Vitoria', 'Initials': 'V', 'LastName': 'Ferreira', 'Affiliation': 'Federal University of Rio Grande do Norte.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Fonseca', 'Affiliation': 'Federal University of Rio Grande do Norte.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Castro', 'Affiliation': 'Federal University of Rio Grande do Norte.'}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Santos', 'Affiliation': 'Federal University of Rio Grande do Norte.'}, {'ForeName': 'Telma', 'Initials': 'T', 'LastName': 'Lemos', 'Affiliation': 'Federal University of Rio Grande do Norte.'}, {'ForeName': 'Wouber', 'Initials': 'W', 'LastName': 'Hérickson', 'Affiliation': 'Federal University of Rio Grande do Norte.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2019.1659477']
1512,31647564,Efficacy of a Texting Program to Promote Cessation Among Pregnant Smokers: A Randomized Control Trial.,"INTRODUCTION


Smoking during pregnancy poses serious risks to baby and mother. Few disseminable programs exist to help pregnant women quit or reduce their smoking. We hypothesized that an SMS text-delivered scheduled gradual reduction (SGR) program plus support texts would outperform SMS support messages alone.
METHODS


We recruited 314 pregnant women from 14 prenatal clinics. Half of the women received theory-based support messages throughout their pregnancy to promote cessation and prevent relapse. The other half received the support messages plus alert texts that gradually reduced their smoking more than 3-5 weeks. We conducted surveys at baseline, end of pregnancy, and 3 months postpartum. Our primary outcome was biochemically validated 7-day point prevalence abstinence at late pregnancy. Our secondary outcome was reduction in cigarettes per day.
RESULTS


Adherence to the SGR was adequate with 70% responding to alert texts to smoke within 60 minutes. Women in both arms quit smoking at the same rate (9%-12%). Women also significantly reduced their smoking from baseline to the end of pregnancy from nine cigarettes to four; we found no arm differences in reduction.
CONCLUSIONS


Support text messages alone produced significant quit rates above naturally occurring quitting. SGR did not add significantly to helping women quit or reduce. Sending support messages can reach many women and is low-cost. More obstetric providers might consider having patients who smoke sign up for free texting programs to help them quit.
IMPLICATIONS


A disseminable texting program helped some pregnant women quit smoking.Clinical Trial Registration number: NCT01995097.",2020,SGR did not add significantly to helping women quit or reduce.,"['pregnant women quit smoking', 'Pregnant Smokers', '314 pregnant women from 14 prenatal clinics']","['Texting Program', 'SMS text-delivered scheduled gradual reduction (SGR) program plus support texts']","['7-day point prevalence abstinence at late pregnancy', 'reduction in cigarettes per day', 'quit rates']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439833', 'cui_str': 'Gradual (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': 'per day'}]",314.0,0.068689,SGR did not add significantly to helping women quit or reduce.,"[{'ForeName': 'Kathryn I', 'Initials': 'KI', 'LastName': 'Pollak', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Lyna', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC.'}, {'ForeName': 'Devon', 'Initials': 'D', 'LastName': 'Noonan', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Bejarano Hernandez', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Subudhi', 'Affiliation': 'Doctor of Medicine Program, Eastern Virginia Medical School, Norfolk, VA.'}, {'ForeName': 'Geeta K', 'Initials': 'GK', 'LastName': 'Swamy', 'Affiliation': 'Department of Obstetrics and Gynecology, DUMC 3083, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Fish', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz174']
1513,30175648,Effectiveness of cognitive-behavioral therapy (CBT) in improving the quality of life and psychological fatigue in women with polycystic ovarian syndrome: a randomized controlled clinical trial.,"Introduction:  Given the increasing prevalence of complications caused by the polycystic ovarian syndrome (PCOS) such as medical and psychological problems and also the chronicity of this disease, patients with the PCOS tend to experience lower quality of life and greater psychological fatigue similar to other patients with chronic diseases. This study was conducted to determine the effects of cognitive-behavioral therapy (CBT) on the quality of life and psychological fatigue in women with the PCOS.  Methods:  This randomized controlled clinical trial study, conducted from 2016 to 2017, enrolled 74 women aged between 18 and 35 years from the Iranian city of Saqqez. The participants were assigned to a CBT group and a control group via block randomization. The intervention group received 8 weekly CBT sessions between 45 and 60 minutes each. The Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ) and the Fatigue Impact Scale (FIS) were completed by the patients before and after the intervention.  Results:  No significant differences were observed between the two groups before the intervention in terms of sociodemographic characteristics and the mean scores of quality of life and psychological fatigue. After the intervention, the mean (standard deviation [SD]) of the quality of life score was 60.2 (13.3) in the intervention group and 24.4 (15) in the control group, with the mean score of quality of life being significantly higher in the intervention group than in the control group (adjusted mean difference = 33.1). The mean (SD) score of psychological fatigue was 28.2 (13.9) in the intervention group and 78.2 (37.1) in the control group, with the mean score of psychological fatigue being significantly lower in the intervention group than in the control group (-54.8).  Conclusions:  The results showed that CBT was able to reduce fatigue and improve quality of life in our sample of women with the PCOS and ultimately boost their health.",2019,No significant differences were observed between the two groups before the intervention in terms of sociodemographic characteristics and the mean scores of quality of life and psychological fatigue.,"['women with the PCOS', 'conducted from 2016 to 2017, enrolled 74 women aged between 18 and 35\u2009years from the Iranian city of Saqqez', 'women with polycystic ovarian syndrome']","['control group via block randomization', 'cognitive-behavioral therapy (CBT', 'CBT']","['quality of life score', 'quality of life and greater psychological fatigue', 'fatigue and improve quality of life', 'mean score of psychological fatigue', 'quality of life and psychological fatigue', 'Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ) and the Fatigue Impact Scale (FIS', 'sociodemographic characteristics and the mean scores of quality of life and psychological fatigue', 'mean score of quality of life', 'mean (SD) score of psychological fatigue']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0554962', 'cui_str': 'Iranian (NMO) (ethnic group)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2733557', 'cui_str': 'Fatigue impact scale (assessment scale)'}]",74.0,0.0577113,No significant differences were observed between the two groups before the intervention in terms of sociodemographic characteristics and the mean scores of quality of life and psychological fatigue.,"[{'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Abdollahi', 'Affiliation': 'Department of Midwifery School of Nursing and Midwifery, Tabriz University of Medical Sciences , Tabriz , Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Mirghafourvand', 'Affiliation': 'Social Determinants of Health Research Centre, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences , Tabriz , Iran.'}, {'ForeName': 'Jalil Kheyradin', 'Initials': 'JK', 'LastName': 'Babapour', 'Affiliation': 'Faculty of Psychology, Tabriz University , Tabriz , Iran.'}, {'ForeName': 'Mozhdeh', 'Initials': 'M', 'LastName': 'Mohammadi', 'Affiliation': 'Obstetrics and Gynecology Specialist, Imam Khomeini Hospital , Saqez , Iran.'}]",Journal of psychosomatic obstetrics and gynaecology,['10.1080/0167482X.2018.1502265']
1514,31649219,Use of hyperbaric oxygen therapy (HBOT) in chronic diabetic wound - A randomised trial.,"INTRODUCTION


The purpose of this study was to investigate the effect of hyperbaric oxygen therapy (HBOT) towards diabetic foot ulcer (DFU) patients in addition to the standard wound care management.
METHODS


Fifty-eight diabetic patients with ulcers at Wagner Grade 2 and above involved in this study after presented at two study centres of tertiary teaching hospitals. The assigned patients received conventional wound care with additional HBOT given at 2.4 ATA for 90 minutes. Patients in the control group who received conventional wound care only were treated and observed for 30 days. The progress of wound healing was observed and measured at day 0, 10, 20 and 30 of study. The data collected were analysed using SPSS software (ver. 22) to study the association of HBOT towards healing of the diabetic foot ulcers.
RESULTS


Repeated Measures ANOVA analysis with Greenhouse-Geisser correction indicated that the means of wound size over time points (Day 0, 10, 20 and 30) among patients under HBOT group were statistically significantly different [F(1,61)=30.86, p<0.001)] compared to conventional therapy group. Multiple logistic regression analysis showed that HBOT group has nearly 44 times higher odds to achieve at least 30% wound size reduction within the study period (95%CI: 7.18, 268.97, p<0.001).
CONCLUSION


The results obtained in this study indicated that as an adjunctive therapy to conventional wound care, HBOT affected the rate of healing in diabetic foot ulcers significantly in terms of wound size reduction when compared to administering the conventional wound care alone.",2019,"Multiple logistic regression analysis showed that HBOT group has nearly 44 times higher odds to achieve at least 30% wound size reduction within the study period (95%CI: 7.18, 268.97, p<0.001).
","['Fifty-eight diabetic patients with ulcers at Wagner Grade 2 and above involved in this study after presented at two study centres of tertiary teaching hospitals', 'diabetic foot ulcer (DFU) patients in addition to the standard wound care management', 'chronic diabetic wound ']","['conventional wound care', 'hyperbaric oxygen therapy (HBOT', 'conventional wound care with additional HBOT']","['wound size over time points', 'wound healing', 'rate of healing in diabetic foot ulcers']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer (disorder)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1272654', 'cui_str': 'Wound care management'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0886052', 'cui_str': 'Administers care to wound sites'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric Oxygen Therapy'}]","[{'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer (disorder)'}]",58.0,0.0473972,"Multiple logistic regression analysis showed that HBOT group has nearly 44 times higher odds to achieve at least 30% wound size reduction within the study period (95%CI: 7.18, 268.97, p<0.001).
","[{'ForeName': 'N A R', 'Initials': 'NAR', 'LastName': 'Nik Hisamuddin', 'Affiliation': 'Universiti Sains Malaysia, School of Medical Sciences, Health Campus, Kelantan, Malaysia. nhliza@hotmail.com.'}, {'ForeName': 'W N', 'Initials': 'WN', 'LastName': 'Wan Mohd Zahiruddin', 'Affiliation': 'Universiti Sains Malaysia, School of Medical Sciences, Health Campus, Kelantan, Malaysia.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Mohd Yazid', 'Affiliation': 'Pusat Perubatan Canselor Tuanku Mukhriz, UKM, Cheras, Malaysia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rahmah', 'Affiliation': 'Kuala Lumpur Hyperbaric Center, Taman Tasik Titiwangsa, Kuala Lumpur, Malaysia.'}]",The Medical journal of Malaysia,[]
1515,30033738,Joint Fluid Proteome after Anterior Cruciate Ligament Rupture Reflects an Acute Posttraumatic Inflammatory and Chondrodegenerative State.,"OBJECTIVE


The purpose of this study was to evaluate changes in the synovial fluid proteome following acute anterior cruciate ligament (ACL) injury.
DESIGN


This study represents a secondary analysis of synovial fluid samples collected from the placebo group of a previous randomized trial. Arthrocentesis was performed twice on 6 patients with an isolated acute ACL tear at a mean of 6 and 14 days postinjury. Synovial fluid was analyzed by a highly multiplexed assay of 1129 proteins (SOMAscan version 3, SomaLogic, Inc., Boulder, CO). Pathway analysis using DAVID was performed; genes included met 3 criteria: significant change between the 2 study time points using a paired  t  test, significant change between the 2 study time points using a Mann-Whitney nonparametric test, and significant Benjamini  post hoc  analysis.
RESULTS


Fifteen analytes demonstrated significant increases between time points. Five of the 15 have been previously associated with the onset and/or severity of rheumatoid arthritis, including apoliopoprotein E and isoform E3, vascular cell adhesion protein 1, interleukin-34, and cell surface glycoprotein CD200 receptor 1. Chondrodegenerative enzymes and products of cartilage degeneration all increased over time following injury: MMP-1 ( P  = 0.08, standardized response mean [SRM] = 1.00), MMP-3 ( P  = 0.05, SRM = 0.90), ADAM12 ( P  = 0.03, SRM = 1.31), aggrecan ( P  = 0.08, SRM = 1.13), and CTX-II ( P  = 0.07, SRM = 0.56). Notable pathways that were differentially expressed following injury were the cytokine-cytokine receptor interaction and osteoclast differentiation pathways.
CONCLUSIONS


The proteomic results and pathway analysis demonstrated a pattern of cartilage degeneration, not only consistent with previous findings but also changes consistent with an inflammatory arthritogenic process post-ACL injury.",2020,Chondrodegenerative enzymes and products of cartilage degeneration all increased over time following injury:,"['injury', 'acute anterior cruciate ligament (ACL) injury', 'Anterior Cruciate Ligament Rupture']","['placebo', 'ADAM12']","['MMP-3', 'MMP-1', 'Chondrodegenerative enzymes and products of cartilage degeneration']","[{'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C1456574', 'cui_str': 'Anterior Cruciate Ligament Injuries'}, {'cui': 'C0409312', 'cui_str': 'Anterior Cruciate Ligament Tear'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C3541394', 'cui_str': 'Enzymes'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0011164', 'cui_str': 'Degenerative abnormality'}]",6.0,0.0632535,Chondrodegenerative enzymes and products of cartilage degeneration all increased over time following injury:,"[{'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'King', 'Affiliation': 'Department of Orthopedic Surgery, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Rowland', 'Affiliation': 'Central Texas Sports Medicine & Orthopedics, Bryan, TX, USA.'}, {'ForeName': 'Alejandro G', 'Initials': 'AG', 'LastName': 'Villasante Tezanos', 'Affiliation': 'College of Health Sciences, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Warwick', 'Affiliation': 'College of Medicine, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Virginia B', 'Initials': 'VB', 'LastName': 'Kraus', 'Affiliation': 'Duke Molecular Physiology Institute, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lattermann', 'Affiliation': ""Department of Orthopaedic Surgery, Harvard Medical School and Brigham and Women's Hosptial, Chestnut Hill, MS, USA.""}, {'ForeName': 'Cale A', 'Initials': 'CA', 'LastName': 'Jacobs', 'Affiliation': 'Department of Orthopedic Surgery, University of Kentucky, Lexington, KY, USA.'}]",Cartilage,['10.1177/1947603518790009']
1516,30106494,Gender differences in demographic and clinical characteristics of patients with opioid use disorder entering a comparative effectiveness medication trial.,"BACKGROUND & OBJECTIVES


We investigated gender differences in individuals with opioid use disorder (OUD) receiving inpatient services and entering a randomized controlled trial comparing extended-release naltrexone to buprenorphine.
METHODS


Participants (N = 570) provided demographic, substance use, and psychiatric information.
RESULTS


Women were significantly younger, more likely to identify as bisexual, live with a sexual partner, be financially dependent, and less likely employed. Women reported significantly greater psychiatric comorbidity and risk behaviors, shorter duration but similar age of onset of opioid use.
DISCUSSION/CONCLUSIONS


Findings underscore economic, psychiatric, and infection vulnerability among women with OUD.
SCIENTIFIC SIGNIFICANCE


Interventions targeting these disparities should be explored, as women may face complicated treatment initiation, retention, and recovery. (Am J Addict 2018;27:465-470).",2018,"RESULTS


Women were significantly younger, more likely to identify as bisexual, live with a sexual partner, be financially dependent, and less likely employed.","['individuals with opioid use disorder (OUD) receiving inpatient services', 'women with OUD', 'Participants (N\u2009=\u2009570) provided demographic, substance use, and psychiatric information', 'patients with opioid use disorder entering']",['naltrexone to buprenorphine'],['psychiatric comorbidity and risk behaviors'],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}]","[{'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}]",,0.242528,"RESULTS


Women were significantly younger, more likely to identify as bisexual, live with a sexual partner, be financially dependent, and less likely employed.","[{'ForeName': 'Aimee N C', 'Initials': 'ANC', 'LastName': 'Campbell', 'Affiliation': 'Department of Psychiatry and New York State Psychiatric Institute, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Celestina', 'Initials': 'C', 'LastName': 'Barbosa-Leiker', 'Affiliation': 'College of Nursing, Washington State University, New York, New York.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Hatch-Maillette', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Alcohol and Drug Abuse Institute, University of Washington, Seattle, Washington.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Mennenga', 'Affiliation': 'Department of Psychiatry, New York University School of Medicine, New York, New York.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': 'Department of Biostatistics, Columbia University Mailman School of Public Health, New York, New York.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Scodes', 'Affiliation': 'Department of Psychiatry and New York State Psychiatric Institute, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Saraiya', 'Affiliation': 'Derner School of Psychology, Adelphi University, Garden City, New York.'}, {'ForeName': 'Shannon G', 'Initials': 'SG', 'LastName': 'Mitchell', 'Affiliation': 'Friends Research Institute, Inc., Baltimore, Maryland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rotrosen', 'Affiliation': 'Department of Psychiatry, New York University School of Medicine, New York, New York.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Novo', 'Affiliation': 'Department of Psychiatry, New York University School of Medicine, New York, New York.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'Department of Psychiatry and New York State Psychiatric Institute, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Shelly F', 'Initials': 'SF', 'LastName': 'Greenfield', 'Affiliation': 'Harvard Medical School Department of Psychiatry and McLean Hospital, Boston, Massachusetts.'}]",The American journal on addictions,['10.1111/ajad.12784']
1517,30083968,Repair of only anterior talofibular ligament resulted in similar outcomes to those of repair of both anterior talofibular and calcaneofibular ligaments.,"PURPOSE


To compare the surgical outcomes of the two different ankle stabilization techniques.
METHODS


This randomized controlled trial aimed to compare the outcomes of the modified Broström procedure with [calcaneofibular ligament (CFL) group] or without CFL repair [anterior talofibular ligament (ATFL) only group]. Of the 50 patients randomly assigned to two groups, 43 were followed up prospectively for ≥ 2 years (CFL group: 22 patients, 36.6 ± 13.1 months; ATFL Only group: 21 patients, 35.3 ± 11.9 months). Functional outcomes were assessed using the Karlsson-Peterson and Tegner activity level scoring systems. Anterior talar translation (ATT), talar tilt angle (TTA), and degrees of displacement of the calcaneus against the talus on stress radiographs were measured. All parameters were compared between the two groups. Multiple regression analysis setting the postoperative Karlsson-Peterson score as the dependent variable was performed to determine the significant variable.
RESULTS


There were no significant differences between the two groups in functional (Karlsson-Peterson and Tegner activity level) scores at the last follow-up and their changes. There were no significant differences between the two groups in the ATT, TTA, their differences compared with the contralateral ankles, and degrees of displacement of the calcaneus against the talus at the last follow-up. Osteochondral lesion of the talus rather than CFL repair was the significant variable related to functional outcome.
CONCLUSION


The modified Broström procedure with additional CFL repair did not result in a significant advantage in any measured outcome at 3 years.
LEVEL OF EVIDENCE


Randomized controlled trial, Level I.",2020,"There were no significant differences between the two groups in the ATT, TTA, their differences compared with the contralateral ankles, and degrees of displacement of the calcaneus against the talus at the last follow-up.","['2\xa0years (CFL group: 22 patients, 36.6\u2009±\u200913.1\xa0months; ATFL Only group: 21 patients, 35.3\u2009±\u200911.9\xa0months', '50 patients randomly assigned to two groups, 43 were followed up prospectively for ≥']","['modified Broström procedure with [calcaneofibular ligament (CFL', 'CFL repair [anterior talofibular ligament (ATFL']","['functional (Karlsson-Peterson and Tegner activity level) scores', 'postoperative Karlsson-Peterson score', 'Anterior talar translation (ATT), talar tilt angle (TTA), and degrees of displacement of the calcaneus against the talus on stress radiographs', 'Karlsson-Peterson and Tegner activity level scoring systems']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0225168', 'cui_str': 'Calcaneofibular Ligament'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0225166', 'cui_str': 'Structure of anterior talofibular ligament'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C3850078', 'cui_str': 'Tegner Activity Scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0231769', 'cui_str': 'Talar tilt (finding)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0039277', 'cui_str': 'Astragalus Bone'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C1306645', 'cui_str': 'Plain x-ray'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]",50.0,0.0717266,"There were no significant differences between the two groups in the ATT, TTA, their differences compared with the contralateral ankles, and degrees of displacement of the calcaneus against the talus at the last follow-up.","[{'ForeName': 'Kyung Rae', 'Initials': 'KR', 'LastName': 'Ko', 'Affiliation': 'Department of Orthopedic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-Ro, Gangnam-gu, Seoul, 06351, South Korea.'}, {'ForeName': 'Won-Young', 'Initials': 'WY', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopedic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-Ro, Gangnam-gu, Seoul, 06351, South Korea.'}, {'ForeName': 'Hyobeom', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopedic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-Ro, Gangnam-gu, Seoul, 06351, South Korea.'}, {'ForeName': 'Hee Seol', 'Initials': 'HS', 'LastName': 'Park', 'Affiliation': 'Department of Orthopedic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-Ro, Gangnam-gu, Seoul, 06351, South Korea.'}, {'ForeName': 'Ki-Sun', 'Initials': 'KS', 'LastName': 'Sung', 'Affiliation': 'Department of Orthopedic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-Ro, Gangnam-gu, Seoul, 06351, South Korea. kissung@gmail.com.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-018-5091-3']
1518,30071142,Randomised study of children with obesity showed that whole body vibration reduced sclerostin.,"AIM


New strategies are required to increase physical activity and improve metabolic profiles in children with obesity. We studied the effect of whole body vibration (WBV) on children with obesity on biochemical markers of energy and bone metabolism, anthropometric measurements, muscle parameters and calcaneal bone mineral density (BMD).
METHODS


This was a randomised, prospective, controlled study of 30 children with a median age of 13 years (range 7-17) at Queen Silvia Children's Hospital, Gothenburg, Sweden, from 2013 to 2015. The target for the intervention group was to perform WBV three times a week for 12 weeks, and the study parameters were assessed at baseline and 12 weeks.
RESULTS


The 16 in the WBV group achieved 51% of the planned activity, mainly at home, and were compared with 14 controls. Sclerostin, bone-specific alkaline phosphatase and carboxy-terminal collagen cross-links decreased in the WBV group (p < 0.05) and balance improved (p < 0.006), but osteocalcin and insulin remained unchanged. Anthropometric data, muscle strength and calcaneal BMD did not differ between the groups.
CONCLUSION


WBV did not affect most of the clinical parameters in children with obesity, but the reduction in sclerostin implies that it had direct effects on osteocytes, which are key players in bone mechanotransduction.",2019,"Sclerostin, bone-specific alkaline phosphatase and carboxy-terminal collagen cross-links decreased in the WBV group (p < 0.05) and balance improved (p < 0.006), but osteocalcin and insulin remained unchanged.","['children with obesity', 'children with obesity on', ""30 children with a median age of 13 years (range 7-17) at Queen Silvia Children's Hospital, Gothenburg, Sweden, from 2013 to 2015""]",['whole body vibration (WBV'],"['Anthropometric data, muscle strength and calcaneal BMD', 'biochemical markers of energy and bone metabolism, anthropometric measurements, muscle parameters and calcaneal bone mineral density (BMD', 'osteocalcin and insulin', 'Sclerostin, bone-specific alkaline phosphatase and carboxy-terminal collagen cross-links']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Marker'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0002059', 'cui_str': 'Orthophosphoric-monoester phosphohydrolase (alkaline optimum)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}]",30.0,0.0220556,"Sclerostin, bone-specific alkaline phosphatase and carboxy-terminal collagen cross-links decreased in the WBV group (p < 0.05) and balance improved (p < 0.006), but osteocalcin and insulin remained unchanged.","[{'ForeName': 'Bojan', 'Initials': 'B', 'LastName': 'Tubic', 'Affiliation': ""Department of Pediatrics, Institute of Clinical Sciences, Sahlgrenska Academy, The Queen Silvia Children's Hospital, Gothenburg University, Gothenburg, Sweden.""}, {'ForeName': 'Rickard', 'Initials': 'R', 'LastName': 'Zeijlon', 'Affiliation': 'Department of Internal Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Göran', 'Initials': 'G', 'LastName': 'Wennergren', 'Affiliation': ""Department of Pediatrics, Institute of Clinical Sciences, Sahlgrenska Academy, The Queen Silvia Children's Hospital, Gothenburg University, Gothenburg, Sweden.""}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Obermayer-Pietsch', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Staffan', 'Initials': 'S', 'LastName': 'Mårild', 'Affiliation': ""Department of Pediatrics, Institute of Clinical Sciences, Sahlgrenska Academy, The Queen Silvia Children's Hospital, Gothenburg University, Gothenburg, Sweden.""}, {'ForeName': 'Jovanna', 'Initials': 'J', 'LastName': 'Dahlgren', 'Affiliation': ""Department of Pediatrics, Institute of Clinical Sciences, Sahlgrenska Academy, The Queen Silvia Children's Hospital, Gothenburg University, Gothenburg, Sweden.""}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Magnusson', 'Affiliation': 'Department of Clinical Chemistry, Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Swolin-Eide', 'Affiliation': ""Department of Pediatrics, Institute of Clinical Sciences, Sahlgrenska Academy, The Queen Silvia Children's Hospital, Gothenburg University, Gothenburg, Sweden.""}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.14531']
1519,30009636,Effect of a Virtual Reality-Based Exercise Program on Fatigue in Hospitalized Taiwanese End-Stage Renal Disease Patients Undergoing Hemodialysis.,"The purpose of this study was to evaluate the short-term effect of a virtual reality-based exercise program on fatigue in patients with end-stage renal disease (ESRD) who receive hemodialysis (HD). In this quasi-experimental study design, an experimental group ( n  = 32) received virtual reality training that promoted exercise, and a control group ( n  = 32) received routine care (advice on physical activities). Fatigue and physiologic parameters were assessed pretest (before intervention) as well as posttest (4 weeks after the onset of intervention). Our results showed that patients in the experimental group had significantly lower levels of overall fatigue, reduction in vigor and motivation, distress and loss of control in mood, and higher hemoglobin levels compared with the control group. ANCOVA revealed that there were no differences in overall fatigue and different domains of fatigue. Exercise only increased the blood urea nitrogen (BUN) and creatinine levels significantly in the intervention group.",2020,"Our results showed that patients in the experimental group had significantly lower levels of overall fatigue, reduction in vigor and motivation, distress and loss of control in mood, and higher hemoglobin levels compared with the control group.","['Hospitalized Taiwanese End-Stage Renal Disease Patients Undergoing Hemodialysis', 'patients with end-stage renal disease (ESRD) who receive hemodialysis (HD']","['virtual reality training that promoted exercise, and a control group', 'routine care (advice on physical activities', 'virtual reality-based exercise program', 'Virtual Reality-Based Exercise Program']","['overall fatigue and different domains of fatigue', 'Fatigue and physiologic parameters', 'blood urea nitrogen (BUN) and creatinine levels', 'overall fatigue, reduction in vigor and motivation, distress and loss of control in mood, and higher hemoglobin levels']","[{'cui': 'C1556096', 'cui_str': 'Taiwanese (ethnic group)'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0600137', 'cui_str': 'Blood urea nitrogen (substance)'}, {'cui': 'C0428279', 'cui_str': 'Finding of creatinine level (finding)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0182438,"Our results showed that patients in the experimental group had significantly lower levels of overall fatigue, reduction in vigor and motivation, distress and loss of control in mood, and higher hemoglobin levels compared with the control group.","[{'ForeName': 'Hsiao-Yu', 'Initials': 'HY', 'LastName': 'Chou', 'Affiliation': 'Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Shu-Ching', 'Initials': 'SC', 'LastName': 'Chen', 'Affiliation': 'Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Tzung-Hai', 'Initials': 'TH', 'LastName': 'Yen', 'Affiliation': 'Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Hui-Mei', 'Initials': 'HM', 'LastName': 'Han', 'Affiliation': 'Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}]",Clinical nursing research,['10.1177/1054773818788511']
1520,31644793,A Noninferiority Randomized Clinical Trial of the Use of the Smartphone-Based Health Applications IBDsmart and IBDoc in the Care of Inflammatory Bowel Disease Patients.,"BACKGROUND


Providing timely follow-up care for patients with inflammatory bowel disease in remission is important but often difficult because of resource limitations. Using smartphones to communicate symptoms and biomarkers is a potential alternative. We aimed to compare outpatient management using 2 smartphone apps (IBDsmart for symptoms and IBDoc for fecal calprotectin monitoring) vs standard face-to-face care. We hypothesized noninferiority of quality of life and symptoms at 12 months plus a reduction in face-to-face appointments in the smartphone app group.
METHODS


Inflammatory bowel disease outpatients (previously seen more often than annually) were randomized to smartphone app or standard face-to-face care over 12 months. Quality of life and symptoms were measured quarterly for 12 months. Acceptability was measured for gastroenterologists and patients at 12 months.
RESULTS


One hundred people (73 Crohn's disease, 49 male, average age 35 years) consented and completed baseline questionnaires (50 in each group). Intention-to-treat and per-protocol analyses revealed noninferiority of quality of life and symptom scores at 12 months. Outpatient appointment numbers were reduced in smartphone app care (P < 0.001). There was no difference in number of surgical outpatient appointments or number of disease-related hospitalizations between groups. Adherence to IBDsmart (50% perfect adherence) was slightly better than adherence to IBDoc (30% perfect adherence). Good acceptability was reported among most gastroenterologists and patients.
CONCLUSIONS


Remote symptom and fecal calprotectin monitoring is effective and acceptable. It also reduces the need for face-to-face outpatient appointments. Patients with mild-to-moderate disease who are not new diagnoses are ideal for this system.
CLINICAL TRIAL REGISTRATION NUMBER


ACTRN12615000342516.",2020,Intention-to-treat and per-protocol analyses revealed noninferiority of quality of life and symptom scores at 12 months.,"['Inflammatory Bowel Disease Patients', ""One hundred people (73 Crohn's disease, 49 male, average age 35 years) consented and completed baseline questionnaires (50 in each group"", 'Patients with mild-to-moderate disease who are not new diagnoses', 'Inflammatory bowel disease outpatients (previously seen more often than annually', 'patients with inflammatory bowel disease in remission']","['Smartphone-Based Health Applications IBDsmart and IBDoc', 'smartphone app or standard face-to-face care over 12 months']","['Quality of life and symptoms', 'number of surgical outpatient appointments or number of disease-related hospitalizations', 'noninferiority of quality of life and symptom scores', 'Good acceptability', 'Acceptability', 'quality of life and symptoms']","[{'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2585997', 'cui_str': 'New diagnosis (observable entity)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0034380'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",49.0,0.141314,Intention-to-treat and per-protocol analyses revealed noninferiority of quality of life and symptom scores at 12 months.,"[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McCombie', 'Affiliation': 'University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Walmsley', 'Affiliation': 'University of Auckland and Department of Gastroenterology, Waitemata District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Murray', 'Initials': 'M', 'LastName': 'Barclay', 'Affiliation': 'University of Otago and Department of Gastroenterology, Canterbury District Health Board, Christchurch, New Zealand.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Ho', 'Affiliation': 'Department of Gastroenterology, Southern District Health Board, Dunedin, New Zealand.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Langlotz', 'Affiliation': 'Department of Information Science, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Regenbrecht', 'Affiliation': 'Department of Gastroenterology, Southern District Health Board, Dunedin, New Zealand.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Gray', 'Affiliation': 'Centre for Biostatistics, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Nideen', 'Initials': 'N', 'LastName': 'Visesio', 'Affiliation': 'Department of Gastroenterology, Waitemata District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Inns', 'Affiliation': 'Department of Medicine, University of Otago, Wellington, New Zealand and Department of Gastroenterology, Hutt Valley District Health Board, Lower Hutt, New Zealand.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schultz', 'Affiliation': 'Department of Medicine, University of Otago, and Department of Gastroenterology, Southern District Health Board, Dunedin, New Zealand.'}]",Inflammatory bowel diseases,['10.1093/ibd/izz252']
1521,31647379,Communicating Dynamic Behaviors in Basketball: The Role of Verbal Instructions and Arrow Symbols.,"Purpose:  Guided by cognitive load theory and cognitive theory of multimedia learning, the purpose of this study was to evaluate players' ability to integrate dynamic information presented under different conditions: a verbal condition, in which instructions were given orally; a visual condition, in which instructions were shown using arrow symbols; and a redundant condition, in which both visual and verbal instructions were presented simultaneously.  Method:  In a 2 × 3 design, we asked basketball players with varied levels of skill (less-skilled, skilled) to rate their invested mental effort and to perform a recall test after learning from either the verbal, visual or redundant condition.  Results:  Results demonstrated that the less-skilled players benefited more from the redundant condition, whereas the skilled participants benefited more from the visual condition.  Conclusion:  Recommendations for improving instructional design techniques aimed at the transmission of tactical instructions in team games are proposed.",2020,"Results demonstrated that the less-skilled players benefited more from the redundant condition, whereas the skilled participants benefited more from the visual condition.  ",['Basketball'],"['basketball players with varied levels of skill (less-skilled, skilled) to rate their invested mental effort and to perform a recall test after learning from either the verbal, visual or redundant condition', 'cognitive load theory and cognitive theory of multimedia learning']",[],"[{'cui': 'C0004818', 'cui_str': 'Basketball'}]","[{'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0376478', 'cui_str': 'Multimedium'}]",[],,0.0237597,"Results demonstrated that the less-skilled players benefited more from the redundant condition, whereas the skilled participants benefited more from the visual condition.  ","[{'ForeName': 'Aïmen', 'Initials': 'A', 'LastName': 'Khacharem', 'Affiliation': 'Paris-East Créteil University.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Trabelsi', 'Affiliation': 'University of Sfax.'}, {'ForeName': 'Bachir', 'Initials': 'B', 'LastName': 'Zoudji', 'Affiliation': 'University of Polytechnique Hautes-de-France.'}, {'ForeName': 'Slava', 'Initials': 'S', 'LastName': 'Kalyuga', 'Affiliation': 'University of New South Wales.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2019.1657553']
1522,30861139,Long-term evaluation of satisfaction and side effects after modified uvulopalatopharyngoplasty.,"OBJECTIVES/HYPOTHESIS


We have previously shown that modified uvulopalatopharyngoplasty (UPPP) is effective to treat obstructive sleep apnea (OSA) and that the effect is stable after 24 months. This continuous report includes questionnaires and phone interviews.
STUDY DESIGN


Prospective intervention study.
METHODS


Sixty-five patients with apnea-hypopnea index (AHI) score ≥ 15, body mass index <36 kg/m 2  , and Epworth Sleepiness Scale (ESS) score ≥ 8 underwent modified UPPP after failing nonsurgical treatment. The results from a patient questionnaire at 6 and 24 months after surgery were correlated with age, body mass index, and ESS and AHI scores. Patients reporting side effects and/or regretting the surgery after 24 months were selected for phone interviews 9 years after surgery.
RESULTS


The response rate was 80% and 74% at the 6- and 24-month follow-ups, respectively. Of those who responded to the questionnaire, 96% and 83% were satisfied after 6 and 24 months, respectively; 98% and 92% recommended the surgery. Side effects (globus, mucus, and voice and swallowing disorders) occurred in 38% and 31%, respectively. Dissatisfaction correlated significantly with high postoperative AHI and ESS scores, but not with occurrence of side effects. Younger subjects had a higher rate of recommendation and lower rate of side effects than did older subjects. Phone interviews after 9 years were responded to by 14 of 16 selected patients, and the responders reported minor or no side effects.
CONCLUSIONS


The vast majority of the OSA patients were satisfied 24 months after surgery, even though a third of them were experiencing side effects. Younger patients had fewer side effects than did older patients. Patients with better OSA outcomes were also more satisfied. After 9 years the side effects were no longer problematic.
LEVEL OF EVIDENCE


2b Laryngoscope, 130:263-268, 2020.",2020,"Side effects (globus, mucus, and voice and swallowing disorders) occurred in 38% and 31%, respectively.","['Sixty-five patients with apnea-hypopnea index (AHI) score\u2009≥\u200915, body mass index <36\u2009kg/m 2  , and Epworth Sleepiness Scale (ESS) score\u2009≥\u20098 underwent modified UPPP after failing nonsurgical treatment', 'Younger patients', 'Younger subjects']","['modified uvulopalatopharyngoplasty (UPPP', 'modified uvulopalatopharyngoplasty']","['side effects', 'Side effects (globus, mucus, and voice and swallowing disorders', 'response rate', 'rate of recommendation and lower rate of side effects']","[{'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4706348', 'cui_str': 'Epworth Sleepiness Scale score (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1535578', 'cui_str': 'Uvulopalatopharyngoplasty (procedure)'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0026727', 'cui_str': 'Mucus'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",65.0,0.032432,"Side effects (globus, mucus, and voice and swallowing disorders) occurred in 38% and 31%, respectively.","[{'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Friberg', 'Affiliation': 'Department of Surgical Sciences, Otorhinolaryngology-Head and Neck Surgery, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Joar', 'Initials': 'J', 'LastName': 'Sundman', 'Affiliation': 'Department of Clinical Sciences, Intervention, and Technology, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Nanna', 'Initials': 'N', 'LastName': 'Browaldh', 'Affiliation': 'Department of Clinical Sciences, Intervention, and Technology, Karolinska Institute, Stockholm, Sweden.'}]",The Laryngoscope,['10.1002/lary.27917']
1523,30010835,A web-based dietary intervention in early pregnancy and neonatal outcomes: a randomized controlled trial.,"BACKGROUND


Maternal nutrition is a determinant of pregnancy outcomes. Few studies have evaluated the potential of online nutrition resources to modify behaviour. This randomized controlled trial aimed to determine whether access to a customized evidence-based nutrition website in pregnancy improved neonatal outcomes.
METHODS


Women <18 weeks gestation were recruited at their convenience. The control group received standard care. In addition to standard care, the intervention group received access to an evidence-based nutrition website, customized to the preferences of pregnant women.
RESULTS


Of the 250 women, there were no differences in characteristics between the two groups. Of the women, 91.0% reported they make a conscious effort currently to eat a healthy diet. However, only 19.6% met dietary requirements for calcium, 13.2% for iron, 2.7% for folate and 2.3% for iodine. The most popular website section was pregnancy nutrition advice but engagement was not sustained. Access to the website was not associated with any improvement in clinical outcomes (P > 0.05).
CONCLUSIONS


We found that provision of a customized website providing nutrition information, did not improve neonatal outcomes. Future studies should explore whether redesign with website interactivity or embedding information on popular digital platforms sustains women's engagement and modifies dietary behaviour.",2019,"Access to the website was not associated with any improvement in clinical outcomes (P > 0.05).
","['250 women', 'Methods\n\n\nWomen <18 weeks gestation were recruited at their convenience']","['customized evidence-based nutrition website', 'A web-based dietary intervention', 'standard care']","['clinical outcomes', 'neonatal outcomes']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}]",250.0,0.170891,"Access to the website was not associated with any improvement in clinical outcomes (P > 0.05).
","[{'ForeName': 'R A K', 'Initials': 'RAK', 'LastName': 'Kennedy', 'Affiliation': 'UCD Centre for Human Reproduction, Coombe Women and Infants University Hospital, Cork Street, Dublin 8, Ireland.'}, {'ForeName': 'C M E', 'Initials': 'CME', 'LastName': 'Reynolds', 'Affiliation': 'UCD Centre for Human Reproduction, Coombe Women and Infants University Hospital, Cork Street, Dublin 8, Ireland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cawley', 'Affiliation': 'UCD Centre for Human Reproduction, Coombe Women and Infants University Hospital, Cork Street, Dublin 8, Ireland.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': ""O'Malley"", 'Affiliation': 'UCD Centre for Human Reproduction, Coombe Women and Infants University Hospital, Cork Street, Dublin 8, Ireland.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'McCartney', 'Affiliation': 'School of Biological Sciences, Dublin Institute of Technology, Kevin Street, Dublin 8, Ireland.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Turner', 'Affiliation': 'UCD Centre for Human Reproduction, Coombe Women and Infants University Hospital, Cork Street, Dublin 8, Ireland.'}]","Journal of public health (Oxford, England)",['10.1093/pubmed/fdy117']
1524,31647384,Long-Term Effects in the EXERDIET-HTA Study: Supervised Exercise Training  vs . Physical Activity Advice.,"Purpose : To determine whether improvements in cardiorespiratory fitness (CRF), blood pressure (BP) and body composition previously seen after a 16-week exercise intervention (POST) with hypocaloric diet are maintained following six months (6M) of unsupervised exercise time.  Methods : Overweight/obese, physically inactive participants with primary hypertension (HTN) (n = 190) were randomly assigned into an attention control group (physical activity recommendations) or one of three supervised exercise groups. After POST, all participants received diet and physical activity advice for the following 6M but no supervision. All anthropometric and physiological measurements were taken pre and post the 16-week supervised intervention period, as well as after 6M of no supervision.  Results : After 6M: 1) body mass (BM) (Δ = 2.5%) and waist circumference (Δ = 1.8%) were higher ( P  < .005) than POST, but lower ( P  < .005) than pre-intervention (BM, Δ = -5.1%; waist circumference, Δ = -4.7%), with high-volume and high-intensity interval training group revealing a higher BM reduction (Δ = -6.4 kg) compared to control group (Δ = -3.5 kg); 2) BP variables were higher ( P  < .001) compared to POST with no change from pre-intervention; and 3) CRF was higher compared to pre-intervention (Δ = 17.1%,  P  < .001) but lower than POST (Δ = -5.7%,  P  < .001).  Conclusions : When an overweight/obese population with HTN attains significant improvements in cardiometabolic health POST intervention with diet restriction, there is a significant reduction following 6M when exercise and diet supervision is removed, and only recommendations were applied. These results suggest the need for a regular, systematic and supervised diet and exercise programs to avoid subsequent declines in cardiometabolic health.",2020,"P  < .001) compared to POST with no change from pre-intervention; and 3) CRF was higher compared to pre-intervention (Δ = 17.1%,  P  < .001) but lower than POST (","['Overweight/obese, physically inactive participants with primary hypertension (HTN) (n = 190']","['attention control group (physical activity recommendations) or one of three supervised exercise groups', 'Supervised Exercise Training  vs ', 'exercise intervention (POST) with hypocaloric diet']","['BM reduction', 'waist circumference', 'Physical Activity Advice', 'cardiorespiratory fitness (CRF), blood pressure (BP) and body composition']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0085580', 'cui_str': 'Essential Hypertension'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}]",,0.0224371,"P  < .001) compared to POST with no change from pre-intervention; and 3) CRF was higher compared to pre-intervention (Δ = 17.1%,  P  < .001) but lower than POST (","[{'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Corres', 'Affiliation': 'University of the Basque Country (UPV/EHU).'}, {'ForeName': 'Aitor', 'Initials': 'A', 'LastName': 'MartinezAguirre-Betolaza', 'Affiliation': 'University of the Basque Country (UPV/EHU).'}, {'ForeName': 'Simon M', 'Initials': 'SM', 'LastName': 'Fryer', 'Affiliation': 'University of Gloucestershire.'}, {'ForeName': 'Ilargi', 'Initials': 'I', 'LastName': 'Gorostegi-Anduaga', 'Affiliation': 'University of the Basque Country (UPV/EHU).'}, {'ForeName': 'Iñaki', 'Initials': 'I', 'LastName': 'Arratibel-Imaz', 'Affiliation': 'University of the Basque Country (UPV/EHU).'}, {'ForeName': 'G Rodrigo', 'Initials': 'GR', 'LastName': 'Aispuru', 'Affiliation': 'Igualatorio Médico Quirúrgico (IMQ-Amárica).'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Maldonado-Martín', 'Affiliation': 'University of the Basque Country (UPV/EHU).'}]",Research quarterly for exercise and sport,['10.1080/02701367.2019.1656794']
1525,30095153,Feasibility of Weighted Vest Use during a Dietary Weight Loss Intervention and Effects on Body Composition and Physical Function in Older Adults.,"BACKGROUND


While intentional weight loss in older adults with obesity yields clinically important health benefits there is a need to minimize the negative effects of weight loss on concomitant loss of muscle mass and strength. Data show wearing weighted vests during exercise improves lean mass and lower extremity strength, however the efficacy of wearing a weighted vest during a period of weight loss to mitigate muscle and strength loss is not known.
OBJECTIVES


This study examined the feasibility of daily weighted vest use during a dietary weight loss intervention, and examined effects of vest use on body composition and physical function in well-functioning older adults with obesity.
DESIGN


Randomized, controlled pilot study.
SETTING


Wake Forest Baptist Medical Center in Winston-Salem, NC.
PARTICIPANTS


37 older (age=65-79 yrs), obese (BMI=30-40 kg/ m2) sedentary men and women.
INTERVENTIONS


22-week behavioral diet intervention (targeting 10% weight loss, 1100-1300 kcals/day) with (Diet+Vest; n=20) or without (Diet; n=17) weighted vest use (goal of 10 hours/ day with weight added weekly according to individual loss of body mass).
MEASUREMENTS


Body composition by dual-energy x-ray absorptiometry and measures of physical function, mobility, and muscle strength/power.
RESULTS


Average weighted vest use was 6.7±2.2 hours/day and the vest-wear goal of 10 hrs/day was achieved for 67±22% of total intervention days. Five participants reported adverse events from wearing the vest (all back pain or soreness). Both groups lost a similar amount of weight (Diet= -11.2±4.4 kg; Diet+Vest = -11.0±6.3 kg; p<0.001), with no differences between groups (p=0.25). Fat mass, lean mass, and % body fat decreased significantly (p<0.0001), with no differences between groups. Compared to Diet+Vest, the Diet intervention resulted in greater decreases in leg power (p<0.02), with no other between group differences in physical function.
CONCLUSION


This pilot study showed that vest use during dietary weight loss is feasible and safe in well-functioning older adults with obesity. Larger studies are needed to definitively determine whether external replacement of lost weight during caloric restriction may preserve lower extremity muscle strength and power.",2018,"Compared to Diet+Vest, the Diet intervention resulted in greater decreases in leg power (p<0.02), with no other between group differences in physical function.
","['37 older (age=65-79 yrs), obese (BMI=30-40 kg/ m2) sedentary men and women', 'well-functioning older adults with obesity', 'Older Adults', 'older adults with obesity yields clinically important health benefits', 'Wake Forest Baptist Medical Center in Winston-Salem, NC']","['vest use during dietary weight loss', '22-week behavioral diet intervention', 'Weighted Vest Use during a Dietary Weight Loss Intervention', 'daily weighted vest use during a dietary weight loss intervention']","['Fat mass, lean mass, and % body fat', 'physical function', 'Body composition by dual-energy x-ray absorptiometry and measures of physical function, mobility, and muscle strength/power', 'adverse events', 'lean mass and lower extremity strength', 'leg power', 'Body Composition and Physical Function', 'body composition and physical function']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086387', 'cui_str': 'Health Benefits'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C0086312', 'cui_str': 'Forestlands'}, {'cui': 'C0425343', 'cui_str': 'Baptist, follower of religion (person)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}]","[{'cui': 'C0453884', 'cui_str': 'Waistcoat'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]",,0.0419847,"Compared to Diet+Vest, the Diet intervention resulted in greater decreases in leg power (p<0.02), with no other between group differences in physical function.
","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Normandin', 'Affiliation': 'Barbara J. Nicklas, Ph.D. Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, USA, Phone: (336) 713-8569, Fax: (336) 713-8588, e-mail: bnicklas@wakehealth.edu.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Yow', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Crotts', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kiel', 'Affiliation': ''}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Beavers', 'Affiliation': ''}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Nicklas', 'Affiliation': ''}]",The Journal of frailty & aging,['10.14283/jfa.2018.17']
1526,31680395,"A randomized, patient/evaluator-blinded, split-face study to compare the efficacy and safety of polycaprolactone and polynucleotide fillers in the correction of crow's feet: The latest biostimulatory dermal filler for crow's feet.","BACKGROUND


No data on the clinical results and safety profiles of the polycaprolactone (PCL) -based dermal filler for crow's feet correction have been published.
AIMS


This study was designed to compare the efficacy and safety of a novel PCL-based dermal filler, DLMR01, with that of RJR, a purified polynucleotide dermal filler.
PATIENTS/METHODS


A total of 30 subjects with symmetric crow's feet of 2-4 points on the Crow's Feet Grading Scale (CFGS) were enrolled in this randomized, patient/evaluator-blinded, split-face study. Each subject was randomized to receive injections of DLMR01 or RJR in their right or left crow's feet. At 4 and 12 weeks, all participants were evaluated via CFGS, Global Aesthetic Improvement Scale (GAIS), and PRIMOS software system.
RESULTS


No significant difference in CFGS, GAIS, and R a  value was detected between DLMR01 side and RJR at 12 weeks (improvement rate in CFGS from baseline at week 12-DLMR01: 48.28% [14/29], RJR: 41.38% [12/29]).
CONCLUSION


The novel PCL-based dermal filler DLMR01 shows suitable efficacy and safety, widening the selection possibilities for clinicians and patients in the treatment crow's feet.",2020,"No significant difference in CFGS, GAIS, and R a  value was detected between DLMR01 side and RJR at 12 weeks (improvement rate in CFGS from baseline at week 12-DLMR01: 48.28% [14/29], RJR: 41.38% [12/29]).
","[""30 subjects with symmetric crow's feet of 2-4 points on the Crow's Feet Grading Scale (CFGS"", ""crow's feet""]","['DLMR01 or RJR', 'polycaprolactone (PCL) -based dermal filler', 'polycaprolactone and polynucleotide fillers', 'novel PCL-based dermal filler, DLMR01, with that of RJR']","['via CFGS, Global Aesthetic Improvement Scale (GAIS), and PRIMOS software system', 'efficacy and safety', 'CFGS, GAIS, and R a  value']","[{'cui': 'C0277939', 'cui_str': ""Crow's feet (finding)""}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0222045'}]","[{'cui': 'C0137734', 'cui_str': 'polycaprolactone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4042850', 'cui_str': 'Skin Fillers'}, {'cui': 'C0032550', 'cui_str': 'Polynucleotides'}, {'cui': 'C0729441', 'cui_str': 'Filler (substance)'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C0222045'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",30.0,0.0511324,"No significant difference in CFGS, GAIS, and R a  value was detected between DLMR01 side and RJR at 12 weeks (improvement rate in CFGS from baseline at week 12-DLMR01: 48.28% [14/29], RJR: 41.38% [12/29]).
","[{'ForeName': 'Guk Jin', 'Initials': 'GJ', 'LastName': 'Jeong', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Ga Ram', 'Initials': 'GR', 'LastName': 'Ahn', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Su Jung', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Ji Yeon', 'Initials': 'JY', 'LastName': 'Hong', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Beom Joon', 'Initials': 'BJ', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13199']
1527,30067931,Four Months of Rifampin or Nine Months of Isoniazid for Latent Tuberculosis in Adults.,"BACKGROUND


A 9-month regimen of isoniazid can prevent active tuberculosis in persons with latent tuberculosis infection. However, the regimen has been associated with poor adherence rates and with toxic effects.
METHODS


In an open-label trial conducted in nine countries, we randomly assigned adults with latent tuberculosis infection to receive treatment with a 4-month regimen of rifampin or a 9-month regimen of isoniazid for the prevention of confirmed active tuberculosis within 28 months after randomization. Noninferiority and potential superiority were assessed. Secondary outcomes included clinically diagnosed active tuberculosis, adverse events of grades 3 to 5, and completion of the treatment regimen. Outcomes were adjudicated by independent review panels.
RESULTS


Among the 3443 patients in the rifampin group, confirmed active tuberculosis developed in 4 and clinically diagnosed active tuberculosis developed in 4 during 7732 person-years of follow-up, as compared with 4 and 5 patients, respectively, among 3416 patients in the isoniazid group during 7652 person-years of follow-up. The rate differences (rifampin minus isoniazid) were less than 0.01 cases per 100 person-years (95% confidence interval [CI], -0.14 to 0.16) for confirmed active tuberculosis and less than 0.01 cases per 100 person-years (95% CI, -0.23 to 0.22) for confirmed or clinically diagnosed tuberculosis. The upper boundaries of the 95% confidence interval for the rate differences of the confirmed cases and for the confirmed or clinically diagnosed cases of tuberculosis were less than the prespecified noninferiority margin of 0.75 percentage points in cumulative incidence; the rifampin regimen was not superior to the isoniazid regimen. The difference in the treatment-completion rates was 15.1 percentage points (95% CI, 12.7 to 17.4). The rate differences for adverse events of grade 3 to 5 occurring within 146 days (120% of the 4-month planned duration of the rifampin regimen) were -1.1 percentage points (95% CI, -1.9 to -0.4) for all events and -1.2 percentage points (95% CI, -1.7 to -0.7) for hepatotoxic events.
CONCLUSIONS


The 4-month regimen of rifampin was not inferior to the 9-month regimen of isoniazid for the prevention of active tuberculosis and was associated with a higher rate of treatment completion and better safety. (Funded by the Canadian Institutes of Health Research and the Australian National Health and Medical Research Council; ClinicalTrials.gov number, NCT00931736 .).",2018,"The rate differences (rifampin minus isoniazid) were less than 0.01 cases per 100 person-years (95% confidence interval [CI], -0.14 to 0.16) for confirmed active tuberculosis and less than 0.01 cases per 100 person-years (95% CI, -0.23 to 0.22) for confirmed or clinically diagnosed tuberculosis.","['3443 patients in the', 'Latent Tuberculosis in Adults', 'persons with latent tuberculosis infection']","['rifampin', 'isoniazid', 'Isoniazid', 'Rifampin']","['rate differences (rifampin minus isoniazid', 'clinically diagnosed active tuberculosis, adverse events of grades 3 to 5, and completion of the treatment regimen', 'treatment-completion rates', 'diagnosed active tuberculosis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1609538', 'cui_str': 'Latent Tuberculosis Infection'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}]","[{'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C0332288', 'cui_str': 'Without (attribute)'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0151332', 'cui_str': 'Active tuberculosis (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.439651,"The rate differences (rifampin minus isoniazid) were less than 0.01 cases per 100 person-years (95% confidence interval [CI], -0.14 to 0.16) for confirmed active tuberculosis and less than 0.01 cases per 100 person-years (95% CI, -0.23 to 0.22) for confirmed or clinically diagnosed tuberculosis.","[{'ForeName': 'Dick', 'Initials': 'D', 'LastName': 'Menzies', 'Affiliation': 'From the Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill University Health Centre Research Institute (D.M., A.T., C.V., K.H., M.-J.D., P.Z.L., K.S., A.B.), and the Department of Epidemiology and Biostatistics (D.M., A.B.), McGill University, Montreal, the Faculty of Medicine and Dentistry, University of Alberta, Edmonton (R.L.), the Faculty of Medicine, University of Saskatchewan, Saskatoon (V.H.), and the BC Centre for Disease Control and the University of British Columbia, Vancouver (K.E., V.J.C.) - all in Canada; Centre National Hospitalier Universitaire de Pneumo-Phtisiologie, Cotonou, Benin (M.A., M.G.); the Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia (R.R., L.A., R.C.K.); State University of Rio de Janeiro (A.T.), Programa Academico de Tuberculose-Faculdade de Medicina, Universidade Federal do Rio de Janeiro-Rede TB (A.K.), and National Institute of Infectious Diseases Evandro Chagas (V.R.) - all in Rio de Janeiro; Service de Pneumophtisiologie, Hôpital National Ignace Deen, Université Gamal Abdel Nasser de Conakry, Conakry, Guinea (O.S., B.B., A.C.); Korean Institute of Tuberculosis, Seoul, South Korea (H.K.); Komfo Anokye Teaching Hospital, Kumasi, Ghana (J.O.B., I.B.); University of New South Wales (G.B.M.) and University of Sydney (H.G.), Sydney; Centre for International Health, University of Otago, Dunedin, New Zealand (P.C.H.); and the Department of Medicine, King Saud University, King Abdulaziz Medical City, Riyadh, Saudi Arabia (H.A.-J.).'}, {'ForeName': 'Menonli', 'Initials': 'M', 'LastName': 'Adjobimey', 'Affiliation': 'From the Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill University Health Centre Research Institute (D.M., A.T., C.V., K.H., M.-J.D., P.Z.L., K.S., A.B.), and the Department of Epidemiology and Biostatistics (D.M., A.B.), McGill University, Montreal, the Faculty of Medicine and Dentistry, University of Alberta, Edmonton (R.L.), the Faculty of Medicine, University of Saskatchewan, Saskatoon (V.H.), and the BC Centre for Disease Control and the University of British Columbia, Vancouver (K.E., V.J.C.) - all in Canada; Centre National Hospitalier Universitaire de Pneumo-Phtisiologie, Cotonou, Benin (M.A., M.G.); the Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia (R.R., L.A., R.C.K.); State University of Rio de Janeiro (A.T.), Programa Academico de Tuberculose-Faculdade de Medicina, Universidade Federal do Rio de Janeiro-Rede TB (A.K.), and National Institute of Infectious Diseases Evandro Chagas (V.R.) - all in Rio de Janeiro; Service de Pneumophtisiologie, Hôpital National Ignace Deen, Université Gamal Abdel Nasser de Conakry, Conakry, Guinea (O.S., B.B., A.C.); Korean Institute of Tuberculosis, Seoul, South Korea (H.K.); Komfo Anokye Teaching Hospital, Kumasi, Ghana (J.O.B., I.B.); University of New South Wales (G.B.M.) and University of Sydney (H.G.), Sydney; Centre for International Health, University of Otago, Dunedin, New Zealand (P.C.H.); and the Department of Medicine, King Saud University, King Abdulaziz Medical City, Riyadh, Saudi Arabia (H.A.-J.).'}, {'ForeName': 'Rovina', 'Initials': 'R', 'LastName': 'Ruslami', 'Affiliation': 'From the Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill University Health Centre Research Institute (D.M., A.T., C.V., K.H., M.-J.D., P.Z.L., K.S., A.B.), and the Department of Epidemiology and Biostatistics (D.M., A.B.), McGill University, Montreal, the Faculty of Medicine and Dentistry, University of Alberta, Edmonton (R.L.), the Faculty of Medicine, University of Saskatchewan, Saskatoon (V.H.), and the BC Centre for Disease Control and the University of British Columbia, Vancouver (K.E., V.J.C.) - all in Canada; Centre National Hospitalier Universitaire de Pneumo-Phtisiologie, Cotonou, Benin (M.A., M.G.); the Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia (R.R., L.A., R.C.K.); State University of Rio de Janeiro (A.T.), Programa Academico de Tuberculose-Faculdade de Medicina, Universidade Federal do Rio de Janeiro-Rede TB (A.K.), and National Institute of Infectious Diseases Evandro Chagas (V.R.) - all in Rio de Janeiro; Service de Pneumophtisiologie, Hôpital National Ignace Deen, Université Gamal Abdel Nasser de Conakry, Conakry, Guinea (O.S., B.B., A.C.); Korean Institute of Tuberculosis, Seoul, South Korea (H.K.); Komfo Anokye Teaching Hospital, Kumasi, Ghana (J.O.B., I.B.); University of New South Wales (G.B.M.) and University of Sydney (H.G.), Sydney; Centre for International Health, University of Otago, Dunedin, New Zealand (P.C.H.); and the Department of Medicine, King Saud University, King Abdulaziz Medical City, Riyadh, Saudi Arabia (H.A.-J.).'}, {'ForeName': 'Anete', 'Initials': 'A', 'LastName': 'Trajman', 'Affiliation': 'From the Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill University Health Centre Research Institute (D.M., A.T., C.V., K.H., M.-J.D., P.Z.L., K.S., A.B.), and the Department of Epidemiology and Biostatistics (D.M., A.B.), McGill University, Montreal, the Faculty of Medicine and Dentistry, University of Alberta, Edmonton (R.L.), the Faculty of Medicine, University of Saskatchewan, Saskatoon (V.H.), and the BC Centre for Disease Control and the University of British Columbia, Vancouver (K.E., V.J.C.) - all in Canada; Centre National Hospitalier Universitaire de Pneumo-Phtisiologie, Cotonou, Benin (M.A., M.G.); the Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia (R.R., L.A., R.C.K.); State University of Rio de Janeiro (A.T.), Programa Academico de Tuberculose-Faculdade de Medicina, Universidade Federal do Rio de Janeiro-Rede TB (A.K.), and National Institute of Infectious Diseases Evandro Chagas (V.R.) - all in Rio de Janeiro; Service de Pneumophtisiologie, Hôpital National Ignace Deen, Université Gamal Abdel Nasser de Conakry, Conakry, Guinea (O.S., B.B., A.C.); Korean Institute of Tuberculosis, Seoul, South Korea (H.K.); Komfo Anokye Teaching Hospital, Kumasi, Ghana (J.O.B., I.B.); University of New South Wales (G.B.M.) and University of Sydney (H.G.), Sydney; Centre for International Health, University of Otago, Dunedin, New Zealand (P.C.H.); and the Department of Medicine, King Saud University, King Abdulaziz Medical City, Riyadh, Saudi Arabia (H.A.-J.).'}, {'ForeName': 'Oumou', 'Initials': 'O', 'LastName': 'Sow', 'Affiliation': 'From the Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill University Health Centre Research Institute (D.M., A.T., C.V., K.H., M.-J.D., P.Z.L., K.S., A.B.), and the Department of Epidemiology and Biostatistics (D.M., A.B.), McGill University, Montreal, the Faculty of Medicine and Dentistry, University of Alberta, Edmonton (R.L.), the Faculty of Medicine, University of Saskatchewan, Saskatoon (V.H.), and the BC Centre for Disease Control and the University of British Columbia, Vancouver (K.E., V.J.C.) - all in Canada; Centre National Hospitalier Universitaire de Pneumo-Phtisiologie, Cotonou, Benin (M.A., M.G.); the Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia (R.R., L.A., R.C.K.); State University of Rio de Janeiro (A.T.), Programa Academico de Tuberculose-Faculdade de Medicina, Universidade Federal do Rio de Janeiro-Rede TB (A.K.), and National Institute of Infectious Diseases Evandro Chagas (V.R.) - all in Rio de Janeiro; Service de Pneumophtisiologie, Hôpital National Ignace Deen, Université Gamal Abdel Nasser de Conakry, Conakry, Guinea (O.S., B.B., A.C.); Korean Institute of Tuberculosis, Seoul, South Korea (H.K.); Komfo Anokye Teaching Hospital, Kumasi, Ghana (J.O.B., I.B.); University of New South Wales (G.B.M.) and University of Sydney (H.G.), Sydney; Centre for International Health, University of Otago, Dunedin, New Zealand (P.C.H.); and the Department of Medicine, King Saud University, King Abdulaziz Medical City, Riyadh, Saudi Arabia (H.A.-J.).'}, {'ForeName': 'Heejin', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'From the Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill University Health Centre Research Institute (D.M., A.T., C.V., K.H., M.-J.D., P.Z.L., K.S., A.B.), and the Department of Epidemiology and Biostatistics (D.M., A.B.), McGill University, Montreal, the Faculty of Medicine and Dentistry, University of Alberta, Edmonton (R.L.), the Faculty of Medicine, University of Saskatchewan, Saskatoon (V.H.), and the BC Centre for Disease Control and the University of British Columbia, Vancouver (K.E., V.J.C.) - all in Canada; Centre National Hospitalier Universitaire de Pneumo-Phtisiologie, Cotonou, Benin (M.A., M.G.); the Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia (R.R., L.A., R.C.K.); State University of Rio de Janeiro (A.T.), Programa Academico de Tuberculose-Faculdade de Medicina, Universidade Federal do Rio de Janeiro-Rede TB (A.K.), and National Institute of Infectious Diseases Evandro Chagas (V.R.) - all in Rio de Janeiro; Service de Pneumophtisiologie, Hôpital National Ignace Deen, Université Gamal Abdel Nasser de Conakry, Conakry, Guinea (O.S., B.B., A.C.); Korean Institute of Tuberculosis, Seoul, South Korea (H.K.); Komfo Anokye Teaching Hospital, Kumasi, Ghana (J.O.B., I.B.); University of New South Wales (G.B.M.) and University of Sydney (H.G.), Sydney; Centre for International Health, University of Otago, Dunedin, New Zealand (P.C.H.); and the Department of Medicine, King Saud University, King Abdulaziz Medical City, Riyadh, Saudi Arabia (H.A.-J.).'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Obeng Baah', 'Affiliation': 'From the Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill University Health Centre Research Institute (D.M., A.T., C.V., K.H., M.-J.D., P.Z.L., K.S., A.B.), and the Department of Epidemiology and Biostatistics (D.M., A.B.), McGill University, Montreal, the Faculty of Medicine and Dentistry, University of Alberta, Edmonton (R.L.), the Faculty of Medicine, University of Saskatchewan, Saskatoon (V.H.), and the BC Centre for Disease Control and the University of British Columbia, Vancouver (K.E., V.J.C.) - all in Canada; Centre National Hospitalier Universitaire de Pneumo-Phtisiologie, Cotonou, Benin (M.A., M.G.); the Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia (R.R., L.A., R.C.K.); State University of Rio de Janeiro (A.T.), Programa Academico de Tuberculose-Faculdade de Medicina, Universidade Federal do Rio de Janeiro-Rede TB (A.K.), and National Institute of Infectious Diseases Evandro Chagas (V.R.) - all in Rio de Janeiro; Service de Pneumophtisiologie, Hôpital National Ignace Deen, Université Gamal Abdel Nasser de Conakry, Conakry, Guinea (O.S., B.B., A.C.); Korean Institute of Tuberculosis, Seoul, South Korea (H.K.); Komfo Anokye Teaching Hospital, Kumasi, Ghana (J.O.B., I.B.); University of New South Wales (G.B.M.) and University of Sydney (H.G.), Sydney; Centre for International Health, University of Otago, Dunedin, New Zealand (P.C.H.); and the Department of Medicine, King Saud University, King Abdulaziz Medical City, Riyadh, Saudi Arabia (H.A.-J.).'}, {'ForeName': 'Guy B', 'Initials': 'GB', 'LastName': 'Marks', 'Affiliation': 'From the Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill University Health Centre Research Institute (D.M., A.T., C.V., K.H., M.-J.D., P.Z.L., K.S., A.B.), and the Department of Epidemiology and Biostatistics (D.M., A.B.), McGill University, Montreal, the Faculty of Medicine and Dentistry, University of Alberta, Edmonton (R.L.), the Faculty of Medicine, University of Saskatchewan, Saskatoon (V.H.), and the BC Centre for Disease Control and the University of British Columbia, Vancouver (K.E., V.J.C.) - all in Canada; Centre National Hospitalier Universitaire de Pneumo-Phtisiologie, Cotonou, Benin (M.A., M.G.); the Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia (R.R., L.A., R.C.K.); State University of Rio de Janeiro (A.T.), Programa Academico de Tuberculose-Faculdade de Medicina, Universidade Federal do Rio de Janeiro-Rede TB (A.K.), and National Institute of Infectious Diseases Evandro Chagas (V.R.) - all in Rio de Janeiro; Service de Pneumophtisiologie, Hôpital National Ignace Deen, Université Gamal Abdel Nasser de Conakry, Conakry, Guinea (O.S., B.B., A.C.); Korean Institute of Tuberculosis, Seoul, South Korea (H.K.); Komfo Anokye Teaching Hospital, Kumasi, Ghana (J.O.B., I.B.); University of New South Wales (G.B.M.) and University of Sydney (H.G.), Sydney; Centre for International Health, University of Otago, Dunedin, New Zealand (P.C.H.); and the Department of Medicine, King Saud University, King Abdulaziz Medical City, Riyadh, Saudi Arabia (H.A.-J.).'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Long', 'Affiliation': 'From the Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill University Health Centre Research Institute (D.M., A.T., C.V., K.H., M.-J.D., P.Z.L., K.S., A.B.), and the Department of Epidemiology and Biostatistics (D.M., A.B.), McGill University, Montreal, the Faculty of Medicine and Dentistry, University of Alberta, Edmonton (R.L.), the Faculty of Medicine, University of Saskatchewan, Saskatoon (V.H.), and the BC Centre for Disease Control and the University of British Columbia, Vancouver (K.E., V.J.C.) - all in Canada; Centre National Hospitalier Universitaire de Pneumo-Phtisiologie, Cotonou, Benin (M.A., M.G.); the Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia (R.R., L.A., R.C.K.); State University of Rio de Janeiro (A.T.), Programa Academico de Tuberculose-Faculdade de Medicina, Universidade Federal do Rio de Janeiro-Rede TB (A.K.), and National Institute of Infectious Diseases Evandro Chagas (V.R.) - all in Rio de Janeiro; Service de Pneumophtisiologie, Hôpital National Ignace Deen, Université Gamal Abdel Nasser de Conakry, Conakry, Guinea (O.S., B.B., A.C.); Korean Institute of Tuberculosis, Seoul, South Korea (H.K.); Komfo Anokye Teaching Hospital, Kumasi, Ghana (J.O.B., I.B.); University of New South Wales (G.B.M.) and University of Sydney (H.G.), Sydney; Centre for International Health, University of Otago, Dunedin, New Zealand (P.C.H.); and the Department of Medicine, King Saud University, King Abdulaziz Medical City, Riyadh, Saudi Arabia (H.A.-J.).'}, {'ForeName': 'Vernon', 'Initials': 'V', 'LastName': 'Hoeppner', 'Affiliation': 'From the Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill University Health Centre Research Institute (D.M., A.T., C.V., K.H., M.-J.D., P.Z.L., K.S., A.B.), and the Department of Epidemiology and Biostatistics (D.M., A.B.), McGill University, Montreal, the Faculty of Medicine and Dentistry, University of Alberta, Edmonton (R.L.), the Faculty of Medicine, University of Saskatchewan, Saskatoon (V.H.), and the BC Centre for Disease Control and the University of British Columbia, Vancouver (K.E., V.J.C.) - all in Canada; Centre National Hospitalier Universitaire de Pneumo-Phtisiologie, Cotonou, Benin (M.A., M.G.); the Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia (R.R., L.A., R.C.K.); State University of Rio de Janeiro (A.T.), Programa Academico de Tuberculose-Faculdade de Medicina, Universidade Federal do Rio de Janeiro-Rede TB (A.K.), and National Institute of Infectious Diseases Evandro Chagas (V.R.) - all in Rio de Janeiro; Service de Pneumophtisiologie, Hôpital National Ignace Deen, Université Gamal Abdel Nasser de Conakry, Conakry, Guinea (O.S., B.B., A.C.); Korean Institute of Tuberculosis, Seoul, South Korea (H.K.); Komfo Anokye Teaching Hospital, Kumasi, Ghana (J.O.B., I.B.); University of New South Wales (G.B.M.) and University of Sydney (H.G.), Sydney; Centre for International Health, University of Otago, Dunedin, New Zealand (P.C.H.); and the Department of Medicine, King Saud University, King Abdulaziz Medical City, Riyadh, Saudi Arabia (H.A.-J.).'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Elwood', 'Affiliation': 'From the Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill University Health Centre Research Institute (D.M., A.T., C.V., K.H., M.-J.D., P.Z.L., K.S., A.B.), and the Department of Epidemiology and Biostatistics (D.M., A.B.), McGill University, Montreal, the Faculty of Medicine and Dentistry, University of Alberta, Edmonton (R.L.), the Faculty of Medicine, University of Saskatchewan, Saskatoon (V.H.), and the BC Centre for Disease Control and the University of British Columbia, Vancouver (K.E., V.J.C.) - all in Canada; Centre National Hospitalier Universitaire de Pneumo-Phtisiologie, Cotonou, Benin (M.A., M.G.); the Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia (R.R., L.A., R.C.K.); State University of Rio de Janeiro (A.T.), Programa Academico de Tuberculose-Faculdade de Medicina, Universidade Federal do Rio de Janeiro-Rede TB (A.K.), and National Institute of Infectious Diseases Evandro Chagas (V.R.) - all in Rio de Janeiro; Service de Pneumophtisiologie, Hôpital National Ignace Deen, Université Gamal Abdel Nasser de Conakry, Conakry, Guinea (O.S., B.B., A.C.); Korean Institute of Tuberculosis, Seoul, South Korea (H.K.); Komfo Anokye Teaching Hospital, Kumasi, Ghana (J.O.B., I.B.); University of New South Wales (G.B.M.) and University of Sydney (H.G.), Sydney; Centre for International Health, University of Otago, Dunedin, New Zealand (P.C.H.); and the Department of Medicine, King Saud University, King Abdulaziz Medical City, Riyadh, Saudi Arabia (H.A.-J.).'}, {'ForeName': 'Hamdan', 'Initials': 'H', 'LastName': 'Al-Jahdali', 'Affiliation': 'From the Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill University Health Centre Research Institute (D.M., A.T., C.V., K.H., M.-J.D., P.Z.L., K.S., A.B.), and the Department of Epidemiology and Biostatistics (D.M., A.B.), McGill University, Montreal, the Faculty of Medicine and Dentistry, University of Alberta, Edmonton (R.L.), the Faculty of Medicine, University of Saskatchewan, Saskatoon (V.H.), and the BC Centre for Disease Control and the University of British Columbia, Vancouver (K.E., V.J.C.) - all in Canada; Centre National Hospitalier Universitaire de Pneumo-Phtisiologie, Cotonou, Benin (M.A., M.G.); the Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia (R.R., L.A., R.C.K.); State University of Rio de Janeiro (A.T.), Programa Academico de Tuberculose-Faculdade de Medicina, Universidade Federal do Rio de Janeiro-Rede TB (A.K.), and National Institute of Infectious Diseases Evandro Chagas (V.R.) - all in Rio de Janeiro; Service de Pneumophtisiologie, Hôpital National Ignace Deen, Université Gamal Abdel Nasser de Conakry, Conakry, Guinea (O.S., B.B., A.C.); Korean Institute of Tuberculosis, Seoul, South Korea (H.K.); Komfo Anokye Teaching Hospital, Kumasi, Ghana (J.O.B., I.B.); University of New South Wales (G.B.M.) and University of Sydney (H.G.), Sydney; Centre for International Health, University of Otago, Dunedin, New Zealand (P.C.H.); and the Department of Medicine, King Saud University, King Abdulaziz Medical City, Riyadh, Saudi Arabia (H.A.-J.).'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gninafon', 'Affiliation': 'From the Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill University Health Centre Research Institute (D.M., A.T., C.V., K.H., M.-J.D., P.Z.L., K.S., A.B.), and the Department of Epidemiology and Biostatistics (D.M., A.B.), McGill University, Montreal, the Faculty of Medicine and Dentistry, University of Alberta, Edmonton (R.L.), the Faculty of Medicine, University of Saskatchewan, Saskatoon (V.H.), and the BC Centre for Disease Control and the University of British Columbia, Vancouver (K.E., V.J.C.) - all in Canada; Centre National Hospitalier Universitaire de Pneumo-Phtisiologie, Cotonou, Benin (M.A., M.G.); the Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia (R.R., L.A., R.C.K.); State University of Rio de Janeiro (A.T.), Programa Academico de Tuberculose-Faculdade de Medicina, Universidade Federal do Rio de Janeiro-Rede TB (A.K.), and National Institute of Infectious Diseases Evandro Chagas (V.R.) - all in Rio de Janeiro; Service de Pneumophtisiologie, Hôpital National Ignace Deen, Université Gamal Abdel Nasser de Conakry, Conakry, Guinea (O.S., B.B., A.C.); Korean Institute of Tuberculosis, Seoul, South Korea (H.K.); Komfo Anokye Teaching Hospital, Kumasi, Ghana (J.O.B., I.B.); University of New South Wales (G.B.M.) and University of Sydney (H.G.), Sydney; Centre for International Health, University of Otago, Dunedin, New Zealand (P.C.H.); and the Department of Medicine, King Saud University, King Abdulaziz Medical City, Riyadh, Saudi Arabia (H.A.-J.).'}, {'ForeName': 'Lika', 'Initials': 'L', 'LastName': 'Apriani', 'Affiliation': 'From the Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill University Health Centre Research Institute (D.M., A.T., C.V., K.H., M.-J.D., P.Z.L., K.S., A.B.), and the Department of Epidemiology and Biostatistics (D.M., A.B.), McGill University, Montreal, the Faculty of Medicine and Dentistry, University of Alberta, Edmonton (R.L.), the Faculty of Medicine, University of Saskatchewan, Saskatoon (V.H.), and the BC Centre for Disease Control and the University of British Columbia, Vancouver (K.E., V.J.C.) - all in Canada; Centre National Hospitalier Universitaire de Pneumo-Phtisiologie, Cotonou, Benin (M.A., M.G.); the Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia (R.R., L.A., R.C.K.); State University of Rio de Janeiro (A.T.), Programa Academico de Tuberculose-Faculdade de Medicina, Universidade Federal do Rio de Janeiro-Rede TB (A.K.), and National Institute of Infectious Diseases Evandro Chagas (V.R.) - all in Rio de Janeiro; Service de Pneumophtisiologie, Hôpital National Ignace Deen, Université Gamal Abdel Nasser de Conakry, Conakry, Guinea (O.S., B.B., A.C.); Korean Institute of Tuberculosis, Seoul, South Korea (H.K.); Komfo Anokye Teaching Hospital, Kumasi, Ghana (J.O.B., I.B.); University of New South Wales (G.B.M.) and University of Sydney (H.G.), Sydney; Centre for International Health, University of Otago, Dunedin, New Zealand (P.C.H.); and the Department of Medicine, King Saud University, King Abdulaziz Medical City, Riyadh, Saudi Arabia (H.A.-J.).'}, {'ForeName': 'Raspati C', 'Initials': 'RC', 'LastName': 'Koesoemadinata', 'Affiliation': 'From the Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill University Health Centre Research Institute (D.M., A.T., C.V., K.H., M.-J.D., P.Z.L., K.S., A.B.), and the Department of Epidemiology and Biostatistics (D.M., A.B.), McGill University, Montreal, the Faculty of Medicine and Dentistry, University of Alberta, Edmonton (R.L.), the Faculty of Medicine, University of Saskatchewan, Saskatoon (V.H.), and the BC Centre for Disease Control and the University of British Columbia, Vancouver (K.E., V.J.C.) - all in Canada; Centre National Hospitalier Universitaire de Pneumo-Phtisiologie, Cotonou, Benin (M.A., M.G.); the Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia (R.R., L.A., R.C.K.); State University of Rio de Janeiro (A.T.), Programa Academico de Tuberculose-Faculdade de Medicina, Universidade Federal do Rio de Janeiro-Rede TB (A.K.), and National Institute of Infectious Diseases Evandro Chagas (V.R.) - all in Rio de Janeiro; Service de Pneumophtisiologie, Hôpital National Ignace Deen, Université Gamal Abdel Nasser de Conakry, Conakry, Guinea (O.S., B.B., A.C.); Korean Institute of Tuberculosis, Seoul, South Korea (H.K.); Komfo Anokye Teaching Hospital, Kumasi, Ghana (J.O.B., I.B.); University of New South Wales (G.B.M.) and University of Sydney (H.G.), Sydney; Centre for International Health, University of Otago, Dunedin, New Zealand (P.C.H.); and the Department of Medicine, King Saud University, King Abdulaziz Medical City, Riyadh, Saudi Arabia (H.A.-J.).'}, {'ForeName': 'Afranio', 'Initials': 'A', 'LastName': 'Kritski', 'Affiliation': 'From the Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill University Health Centre Research Institute (D.M., A.T., C.V., K.H., M.-J.D., P.Z.L., K.S., A.B.), and the Department of Epidemiology and Biostatistics (D.M., A.B.), McGill University, Montreal, the Faculty of Medicine and Dentistry, University of Alberta, Edmonton (R.L.), the Faculty of Medicine, University of Saskatchewan, Saskatoon (V.H.), and the BC Centre for Disease Control and the University of British Columbia, Vancouver (K.E., V.J.C.) - all in Canada; Centre National Hospitalier Universitaire de Pneumo-Phtisiologie, Cotonou, Benin (M.A., M.G.); the Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia (R.R., L.A., R.C.K.); State University of Rio de Janeiro (A.T.), Programa Academico de Tuberculose-Faculdade de Medicina, Universidade Federal do Rio de Janeiro-Rede TB (A.K.), and National Institute of Infectious Diseases Evandro Chagas (V.R.) - all in Rio de Janeiro; Service de Pneumophtisiologie, Hôpital National Ignace Deen, Université Gamal Abdel Nasser de Conakry, Conakry, Guinea (O.S., B.B., A.C.); Korean Institute of Tuberculosis, Seoul, South Korea (H.K.); Komfo Anokye Teaching Hospital, Kumasi, Ghana (J.O.B., I.B.); University of New South Wales (G.B.M.) and University of Sydney (H.G.), Sydney; Centre for International Health, University of Otago, Dunedin, New Zealand (P.C.H.); and the Department of Medicine, King Saud University, King Abdulaziz Medical City, Riyadh, Saudi Arabia (H.A.-J.).'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Rolla', 'Affiliation': 'From the Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill University Health Centre Research Institute (D.M., A.T., C.V., K.H., M.-J.D., P.Z.L., K.S., A.B.), and the Department of Epidemiology and Biostatistics (D.M., A.B.), McGill University, Montreal, the Faculty of Medicine and Dentistry, University of Alberta, Edmonton (R.L.), the Faculty of Medicine, University of Saskatchewan, Saskatoon (V.H.), and the BC Centre for Disease Control and the University of British Columbia, Vancouver (K.E., V.J.C.) - all in Canada; Centre National Hospitalier Universitaire de Pneumo-Phtisiologie, Cotonou, Benin (M.A., M.G.); the Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia (R.R., L.A., R.C.K.); State University of Rio de Janeiro (A.T.), Programa Academico de Tuberculose-Faculdade de Medicina, Universidade Federal do Rio de Janeiro-Rede TB (A.K.), and National Institute of Infectious Diseases Evandro Chagas (V.R.) - all in Rio de Janeiro; Service de Pneumophtisiologie, Hôpital National Ignace Deen, Université Gamal Abdel Nasser de Conakry, Conakry, Guinea (O.S., B.B., A.C.); Korean Institute of Tuberculosis, Seoul, South Korea (H.K.); Komfo Anokye Teaching Hospital, Kumasi, Ghana (J.O.B., I.B.); University of New South Wales (G.B.M.) and University of Sydney (H.G.), Sydney; Centre for International Health, University of Otago, Dunedin, New Zealand (P.C.H.); and the Department of Medicine, King Saud University, King Abdulaziz Medical City, Riyadh, Saudi Arabia (H.A.-J.).'}, {'ForeName': 'Boubacar', 'Initials': 'B', 'LastName': 'Bah', 'Affiliation': 'From the Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill University Health Centre Research Institute (D.M., A.T., C.V., K.H., M.-J.D., P.Z.L., K.S., A.B.), and the Department of Epidemiology and Biostatistics (D.M., A.B.), McGill University, Montreal, the Faculty of Medicine and Dentistry, University of Alberta, Edmonton (R.L.), the Faculty of Medicine, University of Saskatchewan, Saskatoon (V.H.), and the BC Centre for Disease Control and the University of British Columbia, Vancouver (K.E., V.J.C.) - all in Canada; Centre National Hospitalier Universitaire de Pneumo-Phtisiologie, Cotonou, Benin (M.A., M.G.); the Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia (R.R., L.A., R.C.K.); State University of Rio de Janeiro (A.T.), Programa Academico de Tuberculose-Faculdade de Medicina, Universidade Federal do Rio de Janeiro-Rede TB (A.K.), and National Institute of Infectious Diseases Evandro Chagas (V.R.) - all in Rio de Janeiro; Service de Pneumophtisiologie, Hôpital National Ignace Deen, Université Gamal Abdel Nasser de Conakry, Conakry, Guinea (O.S., B.B., A.C.); Korean Institute of Tuberculosis, Seoul, South Korea (H.K.); Komfo Anokye Teaching Hospital, Kumasi, Ghana (J.O.B., I.B.); University of New South Wales (G.B.M.) and University of Sydney (H.G.), Sydney; Centre for International Health, University of Otago, Dunedin, New Zealand (P.C.H.); and the Department of Medicine, King Saud University, King Abdulaziz Medical City, Riyadh, Saudi Arabia (H.A.-J.).'}, {'ForeName': 'Alioune', 'Initials': 'A', 'LastName': 'Camara', 'Affiliation': 'From the Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill University Health Centre Research Institute (D.M., A.T., C.V., K.H., M.-J.D., P.Z.L., K.S., A.B.), and the Department of Epidemiology and Biostatistics (D.M., A.B.), McGill University, Montreal, the Faculty of Medicine and Dentistry, University of Alberta, Edmonton (R.L.), the Faculty of Medicine, University of Saskatchewan, Saskatoon (V.H.), and the BC Centre for Disease Control and the University of British Columbia, Vancouver (K.E., V.J.C.) - all in Canada; Centre National Hospitalier Universitaire de Pneumo-Phtisiologie, Cotonou, Benin (M.A., M.G.); the Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia (R.R., L.A., R.C.K.); State University of Rio de Janeiro (A.T.), Programa Academico de Tuberculose-Faculdade de Medicina, Universidade Federal do Rio de Janeiro-Rede TB (A.K.), and National Institute of Infectious Diseases Evandro Chagas (V.R.) - all in Rio de Janeiro; Service de Pneumophtisiologie, Hôpital National Ignace Deen, Université Gamal Abdel Nasser de Conakry, Conakry, Guinea (O.S., B.B., A.C.); Korean Institute of Tuberculosis, Seoul, South Korea (H.K.); Komfo Anokye Teaching Hospital, Kumasi, Ghana (J.O.B., I.B.); University of New South Wales (G.B.M.) and University of Sydney (H.G.), Sydney; Centre for International Health, University of Otago, Dunedin, New Zealand (P.C.H.); and the Department of Medicine, King Saud University, King Abdulaziz Medical City, Riyadh, Saudi Arabia (H.A.-J.).'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Boakye', 'Affiliation': 'From the Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill University Health Centre Research Institute (D.M., A.T., C.V., K.H., M.-J.D., P.Z.L., K.S., A.B.), and the Department of Epidemiology and Biostatistics (D.M., A.B.), McGill University, Montreal, the Faculty of Medicine and Dentistry, University of Alberta, Edmonton (R.L.), the Faculty of Medicine, University of Saskatchewan, Saskatoon (V.H.), and the BC Centre for Disease Control and the University of British Columbia, Vancouver (K.E., V.J.C.) - all in Canada; Centre National Hospitalier Universitaire de Pneumo-Phtisiologie, Cotonou, Benin (M.A., M.G.); the Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia (R.R., L.A., R.C.K.); State University of Rio de Janeiro (A.T.), Programa Academico de Tuberculose-Faculdade de Medicina, Universidade Federal do Rio de Janeiro-Rede TB (A.K.), and National Institute of Infectious Diseases Evandro Chagas (V.R.) - all in Rio de Janeiro; Service de Pneumophtisiologie, Hôpital National Ignace Deen, Université Gamal Abdel Nasser de Conakry, Conakry, Guinea (O.S., B.B., A.C.); Korean Institute of Tuberculosis, Seoul, South Korea (H.K.); Komfo Anokye Teaching Hospital, Kumasi, Ghana (J.O.B., I.B.); University of New South Wales (G.B.M.) and University of Sydney (H.G.), Sydney; Centre for International Health, University of Otago, Dunedin, New Zealand (P.C.H.); and the Department of Medicine, King Saud University, King Abdulaziz Medical City, Riyadh, Saudi Arabia (H.A.-J.).'}, {'ForeName': 'Victoria J', 'Initials': 'VJ', 'LastName': 'Cook', 'Affiliation': 'From the Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill University Health Centre Research Institute (D.M., A.T., C.V., K.H., M.-J.D., P.Z.L., K.S., A.B.), and the Department of Epidemiology and Biostatistics (D.M., A.B.), McGill University, Montreal, the Faculty of Medicine and Dentistry, University of Alberta, Edmonton (R.L.), the Faculty of Medicine, University of Saskatchewan, Saskatoon (V.H.), and the BC Centre for Disease Control and the University of British Columbia, Vancouver (K.E., V.J.C.) - all in Canada; Centre National Hospitalier Universitaire de Pneumo-Phtisiologie, Cotonou, Benin (M.A., M.G.); the Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia (R.R., L.A., R.C.K.); State University of Rio de Janeiro (A.T.), Programa Academico de Tuberculose-Faculdade de Medicina, Universidade Federal do Rio de Janeiro-Rede TB (A.K.), and National Institute of Infectious Diseases Evandro Chagas (V.R.) - all in Rio de Janeiro; Service de Pneumophtisiologie, Hôpital National Ignace Deen, Université Gamal Abdel Nasser de Conakry, Conakry, Guinea (O.S., B.B., A.C.); Korean Institute of Tuberculosis, Seoul, South Korea (H.K.); Komfo Anokye Teaching Hospital, Kumasi, Ghana (J.O.B., I.B.); University of New South Wales (G.B.M.) and University of Sydney (H.G.), Sydney; Centre for International Health, University of Otago, Dunedin, New Zealand (P.C.H.); and the Department of Medicine, King Saud University, King Abdulaziz Medical City, Riyadh, Saudi Arabia (H.A.-J.).'}, {'ForeName': 'Hazel', 'Initials': 'H', 'LastName': 'Goldberg', 'Affiliation': 'From the Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill University Health Centre Research Institute (D.M., A.T., C.V., K.H., M.-J.D., P.Z.L., K.S., A.B.), and the Department of Epidemiology and Biostatistics (D.M., A.B.), McGill University, Montreal, the Faculty of Medicine and Dentistry, University of Alberta, Edmonton (R.L.), the Faculty of Medicine, University of Saskatchewan, Saskatoon (V.H.), and the BC Centre for Disease Control and the University of British Columbia, Vancouver (K.E., V.J.C.) - all in Canada; Centre National Hospitalier Universitaire de Pneumo-Phtisiologie, Cotonou, Benin (M.A., M.G.); the Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia (R.R., L.A., R.C.K.); State University of Rio de Janeiro (A.T.), Programa Academico de Tuberculose-Faculdade de Medicina, Universidade Federal do Rio de Janeiro-Rede TB (A.K.), and National Institute of Infectious Diseases Evandro Chagas (V.R.) - all in Rio de Janeiro; Service de Pneumophtisiologie, Hôpital National Ignace Deen, Université Gamal Abdel Nasser de Conakry, Conakry, Guinea (O.S., B.B., A.C.); Korean Institute of Tuberculosis, Seoul, South Korea (H.K.); Komfo Anokye Teaching Hospital, Kumasi, Ghana (J.O.B., I.B.); University of New South Wales (G.B.M.) and University of Sydney (H.G.), Sydney; Centre for International Health, University of Otago, Dunedin, New Zealand (P.C.H.); and the Department of Medicine, King Saud University, King Abdulaziz Medical City, Riyadh, Saudi Arabia (H.A.-J.).'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Valiquette', 'Affiliation': 'From the Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill University Health Centre Research Institute (D.M., A.T., C.V., K.H., M.-J.D., P.Z.L., K.S., A.B.), and the Department of Epidemiology and Biostatistics (D.M., A.B.), McGill University, Montreal, the Faculty of Medicine and Dentistry, University of Alberta, Edmonton (R.L.), the Faculty of Medicine, University of Saskatchewan, Saskatoon (V.H.), and the BC Centre for Disease Control and the University of British Columbia, Vancouver (K.E., V.J.C.) - all in Canada; Centre National Hospitalier Universitaire de Pneumo-Phtisiologie, Cotonou, Benin (M.A., M.G.); the Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia (R.R., L.A., R.C.K.); State University of Rio de Janeiro (A.T.), Programa Academico de Tuberculose-Faculdade de Medicina, Universidade Federal do Rio de Janeiro-Rede TB (A.K.), and National Institute of Infectious Diseases Evandro Chagas (V.R.) - all in Rio de Janeiro; Service de Pneumophtisiologie, Hôpital National Ignace Deen, Université Gamal Abdel Nasser de Conakry, Conakry, Guinea (O.S., B.B., A.C.); Korean Institute of Tuberculosis, Seoul, South Korea (H.K.); Komfo Anokye Teaching Hospital, Kumasi, Ghana (J.O.B., I.B.); University of New South Wales (G.B.M.) and University of Sydney (H.G.), Sydney; Centre for International Health, University of Otago, Dunedin, New Zealand (P.C.H.); and the Department of Medicine, King Saud University, King Abdulaziz Medical City, Riyadh, Saudi Arabia (H.A.-J.).'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hornby', 'Affiliation': 'From the Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill University Health Centre Research Institute (D.M., A.T., C.V., K.H., M.-J.D., P.Z.L., K.S., A.B.), and the Department of Epidemiology and Biostatistics (D.M., A.B.), McGill University, Montreal, the Faculty of Medicine and Dentistry, University of Alberta, Edmonton (R.L.), the Faculty of Medicine, University of Saskatchewan, Saskatoon (V.H.), and the BC Centre for Disease Control and the University of British Columbia, Vancouver (K.E., V.J.C.) - all in Canada; Centre National Hospitalier Universitaire de Pneumo-Phtisiologie, Cotonou, Benin (M.A., M.G.); the Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia (R.R., L.A., R.C.K.); State University of Rio de Janeiro (A.T.), Programa Academico de Tuberculose-Faculdade de Medicina, Universidade Federal do Rio de Janeiro-Rede TB (A.K.), and National Institute of Infectious Diseases Evandro Chagas (V.R.) - all in Rio de Janeiro; Service de Pneumophtisiologie, Hôpital National Ignace Deen, Université Gamal Abdel Nasser de Conakry, Conakry, Guinea (O.S., B.B., A.C.); Korean Institute of Tuberculosis, Seoul, South Korea (H.K.); Komfo Anokye Teaching Hospital, Kumasi, Ghana (J.O.B., I.B.); University of New South Wales (G.B.M.) and University of Sydney (H.G.), Sydney; Centre for International Health, University of Otago, Dunedin, New Zealand (P.C.H.); and the Department of Medicine, King Saud University, King Abdulaziz Medical City, Riyadh, Saudi Arabia (H.A.-J.).'}, {'ForeName': 'Marie-Josée', 'Initials': 'MJ', 'LastName': 'Dion', 'Affiliation': 'From the Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill University Health Centre Research Institute (D.M., A.T., C.V., K.H., M.-J.D., P.Z.L., K.S., A.B.), and the Department of Epidemiology and Biostatistics (D.M., A.B.), McGill University, Montreal, the Faculty of Medicine and Dentistry, University of Alberta, Edmonton (R.L.), the Faculty of Medicine, University of Saskatchewan, Saskatoon (V.H.), and the BC Centre for Disease Control and the University of British Columbia, Vancouver (K.E., V.J.C.) - all in Canada; Centre National Hospitalier Universitaire de Pneumo-Phtisiologie, Cotonou, Benin (M.A., M.G.); the Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia (R.R., L.A., R.C.K.); State University of Rio de Janeiro (A.T.), Programa Academico de Tuberculose-Faculdade de Medicina, Universidade Federal do Rio de Janeiro-Rede TB (A.K.), and National Institute of Infectious Diseases Evandro Chagas (V.R.) - all in Rio de Janeiro; Service de Pneumophtisiologie, Hôpital National Ignace Deen, Université Gamal Abdel Nasser de Conakry, Conakry, Guinea (O.S., B.B., A.C.); Korean Institute of Tuberculosis, Seoul, South Korea (H.K.); Komfo Anokye Teaching Hospital, Kumasi, Ghana (J.O.B., I.B.); University of New South Wales (G.B.M.) and University of Sydney (H.G.), Sydney; Centre for International Health, University of Otago, Dunedin, New Zealand (P.C.H.); and the Department of Medicine, King Saud University, King Abdulaziz Medical City, Riyadh, Saudi Arabia (H.A.-J.).'}, {'ForeName': 'Pei-Zhi', 'Initials': 'PZ', 'LastName': 'Li', 'Affiliation': 'From the Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill University Health Centre Research Institute (D.M., A.T., C.V., K.H., M.-J.D., P.Z.L., K.S., A.B.), and the Department of Epidemiology and Biostatistics (D.M., A.B.), McGill University, Montreal, the Faculty of Medicine and Dentistry, University of Alberta, Edmonton (R.L.), the Faculty of Medicine, University of Saskatchewan, Saskatoon (V.H.), and the BC Centre for Disease Control and the University of British Columbia, Vancouver (K.E., V.J.C.) - all in Canada; Centre National Hospitalier Universitaire de Pneumo-Phtisiologie, Cotonou, Benin (M.A., M.G.); the Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia (R.R., L.A., R.C.K.); State University of Rio de Janeiro (A.T.), Programa Academico de Tuberculose-Faculdade de Medicina, Universidade Federal do Rio de Janeiro-Rede TB (A.K.), and National Institute of Infectious Diseases Evandro Chagas (V.R.) - all in Rio de Janeiro; Service de Pneumophtisiologie, Hôpital National Ignace Deen, Université Gamal Abdel Nasser de Conakry, Conakry, Guinea (O.S., B.B., A.C.); Korean Institute of Tuberculosis, Seoul, South Korea (H.K.); Komfo Anokye Teaching Hospital, Kumasi, Ghana (J.O.B., I.B.); University of New South Wales (G.B.M.) and University of Sydney (H.G.), Sydney; Centre for International Health, University of Otago, Dunedin, New Zealand (P.C.H.); and the Department of Medicine, King Saud University, King Abdulaziz Medical City, Riyadh, Saudi Arabia (H.A.-J.).'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Hill', 'Affiliation': 'From the Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill University Health Centre Research Institute (D.M., A.T., C.V., K.H., M.-J.D., P.Z.L., K.S., A.B.), and the Department of Epidemiology and Biostatistics (D.M., A.B.), McGill University, Montreal, the Faculty of Medicine and Dentistry, University of Alberta, Edmonton (R.L.), the Faculty of Medicine, University of Saskatchewan, Saskatoon (V.H.), and the BC Centre for Disease Control and the University of British Columbia, Vancouver (K.E., V.J.C.) - all in Canada; Centre National Hospitalier Universitaire de Pneumo-Phtisiologie, Cotonou, Benin (M.A., M.G.); the Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia (R.R., L.A., R.C.K.); State University of Rio de Janeiro (A.T.), Programa Academico de Tuberculose-Faculdade de Medicina, Universidade Federal do Rio de Janeiro-Rede TB (A.K.), and National Institute of Infectious Diseases Evandro Chagas (V.R.) - all in Rio de Janeiro; Service de Pneumophtisiologie, Hôpital National Ignace Deen, Université Gamal Abdel Nasser de Conakry, Conakry, Guinea (O.S., B.B., A.C.); Korean Institute of Tuberculosis, Seoul, South Korea (H.K.); Komfo Anokye Teaching Hospital, Kumasi, Ghana (J.O.B., I.B.); University of New South Wales (G.B.M.) and University of Sydney (H.G.), Sydney; Centre for International Health, University of Otago, Dunedin, New Zealand (P.C.H.); and the Department of Medicine, King Saud University, King Abdulaziz Medical City, Riyadh, Saudi Arabia (H.A.-J.).'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Schwartzman', 'Affiliation': 'From the Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill University Health Centre Research Institute (D.M., A.T., C.V., K.H., M.-J.D., P.Z.L., K.S., A.B.), and the Department of Epidemiology and Biostatistics (D.M., A.B.), McGill University, Montreal, the Faculty of Medicine and Dentistry, University of Alberta, Edmonton (R.L.), the Faculty of Medicine, University of Saskatchewan, Saskatoon (V.H.), and the BC Centre for Disease Control and the University of British Columbia, Vancouver (K.E., V.J.C.) - all in Canada; Centre National Hospitalier Universitaire de Pneumo-Phtisiologie, Cotonou, Benin (M.A., M.G.); the Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia (R.R., L.A., R.C.K.); State University of Rio de Janeiro (A.T.), Programa Academico de Tuberculose-Faculdade de Medicina, Universidade Federal do Rio de Janeiro-Rede TB (A.K.), and National Institute of Infectious Diseases Evandro Chagas (V.R.) - all in Rio de Janeiro; Service de Pneumophtisiologie, Hôpital National Ignace Deen, Université Gamal Abdel Nasser de Conakry, Conakry, Guinea (O.S., B.B., A.C.); Korean Institute of Tuberculosis, Seoul, South Korea (H.K.); Komfo Anokye Teaching Hospital, Kumasi, Ghana (J.O.B., I.B.); University of New South Wales (G.B.M.) and University of Sydney (H.G.), Sydney; Centre for International Health, University of Otago, Dunedin, New Zealand (P.C.H.); and the Department of Medicine, King Saud University, King Abdulaziz Medical City, Riyadh, Saudi Arabia (H.A.-J.).'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Benedetti', 'Affiliation': 'From the Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill University Health Centre Research Institute (D.M., A.T., C.V., K.H., M.-J.D., P.Z.L., K.S., A.B.), and the Department of Epidemiology and Biostatistics (D.M., A.B.), McGill University, Montreal, the Faculty of Medicine and Dentistry, University of Alberta, Edmonton (R.L.), the Faculty of Medicine, University of Saskatchewan, Saskatoon (V.H.), and the BC Centre for Disease Control and the University of British Columbia, Vancouver (K.E., V.J.C.) - all in Canada; Centre National Hospitalier Universitaire de Pneumo-Phtisiologie, Cotonou, Benin (M.A., M.G.); the Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia (R.R., L.A., R.C.K.); State University of Rio de Janeiro (A.T.), Programa Academico de Tuberculose-Faculdade de Medicina, Universidade Federal do Rio de Janeiro-Rede TB (A.K.), and National Institute of Infectious Diseases Evandro Chagas (V.R.) - all in Rio de Janeiro; Service de Pneumophtisiologie, Hôpital National Ignace Deen, Université Gamal Abdel Nasser de Conakry, Conakry, Guinea (O.S., B.B., A.C.); Korean Institute of Tuberculosis, Seoul, South Korea (H.K.); Komfo Anokye Teaching Hospital, Kumasi, Ghana (J.O.B., I.B.); University of New South Wales (G.B.M.) and University of Sydney (H.G.), Sydney; Centre for International Health, University of Otago, Dunedin, New Zealand (P.C.H.); and the Department of Medicine, King Saud University, King Abdulaziz Medical City, Riyadh, Saudi Arabia (H.A.-J.).'}]",The New England journal of medicine,['10.1056/NEJMoa1714283']
1528,29963411,Antibiotic stewardship program in Intensive Care Unit: First report from Iran.,"Introduction


Few data regarding antibiotic stewardship programs in critically ill patients are available. In the present study, the consequence of changing an empirical antibiotic regimen from a carbapenem (meropenem) to a noncarbapenem antibiotic (piperacillin-tazobactam) was evaluated in critically ill patients with a suspicion of sepsis.
Methods


This open-label randomized clinical trial was conducted during May 2015-January 2017 at the general Intensive Care Unit of the Imam Khomeini Hospital Complex, Tehran, Iran. In this study, a carbapenem (meropenem) or a noncarbapenem (piperacillin-tazobactam) antibiotic was considered as an empirical antibiotic regimen in 100 critically ill patients with a suspicion of sepsis. Clinical response and bacterial eradication were defined as primary and secondary outcomes of the study, respectively. Chi-square, Mann-Whitney, and independent sample  t -tests were used for comparing variables between the groups. ANOVA was used to compare changes in the mean differences of parameters between the groups. Meaningful difference was indicated as  P  ≤ 0.05.
Results


During the first 72 h of the antibiotic course, the number of patients with clinical response was comparable between piperacillin-tazobactam and meropenem groups (21 [42%] and 25 [50%], respectively,  P  = 0.31). Also, at this time, microbial eradication occurred in 13 (54.16%) and 9 (40.90%) patients in piperacillin-tazobactam and meropenem groups, respectively ( P  = 0.67).
Conclusions


Using a carbapenem (meropenem) instead of a noncarbapenem (piperacillin-tazobactam) as an empirical antibiotic regimen did not affect clinical response and bacterial eradication rates in critically ill patients with a suspicion of sepsis.",2018,"During the first 72 h of the antibiotic course, the number of patients with clinical response was comparable between piperacillin-tazobactam and meropenem groups (21 [42%] and 25 [50%], respectively,  P  = 0.31).","['critically ill patients with a suspicion of sepsis', '100 critically ill patients with a suspicion of sepsis', 'critically ill patients', 'May 2015-January 2017 at the general Intensive Care Unit of the Imam Khomeini Hospital Complex, Tehran, Iran', 'Intensive Care Unit']","['noncarbapenem (piperacillin-tazobactam) antibiotic', 'noncarbapenem antibiotic (piperacillin-tazobactam', 'piperacillin-tazobactam', 'noncarbapenem (piperacillin-tazobactam', 'carbapenem (meropenem', 'Antibiotic stewardship program']","['Clinical response and bacterial eradication', 'microbial eradication', 'clinical response and bacterial eradication rates', 'number of patients with clinical response']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242114', 'cui_str': 'Suspicion'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C0250480', 'cui_str': 'Piperacillin / tazobactam'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0006968', 'cui_str': 'Antibiotics, Carbapenem'}, {'cui': 'C0066005', 'cui_str': 'meropenem'}, {'cui': 'C4505100', 'cui_str': 'Antibiotic Stewardship'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",100.0,0.0618802,"During the first 72 h of the antibiotic course, the number of patients with clinical response was comparable between piperacillin-tazobactam and meropenem groups (21 [42%] and 25 [50%], respectively,  P  = 0.31).","[{'ForeName': 'Ghoncheh', 'Initials': 'G', 'LastName': 'Vahidi', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Intensive Care Unit, Faculty of Medicine, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Lida', 'Initials': 'L', 'LastName': 'Shojaei', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Kermanshah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Ramezani', 'Affiliation': 'Department of Intensive Care Unit, Faculty of Medicine, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sirus', 'Initials': 'S', 'LastName': 'Jafari', 'Affiliation': 'Department of Infectious Diseases, Faculty of Medicine, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Khalili', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}]",International journal of critical illness and injury science,['10.4103/IJCIIS.IJCIIS_10_18']
1529,29507743,"Effect of transporting an evidence-based, violence prevention intervention to Jamaican preschools on teacher and class-wide child behaviour: a cluster randomised trial.","Introduction


Based on extensive piloting work, we adapted the Incredible Years (IY) teacher-training programme to the Jamaican preschool setting and evaluated this adapted version through a cluster-randomised trial.
Methods


Twenty-four community preschools in Kingston, Jamaica were randomly assigned to intervention (12 schools, 37 teachers) or control (12 schools, 36 teachers). The intervention involved training teachers in classroom management through eight full-day training workshops and four individual 1-h in-class support sessions. Outcome measurements included direct observation of teachers' positive and negative behaviours to the whole class and to high-risk children and four observer ratings: two measures of class-wide child behaviour and two measures of classroom atmosphere. Measures were repeated at a six-month follow-up.
Results


Significant benefits of intervention were found for teachers' positive [effect size (ES) = 3.35] and negative (ES = 1.29) behaviours to the whole class and to high-risk children (positive: ES = 0.83; negative: ES = 0.50) and for observer ratings of class-wide child behaviour (ES = 0.73), child interest and enthusiasm (ES = 0.98), teacher warmth (ES = 2.03) and opportunities provided to share and help (ES = 5.72). At 6-month follow-up, significant benefits of intervention were sustained: positive behaviours (ES = 2.70), negative behaviours (ES = 0.98), child behaviour (ES = 0.50), child interest and enthusiasm (ES = 0.78), teacher warmth (ES = 0.91), opportunities to share and help (ES = 1.42).
Conclusions


The adapted IY teacher-training programme produced large benefits to teacher's behaviour and to class-wide measures of children's behaviour, which were sustained at 6-month follow-up. Benefits were of a similar magnitude to those found in a pilot study of the minimally adapted version that required significantly more in-class support for teachers.",2018,"The adapted IY teacher-training programme produced large benefits to teacher's behaviour and to class-wide measures of children's behaviour, which were sustained at 6-month follow-up.","['Jamaican preschools on teacher and class-wide child behaviour', 'Methods\n\n\nTwenty-four community preschools in Kingston, Jamaica were randomly assigned to intervention (12 schools, 37 teachers) or control (12 schools, 36 teachers']","['violence prevention intervention', 'intervention involved training teachers in classroom management through eight full-day training workshops and four individual 1-h in-class support sessions']","[""direct observation of teachers' positive and negative behaviours to the whole class and to high-risk children and four observer ratings: two measures of class-wide child behaviour and two measures of classroom atmosphere"", 'negative behaviours (ES = 0.98), child behaviour (ES = 0.50), child interest and enthusiasm (ES = 0.78), teacher warmth']","[{'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0022337', 'cui_str': 'Jamaica'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0150215', 'cui_str': 'Violence prevention'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0004178', 'cui_str': 'Atmosphere'}, {'cui': 'C0424090', 'cui_str': 'Level of interest (observable entity)'}, {'cui': 'C4517480', 'cui_str': 'Zero point seven eight'}]",37.0,0.0243866,"The adapted IY teacher-training programme produced large benefits to teacher's behaviour and to class-wide measures of children's behaviour, which were sustained at 6-month follow-up.","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Baker-Henningham', 'Affiliation': 'School of Psychology, Bangor University, Bangor, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Walker', 'Affiliation': 'Caribbean Institute for Health Research, University of the West Indies, Kingston §7, Jamaica.'}]","Global mental health (Cambridge, England)",['10.1017/gmh.2017.29']
1530,29878061,Nutrient enrichment of human milk with human and bovine milk-based fortifiers for infants born weighing <1250 g: a randomized clinical trial.,"Background


Human milk-based fortifiers (HMBFs) are being adopted in neonatal care to enrich the nutrients in human milk for very low birth weight (VLBW) infants despite being costly and there being limited efficacy data. No randomized clinical trial has evaluated the use of HMBF compared with bovine milk-based fortifiers (BMBFs) in the absence of formula feeding.
Objective


To determine if HMBF compared with BMBF for routine nutrient enrichment of human milk improves feeding tolerance, reduces morbidity, reduces fecal calprotectin (a measure of gut inflammation), and supports the growth of infants <1250 g.
Design


In this blinded randomized clinical trial, infants born weighing <1250 g were recruited from neonatal units in Ontario, Canada between August 2014 and November 2015. The infants were fed mother's milk and donor milk as required. Fortification commenced at 100 mL/kg per day of HMBF (0.81 kcal/mL) or BMBF (0.72 kcal/mL) and advanced at 140 mL/kg per day to 0.88 and 0.78 kcal/mL, respectively. The primary outcome was percentage of infants with a feeding interruption for ≥12 h or a >50% reduction in feeding volume. Secondary outcomes included a dichotomous mortality and morbidity index (i.e., affirmative for any one of death, late-onset sepsis, necrotizing enterocolitis, chronic lung disease, or severe retinopathy of prematurity), fecal calprotectin, and growth.
Results


Of 232 eligible infants, 127 (54.7%) were randomized (n = 64 HMBF, n = 63 BMBF). Mean ± SD birth weight and gestational age of infants were 888 ± 201 g and 27.7 ± 2.5 wk, respectively. No statistically significant differences were identified in feeding interruptions [17/64 HMBF, 20/61 BMBF; unadjusted risk difference: -6.2% (95% CI: -22.2%, 9.8%)]. There was no statistically significant difference in the mortality and morbidity index (48.4% HMBF, 49.2% BMBF, adjusted P = 0.76), changes in fecal calprotectin, or growth z scores.
Conclusions


Among infants born weighing <1250 g and exclusively fed human milk, the use of HMBF did not improve feeding tolerance or reduce mortality and morbidity compared with BMBF. This trial was registered at clinicaltrials.gov as NCT02137473.",2018,"There was no statistically significant difference in the mortality and morbidity index (48.4% HMBF, 49.2% BMBF, adjusted P = 0.76), changes in fecal calprotectin, or growth z scores.
","['infants born weighing <1250 g and exclusively fed human milk', '232 eligible infants, 127 (54.7', 'infants born weighing <1250 g', 'infants born weighing <1250 g were recruited from neonatal units in Ontario, Canada between August 2014 and November 2015']","['bovine milk-based fortifiers (BMBFs', 'Nutrient enrichment of human milk with human and bovine milk-based fortifiers', 'BMBF', '\n\n\nHuman milk-based fortifiers (HMBFs', 'HMBF']","['percentage of infants with a feeding interruption for ≥12 h or a >50% reduction in feeding volume', 'feeding interruptions', 'dichotomous mortality and morbidity index (i.e., affirmative for any one of death, late-onset sepsis, necrotizing enterocolitis, chronic lung disease, or severe retinopathy of prematurity), fecal calprotectin, and growth', 'mortality and morbidity index', 'changes in fecal calprotectin, or growth z scores', 'feeding tolerance, reduces morbidity, reduces fecal calprotectin (a measure of gut inflammation', 'feeding tolerance or reduce mortality and morbidity', 'Mean ± SD birth weight']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4517554', 'cui_str': 'One thousand two hundred and fifty'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0580966', 'cui_str': 'Morbidity index (observable entity)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0520459', 'cui_str': 'Necrotizing Enterocolitis'}, {'cui': 'C0746102', 'cui_str': 'Chronic lung disease'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0035344', 'cui_str': 'Retrolental Fibroplasia'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}]",232.0,0.225648,"There was no statistically significant difference in the mortality and morbidity index (48.4% HMBF, 49.2% BMBF, adjusted P = 0.76), changes in fecal calprotectin, or growth z scores.
","[{'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': ""O'Connor"", 'Affiliation': 'Translational Medicine Program and Divisions of Neonatology and Diagnostic Imaging, The Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kiss', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Tomlinson', 'Affiliation': 'Translational Medicine Program and Divisions of Neonatology and Diagnostic Imaging, The Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Bando', 'Affiliation': 'Translational Medicine Program and Divisions of Neonatology and Diagnostic Imaging, The Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Bayliss', 'Affiliation': 'Trillium Health Partners, Mississauga, Canada.'}, {'ForeName': 'Douglas M', 'Initials': 'DM', 'LastName': 'Campbell', 'Affiliation': 'Translational Medicine Program and Divisions of Neonatology, The Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Daneman', 'Affiliation': 'Translational Medicine Program and Divisions of Diagnostic Imaging, The Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Francis', 'Affiliation': 'Translational Medicine Program and Divisions of Neonatology and Diagnostic Imaging, The Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Kotsopoulos', 'Affiliation': 'Department of Pediatrics, Sinai Health System, Toronto, Canada.'}, {'ForeName': 'Prakesh S', 'Initials': 'PS', 'LastName': 'Shah', 'Affiliation': 'Departments of Pediatrics and Medical Imaging, Sunnybrook Research Institute, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Vaz', 'Affiliation': 'Department of Pediatrics, William Osler Health System, Brampton, Canada.'}, {'ForeName': 'Brock', 'Initials': 'B', 'LastName': 'Williams', 'Affiliation': 'Translational Medicine Program and Divisions of Neonatology and Diagnostic Imaging, The Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Unger', 'Affiliation': 'Translational Medicine Program and Divisions of Neonatology, The Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The American journal of clinical nutrition,['10.1093/ajcn/nqy067']
1531,29865903,Decreasing Depression and Anxiety in College Youth Using the Creating Opportunities for Personal Empowerment Program (COPE).,"BACKGROUND


College is a time of major transition in the lives of many young adults. Roughly 30% of college students have reported that anxiety and depressive symptoms negatively affect their lives and academic functioning. Currently, anxiety has surpassed depression as the reason college students seek help at counseling centers. Unfortunately, only one third of students receive treatment for anxiety and only 25% of students receive treatment for their depression.
OBJECTIVES


The objectives of this pilot project were to (a) assess levels of depression and anxiety in identified ""at risk"" college students who present to the college Student Health Services (Primary Care), (b) implement a new cognitive behavioral therapy-based intervention titled ""Creating Opportunities for Personal Empowerment"" (COPE), and (c) evaluate the effectiveness of the intervention on students' levels of depression and anxiety as well as satisfaction with the intervention.
DESIGN


A one group pre- and post-test design was used.
RESULTS


Students who received COPE demonstrated clinically meaningful improvement in depressive and anxiety symptoms as measured by the Beck Depression Inventory-II and the State-Trait Anxiety Inventory.
CONCLUSION


COPE is an effective brief program for reducing depression and anxiety in college-age youth. Implementation of evidenced-based programs into the college experience could lead to less severe depression and anxiety and better academic performance, ultimately increasing the likelihood of students successfully completing their academic programs.",2019,"RESULTS


Students who received COPE demonstrated clinically meaningful improvement in depressive and anxiety symptoms as measured by the Beck Depression Inventory-II and the State-Trait Anxiety Inventory.
","['College Youth', 'college-age youth', 'identified ""at risk"" college students who present to the college Student Health Services (Primary Care), (b) implement a new']","['cognitive behavioral therapy-based intervention titled ""Creating Opportunities for Personal Empowerment"" (COPE', 'COPE']","['Depression and Anxiety', 'depression and anxiety', 'anxiety and depressive symptoms negatively affect their lives and academic functioning', 'depressive and anxiety symptoms', 'severe depression and anxiety and better academic performance', 'Beck Depression Inventory-II and the State-Trait Anxiety Inventory']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0038489', 'cui_str': 'Student Health Services'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0588008', 'cui_str': 'Severe depression (disorder)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0036373', 'cui_str': 'Academic Performance'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",,0.0225179,"RESULTS


Students who received COPE demonstrated clinically meaningful improvement in depressive and anxiety symptoms as measured by the Beck Depression Inventory-II and the State-Trait Anxiety Inventory.
","[{'ForeName': 'Beverly G', 'Initials': 'BG', 'LastName': 'Hart Abney', 'Affiliation': '1 Beverly G. Hart Abney, PhD, APRN-BC, Eastern Kentucky University, Richmond, KY, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Lusk', 'Affiliation': '2 Pamela Lusk, DNP, PMHNP-BC, FAANP, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Hovermale', 'Affiliation': '3 Rachael Hovermale, DNP, APRN-BC, Eastern Kentucky University, Richmond, KY, USA.'}, {'ForeName': 'Bernadette Mazurek', 'Initials': 'BM', 'LastName': 'Melnyk', 'Affiliation': '4 Bernadette Mazurek Melnyk, PhD, RN, CPNP/PMHNP, FAANP, FNAP, FAAN, The Ohio State University, Columbus, OH, USA.'}]",Journal of the American Psychiatric Nurses Association,['10.1177/1078390318779205']
1532,31576376,The Influence of Classroom Physical Activity Participation and Time on Task on Academic Achievement.,"Objectives


Determine the impact of classroom-based physically active lessons on time-on-task. Secondarily, determine the relationship of time-on-task with academic achievement controlling for key demographic variables.
Methods


Seventeen elementary schools were cluster randomized to receive classroom physical activity (A+PAAC, N=9) or control (i.e., no physical activity, N=8) for a 3-year trial. Teachers were trained to deliver physically active lessons with moderate-to-vigorous intensity targeting 100 minutes per week. Outcome measures included academic achievement (Weschler Individual Achievement Test-III), administered at baseline and repeated each spring for 3 years, time spent in moderate-to-vigorous physical activity (MVPA), and time spent on task (TOT) pre- and post-physical activity. Multilevel modeling was utilized to estimate the impacts of percent time spent in MVPA and percent TOT post-lesson on academic achievement and the change in these impacts over 3 years, accounting for dependency among observations and covariates including age, gender, race, free or reduced lunch, BMI, and fitness.
Results


A greater percentage of time performing MVPA were each significantly associated with higher math scores (p=.034) and spelling scores (p<.001), but not reading scores. Academic achievement was not associated with TOT.
Conclusion


Findings suggest that a greater percentage of time spent participating in MVPA results in higher math scores and spelling scores, but not reading scores, independent of TOT. Future studies should continue to evaluate the influence of physically active classroom lessons on time spent on task and its impact on academic achievement. Furthermore, strategies are needed to maximize impact and to determine the sustainability of physical activity's effect on classroom behavior and academic achievement.",2019,"A greater percentage of time performing MVPA were each significantly associated with higher math scores (p=.034) and spelling scores (p<.001), but not reading scores.",['Methods\n\n\nSeventeen elementary schools'],"['classroom-based physically active lessons', 'classroom physical activity (A+PAAC, N=9) or control']","['Classroom Physical Activity Participation and Time on Task on Academic Achievement', 'percentage of time performing MVPA', 'time-on-task', 'spelling scores', 'academic achievement (Weschler Individual Achievement Test-III), administered at baseline and repeated each spring for 3 years, time spent in moderate-to-vigorous physical activity (MVPA), and time spent on task (TOT) pre- and post-physical activity', 'higher math scores']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0556453', 'cui_str': 'Physically active (finding)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0013658', 'cui_str': 'Educational Achievement'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",,0.0319889,"A greater percentage of time performing MVPA were each significantly associated with higher math scores (p=.034) and spelling scores (p<.001), but not reading scores.","[{'ForeName': 'Amanda N', 'Initials': 'AN', 'LastName': 'Szabo-Reed', 'Affiliation': 'Cardiovascular Research Institute, Division of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS, 66160 USA.'}, {'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Willis', 'Affiliation': 'Cardiovascular Research Institute, Division of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS, 66160 USA.'}, {'ForeName': 'Jaehoon', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Educational Psychology and Leadership, Texas Tech University, 2500 Broadway Street; Lubbock, TX 79409 USA.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Hillman', 'Affiliation': 'Department of Psychology, Department of Physical Therapy, Movement, & Rehabilitation Sciences, Northeastern University, 125 NI, 360 Huntington Avenue, Boston, MA, 02115 USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Washburn', 'Affiliation': 'Cardiovascular Research Institute, Division of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS, 66160 USA.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Donnelly', 'Affiliation': 'Cardiovascular Research Institute, Division of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS, 66160 USA.'}]",Translational journal of the American College of Sports Medicine,['10.1249/TJX.0000000000000087']
1533,29696403,"The Effect of a Text Messaging Based HIV Prevention Program on Sexual Minority Male Youths: A National Evaluation of Information, Motivation and Behavioral Skills in a Randomized Controlled Trial of Guy2Guy.","There is a paucity of literature documenting how the constructs of the Information-Motivation-Behavioral Skills (IMB) model are affected by exposure to technology-based HIV prevention programs. Guy2Guy, based on the IMB model, is the first comprehensive HIV prevention program delivered via text messaging and tested nationally among sexual minority adolescent males. Between June and November 2014, 302 14-18 year old gay, bisexual, and/or queer cisgender males were recruited across the US on Facebook and enrolled in a randomized controlled trial testing Guy2Guy versus an attention-matched control program. Among sexually inexperienced youth, those in the intervention were more than three times as likely to be in the ""High motivation"" group at follow-up as control youth (aOR = 3.13; P value = 0.04). The intervention effect was not significant when examined separately for those who were sexually active. HIV information did not significantly vary by experimental arm at 3 months post-intervention end, nor did behavioral skills for condom use or abstinence vary. The increase in motivation to engage in HIV preventive behavior for adolescent males with no prior sexual experience is promising, highlighting the need to tailor HIV prevention according to past sexual experience. The behavioral skills that were measured may not have reflected those most emphasized in the content (e.g., how to use lubrication to reduce risk and increase pleasure), which may explain the lack of detected intervention impact.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov ID# NCT02113956.",2018,"HIV information did not significantly vary by experimental arm at 3 months post-intervention end, nor did behavioral skills for condom use or abstinence vary.","['Sexual Minority Male Youths', 'sexual minority adolescent males', 'and/or queer cisgender males', 'Between June and November 2014, 302 14-18\xa0year old gay, bisexual', 'adolescent males with no prior sexual experience']","['Guy2Guy versus an attention-matched control program', 'Guy2Guy', 'Text Messaging Based HIV Prevention Program']",['motivation to engage in HIV preventive behavior'],"[{'cui': 'C4277573', 'cui_str': 'Sexual and Gender Minorities'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0019898', 'cui_str': 'Queers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C2129310', 'cui_str': 'Bisexual (finding)'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.0444039,"HIV information did not significantly vary by experimental arm at 3 months post-intervention end, nor did behavioral skills for condom use or abstinence vary.","[{'ForeName': 'Michele L', 'Initials': 'ML', 'LastName': 'Ybarra', 'Affiliation': 'Center for Innovative Public Health Research, 555 El Camino Real #A347, San Clemente, CA, 92672, USA. Michele@InnovativePublicHealth.org.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'NORC at the University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Tonya L', 'Initials': 'TL', 'LastName': 'Prescott', 'Affiliation': 'Center for Innovative Public Health Research, 555 El Camino Real #A347, San Clemente, CA, 92672, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Phillips', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Mustanski', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}]",AIDS and behavior,['10.1007/s10461-018-2118-1']
1534,29602791,Endogenous Glucose Production and Hormonal Changes in Response to Canagliflozin and Liraglutide Combination Therapy.,"The decrement in plasma glucose concentration with SGLT2 inhibitors (SGLT2i) is blunted by a rise in endogenous glucose production (EGP). We investigated the ability of incretin treatment to offset the EGP increase. Subjects with type 2 diabetes ( n  = 36) were randomized to  1 ) canagliflozin (CANA),  2 ) liraglutide (LIRA), or  3 ) CANA plus LIRA (CANA/LIRA). EGP was measured with [3- 3 H]glucose with or without drugs for 360 min. In the pretreatment studies, EGP was comparable and decreased (2.2 ± 0.1 to 1.7 ± 0.2 mg/kg ⋅ min) during a 300- to 360-min period ( P  < 0.01). The decrement in EGP was attenuated with CANA (2.1 ± 0.1 to 1.9 ± 0.1 mg/kg ⋅ min) and CANA/LIRA (2.2 ± 0.1 to 2.0 ± 0.1 mg/kg ⋅ min), whereas with LIRA it was the same (2.4 ± 0.2 to 1.8 ± 0.2 mg/kg ⋅ min) (all  P  < 0.05 vs. baseline). After CANA, the fasting plasma insulin concentration decreased (18 ± 2 to 12 ± 2 μU/mL,  P  < 0.05), while it remained unchanged in LIRA (18 ± 2 vs. 16 ± 2 μU/mL) and CANA/LIRA (17 ± 1 vs. 15 ± 2 μU/mL). Mean plasma glucagon did not change during the pretreatment studies from 0 to 360 min, while it increased with CANA (69 ± 3 to 78 ± 2 pg/mL,  P  < 0.05), decreased with LIRA (93 ± 6 to 80 ± 6 pg/mL,  P  < 0.05), and did not change in CANA/LIRA. LIRA prevented the insulin decline and blocked the glucagon rise observed with CANA but did not inhibit the increase in EGP. Factors other than insulin and glucagon contribute to the stimulation of EGP after CANA-induced glucosuria.",2018,LIRA prevented the insulin decline and blocked the glucagon rise observed with CANA but did not inhibit the increase in EGP.,['Subjects with type 2 diabetes ( n  = 36'],"['LIRA', 'CANA plus LIRA (CANA/LIRA', 'canagliflozin (CANA),  2 ) liraglutide (LIRA), or  3 ']","['fasting plasma insulin concentration', 'glucagon rise', 'EGP', 'plasma glucose concentration', 'Mean plasma glucagon']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1278023', 'cui_str': 'Plasma glucagon measurement'}]",36.0,0.0207609,LIRA prevented the insulin decline and blocked the glucagon rise observed with CANA but did not inhibit the increase in EGP.,"[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Martinez', 'Affiliation': 'Division of Diabetes, Department of Medicine, University of Texas Health Science Center and Texas Diabetes Institute, University Health System, San Antonio, TX.'}, {'ForeName': 'Hussein', 'Initials': 'H', 'LastName': 'Al-Jobori', 'Affiliation': 'Division of Diabetes, Department of Medicine, University of Texas Health Science Center and Texas Diabetes Institute, University Health System, San Antonio, TX.'}, {'ForeName': 'Ali M', 'Initials': 'AM', 'LastName': 'Ali', 'Affiliation': 'Division of Diabetes, Department of Medicine, University of Texas Health Science Center and Texas Diabetes Institute, University Health System, San Antonio, TX.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Adams', 'Affiliation': 'Division of Diabetes, Department of Medicine, University of Texas Health Science Center and Texas Diabetes Institute, University Health System, San Antonio, TX.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Abdul-Ghani', 'Affiliation': 'Division of Diabetes, Department of Medicine, University of Texas Health Science Center and Texas Diabetes Institute, University Health System, San Antonio, TX.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Triplitt', 'Affiliation': 'Division of Diabetes, Department of Medicine, University of Texas Health Science Center and Texas Diabetes Institute, University Health System, San Antonio, TX.'}, {'ForeName': 'Ralph A', 'Initials': 'RA', 'LastName': 'DeFronzo', 'Affiliation': 'Division of Diabetes, Department of Medicine, University of Texas Health Science Center and Texas Diabetes Institute, University Health System, San Antonio, TX albarado@uthscsa.edu.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Cersosimo', 'Affiliation': 'Division of Diabetes, Department of Medicine, University of Texas Health Science Center and Texas Diabetes Institute, University Health System, San Antonio, TX.'}]",Diabetes,['10.2337/db17-1278']
1535,24667722,Factors affecting surgical management following neoadjuvant therapy in patients with primary HER2-positive breast cancer: results from the NeoALTTO phase III trial.,,2014,,['patients with primary HER2-positive breast cancer'],['neoadjuvant therapy'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant Treatment'}]",[],,0.0169903,,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Criscitiello', 'Affiliation': 'Department of Medical Oncology, Istituto Europeo di Oncologia, Milan, Italy. Electronic address: carmen.criscitiello@ieo.it.'}, {'ForeName': 'H A', 'Initials': 'HA', 'LastName': 'Azim', 'Affiliation': 'BrEAST Data Centre and Department of Medicine, Clinical Oncology, Brussels, Belgium.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'de Azambuja', 'Affiliation': 'BrEAST Data Centre and Department of Medicine, Clinical Oncology, Brussels, Belgium.'}, {'ForeName': 'I T', 'Initials': 'IT', 'LastName': 'Rubio', 'Affiliation': ""Breast Surgical Onclogy Unit, Universitario Vall D'Hebron, Barcelona, Spain.""}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu034']
1536,29867624,Approximate Arithmetic Training Improves Informal Math Performance in Low Achieving Preschoolers.,"Recent studies suggest that practice with approximate and non-symbolic arithmetic problems improves the math performance of adults, school aged children, and preschoolers. However, the relative effectiveness of approximate arithmetic training compared to available educational games, and the type of math skills that approximate arithmetic targets are unknown. The present study was designed to (1) compare the effectiveness of approximate arithmetic training to two commercially available numeral and letter identification tablet applications and (2) to examine the specific type of math skills that benefit from approximate arithmetic training. Preschool children ( n  = 158) were pseudo-randomly assigned to one of three conditions: approximate arithmetic, letter identification, or numeral identification. All children were trained for 10 short sessions and given pre and post tests of informal and formal math, executive function, short term memory, vocabulary, alphabet knowledge, and number word knowledge. We found a significant interaction between initial math performance and training condition, such that children with low pretest math performance benefited from approximate arithmetic training, and children with high pretest math performance benefited from symbol identification training. This effect was restricted to informal, and not formal, math problems. There were also effects of gender, socio-economic status, and age on post-test informal math score after intervention. A median split on pretest math ability indicated that children in the low half of math scores in the approximate arithmetic training condition performed significantly better than children in the letter identification training condition on post-test informal math problems when controlling for pretest, age, gender, and socio-economic status. Our results support the conclusion that approximate arithmetic training may be especially effective for children with low math skills, and that approximate arithmetic training improves early informal, but not formal, math skills.",2018,"Recent studies suggest that practice with approximate and non-symbolic arithmetic problems improves the math performance of adults, school aged children, and preschoolers.","['Low Achieving Preschoolers', 'children with low math skills', 'Preschool children ( n  = 158', 'adults, school aged children, and preschoolers']","['Approximate Arithmetic Training', 'approximate arithmetic training', 'approximate arithmetic, letter identification, or numeral identification']",['Informal Math Performance'],"[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C1720186', 'cui_str': 'Numeral'}]",[],158.0,0.0199191,"Recent studies suggest that practice with approximate and non-symbolic arithmetic problems improves the math performance of adults, school aged children, and preschoolers.","[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Szkudlarek', 'Affiliation': 'Department of Psychology, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Brannon', 'Affiliation': 'Department of Psychology, University of Pennsylvania, Philadelphia, PA, United States.'}]",Frontiers in psychology,['10.3389/fpsyg.2018.00606']
1537,31208770,"Impact of ""opening the lung"" ventilatory strategy on burn patients with acute respiratory distress syndrome.","OBJECTIVE


The objective of this study was to investigate the feasibility and influence of opening the lung strategy ventilation on burned patients complicated with ARDS.
METHODS


A prospective study was carried out in 66 moderate to severe burned patients also presented with ARDS who were randomly divided into the control group (ventilated as ARDS net) and the study group (ventilated with open lung strategy). All patients were ventilated with volume control mode until weaning.
RESULTS


Opening the lung procedure was safe in all patients with optimal PEEP of 14.8 ± 1.8 cmH 2 O. After 24 h of lung recruitment and PEEP titration, oxygenation significantly improved (PaO 2 /FiO 2  ratio increased from 119.8 ± 7.4 to 263.4 ± 11.6; p < 0.01). Along the time, the absolute values of static compliances in the study group were significantly higher (33.9 ± 0.9 vs. 26.3 ± 0.6 at 1st day; 48.4 ± 1.5 vs. 35.7 ± 0.8 at 3rd day; 48.2 ± 1.5 vs. 42.6 ± 1 at 5th day and 53.2 ± 1.8 vs. 45.3 ± 2.3 at 7th day). In addition, within the first 5 days of ventilation, PaO 2 /FiO 2  ratio significantly increased in both groups (p < 0.05) but a faster rate was recorded in the study group (176.2 ± 11.9 vs. 152.1 ± 7.5 at 1st day; 284.2 ± 16.7 vs. 210.8 ± 15.3 at 3rd day and 302.2 ± 21 vs. 233.7 ± 22.4 at 5th day, p < 0.05). Number of ventilator-free days during the first 28-days after burn injury was significantly higher in the study group (12.9 ± 5.7 vs. 9.5 ± 5.9 days; p < 0.05). Ventilation time, lengths of stay in the ICU and hospital length of stay were not significantly different across both groups (p > 0.05). In addition, duration time from ADRS onset to death and from admission to death were also remarkably longer in the study group (p < 0.05). Mortality rate was significant lower in the study group (24.2% vs. 63.6%; p < 0.01) within 7 days since onset of ARDS, but not significantly different after two weeks as well as at the 28th day after burns injury. Overall mortality rate was also not significant difference between two groups.
CONCLUSION


It is necessary to conduct further trials to find out the effectiveness of this ventilation strategy on burns injury induced ARDS.",2019,"Ventilation time, lengths of stay in the ICU and hospital length of stay were not significantly different across both groups (p > 0.05).","['All patients were ventilated with volume control mode until weaning', 'burned patients complicated with ARDS', '66 moderate to severe burned patients also presented with ARDS', 'burn patients with acute respiratory distress syndrome']","['opening the lung strategy ventilation', 'opening the lung"" ventilatory strategy', 'control group (ventilated as ARDS net) and the study group (ventilated with open lung strategy']","['Ventilation time, lengths of stay in the ICU and hospital length of stay', 'absolute values of static compliances', 'faster rate', 'duration time from ADRS onset to death and from admission to death', 'lung recruitment and PEEP titration, oxygenation significantly improved (PaO 2 /FiO 2  ratio', 'Mortality rate', 'Number of ventilator-free days', 'Overall mortality rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0449972', 'cui_str': 'Volume control (attribute)'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0429681', 'cui_str': 'Static lung compliance'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0863179', 'cui_str': 'Peeping'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0353079,"Ventilation time, lengths of stay in the ICU and hospital length of stay were not significantly different across both groups (p > 0.05).","[{'ForeName': 'Nguyen Nhu', 'Initials': 'NN', 'LastName': 'Lam', 'Affiliation': 'National Burn Hospital, Hanoi, Viet Nam. Electronic address: lamnguyenau@yahoo.com.'}, {'ForeName': 'Tran Dinh', 'Initials': 'TD', 'LastName': 'Hung', 'Affiliation': 'National Burn Hospital, Hanoi, Viet Nam.'}, {'ForeName': 'Dong Khac', 'Initials': 'DK', 'LastName': 'Hung', 'Affiliation': 'Military Medical University, Hanoi, Viet Nam.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2019.05.016']
1538,24608195,Letter to the editor on 'Factors associated with surgical management following neoadjuvant therapy in patients with primary HER2-positive breast cancer: results from the NeoALTTO phase III trial'.,,2014,,['patients with primary HER2-positive breast cancer'],['neoadjuvant therapy'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant Treatment'}]",[],,0.0140147,,"[{'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Barry', 'Affiliation': 'Breast Unit, The Royal Marsden NHS Foundation Trust, London;; The Institute of Cancer Research, London, UK. Electronic address: peter.barry@icr.ac.uk.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Schiavon', 'Affiliation': 'Breast Unit, The Royal Marsden NHS Foundation Trust, London;; The Institute of Cancer Research, London, UK.'}, {'ForeName': 'F A', 'Initials': 'FA', 'LastName': 'MacNeill', 'Affiliation': 'Breast Unit, The Royal Marsden NHS Foundation Trust, London.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu030']
1539,29619333,"Role of opioids as coinduction agent with propofol and their effect on apnea time, recovery time, and sedation score.","Background


Laryngeal mask airway (LMA) is a supraglottic device which requires lesser depth of anaesthesia, evokes lesser hemodynamic response and causes lesser stimulation of airway as compared to traditional definitive airway device endotracheal tube. Its placement is possible without muscle relaxants thereby allowing maintenance of anaesthesia on spontaneous respiration thus preventing apnoea or minimizing apnoea time. Propofol, the commonly used induction agent, causes cardiorespiratory depression at higher induction doses. To attenuate this, co-induction agents combined with propofol has been a regular I/V anaesthetic technique these days.
Aim


Comparing apnoea time, recovery time and sedation scores using propofol-fentanyl and propofol-butorphanol combination.
Methodology


Hundred patients scheduled for various elective surgical procedures were randomly selected and divided into two groups of 50 each. As coinduction drug Group F received fentanyl and Group B received butorphanol. In both the groups induction was achieved with I/V propofol and LMA was placed. Apnoea time was noted after induction. Recovery time and sedation scores were recorded after anaesthetic agents were turned off.
Results


As compared to group F apnoea time was significantly less and recovery time was significantly more in group B ( P  < 0.05). Statistically postoperative sedation was significantly higher in group B than in group F at 1/2 hr but clinically, majority were responding to verbal commands. At 1 hour no significant difference in sedation was noted between the groups.
Conclusion


Considering respiratory and recovery profile propofol -butorphanol combination is a safer alternative to propofol-fentanyl combination for LMA insertion.",2018,As compared to group F apnoea time was significantly less and recovery time was significantly more in group B ( P  < 0.05).,['Methodology\n\n\nHundred patients scheduled for various elective surgical procedures'],"['butorphanol combination', 'butorphanol', '\n\n\nLaryngeal mask airway (LMA', 'fentanyl', 'propofol', 'propofol-fentanyl and propofol-butorphanol combination', 'Propofol']","['apnea time, recovery time, and sedation score', 'Statistically postoperative sedation', 'sedation', 'Apnoea time', 'recovery time', 'apnoea time, recovery time and sedation scores', 'F apnoea time', 'Recovery time and sedation scores']","[{'cui': 'C0969625', 'cui_str': 'methodology'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}]","[{'cui': 'C0006491', 'cui_str': 'Butorphanol'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",0.0,0.0149977,As compared to group F apnoea time was significantly less and recovery time was significantly more in group B ( P  < 0.05).,"[{'ForeName': 'Manisha Bhatt', 'Initials': 'MB', 'LastName': 'Dwivedi', 'Affiliation': 'Department of Anaesthesiology, MMIMSR, Ambala, Haryana, India.'}, {'ForeName': 'Anisha', 'Initials': 'A', 'LastName': 'Puri', 'Affiliation': 'Department of Anaesthesiology, MMIMSR, Ambala, Haryana, India.'}, {'ForeName': 'Sankalp', 'Initials': 'S', 'LastName': 'Dwivedi', 'Affiliation': 'Department of General Surgery, MMIMSR, Ambala, Haryana, India.'}, {'ForeName': 'Harinder', 'Initials': 'H', 'LastName': 'Deol', 'Affiliation': 'Department of Anaesthesiology, MMIMSR, Ambala, Haryana, India.'}]",International journal of critical illness and injury science,['10.4103/IJCIIS.IJCIIS_4_17']
1540,29619335,Role of neomycin polymyxin sulfate solution bladder wash for prevention of catheter associated urinary tract infection in traumatic brain injury patient admitted to Intensive Care Unit: A prospective randomized study.,"Background


Catheter - associated urinary tract infection (CAUTI) remains a critical threat for patients in intensive care unit especially in traumatic brain injury patients with low Glasgow coma score (GCS). Almost all patients in ICU receive antibiotic either prophylactic or therapeutic based on local antibiogram of particular ICU or hospital. For prophylaxis, systemic antibiotics are used. It will be helpful to avoid systemic side effects by introducing antibiotics locally through bladder irrigation. The indwelling urinary catheter is an essential part of modern medical care.
Aims and Objectives


The primary objective was to study the effect of Neomycin and Polymyxin sulphate solution for bladder wash on CAUTI in traumatic brain injury patients. The secondary objectives was to study the various organisms causing CAUTI and their antibiotic sensitivity and resistance pattern.
Materials and Methods


This was a prospective randomized controlled study performed on 100 patients who met the inclusion criteria at the trauma intensive care unit of Banaras Hindu University between September and February 2016. The patients were randomized into two groups - one was the study group which received Neomycin and Polymyxin Sulphate solution bladder wash, while the other was the control group that received Normal saline bladder wash. Urine samples were collected at certain days and sent for culture and sensitivity.
Results


There was significant reduction in the incidence of CAUTI in neomycin/polymyxin test group in comparison to normal saline irrigated control group. Out of 50 patients in test group 8 patients and in control group 26 patients was identified as CAUTI positive and they were statistically significant. In our study pseudomonas aeruginosa (51%) was the commonest isolated pathogen.
Conclusions


Neomycin and Polymyxin Sulphate bladder wash was effective in preventing CAUTI. It can thus decrease the antibiotic usage thereby preventing the emergence of antibiotic resistance.",2018,There was significant reduction in the incidence of CAUTI in neomycin/polymyxin test group in comparison to normal saline irrigated control group.,"['traumatic brain injury patients', 'traumatic brain injury patient admitted to Intensive Care Unit', '100 patients who met the inclusion criteria at the trauma intensive care unit of Banaras Hindu University between September and February 2016', 'patients in intensive care unit especially in traumatic brain injury patients with low Glasgow coma score (GCS']","['neomycin polymyxin sulfate solution bladder', 'Neomycin and Polymyxin Sulphate solution bladder', 'Polymyxin Sulphate bladder', 'Neomycin and Polymyxin sulphate solution', 'Normal saline bladder wash', '\n\n\nCatheter - associated urinary tract infection (CAUTI']","['incidence of CAUTI', 'various organisms causing CAUTI and their antibiotic sensitivity and resistance pattern']","[{'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0583239', 'cui_str': 'Admission to intensive care unit (procedure)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4047661', 'cui_str': 'Trauma ICU'}, {'cui': 'C0425335', 'cui_str': 'Hindu, follower of religion (person)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1271007', 'cui_str': 'Glasgow coma score finding'}]","[{'cui': 'C0027603', 'cui_str': 'Neomycin'}, {'cui': 'C0032539', 'cui_str': 'Polymyxins'}, {'cui': 'C0038720', 'cui_str': 'Sulfates, Inorganic'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C1547959', 'cui_str': 'Wash - dosing instruction imperative'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0029235', 'cui_str': 'Organism - attribute'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]",100.0,0.0709803,There was significant reduction in the incidence of CAUTI in neomycin/polymyxin test group in comparison to normal saline irrigated control group.,"[{'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Kumar', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Trauma Center Intensive Care Unit, BHU, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Yashpal', 'Initials': 'Y', 'LastName': 'Singh', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Trauma Center Intensive Care Unit, BHU, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Ghanshyam', 'Initials': 'G', 'LastName': 'Yadav', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Trauma Center Intensive Care Unit, BHU, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Mathur', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Trauma Center Intensive Care Unit, BHU, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Umesh Kumar', 'Initials': 'UK', 'LastName': 'Bhadani', 'Affiliation': 'Department of Anaesthesiology, AllInstitute of Medical Sciences, Patna, Bihar, India.'}]",International journal of critical illness and injury science,['10.4103/IJCIIS.IJCIIS_24_17']
1541,31636243,Effects of adding dexmedetomidine to local infiltration of bupivacaine on postoperative pain in pediatric herniorrhaphy: a randomized clinical trial.,"BACKGROUND


Postoperative pain is a major problem, especially in children, as their tolerance level is lower and several drugs are contraindicated in childhood. This study aimed to compare the effect of dexmedetomidine added to local infiltration of bupivacaine for postoperative pain relief in children undergoing inguinal herniorrhaphy.
METHODS


This double-blind, randomized clinical trial included 60 children aged 6-72 months undergoing unilateral herniorrhaphy at selected hospitals in Shiraz, Iran, randomly allocated into two groups, 30 in each group. One group received 1 µg/kg dexmedetomidine plus local infiltration of 0.2 ml/kg bupivacaine 0.5% at the incision site before surgery (BD), and the other group received bupivacaine and normal saline (BO). Analgesic requirements, emergence time, and nausea/vomiting, postoperative pain and sedation scores were assessed for 4 h after the operation. Heart rate (HR), systolic blood pressure (SBP), and oxygen saturation (SaO2) were recorded at baseline, and at 10 and 20 min after injection.
RESULTS


Eighty percent were boy in each group; mean age was 22.75 ± 18.63 months. SaO2 and SBP were not different between the groups, while HR was significantly lower in the BD group at 10 and 20 min after injection (P <0.05). BD group had a lower pain score at 1 and 2 h after the operation, a higher sedation score at the first three time intervals, and longer emergence time than BO group (all P <0.001). BD group had a lower pain score at 1 and 2 h after the operation (P < 0.001, P < 0.047 respectively).
CONCLUSIONS


Addition of dexmedetomidine to local infiltration of bupivacaine in children undergoing herniorrhaphy significantly reduced postoperative pain and increased sedation.",2020,"There was no difference between the groups regarding SaO2 and SBP, while HR was significantly lower in BD group after 10 and 20 minutes (P<0.05).","['children undergoing inguinal herniorrhaphy', '60 patients were recruited in the study, 30 in each group', '24 patients (80%) were boys and 6 (20%) were girls', 'children undergoing', '60 children aged 6-72 months undergoing unilateral herniorrhaphy at selected hospitals, Shiraz, Iran', 'Pediatric Herniorrhaphy']","['herniorrhaphy', 'dexmedetomidine', 'Dexmedetomidine', 'bupivacaine and normal saline (BO', 'dexmedetomidine plus local infiltration of 0.2 mL/kg bupivacaine', 'bupivacaine', 'Bupivacaine']","['postoperative pain', 'pain score', 'Heart rate (HR), systolic blood pressure (SBP), and arterial oxygen saturation (SaO2', 'Postoperative pain and sedation score', 'Analgesic requirements, emergence time, and nausea/vomiting', 'Postoperative Pain', 'Sedation score', 'emergence time', 'SaO2 and SBP, while HR']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0019328', 'cui_str': 'Hernia Repair'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C0019328', 'cui_str': 'Hernia Repair'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C2711000', 'cui_str': 'SaO2 - Arterial oxygen saturation'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}]",60.0,0.299113,"There was no difference between the groups regarding SaO2 and SBP, while HR was significantly lower in BD group after 10 and 20 minutes (P<0.05).","[{'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Azemati', 'Affiliation': 'Department of Anesthesiology and Intensive Care Unit, Medical College, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Pourali', 'Affiliation': 'Department of Anesthesiology and Intensive Care Unit, Medical College, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Sedigheh', 'Initials': 'S', 'LastName': 'Aghazadeh', 'Affiliation': 'Department of Anesthesiology and Intensive Care Unit, Medical College, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Korean journal of anesthesiology,['10.4097/kja.19111']
1542,31641831,Effects of public versus media responsibility messages on stigmatization of people with schizophrenia in an American adult sample.,"PURPOSE


People with mental illness suffer from the consequences of stigma. Interventions to reduce stigma should focus on alternative approaches that target false beliefs toward mental disorders. The effectiveness of two messages to reduce stigma toward schizophrenia was tested: a traditional public responsibility message that attributes stigma to public misunderstandings, and an alternative media responsibility message that attributes stigma to bias in media representations.
METHODS


An experiment with Americans (N = 448) randomly assigned to a public responsibility message, a media responsibility message, or a control condition. Participants in the two message conditions completed measures of guilt and reactance toward the media. Perceptions of personal responsibility and dangerousness, and social rejection intentions were assessed for all participants.
RESULTS


Both messages lowered perceptions of dangerousness and social rejection intentions, relative to control. The media responsibility generated more reactance toward the media than the public responsibility approach, but not more guilt. Reactance did not mediate message effects. Perceptions of personal responsibility were reduced after exposure to the public responsibility message, but only for participants with no prior contact with mental illness.
CONCLUSIONS


Both approaches reduced perceptions of dangerousness and social rejection intentions. Stigma reduction campaigns might segment the audience based on prior contact.",2020,"Perceptions of personal responsibility were reduced after exposure to the public responsibility message, but only for participants with no prior contact with mental illness.
","['people with schizophrenia in an American adult sample', 'participants with no prior contact with mental illness', 'People with mental illness suffer from the consequences of stigma']","['public versus media responsibility messages', 'public responsibility message, a media responsibility message, or a control condition']","['guilt and reactance toward the media', 'perceptions of dangerousness and social rejection intentions', 'Perceptions of personal responsibility and dangerousness, and social rejection intentions']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0332158', 'cui_str': 'Contact with (contextual qualifier) (qualifier value)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0686907', 'cui_str': 'Consequence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}]","[{'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0018379', 'cui_str': 'Guilt'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0010968', 'cui_str': 'Dangerousness'}, {'cui': 'C0237827', 'cui_str': 'Social Rejection'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",448.0,0.0249898,"Perceptions of personal responsibility were reduced after exposure to the public responsibility message, but only for participants with no prior contact with mental illness.
","[{'ForeName': 'Thais M', 'Initials': 'TM', 'LastName': 'Zimbres', 'Affiliation': 'Department of Communication, University of California Davis, One Shields Ave., Davis, CA, 95616, USA. zimbres@ucdavis.edu.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Bell', 'Affiliation': 'Department of Communication, University of California Davis, One Shields Ave., Davis, CA, 95616, USA.'}, {'ForeName': 'Laramie D', 'Initials': 'LD', 'LastName': 'Taylor', 'Affiliation': 'Department of Communication, University of California Davis, One Shields Ave., Davis, CA, 95616, USA.'}]",Social psychiatry and psychiatric epidemiology,['10.1007/s00127-019-01788-6']
1543,29750251,"Effect of Aerobic Exercise Training and Essential Amino Acid Supplementation for 24 Weeks on Physical Function, Body Composition, and Muscle Metabolism in Healthy, Independent Older Adults: A Randomized Clinical Trial.","BACKGROUND


Essential amino acids (EAA) and aerobic exercise (AE) acutely and independently stimulate skeletal muscle protein anabolism in older adults.
OBJECTIVE


In this Phase 1, double-blind, placebo-controlled, randomized clinical trial, we determined if chronic EAA supplementation, AE training, or a combination of the two interventions could improve muscle mass and function by stimulating muscle protein synthesis.
METHODS


We phone-screened 971, enrolled 109, and randomized 50 independent, low-active, nonfrail, and nondiabetic older adults (age 72 ± 1 years). We used a 2 × 2 factorial design. The interventions were: daily nutritional supplementation (15 g EAA or placebo) and physical activity (supervised AE training 3 days/week or monitored habitual activity) for 24 weeks. Muscle strength, physical function, body composition, and muscle protein synthesis were measured before and after the 24-week intervention.
RESULTS


Forty-five subjects completed the 24-week intervention. VO2peak and walking speed increased (p < .05) in both AE groups, irrespective of supplementation type, but muscle strength increased only in the EAA + AE group (p < .05). EAA supplementation acutely increased (p < .05) muscle protein synthesis from basal both before and after the intervention, with a larger increase in the EAA + AE group after the intervention. Total and regional lean body mass did not change significantly with any intervention.
CONCLUSIONS


In nonfrail, independent, healthy older adults AE training increased walking speed and aerobic fitness, and, when combined with EAA supplementation, it also increased muscle strength and EAA-stimulated muscle protein synthesis. These increases occurred without improvements in muscle mass.",2019,"EAA supplementation acutely increased (p<0.05) muscle protein synthesis from basal both before and after the intervention, with a larger increase in the EAA+AE group after the intervention.","['We phone screened 971, enrolled 109, and randomized 50 independent, low-active, non-frail, non-diabetic older adults (age 72±1 yrs', '45 subjects completed the 24-week intervention', 'Healthy', 'older adults', 'Independent Older Adults']","['Aerobic Exercise Training and Essential Amino Acid Supplementation', 'daily nutritional supplementation (15 g EAA or placebo) and physical activity (supervised AE training three days/week or monitored habitual activity', 'placebo', '\n\n\nEssential amino acids (EAA) and aerobic exercise (AE']","['Physical Function, Body Composition and Muscle Metabolism', 'Total and regional lean body mass', 'muscle strength', 'walking speed and aerobic fitness', 'EAA supplementation acutely increased (p<0.05) muscle protein synthesis', 'VO2peak and walking speed', 'Muscle strength, physical function, body composition, and muscle protein synthesis']","[{'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0556083', 'cui_str': 'Essential amino acid supplementation (product)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplement'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0677547', 'cui_str': 'days/week (qualifier value)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0002525', 'cui_str': 'Amino Acids, Essential'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0026832', 'cui_str': 'Muscle Proteins'}]",971.0,0.0724258,"EAA supplementation acutely increased (p<0.05) muscle protein synthesis from basal both before and after the intervention, with a larger increase in the EAA+AE group after the intervention.","[{'ForeName': 'Melissa M', 'Initials': 'MM', 'LastName': 'Markofski', 'Affiliation': 'Sealy Center on Aging, University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Kristofer', 'Initials': 'K', 'LastName': 'Jennings', 'Affiliation': 'Department of Preventive Medicine and Community Health, University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Kyle L', 'Initials': 'KL', 'LastName': 'Timmerman', 'Affiliation': 'Sealy Center on Aging, University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Dickinson', 'Affiliation': 'Department of Nutrition and Metabolism, University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Fry', 'Affiliation': 'Sealy Center on Aging, University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Borack', 'Affiliation': 'Division of Rehabilitation Sciences, University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Reidy', 'Affiliation': 'Division of Rehabilitation Sciences, University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Rachel R', 'Initials': 'RR', 'LastName': 'Deer', 'Affiliation': 'Sealy Center on Aging, University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Randolph', 'Affiliation': 'Sealy Center on Aging, University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Blake B', 'Initials': 'BB', 'LastName': 'Rasmussen', 'Affiliation': 'Sealy Center on Aging, University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Volpi', 'Affiliation': 'Sealy Center on Aging, University of Texas Medical Branch, Galveston.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/gly109']
1544,31431236,"Quality of Life, Fatigue, and Sleep Problems in Pancreatic Cancer Patients—A Randomized Trial on the Effects of Exercise","BACKGROUND


Improving quality of life (QoL) is an important treatment goal in pancreatic cancer patients. Although the beneficial effects of exercise on QoL are well understood, few studies have investigated more aggressive cancers such as pancreatic cancer.
METHODS


Within a randomized trial, we assessed the efficacy of 6-month resistance training on physical functioning (primary outcome) and further QoL-related outcomes. 65 pancreatic cancer patients were assigned to home-based training, supervised training, or a usual care control group. Analysis-of-covariance models on changes from baseline to 6 and 3 months were ap- plied.
RESULTS


47 patients completed the intervention period. After 6 months, no effects of resistance training were observed. However, after 3 months, explorative analyses showed significant between-group mean differences (MD) in favor for resistance training for physical functioning (pooled group: MD=11.0; p=0.016; effect size[ES]=0.31), as well as for global QoL (MD=12.1; p=0.016; effect size=0.56), and other outcomes, such as sleep problems and fatigue. Multiple imputation analyses yielded similar results. Home-based and supervised training performed similarly.
CONCLUSION


This first randomized resistance training trial in pancreatic cancer patients indicated clinically relevant improve- ments in QoL after 3 but not after 6 months. Given the severity of pancreatic cancer, exercise recommendations may already commence at surgery.",2019,This first randomized resistance training trial in pancreatic cancer patients indicated clinically relevant improve- ments in QoL after 3 but not after 6 months.,"['pancreatic cancer patients', '65 pancreatic cancer patients', 'Pancreatic Cancer Patients', '47 patients completed the intervention period']","['Exercise', 'Home-based and supervised training performed similarly', 'home-based training, supervised training, or a usual care control group', 'resistance training']","['Quality of Life, Fatigue, and Sleep Problems', 'sleep problems and fatigue', 'resistance training']","[{'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0034380'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]",65.0,0.0849304,This first randomized resistance training trial in pancreatic cancer patients indicated clinically relevant improve- ments in QoL after 3 but not after 6 months.,"[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Steindorf', 'Affiliation': 'Division of Physical Activity, Prevention and Cancer, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT) Heidelberg, Germany'}, {'ForeName': 'Dorothea', 'Initials': 'D', 'LastName': 'Clauss', 'Affiliation': 'Division of Physical Activity, Prevention and Cancer, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT) Heidelberg, Germany'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Tjaden', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, German'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Hackert', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, German'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Herbolsheimer', 'Affiliation': 'Division of Physical Activity, Prevention and Cancer, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT) Heidelberg, Germany'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bruckner', 'Affiliation': 'Institute for Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Schneider', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, German'}, {'ForeName': 'Cornelia M', 'Initials': 'CM', 'LastName': 'Ulrich', 'Affiliation': 'Department of Population Health Sciences, Huntsman Cancer Institute and University of Utah, Salt Lake City, USA'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Wiskemann', 'Affiliation': 'Division of Medical Oncology, National Center for Tumor Diseases and Heidelberg University Hospital, Heidelberg, Germany'}]",Deutsches Arzteblatt international,['10.3238/arztebl.2019.0471']
1545,30001244,Pregnancy outcomes and infant growth among babies with in-utero exposure to tenofovir-based preexposure prophylaxis for HIV prevention.,"BACKGROUND


Global guidelines recommend preexposure prophylaxis (PrEP) use by women at risk for HIV, including during pregnancy, a period with heightened HIV risk. However, data to support safety of PrEP use during pregnancy are limited, particularly from women using PrEP throughout pregnancy.
METHODS


In an open-label delivery study of PrEP integrated with ART for high-risk HIV serodiscordant couples in Kenya and Uganda (the Partners Demonstration Project), women who became pregnant while using PrEP were offered the option to continue PrEP throughout pregnancy. We compared pregnancy outcomes and 1-year infant growth from pregnancies with exposure to PrEP throughout pregnancy to those without any exposure, with data from the placebo arm of a prior efficacy trial of PrEP conducted in the same setting.
RESULTS


Outcomes from 30 women who elected to continue PrEP throughout pregnancy were compared with those from 96 pregnancies among PrEP-unexposed women. There were small nonsignificant decreases in the frequency of pregnancy loss [16.7% PrEP-exposed versus 23.5% PrEP-unexposed, adjusted odds ratio (aOR) = 0.59, P = 0.4] and preterm delivery [0 versus 7.7%, (aOR) = 0.54, exact P = 0.6]. No congenital anomalies occurred among PrEP-exposed infants. PrEP-exposed infants had slightly lower adjusted mean z-scores for length (-1.73 versus -0.79, P = 0.05) and head circumference (0.24 versus 1.07, P = 0.04) 1 month after birth but were comparable to PrEP-unexposed infants in these measurements 1 year after birth.
CONCLUSION


This first evaluation among women using PrEP throughout pregnancy indicates no greater frequency of adverse pregnancy outcomes or restricted infant growth; these findings support recommendations permitting PrEP use during pregnancy.",2018,This first evaluation among women using PrEP throughout pregnancy indicates no greater frequency of adverse pregnancy outcomes or restricted infant growth; these findings support recommendations permitting PrEP use during pregnancy.,"['high-risk HIV serodiscordant couples in Kenya and Uganda (the Partners Demonstration Project), women who became pregnant while using PrEP', 'babies with in-utero exposure to tenofovir-based preexposure prophylaxis for HIV prevention', '30 women who elected to continue PrEP throughout pregnancy']","['PrEP integrated with ART', 'placebo', 'preexposure prophylaxis (PrEP']","['preterm delivery', 'frequency of pregnancy loss', 'head circumference', 'congenital anomalies', 'pregnancy outcomes and 1-year infant growth']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]","[{'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0687675', 'cui_str': 'Pregnancy loss'}, {'cui': 'C0262499', 'cui_str': 'Head circumference (observable entity)'}, {'cui': 'C0000768', 'cui_str': 'Birth Defects'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]",,0.0809967,This first evaluation among women using PrEP throughout pregnancy indicates no greater frequency of adverse pregnancy outcomes or restricted infant growth; these findings support recommendations permitting PrEP use during pregnancy.,"[{'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Heffron', 'Affiliation': 'Department of Global Health.'}, {'ForeName': 'Nelly', 'Initials': 'N', 'LastName': 'Mugo', 'Affiliation': 'Department of Global Health.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Hong', 'Affiliation': 'Department of Global Health.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Celum', 'Affiliation': 'Department of Global Health.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Marzinke', 'Affiliation': 'Department of Pathology.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Ngure', 'Affiliation': 'Department of Global Health.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Asiimwe', 'Affiliation': 'Kabwohe Clinical Research Center.'}, {'ForeName': 'Elly', 'Initials': 'E', 'LastName': 'Katabira', 'Affiliation': 'Infectious Disease Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Bukusi', 'Affiliation': 'Department of Global Health.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Odoyo', 'Affiliation': 'Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Edna', 'Initials': 'E', 'LastName': 'Tindimwebwa', 'Affiliation': 'Kabwohe Clinical Research Center.'}, {'ForeName': 'Nulu', 'Initials': 'N', 'LastName': 'Bulya', 'Affiliation': 'Infectious Disease Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Department of Global Health.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","AIDS (London, England)",['10.1097/QAD.0000000000001867']
1546,29871789,Discrimination of nicotine content in electronic cigarettes.,"INTRODUCTION


Behavioral discrimination of nicotine has only recently been assessed in humans, administered mostly by nasal spray before the newly available Spectrum research cigarettes differing in nicotine content. Here we wanted to explore applicability of these procedures to assess discrimination of nicotine administered by e-cigarettes.
METHODS


In this feasibility study, 16 adult smokers were tested on ability to discriminate e-cigarettes with nicotine concentrations of 36, 24, and 12 mg/ml, one per session (in that order), from a placebo (0 mg/ml), each identified only by letter code. Reliable discrimination was defined by accurately identifying which was which (i.e. nicotine vs placebo) on >85% of trials (i.e. ≥7 of 8; p < .05). Subjective perceptions were also assessed.
RESULTS


Discrimination from placebo was shown with 36 mg/ml and with 24 mg/ml nicotine in 15 of 16 subjects, but only 10 discriminated placebo from 12 mg/ml nicotine. Subjective items previously related to acute nicotine exposure (""how much nicotine"", ""head rush/buzzed"" on 0-100 VAS) generally showed nicotine concentration-dependent effects, as expected, but so did ""throat irritation"".
CONCLUSIONS


Preliminary results confirm feasibility of using our behavioral procedure to assess ability to discriminate nicotine administered via these e-cigarettes, broadening generalizability of this procedure beyond nicotine via nasal spray and smoked tobacco cigarettes. Findings also suggest its applicability with testing discrimination of nicotine via other methods of rapid dosing (e.g., hookah, novel products), including the newer e-cigarette products. Further study with larger samples may identify individual difference and other factors influencing nicotine discrimination administered via e-cigarettes and other products.",2019,"RESULTS


Discrimination from placebo was shown with 36 mg/ml and with 24 mg/ml nicotine in 15 of 16 subjects, but only 10 discriminated placebo from 12 mg/ml nicotine.","['electronic cigarettes', '16 adult smokers']","['nicotine vs placebo', 'nicotine administered by e-cigarettes', 'ml nicotine', 'placebo']",['Subjective perceptions'],"[{'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",16.0,0.0968073,"RESULTS


Discrimination from placebo was shown with 36 mg/ml and with 24 mg/ml nicotine in 15 of 16 subjects, but only 10 discriminated placebo from 12 mg/ml nicotine.","[{'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Perkins', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA. Electronic address: perkinska@upmc.edu.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Herb', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Joshua L', 'Initials': 'JL', 'LastName': 'Karelitz', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}]",Addictive behaviors,['10.1016/j.addbeh.2018.05.027']
1547,26575060,Early Administration of Azithromycin and Prevention of Severe Lower Respiratory Tract Illnesses in Preschool Children With a History of Such Illnesses: A Randomized Clinical Trial.,"IMPORTANCE


Many preschool children develop recurrent, severe episodes of lower respiratory tract illness (LRTI). Although viral infections are often present, bacteria may also contribute to illness pathogenesis. Strategies that effectively attenuate such episodes are needed.
OBJECTIVE


To evaluate if early administration of azithromycin, started prior to the onset of severe LRTI symptoms, in preschool children with recurrent severe LRTIs can prevent the progression of these episodes.
DESIGN, SETTING, AND PARTICIPANTS


A randomized, double-blind, placebo-controlled, parallel-group trial conducted across 9 academic US medical centers in the National Heart, Lung, and Blood Institute's AsthmaNet network, with enrollment starting in April 2011 and follow-up complete by December 2014. Participants were 607 children aged 12 through 71 months with histories of recurrent, severe LRTIs and minimal day-to-day impairment.
INTERVENTION


Participants were randomly assigned to receive azithromycin (12 mg/kg/d for 5 days; n = 307) or matching placebo (n = 300), started early during each predefined RTI (child's signs or symptoms prior to development of LRTI), based on individualized action plans, over a 12- through 18-month period.
MAIN OUTCOMES AND MEASURES


The primary outcome measure was the number of RTIs not progressing to a severe LRTI, measured at the level of the RTI, that would in clinical practice trigger the prescription of oral corticosteroids. Presence of azithromycin-resistant organisms in oropharyngeal samples, along with adverse events, were among the secondary outcome measures.
RESULTS


A total of 937 treated RTIs (azithromycin group, 473; placebo group, 464) were experienced by 443 children (azithromycin group, 223; placebo group, 220), including 92 severe LRTIs (azithromycin group, 35; placebo group, 57). Azithromycin significantly reduced the risk of progressing to severe LRTI relative to placebo (hazard ratio, 0.64 [95% CI, 0.41-0.98], P = .04; absolute risk for first RTI: 0.05 for azithromycin, 0.08 for placebo; risk difference, 0.03 [95% CI, 0.00-0.06]). Induction of azithromycin-resistant organisms and adverse events were infrequently observed.
CONCLUSIONS AND RELEVANCE


Among young children with histories of recurrent severe LRTIs, the use of azithromycin early during an apparent RTI compared with placebo reduced the likelihood of severe LRTI. More information is needed on the development of antibiotic-resistant pathogens with this strategy.
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT01272635.",2015,"Azithromycin significantly reduced the risk of progressing to severe LRTI relative to placebo (hazard ratio, 0.64","[""9 academic US medical centers in the National Heart, Lung, and Blood Institute's AsthmaNet network, with enrollment starting in April 2011 and follow-up complete by December 2014"", 'preschool children develop recurrent, severe episodes of lower respiratory tract illness (LRTI', 'preschool children with recurrent severe LRTIs', 'Preschool Children With a History of Such Illnesses', 'Participants were 607 children aged 12 through 71 months with histories of recurrent, severe LRTIs and minimal day-to-day impairment', 'group, 473; placebo group, 464) were experienced by 443 children (azithromycin group, 223; placebo group, 220), including 92 severe LRTIs (azithromycin group, 35; placebo group, 57', 'young children with histories of recurrent severe LRTIs']","['matching placebo', 'placebo', 'azithromycin', 'Azithromycin', 'RTIs (azithromycin']","['likelihood of severe LRTI', 'number of RTIs not progressing to a severe LRTI, measured at the level of the RTI, that would in clinical practice trigger the prescription of oral corticosteroids', 'adverse events', 'risk of progressing to severe LRTI']","[{'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C1955970', 'cui_str': 'National Heart, Lung, and Blood Institute'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0282335', 'cui_str': 'Respiratory Tract'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection (disorder)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}]","[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection (disorder)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",607.0,0.566444,"Azithromycin significantly reduced the risk of progressing to severe LRTI relative to placebo (hazard ratio, 0.64","[{'ForeName': 'Leonard B', 'Initials': 'LB', 'LastName': 'Bacharier', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}, {'ForeName': 'Theresa W', 'Initials': 'TW', 'LastName': 'Guilbert', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Mauger', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Boehmer', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}, {'ForeName': 'Avraham', 'Initials': 'A', 'LastName': 'Beigelman', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Fitzpatrick', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Jackson', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}, {'ForeName': 'Sachin N', 'Initials': 'SN', 'LastName': 'Baxi', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}, {'ForeName': 'Mindy', 'Initials': 'M', 'LastName': 'Benson', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}, {'ForeName': 'Carey-Ann D', 'Initials': 'CD', 'LastName': 'Burnham', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cabana', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Chmiel', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}, {'ForeName': 'Ronina', 'Initials': 'R', 'LastName': 'Covar', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Daines', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Gaffin', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}, {'ForeName': 'Deborah Ann', 'Initials': 'DA', 'LastName': 'Gentile', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Holguin', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Israel', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}, {'ForeName': 'H William', 'Initials': 'HW', 'LastName': 'Kelly', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Lazarus', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Lemanske', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}, {'ForeName': 'Ngoc', 'Initials': 'N', 'LastName': 'Ly', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}, {'ForeName': 'Kelley', 'Initials': 'K', 'LastName': 'Meade', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Morgan', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Moy', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}, {'ForeName': 'Tod', 'Initials': 'T', 'LastName': 'Olin', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Peters', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Phipatanakul', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}, {'ForeName': 'Jacqueline A', 'Initials': 'JA', 'LastName': 'Pongracic', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}, {'ForeName': 'Hengameh H', 'Initials': 'HH', 'LastName': 'Raissy', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}, {'ForeName': 'Kristie', 'Initials': 'K', 'LastName': 'Ross', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sheehan', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Sorkness', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}, {'ForeName': 'Stanley J', 'Initials': 'SJ', 'LastName': 'Szefler', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}, {'ForeName': 'W Gerald', 'Initials': 'WG', 'LastName': 'Teague', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Thyne', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}, {'ForeName': 'Fernando D', 'Initials': 'FD', 'LastName': 'Martinez', 'Affiliation': ""Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, Missouri (Bacharier, Beigelman, Castro); Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio (Guilbert); Department of Public Health Sciences, Pennsylvania State University, Hershey (Mauger, Boehmer); Department of Pediatrics, Emory University, Atlanta, Georgia (Fitzpatrick); Pediatrics Section of Allergy, Immunology, and Rheumatology, University of Wisconsin School of Medicine and Public Health, Madison (Jackson); Division of Allergy/Immunology, Boston Children's Hospital, Boston, Massachusetts (Baxi, Phipatanakul, Sheehan); Benioff Children's Hospital, Oakland, California (Benson, Meade); Department of Pathology and Immunology, Washington University in St Louis School of Medicine, St Louis, Missouri (Burnham); University of California, San Francisco, Medicine, San Francisco (Cabana, Lazarus); Rainbow Babies and Children's Hospital, Cleveland, Ohio (Chmiel, Ross); Department of Pediatrics, National Jewish Health, Denver, Colorado (Covar, Olin); University of Arizona, Arizona Respiratory Center, Tucson (Daines, Morgan); Division of Respiratory Diseases, Boston Children's Hospital, Boston, Massachusetts (Gaffin); Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania (Gentile); The University of Pittsburgh Asthma Institute, Pittsburgh, Pennsylvania (Holguin); Brigham and Women's Hospital, Boston, Massachusetts (Israel); Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico (Kelly); Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (Lemanske); Airway Clinical Research Center, University of California, San Francisco, San Francisco, California (Ly); Stroger Hospital of Cook County Pediatric Services, Chicago, Illinois (Moy); Wake Forest University School of Medicine, Winston-Salem, North Carolina (Peters); Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois (Pongracic); Department of Pediatrics/Pulmonary, University of New Mexico, Albuquerque (Raissy); University of Wisconsin-Madison, Madison (Sorkness); The Breathing Institute, Children's Hospital Colorado, Denver (Szefler); University of Virginia School of Medicine, Charlottesville (Teague); Department of Pediatrics, San Francisco General Hospital, San Francisco, California (Thyne); Arizona Respiratory Center, University of Arizona, Tucson, Arizona (Martinez).""}]",JAMA,['10.1001/jama.2015.13896']
1548,29486867,Rostral Anterior Cingulate Cortex Morphology Predicts Treatment Response to Internet-Based Cognitive Behavioral Therapy for Depression.,"BACKGROUND


Rostral and subgenual anterior cingulate cortex (rACC and sgACC) activity and, to a lesser extent, volume have been shown to predict depressive symptom improvement across different antidepressant treatments. This study extends prior work by examining whether rACC and/or sgACC morphology predicts treatment response to Internet-based cognitive behavioral therapy (iCBT) for major depressive disorder. This is the first study to examine neural predictors of response to iCBT.
METHODS


Hierarchical linear modeling tested whether pretreatment rACC and sgACC volumes predicted depressive symptom improvement during a six-session (10-week) randomized clinical trial of iCBT (n = 35) versus a monitored attention control condition (n = 38). Analyses also tested whether pretreatment rACC and sgACC volumes differed between patients who achieved depression remission versus patients who did not remit.
RESULTS


Larger pretreatment right rACC volume was a significant predictor of greater depressive symptom improvement in iCBT even when controlling for demographic (age, gender, race) and clinical (baseline depression, anhedonia, and anxiety) variables previously linked to treatment response. In addition, pretreatment right rACC volume was larger among patients receiving iCBT whose depression eventually remitted relative to patients who did not remit. Corresponding analyses in the monitored attention control group and for the sgACC were not significant.
CONCLUSIONS


rACC volume before iCBT demonstrated incremental predictive validity beyond clinical and demographic variables previously found to predict symptom improvement. Such findings may help inform our understanding of the mediating anatomy of iCBT and, if replicated, may suggest neural targets to augment treatment response (e.g., via modulation of rACC function).",2018,"Analyses also tested whether pretreatment rACC and sgACC volumes differed between patients who achieved depression remission versus patients who did not remit.
",['major depressive disorder'],"['Internet-based cognitive behavioral therapy (iCBT', 'Internet-Based Cognitive Behavioral Therapy', 'rACC', 'iCBT', 'monitored attention control condition']",['pretreatment right rACC volume'],"[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",,0.0326936,"Analyses also tested whether pretreatment rACC and sgACC volumes differed between patients who achieved depression remission versus patients who did not remit.
","[{'ForeName': 'Christian A', 'Initials': 'CA', 'LastName': 'Webb', 'Affiliation': 'Center for Depression, Anxiety and Stress Research, McLean Hospital, Belmont, Massachusetts; Department of Psychiatry, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Olson', 'Affiliation': 'Center for Depression, Anxiety and Stress Research, McLean Hospital, Belmont, Massachusetts; Department of Psychiatry, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'William D S', 'Initials': 'WDS', 'LastName': 'Killgore', 'Affiliation': 'Department of Psychiatry, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Diego A', 'Initials': 'DA', 'LastName': 'Pizzagalli', 'Affiliation': 'Center for Depression, Anxiety and Stress Research, McLean Hospital, Belmont, Massachusetts; Department of Psychiatry, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Scott L', 'Initials': 'SL', 'LastName': 'Rauch', 'Affiliation': 'Center for Depression, Anxiety and Stress Research, McLean Hospital, Belmont, Massachusetts; Department of Psychiatry, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Isabelle M', 'Initials': 'IM', 'LastName': 'Rosso', 'Affiliation': 'Center for Depression, Anxiety and Stress Research, McLean Hospital, Belmont, Massachusetts; Department of Psychiatry, Harvard Medical School, Boston, Massachusetts. Electronic address: irosso@hms.harvard.edu.'}]",Biological psychiatry. Cognitive neuroscience and neuroimaging,['10.1016/j.bpsc.2017.08.005']
1549,31629649,"Serological response to three alternative series of hepatitis B revaccination (Fendrix, Twinrix, and HBVaxPro-40) in healthy non-responders: a multicentre, open-label, randomised, controlled, superiority trial.","BACKGROUND


Serological non-response can be present after hepatitis B vaccination in healthy adults. We aimed to establish which of three revaccination regimens is most effective at inducing protective immunity METHODS: Healthy adults (aged 18-80 years) from 16 Dutch centres (13 public health services, two university hospitals, and one travel clinic) were included in this multicentre, parallel group, randomised, controlled, superiority trial. The inclusion criterion was vaccine non-response (hepatitis B surface antibody [anti-HBs] titre <10 IU/L) after a primary series with three doses of one type of recombinant vaccine against hepatitis B virus (either HBVaxPro-10 or Engerix-B at months 0, 1, and 6). Participants were individually randomly assigned (1:1:1:1) to a vaccination series of repeated initial vaccination (HBVaxPro 10 μg or Engerix-B 20 μg) as the control, or to Twinrix 20 μg, Fendrix 20 μg, or HBVaxPro 40 μg. We used a web-based randomisation programme, stratified by centre, with a block size of four. Participants and centres were unmasked to assignment after randomisation. Laboratory staff and investigators were masked to vaccine-group assignment. All revaccination schedules were identical, with intramuscular vaccinations at 0, 1, and 2 months. Anti-HBs was measured at 0, 1, 2, and 3 months. The primary outcome was the percentage of responders (anti-HBs titres ≥10 IU/L) at 3 months. Immunogenicity and safety analyses were based on an intention-to-vaccinate analysis, the immunogenicity analysis with last observation carried forward for missing data, and the Bonferroni and the Benjamini-Hochberg method were applied to correct for multiple testing. The trial was registered in the Dutch National Trial Register and inclusion has been stopped (identifier NL3011; EudraCT-number 2011-005627-40).
FINDINGS


The participants were recruited between Nov 1, 2012, and Sept 1, 2017. 480 participants were randomly assigned and included in intention-to-vaccinate analyses: 124 (26%) to control, 118 (25%) to Twinrix, 114 (24%) to HBVaxPro-40, and 124 (26%) to Fendrix. At month 3 the percentage of responders was 83 (67%) of 124 (95% CI 57·9-75·1 in the control group, 94 (80%) of the 118 (71·3-86·5) in the Twinrix group, 95 (83%) of 114 (75·2-89·7) in the HBVaxPro-40 group, and 108 (87%) of 124 (79·9-92·4) in the Fendrix group. Compared with the control group, the percentage of responders was superior for the HBVaxPro-40 group (adjusted difference 21·6% [95% CI 10·4-32·7], p=0·0204 [Bonferroni corrected p value]) and the Fendrix group (26·3% [15·4-37·3], p=0·0006), but not the Twinrix group (25·0% [13·0-37·0]; p=0·0846). One serious adverse event occurred (herpes zoster ophthalmicus) in the Fendrix group, which was not attributed to the vaccine.
INTERPRETATION


Revaccinating healthy non-responders with Fendrix or HBVaxPro-40 resulted in significantly higher proportions of responders and therefore indication for these vaccines should be expanded to enable revaccination of non-responders.
FUNDING


National Institute for Public Health and the Environment.",2020,"One serious adverse event occurred (herpes zoster ophthalmicus) in the Fendrix group, which was not attributed to the vaccine.
","['Healthy adults (aged 18-80 years) from 16 Dutch centres (13 public health services, two university hospitals, and one travel clinic', 'participants were recruited between Nov 1, 2012, and Sept 1, 2017', '480 participants', 'healthy adults', 'healthy non-responders']","['HBVaxPro-40', 'hepatitis B revaccination (Fendrix, Twinrix, and HBVaxPro-40', 'vaccination series of repeated initial vaccination (HBVaxPro 10 μg or Engerix-B 20 μg) as the control, or to Twinrix 20 μg, Fendrix 20 μg, or HBVaxPro 40 μg', 'recombinant vaccine against hepatitis B virus (either HBVaxPro-10']","['Anti-HBs', 'Immunogenicity and safety analyses', 'percentage of responders (anti-HBs titres ≥10 IU/L']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0699943', 'cui_str': 'Public health service (qualifier value)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0040802', 'cui_str': 'Travel (event)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C4319609', 'cui_str': '480'}]","[{'cui': 'C0019163', 'cui_str': 'Hepatitis B Virus Infection'}, {'cui': 'C2713304', 'cui_str': 'Revaccination'}, {'cui': 'C1872587', 'cui_str': 'Fendrix'}, {'cui': 'C0593953', 'cui_str': 'Twinrix'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0205549', 'cui_str': 'Series (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0116078', 'cui_str': 'Engerix-B'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0034862', 'cui_str': 'Vaccines, Recombinant'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}]","[{'cui': 'C0369334', 'cui_str': 'Antibody to hepatitis B surface antigen (substance)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0439457', 'cui_str': 'milliinternational unit/milliliter'}]",480.0,0.286597,"One serious adverse event occurred (herpes zoster ophthalmicus) in the Fendrix group, which was not attributed to the vaccine.
","[{'ForeName': 'Stijn F H', 'Initials': 'SFH', 'LastName': 'Raven', 'Affiliation': 'Department of Infectious Diseases, Regional Public Health Service West Brabant, Breda, Netherlands; Department of Medical Microbiology, Care and Public Health Research Institute (CAPHRI), Maastricht University Medical Centre, Maastricht, Netherlands. Electronic address: stijn.raven@radboudumc.nl.'}, {'ForeName': 'Christian J P A', 'Initials': 'CJPA', 'LastName': 'Hoebe', 'Affiliation': 'Department of Medical Microbiology, Care and Public Health Research Institute (CAPHRI), Maastricht University Medical Centre, Maastricht, Netherlands; Department of Sexual Health, Infectious Diseases and Environmental Health, South Limburg Public Health Service, Netherlands.'}, {'ForeName': 'Ann C T M', 'Initials': 'ACTM', 'LastName': 'Vossen', 'Affiliation': 'Department of Medical Microbiology, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Leo G', 'Initials': 'LG', 'LastName': 'Visser', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Jeannine L A', 'Initials': 'JLA', 'LastName': 'Hautvast', 'Affiliation': 'Department of Primary and Community Care, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Anna H E', 'Initials': 'AHE', 'LastName': 'Roukens', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Jim E', 'Initials': 'JE', 'LastName': 'van Steenbergen', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Centre, Leiden, Netherlands; Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, Netherlands.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30417-7']
1550,31630089,Cognitive functional therapy compared with a group-based exercise and education intervention for chronic low back pain: a multicentre randomised controlled trial (RCT).,"BACKGROUND


One-size-fits-all interventions reduce chronic low back pain (CLBP) a small amount. An individualised intervention called cognitive functional therapy (CFT) was superior for CLBP compared with manual therapy and exercise in one randomised controlled trial (RCT). However, systematic reviews show group interventions are as effective as one-to-one interventions for musculoskeletal pain. This RCT investigated whether a physiotherapist-delivered individualised intervention (CFT) was more effective than physiotherapist-delivered group-based exercise and education for individuals with CLBP.
METHODS


206 adults with CLBP were randomised to either CFT (n=106) or group-based exercise and education (n=100). The length of the CFT intervention varied according to the clinical progression of participants (mean=5 treatments). The group intervention consisted of up to 6 classes (mean=4 classes) over 6-8 weeks. Primary outcomes were disability and pain intensity in the past week at 6 months and 12months postrandomisation. Analysis was by intention-to-treat using linear mixed models.
RESULTS


CFT reduced disability more than the group intervention at 6 months (mean difference, 8.65; 95% CI 3.66 to 13.64; p=0.001), and at 12 months (mean difference, 7.02; 95% CI 2.24 to 11.80; p=0.004). There were no between-group differences observed in pain intensity at 6 months (mean difference, 0.76; 95% CI -0.02 to 1.54; p=0.056) or 12 months (mean difference, 0.65; 95% CI -0.20 to 1.50; p=0.134).
CONCLUSION


CFT reduced disability, but not pain, at 6 and 12 months compared with the group-based exercise and education intervention. Future research should examine whether the greater reduction in disability achieved by CFT renders worthwhile differences for health systems and patients.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov registry (NCT02145728).",2020,An individualised intervention called cognitive functional therapy (CFT) was superior for CLBP compared with manual therapy and exercise in one randomised controlled trial (RCT).,"['206 adults with CLBP', 'chronic low back pain']","['Cognitive functional therapy compared with a group-based exercise and education intervention', 'CFT', 'physiotherapist-delivered individualised intervention (CFT', 'physiotherapist-delivered group-based exercise and education', 'individualised intervention called cognitive functional therapy (CFT', 'CFT (n=106) or group-based exercise and education']","['pain intensity', 'disability and pain intensity', 'disability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",206.0,0.198245,An individualised intervention called cognitive functional therapy (CFT) was superior for CLBP compared with manual therapy and exercise in one randomised controlled trial (RCT).,"[{'ForeName': 'Mary', 'Initials': 'M', 'LastName': ""O'Keeffe"", 'Affiliation': 'Institute for Musculoskeletal Health, Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia mary.okeeffe@sydney.edu.au.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': ""O'Sullivan"", 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Shenton Park, Perth, Western Australia, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Purtill', 'Affiliation': 'Department of Mathematics & Statistics, Faculty of Science & Engineering, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'Norma', 'Initials': 'N', 'LastName': 'Bargary', 'Affiliation': 'Department of Mathematics & Statistics, Faculty of Science & Engineering, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': ""O'Sullivan"", 'Affiliation': 'Health Research Institute, University of Limerick, Limerick, Ireland.'}]",British journal of sports medicine,['10.1136/bjsports-2019-100780']
1551,31630990,"Immunogenicity of chimeric haemagglutinin-based, universal influenza virus vaccine candidates: interim results of a randomised, placebo-controlled, phase 1 clinical trial.","BACKGROUND


Influenza viruses cause substantial annual morbidity and mortality globally. Current vaccines protect against influenza only when well matched to the circulating strains. However, antigenic drift can cause considerable mismatches between vaccine and circulating strains, substantially reducing vaccine effectiveness. Moreover, current seasonal vaccines are ineffective against pandemic influenza, and production of a vaccine matched to a newly emerging virus strain takes months. Therefore, there is an unmet medical need for a broadly protective influenza virus vaccine. We aimed to test the ability of chimeric H1 haemagglutinin-based universal influenza virus vaccine candidates to induce broadly cross-reactive antibodies targeting the stalk domain of group 1 haemagglutinin-expressing influenza viruses.
METHODS


We did a randomised, observer-blinded, phase 1 study in healthy adults in two centres in the USA. Participants were randomly assigned to one of three prime-boost, chimeric haemagglutinin-based vaccine regimens or one of two placebo groups. The vaccine regimens included a chimeric H8/1, intranasal, live-attenuated vaccine on day 1 followed by a non-adjuvanted, chimeric H5/1, intramuscular, inactivated vaccine on day 85; the same regimen but with the inactivated vaccine being adjuvanted with AS03; and an AS03-adjuvanted, chimeric H8/1, intramuscular, inactivated vaccine followed by an AS03-adjuvanted, chimeric H5/1, intramuscular, inactivated vaccine. In this planned interim analysis, the primary endpoints of reactogenicity and safety were assessed by blinded study group. We also assessed anti-H1 haemagglutinin stalk, anti-H2, anti-H9, and anti-H18 IgG antibody titres and plasmablast and memory B-cell responses in peripheral blood. This trial is registered with ClinicalTrials.gov, number NCT03300050.
FINDINGS


Between Oct 10, 2017, and Nov 27, 2017, 65 participants were enrolled and randomly assigned. The adjuvanted inactivated vaccine, but not the live-attenuated vaccine, induced a substantial serum IgG antibody response after the prime immunisation, with a seven times increase in anti-H1 stalk antibody titres on day 29. After boost immunisation, all vaccine regimens induced detectable anti-H1 stalk antibody (2·2-5·6 times induction over baseline), cross-reactive serum IgG antibody, and peripheral blood plasmablast responses. An unsolicited adverse event was reported for 29 (48%) of 61 participants. Solicited local adverse events were reported in 12 (48%) of 25 participants following prime vaccination with intramuscular study product or placebo, in 12 (33%) of 36 after prime immunisation with intranasal study product or placebo, and in 18 (32%) of 56 following booster doses of study product or placebo. Solicited systemic adverse events were reported in 14 (56%) of 25 after prime immunisation with intramuscular study product or placebo, in 22 (61%) of 36 after immunisation with intranasal study product or placebo, and in 21 (38%) of 56 after booster doses of study product or placebo. Disaggregated safety data were not available at the time of this interim analysis.
INTERPRETATION


The tested chimeric haemagglutinin-based, universal influenza virus vaccine regimens elicited cross-reactive serum IgG antibodies that targeted the conserved haemagglutinin stalk domain. This is the first proof-of-principle study to show that high anti-stalk titres can be induced by a rationally designed vaccine in humans and opens up avenues for further development of universal influenza virus vaccines. On the basis of the blinded study group, the vaccine regimens were tolerable and no safety concerns were observed.
FUNDING


Bill & Melinda Gates Foundation.",2020,"Solicited local adverse events were reported in 12 (48%) of 25 participants following prime vaccination with intramuscular study product or placebo, in 12 (33%) of 36 after prime immunisation with intranasal study product or placebo, and in 18 (32%) of 56 following booster doses of study product or placebo.","['healthy adults in two centres in the USA', 'peripheral blood', 'Between Oct 10, 2017, and Nov 27, 2017, 65 participants were enrolled and randomly assigned']","['placebo', 'chimeric haemagglutinin-based vaccine regimens or one of two placebo', 'chimeric H8/1, intranasal, live-attenuated vaccine', 'inactivated vaccine being adjuvanted with AS03; and an AS03-adjuvanted, chimeric H8/1, intramuscular, inactivated vaccine followed by an AS03-adjuvanted, chimeric H5/1, intramuscular, inactivated vaccine']","['Solicited systemic adverse events', 'detectable anti-H1 stalk antibody (2·2-5·6 times induction over baseline), cross-reactive serum IgG antibody, and peripheral blood plasmablast responses', 'tolerable and no safety concerns', 'anti-H1 stalk antibody titres', 'reactogenicity and safety', 'anti-H1 haemagglutinin stalk, anti-H2, anti-H9, and anti-H18 IgG antibody titres and plasmablast and memory B-cell responses', 'vaccine effectiveness', 'Solicited local adverse events', 'substantial serum IgG antibody response']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0935572', 'cui_str': 'Stalkings'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0229657', 'cui_str': 'Plasmablast (cell)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}]",65.0,0.338098,"Solicited local adverse events were reported in 12 (48%) of 25 participants following prime vaccination with intramuscular study product or placebo, in 12 (33%) of 36 after prime immunisation with intranasal study product or placebo, and in 18 (32%) of 56 following booster doses of study product or placebo.","[{'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Bernstein', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA; Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Guptill', 'Affiliation': 'Duke Early Phase Clinical Research Unit, Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Abdollah', 'Initials': 'A', 'LastName': 'Naficy', 'Affiliation': 'Center for Vaccine Innovation and Access, PATH, Seattle, WA, USA.'}, {'ForeName': 'Raffael', 'Initials': 'R', 'LastName': 'Nachbagauer', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Berlanda-Scorza', 'Affiliation': 'Center for Vaccine Innovation and Access, PATH, Seattle, WA, USA.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Feser', 'Affiliation': 'Center for Vaccine Innovation and Access, PATH, Seattle, WA, USA.'}, {'ForeName': 'Patrick C', 'Initials': 'PC', 'LastName': 'Wilson', 'Affiliation': 'Section of Rheumatology, Department of Medicine, University of Chicago, Chicago, IL, USA; The Committee on Immunology, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Solórzano', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Van der Wielen', 'Affiliation': 'GlaxoSmithKline, Wavre, Belgium.'}, {'ForeName': 'Emmanuel B', 'Initials': 'EB', 'LastName': 'Walter', 'Affiliation': 'Duke Early Phase Clinical Research Unit, Duke Clinical Research Institute, Durham, NC, USA; Duke Human Vaccine Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Randy A', 'Initials': 'RA', 'LastName': 'Albrecht', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Global Health and Emerging Pathogens Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Kristen N', 'Initials': 'KN', 'LastName': 'Buschle', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA; Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Yao-Qing', 'Initials': 'YQ', 'LastName': 'Chen', 'Affiliation': 'Section of Rheumatology, Department of Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Claeys', 'Affiliation': 'GlaxoSmithKline, Wavre, Belgium.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Dickey', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA; Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Haley L', 'Initials': 'HL', 'LastName': 'Dugan', 'Affiliation': 'The Committee on Immunology, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Ermler', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA; GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Freeman', 'Affiliation': 'Duke Early Phase Clinical Research Unit, Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Gao', 'Affiliation': 'Duke Early Phase Clinical Research Unit, Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Gast', 'Affiliation': 'Center for Vaccine Innovation and Access, PATH, Seattle, WA, USA.'}, {'ForeName': 'Jenna J', 'Initials': 'JJ', 'LastName': 'Guthmiller', 'Affiliation': 'Section of Rheumatology, Department of Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Hai', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Department of Microbiology and Plant Pathology, Institute for Integrative Genome Biology, University of California, Riverside, CA, USA.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Henry', 'Affiliation': 'Section of Rheumatology, Department of Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Linda Yu-Ling', 'Initials': 'LY', 'LastName': 'Lan', 'Affiliation': 'The Committee on Immunology, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'McNeal', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA; Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Anna-Karin E', 'Initials': 'AE', 'LastName': 'Palm', 'Affiliation': 'Section of Rheumatology, Department of Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Dustin G', 'Initials': 'DG', 'LastName': 'Shaw', 'Affiliation': 'The Committee on Immunology, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Stamper', 'Affiliation': 'The Committee on Immunology, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Weina', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Sutton', 'Affiliation': 'Duke Early Phase Clinical Research Unit, Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Micah E', 'Initials': 'ME', 'LastName': 'Tepora', 'Affiliation': 'Section of Rheumatology, Department of Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Rahnuma', 'Initials': 'R', 'LastName': 'Wahid', 'Affiliation': 'Center for Vaccine Innovation and Access, PATH, Seattle, WA, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Wenzel', 'Affiliation': 'Center for Vaccine Innovation and Access, PATH, Seattle, WA, USA.'}, {'ForeName': 'Teddy John', 'Initials': 'TJ', 'LastName': 'Wohlbold', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Bruce L', 'Initials': 'BL', 'LastName': 'Innis', 'Affiliation': 'Center for Vaccine Innovation and Access, PATH, Seattle, WA, USA.'}, {'ForeName': 'Adolfo', 'Initials': 'A', 'LastName': 'García-Sastre', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Global Health and Emerging Pathogens Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Palese', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Krammer', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA. Electronic address: florian.krammer@mssm.edu.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30393-7']
1552,24990615,Mitochondrial priming of chronic lymphocytic leukemia patients associates Bcl-xL dependence with alvocidib response.,,2014,,['chronic lymphocytic leukemia patients'],[],[],"[{'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],[],,0.0210906,,"[{'ForeName': 'W E', 'Initials': 'WE', 'LastName': 'Pierceall', 'Affiliation': 'Eutropics Inc., Cambridge, MA, USA.'}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Warner', 'Affiliation': 'Tolero Pharmaceuticals, Inc., Lehi, UT, USA.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Lena', 'Affiliation': 'Eutropics Inc., Cambridge, MA, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Doykan', 'Affiliation': 'Eutropics Inc., Cambridge, MA, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Blake', 'Affiliation': 'Eutropics Inc., Cambridge, MA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Elashoff', 'Affiliation': 'Eutropics Inc., Cambridge, MA, USA.'}, {'ForeName': 'D V', 'Initials': 'DV', 'LastName': 'Hoff', 'Affiliation': '1] Tolero Pharmaceuticals, Inc., Lehi, UT, USA [2] Translational Genomics Research Institute, Scottsdale, AZ, USA.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Bearss', 'Affiliation': 'Tolero Pharmaceuticals, Inc., Lehi, UT, USA.'}, {'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Cardone', 'Affiliation': 'Eutropics Inc., Cambridge, MA, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Andritsos', 'Affiliation': 'Department of Internal Medicine, Division of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, OH, USA.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Byrd', 'Affiliation': 'Department of Internal Medicine, Division of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, OH, USA.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Lanasa', 'Affiliation': 'Department of Medicine, Duke Cancer Institute, Durham, NC, USA.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Grever', 'Affiliation': 'Department of Internal Medicine, Division of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, OH, USA.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Johnson', 'Affiliation': 'Department of Internal Medicine, Division of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, OH, USA.'}]",Leukemia,['10.1038/leu.2014.206']
1553,24172697,"Dessert formulation using sucralose and dextrin affects favorably postprandial response to glucose, insulin, and C-peptide in type 2 diabetic patients.","BACKGROUND


Dessert compositions may conform to diabetic diet when it contains low sugar or artificial sweetener to replace sugar. However, it is still questionable whether glycemic control in type 2 diabetes patients is improved by the use of diet-conforming dessert compositions.
OBJECTIVE


To compare, in type 2 diabetes patients, the glycemic, insulin, and C-peptide responses to seven modified dessert compositions for diabetics (D-dessert) with the response to seven similar desserts of non-modified composition, used as control desserts (C-dessert).
METHODS


Seventy type 2 diabetes patients were allocated to seven groups of ten. On three occasions, each patient received either the meal which consisted of bread and cheese, or the meal and D-dessert, or the meal and the respective C-dessert. Differences in postprandial glucose, insulin, and C-peptide were evaluated using analysis of repeated measures at 0, 30, 60, 90, and 120 min after consumption.
RESULTS


D-cake and D-pastry cream resulted in lower glucose levels (8.81 ± 0.32 mmol/l and 8.67 ± 0.36 mmol/l, respectively) and D-strawberry jelly in lower insulin levels (16.46 ± 2.66 μU/ml) than the respective C-desserts (9.99 ± 0.32 mmol/l for C-cake, 9.28 ± 0.36 mmol/l for C-pastry cream, and 27.42 ± 2.66 μU/ml for C-strawberry jelly) (p < 0.05). Compared with the meal, D-cake did not increase glucose or insulin levels (p < 0.05), while C-cake did (p < 0.05). D-pastry cream increased glucose to a lesser extent than C-pastry cream (p < 0.05). Similar effects were reported for D-milk dessert, D-millefeuille, and D-chocolate on glucose, insulin, and C-peptide at specific timepoints. D-crème caramel showed no effect.
CONCLUSIONS


Some desserts formulated with sugar substitutes and soluble fiber may have a favorable effect on postprandial levels of glucose, insulin, and C-peptide in type 2 diabetic patients.",2013,"Compared with the meal, D-cake did not increase glucose or insulin levels (p < 0.05), while C-cake did (p < 0.05).","['type 2 diabetic patients', 'Seventy type 2 diabetes patients', 'type 2 diabetes patients', 'type 2 diabetes patients, the glycemic, insulin, and C-peptide responses to seven modified dessert compositions for diabetics (D-dessert) with the response to seven similar desserts of non-modified composition, used as control desserts (C-dessert']",['sucralose and dextrin'],"['D-milk dessert, D-millefeuille, and D-chocolate on glucose, insulin, and C-peptide at specific timepoints', 'postprandial response to glucose, insulin, and C-peptide', 'postprandial levels of glucose, insulin, and C-peptide', 'lower glucose levels', 'postprandial glucose, insulin, and C-peptide', 'glucose or insulin levels']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0453505', 'cui_str': 'Dessert'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0077046', 'cui_str': 'sucralose'}, {'cui': 'C0054527', 'cui_str': 'caloreen'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0453505', 'cui_str': 'Dessert'}, {'cui': 'C0008299', 'cui_str': 'Chocolate'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}]",,0.0193765,"Compared with the meal, D-cake did not increase glucose or insulin levels (p < 0.05), while C-cake did (p < 0.05).","[{'ForeName': 'Konstantina', 'Initials': 'K', 'LastName': 'Argyri', 'Affiliation': 'Unit of Human Nutrition, Department of Food Science and Technology, Agricultural University of Athens, Iera Odos Str. 75, Athens 118 55, Greece.'}, {'ForeName': 'Alexios', 'Initials': 'A', 'LastName': 'Sotiropoulos', 'Affiliation': ''}, {'ForeName': 'Eirini', 'Initials': 'E', 'LastName': 'Psarou', 'Affiliation': ''}, {'ForeName': 'Athanasia', 'Initials': 'A', 'LastName': 'Papazafiropoulou', 'Affiliation': ''}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Zampelas', 'Affiliation': ''}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kapsokefalou', 'Affiliation': ''}]",The review of diabetic studies : RDS,['10.1900/RDS.2013.10.39']
1554,17491670,"""Low dose"" metformin improves hyperglycemia better than acarbose in type 2 diabetics.","OBJECTIVES


""High dose"" metformin therapy (2,550 mg/day) is reported to improve glycemic control in type 2 diabetic patients with obesity (body mass index (BMI) > or = 30). Some have reported that metformin therapy, even in low doses (500-750 mg/day), improves glycemic control in non-obese type 2 diabetic patients (BMI approximately 25). However, it is unclear whether ""low dose"" metformin improves glycemic control better than acarbose in non-obese type 2 diabetic patients, which has been shown to improve glycemic control in type 2 diabetes with obesity.
METHODS


We randomly divided 22 non-obese type 2 diabetic patients (mean BMI approximately 25) into two groups (A = 11, B = 11). Group A was treated with ""low dose"" metformin (500-750 mg/day) for 3 months, and switched to acarbose (150-300 mg/day) for another 3 months. Group B was treated with acarbose first, and then switched to ""low dose"" metformin.
RESULTS


""Low dose"" metformin significantly decreased the fasting plasma glucose (FPG) and HbA1c level in both groups A and B, whereas acarbose decreased HbA1c levels in group B but not in group A. Overall, ""low dose"" metformin significantly decreased HbA1c (p=0.0165) levels as compared to acarbose.
CONCLUSION


In conclusion, ""low dose"" metformin therapy improved glycemic control better than acarbose in non-obese diabetics.",2004,"RESULTS


""Low dose"" metformin significantly decreased the fasting plasma glucose (FPG) and HbA1c level in both groups A and B, whereas acarbose decreased HbA1c levels in group B but not in group A. Overall, ""low dose"" metformin significantly decreased HbA1c (p=0.0165) levels as compared to acarbose.
","['non-obese type 2 diabetic patients', 'type 2 diabetic patients with obesity (body mass index (BMI) > or = 30', 'randomly divided 22 non-obese type 2 diabetic patients (mean BMI approximately 25) into two groups (A = 11, B = 11', 'type 2 diabetics']","['low dose"" metformin therapy', ' metformin therapy', 'acarbose', 'low dose"" metformin', 'Low dose"" metformin', ' metformin']","['glycemic control better', 'HbA1c levels', 'glycemic control', 'hyperglycemia better', 'fasting plasma glucose (FPG) and HbA1c level']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0050393', 'cui_str': 'Acarbose'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}]",,0.0157022,"RESULTS


""Low dose"" metformin significantly decreased the fasting plasma glucose (FPG) and HbA1c level in both groups A and B, whereas acarbose decreased HbA1c levels in group B but not in group A. Overall, ""low dose"" metformin significantly decreased HbA1c (p=0.0165) levels as compared to acarbose.
","[{'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Yajima', 'Affiliation': 'Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Shimada', 'Affiliation': ''}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Hirose', 'Affiliation': ''}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Kasuga', 'Affiliation': ''}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Saruta', 'Affiliation': ''}]",The review of diabetic studies : RDS,[]
1555,17491696,"The relationship between dietary habits, blood glucose and insulin levels among people without cardiovascular disease and type 2 diabetes; the ATTICA study.","BACKGROUND


Diet has long been associated with a risk of insulin resistance and poor glycemic control. We sought to investigate the association between food groups and indices of glycemic control in adults without type 2 diabetes and cardiovascular disease.
METHODS


During 2001 - 2002 we randomly enrolled 1514 men (18-87 years old) and 1528 women (18-89 years old) without evidence of cardiovascular disease from the Attica area of Greece. Of them, 118 men and 92 women were excluded from the present analysis due to a history of diabetes mellitus (type 2). Fasting blood glucose and insulin levels were measured, while dietary habits were evaluated through a semi-quantitative food frequency questionnaire.
RESULTS


Red meat consumption was positively associated with hyperglycemia (p = 0.04), hyperinsulinemia (p = 0.04), and HOMA levels (p = 0.03), even after adjusting for BMI and various other potential confounders. The intake of fruits, vegetables, legumes, yogurt and other dairy products was not associated with levels of glycemic control indices.
CONCLUSIONS


A higher consumption of red meat and its products may aggravate hyperinsulinemia and insulin resistance in non-diabetic people.",2005,"RESULTS


Red meat consumption was positively associated with hyperglycemia (p = 0.04), hyperinsulinemia (p = 0.04), and HOMA levels (p = 0.03), even after adjusting for BMI and various other potential confounders.","['people without cardiovascular disease and type 2 diabetes', 'adults without type 2 diabetes and cardiovascular disease', '118 men and 92 women were excluded from the present analysis due to a history of diabetes mellitus (type 2', 'During 2001 - 2002 we randomly enrolled 1514 men (18-87 years old) and 1528 women (18-89 years old) without evidence of cardiovascular disease from the Attica area of Greece', 'non-diabetic people']",[],"['hyperglycemia', 'hyperinsulinemia', 'Fasting blood glucose and insulin levels', 'dietary habits, blood glucose and insulin levels', 'HOMA levels']","[{'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0455488', 'cui_str': 'H/O: diabetes mellitus'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332288', 'cui_str': 'Without (attribute)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]",[],"[{'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinemia'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",1514.0,0.0273453,"RESULTS


Red meat consumption was positively associated with hyperglycemia (p = 0.04), hyperinsulinemia (p = 0.04), and HOMA levels (p = 0.03), even after adjusting for BMI and various other potential confounders.","[{'ForeName': 'Demosthenes B', 'Initials': 'DB', 'LastName': 'Panagiotakos', 'Affiliation': 'Department of Nutrition and Dietetics, Harokopio University, 46 Paleon Polemiston St., 166 74 Attica, Athens, Greece. d.b.panagiotakos@usa.net'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Tzima', 'Affiliation': ''}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Pitsavos', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Chrysohoou', 'Affiliation': ''}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Papakonstantinou', 'Affiliation': ''}, {'ForeName': 'Antonis', 'Initials': 'A', 'LastName': 'Zampelas', 'Affiliation': ''}, {'ForeName': 'Christodoulos', 'Initials': 'C', 'LastName': 'Stefanadis', 'Affiliation': ''}]",The review of diabetic studies : RDS,[]
1556,21409315,Effects of different protein sources on plasminogen inhibitor-1 and factor VII coagulant activity added to a fat-rich meal in type 2 diabetes.,"BACKGROUND


Exaggerated postprandial triglyceride concentration is believed to be atherogenic, and to influence the risk of thrombosis. Both elevated plasminogen inhibitor 1 (PAI-1) and increased factor VII coagulant activity (FVIIc) are potential important contributors to the increased risk of cardiovascular disease in type 2 diabetes.
AIM


We aimed to investigate the effect of adding four different protein types (i.e. casein, whey, cod, and gluten) to a fat-rich meal on postprandial responses of PAI-1 and FVIIc in type 2 diabetic patients.
METHODS


Twelve type 2 diabetic patients ingested four isocaloric test meals in random order. The test meals contained 100 g of butter and 45 g of carbohydrate in combination with 45 g of casein (Cas-meal), whey (Whe-meal), cod (Cod-meal), or gluten (Glu-meal), respectively. Plasma concentrations of PAI-1 and FVIIc were measured before meal, and at regular intervals for 8-h postprandially.
RESULTS


The postprandial PAI-1 concentration decreased significantly by 49% to 56% in response to the four test meals. There were no significant differences between the outcomes from the four test-meals. The FVIIc levels decreased by 8% to 11% after the meals. Again, we observed no significant differences in outcomes between the four protein-enriched meals.
CONCLUSIONS


The four proteins casein, whey, cod, and gluten, added to a fat-rich meal, all decreased the PAI-1 and FVIIc concentrations postprandially in type 2 diabetic subjects. However, postprandial levels of PAI-1 and FVIIc were not acutely influenced by the protein source.",2010,"Both elevated plasminogen inhibitor 1 (PAI-1) and increased factor VII coagulant activity (FVIIc) are potential important contributors to the increased risk of cardiovascular disease in type 2 diabetes.
","['type 2 diabetic subjects', 'type 2 diabetes', 'Twelve type', 'type 2 diabetic patients', '2 diabetic patients ingested four']","['protein types (i.e. casein, whey, cod, and gluten) to a fat-rich meal', 'isocaloric test meals', 'meals contained 100 g of butter and 45 g of carbohydrate in combination with 45 g of casein (Cas-meal), whey (Whe-meal), cod (Cod-meal), or gluten (Glu-meal']","['factor VII coagulant activity (FVIIc', 'PAI-1 and FVIIc concentrations', 'FVIIc levels', 'plasminogen inhibitor-1 and factor VII coagulant activity', 'postprandial levels of PAI-1 and FVIIc', 'Plasma concentrations of PAI-1 and FVIIc', 'postprandial PAI-1 concentration']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0452720', 'cui_str': 'Whey'}, {'cui': 'C0459207', 'cui_str': 'Cod'}, {'cui': 'C2362561', 'cui_str': 'Gluten'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0006494', 'cui_str': 'Butter'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0061055', 'cui_str': 'Glu-(Abu)'}]","[{'cui': 'C0060028', 'cui_str': 'FVII-C'}, {'cui': 'C0030190', 'cui_str': 'SERPINE1 Protein'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0032140', 'cui_str': 'Profibrinolysin'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}]",,0.0250889,"Both elevated plasminogen inhibitor 1 (PAI-1) and increased factor VII coagulant activity (FVIIc) are potential important contributors to the increased risk of cardiovascular disease in type 2 diabetes.
","[{'ForeName': 'Lene S', 'Initials': 'LS', 'LastName': 'Mortensen', 'Affiliation': 'Department of Endocrinology and Metabolism MEA, Aarhus University Hospital, Tage-Hansens Gade 2, 8000 Aarhus C, Denmark. lene.sundahl@ki.au.dk'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Thomsen', 'Affiliation': ''}, {'ForeName': 'Kjeld', 'Initials': 'K', 'LastName': 'Hermansen', 'Affiliation': ''}]",The review of diabetic studies : RDS,['10.1900/RDS.2010.7.233']
1557,18795212,"Effect of zinc supplementation on microalbuminuria in patients with type 2 diabetes: a double blind, randomized, placebo-controlled, cross-over trial.","OBJECTIVES


Oxidative stress can contribute to microvascular complications in diabetes. A decisive event associated with this condition may be the decrease in the synthesis of zinc-containing antioxidant enzymes such as superoxide dismutase and glutathione peroxidase. This consideration led us to investigate the effect of zinc supplementation versus placebo on microalbuminuria in diabetic patients in a randomized double blind clinical trial.
METHODS


Fifty diabetic patients with microalbuminuria were enrolled. Fasting plasma glucose, HbA1c, lipid profiles, plasma zinc levels and random urine for albumin and creatinine were measured. Patients randomly received 30 mg elemental zinc (group 1) or placebo (group 2) for 3 months. After a 4 week wash-out period, the groups were crossed over (i.e. the zinc group were given placebo, and the placebo group were given zinc) and the protocol was repeated.
RESULTS


From an initial number of 50 selected patients (25 in each of two groups), 39 patients (21 in group 1 and 18 in group 2) completed the study. In group 1, after zinc supplementation, urinary albumin excretion decreased significantly from 86.5 +/- 57 to 75 +/- 71 mg/g (p = 0.01). After placebo, patients in group 1 showed no significant reduction in microalbuminuria (85 +/- 72 mg/g to 83 +/- 63 mg/g creatinine). In group 2, no change in albumin excretion was observed after placebo treatment (90.5 +/- 63 mg/g to 90 +/- 60 mg/g creatinine). After zinc supplementation, a significant reduction was observed in albumin excretion, from 90 +/- 60 mg/g to 85 +/- 57 mg/g creatinine (p = 0.003).
CONCLUSIONS


Zinc supplementation reduced albumin excretion in microalbuminuric type 2diabetic patients. This outcome may be due to the antioxidant effect of zinc.",2008,"In group 2, no change in albumin excretion was observed after placebo treatment (90.5 +/-","['diabetic patients', 'Fifty diabetic patients with microalbuminuria were enrolled', '57', '60', 'patients with type 2 diabetes', 'diabetes', 'microalbuminuric type 2diabetic patients']","['zinc supplementation versus placebo', 'placebo', '30 mg elemental zinc', 'zinc supplementation', 'Zinc supplementation', 'placebo group were given zinc']","['microalbuminuria', 'urinary albumin excretion', 'albumin excretion', 'Fasting plasma glucose, HbA1c, lipid profiles, plasma zinc levels and random urine for albumin and creatinine']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0730345', 'cui_str': 'Microalbuminuria (finding)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0730345', 'cui_str': 'Microalbuminuria (finding)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0729827', 'cui_str': 'Plasma zinc measurement'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}]",50.0,0.438349,"In group 2, no change in albumin excretion was observed after placebo treatment (90.5 +/-","[{'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Parham', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Sedigheh Tahereh Research Complex, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Massoud', 'Initials': 'M', 'LastName': 'Amini', 'Affiliation': ''}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Aminorroaya', 'Affiliation': ''}, {'ForeName': 'Esfandiar', 'Initials': 'E', 'LastName': 'Heidarian', 'Affiliation': ''}]",The review of diabetic studies : RDS,['10.1900/RDS.2008.5.102']
1558,26859658,Metformin Treatment Does Not Affect Testicular Size in Offspring Born to Mothers with Gestational Diabetes.,"OBJECTIVES


Studies in rodents suggest that metformin treatment during pregnancy may have harmful effects on testicular development in offspring. Our aim was to determine whether metformin treatment of gestational diabetes mellitus (GDM) affects testicular size in male offspring.
METHODS


We compared the testicular size in prepubertal boys born to mothers who participated in a randomized controlled trial (RCT) comparing metformin with insulin in the treatment of GDM. Twenty-five (42.4% of invited) and 27 (52.9% of invited) boys whose mothers had been treated with metformin or insulin, respectively, participated in the study. Testicular size was measured by a ruler, an orchidometer, and by ultrasonography at the age of 33 to 85 months.
RESULTS


The mean age of the boys was 60 months at the time of examination, and did not differ between the metformin and insulin group (p = 0.88). There was no difference in testicular size between the boys in the two groups (p always ≥ 0.40), and there were no significant differences in height, weight, BMI, BMI z-score, or waist-to-hip ratio (WHR) between the boys in the groups.
CONCLUSIONS


Prepubertal testicular size did not differ between offspring born to metformin-treated mothers and those born to insulin-treated mothers.",2016,"There was no difference in testicular size between the boys in the two groups (p always ≥ 0.40), and there were no significant differences in height, weight, BMI, BMI z-score, or waist-to-hip ratio (WHR) between the boys in the groups.
","['Offspring Born to Mothers with Gestational Diabetes', 'gestational diabetes mellitus (GDM) affects testicular size in male offspring', 'prepubertal boys born to mothers who participated', 'Twenty-five (42.4% of invited) and 27 (52.9% of invited) boys whose mothers had been treated with']","['Metformin', 'metformin or insulin', 'metformin with insulin', 'metformin']","['height, weight, BMI, BMI z-score, or waist-to-hip ratio (WHR', 'Testicular Size', 'testicular size', 'Testicular size']","[{'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0205682', 'cui_str': 'Waist-Hip Ratio'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}]",,0.040269,"There was no difference in testicular size between the boys in the two groups (p always ≥ 0.40), and there were no significant differences in height, weight, BMI, BMI z-score, or waist-to-hip ratio (WHR) between the boys in the groups.
","[{'ForeName': 'Kristiina', 'Initials': 'K', 'LastName': 'Tertti', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Turku and Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Jorma', 'Initials': 'J', 'LastName': 'Toppari', 'Affiliation': 'Departments of Physiology and Pediatrics, University of Turku, Turku, Finland.'}, {'ForeName': 'Helena E', 'Initials': 'HE', 'LastName': 'Virtanen', 'Affiliation': 'Departments of Physiology and Pediatrics, University of Turku, Turku, Finland.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Sadov', 'Affiliation': 'Departments of Physiology and Pediatrics, University of Turku, Turku, Finland.'}, {'ForeName': 'Tapani', 'Initials': 'T', 'LastName': 'Rönnemaa', 'Affiliation': 'Department of Medicine, University of Turku and Turku University Hospital, Turku, Finland.'}]",The review of diabetic studies : RDS,['10.1900/RDS.2016.13.e2015013']
1559,17491669,Polyclonal anti-T-cell therapy for type 1 diabetes mellitus of recent onset.,"The destruction of pancreatic beta-cells in type 1 diabetes mellitus is mediated by autoreactive T-lymphocyte clones. We initiated a prospective randomized controlled trial of polyclonal rabbit anti-T-cell globulin (ATG) in patients with type 1 diabetes within 4 weeks of diagnosis and with residual post-glucagon C-peptide levels still over 0.3 nmol/l. ATG was administered as an initial bolus of 9 mg/kg followed by 3 consecutive doses of 3 mg/kg. An interim analysis was performed to establish whether any significant changes in C-peptide production and insulin requirement had occurred that would justify the continuation of this pilot study. By May 2004, 11 subjects were assigned to treatment with ATG along with intensified insulin therapy and 6 to intensified insulin therapy with placebo, and were followed for a period of at least 6 months. During the first 12 months a significant difference in the insulin dose trends was found between the groups (p = 0.010) with a lower insulin dosage in the ATG group. There was also a difference in the glucagon stimulated C-peptide level trends of marginal significance (p = 0.068). Compared to values at screening, stimulated C-peptide levels significantly improved in the ATG group (p = 0.012) but not in the placebo group. Complete diabetes remission occurred in 2 patients in the ATG and in none of the placebo group. Glycosylated hemoglobin at 12 months tended to be lower in the ATG group (p = 0.088). Significant adverse effects of ATG treatment, mainly transient fever and moderate symptoms of serum sickness (7 and 6 subjects, respectively) were observed during the first month only. The interim analysis of this ongoing study suggests that short-term ATG therapy in type 1 diabetes of recent onset contributes to the preservation of residual C-peptide production and to lower insulin requirements in the first year following diagnosis.",2004,"Compared to values at screening, stimulated C-peptide levels significantly improved in the ATG group (p = 0.012) but not in the placebo group.",['patients with type 1 diabetes within 4 weeks of diagnosis and with residual post-glucagon C-peptide levels still over 0.3 nmol/l'],"['ATG along with intensified insulin therapy and 6 to intensified insulin therapy with placebo', 'ATG', 'placebo', 'Polyclonal anti-T-cell therapy', 'polyclonal rabbit anti-T-cell globulin (ATG']","['Glycosylated hemoglobin', 'Complete diabetes remission', 'transient fever and moderate symptoms of serum sickness', 'stimulated C-peptide levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0202100', 'cui_str': 'Insulin C-peptide measurement (procedure)'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0439282', 'cui_str': 'nM'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0076533', 'cui_str': 'Thomsen-Friedenreich antibodies'}, {'cui': 'C0302189', 'cui_str': 'Cell Therapy'}, {'cui': 'C3887509', 'cui_str': 'Rabbits'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0017649', 'cui_str': 'Globulins'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036830', 'cui_str': 'Serum Sickness'}, {'cui': 'C0202100', 'cui_str': 'Insulin C-peptide measurement (procedure)'}]",11.0,0.129857,"Compared to values at screening, stimulated C-peptide levels significantly improved in the ATG group (p = 0.012) but not in the placebo group.","[{'ForeName': 'Frantisek', 'Initials': 'F', 'LastName': 'Saudek', 'Affiliation': 'Diabetes Center, Institute for Clinical and Experimental Medicine, Videnska 1958/9, 14021 Prague 4, Czech Republic. frantisek.saudek@medicon.cz'}, {'ForeName': 'Tereza', 'Initials': 'T', 'LastName': 'Havrdova', 'Affiliation': ''}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Boucek', 'Affiliation': ''}, {'ForeName': 'Ludmila', 'Initials': 'L', 'LastName': 'Karasova', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Novota', 'Affiliation': ''}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Skibova', 'Affiliation': ''}]",The review of diabetic studies : RDS,[]
1560,22580729,Acute effects of dietary fat on inflammatory markers and gene expression in first-degree relatives of type 2 diabetes patients.,"BACKGROUND


Subjects with type 2 diabetes (T2D) and their relatives (REL) carry an increased risk of cardiovascular disease (CVD). Low-grade inflammation, an independent risk factor for CVD, is modifiable by diet. Subjects with T2D show elevated postprandial inflammatory responses to fat-rich meals, while information on postprandial inflammation in REL is sparse.
AIM


To clarify whether medium-chain saturated fatty acids (SFA) and monounsaturated fatty acids (MUFA) have differential acute effects on low-grade inflammation in REL compared to controls (CON).
METHODS


In randomized order, 17 REL and 17 CON ingested two fat-rich meals, with 72 energy percent from MUFA and 79 energy percent from mainly medium-chain SFA, respectively. Plasma high sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), adiponectin, and leptin were measured at baseline, 15 min, 60 min, and 240 min postprandially. Muscle and adipose tissue biopsies were taken at baseline and 210 min after the test meal, and expression of selected genes was analyzed.
RESULTS


Plasma IL-6 increased (p < 0.001) without difference between REL and CON and between the meals, whereas plasma adiponectin and plasma hs-CRP were unchanged during the 240 min observation period. Plasma leptin decreased slightly in response to medium-chain SFA in both groups, and to MUFA in REL. Several genes were differentially regulated in muscle and adipose tissue of REL and CON.
CONCLUSIONS


MUFA and medium-chain SFA elicit similar postprandial circulating inflammatory responses in REL and CON. Medium-chain SFA seems more proinflammatory than MUFA, judged by the gene expression in muscle and adipose tissue of REL and CON.",2011,"IL-6 increased (p < 0.001) without difference between REL and CON and between the meals, whereas plasma adiponectin and plasma hs-CRP were unchanged during the 240 min observation period.","['first-degree relatives of type 2 diabetes patients', 'Subjects with type 2 diabetes (T2D) and their relatives (REL) carry an increased risk of cardiovascular disease (CVD']","['medium-chain saturated fatty acids (SFA) and monounsaturated fatty acids (MUFA', 'MUFA and medium-chain SFA', 'Medium-chain SFA', 'dietary fat']","['Muscle and adipose tissue biopsies', 'inflammatory markers and gene expression', 'IL-6', 'Plasma leptin', 'Plasma high sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), adiponectin, and leptin', 'plasma adiponectin and plasma hs-CRP']","[{'cui': 'C0444502', 'cui_str': 'First degree (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]","[{'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0597423', 'cui_str': 'Fatty Acids, Saturated'}, {'cui': 'C0015687', 'cui_str': 'Fatty Acids, Monounsaturated'}, {'cui': 'C0012171', 'cui_str': 'Dietary Fats'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}]",,0.0447891,"IL-6 increased (p < 0.001) without difference between REL and CON and between the meals, whereas plasma adiponectin and plasma hs-CRP were unchanged during the 240 min observation period.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Pietraszek', 'Affiliation': 'Department of Medicine and Endocrinology, Aarhus University Hospital, Aarhus, Denmark. annapiet@rm.dk'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Gregersen', 'Affiliation': ''}, {'ForeName': 'Kjeld', 'Initials': 'K', 'LastName': 'Hermansen', 'Affiliation': ''}]",The review of diabetic studies : RDS,['10.1900/RDS.2011.8.477']
1561,22972443,Telephone counseling intervention improves dietary habits and metabolic parameters of patients with the metabolic syndrome: a randomized controlled trial.,"BACKGROUND


Patients with the metabolic syndrome (MetS) can suffer from poor metabolic parameters through lack of adherence to requisite lifestyle changes in dietary and physical activity. Usually, interventions in MetS patients are infrequent face-to-face consultations. The low frequency or absence of counseling interviews leads to a shortage of information and motivation to adhere to the recommended lifestyle changes. Telephone interventions could be an additional low-cost tool for effective interventions.
AIM


To evaluate the effectiveness of telephone intervention in improving lifestyle habits and metabolic parameters in MetS patients compared with similar face-to-face or a usual care interventions.
METHODS


Eighty-seven MetS patients recruited from the outpatient clinic of a major public hospital were randomly assigned to one of the three intervention groups: ""usual care"", ""telephone"" or ""face-to-face"". At the beginning of the study, all patients were provided with a hypocaloric Mediterranean-type diet. Afterwards, patients in the telephone group received 7 dietary counseling calls, patients in the face-to-face group participated in 7 one-to-one dietary counseling sessions, while patients in the usual care group received no other contact until the end of the study, 6 months later. All patients underwent full medical and nutritional evaluation at the beginning and at the end of the intervention.
RESULTS


At the end of the intervention, 42% of the participants no longer showed symptoms of MetS; the reduction rates differed significantly between the groups (p = 0.024), with those in the face-to-face and telephone group exhibiting similar rates (52% and 54%, respectively, vs. 21% in the usual care group). Between-group analysis revealed that the face-to-face group achieved the greatest improvement in metabolic parameters, while the telephone group had the greatest improvement in dietary adherence compared with the usual care group.
CONCLUSIONS


Telephone counseling is an effective way to implement behavioral counseling to improve lifestyle habits in MetS patients.",2012,"At the end of the intervention, 42% of the participants no longer showed symptoms of MetS; the reduction rates differed significantly between the groups (p = 0.024), with those in the face-to-face and telephone group exhibiting similar rates (52% and 54%, respectively, vs. 21% in the usual care group).","['MetS patients compared with similar face-to-face or a usual care interventions', 'MetS patients', 'patients with the metabolic syndrome', 'Eighty-seven MetS patients recruited from the outpatient clinic of a major public hospital', 'Patients with the metabolic syndrome (MetS']","['Telephone counseling intervention', 'hypocaloric Mediterranean-type diet', 'dietary counseling calls, patients in the face-to-face group participated in 7 one-to-one dietary counseling sessions', 'Telephone counseling', 'usual care"", ""telephone"" or ""face-to-face', 'telephone intervention', 'Telephone interventions']","['metabolic parameters', 'dietary adherence', 'dietary habits and metabolic parameters', 'lifestyle habits', 'symptoms of MetS; the reduction rates', 'lifestyle habits and metabolic parameters']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C4517895', 'cui_str': 'Eighty-seven'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",87.0,0.0184539,"At the end of the intervention, 42% of the participants no longer showed symptoms of MetS; the reduction rates differed significantly between the groups (p = 0.024), with those in the face-to-face and telephone group exhibiting similar rates (52% and 54%, respectively, vs. 21% in the usual care group).","[{'ForeName': 'Evaggelia', 'Initials': 'E', 'LastName': 'Fappa', 'Affiliation': 'Department of Nutrition and Dietetics, Harokopio University, Athens, Greece.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Yannakoulia', 'Affiliation': ''}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ioannidou', 'Affiliation': ''}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Skoumas', 'Affiliation': ''}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Pitsavos', 'Affiliation': ''}, {'ForeName': 'Christodoulos', 'Initials': 'C', 'LastName': 'Stefanadis', 'Affiliation': ''}]",The review of diabetic studies : RDS,['10.1900/RDS.2012.9.36']
1562,17491710,The effect of PPARgamma-agonism on LDL subclass profile in patients with type 2 diabetes and coronary artery disease.,"Patients with type 2 diabetes (T2DM) often present a preponderance of small, dense LDL particles (small-LDL), which are associated with a high risk of myocardial infarction. Some studies suggest that PPARgamma-agonists increase LDL cholesterol but have divergent effects on various LDL subclasses in T2DM patients. We studied the effect of rosiglitazone on the LDL subclass profile in T2DM patients with verified coronary artery disease (CAD). 58 patients with T2DM (HbA1c < 8.5%) and CAD were enrolled in a 16-week, randomized, double-blind and placebo-controlled trial with rosiglitazone 8 mg/day (n = 29) or placebo (n = 29). The LDL subclass profile was measured with gel electrophoresis. Rosiglitazone improved insulin sensitivity and glycemic control. Total cholesterol did not change after rosiglitazone treatment (p = 0.062, ANCOVA adjusted for gender and baseline values), whereas LDL (including IDL) cholesterol increased from 2.33 +/- 0.48 to 2.67 +/- 0.61 mmol/l (p = 0.002 vs. baseline, p = 0.0497 vs. placebo) and large buoyant LDL (large-LDL < 250A) increased from 1.31 +/- 0.36 to 1.46 +/- 0.42 mmol/l (p = 0.010 vs. baseline, p = 0.044 vs. placebo) in the rosiglitazone group. No significant changes occurred to the concentration of small-LDL (< 250A), the average LDL particle size, or HDL or triglyceride concentrations. Whole-body insulin sensitivity was associated with the average LDL particle size after intervention in the whole population (r = 0.40, p = 0.002) and in the rosiglitazone group (r = 0.43, p = 0.020). In conclusion, in T2DM patients with CAD, rosiglitazone treatment significantly increases the concentration of large (buoyant) LDL cholesterol, but not of small dense LDL cholesterol. The long term consequences of this divergent effect of rosiglitazone on LDL subfractions require further exploration.",2006,"Total cholesterol did not change after rosiglitazone treatment (p = 0.062, ANCOVA adjusted for gender and baseline values), whereas LDL (including IDL) cholesterol increased from 2.33 +/-","['T2DM patients with CAD', 'T2DM patients with verified coronary artery disease (CAD', 'Patients with type 2 diabetes (T2DM', 'patients with type 2 diabetes and coronary artery disease', '58 patients with T2DM (HbA1c < 8.5%) and CAD']","['rosiglitazone', 'placebo', 'PPARgamma-agonism', 'Rosiglitazone']","['Total cholesterol', 'average LDL particle size, or HDL or triglyceride concentrations', 'LDL (including IDL) cholesterol', 'insulin sensitivity and glycemic control', 'concentration of small-LDL', 'LDL cholesterol', 'LDL subclass profile', 'large buoyant LDL', 'concentration of large (buoyant) LDL cholesterol', 'average LDL particle size']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4517877', 'cui_str': '8.5'}]","[{'cui': 'C0289313', 'cui_str': 'rosiglitazone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0166417', 'cui_str': 'PPAR gamma'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0030608', 'cui_str': 'Particle Size'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0445604', 'cui_str': 'Subclass (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]",58.0,0.161974,"Total cholesterol did not change after rosiglitazone treatment (p = 0.062, ANCOVA adjusted for gender and baseline values), whereas LDL (including IDL) cholesterol increased from 2.33 +/-","[{'ForeName': 'Riikka', 'Initials': 'R', 'LastName': 'Lautamäki', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Pirjo', 'Initials': 'P', 'LastName': 'Nuutila', 'Affiliation': ''}, {'ForeName': 'K E Juhani', 'Initials': 'KE', 'LastName': 'Airaksinen', 'Affiliation': ''}, {'ForeName': 'Aila', 'Initials': 'A', 'LastName': 'Leino', 'Affiliation': ''}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Hiekkanen', 'Affiliation': ''}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Turiceanu', 'Affiliation': ''}, {'ForeName': 'Murray', 'Initials': 'M', 'LastName': 'Stewart', 'Affiliation': ''}, {'ForeName': 'Juhani', 'Initials': 'J', 'LastName': 'Knuuti', 'Affiliation': ''}, {'ForeName': 'Tapani', 'Initials': 'T', 'LastName': 'Rönnemaa', 'Affiliation': ''}]",The review of diabetic studies : RDS,[]
1563,18338075,Effectiveness of an intensive nutritional intervention in patients with type 2 diabetes mellitus: results from a pilot study.,"The aim of this pilot study was to compare the effects of an intensive nutritional intervention with usual care conditions on dropout rate, body weight, lifestyle changes and glycemic control in patients with type 2 diabetes mellitus (T2DM). Thirty outpatients with T2DM but without insulin treatment (mean age: 57 +/- 9 yr) were randomly assigned to one of the two intervention groups: intensive care (IC) or usual care (UC). Patients in the UC group were given advice about dietary and physical activity goals in one consultation session at baseline, while patients in the IC group attended five goal-oriented consultation sessions held approximately every two weeks from baseline onwards. Changes in body weight, T2DM knowledge, dietary intake, physical activity, HbA1c, and percentage of dropouts were evaluated at 1-year follow-up post-intervention. Fifty percent of patients quitted the program and were classified as ""dropouts"". Program completers were older and included a lower percentage of newly diagnosed T2DM compared with dropouts. A tendency to a negative association between attendance of the IC group and the likelihood of dropping out was found (p = 0.08). No difference was detected between UC and IC groups regarding changes in body weight, HbA1c or other outcome measures, at post-intervention or 1-year follow-up. This pilot study did not confirm advantages of intensive nutritional intervention in T2DM patients in terms of glycemic control, body weight, diet and physical activity. However, the high dropout rate may have hampered its effectiveness.",2007,"No difference was detected between UC and IC groups regarding changes in body weight, HbA1c or other outcome measures, at post-intervention or 1-year follow-up.","['Thirty outpatients with T2DM but without insulin treatment (mean age: 57 ', 'patients with type 2 diabetes mellitus (T2DM', 'patients with type 2 diabetes mellitus', 'T2DM patients']","['intensive care (IC) or usual care (UC', 'intensive nutritional intervention with usual care conditions', 'intensive nutritional intervention', 'advice about dietary and physical activity goals']","['glycemic control, body weight, diet and physical activity', 'dropout rate, body weight, lifestyle changes and glycemic control', 'body weight, HbA1c or other outcome measures', 'body weight, T2DM knowledge, dietary intake, physical activity, HbA1c, and percentage of dropouts']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0085559'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0018017', 'cui_str': 'Goals'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}]",30.0,0.0253592,"No difference was detected between UC and IC groups regarding changes in body weight, HbA1c or other outcome measures, at post-intervention or 1-year follow-up.","[{'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Yannakoulia', 'Affiliation': 'Department of Nutrition and Dietetics Harokopio University, 70 El. Venizelou St, 17671, Athens, Greece.'}, {'ForeName': 'Kalliopi-Anna', 'Initials': 'KA', 'LastName': 'Poulia', 'Affiliation': ''}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Mylona', 'Affiliation': ''}, {'ForeName': 'Meropi D', 'Initials': 'MD', 'LastName': 'Kontogianni', 'Affiliation': ''}]",The review of diabetic studies : RDS,['10.1900/RDS.2007.4.226']
1564,19557297,Effect of zinc supplementation on serum homocysteine in type 2 diabetic patients with microalbuminuria.,"OBJECTIVES


Elevated homocysteine levels are considered to be an independent risk factor for cardiovascular complications in diabetic patients. The aim of this study was to find out if zinc supplementation improves homocysteine levels, which may exert vascular-protective effects in type 2 diabetes subjects with microalbuminuria.
METHODS


In a randomized, double-blind, controlled, crossover study, 50 type 2 diabetic patients with microalbuminuria were subdivided into two groups and supplemented with 30 mg/d of zinc (group 1) or placebo (group 2) for three months with a four-week wash out period. Serum creatinine, vitamin B(12), folate, fasting plasma glucose, HbA1c, lipid profiles, zinc, homocysteine levels and random urine albumin were measured before and after the first and second phase of the study in all participants.
RESULTS


Mean serum zinc was significantly increased after zinc supplementation (from 76 +/- 16 mug/dl to 93 +/- 20 microg/dl; p < 0.05), while there was no change in the placebo group (75 +/- 16 microg/dl to 75 +/- 15 microg/dl). With zinc supplementation, homocysteine levels reduced significantly (from 13.71 +/- 3.84 mumol/l to 11.79 +/- 3.06 mumol/l; p < 0.05), which did not occur on placebo (from 12.59 +/- 2.13 mumol/l to 13.36 +/- 2.03 mumol/l). Simple regression was used to show a positive correlation between urine albumin excretion and serum homocysteine (r = 0.37, p = 0.023). Vitamin B(12) and folate levels increased significantly in patients who received zinc in comparison to those who received placebo. A negative correlation was observed between homocysteine and vitamin B(12) concentration (r = -0.36, p = 0.025).
CONCLUSION


Zinc supplementation reduced serum homocysteine and increased vitamin B(12) and folate concentrations in type 2 diabetic patients with microalbuminuria.",2009,Vitamin B(12) and folate levels increased significantly in patients who received zinc in comparison to those who received placebo.,"['50 type 2 diabetic patients with microalbuminuria', 'diabetic patients', 'type 2 diabetic patients with microalbuminuria', 'type 2 diabetes subjects with microalbuminuria']","['Zinc supplementation', 'zinc', 'placebo', 'zinc supplementation']","['Vitamin B(12) and folate levels', 'homocysteine levels', 'urine albumin excretion and serum homocysteine', 'Serum creatinine, vitamin B(12), folate, fasting plasma glucose, HbA1c, lipid profiles, zinc, homocysteine levels and random urine albumin', 'serum homocysteine', 'Mean serum zinc', 'serum homocysteine and increased vitamin B(12) and folate concentrations', 'homocysteine and vitamin B(12) concentration', 'Elevated homocysteine levels']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0730345', 'cui_str': 'Microalbuminuria (finding)'}]","[{'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0042849', 'cui_str': 'Vitamin B Complex'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2242817', 'cui_str': 'Homocysteine measurement (procedure)'}, {'cui': 'C0042037'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019878', 'cui_str': '2-amino-4-mercaptobutyric acid'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0856205', 'cui_str': 'Serum zinc'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.34155,Vitamin B(12) and folate levels increased significantly in patients who received zinc in comparison to those who received placebo.,"[{'ForeName': 'Esfandiar', 'Initials': 'E', 'LastName': 'Heidarian', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Massoud', 'Initials': 'M', 'LastName': 'Amini', 'Affiliation': ''}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Parham', 'Affiliation': ''}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Aminorroaya', 'Affiliation': ''}]",The review of diabetic studies : RDS,['10.1900/RDS.2009.6.64']
1565,21409314,Effects of insulin versus sulphonylurea on beta-cell secretion in recently diagnosed type 2 diabetes patients: a 6-year follow-up study.,"BACKGROUND


Early insulin treatment is considered more beneficial than anti-diabetic medication with sulphonylureas, because the latter may exert negative effects on beta-cell function, while the former may help preserve it. In a previous study, we found that C-peptide response was increased in the insulin-treated group, whereas it was decreased in the glibenclamide group. However, it was not certain whether the advantage remained in the longer term.
AIM


In this study, we tested whether early insulin treatment is more beneficial than glibenclamide against a 6-year follow-up perspective.
METHODS


We designed a randomized clinical trial in subjects with newly diagnosed type 2 diabetes. Glucagon stimulatory tests, measuring C-peptide and islet amyloid polypeptide (IAPP), were performed after 2, and 3, days of temporary insulin and glibenclamide withdrawal.
RESULTS


18 subjects initially randomized to glibenclamide, and 16 randomized to two daily injections of insulin, participated in end-of-study investigations. C-peptide response to glucagon deteriorated (p < 0.01 vs. baseline) in initially glibenclamide-treated patients (n = 18), but not in insulin-treated patients (p < 0.05 for difference between groups, after 2 days of treatment withdrawal). The IAPP response to glucagon declined in the glibenclamide group (p < 0.001), but not in insulin-treated subjects (p = 0.05 for difference between groups).
CONCLUSIONS


Early insulin treatment preserves beta-cell secretory function better than glibenclamide even in a 6-year perspective.",2010,"The IAPP response to glucagon declined in the glibenclamide group (p < 0.001), but not in insulin-treated subjects (p = 0.05 for difference between groups).
","['18 subjects initially randomized to', 'subjects with newly diagnosed type 2 diabetes', 'recently diagnosed type 2 diabetes patients']","['glibenclamide', 'insulin versus sulphonylurea']","['beta-cell secretion', 'IAPP response to glucagon', 'beta-cell secretory function', 'Glucagon stimulatory tests, measuring C-peptide and islet amyloid polypeptide (IAPP', 'C-peptide response']","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0017628', 'cui_str': 'glibenclamide'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]","[{'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0063684', 'cui_str': 'Amylin'}]",18.0,0.145932,"The IAPP response to glucagon declined in the glibenclamide group (p < 0.001), but not in insulin-treated subjects (p = 0.05 for difference between groups).
","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Alvarsson', 'Affiliation': 'Department of Endocrinology and Diabetology, Karolinska University Hospital, Stockholm, Sweden. michael.alvarsson@karolinska.se'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Berntorp', 'Affiliation': ''}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Fernqvist-Forbes', 'Affiliation': ''}, {'ForeName': 'Ibe', 'Initials': 'I', 'LastName': 'Lager', 'Affiliation': ''}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Steen', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Orn', 'Affiliation': ''}, {'ForeName': 'Valdemar', 'Initials': 'V', 'LastName': 'Grill', 'Affiliation': ''}]",The review of diabetic studies : RDS,['10.1900/RDS.2010.7.225']
1566,24172699,Alpha-lipoic acid improves subclinical left ventricular dysfunction in asymptomatic patients with type 1 diabetes.,"BACKGROUND


Oxidative stress plays an important role in the development of diabetic cardiomyopathy. Alpha-lipoic acid (ALA) is a powerful antioxidant that may have a protective role in diabetic cardiac dysfunction.
AIM


We investigated the possible beneficial effect of alpha-lipoic acid on diabetic left ventricular (LV) dysfunction in children and adolescents with asymptomatic type 1 diabetes (T1D).
SUBJECTS AND METHODS


Thirty T1D patients (aged 10-14) were randomized to receive insulin treatment (n = 15) or insulin plus alpha-lipoic acid 300 mg twice daily (n = 15) for four months. Age and sex matched healthy controls (n = 15) were also included. Patients were evaluated with conventional 2-dimensional echocardiographic examination (2D), pulsed tissue Doppler (PTD), and 2-dimensional longitudinal strain echocardiography (2DS) before and after therapy. Glutathione, malondialdhyde (MDA), nitric oxide (NO), tumor necrosis factor-alpha (TNF-alpha), Fas ligand (Fas-L), matrix metalloproteinase 2 (MMP-2), and troponin-I were determined and correlated to echocardiographic parameters.
RESULTS


Diabetic patients had significantly lower levels of glutathione and significantly higher MDA, NO, TNF-alpha, Fas-L, MMP-2, and troponin-I levels than control subjects. The expression of transforming growth factor beta (TGF-beta) mRNA in peripheral blood mononuclear cells was also increased in diabetic patients. Significant correlations of mitral e'/a' ratio and left ventricular global peak systolic strain with glutathione, MDA, NO, TNF-alpha, and Fas-L were observed in diabetic patients. Alpha-lipoic acid significantly increased glutathione level and significantly decreased MDA, NO, TNF-alpha, Fas-L, MMP-2, troponin-I levels, and TGF-beta gene expression. Moreover, alpha-lipoic acid significantly increased mitral e'/a' ratio and left ventricular global peak systolic strain in diabetic patients.
CONCLUSION


These findings suggest that alpha-lipoic acid may have a role in preventing the development of diabetic cardiomyopathy in type 1 diabetes.",2013,"Alpha-lipoic acid significantly increased glutathione level and significantly decreased MDA, NO, TNF-alpha, Fas-L, MMP-2, troponin-I levels, and TGF-beta gene expression.","['Diabetic patients', 'diabetic patients', 'Age and sex matched healthy controls (n = 15', 'Thirty T1D patients (aged 10-14', 'asymptomatic patients with type 1 diabetes', 'children and adolescents with asymptomatic type 1 diabetes (T1D']","['Alpha-lipoic acid (ALA', 'insulin treatment', 'conventional 2-dimensional echocardiographic examination (2D), pulsed tissue Doppler (PTD), and 2-dimensional longitudinal strain echocardiography (2DS', 'insulin plus alpha-lipoic acid', 'Alpha-lipoic acid', 'alpha-lipoic acid']","['diabetic left ventricular (LV) dysfunction', ""mitral e'/a' ratio and left ventricular global peak systolic strain"", ""mitral e'/a' ratio and left ventricular global peak systolic strain with glutathione, MDA, NO, TNF-alpha, and Fas-L"", 'glutathione level', 'MDA, NO, TNF-alpha, Fas-L, MMP-2, troponin-I levels, and TGF-beta gene expression', 'Glutathione, malondialdhyde (MDA), nitric oxide (NO), tumor necrosis factor-alpha (TNF-alpha), Fas ligand (Fas-L), matrix metalloproteinase 2 (MMP-2), and troponin-I', 'subclinical left ventricular dysfunction', 'expression of transforming growth factor beta (TGF-beta) mRNA in peripheral blood mononuclear cells', 'levels of glutathione and significantly higher MDA, NO, TNF-alpha, Fas-L, MMP-2, and troponin']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}]","[{'cui': 'C0023791', 'cui_str': 'alpha-lipoic acid'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0242698', 'cui_str': 'Ventricular Dysfunction, Left'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic, function (observable entity)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C0920210', 'cui_str': 'Troponin I measurement (procedure)'}, {'cui': 'C0040690', 'cui_str': 'Bone-Derived Transforming Growth Factor'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0253023', 'cui_str': 'Fas Ligand'}, {'cui': 'C0172537', 'cui_str': '72-kDa Type IV Collagenase'}, {'cui': 'C0205211', 'cui_str': 'Subclinical (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0523952', 'cui_str': 'Troponin measurement'}]",15.0,0.0278538,"Alpha-lipoic acid significantly increased glutathione level and significantly decreased MDA, NO, TNF-alpha, Fas-L, MMP-2, troponin-I levels, and TGF-beta gene expression.","[{'ForeName': 'Sahar K', 'Initials': 'SK', 'LastName': 'Hegazy', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Tanta University, Egypt.'}, {'ForeName': 'Osama A', 'Initials': 'OA', 'LastName': 'Tolba', 'Affiliation': ''}, {'ForeName': 'Tarek M', 'Initials': 'TM', 'LastName': 'Mostafa', 'Affiliation': ''}, {'ForeName': 'Manal A', 'Initials': 'MA', 'LastName': 'Eid', 'Affiliation': ''}, {'ForeName': 'Dalia R', 'Initials': 'DR', 'LastName': 'El-Afify', 'Affiliation': ''}]",The review of diabetic studies : RDS,['10.1900/RDS.2013.10.58']
1567,31617926,Assessment of Sarcopenia Among Community-Dwelling At-Risk Frail Adults Aged 65 Years and Older Who Received Multidomain Lifestyle Interventions: A Secondary Analysis of a Randomized Clinical Trial.,"Importance


There is little understanding of the outcomes associated with active lifestyle interventions for sarcopenia among older persons.
Objective


To determine the association of 6-month multidomain lifestyle interventions (physical exercise, nutritional enhancement, cognitive training, combined treatment, and standard care) with change in sarcopenia status and physical function among adults 65 years and older.
Design, Setting, and Participants


Post hoc secondary analysis of a parallel-group randomized clinical trial conducted from September 1, 2012, to September 1, 2014, at community centers providing services to elderly individuals in Singapore. Participants included a subsample of 92 community-dwelling prefrail or frail older persons with sarcopenia aged 65 years and older. Data were analyzed from June 1, 2017, to January 1, 2018.
Interventions


The 5 intervention groups were a 6-month duration of physical exercise that included resistance and balance training, nutritional enhancement with a commercial oral nutrition supplement formula, cognitive training, a combination of the preceding 3 interventions, and standard care (control).
Main Outcomes and Measures


Primary outcomes were changes in sarcopenia status and its components, appendicular skeletal muscle index (ASMI), knee extension strength (KES), and gait speed (GS) at 3 months and 6 months following the intervention. Sarcopenia was defined as the presence of both low ASMI and low KES and/or GS.
Results


In 92 participants with sarcopenia, the mean (SD) age was 70.0 (4.7) years and 59 (64.1%) were female. Seventy-eight participants received active interventions and 14 received standard care. Of 92 total participants, the number who remained sarcopenic was reduced to 48 (of 73) after 3 months and 51 (of 75) after 6 months of intervention, indicating that 25 of 92 participants (27.2%) experienced sarcopenia reduction at 3 months and 24 of 92 (26.1%) had sarcopenia reduction at 6 months. Low KES was present in 88 of 92 patients (95.6%), and low GS in 30 of 92 patients (32.6%) at baseline. Among the components of sarcopenia, GS had the greatest change associated with active interventions, with 22 of 30 participants (73.3%) free of low GS at 6 months; in comparison, 17 of 88 participants (19.3%) were free of low KES at 6 months and 7 of 92 participants (7.6%) were free of low ASMI at 6 months. Men experienced greater reduction in sarcopenia than women (χ2 = 5.925; P = .02), as did those with younger age (t = -2.078; P = .04) or higher ASMI (mean [SD] ASMI, 5.74 [0.77] vs 5.14 [0.77] kg/m2; P = .002). Participants in the active intervention group experienced statistically significant decreases in sarcopenia score and its components at 3 months and 6 months from baseline (F = 14.138; P < .001), but the intervention was not associated with significant differences in ASMI, KES, and GS vs standard care.
Conclusions and Relevance


This study suggests that older persons with sarcopenia are responsive to the effects of multidomain lifestyle interventions. Sarcopenia reduction was most pronounced through improved gait speed, and occurred more among those who were male, were younger, or had greater muscle mass.",2019,"Participants in the active intervention group experienced statistically significant decreases in sarcopenia score and its components at 3 months and 6 months from baseline (F = 14.138; P < .001), but the intervention was not associated with significant differences in ASMI, KES, and GS vs standard care.
","['older persons with sarcopenia', 'September 1, 2012, to September 1, 2014, at community centers providing services to elderly individuals in Singapore', '92 participants with sarcopenia, the mean (SD) age was 70.0 (4.7) years and 59 (64.1%) were female', 'Community-Dwelling At-Risk Frail Adults', 'adults 65 years and older', 'Participants included a subsample of 92 community-dwelling prefrail or frail older persons with sarcopenia aged 65 years and older', 'Aged 65 Years and Older']","['physical exercise that included resistance and balance training, nutritional enhancement with a commercial oral nutrition supplement formula, cognitive training, a combination of the preceding 3 interventions, and standard care (control', 'multidomain lifestyle interventions (physical exercise, nutritional enhancement, cognitive training, combined treatment, and standard care', 'Multidomain Lifestyle Interventions', 'active interventions and 14 received standard care']","['ASMI', 'gait speed', 'sarcopenia reduction', 'Sarcopenia reduction', 'reduction in sarcopenia', 'changes in sarcopenia status and its components, appendicular skeletal muscle index (ASMI), knee extension strength (KES), and gait speed (GS', 'ASMI, KES, and GS vs standard care', 'number who remained sarcopenic', 'sarcopenia score']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenias'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenias'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",78.0,0.0611313,"Participants in the active intervention group experienced statistically significant decreases in sarcopenia score and its components at 3 months and 6 months from baseline (F = 14.138; P < .001), but the intervention was not associated with significant differences in ASMI, KES, and GS vs standard care.
","[{'ForeName': 'Yanxia', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Singapore Immunology Network, Biology of Ageing Laboratory, Agency for Science Technology and Research, Biopolis, Singapore.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Niti', 'Affiliation': 'Performance and Technology Assessment Department, Ministry of Health, Singapore.'}, {'ForeName': 'Keng Bee', 'Initials': 'KB', 'LastName': 'Yap', 'Affiliation': 'Geriatric Medicine and Palliative Medicine Department, Ng Teng Fong General Hospital, Singapore.'}, {'ForeName': 'Crystal Tze Ying', 'Initials': 'CTY', 'LastName': 'Tan', 'Affiliation': 'Singapore Immunology Network, Biology of Ageing Laboratory, Agency for Science Technology and Research, Biopolis, Singapore.'}, {'ForeName': 'Ma Shwe', 'Initials': 'MS', 'LastName': 'Zin Nyunt', 'Affiliation': 'Gerontology Research Programme, Yong Loo Lin School of Medicine, Department of Psychological Medicine, National University Health System, National University of Singapore, Singapore.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': 'Gerontology Research Programme, Yong Loo Lin School of Medicine, Department of Psychological Medicine, National University Health System, National University of Singapore, Singapore.'}, {'ForeName': 'Boon Yeow', 'Initials': 'BY', 'LastName': 'Tan', 'Affiliation': ""Medical Services Department, St Luke's Hospital, Singapore.""}, {'ForeName': 'Gribson', 'Initials': 'G', 'LastName': 'Chan', 'Affiliation': ""Rehabilitation Services Division, St Luke's Hospital, Singapore.""}, {'ForeName': 'Sue Anne', 'Initials': 'SA', 'LastName': 'Khoo', 'Affiliation': 'Psychological Medicine Department, Khoo Teck Puat Hospital, Singapore.'}, {'ForeName': 'Sue Mei', 'Initials': 'SM', 'LastName': 'Chan', 'Affiliation': 'Nutrition and Dietetics Department, Khoo Teck Puat Hospital, Singapore.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Yap', 'Affiliation': 'Geriatric Medicine Department, Khoo Teck Puat Hospital, Singapore.'}, {'ForeName': 'Anis', 'Initials': 'A', 'LastName': 'Larbi', 'Affiliation': 'Singapore Immunology Network, Biology of Ageing Laboratory, Agency for Science Technology and Research, Biopolis, Singapore.'}, {'ForeName': 'Tze Pin', 'Initials': 'TP', 'LastName': 'Ng', 'Affiliation': 'Gerontology Research Programme, Yong Loo Lin School of Medicine, Department of Psychological Medicine, National University Health System, National University of Singapore, Singapore.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.13346']
1568,31629355,"Effects of Home- and Center-Based Exercise Programs on the Strength, Function, and Gait of Prefrail Older Women: A Randomized Control Trial.","The aims of this study were to compare the effects of a multicomponent exercise program provided at a center (CB) versus done part at home and part at a center (H+CB) on frailty status, strength, physical function, and gait of prefrail older women. Twenty-five women were randomly allocated into the CB (n = 14; 69 ± 6 years) and the H+CB (n = 11; 69 ± 7 years) groups. Both groups completed an exercise program including strengthening, balance, and gait exercises. The program was 12 weeks long, done three times per week, for 60 min per session. Frailty, knee and hip muscle strength, spatiotemporal parameters of the usual and maximum speed dual-task gait, and physical function were assessed at baseline and after program completion. The exercise program reversed the prefrail status of most participants independently of the mode of delivery. Strength increased in both groups, but the CB group had more pronounced improvements in gait and physical function. H+CB exercise programs are good options for prefrail older women.",2020,"Strength increased in both groups, but the CB group had more pronounced improvements in gait and physical function.","['Prefrail Older Women', 'prefrail older women', 'Twenty-five women']","['Home- and Center-Based Exercise Programs', 'H+CB', 'H+CB exercise programs', 'multicomponent exercise program provided at a center (CB) versus done part at home and part at a center (H+CB', 'exercise program including strengthening, balance, and gait exercises']","['frailty status, strength, physical function, and gait', 'gait and physical function', 'Strength, Function, and Gait', 'Frailty, knee and hip muscle strength, spatiotemporal parameters of the usual and maximum speed dual-task gait, and physical function', 'Strength']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3715062', 'cui_str': '25'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}]","[{'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",25.0,0.0228729,"Strength increased in both groups, but the CB group had more pronounced improvements in gait and physical function.","[{'ForeName': 'Sabrine N', 'Initials': 'SN', 'LastName': 'Costa', 'Affiliation': ''}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Vieira', 'Affiliation': ''}, {'ForeName': 'Paulo C B', 'Initials': 'PCB', 'LastName': 'Bento', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2018-0363']
1569,31629363,It's Not Just Physical: Exercise Physiologist-Led Exercise Program Promotes Functional and Psychosocial Health Outcomes in Aged Care.,"Regular physical activity has multiple benefits for older adults, including improved physical, cognitive, and psychosocial health. This exploratory study investigated the benefits of a 12-week exercise program for older adults (n = 11 control and n = 13 intervention) living in a residential aged care facility in Perth, Western Australia. The program, prescribed and delivered by an accredited exercise physiologist, aimed to maintain or improve participants' physical capacity. It comprised one-on-one exercise sessions (1 hr × 2 days/week × 12 weeks), involving a components-approach intervention. Physical performance measures (balance, strength, flexibility, and mobility) were assessed preintervention and postintervention. Qualitative interviews postintervention with residents participating in the exercise intervention, and with family members, staff, and research team members, explored barriers and enablers to participation and perceived psychosocial outcomes. Findings indicate the program provided physical benefits and enhanced social engagement for participants, illustrating the value of providing exercise physiology services in the aged care sector.",2020,"The program, prescribed and delivered by an accredited exercise physiologist, aimed to maintain or improve participants' physical capacity.","['Aged Care', 'residents participating in the exercise intervention, and with family members, staff, and research team members, explored barriers and enablers to participation and perceived psychosocial outcomes', 'older adults', 'n = 13 intervention) living in a residential aged care facility in Perth, Western Australia', 'older adults (n = 11 control and', ""It's Not Just Physical""]","['Exercise Physiologist-Led Exercise Program', 'exercise program']","['Physical performance measures (balance, strength, flexibility, and mobility']","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0035168'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043128', 'cui_str': 'Western Australia'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0260141', 'cui_str': 'Physiologist (occupation)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C2607857'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}]",,0.014102,"The program, prescribed and delivered by an accredited exercise physiologist, aimed to maintain or improve participants' physical capacity.","[{'ForeName': 'Annette J', 'Initials': 'AJ', 'LastName': 'Raynor', 'Affiliation': ''}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Iredale', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Crowther', 'Affiliation': ''}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'White', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Dare', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2019-0088']
1570,31619250,Assessing the Integrated Community-Based Health Systems Strengthening initiative in northern Togo: a pragmatic effectiveness-implementation study protocol.,"BACKGROUND


Over the past decade, prevalence of maternal and child morbidity and mortality in Togo, particularly in the northern regions, has remained high despite global progress. The causes of under-five child mortality in Togo are diseases with effective and low-cost prevention and/or treatment strategies, including malaria, acute lower respiratory infections, and diarrheal diseases. While Togo has a national strategy for implementing the integrated management of childhood illness (IMCI) guidelines, including a policy on integrated community case management (iCCM), challenges in implementation and low public sector health service utilization persist. There are critical gaps to access and quality of community health systems throughout the country. An integrated facility- and community-based initiative, the Integrated Community-Based Health Systems Strengthening (ICBHSS) initiative, seeks to address these gaps while strengthening the public sector health system in northern Togo. This study aims to evaluate the effect and implementation strategy of the ICBHSS initiative over 48 months in the catchment areas of 21 public sector health facilities.
METHODS


The ICBHSS model comprises a bundle of evidence-based interventions targeting children under five, women of reproductive age, and people living with HIV through (1) community engagement and feedback; (2) elimination of point-of-care costs; (3) proactive community-based IMCI using community health workers (CHWs) with additional services including family planning, HIV testing, and referrals; (4) clinical mentoring and enhanced supervision; and (5) improved supply chain management and facility structures. Using a pragmatic type II hybrid effectiveness-implementation study, we will evaluate the ICBHSS initiative with two primary aims: (1) determine effectiveness through changes in under-five mortality rates and (2) assess the implementation strategy through measures of reach, adoption, implementation, and maintenance. We will conduct a mixed-methods assessment using the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework. This assessment consists of four components: (1) a stepped-wedge cluster randomized control trial using a community-based household survey, (2) annual health facility assessments, (3) key informant interviews, and (4) costing and return-on-investment assessments for each randomized cluster.
DISCUSSION


Our research is expected to contribute to continuous quality improvement initiatives, optimize implementation factors, provide knowledge regarding health service delivery, and accelerate health systems improvements in Togo and more broadly.
TRIAL REGISTRATION


ClinicalTrials.gov , NCT03694366 , registered 3 October 2018.",2019,"An integrated facility- and community-based initiative, the Integrated Community-Based Health Systems Strengthening (ICBHSS) initiative, seeks to address these gaps while strengthening the public sector health system in northern Togo.","['over 48\u2009months in the catchment areas of 21 public sector health facilities', 'northern Togo']","['community-based household survey, (2) annual health facility assessments, (3) key informant interviews, and (4) costing and return-on-investment assessments', 'Integrated Community-Based Health Systems Strengthening initiative', 'proactive community-based IMCI using community health workers (CHWs) with additional services including family planning, HIV testing, and referrals; (4) clinical mentoring and enhanced supervision; and (5) improved supply chain management and facility structures', 'ICBHSS initiative']",[],"[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0007403', 'cui_str': 'Health Service Area'}, {'cui': 'C0034035', 'cui_str': 'Public Sector'}, {'cui': 'C0018704', 'cui_str': 'Health Facilities'}, {'cui': 'C0040363', 'cui_str': 'Togolese Republic'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0018704', 'cui_str': 'Health Facilities'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0021953', 'cui_str': 'Investments'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0009861', 'cui_str': 'Family Planning Services'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C4255266', 'cui_str': 'Mentoring'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}]",[],21.0,0.057075,"An integrated facility- and community-based initiative, the Integrated Community-Based Health Systems Strengthening (ICBHSS) initiative, seeks to address these gaps while strengthening the public sector health system in northern Togo.","[{'ForeName': 'Molly E', 'Initials': 'ME', 'LastName': 'Lauria', 'Affiliation': 'Community Health Systems Lab, Integrate Health/Santé Intégrée, Kara, Togo. mlauria@integratehealth.org.'}, {'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Fiori', 'Affiliation': 'Community Health Systems Lab, Integrate Health/Santé Intégrée, Kara, Togo.'}, {'ForeName': 'Heidi E', 'Initials': 'HE', 'LastName': 'Jones', 'Affiliation': 'CUNY Graduate School of Public Health & Health Policy, New York, USA.'}, {'ForeName': 'Sesso', 'Initials': 'S', 'LastName': 'Gbeleou', 'Affiliation': 'Integrate Health/Santé Intégrée, Kara, Togo.'}, {'ForeName': 'Komlan', 'Initials': 'K', 'LastName': 'Kenkou', 'Affiliation': 'Integrate Health/Santé Intégrée, Kara, Togo.'}, {'ForeName': 'Sibabe', 'Initials': 'S', 'LastName': 'Agoro', 'Affiliation': 'Kara Regional Health Department, Ministry of Health and Public Hygiene, Kara, Togo.'}, {'ForeName': 'Abdourahmane Diparidé', 'Initials': 'AD', 'LastName': 'Agbèrè', 'Affiliation': 'Department of Pediatrics, Health Sciences Faculty, University of Lomé, Lomé, Togo.'}, {'ForeName': 'Kelly D', 'Initials': 'KD', 'LastName': 'Lue', 'Affiliation': 'Community Health Systems Lab, Integrate Health/Santé Intégrée, Kara, Togo.'}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Hirschhorn', 'Affiliation': 'Community Health Systems Lab, Integrate Health/Santé Intégrée, Kara, Togo.'}]",Implementation science : IS,['10.1186/s13012-019-0921-3']
1571,31629060,"A Randomized, Double-Blind, Placebo-Controlled, Phase III Noninferiority Study of the Long-Term Safety and Efficacy of Darbepoetin Alfa for Chemotherapy-Induced Anemia in Patients With Advanced NSCLC.","INTRODUCTION


This study evaluated noninferiority of darbepoetin alfa versus placebo for overall survival (OS) and progression-free survival (PFS) in anemic patients with NSCLC treated to a 12.0-g/dL hemoglobin (Hb) ceiling.
METHODS


Adults with stage IV NSCLC expected to receive two or more cycles of myelosuppressive chemotherapy and Hb less than or equal to 11.0 g/dL were randomized 2:1 to blinded 500 μg darbepoetin alfa or placebo every 3 weeks. The primary endpoint was OS; a stratified Cox proportional hazards model was used to evaluate noninferiority (upper confidence limit for hazard ratio [HR] < 1.15). Secondary endpoints were PFS and incidence of transfusions or Hb less than or equal to 8.0 g/dL from week 5 to end of the efficacy treatment period.
RESULTS


The primary analysis set included 2516 patients: 1680 were randomized to darbepoetin alfa; 836 to placebo. The study was stopped early per independent Data Monitoring Committee recommendation after the primary endpoint was met with no new safety concerns. Darbepoetin alfa was noninferior to placebo for OS (stratified HR = 0.92; 95% confidence interval [CI]: 0.83‒1.01) and PFS (stratified HR = 0.95; 95% CI: 0.87‒1.04). Darbepoetin alfa was superior to placebo for transfusion or Hb less than or equal to 8.0 g/dL from week 5 to end of the efficacy treatment period (stratified odds ratio = 0.70; 95% CI: 0.57‒0.86; p < 0.001). Objective tumor response was similar between the groups (darbepoetin alfa, 36.4%; placebo, 32.6%). Incidence of serious adverse events was 31.1% in both groups. No unexpected adverse events were observed.
CONCLUSIONS


Darbepoetin alfa dosed to a 12.0-g/dL Hb ceiling was noninferior to placebo for OS and PFS and significantly reduced odds of transfusion or Hb less than or equal to 8.0 g/dL in anemic patients with NSCLC receiving myelosuppressive chemotherapy.",2020,"Darbepoetin alfa was superior to placebo for transfusion or Hb ≤8.0 g/dL from week 5 to EOETP (stratified OR=0.70; 95%CI, 0.57‒0.86; P<.001).","['anemic patients with non-small cell lung cancer (NSCLC) treated to a 12.0-g/dL hemoglobin (Hb) ceiling', 'Adults with stage IV NSCLC expected to receive ≥2 cycles of myelosuppressive chemotherapy and Hb≤11.0 g/dL', '2516 patients: 1680 randomized to', 'Patients With Advanced Non-Small Cell Lung Cancer', 'anemic patients with NSCLC receiving myelosuppressive chemotherapy']","['Placebo', 'darbepoetin alfa versus placebo', 'placebo', 'Darbepoetin alfa', 'Q3W', 'darbepoetin alfa or placebo', 'darbepoetin alfa']","['PFS and incidence of transfusions or Hb≤8.0 g/dL from week 5 to end of the efficacy treatment period (EOETP', 'Objective tumor response', 'overall survival (OS) and progression-free survival (PFS', 'Incidence of serious adverse events (AEs']","[{'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4517596', 'cui_str': '1680'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0937950', 'cui_str': 'darbepoetin alfa'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1680.0,0.645383,"Darbepoetin alfa was superior to placebo for transfusion or Hb ≤8.0 g/dL from week 5 to EOETP (stratified OR=0.70; 95%CI, 0.57‒0.86; P<.001).","[{'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Gascón', 'Affiliation': 'Department of Hematology-Oncology, Hospital Clínic de Barcelona, University of Barcelona, Barcelona, Spain. Electronic address: gascon@clinic.cat.'}, {'ForeName': 'Rajnish', 'Initials': 'R', 'LastName': 'Nagarkar', 'Affiliation': 'Curie Manavata Cancer Center, Nashik, India.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Šmakal', 'Affiliation': 'Nemocnice Hořovice, NH Hospital a.s., Hořovice, Czech Republic.'}, {'ForeName': 'Konstantinos N', 'Initials': 'KN', 'LastName': 'Syrigos', 'Affiliation': 'Third Department of Medicine, Athens Medical School, Athens, Greece.'}, {'ForeName': 'Carlos H', 'Initials': 'CH', 'LastName': 'Barrios', 'Affiliation': 'Centro de Pesquisa em Oncologia, PUCRS, Porto Alegre, Brazil.'}, {'ForeName': 'Jesús Cárdenas', 'Initials': 'JC', 'LastName': 'Sánchez', 'Affiliation': 'Centro Medico de Colima, Colima, Mexico.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Sun Yat-Sen University Cancer Center, East Guangzhou, China.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Henry', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gordon', 'Affiliation': 'Cancer Care Centers of South Texas and US Oncology Research Network, San Antonio, Texas.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Hirsh', 'Affiliation': 'MUHC Royal Victoria Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Kubota', 'Affiliation': 'Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Orlov', 'Affiliation': 'Saint Petersburg State Medical University, Saint Petersburg, Russian Federation.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Thomas', 'Affiliation': 'South Carolina Cancer Specialists, Hilton Head Island, South Carolina.'}, {'ForeName': 'Tilman', 'Initials': 'T', 'LastName': 'Steinmetz', 'Affiliation': 'Gemeinschaftspraxis für Hämatologie und Onkologie, Köln, Germany.'}, {'ForeName': 'Jin-Hyoung', 'Initials': 'JH', 'LastName': 'Kang', 'Affiliation': 'The Catholic University of Korea, Seoul, South Korea.'}, {'ForeName': 'Dianne K', 'Initials': 'DK', 'LastName': 'Tomita', 'Affiliation': 'Amgen Inc., Thousand Oaks, California.'}, {'ForeName': 'Alexander N', 'Initials': 'AN', 'LastName': 'Fleishman', 'Affiliation': 'Amgen Inc., Thousand Oaks, California.'}, {'ForeName': 'Joseph K', 'Initials': 'JK', 'LastName': 'Park', 'Affiliation': 'Amgen Inc., Thousand Oaks, California.'}, {'ForeName': 'Cisio', 'Initials': 'C', 'LastName': 'De Oliveira Brandao', 'Affiliation': 'Amgen Inc., Thousand Oaks, California.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2019.10.005']
1572,31627907,[Does sentinel lymph node identification has indication in digestive cancers?],"Despite being a standard of care in several cancers, sentinel lymph node (SLN) is not widespread in digestive cancers. European guidelines do not recommend its use for any digestive cancers. Particularity of the lymphatic vessel, intimately linked to blood vessel, may explain part of this phenomenon. Nevertheless, more indication could arise in the near future with the early diagnosis of tumor induced by cancer screening. Ruling out the lymphatic invasion could allow preserving the organ currently resected because of risk of lymph node positivity. This procedure is well studied in early gastric cancer in Korea and Japan. Several study have demonstrated that, a dual-tracer (isotopic and dye) allows to accurately identify the SLN. A randomized phase 3 trial is currently active in Korea to evaluate the oncological results of the procedure. Similar indication could arise for T1 tumor of the low-rectum, but currently available data are insufficient to recommend its use outside of a study. SLN may also be used to detect aberrant lymphatic drainage (rectum, ileum) but have been tested so far only in a few dozen of patients. Finally, SLN is disappointing in colon cancer, due to its low sensitivity and the absence of modification of the surgical procedure induced.",2020,"SLN may also be used to detect aberrant lymphatic drainage (rectum, ileum) but have been tested so far only in a few dozen of patients.",['early gastric cancer in Korea and Japan'],['SLN'],[],"[{'cui': 'C0349530', 'cui_str': 'Early gastric cancer (disorder)'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]",[],[],,0.0592617,"SLN may also be used to detect aberrant lymphatic drainage (rectum, ileum) but have been tested so far only in a few dozen of patients.","[{'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Faron', 'Affiliation': 'Gustave-Roussy Cancer Campus, département de chirurgie viscérale oncologique, 114, rue Édouard-Vaillant, 94805 Villejuif cedex, France; Unité Inserm 1018 CESP Oncostat, Gustave-Roussy Cancer Campus, département de biostatistiques et épidémiologie, 114, rue Édouard-Vaillant, 94805 Villejuif cedex, France. Electronic address: matthieu.faron@gustaveroussy.fr.'}, {'ForeName': 'Enora', 'Initials': 'E', 'LastName': 'Laas', 'Affiliation': ""Institut Curie, service de chirurgie senologique, gynécologique et reconstructrice, 26, rue d'Ulm, 75005 Paris, France.""}]",Bulletin du cancer,['10.1016/j.bulcan.2019.06.013']
1573,31621523,"Improving HbA 1c  with Glucose Self-Monitoring in Diabetic Patients with EpxDiabetes, a Phone Call and Text Message-Based Telemedicine Platform: A Randomized Controlled Trial.","Background:   We conducted a randomized controlled trial of EpxDiabetes, a novel digital health intervention as an adjunct therapy to reduce HbA 1c  and fasting blood glucose (FBG) among patients with type 2 diabetes mellitus (T2DM). In addition, we examined the effect of social determinants of health on our system.   Methods:   Sixty-five ( n  = 65) patients were randomized at a primary care clinic. Self-reported FBG data were collected by EpxDiabetes automated phone calls or text messages. Only intervention group responses were shared with providers, facilitating follow-up and bidirectional communication. ΔHbA 1c  and ΔFBG were analyzed after 6 months.   Results:   There was an absolute HbA 1c  reduction of 0.69% in the intervention group (95% confidence interval [CI], -1.41 to 0.02) and an absolute reduction of 0.03% in the control group (95% CI, -0.88 to 0.82). For those with baseline HbA 1c  >8%, HbA 1c  decreased significantly by 1.17% in the intervention group (95% CI, -1.90 to -0.44), and decreased by 0.02% in the control group (95% CI, -0.99 to 0.94). FBG decreased in the intervention group by 21.6 mg/dL (95% CI, -37.56 to -5.639), and increased 13.0 mg/dL in the control group (95% CI, -47.67 to 73.69). Engagement (proportion responding to ≥25% of texts or calls over 4 weeks) was 58% for the intervention group (95% CI, 0.373-0.627) and 48% for the control group (95% CI, 0.296-0.621). Smoking, number of comorbidities, and response rate were significant predictors of ΔHbA 1c .   Conclusions:   EpxDiabetes helps to reduce HbA 1c  in patients with uncontrolled T2DM and fosters patient-provider communication; it has definite merit as an adjunct therapy in diabetes management. Future work will focus on improving the acceptability of the system and implementation on a larger scale trial.",2020,"FBG decreased in the intervention group by 21.6 mg/dL (95% CI, -37.56 to -5.639), and increased 13.0 mg/dL in the control group (95% CI, -47.67 to 73.69).","['Diabetic Patients with EpxDiabetes', 'Methods:   Sixty-five ( n \u2009=\u200965', 'patients with type 2 diabetes mellitus (T2DM']",['novel digital health intervention'],"['FBG', 'HbA 1c  and fasting blood glucose (FBG', 'HbA 1c', 'Smoking, number of comorbidities, and response rate', 'ΔHbA 1c  and ΔFBG']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",,0.0600336,"FBG decreased in the intervention group by 21.6 mg/dL (95% CI, -37.56 to -5.639), and increased 13.0 mg/dL in the control group (95% CI, -47.67 to 73.69).","[{'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Xing', 'Affiliation': 'Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Kavon', 'Initials': 'K', 'LastName': 'Javaherian', 'Affiliation': 'Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Peters', 'Affiliation': 'Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Will', 'Initials': 'W', 'LastName': 'Ross', 'Affiliation': 'Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Bernal-Mizrachi', 'Affiliation': 'Division of Endocrinology, Metabolism and Lipid Research, Washington University School of Medicine, St. Louis, Missouri, USA.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2019.0035']
1574,29299790,Mobile Health Technology for Improving Symptom Management in Low Income Persons Living with HIV.,"Persons living with HIV (PLWH) are living longer but experiencing more adverse symptoms associated with the disease and its treatment. This study aimed to examine the impact of a mHealth application (app) comprised of evidence-based self-care strategies on the symptom experience of PLWH. We conducted a 12-week feasibility study with 80 PLWH who were randomized (1:1) to a mHealth app, mobile Video Information Provider (mVIP), with self-care strategies for improving 13 commonly experienced symptoms in PLWH or to a control app. Intervention group participants showed a significantly greater improvement than the control group in 5 symptoms: anxiety (p = 0.001), depression (p = 0.001), neuropathy (p = 0.002), fever/chills/sweat (p = 0.037), and weight loss/wasting (p = 0.020). Participants in the intervention group showed greater improvement in adherence to their antiretroviral medications (p = 0.017) as compared to those in the control group. In this 12-week trial, mVIP was associated with improved symptom burden and increased medication adherence in PLWH.",2018,"Intervention group participants showed a significantly greater improvement than the control group in 5 symptoms: anxiety (p = 0.001), depression (p = 0.001), neuropathy (p = 0.002), fever/chills/sweat (p = 0.037), and weight loss/wasting (p = 0.020).","['80 PLWH', 'Low Income Persons Living with HIV', 'Persons living with HIV (PLWH']","['mHealth application (app', 'mHealth app, mobile Video Information Provider (mVIP), with self-care strategies', 'Mobile Health Technology']","['5 symptoms: anxiety', 'depression', 'adherence to their antiretroviral medications', 'weight loss/wasting', 'symptom burden and increased medication adherence', 'fever/chills/sweat', 'neuropathy']","[{'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0085593', 'cui_str': 'Chills'}, {'cui': 'C0038990', 'cui_str': 'Sweating'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}]",80.0,0.0561322,"Intervention group participants showed a significantly greater improvement than the control group in 5 symptoms: anxiety (p = 0.001), depression (p = 0.001), neuropathy (p = 0.002), fever/chills/sweat (p = 0.037), and weight loss/wasting (p = 0.020).","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Schnall', 'Affiliation': 'Columbia University School of Nursing, New York, NY, 10032, USA. rb897@columbia.edu.'}, {'ForeName': 'Hwayoung', 'Initials': 'H', 'LastName': 'Cho', 'Affiliation': 'Columbia University School of Nursing, New York, NY, 10032, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Mangone', 'Affiliation': 'Columbia University School of Nursing, New York, NY, 10032, USA.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Pichon', 'Affiliation': 'Columbia University School of Nursing, New York, NY, 10032, USA.'}, {'ForeName': 'Haomiao', 'Initials': 'H', 'LastName': 'Jia', 'Affiliation': 'Columbia University School of Nursing, New York, NY, 10032, USA.'}]",AIDS and behavior,['10.1007/s10461-017-2014-0']
1575,31628016,"Tumour Treating Fields in combination with pemetrexed and cisplatin or carboplatin as first-line treatment for unresectable malignant pleural mesothelioma (STELLAR): a multicentre, single-arm phase 2 trial.","BACKGROUND


Tumour Treating Fields (TTFields) are a regional, antimitotic treatment for solid tumours, which is based on the delivery of low-intensity alternating electric fields. The aim of the STELLAR study was to test the activity of TTFields delivered to the thorax in combination with systemic chemotherapy for the front-line treatment of patients with unresectable malignant pleural mesothelioma.
METHODS


STELLAR was a prospective, single-arm, phase 2 trial done at 12 European academic and non-academic sites (five in Italy, three in Poland, one in France, one in Belgium, one in Spain, and one in the Netherlands) for treatment-naive patients with histologically confirmed unresectable malignant pleural mesothelioma. Patients were aged at least 18 years, had an Eastern Cooperative Oncology Group performance status of 0-1, and at least one measurable or evaluable lesion according to modified Response Evaluation Criteria in Solid Tumors for mesothelioma. Patients received continuous TTFields at a frequency of 150 kHz to the thorax and concomitant chemotherapy with intravenous pemetrexed (500 mg/m 2  on day 1) plus intravenous platinum (either cisplatin 75 mg/m 2  on day 1 or carboplatin area under the curve 5 on day 1) every 21 days for up to six cycles. Patients not progressing after completion of chemotherapy received TTFields as maintenance treatment until progression, patient or physician decision, or unacceptable toxic effects. The primary endpoint of the trial was overall survival. Survival analyses were done in the intention-to-treat population, and safety analyses were done in all patients who received at least 1 day of TTFields treatment. This trial is registered with ClinicalTrials.gov, NCT02397928.
FINDINGS


Between Feb 9, 2015 and March 21, 2017, 80 patients were enrolled in the study. Median follow-up was 12·5 months (IQR 7·4-16·6). Median overall survival was 18·2 months (95% CI 12·1-25·8). The most common grade 3 or worse adverse events were anaemia (nine [11%] patients), neutropenia (seven [9%]), and thrombocytopenia (four [5%]). Skin reaction was the only adverse event associated with TTFields and was reported as grade 1-2 in 53 (66%) patients, and as grade 3 in four (5%) patients. No treatment-related deaths were observed.
INTERPRETATION


The trial showed encouraging overall survival results, with no increase in systemic toxicity. TTFields (150 kHz) delivered to the thorax concomitant with pemetrexed and platinum was an active and safe combination for front-line treatment of unresectable malignant pleural mesothelioma. Further investigation in a randomised trial is warranted.
FUNDING


Novocure.",2019,"No treatment-related deaths were observed.
","['Patients were aged at least 18 years, had an Eastern Cooperative Oncology Group performance status of 0-1, and at least one measurable or evaluable lesion according to modified Response Evaluation Criteria in Solid Tumors for mesothelioma', 'patients with unresectable malignant pleural mesothelioma', 'STELLAR was a prospective, single-arm, phase 2 trial done at 12 European academic and non-academic sites (five in Italy, three in Poland, one in France, one in Belgium, one in Spain, and one in the Netherlands) for treatment-naive patients with histologically confirmed unresectable malignant pleural mesothelioma', 'unresectable malignant pleural mesothelioma (STELLAR', 'Between Feb 9, 2015 and March 21, 2017', '80 patients were enrolled in the study']","['thorax concomitant with pemetrexed and platinum', 'intravenous platinum (either cisplatin 75 mg/m 2  on day 1 or carboplatin', 'thorax in combination with systemic chemotherapy', 'pemetrexed and cisplatin or carboplatin', 'thorax and concomitant chemotherapy with intravenous pemetrexed']","['systemic toxicity', 'overall survival', 'Skin reaction', 'neutropenia', 'Median overall survival', 'thrombocytopenia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0025500', 'cui_str': 'Mesothelioma'}, {'cui': 'C0812413', 'cui_str': 'Malignant mesothelioma of pleura (disorder)'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0032356', 'cui_str': 'Republic of Poland'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}]","[{'cui': 'C4552199', 'cui_str': 'Systemic toxicity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction (observable entity)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}]",80.0,0.234487,"No treatment-related deaths were observed.
","[{'ForeName': 'Giovanni L', 'Initials': 'GL', 'LastName': 'Ceresoli', 'Affiliation': 'Department of Oncology, Cliniche Humanitas Gavazzeni, Bergamo, Italy. Electronic address: giovanni_luca.ceresoli@gavazzeni.it.'}, {'ForeName': 'Joachim G', 'Initials': 'JG', 'LastName': 'Aerts', 'Affiliation': 'Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Rafal', 'Initials': 'R', 'LastName': 'Dziadziuszko', 'Affiliation': 'Department of Oncology and Radiotherapy, Medical University of Gdansk, Gdansk, Poland.'}, {'ForeName': 'Rodryg', 'Initials': 'R', 'LastName': 'Ramlau', 'Affiliation': 'Department of Oncology, University of Poznan, Poznan, Poland.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Cedres', 'Affiliation': ""Medical Oncology, Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Jan P', 'Initials': 'JP', 'LastName': 'van Meerbeeck', 'Affiliation': 'Department of Pulmonology and Thoracic Oncology, ERN-Lung, Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Manlio', 'Initials': 'M', 'LastName': 'Mencoboni', 'Affiliation': 'SSD Oncologia, Ospedale Villa Scassi, ASL 3 Genovese, Genova, Italy.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Planchard', 'Affiliation': 'Department of Thoracic Oncology, Institute Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Chella', 'Affiliation': 'Department of Oncology, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Crinò', 'Affiliation': 'Medical Oncology Division, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, IRCCS, Meldola, Italy.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Krzakowski', 'Affiliation': 'Department of Lung Cancer and Chest Tumours, Maria Skłodowska-Curie Memorial Cancer Centre, Warsaw, Poland.'}, {'ForeName': 'Jörn', 'Initials': 'J', 'LastName': 'Rüssel', 'Affiliation': 'Department of Haematology and Oncology, University Hospital Halle (Saale), Halle (Saale), Germany.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Maconi', 'Affiliation': 'Scientific Research and Development Department, Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy.'}, {'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Gianoncelli', 'Affiliation': 'Department of Oncology, Cliniche Humanitas Gavazzeni, Bergamo, Italy; Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Grosso', 'Affiliation': 'Mesothelioma Unit, Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30532-7']
1576,31628558,"Pulsed Nd:YAG laser: effects on pain, postural stability, and weight-bearing pattern in children with hemophilic ankle arthropathy.","Hemophilic ankle arthropathy features joint pain, impaired postural control, and abnormal weight-bearing pattern. This study was designed to investigate the effects of pulsed Nd:YAG laser on pain, postural stability, and weight-bearing pattern in children with hemophilic ankle arthropathy. Forty children diagnosed with hemophilia type A (age, 8-16 years) were randomly allocated to either the treatment group (n = 20) who received a three-phase active therapy with pulsed Nd:YAG laser thrice/week (total energy was 1500 J) plus a physical exercise program for four consecutive weeks, or the placebo group (n = 20) who received placebo laser plus the physical exercise program. Pain, postural control (i.e., directional control [DC], endpoint excursion [EE], center-of-gravity movement velocity [CoG-MV], and maximum excursion [MXE]), and weight-bearing pattern (i.e., pressure peaks of the hindfoot [PP-HF] and forefoot [PP-FF], and the foot contact area [FCA]) were assessed pre- and post-treatment. The treatment group showed greater improvement in pain (P = .004), DC (P = .02), EE (P = .003), and CoG-MV (P = .003) compared to the placebo group. However, there was no statistically significant difference between both groups regarding the MXE (P = .15). In addition, the treatment group achieved favorable improvements in PP-HF (P = .003), PP-FF (P = .027), and FCA (P = .002) relative to the placebo group. Pulsed Nd:YAG laser is a potentially effective therapy for pain relief, postural control enhancement, and weight-bearing pattern adjustment in children with hemophilic ankle arthropathy.",2020,"The treatment group showed greater improvement in pain (P = .004), DC (P = .02), EE (P = .003), and CoG-MV (P = .003) compared to the placebo group.","['Forty children diagnosed with hemophilia type A (age, 8-16 years', 'children with hemophilic ankle arthropathy']","['placebo laser plus the physical exercise program', 'placebo', 'three-phase active therapy with pulsed Nd:YAG laser thrice/week (total energy was 1500 J) plus a physical exercise program', 'pulsed Nd:YAG laser', 'Pulsed Nd:YAG laser']","['CoG-MV', 'DC', 'Pain, postural control (i.e., directional control [DC], endpoint excursion [EE], center-of-gravity movement velocity [CoG-MV], and maximum excursion [MXE]), and weight-bearing pattern (i.e., pressure peaks of the hindfoot [PP-HF] and forefoot [PP-FF], and the foot contact area [FCA', 'pain', 'FCA', 'pain, postural stability, and weight-bearing pattern', 'PP-HF', 'PP-FF']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1321589', 'cui_str': 'Hemophilia - specialty'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0741040', 'cui_str': 'Ankle arthropathy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0587723', 'cui_str': 'Lasers, Yttrium Aluminum Garnet'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517582', 'cui_str': '1500'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0282189', 'cui_str': 'Gravity'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0085086', 'cui_str': 'Finding of weight-bearing'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0230459', 'cui_str': 'Hindfoot (body structure)'}, {'cui': 'C1510667', 'cui_str': 'Forefoot region of foot'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]",40.0,0.0831787,"The treatment group showed greater improvement in pain (P = .004), DC (P = .02), EE (P = .003), and CoG-MV (P = .003) compared to the placebo group.","[{'ForeName': 'Ragab K', 'Initials': 'RK', 'LastName': 'Elnaggar', 'Affiliation': 'Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt. rke_pt2001@yahoo.com.'}]",Lasers in medical science,['10.1007/s10103-019-02889-z']
1577,31523057,Understanding of prognosis in non-metastatic prostate cancer: a randomised comparative study of clinician estimates measured against the PREDICT prostate prognostic model.,"PREDICT Prostate is an individualised prognostic model that provides long-term survival estimates for men diagnosed with non-metastatic prostate cancer ( www.prostate.predict.nhs.uk ). In this study clinician estimates of survival were compared against model predictions and its potential value as a clinical tool was assessed. Prostate cancer (PCa) specialists were invited to participate in the study. 190 clinicians (63% urologists, 17% oncologists, 20% other) were randomised into two groups and shown 12 clinical vignettes through an online portal. Each group viewed opposing vignettes with clinical information alone, or alongside PREDICT Prostate estimates. 15-year clinician survival estimates were compared against model predictions and reported treatment recommendations with and without seeing PREDICT estimates were compared. 155 respondents (81.6%) reported counselling new PCa patients at least weekly. Clinician estimates of PCa-specific mortality exceeded PREDICT estimates in 10/12 vignettes. Their estimates for treatment survival benefit at 15 years were over-optimistic in every vignette, with mean clinician estimates more than 5-fold higher than PREDICT Prostate estimates. Concomitantly seeing PREDICT Prostate estimates led to significantly lower reported likelihoods of recommending radical treatment in 7/12 (58%) vignettes, particularly in older patients. These data suggest clinicians overestimate cancer-related mortality and radical treatment benefit. Using an individualised prognostic tool may help reduce overtreatment.",2019,PREDICT Prostate is an individualised prognostic model that provides long-term survival estimates for men diagnosed with non-metastatic prostate cancer ( www.prostate.predict.nhs.uk ).,"['non-metastatic prostate cancer', 'Prostate cancer (PCa) specialists', 'men diagnosed with non-metastatic prostate cancer ( www.prostate.predict.nhs.uk ', '190 clinicians (63% urologists, 17% oncologists, 20% other']",[],"['PCa-specific mortality', '15-year clinician survival estimates']","[{'cui': 'C1282496', 'cui_str': 'Metastasis from malignant tumor of prostate'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0260314', 'cui_str': 'Urologists'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}]",[],"[{'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]",,0.0282638,PREDICT Prostate is an individualised prognostic model that provides long-term survival estimates for men diagnosed with non-metastatic prostate cancer ( www.prostate.predict.nhs.uk ).,"[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Thurtle', 'Affiliation': 'Academic Urology Group, University of Cambridge, Cambridge, UK. dt433@cam.ac.uk.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Jenkins', 'Affiliation': 'Sussex Health Outcomes Research & Education in Cancer, University of Sussex, Brighton, UK.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Pharoah', 'Affiliation': 'Centre for Cancer Genetic Epidemiology, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Gnanapragasam', 'Affiliation': 'Academic Urology Group, University of Cambridge, Cambridge, UK.'}]",British journal of cancer,['10.1038/s41416-019-0569-4']
1578,31616932,"A Moderate-Fat Diet with One Avocado per Day Increases Plasma Antioxidants and Decreases the Oxidation of Small, Dense LDL in Adults with Overweight and Obesity: A Randomized Controlled Trial.","BACKGROUND


Avocados are a nutrient-dense source of MUFAs and are rich in antioxidants. Avocados have an additional LDL cholesterol (LDL-C) lowering effect beyond that observed when their MUFAs are substituted for SFAs, especially on small, dense LDL (sdLDL) particles, which are susceptible to in vivo oxidation and associated with increased risk of cardiovascular disease (CVD).
OBJECTIVES


We investigated whether a healthy diet with 1 avocado daily decreased the following secondary outcomes: circulating oxidized LDL (oxLDL) and related oxidative stress markers.
METHODS


A randomized, crossover, controlled feeding trial was conducted with 45 men and women, aged 21-70 y, with overweight or obesity and elevated LDL-C (25th-90th percentile). Three cholesterol-lowering diets were provided (5 wk each) in random sequences: a lower-fat (LF) diet (24% calories from fat-7% SFAs, 11% MUFAs, 6% PUFAs) and 2 moderate-fat (MF) diets (34% calories from fat-6% SFAs, 17% MUFAs, 9% PUFAs): the avocado (AV) diet included 1 Hass avocado (∼136 g) per day, and the MF diet used high oleic acid oils to match the fatty acid profile of 1 avocado. A general linear mixed model was used to analyze the treatment effects.
RESULTS


Compared with baseline, the AV diet significantly decreased circulating oxLDL (-7.0 U/L, -8.8%, P = 0.0004) and increased plasma lutein concentration (19.6 nmol/L, 68.7%, P < 0.0001), and both changes differed significantly from that after the MF and LF diets (P ≤ 0.05). The change in oxLDL caused by the AV diet was significantly correlated with the changes in the number of sdLDL particles (r = 0.32, P = 0.0002) but not large, buoyant LDL particles.
CONCLUSIONS


One avocado a day in a heart-healthy diet decreased oxLDL in adults with overweight and obesity, and the effect was associated with the reduction in sdLDL. This trial was registered at http://www.clinicaltrials.gov as NCT01235832.",2020,"U/L, -8.8%, P = 0.0004) and increased plasma lutein concentration (19.6 nmol/L, 68.7%, P < 0.0001), and both changes differed significantly from that after the MF and LF diets (P ≤ 0.05).","['45 men and women, aged 21-70 y, with overweight or obesity and elevated LDL-C (25th-90th percentile', 'Adults with Overweight and Obesity']","['oxidized LDL (oxLDL', 'avocado (AV) diet included 1 Hass avocado (∼136 g) per day, and the MF diet used high oleic acid oils']","['plasma lutein concentration', 'number of sdLDL particles', 'circulating oxLDL', 'Oxidation of Small, Dense LDL']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0348035', 'cui_str': 'oxidized low density lipoprotein'}, {'cui': 'C0330230', 'cui_str': 'Avocado'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0028929', 'cui_str': 'Oleic Acids'}, {'cui': 'C0028908', 'cui_str': 'Oils'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0348035', 'cui_str': 'oxidized low density lipoprotein'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}]",,0.0615617,"U/L, -8.8%, P = 0.0004) and increased plasma lutein concentration (19.6 nmol/L, 68.7%, P < 0.0001), and both changes differed significantly from that after the MF and LF diets (P ≤ 0.05).","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Nutritional Sciences, Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Tao', 'Affiliation': 'Department of Food Science, Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Hao', 'Affiliation': 'Department of Nutritional Sciences, Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Todd H', 'Initials': 'TH', 'LastName': 'Stanley', 'Affiliation': 'Department of Food Science, Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Kuan-Hsun', 'Initials': 'KH', 'LastName': 'Huang', 'Affiliation': 'Department of Nutritional Sciences, Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Lambert', 'Affiliation': 'Department of Food Science, Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Penny M', 'Initials': 'PM', 'LastName': 'Kris-Etherton', 'Affiliation': 'Department of Nutritional Sciences, Pennsylvania State University, University Park, PA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxz231']
1579,31616933,A Community-Based Early Childhood Development Center Platform Promoting Diversified Diets and Food Production Increases the Mean Probability of Adequacy of Intake of Preschoolers in Malawi: A Cluster Randomized Trial.,"BACKGROUND


Young children in Malawi consume low-quality diets lacking micronutrients critical for their development.
OBJECTIVE


To evaluate the impact of an agriculture and nutrition behavior change communication (BCC) intervention implemented through community-based childcare centers on the nutrient adequacy of diets of children living in food-insecure settings in Malawi.
METHODS


A cluster randomized trial was undertaken in 60 community-based childcare centers, including 1248 children aged 3-6 y. Nutrient intakes were estimated using interactive, multipass 24-h recall. Dietary adequacy was estimated through the probability of adequacy (PA) and mean probability of adequacy (MPA) of 11 micronutrients. Impacts were assessed by difference-in-difference (DID) estimates, adjusted for geographic clustering and child age and sex.
RESULTS


Intervention groups were similar for most baseline characteristics. Loss to follow-up was low (7% over a 12-mo period) and participation in the intervention was high (>90% enrollment and 80% attendance during the 5 d before the survey). Positive impacts were found for the PA of several individual micronutrient intakes: vitamin A [DID: 9 percentage points (pp), SE 3 pp], vitamin C (14 pp, SE 3 pp), riboflavin (11 pp, SE 3 pp), zinc (8 pp, SE 3 pp), and for the MPA for the 11 nutrients considered (5 pp, SE 1 pp). These impacts were driven by effects on younger children (aged 3-4 y).
CONCLUSIONS


Using a preschool platform to implement a nutrition-sensitive BCC intervention is an effective strategy to improve the adequacy of micronutrient intake of preschool children in food-insecure settings. The trial was registered at ISCRCTN as ISCRCTN96497560.",2020,"Positive impacts were found for the PA of several individual micronutrient intakes: vitamin A [DID: 9 percentage points (pp), SE 3 pp], vitamin C (14 pp, SE 3 pp), riboflavin (11 pp, SE 3 pp), zinc (8 pp, SE 3 pp), and for the MPA for the 11 nutrients considered (5 pp, SE 1 pp).","['Young children', '60 community-based childcare centers, including 1248 children aged 3-6 y. Nutrient intakes', 'younger children (aged 3-4 y', 'community-based childcare centers on the nutrient adequacy of diets of children living in food-insecure settings in Malawi', 'Preschoolers in Malawi', 'preschool children in food-insecure settings']","['agriculture and nutrition behavior change communication (BCC) intervention', 'vitamin C', 'nutrition-sensitive BCC intervention', 'riboflavin']",['probability of adequacy (PA) and mean probability of adequacy (MPA'],"[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}]","[{'cui': 'C0001829', 'cui_str': 'Farming'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1274143', 'cui_str': 'Communication treatments and procedures'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0373720', 'cui_str': 'Vitamin B2'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",1248.0,0.214536,"Positive impacts were found for the PA of several individual micronutrient intakes: vitamin A [DID: 9 percentage points (pp), SE 3 pp], vitamin C (14 pp, SE 3 pp), riboflavin (11 pp, SE 3 pp), zinc (8 pp, SE 3 pp), and for the MPA for the 11 nutrients considered (5 pp, SE 1 pp).","[{'ForeName': 'Aulo', 'Initials': 'A', 'LastName': 'Gelli', 'Affiliation': 'International Food Policy Research Institute (IFPRI), Washington, DC, USA.'}, {'ForeName': 'Phuong Hong', 'Initials': 'PH', 'LastName': 'Nguyen', 'Affiliation': 'International Food Policy Research Institute (IFPRI), Washington, DC, USA.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Santacroce', 'Affiliation': 'International Food Policy Research Institute (IFPRI), Washington, DC, USA.'}, {'ForeName': 'Aisha', 'Initials': 'A', 'LastName': 'Twalibu', 'Affiliation': 'Save the Children, International/Malawi, Washington, DC, USA/Zomba, Malawi.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Margolies', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Mangani', 'Initials': 'M', 'LastName': 'Katundu', 'Affiliation': 'Chancellor College, University of Malawi, Zomba, Malawi.'}]",The Journal of nutrition,['10.1093/jn/nxz245']
1580,29252039,"Effects of Whey Protein Supplementation Associated With Resistance Training on Muscular Strength, Hypertrophy, and Muscle Quality in Preconditioned Older Women.","The purpose of this study was to investigate the effect of whey protein (WP) supplementation on muscular strength, hypertrophy, and muscular quality in older women preconditioned to resistance training (RT). In a randomized, double-blind, and placebo (PLA)-controlled design, 31 older women (67.4 ± 4.0 years, 62.0 ± 6.9 kg, 155.9 ± 5.7 cm, and 25.5 ± 2.4 kg/m 2 ) received either 35 g of WP (n = 15) or 35 g of PLA (n = 16) over a 12-week study period while performing an RT program three times a week. Dietary intake, one-repetition maximum test, and skeletal muscle mass by dual-energy X-ray absorptiometry were assessed before and after the intervention period. Both groups showed significant (p < .05) improvements in skeletal muscle mass and total strength, and the WP group realized greater increases (p < .05) in these measures compared with PLA (skeletal muscle mass: WP = +4.8% vs. PLA = +2.3%; strength: WP = +8.7% vs. PLA = +4.9%). Muscular quality increased (p < .05) in both groups (WP = +2.9% vs. PLA = +1.5%) without statistical differences (p > .05) noted between conditions. We conclude that WP supplementation in combination with RT induces higher increases in both strength and hypertrophy in older women preconditioned to RT.",2018,"Both groups showed significant (p < .05) improvements in skeletal muscle mass and total strength, and the WP group realized greater increases (p < .05) in these measures compared with PLA (skeletal muscle mass: WP = +4.8% vs. PLA = +2.3%; strength: WP = +8.7% vs. PLA = +4.9%).","['older women preconditioned to resistance training (RT', 'Preconditioned Older Women', '31 older women (67.4\u2009±\u20094.0 years, 62.0\u2009±\u20096.9\xa0kg, 155.9\u2009±\u20095.7\xa0cm, and 25.5\u2009±\u20092.4\xa0kg/m 2 ', 'older women preconditioned to RT']","['Whey Protein Supplementation', 'whey protein (WP) supplementation', '35\xa0g of WP (n\u2009=\u200915) or 35\xa0g of PLA', 'Resistance Training', 'placebo (PLA)-controlled']","['muscular strength, hypertrophy, and muscular quality', 'Muscular Strength, Hypertrophy, and Muscle Quality', 'skeletal muscle mass and total strength', 'Dietary intake, one-repetition maximum test, and skeletal muscle mass by dual-energy X-ray absorptiometry', 'strength and hypertrophy', 'Muscular quality']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1709632', 'cui_str': 'Precondition (attribute)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C4517795', 'cui_str': 'Five point seven'}, {'cui': 'C4517663', 'cui_str': 'Twenty-five point five'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}]",31.0,0.0626052,"Both groups showed significant (p < .05) improvements in skeletal muscle mass and total strength, and the WP group realized greater increases (p < .05) in these measures compared with PLA (skeletal muscle mass: WP = +4.8% vs. PLA = +2.3%; strength: WP = +8.7% vs. PLA = +4.9%).","[{'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Sugihara Junior', 'Affiliation': 'Londrina State University.'}, {'ForeName': 'Alex S', 'Initials': 'AS', 'LastName': 'Ribeiro', 'Affiliation': 'University of Northern Paraná.'}, {'ForeName': 'Hellen C G', 'Initials': 'HCG', 'LastName': 'Nabuco', 'Affiliation': 'Londrina State University.'}, {'ForeName': 'Rodrigo R', 'Initials': 'RR', 'LastName': 'Fernandes', 'Affiliation': 'Londrina State University.'}, {'ForeName': 'Crisieli M', 'Initials': 'CM', 'LastName': 'Tomeleri', 'Affiliation': 'Londrina State University.'}, {'ForeName': 'Paolo M', 'Initials': 'PM', 'LastName': 'Cunha', 'Affiliation': 'Londrina State University.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Venturini', 'Affiliation': 'Londrina State University.'}, {'ForeName': 'Décio S', 'Initials': 'DS', 'LastName': 'Barbosa', 'Affiliation': 'Londrina State University.'}, {'ForeName': 'Brad J', 'Initials': 'BJ', 'LastName': 'Schoenfeld', 'Affiliation': 'CUNY Lehman College.'}, {'ForeName': 'Edilson S', 'Initials': 'ES', 'LastName': 'Cyrino', 'Affiliation': 'Londrina State University.'}]",International journal of sport nutrition and exercise metabolism,['10.1123/ijsnem.2017-0253']
1581,31609297,Cognitive Impairment during High-Intensity Exercise: Influence of Cerebral Blood Flow.,"PURPOSE


Cognitive performance appears to be impaired during high-intensity exercise, and this occurs concurrently with a reduction in cerebral blood flow (CBF). However, it is unclear whether cognitive impairment during high-intensity exercise is associated with reduced CBF. We tested the hypothesis that a reduction in CBF is responsible for impaired cognitive performance during high-intensity exercise.
METHODS


Using a randomized crossover design 17 healthy males performed spatial delayed response and Go/No-Go tasks in three conditions (exercise [EX], exercise+CO2 [EX+CO2], and a nonexercising control [CON]). In the EX and EX+CO2, they performed cognitive tasks at rest and during 8 min of moderate and high-intensity exercise. Exercise intensity corresponded to ~50% (moderate) and ~80% (high) of peak oxygen uptake. In the EX+CO2, the participants inspired hypercapnic gas (2% CO2) during high-intensity exercise. In the CON, they performed the cognitive tasks without exercise.
RESULTS


Middle cerebral artery mean velocity increased during high-intensity exercise in the EX+CO2 relative to the EX (69.4 [10.6] cm·s, vs 57.2 [7.7] cm·s, P < 0.001). Accuracy of the cognitive tasks was impaired during high-intensity exercise in the EX (84.1% [13.3%], P < 0.05) and the EX+ CO2 (85.7 [11.6%], P < 0.05) relative to rest (EX: 95.1% [5.3%], EX+CO2: 95.1 [5.3%]). However, no differences between the EX and the EX+CO2 were observed (P > 0.10). These results demonstrate that restored CBF did not prevent cognitive impairment during high-intensity exercise.
CONCLUSIONS


We conclude that a reduction in CBF is not responsible for impaired cognitive performance during high-intensity exercise.",2020,"Accuracy of the cognitive tasks was impaired during high-intensity exercise in the EX [84.1 (13.3) %, P < 0.05] and the EX+CO2 [85.7 (11.6) %, P < 0.05] relative to rest [EX: 95.1 (5.3) %,",['seventeen healthy males performed spatial delayed-response (DR) and Go'],"['conditions [Exercise (EX), Exercise+CO2 (EX+CO2', 'High-Intensity Exercise', 'EX+CO2']","['Accuracy of the cognitive tasks', 'cognitive impairment', 'peak oxygen uptake', 'Cerebral Blood Flow', 'Middle cerebral artery mean velocity (MCAv', 'EX+CO2', 'Exercise intensity', 'cerebral blood flow (CBF', 'Cognitive Impairment']","[{'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C0149566', 'cui_str': 'Middle Cerebral Artery'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",17.0,0.0392428,"Accuracy of the cognitive tasks was impaired during high-intensity exercise in the EX [84.1 (13.3) %, P < 0.05] and the EX+CO2 [85.7 (11.6) %, P < 0.05] relative to rest [EX: 95.1 (5.3) %,","[{'ForeName': 'Takaaki', 'Initials': 'T', 'LastName': 'Komiyama', 'Affiliation': 'Graduate School of Sports and Health Science, Fukuoka University, Fukuoka, JAPAN.'}, {'ForeName': 'Yukiya', 'Initials': 'Y', 'LastName': 'Tanoue', 'Affiliation': 'Graduate School of Sports and Health Science, Fukuoka University, Fukuoka, JAPAN.'}, {'ForeName': 'Mizuki', 'Initials': 'M', 'LastName': 'Sudo', 'Affiliation': 'Meiji Yasuda Life Foundation of Health and Welfare, Tokyo, JAPAN.'}, {'ForeName': 'Joseph T', 'Initials': 'JT', 'LastName': 'Costello', 'Affiliation': 'Extreme Environments Laboratory, Department of Sport and Exercise Science, University of Portsmouth, Portsmouth, UNITED KINGDOM.'}, {'ForeName': 'Yoshinari', 'Initials': 'Y', 'LastName': 'Uehara', 'Affiliation': 'Faculty of Sports Science, Fukuoka University, Fukuoka, JAPAN.'}, {'ForeName': 'Yasuki', 'Initials': 'Y', 'LastName': 'Higaki', 'Affiliation': 'Faculty of Sports Science, Fukuoka University, Fukuoka, JAPAN.'}, {'ForeName': 'Soichi', 'Initials': 'S', 'LastName': 'Ando', 'Affiliation': 'Graduate School of Informatics and Engineering, The University of Electro-Communications, Tokyo, JAPAN.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002183']
1582,31610946,Radiation exposure during direct versus indirect image acquisition during fluoroscopy-controlled internal fixation of a hip fracture: Results of a randomized controlled trial.,"BACKGROUND


Intra-operative image acquisition can be obtained indirectly (via verbal request to a technician) or directly (executed at the tableside, by a surgeon stepping on a foot pedal). Direct image acquisition could reduce the exposure time and thus the risk of radiation damage. The aim of this randomized controlled trial was to compare direct surgeon-controlled fluoroscopy with indirect technician-operated fluoroscopy during internal fixation of a hip fracture.
METHODS


From March 5, 2014 to August 19, 2015, 100 patients who had sustained a hip fracture that required internal fixation were enrolled. Patients were randomized between direct surgeon-controlled image acquisition using a foot pedal (n = 52) and indirect image acquisition by a radiology technician (n = 48). The primary outcome measure was the radiation exposure time; secondary outcome measures were the associated effective radiation dose and the dose area product.
(DAP) RESULTS


A total of 96 patients (with a median age of 84 years) were enrolled in this study. Eighty-nine (93%) patients had a pertrochanteric fracture. No statistically significant differences between direct image acquisition and indirect image acquisition were found for overall radiation time, total radiation dose or DAP for the total population. When adjusted for potential confounders, a difference in overall radiation time of 18.50 s (95% CI 2.19; 34.81, p = 0.027) was found in favour of indirect image acquisition.
CONCLUSION


This study showed statistically significantly lower radiation duration using indirect fluoroscopy for the total population and the pertrochanteric fracture subgroup when adjusted for several confounders. No significant effect on radiation dose and DAP was found.",2019,"No statistically significant differences between direct image acquisition and indirect image acquisition were found for overall radiation time, total radiation dose or DAP for the total population.","['From March 5, 2014 to August 19, 2015', 'a hip fracture', '100 patients who had sustained a hip fracture that required internal fixation were enrolled', '96 patients (with a median age of 84 years', 'Eighty-nine (93%) patients had a pertrochanteric fracture']","['direct surgeon-controlled fluoroscopy with indirect technician-operated fluoroscopy', 'indirect fluoroscopy', 'Radiation exposure during direct versus indirect image acquisition during fluoroscopy-controlled internal fixation of', 'direct surgeon-controlled image acquisition using a foot pedal (n\u202f=\u202f52) and indirect image acquisition by a radiology technician']","['direct image acquisition and indirect image acquisition', 'effective radiation dose and the dose area product', 'radiation dose and DAP', 'overall radiation time, total radiation dose or DAP', 'radiation exposure time', 'overall radiation time']","[{'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0281883', 'cui_str': 'Pertrochanteric fracture (disorder)'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0439852', 'cui_str': 'Indirect (qualifier value)'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation (event)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0034599', 'cui_str': 'Radiology'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0439852', 'cui_str': 'Indirect (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0525921', 'cui_str': 'alpha,beta-diacryloxypropionic acid'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation (event)'}]",100.0,0.157601,"No statistically significant differences between direct image acquisition and indirect image acquisition were found for overall radiation time, total radiation dose or DAP for the total population.","[{'ForeName': 'Gert R', 'Initials': 'GR', 'LastName': 'Roukema', 'Affiliation': 'Department of Surgery, Maasstad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'De Jong', 'Affiliation': 'Department of Surgery, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045 PM Rotterdam, the Netherlands. Electronic address: l.jong2@franciscus.nl.'}, {'ForeName': 'Veronique A J I M', 'Initials': 'VAJIM', 'LastName': 'Van Rijckevorsel', 'Affiliation': 'Department of Surgery, Maasstad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'Robbert S', 'Initials': 'RS', 'LastName': 'Van Onkelen', 'Affiliation': 'Trauma Research Unit Department of Surgery, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Joost A', 'Initials': 'JA', 'LastName': 'Bekken', 'Affiliation': 'Department of Surgery, Maasstad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'Cornelis H', 'Initials': 'CH', 'LastName': 'Van der Vlies', 'Affiliation': 'Department of Surgery, Maasstad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'Esther M M', 'Initials': 'EMM', 'LastName': 'Van Lieshout', 'Affiliation': 'Trauma Research Unit Department of Surgery, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands.'}]",Injury,['10.1016/j.injury.2019.09.035']
1583,31610948,Comparison of low-profile locking plate fixation versus antegrade intramedullary nailing for unstable metacarpal shaft fractures--A prospective comparative study.,"BACKGROUND


The purpose of this study was to compare the effectiveness of mini-open antegrade intramedullary nailing (AIN) and open reduction and internal fixation (ORIF) using the low-profile locking plate for angulated metacarpal shaft fractures, through prospective comparative trial.
METHODS


Group 1 (mini-open AIN; 40 patients) and the other consecutive patients in group 2 (locking plate; 35 patients) who met our inclusion/exclusion criteria were investigated between January 2010 and December 2016. We compared radiological findings (e.g., union and residual angulation or shortening); clinical conditions (e.g., pain, measured on a visual analog scale (VAS), and Disabilities of the Arm, Shoulder, and Hand (DASH) scores); active range of motion (ROM); and grip strength.
RESULTS


Union was achieved in both groups without any major complications. The final angulation measurements were not significantly different (p = 0.402). The final VAS scores were not different (p = 0.868); however, the final DASH score was better in group 1 than in group 2 (p = 0.034). The plates were removed in 14 patients at 9.6 months postoperatively for various reasons. Mean ROM at the time of hardware removal in these 14 patients was significantly lower compared with the final ROM in groups 1 and 2 (non-removal patients). Final grip strengths recovered significantly more in group 1 than in group 2 (p = 0.029). Extension lag was found in four patients in group 2, and the mean amount was 15°; however, it was resolved by tenolysis during hardware removal.
CONCLUSIONS


Both mini-open AIN and low-profile plate fixation are excellent options for metacarpal shaft fractures without significant radiological or clinical problems; however, some clinical outcomes evaluated at least 2 years postoperatively, such as DASH scores and grip strength, were better in the AIN group than in the locking plate group. Plate removal was performed under anesthesia in some patients in the plate group for various reasons, and this may have caused the small differences in the final outcomes evaluated 2 years after surgery.",2019,Mean ROM at the time of hardware removal in these 14 patients was significantly lower compared with the final ROM in groups 1 and 2 (non-removal patients).,"['unstable metacarpal shaft fractures', 'angulated metacarpal shaft fractures', 'mini-open AIN; 40 patients) and the other consecutive patients in group 2 (locking plate; 35 patients) who met our inclusion/exclusion criteria were investigated between January 2010 and December 2016', 'Group 1']","['low-profile locking plate fixation', 'Both mini-open AIN and low-profile plate fixation', 'mini-open antegrade intramedullary nailing (AIN) and open reduction and internal fixation (ORIF) using the low-profile locking plate', 'antegrade intramedullary nailing']","['Extension lag', 'Final grip strengths', 'final VAS scores', 'final angulation measurements', 'DASH scores and grip strength', 'Mean ROM at the time of hardware removal', 'radiological findings (e.g., union and residual angulation or shortening); clinical conditions (e.g., pain, measured on a visual analog scale (VAS), and Disabilities of the Arm, Shoulder, and Hand (DASH) scores); active range of motion (ROM); and grip strength', 'final DASH score']","[{'cui': 'C0443343', 'cui_str': 'Unstable status (qualifier value)'}, {'cui': 'C0025526', 'cui_str': 'Metacarpals'}, {'cui': 'C0337141', 'cui_str': 'Shaft (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0333179', 'cui_str': 'Angulated (qualifier value)'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0677513', 'cui_str': 'Antegrade (qualifier value)'}, {'cui': 'C0021885', 'cui_str': 'Intramedullary Nailing'}, {'cui': 'C2370853', 'cui_str': 'Open reduction (procedure)'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}]","[{'cui': 'C0231746', 'cui_str': 'Extension lag finding'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C1282927', 'cui_str': 'Shortened (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}]",,0.0194732,Mean ROM at the time of hardware removal in these 14 patients was significantly lower compared with the final ROM in groups 1 and 2 (non-removal patients).,"[{'ForeName': 'Soo Min', 'Initials': 'SM', 'LastName': 'Cha', 'Affiliation': 'Department of Orthopedic Surgery, Regional Rheumatoid and Degenerative Arthritis Center, Chungnam National University Hospital, Chungnam National University School of Medicine, 266 Munwha-ro, Jung-Gu, Daejeon, Republic of Korea.'}, {'ForeName': 'Hyun Dae', 'Initials': 'HD', 'LastName': 'Shin', 'Affiliation': 'Department of Orthopedic Surgery, Regional Rheumatoid and Degenerative Arthritis Center, Chungnam National University Hospital, Chungnam National University School of Medicine, 266 Munwha-ro, Jung-Gu, Daejeon, Republic of Korea. Electronic address: hyunsd@cnu.ac.kr.'}, {'ForeName': 'Yun Ki', 'Initials': 'YK', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopedic Surgery, Regional Rheumatoid and Degenerative Arthritis Center, Chungnam National University Hospital, Chungnam National University School of Medicine, 266 Munwha-ro, Jung-Gu, Daejeon, Republic of Korea.'}]",Injury,['10.1016/j.injury.2019.10.018']
1584,31609709,Use of impregnated catheters to decrease colonization rates in neonates - A randomized controlled pilot trial.,"OBJECTIVE


Nosocomial infections increase mortality and morbidity in preterm infants. Central venous line colonization is a major risk factor for the development of such infections. In adults and children, antibiotic and antimycotic impregnated catheters have been demonstrated to reduce colonization. However, recently published data showed no significant difference in bloodstream infection in neonates when an impregnated catheter was used. We investigated the effect of impregnation of percutaneously inserted micro-catheters (PICC) on colonization in preterm and sick term infants in our unit.
METHODS


Neonates were randomly assigned to receive either a standard (S-PICC; n = 34) or antibiotic and antimycotic impregnated (IP-PICC; n = 37) PICC. Catheters were placed and removed according to a standard procedure and subsequently examined by roll-out culture. The primary outcome was the rate of colonization defined as >15 colony-forming-units/ml. Additional outcomes were catheter associated or systemic infections.
RESULTS


The rate of colonization was lower in neonates who received an IP-PICC as compared to S-PICC (5.6% vs. 12.1% respectively; p = 0.42). However, the difference was not significant. In IP-PICC vs S-PICC, catheter related local infection (CRI) although lower was not statistically significant (2.9% vs. 6.1%; p = 0.60). We observed no difference in catheter related systemic infection (CR-SI) (0% vs. 3.1%, p = 0.48). The neonates whose catheters were colonized were predominantly of a lower gestational age (median 254/7, p = 0.05) and males (100%, p = 0.01). In addition, the median colony count in the colonized IP-PICC catheters was lower as compared to S- PICC group (53 vs 250, p = 0.06).
CONCLUSIONS


The use of antibiotic and antimycotic impregnated PICC-lines in neonates tended to decrease colonization rates in neonates in our centers but this difference was not significant. Lower gestational age and male sex are risk factors for catheter colonization.",2020,"In IP-PICC vs S-PICC, catheter related local infection (CRI) although lower was not statistically significant (2.9% vs. 6.1%; p = 0.60).","['preterm and sick term infants in our unit', 'preterm infants', 'Neonates']","['impregnated catheters', 'percutaneously inserted micro-catheters (PICC', 'standard (S-PICC; n\u200a=\u200a34) or antibiotic and antimycotic impregnated (IP-PICC; n\u200a=\u200a37) PICC']","['median colony count', 'catheter associated or systemic infections', 'rate of colonization defined as >15 colony-forming-units/ml', 'rate of colonization', 'bloodstream infection', 'catheter related systemic infection (CR-SI', 'colonization rates']","[{'cui': 'C0456128', 'cui_str': 'Term infant (finding)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}]","[{'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0368993', 'cui_str': 'Colony count'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit (qualifier value)'}, {'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",,0.153808,"In IP-PICC vs S-PICC, catheter related local infection (CRI) although lower was not statistically significant (2.9% vs. 6.1%; p = 0.60).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Klemme', 'Affiliation': ""Division of Neonatology, Dr. v. Hauner Children's Hospital and Perinatal Center Munich - Grosshadern, LMU Munich, Germany.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Staffler', 'Affiliation': 'Division of Neonatology, Central Teaching Hospital of Bolzano/Bozen, Bolzano, Italy.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'De Maio', 'Affiliation': ""Division of Neonatology, Dr. v. Hauner Children's Hospital and Perinatal Center Munich - Grosshadern, LMU Munich, Germany.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lauseker', 'Affiliation': 'Institute for Medical Information Processing, Biometry, and Epidemiology, Ludwig Maximilians University, Munich, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Schubert', 'Affiliation': 'Max von Pettenkofer Institute of Hygiene and Medical Microbiology, Faculty of Medicine, LMU Munich, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Innocenti', 'Affiliation': 'Laboratory of Microbiology and Virology, Bolzano Health District, Bolzano, Italy.'}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'Wurster', 'Affiliation': 'Division of Neonatology, Central Teaching Hospital of Bolzano/Bozen, Bolzano, Italy.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Foerster', 'Affiliation': ""Division of Neonatology, Dr. v. Hauner Children's Hospital and Perinatal Center Munich - Grosshadern, LMU Munich, Germany.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Herber-Jonat', 'Affiliation': ""Division of Neonatology, Dr. v. Hauner Children's Hospital and Perinatal Center Munich - Grosshadern, LMU Munich, Germany.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mittal', 'Affiliation': ""Division of Neonatology, Dr. v. Hauner Children's Hospital and Perinatal Center Munich - Grosshadern, LMU Munich, Germany.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Messner', 'Affiliation': 'Division of Neonatology, Central Teaching Hospital of Bolzano/Bozen, Bolzano, Italy.'}, {'ForeName': 'A W', 'Initials': 'AW', 'LastName': 'Flemmer', 'Affiliation': ""Division of Neonatology, Dr. v. Hauner Children's Hospital and Perinatal Center Munich - Grosshadern, LMU Munich, Germany.""}]",Journal of neonatal-perinatal medicine,['10.3233/NPM-190273']
1585,31609637,"FOLFOXIRI Plus Panitumumab As First-Line Treatment of  RAS  Wild-Type Metastatic Colorectal Cancer: The Randomized, Open-Label, Phase II VOLFI Study (AIO KRK0109).","PURPOSE


This trial investigated the addition of panitumumab to triplet chemotherapy with fluorouracil/folinic acid, oxaliplatin, and irinotecan (FOLFOXIRI) in a two-to-one randomized, controlled, open-label, phase II trial in patients with untreated  RAS  wild-type (WT) metastatic colorectal cancer.
PATIENTS AND METHODS


The primary end point was objective response rate (ORR) according to RECIST (version 1.1). The experimental arm (modified FOLFOXIRI [mFOLFOXIRI] plus panitumumab) was considered active if the ORR was ≥ 75%. The experimental ORR was compared with an estimated ORR of 60% based on historical data, verified by a randomized control group (FOLFOXIRI). The power of the trial was 80%, with a potential type I error of 0.05. Secondary end points included secondary resection rate, toxicity, progression-free survival, and overall survival.
RESULTS


A total of 63 patients were randomly assigned to the experimental arm and 33 patients to the control arm. The ORR of the mFOLFOXIRI plus panitumumab arm exceeded 75% and was higher when compared with that of FOLFOXIRI (87.3%  v  60.6%; odds ratio, 4.469; 95% CI, 1.61 to 12.38;  P  = .004). The secondary resection rate was improved with the addition of panitumumab (33.3%  v  12.1%;  P  = .02). Progression-free survival was similar in the study arms, whereas overall survival showed a trend in favor of the panitumumab-containing arm (hazard ratio for death, 0.67; 95% CI, 0.41 to 1.11;  P  = .12).
CONCLUSION


The addition of panitumumab to mFOLFOXIRI in patients with  RAS  WT metastatic colorectal cancer improved the ORR and rate of secondary resection of metastases and represents a treatment option in selected and fit patients in need of highly active first-line therapy. Future studies should determine whether the addition of panitumumab to mFOLFOXIRI prolongs survival.",2019,"Progression-free survival was similar in the study arms, whereas overall survival showed a trend in favor of the panitumumab-containing arm (hazard ratio for death, 0.67; 95% CI, 0.41 to 1.11;  P  = .12).
","['Wild-Type Metastatic Colorectal Cancer', '63 patients', 'patients with untreated  RAS  wild-type (WT) metastatic colorectal cancer', 'patients with  RAS  WT metastatic colorectal cancer']","['panitumumab to triplet chemotherapy with fluorouracil/folinic acid, oxaliplatin, and irinotecan (FOLFOXIRI', 'FOLFOXIRI Plus Panitumumab', 'panitumumab', 'experimental arm (modified FOLFOXIRI [mFOLFOXIRI] plus panitumumab']","['Progression-free survival', 'overall survival', 'objective response rate (ORR', 'secondary resection rate', 'secondary resection rate, toxicity, progression-free survival, and overall survival']","[{'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0041095', 'cui_str': 'Triplets'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.204724,"Progression-free survival was similar in the study arms, whereas overall survival showed a trend in favor of the panitumumab-containing arm (hazard ratio for death, 0.67; 95% CI, 0.41 to 1.11;  P  = .12).
","[{'ForeName': 'Dominik P', 'Initials': 'DP', 'LastName': 'Modest', 'Affiliation': 'Hospital of the University of Munich, Munich, Germany.'}, {'ForeName': 'Uwe M', 'Initials': 'UM', 'LastName': 'Martens', 'Affiliation': 'Klinik für Innere Medizin III, SLK-Kliniken Heilbronn, Heilbronn, Germany.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Riera-Knorrenschild', 'Affiliation': 'Universitätsklinik Marburg, Marburg, Germany.'}, {'ForeName': 'Jobst', 'Initials': 'J', 'LastName': 'Greeve', 'Affiliation': 'St Vincenz-Krankenhaus Paderborn, Paderborn, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Florschütz', 'Affiliation': 'Stadtisches Klinikum Dessau, Dessau, Germany.'}, {'ForeName': 'Swen', 'Initials': 'S', 'LastName': 'Wessendorf', 'Affiliation': 'Klinikum Esslingen, Esslingen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ettrich', 'Affiliation': 'Universitätsklinikum Ulm, Ulm, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Kanzler', 'Affiliation': 'Leopoldina Krankenhaus, Schweinfurt, Germany.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Nörenberg', 'Affiliation': 'Hospital of the University of Munich, Munich, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Ricke', 'Affiliation': 'Hospital of the University of Munich, Munich, Germany.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Seidensticker', 'Affiliation': 'Hospital of the University of Munich, Munich, Germany.'}, {'ForeName': 'Swantje', 'Initials': 'S', 'LastName': 'Held', 'Affiliation': 'ClinAssess, Leverkusen, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Buechner-Steudel', 'Affiliation': 'Universitätsklinikum Halle (Saale), Halle, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Atzpodien', 'Affiliation': 'Franziskus-Hospital Harderberg, Georgsmarienhütte, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Hospital of the University of Munich, Munich, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Seufferlein', 'Affiliation': 'Universitätsklinikum Ulm, Ulm, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Tannapfel', 'Affiliation': 'Ruhr Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Anke C', 'Initials': 'AC', 'LastName': 'Reinacher-Schick', 'Affiliation': 'St Josef Hospital, Bochum, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Geissler', 'Affiliation': 'Klinikum Esslingen, Esslingen, Germany.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01340']
1586,31851348,Effect of a Computer-Based Decision Support Intervention on Autism Spectrum Disorder Screening in Pediatric Primary Care Clinics: A Cluster Randomized Clinical Trial.,"Importance


Universal early screening for autism spectrum disorder (ASD) is recommended but not routinely performed.
Objective


To determine whether computer-automated screening and clinical decision support can improve ASD screening rates in pediatric primary care practices.
Design, Setting, and Participants


This cluster randomized clinical trial, conducted between November 16, 2010, and November 21, 2012, compared ASD screening rates among a random sample of 274 children aged 18 to 24 months in urban pediatric clinics of an inner-city county hospital system with or without an ASD screening module built into an existing decision support software system. Statistical analyses were conducted from February 6, 2017, to June 1, 2018.
Interventions


Four clinics were matched in pairs based on patient volume and race/ethnicity, then randomized within pairs. Decision support with the Child Health Improvement Through Computer Automation system (CHICA) was integrated with workflow and with the electronic health record in intervention clinics.
Main Outcomes and Measures


The main outcome was screening rates among children aged 18 to 24 months. Because the intervention was discontinued among children aged 18 months at the request of the participating clinics, only results for those aged 24 months were collected and analyzed. Rates of positive screening results, clinicians' response rates to screening results in the computer system, and new cases of ASD identified were also measured. Main results were controlled for race/ethnicity and intracluster correlation.
Results


Two clinics were randomized to receive the intervention, and 2 served as controls. Records from 274 children (101 girls, 162 boys, and 11 missing information on sex; age range, 23-30 months) were reviewed (138 in the intervention clinics and 136 in the control clinics). Of 263 children, 242 (92.0%) were enrolled in Medicaid, 138 (52.5%) were African American, and 96 (36.5%) were Hispanic. Screening rates in the intervention clinics increased from 0% (95% CI, 0%-5.5%) at baseline to 68.4% (13 of 19) (95% CI, 43.4%-87.4%) in 6 months and to 100% (18 of 18) (95% CI, 81.5%-100%) in 24 months. Control clinics had no significant increase in screening rates (baseline, 7 of 64 children [10.9%]; 6-24 months after the intervention, 11 of 72 children [15.3%]; P = .46). Screening results were positive for 265 of 980 children (27.0%) screened by CHICA during the study period. Among the 265 patients with positive screening results, physicians indicated any response in CHICA in 151 (57.0%). Two children in the intervention group received a new diagnosis of ASD within the time frame of the study.
Conclusions and Relevance


The findings suggest that computer automation, when integrated with clinical workflow and the electronic health record, increases screening of children for ASD, but follow-up by physicians is still flawed. Automation of the subsequent workup is still needed.
Trial Registration


ClinicalTrials.gov identifier: NCT01612897.",2019,"Screening rates in the intervention clinics increased from 0% (95% CI, 0%-5.5%) at baseline to 68.4% (13 of 19) (95% CI, 43.4%-87.4%) in 6 months and to 100% (18 of 18) (95% CI, 81.5%-100%) in 24 months.","['November 16, 2010, and November 21, 2012, compared ASD screening rates among a random sample of 274 children aged 18 to 24 months in urban pediatric clinics of an inner-city county hospital system with or without an ASD screening module built into an existing decision support software system', 'Autism', 'Of 263 children, 242 (92.0%) were enrolled in Medicaid, 138 (52.5%) were African American, and 96 (36.5%) were Hispanic', '265 patients with positive screening', '274 children (101 girls, 162 boys, and 11 missing information on sex; age range, 23-30 months) were reviewed (138 in the intervention clinics and 136 in the control clinics', 'Pediatric Primary Care Clinics', 'pediatric primary care practices', 'autism spectrum disorder (ASD', '980 children (27.0%) screened by CHICA during the study period']","['computer-automated screening and clinical decision support', 'Computer-Based Decision Support Intervention', 'Computer Automation system (CHICA']","['Screening rates', 'ASD screening rates', 'screening rates', 'response in CHICA']","[{'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C3839701', 'cui_str': 'Pediatric clinic (environment)'}, {'cui': 'C0557849', 'cui_str': 'Inner city environment (environment)'}, {'cui': 'C0020005', 'cui_str': 'Hospitals, County'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C4517802', 'cui_str': '52.5 (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C4042765', 'cui_str': 'Clinical Decision Support'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0004376', 'cui_str': 'Automation'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0220908', 'cui_str': 'Screening'}]",980.0,0.0813254,"Screening rates in the intervention clinics increased from 0% (95% CI, 0%-5.5%) at baseline to 68.4% (13 of 19) (95% CI, 43.4%-87.4%) in 6 months and to 100% (18 of 18) (95% CI, 81.5%-100%) in 24 months.","[{'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Downs', 'Affiliation': ""Division of Children's Health Services Research, Department of Pediatrics, Indiana University School of Medicine, Indianapolis.""}, {'ForeName': 'Nerissa S', 'Initials': 'NS', 'LastName': 'Bauer', 'Affiliation': 'Axon Health Associates LLC, Indianapolis, Indiana.'}, {'ForeName': 'Chandan', 'Initials': 'C', 'LastName': 'Saha', 'Affiliation': 'Department of Biostatistics, Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Ofner', 'Affiliation': 'Department of Biostatistics, Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'Aaron E', 'Initials': 'AE', 'LastName': 'Carroll', 'Affiliation': 'Regenstrief Institute Inc, Indianapolis, Indiana.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.17676']
1587,31612359,"Analgesic Efficacy, Practicality and Safety of Inhaled Methoxyflurane Versus Standard Analgesic Treatment for Acute Trauma Pain in the Emergency Setting: A Randomised, Open-Label, Active-Controlled, Multicentre Trial in Italy (MEDITA).","INTRODUCTION


Inhaled low-dose methoxyflurane is approved in Europe for emergency relief of moderate-to-severe trauma-related pain in adults, but data versus active comparators are sparse. The phase IIIb Methoxyflurane in Emergency Department in ITAly (MEDITA) trial investigated the analgesic efficacy, practicality and safety of methoxyflurane versus standard analgesic treatment (SAT) for acute trauma pain.
METHODS


This was a randomised, active-controlled, parallel-group, open-label trial conducted in 15 Italian emergency units. Adults with limb trauma and pain score ≥ 4 on numerical rating scale (NRS) were randomised 1:1 to inhaled methoxyflurane 3 mL or SAT [intravenously administered (IV) morphine 0.1 mg/kg for severe pain (NRS ≥ 7); IV paracetamol 1 g or IV ketoprofen 100 mg for moderate pain (NRS 4-6)]. The primary endpoint was overall change in visual analogue scale (VAS) pain intensity from baseline (time of randomisation) to 3, 5 and 10 min. Non-inferiority and superiority of methoxyflurane versus SAT were concluded if the upper 95% confidence interval (CI) for the treatment comparison (methoxyflurane-SAT) was less than 1 and less than 0, respectively.
RESULTS


Between 8 February 2018 and 8 February 2019, 272 patients were randomised (136 per treatment group). A total of 270 patients (mean age 51 years; 49% male; 34% with severe pain; mean baseline VAS 67 mm) were treated and analysed for efficacy and safety. Superiority of methoxyflurane was demonstrated for moderate-to-severe pain (adjusted mean treatment difference - 5.94 mm; 95% CI - 8.83, - 3.06 mm), moderate pain (- 5.97 mm; 95% CI - 9.55, - 2.39 mm) and severe pain (- 5.54 mm; 95% CI - 10.49, - 0.59 mm). Median onset of pain relief was 9 min for methoxyflurane and 15 min for SAT. Practicality of methoxyflurane treatment was rated ""Excellent"", ""Very Good"" or ""Good"" by 90% of clinicians vs. 64% for SAT. Adverse events (all non-serious) were reported by 17% of methoxyflurane-treated patients and 3% of SAT-treated patients.
CONCLUSION


Methoxyflurane provided superior pain relief to SAT in patients with moderate-to-severe trauma pain and may offer a simple, fast, effective non-opioid treatment option.
TRIAL REGISTRATION


Trial registered with EudraCT (2017-001565-25) on 2 March 2018 and ClinicalTrials.gov (NCT03585374) on 13 July 2018.
FUNDING


Mundipharma Pharmaceuticals S.r.l.",2019,"Superiority of methoxyflurane was demonstrated for moderate-to-severe pain (adjusted mean treatment difference - 5.94 mm; 95% CI - 8.83, - 3.06 mm), moderate pain (- 5.97 mm; 95% CI - 9.55, - 2.39 mm) and severe pain (- 5.54 mm; 95% CI - 10.49, - 0.59 mm).","['Acute Trauma Pain in the Emergency Setting', 'Between 8 February 2018 and 8 February 2019, 272 patients', '270 patients (mean age 51\xa0years; 49% male; 34% with severe pain; mean baseline VAS 67\xa0mm', 'acute trauma pain', '15 Italian emergency units', 'patients with moderate-to-severe trauma pain', 'Adults with limb trauma and pain score\u2009≥\u20094 on numerical rating scale (NRS', 'Emergency Department in ITAly', '2017-001565-25) on 2 March 2018 and ClinicalTrials.gov (NCT03585374) on 13 July 2018']","['inhaled methoxyflurane 3\xa0mL or SAT [intravenously administered (IV) morphine 0.1\xa0mg/kg for severe pain (NRS\u2009≥\u20097); IV paracetamol 1\xa0g or IV ketoprofen', 'methoxyflurane versus standard analgesic treatment (SAT', 'Methoxyflurane', 'Inhaled Methoxyflurane Versus Standard Analgesic Treatment', 'methoxyflurane', 'EudraCT']","['overall change in visual analogue scale (VAS) pain intensity from baseline (time of randomisation) to 3, 5 and 10\xa0min. Non-inferiority and superiority of methoxyflurane versus SAT', 'Median onset of pain relief', 'severe pain', 'Analgesic Efficacy, Practicality and Safety', 'efficacy and safety', 'Adverse events', 'moderate pain', 'pain relief', 'moderate-to-severe pain', 'analgesic efficacy, practicality and safety']","[{'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}, {'cui': 'C0337810', 'cui_str': 'Italians (ethnic group)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0222045'}, {'cui': 'C0022277', 'cui_str': 'Italy'}]","[{'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0025688', 'cui_str': 'Methoxyflurane'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0022635', 'cui_str': 'Ketoprofen'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0025688', 'cui_str': 'Methoxyflurane'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0278139', 'cui_str': 'Moderate pain (finding)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",272.0,0.408138,"Superiority of methoxyflurane was demonstrated for moderate-to-severe pain (adjusted mean treatment difference - 5.94 mm; 95% CI - 8.83, - 3.06 mm), moderate pain (- 5.97 mm; 95% CI - 9.55, - 2.39 mm) and severe pain (- 5.54 mm; 95% CI - 10.49, - 0.59 mm).","[{'ForeName': 'Sebastiano', 'Initials': 'S', 'LastName': 'Mercadante', 'Affiliation': 'Main Regional Center for Pain Relief and Supportive/Palliative Care, La Maddalena Cancer Center, Palermo, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Voza', 'Affiliation': 'Emergency Department, IRCCS Humanitas Research Teaching Hospital, Rozzano, Milan, Italy.'}, {'ForeName': 'Sossio', 'Initials': 'S', 'LastName': 'Serra', 'Affiliation': 'Emergency Department, Maurizio Bufalini Hospital, Cesena, Italy.'}, {'ForeName': 'Germana', 'Initials': 'G', 'LastName': 'Ruggiano', 'Affiliation': 'Emergency Medicine Department, Santa Maria Annunziata Hospital, Florence, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Carpinteri', 'Affiliation': 'Department of Emergency Medicine, Policlinico G. Rodolico University Hospital, Catania, Italy.'}, {'ForeName': 'Gianfilippo', 'Initials': 'G', 'LastName': 'Gangitano', 'Affiliation': 'Emergency Department, Infermi Hospital, Rimini, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Intelligente', 'Affiliation': 'Emergency Department, IRCCS Humanitas Research Teaching Hospital, Rozzano, Milan, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Bonafede', 'Affiliation': 'YGHEA, CRO Division of Ecol Studio Bioikos S.r.l., Bologna, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Sblendido', 'Affiliation': 'Medical Affairs Department, Mundipharma Pharmaceuticals S.r.l., Milan, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Farina', 'Affiliation': 'Medical Affairs Department, Mundipharma Pharmaceuticals S.r.l., Milan, Italy.'}, {'ForeName': 'Amedeo', 'Initials': 'A', 'LastName': 'Soldi', 'Affiliation': 'Medical Affairs Department, Mundipharma Pharmaceuticals S.r.l., Milan, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Fabbri', 'Affiliation': 'Department of Emergency Medicine, Morgagni-Pierantoni Hospital, Forlì, Italy. andrea.fabbri@auslromagna.it.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Advances in therapy,['10.1007/s12325-019-01055-9']
1588,29230318,Reducing PTSD symptoms through a gender norms and economic empowerment intervention to reduce intimate partner violence: a randomized controlled pilot study in Côte D'Ivoire.,"Background


Women living in war-affected contexts face high levels of gender-based violence, including intimate partner violence (Stark & Ager, 2011). Despite well-documented negative consequences, including posttraumatic stress disorder (PTSD) (Garcia-Moreno  et al.  2006; Steel  et al.  2009), evidence remains thin regarding intervention effectiveness to mitigate consequences in these settings.
Methods


This study used a two-armed parallel pilot randomized controlled trial to compare the impact of a group savings only (control) to gender dialogue groups added to group savings (treatment) on women's symptoms of PTSD in northwestern Côte d'Ivoire. Eligible Ivorian women (18+ years, no prior experience with group savings) were invited to participate and 1198 were randomized into treatment groups.
Results


In the ITT analyses, women in the treatment arm had significantly fewer PTSD symptoms relative to the control arm ( β : -0.12; 95% CI: -0.20 to -0.03;  p  = 0.005). Partnered women in the treatment arm who had not experienced intimate partner violence (IPV) at baseline had significantly fewer PTSD symptoms than the control arm ( β  = -0.12; 95% CI: -0.21 to -0.03;  p  = 0.008), while those who had experienced IPV did not show significant differences between treatment and control arms ( β  = -0.09; 95% CI: -0.29 to 0.11;  p  = 0.40).
Conclusions


Adding a couples gender discussion group to a women's savings group significantly reduced women's PTSD symptoms overall. Different patterns emerge for women who experienced IPV at baseline  v.  those who did not. More research is needed on interventions to improve mental health symptoms for women with and without IPV experiences in settings affected by conflict.",2017,Partnered women in the treatment arm who had not experienced intimate partner violence (IPV) at baseline had significantly fewer PTSD symptoms than the control arm ( β  ,"[""women's symptoms of PTSD in northwestern Côte d'Ivoire"", 'Eligible Ivorian women (18+ years, no prior experience with group savings']","['economic empowerment intervention', 'group savings only (control) to gender dialogue groups added to group savings (treatment']","['mental health symptoms', ""women's PTSD symptoms overall"", 'intimate partner violence', 'intimate partner violence (IPV', 'PTSD symptoms']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0036245', 'cui_str': 'Savings'}]","[{'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0036245', 'cui_str': 'Savings'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}]",,0.102179,Partnered women in the treatment arm who had not experienced intimate partner violence (IPV) at baseline had significantly fewer PTSD symptoms than the control arm ( β  ,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Annan', 'Affiliation': 'International Rescue Committee, University of Chicago, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Falb', 'Affiliation': 'International Rescue Committee, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kpebo', 'Affiliation': ""Medical School of Abidjan, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hossain', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gupta', 'Affiliation': 'George Mason University, Fairfax, Virginia, USA.'}]","Global mental health (Cambridge, England)",['10.1017/gmh.2017.19']
1589,29230314,Testing the effectiveness of a transdiagnostic treatment approach in reducing violence and alcohol abuse among families in Zambia: study protocol of the Violence and Alcohol Treatment (VATU) trial.,"Background


Violence against women and girls (VAWG) is an urgent global health problem. Root causes for VAWG include the individual- and family-level factors of alcohol abuse, mental health problems, violence exposure, and related adverse experiences. Few studies in low- and middle-income countries (LMIC) have assessed the effectiveness of psychological interventions for reducing VAWG. This randomized controlled trial, part of the  What Works to Prevent Violence Against Women and Girls  consortium, examines the effectiveness of a common elements treatment approach (CETA) for reducing VAWG and comorbid alcohol abuse among families in Zambia.
Methods/design


Study participants are families consisting of three persons: an adult woman, her male husband or partner, and one of her children aged 8-17 (if available). Eligibility criteria include experience of moderate-to-severe intimate partner violence by the woman and hazardous alcohol use by her male partner. Family units are randomized to receive CETA or treatment as usual. The primary outcome is VAWG as measured by the Severity of Violence Against Women Scale, assessed along with secondary outcomes at 24 months post-baseline. Interim assessments are also conducted at 4-5 months (following CETA completion) and 12 months post-baseline.
Conclusions


This ongoing trial is one of the first in sub-Saharan Africa to evaluate the use of an evidence-based common elements approach for reducing VAWG by targeting a range of individual- and family-level factors, including alcohol abuse. Results of this trial will inform policy on what interventions work to prevent VAWG in LMIC with local perspectives on scale up and wider implementation.",2017,Few studies in low- and middle-income countries (LMIC) have assessed the effectiveness of psychological interventions for reducing VAWG.,"['Eligibility criteria include experience of moderate-to-severe intimate partner violence by the woman and hazardous alcohol use by her male partner', 'Violence Against Women and Girls  consortium', 'participants are families consisting of three persons: an adult woman, her male husband or partner, and one of her children aged 8-17 (if available', 'violence and alcohol abuse among families in Zambia', 'VAWG and comorbid alcohol abuse among families in Zambia', '\n\n\nViolence against women and girls (VAWG']","['CETA', 'transdiagnostic treatment approach']",['VAWG as measured by the Severity of Violence Against Women Scale'],"[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0242664', 'cui_str': 'Husband (person)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0085762', 'cui_str': 'Alcohol abuse (disorder)'}, {'cui': 'C0043445', 'cui_str': 'Republic of Zambia'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0222045'}]",,0.104007,Few studies in low- and middle-income countries (LMIC) have assessed the effectiveness of psychological interventions for reducing VAWG.,"[{'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Kane', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, 624 North Broadway, Room 850, Baltimore, MD 21205, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Skavenski Van Wyk', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, 624 North Broadway, Room 850, Baltimore, MD 21205, USA.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Murray', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, 624 North Broadway, Room 850, Baltimore, MD 21205, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bolton', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, 624 North Broadway, Room 850, Baltimore, MD 21205, USA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Melendez', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, 624 North Broadway, Room 850, Baltimore, MD 21205, USA.'}, {'ForeName': 'C K', 'Initials': 'CK', 'LastName': 'Danielson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 67 President St, Charleston, SC 29425, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Chimponda', 'Affiliation': 'Serenity Harm Reduction Programme Zambia (SHARPZ), Plot # 220C, Mutandwa Road, Roma, Lusaka, PO Box 33705, Zambia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Munthali', 'Affiliation': 'Serenity Harm Reduction Programme Zambia (SHARPZ), Plot # 220C, Mutandwa Road, Roma, Lusaka, PO Box 33705, Zambia.'}, {'ForeName': 'L K', 'Initials': 'LK', 'LastName': 'Murray', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, 624 North Broadway, Room 850, Baltimore, MD 21205, USA.'}]","Global mental health (Cambridge, England)",['10.1017/gmh.2017.10']
1590,31851256,Effect of nursing telemonitoring on the knowledge of obese women: clinical trial.,"OBJECTIVE


To assess the effectiveness of remote monitoring in the knowledge of overweight women.
METHOD


Randomized clinical trial with 101 women, randomly assigned to the control group (CG=50) and to the intervention group (IG=51). The IG received educational intervention over the telephone, during three months and routine follow-up in the service, while the CG only received conventional follow-up. The knowledge was assessed by a specific questionnaire. Data were analyzed by the Robust Linear Regression Model, adopting a statistical significance of 5%.
RESULTS


In the intragroup assessment, an increase in the correct answers with a statistically significant difference was observed only for the IG in the domains: ""Concept and causes of overweight,"" ""Complications of overweight"" and ""Eating habits."" In the intergroup comparison, an increase in the average knowledge was verified in the same domains for the IG (p≤0.005).
CONCLUSION


nursing telemonitoring contributed positively to the improvement of women's knowledge.",2019,"In the intragroup assessment, an increase in the correct answers with a statistically significant difference was observed only for the IG in the domains:","['overweight women', 'obese women', '101 women']","['educational intervention', 'nursing telemonitoring']",['average knowledge'],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0028678', 'cui_str': 'nursing care'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}]",101.0,0.0280187,"In the intragroup assessment, an increase in the correct answers with a statistically significant difference was observed only for the IG in the domains:","[{'ForeName': 'Fernanda Carneiro', 'Initials': 'FC', 'LastName': 'Mussi', 'Affiliation': 'Universidade Federal da Bahia. Salvador, Bahia, Brazil.'}, {'ForeName': 'Catia Suely', 'Initials': 'CS', 'LastName': 'Palmeira', 'Affiliation': 'Universidade Federal da Bahia. Salvador, Bahia, Brazil.'}, {'ForeName': 'Carlos Antonio de Souza Teles', 'Initials': 'CAST', 'LastName': 'Santos', 'Affiliation': 'Centro de Pesquisas Goncalo Moniz-FIOCRUZ/SSA, Laboratorio de Epidemiologia Molecular e Bioestatistica . Salvador, Bahia, Brazil.'}, {'ForeName': 'Armenio Costa', 'Initials': 'AC', 'LastName': 'Guimarães', 'Affiliation': 'Escola Baiana de Medicina e Saúde Pública. Salvador, Bahia, Brazil.'}, {'ForeName': 'Maria de Lourdes', 'Initials': 'ML', 'LastName': 'Lima', 'Affiliation': 'Escola Baiana de Medicina e Saúde Pública. Salvador, Bahia, Brazil.'}, {'ForeName': 'Taise Santos do', 'Initials': 'TSD', 'LastName': 'Nascimento', 'Affiliation': 'Universidade Federal da Bahia. Salvador, Bahia, Brazil.'}]",Revista brasileira de enfermagem,['10.1590/0034-7167-2018-0500']
1591,24476560,Impacts of the Primary School Free Breakfast Initiative on socio-economic inequalities in breakfast consumption among 9-11-year-old schoolchildren in Wales.,"OBJECTIVES


Universal interventions may widen or narrow inequalities if disproportionately effective among higher or lower socio-economic groups. The present paper examines impacts of the Primary School Free Breakfast Initiative in Wales on inequalities in children's dietary behaviours and cognitive functioning.
DESIGN


Cluster-randomised controlled trial. Responses were linked to free school meal (FSM) entitlement via the Secure Anonymised Information Linkage databank. Impacts on inequalities were evaluated using weighted school-level regression models with interaction terms for intervention × whole-school percentage FSM entitlement and intervention × aggregated individual FSM entitlement. Individual-level regression models included interaction terms for intervention × individual FSM entitlement.
SETTING


Fifty-five intervention and fifty-six wait-list control primary schools.
SUBJECTS


Approximately 4500 children completed measures of dietary behaviours and cognitive tests at baseline and 12-month follow-up.
RESULTS


School-level models indicated that children in intervention schools ate a greater number of healthy items for breakfast than children in control schools (b = 0·25; 95 % CI 0·07, 0·44), with larger increases observed in more deprived schools (interaction term b = 1·76; 95 % CI 0·36, 3·16). An interaction between intervention and household-level deprivation was not significant. Despite no main effects on breakfast skipping, a significant interaction was observed, indicating declines in breakfast skipping in more deprived schools (interaction term b = -0·07; 95 % CI -0·15, -0·00) and households (OR = 0·67; 95 % CI 0·46, 0·98). No significant influence on inequality was observed for the remaining outcomes.
CONCLUSIONS


Universal breakfast provision may reduce socio-economic inequalities in consumption of healthy breakfast items and breakfast skipping. There was no evidence of intervention-generated inequalities in any outcomes.",2014,"Despite no main effects on breakfast skipping, a significant interaction was observed, indicating declines in breakfast skipping in more deprived schools (interaction term b = -0·07; 95 % CI -0·15, -0·00) and households (OR = 0·67; 95 % CI 0·46, 0·98).","['breakfast consumption among 9-11-year-old schoolchildren in Wales', 'Fifty-five intervention and fifty-six wait-list control primary schools', 'Approximately 4500 children', ""children's dietary behaviours and cognitive functioning""]",['Primary School Free Breakfast Initiative'],"['number of healthy items', 'breakfast skipping', 'dietary behaviours and cognitive tests', 'inequality']","[{'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C4517780', 'cui_str': 'Four thousand five hundred'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0242503', 'cui_str': 'Inequalities'}]",4500.0,0.0248185,"Despite no main effects on breakfast skipping, a significant interaction was observed, indicating declines in breakfast skipping in more deprived schools (interaction term b = -0·07; 95 % CI -0·15, -0·00) and households (OR = 0·67; 95 % CI 0·46, 0·98).","[{'ForeName': 'Graham F', 'Initials': 'GF', 'LastName': 'Moore', 'Affiliation': '1 DECIPHer, School of Social Sciences, Cardiff University, 1-3 Museum Place, Cardiff CF10 3BD, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Murphy', 'Affiliation': '1 DECIPHer, School of Social Sciences, Cardiff University, 1-3 Museum Place, Cardiff CF10 3BD, UK.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Chaplin', 'Affiliation': '2 School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'Ronan A', 'Initials': 'RA', 'LastName': 'Lyons', 'Affiliation': '3 Health Information Research Unit, College of Medicine, Swansea University, Swansea, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Atkinson', 'Affiliation': '3 Health Information Research Unit, College of Medicine, Swansea University, Swansea, UK.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Moore', 'Affiliation': '1 DECIPHer, School of Social Sciences, Cardiff University, 1-3 Museum Place, Cardiff CF10 3BD, UK.'}]",Public health nutrition,['10.1017/S1368980013003133']
1592,31603205,Supplementation with Small-Quantity Lipid-Based Nutrient Supplements Does Not Increase Child Morbidity in a Semiurban Setting in Ghana: A Secondary Outcome Noninferiority Analysis of the International Lipid-Based Nutrient Supplements (iLiNS)-DYAD Randomized Controlled Trial.,"BACKGROUND


Adequate knowledge about the safety of consumption of small-quantity lipid-based nutrient supplements (SQ-LNSs) is needed.
OBJECTIVE


We aimed to test the hypothesis that SQ-LNS consumption is noninferior to control with respect to child morbidity.
METHODS


Women (n = 1320) ≤20 wk pregnant were assigned to iron and folic acid until delivery with no supplementation for offspring; or multiple micronutrient supplements until 6 mo postpartum with no supplementation for offspring; or SQ-LNSs until 6 mo postpartum, and SQ-LNSs for offspring (6 mg Fe/d) from 6 to 18 mo of age [the lipid-based nutrient supplement (LNS) group]. We assessed noninferiority (margin ≤20%) between any 2 groups during 0-6 mo of age, and between the non-LNS and LNS groups during 6-18 mo of age for caregiver-reported acute respiratory infection, diarrhea, gastroenteritis, fever/suspected malaria, poor appetite, and ""other illnesses.""
RESULTS


During 0-6 mo of age, 1197 infants contributed 190,503 infant-days. For all morbidity combined, overall mean incidence (per 100 infant-days) was 3.3 episodes, overall mean prevalence (percentage of infant-days) was 19.3%, and the 95% CIs of the incidence rate ratio (IRR) and longitudinal prevalence rate ratio (LPRR) between any 2 groups were ≤1.20. During 6-18 mo, there were 240,097 infant-days for the non-LNS group and 118,698 for the LNS group. For all morbidity combined, group mean incidences were 4.3 and 4.3, respectively (IRR: 1.0; 95% CI: 1.0, 1.1), and mean prevalences were 28.2% and 29.3%, respectively (LPRR: 1.0; 95% CI: 1.0, 1.1). Noninferiority was inconclusive for diarrhea, fever/suspected malaria, and poor appetite.
CONCLUSIONS


SQ-LNS consumption does not increase reported overall child morbidity in this population compared with the 2 other treatments.This trial was registered at clinicaltrials.gov as NCT00970866.",2020,"For all morbidity combined, group mean incidences were 4.3 and 4.3, respectively","['Semiurban Setting in Ghana', '1197 infants contributed 190,503 infant-days', '1320)\xa0≤20 wk pregnant', 'Women (n\xa0']","['iron and folic acid until delivery with no supplementation for offspring; or multiple micronutrient supplements until 6\xa0mo postpartum with no supplementation for offspring; or SQ-LNSs until 6\xa0mo postpartum, and SQ-LNSs for offspring (6\xa0mg Fe/d) from 6 to 18\xa0mo of age [the lipid-based nutrient supplement (LNS', 'Supplementation with Small-Quantity Lipid-Based Nutrient Supplements']","['diarrhea, fever/suspected malaria, and poor appetite', 'acute respiratory infection, diarrhea, gastroenteritis, fever/suspected malaria, poor appetite, and ""other illnesses', 'Child Morbidity', 'mean prevalences', 'incidence rate ratio (IRR) and longitudinal prevalence rate ratio (LPRR', 'overall child morbidity', 'overall mean incidence']","[{'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0017516', 'cui_str': 'Republic of Ghana'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite (finding)'}, {'cui': 'C0339901', 'cui_str': 'ARI - Acute respiratory infections'}, {'cui': 'C0017160', 'cui_str': 'Gastroenteritis'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",1197.0,0.445583,"For all morbidity combined, group mean incidences were 4.3 and 4.3, respectively","[{'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Adu-Afarwuah', 'Affiliation': 'Department of Nutrition and Food Science, University of Ghana, Legon, Accra, Ghana.'}, {'ForeName': 'Rebecca R', 'Initials': 'RR', 'LastName': 'Young', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lartey', 'Affiliation': 'Department of Nutrition and Food Science, University of Ghana, Legon, Accra, Ghana.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Okronipa', 'Affiliation': 'Department of Nutrition and Food Science, University of Ghana, Legon, Accra, Ghana.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ashorn', 'Affiliation': 'Centre for Child Health Research, Tampere University Faculty of Medicine and Health Sciences and Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Ashorn', 'Affiliation': 'Centre for Child Health Research, Tampere University Faculty of Medicine and Health Sciences and Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Brietta M', 'Initials': 'BM', 'LastName': 'Oaks', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Kathryn G', 'Initials': 'KG', 'LastName': 'Dewey', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxz243']
1593,31605113,Safety and Immunogenicity of the Respiratory Syncytial Virus Vaccine RSV/ΔNS2/Δ1313/I1314L in RSV-Seronegative Children.,"BACKGROUND


Respiratory syncytial virus (RSV) is the leading global cause of severe pediatric acute respiratory tract illness, and a vaccine is needed. RSV/ΔNS2/Δ1313/I1314L contains 2 attenuating elements: (1) deletion of the interferon antagonist NS2 gene and (2) deletion of codon 1313 of the RSV polymerase gene and the stabilizing missense mutation I1314L. This live vaccine candidate was temperature-sensitive, genetically stable, replication restricted, and immunogenic in nonhuman primates.
METHODS


A single intranasal dose of RSV/ΔNS2/Δ1313/I1314L was evaluated in a double-blind, placebo-controlled trial (vaccine-placebo ratio, 2:1) at 106 plaque-forming units (PFU) in 15 RSV-seropositive children and at 105 and 106 PFU in 21 and 30 RSV-seronegative children, respectively.
RESULTS


In RSV-seronegative children, the 105 PFU dose was overattenuated, but the 106 PFU dose was well tolerated, infectious (RSV/ΔNS2/Δ1313/I1314L replication detected in 90% of vaccinees), and immunogenic (geometric mean serum RSV plaque-reduction neutralizing antibody titer, 1:64). After the RSV season, 9 of 20 vaccinees had increases in the RSV titer that were significantly greater than those in 8 of 10 placebo recipients (1:955 vs 1:69, respectively), indicating that the vaccine primed for anamnestic responses after natural RSV exposure.
CONCLUSION


Rational design yielded a genetically stable candidate RSV vaccine that is attenuated yet immunogenic in RSV-seronegative children, warranting further evaluation.
CLINICAL TRIALS REGISTRATION


NCT01893554.",2020,"Rational design yielded a genetically stable candidate RSV vaccine that is attenuated yet immunogenic in RSV-seronegative children, warranting further evaluation.
","['RSV-Seronegative Children', '15 RSV-seropositive children and at 105 and 106 PFU in 21 and 30 RSV-seronegative children, respectively']","['RSV/ΔNS2/Δ1313/I1314L', 'Respiratory Syncytial Virus Vaccine RSV/ΔNS2/Δ1313/I1314L', 'placebo-controlled trial (vaccine-placebo ratio, 2:1) at 106 plaque-forming units (PFU']","['Safety and Immunogenicity', 'RSV titer', 'tolerated, infectious (RSV/ΔNS2/Δ1313/I1314L replication']","[{'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C0521144', 'cui_str': 'Seronegative (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0521143', 'cui_str': 'Seropositive (qualifier value)'}, {'cui': 'C4319547', 'cui_str': '105'}]","[{'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C0887894', 'cui_str': 'RSV Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C0475208', 'cui_str': 'TITR'}]",1313.0,0.354045,"Rational design yielded a genetically stable candidate RSV vaccine that is attenuated yet immunogenic in RSV-seronegative children, warranting further evaluation.
","[{'ForeName': 'Ruth A', 'Initials': 'RA', 'LastName': 'Karron', 'Affiliation': 'Center for Immunization Research, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Luongo', 'Affiliation': 'RNA Viruses Section, Laboratory of Infectious Diseases, National Institute of Allergy, Immunology, and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Jocelyn San', 'Initials': 'JS', 'LastName': 'Mateo', 'Affiliation': 'Center for Immunization Research, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore.'}, {'ForeName': 'Kimberli', 'Initials': 'K', 'LastName': 'Wanionek', 'Affiliation': 'Center for Immunization Research, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore.'}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Collins', 'Affiliation': 'RNA Viruses Section, Laboratory of Infectious Diseases, National Institute of Allergy, Immunology, and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Ursula J', 'Initials': 'UJ', 'LastName': 'Buchholz', 'Affiliation': 'RNA Viruses Section, Laboratory of Infectious Diseases, National Institute of Allergy, Immunology, and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}]",The Journal of infectious diseases,['10.1093/infdis/jiz408']
1594,29061910,Health Coaching in Severe COPD After a Hospitalization: A Qualitative Analysis of a Large Randomized Study.,"BACKGROUND


We recently demonstrated in a randomized study the feasibility and effectiveness of telephone-based health coaching using motivational interviewing on decreasing hospital readmissions and improving quality of life at 6 and 12 months after hospital discharge. In this qualitative study, we sought to explore the health-coaching intervention as seen from the perspective of the participants who received the intervention and the coaches who delivered it.
METHODS


Semistructured participant interviews ( n  = 24) and a focus group of all health coaches ( n  = 3) who participated in this study were conducted. Interviews and focus group were recorded and transcribed verbatim. Transcripts were analyzed using coding and categorizing techniques and thematic analysis. Mixed-method triangulation was used to merge quantitative and qualitative data.
RESULTS


Content analysis revealed 4 predominant themes of the coaching intervention: health-coaching relationship, higher participant confidence and reassurance (most related to improvement in physical quality of life), improved health-care system access (most related to decreased hospital readmissions), and increased awareness of COPD symptoms (most related to improvement in emotional quality of life). The strongest theme was the relationship with the health coach, including coach style and motivational interviewing approach. Health coaches' focus group also noted the importance of the coaching relationship as the most significant theme.
CONCLUSIONS


This study provided themes to further inform the delivery and implementation of health-coaching interventions in patients with COPD after hospital discharge. Health coaching forged partnerships and created a platform for patient engagement, which was confirmed by both participants and health coaches.",2017,"Health coaching forged partnerships and created a platform for patient engagement, which was confirmed by both participants and health coaches.","['participants who received the intervention and the coaches who delivered it', 'Semistructured participant interviews ( n  = 24) and a focus group of all health coaches ( n  = 3) who participated in this study were conducted', 'at 6 and 12 months after hospital discharge', 'Severe COPD', 'patients with COPD after hospital discharge']","['health-coaching intervention', 'Health Coaching', 'telephone-based health coaching using motivational interviewing']","['hospital readmissions and improving quality of life', 'physical quality of life), improved health-care system access', 'awareness of COPD symptoms', 'emotional quality of life']","[{'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C2317129', 'cui_str': 'Health coach'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C2317129', 'cui_str': 'Health coach'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}]","[{'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}]",,0.0376267,"Health coaching forged partnerships and created a platform for patient engagement, which was confirmed by both participants and health coaches.","[{'ForeName': 'Roberto P', 'Initials': 'RP', 'LastName': 'Benzo', 'Affiliation': 'Mindful Breathing Laboratory, Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, Minnesota. benzo.roberto@mayo.edu.'}, {'ForeName': 'Janae L', 'Initials': 'JL', 'LastName': 'Kirsch', 'Affiliation': 'Mindful Breathing Laboratory, Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Julie C', 'Initials': 'JC', 'LastName': 'Hathaway', 'Affiliation': 'Section of Patient Education, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Charlene E', 'Initials': 'CE', 'LastName': 'McEvoy', 'Affiliation': 'HealthPartners Institute for Education and Research, Bloomington, Minnesota.'}, {'ForeName': 'Kristin S', 'Initials': 'KS', 'LastName': 'Vickers', 'Affiliation': 'Division of Psychiatry and Psychology, Mayo Clinic, Rochester, Minnesota.'}]",Respiratory care,['10.4187/respcare.05574']
1595,29183947,Total workload and recovery in relation to worktime reduction: a randomised controlled intervention study with time-use data.,"OBJECTIVES


A 25% reduction of weekly work hours for full-time employees has been shown to improve sleep and alertness and reduce stress during both workdays and days off. The aim of the present study was to investigate how employees use their time during such an intervention: does total workload (paid and non-paid work) decrease, and recovery time increase, when work hours are reduced?
METHODS


Full-time employees within the public sector (n=636; 75% women) were randomised into intervention group and control group. The intervention group (n=370) reduced worktime to 75% with preserved salary during 18 months. Data were collected at baseline, after 9 months and 18 months. Time-use was reported every half-hour daily between 06:00 and 01:00 during 1 week at each data collection. Data were analysed with multilevel mixed modelling.
RESULTS


Compared with the control group, the intervention group increased the time spent on domestic work and relaxing hobby activities during workdays when worktime was reduced (P≤0.001). On days off, more time was spent in free-time activities (P=0.003). Total workload decreased (-65 min) and time spent in recovery activities increased on workdays (+53 min). The pattern of findings was similar in subgroups defined by gender, family status and job situation.
CONCLUSIONS


A worktime reduction of 25% for full-time workers resulted in decreased total workload and an increase of time spent in recovery activities, which is in line with the suggestion that worktime reduction may be beneficial for long-term health and stress.",2018,"A worktime reduction of 25% for full-time workers resulted in decreased total workload and an increase of time spent in recovery activities, which is in line with the suggestion that worktime reduction may be beneficial for long-term health and stress.",['Full-time employees within the public sector (n=636; 75% women'],[],"['Total workload decreased (-65\u2009min) and time spent in recovery activities', 'sleep and alertness and reduce stress', 'free-time activities', 'total workload', 'time spent on domestic work and relaxing hobby activities', 'Total workload and recovery in relation to worktime reduction', 'time spent in recovery activities']","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0034035', 'cui_str': 'Public Sector'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0542193', 'cui_str': 'Relaxed (qualifier value)'}, {'cui': 'C0019826', 'cui_str': 'Hobbies'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.0278425,"A worktime reduction of 25% for full-time workers resulted in decreased total workload and an increase of time spent in recovery activities, which is in line with the suggestion that worktime reduction may be beneficial for long-term health and stress.","[{'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Schiller', 'Affiliation': 'Stress Research Institute, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Lekander', 'Affiliation': 'Stress Research Institute, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Kristiina', 'Initials': 'K', 'LastName': 'Rajaleid', 'Affiliation': 'Stress Research Institute, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Hellgren', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Torbjörn', 'Initials': 'T', 'LastName': 'Åkerstedt', 'Affiliation': 'Stress Research Institute, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Barck-Holst', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Göran', 'Initials': 'G', 'LastName': 'Kecklund', 'Affiliation': 'Stress Research Institute, Stockholm University, Stockholm, Sweden.'}]",Occupational and environmental medicine,['10.1136/oemed-2017-104592']
1596,30541065,Effect of Losartan and Fish Oil on Plasma IL-6 and Mobility in Older Persons. The ENRGISE Pilot Randomized Clinical Trial.,"BACKGROUND


Low-grade chronic inflammation, characterized by elevations in plasma Interleukin-6 (IL-6), is an independent risk factor of impaired mobility in older persons. Angiotensin receptor blockers and omega-3 polyunsaturated fatty acids (ω-3) may reduce IL-6 and may potentially improve physical function. To assess the main effects of the angiotensin receptor blocker losartan and ω-3 as fish oil on IL-6 and 400 m walking speed, we conducted the ENRGISE Pilot multicenter randomized clinical trial.
METHODS


The ENRGISE Pilot enrolled participants between April 2016 and June 2017, who participated for 12 months. Participants were aged ≥70 years with mobility impairment, had IL-6 between 2.5 and 30 pg/mL, and were able to walk 400 m at baseline. Participants were randomized in three strata 2 × 2 factorial to: (i) losartan 50-100 mg/d or placebo (n = 43), (ii) fish oil 1,400-2,800 mg/d or placebo (n = 180), and (iii) with both (n = 66).
RESULTS


Two hundred eighty-nine participants were randomized (mean age 78.3 years, 47.4% women, 17.0% black). There was no effect of losartan (difference of means = -0.065 ± 0.116 [SE], 95% confidence interval [CI]: -0.293-0.163, p = .58) or fish oil (-0.020 ± 0.077, 95% CI: -0.171-0.132, p = .80) on the log of IL-6. Similarly, there was no effect of losartan (-0.025 ± 0.026, 95% CI: -0.076-0.026, p = .34) or fish oil (0.010 ± 0.017, 95% CI: -0.025-0.044, p = .58) on walking speed (m/s).
CONCLUSIONS


These results do not support the use of these interventions to prevent mobility loss in older adults at risk of disability with low-grade chronic inflammation.
REGISTRATION


Clinicaltrials.gov NCT02676466.",2019,"There was no effect of losartan (difference of means=-0.065±0.116 [SE], 95% CI: -0.293 to 0.163, P=0.58) or fish oil (","['older adults at risk of disability with low-grade chronic inflammation', 'Participants were aged >=70 years with mobility impairment, had IL-6 between 2.5 and 30 pg/ml, and were able to walk 400 meters at baseline', 'older persons', '289 participants were randomized (mean ag/e 78.3 years, 47.4% women, 17.0% black', 'Pilot enrolled participants between April 2016 and June 2017, who participated for 12 months']","['losartan and fish oil', 'losartan', 'Angiotensin receptor blockers and omega-3 polyunsaturated fatty acids (ω-3', 'losartan 50 to 100 mg/day or placebo', 'angiotensin receptor blocker losartan', 'fish oil ', 'fish oil 1400 to 2800 mg/day or placebo']","['plasma IL-6 and mobility', 'log of IL-6', 'mobility loss']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0021376', 'cui_str': 'Chronic inflammatory reaction'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439297', 'cui_str': 'pg/mL'}, {'cui': 'C2712089', 'cui_str': 'Able to walk (finding)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor (substance)'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0815017', 'cui_str': 'Angiotensin Receptor Blockers'}, {'cui': 'C4517680', 'cui_str': 'Two thousand eight hundred'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}]",289.0,0.700689,"There was no effect of losartan (difference of means=-0.065±0.116 [SE], 95% CI: -0.293 to 0.163, P=0.58) or fish oil (","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pahor', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Anton', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Beavers', 'Affiliation': 'Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Cauley', 'Affiliation': 'Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Fielding', 'Affiliation': 'Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, Massachusetts.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Kritchevsky', 'Affiliation': 'Department of Internal Medicine, Section of Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Christiaan', 'Initials': 'C', 'LastName': 'Leeuwenburgh', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville.'}, {'ForeName': 'Kristina H', 'Initials': 'KH', 'LastName': 'Lewis', 'Affiliation': 'Departments of Epidemiology & Prevention, and Implementation Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Christine K', 'Initials': 'CK', 'LastName': 'Liu', 'Affiliation': 'Section of Geriatrics, Department of Medicine, Boston University School of Medicine, Massachusetts.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Lovato', 'Affiliation': 'Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Manini', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'McDermott', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Miller', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville.'}, {'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Newman', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Radziszewska', 'Affiliation': 'Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, Maryland.'}, {'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Stowe', 'Affiliation': 'Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Russell P', 'Initials': 'RP', 'LastName': 'Tracy', 'Affiliation': 'Departments of Pathology & Laboratory Medicine, and Biochemistry, Larner College of Medicine, University of Vermont, Burlington.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Walkup', 'Affiliation': 'Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Samuel S', 'Initials': 'SS', 'LastName': 'Wu', 'Affiliation': 'Department of Biostatistics, University of Florida, Gainesville.'}, {'ForeName': 'Walter T', 'Initials': 'WT', 'LastName': 'Ambrosius', 'Affiliation': 'Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/gly277']
1597,31862147,"Use of professional-mode flash glucose monitoring, at 3-month intervals, in adults with type 2 diabetes in general practice (GP-OSMOTIC): a pragmatic, open-label, 12-month, randomised controlled trial.","BACKGROUND


Continuous glucose monitoring, either real-time (personal) or retrospective (professional mode), can identify day-to-day glucose profiles to guide management decisions for people with type 2 diabetes. We aimed to examine the effects of professional-mode flash glucose monitoring, done at 3-month intervals, in adults with type 2 diabetes in general practice.
METHODS


We did a pragmatic, two-arm, open label, 12-month, individually randomised controlled trial (GP-OSMOTIC) in 25 general practices in Victoria, Australia. Eligible participants were adults aged 18-80 years, with type 2 diabetes diagnosed for at least 1 year and HbA 1c  at least 5·5 mmol/mol (0·5%) above their target in the past month despite being prescribed at least two non-insulin glucose-lowering drugs, insulin, or both (with therapy stable for at least 4 months). We randomly assigned participants (1:1) to either use of a professional-mode flash glucose monitoring system or usual clinical care (control). All participants wore the flash glucose monitoring sensor at baseline, and electronic randomisation (using permuted block sizes of four and six, and stratified by clinic) was done after the sensor was attached. Masking of participants and treating clinicians to group allocation was not possible, but the study statistician was masked to allocation when analysing the data. At baseline, and 3, 6, 9, and 12 months, participants in the flash glucose monitoring group wore the professional-mode flash glucose monitoring sensor for 5-14 days before their general practice visit. The sensor recorded interstitial glucose concentrations every 15 min, but the glucose data were not available to the participant until their general practice visit, where the sensor output would be uploaded to a computer by the health professional and discussed. Control group participants wore the sensor at baseline and at 12 months for data analysis only, and had usual care visits every 3 months. The primary outcome was the between-group difference in mean HbA 1c  at 12 months. Secondary outcomes were the between-group differences in: mean percentage time in target glucose range (4-10 mmol/L), based on ambulatory glucose profile data at 12 months; mean diabetes-specific distress (assessed with the Problem Areas In Diabetes [PAID] scale) at 12 months; and mean HbA 1c  at 6 months. Analysis was done by intention to treat. This trial is registered at the Australian and New Zealand Clinical Trials Registry, ACTRN12616001372471.
FINDINGS


Between Oct 4, 2016, and Nov 17, 2017, we randomly assigned 299 adults: 149 to flash glucose monitoring and 150 to usual care. At 6 months, HbA 1c  was lower in the flash glucose monitoring group than in the usual care group (difference -0·5%, 95% CI -0·8% to -0·3%; p=0·0001). However, at 12 months (primary outcome), there was no significant between-group difference in estimated mean HbA 1c  (8·2% [95% CI 8·0 to 8·4] for flash glucose monitoring vs 8·5% [8·3 to 8·7] for usual care; between-group difference -0·3%, 95% CI -0·5 to 0·01; [66 mmol/mol, 95% CI 64 to 68 vs 69 mmol/mol, 67 to 72; between-group difference -3·0, 95% CI -5·0 to 0·1]; p=0·059). Mean percentage time spent in target glucose range at 12 months was 7·9% (95% CI 2·3 to 13·5) higher in the flash glucose monitoring group than in the usual care group (p=0·0060). Diabetes-specific distress PAID scores were unchanged at 12 months (between-group difference -0·7, 95% CI -3·3 to 1·9; p=0·61). No episodes of severe hypoglycaemia or treatment-related deaths were reported. One participant died during the study from causes unrelated to the intervention (following complications post-myocardial infarction with multiple comorbidities).
INTERPRETATION


Professional-mode flash glucose monitoring in adults with type 2 diabetes in general practice did not improve the primary outcome of HbA 1c  at 12 months or diabetes-specific distress compared with usual care, but did improve time in target glucose range at 12 months and HbA 1c  at 6 months. Our findings suggest that professional-mode flash glucose monitoring can be implemented in a pragmatic primary care environment. Although there was no change in HbA 1c  at 12 months, the improved time in target range might reflect the potential of the technology to support personalised clinical care by providing insights into glycaemic profiles for some people with type 2 diabetes.
FUNDING


National Health and Medical Research Council of Australia, Sanofi Australia, and Abbott Diabetes Care.",2020,Diabetes-specific distress PAID scores were unchanged at 12 months (between-group difference,"['adults with type 2 diabetes in general practice (GP-OSMOTIC', 'adults with type 2 diabetes in general practice', '25 general practices in Victoria, Australia', 'Eligible participants were adults aged 18-80 years, with type 2 diabetes diagnosed for at least 1 year and HbA 1c  at least 5·5 mmol/mol (0·5%) above their target in the past month despite being prescribed at least two non-insulin glucose-lowering drugs, insulin, or both (with therapy stable for at least 4 months', 'people with type 2 diabetes']","['professional-mode flash glucose monitoring', 'flash glucose monitoring and 150 to usual care', 'professional-mode flash glucose monitoring system or usual clinical care (control', 'flash glucose monitoring group wore the professional-mode flash glucose monitoring sensor']","['estimated mean HbA 1c', 'severe hypoglycaemia or treatment-related deaths', 'mean percentage time in target glucose range (4-10 mmol/L), based on ambulatory glucose profile data at 12 months; mean diabetes-specific distress', 'HbA 1c', 'flash glucose monitoring', 'Diabetes-specific distress PAID scores', 'time in target glucose range', 'flash glucose monitoring sensor', 'Mean percentage time spent in target glucose range']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}]","[{'cui': 'C0344323', 'cui_str': 'Flashing (disorder)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C3873850', 'cui_str': 'Glucose monitoring system'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0344323', 'cui_str': 'Flashing (disorder)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",299.0,0.103683,Diabetes-specific distress PAID scores were unchanged at 12 months (between-group difference,"[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Furler', 'Affiliation': 'Department of General Practice, University of Melbourne, Parkville, VIC, Australia. Electronic address: j.furler@unimelb.edu.au.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': ""O'Neal"", 'Affiliation': 'Department of Medicine, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Speight', 'Affiliation': 'School of Psychology, Deakin University, Geelong, VIC, Australia; Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Melbourne, VIC, Australia.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Blackberry', 'Affiliation': 'John Richards Centre for Rural Ageing Research, La Trobe Rural Health School, La Trobe University, Wodonga, VIC, Australia.'}, {'ForeName': 'Jo-Anne', 'Initials': 'JA', 'LastName': 'Manski-Nankervis', 'Affiliation': 'Department of General Practice, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Sharmala', 'Initials': 'S', 'LastName': 'Thuraisingam', 'Affiliation': 'Department of General Practice, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'de La Rue', 'Affiliation': 'Department of General Practice, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Ginnivan', 'Affiliation': 'Department of General Practice, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Doyle', 'Affiliation': 'Department of General Practice, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Holmes-Truscott', 'Affiliation': 'School of Psychology, Deakin University, Geelong, VIC, Australia; Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Melbourne, VIC, Australia.'}, {'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Khunti', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Dalziel', 'Affiliation': 'School of Global and Population Health, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Chiang', 'Affiliation': 'Department of General Practice, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Audehm', 'Affiliation': 'Department of General Practice, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kennedy', 'Affiliation': 'Department of General Practice, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Clark', 'Affiliation': 'Department of General Practice, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Jenkins', 'Affiliation': 'National Health and Medical Research Council of Australia Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Amelia J', 'Initials': 'AJ', 'LastName': 'Lake', 'Affiliation': 'School of Psychology, Deakin University, Geelong, VIC, Australia; Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Melbourne, VIC, Australia.'}, {'ForeName': 'Andrzej S', 'Initials': 'AS', 'LastName': 'Januszewski', 'Affiliation': 'National Health and Medical Research Council of Australia Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Catchpool', 'Affiliation': 'School of Global and Population Health, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Liew', 'Affiliation': 'Centre of Cardiovascular Research and Education in Therapeutics, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Clarke', 'Affiliation': 'School of Global and Population Health, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Best', 'Affiliation': 'Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore; Imperial College London, London, UK.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30385-7']
1598,28847853,Holistic needs assessment and care plans for women with gynaecological cancer: do they improve cancer-specific health-related quality of life? A randomised controlled trial using mixed methods.,"OBJECTIVES


Holistic needs assessment (HNA) and care planning are proposed to address unmet needs of people treated for cancer. We tested whether HNA and care planning by an allied health professional improved cancer-specific quality of life for women following curative treatment for stage I-III gynaecological cancer.
METHODS


Consecutive women were invited to participate in a randomised controlled study (HNA and care planning vs usual care) at a UK cancer centre. Data were collected by questionnaire at baseline, 3 and 6 months. The outcomes were 6-month change in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (version 3), global score (primary) and, in EORTC subscales, generic quality of life and self-efficacy (secondary). The study was blinded for data management and analysis. Differences in outcomes were compared between groups. Health service utilisation and quality-adjusted life years (QALY) (from Short Form-6) were gathered for a cost-effectiveness analysis. Thematic analysis was used to interpret data from an exit interview.
RESULTS


150 women consented (75 per group); 10 undertook interviews. For 124 participants (61 intervention, 63 controls) with complete data, no statistically significant differences were seen between groups in the primary endpoint. The majority of those interviewed reported important personal gains they attributed to the intervention, which reflected trends to improvement seen in EORTC functional and symptom scales. Economic analysis suggests a 62% probability of cost-effectiveness at a £30 000/QALY threshold.
CONCLUSION


Care plan development with an allied health professional is cost-effective, acceptable and useful for some women treated for stage I-III gynaecological cancer. We recommend its introduction early in the pathway to support person-centred care.",2020,"For 124 participants (61 intervention, 63 controls) with complete data, no statistically significant differences were seen between groups in the primary endpoint.","['150 women consented (75 per group); 10 undertook interviews', 'women following curative treatment for stage I-III gynaecological cancer', 'women with gynaecological cancer', 'Consecutive women were invited to participate in a randomised controlled study (HNA and care planning vs usual care) at a UK cancer centre']","['HNA and care planning', 'Holistic needs assessment (HNA) and care planning']","['European Organisation for Research and Treatment of Cancer (EORTC', 'Health service utilisation and quality-adjusted life years (QALY', 'EORTC functional and symptom scales', 'Quality of Life Questionnaire-C30 (version 3), global score (primary) and, in EORTC subscales, generic quality of life and self-efficacy (secondary', 'cancer-specific quality of life']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0558005', 'cui_str': 'Needs Assessment'}]","[{'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C0035168'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0222045'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",150.0,0.178407,"For 124 participants (61 intervention, 63 controls) with complete data, no statistically significant differences were seen between groups in the primary endpoint.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sandsund', 'Affiliation': 'Therapies Department, The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Towers', 'Affiliation': 'Lead Nurse Counsellor, Psychological Support Services, The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Thomas', 'Affiliation': 'Senior Statistician Research Data Management and Statistics Unit, The Royal Marsden NHS Foundation Trust, Sutton, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Tigue', 'Affiliation': 'Therapies Department, The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Amyn', 'Initials': 'A', 'LastName': 'Lalji', 'Affiliation': 'Therapies Department, The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Andreia', 'Initials': 'A', 'LastName': 'Fernandes', 'Affiliation': 'Gynaeoncology Unit, Clinical Services Division, The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Doyle', 'Affiliation': 'Nurse Consultant in Living With and Beyond Cancer, The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Jake', 'Initials': 'J', 'LastName': 'Jordan', 'Affiliation': 'Surrey Health Economics Centre, School of Economics, University of Surrey, Guildford, UK.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Gage', 'Affiliation': 'Surrey Health Economics Centre, School of Economics, University of Surrey, Guildford, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Shaw', 'Affiliation': 'Therapies Department, The Royal Marsden NHS Foundation Trust, London, UK.'}]",BMJ supportive & palliative care,['10.1136/bmjspcare-2016-001207']
1599,29145540,Inverse Association of Peripheral Orexin-A with Insulin Resistance in Type 2 Diabetes Mellitus: A Randomized Clinical Trial.,"AIMS


To investigate the association between serum orexin concentrations and insulin resistance/sensitivity in a sample of patients with type 2 diabetes mellitus, and to study the effects of anti-hyperglycemic treatment on orexin concentrations over three months.
METHODS


This study was designed as a randomized, open-label, clinical trial. Before allocation, sixty medication-naïve, newly-diagnosed, type 2 diabetes patients underwent a 75 g oral glucose tolerance test (OGTT). Afterwards, using a randomized trial design (IRCT201102275917N1) patients were allocated to either the metformin (1000 mg daily) or pioglitazone (30 mg daily) arm, and were reexamined after three months. Serum insulin, plasma glucose, and orexin concentrations were measured at baseline, during OGTT, and after three months.
RESULTS


Orexin concentrations significantly decreased after OGTT (0 vs. 120 min: 0.63 ± 0.07 vs. 0.31 ± 0.03 ng/ml, p < 0.001). Insulin resistance determined by homeostasis model assessment of insulin resistance (HOMA-IR) was significantly and negatively correlated with orexin (r = -0.301, p = 0.024). Furthermore, orexin concentrations were significantly and positively correlated with the insulin sensitivity index derived from OGTT (r = 0.326, p = 0.014). Three-month treatment with metformin and pioglitazone significantly improved insulin sensitivity and increased orexin concentrations by 26% (p = 0.025) and 14% (p = 0.076), respectively. Between-group analysis showed that changes in orexin concentrations with metformin and pioglitazone were not significantly different (p = 0.742).
CONCLUSIONS


There was a negative association between peripheral orexin concentrations and insulin resistance in type 2 diabetes patients. Three-month anti-hyperglycemic treatment with proportionate doses of metformin or pioglitazone increased orexin concentrations via amelioration of insulin resistance and improvement of glycemic control.",2017,"RESULTS


Orexin concentrations significantly decreased after OGTT (0 vs. 120 min: 0.63 ± 0.07 vs. 0.31 ± 0.03 ng/ml, p < 0.001).","['type 2 diabetes patients', 'Type 2 Diabetes Mellitus', 'patients with type 2 diabetes mellitus']","['metformin', '75 g oral glucose tolerance test (OGTT', 'metformin and pioglitazone', 'Peripheral Orexin-A with Insulin Resistance', 'pioglitazone', 'metformin or pioglitazone']","['orexin concentrations', 'serum orexin concentrations and insulin resistance/sensitivity', 'insulin sensitivity and increased orexin concentrations', 'Serum insulin, plasma glucose, and orexin concentrations', 'orexin concentrations via amelioration of insulin resistance and improvement of glycemic control', 'peripheral orexin concentrations and insulin resistance', 'Insulin resistance determined by homeostasis model assessment of insulin resistance (HOMA-IR', 'insulin sensitivity index', 'Orexin concentrations']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C1635037', 'cui_str': 'Metformin / pioglitazone'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0671870', 'cui_str': 'Hypocretin-1'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}]","[{'cui': 'C1113688', 'cui_str': 'Hypocretins'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0650343,"RESULTS


Orexin concentrations significantly decreased after OGTT (0 vs. 120 min: 0.63 ± 0.07 vs. 0.31 ± 0.03 ng/ml, p < 0.001).","[{'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Zarifkar', 'Affiliation': 'Endocrinology and Metabolism Research Center (EMRC), Vali-Asr Hospital, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Noshad', 'Affiliation': 'Endocrinology and Metabolism Research Center (EMRC), Vali-Asr Hospital, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Shahriari', 'Affiliation': 'Endocrinology and Metabolism Research Center (EMRC), Vali-Asr Hospital, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Afarideh', 'Affiliation': 'Endocrinology and Metabolism Research Center (EMRC), Vali-Asr Hospital, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Khajeh', 'Affiliation': 'Endocrinology and Metabolism Research Center (EMRC), Vali-Asr Hospital, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Karimi', 'Affiliation': 'Endocrinology and Metabolism Research Center (EMRC), Vali-Asr Hospital, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Ghajar', 'Affiliation': 'Endocrinology and Metabolism Research Center (EMRC), Vali-Asr Hospital, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Esteghamati', 'Affiliation': 'Endocrinology and Metabolism Research Center (EMRC), Vali-Asr Hospital, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}]",The review of diabetic studies : RDS,['10.1900/RDS.2017.14.301']
1600,31521645,3-Year Outcomes of the DKCRUSH-V Trial Comparing DK Crush With Provisional Stenting for Left Main Bifurcation Lesions.,"OBJECTIVES


The present study aimed to investigate the difference in target lesion failure (TLF) at 3 years after double kissing (DK) crush stenting versus provisional stenting (PS) for unprotected left main distal bifurcation (UPLMb) lesions.
BACKGROUND


The multicenter and randomized DKCRUSH-V (Double Kissing Crush versus Provisional Stenting for Left Main Distal Bifurcation Lesions: The DKCRUSH-V Randomized Trial) study showed fewer 1-year TLF after DK crush for UPLMb lesions compared with PS. The study reports the 3-year clinical outcome of the DKCRUSH-V study.
METHODS


A total of 482 patients with UPLMb lesions who were randomly assigned to either the DK crush group (DK group) or PS group in the DKCRUSH-V study were followed for 3 years. The primary endpoint was the occurrence of a TLF at 3 years. Stent thrombosis (ST) was the safety endpoint. Patients were classified by lesion's complexity and NERS (New Risk Stratification) II or SYNTAX (Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery) score.
RESULTS


At 3 years, TLF occurred in 41 (16.9%) patients in the PS group and in 20 (8.3%) patients in the DK group (p = 0.005), mainly driven by increased target vessel myocardial infarction (5.8% vs. 1.7%; p = 0.017) and target lesion revascularization (10.3% vs. 5.0%; p = 0.029). Definite or probable ST rate at 3 years was 4.1% in the PS group and 0.4% in the DK group (p = 0.006). Notably, DK crush was associated with a significant reduction in both primary and secondary endpoints for patients with complex lesions or at high risk.
CONCLUSIONS


Provisional stenting for UPLMb lesions was associated with significantly increased rates of TLF and ST over 3 years of follow-up. Further randomized study is warranted to confirm the benefits of DK crush stenting for complex UPLMb lesions. (Double Kissing and Double Crush versus Provisional T Stenting Technique for the Treatment of Unprotected Distal Left Main True Bifurcation Lesions: A Randomized, International, Multi-center Clinical Trial; ChiCTR-TRC-11001213).",2019,Provisional stenting for UPLMb lesions was associated with significantly increased rates of TLF and ST over 3 years of follow-up.,"[""Patients were classified by lesion's complexity and NERS (New Risk Stratification) II or SYNTAX (Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery) score"", '482 patients with UPLMb lesions', 'Left Main Distal Bifurcation Lesions']","['DKCRUSH-V (Double Kissing Crush versus Provisional Stenting', 'double kissing (DK) crush stenting versus provisional stenting (PS', 'Provisional Stenting', 'Double Kissing and Double Crush versus Provisional T Stenting Technique', 'DK crush stenting', 'DK crush group (DK group) or PS', 'Provisional stenting']","['target vessel myocardial infarction', 'Definite or probable ST rate', 'rates of TLF and ST', 'Stent thrombosis (ST', 'TLF', 'occurrence of a TLF', 'target lesion failure (TLF', 'target lesion revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0330199', 'cui_str': 'Taxus'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation (procedure)'}]","[{'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0185060', 'cui_str': 'Crushing - action (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]",482.0,0.181288,Provisional stenting for UPLMb lesions was associated with significantly increased rates of TLF and ST over 3 years of follow-up.,"[{'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiaobo', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Jun-Jie', 'Initials': 'JJ', 'LastName': 'Zhang', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Division of Cardiology, Shenyang Northen Hospital, Shenyang, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Kan', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Lianglong', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Division of Cardiology, United Hospital, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Chunguang', 'Initials': 'C', 'LastName': 'Qiu', 'Affiliation': 'Division of Cardiology, Zhengzhou University First Hospital, Zhengzhou, China.'}, {'ForeName': 'Teguh', 'Initials': 'T', 'LastName': 'Santoso', 'Affiliation': 'Division of Cardiology, Medistra Hospital, University of Indonesia Medical School, Jakarta, Indonesia.'}, {'ForeName': 'Chootopol', 'Initials': 'C', 'LastName': 'Paiboon', 'Affiliation': 'Division of Cardiology, Bangkok General Hospital, Bangkok, Thailand.'}, {'ForeName': 'Tak W', 'Initials': 'TW', 'LastName': 'Kwan', 'Affiliation': 'Division of Cardiology, Beth Israel Hospital, New York, New York.'}, {'ForeName': 'Imad', 'Initials': 'I', 'LastName': 'Sheiban', 'Affiliation': 'Division of Cardiology, Pederzoli Hospital-Peschiera del Garda, Verona, Italy.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Leon', 'Affiliation': 'Division of Cardiology, Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Division of Cardiology, Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York. Electronic address: gs2184@columbia.edu.'}, {'ForeName': 'Shao-Liang', 'Initials': 'SL', 'LastName': 'Chen', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China; Key Laboratory of Cardiovascular and Cerebrovascular Medicine, School of Pharmacy, Nanjing Medical University, Nanjing, China. Electronic address: chmengx@126.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.04.056']
1601,31595773,Brinzolamide/brimonidine fixed-dose combination bid as an adjunct to a prostaglandin analog for open-angle glaucoma/ocular hypertension.,"PURPOSE


To evaluate the additive intraocular pressure-lowering effect of twice-daily brinzolamide 1%/brimonidine 0.2% fixed-dose combination (BBFC) as an adjunct to a prostaglandin analog (PGA) in patients with open-angle glaucoma or ocular hypertension insufficiently controlled with PGA monotherapy.
METHODS


In this Phase 4, double-masked trial, patients aged ⩾18 years, with a mean intraocular pressure of ⩾19 and <32 mm Hg in at least one eye were randomized (1:1) to receive BBFC + PGA ( n  = 96) or vehicle + PGA ( n  = 92) for 6 weeks. The primary endpoint was the mean change in diurnal intraocular pressure from baseline (averaged over 09:00 and 11:00 h) at Week 6.
RESULTS


The mean diurnal intraocular pressure at baseline was similar in the BBFC + PGA (22.8 mm Hg) and vehicle + PGA (22.9 mm Hg) groups. The least squares mean change in diurnal intraocular pressure from baseline at Week 6 was greater with BBFC + PGA (-5.59 mm Hg (95% confidence interval: -6.2 to -5.0)) than with vehicle + PGA (-2.15 mm Hg (95% confidence interval: -2.7 to -1.6)); the treatment difference was statistically significant in favor of BBFC + PGA (-3.44 mm Hg, (95% confidence interval: -4.2 to -2.7);  p  < 0.001). Ocular adverse events were reported in 21.1% and 8.7% of patients in the BBFC + PGA and vehicle + PGA groups, respectively. The most frequent ocular adverse event was ocular hyperemia (5.3%) in the BBFC + PGA group and blurred vision (2.2%) in the vehicle + PGA group.
CONCLUSION


BBFC + PGA significantly reduced mean diurnal intraocular pressure than PGA alone in patients with open-angle glaucoma or ocular hypertension. The safety findings with BBFC + PGA were consistent with the known safety profile of the individual medications.",2019,+ PGA significantly reduced mean diurnal intraocular pressure than PGA alone in patients with open-angle glaucoma or ocular hypertension.,"['open-angle glaucoma/ocular hypertension', 'patients with open-angle glaucoma or ocular hypertension insufficiently controlled with PGA monotherapy', 'patients aged ⩾18 years, with a mean intraocular pressure of ⩾19 and <32 mm Hg in at least one eye', 'patients with open-angle glaucoma or ocular hypertension']","['BBFC + PGA', 'PGA alone', 'twice-daily brinzolamide 1%/brimonidine 0.2% fixed-dose combination (BBFC', 'Brinzolamide/brimonidine', 'BBFC', 'prostaglandin analog', 'vehicle + PGA', 'prostaglandin analog (PGA', ' PGA']","['BBFC + PGA', 'ocular hyperemia', 'mean diurnal intraocular pressure', 'blurred vision', 'Ocular adverse events', 'diurnal intraocular pressure', 'mean change in diurnal intraocular pressure']","[{'cui': 'C0017612', 'cui_str': 'Glaucoma, Compensated'}, {'cui': 'C0028840', 'cui_str': 'Ocular Hypertension'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0673966', 'cui_str': 'brinzolamide'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0525227', 'cui_str': 'brimonidine'}, {'cui': 'C0033568', 'cui_str': 'Prostaglandin Analogs'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}]","[{'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C0155169', 'cui_str': 'Ocular hyperemia (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.484966,+ PGA significantly reduced mean diurnal intraocular pressure than PGA alone in patients with open-angle glaucoma or ocular hypertension.,"[{'ForeName': 'Fotis', 'Initials': 'F', 'LastName': 'Topouzis', 'Affiliation': 'Department of Ophthalmology, School of Medicine, Aristotle University of Thessaloniki, AHEPA Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Goldberg', 'Affiliation': 'Discipline of Ophthalmology, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Bell', 'Affiliation': 'Department of Ophthalmology, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Tatham', 'Affiliation': 'Princess Alexandra Eye Pavilion and Department of Ophthalmology, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Ridolfi', 'Affiliation': 'Novartis Pharma S.A.S, Rueil-Malmaison, France.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Hubatsch', 'Affiliation': 'Novartis Pharmaceutical Corporation, Fort Worth, TX, USA.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Nicolela', 'Affiliation': 'Department of Ophthalmology & Visual Sciences, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Phillipe', 'Initials': 'P', 'LastName': 'Denis', 'Affiliation': ""Service d'Ophtalmologie, Hôpital de la Croix-Rousse, Lyon, France.""}, {'ForeName': 'S Fabian', 'Initials': 'SF', 'LastName': 'Lerner', 'Affiliation': 'Consultorio Oftalmologico Dr. Fabian Lerner and Facultad de Ciencias Medicas, Universidad Favaloro, Buenos Aires, Argentina.'}]",European journal of ophthalmology,['10.1177/1120672119878044']
1602,31596491,Association of Estimated Pulse Wave Velocity With Survival: A Secondary Analysis of SPRINT.,"Importance


Aortic stiffness, as assessed by carotid-femoral pulse wave velocity, is an independent predictor of future events in individuals with hypertension. Recent data suggest a predictive role of estimated pulse wave velocity (ePWV) calculated by previously published equations using age and blood pressure in future events in individuals with hypertension.
Objective


To investigate whether ePWV and its response to treatment predict survival in the Systolic Blood Pressure Intervention Trial (SPRINT).
Design, Setting, and Participants


This exploratory, hypothesis-generating, post hoc secondary analysis conducted from October 1, 2018, to August 31, 2019, examined data from 9361 participants in SPRINT and calculated ePWV at baseline and at 12 months. Adjusted hazard ratios (HRs) with 95% CIs of ePWV per 1 SD were estimated using Cox proportional hazards regression models. A total of 8450 patients were assigned to 4 groups according to their treatment allocation and their response in ePWV after 12 months.
Interventions


Participants were assigned a systolic blood pressure target of less than 120 mm Hg (intensive treatment) or less than 140 mm Hg (standard treatment).
Main Outcomes and Measures


The primary composite cardiovascular outcome was myocardial infarction, other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes.
Results


In the SPRINT population (3332 women and 6029 men; mean [SD] age, 67.9 [9.4] years), ePWV predicted the primary outcome (HR, 1.30 [95% CI, 1.17-1.43]; P < .001) and all-cause death (HR, 1.65 [95% CI, 1.46-1.86]; P < .001) independent of the Framingham Risk Score. Estimated pulse wave velocity improved the C statistic model for the primary outcome from 0.676 (95% CI, 0.65-0.70) to 0.683 (95% CI, 0.66-0.71; P = .049) and improved the C statistic model for all-cause death from 0.67 (95% CI, 0.64-0.69) to 0.69 (95% CI, 0.66-0.72; P = .03). Net reclassification index indicated improvement in risk discrimination for survival compared with the Framingham Risk Score (categorical net reclassification index = 0.111; P < .001). Regarding response to treatment, intensive treatment was superior to standard treatment only when it was accompanied with a response in ePWV at the first year, while, within the standard treatment group, individuals whose ePWV responded to antihypertensive treatment had improved all-cause mortality, with a 42% lower risk of death compared with nonresponders (HR, 0.58 [95% CI, 0.36-0.94]; P = .03); effects were independent of changes in systolic blood pressure.
Conclusions and Relevance


These results suggest that, in the SPRINT trial, ePWV predicted outcomes independent of the Framingham Risk Score, indicating an incremental role of markers of aortic stiffness on cardiovascular risk. Better survival of individuals whose ePWV responded to antihypertensive treatment independently of systolic blood pressure reduction suggests a role of markers of aortic stiffness as effective treatment targets in individuals with hypertension.",2019,"Estimated pulse wave velocity improved the C statistic model for the primary outcome from 0.676 (95% CI, 0.65-0.70) to 0.683 (95% CI, 0.66-0.71; P = .049) and improved the C statistic model for all-cause death from 0.67 (95% CI, 0.64-0.69) to 0.69 (95% CI, 0.66-0.72; P = .03).","['individuals with hypertension', '8450 patients']",['systolic blood pressure target of less than 120 mm Hg (intensive treatment) or less than 140 mm Hg (standard treatment'],"['myocardial infarction, other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes', 'cause mortality', 'Estimated Pulse Wave Velocity With Survival', 'cardiovascular risk', 'C statistic model', 'risk of death', 'Adjusted hazard ratios (HRs', 'systolic blood pressure', 'risk discrimination for survival']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}]",3332.0,0.287451,"Estimated pulse wave velocity improved the C statistic model for the primary outcome from 0.676 (95% CI, 0.65-0.70) to 0.683 (95% CI, 0.66-0.71; P = .049) and improved the C statistic model for all-cause death from 0.67 (95% CI, 0.64-0.69) to 0.69 (95% CI, 0.66-0.72; P = .03).","[{'ForeName': 'Charalambos', 'Initials': 'C', 'LastName': 'Vlachopoulos', 'Affiliation': 'Hypertension and Cardiometabolic Unit, First Department of Cardiology, Hippokration Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Terentes-Printzios', 'Affiliation': 'Hypertension and Cardiometabolic Unit, First Department of Cardiology, Hippokration Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Laurent', 'Affiliation': 'Department of Pharmacology, European Georges Pompidou Hospital, Assistance Publique Hôpitaux de Paris, Inserm UMR 970, University Paris Descartes, Paris, France.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Nilsson', 'Affiliation': 'Department of Clinical Sciences, Lund University, University Hospital, Malmö, Sweden.'}, {'ForeName': 'Athanase D', 'Initials': 'AD', 'LastName': 'Protogerou', 'Affiliation': 'Cardiovascular Prevention and Research Unit, Clinic and Laboratory of Pathophysiology, Laiko Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Konstatinos', 'Initials': 'K', 'LastName': 'Aznaouridis', 'Affiliation': 'Hypertension and Cardiometabolic Unit, First Department of Cardiology, Hippokration Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Xaplanteris', 'Affiliation': 'Hypertension and Cardiometabolic Unit, First Department of Cardiology, Hippokration Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Iosif', 'Initials': 'I', 'LastName': 'Koutagiar', 'Affiliation': 'Hypertension and Cardiometabolic Unit, First Department of Cardiology, Hippokration Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Tomiyama', 'Affiliation': 'Division of Preemptive Medicine for Vascular Damage, Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Yamashina', 'Affiliation': 'Division of Preemptive Medicine for Vascular Damage, Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Petros P', 'Initials': 'PP', 'LastName': 'Sfikakis', 'Affiliation': 'First Department of Propaedeutic Internal Medicine, Medical School, Laiko General Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Tousoulis', 'Affiliation': 'Hypertension and Cardiometabolic Unit, First Department of Cardiology, Hippokration Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.12831']
1603,30325529,"Follow-up study of the early, randomised paracetamol trial to preterm infants, found no adverse reactions at the two-years corrected age.","AIM


We examined the long-term outcomes and safety of early intravenous paracetamol for ductus arteriosus closure at a corrected age of two years.
METHODS


This was a follow-up of the 2013-2014 randomised, double-blind Preterm Infant's Paracetamol Study at Oulu University Hospital, Finland, which recruited 48 very preterm infants within 24 hours of birth. They received intravenous paracetamol or a placebo for four days. In 2015-2017, we followed up 44 infants (92%) at two years of corrected age. This included clinical and neurodevelopmental assessments and a parental medical history questionnaire.
RESULTS


The 44 infants (55% boys) were born at 23 5  -31 6  weeks of gestation. No differences in the cardiac parameters, including blood pressures and ultrasound scan results, were found. Neurodevelopmental stages, as quantified by the Griffiths test, were similar. No signs of autism were reported. Asthma medication was more common in the control group, but the difference was not significant. Atopy scores, numbers of infections and the use of public health services were similar between the two groups.
CONCLUSION


No long-term adverse reactions of early intravenous paracetamol were detected two years later. Larger trials are needed on the safety and efficacy of paracetamol prophylaxis for early ductal closure in very preterm infants.",2019,"Atopy scores, numbers of infections and the use of public health services were similar between the two groups.
","['ductus arteriosus closure at a corrected age of two years', 'very preterm infants', ""2013-2014 randomised, double-blind Preterm Infant's Paracetamol Study at Oulu University Hospital, Finland, which recruited 48 very preterm infants within 24 hours of birth"", '44 infants (55% boys) were born at 23 5  -31 6  weeks of gestation']","['intravenous paracetamol', 'paracetamol', 'placebo', 'paracetamol prophylaxis']","['adverse reactions', 'Atopy scores, numbers of infections and the use of public health services', 'cardiac parameters, including blood pressures and ultrasound scan results']","[{'cui': 'C0013273', 'cui_str': 'Ductus Arteriosus'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0392707', 'cui_str': 'Atopy (disorder)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0699943', 'cui_str': 'Public health service (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",48.0,0.164519,"Atopy scores, numbers of infections and the use of public health services were similar between the two groups.
","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Juujärvi', 'Affiliation': 'PEDEGO Research Center and MRC Oulu, University of Oulu, Oulu, Finland.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kallankari', 'Affiliation': 'PEDEGO Research Center and MRC Oulu, University of Oulu, Oulu, Finland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Pätsi', 'Affiliation': 'PEDEGO Research Center and MRC Oulu, University of Oulu, Oulu, Finland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Leskinen', 'Affiliation': 'PEDEGO Research Center and MRC Oulu, University of Oulu, Oulu, Finland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Saarela', 'Affiliation': 'PEDEGO Research Center and MRC Oulu, University of Oulu, Oulu, Finland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hallman', 'Affiliation': 'PEDEGO Research Center and MRC Oulu, University of Oulu, Oulu, Finland.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Aikio', 'Affiliation': 'PEDEGO Research Center and MRC Oulu, University of Oulu, Oulu, Finland.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.14614']
1604,31601496,"Patient-reported outcomes with durvalumab after chemoradiotherapy in stage III, unresectable non-small-cell lung cancer (PACIFIC): a randomised, controlled, phase 3 study.","BACKGROUND


In the ongoing, phase 3 PACIFIC trial, durvalumab improved the primary endpoints of progression-free survival and overall survival compared with that for placebo, with similar safety, in patients with unresectable, stage III non-small-cell lung cancer. In this analysis, we aimed to evaluate one of the secondary endpoints, patient-reported outcomes (PROs).
METHODS


PACIFIC is an ongoing, international, multicentre, double-blind, randomised, controlled, phase 3 trial. Eligible patients were aged at least 18 years, had a WHO performance status of 0 or 1, with histologically or cytologically documented stage III, unresectable non-small-cell lung cancer, for which they had received at least two cycles of platinum-based chemoradiotherapy, with no disease progression after this treatment. We randomly assigned patients (2:1) using an interactive voice response system and a blocked design (block size=3) stratified by age, sex, and smoking history to receive 10 mg/kg intravenous durvalumab or matching placebo 1-42 days after concurrent chemoradiotherapy, then every 2 weeks up to 12 months. The primary endpoints of progression-free survival and overall survival have been reported previously. PROs were a prespecified secondary outcome. We assessed PRO symptoms, functioning, and global health status or quality of life in the intention-to-treat population with the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) version 3 and its lung cancer module, the Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) at the time of random allocation to groups, at weeks 4 and 8, every 8 weeks until week 48, and then every 12 weeks until progression. Changes from baseline to 12 month in key symptoms were analysed with mixed model for repeated measures (MMRM) and time-to-event analyses. A 10-point or greater change from baseline (deterioration or improvement) was deemed clinically relevant. This study is registered with ClinicalTrials.gov, NCT02125461, and EudraCT, 2014-000336-42.
FINDINGS


Between May 9, 2014, and April 22, 2016, 476 patients were assigned to receive durvalumab, and 237 patients were assigned to receive placebo. As of March 22, 2018, the median follow-up was 25·2 months (IQR 14·1-29·5). More than 79% of patients given durvalumab and more than 82% of patients given placebo completed questionnaires up to week 48. Between baseline and 12 months, the prespecified longitudinal PROs of interest, cough (MMRM-adjusted mean change 1·8 [95% CI 0·06 to 3·54] in the durvalumab group vs 0·7 [-1·91 to 3·30] in the placebo group), dyspnoea (3·1 [1·75 to 4·36] vs 1·4 [-0·51 to 3·34]), chest pain (-3·1 [-4·57 to -1·60] vs -3·5 [-5·68 to -1·29]), fatigue (-3·0 [-4·53 to -1·50] vs -5·2 [-7·45 to -2·98]), appetite loss (-5·8 [-7·28 to -4·36] vs -7·0 [-9·17 to -4·87]), physical functioning (0·1 [-1·10 to 1·28] vs 2·0 [0·22 to 3·73]), and global health status or quality of life (2·6 [1·21 to 3·94] vs 1·8 [-0·25 to 3·81]) remained stable with both treatments, with no clinically relevant changes from baseline. The between-group differences in changes from baseline to 12 months in cough (difference in adjusted mean changes 1·1, 95% CI -1·89 to 4·11), dyspnoea (1·6, -0·58 to 3·87), chest pain (0·4, -2·13 to 2·93), fatigue (2·2, -0·38 to 4·78), appetite loss (1·2, -1·27 to 3·67), physical functioning (-1·9, -3·91 to 0·15), or global health status or quality of life (0·8, -1·55 to 3·14) were not clinically relevant. Generally, there were no clinically important between-group differences in time to deterioration of prespecified key PRO endpoints.
INTERPRETATION


Our findings suggest that a clinical benefit with durvalumab can be attained without compromising PROs. This result is of note because the previous standard of care was observation alone, with no presumed detriment to PROs.
FUNDING


AstraZeneca.",2019,More than 79% of patients given durvalumab and more than 82% of patients given placebo completed questionnaires up to week 48.,"['1·8', 'Between May 9, 2014, and April 22, 2016', 'Eligible patients were aged at least 18 years, had a WHO performance status of 0 or 1, with histologically or cytologically documented stage III, unresectable non-small-cell lung cancer, for which they had received at least two cycles of platinum-based chemoradiotherapy, with no disease progression after this treatment', 'stage III, unresectable non-small-cell lung cancer (PACIFIC', '476 patients were assigned to receive durvalumab, and 237 patients', 'patients with unresectable, stage III non-small-cell lung cancer']","['interactive voice response system and a blocked design (block size=3) stratified by age, sex, and smoking history to receive 10 mg/kg intravenous durvalumab or matching placebo', '4·36', 'placebo', 'durvalumab after chemoradiotherapy', '3·5']","['appetite loss (-5·8', 'global health status or quality of life (2·6', 'Quality of Life Questionnaire-Core 30 (QLQ-C30) version 3 and its lung cancer module, the Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13', 'PRO symptoms, functioning, and global health status or quality of life in the intention-to-treat population with the European Organisation for Research and Treatment of Cancer (EORTC', 'dyspnoea ', 'prespecified longitudinal PROs of interest, cough (MMRM-adjusted mean change', 'progression-free survival and overall survival', 'physical functioning (0·1', 'dyspnoea (1·6, -0·58 to 3·87), chest pain (0·4, -2·13 to 2·93), fatigue (2·2, -0·38 to 4·78), appetite loss (1·2, -1·27 to 3·67), physical functioning (-1·9, -3·91 to 0·15), or global health status or quality of life', 'chest pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}]","[{'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C0035168'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",476.0,0.450892,More than 79% of patients given durvalumab and more than 82% of patients given placebo completed questionnaires up to week 48.,"[{'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Hui', 'Affiliation': 'Department of Medical Oncology, Westmead Hospital and the University of Sydney, Sydney, NSW, Australia. Electronic address: rina.hui@sydney.edu.au.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Özgüroğlu', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Cerrahpaşa School of Medicine, Istanbul University Cerrahpaşa, Istanbul, Turkey.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Villegas', 'Affiliation': 'Cancer Specialists of North Florida, Jacksonville, FL, USA.'}, {'ForeName': 'Davey', 'Initials': 'D', 'LastName': 'Daniel', 'Affiliation': 'Sarah Cannon Research Institute, Nashville and Tennessee Oncology, Chattanooga, TN, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Vicente', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario Virgen Macarena, Seville, Spain.'}, {'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Murakami', 'Affiliation': 'Department of Thoracic Oncology, Kanagawa Cancer Centre, Kanagawa, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Yokoi', 'Affiliation': 'Department of Thoracic Oncology, Kansai Medical University Hospital, Hirakata, Japan.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Chiappori', 'Affiliation': 'Thoracic Oncology Program, H Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.'}, {'ForeName': 'Ki Hyeong', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, College of Medicine, Chungbuk National University Hospital, Cheongju, Korea.'}, {'ForeName': 'Maike', 'Initials': 'M', 'LastName': 'de Wit', 'Affiliation': 'Department of Internal Medicine-Hematology, Oncology and Palliative Medicine, Vivantes Klinikum Neukölln, Berlin, Germany.'}, {'ForeName': 'Byoung Chul', 'Initials': 'BC', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Yonsei Cancer Centre, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jhanelle E', 'Initials': 'JE', 'LastName': 'Gray', 'Affiliation': 'Thoracic Oncology Program, H Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rydén', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Viviers', 'Affiliation': 'IQVIA, Saint-Ouen, France.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Poole', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Yiduo', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Phillip A', 'Initials': 'PA', 'LastName': 'Dennis', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Antonia', 'Affiliation': 'Thoracic Oncology Program, H Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30519-4']
1605,31599810,Reduction of Postoperative Wound Infections by Antiseptica (RECIPE)?: A Randomized Controlled Trial.,"OBJECTIVE


To evaluate whether intraoperative subcutaneous wound irrigation with 0.04% polyhexanide can reduce surgical site infection (SSI) in elective laparotomies compared to saline.
BACKGROUND


SSI is a common complication after gastrointestinal surgery. To date, there is a lack of evidence whether subcutaneous wound irrigation is beneficial in terms of reduction of SSI.
METHODS


The RECIPE trial was an investigator initiated single-center, single-blind prospective, randomized controlled trial with 2 parallel treatment groups, comparing wound irrigation with 0.9% saline to antiseptic 0.04% polyhexanide solution in elective laparotomies. Primary endpoint was the rate of SSI within 30 days postoperatively according to Centers for Disease Control and Prevention criteria.
RESULTS


Between February 02, 2015, and May 23, 2018, 456 patients were randomly assigned to saline (n = 228) or polyhexanide (n = 228). Final cohort for analysis comprised 393 patients (202 in the saline and 191 in the polyhexanide group). Overall rate of SSI was 28.2%, n = 111. Simple analysis with cross tabulation revealed that significantly fewer SSIs occurred in the polyhexanide group: n = 70 (34.7%) versus n = 41 (21.5%); P = 0.004. In a multiple logistic regression model the factor wound irrigation with polyhexanide [odds ratio (OR) 0.44; 95% confidence interval (CI) 0.27-0.72; P = 0.001) was associated with risk reduction of SSI. Preoperative anemia (OR 2.08; 95% CI 1.27-3.40; P = 0.004) and more than 5 prior abdominal operations compared to none (OR 8.51; 95% CI 2.57-28.21; P < 0.001) were associated with SSI.
CONCLUSIONS


Intraoperative subcutaneous wound irrigation with antiseptic 0.04% polyhexanide solution is effective in reducing SSI after elective laparotomies.",2020,"Preoperative anemia (OR 2.08; 95% CI 1.27-3.40; P = 0.004) and more than 5 prior abdominal operations compared to none (OR 8.51; 95% CI 2.57-28.21; P < 0.001) were associated with SSI.
","['Between February 02, 2015, and May 23, 2018, 456 patients', '393 patients (202 in the saline and 191 in the polyhexanide group']","['Antiseptica (RECIPE', 'intraoperative subcutaneous wound irrigation with 0.04% polyhexanide', 'saline', 'antiseptic 0.04% polyhexanide solution', 'wound irrigation with 0.9% saline to antiseptic 0.04% polyhexanide solution', 'polyhexanide']","['Overall rate of SSI', 'SSIs', 'rate of SSI within 30 days postoperatively according to Centers for Disease Control and Prevention criteria', 'surgical site infection (SSI', 'risk reduction of SSI', 'Preoperative anemia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517754', 'cui_str': 'Three hundred and ninety-three'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0376892', 'cui_str': 'polihexanide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0600194', 'cui_str': 'Recipes'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0150410', 'cui_str': 'Irrigation of wound (procedure)'}, {'cui': 'C4517407', 'cui_str': 'Zero point zero four'}, {'cui': 'C0376892', 'cui_str': 'polihexanide'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C3540796', 'cui_str': 'Antiseptic throat preparations'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0007670', 'cui_str': 'CDC'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",456.0,0.287261,"Preoperative anemia (OR 2.08; 95% CI 1.27-3.40; P = 0.004) and more than 5 prior abdominal operations compared to none (OR 8.51; 95% CI 2.57-28.21; P < 0.001) were associated with SSI.
","[{'ForeName': 'Rahel M', 'Initials': 'RM', 'LastName': 'Strobel', 'Affiliation': 'Department of General, Visceral and Vascular Surgery, Charité Campus Benjamin Franklin, Hindenburgdamm, Berlin, Germany.'}, {'ForeName': 'Marja', 'Initials': 'M', 'LastName': 'Leonhardt', 'Affiliation': 'Innlandet Hospital Trust, Norwegian National Advisory Unit on Concurrent Substance Abuse and Mental Health Disorders, Brumunddal, Norway.'}, {'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Krochmann', 'Affiliation': 'Department of General, Visceral and Vascular Surgery, Charité Campus Benjamin Franklin, Hindenburgdamm, Berlin, Germany.'}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Neumann', 'Affiliation': 'Institute of Biometry and Clinical Epidemiology, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität Berlin and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Speichinger', 'Affiliation': 'Department of General, Visceral and Vascular Surgery, Charité Campus Benjamin Franklin, Hindenburgdamm, Berlin, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Hartmann', 'Affiliation': 'Department of General, Visceral and Vascular Surgery, Charité Campus Benjamin Franklin, Hindenburgdamm, Berlin, Germany.'}, {'ForeName': 'Lucas D', 'Initials': 'LD', 'LastName': 'Lee', 'Affiliation': 'Department of General, Visceral and Vascular Surgery, Charité Campus Benjamin Franklin, Hindenburgdamm, Berlin, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Beyer', 'Affiliation': 'Department of General, Visceral and Vascular Surgery, Charité Campus Benjamin Franklin, Hindenburgdamm, Berlin, Germany.'}, {'ForeName': 'Severin', 'Initials': 'S', 'LastName': 'Daum', 'Affiliation': 'Department of Gastroenterology, Rheumatology and Infectious Diseases, Charité Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Martin E', 'Initials': 'ME', 'LastName': 'Kreis', 'Affiliation': 'Department of General, Visceral and Vascular Surgery, Charité Campus Benjamin Franklin, Hindenburgdamm, Berlin, Germany.'}, {'ForeName': 'Johannes C', 'Initials': 'JC', 'LastName': 'Lauscher', 'Affiliation': 'Department of General, Visceral and Vascular Surgery, Charité Campus Benjamin Franklin, Hindenburgdamm, Berlin, Germany.'}]",Annals of surgery,['10.1097/SLA.0000000000003645']
1606,28541646,Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) for Hoarding Disorder in Older Adults: A Randomized Clinical Trial.,"OBJECTIVE


To compare the efficacy of Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) with geriatric case management (CM) in a sample of older adults meeting DSM-5 diagnostic criteria for hoarding disorder (HD).
METHODS


Fifty-eight older adults with HD were enrolled in a randomized controlled trial between December 2011 and March 2014. Thirty-one participants received CREST, and 27 participants received CM. Both interventions consisted of 26 individual sessions over a period of 6 months and included several home visits by the study therapists (CREST) or nurses (CM). The Saving Inventory-Revised (SI-R) and the UCLA Hoarding Severity Scale (UHSS) were the main outcome measures.
RESULTS


Participants in the CREST condition had significantly greater improvement on the SI-R than participants in the CM group (group × time interaction: β = 3.95, SE = 1.81, P = .029), with participants who completed the CREST condition averaging a 38% decrease in symptoms and participants who completed the CM condition averaging a 25% decrease in symptoms. In contrast, there was not a significant group × time interaction effect on the UHSS (β = 1.23, SE = 0.84, P = .144), although participants did report greater improvement in symptoms in the CREST condition (35%) than in the CM condition (24%). Treatment gains were maintained at 6-month follow-up.
CONCLUSIONS


CREST appears to be an efficacious treatment compared to CM for older adults, but CM also showed meaningful benefits.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT01227057​.",2018,"RESULTS


Participants in the CREST condition had significantly greater improvement on the SI-R than participants in the CM group (group × time interaction: β = 3.95, SE = 1.81, P = .029), with participants who completed the CREST condition averaging a 38% decrease in symptoms and participants who completed the CM condition averaging a 25% decrease in symptoms.","['Fifty-eight older adults with HD were enrolled in a randomized controlled trial between December 2011 and March 2014', 'older adults meeting DSM-5 diagnostic criteria for hoarding disorder (HD', 'Older Adults']","['CM', 'Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) with geriatric case management (CM', 'Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST']","['Saving Inventory-Revised (SI-R) and the UCLA Hoarding Severity Scale (UHSS', 'SI-R', 'time interaction effect']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3837219', 'cui_str': 'Hoarding Disorder'}]","[{'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C0085971', 'cui_str': 'Case Management'}, {'cui': 'C2948667', 'cui_str': 'Crest'}]","[{'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0424337', 'cui_str': 'Hoarding'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",58.0,0.092837,"RESULTS


Participants in the CREST condition had significantly greater improvement on the SI-R than participants in the CM group (group × time interaction: β = 3.95, SE = 1.81, P = .029), with participants who completed the CREST condition averaging a 38% decrease in symptoms and participants who completed the CM condition averaging a 25% decrease in symptoms.","[{'ForeName': 'Catherine R', 'Initials': 'CR', 'LastName': 'Ayers', 'Affiliation': '3350 La Jolla Village Drive, 116B, San Diego, CA 92161. cayers@ucsd.edu.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Dozier', 'Affiliation': 'San Diego State University/University of California, San Diego Joint Doctoral Program in Clinical Psychology, San Diego, California, USA.'}, {'ForeName': 'Elizabeth W', 'Initials': 'EW', 'LastName': 'Twamley', 'Affiliation': 'Department of Psychiatry, University of California, San Diego School of Medicine, San Diego, California, USA.'}, {'ForeName': 'Sanjaya', 'Initials': 'S', 'LastName': 'Saxena', 'Affiliation': 'Department of Psychiatry, University of California, San Diego School of Medicine, San Diego, California, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Granholm', 'Affiliation': 'Mental Health Care Line, VA San Diego Healthcare System, San Diego, California, USA.'}, {'ForeName': 'Tina L', 'Initials': 'TL', 'LastName': 'Mayes', 'Affiliation': 'Research Service, VA San Diego Healthcare System, San Diego, California, USA.'}, {'ForeName': 'Julie Loebach', 'Initials': 'JL', 'LastName': 'Wetherell', 'Affiliation': 'Mental Health Care Line, VA San Diego Healthcare System, San Diego, California, USA.'}]",The Journal of clinical psychiatry,['10.4088/JCP.16m11072']
1607,25575599,Personalized contact strategies and predictors of time to survey completion: analysis of two sequential randomized trials.,"BACKGROUND


Effective strategies for contacting and recruiting study participants are critical in conducting clinical research. In this study, we conducted two sequential randomized controlled trials of mail- and telephone-based strategies for contacting and recruiting participants, and evaluated participant-related variables' association with time to survey completion and survey completion rates. Subjects eligible for this study were survivors of acute lung injury who had been previously enrolled in a 12-month observational follow-up study evaluating their physical, cognitive and mental health outcomes, with their last study visit completed at a median of 34 months previously.
METHODS


Eligible subjects were contacted to complete a new research survey as part of two randomized trials, initially using a randomized mail-based contact strategy, followed by a randomized telephone-based contact strategy for non-responders to the mail strategy. Both strategies focused on using either a personalized versus a generic approach. In addition, 18 potentially relevant subject-related variables (e.g., demographics, last known physical and mental health status) were evaluated for association with time to survey completion.
RESULTS


Of 308 eligible subjects, 67% completed the survey with a median (IQR) of 3 (2, 5) contact attempts required. There was no significant difference in the time to survey completion for either randomized trial of mail- or phone-based contact strategy. Among all subject-related variables, age ≤40 years and minority race were independently associated with a longer time to survey completion.
CONCLUSION


We found that age ≤40 years and minority race were associated with a longer time to survey completion, but personalized versus generic approaches to mail- and telephone-based contact strategies had no significant effect. Repeating both mail and telephone contact attempts was important for increasing survey completion rate.
TRIAL REGISTRATION


NCT00719446.",2015,There was no significant difference in the time to survey completion for either randomized trial of mail- or phone-based contact strategy.,"['Eligible subjects', '308 eligible subjects', 'Subjects eligible for this study were survivors of acute lung injury who had been previously enrolled in a 12-month observational follow-up study evaluating their physical, cognitive and mental health outcomes, with their last study visit completed at a median of 34 months previously']","['telephone-based contact strategy for non-responders to the mail strategy', 'mail- and telephone']",[],"[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0242488', 'cui_str': 'Acute Lung Injury'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0024492', 'cui_str': 'Mail'}]",[],308.0,0.0951579,There was no significant difference in the time to survey completion for either randomized trial of mail- or phone-based contact strategy.,"[{'ForeName': 'Victor D', 'Initials': 'VD', 'LastName': 'Dinglas', 'Affiliation': ''}, {'ForeName': 'Minxuan', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Kristin A', 'Initials': 'KA', 'LastName': 'Sepulveda', 'Affiliation': ''}, {'ForeName': 'Mariela', 'Initials': 'M', 'LastName': 'Pinedo', 'Affiliation': ''}, {'ForeName': 'Ramona O', 'Initials': 'RO', 'LastName': 'Hopkins', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Colantuoni', 'Affiliation': ''}, {'ForeName': 'Dale M', 'Initials': 'DM', 'LastName': 'Needham', 'Affiliation': 'Outcomes After Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, 1830 E Monument Street, 5th floor, 21205 Baltimore, MD, USA. dale.needham@jhmi.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC medical research methodology,['10.1186/1471-2288-15-5']
1608,25677713,Effects of a food-based intervention on markers of micronutrient status among Indian women of low socio-economic status.,"Intakes of micronutrient-rich foods are low among Indian women of reproductive age. We investigated whether consumption of a food-based micronutrient-rich snack increased markers of blood micronutrient concentrations when compared with a control snack. Non-pregnant women (n 222) aged 14-35 years living in a Mumbai slum were randomised to receive a treatment snack (containing green leafy vegetables, dried fruit and whole milk powder), or a control snack containing foods of low micronutrient content such as wheat flour, potato and tapioca. The snacks were consumed under observation 6 d per week for 12 weeks, compliance was recorded, and blood was collected at 0 and 12 weeks. Food-frequency data were collected at both time points. Compliance (defined as the proportion of women who consumed ≥ 3 snacks/week) was >85 % in both groups. We assessed the effects of group allocation on 12-week nutrient concentrations using ANCOVA models with respective 0-week concentrations, BMI, compliance, standard of living, fruit and green leafy vegetable consumption and use of synthetic nutrients as covariates. The treatment snack significantly increased β-carotene concentrations (treatment effect: 47·1 nmol/l, 95 % CI 6·5, 87·7). There was no effect of group allocation on concentrations of ferritin, retinol, ascorbate, folate or vitamin B12. The present study shows that locally sourced foods can be made into acceptable snacks that may increase serum β-carotene concentrations among women of reproductive age. However, no increase in circulating concentrations of the other nutrients measured was observed.",2015,"There was no effect of group allocation on concentrations of ferritin, retinol, ascorbate, folate or vitamin B12.","['Indian women of low socio-economic status', 'women of reproductive age', 'Indian women of reproductive age', 'pregnant women (n 222) aged 14-35 years living in a Mumbai slum']","['treatment snack (containing green leafy vegetables, dried fruit and whole milk powder), or a control snack containing foods of low micronutrient content such as wheat flour, potato and tapioca', 'consumption of a food-based micronutrient-rich snack', 'food-based intervention', 'micronutrient-rich foods']","['blood micronutrient concentrations', 'β-carotene concentrations', 'concentrations of ferritin, retinol, ascorbate, folate or vitamin B12', 'serum β-carotene concentrations', 'circulating concentrations']","[{'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0337781', 'cui_str': 'Economic Status'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037345', 'cui_str': 'Slums'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3494314', 'cui_str': 'Snacking'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C2348897', 'cui_str': 'Green leafy vegetable'}, {'cui': 'C0453296', 'cui_str': 'Dried fruit (substance)'}, {'cui': 'C0452717', 'cui_str': 'Whole milk (substance)'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0458980', 'cui_str': 'Wheat flour (substance)'}, {'cui': 'C0032846', 'cui_str': 'Potato'}, {'cui': 'C1141016', 'cui_str': 'Tapioca'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0453861', 'cui_str': 'Rich food (substance)'}]","[{'cui': 'C0005768'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0373568', 'cui_str': 'Carotene measurement (procedure)'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}, {'cui': 'C0087161', 'cui_str': 'All-Trans-Retinol'}, {'cui': 'C0857241', 'cui_str': 'Ascorbate'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0042845', 'cui_str': 'cyanocobalamin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}]",222.0,0.0341999,"There was no effect of group allocation on concentrations of ferritin, retinol, ascorbate, folate or vitamin B12.","[{'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Kehoe', 'Affiliation': 'Medical Research Council Lifecourse Epidemiology Unit, University of Southampton,Southampton,UK.'}, {'ForeName': 'Harsha', 'Initials': 'H', 'LastName': 'Chopra', 'Affiliation': 'Centre for Study of Social Change,Mumbai,India.'}, {'ForeName': 'Sirazul A', 'Initials': 'SA', 'LastName': 'Sahariah', 'Affiliation': 'Centre for Study of Social Change,Mumbai,India.'}, {'ForeName': 'Dattatray', 'Initials': 'D', 'LastName': 'Bhat', 'Affiliation': 'Diabetes Unit, King Edward Memorial Hospital Research Centre,Pune,India.'}, {'ForeName': 'Renuka P', 'Initials': 'RP', 'LastName': 'Munshi', 'Affiliation': 'Department of Clinical Pharmacology, Nair Hospital,Mumbai,India.'}, {'ForeName': 'Falguni', 'Initials': 'F', 'LastName': 'Panchal', 'Affiliation': 'Department of Clinical Pharmacology, Nair Hospital,Mumbai,India.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Young', 'Affiliation': 'Medical Research Council Human Nutrition Research, Elsie Widdowson Laboratory,Cambridge,UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Brown', 'Affiliation': 'Medical Research Council Lifecourse Epidemiology Unit, University of Southampton,Southampton,UK.'}, {'ForeName': 'Dnyaneshwar', 'Initials': 'D', 'LastName': 'Tarwande', 'Affiliation': 'Apnalaya,Mumbai,India.'}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Gandhi', 'Affiliation': 'Centre for Study of Social Change,Mumbai,India.'}, {'ForeName': 'Barrie M', 'Initials': 'BM', 'LastName': 'Margetts', 'Affiliation': 'Public Health Nutrition, University of Southampton,Southampton,UK.'}, {'ForeName': 'Ramesh D', 'Initials': 'RD', 'LastName': 'Potdar', 'Affiliation': 'Centre for Study of Social Change,Mumbai,India.'}, {'ForeName': 'Caroline H D', 'Initials': 'CH', 'LastName': 'Fall', 'Affiliation': 'Medical Research Council Lifecourse Epidemiology Unit, University of Southampton,Southampton,UK.'}]",The British journal of nutrition,['10.1017/S000711451400419X']
1609,31540791,"Intensity-modulated fractionated radiotherapy versus stereotactic body radiotherapy for prostate cancer (PACE-B): acute toxicity findings from an international, randomised, open-label, phase 3, non-inferiority trial.","BACKGROUND


Localised prostate cancer is commonly treated with external-beam radiotherapy. Moderate hypofractionation has been shown to be non-inferior to conventional fractionation. Ultra-hypofractionated stereotactic body radiotherapy would allow shorter treatment courses but could increase acute toxicity compared with conventionally fractionated or moderately hypofractionated radiotherapy. We report the acute toxicity findings from a randomised trial of standard-of-care conventionally fractionated or moderately hypofractionated radiotherapy versus five-fraction stereotactic body radiotherapy for low-risk to intermediate-risk localised prostate cancer.
METHODS


PACE is an international, phase 3, open-label, randomised, non-inferiority trial. In PACE-B, eligible men aged 18 years and older, with WHO performance status 0-2, low-risk or intermediate-risk prostate adenocarcinoma (Gleason 4 + 3 excluded), and scheduled to receive radiotherapy were recruited from 37 centres in three countries (UK, Ireland, and Canada). Participants were randomly allocated (1:1) by computerised central randomisation with permuted blocks (size four and six), stratified by centre and risk group, to conventionally fractionated or moderately hypofractionated radiotherapy (78 Gy in 39 fractions over 7·8 weeks or 62 Gy in 20 fractions over 4 weeks, respectively) or stereotactic body radiotherapy (36·25 Gy in five fractions over 1-2 weeks). Neither participants nor investigators were masked to allocation. Androgen deprivation was not permitted. The primary endpoint of PACE-B is freedom from biochemical or clinical failure. The coprimary outcomes for this acute toxicity substudy were worst grade 2 or more severe Radiation Therapy Oncology Group (RTOG) gastrointestinal or genitourinary toxic effects score up to 12 weeks after radiotherapy. Analysis was per protocol. This study is registered with ClinicalTrials.gov, NCT01584258. PACE-B recruitment is complete and follow-up is ongoing.
FINDINGS


Between Aug 7, 2012, and Jan 4, 2018, we randomly assigned 874 men to conventionally fractionated or moderately hypofractionated radiotherapy (n=441) or stereotactic body radiotherapy (n=433). 432 (98%) of 441 patients allocated to conventionally fractionated or moderately hypofractionated radiotherapy and 415 (96%) of 433 patients allocated to stereotactic body radiotherapy received at least one fraction of allocated treatment. Worst acute RTOG gastrointestinal toxic effect proportions were as follows: grade 2 or more severe toxic events in 53 (12%) of 432 patients in the conventionally fractionated or moderately hypofractionated radiotherapy group versus 43 (10%) of 415 patients in the stereotactic body radiotherapy group (difference -1·9 percentage points, 95% CI -6·2 to 2·4; p=0·38). Worst acute RTOG genitourinary toxicity proportions were as follows: grade 2 or worse toxicity in 118 (27%) of 432 patients in the conventionally fractionated or moderately hypofractionated radiotherapy group versus 96 (23%) of 415 patients in the stereotactic body radiotherapy group (difference -4·2 percentage points, 95% CI -10·0 to 1·7; p=0·16). No treatment-related deaths occurred.
INTERPRETATION


Previous evidence (from the HYPO-RT-PC trial) suggested higher patient-reported toxicity with ultrahypofractionation. By contrast, our results suggest that substantially shortening treatment courses with stereotactic body radiotherapy does not increase either gastrointestinal or genitourinary acute toxicity.
FUNDING


Accuray and National Institute of Health Research.",2019,"difference -4·2 percentage points, 95% CI -10·0 to 1·7; p=0·16).","['eligible men aged 18 years and older, with WHO performance status 0-2, low-risk or intermediate-risk prostate adenocarcinoma (Gleason 4\u2008+\u20083 excluded), and scheduled to receive radiotherapy were recruited from 37 centres in three countries (UK, Ireland, and Canada', '874 men to', '432 (98%) of 441 patients allocated to', 'Between Aug 7, 2012, and Jan 4, 2018', '433 patients allocated to']","['hypofractionated radiotherapy', 'stereotactic body radiotherapy', 'Intensity-modulated fractionated radiotherapy versus stereotactic body radiotherapy', 'conventionally fractionated or moderately hypofractionated radiotherapy (n=441) or stereotactic body radiotherapy', 'conventionally fractionated or moderately hypofractionated radiotherapy', 'Ultra-hypofractionated stereotactic body radiotherapy', 'standard-of-care conventionally fractionated or moderately hypofractionated radiotherapy versus five-fraction stereotactic body radiotherapy', 'external-beam radiotherapy', 'conventionally fractionated or moderately hypofractionated', 'radiotherapy']","['acute toxicity substudy were worst grade 2 or more severe Radiation Therapy Oncology Group (RTOG) gastrointestinal or genitourinary toxic effects score', 'acute toxicity', 'toxicity', 'Androgen deprivation', 'PACE-B is freedom from biochemical or clinical failure', 'gastrointestinal or genitourinary acute toxicity', 'severe toxic events']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0022067', 'cui_str': 'Ireland, Republic of'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure (procedure)'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",874.0,0.279497,"difference -4·2 percentage points, 95% CI -10·0 to 1·7; p=0·16).","[{'ForeName': 'Douglas H', 'Initials': 'DH', 'LastName': 'Brand', 'Affiliation': 'The Royal Marsden Hospital, London, UK; The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Alison C', 'Initials': 'AC', 'LastName': 'Tree', 'Affiliation': 'The Royal Marsden Hospital, London, UK; The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ostler', 'Affiliation': 'Mount Vernon Cancer Centre, Northwood, UK.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'van der Voet', 'Affiliation': 'The James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Loblaw', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Chu', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ford', 'Affiliation': 'University Hospitals Birmingham, Birmingham, UK.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Tolan', 'Affiliation': 'The Clatterbridge Cancer Centre, Birkenhead, UK.'}, {'ForeName': 'Suneil', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': ""Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Staffurth', 'Affiliation': 'Cardiff University, Cardiff, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Camilleri', 'Affiliation': 'Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Kancherla', 'Affiliation': 'University Hospitals of Leicester, Leicester, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Frew', 'Affiliation': 'Freeman Hospital, Newcastle, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Chan', 'Affiliation': 'University Hospitals Coventry & Warwickshire, Coventry, UK.'}, {'ForeName': 'Ian S', 'Initials': 'IS', 'LastName': 'Dayes', 'Affiliation': 'Department of Oncology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Henderson', 'Affiliation': 'University Hospitals Birmingham, Birmingham, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Brown', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Cruickshank', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Burnett', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Aileen', 'Initials': 'A', 'LastName': 'Duffton', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Griffin', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Hinder', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Morrison', 'Affiliation': 'The Royal Marsden Hospital, London, UK; The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Naismith', 'Affiliation': 'The Royal Marsden Hospital, London, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'van As', 'Affiliation': 'The Royal Marsden Hospital, London, UK; The Institute of Cancer Research, London, UK. Electronic address: nicholas.vanas@rmh.nhs.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30569-8']
1610,31688431,PrevenTion of contrast-inducEd nephropAThy with urinE alkalinization: the TEATE study design.,": Intravascular administration of iodinated contrast media is an essential tool for the imaging of blood vessels and cardiac chambers, as well as for percutaneous coronary and structural interventions. Along with the spreading of diagnostic and interventional procedures, the increasing incidence of contrast-induced nephropathy (CIN) has become an important and prognostically relevant problem. CIN is thought to be largely dependent on oxidative damage, and is a considerable cause of renal failure, being associated with prolonged hospitalization and significant morbidity/mortality. The most effective treatment strategy of this serious complication remains prevention, and several preventive measures have been extensively investigated in the last few years.Preprocedural hydration is the best-known and mostly accepted strategy. The administration of sodium bicarbonate has controversial effects, and is likely to be ineffective when the infused dose is unable to achieve adequate urine alkalinization. Since alkaline pH suppresses the production of free radicals, increasing urine pH would be an attractive goal for CIN prevention.In a prospective randomized controlled, open-label clinical trial we will test the hypothesis that urine alkalinization with either oral or intravenous bicarbonate on top of hydration alone is the main determinant of CIN prevention (primary endpoint) in a population of patients with moderate or severe chronic kidney disease scheduled for coronary angiography and/or angioplasty. If we then demonstrate nonsignificant differences in urine alkalinization and incidence of CIN between the two bicarbonate groups (secondary endpoint), a practical implication will be that oral administration is preferable for practical reasons over the administration of intravenous bicarbonate.",2020,"If we then demonstrate nonsignificant differences in urine alkalinization and incidence of CIN between the two bicarbonate groups (secondary endpoint), a practical implication will be that oral administration is preferable for practical reasons over the administration of intravenous bicarbonate.",['patients with moderate or severe chronic kidney disease scheduled for coronary angiography and/or angioplasty'],"['oral or intravenous bicarbonate', 'sodium bicarbonate', 'iodinated contrast media', 'bicarbonate']",['urine alkalinization and incidence of CIN'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0005367', 'cui_str': 'Hydrogen Carbonates'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C1960405', 'cui_str': 'Iodinated contrast media'}]","[{'cui': 'C0042037'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",,0.0423409,"If we then demonstrate nonsignificant differences in urine alkalinization and incidence of CIN between the two bicarbonate groups (secondary endpoint), a practical implication will be that oral administration is preferable for practical reasons over the administration of intravenous bicarbonate.","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Lombardi', 'Affiliation': 'Cardiology Department, Institute of Cardiology.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Molisana', 'Affiliation': 'Cardiology Department, Institute of Cardiology.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Genovesi', 'Affiliation': 'Cardiology Department, Institute of Cardiology.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'De Innocentiis', 'Affiliation': 'Cardiology Department, Institute of Cardiology.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'Limbruno', 'Affiliation': 'Cardiology Department, Azienda USL Toscana Sud-Est, Grosseto.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Misuraca', 'Affiliation': 'Cardiology Department, Azienda USL Toscana Sud-Est, Grosseto.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Moretti', 'Affiliation': ""Ospedale 'C.e G. Mazzoni', Ascoli Piceno.""}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Di Vito', 'Affiliation': ""Ospedale 'C.e G. Mazzoni', Ascoli Piceno.""}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Di Nicola', 'Affiliation': ""Department of Biostatistics, G. d'Annunzio University, Chieti.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Zimarino', 'Affiliation': 'Cardiology Department, Institute of Cardiology.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Renda', 'Affiliation': 'Cardiology Department, Institute of Cardiology.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'De Caterina', 'Affiliation': 'Department of Cardiology, University of Pisa, Pisa.'}]","Journal of cardiovascular medicine (Hagerstown, Md.)",['10.2459/JCM.0000000000000892']
1611,31714330,Effects of sacubutril/valsartan on nutritional status in heart failure with reduced ejection fraction.,"BACKGROUND


Malnutrition commonly occurs in patients with heart failure with reduced ejection fraction (HFrEF). Sacubitril/valsartan, which is an AT1 neprilysin inhibitor, has been shown to reduce mortality and hospitalization in patients with HFrEF. However, its effects on nutritional status remain unclear.
METHODS


Sacubitril/valsartan was initiated in 164 symptomatic patients with HFrEF receiving an optimal medical treatment with angiotensin inhibition (mean age: 63 ± 20 years; 120 males, 60% ischemic cause). The New York Heart Association (NYHA) functional class and nutritional statuses of the patients were evaluated at the switching to AT1 neprilysin inhibitor and at the 6th-month follow-up of the maximum sacubitril/valsartan dose using the geriatric nutritional risk index (GNRI), controlling nutritional status (CONUT) score, prognostic nutritional index (PNI), and prealbumin.
RESULTS


After the sacubutril/valsartan treatment, a significant reduction in the number (%) of malnourished patients was observed according to CONUT (before 47% vs. after 7%, P < 0.001), GNRI (before 39% vs. after 19%, P < 0.001), PNI scores (before 36% vs. after 12%, P = 0.002), and prealbumin (before 41% vs. after 12%, P < 0.001). Also significant changes were observed at the baseline and follow-up in the mean scores of the three different nutritional indexes and prealbumin levels [CONUT: 2.68 ± 2.5, 1.02 ± 1.0 (P < 0.001); GNRI: 97.1 ± 9.7, 101.2 ± 5.9 (P < 0.001); PNI: 38.8 ± 4.8, 41.6 ± 3.7 (P < 0.001); prealbumin: 14.6 ± 6.9 mg/dl, 17.1 ± 5.2 mg/dl (P < 0.001)]. Overall, the patients exhibited a significant functional improvement following the initiation of sacubitril/valsartan: 23% of the patients improved by two NYHA classes, 48% improved by one NYHA class, and 39% remained stable.
CONCLUSION


In patients with HFrEF, the switch from angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker therapy to sacubitril/valsartan resulted in a significant improvement in both nutritional and functional statuses.",2020,"Also significant changes were observed at the baseline and follow-up in the mean scores of the three different nutritional indexes and prealbumin levels [CONUT: 2.68 ± 2.5, 1.02 ± 1.0 (P < 0.001); GNRI: 97.1 ± 9.7, 101.2 ± 5.9 (P < 0.001); PNI: 38.8 ± 4.8, 41.6 ± 3.7 (P < 0.001); prealbumin: 14.6 ± 6.9 mg/dl, 17.1 ± 5.2 mg/dl (P < 0.001)].","['patients with heart failure with reduced ejection fraction (HFrEF', 'patients with HFrEF', '164 symptomatic patients with HFrEF receiving an optimal medical treatment with angiotensin inhibition (mean age: 63\u200a±\u200a20 years; 120 males, 60% ischemic cause', 'heart failure with reduced ejection fraction']","['valsartan', 'Sacubitril/valsartan', 'sacubutril/valsartan', 'angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker therapy to sacubitril/valsartan']","['PNI scores', 'geriatric nutritional risk index (GNRI), controlling nutritional status (CONUT) score, prognostic nutritional index (PNI), and prealbumin', 'mortality and hospitalization', 'GNRI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003018', 'cui_str': 'Angiotensins'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}]","[{'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C4033631', 'cui_str': 'sacubitril / valsartan'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II Receptor Blockers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0033326', 'cui_str': 'Prognostic Nutritional Index (PNI)'}, {'cui': 'C0032923', 'cui_str': 'Transthyretin'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",164.0,0.0151827,"Also significant changes were observed at the baseline and follow-up in the mean scores of the three different nutritional indexes and prealbumin levels [CONUT: 2.68 ± 2.5, 1.02 ± 1.0 (P < 0.001); GNRI: 97.1 ± 9.7, 101.2 ± 5.9 (P < 0.001); PNI: 38.8 ± 4.8, 41.6 ± 3.7 (P < 0.001); prealbumin: 14.6 ± 6.9 mg/dl, 17.1 ± 5.2 mg/dl (P < 0.001)].","[{'ForeName': 'Seçkin', 'Initials': 'S', 'LastName': 'Dereli', 'Affiliation': 'Department of Cardiology, Ordu State Hospital.'}, {'ForeName': 'Adil', 'Initials': 'A', 'LastName': 'Bayramoğlu', 'Affiliation': 'Deparment of Cardiology, Ordu University Faculty of Medicine, Ordu, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Kaya', 'Affiliation': 'Deparment of Cardiology, Ordu University Faculty of Medicine, Ordu, Turkey.'}]","Journal of cardiovascular medicine (Hagerstown, Md.)",['10.2459/JCM.0000000000000895']
1612,28647848,The utilization of round window membrane surface tension in facilitating slim electrodes insertion during cochlear implantation.,"This is a prospective randomized study aimed to evaluate the round window membrane (RWM) surface tension in facilitating slim electrodes insertion during cochlear implantation. A total number of (118) children were included in this study (118 implantations). Mean age was 36.72 months (range from 18 to 60 months). This study was conducted from January 2015 to September 2016 at a cochlear implant centre in a tertiary referral hospital. Slit incision in the anterosuperior quadrant of the RWM was done in 70 cases, While RWM cruciate incision was done in 48 cases. Of the 48 patients who underwent RWM cruciate incision, 13 cases had no problem, while in 35 cases, we faced difficult insertion. When slit incision of the RWM was done (70 cases), 68 cases showed smooth insertion, meanwhile, we faced increased operative time due to flopping of the electrode in 2 cases only. Moreover, residual low-frequency hearing preservation was more achieved when slit incision of the RWM was done. Tensile strength of the round window membrane after slit incision of the RWM offers support to slim electrodes during introduction, decreasing incidence of kinking and floppiness, hence shortening the maneuver time and minimizing the number of trials. This facilitates easy smooth slim electrodes introduction, decreasing intracochlear trauma. Moreover, slit incision of the RWM may offer better residual hearing preservations than cruciate incision of the RWM during slim electrodes introduction.",2017,This is a prospective randomized study aimed to evaluate the round window membrane (RWM) surface tension in facilitating slim electrodes insertion during cochlear implantation.,"['A total number of (118) children were included in this study (118 implantations', 'January 2015 to September 2016 at a cochlear implant centre in a tertiary referral hospital', 'Mean age was 36.72\xa0months (range from 18 to 60\xa0months', '48 patients who underwent']","['RWM cruciate incision', 'Slit incision', 'round window membrane (RWM) surface tension']","['Tensile strength', 'operative time']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0009199', 'cui_str': 'Auditory Prosthesis'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0184904', 'cui_str': 'Slitting (procedure)'}, {'cui': 'C0035878', 'cui_str': 'Cochlear Round Window'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0038887', 'cui_str': 'Surface Tension'}]","[{'cui': 'C1540845', 'cui_str': 'Muscle tensile strength, function (observable entity)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}]",118.0,0.0268903,This is a prospective randomized study aimed to evaluate the round window membrane (RWM) surface tension in facilitating slim electrodes insertion during cochlear implantation.,"[{'ForeName': 'Ihab', 'Initials': 'I', 'LastName': 'Nada', 'Affiliation': 'Department of Otorhinolaryngology, Faculty of Medicine, Misr University for Science and Technology, 6th of October City, Egypt.'}, {'ForeName': 'Ahmed Nabil', 'Initials': 'AN', 'LastName': 'Abdelhamid', 'Affiliation': 'Department of Otorhinolaryngology, Faculty of Medicine, Ain Shams University, 6th Nile Valley Street, Hadayek Alkoba, Cairo, 11331, Egypt. ahnabilent@gmail.com.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Negm', 'Affiliation': 'Department of Otorhinolaryngology, Faculty of Medicine, Misr University for Science and Technology, 6th of October City, Egypt.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-017-4652-2']
1613,28685311,Comparing nasal packing with trans-septal suturing following septoplasty: a randomized clinical trial.,"It has been shown that nasal packing after septoplasty is associated with several complications. Our aim was to compare post-septoplasty nasal packing and trans-septal suturing, in terms of complications and outcome of operation. This randomized clinical trial was performed on patients with deviated nasal septum who were candidates for septoplasty. Patients were visited three times after operation (on the first 48 h, first week, and third post-operative month). Participants were checked for having common complications. Rhinomanometric evaluation was performed to measure nasal air flow and airway resistance, as indicators of operation efficacy, both prior to and after surgery. A total of 72 patients were allocated into the two trial arms. Patients in nasal pack group reported higher pain scores on the first 48 h (P < 0.001) and one week after surgery (P < 0.001). Epiphora (P = 0.028), sleep disturbance (P = 0.012), and dyspnea (P < 0.001) were also more commonly observed in patients using nasal pack. Objective evaluation of bleeding demonstrated that more severe bleeding occurred in patients with trans-septal sutures (P = 0.001). No differences were found comparing the indices of rhinomanometry between the two groups. Using trans-septal sutures after septoplasty compared to nasal packing, might be associated with lower frequencies of several specific complications and a lower rate of patients' discomfort. Nevertheless, increase in the risk of bleeding and hematoma was noted in the trans-septal suture group. No differences were observed between the nasal air flow and resistance of patients in the two groups.",2017,Patients in nasal pack group reported higher pain scores on the first 48 h (P < 0.001) and one week after surgery (P < 0.001).,"['A total of 72 patients', 'patients with deviated nasal septum who were candidates for septoplasty']","['nasal packing with trans-septal suturing following septoplasty', 'septoplasty nasal packing and trans-septal suturing']","['sleep disturbance', 'higher pain scores', 'severe bleeding', 'nasal air flow and airway resistance', 'risk of bleeding and hematoma', 'dyspnea', 'nasal air flow and resistance']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0549397', 'cui_str': 'Deviated nasal septum (disorder)'}, {'cui': 'C0844334', 'cui_str': 'Septoplasty'}]","[{'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0442004', 'cui_str': 'Septal (qualifier value)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0844334', 'cui_str': 'Septoplasty'}]","[{'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0429203', 'cui_str': 'Nasal air flow (observable entity)'}, {'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}]",72.0,0.0366881,Patients in nasal pack group reported higher pain scores on the first 48 h (P < 0.001) and one week after surgery (P < 0.001).,"[{'ForeName': 'Mohammadhossein', 'Initials': 'M', 'LastName': 'Dadgarnia', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Otorhinolaryngology Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Meybodian', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Otorhinolaryngology Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Akbar', 'Initials': 'A', 'LastName': 'Karbasi', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Otorhinolaryngology Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Mohammadhossein', 'Initials': 'M', 'LastName': 'Baradaranfar', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Otorhinolaryngology Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Atighechi', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Otorhinolaryngology Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Zand', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Otorhinolaryngology Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Sedighe', 'Initials': 'S', 'LastName': 'Vaziribozorg', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Otorhinolaryngology Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. s.vaziribozorg1408@gmail.com.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-017-4664-y']
1614,32412597,"Snacking on whole almonds for 6 weeks improves endothelial function and lowers LDL cholesterol but does not affect liver fat and other cardiometabolic risk factors in healthy adults: the ATTIS study, a randomized controlled trial.","BACKGROUND


There is convincing evidence that daily whole almond consumption lowers blood LDL cholesterol concentrations, but effects on other cardiometabolic risk factors such as endothelial function and liver fat are still to be determined.
OBJECTIVES


We aimed to investigate whether isoenergetic substitution of whole almonds for control snacks with the macronutrient profile of average snack intakes, had any impact on markers of cardiometabolic health in adults aged 30-70 y at above-average risk of cardiovascular disease (CVD).
METHODS


The study was a 6-wk randomized controlled, parallel-arm trial. Following a 2-wk run-in period consuming control snacks (mini-muffins), participants consumed either whole roasted almonds (n = 51) or control snacks (n = 56), providing 20% of daily estimated energy requirements. Endothelial function (flow-mediated dilation), liver fat (MRI/magnetic resonance spectroscopy), and secondary outcomes as markers of cardiometabolic disease risk were assessed at baseline and end point.
RESULTS


Almonds, compared with control, increased endothelium-dependent vasodilation (mean difference 4.1%-units of measurement; 95% CI: 2.2, 5.9), but there were no differences in liver fat between groups. Plasma LDL cholesterol concentrations decreased in the almond group relative to control (mean difference -0.25 mmol/L; 95% CI: -0.45, -0.04), but there were no group differences in triglycerides, HDL cholesterol, glucose, insulin, insulin resistance, leptin, adiponectin, resistin, liver function enzymes, fetuin-A, body composition, pancreatic fat, intramyocellular lipids, fecal SCFAs, blood pressure, or 24-h heart rate variability. However, the long-phase heart rate variability parameter, very-low-frequency power, was increased during nighttime following the almond treatment compared with control (mean difference 337 ms2; 95% CI: 12, 661), indicating greater parasympathetic regulation.
CONCLUSIONS


Whole almonds consumed as snacks markedly improve endothelial function, in addition to lowering LDL cholesterol, in adults with above-average risk of CVD.This trial was registered at clinicaltrials.gov as NCT02907684.",2020,"Plasma LDL cholesterol concentrations decreased in the almond group relative to control (mean difference -0.25 mmol/L; 95% CI: -0.45, -0.04), but there were no group differences in triglycerides, HDL cholesterol, glucose, insulin, insulin resistance, leptin, adiponectin, resistin, liver function enzymes, fetuin-A, body composition, pancreatic fat, intramyocellular lipids, fecal SCFAs, blood pressure, or 24-h heart rate variability.","['adults aged 30-70 y at above-average risk of cardiovascular disease (CVD', 'healthy adults']","['2-wk run-in period consuming control snacks (mini-muffins), participants consumed either whole roasted almonds (n\xa0=\xa051) or control snacks']","['liver fat', 'endothelial function', 'cardiometabolic health', 'blood LDL cholesterol concentrations', 'liver fat and other cardiometabolic risk factors', 'endothelial function and lowers LDL cholesterol', 'Endothelial function (flow-mediated dilation), liver fat (MRI/magnetic resonance spectroscopy', 'cardiometabolic disease risk', 'triglycerides, HDL cholesterol, glucose, insulin, insulin resistance, leptin, adiponectin, resistin, liver function enzymes, fetuin-A, body composition, pancreatic fat, intramyocellular lipids, fecal SCFAs, blood pressure, or 24-h heart rate variability', 'endothelium-dependent vasodilation', 'Plasma LDL cholesterol concentrations']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0452660', 'cui_str': 'Muffin'}, {'cui': 'C0440286', 'cui_str': 'Almond'}]","[{'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C1281905', 'cui_str': 'At risk of disease'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0963992', 'cui_str': 'Resistin'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0051477', 'cui_str': 'Alpha>2< hS glycoprotein'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C1278149', 'cui_str': 'Plasma LDL cholesterol measurement'}]",,0.564696,"Plasma LDL cholesterol concentrations decreased in the almond group relative to control (mean difference -0.25 mmol/L; 95% CI: -0.45, -0.04), but there were no group differences in triglycerides, HDL cholesterol, glucose, insulin, insulin resistance, leptin, adiponectin, resistin, liver function enzymes, fetuin-A, body composition, pancreatic fat, intramyocellular lipids, fecal SCFAs, blood pressure, or 24-h heart rate variability.","[{'ForeName': 'Vita', 'Initials': 'V', 'LastName': 'Dikariyanto', 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Smith', 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Francis', 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'May', 'Initials': 'M', 'LastName': 'Robertson', 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Eslem', 'Initials': 'E', 'LastName': 'Kusaslan', 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': ""O'Callaghan-Latham"", 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Palanche', 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': ""D'Annibale"", 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Dimitra', 'Initials': 'D', 'LastName': 'Christodoulou', 'Affiliation': ""Department of Radiology, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Basty', 'Affiliation': 'Research Centre for Optimal Health, School of Life Sciences, University of Westminster, London, UK.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Whitcher', 'Affiliation': 'Research Centre for Optimal Health, School of Life Sciences, University of Westminster, London, UK.'}, {'ForeName': 'Haris', 'Initials': 'H', 'LastName': 'Shuaib', 'Affiliation': ""Medical Physics, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Charles-Edwards', 'Affiliation': ""Medical Physics, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Chowienczyk', 'Affiliation': ""Department of Clinical Pharmacology, School of Cardiovascular Medicine and Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Ellis', 'Affiliation': ""Biopolymers Group, Departments of Biochemistry and Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Sarah E E', 'Initials': 'SEE', 'LastName': 'Berry', 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Wendy L', 'Initials': 'WL', 'LastName': 'Hall', 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa100']
1615,28669049,Endoscopic versus microscopic type 1 tympanoplasty in the same patients: a prospective randomized controlled trial.,"The aim of this study was to compare the audiologic outcomes of the patients who underwent endoscopy on one ear and microscopic tympanoplasty on the other, and to investigate the operative time, graft success, postoperative pain and health status. This prospective randomized controlled study was carried out in Ege University ENT Department between February 2015 and September 2016. The patients who had bilateral chronic otitis media, normal middle ear mucosa and a hearing loss difference of 10 dB or less between the two ears randomly underwent microscopic tympanoplasty in one ear and endoscopic tympanoplasty in the contralateral ear, with 6-month intervals. 13 patients were included in the study with a mean age of 36.17 ± 3.61 years (range 17-53 years, 7 female, 6 male). The improvement in air-bone gap for groups 1 (endoscopic) and 2 (microscopic) was 9.48 ± 5.23 and 9.89 ± 2.79 dB, respectively. The duration of the surgery in group 1 was significantly lower than that in group 2 (p < 0.01). VAS scores were 2.15 ± 0.37 and 3.76 ± 1.64 cm for groups 1 and 2, respectively (p = 0.006). The endoscopic approach for type 1 tympanoplasty offers shorter surgery time, better health status and lower postoperative pain than microscopic surgery. In addition, endoscopic surgery offers comparable improvement in air-bone gap and similar graft success. The endoscopic approach has comparable audiological and morphological graft outcomes with the microscopic one. The endoscopic approach yielded better health and pain status for the same patients. Level of evidence This is an individual randomized controlled trial. The level of evidence is 1b.",2017,The duration of the surgery in group 1 was significantly lower than that in group 2 (p < 0.01).,"['13 patients were included in the study with a mean age of 36.17\xa0±\xa03.61\xa0years (range 17-53\xa0years, 7 female, 6 male', 'patients who had bilateral chronic otitis media, normal middle ear mucosa and a hearing loss difference of 10\xa0dB or less between the two ears', 'patients who underwent endoscopy on one ear and microscopic tympanoplasty on the other', 'Ege University ENT Department between February 2015 and September 2016', 'same patients']","['endoscopic surgery', 'microscopic tympanoplasty', 'Endoscopic versus microscopic type 1 tympanoplasty']","['shorter surgery time, better health status and lower postoperative pain', 'air-bone gap and similar graft success', 'VAS scores', 'health and pain status', 'operative time, graft success, postoperative pain and health status', 'duration of the surgery', 'improvement in air-bone gap', 'audiologic outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0271441', 'cui_str': 'Chronic otitis media (disorder)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0013455', 'cui_str': 'Middle ear structure (body structure)'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0013443', 'cui_str': 'Vestibulocochlear Apparatus'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205288', 'cui_str': 'Microscopic (qualifier value)'}, {'cui': 'C0041447', 'cui_str': 'Tympanoplasty'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0587514', 'cui_str': 'Ear, nose and throat department (environment)'}]","[{'cui': 'C0282493', 'cui_str': 'Surgical Procedures, Endoscopic'}, {'cui': 'C0205288', 'cui_str': 'Microscopic (qualifier value)'}, {'cui': 'C0041447', 'cui_str': 'Tympanoplasty'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",13.0,0.0540229,The duration of the surgery in group 1 was significantly lower than that in group 2 (p < 0.01).,"[{'ForeName': 'Isa', 'Initials': 'I', 'LastName': 'Kaya', 'Affiliation': 'Otorhinolaryngology Department, Ege University School of Medicine, Tip Fakultesi, KBB Anabilim Dalı, Izmir, Turkey.'}, {'ForeName': 'Baha', 'Initials': 'B', 'LastName': 'Sezgin', 'Affiliation': 'Otorhinolaryngology Department, Ege University School of Medicine, Tip Fakultesi, KBB Anabilim Dalı, Izmir, Turkey. bahasezgin18@hotmail.com.'}, {'ForeName': 'Demet', 'Initials': 'D', 'LastName': 'Sergin', 'Affiliation': 'Anesthesiology and Reanimation Department, Ege University School of Medicine, Izmir, Turkey.'}, {'ForeName': 'Arin', 'Initials': 'A', 'LastName': 'Ozturk', 'Affiliation': 'Otorhinolaryngology Department, Ege University School of Medicine, Tip Fakultesi, KBB Anabilim Dalı, Izmir, Turkey.'}, {'ForeName': 'Sevinc', 'Initials': 'S', 'LastName': 'Eraslan', 'Affiliation': 'Otorhinolaryngology Department, Ege University School of Medicine, Tip Fakultesi, KBB Anabilim Dalı, Izmir, Turkey.'}, {'ForeName': 'Sercan', 'Initials': 'S', 'LastName': 'Gode', 'Affiliation': 'Otorhinolaryngology Department, Ege University School of Medicine, Tip Fakultesi, KBB Anabilim Dalı, Izmir, Turkey.'}, {'ForeName': 'Cem', 'Initials': 'C', 'LastName': 'Bilgen', 'Affiliation': 'Otorhinolaryngology Department, Ege University School of Medicine, Tip Fakultesi, KBB Anabilim Dalı, Izmir, Turkey.'}, {'ForeName': 'Tayfun', 'Initials': 'T', 'LastName': 'Kirazli', 'Affiliation': 'Otorhinolaryngology Department, Ege University School of Medicine, Tip Fakultesi, KBB Anabilim Dalı, Izmir, Turkey.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-017-4661-1']
1616,28623823,A randomized placebo-controlled trial of N-acetylcysteine for cannabis use disorder in adults.,"BACKGROUND


Cannabis use disorder (CUD) is a prevalent and impairing condition, and established psychosocial treatments convey limited efficacy. In light of recent findings supporting the efficacy of N-acetylcysteine (NAC) for CUD in adolescents, the objective of this trial was to evaluate its efficacy in adults.
METHODS


In a 12-week double-blind randomized placebo-controlled trial, treatment-seeking adults ages 18-50 with CUD (N=302), enrolled across six National Drug Abuse Treatment Clinical Trials Network-affiliated clinical sites, were randomized in a 1:1 ratio to a 12-week course of NAC 1200mg (n=153) or placebo (n=149) twice daily. All participants received contingency management (CM) and medical management. The primary efficacy measure was the odds of negative urine cannabinoid tests during treatment, compared between NAC and placebo participants.
RESULTS


There was not statistically significant evidence that the NAC and placebo groups differed in cannabis abstinence (odds ratio=1.00, 95% confidence interval 0.63-1.59, p=0.984). Overall, 22.3% of urine cannabinoid tests in the NAC group were negative, compared with 22.4% in the placebo group. Many participants were medication non-adherent; exploratory analysis within medication-adherent subgroups revealed no significant differential abstinence outcomes by treatment group.
CONCLUSIONS


In contrast with prior findings in adolescents, there is no evidence that NAC 1200mg twice daily plus CM is differentially efficacious for CUD in adults when compared to placebo plus CM. This discrepant finding between adolescents and adults with CUD may have been influenced by differences in development, cannabis use profiles, responses to embedded behavioral treatment, medication adherence, and other factors.",2017,"Many participants were medication non-adherent; exploratory analysis within medication-adherent subgroups revealed no significant differential abstinence outcomes by treatment group.
","['treatment-seeking adults ages 18-50 with CUD (N=302), enrolled across six National Drug Abuse Treatment Clinical Trials Network-affiliated clinical sites', 'cannabis use disorder in adults', 'adolescents and adults with CUD', 'adults']","['N-acetylcysteine (NAC', 'placebo', 'NAC 1200mg (n=153) or placebo', 'NAC', 'N-acetylcysteine', 'contingency management (CM) and medical management']","['odds of negative urine cannabinoid tests', 'cannabis abstinence']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0013146', 'cui_str': 'Drug abuse (disorder)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C0202349', 'cui_str': 'Cannabinoids measurement (procedure)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}]",,0.702752,"Many participants were medication non-adherent; exploratory analysis within medication-adherent subgroups revealed no significant differential abstinence outcomes by treatment group.
","[{'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Gray', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, United States. Electronic address: graykm@musc.edu.'}, {'ForeName': 'Susan C', 'Initials': 'SC', 'LastName': 'Sonne', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, United States. Electronic address: sonnesc@musc.edu.'}, {'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'McClure', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, United States. Electronic address: mccluree@musc.edu.'}, {'ForeName': 'Udi E', 'Initials': 'UE', 'LastName': 'Ghitza', 'Affiliation': 'National Institute on Drug Abuse Center for the Clinical Trials Network, Rockville, MD, United States. Electronic address: ghitzau@nida.nih.gov.'}, {'ForeName': 'Abigail G', 'Initials': 'AG', 'LastName': 'Matthews', 'Affiliation': 'The Emmes Corporation, Rockville, MD, United States. Electronic address: amatthews@emmes.com.'}, {'ForeName': 'Aimee L', 'Initials': 'AL', 'LastName': 'McRae-Clark', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, United States. Electronic address: mcraeal@musc.edu.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Carroll', 'Affiliation': 'Yale University, New Haven, CT, United States. Electronic address: kathleen.carroll@yale.edu.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Potter', 'Affiliation': 'University of Texas San Antonio, San Antonio, TX, United States. Electronic address: PotterJS@uthscsa.edu.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Wiest', 'Affiliation': 'CODA Inc., Portland, OR, United States. Electronic address: KatharinaWiest@codainc.org.'}, {'ForeName': 'Larissa J', 'Initials': 'LJ', 'LastName': 'Mooney', 'Affiliation': 'University of California Los Angeles, Los Angeles, CA, United States. Electronic address: lmooney@mednet.ucla.edu.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Hasson', 'Affiliation': 'University of California Los Angeles, Los Angeles, CA, United States. Electronic address: alhasson@ucla.edu.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Walsh', 'Affiliation': 'University of Kentucky, Lexington, KY, United States. Electronic address: sharon.walsh@uky.edu.'}, {'ForeName': 'Michelle R', 'Initials': 'MR', 'LastName': 'Lofwall', 'Affiliation': 'University of Kentucky, Lexington, KY, United States. Electronic address: michelle.lofwall@uky.edu.'}, {'ForeName': 'Shanna', 'Initials': 'S', 'LastName': 'Babalonis', 'Affiliation': 'University of Kentucky, Lexington, KY, United States. Electronic address: babalonis@uky.edu.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Lindblad', 'Affiliation': 'The Emmes Corporation, Rockville, MD, United States. Electronic address: rlindblad@emmes.com.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Sparenborg', 'Affiliation': 'National Institute on Drug Abuse Center for the Clinical Trials Network, Rockville, MD, United States. Electronic address: sparenborg@comcast.net.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Wahle', 'Affiliation': 'The Emmes Corporation, Rockville, MD, United States. Electronic address: awahle@emmes.com.'}, {'ForeName': 'Jacqueline S', 'Initials': 'JS', 'LastName': 'King', 'Affiliation': 'The Emmes Corporation, Rockville, MD, United States. Electronic address: jking@emmes.com.'}, {'ForeName': 'Nathaniel L', 'Initials': 'NL', 'LastName': 'Baker', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, United States. Electronic address: bakern@musc.edu.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Tomko', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, United States. Electronic address: tomko@musc.edu.'}, {'ForeName': 'Louise F', 'Initials': 'LF', 'LastName': 'Haynes', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, United States. Electronic address: hayneslf@musc.edu.'}, {'ForeName': 'Ryan G', 'Initials': 'RG', 'LastName': 'Vandrey', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, United States. Electronic address: rvandrey@jhmi.edu.'}, {'ForeName': 'Frances R', 'Initials': 'FR', 'LastName': 'Levin', 'Affiliation': 'Columbia University/New York State Psychiatric Institute, New York, NY, United States. Electronic address: frl2@cumc.columbia.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2017.04.020']
1617,28611230,Effect of a Motivational Interviewing-Based Health Coaching on Quality of Life in Subjects With COPD.,"BACKGROUND


Improving quality of life (QOL) is a key goal in the care of patients with COPD. Pulmonary rehabilitation (PR) has clearly been shown to improve QOL, but is not accessible to many eligible patients. There is a need for alternative programs designed to improve patient well-being that are accessible to all patients with COPD. Our goal was to pilot test a simple, telephone-based health-coaching intervention that was recently shown to decrease readmission among hospitalized COPD patients and stable COPD patients eligible for PR.
METHODS


Subjects received a 3-month intervention consisting of 10 health-coaching telephone calls based on motivational interviewing principles. Outcome measures included dyspnea level, measured by the modified Medical Research Council scale, and QOL, measured by the Chronic Respiratory Questionnaire and a single-item general self-rated health status.
RESULTS


Fifty subjects with moderate to severe COPD were enrolled in the study. Forty-four subjects (86%) completed the study intervention. Dyspnea measured by the modified Medical Research Council score improved significantly after the intervention ( P  = .002). The domains of fatigue, emotional function, and mastery on the Chronic Respiratory Disease Questionnaire and the single-item QOL question also improved significantly after the 3 months of health coaching ( P  = .001,  P  = .001,  P  = .007, and  P  = .03, respectively). Thirty-six (71%) subjects had a clinically meaningful improvement in at least 1 study end point (either in the severity of dyspnea or a domain of QOL). Thirty subjects (58%) had an improvement of ≥0.5 points, the minimum clinically important difference in at least 1 component of the Chronic Respiratory Disease Questionnaire.
CONCLUSIONS


A telephone-delivered motivational interviewing-based coaching program for COPD patients is a feasible, well-accepted (by both participants and providers), simple, and novel intervention to improve the well-being of patients with COPD. This pilot study provides insight into a possible alternative to a conventional PR program for patients with limited access to that program.",2017,"Thirty subjects (58%) had an improvement of ≥0.5 points, the minimum clinically important difference in at least 1 component of the Chronic Respiratory Disease Questionnaire.
","['patients with limited access to that program', 'Forty-four subjects (86%) completed the study intervention', 'hospitalized COPD patients and stable COPD patients eligible for PR', 'patients with COPD', 'Subjects With COPD', 'Fifty subjects with moderate to severe COPD', 'Subjects received a 3-month']","['intervention consisting of 10 health-coaching telephone calls based on motivational interviewing principles', 'telephone-based health-coaching intervention', 'Pulmonary rehabilitation (PR', 'telephone-delivered motivational interviewing-based coaching program', 'conventional PR program', 'Motivational Interviewing-Based Health Coaching']","['modified Medical Research Council score', 'Dyspnea', 'severity of dyspnea or a domain of QOL', 'Quality of Life', 'Chronic Respiratory Disease Questionnaire', 'fatigue, emotional function, and mastery on the Chronic Respiratory Disease Questionnaire and the single-item QOL question', 'dyspnea level, measured by the modified Medical Research Council scale, and QOL, measured by the Chronic Respiratory Questionnaire and a single-item general self-rated health status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C2317129', 'cui_str': 'Health coach'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation (regime/therapy)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0079816', 'cui_str': 'Medical Research'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0034380'}, {'cui': 'C3164900', 'cui_str': 'Chronic respiratory disease questionnaire (assessment scale)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}]",44.0,0.024575,"Thirty subjects (58%) had an improvement of ≥0.5 points, the minimum clinically important difference in at least 1 component of the Chronic Respiratory Disease Questionnaire.
","[{'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Rehman', 'Affiliation': 'Pulmonary Medicine, Mayo Clinic Health System, Austin, Minnesota.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Karpman', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Vickers Douglas', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Roberto P', 'Initials': 'RP', 'LastName': 'Benzo', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine benzo.roberto@mayo.edu.'}]",Respiratory care,['10.4187/respcare.04984']
1618,28623849,"Population Pharmacokinetics/Pharmacodynamics of 3,4-Diaminopyridine Free Base in Patients With Lambert-Eaton Myasthenia.","Lambert-Eaton myasthenia (LEM) is a rare autoimmune disorder associated with debilitating muscle weakness. There are limited treatment options and 3,4-diaminopyridine (3,4-DAP) free base is an investigational orphan drug used to treat LEM-related weakness. We performed a population pharmacokinetic/pharmacodynamic (PK/PD) analysis using 3,4-DAP and metabolite concentrations collected from a phase II study in patients with LEM. The Triple Timed Up & Go (3TUG) assessment, which measures lower extremity weakness, was the primary outcome measure. A total of 1,270 PK samples (49 patients) and 1,091 3TUG data points (32 randomized patients) were included in the PK/PD analysis. A two-compartment and one-compartment model for parent and metabolite, respectively, described the PK data well. Body weight and serum creatinine partially explained the variability in clearance for the final PK model. A fractional inhibitory maximum effect (E max  ) model characterized the exposure-response relationship well. The PK/PD model was applied to identify a suggested dosing approach for 3,4-DAP free base.",2017,"The Triple Timed Up & Go (3TUG) assessment, which measures lower extremity weakness, was the primary outcome measure.","['Patients With Lambert-Eaton Myasthenia', 'patients with LEM', 'A total of 1,270 PK samples (49 patients) and 1,091 3TUG data points (32 randomized patients) were included in the PK/PD analysis']","['Lambert-Eaton myasthenia (LEM', '3,4-Diaminopyridine', '3,4-diaminopyridine']",['Body weight and serum creatinine'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0947912'}, {'cui': 'C0115922', 'cui_str': 'leukocyte pyrogen'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0947912'}, {'cui': 'C0115922', 'cui_str': 'leukocyte pyrogen'}, {'cui': 'C0046948', 'cui_str': '3,4-Pyridinediamine'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}]",32.0,0.049487,"The Triple Timed Up & Go (3TUG) assessment, which measures lower extremity weakness, was the primary outcome measure.","[{'ForeName': 'Nilay', 'Initials': 'N', 'LastName': 'Thakkar', 'Affiliation': 'Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Guptill', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Aleš', 'Affiliation': 'Jacobus Pharmaceutical Company, Inc., Plainsboro, New Jersey, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jacobus', 'Affiliation': 'Jacobus Pharmaceutical Company, Inc., Plainsboro, New Jersey, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Jacobus', 'Affiliation': 'Jacobus Pharmaceutical Company, Inc., Plainsboro, New Jersey, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Peloquin', 'Affiliation': 'College of Pharmacy and Emerging Pathogens Institute, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cohen-Wolkowiez', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gonzalez', 'Affiliation': 'Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",CPT: pharmacometrics & systems pharmacology,['10.1002/psp4.12218']
1619,30677646,"Impact of pharmacogenomics on clinical outcomes in major depressive disorder in the GUIDED trial: A large, patient- and rater-blinded, randomized, controlled study.","Current prescribing practices for major depressive disorder (MDD) produce limited treatment success. Although pharmacogenomics may improve outcomes by identifying genetically inappropriate medications, studies to date were limited in scope. Outpatients (N = 1167) diagnosed with MDD and with a patient- or clinician-reported inadequate response to at least one antidepressant were enrolled in the Genomics Used to Improve DEpression Decisions (GUIDED) trial - a rater- and patient-blind randomized controlled trial. Patients were randomized to treatment as usual (TAU) or a pharmacogenomics-guided intervention arm in which clinicians had access to a pharmacogenomic test report to inform medication selections (guided-care). Medications were considered congruent ('use as directed' or 'use with caution' test categories) or incongruent ('use with increased caution and with more frequent monitoring' test category) with test results. Unblinding occurred after week 8. Primary outcome was symptom improvement [change in 17-item Hamilton Depression Rating Scale (HAM-D17)] at week 8; secondary outcomes were response (≥50% decrease in HAM-D17) and remission (HAM-D17 ≤ 7) at week 8. At week 8, symptom improvement for guided-care was not significantly different than TAU (27.2% versus 24.4%, p = 0.107); however, improvements in response (26.0% versus 19.9%, p = 0.013) and remission (15.3% versus 10.1%, p = 0.007) were statistically significant. Patients taking incongruent medications prior to baseline who switched to congruent medications by week 8 experienced greater symptom improvement (33.5% versus 21.1%, p = 0.002), response (28.5% versus 16.7%, p = 0.036), and remission (21.5% versus 8.5%, p = 0.007) compared to those remaining incongruent. Pharmacogenomic testing did not significantly improve mean symptoms but did significantly improve response and remission rates for difficult-to-treat depression patients over standard of care (ClinicalTrials.gov NCT02109939).",2019,Pharmacogenomic testing did not significantly improve mean symptoms but did significantly improve response and remission rates for difficult-to-treat depression patients over standard of care (ClinicalTrials.gov NCT02109939).,"['major depressive disorder', 'major depressive disorder (MDD', 'Outpatients (N\u202f=\u202f1167) diagnosed with MDD and with a patient- or clinician-reported inadequate response to at least one antidepressant were enrolled in the Genomics Used to Improve DEpression Decisions (GUIDED) trial - a rater- and patient-blind randomized controlled trial']",['usual (TAU) or a pharmacogenomics-guided intervention arm in which clinicians had access to a pharmacogenomic test report to inform medication selections (guided-care'],"['mean symptoms', 'symptom improvement [change in 17-item Hamilton Depression Rating Scale (HAM-D17', 'remission', 'HAM-D17) and remission', 'response and remission rates', 'symptom improvement', 'symptom improvement for guided-care']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0887950', 'cui_str': 'Genomics'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C1138555', 'cui_str': 'Pharmacogenomics'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C3853311', 'cui_str': 'Ham'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]",1167.0,0.16327,Pharmacogenomic testing did not significantly improve mean symptoms but did significantly improve response and remission rates for difficult-to-treat depression patients over standard of care (ClinicalTrials.gov NCT02109939).,"[{'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Greden', 'Affiliation': 'University of Michigan Department of Psychiatry and Comprehensive Depression Center 4250 Plymouth Rd, Ann Arbor, MI, 48109, USA. Electronic address: gredenj@med.umich.edu.'}, {'ForeName': 'Sagar V', 'Initials': 'SV', 'LastName': 'Parikh', 'Affiliation': 'University of Michigan Department of Psychiatry and Comprehensive Depression Center 4250 Plymouth Rd, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Rothschild', 'Affiliation': 'University of Massachusetts Medical School and UMass Memorial Healthcare, 55 N Lake Ave, Worcester, MA, 01655, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Perelman School of Medicine of the University of Pennsylvania and the Corporal Michael Crescenz VAMC, 3400 Civic Center Blvd, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Boadie W', 'Initials': 'BW', 'LastName': 'Dunlop', 'Affiliation': 'Emory University School of Medicine, Department of Psychiatry and Behavioral Sciences, 12 Executive Park Dr NE #200, Atlanta, GA, 30329, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'DeBattista', 'Affiliation': 'Stanford University School of Medicine, Department of Psychiatry and Behavioral Sciences, 401 Quarry Rd, Stanford, CA, 94305, USA.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Conway', 'Affiliation': ""Washington University School of Medicine, Department of Psychiatry, The John Cochran Veteran's Administration Hospital, 660 S Euclid Ave, St. Louis, MO, 63110, USA.""}, {'ForeName': 'Brent P', 'Initials': 'BP', 'LastName': 'Forester', 'Affiliation': 'McLean Hospital, Division of Geriatric Psychiatry, Harvard Medical School, 115 Mill St, Belmont, MA, 02478, USA.'}, {'ForeName': 'Francis M', 'Initials': 'FM', 'LastName': 'Mondimore', 'Affiliation': 'Johns Hopkins University School of Medicine, Department of Psychiatry and Behavioral Sciences, 1800 Orleans St, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'The University of Alabama at Birmingham, Department of Psychiatry and School of Medicine, 1720 2nd Ave S, Birmingham, AL, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Macaluso', 'Affiliation': 'University of Kansas School of Medicine-Wichita, Department of Psychiatry and Behavioral Sciences, 1010 N Kansas St, Wichita, KS, 67214, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Assurex Health, Inc., 6960 Cintas Blvd, Mason, OH, 45040, USA.'}, {'ForeName': 'Krystal', 'Initials': 'K', 'LastName': 'Brown', 'Affiliation': 'Myriad Genetics, Inc., 320 Wakara Way, Salt Lake City, UT, 84108, USA.'}, {'ForeName': 'Alexa', 'Initials': 'A', 'LastName': 'Gilbert', 'Affiliation': 'Assurex Health, Inc., 6960 Cintas Blvd, Mason, OH, 45040, USA.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Burns', 'Affiliation': 'Assurex Health, Inc., 6960 Cintas Blvd, Mason, OH, 45040, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Jablonski', 'Affiliation': 'Assurex Health, Inc., 6960 Cintas Blvd, Mason, OH, 45040, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Dechairo', 'Affiliation': 'Assurex Health, Inc., 6960 Cintas Blvd, Mason, OH, 45040, USA; Myriad Genetics, Inc., 320 Wakara Way, Salt Lake City, UT, 84108, USA.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2019.01.003']
1620,31591063,"Ramucirumab plus erlotinib in patients with untreated, EGFR-mutated, advanced non-small-cell lung cancer (RELAY): a randomised, double-blind, placebo-controlled, phase 3 trial.","BACKGROUND


Dual blockade of the EGFR and VEGF pathways in EGFR-mutated metastatic non-small-cell lung cancer (NSCLC) is supported by preclinical and clinical data, yet the approach is not widely implemented. RELAY assessed erlotinib, an EGFR tyrosine kinase inhibitor (TKI) standard of care, plus ramucirumab, a human IgG1 VEGFR2 antagonist, or placebo in patients with untreated EGFR-mutated metastatic NSCLC.
METHODS


This is a worldwide, double-blind, phase 3 trial done in 100 hospitals, clinics, and medical centres in 13 countries. Eligible patients were aged 18 years or older (20 years or older in Japan and Taiwan) at the time of study entry, had stage IV NSCLC, with an EGFR exon 19 deletion (ex19del) or exon 21 substitution (Leu858Arg) mutation, an Eastern Cooperative Oncology Group performance status of 0 or 1, and no CNS metastases. We randomly assigned eligible patients in a 1:1 ratio to receive oral erlotinib (150 mg/day) plus either intravenous ramucirumab (10 mg/kg) or matching placebo once every 2 weeks. Randomisation was done by an interactive web response system with a computer-generated sequence and stratified by sex, geographical region, EGFR mutation type, and EGFR testing method. The primary endpoint was investigator-assessed progression-free survival in the intention-to-treat population. Safety was assessed in all patients who received at least one dose of study treatment. This trial is registered at ClinicalTrials.gov, NCT02411448, and is ongoing for long-term survival follow-up.
FINDINGS


Between Jan 28, 2016, and Feb 1, 2018, 449 eligible patients were enrolled and randomly assigned to treatment with ramucirumab plus erlotinib (n=224) or placebo plus erlotinib (n=225). Median duration of follow-up was 20·7 months (IQR 15·8-27·2). At the time of primary analysis, progression-free survival was significantly longer in the ramucirumab plus erlotinib group (19·4 months [95% CI 15·4-21·6]) than in the placebo plus erlotinib group (12·4 months [11·0-13·5]), with a stratified hazard ratio of 0·59 (95% CI 0·46-0·76; p<0·0001). Grade 3-4 treatment-emergent adverse events were reported in 159 (72%) of 221 patients in the ramucirumab plus erlotinib group versus 121 (54%) of 225 in the placebo plus erlotinib group. The most common grade 3-4 treatment-emergent adverse events in the ramucirumab plus erlotinib group were hypertension (52 [24%]; grade 3 only) and dermatitis acneiform (33 [15%]), and in the placebo plus erlotinib group were dermatitis acneiform (20 [9%]) and increased alanine aminotransferase (17 [8%]). Treatment-emergent serious adverse events were reported in 65 (29%) of 221 patients in the ramucirumab plus erlotinib group and 47 (21%) of 225 in the placebo plus erlotinib group. The most common serious adverse events of any grade in the ramucirumab plus erlotinib group were pneumonia (seven [3%]) and cellulitis and pneumothorax (four [2%], each); the most common in the placebo plus erlotinib group were pyrexia (four [2%]) and pneumothorax (three [1%]). One on-study treatment-related death due to an adverse event occurred (haemothorax after a thoracic drainage procedure for a pleural empyema) in the ramucirumab plus erlotinib group.
INTERPRETATION


Ramucirumab plus erlotinib demonstrated superior progression-free survival compared with placebo plus erlotinib in patients with untreated EGFR-mutated metastatic NSCLC. Safety was consistent with the safety profiles of the individual compounds in advanced lung cancer. The RELAY regimen is a viable new treatment option for the initial treatment of EGFR-mutated metastatic NSCLC.
FUNDING


Eli Lilly.",2019,Grade 3-4 treatment-emergent adverse events were reported in 159 (72%) of 221 patients in the ramucirumab plus erlotinib group versus 121 (54%) of 225 in the placebo plus erlotinib group.,"['Eligible patients were aged 18 years or older (20 years or older in Japan and Taiwan) at the time of study entry, had stage IV NSCLC, with an EGFR exon 19 deletion (ex19del) or exon 21 substitution (Leu858Arg) mutation, an Eastern Cooperative Oncology Group performance status of 0 or 1, and no CNS metastases', 'patients with untreated, EGFR-mutated, advanced non-small-cell lung cancer (RELAY', 'Between Jan 28, 2016, and Feb 1, 2018, 449 eligible patients', '100 hospitals, clinics, and medical centres in 13 countries', 'advanced lung cancer', 'patients with untreated EGFR-mutated metastatic NSCLC']","['ramucirumab plus erlotinib', 'matching placebo', 'Ramucirumab plus erlotinib', 'placebo', 'placebo plus erlotinib', 'oral erlotinib', 'intravenous ramucirumab']","['pneumothorax', 'Grade 3-4 treatment-emergent adverse events', 'investigator-assessed progression-free survival', 'cellulitis and pneumothorax', 'Safety', 'progression-free survival', 'alanine aminotransferase', 'pyrexia', 'dermatitis acneiform', 'superior progression-free survival', 'hypertension', 'Median duration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C3889117', 'cui_str': 'EGFR exon 19 deletion'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C4524268', 'cui_str': 'Advanced lung cancer'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer (disorder)'}]","[{'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0007642', 'cui_str': 'Cellulitis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0234894', 'cui_str': 'Dermatitis acneiform'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",449.0,0.561056,Grade 3-4 treatment-emergent adverse events were reported in 159 (72%) of 221 patients in the ramucirumab plus erlotinib group versus 121 (54%) of 225 in the placebo plus erlotinib group.,"[{'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan. Electronic address: nakagawa@med.kindai.ac.jp.'}, {'ForeName': 'Edward B', 'Initials': 'EB', 'LastName': 'Garon', 'Affiliation': 'David Geffen School of Medicine at University of California Los Angeles, Translational Research in Oncology US Network, Los Angeles, CA, USA.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Seto', 'Affiliation': 'National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Nishio', 'Affiliation': 'Department of Thoracic Medical Oncology, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Ponce Aix', 'Affiliation': 'Hospital Universitario 12 de Octubre, H12O-CNIO Lung Cancer Clinical Research Unit, Universidad Complutense and Ciberonc, Madrid, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Paz-Ares', 'Affiliation': 'Hospital Universitario 12 de Octubre, H12O-CNIO Lung Cancer Clinical Research Unit, Universidad Complutense and Ciberonc, Madrid, Spain.'}, {'ForeName': 'Chao-Hua', 'Initials': 'CH', 'LastName': 'Chiu', 'Affiliation': 'Department of Chest Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Keunchil', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Division of Hematology and Oncology, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Novello', 'Affiliation': 'Department of Oncology, University of Turin, Azienda ospedaliero-universitaria San Luigi, Orbassano, Italy.'}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Nadal', 'Affiliation': ""Department of Medical Oncology, Catalan Institute of Oncology, and Clinical Research in Solid Tumors group, Oncobell, l'Institut d'Investigació Biomèdica de Bellvitge, L'Hospitalet, Barcelona, Spain.""}, {'ForeName': 'Fumio', 'Initials': 'F', 'LastName': 'Imamura', 'Affiliation': 'Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Kiyotaka', 'Initials': 'K', 'LastName': 'Yoh', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Jin-Yuan', 'Initials': 'JY', 'LastName': 'Shih', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Kwok Hung', 'Initials': 'KH', 'LastName': 'Au', 'Affiliation': 'Queen Elizabeth Hospital, Kowloon, Hong Kong.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Moro-Sibilot', 'Affiliation': 'Grenoble University Hospital, Grenoble, France.'}, {'ForeName': 'Sotaro', 'Initials': 'S', 'LastName': 'Enatsu', 'Affiliation': 'Eli Lilly Japan KK Kobe, Kobe, Japan.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Zimmermann', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Frimodt-Moller', 'Affiliation': 'Eli Lilly and Company, Copenhagen, Denmark.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Visseren-Grul', 'Affiliation': 'Lilly Oncology, Utrecht, Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'LungenClinic, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30634-5']
1621,32010236,Khorana score and thromboembolic risk in stage II-III colorectal cancer patients: a  post hoc  analysis from the adjuvant TOSCA trial.,"Background


The risk of venous thromboembolic events (VTE) during adjuvant chemotherapy for colorectal cancer (CRC) is unknown. We aim to evaluate if the Khorana score (KS) can predict this risk, and if it represents a prognostic factor for overall survival (OS) through a  post hoc  analysis of the phase III TOSCA trial of different durations (3-  versus  6-months) of adjuvant chemotherapy.
Methods


A logistic regression model was used to test the associations between the risk of VTE and the KS. The results are expressed as odds ratios (OR) with 95% confidence intervals (95% CI). To assess the effect of the KS on OS, multivariable analyses using Cox regression models were performed. The results are expressed as hazard ratios (HR) with 95% CI.
Results


Among 1380 CRC patients with available data, the VTE risk ( n  = 72 events: 5.2%) was similar in the two duration arms (5.5%  versus  4.9%), with 0.2% of patients belonging to the high-risk KS group. Rates of VTE were similar in the low- and intermediate-risk groups (4.8%  versus  6.4%). KS did not represent an independent predictive factor for VTE occurrence. Chemotherapy duration was not associated with VTE risk. In addition, KS was not prognostic for OS in multivariate analysis (HR: 0.92, 95% CI, 0.63-1.36;  p  = 0.6835).
Conclusions


The use of the KS did not predict VTEs in a low-moderate thromboembolic risk population as CRC. These data did not support the use of KS to predict VTE during adjuvant chemotherapy, and suggest that other risk assessment models should be researched.",2020,"In addition, KS was not prognostic for OS in multivariate analysis (HR: 0.92, 95% CI, 0.63-1.36;  p  = 0.6835).
","['stage II-III colorectal cancer patients', 'colorectal cancer (CRC', '1380 CRC patients with available data']","['KS', 'Khorana score (KS', 'adjuvant chemotherapy']","['hazard ratios (HR', 'risk of venous thromboembolic events (VTE', 'Rates of VTE', 'Khorana score and thromboembolic risk']","[{'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0630906', 'cui_str': 'triethoxyvinylsilane'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",1380.0,0.128844,"In addition, KS was not prognostic for OS in multivariate analysis (HR: 0.92, 95% CI, 0.63-1.36;  p  = 0.6835).
","[{'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Barni', 'Affiliation': 'Oncology Unit, Medical Science Department, ASST Bergamo Ovest, Treviglio (BG), Italy.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Rosati', 'Affiliation': 'Medical Oncology Unit, Ospedale San Carlo, Potenza, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Medical Oncology Unit 1, Istituto Oncologico Veneto-IRCCS, Padova, Italy.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Pella', 'Affiliation': 'Medical Oncology Unit, Azienda Ospedaliero Universitaria Santa Maria della Misericordia, Udine, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Banzi', 'Affiliation': 'Medical Oncology Unit, Arcispedale Santa Maria Nuova-IRCCS, Reggio Emilia, Italy.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Zampino', 'Affiliation': 'Gastrointestinal Medical Oncology Unit and Neuroendocrine Tumors, Istituto Europeo di Oncologia-IRCCS, Milano, Italy.'}, {'ForeName': 'Katia F', 'Initials': 'KF', 'LastName': 'Dotti', 'Affiliation': 'Medical Oncology Unit, Fondazione Istituto Nazionale Tumori-IRCCS, Milano, Italy.'}, {'ForeName': 'Lorenza', 'Initials': 'L', 'LastName': 'Rimassa', 'Affiliation': 'Medical Oncology and Hematology Unit, Humanitas Cancer Center, Humanitas Clinical and Research Center, Rozzano (MI), Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Marchetti', 'Affiliation': ""Medical Oncology Unit, Sant'Andrea Hospital, Sapienza University of Rome and IDI-IRCCS, Roma, Italy.""}, {'ForeName': 'Evaristo', 'Initials': 'E', 'LastName': 'Maiello', 'Affiliation': 'Medical Oncology Unit, Hospital Casa Sollievo della Sofferenza-IRCCS, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Artioli', 'Affiliation': 'Medical Oncology Unit Ramazzini Hospital, Carpi (MO), Italy.'}, {'ForeName': 'Daris', 'Initials': 'D', 'LastName': 'Ferrari', 'Affiliation': 'Medical Oncology Unit, Azienda Ospedaliera San Paolo, Milano, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Labianca', 'Affiliation': 'Cancer Center ASST Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Bidoli', 'Affiliation': 'Medical Oncology Unit San Gerardo dei Tintori Hospital, Monza, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zaniboni', 'Affiliation': 'Medical Oncology Unit, Fondazione Poliambulanza, Brescia, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Sobrero', 'Affiliation': 'Medical Oncology Unit, IRCCS San Martino-IST, Genova, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Iaffaioli', 'Affiliation': 'Abdominal Medical Oncology, National Cancer Institute, IRCCS Foundation Pascale, Napoli, Italy.'}, {'ForeName': 'Sabino', 'Initials': 'S', 'LastName': 'De Placido', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University, Napoli, Italy.'}, {'ForeName': 'Gian Luca', 'Initials': 'GL', 'LastName': 'Frassineti', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRST, IRCCS, Meldola, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ciarlo', 'Affiliation': 'Medical Oncology Unit, Prato Hospital, Prato, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Buonadonna', 'Affiliation': 'Medical Oncology Unit Centro di Riferimento Oncologico Aviano-IRCCS, Aviano, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Silvestris', 'Affiliation': ""Medical Oncology Unit Ospedale Oncologico 'Giovanni Paolo II' and Scientific Directorate-IRCCS, Bari, Italy.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Piazza', 'Affiliation': 'Medical Oncology Unit AOU Sacco Hospital, Milano, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Pavesi', 'Affiliation': 'Medical Oncology Unit Fondazione Maugeri-IRCCS, Pavia, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Moroni', 'Affiliation': 'Medical Oncology Unit AO San Carlo Borromeo, Milano, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Clerico', 'Affiliation': 'Medical Oncology Department ASL Biella, Biella, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Aglietta', 'Affiliation': 'Candiolo Cancer Institute FPO-IRCCS, Candiolo, Italy, Department of Oncology, University of Torino, Torino, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Giordani', 'Affiliation': 'Medical Oncology Unit AO Ospedali Riuniti Marche Nord, Pesaro, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Galli', 'Affiliation': 'Laboratory of Methodology for Clinical Research, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Galli', 'Affiliation': 'Laboratory of Methodology for Clinical Research, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Fausto', 'Initials': 'F', 'LastName': 'Petrelli', 'Affiliation': 'Oncology Unit, Medical Science Department, ASST Bergamo Ovest, Piazzale Ospedale 1, Treviglio (BG), 24047, Italy.'}]",Therapeutic advances in medical oncology,['10.1177/1758835919899850']
1622,28540514,The effectiveness of myringotomy and ventilation tube insertion versus observation in post-radiation otitis media with effusion.,"To compare the effectiveness of myringotomy and ventilation tube insertion versus observation in post-radiation otitis media with effusion (OME) in nasopharyngeal carcinoma (NPC). NPC patients who finished radiotherapy and had persistent OME were randomized to myringotomy and ventilation tube insertion and observation groups. The resolution rate of OME and hearing outcomes were evaluated. Forty three patients (23 in control group and 20 in intervention group) were analyzed. One patient in the control group obtained a resolution of OME. The remaining patients in the control group had persistent middle ear fluid. Fourteen patients in the intervention group had retained ventilation tubes without otorrhea. Ventilation tubes had spontaneously extruded in the remaining six patients and all of these patients had recurrent OME. Mean air-pure tone average in the control group was 52.04 dB (SD 11.61), significantly different from the intervention group [38.15 dB (SD 19.10); p = 0.01]. Mean air-bone gap in the control and intervention groups were 27.30 dB (SD 9.11) and 9.30 dB (SD 9.59) respectively (p < 0.001). Mean air-pure tone average and mean air-bone gap improvement was significantly improved in the intervention group (p < 0.001). Two patients in the intervention group (10%) developed complications, one patient suffering suppurative otitis media whilst another had otorrhea, which resolved after 1-week course of antibiotic treatment. Post-radiation OME is common in patients with NPC and tends to persist long-term. Conservative management is safe, however, is plagued by frustrating effects of hearing impairment and aural fullness. Myringotomy with ventilation tube insertion leads to hearing improvement with few complications.",2017,Mean air-pure tone average and mean air-bone gap improvement was significantly improved in the intervention group (p < 0.001).,"['post-radiation otitis media with effusion', 'patients with NPC', 'post-radiation otitis media with effusion (OME) in nasopharyngeal carcinoma (NPC', 'NPC patients who finished radiotherapy and had persistent OME']","['myringotomy and ventilation tube insertion', 'Myringotomy with ventilation tube insertion', 'myringotomy and ventilation tube insertion versus observation']","['resolution of OME', 'resolution rate of OME and hearing outcomes', 'recurrent OME', 'retained ventilation tubes without otorrhea', 'persistent middle ear fluid', 'Mean air-bone gap', 'complications, one patient suffering suppurative otitis media whilst another had otorrhea', 'Mean air-pure tone average and mean air-bone gap improvement', 'Mean air-pure tone average']","[{'cui': 'C0445177', 'cui_str': 'Post-radiation (qualifier value)'}, {'cui': 'C0029883', 'cui_str': 'Otitis Media, Secretory'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma (disorder)'}, {'cui': 'C1706059', 'cui_str': 'Finish - dosing instruction imperative'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0087123', 'cui_str': 'Myringostomy'}, {'cui': 'C0850121', 'cui_str': 'Ventilation tube'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0850121', 'cui_str': 'Ventilation tube'}, {'cui': 'C0155540', 'cui_str': 'Otorrhea (disorder)'}, {'cui': 'C4319764', 'cui_str': 'Middle ear fluid'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029888', 'cui_str': 'Otitis Media, Purulent'}]",43.0,0.0438222,Mean air-pure tone average and mean air-bone gap improvement was significantly improved in the intervention group (p < 0.001).,"[{'ForeName': 'Paninee', 'Initials': 'P', 'LastName': 'Charusripan', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Faculty of Medicine, Chulalongkorn University, 1873 Rama 4 Road, Pathumwan, Bangkok, 10330, Thailand. paninee.ent@gmail.com.'}, {'ForeName': 'Likhit', 'Initials': 'L', 'LastName': 'Khattiyawittayakun', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Faculty of Medicine, Chulalongkorn University, 1873 Rama 4 Road, Pathumwan, Bangkok, 10330, Thailand.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-017-4617-5']
1623,31813281,Baseline Characteristics of the VANISH Cohort.,"BACKGROUND


The VANISH trial (Valsartan for Attenuating Disease Evolution in Early Sarcomeric Hypertrophic Cardiomyopathy) targeted young sarcomeric gene mutation carriers with early-stage hypertrophic cardiomyopathy (HCM) to test whether valsartan can modify disease progression. We describe the baseline characteristics of the VANISH cohort and compare to previous trials evaluating angiotensin receptor blockers.
METHODS


Applying a randomized, double-blinded, placebo-controlled design, 178 participants with nonobstructive HCM (age, 23.3±10.1 years; 61% men) were randomized in the primary cohort and 34 (age, 16.5±4.9 years; 50% men) in the exploratory cohort of sarcomeric mutation carriers without left ventricular hypertrophy.
RESULTS


In the primary cohort, maximal left ventricular wall thickness was 17±4 mm for adults and  Z  score 7.0±4.5 for children. Nineteen percent had late gadolinium enhancement on cardiac magnetic resonance. Mean peak oxygen consumption was 33 mL/kg per minute, and 92% of participants were New York Heart Association functional class I. New York Heart Association class II was associated with older age,  MYH7  variants, and more prominent imaging abnormalities. Six previous trials of angiotensin receptor blockers in HCM enrolled a median of 24 patients (range, 19-133) with mean age of 51.2 years; 42% of patients were in New York Heart Association class ≥II, and sarcomeric mutations were not required.
CONCLUSIONS


The VANISH cohort is much larger, younger, less heterogeneous, and has less advanced disease than prior angiotensin receptor blocker trials in HCM. Participants had relatively normal functional capacity and mild HCM features. New York Heart Association functional class II symptoms were associated with older age, more prominent imaging abnormalities, and  MYH7  variants, suggesting both phenotype and genotype contribute to disease manifestations.
CLINICAL TRIAL REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT01912534.",2019,"New York Heart Association functional class II symptoms were associated with older age, more prominent imaging abnormalities, and  MYH7  variants, suggesting both phenotype and genotype contribute to disease manifestations.
","['HCM enrolled a median of 24 patients (range, 19-133) with mean age of 51.2 years; 42% of patients were in New York Heart Association class ≥II, and sarcomeric mutations were not required', '178 participants with nonobstructive HCM (age, 23.3±10.1 years; 61% men) were randomized in the primary cohort and 34 (age, 16.5±4.9 years; 50% men) in the exploratory cohort of sarcomeric mutation carriers without left ventricular hypertrophy']","['placebo', 'valsartan', 'angiotensin receptor blockers', 'VANISH trial (Valsartan']","['maximal left ventricular wall thickness', 'late gadolinium enhancement on cardiac magnetic resonance', 'normal functional capacity and mild HCM features', 'Mean peak oxygen consumption']","[{'cui': 'C0007194', 'cui_str': 'Hypertrophic cardiomyopathy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0340425', 'cui_str': 'Hypertrophic cardiomyopathy without obstruction'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0340279', 'cui_str': 'Ventricular hypertrophy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0007194', 'cui_str': 'Hypertrophic cardiomyopathy'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}]",178.0,0.398618,"New York Heart Association functional class II symptoms were associated with older age, more prominent imaging abnormalities, and  MYH7  variants, suggesting both phenotype and genotype contribute to disease manifestations.
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Axelsson Raja', 'Affiliation': 'Copenhagen University Hospital Rigshospitalet, Denmark (A.A.R., H.B.).'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'New England Research Institutes, Watertown, MA (L.S.).'}, {'ForeName': 'Sharlene M', 'Initials': 'SM', 'LastName': 'Day', 'Affiliation': 'University of Michigan, Ann Arbor (S.M.D., M.R.).'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Russell', 'Affiliation': 'University of Michigan, Ann Arbor (S.M.D., M.R.).'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Zahka', 'Affiliation': 'Cleveland Clinic, OH (K.Z., H.L.).'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Lever', 'Affiliation': 'Cleveland Clinic, OH (K.Z., H.L.).'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Colan', 'Affiliation': ""Boston Children's Hospital, MA (S.D.C., R.M.).""}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Margossian', 'Affiliation': ""Boston Children's Hospital, MA (S.D.C., R.M.).""}, {'ForeName': 'E Kevin', 'Initials': 'EK', 'LastName': 'Hall', 'Affiliation': 'Yale University, New Haven, CT (E.K.H.).'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Becker', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN (J.B.).'}, {'ForeName': 'John Lynn', 'Initials': 'JL', 'LastName': 'Jefferies', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, OH (J.L.J.).""}, {'ForeName': 'Amit R', 'Initials': 'AR', 'LastName': 'Patel', 'Affiliation': 'University of Chicago, IL (A.R.P.).'}, {'ForeName': 'Lubna', 'Initials': 'L', 'LastName': 'Choudhury', 'Affiliation': 'Northwestern University, Chicago, IL (L.C.).'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Murphy', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD (A.M.M.).'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Canter', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO (C.C., R.B.).'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bach', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO (C.C., R.B.).'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Taylor', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora (M.T., L.M.).'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Mestroni', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora (M.T., L.M.).'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Wheeler', 'Affiliation': 'Stanford University School of Medicine, Palo Alto, CA (M.T.W.).'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Benson', 'Affiliation': 'Toronto Hospital for Sick Children, ON, Canada (L.B.).'}, {'ForeName': 'Anjali T', 'Initials': 'AT', 'LastName': 'Owens', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine, Philadelphia (A.T.O.).'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Rossano', 'Affiliation': ""Children's Hospital of Philadelphia, PA (J.R., K.Y.L.).""}, {'ForeName': 'Kimberly Y', 'Initials': 'KY', 'LastName': 'Lin', 'Affiliation': ""Children's Hospital of Philadelphia, PA (J.R., K.Y.L.).""}, {'ForeName': 'Elfriede', 'Initials': 'E', 'LastName': 'Pahl', 'Affiliation': ""Ann & Robert H. Lurie Children's Hospital of Chicago, IL (E.P.).""}, {'ForeName': 'Alexandre C', 'Initials': 'AC', 'LastName': 'Pereira', 'Affiliation': 'Heart Institute, University of São Paulo Medical School (Instituto do Coração), Brazil (A.C.P.).'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Bundgaard', 'Affiliation': 'Copenhagen University Hospital Rigshospitalet, Denmark (A.A.R., H.B.).'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Lewis', 'Affiliation': 'Massachusetts General Hospital, Boston (G.D.L.).'}, {'ForeName': 'Jose D', 'Initials': 'JD', 'LastName': 'Vargas', 'Affiliation': 'MedStar Georgetown University Hospital, National Institutes of Health, Bethesda, MD (J.D.V.).'}, {'ForeName': 'Allison L', 'Initials': 'AL', 'LastName': 'Cirino', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA (A.L.C., C.A.M., S.D.S., E.J.O., E.B., C.Y.H.).""}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'University of Glasgow, Glasgow, UK (J.J.V.M.).'}, {'ForeName': 'Calum A', 'Initials': 'CA', 'LastName': 'MacRae', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA (A.L.C., C.A.M., S.D.S., E.J.O., E.B., C.Y.H.).""}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA (A.L.C., C.A.M., S.D.S., E.J.O., E.B., C.Y.H.).""}, {'ForeName': 'E John', 'Initials': 'EJ', 'LastName': 'Orav', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA (A.L.C., C.A.M., S.D.S., E.J.O., E.B., C.Y.H.).""}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA (A.L.C., C.A.M., S.D.S., E.J.O., E.B., C.Y.H.).""}, {'ForeName': 'Carolyn Y', 'Initials': 'CY', 'LastName': 'Ho', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA (A.L.C., C.A.M., S.D.S., E.J.O., E.B., C.Y.H.).""}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.119.006231']
1624,31575336,Different preprocessing strategies lead to different conclusions: A [ 11 C]DASB-PET reproducibility study.,"Positron emission tomography (PET) neuroimaging provides unique possibilities to study biological processes in vivo under basal and interventional conditions. For quantification of PET data, researchers commonly apply different arrays of sequential data analytic methods (""preprocessing pipeline""), but it is often unknown how the choice of preprocessing affects the final outcome. Here, we use an available data set from a double-blind, randomized, placebo-controlled [ 11 C]DASB-PET study as a case to evaluate how the choice of preprocessing affects the outcome of the study. We tested the impact of 384 commonly used preprocessing strategies on a previously reported positive association between the change from baseline in neocortical serotonin transporter binding determined with [ 11 C]DASB-PET, and change in depressive symptoms, following a pharmacological sex hormone manipulation intervention in 30 women. The two preprocessing steps that were most critical for the outcome were motion correction and kinetic modeling of the dynamic PET data. We found that 36% of the applied preprocessing strategies replicated the originally reported finding ( p  < 0.05). For preprocessing strategies with motion correction, the replication percentage was 72%, whereas it was 0% for strategies without motion correction. In conclusion, the choice of preprocessing strategy can have a major impact on a study outcome.",2019,"For preprocessing strategies with motion correction, the replication percentage was 72%, whereas it was 0% for strategies without motion correction.",['30 women'],"['placebo', 'Positron emission tomography (PET', 'pharmacological sex hormone manipulation intervention']","['replication percentage', 'motion correction and kinetic modeling of the dynamic PET data']","[{'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0036884', 'cui_str': 'Gonadal Steroid Hormones'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}]","[{'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}]",384.0,0.255819,"For preprocessing strategies with motion correction, the replication percentage was 72%, whereas it was 0% for strategies without motion correction.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Nørgaard', 'Affiliation': 'Neurobiology Research Unit, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Ganz', 'Affiliation': 'Neurobiology Research Unit, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Svarer', 'Affiliation': 'Neurobiology Research Unit, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Vibe G', 'Initials': 'VG', 'LastName': 'Frokjaer', 'Affiliation': 'Neurobiology Research Unit, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Douglas N', 'Initials': 'DN', 'LastName': 'Greve', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Strother', 'Affiliation': 'Rotman Research Institute, Baycrest, Department of Medical Biophysics, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Gitte M', 'Initials': 'GM', 'LastName': 'Knudsen', 'Affiliation': 'Neurobiology Research Unit, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}]",Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism,['10.1177/0271678X19880450']
1625,28352966,Cold Blooded: Evaluating Brain Temperature by MRI During Surface Cooling of Human Subjects.,"BACKGROUND


Targeted temperature management (TTM) confers neurological and survival benefits for post-cardiac arrest patients with return of spontaneous circulation (ROSC) who remain comatose. Specialized equipment for induction of hypothermia is not available in the prehospital setting, and there are no reliable methods for emergency medical services personnel to initiate TTM. We hypothesized that the application of surface cooling elements to the neck will decrease brain temperature and act as initiators of TTM.
METHODS


Magnetic resonance (MR) spectroscopy was used to evaluate the effect of a carotid surface cooling element on brain temperature in healthy adults.
RESULTS


Six individuals completed this study. We measured a temperature drop of 0.69 ± 0.38 °C (95% CI) in the cortex of the brain following the application of the cooling element. Application of a room temperature element also caused a measurable decrease in brain temperature of 0.66 ± 0.41 °C (95% CI) which may be attributable to baroreceptor activation.
CONCLUSION


The application of surface cooling elements to the neck decreased brain temperature and may serve as a method to initiate TTM in the prehospital setting.",2017,"Application of a room temperature element also caused a measurable decrease in brain temperature of 0.66 ± 0.41 °C (95% CI) which may be attributable to baroreceptor activation.
","['post-cardiac arrest patients with return of spontaneous circulation (ROSC) who remain comatose', 'healthy adults', 'Human Subjects']","['Targeted temperature management (TTM', 'MRI', 'carotid surface cooling element']",['brain temperature'],"[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0009421', 'cui_str': 'Comatose'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C0020674', 'cui_str': 'Targeted Temperature Management'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0013879', 'cui_str': 'Elements'}]","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}]",,0.0629607,"Application of a room temperature element also caused a measurable decrease in brain temperature of 0.66 ± 0.41 °C (95% CI) which may be attributable to baroreceptor activation.
","[{'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Curran', 'Affiliation': 'Department of Surgery, The Robert Larner, M.D. College of Medicine at The University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Wolfson', 'Affiliation': 'Department of Surgery, The Robert Larner, M.D. College of Medicine at The University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Watts', 'Affiliation': 'Department of Radiology, The Robert Larner, M.D. College of Medicine at The University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Kalev', 'Initials': 'K', 'LastName': 'Freeman', 'Affiliation': 'Department of Surgery, The Robert Larner, M.D. College of Medicine at The University of Vermont, Burlington, VT, USA. kalev.freeman@uvm.edu.'}]",Neurocritical care,['10.1007/s12028-017-0389-4']
1626,31752969,Delivery of home-based postpartum contraception in rural Guatemalan women: a cluster-randomized trial protocol.,"BACKGROUND


Postpartum contraception is important to prevent unintended and closely spaced pregnancies following childbirth.
METHODS


This study is a cluster-randomized trial of communities in rural Guatemala where women receive ante- and postnatal care through a community-based nursing program. When nurses visit women for their postpartum visit in the intervention clusters, instead of providing only routine care that includes postpartum contraceptive education and counseling, the nurses will also bring a range of barrier, short-acting, and long-acting contraceptives that will be offered and administered in the home setting, after routine clinical care is provided.
DISCUSSION


A barrier to postpartum contraception is access to medications and devices. Our study removes some access barriers (distance, time, cost) by providing contraception in the home. We also trained community nurses to place implants, which are a type of long-acting reversible contraceptive method that was previously only available in the closest town which is about an hour away by vehicular travel. Therefore, our study examines how home-based delivery of routinely available contraceptives and the less routinely available implant may be associated with increased uptake of postpartum contraception within 3 months of childbirth. The potential implications of this study include that nurses may be able to be trained to safely provide contraceptives, including placing implants, in the home setting, and provision of home-based contraception may be an effective way of delivering an evidence-based intervention for preventing unintended and closely spaced pregnancies in the postpartum period.
TRIAL REGISTRATION


Clinicaltrials.gov, NCT04005391. Retrospectively registered on 1 July 2019.",2019,"When nurses visit women for their postpartum visit in the intervention clusters, instead of providing only routine care that includes postpartum contraceptive education and counseling, the nurses will also bring a range of barrier, short-acting, and long-acting contraceptives that will be offered and administered in the home setting, after routine clinical care is provided.
","['communities in rural Guatemala where women receive ante- and postnatal care through a community-based nursing program', 'rural Guatemalan women']",['home-based postpartum contraception'],[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0032782', 'cui_str': 'Postpartum Care'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0700589', 'cui_str': 'Fertility Control'}]",[],,0.184952,"When nurses visit women for their postpartum visit in the intervention clusters, instead of providing only routine care that includes postpartum contraceptive education and counseling, the nurses will also bring a range of barrier, short-acting, and long-acting contraceptives that will be offered and administered in the home setting, after routine clinical care is provided.
","[{'ForeName': 'Margo S', 'Initials': 'MS', 'LastName': 'Harrison', 'Affiliation': 'University of Colorado, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, Denver, CO, 80045, USA. margo.harrison@ucdenver.edu.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Bunge-Montes', 'Affiliation': 'Fundación para la Salud Integral de los Guatemaltecos (FSIG), Quetzaltenango, Guatemala.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Rivera', 'Affiliation': 'Fundación para la Salud Integral de los Guatemaltecos (FSIG), Quetzaltenango, Guatemala.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Jimenez-Zambrano', 'Affiliation': 'University of Colorado, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, Denver, CO, 80045, USA.'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Heinrichs', 'Affiliation': 'Denver Health, Denver, CO, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Scarbro', 'Affiliation': 'University of Colorado, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, Denver, CO, 80045, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Juarez-Colunga', 'Affiliation': 'University of Colorado, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, Denver, CO, 80045, USA.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Bolanos', 'Affiliation': 'Fundación para la Salud Integral de los Guatemaltecos (FSIG), Quetzaltenango, Guatemala.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Asturias', 'Affiliation': 'University of Colorado, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, Denver, CO, 80045, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Berman', 'Affiliation': 'University of Colorado, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, Denver, CO, 80045, USA.'}, {'ForeName': 'Jeanelle', 'Initials': 'J', 'LastName': 'Sheeder', 'Affiliation': 'University of Colorado, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, Denver, CO, 80045, USA.'}]",Trials,['10.1186/s13063-019-3735-3']
1627,31433483,Cost-effectiveness of Housing First Intervention With Intensive Case Management Compared With Treatment as Usual for Homeless Adults With Mental Illness: Secondary Analysis of a Randomized Clinical Trial.,"Importance


In the At Home/Chez Soi trial for homeless individuals with mental illness, the scattered-site Housing First (HF) with Intensive Case Management (ICM) intervention proved more effective than treatment as usual (TAU).
Objective


To evaluate the cost-effectiveness of the HF plus ICM intervention compared with TAU.
Design, Setting, and Participants


This is an economic evaluation study of data from the At Home/Chez Soi randomized clinical trial. From October 2009 through July 2011, 1198 individuals were randomized to the intervention (n = 689) or TAU (n = 509) and followed up for as long as 24 months. Participants were recruited in the Canadian cities of Vancouver, Winnipeg, Toronto, and Montreal. Participants with a current mental disorder who were homeless and had a moderate level of need were included. Data were analyzed from 2013 through 2019, per protocol.
Interventions


Scattered-site HF (using rent supplements) with off-site ICM services was compared with usual housing and support services in each city.
Main Outcomes and Measures


The analysis was performed from the perspective of society, with days of stable housing as the outcome. Service use was ascertained using questionnaires. Unit costs were estimated in 2016 Canadian dollars.
Results


Of 1198 randomized individuals, 795 (66.4%) were men and 696 (58.1%) were aged 30 to 49 years. Almost all (1160 participants, including 677 in the HF group and 483 in the TAU group) contributed data to the economic analysis. Days of stable housing were higher by 140.34 days (95% CI, 128.14-153.31 days) in the HF group. The intervention cost $14 496 per person per year; reductions in costs of other services brought the net cost down by 46% to $7868 (95% CI, $4409-$11 405). The incremental cost-effectiveness ratio was $56.08 (95% CI, $29.55-$84.78) per additional day of stable housing. In sensitivity analyses, adjusting for baseline differences using a regression-based method, without altering the discount rate, caused the largest change in the incremental cost-effectiveness ratio with an increase to $60.18 (95% CI, $35.27-$86.95). At $67 per day of stable housing, there was an 80% chance that HF was cost-effective compared with TAU. The cost-effectiveness of HF appeared to be similar for all participants, although possibly less for those with a higher number of previous psychiatric hospitalizations.
Conclusions and Relevance


In this study, the cost per additional day of stable housing was similar to that of many interventions for homeless individuals. Based on these results, expanding access to HF with ICM appears to be warranted from an economic standpoint.
Trial Registration


isrctn.org Identifier: ISRCTN42520374.",2019,"Days of stable housing were higher by 140.34 days (95% CI, 128.14-153.31 days) in the HF group.","['homeless individuals', 'Participants were recruited in the Canadian cities of Vancouver, Winnipeg, Toronto, and Montreal', '1198 randomized individuals, 795 (66.4%) were men and 696 (58.1%) were aged 30 to 49 years', 'Homeless Adults With Mental Illness', 'From October 2009 through July 2011, 1198 individuals', '1160 participants, including 677 in the HF group and 483 in the TAU group) contributed data to the economic analysis', 'homeless individuals with mental illness', 'Participants with a current mental disorder who were homeless and had a moderate level of need were included']","['HF plus ICM intervention', 'Housing First Intervention With Intensive Case Management', 'Intensive Case Management (ICM) intervention', 'TAU']","['Cost-effectiveness', 'incremental cost-effectiveness ratio', 'Unit costs', 'cost-effectiveness of HF', 'cost-effectiveness']","[{'cui': 'C0237154', 'cui_str': 'Homelessness'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0020056', 'cui_str': 'Housing'}, {'cui': 'C0085971', 'cui_str': 'Case Management'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",1198.0,0.202438,"Days of stable housing were higher by 140.34 days (95% CI, 128.14-153.31 days) in the HF group.","[{'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Latimer', 'Affiliation': 'Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rabouin', 'Affiliation': 'Douglas Research Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Zhirong', 'Initials': 'Z', 'LastName': 'Cao', 'Affiliation': 'Douglas Research Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Ly', 'Affiliation': 'Montreal West Island Integrated University Health and Social Services Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Powell', 'Affiliation': 'Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Carol E', 'Initials': 'CE', 'LastName': 'Adair', 'Affiliation': 'Department of Psychiatry, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Jitender', 'Initials': 'J', 'LastName': 'Sareen', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Julian M', 'Initials': 'JM', 'LastName': 'Somers', 'Affiliation': 'Faculty of Health Sciences, Simon Fraser University, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Stergiopoulos', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Pinto', 'Affiliation': 'Department of Family and Community Medicine, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Erica E M', 'Initials': 'EEM', 'LastName': 'Moodie', 'Affiliation': 'Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Scott R', 'Initials': 'SR', 'LastName': 'Veldhuizen', 'Affiliation': 'Centre for Addiction and Mental Health, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA network open,['10.1001/jamanetworkopen.2019.9782']
1628,31474354,"Niraparib plus bevacizumab versus niraparib alone for platinum-sensitive recurrent ovarian cancer (NSGO-AVANOVA2/ENGOT-ov24): a randomised, phase 2, superiority trial.","BACKGROUND


Platinum-based chemotherapy is the foundation of treatment for platinum-sensitive recurrent ovarian cancer, but has substantial toxicity. Bevacizumab and maintenance poly(ADP-ribose) polymerase (PARP) inhibitors both significantly improve efficacy versus standard therapy, primarily in terms of progression-free survival, and offer the potential for chemotherapy-free treatment. AVANOVA2 compared niraparib and bevacizumab versus niraparib alone as definitive treatment for platinum-sensitive recurrent ovarian cancer.
METHODS


This open-label, randomised, phase 2, superiority trial in 15 university hospitals in Denmark, Sweden, Finland, Norway, and the USA enrolled women aged 18 years or older with measurable or evaluable high-grade serous or endometrioid platinum-sensitive recurrent ovarian cancer. Patients had to have an Eastern Cooperative Oncology Group performance status of 0-2, and had to have previously received platinum-containing therapy for primary disease but ≤1 prior non-platinum-containing regimen for recurrent disease. Previous treatment with bevacizumab or first-line maintenance PARP inhibitors was permitted. Eligible patients were randomly assigned 1:1 (by random permuted blocks with block sizes of two and four, no masking), stratified by homologous recombination deficiency status and chemotherapy-free interval, to receive once-daily oral niraparib 300 mg alone or with intravenous bevacizumab 15 mg/kg once every 3 weeks until disease progression. The primary endpoint was progression-free survival, assessed by the investigators in the intention-to-treat population after events in at least 62 patients. Safety was analysed in all patients who received at least one dose of study drug. This ongoing trial is registered with ClinicalTrials.gov, number NCT02354131.
FINDINGS


Between May 23, 2016, and March 6, 2017, 97 patients were enrolled and randomly assigned: 48 to niraparib plus bevacizumab and 49 to single-agent niraparib. Median follow-up was 16·9 months (IQR 15·4-20·9). Niraparib plus bevacizumab significantly improved progression-free survival compared with niraparib alone (median progression-free survival 11·9 months [95% CI 8·5-16·7] vs 5·5 months [3·8-6·3], respectively; adjusted hazard ratio [HR] 0·35 [95% CI 0·21-0·57], p<0·0001). Grade 3 or worse adverse events occurred in 31 (65%) of 48 patients who received niraparib plus bevacizumab and 22 (45%) of 49 who received single-agent niraparib. The most common grade 3 or worse adverse events in both groups were anaemia (7 [15%] of 48 vs 9 [18%] of 49) and thrombocytopenia (5 [10%] vs 6 [12%]), and hypertension in the combination group (10 [21%] vs 0). Niraparib plus bevacizumab was associated with increased incidences of any-grade proteinuria (10 [21%] of 48 patients vs 0) and hypertension (27 [56%] of 48 vs 11 [22%] of 49) compared with niraparib alone. No treatment-related deaths occurred.
INTERPRETATION


The efficacy observed with this chemotherapy-free combination of approved agents in women with platinum-sensitive recurrent ovarian cancer warrants further evaluation. A randomised phase 3 trial investigating niraparib plus bevacizumab versus chemotherapy plus bevacizumab in platinum-sensitive recurrent ovarian cancer is planned.
FUNDING


Nordic Society of Gynaecological Oncology and Tesaro.",2019,Niraparib plus bevacizumab significantly improved progression-free survival compared with niraparib alone (median progression-free survival 11·9 months,"['platinum-sensitive recurrent ovarian cancer', 'Eligible patients', 'Between May 23, 2016, and March 6, 2017, 97 patients were enrolled and randomly assigned: 48 to', 'Patients had to have an Eastern Cooperative Oncology Group performance status of 0-2, and had to have previously received platinum-containing therapy for primary disease but ≤1 prior non-platinum-containing regimen for recurrent disease', 'women with platinum-sensitive recurrent ovarian cancer', '15 university hospitals in Denmark, Sweden, Finland, Norway, and the USA enrolled women aged 18 years or older with measurable or evaluable high-grade serous or endometrioid platinum-sensitive recurrent ovarian cancer', 'platinum-sensitive recurrent ovarian cancer (NSGO-AVANOVA2/ENGOT-ov24']","['niraparib alone', 'bevacizumab', 'Niraparib plus bevacizumab', 'niraparib and bevacizumab', 'block sizes of two and four, no masking), stratified by homologous recombination deficiency status and chemotherapy-free interval, to receive once-daily oral niraparib 300 mg alone or with intravenous bevacizumab', 'AVANOVA2', 'Bevacizumab and maintenance poly(ADP-ribose) polymerase (PARP) inhibitors', 'Platinum-based chemotherapy', 'niraparib plus bevacizumab', 'chemotherapy plus bevacizumab']","['Grade 3 or worse adverse events', 'adverse events', 'progression-free survival', 'incidences of any-grade proteinuria', 'thrombocytopenia', 'hypertension', 'anaemia', 'Safety']","[{'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0277556', 'cui_str': 'Recurrent disease (disorder)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0440743', 'cui_str': 'Serous (qualifier value)'}]","[{'cui': 'C2744440', 'cui_str': 'niraparib'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0599773', 'cui_str': 'Homologous Recombination'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1882413', 'cui_str': 'PARP Inhibitors'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",97.0,0.32479,Niraparib plus bevacizumab significantly improved progression-free survival compared with niraparib alone (median progression-free survival 11·9 months,"[{'ForeName': 'Mansoor Raza', 'Initials': 'MR', 'LastName': 'Mirza', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. Electronic address: mansoor.raza.mirza@regionh.dk.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Åvall Lundqvist', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Department of Oncology, Linköping University, Linköping, Sweden; Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Birrer', 'Affiliation': ""O'Neal Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, AL, USA.""}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'dePont Christensen', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Research Unit of General Practice University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Gitte-Bettina', 'Initials': 'GB', 'LastName': 'Nyvang', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Malander', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Lund University Hospital, Lund, Sweden.'}, {'ForeName': 'Maarit', 'Initials': 'M', 'LastName': 'Anttila', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Theresa L', 'Initials': 'TL', 'LastName': 'Werner', 'Affiliation': 'University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Lund', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Lindahl', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Department of Oncology, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Sakari', 'Initials': 'S', 'LastName': 'Hietanen', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Peen', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Herlev University Hospital, Herlev, Denmark.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Dimoula', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Sahlgrenska University Hospital, Göteborg, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Roed', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Ør Knudsen', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Synnöve', 'Initials': 'S', 'LastName': 'Staff', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Department of Obstetrics and Gynecology and Tays Cancer Centre, Faculty of Medicine and Health Technology, Tampere University and University Hospital, Tampere, Finland.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Krog Vistisen', 'Affiliation': 'Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Bjørge', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Department of Obstetrics and Gynecology, Haukeland University Hospital, Bergen, Norway; Center for Cancer Biomarkers CCBIO, Department of Clinical Science, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Johanna U', 'Initials': 'JU', 'LastName': 'Mäenpää', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Department of Obstetrics and Gynecology and Tays Cancer Centre, Faculty of Medicine and Health Technology, Tampere University and University Hospital, Tampere, Finland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30515-7']
1629,32492131,Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis for Low Rectal Cancer: A Randomized Clinical Trial.,"Importance


Two-stage Turnbull-Cutait pull-through hand-sewn coloanal anastomosis seems to provide benefits in terms of postoperative morbidity compared with standard hand-sewn coloanal anastomosis associated with diverting ileostomy and further ileostomy reversal in patients operated on for low rectal cancer.
Objective


To compare 30-day postoperative and 1-year follow-up results of Turnbull-Cutait pull-through hand-sewn coloanal anastomosis and standard hand-sewn coloanal anastomosis after ultralow rectal resection for rectal cancer.
Design, Setting, and Participants


Multicenter randomized clinical trial. Neither patients nor surgeons were blinded for technique. Patients were recruited in 3 centers, Bellvitge University Hospital and Valle d'Hebron University Hospital in Spain and Instituto Nazionale Tumori Fondazione G. Pascale-Istituto di Ricovero e Cura a Carattere Scientifico in Italy. Patients undergoing ultralow anterior rectal resection needing hand-sewn coloanal anastomosis were randomly assigned to 2-stage Turnbull-Cutait pull-through hand-sewn coloanal anastomosis or standard hand-sewn coloanal anastomosis associated with diverting ileostomy. Data were analyzed between June 2012 and October 2018.
Interventions


All patients underwent ultralow anterior resection. Patients assigned to the 2-stage Turnbull-Cutait pull-through group underwent exteriorization of a segment of left colon through the anal canal and, after 6 to 10 days, the exteriorized colon was resected and a delayed hand-sewn coloanal anastomosis was performed. For patients assigned to standard coloanal anastomosis, the hand-sewn coloanal anastomosis was performed with diverting ileostomy at first operation. Closure of the ileostomy was planned after 6 to 8 months.
Main Outcomes and Measures


Primary outcome was 30-day postoperative morbidity. For the standard hand-sewn coloanal anastomosis with diverting ileostomy group, overall postoperative morbidity includes 30-day postoperative complications of the ileostomy closure.
Results


Ninety-two white patients, 72 men and 20 women, with a median age of 62 years, were randomized and included in the analysis. Forty-six patients received standard hand-sewn coloanal anastomosis with diverting ileostomy and 46 received the 2-stage pull-through hand-sewn coloanal anastomosis. Seven patients (15.2%) in the standard hand-sewn coloanal anastomosis group did not undergo reversal ileostomy, and 1 patient (2.2%) in the 2-stage pull-through hand-sewn coloanal anastomosis group did not undergo delayed coloanal anastomosis. The 30-day overall composite postoperative complications rate was similar between the 2 groups (34.8% in 2-stage pull-through hand-sewn coloanal anastomosis group vs 45.7% in standard hand-sewn coloanal anastomosis group; P = .40), with a difference of -10.9 (95% CI, -29.5 to 8.9).
Conclusions and Relevance


The 2-stage pull-through hand-sewn coloanal anastomosis after ultralow anterior resection for low rectal cancer is safe and does not increase the postoperative morbidity rate compared with standard coloanal anastomosis with covering ileostomy followed by ileostomy closure.
Trial Registration


ClinicalTrials.gov Identifier: NCT01766661.",2020,"The 30-day overall composite postoperative complications rate was similar between the 2 groups (34.8% in 2-stage pull-through hand-sewn coloanal anastomosis group vs 45.7% in standard hand-sewn coloanal anastomosis group; P = .40), with a difference of -10.9 (95% CI, -29.5 to 8.9).
","['Patients undergoing ultralow anterior rectal resection needing hand-sewn coloanal anastomosis', 'Low Rectal Cancer', 'Ninety-two white patients, 72 men and 20 women, with a median age of 62 years', ""Patients were recruited in 3 centers, Bellvitge University Hospital and Valle d'Hebron University Hospital in Spain and Instituto Nazionale Tumori Fondazione G. Pascale-Istituto di Ricovero""]","['standard coloanal anastomosis, the hand-sewn coloanal anastomosis was performed with diverting ileostomy at first operation', 'Turnbull-Cutait pull-through hand-sewn coloanal anastomosis and standard hand-sewn coloanal anastomosis after ultralow rectal resection', '2-stage Turnbull-Cutait pull-through hand-sewn coloanal anastomosis or standard hand-sewn coloanal anastomosis associated with diverting ileostomy', 'standard hand-sewn coloanal anastomosis with diverting ileostomy and 46 received the 2-stage pull-through hand-sewn coloanal anastomosis', 'ultralow anterior resection', '2-stage Turnbull-Cutait pull-through group underwent exteriorization of a segment of left colon through the anal canal', 'Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis']","['30-day postoperative morbidity', '30-day overall composite postoperative complications rate', 'postoperative morbidity rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0193062', 'cui_str': 'Resection of rectum'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0020883', 'cui_str': 'Creation of ileostomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}, {'cui': 'C0193062', 'cui_str': 'Resection of rectum'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0185000', 'cui_str': 'Exteriorization - action'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0227388', 'cui_str': 'Left colon structure'}, {'cui': 'C0227411', 'cui_str': 'Anal canal structure'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",92.0,0.128528,"The 30-day overall composite postoperative complications rate was similar between the 2 groups (34.8% in 2-stage pull-through hand-sewn coloanal anastomosis group vs 45.7% in standard hand-sewn coloanal anastomosis group; P = .40), with a difference of -10.9 (95% CI, -29.5 to 8.9).
","[{'ForeName': 'Sebastiano', 'Initials': 'S', 'LastName': 'Biondo', 'Affiliation': 'Colorectal Unit, IDIBELL, Bellvitge University Hospital, Department of General and Digestive Surgery, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Loris', 'Initials': 'L', 'LastName': 'Trenti', 'Affiliation': 'Colorectal Unit, IDIBELL, Bellvitge University Hospital, Department of General and Digestive Surgery, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Eloy', 'Initials': 'E', 'LastName': 'Espin', 'Affiliation': ""Colorectal Unit, Vall d'Hebron University Hospital, Department of General and Digestive Surgery, Autonomic University of Barcelona, Barcelona, Spain.""}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bianco', 'Affiliation': 'General and Colorectal Surgery Unit, S. Leonardo Hospital/ASL-Na3-sud, Castellammare di Stabia, Naples, Italy.'}, {'ForeName': 'Oriana', 'Initials': 'O', 'LastName': 'Barrios', 'Affiliation': 'Colorectal Unit, IDIBELL, Bellvitge University Hospital, Department of General and Digestive Surgery, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Falato', 'Affiliation': 'General Surgery Unit, S. Giuliano Hospital, Giugliano, Naples, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'De Franciscis', 'Affiliation': 'Colorectal Cancer Surgery Unit, Istituto Nazionale Tumori di Napoli, Istituto di Ricovero e Cura a Carattere Scientifico, Naples, Italy.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Solis', 'Affiliation': ""Colorectal Unit, Vall d'Hebron University Hospital, Department of General and Digestive Surgery, Autonomic University of Barcelona, Barcelona, Spain.""}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Kreisler', 'Affiliation': 'Colorectal Unit, IDIBELL, Bellvitge University Hospital, Department of General and Digestive Surgery, University of Barcelona, Barcelona, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA surgery,['10.1001/jamasurg.2020.1625']
1630,31847536,Improved clinical outcomes among persons with HIV who quit smoking.,"Quitting smoking among people living with HIV/AIDS (PLWHA) is a priority. However, PLWHA and clinicians working with PLWHA are reluctant to use tobacco use treatments out of concern that smoking cessation can diminish anti-retroviral therapy (ART) adherence and quality of life (QoL) and increase psychiatric symptoms. This secondary analysis from a placebo-controlled varenicline trial for tobacco dependence among PLWHA ( N  = 179) examined if smoking cessation at the end of treatment (EOT) was associated with changes in ART adherence, QoL, anxiety and depression symptoms, and varenicline side effects. ART adherence was not affected by smoking cessation ( p  > 0.05), remaining ≥98% for all participants. Across 8 QoL subscales, 7 remained unchanged over time across smokers and abstainers; side effects were not associated with cessation. Controlling for baseline smoking rate, adherence to varenicline/placebo and counseling, and treatment arm, participants who had quit smoking at EOT reported a significant reduction in depression ( β  = -1.657, 95% CI: -2.893, -0.422,  p  = .009) and anxiety ( β  = -1.434, 95% CI: -2.812, -0.56,  p  = .041) and increased life satisfaction ( β  = 0.88, 95% CI: 0.21, 3.275,  p  = .027). When PLWHA quit smoking they may not experience adverse clinical outcomes including ART non-adherence and may experience beneficial psychological effects, supporting the use of FDA-approved smoking cessation treatments among PLWHA.",2019,"ART adherence was not affected by smoking cessation ( p  > 0.05), remaining ≥98% for all participants.","['persons with HIV who quit smoking', 'people living with HIV/AIDS (PLWHA']","['placebo-controlled varenicline', 'varenicline/placebo']","['anti-retroviral therapy (ART) adherence and quality of life (QoL) and increase psychiatric symptoms', 'life satisfaction', 'Quitting smoking', 'anxiety', 'ART adherence, QoL, anxiety and depression symptoms, and varenicline side effects', 'depression', 'ART adherence']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0034380'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom (finding)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",8.0,0.131834,"ART adherence was not affected by smoking cessation ( p  > 0.05), remaining ≥98% for all participants.","[{'ForeName': 'Su Fen', 'Initials': 'SF', 'LastName': 'Lubitz', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Flitter', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Ashare', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Thompson', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Leone', 'Affiliation': 'Pulmonary, Allergy, & Critical Care Division, University of Pennsylvania Presbyterian Medical Center, Philadelphia, PA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gross', 'Affiliation': 'Division of Infectious Diseases, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Schnoll', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}]",AIDS care,['10.1080/09540121.2019.1703891']
1631,31578887,"Phacoemulsification, visco-goniosynechialysis, and goniotomy in patients with primary angle-closure glaucoma: A comparative study.","OBJECTIVE


The aim of this study was to evaluate the effects of goniotomy on patients with primary angle-closure glaucoma who underwent ""phacoemulsification and visco-goniosynechialysis.""
MATERIALS AND METHODS


This prospective randomized clinical trial was carried out on 63 eyes of 61 patients (48-85 years) with primary angle-closure glaucoma who were enrolled. The subjects were randomly assigned into two groups. In the first group (32 eyes) and the second group (31 eyes), the patients underwent ""phacoemulsification + visco-goniosynechialysis + goniotomy"" and ""phacoemulsification + visco-goniosynechialysis,"" respectively. Intraocular pressure and antiglaucoma medication were evaluated (1 week, as well as 1, 3, and 6 months after the surgery). Anterior segment optical coherence tomography parameters (Casia, Tomey, USA) and goniotomy were evaluated preoperatively and 6 months after the surgery.
RESULTS


The mean intraocular pressure lowering the effects in the ""phacoemulsification + visco-goniosynechialysis + goniotomy"" group was higher than that in the ""phacoemulsification + visco-goniosynechialysis"" group (6.93 and 4.6, respectively). Furthermore, the difference in intraocular pressure between the two groups was significant at 3 months (P = 0.014) and 6 months (P = 0.021) after the surgery. There was no difference in anterior segment optical coherence tomography findings before the intervention; however, after the intervention, the anterior segment optical coherence tomography indices were significantly different between the two groups. Moreover, the difference in ""phacoemulsification + visco-goniosynechialysis + goniotomy"" indices was more than the changes in the ""phacoemulsification + visco-goniosynechialysis"" group.
CONCLUSION


The results of this study showed that phacoemulsification + visco-goniosynechialysis + goniotomy is a more effective surgery than phacoemulsification + visco-goniosynechialysis alone in undercounted primary angle-closure glaucoma.",2019,"Furthermore, the difference in intraocular pressure between the two groups was significant at 3 months (P = 0.014) and 6 months (P = 0.021) after the surgery.","['63 eyes of 61 patients (48-85\u2009years) with primary angle-closure glaucoma who were enrolled', 'patients with primary angle-closure glaucoma who underwent', 'patients with primary angle-closure glaucoma']","['phacoemulsification\u2009+\u2009visco-goniosynechialysis\u2009+\u2009goniotomy"" and ""phacoemulsification\u2009+\u2009visco-goniosynechialysis,"" respectively', 'phacoemulsification\u2009+\u2009visco-goniosynechialysis', 'Phacoemulsification, visco-goniosynechialysis, and goniotomy', 'goniotomy', 'phacoemulsification and visco-goniosynechialysis']","['anterior segment optical coherence tomography findings', 'mean intraocular pressure', 'Anterior segment optical coherence tomography parameters (Casia, Tomey, USA) and goniotomy', 'anterior segment optical coherence tomography indices', 'Intraocular pressure and antiglaucoma medication', 'intraocular pressure']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0017606', 'cui_str': 'Primary angle-closure glaucoma (disorder)'}]","[{'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0018072', 'cui_str': 'Goniotomy'}]","[{'cui': 'C0348014', 'cui_str': 'Anterior segment (qualifier value)'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018072', 'cui_str': 'Goniotomy'}]",,0.0253345,"Furthermore, the difference in intraocular pressure between the two groups was significant at 3 months (P = 0.014) and 6 months (P = 0.021) after the surgery.","[{'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Shokoohi-Rad', 'Affiliation': 'Department of Ophthalmology, Eye Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Farshid', 'Initials': 'F', 'LastName': 'Karimi', 'Affiliation': 'Department of Optometry, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Siamak', 'Initials': 'S', 'LastName': 'Zarei-Ghanavati', 'Affiliation': 'Department of Ophthalmology, Eye Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Tireh', 'Affiliation': 'Department of Epidemiology and Biostatistics, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",European journal of ophthalmology,['10.1177/1120672119879331']
1632,30943843,"Overall mortality in men and women in the randomized Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial.",,2019,"In women, no reduction was seen in either overall mortality (age-adjusted rate ratio = 1.002) or OM EX  (age-adjusted rate ratio = 1.006).","['76,678 men and 78,209 women randomized, with median follow-up of 17 years']","['annual chest radiographs and two sigmoidoscopy exams', 'annual CA125 tests and trans-vaginal ultrasounds']","['overall mortality excluding trial cancer deaths', 'overall mortality and overall mortality excluding deaths', 'Overall mortality', 'overall mortality']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C1306645', 'cui_str': 'Plain x-ray'}, {'cui': 'C0037075', 'cui_str': 'Proctosigmoidoscopy'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.133952,"In women, no reduction was seen in either overall mortality (age-adjusted rate ratio = 1.002) or OM EX  (age-adjusted rate ratio = 1.006).","[{'ForeName': 'Paul F', 'Initials': 'PF', 'LastName': 'Pinsky', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, NIH, Bethesda, USA.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Miller', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, NIH, Bethesda, USA.'}, {'ForeName': 'Claire S', 'Initials': 'CS', 'LastName': 'Zhu', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, NIH, Bethesda, USA.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Prorok', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, NIH, Bethesda, USA.'}]",Journal of medical screening,['10.1177/0969141319839097']
1633,31578095,Impact of resistance training sets performed until muscular failure with different loads on intraocular pressure and ocular perfusion pressure.,"PURPOSE


The aim of this article is to investigate the acute effects of bench press sets leading to muscular failure with different loads on intraocular pressure and ocular perfusion pressure.
STUDY DESIGN


A randomized experimental study.
METHODS


Seventeen physically active young men performed four resistance training sets of bench press to muscular failure against different relative loads (65% one-repetition maximum vs 75% one-repetition maximum vs 85% one-repetition maximum vs 95% one-repetition maximum). Intraocular pressure was measured before and immediately after the execution of each of the four sets, and ocular perfusion pressure was also assessed before and after physical effort.
RESULTS


We found that intraocular pressure increased after reaching muscular failure (p < 0.001, ƞ²= 0.52), being also dependent on the interaction load × point of measure (p < 0.001, ƞ²= 0.33). Our data demonstrated that higher intraocular pressure increases were found when participants performed the bench press exercise against heavier loads, showing statistical significance for the 75% one-repetition maximum (p = 0.020, d = -0.63, mean change = 0.9 mmHg), 85% one-repetition maximum (p = 0.035, d = -0.56, mean change = 1.4 mmHg), and 95% one-repetition maximum (p < 0.001, d = -1.36, mean change = 2.9 mmHg) relative loads. For its part, ocular perfusion pressure showed a reduction after exercise (p = 0.009, ƞ²= 0.35), being these changes independent on the load used.
CONCLUSION


Bench press exercise leading to muscular failure provokes an acute intraocular pressure rise, with greater changes when heavier loads are used. Ocular perfusion pressure exhibited an acute reduction after exercise; however, its clinical relevance seems to be insignificant (lower to 4%). We argue that the use of heavy loads, when training to muscular failure, should be discouraged in order to avoid acute intraocular pressure fluctuations. Future studies should corroborate the generalizability of these findings in glaucoma patients.",2019,"For its part, ocular perfusion pressure showed a reduction after exercise (p = 0.009, ƞ²= 0.35), being these changes independent on the load used.
","['Seventeen physically active young men', 'glaucoma patients']",[],"['intraocular pressure increases', 'Ocular perfusion pressure', 'ocular perfusion pressure', 'repetition maximum', 'Intraocular pressure', 'intraocular pressure and ocular perfusion pressure', 'intraocular pressure']","[{'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0556453', 'cui_str': 'Physically active (finding)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0234708', 'cui_str': 'Raised intraocular pressure (finding)'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}]",17.0,0.0381713,"For its part, ocular perfusion pressure showed a reduction after exercise (p = 0.009, ƞ²= 0.35), being these changes independent on the load used.
","[{'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Vera', 'Affiliation': 'Department of Optics, Faculty of Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Raimundo', 'Initials': 'R', 'LastName': 'Jiménez', 'Affiliation': 'Department of Optics, Faculty of Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Beatríz', 'Initials': 'B', 'LastName': 'Redondo', 'Affiliation': 'Department of Optics, Faculty of Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Torrejón', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Carlos Gustavo', 'Initials': 'CG', 'LastName': 'de Moraes', 'Affiliation': 'Department of Ophthalmology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Amador', 'Initials': 'A', 'LastName': 'García-Ramos', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}]",European journal of ophthalmology,['10.1177/1120672119879838']
1634,31584682,Effect of Comprehensive Care Coordination on Medicaid Expenditures Compared With Usual Care Among Children and Youth With Chronic Disease: A Randomized Clinical Trial.,"Importance


Medicaid spending on children and young adults with chronic disease could be decreased through care coordination programs by reducing unnecessary hospital and emergency care.
Objective


To assess whether a comprehensive care coordination program reduces Medicaid expenditures by decreasing hospital and emergency department (ED) utilization.
Design, Setting, and Participants


This randomized clinical trial included 6259 children and young adults with chronic disease who received public insurance through Illinois Medicaid. In April 2016, eligible youth were randomized to receive comprehensive care coordination through the Coordinated Healthcare for Complex Kids (CHECK) program (n = 3126) or usual care (n = 3119) to measure the effect of the CHECK program on Medicaid expenditures and health care utilization using a difference-in-differences (DID) approach. Data were collected from May 1, 2014, to April 30, 2017, and analyzed in May 2018.
Interventions


Care coordination, mental health care, education, and social support were provided to CHECK participants and their family members. Services were tailored based on family and participant need.
Main Outcomes and Measures


Mean annual Medicaid expenditures, mean annual health care utilization by category (ED and inpatient), and chronic disease type and risk level.
Results


A total of 6259 participants (mean [SD] age, 11.3 [6.4] years; 2918 [46.6%] female; 2594 [41.4%] with medium and high risk) were randomized. Following the exclusion of 14 outliers, 6245 participants were analyzed. The mean (SD) annual Medicaid expenditure before the intervention was $1633 ($4006) for the intervention group and $1703 ($4466) for the usual care group, which decreased to a mean (SD) of $1341 ($3004) and $1413 ($3785), respectively, after the intervention (DID, -$1; 95% CI, -$199 to $196; P = .99). The mean (SD) inpatient utilization before the intervention was 63.0 (344.4) per 1000 person-years (PYs) for the intervention group and 69.3 (370.9) per 1000 PYs for the usual care group, which decreased to 43.5 (297.2) per 1000 PYs and 47.8 (304.9) per 1000 PYs, respectively, after the intervention (DID, 2.0; 95% CI, -17.9 to 21.8; P = .85). Among participants with asthma, those in the intervention group had a greater mean (SD) decrease in ED utilization compared with usual care, but the difference was not significant (-225.9 [65.3] vs -104.5 [80.0] visits per 1000 PY; DID, -121.5; 95% CI, -268.9 to 26.0; P = .11). Similarly, enrolled participants with sickle cell disease had a smaller but not significant mean (SD) increase in ED utilization compared with usual care (583.3 [839.0] vs 3761.9 [4611.2] visits per 1000 PYs; DID, -3178.6; 95% CI, -10 724.3 to 4367.2; P = .41).
Conclusions and Relevance


Overall Medicaid expenditures and health care utilization (hospital and ED) decreased similarly for both CHECK participants and the usual care group.
Trial Registration


ClinicalTrials.gov identifier: NCT04057521.",2019,"The mean (SD) annual Medicaid expenditure before the intervention was $1633 ($4006) for the intervention group and $1703 ($4466) for the usual care group, which decreased to a mean (SD) of $1341 ($3004) and $1413 ($3785), respectively, after the intervention (DID, -$1; 95% CI, -$199 to $196; P = .99).","['6245 participants were analyzed', 'Children and Youth With Chronic Disease', '6259 children and young adults with chronic disease who received public insurance through Illinois Medicaid', 'enrolled participants with sickle cell disease', 'In April 2016, eligible youth', '6259 participants (mean [SD] age, 11.3 [6.4] years; 2918 [46.6%] female; 2594 [41.4%] with medium and high risk', 'children and young adults with chronic disease']","['comprehensive care coordination through the Coordinated Healthcare for Complex Kids (CHECK) program (n\u2009=\u20093126) or usual care', 'comprehensive care coordination program', 'Usual Care', 'Comprehensive Care Coordination', 'CHECK program']","['ED utilization', 'mean (SD) annual Medicaid expenditure', 'greater mean (SD) decrease in ED utilization', 'Medicaid Expenditures', 'mean (SD) inpatient utilization', 'Mean annual Medicaid expenditures, mean annual health care utilization by category (ED and inpatient), and chronic disease type and risk level']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517822', 'cui_str': '6.4 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0818338,"The mean (SD) annual Medicaid expenditure before the intervention was $1633 ($4006) for the intervention group and $1703 ($4466) for the usual care group, which decreased to a mean (SD) of $1341 ($3004) and $1413 ($3785), respectively, after the intervention (DID, -$1; 95% CI, -$199 to $196; P = .99).","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Caskey', 'Affiliation': 'Department of Medicine, University of Illinois at Chicago.'}, {'ForeName': 'Kellyn', 'Initials': 'K', 'LastName': 'Moran', 'Affiliation': 'College of Pharmacy, University of Illinois at Chicago.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Touchette', 'Affiliation': 'College of Pharmacy, University of Illinois at Chicago.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Department of Pediatrics, University of Illinois at Chicago.'}, {'ForeName': 'Garret', 'Initials': 'G', 'LastName': 'Munoz', 'Affiliation': 'Department of Pediatrics, University of Illinois at Chicago.'}, {'ForeName': 'Pinal', 'Initials': 'P', 'LastName': 'Kanabar', 'Affiliation': 'Research Resource Center, University of Illinois at Chicago.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Van Voorhees', 'Affiliation': 'Department of Pediatrics, University of Illinois at Chicago.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.12604']
1635,28149823,Effect of training problem-solving skill on decision-making and critical thinking of personnel at medical emergencies.,"BACKGROUND


The aim of this study was to determine the effect of problem-solving training on decision-making skill and critical thinking in emergency medical personnel.
MATERIALS AND METHODS


This study is an experimental study that performed in 95 emergency medical personnel in two groups of control (48) and experimental (47). Then, a short problem-solving course based on 8 sessions of 2 h during the term, was performed for the experimental group. Of data gathering was used demographic and researcher made decision-making and California critical thinking skills questionnaires. Data were analyzed using SPSS software.
RESULTS


The finding revealed that decision-making and critical thinking score in emergency medical personnel are low and problem-solving course, positively affected the personnel' decision-making skill and critical thinking after the educational program ( P  < 0.05).
CONCLUSIONS


Therefore, this kind of education on problem-solving in various emergency medicine domains such as education, research, and management, is recommended.",2016,"Therefore, this kind of education on problem-solving in various emergency medicine domains such as education, research, and management, is recommended.","['95 emergency medical personnel in two groups of control (48) and experimental (47', 'personnel at medical emergencies']","['training problem-solving skill', 'problem-solving training']",[],"[{'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0543432', 'cui_str': 'Problem solving training (procedure)'}]",[],95.0,0.0187627,"Therefore, this kind of education on problem-solving in various emergency medicine domains such as education, research, and management, is recommended.","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Heidari', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Shahrekord University of Medical Sciences, Shahrekord, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Shahbazi', 'Affiliation': 'Department of Nursing, Borujen Nursing Faculty, Shahrekord University of Medical Sciences, Shahrekord, Iran.'}]",International journal of critical illness and injury science,['10.4103/2229-5151.195445']
1636,27490418,Wound Healing Complications in Kidney Transplant Recipients Receiving Everolimus.,"BACKGROUND


De novo use of mammalian target of rapamycin inhibitors after kidney transplantation is associated with a concentration-dependent incidence of wound healing adverse events (WHAE). The objective of this analysis was to compare the incidence of WHAE in patients receiving everolimus (EVR) or mycophenolate sodium (MPS).
METHODS


This was a predefined subanalysis of a single-center prospective randomized study in which 288 kidney transplant recipients receiving tacrolimus and prednisone were randomized for 3 different regimens: rabbit antithymocyte globulin (r-ATG)/EVR (N = 85); basiliximab (BAS)/EVR (N = 102); BAS/MPS (N = 101). Clinical WHAE were prospectively collected using a prespecified case report form in all study visits. Abdominal ultrasound was performed at 30 days posttransplant to capture subclinical abnormalities. Surgeons were blinded to randomized treatment and no specific surgical procedures were implemented.
RESULTS


A higher proportion of patients in BAS/EVR showed at least 1 clinical WHAE (22.3% vs 35.3% vs 22.0%, P = 0.03) and total clinical and subclinical WHAE (35% vs 42% vs 26%, P = 0.014) compared with BAS/MPS, respectively. A higher proportion of patients in r-ATG/EVR showed subclinical WHAE (13% vs 7% vs 4%, P = 0.025) compared with BAS/MPS, respectively. Patients receiving EVR showed a higher risk of developing clinical or subclinical WHAE (r-ATG/EVR vs BAS/MPS hazard ratio 1.30; BAS/EVR vs BAS/MPS hazard ratio 1.73, P = 0.028).
CONCLUSIONS


In this cohort of de novo kidney transplant recipients receiving tacrolimus and prednisone, the use of EVR was associated with higher incidence of combined clinical and subclinical WHAE compared with MPS.",2017,"Patients receiving EVR showed a higher risk of developing clinical or subclinical WHAE (r-ATG/EVR vs BAS/MPS hazard ratio 1.30; BAS/EVR vs BAS/MPS hazard ratio 1.73, P = 0.028).
","['patients receiving everolimus (EVR) or', 'Kidney Transplant Recipients Receiving', '288 kidney transplant recipients receiving']","['Everolimus', 'mycophenolate sodium (MPS', 'rabbit antithymocyte globulin (r-ATG)/EVR (N = 85); basiliximab (BAS)/EVR (N = 102); BAS/MPS', 'tacrolimus and prednisone']","['total clinical and subclinical WHAE', 'higher risk of developing clinical or subclinical WHAE', 'subclinical WHAE', 'incidence of WHAE', 'Wound Healing Complications', 'clinical WHAE']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C1337395', 'cui_str': 'mycophenolate sodium'}, {'cui': 'C0359156', 'cui_str': 'Rabbit anti-human T-lymphocyte globulin'}, {'cui': 'C0676831', 'cui_str': 'basiliximab'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205211', 'cui_str': 'Subclinical (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",288.0,0.0924539,"Patients receiving EVR showed a higher risk of developing clinical or subclinical WHAE (r-ATG/EVR vs BAS/MPS hazard ratio 1.30; BAS/EVR vs BAS/MPS hazard ratio 1.73, P = 0.028).
","[{'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Ueno', 'Affiliation': '1 Nephrology Division, Hospital do Rim, Universidade Federal de Sao Paulo, São Paulo, SP, Brazil. 2 Urology Division, Hospital do Rim, Universidade Federal de Sao Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Felipe', 'Affiliation': ''}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Ferreira', 'Affiliation': ''}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Cristelli', 'Affiliation': ''}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'Viana', 'Affiliation': ''}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Mansur', 'Affiliation': ''}, {'ForeName': 'Geovana', 'Initials': 'G', 'LastName': 'Basso', 'Affiliation': ''}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Hannun', 'Affiliation': ''}, {'ForeName': 'Wilson', 'Initials': 'W', 'LastName': 'Aguiar', 'Affiliation': ''}, {'ForeName': 'Helio', 'Initials': 'H', 'LastName': 'Tedesco Silva', 'Affiliation': ''}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Medina-Pestana', 'Affiliation': ''}]",Transplantation,['10.1097/TP.0000000000001392']
1637,32492153,VITamin D and OmegA-3 TriaL (VITAL): Effects of Vitamin D Supplements on Risk of Falls in the US Population.,"CONTEXT


It is unclear whether vitamin D supplementation reduces risk of falls, and results from randomized controlled trials (RCTs) are conflicting.
OBJECTIVE


To determine whether 2000 IU/day of supplemental vitamin D3 decreases fall risk.
DESIGN


VITamin D and OmegA-3 TriaL (VITAL) is a double-blind, placebo-controlled RCT including 25,871 adults, randomized November 2011-March 2014 and treated for 5.3 years (median).
SETTING


Nationwide study.
PARTICIPANTS


Men ≥50 and women ≥55 years (mean age 67.1 years) without cancer or cardiovascular disease at baseline.
INTERVENTIONS


Vitamin D3 (cholecalciferol; 2,000 IU/day) and/or omega-3 fatty acids (1 g/day) or respective placebos in a 2X2 factorial design.
MAIN OUTCOME MEASURES


Two or more falls, falls resulting in a doctor or hospital visit.
RESULTS


Baseline serum total 25-hydroxyvitamin D [25(OH)D] level was 77 nmol/L; characteristics were well-balanced between groups. Numbers of participants with ≥2 falls were similar between active and placebo groups (9.8% vs. 9.4%). Over 5 years, there were no differences in the proportion having ≥2 falls (OR=0.97; 95% CI, 0.90-1.05, p=0.50), falls resulting in a doctor visit (OR=1.03; 95% CI, 0.94-1.13, p=0.46) or resulting in a hospital visit (OR=1.04; 95% CI, 0.90-1.19, p=0.61) between groups. Results did not differ between those with baseline 25(OH)D <50 vs. >50 nmol/L or other cutpoints.
CONCLUSION


Daily supplemental vitamin D3 vs. placebo did not decrease fall risk in generally healthy adults not selected for vitamin D insufficiency. This large RCT does not indicate that supplemental vitamin D should be used for primary prevention of falls in the U.S. population.",2020,Results did not differ between those with baseline 25(OH)D,"['Men ≥50 and women ≥55 years (mean age 67.1 years) without cancer or cardiovascular disease at baseline', 'Nationwide study', '25,871 adults, randomized November 2011-March 2014 and treated for 5.3 years (median', 'generally healthy adults']","['vitamin D3 vs. placebo', 'supplemental vitamin D3', 'VITamin D and OmegA-3 TriaL (VITAL', 'placebo-controlled RCT', 'VITamin D and OmegA-3 TriaL', 'Vitamin D3 (cholecalciferol; 2,000 IU/day', 'Vitamin D Supplements', 'and/or omega-3 fatty acids (1 g/day) or respective placebos', 'vitamin D supplementation', 'placebo']","['proportion having ≥2 falls', 'falls resulting in a doctor visit', 'Risk of Falls', 'Baseline serum total 25-hydroxyvitamin D [25(OH)D] level', 'fall risk', 'falls, falls resulting in a doctor or hospital visit']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",25871.0,0.702356,Results did not differ between those with baseline 25(OH)D,"[{'ForeName': 'Meryl S', 'Initials': 'MS', 'LastName': 'LeBoff', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital Boston, MA, United States.""}, {'ForeName': 'Elle M', 'Initials': 'EM', 'LastName': 'Murata', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital Boston, MA, United States.""}, {'ForeName': 'Nancy R', 'Initials': 'NR', 'LastName': 'Cook', 'Affiliation': 'Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Cawthon', 'Affiliation': 'California Pacific Medical Center, Research Institute, University of California, San Francisco, CA, United States.'}, {'ForeName': 'Sharon H', 'Initials': 'SH', 'LastName': 'Chou', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital Boston, MA, United States.""}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Kotler', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States.""}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Bubes', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States.""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': 'Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': 'Harvard Medical School, Boston, MA, United States.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa311']
1638,32414137,Alcohol Hangover Does Not Alter the Application of Model-Based and Model-Free Learning Strategies.,"Frequent alcohol binges shift behavior from goal-directed to habitual processing modes. This shift in reward-associated learning strategies plays a key role in the development and maintenance of alcohol use disorders and seems to persist during (early stages of) sobriety in at-risk drinkers. Yet still, it has remained unclear whether this phenomenon might be associated with alcohol hangover and thus also be found in social drinkers. In an experimental crossover design,  n  = 25 healthy young male participants performed a two-step decision-making task once sober and once hungover (i.e., when reaching sobriety after consuming 2.6 g of alcohol per estimated liter of total body water). This task allows the separation of effortful model-based and computationally less demanding model-free learning strategies. The experimental induction of alcohol hangover was successful, but we found no significant hangover effects on model-based and model-free learning scores, the balance between model-free and model-based valuation (ω), or perseveration tendencies (π). Bayesian analyses provided positive evidence for the null hypothesis for all measures except π (anecdotal evidence for the null hypothesis). Taken together, alcohol hangover, which results from a single binge drinking episode, does not impair the application of effortful and computationally costly model-based learning strategies and/or increase model-free learning strategies. This supports the notion that the behavioral deficits observed in at-risk drinkers are most likely not caused by the immediate aftereffects of individual binge drinking events.",2020,Bayesian analyses provided positive evidence for the null hypothesis for all measures except π (anecdotal evidence for the null hypothesis).,['n  = 25 healthy young male participants'],[],[],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}]",[],[],25.0,0.00984522,Bayesian analyses provided positive evidence for the null hypothesis for all measures except π (anecdotal evidence for the null hypothesis).,"[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Berghäuser', 'Affiliation': 'Chair of Addiction Research, Institute for Clinical Psychology and Psychotherapy, Faculty of Psychology TU Dresden, Chemnitzer Str. 46, 01062 Dresden, Germany.'}, {'ForeName': 'Wiebke', 'Initials': 'W', 'LastName': 'Bensmann', 'Affiliation': 'Cognitive Neurophysiology, Department of Child and Adolescent Psychiatry, Faculty of Medicine, TU Dresden, Fetscherstr. 74, 01307 Dresden, Germany.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Zink', 'Affiliation': 'Cognitive Neurophysiology, Department of Child and Adolescent Psychiatry, Faculty of Medicine, TU Dresden, Fetscherstr. 74, 01307 Dresden, Germany.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Endrass', 'Affiliation': 'Chair of Addiction Research, Institute for Clinical Psychology and Psychotherapy, Faculty of Psychology TU Dresden, Chemnitzer Str. 46, 01062 Dresden, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Beste', 'Affiliation': 'Cognitive Neurophysiology, Department of Child and Adolescent Psychiatry, Faculty of Medicine, TU Dresden, Fetscherstr. 74, 01307 Dresden, Germany.'}, {'ForeName': 'Ann-Kathrin', 'Initials': 'AK', 'LastName': 'Stock', 'Affiliation': 'Cognitive Neurophysiology, Department of Child and Adolescent Psychiatry, Faculty of Medicine, TU Dresden, Fetscherstr. 74, 01307 Dresden, Germany.'}]",Journal of clinical medicine,['10.3390/jcm9051453']
1639,31610936,Predictors and Outcomes of Early Intubation in Infants Born at 28-36 Weeks of Gestation Receiving Noninvasive Respiratory Support.,"OBJECTIVE


To identify predictors and outcomes of early intubation in preterm infants with respiratory distress, and predictors of need for brief respiratory support (≤1 day).
STUDY DESIGN


Secondary analysis of data from a randomized trial comparing nasal high-flow with continuous positive airway pressure as primary respiratory support in preterm infants born at 28-36 weeks of gestation. Intubation was assessed within 72 hours of randomization.
RESULTS


There were 564 included infants with a mean (SD) gestational age of 32.0 (2.2) weeks and birth weight 1744 (589) g; 76 infants (13.5%) received early intubation. On multivariable analysis, lower gestational age and higher pre-randomization fraction of inspired oxygen (FiO 2 ) predicted intubation. A test based on gestational age of <30 weeks and an FiO 2  of ≥0.30 produced a likelihood ratio of 9.1. Intubation was associated with prolonged duration of respiratory support and supplemental oxygen, with pneumothorax and nasal trauma, and in infants born at <32 weeks of gestational, with bronchopulmonary dysplasia and patent ductus arteriosus requiring treatment. Greater gestational age and lower FiO 2  predicted the need for ≤1 day of respiratory support. A test based on a gestational age of ≥34 weeks and an FiO 2  of 0.21 produced a likelihood ratio of 4.7.
CONCLUSIONS


In preterm infants 28-36 week of gestation receiving primary noninvasive respiratory support, lower gestational age, and higher FiO 2  predicted need for intubation within 72 hours. Intubation was associated with adverse respiratory outcomes. Greater gestational age and lower FiO 2  predicted need for ≤1 day of respiratory support. It may be reasonable to defer the use of respiratory support in more mature infants with low FiO 2  requirements. TRIAL REGISTRATION AUSTRALIAN NEW ZEALAND CLINICAL TRIALS REGISTRY: ACTRN12613000303741.",2020,"Intubation was associated with prolonged duration of respiratory support and supplemental oxygen, with pneumothorax and nasal trauma, and in infants born at <32 weeks of gestational, with bronchopulmonary dysplasia and patent ductus arteriosus requiring treatment.","['infants born at <32\xa0weeks of gestational, with bronchopulmonary dysplasia and patent ductus arteriosus requiring treatment', 'Infants Born at 28-36\xa0Weeks of Gestation Receiving Noninvasive Respiratory Support', '564 included infants with a mean (SD) gestational age of 32.0 (2.2) weeks and birth weight 1744 (589) g; 76 infants (13.5%) received early intubation', 'preterm infants born at 28-36\xa0weeks of gestation', 'preterm infants with respiratory distress, and predictors of need for brief respiratory support (≤1\xa0day', 'preterm infants 28-36\xa0week of gestation receiving primary noninvasive respiratory support, lower gestational age, and higher FiO 2  predicted need for intubation within 72\xa0hours']",['nasal high-flow with continuous positive airway pressure'],[],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary Dysplasia'}, {'cui': 'C3495549', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C4517559', 'cui_str': '13.5 (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress (finding)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1292423', 'cui_str': '72 hours (qualifier value)'}]","[{'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}]",[],,0.211618,"Intubation was associated with prolonged duration of respiratory support and supplemental oxygen, with pneumothorax and nasal trauma, and in infants born at <32 weeks of gestational, with bronchopulmonary dysplasia and patent ductus arteriosus requiring treatment.","[{'ForeName': 'Calum T', 'Initials': 'CT', 'LastName': 'Roberts', 'Affiliation': ""Monash Newborn, Monash Children's Hospital, Melbourne, Victoria, Australia; Department of Pediatrics, Monash University, Melbourne, Victoria, Australia; Newborn Research Centre, The Royal Women's Hospital, Melbourne, Victoria, Australia. Electronic address: calum.roberts@monash.edu.""}, {'ForeName': 'Louise S', 'Initials': 'LS', 'LastName': 'Owen', 'Affiliation': ""Newborn Research Centre, The Royal Women's Hospital, Melbourne, Victoria, Australia; Department of Obstetrics and Gynecology, The University of Melbourne, Melbourne, Victoria, Australia; Clinical Sciences, Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Dag H', 'Initials': 'DH', 'LastName': 'Frøisland', 'Affiliation': ""Newborn Research Centre, The Royal Women's Hospital, Melbourne, Victoria, Australia; Department of Pediatrics, Innlandet Hospital Trust, Lillehammer, Norway.""}, {'ForeName': 'Lex W', 'Initials': 'LW', 'LastName': 'Doyle', 'Affiliation': ""Newborn Research Centre, The Royal Women's Hospital, Melbourne, Victoria, Australia; Department of Obstetrics and Gynecology, The University of Melbourne, Melbourne, Victoria, Australia; Clinical Sciences, Murdoch Children's Research Institute, Melbourne, Victoria, Australia; Department of Pediatrics, The University of Melbourne, Melbourne, Australia.""}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Davis', 'Affiliation': ""Newborn Research Centre, The Royal Women's Hospital, Melbourne, Victoria, Australia; Department of Obstetrics and Gynecology, The University of Melbourne, Melbourne, Victoria, Australia; Clinical Sciences, Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Brett J', 'Initials': 'BJ', 'LastName': 'Manley', 'Affiliation': ""Newborn Research Centre, The Royal Women's Hospital, Melbourne, Victoria, Australia; Department of Obstetrics and Gynecology, The University of Melbourne, Melbourne, Victoria, Australia; Clinical Sciences, Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.09.026']
1640,27694157,A Randomized Phase II Study of Linsitinib (OSI-906) Versus Topotecan in Patients With Relapsed Small-Cell Lung Cancer.,"LESSONS LEARNED


Targeted therapy options for SCLC patients are limited; no agent, thus far, has resulted in a strategy promising enough to progress to phase III trials.Linsitinib, a potent insulin growth factor-1-receptor tyrosine kinase inhibitor, may be one agent with activity against SCLC.Despite lack of a reliable predictive biomarker in this disease, which may have partly contributed to the negative outcome reported here, linsitinib, although safe, showed no clinical activity in unselected, relapsed SCLC patients.
BACKGROUND


Treatment of relapsed small-cell lung cancer (SCLC) remains suboptimal. Insulin growth factor-1 receptor (IGF-1R) signaling plays a role in growth, survival, and chemoresistance in SCLC. Linsitinib is a potent IGF-1R tyrosine kinase inhibitor that potentially may be active against SCLC.
METHODS


In this phase II study, 8 eligible patients were randomly assigned in a 1:2 ratio to topotecan (1.5 mg/m 2  intravenously or 2.3 mg/m 2  orally, daily for 5 days for 4 cycles) or linsitinib (150 mg orally twice daily until progression). The primary endpoint was progression-free survival. Patients with relapsed SCLC, platinum sensitive or resistant, performance status (PS) 0-2, and adequate hematologic, renal, and hepatic function were enrolled. Patients with diabetes, cirrhosis, and those taking insulinotropic agents were excluded. Crossover to linsitinib was allowed at progression.
RESULTS


Fifteen patients received topotecan (8 resistant, 3 with PS 2) and 29 received linsitinib (16 resistant, 5 with PS 2). Two partial responses were observed with topotecan. Only 4 of 15 patients with topotecan and 1 of 29 with linsitinib achieved stable disease. Median progression-free survival was 3.0 (95% confidence interval [CI], 1.5-3.6) and 1.2 (95% CI, 1.1-1.4) months for topotecan and linsitinib, respectively (p = .0001). Median survival was 5.3 (95% CI, 2.2-7.6) and 3.4 (95% CI, 1.8-5.6) months for topotecan and linsitinib, respectively (p = .71). Grade 3/4 adverse events (>5% incidence) included anemia, thrombocytopenia, neutropenia/leukopenia, diarrhea, fatigue, dehydration, and hypokalemia for topotecan; and thrombocytopenia, fatigue, and alanine aminotransferase/aspartate aminotransferase elevations for linsitinib.
CONCLUSION


Linsitinib was safe but showed no clinical activity in unselected, relapsed SCLC patients.",2016,"Median progression-free survival was 3.0 (95% confidence interval [CI], 1.5-3.6) and 1.2 (95% CI, 1.1-1.4) months for topotecan and linsitinib, respectively (p = .0001).","['Patients with relapsed SCLC, platinum sensitive or resistant, performance status (PS) 0-2, and adequate hematologic, renal, and hepatic function were enrolled', 'Patients With Relapsed Small-Cell Lung Cancer', 'Patients with diabetes, cirrhosis, and those taking insulinotropic agents were excluded', 'relapsed small-cell lung cancer (SCLC', '8 eligible patients', '15 patients with topotecan and 1 of 29 with linsitinib achieved stable disease']","['Linsitinib (OSI-906', 'topotecan', 'Topotecan', 'linsitinib']","['Grade 3/4 adverse events', 'anemia, thrombocytopenia, neutropenia/leukopenia, diarrhea, fatigue, dehydration, and hypokalemia for topotecan; and thrombocytopenia, fatigue, and alanine aminotransferase/aspartate aminotransferase elevations for linsitinib', 'Median survival', 'progression-free survival', 'Median progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0149925', 'cui_str': 'Oat Cell Lung Cancer'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0146224', 'cui_str': 'Topotecan'}, {'cui': 'C2987649'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C2987649'}, {'cui': 'C2346449', 'cui_str': 'OSI 906'}, {'cui': 'C0146224', 'cui_str': 'Topotecan'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0020621', 'cui_str': 'Hypopotassemia'}, {'cui': 'C0146224', 'cui_str': 'Topotecan'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C2987649'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",8.0,0.0471026,"Median progression-free survival was 3.0 (95% confidence interval [CI], 1.5-3.6) and 1.2 (95% CI, 1.1-1.4) months for topotecan and linsitinib, respectively (p = .0001).","[{'ForeName': 'Alberto A', 'Initials': 'AA', 'LastName': 'Chiappori', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA alberto.chiappori@moffitt.org.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Otterson', 'Affiliation': 'Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Dowlati', 'Affiliation': 'University Hospitals Case Medical Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Traynor', 'Affiliation': 'University of Wisconsin, Madison, Wisconsin, USA.'}, {'ForeName': 'Leora', 'Initials': 'L', 'LastName': 'Horn', 'Affiliation': 'Vanderbilt University, Nashville, Tennessee, USA.'}, {'ForeName': 'Taofeek K', 'Initials': 'TK', 'LastName': 'Owonikoko', 'Affiliation': 'Winship Cancer Institute of Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Helen J', 'Initials': 'HJ', 'LastName': 'Ross', 'Affiliation': 'Mayo Clinic, Scottsdale, Arizona, USA.'}, {'ForeName': 'Christine L', 'Initials': 'CL', 'LastName': 'Hann', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Taher', 'Initials': 'T', 'LastName': 'Abu Hejleh', 'Affiliation': 'University of Iowa Hospitals and Clinics, Iowa City, Iowa, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Nieva', 'Affiliation': 'University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Xiuhua', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schell', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Sullivan', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA.'}]",The oncologist,[]
1641,32414888,Deep neuromuscular block improves angiographic image quality during endovascular coiling of unruptured cerebral aneurysm: a randomized clinical trial.,"BACKGROUND


Neuromuscular block (NMB) used during general anesthesia induces transient skeletal muscle paralysis, but patient movements during endovascular coiling still occur to some degree. Compared with moderate NMB, deep NMB may further improve the intervention condition during endovascular coiling for unruptured cerebral aneurysms; however, little research has focused on the angiographic image quality.
METHODS


This prospective, randomized, double-blind clinical trial included 58 patients treated for unruptured cerebral aneurysms with endovascular coiling under general anesthesia. Patients were randomly allocated to either the deep NMB group (post-tetanic count 1 or 2) or the moderate NMB group (train-of-four 1 or 2). The primary outcome was the proportion of patients with a satisfactory intervention condition assessed by surgeons after the procedure using a 5-point intervention condition rating scale (ICRS) from 1 (unable to obtain image) to 5 (optimal); ICRS 5 was defined as satisfactory.
RESULTS


There were significantly more cases of satisfactory intervention condition in the deep NMB group than in the moderate NMB group (82.1% vs 51.7%, p=0.015). The frequency of each ICRS score was significantly different between the groups (ICRS 5/4/3/2/1: 23/5/0/0/0 vs 15/9/2/3/0, p=0.035). The incidence of major patient movement requiring rescue muscle relaxant was 10.3% in the moderate NMB group and 0% in the deep NMB group (p=0.237). The drugs used to maintain hemodynamic stability were not significantly different between the two groups.
CONCLUSIONS


Deep NMB improves the intervention condition during endovascular coiling by improving the image quality.",2020,"The frequency of each ICRS score was significantly different between the groups (ICRS 5/4/3/2/1: 23/5/0/0/0 vs 15/9/2/3/0, p=0.035).","['58 patients treated for unruptured cerebral aneurysms with endovascular coiling under general anesthesia', 'endovascular coiling of unruptured cerebral aneurysm']","['Deep neuromuscular block', 'Deep NMB', 'Neuromuscular block (NMB', 'deep NMB group (post-tetanic count 1 or 2) or the moderate NMB']","['hemodynamic stability', 'angiographic image quality', 'proportion of patients with a satisfactory intervention condition assessed by surgeons after the procedure using a 5-point intervention condition rating scale (ICRS', 'frequency of each ICRS score', 'satisfactory intervention condition', 'incidence of major patient movement requiring rescue muscle relaxant']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0155730', 'cui_str': 'Cerebral aneurysm, nonruptured'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0235062', 'cui_str': 'Induction of neuromuscular blockade'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0428701', 'cui_str': 'Post-tetanic count'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0026827', 'cui_str': 'Decreased muscle tone'}]",58.0,0.137455,"The frequency of each ICRS score was significantly different between the groups (ICRS 5/4/3/2/1: 23/5/0/0/0 vs 15/9/2/3/0, p=0.035).","[{'ForeName': 'Bo Young', 'Initials': 'BY', 'LastName': 'Kim', 'Affiliation': 'Graduate School, Department of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Sung Hoon', 'Initials': 'SH', 'LastName': 'Chung', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Seong-Joo', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Sung-Hee', 'Initials': 'SH', 'LastName': 'Han', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'O-Ki', 'Initials': 'OK', 'LastName': 'Kwon', 'Affiliation': 'Department of Neurosurgery, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Jun-Young', 'Initials': 'JY', 'LastName': 'Chung', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, College of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Jin-Hee', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea anesing1@snu.ac.kr.'}]",Journal of neurointerventional surgery,['10.1136/neurintsurg-2020-015947']
1642,32492157,Young adult outcomes of childhood prophylaxis for severe hemophilia A: results of the Joint Outcome Continuation Study.,"The Joint Outcome Study (JOS), a randomized controlled trial, demonstrated that children with severe hemophilia A (HA) initiating prophylactic factor VIII (FVIII) prior to age 2.5 years had reduced joint damage at age 6 years compared with those treated with episodic FVIII for bleeding. The Joint Outcome Continuation Study (JOS-C) evaluated early vs delayed prophylaxis effects on long-term joint health, following JOS participants to age 18 years in an observational, partially retrospective study. Index joint magnetic resonance imaging (MRI) scores of osteochondral (OC) damage (primary outcome), joint physical examination scores, and annualized rates of joint/other bleeding episodes (secondary outcomes) were collected. Thirty-seven of 65 JOS participants enrolled in JOS-C, including 15 randomized to prophylaxis at mean age 1.3 years (""early prophylaxis""); 18 initially randomized to episodic treatment, starting ""delayed prophylaxis"" at mean age 7.5 years; and 4 with high-titer inhibitors. At JOS-C exit, MRI OC damage was found in 77% of those on delayed and 35% of those on early prophylaxis for an odds ratio of OC damage, in the delayed vs early prophylaxis group, of 6.3 (95% confidence interval, 1.3, 29.9; P = .02). Annualized bleeding rates were higher with delayed prophylaxis (mean plus or minus standard deviation, 10.6 ± 6.6 vs 3.5 ± 2.1; P < .001), including when only comparing time periods on prophylaxis (6.2 ± 5.3 vs 3.3 ± 1.9; P < .05). In severe HA, early initiation of prophylaxis provided continued protection against joint damage throughout childhood compared with delayed initiation, but early prophylaxis was not sufficient to fully prevent damage. This trial was registered at www.clinicaltrials.gov as #NCT01000844.",2020,"At JOS-C exit, MRI OC damage was found in 77% of those on delayed and 35% of those on early prophylaxis for an odds ratio of OC damage, in the delayed vs early prophylaxis group, of 6.3 (95% confidence interval, 1.3, 29.9; P = .02).","['JOS participants to age 18 years in an observational, partially retrospective study', 'severe hemophilia A', 'Thirty-seven of 65 JOS participants enrolled in JOS-C, including 15 randomized to prophylaxis at mean age 1.3 years (""early prophylaxis""); 18 initially randomized to episodic treatment, starting ""delayed prophylaxis"" at mean age 7.5 years; and 4 with high-titer inhibitors', 'children with severe hemophilia A (HA) initiating prophylactic factor VIII (FVIII) prior to age 2.5 years had reduced joint damage at age 6 years compared with those treated with episodic FVIII for bleeding']",['childhood prophylaxis'],"['Index joint magnetic resonance imaging (MRI) scores of osteochondral (OC) damage (primary outcome), joint physical examination scores, and annualized rates of joint/other bleeding episodes (secondary outcomes', 'MRI OC damage', 'Annualized bleeding rates']","[{'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C0272322', 'cui_str': 'Severe hereditary factor VIII deficiency disease'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0444497', 'cui_str': 'In joint'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0015506', 'cui_str': 'Factor VIII'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]","[{'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0476169', 'cui_str': 'Osteochondral fracture'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]",18.0,0.141139,"At JOS-C exit, MRI OC damage was found in 77% of those on delayed and 35% of those on early prophylaxis for an odds ratio of OC damage, in the delayed vs early prophylaxis group, of 6.3 (95% confidence interval, 1.3, 29.9; P = .02).","[{'ForeName': 'Beth Boulden', 'Initials': 'BB', 'LastName': 'Warren', 'Affiliation': 'Hemophilia and Thrombosis Center, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Dianne', 'Initials': 'D', 'LastName': 'Thornhill', 'Affiliation': 'Hemophilia and Thrombosis Center, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Stein', 'Affiliation': ""Section of Pediatric Radiology, Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fadell', 'Affiliation': ""Section of Pediatric Radiology, Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'J David', 'Initials': 'JD', 'LastName': 'Ingram', 'Affiliation': ""Section of Pediatric Radiology, Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Funk', 'Affiliation': 'Hemophilia and Thrombosis Center, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Kristi L', 'Initials': 'KL', 'LastName': 'Norton', 'Affiliation': 'Hemophilia and Thrombosis Center, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Heidi D', 'Initials': 'HD', 'LastName': 'Lane', 'Affiliation': ""Primary Children's Hospital, Salt Lake City, UT.""}, {'ForeName': 'Carolyn M', 'Initials': 'CM', 'LastName': 'Bennett', 'Affiliation': 'Department of Pediatrics, School of Medicine, Emory University, Atlanta, GA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Dunn', 'Affiliation': 'Department of Pediatrics, School of Medicine, Emory University, Atlanta, GA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Recht', 'Affiliation': 'Division of Hematology and Oncology, Department of Pediatrics, Oregon Health & Science University, Portland, OR; and.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Shapiro', 'Affiliation': 'Indiana Hemophilia and Thrombosis Center, Indianapolis, IN.'}, {'ForeName': 'Marilyn J', 'Initials': 'MJ', 'LastName': 'Manco-Johnson', 'Affiliation': 'Hemophilia and Thrombosis Center, University of Colorado Anschutz Medical Campus, Aurora, CO.'}]",Blood advances,['10.1182/bloodadvances.2019001311']
1643,31563344,"Ceftolozane-tazobactam versus meropenem for treatment of nosocomial pneumonia (ASPECT-NP): a randomised, controlled, double-blind, phase 3, non-inferiority trial.","BACKGROUND


Nosocomial pneumonia due to antimicrobial-resistant pathogens is associated with high mortality. We assessed the efficacy and safety of the combination antibacterial drug ceftolozane-tazobactam versus meropenem for treatment of Gram-negative nosocomial pneumonia.
METHODS


We conducted a randomised, controlled, double-blind, non-inferiority trial at 263 hospitals in 34 countries. Eligible patients were aged 18 years or older, were undergoing mechanical ventilation, and had nosocomial pneumonia (either ventilator-associated pneumonia or ventilated hospital-acquired pneumonia). Patients were randomly assigned (1:1) with block randomisation (block size four), stratified by type of nosocomial pneumonia and age (<65 years vs ≥65 years), to receive either 3 g ceftolozane-tazobactam or 1 g meropenem intravenously every 8 h for 8-14 days. The primary endpoint was 28-day all-cause mortality (at a 10% non-inferiority margin). The key secondary endpoint was clinical response at the test-of-cure visit (7-14 days after the end of therapy; 12·5% non-inferiority margin). Both endpoints were assessed in the intention-to-treat population. Investigators, study staff, patients, and patients' representatives were masked to treatment assignment. Safety was assessed in all randomly assigned patients who received study treatment. This trial was registered with ClinicalTrials.gov, NCT02070757.
FINDINGS


Between Jan 16, 2015, and April 27, 2018, 726 patients were enrolled and randomly assigned, 362 to the ceftolozane-tazobactam group and 364 to the meropenem group. Overall, 519 (71%) patients had ventilator-associated pneumonia, 239 (33%) had Acute Physiology and Chronic Health Evaluation II scores of at least 20, and 668 (92%) were in the intensive care unit. At 28 days, 87 (24·0%) patients in the ceftolozane-tazobactam group and 92 (25·3%) in the meropenem group had died (weighted treatment difference 1·1% [95% CI -5·1 to 7·4]). At the test-of-cure visit 197 (54%) patients in the ceftolozane-tazobactam group and 194 (53%) in the meropenem group were clinically cured (weighted treatment difference 1·1% [95% CI -6·2 to 8·3]). Ceftolozane-tazobactam was thus non-inferior to meropenem in terms of both 28-day all-cause mortality and clinical cure at test of cure. Treatment-related adverse events occurred in 38 (11%) of 361 patients in the ceftolozane-tazobactam group and 27 (8%) of 359 in the meropenem group. Eight (2%) patients in the ceftolozane-tazobactam group and two (1%) in the meropenem group had serious treatment-related adverse events. There were no treatment-related deaths.
INTERPRETATION


High-dose ceftolozane-tazobactam is an efficacious and well tolerated treatment for Gram-negative nosocomial pneumonia in mechanically ventilated patients, a high-risk, critically ill population.
FUNDING


Merck & Co.",2019,Treatment-related adverse events occurred in 38 (11%) of 361 patients in the ceftolozane-tazobactam group and 27 (8%) of 359 in the meropenem group.,"['group and 364 to the meropenem group', 'Eligible patients were aged 18 years or older, were undergoing mechanical ventilation, and had nosocomial pneumonia (either ventilator-associated pneumonia or ventilated hospital-acquired pneumonia', '726 patients were enrolled and randomly assigned, 362 to the', 'Between Jan 16, 2015, and April 27, 2018', 'mechanically ventilated patients', '263 hospitals in 34 countries', 'Patients were randomly assigned (1:1) with block randomisation (block size four), stratified by type of nosocomial pneumonia and age (<65 years vs ≥65 years']","['combination antibacterial drug ceftolozane-tazobactam versus meropenem', 'Ceftolozane-tazobactam', 'ceftolozane-tazobactam or 1 g meropenem', 'Ceftolozane-tazobactam versus meropenem', 'ceftolozane-tazobactam', 'meropenem']","['Acute Physiology and Chronic Health Evaluation II scores', 'adverse events', 'Safety', 'efficacy and safety', '28-day all-cause mortality', 'clinical response at the test-of-cure visit', 'serious treatment-related adverse events']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0066005', 'cui_str': 'meropenem'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C1443237', 'cui_str': 'Nosocomial Pneumonia'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0949083', 'cui_str': 'Hospital acquired pneumonia'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C0279516', 'cui_str': 'Anti-Bacterial Agents'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C3656593', 'cui_str': 'ceftolozane / tazobactam'}, {'cui': 'C0066005', 'cui_str': 'meropenem'}]","[{'cui': 'C0243028', 'cui_str': 'APACHE II'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",726.0,0.618555,Treatment-related adverse events occurred in 38 (11%) of 361 patients in the ceftolozane-tazobactam group and 27 (8%) of 359 in the meropenem group.,"[{'ForeName': 'Marin H', 'Initials': 'MH', 'LastName': 'Kollef', 'Affiliation': 'Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Nováček', 'Affiliation': 'General Hospital of Kolin, Kolin, Czech Republic.'}, {'ForeName': 'Ülo', 'Initials': 'Ü', 'LastName': 'Kivistik', 'Affiliation': 'North Estonia Medical Centre, Tallinn, Estonia.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Réa-Neto', 'Affiliation': 'Universidade Federal do Paraná, Curitiba, Brazil.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Shime', 'Affiliation': 'Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Martin-Loeches', 'Affiliation': ""St James's Hospital, Dublin, Ireland; Universitat de Barcelona, Instituto de Investigaciones Biomédicas August Pi i Sunyer, Centro de Investigación Biomédica en Red Enfermedades Respiratorias, Barcelona, Spain.""}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Timsit', 'Affiliation': 'Université Paris Diderot, Paris, France.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Wunderink', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Bruno', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Huntington', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Lin', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Joan R', 'Initials': 'JR', 'LastName': 'Butterton', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Elizabeth G', 'Initials': 'EG', 'LastName': 'Rhee', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA. Electronic address: elizabeth.rhee@merck.com.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30403-7']
1644,27943220,Population Pharmacokinetics and Exploratory Pharmacodynamics of Lorazepam in Pediatric Status Epilepticus.,"BACKGROUND


Lorazepam is one of the preferred agents used for intravenous treatment of status epilepticus (SE). We combined data from two pediatric clinical trials to characterize the population pharmacokinetics of intravenous lorazepam in infants and children aged 3 months to 17 years with active SE or a history of SE.
METHODS


We developed a population pharmacokinetic model for lorazepam using the NONMEM software. We then assessed exploratory exposure-response relationships using the overall efficacy and safety study endpoints, and performed dosing simulations.
RESULTS


A total of 145 patients contributed 439 pharmacokinetic samples. The median (range) age and dose were 5.4 years (0.3-17.8) and 0.10 mg/kg (0.02-0.18), respectively. A two-compartment pharmacokinetic model with allometric scaling described the data well. In addition to total body weight (WT), younger age was associated with slightly higher weight-normalized clearance (CL). The following relationships characterized the typical values for the central compartment volume (V1), CL, peripheral compartment volume (V2), and intercompartmental CL (Q), using individual subject WT (kg) and age (years): V1 (L) = 0.879*WT; CL (L/h) = 0.115*(Age/4.7) 0.133 *WT 0.75 ; V2 (L) = 0.542*V1; Q (L/h) = 1.45*WT 0.75 . No pharmacokinetic parameters were associated with clinical outcomes. Simulations suggest uniform pediatric dosing (0.1 mg/kg, to a maximum of 4 mg) can be used to achieve concentrations of 50-100 ng/mL in children with SE, which have been previously associated with effective seizure control.
CONCLUSIONS


The population pharmacokinetics of lorazepam were successfully described using a sparse sampling approach and a two-compartment model in pediatric patients with active SE.",2017,No pharmacokinetic parameters were associated with clinical outcomes.,"['pediatric patients with active SE', 'infants and children aged 3\xa0months to 17\xa0years with active SE or a history of SE', 'Pediatric Status Epilepticus', '145 patients contributed 439 pharmacokinetic samples']","['Lorazepam', 'lorazepam']","['weight-normalized clearance (CL', 'central compartment volume (V1), CL, peripheral compartment volume (V2), and intercompartmental CL (Q']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0038220', 'cui_str': 'Status Epilepticus, Generalized'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0024002', 'cui_str': 'Lorazepam'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}]",,0.118065,No pharmacokinetic parameters were associated with clinical outcomes.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gonzalez', 'Affiliation': 'Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Chamberlain', 'Affiliation': ""Division of Emergency Medicine, Children's National Medical Center, Washington, DC, USA.""}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Guptill', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cohen-Wolkowiez', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Barrie', 'Initials': 'B', 'LastName': 'Harper', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Emmes Corporation, Rockville, MD, USA.'}, {'ForeName': 'Edmund V', 'Initials': 'EV', 'LastName': 'Capparelli', 'Affiliation': 'Department of Pediatrics and Skaggs School of Pharmacy, University of California, San Diego, 9500 Gilman Drive, La Jolla, CA, 92093-0831, USA. ecapparelli@ucsd.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical pharmacokinetics,['10.1007/s40262-016-0486-0']
1645,32414066,Benefits of Adhering to a Mediterranean Diet Supplemented with Extra Virgin Olive Oil and Pistachios in Pregnancy on the Health of Offspring at 2 Years of Age. Results of the San Carlos Gestational Diabetes Mellitus Prevention Study.,"The intrauterine environment may be related to the future development of chronic diseases in the offspring. The St. Carlos gestational diabetes mellitus (GDM) prevention study, is a randomized controlled trial that evaluated the influence of the early (before 12th gestational week) Mediterranean diet (MedDiet) on the onset of GDM and adverse gestational outcomes. Out of 874 women assessed after delivery (440 control group (CG)/434 intervention group (IG)), 703 children were followed (365/338; CG/IG), with the aim to assess whether the adherence to a MedDiet during pregnancy induces health benefits for the offspring during the first two years of life. Logistic regression analysis showed that the IG in children of mothers with pre-gestational body mass index (BMI) < 25 kg/m 2  and normal glucose tolerance (NGT), was associated with a lower risk (RR(95% CI)) of suffering from severe events requiring hospitalization due to bronchiolitis/asthma (0.75(0.58-0.98) and 0.77(0.59-0.99), respectively) or other diseases that required either antibiotic (0.80(0.65-0.98) and 0.80(0.65-0.99), respectively), corticosteroid treatment (0.73(0.59-0.90) and 0.79(0.62-1.00) respectively) or both (all  p  < 0.05). A nutritional intervention based on the MedDiet during pregnancy is associated with a reduction in offspring's hospital admissions, especially in women with pre-gestational BMI < 25 kg/m 2  and NGT.",2020,"A nutritional intervention based on the MedDiet during pregnancy is associated with a reduction in offspring's hospital admissions, especially in women with pre-gestational BMI < 25 kg/m 2  and NGT.","['women with pre-gestational BMI < 25 kg/m 2  and NGT', '874 women assessed after delivery (440 control group (CG)/434 intervention group (IG)), 703 children']","['Mediterranean Diet Supplemented with Extra Virgin Olive Oil and Pistachios', 'Mediterranean diet (MedDiet']",['normal glucose tolerance (NGT'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0459819', 'cui_str': 'Pistachio nut'}]","[{'cui': 'C0860800', 'cui_str': 'Glucose normal'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]",874.0,0.0489339,"A nutritional intervention based on the MedDiet during pregnancy is associated with a reduction in offspring's hospital admissions, especially in women with pre-gestational BMI < 25 kg/m 2  and NGT.","[{'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Melero', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Assaf-Balut', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Nuria García de la', 'Initials': 'NG', 'LastName': 'Torre', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Inés', 'Initials': 'I', 'LastName': 'Jiménez', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Bordiú', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Laura Del', 'Initials': 'LD', 'LastName': 'Valle', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Valerio', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Familiar', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Durán', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Runkle', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'María Paz de', 'Initials': 'MP', 'LastName': 'Miguel', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Montañez', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Barabash', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Martín', 'Initials': 'M', 'LastName': 'Cuesta', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Herraiz', 'Affiliation': 'Facultad de Medicina. Medicina II Department, Universidad Complutense de Madrid, 28040, Madrid, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Izquierdo', 'Affiliation': 'Facultad de Medicina. Medicina II Department, Universidad Complutense de Madrid, 28040, Madrid, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Rubio', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Alfonso L', 'Initials': 'AL', 'LastName': 'Calle-Pascual', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}]",Journal of clinical medicine,['10.3390/jcm9051454']
1646,32414185,"ZeOxaNMulti Trial: A Randomized, Double-Blinded, Placebo-Controlled Trial of Oral PMA-zeolite to prevent Chemotherapy-Induced Side Effects, in particular, Peripheral Neuropathy.","Chemotherapy-induced peripheral neuropathy (CIPN) is the most frequently reported adverse effect of oxaliplatin. In this study, we set out to evaluate the role of the panaceo-micro-activation (PMA) zeolite in the reduction of the incidence of CIPN and hematological and liver toxicity. The possible impact of the PMA-zeolite as an adjuvant therapeutic agent is based on its detoxification properties toward agents promoting the development of neuropathy (e.g., ammonium - recognized as a neurotoxic agent produced by tumors), as well as its positive impact on immunity and oxidative stress through its effects in the gastrointestinal tract. From April 2015 to October 2018, a total of 120 patients (pts) diagnosed with predominantly colorectal cancer requiring oxaliplatin-based chemotherapy were randomized to receive either the PMA-zeolite (Multizeo Med) or placebo while undergoing oxaliplatin-based chemotherapy. A nerve-conduction study (NCS)&nbsp;was planned at the baseline, after three and six months of chemotherapy, to evaluate CIPN. Furthermore, the evaluation of hematological and liver toxicity was performed during every cycle of chemotherapy. 70.6% and 64.3% of patients developed CIPN in the placebo and the PMA-zeolite group, respectively. Patients treated with the PMA-zeolite were able to undergo more cycles of chemotherapy (p = 0.03), which also indicates a significant improvement in tolerance to the therapy. The group treated with the PMA-zeolite showed a lower CIPN (although not statistically significant within the whole group of subjects) compared to patients receiving placebo. This advantage was, however, statistically significant in men (p = 0.047). In addition, supplementation with the PMA-zeolite resulted in a lower incidence of severe-grade hematological toxicity (trend toward statistical significance of p = 0.09 was observed). Cancer patients may benefit from the therapy with the appropriate certified zeolite-products (e.g., the PMA-zeolite) for human use in CIPN. The lower CIPN (statistically significant results in the male subgroup) was accompanied by a trend of lower incidence of severe-grade hematological toxicity. Furthermore, these benefits led to a better tolerance toward chemotherapy (increase in cycles) and allow an improved compliance with the oncological treatment protocol.",2020,"Patients treated with the PMA-zeolite were able to undergo more cycles of chemotherapy (p = 0.03), which also indicates a significant improvement in tolerance to the therapy.","['From April 2015 to October 2018, a total of 120 patients (pts) diagnosed with predominantly colorectal cancer requiring', 'Cancer patients']","['PMA-zeolite (Multizeo Med) or placebo while undergoing oxaliplatin-based chemotherapy', 'oxaliplatin', 'Placebo', 'oxaliplatin-based chemotherapy', 'placebo']","['severe-grade hematological toxicity', 'lower CIPN', 'tolerance', 'CIPN', 'hematological and liver toxicity', 'CIPN and hematological and liver toxicity']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0078755', 'cui_str': 'Zeolite'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}]",120.0,0.052801,"Patients treated with the PMA-zeolite were able to undergo more cycles of chemotherapy (p = 0.03), which also indicates a significant improvement in tolerance to the therapy.","[{'ForeName': 'Maria Giuseppa', 'Initials': 'MG', 'LastName': 'Vitale', 'Affiliation': 'Medical Oncology Unit, University Hospital of Modena, 41125 Modena, Italy.'}, {'ForeName': 'Carmela', 'Initials': 'C', 'LastName': 'Barbato', 'Affiliation': 'Medical Oncology Unit, AORN Antonio Cardarelli, 80131 Naples, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Crispo', 'Affiliation': 'Epidemiology and Biostatistics Unit, Istituto Nazionale Tumori-IRCCS ""Fondazione G. Pascale"", 80131 Naples, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Habetswallner', 'Affiliation': 'UOC Neurofisiopatologia AORN Cardarelli, 80131 Naples, Italy.'}, {'ForeName': 'Bernardo Maria De', 'Initials': 'BM', 'LastName': 'Martino', 'Affiliation': 'UOC Neurofisiopatologia AORN Cardarelli, 80131 Naples, Italy.'}, {'ForeName': 'Ferdinando', 'Initials': 'F', 'LastName': 'Riccardi', 'Affiliation': 'Medical Oncology Unit, AORN Antonio Cardarelli, 80131 Naples, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Maione', 'Affiliation': 'Medical Oncology Unit, AORN Antonio Cardarelli, 80131 Naples, Italy.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Eisenwagen', 'Affiliation': 'Panaceo International GmbH, 9585 Goedersdorf, Austria.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Vitale', 'Affiliation': 'School of Medicine and Surgery, University of Campania Luigi Vanvitelli, 81100 Caserta, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Cartenì', 'Affiliation': 'Medical Oncology Unit, AORN Antonio Cardarelli, 80131 Naples, Italy.'}]","Molecules (Basel, Switzerland)",['10.3390/molecules25102297']
1647,32414901,Methylphenidate Effects on Cortical Thickness in Children and Adults with Attention-Deficit/Hyperactivity Disorder: A Randomized Clinical Trial.,"BACKGROUND AND PURPOSE


Although methylphenidate is frequently used to treat children with attention-deficit/hyperactivity disorder, it is currently unknown how methylphenidate affects brain development. In a randomized controlled trial, we investigated whether the cortical effects of methylphenidate are modulated by age.
MATERIALS AND METHODS


Between June 1, 2011, and June 15, 2015, we conducted a randomized, double-blind, placebo-controlled trial (Effects of Psychotropic Drugs on Developing Brain-Methylphenidate) in 99 males with attention-deficit/hyperactivity disorder (according to  Diagnostic and Statistical Manual of Mental Disorders, 4th Edition , criteria) from referral centers in the greater Amsterdam area in the Netherlands. The trial was registered on March 24, 2011 (identifier NL34509.000.10) and subsequently at the Netherlands National Trial Register (identifier NTR3103). Participants (first enrolled October 13, 2011) were 10-12 years or 23-40 years of age and randomized to treatment with either methylphenidate or a placebo for 16 weeks. Our main outcome was a change in cortical thickness in predefined ROIs as measured by MR imaging pre- and posttreatment.
RESULTS


We observed a time × medication × age interaction ( F [1,88.825] = 4.316,  P  < .05) for the right medial cortex ROI, where methylphenidate treatment yielded less cortical thinning in children, but not in adults or the placebo groups.
CONCLUSIONS


Our finding that the effects of methylphenidate on right medial cortical thickness differ between children and adults infers that the drug affects gray matter development in this brain region. This warrants replication in larger groups with longer follow-up to determine whether this effect can also be observed in other cortical brain regions and whether it may have long-term consequences.",2020,"We observed a time × medication × age interaction ( F [1,88.825] = 4.316,  P  < .05) for the right medial cortex ROI, where methylphenidate treatment yielded less cortical thinning in children, but not in adults or the placebo groups.
","['children with attention-deficit/hyperactivity disorder', 'Children and Adults with Attention-Deficit/Hyperactivity Disorder', 'Participants (first enrolled October 13, 2011) were 10-12\u2009years or 23-40\u2009years of age and randomized to treatment with either', '99 males with attention-deficit/hyperactivity disorder (according to  Diagnostic and Statistical Manual of Mental Disorders, 4th Edition , criteria) from referral centers in the greater Amsterdam area in the Netherlands']","['methylphenidate', 'Methylphenidate', 'Psychotropic Drugs', 'methylphenidate or a placebo', 'placebo']","['Cortical Thickness', 'right medial cortical thickness', 'cortical thinning', 'cortical thickness in predefined ROIs', 'Developing Brain-Methylphenidate']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}]",99.0,0.743922,"We observed a time × medication × age interaction ( F [1,88.825] = 4.316,  P  < .05) for the right medial cortex ROI, where methylphenidate treatment yielded less cortical thinning in children, but not in adults or the placebo groups.
","[{'ForeName': 'K B', 'Initials': 'KB', 'LastName': 'Walhovd', 'Affiliation': 'From the Department of Psychology (K.B.W., I.A., D.A.R., A.B., A.M.F.), Center for Lifespan Changes in Brain and Cognition.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Amlien', 'Affiliation': 'From the Department of Psychology (K.B.W., I.A., D.A.R., A.B., A.M.F.), Center for Lifespan Changes in Brain and Cognition.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Schrantee', 'Affiliation': 'Department of Radiology and Nuclear Medicine (A.S., A.B., L.R.), Amsterdam UMC, Academic Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Rohani', 'Affiliation': 'From the Department of Psychology (K.B.W., I.A., D.A.R., A.B., A.M.F.), Center for Lifespan Changes in Brain and Cognition.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Groote', 'Affiliation': 'Diagnostic Physics (I.G., A.B.), Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bjørnerud', 'Affiliation': 'From the Department of Psychology (K.B.W., I.A., D.A.R., A.B., A.M.F.), Center for Lifespan Changes in Brain and Cognition.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Fjell', 'Affiliation': 'From the Department of Psychology (K.B.W., I.A., D.A.R., A.B., A.M.F.), Center for Lifespan Changes in Brain and Cognition.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Reneman', 'Affiliation': 'Department of Radiology and Nuclear Medicine (A.S., A.B., L.R.), Amsterdam UMC, Academic Medical Center, Amsterdam, the Netherlands. l.reneman@amsterdamumc.nl.'}]",AJNR. American journal of neuroradiology,['10.3174/ajnr.A6560']
1648,32413530,Cranberry capsules are not superior to placebo capsules in managing acute non-haemorrhagic radiation cystitis in prostate cancer patients: A phase III double blinded randomised placebo controlled clinical trial.,"PURPOSE


Acute radiation cystitis affects the quality of life of many prostate cancer patients. A previous pilot study suggested that cranberry capsules may decrease some of the symptoms of acute radiation cystitis. Here we further test their effectiveness in a multicentre double blinded placebo-controlled clinical trial.
MATERIAL AND METHODS


A total of 108 prostate cancer patients were recruited at three New Zealand hospitals between September 2016 and January 2019. Out of this cohort, 101 patients provided datasets for analysis (51 men on cranberry capsules and 50 men on beetroot-containing placebo capsules). Patients took two capsules each morning during RT and for 2 weeks after completion of RT. Three measures were used to assess cystitis severity: modified RTOG, O'Leary interstitial cystitis scale and a sensitive novel radiation induced cystitis assessment scale (RICAS). Cystitis severity was scored at baseline and weekly thereafter during RT and for two weeks after completion of RT. Radiation protocols were stratified to conventional fractionation or hypo-fractionated radiation therapy (CHHiP) to the prostate or radiation to the prostate bed.
RESULTS


Cranberry capsules performed significantly worse than placebo capsules with respect to day time frequency and bladder control, using the more sensitive RICAS scale. No significant difference in cystitis severity was seen between patients receiving hypofractionation and those receiving conventional fractionation to the prostate gland.
CONCLUSION


Cranberry capsules were not superior to beetroot-containing placebo capsules in managing radiation cystitis in our prostate patient cohort. RICAS may be a useful tool for measuring radiation cystitis in future studies.",2020,"No significant difference in cystitis severity was seen between patients receiving hypofractionation and those receiving conventional fractionation to the prostate gland.
","['101 patients provided datasets for analysis (51 men on cranberry capsules and 50 men on beetroot-containing placebo capsules', 'many prostate cancer patients', 'prostate cancer patients', '108 prostate cancer patients were recruited at three New Zealand hospitals between September 2016 and January 2019']","['conventional fractionation or hypo-fractionated radiation therapy (CHHiP', 'Cranberry capsules', 'placebo capsules', 'RICAS', 'cranberry capsules', 'placebo']","['Cystitis severity', 'sensitive RICAS scale', 'symptoms of acute radiation cystitis', 'cystitis severity', ""cystitis severity: modified RTOG, O'Leary interstitial cystitis scale and a sensitive novel radiation induced cystitis assessment scale (RICAS""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0453112', 'cui_str': 'Beetroot'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0524811', 'cui_str': 'Dose Fractionation, Radiotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}]","[{'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0403637', 'cui_str': 'Acute radiation cystitis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0282488', 'cui_str': 'Ulcerative cystitis'}, {'cui': 'C0205314', 'cui_str': 'New'}]",108.0,0.254135,"No significant difference in cystitis severity was seen between patients receiving hypofractionation and those receiving conventional fractionation to the prostate gland.
","[{'ForeName': 'Patries M', 'Initials': 'PM', 'LastName': 'Herst', 'Affiliation': 'Department of Radiation Therapy, University of Otago, Wellington, New Zealand. Electronic address: patries.herst@otago.ac.nz.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Aumata', 'Affiliation': 'Radiation Oncology Department, Southern Blood and Cancer Centre, Dunedin Hospital, New Zealand.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Sword', 'Affiliation': 'Kathleen Kilgour Centre, Tauranga, New Zealand.'}, {'ForeName': 'Rowan', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Auckland Radiation Oncology, Epsom, New Zealand.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Purdie', 'Affiliation': ""Dean's Department, University of Otago, Wellington, New Zealand.""}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Costello', 'Affiliation': 'Radiation Oncology Department, Southern Blood and Cancer Centre, Dunedin Hospital, New Zealand.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.05.006']
1649,32413595,Double trouble: Do symptom severity and duration interact to predicting treatment outcomes in adolescent depression?,"Studies suggest that depression severity and duration interact to predict outcomes in depression treatment. To our knowledge, no study has explored this question in a sample with a placebo control, two therapies, and their combination nor with adolescents. We used data from the Treatment of Adolescent Depression Study (N = 439), in which adolescent were randomized to placebo (PBO), cognitive-behavioral therapy (CBT), antidepressants medications (MEDs), or their combination (COMB). We explore the interaction between depression severity, chronicity, and treatments (vs. placebo) in predicting outcomes. There was interaction between severity and chronicity when comparing COMB and CBT with PBO, but not MEDs. In non-chronic depression, the effects of CBT were inversely related to severity to the point that CBT appeared iatrogenic with more severe depression. In chronic depression, the effects of CBT did not vary by severity, but the relative effects of COMB grew, being smallest in milder, more dysthymic-like depression, and largest in chronic-severe depression. These findings support calls to classify depression by severity and chronicity as well efforts to risk stratify patients to different intensity of care according to these variables.",2020,"In non-chronic depression, the effects of CBT were inversely related to severity to the point that CBT appeared iatrogenic with more severe depression.",['Adolescent Depression Study (N\xa0=\xa0439'],"['CBT', 'placebo (PBO), cognitive-behavioral therapy (CBT), antidepressants medications (MEDs), or their combination (COMB', 'placebo']",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",[],,0.0183832,"In non-chronic depression, the effects of CBT were inversely related to severity to the point that CBT appeared iatrogenic with more severe depression.","[{'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Lorenzo-Luaces', 'Affiliation': 'Department of Psychological and Brain Sciences, Indiana University, Bloomington, IN, USA. Electronic address: lolorenz@indiana.edu.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Rodriguez-Quintana', 'Affiliation': 'Department of Psychological and Brain Sciences, Indiana University, Bloomington, IN, USA.'}, {'ForeName': 'Allen J', 'Initials': 'AJ', 'LastName': 'Bailey', 'Affiliation': 'Department of Psychological and Brain Sciences, Indiana University, Bloomington, IN, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103637']
1650,32416495,Changing the future: An initial test of Future Specificity Training (FeST).,"A range of psychiatric disorders are characterised by impairments in episodic future thinking (EFT), and particularly simulating specific, spatiotemporally-located future events. No study has examined whether training can lead to sustained improvement in specific EFT. In this study, participants (N = 60; M age = 31, SD = 13.2) were randomized to a two-session, group-based future thinking program (Future Specificity Training; FeST) or wait-list. At follow-up the training group, relative to wait-list, showed large, statistically-significant improvements in the ability to mentally simulate specific EFT (d = .82), increases in detail (d = 1.32), use of mental imagery (d = 1.32), anticipated (d = 1.78) and anticipatory pleasure (d = 1.07), perceived control (d = 1.20), and likelihood of occurrence (d = 1.09). Some effects were also observed on positive, generalised future self-states. In the context of inherent limitations of subjective reporting in trials, this study provides evidence that EFT specificity can be enhanced, and the effects of FeST indicate a possible avenue to disrupt psychopathological processes.",2020,"At follow-up the training group, relative to wait-list, showed large, statistically-significant improvements in the ability to mentally simulate specific EFT (d = .82), increases in detail (","['participants (N\xa0=\xa060; M age\xa0=\xa031, SD\xa0=\xa013.2']","['group-based future thinking program (Future Specificity Training; FeST) or wait-list', 'Future Specificity Training (FeST']","['anticipatory pleasure', 'detail ', 'ability to mentally simulate specific EFT']","[{'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0016884', 'cui_str': 'Future'}]",,0.0143698,"At follow-up the training group, relative to wait-list, showed large, statistically-significant improvements in the ability to mentally simulate specific EFT (d = .82), increases in detail (","[{'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Hallford', 'Affiliation': 'School of Psychology, Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125, Melbourne, Australia. Electronic address: david.hallford@deakin.edu.au.'}, {'ForeName': 'J J E', 'Initials': 'JJE', 'LastName': 'Yeow', 'Affiliation': 'School of Psychology, Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125, Melbourne, Australia.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Fountas', 'Affiliation': 'School of Psychology, Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125, Melbourne, Australia.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Herrick', 'Affiliation': 'School of Psychology, Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125, Melbourne, Australia.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Raes', 'Affiliation': 'Faculty of Psychology and Educational Sciences, KU Leuven, Tiensestraat 102, Box 3712, 3000, Leuven, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': ""D'Argembeau"", 'Affiliation': 'Psychology and Neuroscience of Cognition Research Unit, Department of Psychology, University of Liège, Belgium and Fonds de La Recherche Scientifique (F.R.S.-FNRS), Belgium.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103638']
1651,32415720,"The first-in-human study of CNTO 7160, an anti-interleukin-33 receptor monoclonal antibody, in healthy subjects and patients with asthma or atopic dermatitis.","AIMS


To assess safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of CNTO 7160, an anti-interleukin-33 receptor (IL-33R) monoclonal antibody, in healthy subjects and patients with asthma or atopic dermatitis (AD).
METHODS


In Part 1 of this Phase I, randomized, double-blind, placebo-controlled study, healthy subjects (n = 68) received single ascending intravenous (IV) CNTO 7160 dose (0.001 to 10 mg/kg) or placebo. In Part 2, patients with mild asthma (n = 24) or mild AD (n = 15) received 3 biweekly IV CNTO 7160 doses (3 or 10 mg/kg) or placebo.
RESULTS


CNTO 7160 was generally well tolerated, with 1 serious adverse event of severe cellulitis reported (AD, CNTO 7160, 3 mg/kg). CNTO 7160 exhibited nonlinear PK (0.01-10 mg/kg). Mean clearance decreased with increasing dose (2.43 to 18.03 mL/d/kg). CNTO 7160 PK was similar between healthy subjects and patients with asthma or AD (3 or 10 mg/kg). Free sIL-33R suppression was rapid and dose dependent. Ex vivo inhibition of p38 phosphorylation of basophils was dose-dependent (1-10 mg/kg) and sustained inhibition (≥75%) was observed at higher doses (3 or 10 mg/kg). PK/PD modelling and simulation suggests that 1 mg/kg IV every 2 weeks provides adequate systemic drug exposure for sustained inhibition of p38 phosphorylation of basophils. Despite confirmation of target engagement, no apparent CNTO 7160 clinical activity was observed in patients (asthma or AD).
CONCLUSION


This first-in-human study provides PK, PD and safety data, supporting further clinical investigation of CNTO 7160 in patients with asthma and AD.",2020,Ex-vivo inhibition of p38 phosphorylation of basophils was dose-dependent (1 to 10 mg kg -1  ) and sustained inhibition (≥75%) was observed at higher doses (3 or 10 mg kg -1  ).,"['healthy subjects and patients with asthma or AD', 'patients (asthma or AD', 'healthy subjects (n=68) received', 'patients with asthma and AD', 'healthy subjects and patients with asthma or atopic dermatitis (AD', 'patients with mild asthma (n=24) or mild AD (n=15', 'Healthy Subjects and Patients with Asthma or Atopic Dermatitis']","['single ascending intravenous (IV) CNTO', 'placebo']","['safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity', 'Mean clearance', 'Free sIL-33R suppression']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0581124', 'cui_str': 'Mild asthma'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0257766', 'cui_str': 'SILV protein, human'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]",7160.0,0.162099,Ex-vivo inhibition of p38 phosphorylation of basophils was dose-dependent (1 to 10 mg kg -1  ) and sustained inhibition (≥75%) was observed at higher doses (3 or 10 mg kg -1  ).,"[{'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Nnane', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Frederick', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Zhenling', 'Initials': 'Z', 'LastName': 'Yao', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Raible', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Cathye', 'Initials': 'C', 'LastName': 'Shu', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Badorrek', 'Affiliation': 'Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), Clinical Airway Research, Nikolai-Fuchs-Strasse 1, Hannover, 30625, Germany.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'van den Boer', 'Affiliation': 'Janssen Research & Development, LLC, Merksem, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Branigan', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Duffy', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Baribaud', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Fink', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Tong-Yuan', 'Initials': 'TY', 'LastName': 'Yang', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Zhenhua', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}]",British journal of clinical pharmacology,['10.1111/bcp.14361']
1652,31814307,Influence of placebo effects on quality of life and wound healing in patients with chronic venous leg ulcers.,"INTRODUCTION


Placebo effects are used in the treatment of various medical conditions. To date, there is little scientific data in this regard as it relates to skin diseases in general and hardly any data with respect to wound healing in particular.
MATERIAL AND METHODS


In a prospective randomized controlled trial, patients with chronic venous leg ulcers were observed for a period of 14 weeks. The objective was to investigate whether raising patients' expectations with regard to a novel wound treatment might have an effect on wound healing processes as well as wound-related quality of life, anxiety, depression and pain.
RESULTS


Overall, 20 patients were included in the trial. They were stratified based on gender and randomized to either the intervention (IG) or the control group (CG). In both groups, the wound area decreased significantly over the course of the observation period. Unlike patients in the CG, those in the IG experienced significant improvement in wound-related quality of life (wound-QoL) in terms of both the overall score and the various subscales. Neither group showed significant changes with respect to pain, anxiety and depression.
CONCLUSIONS


Our study is the first to show that - merely by raising patients' expectations for a novel treatment - placebo effects can significantly improve quality of life in patients with chronic venous leg ulcers. In the future, our findings should be integrated into the development of treatment concepts for patients with chronic wounds and should be investigated in larger cohorts.",2020,"Neither group showed significant changes with respect to pain, anxiety and depression.
","['20 patients were included in the trial', 'patients with chronic wounds', 'patients with chronic venous leg ulcers']",['placebo'],"['wound-related quality of life (wound-QoL', 'quality of life', 'wound area', 'pain, anxiety and depression', 'quality of life and wound healing']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0023223', 'cui_str': 'Leg Ulcer'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0034380'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}]",,0.029819,"Neither group showed significant changes with respect to pain, anxiety and depression.
","[{'ForeName': 'Finja', 'Initials': 'F', 'LastName': 'Jockenhöfer', 'Affiliation': 'Department of Dermatology, Venereology and Allergology, University Medical Center, Essen, Germany.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Knust', 'Affiliation': 'Department of Dermatology, Venereology and Allergology, University Medical Center, Essen, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Benson', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Medical Center, Essen, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Schedlowski', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Medical Center, Essen, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Dissemond', 'Affiliation': 'Department of Dermatology, Venereology and Allergology, University Medical Center, Essen, Germany.'}]",Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG,['10.1111/ddg.13996']
1653,27051621,What happens to the hemodynamic responses for laryngeal mask airway insertion when we supplement propofol with butorphanol or fentanyl for induction of anesthesia: A comparative assessment and critical review.,"BACKGROUND


There is a delicate balance between respiratory tract anatomy, its physiology, physiological response to anesthetic agents, and airway management. The traditional gadgets to secure airway are face masks or endotracheal tubes. Recently, laryngeal mask airway (LMA) is gaining popularity. It does not require laryngoscopy thereby minimizing hemodynamic responses. For LMA placement, propofol is the induction agent of choice. Propofol, when used alone, requires large doses and leads to undesirable cardiorespiratory depression. To culminate its dose, various adjuncts are combined with it.
AIM


Comparison of hemodynamic response of LMA using either butorphanol or fentanyl (according to group allocated) in combination with propofol.
METHODOLOGY


Hundred patients scheduled for various surgical procedures were randomly selected and divided into two groups of 50 patients each, Group F (propofol and fentanyl) and Group B (propofol and butorphanol). One minute after giving intravenous (IV) opioids, induction was achieved with IV propofol 2.5 mg/kg. Depth of anesthesia was assessed, and LMA was inserted. Hemodynamic variables were measured before premedication, after premedication; 1, 3, and 5 min after insertion and after extubation of LMA.
RESULTS


After insertion of LMA, statistically significant drop in mean heart rate, systolic blood pressure (BP), diastolic BP, and mean BP was noted in Group F as compared to Group B (P < 0.05).
CONCLUSION


The use of propofol-butorphanol combination produces stable hemodynamics as compared to propofol-fentanyl combination.",2016,"After insertion of LMA, statistically significant drop in mean heart rate, systolic blood pressure (BP), diastolic BP, and mean BP was noted in Group F as compared to Group B (P < 0.05).
",['Hundred patients scheduled for various surgical procedures'],"['Propofol', 'propofol-butorphanol', 'propofol', 'Group F (propofol and fentanyl) and Group B (propofol and butorphanol', 'butorphanol or fentanyl', 'propofol with butorphanol or fentanyl', 'laryngeal mask airway (LMA', 'LMA']","['mean heart rate, systolic blood pressure (BP), diastolic BP, and mean BP', 'Hemodynamic variables']","[{'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0006491', 'cui_str': 'Butorphanol'}, {'cui': 'C0441840', 'cui_str': 'Group F (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}]",0.0,0.0163422,"After insertion of LMA, statistically significant drop in mean heart rate, systolic blood pressure (BP), diastolic BP, and mean BP was noted in Group F as compared to Group B (P < 0.05).
","[{'ForeName': 'Manisha Bhatt', 'Initials': 'MB', 'LastName': 'Dwivedi', 'Affiliation': 'Department of Anaesthesiology and Critical Care, MMIMSR, Mullana-Ambala, Haryana, India.'}, {'ForeName': 'Manda', 'Initials': 'M', 'LastName': 'Nagrale', 'Affiliation': 'Department of Anaesthesiology and Critical Care, JNMC, Sawangi, Meghem, Wardha, Maharashtra, India.'}, {'ForeName': 'Sankalp', 'Initials': 'S', 'LastName': 'Dwivedi', 'Affiliation': 'Department of Anaesthesiology and Critical Care, MMIMSR, Mullana-Ambala, Haryana, India.'}, {'ForeName': 'Hardeep', 'Initials': 'H', 'LastName': 'Singh', 'Affiliation': 'Department of Anaesthesiology and Critical Care, MMIMSR, Mullana-Ambala, Haryana, India.'}]",International journal of critical illness and injury science,['10.4103/2229-5151.177369']
1654,32492293,A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19.,"BACKGROUND


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


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


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


After high-risk or moderate-risk exposure to Covid-19, hydroxychloroquine did not prevent illness compatible with Covid-19 or confirmed infection when used as postexposure prophylaxis within 4 days after exposure. (Funded by David Baszucki and Jan Ellison Baszucki and others; ClinicalTrials.gov number, NCT04308668.).",2020,"Side effects were more common with hydroxychloroquine than with placebo (40.1% vs. 16.8%), but no serious adverse reactions were reported.
","['United States and parts of Canada testing', '821 asymptomatic participants', 'enrolled adults who had household or occupational exposure to someone with confirmed Covid-19 at a distance of less than 6 ft for more than 10 minutes while wearing neither a face mask nor an eye shield (high-risk exposure) or while wearing a face mask but no eye shield (moderate-risk exposure']","['placebo', 'Hydroxychloroquine', 'placebo or hydroxychloroquine', 'hydroxychloroquine']","['Side effects', 'incidence of new illness compatible with Covid-19', 'incidence of either laboratory-confirmed Covid-19 or illness compatible with Covid-19 within 14 days', 'serious adverse reactions']","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0454979', 'cui_str': 'Part of Canada'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0028798', 'cui_str': 'Exposure, Occupational'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0183251', 'cui_str': 'Shield'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",821.0,0.751633,"Side effects were more common with hydroxychloroquine than with placebo (40.1% vs. 16.8%), but no serious adverse reactions were reported.
","[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Boulware', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Pullen', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Ananta S', 'Initials': 'AS', 'LastName': 'Bangdiwala', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Katelyn A', 'Initials': 'KA', 'LastName': 'Pastick', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Lofgren', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Okafor', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Caleb P', 'Initials': 'CP', 'LastName': 'Skipper', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Alanna A', 'Initials': 'AA', 'LastName': 'Nascene', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Melanie R', 'Initials': 'MR', 'LastName': 'Nicol', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Abassi', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Nicole W', 'Initials': 'NW', 'LastName': 'Engen', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Cheng', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'LaBar', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Sylvain A', 'Initials': 'SA', 'LastName': 'Lother', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'MacKenzie', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Drobot', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Marten', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Zarychanski', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Kelly', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Ilan S', 'Initials': 'IS', 'LastName': 'Schwartz', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Emily G', 'Initials': 'EG', 'LastName': 'McDonald', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Rajasingham', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Lee', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Kathy H', 'Initials': 'KH', 'LastName': 'Hullsiek', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}]",The New England journal of medicine,['10.1056/NEJMoa2016638']
1655,32492600,Cross-fading motives for simultaneous alcohol and marijuana use: Associations with young adults' use and consequences across days.,"BACKGROUND


Many young adults engage in simultaneous alcohol and marijuana (SAM) use so that their effects overlap. Little is known about motivations for dual substance use and associations with use and consequences. This study examined daily-level associations between cross-fading motives and levels of alcohol and marijuana use and consequences.
METHODS


Young adults who reported SAM use in the month prior were surveyed in two 14-day bursts. Data included 1049 SAM use days from 281 young adults (age 18-25; M age = 21.80, SD = 2.16; 50 % women). Multilevel models assessed between- and within-person effects of cross-fading motives (i.e., to enhance the effects of marijuana and/or alcohol use by using them simultaneously) on alcohol and marijuana use and consequences, after adjusting for general enhancement, social, coping, and conformity motives and the amount of alcohol and marijuana used that day.
RESULTS


On 76 % of SAM use days, participants endorsed cross-fading motives (i.e., to enhance the effect of alcohol or marijuana or to get drunk and high at the same time). Having stronger cross-fading motives was associated with greater alcohol use, perceived intoxication, and positive alcohol consequences at the between- and within-person levels. In addition, between-person, individuals who reported stronger cross-fading motives on average reported more negative alcohol consequences and positive marijuana consequences on average. Cross-fading motives on a given day were not associated with marijuana use or marijuana consequences that day.
CONCLUSIONS


Cross-fading motives were common and varied from day to day. Understanding the motivational context for dual substance use may support future interventions for cross-fading.",2020,"Cross-fading motives on a given day were not associated with marijuana use or marijuana consequences that day.
","['Data included 1049 SAM use days from 281 young adults (age 18-25; M age = 21.80, SD = 2.16; 50 % women', 'Young adults who reported SAM use in the month prior were surveyed in two 14-day bursts']",[],['negative alcohol consequences and positive marijuana consequences'],"[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0024810', 'cui_str': 'Marihuana Smoking'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C4517627', 'cui_str': '2.16'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}]",[],"[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}]",1049.0,0.0152649,"Cross-fading motives on a given day were not associated with marijuana use or marijuana consequences that day.
","[{'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Patrick', 'Affiliation': ""Institute for Translational Research in Children's Mental Health and Institute of Child Development, University of Minnesota, 1100 Washington Ave S., Suite 101, Minneapolis, MN 55415, USA. Electronic address: mpatrick@umn.edu.""}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Fleming', 'Affiliation': 'University of Washington, Department of Psychiatry and Behavioral Sciences, 1100 NE 45th St., Suite 300, Seattle, WA, 98105, USA.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Fairlie', 'Affiliation': 'University of Washington, Department of Psychiatry and Behavioral Sciences, 1100 NE 45th St., Suite 300, Seattle, WA, 98105, USA.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Lee', 'Affiliation': 'University of Washington, Department of Psychiatry and Behavioral Sciences, 1100 NE 45th St., Suite 300, Seattle, WA, 98105, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108077']
1656,27308256,A comparison of ketamine versus etomidate for procedural sedation for the reduction of large joint dislocations.,"STUDY OBJECTIVES


Ketamine and etomidate are used for procedural sedation (PS) to facilitate the performance of painful procedures. We hypothesized that ketamine produces adequate and comparable sedation conditions for dislocated large joint reduction when compared to etomidate and results in fewer adverse events.
METHODS


This Institutional Review Board approved prospective trial compared a convenience sample of subjects, who were randomized to receive either ketamine or etomidate for PS to facilitate reduction of large joint dislocations. Following informed consent, subjects were assigned via a computer-generated algorithm to receive either etomidate (0.1 mg/kg) or ketamine (0.5 mg/kg) intravenously; if PS was not sufficient, subjects received repeat doses of etomidate or ketamine until adequate PS was achieved. The protocol's primary endpoint was a successful reduction of dislocated, large joints. Secondary endpoints included alteration in blood pressure, vomiting, recovery agitation, hypersalivation, laryngospasm, myoclonus, hypoxia, airway assistance with chin lift or jaw thrust, bag-valve-mask ventilation, endotracheal intubation, utilization of additional doses of ketamine or etomidate, and recovery time from sedation.
RESULTS


Total enrollment was eighty subjects, 46 in the ketamine cohort and 34 in the etomidate cohort. The two PS groups were comparable in terms of gender, age, and weight. There was no significant difference in the primary endpoint of large joint dislocation reduction between the ketamine and etomidate cohorts (46/46, 100%; 32/34, 94.1%; P - 0.1). Shoulder, hip, and ankle joints account for the majority of joint reductions in this trial. Titration of PS was necessary for almost half of each cohort as evidenced by the utilization of additional dosages of the sedative agents: ketamine (22/46, 47.8%) and etomidate (14/34, 41.2%; P - 0.56). Among secondary outcome variables, significant differences between ketamine and etomidate cohorts were myoclonus (1/46, 2.2%, 15/33, 45.5%; P - 0.0001), assisted ventilation with airway manipulation (3/45, 6.7%; 9/33, 27.3%; P - 0.01), and pulsoximetry desaturation < 90% (0/46; 7/34, 20.6%; P - 0.002). There was no significant difference in recovery time from PS between the ketamine and etomidate cohorts (11 min vs. 10 min; P - 0.69).
CONCLUSION


Ketamine produces PS conditions for successful large joint dislocation reduction that are adequate and comparable to etomidate. The increased likelihood of myoclonus, of the requirement for airway assistance, and of hypoxia observed with etomidate suggest potential benefits with the utilization of ketamine for PS for dislocated large joint reduction.",2016,"Titration of PS was necessary for almost half of each cohort as evidenced by the utilization of additional dosages of the sedative agents: ketamine (22/46, 47.8%) and etomidate (14/34, 41.2%; P - 0.56).","['Total enrollment was eighty subjects, 46 in the ketamine cohort and 34 in the etomidate cohort', 'convenience sample of subjects']","['etomidate or ketamine', 'Ketamine and etomidate', 'ketamine', 'Ketamine', 'etomidate', 'ketamine or etomidate']","['large joint dislocation reduction', 'alteration in blood pressure, vomiting, recovery agitation, hypersalivation, laryngospasm, myoclonus, hypoxia, airway assistance with chin lift or jaw thrust, bag-valve-mask ventilation, endotracheal intubation, utilization of additional doses of ketamine or etomidate, and recovery time from sedation', 'pulsoximetry desaturation', 'successful reduction of dislocated, large joints', 'assisted ventilation with airway manipulation', 'recovery time from PS']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0015131', 'cui_str': 'Etomidate'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0015131', 'cui_str': 'Etomidate'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0559697', 'cui_str': 'Reduction of dislocation'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0037036', 'cui_str': 'Hypersalivation'}, {'cui': 'C0023066', 'cui_str': 'Laryngospasm'}, {'cui': 'C0027066', 'cui_str': 'Myoclonic Jerk'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0396611', 'cui_str': 'Chin lift (procedure)'}, {'cui': 'C0396612', 'cui_str': 'Jaw thrust (procedure)'}, {'cui': 'C1960845', 'cui_str': 'Bag valve mask ventilation (procedure)'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0015131', 'cui_str': 'Etomidate'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}]",,0.053101,"Titration of PS was necessary for almost half of each cohort as evidenced by the utilization of additional dosages of the sedative agents: ketamine (22/46, 47.8%) and etomidate (14/34, 41.2%; P - 0.56).","[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Salen', 'Affiliation': ""Department of Emergency Medicine, St. Luke's University Hospital, Bethlehem, PA 18015, USA.""}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Grossman', 'Affiliation': 'Department of General Surgery and Emergency Medicine, Southside Hospital, North Shore-LIJ Hospital Network, NY 11706, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Grossman', 'Affiliation': 'Department of General Surgery and Emergency Medicine, Southside Hospital, North Shore-LIJ Hospital Network, NY 11706, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Milazzo', 'Affiliation': ""Department of Emergency Medicine, St. Luke's University Hospital, Bethlehem, PA 18015, USA.""}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Stoltzfus', 'Affiliation': ""Department of Emergency Medicine, St. Luke's University Hospital, Bethlehem, PA 18015, USA.""}]",International journal of critical illness and injury science,['10.4103/2229-5151.183022']
1657,27401564,Population Pharmacokinetics of Fluconazole in Premature Infants with Birth Weights Less than 750 Grams.,"Fluconazole is an effective agent for prophylaxis of invasive candidiasis in premature infants. The objective of this study was to characterize the population pharmacokinetics (PK) and dosing requirements of fluconazole in infants with birth weights of <750 g. As part of a randomized clinical trial, infants born at <750 g birth weight received intravenous (i.v.) or oral fluconazole at 6 mg/kg of body weight twice weekly. Fluconazole plasma concentrations from samples obtained by either scheduled or scavenged sampling were measured using a liquid chromatography-tandem mass spectrometry assay. Population PK analysis was conducted using NONMEM 7.2. Population PK parameters were allometrically scaled by body weight. Covariates were evaluated by univariable screening followed by multivariable assessment. Fluconazole exposures were simulated in premature infants using the final PK model. A population PK model was developed from 141 infants using 604 plasma samples. Plasma fluconazole PK were best described by a one-compartment model with first-order elimination. Only serum creatinine was an independent predictor for clearance in the final model. The typical population parameter estimate for oral bioavailability in the final model was 99.5%. Scavenged samples did not bias the parameter estimates and were as informative as scheduled samples. Simulations indicated that the study dose maintained fluconazole troughs of >2,000 ng/ml in 80% of simulated infants at week 1 and 59% at week 4 of treatment. Developmental changes in fluconazole clearance are best predicted by serum creatinine in this population. A twice-weekly dose of 6 mg/kg achieves appropriate levels for prevention of invasive candidiasis in extremely premature infants.",2016,Scavenged samples did not bias the parameter estimates and were as informative as scheduled samples.,"['premature infants using the final PK model', 'extremely premature infants', '141 infants using 604 plasma samples', 'infants with birth weights of <750 g', 'premature infants', 'Premature Infants with Birth Weights Less than 750 Grams', 'infants born at <750 g birth weight received']","['fluconazole', 'intravenous (i.v.) or oral fluconazole', 'Fluconazole']","['oral bioavailability', 'Fluconazole plasma concentrations']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C3494262', 'cui_str': 'Extremely Preterm Infants'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}]","[{'cui': 'C0016277', 'cui_str': 'Fluconazole'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0306005,Scavenged samples did not bias the parameter estimates and were as informative as scheduled samples.,"[{'ForeName': 'Jeremiah D', 'Initials': 'JD', 'LastName': 'Momper', 'Affiliation': 'University of California, San Diego, La Jolla, California, USA.'}, {'ForeName': 'Edmund V', 'Initials': 'EV', 'LastName': 'Capparelli', 'Affiliation': 'University of California, San Diego, La Jolla, California, USA.'}, {'ForeName': 'Kelly C', 'Initials': 'KC', 'LastName': 'Wade', 'Affiliation': ""Children's Hospital of Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Kantak', 'Affiliation': ""Children's Hospital Medical Center of Akron, Akron, Ohio, USA.""}, {'ForeName': 'Ramasubbareddy', 'Initials': 'R', 'LastName': 'Dhanireddy', 'Affiliation': 'University of Tennessee Health System, Memphis, Tennessee, USA.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Cummings', 'Affiliation': 'East Carolina University, Brody School of Medicine, Greenville, North Carolina, USA.'}, {'ForeName': 'Jonathan H', 'Initials': 'JH', 'LastName': 'Nedrelow', 'Affiliation': ""Cook Children's Medical Center, Fort Worth, Texas, USA.""}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Hudak', 'Affiliation': 'University of Florida College of Medicine, Jacksonville, Florida, USA.'}, {'ForeName': 'Gratias T', 'Initials': 'GT', 'LastName': 'Mundakel', 'Affiliation': 'Kings County Hospital, Brooklyn, New York, USA.'}, {'ForeName': 'Girija', 'Initials': 'G', 'LastName': 'Natarajan', 'Affiliation': 'Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Laughon', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'P Brian', 'Initials': 'PB', 'LastName': 'Smith', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA Duke Clinical Research Institute, Durham, North Carolina, USA brian.smith@duke.edu.'}, {'ForeName': 'Daniel K', 'Initials': 'DK', 'LastName': 'Benjamin', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA Duke Clinical Research Institute, Durham, North Carolina, USA.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.00963-16']
1658,32415802,The effects of canagliflozin compared to sitagliptin on cardiorespiratory fitness in type 2 diabetes mellitus and heart failure with reduced ejection fraction: The CANA-HF study.,"BACKGROUND


Canagliflozin reduces hospitalizations for heart failure (HF) in type 2 diabetes mellitus (T2DM). Its effect on cardiorespiratory fitness and cardiac function in patients with established HF with reduced ejection fraction (HFrEF) is unknown.
METHODS


We conducted a double-blind randomized controlled trial of canagliflozin 100 mg or sitagliptin 100 mg daily for 12 weeks in 88 patients, and measured peak oxygen consumption (VO 2  ) and minute ventilation/carbon dioxide production (VE/VCO 2  ) slope (co-primary endpoints for repeated measure ANOVA time_x_group interaction), lean peak VO 2  , ventilatory anaerobic threshold (VAT), cardiac function and quality of life (ie, Minnesota Living with Heart Failure Questionnaire [MLHFQ]), at baseline and 12-week follow-up.
RESULTS


The study was terminated early due to the new guidelines recommending canagliflozin over sitagliptin in HF: 17 patients were assigned to canagliflozin and 19 to sitagliptin, total of 36 patients. There were no significant changes in peak VO 2  and VE/VCO 2  slope between the two groups (P = .083 and P = .98, respectively). Canagliflozin improved lean peak VO 2  (+2.4 mL kg LM   -1  min -1  , P = .036), VAT (+1.5 mL kg -1  min -1  , P = .012) and VO 2  matched for respiratory exchange ratio (+2.4 mL Kg -1  min -1  , P = .002) compared to sitagliptin. Canagliflozin also reduced MLHFQ score (-12.1, P = .018).
CONCLUSIONS


In this small and short-term study of patients with T2DM and HFrEF, interrupted early after only 36 patients, canagliflozin did not improve the primary endpoints of peak VO 2  or VE/VCO 2  slope compared to sitagliptin, while showing favourable trends observed on several additional surrogate endpoints such as lean peak VO 2  , VAT and quality of life.",2020,"Canagliflozin also reduced MLHFQ score (-12.1, P = 0.018).
","['patients with established HF with reduced ejection fraction (HFrEF', 'type 2 diabetes mellitus (T2DM', 'Type 2 Diabetes Mellitus and Heart Failure with Reduced Ejection Fraction']","['canagliflozin 100\u2009mg or sitagliptin', 'Sitagliptin', 'Canagliflozin', 'canagliflozin']","['cardiorespiratory fitness (CRF) and cardiac function', 'peak oxygen consumption (VO 2  ) and minute ventilation/carbon dioxide production (VE/VCO 2  ) slope (co-primary endpoints for repeated measure ANOVA time_x_group interaction), lean peak VO 2  , ventilatory anaerobic threshold (VAT), cardiac function and quality of life (ie, Minnesota Living with Heart Failure Questionnaire [MLHFQ', 'peak VO 2  and VE/VCO 2  slope', 'lean peak VO', 'VAT', 'MLHFQ score', 'lean peak VO 2  , VAT and quality of life', 'peak VO 2  or VE/VCO 2  slope', 'Cardiorespiratory Fitness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C3556569', 'cui_str': 'canagliflozin 100 MG [Invokana]'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}]","[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0002780', 'cui_str': 'Analysis, Variance'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042427', 'cui_str': 'Vatican City'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",36.0,0.0961832,"Canagliflozin also reduced MLHFQ score (-12.1, P = 0.018).
","[{'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Carbone', 'Affiliation': 'Department of Kinesiology & Health Sciences, College of Humanities & Sciences, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Hayley E', 'Initials': 'HE', 'LastName': 'Billingsley', 'Affiliation': 'Department of Kinesiology & Health Sciences, College of Humanities & Sciences, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Canada', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, VCU Pauley Heart Center, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Bressi', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, VCU Pauley Heart Center, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Brando', 'Initials': 'B', 'LastName': 'Rotelli', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, VCU Pauley Heart Center, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Kadariya', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, VCU Pauley Heart Center, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Dave L', 'Initials': 'DL', 'LastName': 'Dixon', 'Affiliation': 'Department of Pharmacotherapy and & Outcomes Science, School of Pharmacy, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Roshanak', 'Initials': 'R', 'LastName': 'Markley', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, VCU Pauley Heart Center, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Cory R', 'Initials': 'CR', 'LastName': 'Trankle', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, VCU Pauley Heart Center, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Cooke', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, VCU Pauley Heart Center, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Krishnasree', 'Initials': 'K', 'LastName': 'Rao', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, VCU Pauley Heart Center, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Keyur', 'Initials': 'K', 'LastName': 'B Shah', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, VCU Pauley Heart Center, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Horacio', 'Initials': 'H', 'LastName': 'Medina de Chazal', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, VCU Pauley Heart Center, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Juan Guido', 'Initials': 'JG', 'LastName': 'Chiabrando', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, VCU Pauley Heart Center, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Vecchié', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, VCU Pauley Heart Center, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Dell', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, VCU Pauley Heart Center, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'L Mihalick', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, VCU Pauley Heart Center, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Bogaev', 'Affiliation': 'Advanced Heart Failure Center, Bon Secours Heart & Vascular Institute, Richmond, Virginia, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Hart', 'Affiliation': 'Advanced Heart Failure Center, Bon Secours Heart & Vascular Institute, Richmond, Virginia, USA.'}, {'ForeName': 'Benjamin W', 'Initials': 'BW', 'LastName': 'Van Tassell', 'Affiliation': 'Department of Pharmacotherapy and & Outcomes Science, School of Pharmacy, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Arena', 'Affiliation': 'Department of Physical Therapy, College of Applied Health Sciences, University of Illinois at Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Francesco S', 'Initials': 'FS', 'LastName': 'Celi', 'Affiliation': 'Division of Endocrinology Diabetes and Metabolism, Department of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Abbate', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, VCU Pauley Heart Center, Virginia Commonwealth University, Richmond, Virginia, USA.'}]",Diabetes/metabolism research and reviews,['10.1002/dmrr.3335']
1659,32492302,"Rituximab for High-Risk, Mature B-Cell Non-Hodgkin's Lymphoma in Children.","BACKGROUND


Rituximab added to chemotherapy prolongs survival among adults with B-cell cancer. Data on its efficacy and safety in children with high-grade, mature B-cell non-Hodgkin's lymphoma are limited.
METHODS


We conducted an open-label, international, randomized, phase 3 trial involving patients younger than 18 years of age with high-risk, mature B-cell non-Hodgkin's lymphoma (stage III with an elevated lactate dehydrogenase level or stage IV) or acute leukemia to compare the addition of six doses of rituximab to standard lymphomes malins B (LMB) chemotherapy with standard LMB chemotherapy alone. The primary end point was event-free survival. Overall survival and toxic effects were also assessed.
RESULTS


Analyses were based on 328 patients who underwent randomization (164 patients per group); 85.7% of the patients had Burkitt's lymphoma. The median follow-up was 39.9 months. Events were observed in 10 patients in the rituximab-chemotherapy group and in 28 in the chemotherapy group. Event-free survival at 3 years was 93.9% (95% confidence interval [CI], 89.1 to 96.7) in the rituximab-chemotherapy group and 82.3% (95% CI, 75.7 to 87.5) in the chemotherapy group (hazard ratio for primary refractory disease or first occurrence of progression, relapse after response, death from any cause, or second cancer, 0.32; 95% CI, 0.15 to 0.66; one-sided P = 0.00096, which reached the significance level required for this analysis). Eight patients in the rituximab-chemotherapy group died (4 deaths were disease-related, 3 were treatment-related, and 1 was from a second cancer), as did 20 in the chemotherapy group (17 deaths were disease-related, and 3 were treatment-related) (hazard ratio, 0.36; 95% CI, 0.16 to 0.82). The incidence of acute adverse events of grade 4 or higher after prephase treatment was 33.3% in the rituximab-chemotherapy group and 24.2% in the chemotherapy group (P = 0.07); events were related mainly to febrile neutropenia and infection. Approximately twice as many patients in the rituximab-chemotherapy group as in the chemotherapy group had a low IgG level 1 year after trial inclusion.
CONCLUSIONS


Rituximab added to standard LMB chemotherapy markedly prolonged event-free survival and overall survival among children and adolescents with high-grade, high-risk, mature B-cell non-Hodgkin's lymphoma and was associated with a higher incidence of hypogammaglobulinemia and, potentially, more episodes of infection. (Funded by the Clinical Research Hospital Program of the French Ministry of Health and others; ClinicalTrials.gov number, NCT01516580.).",2020,"Approximately twice as many patients in the rituximab-chemotherapy group as in the chemotherapy group had a low IgG level 1 year after trial inclusion.
","['adults with B-cell cancer', ""children with high-grade, mature B-cell non-Hodgkin's lymphoma"", ""328 patients who underwent randomization (164 patients per group); 85.7% of the patients had Burkitt's lymphoma"", ""High-Risk, Mature B-Cell Non-Hodgkin's Lymphoma in Children"", ""patients younger than 18 years of age with high-risk, mature B-cell non-Hodgkin's lymphoma (stage III with an elevated lactate dehydrogenase level or stage IV) or acute leukemia to compare the addition of six doses of rituximab to standard lymphomes malins B ""]","['standard LMB chemotherapy', 'Rituximab', 'LMB) chemotherapy with standard LMB chemotherapy alone', 'rituximab-chemotherapy']","['Event-free survival', 'efficacy and safety', 'incidence of acute adverse events', 'febrile neutropenia and infection', 'prolonged event-free survival and overall survival', 'event-free survival', 'Overall survival and toxic effects']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0079731', 'cui_str': 'B-cell lymphoma (clinical)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0006413', 'cui_str': 'Burkitt lymphoma'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0151754', 'cui_str': '[D]Lactic acid dehydrogenase raised'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",328.0,0.163524,"Approximately twice as many patients in the rituximab-chemotherapy group as in the chemotherapy group had a low IgG level 1 year after trial inclusion.
","[{'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Minard-Colin', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Aupérin', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Pillon', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'G A Amos', 'Initials': 'GAA', 'LastName': 'Burke', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Barkauskas', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Wheatley', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Rafael F', 'Initials': 'RF', 'LastName': 'Delgado', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Alexander', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Uyttebroeck', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Bollard', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'József', 'Initials': 'J', 'LastName': 'Zsiros', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Csoka', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Bernarda', 'Initials': 'B', 'LastName': 'Kazanowska', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Alan K', 'Initials': 'AK', 'LastName': 'Chiang', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Rodney R', 'Initials': 'RR', 'LastName': 'Miles', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wotherspoon', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Adamson', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Vassal', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Patte', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Gross', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1915315']
1660,32416157,Effects of high and low sucrose-containing beverages on blood glucose and hypoglycemic-like symptoms.,"BACKGROUND AND AIMS


There is this intriguing but not yet well-explored suggestion that highly absorbable sucrose-sweetened drinks might exacerbate hunger by promoting temporal hypoglycemia-like responses already in non-diabetic healthy individuals. This might provide a possible additional explanatory mechanism for previous reported associations between consumption of sugar-sweetened drinks and body weight gain. The current study involves two separate and independently conducted human experiments exploring the effects of two different single-doses of sugar-sweetened beverages on temporal blood glucose nadir and possible related behavioral hypoglycemic-like symptoms in healthy participants.
METHODS


By way of two separately conducted between-subjects experiments, effects of 1) a low (29 g) sugar-containing beverage compared to a sweetened zero-energy drink and a milk drink (experiment-1) or 2) a high (80 g) sugar-sweetened beverage compared to a zero-energy and a non-sweetened colored water drink (experiment-2) were measured on changes in blood glucose, behavioral hypoglycemia, appetite and mood.
RESULTS


Experiment-1: The 29 g sucrose containing beverage caused a high (37%) glycemic increase and a smaller response (15%) to the milk drink, which both peaked 30 min after consumption, whereas the sweetened zero-energy drink had very little effect on blood glucose. Regardless of the different magnitude of peak glycemic responses, both the sugar and milk drinks rather equally caused blood glucose concentrations to return to normal and stable baseline values 90 min later. There were no (different) effects of the beverages on behavioral hypoglycemic-like symptoms, appetite or mood. Experiment-2: the 80 g sucrose containing beverage caused a large (72%) glycemic peak response at +30 min after consumption, whereas neither the sweetened zero-energy nor the non-sweetened colored water drink had any meaningful effect on blood glucose. After intake of the 80 g sugar beverage, blood glucose concentrations remained elevated (13%) at +120 min and returned to lower baseline values in the direction of hypoglycemia levels at +165 min. There were no (differential) effects of the beverages on behavioral hypoglycemic symptoms, appetite or mood.
CONCLUSIONS


The current findings indicate that instead of a low (29 g) sugar-containing beverage, a high (80 g) sugar-containing beverage caused blood glucose concentrations to fall below baseline values almost reaching hypoglycemia levels at the end of measurements. There were no hypoglycemic-like behavioral symptoms including changes in appetite or mood: at least not at end of measurements +165 min after consumption. Since this might include that in particular consumption of high-glycemic index drinks could still promote symptoms in the longer run, further research is needed to explore possible hypoglycemic-like effects of high dosages of sugar-sweetened beverages across more extended/delayed time measurements.",2020,There were no hypoglycemic-like behavioral symptoms including changes in appetite or mood: at least not at end of measurements +165min after consumption.,"['healthy participants', 'Experiment-1', 'Experiment-2']","['high and low sucrose-containing beverages', 'low (29g) sugar-containing beverage compared to a sweetened zero-energy drink and a milk drink (experiment-1) or 2) a high (80g) sugar-sweetened beverage compared to a zero-energy and a non-sweetened colored water drink (experiment-2', 'sugar-sweetened beverages']","['blood glucose, behavioral hypoglycemia, appetite and mood', 'behavioral hypoglycemic-like symptoms, appetite or mood', 'blood glucose', 'glycemic peak response', 'blood glucose and hypoglycemic-like symptoms', 'hypoglycemic-like behavioral symptoms including changes in appetite or mood', 'blood glucose concentrations', 'behavioral hypoglycemic symptoms, appetite or mood', 'temporal blood glucose nadir']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C3179078', 'cui_str': 'Energy drink'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0426587', 'cui_str': 'Altered appetite'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}]",,0.0416675,There were no hypoglycemic-like behavioral symptoms including changes in appetite or mood: at least not at end of measurements +165min after consumption.,"[{'ForeName': 'C Rob', 'Initials': 'CR', 'LastName': 'Markus', 'Affiliation': 'University Maastricht, Faculty of Psychology and Neuroscience; Dept of Neuropsychology & Psychopharmacology, Maastricht, Netherlands.. Electronic address: r.markus@maastrichtuniversity.nl.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Rogers', 'Affiliation': 'Nutrition and Behaviour Unit, School of Psychological Science, University of Bristol, Bristol, UK.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.112916']
1661,27198187,Mycoprotein reduces energy intake and postprandial insulin release without altering glucagon-like peptide-1 and peptide tyrosine-tyrosine concentrations in healthy overweight and obese adults: a randomised-controlled trial.,"Dietary mycoprotein decreases energy intake in lean individuals. The effects in overweight individuals are unclear, and the mechanisms remain to be elucidated. This study aimed to investigate the effect of mycoprotein on energy intake, appetite regulation, and the metabolic phenotype in overweight and obese volunteers. In two randomised-controlled trials, fifty-five volunteers (age: 31 (95 % CI 27, 35) years), BMI: 28·0 (95 % CI 27·3, 28·7) kg/m2) consumed a test meal containing low (44 g), medium (88 g) or high (132 g) mycoprotein or isoenergetic chicken meals. Visual analogue scales and blood samples were collected to measure appetite, glucose, insulin, peptide tyrosine-tyrosine (PYY) and glucagon-like peptide-1 (GLP-1). Ad libitum energy intake was assessed after 3 h in part A (n 36). Gastric emptying by the paracetamol method, resting energy expenditure and substrate oxidation were recorded in part B (n 14). Metabonomics was used to compare plasma and urine samples in response to the test meals. Mycoprotein reduced energy intake by 10 % (280 kJ (67 kcal)) compared with chicken at the high content (P=0·009). All mycoprotein meals reduced insulin concentrations compared with chicken (incremental AUClow (IAUClow): -8 %, IAUCmedium: -12 %, IAUChigh: -21 %, P=0·004). There was no significant difference in glucose, PYY, GLP-1, gastric emptying rate and energy expenditure. Following chicken intake, paracetamol-glucuronide was positively associated with fullness. After mycoprotein, creatinine and the deamination product of isoleucine, α-keto-β-methyl-N-valerate, were inversely related to fullness, whereas the ketone body, β-hydroxybutyrate, was positively associated. In conclusion, mycoprotein reduces energy intake and insulin release in overweight volunteers. The mechanism does not involve changes in PYY and GLP-1. The metabonomics analysis may bring new understanding to the appetite regulatory properties of food.",2016,Mycoprotein reduced energy intake by 10 % (280 kJ (67 kcal)) compared with chicken at the high content (P=0·009).,"['overweight volunteers', 'healthy overweight and obese adults', 'overweight and obese volunteers', 'lean individuals', 'fifty-five volunteers (age: 31 (95 % CI 27, 35) years), BMI: 28·0 (95 % CI 27·3, 28·7) kg/m2) consumed a', 'overweight individuals']","['paracetamol-glucuronide', 'test meal containing low (44 g), medium (88 g) or high (132 g) mycoprotein or isoenergetic chicken meals', 'Dietary mycoprotein', 'Mycoprotein', 'mycoprotein']","['Ad libitum energy intake', 'resting energy expenditure and substrate oxidation', 'Gastric emptying', 'Visual analogue scales and blood samples', 'Mycoprotein reduced energy intake', 'glucose, PYY, GLP-1, gastric emptying rate and energy expenditure', 'energy intake', 'appetite, glucose, insulin, peptide tyrosine-tyrosine (PYY) and glucagon-like peptide-1 (GLP-1', 'energy intake and insulin release', 'insulin concentrations']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0050429', 'cui_str': '4-acetamidophenol glucuronide'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2347312', 'cui_str': 'Mycoprotein'}, {'cui': 'C0008051', 'cui_str': 'Gallus gallus domesticus'}]","[{'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0017127', 'cui_str': 'Gastric Emptyings'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C2347312', 'cui_str': 'Mycoprotein'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0070358', 'cui_str': 'PYY Peptide'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0077599', 'cui_str': 'tyrosyltyrosine'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",55.0,0.093901,Mycoprotein reduced energy intake by 10 % (280 kJ (67 kcal)) compared with chicken at the high content (P=0·009).,"[{'ForeName': 'Jeanne H', 'Initials': 'JH', 'LastName': 'Bottin', 'Affiliation': '1Nutrition and Dietetics Research Group,Department of Medicine,Division of Diabetes, Endocrinology and Metabolism,Imperial College London,Hammersmith Campus,London W12 0NN,UK.'}, {'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Swann', 'Affiliation': '2Division of Computational and Systems Medicine,Department of Surgery and Cancer,Imperial College London, South Kensington Campus,London SW7 2AZ,UK.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Cropp', 'Affiliation': '1Nutrition and Dietetics Research Group,Department of Medicine,Division of Diabetes, Endocrinology and Metabolism,Imperial College London,Hammersmith Campus,London W12 0NN,UK.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Chambers', 'Affiliation': '1Nutrition and Dietetics Research Group,Department of Medicine,Division of Diabetes, Endocrinology and Metabolism,Imperial College London,Hammersmith Campus,London W12 0NN,UK.'}, {'ForeName': 'Heather E', 'Initials': 'HE', 'LastName': 'Ford', 'Affiliation': '1Nutrition and Dietetics Research Group,Department of Medicine,Division of Diabetes, Endocrinology and Metabolism,Imperial College London,Hammersmith Campus,London W12 0NN,UK.'}, {'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'Ghatei', 'Affiliation': '3Division of Diabetes, Endocrinology and Metabolism,Department of Medicine,Imperial College London,Hammersmith Campus,London W12 0NN,UK.'}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Frost', 'Affiliation': '1Nutrition and Dietetics Research Group,Department of Medicine,Division of Diabetes, Endocrinology and Metabolism,Imperial College London,Hammersmith Campus,London W12 0NN,UK.'}]",The British journal of nutrition,['10.1017/S0007114516001872']
1662,32416376,Accelerating prostate stereotactic ablative body radiotherapy: Efficacy and toxicity of a randomized phase II study of 11 versus 29 days overall treatment time (PATRIOT).,"BACKGROUND


Prostate stereotactic ablative radiotherapy (SABR) regimens differ in time, dose, and fractionation. We report an update of a multicentre, Canadian randomized phase II study to investigate the impact of overall treatment time on quality of life (QOL), efficacy, and toxicity.
METHODS


Men with intermediate risk prostate cancer were randomized to 40 Gy in 5 fractions delivered every other day (EOD) versus once per week (QW). Primary outcome was proportion of patients experiencing a minimally clinically important change (MCIC) in acute bowel QOL using EPIC. Secondary outcomes were toxicity, biochemical failure (BF), other QOL domains, and the rate of salvage therapy.
FINDINGS


152 men from 3 centers were randomized; the median follow-up was 62 months. Results are described for EOD versus QW. Acute bowel and urinary QOL was reported previously. Late changes in QOL were not significantly different between the two arms. There were 1 (1.3%) vs 3 (2.7%) late grade 3 + GI toxicities (p = 0.36) and 5 (6.7%) vs 2 (2.7%) late grade 3 GU toxicities (p = 0.44). Two and 5 patients had BF (5-year failure rate 3.0 vs 7.2%, p = 0.22); 0 and 4 patients received salvage therapy (p = 0.04). 5-Year OS and CSS was 95.8% and 98.6% with no difference between arms (p = 0.49, p = 0.15). 3 patients in the QW arm developed metastases.
INTERPRETATION


Although we previously reported that weekly prostate SABR had better bowel and urinary QOL compared to EOD, the updated results show no difference in late toxicity, QOL, BF, or PSA kinetics. Patients should be counseled that QW SABR reduces short-term toxicity compared to QW SABR.",2020,Late changes in QOL were not significantly different between the two arms.,"['152 men from 3 centers', 'Men with intermediate risk prostate cancer']","['Accelerating prostate stereotactic ablative body radiotherapy', 'salvage therapy', 'Prostate stereotactic ablative radiotherapy (SABR']","['late toxicity, QOL, BF, or PSA kinetics', 'Late changes in QOL', 'proportion of patients experiencing a minimally clinically important change (MCIC) in acute bowel QOL using EPIC', 'Acute bowel and urinary QOL', 'bowel and urinary QOL', 'metastases', 'BF (5-year failure rate', 'late grade 3 GU toxicities', 'toxicity, biochemical failure (BF), other QOL domains, and the rate of salvage therapy', '5-Year OS and CSS', 'quality of life (QOL), efficacy, and toxicity', 'late grade 3\xa0+\xa0GI toxicities']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C1273342', 'cui_str': 'Epithelial cell count'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0265338', 'cui_str': 'Coffin-Siris syndrome'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",152.0,0.180251,Late changes in QOL were not significantly different between the two arms.,"[{'ForeName': 'Yasir', 'Initials': 'Y', 'LastName': 'Alayed', 'Affiliation': 'Radiation Oncology Unit, Department of Medicine, College of Medicine and College of Medicine Research Center, King Saud University, Saudi Arabia; Oncology Center, King Saud University Medical City, Saudi Arabia; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Harvey', 'Initials': 'H', 'LastName': 'Quon', 'Affiliation': 'Tom Baker Cancer Centre, Calgary, Canada.'}, {'ForeName': 'Aldrich', 'Initials': 'A', 'LastName': 'Ong', 'Affiliation': 'CancerCare Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Cheung', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Chu', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Chung', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Vesprini', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Chowdhury', 'Affiliation': 'CancerCare Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Dilip', 'Initials': 'D', 'LastName': 'Panjwani', 'Affiliation': 'BC Cancer Agency, Abbotsford, Canada.'}, {'ForeName': 'Geordi', 'Initials': 'G', 'LastName': 'Pang', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Korol', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Davidson', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Ananth', 'Initials': 'A', 'LastName': 'Ravi', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Boyd', 'Initials': 'B', 'LastName': 'McCurdy', 'Affiliation': 'CancerCare Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Mamedov', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Deabreu', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Loblaw', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada; Institute of Health Policy Management and Evaluation, University of Toronto, Canada. Electronic address: andrew.loblaw@sunnybrook.ca.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.04.039']
1663,27051616,"Continuous versus bolus tube feeds: Does the modality affect glycemic variability, tube feeding volume, caloric intake, or insulin utilization?","INTRODUCTION


Enteral nutrition (EN) is very important to optimizing outcomes in critical illness. Debate exists regarding the best strategy for enteral tube feeding (TF), with concerns that bolus TF (BTF) may increase glycemic variability (GV) but result in fewer nutritional interruptions than continuous TF (CTF). This study examines if there is a difference in GV, insulin usage, TF volume, and caloric delivery among intensive care patients receiving BTF versus CTF. We hypothesize that there are no significant differences between CTF and BTF when comparing the above parameters.
MATERIALS AND METHODS


Prospective, randomized pilot study of critically ill adult patients undergoing percutaneous endoscopic gastrostomy (PEG) placement for EN was performed between March 1, 2012 and May 15, 2014. Patients were randomized to BTF or CTF. Glucose values, insulin use, TF volume, and calories administered were recorded. Data were organized into 12-h epochs for statistical analyses and GV determination. In addition, time to ≥80% nutritional delivery goal, demographics, Acute Physiology and Chronic Health Evaluation II scores, and TF interruptions were examined. When performing BTF versus CTF assessments, continuous parameters were compared using Mann-Whitney U-test or repeated measures t-test, as appropriate. Categorical data were analyzed using Fisher's exact test.
RESULTS


No significant demographic or physiologic differences between the CTF (n = 24) and BTF (n = 26) groups were seen. The immediate post-PEG 12-h epoch showed significantly lower GV and median TF volume for patients in the CTF group. All subsequent epochs (up to 18 days post-PEG) showed no differences in GV, insulin use, TF volume, or caloric intake. Insulin use for both groups increased when comparing the first 24 h post-PEG values to measurements from day 8. There were no differences in TF interruptions, time to ≥80% nutritional delivery goal, or hypoglycemic episodes.
CONCLUSIONS


This study demonstrated no clinically relevant differences in GV, insulin use, TF volume or caloric intake between BTF and CTF groups. Despite some shortcomings, our data suggest that providers should not feel limited to BTF or CTF because of concerns for GV, time to goal nutrition, insulin use, or caloric intake, and should consider other factors such as resource utilization, ease of administration, and/or institutional/patient characteristics.",2016,The immediate post-PEG 12-h epoch showed significantly lower GV and median TF volume for patients in the CTF group.,"['critically ill adult patients undergoing', 'intensive care patients receiving BTF versus CTF']","['bolus TF (BTF', 'Enteral nutrition (EN', 'CTF', 'Continuous versus bolus tube feeds', 'percutaneous endoscopic gastrostomy (PEG) placement for EN', 'BTF or CTF']","['GV, insulin use, TF volume, or caloric intake', 'GV, insulin use, TF volume or caloric intake', 'time to ≥80% nutritional delivery goal, demographics, Acute Physiology and Chronic Health Evaluation II scores, and TF interruptions', 'GV, insulin usage, TF volume, and caloric delivery', 'GV and median TF volume', 'Glucose values, insulin use, TF volume, and calories', 'TF interruptions, time to ≥80% nutritional delivery goal, or hypoglycemic episodes', 'glycemic variability, tube feeding volume, caloric intake, or insulin utilization', 'glycemic variability (GV']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085559'}]","[{'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0176751', 'cui_str': 'Percutaneous endoscopic gastrostomy (procedure)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]","[{'cui': 'C0240016', 'cui_str': 'Insulin used (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0243028', 'cui_str': 'APACHE II'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0745153', 'cui_str': 'Hypoglycemic attack'}, {'cui': 'C0041281', 'cui_str': 'Tube Feeding'}, {'cui': 'C0042153', 'cui_str': 'use'}]",,0.024551,The immediate post-PEG 12-h epoch showed significantly lower GV and median TF volume for patients in the CTF group.,"[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Evans', 'Affiliation': 'Department of Surgery, Ohio State University College of Medicine, Columbus, Ohio, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Forbes', 'Affiliation': 'Department of Surgery, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'Department of Surgery, Ohio State University College of Medicine, Columbus, Ohio, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Cotterman', 'Affiliation': 'Department of Surgery, Ohio State University College of Medicine, Columbus, Ohio, USA.'}, {'ForeName': 'Chinedu', 'Initials': 'C', 'LastName': 'Njoku', 'Affiliation': 'Department of Surgery, Ohio State University College of Medicine, Columbus, Ohio, USA.'}, {'ForeName': 'Cattleya', 'Initials': 'C', 'LastName': 'Thongrong', 'Affiliation': 'Department of Anesthesiology, Ohio State University College of Medicine, Columbus, Ohio, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tulman', 'Affiliation': 'Department of Anesthesiology, Ohio State University College of Medicine, Columbus, Ohio, USA.'}, {'ForeName': 'Sergio D', 'Initials': 'SD', 'LastName': 'Bergese', 'Affiliation': 'Department of Anesthesiology, Ohio State University College of Medicine, Columbus, Ohio, USA.'}, {'ForeName': 'Sheela', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': 'Department of Clinical Nutrition, Ohio State University College of Medicine, Columbus, Ohio, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Papadimos', 'Affiliation': 'Department of Anesthesiology, Ohio State University College of Medicine, Columbus, Ohio, USA.'}, {'ForeName': 'Stanislaw P', 'Initials': 'SP', 'LastName': 'Stawicki', 'Affiliation': ""Department of Research and Innovation, St. Luke's University Hospital, Bethlehem, Pennsylvania, USA.""}]",International journal of critical illness and injury science,['10.4103/2229-5151.177357']
1664,32416434,The immediate effects of a shoulder brace on muscle activity and scapular kinematics in subjects with shoulder impingement syndrome and rounded shoulder posture: A randomized crossover design.,"BACKGROUND


Round shoulder posture (RSP) is one of the potential risks for shoulder impingement syndrome (SIS) due to alignment deviation of the scapula. Evidence on how the characteristics of a shoulder brace affecting the degree of RSP, shoulder kinematics, and associated muscle activity during movements is limited.
RESEARCH QUESTION


The purposes of this study were (1) to compare the effects of a shoulder brace on clinical RSP measurements, muscle activities and scapular kinematics during arm movements in subjects with shoulder impingement syndrome (SIS) and RSP; and (2) to compare the effects of two configurations (parallel and diagonal) and two tensions (comfortable and forced tension) of the brace straps on muscle activities and scapular kinematics during arm movements in subjects with SIS and RSP.
METHODS


Twenty-four participants (12 males; 12 females) with SIS and RSP were randomly assigned into 2 groups (comfortable then forced, and forced then comfortable) with 2 strap configurations in each tension condition. The pectoralis minor index (PMI), acromial distance (AD) and shoulder angle (SA) were used to assess the degree of RSP. Three-dimensional electromagnetic motion analysis and electromyography were used to record the scapular kinematics and muscle activity during arm movements.
RESULTS


All clinical measurements with the brace were significantly improved (p < 0.05). Under forced tension, muscle activities were higher with the diagonal configuration than with the parallel configuration in the lower trapezius (LT) (1.2-2.3% MVIC, p < 0.05) and serratus anterior (SA) (2.3% MVIC, p = 0.015). For upward rotation and posterior tilting of the scapula, the diagonal configuration was larger than the parallel configuration (1.5°, p = 0.038; 0.4°-0.5°, p < 0.05, respectively).
SIGNIFICANCE


Different characteristics of the straps of the shoulder brace could alter muscle activity and scapular kinematics at different angles during arm movement. Based on the clinical treatment preference, the application of a shoulder brace with a diagonal configuration and forced tension is suggested for SIS and RSP subjects.",2020,All clinical measurements with the brace were significantly improved (p < 0.05).,"['subjects with SIS and RSP.\nMETHODS\n\n\nTwenty-four participants (12 males; 12 females) with SIS and RSP', 'subjects with shoulder impingement syndrome (SIS) and RSP; and (2', 'subjects with shoulder impingement syndrome and rounded shoulder posture']","['Round shoulder posture (RSP', 'shoulder brace', 'two configurations (parallel and diagonal) and two tensions (comfortable and forced tension) of the brace straps']","['pectoralis minor index (PMI), acromial distance (AD) and shoulder angle (SA', 'Under forced tension, muscle activities', 'muscle activity and scapular kinematics', 'clinical RSP measurements, muscle activities and scapular kinematics', 'serratus anterior (SA) ']","[{'cui': 'C0376685', 'cui_str': 'Impingement syndrome of shoulder region'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C0443198', 'cui_str': 'Diagonal'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0183631', 'cui_str': 'Strap'}]","[{'cui': 'C0224347', 'cui_str': 'Pectoralis minor muscle structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0224349', 'cui_str': 'Structure of serratus anterior muscle'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C2717795', 'cui_str': 'Clinical Rounds'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",24.0,0.0621097,All clinical measurements with the brace were significantly improved (p < 0.05).,"[{'ForeName': 'Yuan-Chun', 'Initials': 'YC', 'LastName': 'Chiu', 'Affiliation': 'School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University, Taiwan.'}, {'ForeName': 'Yung-Shen', 'Initials': 'YS', 'LastName': 'Tsai', 'Affiliation': 'Department of Sports Sciences and Institute of Sports Equipment Technology, University of Taipei, Taiwan.'}, {'ForeName': 'Chien-Lung', 'Initials': 'CL', 'LastName': 'Shen', 'Affiliation': 'Department of Products, Taiwan Textile Research Institute, Taiwan.'}, {'ForeName': 'Tyng-Guey', 'Initials': 'TG', 'LastName': 'Wang', 'Affiliation': 'Division of Physical Therapy, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Taiwan.'}, {'ForeName': 'Jing-Lan', 'Initials': 'JL', 'LastName': 'Yang', 'Affiliation': 'Division of Physical Therapy, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Taiwan. Electronic address: yangjinglan@gmail.com.'}, {'ForeName': 'Jiu-Jenq', 'Initials': 'JJ', 'LastName': 'Lin', 'Affiliation': 'School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University, Taiwan; Division of Physical Therapy, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Taiwan. Electronic address: jiujlin@ntu.edu.tw.'}]",Gait & posture,['10.1016/j.gaitpost.2020.04.028']
1665,32417634,"Supplemental selenium and coenzyme Q10 reduce glycation along with cardiovascular mortality in an elderly population with low selenium status - A four-year, prospective, randomised, double-blind placebo-controlled trial.","BACKGROUND


A low intake of selenium has been shown to increase the risk of cardiovascular mortality, and supplementation of selenium and coenzyme Q10 influences this. The mechanism behind is unclear although effects on inflammation, oxidative stress and microRNA expression have been reported. Fructosamine, a marker of long-term glycaemic control, is also a marker of increased risk of heart disease and death, even in non-diabetics.
OBJECTIVE


To analyse the impact of selenium and coenzyme Q10 supplementation on the concentration of fructosamine. Also, the relation between pre-intervention serum selenium concentration and the effect on fructosamine of the intervention was studied.
METHODS


Fructosamine plasma concentration was determined in 219 participants after six and 42 months of intervention with selenium yeast (200 μg/day) and coenzyme Q10 (200 mg/ day) (n = 118 of which 20 had diabetes at inclusion), or placebo (n = 101 of which 18 had diabetes at inclusion). Pre-intervention, the serum selenium levels were 67 μg/L (active treatment group: 66.6 μg/L; placebo group: 67.4 μg/L), corresponding to an estimated intake of 35 μg/day. Changes in concentrations of fructosamine following intervention were assessed by the use of T-tests, repeated measures of variance, and ANCOVA analyses.
RESULTS


Post-intervention selenium concentrations were 210 μg/L in the active group and 72 μg/L in the placebo group. A lower concentration of fructosamine could be seen as a result of the intervention in the total population (P = 0.001) in both the males (P = 0.04) and in the females (P = 0.01) in the non-diabetic population (P = 0.002), and in both the younger (<76 years) (P = 0.01) and the older (≥76 years) participants (P = 0.03). No difference could be demonstrated in fructosamine concentration in the diabetic patients, but the total sample was small (n = 38). In subjects with a low pre-intervention level of serum selenium the intervention gave a more pronounced decrease in fructosamine compared with those with a higher baseline selenium level.
CONCLUSION


A significantly lower concentration of fructosamine was observed in the elderly community-living participants supplemented with selenium and coenzyme Q10 for 42 months compared to those on the placebo. As oxidative mechanisms are involved in the glycation of proteins, less glycoxidation could be a result of the supplementation of selenium and coenzyme Q10, which could have contributed to lower cardiac mortality and less inflammation, as has earlier been reported. This study was registered at Clinicaltrials.gov, and has the identifier NCT01443780.",2020,"In subjects with a low pre-intervention level of serum selenium the intervention gave a more pronounced decrease in fructosamine compared with those with a higher baseline selenium level.
","['219 participants after six and 42 months of intervention with selenium yeast (200\u202fμg/day) and', 'elderly population with low selenium status - A four-year', '\u202f101 of which 18 had diabetes at inclusion']","['Fructosamine', 'selenium and coenzyme Q10', 'coenzyme Q10 ', 'selenium and coenzyme Q10 supplementation', 'placebo (n', 'Supplemental selenium and coenzyme Q10 reduce glycation', 'placebo']","['serum selenium levels', 'fructosamine', 'concentration of fructosamine', 'fructosamine concentration']","[{'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0036025', 'cui_str': 'Saccharomyces cerevisiae'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C0060765', 'cui_str': 'Fructosamine'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]","[{'cui': 'C0455308', 'cui_str': 'Serum selenium measurement'}, {'cui': 'C0060765', 'cui_str': 'Fructosamine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",219.0,0.328184,"In subjects with a low pre-intervention level of serum selenium the intervention gave a more pronounced decrease in fructosamine compared with those with a higher baseline selenium level.
","[{'ForeName': 'Urban', 'Initials': 'U', 'LastName': 'Alehagen', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medical and Health Sciences, Linköping University, SE-581 85 Linköping, Sweden. Electronic address: Urban.Alehagen@liu.se.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Aaseth', 'Affiliation': 'Research Department, Innlandet Hospital Trust, N-2381 Brumunddal, Norway.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Alexander', 'Affiliation': 'Norwegian Institute of Public Health, P.O. Box 222 Skøyen, N-0213 Oslo, Norway.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Johansson', 'Affiliation': 'Department of Social and Welfare studies. Department of Medical and Health Sciences, Linköping University, SE-601 74 Norrköping, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Larsson', 'Affiliation': 'Department of Medical Sciences, Uppsala University, SE-751 85 Uppsala, Sweden.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126541']
1666,31126960,"Results from a Phase IIb, Randomized, Multicenter Study of GVAX Pancreas and CRS-207 Compared with Chemotherapy in Adults with Previously Treated Metastatic Pancreatic Adenocarcinoma (ECLIPSE Study).","PURPOSE


Limited options exist for patients with advanced pancreatic cancer progressing after 1 or more lines of therapy. A phase II study in patients with previously treated metastatic pancreatic cancer showed that combining GVAX pancreas (granulocyte-macrophage colony-stimulating factor-secreting allogeneic pancreatic tumor cells) with cyclophosphamide (Cy) and CRS-207 (live, attenuated  Listeria monocytogenes  expressing mesothelin) resulted in median overall survival (OS) of 6.1 months, which compares favorably with historical OS achieved with chemotherapy. In the current study, we compared Cy/GVAX + CRS-207, CRS-207 alone, and standard chemotherapy in a three-arm, randomized, controlled phase IIb trial.
PATIENTS AND METHODS


Patients with previously treated metastatic pancreatic adenocarcinoma were randomized 1:1:1 to receive Cy/GVAX + CRS-207 (arm A), CRS-207 (arm B), or physician's choice of single-agent chemotherapy (arm C). The primary cohort included patients who had failed ≥2 prior lines of therapy, including gemcitabine. The primary objective compared OS between arms A and C in the primary cohort. The second-line cohort included patients who had received 1 prior line of therapy. Additional objectives included OS between all treatment arms, safety, and tumor responses.
RESULTS


The study did not meet its primary efficacy endpoint. At the final study analysis, median OS [95% confidence interval (CI)] in the primary cohort ( N  = 213) was 3.7 (2.9-5.3), 5.4 (4.2-6.4), and 4.6 (4.2-5.7) months in arms A, B, and C, respectively, showing no significant difference between arm A and arm C [ P  = not significant (NS), HR = 1.17; 95% CI, 0.84-1.64]. The most frequently reported adverse events in all treatment groups were chills, pyrexia, fatigue, and nausea. No treatment-related deaths occurred.
CONCLUSIONS


The combination of Cy/GVAX + CRS-207 did not improve survival over chemotherapy. (ClinicalTrials.gov ID: NCT02004262) See related commentary by Salas-Benito et al., p. 5435 .",2019,"The most frequently reported adverse events in all treatment groups were chills, pyrexia, fatigue, and nausea.","['patients with advanced pancreatic cancer progressing after 1 or more lines of therapy', 'patients who had failed ≥2 prior lines of therapy, including', 'patients who had received 1 prior line of therapy', 'Patients and Methods:  Patients with previously treated metastatic pancreatic adenocarcinoma', 'patients with previously treated metastatic pancreatic cancer', 'Adults with Previously Treated Metastatic Pancreatic Adenocarcinoma (ECLIPSE Study']","['gemcitabine', 'cyclophosphamide (Cy) and CRS-207', 'Chemotherapy', 'GVAX Pancreas and CRS-207', 'Cy/GVAX + CRS-207', 'Cy/GVAX + CRS-207, CRS-207 alone, and standard chemotherapy', ""Cy/GVAX + CRS-207 (arm A), CRS-207 (arm B), or physician's choice of single-agent chemotherapy""]","['survival', 'median overall survival (OS', 'adverse events', 'median OS', 'chills, pyrexia, fatigue, and nausea', 'safety, and tumor responses']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0281361', 'cui_str': 'Adenocarcinoma of pancreas'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]",,0.202644,"The most frequently reported adverse events in all treatment groups were chills, pyrexia, fatigue, and nausea.","[{'ForeName': 'Dung T', 'Initials': 'DT', 'LastName': 'Le', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland. dle@jhmi.edu.'}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Picozzi', 'Affiliation': 'Virginia Mason Medical Center, Seattle, Washington.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Ko', 'Affiliation': 'University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Zev A', 'Initials': 'ZA', 'LastName': 'Wainberg', 'Affiliation': 'University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'Hedy', 'Initials': 'H', 'LastName': 'Kindler', 'Affiliation': 'University of Chicago Medical Center, Chicago, Illinois.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Wang-Gillam', 'Affiliation': 'Washington University School of Medicine in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Oberstein', 'Affiliation': 'Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Morse', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Herbert J', 'Initials': 'HJ', 'LastName': 'Zeh', 'Affiliation': 'University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Weekes', 'Affiliation': 'University of Colorado Cancer Center, Aurora, Colorado.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Reid', 'Affiliation': 'University of San Diego Moores Cancer Center, La Jolla, California.'}, {'ForeName': 'Erkut', 'Initials': 'E', 'LastName': 'Borazanci', 'Affiliation': 'HonorHealth, Tgen, Scottsdale, Arizona.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Crocenzi', 'Affiliation': 'Providence Cancer Center, Portland, Oregon.'}, {'ForeName': 'Noelle K', 'Initials': 'NK', 'LastName': 'LoConte', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, Wisconsin.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Musher', 'Affiliation': 'Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Laheru', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Murphy', 'Affiliation': 'Aduro Biotech, Berkeley, California.'}, {'ForeName': 'Chan', 'Initials': 'C', 'LastName': 'Whiting', 'Affiliation': 'Aduro Biotech, Berkeley, California.'}, {'ForeName': 'Nitya', 'Initials': 'N', 'LastName': 'Nair', 'Affiliation': 'Aduro Biotech, Berkeley, California.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Enstrom', 'Affiliation': 'Aduro Biotech, Berkeley, California.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Ferber', 'Affiliation': 'Array Biostatistics, LLC, Chicago, Illinois.'}, {'ForeName': 'Dirk G', 'Initials': 'DG', 'LastName': 'Brockstedt', 'Affiliation': 'Aduro Biotech, Berkeley, California.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Jaffee', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-18-2992']
1667,32419703,Protocol for a partially nested randomised controlled trial to evaluate the effectiveness of the scleroderma patient-centered intervention network COVID-19 home-isolation activities together (SPIN-CHAT) program to reduce anxiety among at-risk scleroderma patients.,"OBJECTIVE


Contagious disease outbreaks and related restrictions can lead to negative psychological outcomes, particularly in vulnerable populations at risk due to pre-existing medical conditions. No randomised controlled trials (RCTs) have tested interventions to reduce mental health consequences of contagious disease outbreaks. The primary objective of the Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Trial is to evaluate the effect of a videoconference-based program on symptoms of anxiety. Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction.
METHODS


The SPIN-CHAT Trial is a pragmatic RCT that will be conducted using the SPIN-COVID-19 Cohort, a sub-cohort of the SPIN Cohort. Eligible participants will be SPIN-COVID-19 Cohort participants without a positive COVID-19 test, with at least mild anxiety (PROMIS Anxiety 4a v1.0 T-score ≥ 55), not working from home, and not receiving current counselling or psychotherapy. We will randomly assign 162 participants to intervention groups of 7 to 10 participants each or waitlist control. We will use a partially nested RCT design to reflect dependence between individuals in training groups but not in the waitlist control. The SPIN-CHAT Program includes activity engagement, education on strategies to support mental health, and mutual participant support. Intervention participants will receive the 4-week (3 sessions per week) SPIN-CHAT Program via videoconference. The primary outcome is PROMIS Anxiety 4a score immediately post-intervention.
ETHICS AND DISSEMINATION


The SPIN-CHAT Trial will test whether a brief videoconference-based intervention will improve mental health outcomes among at-risk individuals during contagious disease outbreak.",2020,"Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction.
","['Eligible participants will be SPIN-COVID-19 Cohort participants without a positive COVID-19 test, with at least mild anxiety (PROMIS Anxiety 4a v1.0 T-score\u202f≥\u202f55), not working from home, and not receiving current counselling or psychotherapy', '162 participants to intervention groups of 7 to 10 participants each or', 'at-risk scleroderma patients']","['Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities', 'videoconference-based intervention', 'scleroderma patient-centered intervention network COVID-19 home-isolation activities together (SPIN-CHAT) program', 'Together (SPIN-CHAT', 'waitlist control', 'videoconference-based program']","['symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction', 'PROMIS Anxiety 4a score immediately post-intervention', 'mental health outcomes', 'symptoms of anxiety']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0231401', 'cui_str': 'Mild anxiety'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0006019', 'cui_str': 'Boredom'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037420', 'cui_str': 'Interaction with others'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",162.0,0.100017,"Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction.
","[{'ForeName': 'Brett D', 'Initials': 'BD', 'LastName': 'Thombs', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada; Department of Medicine, McGill University, Montreal, Quebec, Canada; Department of Psychology, McGill University, Montreal, Quebec, Canada; Department of Educational and Counselling Psychology, McGill University, Montreal, Quebec, Canada; Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada. Electronic address: brett.thombs@mcgill.ca.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Kwakkenbos', 'Affiliation': 'Department of Clinical Psychology, Behavioural Science Institute, Radboud University, Nijmegen, the Netherlands.'}, {'ForeName': 'Marie-Eve', 'Initials': 'ME', 'LastName': 'Carrier', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Bourgeault', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Tao', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Harb', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Gagarine', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Rice', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychology, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bustamante', 'Affiliation': 'Department of Applied Human Sciences, Concordia University, Montreal, Quebec, Canada.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Ellis', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Delaney', 'Initials': 'D', 'LastName': 'Duchek', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Parash Mani', 'Initials': 'PM', 'LastName': 'Bhandari', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Dipika', 'Initials': 'D', 'LastName': 'Neupane', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Carboni-Jiménez', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Henry', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Ankur', 'Initials': 'A', 'LastName': 'Krishnan', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Levis', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada; Centre for Prognosis Research, School of Primary, Community and Social Care, Keele University, Staffordshire, UK.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'He', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Turner', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Benedetti', 'Affiliation': 'Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada; Department of Medicine, McGill University, Montreal, Quebec, Canada; Respiratory Epidemiology and Clinical Research Unit, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Culos-Reed', 'Affiliation': 'Department of Applied Human Sciences, Concordia University, Montreal, Quebec, Canada; Department of Oncology, Cumming School of Medicine, Calgary, Canada; Department of Psychosocial Resources, Tom Baker Cancer Centre, Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Ghassan', 'Initials': 'G', 'LastName': 'El-Baalbaki', 'Affiliation': 'Department of Psychology, Université du Québec à Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Hebblethwaite', 'Affiliation': 'Department of Applied Human Sciences, Concordia University, Montreal, Quebec, Canada.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Bartlett', 'Affiliation': 'Department of Medicine, McGill University, Montreal, Quebec, Canada; Research Institute, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dyas', 'Affiliation': 'Scleroderma Foundation Michigan Chapter, Southfield, MI, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Patten', 'Affiliation': ""Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada; Hotchkiss Brain Institute and O'Brien Institute for Public Health, University of Calgary, Calgary, Alberta, Canada.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Varga', 'Affiliation': 'Northwestern Scleroderma Program, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110132']
1668,26451734,"Efficacy and Safety of Umeclidinium Added to Fluticasone Propionate/Salmeterol in Patients with COPD: Results of Two Randomized, Double-Blind Studies.","Combinations of drugs with distinct and complementary mechanisms of action may offer improved efficacy in the treatment of chronic obstructive pulmonary disease (COPD). In two 12-week, double-blind, parallel-group studies, patients with COPD were randomized 1:1:1 to once-daily umeclidinium (UMEC; 62.5 μg and 125 μg) or placebo (PBO), added to twice-daily fluticasone propionate/salmeterol (FP/SAL; 250/50 μg). In both studies, the primary efficacy measure was trough forced expiratory volume in 1 second (FEV1) at Day 85. Secondary endpoints were weighted-mean (WM) FEV1 over 0-6 hours post-dose (Day 84) and rescue albuterol use. Health-related quality of life outcomes (St. George's Respiratory Questionnaire [SGRQ] and COPD assessment test [CAT]) were also examined. Safety was assessed throughout. Both UMEC+FP/SAL doses provided statistically significant improvements in trough FEV1 (Day 85: 0.127-0.148 L) versus PBO+FP/SAL. Similarly, both UMEC+FP/SAL doses provided statistically-significant improvements in 0-6 hours post-dose WM FEV1 versus PBO+FP/SAL (Day 84: 0.144-0.165 L). Rescue use over Weeks 1-12 decreased with UMEC+FP/SAL in both studies versus PBO+FP/SAL (Study 1, 0.3 puffs/day [both doses]; Study 2, 0.5 puffs/day [UMEC 125+FP/SAL]). Decreases from baseline in CAT score were generally larger for both doses of UMEC+FP/SAL versus PBO+FP/SAL (except for Day 84 Study 2). In Study 1, no differences in SGRQ score were observed between UMEC+FP/SAL and PBO+FP/SAL; however, in Study 2, statistically significant improvements were observed with UMEC 62.5+FP/SAL (Day 28) and UMEC 125+FP/SAL (Days 28 and 84) versus PBO+FP/SAL. The incidence of on-treatment adverse events across all treatment groups was 37-41% in Study 1 and 36-38% in Study 2. Overall, these data indicate that the combination of UMEC+FP/SAL can provide additional benefits over FP/SAL alone in patients with COPD.",2016,Both UMEC+FP/SAL doses provided statistically significant improvements in trough FEV1 (Day 85: 0.127-0.148 L) versus PBO+FP/SAL.,"['Patients with COPD', 'patients with COPD', 'chronic obstructive pulmonary disease (COPD']","['PBO+FP/SAL', '0.5 puffs/day [UMEC 125+FP/SAL', 'Fluticasone Propionate/Salmeterol', 'UMEC+FP/SAL versus PBO+FP/SAL', 'daily umeclidinium (UMEC; 62.5 μg and 125 μg) or placebo (PBO), added to twice-daily fluticasone propionate/salmeterol (FP/SAL', 'Umeclidinium', 'UMEC+FP/SAL']","['trough forced expiratory volume', 'weighted-mean (WM) FEV1', 'CAT score', ""Health-related quality of life outcomes (St. George's Respiratory Questionnaire [SGRQ] and COPD assessment test [CAT"", 'SGRQ score', 'Efficacy and Safety', 'incidence of on-treatment adverse events', 'trough FEV1', 'Safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}]","[{'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C1533107', 'cui_str': 'Puffs'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C0073992', 'cui_str': 'salmeterol'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3661274', 'cui_str': 'umeclidinium'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}]","[{'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0524517', 'cui_str': 'Felis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.234272,Both UMEC+FP/SAL doses provided statistically significant improvements in trough FEV1 (Day 85: 0.127-0.148 L) versus PBO+FP/SAL.,"[{'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Siler', 'Affiliation': 'a Midwest Chest Consultants, PC, St. Charles , Missouri , USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Kerwin', 'Affiliation': 'b Clinical Research Institute of Southern Oregon , Medford , Oregon , USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Singletary', 'Affiliation': 'c GSK, Respiratory and Immuno-Inflammation, Research Triangle Park , North Carolina , USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Brooks', 'Affiliation': 'd GSK, Respiratory Medicines Development Centre, Stockley Park , Uxbridge , United Kingdom.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Church', 'Affiliation': 'c GSK, Respiratory and Immuno-Inflammation, Research Triangle Park , North Carolina , USA.'}]",COPD,['10.3109/15412555.2015.1034256']
1669,32418856,Effect of topical tranexamic acid on post-traumatic elbow stiffness in patients treated with open arthrolysis: a prospective comparative study.,"BACKGROUND


Elbow joint open arthrolysis is an effective method to release contracted tissue and débride heterotopic ossification in cases of post-traumatic elbow stiffness. Recurrence remains one of the most common concerns for surgeons. Soft tissue contracture may result from intra- and/or extra-articular bleeding, edema, effusion, and granulation. The increasing incidence of intraoperative and postoperative bleeding has caused uncertainty about surgical outcomes. Tranexamic acid (TXA) is effective for reducing surgery-related bleeding and effusions in total hip or knee arthroplasty.
PURPOSE


To investigate whether topical TXA can decrease blood loss and effusions in patients treated with elbow joint open arthrolysis and whether it affects final function.
PATIENTS AND METHOD


A prospective comparative study was conducted. Sixty-one patients with joint stiffness were enrolled and randomly divided into 2 groups: one consisting of 31 patients treated with topical TXA intraoperatively after open arthrolysis (experimental group) and the other consisting of 30 patients who received saline administration (control group). The operation time, tourniquet time, and intraoperative blood loss were recorded. Drainage volume, elbow rotation, elbow motion arc, Mayo Elbow Performance Score, and operation-related complications were followed up and recorded, whereas hematoma volume remaining in the joint space after drainage tube removal was assessed on ultrasonography.
RESULTS


Tourniquet time, intraoperative blood loss, and postoperative drainage were significantly lower in the TXA group than in the control group. However, no significant intergroup differences were found in the incidence of related complications and final function evaluated at the final follow-up.
CONCLUSION


Topical TXA improves surgical quality by controlling intraoperative bleeding, decreases the amount of blood loss soon after surgery, and could become a routine procedure in elbow joint open arthrolysis.",2020,"Tranexamic acid (TXA) is effective for reducing surgery-related bleeding and effusions in total hip or knee arthroplasty.
","['patients treated with elbow joint open arthrolysis', 'Sixty-one patients with joint stiffness', 'patients treated with open arthrolysis']","['TXA', 'topical TXA', 'Topical TXA', 'Tranexamic acid (TXA', 'topical TXA intraoperatively after open arthrolysis (experimental group)\xa0and the other consisting of 30 patients who received saline administration (control group', 'topical tranexamic acid']","['operation time, tourniquet time, and intraoperative blood loss', 'Drainage volume, elbow rotation, elbow motion arc, Mayo Elbow Performance Score, and operation-related complications', 'Tourniquet time, intraoperative blood loss, and postoperative drainage', 'surgical quality', 'post-traumatic elbow stiffness', 'blood loss and effusions', 'incidence of related complications and final function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0013770', 'cui_str': 'Elbow joint structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1283023', 'cui_str': 'Arthrolysis'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0162298', 'cui_str': 'Joint stiffness'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1283023', 'cui_str': 'Arthrolysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0428724', 'cui_str': 'Duration of tourniquet inflation'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0239272', 'cui_str': 'Elbow stiff'}, {'cui': 'C0013687', 'cui_str': 'Effusion'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",61.0,0.0156237,"Tranexamic acid (TXA) is effective for reducing surgery-related bleeding and effusions in total hip or knee arthroplasty.
","[{'ForeName': 'Baokun', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopedic Surgery, Shanghai Jiao Tong University Affiliated No. 6 People's Hospital, Shanghai, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopedic Surgery, Shanghai Jiao Tong University Affiliated No. 6 People's Hospital, Shanghai, China.""}, {'ForeName': 'Jianguang', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Department of Orthopedic Surgery, Shanghai Jiao Tong University Affiliated No. 6 People's Hospital, Shanghai, China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Ding', 'Affiliation': ""Department of Orthopedic Surgery, Shanghai Jiao Tong University Affiliated No. 6 People's Hospital, Shanghai, China. Electronic address: dingjian12187@163.com.""}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2020.02.010']
1670,32417345,Randomized controlled trial to identify the optimal radiotherapy scheme for palliative treatment of incurable head and neck squamous cell carcinoma.,"BACKGROUND


No randomized controlled trials (RCT) have yet identified the optimal palliative radiotherapy scheme in patients with incurable head and neck squamous cell carcinoma (HNSCC). We conducted RCT to compare two radiation schemes in terms of efficacy, toxicity and quality-of-life (QoL).
MATERIALS AND METHODS


Patients with locally-advanced HNSCC who were ineligible for radical treatment and those with limited metastatic disease were randomly assigned in 1:1 ratio to arm 1 (36 Gy in 6 fractions, twice a week) or arm 2 (50 Gy in 16 fractions, four times a week).
RESULTS


The trial was discontinued early because of slow accrual (34 patients enrolled). Objective response rates were 38.9% and 57.1% for arm 1 and 2 respectively (p = 0.476). The median time to loco-regional progression was not reached. The loco-regional control rates at 1 year was 57.4% and 69.3% in arm 1 and 2 (p = 0.450, HR = 0.56, 95%CI 0.12-2.58). One-year overall survival was 33.3% and 57.1%, with medians of 35.4 and 59.5 weeks, respectively (p = 0.215, HR = 0.55, 95%CI 0.21-1.43). Acute grade ≥3 toxicity was lower in arm 1 (16.7% versus 57.1%, p = 0.027), with the largest difference in grade 3 mucositis (5.6% versus 42.9%, p = 0.027). However, no significant deterioration in any of the patient-reported QoL-scales was found.
CONCLUSION


No solid conclusion could be made on this incomplete study which is closed early. Long-course radiotherapy did not show significantly better oncologic outcomes, but was associated with more acute grade 3 mucositis. No meaningful differences in QoL-scores were found. Therefore, the shorter schedule might be carefully advocated. However, this recommendation should be interpreted with great caution because of the inadequate statistical power.",2020,Objective response rates were 38.9% and 57.1% for arm 1 and 2 respectively (p=0.476).,"['patients with incurable head and neck squamous cell carcinoma (HNSCC', 'incurable head and neck squamous cell carcinoma', 'Patients with locally-advanced HNSCC who were ineligible for radical treatment and those with limited metastatic disease']",[],"['grade 3 mucositis', 'QoL-scores', 'efficacy, toxicity and quality-of-life (QoL', 'Acute grade ≥3 toxicity', 'median time to loco-regional progression', 'QoL-scales', 'overall survival', 'loco-regional control rates', 'acute grade 3 mucositis', 'oncologic outcomes', 'Objective response rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",[],"[{'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205478', 'cui_str': 'Oncologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",34.0,0.193028,Objective response rates were 38.9% and 57.1% for arm 1 and 2 respectively (p=0.476).,"[{'ForeName': 'Abrahim', 'Initials': 'A', 'LastName': 'Al-Mamgani', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands. Electronic address: a.almamgani@nki.nl.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Kessels', 'Affiliation': 'Department of Biometrics, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Cornelia G', 'Initials': 'CG', 'LastName': 'Verhoef', 'Affiliation': 'Department of Radiation Oncology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Navran', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Hamming-Vrieze', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Johannes H A M', 'Initials': 'JHAM', 'LastName': 'Kaanders', 'Affiliation': 'Department of Radiation Oncology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Roel J H M', 'Initials': 'RJHM', 'LastName': 'Steenbakkers', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Groningen, University of Groningen, the Netherlands.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tans', 'Affiliation': 'Department of Radiation Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Hoebers', 'Affiliation': 'Department of Radiation Oncology (MAASTRO Clinic), GROW - School for Oncology and Developmental Biology, Maastricht University Medical Center, The Netherlands.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Ong', 'Affiliation': 'Department of Radiation Oncology, Medisch Spectrum Twente, The Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'van Werkhoven', 'Affiliation': 'Department of Biometrics, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Johannes A', 'Initials': 'JA', 'LastName': 'Langendijk', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Groningen, University of Groningen, the Netherlands.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.05.020']
1671,26811126,Drinkers' memory bias for alcohol picture cues in explicit and implicit memory tasks.,"BACKGROUND


Alcohol cues can bias attention and elicit emotional reactions, especially in drinkers. Yet, little is known about how alcohol cues affect explicit and implicit memory processes, and how memory for alcohol cues is affected by acute alcohol intoxication.
METHODS


Young adult participants (N=161) were randomly assigned to alcohol, placebo, or control beverage conditions. Following beverage consumption, they were shown neutral, emotional and alcohol-related pictures cues. Participants then completed free recall and repetition priming tasks to test explicit and implicit memory, respectively, for picture cues. Average blood alcohol concentration for the alcohol group was 74±13mg/dl when memory testing began. Two mixed linear model analyses were conducted to examine the effects of beverage condition, picture cue type, and their interaction on explicit and implicit memory.
RESULTS


Picture cue type and beverage condition each significantly affected explicit recall of picture cues, whereas only picture cue type significantly influenced repetition priming. Individuals in the alcohol condition recalled significantly fewer pictures than those in other conditions, regardless of cue type. Both free recall and repetition priming were greater for emotional and alcohol-related cues compared to neutral picture cues. No interaction effects were detected.
CONCLUSIONS


Young adult drinkers showed enhanced explicit and implicit memory processing of alcohol cues compared to emotionally neutral cues. This enhanced processing for alcohol cues was on par with that seen for positive emotional cues. Acute alcohol intoxication did not alter this preferential memory processing for alcohol cues over neutral cues.",2016,Both free recall and repetition priming were greater for emotional and alcohol-related cues compared to neutral picture cues.,"['Young adult drinkers', 'Young adult participants (N=161']","['alcohol, placebo, or control beverage conditions']","['enhanced explicit and implicit memory processing of alcohol cues', 'explicit recall of picture cues', 'Average blood alcohol concentration']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0561768', 'cui_str': 'Implicit memory (observable entity)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C0684262', 'cui_str': 'Blood Alcohol Level'}]",161.0,0.0200569,Both free recall and repetition priming were greater for emotional and alcohol-related cues compared to neutral picture cues.,"[{'ForeName': 'Tam T', 'Initials': 'TT', 'LastName': 'Nguyen-Louie', 'Affiliation': 'Center of Alcohol Studies, 607 Allison Road, Rutgers University, Piscataway, NJ 08854, United States. Electronic address: ttn045@ucsd.edu.'}, {'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Buckman', 'Affiliation': 'Center of Alcohol Studies, 607 Allison Road, Rutgers University, Piscataway, NJ 08854, United States. Electronic address: jbuckman@rutgers.edu.'}, {'ForeName': 'Suchismita', 'Initials': 'S', 'LastName': 'Ray', 'Affiliation': 'Center of Alcohol Studies, 607 Allison Road, Rutgers University, Piscataway, NJ 08854, United States. Electronic address: shmita@rci.rutgers.edu.'}, {'ForeName': 'Marsha E', 'Initials': 'ME', 'LastName': 'Bates', 'Affiliation': 'Center of Alcohol Studies, 607 Allison Road, Rutgers University, Piscataway, NJ 08854, United States. Electronic address: mebates@rutgers.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2015.12.033']
1672,26614647,Immediate and Complex Cardiovascular Adaptation to an Acute Alcohol Dose.,"BACKGROUND


The detrimental effects of chronic heavy alcohol use on the cardiovascular system are well established and broadly appreciated. Integrated cardiovascular response to an acute dose of alcohol has been less studied. This study examined the early effects of an acute dose of alcohol on the cardiovascular system, with particular emphasis on system variability and sensitivity. The goal was to begin to understand how acute alcohol disrupts dynamic cardiovascular regulatory processes prior to the development of cardiovascular disease.
METHODS


Healthy participants (N = 72, age 21 to 29) were randomly assigned to an alcohol, placebo, or no-alcohol control beverage condition. Beat-to-beat heart rate (HR) and blood pressure (BP) were assessed during a low-demand cognitive task prior to and following beverage consumption. Between-group differences in neurocardiac response to an alcohol challenge (blood alcohol concentration ~ 0.06 mg/dl) were tested.
RESULTS


The alcohol beverage group showed higher average HR, lower average stroke volume, lower HR variability and BP variability, and increased vascular tone baroreflex sensitivity after alcohol consumption. No changes were observed in the placebo group, but the control group showed slightly elevated average HR and BP after beverage consumption, possibly due to juice content. At the level of the individual, an active alcohol dose appeared to disrupt the typically tight coupling between cardiovascular processes.
CONCLUSIONS


A dose of alcohol quickly invoked multiple cardiovascular responses, possibly as an adaptive reaction to the acute pharmacological challenge. Future studies should assess how exposure to alcohol acutely disrupts or dissociates typically integrated neurocardiac functions.",2015,"No changes were observed in the placebo group, but the control group showed slightly elevated average HR and BP after beverage consumption, possibly due to juice content.","['Healthy participants (N\xa0=\xa072, age 21 to 29']","['alcohol', 'placebo', 'alcohol, placebo, or no-alcohol control beverage condition']","['average HR, lower average stroke volume, lower HR variability and BP variability, and increased vascular tone baroreflex sensitivity', 'average HR and BP', 'Beat-to-beat heart rate (HR) and blood pressure (BP', 'neurocardiac response']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0038455', 'cui_str': 'Stroke Volume'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0206162', 'cui_str': 'Reflex, Baroreceptor'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",,0.0345724,"No changes were observed in the placebo group, but the control group showed slightly elevated average HR and BP after beverage consumption, possibly due to juice content.","[{'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Buckman', 'Affiliation': 'Center of Alcohol Studies, Rutgers, The State University of New Jersey, Piscataway, New Jersey.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Eddie', 'Affiliation': 'Center of Alcohol Studies, Rutgers, The State University of New Jersey, Piscataway, New Jersey.'}, {'ForeName': 'Evgeny G', 'Initials': 'EG', 'LastName': 'Vaschillo', 'Affiliation': 'Center of Alcohol Studies, Rutgers, The State University of New Jersey, Piscataway, New Jersey.'}, {'ForeName': 'Bronya', 'Initials': 'B', 'LastName': 'Vaschillo', 'Affiliation': 'Center of Alcohol Studies, Rutgers, The State University of New Jersey, Piscataway, New Jersey.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Garcia', 'Affiliation': 'Center of Alcohol Studies, Rutgers, The State University of New Jersey, Piscataway, New Jersey.'}, {'ForeName': 'Marsha E', 'Initials': 'ME', 'LastName': 'Bates', 'Affiliation': 'Center of Alcohol Studies, Rutgers, The State University of New Jersey, Piscataway, New Jersey.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.12912']
1673,26556240,Willed-movement training reduces brain damage and enhances synaptic plasticity related proteins synthesis after focal ischemia.,"It has been wildly accepted that willed movement(WM) training promotes neurological rehabilitation in patients with stroke. However, it was not clear whether the effect of WM is better than other forms of exercise. The purpose of this study is to assess different effects of WM and other forms of exercise on rats with focal ischemia. The subjects are all had right middle cerebral artery occlusion (MCAO) surgery and randomly allocated to three groups of training and one control group with no training. Infarct volume by 2,3,5-triphenyltetrazolium chloride (TTC) dye, expression of PICK1 and synaptophysin in cerebral cortex and striatum of injured side by western blotting and immunofluorescence performed are analyzed. Exercise has done respectively on rats in each group for 15 days and 30 days. Compared with the control group, the brain damage is reduced in other groups after 15 days exercise. The protein expressions levels of synaptophysin and PICK1 are upregulated after exercise. Concentration of PICK1 protein in WM is greater than other exercise groups, and the expression of synaptophysin in WM and SM groups are higher than EM groups. The number of PICK1 positive cells, synaptophysin and PICK1 co-positive cells are increased by exercise. Synaptophysin is widely distributed in cortex surrounding the injury area in WM and EM. It is indicated in our result that willed-movement training is the most effective intervention in enhancing the PICK1-mediated synaptic plasticity in the area adjacent to the damage region of ischemic rats.",2016,"Concentration of PICK1 protein in WM is greater than other exercise groups, and the expression of synaptophysin in WM and SM groups are higher than EM groups.","['rats with focal ischemia', 'patients with stroke', 'subjects are all had right middle cerebral artery occlusion (MCAO) surgery']","['2,3,5-triphenyltetrazolium chloride (TTC', 'Willed-movement training', 'training and one control group with no training']","['number of PICK1 positive cells, synaptophysin and PICK1 co-positive cells', 'brain damage']","[{'cui': 'C0034721', 'cui_str': 'Rats'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0226213', 'cui_str': 'Structure of right middle cerebral artery'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0146883', 'cui_str': 'triphenyltetrazolium chloride'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0085255', 'cui_str': 'p38 Membrane Protein, Synaptic Vesicle'}, {'cui': 'C0270611', 'cui_str': 'Brain Injuries'}]",,0.0340242,"Concentration of PICK1 protein in WM is greater than other exercise groups, and the expression of synaptophysin in WM and SM groups are higher than EM groups.","[{'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Nie', 'Affiliation': 'Department of Neurology, Xiang Ya hospital, Central South University, Xiang Ya Road 87, 410008 Changsha, Hunan, China.'}, {'ForeName': 'Xiaosu', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, Xiang Ya hospital, Central South University, Xiang Ya Road 87, 410008 Changsha, Hunan, China. Electronic address: sjnk_xy@aliyun.com.'}, {'ForeName': 'Qingping', 'Initials': 'Q', 'LastName': 'Tang', 'Affiliation': 'Department of Neurology, Brain Hospital of Hunan Province, Hunan University of Chinese Medicine, Fu Rong Road 427, Changsha 410007 Hunan, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Shen', 'Affiliation': 'Department of Radiology, The Second Xiangya hospital of Central South University, People Road 139, 410011 Changsha, Hunan, China.'}, {'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of research and education office, XiangYa Stomatological Hospital, Central South University, Xiang Ya Road 72, 410008 Changsha, Hunan, China.'}]",Brain research bulletin,['10.1016/j.brainresbull.2015.11.004']
1674,30772211,"Peripheral refraction and spherical aberration profiles with single vision, bifocal and multifocal soft contact lenses.","PURPOSE


To compare the peripheral refraction and spherical aberration profiles along three visual field meridians of 16 commercial single vision (SV), bifocal (BF) and multifocal (MF) test contact lenses with a single vision control.
METHOD


Forty-four participants [24.2±2.4 years, SE: -0.50 to -4.50D] were randomly fitted, contra-laterally, with 6 SV's [Air Optix Aqua (control), Acuvue Oasys, Biofinity, Clariti, Night & Day and Proclear], 3 BF's [Acuvue Bifocal low and high add, MiSight] and 8 MF's [Proclear D & N in 1.5 and 2.5D adds; AirOptix, PureVision low & high adds]. Peripheral refraction was performed across horizontal, oblique and vertical meridians, with lenses on eye using the BHVI-EyeMapper. The power vectors M, J 0 , J 45  and the spherical aberration coefficient were analysed. The peripheral refraction and aberration profiles of the test lenses were compared with the profiles of the control lens using curvature and slope coefficients.
RESULTS


Compared to the control, a relative peripheral hyperopic shift (M), a less negative J 0  curvature coefficient along the horizontal meridian, a less positive J 0  curvature coefficient along the vertical meridian, a less negative J 45  curvature coefficient along the oblique meridian and a more positive spherical aberration curvature coefficient along most meridians was seen with the Acuvue Bifocal and all center-near multifocal lenses. For the center-distance multifocal lenses the direction of the curvature coefficients of the same refraction and aberration components was opposite to that of the center-near lenses. The greatest differences in the slope coefficients when compared to the control were found for the Acuvue Bifocal lenses and all multifocal contact lenses for the refractive component M and the spherical aberration coefficient along the horizontal visual field meridian, with the Acuvue Bifocal and the center-near multifocal lenses having more positive coefficients and the center-distance lenses having more negative coefficients.
CONCLUSION


When worn on eye, different commercially available lens types produce differences in the direction and magnitude of the peripheral refraction and spherical aberration profiles along different visual field meridians. This information may be relevant to refractive development and myopia control.",2020,"Compared to the control, a relative peripheral hyperopic shift (M), a less negative J 0  curvature coefficient along the horizontal meridian, a less positive J 0  curvature coefficient along the vertical meridian, a less negative J 45  curvature coefficient along the oblique meridian and a more positive spherical aberration curvature coefficient along most meridians was seen with the Acuvue Bifocal and all center-near multifocal lenses.","['Forty-four participants [24.2±2.4 years, SE: -0.50 to -4.50D']","[""6 SV's [Air Optix Aqua (control), Acuvue Oasys, Biofinity, Clariti, Night & Day and Proclear], 3 BF's [Acuvue Bifocal low and high add, MiSight] and 8 MF's [Proclear D & N in 1.5 and 2.5D adds; AirOptix, PureVision low & high adds"", '16 commercial single vision (SV), bifocal (BF) and multifocal (MF) test contact lenses']","['Peripheral refraction', 'peripheral refraction and aberration profiles']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1275647', 'cui_str': 'Bifocals'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0205292', 'cui_str': 'Multifocal (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0009836', 'cui_str': 'Contact Lenses'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0430943', 'cui_str': 'Refraction'}]",,0.0164065,"Compared to the control, a relative peripheral hyperopic shift (M), a less negative J 0  curvature coefficient along the horizontal meridian, a less positive J 0  curvature coefficient along the vertical meridian, a less negative J 45  curvature coefficient along the oblique meridian and a more positive spherical aberration curvature coefficient along most meridians was seen with the Acuvue Bifocal and all center-near multifocal lenses.","[{'ForeName': 'Cathleen', 'Initials': 'C', 'LastName': 'Fedtke', 'Affiliation': 'Brien Holden Vision Institute, Sydney, NSW, Australia; School of Optometry and Vision Sciences, UNSW, Sydney, NSW, Australia.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Ehrmann', 'Affiliation': 'Brien Holden Vision Institute, Sydney, NSW, Australia; School of Optometry and Vision Sciences, UNSW, Sydney, NSW, Australia.'}, {'ForeName': 'Ravi C', 'Initials': 'RC', 'LastName': 'Bakaraju', 'Affiliation': 'Brien Holden Vision Institute, Sydney, NSW, Australia; School of Optometry and Vision Sciences, UNSW, Sydney, NSW, Australia. Electronic address: r.bakaraju@brienholdenvision.org.'}]",Journal of optometry,['10.1016/j.optom.2018.11.002']
1675,32416635,The efficacy and safety of fractional radiofrequency nanoneedle system in the treatment of atrophic acne scars in Asians.,"BACKGROUND


Multiple treatment modalities have been developed to treat atrophic acne scars with varying degrees of success. Post-inflammatory hyperpigmentation (PIH) after acne scar treatments remain a major concern in Asian patients. Fractional radiofrequency (FRF) has been used in many dermatological skin conditions including acne scars.
AIMS


To determine the efficacy and safety of FRF nanoneedle system in the treatment of acne scars in Asians.
METHODS


This is a prospective, evaluator-blinded study with 25 subjects diagnosed with moderate to severe acne scarring. All subjects received 3 monthly treatments of the FRF nanoneedle system on both cheeks. Primary outcome was the clinical improvement of acne scars graded by 2 blinded dermatologists at baseline, 1-, 3-, and 6-month follow-ups. Objective scar volume analysis was done using ultraviolet A (UVA) light video camera. Subjects' self-assessment, pain score, and adverse events were also recorded.
RESULTS


Twenty-three out of 25 subjects completed the study and attended all follow-up. Clinical improvement of acne scars was observed as early as 1-month follow-up. Objective evaluation of acne scar volume decreased significantly on all follow-up compared to baseline (P < .005). Majority of the subjects (48%) reported marked improvement in their acne scars. Adverse events such as pain, erythema, burning sensation, edema, scab formation, and PIH were mild and temporary.
CONCLUSIONS


FRF nanoneedle system is a safe and effective treatment for acne scars in Asians. However, despite the significant changes in the scar volume, caution should be used to avoid excessive coagulation resulting in PIH.",2020,Objective evaluation of acne scar volume decreased significantly on all follow-up compared to baseline (p<0.005).,"['Asian patients', 'acne scars in Asians', '25 subjects diagnosed with moderate to severe acne scarring', 'Twenty-three out of 25 subjects completed the study and attended all follow-up', 'atrophic acne scars in Asians']","['ultraviolet A (UVA) light video camera', 'FRF nanoneedle system', 'fractional radiofrequency nanoneedle system', 'Fractional radiofrequency (FRF']","['clinical improvement of acne scars graded by 2 blinded dermatologists', 'acne scars', 'acne scar volume', ""Subjects' self-assessment, pain score and adverse events"", 'Adverse events such as pain, erythema, burning sensation, edema, scab formation and PIH were mild and temporary', 'efficacy and safety']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0423783', 'cui_str': 'Acne scar'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1274728', 'cui_str': 'Atrophic acne scar'}]","[{'cui': 'C1532472', 'cui_str': 'Ultra-violet'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0179533', 'cui_str': 'Camera'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0423783', 'cui_str': 'Acne scar'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0259831', 'cui_str': 'Dermatologist'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0074125', 'cui_str': 'SCAB protocol'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0333616', 'cui_str': 'Postinflammatory hyperpigmentation'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",25.0,0.0167839,Objective evaluation of acne scar volume decreased significantly on all follow-up compared to baseline (p<0.005).,"[{'ForeName': 'Sunatra', 'Initials': 'S', 'LastName': 'Nitayavardhana', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Rungsima', 'Initials': 'R', 'LastName': 'Wanitphakdeedecha', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Janice Natasha C', 'Initials': 'JNC', 'LastName': 'Ng', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sasima', 'Initials': 'S', 'LastName': 'Eimpunth', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Woraphong', 'Initials': 'W', 'LastName': 'Manuskiatti', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13484']
1676,31822548,Randomised controlled trial comparing hydroxyapatite coated uncemented hemiarthroplasty with cemented hemiarthroplasty for the treatment of displaced intracapsular hip fractures: a protocol for the WHITE 5 study.,"INTRODUCTION


Hip fracture is a serious injury in adults, especially those aged over 60 years. The most common type of hip fracture (displaced intracapsular) is treated for the majority of patients with a partial hip replacement (hemiarthroplasty). The hemiarthroplasty implant can be fixed to the bone with or without bone cement. Cement is the current recommended technique but recently some risks have been identified, which could potentially be avoided by using uncemented implants. Controversy, therefore, remains about which type of hemiarthroplasty offers patients the best outcomes.This is the protocol for a multicentre randomised controlled trial comparing cemented hemiarthroplasty versus uncemented hemiarthroplasty for patients 60 years and over with a displaced intracapsular hip fracture.
METHODS AND ANALYSIS


Multicentre (a minimum of seven UK hospitals), multisurgeon, parallel group, two-arm, superiority, randomised controlled trial. Patients aged 60 years and older with a displaced intracapsular hip fracture treated with hemiarthroplasty surgery are eligible. Participants will be randomly allocated on a 1:1 basis to either a cemented hemiarthroplasty or a modern hydroxyapatite coated uncemented hemiarthroplasty. Otherwise all care will be in accordance with the National Institute for Health and Care Excellence guidance. A minimum of 1128 patients will be recruited to obtain 90% power to detect a 0.075-point difference in the primary endpoint: health-related quality of life (EuroQol 5 dimensions 5 levels) at 4 months postinjury. The treatment effect will be estimated using a two-sided t-test adjusted for age, gender and cognitive impairment based on an intention-to-treat analysis. Secondary outcomes include mortality, complications including revision surgery and cause, mobility status, residential status, health-related quality of life at 1 and 12 months and health resource use. A within-trial economic analysis will be conducted.
ETHICS, DISSEMINATION AND FUNDING


Wales Research Ethics Committee 5 approved the feasibility phase on 2 December 2016 (16/WA/0351) and the definitive trial on 22 November 2017 (17/WA/0383). This study is sponsored by the University of Oxford and funded by the National Institute for Health Research, Research for Patient Benefit (PB-PG-0215-36043 and PB-PG-1216-20021). A manuscript for a peer-reviewed journal will be prepared and the results shared with patients via local mechanisms at participating centres.
TRIAL REGISTRATION NUMBER


ISRCTN18393176.",2019,Patients aged 60 years and older with a displaced intracapsular hip fracture treated with hemiarthroplasty surgery are eligible.,"['adults, especially those aged over 60 years', 'displaced intracapsular hip fractures', 'patients 60 years and over with a displaced intracapsular hip fracture', 'patients with a partial hip replacement (hemiarthroplasty', '1128 patients', 'Patients aged 60 years and older with a displaced intracapsular hip fracture treated with hemiarthroplasty surgery are eligible']","['hydroxyapatite coated uncemented hemiarthroplasty with cemented hemiarthroplasty', 'cemented hemiarthroplasty versus uncemented hemiarthroplasty', 'cemented hemiarthroplasty or a modern hydroxyapatite coated uncemented hemiarthroplasty']","['mortality, complications including revision surgery and cause, mobility status, residential status, health-related quality of life at 1 and 12\u2009months and health resource use']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0392806', 'cui_str': 'Hip Prosthesis Implantation'}, {'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0115137', 'cui_str': 'Durapatite'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0018741', 'cui_str': 'Health Resources'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",1128.0,0.185581,Patients aged 60 years and older with a displaced intracapsular hip fracture treated with hemiarthroplasty surgery are eligible.,"[{'ForeName': 'Miguel Antonio', 'Initials': 'MA', 'LastName': 'Fernandez', 'Affiliation': 'Oxford Trauma, NDORMS, University of Oxford, Oxford, UK.'}, {'ForeName': 'Juul', 'Initials': 'J', 'LastName': 'Achten', 'Affiliation': 'Oxford Trauma, NDORMS, University of Oxford, Oxford, UK.'}, {'ForeName': 'Robin Gillmore', 'Initials': 'RG', 'LastName': 'Lerner', 'Affiliation': 'Oxford Trauma, NDORMS, University of Oxford, Oxford, UK.'}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Mironov', 'Affiliation': 'Oxford Trauma, NDORMS, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Parsons', 'Affiliation': 'Statistics and Epidemiology Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Dritsaki', 'Affiliation': 'Oxford Clinical Trial Unit, NDORMS, University of Oxford, Oxford, UK.'}, {'ForeName': 'May E', 'Initials': 'ME', 'LastName': 'Png', 'Affiliation': 'Oxford Clinical Trial Unit, NDORMS, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alwin', 'Initials': 'A', 'LastName': 'McGibbon', 'Affiliation': 'Patient Representative, London, UK.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Gould', 'Affiliation': 'Patient Representative, London, UK.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Griffin', 'Affiliation': 'Oxford Trauma, NDORMS, University of Oxford, Oxford, UK.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Costa', 'Affiliation': 'Oxford Trauma, NDORMS, University of Oxford, Oxford, UK matthew.costa@ndorms.ox.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2019-033957']
1677,32417382,Randomized open-label trial of intravenous brivaracetam versus lorazepam for acute treatment of increased seizure activity.,"OBJECTIVE


The objective of the present trial was to assess efficacy and safety of intravenous (IV) brivaracetam (BRV) vs. lorazepam (LZP) in patients with epilepsy undergoing evaluation in an epilepsy monitoring unit (EMU) who experienced seizures requiring acute treatment.
METHODS


This was a phase 2, open-label, randomized, active-control, proof-of-concept trial (EP0087; NCT03021018). Patients (18-70 years) admitted to EMU were randomized 1:1:1 to single-dose bolus IV LZP (dose per investigator's practice), IV BRV 100 mg, or IV BRV 200 mg. Trial medication had to be administered within 30 min of qualifying seizure. Primary efficacy outcome was time to next seizure (clinical observation with electroencephalogram [EEG] confirmation) or to rescue medication use within 12 h of trial medication administration. Secondary outcomes included seizure freedom and rescue medication use within 12 h of trial medication administration. Safety and tolerability outcomes included treatment-emergent adverse events (TEAEs).
RESULTS


Overall, 46 patients were randomized, and 45 received trial medication for a qualifying seizure. Patients in the LZP arm had doses from 1 to 4 mg (median: 1 mg). Eleven of 45 patients had a seizure within 12 h of trial medication administration (LZP 5/15 [median time to next seizure: 5.55 h], BRV 100 mg 3/15 [5.97 h], BRV 200 mg 3/15 [3.60 h]). No patients received additional rescue medication to control their qualifying seizure. Most patients were seizure-free over 12 h (LZP 9/15 [60.0%], BRV 100 mg 12/15 [80.0%], BRV 200 mg 12/15 [80.0%]). Rescue medication use within 12 h was numerically higher for LZP (6/15 [40.0%]) vs. BRV 100 mg (1/15 [6.7%]) and vs. BRV 200 mg (2/15 [13.3%]). Treatment-emergent adverse events were reported by 5/16 (31.3%), 6/15 (40.0%), and 3/15 (20.0%) of LZP, BRV 100 mg, and BRV 200 mg patients; one LZP patient had a serious TEAE (seizure cluster). Most common TEAEs (≥10% of patients) were sedation and somnolence with LZP, and dizziness, headache, and nausea with BRV.
SIGNIFICANCE


Intravenous LZP, IV BRV 100 mg, and IV BRV 200 mg showed similar efficacy in controlling acute seizure activity in the EMU. Treatment-emergent adverse events were as expected for each medication. Although this trial should be interpreted with caution because of small patient numbers, it suggests a possible role of BRV in the acute treatment of increased seizure activity.",2020,Rescue medication use within 12 h was numerically higher for LZP (6/15 [40.0%]),"['patients with epilepsy undergoing evaluation in an epilepsy monitoring unit (EMU) who experienced seizures requiring acute treatment', 'Patients (18-70\u202fyears) admitted to EMU', 'Eleven of 45 patients had a seizure within 12\u202fh of trial medication administration ', '46 patients']","['intravenous brivaracetam versus lorazepam', 'intravenous (IV) brivaracetam (BRV) vs. lorazepam (LZP', 'single-dose bolus IV LZP', 'LZP']","['time to next seizure (clinical observation with electroencephalogram [EEG] confirmation) or to rescue medication use within 12\u202fh of trial medication administration', 'acute seizure activity', 'sedation and somnolence with LZP, and dizziness, headache, and nausea with BRV', 'seizure activity', 'seizure-free', 'Safety and tolerability outcomes included treatment-emergent adverse events (TEAEs', 'Treatment-emergent adverse events', 'efficacy and safety', 'seizure freedom and rescue medication use within 12\u202fh of trial medication administration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3469597', 'cui_str': 'Administration of medication'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0024002', 'cui_str': 'Lorazepam'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0521091', 'cui_str': 'Confirmation of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3469597', 'cui_str': 'Administration of medication'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0024002', 'cui_str': 'Lorazepam'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C1299590', 'cui_str': 'Seizure free'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}]",46.0,0.224115,Rescue medication use within 12 h was numerically higher for LZP (6/15 [40.0%]),"[{'ForeName': 'Jerzy P', 'Initials': 'JP', 'LastName': 'Szaflarski', 'Affiliation': 'University of Alabama at Birmingham, Department of Neurology and the UAB Epilepsy Center, 1719 6th Avenue South, CIRC 312, Birmingham, AL 35294, USA. Electronic address: jszaflarski@uabmc.edu.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Sadek', 'Affiliation': 'Neurological Services of Orlando, 3849 Oakwater Cir, Orlando, FL 32806, USA. Electronic address: ahsadek@mac.com.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Greve', 'Affiliation': 'UCB Pharma, Alfred-Nobel-Straße 10, 40789 Monheim am Rhein, Germany. Electronic address: bernhard.greve@ucb.com.'}, {'ForeName': 'Paulette', 'Initials': 'P', 'LastName': 'Williams', 'Affiliation': 'UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: paulette.williams@ucb.com.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Varner', 'Affiliation': 'UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: julie.varner@ucb.com.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Moseley', 'Affiliation': 'University of Cincinnati, 260 Stetson Street, Suite 2300, Cincinnati, OH 45267-0525, USA. Electronic address: briandmoseley@gmail.com.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107127']
1678,29370538,Exploring longitudinal course and treatment-baseline severity interactions in secondary outcomes of smoking cessation treatment in individuals with attention-deficit hyperactivity disorder.,"BACKGROUND


A double blind, placebo-controlled randomized trial (NCT00253747) evaluating osmotic-release oral system methylphenidate (OROS-MPH) for smoking-cessation revealed a significant interaction effect in which participants with higher baseline ADHD severity had better abstinence outcomes with OROS-MPH while participants with lower baseline ADHD severity had worse outcomes.
OBJECTIVES


This current report examines secondary outcomes that might bear on the mechanism for this differential treatment effect.
METHODS


Longitudinal analyses were conducted to evaluate the effect of OROS-MPH on three secondary outcomes (ADHD symptom severity, nicotine craving, and withdrawal) in the total sample (N = 255, 56% Male), and in the high (N = 134) and low (N = 121) baseline ADHD severity groups.
RESULTS


OROS-MPH significantly improved ADHD symptoms and nicotine withdrawal symptoms in the total sample, and exploratory analyses showed that in both higher and lower baseline severity groups, OROS-MPH statistically significantly improved these two outcomes. No effect on craving overall was detected, though exploratory analyses showed statistically significantly decreased craving in the high ADHD severity participants on OROS-MPH. No treatment by ADHD baseline severity interaction was detected for the outcomes.
CONCLUSIONS


Methylphenidate improved secondary outcomes during smoking cessation independent of baseline ADHD severity, with no evident treatment-baseline severity interaction. Our results suggest divergent responses to smoking cessation treatment in the higher and lower severity groups cannot be explained by concordant divergence in craving, withdrawal and ADHD symptom severity, and alternative hypotheses may need to be identified.",2018,"No effect on craving overall was detected, though exploratory analyses showed statistically significantly decreased craving in the high ADHD severity participants on OROS-MPH.","['255, 56% Male), and in the high (N\xa0=\xa0134) and low (N\xa0=\xa0121) baseline ADHD severity groups', 'individuals with attention-deficit hyperactivity disorder']","['placebo', 'OROS-MPH', 'smoking cessation treatment', 'methylphenidate (OROS-MPH', 'Methylphenidate']","['ADHD symptom severity, nicotine craving, and withdrawal', 'craving overall', 'OROS-MPH', 'ADHD baseline severity interaction', 'craving', 'ADHD symptoms and nicotine withdrawal symptoms']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}]","[{'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0872355', 'cui_str': 'Nicotine craving'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0028047', 'cui_str': 'Nicotine withdrawal (disorder)'}]",,0.129435,"No effect on craving overall was detected, though exploratory analyses showed statistically significantly decreased craving in the high ADHD severity participants on OROS-MPH.","[{'ForeName': 'Sean X', 'Initials': 'SX', 'LastName': 'Luo', 'Affiliation': 'a Department of Psychiatry , Columbia University , New York , NY, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Wall', 'Affiliation': 'a Department of Psychiatry , Columbia University , New York , NY, USA.'}, {'ForeName': 'Lirio', 'Initials': 'L', 'LastName': 'Covey', 'Affiliation': 'a Department of Psychiatry , Columbia University , New York , NY, USA.'}, {'ForeName': 'Mei-Chen', 'Initials': 'MC', 'LastName': 'Hu', 'Affiliation': 'a Department of Psychiatry , Columbia University , New York , NY, USA.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Scodes', 'Affiliation': 'a Department of Psychiatry , Columbia University , New York , NY, USA.'}, {'ForeName': 'Frances R', 'Initials': 'FR', 'LastName': 'Levin', 'Affiliation': 'a Department of Psychiatry , Columbia University , New York , NY, USA.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'a Department of Psychiatry , Columbia University , New York , NY, USA.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': 'b Department of Psychiatry , University of Cincinnati , Cincinnati , OH, USA.'}]",The American journal of drug and alcohol abuse,['10.1080/00952990.2017.1416474']
1679,32417537,Dual X-ray absorptiometry has limited utility in detecting bone pathology in children with hypophosphatasia: A pooled post hoc analysis of asfotase alfa clinical trial data.,"Asfotase alfa is an enzyme replacement therapy approved for treatment of patients with pediatric-onset hypophosphatasia (HPP), a rare, inherited, systemic disease causing impaired skeletal mineralization, short stature, and reduced physical function in children. The role of dual X-ray absorptiometry (DXA) in the assessment of children with HPP has been insufficiently explored. This post hoc analysis included pooled DXA data from 2 open-label, multicenter studies in 19 children with HPP. The study population was aged ≥5 to <18 years and had received asfotase alfa for ≤6.6 years at enrollment (male: 79%; median age at enrollment: 10.4 y [range: 5.9-16.7]; treatment duration: 6.3 y [range: 0.1-6.6]. Baseline height Z-scores indicated short stature (median [min, max]: -1.26 [-6.6, 0]); mean [SD]: -2.30 [1.97]), thus requiring height adjustment of DXA Z-scores. At Baseline, few patients had height-adjusted bone mineral density (BMD ht ) Z-scores of -2 or less for whole body (n = 3) or lumbar spine (n = 5). In treated patients, mean whole body and lumbar spine BMD ht Z-scores did not change over time, but whole body and lumbar spine height- adjusted bone mineral content (BMC ht ) Z-scores increased significantly from Baseline to Last Assessment (P ≤ 0.0056). Improvements in Radiographic Global Impression of Change (RGI-C) scale scores correlated significantly with increases in whole body and lumbar spine BMC ht Z-scores (P < 0.05) but not BMD ht Z-Scores. Improvements in Rickets Severity Score (RSS) correlated significantly with increases in lumbar spine BMD ht Z-scores and whole body BMC ht  Z-scores (P < 0.05). No significant correlations were observed between any DXA and bone histomorphometry measure. These findings suggest that DXA BMD Z-scores, which are commonly used in clinical practice, have limited utility in assessing deficient bone mineralization in patients with HPP. Although BMC ht Z-scores increased significantly over time with asfotase alfa therapy, the lack of significant changes in more than one DXA parameter suggests that this tool may not be useful in everyday clinical practice. Furthermore, the use of BMC as an independent metric is not typical or recommended by guidelines. Complementary measures, such as skeletal radiographs supplemented with age-appropriate functional assessments, should be considered.",2020,Improvements in Radiographic Global Impression of Change (RGIC) scale scores correlated significantly with increases in whole body and lumbar spine BMC ht Z-scores (P < 0.05) but not BMD ht  Z-Scores.,"['patients with pediatric-onset hypophosphatasia (HPP', 'children with hypophosphatasia', 'The study population was aged ≥5 to <18\u202fyears and had received asfotase alfa for ≤6.6\u202fyears at enrollment (male: 79%; median age at enrollment: 10.4 y [range: 5.9-16.7];]; treatment duration: 6.3 y [range: 0.1-6.6', '19 children with HPP', 'patients with HPP', 'children with HPP']","['dual X-ray absorptiometry (DXA', 'Dual X-ray absorptiometry']","['BMC ht  Z-scores', 'whole body and lumbar spine height- adjusted bone mineral content (BMC ht ) Z-scores', 'mean [SD', 'Rickets Severity Score (RSS', 'mean whole body and lumbar spine BMD ht Z-scores', 'Radiographic Global Impression of Change (RGIC) scale scores', 'DXA and bone histomorphometry measure', 'lumbar spine BMD ht Z-scores and whole body', 'height-adjusted bone mineral density (BMD ht ) Z-scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0020630', 'cui_str': 'Hypophosphatasia'}, {'cui': 'C0520739', 'cui_str': 'Hereditary pyropoikilocytosis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3490795', 'cui_str': 'asfotase alfa'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C5191376', 'cui_str': '10.4'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517590', 'cui_str': '16.7'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C4517823', 'cui_str': '6.6'}]","[{'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}]","[{'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0035579', 'cui_str': 'Rickets'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0175693', 'cui_str': 'Russell-Silver syndrome'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0200771', 'cui_str': 'Bone histomorphometry'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",19.0,0.0447297,Improvements in Radiographic Global Impression of Change (RGIC) scale scores correlated significantly with increases in whole body and lumbar spine BMC ht Z-scores (P < 0.05) but not BMD ht  Z-Scores.,"[{'ForeName': 'Jill H', 'Initials': 'JH', 'LastName': 'Simmons', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Vanderbilt University, Village at Vanderbilt, 1500 21st Ave South, Suite 1514, Nashville, TN 37212, USA. Electronic address: jill.h.simmons@vumc.org.'}, {'ForeName': 'Eric T', 'Initials': 'ET', 'LastName': 'Rush', 'Affiliation': ""Department of Pediatrics, Children's Mercy Kansas City, Adele Hall Campus, 2401 Gillham Rd, Kansas City, MO 64108, USA; University of Missouri - Kansas City School of Medicine, 2411 Holmes St, Kansas City, MO 64108, USA; University of Kansas School of Medicine, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: etrush@cmh.edu.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Petryk', 'Affiliation': 'Alexion Pharmaceuticals, Inc., 121 Seaport Blvd., Boston, MA 02210, USA. Electronic address: Anna.Petryk@alexion.com.'}, {'ForeName': 'Shanggen', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Clinical Development Services-Corporate, Covance, Inc., 210 Carnegie Center, Princeton, NJ 08540, USA. Electronic address: shanggen.zhou@covance.com.'}, {'ForeName': 'Gabriel Á', 'Initials': 'GÁ', 'LastName': 'Martos-Moreno', 'Affiliation': 'Department of Endocrinology, Hospital Infantil Universitario Niño Jesús, IIS La Princesa, Av. de Menéndez Pelayo, 65, 28009 Madrid, Spain; Department of Pediatrics, Universidad Autónoma de Madrid, Calle Arzobispo Morcillo, 4, 28029 Madrid, Spain; CIBERobn, Instituto de Salud Carlos III, C/ Sinesio Delgado, 4, 28029 Madrid, Spain. Electronic address: gabrielangelmartos@yahoo.es.'}]",Bone,['10.1016/j.bone.2020.115413']
1680,31545681,"Effect of Transdermal Testosterone and Oral Progesterone on Drug-Induced QT Interval Lengthening in Older Men: A Randomized, Double-Blind, Placebo-Controlled Crossover-Design Study.",,2019,,['Older Men'],"['Placebo', 'Transdermal Testosterone and Oral Progesterone']",[],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}]",[],,0.332368,,"[{'ForeName': 'Elena Tomaselli', 'Initials': 'ET', 'LastName': 'Muensterman', 'Affiliation': 'College of Pharmacy, Purdue University, Indianapolis, IN (E.T.M., H.A.J., K.M.S., B.R.O., J.E.T.).'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Jaynes', 'Affiliation': 'College of Pharmacy, Purdue University, Indianapolis, IN (E.T.M., H.A.J., K.M.S., B.R.O., J.E.T.).'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Sowinski', 'Affiliation': 'College of Pharmacy, Purdue University, Indianapolis, IN (E.T.M., H.A.J., K.M.S., B.R.O., J.E.T.).'}, {'ForeName': 'Brian R', 'Initials': 'BR', 'LastName': 'Overholser', 'Affiliation': 'College of Pharmacy, Purdue University, Indianapolis, IN (E.T.M., H.A.J., K.M.S., B.R.O., J.E.T.).'}, {'ForeName': 'Changyu', 'Initials': 'C', 'LastName': 'Shen', 'Affiliation': 'Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (C.S.).'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Kovacs', 'Affiliation': 'Krannert Institute of Cardiology (R.J.K.), School of Medicine, Indiana University, Indianapolis.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Tisdale', 'Affiliation': 'College of Pharmacy, Purdue University, Indianapolis, IN (E.T.M., H.A.J., K.M.S., B.R.O., J.E.T.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.041395']
1681,30612514,Design of randomized controlled confirmatory trials using historical control data to augment sample size for concurrent controls.,"This paper deals with the methods to augment concurrent controls (CC) in a randomized controlled trial with available historical data in clinical studies. In their article,  Matching with multiple control groups and adjusting for group differences , Stuart and Rubin proposed a matching method where the primary/local control and the secondary/non-local control are both included in the propensity score estimates. The authors discuss a similar approach taking the CC as the primary and the historical control as the secondary, and find that this approach does not save the sample size of the randomized trial compared to the traditional randomized design without supplementation of historical data. A new matching method that saves sample size is proposed, where propensity scores are estimated without the concurrent randomized control patients. A two-stage design is proposed, which allows one to examine the assumption of the new matching method before a commitment of using the matching method in the second stage. Previous clinical trials data is used as an example to illustrate the feasibility of the proposed methods. Simulation studies have been used to investigate operating characteristics of the proposed method.",2019,"A two-stage design is proposed, which allows one to examine the assumption of the new matching method before a commitment of using the matching method in the second stage.",[],[],[],[],[],[],,0.0923274,"A two-stage design is proposed, which allows one to examine the assumption of the new matching method before a commitment of using the matching method in the second stage.","[{'ForeName': 'Jiacheng', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': 'a Biostatistics , Allergan Inc , Irvine , CA , USA.'}, {'ForeName': 'Jeen', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'a Biostatistics , Allergan Inc , Irvine , CA , USA.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Zhu', 'Affiliation': 'a Biostatistics , Allergan Inc , Irvine , CA , USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'b Department of Biomedical Data Science , Stanford University School of Medicine , Stanford , CA , USA.'}, {'ForeName': 'Ulo', 'Initials': 'U', 'LastName': 'Palm', 'Affiliation': 'c Drug Development Operations , Allergan Inc , Madison , NJ , USA.'}]",Journal of biopharmaceutical statistics,['10.1080/10543406.2018.1559853']
1682,31537473,"Radiation-induced cystitis treated with hyperbaric oxygen therapy (RICH-ART): a randomised, controlled, phase 2-3 trial.","BACKGROUND


Late radiation cystitis is an adverse effect of cancer treatment with radiotherapy in the pelvic region. Symptoms of late radiation cystitis can be assessed with the Expanded Prostate Index Composite Score (EPIC). Previous reports indicate that hyperbaric oxygen therapy reduces symptoms from late radiation cystitis, but the evidence is predominantly based on non-randomised and retrospective studies. We aimed to assess whether hyperbaric oxygen therapy would mitigate symptoms of late radiation cystitis.
METHODS


We did a randomised, controlled, phase 2-3 trial (RICH-ART [Radiation Induced Cystitis treated with Hyperbaric oxygen-A Randomised controlled Trial]) at five Nordic university hospitals. All patients aged 18-80 years, with pelvic radiotherapy completed at least 6 months previously, a score of less than 80 in the urinary domain of the Expanded Prostate Index Composite Score (EPIC), and referred to participating hyperbaric clinics due to symptoms of late radiation cystitis, were eligible for inclusion. Exclusion criteria were ongoing bleeding requiring blood transfusion exceeding 500 mL in the past 4 weeks, permanent urinary catheter, bladder capacity less than 100 mL, fistula in the urinary bladder, previous treatment with hyperbaric oxygen therapy for late radiation injuries, and contraindications to hyperbaric oxygen therapy. After computer-generated 1:1 randomisation with block sizes of four for each stratification group (sex, time from radiotherapy to inclusion, and previous invasive surgery in the pelvic area), patients received hyperbaric oxygen therapy (30-40 sessions, 100% oxygen, breathed at a pressure of 240-250 kPa, for 80-90 min daily) or standard care with no restrictions for other medications or interventions. No masking was applied. The primary outcome was change in patient-perceived urinary symptoms assessed with EPIC from inclusion to follow-up at visit 4 (6-8 months later), measured as absolute change in EPIC urinary total score. RICH-ART closed enrolment on Dec 31, 2017; the last follow-up data will be compiled in 2023. RICH-ART is registered with ClinicalTrials.gov, number NCT01659723, and with the European Medicines Agency, number EudraCT 2012-001381-15.
FINDINGS


Of 223 patients screened between May 9, 2012, and Dec 20, 2017, 87 patients were enrolled and randomly assigned to either hyperbaric oxygen therapy (n=42) or standard care (n=45). After excluding eight patients who withdrew consent directly after randomisation (one in the hyperbaric oxygen therapy group and seven in the standard care group), 79 were included in the intention-to-treat analyses (n=41 in the hyperbaric oxygen therapy group, n=38 in the standard care group). Median time from randomisation to visit 4 was 234 days (IQR 210-262) in the hyperbaric oxygen therapy group and 217 days (195-237) in the standard care group. The difference between change in group mean of EPIC urinary total score at visit 4 was 10·1 points (95% CI 2·2-18·1; p=0·013; 17·8 points [SD 18·4] in the hyperbaric oxygen therapy group vs 7·7 points [15·5] in the standard care group). 17 (41%) of 41 patients in the hyperbaric oxygen therapy group experienced transient grade 1-2 adverse events, related to sight and hearing, during the period of hyperbaric oxygen therapy.
INTERPRETATION


Our results suggest that hyperbaric oxygen therapy relieves symptoms of late radiation cystitis. We conclude that hyperbaric oxygen therapy is a safe and well tolerated treatment.
FUNDING


The regional research fund of Region Västra Götaland, Sweden, the regional Health Technology Assessment Centre at Sahlgrenska University Hospital, Sweden, and Lions Cancer Research Fund of Western Sweden.",2019,"17 (41%) of 41 patients in the hyperbaric oxygen therapy group experienced transient grade 1-2 adverse events, related to sight and hearing, during the period of hyperbaric oxygen therapy.
","['n=42) or standard care (n=45', 'group and seven in the standard care group), 79 were included in the intention-to-treat analyses (n=41 in the hyperbaric oxygen therapy group, n=38 in the standard care group', 'All patients aged 18-80 years, with pelvic radiotherapy completed at least 6 months previously, a score of less than 80 in the urinary domain of the Expanded Prostate Index Composite Score (EPIC), and referred to participating hyperbaric clinics due to symptoms of late radiation cystitis, were eligible for inclusion', '223 patients screened between May 9, 2012, and Dec 20, 2017, 87 patients', 'five Nordic university hospitals']","['hyperbaric oxygen therapy', 'hyperbaric oxygen therapy (30-40 sessions, 100% oxygen, breathed at a pressure of 240-250 kPa, for 80-90 min daily) or standard care with no restrictions for other medications or interventions', 'Radiation-induced cystitis treated with hyperbaric oxygen therapy (RICH-ART', 'RICH-ART [Radiation Induced Cystitis treated with Hyperbaric oxygen', 'radiotherapy']","['symptoms of late radiation cystitis', 'Symptoms of late radiation cystitis', 'Expanded Prostate Index Composite Score (EPIC', 'Median time', 'transient grade 1-2 adverse events, related to sight and hearing', 'change in patient-perceived urinary symptoms assessed with EPIC', 'EPIC urinary total score', 'absolute change in EPIC urinary total score']","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric Oxygen Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0436385', 'cui_str': 'Radiotherapy completed'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0156270', 'cui_str': 'Irradiation cystitis (disorder)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C0020431', 'cui_str': 'Hyperbaric Oxygen Therapy'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439474', 'cui_str': 'kPa'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0156270', 'cui_str': 'Irradiation cystitis (disorder)'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}]",79.0,0.156227,"17 (41%) of 41 patients in the hyperbaric oxygen therapy group experienced transient grade 1-2 adverse events, related to sight and hearing, during the period of hyperbaric oxygen therapy.
","[{'ForeName': 'Nicklas', 'Initials': 'N', 'LastName': 'Oscarsson', 'Affiliation': 'Angereds Närsjukhus, Angered, Sweden; Department of Anaesthesiology and Intensive Care, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden. Electronic address: nicklas.oscarsson@vgregion.se.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Müller', 'Affiliation': 'Hyperbaric Medicine Unit, Department of Occupational Medicine, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Rosén', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Pär', 'Initials': 'P', 'LastName': 'Lodding', 'Affiliation': 'Department of Urology, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Mölne', 'Affiliation': 'Department of Pathology and Genetics, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Giglio', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Karin M', 'Initials': 'KM', 'LastName': 'Hjelle', 'Affiliation': 'Department of Urology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Guro', 'Initials': 'G', 'LastName': 'Vaagbø', 'Affiliation': 'Hyperbaric Medicine Unit, Department of Occupational Medicine, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Hyldegaard', 'Affiliation': 'Department of Anaesthesia and Surgery, Hyperbaric Unit, University Hospital of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Vangedal', 'Affiliation': 'Department of Urology, Herlev-Gentofte University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Salling', 'Affiliation': 'Department of Urology, University Hospital of Copenhagen, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Kjellberg', 'Affiliation': 'Perioperative Medicine and Intensive Care, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Folke', 'Initials': 'F', 'LastName': 'Lind', 'Affiliation': 'Department of Physiology and Pharmacology, Section for Anaesthesiology and Intensive Care Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Ettala', 'Affiliation': 'Department of Urology, University of Turku, Turku, Finland.'}, {'ForeName': 'Olli', 'Initials': 'O', 'LastName': 'Arola', 'Affiliation': 'Department of Anaesthesiology and Intensive, University of Turku, Turku, Finland.'}, {'ForeName': 'Helén', 'Initials': 'H', 'LastName': 'Seeman-Lodding', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30494-2']
1683,32048386,Optimal drug administration manner would rescue partial virological response in chronic hepatitis B patients with entecavir or tenofovir treatment.,"Not all treatment-naïve patients receiving entecavir (ETV) or tenofovir disoproxil fumarate (TDF) therapy can achieve complete virological response, and many factors may be related with the outcome of partial virological response. This study aimed to determine whether the manner of drug administration affects the antiviral efficacy of ETV/TDF monotherapy. All eligible patients were divided into complete or partial response cohorts based on their virological response following 24-week therapy. Factors related with partial response were evaluated. Patients with partial response were further grouped depending on whether they later adjusted the manner of drug administration, and the antiviral efficacy was compared between the two groups during prolonged treatment. A total of 518 patients were enrolled. Suboptimal drug administration (OR 77.511, P = .000), positive-HBeAg (OR 3.191, P = .000) and ETV treatment (OR 2.537, P = .001) were identified as independent risk factors for partial response. Among patients with partial response, 213 were in the adjusted group and 76 were in the unadjusted group. The percentages of patients with undetectable serum HBV DNA (78.9% vs 31.6%, P < .001) and with normal alanine aminotransferase (ALT) (88.7% vs 68.4%, P < .001) were both higher in the adjusted group than that in unadjusted group following a further 6-month therapy. In conclusion, the manner of drug administration is an important factor influencing the efficacy of ETV/TDF therapy, and optimal drug administration manner can help to increase antiviral efficacy and rescue patients with partial response.",2020,"The percentages of patients with undetectable serum HBV DNA (78.9% vs 31.6%, p <0.001) and with normal ALT (88.7% vs 68.4%, p <0.001) were both higher in the adjusted group than that in unadjusted group following a further 6-months therapy.","['Patients with partial response', 'chronic hepatitis B patients with entecavir or tenofovir treatment', 'patients with partial response, 213 were in the adjusted group and 76 were in the unadjusted group', '518 patients were enrolled']","['ETV/TDF monotherapy', 'entecavir (ETV) or tenofovir disoproxil fumarate (TDF) therapy']","['antiviral efficacy', 'undetectable serum HBV DNA', 'positive-HBeAg', 'rescue partial virological response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0524909', 'cui_str': 'Chronic Hepatitis B Virus Infection'}, {'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1874329', 'cui_str': 'Antivirals, topical'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0019167', 'cui_str': 'e Antigens'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0205466', 'cui_str': 'virology'}]",518.0,0.0291061,"The percentages of patients with undetectable serum HBV DNA (78.9% vs 31.6%, p <0.001) and with normal ALT (88.7% vs 68.4%, p <0.001) were both higher in the adjusted group than that in unadjusted group following a further 6-months therapy.","[{'ForeName': 'Ya-Chao', 'Initials': 'YC', 'LastName': 'Tao', 'Affiliation': 'Center of Infectious Diseases, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Meng-Lan', 'Initials': 'ML', 'LastName': 'Wang', 'Affiliation': 'Center of Infectious Diseases, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Dong-Mei', 'Initials': 'DM', 'LastName': 'Zhang', 'Affiliation': 'Center of Infectious Diseases, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Dong-Bo', 'Initials': 'DB', 'LastName': 'Wu', 'Affiliation': 'Center of Infectious Diseases, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yong-Hong', 'Initials': 'YH', 'LastName': 'Wang', 'Affiliation': 'Center of Infectious Diseases, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Center of Infectious Diseases, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': 'Center of Infectious Diseases, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'En-Qiang', 'Initials': 'EQ', 'LastName': 'Chen', 'Affiliation': 'Center of Infectious Diseases, West China Hospital, Sichuan University, Chengdu, China.'}]",Journal of viral hepatitis,['10.1111/jvh.13275']
1684,31299658,Education Program Regarding Labor Epidurals Increases Utilization by Hispanic Medicaid Beneficiaries: A Randomized Controlled Trial.,"BACKGROUND


Hispanic women choose epidural labor analgesia less commonly than non-Hispanic women. This may represent a healthcare disparity related to a language barrier and inadequate opportunities for labor analgesia education. It was hypothesized that a language-concordant, educational program regarding labor epidurals would improve epidural utilization in two independent cohorts of Hispanic and non-Hispanic women.
METHODS


A randomized controlled trial, blinded to anesthesia, nursing, and obstetric providers, was completed at an academic hospital (February 2015 to February 2017). Two cohorts of Medicaid beneficiaries of Hispanic (English- and/or Spanish-speaking) and non-Hispanic ethnicity were enrolled concurrently. The patients were randomized to routine care alone or routine care and an additional educational program comprised of three components: a video show, corresponding pamphlet, and in-person counseling. The primary endpoint was use of epidural labor analgesia. The secondary endpoint was change in response before and after delivery on common misconceptions based on a 12-point epidural questionnaire.
RESULTS


Hispanic women randomized to the intervention group were 33% more likely to choose epidural analgesia compared to the routine care group (40 of 50 [80%] vs. 30 of 50 [60%]; risk ratio, 1.33 [95% CI, 1.02 to 1.74]; P = 0.029). For the non-Hispanic cohort, no difference was detected in epidural use between the intervention and routine care groups (41 of 50 [82%] vs. 42 of 49 [86%]; risk ratio, 0.96 [95% CI, 0.80 to 1.14]; P = 0.62), but the study was underpowered to determine a result of no difference. Patients assigned to the intervention had a greater improvement in epidural understanding compared with routine care, among both Hispanic (2.26 vs. 0.74, respectively; difference in change from baseline, 1.52 [95% CI, 0.77 to 2.27]; P < 0.001) and non-Hispanic (1.36 vs. 0.33, respectively; difference in change from baseline, 1.03 [95% CI, 0.23 to 1.75]; P = 0.005) cohorts. There were no adverse events during the trial.
CONCLUSIONS


The educational program increased epidural use among Hispanic women. The educational program reduced misconceptions regarding epidural analgesia in both Hispanic and non-Hispanic cohorts.",2019,"RESULTS


Hispanic women randomized to the intervention group were 33% more likely to choose epidural analgesia compared to the routine care group (40 of 50 [80%] vs. 30 of 50 [60%]; risk ratio, 1.33 [95% CI, 1.02 to 1.74]; P = 0.029).","['TOPIC\n\n\nHispanic women choose epidural labor analgesia less commonly than non-Hispanic women', 'Hispanic women choose epidural labor analgesia less commonly than non-Hispanic women', 'Hispanic Medicaid Beneficiaries', 'Hispanic women', 'Two cohorts of Medicaid beneficiaries of Hispanic (English- and/or Spanish-speaking) and non-Hispanic ethnicity', 'Hispanic but not non-Hispanic women', 'anesthesia, nursing, and obstetric providers, was completed at an academic hospital (February 2015 to February 2017']","['routine care alone or routine care and an additional educational program comprised of three components: a video show, corresponding pamphlet, and in-person counseling', 'Education Program', 'educational program']","['epidural understanding', 'epidural analgesia', 'adverse events', '12-point epidural questionnaire', 'epidural labor analgesia', 'epidural utilization']","[{'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}]","[{'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0002769', 'cui_str': 'Analgesia, Epidural'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0042153', 'cui_str': 'use'}]",,0.158021,"RESULTS


Hispanic women randomized to the intervention group were 33% more likely to choose epidural analgesia compared to the routine care group (40 of 50 [80%] vs. 30 of 50 [60%]; risk ratio, 1.33 [95% CI, 1.02 to 1.74]; P = 0.029).","[{'ForeName': 'Brandon M', 'Initials': 'BM', 'LastName': 'Togioka', 'Affiliation': 'From the Department of Anesthesiology and Perioperative Medicine, Oregon Health and Science University, Portland, Oregon (B.M.T., L.M.N., M.M.T.) the Department of Anesthesiology and Critical Care Medicine, University of New Mexico, Albuquerque, New Mexico (K.M.S.) the Memorial Hospital (Beacon Health System), South Bend, Indiana (M.K.W.) the School of Public Health, Oregon Health and Science University and Portland State University, Portland Oregon (N.D.Y., M.M.T.).'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Seligman', 'Affiliation': ''}, {'ForeName': 'Megan K', 'Initials': 'MK', 'LastName': 'Werntz', 'Affiliation': ''}, {'ForeName': 'N David', 'Initials': 'ND', 'LastName': 'Yanez', 'Affiliation': ''}, {'ForeName': 'Lorna M', 'Initials': 'LM', 'LastName': 'Noles', 'Affiliation': ''}, {'ForeName': 'Miriam M', 'Initials': 'MM', 'LastName': 'Treggiari', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000002868']
1685,26951940,Improved clinical outcome and biomarkers in adults with papulopustular rosacea treated with doxycycline modified-release capsules in a randomized trial.,"BACKGROUND


Patients with rosacea have increased amounts of cathelicidin and protease activity but their usefulness as disease biomarkers is unclear.
OBJECTIVE


We sought to evaluate the effect of doxycycline treatment on cathelicidin expression, protease activity, and clinical response in rosacea.
METHODS


In all, 170 adults with papulopustular rosacea were treated for 12 weeks with doxycycline 40-mg modified-release capsules or placebo in a multicenter, randomized, double-blind, placebo-controlled study. Clinical response was compared with cathelicidin and protease activity in stratum corneum samples obtained by tape strip and in skin biopsy specimens obtained from a random subset of patients.
RESULTS


Treatment with doxycycline significantly reduced inflammatory lesions and improved investigator global assessment scores compared with placebo. Cathelicidin expression and protein levels decreased over the course of 12 weeks in patients treated with doxycycline. Low levels of protease activity and cathelicidin expression at 12 weeks correlated with treatment success. Low protease activity at baseline was a predictor of clinical response in the doxycycline treatment group.
LIMITATIONS


Healthy control subjects were not studied.
CONCLUSIONS


Improved clinical outcome correlated with reduced cathelicidin and protease activity, supporting both the mechanism of doxycycline and the potential of these molecules as biomarkers for rosacea.",2016,"RESULTS


Treatment with doxycycline significantly reduced inflammatory lesions and improved investigator global assessment scores compared with placebo.","['Healthy control subjects', 'adults with papulopustular rosacea treated with', 'Patients with rosacea', '170 adults with papulopustular rosacea', 'rosacea']","['doxycycline modified-release capsules', 'doxycycline 40-mg modified-release capsules or placebo', 'placebo', 'doxycycline']","['Low levels of protease activity and cathelicidin expression', 'investigator global assessment scores', 'cathelicidin expression, protease activity, and clinical response', 'inflammatory lesions', 'Cathelicidin expression and protein levels', 'Low protease activity']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1449853', 'cui_str': 'Papulopustular Rosacea'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035854', 'cui_str': 'Rosacea'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}]","[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C4544813', 'cui_str': 'Modified-release'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030940', 'cui_str': 'Peptide Hydrolases'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0671062', 'cui_str': 'cathelicidin'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3872830', 'cui_str': 'Inflammatory lesion'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}]",170.0,0.415438,"RESULTS


Treatment with doxycycline significantly reduced inflammatory lesions and improved investigator global assessment scores compared with placebo.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Di Nardo', 'Affiliation': 'Department of Dermatology, University of California-San Diego, School of Medicine, La Jolla, California. Electronic address: adinardo@ucsd.edu.'}, {'ForeName': 'Anna D', 'Initials': 'AD', 'LastName': 'Holmes', 'Affiliation': 'Galderma Laboratories LP, Fort Worth, Texas.'}, {'ForeName': 'Yumiko', 'Initials': 'Y', 'LastName': 'Muto', 'Affiliation': 'Department of Dermatology, University of California-San Diego, School of Medicine, La Jolla, California.'}, {'ForeName': 'Eugene Y', 'Initials': 'EY', 'LastName': 'Huang', 'Affiliation': 'Therapeutics Clinical Research, San Diego, California; Department of Veterans Affairs San Diego Healthcare System, San Diego, California.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Preston', 'Affiliation': 'Galderma Laboratories LP, Fort Worth, Texas.'}, {'ForeName': 'Warren J', 'Initials': 'WJ', 'LastName': 'Winkelman', 'Affiliation': 'Galderma Laboratories LP, Fort Worth, Texas.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Gallo', 'Affiliation': 'Department of Dermatology, University of California-San Diego, School of Medicine, La Jolla, California.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2016.01.023']
1686,31509182,Cerebral differences between dopamine-resistant and dopamine-responsive Parkinson's tremor.,"Rest tremor in Parkinson's disease is related to cerebral activity in both the basal ganglia and a cerebello-thalamo-cortical circuit. Clinically, there is strong interindividual variation in the therapeutic response of tremor to dopaminergic medication. This observation casts doubt on the idea that Parkinson's tremor has a dopaminergic basis. An interesting alternative explanation is that interindividual differences in the pathophysiology of tremor may underlie this clinical heterogeneity. Previous work showed that dopaminergic medication reduces Parkinson's tremor by inhibiting tremulous activity in the pallidum and thalamus, and this may explain why some tremors are dopamine-responsive. Here we test the hypothesis that dopamine-resistant resting tremor may be explained by increased contributions of non-dopaminergic brain regions, such as the cerebellum. To test this hypothesis, we first performed a levodopa challenge test in 83 tremulous Parkinson's disease patients, and selected 20 patients with a markedly dopamine-responsive tremor (71% reduction) and 14 patients with a markedly dopamine-resistant tremor (6% reduction). The dopamine response of other core motor symptoms was matched between groups. Next, in all 34 patients, we used combined EMG-functional MRI to quantify tremor-related brain activity during two separate sessions (crossover, double-blind, counterbalanced design): after placebo, or after 200/50 mg dispersible levodopa/benserazide. We compared tremor-related brain activity between groups and medication sessions. Both groups showed tremor amplitude-related brain activity in a cerebello-thalamo-cortical circuit. Dopamine-resistant tremor patients showed increased tremor-related activity in non-dopaminergic areas (cerebellum), whereas the dopamine-responsive group showed increased tremor-related activity in the thalamus and secondary somatosensory cortex (across medication sessions). Levodopa inhibited tremor-related thalamic responses in both groups, but this effect was significantly greater in dopamine-responsive patients. These results suggest that dopamine-resistant tremor may be explained by increased cerebellar and reduced somatosensory influences onto the cerebellar thalamus, making this region less susceptible to the inhibitory effects of dopamine.",2019,"Previous work showed that dopaminergic medication reduces Parkinson's tremor by inhibiting tremulous activity in the pallidum and thalamus, and this may explain why some tremors are dopamine-responsive.","[""83 tremulous Parkinson's disease patients, and selected 20 patients with a markedly dopamine-responsive tremor (71% reduction) and 14 patients with a markedly dopamine-resistant tremor (6% reduction""]","['placebo, or after 200/50 mg dispersible levodopa/benserazide']","['tremor amplitude-related brain activity', 'tremor-related activity', 'Levodopa inhibited tremor-related thalamic responses']","[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0005014', 'cui_str': 'Benserazide'}]","[{'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}]",,0.0176348,"Previous work showed that dopaminergic medication reduces Parkinson's tremor by inhibiting tremulous activity in the pallidum and thalamus, and this may explain why some tremors are dopamine-responsive.","[{'ForeName': 'Michiel F', 'Initials': 'MF', 'LastName': 'Dirkx', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Centre for Cognitive Neuroimaging, Radboud University Nijmegen, HB Nijmegen, The Netherlands.'}, {'ForeName': 'Heidemarie', 'Initials': 'H', 'LastName': 'Zach', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Centre for Cognitive Neuroimaging, Radboud University Nijmegen, HB Nijmegen, The Netherlands.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'van Nuland', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Centre for Cognitive Neuroimaging, Radboud University Nijmegen, HB Nijmegen, The Netherlands.'}, {'ForeName': 'Bastiaan R', 'Initials': 'BR', 'LastName': 'Bloem', 'Affiliation': 'Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, HB Nijmegen, The Netherlands.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Toni', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Centre for Cognitive Neuroimaging, Radboud University Nijmegen, HB Nijmegen, The Netherlands.'}, {'ForeName': 'Rick C', 'Initials': 'RC', 'LastName': 'Helmich', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Centre for Cognitive Neuroimaging, Radboud University Nijmegen, HB Nijmegen, The Netherlands.'}]",Brain : a journal of neurology,['10.1093/brain/awz261']
1687,30907298,"Variations in grief, anxiety, depression, and health among family caregivers before and after the death of a close person in the context of palliative home care.","This article investigates longitudinal variations in grief, self-rated health, and symptoms of anxiety and depression among family caregivers in palliative care. Data were taken from a randomized psycho-educational intervention trial and were collected at four time-points; at baseline, upon completion, 2 months later, and 6 months after the patient's death. In total, 117 family caregivers completed all questionnaires. The participants' grief was stable across the measurements, while anxiety, depression, and health varied significantly ( p  < 0.05). No significant differences were found between the intervention or control group. In conclusion, grief emerged as a constant phenomenon, distinct from symptoms of anxiety and depression.",2020,No significant differences were found between the intervention or control group.,"['family caregivers in palliative care', '117 family caregivers completed all questionnaires']",[],"['anxiety, depression, and health', 'grief, anxiety, depression, and health among family caregivers']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018235', 'cui_str': 'Grief'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}]",117.0,0.0390778,No significant differences were found between the intervention or control group.,"[{'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Holm', 'Affiliation': 'Department of Nursing Sciences, Sophiahemmet University, Stockholm, Sweden.'}, {'ForeName': 'Kristofer', 'Initials': 'K', 'LastName': 'Årestedt', 'Affiliation': 'Faculty of Health and Life Sciences, Linnaeus University, Kalmar, Sweden.'}, {'ForeName': 'Joakim', 'Initials': 'J', 'LastName': 'Öhlen', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Alvariza', 'Affiliation': 'Department of Health Care Sciences, Ersta Sköndal Bräcke University College, Stockholm, Sweden.'}]",Death studies,['10.1080/07481187.2019.1586797']
1688,32419119,The Effectiveness and Cost-effectiveness of a Parenting Intervention Integrated with Primary Health Care on Early Childhood Development: a Cluster-Randomized Controlled Trial.,"Developing countries require interventions that can sustainably improve early childhood development (ECD) at scale because hundreds of millions of children are at risk of poor development. This study examined the effectiveness and cost-effectiveness of a parenting intervention integrated with primary health care in terms of ECD. A cluster-randomized controlled trial was conducted in 20 urban communities in China, with 82 and 86 children aged 1-2 months enrolled in the intervention and control groups, respectively, and 71 and 69 children, respectively, followed to 14 months of age. All children in both groups received routine primary health care services. Intervention caregivers received a parenting pamphlet and two parenting training sessions during well-child clinic visits; those with children with suspected developmental delay received additional parenting guidance by telephone. Compared with controls, children receiving the intervention had similar developmental outcomes, measured with the Chinese version of the Ages & Stages Questionnaires third edition (ASQ-C), at baseline, but had significantly higher communication (adjusted mean difference = 0.26; 95% CI 0.03, 0.51), fine motor (adjusted mean difference = 0.19; 95% CI 0.01, 0.37), and overall (adjusted mean difference = 0.25; 95% CI 0.10, 0.41) ASQ-C z-scores after 12 months of the intervention. The intervention cost per child was $50.87, and the costs for increasing the communication, fine motor, and overall ASQ-C scores by one SD were $195.65, $267.74, and $203.48, respectively. Our findings indicate that the integration of a parenting intervention with existing primary health care is a cost-effective way to improve ECD.",2020,"Compared with controls, children receiving the intervention had similar developmental outcomes, measured with the Chinese version of the Ages & Stages Questionnaires third edition (ASQ-C), at baseline, but had significantly higher communication (adjusted mean difference = 0.26; 95% CI 0.03, 0.51), fine motor (adjusted mean difference = 0.19; 95% CI 0.01, 0.37), and overall (adjusted mean difference = 0.25; 95% CI 0.10, 0.41) ASQ-C z-scores after 12 months of the intervention.","['20 urban communities in China, with 82 and 86 children aged 1-2\xa0months enrolled in the intervention and control groups, respectively, and 71 and 69 children, respectively, followed to 14\xa0months of age']","['parenting pamphlet and two parenting training sessions during well-child clinic visits; those with children with suspected developmental delay received additional parenting guidance by telephone', 'routine primary health care services', 'Parenting Intervention Integrated with Primary Health Care', 'parenting intervention integrated with primary health care']","['costs for increasing the communication, fine motor, and overall ASQ-C scores', 'Chinese version of the Ages & Stages Questionnaires third edition (ASQ-C', 'fine motor', 'effectiveness and cost-effectiveness', 'Effectiveness and Cost-effectiveness']","[{'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0424605', 'cui_str': 'Developmental delay'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0441796', 'cui_str': 'Third edition'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.116487,"Compared with controls, children receiving the intervention had similar developmental outcomes, measured with the Chinese version of the Ages & Stages Questionnaires third edition (ASQ-C), at baseline, but had significantly higher communication (adjusted mean difference = 0.26; 95% CI 0.03, 0.51), fine motor (adjusted mean difference = 0.19; 95% CI 0.01, 0.37), and overall (adjusted mean difference = 0.25; 95% CI 0.10, 0.41) ASQ-C z-scores after 12 months of the intervention.","[{'ForeName': 'Huifeng', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing, 38 Xueyuan Road, Haidian District, Beijing, 100191, China.'}, {'ForeName': 'Xuejun', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, 168 Litang Road, Changping District, Beijing, 102218, China. lixuejun0627@163.com.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Fang', 'Affiliation': 'China Center for Health Development Studies (CCHDS), Peking University, 38 Xueyuan Road, Haidian District, Beijing, 100191, China.'}, {'ForeName': 'Jingxu', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing, 38 Xueyuan Road, Haidian District, Beijing, 100191, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing, 38 Xueyuan Road, Haidian District, Beijing, 100191, China. xlwang@bjmu.edu.cn.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01126-2']
1689,26177486,"Effects of Cinnamon, Cardamom, Saffron, and Ginger Consumption on Markers of Glycemic Control, Lipid Profile, Oxidative Stress, and Inflammation in Type 2 Diabetes Patients.","OBJECTIVES


Type 2 diabetes (T2D) may be caused by elevated oxidative stress, inflammation, and hyperglycemia. The phytochemicals in several herbal medicines are reported to effectively improve diabetes and to ameliorate diabetic complications. The aim of the present study was to determine the effects of cinnamon, cardamom, saffron, and ginger as supplementary remedies in T2D.
METHODS


This randomized controlled, clinical trial included 204 T2D patients. The participants were randomly assigned to four intervention groups receiving 3 glasses of black tea and either 3 g cardamom, or cinnamon, or ginger, or 1 g saffron and one control group which consumed only 3 tea glasses without any herbal medicine for 8 weeks. Markers of inflammation, oxidative stress, fasting blood sugar, lipid profile, and anthropometric measures were evaluated at baseline and after 8 weeks of intervention.
RESULTS


After 8 weeks of intervention, cinnamon, cardamom, ginger, and saffron consumption had significant effects on total cholesterol, LDL, and HDL levels (p < 0.05) compared with controls. However, the herbal products did not have significant effects on measures of glycemic control, anthropometry, inflammation, and oxidative stress. In within-group comparisons only, cinnamon intake significantly decreased fasting blood sugar (FBS).
CONCLUSIONS


The herbal remedies examined had significantly beneficial effects on cholesterol, but not on measures of glycemic control, oxidative stress, and inflammation. Based on the contradictory results reported in the literature, the effects of herbal medicine in diabetic patients should undergo further detailed investigation.",2014,"The herbal remedies examined had significantly beneficial effects on cholesterol, but not on measures of glycemic control, oxidative stress, and inflammation.","['Type 2 Diabetes Patients', 'diabetic patients', '204 T2D patients']","['intervention groups receiving 3 glasses of black tea and either 3 g cardamom, or cinnamon, or ginger, or 1 g saffron and one control group which consumed only 3 tea glasses without any herbal medicine', 'herbal medicine', 'Cinnamon, Cardamom, Saffron, and Ginger Consumption', 'cinnamon, cardamom, saffron, and ginger']","['glycemic control, anthropometry, inflammation, and oxidative stress', 'Markers of Glycemic Control, Lipid Profile, Oxidative Stress, and Inflammation', 'total cholesterol, LDL, and HDL levels', 'Markers of inflammation, oxidative stress, fasting blood sugar, lipid profile, and anthropometric measures', 'glycemic control, oxidative stress, and inflammation', 'fasting blood sugar (FBS']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0017596', 'cui_str': 'Glass'}, {'cui': 'C0452440', 'cui_str': 'Black Tea'}, {'cui': 'C0453247', 'cui_str': 'Cardamom'}, {'cui': 'C1112857', 'cui_str': 'Cinnamon'}, {'cui': 'C1879327', 'cui_str': 'Zingiber officinale'}, {'cui': 'C2348128', 'cui_str': 'Saffron'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C2240391', 'cui_str': 'Herbal medicine (product)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",204.0,0.0426926,"The herbal remedies examined had significantly beneficial effects on cholesterol, but not on measures of glycemic control, oxidative stress, and inflammation.","[{'ForeName': 'Paria', 'Initials': 'P', 'LastName': 'Azimi', 'Affiliation': 'Food Security Research Center, Isfahan University of Medical Science, Isfahan, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Ghiasvand', 'Affiliation': 'Food Security Research Center, Isfahan University of Medical Science, Isfahan, Iran.'}, {'ForeName': 'Awat', 'Initials': 'A', 'LastName': 'Feizi', 'Affiliation': 'Food Security Research Center, Isfahan University of Medical Science, Isfahan, Iran.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Hariri', 'Affiliation': 'Food Security Research Center, Isfahan University of Medical Science, Isfahan, Iran.'}, {'ForeName': 'Behnoud', 'Initials': 'B', 'LastName': 'Abbasi', 'Affiliation': 'Food Security Research Center, Isfahan University of Medical Science, Isfahan, Iran.'}]",The review of diabetic studies : RDS,['10.1900/RDS.2014.11.258']
1690,26157651,Ultra fast-track extubation in heart transplant surgery patients.,"BACKGROUND


Heart transplant surgeries using cardiopulmonary bypass (CPB) typically requires mechanical ventilation in intensive care units (ICU) in post-operation period. Ultra fast-track extubation (UFE) have been described in patients undergoing various cardiac surgeries.
AIM


To determine the possibility of ultra-fast-track extubation instead of late extubation in post heart transplant patients.
MATERIALS AND METHODS


Patients randomly assigned into two groups; Ultra fast-track extubation (UFE) group was defined by extubation inside operating room right after surgery. Late extubation group was defined by patients who were not extubated in operating room and transferred to post operation cardiac care unit (CCU) to extubate.
RESULTS


The mean cardiopulmonary bypass time was 136.8 ± 25.7 minutes in ultra-fast extubation and 145.3 ± 29.8 minutes in late extubation patients (P > 0.05). Mechanical ventilation duration (days) was 0 days in ultra-fast and 2.31 ± 1.8 days in late extubation. Length of ICU stay was significantly higher in late extubation group (4.2 ± 1.2 days) than the UFE group (1.72 ± 1.5 days) (P = 0.02). In survival analysis there was no significant difference between ultra-fast and late extubation groups (Log-rank test, P = 0.9).
CONCLUSIONS


Patients undergoing cardiac transplant could be managed with ""ultra-fast-track extubation"", without increased morbidity and mortality.",2015,"In survival analysis there was no significant difference between ultra-fast and late extubation groups (Log-rank test, P = 0.9).
","['heart transplant surgery patients', 'post heart transplant patients', 'Patients randomly assigned into two groups', 'patients undergoing various cardiac surgeries', 'Patients undergoing cardiac transplant']","['cardiopulmonary bypass (CPB', 'UFE', 'Ultra fast-track extubation', 'Ultra fast-track extubation (UFE', 'ultra-fast-track extubation']","['Length of ICU stay', 'morbidity and mortality', 'mean cardiopulmonary bypass time', 'Mechanical ventilation duration']","[{'cui': 'C0018823', 'cui_str': 'Transplantation, Cardiac'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}]","[{'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}]","[{'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0429123', 'cui_str': 'Cardiopulmonary bypass time (observable entity)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",,0.0504425,"In survival analysis there was no significant difference between ultra-fast and late extubation groups (Log-rank test, P = 0.9).
","[{'ForeName': 'Amir Abbas', 'Initials': 'AA', 'LastName': 'Kianfar', 'Affiliation': 'Lung Transplantation Research Center, National Research of Tuberculosis and Lung Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zargham Hossein', 'Initials': 'ZH', 'LastName': 'Ahmadi', 'Affiliation': 'Lung Transplantation Research Center, National Research of Tuberculosis and Lung Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Mohsen', 'Initials': 'SM', 'LastName': 'Mirhossein', 'Affiliation': 'Lung Transplantation Research Center, National Research of Tuberculosis and Lung Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Jamaati', 'Affiliation': 'Tobacco Prevention and Control Research Center, National Research Institute of Tuberculosis and Lung Diseases, Tehran, Iran.'}, {'ForeName': 'Babak Sharif', 'Initials': 'BS', 'LastName': 'Kashani', 'Affiliation': 'Tobacco Prevention and Control Research Center, National Research Institute of Tuberculosis and Lung Diseases, Tehran, Iran.'}, {'ForeName': 'Seyed Amir', 'Initials': 'SA', 'LastName': 'Mohajerani', 'Affiliation': 'Chronic Respiratory Disease Research Center, National Research Institute of Tuberculosis and Lung Disease, Tehran, Iran.'}, {'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Firoozi', 'Affiliation': 'Lung Transplantation Research Center, National Research of Tuberculosis and Lung Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farshid', 'Initials': 'F', 'LastName': 'Salehi', 'Affiliation': 'Lung Transplantation Research Center, National Research of Tuberculosis and Lung Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Golnar', 'Initials': 'G', 'LastName': 'Radmand', 'Affiliation': 'Chronic Respiratory Disease Research Center, National Research Institute of Tuberculosis and Lung Disease, Tehran, Iran.'}, {'ForeName': 'Seyed Mohammadreza', 'Initials': 'SM', 'LastName': 'Hashemian', 'Affiliation': 'Chronic Respiratory Disease Research Center, National Research Institute of Tuberculosis and Lung Disease, Tehran, Iran.'}]",International journal of critical illness and injury science,['10.4103/2229-5151.158394']
1691,31827320,"Pharmacokinetics and Safety of Esketamine in Chinese Patients Undergoing Painless Gastroscopy in Comparison with Ketamine: A Randomized, Open-Label Clinical Study.","Purpose


To assess the pharmacokinetics and safety of pure S-ketamine (esketamine) in Chinese patients undergoing painless gastroscopy and evaluate the potential advantage of esketamine in clinical treatment compared with racemate ketamine hydrochloride injection.
Patients and methods


A randomized, open-label, parallel-controlled, Phase I study was performed with 32 patients undergoing painless gastroscopy. Patients received a single dose of esketamine (0.5 mg/kg) or racemic ketamine (1 mg/kg, esketamine:R-ketamine=1:1), injected in 10 s. Blood samples were collected for pharmacokinetic analysis. The concentrations of esketamine, R-ketamine, S-norketamine, and R-norketamine were measured with a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) method.
Results


After administering a single dose of esketamine and racemate ketamine, the pharmacokinetics parameters of esketamine and S-norketamine are both similar in treatment groups. The clearance of esketamine in two groups was 18.1±3.2 and 18.4±3.4 mL/min•kg, respectively. However, in the ketamine group, esketamine has a larger clearance than R-ketamine (18.4±3.4 mL/min·kg vs 15.8±3.1 mL/min·kg,  P <0.001). Further analysis showed that gender did not affect the pharmacokinetics of esketamine and racemate ketamine. Regarding the safety of esketamine and racemate ketamine, no serious adverse events were observed during treatment, and the incidences of adverse events were 75.0% (esketamine) and 87.5% (racemate ketamine). The main adverse reactions were dizziness, agitation, nausea, vomiting, headache, and fatigue. However, compared with racemic ketamine, esketamine offers a shorter recovery time (9 mins vs. 13 mins, P<0.05) and orientation recovery time (11.5 mins vs. 17 mins, P<0.05) after short anesthesia.
Conclusion


Esketamine administration as a single dose of 0.5 mg/kg was generally safe and tolerated in patients undergoing painless gastroscopy. In terms of anesthesia, a relatively small dose of esketamine can be used instead of racemate ketamine for routine treatment without consideration of gender differences.",2019,"The concentrations of esketamine, R-ketamine, S-norketamine, and R-norketamine were measured with a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) method.
","['32 patients undergoing painless gastroscopy', 'Chinese Patients Undergoing Painless Gastroscopy in Comparison with', 'patients undergoing painless gastroscopy', 'Chinese patients undergoing painless gastroscopy']","['Esketamine', 'Ketamine', 'esketamine and racemate ketamine', 'racemate ketamine hydrochloride injection', 'esketamine', 'ketamine', 'pure S-ketamine (esketamine', 'racemic ketamine, esketamine', 'racemic ketamine']","['serious adverse events', 'concentrations of esketamine, R-ketamine, S-norketamine, and R-norketamine', 'shorter recovery time', 'dizziness, agitation, nausea, vomiting, headache, and fatigue', 'safe and tolerated', 'orientation recovery time', 'incidences of adverse events', 'clearance of esketamine']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0234226', 'cui_str': 'Painless (qualifier value)'}, {'cui': 'C0017195', 'cui_str': 'Gastroscopy'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C2825616'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0700541', 'cui_str': 'Ketamine Hydrochloride'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C2825616'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0068996', 'cui_str': 'N-desmethylketamine'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0029266', 'cui_str': 'Cognitive Orientation'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}]",,0.0407046,"The concentrations of esketamine, R-ketamine, S-norketamine, and R-norketamine were measured with a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) method.
","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Center for Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan 410013, People's Republic of China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': ""Center for Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan 410013, People's Republic of China.""}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ""Center for Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan 410013, People's Republic of China.""}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Cui', 'Affiliation': ""Center for Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan 410013, People's Republic of China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Ye', 'Affiliation': ""Center for Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan 410013, People's Republic of China.""}, {'ForeName': 'Sai-Ying', 'Initials': 'SY', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, The Third Xiangya Hospital, Central South University, Changsha, Hunan 410013, People's Republic of China.""}, {'ForeName': 'Guo-Ping', 'Initials': 'GP', 'LastName': 'Yang', 'Affiliation': ""Center for Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan 410013, People's Republic of China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Pei', 'Affiliation': ""Center for Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan 410013, People's Republic of China.""}]","Drug design, development and therapy",['10.2147/DDDT.S224553']
1692,26004421,"The Feasibility and Acceptability to Service Users of CIRCuiTS, a Computerized Cognitive Remediation Therapy Programme for Schizophrenia.","BACKGROUND


Cognitive remediation (CR) is a psychological therapy, effective in improving cognitive performance and functioning in people with schizophrenia. As the therapy becomes more widely implemented within mental health services its longevity and uptake is likely to depend on its feasibility and acceptability to service users and clinicians.
AIMS


To assess the feasibility and acceptability of a new strategy-based computerized CR programme (CIRCuiTS) for people with psychosis.
METHOD


Four studies were conducted using mixed methods. Perceptions of attractiveness, comprehensibility, acceptability and usability were assessed using self-report questionnaires in 34 non-clinical participants (study 1), and five people with a schizophrenia diagnosis and three experienced CR therapists (studies 2 and 3). The ease with which pre-specified therapy programmes could be assembled was also assessed by three therapists (Study 2). Finally, the satisfaction of 20 service users with a diagnosis of schizophrenia regarding their experience of using CIRCuiTS in the context of a course of the CR therapy was assessed in a qualitative interview study (study 4).
RESULTS


Ratings of perceived attractiveness, comprehensibility, acceptability and usability consistently exceeded pre-set high targets by non-clinical, clinical and therapist participants. Qualitative analysis of satisfaction with CIRCuiTS showed that receiving the therapy was generally seen to be a positive experience, leading to perceptions that cognitive functioning had improved and attempts to incorporate new strategy use into daily activities.
CONCLUSIONS


CIRCuiTS demonstrates high acceptability and ease of use for both service users with a schizophrenia diagnosis and clinicians.",2016,"Perceptions of attractiveness, comprehensibility, acceptability and usability were assessed using self-report questionnaires in 34 non-clinical participants (study 1), and five people with a schizophrenia diagnosis and three experienced CR therapists (studies 2 and 3).","['people with schizophrenia', '20 service users with a diagnosis of schizophrenia regarding their experience of using', 'people with psychosis', 'Schizophrenia', '34 non-clinical participants (study 1), and five people with a schizophrenia diagnosis and three experienced CR therapists (studies 2 and 3']","['CIRCuiTS', 'Cognitive remediation (CR', 'new strategy-based computerized CR programme (CIRCuiTS']","['Ratings of perceived attractiveness, comprehensibility, acceptability and usability', 'Perceptions of attractiveness, comprehensibility, acceptability and usability', 'feasibility and acceptability']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",34.0,0.0679773,"Perceptions of attractiveness, comprehensibility, acceptability and usability were assessed using self-report questionnaires in 34 non-clinical participants (study 1), and five people with a schizophrenia diagnosis and three experienced CR therapists (studies 2 and 3).","[{'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Reeder', 'Affiliation': ""Institute of Psychiatry,Psychology and Neuroscience,King's College London,UK.""}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Pile', 'Affiliation': ""Institute of Psychiatry,Psychology and Neuroscience,King's College London,UK.""}, {'ForeName': 'Polly', 'Initials': 'P', 'LastName': 'Crawford', 'Affiliation': ""Institute of Psychiatry,Psychology and Neuroscience,King's College London,UK.""}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Cella', 'Affiliation': ""Institute of Psychiatry,Psychology and Neuroscience,King's College London,UK.""}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Rose', 'Affiliation': ""Institute of Psychiatry,Psychology and Neuroscience,King's College London,UK.""}, {'ForeName': 'Til', 'Initials': 'T', 'LastName': 'Wykes', 'Affiliation': ""Institute of Psychiatry,Psychology and Neuroscience,King's College London,UK.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Watson', 'Affiliation': 'University College London,UK.'}, {'ForeName': 'Vyv', 'Initials': 'V', 'LastName': 'Huddy', 'Affiliation': 'University College London,UK.'}, {'ForeName': 'Felicity', 'Initials': 'F', 'LastName': 'Callard', 'Affiliation': 'University of Durham,UK.'}]",Behavioural and cognitive psychotherapy,['10.1017/S1352465815000168']
1693,32418236,Post-treatment endodontic pain following occlusal reduction in mandibular posterior teeth with symptomatic irreversible pulpitis and sensitivity to percussion: a single-centre randomized controlled trial.,"AIM


This randomized, prospective, controlled trial assessed the effect of occlusal reduction on post-treatment endodontic pain and medication intake following root canal treatment of mandibular posterior teeth with symptomatic irreversible pulpitis with sensitivity to percussion treated in two visits.
METHODOLOGY


Three hundred and eight patients were randomly assigned into two equal groups according to whether occlusal reduction was done or not (n = 154). For all patients, root canal treatment was carried out in two visits without intracanal medication. Patients assessed their pain using the 0-10 numerical rating scale (NRS) 6, 12, 24 and 48 h after the first visit (post-instrumentation) and 6 and 12 h following root canal filling (post-obturation). Patients, also, recorded their medication intake (sham or analgesic), post-instrumentation and post-obturation; patients initially received a sham capsule, but, if pain persisted, an analgesic was prescribed. Data were analysed using Mann-Whitney U-test, Friedman's test, Wilcoxon's rank test and chi-square (χ 2  ) test. The relative risk (RR) and its 95% confidence interval (CI) were calculated for binary data.
RESULTS


Occlusal reduction was associated with lower pain intensity than no occlusal reduction at 12 and 24 h post-instrumentation (P < 0.05). Pain intensity significantly and gradually decreased with both groups at all post-instrumentation and post-obturation time-points compared to preoperative pain (P < 0.05). The RR of moderate-to-severe pain was 0.61 (95% CI: 0.41, 0.91) 12 h post-instrumentation, and the RR of pain incidence, regardless of its level, was 0.75 (95% CI: 0.61, 0.92) 24 h post-instrumentation. There was no significant difference in medication intake (sham or analgesic) between groups (P > 0.05).
CONCLUSIONS


Occlusal reduction was effective in reducing the intensity of postoperative pain 12 h and 24 h after root canal instrumentation in the first visit in patients with symptomatic irreversible pulpitis with sensitivity to percussion. Occlusal reduction lowered the risk of moderate-to-severe pain by about 40% 12 h post-instrumentation and the overall risk of pain by 25% 24 h post-instrumentation; yet, it did not affect medication intake.",2020,Pain intensity significantly and gradually decreased with both groups at all postinstrumentation and postobturation timepoints compared to preoperative pain (p<0.05).,"['mandibular posterior teeth with symptomatic irreversible pulpitis and sensitivity to percussion', 'Three hundred and eight patients', 'mandibular posterior teeth with symptomatic irreversible pulpitis with sensitivity to percussion treated in two visits', 'patients with symptomatic irreversible pulpitis with sensitivity to percussion']","['occlusal reduction', 'root canal treatment']","['Postendodontic pain', 'pain intensity', 'postendodontic pain and medication intake', 'Pain intensity', 'Relative Risk (RR) and its 95% confidence interval (CI', 'RR of pain incidence', 'intensity of postoperative pain', 'overall risk of pain', 'RR of moderate-to-severe pain', 'risk of moderate-to-severe pain', 'medication intake']","[{'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C4039735', 'cui_str': 'Symptomatic irreversible pulpitis'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0030987', 'cui_str': 'Percussion'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]",308.0,0.181418,Pain intensity significantly and gradually decreased with both groups at all postinstrumentation and postobturation timepoints compared to preoperative pain (p<0.05).,"[{'ForeName': 'Y E', 'Initials': 'YE', 'LastName': 'Ahmed', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Emara', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Sarhan', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'El Boghdadi', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'M A A', 'Initials': 'MAA', 'LastName': 'El-Bayoumi', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'H M M', 'Initials': 'HMM', 'LastName': 'El-Far', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'N E', 'Initials': 'NE', 'LastName': 'Sabet', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Abou El-Nasr', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'S I', 'Initials': 'SI', 'LastName': 'Gawdat', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'S A W', 'Initials': 'SAW', 'LastName': 'Amin', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}]",International endodontic journal,['10.1111/iej.13328']
1694,25743855,"Aprepitant versus metoclopramide, both combined with dexamethasone, for the prevention of cisplatin-induced delayed emesis: a randomized, double-blind study.","BACKGROUND


A combination of aprepitant, a 5-HT3 receptor antagonist (r.a.), and dexamethasone is recommended for the prophylaxis of cisplatin-induced nausea and vomiting in the acute phase, and aprepitant + dexamethasone (A + D) in the delayed phase. The aim of this study was to verify if A + D is superior to metoclopramide plus dexamethasone (M + D) in preventing delayed emesis in cancer patients receiving the same prophylaxis for acute emesis.
PATIENTS AND METHODS


A randomized double-blind study comparing A + D versus M + D was completed in previously untreated cancer patients. Before chemotherapy, all patients were treated with intravenous palonosetron 0.25 mg and dexamethasone 12 mg, and oral aprepitant 125 mg. On day 2-4, patients randomly received oral dexamethasone 8 mg plus aprepitant 80 mg once daily (days 2-3) or metoclopramide 20 mg four times daily plus dexamethasone 8 mg bid. Primary endpoint was rate of complete response (no vomiting, no rescue treatment) in day 2-5 after chemotherapy.
RESULTS


Due to difficulty in the accrual of patients, 303 of the 480 planned patients were enrolled, 284 were fully evaluable, 147 receiving A + D, 137 M + D. Day 1 results were similar in both arms. On day 2-5, complete response rate was not significantly different (80.3% with A + D versus 82.5% with M + D, P < 0.38, respectively), and all secondary endpoints were also similar (complete protection, total control, no vomiting, no nausea, and score of Functional Living Index-Emesis; P < 0.24). Adverse events incidence was not significantly different between the two treatments.
CONCLUSIONS


In cancer patients submitted to cisplatin-based chemotherapy, receiving the same antiemetic prophylaxis for acute emesis, A + D is not superior to M + D in preventing delayed emesis, and both treatments present similar toxicity.
CLINICALTRIALSGOV NUMBER


NCT00869310.",2015,"Adverse events incidence was not significantly different between the two treatments.
","['cancer patients receiving the same prophylaxis for acute emesis', 'previously untreated cancer patients', ' 303 of the 480 planned patients were enrolled, 284 were fully evaluable, 147 receiving A + D, 137 M + D. Day 1 results were similar in both arms']","['metoclopramide', 'cisplatin', 'dexamethasone', 'metoclopramide plus dexamethasone (M + D', ' D versus M + D', 'oral dexamethasone', 'cisplatin-based chemotherapy', 'intravenous palonosetron 0.25 mg and dexamethasone', 'metoclopramide 20 mg four times daily plus dexamethasone']","['Adverse events incidence', 'rate of complete response (no vomiting, no rescue treatment', 'total control, no vomiting, no nausea, and score of Functional Living Index-Emesis', 'complete response rate', 'delayed emesis']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms (body structure)'}]","[{'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4691686', 'cui_str': 'palonosetron 0.25 MG'}, {'cui': 'C0585291', 'cui_str': 'Four times daily (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0375548', 'cui_str': 'No vomiting'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0423584', 'cui_str': 'No nausea'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}]",,0.273069,"Adverse events incidence was not significantly different between the two treatments.
","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Roila', 'Affiliation': ""Medical Oncology Division, 'S. Maria' Hospital, Terni. Electronic address: roila.fausto@libero.it.""}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Ruggeri', 'Affiliation': 'Clinical Governance, ASUR Marche, Ascoli Piceno.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ballatori', 'Affiliation': ""Internal Medicine and Public Health, University of L'Aquila, Spinetoli.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Fatigoni', 'Affiliation': ""Medical Oncology Division, 'S. Maria' Hospital, Terni.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Caserta', 'Affiliation': ""Medical Oncology Division, 'S. Maria' Hospital, Terni.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Licitra', 'Affiliation': 'Medical Oncology, National Cancer Institute, Milano.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mirabile', 'Affiliation': 'Medical Oncology, National Cancer Institute, Milano.'}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Ionta', 'Affiliation': 'Medical Oncology II, University Hospital, Cagliari.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Massidda', 'Affiliation': 'Medical Oncology II, University Hospital, Cagliari.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Cavanna', 'Affiliation': 'Medical Oncology, Piacenza Hospital, Piacenza.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Palladino', 'Affiliation': 'Medical Oncology, Piacenza Hospital, Piacenza.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tocci', 'Affiliation': 'Medical Oncology, Azienda Ospedaliera di Legnano, Legnano.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Fava', 'Affiliation': 'Medical Oncology, Azienda Ospedaliera di Legnano, Legnano.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Colantonio', 'Affiliation': 'Medical Oncology, Santa Croce e Carle Hospital, Cuneo.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Angelelli', 'Affiliation': 'Medical Oncology, ASUR Marche, Ascoli Piceno.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ciuffreda', 'Affiliation': 'Medical Oncology, Molinette Hospital, Torino.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Fasola', 'Affiliation': 'Medical Oncology, University Hospital S. Maria della Misericordia, Udine.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Zerilli', 'Affiliation': 'Medical Oncology, S. Antonio Abate Hospital, Trapani, Italy.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdv132']
1695,25810961,A comparative evaluation of magnesium sulphate and nitroglycerine as potential adjuncts to lidocaine in intravenous regional anaesthesia.,"INTRODUCTION


This randomized control trial was carried out to evaluate and compare the efficacy of magnesium sulphate and nitroglycerine (NTG) as adjuncts to lidocaine in intravenous regional anesthesia (IVRA).
MATERIALS AND METHODS


Seventy-five, ASA grade I and II patients, aged between 20-50 years, scheduled for hand and forearm surgery were selected and entered randomly into three study groups. Patients in group C received 3 mg/kg of preservative free lidocaine 2% diluted with saline to a total volume of 40 ml. Patients in group M received 3 mg/kg of preservative free lidocaine 2% mixed with 6 ml of 25% magnesium sulphate (1.5 g) diluted with saline to a total volume of 40 ml. Patients in group N received 3 mg/kg of preservative free lidocaine 2% mixed with 200 μg of nitroglycerine diluted with saline to a total volume of 40 ml. Sensory and motor block onset and recovery time, tourniquet pain onset time, intraoperative fentanyl requirement, the total number of patients requiring rescue analgesia and the time to first analgesia requirement, intra-operative and postoperative degree of analgesia were evaluated.
RESULTS


The sensory and motor block onset times were shorter in group M and N as compared to group C (P- = 0.004, 0.0036 for sensory block, 0.021, 0.038 for motor block. The mean time of onset of sensory block was earliest in group M and the mean time of onset of motor block was earliest in group N. Mean time of onset of tourniquet pain in the three groups was similar in groups M and N. The sensory and motor block recovery time were significantly prolonged in M and N group as compared to group C (P < 0.001). Intraoperative fentanyl requirement (P value- = 0.041), the total number of patients requiring rescue analgesia (P value = 0.009) and the time to first analgesia requirement (P value = 0.038) were lower in group M.
CONCLUSION


The addition of both magnesium suphate and nitroglycerin (NTG) to lidocaine for intravenous regional anesthesia (IVRA) leads to early onset of sensory block and prolonged postoperative analgesia, with no side effects.",2015,"The sensory and motor block onset times were shorter in group M and N as compared to group C (P- = 0.004, 0.0036 for sensory block, 0.021, 0.038 for motor block.","['Seventy-five, ASA grade', 'I and II patients, aged between 20-50 years, scheduled for hand and forearm surgery', 'intravenous regional anaesthesia']","['magnesium sulphate and nitroglycerine', '3 mg/kg of preservative free lidocaine', 'nitroglycerine diluted with saline', 'lidocaine', 'magnesium sulphate and nitroglycerine (NTG', '3 mg/kg of preservative free lidocaine 2% diluted with saline', 'preservative free lidocaine 2% mixed with 6 ml of 25% magnesium sulphate (1.5 g) diluted with saline', 'magnesium suphate and nitroglycerin (NTG']","['mean time of onset of motor block', 'total number of patients requiring rescue analgesia', 'Mean time of onset of tourniquet pain', 'time to first analgesia requirement', 'sensory and motor block recovery time', 'mean time of onset of sensory block', 'sensory and motor block onset times', 'Sensory and motor block onset and recovery time, tourniquet pain onset time, intraoperative fentanyl requirement, the total number of patients requiring rescue analgesia and the time to first analgesia requirement, intra-operative and postoperative degree of analgesia', 'Intraoperative fentanyl requirement']","[{'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0002911', 'cui_str': 'Anesthesia, Regional'}]","[{'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449244', 'cui_str': 'Time of onset (observable entity)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}]",,0.227712,"The sensory and motor block onset times were shorter in group M and N as compared to group C (P- = 0.004, 0.0036 for sensory block, 0.021, 0.038 for motor block.","[{'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Bansal', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Government Medical College, Jammu, Jammu and Kashmir, India.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Baduni', 'Affiliation': ""Department of Anesthesiology and Intensive Care, Employees' State Insurance Corporation, Rohini, New Delhi, India.""}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Bhalla', 'Affiliation': ""Department of Anesthesiology and Intensive Care, Employees' State Insurance Corporation, Rohini, New Delhi, India.""}, {'ForeName': 'Bablesh', 'Initials': 'B', 'LastName': 'Mahawar', 'Affiliation': ""Department of Anesthesiology and Intensive Care, Employees' State Insurance Corporation, Rohini, New Delhi, India.""}]",International journal of critical illness and injury science,['10.4103/2229-5151.152324']
1696,32424499,Does physiotherapy applied in conjunction with compression brace treatment in patients with pectus carinatum have efficacy? A preliminary randomized-controlled study.,"PURPOSE


Non-invasive treatment of pectus carinatum (PC) deformity includes the use of a compression brace and exercises. In this study, we aimed to examine the effect of a physiotherapy protocol applied as adjunct to compression brace treatment in patients with PC.
METHODS


The study included 30 male patients between 11 and 18 years of age. Patients were randomly assigned into two groups: a brace treatment only group (Group 1) and a brace and physiotherapy group (Group 2). Patient demographics and disease-related properties, protrusion measurements, postural evaluations, deformity perceptions, life quality, and treatment satisfaction were evaluated.
RESULTS


Although both groups showed improvements based on external chest measurements related to PC protrusion following treatment (p < 0.001), Group 2 had more benefit from the treatment (effect size > 0.36) and displayed greater improvement in maximum protrusion degree and lateral length values (p < 0.05). Additionally, we found that patient perception of deformity, posture, psychological life quality, and treatment satisfaction scores were significantly better in Group 2 (p < 0.05).
CONCLUSION


Owing to the satisfaction and additional benefits observed in the physiotherapy group, we think that a proper cardiopulmonary and musculoskeletal exercise program should be applied concurrently with brace treatment for patients with PC deformity. Nevertheless, long-term outcomes need to be clarified in future studies.",2020,"Although both groups showed improvements based on external chest measurements related to PC protrusion following treatment (p < 0.001), Group 2 had more benefit from the treatment (effect size > 0.36) and displayed greater improvement in maximum protrusion degree and lateral length values (p < 0.05).","['patients with pectus carinatum', 'patients with PC deformity', 'patients with PC', '30 male patients between 11 and 18\xa0years of age']","['physiotherapy protocol', 'compression brace and exercises', 'brace treatment only group (Group 1) and a brace and physiotherapy', 'musculoskeletal exercise program']","['Patient demographics and disease-related properties, protrusion measurements, postural evaluations, deformity perceptions, life quality, and treatment satisfaction', 'maximum protrusion degree and lateral length values', 'patient perception of deformity, posture, psychological life quality, and treatment satisfaction scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0158731', 'cui_str': 'Congenital pectus carinatum'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0333056', 'cui_str': 'Protrusion'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",30.0,0.0533754,"Although both groups showed improvements based on external chest measurements related to PC protrusion following treatment (p < 0.001), Group 2 had more benefit from the treatment (effect size > 0.36) and displayed greater improvement in maximum protrusion degree and lateral length values (p < 0.05).","[{'ForeName': 'Nuray', 'Initials': 'N', 'LastName': 'Alaca', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Acibadem Mehmet Ali Aydinlar University, Kerem Aydınlar Kampusu, Icerenkoy Mah. Kayısdagı Cad. No:32, Atasehir, 34752, Istanbul, Turkey. nuray.alaca@acibadem.edu.tr.'}, {'ForeName': 'İhsan', 'Initials': 'İ', 'LastName': 'Alaca', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Acibadem Mehmet Ali Aydinlar University, Kerem Aydınlar Kampusu, Icerenkoy Mah. Kayısdagı Cad. No:32, Atasehir, 34752, Istanbul, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Yüksel', 'Affiliation': 'Chest Wall Deformities and Pectus Association, Zuhtupasa Mah. Kadıkoy, Istanbul, Turkey.'}]",Pediatric surgery international,['10.1007/s00383-020-04675-3']
1697,31689141,A Randomized Controlled Trial of Telemedicine for Long-Term Sleep Apnea Continuous Positive Airway Pressure Management.,"Rationale:  The effects of telemedicine on adherence in patients with obstructive sleep apnea with long-term continuous positive airway pressure (CPAP) use have never been investigated. Objectives:  To examine effects of a telemedicine intervention on adherence in long-term CPAP users. Methods:  In a prospective, randomized, multicenter noninferiority trial conducted in 17 sleep centers across Japan, patients who had used CPAP for >3 months and were receiving face-to-face follow-up by physicians every 1 or 2 months were randomized by a coordinating center in a blind manner to the following three groups:  1 ) follow-up every 3 months accompanied by a monthly telemedicine intervention (telemedicine group: TM-group),  2 ) follow-up every 3 months (3-month group: 3M-group), or  3 ) monthly follow-up (1-month group: 1M-group). Each group was followed up for 6 months. The change in percentage of days with ≥4 h/night of CPAP use from baseline to the end of the study period was evaluated. A decline of ≥5% from baseline was considered deterioration of adherence. Noninferiority of TM- and 3M-groups compared with the 1M-group according to the number of patients with deterioration of adherence was evaluated with the Farrington and Manning test (noninferiority margin 15%). Results:  A total of 483 patients were analyzed (median duration of CPAP use, 29 [interquartile range, 12-71] mo), and deterioration of adherence was found in 41 of 161 (25.5%), 55 of 166 (33.1%), and 35 of 156 (22.4%) patients in the TM-, 3M-, and 1M-groups, respectively. The noninferiority of the TM-group compared with the 1M-group was verified (difference in percentage of patients with adherence deterioration, 3.0%; 95% confidence interval [CI], -4.8% to 10.9%;  P  < 0.01). Conversely, the 3M-group did not show noninferiority to the 1M-group (percentage difference, 10.7%; 95% CI, 2.6% to 18.8%;  P  = 0.19). In the stratified analysis, adherence in TM- and 1M-group patients with poor adherence at baseline improved (TM: 45.8% ± 18.2% to 57.3% ± 24.4%;  P  < 0.01; 1M: 43.1% ± 18.5% to 53.6% ± 24.3%;  P  < 0.01), whereas that of the 3M-group did not (39.3% ± 20.8% to 39.8% ± 24.8%;  P  = 0.84). Conclusions:  Intensive telemedicine support could help to optimize CPAP adherence even after long-term CPAP use.Clinical trial registered with www.umin.ac.jp/ctr/index.htm (trial number: UMIN000023118).",2020,"Conversely, the 3M-group did not show non-inferiority to the 1M-group (% difference 10.7%, 95% CI 2.6-18.8%, p=0.19).","['17 sleep centers across Japan, patients who had used CPAP for more than 3 months and were receiving face-to-face follow-up by physicians every one or two months', 'obstructive sleep apnea patients with long-term continuous positive airway pressure (CPAP']","['Telemedicine', 'telemedicine intervention', 'telemedicine', 'telemedicine intervention (Telemedicine group: TM', 'TM- and 3M']","['deterioration of adherence', 'CPAP adherence']","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}]",483.0,0.0924678,"Conversely, the 3M-group did not show non-inferiority to the 1M-group (% difference 10.7%, 95% CI 2.6-18.8%, p=0.19).","[{'ForeName': 'Kimihiko', 'Initials': 'K', 'LastName': 'Murase', 'Affiliation': 'Department of Respiratory Care and Sleep Control Medicine.'}, {'ForeName': 'Kiminobu', 'Initials': 'K', 'LastName': 'Tanizawa', 'Affiliation': 'Department of Respiratory Medicine.'}, {'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Minami', 'Affiliation': 'Department of Respiratory Medicine.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Respiratory Medicine.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Tachikawa', 'Affiliation': 'Department of Respiratory Medicine.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Takahashi', 'Affiliation': 'Department of Respiratory Care and Sleep Control Medicine.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Tsuda', 'Affiliation': 'Sleep Center, Kirigaoka Tsuda Hospital, Kitakyusyu, Japan.'}, {'ForeName': 'Yoshiro', 'Initials': 'Y', 'LastName': 'Toyama', 'Affiliation': 'Sleep Medical Center, Osaka Kaisei Hospital, Osaka, Japan.'}, {'ForeName': 'Motoharu', 'Initials': 'M', 'LastName': 'Ohi', 'Affiliation': 'Sleep Medical Center, Osaka Kaisei Hospital, Osaka, Japan.'}, {'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Akahoshi', 'Affiliation': 'Shinjuku Sleep and Respiratory Clinic, Tokyo, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Tomita', 'Affiliation': 'Sleep Center, Toranomon Hospital, Tokyo, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Narui', 'Affiliation': 'Sleep Center, Toranomon Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nakamura', 'Affiliation': 'Nakamura Clinic, Urazoe, Japan.'}, {'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Ohdaira', 'Affiliation': 'Department of Respiratory Medicine, Nishi-Niigata Chuo National Hospital, Niigata, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Yoshimine', 'Affiliation': 'Inoue Hospital, Shunkaikai, Nagasaki, Japan.'}, {'ForeName': 'Tomomasa', 'Initials': 'T', 'LastName': 'Tsuboi', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Minami Kyoto Hospital, Joyo, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Yamashiro', 'Affiliation': 'Ureshinogaoka Samaritan Hospital, Okinawa, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Ando', 'Affiliation': 'Sleep Apnea Center, Kyushu University Hospital, Fukuoka, Japan.'}, {'ForeName': 'Takatoshi', 'Initials': 'T', 'LastName': 'Kasai', 'Affiliation': 'Cardiovascular Respiratory Sleep Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Kita', 'Affiliation': 'Department of Respiratory Medicine, Takatsuki Red Cross Hospital, Takatsuki, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Tatsumi', 'Affiliation': 'Department of Respirology, Graduate School of Medicine, Chiba University, Chiba, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Burioka', 'Affiliation': 'Department of Pathobiological Science and Technology, School of Health Science, Tottori University Faculty of Medicine, Tottori, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Tomii', 'Affiliation': 'Department of Respiratory Medicine, Kobe City Medical Center General Hospital, Kobe, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Kondoh', 'Affiliation': 'Department of Respiratory Medicine and Allergy, Tosei General Hospital, Seto, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Takeyama', 'Affiliation': 'Department of Respiratory Care and Sleep Control Medicine.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Handa', 'Affiliation': 'Department of Advanced Medicine for Respiratory Failure, and.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Hamada', 'Affiliation': 'Department of Advanced Medicine for Respiratory Failure, and.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Oga', 'Affiliation': 'Department of Respiratory Medicine.'}, {'ForeName': 'Takeo', 'Initials': 'T', 'LastName': 'Nakayama', 'Affiliation': 'Department of Health Informatics, Kyoto University School of Public Health, Kyoto, Japan.'}, {'ForeName': 'Tetsuo', 'Initials': 'T', 'LastName': 'Sakamaki', 'Affiliation': 'System Integration Center, Gunma University, Gunma, Japan; and.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Department of Biomedical Statistics and Bioinformatics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Kuroda', 'Affiliation': 'Division of Medical Information Technology and Administration Planning, Kyoto University Hospital, Kyoto, Japan.'}, {'ForeName': 'Toyohiro', 'Initials': 'T', 'LastName': 'Hirai', 'Affiliation': 'Department of Respiratory Medicine.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Chin', 'Affiliation': 'Department of Respiratory Care and Sleep Control Medicine.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201907-494OC']
1698,31313021,Oxidative stress and inflammatory profiles in obstructive sleep apnea: are short-term CPAP or aerobic exercise therapies effective?,"PURPOSE


The effects of medium to long-term continuous positive airway pressure (CPAP) or physical activity in decreasing oxidative stress, inflammatory, and cell-free DNA markers in obstructive sleep apnea (OSA) have been explored. Here we evaluate oxidative stress markers (TBARS, AOPP, SOD), proinflammatory cytokines (TNF-α, IL-1β, IL-6, IL-8), anti-inflammatory cytokines (IL-4, IL-10), and cell-free DNA levels before and after 8-week CPAP treatment or moderate-intensity aerobic training in moderate to severe OSA.
METHODS


Thirty-nine patients diagnosed with OSA were randomly divided into CPAP (N = 18), with or without humidifier, and exercise groups (N = 21). Excessive daytime sleepiness and sleep quality were assessed by the Epworth Sleepiness Scale and the Pittsburgh questionnaire, respectively. Biomarkers for lipid and protein oxidation, pro and anti-inflammatory cytokines, and cell-free DNA were quantified in blood samples, before and after 8 weeks of both treatments.
RESULTS


After 8 weeks of either CPAP or exercise, no significant differences were observed in the levels of cell-free DNA, oxidative stress, and inflammation markers, except for an increase in AOPP and IL-17A levels in individuals who went through CPAP, which were higher when the CPAP device was used without the humidifier. We have also observed that CPAP significantly decreased the Pittsburgh scores and improved sleep efficiency and hours of sleep, while ESS scores remained unaffected.
CONCLUSIONS


Short-term treatment for OSA, be it CPAP therapy or moderate-intensity aerobic exercise, was not sufficient to alter either the oxidative stress and inflammatory profiles or the cell-free DNA levels of moderate to severe OSA patients. Short-term CPAP did, however, improve self-reported sleep quality.",2020,"After 8 weeks of either CPAP or exercise, no significant differences were observed in the levels of cell-free DNA, oxidative stress, and inflammation markers, except for an increase in AOPP and IL-17A levels in individuals who went through CPAP, which were higher when the CPAP device was used without the humidifier.","['Thirty-nine patients diagnosed with OSA', 'obstructive sleep apnea (OSA', 'obstructive sleep apnea']","['medium to long-term continuous positive airway pressure (CPAP) or physical activity', 'CPAP treatment or moderate-intensity aerobic training', 'CPAP']","['oxidative stress markers (TBARS, AOPP, SOD), proinflammatory cytokines (TNF-α, IL-1β, IL-6, IL-8), anti-inflammatory cytokines (IL-4, IL-10), and cell-free DNA levels', 'Excessive daytime sleepiness and sleep quality', 'AOPP and IL-17A levels', 'Pittsburgh scores and improved sleep efficiency and hours of sleep, while ESS scores', 'lipid and protein oxidation, pro and anti-inflammatory cytokines, and cell-free DNA', 'Oxidative stress and inflammatory profiles', 'Epworth Sleepiness Scale and the Pittsburgh questionnaire', 'levels of cell-free DNA, oxidative stress, and inflammation markers', 'self-reported sleep quality']","[{'cui': 'C3816447', 'cui_str': '39 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0162781', 'cui_str': 'TBARs'}, {'cui': 'C1976991', 'cui_str': 'AOPPs'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C4289789', 'cui_str': 'Cell-Free Deoxyribonucleic Acid'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4551761', 'cui_str': 'Excessive daytime sleepiness'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1705947', 'cui_str': 'CTLA8'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C3541276', 'cui_str': 'ESS - Epworth Sleepiness Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}]",39.0,0.0166835,"After 8 weeks of either CPAP or exercise, no significant differences were observed in the levels of cell-free DNA, oxidative stress, and inflammation markers, except for an increase in AOPP and IL-17A levels in individuals who went through CPAP, which were higher when the CPAP device was used without the humidifier.","[{'ForeName': 'Ytalo Gonçalves', 'Initials': 'YG', 'LastName': 'Borges', 'Affiliation': 'Physiological Sciences Graduation Program, Health Sciences Center, Federal University of Espírito Santo, Av. Marechal Campos 1468, Maruípe, Vitória, ES, 29040-900, Brazil.'}, {'ForeName': 'Luis Henrique Ceia', 'Initials': 'LHC', 'LastName': 'Cipriano', 'Affiliation': 'Physiological Sciences Graduation Program, Health Sciences Center, Federal University of Espírito Santo, Av. Marechal Campos 1468, Maruípe, Vitória, ES, 29040-900, Brazil.'}, {'ForeName': 'Rafaela', 'Initials': 'R', 'LastName': 'Aires', 'Affiliation': 'Physiological Sciences Graduation Program, Health Sciences Center, Federal University of Espírito Santo, Av. Marechal Campos 1468, Maruípe, Vitória, ES, 29040-900, Brazil.'}, {'ForeName': 'Paulo Vinicios Camuzi', 'Initials': 'PVC', 'LastName': 'Zovico', 'Affiliation': 'Physical Education Graduation Program, Physical Education and Sports Center, Federal University of Espírito Santo, Av. Marechal Campos 1468, Maruípe, Vitória, ES, 29040-090, Brazil.'}, {'ForeName': 'Fabiana Vasconcelos', 'Initials': 'FV', 'LastName': 'Campos', 'Affiliation': 'Biochemistry Graduation Program, Physiological Sciences Department, Federal University of Espírito Santo, Av. Marechal Campos 1468, Maruípe, Vitória, ES, 29040-090, Brazil.'}, {'ForeName': 'Maria Teresa Martins', 'Initials': 'MTM', 'LastName': 'de Araújo', 'Affiliation': 'Physiological Sciences Graduation Program, Health Sciences Center, Federal University of Espírito Santo, Av. Marechal Campos 1468, Maruípe, Vitória, ES, 29040-900, Brazil. maraujo.27@hotmail.com.'}, {'ForeName': 'Sonia Alves', 'Initials': 'SA', 'LastName': 'Gouvea', 'Affiliation': 'Physiological Sciences Graduation Program, Health Sciences Center, Federal University of Espírito Santo, Av. Marechal Campos 1468, Maruípe, Vitória, ES, 29040-900, Brazil.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-019-01898-0']
1699,31222029,Truels and strategies for survival.,"The truel is a three person competition that generalises the classic duel. In this game three players try to eliminate each other in a series of one-to-one duels until there is only one survivor. The players' marksmanship, shooting order and strategies for choosing a target play a significant role in individual's survival probability. Strategies such as shooting into the air (abstention), shooting at the strongest opponent, and shooting at the weakest opponent have been analysed in the previous literature. In this paper, for the first time, we consider suicidal and random strategies that can be chosen by the weaker player. We show that although there is no possible highest probability region for weakest player adopting suicidal strategy, the player may increase the survival probability via switching between suicidal and abstention strategies randomly. In addition, we demonstrate that there is a narrow survival area for the weakest player when the player aims randomly at two other opponents, and eventually the area fades away if the player fires randomly at himself or the other two opponents.",2019,"The players' marksmanship, shooting order and strategies for choosing a target play a significant role in individual's survival probability.",[],[],['survival probability'],[],[],"[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",,0.0295202,"The players' marksmanship, shooting order and strategies for choosing a target play a significant role in individual's survival probability.","[{'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Dorraki', 'Affiliation': 'School of Electrical & Electronic Engineering, University of Adelaide, Adelaide, South Australia, 5005, Australia. mohsen.dorraki@adelaide.edu.au.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Allison', 'Affiliation': 'School of Electrical & Electronic Engineering, University of Adelaide, Adelaide, South Australia, 5005, Australia.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Abbott', 'Affiliation': 'School of Electrical & Electronic Engineering, University of Adelaide, Adelaide, South Australia, 5005, Australia.'}]",Scientific reports,['10.1038/s41598-019-45253-5']
1700,25586331,"Fibrocaps for surgical hemostasis: two randomized, controlled phase II trials.","BACKGROUND


Fibrocaps, a ready-to-use, dry-powder fibrin sealant containing human plasma-derived thrombin and fibrinogen, is being developed as an adjunct for surgical hemostasis.
MATERIALS AND METHODS


Safety and efficacy of Fibrocaps applied directly or by spray device, in combination with gelatin sponge, was compared with that of gelatin sponge-alone in two randomized, single-blind controlled trials: FC-002 US (United States) and FC-002 NL (the Netherlands). A total of 126 adult patients were randomized (Fibrocaps: n = 47 [FC-002 US], n = 39 [FC-002 NL]; gelatin sponge alone: n = 23 [FC-002 US], n = 17 [FC-002 NL). One bleeding site was treated during a surgical procedure (n = 125). Time to hemostasis (primary end point) was measured, with a 28-d safety follow-up. Four surgical indications included hepatic resection (n = 58), spinal procedures (n = 37), peripheral vascular procedures (n = 30), and soft tissue dissection (n = 1).
RESULTS


Mean (standard deviation) time to hemostasis was significantly shorter after Fibrocaps treatment than after gelatin sponge alone (FC-002 US: 1.9 [1.3] versus 4.8 min [3.1], P < 0.001; FC-002 NL: 2.2 [1.3] versus 4.4 min [3.1], P = 0.004). The incidence of hemostasis was greater after Fibrocaps compared with that of gelatin sponge alone within 3 min (FC-002 US: 83% versus 35%, P < 0.001; FC-002 NL: 77% versus 53%, P = 0.11), 5 min (94% versus 61%, P = 0.001; 95% versus 71%, P = 0.022), and 10 min (100% versus 78%, P = 0.003; 100% versus 82%, P = 0.025). Adverse events were consistent with surgical procedures performed and patients' underlying diseases and generally similar between treatment arms; most were mild or moderate in severity. Non-neutralizing antithrombin antibodies were detected in 5% of Fibrocaps-treated patients on day 29.
CONCLUSIONS


Fibrocaps had good safety and efficacy profiles, supporting continuing clinical development as a novel fibrin sealant.",2015,"Non-neutralizing antithrombin antibodies were detected in 5% of Fibrocaps-treated patients on day 29.
","['126 adult patients were randomized (Fibrocaps: n\xa0=\xa047', 'n\xa0=\xa039', 'Four surgical indications included hepatic resection (n\xa0=\xa058), spinal procedures (n\xa0=\xa037), peripheral vascular procedures (n\xa0=\xa030), and soft tissue dissection (n\xa0=\xa01', 'n\xa0=\xa023 [FC-002 US], n\xa0=\xa017 [FC-002 NL']","['gelatin sponge-alone', 'Fibrocaps applied directly or by spray device, in combination with gelatin sponge', 'gelatin sponge alone', 'FC-002 NL]; gelatin sponge alone', 'FC-002 US (United States) and FC-002 NL']","['incidence of hemostasis', 'Adverse events', 'neutralizing antithrombin antibodies', 'Mean (standard deviation) time to hemostasis']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}]","[{'cui': 'C0017237', 'cui_str': 'Gelatin'}, {'cui': 'C1705741', 'cui_str': 'Sponge (basic dose form)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003440', 'cui_str': 'Direct Thrombin Inhibitors'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",126.0,0.0268287,"Non-neutralizing antithrombin antibodies were detected in 5% of Fibrocaps-treated patients on day 29.
","[{'ForeName': 'Cornelis', 'Initials': 'C', 'LastName': 'Verhoef', 'Affiliation': 'Department of Surgical Oncology, Erasmus Medical Center Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Singla', 'Affiliation': 'Department of Anesthesia, Lotus Clinical Research, Huntington Hospital, Pasadena, California.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Moneta', 'Affiliation': 'Division of Vascular Surgery, Oregon Health & Science University Hospital and Clinic, Portland, Oregon.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Muir', 'Affiliation': 'William S. Muir MD Spine Surgery, Las Vegas, Nevada.'}, {'ForeName': 'Arjen', 'Initials': 'A', 'LastName': 'Rijken', 'Affiliation': 'Department of Surgery, Amphia Hospital, Breda, The Netherlands.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Lockstadt', 'Affiliation': 'Bluegrass Orthopedics, Lexington, Kentucky.'}, {'ForeName': 'Johannes H W', 'Initials': 'JHW', 'LastName': 'de Wilt', 'Affiliation': 'Division of Surgical Oncology and Gastrointestinal Surgery, Radboud Univeristy Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'O-Yurvati', 'Affiliation': 'Department of Surgery, University of North Texas Health Science Center, Fort Worth, Texas.'}, {'ForeName': 'Linda A', 'Initials': 'LA', 'LastName': 'Zuckerman', 'Affiliation': 'Department of Clinical Research, ProFibrix BV, The Medicines Company, Seattle, Washington. Electronic address: linda.zuckerman@themedco.com.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Frohna', 'Affiliation': 'Department of Clinical Research, ProFibrix BV, The Medicines Company, Seattle, Washington.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Porte', 'Affiliation': 'Department of Surgery, Section Surgery and Liver Transplantation, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}]",The Journal of surgical research,['10.1016/j.jss.2014.12.011']
1701,25625059,Comparison of i-gel™ and laryngeal mask airway in anesthetized paralyzed patients.,"BACKGROUND


The i-gel™ is a new device introduced recently. It differs from other supraglottic airway devices. It has a non-inflatable, gel-made cuff. Previously used devices, have some disadvantages which are claimed to be absent in i-gel™. In this study we aimed to compare the performance of the laryngeal mask airway (LMA)-Classic™ and i-gel™ during anesthesia in paralyzed patients.
MATERIALS AND METHODS


A total of 64 anaesthetized patients with paralysis were enrolled in a single-blind, randomized control trial to be intubated with one of the devices. We compared the device insertion parameters, some ventilatory parameters, and adverse effects after device insertion.
RESULTS


Vital signs were not significantly different between groups. Regarding duration of insertion attempts, the difference between groups was significant (P < 0.05); while the number of insertion attempts was insignificant (P = 0.265). There was no significant difference between both groups regarding postoperative complications (cough, sore throat, and blood on the cuff) (P > 0.05). Airway leak was assessed in both groups and data showed no significant difference (P = 0.662). Additionally, end-tidal CO2 change regarding the baseline value was significantly different after 10 and 15 min of anesthesia (P < 0.05).
CONCLUSIONS


Successful insertion time was shorter significantly for i-gel™. As i-gel™ has easy application, it is advantageous to be used during cardiopulmonary resuscitation by non-anesthetists in which time is very important. We concluded that i-gel™ can be an alternative to LMA-Classic™ for controlled ventilation during anesthesia as it is easier to be placed.",2014,"There was no significant difference between both groups regarding postoperative complications (cough, sore throat, and blood on the cuff) (P > 0.05).","['anesthetized paralyzed patients', '64 anaesthetized patients with paralysis', 'paralyzed patients']","['laryngeal mask airway (LMA)-Classic™ and i-gel™ during anesthesia', 'i-gel™ and laryngeal mask airway']","['Vital signs', 'tidal CO2 change regarding the baseline value', 'number of insertion attempts', 'postoperative complications (cough, sore throat, and blood on the cuff', 'Airway leak']","[{'cui': 'C1720436', 'cui_str': 'Anesthetized'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0522224', 'cui_str': 'Plegia'}]","[{'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}, {'cui': 'C0439658', 'cui_str': 'Classic (qualifier value)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C0518766'}, {'cui': 'C1143776', 'cui_str': 'cobalt(II) bis(2,2,6,6-tetramethylheptane-3,5-dionate)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0242429', 'cui_str': 'Sore Throat'}, {'cui': 'C0005768'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0332234', 'cui_str': 'Leaking (qualifier value)'}]",64.0,0.0511537,"There was no significant difference between both groups regarding postoperative complications (cough, sore throat, and blood on the cuff) (P > 0.05).","[{'ForeName': 'Seyed Mohammad', 'Initials': 'SM', 'LastName': 'Reza Hashemian', 'Affiliation': 'Clinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Navid', 'Initials': 'N', 'LastName': 'Nouraei', 'Affiliation': 'Anesthesiology Research Center, National Research Institute of Tuberculosis and Lung Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Sadjad', 'Initials': 'SS', 'LastName': 'Razavi', 'Affiliation': 'Anesthesiology Research Center, National Research Institute of Tuberculosis and Lung Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Zaker', 'Affiliation': 'Anesthesiology Research Center, National Research Institute of Tuberculosis and Lung Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Jafari', 'Affiliation': 'Anesthesiology Research Center, National Research Institute of Tuberculosis and Lung Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Parivash', 'Initials': 'P', 'LastName': 'Eftekhari', 'Affiliation': 'Chronic Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Golnar', 'Initials': 'G', 'LastName': 'Radmand', 'Affiliation': 'Chronic Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Amir', 'Initials': 'SA', 'LastName': 'Mohajerani', 'Affiliation': 'Chronic Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Badiozzaman', 'Initials': 'B', 'LastName': 'Radpay', 'Affiliation': 'Anesthesiology Research Center, National Research Institute of Tuberculosis and Lung Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",International journal of critical illness and injury science,['10.4103/2229-5151.147520']
1702,25625062,"Comparison of endotracheal intubation, combitube, and laryngeal mask airway between inexperienced and experienced emergency medical staff: A manikin study.","BACKGROUND


Emergency Medical Service (EMS) personnel manage the airway, but only a group of them are allowed to engage in Endotracheal Intubation (ETI). Our purpose was to evaluate if the use of laryngeal mask airway (LMA) or Combitube can be used by inexperienced care providers.
MATERIALS AND METHODS


A randomized, prospective manikin study was conducted. Fifty-nine participants were randomly assigned into two groups. Experienced group included 16 paramedics, eight anesthetic-technicians, and inexperienced group included 27 Emergency Medical Technician-Basic (EMT-B) and eight nurses. Our main outcomes were success rate and time to airway after only one attempt.
RESULTS


Airway success was 73% for ETI, 98.3% for LMA, and 100% for Combitube. LMA and Combitube were faster and had greater success than ETI (P = 0.0001). Inexperienced had no differences in time to securing LMA compared with experienced (6.05 vs. 5.4 seconds, respectively, P = 0.26). One failure in inexperienced, and no failure in experienced group occurred to secure the LMA (P = 0.59). The median time to Combitube placement in experienced and inexperienced was 5.05 vs. 5.00 seconds, P = 0.65, respectively. Inexperienced and experienced groups performed ETI in 19.15 and 17 seconds, respectively (P = 0.001). After the trial, 78% preferred Combitube, 15.3% LMA, and 6.8% ETI as the device of choice in prehospital setting.
CONCLUSION


Time to airway was decreased and success rate increased significantly with the use of LMA and combitube compared with ETI, regardless of the experience level. This study suggests that both Combitube and LMA may be acceptable choices for management of airway in the prehospital setting for experienced and especially inexperienced EMS personnel.",2014,"Inexperienced and experienced groups performed ETI in 19.15 and 17 seconds, respectively (P = 0.001).","['Experienced group included 16 paramedics, eight anesthetic-technicians, and inexperienced group included 27 Emergency Medical Technician-Basic (EMT-B) and eight nurses', 'Fifty-nine participants']","['laryngeal mask airway (LMA) or Combitube', 'endotracheal intubation, combitube, and laryngeal mask airway between inexperienced and experienced emergency medical staff', 'Combitube and LMA']","['Airway success', 'success rate', 'time to securing LMA', 'median time to Combitube placement', 'success rate and time to airway']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030450', 'cui_str': 'Paramedics'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0013963', 'cui_str': 'Emergency Medicine Technicians'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}]","[{'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0025106', 'cui_str': 'Medical Staff'}]","[{'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]",59.0,0.0479125,"Inexperienced and experienced groups performed ETI in 19.15 and 17 seconds, respectively (P = 0.001).","[{'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Saeedi', 'Affiliation': 'Department of Emergency, Tehran University of Medical Sciences, Tehran, Iran ; Department of Emergency Medicine, Pre-Hospital Emergency Research Center, Shariati Hospital, Tehran Univeristy of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Houman', 'Initials': 'H', 'LastName': 'Hajiseyedjavadi', 'Affiliation': 'Department of Emergency, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Seyedhosseini', 'Affiliation': 'Department of Emergency, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Eslami', 'Affiliation': 'Department of Emergency, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hojat', 'Initials': 'H', 'LastName': 'Sheikhmotaharvahedi', 'Affiliation': 'Department of Emergency, Tehran University of Medical Sciences, Tehran, Iran.'}]",International journal of critical illness and injury science,['10.4103/2229-5151.147533']
1703,25613105,Gender-based Outcomes and Acceptability of a Computer-assisted Psychosocial Intervention for Substance Use Disorders.,"BACKGROUND


Digital technologies show promise for increasing treatment accessibility and improving quality of care, but little is known about gender differences. This secondary analysis uses data from a multi-site effectiveness trial of a computer-assisted behavioral intervention, conducted within NIDA's National Drug Abuse Clinical Trials Network, to explore gender differences in intervention acceptability and treatment outcomes.
METHODS


Men (n=314) and women (n=192) were randomly assigned to 12-weeks of treatment-as-usual (TAU) or modified TAU+Therapeutic Education System (TES), whereby TES substituted for 2hours of TAU per week. TES is composed of 62 Web-delivered, multimedia modules, covering skills for achieving and maintaining abstinence plus prize-based incentives contingent on abstinence and treatment adherence. Outcomes were: (1) abstinence from drugs and heavy drinking in the last 4weeks of treatment, (2) retention, (3) social functioning, and (4) drug and alcohol craving. Acceptability was the mean score across five indicators (i.e., interesting, useful, novel, easy to understand, and satisfaction).
RESULTS


Gender did not moderate the effect of treatment on any outcome. Women reported higher acceptability scores at week 4 (p=.02), but no gender differences were detected at weeks 8 or 12. Acceptability was positively associated with abstinence, but only among women (p=.01).
CONCLUSIONS


Findings suggest that men and women derive similar benefits from participating in a computer-assisted intervention, a promising outcome as technology-based treatments expand. Acceptability was associated with abstinence outcomes among women. Future research should explore characteristics of women who report less satisfaction with this modality of treatment and ways to improve overall acceptability.",2015,"Women reported higher acceptability scores at week 4 (p=.02), but no gender differences were detected at weeks 8 or 12.",['Men (n=314) and women (n=192'],"['TES', 'Computer-assisted Psychosocial Intervention', 'treatment-as-usual (TAU) or modified TAU+Therapeutic Education System (TES), whereby TES substituted for 2hours of TAU per week', 'computer-assisted behavioral intervention']","['acceptability scores', 'Acceptability', 'abstinence from drugs and heavy drinking in the last 4weeks of treatment, (2) retention, (3) social functioning, and (4) drug and alcohol craving']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}]",,0.163251,"Women reported higher acceptability scores at week 4 (p=.02), but no gender differences were detected at weeks 8 or 12.","[{'ForeName': 'Aimee N C', 'Initials': 'AN', 'LastName': 'Campbell', 'Affiliation': ""Columbia University Department of Psychiatry New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY 10032, USA; Mount Sinai St. Luke's Hospital Department of Psychiatry and Behavioral Health, 1111 Amsterdam Ave, New York, NY 10025, USA. Electronic address: anc2002@columbia.edu.""}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'Columbia University Department of Psychiatry New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY 10032, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': 'Columbia University Mailman School of Public Health Department of Biostatistics, 722 West 168th Street, 6th Floor, New York, NY 10032, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Hatch-Maillette', 'Affiliation': 'University of Washington Department of Psychiatry and Behavioral Sciences and Alcohol and Drug Abuse Institute, 1107 NE 45th Street, Suite 120, Box 354805, Seattle, WA 98105, USA.'}, {'ForeName': 'Mei-Chen', 'Initials': 'MC', 'LastName': 'Hu', 'Affiliation': 'Columbia University Medical Center, Department of Psychiatry, 630 West 168th Street, New York, NY 10032, USA.'}, {'ForeName': 'Genie L', 'Initials': 'GL', 'LastName': 'Bailey', 'Affiliation': 'Stanley Street Treatment and Research Center and Brown University Alpert Medical School, 386 Stanley St, Fall River, MA 02720, USA.'}, {'ForeName': 'Dawn E', 'Initials': 'DE', 'LastName': 'Sugarman', 'Affiliation': 'Harvard Medical School, Department of Psychiatry and McLean Hospital Division of Alcohol and Drug Abuse, 115 Mill Street, Belmont, MA 02478, USA.'}, {'ForeName': 'Gloria M', 'Initials': 'GM', 'LastName': 'Miele', 'Affiliation': 'Columbia University Department of Psychiatry New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY 10032, USA.'}, {'ForeName': 'Traci', 'Initials': 'T', 'LastName': 'Rieckmann', 'Affiliation': 'Oregon Health and Science University School of Medicine, 3181S.W. Sam Jackson Park Rd., Portland, OR 97239, USA.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Shores-Wilson', 'Affiliation': 'University of Texas Southwestern Medical Center Department of Psychiatry, 5323 Harry Hines Blvd., Dallas, TX 75390, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Turrigiano', 'Affiliation': 'Columbia University Department of Psychiatry New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY 10032, USA.'}, {'ForeName': 'Shelly F', 'Initials': 'SF', 'LastName': 'Greenfield', 'Affiliation': 'Harvard Medical School, Department of Psychiatry and McLean Hospital Division of Alcohol and Drug Abuse, 115 Mill Street, Belmont, MA 02478, USA.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2014.12.006']
1704,32424726,"Influence of lower body compression garments on cardiovascular autonomic responses prior to, during and following submaximal cycling exercise.","PURPOSE


The aim of the current study was to examine the impact of lower body compression garments (CG) on cardiac autonomic control of heart rate (HR) prior to, during and following submaximal exercise.
METHODS


Thirty (15 males, 15 females) healthy, active adults undertook consecutive 10-min stages of supine rest, moderate-intensity upright cycling and supine recovery while wearing either normal clothing (CONTROL) or normal clothing plus CG tights in a randomised order. Heart rate (HR) and rating of perceived exertion (RPE) were assessed every minute while cardiovascular autonomic responses were assessed during the final 5 min of each stage via HR variability (HRV). The change in HR at 1-min (HRR1) and 2-min (HRR2) post-exercise and the time constant of HR recovery (HR tau ) were assessed as indices of cardiac autonomic reactivation. Differences between variables were assessed via repeated measures ANOVA and corrected pairwise comparisons.
RESULTS


Compared to rest, exercise resulted in a reduction of HRV that was similar for CONTROL and CG. A main effect for condition was identified for one non-linear, long-term HRV variable only with a significantly lower value (61.4 ± 47.8 vs. 67.1 ± 50.2 ms, p < 0.05) for CG compared to CONTROL. Cardiac autonomic reactivation (HRR1, 42.0 ± 16.8 vs. 45.5 ± 13.4 bpm; HRR2, 58.9 ± 10.5 vs. 58.9 ± 8.2 bpm; HR tau , 63.4 ± 22.3 vs. 65.1 ± 23.0 s, p > 0.05) was comparable for CONTROL and CG.
CONCLUSION


Lower body CG failed to alter most cardiac autonomic responses during rest, moderate-intensity exercise or recovery. Mechanisms for potential ergogenic benefits of CG remain to be characterised.",2020,"HR tau , 63.4 ± 22.3 vs. 65.1 ± 23.0 s, p > 0.05) was comparable for CONTROL and CG.
","['Thirty (15 males, 15 females) healthy, active adults undertook consecutive 10-min stages of']","['supine rest, moderate-intensity upright cycling and supine recovery while wearing either normal clothing (CONTROL) or normal clothing plus CG tights', 'lower body compression garments (CG', 'lower body compression garments']","['cardiac autonomic control of heart rate (HR', 'Heart rate (HR) and rating of perceived exertion (RPE', 'cardiac autonomic responses', 'Cardiac autonomic reactivation', 'cardiovascular autonomic responses', 'cardiac autonomic reactivation', 'change in HR at 1-min (HRR1) and 2-min (HRR2) post-exercise and the time constant of HR recovery (HR tau ']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0009072', 'cui_str': 'Garments'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2985539', 'cui_str': 'Compression garment'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}]",,0.0622575,"HR tau , 63.4 ± 22.3 vs. 65.1 ± 23.0 s, p > 0.05) was comparable for CONTROL and CG.
","[{'ForeName': 'Anthony S', 'Initials': 'AS', 'LastName': 'Leicht', 'Affiliation': 'Sport and Exercise Science, James Cook University, Townsville, QLD, 4811, Australia. Anthony.Leicht@jcu.edu.au.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Ahmadian', 'Affiliation': 'School of Kinesiology, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Fabio Y', 'Initials': 'FY', 'LastName': 'Nakamura', 'Affiliation': 'Associate Graduate Program in Physical Education UPE/UFPB, João Pessoa, PB, Brazil.'}]",European journal of applied physiology,['10.1007/s00421-020-04391-9']
1705,25571960,Selenium status in U.K. pregnant women and its relationship with hypertensive conditions of pregnancy.,"Dietary intake/status of the trace mineral Se may affect the risk of developing hypertensive conditions of pregnancy, i.e. pre-eclampsia and pregnancy-induced hypertension (PE/PIH). In the present study, we evaluated Se status in U.K. pregnant women to establish whether pre-pregnant Se status or Se supplementation affected the risk of developing PE/PIH. The samples originated from the SPRINT (Selenium in PRegnancy INTervention) study that randomised 230 U.K. primiparous women to treatment with Se (60 μg/d) or placebo from 12 weeks of gestation. Whole-blood Se concentration was measured at 12 and 35 weeks, toenail Se concentration at 16 weeks, plasma selenoprotein P (SEPP1) concentration at 35 weeks and plasma glutathione peroxidase (GPx3) activity at 12, 20 and 35 weeks. Demographic data were collected at baseline. Participants completed a FFQ. U.K. pregnant women had whole-blood Se concentration lower than the mid-range of other populations, toenail Se concentration considerably lower than U.S. women, GPx3 activity considerably lower than U.S. and Australian pregnant women, and low baseline SEPP1 concentration (median 3.00, range 0.90-5.80 mg/l). Maternal age, education and social class were positively associated with Se status. After adjustment, whole-blood Se concentration was higher in women consuming Brazil nuts (P= 0.040) and in those consuming more than two seafood portions per week (P= 0.054). A stepwise logistic regression model revealed that among the Se-related risk factors, only toenail Se (OR 0.38, 95% CI 0.17, 0.87, P= 0.021) significantly affected the OR for PE/PIH. On excluding non-compliers with Se treatment, Se supplementation also significantly reduced the OR for PE/PIH (OR 0.30, 95% CI 0.09, 1.00, P= 0.049). In conclusion, U.K. women have low Se status that increases their risk of developing PE/PIH. Therefore, U.K. women of childbearing age need to improve their Se status.",2015,"After adjustment, whole-blood Se concentration was higher in women consuming Brazil nuts (P= 0.040) and in those consuming more than two seafood portions per week (P= 0.054).","['pregnant women', 'U.K. pregnant women and its relationship with hypertensive conditions of pregnancy', 'primiparous women to treatment with Se (60 μg/d) or']","['SPRINT (Selenium', 'placebo', 'trace mineral']","['plasma glutathione peroxidase (GPx3) activity', 'whole-blood Se concentration', 'low baseline SEPP1 concentration', 'GPx3 activity', 'Maternal age, education and social class', 'Whole-blood Se concentration', 'toenail Se concentration', 'OR for PE/PIH', 'plasma selenoprotein P (SEPP1) concentration']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0033150', 'cui_str': 'Primiparity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2145047', 'cui_str': 'Trace Minerals'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0017822', 'cui_str': 'Glutathione:hydrogen-peroxide oxidoreductase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0370231', 'cui_str': 'Whole blood (substance)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0024915', 'cui_str': 'Maternal Age'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0037402', 'cui_str': 'Social Class'}, {'cui': 'C0222007', 'cui_str': 'Toenails'}, {'cui': 'C0141947', 'cui_str': 'Selenoprotein P'}]",,0.0381737,"After adjustment, whole-blood Se concentration was higher in women consuming Brazil nuts (P= 0.040) and in those consuming more than two seafood portions per week (P= 0.054).","[{'ForeName': 'Margaret P', 'Initials': 'MP', 'LastName': 'Rayman', 'Affiliation': 'Department of Nutritional Sciences,Faculty of Health and Medical Sciences, School of Biosciences and Medicine, University of Surrey,GuildfordGU2 7XH,UK.'}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Bath', 'Affiliation': 'Department of Nutritional Sciences,Faculty of Health and Medical Sciences, School of Biosciences and Medicine, University of Surrey,GuildfordGU2 7XH,UK.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Westaway', 'Affiliation': 'School of Medical Science, Griffith Health Institute, Griffith University,Queensland,QLD4222,Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Williams', 'Affiliation': 'Department of Mathematics,Faculty of Engineering and Physical Sciences, University of Surrey,GuildfordGU2 7XH,UK.'}, {'ForeName': 'Jinyuan', 'Initials': 'J', 'LastName': 'Mao', 'Affiliation': 'Department of Nutritional Sciences,Faculty of Health and Medical Sciences, School of Biosciences and Medicine, University of Surrey,GuildfordGU2 7XH,UK.'}, {'ForeName': 'Jessica J', 'Initials': 'JJ', 'LastName': 'Vanderlelie', 'Affiliation': 'School of Medical Science, Griffith Health Institute, Griffith University,Queensland,QLD4222,Australia.'}, {'ForeName': 'Anthony V', 'Initials': 'AV', 'LastName': 'Perkins', 'Affiliation': 'School of Medical Science, Griffith Health Institute, Griffith University,Queensland,QLD4222,Australia.'}, {'ForeName': 'Christopher W G', 'Initials': 'CW', 'LastName': 'Redman', 'Affiliation': 'Nuffield Department of Obstetrics and Gynaecology, University of Oxford,OxfordOX3 9DU,UK.'}]",The British journal of nutrition,['10.1017/S000711451400364X']
1706,25421470,Population pharmacokinetics of micafungin and its metabolites M1 and M5 in children and adolescents.,"The aim of this analysis was to identify therapeutic micafungin regimens for children that produce the same micafungin exposures known to be effective for the prevention and treatment of Candida infections in adults. Pediatric pharmacokinetic data from 229 patients between the ages of 4 months and <17 years were obtained from four phase I and two phase III clinical trials. Population pharmacokinetic models were used to simulate the proportion of children who had a steady-state area under the concentration-time curve at 24 hours (AUC24) of micafungin within the 10th to 90th percentile range observed in a population of adults receiving a dose of micafungin with established efficacy for invasive candidiasis (100 mg/day), i.e., 75 to 139 μg·h/ml. Simulated pediatric dosages of 0.5 to 5 mg/kg of body weight/day were explored. A two-compartment model was used that incorporated body weight as a predefined covariate for allometric scaling of the pharmacokinetic parameters. During construction of the model, aspartate aminotransferase and total bilirubin were also identified as covariates that had a significant effect on micafungin clearance. A dose of 2 mg/kg resulted in the highest proportion of children within the predefined micafungin AUC24 target range for invasive candidiasis. Cutoffs of 40 or 50 kg for weight-based dosing resulted in heavier children being appropriately dosed. Thus, dose regimens of 1, 2, and 3 mg/kg/day micafungin are appropriate for the prevention of invasive candidiasis, the treatment of invasive candidiasis, and the treatment of esophageal candidiasis, respectively, in children aged 4 months to <17 years.",2015,A dose of 2 mg/kg resulted in the highest proportion of children within the predefined micafungin AUC24 target range for invasive candidiasis.,"['children who had a steady-state area under the concentration-time curve at 24 hours (AUC24) of micafungin within the 10th to 90th percentile range observed in a population of adults receiving a dose of micafungin with established efficacy for invasive candidiasis (100 mg/day), i.e., 75 to 139 μg·h/ml', 'children and adolescents', 'children aged 4 months to <17 years', 'adults', '229 patients between the ages of 4 months and <17 years were obtained from four phase']",[],"['aspartate aminotransferase and total bilirubin', 'micafungin clearance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C1120386', 'cui_str': 'micafungin'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]",[],"[{'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0201913', 'cui_str': 'Bilirubin, total measurement (procedure)'}, {'cui': 'C1120386', 'cui_str': 'micafungin'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}]",229.0,0.0417469,A dose of 2 mg/kg resulted in the highest proportion of children within the predefined micafungin AUC24 target range for invasive candidiasis.,"[{'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Hope', 'Affiliation': 'Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, United Kingdom william.hope@liverpool.ac.uk.'}, {'ForeName': 'Atsunori', 'Initials': 'A', 'LastName': 'Kaibara', 'Affiliation': 'Astellas Pharma, Northbrook, Illinois, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Roy', 'Affiliation': 'Astellas Pharma, Northbrook, Illinois, USA.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Arrieta', 'Affiliation': ""Children's Hospital of Orange County, Division of Infectious Disease, Orange, California, USA.""}, {'ForeName': 'Nkechi', 'Initials': 'N', 'LastName': 'Azie', 'Affiliation': 'Astellas Pharma, Northbrook, Illinois, USA.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Kovanda', 'Affiliation': 'Astellas Pharma, Northbrook, Illinois, USA.'}, {'ForeName': 'Daniel K', 'Initials': 'DK', 'LastName': 'Benjamin', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.03736-14']
1707,31888944,"Exploring the experiences of people in Ontario, Canada who have trouble affording medicines: a qualitative concept mapping study.","OBJECTIVES


The experiences of people who report cost-related medicine non-adherence are not well documented. We aimed to present experiences relating to accessing medicines reported by the participants in a randomised controlled trial of free medicine distribution.
METHODS


The trial consisted of primary care patients from a large urban family practice and three rural family practices who reported cost-related medicine non-adherence. Participants were randomly allocated to continue their poor access (control) or to receive free and easily accessible medicines (intervention). As part of data collection for the first year of the trial, participants were asked closed and open-ended questions to assess their adherence to medication, health outcomes and their experiences in relation to medicine accessibility. We conducted a qualitative concept mapping study in which we analysed and summarised participants' responses to the open-ended question on a concept map to visually present their experiences relating to accessing medicines.
RESULTS


Of the 524 trial participants contacted, 198 (38%) responded to the open-ended question. The concept map contains clusters that represent eight types of experiences of participants related to medicine access including stress, relationship with doctor, health impact, quality of life, sacrificing other essentials, medicines are expensive, financial impact and adherence. These experiences fall under two major themes, experiences relating to personal finances and experiences relating to well-being, which are bridged by a central cluster of adherence.
CONCLUSIONS


The experiences shared by the participants demonstrate that access to medicines impacts people's finances and well-being as well as their adherence to prescribed medicines. These results indicate that effects on personal finances and general well-being should be measured for interventions and policy changes aimed at improving medicine access.
TRIAL REGISTRATION NUMBER


This article is linked to the Carefully Selected and Easily Accessible at No Charge Medicines (CLEAN Meds) randomised controlled trial (trial registration number: NCT02744963).",2019,Participants were randomly allocated to continue their poor access (control) or to receive free and easily accessible medicines (intervention).,"['experiences of people in Ontario, Canada who have trouble affording medicines', 'Of the 524 trial participants contacted, 198 (38%) responded to the open-ended question', 'primary care patients from a large urban family practice and three rural family practices who reported cost-related medicine non-adherence']",['continue their poor access (control) or to receive free and easily accessible medicines (intervention'],[],"[{'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0015607', 'cui_str': 'Family Practice'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0457432', 'cui_str': 'Non-compliant (qualifier value)'}]","[{'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]",[],,0.0920864,Participants were randomly allocated to continue their poor access (control) or to receive free and easily accessible medicines (intervention).,"[{'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Yaphe', 'Affiliation': ""MAP Centre for Urban Health Solutions, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Itunuoluwa', 'Initials': 'I', 'LastName': 'Adekoya', 'Affiliation': ""MAP Centre for Urban Health Solutions, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Liane', 'Initials': 'L', 'LastName': 'Steiner', 'Affiliation': ""MAP Centre for Urban Health Solutions, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Darshanand', 'Initials': 'D', 'LastName': 'Maraj', 'Affiliation': ""MAP Centre for Urban Health Solutions, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': ""O'Campo"", 'Affiliation': ""MAP Centre for Urban Health Solutions, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Nav', 'Initials': 'N', 'LastName': 'Persaud', 'Affiliation': ""MAP Centre for Urban Health Solutions, St. Michael's Hospital, Toronto, Ontario, Canada nav.persaud@utoronto.ca.""}]",BMJ open,['10.1136/bmjopen-2019-033933']
1708,32425222,Repurposing chlorpromazine to treat COVID-19: The reCoVery study.,"OBJECTIVES


The ongoing COVID-19 pandemic has caused approximately 2,350,000 infections worldwide and killed more than 160,000 individuals. In Sainte-Anne Hospital (GHU PARIS Psychiatrie & Neuroscience, Paris, France) we have observed a lower incidence of symptomatic forms of COVID-19 among patients than among our clinical staff. This observation led us to hypothesize that psychotropic drugs could have a prophylactic action against SARS-CoV-2 and protect patients from the symptomatic and virulent forms of this infection, since several of these psychotropic drugs have documented antiviral properties. Chlorpromazine (CPZ), a phenothiazine derivative, is also known for its antiviral activity via the inhibition of clathrin-mediated endocytosis. Recentin vitro studies have reported that CPZ exhibits anti-MERS-CoV and anti-SARS-CoV-1 activity.
METHODS


In this context, the ReCoVery study aims to repurpose CPZ, a molecule with an excellent tolerance profile and a very high biodistribution in the saliva, lungs and brain. We hypothesize that CPZ could reduce the unfavorable course of COVID-19 infection among patients requiring respiratory support without the need for ICU care, and that it could also reduce the contagiousness of SARS-CoV-2. For this purpose, we plan a pilot, multicenter, randomized, single blind, controlled, phase III therapeutic trial (standard treatment vs. CPZ+standard treatment).
CONCLUSION


This repurposing of CPZ for its anti-SARS-CoV-2 activity could offer an alternative, rapid strategy to alleviate infection severity. This repurposing strategy also avoids numerous developmental and experimental steps, and could save precious time to rapidly establish an anti-COVID-19 therapy with well-known, limited and easily managed side effects.",2020,"This observation led us to hypothesize that psychotropic drugs could have a prophylactic action against SARS-CoV-2 and protect patients from the symptomatic and virulent forms of this infection, since several of these psychotropic drugs have documented antiviral properties.",[],"['Chlorpromazine (CPZ', 'chlorpromazine', 'phenothiazine derivative', 'CPZ', 'CPZ + standard treatment']",[],[],"[{'cui': 'C0008286', 'cui_str': 'Chlorpromazine'}, {'cui': 'C0304370', 'cui_str': 'Phenothiazine derivative'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],,0.0585347,"This observation led us to hypothesize that psychotropic drugs could have a prophylactic action against SARS-CoV-2 and protect patients from the symptomatic and virulent forms of this infection, since several of these psychotropic drugs have documented antiviral properties.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Plaze', 'Affiliation': 'GHU PARIS Psychiatrie & Neurosciences, site Sainte-Anne, Service Hospitalo-Universitaire, Pôle Hospitalo-Universitaire Paris 15, Paris, France; Université de Paris, Paris, France. Electronic address: m.plaze@ghu-paris.fr.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Attali', 'Affiliation': 'GHU PARIS Psychiatrie & Neurosciences, site Sainte-Anne, Service Hospitalo-Universitaire, Pôle Hospitalo-Universitaire Paris 15, Paris, France; Université de Paris, Paris, France; Physics for Medicine Paris, Inserm, ESPCI Paris, CNRS, PSL Research University, Univ Paris Diderot, Sorbonne Paris Cite, Paris, France.'}, {'ForeName': 'A-C', 'Initials': 'AC', 'LastName': 'Petit', 'Affiliation': 'GHU PARIS Psychiatrie & Neurosciences, site Sainte-Anne, Service Hospitalo-Universitaire, Pôle Hospitalo-Universitaire Paris 15, Paris, France; Institut Pasteur, Experimental Neuropathology Unit, Paris, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Blatzer', 'Affiliation': 'Institut Pasteur, Experimental Neuropathology Unit, Paris, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Simon-Loriere', 'Affiliation': 'Institut Pasteur, G5 Evolutionary Genomics of RNA Viruses, Paris, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Vinckier', 'Affiliation': 'GHU PARIS Psychiatrie & Neurosciences, site Sainte-Anne, Service Hospitalo-Universitaire, Pôle Hospitalo-Universitaire Paris 15, Paris, France; Université de Paris, Paris, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cachia', 'Affiliation': ""Université de Paris, Institut de Psychiatrie et Neurosciences de Paris, INSERM, Paris, France; Université de Paris, Laboratoire de Psychologie du développement et de l'Éducation de l'Enfant, CNRS, Paris, France.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Chrétien', 'Affiliation': 'Institut Pasteur, Experimental Neuropathology Unit, Paris, France; GHU PARIS Psychiatrie & Neurosciences, site Sainte-Anne, Service de Neuropathologie, Paris, France.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gaillard', 'Affiliation': 'GHU PARIS Psychiatrie & Neurosciences, site Sainte-Anne, Service Hospitalo-Universitaire, Pôle Hospitalo-Universitaire Paris 15, Paris, France; Université de Paris, Paris, France; Institut Pasteur, Experimental Neuropathology Unit, Paris, France.'}]",L'Encephale,['10.1016/j.encep.2020.05.006']
1709,24708917,"Effect of selenium on markers of risk of pre-eclampsia in UK pregnant women: a randomised, controlled pilot trial.","Pre-eclampsia is a serious hypertensive condition of pregnancy associated with high maternal and fetal morbidity and mortality. Se intake or status has been linked to the occurrence of pre-eclampsia by our own work and that of others. We hypothesised that a small increase in the Se intake of UK pregnant women of inadequate Se status would protect against the risk of pre-eclampsia, as assessed by biomarkers of pre-eclampsia. In a double-blind, placebo-controlled, pilot trial, we randomised 230 primiparous pregnant women to Se (60 μg/d, as Se-enriched yeast) or placebo treatment from 12 to 14 weeks of gestation until delivery. Whole-blood Se concentration was measured at baseline and 35 weeks, and plasma selenoprotein P (SEPP1) concentration at 35 weeks. The primary outcome measure of the present study was serum soluble vascular endothelial growth factor receptor-1 (sFlt-1), an anti-angiogenic factor linked with the risk of pre-eclampsia. Other serum/plasma components related to the risk of pre-eclampsia were also measured. Between 12 and 35 weeks, whole-blood Se concentration increased significantly in the Se-treated group but decreased significantly in the placebo group. At 35 weeks, significantly higher concentrations of whole-blood Se and plasma SEPP1 were observed in the Se-treated group than in the placebo group. In line with our hypothesis, the concentration of sFlt-1 was significantly lower at 35 weeks in the Se-treated group than in the placebo group in participants in the lowest quartile of Se status at baseline (P= 0·039). None of the secondary outcome measures was significantly affected by treatment. The present finding that Se supplementation has the potential to reduce the risk of pre-eclampsia in pregnant women of low Se status needs to be validated in an adequately powered trial.",2014,"Between 12 and 35 weeks, whole-blood Se concentration increased significantly in the Se-treated group but decreased significantly in the placebo group.","['UK pregnant women', '230 primiparous pregnant women to Se (60 μg']","['placebo', 'selenium']","['whole-blood Se concentration', 'concentrations of whole-blood Se and plasma SEPP1', 'markers of risk of pre-eclampsia', 'concentration of sFlt-1', 'Whole-blood Se concentration', 'serum soluble vascular endothelial growth factor receptor-1 (sFlt-1), an anti-angiogenic factor linked with the risk of pre-eclampsia', 'plasma selenoprotein P (SEPP1) concentration']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0033150', 'cui_str': 'Primiparity'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}]","[{'cui': 'C0370231', 'cui_str': 'Whole blood (substance)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C1313526', 'cui_str': 'S2FLT'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0378516', 'cui_str': 'fms-Like Tyrosine Kinase'}, {'cui': 'C0002976', 'cui_str': 'Angiogenesis Factor'}, {'cui': 'C0141947', 'cui_str': 'Selenoprotein P'}]",230.0,0.194338,"Between 12 and 35 weeks, whole-blood Se concentration increased significantly in the Se-treated group but decreased significantly in the placebo group.","[{'ForeName': 'Margaret P', 'Initials': 'MP', 'LastName': 'Rayman', 'Affiliation': 'Department of Nutritional Sciences,School of Biosciences and Medicine, Faculty of Health and Medical Sciences, University of Surrey,GuildfordGU2 7XH,UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Searle', 'Affiliation': 'Nuffield Department of Obstetrics and Gynaecology, University of Oxford,OxfordOX3 9DU,UK.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Kelly', 'Affiliation': 'Anu Research Centre, Department of Obstetrics and Gynaecology, Cork University Maternity Hospital,Wilton, Cork,Republic of Ireland.'}, {'ForeName': 'Sigurd', 'Initials': 'S', 'LastName': 'Johnsen', 'Affiliation': 'Surrey Clinical Research Centre (CRC), Faculty of Health and Medical Sciences, University of Surrey,GuildfordGU2 7XP,UK.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Bodman-Smith', 'Affiliation': 'Department of Nutritional Sciences,School of Biosciences and Medicine, Faculty of Health and Medical Sciences, University of Surrey,GuildfordGU2 7XH,UK.'}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Bath', 'Affiliation': 'Department of Nutritional Sciences,School of Biosciences and Medicine, Faculty of Health and Medical Sciences, University of Surrey,GuildfordGU2 7XH,UK.'}, {'ForeName': 'Jinyuan', 'Initials': 'J', 'LastName': 'Mao', 'Affiliation': 'Department of Nutritional Sciences,School of Biosciences and Medicine, Faculty of Health and Medical Sciences, University of Surrey,GuildfordGU2 7XH,UK.'}, {'ForeName': 'Christopher W G', 'Initials': 'CW', 'LastName': 'Redman', 'Affiliation': 'Nuffield Department of Obstetrics and Gynaecology, University of Oxford,OxfordOX3 9DU,UK.'}]",The British journal of nutrition,['10.1017/S0007114514000531']
1710,31121100,Interindividual variability and individual responses to exercise training in adolescents with obesity.,"This study investigated the impact of exercise training on interindividual variability and response rates in body composition and cardiometabolic outcomes in adolescents with obesity. Postpubertal males and females ( n  = 143) were randomly assigned to 6 months of a diet-only control or aerobic, resistance, or combined exercise training. Body composition indices were percentages of body fat mass and lean body mass and waist circumference. Biomarkers of cardiometabolic health were systolic blood pressure and plasma fasting glucose, triglycerides, and high-density lipoprotein cholesterol. Interindividual variability was examined by comparing the standard deviation of individual responses (SD IR ) to a smallest robust change (SRC). The typical error of measurement was used to classify responses. SD IR  exceeded the SRC for percent body fat mass in all exercise groups (SRC = 1.04%; aerobic SD IR  = 1.50%; resistance SD IR  = 1.22%; combined SD IR  = 2.29%), percent lean body mass (SRC = 1.38%; SD IR  = 3.2%,), systolic blood pressure (SRC = 2.06 mm Hg; SD IR  = 4.92 mm Hg) in the resistance group, and waist circumference (SRC = 2.33 cm; SD IR  = 4.09 cm), and fasting glucose (SRC = 0.08 mmol/L; SD IR  = 0.28 mmol/L) in the combined group. However, half of the reported variables (11/21) did not have a positive SD IR . Importantly, adverse response rates were significantly lower in all 3 exercise groups compared with control for body composition. Although exercise had a small influence on interindividual variability for indices of body composition, the rate of adverse responses did not increase for any outcome.  Novelty  Interindividual variability and individual responses to exercise training have not been investigated in adolescents with obesity. Six months of exercise training does not increase interindividual variability in adolescents with obesity. Exercise created a positive, uniform shift in responses.",2020,"Importantly, adverse response rates were significantly lower in all three exercise groups than control for body composition.","['adolescents with obesity', 'Postpubertal males and females (n=143']","['exercise training', 'Six', 'diet-only Control or Aerobic, Resistance, or Combined exercise training']","['body fat mass (%BFM) and lean body mass (%LBM), and waist circumference (WC', 'BFM', 'Interindividual variability', 'fasting glucose', 'adverse response rates', 'systolic blood pressure (SBP) and plasma fasting glucose, triglycerides, and high-density lipoprotein cholesterol', 'SDIR', 'interindividual variability']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}]",143.0,0.0430517,"Importantly, adverse response rates were significantly lower in all three exercise groups than control for body composition.","[{'ForeName': 'Jeremy J', 'Initials': 'JJ', 'LastName': 'Walsh', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia Okanagan, Kelowna, BC V1V 1V7, Canada.'}, {'ForeName': 'Jacob T', 'Initials': 'JT', 'LastName': 'Bonafiglia', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, Kingston, ON K7L 3N6, Canada.""}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Goldfield', 'Affiliation': ""Healthy Active Living and Obesity Research Group, Children's Hospital of Eastern Ontario Research Institute, Ottawa, ON K1H 8L1, Canada.""}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Sigal', 'Affiliation': 'School of Human Kinetics, Faculty of Health Sciences, University of Ottawa, Ottawa, ON K1N 6N5, Canada.'}, {'ForeName': 'Glen P', 'Initials': 'GP', 'LastName': 'Kenny', 'Affiliation': 'School of Human Kinetics, Faculty of Health Sciences, University of Ottawa, Ottawa, ON K1N 6N5, Canada.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Doucette', 'Affiliation': 'Department of Community Health & Epidemiology, Dalhousie University, Halifax, NS B3H 4R2, Canada.'}, {'ForeName': 'Stasia', 'Initials': 'S', 'LastName': 'Hadjiyannakis', 'Affiliation': ""Centre for Healthy Active Living, Children's Hospital of Eastern Ontario Research Institute, Ottawa, ON K1H 8L1, Canada.""}, {'ForeName': 'Angela S', 'Initials': 'AS', 'LastName': 'Alberga', 'Affiliation': 'Department of Health, Kinesiology & Applied Physiology, Concordia University, Montreal, QC H4B 1R6, Canada.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': ""Prud'homme"", 'Affiliation': 'School of Human Kinetics, Faculty of Health Sciences, University of Ottawa, Ottawa, ON K1N 6N5, Canada.'}, {'ForeName': 'Brendon J', 'Initials': 'BJ', 'LastName': 'Gurd', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, Kingston, ON K7L 3N6, Canada.""}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0088']
1711,25337479,Comparison of the effect of intravenous ketamine and intramuscular ketamine for orthopedic procedures in children's sedation.,"BACKGROUND


Ketamine is used as a general anesthetic for short-term surgical procedures. The aim of this study is to compare the effect of intravenous (IV) ketamine and intramuscular (IM) ketamine in children admitted to the emergency department (ED).
MATERIALS AND METHODS


This is a clinical trial on 60 patients who were randomly classified into two groups. The first group received IV ketamine (1 mg/kg) and the second received IM ketamine (4 mg/kg). Data were collected before, during, and after the procedure. Time to reach sedation, severity of the sedation, and complications of the drug until discharge were studied.
RESULTS


In this study, 60 patients were evaluated. The average length of the procedures was similar in both groups (P > 0.05). According to this study, sedation levels in the two groups in 5, 10, and 15 minutes did not show significant differences (P > 0.05), but there was a significant difference in sedation levels of patients in 30, 35, 40, and 45 minutes during sedation (P = 0.03, P = 0.04, P = 0.03 and P = 0.05). There was no significant difference in the incidence of complications between the two groups.
DICUSSION


There was no significant difference in complications and level of sedation in both groups, but sedation was longer in the IM group; so, IV ketamine is the desirable approach for orthopedic procedures in sedating children.",2014,"There was no significant difference in complications and level of sedation in both groups, but sedation was longer in the IM group; so, IV ketamine is the desirable approach for orthopedic procedures in sedating children.","[""children's sedation"", '60 patients who were randomly classified into two groups', 'children admitted to the emergency department (ED', '60 patients were evaluated']","['intravenous (IV) ketamine and intramuscular (IM) ketamine', 'IV ketamine', 'ketamine and intramuscular ketamine', 'Ketamine', 'IM ketamine', 'ketamine']","['average length of the procedures', 'incidence of complications', 'sedation levels', 'complications and level of sedation', 'Time to reach sedation, severity of the sedation, and complications of the drug until discharge']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}]","[{'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]",60.0,0.033628,"There was no significant difference in complications and level of sedation in both groups, but sedation was longer in the IM group; so, IV ketamine is the desirable approach for orthopedic procedures in sedating children.","[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Momeni', 'Affiliation': 'Department of Emergency Medicine, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Esfandbod', 'Affiliation': 'Department of Emergency Medicine, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Saeedi', 'Affiliation': 'Department of Emergency Medicine, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohamadreza', 'Initials': 'M', 'LastName': 'Farnia', 'Affiliation': 'Department of Emergency Medicine, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Basirani', 'Affiliation': 'Department of Emergency Medicine, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Jeyran', 'Initials': 'J', 'LastName': 'Zebardast', 'Affiliation': 'Department of Emergency Medicine, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}]",International journal of critical illness and injury science,['10.4103/2229-5151.141352']
1712,25179587,"Achieving cannabis cessation -- evaluating N-acetylcysteine treatment (ACCENT): design and implementation of a multi-site, randomized controlled study in the National Institute on Drug Abuse Clinical Trials Network.","Despite recent advances in behavioral interventions for cannabis use disorders, effect sizes remain modest, and few individuals achieve long-term abstinence. One strategy to enhance outcomes is the addition of pharmacotherapy to complement behavioral treatment, but to date no efficacious medications targeting cannabis use disorders in adults through large, randomized controlled trials have been identified. The National Institute on Drug Abuse Clinical Trials Network (NIDA CTN) is currently conducting a study to test the efficacy of N-acetylcysteine (NAC) versus placebo (PBO), added to contingency management, for cannabis cessation in adults (ages 18-50). This study was designed to replicate positive findings from a study in cannabis-dependent adolescents that found greater odds of abstinence with NAC compared to PBO. This paper describes the design and implementation of an ongoing 12-week, intent-to-treat, double-blind, randomized, placebo-controlled study with one follow-up visit four weeks post-treatment. Approximately 300 treatment-seeking cannabis-dependent adults will be randomized to NAC or PBO across six study sites in the United States. The primary objective of this 12-week study is to evaluate the efficacy of twice-daily orally-administered NAC (1200 mg) versus matched PBO, added to contingency management, on cannabis abstinence. NAC is among the first medications to demonstrate increased odds of abstinence in a randomized controlled study among cannabis users in any age group. The current study will assess the cannabis cessation efficacy of NAC combined with a behavioral intervention in adults, providing a novel and timely contribution to the evidence base for the treatment of cannabis use disorders.",2014,NAC is among the first medications to demonstrate increased odds of abstinence in a randomized controlled study among cannabis users in any age group.,"['cannabis cessation in adults (ages 18-50', 'Approximately 300 treatment-seeking cannabis-dependent adults']","['placebo', 'N-acetylcysteine (NAC) versus placebo (PBO', 'NAC', 'NAC combined with a behavioral intervention', 'twice-daily orally-administered NAC', 'cannabis cessation -- evaluating N-acetylcysteine treatment (ACCENT']",[],"[{'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0947697', 'cui_str': 'Accent'}]",[],,0.133498,NAC is among the first medications to demonstrate increased odds of abstinence in a randomized controlled study among cannabis users in any age group.,"[{'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'McClure', 'Affiliation': 'Medical University of South Carolina College of Medicine, 67 President St., Charleston, SC 29425, United States. Electronic address: mccluree@musc.edu.'}, {'ForeName': 'Susan C', 'Initials': 'SC', 'LastName': 'Sonne', 'Affiliation': 'Medical University of South Carolina College of Medicine, 67 President St., Charleston, SC 29425, United States.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': 'Addiction Sciences Division, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, United States.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Carroll', 'Affiliation': 'Yale University School of Medicine, 950 Campbell Ave, West Haven, CT 06516, United States.'}, {'ForeName': 'Udi E', 'Initials': 'UE', 'LastName': 'Ghitza', 'Affiliation': 'Center for the Clinical Trials Network, National Institute on Drug Abuse, 6001 Executive Boulevard, MSC 9557, Bethesda, MD 20892, United States.'}, {'ForeName': 'Aimee L', 'Initials': 'AL', 'LastName': 'McRae-Clark', 'Affiliation': 'Medical University of South Carolina College of Medicine, 67 President St., Charleston, SC 29425, United States.'}, {'ForeName': 'Abigail G', 'Initials': 'AG', 'LastName': 'Matthews', 'Affiliation': 'The EMMES Corporation, 401 N. Washington St., Rockville, MD 20850, United States.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Sharma', 'Affiliation': 'The EMMES Corporation, 401 N. Washington St., Rockville, MD 20850, United States.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Van Veldhuisen', 'Affiliation': 'The EMMES Corporation, 401 N. Washington St., Rockville, MD 20850, United States.'}, {'ForeName': 'Ryan G', 'Initials': 'RG', 'LastName': 'Vandrey', 'Affiliation': 'Johns Hopkins University, School of Medicine, 5510 Nathan Shock Dr., Baltimore, MD 21224, United States.'}, {'ForeName': 'Frances R', 'Initials': 'FR', 'LastName': 'Levin', 'Affiliation': 'Columbia University/New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY 10032, United States.'}, {'ForeName': 'Roger D', 'Initials': 'RD', 'LastName': 'Weiss', 'Affiliation': 'Division of Alcohol and Drug Abuse, McLean Hospital, 115 Mill St., Belmont, MA 02478, United States; Department of Psychiatry, Harvard Medical School, 25 Shattuck St., Boston, MA 02115, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lindblad', 'Affiliation': 'The EMMES Corporation, 401 N. Washington St., Rockville, MD 20850, United States.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Allen', 'Affiliation': 'The EMMES Corporation, 401 N. Washington St., Rockville, MD 20850, United States.'}, {'ForeName': 'Larissa J', 'Initials': 'LJ', 'LastName': 'Mooney', 'Affiliation': 'University of California, Los Angeles, David Geffen School of Medicine, 1640 S. Sepulveda Blvd., Suite 120, Los Angeles, CA 90025, United States.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Haynes', 'Affiliation': 'Medical University of South Carolina College of Medicine, 67 President St., Charleston, SC 29425, United States.'}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Brigham', 'Affiliation': 'Addiction Sciences Division, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, United States.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Sparenborg', 'Affiliation': 'Center for the Clinical Trials Network, National Institute on Drug Abuse, 6001 Executive Boulevard, MSC 9557, Bethesda, MD 20892, United States.'}, {'ForeName': 'Albert L', 'Initials': 'AL', 'LastName': 'Hasson', 'Affiliation': 'University of California, Los Angeles, David Geffen School of Medicine, 1640 S. Sepulveda Blvd., Suite 120, Los Angeles, CA 90025, United States.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Gray', 'Affiliation': 'Medical University of South Carolina College of Medicine, 67 President St., Charleston, SC 29425, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2014.08.011']
1713,31915175,Effect of early palliative care for patients with glioblastoma (EPCOG): a randomised phase III clinical trial protocol.,"​INTRODUCTION: Randomised controlled trials (RCTs) have shown a positive effect of early integration of palliative care (EIPC) in various advanced cancer entities regarding patients' quality of life (QoL), survival, mood, caregiver burden and reduction of aggressiveness of treatment near the end of life. However, RCTs investigating the positive effect of EIPC for patients suffering from glioblastoma multiforme (GBM) are lacking. After modelling work identifying the specific needs of GBM patients and their caregivers, the aim of this study is to investigate the impact of EIPC in this particular patient group. ​METHODS AND ANALYSIS: The recruitment period of this multicenter RCT started in May 2019. GBM patients (n=214) and their caregivers will be randomly assigned to either the intervention group (receiving proactive EIPC on a monthly basis) or the control group (receiving treatment according to international standards and additional, regular assessment of QoL ('optimised' standard care)).The primary outcome is QoL assessed by subscales of the Functional Assessment of Cancer Therapy for brain tumour (FACT-Br) from baseline to 6 months of treatment. Secondary outcomes are changes in QoL after 12 (end of intervention), 18 and 24 months (end of follow-up), the full FACT-Br scale, patients' palliative care needs, depression/anxiety, cognitive impairment, caregiver burden, healthcare use, cost-effectiveness and overall survival. ​ETHICS AND DISSEMINATION: The study will be conducted in accordance with the Declaration of Helsinki and has been approved by the local ethics committees of the University Clinics of Cologne, Aachen, Bonn, Freiburg and Munich (LMU). Results of the trial will be submitted for publication in a peer-reviewed, open access journal and disseminated through presentations at conferences. TRIAL REGISTRATION NUMBER: German Register for Clinical Studies (DRKS) (DRKS00016066); Pre-results.",2020,"Randomised controlled trials (RCTs) have shown a positive effect of early integration of palliative care (EIPC) in various advanced cancer entities regarding patients' quality of life (QoL), survival, mood, caregiver burden and reduction of aggressiveness of treatment near the end of life.","['GBM patients (n=214) and their caregivers', 'patients with glioblastoma (EPCOG', 'patients suffering from glioblastoma multiforme (GBM']","['early palliative care', 'intervention group (receiving proactive EIPC', 'palliative care (EIPC', 'EIPC', ""control group (receiving treatment according to international standards and additional, regular assessment of QoL ('optimised' standard care)).The primary outcome is QoL assessed by subscales of the Functional Assessment of Cancer Therapy for brain tumour (FACT-Br""]","['changes in QoL', ""full FACT-Br scale, patients' palliative care needs, depression/anxiety, cognitive impairment, caregiver burden, healthcare use, cost-effectiveness and overall survival""]","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}, {'cui': 'C1621958', 'cui_str': 'Glioblastoma Multiforme'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0006118', 'cui_str': 'Brain Tumors'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0222045'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.183488,"Randomised controlled trials (RCTs) have shown a positive effect of early integration of palliative care (EIPC) in various advanced cancer entities regarding patients' quality of life (QoL), survival, mood, caregiver burden and reduction of aggressiveness of treatment near the end of life.","[{'ForeName': 'Heidrun', 'Initials': 'H', 'LastName': 'Golla', 'Affiliation': 'Department of Palliative Medicine, Faculty of Medicine and University Hospital, University of Cologne, Cologne, Germany heidrun.golla@uk-koeln.de.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Nettekoven', 'Affiliation': 'Department of Palliative Medicine, Faculty of Medicine and University Hospital, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Bausewein', 'Affiliation': 'Department of Palliative Medicine, Faculty of Medicine and University Hospital, University of Munich (LMU), Munich, Germany.'}, {'ForeName': 'Jörg-Christian', 'Initials': 'JC', 'LastName': 'Tonn', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine and University Hospital, University of Munich (LMU), Munich, Germany.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Thon', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine and University Hospital, University of Munich (LMU), Munich, Germany.'}, {'ForeName': 'Berend', 'Initials': 'B', 'LastName': 'Feddersen', 'Affiliation': 'Department of Palliative Medicine, Faculty of Medicine and University Hospital, University of Munich (LMU), Munich, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Schnell', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine and University Hospital, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Böhlke', 'Affiliation': 'Department of Palliative Medicine, Faculty of Medicine and University Hospital, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Gerhild', 'Initials': 'G', 'LastName': 'Becker', 'Affiliation': 'Department of Palliative Medicine, Faculty of Medicine and University Hospital, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Rolke', 'Affiliation': 'Department of Palliative Medicine, Faculty of Medicine and University Hospital, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Clusmann', 'Affiliation': 'Faculty of Medicine and University Hospital, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD), University of Cologne, Cologne, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Herrlinger', 'Affiliation': 'Division of Clinical Neurooncology, Department of Neurology, Faculty of Medicine and University Hospital, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Radbruch', 'Affiliation': 'Department of Palliative Medicine, Faculty of Medicine and University Hospital, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Vatter', 'Affiliation': 'Faculty of Medicine and University Hospital, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD), University of Cologne, Cologne, Germany.'}, {'ForeName': 'Erdem', 'Initials': 'E', 'LastName': 'Güresir', 'Affiliation': 'Faculty of Medicine and University Hospital, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD), University of Cologne, Cologne, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Stock', 'Affiliation': 'Faculty of Medicine and University Hospital, Institute for Health Economics and Clinical Epidemiology (IGKE), University of Cologne, Cologne, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Müller', 'Affiliation': 'Faculty of Medicine and University Hospital, Institute for Health Economics and Clinical Epidemiology (IGKE), University of Cologne, Cologne, Germany.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Civello', 'Affiliation': 'Faculty of Medicine and University Hospital, Institute for Health Economics and Clinical Epidemiology (IGKE), University of Cologne, Cologne, Germany.'}, {'ForeName': 'Irini', 'Initials': 'I', 'LastName': 'Papachristou', 'Affiliation': 'Faculty of Medicine and University Hospital, Center for Clinical Studies (ZKS), University of Cologne, Cologne, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hellmich', 'Affiliation': 'Faculty of Medicine and University Hospital, Institute of Medical Statistics and Computational Biology (IMSB), University of Cologne, Cologne, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Hamacher', 'Affiliation': 'Faculty of Medicine and University Hospital, Institute of Medical Statistics and Computational Biology (IMSB), University of Cologne, Cologne, Germany.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Voltz', 'Affiliation': 'Department of Palliative Medicine, Faculty of Medicine and University Hospital, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Goldbrunner', 'Affiliation': 'Department of General Neurosurgery, Faculty of Medicine and University Hospital, Center for Neurosurgery, University of Cologne, Cologne, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-034378']
1714,25396407,Effects of pistachio nut supplementation on blood glucose in patients with type 2 diabetes: a randomized crossover trial.,"BACKGROUND


Diabetes is a chronic, potentially debilitating, and often fatal disease. Dietary strategies to reduce postprandial glycemia are important in the prevention and treatment of diabetes. Nuts are rich in mono- and polyunsaturated fatty acids, which may reduce hyperglycemia and improve metabolism.
OBJECTIVES


To evaluate the effectiveness of pistachio nut supplementation on glycemic and inflammatory measures in patients with type 2 diabetes.
METHODS


In this double-blind, randomized, placebo-controlled, crossover trial, 48 diabetic patients were equally assigned to groups A and B. Patients in group A received a snack of 25 g pistachio nuts twice a day for 12 weeks and group B received a control meal without nuts. After 12 weeks of intervention, the patients had an 8-week washout. Then the groups were displaced, and group B received the same amount of pistachios for 12 weeks.
RESULTS


With respect to the total change in variables over both phases, there was a marked decrease in HbA1c (-0.4%) and fasting blood glucose (FBG) concentrations (-16 mg/dl) in the pistachio group compared with the control group (p ≤ 0.001 for both). There was no overall significant change in BMI, blood pressure, HOMA-IR, and C-reactive protein (CRP) concentrations. Analysis of the two phases separately showed a decrease in FBG by 14 mg/dl and in HbA1c by 0.45% in the treatment group (A) after 12 weeks, while no significant differences were seen in group B (control group). In the second phase, FBG decreased from 151.36 ± 39.22 to 137.28 ± 28.65 mg/dl (-14 mg/dl) and HbA1c decreased from 7.42 ± 0.97 to 7.15 ± 0.68 mg/dl (-0.28%, p = 0.013 and p = 0.033, respectively) in the pistachio group (B). Pistachio consumption reduced systolic blood pressure (p = 0.007), BMI (p = 0.011), and CRP (p = 0.002) in patients from the treatment groups, but not insulin resistance.
CONCLUSIONS


Dietary consumption of pistachio nuts as a snack has beneficial effects on glycemic control, blood pressure, obesity, and inflammation markers in diabetic patients.",2014,"Pistachio consumption reduced systolic blood pressure (p = 0.007), BMI (p = 0.011), and CRP (p = 0.002) in patients from the treatment groups, but not insulin resistance.
","['diabetic patients', '48 diabetic patients', 'patients with type 2 diabetes']","['control meal without nuts', 'snack of 25 g pistachio nuts', 'pistachio nut supplementation', 'placebo']","['glycemic and inflammatory measures', 'systolic blood pressure', 'postprandial glycemia', 'glycemic control, blood pressure, obesity, and inflammation markers', 'FBG', 'CRP', 'BMI', 'BMI, blood pressure, HOMA-IR, and C-reactive protein (CRP) concentrations', 'HbA1c', 'blood glucose', 'fasting blood glucose (FBG) concentrations']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C3494314', 'cui_str': 'Snacking'}, {'cui': 'C0456638', 'cui_str': '25G (qualifier value)'}, {'cui': 'C0459819', 'cui_str': 'Pistachio'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}]",48.0,0.0431267,"Pistachio consumption reduced systolic blood pressure (p = 0.007), BMI (p = 0.011), and CRP (p = 0.002) in patients from the treatment groups, but not insulin resistance.
","[{'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Parham', 'Affiliation': 'Clinical Research Development Center, Qom University of Medical Sciences, Qom, Iran.'}, {'ForeName': 'Saeide', 'Initials': 'S', 'LastName': 'Heidari', 'Affiliation': 'Faculty of Nursing and Midwifery, Qom University of Medical Sciences, Qom, Iran.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Khorramirad', 'Affiliation': 'Faculty of Nursing and Midwifery, Qom University of Medical Sciences, Qom, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Hozoori', 'Affiliation': 'Nutritional Research Center, Qom University of Medical Sciences, Qom, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Hosseinzadeh', 'Affiliation': 'Clinical Research Development Center, Qom University of Medical Sciences, Qom, Iran.'}, {'ForeName': 'Lida', 'Initials': 'L', 'LastName': 'Bakhtyari', 'Affiliation': 'Qom University of Medical Sciences, Qom, Iran.'}, {'ForeName': 'Jamshid', 'Initials': 'J', 'LastName': 'Vafaeimanesh', 'Affiliation': 'Clinical Research Development Center, Qom University of Medical Sciences, Qom, Iran.'}]",The review of diabetic studies : RDS,['10.1900/RDS.2014.11.190']
1715,25179753,Brief intervention for patients with problematic drug use presenting in emergency departments: a randomized clinical trial.,"IMPORTANCE


Medical treatment settings such as emergency departments (EDs) present important opportunities to address problematic substance use. Currently, EDs do not typically intervene beyond acute medical stabilization.
OBJECTIVE


To contrast the effects of a brief intervention with telephone boosters (BI-B) with those of screening, assessment, and referral to treatment (SAR) and minimal screening only (MSO) among drug-using ED patients.
DESIGN, SETTING, AND PARTICIPANTS


Between October 2010 and February 2012, 1285 adult ED patients from 6 US academic hospitals, who scored 3 or greater on the 10-item Drug Abuse Screening Test (indicating moderate to severe problems related to drug use) and who were currently using drugs, were randomized to MSO (n = 431), SAR (n = 427), or BI-B (n = 427). Follow-up assessments were conducted at 3, 6, and 12 months by blinded interviewers.
INTERVENTIONS


Following screening, MSO participants received only an informational pamphlet. The SAR participants received assessment plus referral to addiction treatment if indicated, and the BI-B participants received assessment and referral as in SAR, plus a manual-guided counseling session based on motivational interviewing principles and up to 2 ""booster"" sessions by telephone during the month following the ED visit.
MAIN OUTCOMES AND MEASURES


Outcomes evaluated at follow-up visits included self-reported days using the patient-defined primary problem drug, days using any drug, days of heavy drinking, and drug use based on analysis of hair samples. The primary outcome was self-reported days of use of the patient-defined primary problem drug during the 30-day period preceding the 3-month follow-up.
RESULTS


Follow-up rates were 89%, 86%, and 81% at 3, 6, and 12 months, respectively. For the primary outcome, estimated differences in number of days of use (95% CI) were as follows: MSO vs BI-B, 0.72 (-0.80 to 2.24), P (adjusted) = .57; SAR vs BI-B, 0.70 (-0.83 to 2.23), P (adjusted) = .57; SAR vs MSO, -0.02 (-1.53 to 1.50), P (adjusted) = .98. There were no significant differences between groups in self-reported days using the primary drug, days using any drug, or heavy drinking days at 3, 6, or 12 months. At the 3-month follow-up, participants in the SAR group had a higher rate of hair samples positive for their primary drug of abuse (265 of 280 [95%]) than did participants in the MSO group (253 of 287 [88%]) or the BI-B group (244 of 275 [89%]). Hair analysis differences between groups at other time points were not significant.
CONCLUSIONS AND RELEVANCE


In this sample of drug users seeking emergency medical treatment, a relatively robust brief intervention did not improve substance use outcomes. More work is needed to determine how drug use disorders may be addressed effectively in the ED.
TRIAL REGISTRATION


clinicaltrials.gov Identifier:NCT01207791.",2014,"At the 3-month follow-up, participants in the SAR group had a higher rate of hair samples positive for their primary drug of abuse (265 of 280 [95%]) than did participants in the MSO group (253 of 287 [88%]) or the BI-B group (244 of 275 [89%]).","['Between October 2010 and February 2012, 1285 adult ED patients from 6 US academic hospitals, who scored 3 or greater on the 10-item Drug Abuse Screening Test (indicating moderate to severe problems related to drug use) and who were currently using drugs', 'patients with problematic drug use presenting in emergency departments']","['Brief intervention', 'telephone boosters (BI-B) with those of screening, assessment, and referral to treatment (SAR) and minimal screening only (MSO', 'MSO']","['number of days of use', 'self-reported days using the patient-defined primary problem drug, days using any drug, days of heavy drinking, and drug use based on analysis of hair samples', 'self-reported days of use of the patient-defined primary problem drug during the 30-day period preceding the 3-month follow-up', 'rate of hair samples positive']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0451130', 'cui_str': 'Drug abuse screening test (assessment scale)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1697762', 'cui_str': 'Booster'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0444095', 'cui_str': 'Hair specimen (specimen)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",1285.0,0.12509,"At the 3-month follow-up, participants in the SAR group had a higher rate of hair samples positive for their primary drug of abuse (265 of 280 [95%]) than did participants in the MSO group (253 of 287 [88%]) or the BI-B group (244 of 275 [89%]).","[{'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Bogenschutz', 'Affiliation': 'Department of Psychiatry, University of New Mexico Health Sciences Center, Albuquerque2Center on Alcoholism, Substance Abuse, and Addictions, University of New Mexico, Albuquerque.'}, {'ForeName': 'Dennis M', 'Initials': 'DM', 'LastName': 'Donovan', 'Affiliation': 'Alcohol & Drug Abuse Institute, University of Washington, Seattle4Department of Psychiatry & Behavioral Sciences, University of Washington, Seattle.'}, {'ForeName': 'Raul N', 'Initials': 'RN', 'LastName': 'Mandler', 'Affiliation': 'National Institute on Drug Abuse, Bethesda, Maryland.'}, {'ForeName': 'Harold I', 'Initials': 'HI', 'LastName': 'Perl', 'Affiliation': 'National Institute on Drug Abuse, Bethesda, Maryland.'}, {'ForeName': 'Alyssa A', 'Initials': 'AA', 'LastName': 'Forcehimes', 'Affiliation': 'Department of Psychiatry, University of New Mexico Health Sciences Center, Albuquerque2Center on Alcoholism, Substance Abuse, and Addictions, University of New Mexico, Albuquerque.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Crandall', 'Affiliation': 'Department of Emergency Medicine, University of New Mexico Health Sciences Center, Albuquerque.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lindblad', 'Affiliation': 'The EMMES Corporation, Rockville, Maryland.'}, {'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Oden', 'Affiliation': 'The EMMES Corporation, Rockville, Maryland.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Sharma', 'Affiliation': 'The EMMES Corporation, Rockville, Maryland.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Metsch', 'Affiliation': 'Department of Public Health Sciences, Miller School of Medicine, University of Miami, Miami, Florida.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Lyons', 'Affiliation': 'Department of Emergency Medicine, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'McCormack', 'Affiliation': 'Department of Emergency Medicine, New York University School of Medicine, New York.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Macias-Konstantopoulos', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Boston12Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Douaihy', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}]",JAMA internal medicine,['10.1001/jamainternmed.2014.4052']
1716,32096313,Randomized clinical trials towards a single-visit cure for chronic hepatitis C: Oral GSK2878175 and injectable RG-101 in chronic hepatitis C patients and long-acting injectable GSK2878175 in healthy participants.,"Single-visit cures for chronic hepatitis C are lacking. We conducted two clinical studies towards the goal of developing a regimen for single-visit cure. In a randomized, open-label, Phase 2 study (RG101-04), investigators enrolled 26 adult chronic hepatitis C patients to evaluate safety and efficacy of single subcutaneous injection of RG-101 (4 mg/kg) and daily oral tablets of GSK2878175 (20 mg) for 6, 9 or 12 weeks. In another randomized, double-blind, single dose Phase 1 study (RG101-06), investigators enrolled 18 healthy men to assess safety and PK of GSK2878175 long-acting injectable at 100, 200 or 400 mg. In RG101-04, SVR48 rates were 50%, 56% and 89%, for the 6, 9 and 12 weeks treatment arms, respectively. All AEs were mild or moderate in severity (≤Grade 2). In RG101-06 at 400 mg, the mean duration of GSK2878175 plasma levels above in vitro therapeutic concentrations for GT1b was 41 days. All AEs were Grade 2 or less. In conclusion, single injection of RG-101 combined with 12 weeks of GSK2878175 oral tablets was generally well tolerated and resulted in high SVR rates in chronic hepatitis C patients. Single injections of GSK2878175 long-acting injectable were also well tolerated; however, higher doses would be required if used in combination with RG-101 to achieve the SVR rates observed in the oral combination study to enable a single-visit curative regimen.",2020,"In RG101-06 at 400 mg, the mean duration of GSK2878175 plasma levels above in vitro therapeutic concentrations for GT1b was 41 days.","['18 healthy men', 'Chronic Hepatitis C Patients and Long-Acting Injectable GSK2878175 in Healthy Participants', '26 adult chronic hepatitis C patients', 'chronic hepatitis C patients']",['RG-101 (4 mg/kg) and daily oral tablets of GSK2878175'],"['SVR rates', 'SVR48 rates', 'high SVR rates', 'mean duration of GSK2878175 plasma levels']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0524910', 'cui_str': 'Hepatitis C, Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0993159', 'cui_str': 'Oral Tablet'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",26.0,0.188458,"In RG101-06 at 400 mg, the mean duration of GSK2878175 plasma levels above in vitro therapeutic concentrations for GT1b was 41 days.","[{'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Campbell', 'Affiliation': 'GlaxoSmithKline, Stockley Park, Middlesex, UK.'}, {'ForeName': 'Kelong', 'Initials': 'K', 'LastName': 'Han', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Dickens', 'Initials': 'D', 'LastName': 'Theodore', 'Affiliation': 'GlaxoSmithKline, Research Triangle Park, North Carolina, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Deeg', 'Affiliation': 'Regulus Therapeutics Inc., San Diego, California, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Regulus Therapeutics Inc., San Diego, California, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hamatake', 'Affiliation': 'GlaxoSmithKline, Research Triangle Park, North Carolina, USA.'}, {'ForeName': 'Soumi', 'Initials': 'S', 'LastName': 'Lahiri', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Shuguang', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Gabor', 'Initials': 'G', 'LastName': 'Horvath', 'Affiliation': 'Buda Hepatology Center, Budapest, Hungary.'}, {'ForeName': 'Spilios', 'Initials': 'S', 'LastName': 'Manolakopoulos', 'Affiliation': '2nd Department of Internal Medicine, GI-Liver Unit, Hippocratio General Hospital of Athens, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'George N', 'Initials': 'GN', 'LastName': 'Dalekos', 'Affiliation': 'Department of Medicine and Research Laboratory of Internal Medicine, Institute of Internal Medicine and Hepatology, University Hospital of Larisa, Larisa, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Papatheodoridis', 'Affiliation': '2nd Department of Internal Medicine, GI-Liver Unit, Hippocratio General Hospital of Athens, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Goulis', 'Affiliation': 'Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Tivadar', 'Initials': 'T', 'LastName': 'Banyai', 'Affiliation': 'Bekes County Pandy Kalman Hospital, Gyula, Hungary.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Jilma', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Leivers', 'Affiliation': 'GlaxoSmithKline, Research Triangle Park, North Carolina, USA.'}]",Journal of viral hepatitis,['10.1111/jvh.13282']
1717,24404459,Evaluation of the efficacy of simplified Fencl-Stewart equation in analyzing the changes in acid base status following resuscitation with two different fluids.,"BACKGROUND


Metabolic acid-base disorders in critically ill patients may not be identified by base excess (BE) approach. Anion gap method can detect approximately 1/3 hidden ""gap acidosis"". In such conditions, when adjusted for hypoalbuminemia, Fencl-Stewart's approach can reliably detect the hidden abnormal anions.
AIM


Evaluate the efficacy of simplified Fencl-Stewart equation in identifying the changes in acid-base status of sepsis patients following resuscitation with two different fluids.
SETTINGS AND DESIGN


Intensive care unit, randomized, prospective, interventional study.
MATERIALS AND METHODS


Three hundred adult patients of both sexes presenting with abdominal sepsis, requiring fluid resuscitation were randomly assigned into normal saline (NS) and Ringer's lactate (RL) group, each comprising of 150 patients. 20 ml/kg of NS or RL were administered over a period of 30 min. The changes in the acid-base status were calculated applying the simplified Fencl-Stewart equation and was compared with the measured values obtained through arterial blood gas.
STATISTICAL METHODS


Paired t-test for intra-group while unpaired t-test for inter-group comparison.
RESULTS


Blood pH and standard BE decreased and the serum Na(+) and Cl(-) level increased significantly in NS group. The serum albumin level significantly decreased in both the groups. Sodium chloride effect on BE significantly increased in NS group. Albumin effect on BE significantly increased in both the groups. Unmeasured ion effect on BE did not significantly change in both the groups. Measured standard BE level was significantly less as compared to unmeasured anion effect on BE, in both the groups.
CONCLUSION


Simplified Fencl-Stewart equation is effective in identifying a mixed acid-base disorder, which otherwise would remain undetected.",2013,"RESULTS


Blood pH and standard BE decreased and the serum Na(+) and Cl(-) level increased significantly in NS group.","['sepsis patients following resuscitation with two different fluids', 'critically ill patients', 'Three hundred adult patients of both sexes presenting with abdominal sepsis, requiring fluid resuscitation']","['simplified Fencl-Stewart equation', ""normal saline (NS) and Ringer's lactate (RL"", 'Sodium chloride']","['serum albumin level', 'BE', 'Albumin effect on BE', 'Blood pH and standard BE decreased and the serum Na(+) and Cl(-) level', 'standard BE level']","[{'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1141926', 'cui_str': 'Abdominal sepsis'}]","[{'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0073385', 'cui_str': ""Hartmann's Solution""}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}]","[{'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum (procedure)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0853363', 'cui_str': 'Blood pH'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",300.0,0.220525,"RESULTS


Blood pH and standard BE decreased and the serum Na(+) and Cl(-) level increased significantly in NS group.","[{'ForeName': 'S Moied', 'Initials': 'SM', 'LastName': 'Ahmed', 'Affiliation': 'Department of Anaesthesiology and Critical Care, JN Medical College, AMU, Aligarh, India.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Maheshwari', 'Affiliation': 'Department of Anaesthesiology and Critical Care, JN Medical College, AMU, Aligarh, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Agarwal', 'Affiliation': 'Department of Anaesthesiology and Critical Care, JN Medical College, AMU, Aligarh, India.'}, {'ForeName': 'Abu', 'Initials': 'A', 'LastName': 'Nadeem', 'Affiliation': 'Department of Anaesthesiology and Critical Care, JN Medical College, AMU, Aligarh, India.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Singh', 'Affiliation': 'Department of Pulmonary Medicine and Critical Care, SRMS, Bareilley, India.'}]",International journal of critical illness and injury science,['10.4103/2229-5151.119203']
1718,24459620,Evaluation of the new supraglottic airway S.A.L.T to aid blind orotracheal intubation: A pilot study.,"BACKGROUND AND OBJECTIVE


Supraglottic Airway Laryngopharyngeal Tube (S.A.L.T) is a new airway gadget conceived as an effective device to facilitate blind oro-tracheal intubation. Literature review showed no available clinical study on human subjects. The aim of our study was to evaluate S.A.L.T as an adjunct to blind oro-tracheal intubation.
METHODS



STUDY DESIGN


Single centre, Single group, Open label, Prospective, Interventional pilot study.
STUDY GROUP


30 adult patients of either sex belonging to ASA I and II, scheduled for elective surgery under General anaesthesia. Patients were pre-medicated with inj. Glycopyrrolate 0.2 mg and inj. Midazolam 2 mg and induced with Inj. Propofol 2 mg/kg IV. After inj. Suxamethonium 1.5 mg/kg IV, S.A.L.T was inserted and a size 7.0 ID cuffed ETT was inserted through it immediately. The time period, from insertion of the S.A.L.T to the insertion of the ETT was noted. A successful intubation was defined as to insert SALT and intubate through it within 2 minutes irrespective of the number of attempts. Airway trauma, if any was recorded.
RESULTS


Only 40% of the patients were successfully intubated [(20.4% to 59.6% with 95% confidence interval (CI)]. The mean number of attempts required for intubation was 1.4 ± 0.67 (CI - 0.99 to 1.8) and the mean time for intubation was 26.3 ± 19.0 seconds (CI - 14.3 to 38.4 sec). Mallampati class I had more success rate than class III (P < 0.05). No airway trauma was recorded.
CONCLUSION


S.A.L.T shows limited usefulness as an adjunct for aided blind oro-tracheal intubation.",2013,I had more success rate than class III (P < 0.05).,"['30 adult patients of either sex belonging to ASA I and II, scheduled for elective surgery under General anaesthesia', 'human subjects']","['Propofol', 'Midazolam', 'Mallampati class', 'Glycopyrrolate', 'Suxamethonium', 'new supraglottic airway S.A.L.T to aid blind orotracheal intubation']","['No airway trauma', 'mean number of attempts required for intubation', 'mean time for intubation', 'success rate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C1829463', 'cui_str': 'Mallampati grade (observable entity)'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0038627', 'cui_str': 'suxamethonium'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C4076036', 'cui_str': 'Supraglottic airway (physical object)'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0396621', 'cui_str': 'Orotracheal intubation (procedure)'}]","[{'cui': 'C1301659', 'cui_str': 'Airway trauma'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",30.0,0.244461,I had more success rate than class III (P < 0.05).,"[{'ForeName': 'Vijay G', 'Initials': 'VG', 'LastName': 'Anand', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Tirunelveli Medical College Hospital, Tirunelveli, Tamil Nadu, India.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Girinivasan', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Tirunelveli Medical College Hospital, Tirunelveli, Tamil Nadu, India.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Leelakrishna', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Tirunelveli Medical College Hospital, Tirunelveli, Tamil Nadu, India.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Thavamani', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Tirunelveli Medical College Hospital, Tirunelveli, Tamil Nadu, India.'}]",International journal of critical illness and injury science,['10.4103/2229-5151.124112']
1719,25084694,Depressive Symptoms and Associated Clinical Characteristics in Outpatients Seeking Community-Based Treatment for Alcohol and Drug Problems.,"BACKGROUND


Comorbid psychiatric and substance use disorders are common and associated with poorer treatment engagement, retention, and outcomes. This study examines the presence of depressive symptoms and the demographic and clinical correlates in a diverse sample of substance abuse treatment seekers to better characterize patients with co-occurring depressive symptoms and substance use disorders and understand potential treatment needs.
METHODS


Baseline data from a randomized clinical effectiveness trial of a computer-assisted, Web-delivered psychosocial intervention were analyzed. Participants (N = 507) were recruited from 10 geographically diverse outpatient drug treatment programs. Assessments included the self-report Patient Health Questionnaire, and measures of coping strategies, social functioning, physical health status, and substance use.
RESULTS


One fifth (21%; n = 106) of the sample screened positive for depression; those screening positive for depression were significantly more likely to screen positive for anxiety (66.9%) and posttraumatic stress disorder (PTSD; 42.9%). After controlling for anxiety and PTSD symptoms, presence of depressive symptoms remained significantly associated with fewer coping strategies (P = .001), greater impairment in social adjustment (P < .001), and poorer health status (P < .001), but not to days of drug use in the last 90 days (P = .14).
CONCLUSIONS


Depression is a clinically significant problem among substance abusers, and, in this study, patients who screened positive for depression were more likely to have co-occurring symptoms of anxiety and PTSD. Additionally, the presence of depressive symptoms was associated with fewer coping strategies and poorer social adjustment. Coping skills are a significant predictor of addiction outcomes, and it may be especially important to screen for and enhance coping among depressed patients. Evidence-based interventions that target coping skills and global functioning among substance abusers with depressive symptoms may be important adjuncts to usual treatment.",2015,"After controlling for anxiety and PTSD symptoms, presence of depressive symptoms remained significantly associated with fewer coping strategies (P = .001), greater impairment in social adjustment (P < .001), and poorer health status (P < .001), but not to days of drug use in the last 90 days (P = .14).
","['Participants (N = 507) were recruited from 10 geographically diverse outpatient drug treatment programs', 'patients with co-occurring depressive symptoms and substance use disorders', 'substance abusers with depressive symptoms', 'Outpatients Seeking Community-Based Treatment for Alcohol and Drug Problems']","['computer-assisted, Web-delivered psychosocial intervention']","['Depressive Symptoms', 'coping strategies and poorer social adjustment', 'depressive symptoms', 'self-report Patient Health Questionnaire, and measures of coping strategies, social functioning, physical health status, and substance use', 'screen positive for anxiety', 'poorer health status', 'greater impairment in social adjustment', 'anxiety and PTSD symptoms, presence of depressive symptoms', 'posttraumatic stress disorder']","[{'cui': 'C0450381', 'cui_str': '507'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0338666', 'cui_str': 'Drug Users'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]","[{'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0037395', 'cui_str': 'Social Adjustment'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]",507.0,0.0597959,"After controlling for anxiety and PTSD symptoms, presence of depressive symptoms remained significantly associated with fewer coping strategies (P = .001), greater impairment in social adjustment (P < .001), and poorer health status (P < .001), but not to days of drug use in the last 90 days (P = .14).
","[{'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Sanchez', 'Affiliation': 'a School of Social Work , The University of Texas at Arlington , Arlington , Texas , USA.'}, {'ForeName': 'Robrina', 'Initials': 'R', 'LastName': 'Walker', 'Affiliation': ''}, {'ForeName': 'Aimee N C', 'Initials': 'AN', 'LastName': 'Campbell', 'Affiliation': ''}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Greer', 'Affiliation': ''}, {'ForeName': 'Mei-Chen', 'Initials': 'MC', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Grannemann', 'Affiliation': ''}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': ''}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': ''}]",Substance abuse,['10.1080/08897077.2014.937845']
1720,24072776,Metastatic melanoma: lactate dehydrogenase levels and CT imaging findings of tumor devascularization allow accurate prediction of survival in patients treated with bevacizumab.,"PURPOSE


To predict survival in patients with metastatic melanoma by evaluating a combination of serum lactate dehydrogenase (LDH) level and initial computed tomographic (CT) findings of tumor devascularization after antiangiogenic therapy.
MATERIALS AND METHODS


Consent was waived for this institutional review board-approved, retrospective, secondary analysis. Forty-four patients with metastatic melanoma received bevacizumab therapy in a randomized prospective phase II trial. Target lesions on the initial posttherapy CT images were evaluated by using Response Evaluation Criteria in Solid Tumors, the Choi criteria, and Morphology, Attenuation, Size, and Structure (MASS) criteria. Cox proportional hazards models were used to assess the association of baseline clinical variables including serum LDH and imaging findings with progression-free and overall survival. The receiver operating characteristic curve with area under the curve (AUC) was used to evaluate accuracy.
RESULTS


In multivariate analysis, a high baseline serum LDH level was associated with decreased progression-free survival (hazard ratio = 1.29 for each increase of 100 IU/L; P = .002) and overall survival (hazard ratio = 1.44 for each increase of 100 IU/L; P = .001). Evaluation with MASS criteria of the first CT examination after therapy strongly predicted progression-free (P < .001) and overall (P < .001) survival. Baseline serum LDH level was moderately accurate for predicting progression-free survival at 9 months (AUC = 0.793) and overall survival at 18 months (AUC = 0.689). The combination of baseline serum LDH levels and evaluation with MASS criteria at the first CT examination after therapy had significantly higher accuracy for predicting progression-free survival at 9 months (AUC = 0.969) and overall survival at 18 months (AUC = 0.813) than did baseline serum LDH levels alone for prediction of progression-free survival (P = .020).
CONCLUSION


A combination of baseline serum LDH levels and evaluation with MASS criteria at the first CT examination after bevacizumab therapy had the highest accuracy for predicting survival in patients with metastatic melanoma.",2014,Baseline serum LDH level was moderately accurate for predicting progression-free survival at 9 months (AUC = 0.793) and overall survival at 18 months (AUC = 0.689).,"['patients with metastatic melanoma by evaluating a combination of serum lactate dehydrogenase (LDH) level and initial computed tomographic (CT) findings of tumor devascularization after antiangiogenic therapy', 'patients with metastatic melanoma', 'patients treated with', 'Forty-four patients with metastatic melanoma']","['bevacizumab therapy', 'bevacizumab']","['progression-free', 'baseline serum LDH levels and evaluation with MASS criteria', 'overall survival', 'progression-free survival', 'high baseline serum LDH level', 'Baseline serum LDH level', 'serum LDH and imaging findings with progression-free and overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C1278052', 'cui_str': 'Serum lactate dehydrogenase measurement'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0581712', 'cui_str': 'Devascularization - action (qualifier value)'}, {'cui': 'C2363719', 'cui_str': 'Antiangiogenic therapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4319568', 'cui_str': '44'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1278052', 'cui_str': 'Serum lactate dehydrogenase measurement'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1287399', 'cui_str': 'Imaging finding'}]",44.0,0.294822,Baseline serum LDH level was moderately accurate for predicting progression-free survival at 9 months (AUC = 0.793) and overall survival at 18 months (AUC = 0.689).,"[{'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Gray', 'Affiliation': 'From the Department of Radiology, University of Mississippi Medical Center, 2500 N State St, Jackson, MS 39216.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Martin del Campo', 'Affiliation': ''}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Haowei', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Frederico F', 'Initials': 'FF', 'LastName': 'Souza', 'Affiliation': ''}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Carson', 'Affiliation': ''}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Smith', 'Affiliation': ''}]",Radiology,['10.1148/radiol.13130776']
1721,31390035,Effect of Telephone-Delivered Collaborative Goal Setting and Behavioral Activation vs Enhanced Usual Care for Depression Among Adults With Uncontrolled Diabetes: A Randomized Clinical Trial.,"Importance


Depression symptoms are present in one-third of patients with diabetes, contributing to significant adverse consequences. Population screening of high-risk patients coupled with telephone delivery of evidence-based therapies for comorbid diabetes may address barriers to care.
Objective


To evaluate the effectiveness of proactive population screening plus telephone delivery of a collaborative goal-setting intervention among high-risk patients with uncontrolled diabetes and depression.
Design, Setting, and Participants


In this randomized clinical trial, 225 participants (intervention [n = 136] and control [n = 89]) were enrolled from a regional Veterans Healthcare System serving Southeast Texas from November 1, 2012, through June 24, 2016. Data were gathered at baseline and 6 and 12 months after intervention. Patients selected had uncontrolled diabetes (hemoglobin A1c [HbA1c] >7.5%]) and clinically significant depression (Patient Health Questionnaire-9 scores [PHQ-9] ≥10) and were living more than 20 miles from the Veterans Affairs medical center. Data collection was completed on December 6, 2016, and final analyses were completed by January 25, 2018. All analyses were intent to treat.
Interventions


Healthy Outcomes Through Patient Empowerment (HOPE) included 9 telephone sessions with 24 trained health care professionals using collaborative goal-setting and behavioral activation methods. The control group received enhanced usual care (EUC) and notification of high-risk status.
Main Outcomes and Measures


Change in depression symptoms using PHQ-9 and glycemic control using HbA1c from baseline to 6 months and to 12 months. Secondary analyses evaluated clinically significant responses for these measures.
Results


Among 225 participants, 202 (89.8%) were men, the mean (SD) age was 61.9 (8.3) years, 145 (64.4%) were married, and 156 (69.3%) had some education beyond high school. For the overall study, 38 participants (16.9%) were lost to follow-up or withdrew at 6 months and another 21 (9.3%) were lost to follow-up or withdrew at 12 months. Repeated-measures analysis with multiple imputation for missing data assessing the interaction of treatment group (HOPE vs EUC) and time (baseline, 6 months, and 12 months) found no significant improvement in PHQ-9 (β, 1.56; 95% CI, -0.68 to 3.81; P = .17) or HbA1c (β, -0.005; 95% CI, -0.73 to 0.72; P = .82). Analyses using t test for change from baseline to 12 months showed a HOPE vs EUC between-group mean difference for PHQ-9 of 2.14 (95% CI, 0.18 to 4.10; P = .03) and for HbA1c of -0.06% (95% CI, -0.61% to 0.50%; P = .83). A secondary analysis of patients experiencing a clinical response found that 52.1% of HOPE participants had clinically significant responses in PHQ-9 at 12 months vs 32.9% in EUC (difference, 0.19; 95% CI, 0.04-0.33; P = .01).
Conclusions and Relevance


Telephone-delivered, collaborative goal setting produced clinically significant reductions in depression symptoms but not glycemic control among patients who remained engaged at 12 months compared with EUC among a population screened sample of high-risk patients with diabetes and depression. Although the intervention created some lasting effect for depression, additional strategies are needed to maintain engagement of this high-risk population within an interprofessional team approach to primary care.
Trial Registration


ClinicalTrials.gov identifier: NCT01572389.",2019,"Analyses using t test for change from baseline to 12 months showed a HOPE vs EUC between-group mean difference for PHQ-9 of 2.14 (95% CI, 0.18 to 4.10; P = .03) and for HbA1c of -0.06% (95% CI, -0.61% to 0.50%; P = .83).","['Healthy Outcomes Through Patient Empowerment (HOPE) included 9 telephone sessions with 24 trained health care professionals using collaborative goal-setting and behavioral activation methods', 'Patients selected had uncontrolled diabetes (hemoglobin A1c', '225 participants (intervention [n\u2009=\u2009136] and control [n\u2009=\u200989]) were enrolled from a regional Veterans Healthcare System serving Southeast Texas from November 1, 2012, through June 24, 2016', 'the mean (SD) age was 61.9 (8.3) years, 145 (64.4%) were married, and 156 (69.3%) had some education beyond high school', 'Adults With Uncontrolled Diabetes', 'high-risk patients with uncontrolled diabetes and depression', '225 participants, 202 (89.8%) were men']","['Telephone-Delivered Collaborative Goal Setting and Behavioral Activation vs Enhanced Usual Care for Depression', 'proactive population screening plus telephone delivery of a collaborative goal-setting intervention', 'EUC', 'enhanced usual care (EUC) and notification of high-risk status']","['depression symptoms', 'depression symptoms using PHQ-9 and glycemic control using HbA1c', 'PHQ-9']","[{'cui': 'C3853035', 'cui_str': 'Patient Empowerment'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0150598', 'cui_str': 'Goal setting (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0150598', 'cui_str': 'Goal setting (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0422202', 'cui_str': 'Notifications (procedure)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}]",225.0,0.255136,"Analyses using t test for change from baseline to 12 months showed a HOPE vs EUC between-group mean difference for PHQ-9 of 2.14 (95% CI, 0.18 to 4.10; P = .03) and for HbA1c of -0.06% (95% CI, -0.61% to 0.50%; P = .83).","[{'ForeName': 'Aanand D', 'Initials': 'AD', 'LastName': 'Naik', 'Affiliation': 'Research Service Line, Houston Center for Innovations in Quality, Effectiveness, and Safety, Michael E. DeBakey VA Medical Center, Houston, Texas.'}, {'ForeName': 'Natalie E', 'Initials': 'NE', 'LastName': 'Hundt', 'Affiliation': 'Research Service Line, Houston Center for Innovations in Quality, Effectiveness, and Safety, Michael E. DeBakey VA Medical Center, Houston, Texas.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Vaughan', 'Affiliation': 'Alkek Department of Medicine, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Nancy J', 'Initials': 'NJ', 'LastName': 'Petersen', 'Affiliation': 'Research Service Line, Houston Center for Innovations in Quality, Effectiveness, and Safety, Michael E. DeBakey VA Medical Center, Houston, Texas.'}, {'ForeName': 'Darrell', 'Initials': 'D', 'LastName': 'Zeno', 'Affiliation': 'Research Service Line, Houston Center for Innovations in Quality, Effectiveness, and Safety, Michael E. DeBakey VA Medical Center, Houston, Texas.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Kunik', 'Affiliation': 'Research Service Line, Houston Center for Innovations in Quality, Effectiveness, and Safety, Michael E. DeBakey VA Medical Center, Houston, Texas.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Cully', 'Affiliation': 'Research Service Line, Houston Center for Innovations in Quality, Effectiveness, and Safety, Michael E. DeBakey VA Medical Center, Houston, Texas.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.8634']
1722,24229749,Treating nicotine dependence by targeting attention-deficit/ hyperactivity disorder (ADHD) with OROS methylphenidate: the role of baseline ADHD severity and treatment response.,"OBJECTIVE


To determine whether treatment of attention-deficit/hyperactivity disorder (ADHD) with osmotic-release oral system (OROS) methylphenidate promotes abstinence from smoking among smokers with ADHD who have greater severity of ADHD symptoms at baseline or greater improvement in ADHD during treatment.
METHOD


This is a secondary analysis of data from a randomized, double-blind, 11-week trial conducted between December 2005 and January 2008 at 6 clinical sites; the original trial was sponsored by the National Drug Abuse Clinical Trials Network. Adult cigarette smokers (aged 18-55 years) who met DSM-IV criteria for ADHD were randomly assigned to OROS methylphenidate (72 mg/d) (n = 127) or matching placebo (n = 128). All participants received nicotine patches (21 mg/d) and weekly individual smoking cessation counseling. Logistic regression was used to model prolonged abstinence from smoking (ascertained by self-report and breath carbon monoxide testing) as a function of treatment, baseline ADHD Rating Scale-IV (ADHD-RS) score, change in ADHD-RS score during treatment, and their interactions.
RESULTS


Treatment interacted with both ADHD-RS score at baseline (P = .01) and change in ADHD-RS score during treatment (P = .008). Among patients with higher ADHD-RS scores (> 36) at baseline and the most improvement in ADHD during treatment (ADHD-RS change score ≥ 24), 70.0% of those who took OROS methylphenidate achieved abstinence from smoking compared to 36.8% of those who took placebo (P = .02). In contrast, among patients with the lowest ADHD-RS baseline scores (≤ 30), 30.3% of those who took OROS methylphenidate achieved abstinence from smoking compared to 60.7% of those who took placebo (P = .02).
CONCLUSIONS


OROS methylphenidate, in combination with nicotine patch, may be an effective treatment for nicotine dependence among smokers with more severe ADHD and more robust response of ADHD symptoms to medication. OROS methylphenidate may be counterproductive among smokers with lower severity of ADHD.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT00253747.",2013,"RESULTS


Treatment interacted with both ADHD-RS score at baseline (P = .01) and change in ADHD-RS score during treatment (P = .008).","['smokers with ADHD who have greater severity of ADHD symptoms at baseline or greater improvement in ADHD during treatment', 'Adult cigarette smokers (aged 18-55 years) who met DSM-IV criteria for ADHD', 'December 2005 and January 2008 at 6 clinical sites; the original trial was sponsored by the National Drug Abuse Clinical Trials Network', 'smokers with lower severity of ADHD']","['OROS methylphenidate', 'osmotic-release oral system (OROS) methylphenidate', 'matching placebo', 'placebo', 'nicotine patches', 'individual smoking cessation counseling', 'nicotine patch']","['abstinence from smoking', 'change in ADHD-RS score', 'ADHD-RS score', 'baseline ADHD Rating Scale-IV (ADHD-RS) score, change in ADHD-RS score']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0013146', 'cui_str': 'Drug abuse (disorder)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}]",,0.120895,"RESULTS


Treatment interacted with both ADHD-RS score at baseline (P = .01) and change in ADHD-RS score during treatment (P = .008).","[{'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'New York State Psychiatric Institute, 1051 Riverside Drive, Unit 51, Room 3717, New York, NY 10032 nunesed@nyspi.columbia.edu.'}, {'ForeName': 'Lirio S', 'Initials': 'LS', 'LastName': 'Covey', 'Affiliation': ''}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Brigham', 'Affiliation': ''}, {'ForeName': 'Mei-Chen', 'Initials': 'MC', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Frances R', 'Initials': 'FR', 'LastName': 'Levin', 'Affiliation': ''}, {'ForeName': 'Eugene C', 'Initials': 'EC', 'LastName': 'Somoza', 'Affiliation': ''}, {'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Winhusen', 'Affiliation': ''}]",The Journal of clinical psychiatry,['10.4088/JCP.12m08155']
1723,31390037,Efficacy of a Technology-Enhanced Community Health Nursing Intervention vs Standard of Care for Female Adolescents and Young Adults With Pelvic Inflammatory Disease: A Randomized Clinical Trial.,"Importance


Pelvic inflammatory disease (PID) is a common reproductive health disorder that disproportionately affects female adolescents and young adults. Despite data indicating poor adherence and adverse outcomes among those who experience subsequent Neisseria gonorrhoeae and Chlamydia trachomatis infection, few trials have been designed to address this public health need.
Objective


To examine the efficacy of a technology-enhanced community health nursing (TECH-N) intervention vs standard of care for improving PID self-management behaviors and 90-day longitudinal prevalence of N gonorrhoeae and C trachomatis infection.
Design, Setting, and Participants


This randomized clinical trial of the TECH-N intervention was conducted among female patients 13 to 25 years of age diagnosed with mild to moderate PID who were being discharged to outpatient treatment from September 6, 2012, to December 8, 2016, at a large academic medical center. The final analysis of data was completed in November 2018. This study compared the efficacy of the intervention with that of the standard of care using an intention-to-treat analysis.
Interventions


Enrolled participants completed an audio computer-assisted self-interview, provided specimens for N gonorrhoeae and C trachomatis testing, and were randomized to standard treatment (n = 137) or the TECH-N intervention (n = 149). Intervention participants received text-messaging support and a community health nurse visit within 5 days of diagnosis. Change in the prevalence of N gonorrhoeae and C trachomatis infection was estimated with logistic regression. The N gonorrhoeae and C trachomatis positivity rate over time was evaluated using generalized estimating equations.
Main Outcomes and Measures


The primary outcome was the prevalence of N gonorrhoeae and C trachomatis infection at 90-day follow-up. The secondary outcome was adherence to the Centers for Disease Control and Prevention recommendations for self-care.
Results


A total of 286 patients (mean [SD] age, 18.8 [2.5] years; 268 [93.7%] African American) participated in the study. Although the study groups were demographically similar, the intervention group had a higher baseline rate of C trachomatis infection (45 of 139 [32.4%] vs 25 of 132 [18.9%], P = .01). Although N gonorrhoeae and C trachomatis positivity was not statistically different between groups at 90-day follow-up (6 of 135 [4.4%] vs 13 of 125 [10.4%], P = .07), the differential rate of decrease was significantly higher in the intervention group (48 of 140 [34.4%] to 6 of 135 [4.4%] compared with 34 of 133 [25.6%] to 13 of 112 [10.4%], P = .02). Intervention participants were more likely to receive the Centers for Disease Control and Prevention-recommended short-term follow-up visit compared with the control group (131 of 139 [94.2%] vs 20 of 123 [16.3%], P < .001).
Conclusions and Relevance


Adolescent and young adults with PID in the TECH-N intervention were more likely to experience decreases in N gonorrhoeae and C trachomatis positivity compared with the control group and to receive short-term clinical assessment. These findings suggest that the TECH-N intervention should be considered as a potential enhancement of standard of care approaches for management of female adolescents and young adults with mild to moderate PID in urban communities facing significant sexually transmitted infection disparities.
Trial Registration


ClinicalTrials.gov identifier: NCT01640379.",2019,"Although N gonorrhoeae and C trachomatis positivity was not statistically different between groups at 90-day follow-up (6 of 135 [4.4%] vs 13 of 125 [10.4%], P = .07), the differential rate of decrease was significantly higher in the intervention group (48 of 140 [34.4%] to 6 of 135 [4.4%] compared with 34 of 133 [25.6%] to 13 of 112 [10.4%], P = .02).","['286 patients (mean [SD] age, 18.8 [2.5] years; 268 [93.7%] African American) participated in the study', 'Female Adolescents and Young Adults With Pelvic Inflammatory Disease', 'female adolescents and young adults', 'female patients 13 to 25 years of age diagnosed with mild to moderate PID who were being discharged to outpatient treatment from September 6, 2012, to December 8, 2016, at a large academic medical center']","['TECH-N intervention', 'text-messaging support and a community health nurse visit', 'Technology-Enhanced Community Health Nursing Intervention vs Standard of Care', 'audio computer-assisted self-interview, provided specimens for N gonorrhoeae and C trachomatis testing', 'technology-enhanced community health nursing (TECH-N) intervention vs standard of care']","['baseline rate of C trachomatis infection', 'prevalence of N gonorrhoeae and C trachomatis infection', 'C trachomatis positivity', 'differential rate of decrease', 'adherence to the Centers for Disease Control and Prevention recommendations for self-care', 'Centers for Disease Control and Prevention-recommended short-term follow-up visit']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0242172', 'cui_str': 'Pelvic Inflammatory Disease'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1522710', 'cui_str': 'Nurses, Community Health'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0009471', 'cui_str': 'Community Health Nursing'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]","[{'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0007670', 'cui_str': 'CDC'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit (procedure)'}]",286.0,0.0756613,"Although N gonorrhoeae and C trachomatis positivity was not statistically different between groups at 90-day follow-up (6 of 135 [4.4%] vs 13 of 125 [10.4%], P = .07), the differential rate of decrease was significantly higher in the intervention group (48 of 140 [34.4%] to 6 of 135 [4.4%] compared with 34 of 133 [25.6%] to 13 of 112 [10.4%], P = .02).","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Trent', 'Affiliation': 'Section on Adolescent/Young Adult Medicine, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Perin', 'Affiliation': 'Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Gaydos', 'Affiliation': 'Johns Hopkins International STD Laboratory, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Anders', 'Affiliation': 'Division of Pediatric Emergency Medicine, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Shang-En', 'Initials': 'SE', 'LastName': 'Chung', 'Affiliation': 'Section on Adolescent/Young Adult Medicine, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tabacco Saeed', 'Affiliation': 'Section on Adolescent/Young Adult Medicine, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Rowell', 'Affiliation': 'Section on Adolescent/Young Adult Medicine, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Huettner', 'Affiliation': 'Section on Adolescent/Young Adult Medicine, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Rothman', 'Affiliation': 'Department of Adult Emergency Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Butz', 'Affiliation': 'Division of General Pediatrics and Adolescent Medicine, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.8652']
1724,24849545,The combination of insulin-like growth factor receptor 1 (IGF1R) antibody cixutumumab and mitotane as a first-line therapy for patients with recurrent/metastatic adrenocortical carcinoma: a multi-institutional NCI-sponsored trial.,"Adrenocortical carcinoma (ACC) is an aggressive malignancy, which lacks an effective systemic treatment. Abnormal activation of insulin-like growth factor receptor 1 (IGF1R) has been frequently observed. Preclinical studies demonstrated that pharmacological inhibition of IGF1R signaling in ACC has antiproliferative effects. A previous phase I trial with an IGF1R inhibitor has demonstrated biological activity against ACC. The objective of this study is to assess the efficacy of the combination of the IGF1R inhibitor cixutumumab (IMC-A12) in association with mitotane as a first-line treatment for advanced/metastatic ACC. We conducted a multicenter, randomized double-arm phase II trial in patients with irresectable recurrent/metastatic ACC. The original protocol included two treatment groups: IMC-A12 + mitotane and mitotane as a single agent, after an initial single-arm phase for safety evaluation with IMC-A12 + mitotane. IMC-A12 was dosed at 10 mg/kg intravenously every 2 weeks. The starting dose for mitotane was 2 g daily, subsequently adjusted according to serum levels/symptoms. The primary endpoint was progression-free survival (PFS) according to RECIST (Response Evaluation Criteria in Solid Tumors). This study was terminated before the randomization phase due to slow accrual and limited efficacy. Twenty patients (13 males, 7 females) with a median age of 50.2 years (range 21.9-79.6) were enrolled for the single-arm phase. Therapeutic effects were observed in 8/20 patients, including one partial response and seven stable diseases. The median PFS was 6 weeks (range 2.66-48). Toxic events included two grade 4 (hyperglycemia and hyponatremia) and one grade 5 (multiorgan failure). Although the regimen demonstrated activity in some patients, the relatively low therapeutic efficacy precluded further studies with this combination of drugs.",2014,The primary endpoint was progression-free survival (PFS) according to RECIST (Response Evaluation Criteria in Solid Tumors).,"['patients with recurrent/metastatic adrenocortical carcinoma', 'Adrenocortical carcinoma (ACC', 'Twenty patients (13 males, 7 females) with a median age of 50.2 years (range 21.9-79.6) were enrolled for the single-arm phase', 'patients with irresectable recurrent/metastatic ACC', 'advanced/metastatic ACC']","['IGF1R inhibitor cixutumumab (IMC-A12', 'IMC-A12 + mitotane and mitotane', 'insulin-like growth factor receptor 1 (IGF1R) antibody cixutumumab and mitotane', 'IMC-A12 + mitotane', 'IGF1R inhibitor']","['median PFS', 'progression-free survival (PFS) according to RECIST (Response Evaluation Criteria in Solid Tumors', 'grade 4 (hyperglycemia and hyponatremia) and one grade 5 (multiorgan failure', 'Therapeutic effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0206686', 'cui_str': 'Carcinoma, Adrenal Cortical'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2699335'}, {'cui': 'C2703174', 'cui_str': 'IMC-A12'}, {'cui': 'C0026256', 'cui_str': 'Mitotane'}, {'cui': 'C0140079', 'cui_str': 'Insulin-Like Growth Factor Receptor'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0026766', 'cui_str': 'Organ Dysfunction Syndrome, Multiple'}, {'cui': 'C1527144'}]",,0.058504,The primary endpoint was progression-free survival (PFS) according to RECIST (Response Evaluation Criteria in Solid Tumors).,"[{'ForeName': 'Antonio M', 'Initials': 'AM', 'LastName': 'Lerario', 'Affiliation': 'Division of Metabolism, Endocrinology & Diabetes, Medical School, University of Michigan, 109 Zina Pitcher Place, 1528 BSRB, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Francis P', 'Initials': 'FP', 'LastName': 'Worden', 'Affiliation': ''}, {'ForeName': 'Carole A', 'Initials': 'CA', 'LastName': 'Ramm', 'Affiliation': ''}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Hesseltine', 'Affiliation': ''}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Hasseltine', 'Affiliation': ''}, {'ForeName': 'Walter M', 'Initials': 'WM', 'LastName': 'Stadler', 'Affiliation': ''}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Else', 'Affiliation': ''}, {'ForeName': 'Manisha H', 'Initials': 'MH', 'LastName': 'Shah', 'Affiliation': ''}, {'ForeName': 'Edem', 'Initials': 'E', 'LastName': 'Agamah', 'Affiliation': ''}, {'ForeName': 'Krishna', 'Initials': 'K', 'LastName': 'Rao', 'Affiliation': ''}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Hammer', 'Affiliation': ''}]",Hormones & cancer,['10.1007/s12672-014-0182-1']
1725,24345356,A randomized trial of concurrent smoking-cessation and substance use disorder treatment in stimulant-dependent smokers.,"OBJECTIVE


To evaluate the impact of concurrent treatments for substance use disorder and nicotine-dependence for stimulant-dependent patients.
METHOD


A randomized, 10-week trial with follow-up at 3 and 6 months after smoking quit date conducted at 12 substance use disorder treatment programs between February 2010 and July 2012. Adults meeting DSM-IV-TR criteria for cocaine and/or methamphetamine dependence and interested in quitting smoking were randomized to treatment as usual (n = 271) or treatment as usual with smoking-cessation treatment (n = 267). All participants received treatment as usual for substance use disorder treatment. Participants assigned to treatment as usual with concurrent smoking-cessation treatment received weekly individual smoking cessation counseling and extended-release bupropion (300 mg/d) during weeks 1-10. During post-quit treatment (weeks 4-10), participants assigned to treatment as usual with smoking-cessation treatment received a nicotine inhaler and contingency management for smoking abstinence. Weekly proportion of stimulant-abstinent participants during the treatment phase, as assessed by urine drug screens and self-report, was the primary outcome. Secondary measures included other substance/nicotine use outcomes and treatment attendance.
RESULTS


There were no significant treatment effects on stimulant-use outcomes, as measured by the primary outcome and stimulant-free days, on drug-abstinence, or on attendance. Participants assigned to treatment as usual with smoking-cessation treatment, relative to those assigned to treatment as usual, had significantly better outcomes for drug-free days at 6-month follow-up (χ(2)(1) = 4.09, P <.05), with a decrease in drug-free days from baseline of -1.3% in treatment as usual with smoking-cessation treatment and of -7.6% in treatment as usual. Participants receiving treatment as usual with smoking-cessation treatment, relative to those receiving treatment as usual, had significantly better outcomes on smoking point-prevalence abstinence (25.5% vs 2.2%; χ(2)(1) = 44.69, P < .001; OR =18.2).
CONCLUSIONS


These results suggest that providing smoking-cessation treatment to illicit stimulant-dependent patients in outpatient substance use disorder treatment will not worsen, and may enhance, abstinence from nonnicotine substance use.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT01077024.",2014,"Participants receiving treatment as usual with smoking-cessation treatment, relative to those receiving treatment as usual, had significantly better outcomes on smoking point-prevalence abstinence (25.5% vs 2.2%; χ(2)(1) = 44.69, P < .001;","['stimulant-dependent smokers', 'Adults meeting DSM-IV-TR criteria for cocaine and/or methamphetamine dependence and interested in quitting smoking', 'stimulant-dependent patients', '12 substance use disorder treatment programs between February 2010 and July 2012']","['nicotine inhaler and contingency management for smoking abstinence', 'usual with concurrent smoking-cessation treatment received weekly individual smoking cessation counseling and extended-release bupropion', 'concurrent smoking-cessation and substance use disorder treatment', 'usual with smoking-cessation treatment']","['stimulant-free days, on drug-abstinence, or on attendance', 'smoking point-prevalence abstinence', 'substance/nicotine use outcomes and treatment attendance']","[{'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C1533217', 'cui_str': 'Methamphetamine dependence (disorder)'}, {'cui': 'C0543488', 'cui_str': 'Interested (finding)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0581116', 'cui_str': 'Dependent patient (finding)'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0814019', 'cui_str': 'Nicotine inhaler'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}]","[{'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.0628819,"Participants receiving treatment as usual with smoking-cessation treatment, relative to those receiving treatment as usual, had significantly better outcomes on smoking point-prevalence abstinence (25.5% vs 2.2%; χ(2)(1) = 44.69, P < .001;","[{'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Winhusen', 'Affiliation': 'University of Cincinnati, 3210 Jefferson Ave, Cincinnati, OH 45220 winhusen@carc.uc.edu.'}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Brigham', 'Affiliation': ''}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Kropp', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lindblad', 'Affiliation': ''}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Gardin', 'Affiliation': ''}, {'ForeName': 'Pat', 'Initials': 'P', 'LastName': 'Penn', 'Affiliation': ''}, {'ForeName': 'Candace', 'Initials': 'C', 'LastName': 'Hodgkins', 'Affiliation': ''}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Kelly', 'Affiliation': ''}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Douaihy', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McCann', 'Affiliation': ''}, {'ForeName': 'Lee D', 'Initials': 'LD', 'LastName': 'Love', 'Affiliation': ''}, {'ForeName': 'Eliot', 'Initials': 'E', 'LastName': 'DeGravelles', 'Affiliation': ''}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Bachrach', 'Affiliation': ''}, {'ForeName': 'Susan C', 'Initials': 'SC', 'LastName': 'Sonne', 'Affiliation': ''}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Hiott', 'Affiliation': ''}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Haynes', 'Affiliation': ''}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Sharma', 'Affiliation': ''}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'VanVeldhuisen', 'Affiliation': ''}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Theobald', 'Affiliation': ''}, {'ForeName': 'Udi', 'Initials': 'U', 'LastName': 'Ghitza', 'Affiliation': ''}]",The Journal of clinical psychiatry,['10.4088/JCP.13m08449']
1726,24911028,"Multisite, randomized, double-blind, placebo-controlled pilot clinical trial to evaluate the efficacy of buspirone as a relapse-prevention treatment for cocaine dependence.","OBJECTIVE


To evaluate the potential efficacy of buspirone as a relapse-prevention treatment for cocaine dependence.
METHOD


A randomized, double-blind, placebo-controlled, 16-week pilot trial was conducted at 6 clinical sites between August 2012 and June 2013. Adult crack cocaine users meeting DSM-IV-TR criteria for current cocaine dependence who were scheduled to be in inpatient/residential substance use disorder (SUD) treatment for 12-19 days when randomized and planning to enroll in local outpatient treatment through the end of the active treatment phase were randomized to buspirone titrated to 60 mg/d (n = 35) or placebo (n = 27). All participants received psychosocial treatment as usually provided by the SUD treatment programs in which they were enrolled. Outcome measures included maximum days of continuous cocaine abstinence (primary), proportion of cocaine use days, and days to first cocaine use during the outpatient treatment phase (study weeks 4-15) as assessed by self-report and urine drug screens.
RESULTS


There were no significant treatment effects on maximum continuous days of cocaine abstinence or days to first cocaine use. In the female participants (n = 23), there was a significant treatment-by-time interaction effect (χ²₁ = 15.26, P < .0001), reflecting an increase in cocaine use by those receiving buspirone, relative to placebo, early in the outpatient treatment phase. A similar effect was not detected in the male participants (n = 39; χ²₁ = 0.14, P = .70).
CONCLUSIONS


The results suggest that buspirone is unlikely to have a beneficial effect on preventing relapse to cocaine use and that buspirone for cocaine-dependent women may worsen their cocaine use outcomes.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT01641159.",2014,There were no significant treatment effects on maximum continuous days of cocaine abstinence or days to first cocaine use.,"['Adult crack cocaine users meeting DSM-IV-TR criteria for current cocaine dependence who were scheduled to be in inpatient/residential substance use disorder (SUD) treatment for 12-19 days when randomized and planning to enroll in local outpatient treatment through the end of the active treatment phase', '6 clinical sites between August 2012 and June 2013', 'cocaine dependence']","['buspirone', 'placebo']","['maximum days of continuous cocaine abstinence (primary), proportion of cocaine use days, and days to first cocaine use during the outpatient treatment phase (study weeks 4-15) as assessed by self-report and urine drug screens']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0085163', 'cui_str': 'Crack Cocaine'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0600427', 'cui_str': 'Cocaine Dependence'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0006462', 'cui_str': 'Buspirone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}]",,0.274459,There were no significant treatment effects on maximum continuous days of cocaine abstinence or days to first cocaine use.,"[{'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Winhusen', 'Affiliation': 'University of Cincinnati, Department of Psychiatry, 3131 Harvey Ave, Cincinnati, OH 45229 winhust@uc.edu.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Kropp', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lindblad', 'Affiliation': ''}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Douaihy', 'Affiliation': ''}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Haynes', 'Affiliation': ''}, {'ForeName': 'Candace', 'Initials': 'C', 'LastName': 'Hodgkins', 'Affiliation': ''}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Chartier', 'Affiliation': ''}, {'ForeName': 'Kyle M', 'Initials': 'KM', 'LastName': 'Kampman', 'Affiliation': ''}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Sharma', 'Affiliation': ''}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'VanVeldhuisen', 'Affiliation': ''}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Theobald', 'Affiliation': ''}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'May', 'Affiliation': ''}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Brigham', 'Affiliation': ''}]",The Journal of clinical psychiatry,['10.4088/JCP.13m08862']
1727,32075607,Impact of a one-year school-based teacher-implemented nutrition and physical activity intervention: main findings and future recommendations.,"BACKGROUND


The aim of the current study is to describe the effectiveness of a school-based intervention when delivered by a non-nutrition specialist (trained schoolteachers) as compared to an expert in nutrition.
METHODS


Two trials of the same school-based intervention using the same intervention package were delivered, one by nutritionists and another by trained schoolteachers. The intervention focused mainly on dietary behaviours, as well as physical activity. In both trials, purposively selected schools were randomized to intervention or control groups; students (aged 9-11 years) in both groups were compared at post-test on knowledge and self-efficacy scores, as well as dietary and physical activity behaviours, controlling for their baseline status on the various measures. All analyses accounted for clustering at the school level.
RESULTS


In both trials, a statistically significantly greater improvement was observed for both the knowledge and self-efficacy scores in intervention vs. school students. When the programme was delivered by trained schoolteachers, frequency of breakfast intake was increased, crisps consumption was reduced, but no change in fruit and vegetable consumption was observed (latter increased when delivered by nutrition professionals only). Physical activity did not improve in both trials.
CONCLUSION


Trained schoolteachers can have a positive impact on students' dietary behaviours with the appropriate training to ensure they are equipped with the right information, skills, and resources to deliver the programme with the highest fidelity.
TRIAL REGISTRATION


ClinicalTrial.gov Identifier: NCT03040271. Retrospectively registered on 2 February 2017.",2020,"In both trials, a statistically significantly greater improvement was observed for both the knowledge and self-efficacy scores in intervention vs. school students.",[],"['school-based intervention', 'one-year school-based teacher-implemented nutrition and physical activity intervention']","['fruit and vegetable consumption', 'crisps consumption', 'Physical activity', 'knowledge and self-efficacy scores']",[],"[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0349380', 'cui_str': 'Potato chips'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0263153,"In both trials, a statistically significantly greater improvement was observed for both the knowledge and self-efficacy scores in intervention vs. school students.","[{'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Habib-Mourad', 'Affiliation': 'Department of Nutrition and Food Sciences, American University of Beirut, Riad El-Solh, Beirut, 1107-2020, Lebanon.'}, {'ForeName': 'Lilian A', 'Initials': 'LA', 'LastName': 'Ghandour', 'Affiliation': 'Department of Epidemiology and Population Health, American University of Beirut, Riad El-Solh, Beirut, 1107-2020, Lebanon. lg01@aub.edu.lb.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Maliha', 'Affiliation': 'Department of Nutrition and Food Sciences, American University of Beirut, Riad El-Solh, Beirut, 1107-2020, Lebanon.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Awada', 'Affiliation': 'Department of Nutrition and Food Sciences, American University of Beirut, Riad El-Solh, Beirut, 1107-2020, Lebanon.'}, {'ForeName': 'Michèle', 'Initials': 'M', 'LastName': 'Dagher', 'Affiliation': 'Department of Nutrition and Food Sciences, American University of Beirut, Riad El-Solh, Beirut, 1107-2020, Lebanon.'}, {'ForeName': 'Nahla', 'Initials': 'N', 'LastName': 'Hwalla', 'Affiliation': 'Department of Nutrition and Food Sciences, American University of Beirut, Riad El-Solh, Beirut, 1107-2020, Lebanon.'}]",BMC public health,['10.1186/s12889-020-8351-3']
1728,24106976,Family discord is associated with increased substance use for pregnant substance users.,"Childhood abuse and partner violence are associated with prenatal substance abuse, but the potential impact of current family discord, which reflects broader family relationships and encompasses problems less severe than violence, has had little evaluation in pregnant substance users. Using data from 196 pregnant substance users participating in a NIDA Clinical Trials Network randomized clinical trial, we examined the relationship of baseline family discord to substance use and treatment session attendance. Family discord was assessed using items from the family composite of the Addiction Severity Index. Substance use was assessed by the Substance Use Calendar and urine drug screens (UDS). Assessments were weekly for four weeks and at two- and four-month post-randomization. Women with family discord were more likely to report living with a problematic substance user, reported a higher percentage of substance use days throughout each study phase, had a greater proportion of positive UDS over the four-month study period, and attended more weeks of treatment during the first month. Specific treatment interventions targeting pregnant women with family discord may be warranted.",2014,"Women with family discord were more likely to report living with a problematic substance user, reported a higher percentage of substance use days throughout each study phase, had a greater proportion of positive UDS over the four-month study period, and attended more weeks of treatment during the first month.","['196 pregnant substance users participating in a NIDA Clinical Trials Network randomized clinical trial', 'pregnant women with family discord', 'pregnant substance users']",[],['positive UDS'],"[{'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0338666', 'cui_str': 'Drug Users'}, {'cui': 'C0068218', 'cui_str': 'NIDA'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0206034', 'cui_str': 'Clinical Trials, Randomized'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0015576', 'cui_str': 'Family'}]",[],"[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",196.0,0.0502409,"Women with family discord were more likely to report living with a problematic substance user, reported a higher percentage of substance use days throughout each study phase, had a greater proportion of positive UDS over the four-month study period, and attended more weeks of treatment during the first month.","[{'ForeName': 'Wayne H', 'Initials': 'WH', 'LastName': 'Denton', 'Affiliation': '1Florida State University, Family and Child Sciences , Tallahassee, Florida , USA.'}, {'ForeName': 'Bryon H', 'Initials': 'BH', 'LastName': 'Adinoff', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'Robrina', 'Initials': 'R', 'LastName': 'Walker', 'Affiliation': ''}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': ''}]",Substance use & misuse,['10.3109/10826084.2013.840002']
1729,24382603,Project STYLE: a multisite RCT for HIV prevention among youths in mental health treatment.,"OBJECTIVE


The study examined the efficacy of family-based and adolescent-only HIV prevention programs in decreasing HIV risk and improving parental monitoring and sexual communication among youths in mental health treatment.
METHODS


A randomized controlled trial (RCT) with 721 adolescents (ages 13-18 years) and their caregivers from mental health settings in three U.S. cities were randomly assigned to one of three theory-based, structured group interventions: family-based HIV prevention, adolescent-only HIV prevention, and adolescent-only health promotion. Interventions were delivered during an all-day workshop. Assessments were completed at baseline and three months postintervention.
RESULTS


Compared with those in the health intervention, adolescents in the HIV prevention interventions reported fewer unsafe sex acts (adjusted rate ratio=.49, p=.01), greater condom use (adjusted relative change=59%, p=.01), and greater likelihood of avoiding sex (adjusted odds ratio=1.44, p=.05). They also showed improved HIV knowledge (p<.01) and self-efficacy (p<.05). The family-based intervention, compared with the other interventions, produced significant improvements in parent-teen sexual communication (p<.01), parental monitoring (p<.01), and parental permissiveness (p=.05).
CONCLUSIONS


This RCT found that the HIV prevention interventions reduced sexual risk behavior over three months in a large, diverse sample of youths in mental health treatment and that the family-based intervention improved parental monitoring and communication with teens about sex. These interventions show promise.",2014,"The family-based intervention, compared with the other interventions, produced significant improvements in parent-teen sexual communication (p<.01), parental monitoring (p<.01), and parental permissiveness (p=.05).
","['youths in mental health treatment', '721 adolescents (ages 13-18 years) and their caregivers from mental health settings in three U.S. cities']","['family-based and adolescent-only HIV prevention programs', 'structured group interventions: family-based HIV prevention, adolescent-only HIV prevention, and adolescent-only health promotion']","['likelihood of avoiding sex', 'parent-teen sexual communication (p<.01), parental monitoring (p<.01), and parental permissiveness', 'sexual risk behavior', 'HIV knowledge (p<.01) and self-efficacy', 'HIV risk and improving parental monitoring and sexual communication', 'unsafe sex acts']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0184647', 'cui_str': 'Mental health treatment'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}]","[{'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0031166'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0556482', 'cui_str': 'Unsafe Sex'}]",,0.0273969,"The family-based intervention, compared with the other interventions, produced significant improvements in parent-teen sexual communication (p<.01), parental monitoring (p<.01), and parental permissiveness (p=.05).
","[{'ForeName': 'Larry K', 'Initials': 'LK', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Hadley', 'Affiliation': ''}, {'ForeName': 'Geri R', 'Initials': 'GR', 'LastName': 'Donenberg', 'Affiliation': ''}, {'ForeName': 'Ralph J', 'Initials': 'RJ', 'LastName': 'DiClemente', 'Affiliation': ''}, {'ForeName': 'Celia', 'Initials': 'C', 'LastName': 'Lescano', 'Affiliation': ''}, {'ForeName': 'Delia M', 'Initials': 'DM', 'LastName': 'Lang', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Crosby', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Barker', 'Affiliation': ''}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Oster', 'Affiliation': ''}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.201300095']
1730,25024938,Effect of gamma-hydroxybutyrate on keratinocytes proliferation: A preliminary prospective controlled study in severe burn patients.,"BACKGROUND


Hypermetabolism and hyposomatotropism related to severe burns lead to impaired wound healing. Growth hormone (GH) boosts wound healing notably following stimulation of the production of insulin-like growth factor-1 (IGF1), a mitogen factor for keratinocytes. Gamma-hydroxybutyrate (GHB) stimulates endogenous GH secretion.
AIM


To assess effects of GHB sedation on keratinocytes proliferation (based on immunohistochemical techniques).
DESIGN


Monocentric, prospective, controlled trial.
MATERIALS AND METHODS


Patients (aging 18-65 years, burn surface area >30%, expected to be sedated for at least one month) were alternately allocated, at the 5(th) day following injury, in three groups according to the intravenous GHB dose administered for 21 days: Evening bolus of 50 mg/kg (Group B), continuous infusion at the rate of 10 mg/kg/h (Group C), or absence of GHB (Group P). They all received local standard cares. Immunohistochemistry (Ki67/MIB-1, Ulex europaeus agglutinin-1 and Mac 387 antibodies) was performed at D21 on adjacent unburned skin sample for assessing any keratinocyte activation. Serum IGF1 levels were measured at initiation and completion of the protocol.
STATISTICAL ANALYSIS


Categorical variables were compared with Chi-square test. Comparisons of medians were made using Kruskal-Wallis test. Post hoc analyses were performed using Mann-Whitney test with Bonferroni correction for multiple comparisons. A P < 0.05 was considered to be statistically significant.
RESULTS


A total of 14 patients completed the study (Group B: n = 5, Group C: n = 5, Group P: n = 4). Continuous administration of GHB was associated with a significant higher Ki67 immunolabeling at D21 (P = 0.049) and with a significant higher increase in the IGF1 concentrations at D21 (P = 0.024). No adverse effects were disclosed.
CONCLUSIONS


Our preliminary data support a positive effect of GHB on keratinocyte proliferation and are encouraging enough to warrant large prospective studies.",2014,Continuous administration of GHB was associated with a significant higher Ki67 immunolabeling at D21 (P = 0.049) and with a significant higher increase in the IGF1 concentrations at D21 (P = 0.024).,"['Patients (aging 18-65 years, burn surface area >30%, expected to be sedated for at least one month', '14 patients completed the study (Group B: n = 5, Group C: n = 5, Group P: n = 4', 'severe burn patients']","['Growth hormone (GH', 'GHB sedation', 'GHB', 'gamma-hydroxybutyrate', 'Gamma-hydroxybutyrate (GHB']","['adverse effects', 'IGF1 concentrations', 'keratinocytes proliferation', 'Serum IGF1 levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C4082115', 'cui_str': 'One month (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C0441849', 'cui_str': 'Group P (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]","[{'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0000503', 'cui_str': '4-Hydroxybutyrate (substance)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0334094', 'cui_str': 'Proliferation (morphologic abnormality)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",14.0,0.100025,Continuous administration of GHB was associated with a significant higher Ki67 immunolabeling at D21 (P = 0.049) and with a significant higher increase in the IGF1 concentrations at D21 (P = 0.024).,"[{'ForeName': 'Anne-Françoise', 'Initials': 'AF', 'LastName': 'Rousseau', 'Affiliation': 'Intensive Care Unit and Burn Centre, University Hospital, Liège, Belgium.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bargues', 'Affiliation': 'Burn Centre, Percy Military Teaching Hospital, Clamart, France.'}, {'ForeName': 'Hervé Le', 'Initials': 'HL', 'LastName': 'Bever', 'Affiliation': 'Burn Centre, Percy Military Teaching Hospital, Clamart, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Vest', 'Affiliation': 'Clinical Chemistry, Percy Military Teaching Hospital, Clamart, France.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Cavalier', 'Affiliation': 'Clinical Chemistry, University Hospital, Liège, France.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Ledoux', 'Affiliation': 'Intensive Care Unit and Burn Centre, University Hospital, Liège, Belgium.'}, {'ForeName': 'Gérald E', 'Initials': 'GE', 'LastName': 'Piérard', 'Affiliation': 'Dermatopathology, University Hospital, Liège, Belgium.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Damas', 'Affiliation': 'Intensive Care Unit and Burn Centre, University Hospital, Liège, Belgium.'}]",International journal of critical illness and injury science,['10.4103/2229-5151.134150']
1731,24999283,Identifying patients with problematic drug use in the emergency department: results of a multisite study.,"STUDY OBJECTIVE


Drug-related emergency department (ED) visits have steadily increased, with substance users relying heavily on the ED for medical care. The present study aims to identify clinical correlates of problematic drug use that would facilitate identification of ED patients in need of substance use treatment.
METHODS


Using previously validated tests, 15,224 adult ED patients across 6 academic institutions were prescreened for drug use as part of a large randomized prospective trial. Data for 3,240 participants who reported drug use in the past 30 days were included. Self-reported variables related to demographics, substance use, and ED visit were examined to determine their correlative value for problematic drug use.
RESULTS


Of the 3,240 patients, 2,084 (64.3%) met criteria for problematic drug use (Drug Abuse Screening Test score ≥ 3). Age greater than or equal to 30 years, tobacco smoking, daily or binge alcohol drinking, daily drug use, primary noncannabis drug use, resource-intense ED triage level, and perceived drug-relatedness of ED visit were highly correlated with problematic drug use. Among primary cannabis users, correlates of problematic drug use were age younger than 30 years, tobacco smoking, binge drinking, daily drug use, and perceived relatedness of the ED visit to drug use.
CONCLUSION


Clinical correlates of drug use problems may assist the identification of ED patients who would benefit from comprehensive screening, intervention, and referral to treatment. A clinical decision rule is proposed. The correlation between problematic drug use and resource-intense ED triage levels suggests that ED-based efforts to reduce the unmet need for substance use treatment may help decrease overall health care costs.",2014,"Among primary cannabis users, correlates of problematic drug use were age younger than 30 years, tobacco smoking, binge drinking, daily drug use, and perceived relatedness of the ED visit to drug use.
","['Identifying patients with problematic drug use in the emergency department', '3,240 participants who reported drug use in the past 30 days were included', 'ED patients who would benefit from comprehensive screening, intervention, and referral to treatment', 'Of the 3,240 patients, 2,084 (64.3%) met criteria for problematic drug use (Drug Abuse Screening Test score ≥ 3', 'primary cannabis users, correlates of problematic drug use were age younger than 30 years, tobacco smoking, binge drinking, daily drug use, and perceived relatedness of the ED visit to drug use', '15,224 adult ED patients across 6 academic institutions']",[],"['tobacco smoking, daily or binge alcohol drinking, daily drug use, primary noncannabis drug use, resource-intense ED triage level']","[{'cui': 'C1269815', 'cui_str': 'Patient identification'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0451130', 'cui_str': 'Drug abuse screening test (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]",[],"[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",15224.0,0.0486456,"Among primary cannabis users, correlates of problematic drug use were age younger than 30 years, tobacco smoking, binge drinking, daily drug use, and perceived relatedness of the ED visit to drug use.
","[{'ForeName': 'Wendy L', 'Initials': 'WL', 'LastName': 'Macias Konstantopoulos', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA; Harvard Medical School, Boston, MA. Electronic address: wmacias@mgh.harvard.edu.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Dreifuss', 'Affiliation': 'Department of Psychiatrys, Boston, MA; Harvard Medical School, Boston, MA; Behavioral Health Partial Program, McLean Hospital, Belmont, MA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'McDermott', 'Affiliation': 'Division of Alcohol and Drug Abuse, McLean Hospital, Belmont, MA.'}, {'ForeName': 'Blair Alden', 'Initials': 'BA', 'LastName': 'Parry', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Howell', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Raul N', 'Initials': 'RN', 'LastName': 'Mandler', 'Affiliation': 'Center for the Clinical Trials Network, National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Garrett M', 'Initials': 'GM', 'LastName': 'Fitzmaurice', 'Affiliation': 'Department of Biostatistics, Harvard School of Public Health, Boston, MA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Bogenschutz', 'Affiliation': 'Department of Psychiatry, University of New Mexico Health Sciences Center, Albuquerque, NM.'}, {'ForeName': 'Roger D', 'Initials': 'RD', 'LastName': 'Weiss', 'Affiliation': 'Department of Psychiatrys, Boston, MA; Harvard Medical School, Boston, MA; Division of Alcohol and Drug Abuse, McLean Hospital, Belmont, MA.'}]",Annals of emergency medicine,['10.1016/j.annemergmed.2014.05.012']
1732,24128381,Achieving smoking abstinence is associated with decreased cocaine use in cocaine-dependent patients receiving smoking-cessation treatment.,"BACKGROUND


Past research suggests that a significant relationship exists between cigarette smoking and illicit-stimulant abuse. The present study evaluated the association between achieving smoking abstinence in response to smoking-cessation treatment (SCT) and illicit-stimulant abstinence in cocaine- and/or methamphetamine-dependent participants.
METHODS


Secondary analysis of a randomized, 10-week trial conducted at 12 substance use disorder (SUD) treatment programs. Two hundred and sixty seven adults, meeting DSM-IV-TR criteria for cocaine and/or methamphetamine-dependence and interested in quitting smoking were randomized to SUD treatment as usual plus SCT consisting of weekly individual smoking cessation counseling, extended-release (XL) bupropion (300 mg/day), nicotine inhaler, and contingency management for smoking abstinence. Illicit-stimulant-abstinence was measured by self-report and urine drug screens. Smoking abstinence was assessed via self-report and carbon monoxide levels.
RESULTS


A significant effect was found for the cocaine-dependent subsample (N=147) in which participants who stopped smoking were abstinent for illicit stimulants an average of 78.2% of the post-smoking-quit weeks (weeks 4-10) relative to 63.6% in participants who continued smoking (X(2)(1)=8.55, p<.01, d=0.36). No significant effects were found for the sample as a whole (N=249) or for the methamphetamine-dependent subsample (N=102).
CONCLUSIONS


The present results suggest that cocaine-dependent patients achieving smoking abstinence in response to SCT might evidence not only improved smoking outcomes but improved cocaine-use outcomes as well. Future research to replicate this finding appears warranted.",2014,"No significant effects were found for the sample as a whole (N=249) or for the methamphetamine-dependent subsample (N=102).
","['dependent participants', '12 substance use disorder (SUD) treatment programs', 'Two hundred and sixty seven adults, meeting DSM-IV-TR criteria for cocaine and/or methamphetamine-dependence and interested in quitting smoking']","['methamphetamine', 'nicotine inhaler, and contingency management for smoking abstinence', 'SUD treatment as usual plus SCT consisting of weekly individual smoking cessation counseling, extended-release (XL) bupropion', 'smoking-cessation treatment (SCT) and illicit-stimulant abstinence in cocaine']","['Illicit-stimulant-abstinence', 'smoking outcomes', 'Smoking abstinence']","[{'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C1533217', 'cui_str': 'Methamphetamine dependence (disorder)'}, {'cui': 'C0543488', 'cui_str': 'Interested (finding)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C0814019', 'cui_str': 'Nicotine inhaler'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0332266', 'cui_str': 'Illicit (qualifier value)'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}]","[{'cui': 'C0332266', 'cui_str': 'Illicit (qualifier value)'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]",,0.0195245,"No significant effects were found for the sample as a whole (N=249) or for the methamphetamine-dependent subsample (N=102).
","[{'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Winhusen', 'Affiliation': 'Addiction Sciences Division, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3210 Jefferson Avenue, Cincinnati, OH 45220, USA. Electronic address: winhust@ucmail.uc.edu.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Kropp', 'Affiliation': 'Addiction Sciences Division, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3210 Jefferson Avenue, Cincinnati, OH 45220, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Theobald', 'Affiliation': 'Addiction Sciences Division, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3210 Jefferson Avenue, Cincinnati, OH 45220, USA.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Lewis', 'Affiliation': 'Addiction Sciences Division, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3210 Jefferson Avenue, Cincinnati, OH 45220, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2013.09.019']
1733,24075226,"A tale of two stimulants: mentholated cigarettes may play a role in cocaine, but not methamphetamine, dependence.","BACKGROUND


Research suggests that mentholated cigarettes may play a role in cocaine dependence. The purpose of the present study was to expand upon the research on mentholated cigarettes and cocaine dependence and to evaluate the role of mentholated cigarettes in methamphetamine dependence.
METHODS


Secondary analysis of a multisite, randomized trial evaluating the impact of smoking-cessation treatment in stimulant-dependent outpatients (N=538). Participants' reasons for concurrent use of cigarettes and illicit stimulants were assessed via self-report. Stimulant-abstinence was measured by self-report and urine drug screens. Smoking cessation was assessed via self-report and carbon monoxide levels.
RESULTS


Of the 301 cocaine-dependent participants, 201 (67%) were menthol and 100 (33%) were non-menthol cigarette smokers. Cocaine-dependent participants who smoked menthol, compared to non-menthol, cigarettes were significantly more likely to report that cigarettes prolong their cocaine high (X(2)(1)=16.3, p<.0001, OR=3.58 [95% CI: 1.88-6.79]) and were less likely to be stimulant abstinent during active treatment (W=3.6, p<0.001, d=.39 [95% CI: 0.16-0.62]), at 3-month follow-up (X(2)(1)=14.4, p<0.001, OR=.32 [95% CI: 0.17-0.58]), and at 6-month follow-up (X(2)(1)=4.6, p=0.03, OR=.53 [95% CI: 0.29-0.95]). No parallel differences were found between menthol and non-menthol methamphetamine-dependent smokers. The prevalence of Caucasian menthol smokers was significantly greater in the cocaine-dependent participants (37.2%) than in the methamphetamine-dependent participants (17.61%), (X(2)(1)=14.4, p<.001, OR=2.77 [95% CI:1.62-4.73]). Smoking cessation was not significantly associated with cigarette type for either cocaine- or methamphetamine-dependent participants.
CONCLUSIONS


The present results suggest that mentholated cigarettes play a role in cocaine, but not methamphetamine, dependence.",2013,"Cocaine-dependent participants who smoked menthol, compared to non-menthol, cigarettes were significantly more likely to report that cigarettes prolong their cocaine high (X(2)(1)=16.3, p<.0001, OR=3.58 [95% CI: 1.88-6.79]) and were less likely to be stimulant abstinent during active treatment (W=3.6, p<0.001, d=.39 [95% CI: 0.16-0.62]), at 3-month follow-up (X(2)(1)=14.4, p<0.001, OR=.32 [95% CI: 0.17-0.58]), and at 6-month follow-up (X(2)(1)=4.6, p=0.03, OR=.53 [95% CI: 0.29-0.95]).","['Of the 301 cocaine-dependent participants, 201 (67%) were menthol and 100 (33%) were non-menthol cigarette smokers', 'stimulant-dependent outpatients (N=538']","['Cocaine', 'smoking-cessation treatment']","['Smoking cessation', 'prevalence of Caucasian menthol smokers']","[{'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]",,0.0387282,"Cocaine-dependent participants who smoked menthol, compared to non-menthol, cigarettes were significantly more likely to report that cigarettes prolong their cocaine high (X(2)(1)=16.3, p<.0001, OR=3.58 [95% CI: 1.88-6.79]) and were less likely to be stimulant abstinent during active treatment (W=3.6, p<0.001, d=.39 [95% CI: 0.16-0.62]), at 3-month follow-up (X(2)(1)=14.4, p<0.001, OR=.32 [95% CI: 0.17-0.58]), and at 6-month follow-up (X(2)(1)=4.6, p=0.03, OR=.53 [95% CI: 0.29-0.95]).","[{'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Winhusen', 'Affiliation': 'Cincinnati Addiction Research Treatment and Education Center (CinARTEC), Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3210 Jefferson Avenue, Cincinnati, OH 45220, USA. Electronic address: winhusen@carc.uc.edu.'}, {'ForeName': 'Bryon', 'Initials': 'B', 'LastName': 'Adinoff', 'Affiliation': ''}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Brigham', 'Affiliation': ''}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Gardin', 'Affiliation': ''}, {'ForeName': 'Susan C', 'Initials': 'SC', 'LastName': 'Sonne', 'Affiliation': ''}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Theobald', 'Affiliation': ''}, {'ForeName': 'Udi', 'Initials': 'U', 'LastName': 'Ghitza', 'Affiliation': ''}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2013.09.002']
1734,32421612,Recovery from recurrent depression: Randomized controlled trial of the efficacy of mindfulness-based compassionate living compared with treatment-as-usual on depressive symptoms and its consolidation at longer term follow-up.,"INTRODUCTION


Mindfulness-Based Cognitive Therapy (MBCT) has been shown to reduce depressive symptoms in patients with recurrent or chronic depression. However, sequential, follow-up interventions are needed to further improve outcome for this group of patients. One possibility is to cultivate mechanisms thought to support recovery from depression, such as (self-)compassion. The current study examined the efficacy of mindfulness-based compassionate living (MBCL) in recurrently depressed patients who previously received MBCT, and consolidation effects of MBCL at follow-up.
METHODS


Part one is a randomized controlled trial (RCT) comparing MBCL in addition to treatment as usual (TAU) with TAU alone. The primary outcome measure was severity of depressive symptoms. Possible mediators and moderators of treatment outcome were examined. Part two is an uncontrolled study of both intervention- and control group on the consolidation of treatment effect of MBCL over the course of a 6-months follow-up period.
RESULTS


Patients were recruited between July 2013 and December 2014 (N = 122). MBCL participants (n = 61) showed significant improvements in depressive symptoms (Cohen's d = 0.35), compared to those who only received TAU (n = 61). The results at 6-months follow-up showed a continued improvement of depressive symptoms.
LIMITATIONS


As MBCL was not compared with an active control condition, we have little information about the possible effectiveness of non-specific factors.
CONCLUSION


MBCL appears to be effective in reducing depressive symptoms in a population suffering from severe, prolonged, recurrent depressive symptoms. To optimise the (sequential) treatment trajectory, replication of the study in a prospective sequential trial is needed. Registered at ClinicalTrials.gov:NCT02059200.",2020,"MBCL participants (n = 61) showed significant improvements in depressive symptoms (Cohen's d = 0.35), compared to those who only received TAU (n = 61).","['patients with recurrent or chronic depression', 'recurrent depression', 'recurrently depressed patients who previously received MBCT, and consolidation effects of MBCL at follow-up', 'Patients were recruited between July 2013 and December 2014 (N\xa0=\xa0122']","['MBCL', 'TAU', 'mindfulness-based compassionate living (MBCL', 'intervention', 'Mindfulness-Based Cognitive Therapy (MBCT', 'mindfulness-based compassionate living compared with treatment-as-usual']","['depressive symptoms', 'severity of depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0581391', 'cui_str': 'Chronic depression'}, {'cui': 'C0221480', 'cui_str': 'Recurrent depression'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0570495,"MBCL participants (n = 61) showed significant improvements in depressive symptoms (Cohen's d = 0.35), compared to those who only received TAU (n = 61).","[{'ForeName': 'Rhoda', 'Initials': 'R', 'LastName': 'Schuling', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Centre, Nijmegen, the Netherlands. Electronic address: rhoda.schuling@radboudumc.nl.'}, {'ForeName': 'Marloes J', 'Initials': 'MJ', 'LastName': 'Huijbers', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Hiske', 'Initials': 'H', 'LastName': 'van Ravesteijn', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Rogier', 'Initials': 'R', 'LastName': 'Donders', 'Affiliation': 'Department of Epidemiology, Biostatistics, and Health Technology Assessment, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Cillessen', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'Kuyken', 'Affiliation': 'Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, United Kingdom.'}, {'ForeName': 'Anne E M', 'Initials': 'AEM', 'LastName': 'Speckens', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Centre, Nijmegen, the Netherlands.'}]",Journal of affective disorders,['10.1016/j.jad.2020.03.182']
1735,23815427,Relationship of age to impulsivity and decision making: a baseline secondary analysis of a behavioral treatment study in stimulant use disorders.,"Because stimulant use disorders remain prevalent across the lifespan, cognition is an important area of clinical care and research focus among aging adults with stimulant use disorders. This secondary analysis of a National Institute on Drug Abuse Clinical Trials Network study suggests that decision making, verbal learning/memory, executive function, and set shifting are important cognitive domains to screen clinically and treat in aging adults with stimulant use disorders. Some suggestions are made on how clinical treatment providers can practically use these results. An important direction for future research is the development of cognitively remediating treatments for impaired cognitive domains in aging adults with stimulant use disorders.",2013,An important direction for future research is the development of cognitively remediating treatments for impaired cognitive domains in aging adults with stimulant use disorders.,['aging adults with stimulant use disorders'],[],[],"[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",[],[],,0.0209896,An important direction for future research is the development of cognitively remediating treatments for impaired cognitive domains in aging adults with stimulant use disorders.,"[{'ForeName': 'Raj K', 'Initials': 'RK', 'LastName': 'Kalapatapu', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, CA, USA. kalapatapu.raj.k@gmail.com'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Vinogradov', 'Affiliation': ''}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Batki', 'Affiliation': ''}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': ''}]",Journal of addictive diseases,['10.1080/10550887.2013.795471']
1736,23808868,"Preliminary evaluation of a model of stimulant use, oxidative damage and executive dysfunction.","BACKGROUND


Illicit stimulant use increases oxidative stress and oxidative stress has been found to be associated with deficits in memory, attention and problem-solving.
OBJECTIVE


To test a model of the association among oxidative DNA damage, a severe form of oxidative stress, and stimulant use, executive function and stimulant-use outcomes.
METHODS


Six sites evaluating 12-step facilitation for stimulant abusers obtained peripheral blood samples from methamphetamine-dependent (n = 45) and cocaine-dependent (n = 120) participants. The blood samples were submitted to a comet assay to assess oxidative DNA damage. Executive Dysfunction was assessed with the Frontal Systems Behavior Scale (FrSBe), which is a reliable and valid self-report assessment of executive dysfunction, disinhibition and apathy. Stimulant-use measures included self-reported stimulant use and stimulant urine drug screens (UDS).
RESULTS


While more recent cocaine use (<30 days abstinence) was associated with greater oxidative DNA damage (W = 2.4, p < 0.05, d = 0.36), the results did not support the hypothesized relationship between oxidative DNA damage, executive dysfunction and stimulant use outcomes for cocaine-dependent patients. Support for the model was found for methamphetamine-dependent patients, with oxidative DNA damage significantly greater in methamphetamine-dependent patients with executive dysfunction (W = 2.2, p < 0.05, d = 0.64) and with executive dysfunction being a significant mediator of oxidative DNA damage and stimulant use during active treatment (ab = 0.089, p < 0.05). As predicted, neither disinhibition nor apathy were significant mediators of oxidative damage and future stimulant use.
CONCLUSION


These findings provide preliminary support for a model in which oxidative damage resulting from methamphetamine use results in executive dysfunction, which in turn increases vulnerability to future stimulant use.",2013,"While more recent cocaine use (<30 days abstinence) was associated with greater oxidative DNA damage (W = 2.4, p < 0.05, d = 0.36), the results did not support the hypothesized relationship between oxidative DNA damage, executive dysfunction and stimulant use outcomes for cocaine-dependent patients.",['Six sites evaluating 12-step facilitation for stimulant abusers obtained peripheral blood samples from methamphetamine-dependent (n\u2009=\u200945) and cocaine-dependent (n\u2009=\u2009120) participants'],[],"['Frontal Systems Behavior Scale (FrSBe', 'Executive Dysfunction', 'oxidative damage and executive dysfunction', 'oxidative DNA damage']","[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0234112', 'cui_str': 'Facilitation, function (observable entity)'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]",[],"[{'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0222045'}, {'cui': 'C2748208', 'cui_str': 'Executive dysfunction'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0012860', 'cui_str': 'DNA Injury'}]",120.0,0.026922,"While more recent cocaine use (<30 days abstinence) was associated with greater oxidative DNA damage (W = 2.4, p < 0.05, d = 0.36), the results did not support the hypothesized relationship between oxidative DNA damage, executive dysfunction and stimulant use outcomes for cocaine-dependent patients.","[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA. winhusen@carc.uc.edu'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Walker', 'Affiliation': ''}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Brigham', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Somoza', 'Affiliation': ''}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Theobald', 'Affiliation': ''}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Somoza', 'Affiliation': ''}]",The American journal of drug and alcohol abuse,['10.3109/00952990.2013.798663']
1737,32096884,Self-Administered Acupressure for Caregivers of Older Family Members: A Randomized Controlled Trial.,"OBJECTIVE


To test whether self-administered acupressure reduces stress and stress-related symptoms in caregivers of older family members.
DESIGN


In this randomized, assessor-blind, controlled trial, 207 participants were randomized (1:1) to an acupressure intervention or a wait-list control group.
SETTING


Community centers in Hong Kong, China.
PARTICIPANTS


Primary caregivers of an older family member who screened positive for caregiver stress with symptoms of fatigue, insomnia, or depression.
INTERVENTION


The 8-week intervention comprised four training sessions on self-administered acupressure, two follow-up sessions for learning reinforcement, and daily self-practice of self-administered acupressure.
MEASUREMENTS


The primary outcome was caregiver stress (Caregiver Burden Inventory). Secondary outcomes included fatigue (Piper Fatigue Scale), insomnia (Pittsburgh Sleep Quality Index), depression (Patient Health Questionnaire), and health-related quality of life (QoL) (12-item Short-Form Health Survey version 2). An intention-to-treat analysis was adopted.
RESULTS


Of 207 participants, 201 completed the study. Caregiver stress in the intervention group was significantly lower than that in the control group after 8 weeks (difference = -8.12; 95% confidence interval [CI] = -13.20 to -3.04; P = .002) and at 12-week follow-up (difference = -8.52; 95% CI = -13.91 to -3.12; P = .002). The intervention group, relative to the control group, also had significantly improved secondary outcomes of fatigue (difference = -0.84; 95% CI = -1.59 to -0.08; P = .031), insomnia (difference = -1.34; 95% CI = -2.40 to -0.27; P = .014), depression (difference = -1.76; 95% CI = -3.30 to -0.23; P = .025), and physical health-related QoL (difference = 3.08; 95% CI = 0.28-5.88; P = .032) after 8 weeks.
CONCLUSION


Self-administered acupressure intervention significantly relieves self-reported caregiver stress and co-occurring symptoms in those caring for older family members. Further studies are needed to measure the symptoms objectively and to examine the clinical importance of the observed improvement in caregiver stress. J Am Geriatr Soc 68:1193-1201, 2020.",2020,Self-administered acupressure intervention significantly relieves self-reported caregiver stress and co-occurring symptoms in those caring for older family members.,"['207 participants were randomized (1:1) to an', 'Caregivers of Older Family Members', 'Community centers in Hong Kong, China', '207 participants', 'Primary caregivers of an older family member who screened positive for caregiver stress with symptoms of fatigue, insomnia, or depression', 'caregivers of older family members']","['Self-Administered Acupressure', 'acupressure intervention or a wait-list control group', 'Self-administered acupressure intervention', 'training sessions on self-administered acupressure, two follow-up sessions for learning reinforcement, and daily self-practice of self-administered acupressure', 'self-administered acupressure']","['caregiver stress (Caregiver Burden Inventory', 'fatigue (Piper Fatigue Scale), insomnia (Pittsburgh Sleep Quality Index), depression (Patient Health Questionnaire), and health-related quality of life (QoL) (12-item Short-Form Health Survey version 2', 'physical health-related QoL', 'self-reported caregiver stress and co-occurring symptoms', 'secondary outcomes of fatigue', 'insomnia', 'depression', 'Caregiver stress']","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0035007', 'cui_str': 'Reinforcement'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0330232', 'cui_str': 'Piper'}, {'cui': 'C0222045'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",207.0,0.211079,Self-administered acupressure intervention significantly relieves self-reported caregiver stress and co-occurring symptoms in those caring for older family members.,"[{'ForeName': 'Denise Shuk Ting', 'Initials': 'DST', 'LastName': 'Cheung', 'Affiliation': 'School of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Tiwari', 'Affiliation': 'School of Nursing, Hong Kong Sanatorium and Hospital, Hong Kong, China.'}, {'ForeName': 'Wing-Fai', 'Initials': 'WF', 'LastName': 'Yeung', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Doris Sau Fung', 'Initials': 'DSF', 'LastName': 'Yu', 'Affiliation': 'School of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Mike Ka Pui', 'Initials': 'MKP', 'LastName': 'So', 'Affiliation': 'Department of Information Systems, Business Statistics and Operations Management, Hong Kong University of Science and Technology, Hong Kong, China.'}, {'ForeName': 'Pui Hing', 'Initials': 'PH', 'LastName': 'Chau', 'Affiliation': 'School of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Xiao-Min', 'Initials': 'XM', 'LastName': 'Wang', 'Affiliation': 'Department of Anaesthesiology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Terry Yat Sang', 'Initials': 'TYS', 'LastName': 'Lum', 'Affiliation': 'Department of Social Work and Social Administration, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Helina Yin King', 'Initials': 'HYK', 'LastName': 'Yuk Fung', 'Affiliation': 'Hong Kong Sheng Kung Hui Lady MacLehose Centre, Hong Kong, China.'}, {'ForeName': 'Benson Yuk Ming', 'Initials': 'BYM', 'LastName': 'Ng', 'Affiliation': 'Hong Kong Sheng Kung Hui Lady MacLehose Centre, Hong Kong, China.'}, {'ForeName': 'Zhang-Jin', 'Initials': 'ZJ', 'LastName': 'Zhang', 'Affiliation': 'School of Chinese Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Lixing', 'Initials': 'L', 'LastName': 'Lao', 'Affiliation': 'School of Chinese Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16357']
1738,32421603,Efficacy and cost-effectiveness of intensive short-term dynamic psychotherapy for treatment resistant depression: 18-Month follow-up of the Halifax depression trial.,"BACKGROUND


Depressed patients with chronic and complex health issues commonly relapse; therefore, examining longer-term outcomes is an important consideration. For treatment resistant depression (TRD), the post-treatment efficacy of time-limited Intensive Short-Term Dynamic Psychotherapy (ISTDP) has been demonstrated but longer-term outcomes and cost-effectiveness are unclear.
METHOD


In this superiority trial, 60 patients referred to Community Mental Health Teams (CMHT) were randomised to 2 groups (ISTDP=30 and CMHT=30). The primary outcome was Hamilton Depression Rating scale (HAM-D) scores at 18 months. Secondary outcomes included Patient Health Questionnaire (PHQ-9) depression scores and dichotomous measure remission. A health economic evaluation examined mental health costs with quality-adjusted life years (QALYs).
RESULTS


Statistically significant treatment differences in depression previously found at 6 months favouring ISTDP were maintained at 18-month follow-up. Group differences in depression were in the moderate to large range on both the observer rated (Cohen's d = .64) and self-report measures (Cohen's d = .70). At 18 months follow-up the remission rate in ISTDP patients was 40.0%, and 23.4% had discontinued antidepressants. Health economic analysis suggests that ISTDP was more cost-effective than CMHT at 18 months. Probabilistic analysis suggests that there is a 64.5% probability of ISTDP being cost-effective at a willingness to pay for a QALY of $25,000 compared to CMHT at 18 months.
LIMITATIONS


Replication of these findings is necessary in larger samples and future cost analyses should also consider indirect costs.
CONCLUSIONS


ISTDP demonstrates long-term efficacy and cost-effectiveness in TRD.",2020,Statistically significant treatment differences in depression previously found at 6 months favouring ISTDP were maintained at 18-month follow-up.,['60 patients referred to Community Mental Health Teams (CMHT'],"['ISTDP', 'intensive short-term dynamic psychotherapy', 'time-limited Intensive Short-Term Dynamic Psychotherapy (ISTDP']","['Hamilton Depression Rating scale (HAM-D) scores', 'Efficacy and cost-effectiveness', 'Patient Health Questionnaire (PHQ-9) depression scores and dichotomous measure remission', 'remission rate', 'depression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0332186', 'cui_str': 'Definite time'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",60.0,0.0697056,Statistically significant treatment differences in depression previously found at 6 months favouring ISTDP were maintained at 18-month follow-up.,"[{'ForeName': 'Joel M', 'Initials': 'JM', 'LastName': 'Town', 'Affiliation': 'Department of Psychiatry, Dalhousie University, Halifax, Canada. Electronic address: joel.town@dal.ca.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Abbass', 'Affiliation': 'Department of Psychiatry, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Stride', 'Affiliation': 'The Institute of Work Psychology, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Nunes', 'Affiliation': 'Department of Psychiatry & Faculty of Computer Science, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Bernier', 'Affiliation': 'Department of Psychiatry, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Berrigan', 'Affiliation': 'Research Methods Unit, Nova Scotia Health Authority, Halifax, Canada.'}]",Journal of affective disorders,['10.1016/j.jad.2020.04.035']
1739,32002556,Final report from Intergroup NCCTG 86-72-51 (Alliance): a phase III randomized clinical trial of high-dose versus low-dose radiation for adult low-grade glioma.,"BACKGROUND


The optimal radiation dose for adult supratentorial low-grade glioma is unknown. The aim of this study was to provide a final update on oncologic and cognitive outcomes of high-dose versus low-dose radiation for low-grade glioma.
METHODS


Between 1986 and 1994, 203 patients with supratentorial low-grade glioma were randomized (1:1) to 50.4 Gy in 28 fractions versus 64.8 Gy in 36 fractions after any degree of resection.
RESULTS


For all patients, median overall survival (OS) was 8.4 years (95% CI: 7.2-10.8). Median progression-free survival (PFS) was 5.2 years (95% CI: 4.3-6.6). Median follow-up is 17.2 years for the 33 patients still alive. High-dose radiation did not improve 15-year OS (22.4%) versus low-dose radiation (24.9%, log-rank P = 0.978) or 15-year PFS (high dose, 15.2% vs low dose, 9.5%; P = 0.7142). OS was significantly better for patients with preoperative tumor diameter <5 cm and baseline Mini-Mental State Examination (MMSE) >27 and who underwent gross total resection. PFS was improved for patients with oligodendroglioma versus astrocytoma, preoperative tumor diameter <5 cm, patients who had gross total resection, and patients with baseline MMSE >27. For patients who had normal MMSE at baseline, at 7 years only 1 patient (5%) had a clinically significant decrease in MMSE from the previous time point, with the remainder (95%) stable. None had decrease in MMSE at 10, 12, or 15 years.
CONCLUSIONS


Long-term follow-up indicates no benefit to high-dose over low-dose radiation for low-grade gliomas. Cognitive function appeared to be stable after radiation as measured by MMSE.",2020,Median progression-free survival (PFS) was 5.2 years (95% CI: 4.3 - 6.6).,"['adult low-grade glioma', 'Between 1986 and 1994', '203 patients with supratentorial low grade glioma', 'adult supratentorial low grade glioma']",[],"['Median progression-free survival (PFS', 'median OS', 'Cognitive function']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1997217', 'cui_str': 'Low grade glioma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441938', 'cui_str': 'Supratentorial (qualifier value)'}]",[],"[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}]",203.0,0.086495,Median progression-free survival (PFS) was 5.2 years (95% CI: 4.3 - 6.6).,"[{'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Breen', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'S Keith', 'Initials': 'SK', 'LastName': 'Anderson', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Xiomara W', 'Initials': 'XW', 'LastName': 'Carrero', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Brown', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Karla V', 'Initials': 'KV', 'LastName': 'Ballman', 'Affiliation': 'Weill Medical College of Cornell University, New York, New York.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': ""O'Neill"", 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Walter J', 'Initials': 'WJ', 'LastName': 'Curran', 'Affiliation': 'Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Ross A', 'Initials': 'RA', 'LastName': 'Abrams', 'Affiliation': 'Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Nadia N', 'Initials': 'NN', 'LastName': 'Laack', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Levitt', 'Affiliation': 'Fargo Clinic, North Fargo, North Dakota.'}, {'ForeName': 'Evanthia', 'Initials': 'E', 'LastName': 'Galanis', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jan C', 'Initials': 'JC', 'LastName': 'Buckner', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Edward G', 'Initials': 'EG', 'LastName': 'Shaw', 'Affiliation': 'Wake Forest Baptist Health, Winston-Salem, North Carolina.'}]",Neuro-oncology,['10.1093/neuonc/noaa021']
1740,23158229,Effects of maternal worm infections and anthelminthic treatment during pregnancy on infant motor and neurocognitive functioning.,"We tested the hypothesis that maternal worm infections in pregnancy affect infant motor and neurocognitive development, and that anthelminthic treatment during pregnancy can reverse these effects. We used measures which examine infant motor, cognitive and executive function, including inhibition. We assessed 983 Ugandan infants aged 15 months, using locally appropriate measures within the Entebbe Mother and Baby Study, a trial of anthelminthic treatment during pregnancy. Key exposures were maternal worm infections and anthelminthic treatment during pregnancy. Effects of other health and social factors were controlled for statistically. Of the five major worm species found in the pregnant women, two had influences on the developmental measures: Maternal Mansonella perstans and Strongyloides stercoralis infections showed negative associations with the A-not B-task, and Language, respectively. Performance on other psychomotor and cognitive measures was associated with illnesses during infancy and infants' behavior during assessment, but not with maternal worm infections. There were no positive effects of maternal anthelminthic treatment on infant abilities. Mansonella perstans and Strongyloides stercoralis infection during pregnancy seem associated with impaired early executive function and language, respectively, but single-dose anthelminthic treatment during pregnancy was not beneficial. The biological mechanisms that could underlie these neurocognitive effects are discussed.",2012,"Mansonella perstans and Strongyloides stercoralis infection during pregnancy seem associated with impaired early executive function and language, respectively, but single-dose anthelminthic treatment during pregnancy was not beneficial.","['983 Ugandan infants aged 15 months, using locally appropriate measures within the Entebbe Mother and Baby Study, a trial of anthelminthic treatment during pregnancy']",[],['infant motor and neurocognitive functioning'],"[{'cui': 'C0241520', 'cui_str': 'Ugandans (ethnic group)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]",[],"[{'cui': 'C0021270', 'cui_str': 'Infant'}]",983.0,0.0272125,"Mansonella perstans and Strongyloides stercoralis infection during pregnancy seem associated with impaired early executive function and language, respectively, but single-dose anthelminthic treatment during pregnancy was not beneficial.","[{'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Nampijja', 'Affiliation': 'Co-infections Studies Programme, MRC/UVRI Uganda Research Unit on AIDS, Entebbe, Uganda. m.nampijja@lancaster.ac.uk'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Apule', 'Affiliation': ''}, {'ForeName': 'Swaib', 'Initials': 'S', 'LastName': 'Lule', 'Affiliation': ''}, {'ForeName': 'Hellen', 'Initials': 'H', 'LastName': 'Akurut', 'Affiliation': ''}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Muhangi', 'Affiliation': ''}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Webb', 'Affiliation': ''}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Elliott', 'Affiliation': ''}, {'ForeName': 'Katie J', 'Initials': 'KJ', 'LastName': 'Alcock', 'Affiliation': ''}]",Journal of the International Neuropsychological Society : JINS,['10.1017/S1355617712000768']
1741,23234408,Effect of different types of dietary fatty acids on subclinical inflammation in humans.,"Replacing SAFAs (saturated fatty acids) for vegetable PUFAs (polyunsaturated fatty acids) has a well documented positive effect on the lipoprotein pattern while the direct effect of dietary fatty acids composition on systemic inflammation remains to be proven. In well controlled randomised cross-over study with 15 overweight/obese postmenopausal women, the effect of dietary switch on systemic inflammation was investigated. A two 3 weeks dietary period either with predominant animal fat (SAFA, 29 caloric % SAFA) or vegetable fat (PUFA 25 % caloric % PUFA) were interrupted by wash-out period. The expected increasing effect on SAFA diet to LDL-C (low density cholesterol) and opposite effect of PUFA diet was documented following changes in fatty acid spectrum in VLDL (very low density cholesterol) particles. The switch from SAFA diet to PUFA diet produced a significant change of CRP (C-reactive protein) concentration (p<0.01) whereas similar trend of IL-18 did not reach statistical significance. In this study, previous in vitro results of different SAFA and PUFA proinflammatory effects with well documented molecular mechanisms were first proven in a clinical study. It could be stated that the substantial change of dietary fatty acid composition might influence proinflammatory effect in addition to traditional cardiovascular risk factors.",2013,The switch from SAFA diet to PUFA diet produced a significant change of CRP (C-reactive protein) concentration (p<0.01) whereas similar trend of IL-18 did not reach statistical significance.,"['15 overweight/obese postmenopausal women', 'subclinical inflammation in humans']","['predominant animal fat (SAFA, 29 caloric % SAFA) or vegetable fat (PUFA 25 % caloric % PUFA', 'Replacing SAFAs (saturated fatty acids) for vegetable PUFAs (polyunsaturated fatty acids', 'dietary fatty acids']",['CRP (C-reactive protein) concentration'],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205211', 'cui_str': 'Subclinical (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0301429', 'cui_str': 'Animal fat (substance)'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0597423', 'cui_str': 'Fatty Acids, Saturated'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}]","[{'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",15.0,0.0478747,The switch from SAFA diet to PUFA diet produced a significant change of CRP (C-reactive protein) concentration (p<0.01) whereas similar trend of IL-18 did not reach statistical significance.,"[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Králová Lesná', 'Affiliation': 'Institute for Clinical and Experimental Medicine, Prague, Czech Republic. ivka@ikem.cz'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Suchánek', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Brabcová', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kovář', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Malínská', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Poledne', 'Affiliation': ''}]",Physiological research,[]
1742,32060651,A study of susceptibility-weighted imaging in patients with Wilson disease during the treatment of metal chelator.,"OBJECTIVE


A randomized-controlled trial comparing study of the changes in brain sensitive-weighted imaging (SWI) of Wilson disease (WD) patients during the treatment with metal chelator was done.
METHODS


100 untreated WD patients (80 cases of cerebral type, 20 cases of hepatic type, age 20.13 ± 9.12 years old) and 20 normal controls were selected. Neurological symptoms were scored using the modified Young scale. Liver function tests and copper indices were collected. All study objects received SWI test of the brain. The values of corrected phase (CP) were calculated on SWI. Cerebral-type WD patients were treated with D-penicillamine (DPA) (group 1) or Dimercaptopropane Sulfonate (DMPS) + Dimercaptosuccinic Acid (DMSA) (group 2). Hepatic-type WD patients were treated with DPA (group 3). All patients received annual neurological symptom score, liver function, copper indices, and SWI examination.
RESULTS


At the first year of treatment, score of the modified Young scale in group 2 was lower than that in group 1 (P = 0.023) and lower than that before treatment (P = 0.040). After 2 years of treatment, the score of the modified Young scale in group 1 was lower than that before treatment (P = 0.012). At the second year after treatment, the urinary copper in group 2 was higher than that in group 1 (P = 0.014). Urinary copper was maintained at 200 µg/day in group 1 and 300 µg/day in group 2 after 3 years of treatment. At the first year of treatment, serum copper in group 1 was lower than that in group 2 (P = 0.032). At the first year of treatment, CP values of the pallidum and substantia nigra in group 2 were higher than those in group 1 (P = 0.026, 0.040). At the second year of treatment, CP value of substantia nigra in group 2 was higher than that in group 1 (P = 0.037). After 3 years of treatment, there was no difference in CP values between WD patients and normal controls.
CONCLUSIONS


Therapy with DMPS and DMSA improves neurological symptoms of WD patients more quickly and leads to less aggravation, compared with therapy with DPA. The metal content in the brain of WD patients was at a low level after 3 years of treatment. DMPS and DMSA can remove metal from brain tissue faster than DPA.",2020,"At the first year of treatment, score of the modified Young scale in group 2 was lower than that in group 1 (P = 0.023) and lower than that before treatment (P = 0.040).","['Hepatic-type WD patients', '100 untreated WD patients (80 cases of cerebral type, 20 cases of hepatic type, age 20.13\u2009±\u20099.12\xa0years old) and 20 normal controls were selected', 'patients with Wilson disease during the treatment of metal chelator']","['DMPS and DMSA', 'D-penicillamine (DPA', 'Dimercaptopropane Sulfonate (DMPS)\u2009+\u2009Dimercaptosuccinic Acid (DMSA', 'DPA']","['annual neurological symptom score, liver function, copper indices, and SWI examination', 'score of the modified Young scale', 'Urinary copper', 'CP value of substantia nigra', 'values of corrected phase (CP', 'neurological symptoms', 'serum copper', 'urinary copper', 'CP values', 'Liver function tests and copper indices', 'Neurological symptoms', 'CP values of the pallidum and substantia nigra']","[{'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0019202', 'cui_str': 'Pseudosclerosis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1289927', 'cui_str': 'Metal (material)'}, {'cui': 'C0007974', 'cui_str': 'Complexons'}]","[{'cui': 'C0041738', 'cui_str': 'Unithiol'}, {'cui': 'C0012384', 'cui_str': 'meso-2,3-dimercaptosuccinic acid'}, {'cui': 'C0030817', 'cui_str': 'Penicillamine'}, {'cui': 'C1875873', 'cui_str': '2,3-Dimercaptosuccinic Acid'}]","[{'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0235031', 'cui_str': 'Neurologic Symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0373587', 'cui_str': 'Copper measurement (procedure)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0038590', 'cui_str': 'Substantia Nigra'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0858105', 'cui_str': 'Serum copper'}, {'cui': 'C0023901', 'cui_str': 'Liver Function Tests'}, {'cui': 'C0017651', 'cui_str': 'Pallidum'}]",100.0,0.0177,"At the first year of treatment, score of the modified Young scale in group 2 was lower than that in group 1 (P = 0.023) and lower than that before treatment (P = 0.040).","[{'ForeName': 'Xiangxue', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, National Key Clinical Department and Key Discipline of Neurology, Guangdong Provincial Key Laboratory for Diagnosis and Treatment of Major Neurological Diseases, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China. 1397880617@qq.com.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'Department of Neurology, National Key Clinical Department and Key Discipline of Neurology, Guangdong Provincial Key Laboratory for Diagnosis and Treatment of Major Neurological Diseases, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xun-Hua', 'Initials': 'XH', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, National Key Clinical Department and Key Discipline of Neurology, Guangdong Provincial Key Laboratory for Diagnosis and Treatment of Major Neurological Diseases, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Hao-Ling', 'Initials': 'HL', 'LastName': 'Qin', 'Affiliation': 'Department of Neurology, National Key Clinical Department and Key Discipline of Neurology, Guangdong Provincial Key Laboratory for Diagnosis and Treatment of Major Neurological Diseases, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xiao-Yong', 'Initials': 'XY', 'LastName': 'Pu', 'Affiliation': 'Department of Neurology, National Key Clinical Department and Key Discipline of Neurology, Guangdong Provincial Key Laboratory for Diagnosis and Treatment of Major Neurological Diseases, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Ding-Bang', 'Initials': 'DB', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, National Key Clinical Department and Key Discipline of Neurology, Guangdong Provincial Key Laboratory for Diagnosis and Treatment of Major Neurological Diseases, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, National Key Clinical Department and Key Discipline of Neurology, Guangdong Provincial Key Laboratory for Diagnosis and Treatment of Major Neurological Diseases, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': 'Department of Neurology, National Key Clinical Department and Key Discipline of Neurology, Guangdong Provincial Key Laboratory for Diagnosis and Treatment of Major Neurological Diseases, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xiu-Ling', 'Initials': 'XL', 'LastName': 'Liang', 'Affiliation': 'Department of Neurology, National Key Clinical Department and Key Discipline of Neurology, Guangdong Provincial Key Laboratory for Diagnosis and Treatment of Major Neurological Diseases, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}]",Journal of neurology,['10.1007/s00415-020-09746-y']
1743,23305820,Impulsivity is associated with treatment non-completion in cocaine- and methamphetamine-dependent patients but differs in nature as a function of stimulant-dependence diagnosis.,"Greater impulsivity, assessed by the Barratt Impulsiveness Scale-11 (BIS-11) and Stroop interference scores, has been associated with treatment completion in cocaine-dependent patients. This study evaluated the relationships among impulsivity, stimulant-dependence diagnosis, and treatment completion. Six sites evaluating 12-step facilitation for stimulant abusers obtained the BIS-11 and Stroop from 182 methamphetamine- and/or cocaine-dependent participants. Methamphetamine-dependent, relative to cocaine-dependent, participants evidenced significantly greater BIS-11 non-planning and total scores. There was a trend for poorer response inhibition, measured by the Stroop, in cocaine-dependent, relative to methamphetamine-dependent, participants. Accounting for other factors related to treatment completion, BIS-11 motor score, assessing the tendency to act without thinking, predicted treatment completion for both cocaine-dependent and methamphetamine-dependent patients. These results suggest that methamphetamine-dependent and cocaine-dependent patients may have different impulsivity profiles but that the BIS-11 may be useful in identifying both methamphetamine-dependent and cocaine-dependent patients who are at risk for treatment non-completion.",2013,"There was a trend for poorer response inhibition, measured by the Stroop, in cocaine-dependent, relative to methamphetamine-dependent, participants.",['stimulant abusers obtained the BIS-11 and Stroop from 182 methamphetamine- and/or cocaine-dependent participants'],"['methamphetamine', 'Methamphetamine']","['Greater impulsivity', 'Impulsivity', 'poorer response inhibition', 'BIS-11 non-planning and total scores', 'Barratt Impulsiveness Scale-11 (BIS-11) and Stroop interference scores']","[{'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C1872096', 'cui_str': 'bis(phenylacetylarginine)'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}]","[{'cui': 'C0025611', 'cui_str': 'metamfetamine'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0021125', 'cui_str': 'Impulsivity'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C1872096', 'cui_str': 'bis(phenylacetylarginine)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character (finding)'}, {'cui': 'C0222045'}]",,0.0299686,"There was a trend for poorer response inhibition, measured by the Stroop, in cocaine-dependent, relative to methamphetamine-dependent, participants.","[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, OH 45220, USA. winhusen@carc.uc.edu'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'Bryon', 'Initials': 'B', 'LastName': 'Adinoff', 'Affiliation': ''}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Brigham', 'Affiliation': ''}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Kropp', 'Affiliation': ''}, {'ForeName': 'Dennis M', 'Initials': 'DM', 'LastName': 'Donovan', 'Affiliation': ''}, {'ForeName': 'Cindy L', 'Initials': 'CL', 'LastName': 'Seamans', 'Affiliation': ''}, {'ForeName': 'Candace C', 'Initials': 'CC', 'LastName': 'Hodgkins', 'Affiliation': ''}, {'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Dicenzo', 'Affiliation': ''}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Botero', 'Affiliation': ''}, {'ForeName': 'Davina R', 'Initials': 'DR', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Somoza', 'Affiliation': ''}]",Journal of substance abuse treatment,['10.1016/j.jsat.2012.12.005']
1744,23234418,Orally administered whey proteins have comparable effect on C-peptide secretion in healthy subjects as standard C-peptide stimulation tests.,"Our study compared total C-peptide secretion after administration of whey proteins and whey proteins in combination with glucose with results of classical tests assessing beta cell function in the pancreas of healthy individuals. Eight young, healthy (7 males, 1 female; aged 20-26 years), non-obese (BMI: 17-25.9 kg/m²) participants with normal glucose tolerance underwent six C-peptide secretion tests. Three secretion tests measured C-peptide response to orally administered substances: whey proteins only (OWT), whey proteins with glucose (OWGT) and glucose only (OGTT); while three secretion tests measured C-peptide response to intravenously administered substances: arginine (AST), glucagon (GST) and glucose (IVGTT). OWT stimulated a greater (93 %, p<0.05) C-peptide response than AST and a 64 % smaller response (p<0.05) than OGTT. OWT also showed lower variability (p<0.05) in C-peptide responses compared to OWGT and OGTT. The greatest total C-peptide response was induced by OWGT (36 % higher than glucose). OWT consistently increased C-peptide concentrations with lower individual variability, while insignificantly increasing glucose levels. Results of this study suggest that both dietology and beta-cells capacity testing could take advantage of the unique property of whey proteins to induce C-peptide secretion.",2013,"OWT stimulated a greater (93 %, p<0.05) C-peptide response than AST and a 64 % smaller response (p<0.05) than OGTT.","['Eight young, healthy (7 males, 1 female; aged 20-26 years), non-obese (BMI: 17-25.9 kg/m²) participants with normal glucose tolerance underwent six C-peptide secretion tests', 'healthy subjects', 'pancreas of healthy individuals']","['substances: arginine (AST), glucagon (GST) and glucose (IVGTT']","['greatest total C-peptide response', 'glucose levels', 'C-peptide secretion']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030274', 'cui_str': 'Pancreas'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0968133', 'cui_str': 'alpha-(trifluoromethyl)arginine'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}]",,0.0273331,"OWT stimulated a greater (93 %, p<0.05) C-peptide response than AST and a 64 % smaller response (p<0.05) than OGTT.","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Wildová', 'Affiliation': 'Center for Research of Diabetes, Metabolism and Nutrition, Prague, Czech Republic. elena.wildova@lf3.cuni.cz'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Dlouhý', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Kraml', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Rambousková', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Smejkalová', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Potočková', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Anděl', 'Affiliation': ''}]",Physiological research,[]
1745,32422538,Short- and long-term changes in substance-related coping as mediators of in-person and computerized CBT for alcohol and drug use disorders.,"BACKGROUND


No studies have examined long-term changes in substance-related coping skills as a statistical mediator of cognitive-behavioral therapy (CBT) for substance use disorders (SUD).
METHODS


We tested both short- and long-term changes in coping as mediators of treatment effects in two trials of in-person and/or computerized CBT for SUD. The first trial included 137 individuals (75 % male; 65.7 % non-White; mean age = 35.9) with drug and/or alcohol use disorders randomized to one of the following: in-person CBT, computer-delivered CBT (CBT4CBT) plus brief monitoring, or treatment-as-usual (TAU). The second trial included 68 individuals (65 % male; 66.2 % non-white; mean age = 42.7) with an alcohol use disorder randomized to one of the following: CBT4CBT plus brief monitoring, CBT4CBT plus TAU, or TAU only. Coping was assessed with the Coping Strategies Scale. Latent growth curve mediational models were conducted, with both short-term (baseline through end-of-treatment) and long-term (baseline through 3-month post-treatment follow-up) changes in coping.
RESULTS


There were no mediation effects for short-term changes in coping. However, in both trials, there were significant mediation effects for long-term changes in coping: In trial 1, the effect of CBT4CBT vs. TAU on substance use at the 6-month follow-up was mediated by long-term increases in coping. This same mediation effect was not found for in-person CBT vs. TAU. In trial 2, the effect of CBT4CBT vs. not receiving CBT4CBT on heavy drinking at the 6-month follow-up was mediated by long-term increases in coping.
CONCLUSIONS


Long-term increases in coping may be a mechanism of change in computerized CBT for SUD.",2020,This same mediation effect was not found for in-person CBT vs. TAU.,"['68 individuals (65 % male; 66.2 % non-white; mean age = 42.7) with an alcohol use disorder randomized to one of the following', 'two trials of in-person and/or computerized CBT for SUD', '137 individuals (75 % male; 65.7 % non-White; mean age = 35.9) with drug and/or alcohol use disorders randomized to one of the following: in']","['CBT4CBT vs. TAU', 'CBT4CBT vs. not receiving CBT4CBT', 'person CBT, computer-delivered CBT (CBT4CBT) plus brief monitoring, or treatment-as-usual (TAU']","['coping', 'heavy drinking']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1998288', 'cui_str': 'Computerized cognitive behavioral therapy'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]",137.0,0.0462548,This same mediation effect was not found for in-person CBT vs. TAU.,"[{'ForeName': 'Corey R', 'Initials': 'CR', 'LastName': 'Roos', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, 06510, United States. Electronic address: corey.roos@yale.edu.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Carroll', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, 06510, United States.'}, {'ForeName': 'Charla', 'Initials': 'C', 'LastName': 'Nich', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, 06510, United States.'}, {'ForeName': 'Tami', 'Initials': 'T', 'LastName': 'Frankforter', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, 06510, United States.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Kiluk', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, 06510, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108044']
1746,32421593,Familial severe psychiatric history in bipolar disorder and correlation with disease severity and treatment response.,"BACKGROUND


Bipolar disorder is a heritable disorder, and we aimed to assess the impact of family history of mental disorders in first-degree relatives on the severity and course of bipolar disorder.
METHODS


The Bipolar CHOICE (lithium versus quetiapine) and LiTMUS (optimized treatment with versus without lithium) comparative effectiveness studies were similar trials among bipolar disorder outpatients studying four different randomized treatment arms for 24 weeks. Patients self-reported on six severe mental disorders among first-degree relatives. We performed ANOVA and linear regression regarding disease severity measures, sociodemographic and cardiometabolic markers and mixed effects linear regression to evaluate treatment response.
RESULTS


Among 757 patients, 644 (85.1%) reported at least one first-degree relative with a severe mental disorder (mean=2.8; standard deviation=2.2; range=0-13). Depression (67.1%), alcohol abuse (51.0%) and bipolar disorder (47.0%) were the most frequently reported disorders. Familial psychiatric history correlated with several disease severity measures (hospitalizations, suicide attempts, and earlier onset) and sociodemographic markers (lower education and household income) but not with cardiometabolic markers (e.g. cholesterol or waist circumference) or cardiovascular risk scores, e.g. the Framingham risk score. Patients with familial psychiatric history tended to require more psychopharmacological treatment (p=0.054) but responded similarly (all p>0.1) to all four treatment arms.
CONCLUSIONS


Our findings indicate that familial psychiatric history is common among outpatients with bipolar disorder and correlates with disease severity and sociodemographic measures. Patients with a greater familial psychiatric load required more intense treatment but achieved similar treatment responses compared to patients without familial psychiatric history.",2020,Patients with a greater familial psychiatric load required more intense treatment but achieved similar treatment responses compared to patients without familial psychiatric history.,"['Patients with familial psychiatric history', 'bipolar disorder outpatients', 'outpatients with bipolar disorder']",['Bipolar CHOICE (lithium versus quetiapine) and LiTMUS (optimized treatment with versus without lithium'],"['severe mental disorder', 'Depression', 'cardiometabolic markers (e.g. cholesterol or waist circumference) or cardiovascular risk scores, e.g. the Framingham risk score', 'bipolar disorder', 'alcohol abuse']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0023870', 'cui_str': 'Lithium'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4046029', 'cui_str': 'Mental Disorders, Severe'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0085762', 'cui_str': 'Alcohol abuse'}]",757.0,0.044469,Patients with a greater familial psychiatric load required more intense treatment but achieved similar treatment responses compared to patients without familial psychiatric history.,"[{'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Köhler-Forsberg', 'Affiliation': 'Psychosis Research Unit, Aarhus University Hospital Psychiatry, Denmark; Department of Clinical Medicin, Aarhus University, Aarhus, Denmark; Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA. Electronic address: karkoe@rm.dk.'}, {'ForeName': 'Louisa G', 'Initials': 'LG', 'LastName': 'Sylvia', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Valerie L', 'Initials': 'VL', 'LastName': 'Ruberto', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Kuperberg', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Alec P', 'Initials': 'AP', 'LastName': 'Shannon', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Fung', 'Affiliation': 'Mongan Institute, Massachusetts General Hospital; Department of Medicine, Harvard Medical School.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Overhage', 'Affiliation': 'Mongan Institute, Massachusetts General Hospital.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Calabrese', 'Affiliation': 'Department of Psychiatry, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Thase', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Bowden', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center, San Antonio, TX, USA.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'Department of Psychiatry, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'McInnis', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Tohen', 'Affiliation': 'Department of Psychiatry, University of New Mexico Health Science Center, Albuquerque, NM, USA.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Kocsis', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Terence A', 'Initials': 'TA', 'LastName': 'Ketter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Friedman', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Dan V', 'Initials': 'DV', 'LastName': 'Iosifescu', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'McElroy', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, OH and Lindner Center of HOPE, Mason, OH, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Ostacher', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Nierenberg', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.03.157']
1747,32035854,Randomized Trial of a Virtual Reality Tool to Teach Surgical Technique for Tibial Shaft Fracture Intramedullary Nailing.,"INTRODUCTION


Active learning methods have accumulated popularity due to improved results in knowledge acquisition as opposed to passive learning methods. For surgical resident physicians with limited training opportunities outside of the operating room due to time constraints, virtual reality (VR) is a relatively inexpensive and time-efficient active training method for procurement of surgical skills. We conducted a simulated intramedullary nailing (IMN) of a tibia to demonstrate VR training programs as a more effective modality of learning orthopedic surgical techniques compared to passive learning tools such as a standard guide (SG) through trained novice medical students performing a SawBones simulation of intramedullary nail fixation.
MATERIALS AND METHODS


First and second-year medical students without prior experience of procedure were recruited and randomized to SG or VR training. Participants were observed performing simulated tibia IMN procedure immediately after training and evaluated by a blinded attending surgeon using procedure-specific checklist and 5-point global assessment scale. Participants returned after 2-weeks for repeat training and evaluation.
RESULTS


20 participants were recruited and randomized into VR (n = 10) and SG (n = 10) groups. All 20 participants completed the first phase and 17 completed the second phase of the study. Aggregate global assessment scores were significantly higher for VR than SG group (17.5 vs. 7.5, p < 0.001), including scores in all individual categories. The percentage of steps completed correctly was significantly higher in the VR group compared to the SG group (63% vs. 25%, p < 0.002). Average improvement between the first and second phases of the study were higher in the VR group compared to SG group across all 5-categories of the global assessment scale, and significantly higher for knowledge of instruments (50% vs. 11%, p, 0.01).
DISCUSSION


VR training was more effective than a passive SG in our model of simulated tibia IMN for novice medical students. Virtual reality training may be a useful method to augment orthopedic education.",2020,"Average improvement between the first and second phases of the study were higher in the VR group compared to SG group across all 5-categories of the global assessment scale, and significantly higher for knowledge of instruments (50% vs. 11%, p, 0.01).
","['20 participants', 'novice medical students', 'trained novice medical students performing a SawBones simulation of intramedullary nail fixation', 'All 20 participants completed the first phase and 17 completed the second phase of the study', 'First and second-year medical students without prior experience of procedure', 'Tibial Shaft Fracture Intramedullary Nailing']","['VR training', 'Virtual Reality Tool to Teach Surgical Technique', 'simulated intramedullary nailing (IMN) of a tibia to demonstrate VR training programs', 'Virtual reality training', 'SG or VR training', 'SG']","['Aggregate global assessment scores', 'percentage of steps completed correctly']","[{'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0336581', 'cui_str': 'Intramedullary rod, device (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0337141', 'cui_str': 'Shaft (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0021885', 'cui_str': 'Intramedullary Nailing'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0021885', 'cui_str': 'Intramedullary Nailing'}, {'cui': 'C0040184', 'cui_str': 'Tibia'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205418', 'cui_str': 'Aggregate (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",20.0,0.0186146,"Average improvement between the first and second phases of the study were higher in the VR group compared to SG group across all 5-categories of the global assessment scale, and significantly higher for knowledge of instruments (50% vs. 11%, p, 0.01).
","[{'ForeName': 'Gideon', 'Initials': 'G', 'LastName': 'Blumstein', 'Affiliation': 'Department of Orthopedic Surgery, David Geffen School of Medicine at UCLA, Los Angeles, California. Electronic address: gblumstein@mednet.ucla.edu.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Zukotynski', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Cevallos', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Ishmael', 'Affiliation': 'Department of Orthopedic Surgery, David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Zoller', 'Affiliation': 'Department of Orthopedic Surgery, David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Zach', 'Initials': 'Z', 'LastName': 'Burke', 'Affiliation': 'Department of Orthopedic Surgery, David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Clarkson', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Department of Orthopedic Surgery, David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Bernthal', 'Affiliation': 'Department of Orthopedic Surgery, David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Nelson F', 'Initials': 'NF', 'LastName': 'SooHoo', 'Affiliation': 'Department of Orthopedic Surgery, David Geffen School of Medicine at UCLA, Los Angeles, California.'}]",Journal of surgical education,['10.1016/j.jsurg.2020.01.002']
1748,32078486,Disability After Minor Stroke and Transient Ischemic Attack in the POINT Trial.,"Background and Purpose- While combination aspirin and clopidogrel reduces recurrent stroke compared with aspirin alone in patients with transient ischemic attack (TIA) or minor stroke, the effect on disability is uncertain. Methods- The POINT trial (Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke) randomized patients with TIA or minor stroke (National Institutes of Health Stroke Scale score ≤3) within 12 hours of onset to dual antiplatelet therapy (DAPT) with aspirin plus clopidogrel versus aspirin alone. The primary outcome measure was a composite of stroke, myocardial infarction, or vascular death. We performed a post hoc exploratory analysis to examine the effect of treatment on overall disability (defined as modified Rankin Scale score >1) at 90 days, as well as disability ascribed by the local investigator to index or recurrent stroke. We also evaluated predictors of disability. Results- At 90 days, 188 of 1964 (9.6%) of patients enrolled with TIA and 471 of 2586 (18.2%) of those enrolled with stroke were disabled. Overall disability was similar between patients assigned DAPT versus aspirin alone (14.7% versus 14.3%; odds ratio, 0.97 [95% CI, 0.82-1.14];  P =0.69). However, there were numerically fewer patients with disability in conjunction with a primary outcome event in the DAPT arm (3.0% versus 4.0%; odds ratio, 0.73 [95% CI, 0.53-1.01];  P =0.06) and significantly fewer patients in the DAPT arm with disability attributed by the investigators to either the index event or recurrent stroke (5.9% versus 7.4%; odds ratio, 0.78 [95% CI, 0.62-0.99];  P =0.04). Notably, disability attributed to the index event accounted for the majority of this difference (4.5% versus 6.0%; odds ratio, 0.74 [95% CI, 0.57-0.96];  P =0.02). In multivariate analysis, age, subsequent ischemic stroke, serious adverse events, and major bleeding were significantly associated with disability in TIA; for those with stroke, female sex, hypertension, or diabetes mellitus, National Institutes of Health Stroke Scale score, recurrent ischemic stroke, subsequent myocardial infarction, and serious adverse events were associated with disability. Conclusions- In addition to reducing recurrent stroke in patients with acute minor stroke and TIA, DAPT might reduce stroke-related disability. Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT00991029.",2020,"In multivariate analysis, age, subsequent ischemic stroke, serious adverse events, and major bleeding were significantly associated with disability in TIA; for those with stroke, female sex, hypertension, or diabetes mellitus, National Institutes of Health Stroke Scale score, recurrent ischemic stroke, subsequent myocardial infarction, and serious adverse events were associated with disability.","['patients with TIA or minor stroke (National Institutes of Health Stroke Scale score ≤3) within 12 hours of onset to dual antiplatelet therapy (DAPT) with', 'patients with transient ischemic attack (TIA) or minor stroke']","['DAPT', 'aspirin', 'aspirin and clopidogrel', 'Methods', ' and Purpose', 'aspirin plus clopidogrel versus aspirin alone', 'Conclusions']","['overall disability', 'index event or recurrent stroke', 'female sex, hypertension, or diabetes mellitus, National Institutes of Health Stroke Scale score, recurrent ischemic stroke, subsequent myocardial infarction, and serious adverse events', 'composite of stroke, myocardial infarction, or vascular death', 'Overall disability', 'recurrent stroke', 'ischemic stroke, serious adverse events, and major bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0348593', 'cui_str': 'Subsequent myocardial infarction (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",,0.144752,"In multivariate analysis, age, subsequent ischemic stroke, serious adverse events, and major bleeding were significantly associated with disability in TIA; for those with stroke, female sex, hypertension, or diabetes mellitus, National Institutes of Health Stroke Scale score, recurrent ischemic stroke, subsequent myocardial infarction, and serious adverse events were associated with disability.","[{'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Cucchiara', 'Affiliation': 'From the Department of Neurology, University of Pennsylvania, Philadelphia (B.C.).'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Elm', 'Affiliation': 'Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston (J.E.).'}, {'ForeName': 'J Donald', 'Initials': 'JD', 'LastName': 'Easton', 'Affiliation': 'Department of Neurology, University of California, San Francisco (J.D.E.).'}, {'ForeName': 'Shelagh B', 'Initials': 'SB', 'LastName': 'Coutts', 'Affiliation': 'Department of Clinical Neurosciences, Radiology and Community Health Sciences, University of Calgary, Hotchkiss Brain Institute, AB, Canada (S.B.C.).'}, {'ForeName': 'Joshua Z', 'Initials': 'JZ', 'LastName': 'Willey', 'Affiliation': 'Department of Neurology, Columbia University, New York, NY (J.Z.W.).'}, {'ForeName': 'Michelle H', 'Initials': 'MH', 'LastName': 'Biros', 'Affiliation': 'Emergency Medicine, University of Minnesota, Minneapolis (M.H.B.).'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Ross', 'Affiliation': 'Department of Neurology, Emory University, Atlanta, GA (M.A.R.).'}, {'ForeName': 'S Claiborne', 'Initials': 'SC', 'LastName': 'Johnston', 'Affiliation': ""Emergency Medicine Dean's Office, Dell Medical School, University of Texas-Austin (S.C.J.).""}]",Stroke,['10.1161/STROKEAHA.119.027465']
1749,22971593,The cost-effectiveness of rapid HIV testing in substance abuse treatment: results of a randomized trial.,"BACKGROUND


The President's National HIV/AIDS Strategy calls for coupling HIV screening and prevention services with substance abuse treatment programs. Fewer than half of US community-based substance abuse treatment programs make HIV testing available on-site or through referral.
METHODS


We measured the cost-effectiveness of three HIV testing strategies evaluated in a randomized trial conducted in 12 community-based substance abuse treatment programs in 2009: off-site testing referral, on-site rapid testing with information only, on-site rapid testing with risk-reduction counseling. Data from the trial included patient demographics, prior testing history, test acceptance and receipt of results, undiagnosed HIV prevalence (0.4%) and program costs. The Cost-Effectiveness of Preventing AIDS Complications (CEPAC) computer simulation model was used to project life expectancy, lifetime costs, and quality-adjusted life years (QALYs) for HIV-infected individuals. Incremental cost-effectiveness ratios (2009 US $/QALY) were calculated after adding costs of testing HIV-uninfected individuals; costs and QALYs were discounted at 3% annually.
RESULTS


Referral for off-site testing is less efficient (dominated) compared to offering on-site testing with information only. The cost-effectiveness ratio for on-site testing with information is $60,300/QALY in the base case, or $76,300/QALY with 0.1% undiagnosed HIV prevalence. HIV risk-reduction counseling costs $36 per person more without additional benefit.
CONCLUSIONS


A strategy of on-site rapid HIV testing offer with information only in substance abuse treatment programs increases life expectancy at a cost-effectiveness ratio <$100,000/QALY. Policymakers and substance abuse treatment leaders should seek funding to implement on-site rapid HIV testing in substance abuse treatment programs for those not recently tested.",2013,Policymakers and substance abuse treatment leaders should seek funding to implement on-site rapid HIV testing in substance abuse treatment programs for those not recently tested.,"['12 community-based substance abuse treatment programs in 2009: off-site testing referral, on-site rapid testing with information only, on-site rapid testing with risk-reduction counseling', 'substance abuse treatment']",['rapid HIV testing'],"['Cost-Effectiveness', 'life expectancy', 'project life expectancy, lifetime costs, and quality-adjusted life years (QALYs', 'cost-effectiveness ratio', 'Incremental cost-effectiveness ratios', 'HIV risk-reduction counseling costs', 'cost-effectiveness']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0740858', 'cui_str': 'Substance Abuse'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]",,0.0446511,Policymakers and substance abuse treatment leaders should seek funding to implement on-site rapid HIV testing in substance abuse treatment programs for those not recently tested.,"[{'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Schackman', 'Affiliation': 'Department of Public Health, Weill Cornell Medical College, 402 East 67th Street, New York, NY 10065, USA. brs2006@med.cornell.edu'}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Metsch', 'Affiliation': ''}, {'ForeName': 'Grant N', 'Initials': 'GN', 'LastName': 'Colfax', 'Affiliation': ''}, {'ForeName': 'Jared A', 'Initials': 'JA', 'LastName': 'Leff', 'Affiliation': ''}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': ''}, {'ForeName': 'Callie A', 'Initials': 'CA', 'LastName': 'Scott', 'Affiliation': ''}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Feaster', 'Affiliation': ''}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Gooden', 'Affiliation': ''}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Matheson', 'Affiliation': ''}, {'ForeName': 'Louise F', 'Initials': 'LF', 'LastName': 'Haynes', 'Affiliation': ''}, {'ForeName': 'A David', 'Initials': 'AD', 'LastName': 'Paltiel', 'Affiliation': ''}, {'ForeName': 'Rochelle P', 'Initials': 'RP', 'LastName': 'Walensky', 'Affiliation': ''}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2012.08.009']
1750,31387081,"The Acute Effects of a ""Reduced Sitting Preschool Day"" on Executive Function and Musculoskeletal Health in Preschoolers: A Randomized Cross-Over Study.","PURPOSE


To examine the acute effects of a reduced sitting day on executive function (EF) and musculoskeletal health in preschoolers.
METHODS


A sample of 29 children (54% boys; 4-5 y) participated in a randomized cross-over trial. Each child completed 2 protocols, which simulate a day at childcare in random order for 2.5 hours; a typical preschool day (50% sitting) and a reduced preschool day (25% sitting) where most sitting activities were replaced with standing activities. Sitting, standing, and stepping time were objectively assessed using an activPAL accelerometer. EF was evaluated using tablet-based EF assessments (inhibition, working memory, and task shifting). Musculoskeletal health was assessed using a handheld dynamometer and goniometer.
RESULTS


Compared with the typical preschool day, the reduced sitting day showed no significant differences for EF scores. Effect sizes for inhibition (d = 0.04), working memory (d = 0.02), and shifting (d = 0.11) were all small. For musculoskeletal health, no significant differences were reported after the reduced preschool day. The effect sizes for the hip extension force, hamstring flexibility, gastrocnemius length, and balancing on 1 leg were all small (d = 0.21, d = 0.25, d = 0.28, and d = 0.28).
CONCLUSIONS


This study suggests that reducing sitting time is unlikely to result in acute changes in EF and musculoskeletal health among preschoolers.",2019,"The effect sizes for the hip extension force, hamstring flexibility, gastrocnemius length, and balancing on 1 leg were all small (d = 0.21, d = 0.25, d = 0.28, and d = 0.28).
","['29 children (54% boys; 4-5\xa0y', 'preschoolers', 'Preschoolers']",['Reduced Sitting Preschool Day'],"['Musculoskeletal health', 'EF scores', 'working memory', 'Executive Function and Musculoskeletal Health', 'hip extension force, hamstring flexibility, gastrocnemius length, and balancing on 1 leg', 'Sitting, standing, and stepping time', 'executive function (EF) and musculoskeletal health']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0870221', 'cui_str': 'Boys'}]","[{'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",29.0,0.149474,"The effect sizes for the hip extension force, hamstring flexibility, gastrocnemius length, and balancing on 1 leg were all small (d = 0.21, d = 0.25, d = 0.28, and d = 0.28).
","[{'ForeName': 'Yvonne G', 'Initials': 'YG', 'LastName': 'Ellis', 'Affiliation': 'University of Wollongong.'}, {'ForeName': 'Dylan P', 'Initials': 'DP', 'LastName': 'Cliff', 'Affiliation': 'University of Wollongong.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Howard', 'Affiliation': 'University of Wollongong.'}, {'ForeName': 'Anthony D', 'Initials': 'AD', 'LastName': 'Okely', 'Affiliation': 'University of Wollongong.'}]",Pediatric exercise science,['10.1123/pes.2018-0239']
1751,22889694,Predictors of treatment response in adolescents with comorbid substance use disorder and attention-deficit/hyperactivity disorder.,"Attention-Deficit/Hyperactivity Disorder (ADHD) frequently co-occurs with substance use disorder (SUD) and is associated with poor substance-use treatment outcomes. A trial evaluating osmotic-release oral system methylphenidate (OROS-MPH) for adolescents with ADHD and SUD, concurrently receiving behavioral therapy, revealed inconsistent medication effects on ADHD or SUD. Clinical care for this population would be advanced by knowledge of treatment outcome predictors. Data from the randomized placebo-controlled trial (n = 299) were analyzed. Significant treatment predictors included: 1) Substance use severity, associated with poorer ADHD and SUD outcomes, 2) ADHD severity, associated with better ADHD and SUD outcomes, 3) comorbid conduct disorder, associated with poorer ADHD outcomes, and 4) court-mandated status, associated with better SUD outcomes but poorer treatment completion. An interaction effect showed that OROS-MPH improved SUD outcomes in adolescents with comorbid conduct disorder compared to placebo. While severe SUD may require more intensive psychosocial treatment, OROS-MPH may improve substance treatment outcomes in adolescents with co-morbid attention and conduct problems.",2013,"A trial evaluating osmotic-release oral system methylphenidate (OROS-MPH) for adolescents with ADHD and SUD, concurrently receiving behavioral therapy, revealed inconsistent medication effects on ADHD or SUD.","['adolescents with ADHD and SUD', 'adolescents with co-morbid attention and conduct problems', 'adolescents with comorbid conduct disorder', 'adolescents with comorbid substance use disorder and attention-deficit/hyperactivity disorder']","['OROS-MPH', 'placebo', 'osmotic-release oral system methylphenidate (OROS-MPH']","['SUD outcomes', ' 1) Substance use severity, associated with poorer ADHD and SUD outcomes, 2) ADHD severity, associated with better ADHD and SUD outcomes, 3) comorbid conduct disorder, associated with poorer ADHD outcomes, and 4) court-mandated status, associated with better SUD outcomes']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0149654', 'cui_str': 'Conduct Disorder'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}]","[{'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}]","[{'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0149654', 'cui_str': 'Conduct Disorder'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",299.0,0.101792,"A trial evaluating osmotic-release oral system methylphenidate (OROS-MPH) for adolescents with ADHD and SUD, concurrently receiving behavioral therapy, revealed inconsistent medication effects on ADHD or SUD.","[{'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Tamm', 'Affiliation': ""Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229, USA. leanne.tamm@cchmc.org""}, {'ForeName': 'Kathlene', 'Initials': 'K', 'LastName': 'Trello-Rishel', 'Affiliation': ''}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Riggs', 'Affiliation': ''}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Nakonezny', 'Affiliation': ''}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Acosta', 'Affiliation': ''}, {'ForeName': 'Genie', 'Initials': 'G', 'LastName': 'Bailey', 'Affiliation': ''}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': ''}]",Journal of substance abuse treatment,['10.1016/j.jsat.2012.07.001']
1752,22837893,Prevention of hypotension and prolongation of postoperative analgesia in emergency cesarean sections: A randomized study with intrathecal clonidine.,"BACKGROUND AND CONTEXT


Different adjuvants been tried out for neuraxial anesthesia in emergency caesarean section so that the dose of the local anesthetic can be reduced and hypotension thereby prevented.
AIMS AND OBJECTIVES


The present study was carried out in patients presenting for emergency lower segment caesarean section (LSCS) to establish the dose of intrathecal clonidine that would allow reduction of the dose of local anesthetic (thereby reducing the incidence and magnitude of hypotension) while at the same time providing clinically relevant prolongation of spinal anesthesia without significant side effects.
MATERIALS AND METHODS


This randomized clinical study was carried out in our institution among 100 pregnant females who underwent emergency caesarean section. The participants were divided randomly into four groups: A, B, C, and D, each comprising 25 parturients. Subarachnoid block was performed using a 26G Quincke needle, with 12 mg of hyperbaric bupivacaine (LA) in group A, 9 mg of LA + 30 μg of clonidine in group B, LA + 37.5 μg of clonidine in group C, and LA + 45 μg of clonidine in group D. The solution was uniformly made up to 2.2 mL with normal saline in all the groups. Onset of analgesia at T(10) level, sensory and motor blockade levels, maternal heart rate and blood pressure, neonatal Apgar scores, postoperative block characteristics, and adverse events were looked for and recorded. Statistical analysis was carried out with SPSS(®) version 10.0 for Windows(®), using the ANOVA test with post hoc significance, the Chi-square test, and the Mann-Whitney U test. P<.05 was considered significant and P<.0001 as highly significant.
RESULTS


One hundred patients were enrolled for this study. The four groups were comparable with regard to demographic data and neonatal Apgar scores. Onset and establishment of sensory and motor analgesia was significantly shorter in groups C and D, while hypotension (and the use of vasopressors) was significantly higher in groups A and D. Perioperative shivering, nausea, and vomiting were significantly higher in groups A and D, while incidence of dry mouth was significantly higher in group D.
CONCLUSIONS


The addition of 45 μg, 37.5 μg, and 30 μg of clonidine to hyperbaric bupivacaine results in more prolonged complete and effective analgesia, allowing reduction of up to 18% of the total dose of hyperbaric bupivacaine. From the results of this study, 37.5 μg of clonidine seems to be the optimal dose.",2012,The four groups were comparable with regard to demographic data and neonatal Apgar scores.,"['100 pregnant females who underwent emergency caesarean section', 'One hundred patients were enrolled for this study', 'emergency cesarean sections', 'patients presenting for emergency lower segment caesarean section (LSCS) to establish the dose of']","['intrathecal clonidine', 'hyperbaric bupivacaine', 'clonidine to hyperbaric bupivacaine', 'LA + 37.5 μg of clonidine', 'clonidine', 'hyperbaric bupivacaine (LA', 'LA + 45 μg of clonidine', 'LA + 30 μg of clonidine']","['incidence of dry mouth', 'demographic data and neonatal Apgar scores', 'prolonged complete and effective analgesia', 'Perioperative shivering, nausea, and vomiting', 'Onset and establishment of sensory and motor analgesia', 'Onset of analgesia at T(10) level, sensory and motor blockade levels, maternal heart rate and blood pressure, neonatal Apgar scores, postoperative block characteristics, and adverse events']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0558380', 'cui_str': 'Emergency cesarean section'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0473299', 'cui_str': 'Emergency lower segment cesarean section (procedure)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C4517742', 'cui_str': '37.5 (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0036973', 'cui_str': 'Shiverings'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",100.0,0.0625637,The four groups were comparable with regard to demographic data and neonatal Apgar scores.,"[{'ForeName': 'Sukhminder Jit Singh', 'Initials': 'SJ', 'LastName': 'Bajwa', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Gian Sagar Medical College and Hospital, Banur, Punjab, India.'}, {'ForeName': 'Sukhwinder Kaur', 'Initials': 'SK', 'LastName': 'Bajwa', 'Affiliation': ''}, {'ForeName': 'Jasbir', 'Initials': 'J', 'LastName': 'Kaur', 'Affiliation': ''}, {'ForeName': 'Amarjit', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': ''}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': ''}, {'ForeName': 'Surjit Singh', 'Initials': 'SS', 'LastName': 'Parmar', 'Affiliation': ''}]",International journal of critical illness and injury science,['10.4103/2229-5151.97269']
1753,32422870,Urinary Metabolomic Profiling Analysis and Evaluation of the Effect of  Ecklonia cava  Extract Intake.,"Metabolomics is a powerful tool for the investigation of interactions between diet, nutrients, and human metabolism.  Ecklonia cava  is an edible brown alga that is abundantly found in Korea and Japan and contains unique polyphenols referred to as phlorotannins. However, there are few metabolomics studies related to the effects of polyphenols in humans. In this study, we performed a mass spectrometry-based metabolomics analysis of urine samples from participants with a body mass index (BMI) higher than 25 kg/m 2  and lower than 30 kg/m 2  to investigate the effects of the intake of seapolynol isolated from  E. cava . Metabolomic profiling showed that the levels of riboflavin, urocanic acid, 5-hydroxy-6-methoxyindole glucuronide, and guanidino valeric acid were significantly increased in the seapolynol intake group compared with the placebo group. A correlation analysis was performed to identify the association between the metabolites' levels and clinical characteristics related to body fat. Among the metabolites whose concentrations changed in the seapolynol intake group, riboflavin was associated with BMI, body weight, fat mass, and percent body fat. These findings suggest that the decreased body fat induced by the intake of seapolynol is related to an increase in the antioxidant effect of riboflavin.",2020,"Metabolomic profiling showed that the levels of riboflavin, urocanic acid, 5-hydroxy-6-methoxyindole glucuronide, and guanidino valeric acid were significantly increased in the seapolynol intake group compared with the placebo group.",['participants with a body mass index (BMI) higher than 25 kg/m 2  and lower than 30 kg/m 2  to investigate the effects of the intake of seapolynol isolated from  E. cava '],"['Ecklonia cava  Extract Intake', 'riboflavin', 'placebo']","['levels of riboflavin, urocanic acid, 5-hydroxy-6-methoxyindole glucuronide, and guanidino valeric acid']","[{'cui': 'C0231254', 'cui_str': 'Increased body mass index'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0521083', 'cui_str': 'Piper methysticum'}]","[{'cui': 'C3539019', 'cui_str': 'Ecklonia cava extract'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0035527', 'cui_str': 'Riboflavin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035527', 'cui_str': 'Riboflavin'}, {'cui': 'C0042054', 'cui_str': 'Urocanic acid'}, {'cui': 'C0613386', 'cui_str': '5-hydroxy-6-methoxyindole glucuronide'}, {'cui': 'C0068263', 'cui_str': 'valeric acid'}]",,0.0419617,"Metabolomic profiling showed that the levels of riboflavin, urocanic acid, 5-hydroxy-6-methoxyindole glucuronide, and guanidino valeric acid were significantly increased in the seapolynol intake group compared with the placebo group.","[{'ForeName': 'Juyeon', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Integrated Metabolomics Research Group, Western Seoul Center, Korea Basic Science Institute, Seoul 120-140, Korea.'}, {'ForeName': 'Youngae', 'Initials': 'Y', 'LastName': 'Jung', 'Affiliation': 'Integrated Metabolomics Research Group, Western Seoul Center, Korea Basic Science Institute, Seoul 120-140, Korea.'}, {'ForeName': 'Eunok', 'Initials': 'E', 'LastName': 'Lee', 'Affiliation': 'Department of Nutritional Science and Food Management, Ewha Womans University, Seoul 03760, Korea.'}, {'ForeName': 'Seoyeong', 'Initials': 'S', 'LastName': 'Jang', 'Affiliation': 'Integrated Metabolomics Research Group, Western Seoul Center, Korea Basic Science Institute, Seoul 120-140, Korea.'}, {'ForeName': 'Do Hyun', 'Initials': 'DH', 'LastName': 'Ryu', 'Affiliation': 'Department of Chemistry, Sungkyunkwan University, Suwon 440-746, Korea.'}, {'ForeName': 'Oran', 'Initials': 'O', 'LastName': 'Kwon', 'Affiliation': 'Department of Nutritional Science and Food Management, Ewha Womans University, Seoul 03760, Korea.'}, {'ForeName': 'Geum-Sook', 'Initials': 'GS', 'LastName': 'Hwang', 'Affiliation': 'Integrated Metabolomics Research Group, Western Seoul Center, Korea Basic Science Institute, Seoul 120-140, Korea.'}]",Nutrients,['10.3390/nu12051407']
1754,32423151,Effects of Different Ankle Supports on the Single-Leg Lateral Drop Landing Following Muscle Fatigue in Athletes with Functional Ankle Instability.,"BACKGROUND


Ankle support has been utilized for athletes with functional ankle instability (FAI), however, its effect on the landing performance during muscle fatigue is not well understood. This study aimed to examine the effects of ankle supports (ankle brace vs. Kinesio tape) on athletes with FAI following fatigued single-leg landing.
METHODS


Thirty-three young FAI athletes (CAIT scores < 24) were randomly allocated to control (Cn), ankle brace (AB) and Kinesio tape (KT) groups. All athletes performed single-leg lateral drop landings following ankle fatigue protocol. The fatigue-induced changes in kinetic parameters were measured among three groups.
RESULTS


A significant increase in peak vertical ground reaction force (vGRF) was found in the AB group (0.12% body weight (BW)) compared to that of the KT (0.02% BW) and Cn (median = 0.01% BW) groups. Significant decrease in both COP medial-lateral (ML) and anterior-posterior (AP) ranges were also found in the KT group (median = -0.15% foot width (FW) & median = -0.28% foot length (FL)) than those of the Cn group (median = 0.67% FW& median = 0.88% FL).
CONCLUSIONS


Ankle braces might hamper the ability to absorb the impact force during landing. On the other hand, Kinesio tape might be beneficial for the postural control during landing.",2020,A significant increase in peak vertical ground reaction force (vGRF) was found in the AB group (0.12% body weight (BW)) compared to that of the KT (0.02% BW) and Cn (median = 0.01% BW) groups.,"['Athletes with Functional Ankle Instability', 'athletes with FAI following fatigued single-leg landing', 'Thirty-three young FAI athletes (CAIT scores < 24', 'athletes with functional ankle instability (FAI']","['Single-Leg Lateral Drop Landing', 'ankle supports (ankle brace vs. Kinesio tape', 'control (Cn), ankle brace (AB) and Kinesio tape (KT']","['peak vertical ground reaction force (vGRF', 'COP medial-lateral (ML) and anterior-posterior (AP) ranges']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0277851', 'cui_str': 'Ankle instability'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0056471', 'cui_str': 'creatinolfosfate'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",33.0,0.0268298,A significant increase in peak vertical ground reaction force (vGRF) was found in the AB group (0.12% body weight (BW)) compared to that of the KT (0.02% BW) and Cn (median = 0.01% BW) groups.,"[{'ForeName': 'Cheng-Chieh', 'Initials': 'CC', 'LastName': 'Lin', 'Affiliation': 'Department of Physical Therapy, Tzu Hui Institute of Technology, Pingtung 926001, Taiwan.'}, {'ForeName': 'Shing-Jye', 'Initials': 'SJ', 'LastName': 'Chen', 'Affiliation': 'Department of Product Design, College of Design, Tainan University of Technology, Tainan 71002, Taiwan.'}, {'ForeName': 'Wan-Chin', 'Initials': 'WC', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, College of Medicine, National Cheng Kung University, Tainan 70101, Taiwan.'}, {'ForeName': 'Cheng-Feng', 'Initials': 'CF', 'LastName': 'Lin', 'Affiliation': 'Department of Physical Therapy, College of Medicine, National Cheng Kung University, Tainan 70101, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph17103438']
1755,31915172,Protocol for studying racial/ethnic disparities in depression care using joint information from participant surveys and administrative claims databases: an observational cohort study.,"INTRODUCTION


Current evidence indicates that older racial/ethnic minorities encounter disparities in depression care. Because late-life depression is common and confers major adverse health consequences, it is imperative to reduce disparities in depression care. Thus, the primary objectives of this protocol are to: (1) quantify racial/ethnic disparities in depression treatment and (2) identify and quantify the magnitude of these disparities accountable for by a multifactorial combination of patient, provider and healthcare system factors.
METHODS AND ANALYSIS


Data will be derived from the Vitamin D and Omega-3 Trial-Depression Endpoint Prevention (VITAL-DEP) study, a late-life depression prevention ancillary study to the VITAL trial. A total of 25 871 men and women, aged 50+ and 55+ years, respectively, were randomised in a 2×2 factorial randomised trial of heart disease and cancer prevention to receive vitamin D and/or fish oil for 5 years starting from 2011. Most participants were aged 65+ years old at randomisation. Medicare claims data for over 19 000 VITAL/VITAL-DEP participants were linked to conduct our study.The major study outcomes are depression treatment ( antidepressant use and/or receipt of psychotherapy services ) and adherence to medication treatment ( antidepressant adherence and acceptability ). The National Academy of Medicine framework for studying racial disparities was leveraged to select patient-level, provider-level and healthcare system-level variables and to address their potential roles in depression care disparities. Blinder-Oaxaca regression decomposition methods will be implemented to quantify and identify correlates of racial/ethnic disparities in depression treatment and adherence.
ETHICS AND DISSEMINATION


This study received Institutional Review Board (IRB) approval from the Partners Healthcare (PHS) IRB, protocol# 2010P001881. We plan to disseminate our results through publication of manuscripts patient engagement activities, such as study newsletters regularly sent out to VITAL participants, and presentations at scientific meetings.
TRIAL REGISTRATION NUMBER


NCT01696435.",2020,"A total of 25 871 men and women, aged 50+ and 55+ years, respectively, were randomised in a 2×2 factorial randomised trial of heart disease and cancer prevention to receive vitamin D and/or fish oil for 5 years starting from 2011.","['Most participants were aged 65+ years old at randomisation', 'A total of 25 871 men and women, aged 50+ and 55+ years']",['heart disease and cancer prevention to receive vitamin D and/or fish oil'],['depression treatment ( antidepressant use'],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",,0.148351,"A total of 25 871 men and women, aged 50+ and 55+ years, respectively, were randomised in a 2×2 factorial randomised trial of heart disease and cancer prevention to receive vitamin D and/or fish oil for 5 years starting from 2011.","[{'ForeName': 'Macarius', 'Initials': 'M', 'LastName': 'Donneyong', 'Affiliation': 'Pharmacy Practice and Science, College of Pharmacy, The Ohio University State University, Columbus, Ohio, USA donneyong.1@osu.edu.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Reynolds', 'Affiliation': 'Psychiatry, Harvard University T H Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mischoulon', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Chang', 'Affiliation': 'Psychiatry, Harvard University, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Luttmann-Gibson', 'Affiliation': ""Psychiatry, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Bubes', 'Affiliation': ""Psychiatry, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'McKenna', 'Initials': 'M', 'LastName': 'Guilds', 'Affiliation': 'Pharmacy, Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Joann', 'Initials': 'J', 'LastName': 'Manson', 'Affiliation': ""Psychiatry, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Okereke', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}]",BMJ open,['10.1136/bmjopen-2019-033173']
1756,32423143,Effect of Impulsivity Traits on Food Choice within a Nudging Intervention.,"Food choices are often driven by impulsive tendencies rather than rational consideration. Some individuals may find it more difficult resisting impulses related to unhealthy food choices, and low self-control and high impulsivity have been suggested to be linked to these behaviors. Recent shifts have been made towards developing strategies that target automatic processes of decision-making and focus on adjusting the environment, referred to as nudging interventions. Therefore, the purpose of this study was to investigate the effect of impulsivity traits on food choices within a nudging intervention (increased perceived variety). A total of 83 adults participated in an experimental study consisting of a self-service intelligent buffet. Impulsivity traits were measured using the UPPS-P impulsivity scale. General linear models were fitted to evaluate the effect of the five impulsivity traits on the difference of salad consumption (g) between the control and intervention situations. Results showed that impulsivity does not affect food choices in this nudging situation, suggesting that nudging works independently of the participant's impulsivity score. Results also showed a significantly higher consumption of salad in the nudging versus the control setting (17.6 g, p < 0.05), suggesting that nudging interventions can be effective in significantly increasing total vegetable consumption across the whole impulsivity scale.",2020,"Results also showed a significantly higher consumption of salad in the nudging versus the control setting (17.6 g, p < 0.05), suggesting that nudging interventions can be effective in significantly increasing total vegetable consumption across the whole impulsivity scale.",['83 adults participated in an experimental study consisting of a self-service intelligent buffet'],[],"['Impulsivity traits', 'higher consumption of salad', 'UPPS-P impulsivity scale', 'total vegetable consumption']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",[],"[{'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0453740', 'cui_str': 'Salad'}, {'cui': 'C0200005', 'cui_str': 'Urethral pressure profile study'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}]",83.0,0.0272269,"Results also showed a significantly higher consumption of salad in the nudging versus the control setting (17.6 g, p < 0.05), suggesting that nudging interventions can be effective in significantly increasing total vegetable consumption across the whole impulsivity scale.","[{'ForeName': 'Irene C F', 'Initials': 'ICF', 'LastName': 'Marques', 'Affiliation': 'Future Consumer Lab, Department of Food Science, Faculty of Science, University of Copenhagen, Rolighedsvej 26, 1958 Frederiksberg C, Denmark.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Ting', 'Affiliation': 'Future Consumer Lab, Department of Food Science, Faculty of Science, University of Copenhagen, Rolighedsvej 26, 1958 Frederiksberg C, Denmark.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Cedillo-Martínez', 'Affiliation': 'Future Consumer Lab, Department of Food Science, Faculty of Science, University of Copenhagen, Rolighedsvej 26, 1958 Frederiksberg C, Denmark.'}, {'ForeName': 'Federico J A', 'Initials': 'FJA', 'LastName': 'Pérez-Cueto', 'Affiliation': 'Future Consumer Lab, Department of Food Science, Faculty of Science, University of Copenhagen, Rolighedsvej 26, 1958 Frederiksberg C, Denmark.'}]",Nutrients,['10.3390/nu12051402']
1757,22771145,Frontal systems deficits in stimulant-dependent patients: evidence of pre-illness dysfunction and relationship to treatment response.,"BACKGROUND


Frontal systems dysfunction is present in stimulant-dependent patients. However, it is unclear whether this dysfunction is a pre-morbid risk factor or stimulant-induced, is severe enough to be clinically relevant, and if it is relevant to treatment response. These questions were addressed using the Frontal Systems Behavior Scale (FrSBe), a reliable and valid self-report assessment of three neurobehavioral domains associated with frontal systems functioning (Apathy, Disinhibition, and Executive Dysfunction, summed for a Total), that assesses both pre- and post-morbid functioning, and has a specific cutoff for defining clinically significant abnormalities.
METHOD


Six sites evaluating 12-step facilitation for stimulant abusers obtained the FrSBe from 180 methamphetamine- and/or cocaine-dependent participants. Dichotomous treatment response measures included self-reported stimulant use, stimulant urine drug screens, and treatment completion.
RESULTS


A substantial percentage of participants retrospectively reported clinically significant neurobehavioral abnormalities prior to lifetime stimulant abuse initiation (e.g., 67.5% on FrSBe-Total) with a significant increase in the proportion reporting such abnormalities for current functioning (86% on FrSBe-Total; p<0.0001). Treatment response was significantly worse for participants with, relative to those without, clinically significant Disinhibition as measured by treatment non-completion (31.6% vs. 15.6%, OR=2.51) and self-reported stimulant use during treatment (40.5% vs. 16.7%, OR=3.40).
CONCLUSION


These findings suggest that frontal systems dysfunction is present prior to stimulant-abuse onset and worsens with stimulant use. Disinhibition may be a prime target for intervention in stimulant-dependent individuals.",2013,"Treatment response was significantly worse for participants with, relative to those without, clinically significant Disinhibition as measured by treatment non-completion (31.6% vs. 15.6%, OR=2.51) and self-reported stimulant use during treatment (40.5% vs. 16.7%, OR=3.40).
",['Six sites evaluating 12-step facilitation for stimulant abusers obtained the FrSBe from 180 methamphetamine- and/or cocaine-dependent participants'],[],"['Frontal Systems Behavior Scale (FrSBe', 'self-reported stimulant use, stimulant urine drug screens, and treatment completion']","[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0234112', 'cui_str': 'Facilitation, function (observable entity)'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}]",[],"[{'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0222045'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.04162,"Treatment response was significantly worse for participants with, relative to those without, clinically significant Disinhibition as measured by treatment non-completion (31.6% vs. 15.6%, OR=2.51) and self-reported stimulant use during treatment (40.5% vs. 16.7%, OR=3.40).
","[{'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Winhusen', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3210 Jefferson Avenue, Cincinnati, OH 45220, USA. winhusen@carc.uc.edu'}, {'ForeName': 'Eugene C', 'Initials': 'EC', 'LastName': 'Somoza', 'Affiliation': ''}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'Frankie B', 'Initials': 'FB', 'LastName': 'Kropp', 'Affiliation': ''}, {'ForeName': 'Viviana Elizabeth', 'Initials': 'VE', 'LastName': 'Horigian', 'Affiliation': ''}, {'ForeName': 'Bryon', 'Initials': 'B', 'LastName': 'Adinoff', 'Affiliation': ''}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2012.06.017']
1758,32423006,A Serious Game Approach to Improve Food Behavior in Families-A Pilot Study.,"The objective of this pilot study was to investigate the effect of a specially developed serious game to improve food behavior in families with children aged 5-13 years using mixed methods. Fourteen families were randomized into a game-group and a non-game-group and divided into age groups (game-children (GC), game-parents (GP), non-game-children (nGC), and non-game-parents (nGP)). The families completed a baseline test, a three-week intervention period with or without a game element, and a follow-up test. Qualitative results showed a positive change in food behavior in all families. Quantitative results mainly showed an effect in food neophobia as a decrease was seen in all groups; however, it was only significant ( p  < 0.05) in three groups (GP, nGC, nGP). No changes were seen in willingness to taste, and only limited changes in liking and number of words used to describe the stimuli. In conclusion, qualitative results showed positive change in the children's food behavior in most families, indicating a positive effect of performing tastings and tasks together as a family-regardless of the presence of a game element. However, this was not as clear in the quantitative data, indicating that current quantitative tools are less suited to measure complex concepts like willingness to taste.",2020,"No changes were seen in willingness to taste, and only limited changes in liking and number of words used to describe the stimuli.","['Fourteen families', 'families with children aged 5-13 years using mixed methods']","['game-group and a non-game-group and divided into age groups (game-children (GC), game-parents (GP), non-game-children (nGC), and non-game-parents (nGP']","['food behavior', 'food neophobia']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3840121', 'cui_str': 'Avoidant restrictive food intake disorder'}]",14.0,0.0359656,"No changes were seen in willingness to taste, and only limited changes in liking and number of words used to describe the stimuli.","[{'ForeName': 'Sigrid', 'Initials': 'S', 'LastName': 'Skouw', 'Affiliation': 'Food Design and Consumer Behavior Section, Department of Food Science, University of Copenhagen, Rolighedsvej 26, 1958 Frederiksberg C, Denmark.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Suldrup', 'Affiliation': 'Food Design and Consumer Behavior Section, Department of Food Science, University of Copenhagen, Rolighedsvej 26, 1958 Frederiksberg C, Denmark.'}, {'ForeName': 'Annemarie', 'Initials': 'A', 'LastName': 'Olsen', 'Affiliation': 'Food Design and Consumer Behavior Section, Department of Food Science, University of Copenhagen, Rolighedsvej 26, 1958 Frederiksberg C, Denmark.'}]",Nutrients,['10.3390/nu12051415']
1759,32493088,"A Randomized, Placebo-Controlled Trial Evaluating Changes in Peripheral Neuropathy and Quality of Life by Using Low-Frequency Electrostimulation on Breast Cancer Patients Treated With Chemotherapy.","Background:  This study examined the effect of a portable low-frequency electrostimulation (ES) device on patients diagnosed with  chemotherapy-induced peripheral neuropathy  (CIPN) immediately after chemotherapy for breast cancer.  Methods:  A single-center, randomized, placebo-controlled trial was conducted. A total of 72 patients newly diagnosed with CIPN were enrolled and randomly placed into the ES (n = 36) or the sham ES group (SES; n = 36). Duloxetine or pregabalin was prescribed to all participants from the initial assessment. The devices for 14 days, at least twice a day, for at least 120 minutes. The primary outcomes were the overall intensities of the CIPN symptoms as assessed using Numerical Rating Scale (NRS). Secondary outcomes included Total Neuropathy Score (TNS), European Organization for Research and Treatment of Cancer Quality of Life (EORTC-QLQ), Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20), Functional Assessment of Cancer Therapy-Breast (FACT-B), and Instrument on Pattern Identification and Evaluation for CIPN (IPIE-CIPN).  Results:  No differences in NRS scores were found between the patients in the ES and the SES group ( P  = 0.267). Patients in both groups showed significantly reduced CIPN intensities (ES  P  < .001; SES  P  < .001). No significant differences between the groups were found in TNS, EORTC-QLQ, CIPN20, and FACT-B. The general symptoms of CIPN diagnosed as cold arthralgia showed significance only in the ES group ( P  = .006).  Conclusion:  Compared with a placebo, the effectiveness of the low-frequency ES device with pharmacological intervention was not significantly different, but a therapeutic effect was possible.",2020,"No significant differences between the groups were found in TNS, EORTC-QLQ, CIPN20, and FACT-B.","['72 patients newly diagnosed with CIPN', 'patients diagnosed with  chemotherapy-induced peripheral neuropathy  (CIPN) immediately after chemotherapy for breast cancer', 'Breast Cancer Patients Treated With Chemotherapy']","['Placebo', 'Duloxetine or pregabalin', 'portable low-frequency electrostimulation (ES) device', 'sham ES', 'Low-Frequency Electrostimulation', 'placebo']","['CIPN intensities', 'TNS, EORTC-QLQ, CIPN20, and FACT-B', 'overall intensities of the CIPN symptoms as assessed using Numerical Rating Scale (NRS', 'Total Neuropathy Score (TNS), European Organization for Research and Treatment of Cancer Quality of Life (EORTC-QLQ), Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20), Functional Assessment of Cancer Therapy-Breast', 'NRS scores', 'Peripheral Neuropathy and Quality of Life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0045733', 'cui_str': '2-(4-toluidino)-6-naphthalenesulfonic acid'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4727882', 'cui_str': 'Total neuropathy score'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}]",72.0,0.150093,"No significant differences between the groups were found in TNS, EORTC-QLQ, CIPN20, and FACT-B.","[{'ForeName': 'Si-Yeon', 'Initials': 'SY', 'LastName': 'Song', 'Affiliation': 'Dunsan Korean Medicine Hospital of Daejeon University, Daejeon, Republic of Korea.'}, {'ForeName': 'Ji-Hye', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Seoul Korean Medicine Hospital of Daejeon University, Seoul, Republic of Korea.'}, {'ForeName': 'Jin Sun', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Chungnam National University, Daejeon, Republic of Korea.'}, {'ForeName': 'Je Ryong', 'Initials': 'JR', 'LastName': 'Kim', 'Affiliation': 'Chungnam National University, Daejeon, Republic of Korea.'}, {'ForeName': 'Eun Hee', 'Initials': 'EH', 'LastName': 'Sohn', 'Affiliation': 'Chungnam National University Hospital, Daejeon, Republic of Korea.'}, {'ForeName': 'Mi Sook', 'Initials': 'MS', 'LastName': 'Jung', 'Affiliation': 'Chungnam National University, Daejeon, Republic of Korea.'}, {'ForeName': 'Hwa-Seung', 'Initials': 'HS', 'LastName': 'Yoo', 'Affiliation': 'Seoul Korean Medicine Hospital of Daejeon University, Seoul, Republic of Korea.'}]",Integrative cancer therapies,['10.1177/1534735420925519']
1760,22624097,Comparison of ketamine with fentanyl as co-induction in propofol anesthesia for short surgical procedures.,"BACKGROUND AND OBJECTIVE


A prospective randomized control study was conducted to compare and evaluate quality of anesthesia with ketamine or fentanyl as co-induction with propofol.
MATERIALS AND METHODS


Sixty ASA I or II, 18-50 year old patients who were scheduled for minor surgeries of short duration (<30 min anticipated duration) were selected. The patients were randomly allocated to group I and group II comprising 30 patients each. The patients of group I were given ketamine injection 0.5 mg/kg and group II patients fentanyl injection (1.5 μg/kg) as co-induction agent. Two minutes later, induction of anesthesia was given with inj propofol (2.5 mg/kg) and appropriate-sized laryngeal mask airway was inserted. The anesthesia was maintained with 60% N(2)O in O(2) and intermittent bolus of inj propofol (0.5 mg/kg) after observing significant changes in the heart rate, blood pressure, lacrimation, sweating, and abnormal movements.
RESULTS


There was significant decrease (P<0.05) in the pulse rate, systolic and diastolic blood pressure at 1, 3, and 5 min in group II (fentanyl group) whereas the change was insignificant (P>0.05) at 10 min.
CONCLUSION


It was observed that ketamine as premedicant was better than fentanyl with respect to hemodynamic stability and caused less adverse effects intraoperatively and postoperatively.",2012,"There was significant decrease (P<0.05) in the pulse rate, systolic and diastolic blood pressure at 1, 3, and 5 min in group II (fentanyl group) whereas the change was insignificant (P>0.05) at 10 min.
","['Sixty ASA I or II, 18-50 year old patients who were scheduled for minor surgeries of short duration (<30 min anticipated duration) were selected']","['ketamine with fentanyl', 'inj propofol', 'ketamine or fentanyl', 'propofol anesthesia', 'ketamine', 'ketamine injection 0.5 mg/kg and group II patients fentanyl injection']","['heart rate, blood pressure, lacrimation, sweating, and abnormal movements', 'pulse rate, systolic and diastolic blood pressure']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0038904', 'cui_str': 'Minor Surgery'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4080610', 'cui_str': 'Fentanyl Injection [Sublimaze]'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0423153', 'cui_str': 'Lacrimation'}, {'cui': 'C0558189', 'cui_str': 'Abnormal movement (finding)'}, {'cui': 'C0232117', 'cui_str': 'Pulse Rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}]",60.0,0.0208023,"There was significant decrease (P<0.05) in the pulse rate, systolic and diastolic blood pressure at 1, 3, and 5 min in group II (fentanyl group) whereas the change was insignificant (P>0.05) at 10 min.
","[{'ForeName': 'Ritu', 'Initials': 'R', 'LastName': 'Goyal', 'Affiliation': 'Department of Anaesthesiology, Saraswati Institute of Medical Sciences, Hapur, Ghaziabad, Uttar Pradesh, India.'}, {'ForeName': 'Manpreet', 'Initials': 'M', 'LastName': 'Singh', 'Affiliation': ''}, {'ForeName': 'Jaiprakash', 'Initials': 'J', 'LastName': 'Sharma', 'Affiliation': ''}]",International journal of critical illness and injury science,['10.4103/2229-5151.94890']
1761,22613054,Evaluation of buspirone for relapse-prevention in adults with cocaine dependence: an efficacy trial conducted in the real world.,"Cocaine dependence is a significant public health problem for which there are currently no FDA-approved medications. Hence, identifying candidate compounds and employing an efficient evaluation process is crucial. This paper describes key design decisions made for a National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) study that uses a novel two-stage process to evaluate buspirone (60 mg/day) for cocaine-relapse prevention. The study includes pilot (N=60) and full-scale (estimated N=264) trials. Both trials will be randomized, double-blind, and placebo-controlled and both will enroll treatment-seeking cocaine-dependent participants engaged in inpatient/residential treatment and scheduled for outpatient treatment post-discharge. All participants will receive contingency management in which incentives are given for medication adherence as evaluated by the Medication Events Monitoring System (MEMS). The primary outcome measure is maximum days of continuous cocaine abstinence, as assessed by twice-weekly urine drug screens (UDS) and self-report, during the 15-week outpatient treatment phase. Drug-abuse outcomes include cocaine use as assessed by UDS and self-report of cocaine use, other substance use as assessed by UDS and self-report of substance use (i.e., alcohol and/or illicit drugs), cocaine bingeing, HIV risk behavior, quality of life, functioning, and substance abuse treatment attendance. Unique aspects of the study include conducting an efficacy trial in community treatment programs, a two-stage process to efficiently evaluate buspirone, and an evaluation of mediators by which buspirone might exert a beneficial effect on relapse prevention.",2012,All participants will receive contingency management in which incentives are given for medication adherence as evaluated by the Medication Events Monitoring System (MEMS).,"['participants engaged in inpatient/residential treatment and scheduled for outpatient treatment post-discharge', 'National Institute on Drug Abuse (NIDA', 'adults with cocaine dependence']","['buspirone', 'placebo']","['UDS and self-report of substance use (i.e., alcohol and/or illicit drugs), cocaine bingeing, HIV risk behavior, quality of life, functioning, and substance abuse treatment attendance', 'maximum days of continuous cocaine abstinence, as assessed by twice-weekly urine drug screens (UDS) and self-report, during the 15-week outpatient treatment phase']","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0035189', 'cui_str': 'Residential Treatment'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1513899', 'cui_str': 'NIDA (US)'}, {'cui': 'C0068218', 'cui_str': 'NIDA'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0600427', 'cui_str': 'Cocaine Dependence'}]","[{'cui': 'C0006462', 'cui_str': 'Buspirone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0086190', 'cui_str': 'Illicit Drugs'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0034380'}, {'cui': 'C0740858', 'cui_str': 'Substance Abuse'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]",,0.0762513,All participants will receive contingency management in which incentives are given for medication adherence as evaluated by the Medication Events Monitoring System (MEMS).,"[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, OH 45220, USA. winhusen@carc.uc.edu'}, {'ForeName': 'Kathleen T', 'Initials': 'KT', 'LastName': 'Brady', 'Affiliation': ''}, {'ForeName': 'Maxine', 'Initials': 'M', 'LastName': 'Stitzer', 'Affiliation': ''}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Woody', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lindblad', 'Affiliation': ''}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Kropp', 'Affiliation': ''}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Brigham', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Sparenborg', 'Affiliation': ''}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Sharma', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Vanveldhuisen', 'Affiliation': ''}, {'ForeName': 'Bryon', 'Initials': 'B', 'LastName': 'Adinoff', 'Affiliation': ''}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Somoza', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2012.05.003']
1762,22781166,"Patients' beliefs about the causes, persistence and control of psychotic experiences predict take-up of effective cognitive behaviour therapy for psychosis.","BACKGROUND


There is evidence that patients with schizophrenia benefit from standard cognitive behaviour therapy (CBT) only if active techniques are used ('full therapy'). By contrast, attending sessions but not proceeding beyond engagement and assessment strategies ('partial therapy'), or simply not attending sessions ('no therapy'), is not associated with better outcomes. The factors leading to full therapy are unknown. We hypothesized that patients' initial ideas about the nature and extent of their problems would predict use of CBT. A match between patients' views of their problems and the principles underlying treatment would lead to better outcomes.
METHOD


Ninety-two patients with a recent relapse of psychosis completed the Illness Perception Questionnaire (IPQ) before receiving CBT. We examined whether their illness perceptions predicted the take-up of therapy.
RESULTS


Patients who did not attend sessions believed their problems would not last as long as those who attended them. Those who attended sessions but did not proceed to full therapy had a lower sense of control over their problems and a more biological view of their causes. Patients who took up full therapy were more likely to attribute the cause of their problems to their personality and state of mind. The take-up of therapy was predicted neither by levels of psychiatric symptoms nor by insight.
CONCLUSIONS


People with psychosis who have psychologically orientated views of their problems, including the potential to gain control over them, may be more likely to engage fully and do well with standard CBT for psychosis, irrespective of the severity of their problems.",2013,Those who attended sessions but did not proceed to full therapy had a lower sense of control over their problems and a more biological view of their causes.,"['Ninety-two patients with a recent relapse of psychosis completed the Illness Perception Questionnaire (IPQ) before receiving CBT', 'patients with schizophrenia benefit from']",['standard cognitive behaviour therapy (CBT'],[],"[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]",[],92.0,0.0275536,Those who attended sessions but did not proceed to full therapy had a lower sense of control over their problems and a more biological view of their causes.,"[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Freeman', 'Affiliation': 'Department of Psychiatry, Oxford University, UK. daniel.freeman@psych.ox.ac.uk'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Dunn', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Garety', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Weinman', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kuipers', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Fowler', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Jolley', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bebbington', 'Affiliation': ''}]",Psychological medicine,['10.1017/S0033291712001225']
1763,32422956,Traditional Brazilian Diet and Olive Oil Reduce Cardiometabolic Risk Factors in Severely Obese Individuals: A Randomized Trial.,"Cardioprotective effects associated with extra virgin olive oil (EVOO) have been studied within the Mediterranean diet. However, little is known about its consumption in the traditional Brazilian diet (DieTBra) or without any dietary prescription, particularly in severely obese individuals. This study aimed to assess the effectiveness of DieTBra and EVOO in cardiometabolic risk factor (CMRF) reduction in severely obese individuals. We conducted a parallel randomized clinical trial with 149 severely obese individuals (body mass index ≥ 35.0 kg/m 2 ) aged 18-65 years, assigned to three groups: 52 mL/day of EVOO ( n  = 50), DieTBra ( n  = 49), and DieTBra + 52 mL/day of EVOO ( n  = 50). Participants were followed up for 12 weeks. Low-density lipoprotein cholesterol (LDL-c) was the primary endpoint and several cardiometabolic parameters were secondary endpoints. Endpoints were compared at baseline and at the end of the study using analysis of variance, the Kruskal-Wallis test, and Student's  t -test. The TC/High-density lipoprotein (HDL) ratio (-0.33 ± 0.68,  p  = 0.002) and LDL/HDL ratio (-0.26 ± 0.59,  p  = 0.005) decreased in the EVOO group. Delta values for all variables showed no significant statistical difference between groups. However, we highlight the clinical significance of LDL-c reduction in the EVOO group by 5.11 ± 21.79 mg/dL and in the DieTBra group by 4.27 ± 23.84 mg/dL. We also found a mean reduction of around 10% for Castelli II (LDL/HDL) and homocysteine in the EVOO group and TG and the TG/HDL ratio in the DieTBra group. EVOO or DieTBra when administered alone lead to reduction in some cardiometabolic risk parameters in severely obese individuals.",2020,Delta values for all variables showed no significant statistical difference between groups.,"['Severely Obese Individuals', 'severely obese individuals', '149 severely obese individuals (body mass index ≥ 35.0 kg/m 2 ) aged 18-65 years']","['DieTBra and EVOO', 'extra virgin olive oil (EVOO', 'EVOO or DieTBra', 'Traditional Brazilian Diet and Olive Oil']","['cardiometabolic risk factor (CMRF) reduction', 'cardiometabolic risk parameters', 'LDL/HDL ratio', 'Delta values', 'TC/High-density lipoprotein (HDL) ratio', 'Low-density lipoprotein cholesterol (LDL-c', 'TG/HDL ratio']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1171408', 'cui_str': 'High density/low density lipoprotein ratio measurement'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}]",149.0,0.0600881,Delta values for all variables showed no significant statistical difference between groups.,"[{'ForeName': 'Annelisa Silva E Alves de Carvalho', 'Initials': 'ASEAC', 'LastName': 'Santos', 'Affiliation': 'Programa de Pós-Graduação em Ciências da Saúde, Faculdade de Medicina, Universidade Federal de Goiás, Goiânia 74.650-050, GO, Brazil.'}, {'ForeName': 'Ana Paula Dos Santos', 'Initials': 'APDS', 'LastName': 'Rodrigues', 'Affiliation': 'Programa de Pós-Graduação em Ciências da Saúde, Faculdade de Medicina, Universidade Federal de Goiás, Goiânia 74.650-050, GO, Brazil.'}, {'ForeName': 'Lorena Pereira de Souza', 'Initials': 'LPS', 'LastName': 'Rosa', 'Affiliation': 'Programa de Pós-Graduação em Ciências da Saúde, Faculdade de Medicina, Universidade Federal de Goiás, Goiânia 74.650-050, GO, Brazil.'}, {'ForeName': 'Matias', 'Initials': 'M', 'LastName': 'Noll', 'Affiliation': 'Programa de Pós-Graduação em Ciências da Saúde, Faculdade de Medicina, Universidade Federal de Goiás, Goiânia 74.650-050, GO, Brazil.'}, {'ForeName': 'Erika Aparecida', 'Initials': 'EA', 'LastName': 'Silveira', 'Affiliation': 'Programa de Pós-Graduação em Ciências da Saúde, Faculdade de Medicina, Universidade Federal de Goiás, Goiânia 74.650-050, GO, Brazil.'}]",Nutrients,['10.3390/nu12051413']
1764,32422942,The Effect of Ursodeoxycholic Acid on Small Intestinal Bacterial Overgrowth in Patients with Functional Dyspepsia: A Pilot Randomized Controlled Trial.,"Functional dyspepsia (FD) is associated with small intestinal bacterial overgrowth (SIBO). Several animal studies have reported that ursodeoxycholic acid (UDCA) has antibacterial and anti-inflammatory effects in the intestine. We hypothesized that UDCA may be effective against dyspeptic symptoms and SIBO in patients with FD. We conducted this randomized controlled trial to investigate the effects of UDCA in FD patients with SIBO. Twenty-four patients diagnosed with FD and SIBO based on lactulose breath test (LBT) were randomly assigned to either a UDCA treatment group or an untreated group. The treatment group received 100 mg of UDCA three times per day for two months; the untreated group was monitored for two months without intervention. After two months in both groups, we reevaluated LBT and FD symptoms using the Nepean dyspepsia index-K. FD symptoms in the UDCA-treated group were significantly reduced after two months compared with baseline and FD symptom scores between the UDCA-treated and untreated groups showed statistically significant differences after two months. In addition, the total methane gas levels for 90 minutes in LBT were significantly decreased after two months compared with baseline in the UDCA-treated group. In this preliminary exploratory study, we found that two months of UDCA treatment resulted in FD symptom improvement and reduced methane values during 90 minutes on the LBT, suggesting that methane-producing SIBO were associated with symptoms of dyspepsia and that UDCA was helpful in these patients. These findings need to be validated via large-scale controlled and well-designed studies.",2020,"In addition, the total methane gas levels for 90 minutes in LBT were significantly decreased after two months compared with baseline in the UDCA-treated group.","['Twenty-four patients diagnosed with FD and SIBO based on lactulose breath test (LBT', 'FD patients with SIBO', 'Patients with Functional Dyspepsia', 'patients with FD']","['UDCA treatment group or an untreated group', 'Ursodeoxycholic Acid', 'ursodeoxycholic acid (UDCA', 'UDCA']","['FD symptom improvement and reduced methane values', 'Functional dyspepsia (FD', 'Small Intestinal Bacterial Overgrowth', 'LBT and FD symptoms using the Nepean dyspepsia index-K. FD symptoms', 'total methane gas levels', 'FD symptom scores']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C3160854', 'cui_str': 'Small intestinal bacterial overgrowth'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0022957', 'cui_str': 'Lactulose'}, {'cui': 'C0006153', 'cui_str': 'Breath test'}]","[{'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}]","[{'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0025617', 'cui_str': 'Methane'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C3160854', 'cui_str': 'Small intestinal bacterial overgrowth'}, {'cui': 'C0022957', 'cui_str': 'Lactulose'}, {'cui': 'C0006153', 'cui_str': 'Breath test'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",24.0,0.0623256,"In addition, the total methane gas levels for 90 minutes in LBT were significantly decreased after two months compared with baseline in the UDCA-treated group.","[{'ForeName': 'Bom-Taeck', 'Initials': 'BT', 'LastName': 'Kim', 'Affiliation': 'Department of Family Practice and Community Health, Ajou University School of Medicine, Suwon 16499, Korea.'}, {'ForeName': 'Kwang-Min', 'Initials': 'KM', 'LastName': 'Kim', 'Affiliation': 'Department of Family Practice and Community Health, Ajou University School of Medicine, Suwon 16499, Korea.'}, {'ForeName': 'Kyu-Nam', 'Initials': 'KN', 'LastName': 'Kim', 'Affiliation': 'Department of Family Practice and Community Health, Ajou University School of Medicine, Suwon 16499, Korea.'}]",Nutrients,['10.3390/nu12051410']
1765,31860107,Effect of Teaching Bayesian Methods Using Learning by Concept vs Learning by Example on Medical Students' Ability to Estimate Probability of a Diagnosis: A Randomized Clinical Trial.,"Importance


Clinicians use probability estimates to make a diagnosis. Teaching students to make more accurate probability estimates could improve the diagnostic process and, ultimately, the quality of medical care.
Objective


To test whether novice clinicians can be taught to make more accurate bayesian revisions of diagnostic probabilities using teaching methods that apply either explicit conceptual instruction or repeated examples.
Design, Setting, and Participants


A randomized clinical trial of 2 methods for teaching bayesian updating and diagnostic reasoning was performed. A web-based platform was used for consent, randomization, intervention, and testing of the effect of the intervention. Participants included 61 medical students at McMaster University and Eastern Virginia Medical School recruited from May 1 to September 30, 2018.
Interventions


Students were randomized to (1) receive explicit conceptual instruction regarding diagnostic testing and bayesian revision (concept group), (2) exposure to repeated examples of cases with feedback regarding posttest probability (experience group), or (3) a control condition with no conceptual instruction or repeated examples.
Main Outcomes and Measures


Students in all 3 groups were tested on their ability to update the probability of a diagnosis based on either negative or positive test results. Their probability revisions were compared with posttest probability revisions that were calculated using the Bayes rule and known test sensitivity and specificity.
Results


Of the 61 participants, 22 were assigned to the concept group, 20 to the experience group, and 19 to the control group. Approximate age was 25 years. Two participants were first-year; 37, second-year; 12, third-year; and 10, fourth-year students. Mean (SE) probability estimates of students in the concept group were statistically significantly closer to calculated bayesian probability than the other 2 groups (concept, 0.4%; [0.7%]; experience, 3.5% [0.7%]; control, 4.3% [0.7%]; P < .001). Although statistically significant, the differences between groups were relatively modest, and students in all groups performed better than expected, based on prior reports in the literature.
Conclusions and Relevance


The study showed a modest advantage for students who received theoretical instruction on bayesian concepts. All participants' probability estimates were, on average, close to the bayesian calculation. These findings have implications for how to teach diagnostic reasoning to novice clinicians.
Trial Registration


ClinicalTrials.gov identifier: NCT04130607.",2019,"Mean (SE) probability estimates of students in the concept group were statistically significantly closer to calculated bayesian probability than the other 2 groups (concept, 0.4%; [0.7%]; experience, 3.5% [0.7%]; control, 4.3% [0.7%]; P < .001).","['61 participants', 'Participants included 61 medical students at McMaster University and Eastern Virginia Medical School recruited from May 1 to September 30, 2018', 'Two participants were first-year; 37, second-year; 12, third-year; and 10, fourth-year students']","['explicit conceptual instruction regarding diagnostic testing and bayesian revision (concept group), (2) exposure to repeated examples of cases with feedback regarding posttest probability (experience group), or (3) a control condition with no conceptual instruction or repeated examples', 'Teaching Bayesian Methods Using Learning by Concept vs Learning by Example']","['Mean (SE) probability estimates', 'probability of a diagnosis based on either negative or positive test results', 'calculated bayesian probability']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0042753', 'cui_str': 'Virginia'}, {'cui': 'C0036378', 'cui_str': 'Schools, Medical'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0242198', 'cui_str': 'Bayesian Method'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",61.0,0.049877,"Mean (SE) probability estimates of students in the concept group were statistically significantly closer to calculated bayesian probability than the other 2 groups (concept, 0.4%; [0.7%]; experience, 3.5% [0.7%]; control, 4.3% [0.7%]; P < .001).","[{'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Brush', 'Affiliation': 'Cardiology Division, Department of Internal Medicine, Eastern Virginia Medical School, Sentara Healthcare, Norfolk.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'McMaster Education Research, Innovation and Theory Program, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Sherbino', 'Affiliation': 'McMaster Education Research, Innovation and Theory Program, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Judith C', 'Initials': 'JC', 'LastName': 'Taylor-Fishwick', 'Affiliation': 'Cardiology Division, Department of Internal Medicine, Eastern Virginia Medical School, Sentara Healthcare, Norfolk.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Norman', 'Affiliation': 'McMaster Education Research, Innovation and Theory Program, McMaster University, Hamilton, Ontario, Canada.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.18023']
1766,32423007,Influence of a Lubricating Gel (Orthospeed®) on Pain and Oral Health-Related Quality of Life in Orthodontic Patients during Initial Therapy with Conventional and Low-Friction Brackets: A Prospective Randomized Clinical Trial.,"The aim of this study was to investigate whether statistically significant differences exist regarding pain and the impact on oral quality of life of orthodontic treatment. A conventional brackets system was compared with low-friction brackets. A total of 90 patients (male = 35, female = 55) were chosen for this randomized clinical trial. Pain was assessed at 4, 8, and 24 hours and 2, 3, 4, 5, 6, and 7 days after the start of treatment using the McGill Pain Questionnaire. Oral health-related quality of life (OHRQoL) was assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire. Oral quality of life was assessed at one month, with patients with low-friction brackets describing lower levels of pain. The patients with conventional brackets indicated a worse impact on their quality of life compared to the group with low-friction brackets. Statistically significant differences were found between the groups, with maximum pain observed between the first 24 and 48 hours, and the values of minimum pain are reached after 7 days. The pain and impact on oral quality of life was statistically worse in patients with conventional brackets compared to patients with low-friction brackets. The type of bracket system used was therefore shown to influence patients' perceptions of pain and impact on their OHRQoL.",2020,The patients with conventional brackets indicated a worse impact on their quality of life compared to the group with low-friction brackets.,"['Orthodontic Patients during Initial Therapy with Conventional and Low-Friction Brackets', '90 patients (male = 35, female = 55']","['Lubricating Gel (Orthospeed®', 'OHRQoL']","['quality of life', 'Oral health-related quality of life (OHRQoL', 'Oral quality of life', 'Pain', 'Oral Health Impact Profile-14 (OHIP-14) questionnaire', 'values of minimum pain', 'pain', 'oral quality of life of orthodontic treatment', 'oral quality of life', 'Pain and Oral Health-Related Quality of Life', 'maximum pain', 'McGill Pain Questionnaire']","[{'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0162691', 'cui_str': 'Friction'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}]",90.0,0.0922206,The patients with conventional brackets indicated a worse impact on their quality of life compared to the group with low-friction brackets.,"[{'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Curto', 'Affiliation': 'DDS, Professor in Pediatric Dentistry, Faculty of Medicine, University of Salamanca, Avenida Alfonso X el Sabio s/n. 37007 Salamanca, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Albaladejo', 'Affiliation': 'DDS, Professor in Orthodontics, Faculty of Medicine, University of Salamanca, Avenida Alfonso X el Sabio s/n. 37007 Salamanca, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Montero', 'Affiliation': 'DDS, Professor in Prosthodontics, Faculty of Medicine, University of Salamanca, Avenida Alfonso X el Sabio s/n. 37007 Salamanca, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Alvarado', 'Affiliation': 'DDS, Professor in Orthodontics, Faculty of Medicine, University of Salamanca, Avenida Alfonso X el Sabio s/n. 37007 Salamanca, Spain.'}]",Journal of clinical medicine,['10.3390/jcm9051474']
1767,31701481,"Elotuzumab plus lenalidomide and dexamethasone for newly diagnosed multiple myeloma: a randomized, open-label, phase 2 study in Japan.","Novel therapies are needed for patients with newly diagnosed multiple myeloma (NDMM). Elotuzumab plus lenalidomide and dexamethasone (ELd) is approved for the treatment of relapsed/refractory multiple myeloma (RRMM). This phase 2 study in Japan evaluated ELd vs lenalidomide and dexamethasone (Ld) in patients with NDMM who were ineligible for stem cell transplantation. Elotuzumab infusion was accelerated to 5 mL/min by dose 3, cycle 1, allowing most subsequent infusions to be completed within 1 h. The primary endpoint was overall response rate (ORR) in the ELd arm. Secondary endpoints were the difference in ORR between treatments, and progression-free survival (PFS). Patients were randomized to ELd (n = 40) or Ld (n = 42); median number of treatment cycles was 13 (ELd) and 12 (Ld). In the ELd arm, ORR was 88% [70% confidence interval (CI) 80-93]. The estimated difference in ORR between treatments was 13% (95% CI  - 4, 30) in favor of ELd. Progression-free survival data were immature. Safety was consistent with previous findings of ELd in Japanese patients with RRMM. No infusion reactions occurred at the maximum rate of 5 mL/min, which was used in 89% of elotuzumab infusions. ELd may be an effective, well-tolerated frontline treatment for patients with NDMM ineligible for stem cell transplantation.",2020,"In the ELd arm, ORR was 88% [70% confidence interval (CI) 80-93].","['newly diagnosed multiple myeloma', 'patients with newly diagnosed multiple myeloma (NDMM', 'patients with NDMM ineligible for stem cell transplantation', 'patients with NDMM who were ineligible for stem cell transplantation', 'Japanese patients with RRMM', 'relapsed/refractory multiple myeloma (RRMM']","['Elotuzumab', 'ELd vs lenalidomide and dexamethasone (Ld', 'Elotuzumab plus lenalidomide and dexamethasone', 'Elotuzumab plus lenalidomide and dexamethasone (ELd', 'ELd']","['ORR', 'Progression-free survival data', 'ORR between treatments, and progression-free survival (PFS', 'overall response rate (ORR', 'infusion reactions']","[{'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}]","[{'cui': 'C1832049', 'cui_str': 'elotuzumab'}, {'cui': 'C0331055', 'cui_str': 'Elder Plant'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2368034', 'cui_str': 'Adverse reaction caused by drug or medicament administered by infusion'}]",,0.117776,"In the ELd arm, ORR was 88% [70% confidence interval (CI) 80-93].","[{'ForeName': 'Kohmei', 'Initials': 'K', 'LastName': 'Kubo', 'Affiliation': 'Department of Hematology, Aomori Prefectural Central Hospital, 2-1-1 Higashi-Tsukurimichi, Aomori, 030-8553, Japan. komei.kubo@nifty.com.'}, {'ForeName': 'Mitsuo', 'Initials': 'M', 'LastName': 'Hori', 'Affiliation': 'Department of Hematology, Ibaraki Prefectural Central Hospital, Kasama, Japan.'}, {'ForeName': 'Kensuke', 'Initials': 'K', 'LastName': 'Ohta', 'Affiliation': 'Department of Hematology, Osaka Saiseikai Nakatsu Hospital, Osaka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Handa', 'Affiliation': 'Department of Hematology, Gunma University Hospital, Maebashi, Japan.'}, {'ForeName': 'Kiyohiko', 'Initials': 'K', 'LastName': 'Hatake', 'Affiliation': 'Department of Lymphoma/Hematologic Malignancy Center, Mita Hospital, International University of Health and Welfare, Tokyo, Japan.'}, {'ForeName': 'Morio', 'Initials': 'M', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Hematology, National Hospital Organization Shibukawa Medical Center, Shibukawa, Japan.'}, {'ForeName': 'Shotaro', 'Initials': 'S', 'LastName': 'Hagiwara', 'Affiliation': 'Division of Hematology, Internal Medicine, National Center for Global Health and Medicine Hospital, Tokyo, Japan.'}, {'ForeName': 'Kazuteru', 'Initials': 'K', 'LastName': 'Ohashi', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.'}, {'ForeName': 'Chiaki', 'Initials': 'C', 'LastName': 'Nakaseko', 'Affiliation': 'Department of Hematology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Kenshi', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'Department of Hematology, Japanese Red Cross Medical Center, Tokyo, Japan.'}, {'ForeName': 'Shigeki', 'Initials': 'S', 'LastName': 'Ito', 'Affiliation': 'Department of Clinical Oncology, Iwate Medical University Hospital, Morioka, Japan.'}, {'ForeName': 'Gen', 'Initials': 'G', 'LastName': 'Kinoshita', 'Affiliation': 'Bristol-Myers Squibb K.K., Tokyo, Japan.'}, {'ForeName': 'Suresh G', 'Initials': 'SG', 'LastName': 'Shelat', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Miyoshi', 'Affiliation': 'Bristol-Myers Squibb K.K., Tokyo, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Takezako', 'Affiliation': 'Department of Hematology, National Hospital Organization Disaster Medical Center, Tokyo, Japan.'}]",International journal of hematology,['10.1007/s12185-019-02757-0']
1768,32036492,Randomized phase II/III study of 5-fluorouracil/l-leucovorin versus 5-fluorouracil/l-leucovorin plus paclitaxel administered to patients with severe peritoneal metastases of gastric cancer (JCOG1108/WJOG7312G).,"BACKGROUND


Oral fluoropyrimidine plus cisplatin is often not tolerated by patients with severe peritoneal metastases of gastric cancer. Combination of 5-fluorouracil (5-FU), l-leucovorin (l-LV), and paclitaxel (FLTAX) has promising activity for such patients. We conducted a phase II/III study comparing FLTAX with 5-FU/l-LV.
METHODS


Eligibility criteria included: unresectable or recurrent gastric adenocarcinoma; 20-75 years; performance status (PS) 0-2; peritoneal metastases + ; massive ascites and/or inadequate oral intake; no prior chemotherapy. Patients were randomly assigned to receive 5-FU/l-LV or FLTAX. The primary endpoint of phase III was overall survival: UMIN000010949.
RESULTS


We enrolled 101 patients. Early deaths occurred in patients with PS 2 having massive ascites and inadequate oral intake simultaneously; the protocol was amended to exclude such patients. Median survival times were 6.1 and 7.3 months for the 5-FU/l-LV and the FLTAX arms, respectively (HR 0.792; 80% CI 0.596-1.053; one-sided p = 0.1445). FLTAX arm had longer progression-free survival (PFS) [1.9 vs 5.4 months (HR 0.64; 95% CI, 0.43-0.96; p = 0.029)]. Grade 3/4 adverse events such as leucopenia and anorexia were more frequently observed in the 5-FU/l-LV arm. In the 5-FU/l-LV arm, two deaths were treatment-related. In the 5-FU/l-LV and FLTAX arms, 12 and 3 deaths occurred within 30 days after the last protocol treatment, respectively.
CONCLUSIONS


Chemotherapy was indicated for patients with severe peritoneal metastases excluding patients with PS 2 having massive ascites and inadequate oral intake simultaneously. FLTAX did not confer a significant survival benefit but may be preferred because of longer PFS and acceptable toxicity.",2020,"FLTAX arm had longer progression-free survival (PFS) [1.9 vs 5.4 months (HR 0.64; 95% CI, 0.43-0.96; p = 0.029)].","['We enrolled 101 patients', 'patients with severe peritoneal metastases of gastric cancer', 'patients with severe peritoneal metastases excluding patients with PS 2 having massive ascites and inadequate oral intake simultaneously', 'patients with severe peritoneal metastases of gastric cancer (JCOG1108/WJOG7312G', 'Eligibility criteria included: unresectable or recurrent gastric adenocarcinoma; 20-75\xa0years; performance status (PS) 0-2; peritoneal metastases\u2009+\u2009; massive ascites and/or inadequate oral intake; no prior chemotherapy']","['FLTAX with 5-FU/l-LV', 'FLTAX', '5-fluorouracil/l-leucovorin versus 5-fluorouracil/l-leucovorin plus paclitaxel', '5-FU/l-LV or FLTAX', '5-FU/l-LV and FLTAX', '5-FU/l-LV', 'fluoropyrimidine plus cisplatin', '5-fluorouracil (5-FU), l-leucovorin (l-LV), and paclitaxel (FLTAX']","['Early deaths', 'Median survival times', 'Grade 3/4 adverse events such as leucopenia and anorexia', 'longer progression-free survival (PFS', 'overall survival: UMIN000010949']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0346989', 'cui_str': 'Secondary malignant peritoneal deposit'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C3714435', 'cui_str': 'Inadequate oral intake (finding)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",101.0,0.0523077,"FLTAX arm had longer progression-free survival (PFS) [1.9 vs 5.4 months (HR 0.64; 95% CI, 0.43-0.96; p = 0.029)].","[{'ForeName': 'Takako Eguchi', 'Initials': 'TE', 'LastName': 'Nakajima', 'Affiliation': 'Department of Clinical Oncology, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan. tnakajima@marianna-u.ac.jp.'}, {'ForeName': 'Kensei', 'Initials': 'K', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Gastroenterology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Narikazu', 'Initials': 'N', 'LastName': 'Boku', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Ichinosuke', 'Initials': 'I', 'LastName': 'Hyodo', 'Affiliation': 'Department of Gastroenterology, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Junki', 'Initials': 'J', 'LastName': 'Mizusawa', 'Affiliation': 'Japan Clinical Oncology Group (JCOG) Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Gastroenterology, Saitama Cancer Center, Saitama, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Nishina', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Gastroenterology, Hyogo Cancer Center, Akashi, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Shitara', 'Affiliation': 'Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Katsunori', 'Initials': 'K', 'LastName': 'Shinozaki', 'Affiliation': 'Division of Clinical Oncology, Hiroshima Prefectural Hospital, Hiroshima, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Katayama', 'Affiliation': 'Japan Clinical Oncology Group (JCOG) Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Nakamura', 'Affiliation': 'West Japan Oncology Group (WJOG) Data Center Division, Yokohama, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center, Nagoya, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Terashima', 'Affiliation': 'Department of Gastrointestinal Oncology, Shizuoka Cancer Center, Nagaizumi, Japan.'}]",Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association,['10.1007/s10120-020-01043-x']
1769,32281393,Impact of Cardiac Implantable Electronic Device Infection: A Clinical and Economic Analysis of the WRAP-IT Trial.,"BACKGROUND


Current understanding of the impact of cardiac implantable electronic device (CIED) infection is based on retrospective analyses from medical records or administrative claims data. The WRAP-IT (Worldwide Randomized Antibiotic Envelope Infection Prevention Trial) offers an opportunity to evaluate the clinical and economic impacts of CIED infection from the hospital, payer, and patient perspectives in the US healthcare system.
METHODS


This was a prespecified, as-treated analysis evaluating outcomes related to major CIED infections: mortality, quality of life, disruption of CIED therapy, healthcare utilization, and costs. Payer costs were assigned using medicare fee for service national payments, while medicare advantage, hospital, and patient costs were derived from similar hospital admissions in administrative datasets.
RESULTS


Major CIED infection was associated with increased all-cause mortality (12-month risk-adjusted hazard ratio, 3.41 [95% CI, 1.81-6.41];  P <0.001), an effect that sustained beyond 12 months (hazard ratio through all follow-up, 2.30 [95% CI, 1.29-4.07];  P =0.004). Quality of life was reduced ( P =0.004) and did not normalize for 6 months. Disruptions in CIED therapy were experienced in 36% of infections for a median duration of 184 days. Mean costs were $55 547±$45 802 for the hospital, $26 867±$14 893, for medicare fee for service and $57 978±$29 431 for Medicare Advantage (mean hospital margin of -$30 828±$39 757 for medicare fee for service and -$6055±$45 033 for medicare advantage). Mean out-of-pocket costs for patients were $2156±$1999 for medicare fee for service, and $1658±$1250 for medicare advantage.
CONCLUSIONS


This large, prospective analysis corroborates and extends understanding of the impact of CIED infections as seen in real-world datasets. CIED infections severely impact mortality, quality of life, healthcare utilization, and cost in the US healthcare system. Registration: URL: https://www.clinicaltrials.gov Unique Identifier: NCT02277990.",2020,Quality of life was reduced ( P =0.004) and did not normalize for 6 months.,['978±$29\u2009431 for Medicare Advantage'],"['Registration: URL', 'Cardiac Implantable Electronic Device Infection', 'cardiac implantable electronic device (CIED) infection']","['mortality, quality of life, healthcare utilization, and cost', 'Mean costs', 'Payer costs', 'major CIED infections: mortality, quality of life, disruption of CIED therapy, healthcare utilization, and costs', 'Quality of life', 'cause mortality']","[{'cui': 'C2713369', 'cui_str': 'Medicare advantage coverage'}]","[{'cui': 'C3541384', 'cui_str': 'URL'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C1504335', 'cui_str': 'Device therapy'}]",,0.150794,Quality of life was reduced ( P =0.004) and did not normalize for 6 months.,"[{'ForeName': 'Bruce L', 'Initials': 'BL', 'LastName': 'Wilkoff', 'Affiliation': 'Department of Cardiovascular Medicine and Heart and Vascular Institute, Cleveland Clinic, OH (B.L.W., K.G.T.).'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Boriani', 'Affiliation': 'Clinical and Public Health Medicine, University of Modena and Reggio Emilia, Modena, Italy (G.B.).'}, {'ForeName': 'Suneet', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': 'Department of Cardiology, Section of Electrophysiology, Valley Health System, Ridgewood, NJ (S.M.).'}, {'ForeName': 'Jeanne E', 'Initials': 'JE', 'LastName': 'Poole', 'Affiliation': 'Department of Medicine, University of Washington School of Medicine, Seattle (J.E.P.).'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Kennergren', 'Affiliation': 'The Sahlgrenska Academy, University of Göteborg, Sweden (C.K.).'}, {'ForeName': 'G Ralph', 'Initials': 'GR', 'LastName': 'Corey', 'Affiliation': 'Department of Medicine, Duke Clinical Research Institute, Durham, NC (G.R.C.).'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Love', 'Affiliation': 'Maine Medical Partners, Maine Medical Center, Portland (J.C.L.).'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Augostini', 'Affiliation': 'Department of Internal Medicine, Ohio State University, Columbus (R.A.).'}, {'ForeName': 'Svein', 'Initials': 'S', 'LastName': 'Faerestrand', 'Affiliation': 'Department of Heart Disease, University of Bergen and Haukeland University Hospital, Norway (S.F.).'}, {'ForeName': 'Sherman S', 'Initials': 'SS', 'LastName': 'Wiggins', 'Affiliation': 'ARK-LA-TEX Cardiology, Christus Highland Hospital, Shreveport, LA (S.S.W.).'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Healey', 'Affiliation': 'Population Health Research Institute, McMaster University, ON, Canada (J.S.H.).'}, {'ForeName': 'Reece', 'Initials': 'R', 'LastName': 'Holbrook', 'Affiliation': 'Cardiac Rhythm & Heart Failure (CRHF) Therapy Development and Clinical Research, Medtronic, Mounds View, MN (R.H., J.D.L., D.R.L., S.W.).'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Lande', 'Affiliation': 'Cardiac Rhythm & Heart Failure (CRHF) Therapy Development and Clinical Research, Medtronic, Mounds View, MN (R.H., J.D.L., D.R.L., S.W.).'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Lexcen', 'Affiliation': 'Cardiac Rhythm & Heart Failure (CRHF) Therapy Development and Clinical Research, Medtronic, Mounds View, MN (R.H., J.D.L., D.R.L., S.W.).'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Willey', 'Affiliation': 'Cardiac Rhythm & Heart Failure (CRHF) Therapy Development and Clinical Research, Medtronic, Mounds View, MN (R.H., J.D.L., D.R.L., S.W.).'}, {'ForeName': 'Khaldoun G', 'Initials': 'KG', 'LastName': 'Tarakji', 'Affiliation': 'Department of Cardiovascular Medicine and Heart and Vascular Institute, Cleveland Clinic, OH (B.L.W., K.G.T.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.119.008280']
1770,22383802,A pilot test of a tailored mobile and web-based diabetes messaging system for adolescents.,"We conducted a pilot trial of a new mobile and web-based intervention to improve diabetes adherence. The text messaging system was designed to motivate and remind adolescents about diabetes self-care tasks. Text messages were tailored according to individually-reported barriers to diabetes self-care. A total of 23 adolescents with type 1 diabetes used the system for a period of three months. On average, they received 10 text messages per week (range 8-12). A matched historical control group from the same clinic was used for comparison. After three months, system users rated the content, usability and experiences with the system, which were very favourable. Comparison of the intervention and control groups indicated a significant interaction between group and time. Both groups had similar HbA(1c) levels at baseline. After three months, the mean HbA(1c) level in the intervention group was unchanged (8.8%), but the mean level in the control group was significantly higher (9.9%), P = 0.006. The results demonstrate the feasibility of the messaging system, user acceptance and a promising effect on glycaemic control. Integrating this type of messaging system with online educational programming could prove to be beneficial.",2012,"After three months, the mean HbA(1c) level in the intervention group was unchanged (8.8%), but the mean level in the control group was significantly higher (9.9%), P = 0.006.","['adolescents', '23 adolescents with type 1 diabetes']","['tailored mobile and web-based diabetes messaging system', 'new mobile and web-based intervention']","['similar HbA(1c) levels', 'mean HbA(1c) level', 'mean level', 'diabetes adherence']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}]","[{'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",23.0,0.0287522,"After three months, the mean HbA(1c) level in the intervention group was unchanged (8.8%), but the mean level in the control group was significantly higher (9.9%), P = 0.006.","[{'ForeName': 'Shelagh A', 'Initials': 'SA', 'LastName': 'Mulvaney', 'Affiliation': 'School of Nursing, Vanderbilt University Medical Center, 461 21st Avenue South, Nashville, TN 37240, USA. helagh.mulvaney@vanderbilt.edu'}, {'ForeName': 'Shilo', 'Initials': 'S', 'LastName': 'Anders', 'Affiliation': ''}, {'ForeName': 'Annie K', 'Initials': 'AK', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Pittel', 'Affiliation': ''}, {'ForeName': 'Kevin B', 'Initials': 'KB', 'LastName': 'Johnson', 'Affiliation': ''}]",Journal of telemedicine and telecare,['10.1258/jtt.2011.111006']
1771,22085803,Design and methodological considerations of an effectiveness trial of a computer-assisted intervention: an example from the NIDA Clinical Trials Network.,"Computer-assisted interventions hold the promise of minimizing two problems that are ubiquitous in substance abuse treatment: the lack of ready access to treatment and the challenges to providing empirically-supported treatments. Reviews of research on computer-assisted treatments for mental health and substance abuse report promising findings, but study quality and methodological limitations remain an issue. In addition, relatively few computer-assisted treatments have been tested among illicit substance users. This manuscript describes the methodological considerations of a multi-site effectiveness trial conducted within the National Institute on Drug Abuse's (NIDA's) National Drug Abuse Treatment Clinical Trials Network (CTN). The study is evaluating a web-based version of the Community Reinforcement Approach, in addition to prize-based contingency management, among 500 participants enrolled in 10 outpatient substance abuse treatment programs. Several potential effectiveness trial designs were considered and the rationale for the choice of design in this study is described. The study uses a randomized controlled design (with independent treatment arm allocation), intention-to-treat primary outcome analysis, biological markers for the primary outcome of abstinence, long-term follow-up assessments, precise measurement of intervention dose, and a cost-effectiveness analysis. Input from community providers during protocol development highlighted potential concerns and helped to address issues of practicality and feasibility. Collaboration between providers and investigators supports the utility of infrastructures that enhance research partnerships to facilitate effectiveness trials and dissemination of promising, technologically innovative treatments. Outcomes from this study will further the empirical knowledge base on the effectiveness and cost-effectiveness of computer-assisted treatment in clinical treatment settings.",2012,Computer-assisted interventions hold the promise of minimizing two problems that are ubiquitous in substance abuse treatment: the lack of ready access to treatment and the challenges to providing empirically-supported treatments.,['500 participants enrolled in 10 outpatient substance abuse treatment programs'],['computer-assisted intervention'],['effectiveness and cost-effectiveness'],"[{'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0740858', 'cui_str': 'Substance Abuse'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",500.0,0.0825457,Computer-assisted interventions hold the promise of minimizing two problems that are ubiquitous in substance abuse treatment: the lack of ready access to treatment and the challenges to providing empirically-supported treatments.,"[{'ForeName': 'Aimee N C', 'Initials': 'AN', 'LastName': 'Campbell', 'Affiliation': 'New York State Psychiatric Institute, Department of Psychiatry, Columbia University College of Physicians and Surgeons, 1051 Riverside Drive, New York, NY 10032, United States. anc2002@columbia.edu'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': ''}, {'ForeName': 'Gloria M', 'Initials': 'GM', 'LastName': 'Miele', 'Affiliation': ''}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Matthews', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Polsky', 'Affiliation': ''}, {'ForeName': 'Udi E', 'Initials': 'UE', 'LastName': 'Ghitza', 'Affiliation': ''}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Turrigiano', 'Affiliation': ''}, {'ForeName': 'Genie L', 'Initials': 'GL', 'LastName': 'Bailey', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'VanVeldhuisen', 'Affiliation': ''}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Chapdelaine', 'Affiliation': ''}, {'ForeName': 'Autumn', 'Initials': 'A', 'LastName': 'Froias', 'Affiliation': ''}, {'ForeName': 'Maxine L', 'Initials': 'ML', 'LastName': 'Stitzer', 'Affiliation': ''}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Carroll', 'Affiliation': ''}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': ''}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Clingerman', 'Affiliation': ''}, {'ForeName': 'Livangelie', 'Initials': 'L', 'LastName': 'Perez', 'Affiliation': ''}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'McClure', 'Affiliation': ''}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Goldman', 'Affiliation': ''}, {'ForeName': 'A Rebecca', 'Initials': 'AR', 'LastName': 'Crowell', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2011.11.001']
1772,32422066,Effect of Acupuncture for Postprandial Distress Syndrome: A Randomized Clinical Trial.,"BACKGROUND


Postprandial distress syndrome (PDS) is the most common subtype of functional dyspepsia. Acupuncture is commonly used to treat PDS, but its effect is uncertain because of the poor quality of prior studies.
OBJECTIVE


To assess the efficacy of acupuncture versus sham acupuncture in patients with PDS.
DESIGN


Multicenter, 2-group, randomized clinical trial. (ISRCTN registry number: ISRCTN12511434).
SETTING


5 tertiary hospitals in China.
PARTICIPANTS


Chinese patients aged 18 to 65 years meeting Rome IV criteria for PDS.
INTERVENTION


12 sessions of acupuncture or sham acupuncture over 4 weeks.
MEASUREMENTS


The 2 primary outcomes were the response rate based on overall treatment effect and the elimination rate of all 3 cardinal symptoms: postprandial fullness, upper abdominal bloating, and early satiation after 4 weeks of treatment. Participants were followed until week 16.
RESULTS


Among the 278 randomly assigned participants, 228 (82%) completed outcome measurements at week 16. The estimated response rate from generalized linear mixed models at week 4 was 83.0% in the acupuncture group versus 51.6% in the sham acupuncture group (difference, 31.4 percentage points [95% CI, 20.3 to 42.5 percentage points];  P  < 0.001). The estimated elimination rate of all 3 cardinal symptoms was 27.8% in the acupuncture group versus 17.3% in the sham acupuncture group (difference, 10.5 percentage points [CI, 0.08 to 20.9 percentage points];  P  = 0.034). The efficacy of acupuncture was maintained during the 12-week posttreatment follow-up. There were no serious adverse events.
LIMITATION


Lack of objective outcomes and daily measurement, high dropout rate, and inability to blind acupuncturists.
CONCLUSION


Among patients with PDS, acupuncture resulted in increased response rate and elimination rate of all 3 cardinal symptoms compared with sham acupuncture, with sustained efficacy over 12 weeks in patients who received thrice-weekly acupuncture for 4 weeks.
PRIMARY FUNDING SOURCE


Beijing Municipal Science and Technology Commission.",2020,"The estimated response rate from generalized linear mixed models at week 4 was 83.0% in the acupuncture group versus 51.6% in the sham acupuncture group (difference, 31.4 percentage points [95% CI, 20.3 to 42.5 percentage points];  ","['5 tertiary hospitals in China', 'Chinese patients aged 18 to 65 years meeting Rome IV criteria for PDS', 'patients with PDS', 'Postprandial Distress Syndrome', '278 randomly assigned participants, 228 (82%) completed outcome measurements at week 16']","['acupuncture', 'acupuncture versus sham acupuncture', 'acupuncture or sham acupuncture', 'Acupuncture', 'sham acupuncture']","['response rate based on overall treatment effect and the elimination rate of all 3 cardinal symptoms: postprandial fullness, upper abdominal bloating, and early satiation', 'elimination rate of all 3 cardinal symptoms', 'response rate and elimination rate']","[{'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0326926', 'cui_str': 'Cardinalis cardinalis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}]",278.0,0.617612,"The estimated response rate from generalized linear mixed models at week 4 was 83.0% in the acupuncture group versus 51.6% in the sham acupuncture group (difference, 31.4 percentage points [95% CI, 20.3 to 42.5 percentage points];  ","[{'ForeName': 'Jing-Wen', 'Initials': 'JW', 'LastName': 'Yang', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China (J.Y., L.W., X.Z., G.S.).'}, {'ForeName': 'Li-Qiong', 'Initials': 'LQ', 'LastName': 'Wang', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China (J.Y., L.W., X.Z., G.S.).'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Zou', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China (J.Y., L.W., X.Z., G.S.).'}, {'ForeName': 'Shi-Yan', 'Initials': 'SY', 'LastName': 'Yan', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China (S.Y.).'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing, China (Y.W., J.T.).'}, {'ForeName': 'Jing-Jie', 'Initials': 'JJ', 'LastName': 'Zhao', 'Affiliation': 'Beijing Friendship Hospital, Capital Medical University, Beijing, China (J.Z., Y.D.).'}, {'ForeName': 'Jian-Feng', 'Initials': 'JF', 'LastName': 'Tu', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing, China (Y.W., J.T.).'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China (J.W.).'}, {'ForeName': 'Guang-Xia', 'Initials': 'GX', 'LastName': 'Shi', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China (J.Y., L.W., X.Z., G.S.).'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China (H.H.).'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Huguosi Hospital of Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China (W.Z.).'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Beijing Friendship Hospital, Capital Medical University, Beijing, China (J.Z., Y.D.).'}, {'ForeName': 'Cun-Zhi', 'Initials': 'CZ', 'LastName': 'Liu', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, and Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing, China (C.L.).'}]",Annals of internal medicine,['10.7326/M19-2880']
1773,32423348,Associations Between Dietary Patterns and Subclinical Cardiac Injury: An Observational Analysis From the DASH Trial.,"BACKGROUND


The DASH diet has been found to lower blood pressure (BP) and low-density lipoprotein cholesterol levels.
OBJECTIVE


To compare diets rich in fruits and vegetables with a typical American diet in their effects on cardiovascular injury in middle-aged adults without known preexisting cardiovascular disease (CVD).
DESIGN


Observational study based on a 3-group, parallel-design, randomized trial conducted in the United States from 1994 to 1996. (ClinicalTrials.gov: NCT00000544).
SETTING


3 of the 4 original clinical trial centers.
PARTICIPANTS


326 of the original 459 trial participants with available stored specimens.
INTERVENTION


Participants were randomly assigned to 8 weeks of monitored feeding with a control diet typical of what many Americans eat; a diet rich in fruits and vegetables but otherwise similar to the control diet; or the DASH diet, which is rich in fruits, vegetables, low-fat dairy, and fiber and has low levels of saturated fat and cholesterol. Weight was kept constant throughout feeding.
MEASUREMENTS


Biomarkers collected at baseline and 8 weeks: high-sensitivity cardiac troponin I (hs-cTnI),  N -terminal pro-B-type natriuretic peptide (NT-proBNP), and high-sensitivity C-reactive protein (hs-CRP).
RESULTS


The mean age of participants was 45.2 years, 48% were women, 49% were black, and mean baseline BP was 131/85 mm Hg. Compared with the control diet, the fruit-and-vegetable diet reduced hs-cTnI levels by 0.5 ng/L (95% CI, -0.9 to -0.2 ng/L) and NT-proBNP levels by 0.3 pg/mL (CI, -0.5 to -0.1 pg/mL). Compared with the control diet, the DASH diet reduced hs-cTnI levels by 0.5 ng/L (CI, -0.9 to -0.1 ng/L) and NT-proBNP levels by 0.3 pg/mL (CI, -0.5 to -0.04 pg/mL). Levels of hs-CRP did not differ among diets. None of the markers differed between the fruit-and-vegetable and DASH diets.
LIMITATION


Short duration, missing specimens, and an inability to isolate the effects of specific foods or micronutrients.
CONCLUSION


Diets rich in fruits and vegetables given over 8 weeks were associated with lower levels of markers for subclinical cardiac damage and strain in adults without preexisting CVD.
PRIMARY FUNDING SOURCE


National Institutes of Health, National Heart, Lung, and Blood Institute.",2020,"Diets rich in fruits and vegetables given over 8 weeks were associated with lower levels of markers for subclinical cardiac damage and strain in adults without preexisting CVD.
","['middle-aged adults without known preexisting cardiovascular disease (CVD', '3 of the 4 original clinical trial centers', '326 of the original 459 trial participants with available stored specimens', 'United States from 1994 to 1996', 'The mean age of participants was 45.2 years, 48% were women, 49% were black, and mean baseline BP was 131/85 mm Hg', 'adults without preexisting CVD']","['diets rich in fruits and vegetables with a typical American diet', 'control diet typical of what many Americans eat; a diet rich in fruits and vegetables but otherwise similar to the control diet; or the DASH diet']","['blood pressure (BP) and low-density lipoprotein cholesterol levels', 'cardiovascular injury', 'NT-proBNP levels', 'hs-cTnI levels', 'Weight', 'Levels of hs-CRP', 'high-sensitivity cardiac troponin']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C0560570', 'cui_str': 'Cardiovascular injury'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0883409', 'cui_str': 'Cardiac troponin I'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}]",,0.0964925,"Diets rich in fruits and vegetables given over 8 weeks were associated with lower levels of markers for subclinical cardiac damage and strain in adults without preexisting CVD.
","[{'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts (S.P.J., K.J.M.).'}, {'ForeName': 'Lara C', 'Initials': 'LC', 'LastName': 'Kovell', 'Affiliation': 'University of Massachusetts Medical School, Worcester, Massachusetts (L.C.K.).'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'The Johns Hopkins University School of Medicine, The Johns Hopkins Bloomberg School of Public Health, and The Welch Center for Prevention, Epidemiology and Clinical Research, Baltimore, Maryland (L.J.A., E.R.M.).'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'The Johns Hopkins University School of Medicine, The Johns Hopkins Bloomberg School of Public Health, and The Welch Center for Prevention, Epidemiology and Clinical Research, Baltimore, Maryland (L.J.A., E.R.M.).'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Sacks', 'Affiliation': ""Harvard T.H. Chan School of Public Health, Harvard Medical School, Brigham and Women's Hospital, Boston, Massachusetts (F.M.S.).""}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Christenson', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, Maryland (R.H.C., H.R.).'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Rebuck', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, Maryland (R.H.C., H.R.).'}, {'ForeName': 'Alexander R', 'Initials': 'AR', 'LastName': 'Chang', 'Affiliation': 'Geisinger Health System, Danville, Pennsylvania (A.R.C.).'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Mukamal', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts (S.P.J., K.J.M.).'}]",Annals of internal medicine,['10.7326/M20-0336']
1774,22364776,"Attention-deficit/hyperactivity disorder (ADHD) symptoms, craving to smoke, and tobacco withdrawal symptoms in adult smokers with ADHD.","BACKGROUND


Tobacco withdrawal symptoms may be confounded with attention-deficit/hyperactivity disorder (ADHD) symptoms among smokers with ADHD.
OBJECTIVE


(1) To assess overlap between ADHD symptoms and tobacco/nicotine withdrawal symptoms and craving; (2) to assess the relationship between craving or withdrawal symptoms and the effect of osmotic-release oral system methylphenidate (OROS-MPH) on ADHD symptoms; (3) to assess the association of ADHD symptoms, craving, and withdrawal symptoms with abstinence.
METHODS


Secondary analysis of a randomized, placebo controlled smoking cessation trial assessing the efficacy of OROS-MPH taken in addition to nicotine patch among individuals with ADHD. ADHD symptoms, withdrawal symptoms, and craving were assessed at baseline and 2, 4 and 6 weeks after a target quit day.
RESULTS


Withdrawal symptoms and craving showed limited and modest overlap with ADHD symptoms prior to abstinence but more extensive and stronger correlation after quit day. Compared to placebo, OROS-MPH reduced ADHD symptoms; this effect was attenuated by controlling for withdrawal symptoms, but not by craving. Craving, but not ADHD symptoms and withdrawal symptoms, was associated with abstinence during the trial.
CONCLUSION


When treating smokers with ADHD (1) craving, rather than tobacco withdrawal symptoms or ADHD symptoms may be the more effective therapeutic smoking cessation targets; (2) careful distinction of craving, withdrawal symptoms, and ADHD symptoms when assessing withdrawal phenomena is needed.",2012,"Compared to placebo, OROS-MPH reduced ADHD symptoms; this effect was attenuated by controlling for withdrawal symptoms, but not by craving.","['smokers with ADHD', 'individuals with ADHD', 'adult smokers with ADHD', 'smokers with ADHD (1) craving, rather than tobacco withdrawal symptoms or ADHD symptoms']","['OROS-MPH', 'nicotine patch', 'placebo', 'osmotic-release oral system methylphenidate (OROS-MPH']","['ADHD symptoms, withdrawal symptoms, and craving', 'OROS-MPH reduced ADHD symptoms', 'ADHD symptoms and withdrawal symptoms', 'ADHD symptoms, craving, and withdrawal symptoms with abstinence', 'ADHD) symptoms, craving to smoke, and tobacco withdrawal symptoms']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C1167842', 'cui_str': 'Tobacco withdrawal symptoms'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}]","[{'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal Symptoms'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C1167842', 'cui_str': 'Tobacco withdrawal symptoms'}]",,0.118462,"Compared to placebo, OROS-MPH reduced ADHD symptoms; this effect was attenuated by controlling for withdrawal symptoms, but not by craving.","[{'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Berlin', 'Affiliation': ""Département de Pharmacologie, Hôpital Pitié-Salpêtrière, AP-HP, Faculté de médicine, Université P. & M. Curie--INSERM U894, 47, bd de l'Hôpital, 75013 Paris, France. ivan.berlin@psl.aphp.fr""}, {'ForeName': 'Mei-Chen', 'Initials': 'MC', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Lirio S', 'Initials': 'LS', 'LastName': 'Covey', 'Affiliation': ''}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': ''}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2012.01.019']
1775,22209655,Injection behaviors among injection drug users in treatment: the role of hepatitis C awareness.,"BACKGROUND


Injection drug use (IDU) is a primary vector for blood-borne infections. Awareness of Hepatitis C virus (HCV) infection status may affect risky injection behaviors. This study determines the prevalence of risky injection practices and examines associations between awareness of positive HCV status and risky injection behaviors.
METHODS


We surveyed individuals seeking treatment for substance use at 12 community treatment programs as part of a national HIV screening trial conducted within the National Drug Abuse Treatment Clinical Trials Network. Participants reported socio-demographic characteristics, substance use, risk behaviors, and HCV status. We used multivariable logistic regression to test associations between participant characteristics and syringe/needle sharing.
RESULTS


The 1281 participants included 244 (19.0%) individuals who reported injecting drugs in the past 6 months and 37.7% of IDUs reported being HCV positive. During the six months preceding baseline assessment, the majority of IDUs reported obtaining sterile syringes from pharmacies (51.6%) or syringe exchange programs (25.0%), but fewer than half of IDUs always used a sterile syringe (46.9%). More than one-third (38.5%) shared syringe/needles with another injector in the past 6 months. Awareness of positive HCV vs. negative/unknown status was associated with increased recent syringe/needle sharing (aOR 2.37, 95% CI 1.15, 4.88) in multivariable analysis.
CONCLUSIONS


Risky injection behaviors remain prevalent and awareness of HCV infection was associated with increased risky injection behaviors. New approaches are needed to broadly implement HCV prevention interventions for IDUs seeking addiction treatment.",2012,"Awareness of positive HCV vs. negative/unknown status was associated with increased recent syringe/needle sharing (aOR 2.37, 95% CI 1.15, 4.88) in multivariable analysis.
","['We surveyed individuals seeking treatment for substance use at 12 community treatment programs as part of a national HIV screening trial conducted within the National Drug Abuse Treatment Clinical Trials Network', '1281 participants included 244 (19.0%) individuals who reported injecting drugs in the past 6 months and 37.7% of IDUs reported being HCV positive']",[],"['risky injection behaviors', 'Injection behaviors', 'socio-demographic characteristics, substance use, risk behaviors, and HCV status']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0013146', 'cui_str': 'Drug abuse (disorder)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517660', 'cui_str': 'Two hundred and forty-four'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",[],"[{'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",1281.0,0.065065,"Awareness of positive HCV vs. negative/unknown status was associated with increased recent syringe/needle sharing (aOR 2.37, 95% CI 1.15, 4.88) in multivariable analysis.
","[{'ForeName': 'P Todd', 'Initials': 'PT', 'LastName': 'Korthuis', 'Affiliation': 'Department of Medicine and Department of Public Health and Preventive Medicine, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA. korthuis@ohsu.edu'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Feaster', 'Affiliation': ''}, {'ForeName': 'Zoilyn L', 'Initials': 'ZL', 'LastName': 'Gomez', 'Affiliation': ''}, {'ForeName': 'Moupali', 'Initials': 'M', 'LastName': 'Das', 'Affiliation': ''}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Tross', 'Affiliation': ''}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Wiest', 'Affiliation': ''}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Douaihy', 'Affiliation': ''}, {'ForeName': 'Raul N', 'Initials': 'RN', 'LastName': 'Mandler', 'Affiliation': ''}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Sorensen', 'Affiliation': ''}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Colfax', 'Affiliation': ''}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'McCarty', 'Affiliation': ''}, {'ForeName': 'Stephanie E', 'Initials': 'SE', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Patricia E', 'Initials': 'PE', 'LastName': 'Penn', 'Affiliation': ''}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Lape', 'Affiliation': ''}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Metsch', 'Affiliation': ''}]",Addictive behaviors,['10.1016/j.addbeh.2011.12.001']
1776,31502498,Behavioral Recovery and Early Decision Making in Patients with Prolonged Disturbance in Consciousness after Traumatic Brain Injury.,"The extent of behavioral recovery that occurs in patients with traumatic disorders of consciousness (DoC) following discharge from the acute care setting has been under-studied and increases the risk of overly pessimistic outcome prediction. The aim of this observational cohort study was to systematically track behavioral and functional recovery in patients with prolonged traumatic DoC following discharge from the acute care setting. Standardized behavioral data were acquired from 95 patients in a minimally conscious (MCS) or vegetative state (VS) recruited from 11 clinic sites and randomly assigned to the placebo arm of a previously completed prospective clinical trial. Patients were followed for 6 weeks by blinded observers to determine frequency of recovery of six target behaviors associated with functional status. The Coma Recovery Scale-Revised and Disability Rating Scale were used to track reemergence of target behaviors and assess degree of functional disability, respectively. Twenty percent (95% confidence interval [CI]: 13-30%) of participants (mean age 37.2; median 47 days post-injury; 69 men) recovered all six target behaviors within the 6 week observation period. The odds of recovering a specific target behavior were 3.2 (95% CI: 1.2-8.1) to 7.8 (95% CI: 2.7-23.0) times higher for patients in MCS than for those in VS. Patients with preserved language function (""MCS+"") recovered the most behaviors ( p  ≤ 0.002) and had the least disability ( p  ≤ 0.002) at follow-up. These findings suggest that recovery of high-level behaviors underpinning functional independence is common in patients with prolonged traumatic DoC. Clinicians involved in early prognostic counseling should recognize that failure to emerge from traumatic DoC before 28 days does not necessarily portend unfavorable outcome.",2020,"(""MCS+"") recovered the most behaviors (P≤.002) and had the least disability (P≤.002) at follow-up.","['patients with traumatic disorders of consciousness (DoC', 'Patients with Prolonged Disturbance in Consciousness after Traumatic Brain Injury', 'patients with prolonged traumatic DoC. Clinicians', '95 patients in a minimally conscious (MCS) or vegetative state (VS) recruited from 11 clinic sites and randomly assigned to the', 'Patients with preserved language function', 'patients with prolonged traumatic DoC following discharge from the acute care setting']",['placebo'],"['least disability', 'Coma Recovery Scale-Revised and Disability Rating Scale', 'odds of recovering a specific target behavior']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0011710', 'cui_str': 'desoxycortone'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0917808', 'cui_str': 'Vegetative State'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0009421', 'cui_str': 'Comatose'}, {'cui': 'C0222045'}, {'cui': 'C0451125', 'cui_str': 'Disability rating scale (assessment scale)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",69.0,0.375738,"(""MCS+"") recovered the most behaviors (P≤.002) and had the least disability (P≤.002) at follow-up.","[{'ForeName': 'Joseph T', 'Initials': 'JT', 'LastName': 'Giacino', 'Affiliation': 'Spaulding Rehabilitation Hospital, Charlestown, Massachusetts.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sherer', 'Affiliation': 'Methodist Rehabilitation Center, Jackson, Mississippi.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Christoforou', 'Affiliation': 'Spaulding Rehabilitation Hospital, Charlestown, Massachusetts.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Maurer-Karattup', 'Affiliation': 'SRH Fachkrankenhaus Neresheim, Neresheim, Germany.'}, {'ForeName': 'Flora M', 'Initials': 'FM', 'LastName': 'Hammond', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Carolinas Rehabilitation, Charlotte, North Carolina.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Long', 'Affiliation': 'Brain Injury Program, Bryn Mawr Rehab Hospital, Malvern, Pennsylvania.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Bagiella', 'Affiliation': 'Center for Biostatistics, Icahn School of Medicine at Mount Sinai, New York, New York.'}]",Journal of neurotrauma,['10.1089/neu.2019.6429']
1777,32423331,Glutamate levels and perfusion in pons during migraine attacks: A 3T MRI study using proton spectroscopy and arterial spin labeling.,"Migraine is a complex disorder, involving peripheral and central brain structures, where mechanisms and site of attack initiation are an unresolved puzzle. While abnormal pontine neuronal activation during migraine attacks has been reported, exact implication of this finding is unknown. Evidence suggests an important role of glutamate in migraine, implying a possible association of pontine hyperactivity to increased glutamate levels. Migraine without aura patients were scanned during attacks after calcitonin gene-related peptide and sildenafil in a double-blind, randomized, double-dummy, cross-over design, on two separate study days, by proton magnetic resonance spectroscopy and pseudo-continuous arterial spin labeling at 3T. Headache characteristics were recorded until 24 h after drug administrations. Twenty-six patients were scanned during migraine, yielding a total of 41 attacks. Cerebral blood flow increased in dorsolateral pons, ipsilateral to pain side during attacks, compared to outside attacks (13.6%, p = 0.009). Glutamate levels in the same area remained unchanged during attacks (p = 0.873), while total creatine levels increased (3.5%, p = 0.041). In conclusion, dorsolateral pontine activation during migraine was not associated with higher glutamate levels. However, the concurrently increased total creatine levels may suggest an altered energy metabolism, which should be investigated in future studies to elucidate the role of pons in acute migraine.",2020,"Glutamate levels in the same area remained unchanged during attacks (p = 0.873), while total creatine levels increased (3.5%, p = 0.041).","['Twenty-six patients were scanned during migraine, yielding a total of 41 attacks', 'pons during migraine attacks']","['calcitonin gene-related peptide and sildenafil', 'Migraine', 'proton spectroscopy and arterial spin labeling']","['Cerebral blood flow', 'total creatine levels', 'Glutamate levels']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0032639', 'cui_str': 'Pontine structure'}]","[{'cui': 'C0006669', 'cui_str': 'Calcitonin gene-related peptide'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0037812', 'cui_str': 'Analysis, Spectrum'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}]","[{'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}]",26.0,0.178407,"Glutamate levels in the same area remained unchanged during attacks (p = 0.873), while total creatine levels increased (3.5%, p = 0.041).","[{'ForeName': 'Samaira', 'Initials': 'S', 'LastName': 'Younis', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Casper E', 'Initials': 'CE', 'LastName': 'Christensen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Vestergaard', 'Affiliation': 'Functional Imaging Unit, Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Lindberg', 'Affiliation': 'Functional Imaging Unit, Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Tolnai', 'Affiliation': 'Department of Radiology, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Olaf B', 'Initials': 'OB', 'LastName': 'Paulson', 'Affiliation': 'Neurobiology Research Unit, Department of Neurology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Henrik Bw', 'Initials': 'HB', 'LastName': 'Larsson', 'Affiliation': 'Functional Imaging Unit, Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Hougaard', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Glostrup, Denmark.'}]",Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism,['10.1177/0271678X20906902']
1778,22229134,A comparison between two different alveolar recruitment maneuvers in patients with acute respiratory distress syndrome.,"BACKGROUND


Alveolar recruitment is a physiological process that denotes the reopening of previously gasless lung units exposed to positive pressure ventilation. The current study was aimed to compare two recruitment maneuvers, a high continuous positive airway pressure (CPAP), and an extended sigh in patients with ARDS.
MATERIALS AND METHODS


Forty patients with acute respiratory distress syndrome were randomly divided into two groups, 20 patients each. Group I received a CPAP of 40 cm H(2)O for 40 seconds and group II received extended sigh (providing a sufficient recruiting pressure × time). In our study, we assessed the effects of both recruitment maneuvers on respiratory mechanics, gas exchange, and hemodynamics. These data were analyzed using two-way analysis of variance (ANOVA) followed by a Student--Newman--Keuls post hoc comparison test. P < 0.05 was considered statistically significant.
RESULTS


Both methods improved the compliance, increased arterial oxygenation (PaO(2)), increased the PaO(2)/FiO(2) ratio, and reduced the pulmonary shunt fraction (Q(s)/Q(t)). However, the extended sigh improved both PaO(2) and PaO(2)/FiO(2) ratios more than continuous positive airway pressure. Also the hemodynamic parameters were better maintained during the extended sigh.
CONCLUSION


Alveolar recruitment maneuvers are effective in management of mechanically ventilated ARDS patients. We conclude that extended sigh is more effective than continuous positive airway pressure as a recruitment maneuver.",2011,"Both methods improved the compliance, increased arterial oxygenation (PaO(2)), increased the PaO(2)/FiO(2) ratio, and reduced the pulmonary shunt fraction (Q(s)/Q(t)).","['patients with ARDS', 'patients with acute respiratory distress syndrome', 'Forty patients with acute respiratory distress syndrome', 'mechanically ventilated ARDS patients']",['CPAP of 40 cm H(2)O for 40 seconds and group II received extended sigh (providing a sufficient recruiting pressure × time'],"['PaO(2) and PaO(2)/FiO(2) ratios', 'compliance, increased arterial oxygenation (PaO(2)), increased the PaO(2)/FiO(2) ratio, and reduced the pulmonary shunt fraction (Q(s)/Q(t', 'respiratory mechanics, gas exchange, and hemodynamics']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205410', 'cui_str': 'Sufficient (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C1442858', 'cui_str': 'Surgical fistula'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}]",40.0,0.0622876,"Both methods improved the compliance, increased arterial oxygenation (PaO(2)), increased the PaO(2)/FiO(2) ratio, and reduced the pulmonary shunt fraction (Q(s)/Q(t)).","[{'ForeName': 'Khaled M', 'Initials': 'KM', 'LastName': 'Mahmoud', 'Affiliation': 'Anesthesiology and ICU Department, Minoufiya Faculty of Medicine, Egypt.'}, {'ForeName': 'Amany S', 'Initials': 'AS', 'LastName': 'Ammar', 'Affiliation': ''}]",International journal of critical illness and injury science,['10.4103/2229-5151.84795']
1779,31537908,"Multicenter, randomised, open-label, non-comparative phase 2 trial on the efficacy and safety of the combination of bevacizumab and trabectedin with or without carboplatin in women with partially platinum-sensitive recurrent ovarian cancer.","BACKGROUND


Trabectedin, in addition to its antiproliferative effect, can modify the tumour microenvironment and this could be synergistic with bevacizumab. The efficacy and safety of trabectedin and bevacizumab ± carboplatin have never been investigated.
METHODS


In this phase 2 study, women progressing between 6 and 12 months since their last platinum-based therapy were randomised to Arm BT: bevacizumab, trabectedin every 21 days, or Arm BT+C: bevacizumab, trabectedin and carboplatin every 28 days, from cycles 1 to 6, then trabectedin and bevacizumab as in Arm BT. Primary endpoints were progression-free survival rate (PFS-6) and severe toxicity rate (ST-6) at 6 months, assuming a PFS-6 ≤35% for BT and ≤40% for BT+C as not of therapeutic interest and, for both arms, a ST-6  ≥ 30% as unacceptable.
RESULTS


BT+C (21 patients) did not meet the safety criteria for the second stage (ST-6 45%; 95%CI: 23%-69%) but PFS-6 was 85% (95%CI: 62%-97%). BT (50 patients) had 75% PFS-6 (95%CI: 60%-87%) and 16% ST-6 (95%CI 7%-30%).
CONCLUSIONS


BT compared favourably with other platinum- and non-platinum-based regimens. The combination with carboplatin needs to be assessed further in a re-modulated safer schedule to confirm its apparent strong activity.
CLINICAL TRIAL REGISTRATION


NCT01735071 (Clinicaltrials.gov).",2019,"BT (50 patients) had 75% PFS-6 (95%CI: 60%-87%) and 16% ST-6 (95%CI 7%-30%).
","['women with partially platinum-sensitive recurrent ovarian cancer', 'women progressing between 6 and 12 months since their last platinum-based therapy']","['BT: bevacizumab, trabectedin every 21 days, or Arm BT+C: bevacizumab, trabectedin and carboplatin', 'bevacizumab', 'trabectedin and bevacizumab', 'bevacizumab and trabectedin with or without carboplatin']","['efficacy and safety', 'progression-free survival rate (PFS-6) and severe toxicity rate (ST-6']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1311070', 'cui_str': 'trabectedin'}, {'cui': 'C3873150', 'cui_str': 'Every twenty one days (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.202843,"BT (50 patients) had 75% PFS-6 (95%CI: 60%-87%) and 16% ST-6 (95%CI 7%-30%).
","[{'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Colombo', 'Affiliation': 'Istituto Europeo di Oncologia, Milano, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Zaccarelli', 'Affiliation': 'Istituto Europeo di Oncologia, Milano, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Baldoni', 'Affiliation': 'Istituto Oncologico Veneto, IOV-IRCCS, Padova, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Frezzini', 'Affiliation': 'Istituto Oncologico Veneto, IOV-IRCCS, Padova, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica, Roma, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Palluzzi', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica, Roma, Italy.'}, {'ForeName': 'Germana', 'Initials': 'G', 'LastName': 'Tognon', 'Affiliation': 'UO Ostetricia e Ginecologia - ASST degli Spedali Civili di Brescia, Università degli Studi, Brescia, Italy.'}, {'ForeName': 'Andrea A', 'Initials': 'AA', 'LastName': 'Lissoni', 'Affiliation': 'Università di Milano-Bicocca, Clinica Ostetrica e Ginecologica, Milano, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Rubino', 'Affiliation': 'Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii, Bologna, Italy.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Ferrero', 'Affiliation': 'AO Ordine Mauriziano, SCDU Ginecologia ed Ostetricia, Torino, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Farina', 'Affiliation': 'ASST Fatebenefratelli Sacco, UOC di Oncologia, Milano, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Negri', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Pesenti Gritti', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Galli', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Biagioli', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Rulli', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Poli', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Gerardi', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Valter', 'Initials': 'V', 'LastName': 'Torri', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Roldano', 'Initials': 'R', 'LastName': 'Fossati', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy. roldano.fossati@marionegri.it.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': ""D'Incalci"", 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}]",British journal of cancer,['10.1038/s41416-019-0584-5']
1780,21322756,Abagovomab: an anti-idiotypic CA-125 targeted immunotherapeutic agent for ovarian cancer.,"Ovarian cancer remains the leading cause of death due to gynecologic malignancies. Most patients present with advanced disease at the time of diagnosis. Although many have a good initial response to surgical debulking and platinum-based chemotherapy, relapse is common, with the eventual development of chemotherapy resistance. Innovative treatments are needed in the remission setting to prolong the disease-free interval or prevent recurrence. Abagovomab is a murine monoclonal anti-idiotypic antibody (molecular weight: 165-175 kDa) that functionally imitates the tumor-associated antigen, CA-125. It has been shown to be well tolerated and to induce a sustained immune response in initial Phase I and II clinical trials. An ongoing, double-blind, placebo-controlled, multicenter, Phase III trial (MIMOSA) completed its double-blind period in December 2010 and will compare abagovomab maintenance therapy to placebo, which will definitively determine the efficacy of this immunotherapeutic approach in patients with ovarian cancer.",2011,It has been shown to be well tolerated and to induce a sustained immune response in initial Phase I and II clinical trials.,"['patients with ovarian cancer', 'ovarian cancer']","['Abagovomab', 'immunotherapeutic approach', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}]","[{'cui': 'C1832044', 'cui_str': 'abagovomab'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.205655,It has been shown to be well tolerated and to induce a sustained immune response in initial Phase I and II clinical trials.,"[{'ForeName': 'Rachel N', 'Initials': 'RN', 'LastName': 'Grisham', 'Affiliation': 'Department of Medicine, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY 10065, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Berek', 'Affiliation': ''}, {'ForeName': 'Jacobus', 'Initials': 'J', 'LastName': 'Pfisterer', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sabbatini', 'Affiliation': ''}]",Immunotherapy,['10.2217/imt.10.100']
1781,32037653,"Cardiovascular and kidney outcomes of linagliptin treatment in older people with type 2 diabetes and established cardiovascular disease and/or kidney disease: A prespecified subgroup analysis of the randomized, placebo-controlled CARMELINA® trial.","AIMS


In CARMELINA®, linagliptin demonstrated cardiovascular and renal safety in patients with type 2 diabetes (T2D) with high renal and cardiovascular disease (CVD) risk. We investigated safety and efficacy of this dipeptidyl peptidase-4 inhibitor in older participants.
MATERIALS AND METHODS


Subjects aged ≥18 years with T2D and established CVD with urinary albumin-to-creatinine ratio (UACR) >30 mg/g, and/or prevalent kidney disease, were randomized to linagliptin or placebo added to usual care. The primary endpoint (time to first occurrence of 3P-MACE: cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) and other outcomes were evaluated across age groups <65 (n = 2968), 65 to <75 (n = 2800) and ≥75 years (n = 1211).
RESULTS


Mean age was 65.9 years (17.4% and 5.9% aged ≥75 and 80, respectively) and median follow-up was 2.2 years. The hazard ratio (HR) for 3P-MACE with linagliptin versus placebo was 1.02 [95% confidence interval (CI) 0.89, 1.17] with no significant interaction between age and treatment effect (P = 0.0937). HRs for participants aged <65, 65 to <75 and ≥75 years were 1.11 (95% CI 0.89, 1.40), 1.09 (0.89, 1.33) and 0.76 (0.57, 1.02), respectively. Linagliptin did not increase the risk of adverse kidney outcomes or hospitalization for heart failure across age groups. The incidence of adverse events, including hypoglycaemia, increased with age but was similar with linagliptin and placebo despite glycated haemoglobin A1c reduction with linagliptin.
CONCLUSIONS


Linagliptin did not increase risk for cardiovascular events or hypoglycaemia and kidney function remained stable in older people with T2D and established CVD with albuminuria and/or kidney disease.",2020,"CONCLUSIONS


Linagliptin did not increase risk for cardiovascular events or hypoglycaemia and kidney function remained stable in older people with T2D and established CVD with albuminuria, and/or kidney disease.","['older people with T2D and established CVD with albuminuria, and/or kidney disease', 'type 2 diabetic (T2D) patients with high renal and cardiovascular disease (CVD) risk', 'and/or prevalent kidney disease', 'Subjects aged ≥18\u2009years with T2D and established CVD with urinary albumin-to-creatinine ratio (UACR) ', 'older participants', 'older people with type 2 diabetes and established cardiovascular disease and/or kidney disease', 'Mean age was 65.9\u2009years (17.4% and 5.9% aged ≥75 and 80, respectively) and median follow-up 2.2\u2009years']","['®, linagliptin', 'linagliptin', 'placebo', 'linagliptin or placebo', 'Linagliptin', 'dipeptidyl peptidase-4 inhibitor']","['hazard ratio (HR', 'incidence of adverse events including hypoglycaemia', 'primary endpoint (time to first occurrence of 3P-MACE: cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke', 'risk of adverse kidney outcomes or hospitalization for heart failure', 'Cardiovascular and kidney outcomes', 'safety and efficacy', 'cardiovascular events or hypoglycaemia and kidney function', 'cardiovascular and renal safety']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4517629', 'cui_str': '2.2'}]","[{'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl-Peptidase 4 Inhibitors'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.350486,"CONCLUSIONS


Linagliptin did not increase risk for cardiovascular events or hypoglycaemia and kidney function remained stable in older people with T2D and established CVD with albuminuria, and/or kidney disease.","[{'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Cooper', 'Affiliation': 'Department of Diabetes, Central Clinical School, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center at Medical City, Dallas, Texas.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kadowaki', 'Affiliation': 'Department of Prevention of Diabetes and Lifestyle-related Diseases, Graduate School of Medicine, University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Seino', 'Affiliation': 'Kansai Electric Power Medical Research Institute, Osaka, Japan.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Division of Nephrology, Department of Medicine, Würzburg University Clinic, Würzburg, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Schnaidt', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Clark', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Odd Erik', 'Initials': 'OE', 'LastName': 'Johansen', 'Affiliation': 'Boehringer Ingelheim Norway KS, Asker, Norway.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Diabetes, obesity & metabolism",['10.1111/dom.13995']
1782,32423937,"Effectiveness and acceptability of metformin in preventing the onset of type 2 diabetes after gestational diabetes in postnatal women: a protocol for a randomised, placebo-controlled, double-blind feasibility trial—Optimising health outcomes with Metformin to prevent diAbetes After pregnancy (OMAhA).","INTRODUCTION


Up to half of all women diagnosed with gestational diabetes mellitus develop type 2 diabetes within 5 years after delivery. Metformin is effective in preventing type 2 diabetes in high-risk non-pregnant individuals, but its effect when commenced in the postnatal period is not known. We plan to assess the feasibility of evaluating metformin versus placebo in minimising the risk of dysglycaemia including type 2 diabetes after delivery in postnatal women with a history of gestational diabetes through a randomised trial.
METHODS AND ANALYSIS


Optimising health outcomes with Metformin to prevent diAbetes After pregnancy (OMAhA) is a multicentre placebo-controlled double-blind randomised feasibility trial, where we will randomly allocate 160 postnatal women with gestational diabetes treated with medication to either metformin (intervention) or placebo (control) tablets to be taken until 1 year after delivery. The primary outcomes are rates of recruitment, randomisation, adherence and attrition. The secondary outcomes are maternal dysglycaemia, cost and quality of life outcomes in both arms, and acceptability of the study and intervention, which will be evaluated through a nested qualitative study. Feasibility outcomes will be summarised using descriptive statistics, point estimates and 95% CIs.
ETHICS AND DISSEMINATION


The OMAhA study received ethics approval from the London-Brent Research Ethics Committee (18/LO/0505). Trial findings will be published in a peer-reviewed journal, disseminated at conferences, through our Patient and Public Involvement advisory group (Katie's Team) and through social media platforms.
TRIAL REGISTRATION NUMBER


ISRCTN20930880.",2020,"The secondary outcomes are maternal dysglycaemia, cost and quality of life outcomes in both arms, and acceptability of the study and intervention, which will be evaluated through a nested qualitative study.","['women diagnosed with gestational diabetes mellitus develop type 2 diabetes within 5\u2009years after delivery', 'type 2 diabetes after gestational diabetes in postnatal women', '160 postnatal women with gestational diabetes treated with medication to either', 'diAbetes After pregnancy (OMAhA', 'to prevent diAbetes After pregnancy', 'postnatal women with a history of gestational diabetes']","['Metformin', 'metformin versus placebo', 'metformin', 'metformin (intervention) or placebo (control) tablets', 'placebo']","['maternal dysglycaemia, cost and quality of life outcomes in both arms, and acceptability of the study and intervention', 'rates of recruitment, randomisation, adherence and attrition', 'Effectiveness and acceptability']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",160.0,0.592804,"The secondary outcomes are maternal dysglycaemia, cost and quality of life outcomes in both arms, and acceptability of the study and intervention, which will be evaluated through a nested qualitative study.","[{'ForeName': 'Chiamaka Esther', 'Initials': 'CE', 'LastName': 'Amaefule', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK c.e.amaefule@qmul.ac.uk.""}, {'ForeName': 'Angeliki', 'Initials': 'A', 'LastName': 'Bolou', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Drymoussi', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Francisco Jose', 'Initials': 'FJ', 'LastName': 'Gonzalez Carreras', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Maria Del Carmen', 'Initials': 'MDC', 'LastName': 'Pardo Llorente', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Lanz', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Dodds', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Sweeney', 'Affiliation': 'Institute for Health and Human Development, University of East London, London, UK.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Pizzo', 'Affiliation': 'Collaborations for Leadership in Applied Health Research and Care (CLAHRC) for North Thames London, Department of Applied Health Research, University College London, London, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': ""D'Amico"", 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Thomas', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Heighway', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Jahnavi', 'Initials': 'J', 'LastName': 'Daru', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Soha', 'Initials': 'S', 'LastName': 'Sobhy', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Robson', 'Affiliation': 'Clinical Effectiveness Group, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Sanghi', 'Affiliation': ""Women's Division, Royal London Hospital, Barts Health NHS Trust, London, UK.""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Zamora', 'Affiliation': 'Clinical Biostatistics Unit (IRYCIS) and CIBER Epidemiology and Public Health, Ramon y Cajal University Hospital, Madrid, Spain.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Harden', 'Affiliation': 'Institute for Health and Human Development, University of East London, London, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Hitman', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Khan', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Pérez', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Mohammed Sb', 'Initials': 'MS', 'LastName': 'Huda', 'Affiliation': 'Department of Diabetes and Metabolism, Barts Health NHS Trust, Royal London Hospital, London, UK.'}, {'ForeName': 'Shakila', 'Initials': 'S', 'LastName': 'Thangaratinam', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}]",BMJ open,['10.1136/bmjopen-2019-036198']
1783,31827903,The role of mentors in addressing issues of work-life integration in an academic research environment.,"Introduction


There is growing evidence for both the need to manage work-life conflict and the opportunity for mentors to advise their mentees on how to do this in an academic research environment.
Methods


A multiphase approach was used to develop and implement an evidence-informed training module to help mentors guide their mentees in issues of work-life conflict. Analysis of existing data from a randomized controlled trial (RCT) of a mentor training curriculum (n = 283 mentor/mentee dyads) informed the development of a work-life mentoring module which was incorporated into an established research mentor training curriculum and evaluated by faculty at a single academic medical center.
Results


Only 39% of mentors and 36% of mentees in the RCT indicated high satisfaction with the balance between their personal and professional lives. The majority (75%) of mentors and mentees were sharing personal information as part of the mentoring relationship which was significantly associated with mentees' ratings of the balance between their personal and professional lives. The effectiveness of the work-life module was assessed by 60 faculty mentors participating in a mentor training program at an academic medical center from 2013 to 2017. Among the respondents to the post-training survey, 82.5% indicated they were very/somewhat comfortable addressing work-life issues with their mentees as a result of the training, with significant improvements (p = 0.001) in self-assessments of mentoring skill in this domain.
Conclusions


Our findings indicate that a structured training approach can significantly improve mentors' self-reported skills in addressing work-life issues with their mentees.",2019,Our findings indicate that a structured training approach can significantly improve mentors' self-reported skills in addressing work-life issues with their mentees.,['60 faculty mentors participating in a mentor training program at an academic medical center from 2013 to 2017'],"['mentor training curriculum', 'RCT']",[],"[{'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}]","[{'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}]",[],283.0,0.0439062,Our findings indicate that a structured training approach can significantly improve mentors' self-reported skills in addressing work-life issues with their mentees.,"[{'ForeName': 'Dennis R', 'Initials': 'DR', 'LastName': 'Durbin', 'Affiliation': 'Department of Pediatrics, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Stephanie C', 'Initials': 'SC', 'LastName': 'House', 'Affiliation': 'Institute for Clinical and Translational Research, University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Emma A', 'Initials': 'EA', 'LastName': 'Meagher', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Jenna Griebel', 'Initials': 'JG', 'LastName': 'Rogers', 'Affiliation': 'Institute for Clinical and Translational Research, University of Wisconsin-Madison, Madison, WI, USA.'}]",Journal of clinical and translational science,['10.1017/cts.2019.408']
1784,32430272,Diagnostic efficacy of three suction techniques for endoscopic ultrasound-guided fine-needle biopsy of solid pancreatic lesions: protocol for a multicenter randomized cross-over clinical trial.,"BACKGROUND


How suction technique affects endoscopic ultrasound-guided tissue acquisition (EUS-TA) remains unclear. A standardized protocol is currently lacking, with most previous studies being restricted to EUS-guided fine-needle aspiration (EUS-FNA). The research related to EUS-guided fine-needle biopsy (EUS-FNB) is sparse.
AIMS


The aim of this study is to evaluate the diagnostic efficacy, cellularity, tissue acquisition, blood contamination and adverse event rate of three common suction techniques (standard suction, slow-pull, and wet suction) used for EUS-FNB of solid pancreatic masses.
METHODS


This is a multicenter single-blind randomized cross-over superiority trial. A total of 300 patients with suspected pancreatic malignancy will be enrolled from digestive endoscopic centers at five large tertiary hospitals in China. All three suction techniques will be performed on each patient using a 25G ProCore needle, with the sequence of suction techniques determined by randomization. Cytological and histological specimens obtained with each of the three techniques will be assessed independently. Outcomes among the three suction techniques will be compared.
DISCUSSION


To the best of our knowledge, this is the largest multicenter randomized cross-over trial designed to determine the optimal suction technique for the diagnosis of solid pancreatic masses. This study may contribute to standardizing the suction technique for EUS-FNB.",2020,"All three suction techniques will be performed on each patient using a 25G ProCore needle, with the sequence of suction techniques determined by randomization.",['300 patients with suspected pancreatic malignancy will be enrolled from digestive endoscopic centers at five large tertiary hospitals in China'],"['endoscopic ultrasound-guided fine-needle biopsy', 'three common suction techniques (standard suction, slow-pull, and wet suction']","['diagnostic efficacy, cellularity, tissue acquisition, blood contamination and adverse event rate', 'Diagnostic efficacy']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0012238', 'cui_str': 'Digestive system function'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0085846', 'cui_str': 'Fine needle biopsy'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}, {'cui': 'C0205381', 'cui_str': 'Wet'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",300.0,0.0776443,"All three suction techniques will be performed on each patient using a 25G ProCore needle, with the sequence of suction techniques determined by randomization.","[{'ForeName': 'Shi-Yu', 'Initials': 'SY', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Changhai Hospital, Second Military Medical University /Naval Medical University, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Department of Gastroenterology, Changhai Hospital, Second Military Medical University /Naval Medical University, Shanghai, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Department of Gastroenterology, Affiliated Hospital of Southwest Medical University, Southwest Medical University, Luzhou, Sichuan Province, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Ding', 'Affiliation': 'Department of Gastroenterology, Wuhan Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei Province, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': ""Department of Gastroenterology, Shenzhen People's Hospital, Second Clinical Medical Sciences of Jinan University, Shenzhen, Guangdong Province, China.""}, {'ForeName': 'Yue-Ping', 'Initials': 'YP', 'LastName': 'Jiang', 'Affiliation': 'Department of Gastroenterology, Affiliated Hospital of Qingdao University, Medical College of Qingdao University, Qingdao, Shandong Province, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Department of Pathology, Changhai Hospital, Second Military Medical University /Naval Medical University, Shanghai, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Pathology, Changhai Hospital, Second Military Medical University /Naval Medical University, Shanghai, China.'}, {'ForeName': 'Zhen-Dong', 'Initials': 'ZD', 'LastName': 'Jin', 'Affiliation': 'Department of Gastroenterology, Changhai Hospital, Second Military Medical University /Naval Medical University, Shanghai, China. Electronic address: zhendjin@126.com.'}, {'ForeName': 'Kai-Xuan', 'Initials': 'KX', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Changhai Hospital, Second Military Medical University /Naval Medical University, Shanghai, China. Electronic address: wangkaixuan224007@163.com.'}]",Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver,['10.1016/j.dld.2020.03.026']
1785,31533605,"Synergism Effects of Ursolic Acid Supplementation on the Levels of Irisin, C-reactive Protein, IL-6, and TNF-α During High-intensity Resistance Training in Low Activity Men.","BACKGROUND


Ursolic Acid (UA) is a pentacyclic triterpenoid carboxylic acid which is extracted from plants. UA may enhance the effect of Resistance Training (RT) in human.
OBJECTIVE


Current research was designed to show the effect of High-Intensity Resistance Training (HIRT) in the presence or absence of UA on the serum levels of irisin, CRP, IL-6 and TNF-α in the low activity men.
METHODS


The study included twenty-two healthy male HIRT with placebo, supplementation, and HIRT in the presence of UA supplementation. The two groups received eight-week intervention including 2 sets of 8 exercises, with 8~10 repetitions at 70~75% of 1 repetition maximum and a 2 min rest interval between sets, performed 3 times/week. Placebo or UA orally was evaluated as 1 capsule 3 times/day during 8 weeks. The subsequent factors were measured post- and preintervention: C-Reactive Protein (CRP), Irisin, Tumor Necrotic Factor (TNF-α) and Interleukin-6 (IL-6).
RESULTS


UA supplementation significantly increased the plasma levels of irisin in the HIRT+UA group versus the HIRT+P group (p<0.05). UA treatment also dramatically decreased the plasma levels of CRP, IL-6, and TNF-α in the HIRT+UA group versus the HIRT+P group (p<0.05).
CONCLUSION


The current data showed that UA-induced an increase in serum irisin and reduction of CRP, IL-6, and TNF-α may have beneficial effects as a chemical for increasing of the effects of HIRT in low activity men.",2020,"UA treatment also dramatically decreased the plasma levels of CRP, IL-6, and TNF-α in the HIRT+UA group versus the HIRT+P group (p<0.05).
","['low activity men', 'Twenty-two healthy male HIRT with placebo, supplementation, and HIRT in presence of UA supplementation']","['Placebo', 'HIRT+P', 'ursolic acid supplementation', 'high-intensity resistance training (HIRT']","['levels of irisin, C-reactive protein, IL-6, and TNF-α', 'reactive protein (CRP), irisin, tumor necrotic factor (TNF-α) and interleukin-6 (IL-6', 'plasma levels of CRP, IL-6, and TNF-α', 'serum irisin and reduction of CRP, IL-6, and TNF-α', 'serum levels of irisin, CRP, IL-6, and TNF-α', 'plasma levels of irisin']","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0077938', 'cui_str': 'ursolic acid'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",22.0,0.0467723,"UA treatment also dramatically decreased the plasma levels of CRP, IL-6, and TNF-α in the HIRT+UA group versus the HIRT+P group (p<0.05).
","[{'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Asghari', 'Affiliation': 'Department of Physical Education and Sport Sciences, Faculty of Sport Science, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Rashidlamir', 'Affiliation': 'Department of Physical Education and Sport Sciences, Faculty of Sport Science, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Seyyed R A', 'Initials': 'SRA', 'LastName': 'Hosseini', 'Affiliation': 'Department of Physical Education and Sport Sciences, Faculty of Sport Science, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Moazzami', 'Affiliation': 'Department of Physical Education and Sport Sciences, Faculty of Sport Science, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Samarghandian', 'Affiliation': 'Department of Basic Medical Sciences, Neyshabur University of Medical Sciences, Neyshabur, Iran.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Farkhondeh', 'Affiliation': 'Cardiovascular Diseases Research Center, Birjand University of Medical Sciences, Birjand, Iran.'}]",Cardiovascular & hematological disorders drug targets,['10.2174/1871529X19666190918144727']
1786,31604496,A Prospective Randomized Trial Comparing Suture Bridge and Medially Based Single-Row Rotator Cuff Repair in Medium-Sized Supraspinatus Tears.,"PURPOSE


To compare the clinical and imaging outcomes between the suture bridge technique (SB) and the medially based single-row technique (medSR) in patients with 1- to 3-cm tear sizes.
METHODS


All patients were evaluated preoperatively and postoperatively (at 12 and 24 months) using the modified University of California, Los Angeles scoring system; active range of motion (flexion and external rotation); and a visual analog scale for pain. Healing status was examined by postoperative magnetic resonance imaging.
RESULTS


Clinical and imaging evaluations were completed by 92 patients at 1-year follow-up and by 74 patients at 2 years. No significant differences were found between the 2 groups across all measures at final follow-up: The University of California, Los Angeles scores were 33.4 points in SB patients and 33.0 points in medSR patients (P = .58); the visual analog scale scores were 6 mm and 7 mm, respectively (P = .38); the active flexion angles were 161° and 159°, respectively (P = .34); and the external rotation angles were 49° and 52°, respectively (P = .37). Retears were observed in 6.5% of SB patients and 2.1% of medSR patients (P = .31). Medial cuff failure was observed only in SB patients (4.3%, 2 cases), whereas incomplete healing (deep-layer retraction pattern) was observed only in medSR patients (8.7%, 4 cases). Neo-tendon regeneration in the medSR group was observed in 93% of patients.
CONCLUSIONS


This study did not show any significant differences in the clinical outcomes and cuff integrity between the 2 treatment groups at final follow-up; however, medial cuff failure was observed only in the SB group, and incomplete healing was more frequent in the medSR group. One should consider the risk of medial cuff failure and incomplete healing of the repaired cuff before choosing the repair technique for medium-sized supraspinatus tears.
LEVEL OF EVIDENCE


Level I, therapeutic, prospective, randomized trial.",2019,"This study did not show any significant differences in the clinical outcomes and cuff integrity between the 2 treatment groups at final follow-up; however, medial cuff failure was observed only in the SB group, and incomplete healing was more frequent in the medSR group.","['Medium-Sized Supraspinatus Tears', 'All patients were evaluated preoperatively and postoperatively (at 12 and 24\xa0months) using the modified University of California, Los Angeles scoring system; active range of motion (flexion and external rotation); and a visual analog scale for pain', 'patients with 1- to 3-cm tear sizes']","['suture bridge technique (SB) and the medially based single-row technique (medSR', 'Suture Bridge and Medially Based Single-Row Rotator Cuff Repair']","['Neo-tendon regeneration', 'incomplete healing', 'Healing status', 'medial cuff failure', 'University of California, Los Angeles scores', 'visual analog scale scores', 'clinical outcomes and cuff integrity', 'external rotation angles', 'active flexion angles', 'Medial cuff failure']","[{'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0439059', 'cui_str': 'Supraspinatus rupture'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0231462', 'cui_str': 'Lateral rotation - action (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0456378', 'cui_str': 'Type of bridge (attribute)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder (procedure)'}]","[{'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0349676', 'cui_str': 'Regeneration - action (qualifier value)'}, {'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C0231462', 'cui_str': 'Lateral rotation - action (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}]",,0.0220692,"This study did not show any significant differences in the clinical outcomes and cuff integrity between the 2 treatment groups at final follow-up; however, medial cuff failure was observed only in the SB group, and incomplete healing was more frequent in the medSR group.","[{'ForeName': 'Kotaro', 'Initials': 'K', 'LastName': 'Yamakado', 'Affiliation': 'Department of Orthopaedics, Fukui General Hospital, Fukui, Japan. Electronic address: yamakadok@gmail.com.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2019.05.026']
1787,30132426,Point-of-use water treatment improves recovery rates among children with severe acute malnutrition in Pakistan: results from a site-randomized trial.,"OBJECTIVE


To evaluate effectiveness of point-of-use water treatment in improving treatment of children affected by severe acute malnutrition (SAM).
DESIGN


Programme sites were randomized to one of four intervention arms: (i) standard SAM treatment; (ii) SAM treatment plus flocculent/disinfectant water treatment; (iii) SAM treatment plus chlorine disinfectant; or (iv) SAM treatment plus ceramic water filter. Outcome measures were calculated based on participant status upon exit or after 120d of enrolment, whichever came first. Child anthropometric data were collected during weekly monitoring at programme sites. Child caregivers were interviewed at enrolment and exit. Use of water treatment products was assessed in a home visit 4-6 weeks after enrolment.
SETTING


Dadu District, Sindh Province, Pakistan.
SUBJECTS


Children (n 901) aged 6-59 months with SAM and no medical complications.
RESULTS


Recovery rates were 16·7-22·2 % higher among children receiving water treatment compared with the control group. The adjusted odds of recovery were approximately twice as high for those receiving water treatment compared with controls. Mean length of stay until recovery was 73 (sd 24·6) d and mean rate of weight gain was 4·7 (sd 3·0) g/kg per d. Differences in recovery rate, length of stay and rate of weight gain between intervention groups were not statistically significant.
CONCLUSIONS


Incorporating point-of-use water treatment into outpatient treatment programmes for children with SAM increased nutritional recovery rates. No significant differences in recovery rates were observed between the different intervention groups, indicating that different water treatment approaches were equally effective in improving recovery.",2018,"No significant differences in recovery rates were observed between the different intervention groups, indicating that different water treatment approaches were equally effective in improving recovery.","['Dadu District, Sindh Province, Pakistan', 'Children (n 901) aged 6-59 months with SAM and no medical complications', 'children affected by severe acute malnutrition (SAM', 'children with SAM', 'children with severe acute malnutrition in Pakistan']",['standard SAM treatment; (ii) SAM treatment plus flocculent/disinfectant water treatment; (iii) SAM treatment plus chlorine disinfectant; or (iv) SAM treatment plus ceramic water filter'],"['recovery rates', 'Mean length of stay until recovery', 'Child anthropometric data', 'recovery rate, length of stay and rate of weight gain', 'nutritional recovery rates', 'mean rate of weight gain', 'Recovery rates']","[{'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1563296', 'cui_str': 'Systolic anterior movement of mitral valve'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1563296', 'cui_str': 'Systolic anterior movement of mitral valve'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0012682', 'cui_str': 'Disinfectants'}, {'cui': 'C0597684', 'cui_str': 'Water Treatment'}, {'cui': 'C0008209', 'cui_str': 'Chlorine'}, {'cui': 'C0007742', 'cui_str': 'Ceramics'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0180860', 'cui_str': 'Filter, device (physical object)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",901.0,0.0638827,"No significant differences in recovery rates were observed between the different intervention groups, indicating that different water treatment approaches were equally effective in improving recovery.","[{'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Doocy', 'Affiliation': '1Johns Hopkins Bloomberg School of Public Health,Department of International Health,615 N. Wolfe Street,Baltimore,MD 21205,US.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Tappis', 'Affiliation': '1Johns Hopkins Bloomberg School of Public Health,Department of International Health,615 N. Wolfe Street,Baltimore,MD 21205,US.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Villeminot', 'Affiliation': '2Action Against Hunger USA,New York,NY,USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Suk', 'Affiliation': '1Johns Hopkins Bloomberg School of Public Health,Department of International Health,615 N. Wolfe Street,Baltimore,MD 21205,US.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Kumar', 'Affiliation': '3Action Against Hunger Pakistan,Islamabad,Pakistan.'}, {'ForeName': 'Shahid', 'Initials': 'S', 'LastName': 'Fazal', 'Affiliation': '3Action Against Hunger Pakistan,Islamabad,Pakistan.'}, {'ForeName': 'Angeline', 'Initials': 'A', 'LastName': 'Grant', 'Affiliation': '2Action Against Hunger USA,New York,NY,USA.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Pietzsch', 'Affiliation': '2Action Against Hunger USA,New York,NY,USA.'}]",Public health nutrition,['10.1017/S1368980018001647']
1788,31531724,Letter to the Editor: Prophylactic Intraperitoneal Onlay Mesh Following Midline Laparotomy-Long-Term Results of a Randomized Controlled Trial.,,2020,,[],"['Letter to the Editor', 'Prophylactic Intraperitoneal Onlay Mesh']",[],[],"[{'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal (qualifier value)'}, {'cui': 'C0677511', 'cui_str': 'Onlay (qualifier value)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}]",[],,0.0532265,,"[{'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Stott', 'Affiliation': 'Department of Renal and Pancreas Transplantation, Manchester Royal Infirmary, Manchester University NHS Foundation Trust, Manchester, UK. martyn.stott@nhs.net.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Tarazi', 'Affiliation': 'Department of Renal and Pancreas Transplantation, Manchester Royal Infirmary, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shaw', 'Affiliation': 'Department of Renal and Pancreas Transplantation, Manchester Royal Infirmary, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Summers', 'Affiliation': 'Department of Renal and Pancreas Transplantation, Manchester Royal Infirmary, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Z M', 'Initials': 'ZM', 'LastName': 'Moinuddin', 'Affiliation': 'Department of Renal and Pancreas Transplantation, Manchester Royal Infirmary, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'van Dellen', 'Affiliation': 'Department of Renal and Pancreas Transplantation, Manchester Royal Infirmary, Manchester University NHS Foundation Trust, Manchester, UK.'}]",World journal of surgery,['10.1007/s00268-019-05187-5']
1789,32078409,Improved Conversation Outcomes After Social Communication Skills Training for People With Traumatic Brain Injury and Their Communication Partners: A Clinical Trial Investigating In-Person and Telehealth Delivery.,"Purpose The aim of the study was to investigate the effectiveness of social communication skills training (TBIconneCT) for people with traumatic brain injury (TBI) and their communication partners, delivered in-person or via telehealth, on quality of conversations. Method This study is a clinical trial, including an in-person intervention group ( n =  17), a telehealth intervention group ( n =  19), and a historical control group ( n =  15). Participants were adults at least 6 months post moderate-to-severe TBI with social communication skills deficits and their usual communication partners. Participants completed a casual and purposeful conversation task at pre-intervention, postintervention, and a follow-up assessment. A blinded assessor evaluated conversations using the Adapted Measure of Participation in Conversation and the Adapted Measure of Support in Conversation. Treatment effects were examined by comparing groups on change in ratings between pre- and posttraining. Maintenance of effects was examined using change between posttraining and follow-up assessment. The trial protocol was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12615001024538). Results Trained participants with TBI had significant improvements in participation in casual conversation compared to controls. Trained communication partners also had significant improvements compared to controls on ratings of support in casual conversations. However, treatment effects were not maintained at follow-up for two of eight measures. Comparisons between outcomes of in-person and telehealth groups found negligible to small effect sizes for six of eight measures. Conclusions The findings reinforce previous studies demonstrating the efficacy of communication partner training after TBI. Telehealth delivery produced similar outcomes to in-person delivery.",2020,Trained communication partners also had significant improvements compared to controls on ratings of support in casual conversations.,"['People With Traumatic Brain Injury and Their Communication Partners', 'people with traumatic brain injury (TBI) and their communication partners', 'Participants were adults at least 6 months post moderate-to-severe TBI with social communication skills deficits and their usual communication partners']","['telehealth intervention group', 'historical control group', 'Social Communication Skills Training', 'social communication skills training (TBIconneCT']","['participation in casual conversation', 'Improved Conversation Outcomes', 'ratings of support in casual conversations']","[{'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0588407', 'cui_str': 'Communication skills training (procedure)'}]","[{'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]",,0.0363856,Trained communication partners also had significant improvements compared to controls on ratings of support in casual conversations.,"[{'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Rietdijk', 'Affiliation': 'The University of Sydney, Sydney School of Health Sciences, New South Wales, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Power', 'Affiliation': 'The University of Sydney, Sydney School of Health Sciences, New South Wales, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Attard', 'Affiliation': 'The University of Sydney, Sydney School of Health Sciences, New South Wales, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Heard', 'Affiliation': 'The University of Sydney, Sydney School of Health Sciences, New South Wales, Australia.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Togher', 'Affiliation': 'The University of Sydney, Sydney School of Health Sciences, New South Wales, Australia.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2019_JSLHR-19-00076']
1790,31527093,Is faster better? A randomised crossover study comparing algorithms for closed-loop automatic oxygen control.,"OBJECTIVE


Closed-loop automatic control (CLAC) of the fractional inspired oxygen (FiO 2 ) improved oxygen administration to preterm infants on respiratory support. We investigated whether a revised CLAC algorithm (CLAC fast , ≤2 FiO 2  adjustments/min), compared with routine manual control (RMC only ), increased the proportion of time with arterial haemoglobin oxygen saturation measured by pulse oximetry within prespecified target ranges (Target%) while not being inferior to the original algorithm (CLAC slow : ≤0.3 FiO 2  adjustments/min).
DESIGN


Unblinded randomised controlled crossover study comparing three modes of FiO 2  control in random order for 8 hours each: RMC supported by CLAC fast  was compared with RMC only  and RMC supported by CLAC slow . A computer-generated list of random numbers using a block size of six was used for the allocation sequence.
SETTING


Two German tertiary university neonatal intensive care units.
PATIENTS


Of 23 randomised patients, 19 were analysed (mean±SD gestational age 27±2 weeks; age at randomisation 24±10 days) on non-invasive (n=18) or invasive (n=1) respiratory support at FiO 2  >0.21.
MAIN OUTCOME MEASURE


Target%.
RESULTS


Mean±SD [95% CI] Target% was 68%±11% [65% to 71%] for CLAC fast  versus 65%±11% [61% to 68%] for CLAC slow  versus 58%±11% [55% to 62%] for RMC only . Prespecified hypothesis tests of: (A) superiority of CLAC fast  versus RMC only  and (B) non-inferiority of CLAC fast  versus CLAC slow  with margin of 5% yielded one-sided p values of <0.001 for both comparisons.
CONCLUSIONS


This revised and faster CLAC algorithm was still superior to routine care in infants on respiratory support and not inferior to a previously tested slower algorithm.
TRIAL REGISTRATION NUMBER


NCT03163108.",2020,"This revised and faster CLAC algorithm was still superior to routine care in infants on respiratory support and not inferior to a previously tested slower algorithm.
","['Two German tertiary university neonatal intensive care units', 'preterm infants on respiratory support', 'Of 23 randomised patients, 19 were analysed (mean±SD gestational age 27±2 weeks; age at randomisation 24±10 days) on non-invasive (n=18) or invasive (n=1) respiratory support at FiO 2  >0.21']","['closed-loop automatic oxygen control', 'Mean±SD', 'Closed-loop automatic control (CLAC) of the fractional inspired oxygen (FiO 2 ) improved oxygen administration']",['proportion of time with arterial haemoglobin oxygen saturation'],"[{'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C4517437', 'cui_str': '0.21 (qualifier value)'}]","[{'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}]",,0.198641,"This revised and faster CLAC algorithm was still superior to routine care in infants on respiratory support and not inferior to a previously tested slower algorithm.
","[{'ForeName': 'Christoph E', 'Initials': 'CE', 'LastName': 'Schwarz', 'Affiliation': ""Department of Neonatology, University Children's Hospital, Tuebingen, Germany C.Schwarz@med.uni-tuebingen.de.""}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Kidszun', 'Affiliation': 'Department of Neonatology, University Medical Centre of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Nicole S', 'Initials': 'NS', 'LastName': 'Bieder', 'Affiliation': ""Department of Neonatology, University Children's Hospital, Tuebingen, Germany.""}, {'ForeName': 'Axel R', 'Initials': 'AR', 'LastName': 'Franz', 'Affiliation': ""Department of Neonatology, University Children's Hospital, Tuebingen, Germany.""}, {'ForeName': 'Jochem', 'Initials': 'J', 'LastName': 'König', 'Affiliation': 'Division of Paediatric Epidemiology, Institute of Medical Biostatistics, Epidemiology and Informatics, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Mildenberger', 'Affiliation': 'Department of Neonatology, University Medical Centre of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Christian F', 'Initials': 'CF', 'LastName': 'Poets', 'Affiliation': ""Department of Neonatology, University Children's Hospital, Tuebingen, Germany.""}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Seyfang', 'Affiliation': 'Division of Paediatric Epidemiology, Institute of Medical Biostatistics, Epidemiology and Informatics, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Urschitz', 'Affiliation': 'Division of Paediatric Epidemiology, Institute of Medical Biostatistics, Epidemiology and Informatics, University Medical Center Mainz, Mainz, Germany.'}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2019-317029']
1791,31697587,Bevacizumab As Maintenance Treatment in Patients With Ovarian Cancer: Wait for  BRCA  Testing.,,2020,,['Patients With Ovarian Cancer'],['Bevacizumab'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}]",[],,0.0204737,,"[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Farolfi', 'Affiliation': 'Alberto Farolfi, MD, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, IRCCS, Meldola, Italy; Domenica Lorusso, MD, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome, Italy; Sandro Pignata, MD, PhD, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Naples, Italy; and Ugo De Giorgi, MD, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, IRCCS, Meldola, Italy.'}, {'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Lorusso', 'Affiliation': 'Alberto Farolfi, MD, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, IRCCS, Meldola, Italy; Domenica Lorusso, MD, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome, Italy; Sandro Pignata, MD, PhD, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Naples, Italy; and Ugo De Giorgi, MD, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, IRCCS, Meldola, Italy.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Pignata', 'Affiliation': 'Alberto Farolfi, MD, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, IRCCS, Meldola, Italy; Domenica Lorusso, MD, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome, Italy; Sandro Pignata, MD, PhD, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Naples, Italy; and Ugo De Giorgi, MD, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, IRCCS, Meldola, Italy.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'De Giorgi', 'Affiliation': 'Alberto Farolfi, MD, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, IRCCS, Meldola, Italy; Domenica Lorusso, MD, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome, Italy; Sandro Pignata, MD, PhD, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Naples, Italy; and Ugo De Giorgi, MD, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, IRCCS, Meldola, Italy.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02055']
1792,31056655,High Flavonoid Cocoa Supplement Ameliorates Plasma Oxidative Stress and Inflammation Levels While Improving Mobility and Quality of Life in Older Subjects: A Double-Blind Randomized Clinical Trial.,"BACKGROUND


The age-related decline in mass, strength, and performance of skeletal muscle is associated with loss of independence, falls risk, disability, institutionalization, and death.
METHODS


To determine whether a cocoa supplement enriched in flavonoids can improve plasma markers of oxidative stress and inflammation, physical performance and frailty in middle-aged and older subjects, we conducted a two-phase, randomized, double-blind, clinical trial. The initial study included 60 subjects (55- to 70-year-old) allocated into placebo (P), highly alkalinized (no-flavonoid; NF), or flavonoid-rich natural cocoa (F) beverage groups. The follow-up study included 74 older subjects (65- to 90-year-old) randomly distributed into NF or F groups. Subjects were instructed to consume the beverages once/day for up to 12-weeks. A comprehensive (aging relevant) set of end points were assessed, which included mean change in blood plasma metabolic and oxidative stress indicators, in physical performance tests and quality of life (QoL).
RESULTS


In the initial study, the F group showed improved glycemia, triglyceridemia, High-density lipoprotein cholesterol, Low-density lipoprotein cholesterol, triglyceridemia/HDL index, and oxidative markers. Performance on the Up and Go test, skeletal muscle index, and quality of life also improved. In the follow-up study, F treatment was associated with significant improvements in metabolic, oxidative stress, and inflammatory endpoints and positive effects on physical performance, frailty indicators, and quality of life (F vs. NF group).
CONCLUSIONS


Regular flavonoids consumption positively affects blood oxidative stress and inflammation end points, cardiometabolic risk markers, physical performance, and quality of life. The sum of such effects may help to mitigate the extent of frailty development in the elderly people.
TRIAL REGISTRATION


NCT03585868.",2019,"In the follow-up study, F treatment was associated with significant improvements in metabolic, oxidative stress and inflammatory endpoints and positive effects on physical performance, frailty indicators and QoL (F vs. NF group).
","['74 older subjects (65-90 year-old) randomly distributed into NF or F groups', 'middle and older age subjects', '60 subjects (55-70 year-old) allocated into', 'older subjects']","['cocoa supplement enriched in flavonoids', 'placebo (P), highly alkalinized (no-flavonoid; NF) or flavonoid rich natural cocoa (F) beverage groups', 'High flavonoid cocoa supplement']","['impact blood oxidative stress and inflammation endpoints, cardiometabolic risk markers, physical performance and QoL', 'Performance on the Up & Go test, skeletal muscle index, and QoL', 'plasma markers of oxidative stress and inflammation, physical performance and frailty', 'blood plasma metabolic and oxidative stress indicators, in physical performance tests and quality of life (QoL', 'mobility and quality of life', 'plasma oxidative stress and inflammation levels', 'glycemia, triglyceridemia (TG), c-HDL, c-LDL, the TG/HDL index, and oxidative markers', 'metabolic, oxidative stress and inflammatory endpoints and positive effects on physical performance, frailty indicators and QoL']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C1999167', 'cui_str': 'Old-age (finding)'}]","[{'cui': 'C4521844', 'cui_str': 'Cocoa'}, {'cui': 'C0596577', 'cui_str': 'Flavonoids'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2607857'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0034380'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",74.0,0.48685,"In the follow-up study, F treatment was associated with significant improvements in metabolic, oxidative stress and inflammatory endpoints and positive effects on physical performance, frailty indicators and QoL (F vs. NF group).
","[{'ForeName': 'Levy', 'Initials': 'L', 'LastName': 'Munguia', 'Affiliation': 'Seccion de Estudios de Posgrado e Investigacion, Escuela Superior de Medicina, Mexico.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Rubio-Gayosso', 'Affiliation': 'Seccion de Estudios de Posgrado e Investigacion, Escuela Superior de Medicina, Mexico.'}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Ramirez-Sanchez', 'Affiliation': 'Seccion de Estudios de Posgrado e Investigacion, Escuela Superior de Medicina, Mexico.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Ortiz', 'Affiliation': 'Departamento de Ingenieria Bioquimica, Escuela Nacional de Ciencias Biologicas, Instituto Politecnico Nacional, Mexico.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Hidalgo', 'Affiliation': 'Seccion de Estudios de Posgrado e Investigacion, Escuela Superior de Medicina, Mexico.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Gonzalez', 'Affiliation': 'Seccion de Estudios de Posgrado e Investigacion, Escuela Superior de Medicina, Mexico.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Meaney', 'Affiliation': 'Seccion de Estudios de Posgrado e Investigacion, Escuela Superior de Medicina, Mexico.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Villarreal', 'Affiliation': 'Department of Medicine, School of Medicine, University of California San Diego, La Jolla.'}, {'ForeName': 'Nayelli', 'Initials': 'N', 'LastName': 'Najera', 'Affiliation': 'Seccion de Estudios de Posgrado e Investigacion, Escuela Superior de Medicina, Mexico.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Ceballos', 'Affiliation': 'Seccion de Estudios de Posgrado e Investigacion, Escuela Superior de Medicina, Mexico.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glz107']
1793,30726886,Walking for Better Outcomes and Recovery: The Effect of WALK-FOR in Preventing Hospital-Associated Functional Decline Among Older Adults.,"BACKGROUND


In-hospital immobility of older adults is associated with hospital-associated functional decline (HAFD). This study examined the WALK-FOR program's effects on HAFD prevention.
METHODS


A quasi-experimental pre-post two-group (intervention group [IG] n = 188, control group [CG] n = 189) design was applied in two hospital internal medical units. On admission, patients reported pre-hospitalization functional status, which was assessed again at discharge and 1-month follow-up. Primary outcome was decline in basic activities of daily living (BADL), using the Modified Barthel Index. Secondary outcomes were decline in instrumental ADL (Lawton's IADL scale) and community mobility (Yale Physical Activity Survey). All participants (75.1 ± 7 years old) were cognitively intact and ambulatory at admission. The WALK-FOR included a unit-tailored mobility program utilizing patient-and-staff education with a specific mobility goal (900 steps per day), measured by accelerometer.
RESULTS


Decline in BADL occurred among 33% of the CG versus 23% of the IG (p = .02) at discharge, and among 43% of the CG versus 30% in the IG (p = .01) at 1-month follow-up. Similarly, 26% of the CG versus 15% of the IG declined in community mobility at 1-month follow-up (p = .01). Adjusted for major covariates, the intervention reduced the odds of decline in BADL by 41% (p = .05) at discharge and by 49% at 1-month follow-up (p = .01), and in community mobility by 63% (p = .02). There was no significant effect of the intervention on IADL decline (p = .19).
CONCLUSIONS


The WALK-FOR intervention is effective in reducing HAFD.",2019,"Results


Decline in BADL occurred among 33% of the CG versus 23% of the IG (p = 0.02) at discharge, and among 43% of the CG versus 30% in the IG (p = 0.01) at 1-month follow-up.","['188, control group [CG] n\xa0', 'All participants (75.1\xa0±\xa07 years old) were cognitively intact and ambulatory at admission', 'older adults']","['WALK-FOR intervention', 'Methods\n\n\nA quasi-experimental pre-post two-group (intervention group [IG] n\xa0', 'WALK-FOR']","['community mobility', 'decline in basic activities of daily living (BADL), using the Modified Barthel Index (MBI', 'BADL', 'IADL decline', ""decline in instrumental ADL (Lawton's IADL scale) and community mobility (Yale Physical Activity Survey""]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441848', 'cui_str': 'Group N (qualifier value)'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C1290927', 'cui_str': 'Basic activity of daily living (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C1290928', 'cui_str': 'Instrumental activity of daily living (observable entity)'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living (assessment scale)'}, {'cui': 'C0222045'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",,0.0233814,"Results


Decline in BADL occurred among 33% of the CG versus 23% of the IG (p = 0.02) at discharge, and among 43% of the CG versus 30% in the IG (p = 0.01) at 1-month follow-up.","[{'ForeName': 'Yaniv', 'Initials': 'Y', 'LastName': 'Cohen', 'Affiliation': 'Department of Gerontology, Faculty of Social Welfare and Health Sciences, University of Haifa, Israel.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Zisberg', 'Affiliation': 'The Cheryl Spencer Department of Nursing, Faculty of Social Welfare and Health Science, University of Haifa, Israel.'}, {'ForeName': 'Yehudit', 'Initials': 'Y', 'LastName': 'Chayat', 'Affiliation': 'HaEmek Medical Center, Clalit Health Services, Afula, Israel.'}, {'ForeName': 'Nurit', 'Initials': 'N', 'LastName': 'Gur-Yaish', 'Affiliation': 'The Cheryl Spencer Department of Nursing, Faculty of Social Welfare and Health Science, University of Haifa, Israel.'}, {'ForeName': 'Efrat', 'Initials': 'E', 'LastName': 'Gil', 'Affiliation': 'Clalit Health Services, Haifa and West Galilee and Carmel Hospital, Israel.'}, {'ForeName': 'Chedva', 'Initials': 'C', 'LastName': 'Levin', 'Affiliation': 'The Cheryl Spencer Department of Nursing, Faculty of Social Welfare and Health Science, University of Haifa, Israel.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Rand', 'Affiliation': 'Department of Occupational Therapy, School of Health Professions, Sackler Faculty of Medicine, Tel-Aviv University, Israel.'}, {'ForeName': 'Maayan', 'Initials': 'M', 'LastName': 'Agmon', 'Affiliation': 'The Cheryl Spencer Department of Nursing, Faculty of Social Welfare and Health Science, University of Haifa, Israel.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glz025']
1794,30946156,Cardiorespiratory fitness is associated with inflammation and physical activity in HIV+ adults.,"OBJECTIVE


Our objective was to examine the effect of a lifestyle diet and exercise intervention on cardiorespiratory fitness (CRF) and to examine predictors of change in CRF.
DESIGN


People living with HIV (PLHIV) are at increased risk for cardiovascular disease. CRF is a better predictor of cardiovascular disease-related mortality than established risk factors yet very little is known about CRF in PLHIV.
METHODS


One-hundred and seven virally suppressed PLHIV were randomized to a group-based intervention to improve lifestyle behaviors or a control condition. All PLHIV maximal cardiorespiratory stress test to determine VO2 peak, VO2 at anaerobic threshold, and ventilatory efficiency/VCO2, at baseline and 6 months later. Participants wore an accelerometer to measure physical activity, completed waist-hip circumference measures, and had a fasting lipid profile, IL-6, and high sensitivity C-reactive protein analyzed. Generalized estimating equations were used to examine the effect of the intervention on CRF and predictors of change in CRF.
RESULTS


Participants were approximately 53 years old, 65% male (n = 70), and 86% African-American (n = 93). There was no effect of the intervention on markers of CRF over time (P > 0.05). After controlling for age, sex, waist-hip-ratio, the inflammatory biomarker IL-6 was inversely associated with a decline in both VO2 peak (P = 0.03) and VO2 at anaerobic threshold (P = 0.03). In addition, participants who walked an additional 10 000 steps per day had a 2.69 ml/kg per min higher VO2 peak (P = 0.02).
CONCLUSION


Despite HIV viral suppression, PLHIV had remarkably poor CRF and inflammation was associated with a clinically adverse CRF profile. However, increased physical activity was associated with improved CRF.",2019,There was no effect of the intervention on markers of CRF over time (P > 0.05).,"['People living with HIV (PLHIV', 'HIV+ adults', 'Participants were approximately 53 years old, 65% male (n\u200a=\u200a70), and 86% African-American (n\u200a=\u200a93', 'One-hundred and seven virally suppressed PLHIV']","['CRF', 'lifestyle diet and exercise intervention', 'group-based intervention to improve lifestyle behaviors or a control condition']","['VO2 peak', 'markers of CRF over time', 'cardiorespiratory fitness (CRF', 'VO2 peak, VO2 at anaerobic threshold, and ventilatory efficiency/VCO2', 'HIV viral suppression', 'physical activity', 'CRF and inflammation']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}]","[{'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C1701256', 'cui_str': 'bis(acetylacetonato)oxovanadium(IV)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",107.0,0.057033,There was no effect of the intervention on markers of CRF over time (P > 0.05).,"[{'ForeName': 'Allison R', 'Initials': 'AR', 'LastName': 'Webel', 'Affiliation': 'Frances Payne Bolton School of Nursing, Case Western Reserve University.'}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Jenkins', 'Affiliation': 'Division of Cardiovascular Medicine, Case Western Reserve University School of Medicine.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vest', 'Affiliation': 'University Hospitals Harrington Heart and Vascular Institute, Cleveland, Ohio, USA.'}, {'ForeName': 'Vitor H F', 'Initials': 'VHF', 'LastName': 'Oliveira', 'Affiliation': 'Department of Exercise Physiology, State University of Londrina, Londrina, Brazil.'}, {'ForeName': 'Chris T', 'Initials': 'CT', 'LastName': 'Longenecker', 'Affiliation': 'Division of Cardiovascular Medicine, Case Western Reserve University School of Medicine.'}, {'ForeName': 'Jintao', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Frances Payne Bolton School of Nursing, Case Western Reserve University.'}, {'ForeName': 'Jackson', 'Initials': 'J', 'LastName': 'Currie', 'Affiliation': 'Frances Payne Bolton School of Nursing, Case Western Reserve University.'}, {'ForeName': 'Abdus', 'Initials': 'A', 'LastName': 'Sattar', 'Affiliation': 'Frances Payne Bolton School of Nursing, Case Western Reserve University.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Josephson', 'Affiliation': 'Division of Cardiovascular Medicine, Case Western Reserve University School of Medicine.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002154']
1795,32430458,Efficacy and Safety of Insulin Glargine 300 Units/mL (Gla-300) Versus Insulin Glargine 100 Units/mL (Gla-100) in Children and Adolescents (6-17 years) With Type 1 Diabetes: Results of the EDITION JUNIOR Randomized Controlled Trial.,"OBJECTIVE


To compare efficacy and safety of insulin glargine 300 units/mL (Gla-300) and 100 units/mL (Gla-100) in children and adolescents (6-17 years old) with type 1 diabetes.
RESEARCH DESIGN AND METHODS


EDITION JUNIOR was a noninferiority, international, open-label, two-arm, parallel-group, phase 3b trial. Participants were randomized 1:1 to Gla-300 or Gla-100, titrated to achieve fasting self-monitored plasma glucose levels of 90-130 mg/dL (5.0-7.2 mmol/L), with continuation of prior prandial insulin. The primary end point was change in HbA 1c  from baseline to week 26. Other assessments included change in fasting plasma glucose (FPG), hypoglycemia, hyperglycemia with ketosis, and adverse events.
RESULTS


In 463 randomized participants (Gla-300,  n  = 233; Gla-100,  n  = 230), comparable least squares (LS) mean (SE) reductions in HbA 1c  were observed from baseline to week 26 (-0.40% [0.06%] for both groups), with LS mean between-group difference of 0.004% (95% CI -0.17 to 0.18), confirming noninferiority at the prespecified 0.3% (3.3 mmol/mol) margin. Mean FPG change from baseline to week 26 was also similar between groups. During the 6-month treatment period, incidence and event rates of severe or documented (≤70 mg/dL [≤3.9 mmol/L]) hypoglycemia were similar between groups. Incidence of severe hypoglycemia was 6.0% with Gla-300 and 8.8% with Gla-100 (relative risk 0.68 [95% CI 0.35-1.30]). Incidence of any hyperglycemia with ketosis was 6.4% with Gla-300 and 11.8% with Gla-100.
CONCLUSIONS


Gla-300 provided similar glycemic control and safety profiles to Gla-100 in children and adolescents with type 1 diabetes, indicating that Gla-300 is a suitable therapeutic option in this population.",2020,"Gla-300 provided similar glycemic control and safety profiles to Gla-100 in children and adolescents with type 1 diabetes, indicating that Gla-300 is a suitable therapeutic option in this population.","['With Type 1 Diabetes', 'children and adolescents (6-17 years old) with type 1 diabetes', 'Children and Adolescents (6-17 years', 'children and adolescents with type 1 diabetes']","['insulin glargine 300 units/mL (Gla-300) and 100 units/mL (Gla-100', 'Gla-300', 'Insulin Glargine 300 Units/mL', 'Insulin Glargine 100 Units/mL (Gla-100', 'Gla-300 or Gla-100, titrated to achieve fasting self-monitored plasma glucose levels of 90-130 mg/dL']","['Efficacy and Safety', 'Mean FPG change', 'change in HbA 1c', 'fasting plasma glucose (FPG), hypoglycemia, hyperglycemia with ketosis, and adverse events', 'incidence and event rates of severe', 'Incidence of severe hypoglycemia', 'Incidence of any hyperglycemia with ketosis', 'hypoglycemia', 'efficacy and safety']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C2945590', 'cui_str': 'U/mL'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0061078', 'cui_str': 'gamolenic acid'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0022638', 'cui_str': 'Ketosis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}]",463.0,0.0547279,"Gla-300 provided similar glycemic control and safety profiles to Gla-100 in children and adolescents with type 1 diabetes, indicating that Gla-300 is a suitable therapeutic option in this population.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Danne', 'Affiliation': ""Children's Hospital AUF DER BULT, Hannover Medical School, Hannover, Germany danne@hka.de.""}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'Tamborlane', 'Affiliation': 'Department of Pediatrics, Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Oleg A', 'Initials': 'OA', 'LastName': 'Malievsky', 'Affiliation': 'Department of Pediatrics, Bashkir State Medical University, Ufa, Russian Federation.'}, {'ForeName': 'Denise R', 'Initials': 'DR', 'LastName': 'Franco', 'Affiliation': 'CPCLIN Clinical Research Center, São Paulo, Brazil.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Kawamura', 'Affiliation': 'Department of Pediatrics, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Demissie', 'Affiliation': 'Sanofi, Frankfurt, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Niemoeller', 'Affiliation': 'Sanofi, Frankfurt, Germany.'}, {'ForeName': 'Harmonie', 'Initials': 'H', 'LastName': 'Goyeau', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Wardecki', 'Affiliation': 'Sanofi, Warsaw, Poland.'}, {'ForeName': 'Tadej', 'Initials': 'T', 'LastName': 'Battelino', 'Affiliation': ""UMC - University Children's Hospital and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.""}]",Diabetes care,['10.2337/dc19-1926']
1796,31618132,Clinicogenomic Radiotherapy Classifier Predicting the Need for Intensified Locoregional Treatment After Breast-Conserving Surgery for Early-Stage Breast Cancer.,"PURPOSE


Most patients with early-stage breast cancer are treated with adjuvant radiotherapy (RT) after breast-conserving surgery (BCS) to prevent locoregional recurrence (LRR). However, no genomic tools are used currently to select the optimal RT strategy.
METHODS


We profiled the transcriptome of primary tumors on a clinical grade assay from the SweBCG91-RT trial, in which patients with node-negative breast cancer were randomly assigned to either whole-breast RT after BCS or no RT. We derived a new classifier, Adjuvant Radiotherapy Intensification Classifier (ARTIC), comprising 27 genes and patient age, in three publicly available cohorts, then independently validated ARTIC for LRR in 748 patients in SweBCG91-RT. We also compared previously published genomic signatures for ability to predict benefit from RT in SweBCG91-RT.
RESULTS


ARTIC was highly prognostic for LRR in patients treated with RT (hazard ratio [HR], 3.4; 95% CI, 2.0 to 5.9;  P  < .001) and predictive of RT benefit ( P interaction  = .005). Patients with low ARTIC scores had a large benefit from RT (HR, 0.33 [95% CI, 0.21 to 0.52],  P  < .001; 10-year cumulative incidence of LRR, 6%  v  21%), whereas those with high ARTIC scores benefited less from RT (HR, 0.73 [95% CI, 0.44 to 1.2],  P  = .23; 10-year cumulative incidence of LRR, 25%  v  32%). In contrast, none of the eight previously published signatures were predictive of benefit from RT in SweBCG91-RT.
CONCLUSION


ARTIC identified women with a substantial benefit from RT as well as women with a particularly elevated LRR risk in whom whole-breast RT was not sufficiently effective and, thus, in whom intensified treatment strategies such as tumor-bed boost, and possibly regional nodal RT, should be considered. To our knowledge, ARTIC is the first classifier validated as predictive of benefit from RT in a phase III clinical trial with patients randomly assigned to receive or not receive RT.",2019,"Patients with low ARTIC scores had a large benefit from RT (HR, 0.33","['patients with node-negative breast cancer', 'Early-Stage Breast Cancer', '748 patients in SweBCG91-RT', 'patients with early-stage breast cancer']","['whole-breast RT after BCS or no RT', 'adjuvant radiotherapy (RT) after breast-conserving surgery (BCS', 'Clinicogenomic Radiotherapy Classifier']",['predictive of RT benefit'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3160889', 'cui_str': 'Node-negative breast cancer'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0457102', 'cui_str': 'Whole breast (qualifier value)'}, {'cui': 'C0242939', 'cui_str': 'Radiotherapy, Adjuvant'}, {'cui': 'C0917927', 'cui_str': 'Breast-Conserving Surgery'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]",[],748.0,0.0539045,"Patients with low ARTIC scores had a large benefit from RT (HR, 0.33","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sjöström', 'Affiliation': 'Lund University, Lund, Sweden.'}, {'ForeName': 'S Laura', 'Initials': 'SL', 'LastName': 'Chang', 'Affiliation': 'PFS Genomics, Vancouver, Canada.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Fishbane', 'Affiliation': 'Decipher Biosciences, Vancouver, Canada.'}, {'ForeName': 'Elai', 'Initials': 'E', 'LastName': 'Davicioni', 'Affiliation': 'Decipher Biosciences, Vancouver, Canada.'}, {'ForeName': 'Shuang G', 'Initials': 'SG', 'LastName': 'Zhao', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MI.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Hartman', 'Affiliation': 'Lund University, Lund, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Holmberg', 'Affiliation': 'Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Felix Y', 'Initials': 'FY', 'LastName': 'Feng', 'Affiliation': 'University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Corey W', 'Initials': 'CW', 'LastName': 'Speers', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MI.'}, {'ForeName': 'Lori J', 'Initials': 'LJ', 'LastName': 'Pierce', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MI.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Malmström', 'Affiliation': 'Lund University, Lund, Sweden.'}, {'ForeName': 'Mårten', 'Initials': 'M', 'LastName': 'Fernö', 'Affiliation': 'Lund University, Lund, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Karlsson', 'Affiliation': 'Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00761']
1797,31843628,Simultaneous EEG/fMRI recorded during ketamine infusion in patients with major depressive disorder.,"A single subanaesthetic dose of ketamine rapidly alleviates the symptoms of major depressive disorder (MDD). However, few studies have investigated the acute effects of ketamine on the BOLD pharmacological magnetic resonance imaging (phMRI) response and EEG spectra. In a randomised, double-blind, active placebo-controlled crossover trial, resting-state simultaneous EEG/fMRI was collected during infusion of ketamine or active placebo (remifentanil) in 30 participants with MDD. Montgomery-Asberg depression rating scale scores showed a significant antidepressant effect of ketamine compared to placebo (69% response rate). phMRI analyses showed BOLD signal increases in the anterior cingulate and medial prefrontal cortices and sensitivity of the decrease in subgenual anterior cingulate cortex (sgACC) BOLD signal to noise correction. EEG spectral analysis showed increased theta, high beta, low and high gamma power, and decreased delta, alpha, and low beta power with differing time-courses. Low beta and high gamma power time courses explained significant variance in the BOLD signal. Interestingly, the variance explained by high gamma power was significantly associated with non-response to ketamine, but significant associations were not found for other neurophysiological markers when noise correction was implemented. The results suggest that the decrease in sgACC BOLD signal is potentially noise and unrelated to ketamine's antidepressant effect, highlighting the importance of noise correction and multiple temporal regressors for phMRI analyses. The lack of effects significantly associated with antidepressant response suggests the phMRI methodology employed was unable to detect such effects, the effect sizes are relatively small, or that other processes, e.g. neural plasticity, underlie ketamine's antidepressant effect.",2020,phMRI analyses showed BOLD signal increases in the anterior cingulate and medial prefrontal cortices and sensitivity of the decrease in subgenual anterior cingulate cortex (sgACC) BOLD signal to noise correction.,"['patients with major depressive disorder', '30 participants with MDD']","['ketamine infusion', 'ketamine or active placebo (remifentanil', 'placebo', 'ketamine', 'active placebo']","['Montgomery-Asberg depression rating scale scores', 'sgACC BOLD signal', 'Simultaneous EEG/fMRI', 'BOLD signal', 'theta, high beta, low and high gamma power, and decreased delta, alpha, and low beta power', 'subgenual anterior cingulate cortex (sgACC) BOLD signal to noise correction', 'symptoms of major depressive disorder (MDD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}]","[{'cui': 'C4706358', 'cui_str': 'MADRS (Montgomery-Asberg Depression Rating Scale) score'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1552644', 'cui_str': 'Greek letter gamma'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]",30.0,0.0891242,phMRI analyses showed BOLD signal increases in the anterior cingulate and medial prefrontal cortices and sensitivity of the decrease in subgenual anterior cingulate cortex (sgACC) BOLD signal to noise correction.,"[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'McMillan', 'Affiliation': 'School of Pharmacy, University of Auckland, New Zealand. Electronic address: rgra126@aucklanduni.ac.nz.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Sumner', 'Affiliation': 'School of Pharmacy, University of Auckland, New Zealand.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Forsyth', 'Affiliation': 'School of Pharmacy, University of Auckland, New Zealand.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Campbell', 'Affiliation': 'Department of Anaesthesiology, Auckland District Health Board, New Zealand.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Malpas', 'Affiliation': 'Department of Anaesthesiology, Auckland District Health Board, New Zealand.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Maxwell', 'Affiliation': 'Department of Anaesthesiology, Auckland District Health Board, New Zealand.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Deng', 'Affiliation': 'Department of Anaesthesiology, Auckland District Health Board, New Zealand.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hay', 'Affiliation': 'Department of Anaesthesiology, Auckland District Health Board, New Zealand.'}, {'ForeName': 'Rhys', 'Initials': 'R', 'LastName': 'Ponton', 'Affiliation': 'School of Pharmacy, University of Auckland, New Zealand.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Sundram', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, New Zealand.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Muthukumaraswamy', 'Affiliation': 'School of Pharmacy, University of Auckland, New Zealand.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2019.109838']
1798,31550199,Efficacy of Nursing Support in the Pre- and Postmedical Termination of Pregnancy Phases: A Randomized Study.,"This study was conducted to evaluate the efficiency of a nursing support program developed in accordance with the Roy adaptation model that was applied in addition to routine nursing care during the treatment process of pregnant women for whom the medical termination decision. This study, which was conducted using a pretest-posttest design, was a prospective, single-blind, and randomized-controlled empirical study. In the experimental group, although the first and last assessment State Anxiety Inventory scores were higher than those in the control group after the medical termination nursing support program, there was no significant difference. Compared with the control group, there were positive differences in the Scale of Ways of Coping with Stress, Adaptation Assessment Form for Role Function Area, and physical complaints in the experimental group. At the follow-up assessment, the total Perinatal Grief Scale score was significantly higher than that in the control group.",2019,,[],['Nursing Support'],[],[],"[{'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]",[],,0.0678589,,"[{'ForeName': 'Meltem', 'Initials': 'M', 'LastName': 'Mecdi Kaydirak', 'Affiliation': 'Department of Obstetrics and Gynecologic Nursing, Florence Nightingale Faculty of Nursing, Istanbul University - Cerrahpasa, Turkey.'}, {'ForeName': 'Ergül', 'Initials': 'E', 'LastName': 'Aslan', 'Affiliation': 'Department of Obstetrics and Gynecologic Nursing, Florence Nightingale Faculty of Nursing, Istanbul University - Cerrahpasa, Turkey.'}]",Omega,['10.1177/0030222819877791']
1799,31567287,"CORR Insights®: Does Robotic-assisted TKA Result in Better Outcome Scores or Long-Term Survivorship Than Conventional TKA? A Randomized, Controlled Trial.",,2020,,[],['CORR Insights®'],[],[],[],[],,0.24247,,"[{'ForeName': 'Lawrence D', 'Initials': 'LD', 'LastName': 'Dorr', 'Affiliation': 'L. D. Dorr, Dorr Institute for Research and Education, Pasadena, CA, USA.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000000969']
1800,31565781,Modelling Forced Vital Capacity in Idiopathic Pulmonary Fibrosis: Optimising Trial Design.,"INTRODUCTION


Forced vital capacity is the only registrational endpoint in idiopathic pulmonary fibrosis clinical trials. As most new treatments will be administered on top of standard of care, estimating treatment response will become more challenging. We developed a simulation model to quantify variability associated with forced vital capacity decline.
METHODS


The model is based on publicly available clinical trial summary and home spirometry data. A single, illustrative trial setting is reported. Model assumptions are 400 subjects randomised 1:1 to investigational drug or placebo over 52 weeks, 50% of each group receiving standard of care (all-comer population), and a 90-mL treatment difference in annual forced vital capacity decline. Longitudinal profiles were simulated and the impact of varying clinical scenarios evaluated.
RESULTS


Power to detect a significant treatment difference was 87-97%, depending on the analysis method. Repeated measures analysis generally outperformed analysis of covariance and mixed linear models, particularly with missing data (as simulated data were non-linear). A 15% yearly random dropout rate led to 0.6-5% power loss. Forced vital capacity decline-related dropout introduced greater power loss (up to 12%), as did subjects starting/stopping standard of care or investigational drug. Power was substantially lower for a 26-week trial due to the smaller assumed treatment effect at week 26 (sample size would need doubling to reach a power similar to that of a 52-week trial).
CONCLUSIONS


Our model quantifies forced vital capacity decline and associated variability, with all the caveats of background therapy, permitting robust power calculations to inform future idiopathic pulmonary fibrosis clinical trial design.
FUNDING


Galapagos NV (Mechelen, Belgium).",2019,"Forced vital capacity decline-related dropout introduced greater power loss (up to 12%), as did subjects starting/stopping standard of care or investigational drug.","['400 subjects randomised 1:1 to', 'Idiopathic Pulmonary Fibrosis']",['investigational drug or placebo'],[],"[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0085786', 'cui_str': 'Alveolitis, Fibrosing'}]","[{'cui': 'C0013230', 'cui_str': 'Investigational New Drugs'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],400.0,0.145621,"Forced vital capacity decline-related dropout introduced greater power loss (up to 12%), as did subjects starting/stopping standard of care or investigational drug.","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Santermans', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ford', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kreuter', 'Affiliation': 'Centre for Interstitial and Rare Lung Diseases, Pneumology, Thoraxklinik, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Verbruggen', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Meyvisch', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Wim A', 'Initials': 'WA', 'LastName': 'Wuyts', 'Affiliation': 'Unit for Interstitial Lung Diseases, Department of Pulmonary Medicine, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Kevin K', 'Initials': 'KK', 'LastName': 'Brown', 'Affiliation': 'Department of Medicine, National Jewish Health, Denver, CO, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Lederer', 'Affiliation': 'Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Byrne', 'Affiliation': 'Fibrosis Research Group, National Heart and Lung Institute, Imperial College, London, UK.'}, {'ForeName': 'Philip L', 'Initials': 'PL', 'LastName': 'Molyneaux', 'Affiliation': 'Fibrosis Research Group, National Heart and Lung Institute, Imperial College, London, UK.'}, {'ForeName': 'Arunon', 'Initials': 'A', 'LastName': 'Sivananthan', 'Affiliation': 'Fibrosis Research Group, National Heart and Lung Institute, Imperial College, London, UK.'}, {'ForeName': 'Catharina C', 'Initials': 'CC', 'LastName': 'Moor', 'Affiliation': 'Department of Respiratory Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Toby M', 'Initials': 'TM', 'LastName': 'Maher', 'Affiliation': 'Fibrosis Research Group, National Heart and Lung Institute, Imperial College, London, UK. t.maher@rbht.nhs.uk.'}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'Wijsenbeek', 'Affiliation': 'Department of Respiratory Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}]",Advances in therapy,['10.1007/s12325-019-01093-3']
1801,32429917,Reducing cardiometabolic risk in adults with a low socioeconomic position: protocol of the Supreme Nudge parallel cluster-randomised controlled supermarket trial.,"BACKGROUND


Unhealthy lifestyle behaviours such as unhealthy dietary intake and insufficient physical activity (PA) tend to cluster in adults with a low socioeconomic position (SEP), putting them at high cardiometabolic disease risk. Educational approaches aiming to improve lifestyle behaviours show limited effect in this population. Using environmental and context-specific interventions may create opportunities for sustainable behaviour change. In this study protocol, we describe the design of a real-life supermarket trial combining nudging, pricing and a mobile PA app with the aim to improve lifestyle behaviours and lower cardiometabolic disease risk in adults with a low SEP.
METHODS


The Supreme Nudge trial includes nudging and pricing strategies cluster-randomised on the supermarket level, with: i) control group receiving no intervention; ii) group 1 receiving healthy food nudges (e.g., product placement or promotion); iii) group 2 receiving nudges and pricing strategies (taxing of unhealthy foods and subsidizing healthy foods). In collaboration with a Dutch supermarket chain we will select nine stores located in low SEP neighbourhoods, with the nearest competitor store at > 1 km distance and managed by a committed store manager. Across the clusters, a personalized mobile coaching app targeting walking behaviour will be randomised at the individual level, with: i) control group; ii) a group receiving the mobile PA app. All participants (target n = 1485) should be Dutch-speaking, aged 45-75 years with a low SEP and purchase more than half of their household grocery shopping at the selected supermarkets. Participants will be recruited via advertisements and mail-invitations followed by community-outreach methods. Primary outcomes are changes in systolic blood pressure, LDL-cholesterol, HbA1c and dietary intake after 12 months follow-up. Secondary outcomes are changes in diastolic blood pressure, blood lipid markers, waist circumference, steps per day, and behavioural factors including healthy food purchasing, food decision style, social cognitive factors related to nudges and to walking behaviours and customer satisfaction after 12 months follow-up. The trial will be reflexively monitored to support current and future implementation.
DISCUSSION


The findings can guide future research and public health policies on reducing lifestyle-related health inequalities, and contribute to a supermarket-based health promotion intervention implementation roadmap.
TRIAL REGISTRATION


Dutch Trial Register ID NL7064, 30th of May, 2018.",2020,"Primary outcomes are changes in systolic blood pressure, LDL-cholesterol, HbA1c and dietary intake after 12 months follow-up.","['adults with a low socioeconomic position', 'The Supreme Nudge trial includes nudging and pricing strategies cluster-randomised on the supermarket level, with: i', 'adults with a low SEP', 'All participants (target n\xa0=\u20091485) should be Dutch-speaking, aged 45-75\u2009years with a low SEP and purchase more than half of their household grocery shopping at the selected supermarkets', 'Participants will be recruited via advertisements and mail-invitations followed by community-outreach methods', 'adults with a low socioeconomic position (SEP), putting them at high cardiometabolic disease risk']","['control group receiving no intervention; ii) group 1 receiving healthy food nudges (e.g., product placement or promotion); iii) group 2 receiving nudges and pricing strategies (taxing of unhealthy foods and subsidizing healthy foods']","['changes in systolic blood pressure, LDL-cholesterol, HbA1c and dietary intake', 'changes in diastolic blood pressure, blood lipid markers, waist circumference, steps per day, and behavioural factors including healthy food purchasing, food decision style, social cognitive factors related to nudges and to walking behaviours and customer satisfaction', 'cardiometabolic risk', 'lifestyle behaviours']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C3282376', 'cui_str': 'Supreme'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033118', 'cui_str': 'Pricing'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0557778', 'cui_str': 'Supermarket'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0150768', 'cui_str': 'Shopping'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0282110', 'cui_str': 'Community Outreach'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1281905', 'cui_str': 'At risk of disease'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0033118', 'cui_str': 'Pricing'}, {'cui': 'C0039371', 'cui_str': 'Tax'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009827', 'cui_str': 'Consumer Satisfaction'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]",,0.122374,"Primary outcomes are changes in systolic blood pressure, LDL-cholesterol, HbA1c and dietary intake after 12 months follow-up.","[{'ForeName': 'Josine M', 'Initials': 'JM', 'LastName': 'Stuber', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam Public Health research institute, Amsterdam UMC, VU University Amsterdam, Amsterdam, the Netherlands. j.stuber@amsterdamumc.nl.'}, {'ForeName': 'Joreintje D', 'Initials': 'JD', 'LastName': 'Mackenbach', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam Public Health research institute, Amsterdam UMC, VU University Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Femke E', 'Initials': 'FE', 'LastName': 'de Boer', 'Affiliation': 'Department of Social, Health and Organizational Psychology, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Gert-Jan', 'Initials': 'GJ', 'LastName': 'de Bruijn', 'Affiliation': 'Amsterdam School of Communication Research ASCoR, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Gillebaart', 'Affiliation': 'Department of Social, Health and Organizational Psychology, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Marjolein C', 'Initials': 'MC', 'LastName': 'Harbers', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Jody C', 'Initials': 'JC', 'LastName': 'Hoenink', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam Public Health research institute, Amsterdam UMC, VU University Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Michel C A', 'Initials': 'MCA', 'LastName': 'Klein', 'Affiliation': 'Social AI group, department of Computer Science, VU University Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Cédric N H', 'Initials': 'CNH', 'LastName': 'Middel', 'Affiliation': 'Athena Institute, Faculty of Science, VU University, Amsterdam, The Netherlands.'}, {'ForeName': 'Yvonne T', 'Initials': 'YT', 'LastName': 'van der Schouw', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Tjerk Jan', 'Initials': 'TJ', 'LastName': 'Schuitmaker-Warnaar', 'Affiliation': 'Athena Institute, Faculty of Science, VU University, Amsterdam, The Netherlands.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Velema', 'Affiliation': 'Netherlands Nutrition Centre (Voedingscentrum), The Hague, The Netherlands.'}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Vos', 'Affiliation': 'Amsterdam School of Communication Research ASCoR, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Wilma E', 'Initials': 'WE', 'LastName': 'Waterlander', 'Affiliation': 'Department of Public Health, Amsterdam Public Health research institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Lakerveld', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam Public Health research institute, Amsterdam UMC, VU University Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Joline W J', 'Initials': 'JWJ', 'LastName': 'Beulens', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam Public Health research institute, Amsterdam UMC, VU University Amsterdam, Amsterdam, the Netherlands.'}]",Nutrition journal,['10.1186/s12937-020-00562-8']
1802,31422671,Omega-3 Fatty Acids for the Management of Hypertriglyceridemia: A Science Advisory From the American Heart Association.,"Hypertriglyceridemia (triglycerides 200-499 mg/dL) is relatively common in the United States, whereas more severe triglyceride elevations (very high triglycerides, ≥500 mg/dL) are far less frequently observed. Both are becoming increasingly prevalent in the United States and elsewhere, likely driven in large part by growing rates of obesity and diabetes mellitus. In a 2002 American Heart Association scientific statement, the omega-3 fatty acids (n-3 FAs) eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) were recommended (at a dose of 2-4 g/d) for reducing triglycerides in patients with elevated triglycerides. Since 2002, prescription agents containing EPA+DHA or EPA alone have been approved by the US Food and Drug Administration for treating very high triglycerides; these agents are also widely used for hypertriglyceridemia. The purpose of this advisory is to summarize the lipid and lipoprotein effects resulting from pharmacological doses of n-3 FAs (>3 g/d total EPA+DHA) on the basis of new scientific data and availability of n-3 FA agents. In treatment of very high triglycerides with 4 g/d, EPA+DHA agents reduce triglycerides by ≥30% with concurrent increases in low-density lipoprotein cholesterol, whereas EPA-only did not raise low-density lipoprotein cholesterol in very high triglycerides. When used to treat hypertriglyceridemia, n-3 FAs with EPA+DHA or with EPA-only appear roughly comparable for triglyceride lowering and do not increase low-density lipoprotein cholesterol when used as monotherapy or in combination with a statin. In the largest trials of 4 g/d prescription n-3 FA, non-high-density lipoprotein cholesterol and apolipoprotein B were modestly decreased, indicating reductions in total atherogenic lipoproteins. The use of n-3 FA (4 g/d) for improving atherosclerotic cardiovascular disease risk in patients with hypertriglyceridemia is supported by a 25% reduction in major adverse cardiovascular events in REDUCE-IT (Reduction of Cardiovascular Events With EPA Intervention Trial), a randomized placebo-controlled trial of EPA-only in high-risk patients treated with a statin. The results of a trial of 4 g/d prescription EPA+DHA in hypertriglyceridemia are anticipated in 2020. We conclude that prescription n-3 FAs (EPA+DHA or EPA-only) at a dose of 4 g/d (>3 g/d total EPA+DHA) are an effective and safe option for reducing triglycerides as monotherapy or as an adjunct to other lipid-lowering agents.",2019,The use of n-3 FA (4 g/d) for improving atherosclerotic cardiovascular disease risk in patients with hypertriglyceridemia is supported by a 25% reduction in major adverse cardiovascular events in REDUCE-IT (Reduction of Cardiovascular Events,"['patients with elevated triglycerides', 'patients with hypertriglyceridemia', 'high-risk patients treated with a statin']","['n-3 FA agents', 'n-3 FAs', 'placebo', 'prescription n-3 FAs (EPA+DHA or EPA', 'n-3 FA', 'omega-3 fatty acids (n-3 FAs) eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA', 'Omega-3 Fatty Acids']","['low-density lipoprotein cholesterol', 'density lipoprotein cholesterol and apolipoprotein B', 'total atherogenic lipoproteins', 'atherosclerotic cardiovascular disease risk', 'Hypertriglyceridemia', 'hypertriglyceridemia', 'severe triglyceride elevations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0360714', 'cui_str': 'Statins'}]","[{'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}]","[{'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0065055', 'cui_str': 'lipoprotein cholesterol'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]",,0.0770584,The use of n-3 FA (4 g/d) for improving atherosclerotic cardiovascular disease risk in patients with hypertriglyceridemia is supported by a 25% reduction in major adverse cardiovascular events in REDUCE-IT (Reduction of Cardiovascular Events,"[{'ForeName': 'Ann C', 'Initials': 'AC', 'LastName': 'Skulas-Ray', 'Affiliation': ''}, {'ForeName': 'Peter W F', 'Initials': 'PWF', 'LastName': 'Wilson', 'Affiliation': ''}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Harris', 'Affiliation': ''}, {'ForeName': 'Eliot A', 'Initials': 'EA', 'LastName': 'Brinton', 'Affiliation': ''}, {'ForeName': 'Penny M', 'Initials': 'PM', 'LastName': 'Kris-Etherton', 'Affiliation': ''}, {'ForeName': 'Chesney K', 'Initials': 'CK', 'LastName': 'Richter', 'Affiliation': ''}, {'ForeName': 'Terry A', 'Initials': 'TA', 'LastName': 'Jacobson', 'Affiliation': ''}, {'ForeName': 'Mary B', 'Initials': 'MB', 'LastName': 'Engler', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': ''}, {'ForeName': 'Jennifer G', 'Initials': 'JG', 'LastName': 'Robinson', 'Affiliation': ''}, {'ForeName': 'Conrad B', 'Initials': 'CB', 'LastName': 'Blum', 'Affiliation': ''}, {'ForeName': 'Delfin', 'Initials': 'D', 'LastName': 'Rodriguez-Leyva', 'Affiliation': ''}, {'ForeName': 'Sarah D', 'Initials': 'SD', 'LastName': 'de Ferranti', 'Affiliation': ''}, {'ForeName': 'Francine K', 'Initials': 'FK', 'LastName': 'Welty', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIR.0000000000000709']
1803,31577038,"Placebo ""exercise drink"" study provides a welcome wake-up call about the importance of rigorous research.",,2020,,[],['Placebo'],[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.0563415,,"[{'ForeName': 'Örjan', 'Initials': 'Ö', 'LastName': 'Ekblom', 'Affiliation': 'Åstrand Laboratory of Work Physiology, Swedish School of Sport and Health Sciences, Stockholm, Sweden.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15009']
1804,31811645,Adjunctive use of enamel matrix derivatives to porcine-derived xenograft for the treatment of one-wall intrabony defects: 2-year longitudinal results of a randomized controlled clinical trial.,"BACKGROUND


The purpose of this study was to evaluate the potential advantages of adjunctive use of enamel matrix protein derivative (EMD) in combination with demineralized porcine bone matrix (DPBM) for the treatment of one-wall intrabony defects in the molar regions, in comparison with the use of DPBM alone, through a randomized controlled clinical trial.
METHODS


Forty-two participants were randomly assigned to two groups: one where DPBM with the adjunctive use of EMD (test group, n = 20) was applied and the other without EMD (control group, n = 22). Changes in the clinical and radiographic parameters from baseline at 6, 12, and 24 months were measured (probing pocket depth, clinical attachment loss, defect depth, and defect width). Postoperative discomfort (severity/duration of pain and swelling) and early soft tissue wound healing (dehiscence/fenestration, persistent swelling, spontaneous bleeding, and ulceration) were also assessed.
RESULTS


Both treatment modalities, with and without EMD, resulted in significant improvement of clinical and radiographic outcomes without any severe adverse events. However, no statistically significant differences in any of the measured parameters were found when the two groups were compared. Early wound healing outcomes and the severity of swelling did not differ between the groups, but the severity of pain (P = 0.046), duration (P = 0.033), and swelling (P = 0.022) were significantly lower in the test group.
CONCLUSIONS


DPBM has been verified for biocompatibility and can be used as a scaffold to enhance the clinical and radiographic outcomes of periodontal regeneration of one-wall intrabony defects. In particular, the adjunctive use of EMD significantly reduced the postoperative discomfort.",2019,"Both treatment modalities, with and without EMD, resulted in significant improvement of clinical and radiographic outcomes without any severe adverse events.",['Forty-two participants'],"['demineralized porcine bone matrix (DPBM', 'enamel matrix derivatives to porcine-derived xenograft', 'enamel matrix protein derivative (EMD', 'DPBM with the adjunctive use of EMD']","['severity of pain', 'Postoperative discomfort (severity/duration of pain and swelling) and early soft tissue wound healing (dehiscence/fenestration, persistent swelling, spontaneous bleeding, and ulceration', 'swelling', 'clinical attachment loss, defect depth, and defect width', 'clinical and radiographic outcomes', 'Early wound healing outcomes', 'postoperative discomfort', 'severity of swelling']","[{'cui': 'C4319566', 'cui_str': 'Forty-two'}]","[{'cui': 'C0005962', 'cui_str': 'Bone Matrix'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0522537', 'cui_str': 'Xenografts'}, {'cui': 'C0893442', 'cui_str': 'enamel matrix proteins'}, {'cui': 'C0340861', 'cui_str': 'PEA - Pulseless electrical activity'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C0043187', 'cui_str': 'Wind'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence (morphologic abnormality)'}, {'cui': 'C0337280', 'cui_str': 'Fenestration - action (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C3887532', 'cui_str': 'Ulceration (qualifier value)'}, {'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}]",42.0,0.0371864,"Both treatment modalities, with and without EMD, resulted in significant improvement of clinical and radiographic outcomes without any severe adverse events.","[{'ForeName': 'Jae-Hong', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Periodontology, Daejeon Dental Hospital, Institute of Wonkwang Dental Research, Wonkwang University College of Dentistry, Daejeon, Korea.'}, {'ForeName': 'Do-Hyung', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Department of Periodontology, Daejeon Dental Hospital, Institute of Wonkwang Dental Research, Wonkwang University College of Dentistry, Daejeon, Korea.'}, {'ForeName': 'Seong-Nyum', 'Initials': 'SN', 'LastName': 'Jeong', 'Affiliation': 'Department of Periodontology, Daejeon Dental Hospital, Institute of Wonkwang Dental Research, Wonkwang University College of Dentistry, Daejeon, Korea.'}]",Journal of periodontology,['10.1002/JPER.19-0432']
1805,32430896,Correction to: Endoscopic Argon Plasma Coagulation Vs. Multidisciplinary Evaluation in the Management of Weight Regain after Gastric Bypass Surgery: a Randomized Controlled Trial with SHAM Group.,In the original article the captions for Figs. 1-3 are incorrect.,2020,1-3 are incorrect.,['after Gastric Bypass Surgery'],"['SHAM', 'Endoscopic Argon Plasma Coagulation Vs']",['Weight Regain'],"[{'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C1879736', 'cui_str': 'Argon plasma coagulation'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}]",,0.102734,1-3 are incorrect.,"[{'ForeName': 'Luiz Gustavo', 'Initials': 'LG', 'LastName': 'de Quadros', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil. Gustavo_quadros@hotmail.com.'}, {'ForeName': 'Manoel Galvão', 'Initials': 'MG', 'LastName': 'Neto', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'João Caetano', 'Initials': 'JC', 'LastName': 'Marchesini', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Teixeira', 'Affiliation': 'Orlando Health Hospital, Orlando, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Grecco', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'Roberto Luiz Kaiser', 'Initials': 'RLK', 'LastName': 'Junior', 'Affiliation': 'Beneficência Portuguesa Hospital, Sao Jose do Rio Preto, São Paulo, Brazil.'}, {'ForeName': 'Natan', 'Initials': 'N', 'LastName': 'Zundel', 'Affiliation': 'Jackson North Medical Center, University at Buffalo, Miami, USA.'}, {'ForeName': 'Idiberto José Zotarelli', 'Initials': 'IJZ', 'LastName': 'Filho', 'Affiliation': 'Kaiser Day Hospital, Sao Jose do Rio Preto, São Paulo, Brazil.'}, {'ForeName': 'Thiago Ferreira', 'Initials': 'TF', 'LastName': 'de Souza', 'Affiliation': 'Hospital das Clínicas da Faculdade de Medicina, Universidade de São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Admar Concon', 'Initials': 'AC', 'LastName': 'Filho', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'Lyz Bezerra', 'Initials': 'LB', 'LastName': 'da Silva', 'Affiliation': 'Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Almino Cardoso', 'Initials': 'AC', 'LastName': 'Ramos', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'Álvaro Antônio Bandeira', 'Initials': 'ÁAB', 'LastName': 'Ferraz', 'Affiliation': 'Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Josemberg Marins', 'Initials': 'JM', 'LastName': 'Campos', 'Affiliation': 'Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}]",Obesity surgery,['10.1007/s11695-020-04478-4']
1806,32428059,Effect of violet LED light on in-office bleaching protocols: a randomized controlled clinical trial.,"Objective This study evaluated the clinical effect of violet LED light on in-office bleaching used alone or combined with 37% carbamide peroxide (CP) or 35% hydrogen peroxide (HP). Methodology A total of 100 patients were divided into five groups (n=20): LED, LED/CP, CP, LED/HP and HP. Colorimetric evaluation was performed using a spectrophotometer (ΔE, ΔL, Δa, Δb) and a visual shade guide (ΔSGU). Calcium (Ca)/phosphorous (P) ratio was quantified in the enamel microbiopsies. Measurements were performed at baseline (T 0 ), after bleaching (T B ) and in the 14-day follow-up (T 14 ). At each bleaching session, a visual scale determined the absolute risk (AR) and intensity of tooth sensitivity (TS). Data were evaluated by one-way (ΔE, Δa, ΔL, Δb), two-way repeated measures ANOVA (Ca/P ratio), and Tukey post-hoc tests. ΔSGU and TS were evaluated by Kruskal-Wallis and Mann-Whitney, and AR by Chi-Squared tests (a=5%). Results LED produced the lowest ΔE (p<0.05), but LED/HP promoted greater ΔE, ΔSGU and Δb (T 14 ) than HP (p<0.05). No differences were observed in ΔE and ΔSGU for LED/CP and HP groups (p>0.05). ΔL and Δa were not influenced by LED activation. After bleaching, LED/CP exhibited greater Δb than CP (p>0.05), but no differences were found between these groups at T 14 (p>0.05). LED treatment promoted the lowest risk of TS (16%), while HP promoted the highest (94.4%) (p<0.05). No statistical differences of risk of TS were found for CP (44%), LED/CP (61%) and LED/HP (88%) groups (p>0.05). No differences were found in enamel Ca/P ratio among treatments, regardless of evaluation times. Conclusions Violet LED alone produced the lowest bleaching effect, but enhanced HP bleaching results. Patients treated with LED/CP reached the same efficacy of HP, with reduced risk and intensity of tooth sensitivity and none of the bleaching protocols adversely affected enamel mineral content.",2020,"Results LED produced the lowest ΔE (p<0.05), but LED/HP promoted greater ΔE, ΔSGU and Δb (T 14 ) than HP (p<0.05).",['100 patients were divided into five groups (n=20'],"['LED/CP', 'LED, LED/CP, CP, LED/HP and HP', 'combined with 37% carbamide peroxide (CP) or 35% hydrogen peroxide (HP', 'violet LED light']","['risk of TS', 'enamel mineral content', 'lowest risk of TS', 'Calcium (Ca)/phosphorous (P) ratio', 'enamel Ca/P ratio', 'visual scale determined the absolute risk (AR) and intensity of tooth sensitivity (TS', 'efficacy of HP, with reduced risk and intensity of tooth sensitivity']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0108342', 'cui_str': 'carbamide peroxide'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0330463', 'cui_str': 'Viola'}, {'cui': 'C0023693', 'cui_str': 'Light'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}]",100.0,0.02735,"Results LED produced the lowest ΔE (p<0.05), but LED/HP promoted greater ΔE, ΔSGU and Δb (T 14 ) than HP (p<0.05).","[{'ForeName': 'Matheus', 'Initials': 'M', 'LastName': 'Kury', 'Affiliation': 'Departamento de Odontologia Restauradora, Faculdade de Odontologia de Piracicaba, Universidade Estadual de Campinas, Piracicaba, SP, Brasil.'}, {'ForeName': 'Erica Eiko', 'Initials': 'EE', 'LastName': 'Wada', 'Affiliation': 'Departamento de Odontologia Restauradora, Faculdade de Odontologia de Piracicaba, Universidade Estadual de Campinas, Piracicaba, SP, Brasil.'}, {'ForeName': 'Daylana Pacheco da', 'Initials': 'DPD', 'LastName': 'Silva', 'Affiliation': 'Departamento de Odontologia Restauradora, Faculdade de Odontologia de Piracicaba, Universidade Estadual de Campinas, Piracicaba, SP, Brasil.'}, {'ForeName': 'Cínthia Pereira Machado', 'Initials': 'CPM', 'LastName': 'Tabchoury', 'Affiliation': 'Departamento de Ciências Fisiológicas, Faculdade de Odontologia de Piracicaba, Universidade Estadual de Campinas, Piracicaba, SP, Brasil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Giannini', 'Affiliation': 'Departamento de Odontologia Restauradora, Faculdade de Odontologia de Piracicaba, Universidade Estadual de Campinas, Piracicaba, SP, Brasil.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Cavalli', 'Affiliation': 'Departamento de Odontologia Restauradora, Faculdade de Odontologia de Piracicaba, Universidade Estadual de Campinas, Piracicaba, SP, Brasil.'}]",Journal of applied oral science : revista FOB,['10.1590/1678-7757-2019-0720']
1807,31654434,In response to Dexmedetomidine versus propofol at different sedation depths during drug-induced sleep endoscopy: A randomized trial.,,2020,,[],"['propofol', 'Dexmedetomidine']",[],[],"[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]",[],,0.0283193,,"[{'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Jain', 'Affiliation': 'Department of Anesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Tonsy', 'Initials': 'T', 'LastName': 'Pandiyara', 'Affiliation': 'Department of Anesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Komal', 'Initials': 'K', 'LastName': 'Gandhi', 'Affiliation': 'Department of Anesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Arora', 'Affiliation': 'Department of Anesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Bansal', 'Affiliation': 'Department of Otolaryngology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}]",The Laryngoscope,['10.1002/lary.28363']
1808,31434507,"Ezetimibe Lipid-Lowering Trial on Prevention of Atherosclerotic Cardiovascular Disease in 75 or Older (EWTOPIA 75): A Randomized, Controlled Trial.","BACKGROUND


Evidence regarding the primary prevention of coronary artery disease events by low-density lipoprotein cholesterol (LDL-C) lowering therapy in older individuals, aged ≥75 years, is insufficient. This trial tested whether LDL-C-lowering therapy with ezetimibe is useful for the primary prevention of cardiovascular events in older patients.
METHODS


This multicenter, prospective, randomized, open-label, blinded end-point evaluation conducted at 363 medical institutions in Japan examined the preventive efficacy of ezetimibe for patients aged ≥75 years, with elevated LDL-C without history of coronary artery disease. Patients, who all received dietary counseling, were randomly assigned (1:1) to receive ezetimibe (10 mg once daily) versus usual care with randomization stratified by site, age, sex, and baseline LDL-C. The primary outcome was a composite of sudden cardiac death, myocardial infarction, coronary revascularization, or stroke.
RESULTS


Overall, 3796 patients were enrolled between May 2009 and December 2014, and 1898 each were randomly assigned to ezetimibe versus control. Median follow-up was 4.1 years. After exclusion of 182 ezetimibe patients and 203 control patients because of lack of appropriate informed consent and other protocol violations, 1716 (90.4%) and 1695 (89.3%) patients were included in the primary analysis, respectively. Ezetimibe reduced the incidence of the primary outcome (hazard ratio [HR], 0.66; 95% CI, 0.50-0.86;  P =0.002). Regarding the secondary outcomes, the incidences of composite cardiac events (HR, 0.60; 95% CI, 0.37-0.98;  P =0.039) and coronary revascularization (HR, 0.38; 95% CI, 0.18-0.79;  P =0.007) were lower in the ezetimibe group than in the control group; however, there was no difference in the incidence of stroke, all-cause mortality, or adverse events between trial groups.
CONCLUSIONS


LDL-C-lowering therapy with ezetimibe prevented cardiovascular events, suggesting the importance of LDL-C lowering for primary prevention in individuals aged ≥75 years with elevated LDL-C. Given the open-label nature of the trial, its premature termination and issues with follow-up, the magnitude of benefit observed should be interpreted with caution. Clinical Registration: URL: https://www.umin.ac.jp. Unique identifier: UMIN000001988.",2019,"Ezetimibe reduced the incidence of the primary outcome (hazard ratio [HR], 0.66; 95% confidence interval [CI], 0.50-0.86; P=0.002).","['older individuals aged ≥75 years', '363 medical institutions in Japan', '3,796 patients were enrolled between May 2009 and December 2014, and 1,898 each', '75 or Older (EWTOPIA 75', 'older patients', 'individuals aged ≥75 years with elevated LDL-C', 'patients aged ≥75 years with elevated LDL-C without history of coronary artery disease', 'https://www.umin.ac.jp Unique identifier']","['Ezetimibe', 'LDL-C-lowering therapy with ezetimibe', 'dietary counseling', 'Ezetimibe Lipid-Lowering Trial', 'ezetimibe', 'ezetimibe versus control', 'LDL-C-lowering therapy']","['coronary revascularization', 'incidences of composite cardiac events', 'incidence of stroke, all-cause mortality, or adverse events', 'cardiovascular events', 'composite of sudden cardiac death, myocardial infarction, coronary revascularization, or stroke']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0085298', 'cui_str': 'Sudden Cardiac Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]",3796.0,0.28082,"Ezetimibe reduced the incidence of the primary outcome (hazard ratio [HR], 0.66; 95% confidence interval [CI], 0.50-0.86; P=0.002).","[{'ForeName': 'Yasuyoshi', 'Initials': 'Y', 'LastName': 'Ouchi', 'Affiliation': 'Toranomon Hospital, Tokyo, Japan (Y. Ouchi, M.K.).'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Sasaki', 'Affiliation': 'International University of Health and Welfare, Fukuoka, Japan (J.S.).'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Arai', 'Affiliation': 'National Center for Geriatrics and Gerontology, Obu, Japan (H.A.).'}, {'ForeName': 'Koutaro', 'Initials': 'K', 'LastName': 'Yokote', 'Affiliation': 'Chiba University, Chiba, Japan (K.Y.).'}, {'ForeName': 'Kazumasa', 'Initials': 'K', 'LastName': 'Harada', 'Affiliation': 'Tokyo Metropolitan Geriatric Hospital, Tokyo, Japan (K.H., H.I.).'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Katayama', 'Affiliation': 'General Tokyo Hospital, Tokyo, Japan (Y.K.).'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Urabe', 'Affiliation': 'Juntendo University Urayasu Hospital, Urayasu, Japan (T.U.).'}, {'ForeName': 'Yasufumi', 'Initials': 'Y', 'LastName': 'Uchida', 'Affiliation': 'Saga Memorial Hospital, Saga, Japan (Y.U.).'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Hayashi', 'Affiliation': 'Nagahama City Hospital, Nagahama, Japan (M.H.).'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Yokota', 'Affiliation': 'Yokota Clinic, Miyazaki, Japan (N.Y.).'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Nishida', 'Affiliation': 'Nishida Clinic, Neyagawa, Japan (H.N.).'}, {'ForeName': 'Takatoshi', 'Initials': 'T', 'LastName': 'Otonari', 'Affiliation': 'Otonari Clinic, Chikushino, Japan (T.O.).'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Arai', 'Affiliation': 'Arai Clinic, Yamagata, Japan (T.A.).'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Sakuma', 'Affiliation': 'Caress Sapporo Hokko Memorial Clinic, Sapporo, Japan (I.S.).'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Sakabe', 'Affiliation': 'Sakabe Clinic, Kyoto, Japan (K.S.).'}, {'ForeName': 'Masayasu', 'Initials': 'M', 'LastName': 'Yamamoto', 'Affiliation': 'Yamamoto Clinic, Shimoniikawa, Japan (M.Y.).'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kobayashi', 'Affiliation': 'Jyuzen General Hospital, Niihama, Japan (T.K.).'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Oikawa', 'Affiliation': 'Fukujuji Hospital, Tokyo, Japan (S.O.).'}, {'ForeName': 'Shizuya', 'Initials': 'S', 'LastName': 'Yamashita', 'Affiliation': 'Rinku General Medical Center, Izumisano, Japan (S.Y.).'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Rakugi', 'Affiliation': 'Osaka University, Suita, Japan (H.R.).'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Imai', 'Affiliation': 'Kyoto University, Japan (T.I., S.T.).'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Kyoto University, Japan (T.I., S.T.).'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Ohashi', 'Affiliation': 'Chuo University, Tokyo, Japan (Y. Osachi).'}, {'ForeName': 'Masanari', 'Initials': 'M', 'LastName': 'Kuwabara', 'Affiliation': 'Toranomon Hospital, Tokyo, Japan (Y. Ouchi, M.K.).'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Ito', 'Affiliation': 'Tokyo Metropolitan Geriatric Hospital, Tokyo, Japan (K.H., H.I.).'}]",Circulation,['10.1161/CIRCULATIONAHA.118.039415']
1809,32106835,Who can we reach and who can we keep? Predictors of intervention engagement and adherence in a cluster randomized controlled trial in South Africa.,"BACKGROUND


Engaging and retaining young men in community-based interventions is highly challenging. The purpose of this study was to investigate the individual factors that predict intervention engagement and adherence in a sample of at-risk South African men.
METHODS


Baseline data were collected as a part of a cluster randomised control trial (RCT) situated in Khayelitsha and Mfuleni, two peri-urban settlements situated on the outskirts of Cape Town, South Africa. Neighbourhoods were randomised to one of three intervention conditions. We performed univariate descriptive statistics to report neighbourhood and individual socio-demographic factors, and ran multivariate models, adjusting for entry of study, to determine if high adherence and consistency of engagement with the intervention were associated with socio-behavioural demographics and risk behaviours, such as hazardous substance use, gangsterism, and criminal activity.
RESULTS


Total of 729 men were on average 22.5 years old (SD 2.8), with a mean of 10 years of education. More than half of the sample were single (94%), lived with their parents (66%) and had an income below ~$30 (52%). The overall mean of adherence is 0.41 (SD 0.24) and mean of consistency of engagement is 0.61 (SD 0.30). Our data indicated that completing more years of education, living with parents, and having higher socioeconomic status were significantly associated with higher rates of engagement and adherence. Men with a history of gang membership demonstrated higher levels of adherence and consistent engagement with the intervention, compared with other men who were recruited to the intervention. Crucially, our data show that young men with a history of substance use, and young men who report symptoms of depression and high levels of perceived stress are equally likely as other young men to adhere to the intervention and attend intervention sessions consistently.
CONCLUSION


Our results may contribute to a better understanding of young men's patterns of engagement and adherence to public health interventions. The results may have important implications for policy and practice, as they may be useful in planning more effective interventions and could potentially be used to predict which young men can be reached through community-based interventions.
TRIAL REGISTRATION


ClinicalTrials.gov registration, NCT02358226. Prospectively registered 24 November 2014.",2020,"Men with a history of gang membership demonstrated higher levels of adherence and consistent engagement with the intervention, compared with other men who were recruited to the intervention.","['Baseline data were collected as a part of a cluster randomised control trial (RCT) situated in Khayelitsha and Mfuleni, two peri-urban settlements situated on the outskirts of Cape Town, South Africa', 'Prospectively registered 24 November 2014', 'sample of at-risk South African men', 'South Africa', 'Men with a history of gang membership', 'Total of 729 men were on average 22.5\u2009years old (SD 2.8), with a mean of 10\u2009years of education']",[],['overall mean of adherence'],"[{'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0453952', 'cui_str': 'Cape (physical object)'}, {'cui': 'C0557750', 'cui_str': 'Towns'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517649', 'cui_str': 'Twenty-two point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",729.0,0.0713061,"Men with a history of gang membership demonstrated higher levels of adherence and consistent engagement with the intervention, compared with other men who were recruited to the intervention.","[{'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Rabie', 'Affiliation': 'Institute for Life Course Health Research, Department of Global Health, Stellenbosch University, P O Box 241, Cape Town, 8000, South Africa. srabie@sun.ac.za.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Bantjes', 'Affiliation': 'Department of Psychology, Stellenbosch University, Private Bag X1, Matieland, 7602, South Africa.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gordon', 'Affiliation': 'Institute for Life Course Health Research, Department of Global Health, Stellenbosch University, P O Box 241, Cape Town, 8000, South Africa.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Almirol', 'Affiliation': 'Department of Psychiatry & Biobehavioral Sciences, Semel Institute, University of California Los Angeles, 10920 Wilshire Blvd., Suite 350, Los Angeles, California, 90024, USA.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Stewart', 'Affiliation': 'Institute for Life Course Health Research, Department of Global Health, Stellenbosch University, P O Box 241, Cape Town, 8000, South Africa.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tomlinson', 'Affiliation': 'Institute for Life Course Health Research, Department of Global Health, Stellenbosch University, P O Box 241, Cape Town, 8000, South Africa.'}, {'ForeName': 'Mary Jane', 'Initials': 'MJ', 'LastName': 'Rotheram-Borus', 'Affiliation': 'Department of Psychiatry & Biobehavioral Sciences, Semel Institute, University of California Los Angeles, 10920 Wilshire Blvd., Suite 350, Los Angeles, California, 90024, USA.'}]",BMC public health,['10.1186/s12889-020-8357-x']
1810,31809290,CORR Insights®: Combined Intravenous and Intraarticular Tranexamic Acid Does Not Offer Additional Benefit Compared with Intraarticular Use Alone in Bilateral TKA: A Randomized Controlled Trial.,,2020,,['Bilateral TKA'],['Intraarticular Tranexamic Acid'],[],"[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]",[],,0.186264,,"[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Grecula', 'Affiliation': 'M. J. Grecula, University of Texas Medical Branch, Department of Orthopaedic Surgery and Rehabilitation, Galveston, TX, USA.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001050']
1811,32428066,Effect of an interdisciplinary intervention with motivational approach on exercise capacity in obese adolescents: a randomized controlled clinical trial.,"Objective To evaluate the effect of an interdisciplinary intervention with a motivational approach on exercise capacity and usual physical activity levels in overweight and obese adolescents. Methods This is a randomized, controlled clinical trial with single blinding of subjects. Adolescents aged 15 to 18 years with overweight and obesity (body mass index ≥ 85 percentile) were included. The adolescents were randomized into two groups: interdisciplinary intervention or control - traditional approach aiming at lifestyle modifications. The initial evaluations were carried out, including the cardiopulmonary exercise test and the physical activity level measurement by using the International Physical Activity Questionnaire and a pedometer. The evaluations were performed in two moments: time zero (time of inclusion in the study) and after 3 months (end of intervention). There were 12 sessions with weekly meetings. Results A total of 37 participants were included, 19 in the Intervention Group. There were no significant differences in the baseline demographic, anthropometric and physical activity characteristics between groups, with mean age of 17.3±1.0 years in the Control Group, and 16.8±0.9 years in the Intervention Group (p=0.14). The motivational intervention did not cause significant differences (p>0.05) in the comparison of the variables of exercise capacity and usual physical activity (questionnaire and pedometer) between groups. Conclusion The intervention with a motivational approach did not alter exercise capacity and levels of usual physical activity in overweight and obese adolescents. Clinical Trial Registry: NCT02455973 and REBEC: RBR-234nb5.",2020,The motivational intervention did not cause significant differences (p>0.05) in the comparison of the variables of exercise capacity and usual physical activity (questionnaire and pedometer) between groups.,"['overweight and obese adolescents', 'subjects', 'Adolescents aged 15 to 18 years with overweight and obesity (body mass index ≥ 85 percentile', 'obese adolescents', 'A total of 37 participants were included, 19 in the Intervention Group']","['interdisciplinary intervention with a motivational approach', 'RBR-234nb5', 'interdisciplinary intervention or control - traditional approach aiming at lifestyle modifications', 'interdisciplinary intervention with motivational approach']","['exercise capacity and levels of usual physical activity', 'exercise capacity and usual physical activity levels', 'baseline demographic, anthropometric and physical activity characteristics', 'exercise capacity', 'exercise capacity and usual physical activity (questionnaire and pedometer']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",37.0,0.0502785,The motivational intervention did not cause significant differences (p>0.05) in the comparison of the variables of exercise capacity and usual physical activity (questionnaire and pedometer) between groups.,"[{'ForeName': 'Letiane Bueno', 'Initials': 'LB', 'LastName': 'Zanatta', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'João Paulo', 'Initials': 'JP', 'LastName': 'Heinzmann-Filho', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Fernanda Maria', 'Initials': 'FM', 'LastName': 'Vendrusculo', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Natália Evangelista', 'Initials': 'NE', 'LastName': 'Campos', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Margareth da Silva', 'Initials': 'MDS', 'LastName': 'Oliveira', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Ana Maria Pandolfo', 'Initials': 'AMP', 'LastName': 'Feoli', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Andréia da Silva', 'Initials': 'ADS', 'LastName': 'Gustavo', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Márcio Vinícius Fagundes', 'Initials': 'MVF', 'LastName': 'Donadio', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}]","Einstein (Sao Paulo, Brazil)",['10.31744/einstein_journal/2020ao5268']
1812,32428227,The role of the inferior parietal lobule in writer's cramp.,"Humans have a distinguishing ability for fine motor control that is subserved by a highly evolved cortico-motor neuronal network. The acquisition of a particular motor skill involves a long series of practice movements, trial and error, adjustment and refinement. At the cortical level, this acquisition begins in the parieto-temporal sensory regions and is subsequently consolidated and stratified in the premotor-motor cortex. Task-specific dystonia can be viewed as a corruption or loss of motor control confined to a single motor skill. Using a multimodal experimental approach combining neuroimaging and non-invasive brain stimulation, we explored interactions between the principal nodes of the fine motor control network in patients with writer's cramp and healthy matched controls. Patients and healthy volunteers underwent clinical assessment, diffusion-weighted MRI for tractography, and functional MRI during a finger tapping task. Activation maps from the task-functional MRI scans were used for target selection and neuro-navigation of the transcranial magnetic stimulation. Single- and double-pulse TMS evaluation included measurement of the input-output recruitment curve, cortical silent period, and amplitude of the motor evoked potentials conditioned by cortico-cortical interactions between premotor ventral (PMv)-motor cortex (M1), anterior inferior parietal lobule (aIPL)-M1, and dorsal inferior parietal lobule (dIPL)-M1 before and after inducing a long term depression-like plastic change to dIPL node with continuous theta-burst transcranial magnetic stimulation in a randomized, sham-controlled design. Baseline dIPL-M1 and aIPL-M1 cortico-cortical interactions were facilitatory and inhibitory, respectively, in healthy volunteers, whereas the interactions were converse and significantly different in writer's cramp. Baseline PMv-M1 interactions were inhibitory and similar between the groups. The dIPL-PMv resting state functional connectivity was increased in patients compared to controls, but no differences in structural connectivity between the nodes were observed. Cortical silent period was significantly prolonged in writer's cramp. Making a long term depression-like plastic change to dIPL node transformed the aIPL-M1 interaction to inhibitory (similar to healthy volunteers) and cancelled the PMv-M1 inhibition only in the writer's cramp group. These findings suggest that the parietal multimodal sensory association region could have an aberrant downstream influence on the fine motor control network in writer's cramp, which could be artificially restored to its normal function.",2020,"The dIPL-PMv resting state functional connectivity was increased in patients compared to controls, but no differences in structural connectivity between the nodes were observed.","[""patients with writer's cramp and healthy matched controls"", ""writer's cramp"", 'Patients and healthy volunteers', 'healthy volunteers']","['motor evoked potentials conditioned by cortico-cortical interactions between premotor ventral (PMv)-motor cortex (M1), anterior inferior parietal lobule (aIPL)-M1, and dorsal inferior parietal lobule (dIPL)-M1 before and after inducing a long term depression-like plastic change to dIPL node with continuous theta-burst transcranial magnetic stimulation', 'multimodal experimental approach combining neuroimaging and non-invasive brain stimulation', 'Single- and double-pulse TMS']","['structural connectivity', 'Baseline dIPL-M1 and aIPL-M1 cortico-cortical interactions', 'dIPL-PMv resting state functional connectivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0154676', 'cui_str': ""Organic writer's cramp""}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0152304', 'cui_str': 'Inferior parietal lobule structure'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0032167', 'cui_str': 'Plastic'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0679575', 'cui_str': 'Neuroimaging'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0870227', 'cui_str': 'Brain stimulation'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0232120', 'cui_str': 'Double pulse'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0340364', 'cui_str': 'Familial mitral valve prolapse'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.0317236,"The dIPL-PMv resting state functional connectivity was increased in patients compared to controls, but no differences in structural connectivity between the nodes were observed.","[{'ForeName': 'Shabbir Hussain I', 'Initials': 'SHI', 'LastName': 'Merchant', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Frangos', 'Affiliation': 'National Center for Complementary and Integrative Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Parker', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Bradson', 'Affiliation': 'National Center for Complementary and Integrative Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Tianxia', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Vial-Undurraga', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Leodori', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Bushnell', 'Affiliation': 'National Center for Complementary and Integrative Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Silvina G', 'Initials': 'SG', 'LastName': 'Horovitz', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hallett', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Traian', 'Initials': 'T', 'LastName': 'Popa', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}]",Brain : a journal of neurology,['10.1093/brain/awaa138']
1813,32432339,Time course of 75%-100% efficacy response of adjunctive brivaracetam.,"BACKGROUND


Time to sustained seizure frequency reduction can provide clinically meaningful epilepsy outcomes.
AIMS OF THE STUDY


To examine the time course of brivaracetam (BRV) efficacy in adults with focal seizures and focal to bilateral tonic-clonic seizures (FBTCS).
METHODS


Post hoc analysis of data pooled from three randomized controlled trials of oral adjunctive BRV in adults with epilepsy. Patients with focal epilepsy and a subpopulation with FBTCS receiving BRV 50, 100, or 200 mg/d (initiated without up-titration) or placebo for 12 weeks were analyzed for time to sustained ≥75%, ≥90%, and 100% seizure reduction without interruption from first day until trial ends.
RESULTS


Evaluation included 1160 patients with focal seizures, including 352 patients with FBTCS. Sustained ≥75%, ≥90%, and 100% response in focal seizures was higher from day 1 for BRV 100 and 200 mg/d vs placebo (P < .01). Sustained ≥75% and 100% FBTCS reduction from day 1 was higher for BRV 100 and 200-mg/d groups vs placebo (P < .01).
CONCLUSIONS


The majority of patients achieving 75%-100% sustained seizure frequency reduction (all focal seizure types and the subpopulation with FBTCS) with oral BRV (100 or 200 mg/d) achieved this response on the first-treatment day.",2020,"Sustained ≥75% and 100% FBTCS reduction from day 1 was higher for BRV 100 and 200-mg/d groups vs placebo (P <.01).
","['1160 patients with focal seizures, including 352 patients with FBTCS', 'Patients with focal epilepsy and a subpopulation with FBTCS receiving BRV 50, 100, or 200 mg/d (initiated without up-titration) or', 'adults with focal seizures and focal to bilateral tonic-clonic seizures (FBTCS', 'adults with epilepsy']","['oral adjunctive BRV', 'adjunctive brivaracetam', 'oral BRV', 'placebo']","['focal seizures', 'time course of brivaracetam (BRV) efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0494475', 'cui_str': 'Tonic-clonic seizure'}, {'cui': 'C0014547', 'cui_str': 'Localization-related epilepsy'}, {'cui': 'C1257890', 'cui_str': 'Group'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0449247', 'cui_str': 'Time course'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",1160.0,0.262434,"Sustained ≥75% and 100% FBTCS reduction from day 1 was higher for BRV 100 and 200-mg/d groups vs placebo (P <.01).
","[{'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Klein', 'Affiliation': 'Mid-Atlantic Epilepsy and Sleep Center, Bethesda, MD, USA.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Laloyaux', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Elmoufti', 'Affiliation': 'UCB Pharma, Raleigh, NC, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Gasalla', 'Affiliation': 'UCB Pharma, Raleigh, NC, USA.'}, {'ForeName': 'Melinda S', 'Initials': 'MS', 'LastName': 'Martin', 'Affiliation': 'UCB Pharma, Smyrna, GA, USA.'}]",Acta neurologica Scandinavica,['10.1111/ane.13287']
1814,32432356,Comment on: Comparison of the duration of hospital stay after laparoscopic or open distal pancreatectomy: randomized controlled trial.,,2020,,[],['laparoscopic or open distal pancreatectomy'],['hospital stay'],[],"[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0176940', 'cui_str': 'Distal subtotal pancreatectomy'}]","[{'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",,0.113769,,"[{'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Hu', 'Affiliation': 'Department of General Surgery, Tongde\u2009Hospital\u2009of\u2009Zhejiang\u2009Province, Hangzhou, China.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Wu', 'Affiliation': 'Department of General Surgery, Tongde\u2009Hospital\u2009of\u2009Zhejiang\u2009Province, Hangzhou, China.'}]",The British journal of surgery,['10.1002/bjs.11680']
1815,32106837,Can the prophylactic quadrivalent HPV vaccine be used as a therapeutic agent in women with CIN? A randomized trial.,"BACKGROUND


Human papillomavirus (HPV) is one of the most significant risk factors for cervical cancer. The HPV vaccine has a very significant impact on the incidence of cervical cancer. The present study aimed to investigate the impact of prophylactic quadrivalent HPV vaccine in the treatment of women with cervical intraepithelial neoplasia (CIN 1-3).
METHODS


This randomized controlled trial was conducted in the Shahid Sadoughi University of Medical Sciences (SSUMS), Yazd, Iran, from October 2011 to November 2015 in women with histologically confirmed residual/recurrent CIN 1 or high-grade CIN (CIN 2-3). Eligible women were assigned randomly to an intervention and a control group. Women in the intervention group were given HPV vaccinations while those in the control group were not. Participants were followed up for 24 months. Primary and secondary outcomes, and adverse effects of the treatment in the two groups were compared using Student's t test, the chi-square test, or Fisher's exact test. P values < 0.05 or less were considered statistically significant.
RESULTS


Three-hundred and twelve women were randomized to the two groups; the data of 138 in the intervention group and 104 in the control group were analyzed. The mean age of the women was 32.59 ± 4.85 years. Differences in age, marital status, and grades of CIN weren't significant between the two groups. At the end of the two-year follow-up period, the number of women with CIN 2-3 in the intervention and control groups was reduced by 75% (from 93 to 23) versus 40% (from 69 to 41). The efficacy of the HPV vaccine in women with CIN 1-3 was 58.7% (p = 0.018). No serious adverse effects related to the vaccines were reported.
CONCLUSIONS


The prophylactic quadrivalent HPV vaccine after treatment may have a therapeutic effect in women with residual/recurrent CIN 1 or high-grade CIN (CIN 2-3).
TRIAL REGISTRATION


Iranian Registry of Clinical Trials, IRCT20190603043801N1. Registered 24 July 2019 - Retrospectively registered, http://www.irct.ir/user/trial/40017/view.",2020,"The prophylactic quadrivalent HPV vaccine after treatment may have a therapeutic effect in women with residual/recurrent CIN 1 or high-grade CIN (CIN 2-3).
","['Shahid Sadoughi University of Medical Sciences (SSUMS), Yazd, Iran, from October 2011 to November 2015 in women with histologically confirmed residual/recurrent CIN 1 or high-grade CIN (CIN 2-3', 'women with residual/recurrent CIN 1 or high-grade CIN (CIN 2-3', 'women with CIN', 'Registered 24 July 2019 - Retrospectively registered, http://www.irct.ir/user/trial/40017/view', 'The mean age of the women was 32.59\u2009±\u20094.85\u2009years', 'Eligible women', 'Three-hundred and twelve women', 'women with cervical intraepithelial neoplasia (CIN 1-3']","['HPV vaccine', 'prophylactic quadrivalent HPV vaccine', 'HPV vaccinations']",['adverse effects'],"[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517706', 'cui_str': '312 (qualifier value)'}, {'cui': 'C0206708', 'cui_str': 'Cervical Intraepithelial Neoplasms'}]","[{'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}]",312.0,0.117944,"The prophylactic quadrivalent HPV vaccine after treatment may have a therapeutic effect in women with residual/recurrent CIN 1 or high-grade CIN (CIN 2-3).
","[{'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Karimi-Zarchi', 'Affiliation': 'Endometriosis Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Allahqoli', 'Affiliation': 'Endometriosis Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Ameneh', 'Initials': 'A', 'LastName': 'Nehmati', 'Affiliation': 'Islamic Azad University, Yazd Branch, Yazd, Iran.'}, {'ForeName': 'Abolfazl Mehdizadeh', 'Initials': 'AM', 'LastName': 'Kashi', 'Affiliation': 'Endometriosis Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Shokouh', 'Initials': 'S', 'LastName': 'Taghipour-Zahir', 'Affiliation': 'Shahid Sadoughi University of Medical Science, Yazd, Iran.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Alkatout', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospitals Schleswig-Holstein, Campus Kiel, Kiel, Germany. Ibrahim.Alkatout@uksh.de.'}]",BMC public health,['10.1186/s12889-020-8371-z']
1816,31800558,"Letter to the Editor Following ""Prospective Clinical Trial Comparing Outcome Measures Between Furlow and von Langenbeck Palatoplasties for UCLP"" by William N. Williams, M. Brent Seagle, Maria Ines Pegoraro-Krook, et al. Annals of Plastic Surgery, 2011.",,2020,,[],[],"['Furlow and von Langenbeck Palatoplasties for UCLP"" by William N. Williams, M. Brent Seagle, Maria Ines Pegoraro-Krook, et al']",[],[],[],,0.0242814,,"[{'ForeName': 'Qingshu', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': ""Singapore Clinical Research Institute, Singapore qingshu.lu@scri.edu.sg Department of Plastic, Reconstructive, and Aesthetic Surgery, Singapore General Hospital, Singapore. Cleft and Craniofacial Centre, KK Women's and Children Hospital, Singapore. SingHealth Duke-NUS Academic Medical Centre, Singapore. Leicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom.""}, {'ForeName': 'Seng Teik', 'Initials': 'ST', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Selena Ee-Li', 'Initials': 'SE', 'LastName': 'Young', 'Affiliation': ''}, {'ForeName': 'Say Beng', 'Initials': 'SB', 'LastName': 'Tan', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Machin', 'Affiliation': ''}]",Annals of plastic surgery,['10.1097/SAP.0000000000002078']
1817,31987566,Geotherapy combined with kinesiotherapy is efficient in reducing pain in patients with osteoarthritis.,"INTRODUCTION


Patients with osteoarthritis (OA) suffer from a degenerative disease that causes several physical disabilities and pain. Despite the few studies involving exercise combined with geotherapy (a therapy using poultices made from earth materials such as clay or mud) for patients with OA, this subject is still under debate, as effect of the earth material remains unclear. The aim of this study was to compare pain, joint stiffness and disability in patients who underwent kinesiotherapy (K) or geotherapy combined with kinesiotherapy (GK).
METHOD


This was a clinical randomized single-blinded prospective study, in which 48 individuals participated. Volunteers were evaluated for pain perception, pressure pain tolerance thresholds, and responded to questionnaires about pain, joint stiffness and physical disability (WOMAC) and about symptoms and disability (Lequesne Algofunctional Index). Patients in K group underwent 15 twice-weekly sessions of kinesiotherapy consisting of stretching and strengthening exercises for lower limbs. GK patients received a poultice of powder dolomite mixed with hot water on the knees for 25 min before each of the 15 sessions of the same kinesiotherapy program.
RESULTS


Both interventions were effective in reducing pain, joint stiffness and physical disability (p < 0.001), and in increasing pressure pain thresholds (p < 0.05); however, patients who underwent GK presented a more pronounced reduction in pain perception (p = 0.006) than those in K group. They also exhibited more tolerance to pain in all sites evaluated.
CONCLUSION


Both interventions were effective in reducing pain, joint stiffness and physical disability, but GK produced significantly better results in pain perception.",2020,"Both interventions were effective in reducing pain, joint stiffness and physical disability, but GK produced significantly better results in pain perception.","['48 individuals participated', 'patients who underwent kinesiotherapy (K) or geotherapy combined with kinesiotherapy (GK', 'patients with osteoarthritis', 'Patients with osteoarthritis (OA) suffer from a degenerative disease that causes several physical disabilities and pain']","['exercise combined with geotherapy', 'Geotherapy combined with kinesiotherapy', 'kinesiotherapy consisting of stretching and strengthening exercises']","['tolerance to pain', 'pain perception', 'pain, joint stiffness and disability', 'pain perception, pressure pain tolerance thresholds, and responded to questionnaires about pain, joint stiffness and physical disability (WOMAC) and about symptoms and disability (Lequesne Algofunctional Index', 'pain', 'pressure pain thresholds', 'pain, joint stiffness and physical disability']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1096702', 'cui_str': 'Kinesiotherapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1096702', 'cui_str': 'Kinesiotherapy'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise (regime/therapy)'}]","[{'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C0162298', 'cui_str': 'Joint stiffness (finding)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",48.0,0.0263814,"Both interventions were effective in reducing pain, joint stiffness and physical disability, but GK produced significantly better results in pain perception.","[{'ForeName': 'Fabio Marcon', 'Initials': 'FM', 'LastName': 'Alfieri', 'Affiliation': ""Master's Program in Health Promotion and Physical Therapy Undergraduation, Adventist University of Sao Paulo (UNASP), Brazil.""}, {'ForeName': 'Maria Carolina Cabral', 'Initials': 'MCC', 'LastName': 'Barros', 'Affiliation': 'Adventist University of Sao Paulo (UNASP), Brazil.'}, {'ForeName': 'Katia Cristina de', 'Initials': 'KC', 'LastName': 'Carvalho', 'Affiliation': 'Adventist University of Sao Paulo (UNASP), Brazil.'}, {'ForeName': 'Isabelly', 'Initials': 'I', 'LastName': 'Toral', 'Affiliation': 'Adventist University of Sao Paulo (UNASP), Brazil.'}, {'ForeName': 'Cristina Fontoura da', 'Initials': 'CFD', 'LastName': 'Silva', 'Affiliation': 'Adventist University of Sao Paulo (UNASP), Brazil.'}, {'ForeName': 'Natalia Cristina de Oliveira', 'Initials': 'NCO', 'LastName': 'Vargas E Silva', 'Affiliation': ""Master's Program in Health Promotion, Physical Therapy and Physical Education Undergraduation, Adventist University of Sao Paulo (UNASP), Brazil. Electronic address: natalia.silva@unasp.edu.br.""}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.05.032']
1818,18427971,Adolescent sexual risk: factors predicting condom use across the stages of change.,"This study examined factors associated with high-risk adolescents' movement toward or away from adopting consistent condom use behavior using the Transtheoretical Model Stages of Change. Participants drawn from the inactive comparison condition of a randomized HIV prevention trial (Project SHIELD) responded to items assessing pros and cons of condom use, peer norms, condom communication, and perceived invulnerability to HIV. Participants were categorized based on their condom use behavior using the Transtheoretical Model. Multiple logistic regressions found that progression to consistent condom use was predicted by continuing to perceive more advantages to condom use, reporting greater condom use communication with partners, and less perceived invulnerability to HIV. Movement away from adopting consistent condom use was predicted by a decrease in perceived advantages to condom use, increased perceived condom disadvantages, and fewer condom discussions. Future interventions may be tailored to enhance these factors that were found to change over time.",2008,"Movement away from adopting consistent condom use was predicted by a decrease in perceived advantages to condom use, increased perceived condom disadvantages, and fewer condom discussions.",['Adolescent sexual risk'],[],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",[],[],,0.0235298,"Movement away from adopting consistent condom use was predicted by a decrease in perceived advantages to condom use, increased perceived condom disadvantages, and fewer condom discussions.","[{'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Grossman', 'Affiliation': 'National Institute of Mental Health, 6001 Executive Blvd., Bethesda, MD 20892, USA. grossmanc@mail.nih.gov'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Hadley', 'Affiliation': ''}, {'ForeName': 'Larry K', 'Initials': 'LK', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Houck', 'Affiliation': ''}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Peters', 'Affiliation': ''}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Tolou-Shams', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",AIDS and behavior,['10.1007/s10461-008-9396-y']
1819,32432411,Treatment With Mycophenolate and Cyclophosphamide Leads to Clinically Meaningful Improvements in Patient-Reported Outcomes in Scleroderma Lung Disease: Results of Scleroderma Lung Study II.,"OBJECTIVE


Our objective was to determine if treatment with cyclophosphamide (CYC) and mycophenolate mofetil (MMF) improves patient-reported outcomes (PROs) among patients with systemic sclerosis-related interstitial lung disease (SSc-ILD).
METHODS


This study examined PROs in patients with SSc-ILD (N = 142) who participated in the Scleroderma Lung Study II, a randomized controlled trial comparing MMF for 2 years with oral CYC for 1 year followed by 1 year of a placebo. Joint models were created to evaluate the course of PROs over 2 years. The difference in PRO scores from baseline to 24 months was measured, and the percentage of patients meeting the minimum clinically important difference (MCID) was calculated. Correlations between PROs and SSc-ILD disease severity measures were also examined.
RESULTS


Treatment with CYC and MMF led to improvements in several PROs with no between-treatment differences. Scores for the Transitional Dyspnea Index (TDI) and St. George's Respiratory Questionnaire (SGRQ) improved significantly over 2 years, and 29%/24% and 28%/25% of participants in the CYC/MMF groups met or exceeded the MCID estimates for TDI and SGRQ, respectively. At baseline, the forced vital capacity (FVC) percentage predicted (FVC%-predicted) did not correlate with the Baseline Dyspnea Index or SGRQ. However, improvements in the FVC%-predicted were weakly associated with improvements in dyspnea (assessed by the TDI) and SGRQ scores.
CONCLUSION


Treatment with CYC and MMF improved overall health-related quality of life in patients with SSc-ILD. The relationship between PRO measures and the FVC was relatively weak, suggesting that PROs provide complementary information about treatment efficacy not captured by changes in the FVC alone in this patient population.",2020,"At baseline, the forced vital capacity (FVC) percentage predicted (FVC%-predicted) did not correlate with the Baseline Dyspnea Index or SGRQ.","['patients with SSc-ILD', 'patients with SSc-ILD (N = 142) who participated in the Scleroderma Lung Study II', 'patients with systemic sclerosis-related interstitial lung disease (SSc-ILD']","['oral CYC', 'Mycophenolate and Cyclophosphamide', 'cyclophosphamide (CYC) and mycophenolate mofetil (MMF', 'CYC and MMF', 'MMF', 'placebo']","['overall health-related quality of life', 'dyspnea (assessed by the TDI) and SGRQ scores', 'several PROs', 'PRO scores', ""Transitional Dyspnea Index (TDI) and St. George's Respiratory Questionnaire (SGRQ"", 'Baseline Dyspnea Index or SGRQ', 'forced vital capacity (FVC) percentage predicted (FVC%-predicted']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3472502', 'cui_str': ""Saint George's respiratory questionnaire score""}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0442732', 'cui_str': 'Vital'}]",142.0,0.0648355,"At baseline, the forced vital capacity (FVC) percentage predicted (FVC%-predicted) did not correlate with the Baseline Dyspnea Index or SGRQ.","[{'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Volkmann', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Donald P', 'Initials': 'DP', 'LastName': 'Tashkin', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'LeClair', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Roth', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Kim', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Goldin', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Clements', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Furst', 'Affiliation': 'University of California, Los Angeles, University of Washington, Seattle, and University of Florence, Florence, Italy.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Khanna', 'Affiliation': 'University of Michigan Medical School, Ann Arbor.'}]",ACR open rheumatology,['10.1002/acr2.11125']
1820,18551124,Insulin use and weight maintenance in well-controlled type 2 diabetes: a prospective cohort study.,"Intensification of glycemic control is associated with weight gain, however, less is known about weight change during the maintenance phase of glycemic management. On the basis of current models of energy homeostasis, we hypothesize that insulin use will result in less weight gain than oral antidiabetic agents in patients with well-controlled diabetes. This is a prospective cohort nested within a randomized control trial at an academic clinic, with enrollment from June 2002 to January 2005. A total of 163 patients with type 2 diabetes were enrolled after obtaining glycemic control. Insulin use was assessed by self-report at baseline. Participants were weighed at baseline and five follow-up visits over 24 months. The weight change was compared between insulin users and noninsulin users. The average (s.d.) age was 55 (11), 44% are female and 21% are black. The median duration of diabetes was 5 (0.5-10) years. At baseline, 88 participants (54%) reported insulin use with an average of 69 (6) units/day. Baseline BMI in the insulin users was 35 (6) and 33 (6) in noninsulin patients. Over 24 months, noninsulin patients gained 2.3 additional kilograms compared with insulin users (2.8 kg (6.8) vs. 0.5 kg (6.5), P = 0.065). After adjusting for age, race, sex, baseline weight, intervention status, and change in A1C, insulin users had 2.5 kg less weight gain than noninsulin users (P = 0.033). Less weight gain was observed over 24 months in insulin-treated patients. Whether this effect may be due to central catabolic effects of insulin merits additional confirmatory study and mechanistic investigation.",2008,"At baseline, 88 participants (54%) reported insulin use with an average of 69 (6) units/day.","['patients with well-controlled diabetes', 'age was 55 (11), 44% are female and 21% are black', '2 diabetes', '163 patients with type 2 diabetes were enrolled after obtaining glycemic control', 'academic clinic, with enrollment from June 2002 to January 2005']",[],"['weight change', 'median duration of diabetes', 'weight gain', 'Insulin use and weight maintenance', 'Baseline BMI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]",[],"[{'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0240016', 'cui_str': 'Insulin used (attribute)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]",163.0,0.0611025,"At baseline, 88 participants (54%) reported insulin use with an average of 69 (6) units/day.","[{'ForeName': 'Mary Margaret', 'Initials': 'MM', 'LastName': 'Huizinga', 'Affiliation': 'Diabetes Research and Training Center, Vanderbilt University Medical Center, Nashville, Tennessee, USA. mary.margaret.huizinga@vanderbilt.edu'}, {'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Niswender', 'Affiliation': ''}, {'ForeName': 'Tebeb', 'Initials': 'T', 'LastName': 'Gebretsadik', 'Affiliation': ''}, {'ForeName': 'Russell L', 'Initials': 'RL', 'LastName': 'Rothman', 'Affiliation': ''}, {'ForeName': 'Ayumi K', 'Initials': 'AK', 'LastName': 'Shintani', 'Affiliation': ''}, {'ForeName': 'Tom A', 'Initials': 'TA', 'LastName': 'Elasy', 'Affiliation': ''}]","Obesity (Silver Spring, Md.)",['10.1038/oby.2008.301']
1821,31524498,"Dapagliflozin Effects on Biomarkers, Symptoms, and Functional Status in Patients With Heart Failure With Reduced Ejection Fraction: The DEFINE-HF Trial.","BACKGROUND


Outcome trials in patients with type 2 diabetes mellitus have demonstrated reduced hospitalizations for heart failure (HF) with sodium-glucose co-transporter-2 inhibitors. However, few of these patients had HF, and those that did were not well-characterized. Thus, the effects of sodium-glucose co-transporter-2 inhibitors in patients with established HF with reduced ejection fraction, including those with and without type 2 diabetes mellitus, remain unknown.
METHODS


DEFINE-HF (Dapagliflozin Effects on Biomarkers, Symptoms and Functional Status in Patients with HF with Reduced Ejection Fraction) was an investigator-initiated, multi-center, randomized controlled trial of HF patients with left ventricular ejection fraction ≤40%, New York Heart Association (NYHA) class II-III, estimated glomerular filtration rate ≥30 mL/min/1.73m 2 , and elevated natriuretic peptides. In total, 263 patients were randomized to dapagliflozin 10 mg daily or placebo for 12 weeks. Dual primary outcomes were (1) mean NT-proBNP (N-terminal pro b-type natriuretic peptide) and (2) proportion of patients with ≥5-point increase in HF disease-specific health status on the Kansas City Cardiomyopathy Questionnaire overall summary score, or a ≥20% decrease in NT-proBNP.
RESULTS


Patient characteristics reflected stable, chronic HF with reduced ejection fraction with high use of optimal medical therapy. There was no significant difference in average 6- and 12-week adjusted NT-proBNP with dapagliflozin versus placebo (1133 pg/dL (95% CI 1036-1238) vs 1191 pg/dL (95% CI 1089-1304),  P =0.43). For the second dual-primary outcome of a meaningful improvement in Kansas City Cardiomyopathy Questionnaire overall summary score or NT-proBNP, 61.5% of dapagliflozin-treated patients met this end point versus 50.4% with placebo (adjusted OR 1.8, 95% CI 1.03-3.06, nominal  P =0.039). This was attributable to both higher proportions of patients with ≥5-point improvement in Kansas City Cardiomyopathy Questionnaire overall summary score (42.9 vs 32.5%, adjusted OR 1.73, 95% CI 0.98-3.05), and ≥20% reduction in NT-proBNP (44.0 vs 29.4%, adjusted OR 1.9, 95% CI 1.1-3.3) by 12 weeks. Results were consistent among patients with or without type 2 diabetes mellitus, and other prespecified subgroups (all  P  values for interaction=NS).
CONCLUSIONS


In patients with heart failure and reduced ejection fraction, use of dapagliflozin over 12 weeks did not affect mean NT-proBNP but increased the proportion of patients experiencing clinically meaningful improvements in HF-related health status or natriuretic peptides. Benefits of dapagliflozin on clinically meaningful HF measures appear to extend to patients without type 2 diabetes mellitus.
CLINICAL TRIAL REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT02653482.",2019,There was no significant difference in average 6- and 12-week adjusted NT-proBNP with dapagliflozin versus placebo (1133 pg/dL (95% CI 1036-1238) vs 1191 pg/dL,"['≥30', 'patients with established HF with reduced ejection fraction, including those with and without type 2 diabetes mellitus, remain unknown', 'Patients With Heart Failure', 'patients with type 2 diabetes mellitus', 'Patients with HF with Reduced Ejection Fraction) was an investigator-initiated, multi-center, randomized controlled trial of HF patients with left ventricular ejection fraction ≤40%, New York Heart Association (NYHA) class II-III, estimated glomerular filtration rate', 'patients without type 2 diabetes mellitus', '263 patients']","['dapagliflozin 10 mg daily or placebo', 'dapagliflozin', 'placebo', 'HF (Dapagliflozin', 'Dapagliflozin', 'sodium-glucose co-transporter-2 inhibitors']","['elevated natriuretic peptides', 'NT-proBNP', 'mean NT-proBNP', 'Kansas City Cardiomyopathy Questionnaire overall summary score', 'mean NT-proBNP (N-terminal pro b-type natriuretic peptide) and (2) proportion of patients with ≥5-point increase in HF disease-specific health status on the Kansas City Cardiomyopathy Questionnaire overall summary score', 'Kansas City Cardiomyopathy Questionnaire overall summary score or NT-proBNP', 'Biomarkers, Symptoms, and Functional Status', 'Ejection Fraction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C3811844'}, {'cui': 'C4517671', 'cui_str': '263'}]","[{'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}]","[{'cui': 'C1144709', 'cui_str': 'Natriuretic Peptides'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]",263.0,0.228944,There was no significant difference in average 6- and 12-week adjusted NT-proBNP with dapagliflozin versus placebo (1133 pg/dL (95% CI 1036-1238) vs 1191 pg/dL,"[{'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Nassif', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (M.E.N., S.L.W., F.T., Y.K., B.A., M.K.).""}, {'ForeName': 'Sheryl L', 'Initials': 'SL', 'LastName': 'Windsor', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (M.E.N., S.L.W., F.T., Y.K., B.A., M.K.).""}, {'ForeName': 'Fengming', 'Initials': 'F', 'LastName': 'Tang', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (M.E.N., S.L.W., F.T., Y.K., B.A., M.K.).""}, {'ForeName': 'Yevgeniy', 'Initials': 'Y', 'LastName': 'Khariton', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (M.E.N., S.L.W., F.T., Y.K., B.A., M.K.).""}, {'ForeName': 'Mansoor', 'Initials': 'M', 'LastName': 'Husain', 'Affiliation': 'Toronto General Hospital Research Institute, University Health Network, Toronto, Canada (M.H.).'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Yale University School of Medicine, New Haven, CT (S.E.I.).'}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas (D.K.M., M.H.D.).'}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': 'University of Michigan School of Medicine, Ann Arbor (B.P.).'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Scirica', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (B.M.S., M.M.G.).""}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Austin', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (M.E.N., S.L.W., F.T., Y.K., B.A., M.K.).""}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Drazner', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas (D.K.M., M.H.D.).'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Fong', 'Affiliation': 'Keck School of Medicine of USC, University of Southern California, Los Angeles (M.W.F.).'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Givertz', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (B.M.S., M.M.G.).""}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Gordon', 'Affiliation': 'NorthShore University, Evanston, IL (R.A.G.).'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Jermyn', 'Affiliation': 'St. Francis Hospital, Roslyn, NY (R.J.).'}, {'ForeName': 'Stuart D', 'Initials': 'SD', 'LastName': 'Katz', 'Affiliation': 'New York University Langone Health, New York (S.D.K.).'}, {'ForeName': 'Sumant', 'Initials': 'S', 'LastName': 'Lamba', 'Affiliation': 'First Coast Cardiovascular Institute, Jacksonville, FL (S.L.).'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Lanfear', 'Affiliation': 'Henry Ford Hospital, Detroit, MI (D.E.L.).'}, {'ForeName': 'Shane J', 'Initials': 'SJ', 'LastName': 'LaRue', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO (S.J.L.).'}, {'ForeName': 'JoAnn', 'Initials': 'J', 'LastName': 'Lindenfeld', 'Affiliation': 'Vanderbilt University, Nashville, TN (J.L.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Malone', 'Affiliation': 'Charlotte Heart Group Research Center, Port Charlotte, FL (M.M.).'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Margulies', 'Affiliation': 'University of Pennsylvania, Philadelphia (K.M.).'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Duke University, Durham, NC (R.J.M.).'}, {'ForeName': 'R Kannan', 'Initials': 'RK', 'LastName': 'Mutharasan', 'Affiliation': 'Northwestern University, Chicago, IL (R.K.M.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pursley', 'Affiliation': 'Heart Group of the Eastern Shore, Fairhope, AL (M.P.).'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Umpierrez', 'Affiliation': 'Emory University, Atlanta, GA (G.U.).'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (M.E.N., S.L.W., F.T., Y.K., B.A., M.K.).""}]",Circulation,['10.1161/CIRCULATIONAHA.119.042929']
1822,31804860,EMERGING-CTONG 1103: For Achieving High-Quality Evidence in a Randomized Phase II Trial.,,2020,,['CTONG 1103'],[],[],[],[],[],,0.0279451,,"[{'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Tateishi', 'Affiliation': 'Akiko Tateishi, MD; Hiroto Ishiki, MD; Emi Kubo, MD; and Eriko Satomi, MD, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Ishiki', 'Affiliation': 'Akiko Tateishi, MD; Hiroto Ishiki, MD; Emi Kubo, MD; and Eriko Satomi, MD, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Emi', 'Initials': 'E', 'LastName': 'Kubo', 'Affiliation': 'Akiko Tateishi, MD; Hiroto Ishiki, MD; Emi Kubo, MD; and Eriko Satomi, MD, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Eriko', 'Initials': 'E', 'LastName': 'Satomi', 'Affiliation': 'Akiko Tateishi, MD; Hiroto Ishiki, MD; Emi Kubo, MD; and Eriko Satomi, MD, National Cancer Center Hospital, Tokyo, Japan.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01976']
1823,31524828,Effects of Exercise on Plantar Pressure during Walking in Children with Overweight/Obesity.,"PURPOSE


To investigate the effect of a 13-wk exercise program, based on ""movement quality"" and ""multigames"" work, on plantar pressure during walking in children with overweight/obesity (OW/OB).
METHOD


Seventy children (10.8 ± 1.2 yr, 58.5% girls) with OW/OB, as defined by the World Obesity Federation, were assigned to either a 13-wk exercise program (intervention group [EG]; n = 39), or to a usual lifestyle control group (CG) (n = 31). Children underwent assessments of basic anthropometry (weight and height) and plantar pressure during walking before and after the intervention period, recording plantar surface area (cm), maximum force (N), and force-time integrals (N·s).
RESULTS


After the 13-wk intervention period, the EG participants showed no significant change in total plantar surface area, while the CG participants experienced an increase in this variable (small effect size, -2.5 SD; P = 0.015). Compared with the GC participants, the EG participants showed a greater increase in the maximum force supported beneath the forefoot during walking at the end of the intervention period (small effect size, 0.33 SD; P = 0.012), specifically under the lateral and medial forefoot (both P < 0.05). Force-time changed similarly in both groups by the end of the intervention period (all regions P > 0.05).
CONCLUSIONS


These results suggest the exercise program led to positive structural and functional changes in plantar pressure during walking. The increase in maximum force supported by the forefoot in the EG children might indicate a change toward a more normal foot rollover pattern and a more adult gait.",2020,"Force-time changed similarly in both groups by the end of the intervention period (all regions p>0.05).
","['Seventy children (10.8 ± 1.2 years, 58.5% girls) with OW/OB, as defined by the World Obesity Federation', 'Children with Overweight/Obesity', 'children with overweight/obesity (OW/OB']","['exercise program', 'Exercise', '13-week exercise program (intervention group [EG]; n=39), or to a usual lifestyle control group (CG', '13-week exercise program']","['Force-time', 'Plantar Pressure', 'total plantar surface area', 'basic anthropometry (weight and height) and plantar pressure', 'plantar pressure']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0442036', 'cui_str': 'Plantar (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",70.0,0.0203797,"Force-time changed similarly in both groups by the end of the intervention period (all regions p>0.05).
","[{'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Molina-Garcia', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical and Sports Education, Faculty of Sport Sciences, University of Granada, Granada, SPAIN.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Miranda-Aparicio', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical and Sports Education, Faculty of Sport Sciences, University of Granada, Granada, SPAIN.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Molina-Molina', 'Affiliation': 'Research Group CTS-545 ERGOLAB ""Sport Physical Activity and Ergonomy to Life Quality,"" Department of Physical and Sports Education, Faculty of Sports Science, University of Granada, Granada, SPAIN.'}, {'ForeName': 'Abel', 'Initials': 'A', 'LastName': 'Plaza-Florido', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical and Sports Education, Faculty of Sport Sciences, University of Granada, Granada, SPAIN.'}, {'ForeName': 'Jairo H', 'Initials': 'JH', 'LastName': 'Migueles', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical and Sports Education, Faculty of Sport Sciences, University of Granada, Granada, SPAIN.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Mora-Gonzalez', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical and Sports Education, Faculty of Sport Sciences, University of Granada, Granada, SPAIN.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Cadenas-Sanchez', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical and Sports Education, Faculty of Sport Sciences, University of Granada, Granada, SPAIN.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Esteban-Cornejo', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical and Sports Education, Faculty of Sport Sciences, University of Granada, Granada, SPAIN.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Rodriguez-Ayllon', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical and Sports Education, Faculty of Sport Sciences, University of Granada, Granada, SPAIN.'}, {'ForeName': 'Patricio', 'Initials': 'P', 'LastName': 'Solis-Urra', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical and Sports Education, Faculty of Sport Sciences, University of Granada, Granada, SPAIN.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Vanrenterghem', 'Affiliation': 'Department of Rehabilitation Sciences, KU Leuven-University of Leuven, BELGIUM.'}, {'ForeName': 'Francisco B', 'Initials': 'FB', 'LastName': 'Ortega', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical and Sports Education, Faculty of Sport Sciences, University of Granada, Granada, SPAIN.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002157']
1824,32427638,The 11th Trial of a Cardiovascular Clinical Trialist: Coronavirus-2: Part 1.,,2020,,[],[],[],[],[],[],,0.0179934,,"[{'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Frishman', 'Affiliation': 'From the Department of Medicine, New York Medical College/Westchester Medical Center, Valhalla, New York, NY.'}]",Cardiology in review,['10.1097/CRD.0000000000000316']
1825,32428843,Aquatic exercising may improve sexual function in females with multiple sclerosis - an exploratory study.,"BACKGROUND


Persons with multiple sclerosis (PwMS) report impaired sexual function, and this is particularly prevalent and burdensome for females with MS. The present study included a randomized controlled trial (RCT) design and examined the effect of aquatic exercise training on sexual function among females with MS.
METHODS


The sample consisted of 60 married female PwMS (mean age: 37.68 years; median EDSS: 1.75) who were randomly assigned into one of the following conditions: aquatic exercise twice a week (2x/w); aquatic exercise three times a week (3x/w); active control condition (ACC). Participants completed questionnaires regarding sexual function (desire, arousal, lubrication, orgasm, satisfaction, pain), symptoms of depression, sleep complaints, fatigue, and couple satisfaction before and after the 8-week study period.
RESULTS


The interventions had significant and positive effects on the overall score of sexual function (p < .001, η ρ 2  = .35), all subscales (desire (p = .002, 2 = .20), arousal (p = .01, 2 =.15), lubrication (p = .011, 2 = .15), orgasm (p = .007, 2 = .16), satisfaction (p = .023, 2 = .13), pain (p = .02, 2 = .13)) and depression (p =.002, 2 = .20).The interventions had no significant and positive effects on fatigue (p = .31, 2 = .04) sleep complaints (p = .079, 2= .087), and couple satisfaction (p = .69, 2 = .01) compared with the active control condition.
CONCLUSIONS


Aquatic exercise training may improve sexual function among female PwMS, but this requires further examination using a large sample pre-screened for sexual dysfunction. If confirmed, the present findings are of clinical and practical importance for females with MS.",2020,"interventions had no significant and positive effects on fatigue (p = .31, 2 = .04) sleep complaints (p = .079, 2= .087), and couple satisfaction (p = .69, 2 = .01) compared with the active control condition.
","['Persons with multiple sclerosis (PwMS', 'females with multiple sclerosis', 'females with MS.\nMETHODS', 'females with MS', '60 married female PwMS (mean age: 37.68 years; median EDSS: 1.75']","['Aquatic exercise training', 'aquatic exercise twice a week (2x/w); aquatic exercise three times a week (3x/w); active control condition (ACC', 'aquatic exercise training', 'Aquatic exercising']","['arousal', 'overall score of sexual function', 'fatigue', 'sleep complaints', 'couple satisfaction', 'questionnaires regarding sexual function (desire, arousal, lubrication, orgasm, satisfaction, pain), symptoms of depression, sleep complaints, fatigue, and couple satisfaction', 'sexual function', 'satisfaction', 'pain', 'depression', 'lubrication']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C4517514', 'cui_str': '1.75'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024069', 'cui_str': 'Lubrication'}, {'cui': 'C0029260', 'cui_str': 'Sexual orgasm'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",60.0,0.044883,"interventions had no significant and positive effects on fatigue (p = .31, 2 = .04) sleep complaints (p = .079, 2= .087), and couple satisfaction (p = .69, 2 = .01) compared with the active control condition.
","[{'ForeName': 'Dena', 'Initials': 'D', 'LastName': 'Sadeghi Bahmani', 'Affiliation': 'University of Basel, Psychiatric Clinics (UPK), Center of Affective, Stress and Sleep Disorders (ZASS), Basel, Switzerland; Departments of Physical Therapy, University of Alabama at Birmingham, Birmingham, Alabama, USA; Kermanshah University of Medical Sciences (KUMS), Sleep Disorders Research Center, Kermanshah, Iran. Electronic address: dena.sadeghibahmani@upk.ch.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Motl', 'Affiliation': 'Departments of Physical Therapy, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Razazian', 'Affiliation': 'Kermanshah University of Medical Sciences, Neurology Department, Kermanshah, Iran.'}, {'ForeName': 'Habibolah', 'Initials': 'H', 'LastName': 'Khazaie', 'Affiliation': 'Kermanshah University of Medical Sciences (KUMS), Sleep Disorders Research Center, Kermanshah, Iran.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Brand', 'Affiliation': 'University of Basel, Psychiatric Clinics (UPK), Center of Affective, Stress and Sleep Disorders (ZASS), Basel, Switzerland; Kermanshah University of Medical Sciences (KUMS), Sleep Disorders Research Center, Kermanshah, Iran; Kermanshah University of Medical Sciences (KUMS), Substance Abuse Prevention Research Center, Health Institute, Kermanshah, Iran; University of Basel, Department of Sport, Exercise, and Health, Division of Sport Science and Psychosocial Health, Basel, Switzerland; Tehran University of Medical Sciences, School of Medicine, Tehran, Iran.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102106']
1826,32007346,Increased global cognition correlates with increased thalamo-temporal connectivity in response to targeted cognitive training for recent onset schizophrenia.,"Patients with schizophrenia exhibit disrupted thalamocortical connections that relate to aspects of symptoms and deficits in cognition. Targeted cognitive training (TCT) of the auditory system in schizophrenia has been shown to improve cognition, but its impact on thalamocortical connectivity is not known. Here we examined thalamocortical connections that may be neuroplastic in response to TCT using a region of interest (ROI) approach. Participants were randomly assigned to either 40 h of TCT (N = 24) or an active control condition (CG; N = 20). Participants underwent resting state fMRI and cognitive testing both before and after training. Changes in thalamocortical connectivity were measured in 15 ROIs derived from a previous study comparing a large sample of schizophrenia subjects with healthy controls. A significant group by time interaction was observed in a left superior temporal ROI which was previously found to exhibit thalamocortical hyper-connectivity in patients with schizophrenia. Changes in this ROI reflected thalamic connectivity increases in the TCT group, while the CG group showed decreases. Additionally, the relationship between connectivity change and change in global cognition showed a slope difference between groups, with increases in thalamo-temporal connectivity correlating with improvements in global cognition in TCT. No significant relationships were observed with changes in clinical symptoms or functioning. These findings demonstrate that TCT may influence intrinsic functional connections in young individuals with schizophrenia, such that improvements in cognition correspond to compensatory increases in connectivity in a temporal region previously shown to exhibit thalamic hyper-connectivity.",2020,A significant group by time interaction was observed in a left superior temporal ROI which was previously found to exhibit thalamocortical hyper-connectivity in patients with schizophrenia.,"['patients with schizophrenia', 'Patients with schizophrenia', 'schizophrenia subjects with healthy controls', 'young individuals with schizophrenia']","['Targeted cognitive training (TCT', 'TCT']","['clinical symptoms or functioning', 'connectivity change and change in global cognition', 'thalamic connectivity', 'thalamocortical connectivity', 'time interaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0677634', 'cui_str': 'Reptilase Time'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]",,0.0173449,A significant group by time interaction was observed in a left superior temporal ROI which was previously found to exhibit thalamocortical hyper-connectivity in patients with schizophrenia.,"[{'ForeName': 'Ian S', 'Initials': 'IS', 'LastName': 'Ramsay', 'Affiliation': 'University of Minnesota, Department of Psychiatry, USA. Electronic address: ramsa045@umn.edu.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Roach', 'Affiliation': 'Veterans Affairs Medical Center San Francisco, USA.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Fryer', 'Affiliation': 'University of California, San Francisco Department of Psychiatry, USA; Veterans Affairs Medical Center San Francisco, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Fisher', 'Affiliation': 'University of Minnesota, Department of Psychiatry, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Loewy', 'Affiliation': 'University of California, San Francisco Department of Psychiatry, USA.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Ford', 'Affiliation': 'University of California, San Francisco Department of Psychiatry, USA; Veterans Affairs Medical Center San Francisco, USA.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Vinogradov', 'Affiliation': 'University of Minnesota, Department of Psychiatry, USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Mathalon', 'Affiliation': 'University of California, San Francisco Department of Psychiatry, USA; Veterans Affairs Medical Center San Francisco, USA.'}]",Schizophrenia research,['10.1016/j.schres.2020.01.020']
1827,32050105,"Clinical, host-derived immune biomarkers and microbiological outcomes with adjunctive photochemotherapy compared with local antimicrobial therapy in the treatment of peri-implantitis in cigarette smokers.","AIM


The aim of this study was designed to assess the peri-implant oral hygiene parameters, clinical, radiographic, host-derived immune biomarkers and microbiological levels after photochemotherapy (PCT) and local antibiotic therapy (LAT) in peri-implantitis lesions among cigarette smokers.
MATERIALS AND METHODS


Fifty current cigarette smokers with peri-implantitis were divided into two groups: PCT and LAT. Test implants received PCT that consisted of toluidine blue photosensitizer and application of 660 nm diode laser with a total of 100 mW power and 124.3 W/cm 2  energy using continuous mode of irrigation for 60 s. Control implants received one-unit subgingival application of metronidazole gel in viscous consistency. Clinical measurements included the assessment of plaque scores (PS), bleeding on probing (BOP), probing depth (PD) and clinical attachment level (CAL). Intraoral standardized digital peri-apical radiographs were taken at baseline and at 12 months. Interleukin (IL)-1β and matrix metalloproteinase (MMP)-1 in the PICF were determined using the manufacturers guide from one-step enzyme-linked immunosorbent assay. Real-time polymerase chain reaction (PCR) for Parvimonas micra, Porphyromonas gingivalis and Tannerella forsythia was performed and counts evaluated at baseline, 3, 6 and 12-months.
RESULTS


Plaque scores reduced in both groups (p < 0.05). Mean BOP percentage significantly increased in both the groups at 1-month follow-up compared to baseline. Following this period, BOP showed reduction from 1-month to consecutive follow-up periods. The PD significantly reduced in both the groups with no statistically significant difference when compared between PCT and LAT groups at follow-up (p > 0.05). CAL did not change over the period and between both groups (p > 0.05). The differences from baseline to 12 months and between the groups for mesial and distal crestal bone levels did not show any statistical significance (p > 0.05). The levels of IL-1β significantly dropped from baseline to 12 months in the LAT group (p < 0.05). However, for PCT groups, the levels of IL-1β significantly reduced only at 12-month visit follow-up (p < 0.05). MMP-1 showed statistically significant reduction at 9 and 12-months compared with baseline for LAT group. Both P. gingivalis and T. forsythia showed statistically significant reduction in both the groups when values were compared from baseline to 3-, 6- and 12-months follow-up (p < 0.05). However, these differences were not significant when compared between the groups (p > 0.05).
CONCLUSION


Both PCT and LAT showed equal efficacies in improving clinical, host-derived immune biomarkers and microbiological parameters in peri-implant infection in cigarette smokers.",2020,The differences from baseline to 12 months and between the groups for mesial and distal crestal bone levels did not show any statistical significance (p > 0.05).,"['Fifty current cigarette smokers with peri-implantitis', 'cigarette smokers', 'peri-implantitis lesions among cigarette smokers']","['LAT', 'local antimicrobial therapy', 'adjunctive photochemotherapy', 'metronidazole gel', 'PCT and LAT', 'PCT', 'photochemotherapy (PCT) and local antibiotic therapy (LAT']","['CAL', 'Real-time polymerase chain reaction (PCR) for Parvimonas micra, Porphyromonas gingivalis and Tannerella forsythia', 'Mean BOP percentage', 'levels of IL-1β', 'Plaque scores', 'mesial and distal crestal bone levels', 'plaque scores (PS), bleeding on probing (BOP), probing depth (PD) and clinical attachment level (CAL', 'Interleukin (IL)-1β and matrix metalloproteinase (MMP)-1']","[{'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C2936258', 'cui_str': 'Periimplantitis'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]","[{'cui': 'C0023979', 'cui_str': 'LATS'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0031740', 'cui_str': 'Photodynamic Therapy'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0162566', 'cui_str': 'Porphyria Cutanea Tarda'}, {'cui': 'C0338237', 'cui_str': 'Antibiotic therapy (procedure)'}]","[{'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0317944', 'cui_str': 'Peptostreptococcus micros'}, {'cui': 'C0206347', 'cui_str': 'Porphyromonas'}, {'cui': 'C0314961', 'cui_str': 'Bacteroides forsythus'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0549183', 'cui_str': 'Midline (qualifier value)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0127082', 'cui_str': 'Interstitial Collagenase'}]",50.0,0.0244407,The differences from baseline to 12 months and between the groups for mesial and distal crestal bone levels did not show any statistical significance (p > 0.05).,"[{'ForeName': 'Abdulaziz Abdullah', 'Initials': 'AA', 'LastName': 'Al-Khureif', 'Affiliation': 'Dental Health Department, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia. Electronic address: aalkhuraif@ksu.edu.sa.'}, {'ForeName': 'Badreldin A', 'Initials': 'BA', 'LastName': 'Mohamed', 'Affiliation': 'Community Health Department, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Adel Zia', 'Initials': 'AZ', 'LastName': 'Siddiqui', 'Affiliation': 'Dental Materials Department, Baqai Dental College, Baqai Medical University, Karachi, Pakistan.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Hashem', 'Affiliation': 'Dental Health Department, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Aftab Ahmed', 'Initials': 'AA', 'LastName': 'Khan', 'Affiliation': 'Dental Biomaterials Research Chair, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Darshan Devang', 'Initials': 'DD', 'LastName': 'Divakar', 'Affiliation': 'Dental Biomaterials Research Chair, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101684']
1828,32028078,Assessing gait efficacy in older adults: An analysis using item response theory.,"BACKGROUND


Assessing confidence in walking in older adults is important, as mobility is a critical aspect of independence and function, and self-report provides complementary information to performance-based measures. The modified Gait Efficacy Scale (mGES) is a self-report measure used to examine confidence in walking.
RESEARCH QUESTION


What are the psychometric properties of the mGES at the item level? Are there opportunities for improvement?
METHODS


We performed a secondary analysis of baseline data from a cluster randomized trial of 424 community-dwelling older adults and reliability data from 123 participants. We fitted a graded response model to dissect the mGES to the item and individual response level and examined opportunities to improve and possible shorten the mGES. We examined psychometric characteristics such as internal consistency, test-retest reliability and construct validity with respect to other relevant measures.
RESULTS


Mobility tasks such as navigating stairs and curbs with separate items for going up and down largely provide the same information on confidence, with downward direction providing slightly more. It may be reasonable to consider removal of walking 1/2 mile, stepping down and/or stair tasks with railings items due to little or duplicate information contributed compared to other items. The shortened scales proposed by removing the above items had similar psychometric properties to mGES.
SIGNIFICANCE


The mGES has good psychometric properties, but can be potentially shortened to substantially reduce responder burden. The upward direction curb and stairs items can be removed to result in a 7-item scale with virtually no loss of desirable psychometrics. An alternative 3-item version, level surface walking, stepping down curb and climbing up stairs without a railing items, entails only a minimal loss in psychometric properties.",2020,"The shortened scales proposed by removing the above items had similar psychometric properties to mGES.
","['older adults', '424 community-dwelling older adults and reliability data from 123 participants']",[],"['gait efficacy', 'modified Gait Efficacy Scale (mGES']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}]",[],"[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0222045'}]",424.0,0.0239234,"The shortened scales proposed by removing the above items had similar psychometric properties to mGES.
","[{'ForeName': 'Subashan', 'Initials': 'S', 'LastName': 'Perera', 'Affiliation': 'Division of Geriatric Medicine, University of Pittsburgh, 3471 Fifth Avenue, Suite 500, Pittsburgh, PA 15213, USA; Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA, USA. Electronic address: ksp9@pitt.edu.'}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'VanSwearingen', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Bridgeside Point 1, 100 Technology Drive, Suite 210, Pittsburgh, PA 15219, USA. Electronic address: jessievs@pitt.edu.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Shuman', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Bridgeside Point 1, 100 Technology Drive, Suite 210, Pittsburgh, PA 15219, USA. Electronic address: vls40@pitt.edu.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Brach', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Bridgeside Point 1, 100 Technology Drive, Suite 210, Pittsburgh, PA 15219, USA. Electronic address: jbrach@pitt.edu.'}]",Gait & posture,['10.1016/j.gaitpost.2020.01.028']
1829,32035806,"Letter to the Editor, ""A randomized study of botulinum toxin versus botulinum toxin plus physical therapy for treatment of cervical dystonia"".",,2020,,['cervical dystonia'],['botulinum toxin versus botulinum toxin plus physical therapy'],[],"[{'cui': 'C0949445', 'cui_str': 'Cervical Dystonia'}]","[{'cui': 'C0006055', 'cui_str': 'Botulin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}]",[],,0.0246716,,"[{'ForeName': 'Melani J', 'Initials': 'MJ', 'LastName': 'Boyce', 'Affiliation': 'Graduate School of Health, Discipline of Physiotherapy, University of Technology Sydney, Sydney, Australia; Physiotherapy Department, Westmead Hospital, Sydney, Australia. Electronic address: melani.boyce@health.nsw.gov.au.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Kennedy', 'Affiliation': 'Graduate School of Health, Discipline of Physiotherapy, University of Technology Sydney, Sydney, Australia.'}, {'ForeName': 'Alana B', 'Initials': 'AB', 'LastName': 'McCambridge', 'Affiliation': 'Graduate School of Health, Discipline of Physiotherapy, University of Technology Sydney, Sydney, Australia.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.01.015']
1830,31978318,The Source of the Message Matters: A Randomized Study Evaluating the Impact of a Survey Source on Response Rate.,,2020,,[],[],[],[],[],[],,0.0310443,,"[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Hauw-Berlemont', 'Affiliation': 'Columbia University Medical CenterNew York, New York.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Serra', 'Affiliation': 'Columbia University Medical CenterNew York, New York.'}, {'ForeName': 'Holden', 'Initials': 'H', 'LastName': 'Groves', 'Affiliation': 'Columbia University Medical CenterNew York, New York.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Dzierba', 'Affiliation': 'Columbia University Medical CenterNew York, New York.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Louh', 'Affiliation': 'Columbia University Medical CenterNew York, New York.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'Columbia University Medical CenterNew York, New York.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Yip', 'Affiliation': 'Columbia University Medical CenterNew York, New York.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Moitra', 'Affiliation': 'Columbia University Medical CenterNew York, New York.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201906-482RL']
1831,32044587,Repetition priming with no antipriming in picture identification.,"Previous studies have shown that the processing of a stimulus is facilitated when that stimulus is repeated compared to when it appears the first time, and this phenomenon is called repetition priming (RP). One explanation for RP is that initial processing of a stimulus strengthens connections within the visual representation, enabling subsequent processing of the same stimulus to be more efficient. More recently, it has been reported that presenting an object with features that overlap with those in a subsequent stimulus impairs the latter's processing, and this cost is termed antipriming (AP). AP is said to be the natural antithesis of RP, and it manifests when two objects share component features, thereby having overlapping representations. In two experiments, we investigated RP and AP in a picture naming task. Following previous research, we used a 4-phase paradigm, in which RP and AP were measured, respectively, by an increase or a decrease in performance for repeated or novel stimuli in Phase 4 compared with the baseline performance in Phase 2. We used a fully randomized design in Experiment 1, and a pseudo-randomized design in stimulus selection but a randomized design in presentation location in Experiment 2. We found robust RP in both experiments, but neither experiment showed any evidence of AP. Our results indicate that RP and AP do not always manifest within the same experiment, and that the relationship between these two effects may be more complex than previously understood.",2020,"We found robust RP in both experiments, but neither experiment showed any evidence of AP.",[],[],[],[],[],[],,0.0251536,"We found robust RP in both experiments, but neither experiment showed any evidence of AP.","[{'ForeName': 'Ailsa', 'Initials': 'A', 'LastName': 'Humphries', 'Affiliation': 'Department of Psychology, University of Canterbury, Christchurch, New Zealand. Electronic address: ailsa.walker@canterbury.ac.nz.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Psychology, University of Canterbury, Christchurch, New Zealand.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Wiltshire', 'Affiliation': 'Department of Psychology, University of Canterbury, Christchurch, New Zealand.'}]",Vision research,['10.1016/j.visres.2019.09.011']
1832,32119692,Language effects on bargaining.,"Language is critical to coordination in groups. Though, how language affects coordination in groups is not well understood. We prime distributive and integrative language in a bargaining experiment to better understand the links between group outcomes and communication. We accomplish this by priming interests or positions language in randomized groups. We find that priming positions as opposed to interests language leads to agreements where controllers, subjects with unilateral authority over the group outcome, receive a larger share of the benefits but where the total benefits to the group are unaffected. In contrast to common justifications for the use of integrative language in bargaining, our experimental approach revealed no significant differences between priming interests and positions language in regards to increasing joint outcomes for the groups. Across treatments, we find subjects that use gain frames and make reference to visuals aids during bargaining experience larger gains for the group, while loss frames and pro-self language experience larger gains for the individual through side payments. This finding suggests a bargainer's dilemma: whether to employ language that claims a larger share of group's assets or employ language to increase joint gains.",2020,"In contrast to common justifications for the use of integrative language in bargaining, our experimental approach revealed no significant differences between priming interests and positions language in regards to increasing joint outcomes for the groups.",[],[],[],[],[],[],,0.0233567,"In contrast to common justifications for the use of integrative language in bargaining, our experimental approach revealed no significant differences between priming interests and positions language in regards to increasing joint outcomes for the groups.","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Weir', 'Affiliation': 'Dept. of Environmental and Natural Resource Economics, University of Rhode Island, Kingston, RI, United States of America.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Ashcraft', 'Affiliation': 'Natural Resources and the Environment, University of New Hampshire, Durham, NH, United States of America.'}, {'ForeName': 'Natallia', 'Initials': 'N', 'LastName': 'Leuchanka Diessner', 'Affiliation': 'Natural Resources and the Environment, University of New Hampshire, Durham, NH, United States of America.'}, {'ForeName': 'Bridie', 'Initials': 'B', 'LastName': 'McGreavy', 'Affiliation': 'Department of Communication and Journalism, University of Maine, Orono, ME, United States of America.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Vogler', 'Affiliation': 'Rhode Island School of Design, Providence, RI, United States of America.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Guilfoos', 'Affiliation': 'Dept. of Environmental and Natural Resource Economics, University of Rhode Island, Kingston, RI, United States of America.'}]",PloS one,['10.1371/journal.pone.0229501']
1833,32113635,"[Do have patients with ""Hashimoto disease"" to be operated on? A critical reading of The Norvegian Trial Surgery Study, a prospective randomized investigation published in Annals of Internal Medicine (2019)].",,2020,,[],[],[],[],[],[],,0.037148,,"[{'ForeName': 'J-L', 'Initials': 'JL', 'LastName': 'Wémeau', 'Affiliation': 'Université de Lille, 765, domaine de la Vigne, 59910 Bondues, France. Electronic address: jl-wemeau@hotmail.fr.'}]",La Revue de medecine interne,['10.1016/j.revmed.2020.02.001']
1834,32428523,A randomized clinical trial to arrest dentin caries in young children using silver diamine fluoride.,"OBJECTIVES


The study aimed to compare the effectiveness of 38% silver diamine fluoride (SDF) solution, and 5% sodium fluoride (NaF) varnish applied semiannually in arresting dentin caries in young children with high caries risk.
METHODS


Children aged 1-3 years who had at least one active dentin carious lesion were randomly allocated into 2 groups as follows: Group 1 = 38% SDF (Topamine), and Group 2 = 5% NaF varnish (Duraphat). Both agents were applied every 6 months onto the carious surface. Lesion activity was assessed by the visual-tactile examination. Baseline and follow-up examinations were conducted by the same examiner. The children's demographic background, oral health-related habits, and oral hygiene practices, as well as parental satisfaction with children's dental appearance were collected at baseline and the 12-month follow-up.
RESULTS


At baseline, 153 and 149 children were recruited in Group 1 and Group 2, respectively. The mean dmfs scores in Groups 1 and 2 were 8.89 and 9.79, respectively. After 12 months, 87.1% remained in the study. The caries arrest rate of Group 1 (35.7%) was significantly higher than that of Group 2 (20.9%) (p < 0.001). The results of the multilevel logistic regression analysis confirmed that the treatment in Group 1 was more effective in arresting dentin carious lesions than that of Group 2 (OR = 2.04; 95% CI, 1.41-2.96). The presence of plaque on caries lesions, tooth type, tooth surface type, frequency of milk feeding, snack taking, and family income influenced on caries activity. Regardless of the intervention groups, there were no differences in parental satisfaction with on the child's dental appearance before and after receiving the intervention.
CONCLUSION


Based on the 12-month results, 38% SDF is more effective than 5% NaF varnish in arresting dentin carious lesions in young children. SDF has no negative impact on parental satisfaction with the child's dental appearance.
CLINICAL SIGNIFICANCE


To control dentin carious lesions in young children with high caries risk, 38% SDF is more effective than 5% NaF varnish.",2020,The caries arrest rate of Group 1 (35.7%) was significantly higher than that of Group 2 (20.9%) (p <  0.001).,"['young children using', 'young children', 'Children aged 1-3 years who had at least one active dentin carious lesion', 'young children with high caries risk']","['SDF', '38% silver diamine fluoride (SDF) solution, and 5% sodium fluoride (NaF) varnish', 'silver diamine fluoride', 'NaF varnish', 'SDF (Topamine), and Group 2\u2009=\u20095% NaF varnish (Duraphat']","['dentin carious lesions', 'mean dmfs scores', 'Lesion activity', 'caries arrest rate', 'dentin caries', 'effective in arresting dentin carious lesions', 'parental satisfaction', 'presence of plaque on caries lesions, tooth type, tooth surface type, frequency of milk feeding, snack taking, and family income influenced on caries activity']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0074538', 'cui_str': 'Silver diamine fluoride'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0042359', 'cui_str': 'Varnish'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0058817', 'cui_str': 'Duraphat'}]","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0266848', 'cui_str': 'Arrested dental caries'}, {'cui': 'C0266846', 'cui_str': 'Dental caries extending into dentin'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0447301', 'cui_str': 'Tooth surface'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0021162', 'cui_str': 'Income'}]",,0.0269155,The caries arrest rate of Group 1 (35.7%) was significantly higher than that of Group 2 (20.9%) (p <  0.001).,"[{'ForeName': 'Sirinan', 'Initials': 'S', 'LastName': 'Mabangkhru', 'Affiliation': 'Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Duangporn', 'Initials': 'D', 'LastName': 'Duangthip', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Chun Hung', 'Initials': 'CH', 'LastName': 'Chu', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Araya', 'Initials': 'A', 'LastName': 'Phonghanyudh', 'Affiliation': 'Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Varangkanar', 'Initials': 'V', 'LastName': 'Jirarattanasopha', 'Affiliation': 'Faculty of Dentistry, Mahidol University, Bangkok, Thailand. Electronic address: Varangkanar.jir@mahidol.ac.th.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103375']
1835,32127261,"Reply to letter to the editor, ""A randomized study of botulinum toxin versus botulinum toxin plus physical therapy for treatment of cervical dystonia.""",,2020,,[],['botulinum toxin versus botulinum toxin plus physical therapy'],[],[],"[{'cui': 'C0006055', 'cui_str': 'Botulin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}]",[],,0.0230456,,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': 'Department of Neurology, University of Florida College of Medicine, Gainesville, FL, USA.'}, {'ForeName': 'Aparna', 'Initials': 'A', 'LastName': 'Wagle Shukla', 'Affiliation': 'Department of Neurology, University of Florida College of Medicine, Gainesville, FL, USA. Electronic address: aparna.shukla@neurology.ufl.edu.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.01.014']
1836,32142507,Evaluation of a very brief pedometer-based physical activity intervention delivered in NHS Health Checks in England: The VBI randomised controlled trial.,"BACKGROUND


The majority of people do not achieve recommended levels of physical activity. There is a need for effective, scalable interventions to promote activity. Self-monitoring by pedometer is a potentially suitable strategy. We assessed the effectiveness and cost-effectiveness of a very brief (5-minute) pedometer-based intervention ('Step It Up') delivered as part of National Health Service (NHS) Health Checks in primary care.
METHODS AND FINDINGS


The Very Brief Intervention (VBI) Trial was a two parallel-group, randomised controlled trial (RCT) with 3-month follow-up, conducted in 23 primary care practices in the East of England. Participants were 1,007 healthy adults aged 40 to 74 years eligible for an NHS Health Check. They were randomly allocated (1:1) using a web-based tool between October 1, 2014, and December 31, 2015, to either intervention (505) or control group (502), stratified by primary care practice. Participants were aware of study group allocation. Control participants received the NHS Health Check only. Intervention participants additionally received Step It Up: a 5-minute face-to-face discussion, written materials, pedometer, and step chart. The primary outcome was accelerometer-based physical activity volume at 3-month follow-up adjusted for sex, 5-year age group, and general practice. Secondary outcomes included time spent in different intensities of physical activity, self-reported physical activity, and economic measures. We conducted an in-depth fidelity assessment on a subsample of Health Check consultations. Participants' mean age was 56 years, two-thirds were female, they were predominantly white, and two-thirds were in paid employment. The primary outcome was available in 859 (85.3%) participants. There was no significant between-group difference in activity volume at 3 months (adjusted intervention effect 8.8 counts per minute [cpm]; 95% CI -18.7 to 36.3; p = 0.53). We found no significant between-group differences in the secondary outcomes of step counts per day, time spent in moderate or vigorous activity, time spent in vigorous activity, and time spent in moderate-intensity activity (accelerometer-derived variables); as well as in total physical activity, home-based activity, work-based activity, leisure-based activity, commuting physical activity, and screen or TV time (self-reported physical activity variables). Of the 505 intervention participants, 491 (97%) received the Step it Up intervention. Analysis of 37 intervention consultations showed that 60% of Step it Up components were delivered faithfully. The intervention cost £18.04 per participant. Incremental cost to the NHS per 1,000-step increase per day was £96 and to society was £239. Adverse events were reported by 5 intervention participants (of which 2 were serious) and 5 control participants (of which 2 were serious). The study's limitations include a participation rate of 16% and low return of audiotapes by practices for fidelity assessment.
CONCLUSIONS


In this large well-conducted trial, we found no evidence of effect of a plausible very brief pedometer intervention embedded in NHS Health Checks on objectively measured activity at 3-month follow-up.
TRIAL REGISTRATION


Current Controlled Trials (ISRCTN72691150).",2020,There was no significant between-group difference in activity volume at 3 months (adjusted intervention effect 8.8 counts per minute [cpm]; 95% CI -18.7 to 36.3; p = 0.53).,"[""Participants' mean age was 56 years, two-thirds were female, they were predominantly white, and two-thirds were in paid employment"", 'England', 'Participants were 1,007 healthy adults aged 40 to 74 years eligible for an NHS Health Check', '23 primary care practices in the East of England']","['NHS Health Check only', 'very brief pedometer-based physical activity intervention', ""very brief (5-minute) pedometer-based intervention ('Step It Up') delivered as part of National Health Service (NHS""]","['Adverse events', 'activity volume', 'accelerometer-based physical activity volume', 'Incremental cost', 'effectiveness and cost-effectiveness', 'step counts per day, time spent in moderate or vigorous activity, time spent in vigorous activity, and time spent in moderate-intensity activity (accelerometer-derived variables); as well as in total physical activity, home-based activity, work-based activity, leisure-based activity, commuting physical activity, and screen or TV time (self-reported physical activity variables', 'time spent in different intensities of physical activity, self-reported physical activity, and economic measures']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205437', 'cui_str': 'Third (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1320371', 'cui_str': 'In paid employment'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0454366', 'cui_str': 'Step ups (regime/therapy)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0009487', 'cui_str': 'Commuting'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",1007.0,0.0874277,There was no significant between-group difference in activity volume at 3 months (adjusted intervention effect 8.8 counts per minute [cpm]; 95% CI -18.7 to 36.3; p = 0.53).,"[{'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Hardeman', 'Affiliation': 'Behavioural and Implementation Science Group, School of Health Sciences, University of East Anglia, Norwich Research Park, Norwich, United Kingdom.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Mitchell', 'Affiliation': 'Behavioural Science Group, Primary Care Unit, Department of Public Health and Primary Care, Cambridge Institute of Public Health, Cambridge, United Kingdom.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Pears', 'Affiliation': 'Behavioural Science Group, Primary Care Unit, Department of Public Health and Primary Care, Cambridge Institute of Public Health, Cambridge, United Kingdom.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Van Emmenis', 'Affiliation': 'Behavioural Science Group, Primary Care Unit, Department of Public Health and Primary Care, Cambridge Institute of Public Health, Cambridge, United Kingdom.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Theil', 'Affiliation': 'Behavioural Science Group, Primary Care Unit, Department of Public Health and Primary Care, Cambridge Institute of Public Health, Cambridge, United Kingdom.'}, {'ForeName': 'Vijay S', 'Initials': 'VS', 'LastName': 'Gc', 'Affiliation': 'Health Economics Group, Norwich Medical School, University of East Anglia, Norwich, United Kingdom.'}, {'ForeName': 'Joana C', 'Initials': 'JC', 'LastName': 'Vasconcelos', 'Affiliation': 'Imperial Clinical Trials Unit, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Westgate', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Brage', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Suhrcke', 'Affiliation': 'Centre for Health Economics, University of York, York, United Kingdom.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Griffin', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Ann Louise', 'Initials': 'AL', 'LastName': 'Kinmonth', 'Affiliation': 'Primary Care Unit, Department of Public Health and Primary Care, Cambridge Institute of Public Health, Cambridge, United Kingdom.'}, {'ForeName': 'Edward C F', 'Initials': 'ECF', 'LastName': 'Wilson', 'Affiliation': 'Health Economics Group, Norwich Medical School, University of East Anglia, Norwich, United Kingdom.'}, {'ForeName': 'A Toby', 'Initials': 'AT', 'LastName': 'Prevost', 'Affiliation': 'Imperial Clinical Trials Unit, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Sutton', 'Affiliation': 'Behavioural Science Group, Primary Care Unit, Department of Public Health and Primary Care, Cambridge Institute of Public Health, Cambridge, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PLoS medicine,['10.1371/journal.pmed.1003046']
1837,32428586,"Integrating an online weight management program with population health management in primary care: Design, methods, and baseline data from the PROPS randomized controlled trial (Partnerships for Reducing Overweight and Obesity with Patient-centered Strategies).","BACKGROUND


Scalable, low-cost weight management strategies are needed in primary care. We conducted a pragmatic, cluster-randomized controlled trial to examine the effectiveness of an online weight management program integrated with population health management support.
METHODS


We adapted an online weight management program and integrated it with population health management support in 15 primary care practices (24 clinics). We randomized the 24 clinics to usual care (UC), online program alone (OP), or combined intervention (CI). Eligible participants had to be ages 20 to 70 and have a recent primary care visit, body mass index (BMI) ≥ 27 and < 40 kg/m 2 , and a diagnosis of hypertension or type 2 diabetes. Participants attended routine visits and completed surveys over 18 months. The primary outcome is absolute weight change at 12 months (± 90 days) after enrollment, calculated from weights measured at primary care visits and recorded in the electronic health record.
RESULTS


We enrolled 840 participants between July 2016 and August 2017 (326 UC, 216 OP, and 298 CI.) At enrollment, participants' mean age was 59.3 years, their mean weight was 203.1 pounds, and their mean BMI was 32.5 kg/m 2 ; 60% of participants were female, 76.8% were white, 96.4% had hypertension, and 24.4% had type 2 diabetes.
CONCLUSION


It is feasible to adapt an online weight management program and integrate it with population health management support in primary care. The results of this trial will provide valuable information about the effectiveness of these strategies in primary care settings. ClinicalTrials.govregistration number:NCT02656693.",2020,"We randomized the 24 clinics to usual care (UC), online program alone (OP), or combined intervention (CI).","['Eligible participants had to be ages 20 to 70 and have a recent primary care visit, body mass index (BMI)\u202f≥\u202f27 and\u202f<\u202f40\u202fkg/m 2 , and a diagnosis of hypertension or type 2 diabetes', '15 primary care practices (24 clinics', ""At enrollment, participants' mean age was 59.3\u202fyears, their mean weight was 203.1 pounds, and their mean BMI was 32.5\u202fkg/m 2 ; 60% of participants were female, 76% were white, 96.4% had hypertension, and 24.4% had type 2 diabetes"", 'We enrolled 840 participants between July 2016 and August 2017 (326 UC, 216 OP, and 298 CI']","['online weight management program with population health management', 'online weight management program and integrated it with population health management support', 'usual care (UC), online program alone (OP), or combined intervention (CI', 'online weight management program integrated with population health management support']","['absolute weight change at 12\u202fmonths (± 90\u202fdays) after enrollment, calculated from weights measured at primary care visits and recorded in the electronic health record']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439219', 'cui_str': 'lb'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4517710', 'cui_str': '32.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C4704688', 'cui_str': 'Population Health Management'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0043101', 'cui_str': 'Weights and Measures'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}]",840.0,0.0950447,"We randomized the 24 clinics to usual care (UC), online program alone (OP), or combined intervention (CI).","[{'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Baer', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America; Harvard T.H. Chan School of Public Health, Boston, MA, United States of America. Electronic address: hbaer@bwh.harvard.edu.""}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'De La Cruz', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Ronen', 'Initials': 'R', 'LastName': 'Rozenblum', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America.""}, {'ForeName': 'Nyryan V', 'Initials': 'NV', 'LastName': 'Nolido', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'E John', 'Initials': 'EJ', 'LastName': 'Orav', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America; Harvard T.H. Chan School of Public Health, Boston, MA, United States of America.""}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Metzler', 'Affiliation': ""Department of Nutrition, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Block', 'Affiliation': ""Harvard Medical School, Boston, MA, United States of America; Department of Population Medicine, Harvard Pilgrim Healthcare Institute, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Florencia', 'Initials': 'F', 'LastName': 'Halperin', 'Affiliation': ""Harvard Medical School, Boston, MA, United States of America; Division of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Katherine D', 'Initials': 'KD', 'LastName': 'McManus', 'Affiliation': ""Department of Nutrition, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Louis J', 'Initials': 'LJ', 'LastName': 'Aronne', 'Affiliation': 'BMIQ Professionals Program, Intellihealth/BMIQ, United States of America; Division of Endocrinology, Diabetes, and Metabolism, Weill Cornell Medicine, New York, NY, United States of America.'}, {'ForeName': 'Guadalupe', 'Initials': 'G', 'LastName': 'Minero', 'Affiliation': 'BMIQ Professionals Program, Intellihealth/BMIQ, United States of America.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Bates', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America; Harvard T.H. Chan School of Public Health, Boston, MA, United States of America.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106026']
1838,32429137,"Crosslinked Hyaluronic Acid Gels for the Prevention of Intrauterine Adhesions after a Hysteroscopic Myomectomy in Women with Submucosal Myomas: A Prospective, Randomized, Controlled Trial.","Intrauterine adhesion (IUA), fibrosis, and scarring resulting from damage to the endometrium is a rare but serious clinical disease, contributing to a significant impairment of reproductive function. Uterine instrumentation, especially that of a hysteroscopic myomectomy, has become the main cause of IUA. Therefore, a prospective randomized controlled study to assess the effectiveness and short-term safety of the use of hyaluronic acid gels in the prevention of IUA after a hysteroscopic myomectomy and an evaluation of the characteristics of IUA observed at follow-up are presented here. A total of 70 patients were analyzed at the end of 16 March 2020. The results show that the incidence of IUA in women who underwent a hysteroscopic myomectomy is 21.4% (15/70), overall. Women treated with hyaluronic acid gels have a statistically significantly lower incidence of IUAs than non-treated women (12.8% vs. 39.1%,  p  = 0.012). In addition, women in the anti-adhesive gel treatment group had a dramatically reduced severity of IUA than women in the no-treatment group ( p  = 0.002). Further analysis shows that the International Federation of Gynecology and Obstetrics (FIGO) classification type and the use of anti-adhesive gels are independent factors associated with moderate and severe degrees of IUA formation. The results here highlight the significant therapeutic benefits of the application of hyaluronic acid gels in women undergoing a hysteroscopic myomectomy, especially for those patients with a uterine myoma classified as FIGO type 2. Since the risk of IUA after a hysteroscopic myomectomy is high, especially for patients who have not received prophylactic anti-adhesive gels, the application of hyaluronic acid gels as a prevention strategy is highly recommended. More studies are encouraged to confirm our observation.",2020,"Women treated with hyaluronic acid gels have a statistically significantly lower incidence of IUAs than non-treated women (12.8% vs. 39.1%,  p  = 0.012).","['women undergoing a', 'Women with Submucosal Myomas', 'A total of 70 patients were analyzed at the end of 16 March 2020']","['hysteroscopic myomectomy', 'Crosslinked Hyaluronic Acid Gels', 'hyaluronic acid gels', 'hyaluronic acid', 'Hysteroscopic Myomectomy']","['severity of IUA', 'incidence of IUAs', 'Intrauterine adhesion (IUA), fibrosis, and scarring', 'incidence of IUA']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1515025', 'cui_str': 'Submucosal route'}, {'cui': 'C0027086', 'cui_str': 'Myoma'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0195309', 'cui_str': 'Uterine myomectomy'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0241593', 'cui_str': 'Adhesions of uterus'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}]",70.0,0.0977777,"Women treated with hyaluronic acid gels have a statistically significantly lower incidence of IUAs than non-treated women (12.8% vs. 39.1%,  p  = 0.012).","[{'ForeName': 'Chen-Yu', 'Initials': 'CY', 'LastName': 'Huang', 'Affiliation': 'Department of Obstetrics and Gynecology, Taipei Veterans General Hospital, Taipei 112, Taiwan.'}, {'ForeName': 'Wen-Hsun', 'Initials': 'WH', 'LastName': 'Chang', 'Affiliation': 'Department of Obstetrics and Gynecology, Taipei Veterans General Hospital, Taipei 112, Taiwan.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Cheng', 'Affiliation': 'Department of Obstetrics and Gynecology, Taipei Veterans General Hospital, Taipei 112, Taiwan.'}, {'ForeName': 'Hsin-Yi', 'Initials': 'HY', 'LastName': 'Huang', 'Affiliation': 'Biostatics Task Force, Taipei Veterans General Hospital, Taipei 112, Taiwan.'}, {'ForeName': 'Huann-Cheng', 'Initials': 'HC', 'LastName': 'Horng', 'Affiliation': 'Department of Obstetrics and Gynecology, Taipei Veterans General Hospital, Taipei 112, Taiwan.'}, {'ForeName': 'Yi-Jen', 'Initials': 'YJ', 'LastName': 'Chen', 'Affiliation': 'Department of Obstetrics and Gynecology, Taipei Veterans General Hospital, Taipei 112, Taiwan.'}, {'ForeName': 'Wen-Ling', 'Initials': 'WL', 'LastName': 'Lee', 'Affiliation': 'Institute of Clinical Medicine, National Yang-Ming University, Taipei 112, Taiwan.'}, {'ForeName': 'Peng-Hui', 'Initials': 'PH', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynecology, Taipei Veterans General Hospital, Taipei 112, Taiwan.'}]","Life (Basel, Switzerland)",['10.3390/life10050067']
1839,32429429,Effect of Cod Residual Protein Supplementation on Markers of Glucose Regulation in Lean Adults: A Randomized Double-Blind Study.,"Large quantities of protein-rich cod residuals, which are currently discarded, could be utilized for human consumption. Although fish fillet intake is related to beneficial health effects, little is known about the potential health effects of consuming cod residual protein powder. Fifty lean adults were randomized to consume capsules with 8.1 g/day of cod residual protein (Cod-RP) or placebo capsules (Control group) for eight weeks, in this randomized, double-blind study. The intervention was completed by 40 participants. Fasting glucose and insulin concentrations were unaffected by Cod-RP supplementation, whereas plasma concentrations of α-hydroxybutyrate, β-hydroxybutyrate and acetoacetate all were decreased compared with the Control group. Trimethylamine N-oxide concentration in plasma and urine were increased in the Cod-RP group compared with the Control group. To conclude, the reduction in these potential early markers of impaired glucose metabolism following Cod-RP supplementation may indicate beneficial glucoregulatory effects of cod residual proteins. Trimethylamine N-oxide appears to be an appropriate biomarker of cod residual protein intake in lean adults.",2020,Trimethylamine N-oxide concentration in plasma and urine were increased in the Cod-RP group compared with the Control group.,"['Lean Adults', 'lean adults', 'Fifty lean adults']","['Cod Residual Protein Supplementation', 'consume capsules with 8.1 g/day of cod residual protein (Cod-RP) or placebo capsules (Control group', 'Cod-RP supplementation', 'Trimethylamine N-oxide']","['Trimethylamine N-oxide concentration in plasma and urine', 'Markers of Glucose Regulation', 'Fasting glucose and insulin concentrations', 'plasma concentrations of α-hydroxybutyrate, β-hydroxybutyrate and acetoacetate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}]","[{'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}, {'cui': 'C0000988', 'cui_str': 'Acetoacetates'}]",50.0,0.188971,Trimethylamine N-oxide concentration in plasma and urine were increased in the Cod-RP group compared with the Control group.,"[{'ForeName': 'Iselin', 'Initials': 'I', 'LastName': 'Vildmyren', 'Affiliation': 'Dietary Protein Research Group, Department of Clinical Medicine, University of Bergen, 5021 Bergen, Norway.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Halstensen', 'Affiliation': 'K. Halstensen AS, P.O. Box 103, 5399 Bekkjarvik, Norway.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'McCann', 'Affiliation': 'Bevital AS, Jonas Lies veg 87, 5021 Bergen, Norway.'}, {'ForeName': 'Øivind', 'Initials': 'Ø', 'LastName': 'Midttun', 'Affiliation': 'Bevital AS, Jonas Lies veg 87, 5021 Bergen, Norway.'}, {'ForeName': 'Per Magne', 'Initials': 'PM', 'LastName': 'Ueland', 'Affiliation': 'Bevital AS, Jonas Lies veg 87, 5021 Bergen, Norway.'}, {'ForeName': 'Åge', 'Initials': 'Å', 'LastName': 'Oterhals', 'Affiliation': 'Nofima, P.B. 1425 Oasen, 5844 Bergen, Norway.'}, {'ForeName': 'Oddrun Anita', 'Initials': 'OA', 'LastName': 'Gudbrandsen', 'Affiliation': 'Dietary Protein Research Group, Department of Clinical Medicine, University of Bergen, 5021 Bergen, Norway.'}]",Nutrients,['10.3390/nu12051445']
1840,32429069,Effect of a Short Message Service Intervention on Excessive Gestational Weight Gain in a Low-Income Population: A Randomized Controlled Trial.,"OBJECTIVES


The objective of this trial was to investigate the effect of educational short message service (SMS), or text messages, on excessive gestational weight gain (GWG) in a low-income, predominantly overweight/obese population.
METHODS


Participants ( n  = 83) were mostly overweight/obese women recruited at Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) clinics on the island of O'ahu, Hawai'i at 15-20 weeks gestational age. The intervention group received SMS on nutrition and physical activity during pregnancy designed to help them meet Institute of Medicine (IOM) guidelines for GWG and American College of Obstetricians and Gynecologists guidelines for exercise, respectively. The control group received SMS about general health topics during pregnancy, excluding nutrition and physical activity. Both groups received one text message per week for eighteen weeks. GWG was defined as the difference between the last self-reported weight taken before delivery and participants' self-reported weight before pregnancy. Differences between study groups were examined using t-tests and Chi-square tests. Linear regression models were used to examine association of GWG with study group and other factors.
RESULTS


GWG was similar ( p  = 0.58) in the control group (14.1 ± 11.4 kg) and the intervention group (15.5 ± 11.6 kg). The percentage of participants exceeding IOM guidelines for GWG was similar ( p  = 0.51) in the control group (50.0%,  n  = 17) and the intervention group (60.5%,  n  = 23).
CONCLUSIONS


GWG was not significantly different between intervention and control groups. Trials that begin earlier in pregnancy or before pregnancy with longer intervention durations and varying message frequency as well as personalized or interactive messages may be needed to produce significant improvements.",2020,"The percentage of participants exceeding IOM guidelines for GWG was similar ( p  = 0.51) in the control group (50.0%,  n  = 17) and the intervention group (60.5%,  n  = 23).
","['Participants ( n  = 83) were mostly overweight/obese women recruited at', 'low-income, predominantly overweight/obese population', ""for Women, Infants, and Children (WIC) clinics on the island of O'ahu, Hawai'i at 15-20 weeks gestational age"", 'a Low-Income Population']","['SMS', 'Short Message Service Intervention', 'educational short message service (SMS), or text messages', 'SMS on nutrition and physical activity during pregnancy designed to help them meet Institute of Medicine (IOM) guidelines for GWG', 'Special Supplemental Nutrition Program']","['Excessive Gestational Weight Gain', 'excessive gestational weight gain (GWG']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0022130', 'cui_str': 'Island'}, {'cui': 'C0455000', 'cui_str': 'Oahu'}, {'cui': 'C0018619', 'cui_str': 'Hawaii state'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0024045', 'cui_str': 'Low Income Population'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0021621', 'cui_str': 'Institute of Medicine (U.S.)'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}]",83.0,0.0572663,"The percentage of participants exceeding IOM guidelines for GWG was similar ( p  = 0.51) in the control group (50.0%,  n  = 17) and the intervention group (60.5%,  n  = 23).
","[{'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Holmes', 'Affiliation': 'Department of Human Nutrition, Food and Animal Sciences, College of Tropical Agriculture and Human Resources, University of Hawaii at Manoa, Honolulu, HI 96822, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Palacios', 'Affiliation': 'Department of Dietetics and Nutrition, Stempel College of Public Health and Social Work, Florida International University, Miami, FL 33199, USA.'}, {'ForeName': 'YanYan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Office of Public Health Studies, University of Hawaii at Manoa, Honolulu, HI 96822, USA.'}, {'ForeName': 'Jinan', 'Initials': 'J', 'LastName': 'Banna', 'Affiliation': 'Department of Human Nutrition, Food and Animal Sciences, College of Tropical Agriculture and Human Resources, University of Hawaii at Manoa, Honolulu, HI 96822, USA.'}]",Nutrients,['10.3390/nu12051428']
1841,32429481,Iron Status of Burkinabé Adolescent Girls Predicts Malaria Risk in the Following Rainy Season.,"High levels of storage iron may increase malaria susceptibility. This risk has not been investigated in semi-immune adolescents. We investigated whether baseline iron status of non-pregnant adolescent girls living in a high malaria transmission area in Burkina Faso affected malaria risk during the following rainy season. For this prospective study, we analysed data from an interim safety survey, conducted six months into a randomised iron supplementation trial. We used logistic regression to model the risk of  P. falciparum  infection prevalence by microscopy, the pre-specified interim safety outcome, in relation to iron status, nutritional indicators and menarche assessed at recruitment. The interim survey was attended by 1223 (82%) of 1486 eligible participants, 1084 (89%) of whom were <20 years at baseline and 242 (22%) were pre-menarcheal. At baseline, prevalence of low body iron stores was 10%. At follow-up, 38% of adolescents had predominantly asymptomatic malaria parasitaemias, with no difference by menarcheal status. Higher body iron stores at baseline predicted an increased malaria risk in the following rainy season (OR 1.18 (95% CI 1.05, 1.34,  p  = 0.007) after adjusting for bed net use, age, menarche, and body mass index. We conclude that routine iron supplementation should not be recommended without prior effective malaria control.",2020,"At follow-up, 38% of adolescents had predominantly asymptomatic malaria parasitaemias, with no difference by menarcheal status.","['The interim survey was attended by 1223 (82%) of 1486 eligible participants, 1084 (89%) of whom were <20 years at baseline and 242 (22%) were pre-menarcheal', 'non-pregnant adolescent girls living in a high malaria transmission area in Burkina Faso affected malaria risk during the following rainy season']",['routine iron supplementation'],"['asymptomatic malaria parasitaemias', 'prevalence of low body iron stores', 'Higher body iron stores', 'malaria risk', 'Malaria Risk']","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0006409', 'cui_str': 'Burkina Faso'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}]","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0450235', 'cui_str': 'Evaluation of iron stores'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",1486.0,0.150127,"At follow-up, 38% of adolescents had predominantly asymptomatic malaria parasitaemias, with no difference by menarcheal status.","[{'ForeName': 'Loretta', 'Initials': 'L', 'LastName': 'Brabin', 'Affiliation': 'Division of Population Health, Health Services Research and Primary Care, University of Manchester, Oxford Road, Manchester M13 9PL, UK.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Roberts', 'Affiliation': 'Division of Population Health, Health Services Research and Primary Care, University of Manchester, Oxford Road, Manchester M13 9PL, UK.'}, {'ForeName': 'Halidou', 'Initials': 'H', 'LastName': 'Tinto', 'Affiliation': 'Clinical Research Unit of Nanoro, (IRSS-URCN), B.P.218 Ouagadougou 11, Burkina Faso.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Gies', 'Affiliation': 'Department of Biomedical Sciences, Prince Leopold Institute of Tropical Medicine, Antwerp, Belgium and Medical Mission Institute, 97074 Würzburg, Germany.'}, {'ForeName': 'Salou', 'Initials': 'S', 'LastName': 'Diallo', 'Affiliation': 'Clinical Research Unit of Nanoro, (IRSS-URCN), B.P.218 Ouagadougou 11, Burkina Faso.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Brabin', 'Affiliation': 'Liverpool School of Tropical Medicine and Institute of Infection and Global Health, University of Liverpool, Liverpool, UK.'}]",Nutrients,['10.3390/nu12051446']
1842,32429379,"The Effect of a Family-Based Lifestyle Education Program on Dietary Habits, Hepatic Fat and Adiposity Markers in 8-12-Year-Old Children with Overweight/Obesity.","Healthy lifestyle education programs are recommended for obesity prevention and treatment. However, there is no previous information on the effects of these programs on the reduction of hepatic fat percentage. The aims were (i) to examine the effectiveness of a 22-week family-based lifestyle education program on dietary habits, and (ii) to explore the associations of changes in dietary intake with percent hepatic fat reduction and adiposity in children with overweight/obesity. A total of 81 children with overweight/obesity (aged 10.6 ± 1.1 years, 53.1% girls) and their parents attended a 22-week family based healthy lifestyle and psychoeducational program accompanied with (intensive group) or without (control) an exercise program. Hepatic fat (magnetic resonance imaging), adiposity (dual energy X-ray absorptiometry) and dietary habits (two non-consecutive 24 h-recalls) were assessed before and after the intervention. Energy ( p  < 0.01) fat ( p  < 0.01) and added sugar ( p  < 0.03) intake were significantly reduced in both groups at the end of the program, while, in addition, carbohydrates intake ( p  < 0.04) was reduced exclusively in the control group, and simple sugar ( p  < 0.05) and cholesterol ( p  < 0.03) intake was reduced in the exercise group. Fruit ( p  < 0.03) and low-fat/skimmed dairy consumption ( p  < 0.02), the adherence to the Mediterranean Diet Quality Index for children and teenagers (KIDMED,  p  < 0.01) and breakfast quality index ( p  < 0.03) were significantly higher in both control and intervention groups after the intervention. Moreover, participants in the exercise group increased the adherence to the Dietary Approaches to Stop Hypertension (DASH) diet ( p  < 0.001), whereas the ratio of evening-morning energy intake was significantly lower exclusively in the control group after the program ( p  < 0.02). Changes in energy intake were significantly associated with changes in fat mass index (FMI) in the exercise group, whereas changes in sugar-sweetened beverages (SSB) consumption was associated with percent hepatic fat reduction ( p  < 0.05) in the control group. A 22-week family-based healthy lifestyle program seems to be effective on improving diet quality and health in children with overweight/obesity and these should focus on SSB avoidance and physical activity.",2020,"p  < 0.02), the adherence to the Mediterranean Diet Quality Index for children and teenagers (KIDMED,  ","['81 children with overweight/obesity (aged 10.6 ± 1.1 years, 53.1% girls) and their parents attended a 22-week family based healthy lifestyle and', '8-12-Year-Old Children with Overweight/Obesity', 'children with overweight/obesity']","['22-week family-based lifestyle education program', 'added sugar ', 'psychoeducational program accompanied with (intensive group) or without (control) an exercise program', 'Family-Based Lifestyle Education Program']","['adherence to the Dietary Approaches to Stop Hypertension (DASH) diet', 'adherence to the Mediterranean Diet Quality Index', 'ratio of evening-morning energy intake', 'fat mass index (FMI', 'cholesterol', 'breakfast quality index', 'changes in sugar-sweetened beverages (SSB) consumption', 'diet quality and health', 'Hepatic fat (magnetic resonance imaging), adiposity (dual energy X-ray absorptiometry) and dietary habits', 'carbohydrates intake', 'Dietary Habits, Hepatic Fat and Adiposity Markers', 'hepatic fat reduction', 'energy intake']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",81.0,0.0124975,"p  < 0.02), the adherence to the Mediterranean Diet Quality Index for children and teenagers (KIDMED,  ","[{'ForeName': 'Lide', 'Initials': 'L', 'LastName': 'Arenaza', 'Affiliation': 'Institute for Innovation and Sustainable Development in Food Chain (IS-FOOD), Public University of Navarra, Calle Tajonar 22, 31006 Pamplona, Navarra, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Medrano', 'Affiliation': 'Institute for Innovation and Sustainable Development in Food Chain (IS-FOOD), Public University of Navarra, Calle Tajonar 22, 31006 Pamplona, Navarra, Spain.'}, {'ForeName': 'Maddi', 'Initials': 'M', 'LastName': 'Oses', 'Affiliation': 'Institute for Innovation and Sustainable Development in Food Chain (IS-FOOD), Public University of Navarra, Calle Tajonar 22, 31006 Pamplona, Navarra, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Amasene', 'Affiliation': 'Department of Pharmacy and Food Sciences, University of the Basque Country, UPV/EHU, 01006 Vitoria-Gasteiz, Araba, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Díez', 'Affiliation': 'Pediatric Endocrinology Unit, University Hospital of Araba (HUA), 01009 Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Rodríguez-Vigil', 'Affiliation': 'Department of Magnetic Resonance Imaging, Osatek, University Hospital of Araba (HUA), 01009 Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Idoia', 'Initials': 'I', 'LastName': 'Labayen', 'Affiliation': 'Institute for Innovation and Sustainable Development in Food Chain (IS-FOOD), Public University of Navarra, Calle Tajonar 22, 31006 Pamplona, Navarra, Spain.'}]",Nutrients,['10.3390/nu12051443']
1843,32434813,"Correction:  Efficacy and safety of ixekizumab through 52 weeks in two phase 3, randomised, controlled clinical trials in patients with active radiographic axial spondyloarthritis (COAST-V and COAST-W) .",,2020,,['patients with active radiographic axial spondyloarthritis (COAST-V and COAST-W) '],['ixekizumab'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}]",[],,0.135237,,[],Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216118corr1']
1844,31518424,Supplemental 25-Hydroxycholecalciferol Is More Effective than Cholecalciferol in Raising Serum 25-Hydroxyvitamin D Concentrations in Older Adults.,"BACKGROUND


There are few studies directly comparing the pharmacokinetics of 25-hydroxycholecalciferol [25(OH)D3] to cholecalciferol (D3).
OBJECTIVES


The primary objectives were to compare the effectiveness of D3 and 25(OH)D3 in raising 25-hydroxyvitamin D [25(OH)D] serum concentrations and achieving steady state.
METHODS


This was a randomized, double-blind, active comparator trial of 91 participants (53 females, 38 males), aged 63.3 ± 7.9 y. 25(OH)D3 (10, 15, and 20 µg) and D3 (20 µg) were dosed daily for 6 mo followed by 6 mo of washout. Frequent measurements of serum 25(OH)D were performed. Pharmacokinetic parameters were fitted for each individual and the treatment average was modeled with linear regression using the individual baseline level, sex, and gender as covariates.
RESULTS


Mean baseline 25(OH)D was similar in all groups (47.1-49.5 nmol/L). Increases in 25(OH)D to steady state were higher in the 25(OH)D3 groups than in the D3 group [least squares (LS) means (95% CI): 50.1 (43.3-58.0), 72.5 (64.3-81.7), 97.4 (86.6-109.6) nmol/L in 10, 15, and 20 µg/d and 38.7 (33.1-45.2) nmol/L in the D3 group; P = 0.0173, P < 0.0001, P < 0.0001]. The rate to reach steady state was similar in all groups, but the time to reach 25(OH)D concentrations of 75 nmol/L was faster in the higher-dosed 25(OH)D3 groups than in the D3 group (7 and 10 d compared with 40 d, P < 0.0001 and P < 0.0001 for 15 and 20 µg/d). The rate of elimination was 59-109% higher in the 25(OH)D3 groups than in the D3 group. The area under the curve (AUC)/µg dose demonstrated that 25(OH)D3 was 3 times as effective as D3 at raising 25(OH)D concentrations.
CONCLUSIONS


25(OH)D3 is ∼3 times as effective as D3 at raising 25(OH)D concentrations. Once supplementation is discontinued, the elimination rate of 25(OH)D3 is faster than D3. This trial was registered at clinicaltrials.gov as NCT02333682.",2020,"The rate to reach steady state was similar in all groups, but the time to reach 25(OH)D concentrations of 75 nmol/L was faster in the higher-dosed 25(OH)D3 groups than in the D3 group (7 and 10 d compared with 40 d, P < 0.0001 and P < 0.0001 for 15 and 20 µg/d).","['Older Adults', '91 participants (53 females, 38 males), aged 63.3\xa0±\xa07.9 y. 25(OH)D3']","['Supplemental 25-Hydroxycholecalciferol', 'Cholecalciferol', 'cholecalciferol (D3']","['rate to reach steady state', 'elimination rate of 25(OH)D3', '25(OH)D to steady state', 'rate of elimination', 'Serum 25-Hydroxyvitamin D Concentrations', 'time to reach 25(OH)D concentrations', 'effectiveness of D3 and 25(OH)D3 in raising 25-hydroxyvitamin D [25(OH)D] serum concentrations and achieving steady state']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0242215', 'cui_str': 'Cholecalciferols'}]","[{'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0442818', 'cui_str': 'Raised (qualifier value)'}]",91.0,0.0354574,"The rate to reach steady state was similar in all groups, but the time to reach 25(OH)D concentrations of 75 nmol/L was faster in the higher-dosed 25(OH)D3 groups than in the D3 group (7 and 10 d compared with 40 d, P < 0.0001 and P < 0.0001 for 15 and 20 µg/d).","[{'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Graeff-Armas', 'Affiliation': 'Department of Diabetes, Endocrinology, and Metabolism, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Bendik', 'Affiliation': 'DSM Nutritional Products Ltd., Human Nutrition and Health, Basel, Switzerland.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Kunz', 'Affiliation': 'DSM Nutritional Products Ltd., Human Nutrition and Health, Basel, Switzerland.'}, {'ForeName': 'Rotraut', 'Initials': 'R', 'LastName': 'Schoop', 'Affiliation': 'DSM Nutritional Products Ltd., Human Nutrition and Health, Basel, Switzerland.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hull', 'Affiliation': 'Leatherhead Food Research, Surrey, United Kingom.'}, {'ForeName': 'Mareike', 'Initials': 'M', 'LastName': 'Beck', 'Affiliation': 'DSM Nutritional Products Ltd., Human Nutrition and Health, Basel, Switzerland.'}]",The Journal of nutrition,['10.1093/jn/nxz209']
1845,31517964,Effect of a Prize-Linked Savings Intervention on Savings and Healthy Behaviors Among Men in Kenya: A Randomized Clinical Trial.,"Importance


Interventions to reduce men's alcohol use and risky sexual behaviors are essential for reducing new HIV infections in high-prevalence settings in sub-Saharan Africa. Prize-linked savings accounts can motivate savings and may decrease expenditures on risky behaviors, but few studies have examined the HIV prevention potential of such savings interventions among men.
Objective


To evaluate the effect of prize-linked savings accounts on savings behavior and expenditures on alcohol, gambling, and transactional sex among men in Kenya.
Design, Setting, and Participants


Randomized clinical trial among communities in Siaya County, Kenya. Participants were men 21 years or older who owned a mobile phone, were engaged in fishing or transportation sector work, and were willing to open an account with a local bank; they were screened for eligibility between September 3 and October 5, 2018.
Interventions


Eligible participants were offered savings accounts endowed with 1000 Kenya shillings (US $10) and randomized (1:1) to receive weekly lottery-based rewards contingent on growth in savings balance or to a control group that received standard interest.
Main Outcomes and Measures


The primary outcome was an indicator of whether a participant saved any money in the bank account (intent-to-treat analysis) during the study period. Secondary outcomes included total amount saved in the bank account, total amount saved in all sources, and expenditures on alcohol, gambling, and transactional sex.
Results


A total of 425 men were screened, 329 (77.4%) met eligibility criteria, 300 (70.6%) were enrolled (with 152 randomized to the intervention group and 148 to the control group), and 270 of 300 (90.0%) opened bank accounts. Participants' mean age was 33.7 years (interquartile range, 13.5 years), 84.3% (253 of 300) were married, and the mean weekly earnings were US $30 (interquartile range, US $23). During a mean (SD) follow-up of 9 (2) weeks, 37.3% (50 of 134) in the intervention group saved money in a bank account vs 27.2% (37 of 136) in the control group, although the difference was not statistically significant (odds ratio, 1.62; 95% CI, 0.96-2.74). The intervention group had higher growth in bank savings balances (US $10.26; 95% CI, US $5.00-US $58.20 vs US $4.87; 95% CI, US $0.67-US $9.00) and higher total savings from all sources (US $201; 95% CI, US $133-US $269 vs US $145; 95% CI, US $88-US $202), but neither difference was statistically significant. The intervention did not have a significant effect on alcohol, gambling, and transactional sex expenditures.
Conclusions and Relevance


Prize-linked savings accounts modestly increased savings among high-risk men in Kenya over a 9-week period, but the difference compared with standard-interest savings accounts was not significant. Testing of more powerful savings products is needed to assess whether such savings-led interventions can reduce men's expenditures on alcohol, gambling, and transactional sex.
Trial Registration


Social Science Registry identifier: AEARCTR-0003224, and ClinicalTrials.gov identifier: NCT04013295.",2019,"The intervention group had higher growth in bank savings balances (US $10.26; 95% CI, US $5.00-US $58.20 vs US $4.87; 95% CI, US $0.67-US $9.00) and higher total savings from all sources (US $201; 95% CI, US $133-US $269 vs US $145; 95% CI, US $88-US $202), but neither difference was statistically significant.","[""Participants' mean age was 33.7 years (interquartile range, 13.5 years), 84.3% (253 of 300) were married, and the mean weekly earnings were US $30 (interquartile range, US $23"", 'A total of 425 men were screened, 329 (77.4%) met eligibility criteria, 300 (70.6%) were enrolled (with 152 randomized to the intervention group and 148 to the control group), and 270 of 300 (90.0%) opened bank accounts', 'Participants were men 21 years or older who owned a mobile phone, were engaged in fishing or transportation sector work, and were willing to open an account with a local bank; they were screened for eligibility between September 3 and October 5, 2018', 'men', 'Men in Kenya', 'communities in Siaya County, Kenya', 'men in Kenya']","['prize-linked savings', 'weekly lottery-based rewards contingent on growth in savings balance or to a control group that received standard interest', 'Prize-Linked Savings Intervention']","['total amount saved in the bank account, total amount saved in all sources, and expenditures on alcohol, gambling, and transactional sex', 'higher growth in bank savings balances', 'indicator of whether a participant saved any money in the bank account (intent-to-treat analysis', 'Savings and Healthy Behaviors', 'total savings', 'alcohol, gambling, and transactional sex expenditures', 'savings behavior and expenditures on alcohol, gambling, and transactional sex']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517559', 'cui_str': '13.5 (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3844105', 'cui_str': '425 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C4042872', 'cui_str': 'Bank Accounts'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0442598', 'cui_str': 'Bank (environment)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0080049', 'cui_str': 'Prizes'}, {'cui': 'C0036245', 'cui_str': 'Savings'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4042872', 'cui_str': 'Bank Accounts'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0442598', 'cui_str': 'Bank (environment)'}, {'cui': 'C0036245', 'cui_str': 'Savings'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",425.0,0.0919333,"The intervention group had higher growth in bank savings balances (US $10.26; 95% CI, US $5.00-US $58.20 vs US $4.87; 95% CI, US $0.67-US $9.00) and higher total savings from all sources (US $201; 95% CI, US $133-US $269 vs US $145; 95% CI, US $88-US $202), but neither difference was statistically significant.","[{'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Moscoe', 'Affiliation': 'Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Kawango', 'Initials': 'K', 'LastName': 'Agot', 'Affiliation': 'Impact Research and Development Organization, Kisumu, Kenya.'}, {'ForeName': 'Harsha', 'Initials': 'H', 'LastName': 'Thirumurthy', 'Affiliation': 'Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.11162']
1846,31283740,Superior Trunk Block: A Phrenic-sparing Alternative to the Interscalene Block: A Randomized Controlled Trial.,"BACKGROUND


Interscalene nerve blockade remains one of the most commonly used anesthetic and analgesic approaches for shoulder surgery. The high incidence of hemidiaphragmatic paralysis associated with the block, however, precludes its use among patients with compromised pulmonary function. To address this issue, recent studies have investigated phrenic-sparing alternatives that provide analgesia. None, however, have been able to reliably demonstrate surgical anesthesia without significant risk for hemidiaphragmatic paralysis. The utility of the superior trunk block has yet to be studied. The hypothesis was that compared with the interscalene block, the superior trunk block will provide noninferior surgical anesthesia and analgesia while sparing the phrenic nerve.
METHODS


This randomized controlled trial included 126 patients undergoing arthroscopic ambulatory shoulder surgery. Patients either received a superior trunk block (n = 63) or an interscalene block (n = 63). The primary outcomes were the incidence of hemidiaphragmatic paralysis and worst pain score in the recovery room. Ultrasound was used to assess for hemidiaphragmatic paralysis. Secondary outcomes included noninvasively measured parameters of respiratory function, opioid consumption, handgrip strength, adverse effects, and patient satisfaction.
RESULTS


The superior trunk group had a significantly lower incidence of hemidiaphragmatic paralysis compared with the interscalene group (3 of 62 [4.8%] vs. 45 of 63 [71.4%]; P < 0.001, adjusted odds ratio 0.02 [95% CI, 0.01, 0.07]), whereas the worst pain scores in the recovery room were noninferior (0 [0, 2] vs. 0 [0, 3]; P = 0.951). The superior trunk group were more satisfied, had unaffected respiratory parameters, and had a lower incidence of hoarseness. No difference in handgrip strength or opioid consumption were detected. Superior trunk block was associated with lower worst pain scores on postoperative day 1.
CONCLUSIONS


Compared with the interscalene block, the superior trunk block provides noninferior surgical anesthesia while preserving diaphragmatic function. The superior trunk block may therefore be considered an alternative to traditional interscalene block for shoulder surgery.",2019,"The superior trunk group had a significantly lower incidence of hemidiaphragmatic paralysis compared with the interscalene group (3 of 62 [4.8%] vs. 45 of 63 [71.4%]; P < 0.001, adjusted odds ratio 0.02","['126 patients undergoing arthroscopic ambulatory shoulder surgery', 'hemidiaphragmatic paralysis', 'patients with compromised pulmonary function']","['interscalene block', 'Superior Trunk Block', 'Phrenic-sparing Alternative to the Interscalene Block', 'superior trunk block']","['incidence of hemidiaphragmatic paralysis and worst pain score', 'noninvasively measured parameters of respiratory function, opioid consumption, handgrip strength, adverse effects, and patient satisfaction', 'hemidiaphragmatic paralysis', 'worst pain scores', 'handgrip strength or opioid consumption', 'incidence of hoarseness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0522224', 'cui_str': 'Plegia'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}]","[{'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach (procedure)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0522224', 'cui_str': 'Plegia'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0019825', 'cui_str': 'Voice Hoarseness'}]",126.0,0.114619,"The superior trunk group had a significantly lower incidence of hemidiaphragmatic paralysis compared with the interscalene group (3 of 62 [4.8%] vs. 45 of 63 [71.4%]; P < 0.001, adjusted odds ratio 0.02","[{'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'From the Departments of Anesthesiology (D.H.K., Y.L., J.C.B., J.L., J.A.O., S.C.H., M.C.H., D.S.W., L.W., C.G., S.G.M.) Orthopedic Surgery (A.A.A.), Hospital for Special Surgery, New York, New York.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Beathe', 'Affiliation': ''}, {'ForeName': 'Jiabin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Oxendine', 'Affiliation': ''}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Haskins', 'Affiliation': ''}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Ho', 'Affiliation': ''}, {'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Wetmore', 'Affiliation': ''}, {'ForeName': 'Answorth A', 'Initials': 'AA', 'LastName': 'Allen', 'Affiliation': ''}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Wilson', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Garnett', 'Affiliation': ''}, {'ForeName': 'Stavros G', 'Initials': 'SG', 'LastName': 'Memtsoudis', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000002841']
1847,31479032,The effects of testosterone administration on muscle areas of the trunk and pelvic floor in hysterectomized women with low testosterone levels: proof-of-concept study.,"OBJECTIVE


The aim of this study was to determine the effect of testosterone administration on trunk and pelvic floor muscle area in women with low testosterone levels.
METHODS


Participants were hysterectomized women with total testosterone<31 ng/dL and/or free testosterone<3.5 pg/mL; participating in the Testosterone Dose Response in Surgically Menopausal Women (TDSM) trial. All participants received a standardized transdermal estradiol regimen during the 12-week run-in period, and were then randomized to receive weekly intramuscular injections of placebo, or 3, 6.25, 12.5, or 25 mg testosterone enanthate for 24 weeks. Muscle areas of the trunk and pelvis were measured at baseline and end of treatment using 1.5 Tesla magnetic resonance imaging. Total and free testosterone levels were measured by liquid chromatography-tandem mass spectrometry and equilibrium dialysis, respectively. Testosterone effect on muscle areas was analyzed using linear regression models.
RESULTS


A total of 24 women who had available baseline and posttreatment magnetic resonance imaging were included in the analysis. Increased cross-sectional areas of the paraspinal, psoas, and abdominal wall muscles were seen after testosterone administration. The estimated mean change (95% CI; P value) between treatment groups was 4.07 cm (1.26-6.88; P = 0.007) for paraspinal, 1.60 cm (0.10-3.09; P = 0.038) for psoas major, and 7.49 cm (1.96-13.02; P = 0.011) for abdominal wall muscles. Increases in psoas muscle area were significantly associated with changes in free testosterone concentrations. No significant changes in obturator internus and pelvic floor muscle areas were observed.
CONCLUSION


Short-term testosterone administration in women with low testosterone levels was associated with increased trunk muscle area.",2019,"Increased cross-sectional areas of the paraspinal, psoas, and abdominal wall muscles were seen after testosterone administration.","['Participants were hysterectomized women with total testosterone<31 ng/dL', 'women with low testosterone levels', 'Surgically Menopausal Women (TDSM) trial', 'hysterectomized women with low testosterone levels', '24 women who had available baseline and posttreatment magnetic resonance imaging were included in the analysis']","['standardized transdermal estradiol regimen', 'placebo', 'testosterone enanthate', 'Testosterone', 'testosterone']","['Total and free testosterone levels', 'obturator internus and pelvic floor muscle areas', 'free testosterone concentrations', 'psoas muscle area']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439274', 'cui_str': 'ng/dL'}, {'cui': 'C1295654', 'cui_str': 'Decreased testosterone level'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0076189', 'cui_str': 'testosterone enanthate'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0443483', 'cui_str': 'Free testosterone (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0224422', 'cui_str': 'Internal obturator muscle structure'}, {'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0085221', 'cui_str': 'Psoas Muscles'}]",,0.371009,"Increased cross-sectional areas of the paraspinal, psoas, and abdominal wall muscles were seen after testosterone administration.","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Tapper', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Huang', 'Affiliation': ""Research Program in Men's Health, Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Karol M', 'Initials': 'KM', 'LastName': 'Pencina', 'Affiliation': ""Research Program in Men's Health, Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Zhuoying', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Research Program in Men's Health, Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Arver', 'Affiliation': 'Department of Medicine, Centre for Andrology and Sexual Medicine, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Martling', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Blomqvist', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Buchli', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Travison', 'Affiliation': 'Program on Ageing, Hebrew Senior Life, Roslindale, MA.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Storer', 'Affiliation': ""Research Program in Men's Health, Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Shalender', 'Initials': 'S', 'LastName': 'Bhasin', 'Affiliation': ""Research Program in Men's Health, Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Shehzad', 'Initials': 'S', 'LastName': 'Basaria', 'Affiliation': ""Research Program in Men's Health, Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001410']
1848,31845149,"Age- and Race/Ethnicity-Specific Sex Partner Correlates of Condomless Sex in an Online Sample of Hispanic/Latino, Black/African-American, and White Men Who Have Sex with Men.","We sought to identify and compare correlates of condomless receptive anal intercourse with HIV-positive or unknown status partners (CRAI) for younger (< 25 years) and older (≥ 25 years) Hispanic/Latino, black/African-American, and white men who have sex with men (MSM). Baseline data from the Evaluation of Rapid HIV Self-Testing among MSM Project (eSTAMP), a randomized controlled trial with MSM (n = 2665, analytical sample size = 2421), were used. Potential correlates included participants' sociodemographic characteristics and HIV status as well as the characteristics of participants' partners. Younger Hispanic/Latino and black men were most likely to report having older sex partners (≥ 50% of partners being at least 5 years older), and having older partners was a significant correlate of CRAI among younger Hispanic/Latino and white men. Regardless of race/ethnicity, not knowing one's HIV status was a significant correlate of CRAI among younger men, whereas having a black sex partner was a significant correlate among older men. HIV prevention initiatives could address these and other correlates specific to race/ethnicity groups to target their prevention resources and messaging.",2019,"Regardless of race/ethnicity, not knowing one's HIV status was a significant correlate of CRAI among younger men, whereas having a black sex partner was a significant correlate among older men.","['Hispanic/Latino, black/African-American, and white men who have sex with men (MSM', 'condomless receptive anal intercourse with HIV-positive or unknown status partners (CRAI) for younger (<\u200925\xa0years) and older (≥\u200925\xa0years', 'Younger Hispanic/Latino and black men', 'Age- and Race/Ethnicity-Specific Sex Partner Correlates of Condomless Sex in an Online Sample of Hispanic/Latino, Black/African-American, and White Men', 'n\u2009=\u20092665, analytical sample size\u2009=\u20092421', 'Who Have Sex with Men']","['MSM', 'MSM Project (eSTAMP']",[],"[{'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0556628', 'cui_str': 'Anal penetration (finding)'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}]",[],[],,0.04104,"Regardless of race/ethnicity, not knowing one's HIV status was a significant correlate of CRAI among younger men, whereas having a black sex partner was a significant correlate among older men.","[{'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Mizuno', 'Affiliation': 'Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, 1600 Clifton Road, NE Mail Stop US8-5, Atlanta, GA, 30329, USA. ymizuno@cdc.gov.'}, {'ForeName': 'Craig B', 'Initials': 'CB', 'LastName': 'Borkowf', 'Affiliation': 'Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, 1600 Clifton Road, NE Mail Stop US8-5, Atlanta, GA, 30329, USA.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Hirshfield', 'Affiliation': 'Department of Medicine, SUNY Downstate Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Mustanski', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Sullivan', 'Affiliation': 'Emory University School of Public Health, Atlanta, GA, USA.'}, {'ForeName': 'Robin J', 'Initials': 'RJ', 'LastName': 'MacGowan', 'Affiliation': 'Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, 1600 Clifton Road, NE Mail Stop US8-5, Atlanta, GA, 30329, USA.'}]",Archives of sexual behavior,['10.1007/s10508-019-01534-8']
1849,31515716,Preschool-Onset Major Depressive Disorder is Characterized by Electrocortical Deficits in Processing Pleasant Emotional Pictures.,"Reductions in positive affect are a salient feature of preschool-onset major depressive disorder. Yet, little is known about the psychophysiological correlates of this blunted positive affect and whether reduced physiological responding to pleasant stimuli may differentiate depressed and healthy young children. 120 four-to-seven year old children with current depression and 63 psychiatrically healthy 4-to-7 year old children completed a simple picture-viewing task of pleasant and neutral pictures while event-related potentials (ERPs) were recorded. The early-childhood version of the Kiddie Schedule for Affective Disorders and Depression was used to establish psychiatric diagnoses. A one-way ANCOVA was used to test for group differences in response to pleasant and neutral pictures. Young children with depression showed a reduced response to pleasant vs. neutral pictures (LPP), after controlling for children's age (F(1,180) = 4.15, p = 0.04, η2 = 0.02). The LPP for the children with preschool-onset depression (M = 0.99, SE = 0.65) was significantly smaller than the LPP in the healthy group of young children (M = 3.27, SE = 0.90). This difference did not vary as a function of depression or anhedonia severity within the group with depression or the healthy children. Similar to older children and adolescents with depression, young children with depression display reductions in responsivity to pleasant stimuli as indexed by the LPP. These findings extend prior findings indicating a blunted response to pleasant stimuli in preschool- onset depression. Given the greater neuroplasticity of emotional response and regulation, these findings suggest clinical attention to emotional response to pleasure is an important target in preschool-onset depression. Clinical trial registration information: A Randomized Control Trial of PCIT-ED for Preschool Depression; http://clinicaltrials.gov/;NCT02076425.",2020,"Young children with depression showed a reduced response to pleasant vs. neutral pictures (LPP), after controlling for children's age (F(1,180) = 4.15, p = 0.04, η2 = 0.02).","['120 four-to-seven year old children with current depression and 63 psychiatrically healthy 4-to-7\xa0year old children completed a', 'Young children with depression', 'healthy young children', 'Preschool-Onset Major Depressive Disorder']","['PCIT-ED', 'simple picture-viewing task of pleasant and neutral pictures while event-related potentials (ERPs']","['reduced response to pleasant vs. neutral pictures (LPP', 'function of depression or anhedonia severity']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0282171', 'cui_str': 'Potentials, Event-Related'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",,0.104051,"Young children with depression showed a reduced response to pleasant vs. neutral pictures (LPP), after controlling for children's age (F(1,180) = 4.15, p = 0.04, η2 = 0.02).","[{'ForeName': 'Diana J', 'Initials': 'DJ', 'LastName': 'Whalen', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine in St. Louis, 4444 Forest Park, Suite 2100, St. Louis, MO, 63108, USA. diana.whalen@wustl.edu.'}, {'ForeName': 'Kirsten E', 'Initials': 'KE', 'LastName': 'Gilbert', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine in St. Louis, 4444 Forest Park, Suite 2100, St. Louis, MO, 63108, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Kelly', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine in St. Louis, 4444 Forest Park, Suite 2100, St. Louis, MO, 63108, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Hajcak', 'Affiliation': 'Department of Psychology, Florida State University, Tallahassee, FL, USA.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Kappenman', 'Affiliation': 'Department of Psychology, San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Joan L', 'Initials': 'JL', 'LastName': 'Luby', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine in St. Louis, 4444 Forest Park, Suite 2100, St. Louis, MO, 63108, USA.'}, {'ForeName': 'Deanna M', 'Initials': 'DM', 'LastName': 'Barch', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine in St. Louis, 4444 Forest Park, Suite 2100, St. Louis, MO, 63108, USA.'}]",Journal of abnormal child psychology,['10.1007/s10802-019-00585-8']
1850,31511891,Recurrent Hemispheric Stroke Syndromes in Symptomatic Atherosclerotic Internal Carotid Artery Occlusions: The Carotid Occlusion Surgery Study Randomized Trial.,"BACKGROUND


There are limited data on outcomes of extracranial-intracranial (EC-IC) bypass in patients with recurrent hemispheric syndromes due to atherosclerotic internal carotid artery occlusion (AICAO).
OBJECTIVE


To compare clinical outcomes and efficacy of EC-IC bypass surgery in patients with and without recurrent hemispheric syndromes associated with AICAO in the Carotid Occlusion Surgery Study (COSS).
METHODS


In patients enrolled in the COSS trial, we compared baseline characteristics and clinical outcomes for participants with (rHEMI+) and without recurrent hemispheric ischemia (rHEMI-) prior to randomization into surgical vs medical groups. The primary outcome was all stroke and death from randomization through 30 d and ipsilateral ischemic stroke within 2 yr.
RESULTS


Of 195 randomized participants, 100 were rHEMI+ (50 in each group). Baseline characteristics between rHEMI+ and rHEMI- participants were similar except rHEMI+ were more likely to have had previous stroke prior to randomization (61% vs 20%, P < .01) and to have TIA as the entry event (59% vs 21%, P < .01). All primary endpoints were ipsilateral ischemic strokes. There were no significant differences in occurrence of the primary endpoint between nonsurgical and surgical participants in rHEMI+ (26.3% vs 22.4%, P = .660) and rHEMI- (18.9% vs 19.5%, P = .943). For nonsurgical participants, there was no significant difference in the primary endpoint for rHEMI+ vs rHEMI- patients (P = .410).
CONCLUSION


Patients with recurrent hemispheric stroke syndromes enrolled in the COSS trial did not show benefit from EC-IC bypass compared to medical treatment. Early aggressive risk factor measures should be prioritized to reduce recurrent strokes in these patients.",2020,"For nonsurgical participants, there was no significant difference in the primary endpoint for rHEMI+ vs rHEMI- patients (P = .410).
","['participants with (rHEMI+) and without recurrent hemispheric ischemia (rHEMI-) prior to randomization into surgical vs medical groups', 'patients with recurrent hemispheric syndromes due to atherosclerotic internal carotid artery occlusion (AICAO', 'patients with and without recurrent hemispheric syndromes associated with AICAO in the Carotid Occlusion Surgery Study (COSS', 'Symptomatic Atherosclerotic Internal Carotid Artery Occlusions', 'Of 195 randomized participants, 100 were rHEMI', 'Patients with recurrent hemispheric stroke syndromes']","['extracranial-intracranial (EC-IC) bypass', 'EC-IC bypass', 'EC-IC bypass surgery']","['recurrent strokes', 'rHEMI', 'ipsilateral ischemic strokes', 'stroke and death from randomization through 30 d and ipsilateral ischemic stroke within 2 yr']","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0205139', 'cui_str': 'Hemispheric (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0007276', 'cui_str': 'Carotid Artery, Internal'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0265101', 'cui_str': 'Carotid artery obstruction (disorder)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1263853', 'cui_str': 'Paralytic stroke (disorder)'}]","[{'cui': 'C0580586', 'cui_str': 'Extracranial (qualifier value)'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C1536078', 'cui_str': 'Bypass surgery'}]","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]",195.0,0.220234,"For nonsurgical participants, there was no significant difference in the primary endpoint for rHEMI+ vs rHEMI- patients (P = .410).
","[{'ForeName': 'Fadi', 'Initials': 'F', 'LastName': 'Nahab', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'Haseeb A', 'Initials': 'HA', 'LastName': 'Rahman', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'Srikant', 'Initials': 'S', 'LastName': 'Rangaraju', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Barrow', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Cawley', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Grubb', 'Affiliation': 'Charleston, South Carolina.'}, {'ForeName': 'Colin P', 'Initials': 'CP', 'LastName': 'Derdeyn', 'Affiliation': 'University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Harold P', 'Initials': 'HP', 'LastName': 'Adams', 'Affiliation': 'University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Tom O', 'Initials': 'TO', 'LastName': 'Videen', 'Affiliation': 'Santa Fe, New Mexico.'}, {'ForeName': 'M Bridget', 'Initials': 'MB', 'LastName': 'Zimmerman', 'Affiliation': 'University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Powers', 'Affiliation': 'University of North Carolina, Chapel Hill, North Carolina.'}]",Neurosurgery,['10.1093/neuros/nyz352']
1851,31285591,Randomised phase II trial of mFOLFOX6 plus bevacizumab versus mFOLFOX6 plus cetuximab as first-line treatment for colorectal liver metastasis (ATOM trial).,"BACKGROUND


Chemotherapy with biologics followed by liver surgery improves the resection rate and survival of patients with colorectal liver metastasis (CRLM). However, no prospective study has compared the outcomes of chemotherapy with bevacizumab (BEV) versus cetuximab (CET).
METHODS


The ATOM study is the first randomised trial comparing BEV and CET for initially unresectable CRLM. Patients were randomly assigned in a 1:1 ratio to receive mFOLFOX6 plus either BEV or CET. The primary endpoint was progression-free survival (PFS).
RESULTS


Between May 2013 and April 2016, 122 patients were enrolled. Median PFS was 11.5 months (95% CI 9.2-13.3 months) in the BEV group and 14.8 months (95% CI 9.7-17.3 months) in the CET group (hazard ratio 0.803; P = 0.33). Patients with a smaller-number but larger-sized metastases did better in the CET group. In the BEV and CET groups, the response rates were 68.4% and 84.7% and the resection rates were 56.1% and 49.2%, respectively.
CONCLUSION


Although CET achieved a better response rate than BEV for patients with a small number of large liver metastases, both biologics had similar efficacy regarding liver resection and acceptable safety profiles. To achieve optimal PFS, biologics should be selected in accordance with patient conditions.
TRIAL REGISTRATION


This trial is registered at ClinicalTrials.gov (number NCT01836653), and UMIN Clinical Trials Registry (UMIN-CTR number UMIN000010209).",2019,Median PFS was 11.5 months (95% CI 9.2-13.3 months) in the BEV group and 14.8 months (95% CI 9.7-17.3 months) in the CET group (hazard ratio 0.803; P = 0.33).,"['Between May 2013 and April 2016, 122 patients were enrolled', 'patients with colorectal liver metastasis (CRLM']","['mFOLFOX6 plus either BEV or CET', 'CET', 'mFOLFOX6 plus bevacizumab versus mFOLFOX6 plus cetuximab', 'chemotherapy with bevacizumab (BEV) versus cetuximab (CET']","['progression-free survival (PFS', 'resection rates', 'response rates', 'response rate', 'resection rate and survival', 'Median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",122.0,0.166579,Median PFS was 11.5 months (95% CI 9.2-13.3 months) in the BEV group and 14.8 months (95% CI 9.7-17.3 months) in the CET group (hazard ratio 0.803; P = 0.33).,"[{'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Oki', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. okieiji@surg2.med.kyushu-u.ac.jp.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Emi', 'Affiliation': 'Department of Surgery, Saiseikai Fukuoka General Hospital, Fukuoka, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Uetake', 'Affiliation': 'Department of Surgical Oncology and Gastroenterology, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Department of Surgical Oncology, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Nagasaka', 'Affiliation': 'Department of Clinical Oncology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Etsuro', 'Initials': 'E', 'LastName': 'Hatano', 'Affiliation': 'Department of Hepato-Biliary-Pancreatic Surgery, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Ojima', 'Affiliation': 'Department of Surgery, Gunma Prefectural Cancer Center, Ota, Japan.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Manaka', 'Affiliation': 'Department of Surgery, Kyoto Katsura Hospital, Kyoto, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Kusumoto', 'Affiliation': 'Department of Surgery, National Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Katayose', 'Affiliation': 'Department of Hepatobiliary and Pancreatic, Tohoku Medical and Pharmaceutical University, Sendai, Japan.'}, {'ForeName': 'Toshiyoshi', 'Initials': 'T', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Gastroenterological Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': 'Department of Surgical Oncology, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Unno', 'Affiliation': 'Department of Surgery, Tohoku University, Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Ichinosuke', 'Initials': 'I', 'LastName': 'Hyodo', 'Affiliation': 'Division of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Naohiro', 'Initials': 'N', 'LastName': 'Tomita', 'Affiliation': 'Divison of Lower GI Surgery, Department of Surgery, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Sugihara', 'Affiliation': 'Department of Surgical Oncology and Gastroenterology, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Maehara', 'Affiliation': 'Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers, Fukuoka, Japan.'}]",British journal of cancer,['10.1038/s41416-019-0518-2']
1852,31833849,Week 96 results of a phase 3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive HIV-1 patients.,"BACKGROUND


Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg was investigated through 96 weeks in AMBER (NCT02431247).
METHODS


Treatment-naive, HIV-1-positive adults [screening plasma viral load ≥1000 copies/ml; CD4 cell count >50 cells/μl) were randomized (1 : 1) to D/C/F/TAF (N = 362) or D/C plus emtricitabine/tenofovir-disoproxil-fumarate (F/TDF) (N = 363) over at least 48 weeks. After week 48, patients could continue on or switch to D/C/F/TAF in an open-label extension phase until week 96.
RESULTS


At week 96, D/C/F/TAF exposure was 626 patient-years (D/C/F/TAF arm) and 109 patient-years (control arm post switch), week 96 virologic suppression (viral load <50 copies/ml; FDA-Snapshot, from baseline) was 85.1% (308/362) (D/C/F/TAF) and 83.7% (304/363) (control). Week 96 virologic failure (viral load ≥50 copies/ml; FDA-Snapshot) was 5.5% (20/362) and 4.4% (16/363), respectively. No darunavir, primary protease inhibitor or tenofovir resistance-associated mutations (RAMs) were observed post baseline. In one patient in each arm, an M184I and/or V RAM was detected. Few adverse event-related discontinuations (3% D/C/F/TAF; <1% control post switch) and no deaths occurred on D/C/F/TAF. Improved renal and bone parameters were maintained in the D/C/F/TAF arm and observed in the control arm post switch. Increases in total-cholesterol/high-density-lipoprotein--cholesterol rtio at week 96 were +0.25 versus baseline (D/C/F/TAF) and +0.24 versus switch (control).
CONCLUSION


At week 96, D/C/F/TAF resulted in high virologic response and low virologic failure rates, with no resistance development to darunavir or TAF/TDF. Bone, renal and lipid safety were consistent with known D/C/F/TAF component profiles. Control arm safety post switch was consistent with the D/C/F/TAF arm. AMBER week 96 results confirm the efficacy, high barrier to resistance and bone/renal safety benefits of D/C/F/TAF for treatment-naive patients.",2020,"Week 96 virologic failure (viral load ≥50 copies/ml; FDA-Snapshot) was 5.5% (20/362) and 4.4% (16/363), respectively.","['Treatment-naive, HIV-1-positive adults [screening plasma viral load ≥1000\u200acopies/ml; CD4 cell count >50\u200acells/μl) were randomized ', 'treatment-naive HIV-1 patients']","['darunavir/cobicistat/emtricitabine/tenofovir alafenamide', 'D/C/F/TAF (N\u200a=\u200a362) or D/C plus emtricitabine/tenofovir-disoproxil-fumarate (F/TDF', 'Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF']","['efficacy, high barrier to resistance and bone/renal safety benefits', 'Improved renal and bone parameters', 'No darunavir, primary protease inhibitor or tenofovir resistance-associated mutations (RAMs', 'Bone, renal and lipid safety', 'total-cholesterol/high-density-lipoprotein--cholesterol rtio', 'deaths', 'virologic response and low virologic failure rates']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1435444', 'cui_str': 'darunavir'}, {'cui': 'C3177235', 'cui_str': 'cobicistat'}, {'cui': 'C4059167', 'cui_str': 'emtricitabine / tenofovir alafenamide'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2929052', 'cui_str': 'emtricitabine / tenofovir disoproxil'}, {'cui': 'C0220833', 'cui_str': 'fumarate'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1435444', 'cui_str': 'darunavir'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1268897', 'cui_str': 'Product containing protease inhibitor'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1699206', 'cui_str': 'Virologic failure'}]",,0.0799498,"Week 96 virologic failure (viral load ≥50 copies/ml; FDA-Snapshot) was 5.5% (20/362) and 4.4% (16/363), respectively.","[{'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Orkin', 'Affiliation': 'Department of Infection and Immunity, Queen Mary University, London, UK.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Eron', 'Affiliation': 'Department of Medicine, The University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Rockstroh', 'Affiliation': 'Department of Medicine I, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Podzamczer', 'Affiliation': ""Infectious Diseases Department, IDIBELL-Hospital Universitari de Bellvitge, L'Hospitalet, Barcelona, Spain.""}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Esser', 'Affiliation': 'Department of Dermatology and Venerology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Linos', 'Initials': 'L', 'LastName': 'Vandekerckhove', 'Affiliation': 'Department of Internal Medicine and Pediatrics, Ghent University and Ghent University Hospital, Ghent.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Van Landuyt', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Erkki', 'Initials': 'E', 'LastName': 'Lathouwers', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Hufkens', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Jezorwski', 'Affiliation': 'Janssen Research & Development, Pennington, New Jersey, USA.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Opsomer', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","AIDS (London, England)",['10.1097/QAD.0000000000002463']
1853,31810797,"Tivozanib versus sorafenib in patients with advanced renal cell carcinoma (TIVO-3): a phase 3, multicentre, randomised, controlled, open-label study.","BACKGROUND


Treatment for renal cell carcinoma has been revolutionised by inhibitors of VEGF receptor. Previous studies have suggested that treatment with a VEGF receptor (VEGFR) tyrosine kinase inhibitor might be effective in patients who had previous checkpoint inhibitor therapy. Therefore, TIVO-3 was designed to compare the efficacy and safety of tivozanib (a potent and selective VEGFR inhibitor) with those of sorafenib as third-line or fourth-line therapy in patients with metastatic renal cell carcinoma.
METHODS


In this open-label, randomised, controlled trial done at 120 academic hospitals in 12 countries, we enrolled eligible patients older than 18 years with histologically or cytologically confirmed metastatic renal cell carcinoma and at least two previous systemic treatments (including at least one previous treatment with a VEGFR inhibitor), measurable disease according to the Response Evaluation Criteria in Solid Tumors version 1.1, and an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients were excluded if they had received previous treatment with tivozanib or sorafenib. Patients were stratified by International Metastatic Renal Cell Carcinoma Database Consortium risk category and type of previous therapy and randomised (1:1) with a complete permuted block design (block size of four) to either tivozanib 1·5 mg orally once daily in 4-week cycles or sorafenib 400 mg orally twice daily continuously. Investigators and patients were not masked to treatment. The primary endpoint was progression-free survival by independent review in the intention-to-treat population. Safety analyses were done in all patients who received at least one dose of study treatment. This trial is registered with ClinicalTrials.gov, NCT02627963.
FINDINGS


Between May 24, 2016, and Aug 14, 2017, 350 patients were randomly assigned to receive tivozanib (175 patients) or sorafenib (175 patients). Median follow-up was 19·0 months (IQR 15·0-23·4). Median progression-free survival was significantly longer with tivozanib (5·6 months, 95% CI 5·29-7·33) than with sorafenib (3·9 months, 3·71-5·55; hazard ratio 0·73, 95% CI 0·56-0·94; p=0·016). The most common grade 3 or 4 treatment-related adverse event was hypertension (35 [20%] of 173 patients treated with tivozanib and 23 [14%] of 170 patients treated with sorafenib). Serious treatment-related adverse events occurred in 19 (11%) patients with tivozanib and in 17 (10%) patients with sorafenib. No treatment-related deaths were reported.
INTERPRETATION


Our study showed that tivozanib as third-line or fourth-line therapy improved progression-free survival and was better tolerated compared with sorafenib in patients with metastatic renal cell carcinoma.
FUNDING


AVEO Oncology.",2020,"Median progression-free survival was significantly longer with tivozanib (5·6 months, 95% CI 5·29-7·33) than with sorafenib (3·9 months, 3·71-5·55; hazard ratio 0·73, 95% CI 0·56-0·94; p=0·016).","['patients with advanced renal cell carcinoma (TIVO-3', 'patients who had previous checkpoint inhibitor therapy', 'renal cell carcinoma', 'Between May 24, 2016, and Aug 14, 2017, 350 patients', 'patients with metastatic renal cell carcinoma', '120 academic hospitals in 12 countries, we enrolled eligible patients older than 18 years with histologically or cytologically confirmed metastatic renal cell carcinoma and at least two previous systemic treatments (including at least one previous treatment with a VEGFR inhibitor), measurable disease according to the Response Evaluation Criteria in Solid Tumors version 1.1, and an Eastern Cooperative Oncology Group performance status of 0 or 1', 'Patients were stratified by International Metastatic Renal Cell Carcinoma Database Consortium risk category and type of previous therapy and randomised (1:1) with a complete permuted block design (block size of four) to either']","['VEGF receptor (VEGFR) tyrosine kinase inhibitor', 'tivozanib', 'tivozanib 1·5 mg orally once daily in 4-week cycles or sorafenib 400 mg orally twice daily continuously', 'sorafenib', 'Tivozanib versus sorafenib', 'tivozanib or sorafenib']","['adverse events', 'progression-free survival', 'efficacy and safety', 'Median progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}]","[{'cui': 'C0148199', 'cui_str': 'VEGF Receptors'}, {'cui': 'C0033681', 'cui_str': 'Tyrosylprotein Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2827667', 'cui_str': 'tivozanib'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",350.0,0.273877,"Median progression-free survival was significantly longer with tivozanib (5·6 months, 95% CI 5·29-7·33) than with sorafenib (3·9 months, 3·71-5·55; hazard ratio 0·73, 95% CI 0·56-0·94; p=0·016).","[{'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Hematology and Medical Oncology, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH, USA. Electronic address: rinib2@ccf.org.'}, {'ForeName': 'Sumanta K', 'Initials': 'SK', 'LastName': 'Pal', 'Affiliation': 'Kidney Cancer Program, City of Hope National Medical Center, Duarte, CA, USA.'}, {'ForeName': 'Bernard J', 'Initials': 'BJ', 'LastName': 'Escudier', 'Affiliation': 'Department of Oncology Medicine, Gustave Roussy Cancer Campus, Villejuif, France.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Atkins', 'Affiliation': 'Department of Medical Oncology, Georgetown Lombardi University Hospital, Lombardi Comprehensive Cancer Center, Washington, DC, USA.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Hutson', 'Affiliation': 'Urologic Oncology, Baylor Sammons Cancer Center-Texas Oncology, Dallas, TX, USA.'}, {'ForeName': 'Camillo', 'Initials': 'C', 'LastName': 'Porta', 'Affiliation': 'Department of Internal Medicine, University of Pavia Chief, Division of Translational Oncology, IRCCS Istituti Clinici Scientifici Maugeri, Pavia, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Verzoni', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Needle', 'Affiliation': 'AVEO Oncology, Cambridge, MA, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'McDermott', 'Affiliation': 'Department of Hematology/Oncology, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30735-1']
1854,31806543,"Adjuvant denosumab in early breast cancer (D-CARE): an international, multicentre, randomised, controlled, phase 3 trial.","BACKGROUND


Denosumab is a fully human monoclonal antibody that binds to, and inhibits, the receptor activator of RANKL (TNFSF11) and might affect breast cancer biology, as shown by preclinical evidence. We aimed to assess whether denosumab combined with standard-of-care adjuvant or neoadjuvant systemic therapy and locoregional treatments would increase bone metastasis-free survival in women with breast cancer.
METHOD


In this international, double-blind, randomised, placebo-controlled, phase 3 study (D-CARE), patients were recruited from 389 centres in 39 countries. We enrolled women (aged ≥ 18 years) with histologically confirmed stage II or III breast cancer and an Eastern Cooperative Oncology Group performance status of 0 or 1. On eligibility confirmation, investigators at each site telephoned an interactive voice response system to centrally randomly assign patients (1:1) based on a fixed stratified permuted block randomisation list (block size 4) to receive either denosumab (120 mg) or matching placebo subcutaneously every 3-4 weeks, starting with neoadjuvant or adjuvant chemotherapy, for about 6 months and then every 12 weeks for a total duration of 5 years. Stratification factors were breast cancer therapy, lymph node status, hormone receptor and HER2 status, age, and geographical region. The primary endpoint was the composite endpoint of bone metastasis-free survival. This trial is registered with ClinicalTrials.gov, NCT01077154.
FINDINGS


Between June 2, 2010, and Aug 24, 2012, 4509 women were randomly assigned to receive denosumab (n=2256) or placebo (n=2253) and included in the intention-to-treat analysis. The primary analysis of the study was done when all patients had the opportunity to complete 5 years of follow-up with an analysis data cutoff date of Aug 31, 2017. The primary endpoint of bone metastasis-free survival was not significantly different between the groups (median not reached in either group; hazard ratio 0·97, 95% CI 0·82-1·14; p=0·70). The most common grade 3 or worse treatment-emergent adverse events, reported in patients who had at least one dose of the investigational product (2241 patients with denosumab vs 2218 patients with placebo), were neutropenia (340 [15%] vs 328 [15%]), febrile neutropenia (112 [5%] vs 142 [6%]), and leucopenia (62 [3%] vs 61 [3%]). Positively adjudicated osteonecrosis of the jaw occurred in 122 (5%) of 2241 patients treated with denosumab versus four (<1%) of 2218 patients treated with placebo; treatment-emergent hypocalcaemia occurred in 152 (7%) versus 82 (4%). Two treatment-related deaths occurred in the placebo group due to acute myeloid leukaemia and depressed level of consciousness.
INTERPRETATION


Despite preclinical evidence suggesting RANKL inhibition might delay bone metastasis or disease recurrence in patients with early-stage breast cancer, in this study, denosumab did not improve disease-related outcomes for women with high-risk early breast cancer.
FUNDING


Amgen.",2020,"The primary endpoint of bone metastasis-free survival was not significantly different between the groups (median not reached in either group; hazard ratio 0·97, 95% CI 0·82-1·14; p=0·70).","['enrolled women (aged ≥ 18 years) with histologically confirmed stage II or III breast cancer and an Eastern Cooperative Oncology Group performance status of 0 or 1', 'women with breast cancer', 'patients with early-stage breast cancer', 'all patients had the opportunity to complete 5 years of follow-up with an analysis data cutoff date of Aug 31, 2017', 'early breast cancer (D-CARE', 'Between June 2, 2010, and Aug 24, 2012, 4509 women', 'patients were recruited from 389 centres in 39 countries', 'women with high-risk early breast cancer']","['Adjuvant denosumab', 'placebo', 'denosumab (120 mg) or matching placebo subcutaneously every 3-4 weeks, starting with neoadjuvant or adjuvant chemotherapy', 'denosumab combined with standard-of-care adjuvant or neoadjuvant systemic therapy and locoregional treatments', 'denosumab']","['febrile neutropenia', 'bone metastasis-free survival', 'deaths', 'acute myeloid leukaemia and depressed level of consciousness', 'neutropenia', 'composite endpoint of bone metastasis-free survival', 'emergent hypocalcaemia', 'leucopenia']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C4517752', 'cui_str': '389 (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0549249', 'cui_str': 'Depressed Level of Consciousness'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}]",2218.0,0.71545,"The primary endpoint of bone metastasis-free survival was not significantly different between the groups (median not reached in either group; hazard ratio 0·97, 95% CI 0·82-1·14; p=0·70).","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Coleman', 'Affiliation': 'Department of Oncology and Metabolism, University of Sheffield, Sheffield, UK. Electronic address: r.e.coleman@sheffield.ac.uk.'}, {'ForeName': 'Dianne M', 'Initials': 'DM', 'LastName': 'Finkelstein', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Barrios', 'Affiliation': 'Centro de Pesquisa em Oncologia, Hospital São Lucas, Pontifical Catholic University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Instituto de Investigacion Sanitaria Gregorio Marañon, Ciberonc, Geicam, Universidad Complutense, Madrid, Spain.'}, {'ForeName': 'Hiroji', 'Initials': 'H', 'LastName': 'Iwata', 'Affiliation': 'Aichi Cancer Center Hospital, Nayoya, Japan.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Hegg', 'Affiliation': 'Hospital Pérola Byington and Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Glaspy', 'Affiliation': 'UCLA School of Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'Alvaro Montaño', 'Initials': 'AM', 'LastName': 'Periañez', 'Affiliation': 'Hospital Universitario Virgen del Rocio, Sevilla, Spain.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Tonkin', 'Affiliation': 'Cross Cancer Institute, Edmonton, AB, Canada.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Deleu', 'Affiliation': 'Oncology Center, AZ Nikolass, Sint-Niklaas, Belgium.'}, {'ForeName': 'Joohyuk', 'Initials': 'J', 'LastName': 'Sohn', 'Affiliation': 'Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Crown', 'Affiliation': 'All-Ireland Co-Operative Oncology Research Group, Dublin, Ireland.'}, {'ForeName': 'Suzette', 'Initials': 'S', 'LastName': 'Delaloge', 'Affiliation': 'Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Dai', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Jandial', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Chan', 'Affiliation': 'Breast Cancer Research Centre Western Australia and School of Medicine, Curtin University, Perth, WA, Australia.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30687-4']
1855,31785594,Neonatal encephalopathy therapy optimization for better neuroprotection with inhalation of CO 2 : the HENRIC feasibility and safety trial.,"BACKGROUND


There is an association between hypocapnia and adverse neurodevelopmental outcome in infants with neonatal encephalopathy (NE). Our aim was to test the safety and feasibility of 5% CO 2  and 95% air inhalation to correct hypocapnia in mechanically ventilated infants with NE undergoing therapeutic hypothermia.
METHODS


Ten infants were assigned to this open-label, single-center trial. The gas mixture of 5% CO 2  and 95% air was administered through patient circuits if the temperature-corrected PCO 2  ≤40 mm Hg. The CO 2  inhalation was continued for 12 h or was stopped earlier if the base deficit (BD) level decreased <5 mmol/L. Follow-up was performed using Bayley Scales of Infant Development II.
RESULTS


The patients spent a median 95.1% (range 44.6-98.5%) of time in the desired PCO 2  range (40-60 mm Hg) during the inhalation. All PCO 2  values were >40 mm Hg, the lower value of the target range. Regression modeling revealed that BD and lactate had a tendency to decrease during the intervention (by 0.61 and 0.55 mmol/L/h, respectively), whereas pH remained stable. The rate of moderate disabilities and normal outcome was 50%.
CONCLUSIONS


Our results suggest that inhaled 5% CO 2  administration is a feasible and safe intervention for correcting hypocapnia.",2020,"Regression modeling revealed that BD and lactate had a tendency to decrease during the intervention (by 0.61 and 0.55 mmol/L/h, respectively), whereas pH remained stable.","['mechanically ventilated infants with NE undergoing therapeutic hypothermia', 'infants with neonatal encephalopathy (NE']",[],"['rate of moderate disabilities and normal outcome', 'safety and feasibility']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0020674', 'cui_str': 'Targeted Temperature Management'}, {'cui': 'C0235820', 'cui_str': 'Neonatal encephalopathy (disorder)'}]",[],"[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.143105,"Regression modeling revealed that BD and lactate had a tendency to decrease during the intervention (by 0.61 and 0.55 mmol/L/h, respectively), whereas pH remained stable.","[{'ForeName': 'Eniko', 'Initials': 'E', 'LastName': 'Szakmar', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Kata', 'Initials': 'K', 'LastName': 'Kovacs', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Unoke', 'Initials': 'U', 'LastName': 'Meder', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Geza', 'Initials': 'G', 'LastName': 'Bokodi', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Csilla', 'Initials': 'C', 'LastName': 'Andorka', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Lakatos', 'Affiliation': 'MR Research Centre, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Attila J', 'Initials': 'AJ', 'LastName': 'Szabo', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Gusztav', 'Initials': 'G', 'LastName': 'Belteki', 'Affiliation': 'Neonatal Intensive Care Unit, Cambridge University Hospitals NHS Trust, Cambridge, UK.'}, {'ForeName': 'Miklos', 'Initials': 'M', 'LastName': 'Szabo', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Jermendy', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary. jermendy.agnes@med.semmelweis-univ.hu.'}]",Pediatric research,['10.1038/s41390-019-0697-9']
1856,31512050,"Effectiveness of a brief psychotherapeutic intervention compared with treatment as usual for adolescent nonsuicidal self-injury: a single-centre, randomised controlled trial.","Although nonsuicidal self-injury (NSSI) is a clinically significant behavior, evidence-based, specific, time-, and cost-effective treatment approaches are lacking. The aim of this study was to compare the efficacies of a brief cognitive-behavioral psychotherapy manual, the Cutting Down Programme (CDP), and treatment as usual (TAU) in the treatment of adolescent NSSI. We conducted a single-centre randomised controlled trial (RCT). Eligible participants were aged 12-17 years engaging in repetitive NSSI (at least 5 times within the past 6 months). We randomly allocated 74 participants to CDP (n = 37) or TAU (n = 37; in a 1:1 ratio). Outcome measures were administered before treatment (T0), directly after CDP or 4 months after baseline evaluation in the TAU group (T1), and another 6 months later (T2; primary endpoint). Primary outcome was a 50% reduction in NSSI frequency within the past 6 months at 10-month follow-up (T2). Regarding the primary outcome, there were no significant differences between the CDP (n = 26; 70.3%) and TAU group [n = 27; 73.0%; χ 2 (1) = 0.07; p = 0.797]; NSSI frequency within the past 6 months was significantly reduced at T2 [χ 2 (1) = 12.45; p < 0.001] with no between-group difference [χ 2 (1) = 0.14; p = 0.704]. However, we found a significant group x point of measurement interaction [χ 2 (2) = 7.78; p = 0.021] regarding NSSI within the last month indicating at T1. CDP was equally effective and achieved faster recovery compared to a significantly more intensive TAU in treating adolescent NSSI. The CDP could provide a brief and pragmatic first treatment within a stepped-care model for NSSI in routine clinical care.Clinical Trial Registration The trial was prospectively registered in the German Registry of Clinical Trials (https://www.drks.de; DRKS00003605) and is now complete.",2020,Primary outcome was a 50% reduction in NSSI frequency within the past 6 months at 10-month follow-up (T2).,"['adolescent NSSI', 'Eligible participants were aged 12-17\xa0years engaging in repetitive NSSI', 'adolescent nonsuicidal self-injury']","['CDP', 'TAU', 'cognitive-behavioral psychotherapy manual, the Cutting Down Programme (CDP', 'psychotherapeutic intervention']",['NSSI frequency'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0085271', 'cui_str': 'Self-Injury'}]","[{'cui': 'C0010724', 'cui_str': 'CDP'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",74.0,0.188995,Primary outcome was a 50% reduction in NSSI frequency within the past 6 months at 10-month follow-up (T2).,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kaess', 'Affiliation': 'University Hospital of Child and Adolescent Psychiatry and Psychotherapy, University of Bern, Stöckli, Bolligenstrasse 141c, 3000, Bern 60, Switzerland. michael.kaess@upd.ch.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Edinger', 'Affiliation': 'Section for Translational Psychobiology in Child and Adolescent Psychiatry, Clinic of Child and Adolescent Psychiatry, Centre for Psychosocial Medicine, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Fischer-Waldschmidt', 'Affiliation': 'Clinic of Child and Adolescent Psychiatry, Centre for Psychosocial Medicine, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Parzer', 'Affiliation': 'Clinic of Child and Adolescent Psychiatry, Centre for Psychosocial Medicine, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Romuald', 'Initials': 'R', 'LastName': 'Brunner', 'Affiliation': 'Clinic and Policlinic of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Regensburg, Regensburg District Hospital, Regensburg, Germany.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Resch', 'Affiliation': 'Clinic of Child and Adolescent Psychiatry, Centre for Psychosocial Medicine, University Hospital Heidelberg, Heidelberg, Germany.'}]",European child & adolescent psychiatry,['10.1007/s00787-019-01399-1']
1857,31925414,Patient Engagement With an Automated Telephone Symptom Management Intervention: Predictors and Outcomes.,"BACKGROUND


Self-management of symptoms related to cancer and its treatment is important for maintaining treatment regimens and improving outcomes.
PURPOSE


To determine factors associated with engagement in a symptom self-management intervention among patients initiating oral anticancer treatment.
METHODS


This secondary analysis included 127 patients randomized to the medication adherence reminder and symptom management intervention in a recently completed trial. Patients were recruited from six Comprehensive Cancer Centers, interviewed at intake, and mailed a Symptom Management Toolkit (Toolkit) with self-care management strategies for 18 symptoms. During eight automated telephone weekly calls, patients were asked to use the Toolkit to manage elevated symptoms. Toolkit use and symptoms were tracked weekly, and generalized linear mixed-effects models were used to determine factors predictive of Toolkit use. General linear modeling was used to relate the Toolkit use during intervention to postintervention symptom severity.
RESULTS


Better cognitive function at intake into the trial and higher symptom burden were predictive of the patients' initial decision to try the Toolkit during Week 1. In subsequent weeks, Toolkit use in the previous week and worsening of symptoms were associated with greater odds of Toolkit use. The extent of Toolkit use modified the relationship between intake and 8 week symptom severity: among patients with higher levels of severity at intake, use of the Toolkit conferred greater benefit at 8 weeks.
CONCLUSIONS


Patients make realistic decisions regarding when to use a self-directed approach to self-management and are likely to use strategies when their symptoms are higher and to forego use once symptoms subside.
CLINICAL TRIAL REGISTRATION


NCT02043184.",2020,"The extent of Toolkit use modified the relationship between intake and 8 week symptom severity: among patients with higher levels of severity at intake, use of the Toolkit conferred greater benefit at 8 weeks.
","['patients with higher levels of severity at intake', '127 patients randomized to the', 'patients initiating oral anticancer treatment', 'Patients were recruited from six Comprehensive Cancer Centers, interviewed at intake, and mailed a Symptom Management Toolkit (Toolkit) with self-care management strategies for 18 symptoms']","['Automated Telephone Symptom Management Intervention', 'medication adherence reminder and symptom management intervention']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C1536570', 'cui_str': 'Symptom management (procedure)'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1536570', 'cui_str': 'Symptom management (procedure)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}]",[],127.0,0.0266875,"The extent of Toolkit use modified the relationship between intake and 8 week symptom severity: among patients with higher levels of severity at intake, use of the Toolkit conferred greater benefit at 8 weeks.
","[{'ForeName': 'Alla', 'Initials': 'A', 'LastName': 'Sikorskii', 'Affiliation': 'Department of Psychiatry and Department of Statistics and Probability, Michigan, State University, East Lansing, MI, USA.'}, {'ForeName': 'Charles W', 'Initials': 'CW', 'LastName': 'Given', 'Affiliation': 'College of Nursing, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Given', 'Affiliation': 'College of Nursing, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Asish', 'Initials': 'A', 'LastName': 'Banik', 'Affiliation': 'Department of Statistics and Probability, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Krauss', 'Affiliation': 'Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaz067']
1858,30643982,"Efficacy and safety of a crystalline lactulose preparation (SK-1202) in Japanese patients with chronic constipation: a randomized, double-blind, placebo-controlled, dose-finding study.","BACKGROUND


Clinical evidence of lactulose for chronic constipation in Japan was lacking. We performed a randomized, double-blind, placebo-controlled, dose-finding study in Japanese patients with chronic constipation to estimate the optimal clinical dose of lactulose.
METHODS


Overall, 250 patients were randomized to receive SK-1202 (13, 26, or 39 g/day, as crystalline lactulose dosage) or placebo twice daily (morning and evening) orally for 2 weeks. The primary endpoint was the change from baseline frequency of spontaneous bowel movements (SBMs) at Week 1. The secondary endpoints included the change from baseline of SBMs at Week 2, percentage of patients experiencing SBM within 24 and/or 48 h of the initial dose, stool consistency, and constipation severity, and adverse events were also evaluated.
RESULTS


The 26 and 39 g/day of SK-1202 induced significantly and dose-dependently more increase in SBM at Week 1 than placebo (p = 0.003, p < 0.001). These groups also showed significant improvements in the secondary endpoints. There were no significant differences in the incidence of adverse drug reactions (ADRs) between the placebo and SK-1202 groups. Gastrointestinal disorder was the most common ADR, and diarrhea developed in 6 patients (9.7%) treated with 39 g/day; however, the symptoms were mild in severity and resolved after follow-up, dose reduction, or dose suspension. SK-1202 was generally well tolerated up to 39 g/day.
CONCLUSION


Our results suggest that SK-1202 is useful in Japanese patients with chronic constipation, and optimal dose of SK-1202 is 26 g/day.",2019,There were no significant differences in the incidence of adverse drug reactions (ADRs) between the placebo and SK-1202 groups.,"['250 patients', 'Japanese patients with chronic constipation']","['SK-1202', 'lactulose', 'placebo', 'crystalline lactulose preparation (SK-1202']","['change from baseline of SBMs at Week 2, percentage of patients experiencing SBM within 24 and/or 48\xa0h of the initial dose, stool consistency, and constipation severity, and adverse events', 'SBM', 'Gastrointestinal disorder', 'Efficacy and safety', 'diarrhea', 'incidence of adverse drug reactions (ADRs', 'change from baseline frequency of spontaneous bowel movements (SBMs']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0401149', 'cui_str': 'Chronic constipation (disorder)'}]","[{'cui': 'C0022957', 'cui_str': 'Lactulose'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0017178', 'cui_str': 'Gastrointestinal Diseases'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}]",250.0,0.563787,There were no significant differences in the incidence of adverse drug reactions (ADRs) between the placebo and SK-1202 groups.,"[{'ForeName': 'Kunio', 'Initials': 'K', 'LastName': 'Kasugai', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Aichi Medical University School of Medicine, 1-1 Yazakokarimata, Nagakute, Aichi, 480-1195, Japan. kuku3487@aichi-med-u.ac.jp.'}, {'ForeName': 'Hisakazu', 'Initials': 'H', 'LastName': 'Iwai', 'Affiliation': 'Sanwa Kagaku Kenkyusho Co., Ltd., Nagoya, Japan.'}, {'ForeName': 'Noboru', 'Initials': 'N', 'LastName': 'Kuboyama', 'Affiliation': 'Sanwa Kagaku Kenkyusho Co., Ltd., Nagoya, Japan.'}, {'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Yoshikawa', 'Affiliation': 'Sanwa Kagaku Kenkyusho Co., Ltd., Nagoya, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Fukudo', 'Affiliation': 'Department of Behavioral Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.'}]",Journal of gastroenterology,['10.1007/s00535-018-01545-7']
1859,32043630,Changes in skin barrier function following single and repeated applications of 4 types of moisturizers: a randomized controlled trial.,,2020,"Here, we compared the effect of 4 types of moisturizers containing humectant (A), occlusive (B), ceramide (C) and hydrating (D) ingredients on healthy skin barrier function, after single application as well as after two weeks of repeated use (table 1).",['4 types of moisturizers'],"['moisturizers containing humectant (A), occlusive (B), ceramide (C) and hydrating (D) ingredients']","['skin barrier function', 'healthy skin barrier function']","[{'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C2936383', 'cui_str': 'Humectants'}, {'cui': 'C0007745', 'cui_str': 'Ceramides'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.116952,"Here, we compared the effect of 4 types of moisturizers containing humectant (A), occlusive (B), ceramide (C) and hydrating (D) ingredients on healthy skin barrier function, after single application as well as after two weeks of repeated use (table 1).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Samadi', 'Affiliation': 'Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ahmad Nasrollahi', 'Affiliation': 'Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Maghsoudi Ashtiani', 'Affiliation': 'Pharmaceutical sciences branch, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Abels', 'Affiliation': 'Dr. August Wolff GmbH & Co. KG Arzneimittel, Bielefeld, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Firooz', 'Affiliation': 'Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences, Tehran, Iran.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16288']
1860,31498753,"Positron Emission Tomography-Guided Treatment in Early-Stage Favorable Hodgkin Lymphoma: Final Results of the International, Randomized Phase III HD16 Trial by the German Hodgkin Study Group.","PURPOSE


Combined-modality treatment (CMT) with 2× ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) and small-field radiotherapy is standard of care for patients with early-stage favorable Hodgkin lymphoma (HL). However, the role of radiotherapy has been challenged. Positron emission tomography (PET) after 2× ABVD (PET-2) might help to predict individual outcomes and guide treatment.
METHODS


Between November 2009 and December 2015, we recruited patients age 18 to 75 years with newly diagnosed, early-stage favorable HL for this international randomized phase III trial. Patients were assigned to standard CMT of 2× ABVD and 20-Gy involved-field radiotherapy or PET-guided treatment, omitting involved-field radiotherapy after negative PET-2 (Deauville score < 3). Primary objectives were to exclude inferiority of 10% or more in 5-year progression-free survival (PFS) of ABVD alone compared with CMT in a per-protocol analysis among PET-2-negative patients (noninferiority margin for hazard ratio, 3.01) and to confirm PET-2 positivity (Deauville score ≥ 3) as a risk factor for PFS among CMT-treated patients.
RESULTS


We enrolled 1,150 patients. Median follow-up was 45 months. Among 628 PET-2-negative, per-protocol-treated patients, 5-year PFS was 93.4% (95% CI, 90.4% to 96.5%) with CMT and 86.1% (95% CI, 81.4% to 90.9%) with ABVD (difference 7.3% [95% CI, 1.6% to 13.0%]; hazard ratio, 1.78 [95% CI, 1.02 to 3.12]). Five-year overall survival was 98.1% (95% CI, 96.5% to 99.8%) with CMT and 98.4% (95% CI, 96.5% to 100.0%) with ABVD. Among 693 patients who were assigned to CMT, 5-year PFS was 93.2% (95% CI, 90.2% to 96.2%) among PET-2-negative patients and 88.4% (95% CI, 84.2% to 92.6%) in PET-2-positive patients ( P  = .047). When using the more common liver cutoff (Deauville score, 4) for PET-2 positivity, the difference was more pronounced (5-year PFS, 93.1% [95% CI, 90.7% to 95.5%]  v  80.9% [95% CI, 72.2% to 89.7%];  P  = .0011).
CONCLUSION


In early-stage favorable HL, a positive PET after two cycles ABVD indicates a high risk for treatment failure, particularly when a Deauville score of 4 is used as a cutoff for positivity. In PET-2-negative patients, radiotherapy cannot be omitted from CMT without clinically relevant loss of tumor control.",2019,"Five-year overall survival was 98.1% (95% CI, 96.5% to 99.8%) with CMT and 98.4% (95% CI, 96.5% to 100.0%) with ABVD.","['We enrolled 1,150 patients', 'Between November 2009 and December 2015', '693 patients', 'patients with early-stage favorable Hodgkin lymphoma (HL', 'Early-Stage Favorable Hodgkin Lymphoma', 'recruited patients age 18 to 75 years with newly diagnosed, early-stage favorable HL for this international randomized phase III trial']","['Positron Emission Tomography-Guided Treatment', 'Combined-modality treatment (CMT) with 2× ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) and small-field radiotherapy', 'standard CMT of 2× ABVD and 20-Gy involved-field radiotherapy or PET-guided treatment, omitting involved-field radiotherapy', 'Positron emission tomography (PET', 'radiotherapy']","['5-year PFS', '5-year progression-free survival (PFS) of ABVD', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C1266193', 'cui_str': 'Hodgkin lymphoma - category (morphologic abnormality)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C0042670', 'cui_str': 'Vinblastine'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",1150.0,0.269604,"Five-year overall survival was 98.1% (95% CI, 96.5% to 99.8%) with CMT and 98.4% (95% CI, 96.5% to 100.0%) with ABVD.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fuchs', 'Affiliation': 'German Hodgkin Study Group (GHSG), Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Goergen', 'Affiliation': 'German Hodgkin Study Group (GHSG), Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Kobe', 'Affiliation': 'Department of Nuclear Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Kuhnert', 'Affiliation': 'Department of Nuclear Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Lohri', 'Affiliation': 'Cantonal Hospital Baselland, Liestal, Switzerland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'IIIrd Medical Department, Paracelcus Medical University and Salzburg Cancer Research Institute, Salzburg, Austria.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Sasse', 'Affiliation': 'German Hodgkin Study Group (GHSG), Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Max S', 'Initials': 'MS', 'LastName': 'Topp', 'Affiliation': 'Medizinische Klinik und Poliklinik II, Universitätsklinikum Würzburg, Würzburg, Germany.'}, {'ForeName': 'Erhardt', 'Initials': 'E', 'LastName': 'Schäfer', 'Affiliation': 'Dres. med. Just/Düwel/Riesenberg/Steinke/Schäfer, Studiengesellschaft, Bielefeld, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Hertenstein', 'Affiliation': 'Department of Internal Medicine I, Klinikum Bremen Mitte, Bremen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Soekler', 'Affiliation': 'University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Vogelhuber', 'Affiliation': 'Medizinische Klinik III, Universitätsklinik Regensburg, Regensburg, Germany.'}, {'ForeName': 'Josée M', 'Initials': 'JM', 'LastName': 'Zijlstra', 'Affiliation': 'Amsterdam University Medical Center, Vrije Universiteit, Department of Hematology, Amsterdam, Netherlands.'}, {'ForeName': 'Ulrich Bernd', 'Initials': 'UB', 'LastName': 'Keller', 'Affiliation': 'Department of Internal Medicine III, Klinikum ""Rechts der Isar"", Munich, Germany.'}, {'ForeName': 'Stefan W', 'Initials': 'SW', 'LastName': 'Krause', 'Affiliation': 'Department of Internal Medicine 5, Haematology/Oncology, University of Erlangen, Erlangen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Wilhelm', 'Affiliation': 'Department of Medical Oncology, Klinikum Nürnberg, Paracelsus Medical University, Nürnberg, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Maschmeyer', 'Affiliation': 'Department of Hematology, Oncology and Palliative Care, Klinikum Ernst von Bergmann, Potsdam, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Thiemer', 'Affiliation': 'Clinic for Hematology, Oncology and Immunology, Philipps University, Marburg, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Dührsen', 'Affiliation': 'Department of Haematology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Meissner', 'Affiliation': 'University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Viardot', 'Affiliation': 'Department of Internal Medicine III, University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Eich', 'Affiliation': 'Department of Radiotherapy, University Hospital of Muenster, Muenster, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Baues', 'Affiliation': 'Department of Radiotherapy, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Diehl', 'Affiliation': 'German Hodgkin Study Group (GHSG), Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Rosenwald', 'Affiliation': 'Institute of Pathology, Julius Maximilian University of Würzburg and Comprehensive Cancer Center Mainfranken, Würzburg, Germany.'}, {'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'von Tresckow', 'Affiliation': 'German Hodgkin Study Group (GHSG), Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Dietlein', 'Affiliation': 'Department of Nuclear Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Borchmann', 'Affiliation': 'German Hodgkin Study Group (GHSG), Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Engert', 'Affiliation': 'German Hodgkin Study Group (GHSG), Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00964']
1861,31504417,Residual inflammatory risk associated with interleukin-18 and interleukin-6 after successful interleukin-1β inhibition with canakinumab: further rationale for the development of targeted anti-cytokine therapies for the treatment of atherothrombosis.,"AIMS


The Canakinumab Antiinflammatory Thrombosis Outcomes Study (CANTOS) established that targeting inflammation with interleukin-1β (IL-1β) inhibition can significantly reduce cardiovascular (CV) event rates in the absence of any beneficial effects on cholesterol. Yet, CANTOS participants treated with both high-intensity statins and canakinumab remain at considerable risk for recurrent CV events. Both interleukin-18 (IL-18, which like IL-1β requires the NLRP3 inflammasome for activation) and interleukin-6 (IL-6, a pro-inflammatory cytokine downstream of IL-1) may contribute to the recurrent events that occur even on canakinumab therapy, and thus represent novel targets for treating atherothrombosis.
METHODS AND RESULTS


Plasma samples from 4848 stable post-myocardial infarction patients who were assigned to active IL-1β inhibition or placebo within CANTOS underwent measurement of IL-18 and IL-6 both before and after initiation of canakinumab using validated ELISA. All participants were followed over a median 3.7-year period (maximum 5 years) for recurrent major adverse cardiovascular events (MACE) and for all-cause mortality. Compared to placebo, canakinumab significantly reduced IL-6 levels in a dose-dependent manner yielding placebo-subtracted median percent reductions in IL-6 at 3 months of 24.8%, 36.3%, and 43.2% for the 50, 150, and 300 mg doses, respectively (all P-values <0.001). By contrast, no dose of canakinumab significantly altered IL-18 levels measured at 3 months (all effects <1%, all P-values > 0.05). Yet, despite these differential plasma effects, either baseline and on-treatment levels of IL-18 or IL-6 associated with rates of future CV events. For example, for MACE, each tertile increase in IL-18 measured 3 months after canakinumab initiation associated with a 15% increase in risk [95% confidence interval (CI) 3-29%, P = 0.016], while each tertile increase in IL-6 measured 3 months after canakinumab initiation associated with a 42% increase in risk (95% CI 26-59%, P < 0.0001). Similar effects were observed for MACE-plus, CV death, all-cause mortality, and the for the combination endpoint of all vascular events inclusive of revascularization procedures and hospitalization for congestive heart failure. In baseline as well as on-treatment analyses, risks were highest among those with the highest levels of both IL-18 and IL-6.
CONCLUSION


There remains substantial residual inflammatory risk related to both IL-18 and IL-6 after IL-1β inhibition with canakinumab These data support further pharmacologic development of therapies for atherothrombosis that target IL-18 or IL-6 signalling, or that can simultaneously inhibit both IL-1β and IL-18 (such as NLRP3 inflammasome inhibitors).
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov NCT01327846.",2020,"Compared to placebo, canakinumab significantly reduced IL-6 levels in a dose-dependent manner yielding placebo-subtracted median percent reductions in IL-6 at 3 months of 24.8%, 36.3%, and 43.2% for the 50, 150, and 300 mg doses, respectively (all P-values <0.001).",['Plasma samples from 4848 stable post-myocardial infarction patients who were assigned to active IL-1β inhibition or'],"['placebo', 'canakinumab']","['IL-18 levels', 'IL-6', 'recurrent major adverse cardiovascular events (MACE', 'MACE-plus, CV death, all-cause mortality', 'IL-6 levels', 'IL-18', 'cardiovascular (CV) event rates']","[{'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2718773', 'cui_str': 'canakinumab'}]","[{'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.35441,"Compared to placebo, canakinumab significantly reduced IL-6 levels in a dose-dependent manner yielding placebo-subtracted median percent reductions in IL-6 at 3 months of 24.8%, 36.3%, and 43.2% for the 50, 150, and 300 mg doses, respectively (all P-values <0.001).","[{'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""Department of Medicine, Center for Cardiovascular Disease Prevention, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA.""}, {'ForeName': 'Jean G', 'Initials': 'JG', 'LastName': 'MacFadyen', 'Affiliation': ""Department of Medicine, Center for Cardiovascular Disease Prevention, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA.""}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Thuren', 'Affiliation': 'Novartis Pharmaceutical Corporation, One Health Plaza, East Hanover, NJ 07936, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Libby', 'Affiliation': ""Department of Medicine, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, 75 Francis Street, Boston, MA 02115, USA.""}]",European heart journal,['10.1093/eurheartj/ehz542']
1862,31509210,Effect of MyTeen SMS-Based Mobile Intervention for Parents of Adolescents: A Randomized Clinical Trial.,"Importance


There is global pressure to respond to the burden posed by adolescent mental health problems. The National Mental Health Commission has made a call for investment in mobile health services directed at prevention and early intervention to relieve the demand on targeted mental health services that are costly to provide. Parents and primary caregivers play a significant role in the lives of adolescents and are important targets for such efforts. Currently, there is no evidence for the effectiveness of programs delivered solely via text message for parents of adolescents.
Objective


To evaluate the effects of a text-messaging program (MyTeen) on promoting parental competence and mental health literacy for parents of adolescents.
Design, Setting, and Participants


A parallel 2-group randomized clinical trial was conducted in New Zealand. A total of 221 parents and primary caregivers of adolescents aged 10 to 15 years were recruited from March 19 to August 17, 2018, via community outreach and social media and were randomly allocated 1:1 into the control or the intervention group. Statistical analysis was performed on the principle of intention to treat with adjustment for baseline factors and ethnicity.
Intervention


A text-messaging program for parents of adolescents (age 10-15 years) to promote parental competence and mental health literacy. Participants received 1 daily text message over 4 weeks.
Main Outcomes and Measures


Parental competence, assessed at 1 month after randomization by the Parenting Sense of Competence Scale.
Results


In total, 221 participants (214 [96.8%] female) were randomized, 109 to the intervention group and 112 to the control group; 201 participants (91%) completed the trial at 3 months. Significant group difference was observed on the primary outcome at the end of 1 month of intervention, with participants reporting a higher level of parental competence than those in the control group (estimated mean difference, 3.33 points; 95% CI, 1.37-5.29 points; P = .002). Except for knowledge about mental health, all secondary outcomes were significant, including continued improvement in parental competence at 3 months (estimated mean difference, 4.08 points; 95% CI, 1.96-6.20 points; P < .001), knowledge of help seeking (estimated mean difference, 0.99 points; 95% CI, 0.49-1.50 points; P < .001), parental distress (estimated mean difference, -2.39 points; 95% CI, -4.37 to -0.40 points; P = .02), and parent-adolescent communication (estimated mean difference, 2.21 points; 95% CI, 0.48-3.95 points; P = .01), with participants in the intervention group reporting better parenting-related outcomes than the control group at 1 and 3 months after the intervention.
Conclusions and Relevance


This text-messaging program for parents of adolescents appears to be an effective and feasible way to facilitate the implementation and delivery of evidence-based information to populations that are not easily reached with other intervention modalities. The program can be easily scaled up for delivery as an early preventive intervention and may represent a less expensive option for service delivery.
Trial Registration


anzctr.org.au Identifier: ACTRN12618000117213.",2019,A text-messaging program for parents of adolescents (age 10-15 years) to promote parental competence and mental health literacy.,"['parents of adolescents', 'parents of adolescents (age 10-15 years) to promote parental competence and mental health literacy', '221 participants (214 [96.8%] female) were randomized, 109 to the intervention group and 112 to the control group; 201 participants (91%) completed the trial at 3 months', 'Parents of Adolescents', '221 parents and primary caregivers of adolescents aged 10 to 15 years were recruited from March 19 to August 17, 2018, via community outreach and social media']","['MyTeen SMS-Based Mobile Intervention', 'text-messaging program (MyTeen']","['level of parental competence', 'knowledge of help seeking', 'Parenting Sense of Competence Scale', 'parental distress', 'parental competence and mental health literacy', 'parent-adolescent communication', 'parental competence']","[{'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0282110', 'cui_str': 'Community Outreach'}, {'cui': 'C3179065', 'cui_str': 'Social Media'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0222045'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",221.0,0.227912,A text-messaging program for parents of adolescents (age 10-15 years) to promote parental competence and mental health literacy.,"[{'ForeName': 'Joanna Ting Wai', 'Initials': 'JTW', 'LastName': 'Chu', 'Affiliation': 'The National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Wadham', 'Affiliation': 'The National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Yannan', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'The National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Whittaker', 'Affiliation': 'The National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Stasiak', 'Affiliation': 'Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Shepherd', 'Affiliation': 'School of Psychology, Massey University, Auckland, New Zealand.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bullen', 'Affiliation': 'The National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.11120']
1863,31504721,"Controlled Feeding of an 8-d, High-Dairy Cheese Diet Prevents Sodium-Induced Endothelial Dysfunction in the Cutaneous Microcirculation of Healthy, Older Adults through Reductions in Superoxide.","BACKGROUND


While excess dietary sodium impairs vascular function by increasing oxidative stress, the dietary incorporation of dairy foods improves vascular health. We demonstrated that single-meal cheese consumption ameliorates acute, sodium-induced endothelial dysfunction. However, controlled feeding studies examining the inclusion of cheese, a dairy product that contains both bioactive constituents and sodium, are lacking.
OBJECTIVES


We tested the hypothesis that microcirculatory endothelium-dependent dilation (EDD) would be impaired by a high-sodium diet, but a sodium-matched diet high in dairy cheese would preserve EDD through oxidant stress mechanisms.
METHODS


We gave 11 adults without salt-sensitive blood pressure (<10 mmHg Δ mean arterial pressure; 64 ± 2 y) 4 separate 8-d controlled dietary interventions in a randomized, crossover design: a low-sodium, no-dairy intervention (LNa; 1500 mg/d sodium); a low-sodium, high-cheese intervention (LNaC; 1500 mg/d sodium, 170 g/d cheese); a high-sodium, no-dairy intervention (HNa; 5500 mg/d sodium); and a high-sodium, high-cheese intervention (HNaC; 5500 mg/d sodium, 170 g/d cheese). On Day 8 of each diet, EDD was assessed through a localized infusion (intradermal microdialysis) of acetylcholine (ACh), both alone and during coinfusion of NG-nitro-L-arginine methyl ester (NO synthase inhibitor), L-ascorbate (nonspecific antioxidant), apocynin [NAD(P)H oxidase inhibitor], or tempol (superoxide scavenger).
RESULTS


Compared with LNa, microvascular responsiveness to ACh was attenuated during HNa (LNa: -4.82 ± 0.20 versus HNa: -3.21 ± 0.55 M logEC50; P = 0.03) but not LNaC (-5.44 ± 0.20 M logEC50) or HNaC (-4.46 ± 0.50 M logEC50). Further, ascorbate, apocynin, and tempol administration each increased ACh-induced vasodilation during HNa only (Ringer's: 38.9 ± 2.4; ascorbate: 48.0 ± 2.5; tempol: 45.3 ± 2.7; apocynin: 48.5 ± 2.6% maximum cutaneous vascular conductance; all P values < 0.01).
CONCLUSIONS


These results demonstrate that incorporating dairy cheese into a high-sodium diet preserves EDD by decreasing the concentration of superoxide radicals. Consuming sodium in cheese, rather than in nondairy sources of sodium, may be an effective strategy to reduce cardiovascular disease risk in salt-insensitive, older adults. This trial was registered at clinicaltrials.gov as NCT03376555.",2020,"Compared with LNa, microvascular responsiveness to ACh was attenuated during HNa (LNa: -4.82 ± 0.20 versus HNa: -3.21 ± 0.55 M logEC50; P = 0.03) but not LNaC (-5.44 ± 0.20 M logEC50) or HNaC (-4.46 ± 0.50 M logEC50).",['11 adults without salt-sensitive blood pressure (<10 mmHg Δ mean arterial pressure; 64\xa0±\xa02 y) 4'],"['High-Dairy Cheese Diet', 'acetylcholine (ACh), both alone and during coinfusion of NG-nitro-L-arginine methyl ester (NO synthase inhibitor), L-ascorbate (nonspecific antioxidant), apocynin [NAD(P)H oxidase inhibitor], or tempol (superoxide scavenger', 'low-sodium, no-dairy intervention (LNa; 1500 mg/d sodium); a low-sodium, high-cheese intervention (LNaC; 1500 mg/d sodium, 170 g/d cheese); a high-sodium, no-dairy intervention (HNa; 5500 mg/d sodium); and a high-sodium, high-cheese intervention (HNaC; 5500 mg/d sodium', 'separate 8-d controlled dietary interventions']",['concentration of superoxide radicals'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0007968', 'cui_str': 'Cheese'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0083536', 'cui_str': 'NG-Nitro-L-Arginine Methyl Ester'}, {'cui': 'C0132555', 'cui_str': 'Nitric Oxide Synthase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0857241', 'cui_str': 'Ascorbate'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0050465', 'cui_str': 'apocynine'}, {'cui': 'C0131722', 'cui_str': 'NADH oxidase'}, {'cui': 'C0045283', 'cui_str': '4-hydroxy-2,2,6,6-tetramethylpiperidinyl-1-oxy'}, {'cui': 'C0038836', 'cui_str': 'Superoxide Anion'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0765942', 'cui_str': 'latent nuclear protein, LNA'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0038836', 'cui_str': 'Superoxide Anion'}]",11.0,0.0228987,"Compared with LNa, microvascular responsiveness to ACh was attenuated during HNa (LNa: -4.82 ± 0.20 versus HNa: -3.21 ± 0.55 M logEC50; P = 0.03) but not LNaC (-5.44 ± 0.20 M logEC50) or HNaC (-4.46 ± 0.50 M logEC50).","[{'ForeName': 'Billie K', 'Initials': 'BK', 'LastName': 'Alba', 'Affiliation': 'Department of Kinesiology, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Stanhewicz', 'Affiliation': 'Department of Kinesiology, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Priyankar', 'Initials': 'P', 'LastName': 'Dey', 'Affiliation': 'Human Nutrition Program, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Bruno', 'Affiliation': 'Human Nutrition Program, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'W Larry', 'Initials': 'WL', 'LastName': 'Kenney', 'Affiliation': 'Department of Kinesiology, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Lacy M', 'Initials': 'LM', 'LastName': 'Alexander', 'Affiliation': 'Department of Kinesiology, The Pennsylvania State University, University Park, PA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxz205']
1864,31495898,Emulsion Droplet Crystallinity Attenuates Postprandial Plasma Triacylglycerol Responses in Healthy Men: A Randomized Double-Blind Crossover Acute Meal Study.,"BACKGROUND


The presence of triacylglycerol (TAG) cystallinity is assumed to influence digestibility and postprandial lipemia (PPL), although studies to date are limited.
OBJECTIVE


This study aimed to investigate whether the presence of solid fat compared with undercooled liquid oil, specifically, plays a role in determining PPL by comparing emulsion droplets differing only in terms of physical state.
METHODS


Ten percent palm stearin and 0.4% sorbitan monostearate emulsions were tempered to contain identically sized, charged, and shaped (spherical) undercooled liquid (LE) compared with partially crystalline solid (SE; mean ± SEM: 33.2% ± 0.03% solid fat at 37°C) droplets. Fifteen healthy fasting adult men (mean ± SD age: 27.5 ± 5.7 y; BMI: 24.1 ± 2.5 kg/m2) consumed 500 mL of each emulsion on separate occasions and plasma TAG concentrations, particle size of the plasma chylomicron-rich fraction (CMRF), and fatty acid (FA) composition of the CMRF-TAG were serially determined in a 6-h postprandial randomized double-blind crossover acute meal study. Changes from baseline values were analyzed by repeated-measures ANOVA.
RESULTS


An earlier (2 compared with 3 h, P < 0.05) significant rise, a 39.9% higher mean postprandial TAG change from baseline (P = 0.08), and higher peak concentration (mean ± SEM: 1.47 ± 0.19 compared with 1.20 ± 0.15 mmol/L, P = 0.04) and iAUC (1.95 ± 0.39 compared with 1.45 ± 0.31 mmol/L × h, P = 0.03) values were observed for LE compared with SE. The compositions of the CMRF-TAG FAs shifted toward those of the ingested palm stearin by 4 h but did not differ between SE and LE (P = 0.90). Nor were there differences in postprandial changes in CMRF particle size (P = 0.79) or nonesterified FAs (P = 0.72) based on lipid physical state.
CONCLUSIONS


Despite their identical compositions and colloidal properties, differences in lipid absorption were observed between SE and LE in healthy adult men. This is direct evidence that TAG physical state contributes to PPL, with the presence of solid fat having an attenuating influence.This trial was registered at clinicaltrials.gov as NCT03515590.",2020,"Nor were there differences in postprandial changes in CMRF particle size (P = 0.79) or nonesterified FAs (P = 0.72) based on lipid physical state.
","['SD age: 27.5\xa0±\xa05.7 y', 'healthy adult men', 'Ten percent palm stearin and 0.4% sorbitan monostearate emulsions', 'Fifteen healthy fasting adult men (mean\xa0±', 'Healthy Men']","['Emulsion Droplet Crystallinity', 'undercooled liquid oil']","['higher peak concentration', 'plasma TAG concentrations, particle size of the plasma chylomicron-rich fraction (CMRF), and fatty acid (FA) composition of the CMRF-TAG', 'postprandial changes in CMRF particle size', 'CMRF-TAG FAs', 'lipid physical state', 'nonesterified FAs', 'lipid absorption', 'Postprandial Plasma Triacylglycerol Responses', 'mean postprandial TAG change']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517674', 'cui_str': '27.5'}, {'cui': 'C4517795', 'cui_str': 'Five point seven'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0230373', 'cui_str': 'Palm of hand (surface region)'}, {'cui': 'C0041111', 'cui_str': 'glyceryl tristearate'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0074915', 'cui_str': 'sorbitan monostearate'}, {'cui': 'C0014020', 'cui_str': 'Emulsions'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C0014020', 'cui_str': 'Emulsions'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C0028908', 'cui_str': 'Oils'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0037293', 'cui_str': 'Tag (morphologic abnormality)'}, {'cui': 'C0030608', 'cui_str': 'Particle Size'}, {'cui': 'C0008731', 'cui_str': 'Chylomicrons'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",15.0,0.362086,"Nor were there differences in postprandial changes in CMRF particle size (P = 0.79) or nonesterified FAs (P = 0.72) based on lipid physical state.
","[{'ForeName': 'Surangi H', 'Initials': 'SH', 'LastName': 'Thilakarathna', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Samar', 'Initials': 'S', 'LastName': 'Hamad', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Cuncins', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Wright', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, Canada.'}]",The Journal of nutrition,['10.1093/jn/nxz207']
1865,31846016,Effect of a Strategy of Comprehensive Vasodilation vs Usual Care on Mortality and Heart Failure Rehospitalization Among Patients With Acute Heart Failure: The GALACTIC Randomized Clinical Trial.,"Importance


Short-term infusions of single vasodilators, usually given in a fixed dose, have not improved outcomes in patients with acute heart failure (AHF).
Objective


To evaluate the effect of a strategy that emphasized early intensive and sustained vasodilation using individualized up-titrated doses of established vasodilators in patients with AHF.
Design, Setting, and Participants


Randomized, open-label blinded-end-point trial enrolling 788 patients hospitalized for AHF with dyspnea, increased plasma concentrations of natriuretic peptides, systolic blood pressure of at least 100 mm Hg, and plan for treatment in a general ward in 10 tertiary and secondary hospitals in Switzerland, Bulgaria, Germany, Brazil, and Spain. Enrollment began in December 2007 and follow-up was completed in February 2019.
Interventions


Patients were randomized 1:1 to a strategy of early intensive and sustained vasodilation throughout the hospitalization (n = 386) or usual care (n = 402). Early intensive and sustained vasodilation was a comprehensive pragmatic approach of maximal and sustained vasodilation combining individualized doses of sublingual and transdermal nitrates, low-dose oral hydralazine for 48 hours, and rapid up-titration of angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, or sacubitril-valsartan.
Main Outcomes and Measures


The primary end point was a composite of all-cause mortality or rehospitalization for AHF at 180 days.
Results


Among 788 patients randomized, 781 (99.1%; median age, 78 years; 36.9% women) completed the trial and were eligible for primary end point analysis. Follow-up at 180 days was completed for 779 patients (99.7%). The primary end point, a composite of all-cause mortality or rehospitalization for AHF at 180 days, occurred in 117 patients (30.6%) in the intervention group (including 55 deaths [14.4%]) and in 111 patients (27.8%) in the usual care group (including 61 deaths [15.3%]) (absolute difference for the primary end point, 2.8% [95% CI, -3.7% to 9.3%]; adjusted hazard ratio, 1.07 [95% CI, 0.83-1.39]; P = .59). The most common clinically significant adverse events with early intensive and sustained vasodilation vs usual care were hypokalemia (23% vs 25%), worsening renal function (21% vs 20%), headache (26% vs 10%), dizziness (15% vs 10%), and hypotension (8% vs 2%).
Conclusions and Relevance


Among patients with AHF, a strategy of early intensive and sustained vasodilation, compared with usual care, did not significantly improve a composite outcome of all-cause mortality and AHF rehospitalization at 180 days.
Trial Registration


ClinicalTrials.gov Identifier: NCT00512759.",2019,"The primary end point, a composite of all-cause mortality or rehospitalization for AHF at 180 days, occurred in 117 patients (30.6%) in the intervention group (including 55 deaths [14.4%]) and in 111 patients (27.8%) in the usual care group (including 61 deaths [15.3%]) (absolute difference for the primary end point, 2.8% [95% CI, -3.7% to 9.3%]; adjusted hazard ratio, 1.07 [95% CI, 0.83-1.39]; P = .59).","['patients with AHF', '788 patients randomized, 781 (99.1%; median age, 78 years; 36.9% women', 'patients with acute heart failure (AHF', 'Patients With Acute Heart Failure', '788 patients hospitalized for AHF with dyspnea, increased plasma concentrations of natriuretic peptides, systolic blood pressure of at least 100 mm Hg, and plan for treatment in a general ward in 10 tertiary and secondary hospitals in Switzerland, Bulgaria, Germany, Brazil, and Spain']","['Comprehensive Vasodilation vs Usual Care', 'strategy of early intensive and sustained vasodilation throughout the hospitalization (n\u2009=\u2009386) or usual care', 'sublingual and transdermal nitrates, low-dose oral hydralazine', 'angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, or sacubitril-valsartan']","['Mortality and Heart Failure Rehospitalization', 'hypotension', 'hypokalemia', 'composite of all-cause mortality or rehospitalization for AHF', 'dizziness', 'headache', 'worsening renal function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015506', 'cui_str': 'coagulation factor VIII'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure (disorder)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptides'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0043030', 'cui_str': 'Wards, General'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0006368', 'cui_str': 'Bulgaria'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0042401', 'cui_str': 'Vasorelaxation'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C4521982', 'cui_str': 'Sublingual'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0020223', 'cui_str': 'Hydralazine'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor (substance)'}, {'cui': 'C4033631', 'cui_str': 'sacubitril / valsartan'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0020621', 'cui_str': 'Hypopotassemia'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0015506', 'cui_str': 'coagulation factor VIII'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}]",788.0,0.189306,"The primary end point, a composite of all-cause mortality or rehospitalization for AHF at 180 days, occurred in 117 patients (30.6%) in the intervention group (including 55 deaths [14.4%]) and in 111 patients (27.8%) in the usual care group (including 61 deaths [15.3%]) (absolute difference for the primary end point, 2.8% [95% CI, -3.7% to 9.3%]; adjusted hazard ratio, 1.07 [95% CI, 0.83-1.39]; P = .59).","[{'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Kozhuharov', 'Affiliation': 'Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Assen', 'Initials': 'A', 'LastName': 'Goudev', 'Affiliation': 'Queen Ioanna University Hospital Sofia, Department of Cardiology, Medical University of Sofia, Sofia, Bulgaria.'}, {'ForeName': 'Dayana', 'Initials': 'D', 'LastName': 'Flores', 'Affiliation': 'Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Micha T', 'Initials': 'MT', 'LastName': 'Maeder', 'Affiliation': 'Department of Cardiology, Kantonsspital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Walter', 'Affiliation': 'Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Samyut', 'Initials': 'S', 'LastName': 'Shrestha', 'Affiliation': 'Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Danielle Menosi', 'Initials': 'DM', 'LastName': 'Gualandro', 'Affiliation': 'Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Mucio Tavares', 'Initials': 'MT', 'LastName': 'de Oliveira Junior', 'Affiliation': 'Heart Institute (INCOR), University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Zaid', 'Initials': 'Z', 'LastName': 'Sabti', 'Affiliation': 'Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Müller', 'Affiliation': 'Department of General Internal and Emergency Medicine, Medical University Clinic of the University of Basel, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Noveanu', 'Affiliation': 'Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Thenral', 'Initials': 'T', 'LastName': 'Socrates', 'Affiliation': 'Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Ronny', 'Initials': 'R', 'LastName': 'Ziller', 'Affiliation': 'Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Bayés-Genís', 'Affiliation': 'Heart Institute, Hospital Universitari Germans Trias i Pujol, CIBERCV, Department of Medicine, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Sionis', 'Affiliation': 'Intensive Cardiac Care Unit, Cardiology Department, Hospital de la Santa Creu i Sant Pau, Biomedical Research Institute IIB-Sant Pau, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Simon', 'Affiliation': 'Clinical Trial Unit, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Michou', 'Affiliation': 'Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Gujer', 'Affiliation': 'Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Gori', 'Affiliation': 'University Medical Center, Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Wenzel', 'Affiliation': 'University Medical Center, Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Otmar', 'Initials': 'O', 'LastName': 'Pfister', 'Affiliation': 'Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Conen', 'Affiliation': 'Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Kapos', 'Affiliation': 'Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kobza', 'Affiliation': 'Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Rickli', 'Affiliation': 'Department of Cardiology, Kantonsspital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Breidthardt', 'Affiliation': 'Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Münzel', 'Affiliation': 'University Medical Center, Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Erne', 'Affiliation': 'Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mueller', 'Affiliation': 'Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': '', 'LastName': 'Mueller', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': '', 'LastName': 'Erne', 'Affiliation': ''}, {'ForeName': 'Beat', 'Initials': '', 'LastName': 'Müller', 'Affiliation': ''}, {'ForeName': 'Hans', 'Initials': '', 'LastName': 'Rickli', 'Affiliation': ''}, {'ForeName': 'Micha', 'Initials': '', 'LastName': 'Maeder', 'Affiliation': ''}, {'ForeName': 'Mucio', 'Initials': '', 'LastName': 'Tavares de Oliveira', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': '', 'LastName': 'Münzel', 'Affiliation': ''}, {'ForeName': 'Antoni', 'Initials': '', 'LastName': 'Bayés-Genís', 'Affiliation': ''}, {'ForeName': 'Alessandro', 'Initials': '', 'LastName': 'Sionis', 'Affiliation': ''}, {'ForeName': 'Assen', 'Initials': '', 'LastName': 'Goudev', 'Affiliation': ''}, {'ForeName': 'Bojidar', 'Initials': '', 'LastName': 'Dimov', 'Affiliation': ''}, {'ForeName': 'Sabine', 'Initials': '', 'LastName': 'Hartwiger', 'Affiliation': ''}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Arenja', 'Affiliation': ''}, {'ForeName': 'Bettina', 'Initials': '', 'LastName': 'Glatz', 'Affiliation': ''}, {'ForeName': 'Natascha', 'Initials': '', 'LastName': 'Herr', 'Affiliation': ''}, {'ForeName': 'Rahel', 'Initials': '', 'LastName': 'Isenrich', 'Affiliation': ''}, {'ForeName': 'Tamina', 'Initials': '', 'LastName': 'Mosimann', 'Affiliation': ''}, {'ForeName': 'Raphael', 'Initials': '', 'LastName': 'Twerenbold', 'Affiliation': ''}, {'ForeName': 'Jasper', 'Initials': '', 'LastName': 'Boeddinghaus', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': '', 'LastName': 'Nestelberger', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': '', 'LastName': 'Puelacher', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': '', 'LastName': 'Freese', 'Affiliation': ''}, {'ForeName': 'Janine', 'Initials': '', 'LastName': 'Vögele', 'Affiliation': ''}, {'ForeName': 'Kathrin', 'Initials': '', 'LastName': 'Meissner', 'Affiliation': ''}, {'ForeName': 'Jasmin', 'Initials': '', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'Ivo', 'Initials': '', 'LastName': 'Strebel', 'Affiliation': ''}, {'ForeName': 'Desiree', 'Initials': '', 'LastName': 'Wussler', 'Affiliation': ''}, {'ForeName': 'Carmela', 'Initials': '', 'LastName': 'Schumacher', 'Affiliation': ''}, {'ForeName': 'Stefan', 'Initials': '', 'LastName': 'Osswald', 'Affiliation': ''}, {'ForeName': 'Fabian', 'Initials': '', 'LastName': 'Vogt', 'Affiliation': ''}, {'ForeName': 'Jonas', 'Initials': '', 'LastName': 'Hilti', 'Affiliation': ''}, {'ForeName': 'Sara', 'Initials': '', 'LastName': 'Barata', 'Affiliation': ''}, {'ForeName': 'Deborah', 'Initials': '', 'LastName': 'Schneider', 'Affiliation': ''}, {'ForeName': 'Jonas', 'Initials': '', 'LastName': 'Schwarz', 'Affiliation': ''}, {'ForeName': 'Brigitte', 'Initials': '', 'LastName': 'Fitze', 'Affiliation': ''}, {'ForeName': 'Sabine', 'Initials': '', 'LastName': 'Hartwiger', 'Affiliation': ''}, {'ForeName': 'Nisha', 'Initials': '', 'LastName': 'Arenja', 'Affiliation': ''}, {'ForeName': 'Bettina', 'Initials': '', 'LastName': 'Glatz', 'Affiliation': ''}, {'ForeName': 'Natascha', 'Initials': '', 'LastName': 'Herr', 'Affiliation': ''}, {'ForeName': 'Rahel', 'Initials': '', 'LastName': 'Isenrich', 'Affiliation': ''}, {'ForeName': 'Tamina', 'Initials': '', 'LastName': 'Mosimann', 'Affiliation': ''}, {'ForeName': 'Raphael', 'Initials': '', 'LastName': 'Twerenbold', 'Affiliation': ''}, {'ForeName': 'Jasper', 'Initials': '', 'LastName': 'Boeddinghaus', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': '', 'LastName': 'Nestelberger', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': '', 'LastName': 'Puelacher', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': '', 'LastName': 'Freese', 'Affiliation': ''}, {'ForeName': 'Janine', 'Initials': '', 'LastName': 'Vögele', 'Affiliation': ''}, {'ForeName': 'Kathrin', 'Initials': '', 'LastName': 'Meissner', 'Affiliation': ''}, {'ForeName': 'Jasmin', 'Initials': '', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'Ivo', 'Initials': '', 'LastName': 'Strebel', 'Affiliation': ''}, {'ForeName': 'Desiree', 'Initials': '', 'LastName': 'Wussler', 'Affiliation': ''}, {'ForeName': 'Carmela', 'Initials': '', 'LastName': 'Schumacher', 'Affiliation': ''}, {'ForeName': 'Stefan', 'Initials': '', 'LastName': 'Osswald', 'Affiliation': ''}, {'ForeName': 'Fabian', 'Initials': '', 'LastName': 'Vogt', 'Affiliation': ''}, {'ForeName': 'Jonas', 'Initials': '', 'LastName': 'Hilti', 'Affiliation': ''}, {'ForeName': 'Sara', 'Initials': '', 'LastName': 'Barata', 'Affiliation': ''}, {'ForeName': 'Deborah', 'Initials': '', 'LastName': 'Schneider', 'Affiliation': ''}, {'ForeName': 'Jonas', 'Initials': '', 'LastName': 'Schwarz', 'Affiliation': ''}, {'ForeName': 'Brigitte', 'Initials': '', 'LastName': 'Fitze', 'Affiliation': ''}, {'ForeName': 'Nisha', 'Initials': '', 'LastName': 'Arenja', 'Affiliation': ''}, {'ForeName': 'Katharina', 'Initials': '', 'LastName': 'Rentsch', 'Affiliation': ''}, {'ForeName': 'Aline', 'Initials': '', 'LastName': 'Bossa', 'Affiliation': ''}, {'ForeName': 'Sergio', 'Initials': '', 'LastName': 'Jallad', 'Affiliation': ''}, {'ForeName': 'Alexandre', 'Initials': '', 'LastName': 'Soeiro', 'Affiliation': ''}, {'ForeName': 'Dimitar', 'Initials': '', 'LastName': 'Georgiev', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': '', 'LastName': 'Jansen', 'Affiliation': ''}, {'ForeName': 'Gabriele', 'Initials': '', 'LastName': 'Gebel', 'Affiliation': ''}, {'ForeName': 'Matthias', 'Initials': '', 'LastName': 'Bossard', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': '', 'LastName': 'Christ', 'Affiliation': ''}]",JAMA,['10.1001/jama.2019.18598']
1866,31846094,"Health utility of rhinectomy, surgical nasal reconstruction, and prosthetic rehabilitation.","OBJECTIVES


Advanced nasal malignancies may require rhinectomy, which can have profound psychosocial impacts. Rhinectomy defects can be rehabilitated through surgery or prosthetics. We seek to understand the health utility of the rhinectomy defect, surgical, and prosthetic reconstruction, which have not been previously studied.
STUDY DESIGN


Prospective clinical study METHODS: Adult naïve observers (n = 273) ranked the utility of five randomized health states (monocular blindness, binocular blindness, post-rhinectomy nasal defect, postsurgical reconstruction, and post-prosthetic rehabilitation). Health utilities were measured using visual analogue scale (VAS), standard gamble (SG), and time trade-off (TTO). One-way analysis of variance (ANOVA) with post hoc Scheffe's test and the independent samples T-test for a priori comparisons were performed. Multiple linear regression was performed using participant demographics as independent predictors of utility scores.
RESULTS


Health utilities (VAS, SG, TTO) were reported as follows (mean ± SD): monocular blindness (0.71 ± 0.21, 0.84 ± 0.20, 0.85 ± 0.19), binocular blindness (0.48 ± 0.25, 0.68 ± 0.28, 0.63 ± 0.28), post-rhinectomy nasal defect (0.59 ± 0.24, 0.74 ± 0.24, 0.74 ± 0.24), postsurgical reconstruction (0.88 ± 0.16, 0.90 ± 0.18, 0.89 ± 0.13), and post-prosthetic rehabilitation (0.67 ± 0.22, 0.80 ± 0.23, 0.82 ± 0.20). Both surgical reconstruction (P < .001) and prosthetic rehabilitation (P < .001) significantly improved health utility. SG and TTO utility scores were inversely associated with observer age (P < .001) and participants who identified themselves as non-Caucasians (P < .05) in post-rhinectomy nasal defect, post-nasal surgical reconstruction, and post-nasal prosthetic rehabilitation health states, while higher levels of education were directly associated with SG scores (P < .05), respectively.
CONCLUSION


This is the first study to demonstrate the significant negative impact of the rhinectomy nasal defect on health utility. Rehabilitation by surgical or prosthetic techniques significantly increases health utility as rated by naïve observers. Laryngoscope, 130:1674-1679, 2020.",2020,Both surgical reconstruction (P < .001) and prosthetic rehabilitation (P < .001) significantly improved health utility.,"['Adult naïve observers (n = 273) ranked the utility of five randomized health states (monocular blindness, binocular blindness, post-rhinectomy nasal defect, postsurgical reconstruction, and post-prosthetic rehabilitation']","['rhinectomy, surgical nasal reconstruction, and prosthetic rehabilitation']","['prosthetic rehabilitation', 'SG scores', 'visual analogue scale (VAS), standard gamble (SG), and time trade-off (TTO', 'Health utilities (VAS, SG, TTO', 'postsurgical reconstruction', 'SG and TTO utility scores', 'Health utilities', 'health utility', 'binocular blindness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0699794', 'cui_str': 'Rank (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0750958', 'cui_str': 'Blindness, Monocular'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0176364', 'cui_str': 'Total rhinectomy (procedure)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0556028', 'cui_str': 'Prosthetic rehabilitation (regime/therapy)'}]","[{'cui': 'C0176364', 'cui_str': 'Total rhinectomy (procedure)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0556028', 'cui_str': 'Prosthetic rehabilitation (regime/therapy)'}]","[{'cui': 'C0556028', 'cui_str': 'Prosthetic rehabilitation (regime/therapy)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]",,0.0331634,Both surgical reconstruction (P < .001) and prosthetic rehabilitation (P < .001) significantly improved health utility.,"[{'ForeName': 'Callum', 'Initials': 'C', 'LastName': 'Faris', 'Affiliation': 'Department of Otolaryngology, University of Antwerp Medical Center, Antwerp, Belgium, U.S.A.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Heiser', 'Affiliation': 'Division of Facial Plastic and Reconstructive Surgery Massachusetts Eye and Ear, Harvard Medical School, Boston, Massachusetts, U.S.A.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Quatela', 'Affiliation': 'Division of Facial Plastic and Reconstructive Surgery Massachusetts Eye and Ear, Harvard Medical School, Boston, Massachusetts, U.S.A.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Jackson', 'Affiliation': 'Department of Otolaryngology Head & Neck Surgery, Massachusetts Eye and Ear, Harvard Medical School, Boston, Massachusetts, U.S.A.'}, {'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Tessler', 'Affiliation': 'Elite Plastic Surgery, Phoenix, Arizona, U.S.A.'}, {'ForeName': 'Nate', 'Initials': 'N', 'LastName': 'Jowett', 'Affiliation': 'Department of Otolaryngology, University of Antwerp Medical Center, Antwerp, Belgium, U.S.A.'}, {'ForeName': 'Linda N', 'Initials': 'LN', 'LastName': 'Lee', 'Affiliation': 'Division of Facial Plastic and Reconstructive Surgery Massachusetts Eye and Ear, Harvard Medical School, Boston, Massachusetts, U.S.A.'}]",The Laryngoscope,['10.1002/lary.28480']
1867,31500524,Cerebrovascular effects of endothelin-1 investigated using high-resolution magnetic resonance imaging in healthy volunteers.,"Endothelin-1 (ET-1) is a highly potent vasoconstrictor peptide released from vascular endothelium. ET-1 plays a major role in cerebrovascular disorders and likely worsens the outcome of acute ischaemic stroke and aneurismal subarachnoid haemorrhage through vasoconstriction and cerebral blood flow (CBF) reduction. Disorders that increase the risk of stroke, including hypertension, diabetes mellitus, and acute myocardial infarction, are associated with increased plasma levels of ET-1. The in vivo human cerebrovascular effects of systemic ET-1 infusion have not previously been investigated. In a two-way crossover, randomized, double-blind design, we used advanced 3 tesla MRI methods to investigate the effects of high-dose intravenous ET-1 on intra- and extracranial artery circumferences, global and regional CBF, and cerebral metabolic rate of oxygen (CMRO 2 ) in 14 healthy volunteers. Following ET-1 infusion, we observed a 14% increase of mean arterial blood pressure, a 5% decrease of middle cerebral artery (MCA) circumference, but no effects on extracerebral arteries and no effects on CBF or CMRO 2 . Collectively, the findings indicate MCA constriction secondarily to blood pressure increase and not due to a direct vasoconstrictor effect of ET-1. We suggest that, as opposed to ET-1 in the subarachnoid space, intravascular ET-1 does not exert direct cerebrovascular effects in humans.",2019,"Following ET-1 infusion, we observed a 14% increase of mean arterial blood pressure, a 5% decrease of middle cerebral artery (MCA) circumference, but no effects on extracerebral arteries and no effects on CBF or CMRO 2 .","['14 healthy volunteers', 'healthy volunteers']","['Endothelin-1 (ET-1', 'endothelin-1 investigated using high-resolution magnetic resonance imaging']","['blood pressure increase', 'intra- and extracranial artery circumferences, global and regional CBF, and cerebral metabolic rate of oxygen (CMRO 2 ', 'risk of stroke, including hypertension, diabetes mellitus, and acute myocardial infarction', 'mean arterial blood pressure', 'middle cerebral artery (MCA) circumference']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0497247', 'cui_str': 'Finding of increased blood pressure (finding)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0580586', 'cui_str': 'Extracranial (qualifier value)'}, {'cui': 'C0003842', 'cui_str': 'Arteries'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0149566', 'cui_str': 'Middle Cerebral Artery'}]",14.0,0.171039,"Following ET-1 infusion, we observed a 14% increase of mean arterial blood pressure, a 5% decrease of middle cerebral artery (MCA) circumference, but no effects on extracerebral arteries and no effects on CBF or CMRO 2 .","[{'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Hougaard', 'Affiliation': 'Department of Neurology, Danish Headache Center, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Samaira', 'Initials': 'S', 'LastName': 'Younis', 'Affiliation': 'Department of Neurology, Danish Headache Center, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Afrim', 'Initials': 'A', 'LastName': 'Iljazi', 'Affiliation': 'Department of Neurology, Danish Headache Center, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Kristian A', 'Initials': 'KA', 'LastName': 'Haanes', 'Affiliation': 'Department of Clinical Experimental Research, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Lindberg', 'Affiliation': 'Department of Clinical Physiology, Functional Imaging Unit, Nuclear Medicine and PET, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Vestergaard', 'Affiliation': 'Department of Clinical Physiology, Functional Imaging Unit, Nuclear Medicine and PET, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Faisal M', 'Initials': 'FM', 'LastName': 'Amin', 'Affiliation': 'Department of Neurology, Danish Headache Center, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Kazutaka', 'Initials': 'K', 'LastName': 'Sugimoto', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Charlestown, USA.'}, {'ForeName': 'Lars S', 'Initials': 'LS', 'LastName': 'Kruse', 'Affiliation': 'Department of Clinical Experimental Research, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Cenk', 'Initials': 'C', 'LastName': 'Ayata', 'Affiliation': 'Stroke Service, Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Charlestown, USA.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Department of Neurology, Danish Headache Center, Rigshospitalet Glostrup, Glostrup, Denmark.'}]",Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism,['10.1177/0271678X19874295']
1868,31498467,Role of voice rest following laser resection of vocal fold lesions: A randomized controlled trial.,"OBJECTIVES/HYPOTHESIS


Voice rest is often prescribed following phonosurgery by most surgeons despite limited empiric evidence to support its practice. This study assessed the effect of postphonosurgery voice rest on vocal outcomes.
STUDY DESIGN


Prospective, randomized controlled trial.
METHODS


Patients with unilateral vocal fold lesions undergoing CO 2  laser excision were recruited in a prospective manner and randomized into one of two groups: 1) an experimental arm consisting of 7 days of absolute voice rest, or 2) a control arm consisting of no voice rest. The primary outcome measure was the Voice Handicap Index-10 (VHI-10) questionnaire. Secondary outcomes included aerodynamic measurements (maximum phonation time), acoustic measures (fundamental frequency, jitter, shimmer, and harmonic-to-noise ratio), and auditory-perceptual measures. Primary and secondary outcomes were assessed preoperatively and reassessed postoperatively at the 1- and 3-month follow-up. Patient compliance to voice rest instructions were controlled for using subjective and objective parameters.
RESULTS


Thirty patients were enrolled with 15 randomized to each arm of the study. Statistical analysis for the entire cohort showed a significant improvement in the mean preoperative VHI-10 compared to postoperative assessments at 1-month (19.0 vs. 7.3, P < .05) and 3-month (19.0 vs. 6.2, P < .05) follow-up. However, between-group comparisons showed no significant difference in postoperative VHI-10 at either time point. Similarly, secondary outcome measures yielded no significant difference in between-group comparisons.
CONCLUSIONS


Our study shows no significant benefit to voice rest on postoperative voice outcomes as determined by patient self-perception, acoustic variables, and auditory-perceptual analysis.
LEVEL OF EVIDENCE


1b CLINICAL TRIAL NUMBER: NCT02788435 (clinicaltrials.gov) Laryngoscope, 130:1750-1755, 2020.",2020,"Our study shows no significant benefit to voice rest on postoperative voice outcomes as determined by patient self-perception, acoustic variables, and auditory-perceptual analysis.
","['Thirty patients were enrolled with 15 randomized to each arm of the study', 'Patients with unilateral vocal fold lesions undergoing CO 2  laser excision', 'vocal fold lesions']","['absolute voice rest, or 2) a control arm consisting of no voice rest', 'postphonosurgery voice rest', 'laser resection']","['postoperative VHI-10', 'Voice Handicap Index-10 (VHI-10) questionnaire', 'mean preoperative VHI-10', 'aerodynamic measurements (maximum phonation time), acoustic measures (fundamental frequency, jitter, shimmer, and harmonic-to-noise ratio), and auditory-perceptual measures']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0042930', 'cui_str': 'Vocal Fold'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2985106', 'cui_str': 'Voice handicap index (assessment scale)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0234778', 'cui_str': 'Maximum phonation time (observable entity)'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}]",30.0,0.185901,"Our study shows no significant benefit to voice rest on postoperative voice outcomes as determined by patient self-perception, acoustic variables, and auditory-perceptual analysis.
","[{'ForeName': 'Sandeep S', 'Initials': 'SS', 'LastName': 'Dhaliwal', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Western University, London, Ontario, Canada.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Doyle', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Western University, London, Ontario, Canada.'}, {'ForeName': 'Sebastiano', 'Initials': 'S', 'LastName': 'Failla', 'Affiliation': 'Voice Production and Perception Laboratory, and Department of Health and Rehabilitation Sciences, Western University, London, Ontario, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hawkins', 'Affiliation': 'Department of Speech-Language Pathology, London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Fung', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Western University, London, Ontario, Canada.'}]",The Laryngoscope,['10.1002/lary.28287']
1869,32436641,"Ultrarapid lispro lowers postprandial glucose and more closely matches normal physiological glucose response compared to other rapid insulin analogues: A phase 1 randomized, crossover study.","AIMS


To compare the pharmacokinetic (PK) and glucodynamic (GD) characteristics of ultra rapid lispro (URLi; Eli Lilly and Company, Indianapolis, Indiana), Fiasp® (Novo Nordisk, Bagsvaerd, Denmark), Humalog® (Eli Lilly and Company) and NovoRapid® (Novo Nordisk), in patients with type 1 diabetes (T1D).
MATERIALS AND METHODS


This was a randomized, double-blind, four-period, crossover study, conducted in 68 patients with T1D. Patients received the same individualized subcutaneous dose of each study drug immediately prior to a liquid test meal. For comparison, 12 healthy subjects received the same test meal.
RESULTS


URLi had a significantly faster insulin absorption compared to the other insulins tested. Early half-maximal drug concentration was reached 13 minutes after administration of URLi, which was 6 minutes faster than Fiasp, 13 minutes faster than Humalog, and 14 minutes faster than NovoRapid (all P <0.0001). Early insulin exposure was significantly greater and late insulin exposure was reduced after URLi compared to the other insulins. URLi achieved the greatest numerical reduction in postprandial glucose (PPG) at 2 hours post-meal (7 mg/dL vs Fiasp) and was significantly different from Humalog (21 mg/dL) and Novo Rapid (29 mg/dL). Additionally, glucose excursions over the first 3 hours post-meal with URLi were comparable to those in healthy subjects.
CONCLUSIONS


URLi demonstrated the fastest insulin absorption and the greatest numeric PPG-lowering effect compared to the other insulins tested. URLi more closely matched the early physiological glucose control observed in healthy subjects.",2020,URLi achieved the greatest numerical reduction in PPG at 2 hours post-meal (7 mg/dL vs Fiasp) and significant differences to Humalog (21 mg/dL) and Novo Rapid (29 mg/dL).,"['68 patients with T1D. Patients', 'patients with type 1 diabetes (T1D', '12 healthy subjects', 'healthy subjects']","['URLi', 'pharmacokinetics (PK) and glucocodynamics (GD) of URLi, Fiasp®, Humalog®, and NovoRapid®', 'Ultra rapid lispro (URLi']","['Ultra Rapid Lispro Lowers Postprandial Glucose and More Closely Matches Normal Physiological Glucose Response', 'insulin absorption', 'maximal drug concentration', 'glucose excursions', 'postprandial glucose (PPG) control', 'late insulin exposure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C4529885', 'cui_str': 'Fiasp'}, {'cui': 'C0528249', 'cui_str': 'Humalog'}, {'cui': 'C0939412', 'cui_str': 'NovoRapid'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",68.0,0.0670366,URLi achieved the greatest numerical reduction in PPG at 2 hours post-meal (7 mg/dL vs Fiasp) and significant differences to Humalog (21 mg/dL) and Novo Rapid (29 mg/dL).,"[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Heise', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Linnebjerg', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Coutant', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'LaBell', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Zijlstra', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kapitza', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Bue-Valleskey', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Qianyi', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Mary Anne', 'Initials': 'MA', 'LastName': 'Dellva', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Leohr', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14094']
1870,31418808,Effect of Primary Care Parent-Targeted Interventions on Parent-Adolescent Communication About Sexual Behavior and Alcohol Use: A Randomized Clinical Trial.,"Importance


Adolescent well care visits provide opportunities for clinicians to facilitate parent-adolescent communication (PAC) to reduce pregnancy, sexually transmitted infections, and alcohol-related harm among adolescents.
Objective


To test the effect of brief parent-targeted interventions delivered in primary care settings on PAC about sexual and alcohol use behaviors.
Design, Setting, and Participants


Randomized clinical trial conducted at a primary care pediatric practice from January 4, 2016, to April 10, 2017. Adolescents who were scheduled for a well care visit were recruited, along with their parent or guardian. Data analyses continued through April 30, 2018.
Interventions


During well care visits, parents in sexual health intervention and alcohol prevention intervention groups received coaching to discuss written intervention materials encouraging PAC about sex or alcohol, respectively, with their adolescent within 2 weeks, followed by a brief clinician endorsement. After 2 weeks, parents received a follow-up telephone call. Control group parents received usual care.
Main Outcomes and Measures


Participants were surveyed 4 months after the well care visit. Parent-reported and adolescent-reported quality of PAC was measured using the 20-item Parent-Adolescent Communication Scale, in which a higher score indicates better PAC; and frequency of PAC about sex or alcohol was measured using a 4-point Likert-type scale with 1 indicating not at all or never, and 4 indicating a lot or often.
Results


Of 196 parent-adolescent dyads assessed for eligibility, 118 (60.2%) were eligible to participate. These 118 dyads were randomized to 1 of 3 groups: (1) sexual health intervention (n = 38 [32.2%]); (2) alcohol prevention intervention (n = 40 [33.9%]); and control (n = 40 [33.9%]); 104 parents (88.1%) and 99 adolescents (83.9%) completed the study. Parents included 112 women (94.9%) and had a mean (SD) age of 45.8 (6.9) years. Adolescents included 60 girls (50.9%); 67 adolescents (56.8%) were aged 14 years, and 51 adolescents (43.2%) were aged 15 years. Participant race/ethnicity reflected that of the practice (63 black adolescents [53.4%]; 46 white adolescents [38.9%]; 111 non-Hispanic adolescents [94.1%]). At baseline, 15 adolescents (12.7%) reported a history of sexual behavior and 16 adolescents (13.6%) reported a history of alcohol use. Intention-to-treat analyses found that 4 months after the intervention, adolescents in the sexual health intervention group reported a higher mean frequency score for PAC about sex compared with those in the control group (2.32 [95% CI, 1.97-2.66] vs 1.79 [95% CI, 1.50-2.08]; P = .02); adolescents in the alcohol prevention intervention group reported a higher mean frequency score for PAC about alcohol compared with those in the control group (2.93 [95% CI, 2.60-3.25] vs 2.40 [95% CI, 2.08-2.72]; P = .03). Parent-reported frequency scores for PAC about sex or alcohol did not differ by group.
Conclusions and Relevance


Brief parent-targeted interventions in primary care settings increased adolescent-reported frequency of PAC about sexual health and alcohol use and may be an important strategy for parents to influence adolescent behaviors and health outcomes.
Trial Registration


ClinicalTrials.gov identifier: NCT02554682.",2019,"P = .02); adolescents in the alcohol prevention intervention group reported a higher mean frequency score for PAC about alcohol compared with those in the control group (2.93 [95% CI, 2.60-3.25] vs 2.40 [95% CI, 2.08-2.72]; P = .03).","['n\u2009=\u200940 [33.9%]); and control (n\u2009=\u200940 [33.9%]); 104 parents (88.1%) and 99 adolescents (83.9%) completed the study', 'Parent-Adolescent Communication About Sexual Behavior and Alcohol Use', '196 parent-adolescent dyads assessed for eligibility, 118 (60.2%) were eligible to participate', 'primary care pediatric practice from January 4, 2016, to April 10, 2017', 'Adolescents who were scheduled for a well care visit were recruited, along with their parent or guardian', '63 black adolescents [53.4%]; 46 white adolescents [38.9%]; 111 non-Hispanic adolescents [94.1', 'Adolescents included 60 girls (50.9%); 67 adolescents (56.8%) were aged 14 years, and 51 adolescents (43.2%) were aged 15 years', '118 dyads', 'Parents included 112 women (94.9%) and had a mean (SD) age of 45.8 (6.9) years']","['coaching to discuss written intervention materials encouraging PAC about sex or alcohol', 'usual care', 'Primary Care Parent-Targeted Interventions', 'sexual health intervention', 'alcohol prevention intervention']","['quality of PAC', 'mean frequency score for PAC about sex', 'history of alcohol use', 'mean frequency score for PAC about alcohol', 'history of sexual behavior']","[{'cui': 'C4517718', 'cui_str': '33.9'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1274041', 'cui_str': 'Guardian'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}]","[{'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0182281', 'cui_str': 'Picture Archiving and Communication Systems'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0182281', 'cui_str': 'Picture Archiving and Communication Systems'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}]",60.0,0.0649916,"P = .02); adolescents in the alcohol prevention intervention group reported a higher mean frequency score for PAC about alcohol compared with those in the control group (2.93 [95% CI, 2.60-3.25] vs 2.40 [95% CI, 2.08-2.72]; P = .03).","[{'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Ford', 'Affiliation': ""Perelman School of Medicine, Department of Pediatrics, Division of Adolescent Medicine, University of Pennsylvania, Children's Hospital of Philadelphia, Philadelphia.""}, {'ForeName': 'Jessica H', 'Initials': 'JH', 'LastName': 'Mirman', 'Affiliation': 'Department of Psychology, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'J Felipe', 'Initials': 'JF', 'LastName': 'García-España', 'Affiliation': ""Perelman School of Medicine, Department of Pediatrics, Division of Adolescent Medicine, University of Pennsylvania, Children's Hospital of Philadelphia, Philadelphia.""}, {'ForeName': 'Megan C', 'Initials': 'MC', 'LastName': 'Fisher Thiel', 'Affiliation': ""Perelman School of Medicine, Department of Pediatrics, Division of Adolescent Medicine, University of Pennsylvania, Children's Hospital of Philadelphia, Philadelphia.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Friedrich', 'Affiliation': ""Perelman School of Medicine, Department of Pediatrics, Division of Adolescent Medicine, University of Pennsylvania, Children's Hospital of Philadelphia, Philadelphia.""}, {'ForeName': 'Elyse C', 'Initials': 'EC', 'LastName': 'Salek', 'Affiliation': ""Perelman School of Medicine, Department of Pediatrics, Division of Adolescent Medicine, University of Pennsylvania, Children's Hospital of Philadelphia, Philadelphia.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Jaccard', 'Affiliation': 'Silver School of Social Work, New York University, New York.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.9535']
1871,31418805,Effect of Bismuth Subsalicylate vs Placebo on Use of Antibiotics Among Adult Outpatients With Diarrhea in Pakistan: A Randomized Clinical Trial.,"Importance


Many of the 4.5 billion annual episodes of diarrhea are treated unnecessarily with antibiotics; prevalence of antibiotic resistance among diarrheal pathogens is increasing. Knowledge-based antibiotic stewardship interventions typically yield little change in antibiotic use.
Objective


To compare antibiotic use among adult outpatients with diarrhea given bismuth subsalicylate (BSS) or placebo.
Design, Setting, and Participants


This randomized clinical trial took place from April to October 2014. Participants were patients aged 15 to 65 years with acute, nonbloody diarrhea from 22 outpatient clinics in Karachi, Pakistan. Participants were interviewed about symptoms and health care utilization during the 5 days after enrollment. Group assignment was concealed from participants, field staff, and the statistician. Primary analysis occurred from August to September 2015.
Interventions


Participants were randomly assigned (1:1) to receive BSS or placebo for 48 hours or less.
Main Outcomes and Measures


Use of systemic antibiotics within 5 days of enrollment. Secondary outcomes included measures of duration and severity of illness.
Results


Among eligible patients, 39 declined to participate, 440 enrolled, and 1 enrolled participant was lost to follow-up, for a total of 439 patients included in the analysis. Median (interquartile range) participant age was 32 (23-45) years and 187 (43%) were male. Two hundred twenty patients were randomized to BSS and 220 were randomized to placebo. Overall, 54 participants (12%) used systemic antibiotics (16% in the placebo group and 9% in the BSS group); all antibiotic use followed consultation with a physician. Use of any antibiotic was significantly lower in the BSS group (20 of 220 vs 34 of 219 patients; odds ratio [OR], 0.54; 95% CI, 0.30-0.98), as was use of fluoroquinolones (8 of 220 vs 20 of 219 patients; OR, 0.38; 95% CI, 0.16-0.88). Rates of care seeking and hospitalization were similar between groups and no difference was detected in timing of diarrhea resolution. However, those in the BSS group less commonly received intravenous rehydration (14 of 220 vs 27 of 219 patients; OR, 0.48; 95% CI, 0.25-0.95) and missed less work (median [interquartile range], 0 [0-1] vs 1 [0-1] day; P = .04) during follow-up.
Conclusions and Relevance


This study found less antibiotic use among participants given BSS for acute diarrhea in a setting where antibiotics are commonly used to treat diarrhea. Encouraging health care professionals in such settings to recommend BSS as frontline treatment for adults with diarrhea, and promoting BSS for diarrhea self-management, may reduce antibiotic use and rates of antibiotic resistance globally.
Trial Registration


ClinicalTrials.gov identifier: NCT02047162.",2019,"Use of any antibiotic was significantly lower in the BSS group (20 of 220 vs 34 of 219 patients; odds ratio [OR], 0.54; 95% CI, 0.30-0.98), as was use of fluoroquinolones (8 of 220 vs 20 of 219 patients; OR, 0.38; 95% CI, 0.16-0.88).","['Adult Outpatients With Diarrhea in Pakistan', 'Median (interquartile range) participant age was 32 (23-45) years and 187 (43%) were male', 'participants given BSS for acute diarrhea', 'adults with diarrhea', 'eligible patients, 39 declined to participate, 440 enrolled, and 1 enrolled participant was lost to follow-up, for a total of 439 patients included in the analysis', 'Two hundred twenty patients', 'Participants were patients aged 15 to 65 years with acute, nonbloody diarrhea from 22 outpatient clinics in Karachi, Pakistan', 'adult outpatients with diarrhea given bismuth subsalicylate (BSS) or placebo']","['BSS or placebo', 'placebo', 'Bismuth Subsalicylate vs Placebo']","['Measures\n\n\nUse of systemic antibiotics', 'diarrhea resolution', 'Rates of care seeking and hospitalization', 'systemic antibiotics', 'measures of duration and severity of illness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517777', 'cui_str': '440 (qualifier value)'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0053792', 'cui_str': 'bismuth subsalicylate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0053792', 'cui_str': 'bismuth subsalicylate'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}]",440.0,0.396332,"Use of any antibiotic was significantly lower in the BSS group (20 of 220 vs 34 of 219 patients; odds ratio [OR], 0.54; 95% CI, 0.30-0.98), as was use of fluoroquinolones (8 of 220 vs 20 of 219 patients; OR, 0.38; 95% CI, 0.16-0.88).","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bowen', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Mubina', 'Initials': 'M', 'LastName': 'Agboatwalla', 'Affiliation': 'Health-Oriented Preventive Education, Karachi, Pakistan.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Pitz', 'Affiliation': 'Procter & Gamble Health Care, Cincinnati, Ohio.'}, {'ForeName': 'Sadaf', 'Initials': 'S', 'LastName': 'Salahuddin', 'Affiliation': 'Health-Oriented Preventive Education, Karachi, Pakistan.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Brum', 'Affiliation': 'Procter & Gamble Health Care, Cincinnati, Ohio.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Plikaytis', 'Affiliation': 'BioStat Consulting, LLC, Jasper, Georgia.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.9441']
1872,31496260,Intracameral bevacizumab role in trabeculectomy: A 1-year prospective randomized controlled study.,"PURPOSE


To evaluate the effect of intracameral Bevacizumab on trabeculectomy success rates.
METHODS


A prospective, randomized, interventional clinical trial. Patients with primary open-angle glaucoma were randomly assigned to two groups: trabeculectomy with mitomycin C and trabeculectomy with mitomycin C and intracameral bevacizumab. Complete success is defined as an intraocular pressure (IOP) reduction of at least 30% from baseline IOP to a measured pressure of between 5 and 18 mm Hg without the use of IOP lowering medications. Qualified success is defined as same achievement of reduced IOP, but with the use of IOP lowering medications. Overall success is defined as same achievement of reduced IOP with or without the use of IOP lowering medications.
RESULTS


Thirty-three patients in the mitomycin C group and 36 patients in the mitomycin C and bevacizumab group were included in final analyses. The IOP at presentation was 28.3 ± 8 and 28.4 ± 8.6 mm Hg, compared to 10.8 ± 3.4 and 12.3 ± 3.7 mm Hg at 12 months (p < 0.0001) for the mitomycin C group and the mitomycin C and bevacizumab group, respectively. Complete success at 12 months was achieved in 65% of the mitomycin C group compared to 60% of the mitomycin C and bevacizumab group (p = 0.77). Overall success was achieved in 82% compared to 80% of patients at 12 months (p = 0.78). Both groups showed a statistically significant reduction in IOP after 6 and 12 months (p ⩽ 0.001). There were no statistically significant differences in visual acuity and complications.
CONCLUSION


Intracameral bevacizumab during mitomycin C trabeculectomy in patients with primary open-angle glaucoma apparently does not improve success rates. The adjuvant use of intracameral bevacizumab is therefore not justified.",2019,Overall success was achieved in 82% compared to 80% of patients at 12 months (p = 0.78).,"['Patients with primary open-angle glaucoma', 'patients with primary open-angle glaucoma']","['Intracameral bevacizumab', 'mitomycin C', 'intracameral Bevacizumab', 'trabeculectomy with mitomycin C and trabeculectomy with mitomycin C and intracameral bevacizumab', 'mitomycin C trabeculectomy', 'mitomycin C and bevacizumab', 'intracameral bevacizumab', 'trabeculectomy']","['success rates', 'visual acuity and complications', 'intraocular pressure (IOP) reduction', 'Complete success', 'Overall success', 'IOP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0339573', 'cui_str': 'Chronic Primary Open Angle Glaucoma'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C3263686', 'cui_str': 'Ocular trabeculectomy'}]","[{'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",33.0,0.265729,Overall success was achieved in 82% compared to 80% of patients at 12 months (p = 0.78).,"[{'ForeName': 'Gilad', 'Initials': 'G', 'LastName': 'Rabina', 'Affiliation': 'Department of Ophthalmology, Tel Aviv Sourasky Medical Center, Affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Barequet', 'Affiliation': 'Department of Ophthalmology, Tel Aviv Sourasky Medical Center, Affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mimouni', 'Affiliation': 'Department of Ophthalmology, Rambam Health Care Campus, Affiliated to the Bruce and Ruth Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Shimon', 'Initials': 'S', 'LastName': 'Kurtz', 'Affiliation': 'Department of Ophthalmology, Tel Aviv Sourasky Medical Center, Affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Gabi', 'Initials': 'G', 'LastName': 'Shemesh', 'Affiliation': 'Department of Ophthalmology, Tel Aviv Sourasky Medical Center, Affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Rosenblatt', 'Affiliation': 'Department of Ophthalmology, Tel Aviv Sourasky Medical Center, Affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Eldar', 'Initials': 'E', 'LastName': 'Rosenfeld', 'Affiliation': 'Department of Ophthalmology, Tel Aviv Sourasky Medical Center, Affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}]",European journal of ophthalmology,['10.1177/1120672119874682']
1873,31103580,Randomized Trial Comparing Transdermal With Sublingual Nitroglycerin Administration for Coronary Vasodilation in CTA.,,2019,,['Coronary Vasodilation in CTA'],['Sublingual Nitroglycerin'],[],"[{'cui': 'C0042401', 'cui_str': 'Vasorelaxation'}]","[{'cui': 'C4521982', 'cui_str': 'Sublingual'}, {'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}]",[],,0.0446488,,"[{'ForeName': 'Jan-Erik', 'Initials': 'JE', 'LastName': 'Scholtz', 'Affiliation': ''}, {'ForeName': 'Vinit', 'Initials': 'V', 'LastName': 'Baliyan', 'Affiliation': ''}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Hedgire', 'Affiliation': ''}, {'ForeName': 'Nathaniel D', 'Initials': 'ND', 'LastName': 'Mercaldo', 'Affiliation': ''}, {'ForeName': 'Theodore T', 'Initials': 'TT', 'LastName': 'Pierce', 'Affiliation': ''}, {'ForeName': 'Gabriela Zagarodne S', 'Initials': 'GZS', 'LastName': 'Missine', 'Affiliation': ''}, {'ForeName': 'Nandini M', 'Initials': 'NM', 'LastName': 'Meyersohn', 'Affiliation': ''}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Stockton', 'Affiliation': ''}, {'ForeName': 'Travis L', 'Initials': 'TL', 'LastName': 'Redel', 'Affiliation': ''}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'McNulty', 'Affiliation': ''}, {'ForeName': 'Cristy', 'Initials': 'C', 'LastName': 'Savage', 'Affiliation': ''}, {'ForeName': 'Russel J', 'Initials': 'RJ', 'LastName': 'Roberts', 'Affiliation': ''}, {'ForeName': 'Borek', 'Initials': 'B', 'LastName': 'Foldyna', 'Affiliation': ''}, {'ForeName': 'Richard A P', 'Initials': 'RAP', 'LastName': 'Takx', 'Affiliation': ''}, {'ForeName': 'Sahani', 'Initials': 'S', 'LastName': 'Dushyant', 'Affiliation': ''}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Hoffmann', 'Affiliation': ''}, {'ForeName': 'Brian B', 'Initials': 'BB', 'LastName': 'Ghoshhajra', 'Affiliation': ''}]",JACC. Cardiovascular imaging,['10.1016/j.jcmg.2019.02.027']
1874,32433790,Narrowband imaging with near-focus magnification for discriminating the gastric tumor margin before endoscopic resection: A prospective randomized multicenter trial.,"BACKGROUND AND AIM


This study investigated the usefulness of near-focus narrowband imaging (NF-NBI) for determining gastric tumor margins compared with indigo carmine chromoendoscopy (ICC) before endoscopic submucosal dissection (ESD).
METHODS


This prospective randomized controlled trial was conducted at seven teaching hospitals in Korea. Patients with gastric adenoma or differentiated adenocarcinoma undergoing ESD were enrolled and randomly assigned to the NF-NBI or ICC group. A marking dot was placed on the most proximal margin of the tumor before ESD. The primary endpoint was delineation accuracy, which was defined as presence of marking dots within 1 mm of the tumor margin under microscopic observation.
RESULTS


A total of 200 patients in the NF-NBI group and 195 patients in the ICC group were included. The delineation accuracy rate was 84.5% in the NF-NBI group and 81.0% in the ICC group (P = 0.44). However, the distance from the marking dot to the margin of the tumor was significantly shorter in the NF-NBI group than in the ICC group (0.8 ± 0.8 vs 1.2 ± 1.3 mm, P < 0.01). Even after adjustment of other clinicopathological factors that are associated with difficulty of tumor delineation, NF-NBI did not show significant association with accurate delineation (odds ratio of 0.86, P = 0.60).
CONCLUSIONS


This prospective multicenter study showed that NF-NBI is not superior to ICC in terms of accurately delineating gastric tumors (NCT02661945).",2020,This prospective multicenter study showed that NF-NBI is not superior to ICC in terms of accurately delineating gastric tumors (NCT02661945).,"['seven teaching hospitals in Korea', 'Patients with gastric adenoma or differentiated adenocarcinoma undergoing ESD', '200 patients in the NF-NBI group and 195 patients in the ICC group were included']","['indigo carmine chromoendoscopy (ICC', 'NF-NBI or ICC', 'Narrow-band imaging with near-focus magnification', 'NF-NBI', 'ICC', 'near-focus narrow-band imaging (NF-NBI', 'endoscopic resection']","['delineation accuracy', 'delineation accuracy rate']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149826', 'cui_str': 'Gastric adenoma'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C3494253', 'cui_str': 'Narrowband Imaging'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0021219', 'cui_str': 'indigo carmine'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0021219', 'cui_str': 'indigo carmine'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C3494253', 'cui_str': 'Narrowband Imaging'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}]",200.0,0.0637564,This prospective multicenter study showed that NF-NBI is not superior to ICC in terms of accurately delineating gastric tumors (NCT02661945).,"[{'ForeName': 'Jung-Wook', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Yunho', 'Initials': 'Y', 'LastName': 'Jung', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Soon Chun Hyang University College of Medicine, Cheonan, Korea.'}, {'ForeName': 'Jae-Young', 'Initials': 'JY', 'LastName': 'Jang', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Gwang Ha', 'Initials': 'GH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Pusan National University School of Medicine, and Biomedical Research Institute, Pusan National University Hospital, Busan, Korea.'}, {'ForeName': 'Byoung Wook', 'Initials': 'BW', 'LastName': 'Bang', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Inha University Hospital, Inha University School of Medicine, Incheon, Korea.'}, {'ForeName': 'Jun Chul', 'Initials': 'JC', 'LastName': 'Park', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyuk Soon', 'Initials': 'HS', 'LastName': 'Choi', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Institute of Gastrointestinal Medical Instrument Research, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jun-Hyung', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': 'Digestive Disease Center, Soonchunhyang University Hospital, Seoul, Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15109']
1875,31602689,Reducing the Biological and Psychological Toxicity of Poverty-related Stress: Initial Efficacy of the BaSICS Intervention for Early Adolescents.,"This proof-of-concept study tests the initial efficacy of the Building a Strong Identity and Coping Skills (BaSICS) intervention, a selective prevention of internalizing problems program for early adolescents exposed to high levels of poverty-related stress. Eighty-four early adolescents (M age   = 11.36 years) residing in very low-income neighborhoods were randomized to receive the 16-session intervention (n = 44) or to an assessment-only control condition (n = 40). BaSICS teaches coping skills, social identity development, and collective social action to empower youth with the ability to connect with members of their communities and cope with poverty-related stress in positive and collaborative ways. Pretest-posttest analyses showed that intervention adolescents acquired problem-solving and cognitive-restructuring skills and reduced their reliance on avoidant coping. In addition, HPA reactivity was significantly reduced in the intervention youth, but not controls. Finally, intervention youth's internalizing and somatic symptoms as reported by both youth and their parents, showed significant reductions over time, whereas control youth had no such changes. Results provide strong support for this approach to strength-building and symptom reduction in a population of early adolescents exposed to poverty-related stress.",2020,Pretest-posttest analyses showed that intervention adolescents acquired problem-solving and cognitive-restructuring skills and reduced their reliance on avoidant coping.,"['Early Adolescents', '11.36\xa0years) residing in very low-income neighborhoods', 'early adolescents exposed to high levels of poverty-related stress', 'Eighty-four early adolescents (M age  \xa0']","['Building a Strong Identity and Coping Skills (BaSICS) intervention', '16-session intervention (n\xa0=\xa044) or to an assessment-only control condition', 'BaSICS Intervention']","['HPA reactivity', 'problem-solving and cognitive-restructuring skills and reduced their reliance on avoidant coping']","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0032854', 'cui_str': 'Poverty'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4319623', 'cui_str': '84 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0966198', 'cui_str': ""P(1)-(6-hydroxymethylpterin)-P(4)-(5'-adenosyl)tetraphosphate""}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0150173', 'cui_str': 'Cognitive restructuring (regime/therapy)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",84.0,0.0212825,Pretest-posttest analyses showed that intervention adolescents acquired problem-solving and cognitive-restructuring skills and reduced their reliance on avoidant coping.,"[{'ForeName': 'Martha E', 'Initials': 'ME', 'LastName': 'Wadsworth', 'Affiliation': 'The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'McDonald', 'Affiliation': 'The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Celina M', 'Initials': 'CM', 'LastName': 'Joos', 'Affiliation': 'The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Jarl A', 'Initials': 'JA', 'LastName': 'Ahlkvist', 'Affiliation': 'The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Sarah E D', 'Initials': 'SED', 'LastName': 'Perzow', 'Affiliation': 'University of Denver, Denver, CO, USA.'}, {'ForeName': 'Emile M', 'Initials': 'EM', 'LastName': 'Tilghman-Osborne', 'Affiliation': 'The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Creavey', 'Affiliation': 'The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Gina M', 'Initials': 'GM', 'LastName': 'Brelsford', 'Affiliation': 'Penn State University Harrisburg, Middletown, PA, USA.'}]",American journal of community psychology,['10.1002/ajcp.12400']
1876,31799694,Are Lactobacillus salivarius G60 and inulin more efficacious to treat patients with oral halitosis and tongue coating than the probiotic alone and placebo? A randomized clinical trial.,"BACKGROUND


The combination of probiotics and prebiotics might be useful to treat oral halitosis. The aim of this study was to assess the effect of Lactobacillus salivarius G60 (LS) and inulin on oral halitosis and tongue coating.
METHODS


In this double-masked, randomized, phase II clinical trial, 45 patients (aged 35 ± 15 years, 66% female) with oral halitosis and tongue coating were allocated to three treatment groups (n = 15) using gums of oral dissolution (one gum every 12 hours) for 10 days. Each gum contained LS (1 billion colony forming units [CFUs]) + inulin (1 g), LS (1 billion CFU) or placebo. Primary outcomes were organoleptic test, Halimeter, and tongue coating, whereas secondary outcomes were quality of life (QOL) and treatment safety. Generalized linear models were used, adjusting for age and sex. In vitro tests were performed to verify whether LS interacts with inulin and whether LS inhibits the growth of Porphyromonas gingivalis and Prevotella intermedia.
RESULTS


Forty-four patients (97%) completed the study. Patients treated with LS + inulin showed greater reduction in halitosis measured by Halimeter compared with placebo (adjusted post-intervention average: 96.7 versus 142.5 ppb; P = 0.003), whereas LS and placebo did not differ (115.7 versus 142.5 ppb; P = 0.097). Organoleptic measurements and coating index showed a similar decrease for all groups. QOL improved in patients treated with LS + inulin compared with placebo (P = 0.029). Side effects were mild and transient in all groups. LS did not metabolize inulin but inhibited the growth of P. gingivalis and P. intermedia after 72 hours.
CONCLUSIONS


Treatment with L. salivarius G60 combined or not with inulin showed significant decrease in the outcomes organoleptic test, Halimeter, and coating index, improving oral halitosis. However, no significant difference was obtained between the groups.",2020,Quality of life improved in patients treated with LS+inulin compared to placebo (p = 0.029).,"['Forty-four patients (97%) completed the study', '45 patients (35 ± 15 years old, 66% female) with oral halitosis and tongue coating']","['placebo', 'Lactobacillus salivarius G60 (LS) and inulin', 'gums of oral dissolution', 'LS+inulin']","['organoleptic test, Halimeter and tongue coating', 'quality of life and treatment safety', 'Organoleptic measurements and coating index', 'reduction in halitosis', 'Quality of life', 'outcomes organoleptic test, Halimeter and coating index, improving oral halitosis', 'Side effects']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0018520', 'cui_str': 'Halitosis'}, {'cui': 'C0040408', 'cui_str': 'Tongue'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0317593', 'cui_str': 'Lactobacillus salivarius'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C1378701', 'cui_str': 'Gum (basic dose form)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0040408', 'cui_str': 'Tongue'}, {'cui': 'C0034380'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0018520', 'cui_str': 'Halitosis'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",44.0,0.197802,Quality of life improved in patients treated with LS+inulin compared to placebo (p = 0.029).,"[{'ForeName': 'Camila Rafaela', 'Initials': 'CR', 'LastName': 'Mousquer', 'Affiliation': 'Post Graduate Program in Dentistry, Dental School, University of Passo Fundo, Passo Fundo, Brazil.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Della Bona', 'Affiliation': 'Post Graduate Program in Dentistry, Dental School, University of Passo Fundo, Passo Fundo, Brazil.'}, {'ForeName': 'Daiane Cristina', 'Initials': 'DC', 'LastName': 'Milani', 'Affiliation': 'Post Graduate Program in Dentistry, Dental School, University of Passo Fundo, Passo Fundo, Brazil.'}, {'ForeName': 'Sidia Maria', 'Initials': 'SM', 'LastName': 'Callegari-Jacques', 'Affiliation': 'Department of Statistics, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Microbiology, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Marcia Pinto Alves', 'Initials': 'MPA', 'LastName': 'Mayer', 'Affiliation': 'Department of Microbiology, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Cassiano Kuchenbecker', 'Initials': 'CK', 'LastName': 'Rösing', 'Affiliation': 'Post Graduate Program in Dentistry, Dental School, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Fornari', 'Affiliation': 'Post Graduate Program in Dentistry, Dental School, University of Passo Fundo, Passo Fundo, Brazil.'}]",Journal of periodontology,['10.1002/JPER.19-0089']
1877,31490257,"Intravenous Lidocaine for the Prevention of Postoperative Catheter-Related Bladder Discomfort in Male Patients Undergoing Transurethral Resection of Bladder Tumors: A Randomized, Double-Blind, Controlled Trial.","BACKGROUND


Male patients undergoing transurethral resection of bladder tumors (TURBT) are prone to suffer from catheter-related bladder discomfort (CRBD). Lidocaine administration has been widely performed to reduce postoperative pain. Here, the effect of intravenous lidocaine administration on moderate-to-severe CRBD was evaluated in male patients undergoing TURBT.
METHODS


Patients were randomly allocated to receive intravenous lidocaine (1.5 mg/kg bolus dose followed by a 2 mg/kg/h continuous infusion during the intraoperative period, which was continued for 1 hour postsurgery; group L) or placebo (normal saline; group C). The primary outcome was moderate-to-severe CRBD at 0 hour postsurgery (on admission to the postanesthetic care unit), analyzed using the χ test. The secondary outcome was opioid requirement during the 24-hour postoperative period. None, mild, and moderate-to-severe CRBD at 1, 2, and 6 hours postsurgery, postoperative pain, patient satisfaction, side effects of lidocaine and rescue medications (tramadol and fentanyl), and surgical complications were also assessed.
RESULTS


A total of 132 patients were included in the study (66 patients in each group). The incidence of moderate-to-severe CRBD at 0 hour postsurgery was significantly lower in group L than in group C (25.8% vs 66.7%, P < .001, relative risk: 0.386, 95% confidence interval: 0.248-0.602). Opioid requirements during the 24-hour postoperative period were significantly lower in group L than in group C (10.0 mg [interquartile range (IQR), 5.0-15.0 mg] vs 13.8 mg [IQR, 10.0-20.0 mg], P = .005). At 1 and 2 hours postsurgery (but not at 6 hours), the incidence of moderate-to-severe CRBD was significantly lower in group L than in group C (1 hour: 10.6% vs 27.3%, P = .026; 2 hours: 0.0% vs 15.2%, P = .003). Patient satisfaction was significantly greater in group L than in group C (5.0 [IQR, 4.8-6.0] vs 4.0 [IQR, 4.0-5.0], P < .001). No lidocaine-related side effects were reported. Rescue medication-related side effects and surgical complications did not differ significantly between the 2 groups.
CONCLUSIONS


Intravenous lidocaine administration resulted in lower incidence of moderate-to-severe CRBD, lower opioid requirement, and higher patient satisfaction in male patients undergoing TURBT without evidence of significant side effects.",2020,"Patient satisfaction was signi&filig;cantly greater in group L than in group C (5.0 [IQR, 4.8-6.0] vs 4.0 [IQR, 4.0-5.0], P < .001).","['Patients', 'male patients undergoing TURBT', 'Male Patients Undergoing Transurethral Resection of Bladder Tumors', '132 patients were included in the study (66 patients in each group', 'male patients undergoing', 'Male patients undergoing']","['lidocaine', 'transurethral resection of bladder tumors (TURBT', 'placebo (normal saline', 'TURBT', 'intravenous lidocaine', 'Lidocaine', 'Intravenous Lidocaine']","['postoperative pain', 'postoperative pain, patient satisfaction, side effects of lidocaine and rescue medications (tramadol and fentanyl), and surgical complications', 'side effects', 'incidence of moderate-to-severe CRBD', 'Patient satisfaction', 'moderate-to-severe CRBD', 'Opioid requirements', 'opioid requirement during the 24-hour postoperative period', 'Rescue medication-related side effects and surgical complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0401496', 'cui_str': 'Transurethral resection of bladder neoplasm'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0401496', 'cui_str': 'Transurethral resection of bladder neoplasm'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",132.0,0.45349,"Patient satisfaction was signi&filig;cantly greater in group L than in group C (5.0 [IQR, 4.8-6.0] vs 4.0 [IQR, 4.0-5.0], P < .001).","[{'ForeName': 'Doo-Hwan', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jun-Young', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jihion', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sang-A', 'Initials': 'SA', 'LastName': 'Lee', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sooin', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jai-Hyun', 'Initials': 'JH', 'LastName': 'Hwang', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Gi-Ho', 'Initials': 'GH', 'LastName': 'Koh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chosun University Hospital, Gwangju, Republic of Korea.'}, {'ForeName': 'Young-Kug', 'Initials': 'YK', 'LastName': 'Kim', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004405']
1878,31841995,Impact of Severity of Chronic Kidney Disease on Management and Outcomes Following Transcatheter Aortic Valve Replacement With Newer-Generation Transcatheter Valves.,"BACKGROUND


The association between chronic kidney disease (CKD) and outcomes following transcatheter aortic valve replacement (TAVR) in the setting of newer-generation transcatheter heart valves (THVs) is not well known. Accordingly, we sought to assess the impact of CKD severity on outcomes in adults undergoing TAVR with newer-generation THVs.
METHODS


The study population included 298 consecutive patients who underwent TAVR with a newer-generation THV (Sapien 3 [Edwards Lifesciences] or CoreValve Evolut R or Evolut Pro [Medtronic]) from December 2015 to June 2018 at an academic tertiary medical center. Patients were classified into three groups: group I, defined as creatinine clearance (CrCl) ≥60 mL/ min (n = 133); group II, defined as CrCl ≥30 mL/min and <60 mL/min (n = 128); and group III, defined as CrCl <30 mL/min (n = 37).
RESULTS


Median length of stay was longer in groups II and III (2.0 days in group I vs 3.0 days in group II vs 4.0 days in group III; P<.01). While rates of 30-day readmission were significantly higher in groups II and III compared with group I (14.5% in group I vs 26.6% in group II vs 37.1% in group III; P<.01), rates of in-hospital and 30-day mortality and disabling stroke were similar. In multivariable analysis, CKD was independently associated with higher 30-day readmission rates (group II: odds ratio, 2.10; 95% confidence interval 1.02-4.32; group III: odds ratio, 3.52; 95% confidence interval, 1.40-8.87; group I: referent).
CONCLUSIONS


In this prospective study of adults undergoing TAVR with newer-generation THVs, moderate and severe CKD was associated with a nearly 2-fold and 3-fold higher risk of 30-day readmission, respectively.",2020,While rates of 30-day readmission were significantly higher in groups II and III compared with group,"['298 consecutive patients who underwent', 'adults undergoing TAVR with newer-generation THVs', 'adults undergoing TAVR with newer-generation THVs, moderate and severe CKD', 'December 2015 to June 2018 at an academic tertiary medical center']","['transcatheter aortic valve replacement (TAVR', 'Transcatheter Aortic Valve Replacement With Newer-Generation Transcatheter Valves', 'TAVR with a newer-generation THV (Sapien 3 [Edwards Lifesciences] or CoreValve Evolut R or Evolut Pro']","['Median length of stay', 'rates of in-hospital and 30-day mortality and disabling stroke', '30-day readmission rates', 'rates of 30-day readmission']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}]","[{'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach (qualifier value)'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}]",298.0,0.0221564,While rates of 30-day readmission were significantly higher in groups II and III compared with group,"[{'ForeName': 'Ely', 'Initials': 'E', 'LastName': 'Gracia', 'Affiliation': ''}, {'ForeName': 'Ting-Yu', 'Initials': 'TY', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Callahan', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bilfinger', 'Affiliation': ''}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Tannous', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pyo', 'Affiliation': ''}, {'ForeName': 'Smadar', 'Initials': 'S', 'LastName': 'Kort', 'Affiliation': ''}, {'ForeName': 'Hal', 'Initials': 'H', 'LastName': 'Skopicki', 'Affiliation': ''}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Weinstein', 'Affiliation': ''}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Montellese', 'Affiliation': ''}, {'ForeName': 'Giridhar', 'Initials': 'G', 'LastName': 'Korlipara', 'Affiliation': ''}, {'ForeName': 'Shamim', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': ''}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Chikwe', 'Affiliation': ''}, {'ForeName': 'Puja B', 'Initials': 'PB', 'LastName': 'Parikh', 'Affiliation': 'Division of Cardiology, Stony Brook University Medical Center, Health Sciences Center T16, Room 080, Stony Brook, NY 11794-8160 USA. puja.parikh@stonybrookmedicine.edu.'}]",The Journal of invasive cardiology,[]
1879,31462766,Reward related ventral striatal activity and differential response to sertraline versus placebo in depressed individuals.,"Medications to treat major depressive disorder (MDD) are not equally effective across patients. Given that neural response to rewards is altered in MDD and given that reward-related circuitry is modulated by dopamine and serotonin, we examined, for the first time, whether reward-related neural activity moderated response to sertraline, an antidepressant medication that targets these neurotransmitters. A total of 222 unmedicated adults with MDD randomized to receive sertraline (n = 110) or placebo (n = 112) in the Establishing Moderators and Biosignatures of Antidepressant Response in Clinical Care (EMBARC) study completed demographic and clinical assessments, and pretreatment functional magnetic resonance imaging while performing a reward task. We tested whether an index of reward system function in the ventral striatum (VS), a key reward circuitry region, moderated differential response to sertraline versus placebo, assessed with the Hamilton Rating Scale for Depression (HSRD) over 8 weeks. We observed a significant moderation effect of the reward index, reflecting the temporal dynamics of VS activity, on week-8 depression levels (Fs ≥ 9.67, ps ≤ 0.002). Specifically, VS responses that were abnormal with respect to predictions from reinforcement learning theory were associated with lower week-8 depression symptoms in the sertraline versus placebo arms. Thus, a more abnormal pattern of pretreatment VS dynamic response to reward expectancy (expected outcome value) and prediction error (difference between expected and actual outcome), likely reflecting serotonergic and dopaminergic deficits, was associated with better response to sertraline than placebo. Pretreatment measures of reward-related VS activity may serve as objective neural markers to advance efforts to personalize interventions by guiding individual-level choice of antidepressant treatment.",2020,"Specifically, VS responses that were abnormal with respect to predictions from reinforcement learning theory were associated with lower week-8 depression symptoms in the sertraline versus placebo arms.","['depressed individuals', '222 unmedicated adults with MDD randomized to receive']","['placebo (n\u2009=\u2009112) in the Establishing Moderators and Biosignatures of Antidepressant Response in Clinical Care (EMBARC) study completed demographic and clinical assessments, and pretreatment functional magnetic resonance imaging while performing a reward task', 'sertraline', 'placebo', 'sertraline versus placebo']","['Hamilton Rating Scale for Depression (HSRD', 'depression symptoms']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression (assessment scale)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",222.0,0.129786,"Specifically, VS responses that were abnormal with respect to predictions from reinforcement learning theory were associated with lower week-8 depression symptoms in the sertraline versus placebo arms.","[{'ForeName': 'Tsafrir', 'Initials': 'T', 'LastName': 'Greenberg', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA. greenbergt@upmc.edu.'}, {'ForeName': 'Jay C', 'Initials': 'JC', 'LastName': 'Fournier', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Richelle', 'Initials': 'R', 'LastName': 'Stiffler', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Henry W', 'Initials': 'HW', 'LastName': 'Chase', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Jorge R', 'Initials': 'JR', 'LastName': 'Almeida', 'Affiliation': 'Department of Psychiatry, Dell Medical School, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Haris', 'Initials': 'H', 'LastName': 'Aslam', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Marisa S', 'Initials': 'MS', 'LastName': 'Toups', 'Affiliation': 'Department of Psychiatry, Dell Medical School, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Carmody', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Benji', 'Initials': 'B', 'LastName': 'Kurian', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Peltier', 'Affiliation': 'Functional MRI Laboratory, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Adams', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons and The New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Melvin G', 'Initials': 'MG', 'LastName': 'McInnis', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Oquendo', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Parsey', 'Affiliation': 'Departments of Psychiatry and Behavioral Science & Radiology, Stony Brook University, Stony Brook, NY, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'McGrath', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons and The New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Myrna', 'Initials': 'M', 'LastName': 'Weissman', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons and The New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Madhukar', 'Initials': 'M', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Phillips', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}]",Molecular psychiatry,['10.1038/s41380-019-0490-5']
1880,31373036,"Significant effect of information placebo on exercise test results in children with normal weight, overweight and obesity.","AIM


The aim of the study was to examine the effect of information placebo on fitness test results in normal weight, overweight and obese children.
METHODS


Twenty-four pre-pubertal children with overweight or obesity and 24 age and maturity-matched normal weight children performed a progressive treadmill exercise test twice. Different types of information were randomly provided regarding a water drink consumed prior to testing; standard (water) vs deliberate positive (presumed energy drink, placebo) information.
RESULTS


Following the placebo drink, both groups demonstrated significantly higher peak heart rate (overweight 165.8 ± 16.7 vs 174.2 ± 14.8 bpm and normal weight 177.9 ± 13.6 vs 189.8 ± 12.2 bpm) and longer time to exhaustion (overweight 396.9 ± 161.9 vs 521.5 ± 182.5 seconds; normal weight: 700.1 ± 155.2 vs 893.3 ± 150.1 seconds). Despite longer exercise duration and higher peak heart rate, average and peak rate of perceived exertion were significantly lower after the placebo drink (overweight 14.1 ± 2.5 vs 12.5 ± 2.5; normal weight 12.1 ± 1.4 vs 10.7 ± 1.5), with significantly shorter recovery time (overweight 132.2 ± 28.5 vs 118.4 ± 31.6; normal weight: 106.7 ± 18.6 vs 96.7 ± 17.8 seconds).
CONCLUSION


Our results demonstrate a significant effect of information placebo on fitness test results that is unrelated to body weight. Children with obesity may enhance their physical activity levels and energy expenditure if properly encouraged.",2020,"Despite longer exercise duration and higher peak heart rate, average and peak rate of perceived exertion were significantly lower after the placebo drink (overweight 14.1±2.5 versus 12.5±2.5; normal weight 12.1±1.4 versus 10.7±1.5), with significantly shorter recovery time (overweight 132.2±28.5 versus 118.4±31.6; normal weight: 106.7±18.6 versos 96.7±17.8seconds).
","['children with normal weight, overweight and obesity', 'normal weight, overweight and obese children', 'Children with obesity', 'Twenty-four pre-pubertal children with overweight or obesity and 24, age and maturity-matched normal weight children']","['progressive treadmill exercise test twice', 'placebo', 'water drink consumed prior to testing; standard (water) versus deliberate positive (presumed energy drink, placebo', 'information placebo', 'placebo drink']","['peak heart rate', 'recovery time', 'longer time to exhaustion', 'peak heart rate, average and peak rate of perceived exertion']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C1628325', 'cui_str': 'Pre-pubertal'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0449989', 'cui_str': 'Maturity (attribute)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C3179078', 'cui_str': 'Energy Drinks'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}]",24.0,0.165288,"Despite longer exercise duration and higher peak heart rate, average and peak rate of perceived exertion were significantly lower after the placebo drink (overweight 14.1±2.5 versus 12.5±2.5; normal weight 12.1±1.4 versus 10.7±1.5), with significantly shorter recovery time (overweight 132.2±28.5 versus 118.4±31.6; normal weight: 106.7±18.6 versos 96.7±17.8seconds).
","[{'ForeName': 'Shira', 'Initials': 'S', 'LastName': 'Fanti-Oren', 'Affiliation': 'Cheryl Spencer Department of Nursing, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Daphna', 'Initials': 'D', 'LastName': 'Birenbaum-Carmeli', 'Affiliation': 'Cheryl Spencer Department of Nursing, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Nemet', 'Affiliation': 'Pediatric Department, Child Health and Sports Center, Meir Medical Center, Sackler School of Medicine, Tel Aviv University, Kfar-Saba, Israel.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Pantanowitz', 'Affiliation': 'Pediatric Department, Child Health and Sports Center, Meir Medical Center, Sackler School of Medicine, Tel Aviv University, Kfar-Saba, Israel.'}, {'ForeName': 'Alon', 'Initials': 'A', 'LastName': 'Eliakim', 'Affiliation': 'Pediatric Department, Child Health and Sports Center, Meir Medical Center, Sackler School of Medicine, Tel Aviv University, Kfar-Saba, Israel.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.14959']
1881,31473598,"Lack of effects of evidence-based, individualised counselling on medication use in insured patients with mild hypertension in China: a randomised controlled trial.","OBJECTIVE


To evaluate whether evidence-based, individualised (EBI) counselling regarding hypertension and the treatment would affect medication use in insured patients with mild hypertension in China.
METHODS


We conducted a parallel-group, randomised controlled trial in two primary care centres in Shenzhen, a metropolitan city in China. Patients with mild primary hypertension, 10-year risk of cardiovascular diseases (CVDs) lower than 20% and no history of CVDs were recruited and randomly allocated to two groups. EBI plus general counselling was provided to the intervention group and general counselling alone to the control group. EBI counselling included information on the 10-year CVD risk and treatment benefit in terms of absolute risk reduction estimated for each individual and information on average side effects and costs of antihypertensive drugs. The outcomes included use of antihypertensive drugs and adherence to the treatment at 6-month follow-up, with the former being primary outcome.
RESULTS


Two hundred and ten patients were recruited, with 103 and 107 allocated to the intervention and control groups, respectively. At baseline, 62.4% of the patients were taking antihypertensive drugs that were all covered by health insurance. At the end of 6-month follow-up, there was no statistically significant difference in the rate of medication use between the intervention group and the control group (65.0% vs 57.9%; OR=1.35, 95% CI: 0.77 to 2.36). The difference in adherence rate between the two groups was not statistically significant either (43.7% vs 40.2%; OR=1.15, 95% CI 0.67 to 2.00]). The results were robust in sensitivity analyses that used different cutoffs to define the two outcomes.
CONCLUSIONS


The EBI counselling by health educators other than the caring physicians had little impact on treatment choices and drug-taking behaviours in insured patients with mild primary hypertension in this study. It remains unclear whether EBI counselling would make a difference in uninsured patients, especially when conducted by the caring physicians.
TRIAL REGISTRATION NUMBER


ChiCTR-TRC-14004169.",2020,"At the end of 6-month follow-up, there was no statistically significant difference in the rate of medication use between the intervention group and the control group (65.0% vs 57.9%; OR=1.35, 95% CI: 0.77 to 2.36).","['insured patients with mild primary hypertension', 'two primary care centres in Shenzhen, a metropolitan city in China', 'insured patients with mild hypertension in China', 'Two hundred and ten patients were recruited, with 103 and 107 allocated to the intervention and control groups, respectively', 'Patients with mild primary hypertension, 10-year risk of cardiovascular diseases (CVDs) lower than 20% and no history of CVDs']","['individualised (EBI) counselling', 'individualised counselling']","['adherence rate', 'rate of medication use', '10-year CVD risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0085580', 'cui_str': 'Essential Hypertension'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0332122', 'cui_str': 'No history of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",210.0,0.163999,"At the end of 6-month follow-up, there was no statistically significant difference in the rate of medication use between the intervention group and the control group (65.0% vs 57.9%; OR=1.35, 95% CI: 0.77 to 2.36).","[{'ForeName': 'Mengyang', 'Initials': 'M', 'LastName': 'Di', 'Affiliation': 'Department of Medicine, Rhode Island Hospital, Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Mao', 'Affiliation': 'Department of Epidemiology, School of Public Health, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Zuyao', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Division of Epidemiology, School of Public Health and Primary Care, Chinese University of Hong Kong, New Territories, Hong Kong.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Ding', 'Affiliation': 'Longgang Center for Disease Control and Prevention, Shenzhen, China.'}, {'ForeName': 'Qu', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Longgang Center for Disease Control and Prevention, Shenzhen, China.'}, {'ForeName': 'Shuiming', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Longgang Center for Disease Control and Prevention, Shenzhen, China.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': ""Central City Community Healthcare Centre, Longgang People's Hospital, Shenzhen, China.""}, {'ForeName': 'Kunhua', 'Initials': 'K', 'LastName': 'Jiang', 'Affiliation': ""Ziwei Garden Community Healthcare Centre, Longgang People's Hospital, Shenzhen, China.""}, {'ForeName': 'Jinling', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Division of Epidemiology, School of Public Health and Primary Care, Chinese University of Hong Kong, New Territories, Hong Kong jltang@cuhk.edu.hk.'}]",BMJ evidence-based medicine,['10.1136/bmjebm-2019-111197']
1882,31483750,Application of an innovative high-throughput liquid chromatography-tandem mass spectrometry method for simultaneous analysis of 18 hazardous drugs to rule out accidental acute chemotherapy exposures in health care workers.,"OBJECTIVES


Despite safe handling guidelines published by several groups, health care worker exposure to hazardous drugs continues to occur due to suboptimal engineering controls and low use of protective equipment. Simple, multi-target and specific analytical methods are needed so that acute exposures to these drugs in the workplace can be assessed rapidly. Our aim was to develop an analytical method for simultaneous detection and quantification of widely used cancer drugs to rule out accidental acute chemotherapy exposures in health care workers.
METHODS


We examined the feasibility of alternate high-performance liquid chromatographic-tandem mass spectrometry methods to simultaneously detect eighteen chemotherapy analytes in plasma and urine. The linear concentration ranges tested during assay development were 0.1-50 ng/mL. After development of a multi-analyte assay protocol, plasma samples (n = 743) from a multi-center cluster-randomized clinical trial (n = 12 sites) of an hazardous drug educational intervention were assayed. Confirmatory assays were performed based on the individual acute-spill case-histories.
RESULTS


An innovative HPLC-multiple reaction monitoring-information dependent acquisition-enhanced production ion (MRM-IDA-EPI) analytical method was developed to simultaneously detect: cytarabine, gemcitabine, dacarbazine, methotrexate, topotecan, mitomycin, pemetrexed, irinotecan, doxorubicin, vincristine, vinblastine, ifosamide, cyclophosphamide, vinorelbine, bendamustine, etoposide, docetaxel, and paclitaxel. The retention times ranged from 4 min to 13 min for the analytical run. The limit of detection (MRM-IDA-EPI) and limit of quantitation (MRM) was 0.25 ng/mL and 0.1 ng/mL, respectively for most analytes. No detectable plasma concentrations were measured at baseline, post-intervention and in cases of documented acute spills. Use of a secondary tandem mass spectrometry approach was able to successfully rule out false positive results.
CONCLUSIONS


Development of a sensitive high-throughput multi-analyte cancer chemotherapy assay is feasible using an MRM-IDA-EPI method. This method can be used to rapidly rule out systemic exposure to accidental acute chemotherapy spills in health care workers.",2020,"No detectable plasma concentrations were measured at baseline, post-intervention and in cases of documented acute spills.","['18 hazardous drugs to rule out accidental acute chemotherapy exposures in health care workers', 'accidental acute chemotherapy spills in health care workers']","['innovative high-throughput liquid chromatography-tandem mass spectrometry method', 'hazardous drug educational intervention', 'cytarabine, gemcitabine, dacarbazine, methotrexate, topotecan, mitomycin, pemetrexed, irinotecan, doxorubicin, vincristine, vinblastine, ifosamide, cyclophosphamide, vinorelbine, bendamustine, etoposide, docetaxel, and paclitaxel']","['limit of detection (MRM-IDA-EPI) and limit of quantitation (MRM', 'detectable plasma concentrations']","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0521129', 'cui_str': 'Accidental (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0008565', 'cui_str': 'Liquid Chromatography'}, {'cui': 'C0599748', 'cui_str': 'Mass Spectrometry-Mass Spectrometry'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0146224', 'cui_str': 'Topotecan'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0042670', 'cui_str': 'Vinblastine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C2718050', 'cui_str': 'Limit of Detection'}, {'cui': 'C0267963', 'cui_str': 'Pancreatic Insufficiency'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",743.0,0.0773291,"No detectable plasma concentrations were measured at baseline, post-intervention and in cases of documented acute spills.","[{'ForeName': 'Pan', 'Initials': 'P', 'LastName': 'Shu', 'Affiliation': 'Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Zhao', 'Affiliation': 'Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Wen', 'Affiliation': 'Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Mendelsohn-Victor', 'Affiliation': 'School of Nursing, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Duxin', 'Initials': 'D', 'LastName': 'Sun', 'Affiliation': 'Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Friese', 'Affiliation': 'School of Nursing, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Manjunath P', 'Initials': 'MP', 'LastName': 'Pai', 'Affiliation': 'Department of Clinical Pharmacy, College of Pharmacy, University of Michigan, Ann Arbor, MI, USA.'}]",Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners,['10.1177/1078155219870591']
1883,31470877,Impact of game mode in multi-user serious games for upper limb rehabilitation: a within-person randomized trial on engagement and social involvement.,"BACKGROUND


Serious games have been increasingly used for motor rehabilitation. However, it is not well known how different game features can be used to impact specific skills properly. Here, we study how the mode (competitive, co-active, collaborative) in which a multi-user game is presented impacts engagement and social involvement.
METHODS


We collected data from 20 pairs of community-dwelling older adults (71.5 ± 8.7 years) in a study following a within-persons design. The participants performed a two-player upper limb rehabilitation game with three conditions (Competitive, Co-active, and Collaborative modes). Engagement and social involvement were assessed through the Core Module and Social Presence Module, respectively, from the Game Experience Questionnaire. To infer the impact of personality and cognitive function, users answered the International Personality Item Pool (short version) and the Montreal Cognitive Assessment, respectively.
RESULTS


Results show that the Collaborative game mode promotes more social involvement when compared to Competitive and Co-active modes. This result is mostly explained by those participants with higher cognitive skills, and those that are more extrovert. Extrovert participants feel more empathy and are behaviorally more involved when playing the Collaborative mode. Also, the Collaborative mode is shown to be appropriate to promote interaction with participants that previously had a distant relationship, while the Competitive mode seems to be more beneficial to promote empathy between players with a closer relationship.
CONCLUSIONS


The Collaborative game mode elicited significantly higher social involvement in terms of Empathy, Positive Affect, and Behavioral Involvement. Hence, this game mode seems to be the most adequate choice to be used in multiplayer rehabilitation settings, where social interaction is intended.",2019,"The Collaborative game mode elicited significantly higher social involvement in terms of Empathy, Positive Affect, and Behavioral Involvement.","['We collected data from 20 pairs of community-dwelling older adults (71.5\u2009±\u20098.7\u2009years) in a study following a within-persons design', 'upper limb rehabilitation']","['player upper limb rehabilitation game with three conditions (Competitive, Co-active, and Collaborative modes']",['social involvement'],"[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517880', 'cui_str': '8.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}]",,0.0504897,"The Collaborative game mode elicited significantly higher social involvement in terms of Empathy, Positive Affect, and Behavioral Involvement.","[{'ForeName': 'Fábio', 'Initials': 'F', 'LastName': 'Pereira', 'Affiliation': 'Faculdade de Ciências Exatas e da Engenharia, Universidade da Madeira, Campus Universitário da Penteada, 9020-105, Funchal, Portugal. fabiodinis.pereira@m-iti.org.'}, {'ForeName': 'Sergi', 'Initials': 'S', 'LastName': 'Bermúdez I Badia', 'Affiliation': 'Faculdade de Ciências Exatas e da Engenharia, Universidade da Madeira, Campus Universitário da Penteada, 9020-105, Funchal, Portugal.'}, {'ForeName': 'Rúben', 'Initials': 'R', 'LastName': 'Ornelas', 'Affiliation': 'ITI-LARSyS and Madeira ITI, Pólo Científico e Tecnológico da Madeira, Caminho da Penteada, 9020-105, Funchal, Portugal.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'S Cameirão', 'Affiliation': 'Faculdade de Ciências Exatas e da Engenharia, Universidade da Madeira, Campus Universitário da Penteada, 9020-105, Funchal, Portugal.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-019-0578-9']
1884,31849453,The Effect of Glutamine Supplementation on Oxidative Stress and Matrix Metalloproteinase 2 and 9 After Exhaustive Exercise.,"Background


Glutamine is the most abundant amino acid in plasma and skeletal muscles and an important fuel for immune system cells. It has beneficial anti-inflammatory and antioxidant properties which may be considered as a potentially useful supplement for athletes. The present study was conducted to investigate the effect of glutamine supplementation on oxidative stress and matrix metalloproteinase 2 and 9 after exhaustive exercise in young healthy males.
Materials and methods


In this study, 30 healthy males (supplement =15 and control=15) were randomly assigned into two groups. The supplement group received 0.3 g/kg BW of glutamine along with 25 gr of sugar dissolved in 250 cc water per day. The control group received 25 gr of sugar in 250 cc water per day. Fasting blood samples were taken at baseline and at the end of 14 days of intervention. The participants underwent exercise until experiencing full-body exhaustive fatigue for 16 ± 2.84 mins, and then fasting blood samples were taken. Serum levels of TAC, MDA, MMP2, MMP9, glutathione, and hs-CRP were measured.
Results


Serum levels of MDA and hs-CRP significantly decreased in the supplement group (p< 0.05). The serum level of TAC significantly increased in the supplement group (p< 0.05). Glutathione serum levels significantly increased after exhaustive exercise (p< 0.05). Serum levels of MMP2 and MMP9 remained unchanged.
Conclusion


Results of this study showed that, some biochemical factors are time-dependent and can increase or decrease over time, as well as, serum levels of hs-CRP and MDA decreased with glutamine supplementation along with the increase in the TAC serum levels, but this supplementation had no effect on serum levels of MMP2 and MMP9 in exhaustive exercise.",2019,Serum levels of MDA and hs-CRP significantly decreased in the supplement group (p< 0.05).,"['young healthy males', '30 healthy males (supplement =15 and control=15']","['glutamine supplementation', 'Glutamine Supplementation', 'glutamine']","['Fasting blood samples', 'Glutathione serum levels', 'Serum levels of MMP2 and MMP9', 'Serum levels of TAC, MDA, MMP2, MMP9, glutathione, and hs-CRP', 'serum levels of MMP2 and MMP9', 'serum levels of hs-CRP and MDA', 'Oxidative Stress and Matrix Metalloproteinase', 'TAC serum levels', 'serum level of TAC', 'Serum levels of MDA and hs-CRP']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0017797', 'cui_str': 'Glutamine'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0623362', 'cui_str': 'MMPs'}]",30.0,0.0478638,Serum levels of MDA and hs-CRP significantly decreased in the supplement group (p< 0.05).,"[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Nemati', 'Affiliation': 'Ardabil University of Medical Sciences, School of Medicine, Department of Clinical Biochemistry, Ardabil, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Alipanah-Moghadam', 'Affiliation': 'Ardabil University of Medical Sciences, School of Medicine, Department of Clinical Biochemistry, Ardabil, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Molazadeh', 'Affiliation': 'Ardabil University of Medical Sciences, School of Medicine, Department of Clinical Biochemistry, Ardabil, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Naghizadeh Baghi', 'Affiliation': 'University of Mohaghegh Ardabili, Department of Exercise and Physiology, Ardabil, Iran.'}]","Drug design, development and therapy",['10.2147/DDDT.S218606']
1885,31473295,Minoxidil 1 mg oral versus minoxidil 5% topical solution for the treatment of female-pattern hair loss: A randomized clinical trial.,,2020,,['Female Pattern Hair Loss'],['Minoxidil'],[],"[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}]","[{'cui': 'C0026196', 'cui_str': 'Minoxidil'}]",[],,0.0587897,,"[{'ForeName': 'Paulo Müller', 'Initials': 'PM', 'LastName': 'Ramos', 'Affiliation': 'Departamento de Dermatologia e Radioterapia, Universidade Estadual Paulista - UNESP, Botucatu, São Paulo, Brazil. Electronic address: dermato.paulo@gmail.com.'}, {'ForeName': 'Rodney D', 'Initials': 'RD', 'LastName': 'Sinclair', 'Affiliation': 'Department of Medicine, University of Melbourne, Parkville, Australia; Sinclair Dermatology, Melbourne, Australia.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kasprzak', 'Affiliation': 'TrichoLAB, Bad Birmbach, Germany.'}, {'ForeName': 'Hélio Amante', 'Initials': 'HA', 'LastName': 'Miot', 'Affiliation': 'Departamento de Dermatologia e Radioterapia, Universidade Estadual Paulista - UNESP, Botucatu, São Paulo, Brazil.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.08.060']
1886,31430226,"Pyrotinib or Lapatinib Combined With Capecitabine in HER2-Positive Metastatic Breast Cancer With Prior Taxanes, Anthracyclines, and/or Trastuzumab: A Randomized, Phase II Study.","PURPOSE


Pyrotinib, an irreversible pan-ErbB inhibitor, showed promising antitumor activity and acceptable tolerability in a phase I trial. We assessed the efficacy and tolerability of pyrotinib versus lapatinib, both in combination with capecitabine, in women with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer in an open-label, multicenter, randomized phase II study.
PATIENTS AND METHODS


Chinese patients with HER2-positive relapsed or metastatic breast cancer previously treated with taxanes, anthracyclines, and/or trastuzumab were assigned (1:1) to receive 400 mg pyrotinib or lapatinib 1,250 mg orally once per day for 21-day cycles in combination with capecitabine (1,000 mg/m 2  orally twice per day on days 1 to 14). The primary end point was investigator-assessed overall response rate per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
RESULTS


Between May 29, 2015, and March 15, 2016, 128 eligible patients were randomly assigned to the pyrotinib (n = 65) or lapatinib (n = 63) treatment groups. The overall response rate was 78.5% (95% CI, 68.5% to 88.5%) with pyrotinib and 57.1% (95% CI, 44.9% to 69.4%) with lapatinib (treatment difference, 21.3%; 95% CI, 4.0% to 38.7%;  P  = .01). The median progression-free survival was 18.1 months (95% CI, 13.9 months to not reached) with pyrotinib and 7.0 months (95% CI, 5.6 to 9.8 months) with lapatinib (adjusted hazard ratio, 0.36; 95% CI, 0.23 to 0.58;  P  < .001). The most frequent grade 3 to 4 adverse events were hand-foot syndrome in 16 of 65 patients (24.6%) in the pyrotinib group versus 13 of 63 (20.6%) in the lapatinib group; diarrhea in 10 patients (15.4%) versus three patients (4.8%), respectively; and decreased neutrophil count in six patients (9.2%) versus two patients (3.2%), respectively.
CONCLUSION


In women with HER2-positive metastatic breast cancer previously treated with taxanes, anthracyclines, and/or trastuzumab, pyrotinib plus capecitabine yielded statistically significant better overall response rate and progression-free survival than lapatinib plus capecitabine in this randomized phase II trial.",2019,"The median progression-free survival was 18.1 months (95% CI, 13.9 months to not reached) with pyrotinib and 7.0 months (95% CI, 5.6 to 9.8 months) with lapatinib (adjusted hazard ratio, 0.36; 95% CI, 0.23 to 0.58;  P  < .001).","['HER2-Positive Metastatic Breast Cancer', 'women with HER2-positive metastatic breast cancer', 'Chinese patients with HER2-positive relapsed or metastatic breast cancer previously treated with', 'Between May 29, 2015, and March 15, 2016, 128 eligible patients', 'women with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer']","['400 mg pyrotinib or lapatinib', 'capecitabine', 'taxanes, anthracyclines, and/or trastuzumab', 'lapatinib', 'Prior Taxanes, Anthracyclines, and/or Trastuzumab', 'pyrotinib versus lapatinib, both in combination with capecitabine', 'lapatinib plus capecitabine', 'taxanes, anthracyclines, and/or trastuzumab, pyrotinib plus capecitabine', 'Pyrotinib or Lapatinib Combined With Capecitabine']","['investigator-assessed overall response rate per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1', 'overall response rate and progression-free survival', 'antitumor activity and acceptable tolerability', 'efficacy and tolerability', 'overall response rate', 'median progression-free survival', 'diarrhea', 'neutrophil count']","[{'cui': 'C4721209', 'cui_str': 'Metastasis from human epidermal growth factor 2 positive carcinoma of breast'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}]","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C3828434', 'cui_str': 'pyrotinib'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count (procedure)'}]",128.0,0.130717,"The median progression-free survival was 18.1 months (95% CI, 13.9 months to not reached) with pyrotinib and 7.0 months (95% CI, 5.6 to 9.8 months) with lapatinib (adjusted hazard ratio, 0.36; 95% CI, 0.23 to 0.58;  P  < .001).","[{'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ma', 'Affiliation': ""National Cancer Center, State Key Laboratory of Molecular Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Quchang', 'Initials': 'Q', 'LastName': 'Ouyang', 'Affiliation': ""Hunan Cancer Hospital, Changsha, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""First Affiliated Hospital, Jilin University, Changchun, People's Republic of China.""}, {'ForeName': 'Zefei', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': ""The Fifth Medical Center of Chinese PLA General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Zhongsheng', 'Initials': 'Z', 'LastName': 'Tong', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, Tianjin, People's Republic of China.""}, {'ForeName': 'Yunjiang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Cancer Center of Hebei Province and The Fourth Hospital of Hebei Medical University, Shijiazhuang, People's Republic of China.""}, {'ForeName': 'Huiping', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Peking University Cancer Hospital and Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Shiying', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': ""Tongji Hospital, Huazhong University of Science and Technology, Wuhan, People's Republic of China.""}, {'ForeName': 'Jifeng', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': ""Jiangsu Cancer Hospital, Nanjing, People's Republic of China.""}, {'ForeName': 'Shusen', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Sun Yat-sen University Cancer Center, Guangzhou, People's Republic of China.""}, {'ForeName': 'Xichun', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': ""Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.""}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': ""Jiangsu Hengrui Medicine, Shanghai, People's Republic of China.""}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': ""Jiangsu Hengrui Medicine, Shanghai, People's Republic of China.""}, {'ForeName': 'Binghe', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': ""National Cancer Center, State Key Laboratory of Molecular Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00108']
1887,31474119,Effects of Mobile Text Messaging on Glycemic Control in Patients With Coronary Heart Disease and Diabetes Mellitus: A Randomized Clinical Trial,"BACKGROUND


Mobile health interventions may support risk factor management and are readily scalable in healthcare systems. We aim to evaluate the efficacy of a text messaging-based intervention to improve glycemic control in patients with coronary heart disease and diabetes mellitus in China.
METHODS AND RESULTS


The CHAT-DM study (Cardiovascular Health and Texting-Diabetes Mellitus) was a parallel-group, single-blind, randomized clinical trial that included 502 patients with both coronary heart disease and diabetes mellitus from 34 hospitals in China. The intervention group (n=251) received 6 text messages per week for 6 months in addition to usual care. Messages were theory driven and culturally tailored to provide educational and motivational information on glucose monitoring, blood pressure control, medication adherence, physical activity, and lifestyle. The control group (n=251) received usual care and 2 thank you messages per month. The primary outcome was change in glycated hemoglobin (HbA 1C  [hemoglobin A 1C ]) from baseline to 6 months. Secondary outcomes were change in proportion of patients achieving HbA 1C  <7%, fasting blood glucose, systolic blood pressure, LDL (low-density lipoprotein) cholesterol, body mass index, and physical activity from baseline to 6 months. The end points were assessed using analyses of covariance. The follow-up rate was 99%. When compared with control group at 6 months, the intervention group had a greater reduction in HbA 1C  (-0.2% versus 0.1%; P=0.003) and a greater proportion of participants who achieved HbA 1C  <7% (69.3% versus 52.6%; P=0.004). Change in fasting blood glucose was larger in the intervention group (between-group difference: -0.6 mmol/L; 95% CI, -1.1 to -0.2; P=0.011), but no other outcome differences were observed. Nearly all participants reported that messages were easy to understand (97.1%) and useful (94.1%).
CONCLUSIONS


A text message intervention resulted in better glycemic control in patients with diabetes mellitus and coronary heart disease. While the mechanism of this benefit remains to be determined, the results suggest that a simple, culturally sensitive mobile text messaging program may provide an effective and feasible way to improve disease self-management.
CLINICAL TRIAL REGISTRATION


URL: http://www.clinicaltrials.gov. Unique identifier: NCT02883842.",2019,"When compared with control group at 6 months, the intervention group had a greater reduction in HbA 1C  (-0.2% versus 0.1%; P=0.003) and a greater proportion of participants who achieved HbA 1C  <7% (69.3% versus 52.6%; P=0.004).","['patients with coronary heart disease and diabetes mellitus in China', 'patients with diabetes mellitus and coronary heart disease', 'Patients With Coronary Heart Disease and Diabetes Mellitus', '502 patients with both coronary heart disease and diabetes mellitus from 34 hospitals in China']","['Mobile Text Messaging', 'text messaging-based intervention', '6 text messages per week for 6 months in addition to usual care', 'usual care and 2 thank you messages per month']","['reduction in HbA 1C', 'glucose monitoring, blood pressure control, medication adherence, physical activity, and lifestyle', 'Change in fasting blood glucose', 'change in proportion of patients achieving HbA 1C  <7%, fasting blood glucose, systolic blood pressure, LDL (low-density lipoprotein) cholesterol, body mass index, and physical activity', 'glycemic control', 'glycated hemoglobin (HbA 1C  [hemoglobin A 1C ']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019018', 'cui_str': 'Glycated Hemoglobin A'}]",502.0,0.124842,"When compared with control group at 6 months, the intervention group had a greater reduction in HbA 1C  (-0.2% versus 0.1%; P=0.003) and a greater proportion of participants who achieved HbA 1C  <7% (69.3% versus 52.6%; P=0.004).","[{'ForeName': 'Xiqian', 'Initials': 'X', 'LastName': 'Huo', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (X.H., X.B., H.Z., X.Y., Y.S., J. Liu, X.W., W.G., X.W., J.Li, X.L., X.Z.).'}, {'ForeName': 'Harlan M', 'Initials': 'HM', 'LastName': 'Krumholz', 'Affiliation': 'Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, CT (H.M.K., E.S.S., Q.D.).'}, {'ForeName': 'Xueke', 'Initials': 'X', 'LastName': 'Bai', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (X.H., X.B., H.Z., X.Y., Y.S., J. Liu, X.W., W.G., X.W., J.Li, X.L., X.Z.).'}, {'ForeName': 'Erica S', 'Initials': 'ES', 'LastName': 'Spatz', 'Affiliation': 'Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, CT (H.M.K., E.S.S., Q.D.).'}, {'ForeName': 'Qinglan', 'Initials': 'Q', 'LastName': 'Ding', 'Affiliation': 'Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, CT (H.M.K., E.S.S., Q.D.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Horak', 'Affiliation': 'Stanford University School of Medicine, CA (P.H.).'}, {'ForeName': 'Weigang', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Endocrinology, Key Laboratory of Endocrinology of Ministry of Health, Peking Union Medical College Hospital, Beijing, China (W.Z.).'}, {'ForeName': 'Qiuhong', 'Initials': 'Q', 'LastName': 'Gong', 'Affiliation': 'Endocrinology and Cardiovascular Disease Center, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, China (Q.G.).'}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (X.H., X.B., H.Z., X.Y., Y.S., J. Liu, X.W., W.G., X.W., J.Li, X.L., X.Z.).'}, {'ForeName': 'Xiaofang', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (X.H., X.B., H.Z., X.Y., Y.S., J. Liu, X.W., W.G., X.W., J.Li, X.L., X.Z.).'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (X.H., X.B., H.Z., X.Y., Y.S., J. Liu, X.W., W.G., X.W., J.Li, X.L., X.Z.).'}, {'ForeName': 'Jiamin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (X.H., X.B., H.Z., X.Y., Y.S., J. Liu, X.W., W.G., X.W., J.Li, X.L., X.Z.).'}, {'ForeName': 'Xuekun', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (X.H., X.B., H.Z., X.Y., Y.S., J. Liu, X.W., W.G., X.W., J.Li, X.L., X.Z.).'}, {'ForeName': 'Wenchi', 'Initials': 'W', 'LastName': 'Guan', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (X.H., X.B., H.Z., X.Y., Y.S., J. Liu, X.W., W.G., X.W., J.Li, X.L., X.Z.).'}, {'ForeName': 'Xiuling', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (X.H., X.B., H.Z., X.Y., Y.S., J. Liu, X.W., W.G., X.W., J.Li, X.L., X.Z.).'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (X.H., X.B., H.Z., X.Y., Y.S., J. Liu, X.W., W.G., X.W., J.Li, X.L., X.Z.).'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (X.H., X.B., H.Z., X.Y., Y.S., J. Liu, X.W., W.G., X.W., J.Li, X.L., X.Z.).'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': ""Health Outcomes Research, Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.).""}, {'ForeName': 'Frederick A', 'Initials': 'FA', 'LastName': 'Masoudi', 'Affiliation': 'Division of Cardiology, University of Colorado Anschutz Medical Campus, Aurora (F.A.M.).'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (X.H., X.B., H.Z., X.Y., Y.S., J. Liu, X.W., W.G., X.W., J.Li, X.L., X.Z.).'}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.119.005805']
1888,31888947,Feasibility study of early outpatient review and early cardiac rehabilitation after cardiac surgery: mixed-methods research design-a study protocol.,"INTRODUCTION


Following cardiac surgery, patients currently attend an outpatient review 6 weeks after hospital discharge, where recovery is assessed and suitability to commence cardiac rehabilitation (CR) is determined. CR is then started from 8 weeks. Following a median sternotomy, cardiac surgery patients are required to refrain from upper body exercises, lifting of heavy objects and other strenuous activities for 12 weeks. A delay in starting CR can prolong the recovery process, increase dependence on family/carers and can cause frustration. However, current guidelines for activity and exercise after median sternotomy have been described as restrictive, anecdotal and increasingly at odds with modern clinical guidance for CR. This study aims to examine the feasibility of bringing forward outpatient review and starting CR earlier.
METHODS AND ANALYSES


This is a multicentre, randomised controlled, open feasibility trial comparing postoperative outpatient review 6 weeks after hospital discharge, followed by CR commencement from 8 weeks (control arm) versus, postoperative outpatient review 3 weeks after hospital discharge, followed by commencement of CR from 4 weeks (intervention arm). The study aims to recruit 100 eligible patients, aged 18-80 years who have undergone elective or urgent cardiac surgery involving a full median sternotomy, over a 7-month period across two centres. Feasibility will be measured by consent, recruitment, retention rates and attendance at appointments and CR sessions. Qualitative interviews with trial participants and staff will explore issues around study processes and acceptability of the intervention and the findings integrated with the feasibility trial outcomes to inform the design of a future full-scale randomised controlled trial.
ETHICS AND DISSEMINATION


Ethics approval was granted by East Midlands-Derby Research Ethics Committee on 10 January 2019. The findings will be presented at relevant conferences disseminated via peer-reviewed research publications, and to relevant stakeholders.
TRIAL REGISTRATION NUMBER


ISRCTN80441309.",2019,"A delay in starting CR can prolong the recovery process, increase dependence on family/carers and can cause frustration.","['100 eligible patients, aged 18-80 years who have undergone elective or urgent cardiac surgery involving a full median sternotomy, over a 7-month period across two centres', 'early outpatient review and early cardiac rehabilitation after cardiac surgery']",['cardiac surgery'],[],"[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C1282959', 'cui_str': 'Median Sternotomy'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}]","[{'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}]",[],,0.289059,"A delay in starting CR can prolong the recovery process, increase dependence on family/carers and can cause frustration.","[{'ForeName': 'Dumbor', 'Initials': 'D', 'LastName': 'Ngaage', 'Affiliation': 'Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust, Hull, UK dumbor.ngaage@hey.nhs.uk.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Mitchell', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Dean', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Hirst', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Enoch', 'Initials': 'E', 'LastName': 'Akowuah', 'Affiliation': 'James Cook Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'Patrick Joseph', 'Initials': 'PJ', 'LastName': 'Doherty', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Fairhurst', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Flemming', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hewitt', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Hinde', 'Affiliation': 'Centre for Health Economics, University of York, York, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Mitchell', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Nichols', 'Affiliation': 'Centre for Sport and Exercise Science, Sheffield Hallam University - Collegiate Crescent Campus, Sheffield, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Watson', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}]",BMJ open,['10.1136/bmjopen-2019-035787']
1889,32077231,"The methionine aminopeptidase 2 inhibitor ZGN-1061 improves glucose control and weight in overweight and obese individuals with type 2 diabetes: A randomized, placebo-controlled trial.","The methionine aminopeptidase 2 (MetAP2) inhibitor ZGN-1061 lowered weight and improved glucose in preclinical studies. We sought to determine its efficacy and safety by performing a multicentre, phase 2, randomized controlled trial involving overweight and obese adults with type 2 diabetes and HbA1c between 7% and 11% inclusive. Participants were randomized to receive subcutaneous treatment with placebo or 0.05, 0.3, 0.9 or 1.8 mg ZGN-1061 every third day for 12 weeks. The primary outcome was change in HbA1c at week 12. Relative to placebo, the 0.9 and 1.8 mg doses induced clinically meaningful reductions in HbA1c of 0.6% (95% CI 0.2% to 0.9%; P = 0.0006) and 1.0% (95% CI 0.6% to 1.4%; P < 0.0001), respectively. The 1.8 mg dose also induced weight loss of 2.2% (95% CI 1.1% to 3.3%; P = 0.0002). The incidence of adverse events was balanced across the treatment groups. We conclude that MetAP2 inhibition with ZGN-1061 for 12 weeks improved glucose control and aided weight loss in overweight and obese people with type 2 diabetes. However, given safety issues, Zafgen has discontinued MetAP2 inhibitor development.",2020,"Relative to placebo, the 0.9mg and 1.8mg doses induced clinically meaningful reductions in HbA1c of 0.6% (95% CI 0.2 to 0.9; p=0.0006) and 1.0% (95% CI 0.6 to 1.4; p<0.0001) respectively.","['overweight and obese adults with type 2 diabetes and HbA1c between 7 and 11% inclusive', 'overweight and obese people with type 2 diabetes', 'overweight and obese individuals with type 2 diabetes']","['placebo', 'ZGN-1061', 'inhibitor ZGN-1061', 'methionine aminopeptidase']","['efficacy and safety', 'weight loss', 'adverse events', 'glucose control and weight', 'glucose control and aided weight loss']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0127863', 'cui_str': 'Peptidase M'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}]",,0.344206,"Relative to placebo, the 0.9mg and 1.8mg doses induced clinically meaningful reductions in HbA1c of 0.6% (95% CI 0.2 to 0.9; p=0.0006) and 1.0% (95% CI 0.6 to 1.4; p<0.0001) respectively.","[{'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Wentworth', 'Affiliation': 'Department of Diabetes and Endocrinology, Royal Melbourne Hospital, Parkville, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Colman', 'Affiliation': 'Department of Diabetes and Endocrinology, Royal Melbourne Hospital, Parkville, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Zafgen, Boston, Massachusetts.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14009']
1890,31469393,Effect of Sequential or Active Choice for Colorectal Cancer Screening Outreach: A Randomized Clinical Trial.,"Importance


Colonoscopy and fecal immunochemical testing (FIT) are considered top-tier tests for colorectal cancer (CRC) screening. Behavioral economic insights about ""choice architecture"" suggest that participation could be influenced by how people are presented test options.
Objective


To investigate response rates for offering colonoscopy only compared with sequential choice (colonoscopy and then FIT) or active choice (colonoscopy or FIT) through mailed outreach.
Design, Setting, and Participants


Three-arm pragmatic randomized clinical trial conducted between November 14, 2017, and May 14, 2018. The setting was primary care practices at an academic health system. Patients aged 50 to 74 years with at least 2 primary care visits in the 2-year preenrollment period were included if they were eligible but not up to date on CRC screening.
Interventions


Eligible patients received mailed outreach about CRC screening. Equal numbers of eligible patients were randomly assigned to 3 outreach groups to receive mailings about CRC screening with the following options: (1) direct phone number to call for scheduling colonoscopy (colonoscopy only), (2) direct phone number to call for colonoscopy and a mailed FIT kit if no response within 4 weeks (sequential choice), or (3) direct phone number to call for colonoscopy and a mailed FIT kit offered at the same time (active choice).
Main Outcomes and Measures


The primary outcome was CRC screening completion (FIT or colonoscopy) within 4 months of initial outreach. The secondary outcomes were CRC screening completion within 6 months of outreach and the choice of colonoscopy as a screening test.
Results


In total, 438 patients were included in the intent-to-treat analysis, with a median age of 56 years (interquartile range, 52-63 years); 55.0% were women. At 4 months, the CRC screening completion rates were 14.4% (95% CI, 8.7%-20.1%) in the colonoscopy-only arm, 17.1% (95% CI, 11.0%-23.2%) in the sequential choice arm, and 19.9% (95% CI, 13.4%-26.4%) in the active choice arm. Neither choice arm achieved a screening rate statistically greater than that in the colonoscopy-alone arm. Among those who completed CRC screening at 4 months, 90.5% (95% CI, 78.0%-103.0%) chose colonoscopy in the colonoscopy-only arm, which was significantly higher than the 52.0% (95% CI, 32.4%-71.6%; P = .005) and 37.9% (95% CI, 20.2%-55.6%; P < .001) in the sequential choice and active choice arms, respectively.
Conclusions and Relevance


There was no significant increase in CRC screening when offering sequential or active choice, but there was a lower rate of colonoscopy in the choice arms than in the colonoscopy-only arm. Subtle changes in sequencing or defaults can alter patient decision making related to preventive health.
Trial Registration


ClinicalTrials.gov identifier: NCT03246438.",2019,"There was no significant increase in CRC screening when offering sequential or active choice, but there was a lower rate of colonoscopy in the choice arms than in the colonoscopy-only arm.","['438 patients were included in the intent-to-treat analysis, with a median age of 56 years (interquartile range, 52-63 years); 55.0% were women', 'Patients aged 50 to 74 years with at least 2 primary care visits in the 2-year preenrollment period were included if they were eligible but not up to date on CRC screening', 'Colorectal Cancer Screening Outreach', 'Equal numbers of eligible patients', 'Participants\n\n\nThree-arm pragmatic randomized clinical trial conducted between November 14, 2017, and May 14, 2018']","['sequential choice (colonoscopy and then FIT) or active choice (colonoscopy or FIT', 'mailed outreach about CRC screening', 'Importance\n\n\nColonoscopy and fecal immunochemical testing (FIT', 'mailings about CRC screening with the following options: (1) direct phone number to call for scheduling colonoscopy (colonoscopy only), (2) direct phone number to call for colonoscopy and a mailed FIT kit if no response within 4 weeks (sequential choice), or (3) direct phone number to call for colonoscopy and a mailed FIT kit offered at the same time (active choice', 'Sequential or Active Choice']","['CRC screening', 'CRC screening completion rates', 'screening rate', 'rate of colonoscopy', 'CRC screening completion within 6 months of outreach and the choice of colonoscopy as a screening test', 'CRC screening completion (FIT or colonoscopy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C1515258', 'cui_str': 'Telephone number (property) (qualifier value)'}, {'cui': 'C1446911', 'cui_str': 'Scheduling'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}]",438.0,0.191216,"There was no significant increase in CRC screening when offering sequential or active choice, but there was a lower rate of colonoscopy in the choice arms than in the colonoscopy-only arm.","[{'ForeName': 'Shivan J', 'Initials': 'SJ', 'LastName': 'Mehta', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Vikranth', 'Initials': 'V', 'LastName': 'Induru', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Santos', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Reitz', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'McAuliffe', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Orellana', 'Affiliation': 'Clinical Care Associates, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Volpp', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Asch', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Chyke A', 'Initials': 'CA', 'LastName': 'Doubeni', 'Affiliation': 'Department of Family Medicine and Community Health, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.10305']
1891,31462136,Home-based tele-rehabilitation presents comparable positive impact on self-reported functional outcomes as usual care: The Singapore Tele-technology Aided Rehabilitation in Stroke randomised trial.,"INTRODUCTION


The aim of this research was to evaluate the impact of a novel tele-rehabilitation system on self-reported functional outcomes compared to usual care during the first three months after stroke.
METHODS


A parallel, two-arm, evaluator-blinded, randomised controlled trial was conducted. Adults aged ≥40 years who had suffered a stroke within four weeks of the start of the study were recruited from the general community. The intervention group received access to a novel tele-rehabilitation system and programme for three months. The primary outcome measures utilised were the frequency and limitation total scores of the Late-Life Function and Disability Instrument (LLFDI) at three months.
RESULTS


A total of 124 individuals were recruited. The mean differences in the LLDFI frequency and limitation total scores at three months comparing the intervention and control groups were -3.30 (95% confidence interval (CI) -7.81 to 1.21) and -6.90 (95% CI -15.02 to 1.22), respectively. Adjusting for the respective baseline covariates and baseline Barthel Index also showed no significant difference between interventions in the LLFDI outcomes.
DISCUSSION


The intervention and control groups self-reported similar improvements in functional outcomes. Tele-rehabilitation may be a viable option to provide post-stroke rehabilitation services in Singapore while reducing barriers to continue rehabilitation conventionally after discharge from hospital and encouraging more participation.",2019,,[],['Home-based tele-rehabilitation'],[],[],"[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4042802', 'cui_str': 'Tele-rehabilitation'}]",[],,0.0492954,,"[{'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Asano', 'Affiliation': 'National University of Singapore, Saw Swee Hock School of Public Health, Singapore.'}, {'ForeName': 'Bee C', 'Initials': 'BC', 'LastName': 'Tai', 'Affiliation': 'National University of Singapore, Saw Swee Hock School of Public Health, Singapore.'}, {'ForeName': 'Felicity Yt', 'Initials': 'FY', 'LastName': 'Yeo', 'Affiliation': 'National University of Singapore, Saw Swee Hock School of Public Health, Singapore.'}, {'ForeName': 'Shi C', 'Initials': 'SC', 'LastName': 'Yen', 'Affiliation': 'Department of Electrical and Computer Engineering, National University of Singapore, Singapore.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Tay', 'Affiliation': 'Department of Electrical and Computer Engineering, National University of Singapore, Singapore.'}, {'ForeName': 'Yee S', 'Initials': 'YS', 'LastName': 'Ng', 'Affiliation': 'Department of Rehabilitation Medicine, Singapore General Hospital, Singapore.'}, {'ForeName': 'Deidre A', 'Initials': 'DA', 'LastName': 'De Silva', 'Affiliation': 'Department of Neurology, National Neuroscience Institute, Singapore.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Caves', 'Affiliation': 'Department of Surgery, Duke University Medical Center, USA.'}, {'ForeName': 'Eiffie', 'Initials': 'E', 'LastName': 'Chew', 'Affiliation': 'Department of Rehabilitation Medicine, National University Hospital, Singapore.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hoenig', 'Affiliation': 'Physical Medicine and Rehabilitation Service, Durham Veterans Affairs Medical Center, USA.'}, {'ForeName': 'Gerald C', 'Initials': 'GC', 'LastName': 'Koh', 'Affiliation': 'National University of Singapore, Saw Swee Hock School of Public Health, Singapore.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19868905']
1892,31194613,Erlotinib Versus Gemcitabine Plus Cisplatin as Neoadjuvant Treatment of Stage IIIA-N2  EGFR -Mutant Non-Small-Cell Lung Cancer (EMERGING-CTONG 1103): A Randomized Phase II Study.,"PURPOSE


To assess the benefits of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors as neoadjuvant/adjuvant therapies in locally advanced  EGFR  mutation-positive non-small-cell lung cancer.
PATIENTS AND METHODS


This was a multicenter (17 centers in China), open-label, phase II, randomized controlled trial of erlotinib versus gemcitabine plus cisplatin (GC chemotherapy) as neoadjuvant/adjuvant therapy in patients with stage IIIA-N2 non-small-cell lung cancer with  EGFR  mutations in exon 19 or 21 (EMERGING). Patients received erlotinib 150 mg/d (neoadjuvant therapy, 42 days; adjuvant therapy, up to 12 months) or gemcitabine 1,250 mg/m 2  plus cisplatin 75 mg/m 2  (neoadjuvant therapy, two cycles; adjuvant therapy, up to two cycles). Assessments were performed at 6 weeks and every 3 months postsurgery. The primary end point was objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; secondary end points were pathologic complete response, progression-free survival (PFS), overall survival, safety, and tolerability.
RESULTS


Of 386 patients screened, 72 were randomly assigned to treatment (intention-to-treat population), and 71 were included in the safety analysis (one patient withdrew before treatment). The ORR for neoadjuvant erlotinib versus GC chemotherapy was 54.1% versus 34.3% (odds ratio, 2.26; 95% CI, 0.87 to 5.84;  P  = .092). No pathologic complete response was identified in either arm. Three (9.7%) of 31 patients and zero of 23 patients in the erlotinib and GC chemotherapy arms, respectively, had a major pathologic response. Median PFS was significantly longer with erlotinib (21.5 months) versus GC chemotherapy (11.4 months; hazard ratio, 0.39; 95% CI, 0.23 to 0.67;  P  < .001). Observed adverse events reflected those most commonly seen with the two treatments.
CONCLUSION


The primary end point of ORR with 42 days of neoadjuvant erlotinib was not met, but the secondary end point PFS was significantly improved.",2019,"Median PFS was significantly longer with erlotinib (21.5 months) versus GC chemotherapy (11.4 months; hazard ratio, 0.39; 95% CI, 0.23 to 0.67;  P  < .001).","['multicenter (17 centers in China), open-label, phase II', 'patients with stage IIIA-N2 non-small-cell lung cancer with  EGFR  mutations in exon 19 or 21', '386 patients screened, 72 were randomly assigned to treatment (intention-to-treat population), and 71 were included in the safety analysis (one patient withdrew before treatment']","['erlotinib versus gemcitabine plus cisplatin (GC chemotherapy', 'epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors', 'Erlotinib Versus Gemcitabine Plus Cisplatin', 'erlotinib 150 mg/d (neoadjuvant therapy', 'GC chemotherapy', 'gemcitabine 1,250 mg/m 2  plus cisplatin 75 mg/m 2  (neoadjuvant therapy']","['major pathologic response', 'objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors', 'pathologic complete response', 'ORR', 'pathologic complete response, progression-free survival (PFS), overall survival, safety, and tolerability', 'Median PFS']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457162', 'cui_str': 'Stage IIIa'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}]","[{'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0034802', 'cui_str': 'c-erbB-1 Protein'}, {'cui': 'C0033681', 'cui_str': 'Tyrosylprotein Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2978152', 'cui_str': 'erlotinib 150 MG [Tarceva]'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",72.0,0.11076,"Median PFS was significantly longer with erlotinib (21.5 months) versus GC chemotherapy (11.4 months; hazard ratio, 0.39; 95% CI, 0.23 to 0.67;  P  < .001).","[{'ForeName': 'Wen-Zhao', 'Initials': 'WZ', 'LastName': 'Zhong', 'Affiliation': ""Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, People's Republic of China.""}, {'ForeName': 'Ke-Neng', 'Initials': 'KN', 'LastName': 'Chen', 'Affiliation': ""Peking University Cancer Hospital and Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': ""Fujian Medical University Union Hospital, Fuzhou, People's Republic of China.""}, {'ForeName': 'Chun-Dong', 'Initials': 'CD', 'LastName': 'Gu', 'Affiliation': ""First Affiliated Hospital of Dalian Medical University, Dalian, People's Republic of China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Peking University People's Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Xue-Ning', 'Initials': 'XN', 'LastName': 'Yang', 'Affiliation': ""Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, People's Republic of China.""}, {'ForeName': 'Wei-Min', 'Initials': 'WM', 'LastName': 'Mao', 'Affiliation': ""Zhejiang Cancer Hospital, Hangzhou, People's Republic of China.""}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Zhongshan Hospital, Shanghai, People's Republic of China.""}, {'ForeName': 'Gui-Bin', 'Initials': 'GB', 'LastName': 'Qiao', 'Affiliation': ""Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, People's Republic of China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': ""Jilin Provincial Tumor Hospital, Changchun, People's Republic of China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ""Jiangsu Cancer Institute and Hospital, Nanjing, People's Republic of China.""}, {'ForeName': 'Chang-Li', 'Initials': 'CL', 'LastName': 'Wang', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, Tianjin, People's Republic of China.""}, {'ForeName': 'Ming-Wei', 'Initials': 'MW', 'LastName': 'Chen', 'Affiliation': ""First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, People's Republic of China.""}, {'ForeName': 'Xiaozheng', 'Initials': 'X', 'LastName': 'Kang', 'Affiliation': ""Peking University Cancer Hospital and Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Wanpu', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': ""Peking University Cancer Hospital and Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Hong-Hong', 'Initials': 'HH', 'LastName': 'Yan', 'Affiliation': ""Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, People's Republic of China.""}, {'ForeName': 'Ri-Qiang', 'Initials': 'RQ', 'LastName': 'Liao', 'Affiliation': ""Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, People's Republic of China.""}, {'ForeName': 'Jin-Ji', 'Initials': 'JJ', 'LastName': 'Yang', 'Affiliation': ""Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, People's Republic of China.""}, {'ForeName': 'Xu-Chao', 'Initials': 'XC', 'LastName': 'Zhang', 'Affiliation': ""Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, People's Republic of China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': ""Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yi-Long', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': ""Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, People's Republic of China.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00075']
1893,31446990,Oral vinorelbine versus etoposide with cisplatin and chemo-radiation as treatment in patients with stage III non-small cell lung cancer: A randomized phase II (RENO study).,"OBJECTIVES


Concomitant chemo-radiation is the standard treatment for unresectable stage III non-small cell lung cancer (LA-NSCLC). The aim of this study was to assess the safety and efficacy of oral vinorelbine and cisplatin (OVP) compared with etoposide and cisplatin (EP), both in combination with radiotherapy, in this setting.
MATERIAL AND METHODS


An open-label, randomized phase II trial was undertaken including 23 hospitals in Spain. Adults with untreated unresectable stage III NSCLC were randomized1:1 to receive: oral vinorelbine (days 1 and 8 with cisplatin on day 1 in 3-week cycles; 2 cycles of induction, 2 cycles in concomitance) or etoposide (days 1-5 and 29-32 with cisplatin on days 1 and 8 in 4-week cycles; 2 cycles in concomitance). Both groups received concomitant radiotherapy 2 Gy/day (66 Gy). The primary endpoint was progression free survival (PFS).
RESULTS


One hundred and forty patients were enrolled. Sixty-nine patients received OVP and 71 received EP. Globally adverse events grade 3/4 per cycle were fewer in the vinorelbine arm (19.4%) than in the etoposide arm (62.6%) (p < 0.001). One patient (1.5%) in the OVP arm and 12 pts (17.6%) in the EP arm presented esophagitis grade 3/4 (p = 0.002). Median PFS was similar in both groups (10.8 [95% CI 7.7-13.8] and 9.6 months [95% CI 4.4-14.8]; p = 0.457, respectively). Preliminary median overall survival was 30 months in the OVP arm and 31.9 months in the EP arm (p = 0.688).
CONCLUSIONS


Our findings show that OVP could be considered a standard combination with similar efficacy and better safety profile for the treatment of LA-NSCLC patients.",2019,Globally adverse events grade 3/4 per cycle were fewer in the vinorelbine arm (19.4%) than in the etoposide arm (62.6%) (p < 0.001).,"['patients with stage III non-small cell lung cancer', 'Adults with untreated unresectable stage III NSCLC', 'unresectable stage III non-small cell lung cancer (LA-NSCLC', '23 hospitals in Spain', 'One hundred and forty patients were enrolled']","['oral vinorelbine', 'oral vinorelbine and cisplatin (OVP', 'vinorelbine', 'concomitant radiotherapy', 'EP', 'Oral vinorelbine versus etoposide with cisplatin and chemo-radiation', 'cisplatin', 'etoposide', 'etoposide and cisplatin (EP), both in combination with radiotherapy', 'OVP']","['progression free survival (PFS', 'Median PFS', 'median overall survival', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",140.0,0.128498,Globally adverse events grade 3/4 per cycle were fewer in the vinorelbine arm (19.4%) than in the etoposide arm (62.6%) (p < 0.001).,"[{'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Isla', 'Affiliation': 'Medical Oncology, University Hospital Clínico Lozano Blesa, Zaragoza, Spain.'}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'De Las Peñas', 'Affiliation': 'Medical Oncology, Provincial Hospital de Castellón, Castellón, Spain.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Insa', 'Affiliation': 'Medical Oncology, University Hospital Clínic, Valencia, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Marsé', 'Affiliation': 'Medical Oncology, University Hospital Son Espases, Palma De Mallorca, Spain.'}, {'ForeName': 'Natividad', 'Initials': 'N', 'LastName': 'Martínez-Banaclocha', 'Affiliation': 'Medical Oncology, General University Hospital de Elche, Elche, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Mut', 'Affiliation': 'Medical Oncology, Hospital Son Llàtzer, Palma De Mallorca, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Morán', 'Affiliation': 'Medical Oncology, Catalan Institute of Oncology, Hospital Universitari Germans Triasi Pujol, Universitat Autònoma de Barcelona, Badalona, Spain.'}, {'ForeName': 'María Ángeles', 'Initials': 'MÁ', 'LastName': 'Sala', 'Affiliation': 'Medical Oncology, University Hospital Basurto, Bilbao, Spain.'}, {'ForeName': 'Bartomeu', 'Initials': 'B', 'LastName': 'Massuti', 'Affiliation': 'Medical Oncology, General University Hospital de Alicante, Alicante, Spain.'}, {'ForeName': 'Ana Laura', 'Initials': 'AL', 'LastName': 'Ortega', 'Affiliation': 'Medical Oncology, Hospitality complex of Jaén, Jaén, Spain.'}, {'ForeName': 'José Miguel', 'Initials': 'JM', 'LastName': 'Jurado', 'Affiliation': 'Medical Oncology, University Hospital San Cecilio, Granada, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Gómez-Codina', 'Affiliation': 'Medical Oncology, University and Polytechnic Hospital La Fe, Valencia, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Diz', 'Affiliation': 'Medical Oncology, Assistent Complex of León, Léon, Spain.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Artal', 'Affiliation': 'Medical Oncology, University Hospital Miguel Servet, Zaragoza, Spain.'}, {'ForeName': 'Vanesa', 'Initials': 'V', 'LastName': 'Gutiérrez', 'Affiliation': 'Medical Oncology, Regional University Hospital of Málaga, Málaga, Spain.'}, {'ForeName': 'María Francisca', 'Initials': 'MF', 'LastName': 'Vázquez', 'Affiliation': 'Medical Oncology, University Hospitality Complex of Santiago, Santiago de Compostela, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Viñolas', 'Affiliation': 'Medical Oncology, University Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Maestu', 'Affiliation': 'Medical Oncology, University Hospital Doctor Peset, Valencia, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Camps', 'Affiliation': 'Medical Oncology, General University Hospital of Valencia, Centro de Investigación Biomédica en Red de Cáncer. Department of Medicine, Universitat de València, Valencia, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Álvarez', 'Affiliation': 'Medical Oncology, General University Hospital of Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Melchor Álvarez', 'Initials': 'MÁ', 'LastName': 'de Mon Soto', 'Affiliation': 'Medical Oncology, University Hospital of Príncipe de Asturias, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Ponce', 'Affiliation': 'Medical Oncology, University Hospital 12 de Ocutbre, Spain.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Provencio', 'Affiliation': 'Medical Oncology, University Hospital Puerta de Hierro, Majadahonda Medical Oncology. Spanish Lung Cancer Group (SLCG), Spain. Electronic address: mariano.provencio@salud.madrid.org.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2018.11.041']
1894,30629474,Two weeks of exercise training intensity on appetite regulation in obese adults with prediabetes.,"No short-term exercise data exist testing whether training intensity modifies hormonal and perceived appetite in obese adults with prediabetes. Therefore, we compared the effects of short-term moderate-continuous (CONT) vs. high-intensity interval (INT) training on appetite regulation. Twenty-eight obese adults [age: 61.3 ± 1.5 yr; body mass index (BMI): 33.2 ± 1.1 kg/m 2 ] with prediabetes were randomized to work-matched CONT ( n = 14) or INT ( n = 14) training for 2 wk. Plasma acylated ghrelin (AG), des-acylated ghrelin (dAG), active glucagon-like peptide-1 (GLP-1), and insulin were measured at 0, 30, and 60 min of a 75-g oral glucose tolerance test (OGTT) before and after training. Visual analog scales were administered at 0 and 120 min during the OGTT to examine perceived appetite. Three-day food logs were collected before and after testing to assess ad libitum diet. CONT and INT increased peak oxygen consumption ( P < 0.01) and decreased BMI ( P < 0.01). Although neither intervention altered fasting levels of AG ( P = 0.94), dAG ( P = 0.36), or insulin ( P = 0.67), CONT raised GLP-1 compared with INT ( P = 0.05). Exercise training did not affect postprandial suppression of AG ( P = 0.81) and dAG ( P = 0.67) or stimulation of GLP-1 ( P = 0.67) and insulin ( P = 0.32). Both interventions tended to decrease total energy and protein intake ( P = 0.09 and P = 0.05, respectively), despite no change in fasting hunger ( P = 0.88) and reduced perceived fullness at 120 min during the OGTT ( P = 0.05). We conclude that 2 wk of exercise training intensity does not modulate appetite-regulatory hormones in obese adults with prediabetes. Although perceived fullness to the OGTT was reduced after exercise, CONT and INT decreased energy intake, suggesting that exercise does not elicit compensatory appetite behavior to gain weight. NEW & NOTEWORTHY Adults with prediabetes are at risk for appetite dysregulation. Although exercise promotes weight management, it is unclear whether moderate-continuous or high-intensity interval training is more beneficial for appetite regulation. We show that 2 wk of exercise, independent of intensity, does not alter postprandial appetite hormones or hunger, despite slight reductions in food intake and weight. These data support exercise as an effective method to induce negative energy balance without compensatory weight gain.",2019,CONT and INT increased peak oxygen consumption ( P < 0.01) and decreased BMI ( P < 0.01).,"['obese adults with prediabetes', 'Twenty-eight obese adults [age: 61.3\u2009±\u20091.5 yr; body mass index (BMI): 33.2\u2009±\u20091.1 kg/m 2 ] with prediabetes', 'Adults with prediabetes are at risk for appetite dysregulation']","['short-term moderate-continuous (CONT) vs. high-intensity interval (INT) training', 'INT', 'Exercise training', 'exercise training intensity']","['BMI', 'postprandial suppression of AG', 'total energy and protein intake', 'fasting hunger', 'postprandial appetite hormones or hunger', 'CONT and INT increased peak oxygen consumption', 'appetite-regulatory hormones', 'fasting levels of AG', 'Visual analog scales', 'perceived fullness', 'stimulation of GLP-1', 'appetite regulation', 'Plasma acylated ghrelin (AG), des-acylated ghrelin (dAG), active glucagon-like peptide-1 (GLP-1), and insulin']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0003622', 'cui_str': 'Appetite Regulation'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin (substance)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]",28.0,0.0352833,CONT and INT increased peak oxygen consumption ( P < 0.01) and decreased BMI ( P < 0.01).,"[{'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Heiston', 'Affiliation': 'Department of Kinesiology, University of Virginia , Charlottesville, Virginia.'}, {'ForeName': 'Natalie Z M', 'Initials': 'NZM', 'LastName': 'Eichner', 'Affiliation': 'Department of Kinesiology, University of Virginia , Charlottesville, Virginia.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Gilbertson', 'Affiliation': 'Department of Kinesiology, University of Virginia , Charlottesville, Virginia.'}, {'ForeName': 'Julian M', 'Initials': 'JM', 'LastName': 'Gaitán', 'Affiliation': 'Department of Kinesiology, University of Virginia , Charlottesville, Virginia.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Kranz', 'Affiliation': 'Department of Kinesiology, University of Virginia , Charlottesville, Virginia.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Weltman', 'Affiliation': 'Department of Kinesiology, University of Virginia , Charlottesville, Virginia.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Malin', 'Affiliation': 'Department of Kinesiology, University of Virginia , Charlottesville, Virginia.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00655.2018']
1895,31411950,Gefitinib Versus Gefitinib Plus Pemetrexed and Carboplatin Chemotherapy in  EGFR -Mutated Lung Cancer.,"PURPOSE


Standard first-line therapy for  EGFR -mutant advanced non-small-cell lung cancer (NSCLC) is an epidermal growth factor receptor (EGFR)-directed oral tyrosine kinase inhibitor. Adding pemetrexed and carboplatin chemotherapy to an oral tyrosine kinase inhibitor may improve outcomes.
PATIENTS AND METHODS


This was a phase III randomized trial in patients with advanced NSCLC harboring an  EGFR -sensitizing mutation and a performance status of 0 to 2 who were planned to receive first-line palliative therapy. Random assignment was 1:1 to gefitinib 250 mg orally per day (Gef) or gefitinib 250 mg orally per day plus pemetrexed 500 mg/m 2  and carboplatin area under curve 5 intravenously every 3 weeks for four cycles, followed by maintenance pemetrexed (gefitinib plus chemotherapy [Gef+C]). The primary end point was progression-free survival (PFS); secondary end points included overall survival (OS), response rate, and toxicity.
RESULTS


Between 2016 and 2018, 350 patients were randomly assigned to Gef (n = 176) and Gef+C (n = 174). Twenty-one percent of patients had a performance status of 2, and 18% of patients had brain metastases. Median follow-up time was 17 months (range, 7 to 30 months). Radiologic response rates were 75% and 63% in the Gef+C and Gef arms, respectively ( P  = .01). Estimated median PFS was significantly longer with Gef+C than Gef (16 months [95% CI, 13.5 to 18.5 months]  v  8 months [95% CI, 7.0 to 9.0 months], respectively; hazard ratio for disease progression or death, 0.51 [95% CI, 0.39 to 0.66];  P  < .001). Estimated median OS was significantly longer with Gef+C than Gef (not reached  v  17 months [95% CI, 13.5 to 20.5 months]; hazard ratio for death, 0.45 [95% CI, 0.31 to 0.65];  P  < .001). Clinically relevant grade 3 or greater toxicities occurred in 51% and 25% of patients in the Gef+C and Gef arms, respectively ( P  < .001).
CONCLUSION


Adding pemetrexed and carboplatin chemotherapy to gefitinib significantly prolonged PFS and OS but increased toxicity in patients with NSCLC.",2020,Estimated median OS was significantly longer with Gef+C than Gef (not reached  v  17 months,"['350 patients were randomly assigned to Gef (n = 176) and Gef+C (n = 174', 'EGFR -mutant advanced non-small-cell lung cancer (NSCLC', 'EGFR -Mutated Lung Cancer', 'Between 2016 and 2018', 'patients with advanced NSCLC harboring an  EGFR -sensitizing mutation and a performance status of 0 to 2 who were', 'patients with NSCLC']","['planned to receive first-line palliative therapy', 'pemetrexed (gefitinib plus chemotherapy [Gef+C', 'Gefitinib Versus Gefitinib Plus Pemetrexed and Carboplatin Chemotherapy', 'Gef+C', 'gefitinib 250 mg orally per day (Gef) or gefitinib 250 mg orally per day plus pemetrexed 500 mg/m 2  and carboplatin', 'pemetrexed and carboplatin chemotherapy']","['Estimated median PFS', 'hazard ratio for death', 'brain metastases', 'overall survival (OS), response rate, and toxicity', 'Radiologic response rates', 'progression-free survival (PFS', 'hazard ratio for disease progression or death', 'Clinically relevant grade 3 or greater toxicities', 'Estimated median OS', 'toxicity']","[{'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0475311', 'cui_str': 'Harbor (environment)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0030231', 'cui_str': 'Palliative Supportive Care'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C1176914', 'cui_str': 'gefitinib 250 MG'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C4074670', 'cui_str': 'pemetrexed 500 MG'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain (disorder)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205483', 'cui_str': 'Radiologic (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]",350.0,0.130639,Estimated median OS was significantly longer with Gef+C than Gef (not reached  v  17 months,"[{'ForeName': 'Vanita', 'Initials': 'V', 'LastName': 'Noronha', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Vijay Maruti', 'Initials': 'VM', 'LastName': 'Patil', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Joshi', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Nandini', 'Initials': 'N', 'LastName': 'Menon', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Chougule', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Mahajan', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Janu', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Nilendu', 'Initials': 'N', 'LastName': 'Purandare', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Sucheta', 'Initials': 'S', 'LastName': 'More', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Supriya', 'Initials': 'S', 'LastName': 'Goud', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Nandkumar', 'Initials': 'N', 'LastName': 'Kadam', 'Affiliation': 'Gunvati J. Kapoor Medical Relief Charitable Foundation, Mumbai, India.'}, {'ForeName': 'Nilesh', 'Initials': 'N', 'LastName': 'Daware', 'Affiliation': 'Gunvati J. Kapoor Medical Relief Charitable Foundation, Mumbai, India.'}, {'ForeName': 'Atanu', 'Initials': 'A', 'LastName': 'Bhattacharjee', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Srushti', 'Initials': 'S', 'LastName': 'Shah', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Akanksha', 'Initials': 'A', 'LastName': 'Yadav', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Vaishakhi', 'Initials': 'V', 'LastName': 'Trivedi', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Vichitra', 'Initials': 'V', 'LastName': 'Behel', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Dutt', 'Affiliation': 'Advanced Centre for Treatment, Research and Education in Cancer, Navi Mumbai, India.'}, {'ForeName': 'Shripad Dinanath', 'Initials': 'SD', 'LastName': 'Banavali', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Prabhash', 'Affiliation': 'Tata Memorial Center, Mumbai, India.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01154']
1896,31474283,Teaching tolerance or acting tolerant? Evaluating skills- and contact-based prejudice reduction interventions among Palestinian-Israeli and Jewish-Israeli youth.,"Although contact-based interventions are the cornerstone of prejudice reduction, in high-conflict environments, incendiary contact with outgroups can instead exacerbate negative attitudes. Supplementing contact interventions with social-cognitive/emotional approaches may, instead, help facilitate positive contact. This study evaluated the effectiveness of two prejudice reduction interventions among 148 Palestinian-Israeli and 154 Jewish-Israeli 5th grade students (M age.years  = 10.55, SD = 0.26) in a high conflict area. Schools in Jaffa, Israel were assigned to a social-cognitive/emotional skills-based intervention, a skills- and contact-based intervention (i.e., skills, skills+contact), or the control group-all delivered as part of the curriculum. Prejudice was assessed through participants' judgments of and justifications about hypothetical scenarios of intergroup exclusion in peer and home contexts at pre-test, post-test, and 6-month follow-up. Repeated measures ANOVAs showed various main effects including gender, ethnicity, and context in which the exclusion occurred (peer/home). Significant higher level interactions with group by time demonstrated the positive influence of both treatment groups on prejudice reduction. The skills and skills+contact groups became more rejecting while the control group became more accepting of exclusion across time. Additionally, the skills and skills+contact groups increased in moral and empathic reasoning over time, whereas the control group increased in social conventional and stereotyped prejudiced reasoning. These findings illustrate the effectiveness of in-school social-cognitive/emotional skills and combined skills+contact approaches in reducing the prejudiced attitudes of Palestinian- and Jewish-Israeli pre-adolescents, especially in areas with protracted conflict.",2019,"Additionally, the skills and skills+contact groups increased in moral and empathic reasoning over time, whereas the control group increased in social conventional and stereotyped prejudiced reasoning.","['Palestinian-Israeli and Jewish-Israeli youth', 'Schools in Jaffa, Israel', '148 Palestinian-Israeli and 154 Jewish-Israeli 5th grade students (M age.years \u202f=\u202f10.55, SD\u202f=\u202f0.26) in a high conflict area']","['social-cognitive/emotional skills-based intervention, a skills- and contact-based intervention (i.e., skills, skills+contact), or the control group-all delivered as part of the curriculum', 'prejudice reduction interventions', 'Evaluating skills- and contact-based prejudice reduction interventions']","['gender, ethnicity, and context in which the exclusion occurred (peer/home', 'moral and empathic reasoning', 'social conventional and stereotyped prejudiced reasoning']","[{'cui': 'C0282539', 'cui_str': 'Palestinians'}, {'cui': 'C0178443', 'cui_str': 'Jewish, follower of religion (person)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0033023', 'cui_str': 'Prejudice'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0449255', 'cui_str': 'Context (attribute)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0026532', 'cui_str': 'Morals'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0038272', 'cui_str': 'Stereotyping'}]",,0.0161339,"Additionally, the skills and skills+contact groups increased in moral and empathic reasoning over time, whereas the control group increased in social conventional and stereotyped prejudiced reasoning.","[{'ForeName': 'Alaina', 'Initials': 'A', 'LastName': 'Brenick', 'Affiliation': 'University of Connecticut, Department of Human Development and Family Sciences, 348 Mansfield Rd., U-1058, Storrs, CT 06269-1058, United States of America. Electronic address: alaina.brenick@uconn.edu.'}, {'ForeName': 'Samantha E', 'Initials': 'SE', 'LastName': 'Lawrence', 'Affiliation': 'University of Connecticut, United States of America.'}, {'ForeName': 'Daniell', 'Initials': 'D', 'LastName': 'Carvalheiro', 'Affiliation': 'University of Connecticut, United States of America.'}, {'ForeName': 'Rony', 'Initials': 'R', 'LastName': 'Berger', 'Affiliation': 'Ben Gurion University of the Negev, Israel.'}]",Journal of school psychology,['10.1016/j.jsp.2019.07.001']
1897,31394525,Randomized Controlled Trial on the Effects of Morning versus Evening Primary Vaccination on Episodes of Hypoxemia and Bradycardia in Very Preterm Infants.,"BACKGROUND


Hypoxemia and bradycardia occur frequently in preterm infants, but are incompletely understood. They are more prevalent during infections and following immunization. Data on adults suggested an increased immune response if subjects slept following vaccination, suggesting an interaction between circadian rhythm and the immune system. Whether this holds true for preterm infants with their less well-established circadian rhythm is unclear.
OBJECTIVE


Do infants born at 26-30 weeks' gestation and having received their first routine hexavalent vaccination in the morning have a lower cardiorespiratory event rate (CER) after vaccination than those receiving it in the evening?
METHODS


Twenty-six infants were randomized to an evening versus morning vaccination group in a pilot and main study with 10 and 16 participants, respectively. Pulse oximeter saturation, actigraphy, and rectal temperature were obtained for 24 h before and after vaccination. Blood samples for vaccination titers were taken before vaccination and during a follow-up examination in our outpatient clinic; another blood sample was taken 24 h after vaccination to determine inflammatory markers.
RESULTS


Vaccination led to an increase in CER in both groups, but there was no difference in CER between the morning and evening groups. Vaccination titers for Bordetella pertussis were increased in both groups, with no difference in inflammatory markers 24 h after vaccination. Body temperature increased in both groups after vaccination. Participants in the evening group slept longer after vaccination.
CONCLUSIONS


We did not identify a difference in CER between morning and evening vaccination but could confirm increased body temperatures and vaccination titers following vaccination.",2019,"Vaccination titers for Bordetella pertussis were increased in both groups, with no difference in inflammatory markers 24 h after vaccination.","['preterm infants with their less well-established circadian rhythm', 'Twenty-six infants', 'Very Preterm Infants', 'preterm infants', ""infants born at 26-30 weeks' gestation and having""]","['Morning versus Evening Primary Vaccination', 'evening versus morning vaccination']","['Episodes of Hypoxemia and Bradycardia', 'Pulse oximeter saturation, actigraphy, and rectal temperature', 'CER', 'cardiorespiratory event rate (CER', 'body temperatures and vaccination titers', 'Vaccination titers', 'immune response', 'Body temperature']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0008810', 'cui_str': 'Nycthemeral Rhythm'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0182109', 'cui_str': 'Pulse oximeter (physical object)'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0489749', 'cui_str': 'Rectal temperature'}, {'cui': 'C0237504', 'cui_str': 'CER (body structure)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}]",24.0,0.20179,"Vaccination titers for Bordetella pertussis were increased in both groups, with no difference in inflammatory markers 24 h after vaccination.","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Gottlob', 'Affiliation': ""Department of Neonatology, University Children's Hospital, Tübingen, Germany.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gille', 'Affiliation': ""Department of Neonatology, University Children's Hospital, Tübingen, Germany.""}, {'ForeName': 'Christian F', 'Initials': 'CF', 'LastName': 'Poets', 'Affiliation': ""Department of Neonatology, University Children's Hospital, Tübingen, Germany, Christian-F.Poets@med.uni-tuebingen.de.""}]",Neonatology,['10.1159/000501338']
1898,31285821,Glycerol content within the WHO ethanol-based handrub formulation: balancing tolerability with antimicrobial efficacy.,"Background


The World Health Organization (WHO) ethanol-based handrub (EBHR) formulation contains 1.45% glycerol as an emollient to protect healthcare workers' (HCWs) skin against dryness and dermatitis. However, glycerol seems to negatively affect the antimicrobial efficacy of alcohols. In addition, the minimal concentration of glycerol required to protect hands remain unknown. We aim to evaluate the tolerance of HCWs to the WHO EBHR formulation using different concentrations of glycerol in a tropical climate healthcare setting.
Methods


We conducted a cluster-randomized, double-blind, crossover study among 40 HCWs from an intensive care unit of a tertiary-care hospital in Brazil ,  from June 1st to September 30, 2017. We tested the WHO EBHR original formulation containing 1.45% glycerol against three other concentrations (0, 0.5, and 0.75%). HCWs used one formulation at a time for seven working days during their routine practice and then had their hands evaluated by an external observer using the WHO scale for visual inspection. Participants also used a WHO self-evaluation tool to rate their own skin condition. We used a generalized estimating equations of the logit type to compare differences between the tolerability to different formulations.
Results


According to the independent observation, participants had 2.4 times (95%CI: 1.12-5.15) more chance of having a skin condition considered good when they used the 0.5% compared to the 1.45% glycerol formulation. For the self-evaluation scale, participants were likely to have a worst evaluation (OR: 0.23, 95%CI: 0.11-0.49) when they used the preparation without glycerol compared to the WHO standard formulation (1.45%), and there were no differences between the other formulations used.
Conclusion


In a tropical climate setting, the WHO-modified EBHR formulation containing 0.5% glycerol led to better ratings of skin tolerance than the original formulation, and, therefore, may offer the best balance between skin tolerance and antimicrobial efficacy.",2019,"For the self-evaluation scale, participants were likely to have a worst evaluation (OR: 0.23, 95%CI: 0.11-0.49) when they used the preparation without glycerol compared to the WHO standard formulation (1.45%), and there were no differences between the other formulations used.
","['40 HCWs from an intensive care unit of a tertiary-care hospital in Brazil ,  from June 1st to September 30, 2017']",['\n\n\nThe World Health Organization (WHO) ethanol-based handrub (EBHR) formulation contains 1.45% glycerol'],"['chance of having a skin condition', 'skin tolerance', 'antimicrobial efficacy of alcohols']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0205435', 'cui_str': 'First (qualifier value)'}]","[{'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0202304', 'cui_str': 'Alcohol measurement (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4517505', 'cui_str': '1.45'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}]","[{'cui': 'C1719933', 'cui_str': 'Skin condition'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]",,0.0494742,"For the self-evaluation scale, participants were likely to have a worst evaluation (OR: 0.23, 95%CI: 0.11-0.49) when they used the preparation without glycerol compared to the WHO standard formulation (1.45%), and there were no differences between the other formulations used.
","[{'ForeName': 'Mayra Gonçalves', 'Initials': 'MG', 'LastName': 'Menegueti', 'Affiliation': '1Infection Control Service, University Hospital of Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Ana Maria', 'Initials': 'AM', 'LastName': 'Laus', 'Affiliation': 'Ribeirão Preto Nursing School, University of São Paul, Ribeirão Preto, Brazil.'}, {'ForeName': 'Márcia Aparecida', 'Initials': 'MA', 'LastName': 'Ciol', 'Affiliation': '3University of Washington, Seattle, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Auxiliadora-Martins', 'Affiliation': '4Intensive Care Division, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Anibal', 'Initials': 'A', 'LastName': 'Basile-Filho', 'Affiliation': '4Intensive Care Division, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Elucir', 'Initials': 'E', 'LastName': 'Gir', 'Affiliation': 'Ribeirão Preto Nursing School, University of São Paul, Ribeirão Preto, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Pires', 'Affiliation': '5Infection Control Programme, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Pittet', 'Affiliation': '5Infection Control Programme, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Bellissimo-Rodrigues', 'Affiliation': '1Infection Control Service, University Hospital of Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil.'}]",Antimicrobial resistance and infection control,['10.1186/s13756-019-0553-z']
1899,32439573,"A commentary on: ""Efficacy of single layered intestinal anastomosis over double layered intestinal anastomosis - an open labelled, randomised control trial"".",,2020,,[],['single layered intestinal anastomosis'],[],[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}]",[],,0.0957589,,"[{'ForeName': 'Alethea', 'Initials': 'A', 'LastName': 'Tang', 'Affiliation': 'Aneurin Bevan University Health Board, Newport, Wales, United Kingdom.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Beamish', 'Affiliation': 'Swansea University Medical School, Swansea University, Swansea, Wales, United Kingdom; Department of Surgical Research and Education, Institute of Clinical Sciences, Gothenburg University, Gothenburg, 41345, Sweden. Electronic address: beamishaj@gmail.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.05.041']
1900,31451913,"Effectiveness of anti-osteoporotic treatment after successful parathyroidectomy for primary hyperparathyroidism: a randomized, double-blind, placebo-controlled trial.","PURPOSE


After successful surgery for primary hyperparathyroidism, bone mineral density (BMD) does not improve equally in all patients. As no trial has so far aimed to influence normalization of BMD, it was the goal of this investigation to determine whether pharmacological treatment is effective in improving regain of BMD after successful parathyroidectomy in patients with preoperatively diagnosed osteoporosis or osteopenia and to evaluate when treatment may be indicated.
METHODS


In this randomized, placebo-controlled, double-blind trial, 52 patients were treated with strontium ranelate 2 g daily + 1000 mg calcium + 800 IU vitamin D (strontium group; SG) or with 1000 mg calcium + 800 IU vitamin D alone (placebo group; PG) for 1 year. The main outcome measures were BMD (lumbar spine, femoral neck, radius) and bone turnover markers.
RESULTS


The baseline characteristics were similar in both groups. Absolute BMD (1.007 ± 0.197 vs. 0.897 ± 0.137 g/cm 2 ; p = 0.024) and both relative (9.94 vs. 3.94%; p < 0.001) and absolute (0.09 ± 0.06 vs. 0.03 ± 0.04 g/cm 2 ; p < 0.001) changes in lumbar-spine BMD were significantly higher in the SG than in the PG. Compared to baseline, BMD significantly increased in both groups at the lumbar spine (p < 0.001 and p = 0.001, respectively) and femoral neck (both p < 0.001), whereas radius BMD only changed significantly in the SG. However, the proportion of patients with osteoporosis/osteopenia significantly declined only at the lumbar spine in the SG (from 69.0 to 37.9%; p = 0.034), whereas no decrease was found in the PG. No severe adverse events occurred.
CONCLUSIONS


Postoperative anti-osteoporotic treatment can positively influence regain of BMD mainly in the lumbar spine and should be considered. Without treatment, most patients and especially those with low preoperative markers of bone turnover remained osteoporotic/osteopenic 1 year after surgery.",2019,p < 0.001) changes in lumbar-spine BMD were significantly higher in the SG than in the PG.,"['primary hyperparathyroidism', 'patients with preoperatively diagnosed osteoporosis or osteopenia', '52 patients']","['anti-osteoporotic treatment', 'placebo', 'calcium\u2009+\u2009800\xa0IU vitamin D alone (placebo group; PG', 'strontium ranelate 2\xa0g daily\u2009+\u20091000\xa0mg calcium\u2009+\u2009800\xa0IU vitamin D (strontium group; SG']","['severe adverse events', 'proportion of patients with osteoporosis/osteopenia', 'BMD (lumbar spine, femoral neck, radius) and bone turnover markers', 'BMD', 'bone mineral density (BMD', 'radius BMD', 'lumbar-spine BMD', 'Absolute BMD', 'femoral neck']","[{'cui': 'C0221002', 'cui_str': 'Hyperparathyroidism, Primary'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0936139', 'cui_str': 'strontium ranelate'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0038467', 'cui_str': 'Strontium'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2721747', 'cui_str': 'Osteoporosis/osteopenia (SMQ)'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C1306504', 'cui_str': 'Radius (qualifier value)'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}]",52.0,0.489899,p < 0.001) changes in lumbar-spine BMD were significantly higher in the SG than in the PG.,"[{'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Niederle', 'Affiliation': 'Department of Surgery, Division of General Surgery, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria. martin.niederle@meduniwien.ac.at.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Foeger-Samwald', 'Affiliation': 'Department of Pathophysiology and Allergy Research, Center for Pathophysiology, Infectiology and Immunology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Riss', 'Affiliation': 'Department of Surgery, Division of General Surgery, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Selberherr', 'Affiliation': 'Department of Surgery, Division of General Surgery, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Scheuba', 'Affiliation': 'Department of Surgery, Division of General Surgery, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Pietschmann', 'Affiliation': 'Department of Pathophysiology and Allergy Research, Center for Pathophysiology, Infectiology and Immunology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Niederle', 'Affiliation': 'Department of Surgery, Division of General Surgery, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Kerschan-Schindl', 'Affiliation': 'Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}]",Langenbeck's archives of surgery,['10.1007/s00423-019-01815-9']
1901,31339826,Sustained Progression-Free Survival Benefit of Rituximab Maintenance in Patients With Follicular Lymphoma: Long-Term Results of the PRIMA Study.,"PURPOSE


The PRIMA study (ClinicalTrials.gov identifier: NCT00140582) established that 2 years of rituximab maintenance after first-line immunochemotherapy significantly improved progression-free survival (PFS) in patients with follicular lymphoma compared with observation. Here, we report the final PFS and overall survival (OS) results from the PRIMA study after 9 years of follow-up and provide a final overview of safety.
METHODS


Patients (> 18 years of age) with previously untreated high-tumor-burden follicular lymphoma were nonrandomly assigned to receive one of three immunochemotherapy induction regimens. Responding patients were randomly assigned (stratified by induction regimen, response to induction treatment, treatment center, and geographic region) 1:1 to receive 2 years of rituximab maintenance (375 mg/m 2 , once every 8 weeks), starting 8 weeks after the last induction treatment, or observation (no additional treatment). All patients in the extended follow-up provided their written informed consent (data cutoff: December 31, 2016).
RESULTS


In total, 1,018 patients completed induction treatment and were randomly assigned to rituximab maintenance (n = 505) or observation (n = 513). Consent for the extended follow-up was provided by 607 patients (59.6%) of 1,018 (rituximab maintenance, n = 309; observation, n = 298). After data cutoff, median PFS was 10.5 years in the rituximab maintenance arm compared with 4.1 years in the observation arm (hazard ratio, 0.61; 95% CI, 0.52 to 0.73;  P  < .001). No OS difference was seen in patients randomly assigned to rituximab maintenance or observation (hazard ratio, 1.04; 95% CI, 0.77 to 1.40;  P  = .7948); 10-year OS estimates were approximately 80% in both study arms. No new safety signals were observed.
CONCLUSION


Rituximab maintenance after induction immunochemotherapy provides a significant long-term PFS, but not OS, benefit over observation.",2019,"No OS difference was seen in patients randomly assigned to rituximab maintenance or observation (hazard ratio, 1.04; 95% CI, 0.77 to 1.40;  P  = .7948); 10-year OS estimates were approximately 80% in both study arms.","['Patients With Follicular Lymphoma', 'Patients (> 18 years of age) with previously untreated high-tumor-burden follicular lymphoma', 'patients with follicular lymphoma compared with observation', '1,018 patients completed induction treatment']","['immunochemotherapy induction regimens', 'rituximab maintenance', 'Rituximab Maintenance']","['10-year OS estimates', 'final PFS and overall survival (OS', 'median PFS', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024301', 'cui_str': 'Brill-Symmers Disease'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1449699', 'cui_str': 'Tumor Burden'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C4087148', 'cui_str': 'Immunochemotherapy'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",1018.0,0.177374,"No OS difference was seen in patients randomly assigned to rituximab maintenance or observation (hazard ratio, 1.04; 95% CI, 0.77 to 1.40;  P  = .7948); 10-year OS estimates were approximately 80% in both study arms.","[{'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Bachy', 'Affiliation': 'Hospices Civils de Lyon, Université Claude Bernard Lyon 1, Institut National de la Santé et de la Recherche Médicale (INSERM) 1052, Pierre-Bénite, France.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Seymour', 'Affiliation': 'Royal Melbourne Hospital and University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Feugier', 'Affiliation': 'Centre Hospitalier Régional Universitaire de Nancy, Université de Lorraine, INSERM 1256, Nancy, France.'}, {'ForeName': 'Fritz', 'Initials': 'F', 'LastName': 'Offner', 'Affiliation': 'Ghent University, Ghent, Belgium.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'López-Guillermo', 'Affiliation': 'Hospital Clinic, Barcelona, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Belada', 'Affiliation': 'Charles University, Hradec Králové, Czech Republic.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Xerri', 'Affiliation': 'Institut Paoli-Calmettes, Aix-Marseille Université, Marseille, France.'}, {'ForeName': 'John V', 'Initials': 'JV', 'LastName': 'Catalano', 'Affiliation': 'Frankston Hospital and Monash University, Frankston, Victoria, Australia.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Brice', 'Affiliation': 'Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lemonnier', 'Affiliation': 'Hôpitaux Universitaires Henri Mondor, Université Paris-Est Créteil, INSERM U955, Créteil, France.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'Hospital Universitario de Salamanca-Institute for Biomedical Research of Salamanca, Centro de Investigación Biomédica en Red de Cáncer, Salamanca, Spain.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Casasnovas', 'Affiliation': 'Department of Haematology and INSERM 1231, University Hospital F. Mitterrand, Dijon, France.'}, {'ForeName': 'Lars M', 'Initials': 'LM', 'LastName': 'Pedersen', 'Affiliation': 'Herlev University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Dorvaux', 'Affiliation': 'Hôpital de Mercy Centre Hospitalier Régional Metz-Thionville, Metz, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Simpson', 'Affiliation': 'North Shore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Sirpa', 'Initials': 'S', 'LastName': 'Leppa', 'Affiliation': 'Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Gabarre', 'Affiliation': 'Hôpital Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'da Silva', 'Affiliation': 'Portuguese Institute of Oncology, Lisbon, Portugal.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Glaisner', 'Affiliation': 'Institut Curie-Hôpital Rene Huguenin, Saint-Cloud, France.'}, {'ForeName': 'Loic', 'Initials': 'L', 'LastName': 'Ysebaert', 'Affiliation': 'Institut Universitaire du Cancer de Toulouse-Oncopole, Toulouse, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Vekhoff', 'Affiliation': 'Saint Antoine Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Tanin', 'Initials': 'T', 'LastName': 'Intragumtornchai', 'Affiliation': 'Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Le Gouill', 'Affiliation': 'Centre Hospitalier Universitaire de Nantes, Centre de Recherche en Cancérologie et Immunologie Nantes Angers, INSERM, Université de Nantes, Nantes, France.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Lister', 'Affiliation': 'Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Estell', 'Affiliation': 'Concord Hospital, Concord, University of Sydney, New South Wales, Australia.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Milone', 'Affiliation': 'Fundaleu, Buenos Aires, Argentina.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Sonet', 'Affiliation': 'UCL, Mont-Godinne, Yvoir, Belgium.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Farhi', 'Affiliation': ""Centre Hospitalier Universitaire d'Angers, Angers, France.""}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Zeuner', 'Affiliation': 'F Hoffman-La Roche, Basel, Switzerland.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Tilly', 'Affiliation': 'Centre Henri-Becquerel, Rouen, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Salles', 'Affiliation': 'Hospices Civils de Lyon, Université Claude Bernard Lyon 1, Institut National de la Santé et de la Recherche Médicale (INSERM) 1052, Pierre-Bénite, France.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01073']
1902,31466479,Internal Versus External Electrical Cardioversion of Atrial Arrhythmia in Patients With Implantable Cardioverter-Defibrillator: A Randomized Clinical Trial.,"BACKGROUND


Atrial arrhythmias are common in patients with implantable cardioverter-defibrillator (ICD). External shocks and internal cardioversion through commanded ICD shock for electrical cardioversion are used for rhythm-control. However, there is a paucity of data on efficacy of external versus internal cardioversion and on the risk of lead and device malfunction. We hypothesized that external cardioversion is noninferior to internal cardioversion for safety, and superior for successful restoration of sinus rhythm.
METHODS


Consecutive patients with ICD undergoing elective cardioversion for atrial arrhythmias at 13 centers were randomized in 1:1 fashion to either internal or external cardioversion. The primary safety end point was a composite of surrogate events of lead or device malfunction. Conversion of atrial arrhythmia to sinus rhythm was the primary efficacy end point. Myocardial damage was studied by measuring troponin release in both groups.
RESULTS


N=230 patients were randomized. Shock efficacy was 93% in the external cardioversion group and 65% in the internal cardioversion group ( P <0.001). Clinically relevant adverse events caused by external or internal cardioversion were not observed. Three cases of pre-existing silent lead malfunction were unmasked by internal shock, resulting in lead failure. Troponin release did not differ between groups.
CONCLUSIONS


This is the first randomized trial on external vs internal cardioversion in patients with ICDs. External cardioversion was superior for the restoration of sinus rhythm. The unmasking of silent lead malfunction in the internal cardioversion group suggests that an internal shock attempt may be reasonable in selected ICD patients presenting for electrical cardioversion.
CLINICAL TRIAL REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT03247738.",2019,Shock efficacy was 93% in the external cardioversion group and 65% in the internal cardioversion group (p<0.001).,"['patients with implantable cardioverterdefibrillator (ICD', 'Consecutive patients with ICD undergoing elective cardioversion for atrial arrhythmias at 13 centers', 'patients with ICDs', 'selected ICD patients presenting for electrical cardioversion', 'Patients with Implantable Cardioverter-Defibrillator', 'N=230 patients were randomized']","['internal or external cardioversion', 'External cardioversion', 'Internal vs. External Electrical Cardioversion of Atrial Arrhythmia', 'external vs. internal cardioversion', 'External shocks and internal cardioversion through commanded ICD shock', 'external cardioversion']","['Shock efficacy', 'composite of surrogate events of lead or device malfunction', 'troponin release', 'Troponin release', 'Myocardial damage']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0013778', 'cui_str': 'Electrical Cardioversion'}, {'cui': 'C0085611', 'cui_str': 'Atrial arrhythmia (disorder)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0162589', 'cui_str': 'Implantable Cardioverter-Defibrillators'}]","[{'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0013778', 'cui_str': 'Electrical Cardioversion'}, {'cui': 'C0085611', 'cui_str': 'Atrial arrhythmia (disorder)'}, {'cui': 'C0419060', 'cui_str': 'Internal electrode cardioversion (procedure)'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}]","[{'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1504465', 'cui_str': 'Device malfunction'}, {'cui': 'C0523952', 'cui_str': 'Troponin measurement'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}]",230.0,0.033156,Shock efficacy was 93% in the external cardioversion group and 65% in the internal cardioversion group (p<0.001).,"[{'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Lüker', 'Affiliation': 'University of Cologne, University Hospital Cologne, Department of Electrophysiology (J.L., A.S., D.S.), Germany.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Kuhr', 'Affiliation': 'Institute of Medical Statistics and Computational Biology (IMSB) (K.K., S.S.), Germany.'}, {'ForeName': 'Arian', 'Initials': 'A', 'LastName': 'Sultan', 'Affiliation': 'University of Cologne, University Hospital Cologne, Department of Electrophysiology (J.L., A.S., D.S.), Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Nölker', 'Affiliation': 'Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Clinic for Electrophysiology, Bad Oeynhausen, Germany (G.N., H.O.).'}, {'ForeName': 'Hazem', 'Initials': 'H', 'LastName': 'Omran', 'Affiliation': 'Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Clinic for Electrophysiology, Bad Oeynhausen, Germany (G.N., H.O.).'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Willems', 'Affiliation': 'Department of Electrophysiology, University Heart Center, Hamburg, Germany (S.W.).'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Andrié', 'Affiliation': 'Department of Internal Medicine II, University Hospital Bonn, Germany (R.A., J.W.S.).'}, {'ForeName': 'Jan W', 'Initials': 'JW', 'LastName': 'Schrickel', 'Affiliation': 'Department of Internal Medicine II, University Hospital Bonn, Germany (R.A., J.W.S.).'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Winter', 'Affiliation': 'St. Vinzenz Hospital, Cologne, Germany (S.W.).'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Vollmann', 'Affiliation': 'Herz- & Gefäßzentrum Göttingen, Germany (D.V.).'}, {'ForeName': 'Roland R', 'Initials': 'RR', 'LastName': 'Tilz', 'Affiliation': 'Department of Cardiology, University Hospital Lübeck, Germany (R.R.T., A.J., C.H.H.).'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Jobs', 'Affiliation': 'Department of Cardiology, University Hospital Lübeck, Germany (R.R.T., A.J., C.H.H.).'}, {'ForeName': 'Christian-H', 'Initials': 'CH', 'LastName': 'Heeger', 'Affiliation': 'Department of Cardiology, University Hospital Lübeck, Germany (R.R.T., A.J., C.H.H.).'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Metzner', 'Affiliation': 'Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany (A.M.).'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Meyer', 'Affiliation': 'Department of Cardiology, Heart Center Oldenburg, European Medical School Oldenburg-Groningen, Germany (S.M.).'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Mischke', 'Affiliation': 'Medical Clinic I, Leopoldina Hospital, Schweinfurt, Germany (K.M.).'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Napp', 'Affiliation': 'Department of Internal Medicine I, RWTH Aachen University Hospital, Germany (A.N.).'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Fahrig', 'Affiliation': 'Klinikum Leverkusen, Germany (A.F.).'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Steinhauser', 'Affiliation': 'Institute of Medical Statistics and Computational Biology (IMSB) (K.K., S.S.), Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Brachmann', 'Affiliation': 'Medical Clinic II, Coburg Hospital, Germany (J.B.).'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Baldus', 'Affiliation': 'Department of Cardiology (S.B.), Germany.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Mahajan', 'Affiliation': 'Center for Heart Rhythm Disorders, South Australian Health and Medical Research Institute (SAHMRI), University of Adelaide, Australia (R.M., P.S.).'}, {'ForeName': 'Prashanthan', 'Initials': 'P', 'LastName': 'Sanders', 'Affiliation': 'Center for Heart Rhythm Disorders, South Australian Health and Medical Research Institute (SAHMRI), University of Adelaide, Australia (R.M., P.S.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Steven', 'Affiliation': 'University of Cologne, University Hospital Cologne, Department of Electrophysiology (J.L., A.S., D.S.), Germany.'}]",Circulation,['10.1161/CIRCULATIONAHA.119.041320']
1903,31461146,"Effect of Prices, Distribution Strategies, and Marketing on Demand for HIV Self-testing in Zimbabwe: A Randomized Clinical Trial.","Importance


HIV self-testing is a promising approach for increasing awareness of HIV status in sub-Saharan Africa, particularly in Zimbabwe, where HIV prevalence is 13%. Evidence is lacking, however, on the optimal pricing policies and delivery strategies for maximizing the effect of HIV self-testing.
Objective


To assess demand for HIV self-testing among adults and priority-population subgroups under alternative pricing and distribution strategies.
Design, Setting, and Participants


This randomized clinical trial recruited study participants between February 15, 2018, and April 25, 2018, in urban and rural communities in Zimbabwe. A factorial design was used to randomize participants to a combination of self-test price, distribution site, and promotional message. Individuals and their household members had to be at least 16 years old to be eligible for participation. This intention-to-treat population comprised 3996 participants.
Interventions


Participants were given a voucher that could be redeemed for an HIV self-test within 1 month at varying prices (US $0-$3) and distribution sites (clinics or pharmacies in urban areas, and retail stores or community health workers in rural areas). Vouchers included randomly assigned promotional messages that emphasized the benefits of HIV testing.
Main Outcomes and Measures


Proportion of participants who obtained self-tests in each trial arm, measured by distributor records.
Results


Among the 4000 individuals enrolled, 3996 participants were included. In total, the mean (SD) age was 35 (14.7) years, and most participants (2841 [71.1%]) were female. Self-testing demand was highly price sensitive; 260 participants (32.5%) who were offered free self-tests redeemed their vouchers, compared with 55 participants (6.9%) who were offered self-tests for US $0.50 (odds ratio [OR], 0.14; 95% CI, 0.10-0.19), a reduction in demand of more than 25 percentage points. Demand was below 3% in the $1, $2, and $3 groups, which was statistically significantly lower than the demand in the free distribution group: in pooled analyses, demand was considerably lower among participants in higher-than-$0 price groups compared with the free distribution group (2.8% vs 32.5%; OR, 0.05; 95% CI, 0.04-0.07). In urban areas, demand was statistically significantly higher with pharmacy-based distribution compared with clinic-based distribution (6.8% vs 2.9%; adjusted OR, 2.78; 95% CI, 1.74-4.45). Price sensitivity was statistically significantly higher among rural residents, men, and those who had never received testing before. Promotional messages did not influence demand.
Conclusions and Relevance


This study found that demand for HIV self-testing in Zimbabwe was highly price sensitive, suggesting that free distribution may be essential for promoting testing among high-priority population groups; additionally, pharmacy-based distribution was preferable to clinic-based distribution in urban areas.
Trial Registration


ClinicalTrials.gov identifier: NCT03559959.",2019,"Demand was below 3% in the $1, $2, and $3 groups, which was statistically significantly lower than the demand in the free distribution group: in pooled analyses, demand was considerably lower among participants in higher-than-$0 price groups compared with the free distribution group (2.8% vs 32.5%; OR, 0.05; 95% CI, 0.04-0.07).","['Zimbabwe', 'participants between February 15, 2018, and April 25, 2018, in urban and rural communities in Zimbabwe', 'In total, the mean (SD) age was 35 (14.7) years, and most participants (2841 [71.1%]) were female', '4000 individuals enrolled, 3996 participants were included', 'adults and priority-population subgroups under alternative pricing and distribution strategies', 'Individuals and their household members had to be at least 16 years old to be eligible for participation', '3996 participants']","['voucher that could be redeemed for an HIV self-test within 1 month at varying prices (US $0-$3) and distribution sites (clinics or pharmacies in urban areas, and retail stores or community health workers in rural areas']",['Price sensitivity'],"[{'cui': 'C0043476', 'cui_str': 'Southern Rhodesia'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0165079', 'cui_str': 'IS 35'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C3842327', 'cui_str': '4000 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4517755', 'cui_str': 'Three thousand nine hundred and ninety-six'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549179', 'cui_str': 'Priority (attribute)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0033118', 'cui_str': 'Pricing'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0080045', 'cui_str': 'Prices'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0031322', 'cui_str': 'Pharmacies'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}]","[{'cui': 'C0080045', 'cui_str': 'Prices'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}]",260.0,0.0943958,"Demand was below 3% in the $1, $2, and $3 groups, which was statistically significantly lower than the demand in the free distribution group: in pooled analyses, demand was considerably lower among participants in higher-than-$0 price groups compared with the free distribution group (2.8% vs 32.5%; OR, 0.05; 95% CI, 0.04-0.07).","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chang', 'Affiliation': 'Department of Health Policy and Management, University of North Carolina at Chapel Hill, Chapel Hill.'}, {'ForeName': 'Primrose', 'Initials': 'P', 'LastName': 'Matambanadzo', 'Affiliation': 'CeSHHAR Zimbabwe, Avondale, Harare, Zimbabwe.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Takaruza', 'Affiliation': 'CeSHHAR Zimbabwe, Avondale, Harare, Zimbabwe.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Hatzold', 'Affiliation': 'Population Services International, Washington, DC.'}, {'ForeName': 'Frances M', 'Initials': 'FM', 'LastName': 'Cowan', 'Affiliation': 'CeSHHAR Zimbabwe, Avondale, Harare, Zimbabwe.'}, {'ForeName': 'Euphemia', 'Initials': 'E', 'LastName': 'Sibanda', 'Affiliation': 'CeSHHAR Zimbabwe, Avondale, Harare, Zimbabwe.'}, {'ForeName': 'Harsha', 'Initials': 'H', 'LastName': 'Thirumurthy', 'Affiliation': 'Division of Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.9818']
1904,32087143,Withdrawn: Reduced Risk of Recurrence of Noninfectious Posterior Segment Uveitis After 0.18-mg Fluocinolone Acetonide Insert: Randomized Trial.,,2020,"RESULTS


Uveitis recurrence rates were significantly lower in FAi group compared to sham at 6 (18.4 vs 78.6%; p<0.001) and 12 months (27.6 vs 85.7%; p<0.001).","['Eligible patients', 'chronic non-infectious uveitis affecting the posterior segment of the eye']","['fluocinolone acetonide intravitreal (FAi', 'fluocinolone acetonide', 'FAi']","['risk of recurrence of non-infectious posterior segment uveitis', 'recurrence within 12 months, resolution of macular edema, change in best corrected visual acuity, intraocular pressure (IOP) and adverse events', 'IOP rise of ≥12 mmHg', 'IOP-lowering medication', 'safety and efficacy', 'resolution of macular edema', 'recurrence of uveitis', 'likelihood of uveitis flares', 'Uveitis recurrence rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0348015', 'cui_str': 'Posterior segment (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C0016298', 'cui_str': 'Fluocinolone Acetonide'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0348015', 'cui_str': 'Posterior segment (qualifier value)'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0271051', 'cui_str': 'Macular Edema'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.377415,"RESULTS


Uveitis recurrence rates were significantly lower in FAi group compared to sham at 6 (18.4 vs 78.6%; p<0.001) and 12 months (27.6 vs 85.7%; p<0.001).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Callanan', 'Affiliation': 'Texas Retina Associates, Arlington, Texas, USA; University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Quan Dong', 'Initials': 'QD', 'LastName': 'Nguyen', 'Affiliation': 'Byers Eye Institute, Stanford University, Palo Alto, California, USA.'}, {'ForeName': 'Eric B', 'Initials': 'EB', 'LastName': 'Suhler', 'Affiliation': 'Department of Ophthalmology, Oregon Health and Science University, Portland, Oregon, USA; Department of Public Health, Oregon Health and Science University-Portland State University School of Public Health, Portland, Oregon, USA; Ophthalmology Service, Veterans Affairs Portland Health Care System, Portland, Oregon, USA.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Paggiarino', 'Affiliation': 'EyePoint Pharmaceuticals, Inc, Watertown, Massachusetts, USA.'}, {'ForeName': 'Gerard E', 'Initials': 'GE', 'LastName': 'Riedel', 'Affiliation': 'EyePoint Pharmaceuticals, Inc, Watertown, Massachusetts, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of ophthalmology,['10.1016/j.ajo.2020.02.011']
1905,31787506,Apremilast mechanism of efficacy in systemic-naive patients with moderate plaque psoriasis: Pharmacodynamic results from the UNVEIL study.,"BACKGROUND


Pharmacodynamic (PD) subanalyses of clinical trials in patients with moderate to severe psoriasis demonstrated the efficacy of apremilast correlated with reductions in cytokines involved in the pathogenesis of psoriasis.
OBJECTIVE


This PD subanalysis of a phase IV, randomized, controlled trial (UNVEIL) in systemic-naive patients with moderate plaque psoriasis (psoriasis-involved body surface area [BSA] 5%-10%; static Physician's Global Assessment [sPGA] = 3) evaluated the relationship between efficacy and changes in inflammatory biomarkers with apremilast 30 mg twice daily (BID) versus placebo.
METHODS


Patients were randomized (2:1) to apremilast 30 mg BID or placebo for 16 weeks. Blood samples were analyzed for interleukins (IL)-17A, -17F, -22, and -23; cardiometabolic biomarkers (leptin; adiponectin; apolipoproteins A-I, A-II, B, and E); and the number of T-helper 17 (Th17) cells, regulatory T cells, and total T cells at Weeks 0, 4, and 16. Correlations were examined between percentage change in biomarkers and efficacy (based on PGAxBSA).
RESULTS


Of 221 randomized patients, 38 were included in PD analyses (placebo, n = 12; apremilast, n = 26). Median percentage reductions in plasma cytokine levels were significantly greater with apremilast versus placebo for IL-17A (P < 0.05), IL -17F (P < 0.001), and IL-22 (P < 0.01) at Week 4 and IL-22 (P < 0.05) at Week 16. At Week 16, in patients receiving apremilast, improvement in PGAxBSA significantly correlated with change in IL-17A (r = 0.45, P = 0.04). Adipokines, apolipoproteins, and T-cell population levels were largely unchanged.
CONCLUSION


Clinical improvements in psoriasis correlated with apremilast-mediated decreases in IL-17A without significantly affecting systemic IL-23 levels, adipokines, or Th17 and regulatory T-cell numbers.",2019,"Median percentage reductions in plasma cytokine levels were significantly greater with apremilast versus placebo for IL-17A (P < 0.05), IL -17F (","['Patients', 'systemic-naive patients with moderate plaque psoriasis (psoriasis-involved body surface area [BSA] 5%-10', 'patients with moderate to severe psoriasis', 'systemic-naive patients with moderate plaque psoriasis', '221 randomized patients']",['placebo'],"['IL-17A', 'Adipokines, apolipoproteins, and T-cell population levels', 'IL -17F ', 'IL-22', 'plasma cytokine levels', 'cardiometabolic biomarkers (leptin; adiponectin; apolipoproteins A-I, A-II, B, and E); and the number of T-helper 17 (Th17) cells, regulatory T cells, and total T cells']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1705947', 'cui_str': 'CTLA8'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1705097', 'cui_str': 'Interleukin-17F'}, {'cui': 'C0961814', 'cui_str': 'interleukin-22'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0622790', 'cui_str': 'Apo A-I (Giessen)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C2936411', 'cui_str': 'T Helper 17 Cells'}, {'cui': 'C0039198', 'cui_str': 'T-Cells, Regulatory'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",221.0,0.213481,"Median percentage reductions in plasma cytokine levels were significantly greater with apremilast versus placebo for IL-17A (P < 0.05), IL -17F (","[{'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Strober', 'Affiliation': 'Yale University, New Haven, CT, USA; Central Connecticut Dermatology, Cromwell, CT, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Alikhan', 'Affiliation': 'University of Cincinnati Medical Center, Health Dermatology, Cincinnati, OH, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Lockshin', 'Affiliation': 'DermAssociates, Silver Spring, MD, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Shi', 'Affiliation': 'Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Cirulli', 'Affiliation': 'Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schafer', 'Affiliation': 'Celgene Corporation, Summit, NJ, USA. Electronic address: pschafer@celgene.com.'}]",Journal of dermatological science,['10.1016/j.jdermsci.2019.09.003']
1906,31356921,Oral Janus kinase/SYK inhibition (ASN002) suppresses inflammation and improves epidermal barrier markers in patients with atopic dermatitis.,"BACKGROUND


Moderate-to-severe atopic dermatitis (AD) has been associated with significant disease burden and systemic abnormalities and often requires systemic treatments. Currently, safe and effective oral systemic treatments for moderate-to-severe AD are not yet available. ASN002 is an oral inhibitor of the Janus kinase/spleen tyrosine kinase signaling pathways, targeting several cytokine axes (T H 2/T H 22/T H 17/T H 1) and epidermal differentiation.
OBJECTIVE


We sought to evaluate the effect of ASN002 on the cellular and molecular biomarker profile of patients with moderate-to-severe AD and to correlate changes in biomarkers to improvements in clinical severity measures and pruritus.
METHODS


Thirty-six patients with moderate-to-severe AD were randomized to groups with dose escalation of ASN002 (20, 40, and 80 mg) and a placebo group. Skin biopsy specimens were performed at baseline, day 15, and day 29. Gene expression studies were conducted by using microarray and quantitative RT-PCR, and cellular infiltrates and protein expression were studied by using immunohistochemistry.
RESULTS


ASN002 reversed the lesional skin transcriptome toward a nonlesional phenotype. It also rapidly and significantly suppressed key inflammatory pathways implicated in AD pathogenesis, including T H 2 (IL4 receptor [IL4R], IL13, CCL13/monocyte chemoattractant protein 4, CCL17/thymus and activation-regulated chemokine, CCL18/pulmonary and activation-regulated chemokine, CCL22/macrophage-derived chemokine, and CCL26/eotaxin-3), T H 17/T H 22 (lipocalins, PI3/elafin, CCL20, S100A7/S100A8/S100A9, and IL36G/IL36RN), and T H 1 (IFNG, CXCL9/CXCL11, and MX1) axes and barrier-related measures (filaggrin [FLG] and CLDN23). Significant improvements in AD gene signatures were observed predominantly in the 40- and 80-mg groups. Smaller and largely nonsignificant molecular changes were seen in the 20-mg and placebo groups.
CONCLUSION


The Janus kinase/spleen tyrosine kinase inhibitor ASN002 significantly suppressed key AD inflammatory pathways, corresponding to clinical response. ASN002 might be an effective novel therapeutic agent for moderate-to-severe AD.",2019,"It also rapidly and significantly suppressed key inflammatory pathways implicated in AD pathogenesis, including T H 2 (IL4 receptor [IL4R], IL13, CCL13/monocyte chemoattractant protein 4, CCL17/thymus and activation-regulated chemokine, CCL18/pulmonary and activation-regulated chemokine, CCL22/macrophage-derived chemokine, and CCL26/eotaxin-3), T H 17/T H 22 (lipocalins, PI3/elafin, CCL20, S100A7/S100A8/S100A9, and IL36G/","['Thirty-six patients with moderate-to-severe AD', 'patients with moderate-to-severe AD', 'patients with atopic dermatitis']","['Oral Janus kinase/SYK inhibition (ASN002', 'ASN002', 'placebo']","['IL36RN), and T H 1 (IFNG, CXCL9/CXCL11, and MX1) axes and barrier-related measures', 'AD gene signatures', 'T H 2 (IL4 receptor [IL4R], IL13, CCL13/monocyte chemoattractant protein 4, CCL17/thymus and activation-regulated chemokine, CCL18/pulmonary and activation-regulated chemokine, CCL22/macrophage-derived chemokine, and CCL26/eotaxin-3), T H 17/T H 22 (lipocalins, PI3/elafin, CCL20, S100A7/S100A8/S100A9, and IL36G', 'lesional skin transcriptome', 'epidermal barrier markers']","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0597721', 'cui_str': 'JAK Kinases'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0123771', 'cui_str': 'Receptors, IL-4'}, {'cui': 'C0214743', 'cui_str': 'IL13'}, {'cui': 'C0282566', 'cui_str': 'Monocyte Chemotactic Proteins'}, {'cui': 'C1959608', 'cui_str': 'TARC Chemokine'}, {'cui': 'C4319742', 'cui_str': 'Macrophage Inflammatory Protein 4'}, {'cui': 'C1098076', 'cui_str': 'Macrophage-Derived Chemokine'}, {'cui': 'C4476471', 'cui_str': 'Chemokine CCL26'}, {'cui': 'C1956074', 'cui_str': 'Lipocalins'}, {'cui': 'C1579194', 'cui_str': 'Protease Inhibitor WAP3'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C3178810', 'cui_str': 'Transcriptome'}]",36.0,0.0336823,"It also rapidly and significantly suppressed key inflammatory pathways implicated in AD pathogenesis, including T H 2 (IL4 receptor [IL4R], IL13, CCL13/monocyte chemoattractant protein 4, CCL17/thymus and activation-regulated chemokine, CCL18/pulmonary and activation-regulated chemokine, CCL22/macrophage-derived chemokine, and CCL26/eotaxin-3), T H 17/T H 22 (lipocalins, PI3/elafin, CCL20, S100A7/S100A8/S100A9, and IL36G/","[{'ForeName': 'Ana B', 'Initials': 'AB', 'LastName': 'Pavel', 'Affiliation': 'Department of Dermatology, Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Song', 'Affiliation': 'Department of Dermatology, Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Hyun-Je', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Del Duca', 'Affiliation': 'Department of Dermatology, Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Krueger', 'Affiliation': 'Laboratory for Investigative Dermatology, Rockefeller University, New York, NY.'}, {'ForeName': 'Celina', 'Initials': 'C', 'LastName': 'Dubin', 'Affiliation': 'Department of Dermatology, Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': 'Department of Dermatology, Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Dermatology, Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Department of Dermatology, Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Yeriel D', 'Initials': 'YD', 'LastName': 'Estrada', 'Affiliation': 'Department of Dermatology, Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Denis', 'Affiliation': 'Asana Biosciences, Princeton, NJ.'}, {'ForeName': 'Niranjan', 'Initials': 'N', 'LastName': 'Rao', 'Affiliation': 'Asana Biosciences, Princeton, NJ.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Asana Biosciences, Princeton, NJ.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Zammit', 'Affiliation': 'Asana Biosciences, Princeton, NJ.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bissonnette', 'Affiliation': 'Innovaderm Research, Montreal, Quebec, Canada.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Guttman-Yassky', 'Affiliation': 'Department of Dermatology, Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: emma.guttman@mountsinai.org.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.07.013']
1907,31469675,Mitomycin C-augmented Phacotrabeculectomy Versus Phacoemulsification in Primary Angle-closure Glaucoma: A Randomized Controlled Study.,"PRECIS


Phacotrabeculectomy yielded similar results to phacoemulsification in primary angle-closure glaucoma (PACG) in terms of intraocular pressure (IOP) lowering, glaucoma medications and success rates. Although releasable sutures may have reduced the risk of hypotony; complications and interventions were more common with phacotrabeculectomy.
PURPOSE


To compare the efficacy and safety of phacotrabeculectomy using releasable sutures and adjunctive mitomycin C versus phacoemulsification alone in the management of PACG.
PATIENTS AND METHODS


In total, 63 eyes of 63 PACG patients were randomized to undergo either mitomycin C-augmented phacotrabeculectomy with tight scleral flap closure using releasable sutures aiming at no flow or phacoemulsification alone. The primary outcomes were success rates and complications. Secondary outcomes were IOP and glaucoma medications.
RESULTS


The IOP and glaucoma medications were significantly reduced at 1, 3, 6, and 12 months postoperatively in both groups (P<0.001). There was no statistically significant difference in IOP, IOP reduction, success rates, or survival times between both groups. Glaucoma medications were only significantly lower in the phacotrabeculectomy group at 1 and 3 months. The rates of postoperative interventions and complications were higher in the phacotrabeculectomy group. Complete success, defined as an IOP of 6 to 21 mm Hg on no medications and with no signs of glaucoma progression, was achieved in 58% in the phacotrabeculectomy group, compared with 62% in the phacoemulsification group (P=0.9). Only 2 eyes (6%) in the phacoemulsification group required a subsequent trabeculectomy.
CONCLUSIONS


Trabeculectomy did not seem to add an advantage when combined with phacoemulsification in PACG patients and was associated with more postoperative interventions. Despite the use of releasable sutures to allow titration of the IOP postoperatively, the rate of hypotony and other complications was higher in the phacotrabeculectomy group.",2019,"PRECIS


Phacotrabeculectomy yielded similar results to phacoemulsification in primary angle-closure glaucoma (PACG) in terms of intraocular pressure (IOP) lowering, glaucoma medications and success rates.","['Primary Angle-closure Glaucoma', 'In total, 63 eyes of 63 PACG patients']","['phacotrabeculectomy using releasable sutures and adjunctive mitomycin C versus phacoemulsification alone', 'Mitomycin C-augmented Phacotrabeculectomy Versus Phacoemulsification', 'mitomycin C-augmented phacotrabeculectomy with tight scleral flap closure using releasable sutures aiming at no flow or phacoemulsification alone']","['rates of postoperative interventions and complications', 'Complete success', 'intraocular pressure (IOP) lowering, glaucoma medications and success rates', 'Glaucoma medications', 'rate of hypotony and other complications', 'success rates and complications', 'IOP, IOP reduction, success rates, or survival times', 'efficacy and safety', 'glaucoma progression', 'IOP and glaucoma medications']","[{'cui': 'C0017606', 'cui_str': 'Primary angle-closure glaucoma (disorder)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1167708', 'cui_str': 'Phacotrabeculectomy'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0453911', 'cui_str': 'Tights (physical object)'}, {'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",,0.14059,"PRECIS


Phacotrabeculectomy yielded similar results to phacoemulsification in primary angle-closure glaucoma (PACG) in terms of intraocular pressure (IOP) lowering, glaucoma medications and success rates.","[{'ForeName': 'Yasmine M', 'Initials': 'YM', 'LastName': 'El Sayed', 'Affiliation': 'Department of Ophthalmology, Kasr Al-Ainy School of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Abdelrahman M', 'Initials': 'AM', 'LastName': 'Elhusseiny', 'Affiliation': ''}, {'ForeName': 'Ahmed S', 'Initials': 'AS', 'LastName': 'Albalkini', 'Affiliation': ''}, {'ForeName': 'Reem H', 'Initials': 'RH', 'LastName': 'El Sheikh', 'Affiliation': ''}, {'ForeName': 'Mona A', 'Initials': 'MA', 'LastName': 'Osman', 'Affiliation': ''}]",Journal of glaucoma,['10.1097/IJG.0000000000001345']
1908,31354055,Magnetic Resonance Imaging Pilot Study of Intravenous Glyburide in Traumatic Brain Injury.,"Pre-clinical studies of traumatic brain injury (TBI) show that glyburide reduces edema and hemorrhagic progression of contusions. We conducted a small Phase II, three-institution, randomized placebo-controlled trial of subjects with TBI to assess the safety and efficacy of intravenous (IV) glyburide. Twenty-eight subjects were randomized and underwent a 72-h infusion of IV glyburide or placebo, beginning within 10 h of trauma. Of the 28 subjects, 25 had Glasgow Coma Scale (GCS) scores of 6-10, and 14 had contusions. There were no differences in adverse events (AEs) or severe adverse events (ASEs) between groups. The magnetic resonance imaging (MRI) percent change at 72-168 h from screening/baseline was compared between the glyburide and placebo groups. Analysis of contusions (7 per group) showed that lesion volumes (hemorrhage plus edema) increased 1036% with placebo versus 136% with glyburide ( p  = 0.15), and that hemorrhage volumes increased 11.6% with placebo but decreased 29.6% with glyburide ( p  = 0.62). Three diffusion MRI measures of edema were quantified: mean diffusivity (MD), free water (FW), and tissue MD (MDt), corresponding to overall, extracellular, and intracellular water, respectively. The percent change with time for each measure was compared in lesions ( n  = 14) versus uninjured white matter ( n  = 24) in subjects receiving placebo ( n  = 20) or glyburide ( n  = 18). For placebo, the percent change in lesions for all three measures was significantly different compared with uninjured white matter (analysis of variance [ANOVA],  p  < 0.02), consistent with worsening of edema in untreated contusions. In contrast, for glyburide, the percent change in lesions for all three measures was not significantly different compared with uninjured white matter. Further study of IV glyburide in contusion TBI is warranted.",2020,There were no differences in adverse events (AEs) or severe adverse events (ASEs) between groups.,"['Traumatic Brain Injury', 'subjects with TBI', 'Twenty-eight subjects']","['glyburide or placebo', 'glyburide', 'intravenous (IV) glyburide', 'placebo', 'Intravenous Glyburide', 'glyburide and placebo']","['adverse events (AEs) or severe adverse events (ASEs', 'lesion volumes (hemorrhage plus edema', 'hemorrhage volumes', 'mean diffusivity (MD), free water (FW), and tissue MD (MDt), corresponding to overall, extracellular, and intracellular water, respectively', 'Glasgow Coma Scale (GCS) scores', 'worsening of edema', 'safety and efficacy']","[{'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C4283787', 'cui_str': '28'}]","[{'cui': 'C0017628', 'cui_str': 'glibenclamide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0521119', 'cui_str': 'Extracellular (qualifier value)'}, {'cui': 'C0178719', 'cui_str': 'Intracellular (qualifier value)'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",28.0,0.435742,There were no differences in adverse events (AEs) or severe adverse events (ASEs) between groups.,"[{'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Eisenberg', 'Affiliation': 'Department of Neurosurgery, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Martha E', 'Initials': 'ME', 'LastName': 'Shenton', 'Affiliation': ""Departments of Psychiatry and Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Ofer', 'Initials': 'O', 'LastName': 'Pasternak', 'Affiliation': ""Departments of Psychiatry and Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'J Marc', 'Initials': 'JM', 'LastName': 'Simard', 'Affiliation': 'Department of Neurosurgery, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Okonkwo', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Aldrich', 'Affiliation': 'Department of Neurosurgery, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'He', 'Affiliation': 'Department of Family Medicine and Public Health, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Department of Family Medicine and Public Health, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Erik G', 'Initials': 'EG', 'LastName': 'Hayman', 'Affiliation': 'Department of Neurosurgery, University of Maryland School of Medicine, Baltimore, Maryland.'}]",Journal of neurotrauma,['10.1089/neu.2019.6538']
1909,32441302,Comparison of ultrasound-guided supraclavicular and costoclavicular brachial plexus block using a modified double-injection technique: a randomized non-inferiority trial.,"Ultrasound-guided costoclavicular block (CC-approach) is a recently described brachial plexus block (BPB) and an alternative approach to the supraclavicular approach (SC-approach). The relevant sonoanatomy is analogous in terms of the brachial plexus and its adjacent artery for both approaches. In the present study, we hypothesized that the two approaches will result in similar block dynamics when used the modified double-injection (MDI) technique. One hundred and twelve patients were randomly allocated to receive either a SC- or CC-approach with MDI technique. In the CC group, half the volume was injected adjacent to the medial cord of the brachial plexus, the procedure was guided by ultrasound and verified by nerve stimulator, subsequently the second half was injected close to the lateral cord. In the SC group, the MDI technique was carried out as described in our previous study. Sensory and motor blockade of all four terminal nerves were assessed with a 3-point scale. The primary outcome was the proportion of complete sensory blockade at 15 min with a predefined non-inferiority margin of -13%. The proportion of subjects at 15 min was comparable between the SC group and the CC group (91 vs 87%, absolute difference: -3%). No significant differences were found for complete motor blockade and onset times of the individual nerves within 30 min, and block-related serious adverse events (all P>0.05). We conclude that the MDI technique applied to a costoclavicular and supraclavicular block resulted in similar block dynamics. In addition, it may provide a promising alternative technique when considering the use of multipoint injection.",2020,"No significant differences were found for complete motor blockade and onset times of the individual nerves within 30 min, and block-related serious adverse events (all P>0.05).",['112 patients'],"['SC- or CC-approach with MDI technique', 'ultrasound-guided supraclavicular and costoclavicular brachial plexus block using a modified double-injection technique', 'Ultrasound-guided costoclavicular block (CC-approach']","['proportion of complete sensory blockade', 'complete motor blockade and onset times of the individual nerves within 30 min, and block-related serious adverse events']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C2960425', 'cui_str': 'Injection technique'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0589496', 'cui_str': 'Supraclavicular approach'}, {'cui': 'C0394697', 'cui_str': 'Injection of anesthetic agent into brachial plexus'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",112.0,0.0308918,"No significant differences were found for complete motor blockade and onset times of the individual nerves within 30 min, and block-related serious adverse events (all P>0.05).","[{'ForeName': 'Quehua', 'Initials': 'Q', 'LastName': 'Luo', 'Affiliation': 'The Second School of Clinical Medicine, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Weifeng', 'Initials': 'W', 'LastName': 'Yao', 'Affiliation': 'Department of Anesthesiology, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Yunfei', 'Initials': 'Y', 'LastName': 'Chai', 'Affiliation': ""Department of Anesthesiology, Cardiovascular Institute of Guangdong Province, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China.""}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Chang', 'Affiliation': 'Department of Anesthesiology, Guangdong Second Provincial General Hospital, Guangzhou, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Yao', 'Affiliation': 'Department of Anesthesiology, Guangdong Second Provincial General Hospital, Guangzhou, China.'}, {'ForeName': 'Jiani', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'Department of Anesthesiology, Guangdong Second Provincial General Hospital, Guangzhou, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Hao', 'Affiliation': 'Department of Anesthesiology, Guangdong Second Provincial General Hospital, Guangzhou, China.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Guo', 'Affiliation': 'Department of Anesthesiology, Guangdong Second Provincial General Hospital, Guangzhou, China.'}, {'ForeName': 'HaiHua', 'Initials': 'H', 'LastName': 'Shu', 'Affiliation': 'The Second School of Clinical Medicine, Southern Medical University, Guangzhou, China.'}]",Bioscience reports,['10.1042/BSR20200084']
1910,32441353,Traumatic injury results in prolonged circulation of ultralarge von Willebrand factor and a reduction in ADAMTS13 activity.,"BACKGROUND


Increases in plasma von Willebrand Factor (VWF) levels, accompanied by decreases in the metalloprotease ADAMTS13, have been demonstrated soon after traumatic injury while downstream effects remain unclear.
STUDY DESIGN AND METHODS


A cohort of 37 injured trauma patients from a randomized control trial investigating the use of prehospital plasma transfusion were analyzed for activity and antigen levels of ADAMTS13 and VWF at 0 and 24 hours after admission. Relevant clinical data were abstracted from the medical records. Trauma patient plasma was analyzed via agarose gel electrophoresis to evaluate the effects of injury on VWF multimer composition compared to healthy controls.
RESULTS


von Willebrand factor levels were elevated at presentation (189% [110%-263%] vs. 95% [74%-120%]), persisting through 24 hours (213% [146%-257%] vs. 132% [57%-160%]), compared to healthy controls. Ultralarge VWF (UL-VWF) forms were elevated in trauma patients at both 0 and 24 hours, when compared to pooled normal plasma (10.0% [8.9%-14.3%] and 11.3% [9.1%-21.2%], respectively, vs. 0.6%). Circulating plasma ADAMTS13 activity was decreased at 0 hours (66% [47%-86%] vs. 100% [98%-100%]) and at 24 hours (72.5% [56%-87.3%] vs. 103% [103%-103%]) in trauma patients. ADAMTS13 activity independently predicted the development of coagulopathy and correlated with international normalized ratio, thromboelastography values, injury severity, and blood product transfusion.
CONCLUSION


Traumatic injury is associated with acute coagulopathy that is characterized by increased UL-VWF multimers and reduction in ADAMTS13, which correlates with blood loss, transfusion requirement, and injury severity. These findings suggest the potential for future trials targeting ADAMTS13 repletion to enhance clearance of VWF multimers.",2020,"Ultralarge VWF (UL-VWF) forms were elevated in trauma patients at both 0 and 24 hours, when compared to pooled normal plasma (10.0% [8.9%-14.3%] and 11.3% [9.1%-21.2%], respectively, vs. 0.6%).",['A cohort of 37 injured trauma patients'],[],"['Circulating plasma ADAMTS13 activity', 'international normalized ratio, thromboelastography values, injury severity, and blood product transfusion', 'activity and antigen levels of ADAMTS13 and VWF', 'von Willebrand factor levels', 'plasma von Willebrand Factor (VWF) levels', 'Ultralarge VWF (UL-VWF']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C0040017', 'cui_str': 'Thromboelastography'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0430420', 'cui_str': 'Antigen assay'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0851611,"Ultralarge VWF (UL-VWF) forms were elevated in trauma patients at both 0 and 24 hours, when compared to pooled normal plasma (10.0% [8.9%-14.3%] and 11.3% [9.1%-21.2%], respectively, vs. 0.6%).","[{'ForeName': 'Mitchell R', 'Initials': 'MR', 'LastName': 'Dyer', 'Affiliation': 'Pittsburgh Trauma Research Center and the Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Plautz', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Margaret V', 'Initials': 'MV', 'LastName': 'Ragni', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Wyeth', 'Initials': 'W', 'LastName': 'Alexander', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Haldeman', 'Affiliation': 'Pittsburgh Trauma Research Center and the Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Sperry', 'Affiliation': 'Pittsburgh Trauma Research Center and the Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Francis X', 'Initials': 'FX', 'LastName': 'Guyette', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Zuckerbraun', 'Affiliation': 'Pittsburgh Trauma Research Center and the Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Marian A', 'Initials': 'MA', 'LastName': 'Rollins-Raval', 'Affiliation': 'Department of Pathology, University of North Carolina-Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Jay S', 'Initials': 'JS', 'LastName': 'Raval', 'Affiliation': 'Department of Pathology, University of North Carolina-Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Neal', 'Affiliation': 'Pittsburgh Trauma Research Center and the Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Transfusion,['10.1111/trf.15856']
1911,31441936,Effect of Different Financial Incentive Structures on Promoting Physical Activity Among Adults: A Randomized Clinical Trial.,"Importance


Few adults engage in recommended levels of physical activity. Financial incentives can promote physical activity, but little is known about how the structure of these incentives influences their effectiveness (eg, how incentives are disbursed over time).
Objective


To determine if it is more effective to disburse fixed total financial incentives at a constant, increasing, or decreasing rate to encourage physical activity.
Design, Setting, and Participants


A 2-week randomized clinical trial was conducted from June 2 to 15, 2014, using an online platform that automatically records daily steps of pedometer-wearing users and awards points redeemable for cash. The study population comprised 3515 adult users of the online platform in the lower 70th percentile of steps taken among all users before treatment. Data analyses were performed from August 20, 2014, to February 1, 2018. Analysis was performed on an intent-to-treat basis.
Interventions


Participants were randomized to either a control group or to 1 of 3 intervention groups during the 2 weeks of the study. Participants in the control group received a constant daily rate of $0.00001 per step. The 3 intervention groups received a 20-fold incentive increase ($0.00020 per step) distributed differently during the 2 weeks of the study: at a constant, increasing, or decreasing rate. Reminder emails explaining incentive schedules were sent the day before the intervention and halfway through the 2-week intervention.
Main Outcomes and Measures


Change in mean daily steps during the 2-week intervention and 3 weeks after the intervention. The study had 80% power to detect a difference of 280 steps per day during the intervention at α = .05.
Results


The study included 3515 participants (879 in the control condition, 879 in the constant incentive condition, 881 in the increasing incentive condition, and 876 in the decreasing incentive condition). During the intervention, compared with participants in the control group, participants receiving constant incentives logged 306.7 more steps per day (95% CI, 91.5-521.9 steps; P = .005), those receiving decreasing incentives logged 96.9 more steps per day (95% CI, 15.3-178.5 steps; P = .02), and those receiving increasing incentives logged no significant change in steps per day (1.5 steps per day; 95% CI, -81.6 to 84.7 steps; P = .97). One week after the intervention, compared with participants in the control group, only participants receiving constant incentives logged significantly more steps per day (329.5; 95% CI, 20.6-638.4; P = .04). Two and 3 weeks after the intervention, there were no significant differences compared with participants in the control group. Overall, for each $1 spent, participants in the constant incentives group logged 475.4 more steps than those in the increasing incentives group and 429.3 more steps than those in the decreasing incentives group.
Conclusions and Relevance


This study found that financial incentives for physical activity were more effective during a payment period when they were offered at a constant rate rather than an increasing or decreasing rate. However, this effectiveness dissipated shortly after the incentives were removed.
Trial Registration


ClinicalTrials.gov identifier: NCT02154256.",2019,"The study had 80% power to detect a difference of 280 steps per day during the intervention at α = .05.
","['Adults', '3515 adult users of the online platform in the lower 70th percentile of steps taken among all users before treatment', '3515 participants (879 in the control condition, 879 in the constant incentive condition, 881 in the increasing incentive condition, and 876 in the decreasing incentive condition']","['Financial Incentive Structures', 'pedometer-wearing users and awards points redeemable for cash']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0004446', 'cui_str': 'Awards'}]",[],3515.0,0.0833909,"The study had 80% power to detect a difference of 280 steps per day during the intervention at α = .05.
","[{'ForeName': 'Chethan', 'Initials': 'C', 'LastName': 'Bachireddy', 'Affiliation': 'Department of Internal Medicine, Virginia Commonwealth University School of Medicine, Richmond.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Joung', 'Affiliation': 'Operations, Information and Decisions Department, The Wharton School of the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Leslie K', 'Initials': 'LK', 'LastName': 'John', 'Affiliation': 'Negotiation, Organizations and Markets Unit, Harvard Business School, Boston, Massachusetts.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Gino', 'Affiliation': 'Negotiation, Organizations and Markets Unit, Harvard Business School, Boston, Massachusetts.'}, {'ForeName': 'Bradford', 'Initials': 'B', 'LastName': 'Tuckfield', 'Affiliation': 'Operations, Information and Decisions Department, The Wharton School of the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Foschini', 'Affiliation': 'Evidation Health Inc, Santa Barbara, California.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Milkman', 'Affiliation': 'Operations, Information and Decisions Department, The Wharton School of the University of Pennsylvania, Philadelphia.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.9863']
1912,32441655,"A Blended Learning System to Improve Motivation, Mood State, and Satisfaction in Undergraduate Students: Randomized Controlled Trial.","BACKGROUND


Smartphone-based learning, or mobile learning (m-learning), has become a popular learning-and-teaching strategy in educational environments. Blended learning combines strategies such as m-learning with conventional learning to offer continuous training, anytime and anywhere, via innovative learning activities.
OBJECTIVE


The main aim of this work was to examine the short-term (ie, 2-week) effects of a blended learning method using traditional materials plus a mobile app-the iPOT mobile learning app-on knowledge, motivation, mood state, and satisfaction among undergraduate students enrolled in a health science first-degree program.
METHODS


The study was designed as a two-armed, prospective, single-blind, randomized controlled trial. Subjects who met the inclusion criteria were randomly assigned to either the intervention group (ie, blended learning involving traditional lectures plus m-learning via the use of the iPOT app) or the control group (ie, traditional on-site learning). For both groups, the educational program involved 13 lessons on basic health science. The iPOT app is a hybrid, multiplatform (ie, iOS and Android) smartphone app with an interactive teacher-student interface. Outcomes were measured via multiple-choice questions (ie, knowledge), the Instructional Materials Motivation Survey (ie, motivation), the Profile of Mood States scale (ie, mood state), and Likert-type questionnaires (ie, satisfaction and linguistic competence).
RESULTS


A total of 99 students were enrolled, with 49 (49%) in the intervention group and 50 (51%) in the control group. No difference was seen between the two groups in terms of theoretical knowledge gain (P=.92). However, the intervention group subjects returned significantly higher scores than the control group subjects for all postintervention assessed items via the motivation questionnaire (all P<.001). Analysis of covariance (ANCOVA) revealed a significant difference in the confusion and bewilderment component in favor of the intervention group (P=.01), but only a trend toward significance in anger and hostility as well as total score. The intervention group subjects were more satisfied than the members of the control group with respect to five out of the six items evaluated: general satisfaction (P<.001), clarity of the instructions (P<.01), clarity with the use of the learning method (P<.001), enough time to complete the proposed exercises (P<.01), and improvement in the capacity to learn content (P<.001). Finally, the intervention group subjects who were frequent users of the app showed stronger motivation, as well as increased perception of greater gains in their English-language competence, than did infrequent users.
CONCLUSIONS


The blended learning method led to significant improvements in motivation, mood state, and satisfaction compared to traditional teaching, and elicited statements of subjective improvement in terms of competence in English.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03335397; https://clinicaltrials.gov/ct2/show/NCT03335397.",2020,"The intervention group subjects were more satisfied than the members of the control group with respect to five out of the six items evaluated: general satisfaction (P<.001), clarity of the instructions (P<.01), clarity with the use of the learning method (P<.001), enough time to complete the proposed exercises (P<.01), and improvement in the capacity to learn content (P<.001).","['undergraduate students enrolled in a health science first-degree program', 'A total of 99 students were enrolled, with 49 (49%) in the intervention group and 50 (51%) in the control group', 'Subjects who met the inclusion criteria', 'Undergraduate Students']","['intervention group (ie, blended learning involving traditional lectures plus m-learning via the use of the iPOT app) or the control group (ie, traditional on-site learning', 'Smartphone-based learning, or mobile learning (m-learning', 'blended learning method using traditional materials plus a mobile app-the iPOT mobile learning app']","['knowledge, motivation, mood state, and satisfaction', 'Motivation, Mood State, and Satisfaction', 'anger and hostility', 'motivation questionnaire', 'increased perception of greater gains in their English-language competence', 'theoretical knowledge gain', 'multiple-choice questions (ie, knowledge), the Instructional Materials Motivation Survey (ie, motivation), the Profile of Mood States scale (ie, mood state), and Likert-type questionnaires (ie, satisfaction and linguistic competence', 'motivation, mood state, and satisfaction']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0444502', 'cui_str': 'First degree'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0020039', 'cui_str': 'Hostile behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0023741', 'cui_str': 'Linguistics'}]",99.0,0.064006,"The intervention group subjects were more satisfied than the members of the control group with respect to five out of the six items evaluated: general satisfaction (P<.001), clarity of the instructions (P<.01), clarity with the use of the learning method (P<.001), enough time to complete the proposed exercises (P<.01), and improvement in the capacity to learn content (P<.001).","[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Lozano-Lozano', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Fernández-Lao', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Cantarero-Villanueva', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Noguerol', 'Affiliation': 'Departamento de Lenguajes y Sistemas Informáticos e Ingeniería de Software, Universidad Politécnica de Madrid, Madrid, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Álvarez-Salvago', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Mayra', 'Initials': 'M', 'LastName': 'Cruz-Fernández', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Arroyo-Morales', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Noelia', 'Initials': 'N', 'LastName': 'Galiano-Castillo', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}]",Journal of medical Internet research,['10.2196/17101']
1913,32441659,"Investigating the Efficacy and Cost-Effectiveness of Technology-Delivered Personalized Feedback on Dietary Patterns in Young Australian Adults in the Advice, Ideas, and Motivation for My Eating (Aim4Me) Study: Protocol for a Randomized Controlled Trial.","BACKGROUND


Web-based health interventions may be easier to access and time efficient relative to face-to-face interventions and therefore may be the most appropriate mode to engage young adults.
OBJECTIVE


This study aims to investigate the impact of 3 different levels of personalized web-based dietary feedback and support on changes in diet quality.
METHODS


The Advice, Ideas, and Motivation for My Eating (Aim4Me) study is a 12-month assessor-blinded, parallel-group randomized controlled trial evaluating the impact of 3 levels of web-based feedback on diet quality, measured using the Australian Recommended Food Score (ARFS). Participants (N=2570) will primarily be recruited via web-based methods and randomized to 1 of 3 groups. Group 1 (control) will receive the Healthy Eating Quiz, a web-based dietary assessment tool that generates a brief feedback report on diet quality. Individuals randomized to this group can use the brief feedback report to make positive dietary changes. Group 2 will receive the Australian Eating Survey, a web-based dietary assessment tool that generates a comprehensive feedback report on diet quality as well as macro- and micronutrient intake. Group 2 will use the comprehensive feedback report to assist in making positive dietary changes. They will also have access to the Aim4Me website with resources on healthy eating and tools to set goals and self-monitor progress. Group 3 will receive the same intervention as Group 2 (ie, the comprehensive feedback report) in addition to a tailored 30-min video consultation with an accredited practicing dietitian who will use the comprehensive feedback report to assist individuals in making positive dietary changes. The self-determination theory was used as the framework for selecting appropriate website features, including goal setting and self-monitoring. The primary outcome measure is change in diet quality. The completion of questionnaires at baseline and 3, 6, and 12 months will be incentivized with a monetary prize draw.
RESULTS


As of December 2019, 1277 participants have been randomized.
CONCLUSIONS


The web-based delivery of nutrition interventions has the potential to improve dietary intake of young adults. However, the level of support required to improve intake is unknown.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry ACTRN12618000325202; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374420.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/15999.",2020,"Group 1 (control) will receive the Healthy Eating Quiz, a web-based dietary assessment tool that generates a brief feedback report on diet quality.","['Participants (N=2570) will primarily be recruited via web-based methods and randomized to 1 of 3 groups', 'Young Australian Adults', '1277 participants have been randomized', 'young adults']","['Australian Eating Survey, a web-based dietary assessment tool that generates a comprehensive feedback report on diet quality as well as macro- and micronutrient intake', 'personalized web-based dietary feedback', 'Technology-Delivered Personalized Feedback', 'Healthy Eating Quiz, a web-based dietary assessment tool that generates a brief feedback report on diet quality', 'same intervention as Group 2 (ie, the comprehensive feedback report) in addition to a tailored 30-min video consultation with an accredited practicing dietitian who will use the comprehensive feedback report to assist individuals in making positive dietary changes']",['change in diet quality'],"[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",2570.0,0.0978523,"Group 1 (control) will receive the Healthy Eating Quiz, a web-based dietary assessment tool that generates a brief feedback report on diet quality.","[{'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Haslam', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Health Sciences, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Pezdirc', 'Affiliation': 'Faculty of Health and Medicine, University of Newcastle, North Sydney, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Truby', 'Affiliation': 'Department of Nutrition, Dietetics and Food, Monash University, Clayton, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Attia', 'Affiliation': 'School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Hutchesson', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Health Sciences, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Burrows', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Health Sciences, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Callister', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Hides', 'Affiliation': 'School of Psychology, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Billie', 'Initials': 'B', 'LastName': 'Bonevski', 'Affiliation': 'School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Kerr', 'Affiliation': 'School of Public Health, Faculty of Health Sciences, Curtin Institute of Technology, Perth, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lubans', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Education, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Kirkpatrick', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Rollo', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Health Sciences, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'McCaffrey', 'Affiliation': 'Department of Nutrition, Dietetics and Food, Monash University, Clayton, Australia.'}, {'ForeName': 'Clare E', 'Initials': 'CE', 'LastName': 'Collins', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Health Sciences, University of Newcastle, Callaghan, Australia.'}]",JMIR research protocols,['10.2196/15999']
1914,31439506,Extended Lymph Node Dissection for Bladder Cancer: Do Clinical Trials Rule Out a Benefit?,"Although previous studies indicated a therapeutic benefit from superextended or extended lymph node dissection in bladder cancer patients undergoing radical cystectomy, the first prospective randomized trial could not confirm a significant survival benefit. With multimodal approaches including neoadjuvant or adjuvant chemotherapy as a gold standard, demonstrating any benefit may become even more difficult.",2020,"Although previous studies indicated a therapeutic benefit from superextended or extended lymph node dissection in bladder cancer patients undergoing radical cystectomy, the first prospective randomized trial could not confirm a significant survival benefit.","['bladder cancer patients undergoing radical cystectomy', 'Bladder Cancer']",['neoadjuvant or adjuvant chemotherapy'],[],"[{'cui': 'C0005684', 'cui_str': 'Malignant Tumor of Urinary Bladder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0194401', 'cui_str': 'Total resection of urinary bladder (procedure)'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]",[],,0.116947,"Although previous studies indicated a therapeutic benefit from superextended or extended lymph node dissection in bladder cancer patients undergoing radical cystectomy, the first prospective randomized trial could not confirm a significant survival benefit.","[{'ForeName': 'Matthias M', 'Initials': 'MM', 'LastName': 'Heck', 'Affiliation': 'Department of Urology, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany. Electronic address: matthias.heck@tum.de.'}, {'ForeName': 'Jürgen E', 'Initials': 'JE', 'LastName': 'Gschwend', 'Affiliation': 'Department of Urology, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany.'}]",European urology focus,['10.1016/j.euf.2019.08.003']
1915,32437174,"A transdiagnostic minority stress intervention for gender diverse sexual minority women's depression, anxiety, and unhealthy alcohol use: A randomized controlled trial.","OBJECTIVE


To remedy the notable gap in evidence-based treatments for sexual minority women, this study tested the efficacy of a minority-stress-focused cognitive-behavioral treatment intended to improve this population's mental and behavioral health.
METHOD


The intervention, EQuIP (Empowering Queer Identities in Psychotherapy), was adapted from a transdiagnostic cognitive-behavioral treatment as also recently adapted for sexual minority men. Sexual minority women at risk of mental and behavioral health problems ( n  = 19) and expert providers with this population ( n  = 12) shaped the treatment's development, including by supporting its primary focus on universal and minority-stress-focused processes underlying this population's disproportionately poor mental and behavioral health. The resulting treatment was then delivered to young adult sexual minority women ( n  = 60;  M  age = 25.58; 41.67% racial/ethnic minority; 43.33% transgender/nonbinary) experiencing depression/anxiety and past 90-day heavy alcohol use.
RESULTS


Compared to waitlist ( n  = 30), participants randomized to immediately receive EQuIP ( n  = 30) experienced significantly reduced depression and anxiety ( d  = 0.85, 0.86, respectively); effects for alcohol use problems were smaller ( d  = 0.29) and marginally significant. In pre- to post-intervention pooled analyses, effect sizes for minority stress processes (mean  d  = .25) and universal risk factors (mean  d  = .48), through which the treatment was expected to work, were small and moderate, respectively, and in the expected direction.
CONCLUSIONS


This study provides initial support for a minority-stress-focused transdiagnostic cognitive-behavioral treatment for sexual minority women. These first results can launch exploration of other mechanisms and modalities through which to equip this population with evidence-based support. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"In pre- to post-intervention pooled analyses, effect sizes for minority stress processes (mean  d  = .25) and universal risk factors (mean  d  = .48), through which the treatment was expected to work, were small and moderate, respectively, and in the expected direction.
","['sexual minority men', ""Sexual minority women at risk of mental and behavioral health problems ( n  = 19) and expert providers with this population ( n  = 12) shaped the treatment's development, including by supporting its primary focus on universal and minority-stress-focused processes underlying this population's disproportionately poor mental and behavioral health"", ""gender diverse sexual minority women's depression, anxiety, and unhealthy alcohol use"", 'sexual minority women', 'young adult sexual minority women ( n  = 60;  M  age = 25.58; 41.67% racial/ethnic minority; 43.33% transgender/nonbinary) experiencing depression/anxiety and past 90-day heavy alcohol use']","['transdiagnostic minority stress intervention', 'EQuIP']","['universal risk factors', 'depression and anxiety']","[{'cui': 'C4277573', 'cui_str': 'Lesbigay Persons'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0558141', 'cui_str': 'Transsexual'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}]","[{'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0292329,"In pre- to post-intervention pooled analyses, effect sizes for minority stress processes (mean  d  = .25) and universal risk factors (mean  d  = .48), through which the treatment was expected to work, were small and moderate, respectively, and in the expected direction.
","[{'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Pachankis', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'McConocha', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Kirsty A', 'Initials': 'KA', 'LastName': 'Clark', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Kriti', 'Initials': 'K', 'LastName': 'Behari', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Benjamin K', 'Initials': 'BK', 'LastName': 'Fetzner', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Cal D', 'Initials': 'CD', 'LastName': 'Brisbin', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Jillian R', 'Initials': 'JR', 'LastName': 'Scheer', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Keren', 'Initials': 'K', 'LastName': 'Lehavot', 'Affiliation': 'Denver-Seattle Center of Innovation for Veteran-Centered and Value-Driven Care.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000508']
1916,32441759,A smartphone game to prevent HIV among young Kenyans: local perceptions of mechanisms of effect.,"Electronic games delivered via smartphones have the potential to become valuable tools in HIV prevention in high-prevalence and low-resource international settings. To ground theoretical elaboration around novel mHealth interventions in contextual realities, it is important to understand the mechanisms of their effects as perceived by local populations. Such perspectives are particularly important when working cross-culturally. 'Tumaini' is an interactive narrative-based smartphone game that uses a 'choose-your-own-adventure' format. It is designed to prevent HIV among young African adolescents (aged 11-14) by increasing age and condom use at first sex. It was developed with a US-based commercial game developer and is grounded in social behavioral theory, evidence-based practice and contextually relevant scenarios. In a 2017 randomized pilot study (n = 60) in Western Kenya, 'Tumaini' showed promising effects on behavioral mediators of sexual debut. In subsequent focus group discussions, adolescent participants and their parents shared their perceptions of the game's mechanisms of effect, which included motivation to play, future orientation, decision-making, relationship to a diverse range of characters and a bridging of the virtual and real worlds. These findings align with our theoretical framework, confirm its successful translation into the intervention and will inform mediation analyses in an upcoming efficacy trial.",2020,"In a 2017 randomized pilot study (n = 60) in Western Kenya, 'Tumaini' showed promising effects on behavioral mediators of sexual debut.","[""2017 randomized pilot study (n\u2009=\u200960) in Western Kenya, 'Tumaini"", 'young African adolescents (aged 11-14) by increasing age and condom use at first sex']",[],['behavioral mediators of sexual debut'],"[{'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]",[],"[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}]",,0.0581283,"In a 2017 randomized pilot study (n = 60) in Western Kenya, 'Tumaini' showed promising effects on behavioral mediators of sexual debut.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Winskell', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA 30322, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Sabben', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA 30322, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Akelo', 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, HIV Research Branch, Kisumu, Kenya.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': ""Ondeng'e"", 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, HIV Research Branch, Kisumu, Kenya.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Odero', 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, HIV Research Branch, Kisumu, Kenya.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Mudhune', 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, HIV Research Branch, Kisumu, Kenya.'}]",Health education research,['10.1093/her/cyaa011']
1917,32133542,"Efficacy of combined liman peloid baths and heliotherapy in the treatment of psoriasis at Cervia spa, Emilia, Italy.","This study assessed the effects of liman peloid, followed by bath and heliotherapy in psoriatic patients at Cervia, Emilia, Italy. The psoriatic patients were randomized into two groups: group 1 with 56 patients, treated with liman applications, bath, and heliotherapy, and group 2 with 35 subjects, treated with mud-bath therapy using a clay peloid mixed with tap water and heliotherapy. Data was collected for the following: psoriasis area and severity index (PASI); delta-PASI (difference between post- and pre-treatment PASI); delta-PASI3 and delta-PASI6, 3 and 6 months after the end of treatment, respectively; psoriasis recurrences; and the use of both topical and systemic drugs. Although not significant, a decrease in PASI was recorded in group 1 at the end of treatment and after 3 and 6 months. Compared with group 2, there was a significant change in delta-PASI, delta-PASI3, and psoriasis recurrences in group 1 as well as a significant reduction in the topical use of drugs, both cortisone and nonsteroid drugs. This is the first and preliminary study which documented the efficacy of a specific protocol of liman bath heliotherapy in psoriatic patients as documented by a reduction in delta-PASI and delta-PASI3, a decrease in psoriasis recurrences, and use of topical drugs.",2020,"Although not significant, a decrease in PASI was recorded in group 1 at the end of treatment and after 3 and 6 months.","['psoriatic patients', 'psoriasis at Cervia spa, Emilia, Italy', 'psoriatic patients at Cervia, Emilia, Italy']","['liman applications, bath, and heliotherapy, and group 2 with 35 subjects, treated with mud-bath therapy using a clay peloid mixed with tap water and heliotherapy', 'liman peloid, followed by bath and heliotherapy', 'combined liman peloid baths and heliotherapy']","['psoriasis area and severity index (PASI); delta-PASI', 'PASI', 'delta-PASI, delta-PASI3, and psoriasis recurrences']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0022277', 'cui_str': 'Italy'}]","[{'cui': 'C0150141'}, {'cui': 'C0018878', 'cui_str': 'Heliotherapy'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0086656', 'cui_str': 'Mud Baths'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0055863'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C2919405', 'cui_str': 'Tap water (substance)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",,0.0228538,"Although not significant, a decrease in PASI was recorded in group 1 at the end of treatment and after 3 and 6 months.","[{'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Melandri', 'Affiliation': 'Dermatology Units and Burn Center Ausl Romagna, Bufalini Hospital, Viale Ghirotti, 286,, 47521, Cesena, Italy.'}, {'ForeName': 'Vincenzo Maria', 'Initials': 'VM', 'LastName': 'Albano', 'Affiliation': 'Dermatology Unit Ausl Romagna, Infermi Hospital, Viale Stradone, 9, 48018, Faenza, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Venturi', 'Affiliation': 'Dermatology Units and Burn Center Ausl Romagna, Bufalini Hospital, Viale Ghirotti, 286,, 47521, Cesena, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Flamigni', 'Affiliation': 'Riolo Terme, Via Firenze, 15, 48025, Riolo T, RA, Italy.'}, {'ForeName': 'Mariapia', 'Initials': 'M', 'LastName': 'Vairetti', 'Affiliation': 'Department Internal Medicine and Therapeutics, University of Pavia, Via Ferrata, 9a, 27100, Pavia, Italy. mariapia.vairetti@unipv.it.'}]",International journal of biometeorology,['10.1007/s00484-020-01888-y']
1918,31418811,Effect of Physical Activity Coaching on Acute Care and Survival Among Patients With Chronic Obstructive Pulmonary Disease: A Pragmatic Randomized Clinical Trial.,"Importance


While observational studies show that physical inactivity is associated with worse outcomes in chronic obstructive pulmonary disease (COPD), there are no population-based trials to date testing the effectiveness of physical activity (PA) interventions to reduce acute care use or improve survival.
Objective


To evaluate the long-term effectiveness of a community-based PA coaching intervention in patients with COPD.
Design, Setting, and Participants


Pragmatic randomized clinical trial with preconsent randomization to the 12-month Walk On! (WO) intervention or standard care (SC). Enrollment occurred from July 1, 2015, to July 31, 2017; follow-up ended in July 2018. The setting was Kaiser Permanente Southern California sites. Participants were patients 40 years or older who had any COPD-related acute care use in the previous 12 months; only patients assigned to WO were approached for consent to participate in intervention activities.
Interventions


The WO intervention included collaborative monitoring of PA step counts, semiautomated step goal recommendations, individualized reinforcement, and peer/family support. Standard COPD care could include referrals to pulmonary rehabilitation.
Main Outcomes and Measures


The primary outcome was a composite binary measure of all-cause hospitalizations, observation stays, emergency department visits, and death using adjusted logistic regression in the 12 months after randomization. Secondary outcomes included self-reported PA, COPD-related acute care use, symptoms, quality of life, and cardiometabolic markers.
Results


All 2707 eligible patients (baseline mean [SD] age, 72 [10] years; 53.7% female; 74.3% of white race/ethnicity; and baseline mean [SD] percent forced expiratory volume in the first second of expiration predicted, 61.0 [22.5]) were randomly assigned to WO (n = 1358) or SC (n = 1349). The intent-to-treat analysis showed no differences between WO and SC on the primary all-cause composite outcome (odds ratio [OR], 1.09; 95% CI, 0.92-1.28; P = .33) or in the individual outcomes. Prespecified, as-treated analyses compared outcomes between all SC and 321 WO patients who participated in any intervention activities (23.6% [321 of 1358] uptake). The as-treated, propensity score-weighted model showed nonsignificant positive estimates in favor of WO participants compared with SC on all-cause hospitalizations (OR, 0.84; 95% CI, 0.65-1.10; P = .21) and death (OR, 0.62; 95% CI, 0.35-1.11; P = .11). More WO participants reported engaging in PA compared with SC (47.4% [152 of 321] vs 30.7% [414 of 1349]; P < .001) and had improvements in the Patient-Reported Outcomes Measurement Information System 10 physical health domain at 6 months. There were no group differences in other secondary outcomes.
Conclusions and Relevance


Participation in a PA coaching program by patients with a history of COPD exacerbations was insufficient to effect improvements in acute care use or survival in the primary analysis.
Trial Registration


ClinicalTrials.gov identifier: NCT02478359.",2019,"The intent-to-treat analysis showed no differences between WO and SC on the primary all-cause composite outcome (odds ratio [OR], 1.09; 95% CI, 0.92-1.28; P = .33) or in the individual outcomes.","['patients with COPD', 'chronic obstructive pulmonary disease (COPD', '2707 eligible patients (baseline mean [SD] age, 72 [10] years; 53.7% female; 74.3% of white race/ethnicity; and baseline mean [SD] percent forced expiratory volume in the first second of expiration predicted, 61.0 [22.5', 'patients with a history of COPD exacerbations', 'Participants were patients 40 years or older who had any COPD-related acute care use in the previous 12 months; only patients assigned to WO were approached for consent to participate in intervention activities', 'Patients With Chronic Obstructive Pulmonary Disease']","['WO) intervention or standard care (SC', 'Physical Activity Coaching', 'PA coaching program', 'physical activity (PA) interventions', 'community-based PA coaching intervention']","['death', 'Acute Care and Survival', 'self-reported PA, COPD-related acute care use, symptoms, quality of life, and cardiometabolic markers', 'composite binary measure of all-cause hospitalizations, observation stays, emergency department visits, and death using adjusted logistic regression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C4517649', 'cui_str': 'Twenty-two point five'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0206031', 'cui_str': 'Logistic Regression'}]",2707.0,0.159903,"The intent-to-treat analysis showed no differences between WO and SC on the primary all-cause composite outcome (odds ratio [OR], 1.09; 95% CI, 0.92-1.28; P = .33) or in the individual outcomes.","[{'ForeName': 'Huong Q', 'Initials': 'HQ', 'LastName': 'Nguyen', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena.'}, {'ForeName': 'Marilyn L', 'Initials': 'ML', 'LastName': 'Moy', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'In-Lu Amy', 'Initials': 'IA', 'LastName': 'Liu', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena.'}, {'ForeName': 'Vincent S', 'Initials': 'VS', 'LastName': 'Fan', 'Affiliation': 'University of Washington, Seattle.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Gould', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena.'}, {'ForeName': 'Smita A', 'Initials': 'SA', 'LastName': 'Desai', 'Affiliation': 'Kaiser Permanente Southern California, San Diego.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Towner', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Yuen', 'Affiliation': 'Kaiser Permanente Southern California, Orange County, Anaheim.'}, {'ForeName': 'Janet S', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena.'}, {'ForeName': 'Stacy J', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena.'}, {'ForeName': 'Anny H', 'Initials': 'AH', 'LastName': 'Xiang', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.9657']
1919,32134208,"Efficacy of multidomain interventions to improve physical frailty, depression and cognition: data from cluster-randomized controlled trials.","BACKGROUND


Frailty is the pre-eminent exigency of aging. Although frailty-related impairments are preventable, and multidomain interventions appear more effective than unimodal ones, the optimal components remain uncertain.
METHODS


We devised multidomain interventions against physical and cognitive decline among prefrail/frail community-dwelling ≥65-year-olds and evaluated these in complementary cluster-randomized trials of efficacy and participant empowerment. The Efficacy Study compared ~3-monthly telephone consultations vs. 16, 2 h sessions/year comprising communally partaken physical and cognitive training plus nutrition and disease education; the Empowerment Study compared the standard Efficacy Study multidomain intervention (Sessions 1-10) vs. an enhanced version redesigned to empower and motivate individual participants. Changes from baseline in physical, functional, and cognitive performance were measured after 6 and 12 months in the Efficacy Study and after 6 months in the Empowerment Study, with post-intervention follow-up at 9 months. Primary outcomes are as follows: Cardiovascular Health Study frailty score; gait speed; handgrip strength; and Montreal Cognitive Assessment (MoCA). Secondary outcomes are as follows: instrumental activities of daily living; metabolic equivalent of task (MET); depressed mood (Geriatric Depression Scale-5 ≥2); and malnutrition (Mini-Nutritional Assessment short-form ≤11). Intervention effects were analyzed using a generalized linear mixed model.
RESULTS


Efficacy Study participants (n = 1082, 40 clusters) were 75.1 ± 6.3 years old, 68.7% women, and 64.7% prefrail/frail; analytic clusters: 19 intervention (410/549 completed) vs. 21 control (375/533 completed). Empowerment Study participants (n = 440, 14 clusters) were 75.9 ± 7.1 years old, 83.6% women, and 56.7% prefrail/frail; analytic clusters: seven intervention (209/230 completed) vs. seven control (189/210 completed). The standard and enhanced multidomain interventions both reduced frailty and significantly improved aspects of physical, functional, and cognitive performance, especially among ≥75-year-olds. Standard multidomain intervention decreased depression [odds ratio 0.56, 95% confidence interval (CI) 0.32, 0.99] and malnutrition (odds ratio 0.45, 95% CI 0.26, 0.78) by 12 months and improved concentration at Months 6 (0.23, 95% CI 0.04, 0.42) and 12 (0.46, 95% CI 0.22, 0.70). Participant empowerment augmented activity (4.67 MET/h, 95% CI 1.64, 7.69) and gait speed (0.06 m/s, 95% CI 0.00, 0.11) at 6 months, with sustained improvements in delayed recall (0.63, 95% CI 0.20, 1.06) and MoCA performance (1.29, 95% CI 0.54, 2.03), and less prevalent malnutrition (odds ratio 0.39, 95% CI 0.18, 0.84), 3 months after the intervention ceased.
CONCLUSIONS


Pragmatic multidomain intervention can diminish physical frailty, malnutrition, and depression and enhance cognitive performance among community-dwelling elders, especially ≥75-year-olds; this might supplement healthy aging policies, probably more effectively if participants are empowered.",2020,"Standard multidomain intervention decreased depression [odds ratio 0.56, 95% confidence interval (CI) 0.32, 0.99] and malnutrition (odds ratio 0.45, 95% CI 0.26, 0.78) by 12 months and improved concentration at Months 6 (0.23, 95% CI 0.04, 0.42) and 12 (0.46, 95% CI 0.22, 0.70).","['prefrail/frail community-dwelling ≥65-year-olds', 'Efficacy Study participants (n = 1082, 40 clusters) were 75.1 ± 6.3 years old, 68.7% women, and 64.7% prefrail/frail; analytic clusters: 19 intervention (410/549 completed) vs. 21 control (375/533 completed', 'Empowerment Study participants (n = 440, 14 clusters) were 75.9 ± 7.1 years old, 83.6% women, and 56.7% prefrail/frail; analytic clusters: seven intervention (209/230 completed) vs. seven control (189/210 completed', 'community-dwelling elders']","['multidomain interventions', 'multidomain intervention (Sessions 1-10) vs. an enhanced version redesigned to empower and motivate individual participants', '3-monthly telephone consultations vs. 16, 2 h sessions/year comprising communally partaken physical and cognitive training plus nutrition and disease education', 'Pragmatic multidomain intervention']","['Cardiovascular Health Study frailty score; gait speed; handgrip strength; and Montreal Cognitive Assessment (MoCA', 'gait speed', 'physical, functional, and cognitive performance', 'physical frailty, depression and cognition', 'prevalent malnutrition', 'malnutrition', 'instrumental activities of daily living; metabolic equivalent of task (MET); depressed mood (Geriatric Depression Scale-5 ≥2); and malnutrition (Mini-Nutritional Assessment short-form ≤11', 'MoCA performance', 'delayed recall', 'depression', 'physical frailty, malnutrition, and depression and enhance cognitive performance']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C4517777', 'cui_str': '440 (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}]","[{'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0175745', 'cui_str': 'Telephone consultation'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C3496286'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C1290928', 'cui_str': 'Instrumental activity of daily living (observable entity)'}, {'cui': 'C2983100', 'cui_str': 'MET - metabolic equivalent of task'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale (assessment scale)'}, {'cui': 'C3850124', 'cui_str': 'Mini Nutrition Assessment'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}]",,0.0954159,"Standard multidomain intervention decreased depression [odds ratio 0.56, 95% confidence interval (CI) 0.32, 0.99] and malnutrition (odds ratio 0.45, 95% CI 0.26, 0.78) by 12 months and improved concentration at Months 6 (0.23, 95% CI 0.04, 0.42) and 12 (0.46, 95% CI 0.22, 0.70).","[{'ForeName': 'Liang-Kung', 'Initials': 'LK', 'LastName': 'Chen', 'Affiliation': 'Center for Geriatrics and Gerontology, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'An-Chun', 'Initials': 'AC', 'LastName': 'Hwang', 'Affiliation': 'Center for Geriatrics and Gerontology, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Wei-Ju', 'Initials': 'WJ', 'LastName': 'Lee', 'Affiliation': 'Aging and Health Research Center, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Li-Ning', 'Initials': 'LN', 'LastName': 'Peng', 'Affiliation': 'Center for Geriatrics and Gerontology, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ming-Hsien', 'Initials': 'MH', 'LastName': 'Lin', 'Affiliation': 'Center for Geriatrics and Gerontology, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Neil', 'Affiliation': 'Full Universe Integrated Marketing, Taipei, Taiwan.'}, {'ForeName': 'Shu-Fang', 'Initials': 'SF', 'LastName': 'Shih', 'Affiliation': 'Department of Health Management and Policy, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Ching-Hui', 'Initials': 'CH', 'LastName': 'Loh', 'Affiliation': 'Aging and Health Research Center, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shu-Ti', 'Initials': 'ST', 'LastName': 'Chiou', 'Affiliation': 'Institute of Public Health, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Journal of cachexia, sarcopenia and muscle",['10.1002/jcsm.12534']
1920,32438624,"Effect of Supplementation with  Saccharomyces Boulardii  on Academic Examination Performance and Related Stress in Healthy Medical Students: A Randomized, Double-Blind, Placebo-Controlled Trial.","In recent years, bacterial probiotic dietary supplementation has emerged as a promising way to improve cognition and to alleviate stress and anxiety; however, yeast probiotics have not been tested. The aim of the present study was to determine whether 30-day supplementation with  Saccharomyces boulardii  enhances academic performance under stress and affects stress markers. The trial was retrospectively registered at clinicaltrials.gov (NCT03427515). Healthy medical students were randomized to supplement their diet with  Saccharomyces boulardii  CNCM I-1079 or placebo before sitting for an academic examination, which served as a model of stress. The grades of a final examination adjusted to subject knowledge tested in non-stressful conditions was used as a primary outcome measure. Psychometrically evaluated state anxiety, cortisol and metanephrine salivary levels, and pulse rate were tested at a non-stressful time point before the intervention as well as just before the stressor. Fifty enrolled participants (22.6 ± 1.4 years of age, 19 males) completed the trial in the  Saccharomyces  and placebo arms. Supplementation with  Saccharomyces  did not significantly modify examination performance or increase in state anxiety, salivary cortisol, and metanephrine. However, the intervention resulted in higher increase in pulse rate under stress as compared to placebo by 10.4 (95% CI 4.2-16.6) min -1  ( p  = 0.0018), and the effect positively correlated with increase in salivary metanephrine (Pearson's r = 0.35, 95% CI 0.09-0.58,  p  = 0.012). An  intention-to-treat  analysis was in line with the  per-protocol  one. In conclusion, supplementation with  Saccharomyces boulardii  CNCM I-1079 appears largely ineffective in improving academic performance under stress and in alleviating some stress markers, but it seems to increase pulse rate under stress, which may hypothetically reflect enhanced sympathoadrenal activity.",2020,"Supplementation with  Saccharomyces  did not significantly modify examination performance or increase in state anxiety, salivary cortisol, and metanephrine.","['Healthy medical students', 'Fifty enrolled participants (22.6 ± 1.4 years of age, 19 males) completed the trial in the  Saccharomyces  and placebo arms', 'Healthy Medical Students']","['Saccharomyces boulardii', 'Placebo', 'Supplementation with  Saccharomyces Boulardii', 'supplement their diet with  Saccharomyces boulardii  CNCM I-1079 or placebo', 'placebo']","['state anxiety, salivary cortisol, and metanephrine', 'pulse rate under stress', 'examination performance', 'Academic Examination Performance and Related Stress', 'state anxiety, cortisol and metanephrine salivary levels, and pulse rate', 'salivary metanephrine']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0036024', 'cui_str': 'Saccharomyces'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0772093', 'cui_str': 'Saccharomyces boulardii'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0025562', 'cui_str': 'Metanephrine'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",50.0,0.441354,"Supplementation with  Saccharomyces  did not significantly modify examination performance or increase in state anxiety, salivary cortisol, and metanephrine.","[{'ForeName': 'Michał Seweryn', 'Initials': 'MS', 'LastName': 'Karbownik', 'Affiliation': 'Department of Pharmacology and Toxicology, Medical University of Lodz, Żeligowskiego 7/9, 90-752 Łódź, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Kręczyńska', 'Affiliation': 'Department of Infectious Diseases and Hepatology, Medical University of Lodz, Kniaziewicza 1/5, 91-347 Łódź, Poland.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Kwarta', 'Affiliation': 'Department of Pediatrics and Allergy, Copernicus Memorial Hospital in Łódź, Medical University of Lodz, Piłsudskiego 71, 90-329 Łódź, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Cybula', 'Affiliation': 'Oklahoma Medical Research Foundation, Aging and Metabolism Program, 825 NE 13th St, Oklahoma City, OK 73104, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wiktorowska-Owczarek', 'Affiliation': 'Department of Pharmacology and Toxicology, Medical University of Lodz, Żeligowskiego 7/9, 90-752 Łódź, Poland.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Kowalczyk', 'Affiliation': 'Department of Pharmacology and Toxicology, Medical University of Lodz, Żeligowskiego 7/9, 90-752 Łódź, Poland.'}, {'ForeName': 'Tadeusz', 'Initials': 'T', 'LastName': 'Pietras', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Lodz, Kopcińskiego 22, 90-153 Łódź, Poland.'}, {'ForeName': 'Janusz', 'Initials': 'J', 'LastName': 'Szemraj', 'Affiliation': 'Department of Medical Biochemistry, Medical University in Lodz, Mazowiecka 6/8, 92-215 Łódź, Poland.'}]",Nutrients,['10.3390/nu12051469']
1921,32437937,Causes of fever in primary care in Southeast Asia and the performance of C-reactive protein in discriminating bacterial from viral pathogens.,"OBJECTIVES


This study investigated causes of fever in the primary levels of care in Southeast Asia, and evaluated whether C-reactive protein (CRP) could distinguish bacterial from viral pathogens.
METHODS


Blood and nasopharyngeal swab specimens were taken from children and adults with fever (>37.5 °C) or history of fever (<14 days) in Thailand and Myanmar.
RESULTS


Of 773 patients with at least one blood or nasopharyngeal swab specimen collected, 227 (29.4%) had a target organism detected. Influenza virus type A was detected in 85/227 cases (37.5%), followed by dengue virus (30 cases, 13.2%), respiratory syncytial virus (24 cases, 10.6%) and Leptospira spp. (nine cases, 4.0%). Clinical outcomes were similar between patients with a bacterial or a viral organism, regardless of antibiotic prescription. CRP was higher among patients with a bacterial organism compared with those with a viral organism (median 18 mg/L, interquartile range [10-49] versus 10 mg/L [≤8-22], p = 0.003), with an area under the curve of 0.65 (95% CI 0.55-0.75).
CONCLUSIONS


Serious bacterial infections requiring antibiotics are an exception rather than the rule in the first line of care. CRP testing could assist in ruling out such cases in settings where diagnostic uncertainty is high and routine antibiotic prescription is common. The original CRP randomised controlled trial was registered with ClinicalTrials.gov, number NCT02758821.",2020,"CRP was higher among patients with a bacterial organism compared to those with a viral organism (median 18mg/L, interquartile range [10-49] versus 10mg/L [≤8-22], p-value 0.003), with an area under the curve of 0.65, 95% confidence interval (0.55-0.75).
","['fever in the primary levels of care in Southeast Asia', '773 patients with at least one blood or nasopharyngeal swab specimen collected, 227 (29.4%) had a target organism detected', 'Blood and nasopharyngeal swab specimens were taken from children and adults with fever (>37.5˚C) or history of fever (<14 days) in Thailand and Myanmar']",[],"['respiratory syncytial virus', 'CRP']","[{'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003983', 'cui_str': 'South east Asian country'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0029235', 'cui_str': 'Organism'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0006416', 'cui_str': 'Burma'}]",[],"[{'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",773.0,0.237316,"CRP was higher among patients with a bacterial organism compared to those with a viral organism (median 18mg/L, interquartile range [10-49] versus 10mg/L [≤8-22], p-value 0.003), with an area under the curve of 0.65, 95% confidence interval (0.55-0.75).
","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Althaus', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom. Electronic address: thomas.a@tropmedres.ac.'}, {'ForeName': 'Janjira', 'Initials': 'J', 'LastName': 'Thaipadungpanit', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Greer', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Myo Maung Maung', 'Initials': 'MMM', 'LastName': 'Swe', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Myanmar-Oxford Clinical Research Unit (MOCRU), Medical Action Myanmar (MAM), Yangon, Myanmar.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Dittrich', 'Affiliation': 'Foundation for Innovative New Diagnostics (FIND), Geneva, Switzerland.'}, {'ForeName': 'Pimnara', 'Initials': 'P', 'LastName': 'Peerawaranun', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Pieter W', 'Initials': 'PW', 'LastName': 'Smit', 'Affiliation': 'Maasstad Ziekenhuis Hospital, Department of Medical Microbiology, Rotterdam, The Netherlands; Public Health Laboratory (GGD), Amsterdam, The Netherlands.'}, {'ForeName': 'Tri', 'Initials': 'T', 'LastName': 'Wangrangsimakul', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Blacksell', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Jonas M', 'Initials': 'JM', 'LastName': 'Winchell', 'Affiliation': 'Division of Bacterial Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Maureen H', 'Initials': 'MH', 'LastName': 'Diaz', 'Affiliation': 'Division of Bacterial Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Nicholas P J', 'Initials': 'NPJ', 'LastName': 'Day', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Smithuis', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom; Myanmar-Oxford Clinical Research Unit (MOCRU), Medical Action Myanmar (MAM), Yangon, Myanmar.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Turner', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom; Cambodia-Oxford Medical Research Unit (COMRU), Angkor Hospital for Children, Siem Reap, Cambodia.'}, {'ForeName': 'Yoel', 'Initials': 'Y', 'LastName': 'Lubell', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.05.016']
1922,31238784,Can WeChat group-based intervention reduce reperfusion time in patients with ST-segment myocardial infarction? A controlled before and after study.,"BACKGROUND


Pre-hospital identification of acute ST-elevation myocardial infarction and activation of the catheterization laboratory can reduce first medical contact to wire-crossing times. We conducted a study on providing 24-hour tele-electrocardiography services via the WeChat group application, aiming to reduce the time taken for diagnosis and treatment of ST-elevation myocardial infarction.
METHODS


A controlled before and after study was conducted on 140 ST-elevation myocardial infarction patients who were initially seen in non-percutaneous coronary intervention-capable hospital and transferred for primary percutaneous coronary intervention at our percutaneous coronary intervention centre from 1 February to 31 October 2018. The WeChat group had 70 patients with pre-hospital electrocardiography transmission via WeChat and the control group had 70 patients who did not transfer pre-hospital electrocardiography. The reperfusion time of the two groups was compared to evaluate the effect of the WeChat group intervention.
RESULTS


In the WeChat group versus the control group, the median symptom onset to first medical contact time was similar (129 vs 150 min,  p  > 0.05), but the median first medical contact to wire, door to wire and first medical contact to catheterization laboratory activity were significantly shorter (132 vs 171 minutes,  p  < 0.001; 60 vs 95 minutes,  p  < 0.001; 29 vs 74 minutes,  p  < 0.001, respectively).
CONCLUSIONS


Pre-hospital electrocardiography transfer via a WeChat group resulted in earlier reperfusion of ST-elevation myocardial infarction patients who were transferred from the non-percutaneous coronary intervention centre.",2019,,['patients with ST-segment myocardial infarction'],[],['reperfusion time'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0429029', 'cui_str': 'ST segment (observable entity)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]",[],"[{'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0102293,,"[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Shantou University Medical College, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Shantou University Medical College, China.'}, {'ForeName': 'Haojia', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Shantou University Medical College, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Shantou University Medical College, China.'}, {'ForeName': 'Shushuang', 'Initials': 'S', 'LastName': 'Feng', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Shantou University Medical College, China.'}, {'ForeName': 'Yonghong', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Shantou University Medical College, China.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19856473']
1923,30688135,Pregabalin as Adjunctive Treatment for Focal Onset Seizures in Pediatric Patients: A Randomized Controlled Trial.,"Efficacy and safety of pregabalin as adjunctive treatment for children (aged 4-16 years) with partial-onset seizures, hereafter termed focal onset seizures for this study, was evaluated. This double-blind, randomized, placebo-controlled, international study had 3 phases: 8-week baseline, 12-week double-blind treatment (2-week dose escalation; 10-week fixed dose), and 1-week taper. Selection criteria included experiencing focal onset seizures and receiving a stable regimen of 1 to 3 antiepileptic drugs. Study treatments were pregabalin 2.5 mg/kg/d, 10 mg/kg/d, or placebo; doses were increased to 3.5 or 14 mg/kg/d for subjects weighing <30 kg. The key endpoints were change in log e (28-day seizure rate), achieving a ≥50% seizure responder rate, safety, and tolerability during double-blind treatment. Subjects (n = 295; mean age 10.2 years, 55% male, 69% white) were randomized to pregabalin 2.5 mg/kg/d (n = 104), 10 mg/kg/d (n = 97), or placebo (n = 94). A statistically significant reduction in log e (28-day seizure rate) was demonstrated with pregabalin 10 mg/kg/d (a 19.9% improvement over placebo; P = .0185). Seizure frequency was numerically improved (statistically nonsignificant) with pregabalin 2.5 mg/kg/d ( P = .2577). Responder rate significantly favored pregabalin 10 mg/kg/d (40.6%, P = .0068) compared with placebo (22.6%) and was numerically improved with pregabalin 2.5 mg/kg/d (29.1%, P = .2600). Common adverse events (≥10% of any group) in 10 mg/kg/d, 2.5 mg/kg/d, and placebo groups, respectively, included somnolence (25.8%, 17.3%, 13.8%), increased weight (13.4%, 3.8%, 4.3%), and increased appetite (10.3%, 6.7%, 4.3%). Pregabalin 10 mg/kg/d demonstrated efficacy in seizure frequency reduction in children with focal onset seizures compared with placebo, and both pregabalin doses were generally safe and well tolerated. www.clinicialtrials.gov identifier NCT01389596; EudraCT #2010-020852-79.",2019,A statistically significant reduction in log e (28-day seizure rate) was demonstrated with pregabalin 10 mg/kg/d (a 19.9% improvement over placebo; P = .0185).,"['children with focal onset seizures', 'Selection criteria included experiencing focal onset seizures and receiving a stable regimen of 1 to 3 antiepileptic drugs', 'children (aged 4-16 years) with partial-onset seizures, hereafter termed focal onset seizures', 'Pediatric Patients', 'Subjects (n = 295; mean age 10.2 years, 55% male, 69% white']","['Pregabalin', 'pregabalin', 'placebo']","['safe and well tolerated', 'increased weight', 'log e (28-day seizure rate', 'included somnolence', 'Seizure frequency', 'change in log e (28-day seizure rate), achieving a ≥50% seizure responder rate, safety, and tolerability', 'Efficacy and safety', 'appetite', 'Responder rate']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0242801', 'cui_str': 'Selection Criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0003299', 'cui_str': 'Antiepileptic Agents'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}]",,0.664282,A statistically significant reduction in log e (28-day seizure rate) was demonstrated with pregabalin 10 mg/kg/d (a 19.9% improvement over placebo; P = .0185).,"[{'ForeName': 'Jeremias', 'Initials': 'J', 'LastName': 'Antinew', 'Affiliation': '1 Pfizer Global Research and Development, Groton, CT, USA.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pitrosky', 'Affiliation': '2 Pfizer Global Product Development Group, Paris, France.'}, {'ForeName': 'Lloyd', 'Initials': 'L', 'LastName': 'Knapp', 'Affiliation': '1 Pfizer Global Research and Development, Groton, CT, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Almas', 'Affiliation': '3 Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Verne', 'Initials': 'V', 'LastName': 'Pitman', 'Affiliation': '1 Pfizer Global Research and Development, Groton, CT, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': '1 Pfizer Global Research and Development, Groton, CT, USA.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Craiu', 'Affiliation': '4 Pediatric Neurology Discipline, Neurosciences Department, Carol Davila University of Medicine, Bucharest, Romania.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Modequillo', 'Affiliation': '5 Department of Pediatrics, Perpetual Succour Hospital, Cebu City, Philippines.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Nordli', 'Affiliation': ""6 Neuroscience Institute at Children's Hospital Los Angeles, Los Angeles, CA, USA.""}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Farkas', 'Affiliation': '7 First Department of Pediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Mark Kristof', 'Initials': 'MK', 'LastName': 'Farkas', 'Affiliation': '7 First Department of Pediatrics, Semmelweis University, Budapest, Hungary.'}]",Journal of child neurology,['10.1177/0883073818821035']
1924,32438659,The Effects of Two Intervention Strategies to Reduce the Intake of Salt and the Sodium-To-Potassium Ratio on Cardiovascular Risk Factors. A 4-Month Randomised Controlled Study among Healthy Families.,"The aim was to examine the effects of two different salt reduction strategies on selected cardiovascular risk factors. The study was a four-month cluster randomised controlled study. Eighty-nine healthy Danish families (309 individuals) were randomly assigned to either (A) gradually salt-reduced bread, (B) gradually salt-reduced bread and dietary counselling to further reduce salt intake and increase potassium intake or (C) standard bread (control). The effect was assessed using linear mixed models. Intention to treat analyses comparing changes in the three groups showed a significant reduction in body fat percent (-1.31% (-2.40; -0.23)) and a borderline significant reduction in total plasma cholesterol (-0.25 mmol/L (-0.51; 0.01) and plasma renin (-0.19 pmol/L (-0.39; 0.00) in group A compared to the control group. Adjusted complete case analyses showed a significant reduction in total plasma cholesterol (-0.29 mmol/L (-0.50; -0.08), plasma LDL cholesterol (-0.08 mmol/L (-0.15; -0.00)), plasma renin (-0.23 pmol/L (-0.41; -0.05)), plasma adrenaline (-0.03 nmol/L (-0.06; -0.01)) and body fat percent (-1.53% (-2.51; -0.54)) in group A compared to the control group. No significant changes were found in group B compared to the control group. In conclusion, receiving sodium reduce bread was associated with beneficial changes in cardiovascular risk factors. No adverse effects were observed.",2020,Intention to treat analyses comparing changes in the three groups showed a significant reduction in body fat percent (-1.31% (-2.40; -0.23)) and a borderline significant reduction in total plasma cholesterol (-0.25 mmol/L (-0.51; 0.01) and plasma renin (-0.19 pmol/L (-0.39; 0.00) in group A compared to the control group.,"['Healthy Families', 'Eighty-nine healthy Danish families (309 individuals']","['salt reduction strategies', 'Sodium-To-Potassium Ratio', 'salt-reduced bread, (B) gradually salt-reduced bread and dietary counselling to further reduce salt intake and increase potassium intake or (C) standard bread (control']","['total plasma cholesterol', 'plasma renin', 'plasma adrenaline', 'plasma LDL cholesterol', 'cardiovascular risk factors', 'adverse effects', 'body fat percent']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0006138', 'cui_str': 'Bread'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0856882', 'cui_str': 'Potassium increased'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0858034', 'cui_str': 'Plasma cholesterol'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C1278149', 'cui_str': 'Plasma LDL cholesterol measurement'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",89.0,0.0286472,Intention to treat analyses comparing changes in the three groups showed a significant reduction in body fat percent (-1.31% (-2.40; -0.23)) and a borderline significant reduction in total plasma cholesterol (-0.25 mmol/L (-0.51; 0.01) and plasma renin (-0.19 pmol/L (-0.39; 0.00) in group A compared to the control group.,"[{'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Toft', 'Affiliation': 'Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, 2000 Frederiksberg, Denmark.'}, {'ForeName': 'Nanna Louise', 'Initials': 'NL', 'LastName': 'Riis', 'Affiliation': 'Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, 2000 Frederiksberg, Denmark.'}, {'ForeName': 'Anne Dahl', 'Initials': 'AD', 'LastName': 'Lassen', 'Affiliation': 'National Food Institute, Technical University of Denmark, 2800 Kgs. Lyngby, Denmark.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Trolle', 'Affiliation': 'National Food Institute, Technical University of Denmark, 2800 Kgs. Lyngby, Denmark.'}, {'ForeName': 'Anne Helms', 'Initials': 'AH', 'LastName': 'Andreasen', 'Affiliation': 'Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, 2000 Frederiksberg, Denmark.'}, {'ForeName': 'Amalie Kruse Sigersted', 'Initials': 'AKS', 'LastName': 'Frederiksen', 'Affiliation': 'Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, 2000 Frederiksberg, Denmark.'}, {'ForeName': 'Niklas Rye', 'Initials': 'NR', 'LastName': 'Joergensen', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Jens Kristian', 'Initials': 'JK', 'LastName': 'Munk', 'Affiliation': 'Department of Clinical Biochemistry, Amager and Hvidovre Hospital, 2650 Hvidovre, Denmark.'}, {'ForeName': 'Kirsten Schroll', 'Initials': 'KS', 'LastName': 'Bjoernsbo', 'Affiliation': 'Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, 2000 Frederiksberg, Denmark.'}]",Nutrients,['10.3390/nu12051467']
1925,32438338,"A Multilingual, Culturally Competent Mobile Health Intervention to Improve Treatment Adherence Among Women Living With HIV: Protocol for a Randomized Controlled Trial.","BACKGROUND


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


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


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


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


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


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


DERR1-10.2196/17656.",2020,"There is an unmet need for culturally and linguistically appropriate mHealth interventions that address the health care needs of minority women living with HIV (WLWH).
","['54 participants (28 English speakers, 14 Spanish speakers, and 12 Haitian Creole speakers', 'minority women living with HIV (WLWH', 'ethnic minority women', ""Women (aged ≥18 years) followed up at the women's HIV clinic of an academic medical center, with a recent history of nonadherence to HIV care (missed appointments, unsuppressed viral load, or not taking medications as prescribed) will be enrolled"", 'Women Living With HIV']","['Mobile health (mHealth) solutions', 'health reminders and psychoeducational messaging, plus clinic standard of care reminders']","['feasibility and acceptability', ""changes in self-reported medication adherence, depressive symptoms, HIV stigma, medical mistrust, resilience, and clinic attendance and viral suppression extracted from the participants' medical records""]","[{'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C1290952', 'cui_str': 'Taking medication'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0025102', 'cui_str': 'Medical record'}]",54.0,0.132302,"There is an unmet need for culturally and linguistically appropriate mHealth interventions that address the health care needs of minority women living with HIV (WLWH).
","[{'ForeName': 'Lunthita M', 'Initials': 'LM', 'LastName': 'Duthely', 'Affiliation': 'Obstetrics, Gynecology and Reproductive Services, Miller School of Medicine, University of Miami, Miami, FL, United States.'}, {'ForeName': 'Alex P', 'Initials': 'AP', 'LastName': 'Sanchez-Covarrubias', 'Affiliation': 'Miami Clinical and Translational Sciences Institute, Miller School of Medicine, University of Miami, Miami, FL, United States.'}, {'ForeName': 'Adhar B', 'Initials': 'AB', 'LastName': 'Mohamed', 'Affiliation': 'Obstetrics, Gynecology and Reproductive Services, Miller School of Medicine, University of Miami, Miami, FL, United States.'}, {'ForeName': 'JoNell E', 'Initials': 'JE', 'LastName': 'Potter', 'Affiliation': 'Obstetrics, Gynecology and Reproductive Services, Miller School of Medicine, University of Miami, Miami, FL, United States.'}]",JMIR research protocols,['10.2196/17656']
1926,29194102,Neurocognitive Profiling of Adult Treatment Seekers Enrolled in a Clinical Trial of a Web-delivered Intervention for Substance Use Disorders.,"OBJECTIVE


This study is a secondary descriptive analysis that explores and compares the cognitive profiles of adults entering treatment at geographically diverse community-based substance use disorder treatment facilities.
METHODS


Performance on cognitive measures at baseline was compared across 5 primary substance subgroups of individuals (alcohol = 104; cocaine = 102; stimulants = 69; opioids = 108; marijuana = 114) enrolled in a web-based psychosocial treatment study conducted within the National Drug Abuse Treatment Clinical Trials Network. MicroCog subtests were used to assess cognitive domains of attention and mental control, reasoning and cognitive flexibility, and spatial processing.
RESULTS


The average age of onset for a substance use disorder was early to mid-20s, with marijuana users reporting the earliest age of onset (mean 19.9, SD 7.5) and stimulant users reporting the latest (mean 25.2, SD 9.9). Among the total sample, half (49.7%) demonstrated impairment in cognitive flexibility and reasoning, and over one-third (37.3%) had impairment in verbal learning and memory. Stimulant (37.68%) and cocaine (34.31%) users showed significantly greater clinical impairment in attention and mental control compared with alcohol users (17.31%) and opioid (21.30%) users (stimulant subgroup only) (χ [4] = 10.97, P = 0.027). Cocaine users showed the greatest overall impairment across total and proficiency subtest scores, although these were not statistically different from other subgroups.
CONCLUSIONS


These findings confirmed previous studies, indicating a high prevalence of significant cognitive dysfunction across all substance use categories among treatment-seeking adults, and found that cocaine use appears to be associated with the most impairment. Increasing knowledge of similarities and differences between primary substance subgroups can help guide substance use disorder treatment planning.",2018,"users showed significantly greater clinical impairment in attention and mental control compared with alcohol users (17.31%) and opioid (21.30%) users (stimulant subgroup only) (χ [4] = 10.97, P = 0.027).","['marijuana users reporting the earliest age of onset (mean 19.9, SD 7.5) and stimulant users reporting the latest (mean 25.2, SD 9.9', 'adults entering treatment at geographically diverse community-based substance use disorder treatment facilities', '5 primary substance subgroups of individuals (alcohol\u200a=\u200a104; cocaine\u200a=\u200a102; stimulants\u200a=\u200a69; opioids\u200a=\u200a108; marijuana\u200a=\u200a114) enrolled in a web-based psychosocial treatment study conducted within the National Drug Abuse Treatment Clinical Trials Network', 'Adult Treatment Seekers Enrolled in a Clinical Trial of a Web-delivered Intervention for Substance Use Disorders']","['cocaine', 'Cocaine']","['impairment in cognitive flexibility and reasoning', 'cognitive domains of attention and mental control, reasoning and cognitive flexibility, and spatial processing', 'clinical impairment in attention and mental control', 'overall impairment across total and proficiency subtest scores', 'verbal learning and memory']","[{'cui': 'C4518790', 'cui_str': 'Marijuana user (finding)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0013146', 'cui_str': 'Drug abuse (disorder)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0009170', 'cui_str': 'Cocaine'}]","[{'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3850026', 'cui_str': 'Auditory Spatial Processing'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0042531', 'cui_str': 'Verbal Learning'}, {'cui': 'C0025260', 'cui_str': 'Memory'}]",,0.0560987,"users showed significantly greater clinical impairment in attention and mental control compared with alcohol users (17.31%) and opioid (21.30%) users (stimulant subgroup only) (χ [4] = 10.97, P = 0.027).","[{'ForeName': 'Efrat', 'Initials': 'E', 'LastName': 'Aharonovich', 'Affiliation': 'New York State Psychiatric Institute, New York, NY (EA, ANCC, MS, EVN); Department of Psychiatry, Columbia University Medical Center, New York, NY (EA, ANCC, MS, M-CH, EVN); Aspire Health Partners, Orlando, FL (TK); Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, OH (TW).'}, {'ForeName': 'Aimee N C', 'Initials': 'ANC', 'LastName': 'Campbell', 'Affiliation': ''}, {'ForeName': 'Matisyahu', 'Initials': 'M', 'LastName': 'Shulman', 'Affiliation': ''}, {'ForeName': 'Mei-Chen', 'Initials': 'MC', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Kyle', 'Affiliation': ''}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': ''}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': ''}]",Journal of addiction medicine,['10.1097/ADM.0000000000000372']
1927,32495114,Effects of Continuous Theta Burst Stimulation Over the Left Dlpfc on Mother Tongue and Second Language Production In Late Bilinguals: A Behavioral and ERP Study.,"Clinical, neuroimaging, and non-invasive brain stimulation studies have associated the dorsolateral prefrontal cortex (DLPFC) with the multilingual language control system. Here, we investigated if this role is increased during the processing of the non-dominant language due to the higher cognitive/attentional demands. We used an inhibitory repetitive transcranial magnetic stimulation (rTMS) protocol over the left DLPFC and investigated the behavioral and electrophysiological effects on (i) picture naming in the mother tongue and second language, (ii) forward and backward translation and (iii) non-verbal inhibition. To this end, we compared the effects of inhibitory rTMS (cTBS) vs sham-rTMS using a single-blind within-subject design including 22 late bilinguals. Behaviorally, response times were longer after cTBS compared to sham-rTMS in the picture naming task independent of language, while response times were not affected for the word translation task. These results were mirrored on the electrophysiological level showing an effect of stimulation in the picture naming task starting at 547 ms post-stimulus onset, but not in the translation task. This late time range is likely associated with processes of conflict resolution and initiation of the articulation of the word rather than processes related to lexical selection or language switching. For the non-verbal inhibition task, behavioral outcome was not affected despite electrophysiological stimulation-induced changes. Overall, the results suggest that the DLPFC plays a role in top-down cognitive control in language production, but that this role is not increased with higher cognitive demand such as naming in a second language or in language switching during word translation.",2020,"Behaviorally, response times were longer after cTBS compared to sham-rTMS in the picture naming task independent of language, while response times were not affected for the word translation task.",['In Late Bilinguals'],"['inhibitory rTMS (cTBS) vs sham-rTMS', 'inhibitory repetitive transcranial magnetic stimulation (rTMS) protocol', 'Continuous Theta Burst Stimulation']","['behavioral and electrophysiological effects on (i) picture naming in the mother tongue and second language, (ii) forward and backward translation and (iii) non-verbal inhibition', 'Mother Tongue and Second Language Production']","[{'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0557072', 'cui_str': 'Mother tongue'}, {'cui': 'C0557074', 'cui_str': 'Second language'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",,0.033267,"Behaviorally, response times were longer after cTBS compared to sham-rTMS in the picture naming task independent of language, while response times were not affected for the word translation task.","[{'ForeName': 'Lea B', 'Initials': 'LB', 'LastName': 'Jost', 'Affiliation': 'Laboratory for Cognitive and Neurological Sciences, Neurology Unit, Department of Neuroscience and Movement Science, Faculty of Science and Medicine, University of Fribourg, Ch. du Musée 5, CH-1700, Fribourg, Switzerland. lea.jost@unifr.ch.'}, {'ForeName': 'Maria I', 'Initials': 'MI', 'LastName': 'Pestalozzi', 'Affiliation': 'Laboratory for Cognitive and Neurological Sciences, Neurology Unit, Department of Neuroscience and Movement Science, Faculty of Science and Medicine, University of Fribourg, Ch. du Musée 5, CH-1700, Fribourg, Switzerland.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Cazzoli', 'Affiliation': 'Gerontechnology and Rehabilitation Group, ARTORG Center for Biomedical Engineering Research, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mouthon', 'Affiliation': 'Laboratory for Cognitive and Neurological Sciences, Neurology Unit, Department of Neuroscience and Movement Science, Faculty of Science and Medicine, University of Fribourg, Ch. du Musée 5, CH-1700, Fribourg, Switzerland.'}, {'ForeName': 'René M', 'Initials': 'RM', 'LastName': 'Müri', 'Affiliation': 'Gerontechnology and Rehabilitation Group, ARTORG Center for Biomedical Engineering Research, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Annoni', 'Affiliation': 'Laboratory for Cognitive and Neurological Sciences, Neurology Unit, Department of Neuroscience and Movement Science, Faculty of Science and Medicine, University of Fribourg, Ch. du Musée 5, CH-1700, Fribourg, Switzerland.'}]",Brain topography,['10.1007/s10548-020-00779-0']
1928,32438483,Telemonitoring versus standard care in heart failure: a randomised multicentre trial.,"AIMS


The aim was to assess the effect of a telemonitoring programme vs. standard care (SC) in preventing all-cause deaths or unplanned hospitalisations in heart failure (HF) at 18 months.
METHODS AND RESULTS


OSICAT was a randomised, multicentre, open-label French study in 937 patients hospitalised for acute HF ≤12 months before inclusion. Patients were randomised to telemonitoring (daily body weight measurement, daily recording of HF symptoms, and personalised education) (n = 482) or to SC (n = 455). Mean ± standard deviation number of events for the primary outcome was 1.30 ± 1.85 for telemonitoring and 1.46 ± 1.98 for SC [rate ratio 0.97, 95% confidence interval (CI) 0.77-1.23; P = 0.80]. In New York Heart Association (NYHA) class III or IV HF, median time to all-cause death or first unplanned hospitalisation was 82 days in the telemonitoring group and 67 days in the SC group (P = 0.03). After adjustment for known predictive factors, telemonitoring was associated with a 21% relative risk reduction in first unplanned hospitalisation for HF [hazard ratio (HR) 0.79, 95% CI 0.62-0.99; P = 0.044); the relative risk reduction was 29% in patients with NYHA class III or IV HF (HR 0.71, 95% CI 0.53-0.95; P = 0.02), 38% in socially isolated patients (HR 0.62, 95% CI 0.39-0.98; P = 0.043), and 37% in patients who were ≥70% adherent to body weight measurement (HR 0.63, 95% CI 0.45-0.88; P = 0.006).
CONCLUSION


Telemonitoring did not result in a significantly lower rate of all-cause deaths or unplanned hospitalisations in HF patients. The pre-specified subgroup results suggest the telemonitoring approach improves clinical outcomes in selected populations but need further confirmation.",2020,Telemonitoring did not result in a significantly lower rate of all-cause deaths or unplanned hospitalisations in HF patients.,"['all-cause deaths or unplanned hospitalisations in heart failure (HF) at 18\u2009months', '937 patients hospitalised for acute HF ≤12\u2009months before inclusion', 'in heart failure']","['telemonitoring (daily body-weight measurement, daily recording of HF symptoms, and personalised education) (n\xa0=\xa0482) or to SC', 'telemonitoring programme versus standard care (SC', 'Telemonitoring versus standard of care']","['Mean\u2009±\u2009standard deviation number of events', 'median time to all-cause death or first unplanned hospitalisation', 'rate of all-cause deaths or unplanned hospitalisations', 'relative risk reduction']","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",937.0,0.224831,Telemonitoring did not result in a significantly lower rate of all-cause deaths or unplanned hospitalisations in HF patients.,"[{'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Galinier', 'Affiliation': 'Cardiology, Toulouse Rangueil University Hospital (CHU), Toulouse, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Roubille', 'Affiliation': 'PhyMedExp, Université de Montpellier, INSERM, CNRS, Cardiology Department, University Hospital of Montpellier, Montpellier, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Berdague', 'Affiliation': 'Beziers Hospital Centre, Beziers, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Brierre', 'Affiliation': ""Intercommunal Hospital Centre des Vallées de l'Ariege, Foix, France.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Cantie', 'Affiliation': 'Intercommunal Hospital Centre Castres-Mazamet, Castres, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Dary', 'Affiliation': 'Private Practice, Saint Yrieix La Perche, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Ferradou', 'Affiliation': 'Cardiology Aftercare and Rehabilitation Centre, Beaumont de Lomagne, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Fondard', 'Affiliation': 'Pasteur Clinic, Toulouse, France.'}, {'ForeName': 'Jean Philippe', 'Initials': 'JP', 'LastName': 'Labarre', 'Affiliation': 'Pont de Chaume Clinic, Montauban, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Mansourati', 'Affiliation': 'CHRU Brest, Brest, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Picard', 'Affiliation': ""Unité d'Insuffisance Cardiaque, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France.""}, {'ForeName': 'Jean-Etienne', 'Initials': 'JE', 'LastName': 'Ricci', 'Affiliation': 'University Hospital of Nimes, Nimes, France.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Salvat', 'Affiliation': 'University Hospital of Grenoble, Grenoble, France.'}, {'ForeName': 'Lamia', 'Initials': 'L', 'LastName': 'Tartière', 'Affiliation': 'Leon Berard Hospital, Hyeres, France.'}, {'ForeName': 'Jean-Bernard', 'Initials': 'JB', 'LastName': 'Ruidavets', 'Affiliation': 'INSERM UMR - U1027, Toulouse, France.'}, {'ForeName': 'Vanina', 'Initials': 'V', 'LastName': 'Bongard', 'Affiliation': 'USMR - CHU Toulouse, Toulouse, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Delval', 'Affiliation': 'Air Liquide Santé International, Loges en Josas, France.'}, {'ForeName': 'Guila', 'Initials': 'G', 'LastName': 'Lancman', 'Affiliation': 'Air Liquide Santé International, Loges en Josas, France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Pasche', 'Affiliation': 'Air Liquide Santé International, Loges en Josas, France.'}, {'ForeName': 'Juan Fernando', 'Initials': 'JF', 'LastName': 'Ramirez-Gil', 'Affiliation': 'Air Liquide Santé International, Loges en Josas, France.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Pathak', 'Affiliation': 'Department of Cardiovascular Medicine, Princess Grace Hospital, Monaco, Monaco.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of heart failure,['10.1002/ejhf.1906']
1929,32438719,"Effect of a Combination of Citrus Flavones and Flavanones and Olive Polyphenols for the Reduction of Cardiovascular Disease Risk: An Exploratory Randomized, Double-Blind, Placebo-Controlled Study in Healthy Subjects.","A single-center, randomized, double-blind controlled trial was conducted to assess the efficacy of a food supplement based on a combination of grapefruit, bitter orange, and olive extracts administered for eight weeks (n = 51) versus placebo (n = 45) on reduction of cardiovascular risk in healthy volunteers. Study variables included flow-mediated vasodilation (FMD), blood pressure (BP), lipid profile, thrombotic status, oxidative stress biomarkers, inflammation-related biomarkers, anthropometric variables, quality of life, and physical activity. The per-protocol data set was analyzed. In the active product group, there were statistically significant within-group differences at eight weeks as compared with baseline in FMD, systolic and diastolic BP, total cholesterol, LDL-C, LDL-oxidase, oxidized/reduced glutathione ratio, protein carbonyl, and IL-6. Significant between-group differences in these variables were also found. Significant changes in anthropometric variables and quality of life were not observed in the study groups. Changes in the level of physical activity were not recorded. Treatment with the active product was well tolerated. All these findings, taken together, support a beneficial effect of supplementation with a mixture of grapefruit, bitter orange fruits, and olive leaf extracts on underlying mechanisms that may interact each other to decrease the cardiovascular risk in healthy people.",2020,"In the active product group, there were statistically significant within-group differences at eight weeks as compared with baseline in FMD, systolic and diastolic BP, total cholesterol, LDL-C, LDL-oxidase, oxidized/reduced glutathione ratio, protein carbonyl, and","['healthy volunteers', 'healthy people', 'Healthy Subjects']","['placebo', 'Placebo', 'Citrus Flavones and Flavanones and Olive Polyphenols', 'grapefruit, bitter orange, and olive extracts']","['flow-mediated vasodilation (FMD), blood pressure (BP), lipid profile, thrombotic status, oxidative stress biomarkers, inflammation-related biomarkers, anthropometric variables, quality of life, and physical activity', 'cardiovascular risk', 'FMD, systolic and diastolic BP, total cholesterol, LDL-C, LDL-oxidase, oxidized/reduced glutathione ratio, protein carbonyl, and', 'tolerated', 'Cardiovascular Disease Risk', 'level of physical activity', 'anthropometric variables and quality of life']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008865', 'cui_str': 'Citrus'}, {'cui': 'C0016219', 'cui_str': '2-Phenyl-2-Ene-Benzopyran-4-One Compounds'}, {'cui': 'C0060425', 'cui_str': 'flavanone'}, {'cui': 'C0228539', 'cui_str': 'Olivary nucleus structure'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0440280', 'cui_str': 'GRAPEFRUIT EXTRACT'}, {'cui': 'C0330922', 'cui_str': 'Citrus aurantium'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0242417', 'cui_str': 'Oxidase'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.237868,"In the active product group, there were statistically significant within-group differences at eight weeks as compared with baseline in FMD, systolic and diastolic BP, total cholesterol, LDL-C, LDL-oxidase, oxidized/reduced glutathione ratio, protein carbonyl, and","[{'ForeName': 'Maravillas', 'Initials': 'M', 'LastName': 'Sánchez Macarro', 'Affiliation': 'Health Sciences Department, Universidad Católica San Antonio de Murcia (UCAM), Campus de los Jerónimos, E-30107 Murcia, Spain.'}, {'ForeName': 'Juan Pablo', 'Initials': 'JP', 'LastName': 'Martínez Rodríguez', 'Affiliation': 'Health Sciences Ph.D. Program, Universidad Católica San Antonio de Murcia (UCAM), Campus de los Jerónimos, E-30107 Murcia, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Bernal Morell', 'Affiliation': 'Unidad de Enfermedades Infecciosas, Hospital General Universitario Reina Sofia, E-30003 Murcia, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Pérez-Piñero', 'Affiliation': 'Health Sciences Department, Universidad Católica San Antonio de Murcia (UCAM), Campus de los Jerónimos, E-30107 Murcia, Spain.'}, {'ForeName': 'Desirée', 'Initials': 'D', 'LastName': 'Victoria-Montesinos', 'Affiliation': 'Health Sciences Department, Universidad Católica San Antonio de Murcia (UCAM), Campus de los Jerónimos, E-30107 Murcia, Spain.'}, {'ForeName': 'Ana María', 'Initials': 'AM', 'LastName': 'García-Muñoz', 'Affiliation': 'Health Sciences Department, Universidad Católica San Antonio de Murcia (UCAM), Campus de los Jerónimos, E-30107 Murcia, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Cánovas García', 'Affiliation': 'Health Sciences Department, Universidad Católica San Antonio de Murcia (UCAM), Campus de los Jerónimos, E-30107 Murcia, Spain.'}, {'ForeName': 'Julián', 'Initials': 'J', 'LastName': 'Castillo Sánchez', 'Affiliation': 'Research and Development Department, Nutrafur iff-Health, E-30820 Murcia, Spain.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'López-Román', 'Affiliation': 'Health Sciences Department, Universidad Católica San Antonio de Murcia (UCAM), Campus de los Jerónimos, E-30107 Murcia, Spain.'}]",Nutrients,['10.3390/nu12051475']
1930,32438250,Ante-and post-mortem strategies to improve the meat quality of high-value muscles harvested from farmed male common eland (Taurotragus oryx).,"The effects of immunocastration, pelvic suspension and wet ageing on the meat quality of the longissimus lumborum et thoracis (LTL) and biceps femoris (BF) muscles of male common eland were evaluated. Ten subadult males were either immunocastrated (n = 5) or remained intact (n = 5) throughout a four-month growth trial, after which their carcass sides were randomly allocated to either pelvic- or Achilles-suspension. The LTL and BF were further aged for 14 days, measuring changes in the physical quality weekly. The sensory quality of the LTL and BF were determined after ageing (8/9 days, respectively). Immunocastration had minimal effects on the meat quality of male eland, but pelvic suspension decreased the shear force. All muscles reached minimum shear force after seven days of ageing, and the panellists ranked the pelvic-suspended muscles higher for tenderness traits. Incorporating pelvic suspension and wet ageing into the commercial processing of eland carcasses should be considered to improve overall meat quality.",2020,"Immunocastration had minimal effects on the meat quality of male eland, but pelvic suspension decreased the shear force.","['Ten subadult males were either immunocastrated (n\xa0=\xa05) or remained intact (n\xa0=\xa05) throughout a four-month growth trial, after which their carcass sides', 'high-value muscles harvested from farmed male common eland (Taurotragus oryx']","['pelvic- or Achilles-suspension', 'immunocastration, pelvic suspension and wet ageing']","['meat quality of the longissimus lumborum et thoracis (LTL) and biceps femoris (BF) muscles', 'sensory quality of the LTL and BF', 'overall meat quality']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0441987', 'cui_str': 'Side'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0325245', 'cui_str': 'Taurotragus oryx'}]","[{'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0205381', 'cui_str': 'Wet'}]","[{'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0224306', 'cui_str': 'Structure of longissimus muscle'}, {'cui': 'C0224449', 'cui_str': 'Biceps femoris muscle structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",10.0,0.0142914,"Immunocastration had minimal effects on the meat quality of male eland, but pelvic suspension decreased the shear force.","[{'ForeName': 'Tersia', 'Initials': 'T', 'LastName': 'Needham', 'Affiliation': 'Department of Animal Science and Food Processing, Faculty of Tropical AgriSciences, Czech University of Life Sciences Prague, Kamýcká 129, Prague, Suchdol 165 00, Czech Republic. Electronic address: needham@ftz.czu.cz.'}, {'ForeName': 'Radim', 'Initials': 'R', 'LastName': 'Kotrba', 'Affiliation': 'Department of Animal Science and Food Processing, Faculty of Tropical AgriSciences, Czech University of Life Sciences Prague, Kamýcká 129, Prague, Suchdol 165 00, Czech Republic; Department of Ethology, Institute of Animal Science, Přátelství 815, Prague 10- Uhříněves, 104 00, Czech Republic.'}, {'ForeName': 'Louwrens C', 'Initials': 'LC', 'LastName': 'Hoffman', 'Affiliation': 'Department of Animal Sciences, University of Stellenbosch, Private Bag X1, Matieland, Stellenbosch 7602, South Africa; Centre for Nutrition and Food Sciences, Queensland Alliance for Agriculture and Food Innovation (QAAFI), The University of Queensland, Health and Food Sciences Precinct, 39 Kessels Rd, Coopers Plains 4108. Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bureš', 'Affiliation': 'Department of Cattle Breeding, Institute of Animal Science, Přátelství 815, Prague 10- Uhříněves, 104 00, Czech Republic; Department of Food Quality, Faculty of Agrobiology, Food and Natural Sciences, Czech University of Life Sciences Prague, Kamýcká 129, Prague, Suchdol 165 00, Czech Republic.'}]",Meat science,['10.1016/j.meatsci.2020.108183']
1931,32438267,Effect of exercise on knee joint contact forces in people following medial partial meniscectomy: A secondary analysis of a randomised controlled trial.,"BACKGROUND


Arthroscopic partial meniscectomy may cause knee osteoarthritis, which may be related to altered joint loading. Previous research has failed to demonstrate that exercise can reduce medial compartment knee loads following meniscectomy but has not considered muscular loading in their estimates.
RESEARCH QUESTION


What is the effect of exercise compared to no intervention on peak medial tibiofemoral joint contact force during walking using an electromyogram-driven neuromusculoskeletal model, following medial arthroscopic partial meniscectomy?
METHODS


This is a secondary analysis of a randomized controlled trial (RCT). 41 participants aged between 30-50 years with medial arthroscopic partial meniscectomy within the past 3-12 months, were randomly allocated to either a 12-week, home-based, physiotherapist-guided exercise program or to no exercise (control group). Three-dimensional lower-body motion, ground reaction forces, and surface electromyograms from eight lower-limb muscles were acquired during self-selected normal- and fast-paced walking at baseline and follow-up. An electromyogram-driven neuromusculoskeletal model estimated medial compartment contact forces (body weight). Linear regression models evaluated between-group differences (mean difference (95% CI)).
RESULTS


There were no significant between-group differences in the change (follow-up minus baseline) in first peak medial contact force during self-selected normal- or fast-paced walking (0.07 (-0.08 to 0.23), P = 0.34 and 0.01 (-0.19 to 0.22), P = 0.89 respectively). No significant between-group difference was found for change in second peak medial contact force during normal- or fast-paced walking (0.09 (-0.09 to 0.28), P = 0.31 and 0.02 (-0.17 to 0.22), P = 0.81 respectively). At the individual level, variability was observed for changes in first (range -26.2% to +31.7%) and second (range -46.5% to +59.9%) peak tibiofemoral contact force.
SIGNIFICANCE


This is the first study to apply electromyogram-driven neuromusculoskeletal modelling to an exercise intervention in a RCT. While our results suggest that a 12-week exercise program does not alter peak medial knee loads after meniscectomy, within-participant variability suggests individual-specific muscle activation patterns that warrant further investigation.",2020,"No significant between-group difference was found for change in second peak medial contact force during normal- or fast-paced walking (0.09 (-0.09 to 0.28), P = 0.31 and 0.02","['41 participants aged between 30-50 years with medial arthroscopic partial meniscectomy within the past 3-12 months', 'people following medial partial meniscectomy']","['exercise intervention', 'physiotherapist-guided exercise program or to no exercise (control group', 'exercise']","['knee joint contact forces', 'peak medial knee loads', 'change in second peak medial contact force during normal- or fast-paced walking', 'peak tibiofemoral contact force', 'peak medial contact force during self-selected normal- or fast-paced walking']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0187901', 'cui_str': 'Chondrectomy of semilunar cartilage of knee'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",41.0,0.0930649,"No significant between-group difference was found for change in second peak medial contact force during normal- or fast-paced walking (0.09 (-0.09 to 0.28), P = 0.31 and 0.02","[{'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Starkey', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Gavin K', 'Initials': 'GK', 'LastName': 'Lenton', 'Affiliation': 'Gold Coast Orthopaedics Research, Engineering and Education Alliance, Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Saxby', 'Affiliation': 'Gold Coast Orthopaedics Research, Engineering and Education Alliance, Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Rana S', 'Initials': 'RS', 'LastName': 'Hinman', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Kim L', 'Initials': 'KL', 'LastName': 'Bennell', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Wrigley', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, University of Melbourne, Victoria, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lloyd', 'Affiliation': 'Gold Coast Orthopaedics Research, Engineering and Education Alliance, Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, University of Melbourne, Victoria, Australia. Electronic address: halm@unimelb.edu.au.'}]",Gait & posture,['10.1016/j.gaitpost.2020.04.025']
1932,30396226,The Impact of Aspirin on Ultrasound Markers of Uteroplacental Flow in Low-Risk Pregnancy: Secondary Analysis of a Multicenter RCT.,"OBJECTIVE


This article evaluates the effect of low-dose aspirin on uterine artery (UtA) Doppler, placental volume, and vascularization flow indices in low-risk pregnancy.
STUDY DESIGN


In this secondary analysis of the TEST randomized controlled trial, low-risk nulliparous women were originally randomized at 11 weeks to: (1) routine aspirin 75 mg; (2) no aspirin; and (3) aspirin based upon the preeclampsia Fetal Medicine Foundation screening test. UtA Doppler, three-dimensional (3D) placental volume, and vascularization flow indices were assessed prior to and 6 weeks postaspirin commencement.
RESULTS


A total of 546 women were included (aspirin  n  = 192, no aspirin  n  = 354). Between first and second trimesters, aspirin use was not associated with a change in UtA Doppler, placental volume, or vascular flow indices. There was no significant difference in the change in UtA Doppler pulsatility index (PI)  Z -scores or notching (PI  Z -score -0.2 vs. -0.2,  p  = 0.17), nor was there a significant change in placental volume  Z -score and vascular flow indices (volume  Z -score change: 0.74 vs. 0.62,  p  = 0.34).
CONCLUSION


Low-dose aspirin commenced at 11 weeks in low-risk women does not appear to improve uterine and placental perfusion or placental volume. Any perceived effect on uteroplacental vasculature is not reflected in changes in placental volume nor uteroplacental flow as assessed by two-dimensional and 3D ultrasound.",2019,"There was no significant difference in the change in UtA Doppler pulsatility index (PI)  Z -scores or notching (PI  Z -score -0.2 vs. -0.2,  p  = 0.17), nor was there a significant change in placental volume  Z -score and vascular flow indices (volume  Z -score change: 0.74 vs. 0.62,  p  = 0.34).
","['low-risk nulliparous women', 'A total of 546 women were included (aspirin  n \u2009=\u2009192, no aspirin  n \u2009=\u2009354', 'low-risk pregnancy', 'Low-Risk Pregnancy']","['routine aspirin 75\u2009mg; (2) no aspirin; and (3) aspirin based upon the preeclampsia Fetal Medicine Foundation screening test', 'aspirin', 'Low-dose aspirin', 'Aspirin', 'low-dose aspirin']","['change in UtA Doppler, placental volume, or vascular flow indices', 'uterine artery (UtA) Doppler, placental volume, and vascularization flow indices', 'UtA Doppler, three-dimensional (3D) placental volume, and vascularization flow indices', 'UtA Doppler pulsatility index (PI)  Z -scores or notching', 'uterine and placental perfusion or placental volume', 'placental volume  Z -score and vascular flow indices']","[{'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C1454756', 'cui_str': 'NO-aspirin'}, {'cui': 'C0404841', 'cui_str': 'Low risk pregnancy (finding)'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0983879', 'cui_str': 'Aspirin 75 MG'}, {'cui': 'C1454756', 'cui_str': 'NO-aspirin'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1318003', 'cui_str': 'Uta'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0226378', 'cui_str': 'Uterine Artery'}, {'cui': 'C0027686', 'cui_str': 'Pathologic Neovascularization'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]",546.0,0.102546,"There was no significant difference in the change in UtA Doppler pulsatility index (PI)  Z -scores or notching (PI  Z -score -0.2 vs. -0.2,  p  = 0.17), nor was there a significant change in placental volume  Z -score and vascular flow indices (volume  Z -score change: 0.74 vs. 0.62,  p  = 0.34).
","[{'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Mulcahy', 'Affiliation': 'Department of Fetal Medicine, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'Fionnuala', 'Initials': 'F', 'LastName': 'Mone', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, National Maternity Hospital, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'McParland', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, National Maternity Hospital, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Fionnuala', 'Initials': 'F', 'LastName': 'Breathnach', 'Affiliation': 'Department of Obstetrics and Gynaecology, Royal College of Surgeons in Ireland, Rotunda Hospital, Dublin, Ireland.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Cody', 'Affiliation': 'Department of Obstetrics and Gynaecology, Royal College of Surgeons in Ireland, Rotunda Hospital, Dublin, Ireland.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Morrison', 'Affiliation': 'Department of Obstetrics and Gynaecology, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Higgins', 'Affiliation': 'Department of Obstetrics and Gynaecology, University College Cork, Cork, Ireland.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Daly', 'Affiliation': ""Department of Obstetrics and Gynaecology, Coombe Women's and Infant's University Hospital, Dublin, Ireland.""}, {'ForeName': 'Samina', 'Initials': 'S', 'LastName': 'Dornan', 'Affiliation': 'Royal Jubilee Maternity Hospital, Belfast, United Kingdom.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Cotter', 'Affiliation': 'Department of Obstetrics and Gynaecology, Graduate Entry Medical School, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Dicker', 'Affiliation': 'Department of Obstetrics and Gynaecology, Royal College of Surgeons in Ireland, Rotunda Hospital, Dublin, Ireland.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Tully', 'Affiliation': 'Department of Obstetrics and Gynaecology, Royal College of Surgeons in Ireland, Rotunda Hospital, Dublin, Ireland.'}, {'ForeName': 'Fergal D', 'Initials': 'FD', 'LastName': 'Malone', 'Affiliation': 'Department of Obstetrics and Gynaecology, Royal College of Surgeons in Ireland, Rotunda Hospital, Dublin, Ireland.'}, {'ForeName': 'Fionnuala M', 'Initials': 'FM', 'LastName': 'McAuliffe', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, National Maternity Hospital, University College Dublin, Dublin, Ireland.'}]",American journal of perinatology,['10.1055/s-0038-1675208']
1933,31423649,Delivery room skin-to-skin contact for preterm infants-A randomized clinical trial.,"AIM


To investigate the effects of 60 minutes delivery room skin-to-skin contact (DR-SSC) compared with 5 minutes visual contact (VC) on mother-child interaction (MCI), salivary cortisol, maternal depression, stress and bonding at 6 months corrected age.
METHODS


A single-centre randomized controlled trial conducted in a German level III NICU. Eighty-eight preterm infants (25-32 weeks of gestational age) were randomized after initial stabilization to either 60 minutes DR-SSC or 5 minutes VC. Forty-five infants were allocated to DR-SSC, 43 to VC.
RESULTS


Delivery room skin-to-skin contact dyads showed a higher quantity of maternal motoric (18 vs 15, P = .030), infant's vocal (7 vs 5, P = .044) and motoric (20 vs 15, P = .032) responses. Moreover, the combined score of maternal and infant responsive behaviour was higher (86 vs 71, P = .041) in DR-SSC dyads. DR-SSC mothers had lower risk of both, early postpartum depression (15% vs 45%, P = .003) and impaired bonding (Score 3 vs 5, P = .031).
CONCLUSION


In addition to regular intermittent kangaroo mother care, DR-SSC promotes MCI and decreases risk of maternal depression and bonding problems. Thus, DR-SSC may have positive effects on preterm development.",2020,"Moreover, the combined score of maternal and infant responsive behavior was higher (86 vs 71, p=0.041) in DR-SSC dyads.","['preterm infants ', '45 infants', '88 preterm infants (25 to 32 weeks of gestational age']","['60 minutes delivery room skin-to-skin contact (DR-SSC', 'Delivery room skin-to-skin contact']","['combined score of maternal and infant responsive behavior', 'mother-child interaction (MCI), salivary cortisol, maternal depression, stress, and bonding', 'maternal depression and bonding problems', 'lower risk of both, early postpartum depression', 'quantity of maternal motoric', ""infant's vocal""]","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}]","[{'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0011212', 'cui_str': 'Centers, Hospital Birth'}, {'cui': 'C1123023', 'cui_str': 'Skin'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0026590', 'cui_str': 'Mother-Child Relationship'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0221074', 'cui_str': 'Postnatal Depression'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}]",45.0,0.103115,"Moreover, the combined score of maternal and infant responsive behavior was higher (86 vs 71, p=0.041) in DR-SSC dyads.","[{'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Mehler', 'Affiliation': ""Division of Neonatology, Children's Hospital, University of Cologne, Cologne, Germany.""}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Hucklenbruch-Rother', 'Affiliation': ""Research group of Metabolism and Perinatal Programming, Children's Hospital, University of Cologne, Cologne, Germany.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Trautmann-Villalba', 'Affiliation': 'Institute for Peripartal Interventions, Frankfurt, Germany.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Becker', 'Affiliation': 'Institute of Medical Statistics, Informatics, and Epidemiology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Roth', 'Affiliation': ""Division of Neonatology, Children's Hospital, University of Cologne, Cologne, Germany.""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Kribs', 'Affiliation': ""Division of Neonatology, Children's Hospital, University of Cologne, Cologne, Germany.""}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.14975']
1934,31424431,E-Patient Counseling Trial (E-PACO): Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy.,"Improving patient education focusing on bowel preparation before a colonoscopy leads to cleaner colons. Endoscopy units must obtain informed consent and perform a risk assessment for sedative use prior to a colonoscopy. The current practice in the Netherlands to achieve these goals is nurse counseling in an outpatient setting. This is costly and has disadvantages in terms of uniformity and time consumption for both the patient and the hospital. The hypothesis is that computer-based education with use of video and 3D animations may replace nurse counseling in most cases, without losing quality of bowel cleanliness during colonoscopy. This multicenter, randomized, endoscopist blinded clinical trial evaluates a primary outcome measure (bowel preparation) during colonoscopy. Secondary outcome measures are sickness absence, patient anxiety after instruction and prior to colonoscopy, patient satisfaction and information re-call. The study will be performed in four endoscopy units of different levels (rural, urban, and tertiary). Inclusion criteria are adult age and referral for complete colonoscopy. Exclusion criteria are Dutch illiteracy, audiovisual handicaps or mental disabilities and no (peers with) internet access. This trial aims to establish online computer-based education as tool for patient education prior to a colonoscopy. By choosing a direct comparison with the standard of care (nurse counseling), both endoscopic quality measures and patient related outcome measures can be evaluated.",2019,"Secondary outcome measures are sickness absence, patient anxiety after instruction and prior to colonoscopy, patient satisfaction and information re-call.","['four endoscopy units of different levels (rural, urban, and tertiary', 'Exclusion criteria are Dutch illiteracy, audiovisual handicaps or mental disabilities and no (peers with) internet access', 'patient education prior to a colonoscopy']","['E-Patient Counseling Trial (E-PACO', 'Computer Based Education versus Nurse Counseling']","['sickness absence, patient anxiety after instruction and prior to colonoscopy, patient satisfaction and information re-call']","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0020899', 'cui_str': 'Illiteracy'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C1306341', 'cui_str': 'Mental handicap (finding)'}, {'cui': 'C4704731', 'cui_str': 'Internet Access'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}]","[{'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C1689985', 'cui_str': 'Absence'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}]",,0.0720973,"Secondary outcome measures are sickness absence, patient anxiety after instruction and prior to colonoscopy, patient satisfaction and information re-call.","[{'ForeName': 'Govert', 'Initials': 'G', 'LastName': 'Veldhuijzen', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboud University Medical Center; Govert.Veldhuijzen@radboudumc.nl.'}, {'ForeName': 'Aura A', 'Initials': 'AA', 'LastName': 'van Esch', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboud University Medical Center.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Klemt-Kropp', 'Affiliation': 'Department of Gastroenterology and Hepatology, North West Clinics.'}, {'ForeName': 'Jochim S', 'Initials': 'JS', 'LastName': 'Terhaar Sive Droste', 'Affiliation': 'Department of Gastroenterology and Hepatology, Jeroen Bosch Hospital.'}, {'ForeName': 'Joost P H', 'Initials': 'JPH', 'LastName': 'Drenth', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboud University Medical Center.'}]",Journal of visualized experiments : JoVE,['10.3791/58798']
1935,32438716,Photobiomodulation Therapy on Orthodontic Movement: Analysis of Preliminary Studies with a New Protocol.,"This study aimed to investigate the effectiveness of photobiomodulation therapy (PBMT) on the acceleration of orthodontic movements, deriving from its biostimulating and regenerative capacity on soft tissues, consequent to the increase in differentiation, proliferation, and activity of cells that are involved with alveolar bone remodeling. The present randomized controlled trial was conducted on six patients who required extractive orthodontic therapy because their ectopic canines had erupted. A total of eight canines were analyzed, four of which received laser irradiation (i.e., experimental group). Two weeks after the extractions, all canines of the experimental and placebo groups were distalized simultaneously and symmetrically with the laceback retraction technique. The PBMT protocol consisted of four cycles of laser applications, one each on days 0, 3, 7, and 14 of the study, with session treatment durations of 2-4 min. The results of the descriptive analysis on the distal displacement speed of the canines after 1 month of follow-up indicate an average displacement of 1.35 mm for the non-irradiated group and 1.98 mm for the irradiated group. Through inferential analysis, a statistically significant difference ( p  < 0.05) was found between the average speed of the irradiated canines and the control canines. The low energy density laser used in this study, with the parameters set, was found to be a tool capable of statistically significantly accelerating the distal displacement of canines.",2020,"Through inferential analysis, a statistically significant difference ( p  < 0.05) was found between the average speed of the irradiated canines and the control canines.",['six patients who required extractive orthodontic therapy because their ectopic canines had erupted'],"['Photobiomodulation Therapy', 'photobiomodulation therapy (PBMT', 'laser irradiation', 'placebo']","['distal displacement of canines', 'distal displacement speed']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}]","[{'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]",8.0,0.0304746,"Through inferential analysis, a statistically significant difference ( p  < 0.05) was found between the average speed of the irradiated canines and the control canines.","[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Impellizzeri', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, ""Sapienza"" University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Horodynski', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, ""Sapienza"" University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Fusco', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, ""Sapienza"" University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Gaspare', 'Initials': 'G', 'LastName': 'Palaia', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, ""Sapienza"" University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Polimeni', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, ""Sapienza"" University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Romeo', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, ""Sapienza"" University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Ersilia', 'Initials': 'E', 'LastName': 'Barbato', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, ""Sapienza"" University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Galluccio', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, ""Sapienza"" University of Rome, 00161 Rome, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17103547']
1936,31805396,Nocturnal bilevel positive airway pressure for the treatment of asthma.,"Nocturnal worsening of asthma may be due to reduced lung volumes and fewer sigh breaths, which have been shown to increase airway resistance and bronchoreactivity. We hypothesized that mimicking deep inspiration using nocturnal mechanical support would improve symptoms in patients with asthma. Subjects with asthma underwent usual care and bilevel positive airway pressure (PAP) therapy for 4 weeks, separated by 4 weeks, and methacholine challenge (PC 20 ) and subjective assessments. 13 patients with asthma alone and 8 with asthma + OSA completed the protocol. Change in bronchoreactivity (ratio of Post/Pre PC 20 ) was not significantly different during usual care and bilevel PAP [0.86 (IQR 0.19, 1.82) vs 0.94 (IQR 0.56, 2.5), p = 0.88], nor was the change in Asthma Control Test different: 0.1 ± 2.2 vs. -0.2 ± 2.9, p = 0.79, respectively. Bilevel PAP therapy for four weeks did not improve subjective or objective measures of asthma severity in patients with asthma or those with asthma and OSA, although there was heterogeneity in response.",2020,"Bilevel PAP therapy for four weeks did not improve subjective or objective measures of asthma severity in patients with asthma or those with asthma and OSA, although there was heterogeneity in response.","['patients with asthma', 'Subjects with asthma underwent', '13 patients with asthma alone and 8 with asthma\u202f+\u202fOSA completed the protocol', 'asthma']","['usual care and bilevel positive airway pressure (PAP) therapy', 'Bilevel PAP therapy']","['Change in bronchoreactivity', 'Nocturnal bilevel positive airway pressure', 'subjective or objective measures of asthma severity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C1611149', 'cui_str': 'Bilevel positive airway pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C1611149', 'cui_str': 'Bilevel positive airway pressure'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0581122', 'cui_str': 'Asthma severity (regime/therapy)'}]",,0.0264125,"Bilevel PAP therapy for four weeks did not improve subjective or objective measures of asthma severity in patients with asthma or those with asthma and OSA, although there was heterogeneity in response.","[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Owens', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego, San Diego, CA, United States. Electronic address: rowens@ucsd.edu.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Campana', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Foster', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Schomer', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Israel', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Malhotra', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego, San Diego, CA, United States.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2019.103355']
1937,32495663,Multiple-dose versus single-dose gonadotropin-releasing hormone agonist after first in vitro fertilization failure associated with luteal phase deficiency: A randomized controlled trial.,"OBJECTIVE


To evaluate the efficacy and safety of multiple- versus single-dose gonadotropin-releasing hormone agonist (GnRH-a) addition to luteal phase support (LPS), in patients with a first in vitro fertilization (IVF) failure associated with luteal phase deficiency (LPD).
METHODS


Eighty patients with a first IVF failure associated with LPD were randomly assigned into single-dose and multiple-dose GnRH-a groups. In the second IVF attempt, patients in the single-dose group were given standard LPS plus a single dose of GnRH-a 6 days after oocyte retrieval. Patients in the multiple-dose group received standard LPS plus 14 daily injections of GnRH-a. Children conceived were followed up for 2 years.
RESULTS


Pregnancy (67.5% vs. 42.5%), clinical pregnancy (50.0% vs. 22.5%), and live birth rates (42.5% vs. 20.0%) were significantly higher in the multiple-dose versus single-dose GnRH-a group. Patients in the multiple-dose GnRH-a group had significantly higher progesterone levels 14 days after oocyte recovery (35.9 vs. 21.4 ng/mL). No significant difference existed in the status at birth or developmental and behavior assessments of 2-year-old children conceived in both groups.
CONCLUSIONS


Daily addition of GnRH-a to standard LPS can achieve better pregnancy outcomes with a sustained safety profile in patients with a first IVF failure associated with LPD.",2020,"No significant difference existed in the status at birth or developmental and behavior assessments of 2-year-old children conceived in both groups.
","['patients with a first in vitro fertilization (IVF) failure associated with luteal phase deficiency (LPD', 'vitro fertilization failure associated with luteal phase deficiency', 'patients with a first IVF failure associated with LPD', 'Eighty patients with a first IVF failure associated with LPD']","['multiple- versus single-dose gonadotropin-releasing hormone agonist (GnRH-a) addition to luteal phase support (LPS', 'standard LPS plus 14 daily injections of GnRH-a', 'standard LPS', 'Multiple-dose versus single-dose gonadotropin-releasing hormone agonist']","['live birth rates', 'status at birth or developmental and behavior assessments of 2-year-old children', 'efficacy and safety', 'progesterone levels', 'clinical pregnancy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0404576', 'cui_str': 'Luteal phase defect'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C3816958', 'cui_str': '80'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0024153', 'cui_str': 'Menstrual Cycle, Luteal Phase'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}]","[{'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C1160858', 'cui_str': 'Behavior assessment'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0428409', 'cui_str': 'Progesterone level'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]",80.0,0.0718243,"No significant difference existed in the status at birth or developmental and behavior assessments of 2-year-old children conceived in both groups.
","[{'ForeName': 'Danni', 'Initials': 'D', 'LastName': 'Qu', 'Affiliation': 'Medical Center for Human Reproduction, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Medical Center for Human Reproduction, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.'}]",The Journal of international medical research,['10.1177/0300060520926026']
1938,31411963,Neutrophil-to-lymphocyte Ratio as a Predictive Marker of Response to Abiraterone Acetate: A Retrospective Analysis of the COU302 Study.,"BACKGROUND


The neutrophil-lymphocyte ratio (NLR) is an inexpensive and accessible prognostic marker for many cancers, including metastatic castration-resistant prostate cancer (mCRPC).
OBJECTIVE


In this study, we assess the role of NLR as a predictive biomarker through a retrospective analysis of the pivotal COU302 study of abiraterone acetate (AA) as first-line therapy for men with asymptomatic or minimally symptomatic mCRPC.
DESIGN, SETTING, AND PARTICIPANTS


The COU302 study randomized asymptomatic or minimally symptomatic men with mCRPC to receive AA plus prednisone or prednisone as first-line treatment. Baseline NLR, overall survival, radiographic progression-free survival, and prostate-specific antigen (PSA) progression-free survival were evaluated.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Descriptive statistics, as well as Kaplan-Meier and Cox survival models were used to assess the effect of baseline NLR and changes in NLR on response to AA plus prednisone versus prednisone, with adjustment for important covariates.
RESULTS AND LIMITATIONS


Among the 1082 patients who received treatment, baseline NLR values showed no significant differences according to baseline covariates except for albumin. Baseline variables were similar between dichotomous groups with an NLR cutoff of 2.5, except for a lower proportion of patients with >10 bone metastases in the NLR <2.5 group. Our survival results demonstrate that higher NLR values corresponded to poorer overall survival and PSA response to AA but not to placebo, which was confirmed in our adjusted regression models. No significant differences were seen in time to radiographic progression. In separate analyses, an increase or decrease in NLR by 2 from treatment baseline did not clearly signal subsequent lack of benefit with continued AA.
CONCLUSIONS


Our results suggest that baseline NLR may be able to predict response to AA in men with asymptomatic mCRPC but that changes in NLR during treatment are insufficient to guide treatment. Further validation studies are warranted.
PATIENT SUMMARY


In this report, we look at the ratio of circulating immune cells as a predictor of response to abiraterone acetate (AA), using data from a large trial. Our results suggest that this ratio derived from routinely obtained bloodwork can predict which patients respond better to AA.",2020,"Our survival results demonstrate that higher NLR values corresponded to poorer overall survival and PSA response to AA but not to placebo, which was confirmed in our adjusted regression models.","['The COU302 study randomized asymptomatic or minimally symptomatic men with mCRPC to receive', 'men with asymptomatic or minimally symptomatic mCRPC', '1082 patients']","['prednisone', 'placebo', 'Abiraterone Acetate', 'abiraterone acetate (AA', 'AA plus prednisone or prednisone']","['Kaplan-Meier and Cox survival models', 'Baseline NLR, overall survival, radiographic progression-free survival, and prostate-specific antigen (PSA) progression-free survival', 'time to radiographic progression', 'overall survival and PSA response', 'NLR']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2607886', 'cui_str': 'abiraterone acetate'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0442996', 'cui_str': 'Cox (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}]",1082.0,0.217367,"Our survival results demonstrate that higher NLR values corresponded to poorer overall survival and PSA response to AA but not to placebo, which was confirmed in our adjusted regression models.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Loubersac', 'Affiliation': 'Centre Hospitalier Universitaire Nantes, Nantes, France.'}, {'ForeName': 'Molière', 'Initials': 'M', 'LastName': 'Nguile-Makao', 'Affiliation': 'Oncology Division, Department of Surgery, Faculty of Medicine, Centre Hospitalier Universitaire (CHU) de Québec Research Centre, Université Laval, Québec, QC, Canada.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Pouliot', 'Affiliation': 'Oncology Division, Department of Surgery, Faculty of Medicine, Centre Hospitalier Universitaire (CHU) de Québec Research Centre, Université Laval, Québec, QC, Canada.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Fradet', 'Affiliation': 'Oncology Division, Department of Surgery, Faculty of Medicine, Centre Hospitalier Universitaire (CHU) de Québec Research Centre, Université Laval, Québec, QC, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Toren', 'Affiliation': 'Oncology Division, Department of Surgery, Faculty of Medicine, Centre Hospitalier Universitaire (CHU) de Québec Research Centre, Université Laval, Québec, QC, Canada. Electronic address: paul.toren@crchudequebec.ulaval.ca.'}]",European urology oncology,['10.1016/j.euo.2019.01.009']
1939,32495667,"Efficacy of functional magnetic stimulation in improving upper extremity function after stroke: a randomized, single-blind, controlled study.","OBJECTIVE


To clarify the efficacy of functional magnetic stimulation (FMS) in improving hemiplegic upper extremity function in patients with sub-acute stroke.
METHODS


In this randomized controlled trial, 40 sub-acute stroke patients with hemiplegia were recruited from inpatient wards in the Department of Rehabilitation and randomly assigned to two groups. In the FMS group, magnetic stimulation was applied to extensor muscle groups of the affected upper extremity. In the low-frequency repetitive transcranial magnetic stimulation (LF-rTMS) group, stimulation was applied to the contralesional primary motor cortex. All patients received occupational therapy. Hand and upper extremity motor function was evaluated using the Fugl-Meyer Assessment for upper extremity (FMA-UE), and the Barthel Index (BI) evaluated daily living abilities.
RESULTS


The FMA-UE and BI scores were significantly increased in both groups following stimulation. Furthermore, a significant between-group difference was observed in both FMA-UE and BI scores after 2 weeks of therapy. In the FMS group, 6 of 19 patients regained wrist and finger extension abilities, but only 2 patients regained equivalent motor skills in the LF-rTMS group.
CONCLUSIONS


FMS improves paretic upper extremity function and leads to better recovery of motor activity than LF-rTMS. FMS may be a novel modality to improve motor function.",2020,"Hand and upper extremity motor function was evaluated using the Fugl-Meyer Assessment for upper extremity (FMA-UE), and the Barthel Index (BI) evaluated daily living abilities.
","['40 sub-acute stroke patients with hemiplegia were recruited from inpatient wards in the Department of Rehabilitation and randomly assigned to two groups', 'patients with sub-acute stroke', 'upper extremity function after stroke']","['occupational therapy', 'low-frequency repetitive transcranial magnetic stimulation (LF-rTMS', 'functional magnetic stimulation', 'functional magnetic stimulation (FMS']","['wrist and finger extension abilities', 'FMA-UE and BI scores', 'paretic upper extremity function', 'equivalent motor skills', 'Barthel Index (BI) evaluated daily living abilities']","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",40.0,0.025792,"Hand and upper extremity motor function was evaluated using the Fugl-Meyer Assessment for upper extremity (FMA-UE), and the Barthel Index (BI) evaluated daily living abilities.
","[{'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, The First Hospital of Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Xuncan', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, The First Hospital of Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Yinxing', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, The First Hospital of Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Guoxing', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, The First Hospital of Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, The First Hospital of Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Xueru', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Jiang', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Zhenlan', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, The First Hospital of Jilin University, Changchun, Jilin, China.'}]",The Journal of international medical research,['10.1177/0300060520927881']
1940,32495671,Clinical effectiveness of position management and manual rotation of the fetal position with a U-shaped birth stool for vaginal delivery of a fetus in a persistent occiput posterior position.,"OBJECTIVE


To examine the effects of position management, manual rotation of the fetal position, and using a U-shaped birth stool in primiparous women with a fetus in a persistent occiput posterior position.
METHODS


This was a prospective pilot study of women who delivered at Gansu Provincial Maternity and Child-care Hospital between January and June 2018. The women were divided into the position management ([PM] position management, manual rotation of fetal position, use of a U-shaped birth stool at different stages, and routine nursing) and control groups (position selected by women and routine nursing).
RESULTS


There were 196 women in the PM group and 188 in the control group. There were no significant differences in maternal age, gestational weeks, newborn weight, and the neonatal asphyxia rate between the PM and control groups. The duration of labor was shorter in the PM group than in the control group. Pain and blood loss 2 hours after delivery and the episiotomy rate were significantly lower in the PM group than in the control group.
CONCLUSION


Applying position management, manual rotation of the fetal position, and using a U-shaped birth stool should be considered for women with a fetus in a persistent occiput posterior position.",2020,"Pain and blood loss 2 hours after delivery and the episiotomy rate were significantly lower in the PM group than in the control group.
","['196 women in the PM group and 188 in the control group', 'women who delivered at Gansu Provincial Maternity and Child-care Hospital between January and June 2018', 'primiparous women with a fetus in a persistent occiput posterior position']","['position management and manual rotation of the fetal position with a U-shaped birth stool', 'position management ([PM] position management, manual rotation of fetal position, use of a U-shaped birth stool at different stages, and routine nursing) and control groups (position selected by women and routine nursing', 'position management, manual rotation of the fetal position, and using a U-shaped birth stool']","['maternal age, gestational weeks, newborn weight, and the neonatal asphyxia rate', 'duration of labor', 'Pain and blood loss 2 hours after delivery and the episiotomy rate']","[{'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008067', 'cui_str': 'Puericulture'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0856256', 'cui_str': 'Occiput posterior'}, {'cui': 'C0733755', 'cui_str': 'Position'}]","[{'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C1286298', 'cui_str': 'Position of fetus'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C1443305', 'cui_str': 'Birthing stool'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0024915', 'cui_str': 'Maternal age'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0004045', 'cui_str': 'Asphyxia, in liveborn infant'}, {'cui': 'C0566679', 'cui_str': 'Duration of labor'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}]",,0.0261708,"Pain and blood loss 2 hours after delivery and the episiotomy rate were significantly lower in the PM group than in the control group.
","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Perinatal Center, Gansu Provincial Maternity and Child-care Hospital, Lanzhou, China.'}, {'ForeName': 'Tongying', 'Initials': 'T', 'LastName': 'Yi', 'Affiliation': 'Delivery Room, Gansu Provincial Maternity and Child-care Hospital, Lanzhou, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': 'Perinatal Center, Gansu Provincial Maternity and Child-care Hospital, Lanzhou, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Ministry of Science and Technology Development, Gansu Provincial Maternity and Child-care Hospital, Lanzhou, China.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Perinatal Center, Gansu Provincial Maternity and Child-care Hospital, Lanzhou, China.'}, {'ForeName': 'Yufang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesia Surgery, Gansu Provincial Maternity and Child-care Hospital, Lanzhou, China.'}, {'ForeName': 'Qingmei', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': 'Prenatal Diagnosis Center, Gansu Provincial Maternity and Child-care Hospital, Lanzhou, China.'}, {'ForeName': 'Xiaojuan', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'Prenatal Diagnosis Center, Gansu Provincial Maternity and Child-care Hospital, Lanzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics, Gansu Provincial Maternity and Child-care Hospital, Lanzhou, China.'}, {'ForeName': 'Zhaoyan', 'Initials': 'Z', 'LastName': 'Meng', 'Affiliation': 'Department of Obstetrics, Gansu Provincial Maternity and Child-care Hospital, Lanzhou, China.'}]",The Journal of international medical research,['10.1177/0300060520924275']
1941,32141320,Effect on Overall Health Status With Weightbearing at 2 Weeks vs 6 Weeks After Open Reduction and Internal Fixation of Ankle Fractures.,"BACKGROUND


Ongoing controversy exists on postoperative weightbearing status after open reduction and internal fixation of an ankle fracture. This prospective randomized controlled trial aimed to compare patient-based and physician-based outcomes after early weightbearing at 2 vs 6 weeks postoperatively.
METHODS


Fifty patients with unstable rotational-type ankle fractures were treated operatively with subsequent immobilization in a below-the-knee cast for 2 weeks and were then randomly allocated to 2 groups. The first group had early weightbearing at 2 weeks postoperation and the second group at 6 weeks postoperation. Follow-up included subjective and objective evaluations performed at 2, 6, 12, and 26 weeks postoperatively. The primary outcome was the patient-based general health status as measured with the EuroQol-5D (EQ-5D) scoring system. Secondary outcome was the Olerud and Molander ankle score. Power analysis revealed a study group of 50 patients was needed to show a clinically relevant effect size of 10 points in both EQ-5D visual analog scale (VAS) score and Olerud and Molander score.
RESULTS


Patients in the early weightbearing group had higher mean EQ-5D VAS scores at a 6-week follow-up ( P  = .014) of 77 ± 14 compared to 66 ± 15 for late mobilization. No difference was found at other follow-up points or between groups for physician-based outcome measures. At 26 weeks postoperatively, mean Olerud and Molander ankle scores were similar at 84 ± 16 and 81 ± 17 for mobilization at 2 and 6 weeks postoperation, respectively.
CONCLUSION


Early weightbearing after operative fixation of rotational-type ankle fractures had a clinically relevant and statistically significant benefit in patient-based general health status, as quantified with EQ-5D VAS scores, at 6 weeks postoperation. These results contribute to our understanding of early weightbearing and may encourage consideration of weightbearing at 2 weeks postoperatively in standard protocols.
LEVEL OF EVIDENCE


Therapeutic Level I, prospective randomized controlled trial.",2020,"RESULTS


Patients in the early weightbearing group had higher mean EQ-5D VAS scores at a 6-week follow-up ( P  = .014) of 77 ± 14 compared to 66 ± 15 for late mobilization.",['Fifty patients with unstable rotational-type ankle fractures'],[],"['EQ-5D visual analog scale (VAS) score and Olerud and Molander score', 'patient-based general health status as measured with the EuroQol-5D (EQ-5D) scoring system', 'Overall Health Status', 'mean EQ-5D VAS scores', 'mean Olerud and Molander ankle scores', 'Therapeutic Level', 'Internal Fixation of Ankle Fractures', 'EQ-5D VAS scores', 'Olerud and Molander ankle score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443343', 'cui_str': 'Unstable status (qualifier value)'}, {'cui': 'C0445237', 'cui_str': 'Rotational (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0159877', 'cui_str': 'Ankle Fracture'}]",[],"[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0159877', 'cui_str': 'Ankle Fracture'}]",50.0,0.0959215,"RESULTS


Patients in the early weightbearing group had higher mean EQ-5D VAS scores at a 6-week follow-up ( P  = .014) of 77 ± 14 compared to 66 ± 15 for late mobilization.","[{'ForeName': 'Jonathon', 'Initials': 'J', 'LastName': 'Schubert', 'Affiliation': 'Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Kaj T A', 'Initials': 'KTA', 'LastName': 'Lambers', 'Affiliation': 'Department of Orthopaedic Surgery, Academic Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Kimber', 'Affiliation': 'Department of Orthopaedics, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Denk', 'Affiliation': 'Department of Orthopaedic Surgery, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Cho', 'Affiliation': 'Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Job N', 'Initials': 'JN', 'LastName': 'Doornberg', 'Affiliation': 'Department of Orthopaedic Surgery, Academic Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Ruurd L', 'Initials': 'RL', 'LastName': 'Jaarsma', 'Affiliation': 'Department of Orthopaedics and Trauma Surgery, Flinders University, Adelaide, South Australia, Australia.'}]",Foot & ankle international,['10.1177/1071100720908853']
1942,32234359,The effect of gaming on accommodative and vergence facilities after exposure to virtual reality head-mounted display.,"BACKGROUND


To investigate the change between accommodative and vergence facilities before and after exposure to gaming in a virtual reality (VR) device amongst participants with normal binocular visual function.
METHODS


62 participants between the ages of 18-30 years with normal binocular visual function and inter-pupillary distances between 51 and 70 mm were selected for the study. Spectacle and contact lenses users were excluded. The experimental group (n = 42) was exposed to gaming using Samsung Gear VR(SM -R323) whilst the control group (n = 20) watched a television film projected on a two-dimensional screen at 1 m. Pre-test and post-test binocular amplitude-scaled facilities and vergence facilities were obtained for both groups after exposures of 25 min.
RESULTS


Binocular accommodative facilities for the experimental group had a mean pre-test and post-test facility of 11.14 ± 3.67 cpm and 13.38 ± 3.63 cpm, respectively, after gaming using VR device. The vergence facilities for the experimental group had a mean pre-test and post-test facility of 11.41 ± 3.86 cpm and 15.28 ± 4.93 cpm, respectively, after gaming using a VR device. Binocular accommodative facilities for the control group had a mean pre-test and post-test facility of 11.70 ± 3.2 cpm and 11.95 ± 3.4 cpm, respectively. Vergence facilities for the control group had a mean pre-test and post-test facility of 11.55 ± 6.4 cpm and 11.70 ± 4.9 cpm, respectively. The mean change for binocular accommodative facilities was 2.24 ± 3.43 cpm and 0.25 ± 1.25 cpm for the experimental and control group, respectively. The mean change for vergence facilities was 3.81 ± 3.09 cpm and 0.15 ± 2.72 cpm for the experimental and control group, respectively. Binocular accommodative facilities and vergence facility showed a statistically significant mean increase greater than the control group after gaming using a VR device using an independent t-test (p < 0.05).
CONCLUSION


The results showed that binocular accommodative facilities and vergence facilities increased after 25 min of VR gaming in emmetropic participants under 30 years of age with inter-pupillary distances between 51 mm and 70 mm.",2020,"Binocular accommodative facilities and vergence facility showed a statistically significant mean increase greater than the control group after gaming using a VR device using an independent t-test (p < 0.05).
","['participants with normal binocular visual function', '62 participants between the ages of 18-30 years with normal binocular visual function and inter-pupillary distances between 51 and 70 mm were selected for the study']",[],"['Binocular accommodative facilities', 'mean change for vergence facilities', 'mean change for binocular accommodative facilities', 'Binocular accommodative facilities and vergence facility', 'binocular accommodative facilities and vergence facilities', 'Vergence facilities']","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",62.0,0.0234961,"Binocular accommodative facilities and vergence facility showed a statistically significant mean increase greater than the control group after gaming using a VR device using an independent t-test (p < 0.05).
","[{'ForeName': 'Alvin J', 'Initials': 'AJ', 'LastName': 'Munsamy', 'Affiliation': 'Discipline of Optometry, School of Health Science, University of KwaZulu-Natal, Westville Campus, Durban, South Africa. Electronic address: munsamya1@ukzn.ac.za.'}, {'ForeName': 'Husna', 'Initials': 'H', 'LastName': 'Paruk', 'Affiliation': 'Discipline of Optometry, School of Health Science, University of KwaZulu-Natal, Westville Campus, Durban, South Africa.'}, {'ForeName': 'Bronwyn', 'Initials': 'B', 'LastName': 'Gopichunder', 'Affiliation': 'Discipline of Optometry, School of Health Science, University of KwaZulu-Natal, Westville Campus, Durban, South Africa.'}, {'ForeName': 'Anela', 'Initials': 'A', 'LastName': 'Luggya', 'Affiliation': 'Discipline of Optometry, School of Health Science, University of KwaZulu-Natal, Westville Campus, Durban, South Africa.'}, {'ForeName': 'Thembekile', 'Initials': 'T', 'LastName': 'Majola', 'Affiliation': 'Discipline of Optometry, School of Health Science, University of KwaZulu-Natal, Westville Campus, Durban, South Africa.'}, {'ForeName': 'Sneliswa', 'Initials': 'S', 'LastName': 'Khulu', 'Affiliation': 'Discipline of Optometry, School of Health Science, University of KwaZulu-Natal, Westville Campus, Durban, South Africa.'}]",Journal of optometry,['10.1016/j.optom.2020.02.004']
1943,32495992,"Assessment of Energy and Protein Requirements in Relation to Nitrogen Kinetics, Nutrition, and Clinical Outcomes in Infants Receiving Early Enteral Nutrition Following Cardiopulmonary Bypass.","BACKGROUND


Nutrition therapies in children with congenital heart disease (CHD) after cardiopulmonary bypass (CPB) is crucial, but energy and protein requirements remain undefined. We assessed energy and protein requirements, with nitrogen kinetics and clinical outcomes, in infants with complex CHD following CPB.
METHODS


Infants were randomized to control (1.3 g/kg/d), moderate protein (MP, 2.5 g/kg/d), or high protein (HP, 4 g/kg/d) groups. Resting energy expenditure (REE) was measured 6 hours post-CPB and then at 24-hour intervals, using indirect calorimetry to formulate energy intakes. Enteral formula feeding was initiated 6 hours post-CPB and continued for 5 days. Nitrogen balance (NB); urea nitrogen waste and nitrogen retention; serum prealbumin level; and hepatic, renal, and cardiac function were measured daily. Mid-upper arm circumference and triceps skinfold were measured preoperatively and 5 days after CPB. Adverse outcomes (bacterial infection, reintubation, and cardiac intensive care unit (CICU) stay > 8 days) were recorded.
RESULTS


REE was not different across the 3 groups (P = .37). It declined from 62 ± 6 to 57 ± 7 kcal/kg/d over 5 days post-CPB (P = .02). NB and nitrogen retention became positive by day 3 in the HP group but remained negative in the other 2 groups (P = .045-.003), despite higher urea nitrogen waste in the HP group (P < .0001). The HP group had a greater increase in serum prealbumin level and anthropometric measures (P = .009-.03). Other measures were not significantly different across the 3 groups.
CONCLUSIONS


In infants with complex CHD in the first 5 days post-CPB, protein and energy intakes of ≈4 g/kg/d and 60 kcal/kg/d, respectively, led to improved nutrition outcomes without increased adverse events.",2020,The HP group had a greater increase in serum prealbumin level and anthropometric measures (P = .009-.03).,"['Infants Receiving Early Enteral Nutrition Following Cardiopulmonary Bypass', 'Infants', 'infants with complex CHD following CPB', 'children with congenital heart disease (CHD) after cardiopulmonary bypass (CPB']",[],"['NB and nitrogen retention became positive', 'Resting energy expenditure (REE', 'Adverse outcomes (bacterial infection, reintubation, and cardiac intensive care unit (CICU) stay > 8 days', 'Nitrogen balance (NB); urea nitrogen waste and nitrogen retention; serum prealbumin level; and hepatic, renal, and cardiac function', 'serum prealbumin level and anthropometric measures']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",[],"[{'cui': 'C0429631', 'cui_str': 'Nitrogen balance'}, {'cui': 'C0235432', 'cui_str': 'Nitrogen retention'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0004623', 'cui_str': 'Bacterial infectious disease'}, {'cui': 'C0860359', 'cui_str': 'Reintubate'}, {'cui': 'C0587446', 'cui_str': 'Cardiac intensive care unit'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0600137', 'cui_str': 'Blood urea nitrogen'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C1273508', 'cui_str': 'Serum prealbumin level'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0613378,The HP group had a greater increase in serum prealbumin level and anthropometric measures (P = .009-.03).,"[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Clinical Physiology Laboratory, Capital Institute of Pediatrics, Graduate School of Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yan-Qin', 'Initials': 'YQ', 'LastName': 'Cui', 'Affiliation': ""Cardiac Intensive Care Unit, Heart Center, Guangzhou Women and Children's, Guangzhou Medical University, Guangzhou, Guangdong Province, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': ""Department of Cardiac Surgery, Children's Hospital affiliated to Capital Institute of Pediatrics, Beijing, China.""}, {'ForeName': 'Xin-Xin', 'Initials': 'XX', 'LastName': 'Chen', 'Affiliation': ""Department of Pediatric Surgery, Guangdong Provincial Key Laboratory of Research in Structural Birth Defect Disease, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, Guangdong Province, China.""}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Clinical Physiology Laboratory, Capital Institute of Pediatrics, Graduate School of Peking Union Medical College, Beijing, China.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1863']
1944,32140867,Administration of subcutaneous interferon beta 1a in the evening: data from RELIEF study.,"BACKGROUND


Subcutaneous recombinant interferon-beta 1a (IFN-β1a SC) is indicated for treatment of relapsing multiple sclerosis (RMS); however, it is associated with development of flu-like syndrome (FLS) in 75% of patients. No recommendations are available on whether evening or morning administration could induce better or worse FLS.
OBJECTIVE


Primary objective was to investigate whether morning administration of IFN-β1a 44 µg (Rebif) would affect the severity of FLS versus evening administration, in patients with RMS. Secondary objectives were to investigate whether timing of administration could lead to a better quality of life.
METHODS


Multicenter, open-label, 12-week, randomized, controlled, parallel-group, phase 4 study.
RESULTS


Of 217 patients screened at 29 Italian sites, 200 were included in the study. Among these, 104 patients were randomized to IFN-β1a SC administration in the morning and 96 in the evening. Morning administration resulted in higher FLS scores, as measured by the Multiple Sclerosis Treatment Concern Questionnaire, at week 4 (p = 0.0083) and week 8 (p = 0.0079); however, the difference was no longer significant at the end of 12 weeks.
CONCLUSION


IFN-β1a evening injections in the first 8 weeks of treatment led to an improvement in FLS; when continuing therapy, time of administration could be decided according to patient's lifestyle and preference.",2020,"Morning administration resulted in higher FLS scores, as measured by the Multiple Sclerosis Treatment Concern Questionnaire, at week 4 (p = 0.0083) and week 8 (p = 0.0079); however, the difference was no longer significant at the end of 12 weeks.
","['104 patients', 'patients with RMS', '217 patients screened at 29 Italian sites']","['Subcutaneous recombinant interferon-beta\xa01a (IFN-β1a SC', 'IFN-β1a 44\xa0µg (Rebif', 'subcutaneous interferon', 'IFN-β1a evening injections', 'IFN-β1a SC']","['FLS', 'quality of life', 'higher FLS scores']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0337810', 'cui_str': 'Italians (ethnic group)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0254119', 'cui_str': 'Interferon beta-1a'}, {'cui': 'C0752980', 'cui_str': 'Rebif'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0034380'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.179223,"Morning administration resulted in higher FLS scores, as measured by the Multiple Sclerosis Treatment Concern Questionnaire, at week 4 (p = 0.0083) and week 8 (p = 0.0079); however, the difference was no longer significant at the end of 12 weeks.
","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Patti', 'Affiliation': 'Department G. F. Ingrassia, Neuroscience Section, University of Catania, Via Santa Sofia, 78, 95123, Catania, Italy. patti@unict.it.'}, {'ForeName': 'Giovanni Bosco', 'Initials': 'GB', 'LastName': 'Zimatore', 'Affiliation': 'U.O.C. Neurology, Ospedale Generale Regionale ""F. Miulli"", Acquaviva delle Fonti, BA, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Brescia Morra', 'Affiliation': 'Department of Neuroscience (NSRO), University of Naples Federico II, Napoli, Italy.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Aguglia', 'Affiliation': 'Neurology Department, Hospital ""Bianchi Melacrino Morelli"", Reggio Calabria, Italy.'}, {'ForeName': 'Roberto Bruno', 'Initials': 'RB', 'LastName': 'Bossio', 'Affiliation': 'Multiple Sclerosis Center, Provincial Health Company of Cosenza, Cosenza, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Marziolo', 'Affiliation': 'Neurology Department, Emergency Hospital ""Cannizzaro"", Catania, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Valentino', 'Affiliation': 'Neurology Department, University Hospital ""Località Germaneto"", Catanzaro, Italy.'}, {'ForeName': 'Clara Grazia', 'Initials': 'CG', 'LastName': 'Chisari', 'Affiliation': 'Department G. F. Ingrassia, Neuroscience Section, University of Catania, Via Santa Sofia, 78, 95123, Catania, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Capacchione', 'Affiliation': 'Medical Affairs Department, Merck Serono S.p.A., Rome, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Zappia', 'Affiliation': 'Department G. F. Ingrassia, Neuroscience Section, University of Catania, Via Santa Sofia, 78, 95123, Catania, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of neurology,['10.1007/s00415-020-09771-x']
1945,32141188,Long-term effects of a healthy eating blog in mothers and children.,"In the context of low consumption of vegetables and fruits and milk and alternatives among Canadian mothers and children, novel strategies are needed to improve maternal and child nutrition. This study evaluated the long-term effects of an evidence-informed healthy eating blog on dietary intakes and food-related behaviours of mothers and their child. The study presents a secondary outcome analysis of a randomised controlled trial in which 84 mothers (mean age of 37.6 ± 6.7 years) of 2- to 12-year-old children living in Quebec City, Canada, were randomly assigned to a dietary intervention delivered through a healthy eating blog written by a registered dietitian (RD; n = 42) or a control group (n = 42) during a period of 6 months. Dietary intakes, maternal eating behaviours, food parenting practices, and body weight were measured at baseline, 3 months, at the end of the intervention (6 months), and 6-month post-intervention (12 months). Differences between groups were assessed with mixed linear models. Globally, this study found no evidence of long-term differences in mean dietary intakes in mothers exposed to the blog and their children as well as other food-related outcomes and body weight compared with the control condition. Potential predictors of adherence to dietary recommendations in mothers and children (e.g., involvement of children in household food activities) were identified. In conclusion, a healthy eating blog written by an RD did not result in evidence of any long-term differences in dietary intakes and food-related behaviours in mothers and their children compared with the control condition.",2020,"Globally, this study found no evidence of long-term differences in mean dietary intakes in mothers exposed to the blog and their children as well as other food-related outcomes and body weight compared with the control condition.","['84 mothers (mean age of 37.6 ± 6.7 years) of 2- to 12-year-old children living in Quebec City, Canada', 'Canadian mothers and children', 'mothers and their child', 'mothers and children (e.g., involvement of children in household food activities', 'healthy eating blog in mothers and children']",['dietary intervention delivered through a healthy eating blog written by a registered dietitian (RD; n = 42) or a control group'],"['mean dietary intakes', 'Dietary intakes, maternal eating behaviours, food parenting practices, and body weight', 'dietary intakes and food-related behaviours']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C2718046', 'cui_str': 'Blog'}]","[{'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C2718046', 'cui_str': 'Blog'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general) (occupation)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",84.0,0.0599462,"Globally, this study found no evidence of long-term differences in mean dietary intakes in mothers exposed to the blog and their children as well as other food-related outcomes and body weight compared with the control condition.","[{'ForeName': 'Audrée-Anne', 'Initials': 'AA', 'LastName': 'Dumas', 'Affiliation': 'Centre de recherche Nutrition, Santé et Société (NUTRISS), Institute of Nutrition and Functional Foods, School of Nutrition, Faculty of Agriculture and Food Sciences, Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Lemieux', 'Affiliation': 'Centre de recherche Nutrition, Santé et Société (NUTRISS), Institute of Nutrition and Functional Foods, School of Nutrition, Faculty of Agriculture and Food Sciences, Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Lapointe', 'Affiliation': 'Institute of Nutrition and Functional Foods, Centre de recherche Nutrition, Santé et Société (NUTRISS), Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Provencher', 'Affiliation': 'Centre de recherche Nutrition, Santé et Société (NUTRISS), Institute of Nutrition and Functional Foods, School of Nutrition, Faculty of Agriculture and Food Sciences, Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Robitaille', 'Affiliation': 'Centre de recherche Nutrition, Santé et Société (NUTRISS), Institute of Nutrition and Functional Foods, School of Nutrition, Faculty of Agriculture and Food Sciences, Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Desroches', 'Affiliation': 'Centre de recherche Nutrition, Santé et Société (NUTRISS), Institute of Nutrition and Functional Foods, School of Nutrition, Faculty of Agriculture and Food Sciences, Université Laval, Quebec City, Quebec, Canada.'}]",Maternal & child nutrition,['10.1111/mcn.12981']
1946,31415003,Randomized Comparison of Gastric Tube Reconstruction With and Without Duodenal Diversion Plus Roux-en-Y Anastomosis After Esophagectomy.,"OBJECTIVE


This prospective randomized phase-II trial examined whether gastric reconstruction with duodenal diversion plus Roux-en-Y anastomosis(RY) minimized gastroduodenal reflux and delayed gastric emptying compared with standard gastric reconstruction.
SUMMARY BACKGROUND DATA


There is no established standard surgical procedure to prevent both gastroduodenal reflux and delayed gastric emptying simultaneously.
METHODS


Sixty patients with thoracic esophageal cancer scheduled to undergo esophagectomy with retrosternal gastric tube reconstruction were randomly allocated to standard gastric reconstruction (non-RY, n = 31) or gastric reconstruction with duodenal diversion plus RY (n = 29) groups. Primary endpoint was quality of life assessed by DAUGS-32 score 1 year after surgery. Secondary endpoints were the extent of postoperative duodenal juice reflux into the gastric tube, postoperative morbidity, endoscopic findings, body weight changes, and nutritional status.
RESULTS


Preoperative clinicopathological characteristics and postoperative morbidity did not differ significantly between groups. However, operation time and blood loss volume were significantly higher in the RY group. Pancreatic amylase concentrations in the gastric conduit on postoperative days 2, 3, and 7 were higher in the non-RY group. Postoperative endoscopic examination showed residual gastric content in 7 of 17 patients in the non-RY group but in none in the RY group (P = 0.012). Quality of life was significantly favorable in the RY group with regard to reflux symptoms and food passage dysfunction. Postoperative body weight changes, serum albumin levels, and peripheral blood lymphocyte counts were not significantly different between groups.
CONCLUSION


Gastric reconstruction with duodenal diversion plus RY is effective in improving both gastroduodenal reflux and delayed gastric emptying.",2020,"Pancreatic amylase concentrations in the gastric conduit on postoperative days 2, 3, and 7 were higher in the non-RY group.",['Sixty patients with thoracic esophageal cancer scheduled to undergo esophagectomy with retrosternal gastric tube reconstruction'],"['Gastric Tube Reconstruction With and Without Duodenal Diversion Plus Roux-en-Y Anastomosis', 'standard gastric reconstruction', 'gastric reconstruction with duodenal diversion plus Roux-en-Y anastomosis(RY', 'standard gastric reconstruction (non-RY, n = 31) or gastric reconstruction with duodenal diversion plus RY']","['quality of life assessed by DAUGS-32 score 1 year after surgery', 'Quality of life', 'gastroduodenal reflux and delayed gastric emptying', 'operation time and blood loss volume', 'Preoperative clinicopathological characteristics and postoperative morbidity', 'extent of postoperative duodenal juice reflux into the gastric tube, postoperative morbidity, endoscopic findings, body weight changes, and nutritional status', 'gastroduodenal reflux and delayed gastric emptying simultaneously', 'Postoperative body weight changes, serum albumin levels, and peripheral blood lymphocyte counts', 'reflux symptoms and food passage dysfunction', 'Pancreatic amylase concentrations', 'residual gastric content']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0442179', 'cui_str': 'Retrosternal (qualifier value)'}, {'cui': 'C2242688', 'cui_str': 'Gastric tube reconstruction'}]","[{'cui': 'C2242688', 'cui_str': 'Gastric tube reconstruction'}, {'cui': 'C0013303', 'cui_str': 'Duodenum'}, {'cui': 'C0185033', 'cui_str': 'Diversion'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0002804', 'cui_str': 'Roux-en-Y Anastomosis'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}]","[{'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0450199', 'cui_str': 'Gastroduodenal (qualifier value)'}, {'cui': 'C0740411', 'cui_str': 'Delayed gastric emptying (disorder)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0227306', 'cui_str': 'Duodenal juice (substance)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum (procedure)'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte Number'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0301812', 'cui_str': 'Pancreatic amylase (substance)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0038352', 'cui_str': 'Stomach Contents'}]",60.0,0.0257535,"Pancreatic amylase concentrations in the gastric conduit on postoperative days 2, 3, and 7 were higher in the non-RY group.","[{'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Yano', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Keijiro', 'Initials': 'K', 'LastName': 'Sugimura', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Miyata', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Motoori', 'Affiliation': 'Department of Surgery, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Omori', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Ohue', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Sakon', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan.'}]",Annals of surgery,['10.1097/SLA.0000000000003557']
1947,32495673,Impact of enhanced recovery after surgery on postoperative neutrophil-lymphocyte ratio in patients with colorectal cancer.,"OBJECTIVE


To investigate the impact of enhanced recovery after surgery (ERAS) on the postoperative neutrophil-lymphocyte ratio (NLR) in patients with colorectal cancer.
METHODS


A total of 200 patients with colorectal cancer who underwent surgery between January 2015 and November 2018 were enrolled in the study. They were divided into a traditional treatment group (n=100) and an ERAS group (n=100). The traditional treatment group underwent radical laparoscopic colorectal surgery, and the ERAS group underwent traditional treatment plus the ERAS protocol (preoperative improvement of glucose tolerance, unconventional indwelling stomach and urinary tubes, intraoperative body temperature management, fluid management, postoperative pain management, early oral feeding, and early activities). Clinical data were collected for all patients. NLR levels before and after surgery, and complications were compared between the two groups.
RESULTS


Postoperative NLR was significantly lower in the ERAS compared with the traditional treatment group. The incidence of complications, including anastomotic leakage, pulmonary infection, urinary tract infection, and cardiopulmonary dysfunction were also significantly lower in the ERAS group.
CONCLUSION


Enhanced recovery after surgery can reduce the increase in postoperative NLR and reduce the occurrence of postoperative complications, which results will be of clinical value.",2020,"The incidence of complications, including anastomotic leakage, pulmonary infection, urinary tract infection, and cardiopulmonary dysfunction were also significantly lower in the ERAS group.
","['patients with colorectal cancer', '200 patients with colorectal cancer who underwent surgery between January 2015 and November 2018 were enrolled in the study']","['surgery (ERAS', 'radical laparoscopic colorectal surgery, and the ERAS group underwent traditional treatment plus the ERAS protocol (preoperative improvement of glucose tolerance, unconventional indwelling stomach and urinary tubes, intraoperative body temperature management, fluid management, postoperative pain management, early oral feeding, and early activities', 'ERAS']","['NLR levels', 'postoperative neutrophil-lymphocyte ratio', 'Postoperative NLR', 'postoperative neutrophil-lymphocyte ratio (NLR', 'incidence of complications, including anastomotic leakage, pulmonary infection, urinary tract infection, and cardiopulmonary dysfunction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0439848', 'cui_str': 'Indwelling'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0553741', 'cui_str': 'Fluid balance regulation'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0876973', 'cui_str': 'Infectious disease of lung'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]",200.0,0.0155312,"The incidence of complications, including anastomotic leakage, pulmonary infection, urinary tract infection, and cardiopulmonary dysfunction were also significantly lower in the ERAS group.
","[{'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Yuwei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Cancer Radiotherapy Center of Chongqing Cancer Hospital, Chongqing, China.'}, {'ForeName': 'Zhongxue', 'Initials': 'Z', 'LastName': 'Fu', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}]",The Journal of international medical research,['10.1177/0300060520925941']
1948,32140752,"A revalidation and critique of assumptions about urinary sample collection methods, specimen quality and contamination.","INTRODUCTION AND HYPOTHESIS


Midstream urine (MSU) is key in assessing lower urinary tract syndrome (LUTS), but contingent on some assumptions. The aim of this study was to compare the occurrence of contamination and the quality of substrates obtained from four different collections: MSU, catheter specimen urine (CSU), a commercial MSU collecting device (Peezy) and a natural void. Contamination was quantified by differential, uroplakin-positive, urothelial cell counts.
METHODS


This was a single blind, crossover study conducted in two phases. First, we compared the MSU with CSU using urine culture, pyuria counts and differential counting of epithelial cells after immunofluorescence staining for uroplakin III (UP3). Second, we compared the three non-invasive (MSU, Peezy MSU™, natural void) methods using UP3 antibody staining only.
RESULTS


The natural void was best at collecting bladder urinary sediment, with the majority of epithelial cells present derived from the urinary tract. CSU sampling missed much of the urinary sediment and showed sparse culture results. Finally, the MSU collection methods did not capture much of the bladder sediment.
CONCLUSION


We found little evidence for contamination with the four methods. Natural void was the best method for harvesting shed urothelial cells and white blood cells. It provides a richer sample of the inflammatory exudate, including parasitised urothelial cells and the microbial substrate. However, if the midstream sample is believed to be important, the MSU collection device is advantageous.",2020,We found little evidence for contamination with the four methods.,[],['catheter specimen urine (CSU'],[],[],"[{'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0042037'}]",[],,0.0563349,We found little evidence for contamination with the four methods.,"[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Collins', 'Affiliation': 'School of Nursing, Kingston University, Frank Lampl Building, Kingston Hill Campus, London, UK. l.collins@sgul.kingston.ac.uk.'}, {'ForeName': 'Sanchutha', 'Initials': 'S', 'LastName': 'Sathiananthamoorthy', 'Affiliation': 'Department of Renal Medicine, Division of Medicine, University College London, London, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rohn', 'Affiliation': 'Department of Renal Medicine, Division of Medicine, University College London, London, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Malone-Lee', 'Affiliation': 'Department of Renal Medicine, Division of Medicine, University College London, London, UK.'}]",International urogynecology journal,['10.1007/s00192-020-04272-x']
1949,31409366,Supraglottic jet oxygenation and ventilation for obese patients under intravenous anesthesia during hysteroscopy: a randomized controlled clinical trial.,"BACKGROUND


Supraglottic jet oxygenation and ventilation (SJOV) can effectively maintain adequate oxygenation in patients with respiratory depression, even in apnea patients. However, there have been no randomized controlled clinical trials of SJOV in obese patients. This study investigated the efficacy and safety of SJOV using WEI Nasal Jet tube (WNJ) for obese patients who underwent hysteroscopy under intravenous anesthesia without endotracheal intubation.
METHODS


A single-center, prospective, randomized controlled study was conducted. The obese patients receiving hysteroscopy under intravenous anesthesia were randomly divided into three groups: Control group maintaining oxygen supply via face masks (100% oxygen, flow at 6 L/min), the WNJ Oxygen Group with WNJ (100% oxygen, flow: 6 L/min) and the WNJ SJOV Group with SJOV via WNJ [Jet ventilator working parameters:100% oxygen supply, driving pressure (DP) 0.1 MPa, respiratory rate; (RR): 15 bpm, I/E; ratio 1:1.5]. SpO 2 , P ET CO 2 , BP, HR, ECG and BIS were continuously monitored during anesthesia. Two-Diameter Method was deployed to measure cross sectional area of the gastric antrum (CSA-GA) by ultrasound before and after SJOV in the WNJ SJOV Group. Episodes of SpO 2  less than 95%, P ET CO 2  less than 10 mmHg, depth of WNJ placement and measured CSA-GA before and after jet ventilation in the WNJ SJOV Group during the operation were recorded. The other adverse events were collected as well.
RESULTS


A total of 102 patients were enrolled, with two patients excluded. Demographic characteristics were similar among the three groups. Compared with the Control Group, the incidence of P ET CO 2  < 10 mmHg, SpO 2  < 95% in the WNJ SJOV group dropped from 36 to 9% (P = 0.009),from 33 to 6% (P = 0.006) respectively,and the application rate of jaw-lift decreased from 33 to 3% (P = 0.001), and the total percentage of adverse events decreased from 36 to 12% (P = 0.004). Compared with the WNJ Oxygen Group, the use of SJOV via WNJ significantly decreased episodes of SpO 2  < 95% from 27 to 6% (P = 0.023), P ET CO 2  < 10 mmHg from 33 to 9% (P = 0.017), respectively. Depth of WNJ placement was about 12.34 cm in WNJ SJOV Group. There was no significantly difference of CSA-GA before and after SJOV in the WNJ SJOV Group (P = 0.234). There were no obvious cases of nasal bleeding in all the three groups.
CONCLUSIONS


SJOV can effectively and safely maintain adequate oxygenation in obese patients under intravenous anesthesia without intubation during hysteroscopy. This efficient oxygenation may be mainly attributed to supplies of high concentration oxygenation to the supraglottic area, and the high pressure jet pulse providing effective ventilation. Although the nasal airway tube supporting collapsed airway by WNJ also plays a role. SJOV doesn't seem to increase gastric distension and the risk of aspiration. SJOV can improve the safety of surgery by reducing the incidence of the intraoperative involuntary limbs swing, hip twist and cough.
TRIAL REGISTRATION


Chinese Clinical Trial Registry. Registration number, ChiCTR1800017028, registered on July 9, 2018.",2019,There was no significantly difference of CSA-GA before and after SJOV in the WNJ SJOV Group (P = 0.234).,"['obese patients who underwent hysteroscopy under intravenous anesthesia without endotracheal intubation', 'obese patients receiving hysteroscopy under intravenous anesthesia', '102 patients were enrolled, with two patients excluded', 'obese patients', 'obese patients under intravenous anesthesia during hysteroscopy', 'obese patients under intravenous anesthesia without intubation during hysteroscopy', 'patients with respiratory depression, even in apnea patients']","['SJOV using WEI Nasal Jet tube (WNJ', 'SJOV', 'Control group maintaining oxygen supply via face masks (100% oxygen, flow at 6\u2009L/min), the WNJ Oxygen Group with WNJ (100% oxygen, flow: 6\u2009L/min) and the WNJ SJOV Group with SJOV via WNJ [Jet ventilator working parameters:100% oxygen supply, driving pressure', 'Supraglottic jet oxygenation and ventilation', 'SJOV via WNJ', 'Supraglottic jet oxygenation and ventilation (SJOV']","['Demographic characteristics', 'depth of WNJ placement and measured CSA-GA', 'CSA-GA', 'nasal bleeding', 'total percentage of adverse events', 'episodes of SpO', 'gastric distension', 'incidence of P ET CO', 'application rate of jaw-lift', 'SpO 2 , P ET CO 2 , BP, HR, ECG and BIS']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020710', 'cui_str': 'Uterine Endoscopy'}, {'cui': 'C0002920', 'cui_str': 'Anesthesia, Intravenous'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0235063', 'cui_str': 'Respiratory Depression'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}]","[{'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C0180823', 'cui_str': 'Face mask (physical object)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439393', 'cui_str': 'liter/minute'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0442192', 'cui_str': 'Supraglottic (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0014591', 'cui_str': 'Nosebleed'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C3714614', 'cui_str': 'Distention'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0181620', 'cui_str': 'Lift'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C1872096', 'cui_str': 'bis(phenylacetylarginine)'}]",102.0,0.0521506,There was no significantly difference of CSA-GA before and after SJOV in the WNJ SJOV Group (P = 0.234).,"[{'ForeName': 'Hansheng', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': ""Department of Anesthesiology, Peking University People's Hospital, Beijing100044, Beijing, China.""}, {'ForeName': 'Yuantao', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': ""Department of Anesthesiology, Peking University People's Hospital, Beijing100044, Beijing, China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': ""Department of Anesthesiology, Peking University People's Hospital, Beijing100044, Beijing, China.""}, {'ForeName': 'Qingyue', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, Peking University People's Hospital, Beijing100044, Beijing, China.""}, {'ForeName': 'Huafeng', 'Initials': 'H', 'LastName': 'Wei', 'Affiliation': 'Department of Anesthesiology and Critical Care, Hospital of the University of Pennsylvania, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': ""Department of Anesthesiology, Peking University People's Hospital, Beijing100044, Beijing, China. fengyimzk@163.com.""}]",BMC anesthesiology,['10.1186/s12871-019-0821-8']
1950,32111199,Sick-listed workers' experiences with motivational interviewing in the return to work process: a qualitative interview study.,"BACKGROUND


When returning to work after being on long-term sick leave, individuals may experience varying levels of motivation and self-efficacy. Motivational interviewing (MI) is a counseling style that aims to increase motivation towards change, and it may be useful in the return to work (RTW) process. The aim of this study was to explore sick-listed workers' experiences with MI in the RTW process.
METHODS


This qualitative study was part of a randomized controlled trial evaluating the effects of MI on the RTW process, and it was administered by caseworkers at the Norwegian Labor and Welfare Administration. Sixteen sick-listed individuals, aged 33-60, participated in semi-structured interviews. All had a sick leave status of 50-100% for at least 8 weeks when interviewed and all had completed 2 MI sessions. The data was analyzed with systematic text condensation.
RESULTS


Participants' experiences of the MI sessions were categorized into three themes: (1) relationship with the MI caseworker, (2) normalizing sick leave, and (3) adjusting RTW strategies. The MI sessions were experienced as a positive encounter due to the supportive relationship that was built between the MI caseworker and the sick-listed worker. Being sick listed led to feelings of guilt and stigmatization, but acceptance and support from the MI caseworkers helped normalize the situation for the sick-listed workers. Furthermore, MI sessions allowed for personalized feedback and discussions on adjustments to their RTW strategies.
CONCLUSION


Sick-listed workers experienced MI as positive due to the good relationship that developed with the MI caseworker, how this normalized sick leave, and the help they received with adjusting their RTW strategies. Professionals working with individuals attempting to RTW may benefit from using MI as a method for helping sick-listed workers to RTW.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03212118 (registered July 11, 2017).",2020,"Being sick listed led to feelings of guilt and stigmatization, but acceptance and support from the MI caseworkers helped normalize the situation for the sick-listed workers.","['Sixteen sick-listed individuals, aged 33-60, participated in semi-structured interviews', ""sick-listed workers' experiences with MI in the RTW process""]","['motivational interviewing', 'Motivational interviewing (MI']",[],"[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}]",[],,0.0560883,"Being sick listed led to feelings of guilt and stigmatization, but acceptance and support from the MI caseworkers helped normalize the situation for the sick-listed workers.","[{'ForeName': 'Vegard Stolsmo', 'Initials': 'VS', 'LastName': 'Foldal', 'Affiliation': 'Department of Public Health and Nursing, Faculty of Medicine and Health Science, Norwegian University of Science and Technology, Postboks 8905, MTFS, 7491, Trondheim, Norway. vegard.foldal@ntnu.no.'}, {'ForeName': 'Martin Inge', 'Initials': 'MI', 'LastName': 'Standal', 'Affiliation': 'Department of Psychology, Faculty of Social and Educational Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Aasdahl', 'Affiliation': 'Department of Public Health and Nursing, Faculty of Medicine and Health Science, Norwegian University of Science and Technology, Postboks 8905, MTFS, 7491, Trondheim, Norway.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Hagen', 'Affiliation': 'Department of Psychology, Faculty of Social and Educational Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Gunnhild', 'Initials': 'G', 'LastName': 'Bagøien', 'Affiliation': 'Tiller Community Mental Health Centre, Division of Psychiatry, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Egil Andreas', 'Initials': 'EA', 'LastName': 'Fors', 'Affiliation': 'Department of Public Health and Nursing, Faculty of Medicine and Health Science, Norwegian University of Science and Technology, Postboks 8905, MTFS, 7491, Trondheim, Norway.'}, {'ForeName': 'Roar', 'Initials': 'R', 'LastName': 'Johnsen', 'Affiliation': 'Department of Public Health and Nursing, Faculty of Medicine and Health Science, Norwegian University of Science and Technology, Postboks 8905, MTFS, 7491, Trondheim, Norway.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Solbjør', 'Affiliation': 'Department of Public Health and Nursing, Faculty of Medicine and Health Science, Norwegian University of Science and Technology, Postboks 8905, MTFS, 7491, Trondheim, Norway.'}]",BMC public health,['10.1186/s12889-020-8382-9']
1951,32135068,Airway Oscillometry Detects Spirometric-Silent Episodes of Acute Cellular Rejection.,"Rationale:  Acute cellular rejection (ACR) is common during the initial 3 months after lung transplant. Patients are monitored with spirometry and routine surveillance transbronchial biopsies. However, many centers monitor patients with spirometry only because of the risks and insensitivity of transbronchial biopsy for detecting ACR. Airway oscillometry is a lung function test that detects peripheral airway inhomogeneity with greater sensitivity than spirometry. Little is known about the role of oscillometry in patient monitoring after a transplant. Objectives:  To characterize oscillometry measurements in biopsy-proven clinically significant (grade ≥2 ACR) in the first 3 months after a transplant. Methods:  We enrolled 156 of the 209 double lung transplant recipients between December 2017 and March 2019. Weekly outpatient oscillometry and spirometry and surveillance biopsies at Weeks 6 and 12 were conducted at our center. Measurements and Main Results:  Of the 138 patients followed for 3 or more months, 15 patients had 16 episodes of grade 2 ACR (AR2) and 44 patients had 64 episodes of grade 0 ACR (AR0) rejection associated with stable and/or improving spirometry. In 15/16 episodes of AR2, spirometry was stable or improving in the weeks leading to transbronchial biopsy. However, oscillometry was markedly abnormal and significantly different from AR0 ( P  < 0.05), particularly in integrated area of reactance and the resistance between 5 and 19 Hz, the indices of peripheral airway obstruction. By 2 weeks after biopsy, after treatment for AR2, oscillometry in the AR2 group improved and was similar to the AR0 group. Conclusions:  Oscillometry identified physiological changes associated with AR2 that were not discernible by spirometry and is useful for graft monitoring after a lung transplant.",2020,Airway oscillometry (OSc) is a lung function test that detects peripheral airway inhomogeneity with greater sensitivity than spirometry.,['We enrolled 156 of the 209 double lung transplant recipients between December 2017 and March 2019'],[],"['grade 0 rejection associated with stable/improving spirometry (AR0', 'peripheral airway obstruction']","[{'cui': 'C0396599', 'cui_str': 'Double lung transplant (procedure)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",[],"[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0001883', 'cui_str': 'Airway Obstruction'}]",156.0,0.0248294,Airway oscillometry (OSc) is a lung function test that detects peripheral airway inhomogeneity with greater sensitivity than spirometry.,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cho', 'Affiliation': 'Division of Respirology, Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Joyce K Y', 'Initials': 'JKY', 'LastName': 'Wu', 'Affiliation': 'Division of Respirology, Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Daniella Cunha', 'Initials': 'DC', 'LastName': 'Birriel', 'Affiliation': 'Division of Respirology, Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Matelski', 'Affiliation': 'Biostatistics Research Unit, and.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Nadj', 'Affiliation': 'Division of Respirology, Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'DeHaas', 'Affiliation': 'Division of Respirology, Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Division of Respirology, Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Yang', 'Affiliation': 'Division of Respirology, Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Division of Respirology, Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Aloysius B', 'Initials': 'AB', 'LastName': 'Cheung', 'Affiliation': 'Division of Respirology, Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Lindsay N', 'Initials': 'LN', 'LastName': 'Woo', 'Affiliation': 'Division of Respirology, Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Day', 'Affiliation': 'Division of Respirology, Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Cypel', 'Affiliation': 'Toronto Lung Transplant Programme, Multi-Organ Transplant Unit.'}, {'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Tikkanen', 'Affiliation': 'Division of Respirology, Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Clodagh', 'Initials': 'C', 'LastName': 'Ryan', 'Affiliation': 'Division of Respirology, Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Chung-Wai', 'Initials': 'CW', 'LastName': 'Chow', 'Affiliation': 'Division of Respirology, Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201908-1539OC']
1952,31804894,Phase III Trial of Adjuvant Capecitabine After Standard Neo-/Adjuvant Chemotherapy in Patients With Early Triple-Negative Breast Cancer (GEICAM/2003-11_CIBOMA/2004-01).,"PURPOSE


Operable triple-negative breast cancers (TNBCs) have a higher risk of relapse than non-TNBCs with standard therapy. The GEICAM/2003-11_CIBOMA/2004-01 trial explored extended adjuvant capecitabine after completion of standard chemotherapy in patients with early TNBC.
PATIENTS AND METHODS


Eligible patients were those with operable, node-positive-or node negative with tumor 1 cm or greater-TNBC, with prior anthracycline- and/or taxane-containing chemotherapy. After central confirmation of TNBC status by immunohistochemistry, patients were randomly assigned to either capecitabine or observation. Stratification factors included institution, prior taxane-based therapy, involved axillary lymph nodes, and centrally determined phenotype (basal  v  nonbasal, according to cytokeratins 5/6 and/or epidermal growth factor receptor positivity by immunohistochemistry). The primary objective was to compare disease-free survival (DFS) between both arms.
RESULTS


Eight hundred seventy-six patients were randomly assigned to capecitabine (n = 448) or observation (n = 428). Median age was 49 years, 55.9% were lymph node negative, 73.9% had a basal phenotype, and 67.5% received previous anthracyclines plus taxanes. Median length of follow-up was 7.3 years. DFS was not significantly prolonged with capecitabine versus observation [hazard ratio (HR), 0.82; 95% CI, 0.63 to 1.06;  P  = .136]. In a preplanned subgroup analysis, nonbasal patients seemed to derive benefit from the addition of capecitabine with a DFS HR of 0.53 versus 0.94 in those with basal phenotype (interaction test  P  = .0694) and an HR for overall survival of 0.42 versus 1.23 in basal phenotype (interaction test  P  = .0052). Tolerance of capecitabine was as expected, with 75.2% of patients completing the planned 8 cycles.
CONCLUSION


This study failed to show a statistically significant increase in DFS by adding extended capecitabine to standard chemotherapy in patients with early TNBC. In a preplanned subset analysis, patients with nonbasal phenotype seemed to obtain benefit with capecitabine, although this will require additional validation.",2020,"DFS was not significantly prolonged with capecitabine versus observation [hazard ratio (HR), 0.82; 95% CI, 0.63 to 1.06;  P  = .136].","['Patients With Early Triple-Negative Breast Cancer', 'Eligible patients were those with operable, node-positive-or node negative with tumor 1 cm or greater-TNBC, with prior', 'Median age was 49 years, 55.9% were lymph node negative, 73.9% had a basal phenotype, and 67.5% received previous', 'Eight hundred seventy-six patients', 'patients with early TNBC']","['Adjuvant Capecitabine', 'anthracycline- and/or taxane-containing chemotherapy', 'anthracyclines plus taxanes', 'capecitabine or observation', 'capecitabine', 'Standard Neo-/Adjuvant Chemotherapy']","['Median length', 'DFS', 'disease-free survival (DFS', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C3539878', 'cui_str': 'Triple Negative Breast Cancer'}, {'cui': 'C0205188', 'cui_str': 'Operable (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0647859', 'cui_str': 'AM49'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C4319622', 'cui_str': 'Seventy-six'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",876.0,0.122436,"DFS was not significantly prolonged with capecitabine versus observation [hazard ratio (HR), 0.82; 95% CI, 0.63 to 1.06;  P  = .136].","[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Lluch', 'Affiliation': 'Hospital Clínico Universitario de Valencia and Biomedical Research Institute INCLIVA, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Carlos H', 'Initials': 'CH', 'LastName': 'Barrios', 'Affiliation': 'Centro de Pesquisa Clínica Hospital São Lucas da PUCRS, Porto Alegre, Brazil.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Torrecillas', 'Affiliation': 'Centro Médico Nacional 20 de Noviembre, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado, Ciudad de México, México.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ruiz-Borrego', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Bines', 'Affiliation': 'LACOG, Latin American Cooperative Oncology Group, Porto Alegre, Brazil.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Segalla', 'Affiliation': 'LACOG, Latin American Cooperative Oncology Group, Porto Alegre, Brazil.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Guerrero-Zotano', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'García-Sáenz', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Torres', 'Affiliation': 'Instituto Nacional del Cáncer, Santiago, Chile.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'de la Haba', 'Affiliation': 'Centro de Investigación Biomédica en Red de Oncología ISCIII, Madrid, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'García-Martínez', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Henry L', 'Initials': 'HL', 'LastName': 'Gómez', 'Affiliation': 'Instituto Nacional de Enfermedades Neoplásicas, Lima, Perú.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Llombart', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Javier Salvador', 'Initials': 'JS', 'LastName': 'Bofill', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Baena-Cañada', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Agustí', 'Initials': 'A', 'LastName': 'Barnadas', 'Affiliation': 'Centro de Investigación Biomédica en Red de Oncología ISCIII, Madrid, Spain.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Calvo', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pérez-Michel', 'Affiliation': 'Hospital de San José, Ciudad Obregón, Sonora, México.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ramos', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Isaura', 'Initials': 'I', 'LastName': 'Fernández', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Rodríguez-Lescure', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Cárdenas', 'Affiliation': 'Centro Médico Colima, Colima, México.'}, {'ForeName': 'Jeferson', 'Initials': 'J', 'LastName': 'Vinholes', 'Affiliation': 'LACOG, Latin American Cooperative Oncology Group, Porto Alegre, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Martínez de Dueñas', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Godes', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Seguí', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Antón', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'López-Álvarez', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Moncayo', 'Affiliation': 'Social S Hospital Teodoro Maldonado Carbo, Guayaquil, Ecuador.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'Amorim', 'Affiliation': 'LACOG, Latin American Cooperative Oncology Group, Porto Alegre, Brazil.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Villar', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Reyes', 'Affiliation': 'Hospital Beneficiencia Española, San Luis de Potosí, México.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Sampaio', 'Affiliation': 'LACOG, Latin American Cooperative Oncology Group, Porto Alegre, Brazil.'}, {'ForeName': 'Bernardita', 'Initials': 'B', 'LastName': 'Cardemil', 'Affiliation': 'Hospital Base de Valdivia, Valdivia, Chile.'}, {'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Escudero', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Bezares', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Carrasco', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Martín', 'Affiliation': 'Centro de Investigación Biomédica en Red de Oncología ISCIII, Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00904']
1953,31573913,A Web-Based Photo-Alteration Intervention to Promote Sleep: Randomized Controlled Trial.,"BACKGROUND


Receiving insufficient sleep has wide-ranging consequences for health and well-being. Although educational programs have been developed to promote sleep, these have had limited success in extending sleep duration. To address this gap, we developed a Web-based program emphasizing how physical appearances change with varying amounts of sleep.
OBJECTIVE


The aims of this study were to evaluate (1) whether participants can detect changes in appearances as a function of sleep and (2) whether this intervention can alter habitual sleep patterns.
METHODS


We conducted a 5-week, parallel-group, randomized controlled trial among 70 habitual short sleepers (healthy adults who reported having <7 hours of sleep routinely). Upon study enrollment, participants were randomly assigned (1:1) to receive either standard information or an appearance-based intervention. Both groups received educational materials about sleep, but those in the appearance group also viewed a website containing digitally edited photographs that showed how they would look with varying amounts of sleep. As the outcome variables, sleep duration was monitored objectively via actigraphy (at baseline and at postintervention weeks 1 and 4), and participants completed a measure of sleep hygiene (at baseline and at postintervention weeks 2, 4, and 5). For each outcome, we ran intention-to-treat analyses using linear mixed-effects models.
RESULTS


In total, 35 participants were assigned to each group. Validating the intervention, participants in the appearance group (1) were able to identify what they looked like at baseline and (2) judged that they would look more attractive with a longer sleep duration (t 26 =10.35, P<.001). In turn, this translated to changes in sleep hygiene. Whereas participants in the appearance group showed improvements following the intervention (F 1,107.99 =9.05, P=.003), those in the information group did not (F 1,84.7 =0.19, P=.66). Finally, there was no significant effect of group nor interaction of group and time on actigraphy-measured sleep duration (smallest P=.26).
CONCLUSIONS


Our findings suggest that an appearance-based intervention, while not sufficient as a stand-alone, could have an adjunctive role in sleep promotion.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02491138; https://clinicaltrials.gov/ct2/show/study/NCT02491138.",2019,"Whereas participants in the appearance group showed improvements following the intervention (F 1,107.99 =9.05, P=.003), those in the information group did not (F 1,84.7 =0.19, P=.66).","['70 habitual short sleepers (healthy adults who reported having <7 hours of sleep routinely', 'Promote Sleep']","['educational materials about sleep', 'A Web-Based Photo-Alteration Intervention', 'standard information or an appearance-based intervention']","['actigraphy-measured sleep duration', 'sleep hygiene', 'habitual sleep patterns', 'sleep duration']","[{'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0751509', 'cui_str': 'Short Sleeper Syndrome'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}]","[{'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4277672', 'cui_str': 'Sleep Hygiene'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0474396', 'cui_str': 'Sleep pattern finding'}]",35.0,0.141443,"Whereas participants in the appearance group showed improvements following the intervention (F 1,107.99 =9.05, P=.003), those in the information group did not (F 1,84.7 =0.19, P=.66).","[{'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Perucho', 'Affiliation': 'Division of Social Sciences, Yale-NUS College, Singapore, Singapore.'}, {'ForeName': 'Kamalakannan M', 'Initials': 'KM', 'LastName': 'Vijayakumar', 'Affiliation': 'Division of Social Sciences, Yale-NUS College, Singapore, Singapore.'}, {'ForeName': 'Sean N', 'Initials': 'SN', 'LastName': 'Talamas', 'Affiliation': 'School of Psychology, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Michael Wei-Liang', 'Initials': 'MW', 'LastName': 'Chee', 'Affiliation': 'Neuroscience and Behavioral Disorders Programme, Duke-NUS Medical School, Singapore, Singapore.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Perrett', 'Affiliation': 'School of Psychology and Neuroscience, University of St Andrews, St Andrews, United Kingdom.'}, {'ForeName': 'Jean C J', 'Initials': 'JCJ', 'LastName': 'Liu', 'Affiliation': 'Division of Social Sciences, Yale-NUS College, Singapore, Singapore.'}]",Journal of medical Internet research,['10.2196/12500']
1954,32182235,Methods detecting rhythmic gene expression are biologically relevant only for strong signal.,"The nycthemeral transcriptome embodies all genes displaying a rhythmic variation of their mRNAs periodically every 24 hours, including but not restricted to circadian genes. In this study, we show that the nycthemeral rhythmicity at the gene expression level is biologically functional and that this functionality is more conserved between orthologous genes than between random genes. We used this conservation of the rhythmic expression to assess the ability of seven methods (ARSER, Lomb Scargle, RAIN, JTK, empirical-JTK, GeneCycle, and meta2d) to detect rhythmic signal in gene expression. We have contrasted them to a naive method, not based on rhythmic parameters. By taking into account the tissue-specificity of rhythmic gene expression and different species comparisons, we show that no method is strongly favored. The results show that these methods designed for rhythm detection, in addition to having quite similar performances, are consistent only among genes with a strong rhythm signal. Rhythmic genes defined with a standard p-value threshold of 0.01 for instance, could include genes whose rhythmicity is biologically irrelevant. Although these results were dependent on the datasets used and the evolutionary distance between the species compared, we call for caution about the results of studies reporting or using large sets of rhythmic genes. Furthermore, given the analysis of the behaviors of the methods on real and randomized data, we recommend using primarily ARS, empJTK, or GeneCycle, which verify expectations of a classical distribution of p-values. Experimental design should also take into account the circumstances under which the methods seem more efficient, such as giving priority to biological replicates over the number of time-points, or to the number of time-points over the quality of the technique (microarray vs RNAseq). GeneCycle, and to a lesser extent empirical-JTK, might be the most robust method when applied to weakly informative datasets. Finally, our analyzes suggest that rhythmic genes are mainly highly expressed genes.",2020,"The results show that these methods designed for rhythm detection, in addition to having quite similar performances, are consistent only among genes with a strong rhythm signal.",[],[],[],[],[],[],,0.0279694,"The results show that these methods designed for rhythm detection, in addition to having quite similar performances, are consistent only among genes with a strong rhythm signal.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Laloum', 'Affiliation': 'Department of Ecology and Evolution, Batiment Biophore, Quartier UNIL-Sorge, Université de Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Robinson-Rechavi', 'Affiliation': 'Department of Ecology and Evolution, Batiment Biophore, Quartier UNIL-Sorge, Université de Lausanne, Lausanne, Switzerland.'}]",PLoS computational biology,['10.1371/journal.pcbi.1007666']
1955,32493447,Effect of hydroxychloroquine on prevention of COVID-19 virus infection among healthcare professionals: a structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


Comparison of the effect of hydroxychloroquine with placebo to prevent infection from the COVID -19 virus among healthcare professionals TRIAL DESIGN: Single centre, 2-arm, double-blind randomised (ratio 1:1) placebo-controlled trial PARTICIPANTS: Treatment staff who are in contact with patients and have at least 3 shifts a week in Arash hospital affiliated with Tehran University of Medical Sciences, in Iran and who consent to participate in the study. Exclusion criteria include: History of COVID -19 virus infection, clinical symptoms such as fever, nausea, dyspnea and myalgia in the past two months, history of underlying diseases hypersensitivity to hydroxychloroquine and G6PD enzyme deficiency.
INTERVENTION AND COMPARATOR


Intervention group: Hydroxychloroquine 200 mg tablet of Amin Pharmaceutical.
CONTROL GROUP


placebo which is completely similar in form and taste to 200 mg hydroxychloroquine tablet and is manufactured by the same factory (Amin Pharmacy). The dosage is two tablets daily, once a week for one to three months (based on the duration of the Coronavirus epidemic in Tehran).
MAIN OUTCOMES


Confirmed COVID-19 virus infection using Polymerase chain reaction (PCR) test is the primary outcome. The time period for measuring the primary outcome is any infection within the trial period up to one month after taking the last dose.
RANDOMISATION


The randomized block allocation method was developed using Stata version 15 software by an independent researcher, using a block size of six. Allocation to the two treatment groups will be conducted by this researcher using paper labels (random 10-digit codes) in a 1:1 ratio t The labels will be attached to the drug packages in order of randomization. Drug packages will be arranged in a box according to the randomization list.
BLINDING (MASKING)


Participants and caregivers are blinded to group assignment and the data will be analyzed by an independent statistical expert who is unaware of the treatment allocation.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


A total of 282 participants will be randomised with 141 participants the Hydroxychloroquineeach intervention group and 141 participants to the placebo control group TRIAL STATUS: The protocol version number is 99-1-101-47091 and the approval ID is IR.TUMS.VCR.REC.1399.001 and recruitment began April 7, 2020, and is anticipated to be complete by August 7, 2020.
TRIAL REGISTRATION


The name of the trial register is Iranian registry of clinical trial (IRCT), registration number is IRCT20120826010664N6, date of trial registration is April 7, 2020, FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"Single centre, 2-arm, double-blind randomised (ratio 1:1)","['282 participants will be randomised with 141 participants the Hydroxychloroquineeach intervention group and 141 participants to the', 'healthcare professionals', ' Treatment staff who are in contact with patients and have at least 3 shifts a week in Arash hospital affiliated with Tehran University of Medical Sciences, in Iran and who consent to participate in the study']","['GROUP\n\n\nplacebo', 'hydroxychloroquine', 'hydroxychloroquine with placebo', 'placebo control', 'Hydroxychloroquine 200 mg tablet of Amin Pharmaceutical', 'placebo']",['COVID-19 virus infection using Polymerase chain reaction (PCR) test'],"[{'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",282.0,0.426417,"Single centre, 2-arm, double-blind randomised (ratio 1:1)","[{'ForeName': 'Reihaneh', 'Initials': 'R', 'LastName': 'Pirjani', 'Affiliation': ""Department of Obstetrics and Gynecology, Arash Women's Hospital, Tehran University of Medical Sciences, Tehran, Iran. pirjani@razi.tums.ac.ir.""}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Soori', 'Affiliation': 'Department of Infectious Diseases, Arash Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ahmad Reza', 'Initials': 'AR', 'LastName': 'Dehpour', 'Affiliation': 'Department of Pharmacology, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Sepidarkish', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Public Health, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Moini', 'Affiliation': ""Department of Obstetrics and Gynecology, Arash Women's Hospital, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Arshia', 'Initials': 'A', 'LastName': 'Shizarpour', 'Affiliation': 'School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Razieh', 'Initials': 'R', 'LastName': 'Mohammad Jafari', 'Affiliation': 'Experimental Medicine Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}]",Trials,['10.1186/s13063-020-04439-3']
1956,32235144,Multimodal Analgesic Regimen for Spine Surgery: A Randomized Placebo-controlled Trial.,"BACKGROUND


Various multimodal analgesic approaches have been proposed for spine surgery. The authors evaluated the effect of using a combination of four nonopioid analgesics versus placebo on Quality of Recovery, postoperative opioid consumption, and pain scores.
METHODS


Adults having multilevel spine surgery who were at high risk for postoperative pain were double-blind randomized to placebos or the combination of single preoperative oral doses of acetaminophen 1,000 mg and gabapentin 600 mg, an infusion of ketamine 5 µg/kg/min throughout surgery, and an infusion of lidocaine 1.5 mg/kg/h intraoperatively and during the initial hour of recovery. Postoperative analgesia included acetaminophen, gabapentin, and opioids. The primary outcome was the Quality of Recovery 15-questionnaire (0 to 150 points, with 15% considered to be a clinically important difference) assessed on the third postoperative day. Secondary outcomes were opioid use in morphine equivalents (with 20% considered to be a clinically important change) and verbal-response pain scores (0 to 10, with a 1-point change considered important) over the initial postoperative 48 h.
RESULTS


The trial was stopped early for futility per a priori guidelines. The average duration ± SD of surgery was 5.4 ± 2.1 h. The mean ± SD Quality of Recovery score was 109 ± 25 in the pathway patients (n = 150) versus 109 ± 23 in the placebo group (n = 149); estimated difference in means was 0 (95% CI, -6 to 6, P = 0.920). Pain management within the initial 48 postoperative hours was not superior in analgesic pathway group: 48-h opioid consumption median (Q1, Q3) was 72 (48, 113) mg in the analgesic pathway group and 75 (50, 152) mg in the placebo group, with the difference in medians being -9 (97.5% CI, -23 to 5, P = 0.175) mg. Mean 48-h pain scores were 4.8 ± 1.8 in the analgesic pathway group versus 5.2 ± 1.9 in the placebo group, with the difference in means being -0.4 (97.5% CI; -0.8, 0.1, P = 0.094).
CONCLUSIONS


An analgesic pathway based on preoperative acetaminophen and gabapentin, combined with intraoperative infusions of lidocaine and ketamine, did not improve recovery in patients who had multilevel spine surgery.",2020,"Pain management within the initial 48 postoperative hours was not superior in analgesic pathway group: 48-h opioid consumption median (Q1, Q3) was 72 (48, 113) mg in the analgesic pathway group and 75 (50, 152)","['spine surgery patients', 'Spine Surgery', 'patients who had multilevel spine surgery', 'spine surgery', 'Adults having multilevel spine surgery who were at high risk for postoperative pain']","['placebo', 'acetaminophen and gabapentin', 'acetaminophen, gabapentin, ketamine, and lidocaineThe Quality of Recovery', 'placebos', 'Placebo', 'acetaminophen 1,000 mg and gabapentin 600 mg, an infusion of ketamine', 'lidocaine and ketamine', 'acetaminophen, gabapentin, and opioids', 'lidocaine', 'Multimodal Analgesic Regimen', 'nonopioid analgesics versus placebo']","['Quality of Recovery 15-questionnaire', 'Pain management', 'opioid use in morphine equivalents', 'mean ± SD Quality of Recovery score', 'Quality of Recovery, postoperative opioid consumption, and pain scores', 'Mean 48-h pain scores', 'verbal-response pain scores']","[{'cui': 'C0920347', 'cui_str': 'Procedure on spinal cord'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1154156', 'cui_str': 'gabapentin 600 MG'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0242937', 'cui_str': 'Non-opioid analgesic'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}]",,0.753593,"Pain management within the initial 48 postoperative hours was not superior in analgesic pathway group: 48-h opioid consumption median (Q1, Q3) was 72 (48, 113) mg in the analgesic pathway group and 75 (50, 152)","[{'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Maheshwari', 'Affiliation': 'From the Department of General Anesthesiology (K.M., R.A., D.T., S.R., M.M., S.M., A. Kurz) Department of Quantitative Health Sciences (N.M.) Department of Neurosurgery (A. Krishnaney, A.M.) Department of Pain Management (R.R.) Department of Outcomes Research (K.M., D.I.S., N.M., M.T., S.R., A. Kurz), Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Rafi', 'Initials': 'R', 'LastName': 'Avitsian', 'Affiliation': ''}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': ''}, {'ForeName': 'Natalya', 'Initials': 'N', 'LastName': 'Makarova', 'Affiliation': ''}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Tanios', 'Affiliation': ''}, {'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Raza', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Traul', 'Affiliation': ''}, {'ForeName': 'Shobana', 'Initials': 'S', 'LastName': 'Rajan', 'Affiliation': ''}, {'ForeName': 'Mariel', 'Initials': 'M', 'LastName': 'Manlapaz', 'Affiliation': ''}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Machado', 'Affiliation': ''}, {'ForeName': 'Ajit', 'Initials': 'A', 'LastName': 'Krishnaney', 'Affiliation': ''}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Machado', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Rosenquist', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Kurz', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003143']
1957,32496526,Evaluation of a Primary Open-Angle Glaucoma Prediction Model Using Long-term Intraocular Pressure Variability Data: A Secondary Analysis of 2 Randomized Clinical Trials.,"Importance


The contribution of long-term intraocular pressure (IOP) variability to the development of primary open-angle glaucoma is still controversial.
Objective


To assess whether long-term IOP variability data improve a prediction model for the development of primary open-angle glaucoma (POAG) in individuals with untreated ocular hypertension.
Design, Setting, and Participants


This post hoc secondary analysis of 2 randomized clinical trials included data from 709 of 819 participants in the observation group of the Ocular Hypertension Treatment Study (OHTS) followed up from February 28, 1994, to June 1, 2002, and 397 of 500 participants in the placebo group of the European Glaucoma Prevention Study (EGPS) followed up from January 1, 1997, to September 30, 2003. Data analyses were completed between January 1, 2019, and March 15, 2020.
Exposures


The original prediction model for the development of POAG included the following baseline factors: age, IOP, central corneal thickness, vertical cup-disc ratio, and pattern SD. This analysis tested whether substitution of baseline IOP with mean follow-up IOP, SD of IOP, maximum IOP, range of IOP, or coefficient of variation IOP would improve predictive accuracy.
Main Outcomes and Measures


The C statistic was used to compare the predictive accuracy of multivariable landmark Cox proportional hazards regression models for the development of POAG.
Results


Data from the OHTS consisted of 97 POAG end points from 709 of 819 participants (416 [58.7%] women; 177 [25.0%] African American and 490 [69.1%] white; mean [SD] age, 55.7 [9.59] years; median [range] follow-up, 6.9 [0.96-8.15] years). Data from the EGPS consisted of 44 POAG end points from 397 of 500 participants in the placebo group (201 [50.1%] women; 397 [100%] white; mean [SD] age, 57.8 [9.76] years; median [range] follow-up, 4.9 [1.45-5.76] years). The C statistic for the original prediction model was 0.741. When a measure of follow-up IOP was substituted for baseline IOP in this prediction model, the C statistics were as follows: mean follow-up IOP, 0.784; maximum IOP, 0.781; SD of IOP, 0.745; range of IOP, 0.741; and coefficient of variation IOP, 0.729. The C statistics in the EGPS were similarly ordered. No measure of IOP variability, when added to the prediction model that included mean follow-up IOP, age, central corneal thickness, vertical cup-disc ratio, and pattern SD, increased the C statistic by more than 0.007 in either cohort.
Conclusions and Relevance


Evidence from the OHTS and the EGPS suggests that long-term variability does not add substantial explanatory power to the prediction model as to which individuals with untreated ocular hypertension will develop POAG.",2020,"No measure of IOP variability, when added to the prediction model that included mean follow-up IOP, age, central corneal thickness, vertical cup-disc ratio, and pattern SD, increased the C statistic by more than 0.007 in either cohort.
","['African American and 490', '819 participants in the observation group of the Ocular Hypertension Treatment Study (OHTS) followed up from February 28, 1994, to June 1, 2002, and 397 of 500 participants in the placebo group of the European Glaucoma Prevention Study (EGPS) followed up from January 1, 1997, to September 30, 2003', 'individuals with untreated ocular hypertension', 'mean [SD] age, 55.7 [9.59] years; median [range] follow-up, 6.9 [0.96-8.15] years', 'group (201 [50.1%] women; 397 [100%] white; mean [SD] age, 57.8 [9.76] years; median [range] follow-up, 4.9 [1.45-5.76] years']","['Primary Open-Angle Glaucoma Prediction Model Using Long-term Intraocular Pressure Variability Data', 'long-term intraocular pressure (IOP', 'placebo']","['C statistic', 'central corneal thickness, vertical cup-disc ratio, and pattern SD', 'IOP variability']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0028840', 'cui_str': 'Ocular hypertension'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0730225', 'cui_str': '1997'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517826', 'cui_str': '6.9'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4517505', 'cui_str': '1.45'}]","[{'cui': 'C0339573', 'cui_str': 'Primary open angle glaucoma'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C1299676', 'cui_str': 'Vertical cup disc ratio'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}]",,0.230639,"No measure of IOP variability, when added to the prediction model that included mean follow-up IOP, age, central corneal thickness, vertical cup-disc ratio, and pattern SD, increased the C statistic by more than 0.007 in either cohort.
","[{'ForeName': 'Mae O', 'Initials': 'MO', 'LastName': 'Gordon', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Gao', 'Affiliation': 'Department of Surgery, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Julia Beiser', 'Initials': 'JB', 'LastName': 'Huecker', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Miller', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Margolis', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Kass', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Migliore', 'Affiliation': 'Policlinico di Monza University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'Valter', 'Initials': 'V', 'LastName': 'Torri', 'Affiliation': 'Department of Oncology, Istituto di Ricerche Farmacologiche ""Mario Negri,"" Milan, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.1902']
1958,31999886,Universal testing for group B streptococcus during pregnancy: need for a randomised trial.,,2020,,[],[],[],[],[],[],,0.203367,,"[{'ForeName': 'K F', 'Initials': 'KF', 'LastName': 'Walker', 'Affiliation': 'Division of Child Health, Obstetrics and Gynaecology, School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Morris', 'Affiliation': 'Department of Obstetrics and Gynaecology, Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Plumb', 'Affiliation': 'Group B Strep Support, Haywards Heath, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gray', 'Affiliation': ""Department of Microbiology, Birmingham Children's Hospital NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Thornton', 'Affiliation': 'Division of Child Health, Obstetrics and Gynaecology, School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Daniels', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16116']
1959,32202231,Effects of nicotine on microvascular responsiveness after nicotine satiety versus overnight nicotine abstinence.,,2020,,[],['nicotine'],['microvascular responsiveness'],[],"[{'cui': 'C0028040', 'cui_str': 'Nicotine'}]","[{'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}]",,0.0330574,,"[{'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Tam', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Bruseghini', 'Affiliation': 'Department of Molecular and Translational Medicine, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Capelli', 'Affiliation': 'Department of Physical Performances, Norwegian School of Sport Sciences, Oslo, Norway.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Baraldo', 'Affiliation': 'Department of Medicine, University of Udine, Udine, Italy.'}, {'ForeName': 'Cristiano', 'Initials': 'C', 'LastName': 'Chiamulera', 'Affiliation': 'Neuropsychopharmacology Lab, Department of Diagnostic and Public Health, University of Verona, Verona, Italy.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Zandonai', 'Affiliation': 'Department of Experimental Psychology, Mind, Brain and Behaviour Research Centre, Faculty of Psychology, University of Granada, Granada, Spain.'}]","Vascular medicine (London, England)",['10.1177/1358863X20906029']
1960,32224318,Perspectives on the model-based approach to proton therapy trials: A retrospective study of a lung cancer randomized trial.,"PURPOSE


The goal of this study was to assess whether a model-based approach applied retrospectively to a completed randomized controlled trial (RCT) would have significantly altered the selection of patients of the original trial, using the same selection criteria and endpoint for testing the potential clinical benefit of protons compared to photons.
METHODS AND MATERIALS


A model-based approach, based on three widely used normal tissue complication probability (NTCP) models for radiation pneumonitis (RP), was applied retrospectively to a completed non-small cell lung cancer RCT (NCT00915005). It was assumed that patients were selected by the model-based approach if their expected ΔNTCP value was above a threshold of 5%. The endpoint chosen matched that of the original trial, the first occurrence of severe (grade ≥3) RP.
RESULTS


Our analysis demonstrates that NTCP differences between proton and photon therapy treatments may be too small to support a model-based trial approach for lung cancer using RP as the normal tissue endpoint. The analyzed lung trial showed that less than 19% (32/165) of patients enrolled in the completed trial would have been enrolled in a model-based trial, prescribing photon therapy to all other patients. The number of patients enrolled was also found to be dependent on the type of NTCP model used for evaluating RP, with the three models enrolling 3%, 13% or 19% of patients. This result does show limitations in NTCP models which would affect the success of a model-based trial approach. No conclusion regarding the development of RP in patients randomized by the model-based approach could statistically be made.
CONCLUSIONS


Uncertainties in the outcome models to predict NTCP are the inherent drawback of a model-based approach to clinical trials. The impact of these uncertainties on enrollment in model-based trials depends on the predicted difference between the two treatment arms and on the set threshold for patient stratification. Our analysis demonstrates that NTCP differences between proton and photon therapy treatments may be too small to support a model-based trial approach for specific treatment sites, such as lung cancer, depending on the chosen normal tissue endpoint.",2020,"No conclusion regarding the development of RP in patients randomized by the model-based approach could statistically be made.
",[],[],[],[],[],[],,0.0324994,"No conclusion regarding the development of RP in patients randomized by the model-based approach could statistically be made.
","[{'ForeName': 'Aimee L', 'Initials': 'AL', 'LastName': 'McNamara', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital & Harvard Medical School, Boston, USA. Electronic address: amcnamara2@mgh.harvard.edu.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Hall', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital & Harvard Medical School, Boston, USA.'}, {'ForeName': 'Nadya', 'Initials': 'N', 'LastName': 'Shusharina', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital & Harvard Medical School, Boston, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ajdari', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital & Harvard Medical School, Boston, USA.'}, {'ForeName': 'Radhe', 'Initials': 'R', 'LastName': 'Mohan', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'Zhongxing', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Paganetti', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital & Harvard Medical School, Boston, USA.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.02.022']
1961,32221886,Bei Kreuzweh offen Placebo geben? : Schmerztherapie.,,2020,,[],[],[],[],[],[],,0.127742,,"[{'ForeName': 'H-C', 'Initials': 'HC', 'LastName': 'Diener', 'Affiliation': '.'}]",MMW Fortschritte der Medizin,['10.1007/s15006-020-0294-1']
1962,32228143,Comparison of video and in-hospital consultations during early in-home care for premature infants and their families: A randomised trial.,"INTRODUCTION


Early in-home care is increasingly being used in Scandinavian countries for clinically stable premature infants. Due to challenges with travel and hospital resources, alternative ways to support parents during early in-home care are being considered. The aim of this study was to test whether the proportion of mothers exclusively breastfeeding, parental confidence and mother-infant interaction increased after early in-home care with premature infants, and to compare the outcomes of in-home care involving the use of video communication and a mobile application with those of in-home care involving in-hospital consultations.
METHODS


This study was conducted in four neonatal wards offering premature infant in-home care in Denmark. Premature infants were randomised using 1:1 block randomisation. During early in-home care, families had planned consultations two to three times a week, during which they received support from nurses: the intervention group had video consultations, while the control group had in-hospital consultations.
RESULTS


The proportion of exclusively breastfeeding mothers at discharge was 66.7% in the intervention group vs 66% in the control group and decreased to 49.4% vs 55%, respectively, 1 month after discharge. No significant improvements were found in the intervention group compared with the control group. In the intervention group, some video consultations were changed to telephone consultations due to problems with the video function, or to in-hospital consultations due to infants' requirement for medical services. No significant differences in secondary outcomes were observed.
DISCUSSION


The study showed similar breastfeeding proportions at discharge. No unfavourable effects of video consultation compared with in-hospital consultation were found, indicating that video consultation could be a viable option and an important supplement during early in-home care.
TRIAL REGISTRATION


ClinicalTrials.gov ID: NCT02581800.",2020,,['premature infants and their families'],[],[],"[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0015576', 'cui_str': 'Family'}]",[],[],,0.0407363,,"[{'ForeName': 'Mai-Britt', 'Initials': 'MB', 'LastName': 'Hägi-Pedersen', 'Affiliation': 'Department of Paediatrics, Slagelse Hospital, 4200 Slagelse, Denmark.'}, {'ForeName': 'Ram B', 'Initials': 'RB', 'LastName': 'Dessau', 'Affiliation': 'Department of Clinical Microbiology, Slagelse Hospital, 4200 Slagelse, Denmark.'}, {'ForeName': 'Annelise', 'Initials': 'A', 'LastName': 'Norlyk', 'Affiliation': 'Department of Public Health, Faculty of Health, Aarhus University, 8000 Aarhus, Denmark.'}, {'ForeName': 'Hristo', 'Initials': 'H', 'LastName': 'Stanchev', 'Affiliation': 'Department of Paediatrics, Slagelse Hospital, 4200 Slagelse, Denmark.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Kronborg', 'Affiliation': 'Department of Public Health, Faculty of Health, Aarhus University, 8000 Aarhus, Denmark.'}]",Journal of telemedicine and telecare,['10.1177/1357633X20913411']
1963,25809680,"Consuming Beef vs. Soy Protein Has Little Effect on Appetite, Satiety, and Food Intake in Healthy Adults.","BACKGROUND


Although protein-rich plant foods have recently been touted as an equivalent to animal products, limited data exist regarding the effects of animal vs. plant proteins on appetite, satiety, and subsequent food intake.
OBJECTIVE


The objective was to determine whether a high-protein beef lunch alters the appetitive, hormonal, and neural signals controlling food intake regulation vs. a macronutrient and fiber-matched (MF) or serving size-matched (SS) soy lunch in healthy adults.
METHODS


A randomized, double-blind, crossover design study was completed in 21 adults (aged 23 ± 1 y; body mass index: 23.8 ± 0.6 kg/m²; mean ± SEM) to compare 400-kcal MF and SS lunches varying in protein quality. The MF lunches contained 24-g beef protein or 24-g soy protein, whereas the SS lunches contained 1 serving of beef (24-g protein/1-g fiber) or soy (14-g protein/5-g fiber). Pre- and postlunch appetite questionnaires and blood sampling were completed over an 8-h period until dinner was voluntarily requested. In addition, pre- and postlunch functional MRI brain scans were completed to assess neural activation in response to food stimuli.
RESULTS


On average, dinner was requested at ∼250 ± 20 min postlunch with no differences between beef vs. soy within the MF and SS conditions. Furthermore, no differences in hunger, fullness, peptide YY, or glucagon-like peptide-1 responses were observed after the beef vs. soy lunches within the MF and SS conditions. The SS beef meal led to reductions in anterior cingulate activation (-22 ± 6%) vs. soy (+7 ± 9%; P < 0.01) and greater reductions in insular activation (-30 ± 6%) vs. SS soy (-7 ± 10%; P < 0.01). The participants consumed ∼945 ± 78 kcal after the MF meals and 910 ± 74 kcal after the SS meals with no differences between beef vs. soy.
CONCLUSIONS


When comparing 2 high-quality protein sources, such as beef and soy, the type of protein consumed within a mixed meal elicited very little effect on appetite, satiety, and food intake in healthy adults.",2015,The SS beef meal led to reductions in anterior cingulate activation (-22 ± 6%) vs. soy (+7 ± 9%; P < 0.01) and greater reductions in insular activation (-30 ± 6%) vs. SS soy (-7 ± 10%; P < 0.01).,"['21 adults (aged 23 ± 1 y; body mass index: 23.8 ± 0.6 kg/m²; mean ± SEM) to compare 400-kcal MF and SS lunches varying in protein quality', 'Healthy Adults', 'healthy adults']","['Consuming Beef vs. Soy Protein', 'high-protein beef lunch alters the appetitive, hormonal, and neural signals controlling food intake regulation vs. a macronutrient and fiber-matched (MF) or serving size-matched (SS) soy lunch']","['insular activation', 'Appetite, Satiety, and Food Intake', 'Pre- and postlunch appetite questionnaires and blood sampling', 'anterior cingulate activation', 'appetite, satiety, and food intake', 'hunger, fullness, peptide YY, or glucagon-like peptide-1 responses']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4068883', 'cui_str': 'Zero point six'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0452849', 'cui_str': 'Beef'}, {'cui': 'C0074926', 'cui_str': 'Soy Proteins'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086311', 'cui_str': 'Intake Regulation, Food'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C3658325', 'cui_str': 'Serving Size'}]","[{'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0005834', 'cui_str': 'Blood Specimen Collection'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}, {'cui': 'C0070358', 'cui_str': 'PYY Peptide'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}]",,0.0513337,The SS beef meal led to reductions in anterior cingulate activation (-22 ± 6%) vs. soy (+7 ± 9%; P < 0.01) and greater reductions in insular activation (-30 ± 6%) vs. SS soy (-7 ± 10%; P < 0.01).,"[{'ForeName': 'Steve M', 'Initials': 'SM', 'LastName': 'Douglas', 'Affiliation': 'Department of Nutrition and Exercise Physiology, University of Missouri, Columbia, MO.'}, {'ForeName': 'Tyler R', 'Initials': 'TR', 'LastName': 'Lasley', 'Affiliation': 'Department of Nutrition and Exercise Physiology, University of Missouri, Columbia, MO.'}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Leidy', 'Affiliation': 'Department of Nutrition and Exercise Physiology, University of Missouri, Columbia, MO leidyh@health.missouri.edu.'}]",The Journal of nutrition,['10.3945/jn.114.206987']
1964,32139128,"Letter to the editor concerning ""Vicenti G, Bizzoca D, Nappi VS, et al. The impact of lag screw in the healing time of distal tibia fractures treated with minimally invasive plate osteosynthesis: A randomized clinical trial injury. 2020"".",,2020,,[],"['minimally invasive plate osteosynthesis', 'lag screw']",[],[],"[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}]",[],,0.0288424,,"[{'ForeName': 'Guojin', 'Initials': 'G', 'LastName': 'Hou', 'Affiliation': 'Department of Orthopaedic Surgery, Peking University Third Hospital, No 49, North Garden Rd, HaiDian District, Beijing 100191, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthopaedic Surgery, Peking University Third Hospital, No 49, North Garden Rd, HaiDian District, Beijing 100191, China. Electronic address: zhouf@bjmu.edu.cn.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Department of Orthopaedic Surgery, Peking University Third Hospital, No 49, North Garden Rd, HaiDian District, Beijing 100191, China.'}, {'ForeName': 'Zhongwei', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopaedic Surgery, Peking University Third Hospital, No 49, North Garden Rd, HaiDian District, Beijing 100191, China.'}]",Injury,['10.1016/j.injury.2020.02.123']
1965,32496566,Dose Timing of D-Cycloserine to Augment Exposure Therapy for Social Anxiety Disorder: A Randomized Clinical Trial.,"Importance


Findings suggest that the efficacy of D-cycloserine (DCS) for enhancing exposure therapy may be strongest when administered after sessions marked by low fear at the conclusion of exposure practice. These findings have prompted investigation of DCS dosing tailored to results of exposure sessions.
Objective


To compare tailored postsession DCS administration with presession DCS administration, postsession DCS administration, and placebo augmentation of exposure therapy for social anxiety disorder.
Design, Setting, and Participants


This double-blind randomized clinical trial involved adults with social anxiety disorder enrolled at 3 US university centers. Symptom severity was assessed at baseline, weekly during treatment, and at 1-week and 3-month follow-up. Data analysis was performed from September 2019 to March 2020.
Interventions


Participants completed a 5-session treatment and received pills commensurate with their condition assignment at sessions 2 through 5, which emphasized exposure practice.
Main Outcomes and Measures


Symptom severity was evaluated by the Liebowitz Social Anxiety Scale and Social Phobic Disorders-Severity Form as administered by independent evaluators.
Results


A total of 152 participants were enrolled (mean [SD] age, 29.24 [10.16] years; 84 men [55.26%]). Compared with placebo, presession and postsession conditions showed greater symptom improvement (b = -0.25; 95% CI, -0.37 to -0.13; P < .001; d = 1.07; and b = -0.20; 95% CI, -0.32 to -0.07; P = .002; d = 0.85) and lower symptom severity (b = -0.51; 95% CI, -0.81 to -0.21; P < .001; d = 0.76; and b = -0.49; 95% CI, -0.80 to -0.18; P = .002; d = 0.72) at 3-month follow-up. No differences were found between presession and postsession conditions. The tailored condition showed no advantage over placebo. Compared with the tailored condition, presession and postsession conditions evidenced greater decreases (b = -0.22; 95% CI, -0.34 to -0.10; P < .001; d = 0.94; and b = -0.17, 95% CI, -0.29 to -0.04; P = .008; d = 0.72) and lower symptom severity (b = -0.44, 95% CI, -0.73 to -0.14; P = .004; d = 0.64; and b = -0.41, 95% CI, -0.72 to -0.11; P = .008; d = 0.61) at 3-month follow-up.
Conclusions and Relevance


Administration of DCS enhanced exposure therapy for social anxiety disorder when given before or after the exposure session. However, the study failed to achieve the aim to develop a tailored clinical application.
Trial Registration


ClinicalTrials.gov Identifier: NCT02066792.",2020,"Compared with placebo, presession and postsession conditions showed greater symptom improvement (b = -0.25; 95% CI, -0.37 to -0.13; P < .001;","['Social Anxiety Disorder', 'A total of 152 participants were enrolled (mean [SD] age, 29.24', '10.16] years; 84 men [55.26', 'adults with social anxiety disorder enrolled at 3 US university centers']","['D-cycloserine (DCS', 'D-Cycloserine', '5-session treatment and received pills commensurate with their condition assignment at sessions 2 through 5, which emphasized exposure practice', 'presession DCS administration, postsession DCS administration, and placebo augmentation of exposure therapy', 'DCS enhanced exposure therapy', 'placebo']","['symptom improvement', 'Liebowitz Social Anxiety Scale and Social Phobic Disorders-Severity Form as administered by independent evaluators', 'Symptom severity', 'lower symptom severity']","[{'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517518', 'cui_str': '10.16'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0349231', 'cui_str': 'Phobia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",152.0,0.228555,"Compared with placebo, presession and postsession conditions showed greater symptom improvement (b = -0.25; 95% CI, -0.37 to -0.13; P < .001;","[{'ForeName': 'Jasper A J', 'Initials': 'JAJ', 'LastName': 'Smits', 'Affiliation': 'Institute for Mental Health Research, Department of Psychology, The University of Texas at Austin, Austin.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Pollack', 'Affiliation': 'Department of Psychiatry, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rosenfield', 'Affiliation': 'Department of Psychology, Southern Methodist University, Dallas, Texas.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Otto', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, Massachusetts.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Dowd', 'Affiliation': 'Department of Psychiatry, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Carpenter', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, Massachusetts.'}, {'ForeName': 'Christina D', 'Initials': 'CD', 'LastName': 'Dutcher', 'Affiliation': 'Institute for Mental Health Research, Department of Psychology, The University of Texas at Austin, Austin.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychiatry, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'Witcraft', 'Affiliation': 'Institute for Mental Health Research, Department of Psychology, The University of Texas at Austin, Austin.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Papini', 'Affiliation': 'Institute for Mental Health Research, Department of Psychology, The University of Texas at Austin, Austin.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Curtiss', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, Massachusetts.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Andrews', 'Affiliation': 'Department of Psychology, Southern Methodist University, Dallas, Texas.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Kind', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, Massachusetts.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Conroy', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, Massachusetts.'}, {'ForeName': 'Stefan G', 'Initials': 'SG', 'LastName': 'Hofmann', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, Massachusetts.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.6777']
1966,32493344,"Linagliptin, when compared to placebo, improves CD34+ve endothelial progenitor cells in type 2 diabetes subjects with chronic kidney disease taking metformin and/or insulin: a randomized controlled trial.","BACKGROUND


Endothelial Progenitor cells (EPCs) has been shown to be dysfunctional in both type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD) leading to poor regeneration of endothelium and renal perfusion. EPCs have been shown to be a robust cardiovascular disease (CVD) risk indicator. Cellular mechanisms of DPP4 inhibitors such as linagliptin (LG) on CVD risk, in patients with T2DM with established CKD has not been established. Linagliptin, a DPP4 inhibitor when added to insulin, metformin or both may improve endothelial dysfunction in a diabetic kidney disease (DKD) population.
METHODS


31 subjects taking metformin and/or Insulin were enrolled in this 12 weeks, double blind, randomized placebo matched trial, with 5 mg LG compared to placebo. Type 2 diabetes subjects (30-70 years old), HbA1c of 6.5-10%, CKD Stage 1-3 were included. CD34+ cell number, migratory function, gene expression along with vascular parameters such as arterial stiffness, biochemistry, resting energy expenditure and body composition were measured. Data were collected at week 0, 6 and 12. A mixed model regression analysis was done with p value < 0.05 considered significant.
RESULTS


A double positive CD34/CD184 cell count had a statistically significant increase (p < 0.02) as determined by flow cytometry in LG group where CD184 is SDF1a cell surface receptor. Though mRNA differences in CD34+ve was more pronounced CD34- cell mRNA analysis showed increase in antioxidants (superoxide dismutase 2 or SOD2, Catalase and Glutathione Peroxidase or GPX) and prominent endothelial markers (PECAM1, VEGF-A, vWF and NOS3). Arterial stiffness measures such as augmentation Index (AI) (p < 0.04) and pulse wave analysis (PWV) were improved (reduced in stiffness) in LG group. A reduction in LDL: HDL ratio was noted in treatment group (p < 0.04). Urinary exosome protein examining podocyte health (podocalyxin, Wilms tumor and nephrin) showed reduction or improvement.
CONCLUSIONS


In DKD subjects, Linagliptin promotes an increase in CXCR4 expression on CD34 + progenitor cells with a concomitant improvement in vascular and renal parameters at 12 weeks. Trial Registration Number NCT02467478 Date of Registration: 06/08/2015.",2020,Arterial stiffness measures such as augmentation Index (AI) (p < 0.04) and pulse wave analysis (PWV) were improved (reduced in stiffness) in LG group.,"['patients with T2DM with established CKD', 'Type 2 diabetes subjects (30-70\xa0years old), HbA1c of 6.5-10%, CKD Stage 1-3 were included', '31 subjects taking', 'type 2 diabetes subjects with chronic kidney disease taking']","['Linagliptin', 'linagliptin (LG', 'metformin', 'Endothelial Progenitor cells (EPCs', 'metformin and/or insulin', 'placebo']","['Arterial stiffness measures such as augmentation Index (AI', 'LDL: HDL ratio', 'endothelial dysfunction', 'CXCR4 expression', 'CD34+ cell number, migratory function, gene expression along with vascular parameters such as arterial stiffness, biochemistry, resting energy expenditure and body composition', 'pulse wave analysis (PWV', 'antioxidants (superoxide dismutase 2 or SOD2, Catalase and Glutathione Peroxidase or GPX) and prominent endothelial markers (PECAM1, VEGF-A, vWF and NOS3', 'CD34+ve endothelial progenitor cells']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C2316401', 'cui_str': 'Chronic kidney disease stage 1'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C2352110', 'cui_str': 'CXCR4 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0882849', 'cui_str': 'Cell positive for CD34 antigen'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0232901', 'cui_str': 'Migratory'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C3494430', 'cui_str': 'Pulse Wave Analysis'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0968147', 'cui_str': 'superoxide dismutase 2'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0205402', 'cui_str': 'Prominent'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0669365', 'cui_str': 'NOS3 protein, human'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}]",,0.207918,Arterial stiffness measures such as augmentation Index (AI) (p < 0.04) and pulse wave analysis (PWV) were improved (reduced in stiffness) in LG group.,"[{'ForeName': 'Hassan B', 'Initials': 'HB', 'LastName': 'Awal', 'Affiliation': 'The GW Medical Faculty Associates, 2300 M Street NW, Washington, DC, 20037, USA.'}, {'ForeName': 'Seshagiri Rao', 'Initials': 'SR', 'LastName': 'Nandula', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Cleyton C', 'Initials': 'CC', 'LastName': 'Domingues', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Fiona J', 'Initials': 'FJ', 'LastName': 'Dore', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Nabanita', 'Initials': 'N', 'LastName': 'Kundu', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Beda', 'Initials': 'B', 'LastName': 'Brichacek', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Fakhri', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Elzarki', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Neeki', 'Initials': 'N', 'LastName': 'Ahmadi', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Shauna', 'Initials': 'S', 'LastName': 'Safai', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Magan', 'Initials': 'M', 'LastName': 'Fosso', 'Affiliation': 'The GW Medical Faculty Associates, 2300 M Street NW, Washington, DC, 20037, USA.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Amdur', 'Affiliation': 'The GW Medical Faculty Associates, 2300 M Street NW, Washington, DC, 20037, USA.'}, {'ForeName': 'Sabyasachi', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'The GW Medical Faculty Associates, 2300 M Street NW, Washington, DC, 20037, USA. ssen1@gwu.edu.'}]",Cardiovascular diabetology,['10.1186/s12933-020-01046-z']
1967,31812110,Early score fluctuation and placebo response in a study of major depressive disorder.,"Early score fluctuation in double-blind, placebo-controlled studies may affect the reliability of the baseline measurement and adversely affect the eventual study outcome. We examined the effect of early score fluctuation during a 2-week double-blind placebo lead-in period in a phase II, double-blind, placebo-controlled trial of adjunctive s-adenosyl methionine (MSI-195) in MDD subjects who had had an inadequate response to ongoing antidepressant treatment. The overall study failed to meet its specified endpoints. We examined the score trajectories of all placebo-assigned subjects during the double-blind placebo lead-in period and subsequent 6-week treatment period. Placebo-assigned subjects with ≥20% HamD 17  or MADRS score fluctuations (improvement or worsening) during the double-blind placebo lead-in period (prior to randomization) had significantly higher rates of placebo response and remission at week 8 compared to subjects with <20% response. A post-hoc analysis of evaluable subjects taken from the ITT population that excluded subjects with ≥20% early score response yielded higher effect sizes for both the HamD 17  and MADRS sub-groups and statistical significance for MSI-195 over placebo in the MADRS sub-group (p = 0.012) with an effect size of 0.404. A reliable baseline measure is an asset for signal detection. These post-hoc findings suggest that study designs that anticipate and attempt to manage early response prior to randomization may yield more meaningful outcome data for trials of MDD and possibly other disorders as well.",2020,Placebo-assigned subjects with ≥20% HamD 17  or MADRS score fluctuations (improvement or worsening) during the double-blind placebo lead-in period (prior to randomization) had significantly higher rates of placebo response and remission at week 8 compared to subjects with <20% response.,"['MDD subjects who had had an inadequate response to ongoing antidepressant treatment', 'major depressive disorder']","['placebo-assigned subjects during the double-blind placebo', 'Placebo', 'adjunctive s-adenosyl methionine (MSI-195', 'placebo']","['rates of placebo response and remission', 'MADRS score fluctuations']","[{'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0025646', 'cui_str': 'L-methionine'}, {'cui': 'C4517624', 'cui_str': '195'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}]",,0.365683,Placebo-assigned subjects with ≥20% HamD 17  or MADRS score fluctuations (improvement or worsening) during the double-blind placebo lead-in period (prior to randomization) had significantly higher rates of placebo response and remission at week 8 compared to subjects with <20% response.,"[{'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Targum', 'Affiliation': 'Methylation Sciences Inc, 15300 Croydon Drive, Suite 300, Surrey, BC, V3S 0Z5, USA; Signant Health, Boston, MA, USA. Electronic address: sdtargum@yahoo.com.'}, {'ForeName': 'Beth R', 'Initials': 'BR', 'LastName': 'Cameron', 'Affiliation': 'Methylation Sciences Inc, 15300 Croydon Drive, Suite 300, Surrey, BC, V3S 0Z5, USA.'}, {'ForeName': 'Ludvina', 'Initials': 'L', 'LastName': 'Ferreira', 'Affiliation': 'Methylation Sciences Inc, 15300 Croydon Drive, Suite 300, Surrey, BC, V3S 0Z5, USA; PRA Health Sciences, Vancouver, DC, USA.'}, {'ForeName': 'I David', 'Initials': 'ID', 'LastName': 'MacDonald', 'Affiliation': 'Methylation Sciences Inc, 15300 Croydon Drive, Suite 300, Surrey, BC, V3S 0Z5, USA.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2019.11.014']
1968,32234533,Reducing an entrée portion size does not affect the amount of dessert consumed.,"BACKGROUND


Increasing portion size has been shown to increase energy intake. However, little is known about the effect of reducing portion size on subsequent consumption and the consequent energy intake.
OBJECTIVE


The purpose of this study was to examine the effect of decreasing portion size of an entrée on the amount of dessert consumed as a following course.
METHODS


A total of 81 participants were instructed to consume a lunch entrée and dessert ad libitum. The participants were given the same entrée and dessert on the same day of the week for four consecutive weeks. However, the entrée was reduced to 90%, 85%, 80%, and 75% of the amount they consumed in the first week of the study. Participants were randomized into four groups and were served the reduced entrée according to a Latin square design. Dessert was consumed ad libitum. In addition, subjects' hunger and satiety levels were assessed before the entrée, after the entrée, and after dessert.
RESULTS


Reducing portion size had no effect on the amount of dessert consumed despite the finding that measures of hunger and satiety indicated that participants experienced increased hunger at 80% and 75% portion reductions.
CONCLUSIONS


Reduction in the portion size of an entrée by up to 25% did not increase the amount of dessert consumed, despite an increase in perceived hunger at lower portion sizes. Further investigation is needed to study how much further portion size could be reduced with a sustained decrease in energy intake without compensation, as well as to examine potential interventions for portion control that could reduce daily energy intake.",2020,"CONCLUSIONS


Reduction in the portion size of an entrée by up to 25% did not increase the amount of dessert consumed, despite an increase in perceived hunger at lower portion sizes.",['81 participants'],[],"['perceived hunger', 'hunger', 'hunger and satiety levels', 'hunger and satiety']",[],[],"[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",81.0,0.0367898,"CONCLUSIONS


Reduction in the portion size of an entrée by up to 25% did not increase the amount of dessert consumed, despite an increase in perceived hunger at lower portion sizes.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Levitsky', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA; Department of Psychology, Cornell University, Ithaca, NY, USA. Electronic address: dal4@cornell.edu.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Agaronnik', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Wing', 'Initials': 'W', 'LastName': 'Zhong', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Colten', 'Initials': 'C', 'LastName': 'Morace', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Barre', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'John Jeshurun', 'Initials': 'JJ', 'LastName': 'Michael', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}]",Appetite,['10.1016/j.appet.2020.104684']
1969,32243613,Patient-reported outcome measures in multiple myeloma: Real-time reporting to improve care (My-PROMPT) - a pilot randomized controlled trial.,,2020,,[],[],['multiple myeloma: real-time reporting to improve care (My-PROMPT'],[],[],"[{'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",,0.132905,,"[{'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Moore', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Tracy A', 'Initials': 'TA', 'LastName': 'King', 'Affiliation': 'Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Erica M', 'Initials': 'EM', 'LastName': 'Wood', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rasa', 'Initials': 'R', 'LastName': 'Ruseckaite', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Klarica', 'Affiliation': 'Department of Malignant Haematology, The Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Spencer', 'Affiliation': 'Department of Malignant Haematology, The Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'P Joy', 'Initials': 'PJ', 'LastName': 'Ho', 'Affiliation': 'Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Quach', 'Affiliation': ""University of Melbourne, St Vincent's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'H Miles', 'Initials': 'HM', 'LastName': 'Prince', 'Affiliation': 'Epworth Healthcare and University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Zoe K', 'Initials': 'ZK', 'LastName': 'McQuilten', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}]",American journal of hematology,['10.1002/ajh.25815']
1970,32497260,Vitamin K supplementation for cystic fibrosis.,"BACKGROUND


Malabsorption and deficiency of fat-soluble vitamins K may occur in cystic fibrosis, a genetic disorder affecting multiple organs. Vitamin K is known to play an important role in both blood coagulation and bone formation, hence the role of supplementation of vitamin K in this category needs to be reviewed. This is an updated version of the review.
OBJECTIVES


To assess the effects of vitamin K supplementation in people with cystic fibrosis and to investigate the hypotheses that vitamin K will decrease deficiency-related coagulopathy, increase bone mineral density, decrease risk of fractures and improve quality of life in people with CF. Also to determine the optimal dose and route of administration of vitamin K for people with CF (for both routine and therapeutic use).
SEARCH METHODS


We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. Most recent search: 12 August 2019.
SELECTION CRITERIA


Randomised controlled trials of all preparations of vitamin K used as a supplement compared to either no supplementation (or placebo) at any dose or route and for any duration, in patients with cystic fibrosis.
DATA COLLECTION AND ANALYSIS


Two authors independently screened papers, extracted trial details and assessed their risk of bias. The quality of the evidence was assessed using the GRADE criteria.
MAIN RESULTS


Three trials (total 70 participants, aged 8 to 46 years) assessed as having a moderate risk of bias were included. One trial compared vitamin K to placebo, a second to no supplementation and the third compared two doses of vitamin K. No trial in either comparison reported our primary outcomes of coagulation and quality of life or the secondary outcomes of nutritional parameters and adverse events. Vitamin K versus control Two trials compared vitamin K to control, but data were not available for analysis. One 12-month trial (n = 38) compared 10 mg vitamin K daily or placebo in a parallel design and one trial (n = 18) was of cross-over design with no washout period and compared 5 mg vitamin K/week for four-weeks to no supplementation for four-weeks. Only the 12-month trial reported on the primary outcome of bone formation; we are very uncertain whether vitamin K supplementation has any effect on bone mineral density at the femoral hip or lumbar spine (very low-quality evidence). Both trials reported an increase in serum vitamin K levels and a decrease in undercarboxylated osteocalcin levels. The cross-over trial also reported that levels of proteins induced by vitamin K absence (PIVKA) showed a decrease and a return to normal following supplementation, but due to the very low-quality evidence we are not certain that this is due to the intervention. High-dose versus low-dose vitamin K One parallel trial (n = 14) compared 1 mg vitamin K/day to 5 mg vitamin K/day for four weeks. The trial did report that there did not appear to be any difference in serum undercarboxylated osteocalcin or vitamin K levels (very low-quality evidence). While the trial reported that serum vitamin K levels improved with supplementation, there was no difference between the high-dose and low-dose groups.
AUTHORS' CONCLUSIONS


There is very low-quality evidence of any effect of vitamin K in people with cystic fibrosis. While there is no evidence of harm, until better evidence is available the ongoing recommendations by national CF guidelines should be followed.",2020,The trial did report that there did not appear to be any difference in serum undercarboxylated osteocalcin or vitamin K levels (very low-quality evidence).,"['people with cystic fibrosis', 'cystic fibrosis', 'patients with cystic fibrosis', 'Three trials (total 70 participants, aged 8 to 46 years) assessed as having a moderate risk of bias were included', 'people with CF']","['Vitamin K', 'no supplementation (or placebo', 'vitamin K supplementation', 'vitamin K daily or placebo', 'vitamin K', 'Vitamin K supplementation', 'vitamin K to placebo']","['quality of life', 'bone mineral density', 'serum vitamin K levels', 'undercarboxylated osteocalcin levels', 'serum undercarboxylated osteocalcin or vitamin K levels', 'coagulation and quality of life or the secondary outcomes of nutritional parameters and adverse events', 'bone formation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332166', 'cui_str': 'Moderate risk of'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0042878', 'cui_str': 'Vitamin K'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0443768', 'cui_str': 'Serum vitamin K measurement'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042879', 'cui_str': 'Vitamin K measurement'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}]",70.0,0.547452,The trial did report that there did not appear to be any difference in serum undercarboxylated osteocalcin or vitamin K levels (very low-quality evidence).,"[{'ForeName': 'Vanitha A', 'Initials': 'VA', 'LastName': 'Jagannath', 'Affiliation': 'Department of Paediatrics, American Mission Hospital, Manama, Bahrain.'}, {'ForeName': 'Vidhu', 'Initials': 'V', 'LastName': 'Thaker', 'Affiliation': 'Division of Molecular Genetics and Department of Pediatrics, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Chang', 'Affiliation': 'Child Health Division, Menzies School of Health Research, Charles Darwin University, Darwin, Australia.'}, {'ForeName': 'Amy I', 'Initials': 'AI', 'LastName': 'Price', 'Affiliation': 'Research and Development, Empower 2 Go, Edmonton, UK.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD008482.pub6']
1971,32493473,"Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration in COVID-19 (REALIST-COVID-19): A structured summary of a study protocol for a randomised, controlled trial.","OBJECTIVES


The primary objective of the study is to assess the safety of a single intravenous infusion of Mesenchymal Stromal Cells (MSCs) in patients with Acute Respiratory Distress Syndrome (ARDS) due to COVID-19. Secondary objectives are to determine the effects of MSCs on important clinical outcomes, as described below.
TRIAL DESIGN


REALIST COVID 19 is a randomised, placebo-controlled, triple blinded trial.
PARTICIPANTS


The study will be conducted in Intensive Care Units in hospitals across the United Kingdom. Patients with moderate to severe ARDS as defined by the Berlin definition, receiving invasive mechanical ventilation and with a diagnosis of COVID-19 based on clinical diagnosis or PCR test will be eligible. Patients will be excluded for the following reasons: more than 72 hours from the onset of ARDS; age < 16 years; patient known to be pregnant; major trauma in previous 5 days; presence of any active malignancy (other than non-melanoma skin cancer); WHO Class III or IV pulmonary hypertension; venous thromboembolism currently receiving anti-coagulation or within the past 3 months; patient receiving extracorporeal life support; severe chronic liver disease (Child-Pugh > 12); Do Not Attempt Resuscitation order in place; treatment withdrawal imminent within 24 hours; prisoners; declined consent; non-English speaking patients or those who do not adequately understand verbal or written information unless an interpreter is available; previously enrolled in the REALIST trial.
INTERVENTION AND COMPARATOR


Intervention: Allogeneic donor CD362 enriched human umbilical cord derived mesenchymal stromal cells (REALIST ORBCEL-C) supplied as sterile, single-use cryopreserved cell suspension of a fixed dose of 400 x10 6  cells in 40ml volume, to be diluted in Plasma-Lyte 148 to a total volume of 200mls for administration. Comparator (placebo): Plasma-Lyte 148 Solution for Infusion (200mls). The cellular product (REALIST ORBCEL-C) was developed and patented by Orbsen Therapeutics.
MAIN OUTCOMES


The primary safety outcome is the incidence of serious adverse events. The primary efficacy outcome is Oxygenation Index (OI) at day 7. Secondary outcomes include: OI at days 4 and 14; respiratory compliance, driving pressure and PaO 2 /FiO 2  ratio (PF ratio) at days 4, 7 and 14; Sequential Organ Failure Assessment (SOFA) score at days 4, 7 and 14; extubation and reintubation; ventilation free days at day 28; duration of mechanical ventilation; length of ICU and hospital stay; 28-day and 90-day mortality.
RANDOMISATION


After obtaining informed consent, patients will be randomised via a centralised automated 24-hour telephone or web-based randomisation system (CHaRT, Centre for Healthcare Randomised Trials, University of Aberdeen). Randomisation will be stratified by recruitment centre and by vasopressor use and patients will be allocated to REALIST ORBCEL-C or placebo control in a 1:1 ratio.
BLINDING (MASKING)


The investigator, treating physician, other members of the site research team and participants will be blinded. The cell therapy facility and clinical trials pharmacist will be unblinded to facilitate intervention and placebo preparation. The unblinded individuals will keep the treatment information confidential. The infusion bag will be masked at the time of preparation and will be administered via a masked infusion set.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


A sample size of 60 patients with 30 patients randomised to the intervention and 30 to the control group. If possible, recruitment will continue beyond 60 patients to provide more accurate and definitive trial results. The total number of patients recruited will depend on the pandemic and be guided by the data monitoring and ethics committee (DMEC).
TRIAL STATUS


REALIST Phase 1 completed in January 2020 prior to the COVID-19 pandemic. This was an open label dose escalation study of REALIST ORBCEL-C in patients with ARDS. The COVID-19 pandemic emerged as REALIST Phase 2 was planned to commence and the investigator team decided to repurpose the Phase 2 trial as a COVID-19 specific trial. This decision was discussed and approved by the Trial Steering Committee (TSC) and DMEC. Submissions were made to the Research Ethics Committee (REC) and MHRA to amend the protocol to a COVID-19 specific patient population and the protocol amendment was accepted by the REC on 27 th  March 2020 and MHRA on 30 th  March 2020 respectively. Other protocol changes in this amendment included an increase in the time of onset of ARDS from 48 to 72 hours, inclusion of clinical outcomes as secondary outcomes, the provision of an option for telephone consent, an indicative sample size and provision to continue recruitment beyond this indicative sample size. The current protocol in use is version 4.0 23.03.2020 (Additional file 1). Urgent Public Health status was awarded by the NIHR on 2 April 2020 and the trial opened to recruitment and recruited the first participant the same day. At the time of publication the trial was open to recruitment at 5 sites across the UK (Belfast Health and Social Care Trust, King's College London, Guys and St Thomas' Hospital London, Birmingham Heartlands Hospital and the Queen Elizabeth Hospital Birmingham) and 12 patients have been recruited across these sites. Additional sites are planned to open and appropriate approvals for these are being obtained. It is estimated recruitment will continue for 6 months.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03042143 (Registered 3 Feb 2017). EudraCT 2017-000585-33 (Registered 28 Nov 2017).
FULL PROTOCOL


The full protocol (version 4.0 23.03.2020) is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).",2020,"Secondary outcomes include: OI at days 4 and 14; respiratory compliance, driving pressure and PaO 2 /FiO 2  ratio (PF ratio) at days 4, 7 and 14; Sequential Organ Failure Assessment (SOFA) score at days 4, 7 and 14; extubation and reintubation; ventilation free days at day 28; duration of mechanical ventilation; length of ICU and hospital stay; 28-day and 90-day mortality.
RANDOMISATION


After obtaining informed consent, patients will be randomised via a centralised automated 24-hour telephone or web-based randomisation system (CHaRT, Centre for Healthcare Randomised Trials, University of Aberdeen).","['2017-000585-33', 'Intensive Care Units in hospitals across the United Kingdom', 'Patients with moderate to severe ARDS', '60 patients with 30 patients randomised to the intervention and 30 to the control group', 'REALIST Phase 1 completed in January 2020 prior to the COVID-19 pandemic', 'Patients will be excluded for the following reasons: more than 72 hours from the onset of ARDS; age < 16 years; patient known to be pregnant; major trauma in previous 5 days; presence of any active malignancy (other than non-melanoma skin cancer); WHO Class III or IV pulmonary hypertension; venous thromboembolism currently receiving anti-coagulation or within the past 3 months; patient receiving extracorporeal life support; severe chronic liver disease (Child-Pugh > 12', 'patients with ARDS', 'English speaking patients or those who do not adequately understand verbal or written information unless an interpreter is available; previously enrolled in the REALIST trial', 'patients with Acute Respiratory Distress Syndrome (ARDS']","['Comparator (placebo', 'Allogeneic donor CD362', 'Stromal Cell Administration in COVID-19 (REALIST-COVID-19', 'EudraCT', 'Mesenchymal Stromal Cells (MSCs', 'placebo']","['time of onset of ARDS', ' OI at days 4 and 14; respiratory compliance, driving pressure and PaO 2 /FiO 2  ratio (PF ratio) at days 4, 7 and 14; Sequential Organ Failure Assessment (SOFA) score at days 4, 7 and 14; extubation and reintubation; ventilation free days at day 28; duration of mechanical ventilation; length of ICU and hospital stay; 28-day and 90-day mortality', 'incidence of serious adverse events', 'Oxygenation Index (OI']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0332677', 'cui_str': 'Major injury'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0699893', 'cui_str': 'Skin carcinoma'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0341439', 'cui_str': 'Chronic liver disease'}, {'cui': 'C4050412', 'cui_str': 'Child-Pugh score'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0150646', 'cui_str': 'Interpreter'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0162597', 'cui_str': 'Stromal Cells'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C3178844', 'cui_str': 'Mesenchymal Stromal Cells'}]","[{'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0860359', 'cui_str': 'Reintubate'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",60.0,0.415432,"Secondary outcomes include: OI at days 4 and 14; respiratory compliance, driving pressure and PaO 2 /FiO 2  ratio (PF ratio) at days 4, 7 and 14; Sequential Organ Failure Assessment (SOFA) score at days 4, 7 and 14; extubation and reintubation; ventilation free days at day 28; duration of mechanical ventilation; length of ICU and hospital stay; 28-day and 90-day mortality.
RANDOMISATION


After obtaining informed consent, patients will be randomised via a centralised automated 24-hour telephone or web-based randomisation system (CHaRT, Centre for Healthcare Randomised Trials, University of Aberdeen).","[{'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Gorman', 'Affiliation': ""Wellcome Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry and Biomedical Science Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Manu', 'Initials': 'M', 'LastName': 'Shankar-Hari', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust London and School of Immunology and Microbial Sciences, King's College London, London, UK.""}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Hopkins', 'Affiliation': ""Research and Development lead in Critical Care, Kings Trauma Centre, King's College London, London, UK.""}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Tunnicliffe', 'Affiliation': 'Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'Gavin D', 'Initials': 'GD', 'LastName': 'Perkins', 'Affiliation': 'University of Warwick, Coventry, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Silversides', 'Affiliation': 'Belfast Health and Social Care Trust, Belfast, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'McGuigan', 'Affiliation': 'Royal Victoria Hospital, Belfast, UK.'}, {'ForeName': 'Colette', 'Initials': 'C', 'LastName': 'Jackson', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast, UK.'}, {'ForeName': 'Roisin', 'Initials': 'R', 'LastName': 'Boyle', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'McFerran', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast, UK.'}, {'ForeName': 'Cliona', 'Initials': 'C', 'LastName': 'McDowell', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Campbell', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast, UK.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'McFarland', 'Affiliation': 'Belfast Health and Social Care Trust, Belfast, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Smythe', 'Affiliation': 'NHS Blood and Transplant, Birmingham, UK.'}, {'ForeName': 'Jacqui', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'NHS Blood and Transplant, Birmingham, UK.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Williams', 'Affiliation': 'Independent Public and Patient Representative, Sherborne, UK.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Curley', 'Affiliation': 'Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Laffey', 'Affiliation': 'National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Clarke', 'Affiliation': ""School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': ""O'Kane"", 'Affiliation': ""Wellcome Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry and Biomedical Science Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'McAuley', 'Affiliation': ""Wellcome Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry and Biomedical Science Queen's University Belfast, Belfast, UK. d.f.mcauley@qub.ac.uk.""}]",Trials,['10.1186/s13063-020-04416-w']
1972,32499263,"Monitoring patients with acute dyspnoea with a serial focused ultrasound of the heart and the lungs (MODUS): a protocol for a multicentre, randomised, open-label, pragmatic and controlled trial.","INTRODUCTION


Among patients admitted to an emergency department, dyspnoea is one of the most common symptoms. Patients with dyspnoea have high mortality and morbidity. Therefore, novel methods to monitor the patients are warranted. The aim is to investigate whether therapy guided by monitoring patients with acute dyspnoea with serial ultrasound examinations of the heart and the lungs together with standard care can change the severity of dyspnoea compared with treatment guided by standard monitoring alone.
METHODS AND ANALYSIS


The study will be conducted as a multicentre, randomised, pragmatic, open-label and controlled trial where patients admitted with acute dyspnoea to an emergency ward will be randomised into a standard care group and a serial ultrasound group with 103 patients in each. All patients will be examined with an ultrasound of the heart and the lungs upfront. In addition, the patients in the serial ultrasound group will be examined with an ultrasound of the heart and lungs two more times to guide further therapy during the admittance. The primary outcome is a change in dyspnoea on a verbal scale. After discharge, the patients are followed for 1 year to assess the number of readmissions, death and length of hospital stay.
ETHICS AND DISSEMINATION


The trial is conducted in accordance with the Declaration of Helsinki and approved by The Regional Committee on Health Research Ethics for Region Zealand, Denmark (identifier SJ-744). Data handling agreement with participating centres has been made (identifier REG-056-2019). The General Data Protection Regulation and the Danish Data Protection Act will be respected. The results of the trial will be reported in peer-reviewed scientific journals regardless of the outcomes.
TRIAL REGISTRATION NUMBER


NCT04091334.",2020,"After discharge, the patients are followed for 1 year to assess the number of readmissions, death and length of hospital stay.
","['Monitoring patients with acute dyspnoea with a serial focused ultrasound of the heart and the lungs (MODUS', 'Patients with dyspnoea have high mortality and morbidity', 'patients admitted with acute dyspnoea to an emergency ward will be randomised into a standard care group and a serial ultrasound group with 103 patients in each', 'patients with acute dyspnoea with serial ultrasound examinations of the heart and the lungs together with standard care']",[],"['change in dyspnoea on a verbal scale', 'number of readmissions, death and length of hospital stay']","[{'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0743323', 'cui_str': 'Acute dyspnea'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C1449955', 'cui_str': 'Modus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0948501', 'cui_str': 'Ultrasound examination'}]",[],"[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.0722347,"After discharge, the patients are followed for 1 year to assess the number of readmissions, death and length of hospital stay.
","[{'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Arvig', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark doktorarvig@gmail.com.'}, {'ForeName': 'Annmarie T', 'Initials': 'AT', 'LastName': 'Lassen', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Gæde', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Christian B', 'Initials': 'CB', 'LastName': 'Laursen', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-034373']
1973,32499503,Reconsolidation-based treatment for fear of public speaking: a systematic pilot study using propranolol.,"Pharmacological manipulation of memory reconsolidation opens up promising new avenues for anxiety disorder treatment. However, few studies have directly investigated reconsolidation-based approaches in subclinical or clinical populations, leaving optimal means of fear memory reactivation unknown. We conducted a systematic pilot study to assess whether a reconsolidation-based treatment could tackle public speaking anxiety in a subclinical sample (N = 60). As lab studies indicate that the duration of reactivation may be important for inducing reconsolidation, we investigated several speech lengths to help inform further translational efforts. Participants underwent a stress-inducing speech task composed of 3-min preparation, and from 0 to 9 min of public speaking, in 1-min increments. They then received either 40 mg of propranolol (n = 40) or placebo (n = 20), double-blind, allocated 4:2 for each speech duration. Participants performed a second speech 1 week post treatment, and were followed up with questionnaires 1- and 3 months later. Both self-reported speech distress and questionnaire measures of public speaking anxiety showed clear reductions following treatment. However, propranolol did not reliably outperform placebo, regardless of speech duration at treatment. Physiological responses (heart rate and salivary cortisol) to the public speaking task remained stable from treatment to test. These findings highlight the challenges facing the translation of laboratory research on memory reconsolidation into clinical interventions. Lack of explicit controls for factors beyond duration, such as 'prediction error', could explain these null findings, but positive results in clinical interventions are needed to demonstrate that taking such factors into account can deliver the promises of reconsolidation-based therapy.",2020,Physiological responses (heart rate and salivary cortisol) to the public speaking task remained stable from treatment to test.,"['fear of public speaking', 'tackle public speaking anxiety in a subclinical sample (N\u2009=\u200960']","['stress-inducing speech task composed of 3-min preparation, and from 0 to 9\u2009min of public speaking', 'propranolol', 'placebo']",['Physiological responses (heart rate and salivary cortisol'],"[{'cui': 'C0424169', 'cui_str': 'Fear of public speaking'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0392359', 'cui_str': 'Public Speaking'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}]",,0.0293513,Physiological responses (heart rate and salivary cortisol) to the public speaking task remained stable from treatment to test.,"[{'ForeName': 'James W B', 'Initials': 'JWB', 'LastName': 'Elsey', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands. j.w.b.elsey@uva.nl.'}, {'ForeName': 'Anna I', 'Initials': 'AI', 'LastName': 'Filmer', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Harriet R', 'Initials': 'HR', 'LastName': 'Galvin', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'Kurath', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Linos', 'Initials': 'L', 'LastName': 'Vossoughi', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Linnea S', 'Initials': 'LS', 'LastName': 'Thomander', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Zavodnik', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Merel', 'Initials': 'M', 'LastName': 'Kindt', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands.'}]",Translational psychiatry,['10.1038/s41398-020-0857-z']
1974,32503004,"Effect of exercise training on insulin sensitivity, hyperinsulinemia and ectopic fat in black South African women: a randomized controlled trial.","Objective


We investigated the effects of a 12-week exercise intervention on insulin sensitivity (SI) and hyperinsulinemia and associated changes in regional and ectopic fat.
Research design and methods


Healthy, black South African women with obesity (mean age 23 ± 3.5 years) and of isiXhosa ancestry were randomised into a 12-week aerobic and resistance exercise training group (n = 23) and a no exercise group (control, n = 22). Pre and post-intervention testing included assessment of SI, insulin response to glucose (AIRg), insulin secretion rate (ISR), hepatic insulin extraction (FEL) and disposition index (DI) (AIRg × SI) (frequently sampled i.v. glucose tolerance test); fat mass and regional adiposity (dual-energy X-ray absorptiometry); hepatic, pancreatic and skeletal muscle fat content and abdominal s.c. and visceral adipose tissue volumes (MRI).
Results


Exercise training increased VO2peak (mean ± s.d.: 24.9 ± 2.42 to 27.6 ± 3.39 mL/kg/min, P < 0.001), SI (2.0 (1.2-2.8) to 2.2 (1.5-3.7) (mU/l)-1 min-1, P = 0.005) and DI (median (interquartile range): 6.1 (3.6-7.1) to 6.5 (5.6-9.2) × 103 arbitrary units, P = 0.028), and decreased gynoid fat mass (18.5 ± 1.7 to 18.2 ± 1.6%, P < 0.001) and body weight (84.1 ± 8.7 to 83.3 ± .9.7 kg, P = 0.038). None of these changes were observed in the control group, but body weight increased (P = 0.030). AIRg, ISR and FEL, VAT, SAT and ectopic fat were unaltered after exercise training. The increase in SI and DI were not associated with changes in regional or ectopic fat.
Conclusion


Exercise training increased SI independent from changes in hyperinsulinemia and ectopic fat, suggesting that ectopic fat might not be a principal determinant of insulin resistance in this cohort.",2020,"None of these changes were observed in the control group, but body weight increased (P = 0.030).","['black South African women', 'Healthy, black South African women with obesity (mean', 'age 23 ± 3.5 years) and of isiXhosa ancestry']","['exercise training', 'Conclusion\n\n\nExercise training', 'no exercise', 'exercise intervention', 'aerobic and resistance exercise training']","['insulin sensitivity (SI) and hyperinsulinemia', 'hyperinsulinemia and ectopic fat', 'body weight', 'AIRg, ISR and FEL, VAT, SAT and ectopic fat', 'insulin sensitivity, hyperinsulinemia and ectopic fat', 'SI', 'SI and DI', 'gynoid fat mass', 'assessment of SI, insulin response to glucose (AIRg), insulin secretion rate (ISR), hepatic insulin extraction (FEL) and disposition index (DI) (AIRg × SI', 'glucose tolerance test); fat mass and regional adiposity']","[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0340464', 'cui_str': 'Ectopic beats'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0272199', 'cui_str': 'Familial hemophagocytic lymphohistiocytosis'}, {'cui': 'C0042427', 'cui_str': 'Vatican City'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0017741', 'cui_str': 'Glucose tolerance test'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",,0.0228643,"None of these changes were observed in the control group, but body weight increased (P = 0.030).","[{'ForeName': 'Melony C', 'Initials': 'MC', 'LastName': 'Fortuin-de Smidt', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Mendham', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Hauksson', 'Affiliation': 'Department of Radiation Sciences, Radiation Physics and Biomedical Engineering, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Olah', 'Initials': 'O', 'LastName': 'Hakim', 'Affiliation': ""Department of Diabetes, School of Life Course Sciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.""}, {'ForeName': 'Darko', 'Initials': 'D', 'LastName': 'Stefanovski', 'Affiliation': 'Department of Clinical Studies, New Bolton Center, University of Pennsylvania, School of Veterinary Medicine, Kennett Square, Pennsylvania, USA.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Clamp', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Lindokuhle', 'Initials': 'L', 'LastName': 'Phiri', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Swart', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Louise M', 'Initials': 'LM', 'LastName': 'Goff', 'Affiliation': ""Department of Diabetes, School of Life Course Sciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.""}, {'ForeName': 'Lisa K', 'Initials': 'LK', 'LastName': 'Micklesfield', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': 'Division of Metabolism, Endocrinology and Nutrition, Department of Medicine, Veterans Affairs Puget Sound Health Care System and University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Olsson', 'Affiliation': 'Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Julia H', 'Initials': 'JH', 'LastName': 'Goedecke', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}]",European journal of endocrinology,['10.1530/EJE-19-0957']
1975,32503005,Psychological well-being and personality in relation to weight loss following behavioral modification intervention in obese women with polycystic ovary syndrome: a randomized controlled trial.,"Objective


Little is known about how lifestyle affects psychological well-being in overweight women with polycystic ovary syndrome (PCOS). We investigated the effects of behavioral modification on psychological well-being and the impact of well-being and personality traits on successful weight loss.
Design


A 4-month randomized controlled trial with a 12-month follow-up at a University Hospital.
Methods


Sixty-eight women with PCOS, aged 18 to 40 years with a BMI ≥27 kg/m2, were randomized (1:1) into a behavioral modification program (intervention) or minimal intervention (control). The outcome measures were the psychological well being index and the Swedish universities scales of personality.
Results


At baseline, 60% had a global psychological well being index corresponding to severe distress and 40% to moderate distress. There was no significant change in mean global well-being score at 4 months within or between groups. However, after 4 months, the intervention group expressed less anxiety (P = .035), higher general health (P = .012) and lower depressed mood (P = .033). Anxiety and general health tended to differ between groups (P = .06, respectively) favoring intervention. In the whole population, women achieving ≥5% weight loss at 12 months (n = 18) were less anxious at baseline compared to those who had not (P = .004). Personality trait-analysis showed that the weight-loss group had higher social desirability (P = .033) and lower embitterment (P = .023).
Conclusions


Psychological well-being is severely impacted in overweight women with PCOS. Behavioral modification can positively impact dimensions of well-being, although not fully significant, compared to control treatment. Personality factors could contribute to the understanding of successful weight loss.",2020,"However, after 4 months, the intervention group expressed less anxiety (P = .035), higher general health (P = .012) and lower depressed mood (P = .033).","['obese women with polycystic ovary syndrome', 'overweight women with polycystic ovary syndrome (PCOS', 'Methods\n\n\nSixty-eight women with PCOS, aged 18 to 40 years with a BMI ≥27 kg/m2', 'overweight women with PCOS']","['behavioral modification intervention', 'behavioral modification program (intervention) or minimal intervention (control']","['global psychological well being index corresponding to severe distress', 'anxiety', 'weight loss', 'general health', 'Anxiety and general health', 'mean global well-being score', 'psychological well being index and the Swedish universities scales of personality', 'social desirability']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003944', 'cui_str': 'As If Personality'}, {'cui': 'C0037408', 'cui_str': 'Social Desirability'}]",68.0,0.0840157,"However, after 4 months, the intervention group expressed less anxiety (P = .035), higher general health (P = .012) and lower depressed mood (P = .033).","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Oberg', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Lundell', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Liselott', 'Initials': 'L', 'LastName': 'Blomberg', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Sebastian B', 'Initials': 'SB', 'LastName': 'Gidlöf', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Petra Tollet', 'Initials': 'PT', 'LastName': 'Egnell', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Angelica Lindén', 'Initials': 'AL', 'LastName': 'Hirschberg', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}]",European journal of endocrinology,['10.1530/EJE-20-0066']
1976,32503869,Psychosocial consequences of false positives in the Danish Lung Cancer CT Screening Trial: a nested matched cohort study.,"OBJECTIVES


Lung cancer CT screening can reduce lung cancer mortality, but high false-positive rates may cause adverse psychosocial consequences. The aim was to analyse the psychosocial consequences of false-positive lung cancer CT screening using the lung cancer screening-specific questionnaire, Consequences of Screening in Lung Cancer (COS-LC).
DESIGN AND SETTING


This study was a matched cohort study, nested in the randomised Danish Lung Cancer Screening Trial (DLCST).
PARTICIPANTS


Our study included all 130 participants in the DLCST with positive CT results in screening rounds 2-5, who had completed the COS-LC questionnaire. Participants were split into a true-positive and a false-positive group and were then matched 1:2 with a control group (n=248) on sex, age (±3 years) and the time of screening for the positive CT groups or clinic visit for the control group. The true positives and false positives were also matched 1:2 with participants with negative CT screening results (n=252).
PRIMARY OUTCOMES


Primary outcomes were psychosocial consequences measured at five time points.
RESULTS


False positives experienced significantly more negative psychosocial consequences in seven outcomes at 1 week and in three outcomes at 1 month compared with the control group and the true-negative group (mean ∆ score >0 and p<0.001). True positives experienced significantly more negative psychosocial consequences in one outcome at 1 week (mean ∆ score 2.86 (95% CI 1.01 to 4.70), p=0.0024) and in five outcomes at 1 month (mean ∆ score >0 and p<0.004) compared with the true-negative group and the control group. No long-term psychosocial consequences were identified either in false positives or true positives.
CONCLUSIONS


Receiving a false-positive result in lung cancer screening was associated with negative short-term psychosocial consequences. These findings contribute to the evidence on harms of screening and should be taken into account when considering implementation of lung cancer screening programmes.
TRIAL REGISTRATION NUMBER


NCT00496977.",2020,"True positives experienced significantly more negative psychosocial consequences in one outcome at 1 week (mean ∆ score 2.86 (95% CI 1.01 to 4.70), p=0.0024) and in five outcomes at 1 month (mean ∆ score >0 and p<0.004) compared with the true-negative group and the control group.","['Our study included all 130 participants in the DLCST with positive CT results in screening rounds 2-5, who had completed the COS-LC questionnaire', 'Participants were split into a true-positive and a false-positive group and were then matched 1:2 with a control group (n=248) on sex, age (±3 years) and the time of screening for the positive CT groups or clinic visit for the control group']",['false-positive lung cancer CT screening'],"['lung cancer mortality', 'psychosocial consequences measured at five time points', 'lung cancer screening', 'Psychosocial consequences of false positives', 'true positives and false positives', 'negative psychosocial consequences', 'false positives or true positives']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205559', 'cui_str': 'True positive'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}]","[{'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0205559', 'cui_str': 'True positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",,0.0269201,"True positives experienced significantly more negative psychosocial consequences in one outcome at 1 week (mean ∆ score 2.86 (95% CI 1.01 to 4.70), p=0.0024) and in five outcomes at 1 month (mean ∆ score >0 and p<0.004) compared with the true-negative group and the control group.","[{'ForeName': 'Jakob Fraes', 'Initials': 'JF', 'LastName': 'Rasmussen', 'Affiliation': 'The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Volkert', 'Initials': 'V', 'LastName': 'Siersma', 'Affiliation': 'The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Malmqvist', 'Affiliation': 'The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark jessica.malmqvist@sund.ku.dk.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Brodersen', 'Affiliation': 'The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-034682']
1977,32503946,Overall survival at 5 years of follow-up in a phase III trial comparing ipilimumab 10 mg/kg with 3 mg/kg in patients with advanced melanoma.,"BACKGROUND


We have previously reported significantly longer overall survival (OS) with ipilimumab 10 mg/kg versus ipilimumab 3 mg/kg in patients with advanced melanoma, with higher incidences of adverse events (AEs) at 10 mg/kg. This follow-up analysis reports a 5-year update of OS and safety.
METHODS


This randomized, multicenter, double-blind, phase III trial included patients with untreated or previously treated unresectable stage III or IV melanoma. Patients were randomly assigned (1:1) to ipilimumab 10 mg/kg or 3 mg/kg every 3 weeks for 4 doses. The primary end point was OS.
RESULTS


At a minimum follow-up of 61 months, median OS was 15.7 months (95% CI 11.6 to 17.8) at 10 mg/kg and 11.5 months (95% CI 9.9 to 13.3) at 3 mg/kg (HR 0.84, 95% CI 0.71 to 0.99; p=0.04). In a subgroup analysis, median OS of patients with asymptomatic brain metastasis was 7.0 months (95% CI 4.0 to 12.8) in the 10 mg/kg group and 5.7 months (95% CI 4.2 to 7.0) in the 3 mg/kg group. In patients with wild-type or mutant  BRAF  tumors, median OS was 13.8 months (95% CI 10.2 to 17.0) and 33.2 months (95% CI 19.4 to 45.2) in the 10 mg/kg group, and 11.2 months (95% CI 9.2 to 13.8) and 19.7 months (95% CI 11.6 to 25.3) in the 3 mg/kg group, respectively. The incidence of grade 3/4 treatment-related AEs was 36% in the 10 mg/kg group vs 20% in the 3 mg/kg group, and deaths due to treatment-related AEs occurred in four (1%) and two patients (1%), respectively.
CONCLUSIONS


This 61-month follow-up of a phase III trial showed sustained long-term survival in patients with advanced melanoma who started metastatic treatment with ipilimumab monotherapy, and confirmed the significant benefit for those who received ipilimumab 10 mg/kg vs 3 mg/kg. These results suggest the emergence of a plateau in the OS curve, consistent with previous ipilimumab studies.
TRIAL REGISTRATION NUMBER


NCT01515189.",2020,"In patients with wild-type or mutant  BRAF  tumors, median OS was 13.8 months (95% CI 10.2 to 17.0) and 33.2 months (95% CI 19.4 to 45.2) in the 10 mg/kg group, and 11.2 months (95% CI 9.2 to 13.8) and 19.7 months (95% CI 11.6 to 25.3) in the 3 mg/kg group, respectively.","['patients with advanced melanoma', 'patients with untreated or previously treated unresectable stage III or IV melanoma', 'patients with advanced melanoma who started metastatic treatment with']","['ipilimumab monotherapy', 'ipilimumab']","['OS', 'median OS', 'Overall survival', 'sustained long-term survival', 'median OS of patients with asymptomatic brain metastasis', 'overall survival (OS', 'incidence of grade 3/4 treatment-related AEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1367202', 'cui_str': 'ipilimumab'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.585321,"In patients with wild-type or mutant  BRAF  tumors, median OS was 13.8 months (95% CI 10.2 to 17.0) and 33.2 months (95% CI 19.4 to 45.2) in the 10 mg/kg group, and 11.2 months (95% CI 9.2 to 13.8) and 19.7 months (95% CI 11.6 to 25.3) in the 3 mg/kg group, respectively.","[{'ForeName': 'Paolo Antonio', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Melanoma, Cancer Immunotherapy and Innovative Therapy Unit, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy paolo.ascierto@gmail.com.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Del Vecchio', 'Affiliation': 'Unit of Melanoma Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, Italy.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Mackiewicz', 'Affiliation': 'Department of Diagnostics and Cancer Immunology, Greater Poland Cancer Center, Poznan Medical University, Poznan, Poland.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Department of Medicine, Dermatology Service, Gustave Roussy, Villejuif and Paris-Sud-University, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Vanna', 'Initials': 'V', 'LastName': 'Chiarion-Sileni', 'Affiliation': 'Melanoma Oncology Unit, Istituto Oncologico Veneto-IRCCS, Padova, Italy.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Arance', 'Affiliation': ""Hospital Clinic and Institut D'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.""}, {'ForeName': 'Céleste', 'Initials': 'C', 'LastName': 'Lebbé', 'Affiliation': 'Université de Paris, INSERM, Dermatology and CIC, Saint Louis Hospital, Paris, France.'}, {'ForeName': 'Inge Marie', 'Initials': 'IM', 'LastName': 'Svane', 'Affiliation': 'Center for Cancer Immune Therapy, Herlev Hospital, Herlev, Denmark.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'McNeil', 'Affiliation': ""Chris O'Brien Lifehouse and Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.""}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Skłodowska-Curie Institute-Oncology Center, Warsaw, Poland.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Loquai', 'Affiliation': 'Department of Dermatology, University Medical Center, Mainz, Germany.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Mortier', 'Affiliation': ""Clinique de Dermatologie, Unité d'Onco-Dermatologie, INSERM U1189, Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez, Lille, France.""}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Hamid', 'Affiliation': 'Melanoma Center, The Angeles Clinic and Research Institute, Los Angeles, California, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bastholt', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Dreno', 'Affiliation': 'Department of Oncodermatology, University Hospital Centre Nantes, Nantes, Pays de la Loire, France.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Garbe', 'Affiliation': 'Department of Dermatology, Eberhard Karls Universitat Tübingen, Tübingen, Baden-Württemberg, Germany.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Nyakas', 'Affiliation': 'Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Dermatology and Skin Cancers Department, Aix-Marseille University, APHM, Marseille, France.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Thomas', 'Affiliation': 'Department of Dermatology, Centre Hospitalier Lyon-Sud, Pierre-Bénite, France.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Liszkay', 'Affiliation': 'Department of Oncodermatology, National Institute of Oncology, Budapest, Hungary.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Smylie', 'Affiliation': 'Department of Oncology, Cross Cancer Institute, Edmonton, Alberta, Canada.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Hoeller', 'Affiliation': 'Division of General Dermatology and Dermato-Oncology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Ferraresi', 'Affiliation': 'Unit of Medical Oncology, IRCCS-Regina Elena National Cancer Institute, Rome, Italy.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Grange', 'Affiliation': 'Department of Dermatology, University Hospital Centre Reims, Reims, Champagne-Ardenne, France.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Gutzmer', 'Affiliation': 'Operative Dermatology and Dermato-Oncology, Medizinische Hochschule Hannover, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Pikiel', 'Affiliation': 'Department of Oncology, Wojewodzkie Centrum Oncologii, Gdańsk, Poland.'}, {'ForeName': 'Fareeda', 'Initials': 'F', 'LastName': 'Hosein', 'Affiliation': 'Oncology Clinical Development, Bristol-Myers Squibb Co, Princeton, New Jersey, USA.'}, {'ForeName': 'Burcin', 'Initials': 'B', 'LastName': 'Simsek', 'Affiliation': 'Oncology Clinical Development, Bristol-Myers Squibb Co, Princeton, New Jersey, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Maio', 'Affiliation': 'Center for Immuno-Oncology, University Hospital of Siena, Instituto Toscano Tumori, Siena, Italy.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2019-000391']
1978,32503948,Early tumor shrinkage identifies long-term disease control and survival in patients with lung cancer treated with atezolizumab.,"BACKGROUND


Preliminary evidence indicates that early tumor shrinkage (ETS) following immune checkpoint inhibitor (ICI) initiation may be associated with survival outcomes in patients with advanced melanoma. ETS has not been explored as a biomarker of survival outcomes or patient-reported outcomes in patients with advanced non-small cell lung cancer (NSCLC) treated with ICIs.
METHODS


The study pooled data from patients with NSCLC in the randomized trials OAK and POPLAR (atezolizumab vs docetaxel; n=1464), and single-arm atezolizumab trials BIRCH and FIR (n=797). The association between ETS (≥10% decrease in pretreatment sum-of-longest diameters of target-lesions at 6 weeks) and overall survival (OS), progression-free survival (PFS), time to deterioration (TDD) in health-related quality-of-life (HRQoL) and physical function (PF) was assessed using Cox proportional hazard analysis.
RESULTS


ETS occurred in 20% of atezolizumab-treated patients with NSCLC within OAK and POPLAR and was associated with highly favorable OS (HR 0.33, p<0.001), PFS (HR 0.31, p<0.001), TDD in HRQoL (HR 0.73, p=0.01) and PF (HR 0.52, p<0.001). The results were replicated in the BIRCH and FIR data. Atezolizumab-treated patients achieving ETS had markedly improved OS compared with docetaxel-treated patients achieving ETS (24-month OS 55% vs 32%); PFS was also markedly improved (24-month PFS 31% vs 4%). In contrast, for patients not achieving ETS, atezolizumab-treatment was associated with more modest OS (24-month OS 23% vs 20%) and PFS (24-month PFS 3% vs 1%) improvement compared with docetaxel. Overall, the effect size for ETS within the atezolizumab-treated patients was significantly greater than that in the docetaxel-treated patients (P(interaction)=0.002 for OS and P(interaction)<0.001 for PFS).
CONCLUSIONS


ETS is an easily measurable biomarker, predictive of highly favorable survival and patient-reported outcomes with atezolizumab treatment for advanced NSCLC. Further, ETS identifies patients with significantly greater treatment benefit for ICI therapy.",2020,"Overall, the effect size for ETS within the atezolizumab-treated patients was significantly greater than that in the docetaxel-treated patients (P(interaction)=0.002 for OS and P(interaction)<0.001 for PFS).
","['patients with advanced melanoma', 'patients with advanced non-small cell lung cancer (NSCLC) treated with ICIs', 'patients with lung cancer treated with', 'patients with NSCLC']","['atezolizumab', 'POPLAR (atezolizumab vs docetaxel', 'docetaxel', 'Atezolizumab-treated patients achieving ETS']","['modest OS', 'PFS', 'OS', 'effect size for ETS', 'overall survival (OS), progression-free survival (PFS), time to deterioration (TDD) in health-related quality-of-life (HRQoL) and physical function (PF', 'TDD in HRQoL', 'survival outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0522458', 'cui_str': 'Populus'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0183841', 'cui_str': 'TDD'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.160724,"Overall, the effect size for ETS within the atezolizumab-treated patients was significantly greater than that in the docetaxel-treated patients (P(interaction)=0.002 for OS and P(interaction)<0.001 for PFS).
","[{'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Hopkins', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia ashley.hopkins@flinders.edu.au.'}, {'ForeName': 'Ganessan', 'Initials': 'G', 'LastName': 'Kichenadasse', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Chris S', 'Initials': 'CS', 'LastName': 'Karapetis', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Rowland', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Sorich', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2019-000500']
1979,32494772,"Randomized trial to evaluate contraceptive efficacy, safety and acceptability of a two-rod contraceptive implant over 4 years in the Dominican Republic.","Objective


Sino-implant (II) is a contraceptive implant that had a commodity price one-third of the competing products a decade ago. To make Sino-implant (II) more widely available, we conducted a trial to collect safety and efficacy data required for World Health Organization (WHO) prequalification, a quality standard allowing global donors to procure a pharmaceutical product.
Study design


This was a randomized controlled trial allocating 650 participants to either Sino-implant (II) or Jadelle®. Participants were seen at 1 and 6 months, and then semiannually. The primary efficacy measure was the pregnancy Pearl Index [number of pregnancies per 100 women-years (WY) of follow-up] in the Sino-implant (II) group during up to 4 years of implant use.
Results


For the primary outcome, Sino-implant (II) had a 4-year Pearl Index of 0.74 (95% confidence interval, 0.36-1.37) compared to 0.00 (95% confidence interval, 0.00-1.04) for Jadelle®. The Sino-implant (II) pregnancy rate was significantly higher in the fourth year (3.54 per 100 WY) than in the first 3 years combined (0.18 per 100 WY; p <.001). Total levonorgestrel concentrations were equivalent between groups at month 12, but were 19%, 22% and 32% lower in the Sino-implant (II) group at months 24, 36 and 48, respectively (p <.001 at each time point). Safety and acceptability of the two products were similar, while providers documented significantly higher breakage rates during removal of Sino-implant (II) (16.3% vs. 3.1%; p <.001).
Conclusion


Based on these results, WHO prequalified Sino-Implant (II) with a 3-year use label in June 2017, 2 years shorter than the 5-year duration of Jadelle®.
Implications


WHO prequalification allows global donors to procure Sino-implant (II), which means women in many low resource countries will have greater access to highly effective and acceptable contraceptive implants. Our study noted important clinical differences, including shorter duration of high effectiveness with Sino-implant (II) when compared to the other available two-rod system, Jadelle®. Introduction strategies should include appropriate training on these differences.",2019,"Safety and acceptability of the two products were similar, while providers documented significantly higher breakage rates during removal of Sino-implant (II) (16.3% vs. 3.1%; p <.001).
",['650 participants to either Sino-implant (II) or Jadelle®'],"['Objective\n\n\nSino-implant (II', 'two-rod contraceptive implant']","['Sino-implant (II) had a 4-year Pearl Index', 'Sino-implant (II) pregnancy rate', 'Total levonorgestrel concentrations', 'contraceptive efficacy, safety and acceptability', 'breakage rates', 'Safety and acceptability', 'pregnancy Pearl Index']","[{'cui': 'C3844101', 'cui_str': '650'}, {'cui': 'C0064022', 'cui_str': 'isononanoyl oxybenzene sulfonate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0064022', 'cui_str': 'isononanoyl oxybenzene sulfonate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0035086', 'cui_str': 'Renal osteodystrophy'}, {'cui': 'C1657106', 'cui_str': 'Contraceptive implant'}]","[{'cui': 'C0064022', 'cui_str': 'isononanoyl oxybenzene sulfonate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]",650.0,0.108083,"Safety and acceptability of the two products were similar, while providers documented significantly higher breakage rates during removal of Sino-implant (II) (16.3% vs. 3.1%; p <.001).
","[{'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Steiner', 'Affiliation': 'Contraceptive Technology Innovation Division, FHI 360, 359 Blackwell Street, Durham, NC 27701, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Brache', 'Affiliation': 'Asociación Dominicana Pro Bienestar de la Familia, Inc. (PROFAMILIA), Santo Domingo, Dominican Republic.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Taylor', 'Affiliation': 'Contraceptive Technology Innovation Division, FHI 360, 359 Blackwell Street, Durham, NC 27701, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Callahan', 'Affiliation': 'Contraceptive Technology Innovation Division, FHI 360, 359 Blackwell Street, Durham, NC 27701, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Halpern', 'Affiliation': 'Contraceptive Technology Innovation Division, FHI 360, 359 Blackwell Street, Durham, NC 27701, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Jorge', 'Affiliation': 'Asociación Dominicana Pro Bienestar de la Familia, Inc. (PROFAMILIA), Santo Domingo, Dominican Republic.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wevill', 'Affiliation': 'Contraceptive Technology Innovation Division, FHI 360, 359 Blackwell Street, Durham, NC 27701, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sergison', 'Affiliation': 'Contraceptive Technology Innovation Division, FHI 360, 359 Blackwell Street, Durham, NC 27701, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Venkatasubramanian', 'Affiliation': 'Contraceptive Technology Innovation Division, FHI 360, 359 Blackwell Street, Durham, NC 27701, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Dorflinger', 'Affiliation': 'Contraceptive Technology Innovation Division, FHI 360, 359 Blackwell Street, Durham, NC 27701, USA.'}]",Contraception: X,['10.1016/j.conx.2019.100006']
1980,32499064,Serostatus cutoff levels and fold increase to define seroresponse to recombinant vesicular stomatitis virus - Zaire Ebola virus envelope glycoprotein vaccine: An evidence-based analysis.,"The recombinant vesicular stomatitis virus - Zaire Ebola virus envelope glycoprotein (rVSVΔG-ZEBOV-GP) vaccine is a live recombinant vesicular stomatitis virus (VSV) where the VSV G protein is replaced with ZEBOV-GP. To better understand the immune response after receiving the rVSVΔG-ZEBOV-GP vaccine, the current analyses evaluated different definitions of seroresponse that differentiate vaccine and placebo recipients enrolled in a placebo-controlled clinical trial (PREVAIL; NCT02344407) in which a subset of the study participants had elevated baseline titers. Alternative values for serostatus cutoff (SSCO; 200-500 EU/mL) and/or fold rise (two- to five-fold) were applied to compare their ability to distinguish between participants receiving rVSVΔG-ZEBOV-GP or placebo. The results indicate that an SSCO of 200 EU/mL can be used to define seropositivity at baseline (i.e. pre-vaccination). The use of dual criteria of the same SSCO (200 EU/mL) together with a two-fold rise in antibody level from baseline provided the definition of seroresponse that maximized the statistical significance between vaccine recipients and placebo recipients post-vaccination. Clinical trial registration: NCT02344407.",2020,The recombinant vesicular stomatitis virus - Zaire Ebola virus envelope glycoprotein,[],"['rVSVΔG-ZEBOV-GP or placebo', 'glycoprotein vaccine', 'rVSVΔG-ZEBOV-GP vaccine', 'rVSVΔG-ZEBOV-GP) vaccine', 'recombinant vesicular stomatitis virus - Zaire Ebola virus envelope glycoprotein', 'placebo']",[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017968', 'cui_str': 'Glycoprotein'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0042587', 'cui_str': 'Vesicular stomatitis Indiana virus'}, {'cui': 'C0949896', 'cui_str': 'Zaire virus'}]",[],,0.221722,The recombinant vesicular stomatitis virus - Zaire Ebola virus envelope glycoprotein,"[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Antonello', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA. Electronic address: joseph_antonello@merck.com.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Grant-Klein', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA. Electronic address: rebecca.klein1@merck.com.'}, {'ForeName': 'Rick', 'Initials': 'R', 'LastName': 'Nichols', 'Affiliation': 'Crozet BioPharma LLC., Devens, MA, USA. Electronic address: rick.nichols@crozetbiopharma.com.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Kennedy', 'Affiliation': 'Partnership for Research on Ebola Virus in Liberia (PREVAIL), Monrovia, Liberia. Electronic address: sbkennedy4@aol.com.'}, {'ForeName': 'Sheri', 'Initials': 'S', 'LastName': 'Dubey', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA. Electronic address: sheri_dubey@merck.com.'}, {'ForeName': 'Jakub K', 'Initials': 'JK', 'LastName': 'Simon', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA. Electronic address: jakub.simon@merck.com.'}]",Vaccine,['10.1016/j.vaccine.2020.04.061']
1981,32496886,Influence of virtual keyboard design and usage posture on typing performance and muscle activity during tablet interaction.,"This study aimed to determine the effects of virtual keyboard designs and postures on task performance and muscle activity during tablet use. Eighteen healthy adults were randomly assigned to one of three postures (DESK, LAP, BED) to complete six sessions of 60-minute typing on a tablet with three virtual keyboards (STD, WIDE, SPLIT) twice in an experimental laboratory. Keystroke dynamics and muscle activity of the forearm and neck-shoulder regions were measured by electromyography. The split virtual keyboard was found to be associated with faster typing speed (SPLIT vs STD,  p  = .015; SPLIT vs WIDE,  p  < .001) and decreased muscle activity of extensor digitorum communis (SPLIT vs STD,  p  = .021). Lap posture was associated with faster typing speed ( p  = .018) and higher forearm muscle activity ( p  < .05). Typing performance decreased ( p  < .001) with elevated neck extensor muscle activity ( p  = .042) when the task duration prolonged. The split virtual keyboard showed potential to improve tablet ergonomics under various postures.  Practitioner Summary:  Tablets have become widely used for a variety of tasks and have gradually expanded into the realm of mobile productivity and education. Adequate designs of virtual keyboards for tablets show the potential for increased task performance and decreased muscle activity pertinent to typing activity and posture constraints imposed by non-traditional work positions.  Abbreviations:  WPM: words per minute; IKI: inter-key press interval; EMG: electromyography; EDC: extensor digitorum communis; FDS: flexor digitorum superficialis; CES: cervical erector spinae; UT: upper trapezius; EA: electrical activity; MVC: maximum voluntary contraction; APDF: amplitude probability distribution function.",2020,"The split virtual keyboard was found to be associated with faster typing speed (SPLIT vs STD, p = 0.015; SPLIT vs WIDE, p < 0.001) and decreased muscle activity of extensor digitorum communis (SPLIT vs STD, p = 0.021).",['Eighteen healthy adults'],"['virtual keyboard design and usage posture', 'virtual keyboard designs and postures']","['Typing performance', 'elevated neck extensor muscle activity', 'muscle activity of extensor digitorum communis', 'task performance and muscle activity', 'Keystroke dynamics and muscle activity of the forearm and neck-shoulder regions', 'forearm muscle activity']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}]","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0224268', 'cui_str': 'Structure of extensor digitorum muscle of hand'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C1760774', 'cui_str': 'Structure of muscle of forearm'}]",18.0,0.0249073,"The split virtual keyboard was found to be associated with faster typing speed (SPLIT vs STD, p = 0.015; SPLIT vs WIDE, p < 0.001) and decreased muscle activity of extensor digitorum communis (SPLIT vs STD, p = 0.021).","[{'ForeName': 'Ming-I Brandon', 'Initials': 'MB', 'LastName': 'Lin', 'Affiliation': 'Department of Industrial and Information Management, National Cheng-Kung University, Tainan, Taiwan.'}, {'ForeName': 'Ruei-Hong', 'Initials': 'RH', 'LastName': 'Hong', 'Affiliation': 'Institute of Information Management, National Cheng-Kung University, Tainan, Taiwan.'}, {'ForeName': 'Yu-Ping', 'Initials': 'YP', 'LastName': 'Huang', 'Affiliation': 'Department of Industrial and Information Management, National Cheng-Kung University, Tainan, Taiwan.'}]",Ergonomics,['10.1080/00140139.2020.1778097']
1982,32497783,Study protocol: Using peer support to aid in prevention and treatment in prediabetes (UPSTART).,"BACKGROUND


There is an urgent need to develop and evaluate effective and scalable interventions to prevent or delay the onset of type 2 diabetes mellitus (T2DM).
METHODS


In this randomized controlled pragmatic trial, 296 adults with prediabetes will be randomized to either a peer support arm or enhanced usual care. Participants in the peer support arm meet face-to-face initially with a trained peer coach who also is a patient at the same health center to receive information on locally available wellness and diabetes prevention programs, discuss behavioral goals related to diabetes prevention, and develop an action plan for the next week to meet their goals. Over six months, peer coaches call their assigned participants weekly to provide support for weekly action steps. In the final 6 months, coaches call participants at least once monthly. Participants in the enhanced usual care arm receive information on local resources and periodic updates on available diabetes prevention programs and resources. Changes in A1c, weight, waist circumference and other patient-centered outcomes and mediators and moderators of intervention effects will be assessed.
RESULTS


At least 296 participants and approximately 75 peer supporters will be enrolled.
DISCUSSION


Despite evidence that healthy lifestyle interventions can improve health behaviors and reduce risk for T2DM, engagement in recommended behavior change is low. This is especially true among racial and ethnic minority and low-income adults. Regular outreach and ongoing support from a peer coach may help participants to initiate and sustain healthy behavior changes to reduce their risk of diabetes.
TRIAL REGISTRATION


The ClinicalTrials.gov registration number is NCT03689530.",2020,"Changes in A1c, weight, waist circumference and other patient-centered outcomes and mediators and moderators of intervention effects will be assessed.
","['296 adults with prediabetes', 'At least 296 participants and approximately 75 peer supporters will be enrolled']","['peer support arm or enhanced usual care', 'peer support arm meet face-to-face initially with a trained peer coach who also is a patient at the same health center to receive information on locally available wellness and diabetes prevention programs, discuss behavioral goals related to diabetes prevention, and develop an action plan']","['Changes in A1c, weight, waist circumference', 'health behaviors']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1273866', 'cui_str': 'Action plan (community)'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",296.0,0.0609549,"Changes in A1c, weight, waist circumference and other patient-centered outcomes and mediators and moderators of intervention effects will be assessed.
","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Heisler', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America; VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, United States of America. Electronic address: mheisler@umich.edu.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Kullgren', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America; VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, United States of America; Department of Health Management and Policy, University of Michigan School of Public Health, Ann Arbor, MI, United States of America; University of Michigan Institute for Healthcare Policy and Innovation, Ann Arbor, MI, United States of America. Electronic address: jkullgre@med.umich.edu.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Richardson', 'Affiliation': 'Department of Family Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America. Electronic address: caroli@umich.edu.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Stoll', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America. Electronic address: scstoll@umich.edu.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Alvarado Nieves', 'Affiliation': 'University of Michigan, Department of Internal Medicine- Metabolism, Endocrinology and Diabetes, United States of America. Electronic address: alvaradc@med.umich.edu.'}, {'ForeName': 'Deanne', 'Initials': 'D', 'LastName': 'Wiley', 'Affiliation': 'Kaiser Permanente Northern California, United States of America. Electronic address: deanne.wiley@kp.org.'}, {'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Sedgwick', 'Affiliation': 'Kaiser Permanente Northern California Division of Research, United States of America. Electronic address: Tali.S.Sedgwick@kp.org.'}, {'ForeName': 'Alyce', 'Initials': 'A', 'LastName': 'Adams', 'Affiliation': 'Kaiser Permanente Northern California, United States of America. Electronic address: Alyce.S.Adams@kp.org.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Hedderson', 'Affiliation': 'Kaiser Permanente Northern California, United States of America. Electronic address: Monique.m.hedderson@kp.org.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'The Permanente Medical Group (Kaiser Permanente, Northern California), United States of America. Electronic address: Eileen.Kim@kp.org.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Rao', 'Affiliation': 'The Permanente Medical Group (Kaiser Permanente, Northern California), United States of America. Electronic address: megan.rao@kp.org.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Schmittdiel', 'Affiliation': 'Kaiser Permanente Northern California Division of Research, United States of America. Electronic address: Julie.A.Schmittdiel@kp.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106048']
1983,32497906,Radial versus femoral artery access for percutaneous coronary artery intervention in patients with acute myocardial infarction and multivessel disease complicated by cardiogenic shock: Subanalysis from the CULPRIT-SHOCK trial.,"BACKGROUND


The use and impact of transradial artery access (TRA) compared to transfemoral artery access (TFA) in patients undergoing percutaneous coronary intervention (PCI) for acute myocardial infarction (MI) complicated by cardiogenic shock (CS) remain unclear.
METHODS


This is a post hoc analysis of the CULPRIT-SHOCK trial where patients presenting with MI and multivessel disease complicated by CS were randomized to a strategy of culprit-lesion-only or immediate multivessel PCI. Arterial access was left at operator's discretion. Adjudicated outcomes of interest were the composite of death or renal replacement therapy (RRT) at 30 days and 1 year. Multivariate logistic models were used to assess the association between the arterial access and outcomes.
RESULTS


Among the 673 analyzed patients, TRA and TFA were successfully performed in 118 (17.5%) and 555 (82.5%) patients, respectively. Compared to TFA, TRA was associated with a lower 30-day rate of death or RRT (37.3% vs 53.2%, adjusted odds ratio [aOR]: 0.57; 95% confidence interval [CI] 0.34-0.96), a lower 30-day rate of death (34.7% vs 49.7%; aOR: 0.56; 95% CI 0.33-0.96), and a lower 30-day rate of RRT (5.9% vs 15.9%; aOR: 0.40; 95% CI 0.16-0.97). No significant differences were observed regarding the 30-day risks of type 3 or 5 Bleeding Academic Research Consortium bleeding and stroke. The observed reduction of death or RRT and death with TRA was no longer significant at 1 year (44.9% vs 57.8%; aOR: 0.85; 95% CI 0.50-1.45 and 42.4% vs 55.5%, aOR: 0.78; 95% CI 0.46-1.32, respectively).
CONCLUSIONS


In patients undergoing PCI for acute MI complicated by CS, TRA may be associated with improved early outcomes, although the reason for this finding needs further research.",2020,No significant differences were observed regarding the 30-day risks of type 3 or 5 Bleeding Academic Research Consortium bleeding and stroke.,"['patients with acute myocardial infarction and multivessel disease complicated by cardiogenic shock', 'patients undergoing', 'patients presenting with MI and multivessel disease complicated by CS']","['Radial versus femoral artery access', 'percutaneous coronary intervention (PCI', 'transradial artery access (TRA', 'percutaneous coronary artery intervention', 'transfemoral artery access (TFA']","['TRA and TFA', '30-day rate of death', '30-day rate of RRT', '30-day risks of type 3 or 5 Bleeding Academic Research Consortium bleeding and stroke', 'death or RRT and death with TRA', '30-day rate of death or RRT', 'composite of death or renal replacement therapy (RRT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",673.0,0.38324,No significant differences were observed regarding the 30-day risks of type 3 or 5 Bleeding Academic Research Consortium bleeding and stroke.,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Guedeney', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Kerneis', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Barthélémy', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Baumann', 'Affiliation': 'First Department of Medicine-Cardiology, University Medical Centre Mannheim (UMM), University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Sandri', 'Affiliation': 'Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'de Waha-Thiele', 'Affiliation': 'Medical Clinic II, University Heart Center Lübeck, Lübeck, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Fuernau', 'Affiliation': 'Medical Clinic II, University Heart Center Lübeck, Lübeck, Germany.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Rouanet', 'Affiliation': 'Statistician unit, StatEthic, Levallois-Perret, France.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Piek', 'Affiliation': 'Department of Clinical and Experimental Cardiology, Amsterdam University Medical Centers, Academic Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Landmesser', 'Affiliation': 'Universitätsklinikum Charité, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hauguel-Moreau', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Zeitouni', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France.'}, {'ForeName': 'Johanne', 'Initials': 'J', 'LastName': 'Silvain', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Lattuca', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Inselspital Bern, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Collet', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Desch', 'Affiliation': 'Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Zeymer', 'Affiliation': 'Institut für Herzinfarktforschung and Klinikum Ludwigshafen, Ludwigshafen, Germany.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France. Electronic address: gilles.montalescot@aphp.fr.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Akin', 'Affiliation': 'First Department of Medicine-Cardiology, University Medical Centre Mannheim (UMM), University of Heidelberg, Mannheim, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.04.014']
1984,32497927,Influence of type 1 diabetes on the postural control of women in the third gestational trimester.,"BACKGROUND


Diabetes can cause biomechanical alterations that may be responsible for additional changes to those existing in a regular gestational period. The way a maternal body responds when affected by diabetes has not been clearly understood. This study aimed to describe the influence of type 1 diabetes on pregnant women's postural control.
METHODS


Forty pregnant women in their third gestational trimester were allocated in two equal groups - the control group and the type 1 diabetic group. The variables related to postural control and balance were assessed using photogrammetry (head protrusion; cervical lordosis; thoracic kyphosis; lumbar lordosis; pelvic anteversion, knee flexion, tibiotarsal and foot inclination angles were measured), and baropodometry (anteroposterior and mediolateral distance trajectory of the center of pressure, amplitude and average speed of displacement of the center of pressure).
FINDINGS


The results of the type 1 diabetic group showed, in the postural analysis, lower head protrusion and pelvic anteversion angles, while there was higher cervical lordosis, thoracic kyphosis, and lumbar lordosis angles. In the baropodometry, the anteroposterior distance and the amplitude of the center of pressure displacement with eyes open and closed were higher.
INTERPRETATION


The findings suggest that type 1 diabetes mellitus in the third trimester of pregnancy is associated with postural changes, a decrease in the active ankle range of motion and increase in the anteroposterior oscillation of the center of pressure, with negative repercussions for postural control.",2020,"The results of the type 1 diabetic group showed, in the postural analysis, lower head protrusion and pelvic anteversion angles, while there was higher cervical lordosis, thoracic kyphosis, and lumbar lordosis angles.","['Forty pregnant women in their third gestational trimester', 'women in the third gestational trimester', ""pregnant women's postural control""]",[],"['postural analysis, lower head protrusion and pelvic anteversion angles', 'postural control and balance were assessed using photogrammetry (head protrusion; cervical lordosis; thoracic kyphosis; lumbar lordosis; pelvic anteversion, knee flexion, tibiotarsal and foot inclination angles were measured), and baropodometry (anteroposterior and mediolateral distance trajectory of the center of pressure, amplitude and average speed of displacement of the center of pressure', 'cervical lordosis, thoracic kyphosis, and lumbar lordosis angles']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0032982', 'cui_str': 'Trimesters'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}]",[],"[{'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0333056', 'cui_str': 'Protrusion'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0333053', 'cui_str': 'Anteversion'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0031747', 'cui_str': 'Photogrammetry'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0024003', 'cui_str': 'Lordosis accentuated'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0022821', 'cui_str': 'Kyphosis deformity of spine'}, {'cui': 'C1184923', 'cui_str': 'Lumbar hyperlordosis'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}]",40.0,0.0325439,"The results of the type 1 diabetic group showed, in the postural analysis, lower head protrusion and pelvic anteversion angles, while there was higher cervical lordosis, thoracic kyphosis, and lumbar lordosis angles.","[{'ForeName': 'Paola Marini', 'Initials': 'PM', 'LastName': 'Valerio', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes, 3900, Ribeirão Preto, São Paulo CEP: 14049-900, Brazil. Electronic address: paola.marini@usp.br.'}, {'ForeName': 'Vanessa Ellen', 'Initials': 'VE', 'LastName': 'Gonçalves', 'Affiliation': 'Physical Therapy Course, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes, 3900, Ribeirão Preto, São Paulo CEP: 14049-900, Brazil. Electronic address: vanessa.ellen.goncalves@usp.br.'}, {'ForeName': 'Catarina Clapis', 'Initials': 'CC', 'LastName': 'Zordão', 'Affiliation': 'Physical Therapy Course, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes, 3900, Ribeirão Preto, São Paulo CEP: 14049-900, Brazil. Electronic address: catarina.zordao@usp.br.'}, {'ForeName': 'Monique Silva', 'Initials': 'MS', 'LastName': 'Rezende', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes, 3900, Ribeirão Preto, São Paulo CEP: 14049-900, Brazil. Electronic address: moniquerezende@usp.br.'}, {'ForeName': 'Elaine Christine Dantas', 'Initials': 'ECD', 'LastName': 'Moisés', 'Affiliation': 'Postgraduate Program in Gynecology and Obstetrics, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes, 3900, Ribeirão Preto, São Paulo CEP: 14049-900, Brazil. Electronic address: elainemoises@fmrp.usp.br.'}, {'ForeName': 'Elaine Caldeira de Olveira', 'Initials': 'ECO', 'LastName': 'Guirro', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes, 3900, Ribeirão Preto, São Paulo CEP: 14049-900, Brazil. Electronic address: ecguirro@fmrp.usp.br.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105062']
1985,32510169,A study on clinical effect of Arbidol combined with adjuvant therapy on COVID-19.,"This study aims to explore the clinical effect of Arbidol (ARB) combined with adjuvant therapy on patients with coronavirus disease 2019 (COVID-19). The study included 62 patients with COVID-19 admitted to the First Hospital of Jiaxing from January to March 2020, and all patients were divided into the test group and the control group according to whether they received ARB during hospitalization. Various indexes in the two groups before and after treatment were observed and recorded, including fever, cough, hypodynamia, nasal obstruction, nasal discharge, diarrhea, C-reactive protein (CRP), procalcitonin (PCT), blood routine indexes, blood biochemical indexes, time to achieve negative virus nucleic acid, and so on. The fever and cough in the test group were relieved markedly faster than those in the control group (P  <  .05); there was no obvious difference between the two groups concerning the percentage of patients with abnormal CRP, PCT, blood routine indexes, aspartate aminotransferase, and alanine aminotransferase (P > .05); the time for two consecutive negative nucleic acid tests in the test group were shorter than that in the control group; the hospitalization period of the patients in the test group and control group were (16.5  ±  7.14) days and (18.55  ±  7.52) days, respectively. ARB combined with adjuvant therapy might be able to relieve the fever of COVID-19 sufferers faster and accelerate the cure time to some degree, hence it's recommended for further research clinically.",2020,"The fever and cough in the test group were relieved markedly faster than those in the control group (p<0.05); there was no obvious difference between the two groups concerning the percentage of patients with abnormal CRP, PCT, blood routine indexes, aspartate aminotransferase and alanine aminotransferase (p>0.05); the time for two consecutive negative nucleic acid tests in the test group were shorter than that in the control group; the hospitalization period of the patients in the test group and control group were (16.5 ± 7.14) d and (18.55 ± 7.52) d, respectively.
","['patients with coronavirus disease 2019 (COVID-19', '62 patients with COVID-19 admitted to the First Hospital of Jiaxing from January to March, 2020, and all patients']","['Arbidol (ARB) combined with adjuvant therapy', 'ARB combined with adjuvant therapy', 'Arbidol combined with adjuvant therapy']","['fever, cough, hypodynamia, nasal obstruction, nasal discharge, diarrhea, C-reactive protein (CRP), procalcitonin (PCT), blood routine indexes, blood biochemical indexes, time to achieve negative virus nucleic acid and so on', 'abnormal CRP, PCT, blood routine indexes, aspartate aminotransferase and alanine aminotransferase (p>0.05); the time for two consecutive negative nucleic acid tests', 'fever and cough']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0254211', 'cui_str': 'umifenovir'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0242684', 'cui_str': 'Hypodynamia'}, {'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",62.0,0.0182083,"The fever and cough in the test group were relieved markedly faster than those in the control group (p<0.05); there was no obvious difference between the two groups concerning the percentage of patients with abnormal CRP, PCT, blood routine indexes, aspartate aminotransferase and alanine aminotransferase (p>0.05); the time for two consecutive negative nucleic acid tests in the test group were shorter than that in the control group; the hospitalization period of the patients in the test group and control group were (16.5 ± 7.14) d and (18.55 ± 7.52) d, respectively.
","[{'ForeName': 'Wenyu', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Respiration, Affiliated Hospital of Jiaxing University/The First Hospital of Jiaxing, Jiaxing, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Yao', 'Affiliation': 'Center for Pain Medicine, Affiliated Hospital of Jiaxing University/The First Hospital of Jiaxing, Jiaxing, China.'}, {'ForeName': 'Zhixian', 'Initials': 'Z', 'LastName': 'Fang', 'Affiliation': 'Department of Respiration, Affiliated Hospital of Jiaxing University/The First Hospital of Jiaxing, Jiaxing, China.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Lv', 'Affiliation': 'Department of Respiration, Affiliated Hospital of Jiaxing University/The First Hospital of Jiaxing, Jiaxing, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Deng', 'Affiliation': 'Department of Infectious Disease, Affiliated Hospital of Jiaxing University/The First Hospital of Jiaxing, Jiaxing, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Orthopedics, Tongde Hospital of Zhejiang Province, Hangzhou, China.'}]",Journal of medical virology,['10.1002/jmv.26142']
1986,32511226,"Safety and efficacy of co-administered diethylcarbamazine, albendazole and ivermectin during mass drug administration for lymphatic filariasis in Haiti: Results from a two-armed, open-label, cluster-randomized, community study.","In Haiti, 22 communes still require mass drug administration (MDA) to eliminate lymphatic filariasis (LF) as a public health problem. Several clinical trials have shown that a single oral dose of ivermectin (IVM), diethylcarbamazine (DEC) and albendazole (ALB) (IDA) is more effective than DEC plus ALB (DA) for clearing Wuchereria bancrofti microfilariae (Mf). We performed a cluster-randomized community study to compare the safety and efficacy of IDA and DA in an LF-endemic area in northern Haiti. Ten localities were randomized to receive either DA or IDA. Participants were monitored for adverse events (AE), parasite antigenemia, and microfilaremia. Antigen-positive participants were retested one year after MDA to assess treatment efficacy. Fewer participants (11.0%, 321/2917) experienced at least one AE after IDA compared to DA (17.3%, 491/2844, P<0.001). Most AEs were mild, and the three most common AEs reported were headaches, dizziness and abdominal pain. Serious AEs developed in three participants who received DA. Baseline prevalence for filarial antigenemia was 8.0% (239/3004) in IDA localities and 11.5% (344/2994) in DA localities (<0.001). Of those with positive antigenemia, 17.6% (42/239) in IDA localities and 20.9% (72/344, P = 0.25) in DA localities were microfilaremic. One year after treatment, 84% percent of persons with positive filarial antigen tests at baseline could be retested. Clearance rates for filarial antigenemia were 20.5% (41/200) after IDA versus 25.4% (74/289) after DA (P = 0.3). However, 94.4% (34/36) of IDA recipients and 75.9% (44/58) of DA recipients with baseline microfilaremia were Mf negative at the time of retest (P = 0.02). Thus, MDA with IDA was at least as well tolerated and significantly more effective for clearing Mf compared to the standard DA regimen in this study. Effective MDA coverage with IDA could accelerate the elimination of LF as a public health problem in the 22 communes that still require MDA in Haiti.",2020,Baseline prevalence for filarial antigenemia was 8.0% (239/3004) in IDA localities and 11.5% (344/2994) in DA localities (<0.001).,"['lymphatic filariasis in Haiti', 'LF-endemic area in northern Haiti']","['IDA and DA', 'ivermectin (IVM), diethylcarbamazine (DEC) and albendazole (ALB) (IDA', 'DA or IDA', 'diethylcarbamazine, albendazole and ivermectin', 'DEC plus ALB (DA']","['Clearance rates for filarial antigenemia', 'filarial antigenemia', 'Safety and efficacy', 'headaches, dizziness and abdominal pain', 'adverse events (AE), parasite antigenemia, and microfilaremia']","[{'cui': 'C0013884', 'cui_str': 'Lymphatic filariasis'}, {'cui': 'C0018510', 'cui_str': 'Haiti'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0001909', 'cui_str': 'Albania'}, {'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C0012191', 'cui_str': 'Diethylcarbamazine'}, {'cui': 'C0001911', 'cui_str': 'Albendazole'}]","[{'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C1621857', 'cui_str': 'Filarial worm'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}]",10.0,0.218718,Baseline prevalence for filarial antigenemia was 8.0% (239/3004) in IDA localities and 11.5% (344/2994) in DA localities (<0.001).,"[{'ForeName': 'Christine L', 'Initials': 'CL', 'LastName': 'Dubray', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Anita D', 'Initials': 'AD', 'LastName': 'Sircar', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Valery Madsen', 'Initials': 'VM', 'LastName': 'Beau de Rochars', 'Affiliation': 'University of Florida, Gainsville, Florida, United States of America.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Bogus', 'Affiliation': 'Washington University in St. Louis, St. Louis, Missouri, United States of America.'}, {'ForeName': 'Abdel N', 'Initials': 'AN', 'LastName': 'Direny', 'Affiliation': 'RTI International, Washington, District of Columbia, United States of America.'}, {'ForeName': 'Jean Romuald', 'Initials': 'JR', 'LastName': 'Ernest', 'Affiliation': 'IMA World Health, Port-au-Prince, Haiti.'}, {'ForeName': 'Carl R', 'Initials': 'CR', 'LastName': 'Fayette', 'Affiliation': 'IMA World Health, Port-au-Prince, Haiti.'}, {'ForeName': 'Charles W', 'Initials': 'CW', 'LastName': 'Goss', 'Affiliation': 'Washington University in St. Louis, St. Louis, Missouri, United States of America.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Hast', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Kobie', 'Initials': 'K', 'LastName': ""O'Brian"", 'Affiliation': 'Washington University in St. Louis, St. Louis, Missouri, United States of America.'}, {'ForeName': 'Guy Emmanuel', 'Initials': 'GE', 'LastName': 'Pavilus', 'Affiliation': 'IMA World Health, Port-au-Prince, Haiti.'}, {'ForeName': 'Daniel Frantz', 'Initials': 'DF', 'LastName': 'Sabin', 'Affiliation': 'IMA World Health, Port-au-Prince, Haiti.'}, {'ForeName': 'Ryan E', 'Initials': 'RE', 'LastName': 'Wiegand', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Weil', 'Affiliation': 'Washington University in St. Louis, St. Louis, Missouri, United States of America.'}, {'ForeName': 'Jean Frantz', 'Initials': 'JF', 'LastName': 'Lemoine', 'Affiliation': 'Ministère de la Santé et de la Population, Port-au-Prince, Haïti.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0008298']
1987,32499254,The KOMPACT-P study: Knee Osteoarthritis Management with Physiotherapy informed by Acceptance and Commitment Therapy-Pilot study protocol.,"INTRODUCTION


Incidence of total knee arthroplasty (TKA) is projected to rise 276% in 2030, and psychological distress affects up to 42% of people with knee osteoarthritis undergoing TKA, with demonstrated detrimental effects on postoperative outcomes. Few studies have assessed psychological treatment in people awaiting TKA, and these have been psychologist-delivered treatments. No evidence exists regarding psychologically-informed interventions delivered by health professionals currently embedded in TKA clinical pathways. The primary aim of this pilot study is to explore the safety, acceptability and feasibility of the  K nee  O steoarthritis  M anagement with  P hysiotherapy informed by  A cceptance and  C ommitment  T herapy (KOMPACT) approach in people awaiting TKA.
METHODS AND ANALYSIS


51 community-dwelling adults scheduled for a primary TKA at two hospitals will be recruited to this pilot, mixed-methods, prospective randomised controlled trial with assessor blinding. Participants will be randomised in a 1:2 ratio to either usual care (education class) or usual care plus KOMPACT (2 hours 20 min of preoperative physiotherapy informed by Acceptance and Commitment Therapy). Our primary outcome measures are safety (length of stay, complications and psychological health after KOMPACT), acceptability (treatment credibility and qualitative data) and feasibility (recruitment, retention and intervention fidelity) of the KOMPACT approach. Secondary outcomes include health service outcomes, patient-reported physical and psychological outcomes, and physical performance measures. Quantitative data collection was conducted at baseline, 1-2 weeks before TKA, 6 weeks after TKA and 6 months after TKA. Qualitative data collection is 1-2 weeks before TKA. Data analysis will take a quantitative-led approach with triangulation after thematic analysis of the qualitative data.
ETHICS AND DISSEMINATION


This study has full ethics approval (HREC/18/WMEAD/440). Results from this study will be published in peer-reviewed journals and presented at local and international conferences.
TRIAL REGISTRATION NUMBER


Australia New Zealand Clinical Trials Registry (ACTRN12618001867280p).",2020,"A cceptance and  C ommitment  T herapy (KOMPACT) approach in people awaiting TKA.
","['51 community-dwelling adults scheduled for a primary TKA at two hospitals', 'people awaiting TKA']","['cceptance and  C ommitment  T herapy (KOMPACT) approach', 'total knee arthroplasty (TKA', 'usual care (education class) or usual care plus KOMPACT (2\u2009hours 20\u2009min of preoperative physiotherapy informed by Acceptance and Commitment Therapy']","['safety (length of stay, complications and psychological health after KOMPACT), acceptability (treatment credibility and qualitative data) and feasibility (recruitment, retention and intervention fidelity) of the KOMPACT approach', 'health service outcomes, patient-reported physical and psychological outcomes, and physical performance measures', 'safety, acceptability and feasibility of the  K nee']","[{'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.25181,"A cceptance and  C ommitment  T herapy (KOMPACT) approach in people awaiting TKA.
","[{'ForeName': 'Marie K', 'Initials': 'MK', 'LastName': 'March', 'Affiliation': 'Physiotherapy Department, Blacktown Mt Druitt Hospital, Western Sydney Local Health District, Blacktown, New South Wales, Australia Marie.March@health.nsw.gov.au.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Harmer', 'Affiliation': 'Discipline of Physiotherapy, Sydney School of Health Sciences, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Godfrey', 'Affiliation': ""Department of Health Psychology, Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King's College London, London, United Kingdom.""}, {'ForeName': 'Shruti', 'Initials': 'S', 'LastName': 'Venkatesh', 'Affiliation': 'Renal Supportive Care, Nepean Blue Mountains Local Health District, Penrith, New South Wales, Australia.'}, {'ForeName': 'Bijoy', 'Initials': 'B', 'LastName': 'Thomas', 'Affiliation': 'Orthopaedic Department, Blacktown Mt Druitt Hospital, Western Sydney Local Health District, Blacktown, New South Wales, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dennis', 'Affiliation': 'Discipline of Physiotherapy, Sydney School of Health Sciences, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-032675']
1988,32496736,Exercise Training Impacts Skeletal Muscle Clock in Adults with Prediabetes.,"PURPOSE


Disruption of the skeletal muscle molecular clock leads to metabolic disease, while exercise may be restorative, leading to improvements in metabolic health. The purpose of this study was to evaluate the effects of a 12-week exercise intervention on skeletal muscle molecular clock machinery in adults with obesity and prediabetes, and determine whether these changes were related to exercise-induced improvements in metabolic health.
METHODS


Twenty-six adults (age: 66 ± 4.5 yrs; BMI: 34 ± 3.4 kg/m, FPG: 105 ± 15 mg/dL) participated in a 12-week exercise intervention and were fully provided isoenergetic diets. Body composition (DXA), abdominal adiposity (CT scans), peripheral insulin sensitivity (euglycemic-hyperinsulinemic clamp), exercise capacity (VO2max), and skeletal muscle molecular clock machinery (vastus lateralis biopsy) were assessed at baseline and after intervention. Gene and protein expression of skeletal muscle BMAL1, CLOCK, CRY1/2, and PER 1/2 were measured by quantitative real-time PCR and Western blot, respectively.
RESULTS


Body composition (BMI, DXA, CT), peripheral insulin sensitivity (glucose disposal rate; GDR), and exercise capacity (VO2max) all improved (P<0.005) with exercise training. Skeletal muscle BMAL1 gene (fold change: 1.62 ± 1.01; P=0.027) and PER2 protein expression (fold change: 1.35 ± 0.05; P=0.02) increased, while CLOCK, CRY1/2 and PER1 were unchanged. The fold change in BMAL1 correlated with post GDR (r=0.43, P=0.044), BMI (r=-0.44, P=0.042), and body weight changes (r=-0.44, P=0.039) expressed as percent delta.
CONCLUSION


Exercise training impacts skeletal muscle molecular clock machinery in a clinically-relevant cohort of adults with obesity and prediabetes. Skeletal muscle BMAL1 gene expression may improve insulin sensitivity. Future studies are needed to determine the physiological significance of exercise-induced alterations in skeletal muscle clock machinery.",2020,"Skeletal muscle BMAL1 gene (fold change: 1.62 ± 1.01; P=0.027) and PER2 protein expression (fold change: 1.35 ± 0.05; P=0.02) increased, while CLOCK, CRY1/2 and PER1 were unchanged.","['Twenty-six adults (age: 66 ± 4.5 yrs; BMI: 34 ± 3.4 kg/m, FPG: 105 ± 15 mg/dL) participated in a 12-week', 'adults with obesity and prediabetes', 'Adults with Prediabetes']","['exercise intervention', 'Exercise training', 'Exercise Training', 'exercise intervention and were fully provided isoenergetic diets']","['Body composition (DXA), abdominal adiposity (CT scans), peripheral insulin sensitivity (euglycemic-hyperinsulinemic clamp), exercise capacity (VO2max), and skeletal muscle molecular clock machinery (vastus lateralis biopsy', 'Body composition (BMI, DXA, CT), peripheral insulin sensitivity (glucose disposal rate; GDR), and exercise capacity (VO2max', 'Skeletal muscle BMAL1 gene', 'PER2 protein expression', 'BMAL1', 'BMI', 'while CLOCK, CRY1/2 and PER1', 'Gene and protein expression of skeletal muscle BMAL1, CLOCK, CRY1/2, and PER', 'body weight changes']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0337076', 'cui_str': 'Industrial machine'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]",26.0,0.0285188,"Skeletal muscle BMAL1 gene (fold change: 1.62 ± 1.01; P=0.027) and PER2 protein expression (fold change: 1.35 ± 0.05; P=0.02) increased, while CLOCK, CRY1/2 and PER1 were unchanged.","[{'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Erickson', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}, {'ForeName': 'Jacob T', 'Initials': 'JT', 'LastName': 'Mey', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Kirwan', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002368']
1989,32496835,Does person-centred care improve outcomes for musicians fitted with hearing protectors?,"Objective:  To reduce the risk of hearing injury, musicians are often recommended custom-made musicians' hearing protectors (MHP). Studies report benefits of use however, many still report challenges leading to relatively low uptake and inconsistent usage. Person-centred approaches to health have been shown to improve patient outcomes, and these principles may be translatable to musicians' hearing care. The aim was to investigate if use of, and satisfaction with, MHP is influenced by the treatment delivered to musicians by audiologists. Design:  Participants were randomly allocated to one of four conditions that varied in extent of person-centred care. Study sample:  Forty-two musicians with an interest in purchasing MHP were recruited. Results:  Satisfaction with MHP was high overall and users reported a reduction in incidence of tinnitus. Participants reported few issues related to sound quality, however insertion difficulty was the main problem reported. Only one musician self-identified the need for alterations to their MHP. Conclusions:  Adoption of person-centred approaches to MHP was not found to increase likelihood of use, however, satisfaction was high across all conditions. Most often, the need for MHP alterations were clinician-identified during fitting appointments or follow-up contact, underscoring the importance of including these components when providing audiological services to musicians.",2020,"Conclusions:  Adoption of person-centred approaches to MHP was not found to increase likelihood of use, however, satisfaction was high across all conditions.",['Study sample:  Forty-two musicians with an interest in purchasing MHP were recruited'],['MHP'],['incidence of tinnitus'],"[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0543488', 'cui_str': 'Interested'}]",[],"[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}]",42.0,0.0491183,"Conclusions:  Adoption of person-centred approaches to MHP was not found to increase likelihood of use, however, satisfaction was high across all conditions.","[{'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'McGinnity', 'Affiliation': 'Department of Audiology & Speech Pathology, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Elizabeth Francis', 'Initials': 'EF', 'LastName': 'Beach', 'Affiliation': 'The HEARing Cooperative Research Centre, Melbourne, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Cowan', 'Affiliation': 'Department of Audiology & Speech Pathology, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Mulder', 'Affiliation': 'The HEARing Cooperative Research Centre, Melbourne, Australia.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Power', 'Affiliation': 'Department of Audiology & Speech Pathology, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Barr', 'Affiliation': 'Department of Audiology & Speech Pathology, The University of Melbourne, Melbourne, Australia.'}]",International journal of audiology,['10.1080/14992027.2020.1771621']
1990,32502772,The impact of copper impregnated wound dressings on surgical site infection following caesarean section: a double blind randomised controlled study.,"OBJECTIVE


To investigate the effect of copper impregnated wound dressings on the surgical site infection (SSI) rate following caesarean section (CS).
DESIGN


Single centre double blind randomised controlled trial.
PARTICIPANTS


Women aged 18 years or over who had a CS.
INTERVENTIONS


All women were randomised to receive either a copper-oxide impregnated wound dressing (study group) or a non-copper wound dressing (control group).
MAIN OUTCOME MEASURES


The primary study outcome was the incidence of SSI within a 30-day period from CS, assessed via a telephone questionnaire. Secondary outcomes were length of hospital stay, and readmission rate.
RESULTS


324 women were enrolled in the study of whom 159 were randomised to the study group and 165 to the control group. The follow up rate was 97.5%. A total of 78 women (24.1%) developed an SSI within 30 days following CS; 29 (18.2%) in the study group and 49 (29.7%) controls (P = 0.037, relative risk reduction (RRR) of 38.7%). The incidence of superficial/deep SSI was not significantly different (24.2% vs. 17.6%, P = 0.257), however a significant relative risk reduction of 80.3% for Organ/Space SSI was observed in the study group (12.7% vs. 2.5%, P = 0.002). Length of hospital stay, and readmission rate did not vary significantly between groups.
CONCLUSIONS


This is the first study to demonstrate a significant reduction in SSI rates following CS with the use of copper impregnated wound dressings. The high SSI rate confirms the importance of new strategies to reduce the infection rate. Copper is a natural remedy which could potentially reduce hospital acquired infections without the use of antibiotics and its associated risks of antibiotic resistance.",2020,"The incidence of superficial/deep SSI was not significantly different (24.2% vs. 17.6%, P = 0.257), however a significant relative risk reduction of 80.3% for Organ/Space SSI was observed in the study group (12.7% vs. 2.5%, P = 0.002).","['Women aged 18 years or over who had a CS', '324 women were enrolled in the study of whom 159 were randomised to the study group and 165 to the control group', 'surgical site infection following caesarean section']","['caesarean section (CS', 'copper impregnated wound dressings', 'copper-oxide impregnated wound dressing (study group) or a non-copper wound dressing (control group']","['SSI rates', 'infection rate', 'length of hospital stay, and readmission rate', 'incidence of SSI within a 30-day period from CS, assessed via a telephone questionnaire', 'surgical site infection (SSI) rate', 'Length of hospital stay, and readmission rate', 'incidence of superficial/deep SSI']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0460765', 'cui_str': 'Wound management dressing'}, {'cui': 'C0056598', 'cui_str': 'Cupric oxide'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",324.0,0.239103,"The incidence of superficial/deep SSI was not significantly different (24.2% vs. 17.6%, P = 0.257), however a significant relative risk reduction of 80.3% for Organ/Space SSI was observed in the study group (12.7% vs. 2.5%, P = 0.002).","[{'ForeName': 'Linda P', 'Initials': 'LP', 'LastName': 'Arendsen', 'Affiliation': 'Research Fellow, Obstetrics and Gynaecology Department, Croydon University Hospital, United Kingdom. Electronic address: l.p.arendsen@gmail.com.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Thakar', 'Affiliation': 'Consultant Obstetrician and Urogynaecologist, Obstetrics and Gynaecology Department, Croydon University Hospital, United Kingdom. Electronic address: ranee.thakar@nhs.net.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bassett', 'Affiliation': 'Statsconsultancy Ltd, Amersham, United Kingdom. Electronic address: paul@statsconsultancy.co.uk.'}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Sultan', 'Affiliation': ""Consultant Obstetrician and UroGynaecologist, Obstetrics and Gynaecology Department, Croydon University Hospital, 530 London Road, Croydon, CR7 7YE, United Kingdom Honorary Reader, St George's University of London. Electronic address: abdulsultan@nhs.net.""}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.05.016']
1991,32502775,"Lumbar plexus block versus suprainguinal fascia iliaca block for total hip arthroplasty: A single-blinded, randomized trial.","STUDY OBJECTIVE


Comparison of ultrasound-guided lumbar plexus block (LPB) and suprainguinal fascia iliaca block (SIFIB) in patients undergoing total hip arthroplasty (THA).
DESIGN


Randomized equivalence trial.
SETTING


University Hospital.
PATIENTS


Sixty patients undergoing primary THA.
INTERVENTIONS


Patients were randomly allocated to receive ultrasound-guided LPB (n = 30) or SIFIB (n = 30). The local anesthetic agent (40 mL of levobupivacaine 0.25% with epinephrine 5 μg/mL) and block adjuvant (4 mg of intravenous dexamethasone) were identical in all subjects. Postoperatively, all patients received patient-controlled intravenous analgesia (morphine) as well as acetaminophen and ketoprofen during 48 h.
MEASUREMENTS


A blinded investigator recorded morphine consumption at 24 and 48 h as well as time to first morphine request, pain scores at 3, 6, 12, 24 and 48 h, incidence of adverse events, time to readiness for discharge, and length of hospital stay. The blinded investigator also carried out sensorimotor block assessment at 3, 6 and 24 h using a 10-point sensorimotor composite scale.
MAIN RESULTS


No intergroup differences were found in terms of cumulative morphine consumption at 24 h (95% CI: -4.0 mg to 2.0 mg) and 48 h (95% CI, -5.0 mg to 2.0 mg) or time to first morphine request. Furthermore, pain scores were similar at all time intervals after 3 h. There were no intergroup differences in terms of composite sensorimotor scores at 3 and 6 h. However, SIFIB lasted longer than lumbar plexus block as evidenced by a higher composite score at 24 h. No intergroup differences were found in terms of complications. Compared with LPB, SIFIB was associated with shorter time to readiness for discharge (3 [1-4] vs. 2 [1-3] days; P = 0.042) and length of hospital stay (3 [2-5] vs. 3 [2-4] days; P = 0.048).
CONCLUSIONS


For THA, no differences were found between LPB and SIFIB in terms of breakthrough morphine requirement and pain control. However, SIFIB resulted in a longer block and was associated with shorter time to readiness for discharge as well as decreased hospital stay.",2020,No intergroup differences were found in terms of cumulative morphine consumption at 24 h,"['Sixty patients undergoing primary THA', 'University Hospital', 'patients undergoing total hip arthroplasty (THA', 'total hip arthroplasty']","['block adjuvant (4\xa0mg of intravenous dexamethasone', 'acetaminophen and ketoprofen', 'levobupivacaine', 'ultrasound-guided lumbar plexus block (LPB) and suprainguinal fascia iliaca block (SIFIB', 'epinephrine', 'patient-controlled intravenous analgesia (morphine', 'ultrasound-guided LPB', 'Lumbar plexus block versus suprainguinal fascia iliaca block']","['shorter time to readiness for discharge', 'breakthrough morphine requirement and pain control', 'cumulative morphine consumption', 'length of hospital stay', 'complications', 'composite sensorimotor scores', 'adverse events, time to readiness for discharge, and length of hospital stay', 'hospital stay', 'Furthermore, pain scores', 'morphine consumption at 24 and 48\xa0h as well as time to first morphine request, pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0022635', 'cui_str': 'Ketoprofen'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0394731', 'cui_str': 'Lumbar plexus block'}, {'cui': 'C0225261', 'cui_str': 'Iliac fascia structure'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1320402', 'cui_str': 'Readiness for discharge'}, {'cui': 'C0444503', 'cui_str': 'Breakthrough'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1272683', 'cui_str': 'Requested'}]",60.0,0.130543,No intergroup differences were found in terms of cumulative morphine consumption at 24 h,"[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Bravo', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456. Electronic address: dbravoadvis@uchile.cl.'}, {'ForeName': 'Sebastián', 'Initials': 'S', 'LastName': 'Layera', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456.'}, {'ForeName': 'Julián', 'Initials': 'J', 'LastName': 'Aliste', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Jara', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Fernández', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456.'}, {'ForeName': 'Cristián', 'Initials': 'C', 'LastName': 'Barrientos', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Orthopedic Surgery, University of Chile, Third floor, sector B, 999 Santos Dumont, Independencia, Santiago 8380456, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Wulf', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Orthopedic Surgery, University of Chile, Third floor, sector B, 999 Santos Dumont, Independencia, Santiago 8380456, Chile.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Muñoz', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456.'}, {'ForeName': 'Roderick J', 'Initials': 'RJ', 'LastName': 'Finlayson', 'Affiliation': 'Montreal General Hospital, Department of Anesthesiology, McGill University, 1650 Ave Cedar, D10-D144, Montreal, Quebec H3G-1A4, Canada.'}, {'ForeName': 'De Q', 'Initials': 'Q', 'LastName': 'Tran', 'Affiliation': ""St. Mary's Hospital, Department of Anesthesiology, McGill University, 3830 Ave Lacombe, Montreal, Quebec H3T-1M5, Canada.""}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.109907']
1992,32502795,Comparison of underwater gait training and overground gait training for improving the walking and balancing ability of patients with severe hemiplegic stroke: A randomized controlled pilot trial.,"BACKGROUND


Walking training is an essential intervention to improve the function in stroke patients. However, only a limited number of gait training strategies are available for stroke patients with relatively severe disabilities.
RESEARCH QUESTION


Is underwater gait training or overground gait training more effective in severe stroke patients?
METHODS


A total of 21 patients with severe hemiplegic stroke were randomly assigned to the experimental and control groups. All participants (n = 21) received 60-minute sessions of general physical therapy, 5 times a week for a period of 12 weeks. Additionally, the experimental and control groups underwent underwater and overground walking training, respectively, for 30 min twice times a week for 12 weeks. Postural assessment for stroke score, center of pressure path length and velocity, step time and step length difference, and walking velocity were measured before and after the 12-week training.
RESULTS


Both groups showed a significant decrease in the center of pressure path length and velocity after the intervention compared to the values before the intervention (p < .05). However, there was no significant difference in the center of pressure path length and velocity changes after training between the two groups (p > .05). In the walking variables, the step length difference changes after training between the two groups showed a significant difference (p < .05). In the experimental group, the step length difference increased after the intervention compared to that before the intervention (+4.55 cm), whereas that of the control group decreased (-1.25 cm).
SIGNIFICANCE


In severe stroke patients, underwater gait training can be effective for improving balancing ability, but it may be less effective on the improvement of gait function than overground walking.
CLINICAL TRIAL REGISTRATION NUMBER


KCT0002587 (https://cris.nih.go.kr).",2020,"However, there was no significant difference in the center of pressure path length and velocity changes after training between the two groups (p > .05).","['21 patients with severe hemiplegic stroke', 'stroke patients', 'severe stroke patients', 'stroke patients with relatively severe disabilities', 'patients with severe hemiplegic stroke']","['Walking training', 'underwater gait training', '60-minute sessions of general physical therapy', 'underwater and overground walking training', 'underwater gait training and overground gait training', 'underwater gait training or overground gait training']","['center of pressure path length and velocity', 'Postural assessment for stroke score, center of pressure path length and velocity, step time and step length difference, and walking velocity', 'gait function', 'center of pressure path length and velocity changes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",21.0,0.0299419,"However, there was no significant difference in the center of pressure path length and velocity changes after training between the two groups (p > .05).","[{'ForeName': 'Nan-Hyang', 'Initials': 'NH', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, Graduate School of Daejeon University, Republic of Korea. Electronic address: kimnan1004@hanmail.net.'}, {'ForeName': 'Hoon-Young', 'Initials': 'HY', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, Graduate School of Daejeon University, Republic of Korea. Electronic address: phy9234@naver.com.'}, {'ForeName': 'Jin-Kyu', 'Initials': 'JK', 'LastName': 'Son', 'Affiliation': 'Department of Physical Therapy, College of Health and Medical Science, Daejeon University, Republic of Korea. Electronic address: thswlsrb1004@naver.com.'}, {'ForeName': 'Young', 'Initials': 'Y', 'LastName': 'Moon', 'Affiliation': 'Department of Physical Therapy, Graduate School of Daejeon University, Republic of Korea. Electronic address: moyo2ng@naver.com.'}, {'ForeName': 'Jun-Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medical Technology, College of Health and Medical Science, Daejeon University, Republic of Korea. Electronic address: jhlee@dju.kr.'}, {'ForeName': 'Yong-Jun', 'Initials': 'YJ', 'LastName': 'Cha', 'Affiliation': 'Department of Physical Therapy, College of Health and Medical Science, Daejeon University, Republic of Korea. Electronic address: cha0874@dju.kr.'}]",Gait & posture,['10.1016/j.gaitpost.2020.05.022']
1993,32502876,Patient-reported quality of life in patients with relapsed/refractory cutaneous T-cell lymphoma: Results from the randomised phase III ALCANZA study.,"BACKGROUND


Brentuximab vedotin was approved for adult patients with CD30-expressing cutaneous T-cell lymphoma treated with prior systemic therapy based on improved response rates and progression-free survival with brentuximab vedotin (1.8 mg/kg once every 3 weeks; ≤16 cycles) versus physician's choice (methotrexate/bexarotene; ≤48 weeks) in the phase III ALCANZA study. Quality of life (QoL) in ALCANZA patients was also examined.
METHODS


QoL measures in ALCANZA were based on the Skindex-29, Functional Assessment of Cancer Therapy-General (FACT-G) and European QoL 5-dimension (EQ-5D) questionnaires.
RESULTS


Mean maximum reduction from the baseline Skindex-29 symptom domain score (key secondary end-point) was greater with brentuximab vedotin than physician's choice (-27.96 versus -8.62); the difference, -18.9 (95% confidence interval -26.6, -11.2; adjusted p < 0.001), exceeded the study-defined minimally important difference (9.0-12.3). Mean changes from baseline to end-of-treatment visit total FACT-G scores were similar with brentuximab vedotin and physician's choice (0.15 versus -2.29). EQ-5D changes were also comparable between arms. Among brentuximab vedotin-treated patients with peripheral neuropathy (PN), mean maximum reduction in Skindex-29 symptom domain was -35.54 versus -11.11 in patients without PN. PN had no meaningful effect on FACT-G and EQ-5D QoL scores.
CONCLUSIONS


In summary, brentuximab vedotin produced superior reductions in symptom burden compared with physician's choice, without adversely impacting QoL. QoL was unaffected by the presence of PN in brentuximab vedotin-treated patients.
CLINICAL TRIAL REGISTRATION


NCT01578499.",2020,Mean changes from baseline to end-of-treatment visit total FACT-G scores were similar with brentuximab vedotin and physician's choice (0.15 versus -2.29).,"['patients with relapsed/refractory cutaneous T-cell lymphoma', 'adult patients with CD30-expressing\xa0cutaneous T-cell lymphoma treated with prior']","[""physician's choice (methotrexate/bexarotene"", 'Cancer Therapy-General', 'European QoL 5-dimension', 'systemic therapy']","['quality of life', 'Skindex-29 symptom domain', 'FACT-G and EQ-5D QoL scores', 'Quality of life (QoL', 'EQ-5D changes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0079773', 'cui_str': 'Cutaneous T-cell lymphoma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0054950', 'cui_str': 'Lymphocyte antigen CD30'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0765273', 'cui_str': 'bexarotene'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.118026,Mean changes from baseline to end-of-treatment visit total FACT-G scores were similar with brentuximab vedotin and physician's choice (0.15 versus -2.29).,"[{'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Dummer', 'Affiliation': 'Universitäts Spital Zürich, Rämistrasse 100, Zürich 8091, Switzerland. Electronic address: reinhard.dummer@usz.ch.'}, {'ForeName': 'Henry M', 'Initials': 'HM', 'LastName': 'Prince', 'Affiliation': ""Peter MacCallum Cancer Centre, Locked Bag 1, A'Beckett Street, Melbourne, Victoria 8066, Australia. Electronic address: miles.prince@petermac.org.""}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Whittaker', 'Affiliation': 'Division of Genetics and Molecular Medicine, Faculty of Life Sciences and Medicine, Kings College London & Guys and St Thomas NHS Foundation Trust, London, UK. Electronic address: sean.whittaker@gstt.nhs.uk.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Horwitz', 'Affiliation': 'Memorial Hospital, 1275 York Avenue, Between 67th and 68th Streets, New York, NY 10065, USA. Electronic address: horwitzs@MSKCC.ORG.'}, {'ForeName': 'Youn H', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Stanford Clinical Cancer Center, 875 Blake Wilbur Drive, Stanford, CA 94305, USA. Electronic address: younkim@stanford.edu.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Scarisbrick', 'Affiliation': 'Nuffield House, Dermatology - University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre, Birmingham B15 2TH, UK. Electronic address: Julia.Scarisbrick@uhb.nhs.uk.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Quaglino', 'Affiliation': 'University of Turin, Turin, Italy. Electronic address: Pietro.quaglino@unito.it.'}, {'ForeName': 'Pier Luigi', 'Initials': 'PL', 'LastName': 'Zinzani', 'Affiliation': 'Institute of Hematology ""Seràgnoli"", University of Bologna, Via Massarenti 9, Bologna 40138, Italy. Electronic address: pierluigi.zinzani@unibo.it.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Wolter', 'Affiliation': 'University Hospitals Leuven, Leuven, Belgium. Electronic address: pascalwolter@hotmail.com.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Eradat', 'Affiliation': 'Hematology Oncology, UCLA Lymphoma Program, Bone Marrow Transplant Program, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA. Electronic address: Heradat@mednet.ucla.edu.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Pinter-Brown', 'Affiliation': 'Chao Family Comprehensive Cancer Center, University of California, Irvine, CA, USA. Electronic address: lpinterb@uci.edu.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Sanches', 'Affiliation': 'Division of Clinical Dermatology, Hospital Das Clinicas, FMUSP, Department of Dermatology, University of Sao Paulo Medical School, Brazil. Electronic address: jasanchesjr@gmail.com.'}, {'ForeName': 'Pablo L', 'Initials': 'PL', 'LastName': 'Ortiz-Romero', 'Affiliation': 'University Hospital 12 de Octubre, Institute i+12, Medical School, Universidad Complutense, Madrid, Spain. Electronic address: portiz.hdoc@salud.madrid.org.'}, {'ForeName': 'Oleg E', 'Initials': 'OE', 'LastName': 'Akilov', 'Affiliation': 'University of Pittsburgh School of Medicine, Biomedical Science Tower, Room E1157, 200 Lothrop Street, Pittsburgh, PA 15261-2109, USA. Electronic address: akilovoe@upmc.edu.'}, {'ForeName': 'Larisa', 'Initials': 'L', 'LastName': 'Geskin', 'Affiliation': 'Department of Dermatology, Columbia University and CUMC, 161 Fort Washington Ave, 12th Floor, New York, NY 10032, USA. Electronic address: ljg2145@cumc.columbia.edu.'}, {'ForeName': 'Auris', 'Initials': 'A', 'LastName': 'Huen', 'Affiliation': 'University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Box 1452, Houston, TX, USA. Electronic address: aohuen@mdanderson.org.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Walewski', 'Affiliation': 'Maria Sklodowska-Curie National Research Institute of Oncology, 5 WK Roentgen Str, Warszawa 02-781, Poland. Electronic address: jan.walewski@coi.pl.'}, {'ForeName': 'Yinghui', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Seattle Genetics, Inc., Bothell, WA, USA. Electronic address: ywang@seagen.com.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lisano', 'Affiliation': 'Seattle Genetics, Inc., Bothell, WA, USA. Electronic address: jlisano@seagen.com.'}, {'ForeName': 'Akshara', 'Initials': 'A', 'LastName': 'Richhariya', 'Affiliation': 'Seattle Genetics, Inc., Bothell, WA, USA. Electronic address: arichhariya@seagen.com.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Feliciano', 'Affiliation': 'Seattle Genetics, Inc., Bothell, WA, USA. Electronic address: felicianojoseph1@gmail.com.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA. Electronic address: Yanyan.Zhu@takeda.com.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Bunn', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA. Electronic address: Veronica.Bunn@takeda.com.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Little', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA. Electronic address: meredith.little@takeda.com.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Zagadailov', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA. Electronic address: erin.zagadailov@gmail.com.'}, {'ForeName': 'Mehul R', 'Initials': 'MR', 'LastName': 'Dalal', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA. Electronic address: mehul.dalal@takeda.com.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Duvic', 'Affiliation': 'University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Box 1452, Houston, TX, USA. Electronic address: mduvic@mdanderson.org.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.04.010']
1994,32504694,Forty-eight-hour fasting declines mental flexibility but improves balance in overweight and obese older women.,"The purpose of this study was to investigate the effects of a 48-h fast on evoked stress, mood, and cognitive and motor functions in overweight and obese older women. Eleven women (body mass index >25 kg/m 2 ) aged 63-80 years were tested under two randomly allocated conditions: 48-h zero-calorie diet with water provided ad libitum and 48-h usual diet. Autonomic function, cortisol levels, mood state, cognitive performance, visuomotor coordination, motor speed, and balance were evaluated before and after each diet. Fasting increased (P < 0.05) cortisol levels, whereas no changes were observed in heart rate and its variability. Fasting increased (P < 0.05) fatigue, prolonged (P < 0.05) reaction time in the two-choice reaction time test and decreased (P < 0.05) the velocity vector of the center of pressure with eyes closed, whereas no changes in performance were observed in the pursuit tracking and finger tapping tests. Thus, although a 48-h fast resulted in greater hypothalamic-pituitary-adrenal axis activity in overweight and obese older women, autonomic nervous system activity was not affected. Fasting increased fatigue and decreased mental flexibility, but improved balance.",2020,"Fasting increased (P < 0.05) fatigue, prolonged (P < 0.05) reaction time in the two-choice reaction time test and decreased (P < 0.05) the velocity vector of the center of pressure with eyes closed, whereas no changes in performance were observed in the pursuit tracking and finger tapping tests.","['Eleven women (body mass index >25 kg/m 2 ) aged 63-80 years', 'overweight and obese older women']",['48-h zero-calorie diet with water provided ad libitum and 48-h usual diet'],"['evoked stress, mood, and cognitive and motor functions', 'Autonomic function, cortisol levels, mood state, cognitive performance, visuomotor coordination, motor speed, and balance', 'reaction time', 'Fasting increased fatigue and decreased mental flexibility', 'autonomic nervous system activity', 'cortisol levels', 'heart rate and its variability', 'pursuit tracking and finger tapping tests', 'hypothalamic-pituitary-adrenal axis activity', 'Fasting']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0301589', 'cui_str': 'Calorie diet'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}]",,0.0141728,"Fasting increased (P < 0.05) fatigue, prolonged (P < 0.05) reaction time in the two-choice reaction time test and decreased (P < 0.05) the velocity vector of the center of pressure with eyes closed, whereas no changes in performance were observed in the pursuit tracking and finger tapping tests.","[{'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Solianik', 'Affiliation': 'Institute of Sports Science and Innovations, Lithuanian Sports University, Sporto str. 6, LT-44221 Kaunas, Lithuania. Electronic address: rima.solianik@lsu.lt.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Žlibinaitė', 'Affiliation': 'Institute of Sports Science and Innovations, Lithuanian Sports University, Sporto str. 6, LT-44221 Kaunas, Lithuania.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Drozdova-Statkevičienė', 'Affiliation': 'Institute of Sports Science and Innovations, Lithuanian Sports University, Sporto str. 6, LT-44221 Kaunas, Lithuania.'}, {'ForeName': 'Artūras', 'Initials': 'A', 'LastName': 'Sujeta', 'Affiliation': 'Institute of Sports Science and Innovations, Lithuanian Sports University, Sporto str. 6, LT-44221 Kaunas, Lithuania.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.112995']
1995,32506665,The association between serum sex steroid hormone concentrations and intraprostatic inflammation in men without prostate cancer and irrespective of clinical indication for biopsy in the placebo arm of the Prostate Cancer Prevention Trial.,"BACKGROUND


Intraprostatic inflammation is an emerging prostate cancer risk factor. Estrogens are pro-inflammatory while androgens are anti-inflammatory. Thus, we investigated whether serum sex steroid hormone concentrations are associated with intraprostatic inflammation to inform mechanistic links among hormones, inflammation, and prostate cancer.
METHODS


We conducted a cross-sectional study among 247 men in the placebo arm of the Prostate Cancer Prevention Trial who had a negative end-of-study biopsy, most (92.7%) performed without clinical indication per trial protocol. Serum estradiol, estrone, and testosterone were previously measured by immunoassay in pooled baseline and Year 3 serum. Free estradiol and free testosterone were calculated. Inflammation was visually assessed (median of three prostate biopsy cores per man). Polytomous or logistic regression was used to estimate the odds ratio (OR) and 95% confidence interval (CI) of some or all cores inflamed (both vs none) or any core inflamed (vs none) by hormone tertile, adjusting for age, race, and family history. We evaluated effect modification by waist circumference and body mass index (BMI).
RESULTS


In all, 51.4% had some and 26.3% had all cores inflamed. Free (P-trend = .11) but not total estradiol was suggestively inversely associated with all cores inflamed. In men with waist circumference greater than or equal to 102 cm (P-trend = .021) and BMI ≥ 27.09 kg/m 2  (P-trend = .0037) free estradiol was inversely associated with any core inflamed. Estrone was inversely associated with all cores inflamed (T3: OR = 0.36, 95% CI 0.14-0.95, P-trend = .036). Total (T3: OR = 1.91, 95% CI 0.91-4.02, P-trend = .11) and free (T3: OR = 2.19, 95% CI 1.01-4.74, P-trend = .05) testosterone were positively associated with any core inflamed, especially free testosterone in men with waist circumference less than 102 cm (T3: OR = 3.51, 95% CI 1.03-12.11, P-trend = .05).
CONCLUSIONS


In this first study in men without prostate cancer and irrespective of clinical indication for biopsy, contrary to the hypothesis, circulating estrogens appeared to be inversely associated, especially in heavy men, whereas androgens appeared to be positively associated with intraprostatic inflammation.",2020,"Total (T3: OR = 1.91, 95% CI 0.91-4.02, P-trend = .11) and free (T3: OR = 2.19, 95% CI 1.01-4.74, P-trend = .05)","['247 men in the placebo arm of the Prostate Cancer Prevention Trial who had a negative end-of-study biopsy, most (92.7%) performed without clinical indication per trial protocol', 'men without prostate cancer']",[],"['Free estradiol and free testosterone', 'testosterone', 'Inflammation', 'total estradiol', 'waist circumference and body mass index (BMI', 'Serum estradiol, estrone, and testosterone', 'Estrone']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}]",[],"[{'cui': 'C0369189', 'cui_str': 'Free estradiol'}, {'cui': 'C0202228', 'cui_str': 'Testosterone measurement, unbound'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0014942', 'cui_str': 'Estrone'}]",247.0,0.209464,"Total (T3: OR = 1.91, 95% CI 0.91-4.02, P-trend = .11) and free (T3: OR = 2.19, 95% CI 1.01-4.74, P-trend = .05)","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Chadid', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Barber', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Nelson', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Bora', 'Initials': 'B', 'LastName': 'Gurel', 'Affiliation': 'The Institute of Cancer Research, The Royal Marsden, London, UK.'}, {'ForeName': 'M Scott', 'Initials': 'MS', 'LastName': 'Lucia', 'Affiliation': 'Department of Pathology, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Thompson', 'Affiliation': 'The Cancer Therapy and Research Center, CHRISTUS Santa Rosa Hospital-Medical Center, San Antonio, Texas.'}, {'ForeName': 'Phyllis J', 'Initials': 'PJ', 'LastName': 'Goodman', 'Affiliation': 'SWOG Statistical Center, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Frank Z', 'Initials': 'FZ', 'LastName': 'Stanczyk', 'Affiliation': 'Departments of Obstetrics and Gynecology, and Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles, California.'}, {'ForeName': 'Howard L', 'Initials': 'HL', 'LastName': 'Parnes', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Department of Health and Human Services, Bethesda, Maryland.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Lippman', 'Affiliation': 'Moores Cancer Center, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Angelo M', 'Initials': 'AM', 'LastName': 'De Marzo', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Platz', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}]",The Prostate,['10.1002/pros.24023']
1996,32505785,Effect of a 10-month residential multidisciplinary weight loss intervention on food reward in adolescents with obesity.,"BACKGROUND


While multidisciplinary weight loss (WL) programs have been suggested to improve the sensitivity of appetite control system, this study examined for the first time the effect of a specific multidisciplinary intervention on the hedonic aspects of food intake in adolescents with obesity.
STUDY DESIGN


Twenty-four adolescents (11-15 years) with obesity (mean BMI: 35.7 ± 4.5 kg/m 2 ; BMI percentile: 98.7 ± 0.5) took part in a 10-month inpatient WL program, which included physical activity, nutritional education and psychological support. Height, weight, body composition, food reward (pre- and post-meal), ad libitum energy intake, appetite sensations and eating behavior traits were assessed at baseline, 5 months and at the end of the 10-month intervention. Analyses were conducted with linear mixed models and paired t-tests.
RESULTS


The mean WL was 8.9 ± 6.9 kg. Appetite sensations and pre-meal hedonic ratings of liking for all food categories (HF: high-fat; LF: low-fat; SA: savory; SW: sweet) increased after 5 months (fasting hunger, p = 0.02; fasting desire to eat, p = 0.01; daily hunger, p = 0.001; pre-meal liking for HFSA, p = 0.03; LFSA, p = 0.04; HFSW, p = 0.009; LFSW, p = 0.005). In contrast, appetite sensations (fasting and daily), emotional eating (p < 0.001), uncontrolled eating (p = 0.009), and pre-meal explicit liking (for all food categories) decreased between months 5 and 10. Post-meal liking for HFSA (p < 0.001), LFSA (p = 0.002), HFSW (p = 0.02) and LFSW (p < 0.001) decreased between baseline and month 5 and remained unchanged between months 5 and 10.
CONCLUSION


These findings suggest that adaptive mechanisms to WL occurring in the short-to-medium term are attenuated in the longer term with the persistence of WL. These results indicate improvements in the reward response to food in adolescents with obesity and may contribute to the beneficial effect of multicomponent WL interventions in this population. Future studies are required to confirm these findings and elucidate underlying mechanisms.",2020,Post-meal liking for HFSA (p<0.001),"['adolescents with obesity', 'Twenty-four adolescents (11-15 years) with obesity']",['residential multidisciplinary weight loss intervention'],"['Height, weight, body composition, food reward (pre- and post-meal), ad libitum energy intake, appetite sensations and eating behavior traits', 'appetite sensations (fasting and daily), emotional eating (p<0.001), uncontrolled eating (p=0.009), and pre-meal explicit liking', 'HFSW', 'Appetite sensations and pre-meal hedonic ratings of liking']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]",24.0,0.0263658,Post-meal liking for HFSA (p<0.001),"[{'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Miguet', 'Affiliation': 'Clermont Auvergne University, EA 3533, Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont-Ferrand, France. Electronic address: maud.miguet@neuro.uu.se.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Beaulieu', 'Affiliation': 'School of Psychology, Faculty of Medicine and Health, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Fillon', 'Affiliation': 'Clermont Auvergne University, EA 3533, Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont-Ferrand, France.'}, {'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Khammassi', 'Affiliation': 'Clermont Auvergne University, EA 3533, Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont-Ferrand, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Masurier', 'Affiliation': 'UGECAM Nutrition Obesity Ambulatory Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Lambert', 'Affiliation': 'Clermont-Ferrand University Hospital, Biostatistics Unit (DRCI), Clermont-Ferrand, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Duclos', 'Affiliation': 'Department of Sport Medicine and Functional Explorations, Clermont-Ferrand University Hospital, G. Montpied Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Boirie', 'Affiliation': 'Department of Human Nutrition, Clermont-Ferrand University Hospital, G. Montpied Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Finlayson', 'Affiliation': 'School of Psychology, Faculty of Medicine and Health, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Thivel', 'Affiliation': 'Clermont Auvergne University, EA 3533, Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont-Ferrand, France.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.112996']
1997,32512124,Placebo-induced pain reduction is associated with negative coupling between brain networks at rest.,"Placebos can reduce pain by inducing beliefs in the effectiveness of an actually inert treatment. Such top-down effects on pain typically engage lateral and medial prefrontal regions, the insula, somatosensory cortex, as well as the thalamus and brainstem during pain anticipation or perception. Considering the level of large-scale brain networks, these regions spatially align with fronto-parietal/executive control, salience, and sensory-motor networks, but it is unclear if and how placebos alter interactions between them during rest. Here, we investigated how placebo analgesia affected intrinsic network coupling. Ninety-nine human participants were randomly assigned to a placebo or control group and underwent resting-state fMRI after pain processing. Results revealed inverse coupling between two resting-state networks in placebo but not control participants. Specifically, networks comprised the bilateral somatosensory cortex and posterior insula, as well as the brainstem, thalamus, striatal regions, dorsal and rostral anterior cingulate cortex, and the anterior insula, respectively. Across participants, more negative between-network coupling was associated with lower individual pain intensity as assessed during a preceding pain task, and there was no significant relation with expectations of medication effectiveness in the placebo group. Altogether, these findings provide initial evidence that placebo analgesia affects the intrinsic communication between large-scale brain networks, even in the absence of pain. We suggest a theoretical model where placebo analgesia might affect processing within a descending pain-modulatory network, potentially segregating it from somatosensory regions that may code for painful experiences.",2020,"Across participants, more negative between-network coupling was associated with lower individual pain intensity as assessed during a preceding pain task, and there was no significant relation with expectations of medication effectiveness in the placebo group.",['Ninety-nine human participants'],"['Placebos', 'Placebo', 'placebo or control group and underwent resting-state fMRI after pain processing', 'placebo']","['individual pain intensity', 'pain reduction', 'medication effectiveness', 'pain']","[{'cui': 'C3828813', 'cui_str': '99'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0423732', 'cui_str': 'After pains'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",99.0,0.206348,"Across participants, more negative between-network coupling was associated with lower individual pain intensity as assessed during a preceding pain task, and there was no significant relation with expectations of medication effectiveness in the placebo group.","[{'ForeName': 'Isabella C', 'Initials': 'IC', 'LastName': 'Wagner', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010, Vienna, Austria. Electronic address: isabella.wagner@univie.ac.at.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Rütgen', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010, Vienna, Austria.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Hummer', 'Affiliation': 'MR Centre of Excellence, Centre for Medical Physics and Biomedical Engineering, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Windischberger', 'Affiliation': 'MR Centre of Excellence, Centre for Medical Physics and Biomedical Engineering, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Lamm', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010, Vienna, Austria.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117024']
1998,32512127,"Creating while taking turns, the choice to unlocking group creative potential.","This study aimed to examine how communication modes affect creative idea generation in groups. Three communication mode conditions were created: natural (N), turn-taking (T), and electronic brainstorming (E). Participants were randomly recruited and grouped in dyads to solve one alternative uses task (AUT) in each condition, during which functional near-infrared spectroscopy (fNIRS)-based hyperscanning was used to record interpersonal neural responses. No difference was observed in AUT fluency across the three conditions, but AUT uniqueness was higher in the T condition than in the E condition. In addition, AUT uniqueness, AUT fluency, and perspective-taking behaviours increased faster in the T condition than in the other conditions. The T condition also showed higher perspective-taking behaviours than did the other conditions. Moreover, fNIRS data showed higher interpersonal brain synchronisation (IBS) increments at the right angular gyrus in the T condition than in the other conditions, which positively predicted perspective-taking behaviours between individuals during group creativity tasks. These findings indicate that when group members create together while taking turns, both creative performance and interpersonal interaction processes can be stimulated.",2020,"No difference was observed in AUT fluency across the three conditions, but AUT uniqueness was higher in the T condition than in the E condition.",[],[],"['AUT fluency, and perspective-taking behaviours', 'perspective-taking behaviours', 'interpersonal brain synchronisation (IBS', 'AUT fluency']",[],[],"[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}]",,0.0212556,"No difference was observed in AUT fluency across the three conditions, but AUT uniqueness was higher in the T condition than in the E condition.","[{'ForeName': 'Kelong', 'Initials': 'K', 'LastName': 'Lu', 'Affiliation': 'Shanghai Key Laboratory of Brain Functional Genomics, School of Psychology and Cognitive Science, East China Normal University, Shanghai, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': 'Shanghai Key Laboratory of Brain Functional Genomics, School of Psychology and Cognitive Science, East China Normal University, Shanghai, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Hao', 'Affiliation': 'Shanghai Key Laboratory of Brain Functional Genomics, School of Psychology and Cognitive Science, East China Normal University, Shanghai, China. Electronic address: nhao@psy.ecnu.edu.cn.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117025']
1999,32513308,Evaluating the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in severely ill adults with COVID-19: A structured summary of a study protocol for a randomized controlled trial.,"OBJECTIVES


The aim of this study is to evaluate the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in hospitalized adults with severe SARS-CoV-2 infection.
TRIAL DESIGN


This is a prospective, single-center, phase 2, randomized, controlled trial that is blinded to participants and clinical outcome assessor.
PARTICIPANTS


Eligible participants include adults (≥ 18 years) with evidence of SARS-CoV-2 infection by PCR test of nasopharyngeal or oropharyngeal swab within 14 days of randomization, evidence of infiltrates on chest radiography, peripheral capillary oxygen saturation (SpO2) ≤ 94% on room air, and/or need for supplemental oxygen, non-invasive mechanical ventilation, or invasive mechanical ventilation, who are willing and able to provide written informed consent prior to performing study procedures or who have a legally authorized representative available to do so. Exclusion criteria include participation in another clinical trial of anti-viral agent(s)* for coronavirus disease-2019 (COVID-19), receipt of any anti-viral agent(s)* with possible activity against SARS-CoV-2 <24 hours prior to plasma infusion, mechanical ventilation (including extracorporeal membrane oxygenation [ECMO]) for ≥ 5 days, severe multi-organ failure, history of allergic reactions to transfused blood products per NHSN/CDC criteria, known IgA deficiency, and pregnancy. Included participants will be hospitalized at the time of randomization and plasma infusion. *Use of remdesivir as treatment for COVID-19 is permitted. The study will be undertaken at Columbia University Irving Medical Center in New York, USA.
INTERVENTION AND COMPARATOR


The investigational treatment is anti-SARS-CoV-2 human convalescent plasma. To procure the investigational treatment, volunteers who recovered from COVID-19 will undergo testing to confirm the presence of anti-SARS-CoV-2 antibody to the spike trimer at a 1:400 dilution. Donors will also be screened for transfusion-transmitted infections (e.g. HIV, HBV, HCV, WNV, HTLV-I/II, T. cruzi, ZIKV). If donors have experienced COVID-19 symptoms within 28 days, they will be screened with a nasopharyngeal swab to confirm they are SARS-CoV-2 PCR-negative. Plasma will be collected using standard apheresis technology by the New York Blood Center. Study participants will be randomized in a 2:1 ratio to receive one unit (200 - 250 mL) of anti-SARS-CoV-2 plasma versus one unit (200 - 250 mL) of the earliest available control plasma. The control plasma cannot be tested for presence of anti-SARS-CoV-2 antibody prior to the transfusion, but will be tested for anti- SARS-CoV-2 antibody after the transfusion to allow for a retrospective per-protocol analysis.
MAIN OUTCOMES


The primary endpoint is time to clinical improvement. This is defined as time from randomization to either discharge from the hospital or improvement by one point on the following seven-point ordinal scale, whichever occurs first. 1. Not hospitalized with resumption of normal activities 2. Not hospitalized, but unable to resume normal activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, requiring high-flow oxygen therapy or non-invasive mechanical ventilation 6. Hospitalized, requiring ECMO, invasive mechanical ventilation, or both 7. Death This scale, designed to assess clinical status over time, was based on that recommended by the World Health Organization for use in determining efficacy end-points in clinical trials in hospitalized patients with COVID-19. A recent clinical trial evaluating the efficacy and safety of lopinavir- ritonavir for patients hospitalized with severe COVID-19 used a similar ordinal scale, as have recent clinical trials of novel therapeutics for severe influenza, including a post-hoc analysis of a trial evaluating immune plasma. The primary safety endpoints are cumulative incidence of grade 3 and 4 adverse events and cumulative incidence of serious adverse events during the study period.
RANDOMIZATION


Study participants will be randomized in a 2:1 ratio to receive anti-SARS-CoV-2 plasma versus control plasma using a web-based randomization platform. Treatment assignments will be generated using randomly permuted blocks of different sizes to minimize imbalance while also minimizing predictability.
BLINDING (MASKING)


The study participants and the clinicians who will evaluate post-treatment outcomes will be blinded to group assignment. The blood bank and the clinical research team will not be blinded to group assignment.
NUMBERS TO BE RANDOMIZED (SAMPLE SIZE)


We plan to enroll 129 participants, with 86 in the anti-SARS-CoV-2 arm, and 43 in the control arm. Among the participants, we expect ~70% or n = 72 will achieve clinical improvement. This will yield an 80% power for a one-sided Wald test at 0.15 level of significance under the proportional hazards model with a hazard ratio of 1.5.
TRIAL STATUS


Protocol AAAS9924, Version 17APR2020, 4/17/2020 Start of recruitment: April 20, 2020 Recruitment is ongoing.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT04359810 Date of trial registration: April 24, 2020 Retrospectively registered FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"The control plasma cannot be tested for presence of anti-SARS-CoV-2 antibody prior to the transfusion, but will be tested for anti- SARS-CoV-2 antibody after the transfusion to allow for a retrospective per-protocol analysis.
","['hospitalized patients with COVID-19', 'patients hospitalized with severe COVID-19 used a similar ordinal scale', 'severely ill adults with COVID-19', 'Hospitalized, requiring high-flow oxygen therapy or non-invasive mechanical ventilation 6', 'enroll 129 participants, with 86 in the anti-SARS-CoV-2 arm, and 43 in the control arm', 'hospitalized adults with severe SARS-CoV-2 infection', 'Eligible participants include adults (≥ 18 years) with evidence of SARS-CoV-2 infection by PCR test of nasopharyngeal or oropharyngeal swab within 14 days of randomization, evidence of infiltrates on chest radiography, peripheral capillary oxygen saturation (SpO2) ≤ 94% on room air, and/or need for supplemental oxygen, non-invasive mechanical ventilation, or invasive mechanical ventilation, who are willing and able to provide written informed consent prior to performing study procedures or who have a legally authorized representative available to do so', 'Columbia University Irving Medical Center in New York, USA']","['lopinavir- ritonavir', 'possible activity against SARS-CoV-2 <24 hours prior to plasma infusion, mechanical ventilation (including extracorporeal membrane oxygenation [ECMO', 'human anti-SARS-CoV-2 convalescent plasma', 'anti-SARS-CoV-2 plasma versus control plasma using a web-based randomization platform', 'anti-SARS-CoV-2 plasma versus one unit']","['efficacy and safety', 'time to clinical improvement', 'Death', 'cumulative incidence of grade 3 and 4 adverse events and cumulative incidence of serious adverse events']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0183753', 'cui_str': 'Swab'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0428178', 'cui_str': 'Capillary oxygen saturation measurement'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0021613', 'cui_str': 'Inspiratory reserve volume'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0278347', 'cui_str': 'Transfusion of plasma'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.269262,"The control plasma cannot be tested for presence of anti-SARS-CoV-2 antibody prior to the transfusion, but will be tested for anti- SARS-CoV-2 antibody after the transfusion to allow for a retrospective per-protocol analysis.
","[{'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Eckhardt', 'Affiliation': 'Columbia University Medical Center, New York, USA. cme2113@cumc.columbia.edu.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Cummings', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Kartik N', 'Initials': 'KN', 'LastName': 'Rajagopalan', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Borden', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Zachary C', 'Initials': 'ZC', 'LastName': 'Bitan', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Wolf', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kantor', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Briese', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Meyer', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Samuel D', 'Initials': 'SD', 'LastName': 'Jacobson', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Scotto', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Nischay', 'Initials': 'N', 'LastName': 'Mishra', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Neena M', 'Initials': 'NM', 'LastName': 'Philip', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Brie A', 'Initials': 'BA', 'LastName': 'Stotler', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Schwartz', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Shaz', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Spitalnik', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Eisenberger', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Eldad A', 'Initials': 'EA', 'LastName': 'Hod', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Justman', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Cheung', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'W Ian', 'Initials': 'WI', 'LastName': 'Lipkin', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Max R', 'Initials': 'MR', 'LastName': ""O'Donnell"", 'Affiliation': 'Columbia University Medical Center, New York, USA.'}]",Trials,['10.1186/s13063-020-04422-y']
2000,32515058,Randomized controlled trial of social cognition and interaction training compared to befriending group.,"BACKGROUND


Deficits in social cognition are common in people with schizophrenia and are associated with impaired functioning. Finding effective interventions to address these deficits is a priority. Social Cognition Interaction Training (SCIT) is a psychosocial intervention that has demonstrated acceptability and feasibility in various health care settings. Larger, well-designed randomized controlled trials are needed to examine the effectiveness of this intervention.
DESIGN


A randomized controlled trial.
METHODS


One hundred and twenty adults diagnosed with schizophrenia spectrum disorder were randomized to receive SCIT (n = 61) or Befriending Therapy (BT) (n = 59). Both intervention groups were delivered weekly for 2 hr over 12 weeks. Neurocognitive assessment was completed at baseline. Participants completed assessments of social cognition, social functioning, and meta-cognition at baseline, post-intervention, and 3-month follow-up.
RESULTS


There were no clinically significant differences between group outcomes on any measure of social cognition or social functioning. There was a trend for both groups to improve over time but not at a level of statistical significance.
CONCLUSIONS


SCIT did not show any additional benefits on measures of social cognition compared to Befriending Therapy for people with schizophrenia spectrum disorder. The findings are discussed in terms of potential improvements to the programme.
PRACTITIONER POINTS


Effective interventions for the social cognitive deficits of schizophrenia spectrum disorders are still being refined. Social Cognition Interaction Training is a promising therapy but requires further modifications to improve its effectiveness.",2020,"CONCLUSIONS


SCIT did not show any additional benefits on measures of social cognition compared to Befriending Therapy for people with schizophrenia spectrum disorder.","['people with schizophrenia spectrum disorder', 'One hundred and twenty adults diagnosed with schizophrenia spectrum disorder', 'people with schizophrenia']","['SCIT', 'Social Cognition Interaction Training', 'Social Cognition Interaction Training (SCIT', 'social cognition and interaction training', 'Befriending Therapy (BT']","['Neurocognitive assessment', 'social cognition, social functioning, and meta-cognition', 'social cognition', 'social cognition or social functioning']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0589513', 'cui_str': 'Metacognition'}]",120.0,0.0376513,"CONCLUSIONS


SCIT did not show any additional benefits on measures of social cognition compared to Befriending Therapy for people with schizophrenia spectrum disorder.","[{'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Dark', 'Affiliation': 'Metro South Addiction and Mental Health Services, Metro South Addiction and Mental Health Services, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Scott', 'Affiliation': 'Faculty of Medicine, Level 3 UQ Centre for Clinical Research (UQCCR), Herston, Queensland, Australia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Baker', 'Affiliation': 'Queensland Centre for Mental Health Research, Clinical Support Unit, The Park-Centre for Mental Health, Archerfield, Queensland, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Parker', 'Affiliation': 'Postgraduate Training in Psychiatry, Addiction and Mental Health Services I Metro South Health Blg 23, Garden City Office Park, Eight Mile Plains, Queensland, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Gordon', 'Affiliation': 'Early Psychosis Service, Metro North Mental Health, Herston, Queensland, Australia.'}, {'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Newman', 'Affiliation': 'St Kilda Road Clinic Community Adult Mental Health, Alfred Psychiatry, Melbourne, Victoria, Australia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Gore-Jones', 'Affiliation': 'Metro South Addiction and Mental Health Services, Metro South Addiction and Mental Health Services, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia.'}, {'ForeName': 'Carmen C W', 'Initials': 'CCW', 'LastName': 'Lim', 'Affiliation': 'Queensland Centre for Mental Health Research, Clinical Support Unit, The Park-Centre for Mental Health, Archerfield, Queensland, Australia.'}, {'ForeName': 'Lyndall', 'Initials': 'L', 'LastName': 'Jones', 'Affiliation': 'Pine Rivers Community Health Centre, Strathpine, Queensland, Australia.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Penn', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina-Chapel Hill, Chapel Hill, North Carolina, USA.'}]",The British journal of clinical psychology,['10.1111/bjc.12252']
2001,32517497,Icare versus Goldmann in a randomised middle-aged population: The influence of central corneal thickness and refractive errors.,"PURPOSE


The aim of this study was to compare the measurements of intraocular pressure by two tonometers, the Icare rebound tonometer and the Goldmann applanation tonometer, in a randomised screening study. The influence of refraction and central corneal thickness on the measurements was also evaluated.
METHODS


Intraocular pressure was measured with rebound tonometer and Goldmann applanation tonometer in 1266 participants; refraction and central corneal thickness were also determined. One randomised eye of each participant was selected for this report's analysis. A Bland-Altman plot was used to compare the values obtained with the two devices.
RESULTS


The correlation between rebound tonometer and Goldmann applanation tonometer was good: the intraclass correlation coefficient (r) between the two methods was 0.735 ( p  < 0.001). The mean difference (rebound tonometer-Goldmann applanation tonometer) was 0.11 ± 2.3 mmHg. The difference was not statistically significant (95% confidence interval: 0.11 to 0.13,  p  = 0.09). With increasing central corneal thickness, not only did intraocular pressure values with both devices increase, but the difference between them also increased. Refraction (spherical equivalent) did not influence intraocular pressure or the rebound tonometer-Goldmann applanation tonometer difference. However, high astigmatism (≥2D) exerted an influence on intraocular pressure values taken with Goldmann applanation tonometer.
CONCLUSION


Measurements with rebound tonometer and Goldmann applanation tonometer are relatively uniform although rebound tonometer slightly overestimated intraocular pressure. Both rebound tonometer and Goldmann applanation tonometer and the difference between these devices were affected by central corneal thickness but not by refraction. Higher astigmatism affected Goldmann applanation tonometer more than rebound tonometer. It is concluded that rebound tonometer is a reliable method for measuring intraocular pressure in a population-based screening study.",2020,The correlation between rebound tonometer and Goldmann applanation tonometer was good: the intraclass correlation coefficient (r) between the two methods was 0.735 (,['1266 participants'],"['Icare versus Goldmann', 'Icare rebound tonometer and the Goldmann applanation tonometer', 'rebound tonometer and Goldmann applanation tonometer']","['Goldmann applanation tonometer', 'intraocular pressure or the rebound tonometer-Goldmann applanation tonometer difference', 'mean difference (rebound tonometer-Goldmann applanation tonometer', 'intraocular pressure values', 'rebound tonometer and Goldmann applanation tonometer', 'intraocular pressure', 'central corneal thickness', 'refraction and central corneal thickness']",[],"[{'cui': 'C0183969', 'cui_str': 'Tonometer'}, {'cui': 'C1271528', 'cui_str': 'Goldmann applanation tonometer'}]","[{'cui': 'C1271528', 'cui_str': 'Goldmann applanation tonometer'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0183969', 'cui_str': 'Tonometer'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}]",1266.0,0.0730484,The correlation between rebound tonometer and Goldmann applanation tonometer was good: the intraclass correlation coefficient (r) between the two methods was 0.735 (,"[{'ForeName': 'Katri', 'Initials': 'K', 'LastName': 'Stoor', 'Affiliation': 'Department of Ophthalmology, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Karvonen', 'Affiliation': 'Department of Ophthalmology, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Pasi', 'Initials': 'P', 'LastName': 'Ohtonen', 'Affiliation': 'Medical Research Center Oulu, University of Oulu, Oulu, Finland.'}, {'ForeName': 'M Johanna', 'Initials': 'MJ', 'LastName': 'Liinamaa', 'Affiliation': 'Department of Ophthalmology, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Saarela', 'Affiliation': 'Department of Ophthalmology, Oulu University Hospital, Oulu, Finland.'}]",European journal of ophthalmology,['10.1177/1120672120921380']
2002,32520316,Association of Naturalistic Administration of Cannabis Flower and Concentrates With Intoxication and Impairment.,"Importance


The rapidly growing legal cannabis market includes new and highly potent products, the effects of which, to our knowledge, have not previously been examined in biobehavioral research studies because of federal restrictions on cannabis research.
Objective


To use federally compatible, observational methods to study high-∆9-tetrahydrocannabinol (THC) legal market forms of cannabis.
Design, Setting, and Participants


In this cohort study with a between-groups design that was conducted in a community and university setting, cannabis flower users and concentrate users were randomly assigned to higher- vs lower-THC products within user groups. Participants completed a baseline and an experimental mobile laboratory assessment that included 3 points: before, immediately after, and 1 hour after ad libitum legal market flower and concentrate use. Of the 133 individuals enrolled and assessed, 55 regular flower cannabis users (41.4%) and 66 regular concentrate cannabis users (49.6%) complied with the study's cannabis use instructions and had complete data across primary outcomes.
Exposures


Flower users were randomly assigned to use either 16% or 24% THC flower and concentrate users were randomly assigned to use either 70% or 90% THC concentrate that they purchased from a dispensary.
Main Outcomes and Measures


Primary outcome measures included plasma cannabinoids, subjective drug intoxication, and neurobehavioral tasks testing attention, memory, inhibitory control, and balance.
Results


A total of 121 participants completed the study for analysis: 55 flower users (mean [SD] age, 28.8 [8.1] years; 25 women [46%]) and 66 concentrate users (mean [SD] age, 28.3 [10.4] years; 30 women [45%]). Concentrate users compared with flower users exhibited higher plasma THC levels and 11-hydroxyΔ9-THC (THC's active metabolite) across all points. After ad libitum cannabis administration, mean plasma THC levels were 1016 (SE = 1380) μg/mL in concentrate users (to convert to millimoles per liter, multiply by 3.18) and 455 (SE = 503) μg/mL in flower users. Most neurobehavioral measures were not altered by short-term cannabis consumption. However, delayed verbal memory (F1,203 = 32.31; P < .001) and balance function (F1,203 = 18.88; P < .001) were impaired after use. Differing outcomes for the type of product (flower vs concentrate) or potency within products were not observed.
Conclusions and Relevance


This study provides information about the association of pharmacological and neurobehavioral outcomes with legal market cannabis. Short-term use of concentrates was associated with higher levels of THC exposure. Across forms of cannabis and potencies, users' domains of verbal memory and proprioception-focused postural stability were primarily associated with THC administration.",2020,"However, delayed verbal memory (F1,203 = 32.31; P < .001) and balance function (F1,203 = 18.88; P < .001) were impaired after use.","['community and university setting, cannabis flower users and concentrate users', 'Exposures\n\n\nFlower users', ""133 individuals enrolled and assessed, 55 regular flower cannabis users (41.4%) and 66 regular concentrate cannabis users (49.6%) complied with the study's cannabis use instructions and had complete data across primary outcomes"", '121 participants completed the study for analysis: 55 flower users (mean [SD] age, 28.8 [8.1] years; 25 women [46%]) and 66 concentrate users (mean [SD] age, 28.3']","['THC flower and concentrate users were randomly assigned to use either 70% or 90% THC concentrate that they purchased from a dispensary', 'higher- vs lower-THC products']","[""plasma THC levels and 11-hydroxyΔ9-THC (THC's active metabolite"", 'mean plasma THC levels', 'verbal memory and proprioception-focused postural stability', 'balance function', 'THC exposure', 'delayed verbal memory', 'plasma cannabinoids, subjective drug intoxication, and neurobehavioral tasks testing attention, memory, inhibitory control, and balance']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0330090', 'cui_str': 'Flowers'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0330090', 'cui_str': 'Flowers'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0589137', 'cui_str': 'Delayed verbal memory'}, {'cui': 'C0006864', 'cui_str': 'cannabinoids'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0013221', 'cui_str': 'Poisoning by drug AND/OR medicinal substance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",121.0,0.322435,"However, delayed verbal memory (F1,203 = 32.31; P < .001) and balance function (F1,203 = 18.88; P < .001) were impaired after use.","[{'ForeName': 'L Cinnamon', 'Initials': 'LC', 'LastName': 'Bidwell', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado, Boulder.'}, {'ForeName': 'Jarrod M', 'Initials': 'JM', 'LastName': 'Ellingson', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado, Boulder.'}, {'ForeName': 'Hollis C', 'Initials': 'HC', 'LastName': 'Karoly', 'Affiliation': 'Institute for Cognitive Science, University of Colorado, Boulder.'}, {'ForeName': 'Sophie L', 'Initials': 'SL', 'LastName': 'YorkWilliams', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado, Boulder.'}, {'ForeName': 'Leah N', 'Initials': 'LN', 'LastName': 'Hitchcock', 'Affiliation': 'Institute for Cognitive Science, University of Colorado, Boulder.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Tracy', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins.'}, {'ForeName': 'Jost', 'Initials': 'J', 'LastName': 'Klawitter', 'Affiliation': 'Division of Substance Dependence, Department of Psychiatry, University of Colorado, Aurora.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Sempio', 'Affiliation': 'Department of Anesthesiology, University of Colorado, Aurora.'}, {'ForeName': 'Angela D', 'Initials': 'AD', 'LastName': 'Bryan', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado, Boulder.'}, {'ForeName': 'Kent E', 'Initials': 'KE', 'LastName': 'Hutchison', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado, Boulder.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.0927']
2003,32498620,Study Design and Rationale of EXPLORER-HCM: Evaluation of Mavacamten in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy.,"BACKGROUND


Obstructive hypertrophic cardiomyopathy (oHCM) is characterized by unexplained left ventricular (LV) hypertrophy associated with dynamic LV outflow tract obstruction. Current medical therapies are nonspecific and have limited efficacy in relieving symptoms. Mavacamten is a first-in-class targeted inhibitor of cardiac myosin, which has been shown to reduce LV outflow tract obstruction, improve exercise capacity, and relieve symptoms of oHCM in the PIONEER-HCM phase 2 study.
METHODS


EXPLORER-HCM is a multicenter, phase 3, randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of mavacamten in treating symptomatic oHCM. Eligible adults with oHCM and New York Heart Association Functional Class II or III are randomized 1:1 to receive once-daily, oral mavacamten, or matching placebo for 30 weeks. The primary composite functional end point is clinical response at week 30 compared to baseline defined as either (1) an increase in peak oxygen consumption ≥1.5 mL/kg/min and reduction of at least one New York Heart Association class; or (2) an improvement of ≥3.0 mL/kg/min in peak oxygen consumption with no worsening of New York Heart Association class. Secondary end points include change in postexercise LV outflow tract gradient, New York Heart Association class, peak oxygen consumption, and patient-reported outcomes assessed by the Kansas City Cardiomyopathy Questionnaire and a novel HCM-specific instrument. Exploratory end points aim to characterize the effect of mavacamten on multiple aspects of oHCM pathophysiology.
CONCLUSIONS


EXPLORER-HCM is a phase 3 trial in oHCM testing a first-in-class, targeted strategy of myosin inhibition to improve symptom burden and exercise capacity through reducing LV outflow tract obstruction. Results of this trial will provide evidence to support the first disease-specific treatment for HCM. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03470545.",2020,"Secondary end points include change in postexercise LV outflow tract gradient, New York Heart Association class, peak oxygen consumption, and patient-reported outcomes assessed by the Kansas City Cardiomyopathy Questionnaire and a novel HCM-specific instrument.","['Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy', 'Eligible adults with oHCM and New York Heart Association Functional Class II or III']","['mavacamten', 'oral mavacamten, or matching placebo', 'EXPLORER-HCM', 'Mavacamten', 'placebo']","['change in postexercise LV outflow tract gradient, New York Heart Association class, peak oxygen consumption, and patient-reported outcomes assessed by the Kansas City Cardiomyopathy Questionnaire and a novel HCM-specific instrument', 'efficacy and safety', 'clinical response', 'peak oxygen consumption ≥1.5 mL/kg/min and reduction of at least one New York Heart Association class; or (2) an improvement of ≥3.0 mL/kg/min in peak oxygen consumption']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C4551472', 'cui_str': 'Hypertrophic obstructive cardiomyopathy'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0262500', 'cui_str': 'Routine health maintenance'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0225912', 'cui_str': 'Structure of outflow tract of left ventricle'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0262500', 'cui_str': 'Routine health maintenance'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.241001,"Secondary end points include change in postexercise LV outflow tract gradient, New York Heart Association class, peak oxygen consumption, and patient-reported outcomes assessed by the Kansas City Cardiomyopathy Questionnaire and a novel HCM-specific instrument.","[{'ForeName': 'Carolyn Y', 'Initials': 'CY', 'LastName': 'Ho', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA (C.Y.H.).""}, {'ForeName': 'Iacopo', 'Initials': 'I', 'LastName': 'Olivotto', 'Affiliation': 'Careggi University Hospital, Florence, Italy (I.O.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Jacoby', 'Affiliation': 'Yale University, New Haven, CT (D.J.).'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Lester', 'Affiliation': 'Mayo Clinic, Phoenix, AZ (S.J.L.).'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Roe', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (M.R.).'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Duke University School of Medicine, Durham, NC (A.W.).'}, {'ForeName': 'Cynthia Burstein', 'Initials': 'CB', 'LastName': 'Waldman', 'Affiliation': 'HCMBeat.com, Los Angeles, CA (C.B.W.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'MyoKardia, Inc, Brisbane, CA (D.Z., A.J.S.).'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Sehnert', 'Affiliation': 'MyoKardia, Inc, Brisbane, CA (D.Z., A.J.S.).'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Heitner', 'Affiliation': 'Knight Cardiovascular Institute, Oregon Health and Sciences University, Portland (S.B.H.).'}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.120.006853']
2004,32500650,Long-term health-related quality of life among men with prostate cancer in the Finnish randomized study of screening for prostate cancer.,"BACKGROUND


The long-term health-related quality of life (HRQOL) impacts of PCa screening have not been adequately evaluated. We aimed to compare the generic and disease-specific health-related quality of life (HRQOL) among men with prostate cancer in the screening arm with the control arm of the PSA-based prostate cancer screening trial in up to 15 years of follow-up.
MATERIALS AND METHODS


This study was conducted within population-based Finnish Randomized Study of Screening for Prostate Cancer (FinRSPC). During 1996-1999 80,458 men were randomized to the serum prostate-specific antigen (PSA) screening arm (SA, N = 32 000) and the control arm (CA, N = 48 458). Men in the screening arm were screened at 4-year intervals until 2007. HRQOL questionnaires were delivered to newly diagnosed prostate cancer patients in the screening and control arm 1996-2006 (N = 5128) at the time of diagnosis (baseline), at 3-month, 12-month and 5, 10, and 15-year follow-up. Validated UCLA Prostate Cancer Index (UCLA-PCI) and RAND 36-Item Health Survey were used for HRQOL assessment. The data were analyzed with a random effects model for repeated measures.
RESULTS


At baseline, men with prostate cancer in the screening arm reported better Sexual Function, as well as less Sexual and Urinary Bother. Long-term follow-up revealed slightly higher HRQOL scores in the screening arm in prostate cancer specific measures at 10-year post diagnosis, but the differences were statistically significant only in Urinary Bother (UCLA-PCI score 77.9; 95% CI 75.2 to 80.5 vs. 70.9; 95% CI 66.8 to 74.9 P = .005). The generic HRQOL scores were comparable between the trial arms. The overall differences in disease-specific or generic HRQOL scores by trial arm did not vary during the follow-up.
CONCLUSION


No major differences were observed in HRQOL in men with prostate cancer between the prostate cancer screening and control arms during five to 15-year follow-up.",2020,"Long-term follow-up revealed slightly higher HRQOL scores in the screening arm in prostate cancer specific measures at 10-year post diagnosis, but the differences were statistically significant only in Urinary Bother (UCLA-PCI score 77.9; 95% CI 75.2 to 80.5 vs. 70.9; 95% CI 66.8 to 74.9 P = .005).The generic HRQOL scores were comparable between the trial arms.","['Men in the screening arm were screened at 4-year intervals until 2007', 'newly diagnosed prostate cancer patients in the screening and control arm 1996-2006', 'population-based Finnish Randomized Study of Screening for Prostate Cancer (FinRSPC', 'men with prostate cancer in the Finnish randomized study of screening for prostate cancer', 'men with prostate cancer in the screening arm with the control arm of the PSA-based prostate cancer screening trial in up to 15\xa0years of follow-up', 'During 1996-1999 80,458 men']",['serum prostate-specific antigen (PSA) screening'],"['HRQOL questionnaires', 'Validated UCLA Prostate Cancer Index (UCLA-PCI) and RAND 36-Item Health Survey', 'Urinary Bother (UCLA-PCI score', 'HRQOL', 'HRQOL scores', 'generic HRQOL scores', 'disease-specific or generic HRQOL scores', 'generic and disease-specific health-related quality of life (HRQOL', 'Sexual Function']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0016134', 'cui_str': 'Finnish language'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}]",80458.0,0.0974762,"Long-term follow-up revealed slightly higher HRQOL scores in the screening arm in prostate cancer specific measures at 10-year post diagnosis, but the differences were statistically significant only in Urinary Bother (UCLA-PCI score 77.9; 95% CI 75.2 to 80.5 vs. 70.9; 95% CI 66.8 to 74.9 P = .005).The generic HRQOL scores were comparable between the trial arms.","[{'ForeName': 'Kirsi', 'Initials': 'K', 'LastName': 'Talala', 'Affiliation': 'Finnish Cancer Registry, Helsinki, Finland.'}, {'ForeName': 'Sirpa', 'Initials': 'S', 'LastName': 'Heinävaara', 'Affiliation': 'Finnish Cancer Registry, Helsinki, Finland.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Taari', 'Affiliation': 'Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Teuvo L J', 'Initials': 'TLJ', 'LastName': 'Tammela', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Kujala', 'Affiliation': 'Department of Pathology, Fimlab Laboratories, Tampere, Finland.'}, {'ForeName': 'Ulf-Håkan', 'Initials': 'UH', 'LastName': 'Stenman', 'Affiliation': 'Department of Clinical Chemistry and Hematology, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Nea', 'Initials': 'N', 'LastName': 'Malila', 'Affiliation': 'Finnish Cancer Registry, Helsinki, Finland.'}, {'ForeName': 'Anssi', 'Initials': 'A', 'LastName': 'Auvinen', 'Affiliation': 'Faculty of Social Sciences/Health Sciences, Tampere University, Tampere, Finland.'}]",Cancer medicine,['10.1002/cam4.3181']
2005,31830830,Effect of Blood Flow Restricted Resistance Exercise and Remote Ischemic Conditioning on Functional Capacity and Myocellular Adaptations in Patients With Heart Failure.,"BACKGROUND


Patients with congestive heart failure (CHF) have impaired functional capacity and inferior quality of life. The clinical manifestations are associated with structural and functional impairments in skeletal muscle, emphasizing a need for feasible rehabilitation strategies beyond optimal anticongestive medical treatment. We investigated whether low-load blood flow restricted resistance exercise (BFRRE) or remote ischemic conditioning (RIC) could improve functional capacity and quality of life in patients with CHF and stimulate skeletal muscle myofibrillar and mitochondrial adaptations.
METHODS


We randomized 36 patients with CHF to BFRRE, RIC, or nontreatment control. BFRRE and RIC were performed 3× per week for 6 weeks. Before and after intervention, muscle biopsies, tests of functional capacity, and quality of life assessments were performed. Deuterium oxide was administered throughout the intervention to measure cumulative RNA and subfraction protein synthesis. Changes in muscle fiber morphology and mitochondrial respiratory function were also assessed.
RESULTS


BFRRE improved 6-minute walk test by 39.0 m (CI, 7.0-71.1,  P =0.019) compared with control. BFRRE increased maximum isometric strength by 29.7 Nm (CI, 10.8-48.6,  P =0.003) compared with control. BFRRE improved quality of life by 5.4 points (CI, -0.04 to 10.9;  P =0.052) compared with control. BFRRE increased mitochondrial function by 19.1 pmol/s per milligram (CI, 7.3-30.8;  P =0.002) compared with control. RIC did not produce similar changes.
CONCLUSIONS


Our results demonstrate that BFRRE, but not RIC, improves functional capacity, quality of life, and muscle mitochondrial function. Our findings have clinical implications for rehabilitation of patients with CHF and provide new insights on the myopathy accompanying CHF.
CLINICAL TRIAL REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT03380663.",2019,"BFRRE improved quality of life by 5.4 points (CI, -0.04 to 10.9;  P =0.052) compared with control.","['36 patients with CHF to BFRRE, RIC, or nontreatment control', 'patients with CHF and stimulate skeletal muscle myofibrillar and mitochondrial adaptations', 'Patients with congestive heart failure (CHF', 'Patients With Heart Failure']","['Deuterium oxide', 'low-load blood flow restricted resistance exercise (BFRRE) or remote ischemic conditioning (RIC', 'Blood Flow Restricted Resistance Exercise and Remote Ischemic Conditioning']","['BFRRE increased mitochondrial function', 'BFRRE improved 6-minute walk test', 'BFRRE improved quality of life', 'muscle biopsies, tests of functional capacity, and quality of life assessments', 'functional capacity and quality of life', 'maximum isometric strength', 'BFRRE and RIC', 'functional capacity, quality of life, and muscle mitochondrial function', 'Functional Capacity and Myocellular Adaptations', 'muscle fiber morphology and mitochondrial respiratory function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0011745', 'cui_str': 'Deuterium oxide'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0185283', 'cui_str': 'Biopsy of muscle'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]",36.0,0.0478746,"BFRRE improved quality of life by 5.4 points (CI, -0.04 to 10.9;  P =0.052) compared with control.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Groennebaek', 'Affiliation': 'Section for Sports Science, Department of Public Health, Aarhus University, Aarhus, Denmark (T.G., P.S., J.W., C.R.C., K.V.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sieljacks', 'Affiliation': 'Section for Sports Science, Department of Public Health, Aarhus University, Aarhus, Denmark (T.G., P.S., J.W., C.R.C., K.V.).'}, {'ForeName': 'Roni', 'Initials': 'R', 'LastName': 'Nielsen', 'Affiliation': 'Department of Cardiology (R.N., K.P., N.R.J., M.R.S., H.E.B.), Aarhus University Hospital, Denmark.'}, {'ForeName': 'Kasper', 'Initials': 'K', 'LastName': 'Pryds', 'Affiliation': 'Department of Cardiology (R.N., K.P., N.R.J., M.R.S., H.E.B.), Aarhus University Hospital, Denmark.'}, {'ForeName': 'Nichlas R', 'Initials': 'NR', 'LastName': 'Jespersen', 'Affiliation': 'Department of Cardiology (R.N., K.P., N.R.J., M.R.S., H.E.B.), Aarhus University Hospital, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Section for Sports Science, Department of Public Health, Aarhus University, Aarhus, Denmark (T.G., P.S., J.W., C.R.C., K.V.).'}, {'ForeName': 'Caroline R', 'Initials': 'CR', 'LastName': 'Carlsen', 'Affiliation': 'Section for Sports Science, Department of Public Health, Aarhus University, Aarhus, Denmark (T.G., P.S., J.W., C.R.C., K.V.).'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Schmidt', 'Affiliation': 'Department of Cardiology (R.N., K.P., N.R.J., M.R.S., H.E.B.), Aarhus University Hospital, Denmark.'}, {'ForeName': 'Frank V', 'Initials': 'FV', 'LastName': 'de Paoli', 'Affiliation': 'Department of Biomedicine (F.V.d.P.), Aarhus University Hospital, Denmark.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Miller', 'Affiliation': 'Aging and Metabolism Research Program, Oklahoma Medical Research Foundation, Oklahoma City (B.F.M.).'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Vissing', 'Affiliation': 'Section for Sports Science, Department of Public Health, Aarhus University, Aarhus, Denmark (T.G., P.S., J.W., C.R.C., K.V.).'}, {'ForeName': 'Hans Erik', 'Initials': 'HE', 'LastName': 'Bøtker', 'Affiliation': 'Department of Cardiology (R.N., K.P., N.R.J., M.R.S., H.E.B.), Aarhus University Hospital, Denmark.'}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.119.006427']
2006,32502882,Continuing versus suspending angiotensin-converting enzyme inhibitors and angiotensin receptor blockers: Impact on adverse outcomes in hospitalized patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)--The BRACE CORONA Trial.,"Angiotensin-converting enzyme-2 (ACE2) expression may increase due to upregulation in patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs). Because renin-angiotensin system blockers increase levels of ACE2, a protein that facilitates coronavirus entry into cells, there is concern that these drugs could increase the risk of developing a severe and fatal form of COVID-19. The impact of discontinuing ACEI and ARBs in patients with COVID-19 remains uncertain. DESIGN: BRACE CORONA is a pragmatic, multicenter, randomized, phase IV, clinical trial that aims to enroll around 500 participants at 34 sites in Brazil. Participants will be identified from an ongoing national registry of suspected and confirmed cases of COVID-19. Eligible patients using renin-angiotensin system blockers (ACEI/ARBs) with a confirmed diagnosis of COVID-19 will be randomized to a strategy of continued ACEI/ARB treatment versus temporary discontinuation for 30 days. The primary outcome is the median days alive and out of the hospital at 30 days. Secondary outcomes include progression of COVID-19 disease, all-cause mortality, death from cardiovascular causes, myocardial infarction, stroke, transient ischemic attack, new or worsening heart failure, myocarditis, pericarditis, arrhythmias, thromboembolic events, hypertensive crisis, respiratory failure, hemodynamic decompensation, sepsis, renal failure, and troponin, B-type natriuretic peptide (BNP), N-terminal-proBNP, and D-dimer levels. SUMMARY: BRACE CORONA will evaluate whether the strategy of continued ACEI/ARB therapy compared with temporary discontinuation of these drugs impacts clinical outcomes among patients with COVID-19.",2020,Angiotensin-converting enzyme-2 (ACE2) expression may increase due to upregulation in patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs).,"['patients with COVID-19', 'patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs', '500 participants at 34 sites in Brazil', 'hospitalized patients with severe acute respiratory syndrome coronavirus 2', 'patients with COVID-19 remains uncertain', 'Eligible patients using renin-angiotensin system blockers (ACEI/ARBs) with a confirmed diagnosis of COVID-19']","['suspending angiotensin-converting enzyme inhibitors and angiotensin receptor blockers', 'Angiotensin-converting enzyme-2 (ACE2']","['progression of COVID-19 disease, all-cause mortality, death from cardiovascular causes, myocardial infarction, stroke, transient ischemic attack, new or worsening heart failure, myocarditis, pericarditis, arrhythmias, thromboembolic events, hypertensive crisis, respiratory failure, hemodynamic decompensation, sepsis, renal failure, and troponin, B-type natriuretic peptide (BNP), N-terminal-proBNP, and D-dimer levels', 'median days alive and out of the hospital at 30 days']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0038959', 'cui_str': 'Suspending Agents'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0960880', 'cui_str': 'angiotensin converting enzyme 2'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0027059', 'cui_str': 'Myocarditis'}, {'cui': 'C0031046', 'cui_str': 'Pericarditis'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0020546', 'cui_str': 'Hypertensive crisis'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0231187', 'cui_str': 'Decompensation'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",500.0,0.143314,Angiotensin-converting enzyme-2 (ACE2) expression may increase due to upregulation in patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs).,"[{'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA; Brazilian Clinical Research Institute, São Paulo, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil. Electronic address: renato.lopes@dm.duke.edu.""}, {'ForeName': 'Ariane Vieira Scarlatelli', 'Initials': 'AVS', 'LastName': 'Macedo', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil; Santa Casa de São Paulo, São Paulo, Brazil.""}, {'ForeName': 'Pedro Gabriel Melo', 'Initials': 'PGM', 'LastName': 'de Barros E Silva', 'Affiliation': 'Brazilian Clinical Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Renata Junqueira', 'Initials': 'RJ', 'LastName': 'Moll-Bernardes', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Feldman', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil.""}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': ""D'Andréa Saba Arruda"", 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil.""}, {'ForeName': 'Andrea Silvestre', 'Initials': 'AS', 'LastName': 'de Souza', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil; Federal University of Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil.""}, {'ForeName': 'Denilson Campos', 'Initials': 'DC', 'LastName': 'de Albuquerque', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Universidade do Estado do Rio de Janeiro (UERJ), Rio de Janeiro, Brazil.""}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Mazza', 'Affiliation': 'Brazilian Clinical Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Mayara Fraga', 'Initials': 'MF', 'LastName': 'Santos', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Natalia Zerbinatti', 'Initials': 'NZ', 'LastName': 'Salvador', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Gibson', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Olga Ferreira', 'Initials': 'OF', 'LastName': 'de Souza', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.05.002']
2007,32502908,Effects of 1 mA and 2 mA transcranial direct current stimulation on working memory performance in healthy participants.,"Anodal transcranial current stimulation (tDCS) to the left dorsolateral prefrontal cortex (DLPFC) has been shown to enhance working memory (WM) in neuropsychiatric patients. In healthy populations, however, tDCS obtains inconclusive results, mostly due to heterogeneous study and stimulation protocols. Here, we approached these issues by investigating effects of tDCS intensity on simultaneous WM performance with three cognitive loads by directly comparing findings of two double-blind, cross-over, sham-controlled experiments. TDCS was administrated to the left DLPFC at intensity of 1 mA (Experiment 1) or 2 mA (Experiment 2), while participants completed a verbal n-back paradigm (1-, 2-, 3-back). Analysis showed no overall effects of tDCS on WM, but a significant interaction with cognitive load. The present study suggests that cognitive load rather than tDCS intensity could be a decisive factor for effects on WM. Moreover, it emphasizes the need of thorough investigation on study parameters to develop more efficient stimulation protocols.",2020,"Analysis showed no overall effects of tDCS on WM, but a significant interaction with cognitive load.","['healthy participants', 'neuropsychiatric patients']","['1\xa0mA and 2\xa0mA transcranial direct current stimulation', 'TDCS', 'Anodal transcranial current stimulation (tDCS']",['working memory performance'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1172076', 'cui_str': '1-(1-phenylethyl)-2-methyleneaziridine'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",,0.0450811,"Analysis showed no overall effects of tDCS on WM, but a significant interaction with cognitive load.","[{'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Papazova', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany. Electronic address: Irina.papazova@med.uni-muenchen.de.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Strube', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Wienert', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Henning', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Schwippel', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Neurophysiology & Interventional Neuropsychiatry, University of Tübingen, Germany.'}, {'ForeName': 'Andreas J', 'Initials': 'AJ', 'LastName': 'Fallgatter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Neurophysiology & Interventional Neuropsychiatry, University of Tübingen, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Padberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Falkai', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Plewnia', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Neurophysiology & Interventional Neuropsychiatry, University of Tübingen, Germany.'}, {'ForeName': 'Alkomiet', 'Initials': 'A', 'LastName': 'Hasan', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany; Department of Psychiatry, Psychotherapy and Psychosomatics, BKH Augsburg, Medical Faculty, University of Augsburg, Germany.'}]",Consciousness and cognition,['10.1016/j.concog.2020.102959']
2008,32502923,"A phase III, randomized, double-blind, multicenter study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB8 (proposed bevacizumab biosimilar) and reference bevacizumab in patients with metastatic or recurrent nonsquamous non-small cell lung cancer.","OBJECTIVES


Efficacy, safety, pharmacokinetics (PK), and immunogenicity of the biosimilar candidate SB8 was compared to its reference product bevacizumab (BEV) in patients with metastatic or recurrent nonsquamous non-small cell lung cancer.
METHODS


Patients were randomized (1:1) in a phase III, double-blind study to receive intravenous SB8 or BEV 15 mg/kg with paclitaxel/carboplatin every 3 weeks for 24 weeks, followed by SB8 or BEV maintenance monotherapy. The primary endpoint was best overall response rate (ORR) by 24 weeks. Secondary endpoints included survival outcomes, safety, PK, and immunogenicity.
RESULTS


763 patients (SB8, n = 379; BEV, n = 384) were randomized; baseline characteristics were well balanced. Best ORR in the FAS was 47.6% and 42.8%, and best ORR in the PPS was 50.1% and 44.8% for SB8 and BEV, respectively. The risk ratio of best ORR was 1.11 (90% CI, 0.975-1.269), and the risk difference in best ORR was 5.3% (95% CI, -2.2%-12.9%). Median survival outcomes were comparable between SB8 and BEV: progression-free survival was 8.50 vs 7.90 months, respectively (HR [95% CI], 0.99 [0.83-1.18]; p = 0.9338); overall survival was 14.90 vs 15.80 months, respectively (HR [95% CI], 1.03 [0.83-1.28]; p = 0.7713); and duration of response was 7.70 vs 7.00 months, respectively (HR [95% CI], 1.05 [0.81-1.37]; p = 0.6928). Severity and incidence of treatment-emergent adverse events, PK, and immunogenicity were comparable between SB8 and BEV.
CONCLUSION


This study demonstrated equivalence between SB8 and BEV in terms of best ORR risk ratio, with comparable safety, PK, and immunogenicity.",2020,"Severity and incidence of treatment-emergent adverse events, PK, and immunogenicity were comparable between SB8 and BEV.
","['763 patients (SB8, n\u2009=\u2009379; BEV, n\u2009=\u2009384', 'Patients', 'patients with metastatic or recurrent nonsquamous non-small cell lung cancer']","['paclitaxel/carboplatin', 'bevacizumab (BEV', 'bevacizumab', 'intravenous SB8 or BEV 15']","['duration of response', 'Efficacy, safety, pharmacokinetics (PK), and immunogenicity', 'risk ratio of best ORR', 'Median survival outcomes', 'safety, PK, and immunogenicity', 'overall response rate (ORR', 'overall survival', 'Severity and incidence of treatment-emergent adverse events, PK, and immunogenicity', 'FAS', 'efficacy, safety, pharmacokinetics, and immunogenicity', 'SB8 and BEV: progression-free survival', 'survival outcomes, safety, PK, and immunogenicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",763.0,0.560036,"Severity and incidence of treatment-emergent adverse events, PK, and immunogenicity were comparable between SB8 and BEV.
","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'Department of Thoracic Oncology, Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Lung Clinic, Woehrendamm 80, 22927 Grosshansdorf, Germany. Electronic address: m.reck@lungenclinic.de.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Luft', 'Affiliation': 'Department of Thoracic Surgery, Leningrad Regional Clinical Hospital, St. Petersburg, Russian Federation. Electronic address: alexander_luft@mail.ru.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Bondarenko', 'Affiliation': 'Oncology and Medical Radiology Department, Dnipropetrovsk Medical Academy, Dnipro, Ukraine. Electronic address: oncology@dsma.dp.ua.'}, {'ForeName': 'Serhii', 'Initials': 'S', 'LastName': 'Shevnia', 'Affiliation': 'Department of Chemotherapy, Podillia Regional Oncology Center, Vinnytsia, Ukraine. Electronic address: shevnia1969@gmail.com.'}, {'ForeName': 'Dmytro', 'Initials': 'D', 'LastName': 'Trukhin', 'Affiliation': 'Oncology Department, Odessa Regional Oncology Center, Odessa, Ukraine. Electronic address: dtrukhin39@gmail.com.'}, {'ForeName': 'Nadezhda V', 'Initials': 'NV', 'LastName': 'Kovalenko', 'Affiliation': 'Oncology, Volgograd Regional Clinical Oncology Dispensary, Volgograd, Russian Federation. Electronic address: kovalenkost@yandex.ru.'}, {'ForeName': 'Kakha', 'Initials': 'K', 'LastName': 'Vacharadze', 'Affiliation': 'Department of Phthisiatry, Research Institute of Clinical Medicine, Tbilisi, Georgia. Electronic address: kakhavacharadze@yahoo.com.'}, {'ForeName': 'Fülöp', 'Initials': 'F', 'LastName': 'Andrea', 'Affiliation': 'Department of Pulmonary Class and Bronchology, Országos Korányi TBC és Pulmonológiai Intézet, Budapest, Hungary. Electronic address: afulop64@gmail.com.'}, {'ForeName': 'Anatoliy', 'Initials': 'A', 'LastName': 'Hontsa', 'Affiliation': 'Day Staing Department, Chernivtsi Regional Oncology Center, Chernivtsi, Ukraine. Electronic address: anatoliyhontsa@gmail.com.'}, {'ForeName': 'Jihye', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': 'Biometrics, Samsung Bioepis Co., Ltd., Suwon, Republic of Korea. Electronic address: jihye24.choi@samsung.com.'}, {'ForeName': 'Donghoon', 'Initials': 'D', 'LastName': 'Shin', 'Affiliation': 'Clinical Development, Samsung Bioepis Co., Ltd., Suwon, Republic of Korea. Electronic address: dh01.shin@samsung.com.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.05.027']
2009,32502940,"The EndoPredict score predicts response to neoadjuvant chemotherapy and neoendocrine therapy in hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer patients from the ABCSG-34 trial.","BACKGROUND


Neoadjuvant chemotherapy (NaCT) and neoadjuvant endocrine therapy (NET) can reduce pre-operative tumour burden in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer. This prospective translational study assessed the ability of a 12-gene molecular score (MS; EndoPredict®) to predict response to NaCT or NET within the ABCSG-34 trial.
PATIENTS AND METHODS


Hormone receptor (HR)-positive, HER2-negative samples from patients in the ABCSG-34 randomized phase II trial were selected and EndoPredict testing was performed to generate a 12-gene MS. ABCSG-34 patients were assigned to receive either NaCT or NET based on menopausal status, HR expression, grade and Ki67. Response was measured by residual cancer burden (RCB).
RESULTS


Patients selected for NaCT generally had high-risk disease by 12-gene MS (125/134), while slightly more patients treated with NET had low-risk disease (44/83). Low-risk NaCT-treated and high-risk NET-treated tumours responded poorly (NPV 100% [95% CI 66.4%-100%] and NPV 92.3% [95% CI 79.1%-98.4%], respectively]. The 12-gene MS significantly predicted treatment response for NaCT (AUC 0.736 [95% CI 0.63-0.84]) and NET (AUC 0.726 [95% CI 0.60-0.85]).
CONCLUSIONS


The 12-gene MS predicted RCB after treatment with neoadjuvant therapies for patients with HR-positive, HER2-negative early-stage breast cancer. Tumours with low MS were unlikely to benefit from NaCT, whereas a high MS predicted resistance to NET. This additional biologic information can aid personalized treatment selection in daily practice and builds a strong rationale to use EndoPredict in biomarker-driven studies in the neoadjuvant setting.",2020,"The 12-gene MS significantly predicted treatment response for NaCT (AUC 0.736 [95% CI 0.63-0.84]) and NET (AUC 0.726 [95% CI 0.60-0.85]).
","['patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer', 'Hormone receptor (HR)-positive, HER2-negative samples from patients in the ABCSG-34 randomized phase', 'patients with HR-positive, HER2-negative early-stage breast cancer']","['neoadjuvant chemotherapy and neoendocrine therapy', 'NaCT', 'Neoadjuvant chemotherapy (NaCT) and neoadjuvant endocrine therapy (NET', 'NaCT or NET']","['residual cancer burden (RCB', 'high-risk disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034804', 'cui_str': 'Estrogen receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]","[{'cui': 'C0242594', 'cui_str': 'Residual Cancer'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.0845297,"The 12-gene MS significantly predicted treatment response for NaCT (AUC 0.736 [95% CI 0.63-0.84]) and NET (AUC 0.726 [95% CI 0.60-0.85]).
","[{'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Dubsky', 'Affiliation': 'Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Breast Center St. Anna, Lucerne, Switzerland. Electronic address: peter.dubsky@hirslanden.ch.'}, {'ForeName': 'Christian F', 'Initials': 'CF', 'LastName': 'Singer', 'Affiliation': 'Department of Gynecology, Breast Health Center and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Egle', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Wette', 'Affiliation': 'Breast Center, Brustzentrum Kärnten, St. Veit, Austria.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Petru', 'Affiliation': 'Department of Gynecology and Obstetrics, Medical University Graz, Graz, Austria.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Balic', 'Affiliation': 'Department of Internal Medicine, Division of Oncology, Medical University Graz, Graz, Austria.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Pichler', 'Affiliation': 'Department of Hemato-Oncology, LKH Hochsteiermark-Leoben, Leoben, Austria.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'Department of Internal Medicine III with Hematology, Medical Oncology, Hemostaseology, Infectious Disease, Rheumatology, Oncologic Center, Laboratory for Immunological and Molecular Cancer Research, Paracelsus Medical University, Salzburg Cancer Research Institute-CCCIT, Cancer Cluster Salzburg, Salzburg, Austria.'}, {'ForeName': 'Andreas L', 'Initials': 'AL', 'LastName': 'Petzer', 'Affiliation': 'Internal Medicine I, Hematology with Stem Cell Transplantation, Hemostaseology and Medical Oncology, Ordensklinkum Linz Barmherzige Schwestern, Elisabethinen, Linz, Austria.'}, {'ForeName': 'Zsuzsanna', 'Initials': 'Z', 'LastName': 'Bago-Horvath', 'Affiliation': 'Department of Pathology, Breast Health Center and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Fesl', 'Affiliation': 'Department of Statistics, Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Meek', 'Affiliation': 'Myriad Genetics, Inc., Salt Lake City, UT, USA.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Kronenwett', 'Affiliation': 'Myriad International GmbH, Cologne, Germany.'}, {'ForeName': 'Margaretha', 'Initials': 'M', 'LastName': 'Rudas', 'Affiliation': 'Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gnant', 'Affiliation': 'Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Filipits', 'Affiliation': 'Institute of Cancer Research, Department of Medicine I, Breast Health Center and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.04.020']
2010,32512184,"Accelerated iTBS treatment applied to the left DLPFC in depressed patients results in a rapid volume increase in the left hippocampal dentate gyrus, not driven by brain perfusion.","BACKGROUND


Accelerated intermittent Theta Burst Stimulation (aiTBS) has been shown to be an effective antidepressant treatment. Although neurobiological changes shortly after this intervention have been reported, whether aiTBS results in structural brain changes must still be determined. Furthermore, it possible that rapid volumetric changes are driven by factors other than neurotrophic processes.
OBJECTIVES


We examined whether possible grey matter volumetric (GMV) increases after aiTBS treatment could be driven by increased brain perfusion, measured by Arterial Spin Labeling (ASL).
METHODS


46 treatment-resistant depressed patients were randomized to receive 20 sessions of active or sham iTBS applied to the left dorsolateral prefrontal cortex. All sessions were delivered over 4 days at 5 sessions per day (trial registration: http://clinicaltrials.gov/show/NCT01832805). Patients were scanned the day before starting stimulation and three days after aiTBS.
RESULTS


There was a significant cluster of increased left hippocampal GMV in the dentate gyrus related to HRSD changes after active aiTBS, but not after sham stimulation. These GMV increases became more pronounced when accounting for changes in cerebral perfusion.
CONCLUSIONS


Active, but not sham, aiTBS, resulted in acute volumetric changes in parts of the left dentate gyrus, suggesting a connection with adult neurogenesis. Furthermore, taking cerebral perfusion measurements into account impacts on detection of the GMV changes. Whether these hippocampal volumetric changes produced by active aiTBS are necessary for long-term clinical improvement remains to be determined.",2020,"There was a significant cluster of increased left hippocampal GMV in the dentate gyrus related to HRSD changes after active aiTBS, but not after sham stimulation.",['46 treatment-resistant depressed patients'],"['Accelerated intermittent Theta Burst Stimulation (aiTBS', '20 sessions of active or sham iTBS']","['Arterial Spin Labeling (ASL', 'left hippocampal GMV']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}]",46.0,0.102893,"There was a significant cluster of increased left hippocampal GMV in the dentate gyrus related to HRSD changes after active aiTBS, but not after sham stimulation.","[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Baeken', 'Affiliation': 'Ghent University, Department of Psychiatry and Medical Psychology, Ghent Experimental Psychiatry (GHEP) Lab, Ghent, Belgium; Vrije Universiteit Brussel (VUB), Department of Psychiatry, Universitair Ziekenhuis Brussel (UZBrussel), Laarbeeklaan 101, 1090, Brussels, Belgium; Eindhoven University of Technology, Department of Electrical Engineering, Eindhoven, the Netherlands.'}, {'ForeName': 'GuoRong', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': 'Key Laboratory of Cognition and Personality, Faculty of Psychology, Southwest University, Chongqing, China. Electronic address: guorongwu@swu.edu.cn.'}, {'ForeName': 'Harold A', 'Initials': 'HA', 'LastName': 'Sackeim', 'Affiliation': 'Columbia University, Department of Psychiatry, New York, NY, USA; Columbia University, Department of Radiology, New York, NY, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.05.015']
2011,32512262,Intensive therapy alleviates subclinical synovitis on ultrasound and disease activity and reduces flare in rheumatoid arthritis patients who have achieved clinical target - a randomized controlled trial.,"OBJECTIVE


Whether intensive therapy can alleviate subclinical synovitis and reduce flare in rheumatoid arthritis (RA) patients in clinical remission remains unclear. We designed a 1-year open-labelled, randomized controlled clinical trial to elucidate this question.
METHODS


RA patients in clinical remission/low disease activity (defined by DAS28-CRP≤ 3.2), however with subclinical synovitis on ultrasound [power Doppler (PD)≥1 and/or gray scale (GS)≥2] were randomized to receive maintenance or intensive treatment at a ratio of 1:1. The primary outcome was the rate of RA relapse (defined by DAS28-CRP>3.2 and an increase≥0.6). The secondary outcomes were changes of PD and GS scores, and clinical disease activity at each visit from baseline.
RESULTS


108 patients with 54 in each group were enrolled. During 1-year follow-up, the relapse rate was significantly higher in maintenance group than in intensive group, regardless of all enrolled patients or those in remission [24.1% (13/54) vs. 9.1% (5/54), p=0.039; 26.2% (11/42) vs. 5.3% (2/38), p=0.026, respectively]. Although GS and PD scores were decreased at 12 months in both groups, the decline was more remarkable in intensive group than in maintenance group. The improvement of clinical disease activity score was only observed in intensive group, not maintenance group. Adverse events were comparable between two groups. Abnormal liver function tests were observed in 24 (22%) patients with 16 from intensive group.
CONCLUSION


Intensive therapy can alleviate subclinical synovitis on ultrasound and clinical disease activity, and prevent relapse in RA patients who have achieved clinical remission or low disease activity, with comparable safety profiles to maintenance therapy.
REGISTRATION NUMBER


ChiCTR2000029279.",2020,"During 1-year follow-up, the relapse rate was significantly higher in maintenance group than in intensive group, regardless of all enrolled patients or those in remission [24.1% (13/54) vs. 9.1% (5/54), p=0.039; 26.2% (11/42) vs. 5.3% (2/38), p=0.026, respectively].","['rheumatoid arthritis patients who have achieved clinical target ', '24 (22%) patients with 16 from intensive group', 'RA patients in clinical remission/low disease activity (defined by DAS28-CRP≤ 3.2), however with subclinical synovitis on ultrasound [power Doppler (PD)≥1 and/or gray scale (GS)≥2', '108 patients with 54 in each group were enrolled', 'rheumatoid arthritis']","['Intensive therapy', 'intensive therapy']","['rate of RA relapse', 'Adverse events', 'changes of PD and GS scores, and clinical disease activity', 'GS and PD scores', 'relapse rate', 'clinical disease activity score', 'Abnormal liver function tests']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0039103', 'cui_str': 'Synovitis'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0556636', 'cui_str': 'Gy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4517530', 'cui_str': '108'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0556636', 'cui_str': 'Gy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0151766', 'cui_str': 'Liver function tests abnormal'}]",108.0,0.101084,"During 1-year follow-up, the relapse rate was significantly higher in maintenance group than in intensive group, regardless of all enrolled patients or those in remission [24.1% (13/54) vs. 9.1% (5/54), p=0.039; 26.2% (11/42) vs. 5.3% (2/38), p=0.026, respectively].","[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Geng', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Xuerong', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Lanlan', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Zhibo', 'Initials': 'Z', 'LastName': 'Song', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Zhuoli', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China. Electronic address: zhuoli.zhang@126.com.'}]",Seminars in arthritis and rheumatism,['10.1016/j.semarthrit.2020.05.014']
2012,32516282,"Baloxavir Marboxil Single-dose Treatment in Influenza-infected Children: A Randomized, Double-blind, Active Controlled Phase 3 Safety and Efficacy Trial (miniSTONE-2).","BACKGROUND


Baloxavir marboxil (baloxavir) is a novel, cap-dependent endonuclease inhibitor that has previously demonstrated efficacy in the treatment of influenza in adults and adolescents. We assessed the safety and efficacy of baloxavir in otherwise healthy children with acute influenza.
METHODS


MiniSTONE-2 (Clinicaltrials.gov: NCT03629184) was a double-blind, randomized, active controlled trial enrolling children 1-<12 years old with a clinical diagnosis of influenza. Children were randomized 2:1 to receive either a single dose of oral baloxavir or oral oseltamivir twice daily for 5 days. The primary endpoint was incidence, severity and timing of adverse events (AEs); efficacy was a secondary endpoint.
RESULTS


In total, 173 children were randomized and dosed, 115 to the baloxavir group and 58 to the oseltamivir group. Characteristics of participants were similar between treatment groups. Overall, 122 AEs were reported in 84 (48.6%) children. Incidence of AEs was similar between baloxavir and oseltamivir groups (46.1% vs. 53.4%, respectively). The most common AEs were gastrointestinal (vomiting/diarrhea) in both groups [baloxavir: 12 children (10.4%); oseltamivir: 10 children (17.2%)]. No deaths, serious AEs or hospitalizations were reported. Median time (95% confidence interval) to alleviation of signs and symptoms of influenza was similar between groups: 138.1 (116.6-163.2) hours with baloxavir versus 150.0 (115.0-165.7) hours with oseltamivir.
CONCLUSIONS


Oral baloxavir is well tolerated and effective at alleviating symptoms in otherwise healthy children with acute influenza. Baloxavir provides a new therapeutic option with a simple oral dosing regimen.",2020,"Median time (95% confidence interval) to alleviation of signs and symptoms of influenza was similar between groups: 138.1 (116.6-163.2) hours with baloxavir versus 150.0 (115.0-165.7) hours with oseltamivir.
","['otherwise healthy children with acute influenza', 'children 1-<12 years old with a clinical diagnosis of influenza', 'adults and adolescents', '12 children (10.4', 'Influenza-infected Children', '10 children (17.2', '173 children were randomized and dosed, 115 to the baloxavir group and 58 to the oseltamivir group']","['oseltamivir', 'Baloxavir', 'baloxavir', 'Baloxavir Marboxil Single-dose Treatment', 'oral baloxavir or oral oseltamivir', 'Baloxavir marboxil (baloxavir']","['alleviation of signs and symptoms of influenza', 'incidence, severity and timing of adverse events (AEs); efficacy', 'No deaths, serious AEs or hospitalizations', 'safety and efficacy', 'Incidence of AEs', 'Median time', 'gastrointestinal (vomiting/diarrhea']","[{'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C5191376', 'cui_str': '10.4'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C4688747', 'cui_str': 'Baloxavir marboxil'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}]","[{'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C4734224', 'cui_str': 'baloxavir'}, {'cui': 'C4688747', 'cui_str': 'Baloxavir marboxil'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",173.0,0.517593,"Median time (95% confidence interval) to alleviation of signs and symptoms of influenza was similar between groups: 138.1 (116.6-163.2) hours with baloxavir versus 150.0 (115.0-165.7) hours with oseltamivir.
","[{'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Baker', 'Affiliation': 'From the Clinical Research Prime, Idaho Falls, Idaho.'}, {'ForeName': 'Stanley L', 'Initials': 'SL', 'LastName': 'Block', 'Affiliation': 'Kentucky Pediatric and Adult Research Inc., Bardstown, Kentucky.'}, {'ForeName': 'Balpreet', 'Initials': 'B', 'LastName': 'Matharu', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Welwyn Garden City, Hertfordshire, United Kingdom.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Burleigh Macutkiewicz', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Welwyn Garden City, Hertfordshire, United Kingdom.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Wildum', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Dimonaco', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Welwyn Garden City, Hertfordshire, United Kingdom.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Collinson', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Welwyn Garden City, Hertfordshire, United Kingdom.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Clinch', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Welwyn Garden City, Hertfordshire, United Kingdom.'}, {'ForeName': 'Pedro A', 'Initials': 'PA', 'LastName': 'Piedra', 'Affiliation': 'Baylor College of Medicine, Houston, Texas.'}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000002747']
2013,32521250,"Efficacy and safety of TS-121, a novel vasopressin V 1B  receptor antagonist, as adjunctive treatment for patients with major depressive disorder: A randomized, double-blind, placebo-controlled study.","Vasopressin 1B (V 1B ) receptor has a pivotal role in the regulation of the hypothalamus-adrenal-pituitary axis, and V 1B  receptor antagonists have shown efficacy in a number of preclinical models of depression. The efficacy and safety of, TS-121 (active ingredient: THY1773), a novel V 1B  receptor antagonist, was investigated in patients with major depressive disorder (MDD) who had an inadequate response to current antidepressant therapy. In a randomized, double-blind, placebo-controlled phase 2 study, 51 MDD patients (43 of whom completed the study) were randomly assigned to either TS-121 10 mg, 50 mg or placebo for 6 weeks treatment period. The primary endpoint was change from baseline on the Montgomery-Åsberg Depression Rating Scale (MADRS) score at week 6. The study was conducted from Jul 2017 to Dec 2018. The changes from baseline in MADRS score at week 6 (Least Square Mean [95% Confidence interval] were: TS-121 10 mg (-9.0 [-13.9, -4.1]), TS-121 50 mg (-9.0 [-13.4, -4.5]), and placebo (-6.4 [-10.7, -2.2]). TS-121 groups showed greater numerical reductions in MADRS score change from baseline compared to placebo, though these reductions did not achieve statistical significance. Similar trends of numerically greater improvements in TS-121 groups were observed across secondary endpoints. Higher baseline urinary and hair cortisol levels were associated with a greater separation between TS-121 groups and the placebo group in the primary endpoint. These findings, combined with favorable safety and tolerability, warrant further investigation of TS-121 in an adequately powered study in patients with MDD.",2020,Higher baseline urinary and hair cortisol levels were associated with a greater separation between TS-121 groups and the placebo group in the primary endpoint.,"['51 MDD patients (43 of whom completed the study', 'patients with MDD', 'patients with major depressive disorder', 'patients with major depressive disorder (MDD) who had an inadequate response to current antidepressant therapy', 'Jul 2017 to Dec 2018']","['TS-121, a novel vasopressin V 1B  receptor antagonist', 'Vasopressin 1B (V 1B ) receptor', 'TS-121', 'TS-121 50\xa0mg', 'TS-121 10\xa0mg, 50\xa0mg or placebo', 'placebo']","['MADRS score', 'Montgomery-Åsberg Depression Rating Scale (MADRS) score', 'MADRS score change', 'Higher baseline urinary and hair cortisol levels']","[{'cui': 'C1269683', 'cui_str': 'Major depressive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1096649', 'cui_str': 'Antidepressant therapy'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}]",51.0,0.556683,Higher baseline urinary and hair cortisol levels were associated with a greater separation between TS-121 groups and the placebo group in the primary endpoint.,"[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Kamiya', 'Affiliation': 'Taisho Pharmaceutical R&D Inc., 350 Mount Kemble Avenue, Morristown, NJ, 07960, USA. Electronic address: ma-kamiya@taisho.co.jp.'}, {'ForeName': 'Helene D', 'Initials': 'HD', 'LastName': 'Sabia', 'Affiliation': 'Taisho Pharmaceutical R&D Inc., 350 Mount Kemble Avenue, Morristown, NJ, 07960, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Marella', 'Affiliation': 'Taisho Pharmaceutical R&D Inc., 350 Mount Kemble Avenue, Morristown, NJ, 07960, USA.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital, 55 Fruit Street, Bulfinch 351, Boston, MA, 02114, USA.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Nemeroff', 'Affiliation': 'University of Texas Dell Medical School in Austin, 1601 Trinity Street, Stop Z0600, Office HDB 4.112, Austin, TX, 78712, USA.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Umeuchi', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd., Development Headquarters, 3-24-1 Takada, Toshima-ku, Tokyo, 170-8633, Japan.'}, {'ForeName': 'Michihiko', 'Initials': 'M', 'LastName': 'Iijima', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd., Research Headquarters, 1-403 Yoshino-cho, Kita-ku, Saitama, Saitama, 331-9530, Japan.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Chaki', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd., Research Headquarters, 1-403 Yoshino-cho, Kita-ku, Saitama, Saitama, 331-9530, Japan.'}, {'ForeName': 'Izumi', 'Initials': 'I', 'LastName': 'Nishino', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd., Development Headquarters, 3-24-1 Takada, Toshima-ku, Tokyo, 170-8633, Japan.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.05.017']
2014,32522422,Feasibility and impact of Fit & Strong! Program in Portuguese older adults with osteoarthritis: A pilot randomized controlled trial.,"This pilot study used a small randomized trial to examine the feasibility and the impact of an 8-week multicomponent program among Portuguese older adults with osteoarthritis. Participants were identified from the electronic registers from three primary healthcare centers. Thirty-one older adults (50+ years) with osteoarthritis were randomly assigned to experimental (n= 23) and control conditions (n= 8). Acceptance, attendance and retention rates were measured. The effect of the program on physical performance, osteoarthritis symptomatology (pain and stiffness), functionality, physical activity, depression, anxiety and fear of movement were assessed at baseline, posttest, and 4-months. The acceptance rate was 34%, and 90.4% attended all sessions of the program. The posttest retention rate in experimental group was 69.6% and 100% in control group. Findings demonstrated benefits of the Program on physical performance, function, anxiety, and fear of movement among participants. In the future, it will be important to improve the acceptance rate, however, the high attendance rate and observed effects indicate that the program is an attractive and effective intervention for Portuguese older adults with osteoarthritis.",2020,"The effect of the program on physical performance, osteoarthritis symptomatology (pain and stiffness), functionality, physical activity, depression, anxiety and fear of movement were assessed at baseline, posttest, and 4-months.","['Thirty-one older adults (50+ years) with osteoarthritis', 'Portuguese older adults with osteoarthritis', 'Participants were identified from the electronic registers from three primary healthcare centers']","['multicomponent program', 'Fit & Strong']","['acceptance rate', 'posttest retention rate', 'physical performance, function, anxiety, and fear of movement', 'physical performance, osteoarthritis symptomatology (pain and stiffness), functionality, physical activity, depression, anxiety and fear of movement', 'Acceptance, attendance and retention rates']","[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0032730', 'cui_str': 'Portuguese'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0442821', 'cui_str': 'Strong'}]","[{'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0424139', 'cui_str': 'Anxiety and fear'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]",31.0,0.0263707,"The effect of the program on physical performance, osteoarthritis symptomatology (pain and stiffness), functionality, physical activity, depression, anxiety and fear of movement were assessed at baseline, posttest, and 4-months.","[{'ForeName': 'Natália', 'Initials': 'N', 'LastName': 'Duarte', 'Affiliation': 'ICBAS, CINTESIS, University of Porto, Rua Jorge Viterbo Ferreira, 228, 4050-313 Porto, Portugal. Electronic address: nataliascduarte@gmail.com.'}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Santos', 'Affiliation': 'University of Porto, USF Argoncilhe, Portugal. Electronic address: catarinaalmeidasantos@gmail.com.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Hughes', 'Affiliation': 'Community Health Sciences, School of Public Health, Center for Research on Health and Aging, Institute for Health Research and Policy, University of Illinois at Chicago (MC 275), 345 Westside Research Office Bldg., 1747 West Roosevelt Road, Chicago, IL 60608. Electronic address: shughes@uic.edu.'}, {'ForeName': 'Constança', 'Initials': 'C', 'LastName': 'Paúl', 'Affiliation': 'ICBAS, CINTESIS, University of Porto, Rua Jorge Viterbo Ferreira, 228, 4050-313 Porto, Portugal. Electronic address: paul@icbas.up.pt.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2020.04.005']
2015,32522498,Randomized phase 2 trial and open-label extension of domagrozumab in Duchenne muscular dystrophy.,"We report results from a phase 2, randomized, double-blind, 2-period trial (48 weeks each) of domagrozumab and its open-label extension in patients with Duchenne muscular dystrophy (DMD). Of 120 ambulatory boys (aged 6 to <16 years) with DMD, 80 were treated with multiple ascending doses (5, 20, and 40 mg/kg) of domagrozumab and 40 treated with placebo. The primary endpoints were safety and mean change in 4-stair climb (4SC) time at week 49. Secondary endpoints included other functional tests, pharmacokinetics, and pharmacodynamics. Mean (SD) age was 8.4 (1.7) and 9.3 (2.3) years in domagrozumab- and placebo-treated patients, respectively. Difference in mean (95% CI) change from baseline in 4SC at week 49 for domagrozumab vs placebo was 0.27 (-7.4 to 7.9) seconds (p = 0.94). There were no significant between-group differences in any secondary clinical endpoints. Most patients had ≥1 adverse event in the first 48 weeks; most were mild and not treatment-related. Median serum concentrations of domagrozumab increased with administered dose within each dose level. Non-significant increases in muscle volume were observed in domagrozumab- vs placebo-treated patients. Domagrozumab was generally safe and well tolerated in patients with DMD. Efficacy measures did not support a significant treatment effect. Clinicaltrials.gov identifiers: NCT02310763 and NCT02907619.",2020,There were no significant between-group differences in any secondary clinical endpoints.,"['patients with Duchenne muscular dystrophy (DMD', '120 ambulatory boys (aged 6 to <16 years) with DMD, 80 were treated with multiple ascending doses (5, 20, and 40 mg/kg) of', 'patients with DMD', 'Duchenne muscular dystrophy']","['Domagrozumab', 'domagrozumab and 40 treated with placebo', 'domagrozumab and its open-label extension', 'domagrozumab', 'domagrozumab vs placebo', 'placebo']","['muscle volume', 'Median serum concentrations of domagrozumab', 'Mean (SD) age', 'functional tests, pharmacokinetics, and pharmacodynamics', 'safe and well tolerated', 'safety and mean change in 4-stair climb (4SC) time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013264', 'cui_str': 'Duchenne muscular dystrophy'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",120.0,0.665564,There were no significant between-group differences in any secondary clinical endpoints.,"[{'ForeName': 'Kathryn R', 'Initials': 'KR', 'LastName': 'Wagner', 'Affiliation': 'Center for Genetic Muscle Disorders, Baltimore, Kennedy Krieger Institute, Departments of Neurology and Neuroscience, Johns Hopkins School of Medicine, Baltimore, MD, USA. Electronic address: wagnerk@kennedykrieger.org.'}, {'ForeName': 'Hoda Z', 'Initials': 'HZ', 'LastName': 'Abdel-Hamid', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Jean K', 'Initials': 'JK', 'LastName': 'Mah', 'Affiliation': ""Cumming School of Medicine, University of Calgary, Alberta Children's Hospital, Calgary, AB, Canada.""}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Campbell', 'Affiliation': ""Department of Pediatrics, Clinical Neurological Sciences and Epidemiology, University of Western Ontario, Children's Hospital London Health Sciences Centre, London, ON, Canada.""}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Guglieri', 'Affiliation': 'The John Walton Muscular Dystrophy Research Centre, Newcastle University and Newcastle Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Muntoni', 'Affiliation': 'NIHR Great Ormond Street Hospital Biomedical Research Centre, Great Ormond Street Institute of Child Health, University College London, & Great Ormond Street Hospital Trust, London, UK.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Takeshima', 'Affiliation': 'Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.'}, {'ForeName': 'Craig M', 'Initials': 'CM', 'LastName': 'McDonald', 'Affiliation': ""Lawson Health Research Institute: Children's Hospital, London, ON, Canada.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kostera-Pruszczyk', 'Affiliation': 'Department of Neurology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Karachunski', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Russell J', 'Initials': 'RJ', 'LastName': 'Butterfield', 'Affiliation': 'University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Mercuri', 'Affiliation': 'Paediatric Neurology, Catholic University, Rome, Italy; Centro Clinico Nemo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Fiorillo', 'Affiliation': 'IRCCS Giannina Gaslini, Genova, Italy.'}, {'ForeName': 'Enrico S', 'Initials': 'ES', 'LastName': 'Bertini', 'Affiliation': ""Bambino Gesu Children's Research Hospital IRCCS, Rome, Italy.""}, {'ForeName': 'Cuixia', 'Initials': 'C', 'LastName': 'Tian', 'Affiliation': ""Cincinnati Children's Hospital Medical Center; College of Medicine University of Cincinnati, Cincinnati, OH, USA.""}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Statland', 'Affiliation': 'University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Alesia B', 'Initials': 'AB', 'LastName': 'Sadosky', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Vivek S', 'Initials': 'VS', 'LastName': 'Purohit', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Sarah P', 'Initials': 'SP', 'LastName': 'Sherlock', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Palmer', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Binks', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Charnas', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Marraffino', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Brenda L', 'Initials': 'BL', 'LastName': 'Wong', 'Affiliation': 'University of Massachusetts Medical School, Worcester, MA, USA.'}]",Neuromuscular disorders : NMD,['10.1016/j.nmd.2020.05.002']
2016,32522503,"Sensory aspects of acceptability of bitter-flavoured 7.5 mm film-coated tablets in adults, preschool and school children.","There is great interest in demonstrating acceptability of solid oral formulations in paediatric populations. This study investigated the acceptability of small, 7.5 mm, bitter-flavoured, coated tablets in healthy children and adults. A randomised, double-blind acceptability test was performed involving 101 children (4-12 years) and 52 adults (18-75 years). Acceptability was measured by participants as sensory assessment of taste, mouthfeel and hedonic perception, and by researcher observations of ability to swallow the tablet and negative facial expressions. Additionally, the taste-masking effect of film coatings was assessed based on the intensity of bitterness perception. At least one tablet was voluntarily swallowed by 35.7% of 4-6-year olds, 74% of 7-12-year olds and 98% of adults. The bitterness of the tablet did not affect participants' ability to swallow it. The sensory properties determined whether the tablet was acceptable. The following factors: low bitterness, high smoothness, high slipperiness and pleasant aftertaste had a positive impact on overall palatability in both populations. The paediatric scores during sensory evaluation of tablets differed from adults, showing lower acceptability. This study demonstrates the multifactorial nature of palatability of tablets and highlights that adults' palatability evaluation cannot be directly translated to a paediatric population.",2020,"The paediatric scores during sensory evaluation of tablets differed from adults, showing lower acceptability.","['healthy children and adults', 'adults, preschool and school children', '101 children (4-12 years) and 52 adults (18-75 years']",['bitter-flavoured 7.5 mm film-coated tablets'],"['overall palatability', 'Acceptability', 'sensory assessment of taste, mouthfeel and hedonic perception, and by researcher observations of ability to swallow the tablet and negative facial expressions']","[{'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0235290', 'cui_str': 'Taste bitter'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C1273643', 'cui_str': 'Film-coated tablet'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0566355', 'cui_str': 'Ability to swallow'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",101.0,0.21376,"The paediatric scores during sensory evaluation of tablets differed from adults, showing lower acceptability.","[{'ForeName': 'Justyna Katarzyna', 'Initials': 'JK', 'LastName': 'Hofmanová', 'Affiliation': 'School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Mason', 'Affiliation': 'School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom.'}, {'ForeName': 'Hannah Katharine', 'Initials': 'HK', 'LastName': 'Batchelor', 'Affiliation': 'School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom; Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, 161 Cathedral Street, Glasgow G4 0RE, United Kingdom. Electronic address: h.k.batchelor@bham.ac.uk.'}]",International journal of pharmaceutics,['10.1016/j.ijpharm.2020.119511']
2017,31431133,Online group pain management for chronic pain: Preliminary results of a novel treatment approach to teletherapy.,"OBJECTIVE


This pilot study was designed to determine the feasibility, tolerability, safety, and efficacy of group teletherapy for persons with chronic pain. The aim was to present preliminary outcomes of an open trial of group cognitive behavioural therapy (CBT) teletherapy compared with an in-person chronic pain patient group.
METHODS


We recruited 47 chronic pain patients to participate in an 8-session, 2-hour-per-week, online, structured, CBT-oriented pain management group using WebEx and compared them with 46 subjects who participated in a parallel, content-matched, in-person, weekly group. Both groups included goal setting, skills training, relaxation exercises, group discussion, and practice assignments. All subjects completed baseline measures, which were repeated post-treatment. Those in the online group participated in weekly telephone interviews and rated the perceived helpfulness of the remote group.
RESULTS


The average age of the online group participants was 54.5 ( ± 14.3) years and 70.2% were female, compared with 59.7 ( ± 13.0) years of age and 57.8% females among the in-person group members. On follow-up, both CBT groups showed modest improvements on the outcome measures. Results of this preliminary investigation comparing online teletherapy with in-person CBT suggest similar benefit. Many participants in the online group rated their experience as very helpful (62.5%; 7-10/10) and most would recommend this programme to others (93.7%; 7-10/10).
DISCUSSION


Preliminary findings suggest that online group CBT may be as effective in improving coping among persons with chronic pain as in-person groups. More rigorous controlled trials are needed to adequately assess the outcome benefit of online teletherapy for chronic pain.",2019,"Many participants in the online group rated their experience as very helpful (62.5%; 7-10/10) and most would recommend this programme to others (93.7%; 7-10/10).
","['47 chronic pain patients to participate in an 8-session, 2-hour-per-week, online, structured', 'years and 70.2% were female, compared with 59.7 (\u2009±\u200913.0) years of age and 57.8% females among the in-person group members', 'persons with chronic pain', 'chronic pain', 'person chronic pain patient group', '46 subjects who participated in a parallel, content-matched, in-person, weekly group']","['teletherapy', 'online teletherapy', 'Online group pain management', 'CBT-oriented pain management group using WebEx', 'group cognitive behavioural therapy (CBT) teletherapy', 'group teletherapy']","['feasibility, tolerability, safety, and efficacy']","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",47.0,0.0491916,"Many participants in the online group rated their experience as very helpful (62.5%; 7-10/10) and most would recommend this programme to others (93.7%; 7-10/10).
","[{'ForeName': 'Timothy Y', 'Initials': 'TY', 'LastName': 'Mariano', 'Affiliation': ""Department of Psychiatry, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Limeng', 'Initials': 'L', 'LastName': 'Wan', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Edwards', 'Affiliation': ""Department of Psychiatry, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Asimina', 'Initials': 'A', 'LastName': 'Lazaridou', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Edgar L', 'Initials': 'EL', 'LastName': 'Ross', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Robert N', 'Initials': 'RN', 'LastName': 'Jamison', 'Affiliation': ""Department of Psychiatry, Brigham and Women's Hospital, Boston, MA, USA.""}]",Journal of telemedicine and telecare,['10.1177/1357633X19870369']
2018,31570034,Evaluation of telemonitoring of continuous positive airway pressure therapy in obstructive sleep apnoea syndrome: TELEPAP pilot study.,"INTRODUCTION


Continuous positive airway pressure is an effective treatment for obstructive sleep apnoea syndrome. However, positive airway pressure compliance rates are disappointingly low, so effective interventions are needed to improve compliance in sleep apnoea. Telemonitoring has been used to improve compliance, but results have been inconsistent. This study aimed to determine outcomes of telemonitoring positive airway pressure compliance and efficacy data compared to usual care and phone-call care.
METHODS


Randomized controlled study in which 51 patients (82.4% male; between 25 and 78 years), diagnosed with moderate to severe obstructive sleep apnoea were consecutively randomized to usual care, weekly phone-call care or telemonitored care with the use of Restraxx™. All patients were submitted to a comprehensive educational programme during positive airway pressure adaptation. Patients were followed for the first four weeks of treatment with automatic positive airway pressure (AutoSet Spirit S8®; ResMed), and compliance and efficacy data were analyzed.
RESULTS


Telemonitored care group used automatic positive airway pressure an average of 5.0 ± 1.8 hours/night, usual care patients 5.1 ± 2.5 hours and phone-call care patients 3.9 ± 2.6 hours. The residual Apnoea--Hypopnoea Index was 5.3 ± 3.0 in telemonitored care, 5.0 ± 2.5 in usual care and 5.6 ± 3.8 in phone-call care. No statistically significant differences were found between groups regarding positive airway pressure compliance or efficacy ( p  = 0.296 and  p  = 0.825, respectively).
DISCUSSION


In the presence of a comprehensive educational programme during positive airway pressure adaptation, telemonitoring patients did not show benefits concerning compliance and efficacy. A larger follow-up period is needed to evaluate the long-term results of a telemonitoring programme.",2019,"No statistically significant differences were found between groups regarding positive airway pressure compliance or efficacy ( p  = 0.296 and  p  = 0.825, respectively).
","['obstructive sleep apnoea syndrome', '51 patients (82.4% male; between 25 and 78 years), diagnosed with moderate to severe obstructive sleep apnoea']","['usual care, weekly phone-call care or telemonitored care with the use of Restraxx™', 'usual care and phone-call care', 'comprehensive educational programme', 'Continuous positive airway pressure', 'telemonitoring of continuous positive airway pressure therapy']","['automatic positive airway pressure', 'positive airway pressure compliance or efficacy', 'residual Apnoea--Hypopnoea Index']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C4761101', 'cui_str': 'Automatic positive airway pressure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}]",,0.0223554,"No statistically significant differences were found between groups regarding positive airway pressure compliance or efficacy ( p  = 0.296 and  p  = 0.825, respectively).
","[{'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Fernandes', 'Affiliation': 'Sleep and Non-Invasive Ventilation Unit, Thorax Department, Centro Hospitalar Universitário Lisboa Norte, Portugal.'}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Antunes', 'Affiliation': 'Sleep and Non-Invasive Ventilation Unit, Thorax Department, Centro Hospitalar Universitário Lisboa Norte, Portugal.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Martinho', 'Affiliation': 'Sleep and Non-Invasive Ventilation Unit, Thorax Department, Centro Hospitalar Universitário Lisboa Norte, Portugal.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Carvalho', 'Affiliation': 'Sleep and Non-Invasive Ventilation Unit, Thorax Department, Centro Hospitalar Universitário Lisboa Norte, Portugal.'}, {'ForeName': 'Tiago', 'Initials': 'T', 'LastName': 'Abreu', 'Affiliation': 'Sleep and Non-Invasive Ventilation Unit, Thorax Department, Centro Hospitalar Universitário Lisboa Norte, Portugal.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Oliveira', 'Affiliation': 'Sleep and Non-Invasive Ventilation Unit, Thorax Department, Centro Hospitalar Universitário Lisboa Norte, Portugal.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Pinto', 'Affiliation': 'Sleep and Non-Invasive Ventilation Unit, Thorax Department, Centro Hospitalar Universitário Lisboa Norte, Portugal.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Bárbara', 'Affiliation': 'Sleep and Non-Invasive Ventilation Unit, Thorax Department, Centro Hospitalar Universitário Lisboa Norte, Portugal.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19875850']
2019,32497520,"39·0°C versus 38·5°C ear temperature as fever limit in children with neutropenia undergoing chemotherapy for cancer: a multicentre, cluster-randomised, multiple-crossover, non-inferiority trial.","BACKGROUND


Fever in neutropenia is the most frequent complication of chemotherapy for cancer. The temperature limit defining fever used clinically varies. A higher limit can avoid unnecessary diagnoses in patients spontaneously recovering from fever. This trial primarily aimed to determine if a limit of 39·0°C ear temperature is non-inferior to 38·5°C regarding safety.
METHODS


This cluster-randomised, multiple crossover, non-blinded, non-inferiority trial was done in six Swiss Paediatric Oncology Group centres (clusters) in Switzerland. Patients (aged 1 to <18 years) with any malignancy and treated with myelosuppressive chemotherapy expected to last 2 months or more were repeatedly randomly assigned (1:1), at the cluster level, to either monthly 39·0°C or 38·5°C ear temperature limits for diagnosis of fever in neutropenia. Diagnosis below the randomised limit was allowed for clinical reasons. Such a diagnosis implied emergency hospitalisation, examinations (including blood culture), as-needed antipyretics, and empirical intravenous broad-spectrum antibiotics. The primary outcome was the rate of fever in neutropenia with safety relevant events (SRE) per chemotherapy year; we also assessed efficacy in terms of rate of fever in neutropenia. The non-inferiority margin was 1·33 for safety, and for effiacy, the superiority margin was 1·00. This trial is registered at ClinicalTrials.gov, number NCT02324231.
FINDINGS


269 patients were recruited between April 28, 2016, to Aug 27, 2018, until the trial was stopped for success after the second interim analysis. Patients were repeatedly randomly assigned, with 1210 (48%) of 2547 randomisation periods and 92 (47%) of 195 chemotherapy years randomised to 39·0°C. SREs were diagnosed in 72 (20%) of 360 fever in neutropenia episodes (zero deaths, 16 intensive care unit admissions, 22 cases of severe sepsis, and 56 cases of bacteraemia). In 92 chemotherapy years randomised to the 39·0°C fever limit, 151 episodes of fever with neutropenia were diagnosed (1·64 per year), including 22 (15%) with SRE (0·24 per year). In 103 chemotherapy years randomised to 38·5°C, 209 episodes were diagnosed (2·03 per year), including 50 (24%) with SRE (0·49 per year). The mixed Poisson regression rate ratio (RR) of fever in neutropenia with SRE in 39·0°C versus 38·5°C was 0·56 (95% upper confidence bound 0·72). The corresponding RR of fever in neutropenia was 0·83 (95% upper confidence bound 0·98).
INTERPRETATION


In children with neutropenia and chemotherapy for cancer, 39·0°C ear temperature was safe and seemed efficacious. For Switzerland and comparable settings, 39·0°C can be recommended as new evidence-based standard fever limit except for patients with acute myeloid leukaemia or haematopoietic stem cell transplantation.
FUNDING


Swiss Cancer League (KLS-3645-02-2015).",2020,The corresponding RR of fever in neutropenia was 0·83,"['patients spontaneously recovering from fever', 'children with neutropenia undergoing chemotherapy for cancer', '269 patients were recruited between April 28, 2016, to Aug 27, 2018, until the trial was stopped for success after the second interim analysis', '103 chemotherapy years randomised to 38·5', 'six Swiss Paediatric Oncology Group centres (clusters) in Switzerland', 'patients with acute myeloid leukaemia or haematopoietic stem cell transplantation', 'Patients (aged 1 to <18 years) with any malignancy and treated with myelosuppressive chemotherapy expected to last 2 months or more were repeatedly randomly assigned (1:1), at the cluster level, to either monthly 39·0°C or 38·5']",[],"['rate of fever in neutropenia', 'fever with neutropenia', 'mixed Poisson regression rate ratio (RR) of fever in neutropenia with SRE', 'SREs', 'corresponding RR of fever in neutropenia', 'rate of fever in neutropenia with safety relevant events (SRE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C1518931', 'cui_str': 'Pediatric oncology'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",[],"[{'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",269.0,0.380971,The corresponding RR of fever in neutropenia was 0·83,"[{'ForeName': 'Christa', 'Initials': 'C', 'LastName': 'Koenig', 'Affiliation': 'Pediatric Hematology and Oncology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Bodmer', 'Affiliation': ""Pediatric Oncology, University Children's Hospital of Zürich, University of Zürich, Zürich, Switzerland.""}, {'ForeName': 'Philipp K A', 'Initials': 'PKA', 'LastName': 'Agyeman', 'Affiliation': 'Department of Pediatrics, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Niggli', 'Affiliation': ""Pediatric Oncology, University Children's Hospital of Zürich, University of Zürich, Zürich, Switzerland.""}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Adam', 'Affiliation': 'Unit of Pediatric Hematology-Oncology, Woman-Mother-Child Department, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Ansari', 'Affiliation': 'Division of Pediatric Hematology and Oncology, Department of Pediatrics and Adolescent Medicine, University Hospital of Geneva, Geneva, Switzerland; Department of Paediatrics, CANSEARCH Research Laboratory, Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Eisenreich', 'Affiliation': ""Department of Pediatric Oncology and Hematology, Children's Hospital Lucerne, Lucerne, Switzerland.""}, {'ForeName': 'Nanette', 'Initials': 'N', 'LastName': 'Keller', 'Affiliation': 'Pediatric Hematology and Oncology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Leibundgut', 'Affiliation': 'Pediatric Hematology and Oncology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Nadal', 'Affiliation': ""Pediatric Oncology, University Children's Hospital of Zürich, University of Zürich, Zürich, Switzerland.""}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Roessler', 'Affiliation': 'Pediatric Hematology and Oncology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Scheinemann', 'Affiliation': ""Division of Pediatric Hematology and Oncology, Department of Pediatrics, Kantonsspital Aarau, Aarau, Switzerland; Division of Pediatric Hematology and Oncology, University Children's Hospital Basel, University of Basel, Basel, Switzerland; Department of Pediatrics, McMaster Children's Hospital and McMaster University, Hamilton, ON, Canada.""}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Simon', 'Affiliation': ""Department of Pediatric Hematology and Oncology, Children's Hospital Medical Centre, University Hospital of Saarland, Homburg, Germany.""}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Teuffel', 'Affiliation': 'University of Tuebingen, Tuebingen, Germany; Division of Oncology, Medical Services of the Statutory Health Insurance, Baden-Wuerttemberg, Germany.'}, {'ForeName': 'Nicolas X', 'Initials': 'NX', 'LastName': 'von der Weid', 'Affiliation': ""Division of Pediatric Hematology and Oncology, University Children's Hospital Basel, University of Basel, Basel, Switzerland.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zeller', 'Affiliation': 'Swiss Paediatric Oncology Group, Coordinating Centre, Bern, Switzerland.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Zimmermann', 'Affiliation': ""Children's Research Centre, University Children's Hospital of Zürich, University of Zürich, Zürich, Switzerland; Department Public Health-Nursing Science, Faculty of Medicine, University Basel, Basel, Switzerland.""}, {'ForeName': 'Roland A', 'Initials': 'RA', 'LastName': 'Ammann', 'Affiliation': 'Pediatric Hematology and Oncology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland. Electronic address: roland.ammann@insel.ch.'}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(20)30092-4']
2020,32504895,Patterns of daytime physical activity in patients with chronic fatigue syndrome.,"OBJECTIVES


To classify patients with chronic fatigue syndrome (CFS) by pattern of physical activity and determine the clinical associations of each type.
METHODS


579 out of 641 participants with CFS from the PACE (Pacing, graded Activity, Cognitive behavioural therapy: a randomised Evaluation) trial wore an Actiwatch (accelerometer) for between 3 and 7 days before any trial treatments, which provided a measure of physical activity. Participants' activity was categorised into one of four patterns (pervasively inactive, pervasively active, boom and bust, or indeterminate) primarily using a priori definitions of activity. Clinical associations were sought with each group using an exploratory logistic regression with the indeterminate activity group being the reference group.
RESULTS


124 (21%) of the participants were classified as pervasively inactive, 65 (11%) as pervasively active, 172 (30%) showed a 'boom and bust' pattern of activity, and 218 (38%) had an indeterminate pattern. Pervasively inactive patients were more physically disabled, those in the pervasively active group were more anxious, and those in the boom and bust group had more sleep disturbance.
CONCLUSION


We were able to classify patients with CFS into groups by their daytime activity pattern. The different patterns of activity were associated with important clinical variables, suggesting that they might be helpful in determining prognosis and targeting treatments. These associations need replication.",2020,"Pervasively inactive patients were more physically disabled, those in the pervasively active group were more anxious, and those in the boom and bust group had more sleep disturbance.
","['patients with chronic fatigue syndrome', '579 out of 641 participants with CFS from the PACE (Pacing, graded Activity, Cognitive behavioural therapy', 'patients with chronic fatigue syndrome (CFS']",[],"['sleep disturbance', 'daytime physical activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015674', 'cui_str': 'Chronic fatigue syndrome'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]",[],"[{'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",641.0,0.0298142,"Pervasively inactive patients were more physically disabled, those in the pervasively active group were more anxious, and those in the boom and bust group had more sleep disturbance.
","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'King', 'Affiliation': 'Barts and the London School of Medicine and Dentistry, Queen Mary University of London, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Beynon', 'Affiliation': 'Centre for Psychiatry, Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine, Queen Mary University, London, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Chalder', 'Affiliation': ""Academic Department of Psychological Medicine, King's College London, Weston Education Centre, London, UK. Electronic address: Trudie.chalder@kcl.ac.uk.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sharpe', 'Affiliation': 'Psychological Medicine Research, Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'P D', 'Initials': 'PD', 'LastName': 'White', 'Affiliation': 'Centre for Psychiatry, Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine, Queen Mary University, London, UK.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110154']
2021,32510734,Azithromycin and COVID-19Prompt Early Use at First Signs of this Infection in Adults and Children An Approach Worthy of Consideration.,"The devastating effects of the coronavirus designated severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) has led to urgent attempts to find effective therapeutic agents for inpatient and outpatient treatment of COVID-19. Initial enthusiasm for the combination of hydroxychloroquine and azithromycin has abated. However, as a result of positive clinical experience with azithromycin used alone during the first few days of the flu-like illness caused by this coronavirus, we recommend formal clinical trials using azithromycin early in the course of a COVID-19 infection. There is one clinical trial initiated, the individually-randomized, telemedicine-based, ""Azithromycin for COVID-19 Treatment in Outpatients Nationwide (ACTION)"" based at the University of California San Francisco. This placebo-controlled trial is designed to determine the efficacy of a single 1.2 g dose of oral azithromycin to prevent COVID-19 patient progression to hospitalization. We recommend formal clinical trials of azithromycin in its prepackaged form at the first sign of COVID-19 infection in adults and children, using an initial adult dose of 500 mg followed by 250 mg per day for four days, a total cumulative dose of 1.5 g, and for children 5 to 18 years of age, 10 mg/kg on the first day followed by 5 mg/kg for four days. This article is protected by copyright. All rights reserved.",2020,The devastating effects of the coronavirus designated severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) has led to urgent attempts to find effective therapeutic agents for inpatient and outpatient treatment of COVID-19.,"['Adults and Children', 'Outpatients Nationwide (ACTION)"" based at the University of California San Francisco', 'adults and children']","['hydroxychloroquine and azithromycin', 'telemedicine-based, ""Azithromycin', 'Azithromycin', 'azithromycin', 'placebo']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0479328,The devastating effects of the coronavirus designated severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) has led to urgent attempts to find effective therapeutic agents for inpatient and outpatient treatment of COVID-19.,"[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Schwartz', 'Affiliation': 'Dermatology and Pathology, Rutgers University New Jersey Medical School, Newark, New Jersey.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Suskind', 'Affiliation': 'Professor of Pediatrics & Founding Dean Emeritus, California University of Science of Medicine, San Bernardino, California.'}]",Dermatologic therapy,['10.1111/dth.13785']
2022,32512513,The effects of repetitive transcranial magnetic stimulation on cue-induced craving in male patients with heroin use disorder.,"BACKGROUND


Craving is a central feature of addiction. Early evidence suggests that repetitive transcranial magnetic stimulation is effective in reducing cue induced craving for patients with opioid use disorder (OUD). However, trials in large populations of patients with OUDs are lacking.
METHODS


We randomly assigned 118 male heroin patients into three groups (i.e., 10 Hz rTMS, 1 Hz rTMS and a wait-list control group) from two addiction rehabilitation centers. rTMS was applied to the left dorsolateral prefrontal cortex (DLPFC) for 20 daily consecutive sessions.
FINDINGS


Results showed that 10 Hz rTMS and 1 Hz rTMS were both effective in reducing cue-induced craving scores in heroin users when compared to the wait list group. The treatment effects lasted for up to 60 days after rTMS treatment cessation.
INTERPRETATION


Our results suggest that rTMS applied to the DLPFC is effective in reducing craving severity in heroin use disorder patients. Our results also suggest that such treatment effects can last for up to 60 days after treatment cessation.",2020,"FINDINGS


Results showed that 10 Hz rTMS and 1 Hz rTMS were both effective in reducing cue-induced craving scores in heroin users when compared to the wait list group.","['male patients with heroin use disorder', '118 male heroin patients into three groups (i.e., 10', 'heroin use disorder patients', 'patients with opioid use disorder (OUD']","['repetitive transcranial magnetic stimulation', 'rTMS', 'Hz rTMS, 1\u202fHz rTMS and a wait-list control group) from two addiction rehabilitation centers']","['cue-induced craving scores', 'craving severity']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011892', 'cui_str': 'Heroin'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}]","[{'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",118.0,0.0241904,"FINDINGS


Results showed that 10 Hz rTMS and 1 Hz rTMS were both effective in reducing cue-induced craving scores in heroin users when compared to the wait list group.","[{'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; School of Psychology, Nanjing Normal University, Nanjing, Jiangsu, China; Co-innovation Center of Neuroregeneration, Nantong University, Nantong, Jiangsu, China; Ningbo Key Laboratory of Sleep Medicine, Ningbo Kangning Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Xiwen', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Yale Center for Analytical Sciences, School of Public Health, Yale University, New Haven, CT, U.S.A.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; School of Psychology, Nanjing Normal University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Qingming', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; School of Psychology, Nanjing Normal University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, U.S.A.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, U.S.A.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Luo', 'Affiliation': 'Research Center of Brain and Cognitive Neuroscience, Liaoning Normal University, Dalian, China; Key Laboratory of Brain and Cognitive Neurosience, Liaoning Province, China. Electronic address: luowb@lnnu.edu.cn.'}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, University of Toronto, Toronto, Ont., Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Ti-Fei', 'Initials': 'TF', 'LastName': 'Yuan', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Co-innovation Center of Neuroregeneration, Nantong University, Nantong, Jiangsu, China. Electronic address: ytf0707@126.com.'}]",EBioMedicine,['10.1016/j.ebiom.2020.102809']
2023,32512517,Association between cellular HIV-1 DNA level and mortality in HIV-1 infected African adults starting ART with high CD4 counts.,"BACKGROUND


High HIV-1 DNA levels in peripheral blood mononuclear cells (PBMC) were associated with a higher risk of severe morbidity and a faster decline in CD4 count in ART-naive patients. We report the association between HIV-1 DNA and mortality in HIV-infected adults in a trial of early ART in West Africa.
METHODS


In the Temprano trial, HIV-infected adults were randomly assigned to start ART immediately or defer ART. After trial termination, HIV-1 DNA was measured in whole blood samples frozen at baseline. We analyzed the association between baseline PBMC HIV-1 DNA and long-term mortality.
FINDINGS


2019 patients were followed for 9253 patient-years (median 4.9 years). At baseline, the median CD4 count was 462/mm 3  [IQR 368-571], the median plasma HIV-1 RNA 4.7 log 10  copies/ml [IQR 4.0-5.2], and the median HIV-1 DNA 2.9 log 10  copies/million PBMC [IQR 2.5-3.3]. During follow-up, 86 participants died. In univariate analysis, the hazard ratio [HR] of death was 2.67 (95% CI, 1.68-4.22) for patients with HIV-1 DNA ≥3 log 10  copies/million PBMC vs. others, and 2.10 (95% CI, 1.38-3.21) for patients with HIV-1 RNA ≥5 log10 copies/ml vs. others. In multivariate Cox regression analysis, HIV-1 DNA levels ≥3 log 10  copies/million PBMC were strongly associated mortality (adjusted HR = 2.09, 95% CI 1.24-3.52, p= 0.005) while the association between baseline plasma HIV-1 RNA and mortality was not significant.
INTERPRETATION


In these African adults who started ART with high CD4 counts, HIV-1 DNA was a strong independent predictor of death. The HIV reservoir still plays a prognostic role in the early ART era.
FUNDING


This trial was supported by the French National Agency for AIDS and viral hepatitis research (ANRS, Paris, France; Grants ANRS 12136, 12224 and 12253).",2020,"At baseline, the median CD4 count was 462/mm 3  [IQR 368-571], the median plasma HIV-1 RNA 4.7 log 10  copies/ml [IQR 4.0-5.2], and the median HIV-1 DNA 2.9 log 10  copies/million PBMC [IQR 2.5-3.3].","['HIV-infected adults in a trial of early ART in West Africa', '2019 patients were followed for 9253 patient-years (median 4.9 years', 'HIV-infected adults', 'HIV-1 infected African adults starting ART with high CD4 counts']",[],"['median plasma HIV-1 RNA', 'hazard ratio [HR] of death', 'HIV-1 DNA and mortality', 'HIV-1 DNA', 'mortality', 'median CD4 count', 'baseline plasma HIV-1 RNA and mortality', 'CD4 count']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0001747', 'cui_str': 'Western Africa'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}]",[],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0486948', 'cui_str': 'Human immunodeficiency virus 1 DNA'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",2019.0,0.300537,"At baseline, the median CD4 count was 462/mm 3  [IQR 368-571], the median plasma HIV-1 RNA 4.7 log 10  copies/ml [IQR 4.0-5.2], and the median HIV-1 DNA 2.9 log 10  copies/million PBMC [IQR 2.5-3.3].","[{'ForeName': 'Jean Baptiste', 'Initials': 'JB', 'LastName': ""N'takpe"", 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire. Electronic address: jean-baptiste.ntakpe@u-bordeaux.fr.""}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Gabillard', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': 'Raoul', 'Initials': 'R', 'LastName': 'Moh', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; Département de Dermatologie et Maladies Infectieuses, Université Felix Houphouët Boigny, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Gardiennet', 'Affiliation': 'AP-HP, CHU Necker Enfants Malades, EA 7327 Université Paris Descartes, Paris, France.'}, {'ForeName': 'Arlette', 'Initials': 'A', 'LastName': 'Emieme', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; CeDReS, CHU de Treichville, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Anani', 'Initials': 'A', 'LastName': 'Badje', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': 'Gérard M', 'Initials': 'GM', 'LastName': 'Kouame', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': ""Thomas-d'Aquin"", 'Initials': 'TD', 'LastName': 'Toni', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; CeDReS, CHU de Treichville, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Karcher', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': 'Jérome Le', 'Initials': 'JL', 'LastName': 'Carrou', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Ménan', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; CeDReS, CHU de Treichville, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Danel', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': 'Serge P', 'Initials': 'SP', 'LastName': 'Eholie', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; Département de Dermatologie et Maladies Infectieuses, Université Felix Houphouët Boigny, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Rouzioux', 'Affiliation': ""PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; AP-HP, CHU Necker Enfants Malades, EA 7327 Université Paris Descartes, Paris, France.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Anglaret', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}]",EBioMedicine,['10.1016/j.ebiom.2020.102815']
2024,32513277,"Effect of household water treatment with chlorine on diarrhea among children under the age of five years in rural areas of Dire Dawa, eastern Ethiopia: a cluster randomized controlled trial.","BACKGROUND


Diarrheal disease is a leading cause of child mortality and morbidity worldwide. Household water treatment with chlorine significantly reduces morbidity due to waterborne diseases. However, the effect of point-of-use (POU) water treatment in improving the quality of water in areas where POU is not provided free of charge and the effectiveness of home visits in inspiring household members to use POU regularly have not been studied. The objective of this study was to evaluate the effectiveness of drinking water disinfection by chlorination on diarrheal disease reduction among children under the age of 5 years in rural eastern Ethiopia.
METHODS


A cluster randomized controlled trial was carried out in rural Dire Dawa from October 2018 through January 2019. The 405 households were randomized to intervention and control arms and intervention materials were distributed after conducting a baseline survey. This trial evaluated the effectiveness of household drinking water disinfection by chlorination in reducing incidence of diarrhea among children under the age of 5 years. Intervention households received 1.2% sodium hypochlorite with demonstration of its proper use. Participants in the control households continued with their usual habits of water collection and water storage. Generalized estimation equation (GEE) with log link Poisson distribution family and exchangeable correlation matrix was used to compute crude incidence rate ratio (IRR), adjusted IRR and the corresponding 95% confidence intervals.
RESULTS


In the intervention households, in total, 281 cases of diarrhea were documented (8.7 cases per 100 person-weeks observation); in the control households, in total 446 cases of diarrhea were documented (13.8 cases per 100 person-weeks observation). A 36.0% (adjusted IRR = 0.64, 95% CI: 0.57-0.73) reduction in incidence of diarrhea was observed in the intervention arm when compared with the control arm. The highest and the lowest reductions were obtained in children of age ranges 1 to 2 years and 3 to 4 years, 42.7 and 30.4%, respectively. Adherence to the intervention was 81.3% as measured by free residual chlorine test.
CONCLUSIONS


In rural areas where diarrhea is the second leading cause of morbidity, water chlorination at the household level using liquid bleach considerably reduced episodes of diarrhea among children under the age of 5 years. Therefore, chlorinating drinking water at the household level may be a valuable interim solution for reducing the incidence of diarrheal diseases until potable water is made accessible to the majority of the population in Dire Dawa Administration and other Ethiopian communities.
TRIAL REGISTRATION


PACTR, PACTR201807815961394. Registered 16 July 2018, www.pactr.org.",2020,"The highest and the lowest reductions were obtained in children of age ranges 1 to 2 years and 3 to 4 years, 42.7 and 30.4%, respectively.","['Participants in the control households continued with their usual habits of water collection and water storage', 'children under the age of 5 years', '405 households', 'children under the age of 5 years in rural eastern Ethiopia', 'rural Dire Dawa from October 2018 through January 2019', 'children under the age of five years in rural areas of Dire Dawa, eastern Ethiopia']","['drinking water disinfection by chlorination', 'household drinking water disinfection', 'household water treatment with chlorine']","['diarrhea', 'diarrheal disease reduction', 'incidence rate ratio (IRR), adjusted IRR', 'incidence of diarrhea', 'morbidity']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517768', 'cui_str': '405'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0012683', 'cui_str': 'Disinfection'}, {'cui': 'C0175961', 'cui_str': 'Chlorination'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0599638', 'cui_str': 'Drinking Water'}, {'cui': 'C0597684', 'cui_str': 'Water Treatment'}, {'cui': 'C0008209', 'cui_str': 'Chlorine'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1290807', 'cui_str': 'Diarrheal disorder'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",405.0,0.0647436,"The highest and the lowest reductions were obtained in children of age ranges 1 to 2 years and 3 to 4 years, 42.7 and 30.4%, respectively.","[{'ForeName': 'Ephrem Tefera', 'Initials': 'ET', 'LastName': 'Solomon', 'Affiliation': 'Ethiopian Institute of Water Resources, Addis Ababa University, Addis Ababa, Ethiopia. ephtesol@gmail.com.'}, {'ForeName': 'Sirak', 'Initials': 'S', 'LastName': 'Robele', 'Affiliation': 'Ethiopian Institute of Water Resources, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Kloos', 'Affiliation': 'University of California, San Francisco Medical Center, San Francisco, CA, USA.'}, {'ForeName': 'Bezatu', 'Initials': 'B', 'LastName': 'Mengistie', 'Affiliation': 'Haramaya University, College of Health and Medical Sciences, Harar, Ethiopia.'}]",Infectious diseases of poverty,['10.1186/s40249-020-00680-9']
2025,32515868,A randomized clinical trial for neck pain among adults.,,2020,,['neck pain among adults'],[],[],"[{'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],[],,0.231617,,"[{'ForeName': 'Maryam M K', 'Initials': 'MMK', 'LastName': 'Bashir', 'Affiliation': 'College of Medicine and Health Sciences, Institute of Public Health, United Arab Emirates University, Al Ain, UAE.'}, {'ForeName': 'Elpidoforos S', 'Initials': 'ES', 'LastName': 'Soteriades', 'Affiliation': 'College of Medicine and Health Sciences, Institute of Public Health, United Arab Emirates University, Al Ain, UAE.'}]",Journal of occupational health,['10.1002/1348-9585.12119']
2026,32515879,"Author Reply to ""A randomized clinical trial for neck pain among adults"".",,2020,,['neck pain among adults'],[],[],"[{'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],[],,0.129782,,"[{'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Furukawa', 'Affiliation': 'Minami Seikyo Hospital, Nagoya-shi, Aichi-ken, Japan.'}]",Journal of occupational health,['10.1002/1348-9585.12127']
2027,32522244,Phase II trial evaluating the clinical efficacy of cefixime for treatment of active syphilis in non-pregnant women in Brazil (CeBra).,"BACKGROUND


Syphilis is a sexually and vertically transmitted infection caused by the bacteria Treponema pallidum for which there are few proven alternatives to penicillin for treatment. For pregnant women infected with syphilis, penicillin is the only WHO-recommended treatment that will treat the mother and cross the placenta to treat the unborn infant and prevent congenital syphilis. Recent shortages, national level stockouts as well as other barriers to penicillin use call for the urgent identification of alternative therapies to treat pregnant women infected with syphilis.
METHODS


This prospective, randomized, non-comparative trial will enroll non-pregnant women aged 18 years and older with active syphilis, defined as a positive rapid treponemal and a positive non-treponemal RPR test with titer ≥1:16. Women will be a, domized in a 2:1 ratio to receive the oral third generation cephalosporin cefixime at a dose of 400 mg two times per day for 10 days (n = 140) or benzathine penicillin G 2.4 million units intramuscularly based on the stage of syphilis infection (n = 70). RPR titers will be collected at enrolment, and at three, six, and nine months following treatment. Participants experiencing a 4-fold (2 titer) decline by 6 months will be considered as having an adequate or curative treatment response.
DISCUSSION


Demonstration of efficacy of cefixime in the treatment of active syphilis in this Phase 2 trial among non-pregnant women will inform a proposed randomized controlled trial to evaluate cefixime as an alternative treatment for pregnant women with active syphilis to evaluate prevention of congenital syphilis.
TRIAL REGISTRATION


Trial identifier: www.Clinicaltrials.gov, NCT03752112. Registration Date: November 22, 2018.",2020,"DISCUSSION


Demonstration of efficacy of cefixime in the treatment of active syphilis in this Phase 2 trial among non-pregnant women will inform a proposed randomized controlled trial to evaluate cefixime as an alternative treatment for pregnant women with active syphilis to evaluate prevention of congenital syphilis.
","['pregnant women infected with', 'pregnant women infected with syphilis', 'non-pregnant women', 'pregnant women with active syphilis', 'pregnant women aged 18\u2009years and older with active syphilis, defined as a positive rapid treponemal and a positive non-treponemal RPR test with titer ≥1:16', 'Participants experiencing a 4-fold (2 titer) decline by 6\u2009months will be considered as having an adequate or curative treatment response', 'non-pregnant women in Brazil (CeBra']","['benzathine penicillin', 'cefixime', 'cephalosporin cefixime', 'syphilis, penicillin']",['RPR titers'],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0039128', 'cui_str': 'Syphilis'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0201405', 'cui_str': 'Rapid plasma reagin test'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0030829', 'cui_str': 'benzathine benzylpenicillin'}, {'cui': 'C0060400', 'cui_str': 'Cefixime'}, {'cui': 'C3536856', 'cui_str': 'Cephalosporin antibiotic product'}, {'cui': 'C0039128', 'cui_str': 'Syphilis'}, {'cui': 'C0030842', 'cui_str': 'Penicillin'}]","[{'cui': 'C0201405', 'cui_str': 'Rapid plasma reagin test'}, {'cui': 'C0475208', 'cui_str': 'Titer'}]",,0.230271,"DISCUSSION


Demonstration of efficacy of cefixime in the treatment of active syphilis in this Phase 2 trial among non-pregnant women will inform a proposed randomized controlled trial to evaluate cefixime as an alternative treatment for pregnant women with active syphilis to evaluate prevention of congenital syphilis.
","[{'ForeName': 'Melanie M', 'Initials': 'MM', 'LastName': 'Taylor', 'Affiliation': 'Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland. mtaylor@who.int.'}, {'ForeName': 'Edna Oliveira', 'Initials': 'EO', 'LastName': 'Kara', 'Affiliation': 'Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Maria Alix Leite', 'Initials': 'MAL', 'LastName': 'Araujo', 'Affiliation': 'University of Fortaleza (UNIFOR), Fortaleza, Brazil.'}, {'ForeName': 'Mariangela Freitas', 'Initials': 'MF', 'LastName': 'Silveira', 'Affiliation': 'Post-Graduate Program in Epidemiology, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Angelica Espinosa', 'Initials': 'AE', 'LastName': 'Miranda', 'Affiliation': 'Federal University of Espírito Santo, Vitória, Brazil.'}, {'ForeName': 'Ivo Castelo', 'Initials': 'IC', 'LastName': 'Branco Coelho', 'Affiliation': 'Federal University of Ceará, Ambulatório de IST do Hospital Universitário da Universidade Federal do Ceará, Fortaleza, Brazil.'}, {'ForeName': 'Maria Luiza', 'Initials': 'ML', 'LastName': 'Bazzo', 'Affiliation': 'Federal University of Santa Catarina, Florianópolis, Brazil.'}, {'ForeName': 'Gerson Fernando', 'Initials': 'GF', 'LastName': 'Mendes Pereira', 'Affiliation': 'Brazil Ministry of Health, Secretariat for Health Surveillance, Department of Chronic Conditions and Sexually Transmitted Infections, Brasília, Brazil.'}, {'ForeName': 'Silvana', 'Initials': 'S', 'LastName': 'Pereira Giozza', 'Affiliation': 'Brazil Ministry of Health, Secretariat for Health Surveillance, Department of Chronic Conditions and Sexually Transmitted Infections, Brasília, Brazil.'}, {'ForeName': 'Ximena Pamela Díaz', 'Initials': 'XPD', 'LastName': 'Bermudez', 'Affiliation': 'University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Maeve B', 'Initials': 'MB', 'LastName': 'Mello', 'Affiliation': 'University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Ndema', 'Initials': 'N', 'LastName': 'Habib', 'Affiliation': 'Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'My Huong', 'Initials': 'MH', 'LastName': 'Nguyen', 'Affiliation': 'Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Soe Soe', 'Initials': 'SS', 'LastName': 'Thwin', 'Affiliation': 'Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Broutet', 'Affiliation': 'Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}]",BMC infectious diseases,['10.1186/s12879-020-04980-1']
2028,32525036,"One layer or two: Does it matter when performing a handsewn bowel anastomosis? Invited Commentary on ""Efficacy of single layered intestinal anastomosis over double layered intestinal anastamosis-an open labeled, randomized controlled trial"".",,2020,,[],['single layered intestinal anastomosis'],[],[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}]",[],,0.075286,,"[{'ForeName': 'Glenn K', 'Initials': 'GK', 'LastName': 'Wakam', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, MI, USA. Electronic address: gwakam@med.umich.edu.'}, {'ForeName': 'Hasan B', 'Initials': 'HB', 'LastName': 'Alam', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, MI, USA.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.05.088']
2029,31760855,"The sustained effects of extending cardiac rehabilitation with a six-month telemonitoring and telecoaching programme on fitness, quality of life, cardiovascular risk factors and care utilisation in CAD patients: The TeleCaRe study.","INTRODUCTION


The aim of this study was to assess the acute and sustained effects of a six-month heart-rate-based telerehabilitation programme, following the completion of cardiac rehabilitation (CR), on peak oxygen uptake (peakVO 2 ), quality of life (QoL), cardiovascular risk factors and care utilisation in patients with coronary artery disease (CAD).
METHODS


A total of 122 patients with CAD were randomised, after the completion of CR, to an intervention group with six months of telemonitoring and telecoaching (TELE) or a control group with a traditional six-month follow-up programme with monthly calls (CON). The primary outcome was peakVO 2  at 12 months, to assess the sustained effects of TELE. The secondary outcomes included QoL, cardiovascular risk factors (lipid spectrum), major adverse cardiovascular events (MACE) and habitual physical activity.
RESULTS


PeakVO 2  increased significantly from baseline to 12 months in TELE (+2.5 mL·kg -1 min -1  (95% CI 1.5-3.2)) and CON (+1.9 mL·kg -1 min -1  (95% CI 1.0-2.5)), and did not differ between groups (P = 0.28). Similarly, QoL (P = 0.31), total cholesterol (P = 0.45), MACE (P = 0.86) did not differ between groups and in time.
DISCUSSION


Extending CR with a heart-rate-based telerehabilitation programme did not yield additional sustainable health benefits compared with regular care with monthly telephone calls. These observations highlight that both telerehabilitation and regular care with monthly telephone calls may prevent the typically observed reductions in peakVO 2  following the completion of a CR programme.Trial registration: Dutch Trial Register NL4140 (registered 6 December 2014).",2019,"Similarly, QoL (P = 0.31), total cholesterol (P = 0.45), MACE (P = 0.86) did not differ between groups and in time.
","['122 patients with CAD', 'patients with coronary artery disease (CAD', 'CAD patients']","['TELE', 'telecoaching programme', 'telemonitoring and telecoaching (TELE) or a control group with a traditional six-month follow-up programme with monthly calls (CON', 'six-month heart-rate-based telerehabilitation programme', 'CON', 'cardiac rehabilitation (CR']","['QoL, cardiovascular risk factors (lipid spectrum), major adverse cardiovascular events (MACE) and habitual physical activity', 'sustained effects of TELE', 'total cholesterol', 'peak oxygen uptake (peakVO 2 ), quality of life (QoL), cardiovascular risk factors and care utilisation', 'fitness, quality of life, cardiovascular risk factors and care utilisation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",122.0,0.22025,"Similarly, QoL (P = 0.31), total cholesterol (P = 0.45), MACE (P = 0.86) did not differ between groups and in time.
","[{'ForeName': 'Johan A', 'Initials': 'JA', 'LastName': 'Snoek', 'Affiliation': '*Authors contributed equally to the study. Isala Heart Centre, Zwolle, The Netherlands.'}, {'ForeName': 'Esther P', 'Initials': 'EP', 'LastName': 'Meindersma', 'Affiliation': '*Authors contributed equally to the study. Isala Heart Centre, Zwolle, The Netherlands.'}, {'ForeName': 'Leonie F', 'Initials': 'LF', 'LastName': 'Prins', 'Affiliation': 'Diagram, Zwolle, The Netherlands.'}, {'ForeName': 'Arnoud Wj', 'Initials': 'AW', 'LastName': ""Van't Hof"", 'Affiliation': 'Cardiology Department, Maastricht UMC, Maastricht, The Netherlands.'}, {'ForeName': 'Menko-Jan', 'Initials': 'MJ', 'LastName': 'de Boer', 'Affiliation': 'Cardiology Department, Radboud UMC, Nijmegen, The Netherlands.'}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Hopman', 'Affiliation': 'Radboud Institute for Health Sciences, Department of Physiology, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Thijs Mh', 'Initials': 'TM', 'LastName': 'Eijsvogels', 'Affiliation': 'Radboud Institute for Health Sciences, Department of Physiology, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Ed P', 'Initials': 'EP', 'LastName': 'de Kluiver', 'Affiliation': '*Authors contributed equally to the study. Isala Heart Centre, Zwolle, The Netherlands.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19885793']
2030,31816075,"Morning Bright Light Treatment for Chronic Low Back Pain: Potential Impact on the Volatility of Pain, Mood, Function, and Sleep.","OBJECTIVES


Most treatment outcome studies for people with chronic low back pain (CLBP) have based analyses on and reported only the mean levels of these factors. However, high levels of pain, mood, function, and sleep volatility may represent unique factors contributing to diminished quality of life. Our goal was to determine whether bright light treatment affected both mean levels of pain, mood, function, and sleep and reduced volatility in these outcomes.
METHODS


US military veterans with CLBP (N = 22) underwent an open trial with a seven-day baseline, followed by 13 days of a one-hour morning bright light treatment self-administered at their home and a 30-day follow-up. Participants completed daily diary measures at 12 Pm and 6 Pm every day during the three study epochs.
RESULTS


Using location scale modeling, results suggested that, in addition to being associated with changes in mean levels of pain intensity, pain interference, negative affect, and sleep quality, bright light treatment was also related to reductions in the volatility of pain intensity and negative affect, reductions that were largely maintained during follow-up.
CONCLUSIONS


Changes in mean levels and volatility were independent factors, suggesting that bright light treatment was related to participants experiencing fewer ""pain flares."" These findings underscore the potential importance of volatility as a future treatment target.",2020,"CONCLUSIONS


Changes in mean levels and volatility were independent factors, suggesting that bright light treatment was related to participants experiencing fewer ""pain flares.","['US military veterans with CLBP (N\u2009=\u200922', 'people with chronic low back pain (CLBP', 'Chronic Low Back Pain']",['Morning Bright Light Treatment'],"['volatility of pain intensity', 'daily diary measures', 'pain flares', 'mean levels of pain intensity, pain interference, negative affect, and sleep quality', 'mean levels of pain, mood, function, and sleep and reduced volatility']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0423899', 'cui_str': 'Above average intellect'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1959569', 'cui_str': 'Volatility'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]",22.0,0.0561542,"CONCLUSIONS


Changes in mean levels and volatility were independent factors, suggesting that bright light treatment was related to participants experiencing fewer ""pain flares.","[{'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Burns', 'Affiliation': 'Department of Behavioral Sciences, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gerhart', 'Affiliation': 'Department of Psychology, Central Michigan University, Mount Pleasant, Michigan.'}, {'ForeName': 'Muneer', 'Initials': 'M', 'LastName': 'Rizvydeen', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Momoko', 'Initials': 'M', 'LastName': 'Kimura', 'Affiliation': 'Department of Behavioral Sciences, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Helen J', 'Initials': 'HJ', 'LastName': 'Burgess', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan, USA.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz235']
2031,32530472,Effect of a Comprehensive Cardiovascular Risk Reduction Intervention in Persons With Serious Mental Illness: A Randomized Clinical Trial.,"Importance


Persons with serious mental illness have a cardiovascular disease mortality rate more than twice that of the overall population. Meaningful cardiovascular risk reduction requires targeted efforts in this population, who often have psychiatric symptoms and cognitive impairment.
Objective


To determine the effectiveness of an 18-month multifaceted intervention incorporating behavioral counseling, care coordination, and care management for overall cardiovascular risk reduction in adults with serious mental illness.
Design, Setting, and Participants


This randomized clinical trial was conducted from December 2013 to November 2018 at 4 community mental health outpatient programs in Maryland. The study recruited adults with at least 1 cardiovascular disease risk factor (hypertension, diabetes, dyslipidemia, current tobacco smoking, and/or overweight or obesity) attending the mental health programs. Of 398 participants screened, 269 were randomized to intervention (132 participants) or control (137 participants). Data collection staff were blinded to group assignment. Data were analyzed on the principle of intention to treat, and data analysis was performed from November 2018 to March 2019.
Interventions


A health coach and nurse provided individually tailored cardiovascular disease risk reduction behavioral counseling, collaborated with physicians to implement appropriate risk factor management, and coordinated with mental health staff to encourage attainment of health goals. Programs offered physical activity classes and received consultation on serving healthier meals; intervention and control participants were exposed to these environmental changes.
Main Outcomes and Measures


The primary outcome was the change in the risk of cardiovascular disease from the global Framingham Risk Score (FRS), which estimates the 10-year probability of a cardiovascular disease event, from baseline to 18 months, expressed as percentage change for intervention compared with control.
Results


Of 269 participants randomized (mean [SD] age, 48.8 [11.9] years; 128 men [47.6%]), 159 (59.1%) had a diagnosis of schizophrenia or schizoaffective disorder, 67 (24.9%) had bipolar disorder, and 38 (14.1%) had major depressive disorder. At 18 months, the primary outcome, FRS, was obtained for 256 participants (95.2%). The mean (SD) baseline FRS was 11.5% (11.5%) (median, 8.6%; interquartile range, 3.9%-16.0%) in the intervention group and 12.7% (12.7%) (median, 9.1%; interquartile range, 4.0%-16.7%) in the control group. At 18 months, the mean (SD) FRS was 9.9% (10.2%) (median, 7.7%; interquartile range, 3.1%-12.0%) in the intervention group and 12.3% (12.0%) (median, 9.7%; interquartile range, 4.0%-15.9%) in the control group. Compared with the control group, the intervention group experienced a 12.7% (95% CI, 2.5%-22.9%; P = .02) relative reduction in FRS at 18 months.
Conclusions and Relevance


An 18-month behavioral counseling, care coordination, and care management intervention statistically significantly reduced overall cardiovascular disease risk in adults with serious mental illness. This intervention provides the means to substantially reduce health disparities in this high-risk population.
Trial Registration


ClinicalTrials.gov Identifier: NCT02127671.",2020,"Compared with the control group, the intervention group experienced a 12.7% (95% CI, 2.5%-22.9%; P = .02) relative reduction in FRS at 18 months.
","['Persons With Serious Mental Illness', 'adults with at least 1 cardiovascular disease risk factor (hypertension, diabetes, dyslipidemia, current tobacco smoking, and/or overweight or obesity) attending the mental health programs', 'adults with serious mental illness', '398 participants screened, 269 were randomized to intervention (132 participants) or control (137 participants', '269 participants randomized (mean [SD] age', 'Importance\n\n\nPersons with serious mental illness', '48.8 [11.9] years; 128 men [47.6%]), 159 (59.1%) had a diagnosis of schizophrenia or schizoaffective disorder, 67 (24.9%) had bipolar disorder, and 38 (14.1%) had major depressive disorder', 'December 2013 to November 2018 at 4 community mental health outpatient programs in Maryland']","['Comprehensive Cardiovascular Risk Reduction Intervention', 'multifaceted intervention incorporating behavioral counseling, care coordination, and care management']","['mean (SD) baseline FRS', 'FRS', 'change in the risk of cardiovascular disease from the global Framingham Risk Score (FRS), which estimates the 10-year probability of a cardiovascular disease event', 'overall cardiovascular disease risk', 'cardiovascular disease mortality rate', 'mean (SD) FRS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0453996', 'cui_str': 'Tobacco smoking behavior - finding'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4546207', 'cui_str': 'Behavioral counseling'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",269.0,0.170462,"Compared with the control group, the intervention group experienced a 12.7% (95% CI, 2.5%-22.9%; P = .02) relative reduction in FRS at 18 months.
","[{'ForeName': 'Gail L', 'Initials': 'GL', 'LastName': 'Daumit', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Arlene T', 'Initials': 'AT', 'LastName': 'Dalcin', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Faith B', 'Initials': 'FB', 'LastName': 'Dickerson', 'Affiliation': 'Sheppard Pratt Health System, Towson, Maryland.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'A Eden', 'Initials': 'AE', 'LastName': 'Evins', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Cather', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Gerald J', 'Initials': 'GJ', 'LastName': 'Jerome', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Deborah R', 'Initials': 'DR', 'LastName': 'Young', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena.'}, {'ForeName': 'Jeanne B', 'Initials': 'JB', 'LastName': 'Charleston', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Joseph V', 'Initials': 'JV', 'LastName': 'Gennusa', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Goldsholl', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Cook', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Heller', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Emma E', 'Initials': 'EE', 'LastName': 'McGinty', 'Affiliation': 'Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Rosa M', 'Initials': 'RM', 'LastName': 'Crum', 'Affiliation': 'Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Nae-Yuh', 'Initials': 'NY', 'LastName': 'Wang', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.7247']
2032,32526188,"Efficacy, duration of protection, birth outcomes, and infant growth associated with influenza vaccination in pregnancy: a pooled analysis of three randomised controlled trials.","BACKGROUND


Maternal influenza immunisation can reduce morbidity and mortality associated with influenza infection in pregnant women and young infants. We aimed to determine the vaccine efficacy of maternal influenza immunisation against maternal and infant PCR-confirmed influenza, duration of protection, and the effect of gestational age at vaccination on vaccine efficacy, birth outcomes, and infant growth up to 6 months of age.
METHODS


We did a pooled analysis of three randomised controlled trials done in Nepal (2011-2014), Mali (2011-2014), and South Africa (2011-2013). Pregnant women, gestational age 17-34 weeks in Nepal, 28 weeks or more in Mali, and 20-36 weeks in South Africa, were enrolled. Women were randomly assigned 1:1 to a study group, in which they received trivalent inactivated influenza vaccine (IIV) in all three trials, or a control group, in which they received saline placebo in Nepal and South Africa or quadrivalent meningococcal conjugate vaccine in Mali. Enrolment at all sites was complete by April 24, 2013. Infants and women were assessed for respiratory illness, and samples from those that met the case definition were tested for influenza by PCR testing. Growth measurements, including length and weight, were obtained at birth at all sites, at 24 weeks in South Africa, and at 6 months in Nepal and Mali. The three trials are registered with ClinicalTrials.gov, numbers NCT01430689, NCT01034254, and NCT02465190.
FINDINGS


10 002 women and 9800 liveborn infants were included. Pooled efficacy of maternal vaccination to prevent infant PCR-confirmed influenza up to 6 months of age was 35% (95% CI 19 to 47). The pooled estimate was 56% (28 to 73) within the first 2 months of life, 39% (11 to 58) between 2 and 4 months, and 19% (-9 to 40) between 4 and 6 months. In women, from enrolment during pregnancy to the end of follow-up at 6 months postpartum, the vaccine was 50% (95% CI 32-63) efficacious against PCR-confirmed influenza. Efficacy was 42% (12 to 61) during pregnancy and 60% (36 to 75) postpartum. In women vaccinated before 29 weeks gestational age, the estimated efficacy was 30% (-2 to 52), and in women vaccinated at or after 29 weeks, efficacy was 71% (50 to 83). Efficacy was similar in infants born to mothers vaccinated before or after 29 weeks gestation (34% [95% CI 12 to 51] vs 35% [11 to 52]). There was no overall association between maternal vaccination and low birthweight, stillbirth, preterm birth, and small for gestational age. At 6 months of age, the intervention and control groups were similar in terms of underweight (weight-for-age), stunted (length-for-age), and wasted (weight-for-length). Median centile change from birth to 6 months of age was similar between the intervention and the control groups for both weight and length.
INTERPRETATION


The assessment of efficacy for women vaccinated before 29 weeks gestational age might have been underpowered, because the point estimate suggests that there might be efficacy despite wide CIs. Estimates of efficacy against PCR-confirmed influenza and safety in terms of adverse birth outcomes should be incorporated into any further consideration of maternal influenza immunisation recommendations.
FUNDING


Bill & Melinda Gates Foundation.",2020,"Median centile change from birth to 6 months of age was similar between the intervention and the control groups for both weight and length.
","['10', 'women vaccinated before 29 weeks gestational age', 'Nepal (2011-2014), Mali (2011-2014), and South Africa (2011-2013', 'pregnant women and young infants', 'pregnancy', '002 women and 9800 liveborn infants were included', 'Pregnant women, gestational age 17-34 weeks in Nepal, 28 weeks or more in Mali, and 20-36 weeks in South Africa, were enrolled']","['maternal influenza immunisation', 'maternal vaccination', 'saline placebo in Nepal and South Africa or quadrivalent meningococcal conjugate vaccine in Mali', 'trivalent inactivated influenza vaccine (IIV']","['vaccine efficacy, birth outcomes, and infant growth', 'maternal vaccination and low birthweight, stillbirth, preterm birth, and small for gestational age', 'Efficacy, duration of protection, birth outcomes, and infant growth', 'Efficacy', 'Growth measurements, including length and weight']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0024581', 'cui_str': 'Mali'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0496655', 'cui_str': 'Singleton, unspecified as to place of birth'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C1660580', 'cui_str': 'Meningococcal conjugate vaccine'}, {'cui': 'C0024581', 'cui_str': 'Mali'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",10002.0,0.36851,"Median centile change from birth to 6 months of age was similar between the intervention and the control groups for both weight and length.
","[{'ForeName': 'Saad B', 'Initials': 'SB', 'LastName': 'Omer', 'Affiliation': 'Yale Institute for Global Health, New Haven, CT, USA; Department of Internal Medicine (Infectious Diseases), Yale School of Medicine, New Haven, CT, USA; Yale School of Nursing, New Haven, CT, USA; Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT, USA. Electronic address: saad.omer@yale.edu.'}, {'ForeName': 'Dayna R', 'Initials': 'DR', 'LastName': 'Clark', 'Affiliation': 'Department of Epidemiology, Emory University Rollins School of Public Health, Atlanta, GA, USA.'}, {'ForeName': 'Shabir A', 'Initials': 'SA', 'LastName': 'Madhi', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Milagritos D', 'Initials': 'MD', 'LastName': 'Tapia', 'Affiliation': 'Centre pour le Développement des Vaccins, Bamako, Mali; Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Marta C', 'Initials': 'MC', 'LastName': 'Nunes', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Clare L', 'Initials': 'CL', 'LastName': 'Cutland', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Eric A F', 'Initials': 'EAF', 'LastName': 'Simões', 'Affiliation': ""Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Section of Infectious Diseases, Department of Pediatrics, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO, USA; Department of Epidemiology, Center for Global Health Colorado School of Public Health, Aurora, CO, USA.""}, {'ForeName': 'Anushka R', 'Initials': 'AR', 'LastName': 'Aqil', 'Affiliation': 'Department of Health, Behavior, Society, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Katz', 'Affiliation': 'Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Tielsch', 'Affiliation': 'Department of Global Health, Milken Institute School of Public Health, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Steinhoff', 'Affiliation': ""Cincinnati Children's Hospital Global Health Center, Cincinnati, OH, USA.""}, {'ForeName': 'Niteen', 'Initials': 'N', 'LastName': 'Wairagkar', 'Affiliation': 'Bill & Melinda Gates Foundation, Seattle, WA, USA; Vaccines For All, Pune, India.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30479-5']
2033,32526490,Creativity on tap 2: Investigating dose effects of alcohol on cognitive control and creative cognition.,"This preregistered study aimed to replicate and extend research on the role of cognitive control in creative cognition by examining dose effects of alcohol in a randomized controlled trial. A sample of 125 participants was randomly assigned to three experimental groups, either drinking alcoholic beer (BAC = 0.03 or 0.06) or drinking non-alcoholic beer (placebo-control group). Before and after the alcohol intervention, participants completed two tests of cognitive control and two established creative thinking tasks. A BAC of 0.06 led to an impairment of verbal fluency, while working memory performance was unaffected at both alcohol levels. Alcohol had no facilitative or detrimental effects on creative thinking performance, neither in terms of RAT performance, divergent thinking fluency or divergent thinking creativity. These results indicate that moderate alcohol levels have dose-dependent, selective effects on cognitive control, and that minor impairments of cognitive control do not generally increase or attenuate creative thinking performance.",2020,"Alcohol had no facilitative or detrimental effects on creative thinking performance, neither in terms of RAT performance, divergent thinking fluency or divergent thinking creativity.",['A sample of 125 participants'],"['drinking alcoholic beer (BAC\xa0=\xa00.03 or 0.06) or drinking non-alcoholic beer (placebo-control group', 'alcohol', 'cognitive control and two established creative thinking tasks']","['creative thinking performance', 'verbal fluency, while working memory performance', 'RAT performance, divergent thinking fluency or divergent thinking creativity', 'cognitive control and creative cognition']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4319551', 'cui_str': '125'}]","[{'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0004922', 'cui_str': 'Beer'}, {'cui': 'C0004599', 'cui_str': 'Bacitracin'}, {'cui': 'C4517402', 'cui_str': '0.03'}, {'cui': 'C4517412', 'cui_str': '0.06'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0010297', 'cui_str': 'Creative thought'}]","[{'cui': 'C0010297', 'cui_str': 'Creative thought'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",125.0,0.0319793,"Alcohol had no facilitative or detrimental effects on creative thinking performance, neither in terms of RAT performance, divergent thinking fluency or divergent thinking creativity.","[{'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Benedek', 'Affiliation': 'Institute of Psychology, University of Graz, Austria. Electronic address: mathias.benedek@uni-graz.at.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Zöhrer', 'Affiliation': 'Institute of Psychology, University of Graz, Austria.'}]",Consciousness and cognition,['10.1016/j.concog.2020.102972']
2034,32526502,The effect of rumination and distraction on auditory hallucinatory experiences: An analogue experimental study.,"BACKGROUND AND OBJECTIVES


The cognitive model of voices suggests that negative appraisals of hallucinatory experiences result in responses, such as rumination, which maintain voice-hearing. Our principal aim was to investigate the effect of rumination on the frequency of voice-hearing.
METHODS


A two-group randomised experimental design was employed using a non-clinical sample. A total of 106 participants completed baseline measures of trait rumination, hallucination-proneness, mood and state negative affect, and were presented with a voice-hearing paradigm. False feedback designed to cause a negative interpretation of auditory intrusions was provided and participants were randomly allocated to either a distraction or rumination condition. Participants performed the auditory task for a second time, and the total number of false alarms and distress scores were compared between groups.
RESULTS


A Mann-Whitney U test revealed that the manipulation of rumination was successful (p = 0.007). We did not detect a statistically significant difference between the distraction and rumination groups for total false alarms (p = 0.282) or distress (p = 0.387) scores.
LIMITATIONS


Findings largely relate to a female undergraduate psychology sample.
CONCLUSION


Results of this non-clinical study do not support the hypothesis that rumination leads to an increase in the frequency of voice-hearing on a laboratory task.",2020,"We did not detect a statistically significant difference between the distraction and rumination groups for total false alarms (p = 0.282) or distress (p = 0.387) scores.
","['106 participants completed baseline measures of trait rumination, hallucination-proneness, mood and state negative affect, and were presented with a voice-hearing paradigm', 'auditory hallucinatory experiences', 'female undergraduate psychology sample']","['distraction or rumination condition', 'rumination and distraction']","['distress', 'auditory task', 'total number of false alarms and distress scores', 'frequency of voice-hearing']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0018524', 'cui_str': 'Hallucinations'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}]",106.0,0.0413272,"We did not detect a statistically significant difference between the distraction and rumination groups for total false alarms (p = 0.282) or distress (p = 0.387) scores.
","[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Anderson', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Hartley', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences, The University of Manchester, Manchester, United Kingdom; Pennine Care NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Morrison', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences, The University of Manchester, Manchester, United Kingdom; Greater Manchester Mental Health NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Bucci', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences, The University of Manchester, Manchester, United Kingdom; Greater Manchester Mental Health NHS Foundation Trust, Manchester, UK. Electronic address: sandra.bucci@manchester.ac.uk.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101592']
2035,32526534,Trial design of the RICH LIFE Project: A cluster randomized pragmatic trial comparing the effectiveness of health system only vs health system plus a collaborative/stepped care intervention to reduce hypertension disparities.,"Disparities in the control of hypertension and other cardiovascular disease risk factors are well-documented in the United States, even among patients seen regularly in the healthcare system. Few existing approaches explicitly address disparities in hypertension care and control. This paper describes the RICH LIFE Project (Reducing Inequities in Care of Hypertension: Lifestyle Improvement for Everyone) design.
METHODS


RICH LIFE is a two-arm, cluster-randomized trial, comparing the effectiveness of enhanced standard of care, ""Standard of Care Plus"" (SCP), to a multi-level intervention, ""Collaborative Care/Stepped Care"" (CC/SC), for improving blood pressure (BP) control and patient activation and reducing disparities in BP control among 1890 adults with uncontrolled hypertension and at least one other cardiovascular disease risk factor treated at 30 primary care practices in Maryland and Pennsylvania. Fifteen practices randomized to the SCP arm receive standardized BP measurement training; race/ethnicity-specific audit and feedback of BP control rates; and quarterly webinars in management practices, quality improvement and disparities reduction. Fifteen practices in the CC/SC arm receive the SCP interventions plus implementation of the collaborative care model with stepped-care components (community health worker referrals and virtual specialist-panel consults). The primary clinical outcome is BP control (<140/90 mm Hg) at 12 months. The primary patient-reported outcome is change from baseline in self-reported patient activation at 12 months.
DISCUSSION


This study will provide knowledge about the feasibility of leveraging existing resources in routine primary care and potential benefits of adding supportive community-facing roles to improve hypertension care and reduce disparities.
TRIAL REGISTRATION


Clinicaltrials.govNCT02674464.",2020,Fifteen practices in the CC/SC arm receive the SCP interventions plus implementation of the collaborative care model with stepped-care components (community health worker referrals and virtual specialist-panel consults).,['1890 adults with uncontrolled hypertension and at least one other cardiovascular disease risk factor treated at 30 primary care practices in Maryland and Pennsylvania'],"['RICH LIFE Project', 'enhanced standard of care, ""Standard of Care Plus"" (SCP), to a multi-level intervention, ""Collaborative Care/Stepped Care"" (CC/SC', 'SCP arm receive standardized BP measurement training; race/ethnicity-specific audit and feedback of BP control rates', 'health system only vs health system plus a collaborative/stepped care intervention']","['blood pressure (BP) control and patient activation', 'hypertension disparities', 'BP control']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0348668', 'cui_str': 'Other and unspecified disorders of circulatory system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}]","[{'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",1890.0,0.09569,Fifteen practices in the CC/SC arm receive the SCP interventions plus implementation of the collaborative care model with stepped-care components (community health worker referrals and virtual specialist-panel consults).,"[{'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Cooper', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. Electronic address: lisa.cooper@jhmi.edu.'}, {'ForeName': 'Jill A', 'Initials': 'JA', 'LastName': 'Marsteller', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Carson', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Katherine B', 'Initials': 'KB', 'LastName': 'Dietz', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Romsai T', 'Initials': 'RT', 'LastName': 'Boonyasai', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Alvarez', 'Affiliation': 'Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; John Hopkins University School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Chidinma A', 'Initials': 'CA', 'LastName': 'Ibe', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Deidra C', 'Initials': 'DC', 'LastName': 'Crews', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Hsin-Chieh', 'Initials': 'HC', 'LastName': 'Yeh', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Cheryl R', 'Initials': 'CR', 'LastName': 'Dennison-Himmelfarb', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; John Hopkins University School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Lisa H', 'Initials': 'LH', 'LastName': 'Lubomski', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Tanjala S', 'Initials': 'TS', 'LastName': 'Purnell', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Hill-Briggs', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; John Hopkins University School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Nae-Yuh', 'Initials': 'NY', 'LastName': 'Wang', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.05.001']
2036,32526606,Choosing vaginal birth after caesarean section: Motivating factors.,"OBJECTIVES


to examine the factors that motivate women who have had a previous caesarean section to consider planning a vaginal birth.
DESIGN


a qualitative descriptive study with thematic analysis, drawing on interviews with women participating in a two arm, un-blinded randomised controlled trial (RCT) of midwifery continuity of care for increasing the proportion of women planning VBAC.
SETTING


A Maternity Unit attached to a district hospital in an outer metropolitan area of Sydney, Australia.
PARTICIPANTS


a purposive sample of 18 women participating in an RCT who had experienced previous caesarean section and had no contraindications for vaginal birth.
FINDINGS


These women were committed to natural birth and drew on their previous experience of caesarean section to highlight the downside of recovery post caesarean section. Decision making for these women was complex. During the decision-making process, women individualised the information provided to balance risk and chance within the context of their own circumstance. Supportive healthcare providers were important in motivating women towards vaginal birth and midwives were identified as being more supportive than obstetricians.
CONCLUSIONS


Recovery post caesarean section is an important consideration that is under emphasised in the informed consent process. There is opportunity for midwives to contribute proactively in promoting vaginal birth for women who have experienced a previous caesarean section.
IMPLICATIONS FOR PRACTICE


women should be assisted to make informed choices with balanced information that includes recovery from surgical birth. Models of care that include a significant role for midwives and strategies that proactively encourage vaginal birth for women after previous caesarean section are needed.",2020,"Supportive healthcare providers were important in motivating women towards vaginal birth and midwives were identified as being more supportive than obstetricians.
","['A Maternity Unit attached to a district hospital in an outer metropolitan area of Sydney, Australia', 'a purposive sample of 18 women participating in an RCT who had experienced previous caesarean section and had no contraindications for vaginal birth', 'motivate women who have had a previous caesarean section to consider planning a vaginal birth', 'women who have experienced a previous caesarean section']",[],[],"[{'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0020006', 'cui_str': 'District hospital'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0269733', 'cui_str': 'Previous caesarean section'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]",[],[],18.0,0.0830958,"Supportive healthcare providers were important in motivating women towards vaginal birth and midwives were identified as being more supportive than obstetricians.
","[{'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Davis', 'Affiliation': 'University of Canberra and ACT Government Health Directorate, Faculty of Health, Bruce, 2617, ACT, Australia. Electronic address: Deborah.davis@canberra.edu.au.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'S Homer', 'Affiliation': 'Maternal and Child Health Program, Burnet Institute, Melbourne, Australia; Centre for Midwifery, Child and Family Health, Faculty of Health, University of Technology Sydney, Australia.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Clack', 'Affiliation': 'Centre for Midwifery, Child and Family Health, Faculty of Health, University of Technology Sydney, Australia.'}, {'ForeName': 'Sabera', 'Initials': 'S', 'LastName': 'Turkmani', 'Affiliation': 'Centre for Midwifery, Child and Family Health, Faculty of Health, University of Technology Sydney, Australia.'}, {'ForeName': 'Maralyn', 'Initials': 'M', 'LastName': 'Foureur', 'Affiliation': 'Centre for Midwifery, Child and Family Health, Faculty of Health, University of Technology Sydney, Australia; Hunter New England Local Health District & University of Newcastle, NSW, Australia.'}]",Midwifery,['10.1016/j.midw.2020.102766']
2037,32527270,Family-centeredness of childhood obesity interventions: psychometrics & outcomes of the family-centered care assessment tool.,"BACKGROUND


Incorporating family-centered care principles into childhood obesity interventions is integral for improved clinical decision making, better follow-through, and more effective communication that leads to better outcomes and greater satisfaction with services. The purpose of this study is to evaluate the psychometric properties of a modified version of the Family Centered-Care Assessment (mFCCA) tool and to assess the family-centeredness of two clinical-community childhood obesity interventions.
METHODS


Connect for Health was a randomized trial testing the comparative effectiveness of two interventions that enrolled 721 children, ages 2-12 years, with a body mass index (BMI) ≥ 85th percentile. The two arms were (1) enhanced primary care; and (2) enhanced primary care plus contextually-tailored, health coaching. At the end of the one-year intervention, the mFCCA was administered. We used Rasch analyses to assess the tool's psychometrics and examined differences between the groups using multiple linear regression.
RESULTS


629 parents completed the mFCCA resulting in an 87% response rate. The mean (SD) age of children was 8.0 (3.0) years. The exploratory factor analysis with 24 items all loaded onto a single factor. The Rasch modeling demonstrated good reliability as evidenced by the person separation reliability coefficient (0.99), and strong validity as evidenced by the range of item difficulty and overall model fit. The mean (SD, range) mFCCA score was 4.14 (0.85, 1-5). Compared to parents of children in the enhanced primary care arm, those whose children were in the enhanced primary care plus health coaching arm had higher mFCCA scores indicating greater perception of family-centeredness (β = 0.61 units [95% CI: 0.49, 0.73]).
CONCLUSIONS


Using the mFCCA which demonstrated good psychometric properties for the assessment of family-centered care among parents of children with obesity, we found that individualized health coaching is a family-centered approach to pediatric weight management.
TRIAL REGISTRATION


Clinicaltrials.gov NCT02124460.",2020,"Using the mFCCA which demonstrated good psychometric properties for the assessment of family-centered care among parents of children with obesity, we found that individualized health coaching is a family-centered approach to pediatric weight management.
","['enrolled 721 children, ages 2-12\u2009years, with a body mass index (BMI)\u2009≥\u200985th percentile', 'parents of children with obesity']","['modified version of the Family Centered-Care Assessment (mFCCA', 'primary care plus contextually-tailored, health coaching', 'mFCCA']","['mFCCA scores', 'mean (SD, range) mFCCA score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",721.0,0.0180158,"Using the mFCCA which demonstrated good psychometric properties for the assessment of family-centered care among parents of children with obesity, we found that individualized health coaching is a family-centered approach to pediatric weight management.
","[{'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Simione', 'Affiliation': 'Division of General Academic Pediatrics, Department of Pediatrics, MassGeneral Hospital for Children, 125 Nashua Street, Suite 860, Boston, MA, 02114, USA. msimione@mgh.harvard.edu.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Sharifi', 'Affiliation': 'Section of General Pediatrics, Department of Pediatrics, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Monica W', 'Initials': 'MW', 'LastName': 'Gerber', 'Affiliation': 'Division of General Academic Pediatrics, Department of Pediatrics, MassGeneral Hospital for Children, 125 Nashua Street, Suite 860, Boston, MA, 02114, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Marshall', 'Affiliation': 'Department of Pediatrics, Harvard Vanguard Medical Associates, Boston, MA, USA.'}, {'ForeName': 'Earlene', 'Initials': 'E', 'LastName': 'Avalon', 'Affiliation': 'Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Fiechtner', 'Affiliation': 'Division of General Academic Pediatrics, Department of Pediatrics, MassGeneral Hospital for Children, 125 Nashua Street, Suite 860, Boston, MA, 02114, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Horan', 'Affiliation': 'Division of General Academic Pediatrics, Department of Pediatrics, MassGeneral Hospital for Children, 125 Nashua Street, Suite 860, Boston, MA, 02114, USA.'}, {'ForeName': 'E John', 'Initials': 'EJ', 'LastName': 'Orav', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Skelton', 'Affiliation': 'Department of Pediatrics, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Elsie M', 'Initials': 'EM', 'LastName': 'Taveras', 'Affiliation': 'Division of General Academic Pediatrics, Department of Pediatrics, MassGeneral Hospital for Children, 125 Nashua Street, Suite 860, Boston, MA, 02114, USA.'}]",Health and quality of life outcomes,['10.1186/s12955-020-01431-y']
2038,32527283,Achieving blood pressure control targets in hypertensive patients of rural China - a pilot randomized trial.,"BACKGROUND


This study aimed to test the feasibility and titration methods used to achieve specific blood pressure (BP) control targets in hypertensive patients of rural China.
METHODS


A randomized, controlled, open-label trial was conducted in Rongcheng, China. We enrolled 105 hypertensive participants aged over 60 years, and who had no history of stroke or cardiovascular disease. The patients were randomly assigned to one of three systolic-BP target groups: standard: 140 to < 150 mmHg; moderately intensive: 130 to < 140 mmHg; and intensive: < 130 mmHg. The patients were followed for 6 months.
DISCUSSION


The optimal target for systolic blood pressure (SBP) lowering is still uncertain worldwide and such information is critically needed, especially in China. However, in China the rates of awareness, treatment and control are only 46.9%, 40.7%, and 15.3%, respectively. It is challenging to achieve BP control in the real world and it is very important to develop population-specific BP-control protocols that fully consider the population's characteristics, such as age, sex, socio-economic status, compliance with medication, education level, and lifestyle. This randomized trial showed the feasibility and safety of the titration protocol to achieve desirable SBP targets (< 150, < 140, and < 130 mmHg) in a sample of rural, Chinese hypertensive patients. The three BP target groups had similar baseline characteristics. After 6 months of treatment, the mean SBP measured at an office visit was 137.2 mmHg, 131.1 mmHg, and 124.2 mmHg, respectively, in the three groups. Home BP and central aortic BP measurements were also obtained. At 6 months, home BP measurements (2 h after drug administration) showed a mean SBP of 130.9 mmHg in the standard group, 124.9 mmHg in the moderately intensive group, and 119.7 mmHg in the intensive group. No serious adverse events were recorded over the 6-month study period. Rates of adverse events, including dry cough, palpitations, and arthralgia, were low and showed no significant differences between the three groups. This trial provided real-world experience and laid the foundation for a future, large-scale, BP target study.
TRIAL REGISTRATION


Feasibility Study of the Intensive Systolic Blood Pressure Control; ClinicalTrials.gov, ID: NCT02817503. Registered retrospectively on 29 June 2016.",2020,"Rates of adverse events, including dry cough, palpitations, and arthralgia, were low and showed no significant differences between the three groups.","['105 hypertensive participants aged over 60\u2009years, and who had no history of stroke or cardiovascular disease', 'hypertensive patients of rural China', 'Chinese hypertensive patients', 'hypertensive patients of rural China ']",['systolic-BP target groups: standard: 140 to\u2009<\u2009150\u2009mmHg; moderately intensive: 130 to\u2009<\u2009140\u2009mmHg; and intensive: <\u2009130\u2009mmHg'],"['Rates of adverse events, including dry cough, palpitations, and arthralgia', 'Home BP and central aortic BP measurements', 'mean SBP', 'specific blood pressure (BP) control targets', 'serious adverse events', 'blood pressure control targets', 'home BP measurements']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4319552', 'cui_str': '130'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0850149', 'cui_str': 'Dry cough'}, {'cui': 'C0030252', 'cui_str': 'Palpitations'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0456180', 'cui_str': 'Aortic pressure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}]",105.0,0.0519592,"Rates of adverse events, including dry cough, palpitations, and arthralgia, were low and showed no significant differences between the three groups.","[{'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Lishun', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Advanced Innovation Center for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Advanced Innovation Center for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Huihui', 'Initials': 'H', 'LastName': 'Bao', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Xianhui', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'National Clinical Research Study Center for Kidney Disease, State Key Laboratory of Organ Failure Research, Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Yanqing', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Qinghua', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Chonglei', 'Initials': 'C', 'LastName': 'Bi', 'Affiliation': 'Prevention and Control Office of Chronic Disease in Rongcheng, Rongcheng, Shangdong, China.'}, {'ForeName': 'Aiping', 'Initials': 'A', 'LastName': 'Yue', 'Affiliation': 'Disease Control and Prevention Center, Rongcheng, Shandong, China.'}, {'ForeName': 'Chongqian', 'Initials': 'C', 'LastName': 'Fang', 'Affiliation': ""People's Hospital of Rongcheng, Rongcheng, Shandong, China.""}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'Health and Family Planning Commission, Rongcheng, Shandong, China.'}, {'ForeName': 'Yimin', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Department of Pharmacy, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Genfu', 'Initials': 'G', 'LastName': 'Tang', 'Affiliation': 'Health Management College, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Binyan', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Institute of Biomedicine, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Xiping', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'National Clinical Research Study Center for Kidney Disease, State Key Laboratory of Organ Failure Research, Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Centers for Metabolic Disease Research, Temple University School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Gianfranco', 'Initials': 'G', 'LastName': 'Parati', 'Affiliation': 'Department of Cardiovascular, Neural and Metabolic Sciences, S. Luca Hospital, Milan, Italy.'}, {'ForeName': 'J David', 'Initials': 'JD', 'LastName': 'Spence', 'Affiliation': 'Stroke Prevention and Atherosclerosis Research Centre, Robarts Research Institute, Western University, London, ON, Canada.'}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Population, Family and Reproductive Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MA, USA.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huo', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, China. huoyong@263.net.cn.'}, {'ForeName': 'Guangliang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'College of Integrated Traditional Chinese and Western Medicine, Anhui University of Chinese Medicine, Hefei, China. chguangl@163.com.'}, {'ForeName': 'Xiaoshu', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Nanchang University, Nanchang, China. drchengxiaoshu@163.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04368-1']
2039,32527290,Less invasive surfactant administration versus endotracheal surfactant instillation followed by limited peak pressure ventilation in preterm infants with respiratory distress syndrome in China: study protocol for a randomized controlled trial.,"BACKGROUND


Less invasive surfactant administration (LISA) is a way of giving surfactant without endotracheal intubation and has shown to be promising in reducing the incidence of bronchopulmonary dysplasia (BPD) in preterm infants. However, the mechanism underlying its beneficial effect and variations in the technique of administration may prevent its widespread use. This trial aims to evaluate the effects of two methods of surfactant administration, LISA or endotracheal surfactant administration followed by low peak pressure (LPPSA) ventilation, in preterm infants with respiratory distress syndrome (RDS).
METHODS


The LISA Or Low Peak Pressure trial is to be conducted in 14 tertiary neonatal intensive care units in China. A total of 600 preterm infants born with gestational age between 25 0/7  and 31 6/7  weeks and with a primary diagnosis of RDS will be involved in the study. Infants will be randomized to the LISA or LPPSA group when surfactant therapy is indicated. Primary outcomes include mortality, severity of bronchopulmonary dysplasia at 36 weeks of postmenstrual age (PMA), and mechanical ventilation (MV) in the first 72 h of life. Secondary outcomes include the days of MV, duration of all sorts of non-invasive respiratory support, fraction of inspired oxygen, oxygen saturation before and after surfactant administration, and time required to perform the procedure for surfactant administration. The incidence of comorbidities, including retinopathy of prematurity (ROP), necrotizing enterocolitis (NEC), intraventricular hemorrhage (IVH), hemodynamically significant patent ductus arteriosus (hsPDA), pneumothorax, and massive pulmonary hemorrhage within 48 h of surfactant administration, and the failure rates of each technique will be determined.
DISCUSSION


Data from recent systematic review and meta-analysis have suggested a possible improvement in outcomes of preterm infants with RDS by the LISA technique. However, robust evidence is lacking. Why LISA plays a potential role in reducing respiratory morbidity, mainly BPD in preterm infants, remains unclear. The possible explanations are the active and uninterrupted delivery of continuous positive airway pressure during the LISA procedure and the avoidance of complications caused by intubation and relatively high pressure/volume ventilation following surfactant administration. We hypothesized that LISA's effectiveness lies mainly in avoiding relatively high-pressure positive ventilation immediately following surfactant administration. Thus, this multicenter randomized controlled trial will focus on issues of endotracheal intubation and the pressure/volume used during conventional surfactant administration. The effectiveness, safety and comorbidities of preterm infants following LISA or LPPSA will be evaluated.
TRIAL REGISTRATION


Chinese Clinical Trial Registry: ChiCTR1900020970. Registered on 23 January 2019.",2020,"The incidence of comorbidities, including retinopathy of prematurity (ROP), necrotizing enterocolitis (NEC), intraventricular hemorrhage (IVH), hemodynamically significant patent ductus arteriosus (hsPDA), pneumothorax, and massive pulmonary hemorrhage within 48 h of surfactant administration, and the failure rates of each technique will be determined.
","['preterm infants with respiratory distress syndrome (RDS', 'preterm infants', 'preterm infants with RDS by the LISA technique', '14 tertiary neonatal intensive care units in China', '600 preterm infants born with gestational age between 25 0/7  and 31 6/7  weeks and with a primary diagnosis of RDS will be involved in the study', 'preterm infants with respiratory distress syndrome in China']","['endotracheal intubation', 'surfactant administration, LISA or endotracheal surfactant administration followed by low peak pressure (LPPSA) ventilation', 'invasive surfactant administration (LISA', 'LISA or LPPSA', 'endotracheal surfactant instillation']","['days of MV, duration of all sorts of non-invasive respiratory support, fraction of inspired oxygen, oxygen saturation before and after surfactant administration, and time required to perform the procedure for surfactant administration', 'incidence of comorbidities, including retinopathy of prematurity (ROP), necrotizing enterocolitis (NEC), intraventricular hemorrhage (IVH), hemodynamically significant patent ductus arteriosus (hsPDA), pneumothorax, and massive pulmonary hemorrhage within 48\u2009h of surfactant administration, and the failure rates of each technique will be determined', 'mortality, severity of bronchopulmonary dysplasia at 36\u2009weeks of postmenstrual age (PMA), and mechanical ventilation (MV) in the first 72\u2009h of life', 'peak pressure ventilation', 'effectiveness, safety and comorbidities']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C1522653', 'cui_str': 'Intratracheal route'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0445174', 'cui_str': 'Peak pressure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0035344', 'cui_str': 'Retinopathy of prematurity'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0151701', 'cui_str': 'Pulmonary hemorrhage'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0445174', 'cui_str': 'Peak pressure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",600.0,0.223819,"The incidence of comorbidities, including retinopathy of prematurity (ROP), necrotizing enterocolitis (NEC), intraventricular hemorrhage (IVH), hemodynamically significant patent ductus arteriosus (hsPDA), pneumothorax, and massive pulmonary hemorrhage within 48 h of surfactant administration, and the failure rates of each technique will be determined.
","[{'ForeName': 'Jiajun', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': ""Women's Hospital, Zhejiang University, School of Medicine, Hangzhou, 310006, China. jiajunzhu@zju.edu.cn.""}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Bao', 'Affiliation': ""Women's Hospital, Zhejiang University, School of Medicine, Hangzhou, 310006, China.""}, {'ForeName': 'Lizhong', 'Initials': 'L', 'LastName': 'Du', 'Affiliation': ""The Children's Hospital, Zhejiang University, School of Medicine, Hangzhou, 310052, China. dulizhong@zju.edu.cn.""}, {'ForeName': 'Huafei', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Jiaxing Maternity and Child Health Care Hospital, Jiaxing, 314051, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Lv', 'Affiliation': 'Ningbo Maternal and Children Hospital, Ningbo, 315012, China.'}, {'ForeName': 'Yejun', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Shao Xing Maternity and Child Health Care Hospital, Shaoxing, 312000, China.'}, {'ForeName': 'Yuxuan', 'Initials': 'Y', 'LastName': 'Dai', 'Affiliation': 'Central Hospital of Jinhua, Jinghua, 321000, China.'}, {'ForeName': 'Zhijun', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Boai Hospital of Zhongshan, Zhongshan, 528400, China.'}, {'ForeName': 'Jingyun', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Gansu Provincial Maternity and Child-Care Hospital, Lanzhou, 730050, China.'}, {'ForeName': 'Yongyan', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Shengjing Hospital of China Medical University, Shenyang, 110004, China.'}, {'ForeName': 'Chuangzhong', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Affiliated Shenzhen Maternity& Child Healthcare Hospital, Southern Medical University, Shenzhen, 518028, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Mei', 'Affiliation': 'Affiliated Hospital of Inner Mongolia Medical University, Hohhot, 010050, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': ""Yan'an University Affiliated Hospital, Yan'an, 716000, China.""}, {'ForeName': 'Yanhui', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Chongqing Health Center for Women and Children, Chongqing, 400021, China.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': ""Linyi People's Hospital, Linyi, 276003, China.""}]",Trials,['10.1186/s13063-020-04390-3']
2040,32527322,Enhanced care planning and clinical-community linkages versus usual care to address basic needs of patients with multiple chronic conditions: a clinician-level randomized controlled trial.,"BACKGROUND


Many patients with poorly controlled multiple chronic conditions (MCC) also have unhealthy behaviors, mental health challenges, and unmet social needs. Medical management of MCC may have limited benefit if patients are struggling to address their basic life needs. Health systems and communities increasingly recognize the need to address these issues and are experimenting with and investing in new models for connecting patients with needed services. Yet primary care clinicians, whose regular contact with patients makes them more familiar with patients' needs, are often not included in these systems.
METHODS


We are starting a clinician-level cluster-randomized controlled trial to evaluate how primary care clinicians can participate in these community and hospital solutions and whether doing so is effective in controlling MCC. Sixty clinicians in the Virginia Ambulatory Care Outcomes Research Network will be matched by age and sex and randomized to usual care (control condition) or enhanced care planning with clinical-community linkage support (intervention). From the electronic health record we will identify all patients with MCC, including cardiovascular disease or risks, diabetes, obesity, or depression. A baseline assessment will be mailed to up to 50 randomly selected patients for each clinician (3000 total). Ten respondents per clinician (600 patients total) with uncontrolled MCC will be randomly selected for study inclusion, with oversampling of minorities. The intervention includes two components. First, we will use an enhanced care planning tool, My Own Health Report (MOHR), to screen patients for health behavior, mental health, and social needs. Patients will be supported by a patient navigator, who will help patients prioritize needs, create care plans, and write a personal narrative to guide the care team. Patients will update care plans every 1 to 2 weeks. Second, we will create community-clinical linkage to help address patients' needs. The linkage will include community resource registries, personnel to span settings (patient navigators and a community health worker), and care team coordination across team members through MOHR.
DISCUSSION


This study will help inform efforts by primary care clinicians to help address unhealthy behaviors, mental health needs, and social risks as a strategy to better control MCC.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03885401. Registered on 19 September 2019.",2020,Health systems and communities increasingly recognize the need to address these issues and are experimenting with and investing in new models for connecting patients with needed services.,"['patients with poorly controlled multiple chronic conditions (MCC', 'connecting patients with needed services', 'patients with multiple chronic conditions', '50 randomly selected patients for each clinician (3000 total', 'Ten respondents per clinician (600 patients total) with uncontrolled MCC will be randomly selected for study inclusion, with oversampling of minorities']","['usual care (control condition) or enhanced care planning with clinical-community linkage support (intervention', 'MCC']","['cardiovascular disease or risks, diabetes, obesity, or depression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C3266262', 'cui_str': 'Multiple chronic diseases'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0178916', 'cui_str': 'Care plan'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3266262', 'cui_str': 'Multiple chronic diseases'}]","[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",50.0,0.0732347,Health systems and communities increasingly recognize the need to address these issues and are experimenting with and investing in new models for connecting patients with needed services.,"[{'ForeName': 'Alex H', 'Initials': 'AH', 'LastName': 'Krist', 'Affiliation': 'Department of Family Medicine and Population Health, Virginia Commonwealth University, One Capital Square Room 631, 830 East Main St, Richmond, VA, 23219, USA. ahkrist@vcu.edu.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': ""O'Loughlin"", 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Steven H', 'Initials': 'SH', 'LastName': 'Woolf', 'Affiliation': 'Department of Family Medicine and Population Health, Virginia Commonwealth University, One Capital Square Room 631, 830 East Main St, Richmond, VA, 23219, USA.'}, {'ForeName': 'Roy T', 'Initials': 'RT', 'LastName': 'Sabo', 'Affiliation': 'Department of Family Medicine and Population Health, Virginia Commonwealth University, One Capital Square Room 631, 830 East Main St, Richmond, VA, 23219, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hinesley', 'Affiliation': 'Department of Family Medicine and Population Health, Virginia Commonwealth University, One Capital Square Room 631, 830 East Main St, Richmond, VA, 23219, USA.'}, {'ForeName': 'Anton J', 'Initials': 'AJ', 'LastName': 'Kuzel', 'Affiliation': 'Department of Family Medicine and Population Health, Virginia Commonwealth University, One Capital Square Room 631, 830 East Main St, Richmond, VA, 23219, USA.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Rybarczyk', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Paulette Lail', 'Initials': 'PL', 'LastName': 'Kashiri', 'Affiliation': 'Department of Family Medicine and Population Health, Virginia Commonwealth University, One Capital Square Room 631, 830 East Main St, Richmond, VA, 23219, USA.'}, {'ForeName': 'E Marshall', 'Initials': 'EM', 'LastName': 'Brooks', 'Affiliation': 'Department of Family Medicine and Population Health, Virginia Commonwealth University, One Capital Square Room 631, 830 East Main St, Richmond, VA, 23219, USA.'}, {'ForeName': 'Russel E', 'Initials': 'RE', 'LastName': 'Glasgow', 'Affiliation': 'Department of Family Medicine, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Amy G', 'Initials': 'AG', 'LastName': 'Huebschmann', 'Affiliation': 'Department of Family Medicine, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Winston R', 'Initials': 'WR', 'LastName': 'Liaw', 'Affiliation': 'Department of Health Systems and Population Health Sciences, University of Houston College of Medicine, Houston, TX, USA.'}]",Trials,['10.1186/s13063-020-04463-3']
2041,32497956,Metacognitions about problematic Smartphone use: Development of a self-report measure.,"BACKGROUND AND AIMS


Recent research has suggested that metacognitions may play a role across the spectrum of addictive behaviours, including problematic use of technological devices. Metacognitions associated with problematic Smartphone use (PSU) have been scarcely investigated and measures to assess these beliefs are not yet available. The goal of the present study was: (i) to develop the first self-report scale of metacognitions about Smartphone use; and (ii) to investigate its predictive validity with respect to PSU.
METHODS


Twenty-four items concerning positive and negative metacognitions about PSU were framed and administered to a community sample of 701 Smartphone users (F = 66.2%; mean age: 28.08 ± 9.81; age range: 15-70). An exploratory factor analysis was first performed in a randomly allocated subsample of 350 participants. A confirmative factor analysis was then computed on a second subsample of 351 participants to test the fit of the factor structure identified.
RESULTS


Findings revealed a 3-factor solution consisting of positive metacognitions concerning emotional and cognitive regulation, positive metacognitions concerning social advantages, and negative metacognitions about uncontrollability and cognitive harm of Smartphone use. Regression analysis showed that all the Metacognitions about Smartphone Use Questionnaire (MSUQ) factors were significantly associated to PSU independently of anxiety and depressive symptoms.
CONCLUSIONS


The MSUQ might be a promising self-report measure and further support research into the role of metacognition in technological addictions.",2020,Regression analysis showed that all the Metacognitions about Smartphone Use Questionnaire,"['350 participants', 'Twenty-four items concerning positive and negative metacognitions about PSU were framed and administered to a community sample of 701 Smartphone users (F\xa0=\xa066.2%; mean age: 28.08\xa0±\xa09.81; age range: 15-70']",[],"['anxiety and depressive symptoms', 'Metacognitions about Smartphone Use Questionnaire']","[{'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0589513', 'cui_str': 'Metacognition'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0589513', 'cui_str': 'Metacognition'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",701.0,0.0366231,Regression analysis showed that all the Metacognitions about Smartphone Use Questionnaire,"[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Casale', 'Affiliation': 'Department of Health Sciences, Psychology and Psychiatry Unit, University of Florence, via di San Salvi 12, Florence, Italy. Electronic address: silvia.casale@unifi.it.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Caponi', 'Affiliation': 'Department of Health Sciences, Psychology and Psychiatry Unit, University of Florence, via di San Salvi 12, Florence, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Fioravanti', 'Affiliation': 'Department of Health Sciences, Psychology and Psychiatry Unit, University of Florence, via di San Salvi 12, Florence, Italy.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106484']
2042,32497489,Tranexamic Acid Is Associated With Improved Operative Field in Orthognathic Surgery.,"PURPOSE


In the past, both tranexamic acid and dexmedetomidine have been used separately to decrease intraoperative blood loss during orthognathic surgery. However, their combined use in the same setting has never been prospectively evaluated. The present study was conducted to evaluate the effect of tranexamic acid on operative field visibility and blood loss during orthognathic surgery after dexmedetomidine-induced hypotensive anesthesia.
PATIENTS AND METHODS


The present prospective, randomized clinical trial included patients who had undergone orthognathic surgery under general anesthesia. The patients were divided into 2 groups. The dexmedetomidine and tranexamic (DT) group received an intravenous bolus of tranexamic acid (15 mg/kg) and intravenous dexmedetomidine (0.25 to 0.7 μg/kg/hr) as maintenance infusion. The dexmedetomidine (DS) group received only intravenous dexmedetomidine at the same dosage. All the patients received a bolus dose of intravenous dexmedetomidine (1 μg/kg) before the start of anesthesia induction. The operating surgeon rated the quality of the surgical visual field every 15 minutes using the Fromme ordinal scale. Intraoperative blood loss was estimated using the modified gross formula. The operating surgeon's satisfaction was assessed using a Likert scale. Data were analyzed using SPSS, version 22.0 (IBM Corp, Armonk, NY). Kolmogorov-Smirnov tests were used to assess the normality of the measured data, and categorical variables were analyzed using the χ 2  or Fischer exact test.
RESULTS


The study sample included 36 patients, with a mean age of 23.67 ± 11.298 years in the DS group and 20.28 ± 3.286 years in the DT group. Of the patients in the DS and DT groups, 66.66 and 61.11% were male, respectively. No statistically significant differences were found in the baseline characteristics between the 2 treatment groups. The surgeon reported a significantly better surgical visual field in the DT group compared with that in the DS group (P = .001). Also, the intraoperative blood loss significantly less in the DT group (231.11 ± 137.64 mL vs 360.17 ± 187.86 mL; P = .025).
CONCLUSIONS


Tranexamic acid improved surgical field visibility and reduced intraoperative blood loss when administered in conjunction with dexmedetomidine during orthognathic surgery under controlled hypotensive anesthesia.",2020,"Also, the intraoperative blood loss significantly less in the DT group (231.11 ± 137.64 ","['orthognathic surgery after dexmedetomidine-induced hypotensive anesthesia', '36 patients, with a mean age of 23.67\xa0±\xa011.298\xa0years in the DS group and 20.28\xa0±\xa03.286\xa0years in the DT group', 'Orthognathic Surgery', 'patients who had undergone orthognathic surgery under general anesthesia']","['dexmedetomidine (DS', 'tranexamic acid and dexmedetomidine', 'Tranexamic Acid', 'dexmedetomidine and tranexamic (DT', 'tranexamic acid', 'dexmedetomidine', 'Tranexamic acid']","['operative field visibility and blood loss', 'surgical field visibility and reduced intraoperative blood loss', 'surgical visual field', 'intraoperative blood loss', 'Intraoperative blood loss']","[{'cui': 'C0185624', 'cui_str': 'Orthognathic Surgery'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}]",36.0,0.0629391,"Also, the intraoperative blood loss significantly less in the DT group (231.11 ± 137.64 ","[{'ForeName': 'Harjinder', 'Initials': 'H', 'LastName': 'Sharma', 'Affiliation': 'Junior Resident, Department of Anesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Arora', 'Affiliation': 'Professor, Department of Anesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Bhatia', 'Affiliation': 'Additional Professor, Department of Anesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India. Electronic address: nidhi.bhatia75@gmail.com.'}, {'ForeName': 'Vidya', 'Initials': 'V', 'LastName': 'Rattan', 'Affiliation': 'Additional Professor, Department of Anesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Sethi', 'Affiliation': 'Professor, Unit of Oral and Maxillofacial Surgery, Oral Health Sciences Centre, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.04.037']
2043,32502705,The efficacy of transversus abdominis plane block with or without dexmedetomidine for postoperative analgesia in renal transplantation. A randomized controlled trial.,"BACKGROUND


Current options for effective postoperative analgesia after renal transplantation are limited, due to altered renal clearance and the risk of renal damage. This study compared the analgesic effect of the transversus abdominis plane block, with or without dexmedetomidine, in renal transplant recipients.
MATERIALS AND METHODS


This prospective randomized double-blinded clinical trial was performed from November 2014 to March 2017. Patients were randomly divided into group C (morphine intravenous patient-controlled analgesia), group R (morphine intravenous patient-controlled analgesia and transversus abdominis plane block), and group RD (morphine intravenous patient-controlled analgesia and transversus abdominis plane block with 1 μg/kg dexmedetomidine). Morphine consumption, time to first request for analgesia, pain, sedation, nausea, vomiting, respiratory depression, and bradycardia were measured at 2, 4, 6, 12 and 24 h after surgery.
RESULTS


The visual analogue pain score in group C was the highest among the three groups at the 2nd and 4th hour. Morphine consumption was the highest in group C at all assessed time intervals (p < 0.01). By the 12th hour and 24th hour, morphine consumption (calculated by time interval) was the lowest in group RD (p < 0.05), while no statistical difference was found between groups C and R. The average time to first request of analgesia was the longest and shortest in group RD and group C, respectively (p < 0.01). The overall incidence of nausea and vomiting was the highest in group C (p < 0.05).
CONCLUSIONS


The transversus abdominis plane block reduced morphine consumption in the first 24 h following renal transplantation, and the addition of dexmedetomidine provided a more effective analgesic effect.",2020,The visual analogue pain score in group C was the highest among the three groups at the 2nd and 4th hour.,"['renal transplant recipients', 'November 2014 to March 2017', 'renal transplantation']","['C (morphine intravenous patient-controlled analgesia), group R (morphine intravenous patient-controlled analgesia and transversus abdominis plane block), and group RD (morphine intravenous patient-controlled analgesia and transversus abdominis plane block with 1 μg/kg dexmedetomidine', 'transversus abdominis plane block with or without dexmedetomidine', 'dexmedetomidine', 'transversus abdominis plane block, with or without dexmedetomidine']","['visual analogue pain score', 'Morphine consumption, time to first request for analgesia, pain, sedation, nausea, vomiting, respiratory depression, and bradycardia', 'nausea and vomiting', 'morphine consumption', 'effective analgesic effect', 'Morphine consumption', 'average time to first request of analgesia']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0441852', 'cui_str': 'Group R'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0686900', 'cui_str': 'Request for'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C1272683', 'cui_str': 'Requested'}]",,0.113764,The visual analogue pain score in group C was the highest among the three groups at the 2nd and 4th hour.,"[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, No.58, Zhongshan 2nd Road, 510080, Guangzhou, China.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Anesthesiology, Zhongshan Ophthalmic Center, Sun Yat-sen University, No.54 Xianlie South Road, 510060, Guangzhou, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, No.58, Zhongshan 2nd Road, 510080, Guangzhou, China.'}, {'ForeName': 'Hufei', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, No.58, Zhongshan 2nd Road, 510080, Guangzhou, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, No.58, Zhongshan 2nd Road, 510080, Guangzhou, China.'}, {'ForeName': 'Yunsheng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, No.58, Zhongshan 2nd Road, 510080, Guangzhou, China. Electronic address: mysjz1@163.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.05.073']
2044,32503866,Telephone health coaching with exercise monitoring using wearable activity trackers (TeGeCoach) for improving walking impairment in peripheral artery disease: study protocol for a randomised controlled trial and economic evaluation.,"INTRODUCTION


Peripheral artery disease (PAD) is the third most prevalent cardiovascular disease worldwide, with smoking and diabetes being the strongest risk factors. The most prominent symptom is leg pain while walking, known as intermittent claudication. To improve mobility, first-line treatment for intermittent claudication is supervised exercise programmes, but these remain largely unavailable and economically impractical, which has led to the development of structured home-based exercise programmes. This trial aims to determine the effectiveness and cost advantage of TeGeCoach, a 12-month long home-based exercise programme, compared with usual care of PAD. It is hypothesised that TeGeCoach improves walking impairment and lowers the need of health care resources that are spent on patients with PAD.
METHODS AND ANALYSIS


The investigators conduct a prospective, pragmatic randomised controlled clinical trial in a health insurance setting. 1760 patients diagnosed with PAD at Fontaine stage II are randomly assigned to either TeGeCoach or care-as-usual. TeGeCoach consists of telemonitored intermittent walking exercise with medical supervision by a physician and telephone health coaching. Participants allocated to the usual care group receive information leaflets and can access supervised exercise programmes, physical therapy and a variety of programmes for promoting a healthy lifestyle. The primary outcome is patient reported walking ability based on the Walking Impairment Questionnaire. Secondary outcome measures include quality of life, health literacy and health behaviour. Claims data are used to collect total health care costs, healthcare resource use and (severe) adverse events. Outcomes are measured at baseline, 12 and 24 months.
ETHICS AND DISSEMINATION


Ethical approval has been obtained from the Medical Association Hamburg. Findings are disseminated through peer-reviewed journals, reports to the funding body, conference presentations and media press releases. Data from this trial are made available to the public and researchers upon reasonable request.NCT03496948 (www.clinicaltrials.gov), Pre-results.",2020,"Participants allocated to the usual care group receive information leaflets and can access supervised exercise programmes, physical therapy and a variety of programmes for promoting a healthy lifestyle.","['peripheral artery disease', 'patients with PAD', '1760 patients diagnosed with PAD at Fontaine stage II']","['Telephone health coaching with exercise monitoring using wearable activity trackers (TeGeCoach', 'usual care group receive information leaflets and can access supervised exercise programmes, physical therapy and a variety of programmes for promoting a healthy lifestyle', 'TeGeCoach or care-as-usual', 'TeGeCoach']","['walking ability based on the Walking Impairment Questionnaire', 'quality of life, health literacy and health behaviour', 'walking impairment']","[{'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C2317129', 'cui_str': 'Health coach'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}]","[{'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]",1760.0,0.109017,"Participants allocated to the usual care group receive information leaflets and can access supervised exercise programmes, physical therapy and a variety of programmes for promoting a healthy lifestyle.","[{'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Rezvani', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Hamburg, Germany f.rezvani@uke.de.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Heider', 'Affiliation': 'Department of Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf, Hamburg, Hamburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Härter', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Hamburg, Germany.'}, {'ForeName': 'Hans-Helmut', 'Initials': 'HH', 'LastName': 'König', 'Affiliation': 'Department of Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf, Hamburg, Hamburg, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Bienert', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Brinkmann', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Herbarth', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Kramer', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Steinisch', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Freudenstein', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Terhalle', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Grosse', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Bock', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Posselt', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Beutel', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Reif', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Kirchhoff', 'Affiliation': 'mhplus Krankenkasse, Nürnberg, Bayern, Germany.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Neuschwander', 'Affiliation': 'mhplus Krankenkasse, Nürnberg, Bayern, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Löffler', 'Affiliation': 'mhplus Krankenkasse, Nürnberg, Bayern, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Brunner', 'Affiliation': 'mhplus Krankenkasse, Nürnberg, Bayern, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Dickmeis', 'Affiliation': 'IEM GmbH, Stolberg, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Heidenthal', 'Affiliation': 'IEM GmbH, Stolberg, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Schmitz', 'Affiliation': 'Philips Germany GmbH, Hamburg, Hamburg, Germany.'}, {'ForeName': 'Daniela Patricia', 'Initials': 'DP', 'LastName': 'Chase', 'Affiliation': 'Philips Germany GmbH, Hamburg, Hamburg, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Seelenmeyer', 'Affiliation': 'Dr Margarete Fischer Bosch Institute of Clinical Pharmacology, Stuttgart, Baden-Württemberg, Germany.'}, {'ForeName': 'Mark Dominik', 'Initials': 'MD', 'LastName': 'Alscher', 'Affiliation': 'Dr Margarete Fischer Bosch Institute of Clinical Pharmacology, Stuttgart, Baden-Württemberg, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Tegtbur', 'Affiliation': 'Department of Sports Medicine, Hannover Medical School, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Dirmaier', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Hamburg, Germany.'}]",BMJ open,['10.1136/bmjopen-2019-032146']
2045,32503867,"Study protocol for an international, multicentre stepped-wedge cluster randomised trial to evaluate the impact of a digital antimicrobial stewardship smartphone application.","INTRODUCTION


With the widespread use of electronic health records and handheld electronic devices in hospitals, informatics-based antimicrobial stewardship interventions hold great promise as tools to promote appropriate antimicrobial drug prescribing. However, more research is needed to evaluate their optimal design and impact on quantity and quality of antimicrobial prescribing.
METHODS AND ANALYSIS


Use of smartphone-based digital stewardship applications (apps) with local guideline directed empirical antimicrobial use by physicians will be compared with antimicrobial prescription as per usual as primary outcome in three hospitals in the Netherlands, Sweden and Switzerland. Secondary outcomes will include antimicrobial use metrics, clinical and process outcomes. A multicentre stepped-wedge cluster randomised trial will randomise entities defined as wards or specialty regarding time of introduction of the intervention. We will include 36 hospital entities with seven measurement periods in which the primary outcome will be measured in 15 participating patients per time period per cluster. At participating wards, patients of at least 18 years of age using antimicrobials will be included. After a baseline period of 2-week measurements, six periods of 4 weeks will follow in which the intervention is introduced in 6 wards (in three hospitals) until all 36 wards have implemented the intervention. Thereafter, we allow use of the app by everyone, and evaluate the sustainability of the app use 6 months later.
ETHICS AND DISSEMINATION


This protocol has been approved by the institutional review board of each participating centre. Results will be disseminated via media, to healthcare professionals via professional training and meetings and to researchers via conferences and publications.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov registry (NCT03793946). Stage; pre-results.",2020,"METHODS AND ANALYSIS


Use of smartphone-based digital stewardship applications (apps) with local guideline directed empirical antimicrobial use by physicians will be compared with antimicrobial prescription as per usual as primary outcome in three hospitals in the Netherlands, Sweden and Switzerland.","['hospitals', 'At participating wards, patients of at least 18 years of age using antimicrobials will be included']","['smartphone-based digital stewardship applications', 'digital antimicrobial stewardship smartphone application']","['antimicrobial use metrics, clinical and process outcomes']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C4505099', 'cui_str': 'Antimicrobial Stewardship'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",15.0,0.275037,"METHODS AND ANALYSIS


Use of smartphone-based digital stewardship applications (apps) with local guideline directed empirical antimicrobial use by physicians will be compared with antimicrobial prescription as per usual as primary outcome in three hospitals in the Netherlands, Sweden and Switzerland.","[{'ForeName': 'R I', 'Initials': 'RI', 'LastName': 'Helou', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Gaud', 'Initials': 'G', 'LastName': 'Catho', 'Affiliation': 'Department of Infectious Diseases, Hopitaux Universitaires de Geneve, Geneva, Switzerland.'}, {'ForeName': 'Annabel', 'Initials': 'A', 'LastName': 'Peyravi Latif', 'Affiliation': 'Department of Infectious Diseases, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Mouton', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hulscher', 'Affiliation': 'Scientific Center for Quality of Healthcare (IQ Healthcare), Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Teerenstra', 'Affiliation': 'Department for Health Evidence, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Conly', 'Affiliation': 'Department of Medicine, University of Calgary and Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Benedikt D', 'Initials': 'BD', 'LastName': 'Huttner', 'Affiliation': 'Department of Infectious Diseases, Hopitaux Universitaires de Geneve, Geneva, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Tängdén', 'Affiliation': 'Department of Infectious Diseases, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Verbon', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, Erasmus Medical Center, Rotterdam, The Netherlands a.verbon@erasmusmc.nl.'}]",BMJ open,['10.1136/bmjopen-2019-033640']
2046,32506975,Nintedanib for the treatment of systemic sclerosis-associated interstitial lung disease.,"INTRODUCTION


Interstitial lung disease (ILD) is a leading cause of death in patients with systemic sclerosis (SSc). Nonspecific immunosuppressants have been the first-line treatment for SSc-associated ILD (SSc-ILD). Nintedanib, an oral triple kinase inhibitor targeting profibrotic pathways, has been employed for the treatment of idiopathic pulmonary fibrosis and has recently received marketing approval in the United States and Japan, based on the results of a placebo-controlled randomized controlled trial. In this clinical trial, nintedanib delayed the progression of SSc-ILD compared with placebo.
AREAS COVERED


This review covers current pharmacotherapies for SSc-ILD, drug profiles of nintedanib, and efficacy and safety profiles of nintedanib in patients with idiopathic pulmonary fibrosis and SSc-ILD observed in randomized controlled trails.
EXPERT OPINION


Currently, we have two treatment options for SSc-ILD, i.e., immunosuppressants and antifibrotic agents. However, appropriate utilization of antifibrotic agents in clinical practice remains challenging, i.e., in which cases they are to be used, timing of use, how to use them properly, and whether in combination with immunosuppressants.",2020,"In this clinical trial, Nintedanib delayed the progression of SSc-ILD compared with placebo.
","['systemic sclerosis-associated interstitial lung disease', 'patients with systemic sclerosis (SSc', 'patients with idiopathic pulmonary fibrosis and SSc-ILD']","['Nintedanib', 'placebo']",[],"[{'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}]","[{'cui': 'C2930789', 'cui_str': 'nintedanib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0547629,"In this clinical trial, Nintedanib delayed the progression of SSc-ILD compared with placebo.
","[{'ForeName': 'Yoshioki', 'Initials': 'Y', 'LastName': 'Yamasaki', 'Affiliation': 'Department of Allergy and Rheumatology, Nippon Medical School , Tokyo, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Kuwana', 'Affiliation': 'Department of Allergy and Rheumatology, Nippon Medical School , Tokyo, Japan.'}]",Expert review of clinical immunology,['10.1080/1744666X.2020.1777857']
2047,32505866,"Compared to Facebook, Instagram use causes more appearance comparison and lower body satisfaction in college women.","The current experiment tested the effect of social media use on college women's appearance comparisons, mood, and body satisfaction. We randomly assigned 308 undergraduate women (aged 18-26) to use Facebook, use Instagram, or play a matching game (the control condition) on an iPad for seven minutes. Compared to the Facebook condition, Instagram users retrospectively reported spending more time viewing images or videos containing people. Participants in both the Facebook and Instagram conditions also retrospectively reported engaging in more appearance comparisons relative to those in the control condition, but Instagram users reported significantly more appearance comparisons than those in the Facebook condition. Those who used Instagram, but not Facebook, showed decreased body satisfaction, decreased positive affect, and increased negative affect. Results are consistent with previous research suggesting social media use influences body satisfaction and social comparison, and that Instagram may be a particularly harmful platform when it comes to body image because of its focus on photos over text.",2020,"Those who used Instagram, but not Facebook, showed decreased body satisfaction, decreased positive affect, and increased negative affect.","[""college women's"", '308 undergraduate women (aged 18-26) to use', 'college women']","['Facebook, use Instagram, or play a matching game (the control condition']","['body satisfaction', 'appearance comparisons, mood, and body satisfaction']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",308.0,0.0383295,"Those who used Instagram, but not Facebook, showed decreased body satisfaction, decreased positive affect, and increased negative affect.","[{'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Engeln', 'Affiliation': 'Department of Psychology, Northwestern University, United States. Electronic address: rengeln@northwestern.edu.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Loach', 'Affiliation': 'Department of Psychology, Northwestern University, United States.'}, {'ForeName': 'Megan N', 'Initials': 'MN', 'LastName': 'Imundo', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, United States.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Zola', 'Affiliation': 'Oxford Internet Institute, University of Oxford, United Kingdom.'}]",Body image,['10.1016/j.bodyim.2020.04.007']
2048,32505867,Light-emitting-diode and Grass PS 33 xenon lamp photic stimulators are equivalent in the assessment of photosensitivity: Clinical and research implications.,"The assessment of the effect of photic stimulation is an integral component of an EEG exam and is especially important in patients referred for ascertained or suspected photosensitivity with or without a diagnosis of epilepsy. A positive test result relies on eliciting a specific abnormality defined as the ""photoparoxysmal response"". Reliability of this assessment is strongly influenced by technical and procedural variables, a critical one represented by the physical properties of the stimulators used. Established clinical norms are based on data acquired with the ""gold-standard"" Grass PS stimulators. These are no longer commercially available and have been replaced by stimulators using light emitting diode (LED) technology. To our knowledge no comparative study on their efficacy has been conducted. To address this gap, we recruited 39 patients aged 5-54 years, referred to two specialized centers with confirmed of suspected diagnosis of photosensitive epilepsy or generalized epilepsy with photosensitivity in a prospective randomized single-blind cross-over study to compare two commercially available LED-bases stimulation systems (FSA 10® and Lifeline® stimulators) against the Grass PS 33 xenon lamp device. Our findings indicate that the LED systems tested are equivalent to the Grass stimulator both in identifying the PPR in affected individuals.",2020,Our findings indicate that the LED systems tested are equivalent to the Grass stimulator both in identifying the PPR in affected individuals.,"['39 patients aged 5-54 years, referred to two specialized centers with confirmed of suspected diagnosis of photosensitive epilepsy or generalized epilepsy with photosensitivity', 'patients referred for ascertained or suspected photosensitivity with or without a diagnosis of epilepsy']","['Light-emitting-diode and Grass PS 33 xenon lamp photic stimulators', 'LED-bases stimulation systems (FSA 10® and Lifeline® stimulators) against the Grass PS 33 xenon lamp device', 'photic stimulation']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0393720', 'cui_str': 'Photogenic epilepsy'}, {'cui': 'C0014548', 'cui_str': 'Generalized epilepsy'}, {'cui': 'C0349506', 'cui_str': 'Photosensitivity'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0162676', 'cui_str': 'Enzyme-multiplied immunoassay technique'}, {'cui': 'C0018210', 'cui_str': 'Poaceae'}, {'cui': 'C0043339', 'cui_str': 'Xenon'}, {'cui': 'C0392223', 'cui_str': 'Lamp'}, {'cui': 'C0175727', 'cui_str': 'Stimulator'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0031734', 'cui_str': 'Photic stimulation'}]",[],39.0,0.0265254,Our findings indicate that the LED systems tested are equivalent to the Grass stimulator both in identifying the PPR in affected individuals.,"[{'ForeName': 'Dorothée', 'Initials': 'D', 'LastName': 'Kasteleijn-Nolst Trenité', 'Affiliation': 'Department of Neurosurgery and Epilepsy, University Medical Center Utrecht, Utrecht, the Netherlands; Nesmos Department, Faculty of Medicine and Psychology, Sapienza University, Roma, Italy.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Carr', 'Affiliation': ""Department of Clinical Neurophysiology, Birmingham Women's and Children's Hospital NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Checa-Ros', 'Affiliation': ""Department of Clinical Neurophysiology, Birmingham Women's and Children's Hospital NHS Foundation Trust, Birmingham, UK; School of Life and Health Sciences, Aston Neuroscience Institute, Aston University, Birmingham, UK; Department of Pediatrics, Faculty of Medicine, University of Granada, Spain.""}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Seri', 'Affiliation': ""Department of Clinical Neurophysiology, Birmingham Women's and Children's Hospital NHS Foundation Trust, Birmingham, UK; School of Life and Health Sciences, Aston Neuroscience Institute, Aston University, Birmingham, UK. Electronic address: s.seri@aston.ac.uk.""}]",Epilepsy research,['10.1016/j.eplepsyres.2020.106377']
2049,32512272,Durvalumab vs placebo consolidation therapy after chemoradiotherapy in stage III non-small-cell lung cancer: An updated PACIFIC trial-based cost-effectiveness analysis.,"INTRODUCTION


Recently updated three-year survival data from the PACIFIC trial showed that durvalumab consolidation therapy improved OS rates versus placebo for patients with unresectable stage III non-small cell lung cancer (NSCLC) after chemoradiotherapy. Considering the impact of the high cost of durvalumab, its cost-effectiveness should be updated to see if its cost-effectiveness has changed from the US payers' perspective.
METHODS


A comprehensive Markov model was used to evaluate mean lifetime costs and effectiveness of first-line durvalumab consolidation therapy versus placebo for patients with unresectable stage III NSCLC imputing updated survival and quality-of-life data from the PACIFIC trial. The main endpoints include total costs, life years (LYs), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). One-way, two-way, and probabilistic sensitivity analyses were conducted to access the uncertainty in the variables. We also considered durvalumab cost-effectiveness in the subgroups.
RESULTS


Durvalumab consolidation therapy resulted in additional 1.34 LYs and 1.01 QALYs, resulting in an ICER of $138,920 per QALY versus the placebo treatment. One-way sensitivity analysis revealed that the utility values of two treatments, body weight, and unit cost of durvalumab have the greatest influence on the result. Subgroup analyses demonstrated that durvalumab was more cost effective for patients with non-squamous-cell lung cancer, followed by 25% or greater PD-L1 expression. Probabilistic sensitivity analysis showed that the probability of durvalumab being cost-effective versus the placebo is 62.6% at a willingness-to-pay (WTP) of $150,000 per QALY CONCLUSION: Our analyses demonstrated that receiving durvalumab consolidation therapy was more cost-effective than placebo at a WTP threshold of $150,000. These results can be of use to US practitioners in the application of durvalumab and for durvalumab prescription and reimbursement policies.",2020,"Subgroup analyses demonstrated that durvalumab was more cost effective for patients with non-squamous-cell lung cancer, followed by 25% or greater PD-L1 expression.","['patients with unresectable stage III non-small cell lung cancer (NSCLC) after chemoradiotherapy', 'patients with unresectable stage III NSCLC imputing updated survival and quality-of-life data from the PACIFIC trial', 'stage III non-small-cell lung cancer']","['durvalumab consolidation therapy', 'durvalumab', 'Durvalumab vs placebo consolidation therapy after chemoradiotherapy', 'placebo']","['total costs, life years (LYs), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs', 'mean lifetime costs and effectiveness', 'OS rates', 'cost effective']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278506', 'cui_str': 'Non-small cell lung cancer stage III'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0947434,"Subgroup analyses demonstrated that durvalumab was more cost effective for patients with non-squamous-cell lung cancer, followed by 25% or greater PD-L1 expression.","[{'ForeName': 'Jiaqi', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Department of Head and Neck Oncology and Department of Radiation Oncology, Cancer Center and State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu 610041, PR China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Tian', 'Affiliation': 'Department of Urology, Institute of Urology, West China Hospital, Sichuan University, Chengdu 610041, PR China.'}, {'ForeName': 'Jiangping', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Head and Neck Oncology and Department of Radiation Oncology, Cancer Center and State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu 610041, PR China.'}, {'ForeName': 'Youling', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'Department of Thoracic Oncology and State Key Laboratory of Biotherapy, Cancer Center, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, PR China. Electronic address: gongyouling@hotmail.com.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.05.011']
2050,32512291,"Rationale and design of the PRAETORIAN-COVID trial: A double-blind, placebo-controlled randomized clinical trial with valsartan for PRevention of Acute rEspiraTORy dIstress syndrome in hospitAlized patieNts with SARS-COV-2 Infection Disease.","There is much debate on the use of angiotensin receptor blockers (ARBs) in severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2)-infected patients. Although it has been suggested that ARBs might lead to a higher susceptibility and severity of SARS-CoV-2 infection, experimental data suggest that ARBs may reduce acute lung injury via blocking angiotensin-II-mediated pulmonary permeability, inflammation, and fibrosis. However, despite these hypotheses, specific studies on ARBs in SARS-CoV-2 patients are lacking. METHODS: The PRAETORIAN-COVID trial is a multicenter, double-blind, placebo-controlled 1:1 randomized clinical trial in adult hospitalized SARS-CoV-2-infected patients (n = 651). The primary aim is to investigate the effect of the ARB valsartan compared to placebo on the composite end point of admission to an intensive care unit, mechanical ventilation, or death within 14 days of randomization. The active-treatment arm will receive valsartan in a dosage titrated to blood pressure up to a maximum of 160 mg bid, and the placebo arm will receive matching placebo. Treatment duration will be 14 days, or until the occurrence of the primary end point or until hospital discharge, if either of these occurs within 14 days. The trial is registered at clinicaltrials.gov (NCT04335786, 2020). SUMMARY: The PRAETORIAN-COVID trial is a double-blind, placebo-controlled 1:1 randomized trial to assess the effect of valsartan compared to placebo on the occurrence of ICU admission, mechanical ventilation, and death in hospitalized SARS-CoV-2-infected patients. The results of this study might impact the treatment of SARS-CoV-2 patients globally.",2020,There is much debate on the use of angiotensin receptor blockers (ARBs) in severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2)-infected patients.,"['hospitalized SARS-CoV-2-infected patients', 'hospitAlized patieNts with SARS-COV-2 Infection Disease', 'severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2)-infected patients', 'adult hospitalized SARS-CoV-2-infected patients (n = 651']","['valsartan', 'ARB valsartan', 'angiotensin receptor blockers (ARBs', 'placebo arm will receive matching placebo', 'placebo']","['occurrence of ICU admission, mechanical ventilation, and death']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.592181,There is much debate on the use of angiotensin receptor blockers (ARBs) in severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2)-infected patients.,"[{'ForeName': 'D H Frank', 'Initials': 'DHF', 'LastName': 'Gommans', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands. Electronic address: frank.gommans@radboudumc.nl.'}, {'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'Nas', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Sara-Joan', 'Initials': 'SJ', 'LastName': 'Pinto-Sietsma', 'Affiliation': 'Department of Vascular Medicine, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Koop', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Regina E', 'Initials': 'RE', 'LastName': 'Konst', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Mensink', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Goaris W A', 'Initials': 'GWA', 'LastName': 'Aarts', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Lara S F', 'Initials': 'LSF', 'LastName': 'Konijnenberg', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Cortenbach', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Dominique V M', 'Initials': 'DVM', 'LastName': 'Verhaert', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands; Department of Cardiology, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center (MUMC+), Maastricht, the Netherlands.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Thannhauser', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Jan-Quinten', 'Initials': 'JQ', 'LastName': 'Mol', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Maxim J P', 'Initials': 'MJP', 'LastName': 'Rooijakkers', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Jacqueline L', 'Initials': 'JL', 'LastName': 'Vos', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Anouke', 'Initials': 'A', 'LastName': 'van Rumund', 'Affiliation': 'Department of Neurology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Vart', 'Affiliation': 'Department of Biostatistics, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Robert-Jan', 'Initials': 'RJ', 'LastName': 'Hassing', 'Affiliation': 'Department of Internal Medicine, Rijnstate Hospital, Arnhem, the Netherlands.'}, {'ForeName': 'Jan-Hein', 'Initials': 'JH', 'LastName': 'Cornel', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands; Department of Cardiology, Noordwest Ziekenhuisgroep, Alkmaar, the Netherlands.'}, {'ForeName': 'C Peter C', 'Initials': 'CPC', 'LastName': 'de Jager', 'Affiliation': ""Department of Intensive Care, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands.""}, {'ForeName': 'Michel M', 'Initials': 'MM', 'LastName': 'van den Heuvel', 'Affiliation': 'Department of Pulmonary diseases, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Hans G', 'Initials': 'HG', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Intensive Care, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Verbon', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, ErasmusMC, Rotterdam, the Netherlands.'}, {'ForeName': 'Yigal M', 'Initials': 'YM', 'LastName': 'Pinto', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Roland R J', 'Initials': 'RRJ', 'LastName': 'van Kimmenade', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'de Leeuw', 'Affiliation': 'Department of Internal Medicine, Maastricht UMC, Maastricht, the Netherlands.'}, {'ForeName': 'Michiel A', 'Initials': 'MA', 'LastName': 'van Agtmael', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bresser', 'Affiliation': 'Department of Pulmonary Diseases, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Wiek H', 'Initials': 'WH', 'LastName': 'van Gilst', 'Affiliation': 'Department of Experimental Cardiology, UMCG, Groningen, the Netherlands.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Vonk-Noordergraaf', 'Affiliation': 'Department of Pulmonary Diseases, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Jan G P', 'Initials': 'JGP', 'LastName': 'Tijssen', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'C Peter C', 'Initials': 'CPC', 'LastName': 'de Jager', 'Affiliation': ""Department of Intensive Care, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands.""}, {'ForeName': 'Michel M', 'Initials': 'MM', 'LastName': 'van den Heuvel', 'Affiliation': 'Department of Pulmonary diseases, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Hans G', 'Initials': 'HG', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Intensive Care, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Verbon', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, ErasmusMC, Rotterdam, the Netherlands.'}, {'ForeName': 'Yigal M', 'Initials': 'YM', 'LastName': 'Pinto', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Roland R J', 'Initials': 'RRJ', 'LastName': 'van Kimmenade', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}]",American heart journal,['10.1016/j.ahj.2020.05.010']
2051,32512314,Women's unmet needs in early labour: Qualitative analysis of free-text survey responses in the M@NGO trial of caseload midwifery.,"OBJECTIVE


to analyse women's experiences of early labour care in caseload midwifery in Australia.
DESIGN


this study sits within a multi-site randomised controlled trial of caseload midwifery versus standard care. Participant surveys were conducted at 6-weeks and 6-months after birth. Free-text responses about experiences of care were subject to critical thematic analysis in NVivo 11 software.
SETTING


two urban Australian hospitals in different states.
PARTICIPANTS


women 18 years and over, with a singleton pregnancy, less than 24 weeks' pregnant, not planning a caesarean section or already booked with a care provider; were eligible to participate in the trial.
INTERVENTIONS


participants were randomised to caseload midwifery or standard care for antenatal, labour and birth and postpartum care.
MEASUREMENTS AND FINDINGS


The 6-week survey response rate was 58% (n = 1,019). The survey included five open questions about women's experiences of pregnancy, labour and birth, and postnatal care. Nine-hundred and one respondents (88%) provided free text comments which were coded to generate 10 categories. The category of early labour contained data from 84 individual participants (caseload care n = 44; standard care n = 40). Descriptive themes were: (1) needing permission; (2) doing the 'wrong' thing; and (3) being dismissed. Analytic themes were: (1) Seeking: women wanting to be ""close to those who know what's going on""; and (2) Shielding: midwives defending resources and normal birth.
KEY CONCLUSIONS


Regardless of model of care, early labour care was primarily described in negative terms. This could be attributed to reporting bias, because women who were neutral about early labour care may not comment. Nevertheless, the findings demonstrate a gap in knowledge about early labour care in caseload midwifery models.
IMPLICATIONS FOR PRACTICE


Maternity services that offer caseload midwifery are ideally placed to evaluate how early labour home visiting impacts women's experiences of early labour.",2020,"IMPLICATIONS FOR PRACTICE


Maternity services that offer caseload midwifery are ideally placed to evaluate how early labour home visiting impacts women's experiences of early labour.","['two urban Australian hospitals in different states', 'Nine-hundred and one respondents (88%) provided free text comments which were coded to generate 10 categories', '84 individual participants (caseload care n\xa0=\xa044; standard care n\xa0=\xa040', ""Women's unmet needs in early labour"", ""women's experiences of early labour care in caseload midwifery in Australia"", ""women 18 years and over, with a singleton pregnancy, less than 24 weeks' pregnant, not planning a caesarean section or already booked with a care provider; were eligible to participate in the trial""]","['caseload midwifery versus standard care', 'caseload midwifery or standard care for antenatal, labour and birth and postpartum care']","['pregnancy, labour and birth, and postnatal care']","[{'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0282411', 'cui_str': 'Editorial Comment'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1171200', 'cui_str': 'Labor care'}, {'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}]","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}]",,0.0808094,"IMPLICATIONS FOR PRACTICE


Maternity services that offer caseload midwifery are ideally placed to evaluate how early labour home visiting impacts women's experiences of early labour.","[{'ForeName': 'Jyai', 'Initials': 'J', 'LastName': 'Allen', 'Affiliation': 'Mater Research Institute-The University of Queensland, Brisbane, Queensland, Australia; School of Nursing and Midwifery, Griffith University, Meadowbrook, Queensland, Australia. Electronic address: jyai.allen@griffith.edu.au.'}, {'ForeName': 'Bec', 'Initials': 'B', 'LastName': 'Jenkinson', 'Affiliation': 'Mater Research Institute-The University of Queensland, Brisbane, Queensland, Australia. Electronic address: bec.jenkinson@mater.uq.edu.au.'}, {'ForeName': 'Sally K', 'Initials': 'SK', 'LastName': 'Tracy', 'Affiliation': ""Midwifery and Women's Health Research Unit, University of Sydney, Royal Hospital for Women, Randwick, New South Wales, Australia. Electronic address: sally.tracy@sydney.edu.au.""}, {'ForeName': 'Donna L', 'Initials': 'DL', 'LastName': 'Hartz', 'Affiliation': ""Midwifery and Women's Health Research Unit, University of Sydney, Royal Hospital for Women, Randwick, New South Wales, Australia; College of Nursing and Midwifery, Charles Darwin University, Sydney Campus, New South Wales, Australia. Electronic address: donna.hartz@cdu.edu.au.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tracy', 'Affiliation': ""Department of Paediatrics and Child health Westmead Children's Clinical School, The University of Sydney, Westmead, New South Wales, Australia; Westmead Neonatal Intensive Care Unit, Westmead Hospital, Western Sydney Local Health District, New South Wales, Australia. Electronic address: mark.tracy@sydney.edu.au.""}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Kildea', 'Affiliation': 'Mater Research Institute-The University of Queensland, Brisbane, Queensland, Australia; Molly Wardaguga Research Centre, College of Nursing and Midwifery, Charles Darwin University, Queensland, Australia. Electronic address: sue.kildea@cdu.edu.au.'}]",Midwifery,['10.1016/j.midw.2020.102751']
2052,32512353,A Randomized Controlled Trial of Transcultural Validation of Group-Based Psychosocial Intervention for Patients with Bipolar Disorder.,"Adjunctive psychosocial interventions are part of the preferred method to treat bipolar disorder (BD). This study aimed to conduct a randomized control and protocol-guided trial, in order to evaluate the feasibility and effectiveness of adjunctive group-based treatments for Chinese outpatients with BD. A single-blind trial in which 68 outpatients with BD were randomly assigned to either treatment as usual (TAU) or to an experimental group with 12 additional weekly sessions and 3 monthly booster sessions. Participants were assessed at baseline for mood condition, suicidal ideation, medication adherence, and quality of life (QoL), with follow-up assessments every 3 months over a 1-year period. The overall retention rate of this study was 89.7%. The results showed significant differences between groups for the variables evaluated, which included achieving euthymia, decrease of depression symptoms, and improvement of QoL. No improvements in medication adherence, reduction in manic symptoms, or suicidal ideation was observed. The results of this study support the transcultural validity and efficacy of group-based psychosocial intervention as anadjunct to TAU among Chinese outpatients with BD to promote improvements during the course of the illness including achieving euthymia, reducing depressive symptoms, and improving QoL.",2020,"The results showed significant differences between groups for the variables evaluated, which included achieving euthymia, decrease of depression symptoms, and improvement of QoL. No improvements in medication adherence, reduction in manic symptoms, or suicidal ideation was observed.","['68 outpatients with BD', 'Patients with Bipolar Disorder', 'Chinese outpatients with BD']","['Adjunctive psychosocial interventions', 'psychosocial intervention', 'Group-Based Psychosocial Intervention']","['mood condition, suicidal ideation, medication adherence, and quality of life (QoL', 'medication adherence, reduction in manic symptoms, or suicidal ideation', 'feasibility and effectiveness', 'depression symptoms', 'transcultural validity and efficacy', 'depressive symptoms, and improving QoL', 'overall retention rate']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0338831', 'cui_str': 'Mania'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",68.0,0.0479467,"The results showed significant differences between groups for the variables evaluated, which included achieving euthymia, decrease of depression symptoms, and improvement of QoL. No improvements in medication adherence, reduction in manic symptoms, or suicidal ideation was observed.","[{'ForeName': 'Chen-Ju', 'Initials': 'CJ', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan; Institute of Health and Welfare Policy, National Yang-Ming University.'}, {'ForeName': 'Yu-Hsin', 'Initials': 'YH', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan; Department of Medicine, MacKay Medical College, Taipei, Taiwan.'}, {'ForeName': 'Kuo-Yang', 'Initials': 'KY', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, Taiwan Adventist Hospital, Taipei, Taiwan.'}, {'ForeName': 'Shu-I', 'Initials': 'SI', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan; Department of Audiology and Speech Language Pathology, MacKay Medical College, Taipei, Taiwan.'}, {'ForeName': 'Yi-Hung', 'Initials': 'YH', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Hsiao-Mei', 'Initials': 'HM', 'LastName': 'Yeh', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chih-Hung', 'Initials': 'CH', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan; Department of Medicine, MacKay Medical College, Taipei, Taiwan.'}, {'ForeName': 'I-Chieh', 'Initials': 'IC', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Hui-Chun', 'Initials': 'HC', 'LastName': 'Huang', 'Affiliation': 'Department of Medical Research, MacKay Memorial Hospital, Taipei, Taiwan; MacKay Junior College of Medicine, Nursing and Management, Taipei, Taiwan.'}, {'ForeName': 'Fang-Ju', 'Initials': 'FJ', 'LastName': 'Sun', 'Affiliation': 'Department of Medical Research, MacKay Memorial Hospital, Taipei, Taiwan; MacKay Junior College of Medicine, Nursing and Management, Taipei, Taiwan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Berk', 'Affiliation': 'School of Medicine, Deakin University, Victoria, Australia.'}, {'ForeName': 'Shen-Ing', 'Initials': 'SI', 'LastName': 'Liu', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan; Department of Medicine, MacKay Medical College, Taipei, Taiwan; Department of Medical Research, MacKay Memorial Hospital, Taipei, Taiwan. Electronic address: maryliuyip@gmail.com.'}]",Psychiatry research,['10.1016/j.psychres.2020.113139']
2053,32513881,"Evaluation of the For Our Children's Sake intervention, parental support in prison to influence positive parenting: study protocol for a controlled trial.","INTRODUCTION


Children of incarcerated parents comprise a greatly disadvantaged group in society and positive parenting constitutes an important factor for children's healthy development. Internationally developed parenting interventions for incarcerated parents suggest an impact on parenting outcomes, but no such evaluation has been undertaken in Sweden.This study aims to investigate the effects of the parenting programme currently offered in prisons in Sweden, For Our Children's Sake (FOCS), through a controlled trial with a parallel implementation process evaluation.
METHODS AND ANALYSIS


The effectiveness trial is carried out as a non-blinded controlled trial with a parallel investigation of the implementation process using mixed methods. Participants comprise incarcerated parents (men and women) in Swedish prisons with a target sample size of 76 parents. Eligible parents have a child aged 0 to 18 years, no prohibition to contact or committed a crime against the child, or a violent crime against the other parent. The FOCS intervention is carried out in group format over 10 weeks. The primary outcome is closeness in parent-child relationship measured with the Child Parent Relationship Scale. Secondary outcomes comprise parent-child contact, parental criminal attitude and interest in other treatment programmes. Mediators comprise attitude to parenting, and self-efficacy. Outcome data are self-reported and collected over four time points: baseline (September to December 2019), mid and after intervention, and at 3 months follow-up. Implementation data is collected during and after intervention. Intervention fidelity is monitored through audio recordings, dose is registered per participant, reach comprise included versus eligible number of parents and acceptability is investigated through semi-structured interviews. Factors influencing implementation will be investigated using a questionnaire.
ETHICS AND DISSEMINATION


Ethical permission has been obtained by the Swedish Ethical Review Authority 2019-04227. Findings will be published in peer-reviewed journals, presented at scientific conferences and presented to participants in writing.
TRIAL REGISTRATION NUMBER


NCT04101799; Pre-results.",2020,"Internationally developed parenting interventions for incarcerated parents suggest an impact on parenting outcomes, but no such evaluation has been undertaken in Sweden.","[""prisons in Sweden, For Our Children's Sake (FOCS"", 'Participants comprise incarcerated parents (men and women) in Swedish prisons with a target sample size of 76 parents', 'Eligible parents have a child aged 0 to 18 years, no prohibition to contact or committed a crime against the child, or a violent crime against the other parent', ""children's healthy development""]","['FOCS intervention', 'parenting programme']","['parent-child contact, parental criminal attitude and interest in other treatment programmes', 'closeness in parent-child relationship measured with the Child Parent Relationship Scale']","[{'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0392751', 'cui_str': 'In prison'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0010325', 'cui_str': 'Crime'}, {'cui': 'C0242151', 'cui_str': 'Violent'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0699726', 'cui_str': 'Offenders'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.235758,"Internationally developed parenting interventions for incarcerated parents suggest an impact on parenting outcomes, but no such evaluation has been undertaken in Sweden.","[{'ForeName': 'Asa', 'Initials': 'A', 'LastName': 'Norman', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Stockholm County, Sweden asa.norman@ki.se.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Enebrink', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Stockholm County, Sweden.'}]",BMJ open,['10.1136/bmjopen-2019-034834']
2054,32513895,Does delaying discharge from intensive care until after tracheostomy removal affect 30-day mortality? Propensity score matched cohort study.,"OBJECTIVE


To investigate the short-term mortality effect of discharge from an intensive care unit (ICU) with a tracheostomy in place in comparison to delaying discharge until after tracheostomy removal.
DESIGN


A propensity score matched cohort study using data from the TracMan study.
SETTING


Seventy-two UK ICUs taking part in the TracMan study, a randomised controlled trial comparing early tracheostomy (within 4 days of critical care admission) with deferred tracheostomy (after 10 days if still indicated).
PARTICIPANTS


622 patients who underwent a tracheostomy while in the TracMan study between November 2004 and November 2008. 144 patients left ICU with a tracheostomy. 999 days of observation from 294 patients were included in the control pool.
INTERVENTIONS


We matched patients discharged with a tracheostomy in place 1:1 with patients who remained in an ICU until either their tracheostomy was removed or they died with the tracheostomy in place. Propensity models were developed according to discharge destination, accounting for likely confounding factors.
PRIMARY OUTCOME MEASURE


The primary outcome was 30-day mortality from the matching day. For the 'discharged with a tracheostomy' group, this was death within 30 days after the discharge day. For the 'remained in ICU' group, this was death within 30 days after the matched day.
RESULTS


22 (15.3%) patients who left ICU with a tracheostomy died within 30 days compared with 26 (18.1%) who remained in ICU (relative risk 0.98, 95% CI 0.43 to 2.23).
CONCLUSION


Keeping patients on an ICU to provide tracheostomy care was not found to affect mortality. Tracheostomy presence may indicate a higher risk of mortality due to underlying diseases and conditions rather than posing a risk in itself.The TracMan trial was registered on the ISRCTN database (ISRCTN28588190).",2020,"RESULTS


22 (15.3%) patients who left ICU with a tracheostomy died within 30 days compared with 26 (18.1%) who remained in ICU (relative risk 0.98, 95% CI 0.43 to 2.23).
","['Seventy-two UK ICUs taking part in the TracMan study, a randomised controlled trial comparing early tracheostomy (within 4 days of critical care admission) with deferred tracheostomy (after 10 days if still indicated', 'matched patients discharged with a tracheostomy in place 1:1 with patients who remained in an ICU until either their tracheostomy was removed or they died with the tracheostomy in place', '294 patients were included in the control pool', '622 patients who underwent a tracheostomy while in the TracMan study between November 2004 and November 2008', '144 patients left ICU with a tracheostomy']",['intensive care unit (ICU'],['30-day mortality'],"[{'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0205091', 'cui_str': 'Left'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",294.0,0.23793,"RESULTS


22 (15.3%) patients who left ICU with a tracheostomy died within 30 days compared with 26 (18.1%) who remained in ICU (relative risk 0.98, 95% CI 0.43 to 2.23).
","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Vollam', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, Oxford University, Oxford, Oxon, UK sarah.vollam@ndcn.ox.ac.uk.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Harrison', 'Affiliation': 'Intensive Care National Audit and Research Centre, London, UK.'}, {'ForeName': 'J Duncan', 'Initials': 'JD', 'LastName': 'Young', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, Oxford University, Oxford, Oxon, UK.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Watkinson', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, Oxford University, Oxford, Oxon, UK.'}]",BMJ open,['10.1136/bmjopen-2020-037762']
2055,32513936,Investigating resting brain perfusion abnormalities and disease target-engagement by intranasal oxytocin in women with bulimia nervosa and binge-eating disorder and healthy controls.,"Advances in the treatment of bulimia nervosa and binge-eating disorder (BN/BED) have been marred by our limited understanding of the underpinning neurobiology. Here we measured regional cerebral blood flow (rCBF) to map resting perfusion abnormalities in women with BN/BED compared with healthy controls and investigate whether intranasal oxytocin (OT), proposed as a potential treatment, can restore perfusion in disorder-related brain circuits. Twenty-four women with BN/BED and 23 healthy women participated in a randomized, double-blind, crossover, placebo-controlled study. We used arterial spin labelling MRI to measure rCBF and the effects of an acute dose of intranasal OT (40 IU) or placebo over 18-26 min post dosing, as we have previously shown robust OT-induced changes in resting rCBF in men in a similar time-window (15-36 min post dosing). We tested for effects of treatment, diagnosis and their interaction on extracted rCBF values in anatomical regions-of-interest previously implicated in BN/BED by other neuroimaging modalities, and conducted exploratory whole-brain analyses to investigate previously unidentified brain regions. We demonstrated that women with BN/BED presented increased resting rCBF in the medial prefrontal and orbitofrontal cortices, anterior cingulate gyrus, posterior insula and middle/inferior temporal gyri bilaterally. Hyperperfusion in these areas specifically correlated with eating symptoms severity in patients. Our data did not support a normalizing effect of intranasal OT on perfusion abnormalities in these patients, at least for the specific dose (40 IU) and post-dosing interval (18-26 min) examined. Our findings enhance our understanding of resting brain abnormalities in BN/BED and identify resting rCBF as a non-invasive potential biomarker for disease-related changes and treatment monitoring. They also highlight the need for a comprehensive investigation of intranasal OT pharmacodynamics in women before we can fully ascertain its therapeutic value in disorders affecting predominantly this gender, such as BN/BED.",2020,"We demonstrated that women with BN/BED presented increased resting rCBF in the medial prefrontal and orbitofrontal cortices, anterior cingulate gyrus, posterior insula and middle/inferior temporal gyri bilaterally.","['Twenty-four women with BN/BED and 23 healthy women', 'women with BN/BED compared with healthy controls', 'bulimia nervosa and binge-eating disorder (BN/BED', 'women with bulimia nervosa and binge-eating disorder and healthy controls']","['intranasal OT', 'intranasal oxytocin (OT', 'intranasal oxytocin', 'placebo']","['perfusion abnormalities', 'medial prefrontal and orbitofrontal cortices, anterior cingulate gyrus, posterior insula and middle/inferior temporal gyri bilaterally', 'resting rCBF', 'regional cerebral blood flow (rCBF', 'eating symptoms severity']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2267227', 'cui_str': 'Bulimia nervosa'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0152301', 'cui_str': 'Structure of orbital gyrus'}, {'cui': 'C0018427', 'cui_str': 'Structure of cingulate gyrus'}, {'cui': 'C0228261', 'cui_str': 'Structure of long insular gyrus'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}]",24.0,0.231848,"We demonstrated that women with BN/BED presented increased resting rCBF in the medial prefrontal and orbitofrontal cortices, anterior cingulate gyrus, posterior insula and middle/inferior temporal gyri bilaterally.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Martins', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Leslie', 'Affiliation': ""Section of Eating Disorders, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Rodan', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Zelaya', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Treasure', 'Affiliation': ""Section of Eating Disorders, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Paloyelis', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK. yannis.paloyelis@kcl.ac.uk.""}]",Translational psychiatry,['10.1038/s41398-020-00871-w']
2056,32514040,A registered replication study on oxytocin and trust.,"In an influential paper, Kosfeld et al. (2005) showed that intranasal administration of oxytocin (OT) increases the transfers made by investors in the trust game-suggesting that OT increases trust in strangers. Subsequent studies investigating the role of OT in the trust game found inconclusive effects on the trusting behaviour of investors but these studies deviated from the Kosfeld et al. study in an important way-they did not implement minimal social contact (MSC) between the investors and the trustees in the trust game. Here, we performed a large double-blind and placebo-controlled replication study of the effects of OT on trusting behaviour that yields a power of more than 95% and implements an MSC condition as well as a no-social-contact (NoC) condition. We find no effect of OT on trusting behaviour in the MSC condition. Exploratory post hoc analyses suggest that OT may increase trust in individuals with a low disposition to trust in the NoC condition, but this finding requires confirmation in future research. PROTOCOL REGISTRATION: The stage 1 protocol for this Registered Report was accepted in principle on 19 October 2018. The protocol, as accepted by the journal, can be found at https://doi.org/10.6084/m9.figshare.11980368.",2020,"Exploratory post hoc analyses suggest that OT may increase trust in individuals with a low disposition to trust in the NoC condition, but this finding requires confirmation in future research.",[],"['OT', 'oxytocin', 'oxytocin (OT', 'placebo']",[],[],"[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0573493,"Exploratory post hoc analyses suggest that OT may increase trust in individuals with a low disposition to trust in the NoC condition, but this finding requires confirmation in future research.","[{'ForeName': 'Carolyn H', 'Initials': 'CH', 'LastName': 'Declerck', 'Affiliation': 'Faculty of Business and Economics, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Boone', 'Affiliation': 'Faculty of Business and Economics, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Loren', 'Initials': 'L', 'LastName': 'Pauwels', 'Affiliation': 'Faculty of Business and Economics, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Bodo', 'Initials': 'B', 'LastName': 'Vogt', 'Affiliation': 'Chair in Empirical Economics and Health Economics, Otto-von-Guericke-University Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Ernst', 'Initials': 'E', 'LastName': 'Fehr', 'Affiliation': 'Laboratory for Social and Neural Systems Research, Department of Economics, University of Zurich, Zurich, Switzerland. ernst.fehr@econ.uzh.ch.'}]",Nature human behaviour,['10.1038/s41562-020-0878-x']
2057,32530908,Durable Efficacy of Dolutegravir Plus Lamivudine in Antiretroviral Treatment-Naive Adults With HIV-1 Infection: 96-Week Results From the GEMINI-1 and GEMINI-2 Randomized Clinical Trials: Erratum.,,2020,,['Antiretroviral Treatment-Naive Adults With HIV-1 Infection'],['Dolutegravir Plus Lamivudine'],['Durable Efficacy'],"[{'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2363741', 'cui_str': 'HIV-1 infection'}]","[{'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.146493,,[],Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002394']
2058,32531253,The stability of children's salivary peptidome profiles in response to short-term beverage consumption.,"BACKGROUND


Salivary peptidome profiling analysis has advantages of simplicity and non-invasiveness and great potentiality for screening, monitoring or primary diagnosis of diseases, but may be subjected to change against interferences like diet.
METHODS


We conducted a 5-day study to investigate the influence of 3 kinds of beverages (orange juice, sugar-free tea, and sugar-free liquid yoghurt; water as control) on children's salivary peptidome using mass spectrometry techniques.
RESULTS


All the groups shared a relatively stable pattern in heatmaps during the experimental days. Principal component analysis plot presented slight shifts in all the intervention groups between the baseline and intervention period while samples were not distinctly separated by date. The numbers of significantly changed peptides after short-term orange juice and tea intervention were four and three, respectively, while no changes occurred in the yoghurt group and control. Four of these peptides were identified as histatin-3, collagen alpha-1(IV) chain, zinc finger protein 805, and quinolinate synthase A.
CONCLUSIONS


Salivary peptidome has its own stability against beverage intervention, confirming the feasibility and validity of using it as a potential reference for the healthy state of the body, with diet habits recorded and considered as a confounder if necessary.",2020,"Four of these peptides were identified as histatin-3, collagen alpha-1(IV) chain, zinc finger protein 805, and quinolinate synthase A.
CONCLUSIONS


","[""children's salivary peptidome using mass spectrometry techniques""]","['beverages (orange juice, sugar-free tea, and sugar-free liquid yoghurt; water as control']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0037813', 'cui_str': 'Mass spectrometry measurement'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.020256,"Four of these peptides were identified as histatin-3, collagen alpha-1(IV) chain, zinc finger protein 805, and quinolinate synthase A.
CONCLUSIONS


","[{'ForeName': 'Fangqiao', 'Initials': 'F', 'LastName': 'Wei', 'Affiliation': 'Department of Preventive Dentistry, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China.'}, {'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Preventive Dentistry, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China.'}, {'ForeName': 'Peiyuan', 'Initials': 'P', 'LastName': 'Tong', 'Affiliation': 'Department of Preventive Dentistry, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China.'}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Preventive Dentistry, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China.'}, {'ForeName': 'Ce', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Preventive Dentistry, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'Central Laboratory, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China.'}, {'ForeName': 'Shuguo', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'Department of Preventive Dentistry, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China. Electronic address: kqzsg86@bjmu.edu.cn.'}]",Clinica chimica acta; international journal of clinical chemistry,['10.1016/j.cca.2020.06.018']
2059,32531956,Effect of a Six-Week Intermittent Fasting Intervention Program on the Composition of the Human Body in Women over 60 Years of Age.,"The objective of this research was to determine the effectiveness of intermittent fasting (IF) in reducing body fat and lowering body mass index. An additional objective was to determine the feasibility of applying IF in overweight women over 60 years of age, which was assessed by the ratio of subjects who resigned from the diet plan. This study included a group of 45 women over 60 years of age. The intervention in the experimental group involved complete abstinence from food intake for 16 h per day, from 20:00 p.m. to 12:00 a.m. (the next day). The results demonstrated that the body weight in the subjects in the experimental group (EXP) group decreased by almost 2 kg and this decrease was visible in the remaining parameters related to body fat mass. The skeletal muscle mass did not change significantly, which indicates an actual decrease in the fat mass. The proportion of subjects who did not succeed in following the prescribed diet plan was 12%. The application of intermittent fasting in female subjects over 60 years of age resulted in positive changes in body composition. Time-restricted feeding (TRF) was characterized by a lower resignation rate compared to other diets involving intermittent fasting.",2020,Time-restricted feeding (TRF) was characterized by a lower resignation rate compared to other diets involving intermittent fasting.,"['Women over 60 Years of Age', 'female subjects over 60 years of age resulted in positive changes in body composition', 'overweight women over 60 years of age, which was assessed by the ratio of subjects who resigned from the diet plan', '45 women over 60 years of age']",['Six-Week Intermittent Fasting Intervention Program'],"['body weight', 'body fat and lowering body mass index', 'Time-restricted feeding (TRF', 'skeletal muscle mass']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4704881', 'cui_str': 'Intermittent Fasting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4704883', 'cui_str': 'Time Restricted Feeding'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",,0.0208379,Time-restricted feeding (TRF) was characterized by a lower resignation rate compared to other diets involving intermittent fasting.,"[{'ForeName': 'Przemysław', 'Initials': 'P', 'LastName': 'Domaszewski', 'Affiliation': 'Faculty of Physical Education and Physiotherapy, Opole University of Technology, 45-758 Opole, Poland.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Konieczny', 'Affiliation': 'Faculty of Physical Education and Physiotherapy, Opole University of Technology, 45-758 Opole, Poland.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Pakosz', 'Affiliation': 'Faculty of Physical Education and Physiotherapy, Opole University of Technology, 45-758 Opole, Poland.'}, {'ForeName': 'Dawid', 'Initials': 'D', 'LastName': 'Bączkowicz', 'Affiliation': 'Faculty of Physical Education and Physiotherapy, Opole University of Technology, 45-758 Opole, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Sadowska-Krępa', 'Affiliation': 'Institute of Sport Sciences, the Jerzy Kukuczka Academy of Physical Education, 40-065 Katowice, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17114138']
2060,32532068,Beneficial Molecular Adaptations In  BRCA -Mutation Carriers By Combined HIT/HIRT Intervention: Results From A Pilot Study.,":  Based on growing evidence that breast cancer (BRCA) also plays a pivotal role in the regulation of skeletal muscle metabolism and the response to anti-oxidative stress, we examined the influence of regular exercise in human  BRCA  mutation carriers on their BRCA1 gene/protein expression and inflammatory/oxidative response. Sixteen  BRCA -mutation carriers were assigned to an intervention (IG) or control group (CG). IG received a combination of high-intensity interval endurance (HIT) and strength training (HIRT) for six weeks, whereas CG received a low-intensity activity program. Before (T0) and at the end of the intervention (T1), muscle biopsy, physiological performance, blood withdrawal and anthropometry were obtained. Parameters included: Muscle BRCA1 gene/protein expression, inflammatory/oxidative stress, anti-oxidative capacity, peak oxygen capacity (VO 2 peak) and 1-repetition maximum (1-RM) at six different training machines. VO 2 peak and 1-RM of IG were increased at T1 compared to T0, whereas CG performance, physiological and molecular parameters remained unchanged. IG showed increased BRCA1 protein concentration as well as anti-oxidative capacity, whereas gene expression was unaltered. IG inflammatory and oxidative damage did not differ between time points. Combined HIT/HIRT increases aerobic and strength performance of  BRCA -mutation carriers with up regulated BRCA1 protein expression and improved anti-oxidative status without showing an increased inflammatory response.",2020,Combined HIT/HIRT increases aerobic and strength performance of  BRCA -mutation carriers with up regulated BRCA1 protein expression and improved anti-oxidative status without showing an increased inflammatory response.,['Sixteen  BRCA -mutation carriers'],"['combination of high-intensity interval endurance (HIT) and strength training (HIRT', 'HIT/HIRT Intervention', 'Combined HIT/HIRT']","['muscle biopsy, physiological performance, blood withdrawal and anthropometry', 'IG inflammatory and oxidative damage', 'aerobic and strength performance', 'VO 2 peak and 1-RM of IG', 'CG performance, physiological and molecular parameters', 'Muscle BRCA1 gene/protein expression, inflammatory/oxidative stress, anti-oxidative capacity, peak oxygen capacity (VO 2 peak) and 1-repetition maximum (1-RM', 'BRCA1 protein concentration', 'inflammatory response']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0185283', 'cui_str': 'Biopsy of muscle'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1528558', 'cui_str': 'BRCA1 protein, human'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0259275', 'cui_str': 'Breast cancer type 1 susceptibility protein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.037094,Combined HIT/HIRT increases aerobic and strength performance of  BRCA -mutation carriers with up regulated BRCA1 protein expression and improved anti-oxidative status without showing an increased inflammatory response.,"[{'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Bizjak', 'Affiliation': 'Ulm University Hospital, Division of Sports and Rehabilitation Medicine, 89075 Ulm, Germany.'}, {'ForeName': 'Sebastian V W', 'Initials': 'SVW', 'LastName': 'Schulz', 'Affiliation': 'Ulm University Hospital, Division of Sports and Rehabilitation Medicine, 89075 Ulm, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Schumann', 'Affiliation': 'Ulm University Hospital, Division of Sports and Rehabilitation Medicine, 89075 Ulm, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Otto', 'Affiliation': 'Ulm University Hospital, Division of Sports and Rehabilitation Medicine, 89075 Ulm, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Kirsten', 'Affiliation': 'Ulm University Hospital, Division of Sports and Rehabilitation Medicine, 89075 Ulm, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Ebner', 'Affiliation': 'Ulm University Hospital, Department of Gynecology and Obstetrics, 89075 Ulm, Germany.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Leinert', 'Affiliation': 'Ulm University Hospital, Department of Gynecology and Obstetrics, 89075 Ulm, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Huober', 'Affiliation': 'Ulm University Hospital, Department of Gynecology and Obstetrics, 89075 Ulm, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Janni', 'Affiliation': 'Ulm University Hospital, Department of Gynecology and Obstetrics, 89075 Ulm, Germany.'}, {'ForeName': 'Jürgen Michael', 'Initials': 'JM', 'LastName': 'Steinacker', 'Affiliation': 'Ulm University Hospital, Division of Sports and Rehabilitation Medicine, 89075 Ulm, Germany.'}]",Cancers,['10.3390/cancers12061526']
2061,32532097,"A Phase 1 Randomized Placebo-Controlled Study to Assess the Safety, Immunogenicity and Genetic Stability of a New Potential Pandemic H7N9 Live Attenuated Influenza Vaccine in Healthy Adults.","This study describes a double-blind randomized placebo-controlled phase I clinical trial in healthy adults of a new potential pandemic H7N9 live attenuated influenza vaccine (LAIV) based on the human influenza virus of Yangtze River Delta hemagglutinin lineage (ClinicalTrials.gov Identifier: NCT03739229). Two doses of H7N9 LAIV or placebo were administered intranasally to 30 and 10 subjects, respectively. The vaccine was well-tolerated and not associated with increased rates of adverse events or with any serious adverse events. Vaccine virus was detected in nasal swabs during the 6 days after vaccination or revaccination. A lower frequency of shedding was observed after the second vaccination. Twenty-five clinical viral isolates obtained after the first and second doses of vaccine retained the temperature-sensitive and cold-adapted phenotypic characteristics of LAIV. There was no confirmed transmission of the vaccine strain from vaccinees to placebo recipients. After the two H7N9 LAIV doses, an immune response was observed in 96.6% of subjects in at least one of the assays conducted.",2020,The vaccine was well-tolerated and not associated with increased rates of adverse events or with any serious adverse events.,"['healthy adults of a new potential pandemic H7N9 live attenuated', 'Healthy Adults']","['Placebo', 'New Potential Pandemic H7N9 Live Attenuated Influenza Vaccine', 'influenza vaccine (LAIV', 'H7N9 LAIV or placebo', 'placebo']","['frequency of shedding', 'Safety, Immunogenicity and Genetic Stability', 'immune response', 'rates of adverse events']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0016627', 'cui_str': 'Avian influenza'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0016627', 'cui_str': 'Avian influenza'}, {'cui': 'C3652556', 'cui_str': 'influenza, live attenuated'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.409709,The vaccine was well-tolerated and not associated with increased rates of adverse events or with any serious adverse events.,"[{'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Kiseleva', 'Affiliation': 'Federal State Budgetary Scientific Institution ""Institute of Experimental Medicine"", 197376 St Petersburg, Russia.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Isakova-Sivak', 'Affiliation': 'Federal State Budgetary Scientific Institution ""Institute of Experimental Medicine"", 197376 St Petersburg, Russia.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Stukova', 'Affiliation': 'Smorodintsev Research Institute of Influenza, Ministry of Health of the Russian Federation, 197376 St Petersburg, Russia.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Erofeeva', 'Affiliation': 'Smorodintsev Research Institute of Influenza, Ministry of Health of the Russian Federation, 197376 St Petersburg, Russia.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Donina', 'Affiliation': 'Federal State Budgetary Scientific Institution ""Institute of Experimental Medicine"", 197376 St Petersburg, Russia.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Larionova', 'Affiliation': 'Federal State Budgetary Scientific Institution ""Institute of Experimental Medicine"", 197376 St Petersburg, Russia.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Krutikova', 'Affiliation': 'Federal State Budgetary Scientific Institution ""Institute of Experimental Medicine"", 197376 St Petersburg, Russia.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Bazhenova', 'Affiliation': 'Federal State Budgetary Scientific Institution ""Institute of Experimental Medicine"", 197376 St Petersburg, Russia.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Stepanova', 'Affiliation': 'Federal State Budgetary Scientific Institution ""Institute of Experimental Medicine"", 197376 St Petersburg, Russia.'}, {'ForeName': 'Kirill', 'Initials': 'K', 'LastName': 'Vasilyev', 'Affiliation': 'Smorodintsev Research Institute of Influenza, Ministry of Health of the Russian Federation, 197376 St Petersburg, Russia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Matyushenko', 'Affiliation': 'Federal State Budgetary Scientific Institution ""Institute of Experimental Medicine"", 197376 St Petersburg, Russia.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Krylova', 'Affiliation': 'The Federal State Unitary Enterprise ""Scientific and Production Association for Immunological Preparations ""Microgen"", Ministry of Health of Russian Federation, 127473 Moscow, Russia.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Galatonova', 'Affiliation': 'The Federal State Unitary Enterprise ""Scientific and Production Association for Immunological Preparations ""Microgen"", Ministry of Health of Russian Federation, 127473 Moscow, Russia.'}, {'ForeName': 'Aleksey', 'Initials': 'A', 'LastName': 'Ershov', 'Affiliation': 'The Federal State Unitary Enterprise ""Scientific and Production Association for Immunological Preparations ""Microgen"", Ministry of Health of Russian Federation, 127473 Moscow, Russia.'}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Lioznov', 'Affiliation': 'Smorodintsev Research Institute of Influenza, Ministry of Health of the Russian Federation, 197376 St Petersburg, Russia.'}, {'ForeName': 'Erin Grace', 'Initials': 'EG', 'LastName': 'Sparrow', 'Affiliation': 'World Health Organization, 1211 Geneva, Switzerland.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Torelli', 'Affiliation': 'World Health Organization, 1211 Geneva, Switzerland.'}, {'ForeName': 'Larisa', 'Initials': 'L', 'LastName': 'Rudenko', 'Affiliation': 'Federal State Budgetary Scientific Institution ""Institute of Experimental Medicine"", 197376 St Petersburg, Russia.'}]",Vaccines,['10.3390/vaccines8020296']
2062,32532098,"Improvement in Healthy Meal Index, Lunch Quality, and Diversity Scores Following an Integrated Nutritional Intervention in a Communal Dining Room: The NEKST Study.","The objective of the NEKST (Nutrition Environmental Kibbutzim Study), a nonrandomized interventional study, was to evaluate the effect of an integrated intervention program on participants' lunch quality and diversity in two communal dining rooms (intervention  n  = 58 vs. control  n  = 54). The intervention included recipe modification, environmental changes, and an education program. The outcomes included simple healthy meal index (SHMI), lunch quality (LQS), and diversity scores (LDS) calculated based on photographs of lunch trays. A nutrition questionnaire assessed the changes in fruit and vegetable intake at baseline and 3 months following the intervention. The mean SHMI, LQS, and LDS increased in the intervention group (0.51,  p  < 0.001; 0.27,  p  = 0.045; 0.95,  p  < 0.001, respectively) but not in the control group ( p  = 0.865;  p  = 0.339;  p  = 0.354, respectively). Multivariable linear models demonstrate an increase in the SHMI (β = 0.26, 95% CI [0.12-0.76],  p  = 0.015), LQS (β = 0.23, 95% CI [0.06-0.83],  p  = 0.024), and LDS (β = 0.34, 95% CI [0.41-1.39],  p  < 0.001) of the participants in the intervention group. More participants in the intervention group raised their daily fruit intake compared with the control. We conclude that this integrated intervention program was effective in improving lunch healthy meal index, quality, and diversity in a communal dining room, with a modest halo effect of the intervention throughout the day.",2020,"The mean SHMI, LQS, and LDS increased in the intervention group (0.51,  p  < 0.001; 0.27,  p  = 0.045; 0.95,  p  < 0.001, respectively) but not in the control group (","[""participants' lunch quality and diversity in two communal dining rooms (intervention  n  = 58 vs. control  n  = 54""]",['integrated intervention program'],"['simple healthy meal index (SHMI), lunch quality (LQS), and diversity scores (LDS) calculated based on photographs of lunch trays', 'mean SHMI, LQS, and LDS', 'lunch healthy meal index, quality, and diversity', 'daily fruit intake', 'fruit and vegetable intake', 'LQS', 'Healthy Meal Index, Lunch Quality, and Diversity Scores']","[{'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0557648', 'cui_str': 'Dining room'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0184054', 'cui_str': 'Tray'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0556227', 'cui_str': 'Fruit intake'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}]",,0.0399714,"The mean SHMI, LQS, and LDS increased in the intervention group (0.51,  p  < 0.001; 0.27,  p  = 0.045; 0.95,  p  < 0.001, respectively) but not in the control group (","[{'ForeName': 'Ofira', 'Initials': 'O', 'LastName': 'Katz-Shufan', 'Affiliation': 'The S. Daniel Abraham International Center for Health and Nutrition, Department of Public Health, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva 8410501, Israel.'}, {'ForeName': 'Tzahit', 'Initials': 'T', 'LastName': 'Simon-Tuval', 'Affiliation': 'Department of Health Systems Management, Guilford Glazer Faculty of Business and Management and Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva 8410501, Israel.'}, {'ForeName': 'Liron', 'Initials': 'L', 'LastName': 'Sabag', 'Affiliation': 'The S. Daniel Abraham International Center for Health and Nutrition, Department of Public Health, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva 8410501, Israel.'}, {'ForeName': 'Danit', 'Initials': 'D', 'LastName': 'R Shahar', 'Affiliation': 'The S. Daniel Abraham International Center for Health and Nutrition, Department of Public Health, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva 8410501, Israel.'}]",Nutrients,['10.3390/nu12061741']
2063,32532144,Process Evaluation of a Clustered Randomized Control Trial of a Comprehensive Intervention to Reduce the Risk of Cardiovascular Events in Primary Health Care in Rural China.,"BACKGROUND


Cardiovascular disease (CVD) is a major public health challenge in China. This study aims to understand the processes of implementing a comprehensive intervention to reduce CVD events in areas of drug therapy, lifestyle changes, and adherence support in a clustered randomized controlled trial (cRCT). This trial consisted of 67 clusters spanning over 3 years in Zhejiang Province, China.
METHOD


A qualitative process evaluation was nested within the cRCT conducted in 9 township hospitals with 27 healthcare providers, 18 semi-structured interviews, and 23 observational studies of clinical practices within the intervention arm.
RESULTS


Effective and repeated trainings using an interactive approach were crucial to improve the prescribing behaviour of family doctors and their patient communication skills. However, the awareness of patients remained limited, thus compromising their use of CVD preventive drugs and adoption of healthy lifestyles. Health system factors further constrained providers' and patients' responses to the intervention. Financial barrier was a major concern because of the low coverage of health insurance. Other barriers included limited doctor-patient trust and suboptimal staff motivation.
CONCLUSION


Our study suggests the feasibility of implementing a comprehensive CVD risk reduction strategy in China's rural primary care facilities. However, health system barriers need to be addressed to ensure the success and sustainability of the intervention.",2020,"RESULTS


Effective and repeated trainings using an interactive approach were crucial to improve the prescribing behaviour of family doctors and their patient communication skills.","['9 township hospitals with 27 healthcare providers, 18 semi-structured interviews, and 23 observational studies of clinical practices within the intervention arm', 'Primary Health Care in Rural China', '67 clusters spanning over 3 years in Zhejiang Province, China', ""China's rural primary care facilities""]","['comprehensive intervention', 'Comprehensive Intervention', 'comprehensive CVD risk reduction strategy']","['prescribing behaviour of family doctors and their patient communication skills', 'Risk of Cardiovascular Events']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]","[{'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1704221', 'cui_str': 'Family medicine specialist'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.0934951,"RESULTS


Effective and repeated trainings using an interactive approach were crucial to improve the prescribing behaviour of family doctors and their patient communication skills.","[{'ForeName': 'Guanyang', 'Initials': 'G', 'LastName': 'Zou', 'Affiliation': 'School of Economics and Management, Guangzhou University of Chinese Medicine, Guangzhou 510006, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of STDs Prevention and Control, Dermatology Hospital, Southern Medical University, Guangzhou 510091, China.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'King', 'Affiliation': 'Nuffield Centre for International Health and Development, University of Leeds, Leeds LS2 9JT, UK.'}, {'ForeName': 'Zhitong', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Division of Clinical Epidemiology &Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, ON M5T 3M7, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Walley', 'Affiliation': 'Nuffield Centre for International Health and Development, University of Leeds, Leeds LS2 9JT, UK.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Gong', 'Affiliation': 'Zhejiang Provincial Centre for Disease Prevention and Control, Hangzhou 310052, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Zhejiang Provincial Centre for Disease Prevention and Control, Hangzhou 310052, China.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'Division of Clinical Epidemiology &Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, ON M5T 3M7, Canada.'}]",International journal of environmental research and public health,['10.3390/ijerph17114156']
2064,32532258,CXCR2 antagonist for patients with chronic obstructive pulmonary disease with chronic mucus hypersecretion: a phase 2b trial.,"BACKGROUND


Oral CXC chemokine receptor 2 (CXCR2) antagonists have been shown to inhibit neutrophil migration and activation in the lung in preclinical and human models of neutrophilic airway inflammation. A previous study with danirixin, a reversible CXCR2 antagonist, demonstrated a trend for improved respiratory symptoms and health status in patients with COPD.
METHODS


This 26-week, randomised, double-blind, placebo-controlled phase IIb study enrolled symptomatic patients with mild-to-moderate COPD at risk for exacerbations. Patients received danirixin 5, 10, 25, 35 or 50 mg twice daily or placebo in addition to standard of care. Primary end-points were the dose response of danirixin compared with placebo on the incidence and severity of respiratory symptoms (Evaluating Respiratory Symptoms in COPD [E-RS:COPD] scores) and safety. Secondary end-points included the incidence of moderate-severe exacerbations, health status (COPD Assessment test, CAT) and health-related quality of life HRQoL (St. George Respiratory Questionnaire-COPD, SGRQ-C).
RESULTS


A total of 614 participants were randomized to treatment. There were no improvements in E-RS:COPD, CAT or SGRQ-C scores in participants treated with any dose of danirixin compared to placebo; a larger than expected placebo effect was observed. There was an increased incidence of exacerbation in the danirixin-treated groups and an increased number of pneumonias in participants treated with danirixin 50 mg.
CONCLUSIONS


The robust placebo and study effects prohibited any conclusions on the efficacy of danirixin. However, the absence of a clear efficacy benefit and the observed increase in exacerbations in danirixin-treated groups suggests an unfavorable benefit-risk profile in patients with COPD.
TRIAL REGISTRATION


This study was registered with clinicaltrials.gov, NCT03034967.",2020,"There were no improvements in E-RS:COPD, CAT or SGRQ-C scores in participants treated with any dose of danirixin compared to placebo; a larger than expected placebo effect was observed.","['614 participants', 'controlled phase IIb study enrolled symptomatic patients with mild-to-moderate COPD at risk for exacerbations', 'patients with COPD', 'patients with chronic obstructive pulmonary disease with chronic mucus hypersecretion']","['danirixin', 'CXCR2 antagonist', 'placebo']","['number of pneumonias', 'respiratory symptoms and health status', 'dose response of danirixin', 'exacerbations', 'E-RS:COPD, CAT or SGRQ-C scores', 'incidence of exacerbation', 'incidence of moderate-severe exacerbations, health status (COPD Assessment test, CAT) and health-related quality of life HRQoL (St. George Respiratory Questionnaire-COPD, SGRQ-C', 'incidence and severity of respiratory symptoms (Evaluating Respiratory Symptoms in COPD [E-RS:COPD] scores) and safety']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0026727', 'cui_str': 'Mucus'}]","[{'cui': 'C4519256', 'cui_str': 'danirixin'}, {'cui': 'C0527994', 'cui_str': 'Interleukin-8B Receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4519256', 'cui_str': 'danirixin'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",614.0,0.583333,"There were no improvements in E-RS:COPD, CAT or SGRQ-C scores in participants treated with any dose of danirixin compared to placebo; a larger than expected placebo effect was observed.","[{'ForeName': 'Aili L', 'Initials': 'AL', 'LastName': 'Lazaar', 'Affiliation': 'GSK, Collegeville, PA, USA. aili.l.lazaar@gsk.com.'}, {'ForeName': 'Bruce E', 'Initials': 'BE', 'LastName': 'Miller', 'Affiliation': 'GSK, Collegeville, PA, USA.'}, {'ForeName': 'Alison C', 'Initials': 'AC', 'LastName': 'Donald', 'Affiliation': 'GSK, Collegeville, PA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Keeley', 'Affiliation': 'GSK - Stockley Park, Uxbridge, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Ambery', 'Affiliation': 'GSK - Stockley Park, Uxbridge, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Russell', 'Affiliation': 'GSK, Collegeville, PA, USA.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Watz', 'Affiliation': 'Pulmonary Research Institute Lungen Clinic Grosshansdorf, Airway Research Center North (ARCN), German Center for Lung Research (DZL) -, Grosshansdorf, Germany.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Tal-Singer', 'Affiliation': 'GSK, Collegeville, PA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Respiratory research,['10.1186/s12931-020-01401-4']
2065,32532262,High flow nasal therapy during early pulmonary rehabilitation in patients with acute severe exacerbation of COPD: beneficial or illusory?,"In study ""Effect of high-flow nasal therapy during early pulmonary rehabilitation in patients with severe AECOPD: a randomized controlled study"" by Tung et al., authors concluded HFNT utilization led to enhanced exercise tolerance and a reduction of systemic inflammation. Nevertheless, some points requires additional discussion, the conclusion of the trial seems overstated. The baseline differences between groups induces substantial modifications in the conclusions of this trial. HFNT does not seem to add any benefit on exercise tolerance or systemic inflammation, nor on pulmonary function. The only difference that remained significant in homogenous statistical significance is dyspnea on the mMRC scale but clinical significance is highly questionable.",2020,The only difference that remained significant in homogenous statistical significance is dyspnea on the mMRC scale but clinical significance is highly questionable.,"['patients with severe AECOPD', 'patients with acute severe exacerbation of COPD']","['High flow nasal therapy', 'HFNT', 'high-flow nasal therapy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.06232,The only difference that remained significant in homogenous statistical significance is dyspnea on the mMRC scale but clinical significance is highly questionable.,"[{'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Prieur', 'Affiliation': 'Institut de Recherche Expérimentale et Clinique (IREC), Pôle de Pneumologie, ORL & Dermatologie, Groupe de Recherche en Kinésithérapie Respiratoire, Université Catholique de Louvain, 1200, Brussels, Belgium. gprieur.kine@gmail.com.'}, {'ForeName': 'Yann', 'Initials': 'Y', 'LastName': 'Combret', 'Affiliation': 'Institut de Recherche Expérimentale et Clinique (IREC), Pôle de Pneumologie, ORL & Dermatologie, Groupe de Recherche en Kinésithérapie Respiratoire, Université Catholique de Louvain, 1200, Brussels, Belgium.'}, {'ForeName': 'Clement', 'Initials': 'C', 'LastName': 'Medrinal', 'Affiliation': 'Institute for Research and Innovation in Biomedicine (IRIB), Normandie Univ, UNIROUEN, EA3830-GRHV, 76000, Rouen, France.'}]",Respiratory research,['10.1186/s12931-020-01415-y']
2066,32532267,Efficacy of nano-carbonate apatite dentifrice in relief from dentine hypersensitivity following non-surgical periodontal therapy: a randomized controlled trial.,"BACKGROUND


Dentine hypersensitivity (DH) could occur or intensify after non-surgical periodontal therapy because of the exposure of dentine tubules, but currently no gold standard exists to treat DH. It has been demonstrated that nano-sized particles presented potential for dentine tubules blocking and remineralization. This randomized controlled trial aimed to investigate the efficacy of dentifrice containing nano-carbonate apatite (n-CAP) in reducing dentine hypersensitivity (DH) after non-surgical periodontal therapy.
METHODS


48 periodontitis patients with DH were included in this clinical trial. After non-surgical periodontal therapy, patients included were randomized to test and control group and the respective dentifrices were applied at chairside, after which they were instructed to brush teeth with the allocated dentifrices twice a day at home. Periodontal parameters were recorded at baseline and the last follow-up. DH was measured by air-blast test and recorded by visual analogue scale (VAS) and Schiff sensitivity scale at baseline, after polishing (0 week) and 2/4/6 weeks.
RESULTS


45 participants completed the follow-up. Periodontal parameters were improved and comparable between groups. Significant reduction in DH was observed in both groups at all time-points compared to baseline in terms of VAS and Schiff score. The test group achieved significantly greater relief from hypersensitivity compared with the control group after 4-week at-home use (for change of VAS, test group: 2.27 ± 2.47 versus control group: 1.68 ± 2.24, p = 0.036; for change of Schiff, test group: 0.94 ± 0.92 versus control group: 0.61 ± 0.83, p < 0.001). The 6-week results showed borderline significance between groups in terms of change of Schiff (p = 0.027) and no significance in terms of change of VAS (p = 0.256).
CONCLUSIONS


Home-use of n-CAP based dentifrice had some benefit on alleviation of DH following non-surgical periodontal therapy after 4 weeks compared to the control product.
TRIAL REGISTRATION


Chinese Clinical Trials Registry (No. ChiCTR-IPR-17011678, http://www.chictr.org.cn/, registered 16 June, 2017).",2020,Significant reduction in DH was observed in both groups at all time-points compared to baseline in terms of VAS and Schiff score.,"['48 periodontitis patients with DH', '45 participants completed the follow-up', 'dentine hypersensitivity following non-surgical periodontal therapy']","['nano-carbonate apatite dentifrice', 'dentifrice containing nano-carbonate apatite (n-CAP']","['DH', 'dentine hypersensitivity (DH', 'alleviation of DH', 'relief from hypersensitivity', 'change of VAS', 'Periodontal parameters', 'visual analogue scale (VAS) and Schiff sensitivity scale', 'change of Schiff']","[{'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0054675', 'cui_str': 'Carbapatite'}, {'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C2949227', 'cui_str': 'Schiff'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",48.0,0.0479244,Significant reduction in DH was observed in both groups at all time-points compared to baseline in terms of VAS and Schiff score.,"[{'ForeName': 'Pei-Hui', 'Initials': 'PH', 'LastName': 'Ding', 'Affiliation': 'Department of Periodontology, Affiliated Hospital of Stomatology, School of Medicine, Hangzhou, China.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Dai', 'Affiliation': 'Key Laboratory of Oral Biomedical Research of Zhejiang Province, Zhejiang University School of Stomatology, Hangzhou, China.'}, {'ForeName': 'Hua-Jiao', 'Initials': 'HJ', 'LastName': 'Hu', 'Affiliation': 'Key Laboratory of Oral Biomedical Research of Zhejiang Province, Zhejiang University School of Stomatology, Hangzhou, China.'}, {'ForeName': 'Jia-Ping', 'Initials': 'JP', 'LastName': 'Huang', 'Affiliation': 'Key Laboratory of Oral Biomedical Research of Zhejiang Province, Zhejiang University School of Stomatology, Hangzhou, China.'}, {'ForeName': 'Jia-Mei', 'Initials': 'JM', 'LastName': 'Liu', 'Affiliation': 'Key Laboratory of Oral Biomedical Research of Zhejiang Province, Zhejiang University School of Stomatology, Hangzhou, China.'}, {'ForeName': 'Li-Li', 'Initials': 'LL', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory of Oral Biomedical Research of Zhejiang Province, Zhejiang University School of Stomatology, Hangzhou, China. chenlili_1030@zju.edu.cn.'}]",BMC oral health,['10.1186/s12903-020-01157-9']
2067,32532275,"A phase IIb, randomised, parallel-group study: the efficacy, safety and tolerability of once-daily umeclidinium in patients with asthma receiving inhaled corticosteroids.","BACKGROUND


Patients with asthma uncontrolled on inhaled corticosteroids may benefit from umeclidinium (UMEC), a long-acting muscarinic antagonist.
METHODS


This Phase IIb, double-blind study included patients with reversible, uncontrolled/partially-controlled asthma for ≥6 months, receiving ≥100 mcg/day fluticasone propionate (or equivalent) for ≥12 weeks. Following a 2-week run-in on open-label fluticasone furoate (FF) 100 mcg, patients were randomised (1:1:1) to receive UMEC 31.25 mcg, UMEC 62.5 mcg or placebo on top of FF 100 mcg once-daily for 24 weeks. As-needed salbutamol was provided. Primary and secondary endpoints were change from baseline in clinic trough forced expiratory volume in 1 s (FEV 1 ) and clinic FEV 1  3 h post-dose, respectively, at Week 24. Other endpoints included change from baseline in home daily spirometry (trough FEV 1 , evening FEV 1 , morning [pre-dose] and evening peak expiratory flow) over 24 weeks. Safety was assessed throughout the study.
RESULTS


The intent-to-treat population comprised 421 patients (UMEC 31.25 mcg: n =139, UMEC 62.5 mcg: n =139, placebo: n =143). UMEC 31.25 mcg and 62.5 mcg demonstrated significantly greater improvements from baseline in clinic trough FEV 1  at Week 24 (difference [95% CI]: 0.176 L [0.092, 0.260; p<0.001] and 0.184 L [0.101, 0.268; p<0.001], respectively), clinic FEV 1  3 h post-dose at Week 24 (0.190 L [0.100, 0.279; p<0.001] and 0.198 L [0.109, 0.287; p<0.001], respectively) and mean change from baseline in daily home spirometry over 24 weeks versus placebo. No new safety signals were identified.
CONCLUSIONS


UMEC is a highly effective bronchodilator that leads to improved lung function when administered as a single bronchodilator on top of FF in subjects with fully reversible, uncontrolled/partially-controlled moderate asthma. These data support a favourable benefit/risk profile for UMEC (31.25 mcg and 62.5 mcg).
TRIAL REGISTRATION


GSK study ID: 205832; Clinicaltrials.gov ID: NCT03012061.",2020,"UMEC 31.25 mcg and 62.5 mcg demonstrated significantly greater improvements from baseline in clinic trough FEV 1  at Week 24 (difference [95% CI]: 0.176 L [0.092, 0.260; p<0.001] and 0.184 L [0.101, 0.268; p<0.001], respectively), clinic FEV 1  3 h post-dose at Week 24 (0.190 L [0.100, 0.279; p<0.001] and 0.198 L [0.109, 0.287; p<0.001], respectively) and mean change from baseline in daily home spirometry over 24 weeks versus placebo.","['patients with asthma receiving inhaled corticosteroids', 'Patients with asthma uncontrolled on inhaled', 'subjects with fully reversible, uncontrolled/partially-controlled moderate asthma', 'patients with reversible, uncontrolled/partially-controlled asthma for ≥6\u2009months, receiving ≥100 mcg/day', 'or equivalent) for ≥12\u2009weeks']","['UMEC 62.5 mcg: n =139, placebo', 'UMEC', 'fluticasone propionate', 'corticosteroids', 'UMEC 31.25 mcg, UMEC 62.5 mcg or placebo', 'open-label fluticasone furoate (FF', 'placebo']","['Safety', 'clinic trough forced expiratory volume in 1\u2009s (FEV 1 ) and clinic FEV 1  3\u2009h post-dose', 'clinic FEV', 'clinic trough FEV', 'lung function', 'home daily spirometry (trough FEV 1 , evening FEV 1 , morning [pre-dose] and evening peak expiratory flow', 'efficacy, safety and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C3853135', 'cui_str': 'Somewhat controlled'}, {'cui': 'C0581125', 'cui_str': 'Moderate asthma'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439426', 'cui_str': 'ug/day'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C3661274', 'cui_str': 'umeclidinium'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C4517704', 'cui_str': '31.25'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0439568', 'cui_str': 'Post-dose'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0439565', 'cui_str': 'Pre-dose'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.607591,"UMEC 31.25 mcg and 62.5 mcg demonstrated significantly greater improvements from baseline in clinic trough FEV 1  at Week 24 (difference [95% CI]: 0.176 L [0.092, 0.260; p<0.001] and 0.184 L [0.101, 0.268; p<0.001], respectively), clinic FEV 1  3 h post-dose at Week 24 (0.190 L [0.100, 0.279; p<0.001] and 0.198 L [0.109, 0.287; p<0.001], respectively) and mean change from baseline in daily home spirometry over 24 weeks versus placebo.","[{'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Kerwin', 'Affiliation': 'Crisor LLC Research, Clinical Research Institute of Southern Oregon, Medford, OR, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Pascoe', 'Affiliation': 'GSK, Upper Providence, PA, USA.'}, {'ForeName': 'Zelie', 'Initials': 'Z', 'LastName': 'Bailes', 'Affiliation': 'GSK, Stockley Park West, Uxbridge, Middlesex, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Nathan', 'Affiliation': 'Asthma & Allergy Associates, P.C. and Research Center, Colorado Springs, CO, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bernstein', 'Affiliation': 'Division of Immunology, Allergy and Rheumatology, University of Cincinnati College of Medicine, Cincinnati, OH, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Dahl', 'Affiliation': 'GSK, 980 Great West Road, Brentford, Middlesex, UK.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'von Maltzahn', 'Affiliation': 'GSK, Stockley Park West, Uxbridge, Middlesex, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Robbins', 'Affiliation': 'GSK, Upper Providence, PA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fowler', 'Affiliation': 'GSK, Stockley Park West, Uxbridge, Middlesex, UK.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Lee', 'Affiliation': 'GSK, Upper Providence, PA, USA. laurie.myers.lee@gmail.com.'}]",Respiratory research,['10.1186/s12931-020-01400-5']
2068,32532280,Monetary incentives and peer referral in promoting digital network-based secondary distribution of HIV self-testing among men who have sex with men in China: study protocol for a three-arm randomized controlled trial.,"BACKGROUND


Human immunodeficiency virus (HIV) testing is a crucial strategy for HIV prevention. HIV testing rates remain low among men who have sex with men (MSM) in China. Digital network-based secondary distribution is considered as an effective model to enhance HIV self-testing (HIVST) among key populations. Digital platforms provide opportunities for testers to apply for HIVST kits by themselves, and secondary distribution allows them to apply for multiple kits to deliver to their sexual partners or members within their social network. We describe a three-arm randomized controlled trial to examine the effect of monetary incentives and peer referral in promoting digital network-based secondary distribution of HIVST among MSM in China.
METHODS


Three hundred MSM in China will be enrolled through a digital platform for data collection. The eligibility criteria include being biological male, 18 years of age or over, ever having had sex with another man, being able to apply for kits via the online platform, and being willing to provide personal telephone number for follow-up. Eligible participants will be randomly allocated into one of the three arms: standard secondary distribution arm, secondary distribution with monetary incentives arm, and secondary distribution with monetary incentives plus peer referral arm. Participants (defined as ""index"") will distribute actual HIV self-test kits to members within their social network (defined as ""alter"") or share referral links to encourage alters to apply HIV self-test kits by themselves. All index participants will be requested to complete a baseline survey and a 3-month follow-up survey. Both indexes and alters will complete a survey upon returning the results by taking a photo of the used kits with the unique identification number.
DISCUSSION


HIV testing rates remain suboptimal among MSM in China. Innovative interventions are needed to further expand the uptake of HIV testing among key populations. The findings of the trial can provide scientific evidence and experience on promoting secondary distribution of HIVST to reach key populations who have not yet been covered by existing testing services.
TRIAL REGISTRATION


The study was registered in the Chinese Clinical Trial Registry (ChiCTR1900025433) on 26, August 2019, http://www.chictr.org.cn/showproj.aspx?proj=42001. Prospectively registered.",2020,"We describe a three-arm randomized controlled trial to examine the effect of monetary incentives and peer referral in promoting digital network-based secondary distribution of HIVST among MSM in China.
","['men who have sex with men (MSM) in China', 'men who have sex with men in China', 'The eligibility criteria include being biological male, 18\u2009years of age or over, ever having had sex with another man, being able to apply for kits via the online platform, and being willing to provide personal telephone number for follow-up', 'Eligible participants']","['standard secondary distribution arm, secondary distribution with monetary incentives arm, and secondary distribution with monetary incentives plus peer referral arm', 'monetary incentives and peer referral']",[],"[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C1515258', 'cui_str': 'Telephone number (property)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}]",[],,0.157662,"We describe a three-arm randomized controlled trial to examine the effect of monetary incentives and peer referral in promoting digital network-based secondary distribution of HIVST among MSM in China.
","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China.'}, {'ForeName': 'Yuxin', 'Initials': 'Y', 'LastName': 'Ni', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Zhuhai Center for Diseases Control and Prevention, Zhuhai, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Zhuhai Xutong Voluntary Services Center, Zhuhai, China.'}, {'ForeName': 'Shanzi', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Zhuhai Center for Diseases Control and Prevention, Zhuhai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Zhuhai Center for Diseases Control and Prevention, Zhuhai, China.'}, {'ForeName': 'Wencan', 'Initials': 'W', 'LastName': 'Dai', 'Affiliation': 'Zhuhai Center for Diseases Control and Prevention, Zhuhai, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tucker', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Guangquan', 'Initials': 'G', 'LastName': 'Shen', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China.'}, {'ForeName': 'Yongjie', 'Initials': 'Y', 'LastName': 'Sha', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Guangdong Pharmaceutical University, Guangzhou, China.'}, {'ForeName': 'Liqun', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Zhuhai Center for Diseases Control and Prevention, Zhuhai, China.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China. weiming_tang@med.unc.edu.'}]",BMC public health,['10.1186/s12889-020-09048-y']
2069,32532283,Effectiveness of inspiratory muscle training associated with a cardiac rehabilitation program on sympathetic activity and functional capacity in patients with heart failure: a study protocol for a randomized controlled trial.,"BACKGROUND


Individuals affected by heart failure (HF) may present fatigue, dyspnea, respiratory muscle weakness, and sympathetic activity hyperstimulation of the myocardium, among other symptoms. Conducting cardiac rehabilitation (CR) programs can be associated with inspiratory muscle training. The aim of this study was to evaluate the efficacy of inspiratory muscular training (IMT) associated with a CR program on modulating myocardial sympathetic activity and maximal functional capacity, submaximal functional capacity, thickness, and mobility of the diaphragm muscle in patients with HF.
METHODS


We will conduct a clinical, controlled, randomized, double-blind trial that will include sedentary men and women who are 21-60 years old and who have diagnosed systolic HF and a left ventricular ejection fraction of less than 45%. Participants will be randomly assigned to one of two groups: experimental and control. The control group will follow the conventional CR protocol, and the experimental group will follow the conventional CR protocol associated with IMT 7 days a week. The two proposed exercise protocols will have a frequency of three times a week for a period of 12 weeks. The sympathetic innervation of the cardiac muscle, the maximum and submaximal functional capacity, diaphragm mobility and thickness, and the quality of life of the participants will be evaluated before and after the intervention protocol.
DISCUSSION


This clinical trial will be the first study to investigate the additional effects of IMT on CR in sympathetic hyperstimulation in the myocardium. The results of this study will contribute to developing therapeutic strategies collaborating to elucidate whether the association of IMT with CR can induce clinical benefits for patients with HF.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT02600000. Registered November 9, 2015. Retrospectively registered.",2020,"The sympathetic innervation of the cardiac muscle, the maximum and submaximal functional capacity, diaphragm mobility and thickness, and the quality of life of the participants will be evaluated before and after the intervention protocol.
","['patients with HF', 'patients with heart failure', 'sedentary men and women who are 21-60\u2009years old and who have diagnosed systolic HF and a left ventricular ejection fraction of less than\u200945']","['CR program', 'Conducting cardiac rehabilitation (CR) programs', 'inspiratory muscular training (IMT', 'inspiratory muscle training', 'cardiac rehabilitation program', 'IMT']","['maximum and submaximal functional capacity, diaphragm mobility and thickness, and the quality of life', 'sympathetic activity and functional capacity', 'myocardial sympathetic activity and maximal functional capacity, submaximal functional capacity, thickness, and mobility of the diaphragm muscle']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1135191', 'cui_str': 'Systolic heart failure'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0439092', 'cui_str': '<'}]","[{'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}]",,0.102654,"The sympathetic innervation of the cardiac muscle, the maximum and submaximal functional capacity, diaphragm mobility and thickness, and the quality of life of the participants will be evaluated before and after the intervention protocol.
","[{'ForeName': 'Jéssica Costa', 'Initials': 'JC', 'LastName': 'Leite', 'Affiliation': 'Department of Physiotherapy, Universidade Federal do Rio Grande do Norte, Av. Senador Salgado Filho, s/n, Natal, 59078-970, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Daniella Cunha', 'Initials': 'DC', 'LastName': 'Brandão', 'Affiliation': 'Department of Physiotherapy, Universidade Federal de Pernambuco, Av. Jornalista Aníbal Fernandes, s / n, Recife, Pernambuco, 50740-560, Brazil. daniellacunha@hotmail.com.'}, {'ForeName': 'Simone Cristina Soares', 'Initials': 'SCS', 'LastName': 'Brandão', 'Affiliation': 'Nuclear Medicine and Cardiology Services, Hospital das Clínicas de Pernambuco, Universidade Federal de Pernambuco, Av. Prof. Moraes Rego, 1235, Recife, 50670-901, Pernambuco, Brazil.'}, {'ForeName': 'Helen Kerlen Bastos', 'Initials': 'HKB', 'LastName': 'Fuzari', 'Affiliation': 'Department of Physiotherapy, Universidade Federal de Pernambuco, Av. Jornalista Aníbal Fernandes, s / n, Recife, Pernambuco, 50740-560, Brazil.'}, {'ForeName': 'Tainá Maria', 'Initials': 'TM', 'LastName': 'Vidal', 'Affiliation': 'Department of Physiotherapy, Universidade Federal de Pernambuco, Av. Jornalista Aníbal Fernandes, s / n, Recife, Pernambuco, 50740-560, Brazil.'}, {'ForeName': 'Jasiel', 'Initials': 'J', 'LastName': 'Frutuoso', 'Affiliation': 'Department of Physiotherapy, Universidade Federal de Pernambuco, Av. Jornalista Aníbal Fernandes, s / n, Recife, Pernambuco, 50740-560, Brazil.'}, {'ForeName': 'Maria Inês', 'Initials': 'MI', 'LastName': 'Remígio', 'Affiliation': 'Department of Clinical Semiology of the Medicine Faculty, Universidade Federal de Pernambuco, Av. Jornalista Aníbal Fernandes, s / n, Cidade Universitária, Recife, 50740-560, Pernambuco, Brazil.'}, {'ForeName': 'Bruna Thays Santana', 'Initials': 'BTS', 'LastName': 'de Araújo', 'Affiliation': 'Department of Physiotherapy, Universidade Federal de Pernambuco, Av. Jornalista Aníbal Fernandes, s / n, Recife, Pernambuco, 50740-560, Brazil.'}, {'ForeName': 'Shirley Lima', 'Initials': 'SL', 'LastName': 'Campos', 'Affiliation': 'Department of Physiotherapy, Universidade Federal de Pernambuco, Av. Jornalista Aníbal Fernandes, s / n, Recife, Pernambuco, 50740-560, Brazil.'}, {'ForeName': 'Armele', 'Initials': 'A', 'LastName': 'Dornelas de Andrade', 'Affiliation': 'Department of Physiotherapy, Universidade Federal do Rio Grande do Norte, Av. Senador Salgado Filho, s/n, Natal, 59078-970, Rio Grande do Norte, Brazil.'}]",Trials,['10.1186/s13063-020-04363-6']
2070,32532310,"Ropivacaine 75 mg versus placebo in perineal infiltration for analgesic efficacy at mid- and long-term for episiotomy repair in postpartum women - the ROPISIO study: a two-center, randomized, double-blind, placebo-controlled trials.","BACKGROUND


Perineal pain due to episiotomy is commonly reported and can be severe enough to disturb the mother-infant dyad during the postpartum period. Its incidence at day 7 postpartum varies from 63% to 74%. Recent studies have investigated the analgesic efficacy of perineal infiltration of ropivacaine after episiotomy but have only focused on the immediate postpartum period (at 24 and 48 h after birth). Large, adequately powered, multicenter, randomized controlled trials are required to evaluate the impact of ropivacaine infiltration on perineal pain and mid- and long-term quality of life before the widespread use of ropivacaine to prevent perineal pain after episiotomy can be recommended.
METHODS/DESIGN


The ROPISIO study is a two-center, randomized, double-blind, placebo-controlled trial being conducted in La Roche sur Yon and Nantes, France. It will involve 272 women with vaginal singleton delivery and mediolateral episiotomy at term (≥ 37 weeks). Perineal infiltration (ropivacaine 75 mg or placebo) will be administrated just after vaginal birth and before episiotomy repair. The primary outcome will be the analgesic efficacy at day 7 postpartum (midterm), defined by the Numeric Pain Rating Scale (NPRS) strictly superior to 3/10 on the perineal repair area. Secondary outcomes will be the analgesic efficacy (NPRS) and the impact of pain on daily behavior, on the quality of life (36-item Short Form Health Survey), on the occurrence of symptoms of postpartum depression (Edinburgh Postnatal Depression Scale), and on sexual health (Female Sexual Function Index) at 3 and 6 months (long-term) using validated online questionnaires. This study will have 90% power to show approximately 30% relative risk reduction in the incidence of perineal pain at day 7, from 70.0% to 50.0%.
DISCUSSION


Ropivacaine is a promising candidate drug, inexpensive, and easy to administer, and it would be suitable to include in the routine management of deliveries in labor ward. This study will investigate if perineal ropivacaine infiltration just after birth can reduce mid- and long-term postpartum pain and increase quality of life in women with mediolateral episiotomy.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03084549. Registered on 14 April 2017.",2020,It will involve 272 women with vaginal singleton delivery and mediolateral episiotomy at term (≥ 37 weeks).,"['272 women with vaginal singleton delivery and mediolateral episiotomy at term (≥\u200937\u2009weeks', 'women with mediolateral episiotomy']","['Perineal infiltration (ropivacaine 75\u2009mg or placebo', 'ropivacaine', 'perineal ropivacaine', 'Ropivacaine', 'placebo']","['quality of life', 'analgesic efficacy (NPRS) and the impact of pain on daily behavior, on the quality of life (36-item Short Form Health Survey), on the occurrence of symptoms of postpartum depression (Edinburgh Postnatal Depression Scale), and on sexual health (Female Sexual Function Index', 'perineal pain and mid- and long-term quality of life', 'analgesic efficacy at day 7 postpartum (midterm), defined by the Numeric Pain Rating Scale (NPRS) strictly superior to 3/10 on the perineal repair area', 'analgesic efficacy', 'perineal pain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0235641', 'cui_str': 'Pain in female perineum'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",272.0,0.431623,It will involve 272 women with vaginal singleton delivery and mediolateral episiotomy at term (≥ 37 weeks).,"[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Cardaillac', 'Affiliation': 'Department of Obstetrics and Gynecology and Reproductive Medicine, Nantes University Hospital, 44000, Nantes, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Ploteau', 'Affiliation': 'Department of Obstetrics and Gynecology and Reproductive Medicine, Nantes University Hospital, 44000, Nantes, France.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Le Thuaut', 'Affiliation': 'Clinical Research Centre, Centre Hospitalier Departemental, 85000, La Roche sur Yon, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Dochez', 'Affiliation': 'Department of Obstetrics and Gynecology and Reproductive Medicine, Nantes University Hospital, 44000, Nantes, France.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Winer', 'Affiliation': 'Department of Obstetrics and Gynecology and Reproductive Medicine, Nantes University Hospital, 44000, Nantes, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Ducarme', 'Affiliation': 'Department of Obstetrics and Gynecology, Centre Hospitalier Departemental, 85000, La Roche sur Yon, France. g.ducarme@gmail.com.'}]",Trials,['10.1186/s13063-020-04423-x']
2071,32532313,A feasibility study of a WhatsApp-delivered Transtheoretical Model-based intervention to promote healthy eating habits for firefighters in Hong Kong: a cluster randomized controlled trial.,"BACKGROUND


Firefighters' health is often affected by a high prevalence of obesity and cardiovascular diseases, which are common risk factors for sudden cardiac death. The aim of this study is to investigate the feasibility of enhancing healthy eating habits in firefighters through an education programme.
METHODS


This will be a cluster randomized control trial study. The participants will be assigned randomly into either control (health promotion pamphlet) or intervention (health promotion pamphlet and education materials through WhatsApp) groups. Changes in healthy eating habits will be assessed by a self-administered questionnaire and anthropometric measurements at three different time points.
DISCUSSION


More education is required in order to improve firefighters' eating habits.
TRIAL REGISTRATION


ISRCTN registry identifier: Registered on 8 April 2019 ISRCTN95472464.",2020,"The aim of this study is to investigate the feasibility of enhancing healthy eating habits in firefighters through an education programme.
",['healthy eating habits for firefighters in Hong Kong'],"['WhatsApp-delivered Transtheoretical Model-based intervention', 'control (health promotion pamphlet) or intervention (health promotion pamphlet and education materials through WhatsApp']",['healthy eating habits'],"[{'cui': 'C0016468', 'cui_str': 'Eating Habits'}, {'cui': 'C0221459', 'cui_str': 'Fire fighter'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}]","[{'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]",,0.150693,"The aim of this study is to investigate the feasibility of enhancing healthy eating habits in firefighters through an education programme.
","[{'ForeName': 'Wing Man', 'Initials': 'WM', 'LastName': 'Ng', 'Affiliation': 'Division of Science, Engineering and Health Studies, College of Professional and Continuing Education, The Hong Kong Polytechnic University, Hung Hom, Hong Kong. winnie.ng@cpce-polyu.edu.hk.'}, {'ForeName': 'Kin', 'Initials': 'K', 'LastName': 'Cheung', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong.'}]",Trials,['10.1186/s13063-020-04258-6']
2072,32532321,"Corneal cross-linking versus standard care in children with keratoconus - a randomised, multicentre, observer-masked trial of efficacy and safety (KERALINK): a statistical analysis plan.","BACKGROUND


The KERALINK trial tests the hypothesis that corneal cross-linking (CXL) treatment reduces the progression of keratoconus in comparison to standard care in patients aged 10-16 years. This article describes the statistical analysis plan for this trial as an update to the published protocol. It is written before the end of the patient follow-up, while the outcome of the trial is still unknown.
DESIGN AND METHODS


KERALINK is a randomised controlled, observer-masked, multicentre trial in progressive keratoconus comparing epithelium-off CXL with standard care, including spectacles or contact lenses as necessary for best-corrected acuity. Keratoconus is a disorder of the shape of the cornea in which the normally round dome-shaped clear front window of the eye (cornea) thins progressively leading to a cone-like bulge. This impairs the ability of the eye to focus properly, causing reduced vision which requires spectacle or contact lens wear or, in a minority of patients, eventually corneal replacement by a transplant for best vision. The primary outcome measure is the between-group difference in K 2  at 18 months adjusted for K 2  at baseline examination. K 2  is the value of the steepest corneal meridian as measured on Pentacam topography. Secondary outcomes are keratoconus progression, time to keratoconus progression, visual acuity, refraction, apical corneal thickness and adverse events. Patient-reported effects will be explored by questionnaires. We describe in detail the statistical aspects of KERALINK: the outcome measures, the sample size calculation, general analysis principles, the planned descriptive statistics and statistical models, and planned subgroup and sensitivity analyses.
DISCUSSION


The KERALINK statistical analysis will provide comprehensive and precise information on the relative effectiveness of the two treatments. The plan will be implemented in May 2020 when follow-up for the trial is completed.
TRIAL REGISTRATION


EudraCT, 2016-001460-11. Registered on 19 May 2016.",2020,The primary outcome measure is the between-group difference in K 2  at 18 months adjusted for K 2  at baseline examination.,"['patients aged 10-16\u2009years', 'children with keratoconus ']","['CXL with standard care, including spectacles or contact lenses', 'corneal cross-linking (CXL', 'Corneal cross-linking versus standard care']","['keratoconus progression, time to keratoconus progression, visual acuity, refraction, apical corneal thickness and adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0022578', 'cui_str': 'Keratoconus'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0009836', 'cui_str': 'Contact lenses'}, {'cui': 'C4728129', 'cui_str': 'Corneal cross linking'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}]","[{'cui': 'C0022578', 'cui_str': 'Keratoconus'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0429493', 'cui_str': 'Corneal thickness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.148283,The primary outcome measure is the between-group difference in K 2  at 18 months adjusted for K 2  at baseline examination.,"[{'ForeName': 'Kashfia', 'Initials': 'K', 'LastName': 'Chowdhury', 'Affiliation': 'Comprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK. k.chowdhury@ucl.ac.uk.'}, {'ForeName': 'Caroline J', 'Initials': 'CJ', 'LastName': 'Doré', 'Affiliation': 'Comprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Catey', 'Initials': 'C', 'LastName': 'Bunce', 'Affiliation': ""School of Population Health and Environmental Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Daniel F P', 'Initials': 'DFP', 'LastName': 'Larkin', 'Affiliation': 'NIHR Moorfields Clinical Research Facility, Moorfields Eye Hospital, London, UK.'}]",Trials,['10.1186/s13063-020-04392-1']
2073,32532328,Pressure pain threshold and temporal summation in adults with episodic and persistent low back pain trajectories: a secondary analysis at baseline and after lumbar manipulation or sham.,"BACKGROUND


People with chronic low back pain (LBP) typically have increased pain sensitivity compared to healthy controls, however its unknown if pain sensitivity differs based on LBP trajectory at baseline or after manual therapy interventions. We aimed to compare baseline pressure pain threshold (PPT) and temporal summation (TS) between people without LBP, with episodic LBP, and with persistent LBP, and to compare changes over time in PPT and TS after a lumbar spinal manipulation or sham manipulation in those with LBP.
METHODS


Participants were aged 18-59, with or without LBP. Those with LBP were categorised as having either episodic or persistent LBP. PPT and TS were tested at baseline. LBP participants then received a lumbar spinal manipulation or sham, after which PPT and TS were re-tested three times over 30 min. Generalised linear mixed models were used to analyse data.
RESULTS


One hundred participants (49 female) were included and analysed. There were 20 non-LBP participants (mean age 31 yrs), 23 episodic LBP (mean age 35 yrs), and 57 persistent LBP (mean age 37 yrs). There were no significant differences in PPT or TS between groups at baseline. There was a non-significant pattern of lower PPT (higher sensitivity) from the non-LBP group to the persistent LBP group at baseline, and high variability. Changes in PPT and TS after the interventions did not differ between the two LBP groups.
DISCUSSION


We found no differences between people with no LBP, episodic LBP, or persistent LBP in baseline PPT or TS. Changes in PPT and TS following a lumbar manual therapy intervention do not appear to differ between LBP trajectories.
TRIAL REGISTRATION


The trial was prospectively registered with ANZCTR (ACTRN12617001094369).",2020,"There was a non-significant pattern of lower PPT (higher sensitivity) from the non-LBP group to the persistent LBP group at baseline, and high variability.","['people without LBP, with episodic LBP, and with persistent LBP', 'One hundred participants (49 female) were included and analysed', 'Participants were aged 18-59, with or without LBP', '20 non-LBP participants (mean age 31\u2009yrs), 23 episodic LBP (mean age 35\u2009yrs), and 57 persistent LBP (mean age 37\u2009yrs', 'adults with episodic and persistent low back pain trajectories', 'People with chronic low back pain (LBP']","['LBP', 'lumbar spinal manipulation']","['PPT or TS', 'pain sensitivity', 'Pressure pain threshold and temporal summation', 'baseline pressure pain threshold (PPT) and temporal summation (TS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0086586', 'cui_str': 'Manipulation of spine'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation'}, {'cui': 'C0443150', 'cui_str': 'Baseline pressure'}]",100.0,0.151039,"There was a non-significant pattern of lower PPT (higher sensitivity) from the non-LBP group to the persistent LBP group at baseline, and high variability.","[{'ForeName': 'Sasha L', 'Initials': 'SL', 'LastName': 'Aspinall', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, 90 South St, Murdoch, WA, 6150, Australia. sasha.aspinall@murdoch.edu.au.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Jacques', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, 90 South St, Murdoch, WA, 6150, Australia.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Leboeuf-Yde', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, 90 South St, Murdoch, WA, 6150, Australia.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Etherington', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, 90 South St, Murdoch, WA, 6150, Australia.'}, {'ForeName': 'Bruce F', 'Initials': 'BF', 'LastName': 'Walker', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, 90 South St, Murdoch, WA, 6150, Australia.'}]",Chiropractic & manual therapies,['10.1186/s12998-020-00326-5']
2074,32508327,"Additional Safety and Exploratory Efficacy Data at 48 and 60 Months from Open-HART, an Open-Label Extension Study of Pridopidine in Huntington Disease.","BACKGROUND


Open-HART was an open-label extension of HART, a randomized, double-blind, placebo-controlled study of pridopidine in Huntington disease (HD). Previously, we reported safety and exploratory efficacy data after 36 months of treatment with pridopidine 45 mg twice daily. In the interim, emerging data suggests pridopidine may have neuroprotective effects mediated by sigma-1 receptor agonism.
OBJECTIVE


To report additional safety and exploratory efficacy data for continued open-label use of 45 mg BID pridopidine at 48 and 60 months.
METHODS


Patients in Open-HART were followed up to or greater than 60 months. Adverse events, concomitant medications, vital signs, laboratory values, and ECG data were monitored. Rates of decline in total functional capacity (TFC) and total motor score (TMS) over 60 months were evaluated in an exploratory analysis and compared between Open-HART and placebo recipients from the 2CARE trial. To account for missing data, sensitivity analyses were performed.
RESULTS


Of the original Open-HART baseline cohort (N = 118), 40 remained in the study at 48 months and 33 at 60 months. Pridopidine remained safe and well tolerated over the 60-month interval. TFC and TMS at 48 and 60 months remained stable, showing less decline at these timepoints compared to historical placebo controls from the 2CARE trial. TFC differences at 48 and 60 months observed remained nominally significant after sensitivity analysis.
CONCLUSION


The 45 mg BID pridopidine dosage remained safe and tolerable over 60 months. Exploratory analyses show TFC and TMS stability at 48 and 60 months, in contrast to placebo historical controls from the 2CARE trial. Results are consistent with data reported from the recent Phase 2 PRIDE-HD trial showing less functional decline in the pridopidine 45 mg BID treated group at 52 weeks.",2020,"TFC and TMS at 48 and 60 months remained stable, showing less decline at these timepoints compared to historical placebo controls from the 2CARE trial.","['Huntington disease (HD', 'N\u200a=\u200a118', 'Patients in Open-HART were followed up to or greater than 60 months', 'in Huntington Disease']","['TFC and TMS', '45\u200amg BID pridopidine', 'pridopidine', 'Pridopidine', 'placebo']","['TFC and TMS stability', 'total functional capacity (TFC) and total motor score (TMS', 'safe and well tolerated', 'TFC differences', 'Adverse events, concomitant medications, vital signs, laboratory values, and ECG data']","[{'cui': 'C0020179', 'cui_str': ""Huntington's chorea""}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C1741584', 'cui_str': 'pridopidine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}]",,0.101185,"TFC and TMS at 48 and 60 months remained stable, showing less decline at these timepoints compared to historical placebo controls from the 2CARE trial.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McGarry', 'Affiliation': 'Cooper University Health Care at Rowan University, Camden, NJ, USA.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Auinger', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Kieburtz', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Geva', 'Affiliation': 'Prilenia Therapeutics, Herzliya, Israel.'}, {'ForeName': 'Munish', 'Initials': 'M', 'LastName': 'Mehra', 'Affiliation': 'Tigermed Data Solutions, Bengaluru, Karnataka, India.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Abler', 'Affiliation': 'Teva Pharmaceutical Industries, Kansas City, MO, USA.'}, {'ForeName': 'Igor D', 'Initials': 'ID', 'LastName': 'Grachev', 'Affiliation': 'Teva Pharmaceutical Industries, Kansas City, MO, USA.'}, {'ForeName': 'Mark Forrest', 'Initials': 'MF', 'LastName': 'Gordon', 'Affiliation': 'Teva Pharmaceutical Industries, Kansas City, MO, USA.'}, {'ForeName': 'Juha-Matti', 'Initials': 'JM', 'LastName': 'Savola', 'Affiliation': 'Teva Pharmaceuticals International GmbH, Basel, Switzerland.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Gandhi', 'Affiliation': 'Teva Pharmaceutical Industries, Kansas City, MO, USA.'}, {'ForeName': 'Spyridon', 'Initials': 'S', 'LastName': 'Papapetropoulos', 'Affiliation': 'Teva Pharmaceutical Industries, Frazer, PA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hayden', 'Affiliation': 'Prilenia Therapeutics, Herzliya, Israel.'}]",Journal of Huntington's disease,['10.3233/JHD-190393']
2075,32505485,Neuroplastic changes in resting-state functional connectivity after rTMS intervention for methamphetamine craving.,"Amphetamine-type stimulants are the second most commonly abused illicit drug worldwide, with no effective medical treatments currently available. Previous studies have demonstrated that high frequency repetitive transcranial magnetic stimulation (rTMS) over the left dorsolateral prefrontal cortex (DLPFC) reduced cue-induced craving in patients with methamphetamine dependence. However, the neuroplastic mechanism underlying rTMS intervention in methamphetamine users remains to be elucidated. Sixty participants (40 males) with severe methamphetamine use disorder according to DSM-5 were randomized to receive either intermittent theta burst protocols (iTBS) (short bursts of 50 Hz rTMS repeated at a rate in the theta range (5 Hz), 2-sec on, 8-sec off for 5 min; 900 pulses) or sham rTMS over the DLPFC over four weeks (20 daily sessions). Resting state functional connectivity magnetic resonance imaging was acquired before and after rTMS intervention. Participants received drug related cue exposure and rated their craving before and after stimulation. Seed-based functional connectivity analysis was performed to probe rTMS-induced neuroplastic reorganization of brain functional networks. Results showed that twenty daily rTMS sessions decreased craving, increased functional connectivity between left DLPFC and inferior parietal lobule, and decreased functional connectivity between insula and inferior parietal lobule, medial temporal lobe and precuneus. Moreover, the increase of functional connectivity between DLPFC and inferior parietal lobule correlated with craving reduction. This study suggests that neuroplastic changes of frontoparietal functional connectivity contributes to craving reduction, shedding light on the therapeutic effect of rTMS on methamphetamine use disorder.",2020,"Results showed that twenty daily rTMS sessions decreased craving, increased functional connectivity between left DLPFC and inferior parietal lobule, and decreased functional connectivity between insula and inferior parietal lobule, medial temporal lobe and precuneus.","['patients with methamphetamine dependence', 'Sixty participants (40 males) with severe methamphetamine use disorder according to DSM-5']","['intermittent theta burst protocols (iTBS) (short bursts of 50\u202fHz rTMS repeated at a rate in the theta range (5\u202fHz), 2-sec on, 8-sec off for 5\u202fmin; 900 pulses) or sham rTMS', 'rTMS', 'rTMS intervention', 'repetitive transcranial magnetic stimulation (rTMS', 'Amphetamine-type stimulants']","['craving, increased functional connectivity between left DLPFC and inferior parietal lobule, and decreased functional connectivity between insula and inferior parietal lobule, medial temporal lobe and precuneus', 'functional connectivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1533217', 'cui_str': 'Methamphetamine dependence'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0059387', 'cui_str': 'staphylococcal enterotoxin C'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0152304', 'cui_str': 'Inferior parietal lobule structure'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0039485', 'cui_str': 'Temporal lobe structure'}]",60.0,0.0225991,"Results showed that twenty daily rTMS sessions decreased craving, increased functional connectivity between left DLPFC and inferior parietal lobule, and decreased functional connectivity between insula and inferior parietal lobule, medial temporal lobe and precuneus.","[{'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yilin', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Institute of Neuroscience, CAS Center for Excellence in Brain Science and Intelligence Technology, State Key Laboratory of Neuroscience, CAS Key Laboratory of Primate Neurobiology, Chinese Academy of Sciences, Shanghai, China; University of Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Dazhi', 'Initials': 'D', 'LastName': 'Yin', 'Affiliation': 'School of Psychology and Cognitive Science, East China Normal University, Shanghai, China.'}, {'ForeName': 'Tianzhen', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaotong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhong', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jijun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Xiao', 'Affiliation': 'Shanghai Drug Rehabilitation Administration Bureau, Shanghai, China.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': 'Shanghai Drug Rehabilitation Administration Bureau, Shanghai, China.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Zeljic', 'Affiliation': 'Institute of Neuroscience, CAS Center for Excellence in Brain Science and Intelligence Technology, State Key Laboratory of Neuroscience, CAS Key Laboratory of Primate Neurobiology, Chinese Academy of Sciences, Shanghai, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Institute of Neuroscience, CAS Center for Excellence in Brain Science and Intelligence Technology, State Key Laboratory of Neuroscience, CAS Key Laboratory of Primate Neurobiology, Chinese Academy of Sciences, Shanghai, China; University of Chinese Academy of Sciences, Beijing, China; CAS Center for Excellence in Brain Science and Intelligence Technology, Chinese Academy of Sciences, Shanghai, 200031, China. Electronic address: zheng.wang@ion.ac.cn.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; CAS Center for Excellence in Brain Science and Intelligence Technology, Chinese Academy of Sciences, Shanghai, 200031, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China; Institute of Psychological and Behavioral Science, Shanghai Jiao Tong University, Shanghai, China. Electronic address: drminzhao@smhc.org.cn.'}]",Neuropharmacology,['10.1016/j.neuropharm.2020.108177']
2076,32511251,Efficacy of intravenous iron treatment for chemotherapy-induced anemia: A prospective Phase II pilot clinical trial in South Korea.,"BACKGROUND


Anemia is the most common and serious cancer-related complication. This study aimed to evaluate the efficacy of administration of ferric carboxymaltose without erythropoiesis-stimulating agents for treating anemia in cancer patients. Moreover, we identified the biomarkers of hemoglobin response to predict the need for iron therapy.
METHODS AND FINDINGS


We enrolled patients with solid cancers who were treated at a single institute (Samsung Medical Center, South Korea), from April 2015 to July 2017, in this prospective single-arm Phase II clinical trial. Patients received intravenous ferric carboxymaltose (1,000 mg) infusion on the first day (visit 1) of treatment. The primary end point was the number of hemoglobin responders, defined as patients with an increase in hemoglobin level ≥ 1.0 g/dL from the baseline, a hemoglobin level ≥ 11.0 g/dL, or both, within an 8-week observation period (week 3, 6, or 8). Secondary end points included changes in transferrin saturation and levels of soluble transferrin receptors, hepcidin, erythropoietin, interleukin-6, and C-reactive protein (CRP) at each visit. Of the 103 recruited patients, 92 were eligible for analysis. The mean patient age was 57.3 ± 12.5 years, and 54.3% of the patients were women. The most common diagnoses were breast cancer (n = 23, 25.1%), lung cancer (n = 21, 22.9%), gastrointestinal cancer (n = 20, 20.9%), and lymphoma (n = 16, 17.7%). A hemoglobin response was observed in 36 (39.1%), 53 (57.6%), and 61 (66.3%) patients in the third, fifth, and eighth weeks, respectively. The mean increase in hemoglobin levels from the baseline to the end of treatment was 1.77 ± 1.30 g/dL. Baseline values of hepcidin (p = 0.008), total iron binding capacity (p = 0.014), ferritin (p = 0.048), and CRP (p = 0.044) were significantly different between the responder and nonresponder groups. Multiple logistic regression analysis for baseline anemia-related biochemical variable significantly associated with the hemoglobin response showed that only baseline hepcidin level was a significant factor for hemoglobin response (odds ratio = 0.95, 95% confidence interval 0.90-1.0, p = 0.045). Hemoglobin responders had significantly lower hepcidin levels than nonresponders (mean [±standard deviation], 13.45 [±14.71] versus 35.22 [±40.470 ng/ml]; p = 0.007). However, our analysis had some limitations such as the different patient characteristics in the studies that were included, institutional differences in the measurement of hepcidin level, and missing data on long-term safety. Therefore, our findings need further validation.
CONCLUSIONS


Intravenous ferric carboxymaltose (1,000 mg) monotherapy increases hemoglobin levels without serious adverse events in patients with cancer. Hepcidin is a useful biomarker for predicting iron requirement in cancer patients.
TRIAL REGISTRATION


Clinicaltrials.gov NCT02599012.",2020,"Secondary end points included changes in transferrin saturation and levels of soluble transferrin receptors, hepcidin, erythropoietin, interleukin-6, and C-reactive protein (CRP) at each visit.","['103 recruited patients, 92 were eligible for analysis', 'patients with cancer', 'The mean patient age was 57.3 ± 12.5 years, and 54.3% of the patients were women', 'cancer patients', 'chemotherapy-induced anemia', 'enrolled patients with solid cancers who were treated at a single institute (Samsung Medical Center, South Korea), from April 2015 to July 2017']","['Hepcidin', 'ferric carboxymaltose without erythropoiesis-stimulating agents', 'Intravenous ferric carboxymaltose', 'intravenous ferric carboxymaltose', 'intravenous iron treatment']","['CRP', 'lung cancer', 'hepcidin levels', 'gastrointestinal cancer', 'Efficacy', 'hemoglobin levels', 'total iron binding capacity', 'hemoglobin level', 'changes in transferrin saturation and levels of soluble transferrin receptors, hepcidin, erythropoietin, interleukin-6, and C-reactive protein (CRP', 'number of hemoglobin responders', 'hemoglobin response']","[{'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C2001867', 'cui_str': 'ferric carboxymaltose'}, {'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0685938', 'cui_str': 'Malignant neoplasm of gastrointestinal tract'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0700379', 'cui_str': 'Total iron binding capacity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation'}, {'cui': 'C1116139', 'cui_str': 'Transferrin receptor, soluble'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",103.0,0.0792099,"Secondary end points included changes in transferrin saturation and levels of soluble transferrin receptors, hepcidin, erythropoietin, interleukin-6, and C-reactive protein (CRP) at each visit.","[{'ForeName': 'Jun Ho', 'Initials': 'JH', 'LastName': 'Jang', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University of School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Youjin', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University of School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': ""Department of Hematology, Catholic Hematology Hospital, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.""}, {'ForeName': 'Kihyun', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University of School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Seok Jin', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University of School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Won Seog', 'Initials': 'WS', 'LastName': 'Kim', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University of School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Chul Won', 'Initials': 'CW', 'LastName': 'Jung', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University of School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jeeyun', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University of School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Se-Hoon', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University of School of Medicine, Seoul, South Korea.'}]",PLoS medicine,['10.1371/journal.pmed.1003091']
2077,32511687,Contribution of Relapse-Independent Progression vs Relapse-Associated Worsening to Overall Confirmed Disability Accumulation in Typical Relapsing Multiple Sclerosis in a Pooled Analysis of 2 Randomized Clinical Trials.,"Importance


Accumulation of disability in multiple sclerosis may occur as relapse-associated worsening (RAW) or steady progression independent of relapse activity (PIRA), with PIRA regarded as a feature of primary and secondary progressive multiple sclerosis.
Objective


To investigate the contributions of relapse-associated worsening vs relapse-independent progression to overall confirmed disability accumulation (CDA) and assess respective baseline prognostic factors and outcomes of 2 treatments.
Design, Setting, and Participants


Analyses occurred from July 2015 to February 2020 on pooled data from the intention-to-treat population of 2 identical, phase 3, multicenter, double-blind, double-dummy, parallel-group randomized clinical trials (OPERA I and II) conducted between August 2011 and April 2015. In the trials, patients with relapsing multiple sclerosis (RMS), diagnosed using the 2010 revised McDonald criteria, were randomized from 307 trial sites in 56 countries; resulting data were analyzed in the pooled data set.
Interventions


Participants were randomized 1:1 to receive 600 mg of ocrelizumab by intravenous infusion every 24 weeks or subcutaneous interferon β-1a 3 times a week at a dose of 44 μg throughout a 96-week treatment period.
Main Outcomes and Measures


Confirmed disability accumulation was defined by an increase in 1 or more of 3 measures (Expanded Disability Status Scale, timed 25-ft walk, or 9-hole peg test), confirmed after 3 or 6 months, and classified per temporal association with confirmed clinical relapses (PIRA or RAW).
Results


In the pooled OPERA I and II population (1656 of 2096 eligible participants), baseline demographics and disease characteristics were similar for patients randomized to interferon β-1a vs ocrelizumab (mean [SD] age, 37.2 [9.2] vs 37.1 [9.2] years; 552 [66.6%] vs 541 women [65.4%]). After 96 weeks, 12-week composite CDA had occurred in 223 (29.6% by Kaplan-Meier estimate) randomized to interferon β-1a and 167 (21.1%) randomized to ocrelizumab; 24-week composite CDA had occurred in 170 (22.7%) taking interferon β-1a and 129 (16.2%) taking ocrelizumab. The PIRA events were the main contributors to 12-week and 24-week composite CDA after 96 weeks in patients treated with interferon β-1a (174 of 223 [78.0%] and 137 of 170 [80.6%], respectively) and ocrelizumab (147 of 167 [88.0%] and 115 of 129 [89.1%], respectively); a minority had CDA explained by RAW events (69 of 390 [17.7%] and 52 of 299 [17.4%], respectively). Very few patients with composite CDA experienced both RAW and PIRA events (17 of 390 [4.4%] for 12-week and 15 of 299 [5.0%] for 24-week composite CDA). Ocrelizumab (vs interferon β-1a) was associated with reduced risk of composite CDA (hazard ratio [HR], 0.67) and confirmed PIRA (HR, 0.78) and RAW (HR, 0.47) events.
Conclusions and Relevance


Most disability accumulation in RMS is not associated with overt relapses. This indicates an underlying progression in this typical RMS population and challenges the current clinical distinction of relapsing and progressive forms of multiple sclerosis. Ocrelizumab was superior to interferon β-1a in preventing both RAW and PIRA.
Trial Registration


ClinicalTrials.gov Identifiers: OPERA I (NCT01247324) and OPERA II (NCT01412333).",2020,"Ocrelizumab (vs interferon β-1a) was associated with reduced risk of composite CDA (hazard ratio [HR], 0.67) and confirmed PIRA (HR, 0.78) and RAW (HR, 0.47) events.
","['patients with relapsing multiple sclerosis (RMS), diagnosed using the 2010 revised McDonald criteria']","['ocrelizumab by intravenous infusion every 24 weeks or subcutaneous interferon β-1a', 'Ocrelizumab (vs interferon β-1a', 'interferon β-1a vs ocrelizumab', 'Ocrelizumab']","['CDA explained by RAW events', 'reduced risk of composite CDA', 'baseline demographics and disease characteristics', 'RAW and PIRA events', 'confirmed PIRA (HR, 0.78) and RAW (HR, 0.47) events', 'disability accumulation', 'increase in 1 or more of 3 measures (Expanded Disability Status Scale, timed 25-ft walk, or 9-hole peg test', 'clinical relapses (PIRA or RAW']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C1882138', 'cui_str': 'ocrelizumab'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}]","[{'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332291', 'cui_str': 'Independent of'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C4517480', 'cui_str': '0.78'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",2096.0,0.167426,"Ocrelizumab (vs interferon β-1a) was associated with reduced risk of composite CDA (hazard ratio [HR], 0.67) and confirmed PIRA (HR, 0.78) and RAW (HR, 0.47) events.
","[{'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Kappos', 'Affiliation': 'University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Jerry S', 'Initials': 'JS', 'LastName': 'Wolinsky', 'Affiliation': 'McGovern Medical School, The University of Texas Health Science Center at Houston, Houston.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Giovannoni', 'Affiliation': 'Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Arnold', 'Affiliation': 'McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Bernasconi', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Model', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Koendgen', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Manfrini', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Shibeshih', 'Initials': 'S', 'LastName': 'Belachew', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Hauser', 'Affiliation': 'Weill Institute for Neurosciences, University of California, San Francisco, San Francisco.'}]",JAMA neurology,['10.1001/jamaneurol.2020.1568']
2078,32518063,Flash glucose monitoring helps achieve better glycemic control than conventional self-monitoring of blood glucose in non-insulin-treated type 2 diabetes: a randomized controlled trial.,"INTRODUCTION


The present study aimed to evaluate the effects of flash glucose monitoring (FGM) and conventional self-monitoring of blood glucose (SMBG) on glycemic control in patients with non-insulin-treated type 2 diabetes.
RESEARCH DESIGN AND METHODS


In this 24-week, multicenter, open-label, randomized (1:1), parallel-group study, patients with non-insulin-treated type 2 diabetes at five hospitals in Japan were randomly assigned to the FGM (n=49) or SMBG (n=51) groups and were provided each device for 12 weeks. The primary outcome was change in glycated hemoglobin (HbA1c) level, and was compared using analysis of covariance model that included baseline values and group as covariates.
RESULTS


Forty-eight participants in the FGM group and 45 in the SMBG group completed the study. The mean HbA1c levels were 7.83% (62.1 mmol/mol) in the FGM group and 7.84% (62.2 mmol/mol) in the SMBG group at baseline, and the values were reduced in both FGM (-0.43% (-4.7 mmol/mol), p<0.001) and SMBG groups (-0.30% (-3.3 mmol/mol), p=0.001) at 12 weeks. On the other hand, HbA1c was significantly decreased from baseline values in the FGM group, but not in the SMBG group at 24 weeks (FGM: -0.46% (-5.0 mmol/mol), p<0.001; SMBG: -0.17% (-1.8 mmol/mol), p=0.124); a significant between-group difference was also observed (difference -0.29% (-3.2 mmol/mol), p=0.022). Diabetes Treatment Satisfaction Questionnaire score was significantly improved, and the mean glucose levels, SD of glucose, mean amplitude of glycemic excursions and time in hyperglycemia were significantly decreased in the FGM group compared with the SMBG group.
CONCLUSIONS


Glycemic control was better with FGM than with SMBG after cessation of glucose monitoring in patients with non-insulin-treated type 2 diabetes.
TRIAL REGISTRATION NUMBER


UMIN000026452, jRCTs041180082.",2020,"The mean HbA1c levels were 7.83% (62.1 mmol/mol) in the FGM group and 7.84% (62.2 mmol/mol) in the SMBG group at baseline, and the values were reduced in both FGM (-0.43% (-4.7 mmol/mol), p<0.001) and SMBG groups (-0.30% (-3.3 mmol/mol), p=0.001) at 12 weeks.","['patients with non-insulin-treated type 2 diabetes', 'non-insulin-treated type 2 diabetes', 'Forty-eight participants in the FGM group and 45 in the SMBG group completed the study', 'patients with non-insulin-treated type 2 diabetes at five hospitals in Japan']","['FGM', 'Flash glucose monitoring', 'SMBG', 'flash glucose monitoring (FGM) and conventional self-monitoring of blood glucose (SMBG', 'conventional self-monitoring of blood glucose']","['glycated hemoglobin (HbA1c) level', 'Diabetes Treatment Satisfaction Questionnaire score', 'mean glucose levels, SD of glucose, mean amplitude of glycemic excursions and time in hyperglycemia', 'FGM', 'mean HbA1c levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0451116', 'cui_str': 'Diabetes treatment satisfaction questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0597915,"The mean HbA1c levels were 7.83% (62.1 mmol/mol) in the FGM group and 7.84% (62.2 mmol/mol) in the SMBG group at baseline, and the values were reduced in both FGM (-0.43% (-4.7 mmol/mol), p<0.001) and SMBG groups (-0.30% (-3.3 mmol/mol), p=0.001) at 12 weeks.","[{'ForeName': 'Eri', 'Initials': 'E', 'LastName': 'Wada', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Onoue', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan t-onoue@med.nagoya-u.ac.jp arima105@med.nagoya-u.ac.jp.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Kobayashi', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Handa', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Ayaka', 'Initials': 'A', 'LastName': 'Hayase', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Ito', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Furukawa', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Okuji', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Okada', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Iwama', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Sugiyama', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Tsunekawa', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Takagi', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Hagiwara', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Ito', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Hidetaka', 'Initials': 'H', 'LastName': 'Suga', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Ryoichi', 'Initials': 'R', 'LastName': 'Banno', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Yachiyo', 'Initials': 'Y', 'LastName': 'Kuwatsuka', 'Affiliation': 'Department of Advanced Medicine, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Department of Advanced Medicine, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Motomitsu', 'Initials': 'M', 'LastName': 'Goto', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Arima', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan t-onoue@med.nagoya-u.ac.jp arima105@med.nagoya-u.ac.jp.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2019-001115']
2079,32521284,The effect of vibration therapy on neck myofascial trigger points: A randomized controlled pilot study.,"BACKGROUND


The purpose of this study was to evaluate the effect of low-frequency self-administered vibration therapy into myofascial trigger points in the upper trapezius and levator scapulae on patients with chronic non-specific neck pain.
METHODS


Twenty-eight patients with chronic non-specific neck pain were randomly assigned into a vibration group, receiving 10 self-applied sessions of vibration therapy in the upper trapezius and levator scapulae trigger points; or a control group, receiving no intervention. Self-reported neck pain and disability (Neck Disability Index) and pressure pain threshold were assessed at baseline and after the first, fifth and 10th treatment sessions.
FINDINGS


Significant differences were found in the vibration group when compared to the control group after the treatment period: the vibration group reached lower Neck Disability Index scores (F = 4.74, P = .033, η 2  = 0.07) and greater pressure pain threshold values (F = 7.56, P = .01, η 2  = 0.10) than the control group. The vibration group reported a significant reduction in Neck Disability Index scores (χ2 = 19,35, P = .00, Kendall's W = 0.28) and an increase in pressure pain threshold (χ2 = 87,10, P = .00, Kendall's W = 0.73) between the assessment times over the course of the treatment. The mean increase in pressure pain threshold in the vibration group after the 10 sessions was 8.54 N/cm2, while the mean reduction in Neck Disability Index scores was 4.53 points.
INTERPRETATION


Vibration therapy may be an effective intervention for reducing self-reported neck pain and disability and pressure pain sensitivity in patients with chronic non-specific neck pain. This tool could be recommended for people with non-specific neck pain.",2020,"INTERPRETATION


Vibration therapy may be an effective intervention for reducing self-reported neck pain and disability and pressure pain sensitivity in patients with chronic non-specific neck pain.","['people with non-specific neck pain', 'patients with chronic non-specific neck pain', 'Twenty-eight patients with chronic non-specific neck pain']","['low-frequency self-administered vibration therapy', 'vibration group, receiving 10 self-applied sessions of vibration therapy in the upper trapezius and levator scapulae trigger points; or a control group, receiving no intervention', 'vibration therapy']","['Neck Disability Index scores', 'Self-reported neck pain and disability (Neck Disability Index) and pressure pain threshold', 'pressure pain threshold', 'neck myofascial trigger points', 'pressure pain threshold values']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C4283787', 'cui_str': '28'}]","[{'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0224368', 'cui_str': 'Structure of levator scapulae muscle'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2959538', 'cui_str': 'Neck disability index score'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",28.0,0.0224475,"INTERPRETATION


Vibration therapy may be an effective intervention for reducing self-reported neck pain and disability and pressure pain sensitivity in patients with chronic non-specific neck pain.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Dueñas', 'Affiliation': 'Department of Physical Therapy, University of Valencia, Gascó Oliag 5, 46010, Valencia, Spain. Electronic address: lirios.duenas@uv.es.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Zamora', 'Affiliation': 'European Sleep Care Institute, San Vicente 16, 46023, Valencia, Spain. Electronic address: innovation@escinstitute.com.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lluch', 'Affiliation': 'Department of Physical Therapy, University of Valencia, Gascó Oliag 5, 46010, Valencia, Spain; ""Pain in Motion"" international research group, Belgium. Electronic address: enrique.lluch@uv.es.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Artacho-Ramírez', 'Affiliation': 'Department of Engineering Projects, Universitat Politècnica de València, Camí de Vera s/n, 46022 València, Spain. Electronic address: miarra@dpi.upv.es.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Mayoral', 'Affiliation': 'Physical Therapy Unit, Hospital Provincial de Toledo, Toledo, Spain. Electronic address: orlando.mayoral@uclm.es.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Balasch', 'Affiliation': 'Departamento de Estadística e Investigación Operativa Aplicadas y Calidad, Universitat Politècnica de València, Camí de Vera s/n, 46022 València, Spain. Electronic address: sbalasch@eio.upv.es.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Balasch-Bernat', 'Affiliation': 'Department of Physical Therapy, University of Valencia, Gascó Oliag 5, 46010, Valencia, Spain. Electronic address: merce.balasch@uv.es.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105071']
2080,32521287,Evaluating the actual and perceived effectiveness of E-cigarette prevention advertisements among adolescents.,"BACKGROUND


The efficacy of e-cigarette prevention ads among adolescents has seldom been studied. We examined the impact of ads from the The Real Cost vaping prevention media campaign on what adolescents think and believe about vaping. We also sought to test whether perceived message effectiveness (PME) served as a proxy for ad impact.
METHODS


Participants were 543 U.S. adolescents ages 13-17. In an online experiment, we randomized participants to either: 1) persuasive e-cigarette prevention video ads from the Food and Drug Administration's The Real Cost campaign that was targeted to adolescents or 2) information-only e-cigarette harms control videos (control condition). Participants in each condition viewed 2 videos in a random order. After ad exposure, the survey assessed PME (message and effects perceptions), risk beliefs about vaping, attitudes toward vaping, and intentions to vape.
RESULTS


The FDA's The Real Cost ads led to higher beliefs about the harms of vaping (p < .001), more negative attitudes toward vaping (p < .001), and lower intentions to vape (p < .05) compared to the control videos. The Real Cost ads also scored higher on both message perceptions (p < .001) and effects perceptions (p < .001) compared to control videos. Effects perceptions were associated with all three outcomes (all ps < 0.001, adjusting for both types of PME and covariates), but message perceptions did not offer additional predictive value.
CONCLUSIONS


Exposure to The Real Cost vaping prevention ads gave adolescents a more negative view of vaping and lowered their intentions to vape compared to control videos. Effects perceptions may be superior to message perceptions as a proxy for e-cigarette prevention ad impact.",2020,The Real Cost ads also scored higher on both message perceptions (p < .001) and effects perceptions (p < .001) compared to control videos.,"['Participants were 543 U.S. adolescents ages 13-17', 'adolescents']","[""1) persuasive e-cigarette prevention video ads from the Food and Drug Administration's The Real Cost campaign that was targeted to adolescents or 2) information-only e-cigarette harms control videos (control condition"", 'E-cigarette prevention advertisements']","['survey assessed PME (message and effects perceptions), risk beliefs about vaping, attitudes toward vaping, and intentions to vape']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}]","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0052148', 'cui_str': 'APEL protocol'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0291011', 'cui_str': 'VAPE protocol'}]",543.0,0.0210644,The Real Cost ads also scored higher on both message perceptions (p < .001) and effects perceptions (p < .001) compared to control videos.,"[{'ForeName': 'Seth M', 'Initials': 'SM', 'LastName': 'Noar', 'Affiliation': 'Hussman School of Journalism and Media, University of North Carolina, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA; Center for Health Promotion and Disease Prevention, University of North Carolina, Chapel Hill, NC, USA. Electronic address: noar@email.unc.edu.'}, {'ForeName': 'Jacob A', 'Initials': 'JA', 'LastName': 'Rohde', 'Affiliation': 'Hussman School of Journalism and Media, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Prentice-Dunn', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kresovich', 'Affiliation': 'Hussman School of Journalism and Media, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Marissa G', 'Initials': 'MG', 'LastName': 'Hall', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA; Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA; Center for Health Promotion and Disease Prevention, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Noel T', 'Initials': 'NT', 'LastName': 'Brewer', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA; Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106473']
2081,32521299,Efficacy of buffered hypertonic seawater in different phenotypes of chronic rhinosinusitis with nasal polyps after endoscopic sinus surgery: a randomized double-blind study.,"PURPOSE


Nasal douching is commonly used as a postoperative management strategy for chronic rhinosinusitis with nasal polyps (CRSwNP). Few studies to date have compared the effectiveness of nasal douching in CRSwNP phenotypes after endoscopic sinus surgery (ESS). We evaluated the efficacy of seawater types in eosinophilic CRSwNP (ECRSwNP) and noneosinophilic CRSwNP (nonECRSwNP) after ESS.
METHODS


Patients with bilateral CRSwNP who had undergone ESS were blindly randomized to receive buffered hypertonic seawater (BHS) (n = 48) or physiological seawater (PS) (n = 45). CRSwNP patients were stratified by phenotypes (ECRSwNP and nonECRSwNP) retrospectively according to whether tissue eosinophils exceeded 10%. Follow-up evaluations were conducted at 2, 8, 16, and 24 weeks after surgery. Evaluations included the 22-item Sino-Nasal Outcome Test (SNOT-22), visual analog scale (VAS), Lund-Kennedy endoscopic score (LKES), saccharine clearance time (SCT), and adverse events.
RESULTS


All of the patients experienced significant improvements in SNOT-22 scores, VAS scores, and LKES over time. BHS resulted in better improvement of LEKS and SCT relative to PS at 8 weeks postoperatively. Mucosal edema formation was significantly reduced with less crusting among HBS recipients at 8 weeks. After stratification, only patients in the nonECRSwNP + BHS subgroup showed a significant improvement in LEKS and SCT at 8 weeks postoperatively. Side effect profiles were not significantly different among the groups.
CONCLUSIONS


BHS has a better inhibitory effect on mucosal edema and crusting during the early postoperative care period of CRSwNP. Among all of the patients, nonECRSwNP patients showed a significant improvement in LEKS and SCT at 8 weeks.",2020,"Side effect profiles were not significantly different among the groups.
","['chronic rhinosinusitis with nasal polyps after endoscopic sinus surgery', 'Patients with bilateral CRSwNP who had undergone ESS', 'chronic rhinosinusitis with nasal polyps (CRSwNP']","['buffered hypertonic seawater (BHS) (n\xa0=\xa048) or physiological seawater (PS) ', 'nonECRSwNP + BHS', 'noneosinophilic CRSwNP (nonECRSwNP', 'BHS', 'buffered hypertonic seawater']","['Mucosal edema formation', '22-item Sino-Nasal Outcome Test (SNOT-22), visual analog scale (VAS), Lund-Kennedy endoscopic score (LKES), saccharine clearance time (SCT), and adverse events', 'mucosal edema and crusting', 'LEKS and SCT relative to PS', 'LEKS and SCT', 'SNOT-22 scores, VAS scores, and LKES over time']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0036499', 'cui_str': 'Sea Water'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}]","[{'cui': 'C0521481', 'cui_str': 'Mucous membrane edema'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C5197689', 'cui_str': 'Sinonasal Outcome Test'}, {'cui': 'C5197690', 'cui_str': 'SNOT-22'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205204', 'cui_str': 'Crust'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0036499', 'cui_str': 'Sea Water'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",,0.0772097,"Side effect profiles were not significantly different among the groups.
","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Zhi-Qun', 'Initials': 'ZQ', 'LastName': 'Huang', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Luo', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Meng-Yue', 'Initials': 'MY', 'LastName': 'Li', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Jun-Hao', 'Initials': 'JH', 'LastName': 'Tu', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China. Electronic address: yjholly@email.ncu.edu.cn.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102554']
2082,32522282,Proactive Prophylaxis With Azithromycin and HydroxyChloroquine in Hospitalised Patients With COVID-19 (ProPAC-COVID): A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


The aim of this randomised GCP-controlled trial is to clarify whether combination therapy with the antibiotic azithromycin and hydroxychloroquine via anti-inflammation/immune modulation, antiviral efficacy and pre-emptive treatment of supra-infections can shorten hospitalisation duration for patients with COVID-19 (measured as ""days alive and out of hospital"" as the primary outcome), reduce the risk of non- invasive ventilation, treatment in the intensive care unit and death.
TRIAL DESIGN


This is a multi-centre, randomised, Placebo-controlled, 2-arm ratio 1:1, parallel group double-blind study.
PARTICIPANTS


226 participants are recruited at the trial sites/hospitals, where the study will take place in Denmark: Aalborg, Bispebjerg, Gentofte, Herlev, Hillerød, Hvidovre, Odense and Slagelse hospitals.
INCLUSION CRITERIA


• Patient admitted to Danish emergency departments, respiratory medicine departments or internal medicine departments • Age≥ 18 years • Hospitalized ≤48 hours • Positive COVID-19 test / diagnosis during the hospitalization (confirmed). • Men or non-fertile women. Fertile women* must not be pregnant, i.e. negative pregnancy test must be available at inclusion • Informed consent signed by the patient *Defined as after menarche and until postmenopausal (no menstruation for 12 months) Exclusion criteria: • At the time of recruitment, the patient uses >5 LO2/min (equivalent to 40% FiO2 if measured) • Known intolerance/allergy to azithromycin or hydroxychloroquine or hypersensitivity to quinine or 4-aminoquinoline derivatives • Neurogenic hearing loss • Psoriasis • Retinopathy • Maculopathy • Visual field changes • Breastfeeding • Severe liver diseases other than amoebiasis (INR> 1.5 spontaneously) • Severe gastrointestinal, neurological and hematological disorders (investigator-assessed) • eGFR <45 ml/min/1.73 m2 • Clinically significant cardiac conduction disorders/arrhythmias or prolonged QTc interval (QTc (f) of> 480/470 ms). • Myasthenia gravis • Treatment with digoxin* • Glucose-6-phosphate dehydrogenase deficiency • Porphyria • Hypoglycaemia (Blood glucose at any time since hospitalization of <3.0 mmol/L) • Severe mental illness which significantly impedes cooperation • Severe linguistic problems that significantly hinder cooperation • Treatment with ergot alkaloids *The patient must not be treated with digoxin for the duration of the intervention. For atrial fibrillation/flutter, select according to the Cardiovascular National Treatment Guide (NBV): Calcium antagonist, Beta blocker, direct current (DC) conversion or amiodarone. In case of urgent need for digoxin treatment (contraindication for the aforementioned equal alternatives), the test drug should be paused, and ECG should be taken daily.
INTERVENTION AND COMPARATOR


Control group: The control group will receive the standard treatment + placebo for both types of intervention medication at all times. If part or all the intervention therapy being investigated becomes standard treatment during the study, this may also be offered to the control group. Intervention group: The patients in the intervention group will also receive standard care. Immediately after randomisation to the intervention group, the patient will begin treatment with: Azithromycin: Day 1-3: 500 mg x 1 Day 4-15: 250 mg x 1 If the patient is unable to take the medication orally by themselves, the medication will, if possible, be administered by either stomach-feeding tube, or alternatively, temporary be changed to clarithromycin 500 mg x 2 (this only in agreement with either study coordinator Pradeesh Sivapalan or principal investigator Jens-Ulrik Stæhr Jensen). This will also be done in the control group if necessary. The patient will switch back to azithromycin when possible. Hydroxychloroquine: Furthermore, the patient will be treated with hydroxychloroquine as follows: Day 1-15: 200 mg x 2 MAIN OUTCOMES: • Number of days alive and discharged from hospital within 14 days (summarises both whether the patient is alive and discharged from hospital) (""Days alive and out of hospital"") RANDOMISATION: The sponsor (Chronic Obstructive Pulmonary Disease Trial Network, COP:TRIN) generates a randomisation sequence. Randomisation will be in blocks of unknown size and the final allocation will be via an encrypted website (REDCap). There will be stratification for age (>70 years vs. <=70 years), site of recruitment and whether the patient has any of the following chronic lung diseases: COPD, asthma, bronchiectasis, interstitial lung disease (Yes vs. No).
BLINDING (MASKING)


Participants and study personnel will both be blinded, i.e. neither will know which group the participant is allocated to.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


This study requires 226 patients randomised 1:1 with 113 in each group.
TRIAL STATUS


Protocol version 1.8, from April 16, 2020. Recruitment is ongoing (first patient recruited April 6, 2020; final patient expected to be recruited October 31, 2020).
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT04322396 (registered March 26, 2020) FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).",2020,Clinically significant cardiac conduction disorders/arrhythmias or prolonged QTc interval (QTc (f) of> 480/470 ms).,"['Men or non-fertile women', 'Neurogenic hearing loss •', 'Hospitalized ≤48 hours •', 'Psoriasis •', 'Age≥ 18 years •', '226 participants are recruited at the trial sites/hospitals, where the study will take place in Denmark: Aalborg, Bispebjerg, Gentofte, Herlev, Hillerød, Hvidovre, Odense and Slagelse hospitals', 'Hospitalised Patients With COVID-19 (ProPAC-COVID', 'Patient admitted to Danish emergency departments, respiratory medicine departments or internal medicine departments •', '226 patients randomised 1:1 with 113 in each group', 'Protocol version 1.8, from April 16, 2020', 'Myasthenia gravis •', 'Exclusion criteria']","['standard care', 'Placebo', 'Azithromycin and HydroxyChloroquine', 'azithromycin', 'hydroxychloroquine', 'Azithromycin', 'Hydroxychloroquine', 'azithromycin or hydroxychloroquine', 'ergot alkaloids', 'amiodarone', 'standard treatment + placebo', 'antibiotic azithromycin and hydroxychloroquine', 'digoxin* •', 'clarithromycin', 'digoxin']","['Porphyria • Hypoglycaemia (Blood glucose', 'Severe linguistic problems', 'Severe mental illness', 'Glucose-6-phosphate dehydrogenase deficiency •', 'Severe gastrointestinal, neurological and hematological disorders (investigator-assessed) • eGFR', 'cardiac conduction disorders/arrhythmias or prolonged QTc interval (QTc (f) of> 480/470 ms']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0033518', 'cui_str': 'PROPAC'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0587456', 'cui_str': 'Respiratory medicine department'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C4546716', 'cui_str': 'Indium-113'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia gravis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0014707', 'cui_str': 'Ergot Alkaloids'}, {'cui': 'C0002598', 'cui_str': 'Amiodarone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}]","[{'cui': 'C0032708', 'cui_str': 'Disorder of porphyrin metabolism'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0023741', 'cui_str': 'Linguistics'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C2939465', 'cui_str': 'Deficiency of glucose-6-phosphate dehydrogenase'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0018939', 'cui_str': 'Disorder of hematopoietic system'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0264886', 'cui_str': 'Conduction disorder of the heart'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0860814', 'cui_str': 'QTc'}]",226.0,0.205118,Clinically significant cardiac conduction disorders/arrhythmias or prolonged QTc interval (QTc (f) of> 480/470 ms).,"[{'ForeName': 'Pradeesh', 'Initials': 'P', 'LastName': 'Sivapalan', 'Affiliation': 'Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Charlotte Suppli', 'Initials': 'CS', 'LastName': 'Ulrik', 'Affiliation': 'Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.'}, {'ForeName': 'Rasmus Dahlin', 'Initials': 'RD', 'LastName': 'Bojesen', 'Affiliation': 'Department of Surgery, Næstved-Slagelse- Ringsted Hospitals University of Southern Denmark, Slagelse, Denmark.'}, {'ForeName': 'Therese Sophie', 'Initials': 'TS', 'LastName': 'Lapperre', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Josefin Viktoria', 'Initials': 'JV', 'LastName': 'Eklöf', 'Affiliation': 'Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Kjell Erik Julius', 'Initials': 'KEJ', 'LastName': 'Håkansson', 'Affiliation': 'Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Browatzki', 'Affiliation': 'Department of Respiratory and Infectious Diseases, Nordsjællands Hospital University of Copenhagen, Hillerød, Denmark.'}, {'ForeName': 'Casper', 'Initials': 'C', 'LastName': 'Tidemansen', 'Affiliation': 'Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.'}, {'ForeName': 'Jon Torgny', 'Initials': 'JT', 'LastName': 'Wilcke', 'Affiliation': 'Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Janner', 'Affiliation': 'Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Gottlieb', 'Affiliation': 'Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Howraman', 'Initials': 'H', 'LastName': 'Meteran', 'Affiliation': 'Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Celeste', 'Initials': 'C', 'LastName': 'Porsbjerg', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Birgitte Lindegaard', 'Initials': 'BL', 'LastName': 'Madsen', 'Affiliation': 'Department of Respiratory and Infectious Diseases, Nordsjællands Hospital University of Copenhagen, Hillerød, Denmark.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Moberg', 'Affiliation': 'Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Pedersen', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Thomas Lars', 'Initials': 'TL', 'LastName': 'Benfield', 'Affiliation': 'Dep. of Infectious Diseases, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.'}, {'ForeName': 'Jens Dilling', 'Initials': 'JD', 'LastName': 'Lundgren', 'Affiliation': 'Department of Infectious Diseases, Rigshospitalet University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Filip Krag', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Department of Clinical Metabolic Research, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Tor', 'Initials': 'T', 'LastName': 'Biering-Sørensen', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Muzhda', 'Initials': 'M', 'LastName': 'Ghanizada', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Tine Peick', 'Initials': 'TP', 'LastName': 'Sonne', 'Affiliation': 'Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Uffe Christian Steinholtz', 'Initials': 'UCS', 'LastName': 'Bødtger', 'Affiliation': 'Department of Internal Medicine, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Sidse Graff', 'Initials': 'SG', 'LastName': 'Jensen', 'Affiliation': 'Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Daniel Bech', 'Initials': 'DB', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Respiratory Medicine, Næstved-Slagelse-Ringsted Hospitals University of Southern Denmark, Slagelse, Denmark.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Brøndum', 'Affiliation': 'Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.'}, {'ForeName': 'Oliver Djurhuus', 'Initials': 'OD', 'LastName': 'Tupper', 'Affiliation': 'Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.'}, {'ForeName': 'Susanne Wiemann', 'Initials': 'SW', 'LastName': 'Sørensen', 'Affiliation': 'Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.'}, {'ForeName': 'Gitte', 'Initials': 'G', 'LastName': 'Alstrup', 'Affiliation': 'Department of Respiratory Medicine, Næstved-Slagelse-Ringsted Hospitals University of Southern Denmark, Slagelse, Denmark.'}, {'ForeName': 'Christian Borbjerg', 'Initials': 'CB', 'LastName': 'Laursen', 'Affiliation': 'Department of Respiratory Medicine, Odense University Hospital University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Ulla Weinrich', 'Initials': 'UW', 'LastName': 'Møller', 'Affiliation': 'Department of Respiratory Medicine, Aalborg University Hospital University of Aalborg, Aalborg, Denmark.'}, {'ForeName': 'Asger', 'Initials': 'A', 'LastName': 'Sverrild', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens-Ulrik Stæhr', 'Initials': 'JS', 'LastName': 'Jensen', 'Affiliation': 'Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark. jens.ulrik.jensen@regionh.dk.'}]",Trials,['10.1186/s13063-020-04409-9']
2083,32522320,"Success and Behavior During Atraumatic Restorative Treatment, the Hall Technique, and the Stainless Steel Crown Technique for Primary Molar Teeth.","Purposes:  The purposes of this prospective trial were to: (1) compare the clinical and radiographic outcomes of three restorative methods -modified atraumatic restorative treatment (mART), the Hall technique (HT), and stainless steel crown (SSC)-in primary molars with multi-surface carious lesions; and (2) assess child behavior throughout these treatments.  Methods:  In this randomized controlled trial (RCT), 123 primary molars in four- to nine-year-old children were randomly divided into treatment groups (HT, mART, and SSC). Variables, including signs of failure, treatment time, child's discomfort, child's behavior, and canine overbite relationship in HT, were recorded immediately after the treatment and at six- and 12-month recalls.  Results:  Failures occurred most significantly for mART at all recalls (P=0.001). The treatment time was significantly higher in SSC. There was no significant difference in the child-assessment of discomfort (P=0.814). The child's behavior, as evaluated by the dentist, however, was significantly better for the SSC group. Alterations to the canine overbite relationship of HT decreased significantly during recalls (P<0.001).  Conclusions:  The high success and shorter treatment time of the Hall technique support its consideration as an alternative to the conventional technique for the treatment of carious primary teeth with multisurface lesions. The results for modified atraumatic restorative treatment were not as satisfying.",2020,Alterations to the canine overbite relationship of HT decreased significantly during recalls (P<0.001).  ,"['123 primary molars in four- to nine-year-old children', 'primary molars with multi-surface carious lesions']","['restorative methods -modified atraumatic restorative treatment (mART), the Hall technique (HT), and stainless steel crown (SSC)-in']","['Success and Behavior', ""signs of failure, treatment time, child's discomfort, child's behavior, and canine overbite relationship in HT"", 'Failures', 'child-assessment of discomfort']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0038126', 'cui_str': 'Stainless steel material'}, {'cui': 'C0010384', 'cui_str': 'Crown'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C1305740', 'cui_str': 'Overbite'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",123.0,0.0299207,Alterations to the canine overbite relationship of HT decreased significantly during recalls (P<0.001).  ,"[{'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Ebrahimi', 'Affiliation': 'Dr. Ebrahimi is an associate professor of pediatric dentistry, Dental Material Research Center, Faculty of Dentistry, at the Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Alireza Sarraf', 'Initials': 'AS', 'LastName': 'Shirazi', 'Affiliation': 'Dr. Sarraf Shirazi is a full professor of pediatric dentistry, Dental Material Research Center, Faculty of Dentistry, at the Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Afshari', 'Affiliation': 'Dr. Afshari is an assistant professor of pediatric dentistry, Golestan University of Medical Sciences, Gorgan, Iran;, Email: dr.afshari@goums.ac.ir.'}]",Pediatric dentistry,[]
2084,32525517,Association of Weight-Adjusted Caffeine and β-Blocker Use With Ophthalmology Fellow Performance During Simulated Vitreoretinal Microsurgery.,"Importance


Vitreoretinal surgery can be technically challenging and is limited by physiologic characteristics of the surgeon. Factors that improve accuracy and precision of the vitreoretinal surgeon are invaluable to surgical performance.
Objectives


To establish weight-adjusted cutoffs for caffeine and β-blocker (propranolol) intake and to determine their interactions in association with the performance of novice vitreoretinal microsurgeons.
Design, Settings, and Participants


This single-blind cross-sectional study of 15 vitreoretinal surgeons who had less than 2 years of surgical experience was conducted from September 19, 2018, to September 25, 2019, at a dry-laboratory setting. Five simulations were performed daily for 2 days. On day 1, performance was assessed after sequential exposure to placebo, low-dose caffeine (2.5 mg/kg), high-dose caffeine (5.0 mg/kg), and high-dose propranolol (0.6 mg/kg). On day 2, performance was assessed after sequential exposure to placebo, low-dose propranolol (0.2 mg/kg), high-dose propranolol (0.6 mg/kg), and high-dose caffeine (5.0 mg/kg).
Interventions


Surgical simulation tasks were repeated 30 minutes after masked ingestion of placebo, caffeine, or propranolol pills during the 2 days.
Main Outcomes and Measures


An Eyesi surgical simulator was used to assess surgical performance, which included surgical score (range, 0 [worst] to 700 [best]), task completion time, intraocular trajectory, and tremor rate (range, 0 [worst] to 100 [best]). The nonparametric Friedman test followed by Dunn-Bonferroni post hoc test was applied for multiple comparisons.
Results


Of 15 vitreoretinal surgeons, 9 (60%) were male, with a mean (SD) age of 29.6 (1.4) years and mean (SD) body mass index (calculated as weight in kilograms divided by height in meters squared) of 23.15 (2.9). Compared with low-dose propranolol, low-dose caffeine was associated with a worse total surgical score (557.0 vs 617.0; difference, -53.0; 95% CI, -99.3 to -6.7; P = .009), a lower antitremor maneuver score (55.0 vs 75.0; difference, -12.0; 95% CI, -21.2 to -2.8; P = .009), longer intraocular trajectory (2298.6 vs 2080.7 mm; difference, 179.3 mm; 95% CI, 1.2-357.3 mm; P = .048), and increased task completion time (14.9 minutes vs 12.7 minutes; difference, 2.3 minutes; 95% CI, 0.8-3.8 minutes; P = .048). Postcaffeine treatment with propranolol was associated with performance improvement; however, surgical performance remained inferior compared with low-dose propranolol alone for total surgical score (570.0 vs 617.0; difference, -51.0; 95% CI, -77.6 to -24.4; P = .01), tremor-specific score (50.0 vs 75.0; difference, -16.0; 95% CI, -31.8 to -0.2; P = .03), and intraocular trajectory (2265.9 mm vs 2080.7 mm; difference, 166.8 mm; 95% CI, 64.1-269.6 mm; P = .03).
Conclusions and Relevance


The findings suggest that performance of novice vitreoretinal surgeons was worse after receiving low-dose caffeine alone but improved after receiving low-dose propranolol alone. Their performance after receiving propranolol alone was better than after the combination of propranolol and caffeine. These results may be helpful for novice vitreoretinal surgeons to improve microsurgical performance.",2020,"Postcaffeine treatment with propranolol was associated with performance improvement; however, surgical performance remained inferior compared with low-dose propranolol alone for total surgical score (570.0 vs 617.0; difference, -51.0; 95% CI, -77.6 to -24.4; P = .01), tremor-specific score (50.0 vs 75.0; difference, -16.0; 95% CI, -31.8 to -0.2; P = .03), and intraocular trajectory (2265.9 mm vs 2080.7 mm; difference, 166.8 mm; 95% CI, 64.1-269.6 mm; P = .03).
","['15 vitreoretinal surgeons, 9 (60%) were male, with a mean (SD) age of 29.6 (1.4) years and mean (SD) body mass index (calculated as weight in kilograms divided by height in meters squared) of 23.15 (2.9', '15 vitreoretinal surgeons who had less than 2 years of surgical experience was conducted from September 19, 2018, to September 25, 2019, at a dry-laboratory setting']","['placebo, low-dose propranolol', 'Postcaffeine', 'placebo, low-dose caffeine', 'propranolol and caffeine', 'caffeine', 'placebo, caffeine, or propranolol pills', 'caffeine and β-blocker (propranolol', 'propranolol']","['intraocular trajectory', 'surgical performance, which included surgical score (range, 0', 'lower antitremor maneuver score', 'total surgical score', 'task completion time', 'tremor-specific score', 'longer intraocular trajectory', 'task completion time, intraocular trajectory, and tremor rate (range, 0 [worst] to 100 [best']","[{'cui': 'C1720040', 'cui_str': 'Retinal surgeon'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C4517641', 'cui_str': '2.9'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C3217257', 'cui_str': 'Propranolol Pill'}]","[{'cui': 'C1522223', 'cui_str': 'Intraocular route'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",5.0,0.394633,"Postcaffeine treatment with propranolol was associated with performance improvement; however, surgical performance remained inferior compared with low-dose propranolol alone for total surgical score (570.0 vs 617.0; difference, -51.0; 95% CI, -77.6 to -24.4; P = .01), tremor-specific score (50.0 vs 75.0; difference, -16.0; 95% CI, -31.8 to -0.2; P = .03), and intraocular trajectory (2265.9 mm vs 2080.7 mm; difference, 166.8 mm; 95% CI, 64.1-269.6 mm; P = .03).
","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Roizenblatt', 'Affiliation': 'Department of Ophthalmology, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Vitor', 'Initials': 'V', 'LastName': 'Dias Gomes Barrios Marin', 'Affiliation': 'Department of Ophthalmology, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alex Treiger', 'Initials': 'AT', 'LastName': 'Grupenmacher', 'Affiliation': 'Department of Ophthalmology, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Muralha', 'Affiliation': 'Department of Ophthalmology, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Faber', 'Affiliation': 'Department of Neurology and Neurosurgery, Neuroengineering and Neurocognition Laboratory, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Jiramongkolchai', 'Affiliation': 'Johns Hopkins University School of Medicine, The Wilmer Eye Institute, Baltimore, Maryland.'}, {'ForeName': 'Peter Louis', 'Initials': 'PL', 'LastName': 'Gehlbach', 'Affiliation': 'Johns Hopkins University School of Medicine, The Wilmer Eye Institute, Baltimore, Maryland.'}, {'ForeName': 'Michel Eid', 'Initials': 'ME', 'LastName': 'Farah', 'Affiliation': 'Department of Ophthalmology, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rubens', 'Initials': 'R', 'LastName': 'Belfort', 'Affiliation': 'Department of Ophthalmology, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Maia', 'Affiliation': 'Department of Ophthalmology, Universidade Federal de São Paulo, São Paulo, Brazil.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.1971']
2085,31221047,"Telecare management of pain and mood symptoms: Adherence, utility, and patient satisfaction.","INTRODUCTION


Pain, depression, and anxiety are prominent symptoms that frequently co-occur, causing significant debilitation and frequent primary care visits. This paper examines the acceptability of telecare and self-management modules in managing these conditions in a randomized trial.
METHODS


The Comprehensive Management of Mood and Physical Symptoms (CAMMPS) trial compared an automated symptom management (ASM) plus self-management intervention with a comprehensive symptom management (CSM) intervention that added telecare facilitation of enhanced services. Data from the CAMMPS trial were analysed to compare the acceptability of these two interventions as indicated by utilization and patient satisfaction surveys.
RESULTS


The mean number of automated reports completed was similar between the CSM and ASM groups (14.5 vs 14.0). Responses designated with clinically relevant ""red alerts"" (i.e. patient reports warranting an expedited nurse contact) were more frequent in the CSM group (10.2 vs 8.3). The CSM and ASM groups completed a similar number of the nine self-management modules (6.3 vs 5.8). The mean helpfulness score across all modules was higher in the CSM group than in the ASM group (1.8 vs 1.5;  p  = .003). The most common feedback suggestion from the ASM group was to have more personal interaction, while participants from both groups commonly suggested technical improvements or requests for more flexible timing of calls.
DISCUSSION


Participants generally found both interventions satisfactory, with a trend in satisfaction data suggesting that patients tended to find the CSM intervention more helpful.",2019,The mean helpfulness score across all modules was higher in the CSM group than in the ASM group (1.8 vs 1.5;  p  = .003).,[],"['automated symptom management (ASM) plus self-management intervention with a comprehensive symptom management (CSM) intervention', 'CSM intervention', 'ASM']","['mean number of automated reports completed', 'mean helpfulness score']",[],"[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0507187,The mean helpfulness score across all modules was higher in the CSM group than in the ASM group (1.8 vs 1.5;  p  = .003).,"[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Bushey', 'Affiliation': 'Department of Psychiatry, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Kroenke', 'Affiliation': 'VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, IN, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Weiner', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Porter', 'Affiliation': 'VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, IN, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Evans', 'Affiliation': 'VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, IN, USA.'}, {'ForeName': 'Fitsum', 'Initials': 'F', 'LastName': 'Baye', 'Affiliation': 'Department of Biostatistics, Fairbanks School of Public Health, Indianapolis, IN, USA.'}, {'ForeName': 'Spencer', 'Initials': 'S', 'LastName': 'Lourens', 'Affiliation': 'Department of Biostatistics, Fairbanks School of Public Health, Indianapolis, IN, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Weitlauf', 'Affiliation': 'VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, IN, USA.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19856156']
2086,32530412,The Effects of Intensive Versus Routine Treatment in Patients with Acute Kidney Injury.,"BACKGROUND


In patients with acute kidney injury (AKI), specialized treatment-initiated in response to an early-warning system- may be beneficial compared with routine treatment.
METHOD


To explore effect estimators in a pilot trial (DRKS00010530), patients with AKI on regular wards of a university hospital were treated either in the usual way (control group) or more intensively (intervention group). The subjects were allotted randomly to the two treatment groups. The more intensive treatment consisted of an early warning system for a rise in the serum creatinine concentration, immediate consultation of a specialist, and the issuance of a patient kidney passport. The primary endpoint was recovery of renal function after AKI during the index hospitalization. Renal complications and process indicators were the secondary endpoints.
RESULTS


The proportion of patients whose renal function returned to baseline after AKI was 50% in the intervention group (N = 26) and 42% in the control group (N = 26) (odds ratio 1.4, 95% confidence interval [0.5; 4.0], p = 0.58). The calculated glomerular filtration rate went down, from hospital admission to discharge, by 3 mL/min/1.73 m2 (1st-3rd quartile: [6; -20]) in the intervention group and by 13 mL/min/1.73 m2 in the control group (1st-3rd quartile: [0; -25]; p = 0.09). Complications of AKI such as hyperkalemia, pulmonary edema, and renal acidosis were rarer in the intervention group (15% versus 39%; p = 0.03). In the intervention group, compared with the control group, the cause of AKI was identified more frequently (27% versus 4%; p = 0.05); drugs with relevance to the kidney were discontinued more frequently (65% versus 31%; p = 0.01); and the diagnosis of AKI was more frequently documented in the patient's chart (58% versus 37%; p = 0.03).
CONCLUSION


Specialized consultations supported by an early warning system for AKI seem to be beneficial for patients. The findings of this pilot trial should be verified in larger-scale randomized controlled trials.",2020,"The calculated glomerular filtration rate went down, from hospital admission to discharge, by 3 mL/min/1.73 m2 (1st-3rd quartile:","['patients with acute kidney injury (AKI', 'Patients with Acute Kidney Injury', 'patients with AKI on regular wards of a university hospital']",['Intensive Versus Routine Treatment'],"['cause of AKI', 'renal function', 'recovery of renal function', 'calculated glomerular filtration rate', 'diagnosis of AKI', 'Complications of AKI such as hyperkalemia, pulmonary edema, and renal acidosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0034063', 'cui_str': 'Pulmonary edema'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0001122', 'cui_str': 'Acidosis'}]",,0.061064,"The calculated glomerular filtration rate went down, from hospital admission to discharge, by 3 mL/min/1.73 m2 (1st-3rd quartile:","[{'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Haase-Fielitz', 'Affiliation': 'Department of Cardiology, Brandenburg Heart Center, Immanuel Hospital, Bernau; Brandenburg Medical School Theodor Fontane; Institute of Social Medicine and Health Systems Research, Magdeburg University, Magdeburg; Department of Nephrology and Endocrinology, Ernst von Bergmann Hospital, Potsdam; Department of Urology and Pediatric Urology, Magdeburg University Hospital, Magdeburg; Department of Orthopedics and Trauma Surgery, Ameos Hospital, Schönebeck; Institute of Laboratory Medicine, Leipzig University Hospital, Leipzig; Diaverum Renal Care Center Am Neuen Garten, Potsdam; Faculty of Medicine, Otto-von-Guericke University of Magdeburg; Department of Nephrology, Essen University Hospital, Essen.'}, {'ForeName': 'Saban', 'Initials': 'S', 'LastName': 'Elitok', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schostak', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Ernst', 'Affiliation': ''}, {'ForeName': 'Berend', 'Initials': 'B', 'LastName': 'Isermann', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Albert', 'Affiliation': ''}, {'ForeName': 'Bernt-Peter', 'Initials': 'BP', 'LastName': 'Robra', 'Affiliation': ''}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kribben', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Haase', 'Affiliation': ''}]",Deutsches Arzteblatt international,['10.3238/arztebl.2020.0289']
2087,32530436,A Mobile Game (Safe City) Designed to Promote Children's Safety Knowledge and Behaviors: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Children have high levels of curiosity and eagerness to explore. This makes them more vulnerable to danger and hazards, and they thus have a higher risk of injury. Safety education such as teaching safety rules and tips is vital to prevent children from injuries. Although game-based approaches have the potential to capture children's attention and sustain their interest in learning, whether these new instructional approaches are more effective than traditional approaches in delivering safety messages to children remains uncertain.
OBJECTIVE


The aim of this study is to test the effectiveness of a game-based intervention in promoting safety knowledge and behaviors among Hong Kong school children in Grades 4-6. It will also examine the potential effect of the game-based intervention on these children's functioning and psychosocial difficulties.
METHODS


This study comprises the development of a city-based role-playing game Safe City, where players are immersed as safety inspectors to prevent dangerous situations and promote safety behavior in a virtual city environment. The usability and acceptability tests will be conducted with children in Grades 4-6 who will trial the gameplay on a mobile phone. Adjustments will be made based on their feedback. A 4-week randomized controlled trial with children studying in Grades 4-6 in Hong Kong elementary schools will be conducted to assess the effectiveness of the Safe City game-based intervention. In this trial, 504 children will play Safe City, and 504 children will receive traditional instructional materials (electronic and printed safety information). The evaluation will be conducted using both child self-report and parent proxy-report data. Specifically, child safety knowledge and behaviors will be assessed by a questionnaire involving items on knowledge and behaviors, respectively, for home safety, road safety, and sport-related safety; child functioning will be assessed by PedsQL Generic Core Scales; and psychosocial difficulties will be assessed by the Strength and Difficulties Questionnaire. These questionnaires will be administered at 3 time points: before, 1 month, and 3 months after the intervention. Game usage statistics will also be reviewed.
RESULTS


This project was funded in September 2019. The design and development of the Safe City game are currently under way. Recruitment and data collection will begin from September 2020 and will continue up to March 1, 2021. Full analysis will be conducted after the end of the data collection period.
CONCLUSIONS


If the Safe City game is found to be an effective tool to deliver safety education, it could be used to promote safety in children in the community and upgraded to incorporate more health-related topics to support education and empowerment for the larger public.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04096196; https://clinicaltrials.gov/ct2/show/NCT04096196.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/17756.",2020,"If the Safe City game is found to be an effective tool to deliver safety education, it could be used to promote safety in children in the community and upgraded to incorporate more health-related topics to support education and empowerment for the larger public.
","['children studying in Grades 4-6 in Hong Kong elementary schools', 'children from injuries', 'Hong Kong school children in Grades 4-6', '504 children will play Safe City, and 504 children', 'children in Grades 4-6 who will trial the gameplay on a mobile phone']","['Safe City game-based intervention', 'traditional instructional materials (electronic and printed safety information', 'Mobile Game (Safe City', 'game-based intervention']","['safety knowledge and behaviors', 'usability and acceptability tests']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}]","[{'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",504.0,0.179091,"If the Safe City game is found to be an effective tool to deliver safety education, it could be used to promote safety in children in the community and upgraded to incorporate more health-related topics to support education and empowerment for the larger public.
","[{'ForeName': 'Rosa S', 'Initials': 'RS', 'LastName': 'Wong', 'Affiliation': 'Department of Paediatrics & Adolescent Medicine, The University of Hong Kong, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Keith Ts', 'Initials': 'KT', 'LastName': 'Tung', 'Affiliation': 'Department of Paediatrics & Adolescent Medicine, The University of Hong Kong, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Hiu Tung', 'Initials': 'HT', 'LastName': 'Wong', 'Affiliation': 'Department of Paediatrics & Adolescent Medicine, The University of Hong Kong, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Frederick Kw', 'Initials': 'FK', 'LastName': 'Ho', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Hing Sang', 'Initials': 'HS', 'LastName': 'Wong', 'Affiliation': 'Department of Paediatrics & Adolescent Medicine, The University of Hong Kong, Hong Kong, China (Hong Kong).'}, {'ForeName': 'King-Wa', 'Initials': 'KW', 'LastName': 'Fu', 'Affiliation': 'Journalism and Media Studies Centre, University of Hong Kong, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Ting Chuen', 'Initials': 'TC', 'LastName': 'Pong', 'Affiliation': 'Department of Computer Science & Engineering, The Hong Kong University of Science and Technology, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Ko Ling', 'Initials': 'KL', 'LastName': 'Chan', 'Affiliation': 'Department of Applied Social Sciences, The Hong Kong Polytechnic University, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Chun Bong', 'Initials': 'CB', 'LastName': 'Chow', 'Affiliation': 'Department of Paediatrics & Adolescent Medicine, The University of Hong Kong, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Ip', 'Affiliation': 'Department of Paediatrics & Adolescent Medicine, The University of Hong Kong, Hong Kong, China (Hong Kong).'}]",JMIR research protocols,['10.2196/17756']
2088,32532766,Effect of different communication strategies about stopping cancer screening on screening intention and cancer anxiety: a randomised online trial of older adults in Australia.,"OBJECTIVE


To assess different strategies for communicating to older adults about stopping cancer screening.
DESIGN


4 (recommendation statement about stopping screening)×(2; time) online survey-based randomised controlled trial.
SETTING


Australia.
PARTICIPANTS


271 English-speaking participants, aged 65-90, screened for breast/prostate cancer at least once in past decade.
INTERVENTIONS


Time 1: participants read a scenario in which their general practitioner (GP) informed them about the potential benefits and harms of cancer screening, followed by double-blinded randomisation to one of four recommendation statements to stop screening: control ('this screening test would harm you more than benefit you'), health status ('your other health issues should take priority'), life expectancy framed positively ('this test would not help you live longer') and negatively ('you may not live long enough to benefit'). Time 2: in a follow-up scenario, the GP explained why guidelines changed over time (anchoring bias intervention).
MEASURES


Primary outcomes: screening intention and cancer anxiety (10-point scale, higher=greater intention/anxiety), measured at both time points.
SECONDARY OUTCOMES


trust (in their GP, the information provided, the Australian healthcare system), decisional conflict and knowledge of the information presented.
RESULTS


271 participants' responses analysed. No main effects were found. However, screening intention was lower for the negatively framed life expectancy versus health status statement (6.0 vs 7.1, mean difference (MD)=1.1, p=0.049, 95% CI 0.0 to 2.2) in post hoc analyses. Cancer anxiety was lower for the negatively versus positively framed life expectancy statement (4.8 vs 5.8, MD=1.0, p=0.025, 95% CI 0.1 to 1.9). The anchoring bias intervention reduced screening intention (MD=0.8, p=0.044, 95% CI 0.6 to 1.0) and cancer anxiety (MD=0.3, p=0.002, 95% CI 0.1 to 0.4) across all conditions.
CONCLUSION


Older adults may reduce their screening intention without reporting increased cancer anxiety when clinicians use a more confronting strategy communicating they may not live long enough to benefit and add an explicit explanation why the recommendation has changed.
TRIAL REGISTRATION NUMBER


Australian New Zealand Clinical Trials Registry (ACTRN12618001306202; Results).",2020,"The anchoring bias intervention reduced screening intention (MD=0.8, p=0.044, 95% CI 0.6 to 1.0) and cancer anxiety (MD=0.3, p=0.002, 95% CI 0.1 to 0.4) across all conditions.
","['Australia', '271 English-speaking participants, aged 65-90, screened for breast/prostate cancer at least once in past decade', ""271 participants' responses analysed"", 'Older adults', 'older adults in Australia']","['communication strategies about stopping cancer screening', ""stop screening: control ('this screening test would harm you more than benefit you'), health status ('your other health issues should take priority'), life expectancy framed positively""]","['Australian healthcare system), decisional conflict and knowledge of the information presented', 'screening intention and cancer anxiety (10-point scale, higher=greater intention/anxiety', 'screening intention and cancer anxiety', 'screening intention', 'Cancer anxiety', 'cancer anxiety']","[{'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0205394', 'cui_str': 'Other'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439607', 'cui_str': 'Priorities'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}]","[{'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205393', 'cui_str': 'Most'}]",271.0,0.458737,"The anchoring bias intervention reduced screening intention (MD=0.8, p=0.044, 95% CI 0.6 to 1.0) and cancer anxiety (MD=0.3, p=0.002, 95% CI 0.1 to 0.4) across all conditions.
","[{'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Rachael H', 'Initials': 'RH', 'LastName': 'Dodd', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jolyn', 'Initials': 'J', 'LastName': 'Hersch', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Cvejic', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'McCaffery', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Jansen', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia jesse.jansen@sydney.edu.au.'}]",BMJ open,['10.1136/bmjopen-2019-034061']
2089,32532767,Does accreditation of general practice promote patient-reported quality of care? A natural cluster randomised experiment.,"OBJECTIVE


To investigate whether accreditation of general practice in Denmark promotes patient-reported quality of care and patient satisfaction.
DESIGN


A national cluster randomised case control study based on an online version of the Danish Patients Evaluate Practice questionnaire. Mixed effects ordered logit regression models taking account of clustering of patients in different municipalities were used in the analyses.
SETTING


General practice in Denmark.
PARTICIPANTS


A representative sample of the Danish population.
PRIMARY AND SECONDARY OUTCOME MEASURES


The primary outcome measure was patient-reported quality of care, and patient satisfaction with general practice and patient satisfaction with the general practitioner served as secondary outcome measures.
RESULTS


In total, 3609 respondents answered the survey. We found no statistically significant relationships between patient-reported quality of care and practice accreditation (2016: OR=0.89, 95% CI 0.73 to 1.07 and 2017: OR=0.85, 95% CI 0.71 to 1.02) and between patient satisfaction with the general practitioner and accreditation (2016: OR=0.93, 95% CI 0.76 to 1.13 and 2017: OR=0.86, 95% CI 0.70 to 1.04). However, there was a statistically significant negative relationship between patient satisfaction with the general practice and recent practice accreditation compared with satisfaction with practices not yet accredited (OR=0.81, 95% CI 0.67 to 0.97) but no significant relationship between patient satisfaction with the general practice and previous accreditation (OR=0.91, 95% CI 0.76 to 1.09).
CONCLUSION


Accreditation does not promote patient-reported quality of care or patient satisfaction. On the contrary, patient satisfaction with the general practice decreases when general practice is recently accredited.",2020,"We found no statistically significant relationships between patient-reported quality of care and practice accreditation (2016: OR=0.89, 95% CI 0.73 to 1.07 and 2017: OR=0.85, 95% CI 0.71 to 1.02) and between patient satisfaction with the general practitioner and accreditation (2016: OR=0.93, 95% CI 0.76 to 1.13 and 2017: OR=0.86, 95% CI 0.70 to 1.04).","['A representative sample of the Danish population', 'General practice in Denmark', '3609 respondents answered the survey']",[],"['quality of care and practice accreditation', 'patient-reported quality of care, and patient satisfaction with general practice and patient satisfaction with the general practitioner served as secondary outcome measures']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",[],"[{'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0000941', 'cui_str': 'Accreditation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}]",3609.0,0.158256,"We found no statistically significant relationships between patient-reported quality of care and practice accreditation (2016: OR=0.89, 95% CI 0.73 to 1.07 and 2017: OR=0.85, 95% CI 0.71 to 1.02) and between patient satisfaction with the general practitioner and accreditation (2016: OR=0.93, 95% CI 0.76 to 1.13 and 2017: OR=0.86, 95% CI 0.70 to 1.04).","[{'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Riisgaard', 'Affiliation': 'Department of Public Health, Research Unit for General Practice, University of Southern Denmark, Odense, Denmark hriisgaard@health.sdu.dk.'}, {'ForeName': 'Frans Boch', 'Initials': 'FB', 'LastName': 'Waldorff', 'Affiliation': 'Department of Public Health, Research Unit for General Practice, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Merethe', 'Initials': 'M', 'LastName': 'Kirstine Andersen', 'Affiliation': 'Department of Public Health, Research Unit for General Practice, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Line Bjørnskov', 'Initials': 'LB', 'LastName': 'Pedersen', 'Affiliation': 'Department of Public Health, Research Unit for General Practice, University of Southern Denmark, Odense, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-034465']
2090,32532781,Protocol for a two-cohort randomized cluster clinical trial of a motor skills intervention: The Promoting Activity and Trajectories of Health (PATH) Study.,"INTRODUCTION


Data supports that motor skills are an underlying mechanism that influence physical activity along with perceived motor and physical competence, but the relationship between motor skills and physical activity during the early years is unclear. The goal of this study, Promoting Activity and Trajectories of Health (PATH) for Children, is to examine and compare the immediate (pre-test to post-test) and sustained (3-year follow-up) effect of an intervention on motor performance, physical activity and perceived physical competence to a control condition (ie, standard practice) in preschool-age children.
METHODS AND ANALYSIS


The PATH study is a two-cohort, randomised cluster clinical trial. 300 children between the ages of  > 3.5 to 5 years of age will be randomised to the motor skill intervention (n=153) or control (n=147) condition. Each assessment involves a measure of motor skill performance; product and process, seven consecutive days of physical activity monitoring and perceived physical competence. These measures will be assessed before and after the intervention (pre-test to post-test) and then each academic year across 3 years, grades kindergarten, first grade and second grade (3-year follow-up). To assess the clustered longitudinal effect of the intervention on outcome measures, random-effects models (eg, mixed model regression, growth curve modelling and structural equation modelling) will be used. The PATH study addresses gaps in paediatric exercise science research. Findings hold the potential to help shape public health and educational policies and interventions that support healthy development and active living during the early years.
ETHICS AND DISSEMINATION


Ethical approval for this study was obtained through the Health Sciences and Behavioral Sciences Institutional Review Board, University of Michigan (HUM00133319). The PATH study is funded by the National Institutes of Health. Findings will be disseminated via print, online media, dissemination events and practitioner and/or research journals.
TRIAL REGISTRATION NUMBER


NHLBI ClinicalTrials.gov Identifier, NCT03189862. Registered 17 August 2017, https://clinicaltrials.gov/ct2/show/NCT03189862.",2020,300 children between the ages of  > 3.5 to 5 years of age will be randomised to the motor skill intervention (n=153) or control (n=147) condition.,"['Registered 17 August 2017', 'n=153) or control (n=147) condition', 'preschool-age children', '300 children between the ages of  > 3.5 to 5 years of age']","['motor skills intervention', 'motor skill intervention']","['motor performance, physical activity and perceived physical competence']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",300.0,0.0865729,300 children between the ages of  > 3.5 to 5 years of age will be randomised to the motor skill intervention (n=153) or control (n=147) condition.,"[{'ForeName': 'Leah E', 'Initials': 'LE', 'LastName': 'Robinson', 'Affiliation': 'School of Kinesiology, University of Michigan, Ann Arbor, Michigan, USA lerobin@umich.edu.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Colabianchi', 'Affiliation': 'School of Kinesiology, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Stodden', 'Affiliation': 'Department of Physical Education, University of South Carolina, Columbia, South Carolina, USA.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Ulrich', 'Affiliation': 'School of Kinesiology, University of Michigan, Ann Arbor, Michigan, USA.'}]",BMJ open,['10.1136/bmjopen-2020-037497']
2091,32532790,A 3-Arm Randomized Phase II Study of Bendamustine/Rituximab with Bortezomib Induction or Lenalidomide Continuation in Untreated Follicular Lymphoma: ECOG-ACRIN E2408.,"PURPOSE


We sought to improve upon frontline bendamustine/rituximab (BR) induction therapy followed by rituximab maintenance in untreated high-risk follicular lymphoma (FL).
PATIENTS AND METHODS


Patients were randomized to BR induction followed by 2-year rituximab maintenance (BR-R), BR with bortezomib and rituximab maintenance (BVR-R), or BR followed by lenalidomide (1 year) with rituximab maintenance (BR-LR). Dual primary objectives were complete remission (CR) rate and 1-year disease-free survival (DFS); 289 patients enrolled (NCT01216683).
RESULTS


For induction, 92%, 87%, and 86% of patients randomized to BR-R ,  BVR-R ,  or BR-LR received 6 cycles, respectively. CR rate with BR  vs.  BVR induction was 62%  vs.  75% ( P =0.04). One-year DFS rates with BR-R  vs.  BR-LR were 85%  vs.  67%, respectively ( P =0.0009). This was due to an imbalance in CR rates post-BR induction and discontinuation due to adverse events (AEs). The most common grade 3-4 AEs for BVR  vs.  BR were neutropenia and sensory neuropathy (12% vs. <1%); 83% of the latter with intravenous bortezomib. The most common grade 3-4 AEs related to LR  vs.  rituximab maintenance were neutropenia 66% vs. 21% ( P <0.0001) and febrile neutropenia 10% vs. 2% ( P =0.05). The overall treatment-related mortality was 1.4%. With 5-year median follow-up, 3-year PFS rates for BR-R, BVR-R, and BR-LR were 77%, 82%, and 76%, respectively ( P =0.36) with OS rates of 87%, 90%, and 84%, respectively ( P =0.79). For prognostication, CR rate and POD-24 were associated with survival.
CONCLUSIONS


Altogether, neither bortezomib added to BR induction nor lenalidomide added to rituximab maintenance immediately post-BR induction are recommended in untreated FL.",2020,CR rate with BR  vs.  BVR induction was 62%  vs.  75% ( P =0.04).,"['Untreated Follicular Lymphoma', 'untreated high-risk follicular lymphoma (FL', 'Patients']","['bortezomib', 'Bendamustine/Rituximab with Bortezomib', 'bendamustine/rituximab (BR) induction therapy', 'rituximab maintenance (BR-R), BR with bortezomib and rituximab maintenance (BVR-R), or BR followed by lenalidomide (1 year) with rituximab maintenance (BR-LR']","['OS rates', 'febrile neutropenia', 'CR rate and POD-24', 'overall treatment-related mortality', 'neutropenia and sensory neuropathy', 'CR rate with BR  vs.  BVR induction', '3-year PFS rates for BR-R, BVR-R, and BR-LR', 'complete remission (CR) rate and 1-year disease-free survival']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",289.0,0.0918214,CR rate with BR  vs.  BVR induction was 62%  vs.  75% ( P =0.04).,"[{'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Evens', 'Affiliation': 'Division of Blood Disorders, Rutgers Cancer Institute of New Jersey ae378@cinj.rutgers.edu.'}, {'ForeName': 'Fangxin', 'Initials': 'F', 'LastName': 'Hong', 'Affiliation': 'ECOG-ACRIN Biostatistics Center, Dana Farber Cancer Institutes.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Habermann', 'Affiliation': 'Medicine, College of Medicine, Mayo Clinic.'}, {'ForeName': 'Ranjana H', 'Initials': 'RH', 'LastName': 'Advani', 'Affiliation': 'Department of Medicine, Stanford University.'}, {'ForeName': 'Randy D', 'Initials': 'RD', 'LastName': 'Gascoyne', 'Affiliation': 'Centre for Lymphoid Cancer, British Columbia Cancer.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Witzig', 'Affiliation': 'Internal Medicine, Division of Hematology, Mayo Clinic.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Quon', 'Affiliation': 'Radiology, Stanford University School of Medicine.'}, {'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Ranheim', 'Affiliation': 'Pathology and Laboratory Medicine, University of Wisconsin School of Medicine.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Ansell', 'Affiliation': 'Division of Hematology, Mayo Clinic.'}, {'ForeName': 'Puneet Singh', 'Initials': 'PS', 'LastName': 'Cheema', 'Affiliation': ""Saint John's Hospital Health East Care System.""}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Dy', 'Affiliation': 'Decatur Memorial Hospital.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': ""O'Brien"", 'Affiliation': 'medicine, University Hospitals Seidman Cancer Center.'}, {'ForeName': 'Jane N', 'Initials': 'JN', 'LastName': 'Winter', 'Affiliation': 'Department of Medicine, Feinberg School of Medicine, Northwestern University.'}, {'ForeName': 'Terrence P', 'Initials': 'TP', 'LastName': 'Cescon', 'Affiliation': 'McGlinn Cancer Institute, Tower Health.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Chang', 'Affiliation': 'Dept of Medicine, University of Wisconsin School of Medicine and Public Health.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Kahl', 'Affiliation': 'Department of Internal Medicine, Division of Oncology, Washington University in St. Louis School of Medicine.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-1345']
2092,31812681,Effect of two different dietary fatty acid profiles and variant rs266729 in ADIPOQ on weight loss and adiponectin concentrations.,"BACKGROUND


The role of ADIPOQ gene rs266729 variants on weight loss after a dietary intervention are still unclear.
OBJECTIVE


To analyze the effects of the ADIPOQ gene rs266729 variant n weight loss, cardiovascular risk factors, and adiponectin levels after two hypocaloric diets with different dietary fatty profiles.
DESIGN


A population of 362 obese patients was enrolled in a randomized clinical trial with two diets (Diet M, monounsaturated fat-enriched diet, and Diet P, polyunsaturated-fat enriched diet). Anthropometric measurements, an assessment of nutritional intake, and biochemical tests were performed at baseline and after 12 weeks.
RESULTS


Weight loss was similar with both diets. After Diet M, only subjects with CC genotype showed significant improvements in total cholesterol (CC vs. CG±GG) (-9.0±1.1mU/L vs. -4.5±2.4mg/dL, p=0.01), LDL cholesterol (-6.0±1.1mg/dL vs. -3.0±0.9mg/dL, p=0.03), glucose (-4.7±1.1mg/dL vs. -0.6±0.5mg/dL, p=0.01), and insulin levels (-2.6±1.0mU/L vs. -0.7±0.3mU/L, p=0.02) and in HOMA-IR (-0.5±0.2 units vs. -0.2±0.4 units, p=0.03). The same improvement was reported after Diet P in all parameters, including total cholesterol (CC vs. CG±GG) (-8.0±1.2mU/L vs. -2.1±1.4mg/dL, p=0.02), LDL cholesterol (-7.3±1.2mg/dL vs. -2.1±0.8mg/dL, p=0.02), glucose (-3.2±0.1mg/dL vs. -0.2±0.5mg/dL, p=0.01), and insulin levels (-2.5±1.0mU/L vs. -1±0.6mU/L, p=0.02) and HOMA-IR (-0.5±0.1 units vs. -0.3±0.4 units, p=0.02). Only subjects with CC genotype showed significant increases in adiponectin levels after both diets: (Diet M: 10.3±2.0ng/dL vs. Diet P: 9.3±2.9ng/dL, p=0.43).
CONCLUSION


The CC genotype of ADIPOQ gene rs266729 variant is associated to increased adiponectin levels and decreases in LDL cholesterol, glucose, insulin, and HOMA-IR levels after weight loss.",2020,"After Diet M, only subjects with CC genotype showed significant improvements in total cholesterol (CC vs. CG±GG) (-9.0±1.1mU/L vs. -4.5±2.4mg/dL, p=0.01), LDL cholesterol (-6.0±1.1mg/dL vs. -3.0±0.9mg/dL, p=0.03), glucose (-4.7±1.1mg/dL vs. -0.6±0.5mg/",['A population of 362 obese patients'],"['diets (Diet M, monounsaturated fat-enriched diet, and Diet P, polyunsaturated-fat enriched diet']","['Weight loss', 'HOMA-IR', 'weight loss, cardiovascular risk factors, and adiponectin levels', 'LDL cholesterol', 'total cholesterol (CC vs. CG±GG', 'weight loss', 'LDL cholesterol, glucose, insulin, and HOMA-IR levels', 'adiponectin levels', 'weight loss and adiponectin concentrations', 'insulin levels']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}]",362.0,0.0210599,"After Diet M, only subjects with CC genotype showed significant improvements in total cholesterol (CC vs. CG±GG) (-9.0±1.1mU/L vs. -4.5±2.4mg/dL, p=0.01), LDL cholesterol (-6.0±1.1mg/dL vs. -3.0±0.9mg/dL, p=0.03), glucose (-4.7±1.1mg/dL vs. -0.6±0.5mg/","[{'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'de Luis', 'Affiliation': 'Center of Investigation of Endocrinology and Nutrition, Medicine School and Department of Endocrinology and Investigation, Hospital Clinico Universitario, University of Valladolid, Valladolid, Spain. Electronic address: dadluis@yahoo.es.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Primo', 'Affiliation': 'Center of Investigation of Endocrinology and Nutrition, Medicine School and Department of Endocrinology and Investigation, Hospital Clinico Universitario, University of Valladolid, Valladolid, Spain.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Izaola', 'Affiliation': 'Center of Investigation of Endocrinology and Nutrition, Medicine School and Department of Endocrinology and Investigation, Hospital Clinico Universitario, University of Valladolid, Valladolid, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Aller', 'Affiliation': 'Center of Investigation of Endocrinology and Nutrition, Medicine School and Department of Endocrinology and Investigation, Hospital Clinico Universitario, University of Valladolid, Valladolid, Spain.'}]","Endocrinologia, diabetes y nutricion",['10.1016/j.endinu.2019.09.004']
2093,32534175,"Three novel prevention, diagnostic, and treatment options for COVID-19 urgently necessitating controlled randomized trials.","PURPOSE


Asymptomatic or minimally symptomatic infection with COVID-19 can result in silent transmission to large numbers of individuals, resulting in expansion of the pandemic with a global increase in morbidity and mortality. New ways of screening the general population for COVID-19 are urgently needed along with novel effective prevention and treatment strategies.
HYPOTHESIS


A hypothetical three-part prevention, diagnostic, and treatment approach based on an up-to-date scientific literature review for COVID-19 is proposed. Regarding diagnosis, a validated screening questionnaire and digital app for COVID-19 could help identify individuals who are at risk of transmitting the disease, as well as those at highest risk for poor clinical outcomes. Global implementation and online tracking of vital signs and scored questionnaires that are statistically validated would help health authorities properly allocate essential health care resources to test and isolate those at highest risk for transmission and poor outcomes. Second, regarding prevention, no validated protocols except for physical distancing, hand washing, and isolation exist, and recently ivermectin has been published to have anti-viral properties against COVID-19. A randomized trial of ivermectin, and/or nutraceuticals that have been published to support immune function including glutathione, vitamin C, zinc, and immunomodulatory supplements (3,6 Beta glucan) could be beneficial in preventing transmission or lessening symptomatology but requires statistical validation. Third, concerning treatment, COVID-19 induced inflammation and ""cytokine storm syndrome"" with hemophagocytic lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS) have resulted in extreme morbidity and mortality in those with certain comorbidities, secondary to ""acute respiratory distress syndrome"" (ARDS) and multiorgan dysfunction with disseminated intravascular coagulation (DIC). Deficiency in red blood cell, serum and alveolar glutathione has been published in the medical literature for ARDS, as well as viral and bacterial pneumonias, resulting from increased levels of free radical/oxidative stress. A randomized controlled trial of blocking NF-κB and cytokine formation using glutathione precursors (N-acetyl-cysteine [NAC] and alpha lipoic acid) and PO/IV glutathione with associated anti-viral effects should be performed, along with an evaluation of Nrf2 activators (curcumin, sulforaphane glucosinolate) which have been scientifically proven to lower inflammation. Since high mortality rates from sepsis induced DIC due to COVID-19 infection has also been associated with thrombotic events and elevated levels of D-dimer, randomized controlled trials of using anticoagulant therapy with heparin is urgently required. This is especially important in patients on ventilators who have met certain sepsis induced coagulopathy (SIC) criteria. The use of acetazolamide with or without sildenafil also needs to be explored with or without heparin, since increased oxygen delivery to vital organs through prevention of thrombosis/pulmonary emboli along with carbonic anhydrase inhibition may help increase oxygenation and prevent adverse clinical outcomes.
CONCLUSION AND IMPLICATIONS


A three-part prevention, diagnostic, and treatment plan is proposed for addressing the severe complications of COVID-19. Digital monitoring of symptoms to clinically diagnose early exposure and response to treatment; prevention with ivermectin as well as nutritional therapies that support a healthy immune response; treatment with anti-inflammatory therapies that block NF-κB and activate Nrf2 pathways, as well as novel therapies that address COVID-19 pneumonia and ARDS with DIC including anticoagulation and/or novel respiratory therapies with or without acetazolamide and sildenafil. These three broad-based interventions urgently need to be subjected to randomized, controlled trials.",2020,"New ways of screening the general population for COVID-19 are urgently needed along with novel effective prevention and treatment strategies.
",['patients on ventilators who have met certain sepsis induced coagulopathy (SIC) criteria'],"['ivermectin', 'acetazolamide and sildenafil', 'heparin', 'hemophagocytic lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS', 'acetazolamide with or without sildenafil', 'blocking NF-κB and cytokine formation using glutathione precursors (N-acetyl-cysteine [NAC] and alpha lipoic acid) and PO/IV glutathione']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2603364', 'cui_str': 'On ventilator'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C0000981', 'cui_str': 'Acetazolamide'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0024291', 'cui_str': 'Hemophagocytic lymphohistiocytosis'}, {'cui': 'C1868709', 'cui_str': 'Activation syndrome'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0023791', 'cui_str': 'thioctic acid'}]",[],,0.0711722,"New ways of screening the general population for COVID-19 are urgently needed along with novel effective prevention and treatment strategies.
","[{'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Horowitz', 'Affiliation': 'HHS Babesia and Tickborne Pathogen Subcommittee, Washington, D.C. 20201, USA; Hudson Valley Healing Arts Center, 4232 Albany Post Road, Hyde Park, NY 12538, USA. Electronic address: medical@hvhac.com.'}, {'ForeName': 'Phyllis R', 'Initials': 'PR', 'LastName': 'Freeman', 'Affiliation': 'Hudson Valley Healing Arts Center, 4232 Albany Post Road, Hyde Park, NY 12538, USA.'}]",Medical hypotheses,['10.1016/j.mehy.2020.109851']
2094,32538005,[Influence of acupuncture combined with rehabilitation therapy on limb motor function and serum cAMP and cGMP in patients with hemiplegia of cerebral ischemic stroke].,"OBJECTIVE


To evaluate the therapeutic effect of the combined treatment with balance acupuncture therapy and exercise re-learning rehabilitation therapy and the impact on serum cAMP and cGMP in the patients with hemiplegia of cerebral ischemic stroke.
METHODS


A total of 90 patients of hemiplegia of cerebral ischemic stroke were randomized into an observation group and a control group, 45 cases in each one. All of the patients in the two groups received health education, diet guidance, routine symptomatic treatment as well as exercise re-learning rehabilitation therapy. Additionally, in the observation group, balance acupuncture therapy was applied, in which, the acupoints on the  yang  aspect of the human body, on the governor vessel and bladder meridian were adopted in the morning and those on the  yin  aspect of the human body, on the conception vessel and kidney meridian were stimulated in the afternoon. In the control group, the regular acupuncture was given. In the two groups, both acupuncture and rehabilitation therapies were given 5 days a week, 2 week-treatment as one course and totally 2 courses were required. Separately, before and after treatment, the score of Fugl-Meyer assessment (FMA) and the score of Chinese stroke scale (CSS) were recorded, the levels of cyclic adenosine monophosphate (cAMP) and cyclic guanosine monophosphate (cGMP) detected in serum and the clinical therapeutic effect were evaluated in the two groups.
RESULTS


After treatment, FMA score was increased in the patients of either of the groups as compared with that before treatment ( P <0.01) and CSS score decreased as compared with that before treatment ( P <0.01). After treatment, FMA score in the observation group was higher than that in the control group ( P <0.01) and CSS score was lower than the control group ( P <0.01). After treatment, the level of serum cAMP of the patients in either of the groups was increased as compared with that before treatment ( P <0.01) and that of cGMP decreased as compared with that before treatment ( P <0.01). After treatment, the level of cAMP in the observation group was higher than that in the control group ( P <0.01) and that of cGMP was lower than the control group ( P <0.01). The total effective rate was 93.3% (42/45) in the observation group, better than 73.3% (33/45) in the control group ( P <0.01).
CONCLUSION


The balance acupuncture therapy combined with exercise re-learning rehabilitation effectively improves the motor function of the affected limb, relieves injury and regulate the levels of serum cAMP and cGMP in the patients with hemiplegia of ischemic stroke.",2020,"After treatment, FMA score in the observation group was higher than that in the control group ( P <0.01) and CSS score was lower than the control group ( P <0.01).","['patients with hemiplegia of cerebral ischemic stroke', '90 patients of hemiplegia of cerebral ischemic stroke', 'patients with hemiplegia of ischemic stroke']","['health education, diet guidance, routine symptomatic treatment as well as exercise re-learning rehabilitation therapy', 'acupuncture combined with rehabilitation therapy', 'balance acupuncture therapy', 'acupuncture therapy combined with exercise re-learning rehabilitation', 'balance acupuncture therapy and exercise re-learning rehabilitation therapy']","['FMA score', 'level of cAMP', 'total effective rate', 'CSS score', 'score of Fugl-Meyer assessment (FMA) and the score of Chinese stroke scale (CSS', 'levels of cyclic adenosine monophosphate (cAMP) and cyclic guanosine monophosphate (cGMP) detected in serum and the clinical therapeutic effect', 'limb motor function and serum cAMP and cGMP', 'cGMP', 'level of serum cAMP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0265338', 'cui_str': 'Coffin-Siris syndrome'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018338', 'cui_str': 'Cyclic guanosine monophosphate'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}]",90.0,0.0241574,"After treatment, FMA score in the observation group was higher than that in the control group ( P <0.01) and CSS score was lower than the control group ( P <0.01).","[{'ForeName': 'Fu-Quan', 'Initials': 'FQ', 'LastName': 'Jing', 'Affiliation': 'Department of Acupuncture-Moxibustion and Tuina.'}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Qin', 'Affiliation': 'Department of Neurosurgery, First Affiliated Hospital of Xinjiang Medical University, Urumqi 830011, China.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Acupuncture-Moxibustion and Tuina.'}, {'ForeName': 'Zeng-Liang', 'Initials': 'ZL', 'LastName': 'Wang', 'Affiliation': 'Department of Neurosurgery, First Affiliated Hospital of Xinjiang Medical University, Urumqi 830011, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190613-k0001']
2095,32538006,[Therapeutic effect of nape cluster acupuncture combined with swallowing function training on post-stroke dysphagia].,"OBJECTIVE


To observe the effect on swallowing function in patients with post-stroke dysphagia treated with nape cluster acupuncture and the immediate effect of acupuncture at Fengchi (GB 20).
METHODS


A total of 60 patients with post-stroke dysphagia were randomized into an observation group and a control group, 30 cases in each one.On the basis of conventional western medication treatment, swallowing function training was applied in the control group, once a day.On the base of the treatment as the control group, nape cluster acupuncture was applied at Fengchi (GB 20), Tianzhu (BL 10), Wangu (GB 12), Lianquan (CV 23), Panglianquan (Extra), Jinjin (EX-HN 12) and Yuye (EX-HN 13) in the observation group, once a day. Additionally, pricking blood was applied at Jinjin (EX-HN 12) and Yuye (EX-HN 13), 2 times a week. The treatment was given 30 min each time, a week as one course and 4 courses were required. Before and after treatment, the standardized swallowing assessment (SSA) score and video fluoroscopic swallowing study (VFSS) score were compared in the two groups. The ultrasonic diagnostic device of swallowing and surface electromyography were used to observe the immediate effect on swallowing related muscles of acupuncture at Fengchi (GB 20).
RESULTS


Compared before treatment, the SSA scores were reduced after treatment in the two groups ( P <0.05), and the change of the observation group was larger than the control group ( P <0.05). Compared before treatment, the VFSS scores were increased after treatment in the two groups ( P <0.05), and the change of the observation group was larger than the control group ( P <0.05). Acupuncture at Fengchi (GB 20) immediately increased the amplitude of submental muscles and infrahyoid muscles in the observation group ( P <0.05), the geniohyoid muscle movement time was reduced and geniohyoid muscle displacement was increased ( P <0.05).
CONCLUSION


On the base of the routine treatment, nape cluster acupuncture could improve swallowing function in patients with post-stroke dysphagia. Acupuncture at Fengchi (GB 20) could immediately affect swallowing related muscles, improve muscle amplitude and reduce swallowing time.",2020,"Compared before treatment, the VFSS scores were increased after treatment in the two groups ( P <0.05), and the change of the observation group was larger than the control group ( P <0.05).","['patients with post-stroke dysphagia treated with nape cluster', 'patients with post-stroke dysphagia', '60 patients with post-stroke dysphagia']","['acupuncture', 'Acupuncture at Fengchi (GB 20', 'acupuncture at Fengchi (GB 20', 'Acupuncture', 'nape cluster acupuncture combined with swallowing function training']","['VFSS scores', 'geniohyoid muscle movement time', 'muscle amplitude and reduce swallowing time', 'swallowing function', 'geniohyoid muscle displacement', 'standardized swallowing assessment (SSA) score and video fluoroscopic swallowing study (VFSS) score', 'amplitude of submental muscles and infrahyoid muscles', 'SSA scores', 'post-stroke dysphagia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0581758', 'cui_str': 'Cervical region back structure'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0581758', 'cui_str': 'Cervical region back structure'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C3888792', 'cui_str': 'Swallow study'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0224160', 'cui_str': 'Structure of geniohyoid muscle'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0224161', 'cui_str': 'Structure of infrahyoid muscle'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}]",60.0,0.0191458,"Compared before treatment, the VFSS scores were increased after treatment in the two groups ( P <0.05), and the change of the observation group was larger than the control group ( P <0.05).","[{'ForeName': 'Jia-Xiu', 'Initials': 'JX', 'LastName': 'Gao', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Liaoning University of TCM, Shenyang 110032, China.'}, {'ForeName': 'Hong-Fei', 'Initials': 'HF', 'LastName': 'Zhou', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Liaoning University of TCM, Shenyang 110032, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190609-k0001']
2096,32538007,[Therapeutic effect of adjuvant treatment of acupuncture in a period of day from 7:00 am to 9:00 am on non-dipper essential hypertension].,"OBJECTIVE


To compare the infuences on circadian rhythm of blood pressure in the patients with non-dipper essential hypertension between the combined treatment of time acupuncture and western medication and the simple western medication.
METHODS


A total of 70 patients with non-dipper essential hypertension were randomized into an acupuncture plus western medication group (35 cases, 2 cases dropped out) and a western medication group (35 cases). In the western medication group, levamlodipine maleate tablets were taken orally, 2.5 mg each time, once daily. In the acupuncture plus western medication group, on the base of the treatment as the western medication group, acupuncture was applied specially in the period of the day from 7:00 am to 9:00 am. The acupoints included Fengchi (GB 20), Zhongwan (CV 12), Tianshu (ST 25), Hegu (LI 4), Quchi (LI 11), Zusanli (ST 36), etc. Acupuncture was given once daily, 5 treatments a week. The duration of treatment in the two groups was 4 weeks. The clinic blood pressure before and after treatment, 24 h ambulatory blood pressure and the levels of serum melatonin (MT) and 5-serotonin (5-HT) were observed in the two groups.
RESULTS


The total effective rate of anti-hypertension was 75.8% (25/33) in the acupuncture plus western medication group, better than 54.3% (19/35) in the western medication group ( P <0.05). The 24 h average systolic blood pressure, the daytime average systolic blood pressure, the daytime average diastolic pressure, and the nighttime average systolic blood pressure were all reduced after treatment in the two groups ( P <0.05). The reduction effect of the aforementioned 4 indexes in the acupuncture plus western medication group was much more obvious as compared with the western medication group ( P <0.05). After treatment, the serum level of MT was increased and 5-HT decreased in the patients of two groups ( P <0.05). The serum level of MT in the acupuncture plus western medication group was higher than that in the western medication group and the level of 5-HT was lower than the western medication group ( P <0.05).
CONCLUSION


Time acupuncture therapy in the period of the day from 7:00 am to 9:00 am, combined with western medication effectively reduce blood pressure and regulate the levels of serum MT and 5-HT so as to maintain the circadian rhythm of blood pressure in patients with non-dipper essential hypertension. The therapeutic effect of this combined treatment is superior to simple western medication.",2020,"The clinic blood pressure before and after treatment, 24 h ambulatory blood pressure and the levels of serum melatonin (MT) and 5-serotonin (5-HT) were observed in the two groups.
","['70 patients with non-dipper essential hypertension', 'patients with non-dipper essential hypertension between the combined treatment of time acupuncture and western medication and the simple western medication', 'patients with non-dipper essential hypertension']","['acupuncture', 'Acupuncture', 'acupuncture plus western medication', 'levamlodipine maleate tablets']","['blood pressure', 'clinic blood pressure', 'ambulatory blood pressure and the levels of serum melatonin (MT) and 5-serotonin (5-HT', 'total effective rate of anti-hypertension', 'serum level of MT', 'level of 5-HT', 'Fengchi (GB 20), Zhongwan (CV 12), Tianshu (ST 25), Hegu (LI 4), Quchi (LI 11), Zusanli (ST 36), etc', '5-HT', 'average systolic blood pressure, the daytime average systolic blood pressure, the daytime average diastolic pressure, and the nighttime average systolic blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0326560', 'cui_str': 'Cinclidae'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205352', 'cui_str': 'Simple'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C2717539', 'cui_str': 'levamlodipine'}, {'cui': 'C0024572', 'cui_str': 'Maleates'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C1282151', 'cui_str': 'Average systolic blood pressure'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",70.0,0.0176407,"The clinic blood pressure before and after treatment, 24 h ambulatory blood pressure and the levels of serum melatonin (MT) and 5-serotonin (5-HT) were observed in the two groups.
","[{'ForeName': 'Yan-Jun', 'Initials': 'YJ', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Affiliated Hospital of Hebei University of CM, Shijiazhuang 050011, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Sun', 'Affiliation': 'Department of Acupuncture and Moxibustion, Affiliated Hospital of Hebei University of CM, Shijiazhuang 050011, China.'}, {'ForeName': 'Yu-Tong', 'Initials': 'YT', 'LastName': 'Hu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Affiliated Hospital of Hebei University of CM, Shijiazhuang 050011, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Third Department of Cardiovascular Medicine, Shijiazhuang TCM Hospital.'}, {'ForeName': 'Wei-Hua', 'Initials': 'WH', 'LastName': 'Xue', 'Affiliation': 'Department of Acupuncture and Moxibustion, Affiliated Hospital of Hebei University of CM, Shijiazhuang 050011, China.'}, {'ForeName': 'Yan-Hong', 'Initials': 'YH', 'LastName': 'Li', 'Affiliation': 'Department of Acupuncture and Moxibustion, Affiliated Hospital of Hebei University of CM, Shijiazhuang 050011, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190509-k0006']
2097,32538008,[Prevention effect of transcutaneous electrical acupoint stimulation for chemotherapy-related myelosuppression in non-small cell lung cancer].,"OBJECTIVE


To observe the prevention effect of transcutaneous electrical acupoint stimulation (TEAS) for chemotherapy-related myelosuppression in non-small cell lung cancer.
METHODS


A total of 102 patients with non-small cell lung cancer who received initial chemotherapy were randomly divided into a conventional group, a medication group and a TEAS group, 34 cases in each one. The conventional group was treated with chemotherapy of gemcitabine combined with cisplatin and given routine care. On the basis of conventional group's treatment, the medication group was given  Diyu   Shengbai  tablets before chemotherapy, 2-3 tablets each time, 3 times a day. In the TEAS group, on the basis of conventional group's treatment, TEAS was applied at Dazhui (GV 14), Geshu (BL 17), Hegu (LI 4), Zusanli (ST 36) and Sanyinjiao (SP 6) on day 1, 2, 3, 5, 8, 14, 21 and 28 of chemotherapy. The treatment was given 30 min each time and once a day. In the three groups, the treatment for 28 days was as one course and one course of treatment was required. The changes of leukocytes, platelets, erythrocyte, hemoglobin indexes in patients of the three groups were observed one day before chemotherapy and on day 5, 8, 11, 14, 21 and 28 of chemotherapy. The comfort situation of patients was observed one day before chemotherapy and on the 5th, 11th and 21st day of chemotherapy.
RESULTS


Compared with before chemotherapy, the leukocyte counts of three groups were decreased at various time points after chemotherapy ( P <0.05). Compared with the conventional group, the leukocyte counts were higher on day 8 and 14 in the TEAS group and on day 14 in the medication group ( P <0.05). Compared with before chemotherapy, the platelet count decreased on the day 5, 8, 11 and 14 of chemotherapy in the conventional group ( P <0.05), and the platelet counts all decreased at each time point after chemotherapy in the medication group ( P <0.05). The platelet counts of the TEAS group on day 5, 8, 11 and 14 of chemotherapy were higher than those of the conventional group ( P <0.05), and the platelet counts of the TEAS group on day 5, 8, 11 and 21 of chemotherapy were higher than those of the medication group ( P <0.05). Compared with the conventional group, the comfort situation scores of the TEAS group were higher on the 5th and 11th days of chemotherapy ( P <0.05).
CONCLUSION


Transcutaneous electrical acupoint stimulation can prevent chemotherapy-induced myelosuppression (leukocyte, platelets) in patients with non-small cell lung cancer and improve patient comfort situation.",2020,"Compared with before chemotherapy, the leukocyte counts of three groups were decreased at various time points after chemotherapy ( P <0.05).","['non-small cell lung cancer', 'patients with non-small cell lung cancer', '102 patients with non-small cell lung cancer who received']","['chemotherapy of gemcitabine combined with cisplatin and given routine care', 'TEAS', 'Transcutaneous electrical acupoint stimulation', 'transcutaneous electrical acupoint stimulation', 'initial chemotherapy', 'transcutaneous electrical acupoint stimulation (TEAS']","['platelet count', 'changes of leukocytes, platelets, erythrocyte, hemoglobin indexes', 'leukocyte counts', 'platelet counts', 'comfort situation scores']","[{'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]","[{'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",102.0,0.0162421,"Compared with before chemotherapy, the leukocyte counts of three groups were decreased at various time points after chemotherapy ( P <0.05).","[{'ForeName': 'Fang-Chao', 'Initials': 'FC', 'LastName': 'Zhao', 'Affiliation': ""Affiliated Tangshan People's Hospital of North China University of Science and Technology Department of Thoracic Surgery, Tangshan 063000, Hebei Province, China.""}, {'ForeName': 'Cheng-Yuan', 'Initials': 'CY', 'LastName': 'Ye', 'Affiliation': ""Affiliated Tangshan People's Hospital of North China University of Science and Technology Department of Cancer Comprehensive Therapy, Tangshan 063000, Hebei Province, China.""}, {'ForeName': 'Wei-Jian', 'Initials': 'WJ', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics, Tangshan 063000, Hebei Province, China.'}, {'ForeName': 'Jian-Ming', 'Initials': 'JM', 'LastName': 'Liu', 'Affiliation': ""Affiliated Tangshan People's Hospital of North China University of Science and Technology Department of Thoracic Surgery, Tangshan 063000, Hebei Province, China.""}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190626-k0002']
2098,32538014,[Light and heat of moxibustion for knee osteoarthritis：a multi-center randomized controlled trial].,"OBJECTIVE


To explore the clinical therapeutic effect of light and heat of moxibustion for knee osteoarthritis (KOA).
METHODS


A total of 216 patients with KOA were randomized into a traditional moxibustion group (72 cases, 8 cases dropped off), a moxibustion light group (72 cases, 9 cases dropped off) and a moxibustion heat group (72 cases, 10 cases dropped off).The special light-heat separation moxibustion cup was applied, the patients in the traditional moxibustion group received the treatment of moxibustion, the patients in the moxibustion light group received the treatment of moxibustion light and the patients in the moxibustion heat group received the treatment of moxibustion heat. The acupoint selection of the three groups was Neixiyan (EX-LE 4), Dubi (ST 35) and Zusanli (ST 36), the treatment was given 20 min each time, 3 times a week, 4 weeks were required totally, and the follow-up surveys were made 4 and 8 weeks after treatment. The scores of Western Ontario and McMaster University osteoarthritis index (WOMAC) and visual analogue scale (VAS) were observed before treatment, after 2 and 4 weeks of treatment, 4 and 8 weeks after treatment. The therapeutic effects were evaluated according to the criterion of patient global assessment (PGA) after 4 weeks of treatment and 8 weeks after treatment.
RESULTS


Compared with before treatment, the pain scores, stiffness scores, physical function scores and total scores of WOMAC were reduced after 2, 4 weeks of treatment and 4 weeks after treatment in the three groups ( P <0.05). The pain scores, stiffness scores, physical function scores and total scores of WOMAC were reduced 8 weeks after treatment in the traditional moxibustion group and the moxibustion heat group ( P <0.05). The stiffness score, physical function score and total score of WOMAC were reduced 8 weeks after treatment in the moxibustion light group ( P <0.05). The pain score, physical function score and total score of WOMAC in the traditional moxibustion group after 4 weeks of treatment were lower than the moxibustion light group ( P <0.05). Compared with before treatment, the VAS scores were reduced after 2, 4 weeks of treatment and 4 , 8 weeks after treatment in the three groups ( P <0.05). The improvement rates in the traditional moxibustion group and the moxibustion heat group after 4 weeks of treatment and 8 weeks after treatment were superior to the moxibustion light group ( P <0.05).
CONCLUSION


The light and heat of moxibustion have therapeutic effect for KOA, and the therapeutic effect of moxibustion heat is superior to moxibustion light.",2020,"The pain scores, stiffness scores, physical function scores and total scores of WOMAC were reduced 8 weeks after treatment in the traditional moxibustion group and the moxibustion heat group ( P <0.05).","['216 patients with KOA', 'knee osteoarthritis (KOA']","['moxibustion heat group', 'traditional moxibustion', 'moxibustion light group', 'moxibustion, the patients in the moxibustion light group received the treatment of moxibustion light and the patients in the moxibustion heat group received the treatment of moxibustion heat', 'light and heat of moxibustion', 'Light and heat of moxibustion', 'special light-heat separation moxibustion cup']","['scores of Western Ontario and McMaster University osteoarthritis index (WOMAC) and visual analogue scale (VAS', 'stiffness score, physical function score and total score of WOMAC', 'pain scores, stiffness scores, physical function scores and total scores of WOMAC', 'improvement rates', 'pain score, physical function score and total score of WOMAC', 'VAS scores']","[{'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0036679', 'cui_str': 'Separation'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",216.0,0.0184345,"The pain scores, stiffness scores, physical function scores and total scores of WOMAC were reduced 8 weeks after treatment in the traditional moxibustion group and the moxibustion heat group ( P <0.05).","[{'ForeName': 'Mo', 'Initials': 'M', 'LastName': 'Liao', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Chengdu University of TCM, Chengdu 610075, Sichuan Province, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Luo', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Chengdu University of TCM, Chengdu 610075, Sichuan Province, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Ding', 'Affiliation': 'Department of Acupuncture and Moxibustion, Luohe Hospital of TCM.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Zuo', 'Affiliation': 'Fourth Department of Acupuncture and Moxibustion, Shaanxi TCM Hospital.'}, {'ForeName': 'Ling-Ling', 'Initials': 'LL', 'LastName': 'Guo', 'Affiliation': 'Department of Acupuncture and Moxibustion, Zibo Central Hospital of Shangdong Province.'}, {'ForeName': 'Chun-Yan', 'Initials': 'CY', 'LastName': 'Gou', 'Affiliation': 'Department of Acupuncture and Moxibustion, Chongqing TCM Hospital.'}, {'ForeName': 'Cai-Rong', 'Initials': 'CR', 'LastName': 'Zhang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Nanjing TCM Hospital.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Chengdu University of TCM, Chengdu 610075, Sichuan Province, China.'}, {'ForeName': 'Shu-Guang', 'Initials': 'SG', 'LastName': 'Yu', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Chengdu University of TCM, Chengdu 610075, Sichuan Province, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20200205-k0003']
2099,32538099,House Dust Mite Sublingual Immunotherapy in Children Versus Adults With Allergic Rhinitis.,"BACKGROUND


There are only a few studies in which the clinical efficacy of SLIT has been compared between children and adults. In addition, there is a lack of research on other factors, associated with the treatment, including immunological parameters and quality of life (QOL).
OBJECTIVE


To compare the effects of sublingual immunotherapy (SLIT) in adults and children on various factors: clinical efficacy, quality of life (QOL), satisfaction, immunological parameters, and adverse events.
METHODS


Subjects who were sensitized to house dust mites and treated with SLIT for at least 2 years were enrolled. Seventy patients who completed questionnaires measuring nasal symptoms and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores and underwent serologic tests for immunological parameters at initial, 1-year, and 2-year follow-up were selected and divided into two groups based on age: a child group (age 4-12 years, n = 44) and an adult group (age 19-59 years, n = 26).
RESULTS


The Total Nasal Symptom Score (TNSS) was significantly decreased after 2 years of SLIT in both the child and adult groups ( p < 0.001 , both); however, changes in TNSS from baseline did not significantly differ between the two groups ( p = 0.365 ). More patients in adult group were satisfied with SLIT than those in child group ( p = 0.050 ), and changes in RQLQ score from baseline tended to be larger in adult group ( p = 0.089 ). The levels of immunological parameters at baseline were significantly higher in the child group than in the adult group; however, changes in the levels of these parameters were not significantly different.
CONCLUSION


Although more adult patients were satisfied with SLIT, the clinical effects of SLIT on nasal symptoms were comparable between child and adult groups. Despite different immunological values at baseline between the two groups, changing patterns of immunological parameters did not differ.",2020,"The Total Nasal Symptom Score (TNSS) was significantly decreased after 2 years of SLIT in both the child and adult groups ( p < 0.001 , both); however, changes in TNSS from baseline did not significantly differ between the two groups ( p = 0.365 ).","['Children Versus Adults With Allergic Rhinitis', 'Seventy patients who completed questionnaires measuring', 'children and adults', 'and underwent serologic tests for immunological parameters at initial, 1-year, and 2-year follow-up were selected and divided into two groups based on age: a child group (age 4-12\u2009years, n\u2009=\u200944) and an adult group (age 19-59\u2009years, n\u2009=\u200926', 'Subjects who were sensitized to house dust mites and treated with SLIT for at least 2\u2009years were enrolled', 'adults and children on various factors']","['sublingual immunotherapy (SLIT', 'SLIT', 'House Dust Mite Sublingual Immunotherapy']","['RQLQ score', 'nasal symptoms', 'nasal symptoms and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores', 'Total Nasal Symptom Score (TNSS', 'immunological parameters and quality of life (QOL', 'efficacy, quality of life (QOL), satisfaction, immunological parameters, and adverse events', 'levels of immunological parameters', 'changes in TNSS']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036743', 'cui_str': 'Serologic test'}, {'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0998367', 'cui_str': 'House dust mite'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3658366', 'cui_str': 'Sublingual Immunotherapy'}]","[{'cui': 'C3658366', 'cui_str': 'Sublingual Immunotherapy'}, {'cui': 'C0998367', 'cui_str': 'House dust mite'}]","[{'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",70.0,0.0197187,"The Total Nasal Symptom Score (TNSS) was significantly decreased after 2 years of SLIT in both the child and adult groups ( p < 0.001 , both); however, changes in TNSS from baseline did not significantly differ between the two groups ( p = 0.365 ).","[{'ForeName': 'Jin Youp', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Otorhinolaryngology, Armed Forces Capital Hospital, Seongnam, Korea.'}, {'ForeName': 'Chae-Seo', 'Initials': 'CS', 'LastName': 'Rhee', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Seong H', 'Initials': 'SH', 'LastName': 'Cho', 'Affiliation': 'Division of Allergy and Immunology, Department of Internal Medicine, Morsani College of Medicine, University of South Florida, Tampa, Florida.'}, {'ForeName': 'Goun', 'Initials': 'G', 'LastName': 'Choe', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Dong-Young', 'Initials': 'DY', 'LastName': 'Kim', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Doo Hee', 'Initials': 'DH', 'LastName': 'Han', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Seoul National University College of Medicine, Seoul, Korea.'}]",American journal of rhinology & allergy,['10.1177/1945892420931713']
2100,32538106,Randomised controlled study to compare radiofrequency ablation with minimally invasive ultrasound-guided non-flush ligation and stripping of great saphenous vein in the treatment of varicose veins.,"INTRODUCTION


Flush ligation at the saphenofemoral junction and stripping of the great saphenous vein is being increasingly replaced by endovenous methods such as radiofrequency or endovenous laser ablation for the treatment of varicose veins. These modalities are expensive and not widely available. A minimally invasive ultrasound-guided surgery with non-flush ligation and stripping under local anaesthesia is a cost-effective alternative with similar postoperative outcomes.
MATERIALS AND METHODS


A total of 62 limbs (58 patients) with saphenofemoral junction incompetence underwent clinical evaluation including the CEAP clinical score, the venous clinical severity score, the venous disability score and venous doppler. Patients were randomly assigned to either group A (radiofrequency ablation) or group B (ultrasound-guided non-flush ligation and stripping of the great saphenous vein) for procedures under tumescent anaesthesia and ultrasound guidance. Patients were followed-up on days 7, 30 and 90 to assess primary (obliteration rates) and secondary (venous clinical severity score and venous disability score) outcomes.
RESULTS


Both the groups showed 100% obliteration of the great saphenous vein at day 90. The venous clinical severity and venous disability scores significantly improved from day 0 to day 90 in both the groups ( p  = 0.0001). There were no major complications. Group A showed significantly lower minor complications ( p  = 0.001). None required conversation to general anaesthesia.
CONCLUSIONS


The ultrasound-guided non-flush ligation and stripping of the great saphenous vein are as efficacious as radio frequency ablation, with similar obliteration rates, improvement in disability scores and complication profile at a lower cost. It has the potential for wider availability in the community as most surgeons are conversant with the surgical procedure.",2020,Group A showed significantly lower minor complications ( p  = 0.001).,"['A total of 62 limbs (58 patients) with saphenofemoral junction incompetence underwent clinical evaluation including the', 'varicose veins']","['radiofrequency or endovenous laser ablation', 'ultrasound-guided non-flush ligation and stripping of the great saphenous vein', 'group A (radiofrequency ablation) or group B (ultrasound-guided non-flush ligation and stripping of the great saphenous vein) for procedures under tumescent anaesthesia and ultrasound guidance', 'radiofrequency ablation with minimally invasive ultrasound-guided non-flush ligation and stripping of great saphenous vein', 'minimally invasive ultrasound-guided surgery with non-flush ligation and stripping under local anaesthesia']","['venous clinical severity and venous disability scores', 'CEAP clinical score, the venous clinical severity score, the venous disability score and venous doppler', 'disability scores and complication profile', 'primary (obliteration rates) and secondary (venous clinical severity score and venous disability score) outcomes', 'minor complications']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0447132', 'cui_str': 'Structure of saphenofemoral junction'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042345', 'cui_str': 'Phlebectasia'}]","[{'cui': 'C0348007', 'cui_str': 'Laser Ablation'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0005874', 'cui_str': 'Blushing'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0392907', 'cui_str': 'Great saphenous vein structure'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}]","[{'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C3888865', 'cui_str': 'Venous Doppler'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332465', 'cui_str': 'Obliteration'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026193', 'cui_str': 'Minor'}]",,0.0311134,Group A showed significantly lower minor complications ( p  = 0.001).,"[{'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Sandhya', 'Affiliation': 'Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.'}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Mohil', 'Affiliation': 'Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Sricharan', 'Affiliation': 'RajaRajeswari Medical College and Hospital, Bangalore, India.'}]",Annals of the Royal College of Surgeons of England,['10.1308/rcsann.2020.0116']
2101,32538123,An integrated sleep and anxiety intervention for anxious children: A pilot randomized controlled trial.,"Sleep-related complaints hold complex reciprocal relationships with anxiety and are a pervasive, distressing feature of childhood generalized anxiety disorders (GAD). Although evidence suggests purely anxiety-focused treatments reduce some sleep problems of anxious children, interventions that directly target both anxiety and sleep might produce superior outcomes in both domains. Targeted Behavioral Therapy (TBT), developed for co-morbid sleep and anxiety problems, demonstrated initial efficacy in a small case series but has not been directly compared to anxiety-focused treatment. The current pilot study used a randomized controlled design to compare TBT to ""gold standard"" cognitive-behavioral therapy (CBT) for anxiety among  n  = 20 children (ages 6-12) with primary GAD. Multi-informant measures of anxiety and sleep (including actigraphy) were obtained at baseline, post-treatment, and 6-month follow-up. Results indicated significant improvements (based on moderate to large effect sizes) in anxiety and subjective sleep in both treatment groups at post-treatment. Improvements were maintained at 6-month follow-up. Objective sleep onset latency also decreased marginally for both groups at post-treatment (based on small effect size). Findings provide preliminary support for the feasibility and potential utility of anxiety-focused interventions for improving some sleep-related problems among anxious youth. Future studies including large samples are needed.",2020,Results indicated significant improvements (based on moderate to large effect sizes) in anxiety and subjective sleep in both treatment groups at post-treatment.,"['anxiety among  n \u2009=\u200920 children (ages 6-12) with primary GAD', 'anxious children', 'anxious youth']","['Targeted Behavioral Therapy (TBT', 'integrated sleep and anxiety intervention', 'TBT to ""gold standard"" cognitive-behavioral therapy (CBT']","['anxiety and subjective sleep', 'anxiety and sleep (including actigraphy', 'Objective sleep onset latency']","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}]",20.0,0.0336579,Results indicated significant improvements (based on moderate to large effect sizes) in anxiety and subjective sleep in both treatment groups at post-treatment.,"[{'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Clementi', 'Affiliation': 'Department of Psychiatry, University of Colorado School of Medicine, USA.'}, {'ForeName': 'Candice A', 'Initials': 'CA', 'LastName': 'Alfano', 'Affiliation': 'Department of Psychology, University of Houston, USA.'}]",Clinical child psychology and psychiatry,['10.1177/1359104520933936']
2102,32538182,Vitamin D levels in IBD: a randomised trial of weight-based versus fixed dose vitamin D supplementation.,"Objectives:  Body weight is one of the factors affecting blood levels of 25-hydroxyvitamin D (25OHD). The aim of this study was to establish whether a vitamin D (vitD) weight-based dosing is more appropriate to a fixed daily dose in patients with inflammatory bowel disease (IBD). Materials/methods:  This was an open label randomised trial. Patients with IBD were assigned to receive oral cholecalciferol at a dose of 28 IU/kg (IU/kg) or 2000 IU per day (IU/day) for 12 weeks during winter months. 25OHD plasma levels and other biochemical parameters were measured at baseline and after supplementation period. The primary outcome measure was 25OHD level after a follow-up period. Results:  A total of 173 patients were analysed. The mean BMI was 25.5 ± 5.1 and initial mean 25OHD level was 62.7 ± 25.5 nmol/l. A similar increase (9.7 ± 26.9 vs 9.8 ± 26.7 nmol/l) in 25OHD levels occurred both in IU/kg and IU/day group. The proportion of subjects with normal and sub-normal levels following the substitution was comparable irrespective of body weight. The change in 25OHD level correlated positively only with the dose of vitD ( p  < .001) and negatively with the baseline 25OHD level ( p  < .001). A sustained 25OHD level of 75 nmol/l corresponds with a calculated daily vitD dose of 2034 IU. Conclusions:  Weight-based dosing of vitamin D is not superior to a fixed dose in order to maintain stable 25OHD levels in IBD patients. Cholecalciferol dose of 2,000 IU/day is safe and sufficient during winter period.",2020,The change in 25OHD level correlated positively only with the dose of vitD ( p  < .001) and negatively with the baseline 25OHD level ( p  < .001).,"['IBD', 'A total of 173 patients were analysed', 'IBD patients', 'patients with inflammatory bowel disease (IBD', 'Patients with IBD']","['weight-based versus fixed dose vitamin D supplementation', 'Cholecalciferol', 'vitamin D (vitD) weight-based dosing', 'vitamin D', 'oral cholecalciferol']","['change in 25OHD level', '25OHD levels', '25OHD plasma levels', 'baseline 25OHD level', 'blood levels of 25-hydroxyvitamin D (25OHD', 'mean BMI', 'initial mean 25OHD level', '25OHD level', 'Vitamin D levels']","[{'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]",173.0,0.398191,The change in 25OHD level correlated positively only with the dose of vitD ( p  < .001) and negatively with the baseline 25OHD level ( p  < .001).,"[{'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Kojecky', 'Affiliation': 'Faculty of Medicine, Masaryk University Brno, Brno, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Matous', 'Affiliation': '2nd Department of Internal Medicine, Third Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Bohuslav', 'Initials': 'B', 'LastName': 'Kianicka', 'Affiliation': '2nd Department of Internal Medicine/Department of Gastroenterology, St. Anne´s University Hospital, Brno, Czech Republic.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Dite', 'Affiliation': 'Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic.'}, {'ForeName': 'Zdena', 'Initials': 'Z', 'LastName': 'Zadorova', 'Affiliation': '2nd Department of Internal Medicine, Third Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Kubovy', 'Affiliation': 'Department of Gastroenterology, Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Hlostova', 'Affiliation': 'Institute of Health Information and Statistics of the Czech Republic, Prague, Czech Republic.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Uher', 'Affiliation': 'Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Brno, Czech Republic.'}]",Scandinavian journal of gastroenterology,['10.1080/00365521.2020.1774921']
2103,32538212,"Same-day, cross-day, and upward spiral relations between positive affect and positive health behaviours.","Objective:  This project investigated same-day and lagged (i.e., from one day to the next) associations between daily positive affect and three distinct positive health behaviours: physical activity, fruit and vegetable intake, and meditation. Cross-day analyses also examined the role of positive affect felt during the targeted health behaviours. Design:  Secondary data analyses used a 9-week daily diary study in which midlife adults ( N  = 217) were randomized to learn one of two contemplative practices (i.e., mindfulness meditation or loving-kindness meditation) while reporting nightly on their emotions and health behaviours. Results:  Results of same-day analyses revealed positive associations, both between-person and within-person, for the three positive health behaviours with daily positive affect. Results of lagged analyses revealed that positive affect experienced during fruit and vegetable intake on a given day predicted next-day fruit and vegetable intake, and that fruit and vegetable intake on a given day predicted next-day positive affect. Conclusion:  The observed same-day relations between daily positive affect and engagement in positive health behaviours illuminate one path through which positive affect may contribute to health. The observed cross-day relations reveal a need for interdisciplinary research on mechanisms through which fruit and vegetable intake may shape next-day positive affect.",2020,"Results of lagged analyses revealed that positive affect experienced during fruit and vegetable intake on a given day predicted next-day fruit and vegetable intake, and that fruit and vegetable intake on a given day predicted next-day positive affect.",['midlife adults ( N \u2009=\u2009217'],['mindfulness meditation or loving-kindness meditation) while reporting nightly on their emotions and health behaviours'],[],"[{'cui': 'C0026062', 'cui_str': 'Middle-age'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517646', 'cui_str': '217'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0024028', 'cui_str': 'Love'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",[],217.0,0.0610229,"Results of lagged analyses revealed that positive affect experienced during fruit and vegetable intake on a given day predicted next-day fruit and vegetable intake, and that fruit and vegetable intake on a given day predicted next-day positive affect.","[{'ForeName': 'Barbara L', 'Initials': 'BL', 'LastName': 'Fredrickson', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Arizmendi', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Patty', 'Initials': 'P', 'LastName': 'Van Cappellen', 'Affiliation': 'Social Science Research Institute, Duke University, Durham, NC, USA.'}]",Psychology & health,['10.1080/08870446.2020.1778696']
2104,32538252,"Acute effects of MDMA on trust, cooperative behaviour and empathy: A double-blind, placebo-controlled experiment.","BACKGROUND


3,4-Methylenedioxymethamphetamine (MDMA) is being actively researched as an adjunct to psychotherapy. It may be beneficial to trust, empathy and cooperative behaviour due to its acute prosocial effects.
AIM


To test (a) the acute effects of MDMA on measures of empathy, trust and cooperative behaviour, and (b) subacute changes in mood three days after MDMA administration.
METHODS


Twenty-five participants ( n =7 female), participated in this double-blind, repeated-measures, placebo-controlled experiment. Participants attended two acute sessions, one week apart. Each acute session was followed by a subacute session three days later. Participants received placebo (100 mg ascorbic acid) during one acute session, and MDMA (100 mg MDMA-HCl) at the other, with order counterbalanced. Participants completed the following tasks assessing prosocial behaviour: a trust investment task, a trustworthy face rating task, an empathic stories task, a public project game, a dictator game and an ultimatum game. Participants reported subjective effects. Blood was taken pre-drug, 2 and 4 hours post-drug, and tested for plasma MDMA levels.
RESULTS


MDMA acutely increased self-reported 'closeness to others' and 'euphoria' and increased plasma concentrations of MDMA. MDMA did not significantly change task-based empathy, trust or cooperative behaviour. Using Bayesian analyses, we found evidence that MDMA and placebo did not differ in their effects on empathy and cooperative behaviour. MDMA did not significantly change subacute mood and this was supported by our Bayesian analyses.
CONCLUSION


Despite augmentation in plasma MDMA levels and subjective drug effects, we found no increase in prosocial behaviour in a laboratory setting.",2020,"Using Bayesian analyses, we found evidence that MDMA and placebo did not differ in their effects on empathy and cooperative behaviour.",['Twenty-five participants ( n =7 female'],"['MDMA and placebo', 'MDMA (100\u2009mg MDMA-HCl', 'tasks assessing prosocial behaviour: a trust investment task, a trustworthy face rating task, an empathic stories task, a public project game, a dictator game and an ultimatum game', 'placebo (100\u2009mg ascorbic acid', 'MDMA', '3,4-Methylenedioxymethamphetamine', 'placebo']","['empathy, trust and cooperative behaviour, and (b) subacute changes', 'subjective effects', 'plasma MDMA levels and subjective drug effects', 'prosocial behaviour', 'trust, cooperative behaviour and empathy', 'change task-based empathy, trust or cooperative behaviour', 'empathy and cooperative behaviour', 'plasma concentrations of MDMA']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0115471', 'cui_str': 'Methylenedioxymethamphetamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0023443', 'cui_str': 'Hairy cell leukemia'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0021953', 'cui_str': 'Investments'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}]","[{'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0115471', 'cui_str': 'Methylenedioxymethamphetamine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0728866', 'cui_str': 'drug effects'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",25.0,0.354268,"Using Bayesian analyses, we found evidence that MDMA and placebo did not differ in their effects on empathy and cooperative behaviour.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Borissova', 'Affiliation': 'Clinical Psychopharmacology Unit, UCL, London, UK.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Ferguson', 'Affiliation': 'UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Wall', 'Affiliation': 'Clinical Psychopharmacology Unit, UCL, London, UK.'}, {'ForeName': 'Celia Ja', 'Initials': 'CJ', 'LastName': 'Morgan', 'Affiliation': 'Psychopharmacology and Addiction Research Centre, University of Exeter, Exeter, UK.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Carhart-Harris', 'Affiliation': 'Neuropsychopharmacology Unit, Centre for Psychiatry, Imperial College London, London, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Bolstridge', 'Affiliation': 'Neuropsychopharmacology Unit, Centre for Psychiatry, Imperial College London, London, UK.'}, {'ForeName': 'Michael Ap', 'Initials': 'MA', 'LastName': 'Bloomfield', 'Affiliation': 'Clinical Psychopharmacology Unit, UCL, London, UK.'}, {'ForeName': 'Tim M', 'Initials': 'TM', 'LastName': 'Williams', 'Affiliation': 'Neuropsychopharmacology Unit, Centre for Psychiatry, Imperial College London, London, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Feilding', 'Affiliation': 'Beckley Foundation, Oxford, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Murphy', 'Affiliation': 'Cardiff University Brain Research Imaging Centre, Cardiff, UK.'}, {'ForeName': 'Robin J', 'Initials': 'RJ', 'LastName': 'Tyacke', 'Affiliation': 'Neuropsychopharmacology Unit, Centre for Psychiatry, Imperial College London, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Erritzoe', 'Affiliation': 'Neuropsychopharmacology Unit, Centre for Psychiatry, Imperial College London, London, UK.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Stewart', 'Affiliation': 'Clinical Psychopharmacology Unit, UCL, London, UK.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Wolff', 'Affiliation': ""School of Biomedical Sciences, King's College London, London, UK.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Nutt', 'Affiliation': 'Neuropsychopharmacology Unit, Centre for Psychiatry, Imperial College London, London, UK.'}, {'ForeName': 'H Valerie', 'Initials': 'HV', 'LastName': 'Curran', 'Affiliation': 'Clinical Psychopharmacology Unit, UCL, London, UK.'}, {'ForeName': 'Will', 'Initials': 'W', 'LastName': 'Lawn', 'Affiliation': 'Clinical Psychopharmacology Unit, UCL, London, UK.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120926673']
2105,32538274,"Re: Selles et al. Arthroscopic debridement does not enhance surgical treatment of intra-articular distal radius fractures: a randomized controlled trial. J Hand Surg Eur. 2020, 45: 327-32.",,2020,,"['2020, 45: 327-32', 'intra-articular distal radius fractures']",['Arthroscopic debridement'],[],"[{'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0011079', 'cui_str': 'Debridement'}]",[],,0.0375498,,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jann', 'Affiliation': 'Spital STS AG Thun, Switzerland.'}]","The Journal of hand surgery, European volume",['10.1177/1753193420922699']
2106,32538267,Naltrexone during pain conditioning: A double-blind placebo-controlled experimental trial.,"Naltrexone reversibly blocks the effects of opioids and has been shown to decrease placebo analgesia. However, it is not clear (1) to what extent naltrexone affects pain modulation in a nontreatment context, for example, in response to pain cues or (2) how naltrexone given prior to pain-cue learning shapes pain responses. In a double-blind procedure prior to pain-cue conditioning, 30 healthy participants were randomized to receive an oral dose of naltrexone (50 mg) or inert pill. During functional magnetic resonance imaging, high and low pain pressures were paired with two different visual cues: a high pain cue and a low pain cue (learning sequence). During a test sequence, medium levels of pressure were used for both cues and the difference in subjective pain ratings following high and low pain cues was calculated. Results showed significant conditioned pain responses across groups ( P  <   .001); however, no significant difference between participants receiving naltrexone or inert pill ( P  =   .193). There was a significant correlation between the difference in high and low pain ratings during the learning sequence and the effect of high and low pain cues during the test sequence (r = .575,  P  =   .002). Functional magnetic resonance imaging analyses revealed no significant difference in brain activation between groups. Here, we demonstrate comparable learning of pain responses in participants treated with naltrexone or inert pill. The results point to the possibility that associative learning, and conditional responding to pain cues, is not dependent on endogenous opioids. Our results, using pain-cue conditioning to create reduced pain responses, contrast previous studies where opioid antagonists significantly reduced the placebo effect in treatment of pain.",2020,"Results showed significant conditioned pain responses across groups ( P  <   .001); however, no significant difference between participants receiving naltrexone or inert pill ( P  =   .193).","['participants treated with', '30 healthy participants']","['naltrexone', 'naltrexone (50\u2009mg) or inert pill', 'naltrexone or inert pill', 'Naltrexone', 'placebo']","['pain modulation', 'conditioned pain responses', 'brain activation', 'high and low pain ratings', 'effect of high and low pain cues', 'subjective pain ratings', 'pain responses']","[{'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",30.0,0.262936,"Results showed significant conditioned pain responses across groups ( P  <   .001); however, no significant difference between participants receiving naltrexone or inert pill ( P  =   .193).","[{'ForeName': 'Moa', 'Initials': 'M', 'LastName': 'Pontén', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Fust', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Kosek', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Joar', 'Initials': 'J', 'LastName': 'Guterstam', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Jensen', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}]",Molecular pain,['10.1177/1744806920927625']
2107,32538286,Effects of Wearing a Full Body Compression Garment During Recovery from an Ultra-Trail Race.,"In sport disciplines with high levels of muscle damage such as an ultra-trail competition, full body compression garments (FBCG) may have an ergogenic effect during the recovery process. The aim of the study was to assess the influence of FBCG worn for 24 h immediately after a 107-km ultra-trail on delayed onset muscle soreness (DOMS), muscle damage, inflammatory and renal response. Thirty-two athletes (19 males and 13 females; VO 2peak : 54.1 ± 5.2 ml O2/kg/min) participated in the study. The following blood markers were analyzed before, immediately after, at 24 h and 48 h post-race: lactate dehydrogenase, creatine kinase, C-reactive protein and creatinine. The glomerular filtration rate was also calculated. Delayed onset muscle soreness was evaluated before, immediately after and at 24 h post-race. On arrival at the finishing line, athletes were randomized into one of two recovery groups (FBCG and control group). The results showed that wearing FBCG did not influence the evolution of any of the blood markers up to 48 h after the race (p>0.05). However, FBCG group presented a lower increase in posterior leg DOMS (11.0 ± 46.2% vs 112.3 ± 170.4%, p=0.03, d=0.8). Therefore, although FBCG is not useful for reducing muscle damage and inflammatory response after an ultra-trail race, its use may still be recommended as a recovery method to reduce muscle soreness.  Trial registration:  ClinicalTrials.gov identifier: NCT03990259..",2020,The results showed that wearing FBCG did not influence the evolution of any of the blood markers up to 48 h after the race (p>0.05).,['Thirty-two athletes (19 males and 13 females; VO 2peak : 54.1 ± 5.2 ml O2/kg/min) participated in the study'],"['FBCG', 'Wearing a Full Body Compression Garment']","['glomerular filtration rate', 'delayed onset muscle soreness (DOMS), muscle damage, inflammatory and renal response', 'posterior leg DOMS', 'Delayed onset muscle soreness']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517790', 'cui_str': '5.2'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C2985539', 'cui_str': 'Compression garment'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",,0.0531844,The results showed that wearing FBCG did not influence the evolution of any of the blood markers up to 48 h after the race (p>0.05).,"[{'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Martínez-Navarro', 'Affiliation': 'Physical Education and Sports Department, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Inma', 'Initials': 'I', 'LastName': 'Aparicio', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Physical Education and Sports Department, University of Valencia, Valencia.'}, {'ForeName': 'Jose Ignacio', 'Initials': 'JI', 'LastName': 'Priego Quesada', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Physical Education and Sports Department, University of Valencia, Valencia.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Pérez-Soriano', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Physical Education and Sports Department, University of Valencia, Valencia.'}, {'ForeName': 'Eladio', 'Initials': 'E', 'LastName': 'Collado', 'Affiliation': 'Faculty of Health Sciences, Jaume I University, Castellon, Spain.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Hernando', 'Affiliation': 'Department of Medicine, Jaume I University, Castellon, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Hernando', 'Affiliation': 'Sport Service, Jaume I University, Castellon, Spain.'}]",European journal of sport science,['10.1080/17461391.2020.1783369']
2108,32538455,"Validity, reliability and use of a Kuwait child nutrition knowledge assessment questionnaire.","Background


Little is known about the nutritional knowledge of children in Kuwait and school-based nutrition interventions are scarce. No validated tool to assess the nutrition knowledge of schoolchildren in Kuwait is available.
Aims


This study determined the validity and reliability of a nutrition knowledge questionnaire in Kuwaiti primary-school children, and measured children's nutrition knowledge before and after a nutrition awareness intervention.
Methods


The questionnaire included five questions to measure nutritional knowledge. The face and content validity were assessed by nutrition and paediatric experts. To assess questionnaire reliability and nutrition knowledge, 642 schoolchildren (8-12 years) were assigned to an intervention, control or reliability group. Each group completed the questionnaire twice, one or two weeks apart. Students in the intervention group attended a nutrition knowledge presentation before completing the questionnaire the second time. Independent and paired samples t-tests were used to assess score differences between and within the intervention and control groups for changes in nutrition knowledge. Pearson correlation coefficients were used to measure score consistency in the reliability group.
Results


Overall, the questionnaire had good content validity and moderate to strong reliability (r = 0.44, P < 0.001). Students in the intervention group had significantly higher mean nutritional knowledge scores after the intervention (from 3.65 (SD 1.03) to 4.20 (SD 1.02); P = 0.17). Control group scores were mostly unchanged.
Conclusions


The Kuwait child nutrition knowledge questionnaire is a valid and reliable tool to assess nutritional knowledge in schoolchildren in Kuwait. Nutrition knowledge of Kuwaiti schoolchildren should be improved using age-appropriate interventions in school.",2020,The Kuwait child nutrition knowledge questionnaire is a valid and reliable tool to assess nutritional knowledge in schoolchildren in Kuwait.,"['642 schoolchildren (8-12 years', 'Kuwaiti schoolchildren', 'schoolchildren in Kuwait', ""Kuwaiti primary-school children, and measured children's nutrition knowledge before and after a nutrition awareness intervention""]",['nutrition knowledge questionnaire'],"['nutrition knowledge presentation', 'content validity and moderate to strong reliability', 'Validity, reliability and use of a Kuwait child nutrition knowledge assessment questionnaire', 'mean nutritional knowledge scores']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0022804', 'cui_str': 'Kuwait'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1720755', 'cui_str': 'Child nutrition'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0022804', 'cui_str': 'Kuwait'}, {'cui': 'C1720755', 'cui_str': 'Child nutrition'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0189521,The Kuwait child nutrition knowledge questionnaire is a valid and reliable tool to assess nutritional knowledge in schoolchildren in Kuwait.,"[{'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Ibrahim', 'Affiliation': 'Health Standards Organization, Standards & Evidence Development, Ottawa, Canada.'}, {'ForeName': 'Dima', 'Initials': 'D', 'LastName': 'AlKaed', 'Affiliation': 'Dasman Diabetes Institute, Health Standars Orgnization (HSD), Dasman, Kuwait.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Ismail', 'Affiliation': 'Dasman Diabetes Institute, Health Standars Orgnization (HSD), Dasman, Kuwait.'}, {'ForeName': 'Roula', 'Initials': 'R', 'LastName': 'Barake', 'Affiliation': 'Nutrition Department, Medical Division, Dasman, Kuwait.'}]",Eastern Mediterranean health journal = La revue de sante de la Mediterranee orientale = al-Majallah al-sihhiyah li-sharq al-mutawassit,['10.26719/2020.26.5.602']
2109,32538466,"Limited effectiveness of four oral antifungal drugs (fluconazole, griseofulvin, itraconazole and terbinafine) in the current epidemic of altered dermatophytosis in India: results of a randomized pragmatic trial.","BACKGROUND


Dermatophytic infections have undergone unprecedented changes in India in the recent past. Clinical trials to find out the effectiveness of the four main oral antifungal drugs are lacking.
OBJECTIVES


We tested the effectiveness of oral fluconazole, griseofulvin, itraconazole and terbinafine in chronic and chronic relapsing tinea corporis, tinea cruris and tinea faciei in an investigator-initiated, randomized, pragmatic trial.
METHODS


Two hundred patients with microscopy-confirmed tinea were allocated to four groups (50 patients in each group): fluconazole 5 mg kg -1  per day, griseofulvin 10 mg kg -1  per day, itraconazole 5 mg kg -1  per day and terbinafine 7·5 mg kg -1  per day. Allocation was performed by concealed block randomization and the patients were treated for 8 weeks or until cure. Effectiveness was calculated based on intention-to-treat analysis. The trial was registered with the Clinical Trials Registry India (CTRI/2017/04/008281).
RESULTS


At 4 weeks, all drugs were similarly ineffective, with cure rates being 8% or less (P = 0·42). At 8 weeks, the numbers of patients cured were as follows: fluconazole 21 (42%), griseofulvin seven (14%), itraconazole 33 (66%) and terbinafine 14 (28%) (P < 0·001). Itraconazole was superior to fluconazole, griseofulvin and terbinafine (adjusted P ≤ 0·048). Relapse rates after 4 and 8 weeks of cure with the four treatments were not different (P ≥ 0·42). Numbers needed to treat (vs. griseofulvin), calculated on the basis of cure rates at 8 weeks, were as follows: fluconazole 4, itraconazole 2 and terbinafine 8.
CONCLUSIONS


The results show limited effectiveness of all four antifungal drugs. In view of cure rates and the number needed to treat, itraconazole is the most effective drug, followed by fluconazole (daily), terbinafine and then griseofulvin, in chronic and chronic relapsing dermatophytosis in India.",2020,Relapse rates after 4 and 8 weeks of cure with the four treatments were not different (P ≥ 0·42).,"['altered dermatophytosis in India', 'Two hundred patients with microscopy-confirmed tinea']","['fluconazole, griseofulvin, itraconazole and terbinafine', 'fluconazole 5 mg kg -1  per day, griseofulvin 10 mg kg -1  per day, itraconazole', 'fluconazole', 'terbinafine', 'itraconazole', 'griseofulvin', 'Itraconazole', 'oral antifungal drugs (fluconazole, griseofulvin, itraconazole and terbinafine', 'fluconazole, griseofulvin and terbinafine', 'terbinafine 7·5']","['cure rates', 'Effectiveness', 'Relapse rates']","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011636', 'cui_str': 'Dermatophytosis'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026018', 'cui_str': 'Microscopy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0040247', 'cui_str': 'Tinea infection'}]","[{'cui': 'C0016277', 'cui_str': 'Fluconazole'}, {'cui': 'C0018242', 'cui_str': 'Griseofulvin'}, {'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0076110', 'cui_str': 'terbinafine'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003308', 'cui_str': 'Antifungal-containing product'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",200.0,0.0387624,Relapse rates after 4 and 8 weeks of cure with the four treatments were not different (P ≥ 0·42).,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Department of Dermatology and Venereology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Chandra', 'Affiliation': 'Department of Dermatology and Venereology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.'}, {'ForeName': 'V N', 'Initials': 'VN', 'LastName': 'Anchan', 'Affiliation': 'Department of Dermatology and Venereology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Verma', 'Affiliation': 'Department of Dermatology and Venereology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Tilak', 'Affiliation': 'Department of Microbiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.'}]",The British journal of dermatology,['10.1111/bjd.19146']
2110,32538495,Caffeine improves various aspects of athletic performance in adolescents independent of their 163 C>A CYP1A2 genotypes.,"The purpose of this study was to investigate whether variations in 163 C>A CYP1A2 genotypes (rs 762551) (AA, AC and CC) modify the ergogenic effects of caffeine (CAF) on strength, power, muscular endurance, agility and endurance in adolescent athletes.
METHODS


One hundred adolescents (age = 15 ± 2 years) were recruited. Participants ingested CAF (6 mg.kg -1  ) or placebo (PLA, 300 mg of cellulose) one hour before performing a sequence of physical tests: handgrip strength, vertical jumps, agility test, sit-ups, push-ups and the Yo-Yo intermittent recovery test level 1 (Yo-Yo IR1).
RESULTS


Compared to PLA, CAF enhanced (p < 0.05) sit-up (CAF = 37 ± 9; PLA = 35 ± 8 repetitions) and push-up repetitions (CAF = 26 ± 11; PLA = 24 ± 11 repetitions), and increased distance covered in Yo-Yo IR1 test (CAF = 1010.4 ± 378.9; PLA = 903.2 ± 325.7 m). There was no influence of CAF on handgrip strength (CAF = 35.1 ± 8.9; PLA = 33.7 ± 8.7 kgf), countermovement jump height (CAF = 49.3 ± 12.6; PLA = 47.9 ± 13.8 cm), spike jump height (CAF = 54.2 ± 13.6; PLA = 52.9 ± 14.5 cm), and time in agility test (CAF = 15.8 ± 1.1; PLA = 15.9 ± 1.3 s, p > 0.05). When present, the ergogenic effect of CAF was not dependent of genotype.
CONCLUSION


CAF improves muscular endurance and aerobic performance in adolescent athletes, regardless of their 163 C>A CYP1A2 genotype.",2020,"Compared to PLA, CAF enhanced (p < 0.05) sit-up (CAF = 37 ± 9; PLA = 35 ± 8 repetitions) and push-up repetitions (CAF = 26 ± 11; PLA = 24 ± 11 repetitions), and increased distance covered in Yo-Yo IR1 test (CAF = 1010.4 ± 378.9; PLA = 903.2 ± 325.7 m).","['163 C', 'One hundred adolescents (age = 15 ± 2 years) were recruited', 'adolescent athletes, regardless of their 163 C', 'adolescents independent of their 163 C', 'adolescent athletes']","['placebo (PLA, 300 mg of cellulose) one hour before performing a sequence of physical tests: handgrip strength, vertical jumps, agility test, sit-ups, push-ups and the Yo-Yo intermittent recovery test level 1 (Yo-Yo IR1', 'Caffeine', 'CAF', 'caffeine (CAF']","['CAF on handgrip strength', 'countermovement jump height', 'strength, power, muscular endurance, agility and endurance', 'spike jump height', 'muscular endurance and aerobic performance', 'time in agility test', 'athletic performance']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0332291', 'cui_str': 'Independent of'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0007648', 'cui_str': 'Cellulose'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0560837', 'cui_str': 'Does sit up'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0871966', 'cui_str': 'Sports Performance'}]",,0.023064,"Compared to PLA, CAF enhanced (p < 0.05) sit-up (CAF = 37 ± 9; PLA = 35 ± 8 repetitions) and push-up repetitions (CAF = 26 ± 11; PLA = 24 ± 11 repetitions), and increased distance covered in Yo-Yo IR1 test (CAF = 1010.4 ± 378.9; PLA = 903.2 ± 325.7 m).","[{'ForeName': 'Higor', 'Initials': 'H', 'LastName': 'Spineli', 'Affiliation': 'Postgraduate Program in Nutrition - PPGNUT - Federal University of Alagoas, Alagoas, Brazil.'}, {'ForeName': 'Maryssa Pontes', 'Initials': 'MP', 'LastName': 'Pinto', 'Affiliation': 'Postgraduate Program in Nutrition - PPGNUT - Federal University of Alagoas, Alagoas, Brazil.'}, {'ForeName': 'Bruna Priscila', 'Initials': 'BP', 'LastName': 'Dos Santos', 'Affiliation': 'Postgraduate Program in Health Sciences - PPGCS - Federal University of Alagoas, Alagoas, Brazil.'}, {'ForeName': 'Adriano Eduardo', 'Initials': 'AE', 'LastName': 'Lima-Silva', 'Affiliation': 'Human Performance Research Group, Technological Federal University of Parana, Parana, Brazil.'}, {'ForeName': 'Romulo', 'Initials': 'R', 'LastName': 'Bertuzzi', 'Affiliation': 'Endurance Performance Research Group (GEDAE-USP), School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Daniel Leite Góis', 'Initials': 'DLG', 'LastName': 'Gitaí', 'Affiliation': 'Postgraduate Program in Health Sciences - PPGCS - Federal University of Alagoas, Alagoas, Brazil.'}, {'ForeName': 'Gustavo Gomes', 'Initials': 'GG', 'LastName': 'de Araujo', 'Affiliation': 'Postgraduate Program in Nutrition - PPGNUT - Federal University of Alagoas, Alagoas, Brazil.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13749']
2111,32538501,The effects of psychoeducation based on the cognitive-behavioral approach on premenstrual syndrome symptoms: A randomized controlled trial.,,2020,,['premenstrual syndrome symptoms'],['cognitive-behavioral approach'],[],"[{'cui': 'C0033046', 'cui_str': 'Premenstrual syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]",[],,0.0674141,,"[{'ForeName': 'Maisa Hamed', 'Initials': 'MH', 'LastName': 'Al Kiyumi', 'Affiliation': 'Department of Family Medicine and Public Health, Sultan Qaboos University Hospital, Muscat, Oman.'}]",Perspectives in psychiatric care,['10.1111/ppc.12532']
2112,32538535,What have we learned about how to prevent and treat antibody-mediated rejection in kidney transplantation?,"Antibody-mediated rejection (ABMR) in kidney transplantation is a major cause of late graft loss, and despite all efforts to date the ""standard of care"" remains plasmapheresis, IVIg, and steroids, which itself is based on low quality evidence. This review focuses on the risk factors leading to memory and de novo donor-specific antibody (DSA)-associated ABMR, the optimal prevention strategies for ABMR, and advances in  adjunctive and emerging therapies for ABMR. Because new agents require regulatory approval via a Phase 3 randomized control trial (RCT), an overview of progress in innovative trial design for ABMR is provided. Finally, based on the insights gained in the biology of ABMR, current knowledge gaps are identified for future research that could significantly affect our understanding of how to optimally treat ABMR.",2020,"This review focuses on the risk factors leading to memory and de novo donor-specific antibody (DSA)-associated ABMR, the optimal prevention strategies for ABMR, and advances in  adjunctive and emerging therapies for ABMR.",[],['Antibody-mediated rejection (ABMR'],[],[],"[{'cui': 'C1608421', 'cui_str': 'Antibody-mediated rejection'}]",[],,0.0232235,"This review focuses on the risk factors leading to memory and de novo donor-specific antibody (DSA)-associated ABMR, the optimal prevention strategies for ABMR, and advances in  adjunctive and emerging therapies for ABMR.","[{'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Nickerson', 'Affiliation': 'Department of Internal Medicine, Max Rady College of Medicine, University of Manitoba, Winnipeg, Canada.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.15859']
2113,32538550,"Insulin glargine 300 U/mL versus first-generation basal insulin analogues in insulin-naïve adults with type 2 diabetes: 12-month outcomes of ACHIEVE Control, a prospective, randomised, pragmatic real-life clinical trial.","AIMS


ACHIEVE Control, a prospective pragmatic randomised real-life study in insulin-naïve adults with type 2 diabetes (T2D), demonstrated statistical superiority of insulin glargine 300 U/mL (Gla-300) over first-generation standard-of-care basal insulin analogues (SOC-BI; insulin glargine 100 U/mL or insulin detemir) for the primary composite endpoint of individualised HbA1c target achievement without documented symptomatic (≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycaemia at 6 months. Here, we report effectiveness and safety of Gla-300 versus SOC-BI in ACHIEVE Control at 12 months.
METHODS


3304 insulin-naïve adults with T2D and HbA1c 8%-11% after ≥1 year of treatment with ≥2 antihyperglycaemic agents were randomised to Gla-300 or SOC-BI. Key secondary endpoints included HbA1c target attainment without documented symptomatic or severe hypoglycaemia (≤3.9 mmol/L [≤70 mg/dL]) at 12 months.
RESULTS


At 12 months, 26.1% (Gla-300) and 23.7% (SOC-BI) of adults achieved HbA1c targets without documented symptomatic (≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycaemia (odds ratio [OR] 1.14, 95% CI 0.97-1.35); 33.0% and 29.5%, respectively, achieved HbA1c targets without documented symptomatic (<3.0 mmol/L [<54 mg/dL]) or severe hypoglycaemia (OR 1.19, 95% CI 1.02-1.38). Odds ratio for HbA1c target achievement was 1.15 (95% CI 0.99-1.34) and favoured Gla-300 versus SOC-BI for absence of documented symptomatic or severe hypoglycaemia at 12 months for both ≤3.9 mmol/L (≤70 mg/dL) (OR 1.21, 95% CI 1.05-1.40) and <3.0 mmol/L (<54 mg/dL) (OR 1.26, 95% CI 1.07-1.48).
CONCLUSION


Gla-300 tended to be associated with lower hypoglycemia risk than SOC-BI in real-world clinical practice during the 12-month follow-up. This article is protected by copyright. All rights reserved.",2020,Odds ratio for HbA1c target achievement was 1.15 (95% CI 0.99-1.34) and favoured Gla-300 versus SOC-BI for absence of documented symptomatic or severe hypoglycaemia at 12 months for both ≤3.9 mmol/L (≤70 mg/dL),"['3304 insulin-naïve adults with T2D and HbA1c 8%-11% after ≥1 year of treatment with ≥2 antihyperglycaemic agents', 'insulin-naïve adults with type 2 diabetes (T2D', 'insulin-naïve adults with type 2 diabetes']","['Gla-300 versus SOC-BI', 'Insulin glargine 300 U/mL versus first-generation basal insulin analogues', 'Gla-300 or SOC-BI', 'insulin glargine 300 U/mL (Gla-300) over first-generation standard-of-care basal insulin analogues (SOC-BI; insulin glargine 100 U/mL or insulin detemir']","['Odds ratio for HbA1c target achievement', 'severe hypoglycaemia', 'HbA1c target attainment without documented symptomatic or severe hypoglycaemia', 'symptomatic or severe hypoglycaemia', 'hypoglycemia risk']","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0537270', 'cui_str': 'insulin detemir'}]","[{'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C1318607', 'cui_str': 'HBA1c target'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",3304.0,0.161478,Odds ratio for HbA1c target achievement was 1.15 (95% CI 0.99-1.34) and favoured Gla-300 versus SOC-BI for absence of documented symptomatic or severe hypoglycaemia at 12 months for both ≤3.9 mmol/L (≤70 mg/dL),"[{'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Meneghini', 'Affiliation': 'University of Texas Southwestern Medical Center and Parkland Health & Hospital System, Dallas, Texas.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Blonde', 'Affiliation': 'Frank Riddick Diabetes Institute, Endocrinology Department, Ochsner Medical Center, New Orleans, Louisiana.'}, {'ForeName': 'Jasvinder', 'Initials': 'J', 'LastName': 'Gill', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Dauchy', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Andrius', 'Initials': 'A', 'LastName': 'Bacevicius', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Strong', 'Affiliation': 'Ascension Health, Stevens Point, Wisconsin.'}, {'ForeName': 'Timothy S', 'Initials': 'TS', 'LastName': 'Bailey', 'Affiliation': 'AMCR Institute, Escondido, California.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14116']
2114,32538561,[Clinical study on reconstruction of posterior cruciate ligament with platelet rich plasma combined with 3-strand peroneus longus tendons].,"Objective


To investigate the effectiveness of the reconstruction of posterior cruciate ligament (PCL) with platelet rich plasma (PRP) and 3-strand peroneal longus tendons under arthroscope.
Methods


Between June 2014 and December 2017, 58 patients with PCL rupture were randomly divided into two groups: the trial group (PRP assisted reconstruction of 3-strand peroneal longus tendons) and the control group (4-strand hamstring tendon reconstruction alone), 29 cases in each group. There was no significant difference in gender, age, injury side, Kellgren-Lawrence grade, time from injury to operation, and preoperative American Orthopaedic Foot and Ankle Society (AOFAS) ankle-hindfoot score, International Knee Documentation Committee (IKDC) score, Lysholm score between the two groups (  P >0.05). Before operation, at 3 months and 12 months after operation, the IKDC score and Lysholm score of the two groups were recorded to evaluate the knee joint function, AOFAS ankle-hindfoot score was used to evaluate ankle function; KT-2000 examination (knee flexion of 90°, 30 lbs) was used to evaluate the difference of bilateral knee joint posterior relaxation at 12 months after operation, and MRI was used to evaluate ligament reconstruction; CT was used to evaluate the bone tunnel expansion of femur and tibia at 3 months and 12 months after operation.
Results


The operation was completed successfully in both groups, there was no complication in the donor tendon area. All the incisions healed by first intention. All the patients were followed up for more than 1 year. The follow-up time of the trial group was 13-17 months, with an average of 15.0 months; that of the control group was 15-20 months, with an average of 15.4 months. At 3 and 12 months after operation, there was no significant difference in AOFAS ankle-hindfoot score when compared with preoperative score and between the two groups (  P >0.05). At 3 and 12 months after operation, the IKDC score and Lysholm score of the two groups were significantly improved, and further improvement was found at 12 months when compared with at 3 months (  P <0.05); the scores in the trial group were significantly better than those of the control group (  P <0.05). At 12 months after operation, the difference of the posterior relaxation of the bilateral knees in the trial group was less than 5 mm in 27 cases, 6-10 mm in 2 cases; in the control group was less than 5 mm in 20 cases, 6-10 mm in 6 cases, and >10 mm in 3 cases; the difference between the two groups was not significant (  Z =0.606,  P =0.544). At 12 months after operation, MRI of knee joint showed that all patients had good PCL graft. The MRI score of the trial group was better than that of the control group (  t =2.425,  P =0.019). CT examination at 3 and 12 months after operation showed that the bone tunnel expansion of femur and tibia in the trial group were significantly better than those in the control group (  P <0.05).
Conclusion


PRP combined with 3-stand peroneal longus tendons can significantly improve the function and stability of knee joint, effectively promote graft remodeling, and promote tendon bone healing, reduce the expansion of bone tunnel. The effectiveness is satisfactory.",2020,"At 3 and 12 months after operation, the IKDC score and Lysholm score of the two groups were significantly improved, and further improvement was found at 12 months when compared with at 3 months (  P <0.05); the scores in the trial group were significantly better than those of the control group (  P <0.05).","['Methods\n\n\nBetween June 2014 and December 2017, 58 patients with PCL rupture']","['posterior cruciate ligament with platelet rich plasma combined with 3-strand peroneus longus tendons', 'posterior cruciate ligament (PCL) with platelet rich plasma (PRP', 'trial group (PRP assisted reconstruction of 3-strand peroneal longus tendons) and the control group (4-strand hamstring tendon reconstruction alone']","['MRI of knee joint', 'AOFAS ankle-hindfoot score', 'IKDC score and Lysholm score', 'MRI score', 'knee joint function, AOFAS ankle-hindfoot score', 'bilateral knee joint posterior relaxation', 'posterior relaxation of the bilateral knees', 'CT examination', 'bone tunnel expansion of femur and tibia', 'gender, age, injury side, Kellgren-Lawrence grade, time from injury to operation, and preoperative American Orthopaedic Foot and Ankle Society (AOFAS) ankle-hindfoot score, International Knee Documentation Committee (IKDC) score, Lysholm score']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0080039', 'cui_str': 'Structure of posterior cruciate ligament of knee joint'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}]","[{'cui': 'C0080039', 'cui_str': 'Structure of posterior cruciate ligament of knee joint'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0224469', 'cui_str': 'Peroneus longus muscle structure'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0442035', 'cui_str': 'Peroneal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0559650', 'cui_str': 'Tendon reconstruction'}]","[{'cui': 'C0412714', 'cui_str': 'MRI of knee'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0230459', 'cui_str': 'Hindfoot'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0582801', 'cui_str': 'Bilateral knee joints'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0037455', 'cui_str': 'Societies'}]",58.0,0.0176895,"At 3 and 12 months after operation, the IKDC score and Lysholm score of the two groups were significantly improved, and further improvement was found at 12 months when compared with at 3 months (  P <0.05); the scores in the trial group were significantly better than those of the control group (  P <0.05).","[{'ForeName': 'Shichun', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Orthopaedics, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou Fujian, 363000, P.R.China.'}, {'ForeName': 'Wenxiang', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': 'Department of Orthopaedics, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou Fujian, 363000, P.R.China.'}, {'ForeName': 'Weihua', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopaedics, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou Fujian, 363000, P.R.China.'}, {'ForeName': 'Honghan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedics, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou Fujian, 363000, P.R.China.'}]",Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery,['10.7507/1002-1892.201910115']
2115,32538577,The impact of tracheal-tube introducer guided intubation in anticipated non-difficult airway on postoperative sore throat: a randomized controlled trial.,"BACKGROUND


The passage of tube across the glottis-inlet being the significant 'active' component of intubation, associating postoperative sore throat (POST) with 'passive' presence of high-volume low-pressure tracheal-tube cuff is unjustified. Tracheal-tube introducers (TTI), commonly employed to facilitate tracheal intubation during difficult airway management, can influence intubation quality and decrease incidence of POST.
METHODS


Four hundred and fifty patients undergoing laparoscopic/open surgery were randomly allocated to receive conventional intubation (Non-TTI group, n=150) or intubation facilitated with rigid-TTI (Rigid-TTI group, n=150) or non-rigid TTI (Non-rigid TTI group, n=150). This study analysed effects of conventional versus TTI-guided intubation on reducing the incidence of POST (primary objective); intubation profile (time, attempts, response), and complications (trauma, inspiratory stridor) (secondary objectives).
RESULTS


Four hundred and twenty patients completed the study. The incidence of POST was lowest in patients of 'Rigid-TTI group' (n=40, 29.0%); which was significantly lower than the 'Non-TTI' group (n=64, 45.1%) (P=0.005) but comparable to the 'Non-Rigid-TTI' group (n=53, 37.9%, P=0.117). In addition, the incidence of POST in 'Rigid-TTI' group was significantly lower than those in the 'non-TTI' group at 2-hour ('Rigid-TTI' group: n=19, 13.8%, 'Non-TTI' group: n=41, 28.9%; P=0.002) and 4-hour ('Rigid-TTI' group: n=23, 16.7%, 'Non-TTI' group: n=43, 30.3%, P=0.007) time points. No difference was found in the incidence of airway management related morbidity, including, laryngospasm and inspiratory stridor in the three groups.
CONCLUSIONS


Rigid-TTI by its ability to positively modify friction dynamics between glottis- inlet and the passing tracheal-tube; has the potential to improve quality of intubation and decrease the incidence of POST.",2020,"No difference was found in the incidence of airway management related morbidity, including, laryngospasm and inspiratory stridor in the three groups.
","['Four hundred and fifty patients undergoing laparoscopic/open surgery', 'Four hundred and twenty patients completed the study']","['tracheal-tube introducer guided intubation', 'conventional intubation (Non-TTI group, n=150) or intubation facilitated with rigid-TTI (Rigid-TTI group, n=150) or non-rigid TTI', 'conventional versus TTI-guided intubation', 'Tracheal-tube introducers (TTI']","['incidence of POST', 'incidence of airway management related morbidity, including, laryngospasm and inspiratory stridor', 'incidence of POST (primary objective); intubation profile (time, attempts, response), and complications (trauma, inspiratory stridor) (secondary objectives']","[{'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}, {'cui': 'C4517774', 'cui_str': '420'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1260970', 'cui_str': 'Tracheal tube'}, {'cui': 'C0456642', 'cui_str': 'Introducer'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0150126', 'cui_str': 'Airway management'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023066', 'cui_str': 'Laryngeal spasm'}, {'cui': 'C0677600', 'cui_str': 'Inspiratory stridor'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",450.0,0.0976392,"No difference was found in the incidence of airway management related morbidity, including, laryngospasm and inspiratory stridor in the three groups.
","[{'ForeName': 'Amitabh', 'Initials': 'A', 'LastName': 'Dutta', 'Affiliation': 'Department of Anaesthesiology, Pain, &amp; Perioperative Medicine, Sir Ganga Ram Hospital, New Delhi, India.'}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Sethi', 'Affiliation': 'Department of Anaesthesiology, Pain, &amp; Perioperative Medicine, Sir Ganga Ram Hospital, New Delhi, India - nitinsethi77@yahoo.co.in.'}, {'ForeName': 'Prabhat', 'Initials': 'P', 'LastName': 'Choudhary', 'Affiliation': 'Department of Anaesthesiology, Pain, &amp; Perioperative Medicine, Sir Ganga Ram Hospital, New Delhi, India.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Gupta', 'Affiliation': 'Department of Anaesthesiology, Pain, &amp; Perioperative Medicine, Sir Ganga Ram Hospital, New Delhi, India.'}, {'ForeName': 'Savitar', 'Initials': 'S', 'LastName': 'Malhotra', 'Affiliation': 'Department of Anaesthesiology, Pain, &amp; Perioperative Medicine, Sir Ganga Ram Hospital, New Delhi, India.'}, {'ForeName': 'Bhuwan C', 'Initials': 'BC', 'LastName': 'Panday', 'Affiliation': 'Department of Anaesthesiology, Pain, &amp; Perioperative Medicine, Sir Ganga Ram Hospital, New Delhi, India.'}, {'ForeName': 'Jayashree', 'Initials': 'J', 'LastName': 'Sood', 'Affiliation': 'Department of Anaesthesiology, Pain, &amp; Perioperative Medicine, Sir Ganga Ram Hospital, New Delhi, India.'}, {'ForeName': 'Shvet', 'Initials': 'S', 'LastName': 'Mahajan', 'Affiliation': 'Department of Anaesthesiology, Pain, &amp; Perioperative Medicine, Sir Ganga Ram Hospital, New Delhi, India.'}]",Minerva anestesiologica,['10.23736/S0375-9393.20.14257-3']
2116,32538682,Modified transperitoneal versus retroperitoneal laparoscopic radical nephroureterectomy in the management of upper urinary tract urothelial carcinoma: Best practice in a single center with updated results.,"OBJECTIVE


Radical nephroureterectomy remains the gold standard for the surgical treatment of upper urinary tract urothelial carcinoma (UTUC). Based on previous research, we prospectively compared the advantages of transperitoneal laparoscopic radical nephroureterectomy (TLNU) with a three-port technique in a single position versus retroperitoneal laparoscopic radical nephroureterectomy (RLNU).
METHODS


We evaluated 48 patients diagnosed with UTUC at our institution from January 2015 to October 2019. The patients underwent either TLNU (n = 24) or RLNU (n = 24). We randomly assigned the patients to each technique group based on their body mass index because our experience has shown that the body mass index is the main interfering factor for this surgery. The baseline characteristics and perioperative outcomes were compared between the groups.
RESULTS


We found no significant differences in the baseline characteristics, time until recovery of intestinal function, or postoperative hospital stay between the two groups. However, the TLNU group had a shorter operation time and better postoperative pain control than the RLNU group.
CONCLUSION


Modified TLNU is associated with a shorter operative time and less severe postoperative pain compared with RLNU. Both techniques are safe and reliable with adequate management, and their therapeutic effects are comparable in other aspects.",2020,"We found no significant differences in the baseline characteristics, time until recovery of intestinal function, or postoperative hospital stay between the two groups.","['48 patients diagnosed with UTUC at our institution from January 2015 to October 2019', 'upper urinary tract urothelial carcinoma', 'upper urinary tract urothelial carcinoma (UTUC']","['Radical nephroureterectomy', 'Modified TLNU', 'transperitoneal laparoscopic radical nephroureterectomy (TLNU', 'Modified transperitoneal versus retroperitoneal laparoscopic radical nephroureterectomy', 'retroperitoneal laparoscopic radical nephroureterectomy (RLNU', 'TLNU', 'RLNU']","['severe postoperative pain', 'shorter operation time and better postoperative pain control', 'baseline characteristics, time until recovery of intestinal function, or postoperative hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1508753', 'cui_str': 'Urinary system structure'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}, {'cui': 'C1282910', 'cui_str': 'Upper'}]","[{'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0027732', 'cui_str': 'Nephroureterectomy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205501', 'cui_str': 'Transperitoneal approach'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0035359', 'cui_str': 'Retroperitoneal'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",48.0,0.042489,"We found no significant differences in the baseline characteristics, time until recovery of intestinal function, or postoperative hospital stay between the two groups.","[{'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Ye', 'Affiliation': 'Department of Urology, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Zhong', 'Affiliation': 'Department of Urology, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Department of Urology, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Jiannan', 'Initials': 'J', 'LastName': 'Ren', 'Affiliation': 'Department of Urology, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Xiao', 'Affiliation': 'Department of Urology, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xiong', 'Affiliation': 'Department of Urology, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}]",The Journal of international medical research,['10.1177/0300060520928788']
2117,32538746,Uninfluenced alpha-fetoprotein and treatment of liver primary carcinoma by lobaplatin in combination with 5-fluorouracil and doxorubicin via chemoembolization and transarterial chemoembolization.,"Alpha-fetoprotein (AFP) is a protein encoded by the AFP gene and normally produced by the fetus. The purpose of this study is to investigate the efficacy of lobaplatin in combination with 5-fluorouracil (5-FU) and doxorubicin on AFP and treatment of primary carcinoma of the liver by transhepatic arterial chemotherapy and embolization (TACE). Patients with primary carcinoma of the liver who took the TACE for treatment were enrolled in this study and divided randomly into the research group and the control group. Patients in the research group adopted the TACE in combination with lobaplatin, while those in the control group took cisplatin instead in combination with TACE. We compared the baseline data, hepatic indicators before treatment and after 1 month of treatment, efficacy and the incidence rates of adverse events after TACE between two groups. Differences in the baseline data, including Child-pugh grade, type of liver cirrhosis, KPS scores and AFP showed no statistical significance (P &gt;0.05). Before the treatment, we identified no significant differences in the comparison of ALT, AST, TBiL and ALB between two groups (P &gt;0.05), while significant differences emerged after treatment (P &lt;0.05). Also, efficacy comparison revealed the significant difference between the two groups (P &lt;0.05). After TACE, patients in the research group reported 1 case of nausea, 1 of vomiting and 1 of necrotic absorption fever, and those in the control group reported 3 cases of nausea, 5 of vomiting and 4 of necrotic absorption fever, with a significant difference in comparison of the incidence rates (P &lt;0.05). TACE is a promising strategy for the treatment of primary carcinoma of the liver, while lobaplatin, as the 3rd generation of anti-tumor platinum-based drugs, is less toxic than cisplatin, but excels in efficacy.",2020,"Before the treatment, we identified no significant differences in the comparison of ALT, AST, TBiL and ALB between two groups (P &gt;0.05), while significant differences emerged after treatment (P &lt;0.05).","['primary carcinoma of the liver by transhepatic arterial chemotherapy and embolization (TACE', 'Patients with primary carcinoma of the liver who took the']","['5-fluorouracil (5-FU) and doxorubicin', 'TACE', 'cisplatin', '5-fluorouracil and doxorubicin via chemoembolization and transarterial chemoembolization', 'Alpha-fetoprotein (AFP', 'cisplatin instead in combination with TACE']","['nausea, 1 of vomiting and 1 of necrotic absorption fever', 'comparison of ALT, AST, TBiL and ALB', 'incidence rates', 'nausea, 5 of vomiting and 4 of necrotic absorption fever', 'Child-pugh grade, type of liver cirrhosis, KPS scores and AFP']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0007097', 'cui_str': 'Carcinoma'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0522516', 'cui_str': 'Transhepatic approach'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0522516', 'cui_str': 'Transhepatic approach'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C0522522', 'cui_str': 'Transarterial approach'}, {'cui': 'C0002210', 'cui_str': 'Alpha fetoprotein'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001909', 'cui_str': 'Albania'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4050412', 'cui_str': 'Child-Pugh score'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky performance status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002210', 'cui_str': 'Alpha fetoprotein'}]",,0.0166259,"Before the treatment, we identified no significant differences in the comparison of ALT, AST, TBiL and ALB between two groups (P &gt;0.05), while significant differences emerged after treatment (P &lt;0.05).","[{'ForeName': 'Yongpin', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of emergency, Xinglin branch of the first affiliated hospital of Xiamen university, Xiamen, Zhejiang361021, China.'}, {'ForeName': 'Weibin', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of general surgery, Qianwei hospital of Jilin Province, Changchun, Jilin 130012, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Department of blood transfusion, the second department of the first hospital of Jilin university, Changchun, Jilin 130021, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Changjiang', 'Initials': 'C', 'LastName': 'Zeng', 'Affiliation': ''}]","Cellular and molecular biology (Noisy-le-Grand, France)",[]
2118,32538747,"Parenteral nutrition effects of Omega-3 fatty acids on C-reactive protein, high-density lipoprotein, lymphocyte characteristics and the treatment of critically ill patients.","To study the effects of omega-3 fatty acid parenteral nutrition on the nutrition, inflammatory responses, immunity and prognoses of critically ill cancer patients. A total of 80 critically ill cancer patients were randomly divided into an observation group and a control group, 40 cases in each group. Both groups of patients received equal-nitrogen and equal-calorie enteral and parenteral nutrition. The observation group, on this basis, was added with omega-3 fatty acid parenteral nutrition. The weekly nutritional status measures, inflammatory response measures, immune function measures and prognosis measures (ICU mortality, ICU stay, infectious complications) of the two groups were observed. The nutrition, inflammatory response and immune measures of the observation group were improved compared with the control group. The ICU stay in the observation group was shorter than the control group. Compared with the control group, the ICU mortality rate and infectious complication rate were lower in the observation group, but the differences were not significant (P mortality = 0.13, P infection rate = 0.165). Omega-3 fatty acid parenteral nutrition could improve patients' nutritional status and immune function, reduce the body's inflammatory responses and shorten the length of hospital stay, but couldn't significantly improve ICU mortality and reduce the incidence of infectious complications.",2020,"Compared with the control group, the ICU mortality rate and infectious complication rate were lower in the observation group, but the differences were not significant (P mortality = 0.13, P infection rate = 0.165).","['critically ill cancer patients', 'critically ill patients', '80 critically ill cancer patients']","['omega-3 fatty acid parenteral nutrition', 'Omega-3 fatty acids', 'Omega-3 fatty acid parenteral nutrition', 'equal-nitrogen and equal-calorie enteral and parenteral nutrition']","[""patients' nutritional status and immune function"", 'C-reactive protein, high-density lipoprotein, lymphocyte characteristics', 'ICU mortality rate and infectious complication rate', 'ICU stay', 'weekly nutritional status measures, inflammatory response measures, immune function measures and prognosis measures (ICU mortality, ICU stay, infectious complications', 'ICU mortality', 'nutrition, inflammatory response and immune measures']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0439662', 'cui_str': 'Immune'}]",80.0,0.0118163,"Compared with the control group, the ICU mortality rate and infectious complication rate were lower in the observation group, but the differences were not significant (P mortality = 0.13, P infection rate = 0.165).","[{'ForeName': 'Chunhua', 'Initials': 'C', 'LastName': 'Ni', 'Affiliation': ""ICU, the First People's Hospital of Kunshan, Jiangsu, China.""}, {'ForeName': 'Jianxun', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': ""Department of radiology, Gansu provincial people's hospital, Lanzhou, Gansu, China.""}, {'ForeName': 'Dechuan', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of General Surgery, Baian Branch of Chongqing Three Gorges Central Hospital, Chongqing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': ""Emergency Department, Qinghai Provincial People's Hospital, Xining, Qinghai, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'Department of Pediatrics, Gansu Provincial Maternity and Child-Care Hospital, Xining, Qinghai, China.'}, {'ForeName': 'Chaoyun', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': ""Emergency department, Yixing People's Hospital, Yixing, Jiangsu, China.""}]","Cellular and molecular biology (Noisy-le-Grand, France)",[]
2119,32538762,"Effects of dezocine and ropivacaine infiltration anesthesia on cellular immune function indicators, anesthesia recovery time and pain factors in patients with open liver resection.","The current experiment was carried out to explore the effects of dezocine combined with ropivacaine infiltration anesthesia on the anesthesia recovery time and pain factors of patients with open hepatectomy. A prospective randomized controlled method was used to select 92 patients with open liver cancer resection in our hospital from August 2017 to November 2019. The patients were divided into a study group (n=46) and a control group (n=46) using a computer-generated random number table. Both groups underwent general anesthesia, based on this, the study group was treated with ropivacaine infiltration anesthesia 10 minutes before skin incision, and dezocine was given intravenously 0.5 h before surgery, the control group was anesthetized with ropivacaine 10 minutes before the incision, and was given a saline injection 0.5 h before the operation. Compared the recovery of anesthesia (recovery time of spontaneous breathing, time to open eyes, time to extubation), the incidence of adverse reactions, and cellular immune function indicators (peripheral blood CD4+, CD4+/CD8+, NK cell levels), stress response indicators [serum blood glucose (Glu), norepinephrine (NE), adrenaline (E)], pain factors [serum dopamine (DA), neuropeptide Y (NPY), substance P (SP)] before induction of anesthesia (T0), completion of surgery (T1), 12 hours after surgery (T2), and 24 hours after surgery (T3) between the two groups, and the degree of pain (VAS score) at T2 and T3 were compared between the two groups. The levels of CD4+, CD4+/CD8+, and NK cells in peripheral blood at T1, T2, and T3 in the study group were higher than those in the control group (P&lt;0.05); serum Glu, NE, and E levels in the study group at T1, T2, and T3 were lower than those in the control group (P&lt;0.05); serum DA, NPY, and SP levels in the study group at T1, T2, and T3 were lower than those in the control group (P&lt;0.05); the VAS scores of the study group at T2 and T3 were lower than those of the control group (P&lt;0.05); the time of spontaneous breathing recovery, eyes opening and extubation in the study group were shorter than those in the control group (P&lt;0.05); the incidence of restlessness (4.35%), transient hypertension (6.52%), and cough (2.17%) in the study group were lower than those in the control group (P&lt;0.05). Dezocine and ropivacaine infiltration anesthesia can significantly shorten the recovery time of anesthesia and inhibit pain factor secretion in patients with open hepatectomy and can reduce the body's stress response after surgery, reduce immune function fluctuations, and can reduce the incidence of adverse reactions to anesthesia, and help promote patients' postoperative recovery.",2020,"Dezocine and ropivacaine infiltration anesthesia can significantly shorten the recovery time of anesthesia and inhibit pain factor secretion in patients with open hepatectomy and can reduce the body's stress response after surgery, reduce immune function fluctuations, and can reduce the incidence of adverse reactions to anesthesia, and help promote patients' postoperative recovery.","['patients with open liver resection', '92 patients with open liver cancer resection in our hospital from August 2017 to November 2019', 'patients with open hepatectomy']","['control group (n=46) using a computer-generated random number table', 'ropivacaine infiltration anesthesia 10 minutes before skin incision, and dezocine', 'ropivacaine', 'Dezocine', 'dezocine and ropivacaine infiltration anesthesia', 'dezocine', 'ropivacaine infiltration anesthesia']","['recovery of anesthesia (recovery time of spontaneous breathing, time to open eyes, time to extubation), the incidence of adverse reactions, and cellular immune function indicators (peripheral blood CD4+, CD4+/CD8+, NK cell levels), stress response indicators [serum blood glucose (Glu), norepinephrine (NE), adrenaline (E)], pain factors [serum dopamine (DA), neuropeptide Y (NPY), substance P (SP)] before induction of anesthesia (T0), completion of surgery (T1), 12 hours after surgery (T2', 'transient hypertension', 'cough', 'incidence of restlessness', 'serum DA, NPY, and SP levels', 'VAS scores', 'cellular immune function indicators, anesthesia recovery time and pain factors', 'levels of CD4+, CD4+/CD8+, and NK cells in peripheral blood', 'degree of pain (VAS score', 'serum Glu, NE, and E levels', 'time of spontaneous breathing recovery, eyes opening and extubation', 'anesthesia recovery time and pain factors']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0345904', 'cui_str': 'Malignant neoplasm of liver'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039224', 'cui_str': 'Table'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0234945', 'cui_str': 'Infiltration anaesthesia'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0191279', 'cui_str': 'Incision of skin'}, {'cui': 'C0057626', 'cui_str': 'dezocine'}]","[{'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0266574', 'cui_str': 'Ablepharon'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0022688', 'cui_str': 'NK-cell'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0027893', 'cui_str': 'Neuropeptide Y'}, {'cui': 'C0038585', 'cui_str': 'Substance P'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0152170', 'cui_str': 'Transient hypertension'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}]",92.0,0.0165558,"Dezocine and ropivacaine infiltration anesthesia can significantly shorten the recovery time of anesthesia and inhibit pain factor secretion in patients with open hepatectomy and can reduce the body's stress response after surgery, reduce immune function fluctuations, and can reduce the incidence of adverse reactions to anesthesia, and help promote patients' postoperative recovery.","[{'ForeName': 'Ronggang', 'Initials': 'R', 'LastName': 'Zhu', 'Affiliation': ""Department of Pharmacy, Jinan 2nd People's Hospital, Jinan, 250001, China.""}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Du', 'Affiliation': ""Department of Pharmacy, Jinan 2nd People's Hospital, Jinan, 250001, China.""}, {'ForeName': 'Hongzhu', 'Initials': 'H', 'LastName': 'Gao', 'Affiliation': ""Department of Pharmacy, The People's Hospital of Huaiyin Jinan, Jinan, 250021, China.""}]","Cellular and molecular biology (Noisy-le-Grand, France)",[]
2120,32538776,Clinical effects of Lactobacillus strains as probiotics in the treatment of irritable bowel syndrome. Results from the LAPIBSS trial: Future objectives.,"The objective of this communication is to present and analyze the recent results from the LAPIBSS study in order to improve future clinical trials on the effects of Lactobacillus strains in the treatment of irritable bowel syndrome (IBS). Using a tightly-controlled clinical trial protocol with the highest Jadad score of 5/5, the current trial aimed to demonstrate the efficacy of a 2-strain mixture of Lactobacillus acidophilus (L. acidophilus) to improve IBS symptoms. Eighty patients diagnosed with IBS according to Rome III criteria were recruited to a multicentric, double-blind, in parallel groups, placebo-controlled, randomized clinical trial. Patients were provided with a daily dose of two capsules containing either two probiotic strains (5 x 109 cfu/capsule) or placebo for 8 weeks. The primary endpoint was abdominal pain score assessed with a 100-mm visual analogue scale (VAS). Secondary endpoints included scores of bloating, flatus and rumbling assessed with a 100-mm VAS, a composite score that consisted of the sum of the 4 VAS scores, and the stool frequency and consistency assessed with the Bristol Stool Form Scale. Our study has failed to demonstrate a significant improvement of the primary endpoint of abdominal pain. Significant differences between groups were observed for flatus score at week 4 (P=0.04) and week 8 (P=0.03) and for composite score at week 8 (P=0.04). The consumption of the 2-strain mixture of L. acidophilus over 8 weeks is safe, significantly decreases flatus and composite scores. The significant effect on flatus could result from the species-specific homofermentative properties of L. acidophilus strains. The negative results on abdominal pain and the gained experience are discussed for the future clinical trials in IBS.",2020,Significant differences between groups were observed for flatus score at week 4 (P=0.04) and week 8 (P=0.03) and for composite score at week 8 (P=0.04).,"['Eighty patients diagnosed with IBS according to Rome III criteria', 'irritable bowel syndrome', 'irritable bowel syndrome (IBS']","['2-strain mixture of Lactobacillus acidophilus (L. acidophilus', 'Lactobacillus strains', 'placebo']","['scores of bloating, flatus and rumbling assessed with a 100-mm VAS, a composite score that consisted of the sum of the 4 VAS scores, and the stool frequency and consistency assessed with the Bristol Stool Form Scale', 'flatus score', 'IBS symptoms', 'abdominal pain score assessed with a 100-mm visual analogue scale (VAS', 'flatus and composite scores', 'abdominal pain']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1997606', 'cui_str': 'Bristol stool form scale'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}]",80.0,0.178994,Significant differences between groups were observed for flatus score at week 4 (P=0.04) and week 8 (P=0.03) and for composite score at week 8 (P=0.04).,"[{'ForeName': 'Jean Michel', 'Initials': 'JM', 'LastName': 'Maixent', 'Affiliation': 'Pierre Deniker Clinical Research Unit, Henri Laborit University Hospital, Poitiers, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Pons', 'Affiliation': 'IAPS Laboratory, University of Toulon, Toulon, France.'}, {'ForeName': 'Souad R', 'Initials': 'SR', 'LastName': 'Sennoune', 'Affiliation': 'Department of Cellular Physiology and Molecular Biophysics, Texas Tech University Health Sciences Center, Lubbock, USA.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Sadrin', 'Affiliation': 'Laboratoire Denel-Codifra, Le Chesnay, France.'}]","Cellular and molecular biology (Noisy-le-Grand, France)",[]
2121,32538796,Usability of a Consumer Health Informatics Tool Following Completion of a Clinical Trial: Focus Group Study.,"BACKGROUND


Mobile health (mHealth) apps have the potential to be effective tools for encouraging patients with chronic diseases to self-manage their health. The success of mHealth apps is related to technology acceptance and its subsequent use by intended consumers. Therefore, it is essential to gain insights from consumers' perspectives about their use of mHealth apps in daily life.
OBJECTIVE


The purpose of this work was to understand consumers' perspectives on use of a self-management app following completion of a clinical trial that tested the efficacy of the app for improving health outcomes.
METHODS


We conducted five focus groups with paricipants of a clinical trial (NCT03182738) who were randomized to use the video information provider (VIP) for HIV-associated nonAIDS (HANA) conditions app (VIP-HANA) or an attention control app. Thematic analysis was conducted, and the themes were organized according to the two key constructs of the technology acceptance model framework: perceived usefulness and perceived ease of use.
RESULTS


Thirty-nine people living with HIV (20 from the intervention group and 19 from the control group) participated in the focus group sessions. Of the eight themes identified from focus group data, the five themes related to perceived usefulness were: (1) self-monitoring HIV-related symptoms of HANA conditions, (2) enhanced relationship with clinical providers, (3) improvement in physical and emotional health, (4) long-term impact of self-care strategies on improvement in symptoms of HANA conditions, and (5) inspired lifestyle changes to manage symptoms. The three themes related to perceived ease of use were: (1) easy to navigate, (2) avatar personalization, and (3) privacy/confidentiality maintained even when changing the location of app use.
CONCLUSIONS


Perceived ease of use was similar in both study groups but perceived usefulness differed between study groups. Participants in both study groups found the VIP-HANA app to be useful in monitoring their symptoms and enhancing communication with their clinical care providers. However, only intervention group participants perceived the app to be useful in improving overall health and long-term symptom management. Findings from this study highlight factors that are essential to ensure the usefulness of self-management apps and facilitate sustained use of mHealth apps for people living with chronic illnesses.",2020,Participants in both study groups found the VIP-HANA app to be useful in monitoring their symptoms and enhancing communication with their clinical care providers.,"['patients with chronic diseases to self-manage their health', 'people living with chronic illnesses', 'Thirty-nine people living with HIV (20 from the intervention group and 19 from the control group) participated in the focus group sessions']",['video information provider (VIP) for HIV-associated nonAIDS (HANA) conditions app (VIP-HANA) or an attention control app'],"['self-monitoring HIV-related symptoms of HANA conditions, (2) enhanced relationship with clinical providers, (3) improvement in physical and emotional health, (4) long-term impact of self-care strategies on improvement in symptoms of HANA conditions, and (5) inspired lifestyle changes to manage symptoms', 'overall health and long-term symptom management']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}]",39.0,0.0429502,Participants in both study groups found the VIP-HANA app to be useful in monitoring their symptoms and enhancing communication with their clinical care providers.,"[{'ForeName': 'Hwayoung', 'Initials': 'H', 'LastName': 'Cho', 'Affiliation': 'College of Nursing, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Porras', 'Affiliation': 'School of Nursing, Columbia University, New York, NY, United States.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Flynn', 'Affiliation': 'School of Nursing, Columbia University, New York, NY, United States.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Schnall', 'Affiliation': 'School of Nursing, Columbia University, New York, NY, United States.'}]",Journal of medical Internet research,['10.2196/17708']
2122,32538835,Impact of Serum Calcium Levels on Alzheimer's Disease: A Mendelian Randomization Study.,"BACKGROUND


Altered calcium homeostasis is hypothesized to underlie Alzheimer's disease (AD). However, it remains unclear whether serum calcium levels are genetically associated with AD risk.
OBJECTIVE


To develop effective therapies, we should establish the causal link between serum calcium levels and AD.
METHODS


Here, we performed a Mendelian randomization study to investigate the causal association of increased serum calcium levels with AD risk using the genetic variants from a large-scale serum calcium genome-wide association study (GWAS) dataset (61,079 individuals of European descent) and a large-scale AD GWAS dataset (54,162 individuals including 17,008 AD cases and 37,154 controls of European descent). Here, we selected the inverse-variance weighted (IVW) as the main analysis method. Meanwhile, we selected other three sensitivity analysis methods to examine the robustness of the IVW estimate.
RESULTS


IVW analysis showed that the increased serum calcium level (per 1 standard deviation (SD) increase 0.5 mg/dL) was significantly associated with a reduced AD risk (OR = 0.57, 95% CI 0.35-0.95, p = 0.031). Meanwhile, all the estimates from other sensitivity analysis methods were consistent with the IVW estimate in terms of direction and magnitude.
CONCLUSION


In summary, we provided evidence that increased serum calcium levels could reduce the risk of AD. Meanwhile, randomized controlled study should be conducted to clarify whether diet calcium intake or calcium supplement, or both could reduce the risk of AD.",2020,"Meanwhile, all the estimates from other sensitivity analysis methods were consistent with the IVW estimate in terms of direction and magnitude.
","['61,079 individuals of European descent) and a large-scale AD GWAS dataset (54,162 individuals including 17,008 AD cases and 37,154 controls of European descent', ""Alzheimer's Disease""]",['diet calcium intake or calcium supplement'],"['serum calcium level', 'reduced AD risk', 'serum calcium levels']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C2350277', 'cui_str': 'Genome Wide Association Studies'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0301595', 'cui_str': 'Calcium diet'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C3540037', 'cui_str': 'Calcium supplement'}]","[{'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.0667333,"Meanwhile, all the estimates from other sensitivity analysis methods were consistent with the IVW estimate in terms of direction and magnitude.
","[{'ForeName': 'Yating', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Neurology and Tianjin Neurological Institute, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Haihua', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Beijing Institute for Brain Disorders, Capital Medical University, Beijing, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Academy for Advanced Interdisciplinary Studies, Peking University, Beijing, China.'}, {'ForeName': 'Zhifa', 'Initials': 'Z', 'LastName': 'Han', 'Affiliation': 'School of Medicine, School of Pharmaceutical Sciences, THU-PKU Center for Life Sciences, Tsinghua University, Beijing, China.'}, {'ForeName': 'Qing-Bin', 'Initials': 'QB', 'LastName': 'Ni', 'Affiliation': 'Postdoctoral Workstation, Taian City Central Hospital, Taian, Shandong, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Postdoctoral Workstation, Taian City Central Hospital, Taian, Shandong, China.'}, {'ForeName': 'Longcai', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Weifang Medical University, Weifang, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Pathology, The Affiliated Hospital of Weifang Medical University, Weifang, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'School of Life Science and Technology, Harbin Institute of Technology, Harbin, China.'}, {'ForeName': 'Shuilin', 'Initials': 'S', 'LastName': 'Jin', 'Affiliation': 'Department of Mathematics, Harbin Institute of Technology, Harbin, China.'}, {'ForeName': 'Bao-Liang', 'Initials': 'BL', 'LastName': 'Sun', 'Affiliation': 'Department of Neurology, The Second Affiliated Hospital; Key Laboratory of Cerebral Microcirculation in Universities of Shandong; Shandong First Medical University & Shandong Academy of Medical Sciences, Taian, Shandong, China.'}, {'ForeName': 'Guiyou', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Beijing Institute for Brain Disorders, Capital Medical University, Beijing, China.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-191249']
2123,32538865,ParkinSong: Outcomes of a 12-Month Controlled Trial of Therapeutic Singing Groups in Parkinson's Disease.,"BACKGROUND


Parkinson's disease (PD) frequently causes progressive deterioration in speech, voice and cognitive aspects of communication. These affect wellbeing and quality of life and are associated with caregiver strain and burden. Therapeutic singing groups can ameliorate PD-related communication disorders and increase social interaction and wellbeing for caregivers and care recipients.
OBJECTIVE


To analyse the effects of ParkinSong group singing sessions on Parkinson's communication and wellbeing outcomes for people with PD and caregivers over 12 months.
METHODS


A 4-armed controlled clinical trial compared ParkinSong with active non-singing control conditions over 12 months. Two dosage levels (weekly versus monthly) were available for each condition. ParkinSong comprised high-effort vocal, respiratory and speech exercises, group singing, and social interaction. PD-specific outcomes included vocal loudness, speech intelligibility, maximum phonation time, respiratory muscle strength, and voice related quality of life (QoL). Wellbeing outcomes were also measured for caregivers and care recipients.
RESULTS


We recruited 75 people with PD and 44 caregivers who attended weekly ParkinSong, monthly ParkinSong, weekly control or monthly control groups. We found significant improvements in the primary outcome of vocal loudness (p = 0.032), with weekly singers 5.13 dB louder (p = 0.044) and monthly singers 5.69 dB louder (p = 0.015) than monthly controls at 12 months. ParkinSong participants also showed greater improvements in voice-related QoL and anxiety. Caregivers who attended ParkinSong showed greater reductions in depression and stress scores.
CONCLUSIONS


This 12-month controlled clinical trial of ParkinSong demonstrated improvements in speech loudness and voice-related QoL for participants with PD, and enhanced wellbeing for both caregivers and care recipients. No adverse effects were reported over 12 months and improvements were sustained.",2020,"Therapeutic singing groups can ameliorate PD-related communication disorders and increase social interaction and wellbeing for caregivers and care recipients.
","['people with PD and caregivers over 12 months', '75 people with PD and 44 caregivers who attended weekly ParkinSong, monthly ParkinSong, weekly control or monthly control groups', 'caregivers and care recipients', 'participants with PD, and enhanced wellbeing for both caregivers and care recipients', ""Groups in Parkinson's Disease""]","['ParkinSong group singing sessions', 'Therapeutic Singing', 'ParkinSong with active non-singing control conditions']","[""Parkinson's communication and wellbeing outcomes"", 'vocal loudness, speech intelligibility, maximum phonation time, respiratory muscle strength, and voice related quality of life (QoL', 'voice-related QoL and anxiety', 'wellbeing and quality of life', 'speech loudness and voice-related QoL', 'vocal loudness', 'adverse effects', 'depression and stress scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0234857', 'cui_str': 'Singing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0234795', 'cui_str': 'Vocal intensity'}, {'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}, {'cui': 'C0234778', 'cui_str': 'Maximum phonation time'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0178733', 'cui_str': 'Loudness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",75.0,0.0520023,"Therapeutic singing groups can ameliorate PD-related communication disorders and increase social interaction and wellbeing for caregivers and care recipients.
","[{'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Tamplin', 'Affiliation': 'Faculty of Fine Arts and Music, The University of Melbourne, Southbank, Victoria, VIC, Australia.'}, {'ForeName': 'Meg E', 'Initials': 'ME', 'LastName': 'Morris', 'Affiliation': 'School of Allied Health, Human Services & Sport, La Trobe University, Bundoora, Victoria, VIC, Australia.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Marigliani', 'Affiliation': ""Parkinson's Victoria, Surrey Hills, Victoria, VIC, Australia.""}, {'ForeName': 'Felicity A', 'Initials': 'FA', 'LastName': 'Baker', 'Affiliation': 'Faculty of Fine Arts and Music, The University of Melbourne, Southbank, Victoria, VIC, Australia.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Noffs', 'Affiliation': 'Centre for Neuroscience of Speech, The University of Melbourne, Carlton, Victoria, VIC, Australia.'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Vogel', 'Affiliation': 'Centre for Neuroscience of Speech, The University of Melbourne, Carlton, Victoria, VIC, Australia.'}]",Journal of Parkinson's disease,['10.3233/JPD-191838']
2124,32538880,Efficacy of osteopathic manipulative treatment on postural control in Parkinsonian patients with Pisa syndrome: A pilot randomized placebo-controlled trial.,"BACKGROUND


Pisa syndrome (PS) is a clinical condition frequently associated with Parkinson's Disease (PD). It is characterized by a trunk lateral flexion higher than 10 degrees and reversible when lying. One pathophysiological hypothesis is the altered verticality perception, due to a somatosensory impairment. Osteopathic Manipulative Treatment (OMT) manages fascial-system alterations, linked to somatic dysfunctions. Fascial system showed to be implicated in proprioceptive sensibility.
OBJECTIVE


The aim of the study was to assess OMT efficacy on postural control in PD-PS patients by stabilometry.
METHODS


In this single-blinded trial we studied 24 PD-PS patients, 12 of whom were randomly assigned to receive a multidisciplinary physical therapy protocol (MIRT) and sham OMT, while the other 12 received four OMT plus MIRT, along one month. The primary endpoint was the eye closed sway area assessment after the intervention. Evaluation of trunk lateral flexion (TLF) with DIERS formetrics was also performed.
RESULTS


At one month, the sway area of the OMT group significantly decreased compared to placebo (mean delta OMT - 326.00±491.24 mm2, p = 0.01). In the experimental group TLF showed a mean inclination reduction of 3.33 degrees after treatment (p = 0.044, mean d = 0.54). Moreover, a significant positive association between delta ECSA and delta TLF was observed (p = 0.04, r = 0.46).
DISCUSSION


Among PD-PS patients, MIRT plus OMT showed preliminary evidence of postural control and TLF improvement, compared to the control group.",2020,"At one month, the sway area of the OMT group significantly decreased compared to placebo (mean delta OMT - 326.00±491.24 mm2, p = 0.01).","['Parkinsonian patients with Pisa syndrome', 'PD-PS patients by stabilometry', '24 PD-PS patients']","['placebo', 'trunk lateral flexion (TLF', 'Osteopathic Manipulative Treatment (OMT', 'osteopathic manipulative treatment', 'multidisciplinary physical therapy protocol (MIRT) and sham OMT, while the other 12 received four OMT plus MIRT']","['mean inclination reduction', 'eye closed sway area assessment', 'OMT efficacy', 'proprioceptive sensibility', 'postural control and TLF improvement', 'delta ECSA and delta TLF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0920233', 'cui_str': 'Pisa syndrome'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0439791', 'cui_str': 'Lateral flexion'}, {'cui': 'C0949744', 'cui_str': 'Osteopathic manipulation'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0949744', 'cui_str': 'Osteopathic manipulation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439823', 'cui_str': 'Sensibilities'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0439791', 'cui_str': 'Lateral flexion'}, {'cui': 'C0439097', 'cui_str': 'Delta'}]",24.0,0.0908228,"At one month, the sway area of the OMT group significantly decreased compared to placebo (mean delta OMT - 326.00±491.24 mm2, p = 0.01).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zarucchi', 'Affiliation': 'Department of Brain Injury and Parkinson\'s Disease Rehabilitation, Ospedale ""Moriggia-Pelascini"", Gravedona ed Uniti, Como, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Vismara', 'Affiliation': 'PhD Programme in Experimental Medicine and Therapy, University di Turin, Turin, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Frazzitta', 'Affiliation': 'Department of Brain Injury and Parkinson\'s Disease Rehabilitation, Ospedale ""Moriggia-Pelascini"", Gravedona ed Uniti, Como, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mauro', 'Affiliation': 'Division of Neurology and Neurorehabilitation - IRCCS Istituto Auxologico Italiano, Piancavallo-Verbania, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Priano', 'Affiliation': 'Division of Neurology and Neurorehabilitation - IRCCS Istituto Auxologico Italiano, Piancavallo-Verbania, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Maestri', 'Affiliation': 'Department of Biomedical Engineering, Istituti Clinici Scientifici Maugeri Spa Società Benefit, IRCCS, Montescano, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bergna', 'Affiliation': 'Department of Clinical Research, SOMA Istituto Osteopatia, Milan, Italy.'}, {'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Tarantino', 'Affiliation': 'Department of Clinical Research, SOMA Istituto Osteopatia, Milan, Italy.'}]",NeuroRehabilitation,['10.3233/NRE-203068']
2125,32538882,"Effects of innovative hip-knee-ankle interlimb coordinated robot training on ambulation, cardiopulmonary function, depression, and fall confidence in acute hemiplegia.","BACKGROUND


While Walkbot-assisted locomotor training (WLT) provided ample evidence on balance and gait improvements, the therapeutic effects on cardiopulmonary and psychological elements as well as fall confidence are unknown in stroke survivors.
OBJECTIVE


The present study aimed to compare the effects of Walkbot locomotor training (WLT) with conventional locomotor training (CLT) on balance and gait, cardiopulmonary and psychological functions and fall confidence in acute hemiparetic stroke.
METHODS


Fourteen patients with acute hemiparetic stroke were randomized into either the WLT (60-minute physical therapy +30-minute Walkbot-assisted gait training) or CLT (60 min physical therapy +30 min gait training) groups, 7 days/week over 2 weeks. Clinical outcomes included the Berg balance scale (BBS), functional ambulation category (FAC), heart rate (HR) and Borg rating of perceived exertion (BRPE), Beck depression inventory-II (BDI-II), and the activities-specific balance confidence (ABC) scale. The analysis of covariance (ANCOVA) was conducted at P <  0.05.
RESULTS


ANCOVA showed that WLT showed superior effects, compared to CLT, on FAC, HR, BRPE, BDI-II, and ABC scale (P <  0.05), but not on BBS (P = 0.061).
CONCLUSIONS


Our results provide novel, promising clinical evidence that WLT improved balance and gait function as well as cardiopulmonary and psychological functions, and fall confidence in acute stroke survivors who were unable to ambulate independently.",2020,"RESULTS


ANCOVA showed that WLT showed superior effects, compared to CLT, on FAC, HR, BRPE, BDI-II, and ABC scale (P <  0.05), but not on BBS (P = 0.061).
","['acute hemiparetic stroke', 'Fourteen patients with acute hemiparetic stroke', 'acute hemiplegia', 'acute stroke survivors']","['Walkbot locomotor training (WLT) with conventional locomotor training (CLT', 'WLT (60-minute physical therapy +30-minute Walkbot-assisted gait training) or CLT (60\u200amin physical therapy +30\u200amin gait training', 'innovative hip-knee-ankle interlimb coordinated robot training', 'While Walkbot-assisted locomotor training (WLT', 'WLT']","['ambulation, cardiopulmonary function, depression, and fall confidence', 'balance and gait function', 'BBS', 'Berg balance scale (BBS), functional ambulation category (FAC), heart rate (HR) and Borg rating of perceived exertion (BRPE), Beck depression inventory-II (BDI-II), and the activities-specific balance confidence (ABC) scale', 'FAC, HR, BRPE, BDI-II, and ABC scale', 'balance and gait, cardiopulmonary and psychological functions and fall confidence']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0419113', 'cui_str': 'Locomotor training'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2733457', 'cui_str': 'Activities specific balance confidence scale'}, {'cui': 'C0233398', 'cui_str': 'Psychological function'}]",14.0,0.02254,"RESULTS


ANCOVA showed that WLT showed superior effects, compared to CLT, on FAC, HR, BRPE, BDI-II, and ABC scale (P <  0.05), but not on BBS (P = 0.061).
","[{'ForeName': 'Chanhee', 'Initials': 'C', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, Sports Movement Artificial-Intelligence Robotics Technology (SMART) Institute, Yonsei University, Wonju, Republic of Korea.'}, {'ForeName': 'Mooyeon', 'Initials': 'M', 'LastName': 'Oh-Park', 'Affiliation': 'Burke Rehabilitation Hospital, White Plains, NY, USA.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Dohle', 'Affiliation': 'Burke Rehabilitation Hospital, White Plains, NY, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Bialek', 'Affiliation': 'Burke Neurological Institute, White Plains, NY, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Friel', 'Affiliation': 'Burke Neurological Institute, White Plains, NY, USA.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Edwards', 'Affiliation': 'Moss Rehabilitation, Philadelphia, PA, USA.'}, {'ForeName': 'Hermano Igo', 'Initials': 'HI', 'LastName': 'Krebs', 'Affiliation': 'Massachusetts Institute of Technology, Cambridge, MA, USA.'}, {'ForeName': 'Joshua Sung H', 'Initials': 'JSH', 'LastName': 'You', 'Affiliation': 'Department of Physical Therapy, Sports Movement Artificial-Intelligence Robotics Technology (SMART) Institute, Yonsei University, Wonju, Republic of Korea.'}]",NeuroRehabilitation,['10.3233/NRE-203086']
2126,32538889,Biofeedback flutter device for managing the symptoms of patients with COPD.,"BACKGROUND


Flutter is a device used in removing excess lung secretions. The conventional flutter lacks a biofeedback component to facilitate optimal use by the patients.
OBJECTIVE


The current research aims to compare the effects of biofeedback flutter devices with the conventional flutter in managing the symptoms of patients with chronic obstructive pulmonary diseases.
METHODS


One hundred and sixty-eight participants were randomly allocated into four groups: Group A (conventional), Group B (visual biofeedback), Group C (auditory biofeedback) and Group D (visual and auditory biofeedback). All groups were treated five days for 20 minutes. Outcome measures included wet sputum weight [during intervention (T1) and 1 hour after intervention (T2)], oxygen saturation and dyspnea score (before and after intervention) on all days.
RESULTS


The wet sputum expectorated (T2) by Group B was significantly higher than Group A (P< 0.001), Group C (P< 0.001) and Group D (P< 0.05). The dyspnea score for Group B (P< 0.05), Group C (P< 0.05) and Group D (P< 0.05) was significantly lower than Group A. The post-intervention oxygen saturation level was higher in Group D followed by Groups B, C and A.
CONCLUSION


The use of biofeedback flutter is effective in the removal of secretion, reducing dyspnea and improving oxygen saturation when compared to conventional flutter.",2020,"The dyspnea score for Group B (P< 0.05), Group C (P< 0.05) and Group D (P< 0.05) was significantly lower than Group A.","['patients with COPD', 'patients with chronic obstructive pulmonary diseases', 'One hundred and sixty-eight participants']","['Group A (conventional), Group B (visual biofeedback), Group C (auditory biofeedback) and Group D (visual and auditory biofeedback', 'biofeedback flutter devices', 'Biofeedback flutter device']","['post-intervention oxygen saturation level', 'dyspnea score', 'dyspnea and improving oxygen saturation', 'wet sputum weight [during intervention (T1) and 1 hour after intervention (T2)], oxygen saturation and dyspnea score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C4319556', 'cui_str': '168'}]","[{'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0441838', 'cui_str': 'Group D'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439227', 'cui_str': 'hour'}]",168.0,0.0192565,"The dyspnea score for Group B (P< 0.05), Group C (P< 0.05) and Group D (P< 0.05) was significantly lower than Group A.","[{'ForeName': 'Rekha', 'Initials': 'R', 'LastName': 'Kaja', 'Affiliation': 'Saveetha College of Physiotherapy, Saveetha University, Chennai, India.'}, {'ForeName': 'Anandh', 'Initials': 'A', 'LastName': 'Vaiyapuri', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Majmaah University, Majmaah, Saudi Arabia.'}, {'ForeName': 'Mohamed Sherif', 'Initials': 'MS', 'LastName': 'Sirajudeen', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Majmaah University, Majmaah, Saudi Arabia.'}, {'ForeName': 'Hariraja', 'Initials': 'H', 'LastName': 'Muthusamy', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Majmaah University, Majmaah, Saudi Arabia.'}, {'ForeName': 'Radhakrishnan', 'Initials': 'R', 'LastName': 'Unnikrishnan', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Majmaah University, Majmaah, Saudi Arabia.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Waly', 'Affiliation': 'Department of Medical Equipment Technology, College of Applied Medical Sciences, Majmaah University, Majmaah, Saudi Arabia.'}, {'ForeName': 'Samuel Sundar Doss', 'Initials': 'SSD', 'LastName': 'Devaraj', 'Affiliation': 'Saveetha Medical College, Saveetha University, Chennai, India.'}, {'ForeName': 'Mohamed Kotb', 'Initials': 'MK', 'LastName': 'Seyam', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Majmaah University, Majmaah, Saudi Arabia.'}, {'ForeName': 'Gopal Nambi', 'Initials': 'GN', 'LastName': 'S', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdul Aziz University, Alkharj, Saudi Arabia.'}]",Technology and health care : official journal of the European Society for Engineering and Medicine,['10.3233/THC-202222']
2127,32539079,Hookworm Treatment for Relapsing Multiple Sclerosis: A Randomized Double-Blinded Placebo-Controlled Trial.,"Importance


Studies suggest gut worms induce immune responses that can protect against multiple sclerosis (MS). To our knowledge, there are no controlled treatment trials with helminth in MS.
Objective


To determine whether hookworm treatment has effects on magnetic resonance imaging (MRI) activity and T regulatory cells in relapsing MS.
Design, Setting, and Participants


This 9-month double-blind, randomized, placebo-controlled trial was conducted between September 2012 and March 2016 in a modified intention-to-treat population (the data were analyzed June 2018) at the University of Nottingham, Queen's Medical Centre, a single tertiary referral center. Patients aged 18 to 61 years with relapsing MS without disease-modifying treatment were recruited from the MS clinic. Seventy-three patients were screened; of these, 71 were recruited (2 ineligible/declined).
Interventions


Patients were randomized (1:1) to receive either 25 Necator americanus larvae transcutaneously or placebo. The MRI scans were performed monthly during months 3 to 9 and 3 months posttreatment.
Main Outcomes and Measures


The primary end point was the cumulative number of new/enlarging T2/new enhancing T1 lesions at month 9. The secondary end point was the percentage of cluster of differentiation (CD) 4+CD25highCD127negT regulatory cells in peripheral blood.
Results


Patients (mean [SD] age, 45 [9.5] years; 50 women [71%]) were randomized to receive hookworm (35 [49.3%]) or placebo (36 [50.7%]). Sixty-six patients (93.0%) completed the trial. The median cumulative numbers of new/enlarging/enhancing lesions were not significantly different between the groups by preplanned Mann-Whitney U tests, which lose power with tied data (high number of zeroactivity MRIs in the hookworm group, 18/35 [51.4%] vs 10/36 [27.8%] in the placebo group). The percentage of CD4+CD25highCD127negT cells increased at month 9 in the hookworm group (hookworm, 32 [4.4%]; placebo, 34 [3.9%]; P = .01). No patients withdrew because of adverse effects. There were no differences in adverse events between groups except more application-site skin discomfort in the hookworm group (82% vs 28%). There were 5 relapses (14.3%) in the hookworm group vs 11 (30.6%) receiving placebo.
Conclusions and Relevance


Treatment with hookworm was safe and well tolerated. The primary outcome did not reach significance, likely because of a low level of disease activity. Hookworm infection increased T regulatory cells, suggesting an immunobiological effect of hookworm. It appears that a living organism can precipitate immunoregulatory changes that may affect MS disease activity.
Trial Registration


ClinicalTrials.gov Identifier: NCT01470521.",2020,"The percentage of CD4+CD25highCD127negT cells increased at month 9 in the hookworm group (hookworm, 32 [4.4%]; placebo, 34 [3.9%]; P = .01).","['Sixty-six patients (93.0%) completed the trial', ""September 2012 and March 2016 in a modified intention-to-treat population (the data were analyzed June 2018) at the University of Nottingham, Queen's Medical Centre, a single tertiary referral center"", 'Patients aged 18 to 61 years with relapsing MS without disease-modifying treatment were recruited from the MS clinic', 'Seventy-three patients were screened; of these, 71 were recruited (2 ineligible/declined', 'Relapsing Multiple Sclerosis', 'Results\n\n\nPatients (mean [SD] age, 45 [9.5] years; 50 women [71']","['25 Necator americanus larvae transcutaneously or placebo', 'Placebo', 'Hookworm Treatment', 'placebo']","['low level of disease activity', 'Hookworm infection increased T regulatory cells', 'percentage of CD4+CD25highCD127negT cells', 'cumulative number of new/enlarging T2/new enhancing T1 lesions', 'application-site skin discomfort', 'magnetic resonance imaging (MRI) activity and T regulatory cells', 'adverse events', 'safe and well tolerated', 'median cumulative numbers of new/enlarging/enhancing lesions', 'adverse effects', 'percentage of cluster of differentiation (CD) 4+CD25highCD127negT regulatory cells in peripheral blood']","[{'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3839267', 'cui_str': 'Multiple sclerosis clinic'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0002826', 'cui_str': 'Necator americanus'}, {'cui': 'C0023047', 'cui_str': 'Larvae'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002830', 'cui_str': 'Superfamily ancylostomatoidea'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0019911', 'cui_str': 'Disease due to superfamily Ancylostomatoidea'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1267822', 'cui_str': 'T lymphocyte positive for both CD4 antigen and CD25 antigen'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0442800', 'cui_str': 'Enlarged'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0229986', 'cui_str': 'Application site'}, {'cui': 'C0863084', 'cui_str': 'Skin discomfort'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}]",73.0,0.688359,"The percentage of CD4+CD25highCD127negT cells increased at month 9 in the hookworm group (hookworm, 32 [4.4%]; placebo, 34 [3.9%]; P = .01).","[{'ForeName': 'Radu', 'Initials': 'R', 'LastName': 'Tanasescu', 'Affiliation': 'Division of Clinical Neuroscience, University of Nottingham, Nottingham, England.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Tench', 'Affiliation': 'Division of Clinical Neuroscience, University of Nottingham, Nottingham, England.'}, {'ForeName': 'Cris S', 'Initials': 'CS', 'LastName': 'Constantinescu', 'Affiliation': 'Division of Clinical Neuroscience, University of Nottingham, Nottingham, England.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Telford', 'Affiliation': 'Immune Regulation Research Group, University of Nottingham, Nottingham, England.'}, {'ForeName': 'Sonika', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Division of Clinical Neuroscience, University of Nottingham, Nottingham, England.'}, {'ForeName': 'Nanci', 'Initials': 'N', 'LastName': 'Frakich', 'Affiliation': 'Division of Clinical Neuroscience, University of Nottingham, Nottingham, England.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Onion', 'Affiliation': 'Flow Cytometry Facilities, School of Life Sciences, University of Nottingham, Nottingham, England.'}, {'ForeName': 'Dorothee P', 'Initials': 'DP', 'LastName': 'Auer', 'Affiliation': 'Division of Clinical Neuroscience, University of Nottingham, Nottingham, England.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Gran', 'Affiliation': 'Division of Clinical Neuroscience, University of Nottingham, Nottingham, England.'}, {'ForeName': 'Nikos', 'Initials': 'N', 'LastName': 'Evangelou', 'Affiliation': 'Division of Clinical Neuroscience, University of Nottingham, Nottingham, England.'}, {'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Falah', 'Affiliation': 'Division of Clinical Neuroscience, University of Nottingham, Nottingham, England.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Ranshaw', 'Affiliation': 'Immune Regulation Research Group, University of Nottingham, Nottingham, England.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Cantacessi', 'Affiliation': 'Department of Veterinary Medicine, University of Cambridge, Cambridge, England.'}, {'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Jenkins', 'Affiliation': 'Department of Veterinary Medicine, University of Cambridge, Cambridge, England.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Pritchard', 'Affiliation': 'Immune Regulation Research Group, University of Nottingham, Nottingham, England.'}]",JAMA neurology,['10.1001/jamaneurol.2020.1118']
2128,32539121,Effect of Nonintervention vs Oral Ibuprofen in Patent Ductus Arteriosus in Preterm Infants: A Randomized Clinical Trial.,"Importance


Persistent patent ductus arteriosus (PDA) in preterm infants is associated with increased mortality and respiratory morbidities, including bronchopulmonary dysplasia (BPD). Despite recent increasing use of noninterventional approaches, no study to our knowledge has yet directly compared the nonintervention vs pharmacologic treatment for mediating PDA closure for decreasing mortality and preventing BPD.
Objective


To determine the noninferiority of nonintervention vs oral ibuprofen treatment for PDA in decreasing BPD incidence or death in very preterm infants.
Design, Setting, and Participants


A randomized, double-blind, placebo-controlled, noninferiority clinical trial was conducted on preterm infants (gestational age [GA] 23-30 weeks) with hemodynamically significant PDA (ductal size >1.5 mm plus respiratory support) diagnosed between postnatal days 6 and 14. Participants included 383 infants screened between July 24, 2014, and March 15, 2019.
Interventions


Infants were stratified by GA and randomly assigned (1:1) to receive either oral ibuprofen (initial dose of 10 mg/kg followed by a 5-mg/kg dose after 24 hours and a second 5-mg/kg dose after 48 hours) or placebo.
Main Outcomes and Measures


The primary outcome was BPD or death; the secondary outcomes included major morbidities and ductal closure rates. Per-protocol analysis was used.
Results


Among 383 infants screened for participation, 146 infants were randomly assigned, with 72 in the nonintervention and 70 in the ibuprofen treatment group in the final analyses. The PDA closure rate at 1 week after randomization was significantly higher with ibuprofen (11 [34%]) than nonintervention (2 [7%]) in infants at GA 27 to 30 weeks (P = .007); however, the findings were not significant at GA 23 to 26 weeks (ibuprofen, 3 [8%] vs nonintervention, 1 [2%], P = .34). In addition, the ductal closure rates before hospital discharge (ibuprofen, 62 [89%] vs nonintervention, 59 [82%], P = .27) and device closure (ibuprofen, 2 [3%] vs nonintervention, 4 [6%], P = .40) were not significantly different between the 2 groups. The nonintervention approach was noninferior to ibuprofen treatment in terms of BPD incidence or death (nonintervention, 44%; ibuprofen, 50%; 95% CI, -0.11 to 0.22; noninferiority margin -0.2; P = .51). One infant in the ibuprofen arm received oral ibuprofen backup rescue treatment owing to cardiopulmonary compromise refractory to conservative management, and another infant in the ibuprofen group received surgical ligation; none of the infants in the placebo group received backup treatment.
Conclusions and Relevance


Nonintervention showed noninferiority compared with ibuprofen treatment in closing of hemodynamically significant PDA and reduction of BPD or death. The noninferiority of nonintervention over ibuprofen might be attributable to the low efficacy of oral ibuprofen for closing PDA, especially in infants born at 23 to 26 weeks' gestation.
Trial Registration


ClinicalTrials.gov Identifier: NCT02128191.",2020,"Conclusions and Relevance


Nonintervention showed noninferiority compared with ibuprofen treatment in closing of hemodynamically significant PDA and reduction of BPD or death.","['very preterm infants', 'Participants included 383 infants screened between July 24, 2014, and March 15, 2019', '383 infants screened for participation, 146 infants', 'preterm infants', ""infants born at 23 to 26 weeks' gestation"", 'Patent Ductus', 'Preterm Infants', 'preterm infants (gestational age [GA] 23-30 weeks) with hemodynamically significant PDA (ductal size >1.5 mm plus respiratory support) diagnosed between postnatal days 6 and 14']","['surgical ligation', 'Nonintervention vs Oral Ibuprofen', 'nonintervention vs oral ibuprofen', 'ibuprofen', 'oral ibuprofen', 'placebo']","['BPD or death', 'PDA closure rate', 'device closure', 'mortality and respiratory morbidities, including bronchopulmonary dysplasia (BPD', 'BPD incidence or death', 'major morbidities and ductal closure rates', 'ductal closure rates before hospital discharge']","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0030650', 'cui_str': 'Patents'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1301752', 'cui_str': 'Respiratory morbidity'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}]",,0.397656,"Conclusions and Relevance


Nonintervention showed noninferiority compared with ibuprofen treatment in closing of hemodynamically significant PDA and reduction of BPD or death.","[{'ForeName': 'Se In', 'Initials': 'SI', 'LastName': 'Sung', 'Affiliation': 'Samsung Medical Center, Department of Pediatrics, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Myung Hee', 'Initials': 'MH', 'LastName': 'Lee', 'Affiliation': 'Statistics and Data Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'So Yoon', 'Initials': 'SY', 'LastName': 'Ahn', 'Affiliation': 'Samsung Medical Center, Department of Pediatrics, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Yun Sil', 'Initials': 'YS', 'LastName': 'Chang', 'Affiliation': 'Samsung Medical Center, Department of Pediatrics, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Won Soon', 'Initials': 'WS', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Department of Pediatrics, Sungkyunkwan University School of Medicine, Seoul, Korea.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2020.1447']
2129,32539150,Effect of Telehealth Extended Care for Maintenance of Weight Loss in Rural US Communities: A Randomized Clinical Trial.,"Importance


Lifestyle interventions for obesity produce reductions in body weight that can decrease risk for diabetes and cardiovascular disease but are limited by suboptimal maintenance of lost weight and inadequate dissemination in low-resource communities.
Objective


To evaluate the effectiveness of extended care programs for obesity management delivered remotely in rural communities through the US Cooperative Extension System.
Design, Setting, and Participants


This randomized clinical trial was conducted from October 21, 2013, to December 21, 2018, in Cooperative Extension Service offices of 14 counties in Florida. A total of 851 individuals were screened for participation; 220 individuals did not meet eligibility criteria, and 103 individuals declined to participate. Of 528 individuals who initiated a 4-month lifestyle intervention, 445 qualified for randomization. Data were analyzed from August 22 to October 21, 2019.
Interventions


Participants were randomly assigned to extended care delivered via individual or group telephone counseling or an education control program delivered via email. All participants received 18 modules with posttreatment recommendations for maintaining lost weight. In the telephone-based interventions, health coaches provided participants with 18 individual or group sessions focused on problem solving for obstacles to the maintenance of weight loss.
Main Outcomes and Measures


The primary outcome was change in body weight from the conclusion of initial intervention (month 4) to final follow-up (month 22). An additional outcome was the proportion of participants achieving at least 10% body weight reduction at follow-up.
Results


Among 445 participants (mean [SD] age, 55.4 [10.2] years; 368 [82.7%] women; 329 [73.9%] white), 149 participants (33.5%) were randomized to individual telephone counseling, 143 participants (32.1%) were randomized to group telephone counseling, and 153 participants (34.4%) were randomized to the email education control. Mean (SD) baseline weight was 99.9 (14.6) kg, and mean (SD) weight loss after the initial intervention was 8.3 (4.9) kg. Mean weight regains at follow-up were 2.3 (95% credible interval [CrI], 1.2-3.4) kg in the individual telephone counseling group, 2.8 (95% CrI, 1.4-4.2) kg for the group telephone counseling group, and 4.1 (95% CrI, 3.1-5.0) kg for the education control group, with a significantly smaller weight regain observed in the individual telephone counseling group vs control group (posterior probability >.99). A larger proportion of participants in the individual telephone counseling group achieved at least 10% weight reductions (31.5% [95% CrI, 24.1%-40.0%]) than in the control group (19.1% [95% CrI, 14.1%-24.9%]) (posterior probability >.99).
Conclusions and Relevance


This randomized clinical trial found that providing extended care for obesity management in rural communities via individual telephone counseling decreased weight regain and increased the proportion of participants who sustained clinically meaningful weight losses.
Trial Registration


ClinicalTrials.gov Identifier: NCT02054624.",2020,"Interventions


Participants were randomly assigned to extended care delivered via individual or group telephone counseling or an education control program delivered via email.","['851 individuals were screened for participation; 220 individuals did not meet eligibility criteria, and 103 individuals declined to participate', 'Rural US Communities', 'rural communities', 'October 21, 2013, to December 21, 2018, in Cooperative Extension Service offices of 14 counties in Florida', '445 participants (mean [SD] age, 55.4 [10.2] years; 368 [82.7%] women; 329 [73.9%] white), 149 participants (33.5', '528 individuals who initiated a 4-month lifestyle intervention, 445 qualified for randomization', ' 143 participants (32.1%) were randomized to group telephone counseling, and 153 participants (34.4']","['individual telephone counseling', 'Telehealth Extended Care', 'extended care programs', 'email education control', 'extended care delivered via individual or group telephone counseling or an education control program delivered via email']","['proportion of participants achieving at least 10% body weight reduction', 'weight regain', 'change in body weight', 'Mean (SD) baseline weight', 'weight reductions', 'Mean weight regains', 'mean (SD) weight loss']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C1136454', 'cui_str': 'Refusal to Participate'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0016253', 'cui_str': 'Florida'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1303013', 'cui_str': 'Baseline weight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",851.0,0.131458,"Interventions


Participants were randomly assigned to extended care delivered via individual or group telephone counseling or an education control program delivered via email.","[{'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Perri', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville.'}, {'ForeName': 'Meena N', 'Initials': 'MN', 'LastName': 'Shankar', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Daniels', 'Affiliation': 'Department of Statistics, University of Florida, Gainesville.'}, {'ForeName': 'Patricia E', 'Initials': 'PE', 'LastName': 'Durning', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Ross', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville.'}, {'ForeName': 'Marian C', 'Initials': 'MC', 'LastName': 'Limacher', 'Affiliation': 'Department of Medicine, University of Florida, Gainesville.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Janicke', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville.'}, {'ForeName': 'A Daniel', 'Initials': 'AD', 'LastName': 'Martin', 'Affiliation': 'Department of Physical Therapy, University of Florida, Gainesville.'}, {'ForeName': 'Kumaresh', 'Initials': 'K', 'LastName': 'Dhara', 'Affiliation': 'Department of Statistics, University of Florida, Gainesville.'}, {'ForeName': 'Linda B', 'Initials': 'LB', 'LastName': 'Bobroff', 'Affiliation': 'Department of Family, Youth, and Community Sciences, University of Florida, Gainesville.'}, {'ForeName': 'Tiffany A', 'Initials': 'TA', 'LastName': 'Radcliff', 'Affiliation': 'Department of Health Policy and Management, Texas A&M University, College Station.'}, {'ForeName': 'Christie A', 'Initials': 'CA', 'LastName': 'Befort', 'Affiliation': 'Department of Population Health, University of Kansas Medical Center, Kansas City.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.6764']
2130,32539157,"A Randomized Clinical Trial Exploring Gambling Attitudes, Barriers to Treatment, and Efficacy of a Brief Motivational Intervention Among Ex-Offenders with Disordered Gambling.","Correctional populations are disproportionately burdened by disordered gambling; yet, problem awareness is minimal among both offenders and professionals within the criminal justice system. The aims of the current study were twofold: (i) to examine gambling attitudes and problem awareness among ex-offenders, and (ii) to determine the efficacy of a brief online gambling intervention for ex-offenders. Participants (N = 126) were ex-offenders on probation and parole. Gambling attitudes, attitudes toward treatment, and disorder gambling status were assessed. Disordered gamblers (n = 102) were randomly assigned to (i) a brief intervention plus referral to treatment or (ii) referral to treatment only, and these individuals were re-assessed at a 30-day follow-up. Lifetime disordered gambling was highly prevalent (86%) in the ex-offender sample, and providing information regarding disordered gambler status and referral to treatment was effective in decreasing gambling attitudes, as well as gambling severity and frequency. The current study has direct implications for treatment and intervention efforts among ex-offenders with disordered gambling and yields a greater understanding of attitudes toward gambling among ex-offenders.",2020,The current study has direct implications for treatment and intervention efforts among ex-offenders with disordered gambling and yields a greater understanding of attitudes toward gambling among ex-offenders.,"['Ex-Offenders with Disordered Gambling', 'ex-offenders', 'Disordered gamblers (n\xa0=\xa0102', 'Participants (N\xa0=\xa0126) were ex-offenders on probation and parole']","['brief intervention plus referral to treatment or (ii) referral to treatment only, and these individuals were re-assessed at a 30-day follow-up', 'online gambling intervention', 'Brief Motivational Intervention']","['gambling attitudes', 'Lifetime disordered gambling', 'Gambling attitudes, attitudes toward treatment, and disorder gambling status']","[{'cui': 'C0699726', 'cui_str': 'Offenders'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0858352', 'cui_str': 'Gambler'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0425169', 'cui_str': 'On probation'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}]","[{'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",126.0,0.0205525,The current study has direct implications for treatment and intervention efforts among ex-offenders with disordered gambling and yields a greater understanding of attitudes toward gambling among ex-offenders.,"[{'ForeName': 'Laura April', 'Initials': 'LA', 'LastName': 'Rosen', 'Affiliation': 'Department of Psychology, Saint Louis University, 3700 Lindell Blvd., Morrissey Hall, St. Louis, MO.'}, {'ForeName': 'Jeremiah', 'Initials': 'J', 'LastName': 'Weinstock', 'Affiliation': 'Department of Psychology, Saint Louis University, 3700 Lindell Blvd., Morrissey Hall, St. Louis, MO.'}, {'ForeName': 'Samuel Cody', 'Initials': 'SC', 'LastName': 'Peter', 'Affiliation': 'Department of Psychology, The University of Memphis, 400 Innovation Dr., Memphis, TN, 38111.'}]",Journal of forensic sciences,['10.1111/1556-4029.14476']
2131,32539204,The efficacy of macro-focused ultrasound in the treatment of upper facial laxity: A pilot study.,"BACKGROUND


Recently, macro-focused ultrasound (MFU) has become a popular non-invasive aesthetic treatment for facial laxity. However, there are no studies done that evaluated the use of MFU with a 2.0 mm transducer for upper facial lifting.
OBJECTIVES


To evaluate the efficacy and safety of MFU with a 2.0 mm transducer in the treatment of upper facial laxity in Thai patients.
METHODS


This was a prospective, evaluator-blinded pilot study with 34 Thai patients diagnosed with mild to moderate facial laxity. Patients were treated with a single session of MFU with 2.0 mm transducer at the forehead, lateral and just below the eye area. Primary outcome was the clinical improvement of upper facial laxity graded by 2 blinded dermatologists at baseline, 1-week, 1-, 3- and 6-month follow-up. Objective measurements including eyebrow height, upper facial volume and textural irregularities were evaluated. Patients' self-assessment scores and adverse effects were also recorded.
RESULTS


Out of 34 patients, 27 (79.4%) attended all follow-ups. Clinical improvement of upper facial laxity was observed as early as 1-week follow-up. Eyebrow height elevation was significantly increased at every follow-up (p=0.000) with an average of 1.22 mm at 6-month follow-up. Wrinkles improved significantly at 1-week and 6-month follow-up (p=0.002 and p=0.010, respectively). Skin roughness showed significant improvement at 6-month follow-up (p=0.004). Majority of the patients (53.6%) reported marked improvement at 3-month follow-up. No serious adverse event was noted.
CONCLUSION


MFU is a safe and effective treatment for upper facial laxity and skin textural irregularities in patients with mild to moderate degree of laxity.",2020,"Wrinkles improved significantly at 1-week and 6-month follow-up (p=0.002 and p=0.010, respectively).","['upper facial laxity in Thai patients', '34 Thai patients diagnosed with mild to moderate facial laxity', 'upper facial laxity', 'Out of 34 patients, 27 (79.4%) attended all follow-ups', 'patients with mild to moderate degree of laxity']","['macro-focused ultrasound', 'macro-focused ultrasound (MFU', 'MFU']","['clinical improvement of upper facial laxity graded by 2 blinded dermatologists', 'upper facial laxity', ""Patients' self-assessment scores and adverse effects"", 'Wrinkles', 'efficacy and safety', 'Skin roughness', 'Eyebrow height elevation', 'eyebrow height, upper facial volume and textural irregularities']","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0332536', 'cui_str': 'Laxity'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0332536', 'cui_str': 'Laxity'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0259831', 'cui_str': 'Dermatologist'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0859038', 'cui_str': 'Skin roughness'}, {'cui': 'C0015420', 'cui_str': 'Eyebrow structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",34.0,0.027383,"Wrinkles improved significantly at 1-week and 6-month follow-up (p=0.002 and p=0.010, respectively).","[{'ForeName': 'Rungsima', 'Initials': 'R', 'LastName': 'Wanitphakdeedecha', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Chadakan', 'Initials': 'C', 'LastName': 'Yan', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Natasha C Ng', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'D P D S', 'Initials': 'DPDS', 'LastName': 'Ya-Nin Nokdhes', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Ploypailin', 'Initials': 'P', 'LastName': 'Tantrapornpong', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Thanya', 'Initials': 'T', 'LastName': 'Techapichetvanich', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sasima', 'Initials': 'S', 'LastName': 'Eimpunth', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Woraphong', 'Initials': 'W', 'LastName': 'Manuskiatti', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13550']
2132,32539224,Efficacy and safety of sodium-glucose co-transporter 2 inhibition according to left ventricular ejection fraction in DAPA-HF.,"AIMS


The aim of this study was to examine whether left ventricular ejection fraction (LVEF) modified efficacy and safety of dapagliflozin 10 mg compared with placebo in the 4744 patients with LVEF ≤40% randomized in the Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure trial (DAPA-HF).
METHODS AND RESULTS


We examined whether LVEF, analysed categorically or continuously, modified the effect of dapagliflozin. The primary efficacy outcome was the composite of a worsening heart failure (HF) event (unplanned HF hospitalization/an urgent HF visit requiring intravenous therapy) or cardiovascular death. Mean LVEF was 31.1% and LVEF categories analysed were: <26% (n = 1143), 26-30% (n = 1018), 31-35% (n = 1187), and >35% (n = 1396). Each 5% decrease in LVEF was associated with a higher risk of the primary outcome [hazard ratio (HR) 1.18; 95% confidence interval (CI) 1.13-1.24]. The benefit of dapagliflozin was consistent across the spectrum of LVEF: the dapagliflozin vs. placebo HR was 0.75 (95% CI 0.59-0.95) for LVEF <26%, 0.75 (0.57-0.98) for LVEF 26-30%, 0.67 (0.51-0.89) for LVEF 31-35%, and 0.83 (0.63-1.09) for LVEF >35% (P for interaction = 0.762). Similarly, the effect of dapagliflozin on the components of the primary endpoint was not modified by baseline LVEF (P for interaction for cardiovascular death = 0.974, and for worsening HF = 0.161). Safety of dapagliflozin was also consistent across the range of LVEF and neither efficacy nor safety were modified by diabetes status.
CONCLUSION


Left ventricular ejection fraction was a significant predictor of hospitalization and mortality in patients with HF with reduced ejection fraction but did not modify the beneficial effect of dapagliflozin, overall or separately, in patients with and without diabetes.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov Identifier NCT03036124.",2020,"Safety of dapagliflozin was also consistent across the range of LVEF and neither efficacy nor safety were modified by diabetes status.
",['4744 patients with LVEF\u2009≤40% randomized in the Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure trial (DAPA-HF'],"['sodium-glucose co-transporter 2 inhibition', 'dapagliflozin', 'LVEF', 'left ventricular ejection fraction (LVEF', 'placebo']","['hospitalization and mortality', 'LVEF', 'Mean LVEF', 'composite of a worsening heart failure (HF) event (unplanned HF hospitalization/an urgent HF visit requiring intravenous therapy) or cardiovascular death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0455142', 'cui_str': 'Intravenous therapy'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",4744.0,0.309689,"Safety of dapagliflozin was also consistent across the range of LVEF and neither efficacy nor safety were modified by diabetes status.
","[{'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Dewan', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Martinez', 'Affiliation': 'National University of Cordoba, Cordoba, Argentina.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'DeMets', 'Affiliation': 'Department of Biostatistics & Medical Informatics, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Bengtsson', 'Affiliation': 'AstraZeneca R&D, Gothenburg, Sweden.'}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Sjöstrand', 'Affiliation': 'AstraZeneca R&D, Gothenburg, Sweden.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'AstraZeneca R&D, Gothenburg, Sweden.'}, {'ForeName': 'Inder S', 'Initials': 'IS', 'LastName': 'Anand', 'Affiliation': 'VA Medical Center, University of Minnesota, MN, USA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Bělohlávek', 'Affiliation': '2nd Department of Internal Medicine, Cardiovascular Medicine, General University Hospital, Charles University in Prague, Czech Republic.'}, {'ForeName': 'Vijay K', 'Initials': 'VK', 'LastName': 'Chopra', 'Affiliation': 'Department of Cardiology, Max Super Specialty Hospital, New Delhi, India.'}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Dukát', 'Affiliation': 'Department of Internal Medicine, Comenius University in Bratislava, Bratislava, Slovakia.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Kitakaze', 'Affiliation': 'Cardiovascular Division of Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Béla', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Heart and Vascular Center, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': ""O'Meara"", 'Affiliation': 'Montreal Heart Institute and Université de Montreal, Montreal, Canada.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Schou', 'Affiliation': 'Department of Clinical Medicine, Herlev-Gentofte Hospital, Herlev, Denmark.'}, {'ForeName': 'Pham Nguyen', 'Initials': 'PN', 'LastName': 'Vinh', 'Affiliation': 'Department of Internal Medicine, Tan Tao University, Tan Duc city, Vietnam.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of heart failure,['10.1002/ejhf.1867']
2133,32539235,Effectiveness of a life story intervention for adults with intellectual disability and depressive and trauma-related complaints.,"INTRODUCTION


People with intellectual disability have a higher chance of developing mental disorders than the general population. Yet, few evidence-based interventions exist. This article evaluates My Lifestory, a narrative intervention tailored to people with intellectual disability and depressive or trauma-related complaints.
METHOD


A quasi-experimental research design was adopted with an experimental condition (My Lifestory) and a matched control condition (care as usual). Measurements took place before the intervention, at the end of the intervention and at follow-up two months later. Measurements focused on psychiatric complaints, well-being, life satisfaction, mastery, and purpose in life.
RESULTS


Participants in the intervention condition improved more in psychiatric complaints, well-being, life satisfaction, and purpose in life, but not in mastery, than participants in the control condition. Effect sizes were large in the intervention condition and small in the control condition.
DISCUSSION


Despite some limitations, this study adds to the evidence base of this narrative intervention.",2020,"RESULTS


Participants in the intervention condition improved more in psychiatric complaints, well-being, life satisfaction, and purpose in life, but not in mastery, than participants in the control condition.","['people with intellectual disability and depressive or trauma-related complaints', 'adults with intellectual disability and depressive and trauma-related complaints', 'People with intellectual disability']",['life story intervention'],"['psychiatric complaints, well-being, life satisfaction, and purpose in life', 'psychiatric complaints, well-being, life satisfaction, mastery, and purpose in life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}]",,0.0387123,"RESULTS


Participants in the intervention condition improved more in psychiatric complaints, well-being, life satisfaction, and purpose in life, but not in mastery, than participants in the control condition.","[{'ForeName': 'Janny', 'Initials': 'J', 'LastName': 'Beernink', 'Affiliation': 'Dokter Bosman Mental Health Care, Doetinchem, The Netherlands.'}, {'ForeName': 'Gerben J', 'Initials': 'GJ', 'LastName': 'Westerhof', 'Affiliation': 'Psychology, Health, and Technology, University of Twente, Enschede, The Netherlands.'}]",Journal of applied research in intellectual disabilities : JARID,['10.1111/jar.12754']
2134,32539288,Intracellular Tenofovir-Diphosphate and Emtricitabine-Triphosphate in Dried Blood Spots Following Tenofovir Alafenamide: The TAF-DBS Study.,"BACKGROUND


Tenofovir alafenamide (TAF), in combination with FTC, was recently approved for PrEP in the United States. The objective of this study was to assess the relationship between tenofovir-diphosphate (TFV-DP) and emtricitabine-triphosphate (FTC-TP) in dried blood spots (DBS) with adherence to TAF/FTC.
METHODS


TAF-DBS was a randomized, crossover clinical study of TFV-DP in DBS, following directly observed dosing of 33%, 67%, or 100% of daily TAF (25 mg)/FTC (200 mg). Healthy volunteers were randomized to 2 different, 12-week dosing regimens, separated by a 12-week washout. DBS were collected weekly. TFV-DP and FTC-TP were extracted from two 7-mm punches and assayed with LC-MS/MS.
RESULTS


Thirty-seven participants (17 female, 7 African American, and 6 Hispanic) were included. TFV-DP exhibited a mean half-life of 20.8 days (95% confidence interval: 19.3 to 21.3). The slope for TFV-DP versus dosing arm was 1.14 (90% confidence interval: 1.07 to 1.21). The mean (SD) TFV-DP after 12 weeks was 657 (186), 1451 (501), and 2381 (601) fmol/2 7-mm punches for the 33%, 67%, and 100% arms. The following adherence interpretations are proposed: <450 fmol/punches, <2 doses/wk; 450-949 fmol/punches, 2-3 doses/wk; 950-1799 fmol/punches, 4-6 doses/wk; and ≥1800 fmol/punches, 7 doses/wk. FTC-TP was quantifiable for 1 week after drug cessation in 50%, 92%, and 100% of participants in the 33%, 67%, and 100% arms, respectively.
CONCLUSION


TFV-DP in DBS after TAF/FTC exhibited a long half-life and was linearly associated with dosing, similar to its predecessor tenofovir disoproxil fumarate. FTC-TP was quantifiable for up to 1 week after drug cessation. Together, these moieties provide complementary measures of cumulative adherence and recent dosing for TAF/FTC.",2020,The slope for TFV-DP versus dosing arm was 1.14 (90% confidence interval: 1.07 to 1.21).,"['Thirty-seven participants (17 female, 7 African American, and 6 Hispanic', 'Healthy volunteers', 'TAF-DBS']","['tenofovir-diphosphate (TFV-DP) and emtricitabine-triphosphate (FTC-TP', 'Intracellular Tenofovir-Diphosphate and Emtricitabine-Triphosphate in Dried Blood Spots', 'TFV-DP', 'TAF', 'Tenofovir Alafenamide', 'Tenofovir alafenamide (TAF', 'tenofovir disoproxil fumarate']","['FTC-TP', 'TFV-DP and FTC-TP']","[{'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3713958', 'cui_str': 'tenofovir alafenamide'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}]","[{'cui': 'C3712637', 'cui_str': 'tenofovir diphosphate'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0077289', 'cui_str': 'tris(chloroethyl)phosphate'}, {'cui': 'C0206682', 'cui_str': 'Follicular thyroid carcinoma'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C3713958', 'cui_str': 'tenofovir alafenamide'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}]","[{'cui': 'C0206682', 'cui_str': 'Follicular thyroid carcinoma'}, {'cui': 'C3712637', 'cui_str': 'tenofovir diphosphate'}]",,0.0794846,The slope for TFV-DP versus dosing arm was 1.14 (90% confidence interval: 1.07 to 1.21).,"[{'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Yager', 'Affiliation': 'Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Castillo-Mancilla', 'Affiliation': 'Division of Infectious Diseases, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Mustafa E', 'Initials': 'ME', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Brooks', 'Affiliation': 'Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Cricket', 'Initials': 'C', 'LastName': 'McHugh', 'Affiliation': 'Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Morrow', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Colorado School of Public Health, Aurora, CO.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'McCallister', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'Lane R', 'Initials': 'LR', 'LastName': 'Bushman', 'Affiliation': 'Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'MaWhinney', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Colorado School of Public Health, Aurora, CO.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Kiser', 'Affiliation': 'Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Anderson', 'Affiliation': 'Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, CO.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002354']
2135,32539432,The Effects of an Online Training on Preservice Speech-Language Pathologists' Use of Family-Centered Skills.,"Purpose Despite the recognition that family-centered services are best practice in augmentative and alternative communication services, many speech-language pathologists (SLPs) are lacking in their acquisition and implementation of family-centered skills. The purpose of this study was to evaluate the effects of online instruction in a family-centered, relational skills strategy on preservice SLPs use of family-centered skills. Method A switching replications design was used to evaluate the effects of an online training on the use of family-centered behaviors by 15 preservice SLPs who were randomly assigned to two groups. The online training taught the students a four-step relational skills strategy (summarized by the acronym LAFF): (a) Listen, empathize, and communicate respect; (b) Ask questions; (c) Focus on the issues; and (d) Find a first step. Participants were videotaped during interactions with simulated parents before and after the training. Results After an average of 61 min of instruction via the online module, all of the preservice SLPs significantly improved their demonstration of relational skills. Additionally, one parent of a child who used augmentative and alternative communication viewed the video recordings and chose 14 of the 15 postinstruction role plays as more family-centered. Conclusion The findings from this study provide support for the use of an online environment to teach preservice SLPs family-centered relational skills. In order to prepare future SLPs and ensure the delivery of family-centered services, future research is necessary, including investigations to determine whether other family-centered skills can be effectively taught through an online environment. Supplemental Material https://doi.org/10.23641/asha.12462344.",2020,"After an average of 61 min of instruction via the online module, all of the preservice SLPs significantly improved their demonstration of relational skills.","[""Preservice Speech-Language Pathologists' Use of Family-Centered Skills"", 'family-centered behaviors by 15 preservice SLPs']","['online instruction', 'online training', 'Supplemental Material https://doi.org/10.23641/asha.12462344', 'Online Training', 'online training taught the students a four-step relational skills strategy (summarized by the acronym LAFF): (a) Listen, empathize, and communicate respect']",['demonstration of relational skills'],"[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0334866', 'cui_str': 'Medical pathologist'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C1956259', 'cui_str': 'Acronyms'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0205196', 'cui_str': 'Communicating'}, {'cui': 'C0679133', 'cui_str': 'Respect'}]",[],,0.0160661,"After an average of 61 min of instruction via the online module, all of the preservice SLPs significantly improved their demonstration of relational skills.","[{'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Mandak', 'Affiliation': 'Department of Communication Sciences and Disorders, The Pennsylvania State University, State College.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Light', 'Affiliation': 'Department of Communication Sciences and Disorders, The Pennsylvania State University, State College.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'McNaughton', 'Affiliation': 'Department of Educational Psychology, Counseling, and Special Education, The Pennsylvania State University, State College.'}]",American journal of speech-language pathology,['10.1044/2020_AJSLP-19-00057']
2136,32539487,Cognition test battery: Adjusting for practice and stimulus set effects for varying administration intervals in high performing individuals.,"INTRODUCTION


Practice effects associated with the repeated administration of cognitive tests often confound true therapeutic or experimental effects. Alternate test forms help reduce practice effects, but generating stimulus sets with identical properties can be difficult. The main objective of this study was to disentangle practice and stimulus set effects for  Cognition , a battery of 10 brief cognitive tests specifically designed for high-performing populations with 15 unique versions for repeated testing. A secondary objective was to investigate the effects of test-retest interval on practice effects.
METHODS


The 15 versions of  Cognition  were administered in three groups of 15-16 subjects (total N = 46, mean±SD age 32.5 ± 7.2 years, range 25-54 years, 23 male) in a randomized but balanced fashion with administration intervals of ≥10 days, ≤5 days, or 4 times per day. Mixed effect models were used to investigate linear and logarithmic trends across repeated administrations in key speed and accuracy outcomes, whether these trends differed significantly between administration interval groups, and whether stimulus sets differed significantly in difficulty.
RESULTS


Protracted, non-linear practice effects well beyond the second administration were observed for most of the 10  Cognition  tests both in accuracy and speed, but test-retest administration interval significantly affected practice effects only for 3 out of the 10 tests and only in the speed domain. Stimulus set effects were observed for the 6  Cognition  tests that use unique sets of stimuli. Factors were established that allow for correcting for both practice and stimulus set effects.
CONCLUSIONS


Practice effects are pronounced and probably under-appreciated in cognitive testing. The correction factors established in this study are a unique feature of the  Cognition  battery that can help avoid masking practice effects, address noise generated by differences in stimulus set difficulty, and facilitate interpretation of results from studies with repeated assessments.",2020,"RESULTS


Protracted, non-linear practice effects well beyond the second administration were observed for most of the 10  Cognition  tests both in accuracy and speed, but test-retest administration interval significantly affected practice effects only for 3 out of the 10 tests and only in the speed domain.","['high-performing populations with 15 unique versions for repeated testing', '15 versions of  Cognition  were administered in three groups of 15-16 subjects (total N =\xa046, mean±SD age 32.5\xa0±\xa07.2\xa0years, range 25-54\xa0years, 23 male']",[],['Cognition test battery'],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517710', 'cui_str': '32.5'}, {'cui': 'C4517857', 'cui_str': '7.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0086582', 'cui_str': 'Male'}]",[],"[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}]",,0.0386009,"RESULTS


Protracted, non-linear practice effects well beyond the second administration were observed for most of the 10  Cognition  tests both in accuracy and speed, but test-retest administration interval significantly affected practice effects only for 3 out of the 10 tests and only in the speed domain.","[{'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Basner', 'Affiliation': 'Unit for Experimental Psychiatry, Division of Sleep and Chronobiology, Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania , Philadelphia, PA, USA.'}, {'ForeName': 'Emanuel', 'Initials': 'E', 'LastName': 'Hermosillo', 'Affiliation': 'Unit for Experimental Psychiatry, Division of Sleep and Chronobiology, Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania , Philadelphia, PA, USA.'}, {'ForeName': 'Jad', 'Initials': 'J', 'LastName': 'Nasrini', 'Affiliation': 'Unit for Experimental Psychiatry, Division of Sleep and Chronobiology, Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania , Philadelphia, PA, USA.'}, {'ForeName': 'Salil', 'Initials': 'S', 'LastName': 'Saxena', 'Affiliation': 'Unit for Experimental Psychiatry, Division of Sleep and Chronobiology, Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania , Philadelphia, PA, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Dinges', 'Affiliation': 'Unit for Experimental Psychiatry, Division of Sleep and Chronobiology, Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania , Philadelphia, PA, USA.'}, {'ForeName': 'Tyler M', 'Initials': 'TM', 'LastName': 'Moore', 'Affiliation': 'Brain Behavior Laboratory, Neuropsychiatry Section, Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania , Philadelphia, PA, USA.'}, {'ForeName': 'Ruben C', 'Initials': 'RC', 'LastName': 'Gur', 'Affiliation': 'Brain Behavior Laboratory, Neuropsychiatry Section, Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania , Philadelphia, PA, USA.'}]",Journal of clinical and experimental neuropsychology,['10.1080/13803395.2020.1773765']
2137,32539506,"In MRSA bacteremia, adding a β-lactam to usual care did not improve a composite outcome at 90 days.","SOURCE CITATION


Tong SY, Lye DC, Yahav D, et al.  Effect of vancomycin or daptomycin with vs without an antistaphylococcal β-lactam on mortality, bacteremia, relapse, or treatment failure in patients with MRSA bacteremia: a randomized clinical trial.  JAMA. 2020;323:527-37. 32044943.",2020,"Effect of vancomycin or daptomycin with vs without an antistaphylococcal β-lactam on mortality, bacteremia, relapse, or treatment failure in patients with MRSA bacteremia: a randomized clinical trial.  ",['patients with MRSA bacteremia'],['vancomycin or daptomycin'],"['mortality, bacteremia, relapse, or treatment failure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4040349', 'cui_str': 'Bacteremia due to Methicillin resistant Staphylococcus aureus'}]","[{'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0057144', 'cui_str': 'Daptomycin'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}]",,0.0665675,"Effect of vancomycin or daptomycin with vs without an antistaphylococcal β-lactam on mortality, bacteremia, relapse, or treatment failure in patients with MRSA bacteremia: a randomized clinical trial.  ","[{'ForeName': 'Eleftheria', 'Initials': 'E', 'LastName': 'Atalla', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, Rhode Island, USA (E.A., E.M.).'}, {'ForeName': 'Eleftherios', 'Initials': 'E', 'LastName': 'Mylonakis', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, Rhode Island, USA (E.A., E.M.).'}]",Annals of internal medicine,['10.7326/ACPJ202006160-067']
2138,32539520,"In COVID-19, adding lopinavir-ritonavir to usual care did not shorten time to clinical improvement.","SOURCE CITATION


Cao B, Wang Y, Wen D, et al.  A trial of lopinavir-ritonavir in adults hospitalized with severe Covid-19.  N Engl J Med. 2020;382:1787-99. 32187464.",2020,A trial of lopinavir-ritonavir in adults hospitalized with severe Covid-19.  ,['adults hospitalized with severe Covid-19'],['lopinavir-ritonavir'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}]",[],,0.0270717,A trial of lopinavir-ritonavir in adults hospitalized with severe Covid-19.  ,"[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Yang', 'Affiliation': 'Emory University, Atlanta, Georgia, USA (P.Y., S.T., G.S.M.).'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Tekwani', 'Affiliation': 'Emory University, Atlanta, Georgia, USA (P.Y., S.T., G.S.M.).'}, {'ForeName': 'Greg S', 'Initials': 'GS', 'LastName': 'Martin', 'Affiliation': 'Emory University, Atlanta, Georgia, USA (P.Y., S.T., G.S.M.).'}]",Annals of internal medicine,['10.7326/ACPJ202006160-063']
2139,32539588,The Impact of Interactive Shared Book Reading on Children's Language Skills: A Randomized Controlled Trial.,"Purpose Research has indicated that interactive shared book reading can support a wide range of early language skills and that children who are read to regularly in the early years learn language faster, enter school with a larger vocabulary, and become more successful readers at school. Despite the large volume of research suggesting interactive shared reading is beneficial for language development, two fundamental issues remain outstanding: whether shared book reading interventions are equally effective (a) for children from all socioeconomic backgrounds and (b) for a range of language skills. Method To address these issues, we conducted a randomized controlled trial to investigate the effects of two 6-week interactive shared reading interventions on a range of language skills in children across the socioeconomic spectrum. One hundred and fifty children aged between 2;6 and 3;0 (years;months) were randomly assigned to one of three conditions: a pause reading, a dialogic reading, or an active shared reading control condition. Results The findings indicated that the interventions were effective at changing caregiver reading behaviors. However, the interventions did not boost children's language skills over and above the effect of an active reading control condition. There were also no effects of socioeconomic status. Conclusion This randomized controlled trial showed that caregivers from all socioeconomic backgrounds successfully adopted an interactive shared reading style. However, while the interventions were effective at increasing caregivers' use of interactive shared book reading behaviors, this did not have a significant impact on the children's language skills. The findings are discussed in terms of practical implications and future research. Supplemental Material https://doi.org/10.23641/asha.12420539.",2020,"However, the interventions did not boost children's language skills over and above the effect of an active reading control condition.","['children across the socioeconomic spectrum', ""Children's Language Skills"", 'One hundred and fifty children aged between 2;6 and 3;0 (years;months']","['interactive shared reading interventions', 'Supplemental Material https://doi.org/10.23641/asha.12420539', 'Interactive Shared Book Reading', 'pause reading, a dialogic reading, or an active shared reading control condition']","[""children's language skills""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0008081', 'cui_str': 'Child Language'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0008081', 'cui_str': 'Child Language'}]",150.0,0.0973005,"However, the interventions did not boost children's language skills over and above the effect of an active reading control condition.","[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Noble', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, United Kingdom.'}, {'ForeName': 'Thea', 'Initials': 'T', 'LastName': 'Cameron-Faulkner', 'Affiliation': 'School of Arts, Languages and Cultures, The University of Manchester, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Jessop', 'Affiliation': 'Language Development Department, Max Planck Institute for Psycholinguistics, Nijmegen, the Netherlands.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Coates', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, United Kingdom.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Sawyer', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, United Kingdom.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Taylor-Ims', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, United Kingdom.'}, {'ForeName': 'Caroline F', 'Initials': 'CF', 'LastName': 'Rowland', 'Affiliation': 'Language Development Department, Max Planck Institute for Psycholinguistics, Nijmegen, the Netherlands.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2020_JSLHR-19-00288']
2140,32539655,Effects of a high-intensity psychosocial intervention among child-parent units in pediatric oncology.,"AIM


To compare the efficacy of a high-intensity psychosocial intervention with standardized usual care in countering psychosocial complexity among child-parent units in a pediatric oncology setting.
METHODS


Two hundred pediatric oncology patients and their parents were recruited from Italian hospitals. A total of 81 child-parent units were assigned to the high-intensity psychosocial intervention and 119 child-parent units to standardized usual care. Psychosocial factors were assessed before and 1 year after intervention to measure efficacy.
RESULTS


More improvements over time were observed in the high-intensity intervention group of child-parent units compared to the standard intervention group.
CONCLUSION


An intensive, structured, and tailored high-intensity intervention positively affects the psychosocial factors of child-parent units. Patients and families should have access to intensive psychosocial support throughout the cancer trajectory.",2020,"RESULTS


More improvements over time were observed in the high-intensity intervention group of child-parent units compared to the standard intervention group.
","['81 child-parent units', 'child-parent units in pediatric oncology', 'Two hundred pediatric oncology patients and their parents were recruited from Italian hospitals', 'child-parent units in a pediatric oncology setting']","['high-intensity psychosocial intervention', 'high-intensity psychosocial intervention with standardized usual care', 'high-intensity psychosocial intervention and 119 child-parent units to standardized usual care']",['Psychosocial factors'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C1518931', 'cui_str': 'Pediatric oncology'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}]",200.0,0.0358755,"RESULTS


More improvements over time were observed in the high-intensity intervention group of child-parent units compared to the standard intervention group.
","[{'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Zucchetti', 'Affiliation': 'Pediatric Oncology Division, Azienda Ospedaliera-Universitaria Città della Salute e della Scienza, Turin, Italy.'}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Ambrogio', 'Affiliation': 'Pediatric Division, ASL CN 1, Savigliano, Cuneo, Italy.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Bertolotti', 'Affiliation': 'Pediatric Oncology Division, Azienda Ospedaliera-Universitaria Città della Salute e della Scienza, Turin, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Besenzon', 'Affiliation': 'Pediatric Division, ASL CN 1, Savigliano, Cuneo, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Borghino', 'Affiliation': 'Pediatric Division, ASL CN 1, Savigliano, Cuneo, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Candela', 'Affiliation': 'University of Turin, Turin, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Galletto', 'Affiliation': 'Pediatric Division, ASL CN 1, Savigliano, Cuneo, Italy.'}, {'ForeName': 'Franca', 'Initials': 'F', 'LastName': 'Fagioli', 'Affiliation': 'Pediatric Oncology Division, Azienda Ospedaliera-Universitaria Città della Salute e della Scienza, Turin, Italy.'}]",Tumori,['10.1177/0300891620926226']
2141,32539711,"Older adults' preferences for, adherence to and experiences of two self-management falls prevention home exercise programmes: a comparison between a digital programme and a paper booklet.","BACKGROUND


Fall prevention exercise programmes are known to be effective, but access to these programmes is not always possible. The use of eHealth solutions might be a way forward to increase access and reach a wider population. In this feasibility study the aim was to explore the choice of programme, adherence, and self-reported experiences comparing two exercise programmes - a digital programme and a paper booklet.
METHODS


A participant preference trial of two self-managed fall prevention exercise interventions. Community-dwelling adults aged 70 years and older exercised independently for four months after one introduction meeting. Baseline information was collected at study start, including a short introduction of the exercise programme, a short physical assessment, and completion of questionnaires. During the four months intervention period, participants self-reported their performed exercises in an exercise diary. At a final meeting, questionnaires about their experiences, and post-assessments, were completed. For adherence analyses data from diaries were used and four subgroups for different levels of participation were compared. Exercise maintenance was followed up with a survey 12 months after study start.
RESULTS


Sixty-seven participants, with mean age 77 ± 4 years were included, 72% were women. Forty-three percent chose the digital programme. Attrition rate was 17% in the digital programme group and 37% in the paper booklet group (p = .078). In both groups 50-59% reported exercise at least 75% of the intervention period. The only significant difference for adherence was in the subgroup that completed ≥75% of exercise duration, the digital programme users exercised more minutes per week (p = .001). Participants in both groups were content with their programme but digital programme users reported a significantly higher (p = .026) degree of being content, and feeling supported by the programme (p = .044). At 12 months follow-up 67% of participants using the digital programme continued to exercise regularly compared with 35% for the paper booklet (p = .036).
CONCLUSIONS


Exercise interventions based on either a digital programme or a paper booklet can be used as a self-managed, independent fall prevention programme. There is a similar adherence in both programmes during a 4-month intervention, but the digital programme seems to facilitate long-term maintenance in regular exercise.
TRIAL REGISTRATION


ClinTrial: NCT02916849.",2020,"At 12 months follow-up 67% of participants using the digital programme continued to exercise regularly compared with 35% for the paper booklet (p = .036).
","['Community-dwelling adults aged 70\u2009years and older exercised independently for four months after one introduction meeting', 'Older adults', 'Sixty-seven participants, with mean age 77\u2009±\u20094\u2009years were included, 72% were women']","['self-managed fall prevention exercise interventions', 'exercise programmes - a digital programme and a paper booklet']","['adherence', 'Attrition rate']","[{'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}]",,0.043474,"At 12 months follow-up 67% of participants using the digital programme continued to exercise regularly compared with 35% for the paper booklet (p = .036).
","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Mansson', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Section of Physiotherapy, Umeå University, Umeå, Sweden. linda.mansson@umu.se.'}, {'ForeName': 'Lillemor', 'Initials': 'L', 'LastName': 'Lundin-Olsson', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Section of Physiotherapy, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Dawn A', 'Initials': 'DA', 'LastName': 'Skelton', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Rebecka', 'Initials': 'R', 'LastName': 'Janols', 'Affiliation': 'Department of Computing Science, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Lindgren', 'Affiliation': 'Department of Computing Science, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Rosendahl', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Section of Physiotherapy, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Sandlund', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Section of Physiotherapy, Umeå University, Umeå, Sweden.'}]",BMC geriatrics,['10.1186/s12877-020-01592-x']
2142,32512364,Intake of Camelina Sativa Oil and Fatty Fish Alter the Plasma Lipid Mediator Profile in Subjects with Impaired Glucose Metabolism - A Randomized Controlled Trial.,"n-3 and n-6 polyunsaturated fatty acids (PUFAs) and their lipid mediator metabolites are associated with inflammation. We investigated the effect of dietary intake of plant- and animal-derived n-3 PUFAs and fish protein on the circulatory concentrations of lipid mediators. Seventy-nine subjects with impaired fasting glucose who completed the controlled dietary intervention after randomization to the fatty fish (FF, n=20), lean fish (LF, n=21), Camelina sativa oil (CSO, n=18) or control group (n=20) for 12 weeks were studied. Lipid mediator profiling from fasting plasma samples before and after the intervention was performed by liquid chromatography-mass spectrometry (LC-MS/MS). The FF diet increased concentrations of 18-hydroxyeicosapentaenoic acid (18-HEPE) and 4- and 17-hydroxydocosahexaenoic acid (4-, 17-HDoHE) derived from eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), respectively. Concentrations of lipid mediators derived from α-linolenic acid (ALA) increased and arachidonic acid (AA) derived 5-iso prostaglandin F 2α -VI decreased in the CSO group. There were no significant changes in lipid mediators in the LF group. The dietary intake of both plant and animal-based n-3 PUFAs increased circulatory concentrations of lipid mediators with potential anti-inflammatory properties.",2020,The FF diet increased concentrations of 18-hydroxyeicosapentaenoic acid (18-HEPE) and,"['Subjects with Impaired Glucose Metabolism ', 'Seventy-nine subjects with impaired fasting glucose who completed the controlled dietary intervention after randomization to the fatty fish (FF, n=20), lean fish (LF, n=21']","['plant- and animal-derived n-3 PUFAs and fish protein', 'Camelina sativa oil (CSO, n=18) or control group', 'Camelina Sativa Oil and Fatty Fish', 'n-3 and n-6 polyunsaturated fatty acids (PUFAs', 'plant and animal-based n-3 PUFAs', '4- and 17-hydroxydocosahexaenoic acid (4-, 17-HDoHE) derived from eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA']","['lipid mediators', 'arachidonic acid (AA) derived 5-iso prostaglandin F 2α -VI', 'concentrations of 18-hydroxyeicosapentaenoic acid (18-HEPE', 'Plasma Lipid Mediator Profile']","[{'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0453017', 'cui_str': 'Fatty fish'}, {'cui': 'C0016163', 'cui_str': 'Fish'}]","[{'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0598294', 'cui_str': 'Fish Proteins'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0453017', 'cui_str': 'Fatty fish'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0639949', 'cui_str': '17-hydroxy-4,7,10,13,15,19-docosahexaenoic acid'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0033561', 'cui_str': 'F series prostaglandin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C3251952', 'cui_str': '18(R)-hydroxyeicosapentaenoic acid'}, {'cui': 'C0019215', 'cui_str': ""N-2-Hydroxyethylpiperazine-N'-2'-ethanesulfonic Acid""}, {'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}]",79.0,0.053379,The FF diet increased concentrations of 18-hydroxyeicosapentaenoic acid (18-HEPE) and,"[{'ForeName': 'Topi', 'Initials': 'T', 'LastName': 'Meuronen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland. Electronic address: topim@uef.fi.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Lankinen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Fauland', 'Affiliation': 'Division of Physiological Chemistry 2, Department of Medical Biochemistry and Biophysics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Bun-Ichi', 'Initials': 'BI', 'LastName': 'Shimizu', 'Affiliation': 'Division of Physiological Chemistry 2, Department of Medical Biochemistry and Biophysics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Vanessa D', 'Initials': 'VD', 'LastName': 'de Mello', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Laaksonen', 'Affiliation': 'Department of Medicine, Endocrinology and Clinical Nutrition, Kuopio University Hospital, 70029 Kuopio University Hospital, Finland; Institute of Biomedicine, Physiology, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'Craig E', 'Initials': 'CE', 'LastName': 'Wheelock', 'Affiliation': 'Division of Physiological Chemistry 2, Department of Medical Biochemistry and Biophysics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Arja T', 'Initials': 'AT', 'LastName': 'Erkkilä', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'Ursula S', 'Initials': 'US', 'LastName': 'Schwab', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland; Department of Medicine, Endocrinology and Clinical Nutrition, Kuopio University Hospital, 70029 Kuopio University Hospital, Finland.'}]","Prostaglandins, leukotrienes, and essential fatty acids",['10.1016/j.plefa.2020.102143']
2143,32512380,Continuous Wound Infiltration With Ropivacaine After Mastectomy: A Randomized Controlled Trial.,"BACKGROUND


To evaluate the efficacy of continuous wound infiltration with ropivacaine to reduce acute postoperative pain in patients undergoing mastectomy for carcinoma of the breast.
MATERIALS AND METHODS


A randomized, double-blind, placebo-controlled trial was conducted. One hundred fifty patients were randomly assigned to receive continuous ropivacaine (0.2%) (group A, n = 74) or saline solution (0.9%) (group B, n = 76) at 10 mL/h for 48 h through a multilumen catheter placed during the surgical procedure. Postoperative morphine consumption and visual analog scale (VAS) pain scores were recorded. A quality of life score (Quality of life questionnaire Core 30) and a VAS score were obtained at 1, 3, and 6 mo after surgery.
RESULTS


The difference in mean morphine consumption between the two groups was close to significance during the first 48 h postsurgery (P = 0.056; 10.8 ± 16.5 versus 4.8 ± 10.4 mg). At day 1, patients in the ropivacaine-infusion group had lower morphine consumption than the control group (P = 0.0026). The link between local ropivacaine infiltration and a decrease in mean postoperative VAS scores reached significance for the first 24 h postsurgery (P = 0.039). No significant difference was found between the two arms for VAS pain scores (P = 0.36) or for quality of life (overall QLQ-C30 score, P = 0.09) at 1, 3, or 6 mo.
CONCLUSIONS


Continuous wound infiltration with ropivacaine is efficacious in reducing postoperative pain. Quality of life and chronic pain at 1, 3, and 6 mo were not improved by ropivacaine wound infiltration.",2020,"No significant difference was found between the two arms for VAS pain scores (P = 0.36) or for quality of life (overall QLQ-C30 score, P = 0.09) at 1, 3, or 6 mo.
","['patients undergoing mastectomy for carcinoma of the breast', 'One hundred fifty patients']","['ropivacaine-infusion', 'ropivacaine', 'Mastectomy', 'saline solution', 'continuous ropivacaine', 'Ropivacaine', 'placebo']","['Quality of life and chronic pain', 'acute postoperative pain', 'A quality of life score (Quality of life questionnaire Core 30) and a VAS score', 'postoperative pain', 'mean morphine consumption', 'mean postoperative VAS scores', 'morphine consumption', 'quality of life (overall QLQ-C30 score', 'VAS pain scores', 'Postoperative morphine consumption and visual analog scale (VAS) pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0238033', 'cui_str': 'Carcinoma of male breast'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C2215257', 'cui_str': 'Acute postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",150.0,0.396965,"No significant difference was found between the two arms for VAS pain scores (P = 0.36) or for quality of life (overall QLQ-C30 score, P = 0.09) at 1, 3, or 6 mo.
","[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Beguinot', 'Affiliation': ""Département d'oncologie, Médipôle Hôpital Mutualiste Lyon Villeurbanne, Villeurbanne, France.""}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Monrigal', 'Affiliation': 'Département de Chirurgie Sénologique, Montpellier Institut du Sein, Clinique Clémentville, Montpellier, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Kwiatkowski', 'Affiliation': 'Délégation Recherche Clinique & Innovation, Centre Jean Perrin, Centre de Lutte contre le Cancer, Clermont-Ferrand, France.'}, {'ForeName': 'Angeline', 'Initials': 'A', 'LastName': 'Ginzac', 'Affiliation': ""Délégation Recherche Clinique & Innovation, Centre Jean Perrin, Centre de Lutte contre le Cancer, Clermont-Ferrand, France; Université Clermont Auvergne, Centre Jean Perrin, INSERM, U1240 Imagerie Moléculaire et Stratégies Théranostiques, Clermont-Ferrand, France; Centre d'Investigation Clinique, UMR501, Clermont-Ferrand, France. Electronic address: Angeline.ginzac@clermont.unicancer.fr.""}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Joly', 'Affiliation': ""Département d'anesthésie-réanimation, Centre Jean Perrin, Centre de Lutte contre le Cancer, Clermont-Ferrand, France.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Gayraud', 'Affiliation': ""Département d'anesthésie-réanimation, Centre Jean Perrin, Centre de Lutte contre le Cancer, Clermont-Ferrand, France.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Le Bouedec', 'Affiliation': 'Département de Chirurgie Oncologique, Centre Jean Perrin, Centre de Lutte contre le Cancer, Clermont-Ferrand, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Gimbergues', 'Affiliation': 'Département de Chirurgie Oncologique, Centre Jean Perrin, Centre de Lutte contre le Cancer, Clermont-Ferrand, France.'}]",The Journal of surgical research,['10.1016/j.jss.2020.05.006']
2144,32512477,"Effect of a maximal exercise test on serum and urinary concentrations of magnesium, phosphorous, rubidium and strontium in athletes.","AIM


This study aims to determine the changes induced by a maximal exercise test until exhaustion on the serum and urinary concentrations of Magnesium (Mg), Phosphorous (P), Rubidium (Rb) and Strontium (Sr) in athletes (AG) and sedentary students (SG).
METHODS


Fifty subjects participated in the study divided into two groups. In AG there were twenty-five male athletes and in SG there were twenty-five male sedentary students. Both groups performed an exercise test until exhaustion, starting at 8 or 10 km/h respectively, and increasing the speed at 1 km/h every 400 m. Serum and urine samples were obtained from all participants before and after the test.
RESULTS


Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG. Comparing the pre and post-test values, corrected or non-corrected for hemoconcentration in serum and for creatinine in urine, AG showed a decrease in serum Mg (p < 0.05), in serum P (p < 0.01) and in urinary Sr (p < 0.01) while an increase was observed in urinary P (p < 0.05) and in urinary Rb (p < 0.05).
CONCLUSIONS


It can be concluded that a treadmill test until exhaustion leads to changes in serum and urinary concentrations of minerals in both AG and SG males. This may reflect an adaptive response of the body to overcome the physical stress and, in some cases, to avoid loss of these elements.",2020,"Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG.","['athletes', 'athletes (AG) and sedentary students (SG', 'In AG there were twenty-five male athletes and in SG there were twenty-five male sedentary students', 'Fifty subjects participated in the study divided into two groups']",['maximal exercise test'],"['urinary Rb', 'serum and urinary concentrations of Magnesium (Mg), Phosphorous (P), Rubidium (Rb) and Strontium (Sr', 'urinary Sr', 'serum and urinary concentrations of magnesium, phosphorous, rubidium and strontium']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0035930', 'cui_str': 'Rubidium'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0232827', 'cui_str': 'Urinary concentration'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0038467', 'cui_str': 'Strontium'}]",25.0,0.0207851,"Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG.","[{'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Muñoz', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: diegomun@unex.es.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Grijota', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: fgrijota@gmail.com.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Siquier-Coll', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: jsiquier@alumnos.unex.es.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Toro-Román', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: vtororom@alumnos.unex.es.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Bartolomé', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: ignbs.1991@gmail.com.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Maynar-Mariño', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: mmaynar@unex.es.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126572']
2145,32512498,"Assessing the effectiveness of a pediatrician-led newborn parenting class on maternal newborn-care knowledge, confidence and anxiety: A quasi-randomized controlled trial.","BACKGROUND


The postpartum hospital stay is a unique opportunity for clinicians to educate parents on the importance of promoting early child development. Pediatricians are well-positioned to address both medical and developmental concerns during critical periods of development, yet very few parenting interventions are led by pediatricians.
AIMS


To assess the impact of a novel one-hour long pediatrician-led Newborn Class on maternal knowledge, confidence, and anxiety.
METHODS


We conducted a quasi-randomized controlled trial to evaluate the effectiveness of the Newborn Class. First-time mothers who delivered a full-term singleton vaginally with no major complications and attended the class were recruited. Mothers who expressed a desire to attend the class but were discharged before a class was offered served as controls.
OUTCOME MEASURES


Maternal self-perceived parental confidence and anxiety were measured using standardized scales [Karitane Parenting Confidence Scale (KPCS) and State-Trait Anxiety Inventory for Adults (STAI-AD)]. Knowledge on newborn care was assessed using a novel scale.
RESULTS


A total of 84 participants (intervention n = 36, control n = 48) were included in the study. Mothers who attended the class showed significantly higher levels of knowledge compared to the control group (Knowledge test, Two-tailed t-test, mean [SD], 8.08 [1.06] vs 6.78 [1.25]; P<0.001) as well as significantly higher parenting confidence levels (KPCS, Two-tailed t-test, mean [SD], 39.31 [3.88] vs 35.20 [3.99]; P<0.001). No change was observed in the overall level of anxiety (STAI-AD, Two-tailed t-test, mean [SD], 35.50 [8.73] vs 38.5 [9.53]; P=0.164).
CONCLUSIONS


A short pediatrician-led parenting intervention may be an effective tool in improving maternal confidence and newborn care knowledge. Given the importance of the newborn period in establishing healthy developmental trajectories, there is a crucial need for cost- and time-effective intervention that can be widely implemented to promote parental knowledge and confidence with the ultimate goal of fostering healthy development in children.",2020,"No change was observed in the overall level of anxiety (STAI-AD, Two-tailed t-test, mean [SD], 35.50 [8.73] vs 38.5 [9.53]; P=0.164).
","['Mothers who expressed a desire to attend the class but were discharged before a class was offered served as controls', 'First-time mothers who delivered a full-term singleton vaginally with no major complications and attended the class were recruited', '84 participants (intervention n\xa0=\xa036, control n\xa0=\xa048) were included in the study']","['pediatrician-led newborn parenting class', 'novel one-hour long pediatrician-led Newborn Class', 'Newborn Class']","['maternal knowledge, confidence, and anxiety', 'levels of knowledge', 'standardized scales [Karitane Parenting Confidence Scale (KPCS) and State-Trait Anxiety Inventory for Adults (STAI-AD', 'overall level of anxiety (STAI-AD', 'Maternal self-perceived parental confidence and anxiety', 'parenting confidence levels (KPCS', 'maternal newborn-care knowledge, confidence and anxiety']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0237433', 'cui_str': 'Pediatrician'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0205166', 'cui_str': 'Long'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0204792', 'cui_str': 'Routine care of newborn'}]",84.0,0.0881763,"No change was observed in the overall level of anxiety (STAI-AD, Two-tailed t-test, mean [SD], 35.50 [8.73] vs 38.5 [9.53]; P=0.164).
","[{'ForeName': 'Aileen', 'Initials': 'A', 'LastName': 'Gozali', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Department of Pediatrics, One Gustave L. Levy Place, New York, NY 10029, United States; Columbia University Irving Medical Center, Departments of Pediatrics and Psychiatry, Pardes Rm 4932, 1051 Riverside Drive, New York, NY 10032, United States. Electronic address: ag3827@columbia.edu.'}, {'ForeName': 'Sherika', 'Initials': 'S', 'LastName': 'Gibson', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Department of Pediatrics, One Gustave L. Levy Place, New York, NY 10029, United States. Electronic address: sherikagibson95@gmail.com.'}, {'ForeName': 'Lianna R', 'Initials': 'LR', 'LastName': 'Lipton', 'Affiliation': ""Boston Children's Hospital, Department of Pediatrics - Division of Developmental Medicine, 300 Longwood Avenue, Boston, MA 02115, United States. Electronic address: lianna.lipton@childrens.harvard.edu.""}, {'ForeName': 'Aliza W', 'Initials': 'AW', 'LastName': 'Pressman', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Department of Pediatrics, One Gustave L. Levy Place, New York, NY 10029, United States. Electronic address: aliza.pressman@gmail.com.'}, {'ForeName': 'Blair S', 'Initials': 'BS', 'LastName': 'Hammond', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Department of Pediatrics, One Gustave L. Levy Place, New York, NY 10029, United States. Electronic address: blair.hammond@mssm.edu.'}, {'ForeName': 'Dani', 'Initials': 'D', 'LastName': 'Dumitriu', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Department of Pediatrics, One Gustave L. Levy Place, New York, NY 10029, United States; Columbia University Irving Medical Center, Departments of Pediatrics and Psychiatry, Pardes Rm 4932, 1051 Riverside Drive, New York, NY 10032, United States. Electronic address: dani.dumitriu@columbia.edu.'}]",Early human development,['10.1016/j.earlhumdev.2020.105082']
2146,32513359,Glycerol Preserved Amnion: A Viable Source of Biological Dressing for Superficial Partial Thickness Facial Burns.,"OBJECTIVES


To evaluate the role of amnion as a biological dressing in superficial partial thickness facial burns.
STUDY DESIGN


Randomized controlled trial.
PLACE AND DURATION OF STUDY


Jinnah Burn and Reconstructive Surgery Centre, Lahore, from January 2017 to December 2018.
METHODS


Sixty two patients with superficial partial thickness facial burns were randomly divided into two groups (A and B). Ointment containing Polymyxin B and Bacitracin was applied in group A (n=28) while amnion was applied in group B (n=34). The patients were monitored for the pain related to burns needing analgesia, time of healing of burns, and cosmetic outcome of the facial scarring over a period of six months.
RESULTS


The mean age of the patients was 26.5 ±12.2 years. 39 (62.9%) patients were male and 23 (37.1%) were females. The mean percent total facial surface area burned was 2.7% ±1. None of the patients developed facial wound infections. The average healing time was 6 ±2 days. The mean frequency of analgesia for 3 days of group B was less as compared to group A. infection rate was similar in both groups. No significant difference was observed in VAS score at 1, 3 and 6 month follow up between both groups.
CONCLUSION


Amnion is a safe, cost effective and most readily available biological dressing for superficial partial thickness facial burn management. Key Words: Amnion, Facial burn, Biological dressing, Scarring, Partial thickness burn.",2020,The mean frequency of analgesia for 3 days of group B was less as compared to group A. infection rate was similar in both groups.,"['superficial partial thickness facial burns', 'patients were male and 23 (37.1%) were females', 'Sixty two patients with superficial partial thickness facial burns', 'Jinnah Burn and Reconstructive Surgery Centre, Lahore, from January 2017 to December 2018', 'Superficial Partial Thickness Facial Burns']","['Biological Dressing', 'Glycerol Preserved Amnion', 'Polymyxin B and Bacitracin']","['mean percent total facial surface area burned', 'VAS score', 'average healing time', 'infection rate', 'pain related to burns needing analgesia, time of healing of burns, and cosmetic outcome of the facial scarring', 'mean frequency of analgesia', 'facial wound infections']","[{'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0443275', 'cui_str': 'Partial thickness'}, {'cui': 'C0433163', 'cui_str': 'Burn of face'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0524865', 'cui_str': 'Reconstruction - action'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0005513', 'cui_str': 'Dressing, Biological'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0002630', 'cui_str': 'Structure of amnion'}, {'cui': 'C0032535', 'cui_str': 'Polymyxin B'}, {'cui': 'C0004599', 'cui_str': 'Bacitracin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}]",62.0,0.0146394,The mean frequency of analgesia for 3 days of group B was less as compared to group A. infection rate was similar in both groups.,"[{'ForeName': 'Muhammad Sheraz', 'Initials': 'MS', 'LastName': 'Raza', 'Affiliation': 'Department of Plastic Surgery, Jinnah Burn and Reconstructive Surgery Center, Lahore, Pakistan.'}, {'ForeName': 'Muhammad Umar', 'Initials': 'MU', 'LastName': 'Asif', 'Affiliation': 'Department of Plastic Surgery, Jinnah Burn and Reconstructive Surgery Center, Lahore, Pakistan.'}, {'ForeName': 'Zain Ul', 'Initials': 'ZU', 'LastName': 'Abidin', 'Affiliation': 'Department of Plastic Surgery, Jinnah Burn and Reconstructive Surgery Center, Lahore, Pakistan.'}, {'ForeName': 'Farrukh Aslam', 'Initials': 'FA', 'LastName': 'Khalid', 'Affiliation': 'Department of Plastic Surgery, Jinnah Burn and Reconstructive Surgery Center, Lahore, Pakistan.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Ilyas', 'Affiliation': 'Department of Plastic Surgery, Jinnah Burn and Reconstructive Surgery Center, Lahore, Pakistan.'}, {'ForeName': 'Moazzam Nazeer', 'Initials': 'MN', 'LastName': 'Tarar', 'Affiliation': 'Department of Plastic Surgery, Jinnah Burn and Reconstructive Surgery Center, Lahore, Pakistan.'}]",Journal of the College of Physicians and Surgeons--Pakistan : JCPSP,['10.29271/jcpsp.2020.04.394']
2147,32515246,Novel Insights Into the Effects of Interleukin 6 Antagonism in Non-ST-Segment-Elevation Myocardial Infarction Employing the SOMAscan Proteomics Platform.,"Background Interleukin 6 concentration is associated with myocardial injury, heart failure, and mortality after myocardial infarction. In the Norwegian tocilizumab non-ST-segment-elevation myocardial infarction trial, the first randomized trial of interleukin 6 blockade in myocardial infarction, concentration of both C-reactive protein and troponin T were reduced in the active treatment arm. In this follow-up study, an aptamer-based proteomic approach was employed to discover additional plasma proteins modulated by tocilizumab treatment to gain novel insights into the effects of this therapeutic approach. Methods and Results Plasma from percutaneous coronary intervention-treated patients, 24 in the active intervention and 24 in the placebo-control arm, drawn 48 hours postrandomization were randomly selected for analysis with the SOMAscan assay. Employing slow off-rate aptamers, the relative abundance of 1074 circulating proteins was measured. Proteins identified as being significantly different between groups were subsequently measured by enzyme immunoassay in the whole trial cohort (117 patients) at all time points (days 1-3 [7 time points] and 3 and 6 months). Five proteins identified by the SOMAscan assay, and subsequently confirmed by enzyme immunoassay, were significantly altered by tocilizumab administration. The acute-phase proteins lipopolysaccharide-binding protein, hepcidin, and insulin-like growth factor-binding protein 4 were all reduced during the hospitalization phase, as was the monocyte chemoattractant C-C motif chemokine ligand 23. Proteinase 3, released primarily from neutrophils, was significantly elevated. Conclusions Employing the SOMAscan aptamer-based proteomics platform, 5 proteins were newly identified that are modulated by interleukin 6 antagonism and may mediate the therapeutic effects of tocilizumab in non-ST-segment-elevation myocardial infarction.",2020,"Five proteins identified by the SOMAscan assay, and subsequently confirmed by enzyme immunoassay, were significantly altered by tocilizumab administration.","['percutaneous coronary intervention-treated patients, 24 in the active intervention and 24 in the placebo-control arm, drawn 48\xa0hours postrandomization', 'Non-ST-Segment-Elevation Myocardial Infarction']",['tocilizumab'],"['myocardial infarction, concentration of both C-reactive protein and troponin T']","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C1536221', 'cui_str': 'Non ST segment elevation myocardial infarction'}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}]","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}]",5.0,0.0679143,"Five proteins identified by the SOMAscan assay, and subsequently confirmed by enzyme immunoassay, were significantly altered by tocilizumab administration.","[{'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'George', 'Affiliation': 'Department of Clinical Pharmacology University College London London United Kingdom.'}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Kleveland', 'Affiliation': 'Clinic of Cardiology St Olavs Hospital Trondheim Norway.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Garcia-Hernandez', 'Affiliation': 'Centre for Cardiovascular Genetics Institute of Cardiovascular Science University College London London United Kingdom.'}, {'ForeName': 'Jutta', 'Initials': 'J', 'LastName': 'Palmen', 'Affiliation': 'Centre for Cardiovascular Genetics Institute of Cardiovascular Science University College London London United Kingdom.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Lovering', 'Affiliation': 'Functional Gene Annotation, Preclinical and Fundamental Science Institute of Cardiovascular Science University College London London United Kingdom.'}, {'ForeName': 'Rune', 'Initials': 'R', 'LastName': 'Wiseth', 'Affiliation': 'Clinic of Cardiology St Olavs Hospital Trondheim Norway.'}, {'ForeName': 'Pål', 'Initials': 'P', 'LastName': 'Aukrust', 'Affiliation': 'K.G. Jebsen Thrombosis Research and Expertise Center University of Tromsø Tromsø Norway.'}, {'ForeName': 'Jorgen', 'Initials': 'J', 'LastName': 'Engmann', 'Affiliation': 'Centre for Cardiovascular Genetics Institute of Cardiovascular Science University College London London United Kingdom.'}, {'ForeName': 'Jan Kristian', 'Initials': 'JK', 'LastName': 'Damås', 'Affiliation': 'Centre of Molecular Inflammation Research Department of Clinical and Molecular Medicine NTNU Trondheim Norway.'}, {'ForeName': 'Aroon D', 'Initials': 'AD', 'LastName': 'Hingorani', 'Affiliation': 'Centre for Cardiovascular Genetics Institute of Cardiovascular Science University College London London United Kingdom.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Gullestad', 'Affiliation': 'Institute of Clinical Medicine University of Oslo Norway.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Casas', 'Affiliation': 'Institute of Health Informatics University College London London United Kingdom.'}, {'ForeName': 'Thor', 'Initials': 'T', 'LastName': 'Ueland', 'Affiliation': 'K.G. Jebsen Thrombosis Research and Expertise Center University of Tromsø Tromsø Norway.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.015628']
2148,32515255,"Correction to: Oxygen Exposure During Cardiopulmonary Resuscitation Is Associated With Cerebral Oxidative Injury in a Randomized, Blinded, Controlled, Preclinical Trial.",,2020,,[],['Oxygen Exposure During Cardiopulmonary Resuscitation'],[],[],"[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}]",[],,0.130556,,[],Journal of the American Heart Association,['10.1161/JAHA.119.014549']
2149,32516744,Evaluation of factors influencing obesity and the effect of a 12-week home-based exercise program in people with epilepsy - Randomized control trial.,"BACKGROUND


Association of obesity, quality of life (QoL), and physical fitness in people with epilepsy (PWE) is rarely reported. We evaluate the effect of a 12-week home-based exercise program on weight reduction and physical capacity in PWE.
METHODS


In 173 PWE, physical fitness was assessed by using six-minute walk test (6MWT) and one-minute step test. Self-reported QoL data was collected using a 12-Item Short Form Survey (SF-12) questionnaire; further physical (PCS) and mental (MCS) component scores were derived. Effect of exercise was evaluated using randomized study of 110 PWE, divided into control and exercise groups of 55 each.
RESULTS


At baseline, mean age of study population was 25.85 ± 9.62 years with 77 (44.5%) women. Average body mass index (BMI) was 29.33 ± 6.17 kg/m 2 . Mean PCS and MCS were 45.95 ± 7.92 and 45.72 ± 10.40 respectively. In 124 (71.7%) PWE with obesity, while high-density lipoprotein (HDL-C) (46.10 ± 12.32 vs. 39.30 ± 10.39 mg/dL; p < .001) was lower, low-density lipoprotein (LDL-C) (101.60 ± 37.51 vs. 113.89 ± 32.65 mg/dL; p = .035) was high. Both the randomized groups were comparable for type and number of antiepileptic drugs (AEDs) used. At 12-week follow-up, PWE in the exercise group reduced 7.65 ± 5.62 kg while control group gained an average of 4.01 ± 4.74 kg (p < .001). Distance walked in 6MWT (293.07 ± 118.73 vs. 464.29 ± 55.33 m; p = .007) and PCS (48.59 ± 8.57 vs. 52.62 ± 4.03; p = .006) were higher in exercise group whereas MCS did not differ between the groups. None of the participants reported seizure during the 12-week follow-up period.
CONCLUSION


People with epilepsy have low PCS and MCS scores; PWE with obesity have altered metabolic profile when compared to PWE without obesity. A 12-week, home-based exercise program significantly reduces weight and improves physical capacity, irrespective of AEDs used. Trials with larger sample size and longer follow-up are required to validate our findings.",2020,"A 12-week, home-based exercise program significantly reduces weight and improves physical capacity, irrespective of AEDs used.","['110 PWE, divided into control and exercise groups of 55 each', 'people with epilepsy - Randomized control trial', 'At baseline, mean age of study population was 25.85\u202f±\u202f9.62\u202fyears with 77 (44.5%) women', 'people with epilepsy (PWE']",['home-based exercise program'],"['12-Item Short Form Survey (SF-12) questionnaire; further physical (PCS) and mental (MCS) component scores', 'Average body mass index (BMI', 'physical fitness', 'Distance walked in 6MWT', 'weight and improves physical capacity', 'weight reduction and physical capacity', 'Mean PCS and MCS', 'low-density lipoprotein (LDL-C']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}, {'cui': 'C0036221', 'cui_str': 'Mast cell sarcoma'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}]",,0.0800908,"A 12-week, home-based exercise program significantly reduces weight and improves physical capacity, irrespective of AEDs used.","[{'ForeName': '', 'Initials': '', 'LastName': 'SudhindraVooturi', 'Affiliation': 'Department of Neurology, Krishna Institute of Medical Sciences, Secunderabad, Telangana, India. Electronic address: sudhindragupta@gmail.com.'}, {'ForeName': 'A N R', 'Initials': 'ANR', 'LastName': 'Lakshmi', 'Affiliation': 'Department of Physiology, Chalmeda Anand Rao Institute of Medical Sciences, Karimnagar, Telangana, India.'}, {'ForeName': 'Sita', 'Initials': 'S', 'LastName': 'Jayalakshmi', 'Affiliation': 'Department of Neurology, Krishna Institute of Medical Sciences, Secunderabad, Telangana, India.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107148']
2150,32519680,"The assessment of the impact of a training process on the habituation of the vestibular-vegetative system, using a special rotational test as a condition of maintaining flight safety.","OBJECTIVES


The authors formulated a hypothesis that, on completion of the training program by cadets, their vestibular habituation would increase, measured by the time of the duration of the test on the unlocked looping, in contrast to the initial values and the control group.
MATERIAL AND METHODS


The research involved 35 male cadets, first-year students of the Polish Air Force Academy in Dęblin. The examined persons were on average 20 years of age. They were divided into 2 groups. Group A (N = 25, tested) continued training on Special Aviation Gymnastic Instruments (SAGI). The cadets were a homogeneous group of participants in the jet pilot course, selected by the Military Aeromedical Board. Group B (N = 10, control) conducted the standard physical military education program. Groups A and B were tested on the unlocked looping before and after the training process. In the training process, the groups had heart rate (HR) monitored.
RESULTS


The cadets in group A on the test in the unlocked looping, at the beginning of the training period, had an average score of 468.5±96.6 s, and on completion of the training period 575.6±47.9 s, which is a statistically significant difference at p < 0.000001. Similarly, the examined individuals in group B received an average score of 396.2±31.8 s, and at the end of the training period 473.4±72.0 s, which is a statistically significant difference at p < 0.01. In group A, a statistically significant decrease in the average HR value was observed. In group B, there was a statistically significant increase in the average HR value.
CONCLUSIONS


The exercises on SAGI have a beneficial impact on improving the habituation of the vestibular organ in training cadets in examination II, as opposed to examination I and the control group. Int J Occup Med Environ Health. 2020;33(4):497-506.",2020,"In group B, there was a statistically significant increase in the average HR value.
","['35 male cadets, first-year students of the Polish Air Force Academy in Dęblin']",['standard physical military education program'],"['heart rate (HR) monitored', 'average HR value']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0000876', 'cui_str': 'Academies'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",35.0,0.0136962,"In group B, there was a statistically significant increase in the average HR value.
","[{'ForeName': 'Zbigniew', 'Initials': 'Z', 'LastName': 'Wochyński', 'Affiliation': 'Polish Air Force University, Dęblin, Poland (Department of Aviation Safety Transport).'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Krawczyk', 'Affiliation': 'Polish Air Force University, Dęblin, Poland (Department of Aviation).'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Cur', 'Affiliation': '3rd Airlift Wing, Powidz, Poland.'}]",International journal of occupational medicine and environmental health,['10.13075/ijomeh.1896.01515']
2151,31820274,Dalfampridine to Improve Balance in Multiple Sclerosis: Substudy from a Randomized Placebo-Controlled Trial.,"This was a substudy of a randomized, double-blind, placebo-controlled trial originally designed to explore the effect of dalfampridine on information processing speed (2013-002558-64 EU Clinical Trials Register) in patients with multiple sclerosis (MS). A total of 120 patients were originally randomized in a 2:1 ratio to receive dalfampridine 10 mg or placebo twice daily for 12 weeks. Here, we sought to explore the effect of dalfampridine on static balance in single-task and dual-task conditions in a subgroup of 41 patients. They underwent static posturography in quiet standing (single-task) and while performing the Stroop test (dual-task) at randomization (baseline), after 12 weeks and after a 4-week wash-out period. Baseline characteristics of active group (n = 27) did not differ from those of placebo group (n = 14). Dalfampridine treatment was associated with better balance control than placebo in both single-task (F = 4.80, p = 0.034) and dual-task (F = 6.42, p = 0.015) conditions, with small-to-moderate effect sizes (Cohen's f 2  = 0.122-0.162). The beneficial effect of dalfampridine was not retained 4 weeks after its discontinuation. The rate of accidental falls per month did not differ between the two groups (p = 0.12). Our preliminary findings suggest that dalfampridine can be considered a potential option to treat balance impairment due to MS. Larger sample sizes are needed to verify if the beneficial effect of dalfampridine on balance can be translated into a reduced risk of accidental falls.",2020,"Dalfampridine treatment was associated with better balance control than placebo in both single-task (F = 4.80, p = 0.034) and dual-task (F = 6.42, p = 0.015) conditions, with small-to-moderate effect sizes (Cohen's f 2  = 0.122-0.162).","['A total of 120 patients', 'a subgroup of 41 patients', 'patients with multiple sclerosis (MS', 'Multiple Sclerosis']","['Placebo', 'static posturography in quiet standing (single-task) and while performing the Stroop test (dual-task', 'dalfampridine 10 mg or placebo', 'dalfampridine', 'Dalfampridine', 'placebo']","['balance control', 'rate of accidental falls', 'static balance']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0919611', 'cui_str': 'Posturography'}, {'cui': 'C0439654', 'cui_str': 'Quiet'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C2732148', 'cui_str': 'dalfampridine 10 MG'}, {'cui': 'C0000477', 'cui_str': 'dalfampridine'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0441463', 'cui_str': 'Static'}]",120.0,0.478695,"Dalfampridine treatment was associated with better balance control than placebo in both single-task (F = 4.80, p = 0.034) and dual-task (F = 6.42, p = 0.015) conditions, with small-to-moderate effect sizes (Cohen's f 2  = 0.122-0.162).","[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Prosperini', 'Affiliation': 'Dept. of Neurosciences, S. Camillo-Forlanini Hospital, C.ne Gianicolense 87, 00152, Rome, Italy. luca.prosperini@gmail.com.'}, {'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Castelli', 'Affiliation': 'Istituto di Ricerca e Cura a Carattere Scientifico (IRCCS) Fondazione Don Carlo Gnocchi, -, Piazzale Morandi 6, 20121, Milano, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'De Giglio', 'Affiliation': 'Neurology Unit, S. Filippo Neri Hospital, Via G. Martinotti 20, 00135, Rome, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Bonanno', 'Affiliation': 'S. Andrea Hospital, Sapienza University, Via di Grottarossa 1035, 00189, Rome, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Gasperini', 'Affiliation': 'Dept. of Neurosciences, S. Camillo-Forlanini Hospital, C.ne Gianicolense 87, 00152, Rome, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Pozzilli', 'Affiliation': 'S. Andrea Hospital, Sapienza University, Via di Grottarossa 1035, 00189, Rome, Italy.'}]",Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics,['10.1007/s13311-019-00813-5']
2152,32521538,"Colon-delivered short-chain fatty acids attenuate the cortisol response to psychosocial stress in healthy men: a randomized, placebo-controlled trial.","Short-chain fatty acids (SCFAs) are products of microbial fermentation of dietary fiber in the colon and may mediate microbiota-gut-brain communication. However, their role in modulating psychobiological processes that underlie the development of stress- and anxiety-related disorders is not mechanistically studied in humans. In this triple-blind, randomized, placebo-controlled intervention trial, we examine in a parallel group design the effects of 1-week colonic SCFA-mixture delivery in doses equivalent to fermentation of 10 g or 20 g of arabinoxylan oligosaccharides on responses to psychosocial stress and fear tasks in 66 healthy men. We demonstrate that low and high doses of SCFAs significantly attenuate the cortisol response to psychosocial stress compared to placebo. Both doses of SCFAs increase serum SCFA levels and this increase in circulating SCFAs co-varies significantly with the attenuation of the cortisol response to psychosocial stress. Colonic SCFA delivery does not modulate fecal SCFA concentrations, serum brain-derived neurotrophic factor, cortisol awakening response, fear learning and extinction, or subjective mood ratings. These results demonstrate that colon-delivered SCFAs modulate hypothalamic-pituitary-adrenal axis reactivity to psychosocial stress, thereby supporting their hypothesized role in microbiota-gut-brain communication.",2020,"Colonic SCFA delivery does not modulate fecal SCFA concentrations, serum brain-derived neurotrophic factor, cortisol awakening response, fear learning and extinction, or subjective mood ratings.","['healthy men', '66 healthy men']","['Short-chain fatty acids (SCFAs', 'colonic SCFA-mixture delivery', 'SCFAs', 'Colon-delivered short-chain fatty acids', 'arabinoxylan oligosaccharides', 'placebo']","['fecal SCFA concentrations, serum brain-derived neurotrophic factor, cortisol awakening response, fear learning and extinction, or subjective mood ratings', 'cortisol response to psychosocial stress', 'serum SCFA levels']","[{'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0250438', 'cui_str': 'arabinoxylan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",66.0,0.031091,"Colonic SCFA delivery does not modulate fecal SCFA concentrations, serum brain-derived neurotrophic factor, cortisol awakening response, fear learning and extinction, or subjective mood ratings.","[{'ForeName': 'Boushra', 'Initials': 'B', 'LastName': 'Dalile', 'Affiliation': 'Translational Research Center in Gastrointestinal Disorders (TARGID), Department of Chronic Diseases, Metabolism, and Ageing, Faculty of Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Vervliet', 'Affiliation': 'Laboratory of Biological Psychology, Brain & Cognition, Faculty of Psychology and Educational Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Bergonzelli', 'Affiliation': 'Department of Gastrointestinal Health, Nestlé Research, Société des Produits Nestlé S.A., Lausanne, Switzerland.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Verbeke', 'Affiliation': 'Translational Research Center in Gastrointestinal Disorders (TARGID), Department of Chronic Diseases, Metabolism, and Ageing, Faculty of Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Van Oudenhove', 'Affiliation': 'Translational Research Center in Gastrointestinal Disorders (TARGID), Department of Chronic Diseases, Metabolism, and Ageing, Faculty of Medicine, KU Leuven, Leuven, Belgium. lukas.vanoudenhove@kuleuven.be.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0732-x']
2153,32521976,[Effect of an oral nutritional supplementation on nutritional status and quality of life in patients with colorectal cancer and postoperative adjuvant chemotherapy: A multi-center prospective randomized control trial].,"Objective:  To evaluate the effect of oral nutritional supplementation (ONS) on the nutritional status and quality of life in patients with colorectal cancer and postoperative adjuvant chemotherapy.  Methods:  This study was registered in the Chinese Clinical Trial Registry (ChiCTR-TRC-13003798). A multi-center randomized controlled trial was conducted. Colorectal cancer patients who underwent radical surgery and postoperative adjuvant chemotherapy, and had nutritional risk (nutrition risk screening 2002 score ≥3) when discharge from hospital in six hospitals (Beijing Hospital, Peking University Third Hospital, Guangzhou Nanfang Hospital, Shanghai Xinhua Hospital, Shanghai Ruijin Hospital, and Shanghai The Sixth People's Hospital) from June 2013 to August 2015 were prospectively enrolled. These patients were randomly divided into the ONS group and control group. Patients in the ONS group received dietary guidance and oral nutritional supplements (2092 kJ/day, whole protein enteral nutrition) for 90 days after discharge from hospital, while patients in the control group only received dietary guidance. Anthropometric measurements (body weight, body mass index [BMI], upper arm circumference, gripping power of the dominant hand, triceps skin fold), nutrition-related laboratory tests (hemoglobin, albumin, prealbumin, total cholesterol, triglyceride), gastrointestinal function scores and quality of life (evaluated by EuroQol five dimensions questionnaire) were collected and compared at baseline (at discharge), and at 30-day, 60-day and 90-day after discharge.  Results:  A total of 90 patients were included into this multi-center study, of whom 5 patients dropped out, 43 patients were assigned to the ONS group and 42 patients to the control group. Compared with baseline, the body weight of patients in the ONS group increased by (1.523±0.525) kg at 60-day and (1.967±0.661) kg at 90-day, which were significantly higher than those of patients in the control group [60-day: (-0.325±0.518) kg,  P =0.015; 90-day: (-0.224±0.705) kg,  P =0.027, respectively]. A similar pattern was observed for BMI, the ONS group increased by (0.552±0.203) kg/m(2) at 60-day and (0.765±0.205) kg/m(2) at 90-day, which were significantly higher than those of patients in control group [60-day: (-0.067±0.202) kg/m(2),  P =0.034; 90-day: (0.022±0.210) kg/m(2),  P =0.013]. No significant differences of other anthropometric measurements and nutrition-related laboratory tests were found between the two groups (all  P >0.05). Furthermore, there were no significant differences of improvement in gastrointestinal function and quality of life between two groups (all  P >0.05).  Conclusion:  Oral nutritional supplements can improve the body weight and BMI of colorectal cancer patients with nutritional risk receiving postoperative adjuvant chemotherapy, though it does not improve the quality of life.",2020,No significant differences of other anthropometric measurements and nutrition-related laboratory tests were found between the two groups (all  P >0.05).,"['A total of 90 patients were included into this multi-center study, of whom 5 patients dropped out, 43 patients were assigned to the ONS group and 42 patients to the control group', ""Colorectal cancer patients who underwent radical surgery and postoperative adjuvant chemotherapy, and had nutritional risk (nutrition risk screening 2002 score ≥3) when discharge from hospital in six hospitals (Beijing Hospital, Peking University Third Hospital, Guangzhou Nanfang Hospital, Shanghai Xinhua Hospital, Shanghai Ruijin Hospital, and Shanghai The Sixth People's Hospital) from June 2013 to August 2015 were prospectively enrolled"", 'patients with colorectal cancer and postoperative adjuvant chemotherapy', 'colorectal cancer patients with nutritional risk receiving postoperative adjuvant chemotherapy']","['Oral nutritional supplements', 'control group only received dietary guidance', 'dietary guidance and oral nutritional supplements (2092 kJ/day, whole protein enteral nutrition', 'oral nutritional supplementation (ONS', 'ONS', 'oral nutritional supplementation']","['quality of life', 'nutritional status and quality of life', 'body weight and BMI', 'body weight', 'Anthropometric measurements (body weight, body mass index [BMI', 'anthropometric measurements and nutrition-related laboratory tests', 'gastrointestinal function and quality of life', ' upper arm circumference, gripping power of the dominant hand, triceps skin fold), nutrition-related laboratory tests (hemoglobin, albumin, prealbumin, total cholesterol, triglyceride), gastrointestinal function scores and quality of life (evaluated by EuroQol five dimensions questionnaire']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C1268620', 'cui_str': 'At risk for nutritional problem'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205440', 'cui_str': 'Sixth'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0456646', 'cui_str': 'kJ/day'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0449722', 'cui_str': 'Dominant hand'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2733251', 'cui_str': 'EuroQoL five dimension questionnaire'}]",43.0,0.042548,No significant differences of other anthropometric measurements and nutrition-related laboratory tests were found between the two groups (all  P >0.05).,"[{'ForeName': 'X', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of General Surgery, Beijing Hospital, National Center of Gerontology, Beijing 100730, China.'}, {'ForeName': 'M W', 'Initials': 'MW', 'LastName': 'Zhu', 'Affiliation': 'Department of General Surgery, Beijing Hospital, National Center of Gerontology, Beijing 100730, China.'}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Xiu', 'Affiliation': 'Department of General Surgery, Peking University Third Hospital, Beijing 100191, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of General Surgery, Xinhua Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 200093, China.'}, {'ForeName': 'G X', 'Initials': 'GX', 'LastName': 'Yang', 'Affiliation': 'Department of General Surgery, Nanfang Hospital of Nanfang Medical University, Guangzhou, Guangdong 510920, China.'}, {'ForeName': 'W G', 'Initials': 'WG', 'LastName': 'Hu', 'Affiliation': 'Department of General Surgery, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 200025, China.'}, {'ForeName': 'Z G', 'Initials': 'ZG', 'LastName': 'Wang', 'Affiliation': ""Department of General Surgery, The Sixth People's Hospital Affiliated to Shanghai Jiaotong University, Shanghai 200233, China.""}, {'ForeName': 'H Y', 'Initials': 'HY', 'LastName': 'Cui', 'Affiliation': 'Department of General Surgery, Beijing Hospital, National Center of Gerontology, Beijing 100730, China.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Wei', 'Affiliation': 'Department of General Surgery, Beijing Hospital, National Center of Gerontology, Beijing 100730, China.'}]",Zhonghua wei chang wai ke za zhi = Chinese journal of gastrointestinal surgery,['10.3760/cma.j.cn.441530-20190724-00287']
2154,32521977,[Application of convolutional neural network to risk evaluation of positive circumferential resection margin of rectal cancer by magnetic resonance imaging].,"Objective:  To explore the feasibility of using faster regional convolutional neural network (Faster R-CNN) to evaluate the status of circumferential resection margin (CRM) of rectal cancer in the magnetic resonance imaging (MRI).  Methods:  This study was registered in the Chinese Clinical Trial Registry (ChiCTR-1800017410). Case inclusion criteria: (1) the positive area of CRM was located between the plane of the levator ani, anal canal and peritoneal reflection; (2) rectal malignancy was confirmed by electronic colonoscopy and histopathological examination; (3) positive CRM was confirmed by postoperative pathology or preoperative high-resolution MRI. Exclusion criteria: patients after neoadjuvant therapy, recurrent cancer after surgery, poor quality images, giant tumor with extensive necrosis and tissue degeneration, and rectal tissue construction changes in previous pelvic surgery. According to the above criteria, MRI plain scan images of 350 patients with rectal cancer and positive CRM in The Affiliated Hospital of Qingdao University from July 2016 to June 2019 were collected. The patients were classified by gender and tumor position, and randomly assigned to the training group (300 cases) and the validation group (50 cases) at a ratio of 6:1 by computer random number method. The CRM positive region was identified on the T2WI image using the LabelImg software. The identified training group images were used to iteratively train and optimize parameters of the Faster R-CNN model until the network converged to obtain the best deep learning model. The test set data were used to evaluate the recognition performance of the artificial intelligence platform. The selected indicators included accuracy, sensitivity, positive predictive value, receiver operating characteristic (ROC) curves, areas under the ROC curves (AUC), and the time taken to identify a single image.  Results:  The accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of the CRM status determined by the trained Faster R-CNN artificial intelligence approach were 0.884, 0.857, 0.898, 0.807, and 0.926, respectively; the AUC was 0.934 (95% CI: 91.3% to 95.4%). The Faster R-CNN model's automatic recognition time for a single image was 0.2 s.  Conclusion:  The artificial intelligence model based on Faster R-CNN for the identification and segmentation of CRM-positive MRI images of rectal cancer is established, which can complete the risk assessment of CRM-positive areas caused by  in-situ  tumor invasion and has the application value of preliminary screening.",2020,"The artificial intelligence model based on Faster R-CNN for the identification and segmentation of CRM-positive MRI images of rectal cancer is established, which can complete the risk assessment of CRM-positive areas caused by  in-situ  tumor invasion and has the application value of preliminary screening.","['350 patients with rectal cancer and positive CRM in The Affiliated Hospital of Qingdao University from July 2016 to June 2019 were collected', 'Exclusion criteria: patients after neoadjuvant therapy, recurrent cancer after surgery, poor quality images, giant tumor with extensive necrosis and tissue degeneration, and rectal tissue construction changes in previous pelvic surgery']","['faster regional convolutional neural network (Faster R-CNN', 'magnetic resonance imaging (MRI', 'convolutional neural network', 'magnetic resonance imaging']","['accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of the CRM status determined by the trained Faster R-CNN artificial intelligence approach', 'accuracy, sensitivity, positive predictive value, receiver operating characteristic (ROC) curves, areas under the ROC curves (AUC), and the time taken to identify a single image', ""Faster R-CNN model's automatic recognition time""]","[{'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0549379', 'cui_str': 'Recurrent cancer'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0017547', 'cui_str': 'Gigantism'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0403066', 'cui_str': 'Construction worker'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0242406', 'cui_str': 'Neural Networks (Anatomic)'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0035787', 'cui_str': 'ROC Analysis'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}]",350.0,0.035935,"The artificial intelligence model based on Faster R-CNN for the identification and segmentation of CRM-positive MRI images of rectal cancer is established, which can complete the risk assessment of CRM-positive areas caused by  in-situ  tumor invasion and has the application value of preliminary screening.","[{'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Xu', 'Affiliation': 'Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University, Qingdao, Shandong 266003, China.'}, {'ForeName': 'X M', 'Initials': 'XM', 'LastName': 'Zhou', 'Affiliation': 'Department of Radiology, Affiliated Hospital of Qingdao University, Qingdao, Shandong 266003, China.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Ma', 'Affiliation': 'Department of Radiology, Affiliated Hospital of Qingdao University, Qingdao, Shandong 266003, China.'}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Liu', 'Affiliation': 'Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University, Qingdao, Shandong 266003, China.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University, Qingdao, Shandong 266003, China.'}, {'ForeName': 'X F', 'Initials': 'XF', 'LastName': 'Zheng', 'Affiliation': 'Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University, Qingdao, Shandong 266003, China.'}, {'ForeName': 'X Y', 'Initials': 'XY', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University, Qingdao, Shandong 266003, China.'}, {'ForeName': 'G W', 'Initials': 'GW', 'LastName': 'Liu', 'Affiliation': 'Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University, Qingdao, Shandong 266003, China.'}, {'ForeName': 'X X', 'Initials': 'XX', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University, Qingdao, Shandong 266003, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Shandong Key Laboratory of Digital Medicine and Computer Assisted Surgery, Qingdao, Shandong 266003, China.'}, {'ForeName': 'D S', 'Initials': 'DS', 'LastName': 'Wang', 'Affiliation': 'Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University, Qingdao, Shandong 266003, China.'}]",Zhonghua wei chang wai ke za zhi = Chinese journal of gastrointestinal surgery,['10.3760/cma.j.cn.441530-20191023-00460']
2155,32522591,Mothers' DASH diet adherence and food purchases after week-long episodic future thinking intervention.,"Prospection has helped participants forego the temptation to buy and eat higher calorie nutrient poor foods in favor of buying and eating fewer calories and healthier macronutrient profiles in laboratory tasks and brief field studies. This pilot study examines whether episodic future thinking (EFT) improves mothers' dietary behavior and food purchasing over a longer 7-10-day period. The study utilized a 2 × 2 factorial design with mothers (N = 60) randomized to EFT or standardized episodic thinking (SET) crossed with dietary approaches to stop hypertension (DASH) diet education or a food safety education control. Participants listened to their cues (e.g., recordings of themselves imagining a future event or recalling a past episode) using a mobile ecological momentary intervention (EMI) tool and returned to complete a follow-up dietary recall and submit food receipts. Results showed diets of mothers in the EFT groups became more concordant with the DASH diet (η p 2  = 0.08, p < .05) than mothers in the SET group. When considering food purchases for the family, there was an EFT effect on milligrams of sodium purchased (η p 2  = 0.07, p < .05) and a trend towards a decrease in grams of fat purchased (η p 2  = 0.06, p = .06), however, these findings were no longer significant after correcting for multiple comparisons. There were no DASH education effects and no DASH by EFT interactions observed. The dietary intake and food purchasing results should be replicated in larger more representative samples.",2020,"Results showed diets of mothers in the EFT groups became more concordant with the DASH diet (η p 2  = 0.08, p < .05) than mothers in the SET group.",['2\u202f×\u202f2 factorial design with mothers (N\u202f=\u202f60) randomized to'],"['episodic future thinking (EFT', 'EFT or standardized episodic thinking (SET) crossed with dietary approaches to stop hypertension (DASH) diet education or a food safety education control', 'mobile ecological momentary intervention (EMI) tool and returned to complete a follow-up dietary recall and submit food receipts']","['DASH education effects', ""mothers' dietary behavior and food purchasing"", 'grams of fat purchased']","[{'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C1456535', 'cui_str': 'Food Safety'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]","[{'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]",60.0,0.0401892,"Results showed diets of mothers in the EFT groups became more concordant with the DASH diet (η p 2  = 0.08, p < .05) than mothers in the SET group.","[{'ForeName': 'Kelseanna', 'Initials': 'K', 'LastName': 'Hollis-Hansen', 'Affiliation': 'Department of Population Health, University of Texas at Austin, Dell Medical School, Austin, TX, USA; University of Texas at Austin, Steve Hicks School of Social Work, Austin, TX, USA. Electronic address: kelseanna.hollishansen@austin.utexas.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Seidman', 'Affiliation': 'Department of Pediatrics, Division of Behavioral Medicine, University at Buffalo, Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': ""O'Donnell"", 'Affiliation': 'Department of Pediatrics, Division of Behavioral Medicine, University at Buffalo, Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}, {'ForeName': 'Leonard H', 'Initials': 'LH', 'LastName': 'Epstein', 'Affiliation': 'Department of Pediatrics, Division of Behavioral Medicine, University at Buffalo, Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}]",Appetite,['10.1016/j.appet.2020.104757']
2156,32524499,"PF-06881894, a Proposed Biosimilar to Pegfilgrastim, Versus US-Licensed and EU-Approved Pegfilgrastim Reference Products (Neulasta ® ): Pharmacodynamics, Pharmacokinetics, Immunogenicity, and Safety of Single or Multiple Subcutaneous Doses in Healthy Volunteers.","INTRODUCTION


PF-06881894 is a proposed biosimilar to pegfilgrastim (Neulasta ® ). This study evaluated the pharmacodynamic/pharmacokinetic (PD/PK) equivalence, immunogenicity, and safety of PF-06881894 vs pegfilgrastim reference products (US- and EU-Neulasta ® ) in healthy volunteers.
METHODS


A phase 1, open-label, randomized, crossover study was conducted to assess the pharmacologic equivalence and safety of a single 6-mg dose of PF-06881894, pegfilgrastim-US, and pegfilgrastim-EU. The primary PD endpoints were area under the effect-versus-time curve for absolute neutrophil count (ANC) from dose administration to 288 h postdose, and maximum observed ANC value among subjects confirmed negative for anti-pegfilgrastim antibodies. Primary PK variables included area under the serum pegfilgrastim-versus-time curve from the time of dose administration to time infinity and maximum observed serum pegfilgrastim concentration. A second phase 1, open-label, randomized (1:1), parallel-group, non-inferiority study was conducted to assess the immunogenicity and safety of multiple 6-mg doses of PF-06881894 versus pegfilgrastim-US. The primary endpoint for the immunogenicity study was the proportion of subjects with both negative baseline and confirmed positive postdose anti-pegfilgrastim antibodies at any time during the study.
RESULTS


Across the single- and multiple-dose studies (N = 153 and N = 420 treated subjects, respectively), demographics for age (18-65 years), male gender (n = 264/573), and white race (n = 423/573) were similar. Three-way PD/PK equivalence of PF-06881894, pegfilgrastim-US, and pegfilgrastim-EU was demonstrated with the primary PD endpoints and primary PK variables being completely contained within the predefined 90% confidence interval acceptance limits (80-125%). The non-inferiority of PF-06881894 versus pegfilgrastim-US in terms of immunogenicity was established according to the prespecified non-inferiority margin (≤10%). Overall, there were no clinically meaningful differences in safety profiles among or between study groups.
CONCLUSIONS


Single-dose PF-06881894 demonstrated PD/PK equivalence and comparable safety with US- and EU-pegfilgrastim reference products. Multiple-dose PF-06881894 demonstrated immunogenicity non-inferiority to pegfilgrastim-US with comparable safety. Both studies contributed to the totality of evidence supporting biosimilarity.
TRIAL REGISTRATION


ClinicalTrials.gov identifiers: NCT02629289 (C1221001); NCT03273842 (C1221005).",2020,The non-inferiority of PF-06881894 versus pegfilgrastim-US in terms of immunogenicity was established according to the prespecified non-inferiority margin (≤10%).,"['Healthy Volunteers', '420 treated subjects, respectively), demographics for age (18-65\xa0years), male gender (n\u2009=\u2009264/573), and white race (n\u2009=\u2009423/573', 'healthy volunteers']","['PF-06881894 vs pegfilgrastim reference products (US- and EU-Neulasta ® ', 'pegfilgrastim-US', 'PF-06881894, pegfilgrastim-US, and pegfilgrastim-EU']","['area under the effect-versus-time curve for absolute neutrophil count (ANC', 'pharmacodynamic/pharmacokinetic (PD/PK) equivalence, immunogenicity, and safety', 'proportion of subjects with both negative baseline and confirmed positive postdose anti-pegfilgrastim antibodies', 'area under the serum pegfilgrastim-versus-time curve from the time of dose administration to time infinity and maximum observed serum pegfilgrastim concentration', 'pharmacologic equivalence and safety', 'PD/PK equivalence', 'immunogenicity and safety', 'confidence interval acceptance limits']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4517774', 'cui_str': '420'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C1171279', 'cui_str': 'Neulasta'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]",420.0,0.0810477,The non-inferiority of PF-06881894 versus pegfilgrastim-US in terms of immunogenicity was established according to the prespecified non-inferiority margin (≤10%).,"[{'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Moosavi', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Troy', 'Initials': 'T', 'LastName': 'Borema', 'Affiliation': 'Quotient Sciences, Miami, FL, USA.'}, {'ForeName': 'Reginald', 'Initials': 'R', 'LastName': 'Ewesuedo', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Harris', 'Affiliation': 'Quotient Sciences, Miami, FL, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Levy', 'Affiliation': 'Quotient Sciences, Miami, FL, USA.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'May', 'Affiliation': 'Pfizer Inc, Lake Forest, IL, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Summers', 'Affiliation': 'Pfizer Inc, San Diego, CA, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Thomas', 'Affiliation': 'Pfizer Inc, San Diego, CA, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Pfizer Inc, Lake Forest, IL, USA.'}, {'ForeName': 'Hsuan-Ming', 'Initials': 'HM', 'LastName': 'Yao', 'Affiliation': 'Pfizer Inc, Lake Forest, IL, USA. hsuan-ming.yao@pfizer.com.'}]",Advances in therapy,['10.1007/s12325-020-01387-x']
2157,32539805,"Stereotactic ablative body radiotherapy (SABR) combined with immunotherapy (L19-IL2) versus standard of care in stage IV NSCLC patients, ImmunoSABR: a multicentre, randomised controlled open-label phase II trial.","BACKGROUND


About 50% of non-small cell lung cancer (NSCLC) patients have metastatic disease at initial diagnosis, which limits their treatment options and, consequently, the 5-year survival rate (15%). Immune checkpoint inhibitors (ICI), either alone or in combination with chemotherapy, have become standard of care (SOC) for most good performance status patients. However, most patients will not obtain long-term benefit and new treatment strategies are therefore needed. We previously demonstrated clinical safety of the tumour-selective immunocytokine L19-IL2, consisting of the anti-ED-B scFv L19 antibody coupled to IL2, combined with stereotactic ablative radiotherapy (SABR).
METHODS


This investigator-initiated, multicentric, randomised controlled open-label phase II clinical trial will test the hypothesis that the combination of SABR and L19-IL2 increases progression free survival (PFS) in patients with limited metastatic NSCLC. One hundred twenty-six patients will be stratified according to their metastatic load (oligo-metastatic: ≤5 or poly-metastatic: 6 to 10) and randomised to the experimental-arm (E-arm) or the control-arm (C-arm). The C-arm will receive SOC, according to the local protocol. E-arm oligo-metastatic patients will receive SABR to all lesions followed by L19-IL2 therapy; radiotherapy for poly-metastatic patients consists of irradiation of one (symptomatic) to a maximum of 5 lesions (including ICI in both arms if this is the SOC). The accrual period will be 2.5-years, starting after the first centre is initiated and active. Primary endpoint is PFS at 1.5-years based on blinded radiological review, and secondary endpoints are overall survival, toxicity, quality of life and abscopal response. Associative biomarker studies, immune monitoring, CT-based radiomics, stool collection, iRECIST and tumour growth rate will be performed.
DISCUSSION


The combination of SABR with or without ICI and the immunocytokine L19-IL2 will be tested as 1st, 2nd or 3rd line treatment in stage IV NSCLC patients in 14 centres located in 6 countries. This bimodal and trimodal treatment approach is based on the direct cytotoxic effect of radiotherapy, the tumour selective immunocytokine L19-IL2, the abscopal effect observed distant from the irradiated metastatic site(s) and the memory effect. The first results are expected end 2023.
TRIAL REGISTRATION


ImmunoSABR Protocol Code: NL67629.068.18; EudraCT: 2018-002583-11; Clinicaltrials.gov: NCT03705403; ISRCTN ID: ISRCTN49817477; Date of registration: 03-April-2019.",2020,"We previously demonstrated clinical safety of the tumour-selective immunocytokine L19-IL2, consisting of the anti-ED-B scFv L19 antibody coupled to IL2, combined with stereotactic ablative radiotherapy (SABR).
","['stage IV NSCLC patients, ImmunoSABR', 'patients with limited metastatic NSCLC', 'One hundred twenty-six patients will be stratified according to their metastatic load (oligo-metastatic: ≤5 or poly-metastatic: 6 to 10', 'stage IV NSCLC patients in 14 centres located in 6 countries']","['stereotactic ablative radiotherapy (SABR', 'Stereotactic ablative body radiotherapy (SABR) combined with immunotherapy (L19-IL2', 'Immune checkpoint inhibitors (ICI), either alone or in combination with chemotherapy', 'SABR and L19-IL2', 'L19-IL2 therapy; radiotherapy']","['progression free survival (PFS', '5-year survival rate', 'PFS', 'overall survival, toxicity, quality of life and abscopal response']","[{'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0028953', 'cui_str': 'Oligonucleotide'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",126.0,0.209305,"We previously demonstrated clinical safety of the tumour-selective immunocytokine L19-IL2, consisting of the anti-ED-B scFv L19 antibody coupled to IL2, combined with stereotactic ablative radiotherapy (SABR).
","[{'ForeName': 'Relinde I Y', 'Initials': 'RIY', 'LastName': 'Lieverse', 'Affiliation': 'The D-Lab and The M-Lab, Department of Precision Medicine, GROW - School for Oncology and Developmental Biology, Maastricht University, Maastricht, The Netherlands. relinde.lieverse@maastrichtuniversity.nl.'}, {'ForeName': 'Evert J', 'Initials': 'EJ', 'LastName': 'Van Limbergen', 'Affiliation': 'Department of Radiation Oncology (MAASTRO), GROW - School for Oncology and Developmental Biology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Cary J G', 'Initials': 'CJG', 'LastName': 'Oberije', 'Affiliation': 'The D-Lab and The M-Lab, Department of Precision Medicine, GROW - School for Oncology and Developmental Biology, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Esther G C', 'Initials': 'EGC', 'LastName': 'Troost', 'Affiliation': 'Department of Radiotherapy and Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus at Technische Universität Dresden, Fetscherstrasse 74, 01307, Dresden, Germany.'}, {'ForeName': 'Sine R', 'Initials': 'SR', 'LastName': 'Hadrup', 'Affiliation': 'Department of Health Technology, Technical University of Denmark, Kongens Lyngby, Denmark.'}, {'ForeName': 'Anne-Marie C', 'Initials': 'AC', 'LastName': 'Dingemans', 'Affiliation': 'Department of Pulmonary Medicine, Erasmus MC Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Lizza E L', 'Initials': 'LEL', 'LastName': 'Hendriks', 'Affiliation': 'Department of Pulmonary Diseases, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Eckert', 'Affiliation': 'Department of Radiation Oncology, University Hospital and Medical Faculty Tübingen, Eberhard Karls University Tübingen, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany.'}, {'ForeName': 'Crispin', 'Initials': 'C', 'LastName': 'Hiley', 'Affiliation': ""Cancer Research UK Lung Cancer Centre of Excellence, University College London Cancer Institute, Paul O'Gorman Building, 72 Huntley Street, London, WC1E 6DD, UK.""}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Dooms', 'Affiliation': 'Department of Respiratory Diseases, Respiratory Oncology Unit, University Hospitals KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Yolande', 'Initials': 'Y', 'LastName': 'Lievens', 'Affiliation': 'Department of Radiation Oncology, Ghent University Hospital and Ghent University, Ghent, Belgium.'}, {'ForeName': 'Monique C', 'Initials': 'MC', 'LastName': 'de Jong', 'Affiliation': 'Department of Radiation Oncology, Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066, Amsterdam, CX, The Netherlands.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Bussink', 'Affiliation': 'Department of Radiation Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Geets', 'Affiliation': 'Department of Radiation Oncology, Cliniques Universitaires Saint-Luc, MIRO - IREC Lab, UCL, Bruxelles, Belgium.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Valentini', 'Affiliation': 'Dipartimento Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy.'}, {'ForeName': 'Giuliano', 'Initials': 'G', 'LastName': 'Elia', 'Affiliation': 'Philochem AG, Libernstrasse 3, CH-8112, Otelfingen, Switzerland.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Neri', 'Affiliation': 'Department of Chemistry and Applied Biosciences, Institute of Pharmaceutical Sciences, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Billiet', 'Affiliation': 'Department of Radiation Oncology, Iridium\u202fNetwork, Wilrijk\u202f(Antwerp), Belgium.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Abdollahi', 'Affiliation': 'Division of Molecular and Translational Radiation Oncology, Department of Radiation Oncology, Heidelberg Faculty of Medicine (MFHD) and Heidelberg University Hospital (UKHD), Heidelberg Ion-Beam Therapy Center (HIT), 69120 Heidelberg, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pasquier', 'Affiliation': 'Academic Department of Radiation Oncology, Oscar Lambret Comprehensive Cancer Center, Lille, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Boisselier', 'Affiliation': ""Department of Radiation Oncology, ICM-Val d'Aurelle, Université de Montpellier, Montpellier, France.""}, {'ForeName': 'Ala', 'Initials': 'A', 'LastName': 'Yaromina', 'Affiliation': 'The D-Lab and The M-Lab, Department of Precision Medicine, GROW - School for Oncology and Developmental Biology, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'De Ruysscher', 'Affiliation': 'Department of Radiation Oncology (MAASTRO), GROW - School for Oncology and Developmental Biology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Ludwig J', 'Initials': 'LJ', 'LastName': 'Dubois', 'Affiliation': 'The D-Lab and The M-Lab, Department of Precision Medicine, GROW - School for Oncology and Developmental Biology, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Lambin', 'Affiliation': 'The D-Lab and The M-Lab, Department of Precision Medicine, GROW - School for Oncology and Developmental Biology, Maastricht University, Maastricht, The Netherlands.'}]",BMC cancer,['10.1186/s12885-020-07055-1']
2158,32539810,"Study rationale and design of the EANITIATE study (EmpAgliflozin compared to NPH Insulin for sTeroId diAbeTEs) - a randomized, controlled, multicenter trial of safety and efficacy of treatment with empagliflozin compared with NPH-insulin in patients with newly onset diabetes following initiation of glucocorticoid treatment.","BACKGROUND


A well-known metabolic side effect from treatment with glucocorticoids is glucocorticoid-induced diabetes mellitus (GIDM). Guidelines on the management of GIDM in hospitalized patients (in the non-critical care setting), recommend initiation of insulin therapy. The scientific basis and evidence for superiority of insulin therapy over other glucose lowering therapies is however poor and associated with episodes of both hypo- and hyperglycaemia. There is an unmet need for an easier, safe and convenient therapy for glucocorticoid-induced diabetes.
METHODS


EANITIATE is a Danish, open, prospective, multicenter, randomized (1:1), parallel group study in patients with new-onset diabetes following treatment with glucocorticoids (> 20 mg equivalent prednisolone dose/day) with blinded endpoint evaluation (PROBE design). Included patients are randomized to either a Sodium-Glucose-Cotransporter 2 (SGLT2) inhibitor or neutral protamin Hagedorn (NPH) insulin and followed for 30 days. Blinded continuous glucose monitoring (CGM) will provide data for the primary endpoint (mean daily blood glucose) and on glucose fluctuations in the two treatment arms. Secondary endpoints are patient related outcomes, hypoglycaemia, means and measures of variation for all values and for time specific glucose values. This is a non-inferiority study with the intent to demonstrate that treatment with empagliflozin is not inferior to treatment with NPH insulin when it comes to glycemic control and side effects.
DISCUSSION


This novel approach to management of glucocorticoid-induced hyperglycemia has not been tested before and if SGLT2 inhibition with empaglifozin compared to NPH-insulin is a safe, effective and resource sparing treatment for GIDM, it has the potential to improve the situation for affected patients and have health economic benefits.
TRIAL REGISTRATION


www.clinicaltrialsregister.eu no.: 2018-002640-82. Prospectively registered November 20th. 2018. Date of first patient enrolled: June 4th. 2019. This protocol article is based on the EANITATE protocol version 1.3, dated 29. January 2018.",2020,"Secondary endpoints are patient related outcomes, hypoglycaemia, means and measures of variation for all values and for time specific glucose values.","['patients with newly onset diabetes following initiation of glucocorticoid treatment', ' 2018-002640-82', 'dose/day) with blinded endpoint evaluation (PROBE design', 'hospitalized patients', 'patients with new-onset diabetes following treatment with']","['EmpAgliflozin', 'continuous glucose monitoring (CGM', 'Sodium-Glucose-Cotransporter 2 (SGLT2) inhibitor or neutral protamin Hagedorn (NPH) insulin and followed for 30\u2009days', 'empagliflozin', 'empaglifozin', 'NPH Insulin', 'glucocorticoids (>\u200920\u2009mg equivalent prednisolone', 'glucocorticoids', 'NPH-insulin']","['glucose fluctuations', 'patient related outcomes, hypoglycaemia, means and measures of variation for all values and for time specific glucose values']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",,0.0758112,"Secondary endpoints are patient related outcomes, hypoglycaemia, means and measures of variation for all values and for time specific glucose values.","[{'ForeName': 'Carina Kirstine', 'Initials': 'CK', 'LastName': 'Klarskov', 'Affiliation': 'Department of Endocrinology and Nephrology, Nordsjaellands Hospital, Dyrehavevej 29, DK-3400, Hilleroed, Denmark. Carina.kirstine.klarskov@regionh.dk.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Holm Schultz', 'Affiliation': 'Department of Oncology at Herlev-Gentofte University Hospital, Herlev Ringvej 75, DK-2730, Herlev, Denmark.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Persson', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens vej 2, DK-2820, Gentofte, Denmark.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Møller Christensen', 'Affiliation': 'Department of Endocrinology, Bispebjerg University Hospital, Bispebjergbakke 23, DK-2400, Copenhagen, Denmark.'}, {'ForeName': 'Thomas Peter', 'Initials': 'TP', 'LastName': 'Almdal', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital (Rigshospitalet), Blegdamsvej 9, DK-2100, Copenhagen, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Snorgaard', 'Affiliation': 'Hvidovre University Hospital, Kettegård Alle 30, DK-2650, Hvidovre, Denmark.'}, {'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Bagge Hansen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens vej 2, DK-2820, Gentofte, Denmark.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Pedersen-Bjergaard', 'Affiliation': 'Department of Endocrinology and Nephrology, Nordsjaellands Hospital, Dyrehavevej 29, DK-3400, Hilleroed, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lommer Kristensen', 'Affiliation': 'Department of Endocrinology and Nephrology, Nordsjaellands Hospital, Dyrehavevej 29, DK-3400, Hilleroed, Denmark.'}]",BMC endocrine disorders,['10.1186/s12902-020-00561-0']
2159,32539812,Effects of transcranial direct current stimulation with virtual reality on upper limb function in patients with ischemic stroke: a randomized controlled trial.,"BACKGROUND


Non-invasive brain stimulation techniques have been shown in several studies to improve the motor recovery of the affected upper-limbs in stroke patients. This study aims to investigate whether or not cathodal transcranial direct current stimulation (c-tDCS), combined with virtual reality (VR), is superior to VR alone in reducing motor impairment and improving upper limb function and quality of life in stroke patients.
METHODS


Forty patients who suffered ischemic stroke between 2 weeks to 12 months were recruited for this single-blind randomized control trial. The patients were randomly assigned either to an experimental group who receiving c-tDCS and VR, or a control group receiving sham stimulation and VR. The cathodal electrode was positioned over the primary motor cortex (M1) of the unaffected hemisphere. The treatment session consisted of 20 min of daily therapy, for 10 sessions over a 2-week period. The outcome measures were the Fugl-Meyer Upper Extremity (FM-UE), the Action Research Arm Test (ARAT) and the Barthel Index (BI).
RESULTS


The two groups were comparable in demographic characteristic and motor impairment. After 2 weeks of intervention, both groups demonstrated significant improvement in FM-UE, ARAT and BI scores (P<0.05).The experiment group demonstrated more improvement in FM-UE than the control group (10.1 vs. 6.4, p = 0.003) and, ARAT (7.0 vs 3.6, p = 0.026) and BI (12.8 vs 8.5, p = 0.043).
CONCLUSIONS


The findings from our study support that c-tDCS, along with VR, can facilitate a stronger beneficial effect on upper limb motor impairment, function and quality of life than VR alone in patients with ischemic stroke.
TRIAL REGISTRATION


The study was registered in the Chinese Clinical Trial Registry (ChiCTR1800019386) in November 8, 2018-Retrospectively registered.",2020,"After 2 weeks of intervention, both groups demonstrated significant improvement in FM-UE, ARAT and BI scores (P<0.05).The experiment group demonstrated more improvement in FM-UE than the control group (10.1 vs. 6.4, p = 0.003) and, ARAT (7.0 vs 3.6, p = 0.026) and BI (12.8 vs 8.5, p = 0.043).
","['stroke patients', 'patients with ischemic stroke', 'Forty patients who suffered ischemic stroke between 2\u2009weeks to 12\u2009months']","['cathodal transcranial direct current stimulation (c-tDCS), combined with virtual reality (VR', 'experimental group who receiving c-tDCS and VR, or a control group receiving sham stimulation and VR', 'transcranial direct current stimulation with virtual reality']","['ARAT', 'FM-UE', 'demographic characteristic and motor impairment', 'FM-UE, ARAT and BI scores', 'upper limb motor impairment, function and quality of life', 'Fugl-Meyer Upper Extremity (FM-UE), the Action Research Arm Test (ARAT) and the Barthel Index (BI', 'motor impairment and improving upper limb function and quality of life']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C4720875', 'cui_str': 'Action research arm test'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",40.0,0.105452,"After 2 weeks of intervention, both groups demonstrated significant improvement in FM-UE, ARAT and BI scores (P<0.05).The experiment group demonstrated more improvement in FM-UE than the control group (10.1 vs. 6.4, p = 0.003) and, ARAT (7.0 vs 3.6, p = 0.026) and BI (12.8 vs 8.5, p = 0.043).
","[{'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Yao', 'Affiliation': 'Department of Rehabilitation Medicine, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Cui', 'Affiliation': 'Department of Rehabilitation Medicine, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Jixian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Wuwei', 'Initials': 'W', 'LastName': 'Feng', 'Affiliation': 'Deparment of Neurology, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Bao', 'Affiliation': 'Department of Rehabilitation Medicine, Shanghai Ruijin Rehabilitation Hospital, Shanghai, China. 15901999958@163.com.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Xie', 'Affiliation': 'Department of Rehabilitation Medicine, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China. ruijin_xq@163.com.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00699-x']
2160,32539850,"Efficacy, safety, and economic assessment of hominis placental pharmacopuncture for chronic temporomandibular disorder: a protocol for a multicentre randomised controlled trial.","BACKGROUND


Temporomandibular disorder (TMD) is a condition encompassing clinical symptoms of the temporomandibular joint, masseter muscle, and surrounding structures. Hominis placental pharmacopuncture (HPP), consisting of human placental extract, has been reported as effective for treating chronic musculoskeletal disorders, but a lack of well-designed randomised controlled trial s (RCTs) mean there is insufficient evidence to prove the efficacy of HPP.
METHODS


This study is a two-arm parallel, assessor-blinded, multi-centre, randomised controlled trial. We will enrol 82 chronic TMD patients from rwo Korean Medicine hospitals in Axis 1, Group I according to RDC/TMD diagnostic criteria, and randomly allocate 41 patients each to an HPP group and a physical therapy (PT) group. Treatment will be administered in 10 rounds, after which there will be four follow-up visits 6, 9, 13, and 25 weeks from baseline. The primary end point is 6 weeks after baseline, and the primary outcome is the difference in Visual Analogue Scale (VAS) score for temporomandibular pain between baseline and week 6. Secondary outcomes will be Numeric Rating Scale (NRS) scores for temporomandibular pain and discomfort, temporomandibular joint range of motion, the Korean version of Beck's Depression Index-II (K-BDI-II), Jaw Functional Limitation Scale (JFLS), Patient Global Impression of Change (PGIC) scores, and quality of life. Using data on adverse events and cost-effectiveness in the two groups, we will perform a safety assessment and a cost-effectiveness analysis (economic assessment).
DISCUSSION


This study will assess the efficacy and safety of HPP for chronic TMD compared with PT. This RCT will provide evidence for the efficacy, safety, and economics of HPP.
TRIAL REGISTRATION


clinicaTrials.gov (NCT04087005) / Clinical Research Information Service (CRIS) (KCT0004437) / IRB (JASENG 2017-09-002-002, KHNMCOH 2019-08-002) / Ministry of Food and Drug Safety (No. 31886).",2020,"The primary end point is 6 weeks after baseline, and the primary outcome is the difference in Visual Analogue Scale (VAS) score for temporomandibular pain between baseline and week 6.","['82 chronic TMD patients from rwo Korean Medicine hospitals in Axis 1, Group I according to RDC/TMD diagnostic criteria, and randomly allocate 41 patients each to an', 'chronic temporomandibular disorder']","['hominis placental pharmacopuncture', 'HPP', 'Hominis placental pharmacopuncture (HPP), consisting of human placental extract', 'HPP group and a physical therapy (PT']","['Visual Analogue Scale (VAS) score for temporomandibular pain', 'adverse events and cost-effectiveness', 'Ministry of Food and Drug Safety', ""Numeric Rating Scale (NRS) scores for temporomandibular pain and discomfort, temporomandibular joint range of motion, the Korean version of Beck's Depression Index-II (K-BDI-II), Jaw Functional Limitation Scale (JFLS), Patient Global Impression of Change (PGIC) scores, and quality of life"", 'Efficacy, safety, and economic assessment']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0207800', 'cui_str': 'monorden'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0458975', 'cui_str': 'Hominy'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C4279921', 'cui_str': 'Pharmacopuncture'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0032048', 'cui_str': 'Placental Extracts'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0039493', 'cui_str': 'Temporomandibular joint structure'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",82.0,0.358427,"The primary end point is 6 weeks after baseline, and the primary outcome is the difference in Visual Analogue Scale (VAS) score for temporomandibular pain between baseline and week 6.","[{'ForeName': 'Jongho', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Jaseng Hospital of Korean Medicine, 536 Gangnam-daero, Gangnamgu, Seoul, Republic of Korea.'}, {'ForeName': 'Kyoung Sun', 'Initials': 'KS', 'LastName': 'Park', 'Affiliation': 'Jaseng Hospital of Korean Medicine, 536 Gangnam-daero, Gangnamgu, Seoul, Republic of Korea.'}, {'ForeName': 'Yoon Jae', 'Initials': 'YJ', 'LastName': 'Lee', 'Affiliation': 'Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, 3F JS Tower, 538 Gangnam-daero, Gangnam-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Koh-Woon', 'Initials': 'KW', 'LastName': 'Kim', 'Affiliation': 'Kyung Hee University Hospital at Gangdong, 892 Dongnam-ro, Gangdong-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Jae-Heung', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': 'Kyung Hee University Hospital at Gangdong, 892 Dongnam-ro, Gangdong-gu, Seoul, Republic of Korea.'}, {'ForeName': 'In-Hyuk', 'Initials': 'IH', 'LastName': 'Ha', 'Affiliation': 'Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, 3F JS Tower, 538 Gangnam-daero, Gangnam-gu, Seoul, Republic of Korea. hanihata@gmail.com.'}]",Trials,['10.1186/s13063-020-04442-8']
2161,32539853,Opportunistic treatment of hepatitis C virus infection (OPPORTUNI-C): study protocol for a pragmatic stepped wedge cluster randomized trial of immediate versus outpatient treatment initiation among hospitalized people who inject drugs.,"BACKGROUND


Scaled-up direct-acting antiviral (DAA) treatment of hepatitis C virus (HCV) infection among people who inject drugs (PWID) is crucial to reach the World Health Organization HCV elimination targets within 2030. One of the critical obstacles to HCV care in this population is the lack of treatment models within specialist healthcare adapted to marginalized individuals.
METHODS


OPPORTUNI-C is a pragmatic stepped wedge cluster randomized trial comparing the efficacy of immediate initiation of HCV treatment with the current standard of care among PWID admitted for inpatient care. Screening for HCV RNA will be performed as soon as possible after admission. The intervention includes immediate non-invasive liver disease assessment, counseling, and initiation of pan-genotypic DAA treatment with individualized follow-up. Standard of care is a referral to outpatient care at discharge. To mimic usual clinical practice as closely as possible, we will use a pragmatic clinical trial approach utilizing clinical infrastructure, broad eligibility criteria, flexible intervention delivery, clinically relevant outcomes, and collection of data readily available from the electronic patient files. The stepped wedge design involves a sequential rollout of the intervention over 16 months, in which seven participating clusters will be randomized from standard of care to intervention in a stepwise manner. Randomization will be stratified according to cluster size to keep high prevalence clusters separated. The trial will include approximately 220 HCV RNA positive individuals recruited from departments of internal medicine, addiction medicine, and psychiatry at Akershus University Hospital, Oslo University Hospital, and Lovisenberg Diaconal Hospital, Oslo, Norway. Individuals not able or willing to give informed consent and those with ongoing HCV assessment or treatment will be excluded. The primary outcome is treatment completion, defined as dispensing of the final prescribed DAA package from the pharmacy within 6 months after inclusion. Secondary outcomes include treatment uptake, virologic response, reinfection incidence, and resistance-associated substitutions.
DISCUSSION


Representing a novel model of care suited to reach and engage marginalized PWID in HCV care, this study will inform HCV elimination efforts locally and internationally. If the model proves efficacious and feasible, it should be considered for broader implementation, replacing the current standard of care.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT04220645. Registered on 7 January 2020.",2020,"METHODS


OPPORTUNI-C is a pragmatic stepped wedge cluster randomized trial comparing the efficacy of immediate initiation of HCV treatment with the current standard of care among PWID admitted for inpatient care.","['hospitalized people who inject drugs', '220 HCV RNA positive individuals recruited from departments of internal medicine, addiction medicine, and psychiatry at Akershus University Hospital, Oslo University Hospital, and Lovisenberg Diaconal Hospital, Oslo, Norway', 'people who inject drugs (PWID', 'care among PWID admitted for inpatient care']","['immediate non-invasive liver disease assessment, counseling, and initiation of pan-genotypic DAA treatment with individualized follow-up', 'HCV', 'Scaled-up direct-acting antiviral (DAA']","['treatment uptake, virologic response, reinfection incidence, and resistance-associated substitutions', 'treatment completion, defined as dispensing of the final prescribed DAA package']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0369335', 'cui_str': 'Hepatitis C virus RNA'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C4505067', 'cui_str': 'Addiction Medicine'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0030266', 'cui_str': 'Panama'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C2363964', 'cui_str': 'Antiviral treatment'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3653501', 'cui_str': 'DIRECT ACTING ANTIVIRALS'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0205339', 'cui_str': 'Reinfection'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0580352', 'cui_str': 'Treatment completed'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}]",,0.163486,"METHODS


OPPORTUNI-C is a pragmatic stepped wedge cluster randomized trial comparing the efficacy of immediate initiation of HCV treatment with the current standard of care among PWID admitted for inpatient care.","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Midgard', 'Affiliation': 'Department of Infectious Diseases, Akershus University Hospital, Lørenskog, Norway. havardmi@gmail.com.'}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Finbråten', 'Affiliation': 'Department of Medicine, Lovisenberg Diaconal Hospital, Oslo, Norway.'}, {'ForeName': 'K B', 'Initials': 'KB', 'LastName': 'Malme', 'Affiliation': 'Department of Infectious Diseases, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Berg-Pedersen', 'Affiliation': 'Department of Illicit drug use, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Tanum', 'Affiliation': 'Department for Research and Development in Mental Health, Akershus University Hospital, Nordbyhagen, Norway.'}, {'ForeName': 'I C', 'Initials': 'IC', 'LastName': 'Olsen', 'Affiliation': 'Department of Research Support for Clinical Trials, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bjørnestad', 'Affiliation': 'ProLAR Nett, Søgne, Norway.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Dalgard', 'Affiliation': 'Department of Infectious Diseases, Akershus University Hospital, Lørenskog, Norway.'}]",Trials,['10.1186/s13063-020-04434-8']
2162,32539883,Long-term behavioural rewriting of maladaptive drinking memories  via  reconsolidation-update mechanisms.,"BACKGROUND


Alcohol use disorders can be conceptualised as a learned pattern of maladaptive alcohol-consumption behaviours. The memories encoding these behaviours centrally contribute to long-term excessive alcohol consumption and are therefore an important therapeutic target. The transient period of memory instability sparked during memory reconsolidation offers a therapeutic window to directly rewrite these memories using targeted behavioural interventions. However, clinically-relevant demonstrations of the efficacy of this approach are few. We examined key retrieval parameters for destabilising naturalistic drinking memories and the ability of subsequent counterconditioning to effect long-term reductions in drinking.
METHODS


Hazardous/harmful beer-drinking volunteers (N = 120) were factorially randomised to retrieve (RET) or not retrieve (No RET) alcohol reward memories with (PE) or without (No PE) alcohol reward prediction error. All participants subsequently underwent disgust-based counterconditioning of drinking cues. Acute responses to alcohol were assessed pre- and post-manipulation and drinking levels were assessed up to 9 months.
RESULTS


Greater long-term reductions in drinking were found when counterconditioning was conducted following retrieval (with and without PE), despite a lack of short-term group differences in motivational responding to acute alcohol. Large variability in acute levels of learning during counterconditioning was noted. 'Responsiveness' to counterconditioning predicted subsequent responses to acute alcohol in RET + PE only, consistent with reconsolidation-update mechanisms.
CONCLUSIONS


The longevity of behavioural interventions designed to reduce problematic drinking levels may be enhanced by leveraging reconsolidation-update mechanisms to rewrite maladaptive memory. However, inter-individual variability in levels of corrective learning is likely to determine the efficacy of reconsolidation-updating interventions and should be considered when designing and assessing interventions.",2020,"RESULTS


Greater long-term reductions in drinking were found when counterconditioning was conducted following retrieval (with and without PE), despite a lack of short-term group differences in motivational responding to acute alcohol.",['Hazardous/harmful beer-drinking volunteers (N = 120'],['retrieve (RET) or not retrieve (No RET) alcohol reward memories with (PE) or without (No PE) alcohol reward prediction error'],['pre- and post-manipulation and drinking levels'],"[{'cui': 'C0004922', 'cui_str': 'Beer'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",120.0,0.0304084,"RESULTS


Greater long-term reductions in drinking were found when counterconditioning was conducted following retrieval (with and without PE), despite a lack of short-term group differences in motivational responding to acute alcohol.","[{'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Gale', 'Affiliation': 'Clinical, Educational and Health Psychology, UCL, 26 Bedford Way, LondonWC1H 0AP, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Walsh', 'Affiliation': 'Clinical, Educational and Health Psychology, UCL, 26 Bedford Way, LondonWC1H 0AP, UK.'}, {'ForeName': 'Vanessa E', 'Initials': 'VE', 'LastName': 'Hennessy', 'Affiliation': 'Clinical, Educational and Health Psychology, UCL, 26 Bedford Way, LondonWC1H 0AP, UK.'}, {'ForeName': 'L E', 'Initials': 'LE', 'LastName': 'Stemerding', 'Affiliation': 'Clinical, Educational and Health Psychology, UCL, 26 Bedford Way, LondonWC1H 0AP, UK.'}, {'ForeName': 'Koa Sher', 'Initials': 'KS', 'LastName': 'Ni', 'Affiliation': 'Clinical, Educational and Health Psychology, UCL, 26 Bedford Way, LondonWC1H 0AP, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Thomas', 'Affiliation': 'Clinical, Educational and Health Psychology, UCL, 26 Bedford Way, LondonWC1H 0AP, UK.'}, {'ForeName': 'Sunjeev K', 'Initials': 'SK', 'LastName': 'Kamboj', 'Affiliation': 'Clinical, Educational and Health Psychology, UCL, 26 Bedford Way, LondonWC1H 0AP, UK.'}, {'ForeName': 'Ravi K', 'Initials': 'RK', 'LastName': 'Das', 'Affiliation': 'Clinical, Educational and Health Psychology, UCL, 26 Bedford Way, LondonWC1H 0AP, UK.'}]",Psychological medicine,['10.1017/S0033291720001531']
2163,32539907,Implementing shared decision-making on acute psychiatric wards: a cluster-randomized trial with inpatients suffering from schizophrenia (SDM-PLUS).,"AIMS


Although shared decision-making (SDM) has the potential to improve health outcomes, psychiatrists often exclude patients with more severe mental illnesses or more acute conditions from participation in treatment decisions. This study examines whether SDM is facilitated by an approach which is specifically adapted to the needs of acutely ill patients (SDM-PLUS).
METHODS


The study is a multi-centre, cluster-randomised, non-blinded, controlled trial of SDM-PLUS in 12 acute psychiatric wards of five psychiatric hospitals addressing inpatients with schizophrenia or schizoaffective disorder. All patients fulfilling the inclusion criteria were consecutively recruited for the trial at the time of their admission to the ward. Treatment teams of intervention wards were trained in the SDM-PLUS approach through participation in two half-day workshops. Patients on intervention wards received group training in SDM. Staff (and patients) of the control wards acted under 'treatment as usual' conditions. The primary outcome parameter was the patients' perceived involvement in decision-making at 3 weeks after study enrolment, analysed using a random-effects linear regression model.
RESULTS


In total, 161 participants each were recruited in the intervention and control group. SDM-PLUS led to higher perceived involvement in decision-making (primary outcome, analysed patients n = 257, mean group difference 16.5, 95% CI 9.0-24.0, p = 0.002, adjusted for baseline differences: β 17.3, 95% CI 10.8-23.6, p = 0.0004). In addition, intervention group patients exhibited better therapeutic alliance, treatment satisfaction and self-rated medication compliance during inpatient stay. There were, however, no significant improvements in adherence and rehospitalisation rates in the 6- and 12-month follow-up.
CONCLUSIONS


Despite limitations in patient recruitment, the SDM-PLUS trial has shown that the adoption of behavioural approaches (e.g. motivational interviewing) for SDM may yield a successful application to mental health. The authors recommend strategies to ensure effects are not lost at the interface between in- and outpatient treatment.Trial registration: The trial was registered at Deutsches Register Klinischer Studien (DRKS00010880).",2020,"There were, however, no significant improvements in adherence and rehospitalisation rates in the 6- and 12-month follow-up.
","['inpatients suffering from schizophrenia (SDM-PLUS', '12 acute psychiatric wards of five psychiatric hospitals addressing inpatients with schizophrenia or schizoaffective disorder', '161 participants each were recruited in the intervention and control group', 'acutely ill patients (SDM-PLUS', 'All patients fulfilling the inclusion criteria were consecutively recruited for the trial at the time of their admission to the ward']","['SDM', 'group training in SDM', 'SDM-PLUS']","['adherence and rehospitalisation rates', 'therapeutic alliance, treatment satisfaction and self-rated medication compliance', ""patients' perceived involvement in decision-making""]","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0020021', 'cui_str': 'Psychiatric hospital'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0814487', 'cui_str': 'Therapeutic Alliance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}]",161.0,0.200858,"There were, however, no significant improvements in adherence and rehospitalisation rates in the 6- and 12-month follow-up.
","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hamann', 'Affiliation': 'Klinik und Poliklinik für Psychiatrie und Psychotherapie, Technische Universität München, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Holzhüter', 'Affiliation': 'Klinik und Poliklinik für Psychiatrie und Psychotherapie, Technische Universität München, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Blakaj', 'Affiliation': 'Isar-Amper-Klinikum München Ost, Haar, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Becher', 'Affiliation': 'Klinik und Poliklinik für Psychiatrie und Psychotherapie, Technische Universität München, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Haller', 'Affiliation': 'Institut für Medizinische Informatik, Statistik und Epidemiologie, Technische Universität München, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Landgrebe', 'Affiliation': 'Lech Mangfall Klinikum, Agatharied, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schmauß', 'Affiliation': 'Bezirkskrankenhaus Augsburg, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Heres', 'Affiliation': 'Isar-Amper-Klinikum München Ost, Haar, Germany.'}]",Epidemiology and psychiatric sciences,['10.1017/S2045796020000505']
2164,32540179,Comparing the usefulness of a fluoroscopic navigation system in femoral trochanteric fracture for orthopaedic residents with the conventional method.,"INTRODUCTION


Lag screw insertion into the ideal position is essential to obtain good results in open reduction and internal fixation for femoral trochanteric fracture. Tip-apex distance (TAD) is a widely adopted method for evaluating the risk of lag screw cut-out. Adaptive positioning technology (ADAPT) is a fluoroscopic computer-assisted surgery system that enables orthopaedic surgeons to guide the screw into a proper position intraoperatively. A randomized control study concluded that ADAPT resulted in excellent TAD. However, it was not significantly better than conventional methods when performed by fellowship-trained traumatologists. Therefore, we hypothesised that ADAPT would be useful to orthopaedic residents and evaluated this usefulness.
METHODS


We reviewed 102 patients who underwent open reduction and internal fixation for femoral trochanteric fracture from May 2017 to March 2019 using Gamma-3 intertrochanteric nails. Two residents performed all procedures; 51 patients underwent surgery using ADAPT and the others underwent surgery without navigation. The number of attempts to drill guide-wire, operation time, lag screw insertion time, radiation exposure time, TAD, and lag screw position were evaluated for each surgeon.
RESULTS


In one resident, when using the ADAPT system, the number of attempts to drill guide-wire (p=0.001), lag screw insertion time (p=0.000), radiational exposure time (p=0.009) and TAD (p=0.007) were lower, and the percentage of ideal lag screw position (p=0.035) were better than that in the conventional method. However, there was no significant difference in the performance of another resident with respect to the aforementioned factors, whether using ADAPT or not.
CONCLUSION


One resident showed better results with the ADAPT system than with conventional osteosynthesis. However, another resident received no benefit from ADAPT. The efficiency may not apply to everyone as individual competence can influence efficiency when using ADAPT system. Therefore, as a new device, it must be used cautiously because skill or experience may influence its use, especially by orthopaedic residents.",2020,Adaptive positioning technology (ADAPT) is a fluoroscopic computer-assisted surgery system that enables orthopaedic surgeons to guide the screw into a proper position intraoperatively.,"['102 patients who underwent open reduction and internal fixation for femoral trochanteric fracture from May 2017 to March 2019 using Gamma-3 intertrochanteric nails', 'femoral trochanteric fracture for orthopaedic residents with the conventional method']","['surgery using ADAPT and the others underwent surgery without navigation', 'conventional osteosynthesis', 'fluoroscopic navigation system', 'Tip-apex distance (TAD', 'Adaptive positioning technology (ADAPT']","['radiational exposure time', 'number of attempts to drill guide-wire, operation time, lag screw insertion time, radiation exposure time, TAD, and lag screw position', 'excellent TAD', 'percentage of ideal lag screw position', 'lag screw insertion time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0185373', 'cui_str': 'Open reduction of fracture'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0162387', 'cui_str': 'Trochanteric Fractures'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C4075648', 'cui_str': 'Navigation system'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0140145', 'cui_str': 'APEX1 protein, human'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0324815', 'cui_str': 'Mandrillus leucophaeus'}, {'cui': 'C0181089', 'cui_str': 'Guide wire'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0140145', 'cui_str': 'APEX1 protein, human'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",102.0,0.0170369,Adaptive positioning technology (ADAPT) is a fluoroscopic computer-assisted surgery system that enables orthopaedic surgeons to guide the screw into a proper position intraoperatively.,"[{'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Takai', 'Affiliation': 'Department of Orthopaedic Surgery, Kumamoto Kinoh Hospital, Kumamoto, Japan. Electronic address: hirokazoid@hotmail.co.jp.'}, {'ForeName': 'Kazutaka', 'Initials': 'K', 'LastName': 'Mizuta', 'Affiliation': 'Department of Orthopaedic Surgery, Kumamoto Kinoh Hospital, Kumamoto, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Murayama', 'Affiliation': 'Department of Orthopaedic Surgery, Kumamoto Kinoh Hospital, Kumamoto, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Nakayama', 'Affiliation': 'Department of Orthopaedic Surgery, Kumamoto Kinoh Hospital, Kumamoto, Japan.'}, {'ForeName': 'Sakumo', 'Initials': 'S', 'LastName': 'Kii', 'Affiliation': 'Department of Orthopaedic Surgery, Kumamoto Kinoh Hospital, Kumamoto, Japan.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Hayai', 'Affiliation': 'Imaging Diagnostic Center, Kumamoto Kinoh Hospital, Kumamoto, Japan.'}, {'ForeName': 'Tomoki', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Department of Orthopaedic Surgery, Kumamoto Kinoh Hospital, Kumamoto, Japan.'}]",Injury,['10.1016/j.injury.2020.06.001']
2165,32540210,Does accreditation affect the job satisfaction of general practitioners? A combined panel data survey and cluster randomised field experiment.,"A critical question for policy makers in health care is whether external interventions have unintended consequences such as lowering professionals' job satisfaction. We investigate whether a non-monetary incentive, in the form of mandatory accreditation, affects the job satisfaction of Danish GPs. Accreditation of general practice in Denmark was introduced as a cluster randomised stepwise implementation from 2016 to 2018. We measure job satisfaction at three time points: before the randomisation took place, one year into the accreditation process and two years into the accreditation process. We use a balanced panel of GPs who have completed all three waves of the survey (n = 846) and estimate a series of random and mixed effects ordered logit models. Despite many GPs having negative attitudes towards accreditation, we find no evidence of accreditation affecting GP job satisfaction. However, there are negative associations between job satisfaction and perceiving accreditation as a tool for external control. Policy makers are therefore encouraged to carefully inform about new interventions and identify barriers to diminish pre-existing negative perceptions about the incentive.",2020,"We investigate whether a non-monetary incentive, in the form of mandatory accreditation, affects the job satisfaction of Danish GPs.",[],[],['job satisfaction'],[],[],"[{'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}]",,0.0348546,"We investigate whether a non-monetary incentive, in the form of mandatory accreditation, affects the job satisfaction of Danish GPs.","[{'ForeName': 'Line Bjørnskov', 'Initials': 'LB', 'LastName': 'Pedersen', 'Affiliation': 'DaCHE - Danish Centre for Health Economics, Institute of Public Health, University of Southern Denmark, J.B. Winsløwsvej 9B, 5000 Odense C, Denmark; Research Unit for General Practice, Institute of Public Health, University of Southern Denmark, J.B. Winsløwsvej 9A, 5000 Odense C, Denmark. Electronic address: lib@sdu.dk.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Allen', 'Affiliation': 'Manchester Centre for Health Economics, University of Manchester, Oxford Road, Manchester M13 9PL, UK.'}, {'ForeName': 'Frans Boch', 'Initials': 'FB', 'LastName': 'Waldorff', 'Affiliation': 'Research Unit for General Practice, Institute of Public Health, University of Southern Denmark, J.B. Winsløwsvej 9A, 5000 Odense C, Denmark.'}, {'ForeName': 'Merethe Kirstine Kousgaard', 'Initials': 'MKK', 'LastName': 'Andersen', 'Affiliation': 'Research Unit for General Practice, Institute of Public Health, University of Southern Denmark, J.B. Winsløwsvej 9A, 5000 Odense C, Denmark.'}]","Health policy (Amsterdam, Netherlands)",['10.1016/j.healthpol.2020.04.002']
2166,32540235,Response Shift-Adjusted Treatment Effect on Health-Related Quality of Life in a Randomized Controlled Trial of Taxane Versus S-1 for Metastatic Breast Cancer: Structural Equation Modeling.,"OBJECTIVE


We investigated the quantification of the response shift-adjusted treatment effect on quality-of-life (QOL) data in a randomized controlled trial of taxane versus S-1 for patients with metastatic breast cancer (SELECT-BC).
METHODS


This study was a secondary data analysis of a previously published trial. The response shift-adjusted treatment effect on health-related QOL (HRQOL) data measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) was estimated using structural equation modeling techniques in addition to quantifying the ""true"" treatment effect. Measurement invariances in the values of the common factor loadings, intercepts, and residual variances between before treatment and at the 3-, 6-, and 12-month visits were considered the response shift effects.
RESULTS


In the taxane group, we observed positive recalibration effects for role functioning and positive reprioritization and negative recalibration effects for emotional functioning. The observed change of -4.56 for role functioning comprised +2.26 response shifts and -6.82 ""true"" change. The observed change of +9.41 for emotional functioning comprised +12.43 response shifts and -1.17 ""true"" change. In the S-1 group, we observed positive reprioritization and negative recalibration effects for emotional functioning and positive reprioritization effects for social functioning. The observed change of +10.54 for emotional functioning comprised +10.07 response shifts and +0.47 ""true"" change. The observed change of +2.43 for social functioning comprised +3.50 response shifts and -1.07 ""true"" change.
CONCLUSION


Detailed analysis of the response shift effects will improve the evaluation reliability of observed HRQOL data during clinical trials.",2020,"In the taxane group, we observed positive recalibration effects for role functioning and positive reprioritization and negative recalibration effects for emotional functioning.","['Metastatic Breast Cancer', 'patients with metastatic breast cancer (SELECT-BC']","['taxane', 'taxane versus S-1', 'Taxane']","['health-related QOL (HRQOL) data', 'Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30', 'Health-Related Quality of Life', 'quality-of-life (QOL']","[{'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core'}]",,0.318176,"In the taxane group, we observed positive recalibration effects for role functioning and positive reprioritization and negative recalibration effects for emotional functioning.","[{'ForeName': 'Tatsunori', 'Initials': 'T', 'LastName': 'Murata', 'Affiliation': 'Department of Oral Implantology, Osaka Dental University, Hirakata, Japan; CRECON Medical Assessment, Inc, Tokyo, Japan. Electronic address: tatsunori.murata@crecon.jp.'}, {'ForeName': 'Yoshimi', 'Initials': 'Y', 'LastName': 'Suzukamo', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Takeru', 'Initials': 'T', 'LastName': 'Shiroiwa', 'Affiliation': 'Department of Health and Welfare Services, National Institute of Public Health, Saitama, Japan.'}, {'ForeName': 'Naruto', 'Initials': 'N', 'LastName': 'Taira', 'Affiliation': 'Department of Breast and Endocrine Surgery, Okayama University Hospital, Okayama, Japan.'}, {'ForeName': 'Kojiro', 'Initials': 'K', 'LastName': 'Shimozuma', 'Affiliation': 'Department of Biomedical Sciences, Ritsumeikan University, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Ohashi', 'Affiliation': 'Department of Integrated Science and Engineering for Sustainable Society, Chuo University, Tokyo, Japan.'}, {'ForeName': 'Hirohumi', 'Initials': 'H', 'LastName': 'Mukai', 'Affiliation': 'Division of Breast and Medical Oncology, National Cancer Center Hospital East, Kashiwa, Chiba, Japan.'}]",Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research,['10.1016/j.jval.2020.02.003']
2167,32540277,High blood pressure responders show largest increase in heartbeat perception accuracy after post-learning stress following a cardiac interoceptive learning task.,"Mental disorders with physical symptoms, e.g. somatic symptom disorder, are characterized by altered interoceptive accuracy (IAc), which can be explained by individual differences in interoceptive learning (IL). We investigated if stress facilitates IL. Seventy-three healthy participants performed a heartbeat counting task (HCT: T1) and a heartbeat perception training (HBPT). After exposure to a socially-evaluated cold pressor stress test (SECPT; n = 48) or a control condition (n = 25), two more HCTs were performed (T2: 30 min after SECPT; T3: 24 h later). After the HBPT, all participants showed an increase in IAc. We separated the stress group into high vs. low systolic blood pressures (SBP) responders (n = 24 each), with high SBP responders showing the largest IAc increases. Only SBP, but not cortisol responsiveness significantly predicted IAc increase from T1 to T2. Our results indicate that post-learning autonomic stress response facilitates IL, whereas the HPA axis response may be less important for this effect.",2020,"Only SBP, but not cortisol responsiveness significantly predicted IAc increase from T1 to T2.","['Seventy-three healthy participants', 'Mental disorders with physical symptoms, e.g. somatic symptom disorder']","['heartbeat counting task (HCT: T1) and a heartbeat perception training (HBPT', 'SECPT']","['HPA axis response', 'IAc', 'systolic blood pressures (SBP) responders', 'heartbeat perception accuracy']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4087321', 'cui_str': 'Somatic symptom disorder'}]","[{'cui': 'C0425583', 'cui_str': 'Heart beat'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0085355', 'cui_str': 'Platelet-specific antigen'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0425583', 'cui_str': 'Heart beat'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",73.0,0.014762,"Only SBP, but not cortisol responsiveness significantly predicted IAc increase from T1 to T2.","[{'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Schenk', 'Affiliation': 'Clinical Psychophysiology Laboratory, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg.'}, {'ForeName': 'Jean T M', 'Initials': 'JTM', 'LastName': 'Fischbach', 'Affiliation': 'Clinical Psychophysiology Laboratory, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg.'}, {'ForeName': 'Ruta', 'Initials': 'R', 'LastName': 'Müller', 'Affiliation': 'Clinical Psychophysiology Laboratory, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Vögele', 'Affiliation': 'Clinical Psychophysiology Laboratory, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Witthöft', 'Affiliation': 'Division of Clinical Psychology, Department of Psychology, Johannes Gutenberg University of Mainz, Mainz, Germany.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Van Diest', 'Affiliation': 'Department of Health Psychology, Catholic University of Leuven, Leuven, Belgium.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Schulz', 'Affiliation': 'Clinical Psychophysiology Laboratory, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg. Electronic address: andre.schulz@uni.lu.'}]",Biological psychology,['10.1016/j.biopsycho.2020.107919']
2168,32540320,"Ski boot canting adjustments affect kinematic, kinetic, and postural control measures associated with fall and injury risk.","OBJECTIVES


The aim of this study was to investigate if and to what extent small lateral wedges inserted under the ski boot, known as canting, could impact knee kinematics/kinetics, balance, and neuromuscular activity in recreational alpine skiers in the laboratory setting.
DESIGN


Experimental, crossover study with repeated-measures analysis METHODS: Thirty-eight recreational skiers completed a single-leg postural balance test while wearing standardized ski boots in their unmodified state (control), and with medial and lateral canting wedges applied. Kinematics, kinetics, postural control measures, and neuromuscular activity of the lower extremity were assessed using optical motion capture, instrumented force plates, and electromyography.
RESULTS


Canting modifications had significant impact on lower extremity kinematics and kinetics: canting wedges on the medial side of the foot significantly decreased knee valgus moments, hip internal rotation, and hip adduction. Medial canting also improved some postural control measures associated with balance quality, and reduced activation levels of the Vastus Lateralis, Biceps Femoris, and Tibialis Anterior.
CONCLUSIONS


In the laboratory setting, canting appears to be an appropriate option for improving balance in alpine skiers. Medial canting can alter skier kinematics and kinetics in ways which are consistent with mechanisms of ACL injury. Canting may also result in reduced neuromuscular effort. These changes in movement have potential to prevent lower limb injuries in alpine skiers. The findings of this study motivate future research to predict individual responses to canting treatment in a study setting more closely resembling the sports environment.",2020,"Medial canting also improved some postural control measures associated with balance quality, and reduced activation levels of the Vastus Lateralis, Biceps Femoris, and Tibialis Anterior.
",['Thirty-eight recreational skiers completed a'],"['single-leg postural balance test while wearing standardized ski boots in their unmodified state (control), and with medial and lateral canting wedges applied']","['optical motion capture, instrumented force plates, and electromyography', 'lower extremity kinematics and kinetics', 'Kinematics, kinetics, postural control measures, and neuromuscular activity of the lower extremity', 'balance quality, and reduced activation levels of the Vastus Lateralis, Biceps Femoris, and Tibialis Anterior', 'knee valgus moments, hip internal rotation, and hip adduction']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0425040', 'cui_str': 'Skier'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C1256755', 'cui_str': 'Postural balance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0037262', 'cui_str': 'SKI'}, {'cui': 'C0331794', 'cui_str': 'Boots'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439639', 'cui_str': 'Wedge'}, {'cui': 'C1632850', 'cui_str': 'Apply'}]","[{'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0224449', 'cui_str': 'Biceps femoris muscle structure'}, {'cui': 'C0242690', 'cui_str': 'Tibialis anterior muscle structure'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0042282', 'cui_str': 'Valgus deformity'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0231457', 'cui_str': 'Adduction'}]",38.0,0.0218379,"Medial canting also improved some postural control measures associated with balance quality, and reduced activation levels of the Vastus Lateralis, Biceps Femoris, and Tibialis Anterior.
","[{'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Wilson', 'Affiliation': 'Steadman Philippon Research Institute, Department of Biomedical Engineering, USA. Electronic address: swilson@sprivail.org.'}, {'ForeName': 'Kimi D', 'Initials': 'KD', 'LastName': 'Dahl', 'Affiliation': 'Steadman Philippon Research Institute, Department of Biomedical Engineering, USA.'}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Dunford', 'Affiliation': 'Steadman Philippon Research Institute, Department of Biomedical Engineering, USA.'}, {'ForeName': 'Jacqueline N', 'Initials': 'JN', 'LastName': 'Foody', 'Affiliation': 'Steadman Philippon Research Institute, Department of Biomedical Engineering, USA.'}, {'ForeName': 'Payam', 'Initials': 'P', 'LastName': 'Zandiyeh', 'Affiliation': 'University of Texas Health Science Center, Department of Orthopedic Surgery, USA.'}, {'ForeName': 'Travis Lee', 'Initials': 'TL', 'LastName': 'Turnbull', 'Affiliation': 'Steadman Philippon Research Institute, Department of Biomedical Engineering, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Tashman', 'Affiliation': 'Steadman Philippon Research Institute, Department of Biomedical Engineering, USA.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.05.009']
2169,32540321,Perioperative Dexamethasone Is Associated With Higher Short-Term Mortality in Reconstructive Head and Neck Cancer Surgery.,"PURPOSE


Studies of the effects of perioperative dexamethasone (DEX) during oncologic surgery are scarce. The first aim of the present study was to clarify whether perioperative DEX affects the short-term mortality in patients with head and neck cancer (HNC). The second aim was to analyze the causes of death and predictors affecting long-term mortality.
PATIENTS AND METHODS


The present prospective, double-blind randomized, controlled study included patients with HNC who had undergone microvascular reconstruction from 2008 through 2013. The patients were randomized into 2 groups: the receipt of perioperative DEX for 3 days (study group) or no DEX (control group). The patients' data and cause of death were registered until the end of 2017. The primary cause of death was used in the analyses.
RESULTS


A total of 93 patients were included in the present study: 51 in the DEX group (study group) and 42 in the NON-DEX group (control group). Altogether 38 patients died during a median follow-up period of 5.3 years. During the first year, more deaths had occurred in the DEX group than in the NON-DEX group: at 1 month, 4% versus 0%; at 6 months, 14% versus 0%; and at 12 months, 22% versus 5% (P = .043). The overall survival rate for all patients was 59%. HNC was the primary cause of death for most of the patients who had died. On univariate analysis, the deceased patients had more advanced disease (higher T classification, P = .002; higher stage, P = .008), a greater need for a gastrostoma (P = .002), more often received postoperative chemotherapy (P = .005), and more often had locoregional (P = .025) or distal (P < .001) metastases. In the multivariate Cox model, the most important long-term predictors of death were the presence of distant metastases (P < .001), a Charlson comorbidity index (CCI) of 5 to 9 (P < .001), and the use of perioperative DEX (P = .004).
CONCLUSIONS


The use of perioperative DEX was associated with higher short-term mortality after reconstructive HNC surgery. The most important long-term predictors of death were the receipt of DEX, the presence of distant metastases, and a CCI of 5 to 9. These findings do not encourage the routine use of perioperative DEX for these patients.",2020,"On univariate analysis, the deceased patients had more advanced disease (higher T classification, P = .002; higher stage, P = .008), a greater need for a gastrostoma (P = .002), more often received postoperative chemotherapy (P = .005), and more often had locoregional (P = .025) or distal (P < .001) metastases.","['A total of 93 patients were included in the present study: 51 in the DEX group (study group) and 42 in the NON-DEX group (control group', 'patients with HNC who had undergone microvascular reconstruction from 2008 through 2013', 'Reconstructive Head and Neck Cancer Surgery', 'patients with head and neck cancer (HNC']","['perioperative DEX', 'DEX', 'no DEX', 'Perioperative Dexamethasone', 'perioperative dexamethasone (DEX']","['overall survival rate', 'death', 'deaths', 'Charlson comorbidity index (CCI', 'advanced disease']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C4546361', 'cui_str': 'Charlson Comorbidity Index'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",93.0,0.0680807,"On univariate analysis, the deceased patients had more advanced disease (higher T classification, P = .002; higher stage, P = .008), a greater need for a gastrostoma (P = .002), more often received postoperative chemotherapy (P = .005), and more often had locoregional (P = .025) or distal (P < .001) metastases.","[{'ForeName': 'Satu', 'Initials': 'S', 'LastName': 'Kainulainen', 'Affiliation': 'Consultant, Department of Oral and Maxillofacial Surgery, Helsinki University Hospital, University of Helsinki, Helsinki, Finland. Electronic address: satu.kainulainen@hus.fi.'}, {'ForeName': 'Katri', 'Initials': 'K', 'LastName': 'Aro', 'Affiliation': 'Consultant, Department of Otorhinolaryngology-Head and Neck Surgery, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Koivusalo', 'Affiliation': 'Consultant and Docent, Department of Anesthesia and Intensive Care Unit, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Wilkman', 'Affiliation': 'Consultant, Department of Oral and Maxillofacial Surgery, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Risto P', 'Initials': 'RP', 'LastName': 'Roine', 'Affiliation': 'Professor Emeritus, Department of Health and Social Management, University of Eastern Finland, Kuopio; and Professor Emeritus, Group Administration, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Pasi', 'Initials': 'P', 'LastName': 'Aronen', 'Affiliation': 'Biostatistics Consultant, Department of Public Health, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Jyrki', 'Initials': 'J', 'LastName': 'Törnwall', 'Affiliation': 'Consultant and Docent, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Lassus', 'Affiliation': 'Department Head and Docent, Department of Plastic Surgery, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.05.004']
2170,32540325,Risk factors for visual field deterioration in the United Kingdom Glaucoma Treatment Study.,"OBJECTIVE


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


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


Five hundred sixteen participants with previously untreated OAG were prospectively recruited in 10 UK centres.
METHODS


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


Time-to-VF deterioration.
RESULTS


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


In the UKGTS, treatment with latanoprost halved VF deterioration risk. Bilateral disease, higher IOP and disc haemorrhage were confirmed as risk factors for deterioration; smoking history appeared to be protective against VF deterioration.",2020,"Bilateral disease, higher IOP and disc haemorrhage were confirmed as risk factors for deterioration; smoking history appeared to be protective against VF deterioration.","['Eligibility criteria were modeled on those for the Early Manifest Glaucoma Trial', 'open-angle glaucoma (OAG', 'Five hundred sixteen participants with previously untreated OAG were prospectively recruited in 10 UK centres']","['latanoprost', 'placebo']","['bilateral disease', 'higher baseline IOP', 'disc haemorrhage', 'Time-to-VF deterioration', 'Bilateral disease, higher IOP and disc haemorrhage', 'VF deterioration risk', 'VF testing and intraocular pressure (IOP) measurement', 'reduced HR for VF deterioration', 'HR for VF deterioration']","[{'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0090306', 'cui_str': 'latanoprost'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0234708', 'cui_str': 'Raised intraocular pressure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0042825', 'cui_str': 'Visual field study'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",516.0,0.300799,"Bilateral disease, higher IOP and disc haemorrhage were confirmed as risk factors for deterioration; smoking history appeared to be protective against VF deterioration.","[{'ForeName': 'Panayiota', 'Initials': 'P', 'LastName': 'Founti', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK. Electronic address: pfounti@gmail.com.'}, {'ForeName': 'Catey', 'Initials': 'C', 'LastName': 'Bunce', 'Affiliation': ""National Institute for Health Research Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK; King's College London, London School of Hygiene & Tropical Medicine, London, UK.""}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Khawaja', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK.'}, {'ForeName': 'Caroline J', 'Initials': 'CJ', 'LastName': 'Doré', 'Affiliation': 'Comprehensive Clinical Trials Unit at University College London, London, UK.'}, {'ForeName': 'Jibran', 'Initials': 'J', 'LastName': 'Mohamed-Noriega', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Garway-Heath', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2020.06.009']
2171,32540337,Consolidation cetuximab after concurrent triplet radiochemotherapy + cetuximab in patients with advanced head and neck cancer: A randomized phase II study.,"BACKGROUND AND PURPOSE


Preclinical data suggest that cetuximab should be continued after end of concurrent radiotherapy + cetuximab due to its efficacy against residual tumor cells in the irradiated tumor bed. Based on this concept the phase II add-on cetuximab (AOC) study was designed.
MATERIALS AND METHODS


Altogether 63 patients with advanced head and neck cancer were treated with radiochemotherapy (70 Gy, cisplatin 40mg/m2 weekly) in combination with concurrent cetuximab (loading dose 400mg/m2, then 250mg/m2 weekly). Thereafter patients were randomized to cetuximab consolidation (500 mg/m2 biweekly x 6) or no further treatment. The primary endpoint was the 2-year locoregional control (LRC) rate. As translational research endpoints serum markers were analyzed before and during treatment and CT-based quantitative image analysis (radiomics) was performed.
RESULTS


Median follow-up was 24 months. The 2-year LRC rates were 67.9% and 67.7% in the treatment arms with and without consolidation cetuximab, respectively. Higher than median levels of three serum markers were negatively associated with the 2-year LRC rate in the overall patient cohort: Osteopontin, IL8 and FasL2 (p≤0.05). A radiomics model consisting of two radiomics features could be built showing that higher entropy and higher complexity of tumor Hounsfield unit distribution indicates worse LRC (concordance index 0.66). No correlation was found between biological and imaging markers.
CONCLUSIONS


There was no evidence that consolidation cetuximab would improve the 2-year LRC rate. Prognostic biological and imaging markers could be identified for the overall patient cohort. Studies with larger patient numbers are needed to correlate biological and imaging markers.",2020,"Higher than median levels of three serum markers were negatively associated with the 2-year LRC rate in the overall patient cohort: Osteopontin, IL8 and FasL2 (p≤0.05).","['Altogether 63 patients with advanced head and neck cancer', 'patients with advanced head and neck cancer']","['radiochemotherapy + cetuximab', 'radiochemotherapy (70 Gy, cisplatin 40mg/m2 weekly) in combination with concurrent cetuximab', 'Consolidation cetuximab', 'radiotherapy + cetuximab', 'cetuximab consolidation']","['2-year LRC rates', '2-year LRC rate', '2-year locoregional control (LRC) rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}]","[{'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",63.0,0.0261113,"Higher than median levels of three serum markers were negatively associated with the 2-year LRC rate in the overall patient cohort: Osteopontin, IL8 and FasL2 (p≤0.05).","[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Riesterer', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Cantonal Hospital Lucerne, Switzerland; Center for Radiation Oncology KSA-KSB, Kantonsspital Aarau, Cantonal Hospital Lucerne, Switzerland. Electronic address: oliver.riesterer@ksa.ch.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Pruschy', 'Affiliation': 'Laboratory for Molecular Radiobiology, University of Zurich, Cantonal Hospital Lucerne, Switzerland.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Bender', 'Affiliation': 'Laboratory for Molecular Radiobiology, University of Zurich, Cantonal Hospital Lucerne, Switzerland.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Laboratory for Molecular Radiobiology, University of Zurich, Cantonal Hospital Lucerne, Switzerland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Bogowicz', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Cantonal Hospital Lucerne, Switzerland.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Tanadini-Lang', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Cantonal Hospital Lucerne, Switzerland.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Stieb', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Cantonal Hospital Lucerne, Switzerland.'}, {'ForeName': 'Kaja', 'Initials': 'K', 'LastName': 'Bertogg', 'Affiliation': 'Clinical Trials Center, University Hospital Zurich, University of Zurich, Cantonal Hospital Lucerne, Switzerland.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Weber', 'Affiliation': 'Clinical Trials Center, University Hospital Zurich, University of Zurich, Cantonal Hospital Lucerne, Switzerland.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Ikenberg', 'Affiliation': 'Institute of Pathology and Molecular Pathology University Hospital Zurich, University of Zurich, Cantonal Hospital Lucerne, Switzerland.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Huber', 'Affiliation': 'Department of Otorhinolaryngology, University Hospital Zurich, University of Zurich, Cantonal Hospital Lucerne, Switzerland; Department of Otorhinolaryngology, Cantonal Hospital St. Gallen, Cantonal Hospital Lucerne, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Schmid', 'Affiliation': 'Otorhinolaryngology Clinic Bethanien, Zurich, Cantonal Hospital Lucerne, Switzerland.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Bredell', 'Affiliation': 'Clinic for Oral and Maxillofacial Surgery, University Hospital Zurich, University of Zurich, Cantonal Hospital Lucerne, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Veit-Haibach', 'Affiliation': 'Department of Nuclear Medicine, University Hospital Zurich, Cantonal Hospital Lucerne, Switzerland; Department of Diagnostic and Interventional Radiology, University Hospital Zurich, University of Zurich, Cantonal Hospital Lucerne, Switzerland.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Rordorf', 'Affiliation': 'Department of Medical Oncology, University Hospital Zurich, University of Zurich, Cantonal Hospital Lucerne, Switzerland.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Held', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, Department of Biostatistics, University of Zurich, Cantonal Hospital Lucerne, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Glanzmann', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Cantonal Hospital Lucerne, Switzerland; Department of Radiation Oncology, Cantonal Hospital Lucerne, Switzerland.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Studer', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Cantonal Hospital Lucerne, Switzerland; Department of Radiation Oncology, Cantonal Hospital Lucerne, Switzerland.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.06.011']
2172,32540410,Health-related quality of life in individuals with metabolic syndrome: A cross-sectional study.,"INTRODUCTION AND OBJECTIVES


Metabolic syndrome (MetS) is a combination of various cardiovascular risk factors with a major impact on morbidity and premature mortality. However, the impact of MetS on self-reported health-related quality of life (HRQoL) is unknown. This study evaluated the HRQoL in a Spanish adult population aged 55 years and older with MetS.
METHOD


A cross-sectional analysis was performed with baseline data from the PREDIMED-Plus multicentre randomized trial. The participants were 6430 men and women aged 55-75 years with overweight/obesity (body mass index ≥27 and ≤40kg/m 2 ) and MetS. The SF-36 questionnaire was used as a tool to measure HRQoL. Scores were calculated on each scale of the SF-36 by gender and age.
RESULTS


Participants showed higher scores in the social function (mean 85.9, 95% CI; 85.4-86.4) and emotional role scales (mean 86.8, 95% CI; 86.0-87.5). By contrast, the worst scores were obtained in the aggregated physical dimensions. In addition, men obtained higher scores than women on all scales. Among men, the worst score was obtained in general health (mean 65.6, 95% CI; 65.0-66.2), and among women, in body pain (mean 54.3, 95%CI; 53.4-55.2). A significant decrease was found in the aggregated physical dimensions score among participants 70-75 years old, but an increased one in the aggregated mental dimensions, compared to younger participants.
CONCLUSIONS


Our results reflect that the MetS may negatively affect HRQoL in the aggregated physical dimensions, body pain in women, and general health in men. However, this adverse association was absent for the psychological dimensions of HRQoL, which were less affected.",2020,"RESULTS


Participants showed higher scores in the social function (mean 85.9, 95% CI; 85.4-86.4) and emotional role scales (mean 86.8, 95% CI; 86.0-87.5).","['Spanish adult population aged 55 years and older with MetS', 'participants were 6430 men and women aged 55-75 years with overweight/obesity (body mass index ≥27 and ≤40kg/m 2 ) and MetS', 'individuals with metabolic syndrome']",['HRQoL'],"['morbidity and premature mortality', 'social function', 'aggregated physical dimensions score', 'emotional role scales', 'Health-related quality of life']","[{'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1855073', 'cui_str': 'Premature Mortality'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0205418', 'cui_str': 'Aggregate'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",6430.0,0.0835636,"RESULTS


Participants showed higher scores in the social function (mean 85.9, 95% CI; 85.4-86.4) and emotional role scales (mean 86.8, 95% CI; 86.0-87.5).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Marcos-Delgado', 'Affiliation': 'The Research Group in Gene - Environment and Health Interactions, IBIOMED - University of León, León, Spain; Department of Biomedical Sciences, Area of Preventive Medicine and Public Health, University of León, León, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'López-García', 'Affiliation': 'Bioaraba Health Research Institute; Osakidetza Basque Health Service, Araba University Hospital; University of the Basque Country UPV/EHU; Vitoria-Gasteiz, Spain; Nutritional Genomics and Epigenomics Group, IMDEA Food Institute, CEI UAM+CSIC, Madrid, Spain; Department of Preventive Medicine and Public Health, Universidad Autónoma de Madrid/ IdiPaz, Madrid, Spain.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Martínez-González', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain; University of Navarra, Department of Preventive Medicine and Public Health, IdiSNA, Pamplona, Spain; Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Salas-Salvadó', 'Affiliation': ""Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain; Universitat Rovira i Virgili, Departament de Bioquímica i Biotecnologia, Unitat de Nutrició, Reus, Spain; University Hospital of Sant Joan de Reus, Nutrition Unit, Reus, Spain; Institut d'Investigació Sanitària Pere Virgili (IISPV), Reus, Spain.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Corella', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain; Department of Preventive Medicine, University of Valencia, Valencia, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fitó', 'Affiliation': ""Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain; Unit of Cardiovascular Risk and Nutrition, Institut Hospital del Mar de Investigaciones Médicas Municipal d'Investigació Médica (IMIM), Barcelona, Spain.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Romaguera', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain; Health Research Institute of the Balearic Islands (IdISBa), Palma de Mallorca, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Vioque', 'Affiliation': 'CIBER de Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, Madrid, Spain; Miguel Hernandez University, ISABIAL-FISABIO, Alicante, Spain.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Alonso-Gómez', 'Affiliation': 'Bioaraba Health Research Institute; Osakidetza Basque Health Service, Araba University Hospital; University of the Basque Country UPV/EHU; Vitoria-Gasteiz, Spain; Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wärnberg', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain; Department of Nursing, School of Health Sciences, University of Málaga-Institute of Biomedical Research in Malaga (IBIMA), Málaga, Spain.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Martínez', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain; Department of Nutrition, Food Sciences, and Physiology, Center for Nutrition Research, University of Navarra, Pamplona, Spain; Cardiometabolic Nutrition Group, IMDEA Food, CEI UAM + CSIC, Madrid, Spain.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Serra-Majem', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain; Nutrition Research Group, Research Institute of Biomedical and Health Sciences (IUIBS), University of Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Estruch', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain; Department of Internal Medicine, IDIBAPS, Hospital Clinic, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Fernández-García', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain; Virgen de la Victoria Hospital, Department of Endocrinology, Instituto de Investigación Biomédica de Málaga (IBIMA). University of Málaga, Málaga, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lapetra', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain; Department of Family Medicine, Research Unit, Distrito Sanitario Atención Primaria Sevilla, Sevilla, Spain.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Pintó', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain; Lipids and Vascular Risk Unit, Internal Medicine, Hospital Universitario de Bellvitge-IDIBELL, Hospitalet de Llobregat, Barcelona, Spain; University of Barcelona, Spain.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Tur', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain; Health Research Institute of the Balearic Islands (IdISBa), Palma de Mallorca, Spain; Research Group on Community Nutrition & Oxidative Stress, University of Balearic Islands, Palma de Mallorca, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'López-Miranda', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain; Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Cordoba, Spain.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Cano-Ibañez', 'Affiliation': 'CIBER de Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, Madrid, Spain; Department of Preventive Medicine and Public Health, University of Granada, Granada, Spain; Instituto de Investigación Biosanitaria de Granada (ibs.GRANADA), Granada, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Delgado-Rodríguez', 'Affiliation': 'Department of Nursing, School of Health Sciences, University of Málaga-Institute of Biomedical Research in Malaga (IBIMA), Málaga, Spain; Division of Preventive Medicine, Faculty of Medicine, University of Jaén, Jaén, Spain.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Matía-Martín', 'Affiliation': 'Department of Endocrinology and Nutrition, Instituto de Investigación Sanitaria Hospital Clínico San Carlos (IdISSC), Madrid, Spain.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Daimiel', 'Affiliation': 'Nutritional Genomics and Epigenomics Group, IMDEA Food Institute, CEI UAM+CSIC, Madrid, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Carriedo', 'Affiliation': 'Centro de Salud de José Aguado. Gerencia de Atención Primaria de León.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Vidal', 'Affiliation': ""Department of Endocrinology, Institut d'Investigacions Biomédiques August Pi Sunyer (IDIBAPS), Hospital Clinic, University of Barcelona, Barcelona, Spain; CIBER Diabetes y Enfermedades Metabólicas (CIBERDEM), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Vázquez', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain; Department of Endocrinology, Fundación Jiménez-Díaz, Madrid, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ros', 'Affiliation': ""Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain; Lipid Clinic, Department of Endocrinology and Nutrition, Institut d'Investigacions Biomèdiques August Pi Sunyer (IDIBAPS), Hospital Clínic, Barcelona, Spain.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lozano-Oloriz', 'Affiliation': 'University of Navarra, Department of Preventive Medicine and Public Health, IdiSNA, Pamplona, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bulló', 'Affiliation': ""Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain; Universitat Rovira i Virgili, Departament de Bioquímica i Biotecnologia, Unitat de Nutrició, Reus, Spain; Institut d'Investigació Sanitària Pere Virgili (IISPV), Reus, Spain.""}, {'ForeName': 'J V', 'Initials': 'JV', 'LastName': 'Sorlí', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain; Department of Preventive Medicine, University of Valencia, Valencia, Spain.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Zomeño', 'Affiliation': ""Unit of Cardiovascular Risk and Nutrition, Institut Hospital del Mar de Investigaciones Médicas Municipal d'Investigació Médica (IMIM), Barcelona, Spain; Blanquerna, School of Health Sciences, Universitat Ramon Llull, Barcelona.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fiol', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain; Health Research Institute of the Balearic Islands (IdISBa), Palma de Mallorca, Spain.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'González-Palacios', 'Affiliation': 'CIBER de Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, Madrid, Spain; Miguel Hernandez University, ISABIAL-FISABIO, Alicante, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sorto-Sánchez', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain; Bioaraba Health Research Institute; Osakidetza Basque Health Service, Araba University Hospital; University of the Basque Country UPV/EHU; Vitoria-Gasteiz, Spain.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Pérez-Farinós', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain; Departament of Public Health, University of Málaga-Institute of Biomedical Research in Málaga (IBIMA), Málaga, Spain.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Goñi-Ruiz', 'Affiliation': 'University of Navarra, Department of Preventive Medicine and Public Health, IdiSNA, Pamplona, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sanchez-Villegas', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain; Nutrition Research Group, Research Institute of Biomedical and Health Sciences (IUIBS), University of Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Muñoz-Garach', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain; Virgen de la Victoria Hospital, Department of Endocrinology, Instituto de Investigación Biomédica de Málaga (IBIMA). University of Málaga, Málaga, Spain; Hospital Virgen de las Nieves de Granada, Departament of Endocrinology and Nutrition.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Santos-Lozano', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain; Lipids and Vascular Risk Unit, Internal Medicine, Hospital Universitario de Bellvitge-IDIBELL, Hospitalet de Llobregat, Barcelona, Spain; Departament of Medicine, University of Sevilla, Sevilla, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Galera', 'Affiliation': 'Lipids and Vascular Risk Unit, Internal Medicine, Hospital Universitario de Bellvitge-IDIBELL, Hospitalet de Llobregat, Barcelona, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bouzas', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain; Health Research Institute of the Balearic Islands (IdISBa), Palma de Mallorca, Spain; Research Group on Community Nutrition & Oxidative Stress, University of Balearic Islands, Palma de Mallorca, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Toledo', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain; University of Navarra, Department of Preventive Medicine and Public Health, IdiSNA, Pamplona, Spain.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Babio', 'Affiliation': ""Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain; Universitat Rovira i Virgili, Departament de Bioquímica i Biotecnologia, Unitat de Nutrició, Reus, Spain; Institut d'Investigació Sanitària Pere Virgili (IISPV), Reus, Spain.""}, {'ForeName': 'J I', 'Initials': 'JI', 'LastName': 'González', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain; Department of Preventive Medicine, University of Valencia, Valencia, Spain.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Del Val-García', 'Affiliation': 'Institut Català de la Salut and IDIAP Jordi Gol, Barcelona, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Moñino', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain; Health Research Institute of the Balearic Islands (IdISBa), Palma de Mallorca, Spain.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Martínez-Vergaran', 'Affiliation': 'CIBER de Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, Madrid, Spain; Miguel Hernandez University, ISABIAL-FISABIO, Alicante, Spain.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Goicolea-Güemez', 'Affiliation': 'Bioaraba Health Research Institute; Osakidetza Basque Health Service, Araba University Hospital; University of the Basque Country UPV/EHU; Vitoria-Gasteiz, Spain; Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Galilea-Zabalza', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Basora', 'Affiliation': ""Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain; Universitat Rovira i Virgili, Departament de Bioquímica i Biotecnologia, Unitat de Nutrició, Reus, Spain; Lipid Clinic, Department of Endocrinology and Nutrition, Institut d'Investigacions Biomèdiques August Pi Sunyer (IDIBAPS), Hospital Clínic, Barcelona, Spain; Institut Català de la Salut and IDIAP Jordi Gol, Barcelona, Spain.""}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Muñoz', 'Affiliation': 'Unitat de Suport a la Recerca de Barcelona. IDIAPJGol. Gerencia de Atención Primaria de Barcelona. Institut Català de la Salut, Barcelona.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Builf', 'Affiliation': 'University of Navarra, Department of Preventive Medicine and Public Health, IdiSNA, Pamplona, Spain.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Fernández-Villa', 'Affiliation': 'The Research Group in Gene - Environment and Health Interactions, IBIOMED - University of León, León, Spain; Department of Biomedical Sciences, Area of Preventive Medicine and Public Health, University of León, León, Spain. Electronic address: tferv@unileon.es.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Semergen,['10.1016/j.semerg.2020.03.003']
2173,32540553,Metronomic oral chemotherapy with cyclophosphamide plus capecitabine combined with trastuzumab (HEX) as first line therapy of HER-2 positive advanced breast cancer: A phase II trial of the Gruppo Oncologico Italia Meridionale (GOIM).,"BACKGROUND


The combination of chemotherapy plus anti HER-2 agents is the mainstay of HER-2 positive advanced breast cancer (ABC) therapy. We conducted a phase II trial testing activity and safety of trastuzumab and metronomic capecitabine/cyclophosphamide (HEX) as first-line therapy in HER-2 positive ABC.
Methods. Patients at first relapse or with synchronous metastasis were treated with trastuzumab (4 mg/kg, biweekly) plus oral capecitabine (1500 mg/daily) and cyclophosphamide (50 mg/daily). Primary endpoint was objective response rate (ORR), secondary endpoints progression-free survival (PFS), clinical benefit rate (CBR; PR + CR + SD for ≥ 24 weeks) and tolerability. Optimal two-stage design was applied.
RESULTS


Sixty patients with measurable ABC, tumors scored as +3 for HER-2 or FISH +, untreated for advanced disease were enrolled. Median age was 62.5 years, visceral metastases were present in most patients (57.9%). Median number of cycles was 16 (range 1-98). ORR was 56.7% (95% CI, 44.1-68.4%), with 5 CR (8.3%) and 29 PR (48.3%). Fifteen patients had SD (25%). The CBR was 78.2%. Nine progressions were observed (15%). Median PFS was 11 months. One year PFS was 47.7%. Median OS was 45.9 months. Worst toxicities were grade 3 hand-foot syndrome in 2 pts (3.3%), grade 3 anaemia in 2 pts (3.3%), grade 2 nausea in 2 pts (3.3%) and grade 3-4 diarrhea in 2 pts (3.3%). Cardiac toxicity grade 1 was reported in 1 pt.
CONCLUSIONS


Combination of trastuzumab and metronomic oral chemotherapy has clinical activity. The tolerability was excellent and allowed the prolonged delivery of treatment.",2020,"ORR was 56.7% (95% CI, 44.1-68.4%), with 5 CR (8.3%) and 29 PR (48.3%).","['Patients at first relapse or with synchronous metastasis', 'HER-2 positive advanced breast cancer', 'HER-2 positive advanced breast cancer (ABC) therapy', 'Sixty patients with measurable ABC, tumors scored as\xa0+3 for HER-2 or FISH\xa0+, untreated for advanced disease were enrolled', 'Fifteen patients had SD (25']","['trastuzumab', 'cyclophosphamide', 'chemotherapy plus anti HER-2 agents', 'trastuzumab and metronomic capecitabine/cyclophosphamide (HEX', 'trastuzumab and metronomic oral chemotherapy', 'oral capecitabine', 'Metronomic oral chemotherapy with cyclophosphamide plus capecitabine combined with trastuzumab (HEX']","['Median PFS', 'grade 2 nausea', 'Median OS', 'Worst toxicities', 'grade 3 anaemia', 'ORR', 'objective response rate (ORR), secondary endpoints progression-free survival (PFS), clinical benefit rate (CBR; PR\xa0+\xa0CR\xa0+\xa0SD for\xa0≥\xa024 weeks) and tolerability', 'Cardiac toxicity grade 1', 'tolerability', 'Median number of cycles', 'visceral metastases', 'grade 3-4 diarrhea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0419073', 'cui_str': 'Oral chemotherapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",9.0,0.0480206,"ORR was 56.7% (95% CI, 44.1-68.4%), with 5 CR (8.3%) and 29 PR (48.3%).","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Orlando', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy. Electronic address: laura.orlando68@gmail.com.'}, {'ForeName': 'Vito', 'Initials': 'V', 'LastName': 'Lorusso', 'Affiliation': 'Medical Oncology, Istituto Tumori Giovanni Paolo II, IRCCS, Bari, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Giotta', 'Affiliation': 'Medical Oncology, Istituto Tumori Giovanni Paolo II, IRCCS, Bari, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Di Maio', 'Affiliation': 'Department of Oncology, University of Turin at Ordine Mauriziano Hospital, Turin, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Schiavone', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Palma', 'Initials': 'P', 'LastName': 'Fedele', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Quaranta', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Caliolo', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Ciccarese', 'Affiliation': 'Medical Oncology, Ospedale Vito Fazzi, Lecce, Italy.'}, {'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Cinefra', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Sante', 'Initials': 'S', 'LastName': 'Romito', 'Affiliation': 'Medical Oncology, Ospedali Riuniti, Foggia, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Pisconti', 'Affiliation': 'Medical Oncology, Ospedale Moscato, Taranto, Italy.'}, {'ForeName': 'Salvatore Del', 'Initials': 'SD', 'LastName': 'Prete', 'Affiliation': 'Medical Oncology, Ospedale San Giovanni di Dio, Frattamaggiore, Napoli, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Aieta', 'Affiliation': 'Medical Oncology, Ospedale Oncologico Regionale, Rionero in Vulture, Potenza, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Rizzi', 'Affiliation': 'Medical Oncology, Istituto Tumori Giovanni Paolo II, IRCCS, Bari, Italy.'}, {'ForeName': 'Evaristo', 'Initials': 'E', 'LastName': 'Maiello', 'Affiliation': 'Medical Oncology, Ospedale Sollievo Della Sofferenza, IRCCS, San Giovanni Rotondo, Foggia, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Colucci', 'Affiliation': 'Medical Oncology, Istituto Tumori Giovanni Paolo II, IRCCS, Bari, Italy.'}, {'ForeName': 'Saverio', 'Initials': 'S', 'LastName': 'Cinieri', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.06.002']
2174,32540584,The effect of injection volume on long-term outcomes of US-guided subacromial bursa injections.,"PURPOSE


Limited data exist on the efficacy of high- compared to low-volume US-guided corticosteroid injections (CI) in the subacromial-subdeltoid (SA-SD) bursa. Our purpose was to compare the short- and long-term efficacy of low- and high-volume injections, by using a capacity reference of SA-SD bursa volume, as assessed on cadaveric specimens.
METHOD


Within two years, 136 patients (63 males, 73 females; mean age: 46.11 ± 10.28 years) who underwent SA-SD bursa US-guided CI for subacromial impingement, rotator cuff tendinopathy or shoulder overuse were prospectively included. Patients were randomly assigned to low-volume (1 mL triamcinolone acetonide/40 mg) or high-volume (1 mL triamcinolone acetonide/40 mg, 9 mL anaesthetic agents) groups (67 and 69 patients, respectively). Visual Analogue Scores (VAS) were recorded at baseline, 30 min, 3 weeks, 3 months, 6 months and 1 year post-treatment. Predictors of complete recovery (VAS ≤ 2) at 1 year were analysed with multivariate Cox regression analysis. SA-SD bursa cadaveric dissection in 10 specimens was performed for volume assessment.
RESULTS


Injection volume was the only predictor of complete pain resolution at 1 year. High-volume CI yielded higher chances of early pain recovery (2.837 HR, 95% CI 1.737-4.633, P < .001). Mean VAS scores at baseline and subsequent time-points were 6, 2.6, 2.2, 2, 1.6 and 1 for the high-volume and 7.8, 7.3, 4.7, 3.2, 2.5 and 1.8 for the low-volume group, respectively (P < .001, at all time-points). Cadaveric measurements showed a minimum SA-SD bursa volume of approximately 6.9 mL.
CONCLUSIONS


High-compared to low-volume US-guided CI are superior for achieving early pain recovery.",2020,"High-volume CI yielded higher chances of early pain recovery (2.837 HR, 95% CI 1.737-4.633, P < .001).","['136 patients (63 males, 73 females; mean age: 46.11\u202f±\u202f10.28 years) who underwent SA-SD bursa US-guided CI for subacromial impingement, rotator cuff tendinopathy or shoulder overuse were prospectively included']","['US-guided subacromial bursa injections', 'low-volume US-guided corticosteroid injections (CI', 'low- and high-volume injections', 'triamcinolone acetonide/40\u202fmg) or high-volume (1\u202fmL triamcinolone acetonide/40\u202fmg, 9\u202fmL anaesthetic agents']","['minimum SA-SD bursa volume', 'complete pain resolution', 'chances of early pain recovery', 'Visual Analogue Scores (VAS', 'Mean VAS scores']","[{'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006441', 'cui_str': 'Structure of bursa'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0376685', 'cui_str': 'Impingement syndrome of shoulder region'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0224792', 'cui_str': 'Structure of subacromial bursa'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0002932', 'cui_str': 'Anesthetic'}]","[{'cui': 'C0006441', 'cui_str': 'Structure of bursa'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.107082,"High-volume CI yielded higher chances of early pain recovery (2.837 HR, 95% CI 1.737-4.633, P < .001).","[{'ForeName': 'Michail E', 'Initials': 'ME', 'LastName': 'Klontzas', 'Affiliation': 'Department of Medical Imaging, University Hospital, Voutes, 71110, Heraklion, Crete, Greece; Advanced Hybrid Imaging Systems, Institute of Computer Science, Foundation for Research and Technology (FORTH), 100 N. Plastira str., Voutes, 70013, Heraklion, Crete, Greece.'}, {'ForeName': 'Evangelia E', 'Initials': 'EE', 'LastName': 'Vassalou', 'Affiliation': 'Department of Medical Imaging, University Hospital, Voutes, 71110, Heraklion, Crete, Greece; Department of Radiology, General Hospital of Sitia, Xserokamares, 72300, Sitia, Lasithi, Crete, Greece. Electronic address: vassalou.e@hotmail.com.'}, {'ForeName': 'Aristeidis H', 'Initials': 'AH', 'LastName': 'Zibis', 'Affiliation': 'University of Thessaly, Faculty of Medicine, Department of Anatomy Mezourlo Viopolis, 41222, Larissa, Greece.'}, {'ForeName': 'Apostolos H', 'Initials': 'AH', 'LastName': 'Karantanas', 'Affiliation': 'Department of Medical Imaging, University Hospital, Voutes, 71110, Heraklion, Crete, Greece; Department of Radiology, Medical School, University of Crete, Voutes, 71110, Heraklion, Greece.'}]",European journal of radiology,['10.1016/j.ejrad.2020.109113']
2175,32540588,Deep transcranial magnetic stimulation for obsessive-compulsive disorder is efficacious even in patients who failed multiple medications and CBT.,"OCD is a chronic and disabling disease with a lifetime prevalence of 2%-3%. About 40-60% of these patients do not adequately respond to pharmacotherapy and CBT. Deep transcranial magnetic stimulation (dTMS) was shown to be safe and effective as a treatment alternative for OCD and recently received regulatory approvals. Yet it is unclear whether patients who failed numerous medications and/or CBT can still benefit from dTMS. Here, we analyzed recent data from a double-blind multicenter dTMS study and found efficacy of this novel treatment even in OCD patient cohorts who previously failed to respond to multiple medications and CBT.",2020,Deep transcranial magnetic stimulation (dTMS) was shown to be safe and effective as a treatment alternative for OCD and recently received regulatory approvals.,"['OCD patient cohorts who previously failed to respond to multiple medications and CBT', 'patients who failed multiple medications and CBT']","['OCD', 'Deep transcranial magnetic stimulation', 'Deep transcranial magnetic stimulation (dTMS']",[],"[{'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]",[],,0.0274375,Deep transcranial magnetic stimulation (dTMS) was shown to be safe and effective as a treatment alternative for OCD and recently received regulatory approvals.,"[{'ForeName': 'Yiftach', 'Initials': 'Y', 'LastName': 'Roth', 'Affiliation': 'The Department of Life Sciences and the Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Noam', 'Initials': 'N', 'LastName': 'Barnea-Ygael', 'Affiliation': 'The Department of Life Sciences and the Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Carmi', 'Affiliation': 'Chaim Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Storch', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Baylor College of Medicine, TX, USA.'}, {'ForeName': 'Aron', 'Initials': 'A', 'LastName': 'Tendler', 'Affiliation': 'Advanced Mental Health Care, Inc., Palm Beach, FL, USA.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Zangen', 'Affiliation': 'The Department of Life Sciences and the Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel. Electronic address: azangen@bgu.ac.il.'}]",Psychiatry research,['10.1016/j.psychres.2020.113179']
2176,32540624,Effects of night-time bicycling visibility aids on vehicle passing distance.,"Bicycling at night is dangerous, with vehicle passing distances being a key concern, given that the main cause of night-time bicycling fatalities is from motorists hitting bicyclists from behind. However, little is known about vehicle passing distances at night or how they are affected by bicyclist visibility. This study assessed the impact of different bicyclist visibility configurations on vehicle passing distances at night-time. Fourteen licenced drivers with normal vision (age 24.2 ± 3.7 years) drove an experimental vehicle with low-beam headlights around a 1-km section of a closed-road circuit at night. Each lap involved passing two bicyclists displaying one of four visibility configurations: Control (red rear-facing light and reflector), Handlebars (control plus two red rear-facing lights on each handlebar), Helmet (control plus one red rear-facing light on the helmet), and Leg Retro-reflectors (control plus retro-reflective strips positioned on the knees and ankles). Participants were instructed to pass each bicyclist at a distance of 1-metre at a speed no greater than 50 km/hr, consistent with Queensland's Minimum Passing Distance rule. Participants completed eight laps, two for each configuration, in a randomised sequence. Passing distance was measured using a vehicle-mounted ultra-sonic sensor (ToughSonic14; Senix). Following each lap, participants rated the difficulty level in judging the 1-metre passing distance, as well as their estimated passing distance. Visibility configuration significantly affected passing distance (p = 0.001), with wider passing distances for the Handlebar configuration (1.54 ± 0.62 m), followed by the Helmet (1.51 ± 0.63 m), Leg Retro-reflectors (1.50 ± 0.62 m) which were all significantly greater than the Control (1.42 ± 0.57 m), but not significantly different from each other. There was also a significant effect of visibility configuration on difficulty rating (p = 0.035), with the Control rated as the most difficult, followed by Helmet, Handlebars and Leg Retro-reflectors. Overall, additional visibility aids resulted in wider vehicle passing distances, likely due to enhanced visual cues for drivers. The findings suggest that bicyclists should incorporate additional visibility aids to encourage safer passing distances of vehicles at night-time.",2020,"Visibility configuration significantly affected passing distance (p = 0.001), with wider passing distances for the Handlebar configuration (1.54 ± 0.62 m), followed by the Helmet (1.51 ± 0.63 m), Leg Retro-reflectors (1.50 ± 0.62 m) which were all significantly greater than the Control (1.42 ± 0.57 m), but not significantly different from each other.",['Fourteen licenced drivers with normal vision (age 24.2\u202f±\u202f3.7 years) drove an experimental vehicle with low-beam headlights around a 1-km section of a closed-road circuit at night'],"['visibility configurations: Control (red rear-facing light and reflector), Handlebars (control plus two red rear-facing lights on each handlebar), Helmet (control plus one red rear-facing light on the helmet), and Leg Retro-reflectors (control plus retro-reflective strips positioned on the knees and ankles', 'night-time bicycling visibility aids']","['visibility configuration on difficulty rating', 'Leg Retro-reflectors']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0234622', 'cui_str': 'Normal vision'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C0240526', 'cui_str': 'Night time'}]","[{'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0018884', 'cui_str': 'Helmet'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0005375', 'cui_str': 'Bicycle'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]","[{'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}]",,0.0635457,"Visibility configuration significantly affected passing distance (p = 0.001), with wider passing distances for the Handlebar configuration (1.54 ± 0.62 m), followed by the Helmet (1.51 ± 0.63 m), Leg Retro-reflectors (1.50 ± 0.62 m) which were all significantly greater than the Control (1.42 ± 0.57 m), but not significantly different from each other.","[{'ForeName': 'Alex A', 'Initials': 'AA', 'LastName': 'Black', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia. Electronic address: aa.black@qut.edu.au.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Duff', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Hutchinson', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Ng', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Kirby', 'Initials': 'K', 'LastName': 'Phillips', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Katelyn', 'Initials': 'K', 'LastName': 'Rose', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Ussher', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'Wood', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}]",Accident; analysis and prevention,['10.1016/j.aap.2020.105636']
2177,32540634,"A randomized, double blind, placebo controlled study to evaluate the effects of ashwagandha (Withania somnifera) extract on sleep quality in healthy adults.","OBJECTIVE


Non-restorative sleep (NRS) affects 10% people worldwide, leading to poor sleep quality, as well as physical and cognitive fatigue. This is the first human study in which an extract of ashwagandha (Withania somnifera Dunal L.) was evaluated for effects in improving overall sleep quality in subjects with NRS.
METHODS


In this randomized, double-blind, placebo-controlled trial, 150 healthy subjects scoring high on non-restorative sleep measures were given 120 mg of standardized ashwagandha extract (Shoden®) once daily for six weeks. Subjects were evaluated using the Restorative Sleep Questionnaire-weekly version and World Health Organization Quality of Life-Bref (WHOQOL) scale. Sleep actigraphy was used to measure the onset of sleep latency, sleep efficiency, total sleep time and wake after sleep onset. Safety of the treatment was determined by testing of vitals, hematology, biochemistry and urinalysis.
RESULTS


A total of 144 subjects completed the study, with no dropouts due to adverse events. A 72% increase in self-reported sleep quality was found for the treatment group, compared with 29% in the placebo group (p < 0.001). Based on activity monitoring data, the treatment group showed significant improvement in sleep efficiency (SE) (p < 0.01), total sleep time (p < 0.001) and sleep latency (p < 0.01) and wake after sleep onset (WASO) (p < 0.05) versus placebo after six weeks. In the ashwagandha group quality of life (QOL) scores showed significant improvement in physical (p < 0.001), psychological (p < 0.001), and environment domains (p < 0.01).
CONCLUSIONS


Supplementation with the standardized ashwagandha extract for six weeks improved the overall quality of sleep by significantly improving the NRS condition in healthy subjects. No treatment related adverse events were reported in the study.
TRIAL REGISTRATION


Clinical Trials Registry-India (www.ctri.nic.in). Registration number: CTRI/2017/02/007801.",2020,"Based on activity monitoring data, the treatment group showed significant improvement in sleep efficiency (SE) (p < 0.01), total sleep time (p < 0.001) and sleep latency (p < 0.01) and wake after sleep onset (WASO) (p < 0.05) versus placebo after six weeks.","['subjects with NRS', 'healthy subjects', 'healthy adults', '150 healthy subjects scoring high on non-restorative sleep measures', '144 subjects completed the study, with no dropouts due to adverse events']","['standardized ashwagandha extract (Shoden®', 'ashwagandha (Withania somnifera) extract', 'placebo']","['Sleep actigraphy', 'Restorative Sleep Questionnaire-weekly version and World Health Organization Quality of Life-Bref (WHOQOL) scale', 'total sleep time', 'overall quality of sleep', 'onset of sleep latency, sleep efficiency, total sleep time and wake after sleep onset', 'overall sleep quality', 'sleep latency', 'adverse events', 'quality of life (QOL) scores', 'sleep quality', 'self-reported sleep quality', 'sleep efficiency (SE']","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]","[{'cui': 'C0613707', 'cui_str': 'Ashwagandha'}, {'cui': 'C1061163', 'cui_str': 'Withania somnifera'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",150.0,0.234196,"Based on activity monitoring data, the treatment group showed significant improvement in sleep efficiency (SE) (p < 0.01), total sleep time (p < 0.001) and sleep latency (p < 0.01) and wake after sleep onset (WASO) (p < 0.05) versus placebo after six weeks.","[{'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Deshpande', 'Affiliation': 'International Institute of Sleep Sciences (IISS), NEST Hospital, Second Floor, Behind SBI Naupada Br, Off Gokhale Road, Naupada, Thane, Maharashtra, 400602, India. Electronic address: abhijitd1965@gmail.com.'}, {'ForeName': 'Nushafreen', 'Initials': 'N', 'LastName': 'Irani', 'Affiliation': 'International Institute of Sleep Sciences (IISS), NEST Hospital, Second Floor, Behind SBI Naupada Br, Off Gokhale Road, Naupada, Thane, Maharashtra, 400602, India.'}, {'ForeName': 'Ratna', 'Initials': 'R', 'LastName': 'Balkrishnan', 'Affiliation': 'International Institute of Sleep Sciences (IISS), NEST Hospital, Second Floor, Behind SBI Naupada Br, Off Gokhale Road, Naupada, Thane, Maharashtra, 400602, India.'}, {'ForeName': 'Irin Rosanna', 'Initials': 'IR', 'LastName': 'Benny', 'Affiliation': 'Amala Institute of Medical Sciences, Amala Nagar PO, Thrissur, Kerala, 680555, India.'}]",Sleep medicine,['10.1016/j.sleep.2020.03.012']
2178,32540685,"Impact of the group intervention ""Accept Voices©"" for the management of auditory hallucinations.","AIM OF THE STUDY


The objective of this study was to evaluate the potential impact of a third wave CBT group intervention for the management of auditory hallucinations in patients with schizophrenia.
METHOD


38 patients with schizophrenia presenting with auditory hallucinations, followed in mental health services, participated in six sessions of a group based on acceptance and engagement therapy (ACT). The study followed a repeated single case experimental design (type A-B-A) based on the principle of a control phase followed by an intervention phase and a follow-up phase of similar duration. The various measurements were administered during the control phase, at pre-/post-group and six weeks after the last group session.
RESULTS


The results show a significant decrease in auditory hallucinations, as measured by the PSYRATS scale, during the treatment and follow-up phase, compared to the control phase. In addition, the participants saw significant reductions in depressive and anxious symptomatology (assessed with CDSS and SEAS), and increases in coping and acceptance in regards to voices (assessed using a study scale and VAAS). The level of Malevolence beliefs about voices (measured with BAVQ-R) also decreased significantly.
CONCLUSIONS


A brief group intervention based acceptance show promise in the reduction of the intensity of auditory hallucinations, depression and anxiety in patients with schizophrenia, while improving their acceptance.",2020,"A brief group intervention based acceptance show promise in the reduction of the intensity of auditory hallucinations, depression and anxiety in patients with schizophrenia, while improving their acceptance.","['patients with schizophrenia', '38 patients with schizophrenia presenting with auditory hallucinations, followed in mental health services, participated in six sessions of a group based on']","['acceptance and engagement therapy (ACT', 'CBT group intervention']","['depressive and anxious symptomatology', 'auditory hallucinations', 'level of Malevolence beliefs about voices (measured with BAVQ-R', 'coping and acceptance', 'intensity of auditory hallucinations, depression and anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0233762', 'cui_str': 'Auditory hallucinations'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0233762', 'cui_str': 'Auditory hallucinations'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",38.0,0.0263279,"A brief group intervention based acceptance show promise in the reduction of the intensity of auditory hallucinations, depression and anxiety in patients with schizophrenia, while improving their acceptance.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Langlois', 'Affiliation': ""Centre d'Études et de Recherches en Psychopathologie et Psychopathologie de la Santé, Université de Toulouse, UT2J, France. Electronic address: thomas.langlois@univ-tlse2.fr.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Sanchez-Rodriguez', 'Affiliation': ""Centre d'Études et de Recherches en Psychopathologie et Psychopathologie de la Santé, Université de Toulouse, UT2J, France.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bourcier', 'Affiliation': 'CHU Toulouse Purpan, Toulouse, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lamy', 'Affiliation': 'Centre médical la Villanelle, Cornebarrieu, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Callahan', 'Affiliation': ""Centre d'Études et de Recherches en Psychopathologie et Psychopathologie de la Santé, Université de Toulouse, UT2J, France.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Lecomte', 'Affiliation': 'Université de Montréal, Montréal, Canada.'}]",Psychiatry research,['10.1016/j.psychres.2020.113159']
2179,32540720,Beta-band oscillations as a biomarker of gait recovery in spinal cord injury patients: A quantitative electroencephalography analysis.,"OBJECTIVE


The gait recovery in spinal cord injury (SCI) seems to be partially related to the reorganization of cerebral function; however, the neural mechanisms and the respective biomarkers are not well known. This study tested the hypothesis that enhanced beta-band oscillations may be a marker of compensatory neural plasticity during the recovery period in SCI. We tested this hypothesis at baseline in SCI subjects and also in response to cortical stimulation with transcranial direct current stimulation (tDCS) combined with robotic-assisted gait training (RAGT).
METHODS


In this neurophysiological analysis of a randomized controlled trial, thirty-nine patients with incomplete SCI were included. They received 30 sessions of either active or sham anodal tDCS over the primary motor area for 20 min combined with RAGT. We analyzed the Electroencephalography (EEG) power spectrum and task-related power modulation of EEG oscillations, and their association with gait function indexed by Walk Index for Spinal Cord Injury (WISCI-II). Univariate and multivariate linear/logistic regression analyses were performed to identify the predictors of gait function and recovery.
RESULTS


Consistent with our hypothesis, we found that in the sensorimotor area: (1) Anodal tDCS combined with RAGT can modulate high-beta EEG oscillations power and enhance gait recovery; (2) higher high-beta EEG oscillations power at baseline can predict baseline gait function; (3) high-beta EEG oscillations power at baseline can predict gait recovery - the higher power at baseline, the better gait recovery; (4) decreases in relative high-beta power and increases in beta power decrease during walking are associated with gait recovery.
CONCLUSIONS


Enhanced EEG beta oscillations in the sensorimotor area in SCI subjects may be part of a compensatory mechanism to enhance local plasticity. Our results point to the direction that interventions enhancing local plasticity such as tDCS combined with robotic training also lead to an immediate increase in sensorimotor cortex activation, improvement in gait recovery, and subsequent decrease in high-beta power. These findings suggest that beta-band oscillations may be potential biomarkers of gait function and recovery in SCI.
SIGNIFICANCE


These findings are significant for rehabilitation in SCI patients, and as EEG is a portable, inexpensive, and easy-to-apply system, the clinical translation is feasible to follow better the recovery process and to help to individualize rehabilitation therapies of SCI patients.",2020,This study tested the hypothesis that enhanced beta-band oscillations may be a marker of compensatory neural plasticity during the recovery period in SCI.,"['thirty-nine patients with incomplete SCI were included', 'spinal cord injury patients', 'SCI subjects', 'spinal cord injury (SCI', 'SCI patients']","['active or sham anodal tDCS over the primary motor area for 20\xa0min combined with RAGT', 'transcranial direct current stimulation (tDCS) combined with robotic-assisted gait training (RAGT']","['high-beta EEG oscillations power and enhance gait recovery', 'Electroencephalography (EEG) power spectrum and task-related power modulation of EEG oscillations, and their association with gait function indexed by Walk Index for Spinal Cord Injury (WISCI-II', 'gait recovery', 'sensorimotor cortex activation']","[{'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C3499125', 'cui_str': 'Sensory Motor Cortex'}]",39.0,0.0972225,This study tested the hypothesis that enhanced beta-band oscillations may be a marker of compensatory neural plasticity during the recovery period in SCI.,"[{'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Simis', 'Affiliation': 'Physical and Rehabilitation Medicine Institute, General Hospital, Medical School of the University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Elif', 'Initials': 'E', 'LastName': 'Uygur-Kucukseymen', 'Affiliation': 'Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Pacheco-Barrios', 'Affiliation': 'Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA; Universidad San Ignacio de Loyola, Vicerrectorado de Investigación, Unidad de Investigación para la Generación y Síntesis de Evidencias en Salud. Lima, Peru.'}, {'ForeName': 'Linamara R', 'Initials': 'LR', 'LastName': 'Battistella', 'Affiliation': 'Physical and Rehabilitation Medicine Institute, General Hospital, Medical School of the University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Fregni', 'Affiliation': 'Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA. Electronic address: Fregni.Felipe@mgh.harvard.edu.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2020.04.166']
2180,32540725,Significant immunomodulatory properties of curcumin in patients with osteoarthritis; a successful clinical trial in Iran.,"Osteoarthritis (OA) routinely is known as a multifactorial degenerative joint disease. This trial aimed to assess the curcumin (an active element of turmeric) effects on the immune responses in OA patients. Thirty patients were selected according to the American College of Rheumatology (ACR) criteria and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and equally divided into the two groups; intervention (received Sinacurcumin® 80 mg daily) and placebo, followed for 3 months. In the intervention group, our data showed a noticeably decrease in Visual Analog Score (VAS), C-reactive protein (CRP), CD4 +  and CD8 +  T cells, Th17 cells and B cells frequency. Additionally, Treg cells indicated a significant increase and Treg/Th17 cells ratio showed a meaningfully shifted toward Treg lymphocytes. In conclusion, our data indicated that clinical manifestation was ameliorated considerably following the administration of curcumin. Moreover, our data demonstrated the immunomodulatory effects of curcumin in OA patients.",2020,"In the intervention group, our data showed a noticeably decrease in Visual Analog Score (VAS), C-reactive protein (CRP), CD4 +  and CD8 +  T cells, Th17 cells and B cells frequency.","['Thirty patients were selected according to the American College of Rheumatology (ACR) criteria and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and equally divided into the two groups', 'patients with osteoarthritis', 'OA patients']","['intervention (received Sinacurcumin® 80\xa0mg daily) and placebo', 'curcumin']","['Visual Analog Score (VAS), C-reactive protein (CRP), CD4 +  and CD8 +  T cells, Th17 cells and B cells frequency']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C2936411', 'cui_str': 'T Helper 17 Cells'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",30.0,0.0327408,"In the intervention group, our data showed a noticeably decrease in Visual Analog Score (VAS), C-reactive protein (CRP), CD4 +  and CD8 +  T cells, Th17 cells and B cells frequency.","[{'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Atabaki', 'Affiliation': 'Allergy Research Center, Mashhad University of Medical Sciences, Mashhad, Iran; Department of Immunology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Zhaleh', 'Initials': 'Z', 'LastName': 'Shariati-Sarabi', 'Affiliation': 'Rheumatic Diseases Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Jalil', 'Initials': 'J', 'LastName': 'Tavakkol-Afshari', 'Affiliation': 'Immunology Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Mohammadi', 'Affiliation': 'Immunology Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: mohammadimzh@mums.ac.ir.'}]",International immunopharmacology,['10.1016/j.intimp.2020.106607']
2181,32540779,Comparison of simple frenotomy with 4-flap Z-frenuloplasty in treatment for ankyloglossia with articulation difficulty: A prospective randomized study.,"OBJECTIVE


To compare the surgical outcomes of simple frenotomy and the 4-flap Z-frenuloplasty according to the articulation test values and tongue-tie classification in patients with ankyloglossia with articulation difficulty.
STUDY DESIGN


prospective randomized study.
SETTING


Tertiary academic center.
SUBJECTS


and methods: Children with ankyloglossia with articulation difficulty were randomly divided into 2 groups for surgical treatment. Patients were evaluated for the tongue-tie classification and articulation test before surgery. Three months after the operation, the frenulum classification and articulation test were re-evaluated to compare the differences in surgical outcome between the two surgical methods.
RESULTS


Out of 37 patients, 19 underwent the 4-flap Z-frenuloplasty and 18, the simple frenotomy. No differences were observed in the baseline characteristics of the patients assigned to both groups. Changes in the tongue-tie classification and improvement in the articulation test results were observed with both the surgical methods. Both surgical groups had significant improvement in the speech articulation test (consonants) but there was no difference in the speech outcomes between the surgical groups.
CONCLUSION


Although there was no significant difference in the surgical outcome between the two surgical methods, ankyloglossia patients showed improvement in a Korean speech articulation test 3 months after undergoing surgery to release the lingual frenulum.",2020,"Both surgical groups had significant improvement in the speech articulation test (consonants) but there was no difference in the speech outcomes between the surgical groups.
","['patients with ankyloglossia with articulation difficulty', 'ankyloglossia with articulation difficulty', 'and methods', 'Children with ankyloglossia with articulation difficulty', 'Tertiary academic center', '37 patients, 19 underwent the 4-flap Z-frenuloplasty and 18, the simple frenotomy']","['simple frenotomy and the 4-flap Z-frenuloplasty', 'simple frenotomy with 4-flap Z-frenuloplasty']","['speech articulation test', 'speech outcomes', 'surgical outcome', 'Korean speech articulation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152415', 'cui_str': 'Tongue tie'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0192139', 'cui_str': 'Incision of lingual frenum'}]","[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0192139', 'cui_str': 'Incision of lingual frenum'}, {'cui': 'C0038925', 'cui_str': 'Flap'}]","[{'cui': 'C0037819', 'cui_str': 'Speech Articulation Tests'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}]",37.0,0.0322658,"Both surgical groups had significant improvement in the speech articulation test (consonants) but there was no difference in the speech outcomes between the surgical groups.
","[{'ForeName': 'Tae Hoon', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'Department of Otorhinolaryngology - Head & Neck Surgery, School of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Young Chan', 'Initials': 'YC', 'LastName': 'Lee', 'Affiliation': 'Department of Otorhinolaryngology - Head & Neck Surgery, School of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Seung Don', 'Initials': 'SD', 'LastName': 'Yoo', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Seung Ah', 'Initials': 'SA', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Young-Gyu', 'Initials': 'YG', 'LastName': 'Eun', 'Affiliation': 'Department of Otorhinolaryngology - Head & Neck Surgery, School of Medicine, Kyung Hee University, Seoul, Republic of Korea. Electronic address: ygeun@khu.ac.kr.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110146']
2182,32540793,Outcomes of Optical Coherence Tomography Compared With Intravascular Ultrasound and With Angiography to Guide Coronary Stent Implantation: One-Year Results from the ILUMIEN III: OPTIMIZE PCI trial.,"AIMS


In the ILUMIEN III trial, among 450 randomised patients with non-complex lesions undergoing percutaneous coronary intervention (PCI), optical coherence tomography (OCT) guidance led to greater stent expansion than angiography guidance, similar minimal stent area compared to both intravascular ultrasound (IVUS) guidance and angiography guidance, and lower rates of uncorrected dissection and malapposition than both IVUS guidance and angiography guidance. Whether these differences impact clinical outcomes is unknown.
METHODS AND RESULTS


OCT-guided PCI, using an external elastic lamina-based protocol, was compared to operator-directed IVUS-guided or angiography-guided PCI. Target lesion failure (TLF) and major adverse cardiovascular events (MACE) at 12 months were adjudicated by a blinded clinical events committee. There were no significant differences in the rates of TLF (2.0% OCT, 3.7% IVUS, 1.4% angiography), MACE (9.8% OCT, 9.1% IVUS, 7.9% angiography), or any of the individual components of these outcomes between groups. No independent predictors of 12-month stent-related clinical events were identified from final OCT.
CONCLUSIONS


In this underpowered study, OCT-guided PCI of non-complex lesions did not show a statistical difference in clinical outcomes at 12-months compared with IVUS or angiography guidance. An appropriately powered trial, including only complex patients and lesions, is underway to substantiate the potential clinical benefit for OCT-guided PCI.",2020,"There were no significant differences in the rates of TLF (2.0% OCT, 3.7% IVUS, 1.4% angiography), MACE",['450 randomised patients with non-complex lesions undergoing'],"['MACE', 'Guide Coronary Stent Implantation', 'Optical Coherence Tomography Compared With Intravascular Ultrasound and With Angiography', 'percutaneous coronary intervention (PCI), optical coherence tomography (OCT) guidance']","['rates of TLF', 'Target lesion failure (TLF) and major adverse cardiovascular events (MACE']","[{'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0687568', 'cui_str': 'Coronary artery stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",450.0,0.0706358,"There were no significant differences in the rates of TLF (2.0% OCT, 3.7% IVUS, 1.4% angiography), MACE","[{'ForeName': 'Ziad A', 'Initials': 'ZA', 'LastName': 'Ali', 'Affiliation': 'Centre for Interventional Vascular Therapy, Division of Cardiology, New York-Presbyterian Hospital/Columbia University Medical Centre, New York, NY USA.'}, {'ForeName': 'Keyvan', 'Initials': 'K', 'LastName': 'Karimi Galougahi', 'Affiliation': ''}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Maehara', 'Affiliation': ''}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Shlofmitz', 'Affiliation': ''}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Fabbiocchi', 'Affiliation': ''}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Guagliumi', 'Affiliation': ''}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Alfonso', 'Affiliation': ''}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Akasaka', 'Affiliation': ''}, {'ForeName': 'Mitsuaki', 'Initials': 'M', 'LastName': 'Matsumura', 'Affiliation': ''}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Mintz', 'Affiliation': ''}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Ben-Yehuda', 'Affiliation': ''}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Richard R', 'Initials': 'RR', 'LastName': 'Rapoza', 'Affiliation': ''}, {'ForeName': 'Nick E J', 'Initials': 'NEJ', 'LastName': 'West', 'Affiliation': ''}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-20-00498']
2183,32540806,"Comparing effects of low glycemic index/high-fat, high-calorie diet and high-fat, high-calorie diet on cytokine levels of patients with cystic fibrosis: A randomized controlled clinical trial.","The importance of the host inflammatory response, as a central pathological feature of cystic fibrosis, is well recognized. Additionally, hyperglycemia can induce an immune response and consecutively may exacerbate symptoms of this disease. Hence, adherence to a low glycemic index diet, through normalizing blood glucose levels, may reduce inflammation in patients with this disease. This study aimed to compare effects of a low glycemic index/high-fat, high-calorie diet and routine high-fat, high-calorie diet on inflammatory biomarkers in patients with cystic fibrosis. In this randomized clinical trial, 44 children and adolescents with cystic fibrosis were randomly assigned to receive for three months either a high-fat, high-calorie diet (n = 22) or a low glycemic index/high-fat, high-calorie diet (n = 22) with similar calorie and macronutrients composition to the control diet. Patients in first arm were allowed to use all sources of carbohydrates with different glycemic indices, whereas those in another arm consumed carbohydrates from low glycemic index sources. Serum levels of the pro-inflammatory cytokines IL-6, IL-17A, and IFNγ, and the anti-inflammatory cytokine IL-10 were measured at baseline and after the end of the trial. There were significant differences between groups for IL-6 (P = 0.02) and IL-17 (P = 0.01), in favor of the low glycemic diet, but no between-group differences were detected in IL-10 and IFN-γ. Although serum levels of IL-17 were reduced in both the groups as compared with the baseline values, this reduction was only significant in the group assigned to the low glycemic diet (P= 0.007), In addition, IL-6 serum levels decreased and those of IL-10 increased significantly as compared with the baseline values in the low glycemic diet (P= 0.01). It seems that adherence to a low glycemic index/high-fat, high-calorie diet for three months can improve some inflammatory biomarkers in children and adolescents with cystic fibrosis compared with the high-fat, high-calorie diet.",2020,There were significant differences between groups for IL-6,"['children and adolescents with cystic fibrosis', '44 children and adolescents with cystic fibrosis', 'patients with this disease', 'patients with cystic fibrosis']","['low glycemic index/high-fat, high-calorie diet and high-fat, high-calorie diet', 'high-fat, high-calorie diet (n\u2009=\u200922) or a low glycemic index/high-fat, high-calorie diet (n\u2009=\u200922) with similar calorie and macronutrients composition to the control diet', 'low glycemic index/high-fat, high-calorie diet and routine high-fat, high-calorie diet']","['IL-10 and IFN-γ', 'cytokine levels', 'serum levels of IL-17', 'IL-6 serum levels', 'Serum levels of the pro-inflammatory cytokines IL-6, IL-17A, and IFNγ, and the anti-inflammatory cytokine IL-10', 'IL-6', 'IL-10', 'IL-17']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0301590', 'cui_str': 'Increased calorie diet'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C1701790', 'cui_str': 'IL17A protein, human'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}]",44.0,0.0387221,There were significant differences between groups for IL-6,"[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Gorji', 'Affiliation': 'Department of Cellular and Molecular Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Modaresi', 'Affiliation': ""Pediatric Pulmonary Disease and Sleep Medicine Research Center, Pediatric Center of Excellence, Children's Medical Center, Tehran, Iran.""}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Yekanni-Nejad', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Rezaei', 'Affiliation': ""Department of Immunology, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran, Research Center for Immunodeficiencies, Pediatrics Center of Excellence, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran, Network of Immunity in Infection, Malignancy and Autoimmunity (NIIMA), Universal Scientific Education and Research Network (USERN), Tehran, Iran.""}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Mahmoudi', 'Affiliation': 'Department of Cellular and Molecular Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran, Dietetics and Nutrition Experts Team (DiNET), Universal Scientific Education and Research Network (USERN), Tehran, Iran.'}]",European cytokine network,['10.1684/ecn.2020.0442']
2184,32540838,A description of Covid-19 modifications to the TEAMS study protocol for remotely delivering teleassessment/teletraining of complementary alternative medicine among people with multiple sclerosis: protocol for a randomized controlled effectiveness trial.,"BACKGROUND


Access to comprehensive exercise/rehabilitation services for people with multiple sclerosis (MS) remains a major challenge, especially in rural, low-income areas. Hence, the Tele-Exercise and Multiple Sclerosis (TEAMS) study aims to provide patient-centered, coordinated care by implementing a 12-week complementary and alternative medicine (CAM) intervention for adults with MS. However, due to the societal impact of Covid-19 in mid-March 2020, the University of Alabama at Birmingham announced a limited business model halting all non-essential research requiring on-site visits, including the TEAMS study.
OBJECTIVE


In compliance with the shelter-in-place policy and quarantine guidance during Covid-19, a modified testing and training protocol was developed to allow participants to continue the study.
METHODS


The modified protocol, which replaces the on-site data collection and training procedures, includes a teleassessment package (laptop computer, blood pressure cuff, hand dynamometer, mini- disc cone, measuring tape, an 8"" step, and a large print 8""x11"" paper with ruler metrics and wall-safe tape) and virtual meeting platform for synchronous interactive training between therapist and participant. The teleassessment measures include resting blood pressure and heart rate, the Hand-Grip Strength Test; Five Times Sit to Stand test; Timed Up & Go test; and Berg Balance Scale. The teletraining component includes 20 sessions of synchronous training sessions of dual tasking, yoga, and Pilates exercises designed and customized for a range of functional levels. Teletraining lasts 12 weeks and participants are instructed to continue exercising for one-year post-training.
RESULTS


The protocol modifications were supported with supplemental funding (Patient-Centered Outcomes Research Institute [PCORI]) and approved by the University Institutional Review Board for Human Use. At the time non-essential research visits were halted by the University, there were 759 people enrolled and baseline tested in the study (92.5% of our baseline testing completion target: 820). Specifically, 325 participants completed the 12-week intervention and follow-up testing visits, and 289 participants needed to complete either the intervention or follow-up assessments. A modified analysis plan will include sensitivity analyses to ensure the robustness of the study results in presence of uncertainty and protocol deviations. Study results are projected to be published in 2021.
CONCLUSIONS


This modified remote teleassessment/teletraining protocol will impact a large number of participants with MS who would otherwise have discontinued the study.
CLINICALTRIAL


ClinicalTrials.gov NCT03117881.",2020,A modified analysis plan will include sensitivity analyses to ensure the robustness of the study results in presence of uncertainty and protocol deviations.,"['325 participants completed the 12-week intervention and follow-up testing visits, and 289 participants needed to complete either the intervention or follow-up assessments', 'participants with MS who would otherwise have discontinued the study', '759 people enrolled and baseline tested in the study (92.5% of our baseline testing completion target: 820', 'people with multiple sclerosis (MS', 'people with multiple sclerosis', 'adults with MS']","['synchronous training sessions of dual tasking, yoga, and Pilates exercises designed and customized', 'comprehensive exercise/rehabilitation services', 'alternative medicine (CAM) intervention', 'teleassessment package (laptop computer, blood pressure cuff, hand dynamometer, mini- disc cone, measuring tape, an 8"" step, and a large print 8""x11"" paper with ruler metrics and wall-safe tape) and virtual meeting platform for synchronous interactive training between therapist and participant']","['resting blood pressure and heart rate, the Hand-Grip Strength Test; Five Times Sit to Stand test; Timed Up & Go test; and Berg Balance Scale']","[{'cui': 'C4517714', 'cui_str': '325'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0587660', 'cui_str': 'Rehabilitation service'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C1737642', 'cui_str': 'Laptop computer'}, {'cui': 'C0180208', 'cui_str': 'Blood pressure cuff'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C3881002', 'cui_str': 'Mini disc'}, {'cui': 'C0206428', 'cui_str': 'Cone of retina'}, {'cui': 'C0336570', 'cui_str': 'Measuring tape'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0522637', 'cui_str': 'Measuring ruler'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}]",759.0,0.0382581,A modified analysis plan will include sensitivity analyses to ensure the robustness of the study results in presence of uncertainty and protocol deviations.,"[{'ForeName': 'Byron', 'Initials': 'B', 'LastName': 'Lai', 'Affiliation': 'Division of Pediatric Rehabilitation Medicine, School of Medicine, University of Alabama at Birmingham, 1720 University Blvd, Birmingham, US.'}, {'ForeName': 'Chia-Ying', 'Initials': 'CY', 'LastName': 'Chiu', 'Affiliation': 'Department of Health Services Administration, School of Health Professions, University of Alabama at Birmingham, Birmingham, US.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Pounds', 'Affiliation': ""Dean's Office, School of Health Professions, University of Alabama at Birmingham, Birmingham, US.""}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Tracy', 'Affiliation': 'Tanner Foundation, Birmingham, US.'}, {'ForeName': 'Tapan', 'Initials': 'T', 'LastName': 'Mehta', 'Affiliation': 'Department of Health Services Administration, School of Health Professions, University of Alabama at Birmingham, Birmingham, US.'}, {'ForeName': 'Hui-Ju', 'Initials': 'HJ', 'LastName': 'Young', 'Affiliation': 'Department of Physical Therapy, School of Health Professions, University of Alabama at Birmingham, Birmingham, US.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Riser', 'Affiliation': 'Tanner Foundation, Birmingham, US.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Rimmer', 'Affiliation': ""Dean's Office, School of Health Professions, University of Alabama at Birmingham, Birmingham, US.""}]",JMIR research protocols,['10.2196/18415']
2185,32540842,One Drop with an Activity Tracker for Adults with Type 1 Diabetes: Randomized Control Trial.,"BACKGROUND


In 2017, 9% of the population of adults with diabetes could receive digital care. By 2045, digital care will increase by 48%. One Drop's (OD) digital care solution includes an evidence-based mobile app, a Bluetooth-connected glucometer, and in-app coaching from Certified Diabetes Educators. Using OD is associated with a 3-mo. -22.2 mg/dL (-.80% eA1c) among people with type 1 diabetes (T1D) and eA1c ≥ 7.5%. The added value of integrated activity trackers is unknown.
OBJECTIVE


We conducted a pragmatic, remotely administered, randomized control trial to evaluate One Drop with a new-to-market activity tracker on the A1c of adults with T1D.
METHODS


Social media advertisements and online newsletters recruited adults (≥ 18 years old) diagnosed (≥ 1 year) with T1D, naïve to OD's full solution and the activity tracker with lab A1c ≥ 7%. Participants (N = 99) were randomized to get OD plus activity tracker at study start or OD at start and an activity tracker after 3 mos. Multiple imputation, performed separately by group, corrected for missing data. ANCOVA models, controlling for baseline A1c, tested 3-mo. A1c differences in intent-to-treat (ITT) and per protocol (PP) analyses.
RESULTS


The enrolled sample (n = 95) was 41 ± 11 years old, 73% female, 88% White, diagnosed for 20 ± 11 years with a mean A1c of 8.4% ± 1.2%. 11% did not complete follow-up. ANCOVA assumptions were met ITT and PP models. In ITT, participants with OD + tracker had a significantly lower three-month A1c (7.9% [95% CI 7.8 - 8.2]  .60%) than did participants with OD only (8.4% [95% CI 8.2 - 8.5]  .62%). In PP, participants with OD + activity tracker also had a statistically significant lower three-month A1c (7.9% [95% CI 7.7 - 8.1]  .59%) than did participants with OD only (8.2% [95% CI 8.0 - 8.4]  .58%).
CONCLUSIONS


Participants exposed to OD + tracker for the three-month trial period had a significantly lower three-month A1c compared to participants exposed to OD only during the same timeframe. OD and tracker may work better together than alone in helping people with T1D.
CLINICALTRIAL


Registration: NCT03459573, https://clinicaltrials.gov/ct2/show/NCT03459573.",2020,"In ITT, participants with OD + tracker had a significantly lower three-month A1c (7.9% [95% CI 7.8 - 8.2]  .60%) than did participants with OD only (8.4% [95% CI 8.2 - 8.5]  .62%).","['Participants (N = 99', ""adults with T1D.\nMETHODS\n\n\nSocial media advertisements and online newsletters recruited adults (≥ 18 years old) diagnosed (≥ 1 year) with T1D, naïve to OD's full solution and the activity tracker with lab A1c ≥ 7"", 'The enrolled sample (n = 95) was 41 ± 11 years old, 73% female, 88% White, diagnosed for 20 ± 11 years with a mean A1c of 8.4% ± 1.2', 'Adults with Type 1 Diabetes']","['OD plus activity tracker', 'new-to-market activity tracker', 'Activity Tracker']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0027988', 'cui_str': 'Newsletters'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1318228', 'cui_str': 'Market'}]",[],99.0,0.0789327,"In ITT, participants with OD + tracker had a significantly lower three-month A1c (7.9% [95% CI 7.8 - 8.2]  .60%) than did participants with OD only (8.4% [95% CI 8.2 - 8.5]  .62%).","[{'ForeName': 'Chandra Y', 'Initials': 'CY', 'LastName': 'Osborn', 'Affiliation': 'Informed Data Systems Inc., 85 Delancey St, Ste 71, New York, US.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Hirsch', 'Affiliation': 'Informed Data Systems Inc., 85 Delancey St, Ste 71, New York, US.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Sears', 'Affiliation': 'Informed Data Systems Inc., 85 Delancey St, Ste 71, New York, US.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Heyman', 'Affiliation': 'Informed Data Systems Inc., 85 Delancey St, Ste 71, New York, US.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Raymond', 'Affiliation': 'University of Southern California, la southern ca, Los Angeles, US.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Huddleston', 'Affiliation': 'Informed Data Systems Inc., 85 Delancey St, Ste 71, New York, US.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Dachis', 'Affiliation': 'Informed Data Systems Inc., 85 Delancey St, Ste 71, New York, US.'}]",JMIR mHealth and uHealth,['10.2196/16745']
2186,32540878,Ultrasonographic needle tip tracking for in-plane infraclavicular brachialis plexus blocks: a randomized controlled volunteer study.,"BACKGROUND


Onvision is a new technology for needle tip detection and tracking in ultrasound-guided regional anesthesia. The system consists of a piezoelectric sensor close to the needle tip and an electronic console integrated in the ultrasound system. The needle tip is visualized by a green circle on the ultrasound screen. The aim of the study was to investigate the effect of the new needle tip tracking technology on in-plane infraclavicular plexus blocks.
METHODS


The study was a randomized, controlled, observer blinded cross-over trial in 26 healthy volunteers. Two specialists in anesthesiology performed an ultrasound-guided infraclavicular lateral sagittal brachial plexus block with and without needle tip tracking. Primary outcome was procedure time, measured from insertion of the needle until local anesthesia injection was completed. Secondary outcome measures included the number of hand movements and path lengths (assessed by hand motion analysis), block success rate, onset time and duration, discomfort experienced by the volunteers, and the anesthesiologists' confidence as to whether their block would be successful or not.
RESULTS


Mean (SD) procedure time was 183.0 (56.1) s with and 206.8 (56.2) s without needle tip tracking (p=0.16). There were no significant differences in any of the secondary outcomes. Two volunteers' experienced Horner syndrome after blocks without needle tip tracking. No other adverse events occurred during the study.
CONCLUSION


Our study on needle tip tracking for infraclavicular blocks did not reveal any significant differences between active needle tip tracking and the control procedures, neither for primary outcome nor secondary outcome measurements.
TRIAL REGISTRATION NUMBER


NCT03631914.",2020,"Our study on needle tip tracking for infraclavicular blocks did not reveal any significant differences between active needle tip tracking and the control procedures, neither for primary outcome nor secondary outcome measurements.
",['26 healthy volunteers'],"['new needle tip tracking technology', 'Ultrasonographic needle tip tracking', 'ultrasound-guided infraclavicular lateral sagittal brachial plexus block with and without needle tip tracking']","['Horner syndrome', 'Mean (SD) procedure time', 'adverse events', ""number of hand movements and path lengths (assessed by hand motion analysis), block success rate, onset time and duration, discomfort experienced by the volunteers, and the anesthesiologists' confidence as to whether their block would be successful or not"", 'procedure time, measured from insertion of the needle until local anesthesia injection']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0230108', 'cui_str': 'Infraclavicular region structure'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0394697', 'cui_str': 'Injection of anesthetic agent into brachial plexus'}]","[{'cui': 'C0019937', 'cui_str': 'Cervical sympathetic paralysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0449770', 'cui_str': 'Measured from'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]",26.0,0.0592287,"Our study on needle tip tracking for infraclavicular blocks did not reveal any significant differences between active needle tip tracking and the control procedures, neither for primary outcome nor secondary outcome measurements.
","[{'ForeName': 'Trine', 'Initials': 'T', 'LastName': 'Kåsine', 'Affiliation': 'Division of Emergencies and Critical Care, Department of Research and Development, Oslo University Hospital, Oslo, Norway trikaa@ous-hf.no.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Romundstad', 'Affiliation': 'Division of Emergencies and Critical Care, Department of Anesthesiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Rosseland', 'Affiliation': 'Division of Emergencies and Critical Care, Department of Research and Development, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Morten Wang', 'Initials': 'MW', 'LastName': 'Fagerland', 'Affiliation': 'Oslo Centre for Biostatics and Epidemiology (OCBE) Research Support Services, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kessler', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, Orthopedic University Hospital Friedrichsheim, Frankfurt am Main, Hessen, Germany.'}, {'ForeName': 'Ivar Nagelgaard', 'Initials': 'IN', 'LastName': 'Omenås', 'Affiliation': 'Division of Emergencies and Critical Care, Department of Anesthesiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Holmberg', 'Affiliation': 'Division of Emergencies and Critical Care, Department of Anesthesiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Axel R', 'Initials': 'AR', 'LastName': 'Sauter', 'Affiliation': 'Division of Emergencies and Critical Care, Department of Research and Development, Oslo University Hospital, Oslo, Norway.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2020-101349']
2187,32540886,"Understanding implementation success: protocol for an in-depth, mixed-methods process evaluation of a cluster randomised controlled trial testing methods to improve detection of Lynch syndrome in Australian hospitals.","INTRODUCTION


In multisite intervention trials, implementation success often varies widely across settings. Process evaluations are crucial to interpreting trial outcomes and understanding contextual factors and causal chains necessary for successful implementation. Lynch syndrome is a hereditary cancer predisposition conferring an increased risk of colorectal, endometrial and other cancer types. Despite systematic screening protocols to identify Lynch syndrome, the condition remains largely underdiagnosed. The Hide and Seek Project ('HaSP') is a cluster randomised controlled trial determining the effectiveness of two approaches to improving Lynch syndrome detection at eight Australian hospital networks. To enhance widespread implementation of optimal Lynch syndrome identification, there is a need to understand not only what works, but also why, in what contexts, and at what costs. Here we describe an in-depth investigation of factors influencing successful implementation of procedures evaluated in the HaSP trial.
METHODS AND ANALYSIS


A mixed-methods, theory-driven process evaluation will be undertaken in parallel to the HaSP trial. Data will include: interviews of Implementation Leads and Lynch syndrome stakeholders, pre-post implementation questionnaires, audio analysis of meetings and focus groups, observation of multidisciplinary team meetings, fidelity checklists and project log analysis. Results will be triangulated and coded, drawing on the Theoretical Domains Framework, Consolidated Framework for Implementation Research and Proctor's implementation outcomes.
ETHICS AND DISSEMINATION


Use of a theory-based process evaluation will enhance interpretation and generalisability of HaSP trial findings, and contribute to the implementation research field by furthering understanding of the conditions necessary for implementation success. Ethical approval has been granted and results will be disseminated via publications in peer-reviewed journals and conference presentations. At trial completion, key findings will be fed back to sites to enable refinement of intervention strategies, both in the context of Lynch syndrome and for the possible generalisability of intervention components in other genetic and broader clinical specialties.
HASP TRIAL REGISTRATION NUMBER


Australian New Zealand Clinical Trials Registry (Identifier: ACTRN12618001072202). Registered 27 June 2018. http://www.ANZCTR.org.au/ACTRN12618001072202.aspx.",2020,The Hide and Seek Project ('HaSP') is a cluster randomised controlled trial determining the effectiveness of two approaches to improving Lynch syndrome detection at eight Australian hospital networks.,['Australian hospitals'],[],[],"[{'cui': 'C0019994', 'cui_str': 'Hospitals'}]",[],[],,0.147946,The Hide and Seek Project ('HaSP') is a cluster randomised controlled trial determining the effectiveness of two approaches to improving Lynch syndrome detection at eight Australian hospital networks.,"[{'ForeName': 'April', 'Initials': 'A', 'LastName': 'Morrow', 'Affiliation': 'Cancer Council New South Wales, Woolloomooloo, New South Wales, Australia april.morrow@nswcc.org.au.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Tucker', 'Affiliation': 'Hereditary Cancer Clinic, Prince of Wales Hospital and Community Health Services, Randwick, New South Wales, Australia.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'Shaw', 'Affiliation': 'Research in Implementation Science and eHealth (RISe), Faculty of Health Sciences, University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Bonny', 'Initials': 'B', 'LastName': 'Parkinson', 'Affiliation': 'The Macquarie University Centre for the Health Economy, Macquarie University, Macquarie, New South Wales, Australia.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Abraham', 'Affiliation': 'Melbourne School of Psychological Sciences, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Wolfenden', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Taylor', 'Affiliation': 'Cancer Council New South Wales, Woolloomooloo, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-033552']
2188,32540887,"Effectiveness of breathing exercises, foot reflexology and back massage (BRM) on labour pain, anxiety, duration, satisfaction, stress hormones and newborn outcomes among primigravidae during the first stage of labour in Saudi Arabia: a study protocol for a randomised controlled trial.","INTRODUCTION


Labour pain is among the severest pains primigravidae may experience during pregnancy. Failure to address labour pain and anxiety may lead to abnormal labour. Despite the many complementary non-pharmacological approaches to coping with labour pain, the quality of evidence is low and best approaches are not established. This study protocol describes a proposed investigation of the effects of a combination of breathing exercises, foot reflexology and back massage (BRM) on the labour experiences of primigravidae.
METHODS AND ANALYSIS


This randomised controlled trial will involve an intervention group receiving BRM and standard labour care, and a control group receiving only standard labour care. Primigravidae of 26-34 weeks of gestation without chronic diseases or pregnancy-related complications will be recruited from antenatal clinics. Eligible and consenting patients will be randomly allocated to the intervention or the control group stratified by intramuscular pethidine use. The BRM intervention will be delivered by a trained massage therapist. The primary outcomes of labour pain and anxiety will be measured during and after uterine contractions at baseline (cervical dilatation 6 cm) and post BRM hourly for 2 hours. The secondary outcomes include maternal stress hormone (adrenocorticotropic hormone, cortisol and oxytocin) levels, maternal vital signs (V/S), fetal heart rate, labour duration, Apgar scores and maternal satisfaction. The sample size is estimated based on the between-group difference of 0.6 in anxiety scores, 95% power and 5% α error, which yields a required sample size of 154 (77 in each group) accounting for a 20% attrition rate. The between-group and within-group outcome measures will be examined with mixed-effect regression models, time series analyses and paired t-test or equivalent non-parametric tests, respectively.
ETHICS AND DISSEMINATION


Ethical approval was obtained from the Ethical Committee for Research Involving Human Subjects of the Ministry of Health in the Saudi Arabia (H-02-K-076-0319-109) on 14 April 2019, and from the Ethics Committee for Research Involving Human Subjects (JKEUPM) Universiti Putra Malaysia on 23 October 2019, reference number: JKEUPM-2019-169. Written informed consent will be obtained from all participants. Results from this trial will be presented at regional, national and international conferences and published in indexed journals.
TRIAL REGISTRATION NUMBER


ISRCTN87414969, registered 3 May 2019.",2020,Eligible and consenting patients will be randomly allocated to the intervention or the control group stratified by intramuscular pethidine use.,"['Eligible and consenting patients', 'primigravidae during the first stage of labour in Saudi Arabia', 'labour experiences of primigravidae', 'Human Subjects of the Ministry of Health in the Saudi Arabia (H-02-K-076-0319-109) on 14 April 2019, and from the Ethics Committee for Research Involving Human Subjects (JKEUPM', 'Primigravidae of 26-34 weeks of gestation without chronic diseases or pregnancy-related complications will be recruited from antenatal clinics']","['breathing exercises, foot reflexology and back massage (BRM', 'BRM and standard labour care, and a control group receiving only standard labour care', 'pethidine']","['labour pain and anxiety will be measured during and after uterine contractions at baseline (cervical dilatation 6\u2009cm) and post BRM hourly for 2\u2009hours', 'maternal stress hormone (adrenocorticotropic hormone, cortisol and oxytocin) levels, maternal vital signs (V/S), fetal heart rate, labour duration, Apgar scores and maternal satisfaction', 'mixed-effect regression models, time series analyses and paired t-test or equivalent non-parametric tests, respectively', 'labour pain, anxiety, duration, satisfaction, stress hormones and newborn outcomes']","[{'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022871', 'cui_str': 'First stage of labor'}, {'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0085546', 'cui_str': 'Ethics Committees'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}]","[{'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0034945', 'cui_str': 'Reflexology'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1171200', 'cui_str': 'Labor care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025376', 'cui_str': 'Meperidine'}]","[{'cui': 'C0474368', 'cui_str': 'Labor pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042130', 'cui_str': 'Uterine contraction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0558292', 'cui_str': 'Hourly'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0018811', 'cui_str': 'Fetal heart rate'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.157332,Eligible and consenting patients will be randomly allocated to the intervention or the control group stratified by intramuscular pethidine use.,"[{'ForeName': 'Kamilya Jamel', 'Initials': 'KJ', 'LastName': 'Baljon', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'Muhammad Hibatullah', 'Initials': 'MH', 'LastName': 'Romli', 'Affiliation': 'Department of Nursing & Rehabilitation, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'Adibah Hanim', 'Initials': 'AH', 'LastName': 'Ismail', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Khuan', 'Affiliation': 'Department of Nursing & Rehabilitation, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'Boon How', 'Initials': 'BH', 'LastName': 'Chew', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia chewboonhow@upm.edu.my.'}]",BMJ open,['10.1136/bmjopen-2019-033844']
2189,32540918,"Influences on memory for naturalistic visual episodes: sleep, familiarity, and traits differentially affect forms of recall.","The memories we form are composed of information that we extract from multifaceted episodes. Static stimuli and paired associations have proven invaluable stimuli for understanding memory, but real-life events feature spatial and temporal dimensions that help form new retrieval paths. We ask how the ability to recall semantic, temporal, and spatial aspects (the ""what, when, and where"") of naturalistic episodes is affected by three influences-prior familiarity, postencoding sleep, and individual differences-by testing their influence on three forms of recall: cued recall, free recall, and the extent that recalled details are recombined for a novel prompt. Naturalistic videos of events with rare animals were presented to 115 participants, randomly assigned to receive a 12- or 24-h delay with sleep and/or wakefulness. Participants' immediate and delayed recall was tested and coded by its spatial, temporal, and semantic content. We find that prior familiarity with items featured in events improved cued recall, but not free recall, particularly for temporal and spatial details. In contrast, postencoding sleep, relative to wakefulness, improved free recall, but not cued recall, of all forms of content. Finally, individuals with higher trait scores in the Survey of Autobiographical Memory spontaneously incorporated more spatial details during free recall, and more event details (at a trend level) in a novel recombination recall task. These findings show that prior familiarity, postencoding sleep, and memory traits can each enhance a different form of recall. More broadly, this work highlights that recall is heterogeneous in response to different influences on memory.",2020,"In contrast, postencoding sleep, relative to wakefulness, improved free recall, but not cued recall, of all forms of content.",['115 participants'],[],"['postencoding sleep, relative to wakefulness, improved free recall']","[{'cui': 'C4517540', 'cui_str': '115'}]",[],"[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]",115.0,0.0243675,"In contrast, postencoding sleep, relative to wakefulness, improved free recall, but not cued recall, of all forms of content.","[{'ForeName': 'Marc N', 'Initials': 'MN', 'LastName': 'Coutanche', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, Pennsylvania 15260, USA.'}, {'ForeName': 'Griffin E', 'Initials': 'GE', 'LastName': 'Koch', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, Pennsylvania 15260, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Paulus', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, Pennsylvania 15260, USA.'}]","Learning & memory (Cold Spring Harbor, N.Y.)",['10.1101/lm.051300.119']
2190,32540922,Association of Long-term Change and Variability in Glycemia With Risk of Incident Heart Failure Among Patients With Type 2 Diabetes: A Secondary Analysis of the ACCORD Trial.,"OBJECTIVE


To evaluate the associations between long-term change and variability in glycemia with risk of heart failure (HF) among patients with type 2 diabetes mellitus (T2DM).
RESEARCH DESIGN AND METHODS


Among participants with T2DM enrolled in the ACCORD trial, variability in HbA 1c  was assessed from stabilization of HbA 1c  following enrollment (8 months) to 3 years of follow-up as follows: average successive variability (ASV) (average absolute difference between successive values), coefficient of variation (SD/mean), and SD. Participants with HF at baseline or within 3 years of enrollment were excluded. Adjusted Cox models were used to evaluate the association of percent change (from baseline to 3 years of follow-up) and variability in HbA 1c  over the first 3 years of enrollment and subsequent risk of HF.
RESULTS


The study included 8,576 patients. Over a median follow-up of 6.4 years from the end of variability measurements at year 3, 388 patients had an incident HF hospitalization. Substantial changes in HbA 1c  were significantly associated with higher risk of HF (hazard ratio [HR] for ≥10% decrease 1.32 [95% CI 1.08-1.75] and for ≥10% increase 1.55 [1.19-2.04]; reference <10% change in HbA 1c ). Greater long-term variability in HbA 1c  was significantly associated with higher risk of HF (HR per 1 SD of ASV 1.34 [95% CI 1.17-1.54]) independent of baseline risk factors and interval changes in cardiometabolic parameters. Consistent patterns of association were observed with use of alternative measures of glycemic variability.
CONCLUSIONS


Substantial long-term changes and variability in HbA 1c  were independently associated with risk of HF among patients with T2DM.",2020,Substantial changes in HbA 1c  were significantly associated with higher risk of HF (hazard ratio [HR] for ≥10% decrease 1.32,"['Participants with HF at baseline or within 3 years of enrollment were excluded', '2 Diabetes', '8,576 patients', 'Among participants with T2DM enrolled in the ACCORD trial', 'patients with type 2 diabetes mellitus (T2DM', 'Patients With Type', 'patients with T2DM']",[],"['Glycemia', 'average successive variability (ASV', 'cardiometabolic parameters']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]",[],"[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0004429', 'cui_str': 'Avian sarcoma virus'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",8576.0,0.0476585,Substantial changes in HbA 1c  were significantly associated with higher risk of HF (hazard ratio [HR] for ≥10% decrease 1.32,"[{'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Segar', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Kershaw V', 'Initials': 'KV', 'LastName': 'Patel', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center, Department of Medicine, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Melissa C', 'Initials': 'MC', 'LastName': 'Caughey', 'Affiliation': 'Joint Department of Biomedical Engineering, University of North Carolina and North Carolina State University, Chapel Hill, NC.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson, MS.'}, {'ForeName': 'Gregg C', 'Initials': 'GC', 'LastName': 'Fonarow', 'Affiliation': 'Ahmanson-UCLA Cardiomyopathy Center, Division of Cardiology, Ronald Reagan UCLA Medical Center, Los Angeles, CA.'}, {'ForeName': 'Justin L', 'Initials': 'JL', 'LastName': 'Grodin', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Ambarish', 'Initials': 'A', 'LastName': 'Pandey', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX ambarish.pandey@utsouthwestern.edu.'}]",Diabetes care,['10.2337/dc19-2541']
2191,32540986,Improving HPV Vaccination Rates: A Stepped-Wedge Randomized Trial.,"OBJECTIVES


To evaluate the effectiveness of a stepped-wedge randomized trial of Development of Systems and Education for Human Papillomavirus Vaccination (DOSE HPV), a multilevel intervention.
METHODS


DOSE HPV is a 7-session program that includes interprofessional provider education, communication training, data feedback, and tailored systems change. Five primary care pediatric and/or family medicine practices completed interventions between 2016 and 2018; all chose to initiate vaccination at ages 9 to 10. We compared vaccination rates in the preintervention, intervention, and postintervention periods among 9- to 17-year-olds using random-effects generalized linear regression models appropriate for stepped-wedge design, accounting for calendar time and clustering of patients by providers and clinic. Outcomes included (1) the likelihood that eligible patients would receive vaccination during clinic visits; (2) the likelihood that adolescents would complete the series by age 13; and (3) the cumulative effect on population-level vaccine initiation and completion rates. Postintervention periods ranged from 6 to 18 months.
RESULTS


In the intervention and postintervention periods, the adjusted likelihood of vaccination at an eligible visit increased by >10 percentage points for ages 9 to 10 and 11 to 12, and completion of the vaccine series by age 13 increased by 4 percentage points ( P  < .001 for all comparisons). Population-level vaccine initiation coverage increased from 75% (preintervention) to 84% (intervention) to 90% (postintervention), and completion increased from 60% (preintervention) to 63% (intervention) to 69% (postintervention).
CONCLUSIONS


Multilevel interventions that include provider education, data feedback, tailored systems changes, and early initiation of the human papillomavirus vaccine series may improve vaccine series initiation and completion beyond the conclusion of the intervention period.",2020,"Population-level vaccine initiation coverage increased from 75% (preintervention) to 84% (intervention) to 90% (postintervention), and completion increased from 60% (preintervention) to 63% (intervention) to 69% (postintervention).
",['Five primary care pediatric and/or family medicine practices completed interventions between 2016 and 2018; all chose to initiate vaccination at ages 9 to 10'],['Systems and Education for Human Papillomavirus Vaccination (DOSE HPV'],"['vaccination rates', 'HPV Vaccination Rates', 'Population-level vaccine initiation coverage', 'cumulative effect on population-level vaccine initiation and completion rates']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",,0.0663215,"Population-level vaccine initiation coverage increased from 75% (preintervention) to 84% (intervention) to 90% (postintervention), and completion increased from 60% (preintervention) to 63% (intervention) to 69% (postintervention).
","[{'ForeName': 'Rebecca B', 'Initials': 'RB', 'LastName': 'Perkins', 'Affiliation': 'Departments of Obstetrics and Gynecology and rbperkin@bu.edu.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Legler', 'Affiliation': 'Pediatrics and Adolescent Medicine, School of Medicine, Boston University and Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Jansen', 'Affiliation': 'Continuing Medical Education Office.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Bernstein', 'Affiliation': 'Department of Health Law, Policy and Management, School of Public Health.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Pierre-Joseph', 'Affiliation': 'Pediatrics and Adolescent Medicine, School of Medicine, Boston University and Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Terresa J', 'Initials': 'TJ', 'LastName': 'Eun', 'Affiliation': 'Department of Sociology, Stanford University, Stanford, California.'}, {'ForeName': 'Dea L', 'Initials': 'DL', 'LastName': 'Biancarelli', 'Affiliation': 'Department of Health Law, Policy and Management, School of Public Health.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Schuch', 'Affiliation': 'South Boston Community Health Center, Boston, Massachusetts.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Leschly', 'Affiliation': 'East Boston Neighborhood Health Center, Boston, Massachusetts; and.'}, {'ForeName': 'Anny T H R', 'Initials': 'ATHR', 'LastName': 'Fenton', 'Affiliation': 'Center for Outcomes, Research, and Evaluation, Maine Medical Center Research Institute, Portland, Maine.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Adams', 'Affiliation': 'Pediatrics and Adolescent Medicine, School of Medicine, Boston University and Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Clark', 'Affiliation': 'Department of Health Law, Policy and Management, School of Public Health.'}, {'ForeName': 'Mari-Lynn', 'Initials': 'ML', 'LastName': 'Drainoni', 'Affiliation': 'Department of Health Law, Policy and Management, School of Public Health.'}, {'ForeName': 'Amresh', 'Initials': 'A', 'LastName': 'Hanchate', 'Affiliation': 'General Internal Medicine, Department of Medicine, and.'}]",Pediatrics,['10.1542/peds.2019-2737']
2192,32541083,Videoconference-Delivered Group-Based Physical Activity Self-Regulatory Support for Adults With Spinal Cord Injury: A Feasibility Study.,"Videoconferencing is a novel method for overcoming time and transportation barriers to leisure-time physical activity (LTPA) interventions. This study examined the feasibility of a group videoconference intervention on LTPA self-regulatory skills training in a sample of nine adults with spinal cord injury (SCI). Session implementation checklists and self-report surveys were administered during four weekly sessions to assess intervention management, group processes, intervention resources, and initial efficacy. Attendance rate was high (91.7%), and the average weekly session duration was 79.6 min. Participants reported high ratings of group cohesion, facilitator collaboration, session content comprehension, and ease in operating the videoconference platform. Knowledge sharing among the group ranged from 18 to 58 exchanges per session, demonstrating learning and group cohesion. LTPA frequency increased among 44% of participants, and 22% of participants achieved the SCI-specific aerobic guidelines. Overall, group videoconferencing holds promise for LTPA support among adults with SCI. Long-term research is warranted to test LTPA self-regulatory and behavioral effects.",2020,"Participants reported high ratings of group cohesion, facilitator collaboration, session content comprehension, and ease in operating the videoconference platform.","['nine adults with spinal cord injury\xa0(SCI', 'Adults With Spinal Cord Injury', 'adults with SCI']","['Videoconference-Delivered Group-Based Physical Activity Self-Regulatory Support', 'LTPA self-regulatory skills training', 'videoconference intervention', 'Videoconferencing']","['Attendance rate', 'high ratings of group cohesion, facilitator collaboration, session content comprehension, and ease in operating the videoconference platform', 'LTPA frequency']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}]","[{'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}]","[{'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",9.0,0.0180596,"Participants reported high ratings of group cohesion, facilitator collaboration, session content comprehension, and ease in operating the videoconference platform.","[{'ForeName': 'Samantha J D', 'Initials': 'SJD', 'LastName': 'Jeske', 'Affiliation': 'University of Toronto.'}, {'ForeName': 'Lawrence R', 'Initials': 'LR', 'LastName': 'Brawley', 'Affiliation': 'University of Saskatchewan.'}, {'ForeName': 'Kelly P', 'Initials': 'KP', 'LastName': 'Arbour-Nicitopoulos', 'Affiliation': 'University of Toronto.'}]",Adapted physical activity quarterly : APAQ,['10.1123/apaq.2019-0103']
2193,32541132,Hydrogen therapy can be used to control tumor progression and alleviate the adverse events of medications in patients with advanced non-small cell lung cancer.,"Chemotherapy, targeted therapy, and immunotherapy are used against advanced non-small cell lung cancer. A clinically efficacious method for relieving the adverse events associated of such therapies is lacking. Fifty-eight adult patients were enrolled in our trial to relieve pulmonary symptoms or the adverse events of drugs. Twenty patients who refused drug treatment were assigned equally and randomly to a hydrogen (H 2 )-only group and a control group. According to the results of tumor-gene mutations and drug-sensitivity tests, 10, 18, and 10 patients were enrolled into chemotherapy, targeted therapy, and immunotherapy groups in which these therapies were combined with H 2 -therapy, respectively. Patients underwent H 2  inhalation for 4-5 hours per day for 5 months or stopped when cancer recurrence. Before study initiation, the demographics (except for tumor-mutation genes) and pulmonary symptoms (except for moderate cough) of the five groups showed no significant difference. During the first 5 months of treatment, the prevalence of symptoms of the control group increased gradually, whereas that of the four treatment groups decreased gradually. After 16 months of follow-up, progression-free survival of the control group was lower than that of the H 2 -only group, and significantly lower than that of H 2  + chemotherapy, H 2  + targeted therapy, and H 2  + immunotherapy groups. In the combined-therapy groups, most drug-associated adverse events decreased gradually or even disappeared. H 2  inhalation was first discovered in the clinic that can be used to control tumor progression and alleviate the adverse events of medications for patients with advanced non-small cell lung cancer. This study was approved by the Ethics Committee of Fuda Cancer Hospital of Jinan University on December 7, 2018 (approval No. Fuda20181207), and was registered at ClinicalTrials.gov (Identifier: NCT03818347) on January 28, 2019.",2020,"After 16 months of follow-up, progression-free survival of the control group was lower than that of the H 2 -only group, and significantly lower than that of H 2  + chemotherapy, H 2  + targeted therapy, and H 2  + immunotherapy groups.","['patients with advanced non-small cell lung cancer', 'Fifty-eight adult patients were enrolled in our trial to relieve pulmonary symptoms or the adverse events of drugs', 'Fuda Cancer Hospital of Jinan University on December 7, 2018 (approval No. Fuda20181207), and was registered at ClinicalTrials.gov (Identifier: NCT03818347) on January 28, 2019', 'Twenty patients who refused drug treatment']","['Hydrogen therapy', 'hydrogen (H 2 )-only group and a control group', 'Chemotherapy, targeted therapy, and immunotherapy']","['pulmonary symptoms', 'adverse events', 'progression-free survival', 'prevalence of symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0019999', 'cui_str': 'Cancer hospital'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0017095', 'cui_str': 'Trash'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",58.0,0.0176589,"After 16 months of follow-up, progression-free survival of the control group was lower than that of the H 2 -only group, and significantly lower than that of H 2  + chemotherapy, H 2  + targeted therapy, and H 2  + immunotherapy groups.","[{'ForeName': 'Ji-Bing', 'Initials': 'JB', 'LastName': 'Chen', 'Affiliation': 'Fuda Cancer Hospital of Jinan University, Guangzhou; Fuda Cancer Institute, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Xiao-Feng', 'Initials': 'XF', 'LastName': 'Kong', 'Affiliation': 'Fuda Cancer Hospital of Jinan University, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Mu', 'Affiliation': 'Fuda Cancer Hospital of Jinan University, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Tian-Yu', 'Initials': 'TY', 'LastName': 'Lu', 'Affiliation': 'Fuda Cancer Hospital of Jinan University, Guangzhou; Fuda Cancer Institute, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'You-Yong', 'Initials': 'YY', 'LastName': 'Lu', 'Affiliation': 'Central Lab, Beijing Cancer Hospital, Beijing, China.'}, {'ForeName': 'Ke-Cheng', 'Initials': 'KC', 'LastName': 'Xu', 'Affiliation': 'Fuda Cancer Hospital of Jinan University, Guangzhou; Fuda Cancer Institute, Guangzhou, Guangdong Province, China.'}]",Medical gas research,['10.4103/2045-9912.285560']
2194,32541143,A Randomized Phase IIa Trial with Temsirolimus versus Sunitinib in Advanced Non-Clear Cell Renal Cell Carcinoma: An Intergroup Study of the CESAR Central European Society for Anticancer Drug Research-EWIV and the Interdisciplinary Working Group on Renal Cell Cancer (IAGN) of the German Cancer Society.,"BACKGROUND


Non-clear cell renal cell cancers (nccRCC) are rare entities, and the optimal therapy in metastatic disease has still to be defined.
METHODS


In this small prospectively randomized phase IIa multicenter trial, we investigated temsirolimus (TEM) versus sunitinib (SUN) as first-line therapy in patients with metastatic nccRCC. The patients were randomized 1:1 to either TEM in a dose of 25 mg i.v. once a week or SUN with 50 mg p.o. daily for 4 weeks on and 2 weeks off. Primary endpoint was progression-free survival (PFS). In total, 22 patients were included with predominantly papillary RCC (16/22) followed by chromophobe RCC and others.
RESULTS


The male to female ratio was 16:6. The tumor control rate (CR + PR + SD) was 58% for TEM and 90% for SUN-treated patients. There was also a trend for improved PFS with 9.3 versus 13.2 months (HR 1.64; 95% CI 0.65-4.18) in favor of SUN. There was no trend for overall survival.
CONCLUSIONS


Despite this trial had to be terminated earlier due to low recruitment, the results match the other studies published so far with the mTOR inhibitor everolimus and SUN, which show a trend in favor of SUN for ORR and PFS.",2020,The tumor control rate (CR + PR + SD) was 58% for TEM and 90% for SUN-treated patients.,"['patients with metastatic nccRCC', 'Advanced Non-Clear Cell Renal Cell Carcinoma', '22 patients were included with predominantly papillary RCC (16/22) followed by chromophobe RCC and others']","['TEM', 'temsirolimus (TEM) versus sunitinib (SUN', 'Temsirolimus versus Sunitinib']","['progression-free survival (PFS', 'overall survival', 'PFS', 'tumor control rate (CR + PR + SD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0279702', 'cui_str': 'Clear cell carcinoma of kidney'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205312', 'cui_str': 'Papillary'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0450329', 'cui_str': '16/22'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C1707080', 'cui_str': 'temsirolimus'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",22.0,0.176986,The tumor control rate (CR + PR + SD) was 58% for TEM and 90% for SUN-treated patients.,"[{'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Bergmann', 'Affiliation': 'Medical Clinic II, J.W. Goethe University, Frankfurt, Germany, L.Bergmann@em.uni-frankfurt.de.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Grünwald', 'Affiliation': 'Hematology and Medical Oncology, Medizinische Hochschule Hannover, Hannover, Germany.'}, {'ForeName': 'Luise', 'Initials': 'L', 'LastName': 'Maute', 'Affiliation': 'Medical Clinic II, J.W. Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Marc-Oliver', 'Initials': 'MO', 'LastName': 'Grimm', 'Affiliation': 'Clinic for Urology, Friedrich-Schiller University, Jena, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Weikert', 'Affiliation': 'Clinic for Urology, Vivantes Humboldt-Klinikum, Berlin, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Schleicher', 'Affiliation': 'Clinic for Hematology and Oncology, Klinikum Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Theodor', 'Initials': 'T', 'LastName': 'Klotz', 'Affiliation': 'Clinic for Urology and Andrology, Kliniken Nordoberpfalz AG, Weiden, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Greiner', 'Affiliation': 'Clinic for Hematology and Oncology, Diakonie Klinikum, Stuttgart, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Flörcken', 'Affiliation': 'Department of Hematology, Oncology, and Tumor Immunology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Virchow-Klinikum, Berlin, Germany.'}, {'ForeName': 'Arndt', 'Initials': 'A', 'LastName': 'Hartmann', 'Affiliation': 'Institut for Pathology, University Hospital, Erlangen-Nürnberg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gauler', 'Affiliation': 'Department of Medical Oncology, West German Cancer Center, University Hospital Essen of the University Duisburg-Essen, Essen, Germany.'}]",Oncology research and treatment,['10.1159/000508450']
2195,32541171,"Randomized, Double-Blind, Placebo-Controlled Phase Ⅱ Study on the Efficacy and Safety of Vitamin K1 Ointment for Cetuximab or Panitumumab-Induced Acneiform Eruptions-VIKTORIA Study.","PURPOSE


Skin toxicities associated with anti-epidermal growth factor receptor(EGFR)antibodies, have a profound effect on the continuation of treatment. We assessed the efficacy and safety of vitamin K1(VK1)ointment for acneiform eruptions induced by anti-EGFR antibody treatment.
METHODS


The VK1 ointment was applied to one-half of an affected area and placebo ointment was applied to the other half twice a day for 8 weeks, with photography and clinical evaluation being performed every 2 weeks. The primary endpoint was the change of the VK1/placebo ratio for the number of acneiform eruptions counted by an independent dermatologist between the onset and end of the treatment period.
RESULTS


A total of 30 patients were enrolled. The mean VK1/placebo ratio for the number of acneiform eruptions between the onset and end of the treatment period was -0.158±0.680 and 0.146±0.575, respectively, which was not statistically significant(p=0.069). The mean number of acneiform eruptions at each treatment period at the VK1 and placebo application sites was gradually decreased according to the treatment period.
CONCLUSION


VK1 ointment was not effective against acneiform eruptions induced by treatment with cetuximab or panitumumab. Reassessment of the VK1 concentration in the ointment and the endpoint of skin lesions is required before designing further studies.",2020,VK1 ointment was not effective against acneiform eruptions induced by treatment with cetuximab or panitumumab.,['30 patients were enrolled'],"['Vitamin K1 Ointment for Cetuximab or Panitumumab', 'vitamin K1(VK1)ointment', 'VK1 ointment', 'Placebo', 'placebo ointment', 'cetuximab or panitumumab']","['change of the VK1/placebo ratio for the number of acneiform eruptions', 'effective against acneiform eruptions', 'efficacy and safety', 'mean number of acneiform eruptions', 'mean VK1/placebo ratio for the number of acneiform eruptions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0031862', 'cui_str': 'Vitamin K 1'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175167', 'cui_str': 'Acneiform eruption'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",30.0,0.123209,VK1 ointment was not effective against acneiform eruptions induced by treatment with cetuximab or panitumumab.,"[{'ForeName': 'Hironobu', 'Initials': 'H', 'LastName': 'Hashimoto', 'Affiliation': 'Dept. of Pharmacy, National Cancer Center Hospital.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Iwasa', 'Affiliation': ''}, {'ForeName': 'Takako', 'Initials': 'T', 'LastName': 'Yanai-Takahashi', 'Affiliation': ''}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Honma', 'Affiliation': ''}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kato', 'Affiliation': ''}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Hamaguchi', 'Affiliation': ''}, {'ForeName': 'Yasuhide', 'Initials': 'Y', 'LastName': 'Yamada', 'Affiliation': ''}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Shimada', 'Affiliation': ''}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Yamazaki', 'Affiliation': ''}, {'ForeName': 'Yasuhisa', 'Initials': 'Y', 'LastName': 'Kato', 'Affiliation': ''}]",Gan to kagaku ryoho. Cancer & chemotherapy,[]
2196,32521324,"Evaluation of the impact of a nurse-led program of systematic screening of comorbidities in patients with axial spondyloarthritis: The results of the COMEDSPA prospective, controlled, one year randomized trial.","OBJECTIVE


To evaluate the impact of a nurse-led program of systematic screening for the management (detection/prevention) of comorbidities.
METHODS


Prospective, randomized, controlled, open, 12-month trial (NCT02374749).
PARTICIPANTS


consecutive patients with axial Spondyloarthritis (axSpA) (according to the rheumatologist) THE PROGRAM: A nurse collected data on comorbidities during a specific outpatient visit. In the event of non-agreement with recommendations, the patient was informed and a specific recommendation was given to the patient (orally and in a with a detailed written report). Patients were seen after one year in a nurse-led visit. TREATMENT ALLOCATION: random allocation (i.e. either this program or an educational program not presented here and considered here as the control group).
MAIN OUTCOME


change after one year of a weighted comorbidity management score (0 to 100 where 0= optimal management).
RESULTS


502 patients were included (252 and 250 in the active and control groups, respectively): age: 47±12 years, male gender: 63%, disease duration: 14±11y. After one year, no differences were observed in a weighted comorbidity management score. However, the number of patients in agreement with recommendations was significantly higher in the active group for vaccinations (flu vaccination: 28.6% vs. 9.9%, p<0.01; pneumococcal vaccination:40.0% vs. 21.1%,p=0.04), for cancer screening (skin cancer screening: 36.3% vs. 17.2%, p=0.04) and for osteoporosis (bone densitometry performed: 22.6% vs. 8.7%, p<0.01; Vitamin D supplementation initiation: 51.9% vs. 9.4%, p<0.01).
CONCLUSIONS AND RELEVANCE


This study suggests the short-term benefit of a single-visit nurse-led program for systematic screening of comorbidities for its management in agreement with recommendations, even in this young population of patients with axSpA.",2020,"However, the number of patients in agreement with recommendations was significantly higher in the active group for vaccinations (flu vaccination: 28.6% vs. 9.9%, p<0.01; pneumococcal vaccination:40.0% vs. 21.1%,p=0.04), for cancer screening (skin cancer screening: 36.3% vs. 17.2%, p=0.04) and for osteoporosis (bone densitometry performed: 22.6% vs. 8.7%, p<0.01; Vitamin D supplementation initiation: 51.9% vs. 9.4%, p<0.01).
","['consecutive patients with axial Spondyloarthritis (axSpA) (according to the rheumatologist) THE PROGRAM', 'patients with axial spondyloarthritis', '502 patients were included (252 and 250 in the active and control groups, respectively): age: 47±12 years, male gender: 63%, disease duration: 14±11y', 'young population of patients with axSpA']","['nurse-led program of systematic screening', 'nurse-led program', 'single-visit nurse-led program']",['weighted comorbidity management score'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis'}, {'cui': 'C0334889', 'cui_str': 'Rheumatologist'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042799', 'cui_str': 'Home Nurses'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",502.0,0.0692749,"However, the number of patients in agreement with recommendations was significantly higher in the active group for vaccinations (flu vaccination: 28.6% vs. 9.9%, p<0.01; pneumococcal vaccination:40.0% vs. 21.1%,p=0.04), for cancer screening (skin cancer screening: 36.3% vs. 17.2%, p=0.04) and for osteoporosis (bone densitometry performed: 22.6% vs. 8.7%, p<0.01; Vitamin D supplementation initiation: 51.9% vs. 9.4%, p<0.01).
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Molto', 'Affiliation': 'Rheumatology Department, Cochin Hospital, Assistance Publique Hôpitaux de Paris, Paris, France; Université de Paris, INSERM U-1153, CRESS, Paris, France. Electronic address: anna.molto@aphp.fr.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Gossec', 'Affiliation': 'Sorbonne Université, IPLESP, INSERM, Paris France; Pitié Salpêtrière hospital, APHP, Rheumatology department, Paris, France.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Poiraudeau', 'Affiliation': 'Rehabilitation and Physical Medicine Department, Cochin Hospital, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Claudepierre', 'Affiliation': 'Rheumatology Department, Henri Mondor Hospital, Assistance Publique Hôpitaux de Paris, and Université Paris Est Créteil, EA, 7379 - EpidermE, F-94010, Créteil, France.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Soubrier', 'Affiliation': 'Rheumatology Department, CHU Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Fayet', 'Affiliation': 'Rheumatology Department, CHU Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wendling', 'Affiliation': 'Rheumatology Department, CHRU de BESANCON, University Teaching Hospital, and Université Bourgogne Franche-Comté, EA4266 (EPILAB), Besançon, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gaudin', 'Affiliation': 'Rheumatology Department, CHU Grenoble, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Dernis', 'Affiliation': 'Rheumatology Department, CH Le Mans, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Guis', 'Affiliation': 'Rheumatology Department, CHU Marseille, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Pouplin', 'Affiliation': 'Rheumatology Department, CHU Rouen, France.'}, {'ForeName': 'Adeline', 'Initials': 'A', 'LastName': 'Ruyssen', 'Affiliation': 'Centre de Rhumatologie, Hôpital Purpan, Toulouse, et Faculté de Médecine, Université Toulouse III, Paul Sabatier University, Toulouse, France.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Chales', 'Affiliation': 'Medecine Faculty, Department of Rheumatology, South Hospital, Rennes 1 University, Rennes, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Mariette', 'Affiliation': 'Rheumatology Department, APHP, Bicêtre Hospital, Le Kremlin-Bicetre, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Beauvais', 'Affiliation': 'Rheumatology Department, Saint Antoine Hospital, APHP, Paris, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Combe', 'Affiliation': 'Rheumatology department, CHU Montpellier, Montpellier University, Montpellier, France.'}, {'ForeName': 'René-Marc', 'Initials': 'RM', 'LastName': 'Flipo', 'Affiliation': 'Rheumatology Department, CHU Roger Salengro Hospital, University of Lille, Lille, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Richette', 'Affiliation': 'Université Paris Diderot, UFR médicale, Paris, France; APHP Hôpital Lariboisiére, Fédération de Rhumatologie, Paris, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Chary-Valckenaere', 'Affiliation': 'Department of Rheumatology, Nancy Hospital, Nancy, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Saraux', 'Affiliation': 'Rheumatology Unit, UMR1227 (Lymphocytes B et Autoimmunité), Université de Brest, Inserm, CHU Brest, LabEx IGO, Brest, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Sibilia', 'Affiliation': 'Department of Rheumatology, Hautepierre CHU, Fédération de médecine translationnelle, UMR INSERM 1109, Strasbourg, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Schaeverbeke', 'Affiliation': 'Rheumatology Department, Pellegrin Hospital, Bordeaux, France.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Dougados', 'Affiliation': 'Rheumatology Department, Cochin Hospital, Assistance Publique Hôpitaux de Paris, Paris, France; Université de Paris, INSERM U-1153, CRESS, Paris, France.'}]",Seminars in arthritis and rheumatism,['10.1016/j.semarthrit.2020.05.012']
2197,32521358,Protocol for a partially nested randomised controlled trial to evaluate the effectiveness of the scleroderma patient-centered intervention network COVID-19 home-isolation activities together (SPIN-CHAT) program to reduce anxiety among at-risk scleroderma patients.,"OBJECTIVE


Contagious disease outbreaks and related restrictions can lead to negative psychological outcomes, particularly in vulnerable populations at risk due to pre-existing medical conditions. No randomised controlled trials (RCTs) have tested interventions to reduce mental health consequences of contagious disease outbreaks. The primary objective of the Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Trial is to evaluate the effect of a videoconference-based program on symptoms of anxiety. Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction.
METHODS


The SPIN-CHAT Trial is a pragmatic RCT that will be conducted using the SPIN-COVID-19 Cohort, a sub-cohort of the SPIN Cohort. Eligible participants will be SPIN-COVID-19 Cohort participants without a positive COVID-19 test, with at least mild anxiety (PROMIS Anxiety 4a v1.0 T-score ≥ 55), not working from home, and not receiving current counselling or psychotherapy. We will randomly assign 162 participants to intervention groups of 7 to 10 participants each or waitlist control. We will use a partially nested RCT design to reflect dependence between individuals in training groups but not in the waitlist control. The SPIN-CHAT Program includes activity engagement, education on strategies to support mental health, and mutual participant support. Intervention participants will receive the 4-week (3 sessions per week) SPIN-CHAT Program via videoconference. The primary outcome is PROMIS Anxiety 4a score immediately post-intervention.
ETHICS AND DISSEMINATION


The SPIN-CHAT Trial will test whether a brief videoconference-based intervention will improve mental health outcomes among at-risk individuals during contagious disease outbreak.",2020,"Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction.
","['Eligible participants will be SPIN-COVID-19 Cohort participants without a positive COVID-19 test, with at least mild anxiety (PROMIS Anxiety 4a v1.0 T-score\u202f≥\u202f55), not working from home, and not receiving current counselling or psychotherapy', '162 participants to intervention groups of 7 to 10 participants each or', 'at-risk scleroderma patients']","['Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities', 'videoconference-based intervention', 'scleroderma patient-centered intervention network COVID-19 home-isolation activities together (SPIN-CHAT) program', 'Together (SPIN-CHAT', 'waitlist control', 'videoconference-based program']","['symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction', 'PROMIS Anxiety 4a score immediately post-intervention', 'mental health outcomes', 'symptoms of anxiety']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0231401', 'cui_str': 'Mild anxiety'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0006019', 'cui_str': 'Boredom'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037420', 'cui_str': 'Interaction with others'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",162.0,0.100017,"Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction.
","[{'ForeName': 'Brett D', 'Initials': 'BD', 'LastName': 'Thombs', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada; Department of Medicine, McGill University, Montreal, Quebec, Canada; Department of Psychology, McGill University, Montreal, Quebec, Canada; Department of Educational and Counselling Psychology, McGill University, Montreal, Quebec, Canada; Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada. Electronic address: brett.thombs@mcgill.ca.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Kwakkenbos', 'Affiliation': 'Department of Clinical Psychology, Behavioural Science Institute, Radboud University, Nijmegen, the Netherlands.'}, {'ForeName': 'Marie-Eve', 'Initials': 'ME', 'LastName': 'Carrier', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Bourgeault', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Tao', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Harb', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Gagarine', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Rice', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychology, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bustamante', 'Affiliation': 'Department of Applied Human Sciences, Concordia University, Montreal, Quebec, Canada.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Ellis', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Delaney', 'Initials': 'D', 'LastName': 'Duchek', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Parash Mani', 'Initials': 'PM', 'LastName': 'Bhandari', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Dipika', 'Initials': 'D', 'LastName': 'Neupane', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Carboni-Jiménez', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Henry', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Ankur', 'Initials': 'A', 'LastName': 'Krishnan', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Levis', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada; Centre for Prognosis Research, School of Primary, Community and Social Care, Keele University, Staffordshire, UK.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'He', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Turner', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Benedetti', 'Affiliation': 'Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada; Department of Medicine, McGill University, Montreal, Quebec, Canada; Respiratory Epidemiology and Clinical Research Unit, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Culos-Reed', 'Affiliation': 'Department of Applied Human Sciences, Concordia University, Montreal, Quebec, Canada; Department of Oncology, Cumming School of Medicine, Calgary, Canada; Department of Psychosocial Resources, Tom Baker Cancer Centre, Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Ghassan', 'Initials': 'G', 'LastName': 'El-Baalbaki', 'Affiliation': 'Department of Psychology, Université du Québec à Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Hebblethwaite', 'Affiliation': 'Department of Applied Human Sciences, Concordia University, Montreal, Quebec, Canada.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Bartlett', 'Affiliation': 'Department of Medicine, McGill University, Montreal, Quebec, Canada; Research Institute, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dyas', 'Affiliation': 'Scleroderma Foundation Michigan Chapter, Southfield, MI, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Patten', 'Affiliation': ""Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada; Hotchkiss Brain Institute and O'Brien Institute for Public Health, University of Calgary, Calgary, Alberta, Canada.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Varga', 'Affiliation': 'Northwestern Scleroderma Program, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110132']
2198,32521394,Effects of perioperative magnesium sulfate infusion on intraoperative blood loss and postoperative analgesia in patients undergoing posterior lumbar spinal fusion surgery: A randomized controlled trial.,"OBJECTIVE


Many studies have suggested the anti-nociceptive role for magnesium either as an adjunct for postoperative pain. Although several studies have been carried out to evaluate the anti-nociceptive effect of magnesium, there is still considerable uncertainty.
PATIENTS AND METHODS


Eighty patients who underwent posterior spinal fusion were randomly divided into two groups (magnesium and saline). Changes in cell count, magnesium concentration and coagulation status were assessed one hour after operation at both group and compared to baseline. At recovery room, their pain score was assessed according to 10 points visual analogue scale (VAS). Morphine consumption was evaluated at regular times after the surgery by patient controlled analgesia (PCA) device.
RESULTS


VAS scores were significantly lower in the magnesium group. Cumulative PCA morphine consumption after the surgery was significantly lower in the magnesium group. Pre and postoperative values for haemoglobin, platelet count, Prothrombin Time (PT), fibrinogen were not significantly different. There was a significant increase in activated Partial Thromboplastin Time (aPTT), International Normalized Ratio (INR), and bleeding time (BT), one hour after the operation in the magnesium group but intraoperative blood loss was similar in both groups.
CONCLUSIONS


Perioperative magnesium sulfate infusion improves the postoperative analgesia, decreases the amount of morphine consumption after the operation and does not change the intraoperative bleeding in patients undergoing posterior spinal fusion surgery.",2020,"Pre and postoperative values for haemoglobin, platelet count, Prothrombin Time (PT), fibrinogen were not significantly different.","['patients undergoing posterior spinal fusion surgery', 'Eighty patients who underwent posterior spinal fusion', 'patients undergoing posterior lumbar spinal fusion surgery']","['Perioperative magnesium sulfate infusion', 'magnesium and saline', 'magnesium', 'perioperative magnesium sulfate infusion']","['postoperative analgesia', 'intraoperative bleeding', 'Pre and postoperative values for haemoglobin, platelet count, Prothrombin Time (PT), fibrinogen', 'morphine consumption', 'cell count, magnesium concentration and coagulation status', 'Morphine consumption', 'intraoperative blood loss', 'pain score', 'activated Partial Thromboplastin Time (aPTT), International Normalized Ratio (INR), and bleeding time (BT', 'Cumulative PCA morphine consumption', 'intraoperative blood loss and postoperative analgesia', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0919636', 'cui_str': 'Spinal fusion surgery'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0037935', 'cui_str': 'Spinal arthrodesis'}, {'cui': 'C0186045', 'cui_str': 'Lumbar spinal fusion'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C0005729', 'cui_str': 'Bleeding time'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",80.0,0.140799,"Pre and postoperative values for haemoglobin, platelet count, Prothrombin Time (PT), fibrinogen were not significantly different.","[{'ForeName': 'Masih Ebrahimy', 'Initials': 'ME', 'LastName': 'Dehkordy', 'Affiliation': 'Department of Anesthesiology, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Roozbeh', 'Initials': 'R', 'LastName': 'Tavanaei', 'Affiliation': 'Shohada Tajrish Neurosurgical Center of Excellence, Functional Neurosurgery Research Center, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Younesi', 'Affiliation': 'Department of Anesthesiology, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shayesteh', 'Initials': 'S', 'LastName': 'Khorasanizade', 'Affiliation': 'Department of Anesthesiology, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamidreza Azizi', 'Initials': 'HA', 'LastName': 'Farsani', 'Affiliation': 'Department of Anesthesiology, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Oraee-Yazdani', 'Affiliation': 'Shohada Tajrish Neurosurgical Center of Excellence, Functional Neurosurgery Research Center, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: Saeed_o_yazdani@sbmu.ac.ir.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.105983']
2199,32521448,Design cues for tobacco communication: Heuristic interpretations and usability of online health information about harmful chemicals.,"OBJECTIVE


Many people have a poor understanding of the numerous chemicals in tobacco products that cause severe health harms. The US government must display a list of these harmful chemicals for the public. Online disclosures are one promising solution, but evidence is needed for effective design strategies to encourage interpretation and use of information as intended.
METHOD


To examine the impact of website designs for the activation of heuristics and usability perceptions, a national probability sample of US adolescents and adults (n = 1441) was randomized in a 3 (chemical format) × 2 (webpage layout) between-subjects online experiment. Chemicals were displayed as names only, with a visual risk indicator, or with numerical ranges. Layouts displayed health harms at the top of the webpage separate from chemicals or the chemicals grouped by associated health harms. Participants viewed a webpage and reported activated heuristics, usability (perceived ease of use and usefulness), and intentions to use the website.
RESULTS


Displaying risk indicators increased website usability by encouraging users to rely on colors to interpret the risk of the chemicals (all p < .01). Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
CONCLUSION


Assessing heuristics gives insights for how US adolescents and adults interpret chemical information and the impact of design strategies on usability. Public disclosures of chemicals in tobacco products could be optimized with color-coded risk indicators and layouts placing chemicals near the harms they cause.",2020,"Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
",['US adolescents and adults (n = 1441'],[],['website usability'],"[{'cui': 'C0002838', 'cui_str': 'Andorra'}]",[],[],1441.0,0.0625486,"Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
","[{'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Lazard', 'Affiliation': 'School of Media and Journalism, University of North Carolina at Chapel Hill, NC 27599-3365, United States; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, NC 27599-3365, United States. Electronic address: lazard@unc.edu.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104177']
2200,32521472,Improvement of dynamic postural stability by an exercise program.,"BACKGROUND


Central processing of multi-sensory feedback and motor commands responsible for force production are critical for postural control. An exercise program was developed to realign spinal curvature, but its effect on postural control is unknown.
RESEARCH QUESTION


To what extent would the exercise program influence on center of pressure (CoP) sway on stable and unstable surfaces?
METHODS


Subjects (n = 30) were randomly assigned into one of three groups: exercise on a cylinder-shaped tube (98-cm length, 15-cm diameter, n = 10), exercise on a flat surface (n = 10), and a control group that laid supine on a flat surface (n = 10). Standing posture of each subject was quantified using anterior-, posterior-, and lateral-view photography. Each subject's CoP sway was measured while standing on a static and dynamic platform with eyes open and eyes closed. Subjects were instructed to stand still when the platform was held stationary (e.g., no tilt) during the static condition. During the dynamic condition the platform was allowed to tilt in response to changes of CoP and subjects were instructed to maintain the platform in a horizontal position.
RESULTS


Only when subjects performed the exercise program on the tube, the angles of neck flexion and pelvis tilt decreased, and CoP sway in the sagittal, but not frontal plane, decreased during the dynamic platform conditions with both eyes open and eyes closed (p < 0.05).
SIGNIFICANCE


It is speculated that performing the exercise program on the tube might enhance a) central processing of somatosensory and vestibular inputs, b) motor commands responsible for force production in postural control, and c) biomechanical advantage by the realigned posture. The exercise program can be used by a variety of populations as home-exercise to realign the neck and pelvic posture and improve dynamic postural stability.",2020,"Only when subjects performed the exercise program on the tube, the angles of neck flexion and pelvis tilt decreased, and CoP sway in the sagittal, but not frontal plane, decreased during the dynamic platform conditions with both eyes open and eyes closed (p < 0.05).
",['Subjects (n\u202f=\u202f30'],"['exercise on a cylinder-shaped tube (98-cm length, 15-cm diameter, n\u202f=\u202f10), exercise on a flat surface (n\u202f=\u202f10), and a control group that laid supine']","['dynamic postural stability', 'neck flexion and pelvis tilt decreased, and CoP sway']",[],"[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0181797', 'cui_str': 'Medical gas cylinder'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0445088', 'cui_str': 'Neck flexion'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",30.0,0.0135493,"Only when subjects performed the exercise program on the tube, the angles of neck flexion and pelvis tilt decreased, and CoP sway in the sagittal, but not frontal plane, decreased during the dynamic platform conditions with both eyes open and eyes closed (p < 0.05).
","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Shibata', 'Affiliation': 'Athletic Training Education Program, Department of Health Exercise and Sports Sciences, University of New Mexico, New Mexico, USA. Electronic address: diceshibata@unm.edu.'}]",Gait & posture,['10.1016/j.gaitpost.2020.05.044']
2201,32522811,Interventions supporting long term adherence and decreasing cardiovascular events after myocardial infarction (ISLAND): pragmatic randomised controlled trial.,"OBJECTIVE


To test a scalable health system intervention to improve long term adherence to secondary prevention treatments among patients who have had a recent myocardial infarction.
DESIGN


Three arm, pragmatic randomised controlled trial with blinded outcome assessment.
SETTING


Nine cardiac centres in Ontario, Canada.
PARTICIPANTS


2632 patients with obstructive coronary artery disease after a myocardial infarction, identified from a centralised cardiac registry.
INTERVENTIONS


Participants were randomised 1:1:1 to receive usual care, five mail-outs developed through a user centred design process, or mail-outs plus phone calls. The phone calls were delivered first by an interactive automated system to screen for non-adherence to treatment. Trained lay health workers followed up as necessary. Interventions were coordinated centrally but delivered from each patient's hospital site.
MAIN OUTCOME MEASURES


Co-primary outcomes were completion of cardiac rehabilitation and adherence to recommended medication. Data were collected by blinded assessors through patient report and from administrative health databases at 12 months.
RESULTS


2632 patients (mean age 66, 71% male) were randomised: 878 to the full intervention (mail plus phone calls), 878 to mail only, and 876 to usual care. Of the respondents, 174 (27%) of 643 in the usual care group, 200 (32%) of 628 in the mail only group, and 196 (37%) of 531 allocated to the full intervention completed cardiac rehabilitation (adjusted odds ratio 1.55, 95% confidence interval 1.18 to 2.03). In the mail plus phone group, 11.7%, 6.0%, 14.4%, 32.9%, and 35.0% reported adherence to 0, 1, 2, 3, and 4 drug classes after one year, respectively, in comparison with 12.5%, 6.8%, 13.6%, 30.2%, and 36.8% in the mail only group, and 12.2%, 8.4%, 13.1%, 30.3%, and 36.1% in the usual care group, respectively (mail only  v  usual care, odds ratio 0.98, 95% confidence interval 0.81 to 1.19; full intervention  v  usual care, 0.99, 0.82 to 1.20).
CONCLUSIONS


Scalable interventions delivered by mail plus phone can increase completion of cardiac rehabilitation after myocardial infarction but not adherence to medication. More intensive interventions should be tested to improve adherence to medication and to evaluate the association between attendance at cardiac rehabilitation and adherence to medication.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02382731, registered 9 March 2015 before any patient enrolment.",2020,"More intensive interventions should be tested to improve adherence to medication and to evaluate the association between attendance at cardiac rehabilitation and adherence to medication.
","['2632 patients with obstructive coronary artery disease after a myocardial infarction, identified from a centralised cardiac registry', 'Nine cardiac centres in Ontario, Canada', '2632 patients (mean age 66, 71% male) were randomised: 878 to the', 'patients who have had a recent myocardial infarction']","['full intervention (mail plus phone calls', 'usual care, five mail-outs developed through a user centred design process, or mail-outs plus phone calls']","['cardiovascular events', 'cardiac rehabilitation', 'completion of cardiac rehabilitation and adherence to recommended medication']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1998297', 'cui_str': 'Recent myocardial infarction'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0439787', 'cui_str': 'Out'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C1522240', 'cui_str': 'Process'}]","[{'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",2632.0,0.141035,"More intensive interventions should be tested to improve adherence to medication and to evaluate the association between attendance at cardiac rehabilitation and adherence to medication.
","[{'ForeName': 'Noah M', 'Initials': 'NM', 'LastName': 'Ivers', 'Affiliation': ""Department of Family and Community Medicine, Women's College Hospital, 76 Grenville Street, Toronto, ON, M5S1B2, Canada noah.ivers@utoronto.ca.""}, {'ForeName': 'Jon-David', 'Initials': 'JD', 'LastName': 'Schwalm', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Bouck', 'Affiliation': ""Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'McCready', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Taljaard', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Sherry L', 'Initials': 'SL', 'LastName': 'Grace', 'Affiliation': 'Faculty of Health, York University, Toronto, ON, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Cunningham', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Bosiak', 'Affiliation': ""Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Presseau', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Holly O', 'Initials': 'HO', 'LastName': 'Witteman', 'Affiliation': 'Department of Family and Emergency Medicine, Université Laval, Quebec City, QC, Canada.'}, {'ForeName': 'Neville', 'Initials': 'N', 'LastName': 'Suskin', 'Affiliation': ""Cardiac Rehabilitation and Secondary Prevention Programme of St Joseph's Health Care London, ON, Canada.""}, {'ForeName': 'Harindra C', 'Initials': 'HC', 'LastName': 'Wijeysundera', 'Affiliation': 'Institute for Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Atzema', 'Affiliation': 'Institute for Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'R Sacha', 'Initials': 'RS', 'LastName': 'Bhatia', 'Affiliation': ""Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Madhu', 'Initials': 'M', 'LastName': 'Natarajan', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Grimshaw', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}]",BMJ (Clinical research ed.),['10.1136/bmj.m1731']
2202,32151227,Dietary nitrate supplementation effect on dynamic cerebral autoregulation in normoxia and acute hypoxia.,"We tested the hypothesis that increasing the nitric oxide (NO) bioavailability by dietary nitrate would recover the hypoxia-induced reduction in dynamic cerebral autoregulation (CA). Twelve healthy males (age 21 ± 2 years) completed four days of dietary supplementation with a placebo or inorganic nitrate drink (140-ml beetroot juice per day) followed by 60-min of normoxia or hypoxia (fraction of inspired oxygen [FiO 2 ] = 13%). Duplex ultrasonography was used to perform volumetric change-based assessment of dynamic CA in the internal carotid artery (ICA). Dynamic CA was assessed by rate of regulation (RoR) of vascular conductance using the thigh-cuff method. Four days of beetroot supplementation increased circulating nitrate by 208 [171,245] μM (mean difference [95% confidence interval]) compared with placebo. Dynamic CA was lower in hypoxia than normoxia (RoR Δ-0.085 [-0.116, -0.054]). Compared with placebo, nitrate did not alter dynamic CA in normoxia (RoR Δ-0.022 [-0.060, 0.016]) or hypoxia (RoR Δ0.017 [-0.019, 0.053]). Further, nitrate did not affect ICA vessel diameter, blood velocity or flow in either normoxia or hypoxia. Increased bioavailability of NO through dietary nitrate supplementation did not recover the hypoxia-induced reduction in dynamic CA. This suggests the mechanism of hypoxia-induced reduction in dynamic CA does not relate to the availability of NO.",2020,"Dynamic CA was lower in hypoxia than normoxia (RoR Δ-0.085 [-0.116, -0.054]).","['Twelve healthy males (age 21\u2009±\u20092\u2009years', 'normoxia and acute hypoxia']","['dietary supplementation with a placebo or inorganic nitrate drink (140-ml beetroot juice per day) followed by 60-min of normoxia or hypoxia (fraction of inspired oxygen [FiO 2 ]\u2009=\u200913', 'Duplex ultrasonography', 'placebo', 'Dietary nitrate supplementation']","['dynamic CA in normoxia', 'Dynamic CA', 'rate of regulation (RoR) of vascular conductance', 'ICA vessel diameter, blood velocity or flow', 'dynamic cerebral autoregulation', 'circulating nitrate']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0444916', 'cui_str': 'Duplex'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0007276', 'cui_str': 'Internal carotid artery structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C1531610', 'cui_str': 'Blood velocity'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}]",12.0,0.0383355,"Dynamic CA was lower in hypoxia than normoxia (RoR Δ-0.085 [-0.116, -0.054]).","[{'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Horiuchi', 'Affiliation': 'Division of Human Environmental Science, Mt. Fuji Research Institute, Fujiyoshida, Japan.'}, {'ForeName': 'Gabriella Mk', 'Initials': 'GM', 'LastName': 'Rossetti', 'Affiliation': 'Extremes Research Group, College of Human Sciences, Bangor University, Bangor, Wales.'}, {'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'Oliver', 'Affiliation': 'Extremes Research Group, College of Human Sciences, Bangor University, Bangor, Wales.'}]",Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism,['10.1177/0271678X20910053']
2203,32530169,Application of Convolutional Neural Network in Identifying Different Levels of Isokinetic Exercise Efforts.,"Abstract


Objective To develop a convolutional neural network （CNN） that can identify isokinetic knee exercises moment of force-time diagrams under different levels of efforts. Methods The 200 healthy young volunteers performed concentric isokinetic right knee flexion-extension reciprocating exercises with maximal effort as well as half the effort at angular velocities of 30°/s and 60°/s twice, respectively, with an interval of 45 min. The moment of force-time diagrams were collected. The 200 subjects were randomly divided into the training set （140 subjects） and the testing set （60 subjects）. The moment of force-time diagrams from subjects in the training set were used to train CNN model, and then the fully trained model was used to predict types of curves from the testing set. Random sampling of subjects along with subsequent development of models were performed 3 times. Results Under the circumstances of isokinetic knee exercises with maximal effort and half the effort, 2 400 moment of force-time diagrams were produced, respectively. Classification accuracy rates of the CNN models after the 3 trainings were 91.11%, 90.49% and 92.08%, respectively, and the average accuracy rate was 91.23%. Conclusion The CNN models developed in this study have a good effect on differentiating isokinetic moment of force-time diagrams of maximal effort exercises from those made with half the effort, which can contribute to identifying levels of efforts exerted by subjects during isokinetic knee exercises.",2020,"Classification accuracy rates of the CNN models after the 3 trainings were 91.11%, 90.49% and 92.08%, respectively, and the average accuracy rate was 91.23%.","['200 subjects were randomly divided into the training set （140 subjects） and the testing set （60 subjects）', '200 healthy young volunteers']",['concentric isokinetic right knee flexion-extension reciprocating exercises'],['average accuracy rate'],"[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C4281598', 'cui_str': 'Structure of right knee region'}, {'cui': 'C0444509', 'cui_str': 'Flexion/extension'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}]",200.0,0.0143402,"Classification accuracy rates of the CNN models after the 3 trainings were 91.11%, 90.49% and 92.08%, respectively, and the average accuracy rate was 91.23%.","[{'ForeName': 'S W', 'Initials': 'SW', 'LastName': 'Chen', 'Affiliation': 'Department of Forensic Medicine, School of Basic Medical Sciences, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'D N', 'Initials': 'DN', 'LastName': 'Cui', 'Affiliation': 'Institutes of Biomedical Sciences, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Xia', 'Affiliation': 'Shanghai Key Laboratory of Forensic Medicine, Key Laboratory of Forensic Science, Ministry of Justice, Shanghai Forensic Service Platform, Academy of Forensic Science, Shanghai 200063, China.'}, {'ForeName': 'W T', 'Initials': 'WT', 'LastName': 'Xia', 'Affiliation': 'Shanghai Key Laboratory of Forensic Medicine, Key Laboratory of Forensic Science, Ministry of Justice, Shanghai Forensic Service Platform, Academy of Forensic Science, Shanghai 200063, China.'}, {'ForeName': 'J Q', 'Initials': 'JQ', 'LastName': 'Jiang', 'Affiliation': 'Department of Forensic Medicine, School of Basic Medical Sciences, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Y W', 'Initials': 'YW', 'LastName': 'Shen', 'Affiliation': 'Department of Forensic Medicine, School of Basic Medical Sciences, Fudan University, Shanghai 200032, China.'}]",Fa yi xue za zhi,['10.12116/j.issn.1004-5619.2020.02.012']
2204,32530172,Application of Eye Tracker in Lie Detection.,"Abstract


Objective To investigate the application value of eye tracking in lie detection. Methods The 40 subjects were randomly divided into two groups. The pupil diameter, fixation duration, points of fixation and blink frequency of the subjects in the experimental group in observing target stimulation and non-target stimulation were recorded with eye tracker after they accomplished the mock crime. The eye movement parameters of subjects in the control group were directly collected. The differences in eye movement parameters of the experimental group and the control group in observing target stimulation and non-target stimulation were analyzed by t-test. Pearson coefficient analysis of correlation between eye movement parameters that had differences was conducted. The effectiveness of eye movement parameters to distinguish between the experimental group and the control group was calculated by the receiver operator characteristic （ROC） curve. Results Participants from the experimental group had shorter average pupil diameter, longer average fixation duration and fewer fixation points （ P <0.05）, but the differences in blink frequency had no statistical significance. The differences in the above indicators of the control group in observing target stimulation and non-target stimulation had no statistical significance. The average fixation duration showed a negative correlation with fixation points （ r =-0.255,  P <0.05）; the average fixation duration showed a negative correlation with average pupil diameter （ r =-0.218,  P <0.05）; the fixation points showed a positive correlation with average pupil diameter （ r =0.09,  P <0.05）. The area under the curve of average pupil diameter, average fixation duration and fixation points was 0.603, 0.621 and 0.580, respectively. Conclusion The average pupil diameter, average fixation duration and fixation points obtained by the eye tracker under laboratory conditions can be used to detect lies.",2020,The differences in the above indicators of the control group in observing target stimulation and non-target stimulation had no statistical significance.,['40 subjects'],[],"['area under the curve of average pupil diameter, average fixation duration and fixation points', 'shorter average pupil diameter, longer average fixation duration', 'average pupil diameter, average fixation duration and fixation points', 'pupil diameter, fixation duration, points of fixation and blink frequency', 'average fixation duration', 'observing target stimulation and non-target stimulation']",[],[],"[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0005757', 'cui_str': 'Blinking'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]",40.0,0.0194763,The differences in the above indicators of the control group in observing target stimulation and non-target stimulation had no statistical significance.,"[{'ForeName': 'F F', 'Initials': 'FF', 'LastName': 'Ge', 'Affiliation': 'West China School of Basic Medical Sciences & Forensic Medicine, Sichuan University, Chengdu 610000, China.'}, {'ForeName': 'X Q', 'Initials': 'XQ', 'LastName': 'Yang', 'Affiliation': 'School of Life Science and Technology, University of Electronic Science and Technology of China, Chengdu 610000, China.'}, {'ForeName': 'Y X', 'Initials': 'YX', 'LastName': 'Chen', 'Affiliation': 'West China School of Basic Medical Sciences & Forensic Medicine, Sichuan University, Chengdu 610000, China.'}, {'ForeName': 'H L', 'Initials': 'HL', 'LastName': 'Huang', 'Affiliation': 'West China School of Basic Medical Sciences & Forensic Medicine, Sichuan University, Chengdu 610000, China.'}, {'ForeName': 'X C', 'Initials': 'XC', 'LastName': 'Shen', 'Affiliation': 'West China School of Basic Medical Sciences & Forensic Medicine, Sichuan University, Chengdu 610000, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'West China School of Basic Medical Sciences & Forensic Medicine, Sichuan University, Chengdu 610000, China.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Hu', 'Affiliation': 'West China School of Basic Medical Sciences & Forensic Medicine, Sichuan University, Chengdu 610000, China.'}]",Fa yi xue za zhi,['10.12116/j.issn.1004-5619.2020.02.015']
2205,31813317,Comparing face-to-face and videoconference completion of the Montreal Cognitive Assessment (MoCA) in community-based survivors of stroke.,"INTRODUCTION


Videoconferencing may help address barriers associated with poor access to post-stroke cognitive screening. However, the equivalence of videoconference and face-to-face administrations of appropriate cognitive screening tools needs to be established. We compared face-to-face and videoconference administrations of the Montreal Cognitive Assessment (MoCA) in community-based survivors of stroke. We also evaluated whether participant characteristics (e.g. age) influenced equivalence.
METHODS


We used a randomised crossover design (two-week interval). Participants were recruited through community advertising and use of a stroke-specific database. Both sessions were conducted by the same researcher in the same location. Videoconference sessions were conducted using Zoom. A repeated-measures  t- test, intraclass correlation coefficient (ICC), Bland-Altman plot and multivariate regression modelling were used to establish equivalence.
RESULTS


Forty-eight participants (26 men,  M age  = 64.6 years, standard deviation ( SD ) = 10.1;  M time since stroke  = 5.2 years,  SD  = 4.0) completed the MoCA face-to-face and via videoconference on average 15.8 ( SD  = 9.7) days apart. Participants did not perform systematically better in a particular condition, and no participant variable predicted difference in MoCA performance. However, the ICC was low (0.615), and the Bland-Altman plot indicated wide limits of agreement, indicating variability between sessions.
DISCUSSION


Our findings provide preliminary evidence to support the use of videoconference to administer the MoCA following stroke. However, further research into the test-retest reliability of scores derived from the MoCA is needed in this population. Administering the MoCA via videoconference holds potential to ensure that all stroke survivors undergo cognitive screening, in line with recommended clinical practice.",2019,"Participants did not perform systematically better in a particular condition, and no participant variable predicted difference in MoCA performance.","['Forty-eight participants (26 men,  M age \u2009=\u200964.6 years, standard deviation ( SD )\u2009=\u200910.1;  M time since stroke \u2009=\u20095.2 years,  SD \u2009=\u20094.0) completed the MoCA face-to-face and via videoconference on average 15.8 ( SD \u2009=\u20099.7) days apart', 'community-based survivors of stroke', 'Participants were recruited through community advertising and use of a stroke-specific database']","['MoCA via videoconference', 'videoconference administrations of the Montreal Cognitive Assessment (MoCA', 'Montreal Cognitive Assessment (MoCA', 'Videoconference sessions', 'videoconference']",['MoCA performance'],"[{'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C4517790', 'cui_str': '5.2'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C5191316', 'cui_str': '15.8'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0001690', 'cui_str': 'Advertising as Topic'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]","[{'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}]",48.0,0.0333148,"Participants did not perform systematically better in a particular condition, and no participant variable predicted difference in MoCA performance.","[{'ForeName': 'Jodie E', 'Initials': 'JE', 'LastName': 'Chapman', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Australia.'}, {'ForeName': 'Dominique A', 'Initials': 'DA', 'LastName': 'Cadilhac', 'Affiliation': 'Stroke & Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Australia.'}, {'ForeName': 'Betina', 'Initials': 'B', 'LastName': 'Gardner', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Australia.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Ponsford', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Australia.'}, {'ForeName': 'Ruchi', 'Initials': 'R', 'LastName': 'Bhalla', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Australia.'}, {'ForeName': 'Renerus J', 'Initials': 'RJ', 'LastName': 'Stolwyk', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Australia.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19890788']
2206,32525882,"Improved treatment of community-acquired pneumonia through tailored interventions: Results from a controlled, multicentre quality improvement project.","BACKGROUND


Community-acquired pneumonia (CAP) is one of the leading causes of healthcare utilisation and death worldwide. Treatment according to evidence-based clinical guidelines can reduce mortality, antibiotic exposure and length of hospital stay related to CAP.
LOCAL PROBLEM


Several studies, including a pilot study from one of our sites, indicate that physicians show a low grade of guideline adherence when managing patients with CAP.
METHODS


To improve the guideline-based treatment of patients with CAP admitted to hospital, we designed a quality improvement study. Four process indicators were combined in a CAP care bundle: chest X-ray, CURB-65 severity score, lower respiratory tract samples and antibiotics within 8 hours from admission. After a 4-month baseline period, we applied multiple interventions at three hospitals during 8 months. Progression in our process indicators was measured continuously and compared with a control site without interventions. After the 8-month intervention period, we continued with a 4-month follow-up period to assess the sustainability of the improvements.
RESULTS


The care bundle utilisation rate within 8 hours increased from 11% at baseline to 41% in the follow-up period at the intervention sites, whereas it remained below 3% at the control site. The most considerable improvements have been observed regarding documentation of CURB-65 (34% at baseline, 68% at follow-up) and the collection of lower respiratory tract samples (43% at baseline, 63% at follow-up).
CONCLUSION


Our study has demonstrated poor adherence to CAP guidelines at all sites at baseline. After implementing multiple tailored interventions, guideline adherence increased substantially. In conclusion, we recommend that CAP guidelines should be actively adapted in order to be followed in a daily routine.",2020,"The care bundle utilisation rate within 8 hours increased from 11% at baseline to 41% in the follow-up period at the intervention sites, whereas it remained below 3% at the control site.","['patients with CAP admitted to hospital', 'patients with CAP']",[],"['care bundle utilisation rate', 'mortality, antibiotic exposure and length of hospital stay related to CAP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",[],"[{'cui': 'C3658308', 'cui_str': 'Care Bundles'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}]",,0.02297,"The care bundle utilisation rate within 8 hours increased from 11% at baseline to 41% in the follow-up period at the intervention sites, whereas it remained below 3% at the control site.","[{'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Fally', 'Affiliation': 'Department of Internal Medicine, Section for Pulmonary Diseases, Herlev Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'von Plessen', 'Affiliation': 'Unisanté, Lausanne, Switzerland.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Anhøj', 'Affiliation': 'Centre of Diagnostic Investigation, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Benfield', 'Affiliation': 'Department of Infectious Diseases, Amager Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Tarp', 'Affiliation': 'Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Lise Notander', 'Initials': 'LN', 'LastName': 'Clausen', 'Affiliation': 'Department of Respiratory and Infectious Diseases, Nordsjaellands Hospital, Hillerød, Denmark.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Kolte', 'Affiliation': 'Department of Respiratory and Infectious Diseases, Nordsjaellands Hospital, Hillerød, Denmark.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Diernaes', 'Affiliation': 'Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Molzen', 'Affiliation': 'Department of Respiratory and Infectious Diseases, Nordsjaellands Hospital, Hillerød, Denmark.'}, {'ForeName': 'Regitze', 'Initials': 'R', 'LastName': 'Seerup', 'Affiliation': 'Department of Infectious Diseases, Amager Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Israelsen', 'Affiliation': 'Department of Infectious Diseases, Amager Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Anne-Marie Blok', 'Initials': 'AB', 'LastName': 'Hellesøe', 'Affiliation': 'Centre of Diagnostic Investigation, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Ravn', 'Affiliation': 'Department of Internal Medicine, Section for Infectious Diseases, Herlev Gentofte Hospital, Hellerup, Denmark.'}]",PloS one,['10.1371/journal.pone.0234308']
2207,32525946,Motion sickness symptoms during jumping exercise on a short-arm centrifuge.,"Artificial gravity elicited through short-arm human centrifugation combined with physical exercise, such as jumping, is promising in maintaining health and performance during space travel. However, motion sickness symptoms could limit the tolerability of the approach. Therefore, we determined the feasibility and tolerability, particularly occurrence of motion sickness symptoms, during reactive jumping exercises on a short-arm centrifuge. In 15 healthy men, we assessed motion sickness induced by jumping exercises during short-arm centrifugation at constant +1Gz or randomized variable +0.5, +0.75, +1, +1.25 and +1.5 Gz along the body axis referenced to center of mass. Jumping in the upright position served as control intervention. Test sessions were conducted on separate days in a randomized and cross-over fashion. All participants tolerated jumping exercises against terrestrial gravity and on the short-arm centrifuge during 1 Gz or variable Gz at the center of mass without disabling motion sickness symptoms. While head movements markedly differed, motion sickness scores were only modestly increased with jumping on the short-arm centrifuge compared with vertical jumps. Our study demonstrates that repetitive jumping exercises are feasible and tolerable during short-arm centrifugation. Since jumping exercises maintain muscle and bone mass, our study enables further development of exercise countermeasures in artificial gravity.",2020,"While head movements markedly differed, motion sickness scores were only modestly increased with jumping on the short-arm centrifuge compared with vertical jumps.",['15 healthy men'],"['repetitive jumping exercises', 'Artificial gravity elicited through short-arm human centrifugation combined with physical exercise']","['feasibility and tolerability, particularly occurrence of motion sickness symptoms', 'motion sickness scores', 'Motion sickness symptoms']","[{'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242678', 'cui_str': 'Gravity, Artificial'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0426857', 'cui_str': 'Short arm'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0007703', 'cui_str': 'Centrifugation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0026603', 'cui_str': 'Motion sickness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",15.0,0.0370295,"While head movements markedly differed, motion sickness scores were only modestly increased with jumping on the short-arm centrifuge compared with vertical jumps.","[{'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Frett', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center, Cologne, Germany.'}, {'ForeName': 'David Andrew', 'Initials': 'DA', 'LastName': 'Green', 'Affiliation': 'Space Medicine Team (HRE-OM), European Astronaut Centre, European Space Agency, Cologne, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Arz', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center, Cologne, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Noppe', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center, Cologne, Germany.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Petrat', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center, Cologne, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kramer', 'Affiliation': 'Institute for Sport Sciences, University Konstanz, Konstanz, Germany.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Kuemmel', 'Affiliation': 'Institute for Sport Sciences, University Konstanz, Konstanz, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Tegtbur', 'Affiliation': 'Institutes of Sports Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Jordan', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center, Cologne, Germany.'}]",PloS one,['10.1371/journal.pone.0234361']
2208,32525954,Gut carriage of antimicrobial resistance genes in women exposed to small-scale poultry farms in rural Uganda: A feasibility study.,"BACKGROUND


Antibiotic use for livestock is presumed to be a contributor to the acquisition of antimicrobial resistance (AMR) genes in humans, yet studies do not capture AMR data before and after livestock introduction.
METHODS


We performed a feasibility study by recruiting a subset of women in a delayed-start randomized controlled trial of small-scale chicken farming to examine the prevalence of clinically-relevant AMR genes. Stool samples were obtained at baseline and one year post-randomization from five intervention women who received chickens at the start of the study, six control women who did not receive chickens until the end of the study, and from chickens provided to the control group at the end of the study. Stool was screened for 87 clinically significant AMR genes using a commercially available qPCR array (Qiagen).
RESULTS


Chickens harbored 23 AMR genes from classes found in humans as well as additional vancomycin and β-lactamase resistance genes. AMR patterns between intervention and control women appeared more similar at baseline than one year post randomization (PERMANOVA R2 = 0.081, p = 0.61 at baseline, R2 = 0.186, p = 0.09 at 12 months) Women in the control group who had direct contact with the chickens sampled in the study had greater similarities in AMR gene patterns to chickens than those in the intervention group who did not have direct contact with chickens sampled (p = 0.01). However, at one year there was a trend towards increased similarity in AMR patterns between humans in both groups and the chickens sampled (p = 0.06).
CONCLUSIONS


Studies designed to evaluate human AMR genes in the setting of animal exposure should account for high baseline AMR rates. Concomitant collection of animal, human, and environmental samples over time is recommended to determine the directionality and source of AMR genes.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier NCT02619227.",2020,"AMR patterns between intervention and control women appeared more similar at baseline than one year post randomization (PERMANOVA R2 = 0.081, p = 0.61 at baseline, R2 = 0.186, p = 0.09 at 12 months)",['women exposed to small-scale poultry farms in rural Uganda'],[],"['similarity in AMR patterns', 'AMR patterns', 'AMR gene patterns']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032850', 'cui_str': 'Fowls, Domestic'}, {'cui': 'C0557759', 'cui_str': 'Farming environment'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]",[],"[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0017337', 'cui_str': 'Gene'}]",87.0,0.104382,"AMR patterns between intervention and control women appeared more similar at baseline than one year post randomization (PERMANOVA R2 = 0.081, p = 0.61 at baseline, R2 = 0.186, p = 0.09 at 12 months)","[{'ForeName': 'Ana A', 'Initials': 'AA', 'LastName': 'Weil', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital Boston, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Meti D', 'Initials': 'MD', 'LastName': 'Debela', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital Boston, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Muyanja', 'Affiliation': 'Mbarara University of Science and Technology, Mbarara, Uganda.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Kakuhikire', 'Affiliation': 'Mbarara University of Science and Technology, Mbarara, Uganda.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Baguma', 'Affiliation': 'Mbarara University of Science and Technology, Mbarara, Uganda.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Bangsberg', 'Affiliation': 'Mbarara University of Science and Technology, Mbarara, Uganda.'}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Tsai', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Peggy S', 'Initials': 'PS', 'LastName': 'Lai', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital Boston, Boston, Massachusetts, United States of America.'}]",PloS one,['10.1371/journal.pone.0229699']
2209,32541380,5-Hydroxytryptophan as adjuvant therapy in treatment of moderate to severe obsessive-compulsive disorder: a double-blind randomized trial with placebo control.,"On the basis of numerous previous studies, the serotonergic system plays a role in the pathogenesis of obsessive-compulsive disorder (OCD) and effective agents in this pathway, such as 5-hydroxytryptophan, can potentially contribute to treatment of patients with this disorder. Evaluating the efficacy of 5-hydroxytryptophan in treating OCD was the aim of the present randomized, double-blind, placebo-controlled 12-week trial. In a 12-week, randomized double-blind study, 60 patients with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition diagnosis of moderate to severe OCD and a Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score of >21 were randomly assigned to receive either fluoxetine plus placebo or fluoxetine plus 5-hydroxytryptophan (100 mg twice daily). All patients, regardless of their treatment group, received fluoxetine at 20 mg/day for the initial 4 weeks of the study followed by 60 mg/day of fluoxetine for the rest of the trial course. Symptoms were assessed using the Y-BOCS at baseline and weeks 4, 8 and 12. General linear model repeated measure showed significant effects for time × treatment interaction on total Y-BOCS (F = 12.07, df = 2.29, P-value <0.001), obsession (F = 8.25, df = 1.91, P-value = 0.001) and compulsion subscale scores (F = 6.64, df = 2.01, P-value = 0.002). 5-Hydroxytryptophan augmentation therapy demonstrated higher partial and complete treatment response rate (P = 0.032 and P = 0.001, respectively) according to the Y-BOCS total scores. The results of this study confirm that 5-hydroxytryptophan may be effective as an augmentative agent in treatment of moderate-to-severe OCD.",2020,"5-Hydroxytryptophan augmentation therapy demonstrated higher partial and complete treatment response rate (P = 0.032 and P = 0.001, respectively) according to the Y-BOCS total scores.","['moderate to severe obsessive-compulsive disorder', '60 patients with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition diagnosis of moderate to severe OCD and a Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score of >21', 'patients with this disorder']","['5-Hydroxytryptophan', '5-hydroxytryptophan', 'fluoxetine', 'fluoxetine plus placebo or fluoxetine plus 5-hydroxytryptophan', '5-Hydroxytryptophan augmentation therapy', 'placebo']","['compulsion subscale scores', 'total Y-BOCS', 'higher partial and complete treatment response rate']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0000578', 'cui_str': '5-Hydroxytryptophan'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0600104', 'cui_str': 'Compulsive behavior'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",60.0,0.0988532,"5-Hydroxytryptophan augmentation therapy demonstrated higher partial and complete treatment response rate (P = 0.032 and P = 0.001, respectively) according to the Y-BOCS total scores.","[{'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Yousefzadeh', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital.'}, {'ForeName': 'Erfan', 'Initials': 'E', 'LastName': 'Sahebolzamani', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Sadri', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital.'}, {'ForeName': 'Amirhosein', 'Initials': 'A', 'LastName': 'Mortezaei', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Aqamolaei', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital.'}, {'ForeName': 'Seyyed Hosein', 'Initials': 'SH', 'LastName': 'Mortazavi', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital.'}, {'ForeName': 'Mohammd Reza', 'Initials': 'MR', 'LastName': 'Shalbafan', 'Affiliation': 'Mental Health Research Center, Iran University of Medical Sciences.'}, {'ForeName': 'Salomeh', 'Initials': 'S', 'LastName': 'Ghaffari', 'Affiliation': 'School of Persian Medicine, Iran University of Medical Sciences, Research Institute for Islamic and Complementory Medicine.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Alikhani', 'Affiliation': 'Psychosis Research Center, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Seiedeh Bentolhoda', 'Initials': 'SB', 'LastName': 'Mousavi', 'Affiliation': 'Psychosis Research Center, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Naderi', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Shamabadi', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital.'}, {'ForeName': 'Shakiba', 'Initials': 'S', 'LastName': 'Jalilevand', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Akhondzadeh', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital.'}]",International clinical psychopharmacology,['10.1097/YIC.0000000000000321']
2210,32541398,Clinical Demonstration of the Potential of Parental Feedback in Reducing Deterioration During Group Psychotherapy With Children.,"In recent years, great efforts have been exerted to minimize the rates of deterioration in clinical practice, especially in child psychotherapy. The present study explored the potential effect of routine outcome monitoring (ROM) with parents as a preventive intervention to reduce deterioration in children. Twenty-five children receiving treatment for emotional problems were randomized to parent-based, ROM-assisted group psychotherapy or to treatment as usual (TAU). A mixed-methods approach was utilized, with the number of deteriorating cases compared at the group level and two case illustrations assessed at the individual level. At the group level, there were fewer cases of deterioration in child's anxiety, parental stress, and quality of parent's alliance in the ROM-assisted group, compared with TAU. Case studies illustrated how ROM can be used as a tool to communicate with parents to prevent deterioration. Routine outcome monitoring in child psychotherapy may thus benefit therapy process and outcome. Limitations and directions for future research are discussed.",2020,"At the group level, there were fewer cases of deterioration in child's anxiety, parental stress, and quality of parent's alliance in the ROM-assisted group, compared with TAU.","['Twenty-five children receiving treatment for emotional problems', 'children']","['routine outcome monitoring (ROM', 'ROM-assisted group psychotherapy or to treatment as usual (TAU']","[""deterioration in child's anxiety, parental stress, and quality of parent's alliance"", 'Deterioration']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0677660', 'cui_str': 'Emotional problems'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1999012', 'cui_str': 'Parental role conflict'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]",25.0,0.0301144,"At the group level, there were fewer cases of deterioration in child's anxiety, parental stress, and quality of parent's alliance in the ROM-assisted group, compared with TAU.","[{'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Tzur Bitan', 'Affiliation': 'Department of Behavioral Sciences, Ariel University, Ariel.'}, {'ForeName': 'Sigal', 'Initials': 'S', 'LastName': 'Zilcha-Mano', 'Affiliation': 'Department of Psychology, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Asper', 'Affiliation': 'Department of Behavioral Sciences, Ariel University, Ariel.'}, {'ForeName': 'Yuval', 'Initials': 'Y', 'LastName': 'Bloch', 'Affiliation': 'Shalvata Mental Health Center, Hod HaSharon, affiliated with the Sackler School of Medicine, Tel Aviv University, Ramat Aviv.'}]",The Journal of nervous and mental disease,['10.1097/NMD.0000000000001199']
2211,32541462,Analgesic impact of buprenorphine transdermal patch in total hip arthroplasty: A randomized controlled trial protocol.,"BACKGROUND


The efficacy and safety of buprenorphine transdermal patch (BTP) has been well established in chronic pain, but data regarding acute postoperative pain relief is still very limited. Therefore, we design a prospective, randomized, controlled study to evaluate the effectiveness and safety of the BTP for postoperative analgesia in total hip arthroplasty.
METHODS


This study is designed as a single-center, prospective, double-blind, randomized controlled trial. Group A receives a 10 mg patch of buprenorphine at the conclusion of surgery which is continued for 14 days. Group B receives a conventional analgesic regimen, that is, IV paracetamol 1 mg every 8 hours alternating with parenteral tramadol 50 mg every 8 hours for the first 2 postoperative days followed by oral administration of the same drug still the end of 2 weeks. A total of 160 patients are needed with an allowance for 10% drop-out. The primary outcome of this noninferiority study is opioid consumption within the first 24 hours following surgery. The secondary outcomes included numerical rating scale scores at rest, postoperative complications, length of hospital stay, and patient satisfaction.
RESULTS


This trial is expected to be the largest randomized trial assessing the efficacy of BTP after primary total hip arthroplasty and powered to detect a potential difference in the primary outcome.
TRIAL REGISTRATION NUMBER


This study protocol was registered in Research Registry (researchregistry5524).",2020,"BACKGROUND


The efficacy and safety of buprenorphine transdermal patch (BTP) has been well established in chronic pain, but data regarding acute postoperative pain relief is still very limited.","['160 patients are needed with an allowance for 10% drop-out', 'total hip arthroplasty']","['buprenorphine transdermal patch (BTP', 'buprenorphine transdermal patch', 'buprenorphine', 'BTP']","['opioid consumption within the first 24\u200ahours following surgery', 'numerical rating scale scores at rest, postoperative complications, length of hospital stay, and patient satisfaction', 'Analgesic impact']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0991556', 'cui_str': 'Prolonged-release transdermal patch'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]",160.0,0.340723,"BACKGROUND


The efficacy and safety of buprenorphine transdermal patch (BTP) has been well established in chronic pain, but data regarding acute postoperative pain relief is still very limited.","[{'ForeName': 'Wen-Min', 'Initials': 'WM', 'LastName': 'Li', 'Affiliation': 'Department of Medicine, Linyi Cancer Hospital.'}, {'ForeName': 'Feng-Dao', 'Initials': 'FD', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Yinan County Hospital of Traditional Chinese Medicine.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopedics, Linyi Cancer Hospital, Shandong, China.'}, {'ForeName': 'Li-Chen', 'Initials': 'LC', 'LastName': 'Sun', 'Affiliation': 'Department of Medicine, Linyi Cancer Hospital.'}]",Medicine,['10.1097/MD.0000000000020405']
2212,32541473,Corticosteroids or immunosuppressants were not superior to supportive care in IgA nephropathy patients with mild proteinuria.,"BACKGROUND


We aimed to evaluate the effect of immunosuppressant therapy for immunoglobulin A nephropathy (IgAN) patients with mild proteinuria (<1 g/d).
METHODS


We recruited patients with biopsy-proven IgAN from 4 study centers. Patients were followed for more than 1 year or up to the study end point. Clinical indexes, renal pathological data, and treatment information were collected during the follow-up period. IgAN patients with mild proteinuria (<1 g/d at biopsy) were included. Patients were divided into a supportive care group (SC) and an immunosuppressant group (IT). Patients in the SC group received the optimal dose of renin angiotensin system inhibitors (RASi). Patients in the IT group received corticosteroids or immunosuppressant therapy plus RASi. Responses to therapy included complete remission (CR), partial remission (PR), no response (NR), and end stage renal disease (ESRD). A 50% decline in estimated glomerular filtration rate (eGFR) and/or ESRD was the primary end point of this study.
RESULTS


295 patients (36.3% male and 63.7% female) were included in this study and were followed for 49.46 ± 24.35 months. We found a significant difference in estimated glomerular filtration rate, urine protein, mesangial hypercellularity, segmental glomerulosclerosis, cellular or fibrocellular crescents, and glomerulosclerosis between the 2 treatment groups at baseline. At the final follow-up, 224 patients (75.9%) achieved CR, 7 patients (2.4%) achieved PR, 55 patients (18.6%) had NR, and 9 patients (3.1%) reached ESRD. However, no significant differences were observed between the SC and IT groups with respect to CR (76.4% vs 73.5%, P = .659), PR (2.0% vs 4.1%, P = .329), NR (18.3% vs 20.4%, P = .728), and ESRD (3.3% vs 2.0%, P = 1.000). Kidney survival rates were also comparable between the SC and IT groups (93.7% vs 94.1%, P = .808). We observed similar results after subgroup analysis according to chronic kidney disease stages or pathological manifestations. A multivariate model showed that segmental sclerosis (HR 9.55, 95% CI 1.04-88.16, P = .047) and glomerulosclerosis (HR 21.09, 95% CI 1.39-320.53, P = .028) were independent predictors of poor renal survival.
CONCLUSIONS


Corticosteroids or immunosuppressants were not superior to supportive care in IgA nephropathy patients with mild proteinuria.",2020,"We found a significant difference in estimated glomerular filtration rate, urine protein, mesangial hypercellularity, segmental glomerulosclerosis, cellular or fibrocellular crescents, and glomerulosclerosis between the 2 treatment groups at baseline.","['295 patients (36.3% male and 63.7% female', 'immunoglobulin A nephropathy (IgAN) patients with mild proteinuria (<1\u200ag/d', 'patients with biopsy-proven IgAN from 4 study centers', 'IgA nephropathy patients with mild proteinuria', 'IgAN patients with mild proteinuria (<1\u200ag/d at biopsy']","['corticosteroids or immunosuppressant therapy plus RASi', 'supportive care group (SC', 'Corticosteroids or immunosuppressants', 'immunosuppressant group (IT', 'immunosuppressant therapy', 'renin angiotensin system inhibitors (RASi']","['complete remission (CR), partial remission (PR), no response (NR), and end stage renal disease (ESRD', 'Clinical indexes, renal pathological data, and treatment information', 'Kidney survival rates', 'ESRD', 'PR', 'estimated glomerular filtration rate (eGFR', 'segmental sclerosis', 'glomerulosclerosis', 'estimated glomerular filtration rate, urine protein, mesangial hypercellularity, segmental glomerulosclerosis, cellular or fibrocellular crescents, and glomerulosclerosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0017661', 'cui_str': 'IgA nephropathy'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0205122', 'cui_str': 'Segmental'}, {'cui': 'C0036429', 'cui_str': 'Sclerosis'}, {'cui': 'C0178664', 'cui_str': 'Glomerulosclerosis'}, {'cui': 'C0262923', 'cui_str': 'Urine protein test'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}, {'cui': 'C0333497', 'cui_str': 'Segmental glomerulosclerosis'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0444628', 'cui_str': 'Crescents'}]",295.0,0.0596618,"We found a significant difference in estimated glomerular filtration rate, urine protein, mesangial hypercellularity, segmental glomerulosclerosis, cellular or fibrocellular crescents, and glomerulosclerosis between the 2 treatment groups at baseline.","[{'ForeName': 'Gaiqin', 'Initials': 'G', 'LastName': 'Pei', 'Affiliation': 'Division of Nephrology, Department of Medicine, West China Hospital.'}, {'ForeName': 'Jiaxing', 'Initials': 'J', 'LastName': 'Tan', 'Affiliation': 'Division of Nephrology, Department of Medicine, West China Hospital.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Division of Nephrology, Department of Medicine, West China Hospital.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Tan', 'Affiliation': 'West China School of Medicine, Sichuan University, Chengdu, Sichuan.'}, {'ForeName': 'Zhengxia', 'Initials': 'Z', 'LastName': 'Zhong', 'Affiliation': 'Affiliated Hospital of Zunyi Medical College, Zunyi, Guizhou.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'The Third Hospital of Zigong City, Zigong, Sichuan.'}, {'ForeName': 'Changyun', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': ""People's Hospital of Mianzu, Mianzu, Sichuan, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Qin', 'Affiliation': 'Division of Nephrology, Department of Medicine, West China Hospital.'}]",Medicine,['10.1097/MD.0000000000020513']
2213,32541528,Dose-response of rPMS for upper Limb hemiparesis after stroke.,"INTRODUCTION


Repetitive peripheral magnetic stimulation (rPMS) therapy is an innovative and minimally invasive neurorehabilitative technique and has been shown to facilitate neural plasticity. However, there is at present no research that clarifies the dose-response of rPMS therapy on the recovery of upper limb hemiparesis after stroke. This trial aims to clarify the dose-response of rPMS therapy combined with intensive occupational therapy (OT) for chronic stroke patients with moderate to severe upper limb hemiparesis.
METHODS AND ANALYSIS


This multicenter, prospective, assessor-blinded, randomized controlled study with 3 parallel groups will be conducted from January 20, 2020 to September 30, 2022. Fifty patients will be randomly assigned in a ratio of 1:2:2 to the control group, the group receiving daily 2400 pulses of rPMS, or the group receiving daily 4800 pulses of rPMS, respectively. From the day after admission (Day 1), rPMS therapy and intensive OT will be initiated. The primary outcome is the change in the motor function of the affected upper extremity (Fugl-Meyer Assessment) between the time of admission (Day 0) and the day after 2 weeks of treatment (Day 14). Secondary outcomes will include the changes in spasticity, active range of motion, motor evoked potential, and activity of daily living.
ETHICS AND DISSEMINATION


The study was approved by the Jikei University Certified Review Board for all institutions (reference number: JKI19-020). Results of the primary and secondary outcomes will be published in a peer-reviewed journal and presented at international congresses. The results will also be disseminated to patients.
TRIAL REGISTRATION NUMBER


jRCTs032190191.",2020,"Secondary outcomes will include the changes in spasticity, active range of motion, motor evoked potential, and activity of daily living.
","['chronic stroke patients with moderate to severe upper limb hemiparesis', '3 parallel groups will be conducted from January 20, 2020 to September 30, 2022', 'Fifty patients']","['rPMS therapy combined with intensive occupational therapy (OT', 'rPMS therapy', 'Repetitive peripheral magnetic stimulation (rPMS) therapy', 'rPMS', 'group receiving daily 2400 pulses of rPMS, or the group receiving daily 4800 pulses of rPMS']","['changes in spasticity, active range of motion, motor evoked potential, and activity of daily living', 'change in the motor function of the affected upper extremity (Fugl-Meyer Assessment']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0018989', 'cui_str': 'Hemiparesis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C2350609', 'cui_str': 'Magnetic Stimulation Therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4517656', 'cui_str': '2400'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",50.0,0.185728,"Secondary outcomes will include the changes in spasticity, active range of motion, motor evoked potential, and activity of daily living.
","[{'ForeName': 'Shoji', 'Initials': 'S', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Rehabilitation Medicine.'}, {'ForeName': 'Kumi', 'Initials': 'K', 'LastName': 'Ikeda', 'Affiliation': 'Department of Rehabilitation Medicine.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Yasuno', 'Affiliation': 'Clinical Research Support Center, The Jikei University School of Medicine, Minato-Ku, Tokyo, Japan.'}, {'ForeName': 'Sho', 'Initials': 'S', 'LastName': 'Takahashi', 'Affiliation': 'Clinical Research Support Center, The Jikei University School of Medicine, Minato-Ku, Tokyo, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Yamada', 'Affiliation': 'Department of Rehabilitation Medicine.'}, {'ForeName': 'Yumi', 'Initials': 'Y', 'LastName': 'Okuyama', 'Affiliation': 'Department of Rehabilitation Medicine.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Sasaki', 'Affiliation': 'Department of Rehabilitation Medicine.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Hada', 'Affiliation': 'Department of Rehabilitation Medicine.'}, {'ForeName': 'Chiaki', 'Initials': 'C', 'LastName': 'Kuriyama', 'Affiliation': 'Department of Rehabilitation Medicine.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Suzuki', 'Affiliation': 'Department of Rehabilitation Medicine.'}, {'ForeName': 'Midori', 'Initials': 'M', 'LastName': 'Hama', 'Affiliation': 'Department of Rehabilitation Medicine.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Ozaki', 'Affiliation': 'Department of Rehabilitation Medicine.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Watanabe', 'Affiliation': 'Department of Rehabilitation Medicine.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Abo', 'Affiliation': 'Department of Rehabilitation Medicine.'}]",Medicine,['10.1097/MD.0000000000020752']
2214,32541530,Comparison of sugammadex and pyridostigmine bromide for reversal of rocuronium-induced neuromuscular blockade in short-term pediatric surgery: A prospective randomized study: Retraction.,,2020,,['short-term pediatric surgery'],['sugammadex and pyridostigmine bromide'],[],"[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0279077', 'cui_str': 'Pediatric surgery'}]","[{'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C0034262', 'cui_str': 'Pyridostigmine bromide'}]",[],,0.0907641,,[],Medicine,['10.1097/MD.0000000000020879']
2215,32541548,The impact of an optimism training intervention on biological measures associated with cardiovascular health: data from a randomized controlled trial.,"OBJECTIVE


Positive psychological constructs, such as optimism, are associated with cardiovascular health, and changes in biological measures associated with heart health have been proposed as potential mediators of these relationships. In this analysis of data from a randomized controlled trial, we examined the impact of an optimism training intervention on biological measures associated with cardiac health in patients with coronary artery disease (CAD).
METHODS


We analyzed data from an 8-week, randomized, controlled trial of a group-based optimism training intervention in 61 patients with CAD. High sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), irisin, and fibrinogen were measured at baseline, 8 weeks, and 16 weeks. Mixed effects regression analyses were performed to examine the effects of the intervention on changes in biological measures at 8 and 16 weeks.
RESULTS


At 8 weeks, the intervention led to significantly greater reductions in hs-CRP (B=-0.851 [standard error (SE)=0.273], p=.002) and fibrinogen (B=-0.148 [SE=0.062], p=.016), and a greater increase in irisin (B=0.252 [SE=0.114], p=.027), than the control condition. These changes persisted at 16 weeks (hs-CRP: B=-1.078 [SE=0.276], p<.001; fibrinogen: B=-0.270 [SE=0.062], p<.001; irisin: B=0.525 [SE=0.116], p<.001), and IL-6 additionally was impacted at this time point (B=-0.214 [SE=0.064], p=.001). Exploratory mediation analyses failed to identify significant psychological or health behavior mediators of these relationships.
CONCLUSIONS


A group-based optimism training intervention resulted in significant, robust, and sustained changes in biological measures associated with cardiac health. Further studies are needed to confirm these findings in a larger sample and identify potential mediating variables.IRCT #2016070328769N1.",2020,"At 8 weeks, the intervention led to significantly greater reductions in hs-CRP (B=-0.851 [standard error (SE)=0.273], p=.002) and fibrinogen (B=-0.148 [SE=0.062], p=.016), and a greater increase in irisin (B=0.252 [SE=0.114], p=.027), than the control condition.","['61 patients with CAD', 'patients with coronary artery disease (CAD']","['optimism training intervention', 'IRCT']","['irisin', 'fibrinogen', 'High sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), irisin, and fibrinogen', 'hs-CRP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",61.0,0.139647,"At 8 weeks, the intervention led to significantly greater reductions in hs-CRP (B=-0.851 [standard error (SE)=0.273], p=.002) and fibrinogen (B=-0.148 [SE=0.062], p=.016), and a greater increase in irisin (B=0.252 [SE=0.114], p=.027), than the control condition.","[{'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Mohammadi', 'Affiliation': 'Psychosomatic Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Aghayousefi', 'Affiliation': 'Department of Psychology, Payame Noor University, Tehran, Iran.'}, {'ForeName': 'Gholam Reza', 'Initials': 'GR', 'LastName': 'Nikrahan', 'Affiliation': 'Department of psychology, Farhangian University, Tehran, Iran.'}, {'ForeName': 'Franklin', 'Initials': 'F', 'LastName': 'King', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Alipour', 'Affiliation': 'Department of Psychology, Payame Noor University, Tehran, Iran.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Sadeghi', 'Affiliation': 'Department of Cardiology, Cardiac Rehabilitation Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Roohafza', 'Affiliation': 'Department of Psychiatry, Isfahan Cardiovascular Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Celano', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Perla Romero', 'Initials': 'PR', 'LastName': 'Gomez', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Jeff C', 'Initials': 'JC', 'LastName': 'Huffman', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}]",Psychosomatic medicine,['10.1097/PSY.0000000000000834']
2216,32541565,Live Birth Following Uterine Transplantation From a Nulliparous Deceased Donor.,"BACKGROUND


Nulliparous uterine grafts have never been used in uterus transplantation, possibly due to presumed infertility. Our objective was to verify the feasibility of nulliparous uterine graft transplantation.
METHODS


The Czech Uterus Transplant Trial (registered under ClinicalTrials.gov, identifier NCT03277430) is a two-arm trial comparing the efficacy of deceased-donor vs. live-donor uterus transplant (10 patients in both arms). A 25-year-old patient suffering from inborn absolute uterine factor infertility underwent a deceased-donor uterus transplant. The donor was a 20-year-old nulliparous brain-dead donor.
RESULTS


The transplant procedure was uneventful. The posttransplant period was complicated by (i) recurrent episodes of acute cellular rejection, (ii) neutropenia necessitating the administration of granulocyte colony-stimulating factor, (iii) vaginal anastomotic stenosis treated with the insertion of a self-expanding stent, (iv) the concurrence of Clostridium difficile colitis and acute appendicitis, and (v) temporary renal function impairment of a combined aetiology. Two years after the uterus transplantation, after the fourth embryo transfer, the patient became pregnant. Apart from gestational diabetes mellitus, the pregnancy was uneventful. Due to preterm contractions, delivery was achieved via caesarean section at gestational age 34 + 6. The postoperative course was uneventful for both the mother and the newborn.
CONCLUSIONS


Herein, we report the first live birth after a deceased-donor uterus transplantation in Europe. This report provides a proof of concept that nulliparous uteri may present a suitable source of uterine grafts for uterus transplantation. Stenting may serve as a feasible treatment method for vaginal anastomotic stenosis.",2020,This report provides a proof of concept that nulliparous uteri may present a suitable source of uterine grafts for uterus transplantation.,"['A 25-year-old patient suffering from inborn absolute uterine factor infertility underwent a deceased-donor uterus transplant', 'nulliparous uterine graft transplantation', 'Nulliparous uterine grafts']","['Uterine Transplantation', 'deceased-donor vs. live-donor uterus transplant']","['postoperative course', 'Live Birth']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}]","[{'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}]",,0.0877675,This report provides a proof of concept that nulliparous uteri may present a suitable source of uterine grafts for uterus transplantation.,"[{'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Fronek', 'Affiliation': 'Transplant Surgery Department, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Libor', 'Initials': 'L', 'LastName': 'Janousek', 'Affiliation': 'Transplant Surgery Department, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Kristek', 'Affiliation': 'Transplant Surgery Department, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Jaroslav', 'Initials': 'J', 'LastName': 'Chlupac', 'Affiliation': 'Transplant Surgery Department, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Pluta', 'Affiliation': 'Department of Obstetrics and Gynaecology, Second Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Novotny', 'Affiliation': 'Transplant Surgery Department, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Maluskova', 'Affiliation': 'Department of Clinical and Transplant Pathology, Institute of Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Olausson', 'Affiliation': 'Department of Transplantation Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden.'}]",Transplantation,['10.1097/TP.0000000000003346']
2217,32541572,Effect of a Recombinant Human Soluble Thrombomodulin on Baseline Coagulation Biomarker Levels and Mortality Outcome in Patients With Sepsis-Associated Coagulopathy.,"OBJECTIVES


To assess the effects of recombinant human soluble thrombomodulin treatment on 28-day all-cause mortality in subgroups categorized by baseline coagulation biomarker levels (prothrombin fragment 1.2, thrombin-antithrombin complex, D-dimer) in patients with sepsis-associated coagulopathy in the Sepsis Coagulopathy Asahi Recombinant LE Thrombomodulin trial (SCARLET) (NCT01598831).
DESIGN


Post hoc, subgroup analysis of a randomized, double-blind, placebo-controlled, multinational, multicenter phase 3 study.
SETTING


ICUs at 159 sites in 26 countries.
PATIENTS


Eight-hundred adults with sepsis-associated coagulopathy defined as international normalized ratio greater than 1.40 and platelet count between 30 × 10/L and 150 × 10/L or greater than 30% decrease within 24 hours with concomitant cardiovascular and/or respiratory failure.
INTERVENTIONS


Patients randomized and treated with recombinant human soluble thrombomodulin (0.06 mg/kg/d; n = 395) or equivalent placebo (n = 405) for 6 days.
MEASUREMENTS AND MAIN RESULTS


Recombinant human soluble thrombomodulin did not significantly reduce 28-day all-cause mortality in the Sepsis Coagulopathy Asahi Recombinant LE Thrombomodulin trial: absolute risk reduction was 2.55% (p = 0.32) in patients with sepsis-associated coagulopathy. In this post hoc analysis, mortality steadily increased with increasing baseline prothrombin fragment 1.2 and thrombin-antithrombin complex levels in the placebo group; for those values exceeding the upper limit of normal, the mortality increases in the recombinant human soluble thrombomodulin group were lower or negligible with increasing baseline prothrombin fragment 1.2 and thrombin-antithrombin complex. Consequently, absolute risk reductions were greater in subgroups with higher baseline prothrombin fragment 1.2 or thrombin-antithrombin complex. Absolute risk reductions were also greater in subgroups with baseline coagulation biomarker levels at or above median of the entire study population, ranging from 4.2% (95% CI, -5.0% to 13.4%) to 5.5% (95% CI, -4.0% to 14.9%).
CONCLUSIONS


Compared with patients receiving placebo, patients treated with recombinant human soluble thrombomodulin having higher baseline thrombin generation biomarker levels had lower mortality. Further research regarding the predictive role of coagulation biomarkers for recombinant human soluble thrombomodulin treatment response in sepsis-associated coagulopathy is warranted to evaluate clinical relevance.",2020,Recombinant human soluble thrombomodulin did not significantly reduce 28-day all-cause mortality in the Sepsis Coagulopathy Asahi Recombinant LE Thrombomodulin trial: absolute risk reduction was 2.55% (p = 0.32) in patients with sepsis-associated coagulopathy.,"['patients with sepsis-associated coagulopathy in the Sepsis Coagulopathy Asahi Recombinant LE Thrombomodulin trial (SCARLET) (NCT01598831', 'Patients With Sepsis-Associated Coagulopathy', 'ICUs at 159 sites in 26 countries', 'Eight-hundred adults with sepsis-associated coagulopathy defined as international normalized ratio greater than 1.40 and platelet count between 30 × 10/L and 150 × 10/L or greater than 30% decrease within 24 hours with concomitant cardiovascular and/or respiratory failure']","['equivalent placebo', 'Recombinant Human Soluble Thrombomodulin', 'recombinant human soluble thrombomodulin', 'recombinant human soluble thrombomodulin treatment', 'Recombinant human soluble thrombomodulin', 'placebo']","['Baseline Coagulation Biomarker Levels and Mortality Outcome', 'Absolute risk reductions', 'absolute risk reductions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}]","[{'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}]",800.0,0.39019,Recombinant human soluble thrombomodulin did not significantly reduce 28-day all-cause mortality in the Sepsis Coagulopathy Asahi Recombinant LE Thrombomodulin trial: absolute risk reduction was 2.55% (p = 0.32) in patients with sepsis-associated coagulopathy.,"[{'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Levi', 'Affiliation': 'Department of Medicine and Cardiometabolic Programme - NIHR UCLH/UCL BRC, University College London Hospitals NHS Trust, London, United Kingdom.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Vincent', 'Affiliation': 'Department of Intensive Care, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Asahi Kasei Pharma America Corporation, Waltham, MA.'}, {'ForeName': 'Amanda H', 'Initials': 'AH', 'LastName': 'Radford', 'Affiliation': 'Asahi Kasei Pharma America Corporation, Waltham, MA.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Kayanoki', 'Affiliation': 'Asahi Kasei Pharma America Corporation, Waltham, MA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Fineberg', 'Affiliation': 'Asahi Kasei Pharma America Corporation, Waltham, MA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Hoppensteadt', 'Affiliation': 'Loyola University Medical Center, Maywood, IL.'}, {'ForeName': 'Jawed', 'Initials': 'J', 'LastName': 'Fareed', 'Affiliation': 'Loyola University Medical Center, Maywood, IL.'}]",Critical care medicine,['10.1097/CCM.0000000000004426']
2218,32541773,Inhaled nitric oxide therapy in acute bronchiolitis: A multicenter randomized clinical trial.,"Currently, there are no approved treatments for infants with acute bronchiolitis, the leading cause for hospitalization of infants worldwide, and thus the recommended approach is supportive. Inhaled Nitric oxide (iNO), possesses anti-viral properties, improves oxygenation, and was shown to be safe in infants with respiratory conditions. Hospitalized infants with acute bronchiolitis were therefore recruited to a prospective double-blinded, multi-center, randomized controlled pilot study. They received intermittent high dose iNO (160 ppm) plus oxygen/air for 30 min or oxygen/air alone (control), five times/day, up to 5 days. Sixty-nine infants were enrolled. No difference was observed in frequencies of subjects with at least one Adverse Event (AE) in iNO (44.1%) vs. control (55.9%); neither was Methemoglobin >7% safety threshold. No drug-related serious AEs (SAEs) were reported. Analysis of Per-Protocol population revealed that length of stay (LOS), time to SpO 2  ≥92%, and time to mTal clinical score ≤5 improved by 26.7 ± 12.7 (Welch's t-test p = 0.04), 20.8 ± 8.9 (p = 0.023), and 14.6 ± 9.1 (p = 0.118) hours, respectively, in the iNO group compared to the control. Overall, high dose iNO (160ppm) was safe, well-tolerated, reduced LOS and showed rapid improvement of oxygen saturation, compared to the standard therapy. Further investigation in larger cohorts is warranted to validate these encouraging efficacy outcomes. (Trial registration: NCT03053388).",2020,"Overall, high dose iNO (160ppm) was safe, well-tolerated, reduced LOS and showed rapid improvement of oxygen saturation, compared to the standard therapy.","['infants with acute bronchiolitis', 'Sixty-nine infants were enrolled', 'infants with respiratory conditions', 'Hospitalized infants with acute bronchiolitis', 'acute bronchiolitis']","['Inhaled nitric oxide therapy', 'Inhaled Nitric oxide (iNO', 'intermittent high dose iNO (160 ppm) plus oxygen/air for 30\u2009min or oxygen/air alone (control']","['oxygen saturation', 'safe, well-tolerated, reduced LOS', 'length of stay (LOS), time to SpO 2  ≥92%, and time to mTal clinical score']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001311', 'cui_str': 'Acute bronchiolitis'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",69.0,0.266451,"Overall, high dose iNO (160ppm) was safe, well-tolerated, reduced LOS and showed rapid improvement of oxygen saturation, compared to the standard therapy.","[{'ForeName': 'Aviv', 'Initials': 'A', 'LastName': 'Goldbart', 'Affiliation': 'Saban Pediatric Medical Center, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University, Beer Sheva, Israel. avivgold@bgu.ac.il.'}, {'ForeName': 'Inbal', 'Initials': 'I', 'LastName': 'Golan-Tripto', 'Affiliation': 'Saban Pediatric Medical Center, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University, Beer Sheva, Israel.'}, {'ForeName': 'Giora', 'Initials': 'G', 'LastName': 'Pillar', 'Affiliation': 'Carmel Medical Center, Haifa, Israel.'}, {'ForeName': 'Galit', 'Initials': 'G', 'LastName': 'Livnat-Levanon', 'Affiliation': 'Carmel Medical Center, Haifa, Israel.'}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Efrati', 'Affiliation': 'Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Ronen', 'Initials': 'R', 'LastName': 'Spiegel', 'Affiliation': 'Haemek Medical Center, Afula, Israel.'}, {'ForeName': 'Ronit', 'Initials': 'R', 'LastName': 'Lubetzky', 'Affiliation': ""Dana-Dwek Children's Hospital, Tel Aviv Sourasky Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.""}, {'ForeName': 'Moran', 'Initials': 'M', 'LastName': 'Lavie', 'Affiliation': ""Dana-Dwek Children's Hospital, Tel Aviv Sourasky Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.""}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Carmon', 'Affiliation': 'Saban Pediatric Medical Center, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University, Beer Sheva, Israel.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Nahum', 'Affiliation': 'Saban Pediatric Medical Center, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University, Beer Sheva, Israel.'}]",Scientific reports,['10.1038/s41598-020-66433-8']
2219,32541837,Anticipatory control of human gait following simulated slip exposure.,"A cautious gait (CG), marked by wider and shorter steps, is typically employed to mitigate expected perturbations proactively. However, it is not well understood if and how CG is informed by the task requirements. Therefore, we assessed how CG is adjusted to these requirements. Three groups of ten healthy young adults were exposed to a single uninterrupted protocol of treadmill walking that consisted of three distinct phases. Spatiotemporal step characteristics and margins of stability of the unperturbed strides were compared when participants were (i) only warned of a perturbation, (ii) exposed to fifty unilateral (right) slip-like perturbations and (iii) kept unaware of perturbation removal. Only the perturbation intensity predictability differed between groups. This was either kept consistent or pseudo-randomly or randomly varied. Participants walked with wider and shorter steps following the perturbation warning. However, this extinguished in continuing perturbation absence. Next, during perturbation exposure, participants shortened the step of the perturbed but increased the step of the unperturbed leg. This did not differ between groups. Finally, participants persisted in displaying CG on perturbation removal, but this extinguished over time. Collectively, we show that CG is functionally adjusted to the task requirements. These findings may have practical implications for fall-prevention training.",2020,Only the perturbation intensity predictability differed between groups.,"['participants were (i) only warned of a perturbation, (ii) exposed to fifty unilateral (right) slip-like perturbations and (iii) kept unaware of perturbation removal', 'Three groups of ten healthy young adults']",['Anticipatory control of human gait following simulated slip exposure'],['perturbation intensity predictability'],"[{'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",10.0,0.0212785,Only the perturbation intensity predictability differed between groups.,"[{'ForeName': 'Sander B', 'Initials': 'SB', 'LastName': 'Swart', 'Affiliation': 'University of Groningen, University Medical Centre Groningen, Department of Human Movement Sciences, Groningen, The Netherlands. s.b.swart@umcg.nl.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'den Otter', 'Affiliation': 'University of Groningen, University Medical Centre Groningen, Department of Human Movement Sciences, Groningen, The Netherlands.'}, {'ForeName': 'Claudine J C', 'Initials': 'CJC', 'LastName': 'Lamoth', 'Affiliation': 'University of Groningen, University Medical Centre Groningen, Department of Human Movement Sciences, Groningen, The Netherlands.'}]",Scientific reports,['10.1038/s41598-020-66305-1']
2220,32541874,Abduction treatment in stable hip dysplasia does not alter the acetabular growth: results of a randomized clinical trial.,"Background The effect of bracing over natural history of stable dysplastic hips is not well known. This multicenter randomized trial aimed at objectifying the effect of abduction treatment versus active surveillance in infants of 3 to 4 months of age. Methods Patients were randomized to either Pavlik harness or active surveillance group. Ultrasound was repeated at 6 and 12 weeks post randomization. The primary outcome was the degree of dysplasia using the Graf α-angle at 6 months of age. The measurement of the acetabular index (AI) on plain pelvis X-rays was used to identify persistent dysplasia after 9 months and walking age (after 18 months). Findings The Pavlik harness group (n = 55) and active surveillance group (n = 49) were comparable for predictors of outcome. At 12 weeks follow-up the mean α-angle was 60.5° ± 3.8° in the Pavlik harness group and 60.0° ± 5.6° in the active surveillance group. (p = 0.30). Analysis of secondary outcomes (standard of care) showed no treatment differences for acetabular index at age 10 months (p = 0.82) and walking age (p = 0.35). Interpretation Pavlik harness treatment of stable but sonographic dysplastic hips has no effect on acetabular development. Eighty percent of the patients will have a normal development of the hip after twelve weeks. Therefore, we recommend observation rather than treatment for stable dysplastic hips.",2020,At 12 weeks follow-up the mean α-angle was 60.5° ± 3.8° in the Pavlik harness group and 60.0° ± 5.6° in the active surveillance group.,['infants of 3 to 4 months of age'],"['abduction treatment versus active surveillance', 'Pavlik harness or active surveillance group', 'Abduction treatment']","['acetabular growth', 'acetabular index', 'degree of dysplasia using the Graf α-angle']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C1319734', 'cui_str': 'Pavlik harness'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia'}, {'cui': 'C0205143', 'cui_str': 'Angular'}]",,0.20056,At 12 weeks follow-up the mean α-angle was 60.5° ± 3.8° in the Pavlik harness group and 60.0° ± 5.6° in the active surveillance group.,"[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Pollet', 'Affiliation': ""Royal Manchester Children's hospital, Department of Pediatric Orthopedics and Traumatology, Manchester, United Kingdom. virginie.pollet@nhs.net.""}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Castelein', 'Affiliation': 'University Medical Center Utrecht, Department of Orthopedics, Utrecht, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van de Sande', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Witbreuk', 'Affiliation': 'Amsterdam Medical University Center, Amsterdam, The Netherlands.'}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Mostert', 'Affiliation': 'Isala Hospital, Zwolle, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Besselaar', 'Affiliation': 'Maxima Medical Center, Eindhoven, The Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'van Bergen', 'Affiliation': 'University Medical Center Utrecht, Department of Orthopedics, Utrecht, The Netherlands.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Beek', 'Affiliation': 'University Medical Center Utrecht, Department of Radiology, Utrecht, The Netherlands.'}, {'ForeName': 'C S P M', 'Initials': 'CSPM', 'LastName': 'Uiterwaal', 'Affiliation': 'University Medical Center Utrecht, Julius Center for Health Sciences and Primary Care, Utrecht, The Netherlands.'}, {'ForeName': 'R J B', 'Initials': 'RJB', 'LastName': 'Sakkers', 'Affiliation': 'University Medical Center Utrecht, Department of Orthopedics, Utrecht, The Netherlands.'}]",Scientific reports,['10.1038/s41598-020-66634-1']
2221,32541882,Understanding how a community-based intervention for people with spinal cord injury in Bangladesh was delivered as part of a randomised controlled trial: a process evaluation.,"DESIGN


Mixed methods study SETTING: Community, Bangladesh OBJECTIVES: To understand how a community-based intervention for people with spinal cord injury (SCI) in Bangladesh was delivered as part of a randomised controlled trial and to gauge the perceptions of participants and healthcare professionals to the intervention.
METHODS


A community-based intervention was administered to 204 participants as part of a large randomised controlled trial (called the CIVIC trial). Case-managers followed-up participants with regular telephone calls and home visits over the first 2 years after discharge. The following data were collected alongside the trial: (i) chart audit of telephone calls and home visits (ii) recordings of 20 telephone calls (iii) interviews with 14 Intervention participants and four healthcare professionals including three case-managers.
RESULTS


Participants received the target number of telephone calls and home visits. Pressure injuries were identified as a problem during at least one telephone call by 43% of participants. Participants and case-managers valued regular telephone calls and home visits, and believed that calls and visits prevented complications and alleviated social isolation. Participants trusted case-managers and were confident in the care and advice provided. Case-managers expressed concerns that people with SCI in Bangladesh face many problems impacting on well-being and motivation stemming from poverty, limited employment opportunities, societal attitudes and inaccessible environments.
CONCLUSION


A community-based intervention involving regular telephone calls and home visits was administered as intended and was well received by the recipients of the care. Nonetheless, people with SCI in Bangladesh face economic and social problems which cannot be fully addressed by this type of intervention alone.",2020,A community-based intervention involving regular telephone calls and home visits was administered as intended and was well received by the recipients of the care.,"['people with spinal cord injury in Bangladesh', '204 participants as part of a large randomised controlled trial (called the CIVIC trial', 'people with spinal cord injury (SCI) in Bangladesh']","['community-based intervention', 'telephone calls and home visits (ii) recordings of 20 telephone calls (iii) interviews with 14 Intervention participants and four healthcare professionals including three case-managers']",['Pressure injuries'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0687694', 'cui_str': 'Case manager'}]","[{'cui': 'C0332679', 'cui_str': 'Crushing injury'}]",204.0,0.0864356,A community-based intervention involving regular telephone calls and home visits was administered as intended and was well received by the recipients of the care.,"[{'ForeName': 'Hueiming', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'Mohammad Sohrab', 'Initials': 'MS', 'LastName': 'Hossain', 'Affiliation': 'John Walsh Centre for Rehabilitation Research, Kolling Institute, Sydney Medical School/Northern, University of Sydney, St Leonards, NSW, Australia.'}, {'ForeName': 'Md Shofiqul', 'Initials': 'MS', 'LastName': 'Islam', 'Affiliation': 'Centre for the Rehabilitation of the Paralysed, Savar, Dhaka, Bangladesh.'}, {'ForeName': 'Md Akhlasur', 'Initials': 'MA', 'LastName': 'Rahman', 'Affiliation': 'Centre for the Rehabilitation of the Paralysed, Savar, Dhaka, Bangladesh.'}, {'ForeName': 'Punam D', 'Initials': 'PD', 'LastName': 'Costa', 'Affiliation': 'Centre for the Rehabilitation of the Paralysed, Savar, Dhaka, Bangladesh.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Herbert', 'Affiliation': 'Neuroscience Research Australia, Barker Street, Randwick, NSW, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Jan', 'Affiliation': 'George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Cameron', 'Affiliation': 'John Walsh Centre for Rehabilitation Research, Kolling Institute, Sydney Medical School/Northern, University of Sydney, St Leonards, NSW, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Muldoon', 'Affiliation': 'Muldoon Rehabilitation, 72 Liscreevin Road, Lisnarick, Co Fermanagh, BT, Northern Ireland, Northern Ireland.'}, {'ForeName': 'Harvinder S', 'Initials': 'HS', 'LastName': 'Chhabra', 'Affiliation': 'Indian Spinal Injuries Centre, Sector C, Vasant Kunj, New Delhi, India.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Lindley', 'Affiliation': 'George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'Fin', 'Initials': 'F', 'LastName': 'Biering-Sorensen', 'Affiliation': 'Clinic for Spinal Cord Injuries, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Ducharme', 'Affiliation': 'Boston Medical Centre and Boston University School of Medicine, 725 Albany street, Boston, MA, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Taylor', 'Affiliation': 'Centre for the Rehabilitation of the Paralysed, Savar, Dhaka, Bangladesh.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Harvey', 'Affiliation': 'John Walsh Centre for Rehabilitation Research, Kolling Institute, Sydney Medical School/Northern, University of Sydney, St Leonards, NSW, Australia. l.harvey@usyd.edu.au.'}]",Spinal cord,['10.1038/s41393-020-0495-6']
2222,32542068,Improving Language Comprehension to Enhance Word-Problem Solving.,"The focus of this article is the role of language comprehension within word-problem solving (WPS). The role of the language comprehension in WPS is explained, and an overview of research illustrating language comprehension's contribution to WPS is described. Next, an innovative intervention that embeds WP-specific language comprehension instruction within a validated form of schema-based WP intervention is described, and the methods and results of a randomized controlled trial assessing the added value of embedding WP-specific language comprehension instruction are outlined. Implications for practice and future research are drawn.",2020,"Next, an innovative intervention that embeds WP-specific language comprehension instruction within a validated form of schema-based WP intervention is described, and the methods and results of a randomized controlled trial assessing the added value of embedding WP-specific language comprehension instruction are outlined.",[],['language comprehension within word-problem solving (WPS'],[],[],"[{'cui': 'C0233733', 'cui_str': 'Language comprehension'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}]",[],,0.0258129,"Next, an innovative intervention that embeds WP-specific language comprehension instruction within a validated form of schema-based WP intervention is described, and the methods and results of a randomized controlled trial assessing the added value of embedding WP-specific language comprehension instruction are outlined.","[{'ForeName': 'Lynn S', 'Initials': 'LS', 'LastName': 'Fuchs', 'Affiliation': 'Vanderbilt University.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Fuchs', 'Affiliation': 'Vanderbilt University.'}, {'ForeName': 'Pamela M', 'Initials': 'PM', 'LastName': 'Seethaler', 'Affiliation': 'Vanderbilt University.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Craddock', 'Affiliation': 'Vanderbilt University.'}]",Reading & writing quarterly : overcoming learning difficulties,[]
2223,32542156,Impact of a Community-Based Weight Loss Program on Renal Function.,"Introduction Obesity is associated with increased morbidity and mortality and is an independent risk factor for the development and progression of chronic kidney disease (CKD). This study investigated the effect of a community-based, lifestyle-focused, weight-loss intervention on renal function among participants at baseline following 12 weeks of therapy.  Methods A retrospective analysis of adults enrolled in a weight management program from 2009 to 2014 was conducted. Participants consumed at least 800 kilocalories per day in meal replacements, attended weekly behavioral education classes, and expended approximately 300 kilocalories per day in physical activity. The primary outcome was the association of weight loss and changes in glomerular filtration rate (GFR). Secondary outcomes included changes in blood sugar levels, lipid parameters, blood pressure, and the use of medication for hypertension and diabetes mellitus.  Results Of the 71 participants, 63.4% were female, the average weight was 289 pounds, the average body mass index (BMI) of 53, and baseline GFR 47 ml/min/1.73m 2 . Following 12 weeks of the intervention, 76.1% of participants improved in CKD stage, 22.4% remained within the same stage, and 1.5% progressed to a higher stage (3A to 3B). Analysis revealed a correlation between weight loss and improved GFR (p=0.0006). Improvements were noted in blood sugar levels, blood pressure, and lipids (p<0.05). Medications were reduced in 61.8% of participants for hypertension and 83.3% for diabetes. Conclusions A significant correlation was observed between weight loss and improved renal function, with most participants improving in CKD stage. Participants also improved in markers of chronic disease and required fewer medications. When controlling for both diabetes and hypertension, the effect of improved renal function persisted.",2020,"Improvements were noted in blood sugar levels, blood pressure, and lipids (p<0.05).","['adults enrolled in a weight management program from 2009 to 2014 was conducted', '71 participants, 63.4% were female', 'participants at baseline\xa0following 12 weeks of therapy']","['Community-Based Weight Loss Program', 'community-based, lifestyle-focused, weight-loss intervention']","['blood sugar levels, blood pressure, and lipids (p<0.05', 'renal function', 'weight loss and improved renal function', 'Medications', 'markers of chronic disease and required fewer medications', 'association of weight loss and changes in glomerular filtration rate (GFR', 'weight loss and improved GFR', 'Renal Function', 'average weight', 'CKD stage', 'changes in blood sugar levels, lipid parameters, blood pressure, and the use of medication for hypertension and diabetes mellitus']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]",,0.0398855,"Improvements were noted in blood sugar levels, blood pressure, and lipids (p<0.05).","[{'ForeName': 'Tiffany E', 'Initials': 'TE', 'LastName': 'Schwasinger-Schmidt', 'Affiliation': 'Internal Medicine, Kansas University School of Medicine-Wichita, Wichita, USA.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Elhomsy', 'Affiliation': 'Internal Medicine, Kansas University School of Medicine-Wichita, Wichita, USA.'}, {'ForeName': 'Bobbie G', 'Initials': 'BG', 'LastName': 'Paull-Forney', 'Affiliation': 'Weight Management Clinic, Ascension Via Christi Hospitals, Wichita, USA.'}]",Cureus,['10.7759/cureus.8101']
2224,32534568,How does the EQ-5D-5L perform in asthma patients compared with an asthma-specific quality of life questionnaire?,"BACKGROUND


Asthma patients experience impairments in health-related quality of life (HRQL). Interventions are available to improve HRQL. EQ-5D-5L is a common generic tool used to evaluate health interventions. However, there is debate over whether the use of this measure is adequate in asthma patients.
METHODS


We used data from 371 asthma patients participating in a pulmonary rehabilitation (PR) program from the EPRA randomized controlled trial. We used four time points: T0 randomization, T1 start PR, T2 end PR, T3 3 months follow-up. We calculated floor and ceiling effects, intra-class correlation (ICC), Cohen's d, and regression analysis to measure the sensitivity to changes of EQ-5D-5 L (EQ-5D index and Visual Analog Scale (VAS)) and the disease-specific Asthma Quality of Life Questionnaire (AQLQ). Furthermore, we estimated the minimally important difference (MID). Based on the Asthma Control Test (ACT) scores, we defined three groups: 1. ACT-A (ACT> 19) controlled asthma, 2. ACT-B (14 < ACT≤19) not well-controlled asthma, and 3. ACT-C (ACT≤14) very poorly controlled asthma.
RESULTS


Only the EQ-5D index showed ceiling effects at T2 and T3 (32%). ICC (between T0 and T1) was moderate or good for all measures. Cohen's d at T2 and T3 was better at differentiating between ACT-A and ACT-B than between ACT-B and ACT-C. The EQ-5D index showed moderate effect sizes (0.63-0.75), while AQLQ showed large effect sizes (0.74-1,48). VAS was responsive to pronounced positive and negative ACT changes in every period, and AQLQ mostly to the positive changes, whereas the EQ-5D index was less responsive. We estimated a MID of 0.08 for the EQ-5D index, 12.3 for VAS, and 0.65 for AQLQ.
CONCLUSION


All presented HRQL tools had good discriminatory power and good reliability. However, EQ-5D-5 L did not react very sensitively to small changes in asthma control. Therefore, we would suggest using supplementary measures in addition to EQ-5D-5 L to evaluate asthma-specific interventions more comprehensively.
TRIAL REGISTRATION


German Clinical Trial Register, DRKS00007740 (date of registration: 05/15/2015), https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00007740. The registration took place prospectively.",2020,"The EQ-5D index showed moderate effect sizes (0.63-0.75), while AQLQ showed large effect sizes (0.74-1,48).","['asthma patients', '371 asthma patients participating in a pulmonary rehabilitation (PR) program from the EPRA randomized controlled trial', 'Asthma patients experience impairments in health-related quality of life (HRQL']","['EQ-5D-5L', 'VAS', 'EQ-5D-5']","['ICC', 'EQ-5D-5\u2009L (EQ-5D index and Visual Analog Scale (VAS)) and the disease-specific Asthma Quality of Life Questionnaire (AQLQ', 'EQ-5D index']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",371.0,0.068442,"The EQ-5D index showed moderate effect sizes (0.63-0.75), while AQLQ showed large effect sizes (0.74-1,48).","[{'ForeName': 'Boglárka L', 'Initials': 'BL', 'LastName': 'Szentes', 'Affiliation': 'Institute of Health Economics and Health Care Management, Helmholtz Zentrum München (GmbH) - German Research Center for Environmental Health, Comprehensive Pneumology Center Munich (CPC-M), Member of the German Center for Lung Research (DZL), Ingolstädter Landstraße 1, 85764, Neuherberg, Germany. szentesboglarka@gmail.com.'}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Schultz', 'Affiliation': 'Klinik Bad Reichenhall, Center for Rehabilitation, Pulmonology and Orthopedics, Salzburger Str. 8, 83435, Bad Reichenhall, Germany.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Nowak', 'Affiliation': 'LMU University of München, Institute and Outpatient Clinic for Occupational, Social and Environmental Medicine, Ziemssenstraße 1, 80336, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schuler', 'Affiliation': 'University of Würzburg, Institute of Clinical Epidemiology and Biometry, Sanderring 2, 97070, Würzburg, Germany.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Schwarzkopf', 'Affiliation': 'Institute of Health Economics and Health Care Management, Helmholtz Zentrum München (GmbH) - German Research Center for Environmental Health, Comprehensive Pneumology Center Munich (CPC-M), Member of the German Center for Lung Research (DZL), Ingolstädter Landstraße 1, 85764, Neuherberg, Germany.'}]",BMC pulmonary medicine,['10.1186/s12890-020-01205-8']
2225,32534578,"Rationale and design of an investigator-initiated, multicenter, prospective open-label, randomized trial to evaluate the effect of ipragliflozin on endothelial dysfunction in type 2 diabetes and chronic kidney disease: the PROCEED trial.","BACKGROUND


Type 2 diabetes (T2D) is associated with renal impairment and vascular endothelial dysfunction. Therefore, this pathological connection is an important therapeutic target. Recent cardiovascular and renal outcome trials demonstrated that sodium glucose cotransporter 2 inhibitors (SGLT2is) consistently reduced the risks of cardiovascular and renal events and mortality in patients with T2D and various other background risks including chronic kidney disease (CKD). However, the precise mechanisms by which SGLT2is accords these therapeutic benefits remain uncertain. It is also unknown whether these SGLT2is-associated benefits are associated with the amelioration of endothelial dysfunction in patients with T2D and CKD.
METHODS


The PROCEED trial is an investigator-initiated, prospective, multicenter, open-label, randomized-controlled trial. The target sample size is 110 subjects. After they furnish informed consent and their endothelial dysfunction is confirmed from their decreased reactive hyperemia indices (RHI), eligible participants with T2D (HbA1c, 6.0-9.0%) and established CKD (30 mL/min/1.73 m 2  ≤ estimated glomerular filtration ratio [eGFR] < 60 and/or ≥ urine albumin-to-creatinine ratio 30 mg/g Cr) will be randomized (1:1) to receive either 50 mg ipragliflozin daily or continuation of background treatment (non-SGLT2i). The primary endpoint is the change in RHI from baseline after 24 weeks. To compare the treatment effects between groups, the baseline-adjusted means and their 95% confidence intervals will be estimated by analysis of covariance adjusted for HbA1c (< 7.0% or ≥ 7.0%), age (< 70 y or ≥ 70 y), RHI (< 1.67 or ≥ 1.67), eGFR (< 45 mL/min/1.73 m 2  or ≥ 45 mL/min/1.73 m 2 ), and smoking status. Prespecified responder analyses will be also conducted to determine the proportions of patients with clinically meaningful changes in RHI at 24 weeks.
DISCUSSION


PROCEED is the first trial to examine the effects of ipragliflozin on endothelial dysfunction in patients with T2D and CKD. This ongoing trial will establish whether endothelial dysfunction is a therapeutic target of SGLT2is in this population. It will also provide deep insights into the potential mechanisms by which SGLT2is reduced the risks of cardiovascular and renal events in recent outcome trials. Trial registration Unique Trial Number, jRCTs071190054 (https://jrct.niph.go.jp/en-latest-detail/jRCTs071190054).",2020,"After they furnish informed consent and their endothelial dysfunction is confirmed from their decreased reactive hyperemia indices (RHI), eligible participants with T2D (HbA1c, 6.0-9.0%) and established CKD (30 mL","['110 subjects', 'patients with T2D and various other background risks including chronic kidney disease (CKD', 'type 2 diabetes and chronic kidney disease', 'patients with T2D and CKD']","['ipragliflozin daily or continuation of background treatment (non-SGLT2i', 'sodium glucose cotransporter 2 inhibitors (SGLT2is', 'ipragliflozin']","['glomerular filtration ratio [eGFR', 'change in RHI', 'and/or\u2009≥\u2009urine albumin-to-creatinine ratio 30', 'reactive hyperemia indices', 'risks of cardiovascular and renal events and mortality', 'endothelial dysfunction']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C3492889', 'cui_str': 'ipragliflozin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0232809', 'cui_str': 'Glomerular filtration'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042038', 'cui_str': 'Albumin urine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}]",,0.113996,"After they furnish informed consent and their endothelial dysfunction is confirmed from their decreased reactive hyperemia indices (RHI), eligible participants with T2D (HbA1c, 6.0-9.0%) and established CKD (30 mL","[{'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Tanaka', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan. tanakaa2@cc.saga-u.ac.jp.'}, {'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Shimabukuro', 'Affiliation': 'Department of Diabetes, Endocrinology, and Metabolism, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Okada', 'Affiliation': 'The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Sugimoto', 'Affiliation': 'Diabetes Center, Ohta Nishinouchi Hospital, Koriyama, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Kurozumi', 'Affiliation': 'Wakamatsu Hospital of the University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Torimoto', 'Affiliation': 'The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Hirai', 'Affiliation': 'Department of Diabetes, Endocrinology, and Metabolism, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Node', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan. node@cc.saga-u.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cardiovascular diabetology,['10.1186/s12933-020-01065-w']
2226,32534582,Efficacy of throwing exercise with TheraBand in male volleyball players with shoulder internal rotation deficit: a randomized controlled trial.,"BACKGROUND


The Glenohumeral internal-rotation deficit (GIRD) is related to the altered eccentric external-rotator (ER), the concentric internal-rotator (IR), muscle strength, and the ER: IR ratio. GIRD has been documented as a risk factor for shoulder injuries. However, few studies have investigated the effect of an exercise training on these parameters in athletes with GIRD. Therefore, the purpose of this study was to evaluate the effects of an 8-week throwing exercise with a TheraBand for retraining the rotator cuff on Electromyography (EMG) activity of selected muscles, rotator cuff muscle strength, the glenohumeral (GH) joint IR range of motion (ROM) and GH joint position sense in asymptomatic male volleyball players with GIRD.
METHODS


Sixty male volleyball players with GIRD were randomized into either a training group or a control group. The experimental group underwent an 8-week throwing exercise with a TheraBand including 5 sessions of stretching and 3 sessions of strengthening exercises per week. The control group received an active self-exercise program. EMG (onset time and muscle activation), shoulder range of motion (ROMs), strength and GH joint position sense were all assessed pre and post trainings.
RESULTS


There were statistically significant within-group differences in the EMG activity of the anterior deltoid (p = 0.005), middle deltoid (p = 0.007), posterior deltoid (p = 0.004), infraspinatus (p = 0.001) and supraspinatus (p = 0.001) muscles, IR ROM (p = 0.001), rotator cuff muscle strength ratio (p = 0.001), and GH joint position sense (p = 0.033) in the experimental group. A 2 × 2 analysis of variance with a mixed model design and independent and paired t-tests were used for statistical analysis.
CONCLUSIONS


Throwing exercise with a TheraBand improved shoulder muscle activation, IR ROM, rotator cuff muscle strength ratio and GH joint position sense in participants with GIRD. These findings may improve the treatment of GIRD in a clinical setting. Although the results are significant, further studies should follow up the long-term effects of the Throwing exercise with a TheraBand on GIRD.
TRIAL REGISTRATION


Current Controlled Trials using the UMIN-RCT website with ID number of, UMIN000038416 ""Retrospectively registered"" at 2019/10/29.",2020,"CONCLUSIONS


Throwing exercise with a TheraBand improved shoulder muscle activation, IR ROM, rotator cuff muscle strength ratio and GH joint position sense in participants with GIRD.","['asymptomatic male volleyball players with GIRD', 'male volleyball players with shoulder internal rotation deficit', 'athletes with GIRD', 'participants with GIRD', 'Sixty male volleyball players with GIRD']","['exercise training', '8-week throwing exercise with a TheraBand for retraining the rotator cuff', 'throwing exercise with TheraBand', 'active self-exercise program', '8-week throwing exercise with a TheraBand including 5 sessions of stretching and 3 sessions of strengthening exercises per week']","['rotator cuff muscle strength ratio', 'EMG activity of the anterior deltoid', 'middle deltoid', 'shoulder muscle activation, IR ROM, rotator cuff muscle strength ratio and GH joint position sense', 'GH joint position sense', 'EMG (onset time and muscle activation), shoulder range of motion (ROMs), strength and GH joint position sense', 'Electromyography (EMG) activity of selected muscles, rotator cuff muscle strength, the glenohumeral (GH) joint IR range of motion (ROM) and GH joint position sense', 'posterior deltoid']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1956059', 'cui_str': 'Volleyball'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C1959673', 'cui_str': 'Muscle of rotator cuff'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0224234', 'cui_str': 'Structure of deltoid muscle'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0687023', 'cui_str': 'Structure of skeletal muscle of shoulder'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0037009', 'cui_str': 'Joint structure of shoulder region'}, {'cui': 'C0234219', 'cui_str': 'Postural sense'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0575545', 'cui_str': 'Shoulder joint - range of movement'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}]",60.0,0.0339266,"CONCLUSIONS


Throwing exercise with a TheraBand improved shoulder muscle activation, IR ROM, rotator cuff muscle strength ratio and GH joint position sense in participants with GIRD.","[{'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Moradi', 'Affiliation': 'Faculty of Physical Education and Sport sciences, Department of Biomechanics and Sport injuries, Kharazmi University, Tehran, Islamic Republic of Iran.'}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Hadadnezhad', 'Affiliation': 'Department of Biomechanics and Sport injuries, Kharazmi University, Tehran, Islamic Republic of Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Letafatkar', 'Affiliation': 'Department of Biomechanics and Sport injuries, Kharazmi University, Tehran, Islamic Republic of Iran. letafatkaramir@yahoo.com.'}, {'ForeName': 'Zohre', 'Initials': 'Z', 'LastName': 'Khosrokiani', 'Affiliation': 'Faculty of Physical Education and Sport sciences, Department of Biomechanics and Sport injuries, Kharazmi University, Tehran, Islamic Republic of Iran.'}, {'ForeName': 'Julien S', 'Initials': 'JS', 'LastName': 'Baker', 'Affiliation': 'Centre for Health and Exercise Science Research, Hong Kong Baptist University, Kowloon Tong, Hong Kong.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03414-y']
2227,32534584,Effect of continuous intraoperative infusion of methoxamine on renal function in elderly patients undergoing gastrointestinal tumor surgery: a randomized controlled trial.,"BACKGROUND


Acute renal injury (AKI) caused by hypotension often occurs in elderly patients after gastrointestinal tumor surgery. Although vasoactive drugs can increase effective filtration pressure, they may increase renal vascular resistance and reduce renal blood flow. The effect of methoxamine on renal function is not clear.
METHODS


After obtaining written informed consent, 180 elderly patients undergoing elective gastrointestinal tumor surgery were randomly allocated into two groups: M group (continuous infusion of methoxamine at 2 μg/kg/min) and N group (continuous infusion of normal saline). The patients' mean arterial pressure was maintained within 20% of baseline by a continuous infusion of methoxamine or normal saline. Maintenance fluid was kept at 5 mL/kg/h. According to Kidney disease improve global outcome (KDIGO) guidelines, creatinine was measured at 1, 2 and 7 days after operation, and urine volume at 6, 12 and 24 h after operation was measured to evaluate the occurrence of AKI. 162 patients were included in the final data analysis.
RESULTS


Significant differences in the incidence of postoperative Acute kidney injury (M group: 7.5%; N group: 18.3%; P < 0.05), the frequency of hypotension (M group: 1 [1-3]; N group: 3 [1-5]; P < 0.05), and the duration of intraoperative hypotension (M group: 2[0-10]; N group: 10 [5-16]; P < 0.05) were identified between the groups. Multivariate logistic regression analyses demonstrated that preoperative creatinine and the frequency of intraoperative hypotension were the common factors leading to the occurrence of postoperative AKI. The results of Cox multivariate analysis showed that age and AKI were independent risk factors for 30-day death.
CONCLUSION


Compared with the intraoperative continuous infusion of placebo and methoxamine, continuous infusion of 2 μg/kg/min methoxamine reduced the incidence of postoperative AKI and other clinical complications in elderly patients undergoing gastrointestinal surgery by raising blood pressure and improved the prognosis of patients.
TRIAL REGISTRATION


Trial registration: Chinese Clinical Trial Registry, ChiCTR1900020536, registered 7 January, 2019.",2020,"RESULTS


Significant differences in the incidence of postoperative Acute kidney injury (M group: 7.5%; N group: 18.3%; P < 0.05), the frequency of hypotension (M group: 1 [1-3]; N group: 3 [1-5]; P < 0.05), and the duration of intraoperative hypotension (M group: 2[0-10]; N group: 10 [5-16]; P < 0.05) were identified between the groups.","['elderly patients after gastrointestinal tumor surgery', 'elderly patients undergoing gastrointestinal tumor surgery', 'elderly patients undergoing gastrointestinal surgery', '180 elderly patients undergoing elective gastrointestinal tumor surgery', '162 patients were included in the final data analysis']","['placebo and methoxamine', 'M group (continuous infusion of methoxamine at 2\u2009μg/kg/min) and N group (continuous infusion of normal saline', 'methoxamine or normal saline', 'continuous intraoperative infusion of methoxamine', 'methoxamine']","['renal function', 'incidence of postoperative AKI', 'renal vascular resistance and reduce renal blood flow', 'frequency of hypotension', 'effective filtration pressure', 'mean arterial pressure', 'global outcome (KDIGO) guidelines, creatinine', 'duration of intraoperative hypotension', 'occurrence of AKI', 'incidence of postoperative Acute kidney injury']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017185', 'cui_str': 'Neoplasm of gastrointestinal tract'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0524722', 'cui_str': 'Gastrointestinal surgery'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025681', 'cui_str': 'Methoxamine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C1532757', 'cui_str': 'kg/min'}, {'cui': 'C1278442', 'cui_str': 'Continuous infusion of normal saline'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0042380', 'cui_str': 'Vascular resistance, function'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035070', 'cui_str': 'Circulation, Renal'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0016107', 'cui_str': 'Filtration'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1112259', 'cui_str': 'Intraoperative hypotension'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",162.0,0.272553,"RESULTS


Significant differences in the incidence of postoperative Acute kidney injury (M group: 7.5%; N group: 18.3%; P < 0.05), the frequency of hypotension (M group: 1 [1-3]; N group: 3 [1-5]; P < 0.05), and the duration of intraoperative hypotension (M group: 2[0-10]; N group: 10 [5-16]; P < 0.05) were identified between the groups.","[{'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Xuzhou Medical University, Key Laboratory of Anesthesia and Analgesia, Xuzhou Medical University, Xuzhou, Jangsu, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Xuzhou Medical University and Department of Oncology, Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jangsu, China.'}, {'ForeName': 'Hanbing', 'Initials': 'H', 'LastName': 'Xiao', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Xuzhou Medical University, Key Laboratory of Anesthesia and Analgesia, Xuzhou Medical University, Xuzhou, Jangsu, China.'}, {'ForeName': 'Tianyu', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Xuzhou Medical University, Key Laboratory of Anesthesia and Analgesia, Xuzhou Medical University, Xuzhou, Jangsu, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Niu', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Xuzhou Medical University, Key Laboratory of Anesthesia and Analgesia, Xuzhou Medical University, Xuzhou, Jangsu, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Xuzhou Medical University, Key Laboratory of Anesthesia and Analgesia, Xuzhou Medical University, Xuzhou, Jangsu, China.'}, {'ForeName': 'Dunyi', 'Initials': 'D', 'LastName': 'Qi', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Xuzhou Medical University, Key Laboratory of Anesthesia and Analgesia, Xuzhou Medical University, Xuzhou, Jangsu, China. qdy6808@163.com.'}]",BMC anesthesiology,['10.1186/s12871-020-01064-0']
2228,32534628,"Safety and immunogenicity of a mosquito saliva peptide-based vaccine: a randomised, placebo-controlled, double-blind, phase 1 trial.","BACKGROUND


In animal models, immunity to mosquito salivary proteins protects animals against mosquito-borne disease. These findings provide a rationale to vaccinate against mosquito saliva instead of the pathogen itself. To our knowledge, no vector salivary protein-based vaccine has been tested for safety and immunogenicity in humans. We aimed to assess the safety and immunogenicity of Anopheles gambiae saliva vaccine (AGS-v), a peptide-based vaccine derived from four A gambiae salivary proteins, in humans.
METHODS


In this randomised, placebo-controlled, double-blind, phase 1 trial, participants were enrolled at the National Institutes of Health Clinical Center in Bethesda, MD, USA. Participants were eligible if they were healthy adults, aged 18-50 years with no history of severe allergic reactions to mosquito bites. Participants were randomly assigned (1:1:1), using block randomisation and a computer-generated randomisation sequence, to treatment with either 200 nmol of AGS-v vaccine alone, 200 nmol of AGS-v with adjuvant (Montanide ISA 51), or sterile water as placebo. Participants and clinicians were masked to treatment assignment. Participants were given a subcutaneous injection of their allocated treatment at day 0 and day 21, followed by exposure to feeding by an uninfected Aedes aegypti mosquito at day 42 to assess subsequent risk to mosquito bites in a controlled setting. The primary endpoints were safety and immunogenicity at day 42 after the first immunisation. Participants who were given at least one dose of assigned treatment were assessed for the primary endpoints and analysis was by intention to treat. The trial was registered with ClinicalTrials.gov, NCT03055000, and is closed for accrual.
FINDINGS


Between Feb 15 and Sept 10, 2017, we enrolled and randomly assigned 49 healthy adult participants to the adjuvanted vaccine (n=17), vaccine alone (n=16), or placebo group (n=16). Five participants did not complete the two-injection regimen with mosquito feeding at day 42, but were included in the safety analyses. No systemic safety concerns were identified; however, one participant in the adjuvanted vaccine group developed a grade 3 erythematous rash at the injection site. Pain, swelling, erythema, and itching were the most commonly reported local symptoms and were significantly increased in the adjuvanted vaccine group compared with both other treatment groups (nine [53%] of 17 participants in the adjuvanted vaccine group, two [13%] of 16 in the vaccine only group, and one [6%] of 16 in the placebo group; p=0·004). By day 42, participants who were given the adjuvanted vaccine had a significant increase in vaccine-specific total IgG antibodies compared with at baseline than did participants who were give vaccine only (absolute difference of log 10 -fold change of 0·64 [95% CI 0·39 to 0·89]; p=0·0002) and who were given placebo (0·62 [0·34 to 0·91]; p=0·0001). We saw a significant increase in IFN-γ production by peripheral blood mononuclear cells at day 42 in the adjuvanted vaccine group compared with in the placebo group (absolute difference of log 10  ratio of vaccine peptide-stimulated vs negative control 0·17 [95% CI 0·061 to 0·27]; p=0·009) but we saw no difference between the IFN-γ production in the vaccine only group compared with the placebo group (0·022 [-0·072 to 0·116]; p=0·63).
INTERPRETATION


AGS-v was well tolerated, and, when adjuvanted, immunogenic. These findings suggest that vector-targeted vaccine administration in humans is safe and could be a viable option for the increasing burden of vector-borne disease.
FUNDING


Office of the Director and the Division of Intramural Research at the National Institute of Allergy and Infectious Diseases, and National Institutes of Health.",2020,We saw a significant increase in IFN-γ production by peripheral blood mononuclear cells at day 42 in the adjuvanted vaccine group compared with in the placebo group (absolute difference of log 10  ratio of vaccine peptide-stimulated vs negative control 0·17,"['Participants were eligible if they were healthy adults, aged 18-50 years with no history of severe allergic reactions to mosquito bites', '49 healthy adult participants to the adjuvanted vaccine (n=17', 'Between Feb 15 and Sept 10, 2017', 'participants were enrolled at the National Institutes of Health Clinical Center in Bethesda, MD, USA']","['AGS-v vaccine alone, 200 nmol of AGS-v with adjuvant (Montanide ISA 51), or sterile water as placebo', 'vaccine alone', 'Anopheles gambiae saliva vaccine (AGS-v), a peptide-based vaccine', 'mosquito saliva peptide-based vaccine', 'placebo']","['Safety and immunogenicity', 'vaccine-specific total IgG antibodies', 'Pain, swelling, erythema, and itching', 'grade 3 erythematous rash', 'IFN-γ production', 'safety and immunogenicity', 'IFN-γ production by peripheral blood mononuclear cells']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0417744', 'cui_str': 'Mosquito bite'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439191', 'cui_str': 'nmol'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C1311732', 'cui_str': 'montanide ISA 51'}, {'cui': 'C0359299', 'cui_str': 'sterile water'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4047355', 'cui_str': 'Mosquito saliva'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0234913', 'cui_str': 'Rash erythematous'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}]",49.0,0.7465,We saw a significant increase in IFN-γ production by peripheral blood mononuclear cells at day 42 in the adjuvanted vaccine group compared with in the placebo group (absolute difference of log 10  ratio of vaccine peptide-stimulated vs negative control 0·17,"[{'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Manning', 'Affiliation': 'Laboratory of Malaria and Vector Research, National Institutes of Health, Bethesda, MD, USA. Electronic address: jessica.manning@nih.gov.'}, {'ForeName': 'Fabiano', 'Initials': 'F', 'LastName': 'Oliveira', 'Affiliation': 'Laboratory of Malaria and Vector Research, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Iliano V', 'Initials': 'IV', 'LastName': 'Coutinho-Abreu', 'Affiliation': 'Laboratory of Malaria and Vector Research, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Herbert', 'Affiliation': 'Laboratory of Malaria and Vector Research, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Meneses', 'Affiliation': 'Laboratory of Malaria and Vector Research, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Shaden', 'Initials': 'S', 'LastName': 'Kamhawi', 'Affiliation': 'Laboratory of Malaria and Vector Research, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Holly Ann', 'Initials': 'HA', 'LastName': 'Baus', 'Affiliation': 'LID Clinical Studies Unit, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Han', 'Affiliation': 'LID Clinical Studies Unit, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Czajkowski', 'Affiliation': 'LID Clinical Studies Unit, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Luz Angela', 'Initials': 'LA', 'LastName': 'Rosas', 'Affiliation': 'LID Clinical Studies Unit, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Cervantes-Medina', 'Affiliation': 'LID Clinical Studies Unit, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Rani', 'Initials': 'R', 'LastName': 'Athota', 'Affiliation': 'LID Clinical Studies Unit, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Reed', 'Affiliation': 'LID Clinical Studies Unit, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Allyson', 'Initials': 'A', 'LastName': 'Mateja', 'Affiliation': 'Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, sponsored by the National Cancer Institute, National Institutes of Health, Frederick, MD, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Hunsberger', 'Affiliation': 'Biostatistics Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'James', 'Affiliation': 'SEEK, PepTcell, London, UK.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Pleguezuelos', 'Affiliation': 'SEEK, PepTcell, London, UK.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Stoloff', 'Affiliation': 'SEEK, PepTcell, London, UK.'}, {'ForeName': 'Jesus G', 'Initials': 'JG', 'LastName': 'Valenzuela', 'Affiliation': 'Laboratory of Malaria and Vector Research, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Memoli', 'Affiliation': 'LID Clinical Studies Unit, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31048-5']
2229,32534646,"Atezolizumab, vemurafenib, and cobimetinib as first-line treatment for unresectable advanced BRAF V600  mutation-positive melanoma (IMspire150): primary analysis of the randomised, double-blind, placebo-controlled, phase 3 trial.","BACKGROUND


IMspire150 aimed to evaluate first-line combination treatment with BRAF plus MEK inhibitors and immune checkpoint therapy in BRAF V600  mutation-positive advanced or metastatic melanoma.
METHODS


IMspire150 was a randomised, double-blind, placebo-controlled phase 3 study done at 112 institutes in 20 countries. Patients with unresectable stage IIIc-IV, BRAF V600  mutation-positive melanoma were randomly assigned 1:1 to 28-day cycles of atezolizumab, vemurafenib, and cobimetinib (atezolizumab group) or atezolizumab placebo, vemurafenib, and cobimetinib (control group). In cycle 1, all patients received vemurafenib and cobimetinib only; atezolizumab placebo was added from cycle 2 onward. Randomisation was stratified by lactate dehydrogenase concentration and geographical region. Blinding for atezolizumab was achieved by means of an identical intravenous placebo, and blinding for vemurafenib was achieved by means of a placebo tablet. The primary outcome was investigator-assessed progression-free survival. This trial (ClinicalTrials.gov, NCT02908672) is ongoing but no longer recruiting patients.
FINDINGS


Between Jan 13, 2017, and April 26, 2018, 777 patients were screened and 514 were enrolled and randomly assigned to the atezolizumab group (n=256) or control group (n=258). At a median follow-up of 18·9 months (IQR 10·4-23·8), progression-free survival as assessed by the study investigator was significantly prolonged with atezolizumab versus control (15·1 vs 10·6 months; hazard ratio [HR] 0·78; 95% CI 0·63-0·97; p=0·025). Common treatment-related adverse events (>30%) in the atezolizumab and control groups were blood creatinine phosphokinase increased (51·3% vs 44·8%), diarrhoea (42·2% vs 46·6%), rash (40·9%, both groups), arthralgia (39·1% vs 28·1%), pyrexia (38·7% vs 26·0%), alanine aminotransferase increased (33·9% vs 22·8%), and lipase increased (32·2% vs 27·4%); 13% of patients in the atezolizumab group and 16% in the control group stopped all treatment because of adverse events.
INTERPRETATION


The addition of atezolizumab to targeted therapy with vemurafenib and cobimetinib was safe and tolerable and significantly increased progression-free survival in patients with BRAF V600  mutation-positive advanced melanoma.
FUNDING


F Hoffmann-La Roche and Genentech.",2020,"Common treatment-related adverse events (>30%) in the atezolizumab and control groups were blood creatinine phosphokinase increased (51·3% vs 44·8%), diarrhoea (42·2% vs 46·6%), rash (40·9%, both groups), arthralgia (39·1% vs 28·1%), pyrexia (38·7% vs 26·0%), alanine aminotransferase increased (33·9% vs 22·8%), and lipase increased (32·2% vs 27·4%); 13% of patients in the atezolizumab group and 16% in the control group stopped all treatment because of adverse events.
","['Between Jan 13, 2017, and April 26, 2018, 777 patients were screened and 514 were enrolled and randomly assigned to the', 'Patients with unresectable stage IIIc-IV, BRAF V600  mutation-positive melanoma', 'patients with BRAF V600  mutation-positive advanced melanoma', 'controlled phase 3 study done at 112 institutes in 20 countries', 'BRAF V600  mutation-positive advanced or metastatic melanoma', 'group (n=256) or control group (n=258']","['BRAF plus MEK inhibitors', 'Atezolizumab, vemurafenib, and cobimetinib', 'atezolizumab, vemurafenib, and cobimetinib (atezolizumab group) or atezolizumab placebo, vemurafenib, and cobimetinib (control group', 'atezolizumab', 'vemurafenib and cobimetinib only; atezolizumab placebo', 'vemurafenib and cobimetinib', 'placebo']","['progression-free survival', 'diarrhoea', 'pyrexia', 'alanine aminotransferase', 'investigator-assessed progression-free survival', 'blood creatinine phosphokinase', 'adverse events', 'rash', 'arthralgia', 'lipase']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0456608', 'cui_str': 'Stage 3C'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0383375', 'cui_str': 'AT 112'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2347168', 'cui_str': 'Mitogen-activated protein kinase kinase inhibitor'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C3192263', 'cui_str': 'Vemurafenib'}, {'cui': 'C4049146', 'cui_str': 'Cobimetinib'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0201975', 'cui_str': 'Creatinine measurement'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0023764', 'cui_str': 'Lipase'}]",777.0,0.732647,"Common treatment-related adverse events (>30%) in the atezolizumab and control groups were blood creatinine phosphokinase increased (51·3% vs 44·8%), diarrhoea (42·2% vs 46·6%), rash (40·9%, both groups), arthralgia (39·1% vs 28·1%), pyrexia (38·7% vs 26·0%), alanine aminotransferase increased (33·9% vs 22·8%), and lipase increased (32·2% vs 27·4%); 13% of patients in the atezolizumab group and 16% in the control group stopped all treatment because of adverse events.
","[{'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Gutzmer', 'Affiliation': 'Haut-Tumor-Zentrum Hannover, Klinik für Dermatologie, Allergologie und Venerologie, Medizinische Hochschule Hannover, Hannover, Germany. Electronic address: gutzmer.ralf@mh-hannover.de.'}, {'ForeName': 'Daniil', 'Initials': 'D', 'LastName': 'Stroyakovskiy', 'Affiliation': 'Moscow City Oncology Hospital Number 62 of Moscow Healthcare Department, Moscow, Russia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Gogas', 'Affiliation': 'First Department of Medicine, Laiko General Hospital, National and Kapodistrian University of Athens, Greece.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Gustave Roussy and Université Paris-Saclay, Villejuif-Paris, France.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Lewis', 'Affiliation': 'University of Colorado Comprehensive Cancer Center, Aurora, CO, USA.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Protsenko', 'Affiliation': 'Department of Chemotherapy and Innovative Technologies, NN Petrov National Medical Research Center of Oncology, St Petersburg, Russia.'}, {'ForeName': 'Rodrigo P', 'Initials': 'RP', 'LastName': 'Pereira', 'Affiliation': 'Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Eigentler', 'Affiliation': 'University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Department of Soft Tissue-Bone Sarcoma and Melanoma, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'Lev', 'Initials': 'L', 'LastName': 'Demidov', 'Affiliation': 'NN Blokhin Russian Cancer Research Center, Ministry of Health, Moscow, Russia.'}, {'ForeName': 'Georgy Moiseevich', 'Initials': 'GM', 'LastName': 'Manikhas', 'Affiliation': 'St Petersburg Oncology Hospital, St Petersburg, Russia.'}, {'ForeName': 'Yibing', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Kuan-Chieh', 'Initials': 'KC', 'LastName': 'Huang', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Uyei', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'McNally', 'Affiliation': 'Roche Products, Welwyn Garden City, UK.'}, {'ForeName': 'Grant A', 'Initials': 'GA', 'LastName': 'McArthur', 'Affiliation': 'Melanoma and Skin Service and Cancer Therapeutics Program, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Istituto Nazionale Tumori IRCCS Fondazione G Pascale, Naples, Italy.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)30934-X']
2230,32534647,"Cancer prevention with aspirin in hereditary colorectal cancer (Lynch syndrome), 10-year follow-up and registry-based 20-year data in the CAPP2 study: a double-blind, randomised, placebo-controlled trial.","BACKGROUND


Lynch syndrome is associated with an increased risk of colorectal cancer and with a broader spectrum of cancers, especially endometrial cancer. In 2011, our group reported long-term cancer outcomes (mean follow-up 55·7 months [SD 31·4]) for participants with Lynch syndrome enrolled into a randomised trial of daily aspirin versus placebo. This report completes the planned 10-year follow-up to allow a longer-term assessment of the effect of taking regular aspirin in this high-risk population.
METHODS


In the double-blind, randomised CAPP2 trial, 861 patients from 43 international centres worldwide (707 [82%] from Europe, 112 [13%] from Australasia, 38 [4%] from Africa, and four [<1%] from The Americas) with Lynch syndrome were randomly assigned to receive 600 mg aspirin daily or placebo. Cancer outcomes were monitored for at least 10 years from recruitment with English, Finnish, and Welsh participants being monitored for up to 20 years. The primary endpoint was development of colorectal cancer. Analysis was by intention to treat and per protocol. The trial is registered with the ISRCTN registry, number ISRCTN59521990.
FINDINGS


Between January, 1999, and March, 2005, 937 eligible patients with Lynch syndrome, mean age 45 years, commenced treatment, of whom 861 agreed to be randomly assigned to the aspirin group or placebo; 427 (50%) participants received aspirin and 434 (50%) placebo. Participants were followed for a mean of 10 years approximating 8500 person-years. 40 (9%) of 427 participants who received aspirin developed colorectal cancer compared with 58 (13%) of 434 who received placebo. Intention-to-treat Cox proportional hazards analysis revealed a significantly reduced hazard ratio (HR) of 0·65 (95% CI 0·43-0·97; p=0·035) for aspirin versus placebo. Negative binomial regression to account for multiple primary events gave an incidence rate ratio of 0·58 (0·39-0·87; p=0·0085). Per-protocol analyses restricted to 509 who achieved 2 years' intervention gave an HR of 0·56 (0·34-0·91; p=0·019) and an incidence rate ratio of 0·50 (0·31-0·82; p=0·0057). Non-colorectal Lynch syndrome cancers were reported in 36 participants who received aspirin and 36 participants who received placebo. Intention-to-treat and per-protocol analyses showed no effect. For all Lynch syndrome cancers combined, the intention-to-treat analysis did not reach significance but per-protocol analysis showed significantly reduced overall risk for the aspirin group (HR=0·63, 0·43-0·92; p=0·018). Adverse events during the intervention phase between aspirin and placebo groups were similar, and no significant difference in compliance between intervention groups was observed for participants with complete intervention phase data; details reported previously.
INTERPRETATION


The case for prevention of colorectal cancer with aspirin in Lynch syndrome is supported by our results.
FUNDING


Cancer Research UK, European Union, MRC, NIHR, Bayer Pharma AG, Barbour Foundation.",2020,"Adverse events during the intervention phase between aspirin and placebo groups were similar, and no significant difference in compliance between intervention groups was observed for participants with complete intervention phase data; details reported previously.
","['861 patients from 43 international centres worldwide (707 [82%] from Europe, 112 [13%] from Australasia, 38 [4%] from Africa, and four [<1%] from The Americas) with Lynch syndrome', 'hereditary colorectal cancer (Lynch syndrome', 'Participants were followed for a mean of 10 years approximating 8500 person-years', '937 eligible patients with Lynch syndrome, mean age 45 years, commenced treatment, of whom 861 agreed to be randomly assigned to the', '427 participants who received', 'and 36 participants who received']","['aspirin group or placebo', 'aspirin versus placebo', 'aspirin', 'aspirin daily or placebo', 'placebo']","['development of colorectal cancer', 'Adverse events', 'long-term cancer outcomes', 'hazard ratio (HR) of 0·65', 'overall risk', 'colorectal cancer', 'compliance', 'Cancer outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0282279', 'cui_str': 'Australasia'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0002454', 'cui_str': 'America'}, {'cui': 'C1333990', 'cui_str': 'HNPCC - hereditary nonpolyposis colon cancer'}, {'cui': 'C0439660', 'cui_str': 'Hereditary'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4517893', 'cui_str': '8500'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",861.0,0.749563,"Adverse events during the intervention phase between aspirin and placebo groups were similar, and no significant difference in compliance between intervention groups was observed for participants with complete intervention phase data; details reported previously.
","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Burn', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK. Electronic address: john.burn@newcastle.ac.uk.'}, {'ForeName': 'Harsh', 'Initials': 'H', 'LastName': 'Sheth', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Faye', 'Initials': 'F', 'LastName': 'Elliott', 'Affiliation': ""Division of Haematology and Immunology, Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Reed', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Finlay', 'Initials': 'F', 'LastName': 'Macrae', 'Affiliation': 'Colorectal Medicine and Genetics, Royal Melbourne Hospital, Melbourne, Australia.'}, {'ForeName': 'Jukka-Pekka', 'Initials': 'JP', 'LastName': 'Mecklin', 'Affiliation': 'Department of Education & Research, Jyväskylä Central Hospital, Jyväskylä, Finland; Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Möslein', 'Affiliation': 'St Josefs-Hospital, Bochum-Linden, Germany.'}, {'ForeName': 'Fiona E', 'Initials': 'FE', 'LastName': 'McRonald', 'Affiliation': 'National Cancer Registration and Analysis Service, Public Health England, London, UK.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Bertario', 'Affiliation': 'Instituto Nazionale per lo Studio e, la Cura dei Tumori, Milan, Italy.'}, {'ForeName': 'D Gareth', 'Initials': 'DG', 'LastName': 'Evans', 'Affiliation': ""Division of Evolution and Genomic Medicine, University of Manchester, Manchester, UK; St Mary's Hospital, Manchester Universities Foundation Trust, Manchester, UK.""}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Gerdes', 'Affiliation': 'Clinical Genetics, Rigshospital, Copenhagen, Denmark.'}, {'ForeName': 'Judy W C', 'Initials': 'JWC', 'LastName': 'Ho', 'Affiliation': 'Hereditary GI Cancer Registry, Department of Surgery, Queen Mary Hospital, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Lindblom', 'Affiliation': 'Department of Molecular Medicine & Surgery, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Morrison', 'Affiliation': 'Department of Medical Genetics, Queens University Belfast, Belfast City Hospital HSC Trust, Belfast, UK.'}, {'ForeName': 'Jem', 'Initials': 'J', 'LastName': 'Rashbass', 'Affiliation': 'National Cancer Registration and Analysis Service, Public Health England, London, UK.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Ramesar', 'Affiliation': 'Genomic and Precision Medicine Research Unit, Division of Human Genetics, Institute of Infectious Diseases and Molecular Medicine, Faculty of Health Sciences, University of Cape Town, South Africa.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Seppälä', 'Affiliation': 'Department of Gastrointestinal Surgery, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Huw J W', 'Initials': 'HJW', 'LastName': 'Thomas', 'Affiliation': ""St Mark's Hospital, London, UK; Faculty of Medicine, Imperial College London, London, UK.""}, {'ForeName': 'Kirsi', 'Initials': 'K', 'LastName': 'Pylvänäinen', 'Affiliation': 'Department of Education & Research, Jyväskylä Central Hospital, Jyväskylä, Finland.'}, {'ForeName': 'Gillian M', 'Initials': 'GM', 'LastName': 'Borthwick', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Mathers', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'D Timothy', 'Initials': 'DT', 'LastName': 'Bishop', 'Affiliation': ""Division of Haematology and Immunology, Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30366-4']
2231,32534724,The Effectiveness of a Time Management Workshop on Job Stress of Nurses Working in Emergency Departments: An Experimental Study.,"INTRODUCTION


One of the main risk factors for poor health is a high level of job stress. Time management skills can greatly reduce job stress. The current study aimed to evaluate the effectiveness of a one-time management training workshop on job stress among nurses working in emergency departments.
METHODS


This randomized experimental study was carried out with 80 nurses working in emergency departments affiliated with a university of medical sciences. The intervention was an 8-hour workshop on time management. Pre- and posttest data were collected by demographic questionnaire and an occupational stress inventory before and 1 month after intervention. Data were analyzed using descriptive, chi-square, t test, Fisher exact, and analysis of covariance statistics.
RESULTS


The mean of job stress in the intervention group increased after the intervention (186.22, SD = 22.97) from baseline (182.52, SD = 34.39) compared with the mean of job stress in the control group (204.42, SD = 22.42) and (204.35, SD = 22.45). The control group had a significantly higher job stress score before the intervention (t = -3.37, P = 0.001). There was no statistically significant difference between the intervention and control group in job stress scores after intervention (t = -3.56, P = 0.77).
DISCUSSION


The time management skills training program did not reduce the moderate-high levels of job stress of nurses in emergency departments. Addressing other sources of job stress, besides time management, is needed.",2020,"There was no statistically significant difference between the intervention and control group in job stress scores after intervention (t = -3.56, P = 0.77).
","['80 nurses working in emergency departments affiliated with a university of medical sciences', 'nurses working in emergency departments', 'Job Stress of Nurses Working in Emergency Departments']","['one-time management training workshop', 'Time Management Workshop']","['job stress score', 'job stress scores', 'job stress', 'mean of job stress', 'moderate-high levels of job stress']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}]","[{'cui': 'C0556514', 'cui_str': 'Time management training'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0206209', 'cui_str': 'Time Management'}]","[{'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",80.0,0.0212648,"There was no statistically significant difference between the intervention and control group in job stress scores after intervention (t = -3.56, P = 0.77).
","[{'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Karbakhsh Ravari', 'Affiliation': ''}, {'ForeName': 'Jamileh', 'Initials': 'J', 'LastName': 'Farokhzadian', 'Affiliation': ''}, {'ForeName': 'Monirsadat', 'Initials': 'M', 'LastName': 'Nematollahi', 'Affiliation': ''}, {'ForeName': 'Sakineh', 'Initials': 'S', 'LastName': 'Miri', 'Affiliation': ''}, {'ForeName': 'Golnaz', 'Initials': 'G', 'LastName': 'Foroughameri', 'Affiliation': ''}]",Journal of emergency nursing,['10.1016/j.jen.2020.03.013']
2232,32534731,[Pulse pressure variation guided fluid therapy during kidney transplantation: a randomized controlled trial].,"PURPOSE


Kidney transplantation is the gold-standard treatment for end stage renal disease. Although different hemodynamic variables, like central venous pressure and mean arterial pressure, have been used to guide volume replacement during surgery, the best strategy still ought to be determined. Respiratory arterial Pulse Pressure Variation (PPV) is recognized to be a good predictor of fluid responsiveness for perioperative hemodynamic optimization in operating room settings. The aim of this study was to investigate whether a PPV-guided fluid management strategy is better than a liberal fluid strategy during kidney transplantation surgeries. Identification of differences in urine output in the first postoperative hour was the main objective of this study.
METHODS


We conducted a prospective, single blind, randomized controlled trial. We enrolled 40 patients who underwent kidney transplantation from deceased donors. Patients randomized in the PPV Group received fluids whenever PPV was higher than 12%, patients in the Free Fluid Group received fluids following our institutional standard care protocol for kidney transplantations (10mL.kg -1 .h -1 ).
RESULTS


Urinary output was similar at every time-point between the two groups, urea was statistically different from the third postoperative day with a peak at the fourth postoperative day and creatinine showed a similar trend, being statistically different from the second postoperative day. Urea, creatinine and urine output were not different at the hospital discharge.
CONCLUSION


PPV-guided fluid therapy during kidney transplantation significantly improves urea and creatinine levels in the first week after kidney transplantation surgery.",2020,"RESULTS


Urinary output was similar at every time-point between the two groups, urea was statistically different from the third postoperative day with a peak at the fourth postoperative day and creatinine showed a similar trend, being statistically different from the second postoperative day.","['40 patients who underwent kidney transplantation from deceased donors', 'kidney transplantation surgeries', 'kidney transplantation']","['Pulse pressure variation guided fluid therapy', 'PPV', 'PPV-guided fluid management strategy']","['Urinary output', 'Urea, creatinine and urine output', 'urea and creatinine levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}, {'cui': 'C0553741', 'cui_str': 'Fluid balance regulation'}]","[{'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0201975', 'cui_str': 'Creatinine measurement'}]",40.0,0.343157,"RESULTS


Urinary output was similar at every time-point between the two groups, urea was statistically different from the third postoperative day with a peak at the fourth postoperative day and creatinine showed a similar trend, being statistically different from the second postoperative day.","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'De Cassai', 'Affiliation': 'University of Padova, Department of Medicine - DIMED, Section of Anesthesiology and Intensive Care, Padova, Itália. Electronic address: alessandro.decassai@gmail.com.'}, {'ForeName': 'Ottavia', 'Initials': 'O', 'LastName': 'Bond', 'Affiliation': 'University of Padova, Department of Medicine - DIMED, Section of Anesthesiology and Intensive Care, Padova, Itália.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Marini', 'Affiliation': 'University of Padova, Department of Medicine - DIMED, Section of Anesthesiology and Intensive Care, Padova, Itália.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Panciera', 'Affiliation': 'University of Padova, Department of Medicine - DIMED, Section of Anesthesiology and Intensive Care, Padova, Itália.'}, {'ForeName': 'Lucrezia', 'Initials': 'L', 'LastName': 'Furian', 'Affiliation': 'Padua University Hospital, Department of Surgery, Oncology and Gastroenterology, Kidney and Pancreas Transplant Unit, Pádua, Itália.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Neri', 'Affiliation': 'Padua University Hospital, Department of Surgery, Oncology and Gastroenterology, Kidney and Pancreas Transplant Unit, Pádua, Itália.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Andreatta', 'Affiliation': 'University of Padova, Department of Medicine - DIMED, Section of Anesthesiology and Intensive Care, Padova, Itália.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Rigotti', 'Affiliation': 'Padua University Hospital, Department of Surgery, Oncology and Gastroenterology, Kidney and Pancreas Transplant Unit, Pádua, Itália.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Feltracco', 'Affiliation': 'University of Padova, Department of Medicine - DIMED, Section of Anesthesiology and Intensive Care, Padova, Itália.'}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2020.02.008']
2233,31771410,Does telerehabilitation result in inferior clinical outcomes compared with in-person care for the management of chronic musculoskeletal spinal conditions in the tertiary hospital setting? A non-randomised pilot clinical trial.,"INTRODUCTION


Clinical guidelines recommend multidisciplinary non-surgical management for most musculoskeletal spinal conditions. Access to such services continues to be a barrier for many individuals residing outside metropolitan regions. The primary aim of this study was to determine whether clinical outcomes achieved via telerehabilitation are as good as those achieved via in-person care.
METHODS


A non-randomised pilot clinical trial was undertaken where eligible patients chose to access treatment either via telerehabilitation or in-person (control group). Outcome measures for pain-related disability, pain severity and health-related quality of life were recorded at baseline, 3-, 6- and 9-months. Secondary outcomes included patient satisfaction and technical disruptions.
RESULTS


Seventy-one patients were recruited (telerehabilitation,  n  = 51; control group,  n  = 20). Patient characteristics did not differ at baseline and clinically meaningful improvements for pain-related disability and health-related quality of life were observed in both groups. Non-inferiority of telerehabilitation could not be claimed for any clinical outcome measure. There were no significant group-by-time interactions observed for either pain-related disability ( p  = 0.706), pain severity ( p  = 0.187) or health-related quality of life ( p  = 0.425) measures. The telerehabilitation group reported significantly higher levels of treatment satisfaction (median: 97 vs. 76.5;  p  = 0.021); 7.9% of telerehabilitation appointments were not completed due to technical disruptions.
DISCUSSION


Findings indicate patients with chronic musculoskeletal spinal conditions can achieve clinically meaningful improvements in their condition when accessing care via telerehabilitation. Telerehabilitation should be considered for individuals unable to access relevant in-person services; however non-inferiority remains inconclusive and requires further exploration.",2019,Patient characteristics did not differ at baseline and clinically meaningful improvements for pain-related disability and health-related quality of life were observed in both groups.,"['eligible patients chose to access treatment either via telerehabilitation or in-person (control group', 'Seventy-one patients were recruited (telerehabilitation,  n \u2009=\u200951; control group,  n \u2009=\u200920', 'patients with chronic musculoskeletal spinal conditions']",[],"['health-related quality of life', 'pain-related disability and health-related quality of life', 'patient satisfaction and technical disruptions', 'levels of treatment satisfaction', 'pain severity', 'pain-related disability, pain severity and health-related quality of life', 'pain-related disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",[],"[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",71.0,0.266307,Patient characteristics did not differ at baseline and clinically meaningful improvements for pain-related disability and health-related quality of life were observed in both groups.,"[{'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Cottrell', 'Affiliation': 'School of Health & Rehabilitation Sciences, University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Shaun P', 'Initials': 'SP', 'LastName': ""O'Leary"", 'Affiliation': 'School of Health & Rehabilitation Sciences, University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Maree', 'Initials': 'M', 'LastName': 'Raymer', 'Affiliation': ""Statewide Neurosurgical and Orthopaedic Physiotherapy Screening Clinic & Multidisciplinary Service, Royal Brisbane & Women's Hospital, Herston, Queensland, Australia.""}, {'ForeName': 'Anne J', 'Initials': 'AJ', 'LastName': 'Hill', 'Affiliation': 'School of Health & Rehabilitation Sciences, University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Comans', 'Affiliation': 'Centre for Health Services Research, University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Trevor G', 'Initials': 'TG', 'LastName': 'Russell', 'Affiliation': 'School of Health & Rehabilitation Sciences, University of Queensland, St Lucia, Queensland, Australia.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19887265']
2234,32525955,Simulation-based training using a vessel phantom effectively improved first attempt success and dynamic needle-tip positioning ability for ultrasound-guided radial artery cannulation in real patients: An assessor-blinded randomized controlled study.,"BACKGROUND


We evaluated whether a simulation-based training with a vessel phantom improves the basic skills of a novice required for ultrasound-guided radial artery cannulation in real patients. In addition, we analysed whether repeated simulation training sets with an inter-training interval would accelerate the learning curve.
METHODS


From March 2019 to July 2019, twenty-one anesthesiology residents were randomized into either a simulation group (n = 11) or control group (n = 10). Residents performed a total of 84 ultrasound-guided radial artery cannulations in real patients. The simulation group participated in two sets of simulation training on a vessel phantom (10 sessions per set) with a one-month inter-training interval. Trainee's performance proficiency was scored using a developed checklist, and a learning curve for each training set was constructed. To evaluate the effectiveness of our training curriculum in skill transfer, each resident performed four ultrasound-guided radial artery cannulations in real patients. The primary outcome was first attempt success rate and the secondary outcome was dynamic needle-tip positioning ability in real patients.
RESULTS


The first attempt success rate and dynamic needle-tip positioning ability by ultrasound transducer were significantly higher in the simulation group than the control group (81.8% vs. 50%, P = 0.002 and 68.2% vs. 7.5%, P < 0.001, respectively). A reduced number of sessions was required to reach a plateau score on the learning curve in the repeated training set compared in the first-set (7 (5-8) vs. 3 (2-4), P = 0.003, respectively).
CONCLUSIONS


Simulation-based training using a vessel phantom effectively improved the first attempt success rate for ultrasound-guided radial artery cannulation in real patients and the dynamic needle-tip positioning ability by ultrasound transducer in novice anesthesiology residents. In addition, repeated training curriculum accelerated the learning curve for recall skill proficiency and reduced inter-individual variability for skill acquisition.
CLINICAL TRIAL REGISTRATION


Clinical Research Information Service (KCT0003471, Principle investigator: Jeong Jin Min, Date of registration: 06/March/2019).",2020,"The first attempt success rate and dynamic needle-tip positioning ability by ultrasound transducer were significantly higher in the simulation group than the control group (81.8% vs. 50%, P = 0.002 and 68.2% vs. 7.5%, P < 0.001, respectively).","['From March 2019 to July 2019, twenty-one anesthesiology residents', 'real patients']","['simulation training on a vessel phantom (10 sessions per set) with a one-month inter-training interval', '84 ultrasound-guided radial artery cannulations', 'ultrasound-guided radial artery cannulation']","['success rate and the secondary outcome was dynamic needle-tip positioning ability in real patients', 'success rate and dynamic needle-tip positioning ability by ultrasound transducer']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0282611', 'cui_str': 'Phantom'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0040661', 'cui_str': 'Transducer'}]",,0.0489383,"The first attempt success rate and dynamic needle-tip positioning ability by ultrasound transducer were significantly higher in the simulation group than the control group (81.8% vs. 50%, P = 0.002 and 68.2% vs. 7.5%, P < 0.001, respectively).","[{'ForeName': 'Eun Jung', 'Initials': 'EJ', 'LastName': 'Oh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jong-Hwan', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea.'}, {'ForeName': 'Eun Jin', 'Initials': 'EJ', 'LastName': 'Kwon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jeong Jin', 'Initials': 'JJ', 'LastName': 'Min', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea.'}]",PloS one,['10.1371/journal.pone.0234567']
2235,32526225,The effect of HF-rTMS over the left DLPFC on stress regulation as measured by cortisol and heart rate variability.,"The prefrontal cortex, and especially the Dorsolateral Prefrontal Cortex (DLPFC), plays an inhibitory role in the regulation of the Hypothalamic-Pituitary-Adrenal (HPA) axis under stressful situations. Moreover, recent evidence suggests that a sustained DLPFC activation is associated with adaptive stress regulation in anticipation of a stressful event, leading to a reduced stress-induced amygdala response, and facilitating the confrontation with the stressor. However, studies using experimental manipulation of the activity of the DLPFC before a stressor are scarce, and more research is needed to understand the specific role of this brain area in the stress-induced physiological response. This pre-registered study investigated the effect on stress regulation of a single excitatory high frequency (versus sham) repetitive transcranial magnetic stimulation (HF-rTMS) session over the left DLPFC applied before the Trier Social Stress Test in 75 healthy young women (M = 21.05, SD = 2.60). Heart rate variability (HRV) and salivary cortisol were assessed throughout the experimental protocol. The active HF-rTMS and the sham group showed a similar cognitive appraisal of the stress task. No differences in HRV were observed during both the anticipation and the actual confrontation with the stress task and therefore, our results did not reflect DLPFC-related adaptive anticipatory adjustments. Importantly, participants in the active HF-rTMS group showed a lower cortisol response to stress. The effect of left prefrontal HF-rTMS on the stress system provides further critical experimental evidence for the inhibitory role played by the DLPFC in the regulation of the HPA axis.",2020,"No differences in HRV were observed during both the anticipation and the actual confrontation with the stress task and therefore, our results did not reflect DLPFC-related adaptive anticipatory adjustments.","['75 healthy young women (M\u202f=\u202f21.05, SD\u202f=\u202f2.60']","['single excitatory high frequency (versus sham) repetitive transcranial magnetic stimulation (HF-rTMS) session', 'HF-rTMS']","['HRV', 'cortisol response', 'Heart rate variability (HRV) and salivary cortisol']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}]",75.0,0.0262171,"No differences in HRV were observed during both the anticipation and the actual confrontation with the stress task and therefore, our results did not reflect DLPFC-related adaptive anticipatory adjustments.","[{'ForeName': 'Matias M', 'Initials': 'MM', 'LastName': 'Pulopulos', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium. Electronic address: matias.pulopulos@ugent.be.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Schmausser', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'De Smet', 'Affiliation': 'Department of Head and Skin, Ghent University, Belgium; Ghent Experimental Psychiatry (GHEP) Lab, Belgium.'}, {'ForeName': 'Marie-Anne', 'Initials': 'MA', 'LastName': 'Vanderhasselt', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium; Department of Head and Skin, Ghent University, Belgium; Ghent Experimental Psychiatry (GHEP) Lab, Belgium.'}, {'ForeName': 'Shishir', 'Initials': 'S', 'LastName': 'Baliyan', 'Affiliation': 'Department of Psychobiology, Universidad Nacional de Educación a Distancia (UNED), Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Venero', 'Affiliation': 'Department of Psychobiology, Universidad Nacional de Educación a Distancia (UNED), Spain.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Baeken', 'Affiliation': 'Department of Head and Skin, Ghent University, Belgium; Ghent Experimental Psychiatry (GHEP) Lab, Belgium; Department of Psychiatry, University Hospital Brussels (UZBrussel), Belgium; Department of Electrical Engineering, Eindhoven University of Technology, the Netherlands.'}, {'ForeName': 'Rudi', 'Initials': 'R', 'LastName': 'De Raedt', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium.'}]",Hormones and behavior,['10.1016/j.yhbeh.2020.104803']
2236,32526634,"Randomised phase II study of panitumumab plus irinotecan versus cetuximab plus irinotecan in patients with KRAS wild-type metastatic colorectal cancer refractory to fluoropyrimidine, irinotecan and oxaliplatin (WJOG 6510G).","BACKGROUND


Cetuximab has been shown to be clinically active when given in combination with irinotecan in patients with irinotecan-refractory metastatic colorectal cancer (mCRC). However, it has remained unclear whether panitumumab is effective when combined with irinotecan. We compared efficacies of both regimens in this randomised phase II study.
PATIENTS AND METHODS


Patients with wild-type KRAS exon 2 mCRC previously treated with fluorouracil-, oxaliplatin- and irinotecan-based chemotherapies were randomised (1:1) to either panitumumab plus irinotecan (panitumumab arm) or cetuximab plus irinotecan (cetuximab arm). The primary end-point was progression-free survival (PFS). The planned sample size was 120, expecting a hazard ratio (HR) of 1.0 with non-inferiority margin of 1.3 (one-sided alpha error 0.2 and power 0.7). Major secondary end-points were overall survival (OS), response rate and safety.
RESULTS


From December 2011 to September 2014, 121 patients were enrolled, and 61 and 59 patients were randomised to the panitumumab and cetuximab arms, respectively (1 patient excluded). Most patients (97%) had received prior chemotherapies containing bevacizumab. The median PFS was 5.42 months in the panitumumab arm and 4.27 months in the cetuximab arm (HR = 0.64, 95% confidence interval [CI] = 0.44-0.94, P < 0.001 for non-inferiority, P = 0.058 for superiority), and median OS was 14.85 and 11.53 months (HR = 0.66, 95% CI = 0.44-1.00, P = 0.050 for superiority), respectively. The incidence of grade 3 or 4 hypomagnesaemia was higher in the panitumumab arm than that in the cetuximab arm (17% vs. 7%).
CONCLUSION


Panitumumab may be non-inferior to cetuximab in combination with irinotecan in survival of patients with irinotecan-refractory mCRC.",2020,"CONCLUSION


Panitumumab may be non-inferior to cetuximab in combination with irinotecan in survival of patients with irinotecan-refractory mCRC.","['patients with KRAS wild-type metastatic colorectal cancer refractory to', 'patients with irinotecan-refractory metastatic colorectal cancer (mCRC', 'From December 2011 to September 2014', 'patients with irinotecan-refractory mCRC', '121 patients were enrolled, and 61 and 59 patients', 'Patients with wild-type KRAS exon 2 mCRC previously treated with']","['panitumumab plus irinotecan versus cetuximab plus irinotecan', 'fluoropyrimidine, irinotecan\xa0and oxaliplatin (WJOG 6510G', 'panitumumab', 'panitumumab and cetuximab', 'panitumumab plus irinotecan (panitumumab arm) or cetuximab plus irinotecan (cetuximab arm', 'irinotecan', 'bevacizumab', 'fluorouracil-, oxaliplatin-\xa0and irinotecan-based chemotherapies']","['median OS', 'incidence of grade 3 or 4 hypomagnesaemia', 'overall survival (OS), response rate\xa0and safety', 'progression-free survival (PFS', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0151723', 'cui_str': 'Hypomagnesemia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",121.0,0.220477,"CONCLUSION


Panitumumab may be non-inferior to cetuximab in combination with irinotecan in survival of patients with irinotecan-refractory mCRC.","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sakai', 'Affiliation': 'Department of Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Suita, Japan. Electronic address: dsakai@cfs.med.osaka-u.ac.jp.'}, {'ForeName': 'Hiroya', 'Initials': 'H', 'LastName': 'Taniguchi', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Naotoshi', 'Initials': 'N', 'LastName': 'Sugimoto', 'Affiliation': 'Department of Medical Oncology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Tamura', 'Affiliation': 'Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Nishina', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Gastroenterology, Saitama Cancer Center, Saitama, Japan.'}, {'ForeName': 'Taito', 'Initials': 'T', 'LastName': 'Esaki', 'Affiliation': 'Department of Gastrointestinal and Medical Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Tadamichi', 'Initials': 'T', 'LastName': 'Denda', 'Affiliation': 'Division of Gastroenterology, Chiba Cancer Center, Chiba, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Gastroetererological Oncology, Hyogo Cancer Center, Akashi, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Okuda', 'Affiliation': 'Department of Medical Oncology, Keiyukai Sapporo Hospital, Sapporo, Japan.'}, {'ForeName': 'Taroh', 'Initials': 'T', 'LastName': 'Satoh', 'Affiliation': 'Department of Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Tsushima', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Akitaka', 'Initials': 'A', 'LastName': 'Makiyama', 'Affiliation': 'Department of Hematology/Oncology, Japan Community Healthcare Organization Kyushu Hospital, Fukuoka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Tsuda', 'Affiliation': 'Department of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan.'}, {'ForeName': 'Ayumu', 'Initials': 'A', 'LastName': 'Hosokawa', 'Affiliation': 'Department of Gastroenterology and Hematology, Faculty of Medicine, University of Toyama, Toyama, Japan.'}, {'ForeName': 'Hidekazu', 'Initials': 'H', 'LastName': 'Kuramochi', 'Affiliation': ""Department of Chemotherapy, Tokyo Women's Medical University, Yachiyo Medical Center, Yachiyo, Japan.""}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Tokunaga', 'Affiliation': 'Department of Medical Oncology, Osaka City General Hospital, Osaka, Japan.'}, {'ForeName': 'Toshikazu', 'Initials': 'T', 'LastName': 'Moriwaki', 'Affiliation': 'Division of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Hisateru', 'Initials': 'H', 'LastName': 'Yasui', 'Affiliation': 'Department of Medical Oncology, Kobe City Medical Center General Hospital, Kobe, Japan.'}, {'ForeName': 'Hiroyasu', 'Initials': 'H', 'LastName': 'Ishida', 'Affiliation': 'Department of Gastroenterology, National Hospital Organization Mito Medical Center, Mito, Japan.'}, {'ForeName': 'Akihito', 'Initials': 'A', 'LastName': 'Tsuji', 'Affiliation': 'Department of Clinical Oncology, Kagawa University Faculty of Medicine, Kagawa, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Otsu', 'Affiliation': 'Department of Medical Oncology and Hematology, Oita University Faculty of Medicine, Oita, Japan.'}, {'ForeName': 'Hozumi', 'Initials': 'H', 'LastName': 'Shimokawa', 'Affiliation': 'Department of Medical Oncology, Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Japan.'}, {'ForeName': 'Eishi', 'Initials': 'E', 'LastName': 'Baba', 'Affiliation': 'Department of Oncology and Social Medicine, Graduate School of Medical Sciences, Kyushu University, Japan.'}, {'ForeName': 'Mikio', 'Initials': 'M', 'LastName': 'Sato', 'Affiliation': 'Department of Gastroenterology and Hepatology, Ryugasaki Saiseikai Hospital, Ryugasaki, Japan.'}, {'ForeName': 'Shigemi', 'Initials': 'S', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Medical Oncology, Kyoto University Hospital, Kyoto, Japan.'}, {'ForeName': 'Yukinori', 'Initials': 'Y', 'LastName': 'Ozaki', 'Affiliation': 'Department of Medical Oncology, Toranomon Hospital, Tokyo, Japan.'}, {'ForeName': 'Katsunori', 'Initials': 'K', 'LastName': 'Shinozaki', 'Affiliation': 'Division of Clinical Oncology, Hiroshima Prefectural Hospital, Hiroshima, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Tamagawa', 'Affiliation': 'Department of Surgery, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Goto', 'Affiliation': 'Cancer Chemotherapy Center, Osaka Medical College, Osaka, Japan.'}, {'ForeName': 'Shigenori', 'Initials': 'S', 'LastName': 'Kadowaki', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Fujii', 'Affiliation': 'Department of Clinical Oncology, Jichi Medical University Hospital, Tochigi, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Koh', 'Affiliation': 'Internal Medicine III, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Yamazaki', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Hironaka', 'Affiliation': 'Department of Medical Oncology and Hematology, Oita University Faculty of Medicine, Oita, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Kishimoto', 'Affiliation': 'Center for Clinical and Translational Research, Kyushu University Hospital, Japan.'}, {'ForeName': 'Narikazu', 'Initials': 'N', 'LastName': 'Boku', 'Affiliation': 'Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Ichinosuke', 'Initials': 'I', 'LastName': 'Hyodo', 'Affiliation': 'Division of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.04.014']
2237,32526669,A CT-based deep learning model for predicting the nuclear grade of clear cell renal cell carcinoma.,"PURPOSE


To investigate the effects of different methodologies on the performance of deep learning (DL) model for differentiating high- from low-grade clear cell renal cell carcinoma (ccRCC).
METHOD


Patients with pathologically proven ccRCC diagnosed between October 2009 and March 2019 were assigned to training or internal test dataset, and external test dataset was acquired from The Cancer Genome Atlas-Kidney Renal Clear Cell Carcinoma (TCGA-KIRC) database. The effects of different methodologies on the performance of DL-model, including image cropping (IC), setting the attention level, selecting model complexity (MC), and applying transfer learning (TL), were compared using repeated measures analysis of variance (ANOVA) and receiver operating characteristic (ROC) curve analysis. The performance of DL-model was evaluated through accuracy and ROC analyses with internal and external tests.
RESULTS


In this retrospective study, patients (n = 390) from one hospital were randomly assigned to training (n = 370) or internal test dataset (n = 20), and the other 20 patients from TCGA-KIRC database were assigned to external test dataset. IC, the attention level, MC, and TL had major effects on the performance of the DL-model. The DL-model based on the cropping of an image less than three times the tumor diameter, without attention, a simple model and the application of TL achieved the best performance in internal (ACC = 73.7 ± 11.6%, AUC = 0.82 ± 0.11) and external (ACC = 77.9 ± 6.2%, AUC = 0.81 ± 0.04) tests.
CONCLUSIONS


CT-based DL model can be conveniently applied for grading ccRCC with simple IC in routine clinical practice.",2020,"IC, the attention level, MC, and TL had major effects on the performance of the DL-model.","['Patients with pathologically proven ccRCC diagnosed between October 2009 and March 2019', 'differentiating high- from low-grade clear cell renal cell carcinoma (ccRCC', 'patients (n\u202f=\u202f390) from one hospital were randomly assigned to training (n\u202f=\u202f370) or internal test dataset (n\u202f=\u202f20), and the other 20 patients from TCGA-KIRC database']",['CT-based deep learning model'],"['performance of DL-model, including image cropping (IC), setting the attention level, selecting model complexity (MC), and applying transfer learning (TL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0279702', 'cui_str': 'Clear cell carcinoma of kidney'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0004170', 'cui_str': 'Bone structure of atlas'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C4760635', 'cui_str': 'Transfer Learning'}]",,0.0253668,"IC, the attention level, MC, and TL had major effects on the performance of the DL-model.","[{'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Lin', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Shenzhen University, Health Science Center, Shenzhen Second People's Hospital, 3002 SunGangXi Road, Shenzhen, 518035, China.""}, {'ForeName': 'Changyi', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Department of Radiology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Guangdong Medical University, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China.'}, {'ForeName': 'Jinpeng', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Radiology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Guangdong Medical University, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lei', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Shenzhen University, Health Science Center, Shenzhen Second People's Hospital, 3002 SunGangXi Road, Shenzhen, 518035, China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Pathology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Lan', 'Affiliation': 'Department of Radiology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Guangdong Medical University, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': 'Department of Urology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China.'}, {'ForeName': 'Wansheng', 'Initials': 'W', 'LastName': 'Long', 'Affiliation': 'Department of Radiology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Guangdong Medical University, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China.'}, {'ForeName': 'Enming', 'Initials': 'E', 'LastName': 'Cui', 'Affiliation': 'Department of Radiology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Guangdong Medical University, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China. Electronic address: cem2008@163.com.'}]",European journal of radiology,['10.1016/j.ejrad.2020.109079']
2238,32526771,Criteria for the determination of maximal oxygen uptake in patients newly diagnosed with cancer: Baseline data from the randomized controlled trial of physical training and cancer (Phys-Can).,"INTRODUCTION


Maximal oxygen uptake ([Formula: see text]) is a measure of cardiorespiratory fitness often used to monitor changes in fitness during and after treatment in cancer patients. There is, however, limited knowledge in how criteria verifying [Formula: see text] work for patients newly diagnosed with cancer. Therefore, the aim of this study was to describe the prevalence of fulfillment of typical criteria verifying [Formula: see text] and to investigate the associations between the criteria and the test leader's evaluation whether a test was performed ""to exhaustion"". An additional aim was to establish new cut-points within the associated criteria.
METHODS


From the Phys-Can randomized controlled trial, 535 patients (59 ±12 years) newly diagnosed with breast (79%), prostate (17%) or colorectal cancer (4%) performed an incremental [Formula: see text] test on a treadmill. The test was performed before starting (neo-)adjuvant treatment and an exercise intervention. Fulfillment of different cut-points within typical criteria verifying [Formula: see text] was described. The dependent key variables included in the initial bivariate analysis were achievement of a [Formula: see text] plateau, peak values for maximal heart rate, respiratory exchange ratio (RER), the patients' rating of perceived exertion on Borg's scale6-20 and peak breathing frequency (fR). A receiver operating characteristic analysis was performed to establish cut-points for variables associated with the test leader's evaluation. Last, a cross-validation of the cut-points found in the receiver operating characteristic analysis was performed on a comparable sample of cancer patients (n = 80).
RESULTS


The criteria RERpeak (<0.001), Borg's RPE (<0.001) and fR peak (p = 0.018) were associated with the test leader's evaluation of whether a test was defined as ""to exhaustion"". The cut-points that best predicted the test leader's evaluation were RER ≥ 1.14, RPE ≥ 18 and fR ≥ 40. Maximal heart rate and [Formula: see text] plateau was not associated with the test leader's evaluation.
CONCLUSION


We recommend a focus on RER (in the range between ≥1.1 and ≥1.15) and RPE (≥17 or ≥18) in addition to the test leader's evaluation. Additionally, a fR peak of ≥40 breaths/min may be a cut-point to help the test leader evaluate the degree of exhaustion. However, more research is needed to verify our findings, and to investigate how these criteria will work within a population that are undergoing or finished with cancer treatment.",2020,"The criteria RERpeak (<0.001), Borg's RPE (<0.001) and fR peak (p = 0.018) were associated with the test leader's evaluation of whether a test was defined as ""to exhaustion"".","['535 patients (59 ±12 years) newly diagnosed with breast (79%), prostate (17%) or colorectal cancer (4%) performed an', 'cancer patients', 'patients newly diagnosed with cancer']","['incremental [Formula: see text] test on a treadmill', 'physical training and cancer (Phys-Can']","[""achievement of a [Formula: see text] plateau, peak values for maximal heart rate, respiratory exchange ratio (RER), the patients' rating of perceived exertion on Borg's scale6-20 and peak breathing frequency (fR"", 'fR peak', 'Maximal heart rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",535.0,0.0740939,"The criteria RERpeak (<0.001), Borg's RPE (<0.001) and fR peak (p = 0.018) were associated with the test leader's evaluation of whether a test was defined as ""to exhaustion"".","[{'ForeName': 'Ann Christin Helgesen', 'Initials': 'ACH', 'LastName': 'Bjørke', 'Affiliation': 'Department of Sport Science and Physical Education, University of Agder, Kristiansand, Norway.'}, {'ForeName': 'Truls', 'Initials': 'T', 'LastName': 'Raastad', 'Affiliation': 'Department of Sport Science and Physical Education, University of Agder, Kristiansand, Norway.'}, {'ForeName': 'Sveinung', 'Initials': 'S', 'LastName': 'Berntsen', 'Affiliation': 'Department of Sport Science and Physical Education, University of Agder, Kristiansand, Norway.'}]",PloS one,['10.1371/journal.pone.0234507']
2239,32527221,The effect of 10-min dispatch-assisted cardiopulmonary resuscitation training: a randomized simulation pilot study.,"BACKGROUND


Immediate bystander cardiopulmonary resuscitation (CPR) is essential for survival from sudden cardiac arrest (CA). Current CPR guidelines recommend that dispatchers assist lay rescuers performing CPR (dispatch-assisted CPR (DACPR)), which can double the frequency of bystander CPR. Laypersons, however, are not familiar with receiving CPR instructions from dispatchers. DACPR training can be beneficial for lay rescuers, but this has not yet been validated. The aim of this study was to determine the effectiveness of simple DACPR training for lay rescuers.
METHODS


We conducted a DACPR simulation pilot study. Participants who were non-health care professionals with no CPR training within 1 year prior to this study were recruited from Nara Medical University Hospital. The participants were randomly assigned to one of the two 90-min adult basic life support (BLS) training course groups: DACPR group (standard adult BLS training plus an additional 10-min DACPR training) or Standard group (standard adult BLS training only). In the DACPR group, participants practiced DACPR through role-playing of a dispatcher and an emergency caller. Six months after the training, all subjects were asked to perform a 2-min CPR simulation under instructions given by off-duty dispatchers.
RESULTS


Out of the 66 participants, 59 completed the simulation (30 from the DACPR group and 29 from the Standard group). The CPR quality was similar between the two groups. However, the median time interval between call receipt and the first dispatch-assisted compression was faster in the DACPR group (108 s vs 129 s, p = 0.042).
CONCLUSIONS


This brief DACPR training in addition to standard CPR training can result in a modest improvement in the time to initiate CPR. Future studies are now required to examine the effect of DACPR training on survival of sudden CA.",2020,"However, the median time interval between call receipt and the first dispatch-assisted compression was faster in the DACPR group (108 s vs 129 s, p = 0.042).
","['66 participants, 59 completed the simulation (30 from the DACPR group and 29 from the Standard group', 'Participants who were non-health care professionals with no CPR training within 1 year prior to this study were recruited from Nara Medical University Hospital']","['10-min dispatch-assisted cardiopulmonary resuscitation training', 'DACPR', 'standard CPR training', 'DACPR training', 'bystander cardiopulmonary resuscitation (CPR', '90-min adult basic life support (BLS) training course groups: DACPR group (standard adult BLS training plus an additional 10-min DACPR training) or Standard group (standard adult BLS training only', 'simple DACPR training']","['median time interval between call receipt and the first dispatch-assisted compression', 'CPR quality']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0085873', 'cui_str': 'Basic life support'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205352', 'cui_str': 'Simple'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",,0.0642676,"However, the median time interval between call receipt and the first dispatch-assisted compression was faster in the DACPR group (108 s vs 129 s, p = 0.042).
","[{'ForeName': 'Hidetada', 'Initials': 'H', 'LastName': 'Fukushima', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Nara Medical University, Shijo-cho 840, Kashihara City, Nara, 634-8522, Japan. hidetakarina@gmail.com.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Asai', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Nara Medical University, Shijo-cho 840, Kashihara City, Nara, 634-8522, Japan.'}, {'ForeName': 'Tadahiko', 'Initials': 'T', 'LastName': 'Seki', 'Affiliation': 'Department of Emergency, Nara Prefecture General Medical Center, Shichijo-Nishimachi 2-897-5, Nara City, 630-8581, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Takano', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Nara Medical University, Shijo-cho 840, Kashihara City, Nara, 634-8522, Japan.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bolstad', 'Affiliation': 'Clinical English, Nara Medical University, Shijo-cho 840, Kashihara City, Nara, 634-8522, Japan.'}]",International journal of emergency medicine,['10.1186/s12245-020-00287-9']
2240,32527232,Safety and efficacy of glibenclamide combined with rtPA in acute cerebral ischemia with occlusion/stenosis of anterior circulation (SE-GRACE): study protocol for a randomized controlled trial.,"BACKGROUND


Thrombolysis with recombinant tissue plasminogen activator (rtPA) improves outcome for patients with acute ischemic stroke (AIS), but many of them still have substantial disability. Glibenclamide (US adopted name, glyburide), a long-acting sulfonylurea, shows promising result in treating AIS from both preclinical and clinical studies. This study investigates the safety and efficacy of glibenclamide combined with rtPA in treating AIS patients.
METHODS


This is a prospective, randomized, double-blind, placebo-controlled, multicenter trial with an estimated sample size of 306 cases, starting in January 2018. Patients aged 18 to 74 years, presented with a symptomatic anterior circulation occlusion with a deficit on the NIHSS of 4 to 25 points and treated with intravenous rtPA within the first 4.5 h of their clinical onsets, are eligible for participation in this study. The target time from the onset of symptoms to receive the study drug is of 10 h. Subjects are randomized 1: 1 to receive glibenclamide or placebo with a loading dose of 1.25 mg, followed by 0.625 mg every 8 h for total 5 days. The primary efficacy endpoint is 90-day good outcome, measured as modified Rankin Scale of 0 to 2. Safety outcomes are all-cause 30-day mortality and early neurological deterioration, with a focus on cardiac- and glucose-related serious adverse events.
DISCUSSION


This study will provide valuable information about the safety and efficacy of oral glibenclamide for AIS patients treated with rtPA. This would bring benefits to a large number of patients if the agent is proved to be effective.
TRIAL REGISTRATION


The trial was registered on September 14th 2017 at www.clinicaltrials.gov having identifier NCT03284463. Registration was performed before recruitment was initiated.",2020,"BACKGROUND


Thrombolysis with recombinant tissue plasminogen activator (rtPA) improves outcome for patients with acute ischemic stroke (AIS), but many of them still have substantial disability.","['Patients aged 18 to 74\u2009years, presented with a symptomatic anterior circulation occlusion with a deficit on the NIHSS of 4 to 25 points and treated with intravenous rtPA within the first 4.5\u2009h of their clinical onsets, are eligible for participation in this study', 'AIS patients treated with rtPA', 'multicenter trial with an estimated sample size of 306 cases, starting in January 2018', 'patients with acute ischemic stroke (AIS', 'acute cerebral ischemia with occlusion/stenosis of anterior circulation (SE-GRACE']","['glibenclamide combined with rtPA', 'Glibenclamide (US adopted name, glyburide', 'glibenclamide or placebo', 'recombinant tissue plasminogen activator (rtPA', 'glibenclamide', 'placebo']","['30-day mortality and early neurological deterioration', 'modified Rankin Scale of 0 to 2', 'safety and efficacy', 'Safety and efficacy', 'cardiac- and glucose-related serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0206012', 'cui_str': 'Multicentre Trials'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C2215101', 'cui_str': 'Acute cerebral ischemia'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}]","[{'cui': 'C0017628', 'cui_str': 'Glyburide'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C1549653', 'cui_str': 'Adopted name'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.247589,"BACKGROUND


Thrombolysis with recombinant tissue plasminogen activator (rtPA) improves outcome for patients with acute ischemic stroke (AIS), but many of them still have substantial disability.","[{'ForeName': 'Kaibin', 'Initials': 'K', 'LastName': 'Huang', 'Affiliation': 'Department of Neurology, Nanfang Hospital, Southern Medical University, Guangzhou North Avenue 1838#, Guangzhou, 510515, China.'}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Ji', 'Affiliation': 'Department of Neurology, Nanfang Hospital, Southern Medical University, Guangzhou North Avenue 1838#, Guangzhou, 510515, China.'}, {'ForeName': 'Yongming', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, Nanfang Hospital, Southern Medical University, Guangzhou North Avenue 1838#, Guangzhou, 510515, China.'}, {'ForeName': 'Yunqiang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ""Department of Neurology, Heyuan People's Hospital, Heyuan, China.""}, {'ForeName': 'Guangning', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': ""Department of Neurology, Huadu district People's Hospital, Guangzhou, China.""}, {'ForeName': 'Saijun', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': ""Department of Neurology, Maoming People's Hospital, Maoming, China.""}, {'ForeName': 'Wenguo', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'Department of Neurology, Maoming Hospital of Traditional Chinese Medicine, Maoming, China.'}, {'ForeName': 'Guoshuai', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': ""Department of Neurology, Haikou People's Hospital, Haikou, China.""}, {'ForeName': 'Guohu', 'Initials': 'G', 'LastName': 'Weng', 'Affiliation': 'Department of Neurology, Hainan Hospital of Traditional Chinese Medicine, Haikou, China.'}, {'ForeName': 'Pingyan', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistics, School of Public Health, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Suyue', 'Initials': 'S', 'LastName': 'Pan', 'Affiliation': 'Department of Neurology, Nanfang Hospital, Southern Medical University, Guangzhou North Avenue 1838#, Guangzhou, 510515, China. pansuyue82@126.com.'}]",BMC neurology,['10.1186/s12883-020-01823-z']
2241,32527261,Social response to the delivery of HIV self-testing in households: experiences from four Zambian HPTN 071 (PopART) urban communities.,"BACKGROUND


Door-to-door distribution of HIV self-testing kits (HIVST) has the potential to increase uptake of HIV testing services (HTS). However, very few studies have explored the social response to and implications of door-to-door including secondary distribution of HIVST on household relations and the ability of individuals to self-test with or without supervision within households.
METHODS


A CRT of HIVST distribution was nested within the HPTN 071 (PopART) trial, in four Zambian communities randomised to receive the PopART intervention. The nested HIVST trial aimed to increase knowledge of HIV status at population level. Between February 1 and April 30, 2017, 66 zones (clusters) within these four communities were randomly allocated to either the PopART standard of care door-to-door HTS (33 clusters) or PopART standard of care door-to-door HTS plus oral HIVST (33 clusters). In clusters randomised to HIVST, trained Community HIV care provider (CHiPs) visited households and offered individuals aged ≥ 16 and eligible for an offer of HTS the choice of HIV testing using HIVST or routine door-to-door HTS (finger-prick RDT). To document participants' experiences with HIVST, Interviews (n = 40), observations (n = 22) and group discussions (n = 91) with household members and CHiPs were conducted. Data were coded using Atlas.ti 7 and analysed thematically.
RESULTS


The usage and storage of HIVST kits was facilitated by familiarity with and trust in CHiPs, the novelty of HIVST, and demonstrations and supervision provided by CHiPs. Door-to-door distribution of HIVST kits was appreciated for being novel, convenient, private, empowering, autonomous and easy-to-use. Literacy and age influenced accurate usage of HIVST kits. The novelty of using oral fluids to test for HIV raised questions, some anxiety and doubts about the accuracy of HIVST. Although HIVST protected participants from experiencing clinic-based stigma, it did not address self-stigma. Within households, HIVST usually strengthened relationships but, amongst couples, there were a few reports of social harms.
CONCLUSION


Door-to-door distribution of HIVST as a choice for how to HIV test is appreciated at community level and provides an important testing option in the sub-Saharan context. However, it should be accompanied by counselling to manage social harms and by supporting those testing HIV-positive to link to care.",2020,"The usage and storage of HIVST kits was facilitated by familiarity with and trust in CHiPs, the novelty of HIVST, and demonstrations and supervision provided by CHiPs.","[""participants' experiences with HIVST, Interviews (n\u2009=\u200940), observations (n\u2009=\u200922) and group discussions (n\u2009=\u200991) with household members and CHiPs were conducted"", ' trained Community HIV care provider (CHiPs) visited households and offered individuals aged\u2009≥\u200916 and eligible for an offer of HTS the choice of HIV testing using', 'households: experiences from four Zambian HPTN 071 (PopART) urban communities', 'Between February 1 and April 30, 2017, 66 zones (clusters) within these four communities']","['HIVST', 'PopART standard of care door-to-door HTS (33 clusters) or PopART standard of care door-to-door HTS plus oral HIVST', 'PopART intervention', 'HIV self-testing kits (HIVST', 'HIVST or routine door-to-door HTS (finger-prick RDT']",[],"[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0057856', 'cui_str': 'iproplatin'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0557698', 'cui_str': 'Door'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0206743', 'cui_str': 'Malignant rhabdoid tumor'}]",[],,0.0271676,"The usage and storage of HIVST kits was facilitated by familiarity with and trust in CHiPs, the novelty of HIVST, and demonstrations and supervision provided by CHiPs.","[{'ForeName': 'Chiti', 'Initials': 'C', 'LastName': 'Bwalya', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Lusaka, Zambia. Bwalya@zambart.org.zm.'}, {'ForeName': 'Musonda', 'Initials': 'M', 'LastName': 'Simwinga', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Hensen', 'Affiliation': 'Clinical Research Department, Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Lwiindi', 'Initials': 'L', 'LastName': 'Gwanu', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Able', 'Initials': 'A', 'LastName': ""Hang'andu"", 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Chama', 'Initials': 'C', 'LastName': 'Mulubwa', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Mwelwa', 'Initials': 'M', 'LastName': 'Phiri', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hayes', 'Affiliation': 'Department of Infectious Disease Epidemiology, Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Fidler', 'Affiliation': 'Imperial College, London, UK.'}, {'ForeName': 'Alwyn', 'Initials': 'A', 'LastName': 'Mwinga', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Ayles', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Bond', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Lusaka, Zambia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",AIDS research and therapy,['10.1186/s12981-020-00287-y']
2242,32527268,Neurophysiological signatures of hand motor response to dual-transcranial direct current stimulation in subacute stroke: a TMS and MEG study.,"BACKGROUND


Dual transcranial direct current stimulation (tDCS) to the bilateral primary motor cortices (M1s) has potential benefits in chronic stroke, but its effects in subacute stroke, when behavioural effects might be expected to be greater, have been relatively unexplored. Here, we examined the neurophysiological effects and the factors influencing responsiveness of dual-tDCS in subacute stroke survivors.
METHODS


We conducted a randomized sham-controlled crossover study in 18 survivors with first-ever, unilateral subcortical ischaemic stroke 2-4 weeks after stroke onset and 14 matched healthy controls. Participants had real dual-tDCS (with an ipsilesional [right for controls] M1 anode and a contralesional M1 [left for controls] cathode; 2 mA for 20mins) and sham dual-tDCS on separate days, with concurrent paretic [left for controls] hand exercise. Using transcranial magnetic stimulation (TMS) and magnetoencephalography (MEG), we recorded motor evoked potentials (MEPs), the ipsilateral silent period (iSP), short-interval intracortical inhibition, and finger movement-related cortical oscillations before and immediately after tDCS.
RESULTS


Stroke survivors had decreased excitability in ipsilesional M1 with a relatively excessive transcallosal inhibition from the contralesional to ipsilesional hemisphere at baseline compared with controls, as quantified by decreased MEPs and increased iSP duration. Dual-tDCS led to increased MEPs and decreased iSP duration in ipsilesional M1. The magnitude of the tDCS-induced MEP increase in stroke survivors was predicted by baseline contralesional-to-ipsilesional transcallosal inhibition (iSP) ratio. Baseline post-movement synchronization in α-band activity in ipsilesional M1 was decreased after stroke compared with controls, and its tDCS-induced increase correlated with upper limb score in stroke survivors. No significant adverse effects were observed during or after dual-tDCS.
CONCLUSIONS


Task-concurrent dual-tDCS in subacute stroke can safely and effectively modulate bilateral M1 excitability and inter-hemispheric imbalance and also movement-related α-activity.",2020,"Baseline post-movement synchronization in α-band activity in ipsilesional M1 was decreased after stroke compared with controls, and its tDCS-induced increase correlated with upper limb score in stroke survivors.","['subacute stroke survivors', '18 survivors with first-ever, unilateral subcortical ischaemic stroke 2-4\u2009weeks after stroke onset and 14 matched healthy controls', 'subacute stroke', 'Participants had real dual-tDCS (with an ipsilesional [right for controls] M1 anode and a contralesional M1 [left for controls] cathode; 2\u2009mA for 20mins) and']","['Dual transcranial direct current stimulation (tDCS', 'Task-concurrent dual-tDCS', 'transcranial magnetic stimulation (TMS) and magnetoencephalography (MEG', 'concurrent paretic [left for controls] hand exercise', 'dual-transcranial direct current stimulation', 'sham dual-tDCS']","['α-band activity in ipsilesional M1', 'stroke survivors', 'upper limb score', 'bilateral M1 excitability and inter-hemispheric imbalance', 'excitability in ipsilesional M1', 'adverse effects', 'motor evoked potentials (MEPs), the ipsilateral silent period (iSP), short-interval intracortical inhibition, and finger movement-related cortical oscillations', 'iSP duration']","[{'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0003103', 'cui_str': 'Anode'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0007441', 'cui_str': 'Cathode'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0024489', 'cui_str': 'Magnetoencephalography'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0454330', 'cui_str': 'Hand exercises'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205139', 'cui_str': 'Hemispheric'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0443304', 'cui_str': 'Silent'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0425943', 'cui_str': 'Duration of menstrual flow'}]",18.0,0.0623601,"Baseline post-movement synchronization in α-band activity in ipsilesional M1 was decreased after stroke compared with controls, and its tDCS-induced increase correlated with upper limb score in stroke survivors.","[{'ForeName': 'I-Ju', 'Initials': 'IJ', 'LastName': 'Kuo', 'Affiliation': 'Institute of Brain Science, Brain Research Center, National Yang-Ming University, No.155, Sec. 2, Linong St., Beitou Dist, Taipei City, 112, Taiwan.'}, {'ForeName': 'Chih-Wei', 'Initials': 'CW', 'LastName': 'Tang', 'Affiliation': 'Institute of Brain Science, Brain Research Center, National Yang-Ming University, No.155, Sec. 2, Linong St., Beitou Dist, Taipei City, 112, Taiwan.'}, {'ForeName': 'Yun-An', 'Initials': 'YA', 'LastName': 'Tsai', 'Affiliation': 'Department of Neurosurgery, Taipei Veterans General Hospital, No.201, Sec. 2, Shipai Rd., Beitou Dist, Taipei City, 112, Taiwan.'}, {'ForeName': 'Shuen-Chang', 'Initials': 'SC', 'LastName': 'Tang', 'Affiliation': 'Department of Neurosurgery, Taipei Veterans General Hospital, No.201, Sec. 2, Shipai Rd., Beitou Dist, Taipei City, 112, Taiwan.'}, {'ForeName': 'Chun-Jen', 'Initials': 'CJ', 'LastName': 'Lin', 'Affiliation': 'Institute of Brain Science, Brain Research Center, National Yang-Ming University, No.155, Sec. 2, Linong St., Beitou Dist, Taipei City, 112, Taiwan.'}, {'ForeName': 'Shih-Pin', 'Initials': 'SP', 'LastName': 'Hsu', 'Affiliation': 'Institute of Brain Science, Brain Research Center, National Yang-Ming University, No.155, Sec. 2, Linong St., Beitou Dist, Taipei City, 112, Taiwan.'}, {'ForeName': 'Wei-Kuang', 'Initials': 'WK', 'LastName': 'Liang', 'Affiliation': 'Institute of Cognitive Neuroscience, National Central University, No.300, Zhongda Rd., Zhongli Dist, Taoyuan City, 320, Taiwan.'}, {'ForeName': 'Chi-Hung', 'Initials': 'CH', 'LastName': 'Juan', 'Affiliation': 'Institute of Cognitive Neuroscience, National Central University, No.300, Zhongda Rd., Zhongli Dist, Taoyuan City, 320, Taiwan.'}, {'ForeName': 'Catharina', 'Initials': 'C', 'LastName': 'Zich', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, FMRIB, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, OX3 9DU, UK.'}, {'ForeName': 'Charlotte J', 'Initials': 'CJ', 'LastName': 'Stagg', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, FMRIB, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, OX3 9DU, UK.'}, {'ForeName': 'I-Hui', 'Initials': 'IH', 'LastName': 'Lee', 'Affiliation': 'Institute of Brain Science, Brain Research Center, National Yang-Ming University, No.155, Sec. 2, Linong St., Beitou Dist, Taipei City, 112, Taiwan. ihlee@vghtpe.gov.tw.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00706-1']
2243,32527344,[Clinical study of artesunate in the treatment of coronavirus disease 2019].,"OBJECTIVE


To discuss the effective of artesunate in the treatment of coronavirus disease 2019 (COVID-19).
METHODS


Using prospective method, the 43 cases of confirmed COVID-19 patients in Nanning Fourth People's Hospital from January 22nd to February 15th in 2020 were enrolled and divided into routine treatment group (n = 25) and artesunate treatment group (n = 18) by odd-even rule after admission. According to the guidelines, the routine treatment group was recommended to receive lopinavir/ritonavir 500 mg + α-aerosolized interferon 500×10 4  U, twice daily; the artesunate treatment group was given artesunate 60 mg, twice daily besides the routine treatment, for 10 days in both groups. During the treatment period, the pharynx swab test of 2019 novel coronavirus (2019-nCoV) nucleic acid was carried out every 2 days, and the routine blood test, liver and kidney functions, blood coagulation function and myocardial enzymes were re-examined. Chest CT was checked every 3 days after the treatment, and re-examined every 5 days after the condition was improved. The routine blood test and biochemical results of two groups were observed, and the efficacy evaluation was performed by monitoring the time for significant improvement of symptoms, negative conversion time of throat swab virus nucleic acid, lung lesion absorption time, adverse drug reactions and the length of hospital stay of the two groups.
RESULTS


There were no significant differences between the two groups in terms of gender, age, body weight, routine blood test and biochemical results before treatment. In artesunate treatment group, the time for significant improvement of symptoms (days: 3.33±1.91 vs. 4.84±2.19), negative conversion time of 2019-nCoV nucleic acid (days: 4.72±2.16 vs. 6.68±3.76), lung lesion absorption starting time (days: 5.39±2.36 vs. 7.48±3.78), lung lesion absorption greater than 70% time (days: 14.11±4.16 vs. 17.04±4.42) and the length of hospital stay (days: 16.56±3.71 vs. 18.04±3.97) were significantly shorter than those in routine treatment group, with significant differences (all P < 0.05). The incidence of adverse drug reactions in two groups had no significant difference (72.2% vs. 80.0%, P > 0.05).
CONCLUSIONS


Artesunate can shorten the treatment time of COVID-19, improve prognosis and eliminate pathogens, with fewer adverse reactions and a good application prospect.",2020,"There were no significant differences between the two groups in terms of gender, age, body weight, routine blood test and biochemical results before treatment.","[""43 cases of confirmed COVID-19 patients in Nanning Fourth People's Hospital from January 22nd to February 15th in 2020 were enrolled and divided into routine treatment group (n = 25) and"", 'coronavirus disease 2019 (COVID-19', 'coronavirus disease 2019']","['lopinavir/ritonavir 500 mg + α-aerosolized interferon 500×10 4  U, twice daily; the artesunate treatment group was given artesunate 60 mg, twice daily besides the routine treatment', 'artesunate', '2019 novel coronavirus (2019-nCoV) nucleic acid', 'artesunate treatment']","['negative conversion time of 2019-nCoV nucleic acid (days', 'gender, age, body weight, routine blood test and biochemical results', 'Chest CT', 'symptoms, negative conversion time of throat swab virus nucleic acid, lung lesion absorption time, adverse drug reactions and the length of hospital stay of the two groups', 'length of hospital stay', 'lung lesion absorption starting time', 'lung lesion absorption', 'incidence of adverse drug reactions']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0052432', 'cui_str': 'artesunate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0202823', 'cui_str': 'CT of chest'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439056', 'cui_str': 'Throat swab'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0577916', 'cui_str': 'Lesion of lung'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1301880', 'cui_str': 'Start time'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",2020.0,0.0199004,"There were no significant differences between the two groups in terms of gender, age, body weight, routine blood test and biochemical results before treatment.","[{'ForeName': 'Yanrong', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': ""Department of Intensive Care Unit, Nanning Fourth People's Hospital, Affiliated Infectious Disease Hospital of Guangxi Medical University, Nanning 530023, Guangxi Zhuang Autonomous Region, China.""}, {'ForeName': 'Fengyao', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': ""Department of Anesthesiology, Nanning Fourth People's Hospital, Affiliated Infectious Disease Hospital of Guangxi Medical University, Nanning 530023, Guangxi Zhuang Autonomous Region, China.""}, {'ForeName': 'Zhouhua', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': ""Department of Tuberculosis, Nanning Fourth People's Hospital, Affiliated Infectious Disease Hospital of Guangxi Medical University, Nanning 530023, Guangxi Zhuang Autonomous Region, China.""}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': ""Department of Pediatrics, Nanning Fourth People's Hospital, Affiliated Infectious Disease Hospital of Guangxi Medical University, Nanning 530023, Guangxi Zhuang Autonomous Region, China.""}, {'ForeName': 'Qingdong', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': ""Department of Tuberculosis, Nanning Fourth People's Hospital, Affiliated Infectious Disease Hospital of Guangxi Medical University, Nanning 530023, Guangxi Zhuang Autonomous Region, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': ""Department of Intensive Care Unit, Nanning Fourth People's Hospital, Affiliated Infectious Disease Hospital of Guangxi Medical University, Nanning 530023, Guangxi Zhuang Autonomous Region, China.""}, {'ForeName': 'Shiji', 'Initials': 'S', 'LastName': 'Tan', 'Affiliation': ""Department of Intensive Care Unit, Nanning Fourth People's Hospital, Affiliated Infectious Disease Hospital of Guangxi Medical University, Nanning 530023, Guangxi Zhuang Autonomous Region, China.""}, {'ForeName': 'Lianshao', 'Initials': 'L', 'LastName': 'Liang', 'Affiliation': ""Department of Tuberculosis, Nanning Fourth People's Hospital, Affiliated Infectious Disease Hospital of Guangxi Medical University, Nanning 530023, Guangxi Zhuang Autonomous Region, China.""}, {'ForeName': 'Beibei', 'Initials': 'B', 'LastName': 'Gong', 'Affiliation': ""Department of Nursing, Nanning Fourth People's Hospital, Affiliated Infectious Disease Hospital of Guangxi Medical University, Nanning 530023, Guangxi Zhuang Autonomous Region, China. Corresponding author: Wu Fengyao, Email: wufengyao@126.com.""}]",Zhonghua wei zhong bing ji jiu yi xue,['10.3760/cma.j.cn121430-20200312-00412']
2244,32527346,[Effect of Xuebijing injection on inflammatory markers and disease outcome of coronavirus disease 2019].,"OBJECTIVE


To observe the influence of Xuebijing injection on the inflammatory markers and prognosis of coronavirus disease 2019 (COVID-19) patients.
METHODS


Sixty severe COVID-19 patients admitted to Changsha Public Health Treatment Center (North Hospital of the First Hospital of Changsha City) from January to March in 2020 were randomly divided into routine treatment group, Xuebijing 50 mL group and Xuebijing 100 mL group, with 20 cases in each group. The routine treatment group was treated according to the National Health Commission's guide for COVID-19. On the basis of conventional treatment, Xuebijing injection was injected by 50 mL twice a day for 7 days in Xuebijing 50 mL group, while by 100 mL twice a day for 7 days in Xuebijing 100 mL group. The blood routine test, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), acute physiology and chronic health evaluation II (APACHE II) score, 2019 novel coronavirus (2019-nCoV) nucleic acid test and disease classification of three groups before and 8 days after treatment were observed.
RESULTS


(1) After treatment, the white blood cell count (WBC) and lymphocyte count (LYM) of three groups increased, meanwhile CRP and ESR decreased. Compared with routine treatment group, the WBC count of Xuebijing 100 mL group after treatment significantly increased (×10 9 /L: 7.12±0.55 vs. 5.67±0.51, P < 0.05), and the levels of CRP and ESR in Xuebijing 50 mL and 100 mL groups significantly decreased [CRP (mg/L): 32.3±4.6, 28.0±6.2 vs. 37.3±5.9; ESR (mm/1 h): 45.9±5.7, 40.5±7.4 vs. 55.3±6.6, all P < 0.05]. Compared with Xuebijing 50 mL group, the increase of WBC, and the decrease of CRP and ESR were more significant in Xuebijing 100 mL group [WBC (×10 9 /L): 7.12±0.55 vs. 5.82±0.49, CRP (mg/L): 28.0±6.2 vs. 32.3±4.6, ESR (mm/1 h): 40.5±7.4 vs. 45.9±5.7, all P < 0.05]. (2) After treatment, the APACHE II score of three groups decreased. In Xuebijing 100 mL group, the APACHE II score after treatment was significantly lower than those in routine treatment and Xuebijing 50 mL groups (12.3±1.5 vs. 16.5±1.6, 15.9±1.4, both P < 0.05). After treatment, the 2019-nCoV nucleic acid test in three groups partly turned negative, with 9 cases in routine treatment group, 8 cases in Xuebijing 50 mL group and 9 cases in Xuebijing 100 mL group, without significant difference (P > 0.05). The conditions of patients in the three groups were improved after treatment, among them, 8 cases in the routine treatment group were transformed into common type, 1 case into critical type; 9 cases and 12 cases of Xuebijing 50 mL group and 100 mL group were transformed into common type respectively. Xuebijing 100 mL group was improved more obviously than Xuebijing 50 mL group and routine treatment group (both P < 0.05).
CONCLUSIONS


The Xuebijing injection can effectively improve the inflammatory markers and prognosis of severe COVID-19 patients.",2020,"In Xuebijing 100 mL group, the APACHE II score after treatment was significantly lower than those in routine treatment and Xuebijing 50 mL groups (12.3±1.5 vs. 16.5±1.6, 15.9±1.4, both P < 0.05).","['Sixty severe COVID-19 patients admitted to Changsha Public Health Treatment Center (North Hospital of the First Hospital of Changsha City) from January to March in 2020', 'coronavirus disease 2019 (COVID-19) patients']","['Xuebijing injection', 'routine treatment group, Xuebijing 50 mL group and Xuebijing 100 mL group']","['CRP and ESR', 'blood routine test, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), acute physiology and chronic health evaluation II (APACHE II) score, 2019 novel coronavirus (2019-nCoV) nucleic acid test and disease classification', 'WBC', 'white blood cell count (WBC) and lymphocyte count (LYM', 'WBC count', 'APACHE II score', 'levels of CRP and ESR', '2019-nCoV nucleic acid test', 'meanwhile CRP and ESR', 'inflammatory markers and disease outcome']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0243028', 'cui_str': 'Acute physiology and chronic health evaluation II'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte count'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C4758051', 'cui_str': 'APACHE II (Acute Physiology and Chronic Health Evaluation II) score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0235473,"In Xuebijing 100 mL group, the APACHE II score after treatment was significantly lower than those in routine treatment and Xuebijing 50 mL groups (12.3±1.5 vs. 16.5±1.6, 15.9±1.4, both P < 0.05).","[{'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Wen', 'Affiliation': 'Department of Respiratory Medicine, the First Hospital of Changsha City, Changsha 410000, Hunan, China. Corresponding author: Zhou Zhiguo, Email: 15874863866@163.com.'}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Dixuan', 'Initials': 'D', 'LastName': 'Jiang', 'Affiliation': ''}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Huang', 'Affiliation': ''}]",Zhonghua wei zhong bing ji jiu yi xue,['10.3760/cma.j.cn121430-20200406-00386']
2245,32527349,[A clinical study on the determination of cuff pressure in artificial airway by minimum air leakage method].,"OBJECTIVE


To compare the cuff pressure and leakage volume and the related complications of filling the tracheal tube cuff by minimum air leakage method and cuff pressure manometer method after endotracheal intubation, so as to provide theoretical basis for patients who was intubated to obtain appropriate cuff pressure.
METHODS


A prospective randomized controlled study was conducted. 100 patients admitted to the department of critical care medicine of the Fifth Center Hospital in Tianjin from December 2015 to June 2019 were enrolled. According to the random number table method, the patients were divided into the experimental group and control group, with 50 patients in each group. After successful endotracheal intubation, all patients were placed in a supine position with the head of the bed raised by 30 degree angle. The experimental group used the minimum air leakage method, and used the cuff pressure manometer to obtain the cuff pressure. In the control group, cuff pressure was maintained at 25-30 cmH 2 O (1 cmH 2 O = 0.098 kPa). Parameters such as cuff pressure and ventilator leakage volume at the beginning and 4 hours, 8 hours after the inflation were compared between the two groups, as well as the incidence of ventilation-associated pneumonia (VAP) and airway complications after extubation.
RESULTS


Among the 100 cases, 53 were males and 47 were females. The age ranged from 23 to 87 years old, with an average of (68.53±8.46) years old. The intubation time ranged from 1 to 16 days. (1) At 4 hours and 8 hours after inflation, the cuff pressures of the two groups were lower than that of the first time of inflation, and the air leakage of the ventilator increased gradually with the extension of time. Compared with the control group, cuff pressures at each time point in the experimental group were significantly higher than those in the control group [mmHg (1 mmHg = 0.133 kPa): 33.72±9.14 vs. 25.68±5.26 at 0 hour, 30.54±7.81 vs. 24.35±4.93 at 4 hours, 26.57±5.64 vs. 22.42±4.14 at 8 hours, all P < 0.05], and ventilator leakage volumes were smaller than those in the control group (mL: 25.57±8.51 vs. 34.65±9.47 at 0 hour, 40.54±8.51 vs. 60.34±7.85 at 4 hours, both P < 0.05). (2) The incidence of VAP in the experimental group was significantly lower than that in the control group (4% vs. 10%, P < 0.05). There was no statistically significant difference in the incidence of other airway complications between the experimental group and control group (airway mucosal edema: 14% vs. 12%, ulcer: 8% vs. 6%, tracheal esophageal fistula: 0% vs. 0%, hoarseness: 4% vs. 6%, cough: 30% vs. 34%, sore throat: 28% vs. 32%, tracheal softening: 0% vs. 0%, cuff rupture: 10% vs. 8%, all P > 0.05).
CONCLUSIONS


The optimal cuff pressure is very important for preventing VAP and reducing airway complications. The minimum air leakage method makes the clinical obtained endotracheal intubation cuff pressure more accurately, with less air leakage, safe and effective, and it is worthy of clinical promotion.",2020,"There was no statistically significant difference in the incidence of other airway complications between the experimental group and control group (airway mucosal edema: 14% vs. 12%, ulcer: 8% vs. 6%, tracheal esophageal fistula: 0% vs. 0%, hoarseness: 4% vs. 6%, cough: 30% vs. 34%, sore throat: 28% vs. 32%, tracheal softening: 0% vs. 0%, cuff rupture: 10% vs. 8%, all P > 0.05).
","['The age ranged from 23 to 87 years old, with an average of (68.53±8.46) years old', '100 cases, 53 were males and 47 were females', '100 patients admitted to the department of critical care medicine of the Fifth Center Hospital in Tianjin from December 2015 to June 2019 were enrolled', 'patients who was intubated to obtain appropriate cuff pressure']",['tracheal tube cuff by minimum air leakage method and cuff pressure manometer method after endotracheal intubation'],"['incidence of ventilation-associated pneumonia (VAP) and airway complications', 'cuff pressure', 'cuff pressure and ventilator leakage volume', 'hoarseness', 'intubation time', 'air leakage of the ventilator', 'ventilator leakage volumes', 'incidence of VAP', 'incidence of other airway complications', 'cuff pressures', 'cuff pressure and leakage volume', 'tracheal esophageal fistula']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1319411', 'cui_str': 'Critical care medicine'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]","[{'cui': 'C0180212', 'cui_str': 'Endotracheal tube cuff'}, {'cui': 'C0333257', 'cui_str': 'Air leakage'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C2720530', 'cui_str': 'Manometer'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0333257', 'cui_str': 'Air leakage'}, {'cui': 'C2945595', 'cui_str': 'Tracheal'}, {'cui': 'C0014856', 'cui_str': 'Esophageal fistula'}]",100.0,0.0137986,"There was no statistically significant difference in the incidence of other airway complications between the experimental group and control group (airway mucosal edema: 14% vs. 12%, ulcer: 8% vs. 6%, tracheal esophageal fistula: 0% vs. 0%, hoarseness: 4% vs. 6%, cough: 30% vs. 34%, sore throat: 28% vs. 32%, tracheal softening: 0% vs. 0%, cuff rupture: 10% vs. 8%, all P > 0.05).
","[{'ForeName': 'Hongyun', 'Initials': 'H', 'LastName': 'Teng', 'Affiliation': 'Department of Critical Care Medicine, the Fifth Center Hospital in Tianjin, Tianjin 300457, China. Corresponding author: Cheng Xiuling, Email: tenghy_wzxyy@sina.com.'}, {'ForeName': 'Xiuling', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'Wanjie', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Yanlei', 'Initials': 'Y', 'LastName': 'Zuo', 'Affiliation': ''}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Hua', 'Affiliation': ''}, {'ForeName': 'Xiuhua', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': ''}]",Zhonghua wei zhong bing ji jiu yi xue,['10.3760/cma.j.cn121430-20200122-00143']
2246,32527353,[Effect of Xuebijing on inflammatory response and prognosis in patients with septic shock].,"OBJECTIVE


To study the effect of Xuebijing on inflammatory response and prognosis in patients with septic shock.
METHODS


A prospective randomized controlled study was conducted. Eighty septic shock patients admitted to department of critical care medicine of the First Affiliated Hospital of Zhengzhou University from January to December in 2019 were enrolled. The enrolled patients were divided into Xuebijing group and control group by randomized number table method, with 40 cases in each group. Both groups were strictly followed the guidelines for the diagnosis and treatment of septic shock to take comprehensive treatment measures against sepsis. On this basis, Xuebijing group received intravenous 100 mL Xuebijing injection twice a day for 7 days. Baseline data of enrolled patients were recorded. The levels of interleukin-6 (IL-6), procalcitonin (PCT), C-reactive protein (CRP) and heparin binding protein (HBP) were measured before treatment and 3, 7 and 10 days after treatment. Mechanical ventilation time, the length of intensive care unit (ICU) stay, total hospitalization time and 28-day mortality were recorded. The differences of every indicator between the two groups were compared. Independent risk factors affecting patient prognosis were analyzed by binary Logistic regression.
RESULTS


(1) There was no significant difference in baseline data such as gender, age, infection site, acute physiology and chronic health evaluation II (APACHE II) and sequential organ failure score (SOFA) between the two groups. (2) The levels of serum inflammatory factors in both groups showed a decreasing trend after treatment. Compared with the control group, IL-6 and HBP in the Xuebijing group significantly decreased on day 7 [IL-6 (ng/L): 66.20 (16.34, 163.71) vs. 79.81 (23.95, 178.64), HBP (ng/L): 95.59 (45.23, 157.37) vs. 132.98 (73.90, 162.05), both P < 0.05]; on day 10, PCT, CRP, IL-6 and HBP significantly decreased [PCT (μg/L): 1.14 (0.20, 3.39) vs. 1.31 (0.68, 4.21), CRP (mg/L): 66.32 (19.46, 115.81) vs. 89.16 (20.52, 143.76), IL-6 (ng/L): 31.90 (13.23, 138.74) vs. 166.30 (42.75, 288.10), HBP (ng/L): 62.45 (29.17, 96.51) vs. 112.33 (58.70, 143.96), all P < 0.05]. (3) Compared with the control group, mechanical ventilation time and the length of ICU stay were significantly shortened and the total hospitalization expenses were significantly reduced in Xuebijing group [mechanical ventilation time (hours): 57.0 (0, 163.5) vs. 168.0 (24.0, 282.0), the length of ICU stay (days): 8.80±4.15 vs. 17.13±7.05, the total hospitalization expenses (ten thousand yuan): 14.55±7.31 vs. 20.01±9.86, all P < 0.05]. There was no significant difference in 28-day mortality and the total hospitalization time [28-day mortality: 37.5% vs. 35.0%, the total hospitalization time (days): 13.05±8.44 vs. 18.30±9.59, both P > 0.05]. (4) Patients were divided into death and survival groups according to the prognosis, and univariate analysis showed that white blood cell (WBC), neutrophil percentage (NEU%), CRP, lactic acid (Lac), APACHE II score, IL-6, HBP were the factors influencing the prognosis of patients. The above indicators were further analyzed by Logistic regression, which showed that CRP, IL-6, and APACHE II score were independent risk factors for prognosis [odds ratio (OR) was 1.007, 1.828, 1.229, all P < 0.05].
CONCLUSIONS


Combined with Xuebijing to treat septic shock can reduce the body's inflammatory response to a certain extent, thereby reducing the time of mechanical ventilation, shortening the stay of ICU and reducing the total cost of hospitalization. But it cannot reduce the 28-day mortality of patients with septic shock.",2020,"The levels of interleukin-6 (IL-6), procalcitonin (PCT), C-reactive protein (CRP) and heparin binding protein (HBP) were measured before treatment and 3, 7 and 10 days after treatment.","['Eighty septic shock patients admitted to department of critical care medicine of the First Affiliated Hospital of Zhengzhou University from January to December in 2019 were enrolled', 'patients with septic shock']",['Xuebijing'],"['length of ICU stay', 'total hospitalization time', 'IL-6 and HBP', 'white blood cell (WBC), neutrophil percentage (NEU%), CRP, lactic acid (Lac), APACHE II score, IL-6, HBP', 'total cost of hospitalization', 'levels of interleukin-6 (IL-6), procalcitonin (PCT), C-reactive protein (CRP) and heparin binding protein (HBP', 'mechanical ventilation time and the length of ICU stay', 'PCT, CRP, IL-6 and HBP', 'CRP, IL-6, and APACHE II score', 'levels of serum inflammatory factors', '28-day mortality', 'Mechanical ventilation time, the length of intensive care unit (ICU) stay, total hospitalization time and 28-day mortality', 'IL-6', '28-day mortality and the total hospitalization time [28-day mortality', 'total hospitalization expenses', 'baseline data such as gender, age, infection site, acute physiology and chronic health evaluation II (APACHE II) and sequential organ failure score (SOFA']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1319411', 'cui_str': 'Critical care medicine'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C2933944', 'cui_str': 'Xuebijing'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0054878', 'cui_str': 'cationic antimicrobial protein CAP 37'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C1171400', 'cui_str': 'Neutrophil percentage'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0064582', 'cui_str': 'lactic acid'}, {'cui': 'C4758051', 'cui_str': 'APACHE II (Acute Physiology and Chronic Health Evaluation II) score'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0578491', 'cui_str': 'Infection by site'}, {'cui': 'C0243028', 'cui_str': 'Acute physiology and chronic health evaluation II'}, {'cui': 'C3494460', 'cui_str': 'Organ Failure Scores'}]",80.0,0.0764107,"The levels of interleukin-6 (IL-6), procalcitonin (PCT), C-reactive protein (CRP) and heparin binding protein (HBP) were measured before treatment and 3, 7 and 10 days after treatment.","[{'ForeName': 'Rongqing', 'Initials': 'R', 'LastName': 'Sun', 'Affiliation': 'Department of Critical Care Medicine, the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, Henan, China. Corresponding author: Sun Rongqing, Email: rongqing.sun@126.com.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Liang', 'Affiliation': ''}, {'ForeName': 'Hongfu', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Qilong', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Ma', 'Affiliation': ''}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wei', 'Affiliation': ''}, {'ForeName': 'Fangjie', 'Initials': 'F', 'LastName': 'Dong', 'Affiliation': ''}]",Zhonghua wei zhong bing ji jiu yi xue,['10.3760/cma.j.cn121430-20200401-00333']
2247,32535138,The effects of foam roll on perceptual and performance recovery during a futsal tournament.,"The present study investigated the efficacy of recovery by foam rolling (FR) on performance, psychological, and physiological parameters of futsal players in a simulated futsal tournament. In this randomized controlled trial design, four youth teams from Iran's national premier league participated in a simulated futsal tournament (five days, three matches). Sixteen youth futsal players from two teams (age: 19.1 ± 1.3 years old) were randomly distributed into two groups: (i) passive recovery (PR); and (ii) FR recovery. The FR recovery protocol consisted of five repetitions of 40 s separated by 20 s of rest on calf, quadriceps, hamstrings, and gluteus muscles 5 min after each match. The other group rested passively during the same period. The Yo-Yo intermittent recovery level 2, repeated sprint ability, vertical jump, and PRO agility tests were assessed pre- and post-tournament. Also, Hooper index (HI) and blood lactate concentrations were measured throughout matchdays. Data were analyzed by a repeated measure ANOVA and ANCOVA. Substantial improvements in HI on the second (ES:0.6) and third (ES:0.4) matchdays and faster lactate removal on the third (ES:0.3) matchday were observed in the FR group when compared to the PR group (p<0.05). Although FR recovery was slightly beneficial when compared to PR attenuated decrements in aerobic (-1.6%vs-9.7%) and anaerobic performance (-4.5%vs-1.3%), vertical jump (-1.6%vs-3.0%), and change of direction (-2.1%vs-4.3%), these effects were not statistically significant (p>0.05). The finding showed using FR during compact competitions expedites physical performance recovery, increases blood lactate clearance and leads to regenerate psychological characteristics. Therefore, along with other desirable recovery strategies, the use of FR could be recommended in short-term compacted futsal tournaments.",2020,Substantial improvements in HI on the second (ES:0.6) and third (ES:0.4) matchdays and faster lactate removal on the third (ES:0.3) matchday were observed in the FR group when compared to the PR group (p<0.05).,"['Sixteen youth futsal players from two teams (age: 19.1±1.3 years old', ""four youth teams from Iran's national premier league participated in a simulated futsal tournament (five days, three matches"", 'futsal players in a simulated futsal tournament']","['passive recovery (PR); and (ii) FR recovery', 'foam rolling (FR', 'foam roll']","['Hooper index (HI) and blood lactate concentrations', 'perceptual and performance recovery', 'repeated sprint ability, vertical jump, and PRO agility tests', 'lactate removal', 'blood lactate clearance', 'anaerobic performance']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1532535', 'cui_str': 'Indoor soccer'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0991510', 'cui_str': 'Foam'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",,0.0276004,Substantial improvements in HI on the second (ES:0.6) and third (ES:0.4) matchdays and faster lactate removal on the third (ES:0.3) matchday were observed in the FR group when compared to the PR group (p<0.05).,"[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Rahimi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Sadegh', 'Initials': 'S', 'LastName': 'Amani-Shalamzari', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Filipe Manuel', 'Initials': 'FM', 'LastName': 'Clemente', 'Affiliation': ""Escola Superior Desporto e Lazer, Instituto Politécnico de Viana do Castelo, Rua Escola Industrial e Comercial de Nun'Álvares, 4900-347, Viana do Castelo, Portugal; Instituto de Telecomunicações, Delegação da Covilhã, Lisboa 1049-001, Portugal. Electronic address: filipeclemente@esdl.ipvc.pt.""}]",Physiology & behavior,['10.1016/j.physbeh.2020.112981']
2248,32535161,Urethra-sparing stereotactic body radiotherapy for prostate cancer: quality assuranceof a randomized phase II trial.,"PURPOSE


To present the radiotherapy quality assurance (RTQA) results from a prospective multicenter phase II randomized trial of short vs. protracted urethra-sparing stereotactic body radiotherapy (SBRT) for localized prostate cancer (PCa).
METHODS


Between 2012 and 2015, 165 PCa patients from nine centers were randomized and treated with SBRT delivered either every-other-day (arm A, n=82) or once-a-week (arm B, n=83). 36.25 Gy in 5 fractions were prescribed to the prostate with (n=92) or without (n=73) inclusion of the seminal vesicles (SV), while the urethra planning-risk volume (uPRV) received 32.5 Gy. Patients were treated either with VMAT (n=112) or with IMRT (n=53). Deviations from protocol dose constraints, PTV homogeneity index (HI), PTV Dice similarity coefficient (DSC), and number of monitor units (MU) for each treatment plan were retrospectively analyzed. Dosimetric results of VMAT vs. IMRT and treatment plans with vs. without inclusion of SV were compared.
RESULTS


At least one major protocol deviation occurred in 51 patients (31%), while none was observed in 41. Protocol violations were more frequent in the IMRT group (p<0.001). Furthermore, the use of VMAT yielded better dosimetric results than IMRT for uPRV D 98%  (31.1 vs. 30.8 Gy, p<0.0001), PTV D 2%  (37.9 vs. 38.7 Gy p<0.0001), HI (0.09 vs. 0.10, p<0.0001), DSC (0.83 vs. 0.80, p<0.0001) and bladder wall V 50%  (24.5% vs. 33.5%, p=0.0001). To achieve its goals VMAT required less MU than IMRT (2275 vs. 3378, p<0.0001). The inclusion of SV in the PTV impacted negatively on the rectal wall V 90%  (9.1% vs. 10.4%, p=0.0003) and V 80%  (13.2% vs. 15.7%, p=0.0003).
CONCLUSIONS


Protocol deviations with potential impact on tumor control and/or toxicity occurred in 31% of patients in this prospective clinical trial. Protocol deviations were more frequent with IMRT. Prospective RTQA protocols should be strongly recommended for SBRT trials in order to minimize potential protocol deviations.",2020,"To achieve its goals VMAT required less MU than IMRT (2275 vs. 3378, p<0.0001).","['Between 2012 and 2015, 165 PCa patients from nine centers', 'localized prostate cancer (PCa', 'prostate cancer']","['radiotherapy quality assurance (RTQA', 'IMRT', 'Urethra-sparing stereotactic body radiotherapy', 'SBRT', 'VMAT vs. IMRT', 'protracted urethra-sparing stereotactic body radiotherapy (SBRT', 'VMAT']","['PTV homogeneity index (HI), PTV Dice similarity coefficient (DSC), and number of monitor units (MU', 'toxicity', 'DSC']","[{'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1512814', 'cui_str': 'Intensity modulated radiation therapy'}, {'cui': 'C0041967', 'cui_str': 'Urethral'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}, {'cui': 'C3489631', 'cui_str': 'Intensity-Modulated Arc Therapy'}]","[{'cui': 'C0454199', 'cui_str': 'Planning target volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",165.0,0.0661156,"To achieve its goals VMAT required less MU than IMRT (2275 vs. 3378, p<0.0001).","[{'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Jaccard', 'Affiliation': 'Radiation Oncology, University Hospital of Geneva, Geneva, Switzerland. Electronic address: maud.jaccard@hcuge.ch.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Zilli', 'Affiliation': 'Radiation Oncology, University Hospital of Geneva, Geneva, Switzerland; Faculty of Medicine, Geneva University, Geneva, Switzerland.'}, {'ForeName': 'Angèle', 'Initials': 'A', 'LastName': 'Dubouloz', 'Affiliation': 'Radiation Oncology, University Hospital of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Lluís', 'Initials': 'L', 'LastName': 'Escude', 'Affiliation': 'Radiation Oncology, Teknon Oncologic Institute, Barcelona, Spain.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Jorcano', 'Affiliation': 'Radiation Oncology, Teknon Oncologic Institute, Barcelona, Spain.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Linthout', 'Affiliation': 'Onze-Lieve-Vrouwziekenhuis, Aalst, Belgium.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Bral', 'Affiliation': 'Onze-Lieve-Vrouwziekenhuis, Aalst, Belgium.'}, {'ForeName': 'Wilko', 'Initials': 'W', 'LastName': 'Verbakel', 'Affiliation': 'Radiation Oncology Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bruynzeel', 'Affiliation': 'Radiation Oncology Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Björkqvist', 'Affiliation': 'Department of Oncology and Radiotherapy, Turku University Hospital, Turku, Finland; Department of Medical Physics, Division of Medical Imaging, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Minn', 'Affiliation': 'Department of Oncology and Radiotherapy, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Lev', 'Initials': 'L', 'LastName': 'Tsvang', 'Affiliation': 'Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Zvi', 'Initials': 'Z', 'LastName': 'Symon', 'Affiliation': 'Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Lencart', 'Affiliation': 'Portuguese Institut of Oncology, Porto, Portugal.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Oliveira', 'Affiliation': 'Portuguese Institut of Oncology, Porto, Portugal.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Ozen', 'Affiliation': 'Neolife Medical Center, Istanbul, Turkey.'}, {'ForeName': 'Ufuk', 'Initials': 'U', 'LastName': 'Abacioglu', 'Affiliation': 'Neolife Medical Center, Istanbul, Turkey.'}, {'ForeName': 'Juan María', 'Initials': 'JM', 'LastName': 'Pérez-Moreno', 'Affiliation': 'Hospital Universitario Sanchinarro, Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Rubio', 'Affiliation': 'Hospital Universitario Sanchinarro, Madrid, Spain.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Rouzaud', 'Affiliation': 'Radiation Oncology, University Hospital of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Miralbell', 'Affiliation': 'Radiation Oncology, University Hospital of Geneva, Geneva, Switzerland; Faculty of Medicine, Geneva University, Geneva, Switzerland; Radiation Oncology, Teknon Oncologic Institute, Barcelona, Spain.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.06.002']
2249,32542307,Effect of daily 2000 IU versus 800 IU vitamin D on blood pressure among adults age 60 years and older: a randomized clinical trial.,"BACKGROUND


Observational studies report higher blood pressure (BP) among individuals with lower 25-hydroxyvitamin D concentration. Whether dosage of vitamin D supplementation has a differential effect on BP control remains unclear.
OBJECTIVE


The study aimed to determine if daily vitamin D supplementation with 2000 IU is more effective than 800 IU for BP control among older adults.
METHODS


This randomized, double-blind, ancillary trial of the Zurich Multiple Endpoint Vitamin D Trial in Knee Osteoarthritis enrolled adults aged ≥60 y who underwent elective surgery due to severe knee osteoarthritis. Participants were randomly assigned to receive high dose (2000 IU) or standard dose (800 IU) daily vitamin D3 for 24 mo. Outcomes included daytime and 24-h mean systolic BP. BP variability and serum 25-hydroxyvitamin D concentration were examined in a post hoc and observational analysis.
RESULTS


Of the 273 participants randomly assigned, 250 participants completed a follow-up 24-h ambulatory BP monitoring (mean age: 70.4 ± 6.4 y; 47.2% men). The difference in daytime mean systolic BP reduction between the 2000 IU (n = 123) and 800 IU (n = 127) groups was not statistically significant (-2.75 mm Hg vs. -3.94 mm Hg; difference: 1.18 mm Hg; 95% CI: -0.68, 3.05; P = 0.21), consistent with 24-h mean systolic BP. However, systolic BP variability was significantly reduced with 2000 IU (average real variability: -0.37 mm Hg) compared to 800 IU vitamin D3 (0.11 mm Hg; difference: -0.48 mm Hg; 95% CI: -0.94, -0.01; P = 0.045). Independent of group allocation, maximal reductions in mean BP were observed at 28.7 ng/mL of achieved serum 25-hydroxyvitamin D concentrations.
CONCLUSIONS


While daily 2000 IU and 800 IU vitamin D3 reduced mean systolic BP over 2 y to a small and similar extent, 2000 IU reduced mean systolic BP variability significantly more compared with 800 IU. However, without a placebo control group we cannot ascertain whether vitamin D supplementation effectively reduces BP.This trial was registered at www.clinicaltrials.gov as NCT00599807.",2020,"However, systolic BP variability was significantly reduced with 2000 IU (average real variability: -0.37 mm Hg) compared to 800 IU vitamin D3 (0.11 mm Hg; difference: -0.48 mm Hg; 95% CI:","['older adults', 'individuals with lower 25-hydroxyvitamin D concentration', 'Knee Osteoarthritis enrolled adults aged ≥60 y who underwent elective surgery due to severe knee osteoarthritis', 'adults age 60 years and older', '273 participants randomly assigned', '250 participants completed a follow-up 24-h ambulatory BP monitoring (mean age: 70.4\xa0±\xa06.4 y; 47.2% men']","['daily vitamin D supplementation', '800 IU vitamin D', 'Zurich Multiple Endpoint Vitamin D Trial', 'vitamin D supplementation', 'vitamin D3']","['blood pressure', 'mean BP', '24-h mean systolic BP', 'daytime and 24-h mean systolic BP', 'systolic BP variability', 'BP variability and serum 25-hydroxyvitamin D concentration', 'blood pressure (BP', 'mean systolic BP', 'mean systolic BP variability', 'serum 25-hydroxyvitamin D concentrations', 'daytime mean systolic BP reduction']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",273.0,0.705876,"However, systolic BP variability was significantly reduced with 2000 IU (average real variability: -0.37 mm Hg) compared to 800 IU vitamin D3 (0.11 mm Hg; difference: -0.48 mm Hg; 95% CI:","[{'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Abderhalden', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Meyer', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Bess', 'Initials': 'B', 'LastName': 'Dawson-Hughes', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, MA, USA.'}, {'ForeName': 'E John', 'Initials': 'EJ', 'LastName': 'Orav', 'Affiliation': 'Department of Biostatistics, Harvard School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Ursina', 'Initials': 'U', 'LastName': 'Meyer', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'de Godoi Rezende Costa Molino', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Theiler', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Hannes B', 'Initials': 'HB', 'LastName': 'Stähelin', 'Affiliation': 'Department of Geriatrics, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Ruschitzka', 'Affiliation': 'Department of Cardiology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Egli', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Forman', 'Affiliation': ""Department of Nephrology, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Walter C', 'Initials': 'WC', 'LastName': 'Willett', 'Affiliation': 'Department of Nutrition, Harvard School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Heike A', 'Initials': 'HA', 'LastName': 'Bischoff-Ferrari', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Zurich, Switzerland.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa145']
2250,32542334,"A novel botanical formula improves eye fatigue and dry eye: a randomized, double-blind, placebo-controlled study.","BACKGROUND


With the frequent use of video display units, eye fatigue is becoming more common globally. An alternative nutritional strategy is needed to prevent the aggravation of eye fatigue symptoms.
OBJECTIVES


The objective was to evaluate the protective effect of a novel botanical combination of lutein ester, zeaxanthin, and extracts of blackcurrant, chrysanthemum, and goji berry on adults with eye fatigue in a randomized, double-blind, placebo-controlled clinical trial.
METHODS


We randomly allocated 360 participants into 4 groups to receive placebo and 3 doses of our formula (chewable tablets, containing 6 mg, 10 mg, or 14 mg of lutein) once daily for 90 d. Each participant had 3 visits at baseline (V1), 45 d (V2), and 90 d (V3) during the study.
RESULTS


Intervention with the formula improved individual scores of eye fatigue symptoms, including eye soreness, blurred vision, dry eye, foreign body sensation, and tearing. Compared with placebo, the formula at all 3 doses significantly decreased the total score of eye fatigue symptoms and increased the visuognosis persistence time at both V2 and V3. According to the Schirmer test, both 10-mg and 14-mg lutein formula groups had improved tear secretion at V3 compared with the placebo. The keratography results indicated that the first tear break-up time, average tear break-up time, and tear meniscus height were significantly increased after formula intervention. The formula at all 3 doses significantly increased the macular pigment optical density at V2 and V3 compared with the placebo, whereas optical coherence tomography showed no significant difference in retinal thickness and retinal volume across all groups at both visits.
CONCLUSIONS


Our botanical formula improves eye fatigue, dry eye, and macular function without changing the retinal structure, and thus it could serve as an effective nutritional strategy in improving eye fatigue without causing serious side effects.Clinical Trial Registry: chictr.org.cn (ChiCTR1800018987).",2020,"The formula at all 3 doses significantly increased the macular pigment optical density at V2 and V3 compared with the placebo, whereas optical coherence tomography showed no significant difference in retinal thickness and retinal volume across all groups at both visits.
",['adults with eye fatigue'],"['novel botanical combination of lutein ester, zeaxanthin, and extracts of blackcurrant, chrysanthemum, and goji berry', 'placebo and 3 doses of our formula (chewable tablets, containing 6 mg, 10 mg, or 14 mg of lutein', 'placebo']","['visuognosis persistence time', 'individual scores of eye fatigue symptoms, including eye soreness, blurred vision, dry eye, foreign body sensation, and tearing', 'tear break-up time, average tear break-up time, and tear meniscus height', 'eye fatigue, dry eye, and macular function', 'total score of eye fatigue symptoms', 'tear secretion', 'eye fatigue and dry eye', 'retinal thickness and retinal volume', 'macular pigment optical density']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004095', 'cui_str': 'Accommodative asthenopia'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0873128', 'cui_str': 'LUTEIN ESTERS'}, {'cui': 'C0078752', 'cui_str': 'zeaxanthin'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0453277', 'cui_str': 'Blackcurrants'}, {'cui': 'C0008720', 'cui_str': 'Chrysanthemum'}, {'cui': 'C1088997', 'cui_str': 'Goji Berry Plant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0304290', 'cui_str': 'Chewable tablet'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}]","[{'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004095', 'cui_str': 'Accommodative asthenopia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0863081', 'cui_str': 'Soreness in eyes'}, {'cui': 'C0344232', 'cui_str': 'Hazy vision'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0423602', 'cui_str': 'Foreign body sensation'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1827565', 'cui_str': 'Tear meniscus height'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C3850163', 'cui_str': 'Macular Pigment'}, {'cui': 'C0439164', 'cui_str': 'OD units'}]",360.0,0.320918,"The formula at all 3 doses significantly increased the macular pigment optical density at V2 and V3 compared with the placebo, whereas optical coherence tomography showed no significant difference in retinal thickness and retinal volume across all groups at both visits.
","[{'ForeName': 'Juntao', 'Initials': 'J', 'LastName': 'Kan', 'Affiliation': 'Nutrilite Health Institute, Shanghai, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, Aier Eye Hospital, Shanghai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Vanderbilt Epidemiology Center, Division of Epidemiology, Department of Medicine, Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Hongyue', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Nutrilite Health Institute, Shanghai, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Nutrilite Health Institute, Shanghai, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Nutrilite Health Institute, Shanghai, China.'}, {'ForeName': 'Chengrong', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'School of Pharmacy, Fudan University, Shanghai, China.'}, {'ForeName': 'Bryan Y', 'Initials': 'BY', 'LastName': 'Liu', 'Affiliation': 'College of Biotechnology, East China University of Science and Technology, Shanghai, China.'}, {'ForeName': 'Zhensheng', 'Initials': 'Z', 'LastName': 'Gu', 'Affiliation': 'Department of Ophthalmology, Xinhua Hospital, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Nutrilite Health Institute, Shanghai, China.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa139']
2251,32542695,Differing effects of zoledronic acid on bone microarchitecture and bone mineral density in men receiving androgen deprivation therapy: a randomised controlled trial.,"Androgen deprivation therapy (ADT) given to men with prostate cancer causes rapid and severe sex steroid deficiency leading to increased bone remodeling and accelerated bone loss. To examine the effects of a single dose of zoledronic acid on bone microarchitecture we conducted a two year randomised placebo controlled trial in 76 men, mean age [IQR] 67.8 years [63.8;73.9] with non-metastatic prostate cancer commencing adjuvant ADT; 39 were randomised to zoledronic acid and 37 to matching placebo. Bone microarchitecture was measured using high resolution-peripheral quantitative computed tomography (HR-pQCT). Using a mixed model, mean adjusted differences (MAD [95% CI]) between the groups are reported as the treatment effect at several time points. Over 24 months, zoledronic acid showed no appreciable treatment effect on the primary outcomes for total volumetric bone mineral density (vBMD); radius (6.7 mg HA/cm 3  [-2.0;15.4], p=0.21) and tibia (1.9 mg HA/cm 3  [-3.3;7.0], p=0.87). Similarly, there were no between group differences in other measures of microarchitecture, with the exception of a modest effect of zoledronic acid over placebo in total cortical vBMD at the radius over 12 months (17.3 mgHA/cm 3  [5.1;29.5]). In contrast, zoledronic acid showed a treatment effect over 24 months on aBMD by DXA at all sites, including lumbar spine (0.10 g/cm 2  [0.07;0.13]), p<0.001), and total hip (0.04 g/cm 2  [0.03;0.05], p<0.001). Bone remodeling markers were initially suppressed in the treatment group then increased but remained lower relative to placebo (MADs at 24 months CTX -176 ng/l [-275;-76], p<0.001, P1NP -18 mg/L [-32;-5], p<0.001). These findings suggest that a single dose of zoledronic acid over 2 years is ineffective in preventing the unbalanced bone remodeling and severe microstructural deterioration associated with ADT therapy. This article is protected by copyright. All rights reserved.",2020,"Over 24 months, zoledronic acid showed no appreciable treatment effect on the primary outcomes for total volumetric bone mineral density (vBMD); radius (6.7 mg HA/cm 3  [-2.0;15.4], p=0.21) and tibia (1.9 mg HA/cm 3  [-3.3;7.0], p=0.87).","['76 men, mean age [IQR] 67.8\u2009years [63.8;73.9] with non-metastatic prostate cancer commencing adjuvant ADT; 39 were randomised to', 'men with prostate cancer', 'men receiving androgen deprivation therapy']","['Androgen deprivation therapy (ADT', 'zoledronic acid', 'zoledronic acid over placebo', 'placebo']","['total cortical vBMD', 'total hip', 'bone microarchitecture and bone mineral density', 'Bone remodeling markers', 'total volumetric bone mineral density (vBMD); radius', 'lumbar spine', 'Bone microarchitecture']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4759295', 'cui_str': 'Non-metastatic prostate cancer'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0034627', 'cui_str': 'Bone structure of radius'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}]",76.0,0.38584,"Over 24 months, zoledronic acid showed no appreciable treatment effect on the primary outcomes for total volumetric bone mineral density (vBMD); radius (6.7 mg HA/cm 3  [-2.0;15.4], p=0.21) and tibia (1.9 mg HA/cm 3  [-3.3;7.0], p=0.87).","[{'ForeName': 'Ada S', 'Initials': 'AS', 'LastName': 'Cheung', 'Affiliation': 'Department of Medicine (Austin Health), The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Hoermann', 'Affiliation': 'Department of Medicine (Austin Health), The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ghasem-Zadeh', 'Affiliation': 'Department of Medicine (Austin Health), The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Alistair J', 'Initials': 'AJ', 'LastName': 'Tinson', 'Affiliation': 'Department of Medicine (Austin Health), The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Ly', 'Affiliation': 'Department of Medicine (Austin Health), The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Stefan V', 'Initials': 'SV', 'LastName': 'Milevski', 'Affiliation': 'Department of Medicine (Austin Health), The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Daryl', 'Initials': 'D', 'LastName': 'Lim Joon', 'Affiliation': 'Department of Radiation Oncology, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Zajac', 'Affiliation': 'Department of Medicine (Austin Health), The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Ego', 'Initials': 'E', 'LastName': 'Seeman', 'Affiliation': 'Department of Medicine (Austin Health), The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Mathis', 'Initials': 'M', 'LastName': 'Grossmann', 'Affiliation': 'Department of Medicine (Austin Health), The University of Melbourne, Victoria, Australia.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.4106']
2252,32542725,Hard and soft tissue alterations during the healing stage of immediate implant placement and provisionalization with or without connective tissue graft: A randomized clinical trial.,"AIMS


To evaluate the hard and soft tissue alterations of immediately placed and provisionalized implants with or without connective tissue graft (CTG) MATERIALS AND METHODS: Single unsalvageable maxillary incisors were replaced with immediately placed and provisionalized implants in 42 participants. The patients were randomly assigned to receive simultaneous CTG (test group) and not receive CTG (control group). Digital impression and cone beam computed tomography images were obtained before extraction and after 6 months. Mid-facial gingival margin migrations, soft tissue contour changes, and hard tissue remodeling were analyzed and compared between the two groups using three-dimensional superimposition method.
RESULTS


Forty participants completed the study. The test group showed significantly less buccal tissue collapse in the area 2-5 mm apical to the gingival margin. In both groups, the mid-facial gingival margin migrated in an apico-palatal direction and the socket void, except for a triangular space in the bucco-coronal region, demonstrated radiographic new bone formation without statistically significant differences.
CONCLUSIONS


The CTG used with immediate implant placement and provisionalization could compensate for the facial tissue collapse, but it did not benefit maintenance of the mid-facial gingival margin position during the 6 months follow-up. New bone formation observed radiographically can be expected in most areas of the socket void, regardless of CTG use (ChiCTR-1900028494).",2020,The test group showed significantly less buccal tissue collapse in the area 2-5 mm apical to the gingival margin.,"[' Single unsalvageable maxillary incisors were replaced with immediately placed and provisionalized implants in 42 participants', 'Forty participants completed the study']","['immediate implant placement and provisionalization with or without connective tissue graft', 'simultaneous CTG (test group) and not receive CTG', 'provisionalized implants with or without connective tissue graft (CTG']","['buccal tissue collapse', 'radiographic new bone formation', 'Mid-facial gingival margin migrations, soft tissue contour changes, and hard tissue remodeling']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0334168', 'cui_str': 'New bone formation'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018599', 'cui_str': 'Hard'}]",42.0,0.0425291,The test group showed significantly less buccal tissue collapse in the area 2-5 mm apical to the gingival margin.,"[{'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Oral Implantology, Peking University School and Hospital of Stomatology, Beijing, P.R. China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Di', 'Affiliation': 'Department of Oral Implantology, Peking University School and Hospital of Stomatology, Beijing, P.R. China.'}, {'ForeName': 'Shuxin', 'Initials': 'S', 'LastName': 'Ren', 'Affiliation': 'Department of Oral Implantology, Peking University School and Hospital of Stomatology, Beijing, P.R. China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Oral Implantology, Peking University School and Hospital of Stomatology, Beijing, P.R. China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Oral Implantology, Peking University School and Hospital of Stomatology, Beijing, P.R. China.'}]",Journal of clinical periodontology,['10.1111/jcpe.13331']
2253,32542748,Prospective randomized trial of treatment for mild ulnar neuropathy at the elbow.,,2020,,['mild ulnar neuropathy at the elbow'],[],[],"[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0154743', 'cui_str': 'Ulnar neuropathy'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}]",[],[],,0.0211104,,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Podnar', 'Affiliation': 'Institute of Clinical Neurophysiology, Division of Neurology, University Medical Center, Ljubljana, Slovenia.'}]",Muscle & nerve,['10.1002/mus.27005']
2254,32542818,Effects of supplementation with curcuminoids on serum adipokines in critically ill patients: a randomized double-blind placebo-controlled trial.,"Previous studies have shown a beneficial effect of curcuminoids supplementation on serum concentrations of adipokines; however, there are no published studies that have examined this effect among critically ill patients. We aimed to assess the effects of supplementation with curcuminoids on serum concentrations of leptin and adiponectin in critically ill patients with traumatic brain injury (TBI). In this trial, 62 critically ill patients with TBI, aged 18-65 years, were randomly allocated to receive either 500 mg/day curcuminoids (co-administered with 5 mg/day piperine) or matched placebo for 7 days. Patients in both intervention groups received routine treatments for TBI as well as enteral nutrition. Serum concentrations of leptin and adiponectin were measured at baseline and at the end of trial. We found a significant reduction in serum levels of leptin in both curcuminoids (47.1%) and placebo (22.8%) groups; though the magnitude of reduction was greater in the former (p < .05). Supplementation with curcumioinds was not found to alter serum concentrations of adiponectin (p > .05). Supplementation with curcumioinds significantly reduced serum levels of leptin but had no significant effect on adiponectin levels in critically ill patients with TBI. Further clinical trials, particularly those with a long-term period, are needed to confirm our findings.",2020,Supplementation with curcumioinds significantly reduced serum levels of leptin but had no significant effect on adiponectin levels in critically ill patients with TBI.,"['critically ill patients', '62 critically ill patients with TBI, aged 18-65\u2009years', 'critically ill patients with traumatic brain injury (TBI', 'critically ill patients with TBI']","['supplementation with curcuminoids', 'curcuminoids supplementation', '500\u2009mg/day curcuminoids (co-administered with 5 mg/day piperine) or matched placebo', 'placebo']","['serum adipokines', 'serum concentrations of leptin and adiponectin', 'serum concentrations of adiponectin', 'serum levels of leptin', 'adiponectin levels', 'Serum concentrations of leptin and adiponectin']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0071112', 'cui_str': 'piperine'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",62.0,0.259439,Supplementation with curcumioinds significantly reduced serum levels of leptin but had no significant effect on adiponectin levels in critically ill patients with TBI.,"[{'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Shadnoush', 'Affiliation': 'Faculty of Medicine, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Hoda', 'Initials': 'H', 'LastName': 'Zahedi', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Abdolreza', 'Initials': 'A', 'LastName': 'Norouzy', 'Affiliation': 'Department of Nutrition, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Amirhossein', 'Initials': 'A', 'LastName': 'Sahebkar', 'Affiliation': 'Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Sadeghi', 'Affiliation': 'Department of Community Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Atabak', 'Initials': 'A', 'LastName': 'Najafi', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Faculty of Medicine, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Hosseini', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Qorbani', 'Affiliation': 'Non-communicable Diseases Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Arezoo', 'Initials': 'A', 'LastName': 'Ahmadi', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Faculty of Medicine, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Hossein', 'Initials': 'SH', 'LastName': 'Ardehali', 'Affiliation': 'Department of Anesthesiology and Critical Care, Shohadaye Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Javad', 'Initials': 'MJ', 'LastName': 'Hosseinzadeh-Attar', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6749']
2255,32542854,Efficacy and safety of tadalafil vs tamsulosin in lower urinary tract symptoms (LUTS) as a result of benign prostate hyperplasia (BPH)-open label randomised controlled study.,"INTRODUCTION & AIM


Several newer medications have emerged for the management of lower urinary tract symptoms secondary to benign prostate hyperplasia (BPH). The efficacy/safety of PDE-5 inhibitors (Tadalafil 5 mg) in BPH-lower urinary tract symptoms (LUTS) has been sparingly assessed in the published English literature as compared with their established role in erectile dysfunction. We aim to assess the efficacy/safety of tadalafil vs tamsulosin in symptomatic patients of BPH in a tertiary care teaching institution.
METHODS


After obtaining an informed written consent and institutional ethics clearance, 100 patients of BPH with an IPSS score of more than 7, without any complications of the disease were computer randomised to receive therapy with either tamsulosin 0.4 mg or tadalafil 5 mg once daily for a period of 2 months. They were evaluated for its efficacy (IPSS, Peak flow rate, IIEF-5, quality of life index [QOL] and PVR) and safety (side effect profile) with monthly visit assessments for 2 months. Data were analysed statistically using ANOVA and unpaired t-tests.The protocol was registered with the CTRI/2018/03/012825.
RESULTS


Patients in both groups were comparable on basis of their demographic data, renal function, PSA and baseline efficacy parameters. Significant improvements were visualised amongst/within both groups for IPSS, however the intergroup improvement was not significant (P = .096). Similar trends were seen with peak flow rate and PVR with intergroup improvement differences not being significant (P = .552 and P = .131, respectively).Improvements in QOL index were more significant in the tamsulosin group (mean difference -2.3 vs -3.06 P = .010).The adverse effects were minor and were managed symptomatically without any drug discontinuity.
CONCLUSIONS


In summary, therefore, we may conclude that that once daily monotherapy with tadalafil 5 mg or tamsulosin 0.4 mg was equally efficacious in the management of moderate to severely bothersome LUTS in majority of patients as a result of BPH. The role of Tadalafil monotherapy in BPH patients with predominant storage LUTS merits further evaluation with larger trials.",2020,"Significant improvements were visualised amongst/within both groups for IPSS, however the intergroup improvement was not significant (P = .096).","['BPH patients with predominant storage LUTS', 'symptomatic patients of BPH in a tertiary care teaching institution', '100 patients of BPH with an IPSS score of more than 7, without any complications of the disease']","['tamsulosin', 'Tadalafil monotherapy', 'tadalafil', 'tamsulosin 0.4\xa0mg or tadalafil', 'tadalafil vs tamsulosin', 'PDE-5 inhibitors (Tadalafil']","['demographic data, renal function, PSA and baseline efficacy parameters', 'efficacy (IPSS, Peak flow rate, IIEF-5, quality of life index [QOL] and PVR) and safety (side effect profile', 'Efficacy and safety', 'QOL index', 'efficacy/safety', 'peak flow rate and PVR']","[{'cui': 'C1704272', 'cui_str': 'Benign prostatic hyperplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C1318700', 'cui_str': 'Phosphodiesterase 5 inhibitor'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C0729283', 'cui_str': 'Peak flow rate (respiratory)'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index'}, {'cui': 'C0242852', 'cui_str': 'Proliferative vitreoretinopathy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0394427,"Significant improvements were visualised amongst/within both groups for IPSS, however the intergroup improvement was not significant (P = .096).","[{'ForeName': 'Iqbal', 'Initials': 'I', 'LastName': 'Singh', 'Affiliation': 'Department of Surgery (Urology), University College of Medical Sciences (University of Delhi) & GTB Hospital, Delhi, India.'}, {'ForeName': 'Aravind', 'Initials': 'A', 'LastName': 'Tk', 'Affiliation': 'Department of Surgery (Urology), University College of Medical Sciences (University of Delhi) & GTB Hospital, Delhi, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Department of Surgery (Urology), University College of Medical Sciences (University of Delhi) & GTB Hospital, Delhi, India.'}]",International journal of clinical practice,['10.1111/ijcp.13530']
2256,32542879,The Adjunctive Effect of Intravenous Magnesium Sulfate in Acute Exacerbation of COPD: A Randomized Controlled Clinical Trial.,"Chronic Obstructive Pulmonary Disease (COPD) is the third leading cause of death worldwide. Acute exacerbation of COPD (AECOPD) is a serious event during the natural course of the disease. Despite many clinical trials on the management of AECOPD, treatment has not changed significantly during the past decades. Intravenous (IV) magnesium sulfate (MgS04) has been proposed to enhance the bronchodilator effects of inhaled beta2-agonists. Magnesium is involved in many enzymatic processes. It relaxes bronchial smooth muscles through its calcium channel blocking properties and inhibitory effects on the release of acetylcholine from neuromuscular junctions. It also exerts anti-inflammatory effects by attenuating the respiratory neutrophil burst and decreasing histamine release from mast cells.",2020,It relaxes bronchial smooth muscles through its calcium channel blocking properties and inhibitory effects on the release of acetylcholine from neuromuscular junctions.,"['Chronic Obstructive Pulmonary Disease (COPD', 'Acute Exacerbation of COPD']","['Magnesium', 'Intravenous Magnesium Sulfate', 'Intravenous (IV) magnesium sulfate (MgS04']",['Acute exacerbation of COPD (AECOPD'],"[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}]","[{'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}]",,0.0879475,It relaxes bronchial smooth muscles through its calcium channel blocking properties and inhibitory effects on the release of acetylcholine from neuromuscular junctions.,"[{'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Vafadar Moradi', 'Affiliation': 'Emam Reza hospital, Faculty of medicine, Mashhad university of medical sciences, Mashhad, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Pishbin', 'Affiliation': 'Emam Reza hospital, Faculty of medicine, Mashhad university of medical sciences, Mashhad, Iran.'}, {'ForeName': 'Seyed Reza', 'Initials': 'SR', 'LastName': 'Habibzadeh', 'Affiliation': 'Emam Reza hospital, Faculty of medicine, Mashhad university of medical sciences, Mashhad, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Talebi Doluee', 'Affiliation': 'Emam Reza hospital, Faculty of medicine, Mashhad university of medical sciences, Mashhad, Iran.'}, {'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Soltanifar', 'Affiliation': 'Faculty of medicine, Tehran university of medical sciences, Tahran, Iran.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.14050']
2257,32542906,Effect of short-course exercise training on the frequency of exacerbations and physical activity in patients with COPD: A randomized controlled trial.,"BACKGROUND AND OBJECTIVE


Previous studies have suggested that early pulmonary rehabilitation (PR) programmes post-AECOPD are an effective and safe intervention for reducing hospital admissions and improving quality of life. This study assessed whether a short course of exercise training post-AECOPD with periodic reinforcement exercise training and phone call reminders reduces readmissions and increases physical activity in COPD patients.
METHODS


Subjects were randomized into either the (i) intervention group (IG), consisting of 4-8 weeks of training supervised by a physiotherapist and phone contact every 2 weeks by a case manager providing support and reinforcement of continuous exercise at home or (ii) usual care group (UG), which had no input by a physiotherapist or case manager. Readmissions were assessed at 12 months. Activities of all patients were assessed by an activity monitor at baseline, 3 and 12 months.
RESULTS


Altogether, 136 subjects were included and randomized (68 in IG and 68 in UG). The age, gender and FEV 1  % predicted were 75.0 ± 6.7 years, 132 males and 47.0 ± 16.2%, respectively. The mean number of readmissions for AECOPD (1.06 vs 1.72 times, P = 0.014) was less and time to first readmission was increased (146.8 vs 122.4 days, P = 0.005) in the IG versus UG at 12 months. At 12 months, there was no change in activity measured by activity monitor between the two groups.
CONCLUSION


This programme decreased exacerbation frequency and increased the time of readmissions for AECOPD. It did not improve physical activities and exercise tolerance at 12 months.",2020,"The mean number of readmissions for AECOPD (1.06 vs 1.72 times, P = 0.014) was less and time to first readmission was increased (146.8 vs 122.4 days, P = 0.005) in the IG versus UG at 12 months.","['Subjects', '136 subjects were included and randomized (68 in IG and 68 in UG', 'patients with COPD', 'COPD patients']","['exercise training post-AECOPD with periodic reinforcement exercise training and phone call reminders', 'short-course exercise training', 'training supervised by a physiotherapist and phone contact every 2\u2009weeks by a case manager providing support and reinforcement of continuous exercise at home or (ii) usual care group (UG), which had no input by a physiotherapist or case manager']","['mean number of readmissions for AECOPD', 'physical activity', 'activity', 'frequency of exacerbations and physical activity', 'physical activities and exercise tolerance', 'time to first readmission', 'time of readmissions for AECOPD', 'Readmissions', 'exacerbation frequency']","[{'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332182', 'cui_str': 'Periodic'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0687694', 'cui_str': 'Case manager'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",136.0,0.0854688,"The mean number of readmissions for AECOPD (1.06 vs 1.72 times, P = 0.014) was less and time to first readmission was increased (146.8 vs 122.4 days, P = 0.005) in the IG versus UG at 12 months.","[{'ForeName': 'Fanny Wai-San', 'Initials': 'FW', 'LastName': 'Ko', 'Affiliation': 'SH Ho Research Center in Respiratory Diseases, Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Wilson', 'Initials': 'W', 'LastName': 'Tam', 'Affiliation': 'Alice Lee Centre for Nursing Studies, National University of Singapore, Singapore.'}, {'ForeName': 'Eddy H S', 'Initials': 'EHS', 'LastName': 'Siu', 'Affiliation': 'Department of Physiotherapy, Prince of Wales Hospital, Hong Kong.'}, {'ForeName': 'Ka-Pang', 'Initials': 'KP', 'LastName': 'Chan', 'Affiliation': 'SH Ho Research Center in Respiratory Diseases, Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Jenny Chun-Li', 'Initials': 'JC', 'LastName': 'Ngai', 'Affiliation': 'SH Ho Research Center in Respiratory Diseases, Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'So-Shan', 'Initials': 'SS', 'LastName': 'Ng', 'Affiliation': 'SH Ho Research Center in Respiratory Diseases, Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Tat On', 'Initials': 'TO', 'LastName': 'Chan', 'Affiliation': 'SH Ho Research Center in Respiratory Diseases, Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'David Shu-Cheong', 'Initials': 'DS', 'LastName': 'Hui', 'Affiliation': 'SH Ho Research Center in Respiratory Diseases, Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong.'}]","Respirology (Carlton, Vic.)",['10.1111/resp.13872']
2258,32543020,Tolvaptan vs. furosemide-based diuretic regimens in patients hospitalized for heart failure with hyponatremia (AQUA-AHF).,"AIMS


Hyponatremia is associated with poorer outcomes and diuretic response in patients hospitalized for heart failure. This study compared a tolvaptan-based vs. furosemide-based diuretic regimen on short-term clinical responses in hyponatremic acute heart failure.
METHODS AND RESULTS


Prospective, randomized, open-label, parallel-group, single-centre study comparing oral tolvaptan vs. continuous infusion furosemide. Thirty-three subjects requiring hospitalization for acute congestive heart failure, and a serum sodium < 135 mmol/L, were randomized to tolvaptan 30 mg orally daily or furosemide 5 mg/h intravenously for initial 24 h, after which treatments could be escalated. Median daily dose throughout was tolvaptan 30 mg and furosemide 120 mg, with four subjects in each group requiring dose escalation. Urine output and net fluid balance were not different between groups at 24 h or subsequent time points up to 96 h. Changes in estimated glomerular filtration rate were comparable. Cystatin C improved at 24 h with tolvaptan compared with furosemide (-6.4 ± 11.8 vs. 4.1 ± 17.2% change, P = 0.036), but the effect was transient. No significant between group differences were seen for NT-proBNP, plasma renin activity, or urinary neutrophil gelatinase-associated lipocalin:Cr. Serum sodium, as well as copeptin levels, increased with tolvaptan compared with furosemide.
CONCLUSIONS


Oral tolvaptan was associated with similar, but not superior, diuresis compared with intravenous furosemide for acute heart failure with concomitant hyponatremia.",2020,"No significant between group differences were seen for NT-proBNP, plasma renin activity, or urinary neutrophil gelatinase-associated lipocalin:Cr.","['patients hospitalized for heart failure with hyponatremia (AQUA-AHF', 'patients hospitalized for heart failure', 'Thirty-three subjects requiring hospitalization for acute congestive heart failure, and a serum sodium', 'hyponatremic acute heart failure']","['Tolvaptan vs. furosemide-based diuretic regimens', 'tolvaptan-based vs. furosemide-based diuretic regimen', 'tolvaptan vs. continuous infusion furosemide', 'furosemide', 'tolvaptan', 'tolvaptan 30\xa0mg orally daily or furosemide']","['Urine output and net fluid balance', 'Serum sodium', 'Cystatin C', 'glomerular filtration rate', 'NT-proBNP, plasma renin activity, or urinary neutrophil gelatinase-associated lipocalin:Cr']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0015506', 'cui_str': 'Factor VIII'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0264719', 'cui_str': 'Acute congestive heart failure'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum'}, {'cui': 'C0857122', 'cui_str': 'Hyponatraemic'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}]","[{'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C2684746', 'cui_str': 'tolvaptan 30 MG'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0016284', 'cui_str': 'Fluid balance'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0206528', 'cui_str': 'Gelatinase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1956074', 'cui_str': 'Lipocalin'}]",33.0,0.0461433,"No significant between group differences were seen for NT-proBNP, plasma renin activity, or urinary neutrophil gelatinase-associated lipocalin:Cr.","[{'ForeName': 'Tien M H', 'Initials': 'TMH', 'LastName': 'Ng', 'Affiliation': 'School of Pharmacy, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Luanda P', 'Initials': 'LP', 'LastName': 'Grazette', 'Affiliation': 'Division of Cardiovascular Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Fong', 'Affiliation': 'Division of Cardiovascular Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Yoon', 'Affiliation': 'Division of Cardiovascular Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Mimi', 'Initials': 'M', 'LastName': 'Lou', 'Affiliation': 'School of Pharmacy, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Kuo', 'Affiliation': 'Division of Cardiovascular Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Rani Y', 'Initials': 'RY', 'LastName': 'Upadhyay', 'Affiliation': 'Division of Cardiovascular Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Han', 'Affiliation': 'School of Pharmacy, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Anilkumar', 'Initials': 'A', 'LastName': 'Mehra', 'Affiliation': 'Division of Cardiovascular Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Uri', 'Initials': 'U', 'LastName': 'Elkayam', 'Affiliation': 'Division of Cardiovascular Medicine, University of Southern California, Los Angeles, CA, USA.'}]",ESC heart failure,['10.1002/ehf2.12783']
2259,32543021,Effect of short-acting exenatide administered three times daily on markers of cardiovascular disease in type 1 diabetes: A randomized double-blind placebo-controlled trial.,"AIMS


To investigate the effect of adding the short-acting glucagon-like peptide 1 receptor agonist (GLP-1RA) exenatide to insulin treatment on markers of cardiovascular risk in type 1 diabetes.
MATERIALS AND METHODS


In a randomized, double-blind, parallel-group trial, 108 individuals with type 1 diabetes aged ≥18 years on multiple daily injection therapy with a body mass index >22.0 kg/m 2  and glycated haemoglobin concentration of 59 to 88 mmol/mol (7.5%-10.0%) were randomized (1:1) to preprandial subcutaneous injection of 10 μg exenatide (Byetta®) or placebo three times daily over 26 weeks as add-on treatment to existing insulin therapy. Reported markers of cardiovascular risk were secondary endpoints and were analyzed in a baseline-adjusted linear mixed model in the intention-to-treat population. The primary results of this study, the MAG1C (Meal-time Administration of exenatide for Glycaemic control in type 1 diabetes Cases) trial, were previously reported.
RESULTS


Exenatide changed total fat mass by -2.6 kg (95% confidence interval [CI] -3.6; -1.6; P < 0.0001) and lean body mass by -1.1 kg (95% CI -1.9; -0.4; P = 0.01) compared with placebo, as assessed by dual-energy X-ray absorptiometry. Fat mass reductions were similar for central and peripheral fat mass. Exenatide did not change levels of interleukin-2 or -6; tumour necrosis factor-α; C-reactive protein; N-terminal prohormone of brain natriuretic peptide; or 8-oxo-7,8-dihydroguanosine (RNA oxidation marker) and 8-oxo-7,8-dihydro-2'-deoxyguanosine (DNA oxidation marker).
CONCLUSIONS


Exenatide added to insulin therapy in type 1 diabetes for 26 weeks resulted in body weight loss primarily from fat mass reduction, but had no effect on biomarkers of cardiovascular disease risk.",2020,Exenatide did not change levels of interleukin-2 or -6; tumour necrosis factor-α,"['type 1 diabetes', '108 individuals with type 1 diabetes aged ≥18\u2009years on multiple daily injection therapy with a body mass index >22.0\u2009kg/m 2  and glycated haemoglobin concentration of 59 to 88\u2009mmol/mol (7.5%-10.0']","['exenatide', 'Exenatide', 'short-acting exenatide', ""8-oxo-7,8-dihydroguanosine (RNA oxidation marker) and 8-oxo-7,8-dihydro-2'-deoxyguanosine (DNA oxidation marker"", 'short-acting glucagon-like peptide 1 receptor agonist (GLP-1RA) exenatide to insulin treatment', 'preprandial subcutaneous injection of 10 μg exenatide (Byetta®) or placebo three times daily over 26\u2009weeks as add-on treatment to existing insulin therapy', 'placebo']","['cardiovascular risk', 'body weight loss', 'change levels of interleukin-2 or -6; tumour necrosis factor-α', 'lean body mass', 'cardiovascular disease', 'total fat mass', 'Fat mass reductions']","[{'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C4517859', 'cui_str': '7.5'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0050092', 'cui_str': '8-hydroxyguanosine'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0050078', 'cui_str': '8-hydroxy-deoxyguanosine'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1550738', 'cui_str': 'Before food'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C1636686', 'cui_str': 'Byetta'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",108.0,0.741312,Exenatide did not change levels of interleukin-2 or -6; tumour necrosis factor-α,"[{'ForeName': 'Nicklas J', 'Initials': 'NJ', 'LastName': 'Johansen', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Dejgaard', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Asger', 'Initials': 'A', 'LastName': 'Lund', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Schlüntz', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Emil L', 'Initials': 'EL', 'LastName': 'Larsen', 'Affiliation': 'Department of Clinical Pharmacology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Henrik E', 'Initials': 'HE', 'LastName': 'Poulsen', 'Affiliation': 'Department of Clinical Pharmacology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens P', 'Initials': 'JP', 'LastName': 'Goetze', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Holger J', 'Initials': 'HJ', 'LastName': 'Møller', 'Affiliation': 'Department of Clinical Biochemistry, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Henrik U', 'Initials': 'HU', 'LastName': 'Andersen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14078']
2260,32543056,Are high fresh gas flow rates necessary during the wash-in period in low-flow anesthesia?,"In low-flow anesthesia (LFA), there is a wash-in period in which usually high fresh gas flow (FGF) rates are used to achieve the required initial concentration of anesthetic agent in the alveoli. The aim of this study was to compare the efficiency, safety and the consumption of desflurane in LFA using constant FGF (1 L/min) and conventional LFA using high FGF (4 L/min) during the wash-in period. Eighty patients, who were scheduled for elective surgery under general anesthesia with endotracheal intubation, were enrolled in the study. Wash-in was accomplished with 1 L/min FGF (50% O2, 50% air) and 18% desflurane in group 1; and by 4 L/min FGF (50% O2, 50% air) and 6% desflurane in group 2. Throughout the surgery, the vaporizer was adjusted to maintain 0.6 to 0.8 minimum alveolar concentration (MAC). The time required to reach 0.7 MAC was shorter in group 1 (160 seconds [135-181] vs 288 seconds [240-500], P < .001). In 6 patients in group 1 and 13 in group 2, vaporizer settings were adjusted to maintain 0.6 to 0.8 MAC (P = .048). Desflurane consumption in the first hour and total desflurane consumption were higher in group 2 (P < .001 and P = .012, respectively). The efficiency of anesthesia in both the first hour and in total was higher in group 1 (P < .001). It is safe, more efficient, and economical to use 1 L/min FGF during the wash-in period in LFA.",2020,The efficiency of anesthesia in both the first hour and in total was higher in group 1 (P < .001).,"['Eighty patients, who were scheduled for elective surgery under general anesthesia with endotracheal intubation, were enrolled in the study']","['desflurane', 'low-flow anesthesia (LFA']","['total desflurane consumption', 'efficiency of anesthesia', 'Desflurane consumption', 'efficiency, safety', 'time required to reach 0.7 MAC']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0293921,The efficiency of anesthesia in both the first hour and in total was higher in group 1 (P < .001).,"[{'ForeName': 'Mahmut', 'Initials': 'M', 'LastName': 'Arslan', 'Affiliation': 'Department of Anesthesiology and Reanimation, School of Medicine, Kahramanmaras Sutcu Imam University, Kahramanmaras, Turkey.'}, {'ForeName': 'Gökçe', 'Initials': 'G', 'LastName': 'Gişi', 'Affiliation': 'Department of Anesthesiology and Reanimation, School of Medicine, Kahramanmaras Sutcu Imam University, Kahramanmaras, Turkey.'}, {'ForeName': 'Gözen', 'Initials': 'G', 'LastName': 'Öksüz', 'Affiliation': 'Department of Anesthesiology and Reanimation, School of Medicine, Kahramanmaras Sutcu Imam University, Kahramanmaras, Turkey.'}, {'ForeName': 'Hafize', 'Initials': 'H', 'LastName': 'Öksüz', 'Affiliation': 'Department of Anesthesiology and Reanimation, School of Medicine, Kahramanmaras Sutcu Imam University, Kahramanmaras, Turkey.'}, {'ForeName': 'Bora', 'Initials': 'B', 'LastName': 'Bilal', 'Affiliation': 'Department of Anesthesiology and Reanimation, School of Medicine, Kahramanmaras Sutcu Imam University, Kahramanmaras, Turkey.'}, {'ForeName': 'Ömer Faruk', 'Initials': 'ÖF', 'LastName': 'Boran', 'Affiliation': 'Department of Anesthesiology and Reanimation, School of Medicine, Kahramanmaras Sutcu Imam University, Kahramanmaras, Turkey.'}, {'ForeName': 'Feyza', 'Initials': 'F', 'LastName': 'Çalışır', 'Affiliation': 'Department of Anesthesiology and Reanimation, School of Medicine, Kahramanmaras Sutcu Imam University, Kahramanmaras, Turkey.'}]",The Kaohsiung journal of medical sciences,['10.1002/kjm2.12251']
2261,32543080,Trigonal-sparing versus trigonal-involved Botox injection for treatment of idiopathic overactive bladder: A randomized clinical trial.,"OBJECTIVE


To evaluate safety and efficacy of trigone-involved Botox injections in comparison with trigone-sparing injections in refractory idiopathic overactive bladder (OAB).
MATERIALS AND METHODS


One hundred and three patients randomly received a 100-IU intradetrusal injection of Botox either sparing the trigone (52 patients) or involving the trigone (51 patients). Patients were prospectively evaluated at 1, 3, and 6 months. Efficacy was evaluated by 3-day voiding diaries, OAB symptom score (OABSS), and pressure flow study. Any complications were recorded. An ascending cystogram was done at 3 months for detection of vesicoureteral reflux. Urinary tract infection (UTI) was estimated on urine culture basis. Primary outcome was the difference of total OABSS at 3 months.
RESULTS


The mean age ± SD was 34.3 ± 10 years (range 18-59 years). There was a reduction of episodes of all components of OAB in both groups in comparison with baseline by the end of the study but without significant difference between both groups. The trigonal-sparing group had less score of frequency compared with the trigonal-involved group throughout the study period (P < .05). There was no difference in OABSS at 3 months (1.5 ± 0.4 vs 1.6 ± 0.3, P .875). Two patients in the trigonal-involved group out of 51 (3.9%) were in need of clean intermittent catheterization because of voiding difficulty and a postvoid residual > 200 mL. There was a higher rate of UTI in the trigonal-involved group ranging from 5.6% up to 11.7% at each follow-up visit. No patient had reflux.
CONCLUSION


Trigone injections are not superior to trigone-sparing injections. On the contrary, the incidence of UTI and voiding difficulty were higher. The concept of reflux induced by trigonal injection has not been proven.",2020,The trigonal-sparing group had less score of frequency compared with the trigonal-involved group throughout the study period (P < .05).,"['idiopathic overactive bladder', 'The mean age\u2009±\u2009SD was 34.3\u2009±\u200910\u2009years', 'refractory idiopathic overactive bladder (OAB', 'Two patients in the trigonal-involved group out of 51 (3.9%) were in need of clean intermittent catheterization because of voiding difficulty and a postvoid residual\u2009>\u2009200\u2009mL', 'One hundred and three patients randomly received a']","['trigone-involved Botox injections', 'Trigonal-sparing versus trigonal-involved Botox injection', '100-IU intradetrusal injection of Botox either sparing the trigone (52 patients) or involving the trigone', 'trigone-sparing injections']","['score of frequency', '3-day voiding diaries, OAB symptom score (OABSS), and pressure flow study', 'Urinary tract infection (UTI', 'Efficacy', 'rate of UTI', 'total OABSS', 'OABSS', 'incidence of UTI and voiding difficulty', 'reduction of episodes of all components of OAB']","[{'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C2936294', 'cui_str': 'Clean Intermittent Catheterization'}, {'cui': 'C0241705', 'cui_str': 'Difficulty passing urine'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4517526', 'cui_str': '103'}]","[{'cui': 'C0447586', 'cui_str': 'Trigonal structure'}, {'cui': 'C0700702', 'cui_str': 'Botox'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",103.0,0.0736625,The trigonal-sparing group had less score of frequency compared with the trigonal-involved group throughout the study period (P < .05).,"[{'ForeName': 'Ahmed S', 'Initials': 'AS', 'LastName': 'El-Hefnawy', 'Affiliation': 'Urology Department, Mansoura Urology and Nephrology Center, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Elbaset', 'Affiliation': 'Urology Department, Mansoura Urology and Nephrology Center, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Diaa-Eldin', 'Initials': 'DE', 'LastName': 'Taha', 'Affiliation': 'Urology Department, Kafr El Sheikh University, Kafr El Sheikh, Egypt.'}, {'ForeName': 'Bassem S', 'Initials': 'BS', 'LastName': 'Wadie', 'Affiliation': 'Urology Department, Mansoura Urology and Nephrology Center, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Kenawy', 'Affiliation': 'Urology Department, Mansoura Urology and Nephrology Center, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Shokeir', 'Affiliation': 'Urology Department, Mansoura Urology and Nephrology Center, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Mohamed E', 'Initials': 'ME', 'LastName': 'Badry', 'Affiliation': 'Urology Department, El Menia University, El Menia, Egypt.'}]",Lower urinary tract symptoms,['10.1111/luts.12321']
2262,32543120,"A Randomized, Single-Blind, Placebo-Controlled, 3-Way Crossover Study to Evaluate the Effect of Therapeutic and Supratherapeutic Doses of Edaravone on QT/QTc Interval in Healthy Subjects.","This randomized, single-blind, 3-way crossover study assessed the effect of edaravone on QT interval, including an exposure-response analysis. Twenty-seven healthy Japanese male volunteers, aged 20 to 49 years, were randomly assigned to receive a single intravenous dose of each treatment in 1 of 3 sequences (n = 9 each): ACB, BAC, and CBA, where A was edaravone 60 mg (therapeutic dose), B was edaravone 300 mg (supratherapeutic dose), and C was normal saline (placebo). Electrocardiographs were collected to assess treatment effects. In an exposure-response analysis, a linear model was determined to be valid and indicated no statistically significant positive slope for the relationship between change from baseline in QTcF (ΔQTcF) and edaravone concentration (0.000155 ms/(ng/mL); P = .1478); upper bounds of 2-sided 90% confidence intervals after placebo adjustment (ΔΔQTcF) were <10 milliseconds at the geometric mean maximum concentration for each edaravone dose. Overall estimated values by time point of ΔΔQTcF ≤0.9 milliseconds, no outlier values, and no morphologic changes suggestive of repolarization abnormalities were observed. Analysis of heart rate, PR interval, and QRS duration also revealed no adverse findings. These data indicate that edaravone, even at supratherapeutic doses, does not produce clinically meaningful QT prolongation and has no clinically relevant cardiac effects.",2020,"These data indicate that edaravone, even at supratherapeutic doses, does not produce clinically meaningful QT prolongation and has no clinically relevant cardiac effects.","['Healthy Subjects', 'Twenty-seven healthy Japanese male volunteers, aged 20 to 49 years']","['edaravone 60\xa0mg (therapeutic dose), B was edaravone 300\xa0mg (supratherapeutic dose), and C was normal saline (placebo', 'Placebo', 'edaravone', 'Edaravone']","['QTcF (ΔQTcF) and edaravone concentration', 'repolarization abnormalities', 'heart rate, PR interval, and QRS duration']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0070694', 'cui_str': 'edaravone'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0070694', 'cui_str': 'edaravone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0429087', 'cui_str': 'PR interval - finding'}, {'cui': 'C0429025', 'cui_str': 'QRS complex duration'}]",27.0,0.27288,"These data indicate that edaravone, even at supratherapeutic doses, does not produce clinically meaningful QT prolongation and has no clinically relevant cardiac effects.","[{'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Shimizu', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Inoue', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Endo', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Nakamaru', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Natori', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.'}, {'ForeName': 'Masae', 'Initials': 'M', 'LastName': 'Kakubari', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Akimoto', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.'}, {'ForeName': 'Kazuoki', 'Initials': 'K', 'LastName': 'Kondo', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.814']
2263,32543122,Study within a trial protocol: Same-day consent vs. delayed consent in a randomized trial.,"BACKGROUND


Randomized trials are designed to evaluate the effects of health care interventions. The recruitment process in a randomized trial can be challenging. Poor recruitment can have a negative impact on the allocated budget and estimated completion date of the study and may result in an underpowered research that will not adequately answer the original research question.
AIM


We aim to perform a Study Within A Trial (SWAT) to evaluate the impact of same-day consent or delayed consent on recruitment and retention in the host trial.
METHODS


This SWAT is designed as an observational study. However, the host trial is a randomized controlled trial evaluating the effectiveness of an intensive lifestyle modification program in patients with peripheral arterial disease. For this trial and SWAT, same-day consent is defined as the patient giving consent on the same day, after the investigator has fully explained the predesigned information leaflet for the host trial. Delayed consent is defined as the patient feeling they still need further time to consider their decision to participate or not.
SWAT REGISTRATION


The SWAT was registered on the Northern Ireland Network for Trials Methodology Research.",2020,"However, the host trial is a randomized controlled trial evaluating the effectiveness of an intensive lifestyle modification program in patients with peripheral arterial disease.",['patients with peripheral arterial disease'],['intensive lifestyle modification program'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.1771,"However, the host trial is a randomized controlled trial evaluating the effectiveness of an intensive lifestyle modification program in patients with peripheral arterial disease.","[{'ForeName': 'Marah', 'Initials': 'M', 'LastName': 'Elfghi', 'Affiliation': 'School of Medicine, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Fionnuala', 'Initials': 'F', 'LastName': 'Jordan', 'Affiliation': 'School of Medicine, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Sherif', 'Initials': 'S', 'LastName': 'Sultan', 'Affiliation': 'Department of Vascular and Endovascular Surgery, University College Hospital, Galway, Ireland.'}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Tawfick', 'Affiliation': 'School of Medicine, National University of Ireland, Galway, Ireland.'}]",Journal of evidence-based medicine,['10.1111/jebm.12392']
2264,32543136,[ In vivo  Study of siRNA Silencing  XIAP  Gene to Reverse Taxol-resistance in Human Ovarian Cancer Cells].,"Objective


To study the relationship between down-regulated expression of X linked inhibitor of apoptosis protein (XIAP) gene and the reversal effect of taxol-resistance by using siRNA interference technology in the taxol-resistant ovarian cancer.
Methods


Randomly assigned the nude mice into six groups (6 in each group) . Group A: normal saline; Group B: taxol; Group C: siRNA-NC+normal saline; Group D: siRNA-NC+taxol; Group E: siRNA  XIAP +normal saline; Group F: siRNA  XIAP +taxol. Each group was dealt with the corresponding processing depending on the agreed protocol and the transplanted tumors had a multi-point injection with reagents related siRNA, one time every 3 days, 9 times (27 d) in total. Taxol (2 mg/kg) was used in the intraperitoneal injection, 0.2 mL every time, once a week, for four weeks. After 27 d of siRNA treatment, xenograft volumes and qualities were measured and the inhibitory rate was calculated; RNA expression levels and protein levels of  XIAP  gene in xenografts were detected respectively by real-time fluorescent quantitative PCR and Western blot. Apoptosis of the transplanted tumor cells was examined by TUNEL method.
Results


Among the six groups, the proliferation of transplanted tumor in Group F was the slowest, and the tumor inhibition rate was the highest compared with control Group A, followed by Group E, and the tumor inhibition rate was the lowest in Group C. Group F and E expressed the lowest XIAP mRNA and protein expressions (  P <0.05, vs. the other 4 groups) .The apoptosis rate was highest in Group F, followed by Group E, and lowest in Group A and C (  P <0.05).
Conclusion


XIAP  siRNA has synergy with taxol in taxol-resistant ovarian cancer cells.",2020,"apoptosis rate was highest in Group F, followed by Group E, and lowest in Group A and C (  P <0.05).
","['Human Ovarian Cancer Cells', 'Group B']","['siRNA  XIAP +taxol', 'normal saline', 'taxol', 'XIAP +normal saline; Group F', 'NC+normal saline', 'Taxol']","['tumor inhibition rate', 'inhibitory rate was calculated; RNA expression levels and protein levels of  XIAP  gene in xenografts', 'apoptosis rate', 'lowest XIAP mRNA and protein expressions', 'proliferation of transplanted tumor', 'xenograft volumes and qualities']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C1099354', 'cui_str': 'Small Interfering RNA'}, {'cui': 'C0528561', 'cui_str': 'X-Linked IAP Protein'}, {'cui': 'C0678133', 'cui_str': 'Taxol A'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0441840', 'cui_str': 'Group F'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0040649', 'cui_str': 'Genetic transcription'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}, {'cui': 'C0528561', 'cui_str': 'X-Linked IAP Protein'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0520484', 'cui_str': 'Xenogeneic transplantation'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0334094', 'cui_str': 'Proliferation'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",,0.030031,"apoptosis rate was highest in Group F, followed by Group E, and lowest in Group A and C (  P <0.05).
","[{'ForeName': 'Ran-Hong', 'Initials': 'RH', 'LastName': 'Li', 'Affiliation': ""Department of Obstetrics and Gynecology, Henan Provincial People's Hospital, Zhengzhou 450003, China.""}, {'ForeName': 'Chi', 'Initials': 'C', 'LastName': 'Yue', 'Affiliation': 'Department of Obstetrics and Gynecology, West China Second University Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Bao-Bao', 'Initials': 'BB', 'LastName': 'Wei', 'Affiliation': 'Department of Obstetrics and Gynecology, West China Second University Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Obstetrics and Gynecology, West China Second University Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Obstetrics and Gynecology, West China Second University Hospital, Sichuan University, Chengdu 610041, China.'}]",Sichuan da xue xue bao. Yi xue ban = Journal of Sichuan University. Medical science edition,['10.12182/20200560203']
2265,32543150,"[The Pharmacokinetics, Pharmacodynamics and Bioequivalence of Insulin Aspart Produced by the United Laboratories Evaluated by Euglycemic Clamp Study].","Objective


To investigate the pharmacokinetics (PK) and pharmacodynamics (PD) of a rapid-acting insulin analog-insulin aspart (the tested formulation) which was manufactured by The United Laboratories and to evaluate the bioequiavailability to the reference formulation (NovoRapid  ® ) produced by Novo Nordisk in Chinese healthy volunteers.
Methods


A total of 24 male healthy volunteers were recruited from February to April 2016 to participant in this before-after, single dose, and randomized crossover study. And the experimental observation was conducted on 2 test days respectively with a between-period from 7 to10 d. According to a random number table, the volunteers were divided into group A or B, group A was administrated with tested insulin aspart (IAsp) for the first time and reference NovoRapid  ®  for the second time and group B had the revered order differed from group A. The PK/PD of these insulin analogs were estimated by euglycemic clamp study.
Results


The relative biological effectiveness (reflecting gloucose-lowing effect) and bioavailability on behalf of plasma-drug concentration were 98.3±18.8% and 97.3%±8.3% respectively. For PK parameters, the 90% confidence interval (  CI ) of peak plasma insulin concentration (  C   max ) and area under the curve of insulin aspart concentration from 0 to 10 hours (  AUC   IAsp, 0-10 h ) of IAsp were 88.8%-106% (equivalent range 70%-143%) and 94.0%-100% (equivalent range 80%-125%) respectively; for PD parameters, the 90%  CI  of the maximum glucose infusion rate (  GIR   max ) and  AUC   GIR, 0-10 h  were 95.5%-113% (equivalent range 70%-143%) and 89.9%-104% (equivalent range 80%-125%) respectively, which indicated that IAsp and NovoRapid® was bioequivalent. One of the subjects discovered hyperuricemia without clinical symptoms and the rest had no clinically significant abnormalities in the safety indexes before and after the tests. No hypoglycemic events, allergic reactions, or local injection adverse reaction occurred in this trial.
Conclusion


The tested IAsp has comparable relative bioavailability to the reference NovoRapid  ® .",2020,"No hypoglycemic events, allergic reactions, or local injection adverse reaction occurred in this trial.
","['Chinese healthy volunteers', '24 male healthy volunteers']","['rapid-acting insulin analog-insulin aspart', 'tested insulin aspart (IAsp', 'Insulin Aspart']","['relative biological effectiveness', 'hypoglycemic events, allergic reactions, or local injection adverse reaction', 'peak plasma insulin concentration (  C   max ) and area under the curve of insulin aspart concentration', 'pharmacokinetics (PK) and pharmacodynamics (PD', 'maximum glucose infusion rate (  GIR   max ) and  AUC   GIR, 0-10 h', 'plasma-drug concentration']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0035023', 'cui_str': 'Biological Effectiveness, Relative'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",24.0,0.0351634,"No hypoglycemic events, allergic reactions, or local injection adverse reaction occurred in this trial.
","[{'ForeName': 'Hong-Ling', 'Initials': 'HL', 'LastName': 'Yu', 'Affiliation': 'Department of Endocrinology and Metabolism, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Endocrinology and Metabolism, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Jia-Qi', 'Initials': 'JQ', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology and Metabolism, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Hui-Wen', 'Initials': 'HW', 'LastName': 'Tan', 'Affiliation': 'Department of Endocrinology and Metabolism, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Ye-Rong', 'Initials': 'YR', 'LastName': 'Yu', 'Affiliation': 'Department of Endocrinology and Metabolism, West China Hospital, Sichuan University, Chengdu 610041, China.'}]",Sichuan da xue xue bao. Yi xue ban = Journal of Sichuan University. Medical science edition,['10.12182/20200560607']
2266,32543155,"[Effect of Biofeedback Combined with Task-oriented Training on Hand Function, Gesell Scale Score and Balance Ability in Children with Spastic Cerebral Palsy].","Objective


To analyze the effects of biofeedback combined with task-oriented training on hand function, Gesell's infant development scale score (Gesell) and balance ability in children with spastic cerebral palsy (SCP).
Methods


66 children with SCP admitted to our hospital from January 2016 to June 2018 were randomly divided into the control group and the observation group. The control group (  n =33) received conventional rehabilitation treatment, and the observation group (  n =33) received biofeedback combined with task-oriented training based on the treatment of control group. After 6-month treatment, Modified Ashworth scale (MAS) score, Berg balance scale (BBS) score, standing and walking function score in gross motor function scale (GMFM), assisting hand assessment scales (AHA) score, Gesell scale score and satisfaction of the children's parents were compared between the two groups.
Results


The MAS score after treatment was lower than that before treatment in both two groups (  P <0.05), and the BBS score after treatment was higher than that before treatment in both two groups (  P <0.05). After treatment, the MAS score in the observation group was lower than the control group, and the BBS score in the observation group was higher than the control group (  P <0.05). The scores of standing and walking function after treatment were higher than that before treatment in both two groups (  P <0.05). After treatment, the scores of standing and walking function in the observation group were higher than the control group (  P <0.05). The AHA score and Gesell developmental quotient (DQ) score after treatment were higher than that before treatment in both two groups (  P <0.05). After the treatment, the AHA score and Gesell DQ score in the observation group were higher than the control group (  P <0.05). The satisfaction rate of rehabilitation treatment in the observation group was higher than the control group (90.91% vs. 60.61%,  P <0.05).
Conclusion


Biofeedback combined with task-oriented training can improve balance ability, spasm relieve, hand function, development level, standing and walking function in the children with spastic cerebral palsy and increase the treatment satisfaction degree of children's guardians.",2020,"After the treatment, the AHA score and Gesell DQ score in the observation group were higher than the control group (  P <0.05).","['Children with Spastic Cerebral Palsy', '66 children with SCP admitted to our hospital from January 2016 to June 2018', 'children with spastic cerebral palsy (SCP', 'children with spastic cerebral palsy']","['Biofeedback Combined with Task-oriented Training', 'biofeedback combined with task-oriented training based on the treatment of control group', 'conventional rehabilitation treatment', 'biofeedback combined with task-oriented training', 'Biofeedback combined with task-oriented training']","['BBS score', 'AHA score and Gesell developmental quotient (DQ) score', 'balance ability, spasm relieve, hand function, development level, standing and walking function', 'Hand Function, Gesell Scale Score and Balance Ability', ""Modified Ashworth scale (MAS) score, Berg balance scale (BBS) score, standing and walking function score in gross motor function scale (GMFM), assisting hand assessment scales (AHA) score, Gesell scale score and satisfaction of the children's parents"", ""hand function, Gesell's infant development scale score (Gesell) and balance ability"", 'satisfaction rate of rehabilitation treatment', 'AHA score and Gesell DQ score', 'scores of standing and walking function', 'MAS score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0050451', 'cui_str': 'acetohydroxamic acid'}, {'cui': 'C0205714', 'cui_str': 'Infant Development'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C0026821', 'cui_str': 'Cramp'}, {'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0025048', 'cui_str': 'Meconium aspiration syndrome'}]",66.0,0.0134837,"After the treatment, the AHA score and Gesell DQ score in the observation group were higher than the control group (  P <0.05).","[{'ForeName': 'Jin-Rong', 'Initials': 'JR', 'LastName': 'Huang', 'Affiliation': 'Department of Neurorehabilitation for Children, Ganzhou Maternal and Child Health Hospital, Ganzhou 341000, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurorehabilitation for Children, Ganzhou Maternal and Child Health Hospital, Ganzhou 341000, China.'}, {'ForeName': 'Fang-Fang', 'Initials': 'FF', 'LastName': 'Wen', 'Affiliation': 'Department of Neurorehabilitation for Children, Ganzhou Maternal and Child Health Hospital, Ganzhou 341000, China.'}, {'ForeName': 'Fu-Jian', 'Initials': 'FJ', 'LastName': 'Chen', 'Affiliation': 'Department of Neurorehabilitation for Children, Ganzhou Maternal and Child Health Hospital, Ganzhou 341000, China.'}, {'ForeName': 'Ting-Ting', 'Initials': 'TT', 'LastName': 'Zhu', 'Affiliation': 'Department of Neurorehabilitation for Children, Ganzhou Maternal and Child Health Hospital, Ganzhou 341000, China.'}]",Sichuan da xue xue bao. Yi xue ban = Journal of Sichuan University. Medical science edition,['10.12182/20200360105']
2267,32543161,Therapeutic effect of inhaled budesonide in transient tachypnea of newborn: A placebo-controlled study.,"Transient tachypnea of the newborn (TTN) is a chest disease found in neonates. It varies from mild to severe and is accompanied by neonatal morbidity and respiratory complications. This is a prospective placebo-controlled study, identification number is TCTR20200513005, which was done in the neonatal unit of Tanta University Hospital between June 2016 and March 2018. This study comprised 100 neonates with TTN, which were divided into two groups. The first group (inhaled steroid group) consisted of 50 neonates with TTN who were exposed to inhalation of corticosteroids (budesonide 2 ml, 0.25 mg/ml suspension for nebulizer, AstraZeneca AB, Södertälje, Sweden), the first dose was administered within 6 h of birth and the second dose was given 12 h later. The second group (placebo group) consisted of 50 neonates with TTN who were exposed to placebo inhalation (2 ml of distilled sterile water). There was significant difference between both groups regarding Down score (P = 0.001), TTN clinical score (P = 0.001) and Saturation of Peripheral Oxygen (SpO 2 ) measured by pulse oximeter (P = 0.008), while there was nonsignificant difference between both groups regarding PH (P = 0.573), and this showed that clinically the inhaled steroid group is significantly better than the placebo group. Hence, this study concludes that since administration of inhaled budesonide showed improvement in TTN cases, it could be a recommended line of treatment for neonatal TTN.",2020,"There was significant difference between both groups regarding Down score (P = 0.001), TTN clinical score (P = 0.001) and Saturation of Peripheral Oxygen (SpO 2 ) measured by pulse oximeter (P = 0.008), while there was nonsignificant difference between both groups regarding PH (P = 0.573), and this showed that clinically the inhaled steroid group is significantly better than the placebo group.","['neonatal unit of Tanta University Hospital between June 2016 and March 2018', 'group) consisted of 50 neonates with TTN who were exposed to', '50 neonates with TTN who were exposed to inhalation of corticosteroids ', '100 neonates with TTN', 'transient tachypnea of newborn']","['inhaled budesonide', 'placebo inhalation', 'budesonide', 'placebo']","['TTN clinical score', 'Saturation of Peripheral Oxygen (SpO 2 ) measured by pulse oximeter', 'Transient tachypnea of the newborn (TTN']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0158940', 'cui_str': 'Transitory tachypnea of newborn'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0182109', 'cui_str': 'Pulse oximeter'}, {'cui': 'C0158940', 'cui_str': 'Transitory tachypnea of newborn'}]",50.0,0.114148,"There was significant difference between both groups regarding Down score (P = 0.001), TTN clinical score (P = 0.001) and Saturation of Peripheral Oxygen (SpO 2 ) measured by pulse oximeter (P = 0.008), while there was nonsignificant difference between both groups regarding PH (P = 0.573), and this showed that clinically the inhaled steroid group is significantly better than the placebo group.","[{'ForeName': 'Mohamed Shawky', 'Initials': 'MS', 'LastName': 'Elfarargy', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Tanta University, Tanta, Egypt; farargy2009@hotmail.com.'}, {'ForeName': 'Sally El-Sayed', 'Initials': 'SE', 'LastName': 'Abu-Risha', 'Affiliation': 'Department of Pharmacology & Toxicology, Faculty of Pharmacy, Tanta University, Egypt.'}, {'ForeName': 'Reham Lotfy', 'Initials': 'RL', 'LastName': 'Younis', 'Affiliation': 'Department of Physiology, Faculty of Medicine, Tanta University, Tanta, Egypt.'}]",Journal of population therapeutics and clinical pharmacology = Journal de la therapeutique des populations et de la pharmacologie clinique,['10.15586/jptcp.v27i2.663']
2268,32543162,Effects of alternate nostril breathing exercise on cardiac functions in healthy young adults leading a stressful lifestyle.,"Alternate nostril breathing (ANB) is one of the best and easiest breathing exercises. ANB exercise has beneficial effects on cardiac function in healthy and diseased people. The objectives of this study were to assess the effects of ANB exercise on cardiac physiology among healthy medical students. This was a prospective interventional study that was conducted in the Department of Physiology, Chittagong Medical College (CMC), Chattogram, Bangladesh, from July 2017 to June 2018. A total of 100 research participants (RPs) aged 18-20 years, Year-I medical students of CMC, were selected. A simple random sampling method was adopted. The selection was done after the inclusion and exclusion criteria were applied. The age and body mass index (BMI) of the RPs were analogous in both the control and experimental groups. Cardiac parameters, like pulse and blood pressure (BP), were measured. The initial baseline data were recorded for both groups and after 4 weeks. The research respondents of the experimental group performed ANB exercise for 4 weeks. The mean value pulse and BP were significantly (p < 0.001) changed after breathing exercise, compared to the values before the breathing exercise. The results of this study suggest that cardiac function significantly improves after the breathing exercise. Therefore, ANB can be recommended for increasing cardiac efficiency.",2020,"The mean value pulse and BP were significantly (p < 0.001) changed after breathing exercise, compared to the values before the breathing exercise.","['healthy young adults leading a stressful lifestyle', '100 research participants (RPs) aged 18-20 years, Year-I medical students of CMC, were selected', 'healthy and diseased people', 'Department of Physiology, Chittagong Medical College (CMC), Chattogram, Bangladesh, from July 2017 to June 2018', 'healthy medical students']","['ANB exercise', 'alternate nostril breathing exercise', 'Alternate nostril breathing (ANB']","['cardiac functions', 'cardiac function', 'Cardiac parameters, like pulse and blood pressure (BP', 'mean value pulse and BP']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}]","[{'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0595944', 'cui_str': 'Both anterior nares'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",100.0,0.0262245,"The mean value pulse and BP were significantly (p < 0.001) changed after breathing exercise, compared to the values before the breathing exercise.","[{'ForeName': 'Iffat', 'Initials': 'I', 'LastName': 'Jahan', 'Affiliation': 'Department of Physiology, Eastern Medical College, Cumilla, Bangladesh; runurono@gmail.com.'}, {'ForeName': 'Momtaz', 'Initials': 'M', 'LastName': 'Begum', 'Affiliation': 'Department of Physiology, Chittagong Medical College, Chattogram, Bangladesh.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Akhter', 'Affiliation': 'Department of Physiology, Chittagong Medical College, Chattogram, Bangladesh.'}, {'ForeName': 'Zakirul', 'Initials': 'Z', 'LastName': 'Islam', 'Affiliation': 'Department of Pharmacology, Eastern Medical College, Cumilla, Bangladesh.'}, {'ForeName': 'Mainul', 'Initials': 'M', 'LastName': 'Haque', 'Affiliation': 'Universiti Pertahanan Nasional Malaysia (National Defence University of Malaysia), Kuala Lumpur, Malaysia.'}, {'ForeName': 'Nusrat', 'Initials': 'N', 'LastName': 'Jahan', 'Affiliation': 'Department of Internal Medicine, United Hospital, Dhaka, Bangladesh.'}]",Journal of population therapeutics and clinical pharmacology = Journal de la therapeutique des populations et de la pharmacologie clinique,['10.15586/jptcp.v27i2.675']
2269,32543211,"Effects of Chiropractic Care on Strength, Balance, and Endurance in Active-Duty U.S. Military Personnel with Low Back Pain: A Randomized Controlled Trial.","Objectives:  To investigate whether chiropractic care influences strength, balance, and/or endurance in active-duty United States military personnel with low back pain (LBP).  Design:  This study employed a prospective randomized controlled trial using a pragmatic treatment approach. Participants were randomly allocated to 4 weeks of chiropractic care or to a wait-list control.  Interventions:  Chiropractic care consisted of spinal manipulation, education, advice, and reassurance.  Settings/Location:  Naval Air Technical Training Center branch clinic at the Naval Hospital Pensacola Florida.  Subjects:  One hundred ten active-duty military personnel 18-40 years of age with self-reported LBP.  Outcome measures:  Isometric pulling strength from a semisquat position was the primary outcome. Secondary outcomes were single-leg balance with eyes open and eyes closed, and trunk muscle endurance using the Biering-Sorensen test. Patient-reported outcomes such as pain severity and disability were also measured. Outcomes were measured at baseline and 4 weeks. Linear mixed-effects regression models over baseline and 4 weeks were used for analysis.  Results:  Participants had mean age of 30 years (18-40), 17% were female, 33% were non-white, and 86% reported chronic LBP. Mean maximum pulling strength in the chiropractic group increased by 5.08 kgs and decreased by 7.43 kgs in the wait-list group, with a statistically significant difference in mean change between groups ( p  = 0.003). Statistically significant differences in mean change between groups were also observed in trunk muscle endurance (13.9 sec,  p  = 0.002) and balance with eyes closed (0.47 sec,  p  = 0.01), but not in balance with eyes open (1.19 sec,  p  = 0.43). Differences in mean change between groups were statistically significant in favor of chiropractic for LBP-related disability, pain intensity and interference, and fear-avoidance behavior.  Conclusions:  Active-duty military personnel receiving chiropractic care exhibited improved strength and endurance, as well as reduced LBP intensity and disability, compared with a wait-list control.",2020,"Differences in mean change between groups were statistically significant in favor of chiropractic for LBP-related disability, pain intensity and interference, and fear-avoidance behavior.  ","['Subjects', 'One hundred ten active-duty military personnel 18-40 years of age with self-reported LBP', 'active-duty United States military personnel with low back pain (LBP', 'Participants had mean age of 30 years (18-40), 17% were female, 33% were non-white, and 86% reported chronic LBP', 'Active-Duty U.S. Military Personnel with Low Back Pain']","['chiropractic care or to a wait-list control', 'Chiropractic Care', 'Chiropractic care consisted of spinal manipulation, education, advice, and reassurance']","['LBP intensity and disability', 'Mean maximum pulling strength', 'pain severity and disability', 'LBP-related disability, pain intensity and interference, and fear-avoidance behavior', 'trunk muscle endurance', 'single-leg balance with eyes open and eyes closed, and trunk muscle endurance using the Biering-Sorensen test', 'Isometric pulling strength from a semisquat position', 'strength and endurance', 'Strength, Balance, and Endurance']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3831794', 'cui_str': 'Active duty military'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0008138', 'cui_str': 'Chiropractic'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0086586', 'cui_str': 'Manipulation of spine'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0204558', 'cui_str': 'Group reassurance'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0178494', 'cui_str': 'Avoidance behavior'}, {'cui': 'C0581755', 'cui_str': 'Skeletal muscle structure of trunk'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0266574', 'cui_str': 'Ablepharon'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0733755', 'cui_str': 'Position'}]",110.0,0.117342,"Differences in mean change between groups were statistically significant in favor of chiropractic for LBP-related disability, pain intensity and interference, and fear-avoidance behavior.  ","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Vining', 'Affiliation': 'Palmer Center for Chiropractic Research, Palmer College of Chiropractic, Davenport, IA, USA.'}, {'ForeName': 'Cynthia R', 'Initials': 'CR', 'LastName': 'Long', 'Affiliation': 'Palmer Center for Chiropractic Research, Palmer College of Chiropractic, Davenport, IA, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Minkalis', 'Affiliation': 'Palmer Center for Chiropractic Research, Palmer College of Chiropractic, Davenport, IA, USA.'}, {'ForeName': 'M Ram', 'Initials': 'MR', 'LastName': 'Gudavalli', 'Affiliation': 'College of Chiropractic Medicine, Keiser University, West Palm Beach, FL, USA.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Xia', 'Affiliation': 'Mechanical Engineering Department, Northern Illinois University, DeKalb, IL, USA.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Walter', 'Affiliation': 'Samueli Integrative Health Programs, H&S Ventures, Alexandria, VA, USA.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Coulter', 'Affiliation': 'RAND Corporation, Santa Monica, CA, USA.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Goertz', 'Affiliation': 'Department of Orthopedic Surgery, Duke University School of Medicine, Durham, NC, USA.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2020.0107']
2270,32543212,Mindfulness and Modified Medical Yoga as Intervention in Older Women with Osteoporotic Vertebral Fracture.,"Background:  People with osteoporotic vertebral compression fractures (VCFs) have decreased health-related quality of life (HRQoL). Yoga and mindfulness are methods that can promote well-being.  Objective:  The aim of this article was to explore the effect of mindfulness and modified medical yoga on HRQoL, stress, sleep, and pain in people 60 years or older with a diagnosed osteoporotic VCF.  Design:  The School of Osteoporosis in Linköping (SOL) is a pilot study with randomized groups.  Materials and Methods:  The SOL-study was scheduled to once a week for 10 weeks. Ten people were randomized to a theory (T) group, and ten people were randomized to a theory and mindfulness/medical yoga (MMY) group. The educational sessions lasted 60 min and were similar for the groups, but they took place at different facilities. An experienced physiotherapist supervised the MMY sessions for 60 min. Sleep quality and present stress experience were measured on a symmetric Likert scale. The numeric rating scale was used for pain, and EQ-5D, RAND-36, and Qualeffo-41 were used for HRQoL. The patient enablement instrument (PEI) was used to reflect how the participants coped with their illness.  Results:  Eight women in the MMY-group and seven women in the T-group completed the SOL study interventions. The adherence to the intervention program was 89% in the MMY-group and 87% in the T-group. There was no adverse consequence of the MMY training. After the 10-week intervention period, sleep quality ( p  = 0.018) and present stress ( p  = 0.043), but not perceived pain were improved in the MMY-group. The social function (SF) domain was improved in the MMY-group that was measured by both RAND-36 ( p  = 0.028) and Qualeffo-41 ( p  = 0.012). There was a trend toward a better PEI-score in the MMY-group compared with the T-group postintervention ( p  = 0.089).  Conclusion:  This article suggests that mindfulness and modified medical yoga supervised by a skilled physiotherapist may be a feasible way to improve SF, sleep, and stress in older women with osteoporotic VCFs.",2020,The social function (SF) domain was improved in the MMY-group that was measured by both RAND-36 ( p  = 0.028) and Qualeffo-41 ( p  = 0.012).,"['people 60 years or older with a diagnosed osteoporotic VCF', 'People with osteoporotic vertebral compression fractures (VCFs', 'Older Women with Osteoporotic Vertebral Fracture', 'older women with osteoporotic VCFs']","['mindfulness and modified medical yoga', 'Mindfulness and Modified Medical Yoga', 'theory and mindfulness/medical yoga (MMY']","['PEI-score', 'social function (SF) domain', 'Sleep quality and present stress experience', 'HRQoL, stress, sleep, and pain', 'pain', 'sleep quality', 'numeric rating scale was used for pain, and EQ-5D, RAND-36, and Qualeffo-41']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0012236', 'cui_str': ""DiGeorge's syndrome""}, {'cui': 'C0262431', 'cui_str': 'Compression fracture of vertebral column'}, {'cui': 'C0056079', 'cui_str': 'COF protocol'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",10.0,0.0451376,The social function (SF) domain was improved in the MMY-group that was measured by both RAND-36 ( p  = 0.028) and Qualeffo-41 ( p  = 0.012).,"[{'ForeName': 'Ann-Charlotte', 'Initials': 'AC', 'LastName': 'Grahn Kronhed', 'Affiliation': 'Rehab Väst, Local Health Care Services in the West of Östergötland, Östergötland, Sweden.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Enthoven', 'Affiliation': 'Division of Physiotherapy, Department of Medical and Health Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Spångeus', 'Affiliation': 'Department of Acute Internal Medicine and Geriatrics, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Catrin', 'Initials': 'C', 'LastName': 'Willerton', 'Affiliation': 'Rehab Väst, Local Health Care Services in the West of Östergötland, Östergötland, Sweden.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2019.0450']
2271,32543247,Prolonged enoxaparin therapy compared with standard-of-care antithrombotic therapy in opiate-treated patients undergoing primary percutaneous coronary intervention.,"A novel enoxaparin regimen consisting of intra-arterial bolus (0.75 mg/kg) followed by intravenous infusion (0.75 mg/kg/6 hours) has been developed as a possible solution to the delayed absorption of oral P2Y 12  inhibitors in opiate-treated ST-elevation myocardial infarction (STEMI) patients undergoing primary angioplasty. We aimed to study the feasibility of this regimen as an alternative to standard-of-care treatment (SOC) with unfractionated heparin ± glycoprotein IIb/IIIa antagonist (GPI). One hundred opiate-treated patients presenting with STEMI and accepted for primary angioplasty were randomized (1:1) to either enoxaparin or SOC. Fifty patients were allocated enoxaparin (median age 61, 40% females) and 49 allocated SOC (median age 62, 22% females). One developed stroke before angiography and was withdrawn. One SOC patient had a gastrointestinal bleed resulting in 1 g drop in hemoglobin and early cessation of GPI infusion. Two enoxaparin patients had transient minor bleeding: one transient gingival bleed and one episode of coffee ground vomit with no hemoglobin drop or hemodynamic instability. Two SOC and no enoxaparin group patients had acute stent thrombosis. These preliminary data support further study of this novel 6-hour enoxaparin regimen in opiate-treated PPCI patients.",2020,Two SOC and no enoxaparin group patients had acute stent thrombosis.,"['One hundred opiate-treated patients presenting with STEMI and accepted for primary angioplasty', 'Fifty patients were allocated', 'opiate-treated PPCI patients', 'median age 61, 40% females) and 49 allocated SOC (median age 62, 22% females', 'opiate-treated patients undergoing primary percutaneous coronary intervention']","['standard-of-care treatment (SOC) with unfractionated heparin ± glycoprotein IIb/IIIa antagonist (GPI', 'enoxaparin or SOC', 'enoxaparin therapy', 'standard-of-care antithrombotic therapy', 'enoxaparin']","['transient minor bleeding: one transient gingival bleed and one episode of coffee ground vomit with no hemoglobin drop or hemodynamic instability', 'gastrointestinal bleed', 'acute stent thrombosis']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0016011', 'cui_str': 'Glycoproteins IIb-IIIa'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0017759', 'cui_str': 'Glucose-6-phosphate isomerase'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C0948268', 'cui_str': 'Hemodynamic instability'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}]",50.0,0.0391926,Two SOC and no enoxaparin group patients had acute stent thrombosis.,"[{'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Sumaya', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, Medical School, University of Sheffield , Sheffield, UK.'}, {'ForeName': 'William A E', 'Initials': 'WAE', 'LastName': 'Parker', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, Medical School, University of Sheffield , Sheffield, UK.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Judge', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, Medical School, University of Sheffield , Sheffield, UK.'}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'Hall', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, Medical School, University of Sheffield , Sheffield, UK.'}, {'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Orme', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, Medical School, University of Sheffield , Sheffield, UK.'}, {'ForeName': 'Zulfiquar', 'Initials': 'Z', 'LastName': 'Adam', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, Medical School, University of Sheffield , Sheffield, UK.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Richardson', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, Medical School, University of Sheffield , Sheffield, UK.'}, {'ForeName': 'Alexander M K', 'Initials': 'AMK', 'LastName': 'Rothman', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, Medical School, University of Sheffield , Sheffield, UK.'}, {'ForeName': 'Kenneth P', 'Initials': 'KP', 'LastName': 'Morgan', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, Medical School, University of Sheffield , Sheffield, UK.'}, {'ForeName': 'Julian P', 'Initials': 'JP', 'LastName': 'Gunn', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, Medical School, University of Sheffield , Sheffield, UK.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, Medical School, University of Sheffield , Sheffield, UK.'}]",Platelets,['10.1080/09537104.2020.1779925']
2272,32543258,Randomized phase III trial comparing switch-maintenance pemetrexed with observation followed by pemetrexed at progression in advanced NSCLC.,"Objectives:  Two phase III trials show that maintenance pemetrexed therapy after platinum-doublet chemotherapy prolongs overall survival (OS) and progression free survival (PFS) in advanced non-squamous non-small-cell lung cancer (NSCLC). However, few patients in the control arms received pemetrexed at progression in these trials, performance status (PS) two patients were ineligible and few of the participants were elderly. Thus, we designed this study comparing immediate switch - maintenance pemetrexed therapy with pemetrexed at progression after platinum-doublet chemotherapy. Methods:  Patients with stage IIIB/IV non-squamous NSCLC, ≥18 years, PS 0-2, and non-progression after four courses of carboplatin/vinorelbine were randomized to receive immediate maintenance pemetrexed therapy or observation followed by pemetrexed at progression. The primary endpoint was OS, secondary endpoints were PFS, toxicity and health related quality of life (HRQoL). Results:  105 patients were randomized between May 2014 and September 2017. Median age was 67 years, 36% were >70 years, 9% had PS 2, 91% stage IV and 47% were women. In the observation arm, 73% received pemetrexed at progression. Patients in the maintenance arm had a numerically longer OS (median 12.0 vs. 10.0 months;  p  = .10) and a statistically significant longer PFS (median 3.1 vs. 1.9 months;  p  < .01). In multivariable analyses adjusting for baseline characteristics, there was a trend toward improved OS (HR 0.65, 95% CI 0.42-1.01);  p  = .05), and a significantly improved PFS (HR 0.53, 95% CI 0.35-0.80;  p  < .01). There were no significant differences in toxicity or HRQoL between the treatment arms. Conclusion:  There was a trend toward prolonged OS and significantly longer PFS from switch -  maintenance pemetrexed therapy when 73% of patients in the control arm received pemetrexed at progression.  ClinicalTrials.gov Identifier:  NCT02004184.",2020,Patients in the maintenance arm had a numerically longer OS (median 12.0 vs. 10.0 months;  p  = .10) and a statistically significant longer PFS (median 3.1 vs. 1.9 months;  p  < .01).,"['105 patients were randomized between May 2014 and September 2017', 'advanced non-squamous non-small-cell lung cancer (NSCLC', 'Patients with stage IIIB/IV non-squamous NSCLC', 'Median age was 67\u2009years, 36% were >70\u2009years, 9% had PS 2, 91% stage IV and 47% were women', 'advanced NSCLC']","['platinum-doublet chemotherapy', 'carboplatin/vinorelbine', 'pemetrexed']","['PFS', 'overall survival (OS) and progression free survival (PFS', 'numerically longer OS', 'PFS, toxicity and health related quality of life (HRQoL', 'toxicity or HRQoL']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4324656', 'cui_str': 'Non-squamous non-small cell lung cancer'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0528480', 'cui_str': 'Presenilin 2'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",105.0,0.255321,Patients in the maintenance arm had a numerically longer OS (median 12.0 vs. 10.0 months;  p  = .10) and a statistically significant longer PFS (median 3.1 vs. 1.9 months;  p  < .01).,"[{'ForeName': 'Tarje O', 'Initials': 'TO', 'LastName': 'Halvorsen', 'Affiliation': 'Department of Clinical and Molecular Medicine, NTNU, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Stokke', 'Affiliation': 'Department of Clinical and Molecular Medicine, NTNU, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Kristin T', 'Initials': 'KT', 'LastName': 'Killingberg', 'Affiliation': 'Department of Clinical and Molecular Medicine, NTNU, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Sunil X', 'Initials': 'SX', 'LastName': 'Raj', 'Affiliation': 'Department of Clinical and Molecular Medicine, NTNU, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Sveinung', 'Initials': 'S', 'LastName': 'Sørhaug', 'Affiliation': 'Department of Thoracic Medicine, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Odd Terje', 'Initials': 'OT', 'LastName': 'Brustugun', 'Affiliation': 'Department of Oncology, Oslo University Hospital, The Norwegian Radium Hospital, Oslo, Norway.'}, {'ForeName': 'Øystein', 'Initials': 'Ø', 'LastName': 'Fløtten', 'Affiliation': 'Department of Thoracic Medicine, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Helbekkmo', 'Affiliation': 'Department of Pulmonology, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Kjersti', 'Initials': 'K', 'LastName': 'Hornslien', 'Affiliation': 'Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Tesfaye', 'Initials': 'T', 'LastName': 'Madebo', 'Affiliation': 'Department of Pulmonary Medicine, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Sverre', 'Initials': 'S', 'LastName': 'Fluge', 'Affiliation': 'Department of Pulmonary Medicine, Haugesund Hospital, Haugesund, Norway.'}, {'ForeName': 'Bjørn Henning', 'Initials': 'BH', 'LastName': 'Grønberg', 'Affiliation': 'Department of Clinical and Molecular Medicine, NTNU, Norwegian University of Science and Technology, Trondheim, Norway.'}]","Acta oncologica (Stockholm, Sweden)",['10.1080/0284186X.2020.1778179']
2273,32543287,A Scoring System for Surgical Site Infection after Pancreaticoduodenectomy Using Clinical Data.,"Object:  To analyze the factors influencing surgical site infection (SSI) after pancreaticoduodenectomy and to establish a scoring system for predicting such infections.  Methods:  Patients who underwent pancreaticoduodenectomy in the Department of Hepatobiliary Surgery of the Second Affiliated Hospital of Chongqing Medical University from January 2015 to March 2019 were divided randomly into a model group and a test group in a proportion of 3:1. According to whether an SSI occurred after operation, the model group was divided into an incision-infection group and a non-infection group. Univariable analysis and multivariable regression analysis were used to analyze factors related to post-operative incision infection and to establish a clinical predictive scoring system. The scoring system was evaluated for the test group.  Results:  A total of 236 patients, 177 in the model group and 59 in the test group, were included. In the model group, univariable and logistic regression analysis showed that tumor nature (benign versus malignant), post-operative albumin concentration, pancreatic fistula formation, post-operative cough, and peri-operative blood transfusion were the independent risk factors for incision infection. Then we established a clinical predictive scoring system. In the test group, the area under the receiver operator characteristic curve of the system was 0.768 (p < 0.001, with sensitivity = 59.1% and specificity = 94.6%).  Conclusion:  The scoring system had good clinical prediction ability and high specificity, so it was worth using in the clinic.",2020,"In the test group, the area under the receiver operator characteristic curve of the system was 0.768 (p < 0.001, with sensitivity = 59.1% and specificity = 94.6%).  ","['A total of 236 patients, 177 in the model group and 59 in the test group, were included', 'Patients who underwent pancreaticoduodenectomy in the Department of Hepatobiliary Surgery of the Second Affiliated Hospital of Chongqing Medical University from January 2015 to March 2019']",[],"['tumor nature (benign versus malignant), post-operative albumin concentration, pancreatic fistula formation, post-operative cough, and peri-operative blood transfusion']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]",[],"[{'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic fistula'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]",236.0,0.0146812,"In the test group, the area under the receiver operator characteristic curve of the system was 0.768 (p < 0.001, with sensitivity = 59.1% and specificity = 94.6%).  ","[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Hu', 'Affiliation': 'Department of Hepatobiliary Surgery, the Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Hao-Yang', 'Initials': 'HY', 'LastName': 'Tan', 'Affiliation': 'Department of Hepatobiliary Surgery, the Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Xin-Wen', 'Initials': 'XW', 'LastName': 'Rao', 'Affiliation': 'Department of Hepatobiliary Surgery, the Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Jia-Yi', 'Initials': 'JY', 'LastName': 'Jiang', 'Affiliation': 'Department of Hepatobiliary Surgery, the Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Yang', 'Affiliation': 'Department of Hepatobiliary Surgery, the Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}]",Surgical infections,['10.1089/sur.2020.082']
2274,32543290,Effect of Fully Immersive Virtual Reality Treatment Combined with Exercise in Fibromyalgia Patients: A Randomized Controlled Trial.,"This trial was designed to evaluate the effects of fully immersive virtual reality (IVR) treatment combined with exercise training in fibromyalgia patients. Twenty patients were randomized into exercise group (EG) or IVR combined with exercise group (Exercise+IVR). The EG had combined exercise training consisted of 30 minutes of aerobic training and 30 minutes of Pilates training and Exercise+IVR group had the same protocol with EG plus 20 minutes of IVR, twice a week for 8 weeks. Visual analogue scale for pain, Modified Sensory Organisation Test for balance, Tampa Scale of Kinesiophobia for kinesiophobia, Fibromyalgia Impact Questionnaire for impact of fibromyalgia, Fatigue Severity Scale for fatigue, International Physical Activity Questionnaire for level of physical activity, six-minute walk test for functional capacity, and Short-Form 36 Health Survey for quality of life were used for evaluation. Pain, balance, kinesiophobia, impact of fibromyalgia, fatigue, level of physical activity, functional exercise capacity and quality of life scores improved significantly in both groups (p<0.05). Exercise+IVR group showed significant improvement compared to the EG regarding pain, kinesiophobia, fatigue, level of physical activity and mental component of quality of life (p<0.05). IVR treatment may be an effective method as an adjunctive therapy with other exercise trainings in fibromyalgia.",2020,"Exercise+IVR group showed significant improvement compared to the EG regarding pain, kinesiophobia, fatigue, level of physical activity and mental component of quality of life (p<0.05).","['fibromyalgia patients', 'Fibromyalgia Patients', 'Twenty patients']","['Fully Immersive Virtual Reality Treatment Combined with Exercise', 'aerobic training and 30 minutes of Pilates training and Exercise+IVR group had the same protocol with EG plus 20 minutes of IVR', 'fully immersive virtual reality (IVR) treatment combined with exercise training', 'exercise group (EG) or IVR combined with exercise group (Exercise+IVR']","['EG regarding pain, kinesiophobia, fatigue, level of physical activity and mental component of quality of life (p<0.05', 'Visual analogue scale for pain, Modified Sensory Organisation Test for balance, Tampa Scale of Kinesiophobia for kinesiophobia, Fibromyalgia Impact Questionnaire for impact of fibromyalgia, Fatigue Severity Scale for fatigue, International Physical Activity Questionnaire for level of physical activity, six-minute walk test for functional capacity, and Short-Form 36 Health Survey for quality of life', 'Pain, balance, kinesiophobia, impact of fibromyalgia, fatigue, level of physical activity, functional exercise capacity and quality of life scores']","[{'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",20.0,0.0587617,"Exercise+IVR group showed significant improvement compared to the EG regarding pain, kinesiophobia, fatigue, level of physical activity and mental component of quality of life (p<0.05).","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gulsen', 'Affiliation': 'Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation, Gazi University , , Ankara, Turkey.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Soke', 'Affiliation': 'Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation, Gazi University , , Ankara, Turkey.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Cekim', 'Affiliation': 'Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation, Gazi University , , Ankara, Turkey.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Apaydin', 'Affiliation': 'Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation, Gazi University , , Ankara, Turkey.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ozkul', 'Affiliation': 'Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation, Gazi University , , Ankara, Turkey.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Guclu-Gunduz', 'Affiliation': 'Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation, Gazi University , , Ankara, Turkey.'}, {'ForeName': 'D T', 'Initials': 'DT', 'LastName': 'Akcali', 'Affiliation': 'Faculty of Medicine, Department of Algology, Gazi University , , Ankara, Turkey.'}]",Assistive technology : the official journal of RESNA,['10.1080/10400435.2020.1772900']
2275,32543382,Cost Saving of Short Hospitalization Nonoperative Management for Acute Uncomplicated Appendicitis.,"BACKGROUND


Nonoperative management (NOM) of uncomplicated appendicitis has gained recognition as an alternative to surgery. In the largest published randomized trial (Appendicitis Acuta), patients received a 3-d hospital stay for intravenous antibiotics; however, cost implications for health care systems remain unknown. We hypothesized short stay protocols would be cost saving compared with a long stay protocol.
MATERIALS AND METHODS


We constructed a Markov model comparing the cost of three protocols for NOM of acute uncomplicated appendicitis: (1) long stay (3-d hospitalization), (2) short stay (1-d hospitalization), and (3) emergency department (ED) discharge. The long stay protocol was modeled on data from the APPAC trial. Model variables were abstracted from national database and literature review. One-way and two-way sensitivity analyses were performed to determine the impact of uncertainty on the model.
RESULTS


The long stay treatment protocol had a total 5-y projected cost of $10,735 per patient. The short stay treatment protocol costs $8026 per patient, and the ED discharge protocol costs $6,825, which was $2709 and $3910 less than the long stay protocol, respectively. One-way sensitivity analysis demonstrated that the relative risk of treatment failure with the short stay protocol needed to exceed 6.3 (absolute risk increase of 31%) and with the ED discharge protocol needed to exceed 8.75 (absolute risk increase of 45%) in order for the long stay protocol to become cost saving.
CONCLUSIONS


Short duration hospitalization protocols to treat appendicitis nonoperatively with antibiotics are cost saving under almost all model scenarios. Future consideration of patient preferences and health-related quality of life will need to be made to determine if short stay treatment protocols are cost-effective.",2020,"The short stay treatment protocol costs $8026 per patient, and the ED discharge protocol costs $6,825, which was $2709 and $3910 less than the long stay protocol, respectively.",['Acute Uncomplicated Appendicitis'],"['3-d hospital stay for intravenous antibiotics', 'Nonoperative management (NOM']","['ED discharge protocol costs', 'short stay treatment protocol costs', 'stay (3-d hospitalization), (2) short stay (1-d hospitalization), and (3) emergency department (ED) discharge', 'total 5-y projected cost']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}]","[{'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}]",,0.0383425,"The short stay treatment protocol costs $8026 per patient, and the ED discharge protocol costs $6,825, which was $2709 and $3910 less than the long stay protocol, respectively.","[{'ForeName': 'Max A', 'Initials': 'MA', 'LastName': 'Schumm', 'Affiliation': 'Department of Surgery, UCLA David Geffen School of Medicine, Los Angeles, California. Electronic address: mschumm@mednet.ucla.edu.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Childers', 'Affiliation': 'Department of Surgery, UCLA David Geffen School of Medicine, Los Angeles, California.'}, {'ForeName': 'James X', 'Initials': 'JX', 'LastName': 'Wu', 'Affiliation': 'Department of Surgery, UCLA David Geffen School of Medicine, Los Angeles, California.'}, {'ForeName': 'Kyle A', 'Initials': 'KA', 'LastName': 'Zanocco', 'Affiliation': 'Department of Surgery, UCLA David Geffen School of Medicine, Los Angeles, California.'}]",The Journal of surgical research,['10.1016/j.jss.2020.05.028']
2276,32543415,"Load bearing capacity and Weibull characteristics of inlay-retained resin-bonded fixed dental prosthesis made of all-ceramic, fiber-reinforced composite and metal-ceramic after cyclic loading.","PURPOSE


The objectives of this study were to evaluate the load bearing capacity of RBFDPs made of different materials after cyclic loading, and classify the failure types after loading.
MATERIALS AND METHODS


Sound human mandibular first premolars and first molar pairs (N = 60 per tooth type, n = 10 per group) were randomly divided into six experimental groups to receive one of the following inlay-retained RBFDP types: RC: Resin composite only, DFRC: Direct E-glass fiber-reinforced composite (FRC), IFRC: Indirect E-glass FRC, LS: Lithium disilicate glass-ceramic, ZR: Yttria-stabilized tetragonal zirconia, MC: Metal-ceramic. Box preparations were made in abutment teeth using diamond burs followed by standardized ultrasonic burs. The teeth were conditioned employing an etch-and-rinse adhesive system and the indirect RBFDPs were cemented adhesively. The specimens were subjected to cyclic loading for x1.200.000 in distilled water alternating between 5 and 55 °C (Zurich Chewing Simulator). They were then loaded to failure from the occlusal surface in the Universal Testing Machine (cross-head speed: 1 mm/min). Failure types were classified as repairable or irreparable depending on the location and size. Data were analyzed using Welch and Tamhane's T2 post-hoc tests (α = 0.05). Weibull modulus for each group was calculated based on parametric distribution analysis of censored data for maximum fracture load.
RESULTS


Mean load bearing capacity (N) of Groups LS (1274 ± 270), ZR (1567 ± 363) and MC (1544 ± 787) were significantly higher than those of other groups (p < 0.05). RC, DFRC, IFRC (601 ± 130 - 819 ± 270) and MC did not show significant difference (p > 0.05). Weibull modulus (m) was the highest in Group LS (m = 5.3) followed by Group RC (m = 5.1). Other groups presented Weibull moduli ranging between 1.4 and 3.3. Only in Group ZR, 2 early debonding occurred during cyclic loading. While in this group predominantly irreparable failures (debonding with without tooth fracture) were observed (8 out of 10), all other groups presented mainly single or a combination of repairable failures (chipping in the veneering material). DFRC, IDRC and MC did not show any debonding from the abutment teeth.
CONCLUSION


Considering load bearing capacity, repairable failure types and Weibull moduli, lithium disilicate seem to be more durable than those of other material options for posterior inlay-retained RBFDPs. Due to early debondings and catastrophic irreparable failure types, zirconia RBFDPs should be indicated with caution in the posterior region.",2020,"Considering load bearing capacity, repairable failure types and Weibull moduli, lithium disilicate seem to be more durable than those of other material options for posterior inlay-retained RBFDPs.","['Sound human mandibular first premolars and first molar pairs ', 'N\xa0=\xa060 per tooth type, n\xa0']","['Yttria-stabilized tetragonal zirconia, MC: Metal-ceramic', 'RBFDP types: RC: Resin composite only, DFRC: Direct E-glass fiber-reinforced composite (FRC), IFRC: Indirect E-glass FRC, LS: Lithium disilicate glass-ceramic, ZR']","['RC, DFRC, IFRC', 'DFRC, IDRC and MC', 'Mean load bearing capacity (N']","[{'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0227056', 'cui_str': 'Structure of mandibular left first molar tooth'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C1567733', 'cui_str': 'yttria stabilized tetragonal zirconia'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0060317', 'cui_str': 'Fiberglass'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C1568204', 'cui_str': 'IFNAR1 protein, human'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C1528812', 'cui_str': 'lithia disilicate'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}]","[{'cui': 'C1568204', 'cui_str': 'IFNAR1 protein, human'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1318107', 'cui_str': 'Load-Bearing'}]",,0.059044,"Considering load bearing capacity, repairable failure types and Weibull moduli, lithium disilicate seem to be more durable than those of other material options for posterior inlay-retained RBFDPs.","[{'ForeName': 'Kim-Chi', 'Initials': 'KC', 'LastName': 'Brunner', 'Affiliation': 'University of Zürich, Center for Dental and Oral Medicine, Division of Dental Biomaterials, Clinic for Reconstructive Dentistry, Zurich, Switzerland.'}, {'ForeName': 'Mutlu', 'Initials': 'M', 'LastName': 'Özcan', 'Affiliation': 'University of Zürich, Center for Dental and Oral Medicine, Division of Dental Biomaterials, Clinic for Reconstructive Dentistry, Zurich, Switzerland. Electronic address: mutluozcan@hotmail.com.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2020.103855']
2277,32543439,Use of a Machine Learning Program to Correctly Triage Incoming Text Messaging Replies From a Cardiovascular Text-Based Secondary Prevention Program: Feasibility Study.,"BACKGROUND


SMS text messaging programs are increasingly being used for secondary prevention, and have been shown to be effective in a number of health conditions including cardiovascular disease. SMS text messaging programs have the potential to increase the reach of an intervention, at a reduced cost, to larger numbers of people who may not access traditional programs. However, patients regularly reply to the SMS text messages, leading to additional staffing requirements to monitor and moderate the patients' SMS text messaging replies. This additional staff requirement directly impacts the cost-effectiveness and scalability of SMS text messaging interventions.
OBJECTIVE


This study aimed to test the feasibility and accuracy of developing a machine learning (ML) program to triage SMS text messaging replies (ie, identify which SMS text messaging replies require a health professional review).
METHODS


SMS text messaging replies received from 2 clinical trials were manually coded (1) into ""Is staff review required?"" (binary response of yes/no); and then (2) into 12 general categories. Five ML models (Naïve Bayes, OneVsRest, Random Forest Decision Trees, Gradient Boosted Trees, and Multilayer Perceptron) and an ensemble model were tested. For each model run, data were randomly allocated into training set (2183/3118, 70.01%) and test set (935/3118, 29.98%). Accuracy for the yes/no classification was calculated using area under the receiver operating characteristics curve (AUC), false positives, and false negatives. Accuracy for classification into 12 categories was compared using multiclass classification evaluators.
RESULTS


A manual review of 3118 SMS text messaging replies showed that 22.00% (686/3118) required staff review. For determining need for staff review, the Multilayer Perceptron model had highest accuracy (AUC 0.86; 4.85% false negatives; and 4.63% false positives); with addition of heuristics (specified keywords) fewer false negatives were identified (3.19%), with small increase in false positives (7.66%) and AUC 0.79. Application of this model would result in 26.7% of SMS text messaging replies requiring review (true + false positives). The ensemble model produced the lowest false negatives (1.43%) at the expense of higher false positives (16.19%). OneVsRest was the most accurate (72.3%) for the 12-category classification.
CONCLUSIONS


The ML program has high sensitivity for identifying the SMS text messaging replies requiring staff input; however, future research is required to validate the models against larger data sets. Incorporation of an ML program to review SMS text messaging replies could significantly reduce staff workload, as staff would not have to review all incoming SMS text messages. This could lead to substantial improvements in cost-effectiveness, scalability, and capacity of SMS text messaging-based interventions.",2020,"SMS text messaging programs have the potential to increase the reach of an intervention, at a reduced cost, to larger numbers of people who may not access traditional programs.",[],"['machine learning (ML) program', 'Machine Learning Program']","['false negatives', 'receiver operating characteristics curve (AUC), false positives, and false negatives', 'false positives']",[],"[{'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0086858', 'cui_str': 'Programmed Learning'}]","[{'cui': 'C0205558', 'cui_str': 'False negative'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0205557', 'cui_str': 'False positive'}]",,0.0500675,"SMS text messaging programs have the potential to increase the reach of an intervention, at a reduced cost, to larger numbers of people who may not access traditional programs.","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Lowres', 'Affiliation': 'Heart Research Institute, Sydney, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Duckworth', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Redfern', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Aravinda', 'Initials': 'A', 'LastName': 'Thiagalingam', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Clara K', 'Initials': 'CK', 'LastName': 'Chow', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, Australia.'}]",JMIR mHealth and uHealth,['10.2196/19200']
2278,32543440,Comparison of the Effects of Automated and Manual Record Keeping on Anesthetists' Monitoring Performance: Randomized Controlled Simulation Study.,"BACKGROUND


Anesthesia information management systems (AIMSs) automatically import real-time vital signs from physiological monitors to anesthetic records, replacing part of anesthetists' traditional manual record keeping. However, only a handful of studies have examined the effects of AIMSs on anesthetists' monitoring performance.
OBJECTIVE


This study aimed to compare the effects of AIMS use and manual record keeping on anesthetists' monitoring performance, using a full-scale high-fidelity simulation.
METHODS


This simulation study was a randomized controlled trial with a parallel group design that compared the effects of two record-keeping methods (AIMS vs manual) on anesthetists' monitoring performance. Twenty anesthetists at a tertiary hospital in Hong Kong were randomly assigned to either the AIMS or manual condition, and they participated in a 45-minute scenario in a high-fidelity simulation environment. Participants took over a case involving general anesthesia for below-knee amputation surgery and performed record keeping. The three primary outcomes were participants' (1) vigilance detection accuracy (%), (2) situation awareness accuracy (%), and (3) subjective mental workload (0-100).
RESULTS


With regard to the primary outcomes, there was no significant difference in participants' vigilance detection accuracy (AIMS, 56.7% vs manual, 56.7%; P=.50), and subjective mental workload was significantly lower in the AIMS condition than in the manual condition (AIMS, 34.2 vs manual, 46.7; P=.02). However, the result for situation awareness accuracy was inconclusive as the study did not have enough power to detect a difference between the two conditions.
CONCLUSIONS


Our findings suggest that it is promising for AIMS use to become a mainstay of anesthesia record keeping. AIMSs are effective in reducing anesthetists' workload and improving the quality of their anesthetic record keeping, without compromising vigilance.",2020,"With regard to the primary outcomes, there was no significant difference in participants' vigilance detection accuracy (AIMS, 56.7% vs manual, 56.7%; P=.50), and subjective mental workload was significantly lower in the AIMS condition than in the manual condition (AIMS, 34.2 vs manual, 46.7; P=.02).","['Participants took over a case involving general anesthesia for below-knee amputation surgery and performed record keeping', 'Twenty anesthetists at a tertiary hospital in Hong Kong']","['two record-keeping methods (AIMS vs manual', 'Automated and Manual Record Keeping']","['subjective mental workload', 'vigilance detection accuracy (%), (2) situation awareness accuracy (%), and (3) subjective mental workload (0-100', ""participants' vigilance detection accuracy""]","[{'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0002692', 'cui_str': 'Amputation of leg through tibia and fibula'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}]","[{'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0205554', 'cui_str': 'Automated'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C1704407', 'cui_str': '100'}]",,0.128488,"With regard to the primary outcomes, there was no significant difference in participants' vigilance detection accuracy (AIMS, 56.7% vs manual, 56.7%; P=.50), and subjective mental workload was significantly lower in the AIMS condition than in the manual condition (AIMS, 34.2 vs manual, 46.7; P=.02).","[{'ForeName': 'Man-Kei', 'Initials': 'MK', 'LastName': 'Tse', 'Affiliation': 'Department of Applied Psychology, Lingnan University, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Simon Y W', 'Initials': 'SYW', 'LastName': 'Li', 'Affiliation': 'Department of Applied Psychology, Lingnan University, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Tsz Hin', 'Initials': 'TH', 'LastName': 'Chiu', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Tuen Mun Hospital, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Chung Wai', 'Initials': 'CW', 'LastName': 'Lau', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Tuen Mun Hospital, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Ka Man', 'Initials': 'KM', 'LastName': 'Lam', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Tuen Mun Hospital, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Chun Pong Benny', 'Initials': 'CPB', 'LastName': 'Cheng', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Tuen Mun Hospital, Hong Kong, China (Hong Kong).'}]",JMIR human factors,['10.2196/16036']
2279,32543461,Gett'n on the bus: evaluation of Sentinel City®3.0 virtual simulation in community/population health clinical placement.,"Objectives The purpose of this project was to implement and evaluate the integration of a computer-based virtual simulation program into a community clinical course as an alternative or complement to conventional clinical with agencies or neighbourhoods. Securing quality community health clinical opportunities for undergraduate nursing students remains challenging. In addition, evidence of a theory-practice gap in community clinical education, particularly in non-traditional settings, suggests that nurse educators need to adopt different pedagogies to ensure that students will gain competencies necessary to practice community/population health nursing. In response, we piloted the use of Sentinel City®3.0, a virtual reality simulation program. Method A 5-point Likert-style questionnaire was administered to students randomly assigned to different clinical placements. Results Results indicated that there were no learning outcomes in which students in Sentinel City®3.0 reported percentages lower than students in agencies or geographical neighbourhoods. When there were statistically significant differences, students engaged in Sentinel City®3.0 performed better than students in other experiences. Conclusion We recommend further exploration of multi-contextual pedagogies for community clinical.",2020,"When there were statistically significant differences, students engaged in Sentinel City®3.0 performed better than students in other experiences.","['in community/population health clinical placement', 'undergraduate nursing students']","['computer-based virtual simulation program', 'Sentinel City®3.0 virtual simulation']",['learning outcomes'],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C3242284', 'cui_str': 'Population Health'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0209737,"When there were statistically significant differences, students engaged in Sentinel City®3.0 performed better than students in other experiences.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Chircop', 'Affiliation': 'School of Nursing, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Cobbett', 'Affiliation': 'School of Nursing, Dalhousie University, Halifax, NS, Canada.'}]",International journal of nursing education scholarship,['10.1515/ijnes-2019-0109']
2280,32543463,Pain control after laparoscopic cholecystectomy. A prospective study.,"AIM


The purpose of this study is to evaluate three different analgesic procedures after laparoscopic cholecystectomy for pain control.
MATERIAL OF STUDY


The study involved 183 patients who underwent laparoscopic cholecystectomy with the same technique for the induction and maintenance of the general anesthesia. They were divided into three different postoperative pain treatment groups: continuous infusion of Tramadol and Ketorolac with elastomeric pump, intraperitoneal topical instillation of Levobupivacaine, and intraperitoneal aerosolization of Levobupivacaine.
RESULTS


No differences were found in the demographics. shorter operating time was observed in group 1. Eight hours after surgery in groups 2 and 3, there was an increase in pain compared to patients in the first group. The request for postoperative analgesic assistance was lower in groups 1 and 2.
DISCUSSION


Various topical and intravenous ways for analgesic actions have been used to improve the pain control after laparoscopic procedures, individually and in comparison between them. The main result of our research is that the use of levobupivacaine employed in the topical intraperitoneal application anesthesia by instillation and nebulization, do not improve the postoperative pain in the first 24 hours after LC, compared with intravenous analgesic elastomeric pump.
CONCLUSIONS


Despite the positive data found in the literature, our observations have not shown a better pain control after laparoscopic cholecystectomy with the use of intraperitoneal analgesia compared to intravenous.
KEY WORDS


Gallstone disease, Gallbladder bladder, Laparoscopic cholecystectomy, Postoperative pain, Stones.",2020,"Eight hours after surgery in groups 2 and 3, there was an increase in pain compared to patients in the first group.",['183 patients who underwent laparoscopic cholecystectomy with the same technique for the induction and maintenance of the general anesthesia'],"['Tramadol and Ketorolac with elastomeric pump, intraperitoneal topical instillation of Levobupivacaine, and intraperitoneal aerosolization of Levobupivacaine', 'laparoscopic cholecystectomy', 'levobupivacaine']","['postoperative analgesic assistance', 'shorter operating time', 'Laparoscopic cholecystectomy, Postoperative pain, Stones', 'pain control', 'Pain control', 'postoperative pain', 'pain']","[{'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",183.0,0.0163192,"Eight hours after surgery in groups 2 and 3, there was an increase in pain compared to patients in the first group.","[{'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Cianci', 'Affiliation': ''}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Tartaglia', 'Affiliation': ''}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Fersini', 'Affiliation': ''}, {'ForeName': 'Cassano', 'Initials': 'C', 'LastName': 'Dario', 'Affiliation': ''}, {'ForeName': 'Petta', 'Initials': 'P', 'LastName': 'Rocco', 'Affiliation': ''}, {'ForeName': 'Menga', 'Initials': 'M', 'LastName': 'Rosaria', 'Affiliation': ''}, {'ForeName': 'Vincenzo Neri', 'Initials': 'VN', 'LastName': 'Full', 'Affiliation': ''}, {'ForeName': 'Antonio Ambrosi', 'Initials': 'AA', 'LastName': 'Full', 'Affiliation': ''}]",Annali italiani di chirurgia,[]
2281,32527692,Five-year Survival Prediction and Safety Outcomes with Enzalutamide in Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer from the PREVAIL Trial.,"BACKGROUND


In the PREVAIL study, enzalutamide significantly improved clinical outcomes versus placebo in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC).
OBJECTIVE


To evaluate long-term benefits and risks of enzalutamide in the final prespecified PREVAIL analysis.
DESIGN, SETTING, AND PARTICIPANTS


We conducted a final 5-yr survival analysis of PREVAIL in men with chemotherapy-naïve mCRPC from the enzalutamide (n = 689) and placebo (n = 693) arms.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Predictors of the primary outcome of overall survival were estimated using the Kaplan-Meier method. Long-term adverse events over time were analyzed.
RESULTS AND LIMITATIONS


At the 5-yr data cutoff, 1382 of 1717 (80%) men had died. Enzalutamide reduced the hazard of death by 17% (hazard ratio 0.83; 95% confidence interval [CI] 0.75-0.93; p < 0.001), despite 65%, 54%, and 43% of placebo-treated patients receiving subsequent docetaxel, abiraterone, and enzalutamide, respectively. Median overall survival was 36 mo (95% CI 34-38) in the enzalutamide arm versus 31 mo (95% CI 29-34) in the placebo arm, with a median follow-up of 69 mo. Prognostic modeling showed 5-yr survival rates of 42%, 24%, and 5% for low-, intermediate-, and high-risk groups, respectively. Greater degrees of confirmed prostate-specific antigen declines (≤3 mo) were associated with greater 5-yr survival. A higher incidence of fatal treatment-emergent adverse events was observed with enzalutamide (6.9% vs 3.8%), with an increase in fatal cardiovascular events (1.6% vs 0.4%).
CONCLUSIONS


With >5 yr of follow-up, enzalutamide continued to demonstrate improved survival in patients with mCRPC despite crossover and multiple subsequent effective therapies, balanced against a slightly higher rate of fatal cardiovascular events. PREVAIL is registered on ClinicalTrials.gov as NCT01212991.
PATIENT SUMMARY


We report a maintained long-term survival benefit with enzalutamide and risks with >5 yr of enzalutamide treatment and follow-up in men with metastatic prostate cancer, and identify groups of men with widely different outcomes based on clinical factors.",2020,"Enzalutamide reduced the hazard of death by 17% (hazard ratio 0.83; 95% confidence interval [CI] 0.75-0.93; p < 0.001), despite 65%, 54%, and 43% of placebo-treated patients receiving subsequent docetaxel, abiraterone, and enzalutamide, respectively.","['n\u2009=\u2009693) arms', 'patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC', 'men with chemotherapy-naïve mCRPC from the enzalutamide (n\u2009=\u2009689) and', 'men with metastatic prostate cancer', 'Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer']","['placebo', 'enzalutamide', 'enzalutamide and risks with >5\u2009yr of enzalutamide', 'Enzalutamide']","['5-yr survival', 'Median overall survival', 'hazard of death', 'fatal treatment-emergent adverse events', '5-yr survival rates', 'overall survival', 'survival', 'died', 'rate of fatal cardiovascular events', 'fatal cardiovascular events']","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0936223', 'cui_str': 'Prostate cancer metastatic'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439084', 'cui_str': '>5'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.640042,"Enzalutamide reduced the hazard of death by 17% (hazard ratio 0.83; 95% confidence interval [CI] 0.75-0.93; p < 0.001), despite 65%, 54%, and 43% of placebo-treated patients receiving subsequent docetaxel, abiraterone, and enzalutamide, respectively.","[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Armstrong', 'Affiliation': 'Division of Medical Oncology and Urology, Duke Cancer Institute, Duke University, Durham, NC, USA. Electronic address: andrew.armstrong@duke.edu.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Lin', 'Affiliation': 'Biostatistics, Pfizer Inc., San Francisco, CA, USA.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Tombal', 'Affiliation': 'Urology, Cliniques Universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': ""Division of Urology and Urologic Oncology, Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.""}, {'ForeName': 'Celestia S', 'Initials': 'CS', 'LastName': 'Higano', 'Affiliation': 'Medical Oncology, University of Washington and Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Anthony M', 'Initials': 'AM', 'LastName': 'Joshua', 'Affiliation': ""Department of Medical Oncology, Kinghorn Cancer Centre, St Vincent's Hospital, Sydney, New South Wales, Australia.""}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Parli', 'Affiliation': 'Clinical Development, Pfizer Inc., San Francisco, CA, USA.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Rosbrook', 'Affiliation': 'Biostatistics, Pfizer Inc., San Diego, CA, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'van Os', 'Affiliation': 'Biostatistics, Astellas Pharma Europe BV, Leiden, The Netherlands.'}, {'ForeName': 'Tomasz M', 'Initials': 'TM', 'LastName': 'Beer', 'Affiliation': 'Hematology/Medical Oncology, OHSU Knight Cancer Institute Oregon Health & Science University, Portland, OR, USA.'}]",European urology,['10.1016/j.eururo.2020.04.061']
2282,32527719,Pathobiology and Reversibility of Prediabetes in a Biracial Cohort (PROP-ABC) Study: design of lifestyle intervention.,"INTRODUCTION


Intensive lifestyle intervention (ILI) prevents progression from prediabetes to type 2 diabetes (T2D) but reversal of prediabetes is less well studied.
RESEARCH DESIGN AND METHODS


The overall objectives of the Pathobiology and Reversibility of Prediabetes in a Biracial Cohort (PROP-ABC) Study (ClinicalTrials.gov ID: NCT02027571) are to determine the natural history and reversibility of prediabetes. The study tests specific hypotheses on the patterns of progression to prediabetes among normoglycemic African-American (AA) and European-American (EA) offspring of parents with T2D; emergence of microvascular and macrovascular complications during transition from normal to impaired glucose regulation; significance of the 'metabolically healthy' obese phenotype; and effect of duration of the prediabetic state on its reversibility with lifestyle intervention. Participants who developed incident prediabetes were offered ILI and evaluated quarterly for 5 years. The primary outcome was restoration of normal glucose regulation (fasting plasma glucose <100 mg/dL and two-hour plasma glucose (2hrPG)<140 mg/dL).
RESULTS


Of the 223 subjects enrolled in the PROP-ABC Study, 158 participants with incident prediabetes started ILI. The mean age was 53.3±9.28 years; body mass index 30.6±6.70 kg/m 2 ; 70% were female, 52.4% AA and 47.6% EA. The ILI program used goal setting, weight-based calorie restriction, physical activity (180 min/week), self-monitoring, and meal replacement. Monthly face-to-face (F2F) counseling sessions during the initial 6 months, and quarterly visits thereafter, were supplemented with electronic and postal contacts. Attendance at F2F sessions was highly correlated with weight loss (r=0.98, p<0.0001). Meal replacement induced ~5 kg weight loss within 3 months in participants with recrudescent weight pattern. Self-reported exercise minutes correlated with pedometer step counts (r=0.47, p<0.0001).
CONCLUSION


The PROP-ABC Study has demonstrated the feasibility of executing an ILI program designed to test reversibility of incident prediabetes in a biracial cohort.",2020,"Self-reported exercise minutes correlated with pedometer step counts (r=0.47, p<0.0001).
","['normoglycemic African-American (AA) and European-American (EA) offspring of parents with T2D', '223 subjects enrolled in the PROP-ABC Study, 158 participants with incident prediabetes started ILI', 'The mean age was 53.3±9.28\u2009years; body mass index 30.6±6.70\u2009kg/m 2 ; 70% were female, 52.4% AA and 47.6% EA', 'Participants who developed incident prediabetes were offered ILI and evaluated quarterly for 5\u2009years', 'participants with recrudescent weight pattern']","['Meal replacement', 'lifestyle intervention', 'Intensive lifestyle intervention (ILI']","['restoration of normal glucose regulation (fasting plasma glucose <100\u2009mg/dL and two-hour plasma glucose (2hrPG)<140\u2009mg/dL', 'weight loss']","[{'cui': 'C0580545', 'cui_str': 'Blood glucose normal'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0449261', 'cui_str': 'Reversibility'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]","[{'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0860800', 'cui_str': 'Glucose normal'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",158.0,0.0237108,"Self-reported exercise minutes correlated with pedometer step counts (r=0.47, p<0.0001).
","[{'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Dagogo-Jack', 'Affiliation': 'General Clinical Research Center, The University of Tennessee Health Science Center, Memphis, Tennessee, USA sdj@uthsc.edu.'}, {'ForeName': 'Amy A', 'Initials': 'AA', 'LastName': 'Brewer', 'Affiliation': 'General Clinical Research Center, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Ibiye', 'Initials': 'I', 'LastName': 'Owei', 'Affiliation': 'General Clinical Research Center, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'French', 'Affiliation': 'General Clinical Research Center, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Nkiru', 'Initials': 'N', 'LastName': 'Umekwe', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Rosenthal', 'Affiliation': 'Department of Psychiatry, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Wan', 'Affiliation': 'Department of Preventive Medicine, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2019-000899']
2283,32528046,Author Correction: Vitamin D Supplementation in Overweight/obese Asian Indian Women with Prediabetes Reduces Glycemic Measures and Truncal Subcutaneous Fat: A 78 Weeks Randomized Placebo-Controlled Trial (PREVENT-WIN Trial).,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,2020,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,['Overweight/obese Asian Indian Women with Prediabetes Reduces Glycemic Measures and Truncal Subcutaneous Fat'],"['Placebo', 'Author Correction: Vitamin D Supplementation']",[],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1524069', 'cui_str': 'Indian'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3812881', 'cui_str': 'Author'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]",[],,0.30447,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"[{'ForeName': 'Surya Prakash', 'Initials': 'SP', 'LastName': 'Bhatt', 'Affiliation': 'Diabetes Foundation (India), Safdarjung Development Area, New Delhi, 110016, India.'}, {'ForeName': 'Anoop', 'Initials': 'A', 'LastName': 'Misra', 'Affiliation': 'Diabetes Foundation (India), Safdarjung Development Area, New Delhi, 110016, India. anoopmisra@gmail.com.'}, {'ForeName': 'Ravindra Mohan', 'Initials': 'RM', 'LastName': 'Pandey', 'Affiliation': 'Biostatistics, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Ashish Datt', 'Initials': 'AD', 'LastName': 'Upadhyay', 'Affiliation': 'Biostatistics, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Gulati', 'Affiliation': 'Diabetes Foundation (India), Safdarjung Development Area, New Delhi, 110016, India.'}, {'ForeName': 'Namrata', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'Diabetes Foundation (India), Safdarjung Development Area, New Delhi, 110016, India.'}]",Scientific reports,['10.1038/s41598-020-67064-9']
2284,32533354,"A comparison of nasogastric tube insertion by SORT maneuver (sniffing position, NGT orientation, contralateral rotation, and twisting movement) versus neck flexion lateral pressure in critically ill patients admitted to ICU: a prospective randomized clinical trial.","BACKGROUND


Although many techniques have been introduced to facilitate nasogastric tube (NGT) insertion using anatomic landmarks and a group of devices, there is a lack of general consensus regarding a standard method. The current study purposed to investigate if SORT maneuver (sniffing position, NGT orientation, contralateral rotation, and twisting movement) increases the success rate of NGT correct placement versus neck flexion lateral pressure (NFLP) method.
METHODS


A randomized controlled trial study was conducted in two university affiliated intensive care units (tertiary referral center). Three hundred and ninety-six critically ill patients older than 18 years of age were randomly divided into SORT (n = 200) and NFLP (n = 196) groups. The technique was classified as ""failed"" after the third unsuccessful attempt. Patient characteristics, success rate for the first attempt, time required for the successful first attempt and overall successful insertion time, various complications including kinking, coiling and bleeding and ease of insertion were noted as main outcomes measured.
RESULTS


Ease of insertion was significantly better in the SORT group compared to the NFLP group (P < 0.001). The number of failed attempts was significantly higher in the NFLP group (7.5%) vs the SORT group (3.0%) (P = 0.046). The pattern of complications was not different between two study groups (P = 0.242). The odds of stage II (odds ratio (OR) = 49.9; 95% confidence interval (CI) 25.2 to 98.6), stage III (OR = 67.1; 95% CI 14.9 to 302.8)) and stage IV (OR = 11.8; 95% CI 3.4 to 41.2) ease of insertion were much higher in NFLP compared to SORT group, after adjusting for age and body mass index (BMI). The odds of failure was not significantly different in NFLP group compared to SORT group (OR = 2.3; 95% CI 0.85 to 6.3), after adjusting for age and BMI.
CONCLUSIONS


SORT technique may be considered as a promising method for successful NGT insertions in critically ill patients. However, more trials are needed to confirm the results of this study. The decision must account for individual patient and clinical factors and the operator's experience and preference.
TRIAL REGISTRATION


The study was registered at government registry of clinical trials in Iran (http://www.IRCT.ir) (number: IRCT20091012002582N18, 13 March 2018).",2020,"RESULTS


Ease of insertion was significantly better in the SORT group compared to the NFLP group (P < 0.001).","['two university affiliated intensive care units (tertiary referral center', 'critically ill patients', 'critically ill patients admitted to ICU', 'Three hundred and ninety-six critically ill patients older than 18\xa0years of age']","['nasogastric tube insertion by SORT maneuver (sniffing position, NGT orientation, contralateral rotation, and twisting movement) versus neck flexion lateral pressure', 'IRCT.ir', 'NFLP', 'SORT maneuver (sniffing position, NGT orientation, contralateral rotation, and twisting movement', 'NGT correct placement versus neck flexion lateral pressure (NFLP) method']","['number of failed attempts', 'pattern of complications', 'success rate for the first attempt, time required for the successful first attempt and overall successful insertion time, various complications including kinking, coiling and bleeding and ease of insertion', 'odds of failure']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C5191354', 'cui_str': '396'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0204819', 'cui_str': 'Insertion of nasogastric tube'}, {'cui': 'C1301705', 'cui_str': 'Sniffing position'}, {'cui': 'C0085678', 'cui_str': 'Nasogastric tube'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0445088', 'cui_str': 'Neck flexion'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",396.0,0.120383,"RESULTS


Ease of insertion was significantly better in the SORT group compared to the NFLP group (P < 0.001).","[{'ForeName': 'Sarvin', 'Initials': 'S', 'LastName': 'Sanaie', 'Affiliation': 'Neurosciences Research Center, Aging Research Institute, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Negin', 'Initials': 'N', 'LastName': 'Mirzalou', 'Affiliation': 'Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Shadvar', 'Affiliation': 'Department of Anesthesiology, School of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Samad E J', 'Initials': 'SEJ', 'LastName': 'Golzari', 'Affiliation': 'Department of Anesthesiology, School of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Soleimanpour', 'Affiliation': 'Neurosciences Research Center, Aging Research Institute, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Shamekh', 'Affiliation': 'Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Deepti', 'Initials': 'D', 'LastName': 'Bettampadi', 'Affiliation': 'Department of Cancer Epidemiology, Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Safiri', 'Affiliation': 'Tuberculosis and Lung Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Ata', 'Initials': 'A', 'LastName': 'Mahmoodpoor', 'Affiliation': 'Department of Anesthesiology, School of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran. amahmoodpoor@yahoo.com.'}]",Annals of intensive care,['10.1186/s13613-020-00696-2']
2285,32533380,Effects of endotoxin adsorber hemoperfusion on sublingual microcirculation in patients with septic shock: a randomized controlled trial.,"BACKGROUND


Endotoxins can induce an excessive inflammatory response and result in microcirculatory dysfunction. Polymyxin-B hemoperfusion (PMX-HP) has been recognized to effectively remove endotoxins in patients with sepsis and septic shock, and a rat sepsis model revealed that PMX-HP treatment can maintain a better microcirculation. The primary aim of this study was to investigate the effect of PMX-HP on microcirculation in patients with septic shock.
METHODS


Patients with septic shock were enrolled and randomized to control and PMX-HP groups. In the PMX-HP group, patients received the first session of PMX-HP in addition to conventional septic shock management within 24 h after the onset of septic shock; the second session of PMX-HP was provided after another 24 h as needed.
RESULTS


Overall, 28 patients finished the trial and were analyzed. The mean arterial pressure and norepinephrine infusion dose did not differ significantly between the control and PMX-HP groups after PMX-HP treatment. At 48 h after enrollment, total vessel density (TVD) and perfused vessel density (PVD) were higher in the PMX-HP group than in the control group [TVD 24.2 (22.1-24.9) vs. 21.1 (19.9-22.9) mm/mm 2 ; p = 0.007; PVD 22.9 (20.9-24.9) vs. 20.0 (18.9-21.6) mm/mm 2 , p = 0.008].
CONCLUSIONS


This preliminary study observed that PMX-HP treatment improved microcirculation but not clinical outcomes in patients with septic shock at a low risk of mortality. Nevertheless, larger multicenter trials are needed to confirm the effect of PMX-HP treatment on microcirculation in patients with septic shock at intermediate- and high-risk of mortality. Trial registration ClinicalTrials.gov protocol registration ID: NCT01756755. Date of registration: December 27, 2012. First enrollment: October 6, 2013. https://clinicaltrials.gov/ct2/show/NCT01756755.",2020,The mean arterial pressure and norepinephrine infusion dose did not differ significantly between the control and PMX-HP groups after PMX-HP treatment.,"['Patients with septic shock', 'patients with septic shock', 'patients with sepsis and septic shock', 'patients with septic shock at intermediate- and high-risk of mortality', 'patients with septic shock at a low risk of mortality']","['control and PMX-HP', 'PMX-HP', 'endotoxin adsorber hemoperfusion', 'Polymyxin-B hemoperfusion (PMX-HP']","['total vessel density (TVD) and perfused vessel density (PVD', 'mean arterial pressure and norepinephrine infusion dose', 'sublingual microcirculation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0014264', 'cui_str': 'Bacterial endotoxin'}, {'cui': 'C0019063', 'cui_str': 'Hemoperfusion'}, {'cui': 'C0032535', 'cui_str': 'Polymyxin B'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}]",,0.392238,The mean arterial pressure and norepinephrine infusion dose did not differ significantly between the control and PMX-HP groups after PMX-HP treatment.,"[{'ForeName': 'Shih-Hong', 'Initials': 'SH', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Taipei Tzu Chi Hospital, No. 289, Jianguo Rd., New Taipei, Taiwan.'}, {'ForeName': 'Wing-Sum', 'Initials': 'WS', 'LastName': 'Chan', 'Affiliation': 'Department of Anesthesiology, Far Eastern Memorial Hospital, No. 21, Sec. 2, Nanya S. Rd., New Taipei, Taiwan.'}, {'ForeName': 'Chih-Min', 'Initials': 'CM', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, National Taiwan University Hospital, No 7, Chung Shang South Road, Taipei, Taiwan.'}, {'ForeName': 'Ching-Tang', 'Initials': 'CT', 'LastName': 'Chiu', 'Affiliation': 'Department of Anesthesiology, National Taiwan University Hospital, No 7, Chung Shang South Road, Taipei, Taiwan.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Chao', 'Affiliation': 'Department of Anesthesiology, National Taiwan University Hospital, No 7, Chung Shang South Road, Taipei, Taiwan.'}, {'ForeName': 'Vin-Cent', 'Initials': 'VC', 'LastName': 'Wu', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, No 7, Chung Shang South Road, Taipei, Taiwan.'}, {'ForeName': 'Wang-Huei', 'Initials': 'WH', 'LastName': 'Sheng', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, No 7, Chung Shang South Road, Taipei, Taiwan.'}, {'ForeName': 'Chien-Heng', 'Initials': 'CH', 'LastName': 'Lai', 'Affiliation': 'Department of Surgery, National Taiwan University Hospital, No 7, Chung Shang South Road, Taipei, Taiwan.'}, {'ForeName': 'Ming-Jiuh', 'Initials': 'MJ', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, National Taiwan University Hospital, No 7, Chung Shang South Road, Taipei, Taiwan.'}, {'ForeName': 'Yu-Chang', 'Initials': 'YC', 'LastName': 'Yeh', 'Affiliation': 'Department of Anesthesiology, National Taiwan University Hospital, No 7, Chung Shang South Road, Taipei, Taiwan. tonyyeh@ntuh.gov.tw.'}]",Annals of intensive care,['10.1186/s13613-020-00699-z']
2286,32530814,An Internet-Based Intervention to Alleviate Stress During Social Isolation With Guided Relaxation and Meditation: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Psychophysiological stress and decreased well-being are relevant issues during prolonged social isolation periods. Relaxation practices may represent helpful exercises to cope with anxiety and stressful sensations.
OBJECTIVE


The aim of this research protocol is to test whether remote relaxation practices such as natural sounds, deep respiration, and body scan meditation promote relaxation and improved emotional state and reduce psychomotor activation and the preoccupation related to the coronavirus disease (COVID-19) pandemic.
METHODS


The study population will consist of 3 experimental groups that will randomly receive one of 3 internet-based audio clips containing a single session of guided breathing exercise, guided body scan exercise, or natural sounds. The participants will listen to the fully automated audio clip for 7 minutes and complete pre-post self-assessment scales on their perceived relaxation, psychomotor activation, level of worry associated with COVID-19, and emotional state. At the end of the session, the participants will also be asked to provide qualitative reports on their subjective experiences.
RESULTS


Analyses will be performed to test the differences in the efficacy of the different audio clips in an internet-based intervention on 252 participants (84 per group), investigating whether natural sounds or remote guided practices such as deep respiration and body scan meditation positively enhance the participants' perceived psychological state.
CONCLUSIONS


The study will provide information on if and to what extent guided practices can help in reducing psychological side effects related to social isolation during the COVID-19 pandemic.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/19236.",2020,"RESULTS


Analysis will test the difference in efficacy between audio clips in an internet-based intervention on 252 subjects (84 per group), investigating whether natural sounds or remote guided practices like deep respiration and body scan enhance in a positive way the perceived psychological state.
",['252 subjects (84 per group'],"['online audio clips containing a single session of guided breathing exercise, guided body scan exercise, or natural sounds', 'audio clips']","['relaxation, psychomotor activation, level of worries associated with COVID-19 and emotional state']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}]","[{'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}]",252.0,0.031618,"RESULTS


Analysis will test the difference in efficacy between audio clips in an internet-based intervention on 252 subjects (84 per group), investigating whether natural sounds or remote guided practices like deep respiration and body scan enhance in a positive way the perceived psychological state.
","[{'ForeName': 'Silvia Maria Francesca', 'Initials': 'SMF', 'LastName': 'Pizzoli', 'Affiliation': 'Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Marzorati', 'Affiliation': 'Applied Research Division for Cognitive and Psychological Science, European Institute of Oncology (Istituto di Ricovero e Cura a Carattere Scientifico), Milan, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Mazzoni', 'Affiliation': 'Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Pravettoni', 'Affiliation': 'Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy.'}]",JMIR research protocols,['10.2196/19236']
2287,32531393,"Erratum to: Britton B, Baker AL, Wolfenden L, Wratten C, Bauer J, Beck AK, McCarter K, Harrowfield J, Isenring E, Tang C, Oldmeadow C, and Carter G. Eating As Treatment (EAT): A Stepped-Wedge, Randomized Controlled Trial of a Health Behavior Change Intervention Provided by Dietitians to Improve Nutrition in Patients With Head and Neck Cancer Undergoing Radiation Therapy (TROG 12.03). Int J Radiat Oncol Biol Phys 2019.",,2020,,['Patients With Head and Neck Cancer Undergoing Radiation Therapy'],['Health Behavior Change Intervention Provided by Dietitians to Improve Nutrition'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}]",[],,0.0400018,,[],"International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.03.010']
2288,32531428,Impact of acute inflammation on the extinction of aversive gut memories.,"Impaired extinction of pain-related fear memories can lead to persistent or resurging fear of pain, contributing to the development and maintenance of chronic pain conditions. The mechanisms underlying maladaptive pain-related learning and memory processes remain incompletely understood, particularly in the context of interoceptive, visceral pain. Inflammation is known to interfere with learning and memory, but its effects on the extinction of pain-related fear memories have never been tested. In a randomized, double-blind, placebo-controlled study, we assessed the impact of experimental acute inflammation on the extinction and reinstatement of conditioned visceral pain-related fear. Forty healthy male volunteers underwent differential fear conditioning with visceral pain as clinically relevant unconditioned stimulus (US). Participants then received an intravenous injection of either 0.8 ng/kg lipopolysaccharide (LPS) as inflammatory stimulus or physiological saline as placebo, and extinction training was conducted at the peak of the inflammatory response. Extinction recall and reinstatement test were performed after overnight consolidation. Results showed that visceral pain represents an effective US, eliciting pronounced conditioned pain-related fear responses. Repeated unreinforced presentation of the pain-predictive cue during extinction training resulted in full extinction of the conditioned behavioral response. However, unexpected re-exposure to the US during reinstatement test resulted in return of fear. Despite pronounced LPS-induced effects on inflammatory markers, cortisol, and negative affect, we did not find evidence that acute inflammation resulted in altered fear extinction. The findings support the notion that visceral pain-related fear learning establishes a robust aversive memory trace that remains preserved during inhibitory learning, leaving a latent vulnerability for the return of fear. Inflammation during inhibitory learning did neither weaken nor further amplify this aversive memory trace, suggesting that it is rather resistant to acute inflammation-induced effects, at least in healthy individuals with no additional vulnerability factors.",2020,"Inflammation during inhibitory learning did neither weaken nor further amplify this aversive memory trace, suggesting that it is rather resistant to acute inflammation-induced effects, at least in healthy individuals with no additional vulnerability factors.","['Forty healthy male volunteers', 'healthy individuals with no additional vulnerability factors']","['intravenous injection of either 0.8ng/kg lipopolysaccharide (LPS) as inflammatory stimulus or physiological saline as placebo, and extinction training', 'extinction training', 'differential fear conditioning with visceral pain as clinically relevant unconditioned stimulus (US', 'placebo']","['full extinction of the conditioned behavioral response', 'return of fear', 'conditioned pain-related fear responses', 'extinction of aversive gut memories']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]","[{'cui': 'C0021494', 'cui_str': 'Intravenous injection'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0234245', 'cui_str': 'Visceral pain'}, {'cui': 'C0234403', 'cui_str': 'Unconditioned stimulus'}]","[{'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",40.0,0.101091,"Inflammation during inhibitory learning did neither weaken nor further amplify this aversive memory trace, suggesting that it is rather resistant to acute inflammation-induced effects, at least in healthy individuals with no additional vulnerability factors.","[{'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Benson', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Rebernik', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pastoors', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Brinkhoff', 'Affiliation': 'Department of Nephrology, University Hospital Essen, University of Duisburg-Essen, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Wegner', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Germany; Department of Orthopaedics, Trauma and Reconstructive Surgery, Marienhospital Mülheim an der Ruhr, Germany.'}, {'ForeName': 'Sigrid', 'Initials': 'S', 'LastName': 'Elsenbruch', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Germany; Department of Medical Psychology and Medical Sociology, Ruhr University Bochum, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Engler', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Germany. Electronic address: harald.engler@uk-essen.de.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2020.06.009']
2289,32531622,Comparison of functional outcomes of cartilage tympanoplasty with silastic sheet versus Gelfoam packing in middle ear.,"BACKGROUND AND AIM


Tympanoplasty is a common surgery in otorhinolaryngology field. In majority of procedures, in addition to the graft used for closure of tympanic membrane, a packing material is essential to be placed in the middle ear cavity. The main goals of packing can be summarized as providing support to the tympanic membrane and ossicular grafts, aeration of middle ear cavity and hemostasis. Several packing materials are currently available for using in middle ear surgeries. Each agent is associated with particular advantages and disadvantages, so choosing the proper packing agent is essential in tympanoplasty surgeries. In this study we aimed to compare two common packing materials (Gelfoam and silastic sheets) in cartilage tympanoplasty surgeries.
METHODS AND MATERIALS


In this block-randomized clinical trial, 78 patients undergoing tympanoplasty in Vali-e-asr hospital in 2017 and 2018 were enrolled. They were randomly assigned to silastic sheet or gelfoam groups. The functional outcomes were compared between the groups. Statistical analysis was performed by SPSS.
RESULTS


Success was achieved in 32 (82.1%) patients and 34 (87.2%) patients in gelfoam and silastic sheets' groups, respectively (p = 0.530). The perforation area percentage was significantly lower (P = 0.007) in Gelfoam group. The other parameters were statistically the same in both groups (P > 0.05).
CONCLUSION


Overall, Gelfoam and silastic sheet methods had similar efficacy in cartilage tympanoplasty. Using each method depends on the preferrence of surgeon and patients' characteristics. Multi-center studies with larger sample sizes are needed for more conclusive results.",2020,The perforation area percentage was significantly lower (P = 0.007) in Gelfoam group.,"['78 patients undergoing tympanoplasty in Vali-e-asr hospital in 2017 and 2018 were enrolled', 'middle ear']","['packing materials (Gelfoam and silastic sheets', 'cartilage tympanoplasty with silastic sheet versus Gelfoam packing', 'silastic sheet or gelfoam']","['Success', 'perforation area percentage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0013455', 'cui_str': 'Middle ear structure'}]","[{'cui': 'C1289829', 'cui_str': 'Packing material'}, {'cui': 'C0918040', 'cui_str': 'Gelfoam'}, {'cui': 'C0074517', 'cui_str': 'Silastic'}, {'cui': 'C0439643', 'cui_str': 'Sheets'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}]","[{'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",78.0,0.0554288,The perforation area percentage was significantly lower (P = 0.007) in Gelfoam group.,"[{'ForeName': 'Mahtab Rabbani', 'Initials': 'MR', 'LastName': 'Anari', 'Affiliation': 'Otorhinolaryngology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir Miratashi', 'Initials': 'AM', 'LastName': 'Yazdi', 'Affiliation': 'Surgery Department, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Kazemi', 'Affiliation': 'Otorhinolaryngology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Atie', 'Initials': 'A', 'LastName': 'Moghtadaie', 'Affiliation': 'Internal Medicine Department, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Abolfazl', 'Initials': 'A', 'LastName': 'Farbod', 'Affiliation': 'School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Emami', 'Affiliation': 'Otorhinolaryngology Research Center, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: hd_emami@yahoo.com.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102588']
2290,32531968,Influence of Music on Closed Motor Skills: A Controlled Study with Novice Female Dart-Throwers.,"The influence of music heard at different tempos is analyzed during the execution of a dart-throwing task. The sample consisted of 56 female university students (Mean age = 23.38, SD = 6.773). The participants were randomly assigned to GC (group control without music;  n  = 18), GS (group with slow-paced music at a tempo of 60 BPM;  n  = 19) and GF (group with fast-paced music at a tempo of 105 BPM;  n  = 19). All participants performed a dart-throwing task in two phases. Analysis of the scores obtained during Phase 1 and Phase 2 of dart throwing (examining both between-group differences and within-group differences, i.e., changes in scores from Phase 1 to Phase 2 using a mixed factorial ANOVA) revealed no differences in dart-throwing scores. There were, however, differences in execution time, where the participants in GS needed more time to complete the task than those in GF ( F (2 , 55)  = 4.426,  p  = 0.017) with a large effect size ( ŋ 2 p  = 0.143), although neither of these groups differed from GC. The results are discussed in terms of the role of music in precision tasks and the synchronization of the task with the pace of the music .",2020,"There were, however, differences in execution time, where the participants in GS needed more time to complete the task than those in GF ( F (2 , 55)  = 4.426,  p  = 0.017) with a large effect size ( ŋ 2 p  = 0.143), although neither of these groups differed from GC.","['56 female university students (Mean age = 23.38, SD = 6.773', 'Novice Female Dart-Throwers']","['GC', 'Music', 'GS (group with slow-paced music at a tempo of 60 BPM;  n  = 19) and GF (group with fast-paced music']","['Closed Motor Skills', 'execution time']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336707', 'cui_str': 'Dart'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0076082', 'cui_str': 'tempamine'}, {'cui': 'C0439385', 'cui_str': 'beats/min'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]","[{'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C1278561', 'cui_str': 'Judicial execution'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0510927,"There were, however, differences in execution time, where the participants in GS needed more time to complete the task than those in GF ( F (2 , 55)  = 4.426,  p  = 0.017) with a large effect size ( ŋ 2 p  = 0.143), although neither of these groups differed from GC.","[{'ForeName': 'Félix', 'Initials': 'F', 'LastName': 'Arbinaga', 'Affiliation': 'Department of Clinical and Experimental Psychology, Faculty of Education, Psychology and Sports Science, University of Huelva, 21007 Huelva, Spain.'}, {'ForeName': 'Nehemías', 'Initials': 'N', 'LastName': 'Romero-Pérez', 'Affiliation': 'Department of Social, Evolutionary and Educational Psychology, Faculty of Education, Psychology and Sports Science, University of Huelva, 21007 Huelva, Spain.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Torres-Rosado', 'Affiliation': 'Department of Clinical and Experimental Psychology, Faculty of Education, Psychology and Sports Science, University of Huelva, 21007 Huelva, Spain.'}, {'ForeName': 'Eduardo J', 'Initials': 'EJ', 'LastName': 'Fernández-Ozcorta', 'Affiliation': 'Department of Physical Activity and Sports, Center for University Studies Cardenal Spínola CEU, University of Seville Attached Centre, 41930 Sevilla, Spain.'}, {'ForeName': 'María Isabel', 'Initials': 'MI', 'LastName': 'Mendoza-Sierra', 'Affiliation': 'Department of Social, Evolutionary and Educational Psychology, Faculty of Education, Psychology and Sports Science, University of Huelva, 21007 Huelva, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17114146']
2291,32531982,"Intestinal Permeability in Children with Celiac Disease after the Administration of Oligofructose-Enriched Inulin into a Gluten-Free Diet-Results of a Randomized, Placebo-Controlled, Pilot Trial.","Abnormalities in the intestinal barrier are a possible cause of celiac disease (CD) development. In animal studies, the positive effect of prebiotics on the improvement of gut barrier parameters has been observed, but the results of human studies to date remain inconsistent. Therefore, this study aimed to evaluate the effect of twelve-week supplementation of a gluten-free diet (GFD) with prebiotic oligofructose-enriched inulin (10 g per day) on the intestinal permeability in children with CD treated with a GFD. A pilot, randomized, placebo-controlled nutritional intervention was conducted in 34 children with CD, being on a strict GFD. Sugar absorption test (SAT) and the concentrations of intestinal permeability markers, such as zonulin, intestinal fatty acid-binding protein, claudin-3, calprotectin, and glucagon-like peptide-2, were measured. We found that the supplementation with prebiotic did not have a substantial effect on barrier integrity. Prebiotic intake increased excretion of mannitol, which may suggest an increase in the epithelial surface. Most children in our study seem to have normal values for intestinal permeability tests before the intervention. For individuals with elevated values, improvement in calprotectin and SAT was observed after the prebiotic intake. This preliminary study suggests that prebiotics may have an impact on the intestinal barrier, but it requires confirmation in studies with more subjects with ongoing leaky gut.",2020,"Sugar absorption test (SAT) and the concentrations of intestinal permeability markers, such as zonulin, intestinal fatty acid-binding protein, claudin-3, calprotectin, and glucagon-like peptide-2, were measured.","['subjects with ongoing leaky gut', 'children with CD treated with a GFD', '34 children with CD, being on a strict GFD', 'Children with Celiac Disease after the Administration of Oligofructose-Enriched Inulin into a Gluten-Free Diet']","['placebo-controlled nutritional intervention', 'Placebo', 'gluten-free diet (GFD) with prebiotic oligofructose-enriched inulin']","['calprotectin and SAT', 'Intestinal Permeability', 'barrier integrity', 'Sugar absorption test (SAT) and the concentrations of intestinal permeability markers, such as zonulin, intestinal fatty acid-binding protein, claudin-3, calprotectin, and glucagon-like peptide-2']","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007570', 'cui_str': 'Celiac disease'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0344351', 'cui_str': 'Gluten free diet'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0907858', 'cui_str': 'oligofructose'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0344351', 'cui_str': 'Gluten free diet'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0907858', 'cui_str': 'oligofructose'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}]","[{'cui': 'C0950624', 'cui_str': 'Calprotectin'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0914216', 'cui_str': 'zonulin'}, {'cui': 'C0163314', 'cui_str': 'Intestinal Fatty Acid-Binding Protein'}, {'cui': 'C0912332', 'cui_str': 'Glucagon-like peptide 2'}]",34.0,0.205677,"Sugar absorption test (SAT) and the concentrations of intestinal permeability markers, such as zonulin, intestinal fatty acid-binding protein, claudin-3, calprotectin, and glucagon-like peptide-2, were measured.","[{'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Drabińska', 'Affiliation': 'Department of Chemistry and Biodynamics of Food, Institute of Animal Reproduction and Food Research of Polish Academy of Sciences, 10-748 Olsztyn, Poland.'}, {'ForeName': 'Urszula', 'Initials': 'U', 'LastName': 'Krupa-Kozak', 'Affiliation': 'Department of Chemistry and Biodynamics of Food, Institute of Animal Reproduction and Food Research of Polish Academy of Sciences, 10-748 Olsztyn, Poland.'}, {'ForeName': 'Elżbieta', 'Initials': 'E', 'LastName': 'Jarocka-Cyrta', 'Affiliation': 'Department of Pediatrics, Gastroenterology, and Nutrition, Collegium Medicum, University of Warmia & Mazury, 10-719 Olsztyn, Poland.'}]",Nutrients,['10.3390/nu12061736']
2292,32531990,Changes in Plasma Itaconate Elevation in Early Rheumatoid Arthritis Patients Elucidates Disease Activity Associated Macrophage Activation.,"Changes in the plasma metabolic profile were characterised in newly diagnosed rheumatoid arthritis (RA) patients upon commencement of conventional disease-modifying anti-rheumatic drug (cDMARD) therapy. Plasma samples collected in an early RA randomised strategy study (NCT00920478) that compared clinical (DAS) disease activity assessment with musculoskeletal ultrasound assessment (MSUS) to drive treatment decisions were subjected to untargeted metabolomic analysis. Metabolic profiles were collected at pre- and three months post-commencement of nonbiologic cDMARD. Metabolites that changed in association with changes in the DAS44 score were identified at the three-month timepoint. A total of nine metabolites exhibited a clear correlation with a reduction in DAS44 score following cDMARD commencement, particularly itaconate, its derived anhydride and a derivative of itaconate CoA. Increasing itaconate correlated with improved DAS44 score and decreasing levels of C-reactive protein (CRP). cDMARD treatment effects invoke consistent changes in plasma detectable metabolites, that in turn implicate clinical disease activity with macrophages. Such changes inform RA pathogenesis and reveal for the first time a link between itaconate production and resolution of inflammatory disease in humans. Quantitative metabolic biomarker-based tests of clinical change in state are feasible and should be developed around the itaconate pathway.",2020,"A total of nine metabolites exhibited a clear correlation with a reduction in DAS44 score following cDMARD commencement, particularly itaconate, its derived anhydride and a derivative of itaconate CoA. Increasing itaconate correlated with improved DAS44 score and decreasing levels of C-reactive protein (CRP).",['Early Rheumatoid Arthritis Patients'],['musculoskeletal ultrasound assessment (MSUS'],"['DAS44 score', 'Metabolic profiles', 'plasma metabolic profile', 'DAS44 score and decreasing levels of C-reactive protein (CRP', 'Plasma Itaconate Elevation']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0124235', 'cui_str': 'itaconate'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]",9.0,0.0271239,"A total of nine metabolites exhibited a clear correlation with a reduction in DAS44 score following cDMARD commencement, particularly itaconate, its derived anhydride and a derivative of itaconate CoA. Increasing itaconate correlated with improved DAS44 score and decreasing levels of C-reactive protein (CRP).","[{'ForeName': 'Rónán', 'Initials': 'R', 'LastName': 'Daly', 'Affiliation': 'Glasgow Polyomics, University of Glasgow, Glasgow G61 1BD, UK.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Blackburn', 'Affiliation': 'Glasgow Polyomics, University of Glasgow, Glasgow G61 1BD, UK.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Best', 'Affiliation': 'Institute of Infection, Immunity and Inflammation, University of Glasgow, 120 University Place, Glasgow G12 8TA, UK.'}, {'ForeName': 'Carl S', 'Initials': 'CS', 'LastName': 'Goodyear', 'Affiliation': 'Institute of Infection, Immunity and Inflammation, University of Glasgow, 120 University Place, Glasgow G12 8TA, UK.'}, {'ForeName': 'Manikhandan', 'Initials': 'M', 'LastName': 'Mudaliar', 'Affiliation': 'Glasgow Polyomics, University of Glasgow, Glasgow G61 1BD, UK.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Burgess', 'Affiliation': 'Glasgow Polyomics, University of Glasgow, Glasgow G61 1BD, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Stirling', 'Affiliation': 'Department of Rheumatology, Gartnavel General Hospital, Glasgow G12 0YN, UK.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Porter', 'Affiliation': 'Institute of Infection, Immunity and Inflammation, University of Glasgow, 120 University Place, Glasgow G12 8TA, UK.'}, {'ForeName': 'Iain B', 'Initials': 'IB', 'LastName': 'McInnes', 'Affiliation': 'Institute of Infection, Immunity and Inflammation, University of Glasgow, 120 University Place, Glasgow G12 8TA, UK.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Barrett', 'Affiliation': 'Glasgow Polyomics, University of Glasgow, Glasgow G61 1BD, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dale', 'Affiliation': 'Institute of Infection, Immunity and Inflammation, University of Glasgow, 120 University Place, Glasgow G12 8TA, UK.'}]",Metabolites,['10.3390/metabo10060241']
2293,32532035,Anti-Inflammatory Potential of n-3 Polyunsaturated Fatty Acids Enriched Hen Eggs Consumption in Improving Microvascular Endothelial Function of Healthy Individuals-Clinical Trial.,"The effects of consumption of n-3 polyunsaturated fatty acids (n-3 PUFAs) enriched hen eggs on endothelium-dependent and endothelium-independent vasodilation in microcirculation, and on endothelial activation and inflammation were determined in young healthy individuals. Control group ( N  = 21) ate three regular hen eggs/daily (249 mg n-3 PUFAs/day), and n-3 PUFAs group ( N  = 19) ate three n-3 PUFAs enriched hen eggs/daily (1053 g n-3 PUFAs/day) for 3 weeks. Skin microvascular blood flow in response to iontophoresis of acetylcholine (AChID; endothelium-dependent) and sodium nitroprusside (SNPID; endothelium-independent) was assessed by laser Doppler flowmetry. Blood pressure (BP), body composition, body fluid status, serum lipid and free fatty acids profile, and inflammatory and endothelial activation markers were measured before and after respective dietary protocol. Results: Serum n-3 PUFAs concentration significantly increased, AChID significantly improved, and SNPID remained unchanged in n-3 PUFAs group, while none was changed in Control group. Interferon-γ (pro-inflammatory) significantly decreased and interleukin-10 (anti-inflammatory) significantly increased in n-3 PUFAs. BP, fat free mass, and total body water significantly decreased, while fat mass, interleukin-17A (pro-inflammatory), interleukin-10 and vascular endothelial growth factor A significantly increased in the Control group. Other measured parameters remained unchanged in both groups. Favorable anti-inflammatory properties of n-3 PUFAs consumption potentially contribute to the improvement of microvascular endothelium-dependent vasodilation in healthy individuals.",2020,Interferon-γ (pro-inflammatory) significantly decreased and interleukin-10 (anti-inflammatory) significantly increased in n-3 PUFAs.,"['young healthy individuals', 'Healthy Individuals-Clinical Trial', 'healthy individuals']","['n-3 PUFAs consumption', 'Control group ( N  = 21) ate three regular hen eggs/daily (249 mg n-3 PUFAs/day), and n-3 PUFAs group ( N  = 19) ate three n-3 PUFAs enriched hen eggs/daily (1053', 'acetylcholine', 'n-3 polyunsaturated fatty acids (n-3 PUFAs', 'Interferon-γ', 'n-3 Polyunsaturated Fatty Acids Enriched Hen Eggs Consumption']","['Blood pressure (BP), body composition, body fluid status, serum lipid and free fatty acids profile, and inflammatory and endothelial activation markers', 'interleukin-10 (anti-inflammatory', 'BP, fat free mass, and total body water significantly decreased, while fat mass, interleukin-17A (pro-inflammatory), interleukin-10 and vascular endothelial growth factor A', 'Microvascular Endothelial Function', 'Serum n-3 PUFAs concentration', 'Skin microvascular blood flow', 'SNPID']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0440466', 'cui_str': ""Hen's egg""}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0412472', 'cui_str': 'Total body water measurement'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1701790', 'cui_str': 'IL17A protein, human'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}]",,0.0187711,Interferon-γ (pro-inflammatory) significantly decreased and interleukin-10 (anti-inflammatory) significantly increased in n-3 PUFAs.,"[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Stupin', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine Osijek, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Mihalj', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine Osijek, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Nikolina', 'Initials': 'N', 'LastName': 'Kolobarić', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine Osijek, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Petar', 'Initials': 'P', 'LastName': 'Šušnjara', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine Osijek, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Luka', 'Initials': 'L', 'LastName': 'Kolar', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine Osijek, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Zrinka', 'Initials': 'Z', 'LastName': 'Mihaljević', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine Osijek, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Matić', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine Osijek, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Stupin', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine Osijek, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Jukić', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine Osijek, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Zlata', 'Initials': 'Z', 'LastName': 'Kralik', 'Affiliation': 'Scientific Center of Excellence for Personalized Health Care, Josip Juraj Strossmayer University of Osijek, Trg Svetog Trojstva 3, Hr-31000 Osijek, Croatia.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Grčević', 'Affiliation': 'Scientific Center of Excellence for Personalized Health Care, Josip Juraj Strossmayer University of Osijek, Trg Svetog Trojstva 3, Hr-31000 Osijek, Croatia.'}, {'ForeName': 'Gordana', 'Initials': 'G', 'LastName': 'Kralik', 'Affiliation': 'Scientific Center of Excellence for Personalized Health Care, Josip Juraj Strossmayer University of Osijek, Trg Svetog Trojstva 3, Hr-31000 Osijek, Croatia.'}, {'ForeName': 'Vatroslav', 'Initials': 'V', 'LastName': 'Šerić', 'Affiliation': 'Department of Clinical Laboratory Diagnostics, Osijek University Hospital, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Drenjančević', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine Osijek, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}]",International journal of molecular sciences,['10.3390/ijms21114149']
2294,32532221,Perturbation-based balance training targeting both slip- and trip-induced falls among older adults: a randomized controlled trial.,"BACKGROUND


Falls are the leading cause of injuries among older adults. Perturbation-based balance training (PBT) is an innovative approach to fall prevention that aims to improve the reactive balance response following perturbations such as slipping and tripping. Many of these PBT studies have targeted reactive balance after slipping or tripping, despite both contributing to a large proportion of older adult falls. The goal of this randomized controlled trial was to evaluate the effects of PBT targeting slipping and tripping on laboratory-induced slips and trips. To build upon prior work, the present study included: 1) a control group; 2) separate training and assessment sessions; 3) PBT methods potentially more amenable for use outside the lab compared to methods employed elsewhere, and 4) individualized training for older adult participants.
METHODS


Thirty-four community-dwelling, healthy older adults (61-75 years) were assigned to PBT or a control intervention using minimization. Using a parallel design, reactive balance (primary outcome) and fall incidence were assessed before and after four sessions of BRT or a control intervention involving general balance exercises. Assessments involved exposing participants to an unexpected laboratory-induced slip or trip. Reactive balance and fall incidence were compared between three mutually-exclusive groups: 1) baseline participants who experienced a slip (or trip) before either intervention, 2) post-control participants who experienced a slip (or trip) after the control intervention, and 3) post-PBT participants who experienced a slip (or trip) after PBT. Neither the participants nor investigators were blinded to group assignment.
RESULTS


All 34 participants completed all four sessions of their assigned intervention, and all 34 participants were analyzed. Regarding slips, several measures of reactive balance were improved among post-PBT participants when compared to baseline participants or post-control participants, and fall incidence among post-PBT participants (18%) was lower than among baseline participants (80%). Regarding trips, neither reactive balance nor fall incidence differed between groups.
CONCLUSIONS


PBT targeting slipping and tripping improved reactive balance and fall incidence after laboratory-induced slips. Improvements were not observed after laboratory-induced trips. The disparity in efficacy between slips and trip may have resulted from differences in dosage and specificity between slip and trip training.
TRIAL REGISTRATION


Name of Clinical Trial Registry: clinicaltrials.gov Trial Registration number: NCT04308239. Date of Registration: March 13, 2020 (retrospectively registered).",2020,"Regarding slips, several measures of reactive balance were improved among post-PBT participants when compared to baseline participants or post-control participants, and fall incidence among post-PBT participants (18%) was lower than among baseline participants (80%).","['older adult participants', 'older adults', 'All 34 participants completed all four sessions of their assigned intervention, and all 34 participants were analyzed', 'Thirty-four community-dwelling, healthy older adults (61-75\u2009years', 'participants who experienced a slip (or trip) before either intervention, 2) post-control participants who experienced a slip (or trip) after the control intervention, and 3) post-PBT participants who experienced a slip (or trip) after PBT']","['Perturbation-based balance training targeting both slip- and trip-induced falls', 'Perturbation-based balance training (PBT', 'BRT or a control intervention involving general balance exercises', 'PBT', 'control intervention using minimization', 'separate training and assessment sessions; 3) PBT methods potentially more amenable for use outside the lab compared to methods employed elsewhere, and 4) individualized training']","['reactive balance nor fall incidence', 'reactive balance and fall incidence', 'Reactive balance and fall incidence', 'reactive balance response', 'reactive balance']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}, {'cui': 'C0077275', 'cui_str': 'Triptorelin'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0080024', 'cui_str': 'Piebaldism'}]","[{'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}, {'cui': 'C0077275', 'cui_str': 'Triptorelin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0080024', 'cui_str': 'Piebaldism'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0014003', 'cui_str': 'Employment'}]","[{'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",34.0,0.155587,"Regarding slips, several measures of reactive balance were improved among post-PBT participants when compared to baseline participants or post-control participants, and fall incidence among post-PBT participants (18%) was lower than among baseline participants (80%).","[{'ForeName': 'Leigh J', 'Initials': 'LJ', 'LastName': 'Allin', 'Affiliation': 'Department of Biomedical Engineering and Mechanics, Virginia Tech, Blacksburg, VA, USA.'}, {'ForeName': 'P Gunnar', 'Initials': 'PG', 'LastName': 'Brolinson', 'Affiliation': 'Edward Via College of Osteopathic Medicine, Blacksburg, VA, USA.'}, {'ForeName': 'Briana M', 'Initials': 'BM', 'LastName': 'Beach', 'Affiliation': 'Edward Via College of Osteopathic Medicine, Blacksburg, VA, USA.'}, {'ForeName': 'Sunwook', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Grado Department of Industrial and Systems Engineering, Virginia Tech, 250 Durham Hall (0118), 1145 Perry Street, Blacksburg, VA, USA.'}, {'ForeName': 'Maury A', 'Initials': 'MA', 'LastName': 'Nussbaum', 'Affiliation': 'Grado Department of Industrial and Systems Engineering, Virginia Tech, 250 Durham Hall (0118), 1145 Perry Street, Blacksburg, VA, USA.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Roberto', 'Affiliation': 'Institute for Society, Culture and Environment, Center for Gerontology, Virginia Tech, Blacksburg, VA, USA.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Madigan', 'Affiliation': 'Grado Department of Industrial and Systems Engineering, Virginia Tech, 250 Durham Hall (0118), 1145 Perry Street, Blacksburg, VA, USA. mlm@vt.edu.'}]",BMC geriatrics,['10.1186/s12877-020-01605-9']
2295,32532230,Weekly paclitaxel plus ramucirumab versus weekly nab-paclitaxel plus ramucirumab for unresectable advanced or recurrent gastric cancer with peritoneal dissemination refractory to first-line therapy-the P-SELECT trial (WJOG10617G)-a randomised phase II trial by the West Japan Oncology Group.,"BACKGROUND


Ramucirumab (RAM) with weekly paclitaxel (wPTX) is a standard second-line therapy for advanced or recurrent gastric cancer. Nanoparticle albumin-bound paclitaxel (nab-PTX), an albumin-bound form of PTX, was developed to improve the therapeutic index of taxane treatment. However, the ABSOLUTE trial showed the non-inferiority of weekly nab-PTX (w-nab-PTX) to wPTX with respect to overall survival (OS) as second-line therapy for advanced or recurrent gastric cancer, and subgroup analysis of patients with peritoneal dissemination showed favourable OS and progression-free survival (PFS) in the w-nab-PTX arm compared to those in the wPTX arm. This study evaluated whether w-nab-PTX plus RAM is more effective than wPTX plus RAM for patients with peritoneal dissemination.
METHODS


The P-SELECT trial (WJOG10617G) is a prospective, open-label, multicentre, randomised phase II study evaluating wPTX plus RAM (arm A) versus w-nab-PTX plus RAM (arm B). Key eligibility criteria include the following: 1) histologically proven adenocarcinoma, 2) unresectable or recurrent gastric cancer, 3) peritoneal dissemination, 4) intolerance or refractory to first-line therapy including fluoropyrimidines, and 5) ECOG Performance Status (PS) 0-2. Patients are randomised to either arm at a 1:1 ratio stratified by institution, PS, and severity of ascites. PTX (80 mg/m 2 ; days 1, 8, and 15) and RAM (8 mg/kg; days 1 and 15) are administered every 4 weeks in arm A, while nab-PTX (100 mg/m 2 ; days 1, 8, and 15) instead of PTX is administered in arm B. The primary endpoint is OS, and the main secondary endpoints are PFS, objective response rate, safety, neuropathy-specific quality of life, and biomarkers. To maintain a probability of ≥70% to ensure the hazard ratio for OS in arm B is lower than 0.90, 105 subjects are required. The study was initiated in October 2018 and is being conducted in 58 centres of the West Japan Oncology Group.
DISCUSSION


The results of this study will determine whether w-nab-PTX plus RAM has the potential to be a preferred therapeutic option for advanced and recurrent gastric cancer with peritoneal dissemination, compared to wPTX plus RAM.
TRIAL REGISTRATION


This study was prospectively registered in the Japan Registry of Clinical Trials (jRCTs031180022, October 1, 2018).",2020,"This study evaluated whether w-nab-PTX plus RAM is more effective than wPTX plus RAM for patients with peritoneal dissemination.
","['unresectable advanced or recurrent gastric cancer with peritoneal dissemination refractory to first-line therapy-the P-SELECT trial (WJOG10617G)-a randomised phase II trial by the West Japan Oncology Group', 'patients with peritoneal dissemination', 'Key eligibility criteria include the following: 1) histologically proven adenocarcinoma, 2) unresectable or recurrent gastric cancer, 3) peritoneal dissemination, 4) intolerance or refractory to first-line therapy including fluoropyrimidines, and 5) ECOG Performance Status (PS) 0-2', 'October 2018 and is being conducted in 58 centres of the West Japan Oncology Group', 'advanced or recurrent gastric cancer']","['PTX', 'wPTX plus RAM', 'Nanoparticle albumin-bound paclitaxel (nab-PTX', 'RAM', 'w-nab-PTX plus RAM', 'Ramucirumab (RAM) with weekly paclitaxel (wPTX', 'Weekly paclitaxel plus ramucirumab versus weekly nab-paclitaxel plus ramucirumab']","['favourable OS and progression-free survival (PFS', 'overall survival (OS', 'PFS, objective response rate, safety, neuropathy-specific quality of life, and biomarkers']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278502', 'cui_str': 'Gastric cancer recurrent'}, {'cui': 'C4087504', 'cui_str': 'Peritoneal dissemination'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.108982,"This study evaluated whether w-nab-PTX plus RAM is more effective than wPTX plus RAM for patients with peritoneal dissemination.
","[{'ForeName': 'Kenro', 'Initials': 'K', 'LastName': 'Hirata', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan. kenro916@gmail.com.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Hamamoto', 'Affiliation': 'Keio Cancer Center, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan.'}, {'ForeName': 'Chiyo K', 'Initials': 'CK', 'LastName': 'Imamura', 'Affiliation': 'Department of Clinical Pharmacokinetics and Pharmacodynamics, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Yoshimura', 'Affiliation': 'Center for Integrated Medical Research, Hiroshima University Hospital, Hiroshima University, 1-2-3, Kasumi, Minami-ku, Hiroshima, 734-8551, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Yamazaki', 'Affiliation': 'Department of Gastrointestinal Oncology, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Hironaka', 'Affiliation': 'Department of Medical Oncology and Hematology, Oita University Faculty of Medicine, 1-1 Idaigaoka, Hasama-machi, Yufu-shi, Oita, 879-5593, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, 1-1, Kanokoden, Chikusa-ku, Nagoya-shi, Aichi, Japan.'}]",BMC cancer,['10.1186/s12885-020-07047-1']
2296,32532249,Protocol of changes induced by early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (e-HABIT-ILE) in pre-school children with bilateral cerebral palsy: a multisite randomized controlled trial.,"BACKGROUND


Cerebral palsy (CP), which is the leading cause of motor disability during childhood, can produce sensory and cognitive impairments at different degrees. Most recent therapeutic interventions for these patients have solely focused on upper extremities (UE), although more than 60% of these patients present lower extremities (LE) deficits. Recently, a new therapeutic concept, Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE), has been proposed, involving the constant stimulation of UE and LE. Based on motor skill learning principles, HABIT-ILE is delivered in a day-camp setting, promoting voluntary movements for several hours per day during 10 consecutive week days. Interestingly, the effects of this intervention in a large scale of youngsters are yet to be observed. This is of interest due to the lack of knowledge on functional, neuroplastic and biomechanical changes in infants with bilateral CP. The aim of this randomized controlled study is to assess the effects of HABIT-ILE adapted for pre-school children with bilateral CP regarding functional, neuroplastic and biomechanical factors.
METHODS


This international, multicentric study will include 50 pre-school children with CP from 12 to 60 months of age, comparing the effect of 50 h (2 weeks) of HABIT-ILE versus regular motor activity and/or customary rehabilitation. HABIT-ILE presents structured activities and functional tasks with continuous increase in difficulty while the child evolves. Assessments will be performed at 3 period times: baseline, two weeks later and 3 months later. The primary outcome will be the Gross Motor Function Measure 66. Secondary outcomes will include Both Hands Assessment, Melbourne Assessment-2, Semmes-Weinstein Monofilament Test, algometry assessments, executive function tests, ACTIVLIM-CP questionnaire, Pediatric Evaluation of Disability Inventory (computer adaptative test), Young Children's Participation and Environment Measure, Measure of the Process of Care, Canadian Occupational Performance Measure, neuroimaging and kinematics.
DISCUSSION


The results of this study should highlight the impact of a motor, intensive, goal-directed therapy (HABIT-ILE) in pre-school children at a functional, neuroplastic and biomechanical level. In addition, this changes could demonstrated the impact of this intervention in the developmental curve of each child, improving functional ability, activity and participation in short-, mid- and long-term.
NAME OF THE REGISTRY


Evaluation of Functional, Neuroplastic and Biomechanical Changes Induced by an Intensive, Playful Early-morning Treatment Including Lower Limbs (EARLY-HABIT-ILE) in Preschool Children With Uni and Bilateral Cerebral Palsy (HABIT-ILE).
TRIAL REGISTRATION


NCT04017871 REGISTRATION DATE: July 12, 2019.",2020,"The aim of this randomized controlled study is to assess the effects of HABIT-ILE adapted for pre-school children with bilateral CP regarding functional, neuroplastic and biomechanical factors.
","['pre-school children with bilateral cerebral palsy', 'infants with bilateral CP', 'Cerebral palsy (CP', 'pre-school children at a functional, neuroplastic and biomechanical level', '50 pre-school children with CP from 12 to 60\u2009months of age, comparing the effect of 50\u2009h (2\u2009weeks) of', 'pre-school children with bilateral CP regarding functional, neuroplastic and biomechanical factors', 'Preschool Children With Uni and Bilateral Cerebral Palsy (HABIT-ILE']","['HABIT-ILE versus regular motor activity and/or customary rehabilitation', 'HABIT-ILE', 'early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (e-HABIT-ILE']","['lower extremities (LE) deficits', ""Both Hands Assessment, Melbourne Assessment-2, Semmes-Weinstein Monofilament Test, algometry assessments, executive function tests, ACTIVLIM-CP questionnaire, Pediatric Evaluation of Disability Inventory (computer adaptative test), Young Children's Participation and Environment Measure, Measure of the Process of Care, Canadian Occupational Performance Measure, neuroimaging and kinematics"", 'functional ability, activity and participation in short-, mid- and long-term', 'Gross Motor Function Measure 66']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3838784', 'cui_str': 'Bilateral cerebral palsy'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3853222', 'cui_str': 'Sea urchin - dietary'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0230377', 'cui_str': 'Both hands'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C2585956', 'cui_str': 'Canadian occupational performance measure'}, {'cui': 'C0679575', 'cui_str': 'Neuroimaging'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}]",,0.0546853,"The aim of this randomized controlled study is to assess the effects of HABIT-ILE adapted for pre-school children with bilateral CP regarding functional, neuroplastic and biomechanical factors.
","[{'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Araneda', 'Affiliation': 'Institute of Neuroscience, Université catholique de Louvain, Avenue Mounier 53 box B1.53.04, 1200, Brussels, Belgium.'}, {'ForeName': 'Stephane V', 'Initials': 'SV', 'LastName': 'Sizonenko', 'Affiliation': 'Division of Child Development and Growth, Department of Pediatrics, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Newman', 'Affiliation': 'Paediatric Neurology and Neurorehabilitation Unit, University Hospital of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Mickael', 'Initials': 'M', 'LastName': 'Dinomais', 'Affiliation': 'Département de Médecine Physique et de Réadaptions, CHU Angers-Capucins, Angers, France.'}, {'ForeName': 'Gregoire', 'Initials': 'G', 'LastName': 'Le Gal', 'Affiliation': 'University Hospital of Brest, Brest, France.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Ebner-Karestinos', 'Affiliation': 'Institute of Neuroscience, Université catholique de Louvain, Avenue Mounier 53 box B1.53.04, 1200, Brussels, Belgium.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Paradis', 'Affiliation': 'Department of Developmental Neuroscience, IRCCS Fondazione Stella Maris, Pisa, Italy.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Klöcker', 'Affiliation': 'Institute of Neuroscience, Université catholique de Louvain, Avenue Mounier 53 box B1.53.04, 1200, Brussels, Belgium.'}, {'ForeName': 'Geoffroy', 'Initials': 'G', 'LastName': 'Saussez', 'Affiliation': 'Institute of Neuroscience, Université catholique de Louvain, Avenue Mounier 53 box B1.53.04, 1200, Brussels, Belgium.'}, {'ForeName': 'Josselin', 'Initials': 'J', 'LastName': 'Demas', 'Affiliation': ""Laboratoire Angevin de Recherche en Ingénierie des Systèmes, Université d'Angers, Angers, France.""}, {'ForeName': 'Rodolphe', 'Initials': 'R', 'LastName': 'Bailly', 'Affiliation': 'Pediatric rehabilitation department, Fondation Ildys, Brest, France.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Bouvier', 'Affiliation': 'University Hospital of Brest, Brest, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Nowak', 'Affiliation': 'University Hospital of Brest, Brest, France.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Guzzetta', 'Affiliation': 'Department of Developmental Neuroscience, IRCCS Fondazione Stella Maris, Pisa, Italy.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Riquelme', 'Affiliation': 'Department of Nursing and Physiotherapy and Research Institute on Health Sciences (UINICS-Idisba), University of the Balearic Islands, Palma de Mallorca, Spain.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Brochard', 'Affiliation': 'University Hospital of Brest, Brest, France.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Bleyenheuft', 'Affiliation': 'Institute of Neuroscience, Université catholique de Louvain, Avenue Mounier 53 box B1.53.04, 1200, Brussels, Belgium. yannick.bleyenheuft@uclouvain.be.'}]",BMC neurology,['10.1186/s12883-020-01820-2']
2297,32543706,Recombinant human BMP6 applied within Autologous Blood Coagulum accelerates bone healing: Randomized controlled trial in High Tibial Osteotomy patients.,"BMPs are potent osteogenic proteins that induce new bone formation in vivo. However, their effect on bone healing in the trabecular bone surfaces remains challenging. We evaluated the safety and efficacy of recombinant human BMP6 (rhBMP6) applied within an autologous blood coagulum (ABC) in a surgically created wedge-defect of the proximal tibia in patients undergoing high tibial osteotomy (HTO) for Varus deformity and medial osteoarthritis of the knee. We enrolled 20 HTO patients in a randomized, placebo controlled, double-blinded Phase I/II clinical trial. RhBMP6/ABC (1.0 mg/10 mL ABC prepared from peripheral blood) or placebo (10 mL ABC containing excipients) were administered into the tibial wedge defects. Patients were followed for 0 to 24 months by clinical examination (safety) and CT and serial radiographic analyses (efficacy). The results show that there were no detectable anti-rhBMP6 antibodies in the blood of any of the 20 patients at 14 weeks following implantation. During the 24 months follow-up there were no serious adverse reactions recorded. The CT scans from defects of patients treated with rhBMP6/ABC showed an accelerated bone healing as compared to placebo at 9-weeks (47.8 ± 24.1 vs. 22.2 ± 12.3 mg/cm 2  ; P=0.008) and at 14-weeks (89.7 ± 29.1 vs. 53.6 ± 21.9 mg/cm 2  ; P=0.006) follow-up. Radiographic analyses at weeks 6 and 24, and months 12 and 24, suggested the advanced bone formation and remodelling in rhBMP6/ABC treated patients. In conclusion, we show that rhBMP6/ABC at a dose of 100 μg/mL accelerated bone healing in patients undergoing HTO without serious adverse events and with a good tolerability, as compared to placebo alone. Overall, for the first time, a BMP-based osteogenic implant was examined against a placebo for bone healing efficacy in the trabecular bone surface, using an objective BMD measurement system. This article is protected by copyright. All rights reserved.",2020,The results show that there were no detectable anti-rhBMP6 antibodies in the blood of any of the 20 patients at 14 weeks following implantation.,"['High Tibial Osteotomy patients', 'patients undergoing high tibial osteotomy (HTO) for Varus deformity and medial osteoarthritis of the knee', '20 HTO patients']","['Recombinant human BMP6', 'RhBMP6/ABC ', 'rhBMP6/ABC', 'recombinant human BMP6 (rhBMP6', 'placebo']","['accelerated bone healing', 'clinical examination (safety) and CT and serial radiographic analyses (efficacy', 'bone healing', 'detectable anti-rhBMP6 antibodies', 'advanced bone formation and remodelling']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0187826', 'cui_str': 'Osteotomy of tibia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0432593', 'cui_str': 'Varus angulation'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1612225', 'cui_str': 'BMP6 protein, human'}, {'cui': 'C0302148', 'cui_str': 'Blood clot'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C1321023', 'cui_str': 'Bone healing status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1612225', 'cui_str': 'BMP6 protein, human'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}]",20.0,0.154535,The results show that there were no detectable anti-rhBMP6 antibodies in the blood of any of the 20 patients at 14 weeks following implantation.,"[{'ForeName': 'Catharina', 'Initials': 'C', 'LastName': 'Chiari', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Lovorka', 'Initials': 'L', 'LastName': 'Grgurevic', 'Affiliation': 'Laboratory for Mineralized Tissues, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Salata 11, 10000, Zagreb, Croatia.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Bordukalo-Niksic', 'Affiliation': 'Laboratory for Mineralized Tissues, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Salata 11, 10000, Zagreb, Croatia.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Oppermann', 'Affiliation': 'Genera Research, Svetonedeljska 2, Kalinovica, 10436 Rakov Potok, Croatia.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Valentinitsch', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Nemecek', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Staats', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Schreiner', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Trost', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kolb', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Kainberger', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Sanja', 'Initials': 'S', 'LastName': 'Pehar', 'Affiliation': 'Laboratory for Mineralized Tissues, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Salata 11, 10000, Zagreb, Croatia.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Milosevic', 'Affiliation': 'Department of Environmental and Occupational Health and Sports, School of Public Health ""Andrija Stampar"", University of Zagreb School of Medicine, Rockefellerova 4, 10000, Zagreb, Croatia.'}, {'ForeName': 'Snjezana', 'Initials': 'S', 'LastName': 'Martinovic', 'Affiliation': 'SmartMedico, Zupanova 5, 10000, Zagreb, Croatia.'}, {'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Peric', 'Affiliation': 'Department for intracellular communication, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Salata 3, 10000, Zagreb, Croatia.'}, {'ForeName': 'T Kuber', 'Initials': 'TK', 'LastName': 'Sampath', 'Affiliation': 'perForm Biologics Inc., Holliston, MA, 01746, USA.'}, {'ForeName': 'Slobodan', 'Initials': 'S', 'LastName': 'Vukicevic', 'Affiliation': 'Laboratory for Mineralized Tissues, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Salata 11, 10000, Zagreb, Croatia.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Windhager', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.4107']
2298,32537276,"Visceral Mobilization and Functional Constipation in Stroke Survivors: A Randomized, Controlled, Double-Blind, Clinical Trial.","Introduction Chronic functional constipation is common among stroke survivors. Osteopathy is an effective form of treatment as it acts on the structures surrounding the bowels that may have lost their normal capacity of resilience. The aim of the present study was to evaluate the effect of visceral mobilization on symptoms of functional constipation and static balance in stroke survivors. Materials and methods Thirty stroke survivors met the eligibility criteria and were randomly allocated to a group physical therapy and visceral manipulation or a group physical therapy. Both groups were submitted to conventional physical therapy. The group physical therapy and visceral manipulation was also submitted to visceral mobilization (sphincter inhibition and mobilization of the large intestine), whereas the group physical therapy was submitted to a sham procedure (superficial touching over the intestines). Evaluations were conducted prior to the intervention, immediately after the first intervention session and one week after the end of the five sessions. At each evaluation, the static balance was analyzed using a computerized plantar pressure sensor. Moreover, an intestinal symptoms rating scale was administered during the pre-intervention evaluation, and one week after the end of the intervention. Results Significant improvements were found in intestinal symptoms (frequency of bowel movements, abdominal pain/discomfort, difficulty eliminating stools, sensation of intestinal swelling or distention, difficulty eliminating gas, sensation of incomplete bowel movement and, anal pain during bowel movement) and static balance (anteroposterior sway: F = 82.06, p = 0.0001; velocity of anteroposterior sway: F = 17.6, p = 0.001; and velocity of mediolateral sway: F = 4.41, p = 0.01). Conclusion Visceral mobilization can be part of a neurologic rehabilitation program to improve symptoms of constipation and static balance in stroke survivors.",2020,"Results Significant improvements were found in intestinal symptoms (frequency of bowel movements, abdominal pain/discomfort, difficulty eliminating stools, sensation of intestinal swelling or distention, difficulty eliminating gas, sensation of incomplete bowel movement and, anal pain during bowel movement) and static balance (anteroposterior sway: F = 82.06, p = 0.0001; velocity of anteroposterior sway: F = 17.6, p = 0.001; and velocity of mediolateral sway: F = 4.41, p = 0.01).","['Thirty stroke survivors met the eligibility criteria', 'stroke survivors', 'Stroke Survivors']","['physical therapy and visceral manipulation or a group physical therapy', 'visceral mobilization', 'conventional physical therapy']","['intestinal symptoms (frequency of bowel movements, abdominal pain/discomfort, difficulty eliminating stools, sensation of intestinal swelling or distention, difficulty eliminating gas, sensation of incomplete bowel movement and, anal pain during bowel movement) and static balance', 'intestinal symptoms rating scale', 'Visceral Mobilization and Functional Constipation']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C1571809', 'cui_str': 'Visceral manipulation'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0426642', 'cui_str': 'Frequency of bowel action'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0238637', 'cui_str': 'Anal pain'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0429688', 'cui_str': 'Symptom ratings'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0401146', 'cui_str': 'Constipation - functional'}]",30.0,0.0319127,"Results Significant improvements were found in intestinal symptoms (frequency of bowel movements, abdominal pain/discomfort, difficulty eliminating stools, sensation of intestinal swelling or distention, difficulty eliminating gas, sensation of incomplete bowel movement and, anal pain during bowel movement) and static balance (anteroposterior sway: F = 82.06, p = 0.0001; velocity of anteroposterior sway: F = 17.6, p = 0.001; and velocity of mediolateral sway: F = 4.41, p = 0.01).","[{'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Pasin Neto', 'Affiliation': 'Osteopathy, Brazilian College of Osteopathy, Sorocaba, BRA.'}, {'ForeName': 'Rodolfo A', 'Initials': 'RA', 'LastName': 'Borges', 'Affiliation': 'Osteopathy, Brazilian College of Osteopathy, Sorocaba, BRA.'}]",Cureus,['10.7759/cureus.8058']
2299,32537287,The Impact of Device Innovation on Clinical Outcomes in Expander-based Breast Reconstruction.,"Staged expander-based breast reconstruction represents the most common reconstructive modality in the United States. The introduction of a novel tissue expander with an integrated drain (Sientra AlloX2) holds promise to further improve clinical outcomes.
Methods


Patients who underwent immediate expander-based pre-pectoral breast reconstruction were identified. Two cohorts were created, that is, patients who underwent placement of a conventional tissue expander [133MX (Allergan)] (Group 1) versus AlloX2 (Sientra) (Group 2). The study endpoint was successful completion of expansion with the objective being to investigate differences in outcome following expander placement.
Results


Fifty-eight patients underwent 99 breast reconstructions [Group 1: N = 24 (40 breasts) versus Group 2: N = 34 (59 breast)]. No differences were noted for age ( P  = 0.586), BMI ( P  = 0.109), history of radiation ( P  = 0.377), adjuvant radiotherapy ( P  = 1.00), and overall complication rate ( P  = 0.141). A significantly longer time to drain removal was noted in Group 1 ( P  < 0.001). All patients with postoperative infection in Group 1 required surgical treatment versus successful washout of the peri-prosthetic space via the AlloX2 drain port in 3 of 5 patients in Group 2 ( P  = 0.196). Furthermore, both cases of seroma in Group 1 required image-guided drainage versus in-office drainage via the AlloX2 drain port in 1 patient in Group 2 ( P  =0.333).
Conclusion


The unique feature of the AlloX2 provides surgeons easy access to the peri-prosthetic space without altering any of the other characteristics of a tissue expander. This resulted in a reduced time to drain removal and facilitated management of postoperative seroma and infection.",2019,"No differences were noted for age ( P  = 0.586), BMI ( P  = 0.109), history of radiation ( P  = 0.377), adjuvant radiotherapy ( P  = 1.00), and overall complication rate ( P  = 0.141).","['Expander-based Breast Reconstruction', 'Fifty-eight patients underwent 99 breast reconstructions']","['conventional tissue expander [133MX (Allergan', 'Staged expander-based breast reconstruction', 'Device Innovation', 'AlloX2', 'novel tissue expander with an integrated drain (Sientra AlloX2']","['overall complication rate', 'history of radiation', 'longer time to drain removal', 'BMI']","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0040289', 'cui_str': 'Tissue expander'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0411815', 'cui_str': 'Removal of drain'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",58.0,0.0370862,"No differences were noted for age ( P  = 0.586), BMI ( P  = 0.109), history of radiation ( P  = 0.377), adjuvant radiotherapy ( P  = 1.00), and overall complication rate ( P  = 0.141).","[{'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Momeni', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Stanford University School of Medicine, Stanford, Calif.'}, {'ForeName': 'Alexander Y', 'Initials': 'AY', 'LastName': 'Li', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Stanford University School of Medicine, Stanford, Calif.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Tsai', 'Affiliation': 'Division of General Surgery, Stanford University School of Medicine, Palo Alto, Calif.'}, {'ForeName': 'Derrick', 'Initials': 'D', 'LastName': 'Wan', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Stanford University School of Medicine, Stanford, Calif.'}, {'ForeName': 'Mardi R', 'Initials': 'MR', 'LastName': 'Karin', 'Affiliation': 'Division of General Surgery, Stanford University School of Medicine, Palo Alto, Calif.'}, {'ForeName': 'Irene L', 'Initials': 'IL', 'LastName': 'Wapnir', 'Affiliation': 'Division of General Surgery, Stanford University School of Medicine, Palo Alto, Calif.'}]",Plastic and reconstructive surgery. Global open,['10.1097/GOX.0000000000002524']
2300,32537333,OnabotulinumtoxinA Treatment for Moderate to Severe Forehead Lines: A Review.,"With onabotulinumtoxinA approved for the treatment of glabellar and crow's feet lines and, most recently, for forehead lines (FHL), it is possible to simultaneously treat multiple areas of the upper face that are of high concern and treatment priority for aesthetically oriented individuals. This review aims to present key insights on the use of onabotulinumtoxinA for the treatment of moderate to severe FHL.
Methods


Double-blind, placebo-controlled registration trials of onabotulinumtoxinA for the treatment of FHL were included. Using findings from 3 such published studies, we discuss key concepts and clinical experience for the treatment of moderate to severe FHL with onabotulinumtoxinA (20 U in the frontalis and 20 U in the glabellar complex, with/without 24 U in crow's feet lines), including injection pattern, dose selection, efficacy and safety data, and considerations for patient selection.
Results


Across the 2 pivotal phase 3 studies, responder rates on investigator- and subject-assessed measures of appearance of FHL severity were significantly higher with onabotulinumtoxinA versus placebo for the treatment of FHL at day 30 ( P  < 0.0001), and results were maintained through 3 cycles of onabotulinumtoxinA.
Conclusions


OnabotulinumtoxinA treatment also resulted in high patient satisfaction rates. The incidence of eyebrow and of eyelid ptosis was low, and no new safety signals were detected. OnabotulinumtoxinA is safe and effective and an appropriate option for patients with moderate to severe FHL encountered in clinical practice.",2020,"The incidence of eyebrow and of eyelid ptosis was low, and no new safety signals were detected.","['patients with moderate to severe FHL encountered in clinical practice', 'Moderate to Severe Forehead Lines']","['placebo', 'onabotulinumtoxinA versus placebo', 'OnabotulinumtoxinA', 'onabotulinumtoxinA']","['incidence of eyebrow and of eyelid ptosis', 'appearance of FHL severity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0016540', 'cui_str': 'Forehead structure'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0015420', 'cui_str': 'Eyebrow structure'}, {'cui': 'C0005745', 'cui_str': 'Ptosis of eyelid'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0016540', 'cui_str': 'Forehead structure'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0489554,"The incidence of eyebrow and of eyelid ptosis was low, and no new safety signals were detected.","[{'ForeName': 'Koenraad', 'Initials': 'K', 'LastName': 'De Boulle', 'Affiliation': 'Aalst Dermatology Clinic, Aalst, Belgium.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Carruthers', 'Affiliation': 'Department of Dermatology, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Nowell', 'Initials': 'N', 'LastName': 'Solish', 'Affiliation': 'Department of Surgical Dermatology, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Carruthers', 'Affiliation': 'Department of Dermatology, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Wolfgang G', 'Initials': 'WG', 'LastName': 'Phillipp-Dormston', 'Affiliation': 'Hautzentrum Köln/Cologne Dermatology, Cologne, Germany.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Fagien', 'Affiliation': 'Aesthetic Eyelid Plastic Surgery, Boca Raton, Fla.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Sangha', 'Affiliation': 'Medical Affairs, Aesthetics, Allergan plc, Irvine, Calif.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Silberberg', 'Affiliation': 'Medical Affairs, Aesthetics, Allergan plc, Marlow, Buckinghamshire, United Kingdom.'}, {'ForeName': 'Cheri', 'Initials': 'C', 'LastName': 'Mao', 'Affiliation': 'Clinical Research & Development, Dermatology, Allergan Plc, Irvine, Calif.'}]",Plastic and reconstructive surgery. Global open,['10.1097/GOX.0000000000002669']
2301,32537348,ALGINATE versus NPWT in the Preparation of Surgical Excisions for an STSG: ATEC Trial.,"A calcium alginate dressing (ALGINATE) and negative pressure wound therapy (NPWT) are frequently used to treat wounds which heal by secondary intention. This trial compared the healing efficacy and safety of these 2 treatments.
Methods


This randomized, non-inferiority trial enrolled patients who underwent skin excision (>30 cm 2 ), which was left open to heal by secondary intention. They received ALGINATE or NPWT by a centralized randomization. Follow-up was performed weekly until optimal granulation tissue was obtained. The primary outcome was time to obtain optimal granulation tissue for a split thickness skin graft take (non-inferiority margin: 4 days). Secondary outcomes were occurrence of adverse events (AEs) and impact of the treatments on the patient's daily life.
Results


ALGINATE and NPWT were applied to 47 and 48 patients, respectively. The mean time to optimal granulation was 19.98 days (95% CI, 17.7-22.3) with ALGINATE and 20.54 (95% CI, 17.6-23.5) with NPWT. Between group difference was -0.56 days (95% CI -4.22 to 3.10). The non-inferiority of ALGINATE versus NPWT was demonstrated. No AE related to the treatment occurred with ALGINATE versus 14 AEs with NPWT. There was no difference in the impact of the treatments on the patient's daily life.
Conclusion


This trial demonstrates that ALGINATE has a similar healing efficacy to that of NPWT and that is markedly better with regard to patient safety.",2020,Between group difference was -0.56 days (95% CI -4.22 to 3.10).,"['30\u2009cm 2 ), which was left open to heal by secondary intention']","['skin excision', 'NPWT', 'calcium alginate dressing (ALGINATE) and negative pressure wound therapy (NPWT', 'ALGINATE or NPWT']","[""patient's daily life"", 'healing efficacy and safety', ""occurrence of adverse events (AEs) and impact of the treatments on the patient's daily life"", 'time to obtain optimal granulation tissue for a split thickness skin graft take', 'mean time to optimal granulation']","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]","[{'cui': 'C2697304', 'cui_str': 'Excision of skin'}, {'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0460767', 'cui_str': 'Calcium alginate dressing'}, {'cui': 'C0002040', 'cui_str': 'Alginates'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0018180', 'cui_str': 'Granulation tissue'}, {'cui': 'C0439061', 'cui_str': 'Split thickness skin graft (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.116871,Between group difference was -0.56 days (95% CI -4.22 to 3.10).,"[{'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Casanova', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Hospital Conception, Marseille, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Guerreschi', 'Affiliation': 'Department of Plastic, Cosmetic and Reconstructive Surgery, Regional and University Hospital Centre Lille, Lille, France.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Sinna', 'Affiliation': 'Department of Plastic, Cosmetic and Reconstructive Surgery, University Hospital Centre Amiens-Picardie, Amiens, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bertheuil', 'Affiliation': 'Department of Plastic, Reconstructive and Aesthetic Surgery, University Hospital Centre Rennes, Rennes, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Philandrianos', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Hospital Conception, Marseille, France.'}, {'ForeName': 'Bérengère', 'Initials': 'B', 'LastName': 'Chignon-Sicard', 'Affiliation': 'Department of Plastic, Cosmetic and Reconstructive Surgery, University Hospital Centre Nice, Nice, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Duteille', 'Affiliation': 'Department of Plastic, Cosmetic and Reconstructive Surgery, University Hospital Centre Nantes, Nantes, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Atlan', 'Affiliation': 'Department of Plastic, Cosmetic and Reconstructive Surgery, Hospital Tenon, Paris, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Rousseau', 'Affiliation': 'Department of Plastic, Cosmetic and Reconstructive Surgery, University Hospital Centre Angers, Angers, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Chatellier', 'Affiliation': 'Unité de Recherche Clinique, European Hospital Group Georges-Pompidou, Unité de Recherche Clinique, INSERM, CIC 1418, Paris, France.'}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Boucher', 'Affiliation': 'Department of Burns, Plastic, Cosmetic and Reconstructive Surgery, University Hospital Centre Lyon, Lyon, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Pham Dang', 'Affiliation': 'Department of Maxillofacial and Plastic Surgery, University Hospital Centre Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Adeline', 'Initials': 'A', 'LastName': 'Cambon-Binder', 'Affiliation': 'Department of Orthopaedic and Hand Surgery, Hospital Saint-Antoine, Paris, France.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Michot', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, University Hospital Centre Bordeaux, Bordeaux, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Pluvy', 'Affiliation': 'Department of Plastic Surgery, University Hospital Centre Besancon, Besançon, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Seigle-Murandi', 'Affiliation': 'Department of Plastic, Cosmetic and Reconstructive Surgery, University Hospital Centre Strasbourg, Strasbourg, France.'}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': 'Department of Plastic, Cosmetic and Reconstructive Surgery, University and Regional Hospital Centre Brest, Brest, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Revol', 'Affiliation': 'Department of Plastic, Cosmetic and Reconstructive Surgery, Hospital Tenon, Paris, France.'}]",Plastic and reconstructive surgery. Global open,['10.1097/GOX.0000000000002691']
2302,32537715,Assessment of effects of repeated oral doses of fedratinib on inhibition of cytochrome P450 activities in patients with solid tumors using a cocktail approach.,"PURPOSE


Fedratinib, an oral selective kinase inhibitor with activity against both wild type and mutationally activated Janus kinase 2, has been approved for the treatment of adult patients with intermediate-2 or high-risk myelofibrosis by the US Food and Drug Administration. In vitro studies indicated that fedratinib was an inhibitor of several cytochrome P450 (CYP) enzymes. The primary objective of this study was to evaluate the effects of repeated doses of fedratinib on the activity of CYP2D6, CYP2C19, and CYP3A4 in patients with solid tumors using a CYP probe cocktail.
METHODS


An open-label, one-sequence, two-period, two-treatment crossover study was conducted. Patients were administered a single oral dose cocktail of metoprolol (100 mg), omeprazole (20 mg), and midazolam (2 mg) used as probe substrates for CYP2D6, CYP2C19, and CYP3A4 enzyme activities, respectively, without fedratinib on Day -1 or with fedratinib on Day 15.
RESULTS


Coadministration of 500 mg once-daily doses of fedratinib for 15 days increased the mean area under the plasma concentration-time curve from time zero to infinity following a single-dose cocktail containing metoprolol (CYP2D6 substrate), omeprazole (CYP2C19 substrate), and midazolam (CYP3A4 substrate) by 1.77-fold (90% confidence interval [CI] 1.27-2.47) for metoprolol, 2.82-fold (90% CI 2.26-3.53) for omeprazole, and 3.84-fold (90% CI 2.62-5.63) for midazolam, respectively. The mean plasma Day 14/Day 1 ratio of 4β-hydroxycholesterol, an endogenous biomarker of CYP3A4 activity, was 0.59 (90% CI 0.54-0.66), suggesting a net inhibition of CYP3A4 by fedratinib.
CONCLUSION


Fedratinib is a weak inhibitor of CYP2D6, and a moderate inhibitor of CYP2C19 and CYP3A4. These results serve as the basis for dose modifications of these CYP substrate drugs when co-administered with fedratinib.",2020,"The mean plasma Day 14/Day 1 ratio of 4β-hydroxycholesterol, an endogenous biomarker of CYP3A4 activity, was 0.59 (90% CI 0.54-0.66), suggesting a net inhibition of CYP3A4 by fedratinib.
","['patients with solid tumors using a CYP probe cocktail', 'patients with solid tumors using a cocktail approach', 'adult patients with intermediate-2 or high-risk myelofibrosis']","['omeprazole', 'metoprolol (CYP2D6 substrate), omeprazole (CYP2C19 substrate), and midazolam ', 'metoprolol', 'midazolam']","['cytochrome P450 activities', 'mean area under the plasma concentration-time curve', 'mean plasma Day 14/Day 1 ratio of 4β-hydroxycholesterol, an endogenous biomarker of CYP3A4 activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0008381', 'cui_str': 'Cholesterol monooxygenase (side-chain cleaving)'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0678420', 'cui_str': 'Cocktail'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0001815', 'cui_str': 'Myelosclerosis with myeloid metaplasia'}]","[{'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C0025859', 'cui_str': 'Metoprolol'}, {'cui': 'C0057223', 'cui_str': 'Cytochrome p450 CYP2D6 enzyme'}, {'cui': 'C0960580', 'cui_str': 'CYP2C19 protein, human'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0008381', 'cui_str': 'Cholesterol monooxygenase (side-chain cleaving)'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0020339', 'cui_str': 'Hydroxycholesterols'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1142644', 'cui_str': 'cytochrome P450 3A4 protein, human'}]",,0.0345666,"The mean plasma Day 14/Day 1 ratio of 4β-hydroxycholesterol, an endogenous biomarker of CYP3A4 activity, was 0.59 (90% CI 0.54-0.66), suggesting a net inhibition of CYP3A4 by fedratinib.
","[{'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Ogasawara', 'Affiliation': 'Bristol Myers Squibb, Summit, NJ, USA.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'LoRusso', 'Affiliation': 'Yale Cancer Center, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Olszanski', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, USA.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Rixe', 'Affiliation': 'Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Yin', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Palmisano', 'Affiliation': 'Bristol Myers Squibb, Summit, NJ, USA.'}, {'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Krishna', 'Affiliation': 'Bristol Myers Squibb, Summit, NJ, USA. gopal.krishna@bms.com.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-020-04102-3']
2303,32537717,A quasi-randomized clinical trial: virtual reality versus proprioceptive neuromuscular facilitation for postmastectomy lymphedema.,"BACKGROUND


Postmastectomy lymphedema can be considered the main cause of upper extremity functional impairment in patients with breast cancer. Fatigue, pain, and limited range of motion are common symptoms. If left untreated, lymphedema causes cellulitis, which can lead to gangrene in rare cases. This study was carried out to identify and compare the therapeutic advantages of virtual reality-based exercises and proprioceptive neuromuscular facilitation for postmastectomy lymphedema. Thus, a quasi-randomized comparative study of thirty female patients with unilateral postmastectomy lymphedema was conducted. Fifteen patients performed virtual reality-based exercises as well as manual lymphatic drainage, pneumatic compression, and home programs, while the other fifteen patients performed proprioceptive neuromuscular facilitation as well as manual lymphatic drainage, pneumatic compression, and home programs. The excess arm volume between the healthy and affected limbs was estimated before and after eight sessions of treatment for both groups. In addition, the affected limb functional score was calculated. Arm volume was calculated by the truncated cone formula and girth measurements obtained by the circumferential method. The Arabic version of the QuickDASH-9 scale was used to assess extremity function.
RESULTS


The excess arm volume significantly decreased in both the virtual reality group (p = 0.001) and proprioceptive neuromuscular facilitation group (p = 0.005), and there was no significant difference between the two groups (p = 0.902). Age was inversely related to the improvement percentage of the QuickDASH-9 score in the virtual reality group. The functional improvement percentage was statistically significantly different between the two groups (p = 0.045).
CONCLUSION


It can be concluded that both virtual reality and proprioceptive neuromuscular facilitation have a beneficial therapeutic effect on edema in patients with unilateral postmastectomy lymphedema; neither method was found to be superior, except virtual reality was found to be superior to proprioceptive neuromuscular facilitation in motivating patients and providing visual feedback.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT04185181 Registered 4 December 2019 - Retrospectively registered.",2020,"The excess arm volume significantly decreased in both the virtual reality group (p = 0.001) and proprioceptive neuromuscular facilitation group (p = 0.005), and there was no significant difference between the two groups (p = 0.902).","['patients with unilateral postmastectomy lymphedema', 'postmastectomy lymphedema', 'Registered 4 December 2019', 'Fifteen patients performed', 'patients with breast cancer', 'thirty female patients with unilateral postmastectomy lymphedema']","['virtual reality versus proprioceptive neuromuscular facilitation', 'virtual reality-based exercises and proprioceptive neuromuscular facilitation', 'virtual reality-based exercises as well as manual lymphatic drainage, pneumatic compression, and home programs, while the other fifteen patients performed proprioceptive neuromuscular facilitation as well as manual lymphatic drainage, pneumatic compression, and home programs']","['functional improvement percentage', 'limb functional score', 'QuickDASH-9 score', 'Fatigue, pain, and limited range of motion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0032775', 'cui_str': 'Post-mastectomy Lymphedema'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0556834', 'cui_str': 'Manual lymphatic drainage'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231589', 'cui_str': 'Limitation of joint movement'}]",30.0,0.0271289,"The excess arm volume significantly decreased in both the virtual reality group (p = 0.001) and proprioceptive neuromuscular facilitation group (p = 0.005), and there was no significant difference between the two groups (p = 0.902).","[{'ForeName': 'Doaa', 'Initials': 'D', 'LastName': 'Atef', 'Affiliation': 'Faculty of Physical Therapy, Cairo University, Giza, Egypt. doaa.atef@cu.edu.eg.'}, {'ForeName': 'Mohmed Maher', 'Initials': 'MM', 'LastName': 'Elkeblawy', 'Affiliation': 'National Center of Research, Giza, Egypt.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'El-Sebaie', 'Affiliation': 'Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Walid Ahmed Ibrahim', 'Initials': 'WAI', 'LastName': 'Abouelnaga', 'Affiliation': 'Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}]",Journal of the Egyptian National Cancer Institute,['10.1186/s43046-020-00041-5']
2304,32537732,"Effectiveness of matrix-rhythm therapy on increased muscle tone, balance and gait parameters in stroke survivors: a single-blinded, randomized, controlled clinical trial.","This study was conducted to investigate the effectiveness of Matrix rhythm therapy (MRT) on muscle tone, balance and gait parameters in stroke survivors. Thirty stroke individuals randomly assigned to study and control group received combining BT&MRT, and BT, respectively. This study was a single-blinded (assessor-blind), randomized controlled trial. A total of 30 stroke individuals with spastic hemiparesis (n = 30) aged between 20-65 years were included. The study group received combining BT and MRT on trunk and the affected lower limb. The control group received only BT. Participants in both groups were received therapy for 4 weeks, 3 days/week. The outcome measures were Modified Ashworth Scale (MAS), goniometric measurements (ROM), Single Leg Stance Test of the BESTest Balance Evaluation System, Timed ""Get Up & Go"" Test of the BESTest and BTS G-Walk Gait-Analysis System. Spasticity intensity, ROM, static/dynamic balance tests' scores, gait velocity, cadence, and pelvic movement symmetries improved in study group (p < 0.05).In the control group, only dynamic balance improved after the treatment program(p < 0.05). Significant improvements were found in terms of spasticity intensity, ROM of knee and ankle joints, static/dynamic balance, gait velocity and cadence in favor of the study group (p < 0.05). This study gives preliminary evidence that adding MRT to BT may be beneficial in improving balance and gait by regulating muscle tone in the affected lower limb of stroke patients with spastic hemiparesis. The study was retrospectively registered at Clinical Trials.gov (ID: NCT04213417; URL: www.clinicaltrials.gov).",2020,"Significant improvements were found in terms of spasticity intensity, ROM of knee and ankle joints, static/dynamic balance, gait velocity and cadence in favor of the study group (p < 0.05).","['Thirty stroke individuals', 'stroke survivors', 'stroke patients with spastic hemiparesis', '30 stroke individuals with spastic hemiparesis (n\u2009=\u200930) aged between 20-65\xa0years were included']","['Matrix rhythm therapy (MRT', 'matrix-rhythm therapy', 'BT', 'combining BT and MRT', 'MRT to BT']","['spasticity intensity, ROM of knee and ankle joints, static/dynamic balance, gait velocity and cadence', ""Spasticity intensity, ROM, static/dynamic balance tests' scores, gait velocity, cadence, and pelvic movement symmetries"", 'Modified Ashworth Scale (MAS), goniometric measurements (ROM), Single Leg Stance Test of the BESTest Balance Evaluation System', 'dynamic balance', 'muscle tone, balance and gait parameters']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0154694', 'cui_str': 'Spastic hemiplegia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0003087', 'cui_str': 'Ankle joint structure'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0439711', 'cui_str': 'Symmetries'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0026841', 'cui_str': 'Muscle Tension'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.135309,"Significant improvements were found in terms of spasticity intensity, ROM of knee and ankle joints, static/dynamic balance, gait velocity and cadence in favor of the study group (p < 0.05).","[{'ForeName': 'Ayse', 'Initials': 'A', 'LastName': 'Unal', 'Affiliation': 'Department of Neurological Rehabilitation, Pamukkale University School of Physical Therapy and Rehabilitation, Denizli, Turkey. aunal@pau.edu.tr.'}, {'ForeName': 'Filiz', 'Initials': 'F', 'LastName': 'Altug', 'Affiliation': 'Department of Neurological Rehabilitation, Pamukkale University School of Physical Therapy and Rehabilitation, Denizli, Turkey.'}, {'ForeName': 'Gulsum', 'Initials': 'G', 'LastName': 'Tikac', 'Affiliation': 'Department of Neurological Rehabilitation, Pamukkale University School of Physical Therapy and Rehabilitation, Denizli, Turkey.'}, {'ForeName': 'Ugur', 'Initials': 'U', 'LastName': 'Cavlak', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Avrasya University Faculty of Health Sciences, Trabzon, Turkey.'}]",Acta neurologica Belgica,['10.1007/s13760-020-01391-6']
2305,32537740,The ECG belt for CRT response trial: design and clinical protocol.,"The ECG Belt for CRT Response Trial is designed to test the hypothesis that in patients traditionally less likely to respond to cardiac resynchronization therapy (CRT), an individualized approach utilizing the ECG Belt to guide lead placement, vector selection, and device programming is superior to current standard of care. The ECG Belt is a noninvasive mapping technology designed to measure beat by beat electrical activation of the left ventricle by utilizing unipolar measurements from multiple ECG electrodes on the body surface. The ECG Belt for CRT Response Trial is a multicenter, prospective, randomized, investigational pre-market research study conducted at 48 centers in the United States, Canada, and Europe and will randomize approximately 400 subjects. The trial has three arms (enrollment will be 2:1:1 respectively): utilization of the belt to guide implant as well as post implant programming, utilizing the belt to guide post-implant programming alone, and a non-belt control arm. Adaptiv CRT will be an option in the treatment arm but not the control arms. The primary endpoint is change in left ventricular end-systolic volume between pre-implant and at 6 months. This paper describes the design and analytic plan for the trial. This article is protected by copyright. All rights reserved.",2020,The ECG Belt is a noninvasive mapping technology designed to measure beat by beat electrical activation of the left ventricle by utilizing unipolar measurements from multiple ECG electrodes on the body surface.,"['48 centers in the United States, Canada, and Europe and will randomize approximately 400 subjects']",['cardiac resynchronization therapy (CRT'],['change in left ventricular end-systolic volume'],"[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C3816746', 'cui_str': '400'}]","[{'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0455832', 'cui_str': 'Left ventricular end-systolic cavity size'}]",,0.0379119,The ECG Belt is a noninvasive mapping technology designed to measure beat by beat electrical activation of the left ventricle by utilizing unipolar measurements from multiple ECG electrodes on the body surface.,"[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rickard', 'Affiliation': 'Cleveland Clinic.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Jackson', 'Affiliation': 'Duke University Medical Center.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Biffi', 'Affiliation': 'University of Bologna.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Vernooy', 'Affiliation': 'Maastricht Universitair Medisch Centrum.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Bank', 'Affiliation': 'United Heart and Vascular Clinic.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Cerkvenik', 'Affiliation': 'Medtronic, PLC.'}, {'ForeName': 'Subham', 'Initials': 'S', 'LastName': 'Ghosh', 'Affiliation': 'Medtronic, PLC.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Gold', 'Affiliation': 'Medical University of South Carolina.'}]",Pacing and clinical electrophysiology : PACE,['10.1111/pace.13985']
2306,32535263,Effects of edaravone on postoperative cognitive function in elderly patients undergoing hip joint replacement surgery: A randomized controlled trial.,"BACKGROUND


Postoperative cognitive dysfunction (POCD) is a complication of central nervous system in patients after surgery. Edaravone as a brain-protective agent may have protective effect on postoperative cognitive function. The study was designed to explore the effects of edaravone on postoperative cognitive function in eldely patients undergoing hip joint replacement surgery and potential mechanism.
PATIENTS AND METHODS


Patients undergoing hip joint replacement surgery were randomly allocated into 2 groups: the edaravone group (group E) and the control group (group C). Group E received intravenous edaravone at a dose of 0.5mg/kg after induction of anesthesia, while group C received normal saline. The cognitive function was evaluated with the Mini-Mental State Examination (MMSE) 1day before surgery,3 days and the 7 days after surgery. Patients' plasma samples were collected to detect the levels of S100β protein (S100β), interleukin-6 (IL-6), matrix metalloproteinase-9 (MMP-9), superoxide dismutase (SOD) and malondialdehyde (MDA) before the induction of anesthesia, at the end of surgery and on postoperative day 3.
RESULTS


The MMSE scores in group E were higher than those of group C 3 days after surgery (25.98±1.99 vs 24.86±1.86, p = 0.003). There were remarkable rises (p< 0.05) in plasma IL-6, S100βand MMP-9 levels at the end of surgery and on postoperative day 3 in the two groups, however, edaravone pretreatment could reduce these levels to a certain extent compared with group C (p< 0.05).In group E, the SOD concentration was higher at the end of surgery (16.03±2.46U/ml vs. 13.65±2.53U/ml, p = 0.0001), while the MDA level was lower on postoperative day 3 than those in group C (7.01±2.37nmol/ml vs. 11.34±3.18nmol/ml, p = 0.0001).
CONCLUSION


The results indicated that preoperative intervention with edaravone may improve the postoperative cognitive function in elderly patients undergoing hip joint replacement surgery.",2020,"There were remarkable rises (p< 0.05) in plasma IL-6, S100βand MMP-9 levels at the end of surgery and on postoperative day 3 in the two groups, however, edaravone pretreatment could reduce these levels to a certain extent compared with group C (p< 0.05).In group E, the SOD concentration was higher at the end of surgery (16.03±2.46U/ml vs. 13.65±2.53U/ml, p = 0.0001), while the MDA level was lower on postoperative day 3 than those in group C (7.01±2.37nmol/ml vs. 11.34±3.18nmol/ml, p = 0.0001).
","['eldely patients undergoing hip joint replacement surgery and potential mechanism', 'Patients undergoing hip joint replacement surgery', 'patients after surgery', 'elderly patients undergoing hip joint replacement surgery']","['intravenous edaravone', 'normal saline', 'edaravone', 'Edaravone']","['MDA level', 'MMSE scores', 'cognitive function', 'SOD concentration', 'levels of S100β protein (S100β), interleukin-6 (IL-6), matrix metalloproteinase-9 (MMP-9), superoxide dismutase (SOD) and malondialdehyde (MDA', 'postoperative cognitive function', 'plasma IL-6, S100βand MMP-9 levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0070694', 'cui_str': 'edaravone'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",,0.097904,"There were remarkable rises (p< 0.05) in plasma IL-6, S100βand MMP-9 levels at the end of surgery and on postoperative day 3 in the two groups, however, edaravone pretreatment could reduce these levels to a certain extent compared with group C (p< 0.05).In group E, the SOD concentration was higher at the end of surgery (16.03±2.46U/ml vs. 13.65±2.53U/ml, p = 0.0001), while the MDA level was lower on postoperative day 3 than those in group C (7.01±2.37nmol/ml vs. 11.34±3.18nmol/ml, p = 0.0001).
","[{'ForeName': 'Nan-Nan', 'Initials': 'NN', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, 2800 Gongwei Road, Huinan Town, Pudong, Shanghai, 201399, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Chinese Medicine, 528 Zhangheng Road, Pudong, Shanghai, 201203, China. Electronic address: sun_long2@163.com.'}, {'ForeName': 'Wen-Ting', 'Initials': 'WT', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Chinese Medicine, 528 Zhangheng Road, Pudong, Shanghai, 201203, China.'}, {'ForeName': 'Yang-Liang', 'Initials': 'YL', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, 2800 Gongwei Road, Huinan Town, Pudong, Shanghai, 201399, China.'}, {'ForeName': 'Yi-Ming', 'Initials': 'YM', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, 2800 Gongwei Road, Huinan Town, Pudong, Shanghai, 201399, China. Electronic address: nange1984@sina.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.05.092']
2307,32535338,A serious-game for child sexual abuse prevention: An evaluation of orbit.,"BACKGROUND


Greater public and professional awareness of the extent and impact of child sexual abuse (CSA) has prompted the inclusions of prevention initiatives within school curricula. However CSA education is not always soundly grounded in empirical evidence, and evaluations of the impact of programs often inadequate.
OBJECTIVE


This paper reports on a randomized-control trial of an empirically informed serious-game for CSA prevention, for children aged 8-10 years. The study also evaluates the impact on learning of complementary classroom lessons and part completion of the Orbit game.
PARTICIPANTS AND SETTING


The evaluation involved 139 students (female = 78; male = 61) aged 8-10 years (Mage = 9.64, SD = 0.33), from an elementary school in Queensland, Australia.
METHOD


All children were pre-tested and post-tested (at 3 months) for knowledge of abuse prevention using the Children's Knowledge of Abuse Questionnaire-Revised (CKAQ-R-III), and a short form (SF) mapped to the learning objectives of Orbit . Children were assigned to one of three groups; i) play Orbit (n = 50); ii) play Orbit and CSA lessons (n = 55); and iii) control (n = 34).
RESULTS


Children in the Orbit play, and Orbit play and lesson groups, significantly (p < .001) increased their CKAQ SF scores, whereas those in the control group did not. Furthermore, those children who completed all of Orbit significantly (p < .001) increased their post-test CKAQ scores, whereas those who didn't complete the game did not.
CONCLUSIONS


This study shows the strength of a serious-games approach for school CSA prevention whilst reporting how child completion can impact learnings.",2020,"RESULTS


Children in the Orbit play, and Orbit play and lesson groups, significantly (p < .001) increased their CKAQ SF scores, whereas those in the control group did not.","['child sexual abuse (CSA', 'child sexual abuse prevention', ""All children were pre-tested and post-tested (at 3 months) for knowledge of abuse prevention using the Children's Knowledge of Abuse Questionnaire-Revised (CKAQ-R-III), and a short form (SF) mapped to the learning objectives of Orbit "", 'The evaluation involved 139 students (female\u202f=\u202f78; male\u202f=\u202f61) aged 8-10 years (Mage\u202f=\u202f9.64, SD\u202f=\u202f0.33), from an elementary school in Queensland, Australia', 'children aged 8-10 years']",['play Orbit (n\u202f=\u202f50); ii) play Orbit and CSA lessons (n\u202f=\u202f55); and iii) control'],"['post-test CKAQ scores', 'CKAQ SF scores']","[{'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1261558', 'cui_str': 'Abuse prevention'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0029180', 'cui_str': 'Orbital cavity'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517449', 'cui_str': '0.33'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0034391', 'cui_str': 'Queensland'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0029180', 'cui_str': 'Orbital cavity'}, {'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",139.0,0.0282223,"RESULTS


Children in the Orbit play, and Orbit play and lesson groups, significantly (p < .001) increased their CKAQ SF scores, whereas those in the control group did not.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'School of Social Sciences, University of the Sunshine Coast, Queensland, Australia. Electronic address: cmjones@usc.edu.au.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Scholes', 'Affiliation': 'Institute for Learning Sciences & Teacher Education, Australian Catholic University, Queensland, Australia. Electronic address: laura.scholes@acu.edu.au.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Rolfe', 'Affiliation': 'Ecoludology Games, Queensland, Australia. Electronic address: ben@ecoludology.com.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Stieler-Hunt', 'Affiliation': 'School of Creative Industries, University of the Sunshine Coast, Queensland, Australia. Electronic address: cstieler@usc.edu.au.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104569']
2308,32535341,Effects and safety of body positioning on back pain after transcatheter arterial chemoembolization in people with hepatocellular carcinoma: A randomized controlled study.,"BACKGROUND


People with hepatocellular carcinoma who undergo transcatheter arterial chemoembolization usually experience back pain due to lie supine for at least 4 hours to avoid bleeding and hematoma. Body positioning is an effective and safe method for decreasing back pain in people with transfemoral cardiac catheterization; however, its effects and safety among patients with high bleeding tendency are unknown.
OBJECTIVE


To investigate whether body positioning could decrease back pain without increasing the chance of bleeding after transcatheter arterial chemoembolization.
DESIGN


A single-blind randomized controlled trial (ClinicalTrials.gov No.: NCT03784469).
METHODS


A total of 78 people with liver cancer who had undergone chemoembolization through the femoral artery were enrolled. Each person was randomly assigned to either the control or intervention group (each consisted of 39 participants). The control group received the usual care, remaining flat and lying in a supine position, whereas the intervention group had their positions changed in the second and fourth hour after chemoembolization. Participants' pain level was rated by using numerical rating scale -11 (score from 0 to 10), bleeding was measured by using volume of blood (cc.) in gauze and hematoma size in diameter (cm), and satisfaction was self-rated from 1 to 5. Repeated-measure analysis of variance (ANOVA) was used to compare the difference in pain levels over time within each group and independent t test to compare the mean difference of pain between groups at 5 endpoints, both methods with Bonferroni adjustment. Independent t test, chi-squared test, and Fisher's exact test compared postembolization discomfort, puncture sites bleeding, satisfaction between groups.
RESULTS


Significant changes of pain levels over time in both intervention [F(2.93, 111.20)=7.64, p<.001] and control groups [F(2.66, 101.17)=20.55, p<.001]. The intervention group had a significantly lower mean pain score in the second hour (t = -2.838, p = .006) and fourth hour (t = -4.739, p < .001) when patients turning to the side than did the control group lying supine. Furthermore, patients in the intervention group had significantly higher satisfaction than did those in the control group (t = -2.422, p = .018). No hematoma and significant difference of post-procedural bleeding between groups.
CONCLUSION


Changing patients' body positions in bed after transcatheter arterial chemoembolization is a safe and effective method of decreasing back pain, and increasing patients' satisfaction, without increasing the complications of bleeding and hematoma. Clinicians should change the positions of people with hepatocellular carcinoma 2 hours after they receive transcatheter arterial chemoembolization.",2020,"-4.739, p < .001) when patients turning to the side than did the control group lying supine.","['people with hepatocellular carcinoma', '78 people with liver cancer who had undergone chemoembolization through the femoral artery were enrolled', 'People with hepatocellular carcinoma who undergo transcatheter arterial chemoembolization usually experience back pain', 'people with transfemoral cardiac catheterization']","['body positioning', 'transcatheter arterial chemoembolization']","['pain level', 'pain levels', 'back pain', 'numerical rating scale -11', 'bleeding', 'mean pain score', 'higher satisfaction']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0345904', 'cui_str': 'Malignant neoplasm of liver'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C2711393', 'cui_str': 'Transarterial chemoembolization of hepatic artery'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0018795', 'cui_str': 'Cardiac catheterization'}]","[{'cui': 'C1262869', 'cui_str': 'Body position'}, {'cui': 'C2711393', 'cui_str': 'Transarterial chemoembolization of hepatic artery'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",78.0,0.143191,"-4.739, p < .001) when patients turning to the side than did the control group lying supine.","[{'ForeName': 'Kai-Ting', 'Initials': 'KT', 'LastName': 'Chang', 'Affiliation': 'Department of Nursing, National Taiwan University Hospital, No.7, Chung Shan S. Rd., Taipei City, 10002, Taiwan. Electronic address: kaiting105866@gmail.com.'}, {'ForeName': 'Chun-Jen', 'Initials': 'CJ', 'LastName': 'Liu', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, National, Taiwan University Hospital, No.7, Chung Shan S. Rd., Taipei City, 10002, Taiwan. Electronic address: cjliu@ntu.edu.tw.'}, {'ForeName': 'Hsiu-Ting', 'Initials': 'HT', 'LastName': 'Tsai', 'Affiliation': 'Post-Baccalaureate Program in Nursing, Taipei Medical University, No. 250 Wu-Xing Street, Taipei City, 110, Taiwan. Electronic address: hsiuting@tmu.edu.tw.'}, {'ForeName': 'Tse-Pin', 'Initials': 'TP', 'LastName': 'Hsu', 'Affiliation': 'Department of Nursing, National Taiwan University Hospital, Chung Shan S. Rd., Taipei City, 10002, Taiwan. Electronic address: 021077@ntuh.gov.tw.'}, {'ForeName': 'Po-Ting', 'Initials': 'PT', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Imaging, National Taiwan University Hospital, Chung Shan S. Rd., Taipei City, 10002, Taiwan. Electronic address: nate770407@gmail.com.'}, {'ForeName': 'Sophia H', 'Initials': 'SH', 'LastName': 'Hu', 'Affiliation': 'School of Nursing, College of Nursing, National Yang-Ming University, No.155, Sec.2, Li-Nong Street, Taipei City, 112, Taiwan. Electronic address: sophiahu@ym.edu.tw.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103641']
2309,32535342,Food intake is associated with verbal interactions between nursing home staff and residents with dementia: A secondary analysis of videotaped observations.,"BACKGROUND


Nursing home residents with dementia commonly experience low food intake, leading to negative functional and nutritional consequences. While the importance of staff-resident (dyadic) interactions during mealtime is acknowledged, little research has examined the role of dyadic verbal interactions on food intake.
OBJECTIVES


This study aimed to examine the relationship between food intake and dyadic verbal interactions.
METHODS


This study was a secondary analysis of 110 videotaped observations of mealtime care interactions among 25 residents with dementia and 29 staff (42 unique dyads) in 9 nursing homes. Staff positive utterances and resident positive and negative utterances (independent variables) and food intake (dependent variable) were coded from the videotaped observations using the Cue Utilization and Engagement in Dementia video coding scheme. A linear mixed model was fit to the data. The two-way interaction effects of food type and video duration with each independent variable as well as two-way interaction effects among the independent variables were tested. Covariates included in the model were the number of years staff worked as a caregiver, and resident age, gender, and eating function.
RESULTS


The model included three significant interaction effects involving verbal variables: the interaction effect of staff positive utterances with resident positive utterances (p=.030), the interaction effect of staff positive utterances with food type (p=.027), and the interaction effect of resident negative utterances with video duration (p=0.002). Increased number of intakes of liquid food per minute was associated with increased number of staff positive utterances per minute when residents did not make positive utterances. Decreased number of intakes of solid food per minute was associated with increased number of staff positive utterances per minute, especially when residents made between 0 and 3 positive utterances per minute. As the duration of the videos increased, the number of intakes per minute increased for residents who made one or more negative utterances and decreased for residents who made no negative utterances in the videos. The number of intakes per minute was associated with resident gender in that male residents had increased number of intakes per minute compared with female residents (p=.017), and was not associated with other participant characteristics.
CONCLUSION


Intake was associated with dyadic verbal interactions, and such relationship was complex in that it was moderated by food type and video duration. Findings support the significant role of dyadic verbal interactions on intake, and inform the development of effective, tailored mealtime care interventions to promote intake.",2020,"The number of intakes per minute was associated with resident gender in that male residents had increased number of intakes per minute compared with female residents (p=.017), and was not associated with other participant characteristics.
","['25 residents with dementia and 29 staff (42 unique dyads) in 9 nursing homes', 'nursing home staff and residents with dementia']",[],"['number of intakes per minute', 'dyadic verbal interactions', 'Staff positive utterances and resident positive and negative utterances (independent variables) and food intake', 'number of staff positive utterances']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0013470', 'cui_str': 'Eating'}]",110.0,0.0676015,"The number of intakes per minute was associated with resident gender in that male residents had increased number of intakes per minute compared with female residents (p=.017), and was not associated with other participant characteristics.
","[{'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'The University of Iowa, College of Nursing, Iowa City, IA, USA. Electronic address: wen-liu-1@uiowa.edu.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Perkhounkova', 'Affiliation': 'The University of Iowa, College of Nursing, Iowa City, IA, USA.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Williams', 'Affiliation': 'The University of Kansas, School of Nursing, Kansas City, KS, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Batchelor', 'Affiliation': 'George Washington University, School of Nursing, Washington, D.C., USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hein', 'Affiliation': 'The University of Iowa, College of Nursing, Iowa City, IA, USA.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103654']
2310,32535407,An investigation of the impact of social exclusion on attachment to possessions and saving behaviors.,"BACKGROUND AND OBJECTIVES


Hoarding disorder (HD) is a debilitating mental illness characterized by extreme difficulty parting with possessions and clutter that can result in dangerous living conditions. One hypothesis about why individuals with HD save possessions is that they possess a pathological attachment to their belongings, which may serve to compensate for unfulfilling interpersonal relationships. However, there is a dearth of empirical work examining this. The current study examined the impact of an experimental manipulation of social exclusion on attachment to possessions and saving behaviors in a sample of individuals with elevated hoarding symptoms.
METHODS


Participants (n = 117) were selected for scoring above the non-clinical mean on a measure of hoarding symptoms. Participants were randomized to either be included or excluded in a game of Cyberball. They completed a behavioral discarding task and object attachment measure before and after completion of the game.
RESULTS


Study condition was unrelated to in vivo attachment to possessions and saving behaviors during the discarding task. However, a post hoc mediation model showed that greater feelings of rejection, regardless of condition, were associated with greater in vivo attachment to possessions and subsequent number of items saved during the lab task.
LIMITATIONS


Limitations include the use of a non-clinical and homogeneous sample.
CONCLUSIONS


Taken together, individuals prone to feelings of rejection may be at risk for developing HD as they may use possessions to cope with interpersonal stress. Results will be discussed in light of implications for theoretical models and potential treatment targets in HD.",2020,"However, a post hoc mediation model showed that greater feelings of rejection, regardless of condition, were associated with greater in vivo attachment to possessions and subsequent number of items saved during the lab task.
","['individuals with elevated hoarding symptoms', 'Participants (n\xa0=\xa0117']",[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",[],[],117.0,0.034374,"However, a post hoc mediation model showed that greater feelings of rejection, regardless of condition, were associated with greater in vivo attachment to possessions and subsequent number of items saved during the lab task.
","[{'ForeName': 'Brittany M', 'Initials': 'BM', 'LastName': 'Mathes', 'Affiliation': 'Florida State University, United States.'}, {'ForeName': 'Norman B', 'Initials': 'NB', 'LastName': 'Schmidt', 'Affiliation': 'Florida State University, United States. Electronic address: schmidt@psy.fsu.edu.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101588']
2311,32535481,Efficacy and safety of Abelmoschus manihot for IgA nephropathy: A multicenter randomized clinical trial.,"RATIONALE AND OBJECTIVE


IgA nephropathy (IgAN) is an important cause for end-stage renal disease worldwide. The treatment for IgAN remains challenging, and few randomized and controlled clinical trials have been conducted to evaluate new therapies. The present study assesses the efficacy and safety of Abelmoschus manihot (AM) in IgAN patients.
STUDY DESIGN


Randomized, non-inferiority, double-blind, double-dummy multicenter trial.
SETTING AND PARTICIPANTS


This trial was designed to recruit 1,600 biopsy-proven IgAN patients (proteinuria between 0.5-3.0 g/d and estimated glomerular filtration rate [eGFR] of ≥ 45 ml/min/1.73 m 2 ) across China.
INTERVENTIONS


The participants were randomized at 1:1 to AM (2.5 g for three times per day) or losartan potassium (100 mg per day) for 48 weeks.
OUTCOMES


The primary outcome was the change in 24-hour proteinuria from baseline to week 48. The secondary outcomes were the change in eGFR from baseline to week 48, and the incidents of endpoint events (proteinuria ≥ 3.5 g/24 h, doubling of serum creatinine, or receiving renal replacement treatment).
RESULTS


Among 1,470 randomized patients (mean age, 37.4 [SD, 10.6] years old; 777 [52.9%] were female; mean eGFR, 95.0 [SD, 24.3] mL/min/1.73 m 2 ; mean 24-hour proteinuria, 1.2 [SD, 0.7] g/d), the mean decline in 24-h proteinuria at week 48 was 230 mg and 253 mg in the AM and losartan potassium groups, respectively (P = 0.676). The mean difference in the change in 24-h proteinuria between these two groups was -23.32 mg (95% confident interval: -123.2 to 76.6, p = 0.647). The mean decline in eGFR was 0.41 ml/min/1.73 m 2  and 0.76 ml/min/1.73 m 2  in the AM and losartan potassium groups, respectively (p = 0.661). The mean difference in the change in eGFR between these two groups was -0.43 ml/min/1.73 m 2  (95% confident interval: -1.99 to 1.13, p = 0.589). The incidence of endpoint events was 8.6% in the AM group and 8.2% in the losartan group (p = 0.851).
LIMITATIONS


The results of the trial may not be generalized to IgAN patients with a proteinuria of > 3.0 g/d and an eGFR of < 45 ml/min/1.73 m 2 . The long-term benefits of AM in reducing the risk of progressive renal dysfunction remains unclear, based on this 48-week observation.
CONCLUSION


AM can be recommended as a promising treatment for IgAN patients.",2020,The mean difference in the change in eGFR between these two groups was -0.43,"['IgAN patients', '1,470 randomized patients (mean age, 37.4 [SD, 10.6] years old; 777 [52.9%] were female; mean eGFR, 95.0 [SD, 24.3] mL/min/1.73 m 2 ; mean 24-hour proteinuria, 1.2 [SD, 0.7] g/d), the mean decline in 24-h proteinuria at week 48 was 230 mg and 253 mg in the AM and losartan potassium groups, respectively (P\xa0=\xa00.676', 'IgA nephropathy', '1,600 biopsy-proven IgAN patients (proteinuria between 0.5-3.0 g/d and estimated glomerular filtration rate [eGFR] of ≥ 45 ml/min/1.73 m 2 ) across China']","['AM', 'Abelmoschus manihot (AM', 'losartan potassium', 'Abelmoschus manihot', 'losartan']","['change in 24-hour proteinuria', 'eGFR', '24-h proteinuria', 'Efficacy and safety', 'mean decline in eGFR', 'incidence of endpoint events', 'efficacy and safety', 'change in eGFR']","[{'cui': 'C0017661', 'cui_str': 'IgA nephropathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517741', 'cui_str': '37.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0949866', 'cui_str': 'Abelmoschus'}, {'cui': 'C0996896', 'cui_str': 'Manihot'}, {'cui': 'C0700492', 'cui_str': 'Losartan potassium'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0949866', 'cui_str': 'Abelmoschus'}, {'cui': 'C0996896', 'cui_str': 'Manihot'}, {'cui': 'C0700492', 'cui_str': 'Losartan potassium'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",1470.0,0.162545,The mean difference in the change in eGFR between these two groups was -0.43,"[{'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Nephrology, Chinese PLA Institute of Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Chinese PLA General Hospital, Chinese PLA Medical School, Beijing 100853, China.'}, {'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning 116011, China.'}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Ni', 'Affiliation': 'Department of Nephrology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200127, China.'}, {'ForeName': 'Yongli', 'Initials': 'Y', 'LastName': 'Zhan', 'Affiliation': ""Department of Nephrology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Yani', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Nephrology, Da Ping Hospital of Third Military Medical University, Chongqing, 400042, China.'}, {'ForeName': 'Hongtao', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Nephrology, First Teaching Hospital of Tianjin University of TCM, Tianjin 300192, China.'}, {'ForeName': 'Jingai', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Department of Nephrology, The First Hospital of Shanxi Medical University, Taiyuan 030024, China.'}, {'ForeName': 'Niansong', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, The Six Affiliated Hospital of Shanghai Jiao Tong University School of Medicine, Shanghai 200233, China.'}, {'ForeName': 'Wenge', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Nephrology, China-Japan Friendship Hospital, Beijing 100029, China.'}, {'ForeName': 'Guangyan', 'Initials': 'G', 'LastName': 'Cai', 'Affiliation': 'Department of Nephrology, Chinese PLA Institute of Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Chinese PLA General Hospital, Chinese PLA Medical School, Beijing 100853, China.'}, {'ForeName': 'Yizhi', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Nephrology, Chinese PLA Institute of Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Chinese PLA General Hospital, Chinese PLA Medical School, Beijing 100853, China.'}, {'ForeName': 'Peiqing', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Nephrology, Heilongjiang Provincial Academy of Traditional Chinese Medicine, Heilongjiang, 150036, China.'}, {'ForeName': 'Xiaoqin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, 430061, China.'}, {'ForeName': 'Qinkai', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital of Nanchang University, Nanchang, 330006, China.'}, {'ForeName': 'Zhenjiang', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Nephrology, Shanxi Provincial People's Hospital, Xi'an, 710068, China.""}, {'ForeName': 'Xuefeng', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Nephrology, Chinese PLA Institute of Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Chinese PLA General Hospital, Chinese PLA Medical School, Beijing 100853, China. Electronic address: xfssun@126.com.'}, {'ForeName': 'Xiangmei', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Nephrology, Chinese PLA Institute of Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Chinese PLA General Hospital, Chinese PLA Medical School, Beijing 100853, China. Electronic address: xmchen301@126.com.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2020.153231']
2312,32535558,SURGICAL STABILIZATION OF MULTIPLE RIB FRACTURES AND MULTIPLE LONG BONE FRACTURES OF LOWER EXTREMITIES IN POLYTRAUMA PATIENTS.,"Objectives - determine the impact of rib osteosynthesis on the incidence of complications development and mortality in patients with multiple rib fractures and multiple long bone fractures of lower extremities. A prospective controlled trial was conducted from June 2015 to December 2019, and included adult patients with polytrauma, Injury Severity Score (ISS) ≥18p, multiple long bone fractures of lower extremities, one of which is the femur, and multiple rib fractures. All included patients were divided into two groups: in Group I - 17 patients who underwent surgical stabilization of rib fractures, Group II - 24 included patients treated without rib osteosynthesis. There were no significant statistic differences between patients of Group I and Group II in demographics, mechanism of injury, severity of trauma, and overall patient status. All patients had high rates of injury severity for ISS (37.8±7.9 vs. 36.9±8.6, p=0.863), New Injury Severity Score (NISS) (39.5±9.2 vs. 38.5±7.6, p=0.759) and Glasgow Coma Scale (GCS) (8.2±3.5 vs. 8.7±3.8, p=0.896).The time between trauma and rib osteosynthesis in Group I was 3.4±1.7 days. The period from trauma to definitive long bone osteosynthesis was 6.9±3.2 days in Group I and 9.4±3.8 days in Group II (p=0.039). Patients of Group I compared with Group II had a lower incidence of Acute Respiratory Distress Syndrome (ARDS) (23.5% vs. 54.2%, p=0.049) and pneumonia (29.4% vs. 62,5%, p= 0.038), shorter terms of Mechanical Ventilation (MV) (11.6±9.4 vs. 18.9±9.9, p=0.001), Length Of Stay in Intensive Care Unit (LOS ICU) (15.3±10.2 vs. 22.1±10.8, p=0.003) and Hospital Length Of Stay (HLOS) (36.9±15.8 vs. 44.3±17.4, p=0.001). Use of the rib osteosynthesis in patients with severe polytrauma, multiple rib and long bone of lower extremity fractures is more effective tactic comparing to non-surgical rib fracture treatment, it allows to reduce the incidence of ARDS and pneumonia, decreases the duration of MV, LOS ICU and HLOS.",2020,"There were no significant statistic differences between patients of Group I and Group II in demographics, mechanism of injury, severity of trauma, and overall patient status.","['patients with severe polytrauma, multiple rib and long bone of lower extremity fractures', 'June 2015 to December 2019, and included adult patients with polytrauma, Injury Severity Score (ISS) ≥18p, multiple long bone fractures of lower extremities, one of which is the femur, and multiple rib fractures', 'patients with multiple rib fractures and multiple long bone fractures of lower extremities']","['surgical stabilization of rib fractures, Group II - 24 included patients treated without rib osteosynthesis', 'rib osteosynthesis']","['Acute Respiratory Distress Syndrome (ARDS', 'Glasgow Coma Scale (GCS', 'Mechanical Ventilation (MV', 'New Injury Severity Score (NISS', 'Hospital Length', 'Length Of Stay in Intensive Care Unit (LOS ICU', 'injury severity for ISS', 'pneumonia', 'Of Stay (HLOS', 'duration of MV, LOS ICU and HLOS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026771', 'cui_str': 'Multiple injuries'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0035561', 'cui_str': 'Bone structure of rib'}, {'cui': 'C0222647', 'cui_str': 'Structure of long bone'}, {'cui': 'C1542178', 'cui_str': 'Fracture of lower leg'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021504', 'cui_str': 'Injury severity score'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0272567', 'cui_str': 'Fracture of multiple ribs'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0035522', 'cui_str': 'Fracture of rib'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0035561', 'cui_str': 'Bone structure of rib'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}]","[{'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0021504', 'cui_str': 'Injury severity score'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1740819', 'cui_str': 'Idiopathic short stature'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",,0.0175008,"There were no significant statistic differences between patients of Group I and Group II in demographics, mechanism of injury, severity of trauma, and overall patient status.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dubrov', 'Affiliation': '1Bogomolets National Medical University, Kyiv; 3Kyiv City Clinical Hospital №17, Ukraine.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Burianov', 'Affiliation': '1Bogomolets National Medical University, Kyiv, Ukraine.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Lianskorunskyi', 'Affiliation': '1Bogomolets National Medical University, Kyiv; 3Kyiv City Clinical Hospital №17, Ukraine.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Miasnikov', 'Affiliation': '1Bogomolets National Medical University, Kyiv; 3Kyiv City Clinical Hospital №17, Ukraine.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Tkalich', 'Affiliation': '2Shupyk National Medical Academy of Postgraduate Education, Kyiv; 3Kyiv City Clinical Hospital №17, Ukraine.'}]",Georgian medical news,[]
2313,32535564,COMPARISON OF POSTERIOR CAPSULE OPACIFICATION AFTER IMPLANTATION OF SAME DESIGN SINGLE-PIECE HYDROPHILIC AND HYDROPHOBIC ACRYLIC INTRAOCULAR LENSES.,"The aim of the study was to determine the correlation between implanted IOL material type and posterior capsule opacification. At 12 month, there was no statistically and visually significant changes in all controlled groups. At 18 month, 3 eyes (5.2%) from Group 2 and 1 eye (5.8%) from hydrophobic arm of Group 3 had visually significant PCO and underwent Nd:YAG laser posterior capsulotomy. 8 eyes (10.8%) in group 1 and 3 eyes (17.6%) in hydrophilic arm of Group 3 required Nd:YAG laser posterior capsulotomy. At 3, 6, and 12 month compared to baseline (1 month postoperatively), there was no statistically and clinically significant difference in visual acuity and subjective refraction between the groups. At 12 month, 3 patients (4%) from group 1 and 1 patient (6%) from hydrophilic arm of group 3 complained of glare sensitivity, especially in mesopic conditions. At that point, interestingly, no patient from Group 2 and hydrophobic arm of Group 3 complained about glare sensitivity. In terms of UCDVA, 68 eyes of group 1 (91%) achieved 20/20 or better distance vision, 71 eyes (96%) achieved 20/25 distance vision. In Group 2, 50 eyes (87%) achieved 20/20 or better distance vision, 52 eyes (92%) achieved 20/25 distance vision. In Group 3, 14 eyes (82%) of hydrophilic arm achieved 20/20 or better distance vision and 15 eyes (88%) achieved 20/25 distance vision. In hydrophobic arm of group 3, 16 eyes (94%) achieved 20/20 or better distance vision. UCDVA was examined with ClearChart 2 Digital Acuity System (Reichert Technologies), using Landolt C optotypes. Biometry data was acquired by IOLMaster-500 (Carl Zeiss, Meditec). Contrast sensitivity was evaluated with ClearChart 2 Digital Acuity System (Reichert Technologies), using Pelli-Robson Contrast Sensitivity Chart. At 1, 3, 6, month there was no statistically significant difference between controlled groups in terms of contrast sensitivity. At 12 month, 5 patients (6%) from Group 1 and 3 patients (17%) from Group 3 hydrophilic arm had slightly decreased contrast sensitivity. There was no changes in contrast sensitivity in eyes of Group 2 at 12 month period. The study is still ongoing. The patients will be evaluated at 24 month and 36 month postoperatively.",2020,"At 1, 3, 6, month there was no statistically significant difference between controlled groups in terms of contrast sensitivity.",[],['UCDVA'],"['20/25 distance vision', 'visual acuity and subjective refraction', 'Contrast sensitivity', 'contrast sensitivity', 'distance vision', 'glare sensitivity']",[],[],"[{'cui': 'C1690939', 'cui_str': '20/25'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1301318', 'cui_str': 'Subjective refraction'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0278215', 'cui_str': 'Glare'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.0489247,"At 1, 3, 6, month there was no statistically significant difference between controlled groups in terms of contrast sensitivity.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dvali', 'Affiliation': 'Tbilisi State Medical University, Department of Eye Disease; Eye clinic ""Akhali Mzera"", Tbilisi, Georgia.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Tsertsvadze', 'Affiliation': 'Tbilisi State Medical University, Department of Eye Disease; Eye clinic ""Akhali Mzera"", Tbilisi, Georgia.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Mekvabishvili', 'Affiliation': 'Tbilisi State Medical University, Department of Eye Disease; Eye clinic ""Akhali Mzera"", Tbilisi, Georgia.'}]",Georgian medical news,[]
2314,32535591,Identifying Predictors of the Visceral Fat Index in the Obese and Overweight Population to Manage Obesity: A Randomized Intervention Study.,"INTRODUCTION


Nowadays, obesity is one of the main causes of death and disability. In recent years, it has been shown that the excess and distribution of body fat increases morbidity, with excess visceral fat being the most important factor that triggers pathologies. Thus, estimation of visceral fat makes it possible to identify patients with a higher cardiovascular risk, aiding the management of obesity. The main objective of the study was to identify predictors of the visceral fat index through a lifestyle intervention and to observe the effect of the intervention on dietary habits and functional capacity.
METHODS


A randomized intervention, parallel-group study was made. This study included 97 obese and overweight people (control group, n = 48; experimental group, n = 49) with a low socioeconomic status in an 8-month lifestyle intervention. Anthropometric, fitness and nutritional tests were assessed.
RESULTS


It was found that being female, eating the recommended daily portions of fruit, gaining strength in the legs and gaining flexibility are factors predictive of a lower visceral fat index. Age over 45 years and eating the recommended weekly portions of cereals and meats, fat and processed meats increases the visceral fat index after a lifestyle intervention. There were changes in the visceral fat index and in the different physical condition variables, but not in eating habits.
CONCLUSION


A multicomponent lifestyle intervention reduces the visceral fat index; age over 45 and consuming cereals and meat increases the visceral fat index.",2020,A multicomponent lifestyle intervention reduces the visceral fat index; age over 45 and consuming cereals and meat increases the visceral fat index.,"['97 obese and overweight people (control group, n = 48; experimental group, n = 49) with a low socioeconomic status in an 8-month lifestyle intervention', 'Obese and Overweight Population to Manage Obesity']",['multicomponent lifestyle intervention'],"['Anthropometric, fitness and nutritional tests', 'dietary habits and functional capacity', 'visceral fat index', 'Visceral Fat Index']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",97.0,0.0156355,A multicomponent lifestyle intervention reduces the visceral fat index; age over 45 and consuming cereals and meat increases the visceral fat index.,"[{'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'López-Hernández', 'Affiliation': 'Department of Nursing, Universidad Católica de Valencia San Vicente Mártir, Valencia, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Pérez-Ros', 'Affiliation': 'Department of Nursing, Universidad Católica de Valencia San Vicente Mártir, Valencia, Spain, pilar.perez@ucv.es.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Fargueta', 'Affiliation': 'Faculty of Physical Activity and Sport Sciences, Universidad Católica de Valencia San Vicente Martir, Valencia, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Elvira', 'Affiliation': 'Faculty of Physical Activity and Sport Sciences, Universidad Católica de Valencia San Vicente Martir, Valencia, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'López-Soler', 'Affiliation': 'Faculty of Physical Activity and Sport Sciences, Universidad Católica de Valencia San Vicente Martir, Valencia, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Pablos', 'Affiliation': 'Faculty of Physical Activity and Sport Sciences, Universidad Católica de Valencia San Vicente Martir, Valencia, Spain.'}]",Obesity facts,['10.1159/000507960']
2315,32535600,Comparison of Therapeutic Results with/without Additional Hyperbaric Oxygen Therapy in Idiopathic Sudden Sensorineural Hearing Loss: A Randomized Prospective Study.,"OBJECTIVE


To assess the efficacy of the combination of hyperbaric oxygen (HBO) and pharmacological treatment in patients with idiopathic sudden sensorineural hearing loss (ISSNHL) and define patients amenable for HBO therapy.
METHODS


Prospective, randomized, trial involving 136 cases with unilateral ISSNHL that were randomly divided into 2 groups: the pharmacological treatment (P) group and HBO + pharmacological treatment (HBO+P) group, which received additional HBO for 14 days besides the pharmacological treatments. Pure tone audiometry gain larger than 15 dBHL was defined as success, and the success rate of each group was calculated.
RESULTS


The overall success rate of the HBO+P group and the P group is 60.6% (40/66) and 42.9% (30/70), respectively (p < 0.05). Furthermore, patients with mild-moderate baseline hearing loss, aged ≤50 years, receiving treatment in ≤14 days, or without accompanied dizziness/vertigo in the HBO+P group had higher success rate than the P group (p < 0.05).
CONCLUSIONS


HBO combined with pharmacological treatments leads to better hearing recovery than pharmacological treatments alone.",2020,"The overall success rate of the HBO+P group and the P group is 60.6% (40/66) and 42.9% (30/70), respectively (p < 0.05).","['Idiopathic Sudden Sensorineural Hearing Loss', '136 cases with unilateral ISSNHL', 'patients with idiopathic sudden sensorineural hearing loss (ISSNHL) and define patients amenable for HBO therapy']","['pharmacological treatment (P) group and HBO + pharmacological treatment (HBO+P) group, which received additional HBO', 'Hyperbaric Oxygen Therapy', 'HBO+P', 'hyperbaric oxygen (HBO) and pharmacological treatment']","['hearing recovery', 'dizziness/vertigo', 'success rate', 'overall success rate']","[{'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C4275242', 'cui_str': 'Sudden sensorineural hearing loss'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}]","[{'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",136.0,0.0179251,"The overall success rate of the HBO+P group and the P group is 60.6% (40/66) and 42.9% (30/70), respectively (p < 0.05).","[{'ForeName': 'Busheng', 'Initials': 'B', 'LastName': 'Tong', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Niu', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, The First Affiliated Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Ku', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Xie', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, The Second Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Dai', 'Affiliation': 'Department of Otolaryngology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Hellström', 'Affiliation': 'Department of Otolaryngology Head and Neck, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Maoli', 'Initials': 'M', 'LastName': 'Duan', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, The First Affiliated Hospital of Anhui Medical University, Hefei, China, maoli.duan@ki.se.'}]",Audiology & neuro-otology,['10.1159/000507911']
2316,32535601,Effects of Combined Physical Movement Activity and Multifaceted Cognitive Training in Older People with Mild Neurocognitive Disorder in a Rural Community: A Randomized Control Trial.,"INTRODUCTION


Cognitive deterioration in older people with mild neurocognitive disorders (mNCD) increases the risk of progress to major NCD. Health professionals worldwide are trying to find strategies for prevention. There is a limited number of studies that deal with cultural conditions in northern Thailand.
OBJECTIVES


This study aimed to investigate the effects of a combination of physical movement activity and multifaceted cognitive training on cognitive function in older people with mNCD.
METHODS


A randomized control trial involving 70 mNCD people, according to DSM-5 criteria, was conducted on an intervention group and a control group (n = 35 each). The program for the intervention group included 24 sessions (twice a week). The outcome measures on cognitive function were assessed before and after the intervention by means of composite cognitive measures for older people, i.e., the Trail-Making Test (TMT), Digit Span (DS), Verbal Fluency (VF), Word-List Learning (WLL), and Block Design (BD).
RESULTS


The combined intervention enhanced cognitive function. TMT-A was significantly improved in the intervention group. There were significant improvements in DS sequence scores, letter verbal fluency (LVF), and category verbal fluency (CVF). Comparing the groups, there were significant differences in LVF including immediate and delayed recall. BD improved significantly in the intervention group.
CONCLUSIONS


The combined intervention appeared to be effective in delaying/preventing cognitive deterioration and cognitive functional decline in people with mNCD. Further studies on a variation of treatments suited to cultural conditions and their effects are needed. Trials in other communities are also recommended.",2020,The combined intervention appeared to be effective in delaying/preventing cognitive deterioration and cognitive functional decline in people with mNCD.,"['Older People with Mild Neurocognitive Disorder in a Rural Community', 'people with mNCD', '70 mNCD people, according to DSM-5 criteria, was conducted on an intervention group and a control group (n = 35 each', 'older people with mNCD', 'older people with mild neurocognitive disorders (mNCD']","['physical movement activity and multifaceted cognitive training', 'Combined Physical Movement Activity and Multifaceted Cognitive Training']","['BD', 'composite cognitive measures for older people, i.e., the Trail-Making Test (TMT), Digit Span (DS), Verbal Fluency (VF), Word-List Learning (WLL), and Block Design (BD', 'cognitive deterioration and cognitive functional decline', 'DS sequence scores, letter verbal fluency (LVF), and category verbal fluency (CVF', 'cognitive function', 'LVF including immediate and delayed recall', 'TMT-A']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0854193', 'cui_str': 'Cognitive deterioration'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]",70.0,0.0368529,The combined intervention appeared to be effective in delaying/preventing cognitive deterioration and cognitive functional decline in people with mNCD.,"[{'ForeName': 'Jiranan', 'Initials': 'J', 'LastName': 'Griffiths', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Lakkana', 'Initials': 'L', 'LastName': 'Thaikruea', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand, lakkana.t@cmu.ac.th.'}, {'ForeName': 'Nahathai', 'Initials': 'N', 'LastName': 'Wongpakaran', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Peeraya', 'Initials': 'P', 'LastName': 'Munkhetvit', 'Affiliation': 'Department of Occupational Therapy, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Adisak', 'Initials': 'A', 'LastName': 'Kittisares', 'Affiliation': 'Sriphat Medical Center, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Pairada', 'Initials': 'P', 'LastName': 'Varnado', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}]",Dementia and geriatric cognitive disorders,['10.1159/000507922']
2317,32535646,Patient safety incidents and medication errors during a clinical trial: experience from a pre-hospital randomized controlled trial of emergency medication administration.,"AIM


To assess and evaluate patient safety incidents and in particular, medication errors, during a large multi-center pre-hospital trial of emergency therapy (PARAMEDIC2), in order to inform and improve future pre-hospital medicines trials.
METHODS


The PARAMEDIC2 trial was undertaken across five NHS Ambulance Services in England and Wales with randomisation between December 2014 and October 2017. Patients with an out -of-hospital cardiac arrest unresponsive to initial resuscitation were randomly assigned to 1 mg intravenous adrenaline or matching placebo. Records were reviewed to identify trial medication errors involving documentation and/or clinical protocol errors occurring in trial participants. Causes of medication errors, including root cause analysis where available, were reviewed to identify patterns and themes contributing to these errors.
RESULTS


Eight thousand sixteen patients were enrolled, of whom 4902 received trial medication. A total of 331 patient safety incidents was reported, involving 295 patients, representing an overall rate of 3.6% of these, 166 (50.2%) were documentation errors while 165 (49.8%) were clinical protocol/medication errors. An overall rate of 0-4.5% was reported across all five ambulance services, with a mean of 2.0%. These errors had no impact on patient care or the trial and were all resolved CONCLUSION: The overall medication error rate of 1.8% primarily consisted of administration of open-label adrenaline and confusion with trial medication packs. A similar number of patients had documentation errors. This study is the first to provide data on patient safety incidents relating to medication errors encountered during a pre-hospital trial of emergency medication administration and will provide supporting data for planning future trials in this area.",2020,These errors had no impact on patient care or the trial and were all resolved CONCLUSION: The overall medication error rate of 1.8% primarily consisted of administration of open-label adrenaline and confusion with trial medication packs.,"['Patients with an out -of-hospital cardiac arrest unresponsive to initial resuscitation', 'five NHS Ambulance Services in England and Wales with randomisation between December 2014 and October 2017', 'Eight thousand sixteen patients were enrolled, of whom 4902 received trial medication']",['adrenaline or matching placebo'],"['overall medication error rate', 'overall rate', 'documentation errors']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0002422', 'cui_str': 'Ambulance'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C3840857', 'cui_str': '8000'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0025115', 'cui_str': 'Medication error'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}]",8016.0,0.110179,These errors had no impact on patient care or the trial and were all resolved CONCLUSION: The overall medication error rate of 1.8% primarily consisted of administration of open-label adrenaline and confusion with trial medication packs.,"[{'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'England', 'Affiliation': 'South Central Ambulance Service NHS Foundation Trust, Otterbourne, SO21 2RU, UK.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Deakin', 'Affiliation': 'South Central Ambulance Service NHS Foundation Trust, Otterbourne, SO21 2RU, UK.'}, {'ForeName': 'Jerry P', 'Initials': 'JP', 'LastName': 'Nolan', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Ranjit', 'Initials': 'R', 'LastName': 'Lall', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Quinn', 'Affiliation': ""Kingston University and St George's, University of London, 6th Floor, Hunter Wing, Cranmer Terrace, London, SW17 0RE, UK.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gates', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': 'West Midlands Ambulance Service University NHS Foundation Trust, Brierley Hill, West Midlands, DY5 1LX, UK.'}, {'ForeName': 'Lyndsey', 'Initials': 'L', 'LastName': ""O'Shea"", 'Affiliation': 'Welsh Ambulance Services NHS Trust, Swansea, Wales, SA2 8PP, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Pocock', 'Affiliation': 'South Central Ambulance Service NHS Foundation Trust, Otterbourne, SO21 2RU, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Rees', 'Affiliation': 'Welsh Ambulance Services NHS Trust, Swansea, Wales, SA2 8PP, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Scomparin', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Gavin D', 'Initials': 'GD', 'LastName': 'Perkins', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK. paramedic@warwick.ac.uk.'}]",European journal of clinical pharmacology,['10.1007/s00228-020-02887-z']
2318,32535703,"Diagnostic accuracy of periapical radiograph, cone beam computed tomography, and intrasurgical linear measurement techniques for assessing furcation defects: a longitudinal randomised controlled trial.","OBJECTIVES


The aim of this study was to evaluate the accuracy of cone beam computed tomography (CBCT), periapical radiograph, and intrasurgical linear measurements in the assessment of molars with furcation defects.
MATERIALS AND METHODS


This parallel, single-blinded, randomised controlled trial (RCT) consisted of 22 periodontitis patients who had molar with advanced furcation involvement (FI). All patients followed the same inclusion criteria and were treated following the same protocol, except for radiographic evaluation (CBCT vs. periapical). This study proposed and evaluated five parameters that represent the extent and severity of furcation defects in molars teeth, including CEJ-BD (clinical attachment loss), BL-H (depth), BL-V (height), RT (root trunk), and FW (width).
RESULTS


There were no statistically significant differences between CBCT and intrasurgical linear measurements for any clinical parameter (p > 0.05). However, there were statistically significant differences in BL-V measurements (p < 0.05) between periapical and intrasurgical measurements in maxillary molars. Meanwhile, the sensitivity were 62.8% and 56.9% for CBCT and periapical, respectively.
CONCLUSIONS


Overall, when compared to the intrasurgical measurements, CBCT provided better diagnostic, sensitivity, and quantitative information on CAL, height, depth, and width of the furcation defects than periapical radiograph.
CLINICAL RELEVANCE


An accurate presurgical furcation diagnostic can guide the clinicians from the stage of diagnosis to definitive management so that unnecessary periodontal surgical interventions can be prevented.",2020,"However, there were statistically significant differences in BL-V measurements (p < 0.05) between periapical and intrasurgical measurements in maxillary molars.","['22 periodontitis patients who had molar with advanced furcation involvement (FI', 'molars with furcation defects']","['periapical radiograph, cone beam computed tomography, and intrasurgical linear measurement techniques', 'cone beam computed tomography (CBCT), periapical radiograph, and intrasurgical linear measurements']","['CEJ-BD (clinical attachment loss), BL-H (depth), BL-V (height), RT (root trunk), and FW (width', 'BL-V measurements', 'diagnostic, sensitivity, and quantitative information on CAL, height, depth, and width of the furcation defects']","[{'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0206306', 'cui_str': 'Furcation Defects'}]","[{'cui': 'C0729269', 'cui_str': 'Periapical'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]","[{'cui': 'C0227011', 'cui_str': 'Structure of cementoenamel junction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0206306', 'cui_str': 'Furcation Defects'}]",22.0,0.166803,"However, there were statistically significant differences in BL-V measurements (p < 0.05) between periapical and intrasurgical measurements in maxillary molars.","[{'ForeName': 'Nurul Ain Mohamed', 'Initials': 'NAM', 'LastName': 'Yusof', 'Affiliation': 'Center for Periodontology Studies, Faculty of Dentistry, Universiti Teknologi MARA, Sungai Buloh Campus, 47000, Sungai Buloh, Selangor, Malaysia. ainyusof12@yahoo.com.'}, {'ForeName': 'Erni', 'Initials': 'E', 'LastName': 'Noor', 'Affiliation': 'Center for Periodontology Studies, Faculty of Dentistry, Universiti Teknologi MARA, Sungai Buloh Campus, 47000, Sungai Buloh, Selangor, Malaysia.'}, {'ForeName': 'Nor Hidayah', 'Initials': 'NH', 'LastName': 'Reduwan', 'Affiliation': 'Center for Oral and Maxillofacial Diagnostics and Medicine Studies, Faculty of Dentistry, Universiti Teknologi MARA, Sungai Buloh Campus, 47000, Sungai Buloh, Selangor, Malaysia.'}, {'ForeName': 'Mohd Yusmiaidil Putera Mohd', 'Initials': 'MYPM', 'LastName': 'Yusof', 'Affiliation': 'Center for Oral and Maxillofacial Diagnostics and Medicine Studies, Faculty of Dentistry, Universiti Teknologi MARA, Sungai Buloh Campus, 47000, Sungai Buloh, Selangor, Malaysia.'}]",Clinical oral investigations,['10.1007/s00784-020-03380-8']
2319,32535719,The Effect of Mindfulness-Based Psychosocial Skills Training on Functioning and Insight Level in Patients with Schizophrenia.,"This study aims to determine the effect of mindfulness-based psychosocial skills training (MBPST) on the functional recovery and insight level in patients with schizophrenia. In this study, 40 patients with schizophrenia registered in the Aksaray Community Mental Health Centre were divided into two groups: the intervention group (n = 20) and the non-intervention group (n = 20). The Functional Recovery Scale in Schizophrenia (FRSS) and the Beck Cognitive Insight Scale (BCIS) were measured at preintervention and postintervention. The posttest mean scores of FRSS and BCIS of the intervention group were statistically higher than the non-intervention group (p < 0.05). The MBPST program improved functional recovery and cognitive insight in schizophrenia. In line with these results, it has been recommended that MBPST program should be provided along with medical treatment in Community Mental Health Centres.",2020,The posttest mean scores of FRSS and BCIS of the intervention group were statistically higher than the non-intervention group (p < 0.05).,"['patients with schizophrenia', 'Patients with Schizophrenia', '40 patients with schizophrenia registered in the Aksaray Community Mental Health Centre']","['Mindfulness-Based Psychosocial Skills Training', 'MBPST', 'mindfulness-based psychosocial skills training (MBPST']","['functional recovery and cognitive insight in schizophrenia', 'Functional Recovery Scale in Schizophrenia (FRSS) and the Beck Cognitive Insight Scale (BCIS', 'Functioning and Insight Level', 'posttest mean scores of FRSS and BCIS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}]","[{'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0233820', 'cui_str': 'Insight'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",40.0,0.014262,The posttest mean scores of FRSS and BCIS of the intervention group were statistically higher than the non-intervention group (p < 0.05).,"[{'ForeName': 'Arzu', 'Initials': 'A', 'LastName': 'Yüksel', 'Affiliation': 'Department of Psychiatric Nursing, Faculty of Health Sciences, Aksaray University, Aksaray, Turkey.'}, {'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Bahadır-Yılmaz', 'Affiliation': 'Department of Psychiatric Nursing, Faculty of Health Sciences, Giresun University, 28340, Giresun, Turkey. ebahadiryilmaz@yahoo.com.'}]",Community mental health journal,['10.1007/s10597-020-00658-9']
2320,32535742,Bioequivalence of Ultra Rapid Lispro (URLi) U100 and U200 Formulations in Healthy Subjects.,"INTRODUCTION


Ultra rapid lispro (URLi) is a novel insulin lispro formulation that was developed to more closely match physiological insulin secretion. The aims of this study were to demonstrate the bioequivalence (BE) of a concentrated formulation (U200) of URLi to the U100 formulation of URLi after subcutaneous (SC) administration and to evaluate the glucodynamics (GD) of these formulations.
METHODS


This phase 1, randomized, two-sequence, four-period, double-blind, replicate crossover study was conducted in 68 healthy subjects. At each dosing visit, subjects received a 15-U SC dose of either U100 URLi or U200 URLi followed by a 10-h euglycemic clamp procedure. Serum insulin lispro and blood glucose concentrations were measured, and the glucose infusion rate was continuously adjusted during the clamp to maintain the target blood glucose.
RESULTS


Bioequivalence of U200 URLi relative to U100 URLi was demonstrated. The 90% confidence intervals (CIs) of the ratios of geometric least squares (LS) means for the maximum insulin concentration and total exposure were within the BE limits of 0.80-1.25. Additionally, the 90% CIs for the ratios of geometric LS means for maximum glucose infusion rate and total glucose infused were within the BE limits. The early 50% t max  occurred at approximately the same time for the U100 and U200 URLi formulations, and the insulin exposure within the first 15 min was similar for both formulations. The tolerability of the two URLi formulations was comparable.
CONCLUSIONS


This study demonstrated that the U100 and U200 URLi formulations are bioequivalent. The accelerated insulin absorption observed for the U100 formulation was maintained with the U200 URLi formulation. Further, the GD were similar for both formulations, supporting the ability of individuals to transfer from U100 to U200 URLi in a 1:1 unit conversion.
TRIAL REGISTRATION


NCT03616977.",2020,"The tolerability of the two URLi formulations was comparable.
","['68 healthy subjects', 'Healthy Subjects']","['Ultra Rapid Lispro (URLi) U100 and U200 Formulations', 'Ultra rapid lispro (URLi', '15-U SC dose of either U100 URLi or U200 URLi followed by a 10-h euglycemic clamp procedure']","['accelerated insulin absorption', 'maximum glucose infusion rate and total glucose', 'Serum insulin lispro and blood glucose concentrations', 'glucose infusion rate']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}]",68.0,0.0625239,"The tolerability of the two URLi formulations was comparable.
","[{'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Linnebjerg', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Elizabeth Smith', 'Initials': 'ES', 'LastName': 'LaBell', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Mary Anne', 'Initials': 'MA', 'LastName': 'Dellva', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Coutant', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Leohr', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA. leohr_jennifer_k@lilly.com.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00848-4']
2321,32535786,The Protective Effects of Butorphanol on Pulmonary Function of Patients with Obesity Undergoing Laparoscopic Bariatric Surgery: a Double-Blind Randomized Controlled Trial.,"BACKGROUND


Obesity is a risk factor for postoperative pulmonary complications (PPCs). Recent studies have reported the pulmonary protective role of the kappa opioid receptor (KOR). Butorphanol is a narcotic with strong KOR agonist action, and the role in pulmonary protection is uncertain. Here, we hypothesized that butorphanol exerts protective effects on pulmonary function in patients with obesity undergoing laparoscopic bariatric surgery.
METHODS


Patients with a body mass index ≥ 30 kg/m 2  scheduled for laparoscopic bariatric surgery were randomized to receive butorphanol or normal saline. Butorphanol was administered as an initial loading dose of 10 μg/kg at 5 min before induction followed by 5 μg/(kg h) during surgery. The primary outcome was arterial-alveolar oxygen tension ratio (a/A ratio). Secondary outcomes included other pulmonary variables, biomarkers reflecting pulmonary injury, and incidence of PPCs within 7 days after surgery.
RESULTS


Patients in the butorphanol group had a significantly higher a/A ratio at 1 h after the operation began (68 ± 7 vs. 55 ± 8, P < 0.001), end of the operation (73 ± 8 vs. 59 ± 7, P < 0.001), and 1 h after extubation (83 ± 9 vs. 70 ± 5, P < 0.001) compared with those in the control group. In addition, in the butorphanol group, dead space to tidal volume ratios were significantly lower than those in the control group at the same time points (all P < 0.001). In the control group, the levels of biomarkers reflecting pulmonary injury were significantly higher than those in the butorphanol group at 3 h, 6 h, 12 h, and 24 h postoperatively (P < 0.001). The incidence of PPCs was similar in both groups.
CONCLUSION


Butorphanol administration protected pulmonary function by improving oxygenation and reducing dead space ventilation in patients with obesity undergoing laparoscopic bariatric surgery. Butorphanol may therefore provide clinical benefits in patients with obesity.",2020,"In the control group, the levels of biomarkers reflecting pulmonary injury were significantly higher than those in the butorphanol group at 3 h, 6 h, 12 h, and 24 h postoperatively (P < 0.001).","['m 2  scheduled for laparoscopic bariatric surgery', 'Patients with a body mass index ≥', 'patients with obesity undergoing laparoscopic bariatric surgery', 'patients with obesity', 'Patients with Obesity Undergoing Laparoscopic Bariatric Surgery']","['butorphanol', 'Butorphanol', 'butorphanol or normal saline']","['Pulmonary Function', 'arterial-alveolar oxygen tension ratio (a/A ratio', 'pulmonary variables, biomarkers reflecting pulmonary injury, and incidence of PPCs within 7\xa0days after surgery', 'dead space ventilation', 'pulmonary function', 'dead space to tidal volume ratios', 'incidence of PPCs', 'levels of biomarkers reflecting pulmonary injury']","[{'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0006491', 'cui_str': 'Butorphanol'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0273115', 'cui_str': 'Injury of lung'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.433438,"In the control group, the levels of biomarkers reflecting pulmonary injury were significantly higher than those in the butorphanol group at 3 h, 6 h, 12 h, and 24 h postoperatively (P < 0.001).","[{'ForeName': 'Xiu-Li', 'Initials': 'XL', 'LastName': 'Wang', 'Affiliation': 'Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Zeng', 'Affiliation': ""Department of Anesthesiology, Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, Sichuan, China.""}, {'ForeName': 'Xiao-Xiao', 'Initials': 'XX', 'LastName': 'Li', 'Affiliation': 'Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Xing-He', 'Initials': 'XH', 'LastName': 'Wang', 'Affiliation': 'Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China. w15996933165@163.com.'}]",Obesity surgery,['10.1007/s11695-020-04755-2']
2322,32535812,"First-in-human, phase I single-ascending-dose study of the safety, pharmacokinetics, and relative bioavailability of selatinib, a dual EGFR-ErbB2 inhibitor in healthy subjects.","We assessed the pharmacokinetics and safety of a single oral administration of selatinib to healthy Chinese subjects and evaluated the potential bioavailability advantage of selatinib relative to lapatinib. Healthy subjects aged 18-40 years were enrolled in this two-part study: Part 1, a single ascending dose (50-500 mg), randomized, double-blind, placebo-control study with 64 subjects; and Part 2, an open-label, positive control, randomized, three-treatment, three-period, three-sequence crossover design study, with 6 subjects administered a single 500-mg dose of selatinib tablets (A), selatinib suspension (B), or lapatinib tablets C) per cycle. In part 1, selatinib was well-tolerated up to the planned maximum dose of 500 mg; thus the maximum tolerated dose was not attained. Twenty-two adverse events were observed in 19 (36.5%) of the 52 subjects administered the test drug. The most common drug-related adverse event was diarrhea. The mean selatinib peak plasma concentration was 69.4-494 ng/mL, which was achieved in a median peak time of 3.5-4.5 h, with a mean elimination half-life between 13.8 and 15.8 h. In Part 2, A and B showed similar bioavailability. Plasma exposure to the active drug (selatinib plus the metabolite, lapatinib) after A intake was more than two-fold higher than that of the same dose of C. In the dose range of 50-500 mg, selatinib was safe and well-tolerated by healthy Chinese subjects, and it conformed with linear pharmacokinetics. Active exposure to selatinib was much greater than that to lapatinib, supporting its development as an adjuvant for anticancer treatment.",2020,Twenty-two adverse events were observed in 19 (36.5%) of the 52 subjects administered the test drug.,"['Healthy subjects aged 18-40\xa0years', 'healthy Chinese subjects', 'healthy subjects']","['placebo-control study with 64 subjects; and Part 2, an open-label, positive control', 'selatinib tablets (A), selatinib suspension (B), or lapatinib tablets C', 'lapatinib']","['mean selatinib peak plasma concentration', 'pharmacokinetics and safety', 'safe and well-tolerated', 'bioavailability', 'adverse events']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C3852885', 'cui_str': 'selatinib'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C1813640', 'cui_str': 'lapatinib Oral Tablet'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3852885', 'cui_str': 'selatinib'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0590034,Twenty-two adverse events were observed in 19 (36.5%) of the 52 subjects administered the test drug.,"[{'ForeName': 'Meng-Na', 'Initials': 'MN', 'LastName': 'Wang', 'Affiliation': ""Center for Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, 410013, People's Republic of China.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Kuang', 'Affiliation': ""Center for Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, 410013, People's Republic of China.""}, {'ForeName': 'Li-Ying', 'Initials': 'LY', 'LastName': 'Gong', 'Affiliation': ""Center for Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, 410013, People's Republic of China.""}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Hua', 'Affiliation': ""Center for Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, 410013, People's Republic of China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Pei', 'Affiliation': ""Department of Pharmacy, The Third Xiangya Hospital, Central South University, Changsha, Hunan, 410013, People's Republic of China.""}, {'ForeName': 'Cheng-Xian', 'Initials': 'CX', 'LastName': 'Guo', 'Affiliation': ""Center for Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, 410013, People's Republic of China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': ""Department of Cardiology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, 410013, People's Republic of China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': ""Center for Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, 410013, People's Republic of China. cellahuang1988@163.com.""}, {'ForeName': 'Guo-Ping', 'Initials': 'GP', 'LastName': 'Yang', 'Affiliation': ""Center for Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, 410013, People's Republic of China. ygp9880@126.com.""}]",Investigational new drugs,['10.1007/s10637-020-00959-6']
2323,32535984,Impact of parents' mental health-related stigma on their adolescent children's response to anti-stigma interventions over 24 months: secondary exploratory analysis of a randomized controlled trial.,,2020,,"[""parents' mental health-related stigma on their adolescent children's""]",['anti-stigma interventions'],[],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.193345,,"[{'ForeName': 'Yasutaka', 'Initials': 'Y', 'LastName': 'Ojio', 'Affiliation': 'Center for Evolutionary Cognitive Sciences, Graduate School of Arts and Sciences, The University of Tokyo, 3-8-1 Komaba, Meguro-ku, Tokyo, 153-8902, Japan.'}, {'ForeName': 'Sosei', 'Initials': 'S', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Community Mental Health & Law, National Institute of Mental Health, National Center of Neurology and Psychiatry, Kodaira, Tokyo, 187-8553, Japan.'}, {'ForeName': 'Shuntaro', 'Initials': 'S', 'LastName': 'Ando', 'Affiliation': 'Department of Neuropsychiatry, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Koike', 'Affiliation': 'Center for Evolutionary Cognitive Sciences, Graduate School of Arts and Sciences, The University of Tokyo, 3-8-1 Komaba, Meguro-ku, Tokyo, 153-8902, Japan.'}]",Psychiatry and clinical neurosciences,['10.1111/pcn.13085']
2324,32536000,Impact of inferior caval valve implantation on severity of tricuspid regurgitation and right heart function.,"AIMS


Severe tricuspid regurgitation (TR) is a common finding in heart failure patients and associated with increased mortality. New interventional therapeutic options are needed as many heart failure patients are unfit for surgery. The TRICAVAL study compared valve implantation into the inferior vena cava (CAVI) with optimal medical therapy (OMT) in patients with severe TR. Here, we report details on the impact of CAVI on TR severity as well as right heart function and morphology.
METHODS AND RESULTS


We randomized 28 patients with severe TR to CAVI (n = 14) with transfemoral implantation of an Edwards Sapien XT valve into the inferior vena cava or OMT (n = 14). Inclusion and exclusion criteria were based on anatomical and clinical parameters. Echocardiographic measurements were performed at baseline, at the first postoperative day and one, three, and twelve months after randomization. As proof of concept of an effective sealing of the inferior vena cava, we detected a significant decrease in systolic hepatic vein reflux volume (11.0 [6.2-21.9] mL vs 3.5 [0.6-8.5] mL, P = .016) and hepatic vein diameter (11.5 [10.0-14.8] mm vs 10.0 [9.3-11.8] mm, P = .034) at thirty-day follow-up. However, CAVI had no significant impact on TR, cardiac function, and morphology.
CONCLUSIONS


Caval valve implantation significantly reduced systolic reflux into the hepatic veins but was not associated with an improvement in cardiac function, morphology, or TR severity.",2020,"CONCLUSIONS


Caval valve implantation significantly reduced systolic reflux into the hepatic veins but was not associated with an improvement in cardiac function, morphology, or TR severity.","['heart failure patients', 'patients with severe TR', '28 patients with severe TR to CAVI (n\xa0=\xa014) with', 'n\xa0=\xa014']","['valve implantation into the inferior vena cava (CAVI) with optimal medical therapy (OMT', 'inferior caval valve implantation', 'transfemoral implantation of an Edwards Sapien XT valve into the inferior vena cava or OMT']","['Echocardiographic measurements', 'hepatic vein diameter', 'Severe tricuspid regurgitation (TR', 'systolic reflux', 'severity of tricuspid regurgitation and right heart function', 'systolic hepatic vein reflux volume', 'TR, cardiac function, and morphology', 'cardiac function, morphology, or TR severity']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040961', 'cui_str': 'Tricuspid valve regurgitation'}, {'cui': 'C0085979', 'cui_str': 'Genus Cavia'}]","[{'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0042458', 'cui_str': 'Inferior vena cava structure'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0152096', 'cui_str': 'Complete trisomy 18 syndrome'}]","[{'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0019155', 'cui_str': 'Structure of hepatic vein'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040961', 'cui_str': 'Tricuspid valve regurgitation'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0225808', 'cui_str': 'Structure of right side of heart'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}]",28.0,0.0584031,"CONCLUSIONS


Caval valve implantation significantly reduced systolic reflux into the hepatic veins but was not associated with an improvement in cardiac function, morphology, or TR severity.","[{'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Mattig', 'Affiliation': 'Medizinische Klinik mit Schwerpunkt Kardiologie und Angiologie, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Knebel', 'Affiliation': 'Medizinische Klinik mit Schwerpunkt Kardiologie und Angiologie, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Hewing', 'Affiliation': 'Medizinische Klinik mit Schwerpunkt Kardiologie und Angiologie, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Stangl', 'Affiliation': 'Medizinische Klinik mit Schwerpunkt Kardiologie und Angiologie, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Stangl', 'Affiliation': 'Medizinische Klinik mit Schwerpunkt Kardiologie und Angiologie, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Laule', 'Affiliation': 'Medizinische Klinik mit Schwerpunkt Kardiologie und Angiologie, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Henryk', 'Initials': 'H', 'LastName': 'Dreger', 'Affiliation': 'Medizinische Klinik mit Schwerpunkt Kardiologie und Angiologie, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}]","Echocardiography (Mount Kisco, N.Y.)",['10.1111/echo.14760']
2325,32536013,"Health-Related Quality of Life in MONARCH 3: Abemaciclib Plus an Aromatase Inhibitor as Initial Therapy in HR+, HER2- Advanced Breast Cancer.","BACKGROUND


MONARCH 3, a phase III trial (NCT02246621) of postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC), previously demonstrated significantly improved progression-free survival in patients receiving abemaciclib plus a nonsteroidal aromatase inhibitor (NSAI). This study evaluated patient-reported outcomes, including global health-related quality of life (HRQoL), functioning, and symptoms.
METHODS


Patients were randomly assigned 2:1 to receive abemaciclib (150 mg twice daily; n = 328) or placebo (n = 165), plus 1 mg anastrozole or 2.5 mg letrozole daily. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and Breast Cancer-Specific Quality of Life Questionnaire HRQoL instruments were administered at baseline, every two cycles during cycles 2 through 19 (each cycle being 28 days), every three cycles thereafter, and once at a short-term posttherapy follow-up visit (approximately 30 days after discontinuation). Longitudinal mixed regression and Cox proportional hazards models evaluated postbaseline change and time to sustained deterioration (TTSD), respectively.
RESULTS


Baseline scores were similar between treatment arms. Although select scores statistically favored the placebo arm, global HRQoL, most symptoms, and functioning scales did not meet the threshold for clinically meaningful differences between treatment arms. Only diarrhea favored the placebo arm with statistically and clinically meaningful differences. There were no TTSD differences between treatment arms for global HRQoL, most symptoms (except diarrhea), or functioning.
CONCLUSION


Over a 2-year period, there were no clinically meaningful differences in global HRQoL, functioning, and most symptoms for patients receiving abemaciclib plus NSAI compared with NSAI alone. Only diarrhea favored the placebo arm, consistent with prior safety data, which has been shown to be manageable and reversible. Combined with clinical efficacy, results support treatment with abemaciclib plus NSAI for postmenopausal women with HR+, HER2- ABC.
IMPLICATIONS FOR PRACTICE


The addition of abemaciclib to a nonsteroidal aromatase inhibitor (NSAI) was not associated with a clinically meaningful detriment in patient-reported global health-related quality of life, functioning, and most symptoms in postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC). Prior studies have also demonstrated clinical efficacy of abemaciclib plus NSAI compared with NSAI alone, including improved progression-free survival and objective response rate. These results also complement previously reported toxicity data, as measured by investigator-assessed adverse events. Taken together, these results support treatment with abemaciclib plus NSAI for postmenopausal women with HR+, HER2- ABC.",2020,", there were no clinically meaningful differences in global HRQoL, functioning, and most symptoms for patients receiving abemaciclib plus NSAI compared with NSAI alone.","['patients receiving abemaciclib plus a nonsteroidal aromatase inhibitor (NSAI', 'postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC', 'MONARCH 3', 'postmenopausal women with HR+, HER2- ABC', 'Patients', 'HR+, HER2- Advanced Breast Cancer']","['anastrozole or 2.5 mg letrozole daily', 'abemaciclib', 'Abemaciclib Plus an Aromatase Inhibitor', 'nonsteroidal aromatase inhibitor (NSAI', 'abemaciclib plus NSAI', 'placebo']","['global health-related quality of life (HRQoL), functioning, and symptoms', 'diarrhea', 'progression-free survival and objective response rate', 'global HRQoL, most symptoms, and functioning scales', 'global HRQoL, most symptoms (except diarrhea), or functioning', 'toxicity data', 'Cancer Quality of Life Questionnaire Core 30 and Breast Cancer-Specific Quality of Life Questionnaire HRQoL instruments', 'global HRQoL, functioning, and most symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3852841', 'cui_str': 'abemaciclib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}]","[{'cui': 'C0290883', 'cui_str': 'anastrozole'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3852841', 'cui_str': 'abemaciclib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}]",,0.301533,", there were no clinically meaningful differences in global HRQoL, functioning, and most symptoms for patients receiving abemaciclib plus NSAI compared with NSAI alone.","[{'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Goetz', 'Affiliation': 'Division of Medical Oncology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Instituto de Investigacion Sanitaria Gregorio Marañon, Ciberonc, Geicam, Universidad Complutense, Madrid, Spain.'}, {'ForeName': 'Eriko', 'Initials': 'E', 'LastName': 'Tokunaga', 'Affiliation': 'National Hospital Organization, Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'In Hae', 'Initials': 'IH', 'LastName': 'Park', 'Affiliation': 'National Cancer Center, Gyeonggi-Do, Republic of South Korea.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Huober', 'Affiliation': 'Breast Center, Universitätsklinikum Ulm, Ulm, Germany.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Toi', 'Affiliation': 'Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Stoffregen', 'Affiliation': 'Eli Lilly & Co., Bad Homburg, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Shekarriz', 'Affiliation': 'Eli Lilly & Co., Bad Homburg, Germany.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Andre', 'Affiliation': 'Eli Lilly & Co., Paris, France.'}, {'ForeName': 'M Corona', 'Initials': 'MC', 'LastName': 'Gainford', 'Affiliation': 'Eli Lilly & Co., Indianapolis, Indiana, USA.'}, {'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Price', 'Affiliation': 'Eli Lilly & Co., Indianapolis, Indiana, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Johnston', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, London, United Kingdom.'}]",The oncologist,['10.1634/theoncologist.2020-0084']
2326,32536019,"Vaginal compared with intramuscular progestogen for preventing preterm birth in high-risk pregnant women (VICTORIA study); a multicentre, open-label randomised trial and a meta-analysis.","OBJECTIVE


To compare the efficacy of two types of progestogen therapy for preventing preterm birth (PTB) and review of the relevant literature.
DESIGN


A multicentre, randomised, open-label, equivalence trial and a meta-analysis. Setting Tertiary referral hospitals in South Korea. Population Pregnant women with history of spontaneous PTB or short cervical length (<25 mm).
METHODS


Eligible women were screened and randomised at 16-22 weeks of gestation to either receive 200 mg vaginal micronised progesterone daily (vaginal group) or intramuscular injection of 250 mg 17α-hydroxyprogesterone caproate weekly (IM group). Stratified randomisation was carried out according to participating centres and indications of progestogen therapy. This trial was registered at ClinicalTrials.gov (NCT02304237). Main outcome measures PTB before 37 weeks of gestation.
RESULTS


A total of 266 women were randomly assigned and a total of 247 (119 and 128 women in the vaginal and IM groups, respectively) were available for the intention-to-treat analysis. Risks of PTB before 37 weeks of gestation were not significantly different between the two groups (22.7% versus 25.8%, P = 0.571). The difference in the PTB risk between the two groups was 3.1% (95% CI -7.6 to 13.8%) which was within the equivalence margin of 15%. The meta-analysis results showed no significant differences in the risk of PTB between the vaginal and IM progestogen treatments.
CONCLUSION


Treatment with intramuscular progestin compared with vaginal progesterone might increase risk of PTB before 37 weeks of gestation by as much as 13.8% or reduce it by as much as 7.6% in women with a history of spontaneous PTB or short cervical length.",2020,"The meta-analysis results showed no significant differences in the risk of PTB between the vaginal and IM progestogen treatments.
","['Setting Tertiary referral hospitals in South Korea', 'Population Pregnant women with history of spontaneous PTB or short cervical length (<25 mm', 'high-risk pregnant women', 'Eligible women', 'A total of 266 women were randomly assigned and a total of 247 (119 and 128 women in the vaginal and IM groups, respectively) were available for the intention-to-treat analysis']","['intramuscular progestin', '200 mg vaginal micronised progesterone daily (vaginal group) or intramuscular injection of 250 mg 17α-hydroxyprogesterone caproate', 'progestogen therapy', 'intramuscular progestogen']","['Risks of PTB', 'PTB risk', 'preterm birth', 'preterm birth (PTB', 'risk of PTB']","[{'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0033306', 'cui_str': 'Progestational hormone'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0044971', 'cui_str': 'Hydroxyprogesterone caproate'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}]",266.0,0.445353,"The meta-analysis results showed no significant differences in the risk of PTB between the vaginal and IM progestogen treatments.
","[{'ForeName': 'S-J', 'Initials': 'SJ', 'LastName': 'Choi', 'Affiliation': 'Samsung Medical Centre, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'D W', 'Initials': 'DW', 'LastName': 'Kwak', 'Affiliation': 'Ajou University School of Medicine, Suwon, Republic of Korea.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kil', 'Affiliation': ""Yeouido St Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'S-C', 'Initials': 'SC', 'LastName': 'Kim', 'Affiliation': 'Pusan National University College of Medicine, Pusan, Republic of Korea.'}, {'ForeName': 'J-Y', 'Initials': 'JY', 'LastName': 'Kwon', 'Affiliation': ""Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, Republic of Korea.""}, {'ForeName': 'Y H', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Na', 'Affiliation': 'Kangwon National University Hospital, School of Medicine, Kangwon National University, Chuncheon, Republic of Korea.'}, {'ForeName': 'J-G', 'Initials': 'JG', 'LastName': 'Bae', 'Affiliation': 'Keimyung University School of Medicine, Daegu, Republic of Korea.'}, {'ForeName': 'H-H', 'Initials': 'HH', 'LastName': 'Cha', 'Affiliation': 'Kyungpook National University Hospital, Kyungpook National University School of Medicine, Daegu, Republic of Korea.'}, {'ForeName': 'J-Y', 'Initials': 'JY', 'LastName': 'Shim', 'Affiliation': 'Asan Medical Centre, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'K Y', 'Initials': 'KY', 'LastName': 'Oh', 'Affiliation': 'School of Medicine, Eulji University, Daejeon, Republic of Korea.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Lee', 'Affiliation': 'Kyung Hee University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Kim', 'Affiliation': 'Seoul Metropolitan Government Seoul National University Boramae Medical Centre, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'I A', 'Initials': 'IA', 'LastName': 'Cho', 'Affiliation': 'Gyeongsang National University Hospital, Gyeongsang National University School of Medicine, Jinju, Republic of Korea.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Lee', 'Affiliation': 'Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Cho', 'Affiliation': 'Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Y S', 'Initials': 'YS', 'LastName': 'Jo', 'Affiliation': ""St Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Republic of Korea.""}, {'ForeName': 'G Y', 'Initials': 'GY', 'LastName': 'Choi', 'Affiliation': 'Soonchunhyang University Seoul Hospital, College of Medicine, Soonchunhyang University, Seoul, Republic of Korea.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Choi', 'Affiliation': 'College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'Hur', 'Affiliation': 'Konyang University Hospital, Daejeon, Republic of Korea.'}, {'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Hwang', 'Affiliation': 'Research Institute of Medical Science, Konkuk University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Y J', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'College of Medicine, Ewha Womans University, Seoul, Republic of Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16365']
2327,32536023,"Human milk oligosaccharide supplementation in irritable bowel syndrome patients: A parallel, randomized, double-blind, placebo-controlled study.","OBJECTIVES


Human milk oligosaccharides safely and beneficially impact bifidobacteria abundance in healthy adults, while their effects in patients with irritable bowel syndrome (IBS) are unknown. Hence, we aimed to determine the dose of 4:1 mix of 2'-O-fucosyllactose and Lacto-N-neotetraose (2'FL/LNnT) that increases fecal bifidobacteria abundance without aggravating overall gastrointestinal symptoms in IBS patients in a randomized, double-blind, controlled study. Additionally, the impact of 2'FL/LNnT on the fecal bacterial profile was assessed.
METHODS


Irritable bowel syndrome patients diagnosed according to the Rome IV criteria received placebo (glucose), or 5 g or 10 g 2'FL/LNnT for 4 weeks followed by a four-week follow-up period. Gastrointestinal Symptom Rating Scale-IBS was used to assess gastrointestinal symptom severity; fecal microbiota composition was evaluated by GA-map™ Dysbiosis Test.
RESULTS


Of the included 60 patients, two (one placebo and one 10 g) discontinued prematurely. Fecal bifidobacteria abundance was increased at week 4, but not at week 8, in the 10 g group compared to the other groups. Severity of overall or individual gastrointestinal symptoms did not differ between the groups at week 4 or 8, and no symptom deterioration was seen in any of the groups. The 10 g dose influenced overall fecal microbiota composition, and responders-defined as bifidobacteria increase ≥50%-could be discriminated from non-responders based on fecal microbiota modulation.
CONCLUSIONS


The 10 g dose of 2'FL/LNnT induced an increase in the beneficial Bifidobacterium spp. without aggravating gastrointestinal symptoms in patients with IBS. This approach may be worthwhile to modulate gut microbiota of IBS patients toward a healthier profile.",2020,"Severity of overall or individual gastrointestinal symptoms did not differ between the groups at week 4 or 8, and no symptom deterioration was seen in any of the groups.","['Irritable bowel syndrome patients diagnosed according to the Rome IV criteria received', 'IBS patients', 'patients with irritable bowel syndrome (IBS', 'healthy adults', 'irritable bowel syndrome patients', 'patients with IBS']","['Human milk oligosaccharide supplementation', ""placebo (glucose), or 5\xa0g or 10\xa0g 2'FL/LNnT"", ""2'-O-fucosyllactose and Lacto-N-neotetraose (2'FL/LNnT"", ""2'FL/LNnT"", 'placebo']","['gastrointestinal symptom severity; fecal microbiota composition', 'Fecal bifidobacteria abundance', 'Severity of overall or individual gastrointestinal symptoms', 'fecal bifidobacteria abundance', 'fecal bacterial profile', 'overall fecal microbiota composition', 'symptom deterioration', 'Gastrointestinal Symptom Rating Scale-IBS']","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0026140', 'cui_str': 'Breast milk'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharide'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0064595', 'cui_str': 'lacto-N-neotetraose'}]","[{'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}]",60.0,0.247149,"Severity of overall or individual gastrointestinal symptoms did not differ between the groups at week 4 or 8, and no symptom deterioration was seen in any of the groups.","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Iribarren', 'Affiliation': 'Department of Microbiology and Immunology, Institute of Biomedicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Törnblom', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Aziz', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Maria K', 'Initials': 'MK', 'LastName': 'Magnusson', 'Affiliation': 'Department of Microbiology and Immunology, Institute of Biomedicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Sundin', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Louise K', 'Initials': 'LK', 'LastName': 'Vigsnaes', 'Affiliation': 'Glycom A/S, Hørsholm, Denmark.'}, {'ForeName': 'Ingvild Dybdrodt', 'Initials': 'ID', 'LastName': 'Amundsen', 'Affiliation': 'Glycom A/S, Hørsholm, Denmark.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'McConnell', 'Affiliation': 'Glycom A/S, Hørsholm, Denmark.'}, {'ForeName': 'Dorthe', 'Initials': 'D', 'LastName': 'Seitzberg', 'Affiliation': 'Glycom A/S, Hørsholm, Denmark.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Öhman', 'Affiliation': 'Department of Microbiology and Immunology, Institute of Biomedicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Simrén', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.13920']
2328,32536026,"Progressive Muscle Relaxation and Mindfulness Meditation on Neuropathic Pain, Fatigue, and Quality of Life in Patients With Type 2 Diabetes: A Randomized Clinical Trial.","PURPOSE


To examine the effects of progressive muscle relaxation and mindfulness meditation on the severity of diabetic peripheral neuropathic pain (DPNP), fatigue, and quality of life in patients with type 2 diabetes.
DESIGN


An assessor-blinded prospective randomized controlled trial.
METHODS


Participants were randomly assigned to the relaxation group (RG; n = 28), meditation group (MG; n = 25), or control group (CG; n = 24). The mean age of participants was 64.2 ± 8.1 years in the RG, 61.6 ± 8.0 years in the MG, and 64.1± 6.6 years in the CG. Patients in the intervention groups performed progressive muscle relaxation or mindfulness meditation at their home for 12 weeks, 20 min daily. The CG received only an attention-matched controlled education on pancreas anatomy and diabetes. Data collection was performed at baseline and at weeks 12 and 14 using the VAS, FACIT Fatigue Scale (FACIT-F), and Neuropathic Pain Impact on Quality of Life Questionnaire (NePIQoL).
FINDINGS


VAS scores were significantly lower in the RG and MG at week 12 (p < .05) and were statistically significant in the RG at week 14. Additionally, fatigue severity decreased significantly in the RG at weeks 12 and 14, compared to that in the CG (p < .05). While no significant difference was found in the quality of life scores between the study groups at weeks 12 and 14 (p > .05), a significant improvement in quality of life scores in the RG were provided at week 12 compared to those at baseline and week 14 (p < .05).
CONCLUSIONS


Both progressive muscle relaxation and mindfulness meditation had a positive impact on providing pain relief in patients with DPNP. Moreover, progressive muscle relaxation also appeared to have a beneficial effect on fatigue.
CLINICAL RELEVANCE


Based on the results, progressive muscle relaxation and mindfulness meditation can be recommended as supportive therapies for the management of DPNP.",2020,"FINDINGS


VAS scores were significantly lower in the RG and MG at week 12 (p < .05) and were statistically significant in the RG at week 14.","['patients with DPNP', 'The mean age of participants was 64.2 ± 8.1 years in the RG, 61.6 ± 8.0 years in the MG, and 64.1± 6.6 years in the CG', 'Patients With Type 2 Diabetes', 'Participants', 'patients with type 2 diabetes']","['mindfulness meditation', 'relaxation group (RG; n = 28), meditation group (MG', 'attention-matched controlled education', 'progressive muscle relaxation and mindfulness meditation', 'progressive muscle relaxation or mindfulness meditation', 'Progressive Muscle Relaxation and Mindfulness Meditation']","['pain relief', 'VAS, FACIT Fatigue Scale (FACIT-F), and Neuropathic Pain Impact on Quality of Life Questionnaire (NePIQoL', 'fatigue severity', 'quality of life scores', 'diabetic peripheral neuropathic pain (DPNP), fatigue, and quality of life', 'Neuropathic Pain, Fatigue, and Quality of Life', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1963916', 'cui_str': 'Diabetic peripheral neuropathic pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517823', 'cui_str': '6.6'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1963916', 'cui_str': 'Diabetic peripheral neuropathic pain'}]",28.0,0.0250056,"FINDINGS


VAS scores were significantly lower in the RG and MG at week 12 (p < .05) and were statistically significant in the RG at week 14.","[{'ForeName': 'Nur', 'Initials': 'N', 'LastName': 'Izgu', 'Affiliation': 'Assistant Professor, Hacettepe University Faculty of Nursing, Internal Medicine Nursing Department, Ankara, Turkey.'}, {'ForeName': 'Zehra', 'Initials': 'Z', 'LastName': 'Gok Metin', 'Affiliation': 'Associate Professor, Hacettepe University Faculty of Nursing, Internal Medicine Nursing Department, Ankara, Turkey.'}, {'ForeName': 'Canan', 'Initials': 'C', 'LastName': 'Karadas', 'Affiliation': 'Research Assistant, Hacettepe University Faculty of Nursing, Internal Medicine Nursing Department, Ankara, Turkey.'}, {'ForeName': 'Leyla', 'Initials': 'L', 'LastName': 'Ozdemir', 'Affiliation': 'Professor, Hacettepe University Faculty of Nursing, Internal Medicine Nursing Department, Ankara, Turkey.'}, {'ForeName': 'Nuran', 'Initials': 'N', 'LastName': 'Metinarikan', 'Affiliation': 'Ankara University School of Medicine Ibni Sina Hospital, Endocrinolocy and Metabolic Diseases Outpatient Unit, Ankara, Turkey.'}, {'ForeName': 'Demet', 'Initials': 'D', 'LastName': 'Corapcıoglu', 'Affiliation': 'Professor, Ankara University School of Medicine Ibni Sina Hospital, Department of Endocrinology and Metabolic Diseases, Ankara, Turkey.'}]",Journal of nursing scholarship : an official publication of Sigma Theta Tau International Honor Society of Nursing,['10.1111/jnu.12580']
2329,32536056,[Clinical study of yiqi huoxue recipe in the treatment of liver fibrosis of chronic viral hepatitis].,"Objective:  To clarify the clinical efficacy of Yiqi Huoxue recipe in the treatment of liver fibrosis of chronic viral hepatitis.  Methods:  An open, positive-drug, parallel-controlled study method was applied. A total of 207 cases of liver fibrosis with chronic hepatitis B and C diagnosed with liver biopsy and transient elastography were selected. According to the principle of syndrome differentiation in traditional Chinese medicine, self-made Yiqi Huoxue recipe ( n  = 127) and Fuzheng Huayu capsule ( n  = 80) were used for the treatment course of 24-48 weeks. Change score of TCM symptom, liver biochemistry, liver stiffness measurement (LSM), and noninvasive liver fibrosis index [aspartate transaminase to platelet ratio index (APRI), and fibrosis-4 score (FIB-4)] were compared between the two groups to evaluate the therapeutic effect of Yiqi Huoxue recipe on liver fibrosis.  Results:  Yiqi Huoxue recipe group and Fuzheng Huayu capsule group baseline LSM, APRI and FIB-4 was compared, and there was no statistically significant difference between them ( P  > 0.05). Yiqi Huoxue recipe and Fuzheng Huayu capsule received patients had improved symptom scores to a certain extent. Hepatic facies, discomfort over liver area, and soreness and weakness of waist and knees ( P  < 0.05) was significantly improved in Yiqi Huoxue recipe than Fuzheng Huayu capsule. Liver biochemical indicators (ALT, AST, GGT, ALP) had gradually relapsed with the extension of treatment duration and the normalization rate between the two groups after 24 to 48 weeks had reached 100% vs. 100%, 100% vs. 93.8%, 96.8% vs. 92.3% and 87.5% vs. 81.8%. After 12 weeks of treatment, APRI values ​​of both groups had significantly reduced, and after 48 weeks of treatment, LSM values of both groups had significantly improved. Moreover, Yiqi Huoxue recipe FIB-4 score was significantly improved after 48 weeks of treatment, and the difference was statistically significant compared to Fuzheng Huayu capsule group ( P  < 0.05). After treatment, LSM, APRI, and FIB-4 total effectiveness in the two groups were 80.0% vs. 63.6%,  P  = 0.046; 68.4% vs. 52.0%,  P  = 0.052; 68.4% vs. 62.0%,  P  = 0.437, respectively. LSM total effectiveness was significantly higher in Yiqi Huoxue recipe treated group than Fuzheng Huayu capsule group.  Conclusion:  Traditional Chinese medicine Yiqi Huoxue decoction can be used as an optimal treatment for liver fibrosis of chronic viral hepatitis.",2020,"Liver biochemical indicators (ALT, AST, GGT, ALP) had gradually relapsed with the extension of treatment duration and the normalization rate between the two groups after 24 to 48 weeks had reached 100% vs. 100%, 100% vs. 93.8%, 96.8% vs. 92.3% and 87.5% vs. 81.8%.","['liver fibrosis of chronic viral hepatitis', '207 cases of liver fibrosis with chronic hepatitis B and C diagnosed with liver biopsy and transient elastography were selected']","['yiqi huoxue recipe', 'Traditional Chinese medicine Yiqi Huoxue decoction', 'Fuzheng Huayu capsule', 'Yiqi Huoxue recipe']","['Hepatic facies, discomfort over liver area, and soreness and weakness of waist and knees', 'Change score of TCM symptom, liver biochemistry, liver stiffness measurement (LSM), and noninvasive liver fibrosis index [aspartate transaminase to platelet ratio index (APRI), and fibrosis-4 score (FIB-4', 'Yiqi Huoxue recipe FIB-4 score', 'LSM, APRI, and FIB-4 total effectiveness', 'normalization rate', 'liver fibrosis', 'APRI values', 'LSM values', 'LSM total effectiveness', 'symptom scores']","[{'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}, {'cui': 'C0276623', 'cui_str': 'Chronic viral hepatitis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0193388', 'cui_str': 'Biopsy of liver'}, {'cui': 'C2748260', 'cui_str': 'Transient elastography'}]","[{'cui': 'C0078696', 'cui_str': 'yiki-huoxue'}, {'cui': 'C0600194', 'cui_str': 'Recipes'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C2607355', 'cui_str': 'fuzheng huayu'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0078696', 'cui_str': 'yiki-huoxue'}, {'cui': 'C0600194', 'cui_str': 'Recipes'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",207.0,0.0372734,"Liver biochemical indicators (ALT, AST, GGT, ALP) had gradually relapsed with the extension of treatment duration and the normalization rate between the two groups after 24 to 48 weeks had reached 100% vs. 100%, 100% vs. 93.8%, 96.8% vs. 92.3% and 87.5% vs. 81.8%.","[{'ForeName': 'L Y', 'Initials': 'LY', 'LastName': 'Cui', 'Affiliation': 'Department of Traditional and Western Medical Hepatology, Third Hospital of Hebei Medical University, Hebei Key Laboratory of Mechanism of Liver Fibrosis in Chronic Liver Diseases, Shijiazhuang 050051, China.'}, {'ForeName': 'X X', 'Initials': 'XX', 'LastName': 'Zhang', 'Affiliation': 'Department of Traditional and Western Medical Hepatology, Third Hospital of Hebei Medical University, Hebei Key Laboratory of Mechanism of Liver Fibrosis in Chronic Liver Diseases, Shijiazhuang 050051, China.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Cui', 'Affiliation': 'Department of Traditional and Western Medical Hepatology, Third Hospital of Hebei Medical University, Hebei Key Laboratory of Mechanism of Liver Fibrosis in Chronic Liver Diseases, Shijiazhuang 050051, China.'}, {'ForeName': 'W C', 'Initials': 'WC', 'LastName': 'Li', 'Affiliation': 'Department of Traditional and Western Medical Hepatology, Third Hospital of Hebei Medical University, Hebei Key Laboratory of Mechanism of Liver Fibrosis in Chronic Liver Diseases, Shijiazhuang 050051, China.'}, {'ForeName': 'Y G', 'Initials': 'YG', 'LastName': 'Zhang', 'Affiliation': 'Department of Traditional and Western Medical Hepatology, Third Hospital of Hebei Medical University, Hebei Key Laboratory of Mechanism of Liver Fibrosis in Chronic Liver Diseases, Shijiazhuang 050051, China.'}, {'ForeName': 'R Q', 'Initials': 'RQ', 'LastName': 'Wang', 'Affiliation': 'Department of Traditional and Western Medical Hepatology, Third Hospital of Hebei Medical University, Hebei Key Laboratory of Mechanism of Liver Fibrosis in Chronic Liver Diseases, Shijiazhuang 050051, China.'}, {'ForeName': 'S X', 'Initials': 'SX', 'LastName': 'Zhao', 'Affiliation': 'Department of Traditional and Western Medical Hepatology, Third Hospital of Hebei Medical University, Hebei Key Laboratory of Mechanism of Liver Fibrosis in Chronic Liver Diseases, Shijiazhuang 050051, China.'}, {'ForeName': 'W G', 'Initials': 'WG', 'LastName': 'Ren', 'Affiliation': 'Department of Traditional and Western Medical Hepatology, Third Hospital of Hebei Medical University, Hebei Key Laboratory of Mechanism of Liver Fibrosis in Chronic Liver Diseases, Shijiazhuang 050051, China.'}, {'ForeName': 'L L', 'Initials': 'LL', 'LastName': 'Kong', 'Affiliation': 'Department of Traditional and Western Medical Hepatology, Third Hospital of Hebei Medical University, Hebei Key Laboratory of Mechanism of Liver Fibrosis in Chronic Liver Diseases, Shijiazhuang 050051, China.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Han', 'Affiliation': 'Department of Traditional and Western Medical Hepatology, Third Hospital of Hebei Medical University, Hebei Key Laboratory of Mechanism of Liver Fibrosis in Chronic Liver Diseases, Shijiazhuang 050051, China.'}, {'ForeName': 'X W', 'Initials': 'XW', 'LastName': 'Yuan', 'Affiliation': 'Department of Traditional and Western Medical Hepatology, Third Hospital of Hebei Medical University, Hebei Key Laboratory of Mechanism of Liver Fibrosis in Chronic Liver Diseases, Shijiazhuang 050051, China.'}, {'ForeName': 'L D', 'Initials': 'LD', 'LastName': 'Liu', 'Affiliation': 'Department of Traditional and Western Medical Hepatology, Third Hospital of Hebei Medical University, Hebei Key Laboratory of Mechanism of Liver Fibrosis in Chronic Liver Diseases, Shijiazhuang 050051, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Traditional and Western Medical Hepatology, Third Hospital of Hebei Medical University, Hebei Key Laboratory of Mechanism of Liver Fibrosis in Chronic Liver Diseases, Shijiazhuang 050051, China.'}, {'ForeName': 'Q S', 'Initials': 'QS', 'LastName': 'Zhang', 'Affiliation': 'Department of Traditional and Western Medical Hepatology, Third Hospital of Hebei Medical University, Hebei Key Laboratory of Mechanism of Liver Fibrosis in Chronic Liver Diseases, Shijiazhuang 050051, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Kong', 'Affiliation': 'Department of Traditional and Western Medical Hepatology, Third Hospital of Hebei Medical University, Hebei Key Laboratory of Mechanism of Liver Fibrosis in Chronic Liver Diseases, Shijiazhuang 050051, China.'}, {'ForeName': 'Y M', 'Initials': 'YM', 'LastName': 'Nan', 'Affiliation': 'Department of Traditional and Western Medical Hepatology, Third Hospital of Hebei Medical University, Hebei Key Laboratory of Mechanism of Liver Fibrosis in Chronic Liver Diseases, Shijiazhuang 050051, China.'}]",Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology,['10.3760/cma.j.cn501113-20190905-00325']
2330,32536106,"The effects of hand splinting in patients with early stage thumb carpometacarpal joint osteoarthritis: a randomized, controlled study.","BACKGROUND/AIM


The evidence for the effectiveness of splinting in the thumb carpometacarpal osteoarthritis is limited. We aimed to evaluate the effects of the pre-fabricated carpometacarpal metacarpophalangeal immobilization splint on pain, hand function, and hand strength in patients with early stage thumb carpometacarpal osteoarthritis.
MATERIALS AND METHODS


Sixty-three hands with stage 1 or 2 thumb carpometacarpal osteoarthritis were enrolled in the study. The non-splint group received an oral information about how to accommodate daily activities. In addition, the splint group was given a pre-fabricated carpometacarpal metacarpophalangeal immobilization splint for 6 weeks. Pain was evaluated using the Australian/Canadian Osteoarthritis Hand Index (AUSCAN). Hand functions were evaluated using the AUSCAN and the Quick Disabilities of Arm, Shoulder and Hand (Q-DASH) questionnaire. Grip and pinch strengths were measured using a hydraulic dynamometer and a hydraulic pinch gauge.
RESULTS


The AUSCAN pain, stiffness, function, total scores and the Q-DASH scores were significantly decreased in the splint group compared to the non-splint group. Significant increments in grip and pinch strengths were detected in the splint group compared to the non-splint group.
CONCLUSION


The pre-fabricated carpometacarpal metacarpophalangeal immobilization splint is effective in improving pain, hand function, and hand strength in the patients with thumb carpometacarpal osteoarthritis.",2020,"Significant increments in grip and pinch strengths were detected in the splint group compared to the non-splint group.
","['patients with early stage thumb carpometacarpal osteoarthritis', 'patients with early stage thumb carpometacarpal joint osteoarthritis', 'patients with thumb carpometacarpal osteoarthritis', 'Sixty-three hands with stage 1 or 2 thumb carpometacarpal osteoarthritis were enrolled in the study']","['carpometacarpal metacarpophalangeal immobilization splint', 'hand splinting', 'pre-fabricated carpometacarpal metacarpophalangeal immobilization splint']","['Pain', 'grip and pinch strengths', 'pain, hand function, and hand strength', 'AUSCAN pain, stiffness, function, total scores and the Q-DASH scores', 'Quick Disabilities of Arm, Shoulder and Hand (Q-DASH) questionnaire', 'Grip and pinch strengths']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0040067', 'cui_str': 'Thumb structure'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0224620', 'cui_str': 'Carpometacarpal joint structure'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0409162', 'cui_str': 'Splinting of hand'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C1720876', 'cui_str': 'Pinch Strength'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0242959', 'cui_str': 'Hand Strength'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0263746', 'cui_str': 'Degenerative joint disease of hand'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C1997924', 'cui_str': 'Disability of arm'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",63.0,0.02584,"Significant increments in grip and pinch strengths were detected in the splint group compared to the non-splint group.
","[{'ForeName': 'Asli', 'Initials': 'A', 'LastName': 'Can', 'Affiliation': ''}, {'ForeName': 'Nihal', 'Initials': 'N', 'LastName': 'Tezel', 'Affiliation': ''}]",Turkish journal of medical sciences,['10.3906/sag-1807-157']
2331,32536111,Hemodynamics in young athletes following high-intensity interval or moderate-intensity continuous training.,"BACKGROUND


The present study aimed to investigate the effects of HIIT versus moderate-intensity continuous training (MICT) on blood pressure (BP) and parameters of arterial stiffness in young athletes.
METHODS


17 rowers (aged 16±1.4 years) were randomized into an intervention group (IG) (n=10) and the control group (CG) (n=7). During an 8-week intervention period, the IG completed a HIIT on the rowing ergometer twice weekly (2x4x2 min at ≈95% of maximum heart rate (HRmax), 60-sec rest) in addition to the regular rowing training (3x/week MICT 70-90min, ≈70% HRmax). The CG completed the regular normal rowing training and, instead of the HIIT units, two additional MICT units (70-90min, ≈70% HRmax). Before and after the intervention period, hemodynamic parameters were recorded non-invasively in both groups.
RESULTS


After the intervention period, there was a significant decrease in peripheral systolic (p = 0.01) and diastolic (p =0.05) BP, as well as in central systolic (p = 0.05) and diastolic BP (p = 0.03) in the IG. Furthermore, pulse wave velocity (p = 0.05) was significantly reduced. Analysis of intervention effects revealed significant between-group differences in central diastolic BP (p = 0.05), in augmentation pressure (p = 0.02), and in augmentation index (p = 0.006) favoring IG. The CG showed no significant changes in the respected parameters throughout the intervention.
CONCLUSIONS


Already in adolescent athletes, a HIIT intervention has beneficial effects on peripheral and central BP as well as on pulse wave velocity, augmentation pressure, and augmentation index.",2020,"Analysis of intervention effects revealed significant between-group differences in central diastolic BP (p = 0.05), in augmentation pressure (p = 0.02), and in augmentation index (p = 0.006) favoring IG.","['young athletes', 'adolescent athletes', '17 rowers (aged 16±1.4 years', 'young athletes following high-intensity interval or moderate-intensity continuous training']","['control group (CG', 'HIIT intervention', 'HIIT versus moderate-intensity continuous training (MICT', 'regular rowing training']","['central diastolic BP', 'augmentation pressure', 'diastolic BP', 'central systolic', 'pulse wave velocity', 'diastolic', 'augmentation index', 'blood pressure (BP) and parameters of arterial stiffness', 'peripheral systolic', 'hemodynamic parameters']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}]",,0.0222633,"Analysis of intervention effects revealed significant between-group differences in central diastolic BP (p = 0.05), in augmentation pressure (p = 0.02), and in augmentation index (p = 0.006) favoring IG.","[{'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Ketelhut', 'Affiliation': 'Institute of Sports Science, Martin-Luther-University Halle-Wittenberg, Halle, Germany - sascha.ketelhut@gmail.com.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Kirchenberge', 'Affiliation': 'Medical Center Berlin, Berlin, Germany.'}, {'ForeName': 'Reinhard G', 'Initials': 'RG', 'LastName': 'Ketelhut', 'Affiliation': 'Medical Center Berlin, Berlin, Germany.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10814-4']
2332,32536118,The effect of extubation in prone position on emergence and recovery in lumbar spinal surgery.,"BACKGROUND


Extubation of patients in supine position after prone operations may lead to unwanted effects on hemodynamic and respiratory parameters during emergence and recovery period. We aimed to observe the effects of prone position on emergence and recovery periods after prone surgery.
METHODS


This randomised controlled trial was studied with sixty patients extubated either in prone position (30 patients) or in supine position (30 patients) after lumbar spinal surgery in tertiary educational hospitals. Heart rate, non-invasive arterial blood pressure, peripheral oxygen saturation and Bispectral Index values were measured, and recorded in all patients during operation, at the time anaesthetic agent was discontinued, before and after extubation. The number of the mouth suctioning, Aldrete recovery score, and Ricker agitation score were recorded together with the severity of cough during emergence and recovery. Incidents such as nausea, vomiting, respiratory failure, uncontrolled airway, and decreased saturation were also recorded.
RESULTS


Heart rate and mean arterial pressure values were significantly lower in the prone group during emergence and recovery period compared with the supine group (p<0.05). Aldrete Recovery Scores were higher in the prone group (p<0.001). The number of the mouth suctioning and the cough severity were lower in the prone group (p<0.001).
CONCLUSİONS


Extubation in the prone position provides a more comfortable emergence and recovery periods by less altering the hemodynamic and respiratory status with better recovery profile.",2020,"The number of the mouth suctioning and the cough severity were lower in the prone group (p<0.001).
","['lumbar spinal surgery', 'sixty patients extubated either in prone position (30 patients) or in supine position (30 patients) after lumbar spinal surgery in tertiary educational hospitals']",[],"['number of the mouth suctioning and the cough severity', 'Aldrete Recovery Scores', 'Heart rate, non-invasive arterial blood pressure, peripheral oxygen saturation and Bispectral Index values', 'number of the mouth suctioning, Aldrete recovery score, and Ricker agitation score', 'Heart rate and mean arterial pressure values', 'nausea, vomiting, respiratory failure, uncontrolled airway, and decreased saturation']","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C1272641', 'cui_str': 'Systemic arterial pressure'}, {'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}]",60.0,0.0615007,"The number of the mouth suctioning and the cough severity were lower in the prone group (p<0.001).
","[{'ForeName': 'Mesure G', 'Initials': 'MG', 'LastName': 'Ozden', 'Affiliation': 'Anesthesiology and Reanimation Clinic, Istanbul Medeniyet University Goztepe Education and Research Hospital, Istanbul, Turkey - nihanozdenn@gmail.com.'}, {'ForeName': 'Nurten', 'Initials': 'N', 'LastName': 'Bakan', 'Affiliation': 'Anesthesiology and Reanimation Clinic, Sancaktepe Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Kocoglu', 'Affiliation': 'Anesthesiology and Reanimation Clinic, Istanbul Medeniyet University Goztepe Education and Research Hospital, Istanbul, Turkey.'}]",Journal of neurosurgical sciences,['10.23736/S0390-5616.20.05007-9']
2333,32536123,[A multicenter randomized prospective study of concurrent chemoradiation with 60 Gy versus 50 Gy for inoperable esophageal squamous cell carcinoma].,"Objective:  To determine whether 60 Gy is superior to standard 50 Gy for definitive concurrent chemoradiation(CCRT) in esophageal squamous cell carcinoma (ESCC) using modern radiation technology in a phase Ⅲ prospective randomized trial.  Methods:  From April 2013 to May 2017, 331 patients from 22 hospitals who were pathologically confirmed with stage ⅢA-ⅣA ESCC were randomized to 60 Gy or 50 Gy with random number table. Total of 305 patients were analyzed, including 152 in 60 Gy group and 153 in 50 Gy group. The median age was 63 years, 242(79.3%) males and 63(20.7%) females. The median length of primary tumor was 5.6 cm. The clinical characteristics between two groups were comparable. All patients were delivered 2 Gy per fraction, 5 fractions per week. Concurrent weekly chemotherapy with docetaxel (25 mg/m(2)) and cisplatin (25 mg/m(2)) and 2 cycles consolidation chemotherapy with docetaxel (70 mg/m(2)) and cisplatin (25 mg/m(2), d1-3) were administrated. The primary endpoint was local/regional progression-free survival (LRPFS). The data were compared with Pearson chi-square test or Fisher's exact test.  Results:  At a median follow-up of 27.3 months, the disease progression rate was 37.5% (57/152), 43.8% (67/153) in the high and standard-dose group, respectively (χ(2)=1.251,  P= 0.263). The 1, 2, 3-year LRPFS rate was 75.4%, 56.8%, 52.1% and 74.2%, 58.4%, 50.1%, respectively ( HR : 0.95, 95 %CI : 0.69-1.31,  P= 0.761). The 1, 2, 3-year overall survival rate was 84.1%, 64.8%, 54.1% and 85.4%, 62.9%, 54.0%, respectively ( HR : 0.98, 95 %CI : 0.71-1.38,  P= 0.927). The 1, 2, 3-year progression-free survival rate was 70.8%, 54.2%, 48.5% and 65.5%, 51.9%, 45.1%, respectively ( HR : 0.93, 95 %CI : 0.68-1.26,  P= 0.621). The incidence rates in toxicities between the two groups were similar except for higher rate of severe pneumonitis in high dose group (χ(2)=11.596,  P= 0.021).  Conclusions:  The efficacy in disease control is similar between 60 Gy and 50 Gy using modern radiation technology concurrent with chemotherapy for ESCC. The 50 Gy should be recommended as the regular radiation dose with CCRT for ESCC.",2020,The efficacy in disease control is similar between 60 Gy and 50 Gy using modern radiation technology concurrent with chemotherapy for ESCC.,"['Total of 305 patients were analyzed, including 152 in 60 Gy group and 153 in 50 Gy group', 'Methods:  From April 2013 to May 2017, 331 patients from 22 hospitals who were pathologically confirmed with stage ⅢA-ⅣA ESCC', 'esophageal squamous cell carcinoma (ESCC', 'inoperable esophageal squamous cell carcinoma', 'The median age was 63 years, 242(79.3%) males and 63(20.7%) females']","['cisplatin (25 mg/m(2)) and 2 cycles consolidation chemotherapy with docetaxel', 'concurrent chemoradiation with 60 Gy versus 50 Gy', 'chemotherapy with docetaxel', 'cisplatin', 'standard 50 Gy for definitive concurrent chemoradiation(CCRT']","['incidence rates in toxicities', '3-year overall survival rate', 'local/regional progression-free survival (LRPFS', 'median length of primary tumor', 'disease progression rate', 'severe pneumonitis', '3-year LRPFS rate', '3-year progression-free survival rate']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517703', 'cui_str': '305'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C3179017', 'cui_str': 'Consolidation Chemotherapy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3714636', 'cui_str': 'Pneumonitis'}]",305.0,0.101413,The efficacy in disease control is similar between 60 Gy and 50 Gy using modern radiation technology concurrent with chemotherapy for ESCC.,"[{'ForeName': 'Y J', 'Initials': 'YJ', 'LastName': 'Xu', 'Affiliation': 'Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, the Department of Thoracic Radiation Oncology, Cancer Hospital of University of Chinese Academy of Sciences; Zhejiang Cancer Hospital, Hangzhou 310022, China.'}, {'ForeName': 'W G', 'Initials': 'WG', 'LastName': 'Zhu', 'Affiliation': ""the Department of Radiation Oncology, Huai'an First People's Hospital, Huai'an 223300, China.""}, {'ForeName': 'Z X', 'Initials': 'ZX', 'LastName': 'Liao', 'Affiliation': 'the Department of Radiation Oncology, University of Taxes, M.D. Anderson Cancer Center, Houston 77030, the United States.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Kong', 'Affiliation': 'Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, the Department of Thoracic Radiation Oncology, Cancer Hospital of University of Chinese Academy of Sciences; Zhejiang Cancer Hospital, Hangzhou 310022, China.'}, {'ForeName': 'W W', 'Initials': 'WW', 'LastName': 'Wang', 'Affiliation': ""the Department of Radiation Oncology, Huai'an First People's Hospital, Huai'an 223300, China.""}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Li', 'Affiliation': 'the Department of Thoracic Radiation Oncology, Fujian Cancer Hospital, Fuzhou 350014, China.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Huang', 'Affiliation': ""the Department of Radiation Oncology, Foshan First People's Hospital, Foshan 528000, China.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'He', 'Affiliation': ""the Department of Radiation Oncology, Foshan First People's Hospital, Foshan 528000, China.""}, {'ForeName': 'X M', 'Initials': 'XM', 'LastName': 'Yang', 'Affiliation': ""the Department of Medical Oncology, Jiaxing First People's Hospital, Jiaxing 314000, China.""}, {'ForeName': 'L P', 'Initials': 'LP', 'LastName': 'Liu', 'Affiliation': ""the Department of Oncology, Jining First People's Hospital, Jining 272011, China.""}, {'ForeName': 'Z W', 'Initials': 'ZW', 'LastName': 'Sun', 'Affiliation': ""the Department of Oncology, Jining First People's Hospital, Jining 272011, China.""}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'He', 'Affiliation': ""the Department of Radiation Oncology, Quzhou People's Hospital, Quzhou 324000, China.""}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Bao', 'Affiliation': 'the Department of Radiation Oncology, Affiliated Cancer Hospital, Sun Yat-Sen University, Guangzhou 510080, China(is working in the First Affiliated Hospital of Sun Yat-Sen University).'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zeng', 'Affiliation': ""the Department of Radiation Oncology, Sichuan Provincial People's Hospital, Chengdu 610072, China.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Pu', 'Affiliation': ""the Department of Radiation Oncology, Lianshui People's Hospital, Lianshui 223400, China.""}, {'ForeName': 'W Y', 'Initials': 'WY', 'LastName': 'Hu', 'Affiliation': 'the Department of Radiation Oncology, Jinhua Central Hospital, Jinhua 321000, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'the Department of Radiation Oncology, Anhui Provincial Hospital, Hefei 230001, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'the Department of Radiation Oncology, Affiliated Hospital of Bengbu Medical College, Bengbu 233004, China.'}, {'ForeName': 'Z G', 'Initials': 'ZG', 'LastName': 'Liu', 'Affiliation': 'the Department of Radiation Oncology, Hunan Cancer Hospital, Changsha 410013, China(is working in the Fifth Affiliated Hospital of Sun Yat-Sen University now).'}, {'ForeName': 'T T', 'Initials': 'TT', 'LastName': 'Zhuang', 'Affiliation': 'the Department of Radiation Oncology, Affiliated Cancer Hospital of Shantou University Medical College, Shantou 515031, China.'}, {'ForeName': 'B X', 'Initials': 'BX', 'LastName': 'Tan', 'Affiliation': 'the Department of Radiation Oncology, Affiliated Hospital of North Sichuan Medical College, Nanchong 637000, China.'}, {'ForeName': 'X H', 'Initials': 'XH', 'LastName': 'Du', 'Affiliation': 'Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, the Department of Thoracic Radiation Oncology, Cancer Hospital of University of Chinese Academy of Sciences; Zhejiang Cancer Hospital, Hangzhou 310022, China.'}, {'ForeName': 'G Q', 'Initials': 'GQ', 'LastName': 'Qiu', 'Affiliation': 'Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, the Department of Thoracic Radiation Oncology, Cancer Hospital of University of Chinese Academy of Sciences; Zhejiang Cancer Hospital, Hangzhou 310022, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, the Department of Thoracic Radiation Oncology, Cancer Hospital of University of Chinese Academy of Sciences; Zhejiang Cancer Hospital, Hangzhou 310022, China.'}, {'ForeName': 'Y L', 'Initials': 'YL', 'LastName': 'Ji', 'Affiliation': 'Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, the Department of Thoracic Radiation Oncology, Cancer Hospital of University of Chinese Academy of Sciences; Zhejiang Cancer Hospital, Hangzhou 310022, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, the Department of Thoracic Radiation Oncology, Cancer Hospital of University of Chinese Academy of Sciences; Zhejiang Cancer Hospital, Hangzhou 310022, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, the Department of Thoracic Radiation Oncology, Cancer Hospital of University of Chinese Academy of Sciences; Zhejiang Cancer Hospital, Hangzhou 310022, China.'}, {'ForeName': 'H L', 'Initials': 'HL', 'LastName': 'Ma', 'Affiliation': 'Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, the Department of Thoracic Radiation Oncology, Cancer Hospital of University of Chinese Academy of Sciences; Zhejiang Cancer Hospital, Hangzhou 310022, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, the Department of Thoracic Radiation Oncology, Cancer Hospital of University of Chinese Academy of Sciences; Zhejiang Cancer Hospital, Hangzhou 310022, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': ""the Department of Radiation Oncology, Changzhou First People's Hospital, Changzhou 213003, China.""}, {'ForeName': 'A W', 'Initials': 'AW', 'LastName': 'Liu', 'Affiliation': 'the Department of Radiation Oncology, Second Affiliated Hospital of Nanchang University, Nanchang 330006, China.'}, {'ForeName': 'X D', 'Initials': 'XD', 'LastName': 'Liang', 'Affiliation': ""the Department of Radiation Oncology, Zhejiang People's Hospital, Hangzhou 310014, China.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tao', 'Affiliation': 'the Department of Radiation Oncology, Jiangsu Cancer Hospital, Nanjing 210009, China.'}, {'ForeName': 'J Y', 'Initials': 'JY', 'LastName': 'Zhou', 'Affiliation': 'the Department of Radiation Oncology, First Affiliated Hospital of Suzhou University, Suzhou 215006, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'the Department of Radiation Oncology, Affiliated Cancer Hospital of Guangzhou Medical University, Guangzhou 510095, China.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, the Department of Thoracic Radiation Oncology, Cancer Hospital of University of Chinese Academy of Sciences; Zhejiang Cancer Hospital, Hangzhou 310022, China.'}]",Zhonghua yi xue za zhi,['10.3760/cma.j.cn112137-20200303-00574']
2334,32536177,Effect of N-acetylcysteine against Vancomycin-Induced Nephrotoxicity: A Randomized Controlled Clinical Trial.,"BACKGROUND


The proposed mechanism of vancomycin-induced nephrotoxicity (VIN) is indirect production of reactive oxygen species in the kidney tissue. This study aimed to investigate the effectiveness of N-acetylcysteine (NAC), an anti-oxidant agent, in the prevention of VIN.
METHODS


Patients who received vancomycin for any indication were randomly divided to drug (NAC) and control groups. The patients in the drug group received oral NAC 600 mg every 12 hours for 10 days, starting concurrently with vancomycin. Serum creatinine (SCr) levels and blood urea nitrogen (BUN) as well as creatinine clearance (CrCl) and 12-hour urine volume were recorded at baseline, every other day during the study, and 12 hours after the last dose of vancomycin on the 10th day. Furthermore, the cases of acute kidney injury (AKI; ≥ 0.5 mg/dL or at least 50% increase in serum creatinine from baseline) were recorded in the two groups.
RESULTS


Over the study period, 84 and 95 patients completed the study in drug and control groups, respectively. SCr and CrCl were significantly lower and higher, respectively, at all-time points (except for baseline) in the NAC compared to the control group. Furthermore, although not statistically significant, 12 cases of vancomycin-induced AKI were observed in the control group (12.63%), while 4 cases (4.76%) were reported from drug group (P = 0.066; relative risk [RR] = 0.377, 95% CI: 0.126-1.124).
CONCLUSION


NAC has the potential for reduction of VIN. However, more studies are necessary to confirm this effect.",2020,"SCr and CrCl were significantly lower and higher, respectively, at all-time points (except for baseline) in the NAC compared to the control group.","['84 and 95 patients completed the study in drug and control groups, respectively', 'Patients who received']","['N-acetylcysteine (NAC', 'vancomycin', 'N-acetylcysteine against Vancomycin-Induced Nephrotoxicity', 'oral NAC', 'drug (NAC', 'NAC', 'vancomycin-induced nephrotoxicity (VIN']","['Serum creatinine (SCr) levels and blood urea nitrogen (BUN) as well as creatinine clearance (CrCl) and 12-hour urine volume', 'serum creatinine', 'SCr and CrCl', 'vancomycin-induced AKI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0595916', 'cui_str': 'Toxic nephropathy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}]",,0.0396664,"SCr and CrCl were significantly lower and higher, respectively, at all-time points (except for baseline) in the NAC compared to the control group.","[{'ForeName': 'Shirinsadat', 'Initials': 'S', 'LastName': 'Badri', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Rasool', 'Initials': 'R', 'LastName': 'Soltani', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Sayadi', 'Affiliation': 'Students Research Committee, Faculty of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Farzin', 'Initials': 'F', 'LastName': 'Khorvash', 'Affiliation': 'Department of Infectious Diseases, Faculty of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Meidani', 'Affiliation': 'Department of Infectious Diseases, Faculty of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Taheri', 'Affiliation': 'Isfahan Kidney Diseases Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Archives of Iranian medicine,['10.34172/aim.2020.33']
2335,32536195,Canakinumab after Electrical Cardioversion in Patients with Persistent Atrial Fibrillation: A Pilot Randomized Trial.,,2020,,['Patients with Persistent Atrial Fibrillation'],['Canakinumab after Electrical Cardioversion'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}]","[{'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}]",[],,0.0404341,,"[{'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Krisai', 'Affiliation': 'Department of Cardiology & Cardiovascular Research Institute Basel, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Blum', 'Affiliation': 'Department of Cardiology & Cardiovascular Research Institute Basel, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Renate B', 'Initials': 'RB', 'LastName': 'Schnabel', 'Affiliation': 'Department of General and Interventional Cardiology, University Heart and Vascular Center Hamburg (UHZ), Hamburg & German Center for Cardiovascular Research (DZHK), partner site Hamburg/Kiel/Luebeck, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sticherling', 'Affiliation': 'Department of Cardiology & Cardiovascular Research Institute Basel, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kühne', 'Affiliation': 'Department of Cardiology & Cardiovascular Research Institute Basel, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'von Felten', 'Affiliation': 'Clinical Trial Unit, Department of Clinical Research, University of Basel, Basel & Department of Biostatistics, Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ammann', 'Affiliation': 'Department of Cardiology, Kantonsspital St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Pruvot', 'Affiliation': 'Department of Cardiology, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Albert', 'Affiliation': 'Department of Cardiology, Smidt Heart Institute, Cedars Sinai Medical Center, Los Angeles, CA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Conen', 'Affiliation': 'Cardiovascular Research Institute Basel, University Hospital Basel, Basel, Switzerland & Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Canada.'}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.119.008197']
2336,32536213,Condom Use and Error Experience Among Young Adolescents: Implications for Classroom Instruction.,"We examine condom failure and use error experienced by high school youth in two regions of the United States. Data are from a baseline survey of a randomized controlled trial to evaluate FLASH, a sexual health education curriculum for high school students. Participants were 1,597 ninth- or 10th-grade students in health class who had parental consent and who assented to participate in the study. This study examines condom use behavior among students who reported vaginal or anal sex at baseline. Of the 222 participants who reported having vaginal or anal sex in the 3 months prior to baseline survey, 180 of them reported using a condom at least once. Of these youth, 70.6% reported that they did not squeeze the tip of the condom before sex, 25.0% of youth reported that they did not roll the condom all the way down to the base of the penis, and 49.4% reported that they did not hold the base of the penis when pulling out; 36.9% reported experiencing condom breakage or slippage. The frequency of condom error and/or failure reported by young adolescents in this study indicates a need for further education on potential condom use errors with an emphasis on the correct steps for using a condom to prevent condom failure. High rates of error and failure suggest an opportunity for educators to tailor preexisting condom use interventions to further reinforce the skills necessary for effective condom use and to educate on what to do in the event of condom failure.",2020,High rates of error and failure suggest an opportunity for educators to tailor preexisting condom use interventions to further reinforce the skills necessary for effective condom use and to educate on what to do in the event of condom failure.,"['Young Adolescents', 'high school students', 'students who reported vaginal or anal sex at baseline', 'Participants were 1,597 ninth- or 10th-grade students in health class who had parental consent and who assented to participate in the study', 'high school youth in two regions of the United States', '222 participants who reported having vaginal or anal sex in the 3 months prior to baseline survey, 180 of them reported using a condom at least once']",['FLASH'],['Condom Use and Error Experience'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0282347', 'cui_str': 'Anal sex'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205443', 'cui_str': 'Ninth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0600634', 'cui_str': 'Parental Consent'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0420877', 'cui_str': 'Uses contraceptive sheath'}, {'cui': 'C0585347', 'cui_str': 'Single event'}]","[{'cui': 'C0085635', 'cui_str': 'Photopsia'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",1597.0,0.0575757,High rates of error and failure suggest an opportunity for educators to tailor preexisting condom use interventions to further reinforce the skills necessary for effective condom use and to educate on what to do in the event of condom failure.,"[{'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Barrett', 'Affiliation': 'ETR, Scotts Valley, CA, USA.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Laris', 'Affiliation': 'ETR, Scotts Valley, CA, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Anderson', 'Affiliation': 'ETR, Scotts Valley, CA, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Baumler', 'Affiliation': 'University of Texas, Galveston, TX, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Gerber', 'Affiliation': 'Public Health-Seattle & King County in Seattle, WA, USA.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Kesler', 'Affiliation': 'Public Health-Seattle & King County in Seattle, WA, USA.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Coyle', 'Affiliation': 'ETR, Scotts Valley, CA, USA.'}]",Health promotion practice,['10.1177/1524839920935431']
2337,32536270,"No efficacy of transcranial direct current stimulation on chronic migraine with medication overuse: A double blind, randomised clinical trial.","BACKGROUND


Transcranial direct current stimulation was suggested to provide beneficial effects in chronic migraine, a condition often associated with medication overuse for which no long-term therapy is available.
METHODS


We conducted a randomised controlled trial to assess long-term efficacy of transcranial direct current stimulation. Adults diagnosed with chronic migraine and medication overuse were assigned to receive in a 1:1:1 ratio anodal, cathodal, or sham transcranial direct current stimulation daily for five consecutive days, along with standardised drug withdrawal protocol. Primary outcome was 50% reduction of days of headache per month at 12 months. Co-secondary outcomes were 50% reduction of days of headache per month at 6 months, reduction of analgesic intake per month, and change in disability and quality of life, catastrophising, depression, state and trait anxiety, dependence attitude and allodynia intensity. Patients were not allowed to take any migraine prophylaxis drug for the entire study period.
RESULTS


We randomly allocated 135 patients to anodal (44), cathodal (45), and sham (46) transcranial direct current stimulation. At 6 and 12 months, the percentage of reduction of days of headache and number of analgesics per month ranged between 48.5% and 64.7%, without differences between transcranial direct current stimulation (cathodal, anodal, or the results obtained from the two arms of treatment, anodal plus cathodal) and sham. Catastrophising attitude significantly reduced at 12 months in all groups. There was no difference for the other secondary outcomes.
CONCLUSIONS


Transcranial direct current stimulation did not influence the short and long-term course of chronic migraine with medication overuse after acute drug withdrawal. Behavioral and educational measures and support for patients' pain management could provide long-term improvement and low relapse rate.  Trial  registration number NCT04228809.",2020,Catastrophising attitude significantly reduced at 12 months in all groups.,"['Adults diagnosed with chronic migraine and medication overuse', 'chronic migraine with medication overuse']","['anodal (44), cathodal (45), and sham (46) transcranial direct current stimulation', 'transcranial direct current stimulation', 'ratio anodal, cathodal, or sham transcranial direct current stimulation daily']","['Catastrophising attitude', 'reduction of days of headache', 'analgesic intake per month, and change in disability and quality of life, catastrophising, depression, state and trait anxiety, dependence attitude and allodynia intensity', 'percentage of reduction of days of headache and number of analgesics']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C3266697', 'cui_str': 'Medication overuse'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0458247', 'cui_str': 'Allodynia'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",135.0,0.342995,Catastrophising attitude significantly reduced at 12 months in all groups.,"[{'ForeName': 'Licia', 'Initials': 'L', 'LastName': 'Grazzi', 'Affiliation': 'Neuroalgology Unit, Headache Centre, Fondazione IRCCS Istituto Neurologico ""Carlo Besta"", Milan, Italy.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Usai', 'Affiliation': 'Neuroalgology Unit, Headache Centre, Fondazione IRCCS Istituto Neurologico ""Carlo Besta"", Milan, Italy.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Bolognini', 'Affiliation': 'Department of Psychology and Milan Center for Neuroscience, University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Grignani', 'Affiliation': 'Neuroalgology Unit, Headache Centre, Fondazione IRCCS Istituto Neurologico ""Carlo Besta"", Milan, Italy.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Sansone', 'Affiliation': 'Neuroalgology Unit, Headache Centre, Fondazione IRCCS Istituto Neurologico ""Carlo Besta"", Milan, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Tramacere', 'Affiliation': 'Department of Research and Clinical Development, Scientific Directorate, Fondazione IRCCS Istituto Neurologico ""Carlo Besta"", Milan, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Maravita', 'Affiliation': 'Department of Psychology and Milan Center for Neuroscience, University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Lauria', 'Affiliation': 'Neuroalgology Unit, Headache Centre, Fondazione IRCCS Istituto Neurologico ""Carlo Besta"", Milan, Italy.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102420931050']
2338,32536286,A novel femoral artery compression device (butterfly compress) versus manual compression for hemostasis after femoral artery puncture: a randomized comparison.,"Objective:  This study aimed to investigate the hemostatic efficacy of a novel femoral artery compression device in patients undergoing an interventional procedure through femoral artery puncture. Material and methods:  Patients enrolled in this trial were randomly assigned 1:1 to the novel femoral artery compression device (NFACD) or the manual compression (MC) group. The primary endpoints were time to hemostasis (TTH), time to ambulation (TTA), any other complications, such as the occurrence of hematoma, bleeding, pseudoaneurysm and arteriovenous fistula at the puncture site, and time to hospital discharge. Results:  A total of 617 patients were included in this study (NFACD,  n  = 308 versus MC,  n  = 309) from May 2017 to September 2019, and the baseline characteristics of the groups were similar. We found that the TTH and TTA were significantly shorter in the NFACD group than in the MC group (4.4 ± 11.6 min vs. 20.1 ± 22.5 min;  p  < 0.001; 8.9 ± 14.2 h vs. 16.3 ± 27.5 h;  p  = 0.002). There were few other complications in either group. In addition, there was no significant difference in time to hospital discharge between the NFACD group and the MC group. Conclusion:  The novel femoral artery compression device is effective in achieving hemostasis in patients undergoing femoral artery puncture and is associated with a marked shortening of the TTH and TTA.",2020,We found that the TTH and TTA were significantly shorter in the NFACD group than in the MC group (4.4 ± 11.6 min vs. 20.1 ± 22.5 min;  p  < 0.001; 8.9 ± 14.2 h vs. 16.3 ± 27.5 h;  p  = 0.002).,"['A total of 617 patients were included in this study (NFACD,  n \u2009=\u2009308 versus MC,  n \u2009=\u2009309) from May 2017 to September 2019, and the baseline characteristics of the groups were similar', 'hemostasis after femoral artery puncture', 'patients undergoing an interventional procedure through femoral artery puncture', 'patients undergoing femoral artery puncture']","['novel femoral artery compression device (butterfly compress) versus manual compression', 'novel femoral artery compression device (NFACD) or the manual compression (MC', 'novel femoral artery compression device', 'NFACD']","['time to hemostasis (TTH), time to ambulation (TTA), any other complications, such as the occurrence of hematoma, bleeding, pseudoaneurysm and arteriovenous fistula at the puncture site, and time to hospital discharge', 'hemostatic efficacy', 'time to hospital discharge', 'TTH and TTA']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0006496', 'cui_str': 'Butterfly'}, {'cui': 'C0332260', 'cui_str': 'Compressing'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1510412', 'cui_str': 'Pseudoaneurysm'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1627773', 'cui_str': 'Tissue texture abnormality'}]",617.0,0.173141,We found that the TTH and TTA were significantly shorter in the NFACD group than in the MC group (4.4 ± 11.6 min vs. 20.1 ± 22.5 min;  p  < 0.001; 8.9 ± 14.2 h vs. 16.3 ± 27.5 h;  p  = 0.002).,"[{'ForeName': 'He', 'Initials': 'H', 'LastName': 'Yi', 'Affiliation': 'Department of Vascular Surgery, The Fifth Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Guo', 'Initials': 'G', 'LastName': 'Peng', 'Affiliation': 'Department of Vascular Surgery, The Fifth Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Niu', 'Initials': 'N', 'LastName': 'Xiao Yang', 'Affiliation': 'Department of Vascular Surgery, The Fifth Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Bing', 'Affiliation': 'Department of Vascular Surgery, The Fifth Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Yue', 'Affiliation': 'Department of Vascular Surgery, The Fifth Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Ying', 'Affiliation': 'Department of Vascular Surgery, The Fifth Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Wu', 'Initials': 'W', 'LastName': 'Fei', 'Affiliation': 'Department of Vascular Surgery, The Fifth Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}]",Minimally invasive therapy & allied technologies : MITAT : official journal of the Society for Minimally Invasive Therapy,['10.1080/13645706.2020.1773856']
2339,32536289,"Lower Extremity Open Skill Training Effects on Perception of Visual Stimuli, Cognitive Processing, and Performance.","This study investigates if lower extremity open-skill training impacts perception and cognitive processing abilities or just influences task related motor abilities. Twenty-two participants (24.7 ± 2.4years; 11 males, 11 females) were randomly allocated either into the group that trained on a computerized device or to the control group. Prior to and following the 4-week study period, motor performance was assessed using drop jump, hexagon test, postural control and lower extremity choice reaction. Perception, cognitive processing and task inhibition were captured using validated neurocognitive tests. Repeated measurements analyses of co-variances (ANCOVAs) were performed. They revealed a time (before and after intervention) × group (training vs. control) effect on lower extremity choice reaction and hexagon ( p  < .05). No effects on group differences or between groups in cognitive performance were found. A detrimental effect of training on accuracy of task inhibition (lower percentage of correct inhibitions) was detected. Computerized open skill training affects specific movement patterns without increasing task-relevant cognitive or perceptual abilities. Indicated by the lower percentage of correct inhibitions, the training might further detrimentally influence the risk-taking behavior during choice reaction tasks.",2020,× group (training vs. control) effect on lower extremity choice reaction and hexagon ( p  < .05).,"['Twenty-two participants (24.7\u2009±\u20092.4years; 11 males, 11 females']",['Computerized open skill training'],"['cognitive performance', 'accuracy of task inhibition', 'lower extremity choice reaction and hexagon', 'Perception, cognitive processing and task inhibition', 'Perception of Visual Stimuli, Cognitive Processing, and Performance']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]",22.0,0.0145631,× group (training vs. control) effect on lower extremity choice reaction and hexagon ( p  < .05).,"[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Engeroff', 'Affiliation': 'Preventive and Sports Medicine, Institute of Occupational, Social and Environmental Medicine, Hospital of the Goethe-University Frankfurt am Main, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Giesche', 'Affiliation': 'Preventive and Sports Medicine, Institute of Occupational, Social and Environmental Medicine, Hospital of the Goethe-University Frankfurt am Main, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Friebe', 'Affiliation': 'Preventive and Sports Medicine, Institute of Occupational, Social and Environmental Medicine, Hospital of the Goethe-University Frankfurt am Main, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Wilke', 'Affiliation': 'Department of Sports Medicine and Exercise Physiology, Goethe University Frankfurt am Main, Frankfurt, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Vogt', 'Affiliation': 'Department of Sports Medicine and Exercise Physiology, Goethe University Frankfurt am Main, Frankfurt, Germany.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Banzer', 'Affiliation': 'Preventive and Sports Medicine, Institute of Occupational, Social and Environmental Medicine, Hospital of the Goethe-University Frankfurt am Main, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Niederer', 'Affiliation': 'Department of Sports Medicine and Exercise Physiology, Goethe University Frankfurt am Main, Frankfurt, Germany.'}]",Journal of motor behavior,['10.1080/00222895.2020.1776674']
2340,32536316,Clinical comparison of single-incision and dual-incision approaches for the treatment of distal tibial and fibular fractures: A randomized controlled trial.,"PURPOSE


The purpose of this study was to clinically compare the single-incision and dual-incision approaches for the treatment of distal tibial and fibular fractures.
METHODS


In total, 93 patients were enrolled, and the mean follow-up was 15 months (range 12-19 months). The patients treated for open reduction and internal fixation were randomly classified into two groups based on the approach used: 45 patients were treated using the single-incision approach (group 1) and 48 patients were treated using the dual-incision approach (group 2). In these two groups, operation time, discharge time, postoperative complications, and ankle function evaluations (Olerud-Molander Ankle Score) were compared between the two groups.
RESULTS


There were no significant differences in the mean operation time (98.2 ± 18.5 vs. 103.6 ± 19.3), discharge time (11.1 ± 3.9 vs. 12.5 ± 5.7), overall surgical complication rates (9/45 vs. 15/48), or ankle function between the two groups ( p  > 0.05). However, the rate of soft tissue-related complications, such as skin slough, infection, nonunion, and delayed union, was significantly lower in group 1 (5/45) than in group 2 (14/48) ( p  < 0.05).
CONCLUSION


The two incision approaches were found to have similar clinical outcomes. However, with regard to soft tissue conservation, the single-incision approach was superior to the dual-incision and maybe a reliable alternative.",2020,"However, with regard to soft tissue conservation, the single-incision approach was superior to the dual-incision and maybe a reliable alternative.","['distal tibial and fibular fractures', '93 patients were enrolled, and the mean follow-up was 15 months (range 12-19 months', 'patients treated for open reduction and internal fixation']","['dual-incision approach', 'single-incision approach', 'single-incision and dual-incision approaches']","['discharge time', 'ankle function', 'operation time, discharge time, postoperative complications, and ankle function evaluations (Olerud-Molander Ankle Score', 'rate of soft tissue-related complications, such as skin slough, infection, nonunion, and delayed union', 'overall surgical complication rates', 'mean operation time']","[{'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0159852', 'cui_str': 'Fracture of tibia AND fibula'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0185373', 'cui_str': 'Open reduction of fracture'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0027544', 'cui_str': 'Necrotic debris'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",93.0,0.0259224,"However, with regard to soft tissue conservation, the single-incision approach was superior to the dual-incision and maybe a reliable alternative.","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'An', 'Affiliation': ""Department of Traumatic Orthopedics, Ningbo No. 6 Hospital, Ningbo, Zhejiang, People's Republic of China.""}, {'ForeName': 'Jingwei', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Traumatic Orthopedics, Ningbo No. 6 Hospital, Ningbo, Zhejiang, People's Republic of China.""}, {'ForeName': 'Weihu', 'Initials': 'W', 'LastName': 'Ma', 'Affiliation': ""Department of Traumatic Orthopedics, Ningbo No. 6 Hospital, Ningbo, Zhejiang, People's Republic of China.""}, {'ForeName': 'Limei', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': ""Department of Traumatic Orthopedics, Ningbo No. 6 Hospital, Ningbo, Zhejiang, People's Republic of China.""}, {'ForeName': 'Xianfeng', 'Initials': 'X', 'LastName': 'He', 'Affiliation': ""Department of Traumatic Orthopedics, Ningbo No. 6 Hospital, Ningbo, Zhejiang, People's Republic of China.""}, {'ForeName': 'Jichong', 'Initials': 'J', 'LastName': 'Ying', 'Affiliation': ""Department of Traumatic Orthopedics, Ningbo No. 6 Hospital, Ningbo, Zhejiang, People's Republic of China.""}, {'ForeName': 'Yunqiang', 'Initials': 'Y', 'LastName': 'Zhuang', 'Affiliation': ""Department of Traumatic Orthopedics, Ningbo No. 6 Hospital, Ningbo, Zhejiang, People's Republic of China.""}, {'ForeName': 'Yunqiang', 'Initials': 'Y', 'LastName': 'Zhuang', 'Affiliation': ""Department of Traumatic Orthopedics, Ningbo No. 6 Hospital, Ningbo, Zhejiang, People's Republic of China.""}, {'ForeName': 'Tianming', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': ""Department of Traumatic Orthopedics, Ningbo No. 6 Hospital, Ningbo, Zhejiang, People's Republic of China.""}]",Journal of orthopaedic surgery (Hong Kong),['10.1177/2309499020930305']
2341,32536320,"Feasibility, Acceptability, and Clinical Implementation of an Immersive Virtual Reality Intervention to Address Psychological Well-Being in Children and Adolescents With Cancer.","Objective:  Virtual reality (VR), a novel and highly immersive technology, offers promise in addressing potential psychological impacts of cancer treatments and hospitalization. The primary aim of this study was to examine multiple key user perspectives on the acceptability and feasibility of an Immersive VR therapeutic intervention for use with hospitalized patients with cancer. Secondary aims were to identify issues and opportunities related to the adoption and clinical implementation of VR in pediatric oncology settings.  Method:  The study was conducted at The Royal Children's Hospital (RCH), Melbourne, Australia. Thirty multidisciplinary oncology health care professionals participated in an initial test of VR intervention usability (Stage 1). Ninety oncology inpatients (7-19 years) and their parent caregivers participated in a pilot randomized controlled study to examine the effectiveness of an Immersive VR therapeutic intervention (Stage 2). This mixed methods study reports Stages 1 and 2 quantitative and qualitative data related to VR feasibility and acceptability.  Results:  Results indicate favorable perceptions from health care professionals with respect to ease of use and usefulness of VR, and had positive intentions to use it in the future. Parent caregivers reported high acceptability of VR for their hospitalized child. Patients reported high satisfaction of the VR intervention within minimal adverse effects. Barriers and facilitators to VR use with seriously ill children and specific recommendations for content development were elicited.  Conclusion:  This study shows that there are several potential clinical uses for Immersive VR intervention, beyond medical procedural distraction, to support psychological adjustment to hospitalization and patient quality of life.",2020,The primary aim of this study was to examine multiple key user perspectives on the acceptability and feasibility of an Immersive VR therapeutic intervention for use with hospitalized patients with cancer.,"['Ninety oncology inpatients (7-19 years) and their parent caregivers participated', 'Children and Adolescents With Cancer', 'Thirty multidisciplinary oncology health care professionals participated in an initial test of VR intervention usability (Stage 1', 'hospitalized patients with cancer', ""Royal Children's Hospital (RCH), Melbourne, Australia""]","['Immersive VR therapeutic intervention (Stage 2', 'Immersive VR therapeutic intervention', 'Immersive Virtual Reality Intervention', 'Virtual reality (VR), a novel and highly immersive technology']",[],"[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]",[],90.0,0.0155384,The primary aim of this study was to examine multiple key user perspectives on the acceptability and feasibility of an Immersive VR therapeutic intervention for use with hospitalized patients with cancer.,"[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Tennant', 'Affiliation': 'Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'McGillivray', 'Affiliation': 'Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'George J', 'Initials': 'GJ', 'LastName': 'Youssef', 'Affiliation': 'Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'McCarthy', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Tara-Jane', 'Initials': 'TJ', 'LastName': 'Clark', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}]",Journal of pediatric oncology nursing : official journal of the Association of Pediatric Oncology Nurses,['10.1177/1043454220917859']
2342,32536331,A clinical method of evaluating simple reaction time and reaction accuracy is sensitive to a single dose of lorazepam.,"RATIONALE


Benzodiazepines are useful and commonly prescribed. Unfortunately, they are associated with subtle but functionally significant neurocognitive side effects that increase the risk of motor vehicle accidents and falls.
OBJECTIVE


The objective of this study was to determine whether clinically feasible measures of simple reaction time and reaction accuracy are sensitive to a single dose of lorazepam.
METHODS


Using a randomized, double-blind, crossover design, 26 healthy adults (13 women; age = 26.9 ± 8.2 yr) were given 1.0 mg lorazepam or placebo 90 minutes prior to two data collection sessions. Participants completed simple and reaction accuracy tasks using a standardized ""ruler drop"" testing paradigm during each session. Outcomes were mean and variability of simple reaction time and reaction accuracy, which evaluates a participant's ability to catch the device solely on the random 50% of trials that lights affixed to it illuminate on release. Reaction accuracy requires a go/no-go decision within 420 ms before the falling device strikes the floor.
RESULTS


As compared with placebo, lorazepam increased simple reaction time variability (range = 43 ± 18 vs. 60 ± 23 ms, respectively;  p  = 0.004 and standard deviation = 14.6 ± 5.7 vs. 19.7 ± 7.3 ms, respectively; = 0.006) and decreased reaction accuracy (90 ± 7% vs. 84 ± 11%, respectively;  p  = 0.010).
CONCLUSION


Given prior work demonstrating associations between simple reaction time and reaction accuracy and functional outcomes such as self-protection, response to perturbations, and fall risk, these clinically available measures may have a role in identifying subtle, functionally significant cognitive changes related to short-term benzodiazepine use.",2020,"RESULTS


As compared with placebo, lorazepam increased simple reaction time variability (range = 43 ± 18 vs. 60 ± 23 ms, respectively;  p  = 0.004 and standard deviation = 14.6 ± 5.7 vs. 19.7 ± 7.3 ms, respectively; = 0.006) and decreased reaction accuracy (90 ± 7% vs. 84 ± 11%, respectively;  p  = 0.010).
",['26 healthy adults (13 women; age = 26.9 ± 8.2\u2009yr'],"['lorazepam', 'lorazepam or placebo', 'placebo, lorazepam']","['mean and variability of simple reaction time and reaction accuracy', 'simple reaction time variability', 'simple reaction time and reaction accuracy and functional outcomes such as self-protection, response to perturbations, and fall risk', 'reaction accuracy']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0024002', 'cui_str': 'Lorazepam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}]",26.0,0.207435,"RESULTS


As compared with placebo, lorazepam increased simple reaction time variability (range = 43 ± 18 vs. 60 ± 23 ms, respectively;  p  = 0.004 and standard deviation = 14.6 ± 5.7 vs. 19.7 ± 7.3 ms, respectively; = 0.006) and decreased reaction accuracy (90 ± 7% vs. 84 ± 11%, respectively;  p  = 0.010).
","[{'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Richardson', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Michigan, Ann Arbor, USA.'}, {'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'Eckner', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Michigan, Ann Arbor, USA.'}, {'ForeName': 'Hogene', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Mechanical Engineering, University of Michigan, Ann Arbor, USA.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Ashton-Miller', 'Affiliation': 'Department of Mechanical Engineering, University of Michigan, Ann Arbor, USA.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120915409']
2343,32536335,Effects of Quiet Mind Training on Alpha Power Suppression and Fine Motor Skill Acquisition.,"The aim of the present study was to investigate the effect of Quiet Mind Training (QMT) on Alpha power suppression and fine motor skill acquisition among novice dart players. 30 novice dart players were randomly assigned either to a QMT or a control condition. Playing skills and Alpha power suppression were assessed at four time-points: at baseline, retention test 1, under pressure conditions, at retention test 2. Over time, Alpha power suppression increased and radial errors decreased but more so in the QMT condition than in the control condition. In contrast to the control condition, darts performance and Alpha power suppression in the QMT condition were also stable under pressure conditions. Results indicated that QMT successfully suppressed Alpha power and improved implicit learning skills.",2020,"Over time, Alpha power suppression increased and radial errors decreased but more so in the QMT condition than in the control condition.","['30 novice dart players', 'novice dart players']","['QMT', 'Quiet Mind Training (QMT', 'Quiet Mind Training', 'QMT or a control condition']","['Alpha power suppression and fine motor skill acquisition', 'Alpha power and improved implicit learning skills', 'radial errors', 'Alpha Power Suppression and Fine Motor Skill Acquisition', 'Playing skills and Alpha power suppression']","[{'cui': 'C0336707', 'cui_str': 'Dart'}]","[{'cui': 'C0439654', 'cui_str': 'Quiet'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0032214', 'cui_str': 'Play'}]",,0.023571,"Over time, Alpha power suppression increased and radial errors decreased but more so in the QMT condition than in the control condition.","[{'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Norouzi', 'Affiliation': 'Faculty of Sport Science, Department of Motor Behavior, Urmia University, Urmia, Iran.'}, {'ForeName': 'Fatemeh Sadat', 'Initials': 'FS', 'LastName': 'Hosseini', 'Affiliation': 'Faculty of Sport Science, Department of Motor Behavior, Urmia University, Urmia, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Vaezmosavi', 'Affiliation': 'Faculty of Social Science, Department of Physical Education, Imam Hossein University, Tehran, Iran.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Gerber', 'Affiliation': 'Department of Sport, Exercise and Health, Division of Sport and Psychosocial Health, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Pühse', 'Affiliation': 'Department of Sport, Exercise and Health, Division of Sport and Health Pedagogy, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Brand', 'Affiliation': 'Department of Sport, Exercise and Health, Division of Sport and Psychosocial Health, University of Basel, Basel, Switzerland.'}]",Journal of motor behavior,['10.1080/00222895.2020.1777930']
2344,32536366,A randomized controlled study of weighted chain blankets for insomnia in psychiatric disorders.,"STUDY OBJECTIVES


This study aimed to evaluate the effect of weighted chain blankets on insomnia and sleep-related daytime symptoms for patients with major depressive disorder, bipolar disorder, generalized anxiety disorder (GAD) and attention deficit hyperactivity disorder (ADHD).
METHODS


One hundred twenty patients were randomized (1:1) to either a weighted metal chain blanket or a light plastic chain blanket for four weeks. The outcome was evaluated using the Insomnia Severity Index (ISI) as primary outcome measure and the Day and Night Diaries (DND), Fatigue Symptom Inventory (FSI), and Hospital Anxiety and Depression Scale (HADS) as secondary outcome measures. Sleep and daytime activity levels were evaluated by wrist actigraphy.
RESULTS


At four weeks, there was a significant advantage in ISI-ratings of the weighted blanket intervention over the light blanket (p<0.001) with a large effect size (Cohen´s d 1.90). The intervention by the weighted blanket resulted in a significantly better sleep-maintenance, a higher daytime activity level and reduced daytime symptoms of fatigue, depression and anxiety. No serious adverse events occurred. During a 12 months open follow up phase of the study, participants continuing using weighted blankets maintained the effect on sleep, while patients switching from a light to a weighted blanket got a similar effect on ISI-ratings as participants using the weighted blanket from the beginning.
CONCLUSIONS


We conclude that weighted chain blankets are an effective and safe intervention for insomnia in patients with Major depressive disorder, Bipolar disorder, Generalized Anxiety Disorder, or ADHD, also improving daytime symptoms and levels of activity.",2020,"At four weeks, there was a significant advantage in ISI-ratings of the weighted blanket intervention over the light blanket (p<0.001) with a large effect size (Cohen´s d 1.90).","['insomnia in psychiatric disorders', 'patients with major depressive disorder, bipolar disorder, generalized anxiety disorder (GAD) and attention deficit hyperactivity disorder (ADHD', 'One hundred twenty patients']","['weighted chain blankets', 'weighted metal chain blanket or a light plastic chain blanket']","['sleep-maintenance', 'daytime activity level and reduced daytime symptoms of fatigue, depression and anxiety', 'Sleep and daytime activity levels', 'Insomnia Severity Index (ISI) as primary outcome measure and the Day and Night Diaries (DND), Fatigue Symptom Inventory (FSI), and Hospital Anxiety and Depression Scale (HADS', 'insomnia and sleep-related daytime symptoms', 'ISI-ratings']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0179330', 'cui_str': 'Blanket'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0032167', 'cui_str': 'Plastic'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",120.0,0.0823028,"At four weeks, there was a significant advantage in ISI-ratings of the weighted blanket intervention over the light blanket (p<0.001) with a large effect size (Cohen´s d 1.90).","[{'ForeName': 'Bodil', 'Initials': 'B', 'LastName': 'Ekholm', 'Affiliation': 'The Affective Disorder Outpatient Clinic at Psychiatry Southwest, Karolinska University Hospital Huddinge, Stockholm, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Spulber', 'Affiliation': 'Department of Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Adler', 'Affiliation': 'The Affective Disorder Outpatient Clinic at Psychiatry Southwest, Karolinska University Hospital Huddinge, Stockholm, Sweden.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8636']
2345,32536425,[The effect of thoracic paravertebral block on seroma reduction in breast surgery - a randomized controlled trial].,"BACKGROUND


Increasing number of patients are being operated because of breast cancer. Seroma is the most common problem that occurs after surgery that increases morbidity. For postoperative pain management, Thoracic Paravertebral Block (TPVB) has long been considered the gold standard technique. With performing TPVB, sympathetic nerves are also blocked.
OBJECTIVE


With this study, we aimed to search the effect of TPVB on seroma reduction in patients who undergo mastectomy and axillary node dissection surgery.
METHODS


Forty ASA I-II female patients aged 18-65, who were scheduled to go under elective unilateral mastectomy and axillary lymph node resection were included to the study. Patients were randomized into two groups as TPVB and control group. Ultrasound guided TPVB with 20 mL 0.25% bupivacaine was performed at T1 level preoperatively to the TPVB group patients. All patients were provided with i.v. patient-controlled analgesia device. Seroma formation amounts, morphine consumptions and Numeric Rating Scale (NRS) scores for pain were recorded 24 th  hour postoperatively.
RESULTS AND CONCLUSIONS


Mean seroma formation at postoperative 24 th  hour was 112.5±53.3 mL in the control group and 74.5±47.4 mL in the TPVB group (p=0.022). NRS scores were similar between two groups (p=0.367) at postoperative 24 th  hour but mean morphine consumption at postoperative 24 th  hour was 5.6±4 mg in the TPBV group, and 16.6±6.9 mg in the control group (p <0.001). TPVB reduces the amount of seroma formation while providing effective analgesia in patients who undergo mastectomy and axillary lymph node removal surgery.",2020,"NRS scores were similar between two groups (p=0.367) at postoperative 24 th  hour but mean morphine consumption at postoperative 24 th  hour was 5.6±4 mg in the TPBV group, and 16.6±6.9 mg in the control group (p <0.001).","['patients who undergo mastectomy and axillary lymph node removal surgery', 'patients who undergo mastectomy and axillary node dissection surgery', 'Forty ASA I-II female patients aged 18-65, who were scheduled to go under elective unilateral mastectomy and axillary lymph node resection were included to the study']","['thoracic paravertebral block', 'Ultrasound guided TPVB with 20 mL 0.25% bupivacaine', 'Thoracic Paravertebral Block (TPVB', 'TPVB']","['seroma reduction', 'Seroma formation amounts, morphine consumptions and Numeric Rating Scale (NRS) scores for pain', 'seroma formation', 'morbidity', 'Mean seroma formation', 'NRS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0729594', 'cui_str': 'Axillary lymph node group'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0024886', 'cui_str': 'Simple mastectomy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",40.0,0.0698048,"NRS scores were similar between two groups (p=0.367) at postoperative 24 th  hour but mean morphine consumption at postoperative 24 th  hour was 5.6±4 mg in the TPBV group, and 16.6±6.9 mg in the control group (p <0.001).","[{'ForeName': 'Alparslan', 'Initials': 'A', 'LastName': 'Kuş', 'Affiliation': 'Kocaeli University Hospital, Department of Anesthesiology and Reanimation, Kocaeli, Turquia.'}, {'ForeName': 'Ufuk H', 'Initials': 'UH', 'LastName': 'Yörükoğlu', 'Affiliation': 'Kocaeli University Hospital, Department of Anesthesiology and Reanimation, Kocaeli, Turquia. Electronic address: ufukyorukoglu@gmail.com.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Aksu', 'Affiliation': 'Kocaeli University Hospital, Department of Anesthesiology and Reanimation, Kocaeli, Turquia.'}, {'ForeName': 'Saffet', 'Initials': 'S', 'LastName': 'Çınar', 'Affiliation': 'Kocaeli University Hospital, Department of General Surgery, Kocaeli, Turquia.'}, {'ForeName': 'Nuh Zafer', 'Initials': 'NZ', 'LastName': 'Cantürk', 'Affiliation': 'Kocaeli University Hospital, Department of General Surgery, Kocaeli, Turquia.'}, {'ForeName': 'Yavuz', 'Initials': 'Y', 'LastName': 'Gürkan', 'Affiliation': 'Kocaeli University Hospital, Department of Anesthesiology and Reanimation, Kocaeli, Turquia.'}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2019.12.015']
2346,32536440,Effect of Mozart K.448 on interictal epileptiform discharges in children with epilepsy: A randomized controlled pilot study.,"BACKGROUND


Epilepsy is a common pediatric neurologic disease in Thailand. However, the mainstay antiepileptic pharmacotherapies can induce severe side effects. While the benefit of playing Mozart K.448 music has been studied as an alternative, supplementary, nonpharmacologic treatment for epilepsy, the literature features limited few randomized controlled trial studies of children.
OBJECTIVE


We aimed to study the effect of Mozart K.448 for two pianos on interictal epileptiform discharges (IEDs), quantitative electroencephalogram (qEEG), and heart rate variability (HRV) in patients with epilepsy.
METHODS


We employed a single-blinded randomized trial design with a placebo control. The treatment group listened to the first 8 min of Mozart K.448 for two pianos during EEG recording. The control group underwent an EEG recording of the same duration in a quiet environment. Interictal epileptiform discharges were manually counted for 8 min before, during, and after the song was plated. Quantitative electroencephalogram and HRV were analyzed in each period.
RESULT


A total of 32 patients aged 0-18 years were enrolled. There were 12 patients in the music group and 14 patients in the control group; 67% of the patients in the former exhibited significantly decreased IEDs while listening to the music compared with 42% of the patients in the quiet group (RR [Relative Risk Reduction]: 0.72, p-value: <0.001, 95% confidence interval [CI]: 0.69-0.74). During music exposure, qEEG demonstrated an increase in the delta/theta to alpha/beta ratio relative to that of controls (median in music: +3% and control: -6%, p-value: 0.520). Heart rate variability analyses showed a decrease in the ratio of low frequency to high frequency (LF/HF), which represents parasympathetic activity during music exposure (decrease of 34%, p-value: 0.382).
CONCLUSION


The present study showed that Mozart K.448 reduced the number of IEDs in children with epilepsy and that Mozart K.448 could enhance parasympathetic activity. However, possibly because of the small study population, statistical significance was not reached. Our study revealed the considerable potential of music in the treatment of pediatric epilepsy.",2020,"Heart rate variability analyses showed a decrease in the ratio of low frequency to high frequency (LF/HF), which represents parasympathetic activity during music exposure (decrease of 34%, p-value: 0.382).
","['pediatric epilepsy', 'patients with epilepsy', '32 patients aged 0-18\u202fyears were enrolled', 'children with epilepsy']","['placebo', 'Mozart K.448']","['interictal epileptiform discharges', 'number of IEDs', 'Quantitative electroencephalogram and HRV', 'parasympathetic activity during music exposure', 'interictal epileptiform discharges (IEDs), quantitative electroencephalogram (qEEG), and heart rate variability (HRV', 'severe side effects', 'parasympathetic activity', 'Interictal epileptiform discharges', 'delta/theta to alpha/beta ratio relative', 'IEDs while listening to the music']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}]",32.0,0.224274,"Heart rate variability analyses showed a decrease in the ratio of low frequency to high frequency (LF/HF), which represents parasympathetic activity during music exposure (decrease of 34%, p-value: 0.382).
","[{'ForeName': 'Tanitnun', 'Initials': 'T', 'LastName': 'Paprad', 'Affiliation': 'Division of Pediatric Neurology, Department of Pediatrics, King Chulalongkorn Memorial Hospital/Thai Red Cross Society, Thailand.'}, {'ForeName': 'Montida', 'Initials': 'M', 'LastName': 'Veeravigrom', 'Affiliation': 'Division of Pediatric Neurology, Department of Pediatrics, King Chulalongkorn Memorial Hospital/Thai Red Cross Society, Thailand; Division of Pediatric Neurology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Thailand. Electronic address: montida.v@chula.ac.th.'}, {'ForeName': 'Tayard', 'Initials': 'T', 'LastName': 'Desudchit', 'Affiliation': 'Division of Pediatric Neurology, Department of Pediatrics, King Chulalongkorn Memorial Hospital/Thai Red Cross Society, Thailand; Division of Pediatric Neurology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Thailand.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107177']
2347,32536496,External Cardiac Massage Training of Medical Students: A Randomized Comparison of Two Feedback Methods to Standard Training.,"BACKGROUND


The most recent recommendations support learning of external cardiac massage (ECM) through feedback devices.
OBJECTIVES


The objective was to compare the effects on immediate and 3-month retention of ECM technical skills when using feedback devices compared with training without feedback as part of a half-day training session in medical students.
METHODS


This randomized study was performed using the Resusci Anne QCPR manikin in 64 medical students. We compared the quality of ECM with nonfeedback training in the control group (group 1) vs. 2 feedback learning methods (group 2, PocketCPR and group 3, Skill Reporter each used with visual display available to the trainee). At the end of the training session and 3 months later, students performed chest compressions blindly during a 2-min assessment session. The median compression score was the primary outcome for assessing immediate and long-term retention.
RESULTS


Regarding immediate retention, the median compression score was significantly lower in group 1 (23%) than in groups 2 (81%) and 3 (72%) (p < 0.05) with no difference between the 2 feedback methods. At 3 months, mean compression scores remained high but not significantly different between the 2 feedback groups.
CONCLUSION


The use of a feedback device used for ECM training improves the quality of immediate retention of technical ECM skills compared with traditional teaching in medical students. At 3 months, the 2 groups with feedback retained a high level of performance. No significant difference could be demonstrated between the 2 feedback methods.",2020,The use of a feedback device used for ECM training improves the quality of immediate retention of technical ECM skills compared with traditional teaching in medical students.,"['Medical Students', 'medical students', '64 medical students']","['external cardiac massage (ECM', 'External Cardiac Massage Training', 'ECM with nonfeedback training', 'feedback learning methods (group 2, PocketCPR and group 3, Skill Reporter each used with visual display available to the trainee', 'ECM training']","['mean compression scores', 'median compression score', 'quality of immediate retention of technical ECM skills']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C0009039', 'cui_str': 'Manual external cardiac massage with closed chest'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0335038', 'cui_str': 'Reporter'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0009039', 'cui_str': 'Manual external cardiac massage with closed chest'}]",,0.0523229,The use of a feedback device used for ECM training improves the quality of immediate retention of technical ECM skills compared with traditional teaching in medical students.,"[{'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Suet', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, Hôpital Bicêtre, Le Kremlin Bicêtre, France; Paris Sud Medical School, Paris Sud University, Le Kremlin Bicêtre, France.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Blanie', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, Hôpital Bicêtre, Le Kremlin Bicêtre, France; Paris Sud Medical School, Paris Sud University, Le Kremlin Bicêtre, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'de Montblanc', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, Hôpital Bicêtre, Le Kremlin Bicêtre, France; Paris Sud Medical School, Paris Sud University, Le Kremlin Bicêtre, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Roulleau', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, Hôpital Bicêtre, Le Kremlin Bicêtre, France; Paris Sud Medical School, Paris Sud University, Le Kremlin Bicêtre, France.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Benhamou', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, Hôpital Bicêtre, Le Kremlin Bicêtre, France; Paris Sud Medical School, Paris Sud University, Le Kremlin Bicêtre, France.'}]",The Journal of emergency medicine,['10.1016/j.jemermed.2020.04.058']
2348,32536501,Postoperative pain after tonsillectomy - the value of standardized analgesic treatment protocols.,"OBJECTIVE


To alleviate pain after tonsillectomy (TE) with escalating gradual treatment protocols in a prospective trial.
MATERIALS & METHODS


Following TE, 83 consecutive adult patients were treated with two different four-staged escalating analgesic protocols. Metamizole served as basic medication in protocol 1 (PT1; n = 44), whereas with protocol 2 (PT2; n = 39) ibuprofen was applied as baseline analgesic. Both protocols were escalated according to the patient´s needs to metamizole and ibuprofen vice versa and additional weak to strong opioids. The primary efficacy endpoint was defined as the minimum and maximum pain as well as pain on ambulation (NRS, 0-10). Secondary endpoints comprised analgesic score, patient satisfaction and treatment-related side-effects.
RESULTS


Both patient groups exhibited similar demographic characteristics (PT1: Ø 28.8 years; 64% ♀ and PT2: Ø 26.6 years; 56% ♀). Maximum pain (6.7 ± 1.9 vs. 7.6 ± 1.6, t (81)  = -2.254, p = 0.027) and pain on ambulation (5.0 ± 1.8 vs. 5.8 ± 1.8, t (81)  = -2.114, p = 0.038) were significantly higher with PT2. 68.2% of patients with PT1 needed an escalation of analgesic treatment compared to 100% with PT2 (p < 0.001). The opioid consumption was also significantly higher with PT2 (43.2% vs. 71.8%, p < 0.001). There were no significant differences regarding functional impairments, side-effects and patient satisfaction (7.0 ± 2.0 vs. 7.4 ± 2.4, t (79)  = -0.897, p = 0.373).
CONCLUSION


Both treatment protocols yielded in a high degree of patient satisfaction but dissatisfactory pain relief following TE. Metamizole can be recommended as a basic medication allowing for improved pain relief. Reported pain intensities were independent of the amount of opioid intake. Further research is mandatory to standardize and improve analgesic treatment after TE.",2020,"The opioid consumption was also significantly higher with PT2 (43.2% vs. 71.8%, p < 0.001).","['Following TE, 83 consecutive adult patients were treated with two different four-staged escalating analgesic protocols']","['PT2', 'Metamizole', 'ibuprofen', 'tonsillectomy (TE']","['pain intensities', 'functional impairments, side-effects and patient satisfaction', 'pain relief', 'analgesic score, patient satisfaction and treatment-related side-effects', 'minimum and maximum pain as well as pain on ambulation (NRS, 0-10', 'pain on ambulation', 'opioid consumption', 'Postoperative pain', 'Maximum pain']","[{'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0012586', 'cui_str': 'Dipyrone'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",83.0,0.0645109,"The opioid consumption was also significantly higher with PT2 (43.2% vs. 71.8%, p < 0.001).","[{'ForeName': 'Antoniu-Oreste', 'Initials': 'AO', 'LastName': 'Gostian', 'Affiliation': 'Department of ENT, Head and Neck Surgery, University of Erlangen-Nuremberg, Waldstrasse 1, 91054 Erlangen, Erlangen, Germany. Electronic address: antoniu-oreste.gostian@uk-erlangen.de.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Loeser', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Tholen', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Medical Faculty, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Wolber', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Medical Faculty, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Otte', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Medical Faculty, University of Cologne, Cologne, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schwarz', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Medical Faculty, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Ludwig Maximilian', 'Initials': 'LM', 'LastName': 'Heindl', 'Affiliation': 'Department of Ophthalmology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Balk', 'Affiliation': 'Department of ENT, Head and Neck Surgery, University of Erlangen-Nuremberg, Waldstrasse 1, 91054 Erlangen, Erlangen, Germany.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Gostian', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Hospital of Cologne, Cologne, Germany.'}]","Auris, nasus, larynx",['10.1016/j.anl.2020.05.011']
2349,32536527,Arthroscopic Remnant-Preserving Anterior Talofibular Ligament Reconstruction does not Improve Mid-term Function in Chronic Ankle Instability.,"BACKGROUND


Anterior talofibular ligament (ATFL) reconstruction is routinely undertaken to manage chronic lateral ankle instability (CLAI). This study evaluated the effects on clinical outcome of preserving or not preserving the ATFL remnant when reconstructing the ATFL.
METHODS


From January 2015 to July 2017, 53 CLAI patients with ATFL injury were randomized to undergo either a remnant-preserving (preservation of ATFL) or a non-preserving (no preservation of ATFL) anatomic reconstruction of the ATFL using an ipsilateral free semitendinosus tendon autograft. The Visual Analogue Scale (VAS) score, the American Orthopedic Foot and Ankle Society (AOFAS) score, Karlsson Ankle Functional Score (KAFS), Anterior Talar Translation (ATT), and ankle proprioceptive recovery in both groups were compared.
RESULTS


All patients were followed up for at least 2 years, VAS, AOFAS, KAFS, ATT and ankle proprioception between two the groups were not statistically significant different.
CONCLUSION


There are no differences at 2.5 years in postoperative ankle function, stability and proprioceptive recovery when an ipsilateral free semitendinosus tendon autograft is used to manage CLAI regardless of preservation of the remnant ATFL.",2020,"There are no differences at 2.5 years in postoperative ankle function, stability and proprioceptive recovery when an ipsilateral free semitendinosus tendon autograft is used to manage CLAI regardless of preservation of the remnant ATFL.","['From January 2015 to July 2017, 53 CLAI patients with ATFL injury']","['Arthroscopic Remnant-Preserving Anterior Talofibular Ligament Reconstruction', 'Anterior talofibular ligament (ATFL) reconstruction', 'remnant-preserving (preservation of ATFL) or a non-preserving (no preservation of ATFL) anatomic reconstruction of the ATFL using an ipsilateral free semitendinosus tendon autograft']","['Visual Analogue Scale (VAS) score, the American Orthopedic Foot and Ankle Society (AOFAS) score, Karlsson Ankle Functional Score (KAFS), Anterior Talar Translation (ATT), and ankle proprioceptive recovery', 'postoperative ankle function, stability and proprioceptive recovery', 'VAS, AOFAS, KAFS, ATT and ankle proprioception']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0277851', 'cui_str': 'Ankle instability'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0225166', 'cui_str': 'Structure of anterior talofibular ligament'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]","[{'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0225166', 'cui_str': 'Structure of anterior talofibular ligament'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0921292', 'cui_str': 'Tendon of semitendinosus'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}]",,0.0344146,"There are no differences at 2.5 years in postoperative ankle function, stability and proprioceptive recovery when an ipsilateral free semitendinosus tendon autograft is used to manage CLAI regardless of preservation of the remnant ATFL.","[{'ForeName': 'Shi-Ming', 'Initials': 'SM', 'LastName': 'Feng', 'Affiliation': 'Hand and Foot Microsurgery Department, Xuzhou Central Hospital, Xuzhou Clinical College of Xuzhou Medical University, Xuzhou, Jiangsu, 221009, PR China; Xuzhou Clinical College of Xuzhou Medical University, Xuzhou, Jiangsu, 221009, PR China.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Maffulli', 'Affiliation': 'Department of Musculoskeletal Disorders, Faculty of Medicine and Surgery, University of Salerno, Salerno, Italy; Centre for Sports and Exercise Medicine, Barts and The London School of Medicine and Dentistry, Mile End Hospital, 275 Bancroft Road, London, E1 4DG, England. Electronic address: n.maffulli@qmul.ac.uk.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Oliva', 'Affiliation': 'Department of Musculoskeletal Disorders, Faculty of Medicine and Surgery, University of Salerno, Salerno, Italy.'}, {'ForeName': 'Ai-Guo', 'Initials': 'AG', 'LastName': 'Wang', 'Affiliation': 'Hand and Foot Microsurgery Department, Xuzhou Central Hospital, Xuzhou Clinical College of Xuzhou Medical University, Xuzhou, Jiangsu, 221009, PR China.'}, {'ForeName': 'Qing-Qing', 'Initials': 'QQ', 'LastName': 'Sun', 'Affiliation': 'Xuzhou Clinical College of Xuzhou Medical University, Xuzhou, Jiangsu, 221009, PR China.'}]",Injury,['10.1016/j.injury.2020.05.011']
2350,32532346,Efficacy and mechanisms of a single-session behavioral medicine class among patients with chronic pain taking prescription opioids: study protocol for a randomized controlled trial.,"BACKGROUND


Independent of pain intensity, pain-specific distress is highly predictive of pain treatment needs, including the need for prescription opioids. Given the inherently distressing nature of chronic pain, there is a need to equip individuals with pain education and self-regulatory skills that are shown to improve adaptation and improve their response to medical treatments. Brief, targeted behavioral medicine interventions may efficiently address the key individual factors, improve self-regulation in the context of pain, and reduce the need for opioid therapy. This highlights the critical need for targeted, cost-effective interventions that efficiently address the key psychological factors that can amplify the need for opioids and increased risk for misuse. In this trial, the primary goal is to test the comparative efficacy of a single-session skills-based pain management class to a health education active control group among patients with chronic pain who are taking opioids.
METHODS/DESIGN


Our study is a randomized, double-blind clinical trial testing the superiority of our 2-h, single-session skills-based pain management class against a 2-h health education class. We will enroll 136 adult patients with mixed-etiology chronic pain who are taking opioid prescription medication and randomize 1:1 to one of the two treatment arms. We hypothesize superiority for the skills-based pain class for pain control, self-regulation of pain-specific distress, and reduced opioid use measured by daily morphine equivalent. Team researchers masked to treatment assignment will assess outcomes up to 12 months post treatment.
DISCUSSION


This study aims to test the utility of a single-session, 2-h skills-based pain management class to improve self-regulation of pain and reduce opioid use. Findings from our project have the potential to shift current research and clinical paradigms by testing a brief and scalable intervention that could reduce the need for opioids and prevent misuse effectively, efficiently, and economically. Further, elucidation of the mechanisms of opioid use can facilitate refinement of more targeted future treatments.
TRIAL REGISTRATION


ClinicalTrials.gov, ID: NCT03950791. Registered on 10 May 2019.",2020,"We hypothesize superiority for the skills-based pain class for pain control, self-regulation of pain-specific distress, and reduced opioid use measured by daily morphine equivalent.","['136 adult patients with mixed-etiology chronic pain who are taking opioid prescription medication and randomize 1:1 to one of the two treatment arms', 'patients with chronic pain who are taking opioids', 'patients with chronic pain taking prescription opioids']","['single-session skills-based pain management class', 'single-session, 2-h skills-based pain management class', 'single-session behavioral medicine class']",[],"[{'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0004937', 'cui_str': 'Medicine, Behavioral'}]",[],136.0,0.161062,"We hypothesize superiority for the skills-based pain class for pain control, self-regulation of pain-specific distress, and reduced opioid use measured by daily morphine equivalent.","[{'ForeName': 'Maisa S', 'Initials': 'MS', 'LastName': 'Ziadni', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford University, 1070 Arastradero Road, Suite 200, Palo Alto, CA, 94304, USA. mziadni@stanford.edu.'}, {'ForeName': 'Abby L', 'Initials': 'AL', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford University, 1070 Arastradero Road, Suite 200, Palo Alto, CA, 94304, USA.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Winslow', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford University, 1070 Arastradero Road, Suite 200, Palo Alto, CA, 94304, USA.'}, {'ForeName': 'Sean C', 'Initials': 'SC', 'LastName': 'Mackey', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford University, 1070 Arastradero Road, Suite 200, Palo Alto, CA, 94304, USA.'}, {'ForeName': 'Beth D', 'Initials': 'BD', 'LastName': 'Darnall', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford University, 1070 Arastradero Road, Suite 200, Palo Alto, CA, 94304, USA.'}]",Trials,['10.1186/s13063-020-04415-x']
2351,32532354,Autism Spectrum Social Stories In Schools Trial 2 (ASSSIST2): study protocol for a randomised controlled trial analysing clinical and cost-effectiveness of Social Stories™ in primary schools.,"BACKGROUND


Interventions designed to support children with a diagnosis of Autism Spectrum Conditions (ASC) can be time consuming, needing involvement of outside experts. Social Stories™ are a highly personalised intervention aiming to give children with ASC social information or describing an otherwise difficult situation or skill. This can be delivered daily by staff in education settings. Studies examining Social Story™ use have yielded mostly positive results but have largely been single case studies with a lack of randomised controlled trials (RCTs). Despite this numerous schools are utilising Social Stories™, and a fully powered RCT is timely.
METHODS


A multi-site pragmatic cluster RCT comparing care as usual with Social Stories™ and care as usual. This study will recruit 278 participants (aged 4-11) with a clinical diagnosis of ASC, currently attending primary school in the North of England. Approximately 278 school based staff will be recruited to provide school based information about participating children with approximately 140 recruited to deliver the intervention. The study will be cluster randomised by school. Potential participants will be screened for eligibility prior to giving informed consent. Follow up data will be collected at 6 weeks and 6 months post randomisation and will assess changes in participants' social responsiveness, goal based outcomes, social and emotional health. The primary outcome measure is the Social Responsiveness Scale Second Edition (SRS-2) completed by school based staff at 6 months. Approvals have been obtained from the University of York's Research Governance Committee, Research Ethics Committee and the Health Research Authority. Study results will be submitted for publication in peer-reviewed journals and disseminated to participating families, educational staff, local authority representatives, community groups and Patient and Participant Involvement representatives. Suggestions will be made to NICE about treatment evidence dependent on findings.
DISCUSSION


This study addresses a much used but currently under researched intervention and results will inform school based support for primary school children with a diagnosis of ASC.
TRIAL REGISTRATION


The trial is registered on the ISRCTN registry (registration number: ISRCTN11634810). The trial was retrospectively registered on 23rd April 2019.",2020,Social Stories™ are a highly personalised intervention aiming to give children with ASC social information or describing an otherwise difficult situation or skill.,"['Approximately 278 school based staff will be recruited to provide school based information about participating children with approximately 140 recruited to deliver the intervention', 'primary schools', 'primary school children with a diagnosis of ASC', 'children with a diagnosis of Autism Spectrum Conditions (ASC', 'A multi-site pragmatic cluster', '278 participants (aged 4-11) with a clinical diagnosis of ASC, currently attending primary school in the North of England', 'Autism Spectrum Social Stories']","['RCT', 'Social Stories']",['Social Responsiveness Scale Second Edition (SRS-2) completed by school based staff at 6 months'],"[{'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0557296', 'cui_str': 'Attending primary school'}, {'cui': 'C0014282', 'cui_str': 'England'}]",[],"[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441795', 'cui_str': 'Second edition'}, {'cui': 'C0175693', 'cui_str': 'Russell-Silver syndrome'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",278.0,0.14527,Social Stories™ are a highly personalised intervention aiming to give children with ASC social information or describing an otherwise difficult situation or skill.,"[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Wright', 'Affiliation': 'Child Oriented Mental Health Intervention Centre, Leeds and York Partnership NHS Foundation Trust, York, UK. barry.wright1@nhs.net.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Teige', 'Affiliation': 'Child Oriented Mental Health Intervention Centre, Leeds and York Partnership NHS Foundation Trust, York, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Watson', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hodkinson', 'Affiliation': 'Child Oriented Mental Health Intervention Centre, Leeds and York Partnership NHS Foundation Trust, York, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Marshall', 'Affiliation': 'Centre for Reviews and Dissemination, University of York, York, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Varley', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Allgar', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Mandefield', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Parrott', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kingsley', 'Affiliation': 'Child Oriented Mental Health Intervention Centre, Leeds and York Partnership NHS Foundation Trust, York, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hargate', 'Affiliation': 'Child Oriented Mental Health Intervention Centre, Leeds and York Partnership NHS Foundation Trust, York, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Mitchell', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'McMillan', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hewitt', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}]",BMC psychology,['10.1186/s40359-020-00427-z']
2352,32532356,Safety and efficacy assessment of allogeneic human dental pulp stem cells to treat patients with severe COVID-19: structured summary of a study protocol for a randomized controlled trial (Phase I / II).,"OBJECTIVES


To assess the safety and therapeutic effects of allogeneic human dental pulp stem cells (DPSCs) in treating severe pneumonia caused by COVID-19.
TRIAL DESIGN


This is a single centre, two arm ratio 1:1, triple blinded, randomized, placebo-controlled, parallel group, clinical trial.
PARTICIPANTS


Twenty serious COVID-19 cases will be enrolled in the trial from April 6th to December 31st 2020.
INCLUSION CRITERIA


hospitalised patients at Renmin Hospital of Wuhan University satisfy all criteria as below: 1)Adults aged 18-65 years;2)Voluntarily participate in this clinical trial and sign the ""informed consent form"" or have consent from a legal representative.3)Diagnosed with severe pneumonia of COVID-19: nucleic acid test SARS-CoV-2 positive; respiratory distress (respiratory rate > 30 times / min); hypoxia (resting oxygen saturation < 93% or arterial partial pressure of oxygen / oxygen concentration < 300 mmHg).4)COVID-19 featured lung lesions in chest X-ray image.
EXCLUSION CRITERIA


Patients will be excluded from the study if they meet any of the following criteria. 1.Patients have received other experimental treatment for COVID-19 within the last 30 days;2.Patients have severe liver condition (e.g., Child Pugh score >=C or AST> 5 times of the upper limit);3.Patients with severe renal insufficiency (estimated glomerular filtration rate <=30mL / min/1.73 m 2 ) or patients receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis;4.Patients who are co-infected with HIV, hepatitis B, tuberculosis, influenza virus, adenovirus or other respiratory infection viruses;5.Female patients who have no sexual protection in the last 30 days prior to the screening assessment;6.Pregnant or lactating women or women using estrogen contraception;7.Patients who are planning to become pregnant during the study period or within 6 months after the end of the study period;8.Other conditions that the researchers consider not suitable for participating in this clinical trial.
INTERVENTION AND COMPARATOR


There will be two study groups: experimental and control. Both will receive all necessary routine treatment for COVID-19. The experimental group will receive an intravenous injection of dental pulp stem cells suspension (3.0x10 7  human DPSCs in 30ml saline solution) on day 1, 4 and 7; The control group will receive an equal amount of saline (placebo) on the same days. Clinical and laboratory observations will be performed for analysis during a period of 28 days for each case since the commencement of the study.
MAIN OUTCOMES


1. Primary outcome The primary outcome is Time To Clinical Improvement (TTCI). By definition, TTCI is the time (days) it takes to downgrade two levels from the following six ordered grades [(grade 1) discharge to (grade 6) death] in the clinical state of admission to the start of study treatments (hDPSCs or placebo). Six grades of ordered variables: GradeDescriptionGrade 1:Discharged of patient;Grade 2:Hospitalized without oxygen supplement;Grade 3:Hospitalized, oxygen supplement is required, but NIV / HFNC is not required;Grade 4:Hospitalized in intensive care unit, and NIV / HFNC treatment is required;Grade 5:Hospitalized in intensive care unit, requiring ECMO and/or IMV;Grade 6:Death.
ABBREVIATIONS


NIV, non-invasive mechanical ventilation; HFNC, high-flow nasal catheter; IMV, invasive mechanical ventilation. 2. Secondary outcomes 2.1 vital signs: heart rate, blood pressure (systolic blood pressure, diastolic blood pressure). During the screening period, hospitalization every day (additional time points of D1, D4, D7 30min before injection, 2h ± 30min, 24h ± 30min after the injection) and follow-up period D90 ± 3 days. 2.2 Laboratory examinations: during the screening period, 30 minutes before D1, D4, D7 infusion, 2h ± 30min, 24h ± 30min after the end of infusion, D10, D14, D28 during hospitalization or discharge day and follow-up period D90 ± 3 days. 2.3 Blood routine: white blood cells, neutrophils, lymphocytes, monocytes, eosinophils, basophils, neutrophils, lymphocytes, monocytes, eosinophils Acidic granulocyte count, basophil count, red blood cell, hemoglobin, hematocrit, average volume of red blood cells, average red blood cell Hb content, average red blood cell Hb concentration, RDW standard deviation, RDW coefficient of variation, platelet count, platelet specific platelet average Volume, platelet distribution width,% of large platelets; 2.4 Liver and kidney function tests: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, γ-glutamyl transferase, prealbumin, total protein, albumin, globulin, white / globule ratio , Total bilirubin, direct bilirubin, cholinesterase, urea, creatinine, total carbon dioxide, uric acid glucose, potassium, sodium, chlorine, calcium, corrected calcium, magnesium, phosphorus, calcium and phosphorus product, anion gap, penetration Pressure, total cholesterol, triacylglycerol, high density lipoprotein cholesterol, Low density lipoprotein cholesterol, lipoprotein a, creatine kinase, lactate dehydrogenase, estimated glomerular filtration rate. 2.5 Inflammation indicators: hypersensitive C-reactive protein, serum amyloid (SAA); 2.6 Infectious disease testing: Hepatitis B (HBsAg, HBsAb, HBeAg, HBeAb, HBcAb), Hepatitis C (Anti-HCV), AIDS (HIVcombin), syphilis (Anti-TP), cytomegalovirus CMV-IgM, cytomegalovirus CMV-IgG; only during the screening period and follow-up period D90 ± 3. 2.7 Immunological testing: Collect peripheral blood to detect the phenotype of T lymphocyte, B lymphocyte, natural killer cell, Macrophage and neutrophil by using flow cytometry. Collect peripheral blood to detect the gene profile of mononuclear cells by using single-cell analyses. Collect peripheral blood serum to detect various immunoglobulin changes: IgA, IgG, IgM, total IgE; Collect peripheral blood serum to explore the changes of cytokines, Th1 cytokines (IL-1 β, IL-2, TNF-a, ITN-γ), Th2 cytokines (IL-4, IL-6, IL -10). 2.8 Pregnancy test: blood β-HCG, female subjects before menopause are examined during the screening period and follow-up period D90 ± 3. 2.9 Urine routine: color, clarity, urine sugar, bilirubin, ketone bodies, specific gravity, pH, urobilinogen, nitrite, protein, occult blood, leukocyte enzymes, red blood cells, white blood cells, epithelial cells, non-squamous epithelial cells , Transparent cast, pathological cast, crystal, fungus; 2.10 Stool Routine: color, traits, white blood cells, red blood cells, fat globules, eggs of parasites, fungi, occult blood (chemical method), occult blood (immune method), transferrin (2h ± 30min after the injection and not detected after discharge).
RANDOMIZATION


Block randomization method will be applied by computer to allocate the participants into experimental and control groups. The random ratio is 1:1.
BLINDING (MASKING)


Participants, outcomes assessors and investigators (including personnel in laboratory and imaging department who issue the sample report or image observations) will be blinded. Injections of cell suspension and saline will be coded in accordance with the patient's randomisation group. The blind strategy is kept by an investigator who does not deliver the medical care or assess primary outcome results.
NUMBERS TO BE RANDOMIZED (SAMPLE SIZE)


Twenty participants will be randomized to the experimental and control groups (10 per group).
TRIAL STATUS


Protocol version number, hDPSC-CoVID-2019-02-2020 Version 2.0, March 13, 2020. Patients screening commenced on 16 th  April and an estimated date of the recruitment of the final participants will be around end of July. .
TRIAL REGISTRATION


Registration: World Health Organization Trial Registry: ChiCTR2000031319; March 27,2020. ClinicalTrials.gov Identifier: NCT04336254; April 7, 2020 Other Study ID Numbers: hDPSC-CoVID-2019-02-2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.","['hospitalised patients at Renmin Hospital of Wuhan University satisfy all criteria as below', 'Twenty participants', '2.3 Blood routine', 'Twenty serious COVID-19 cases will be enrolled in the trial from April 6th to December 31st 2020', '30 days;2.Patients have severe liver condition (e.g., Child Pugh score >=C or AST> 5 times of the upper limit);3.Patients with severe renal insufficiency (estimated glomerular filtration rate <=30mL / min/1.73 m 2 ) or patients receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis;4.Patients who are co-infected with HIV, hepatitis B, tuberculosis, influenza virus, adenovirus or other respiratory infection viruses;5.Female patients who have no sexual protection in the last 30 days prior to the screening', '1)Adults aged 18-65 years;2)Voluntarily participate in this clinical trial and sign the ""informed consent form"" or have consent from a legal representative.3)Diagnosed with severe pneumonia of COVID-19: nucleic acid test SARS-CoV-2 positive; respiratory distress (respiratory rate > 30 times / min', 'Protocol version number, hDPSC-CoVID-2019-02-2020 Version 2.0, March 13, 2020', '\n\n\nParticipants, outcomes assessors and investigators (including personnel in laboratory and imaging department who issue the sample report or image observations', '2020 Other Study ID Numbers: hDPSC-CoVID-2019-02-2020', 'female subjects before menopause are examined during the screening period and follow-up period D90 ± 3. 2.9', 'patients with severe COVID-19']","['allogeneic human dental pulp stem cells', 'intravenous injection of dental pulp stem cells suspension (3.0x10 7  human DPSCs in 30ml saline solution', 'control group will receive an equal amount of saline (placebo', 'hypoxia (resting oxygen saturation < 93% or arterial partial pressure of oxygen / oxygen concentration < 300 mmHg).4)COVID-19 featured lung lesions in chest X-ray image', 'allogeneic human dental pulp stem cells (DPSCs', 'cell suspension and saline', 'placebo']","['Time To Clinical Improvement (TTCI', 'Urine routine: color, clarity, urine sugar, bilirubin, ketone bodies, specific gravity, pH, urobilinogen, nitrite, protein, occult blood, leukocyte enzymes, red blood cells, white blood cells, epithelial cells, non-squamous epithelial cells , Transparent cast, pathological cast, crystal, fungus; 2.10 Stool Routine: color, traits, white blood cells, red blood cells, fat globules, eggs of parasites, fungi, occult blood (chemical method), occult blood (immune method), transferrin (2h ± 30min after the injection and not detected after discharge', 'white blood cells, neutrophils, lymphocytes, monocytes, eosinophils, basophils, neutrophils, lymphocytes, monocytes, eosinophils Acidic granulocyte count, basophil count, red blood cell, hemoglobin, hematocrit, average volume of red blood cells, average red blood cell Hb content, average red blood cell Hb concentration, RDW standard deviation, RDW coefficient of variation, platelet count, platelet specific platelet average Volume, platelet distribution width,% of large platelets; 2.4 Liver and kidney function tests: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, γ-glutamyl transferase, prealbumin, total protein, albumin, globulin, white / globule ratio , Total bilirubin, direct bilirubin, cholinesterase, urea, creatinine, total carbon dioxide, uric acid glucose, potassium, sodium, chlorine, calcium, corrected calcium, magnesium, phosphorus, calcium and phosphorus product, anion gap, penetration Pressure, total cholesterol, triacylglycerol, high density lipoprotein cholesterol, Low density lipoprotein cholesterol, lipoprotein a, creatine kinase, lactate dehydrogenase, estimated glomerular filtration rate', 'vital signs: heart rate, blood pressure (systolic blood pressure, diastolic blood pressure', 'T lymphocyte, B lymphocyte, natural killer cell, Macrophage and neutrophil', 'Safety and efficacy assessment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4050412', 'cui_str': 'Child-Pugh score'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0439090', 'cui_str': '<='}, {'cui': 'C3649547', 'cui_str': 'Continuous renal replacement therapy'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0029341', 'cui_str': 'Family Orthomyxoviridae'}, {'cui': 'C0001483', 'cui_str': 'Adenoviridae'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0009797', 'cui_str': 'Informed Consent Forms'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1301860', 'cui_str': 'Legal'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0587111', 'cui_str': 'Before menopause'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517641', 'cui_str': '2.9'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}, {'cui': 'C0021494', 'cui_str': 'Intravenous injection'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0428646', 'cui_str': 'Oxygen concentration'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0577916', 'cui_str': 'Lesion of lung'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property)'}, {'cui': 'C0017979', 'cui_str': 'Glycosuria'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0022631', 'cui_str': 'Ketone body'}, {'cui': 'C0037786', 'cui_str': 'Specific gravity'}, {'cui': 'C0042052', 'cui_str': 'Urobilinogen'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0028792', 'cui_str': 'Occult blood screening'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0014597', 'cui_str': 'Epithelial cell'}, {'cui': 'C1545484', 'cui_str': 'Non-squamous epithelial cell'}, {'cui': 'C0522503', 'cui_str': 'Translucent'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0016832', 'cui_str': 'Fungi'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0443611', 'cui_str': 'Fat globule'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}, {'cui': 'C0201683', 'cui_str': 'Chemical method'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0040679', 'cui_str': 'Transferrin'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0442737', 'cui_str': 'Not detected'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0004827', 'cui_str': 'Basophils'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0857490', 'cui_str': 'Granulocyte count'}, {'cui': 'C0200641', 'cui_str': 'Basophil count'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0427460', 'cui_str': 'Red cell distribution width determination'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0427566', 'cui_str': 'Macrothrombocyte'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0678107', 'cui_str': 'Glutamyl transferase'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0017649', 'cui_str': 'Globulin'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0201916', 'cui_str': 'Bilirubin, direct measurement'}, {'cui': 'C0008429', 'cui_str': 'Cholinesterase'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0008209', 'cui_str': 'Chlorine'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C2732404', 'cui_str': 'Corrected measurement of calcium'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0003074', 'cui_str': 'Anion gap'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0065058', 'cui_str': 'Lipoprotein (a)'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0022688', 'cui_str': 'NK-cell'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",20.0,0.369317,"In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.","[{'ForeName': 'Qingsong', 'Initials': 'Q', 'LastName': 'Ye', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, 430060, Hubei, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Beijing Institute of Radiation Medicine, Beijing, 100850, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Xia', 'Affiliation': 'Beijing SH Biotechnology Co., Ltd., Beijing, 100070, China.'}, {'ForeName': 'Chenliang', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, 430060, Hubei, China.'}, {'ForeName': 'Zhiming', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, 430060, Hubei, China.'}, {'ForeName': 'Zun-En', 'Initials': 'ZE', 'LastName': 'Xia', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, 430060, Hubei, China.'}, {'ForeName': 'Zhan', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, 430060, Hubei, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, 430060, Hubei, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yehenala', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, 430060, Hubei, China.'}, {'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, 430060, Hubei, China.'}, {'ForeName': 'Gangqiao', 'Initials': 'G', 'LastName': 'Zhou', 'Affiliation': 'Beijing Institute of Radiation Medicine, Beijing, 100850, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Hu', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, 430060, Hubei, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Tianjin Fopcells Pharmaceutical Technology Co., Ltd, Tianjin, 300074, China.'}, {'ForeName': 'Chu-Tse', 'Initials': 'CT', 'LastName': 'Wu', 'Affiliation': 'Beijing Institute of Radiation Medicine, Beijing, 100850, China. 139100026365@163.com.'}, {'ForeName': 'Songling', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'School of Stomatology, Capital Medical University, Beijing, 100006, China. slwang@ccmu.edu.cn.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Tianyou Hospital, Wuhan University of Science and Technology, Wuhan, 430064, Hubei, China. helen-1101@hotmail.com.'}]",Trials,['10.1186/s13063-020-04380-5']
2353,32533013,"Local tissue electrical parameters predict oral mucositis in HNSCC patients: A diagnostic accuracy double-blind, randomized controlled trial.","Oral Mucositis (OM) is a common adverse effect of head and neck squamous cell carcinoma (HNSCC) treatment. The purpose of this study was to investigate the significance of early changes in tissue electrical parameters (TEPs) in predicting the development of OM in HNSCC patients receiving radiation therapy (RT). The current study combined two study designs. The first was a case-control study. The control group comprised of RT patients who did not receive head and neck RT, and patients with HNSCC who received RT comprised the case group. In the second part of the study, the case group was included in a parallel cohort. A total of 320 patients were assessed for eligibility, and 135 patients were enrolled. Double blinding was performed, and neither the patients nor the care providers knew the measured parameters. The primary outcome was the detection of between-group changes in local TEPs over the follow-up period. The secondary outcome was the appearance of OM grades II, III, or IV and the predictive value of local TEPs in determining the incidence of OM after RT. The variables, impedance module, resistance, reactance, phase angle, and capacitance, were analyzed by the receiver operator curves (ROC). The case and control groups did not differ in demographic and clinical characteristics. Radiation therapy increased the local impedance module, resistance, reactance, and phase angle and reduced the local tissue capacitance in both groups. Evaluation of TEPs in the first week of RT correlated with the development of OM lesions during cancer therapy. ROC analysis showed that local impedance module and resistance presented higher specificity than did other parameters in predicting OM. In conclusion, local tissue electrical parameters measured at the first RT week can be useful tools to predict oral mucositis.",2020,"Radiation therapy increased the local impedance module, resistance, reactance, and phase angle and reduced the local tissue capacitance in both groups.","['HNSCC patients receiving radiation therapy (RT', 'A total of 320 patients were assessed for eligibility, and 135 patients were enrolled', 'head and neck squamous cell carcinoma (HNSCC', 'HNSCC patients']","['Radiation therapy', 'TEPs']","['local tissue electrical parameters', 'local impedance module, resistance, reactance, and phase angle and reduced the local tissue capacitance', 'Oral Mucositis (OM', 'appearance of OM grades II, III, or IV and the predictive value of local TEPs', 'detection of between-group changes in local TEPs', 'variables, impedance module, resistance, reactance, phase angle, and capacitance', 'OM lesions']","[{'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C4517566', 'cui_str': '135'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0242264', 'cui_str': 'Capacitance, Electrical'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",320.0,0.028312,"Radiation therapy increased the local impedance module, resistance, reactance, and phase angle and reduced the local tissue capacitance in both groups.","[{'ForeName': 'Gabriela Luize Guimarães', 'Initials': 'GLG', 'LastName': 'Sanches', 'Affiliation': 'Department of Dentistry, Universidade Estadual de Montes Claros, Minas Gerais, Montes Claros, Brazil.'}, {'ForeName': 'Agna Soares', 'Initials': 'AS', 'LastName': 'da Silva Menezes', 'Affiliation': 'Department of Dentistry, Universidade Estadual de Montes Claros, Minas Gerais, Montes Claros, Brazil.'}, {'ForeName': 'Laércio Ives', 'Initials': 'LI', 'LastName': 'Santos', 'Affiliation': 'Instituto Federal do Norte de Minas Gerais, Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'Cristina Paixão', 'Initials': 'CP', 'LastName': 'Durães', 'Affiliation': 'Department of Dentistry, Universidade Estadual de Montes Claros, Minas Gerais, Montes Claros, Brazil.'}, {'ForeName': 'Larissa Lopes', 'Initials': 'LL', 'LastName': 'Fonseca', 'Affiliation': 'Department of Dentistry, Universidade Estadual de Montes Claros, Minas Gerais, Montes Claros, Brazil.'}, {'ForeName': 'Marcelo Perim', 'Initials': 'MP', 'LastName': 'Baldo', 'Affiliation': 'Department of Pathophysiology, Universidade Estadual de Montes Claros, Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'Thais', 'Initials': 'T', 'LastName': 'de Oliveira Faria', 'Affiliation': 'Department of Pathophysiology, Universidade Estadual de Montes Claros, Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'Luciano Alves', 'Initials': 'LA', 'LastName': 'de Araújo Andrade', 'Affiliation': 'Dilson Godinho Hospital, Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'Petr Iakovlevitch', 'Initials': 'PI', 'LastName': 'Ekel', 'Affiliation': 'Pontifícia Universidade Católica de Minas Gerais, Programa de Pós-Graduação em Engenharia Elétrica, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Sérgio Henrique Sousa', 'Initials': 'SHS', 'LastName': 'Santos', 'Affiliation': 'Institute of Agricultural Sciences, Universidade Federal de Minas Gerais (UFMG), Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'Alfredo Maurício Batista', 'Initials': 'AMB', 'LastName': 'de Paula', 'Affiliation': 'Department of Dentistry, Universidade Estadual de Montes Claros, Minas Gerais, Montes Claros, Brazil.'}, {'ForeName': 'Lucyana Conceição', 'Initials': 'LC', 'LastName': 'Farias', 'Affiliation': 'Department of Dentistry, Universidade Estadual de Montes Claros, Minas Gerais, Montes Claros, Brazil.'}, {'ForeName': 'Marcos Flávio Silveira Vasconcelos', 'Initials': 'MFSV', 'LastName': ""D'Angelo"", 'Affiliation': 'Department of Computer Science, Universidade Estadual de Montes Claros, Minas Gerais, Montes Claros, Brazil.'}, {'ForeName': 'André Luiz Sena', 'Initials': 'ALS', 'LastName': 'Guimarães', 'Affiliation': 'Department of Dentistry, Universidade Estadual de Montes Claros, Minas Gerais, Montes Claros, Brazil. andreluizguimaraes@gmail.com.'}]",Scientific reports,['10.1038/s41598-020-66351-9']
2354,32533015,Influence of the long-term use of oral hygiene products containing stannous ions on the salivary microbiome - a randomized controlled trial.,"Oral hygiene products containing tin are suitable to prevent erosive tooth wear, yet effects on the oral microbiota are not known yet. Therefore, this study determined the salivary microbiome of 16 participants using products with stannous ions for three years (TG) compared with a control group (CG) to assess their influence on the microbiota. Participants were included in a randomized controlled clinical trial (RCT) with biannual visits. Illumina Miseq sequencing revealed as most abundant genera: Streptococcus (TG 14.3%; CG 13.0%), Veillonella (TG 11.3%; CG 10.9%), Prevotella (TG 7.0%; CG 9.8%), Haemophilus (TG 6.6%; CG 7.2%), Porphyromonas (TG 5.9%, CG 5.1%), Leptotrichia (TG 5.8%; CG 4.9%), Actinomyces (TG 4.0%; CG 4.6%) and Neisseria (TG 5.4%; CG 4.2%). Beta-Diversity was not significantly different between groups at both time points, although significant differences between groups were found for certain taxa after three years. The genus Prevotella was found in higher abundance in CG whereas Neisseria and Granulicatella, health-associated taxa, were found more abundantly in TG. Salivary microbiota after three years reflected a composition associated with oral health, hence continual use as a preventive measure for dental erosion can be considered safe and benefitting oral health for patients with a high risk of erosion.",2020,"Beta-Diversity was not significantly different between groups at both time points, although significant differences between groups were found for certain taxa after three years.","['patients with a high risk of erosion', '16 participants using products with stannous ions for three years (TG']","['control group (CG', 'oral hygiene products containing stannous']","['Beta-Diversity', 'Salivary microbiota']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0022023', 'cui_str': 'Ions'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}]",16.0,0.0518899,"Beta-Diversity was not significantly different between groups at both time points, although significant differences between groups were found for certain taxa after three years.","[{'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Anderson', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany. annette.anderson@uniklinik-freiburg.de.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Al-Ahmad', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Schlueter', 'Affiliation': 'Division for Cariology, Department of Operative Dentistry and Periodontology, Medical Center- University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Frese', 'Affiliation': 'Department of Conservative Dentistry, Clinic for Oral, Dental and Maxillofacial Diseases, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hellwig', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Binder', 'Affiliation': 'Institute for Prevention and Cancer Epidemiology, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}]",Scientific reports,['10.1038/s41598-020-66412-z']
2355,32533085,Remote ischemic conditioning in active ulcerative colitis: An explorative randomized clinical trial.,"Remote ischemic conditioning (RIC) by repetitive brief periods of limb ischemia and reperfusion renders organs more resistant to ischemic injury. The protection is partly through down-regulation of the inflammatory response. Our aim was to investigate the clinical and anti-inflammatory effects of RIC in patients with active ulcerative colitis (UC). We included 22 patients with active UC in this explorative, randomized, sham-controlled clinical trial. The patients were randomly assigned 1:1 to RIC (induced in the arm through four cycles of 5-min inflation and 5-min deflation of a blood-pressure cuff) or sham (incomplete inflation of the blood-pressure cuff) once daily for 10 days. Outcome variables were measured at baseline and on day 11. When compared with sham, RIC did not affect inflammation in the UC patients measured by fecal calprotectin, plasma C-reactive protein, Mayo Score, Mayo Endoscopic Subscore, Nancy Histological Index or inflammatory cytokines involved in UC and RIC. The mRNA and miRNA expression profiles in the UC patients were measured by RNA sequencing and multiplexed hybridization, respectively, but were not significantly affected by RIC. We used the Langendorff heart model to assess activation of the organ protective mechanism induced by RIC, but could not confirm activation of the organ protective mechanism in the UC patients.",2020,"When compared with sham, RIC did not affect inflammation in the UC patients measured by fecal calprotectin, plasma C-reactive protein, Mayo Score, Mayo Endoscopic Subscore, Nancy Histological Index or inflammatory cytokines involved in UC and RIC.","['22 patients with active UC', 'active ulcerative colitis', 'patients with active ulcerative colitis (UC']","['5-min inflation and 5-min deflation of a blood-pressure cuff) or sham (incomplete inflation of the blood-pressure cuff', 'Remote ischemic conditioning', 'RIC', 'Remote ischemic conditioning (RIC']","['fecal calprotectin, plasma C-reactive protein, Mayo Score, Mayo Endoscopic Subscore, Nancy Histological Index or inflammatory cytokines involved in UC and RIC', 'mRNA and miRNA expression profiles']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0021398', 'cui_str': 'Economic Inflation'}, {'cui': 'C0180208', 'cui_str': 'Blood pressure cuff'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",22.0,0.210465,"When compared with sham, RIC did not affect inflammation in the UC patients measured by fecal calprotectin, plasma C-reactive protein, Mayo Score, Mayo Endoscopic Subscore, Nancy Histological Index or inflammatory cytokines involved in UC and RIC.","[{'ForeName': 'Line E', 'Initials': 'LE', 'LastName': 'Godskesen', 'Affiliation': 'Department of Medical Gastroenterology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Lassen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Nichlas R', 'Initials': 'NR', 'LastName': 'Jespersen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Majken', 'Initials': 'M', 'LastName': 'Siersbæk', 'Affiliation': 'Department of Biochemistry and Molecular Biology, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Interdisciplinary Nanoscience Center (iNANO), Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Nielsen', 'Affiliation': 'Internal Medicine & Emergency Department, Odense University Hospital - Svendborg Sygehus, Svendborg, Denmark.'}, {'ForeName': 'Sara K', 'Initials': 'SK', 'LastName': 'Tjønnfjord', 'Affiliation': 'Department of Medical Gastroenterology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Grøntved', 'Affiliation': 'Department of Biochemistry and Molecular Biology, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Gunvor', 'Initials': 'G', 'LastName': 'Madsen', 'Affiliation': 'Department of Pathology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Kjems', 'Affiliation': 'Interdisciplinary Nanoscience Center (iNANO), Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Hans E', 'Initials': 'HE', 'LastName': 'Bøtker', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Schmidt', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Aleksander', 'Initials': 'A', 'LastName': 'Krag', 'Affiliation': 'Department of Medical Gastroenterology, Odense University Hospital, Odense, Denmark. aleksander.krag@rsyd.dk.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kjeldsen', 'Affiliation': 'Department of Medical Gastroenterology, Odense University Hospital, Odense, Denmark.'}]",Scientific reports,['10.1038/s41598-020-65692-9']
2356,32534250,External trigeminal nerve stimulation for drug resistant epilepsy: A randomized controlled trial.,"BACKGROUND


External trigeminal nerve stimulation (ETNS) is an emergent, non-invasive neurostimulation therapy delivered bilaterally with adhesive skin electrodes. In previous studies, ETNS was associated to a decrease in seizure frequency in patients with focal drug-resistant epilepsy (DRE).
OBJECTIVE


To determine the long-term efficacy and tolerability of ETNS in patients with focal DRE. Moreover, to explore whether its efficacy depends on the epileptogenic zone (frontal or temporal), and its impact on mood, cognitive function, quality of life, and trigeminal nerve excitability.
METHODS


Forty consecutive patients with frontal or temporal DRE, unsuitable for surgery, were randomized to ETNS or usual medical treatment. Participants were evaluated at 3, 6 and 12 months for efficacy, side effects, mood scales, neuropsychological tests and trigeminal nerve excitability.
RESULTS


Subjects had a median of 15 seizures per month and had tried a median of 12.5 antiepileptic drugs. At 12 months, percentage of responders was 50% in ETNS group and 0% in control group. Seizure frequency in ETNS group decreased by -43.5% from baseline. Temporal epilepsy subgroup responded better than frontal epilepsy subgroup (55.56% vs. 45.45%, respectively). Median stimulation intensity was 6.2 mA. ETNS improved quality of life, but not anxiety or depression. Long-term ETNS affected neither neuropsychological function, nor trigeminal nerve excitability. No relevant adverse events were observed.
CONCLUSIONS


ETNS is an effective and well-tolerated therapy for focal DRE. Patients with temporal epilepsy showed a better response than those with frontal epilepsy. Future studies with larger populations may define its role compared to other neurostimulation techniques.
CLASSIFICATION OF EVIDENCE


This study provides Class II evidence that ETNS reduces seizure frequency in patients with focal DRE.",2020,"Temporal epilepsy subgroup responded better than frontal epilepsy subgroup (55.56% vs. 45.45%, respectively).","['Patients with temporal epilepsy', 'Subjects had a median of 15 seizures per month and had tried a median of 12.5 antiepileptic drugs', 'patients with focal drug-resistant epilepsy (DRE', 'drug resistant epilepsy', 'Forty consecutive patients with frontal or temporal DRE, unsuitable for surgery', 'patients with focal DRE']","['ETNS or usual medical treatment', 'External trigeminal nerve stimulation (ETNS', 'ETNS', 'External trigeminal nerve stimulation']","['quality of life', 'seizure frequency', 'neuropsychological function, nor trigeminal nerve excitability', 'efficacy, side effects, mood scales, neuropsychological tests and trigeminal nerve excitability', 'Seizure frequency', 'Median stimulation intensity', 'adverse events', 'anxiety or depression', 'mood, cognitive function, quality of life, and trigeminal nerve excitability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C1096063', 'cui_str': 'Refractory epilepsy'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0040996', 'cui_str': 'Trigeminal nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0040996', 'cui_str': 'Trigeminal nerve structure'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",40.0,0.130105,"Temporal epilepsy subgroup responded better than frontal epilepsy subgroup (55.56% vs. 45.45%, respectively).","[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Gil-López', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain. Electronic address: fran.gil.lopez@gmail.com.""}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Boget', 'Affiliation': 'Epilepsy Unit, Department of Neuropsychology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Manzanares', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Donaire', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Estefanía', 'Initials': 'E', 'LastName': 'Conde-Blanco', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Baillés', 'Affiliation': 'Epilepsy Unit, Department of Psychiatry, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Pintor', 'Affiliation': 'Epilepsy Unit, Department of Psychiatry, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Setoaín', 'Affiliation': 'Epilepsy Unit, Department of Nuclear Medicine, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Bargalló', 'Affiliation': 'Epilepsy Unit, Department of Neurorradiology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Navarro', 'Affiliation': 'Electromyography Unit, Neurophysiology, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Casanova', 'Affiliation': 'Electromyography Unit, Neurophysiology, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Valls', 'Affiliation': 'Electromyography Unit, Neurophysiology, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Roldán', 'Affiliation': 'Epilepsy Unit, Department of Neurosurgery, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Rumià', 'Affiliation': 'Epilepsy Unit, Department of Neurosurgery, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Casanovas', 'Affiliation': 'Medical Statistics Core Facility, IDIBAPS-Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Domenech', 'Affiliation': 'Medical Statistics Core Facility, IDIBAPS-Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Ferrán', 'Initials': 'F', 'LastName': 'Torres', 'Affiliation': 'Medical Statistics Core Facility, IDIBAPS-Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Carreño', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}]",Brain stimulation,['10.1016/j.brs.2020.06.005']
2357,32534361,Long-term effects of mindfulness-based cognitive therapy in patients with obsessive-compulsive disorder and residual symptoms after cognitive behavioral therapy: Twelve-month follow-up of a randomized controlled trial.,"We examined the long-term efficacy of mindfulness-based cognitive therapy (MBCT) compared to a psychoeducation group as an active control condition in patients with obsessive-compulsive disorder (OCD) with residual symptoms of OCD after cognitive behavioral therapy. A total of 125 patients were included in a bicentric, interviewer-blind, randomized, and actively controlled trial and were assigned to either an MBCT group (n = 61) or a psychoeducation group (n = 64). Patients' demographic characteristics and the results from our previous assessments have already been reported (Külz et al., 2019). At the 12-month follow-up the completion rate was 80%. OCD symptoms were reduced from baseline to follow-up assessment with a large effect, but no difference was found between groups. Exploratory analyses showed that a composite score of time occupied by obsessive thoughts, distress associated with obsessive thoughts, and interference due to obsessive thoughts differed between groups in the per-protocol analysis, with a stronger reduction in the MBCT group. At the 12-month follow-up, the two groups showed a similar reduction of symptoms. However, preliminary evidence indicates that MBCT has a superior effect on some aspects of OCD. This should be replicated in future studies.",2020,"OCD symptoms were reduced from baseline to follow-up assessment with a large effect, but no difference was found between groups.","['patients with obsessive-compulsive disorder and residual symptoms after cognitive behavioral therapy', 'patients with obsessive-compulsive disorder (OCD) with residual symptoms of OCD after cognitive behavioral therapy', 'A total of 125 patients']","['MBCT', 'mindfulness-based cognitive therapy', 'mindfulness-based cognitive therapy (MBCT']","['OCD symptoms', 'composite score of time occupied by obsessive thoughts, distress associated with obsessive thoughts, and interference due to obsessive thoughts']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319551', 'cui_str': '125'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0679048', 'cui_str': 'Obsessive thoughts'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",125.0,0.0493293,"OCD symptoms were reduced from baseline to follow-up assessment with a large effect, but no difference was found between groups.","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Cludius', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Martinistr, 52, 20246 Hamburg, Germany. Electronic address: barbara.cludius@psy.lmu.de.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Landmann', 'Affiliation': 'University Medical Center Freiburg, Department of Psychiatry and Psychotherapy, Hauptstr. 6, 79104 Freiburg, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Rose', 'Affiliation': 'University Medical Center Freiburg, Department of Psychiatry and Psychotherapy, Hauptstr. 6, 79104 Freiburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Heidenreich', 'Affiliation': 'Esslingen University of Applied Sciences; Flandernstraße 101, 73732 Esslingen am Neckar, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Hottenrott', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Martinistr, 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Schröder', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Martinistr, 52, 20246 Hamburg, Germany; Institute for Sex Research, Sexual Medicine and Forensic Psychiatry, Germany.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Jelinek', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Martinistr, 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Voderholzer', 'Affiliation': 'University Medical Center Freiburg, Department of Psychiatry and Psychotherapy, Hauptstr. 6, 79104 Freiburg, Germany;; Schoen Clinic Roseneck, Am Roseneck 6, 83209 Prien am Chiemsee, Germany; Clinic for Psychiatry and Psychotherapy, Ludwig-Maximilians-University, Nußbaumstraße 7, 80336 Munich, Germany.'}, {'ForeName': 'Anne Katrin', 'Initials': 'AK', 'LastName': 'Külz', 'Affiliation': 'University Medical Center Freiburg, Department of Psychiatry and Psychotherapy, Hauptstr. 6, 79104 Freiburg, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Martinistr, 52, 20246 Hamburg, Germany.'}]",Psychiatry research,['10.1016/j.psychres.2020.113119']
2358,32534369,Hydroxychloroquine/ chloroquine as a treatment choice or prophylaxis for Covid-19 at the primary care level in developing countries: A Primum non Nocere dilemma.,"The Food and Drug Administration (FDA) warned against the use of Hydroxychloroquine or chloroquine for Covid-19 outside of a hospital or a clinical trial setting due to the risk of QT interval prolongation, ventricular tachycardia and the increased risk of these complications when combined with some antibiotics such as azithromycin. Several studies have reported no benefit of Hydroxychloroquine or chloroquine, when used alone or with a macrolide in COVID-19 hospitalized patients. Despite these warnings, in several developing countries the official guidelines for treatment of Covid-19 patients at the primary care level recommend Hydroxychloroquine and azithromycin, among other treatments, as the first-choice for mild symptomatic Covid-19 patients, asymptomatic contacts or for prophylaxis. In our opinion there is a primum non nocere dilemma during this Covid-19 pandemic. In order to solve this bioethical problem, we strongly recommend that a randomized controlled trial in a primary care setting be carried out as a matter of urgency in these areas of the world.",2020,"Several studies have reported no benefit of Hydroxychloroquine or chloroquine, when used alone or with a macrolide in COVID-19 hospitalized patients.",['COVID-19 hospitalized patients'],"['azithromycin', 'Hydroxychloroquine/ chloroquine', 'Hydroxychloroquine or chloroquine', 'Hydroxychloroquine and azithromycin']",[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]",[],,0.0510268,"Several studies have reported no benefit of Hydroxychloroquine or chloroquine, when used alone or with a macrolide in COVID-19 hospitalized patients.","[{'ForeName': 'Marco T Medina', 'Initials': 'MTM', 'LastName': 'Chevalier', 'Affiliation': 'Faculty of Medical Sciences, National Autonomous University of Honduras, WFN Regional Director for Latin America, Tegucigalpa, Honduras. Electronic address: marcotmedina@yahoo.com.'}, {'ForeName': 'Sir Salvador', 'Initials': 'SS', 'LastName': 'Moncada', 'Affiliation': 'Manchester Cancer Research Centre, The University of Manchester, Manchester, UK.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116972']
2359,32534376,Fatty acid desaturation in red blood cell membranes of patients with type 2 diabetes is improved by zinc supplementation.,"BACKGROUND/OBJECTIVE


Membrane flexibility can be a determining factor in pathophysiological mechanisms of type 2 diabetes (T2D). As a cofactor of delta-5 desaturase (D5D) and delta-6 desaturase (D6D), and gene expression regulator, zinc may play a role modulating membrane flexibility by increasing membrane polyunsaturated fatty acids (PUFA) abundance. The objective of this study was to evaluate the effect of a 24-month zinc supplementation (30 mg elemental zinc) on membrane fatty acid composition in patients with T2D.
SUBJECTS/METHODS


Sixty patients with T2D were evaluated. Thirty were randomly assigned to the zinc supplemented group and thirty to the placebo group. Fatty acid composition in red blood cell (RBC) membranes was determined by gas chromatography. Expression of gene encoding for D5D (FADS1), and D6D (FADS2) were evaluated in peripheral blood mononuclear cells by real-time polymerase chain reaction.
RESULTS


After 24 months of supplementation, a greater abundance of docosapentaenoic acid (C22:5 n-3), arachidonic acid (C20:4 n-6), adrenic acid (C22:4 n-6), and total n-6 PUFA was found (p = 0.001, p = 0.007, p = 0.033, p = 0.048, respectively). The unsaturated fatty acids/saturated fatty acids ratio, and unsaturation index was increased in the zinc supplemented group at month 24 (p = 0.003 and p  = 0.000, respectively). FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020).
CONCLUSIONS


Supplementation with 30 mg/d elemental zinc during 24 months in patients with T2D had an effect on the composition of RBC membranes increasing PUFA abundance and in turn, improving membrane flexibility. This effect may be mediated by induction of D5D gene expression.",2020,"FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020).
","['patients with T2D', 'Sixty patients with T2D were evaluated', 'patients with type 2 diabetes']","['Fatty acid desaturation', 'zinc supplementation (30\u202fmg elemental zinc', 'placebo']","['membrane flexibility', 'Expression of gene encoding for D5D (FADS1), and D6D (FADS2', 'Fatty acid composition in red blood cell (RBC) membranes', 'abundance of docosapentaenoic acid (C22:5 n-3), arachidonic acid (C20:4 n-6), adrenic acid (C22:4 n-6), and total n-6 PUFA', 'FADS1 gene', 'unsaturated fatty acids/saturated fatty acids ratio, and unsaturation index', 'membrane fatty acid composition']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0057338', 'cui_str': 'delta-5 fatty acid desaturase'}, {'cui': 'C0065017', 'cui_str': 'Linoleoyl-CoA desaturase'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0058624', 'cui_str': 'docosapentaenoic acid'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0050877', 'cui_str': 'adrenic acid'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1276035', 'cui_str': 'Pena-Shokeir syndrome type I'}, {'cui': 'C0015690', 'cui_str': 'Unsaturated fatty acid'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",60.0,0.126956,"FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020).
","[{'ForeName': 'María Catalina', 'Initials': 'MC', 'LastName': 'Hernández', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Rojas', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Carrasco', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Basfi-Fer', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Valenzuela', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Juana', 'Initials': 'J', 'LastName': 'Codoceo', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Inostroza', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ruz', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile. Electronic address: mruz@med.uchile.cl.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126571']
2360,32538009,[Clinical observation of filiform fire needling on moderate and severe pain in advanced cancer].,"OBJECTIVE


To evaluate the clinical effect of filiform fire needling on moderate and severe pain in advanced cancer.
METHODS


A total of 66 patients with moderate and severe pain in advanced cancer were randomly divided into an observation group (34 cases, 4 cases dropped off) and a control group (32 cases, 2 cases dropped off). The two groups were treated with oral analgesics continuously for 4 weeks. The moderate pain patients was given bucinnazine hydrochloride tablets (starting at 30 mg, once every 6 hours, increasing by 30%-50% until the titration volume was reached), and the severe pain patients were given oxycodone hydrochloride sustained-release tablets (starting at 20 mg every 12 hours and increasing by 25%-50% until the titration volume was reached). The observation group was cooperated with filiform fire needling at  ashi  point, Zusanli (ST 36), Liangqiu (ST 34), Qihai (CV 6), Guanyuan(CV 4), Quchi (LI 11) and Waiguan (TE 5) once every other day for 4 weeks. The changes of numerical rating scales (NRS) scores were observed in both groups before and after treatment, and the amount of analgesics and the incidence of adverse reactions were recorded. The clinical effects in the two groups were evaluated.
RESULTS


The effective rate was 90.0% (27/30) in the observation group, which was higher than 66.7% (20/30) in the control group ( P <0.05). After treatment, the NRS scores of both groups were lower than those before treatment ( P <0.05), and the reducing degree in the observation group was larger than that in the control group ( P <0.05). The average dosage of bunarizine hydrochloride tablets and oxycodone hydrochloride sustained release tablets to titration volume in the observation group was less than that in the control group ( P <0.05). The incidence of adverse reactions was 23.3% (28/120) in the observation group, which was lower than 44.2% (53/120) in the control group ( P <0.05).
CONCLUSION


Filiform fire needling can alleviate pain symptoms of patients with moderate and severe pain in advanced cancer, reduce the amount of analgesics, and decrease the incidence of adverse reactions.",2020,"After treatment, the NRS scores of both groups were lower than those before treatment ( P <0.05), and the reducing degree in the observation group was larger than that in the control group ( P <0.05).","['66 patients with moderate and severe pain in advanced cancer', 'patients with moderate and severe pain in advanced cancer', 'advanced cancer']","['bunarizine hydrochloride tablets and oxycodone hydrochloride', 'Filiform fire needling', 'bucinnazine hydrochloride tablets', 'oxycodone hydrochloride sustained-release tablets', 'filiform fire needling', 'filiform fire needling at  ashi  point, Zusanli (ST 36), Liangqiu (ST 34), Qihai (CV 6), Guanyuan(CV 4), Quchi (LI 11) and Waiguan (TE 5']","['incidence of adverse reactions', 'moderate and severe pain', 'pain symptoms', 'adverse reactions', 'effective rate', 'NRS scores', 'numerical rating scales (NRS) scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0282274', 'cui_str': 'Oxycodone hydrochloride'}, {'cui': 'C0332226', 'cui_str': 'Filiform'}, {'cui': 'C0014007', 'cui_str': 'Dismissed from job'}, {'cui': 'C0950990', 'cui_str': '1-N-butyryl-4-cinnamylpiperazine hydrochloride'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0655714', 'cui_str': 'TE 5'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",66.0,0.0233146,"After treatment, the NRS scores of both groups were lower than those before treatment ( P <0.05), and the reducing degree in the observation group was larger than that in the control group ( P <0.05).","[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Graduate School of Nanjing University of Chinese Medicine, Nanjing 210046, Jiangsu Province, China.'}, {'ForeName': 'Shi-Nian', 'Initials': 'SN', 'LastName': 'Zhang', 'Affiliation': 'Massage Department of Jiangsu Provincial Hospital of TCM.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190531-k0001']
2361,32538010,[Efficacy and mechanism of acupuncture combined with  Tongxieyaofang  for diarrhea-type irritable bowel syndrome of liver depression and spleen deficiency].,"OBJECTIVE


To observe the clinical effect of acupuncture at lower- he  acupoints and front- mu  acupoints combined with  Tongxieyaofang  (TXYF) for diarrhea-type irritable bowel syndrome (IBS-D) of liver depression and spleen deficiency, and to explore its possible mechanism.
METHODS


A total of 123 IBS-D patients with syndrome of liver depression and spleen deficiency were randomly divided into an acupuncture+TXYF group, a TXYF group and a medication group, 41 cases in each group. The patients in TXYF group were treated with oral administration of TXYF, three times a day. The patients in acupuncture+TXYF group were treated with oral administration of TXYF and routine acupuncture at Shangjuxu (ST 37), Tianshu (ST 25), Taichong (LR 3), Sanyinjiao (SP 6) and Zusanli (ST 36), once a day. The patients in medication group were treated with oral administration of pinaverium bromide, 50 mg, three times a day. All the treatment was given for four weeks. The total score of TCM syndrome scale, self-rating anxiety scale (SAS), self-rating depression scale (SDS) scores as well as the expression of calcitonin gene-related peptide (CGRP), vasoactive peptide (VIP) and MAPK signal pathway indicators of ERK1 mRNA and ERK2 mRNA were compared before and after treatment; the clinical effect was also compared.
RESULTS


After treatment, the total score of TCM syndrome scale and SAS and SDS scores in each group were significantly reduced ( P <0.05), and the scores in the acupuncture+TXYF group were lower than those in TXYF group and medication group ( P <0.05). The total effective rate was 87.8% (36/41) in the acupuncture+TXYF group, which was higher than 78.0% (32/41) in the TXYF group and 68.3% (28/41) in the medication group ( P <0.05). After treatment, the levels of CGRP and VIP in each group were decreased ( P <0.05), and the levels in the acupuncture+TXYF group were lower than those in the TXYF group and the medication group ( P <0.05). After treatment, the levels of ERK1 mRNA and ERK2 mRNA in each group were decreased ( P <0.05), and the levels in acupuncture+TXYF group were lower than those in medication group ( P <0.05).
CONCLUSION


The acupuncture at lower- he  acupoints and front- mu  acupoints combined with TXYF could effectively alleviate the clinical symptoms, improve anxiety and depression in IBS-D patients with syndrome of liver depression and spleen deficiency, and its mechanism may be related to regulating the expression of ERK1 mRNA and ERK2 mRNA in MAPK signaling pathway, and reducing the serum levels of CGRP and VIP.",2020,"After treatment, the levels of CGRP and VIP in each group were decreased ( P <0.05), and the levels in the acupuncture+TXYF group were lower than those in the TXYF group and the medication group ( P <0.05).","['123 IBS-D patients with syndrome of liver depression and spleen deficiency', 'diarrhea-type irritable bowel syndrome of liver depression and spleen deficiency']","['acupuncture combined with  Tongxieyaofang', 'acupuncture at lower', 'acupuncture+TXYF', 'oral administration of TXYF and routine acupuncture at Shangjuxu (ST 37), Tianshu (ST 25), Taichong (LR 3), Sanyinjiao (SP 6) and Zusanli', 'oral administration of pinaverium bromide', 'TXYF', 'oral administration of TXYF', 'front- mu  acupoints combined with  Tongxieyaofang  (TXYF']","['total effective rate', 'total score of TCM syndrome scale and SAS and SDS scores', 'total score of TCM syndrome scale, self-rating anxiety scale (SAS), self-rating depression scale (SDS) scores as well as the expression of calcitonin gene-related peptide (CGRP), vasoactive peptide (VIP) and MAPK signal pathway indicators of ERK1 mRNA and ERK2 mRNA', 'levels of ERK1 mRNA and ERK2 mRNA', 'anxiety and depression', 'levels of CGRP and VIP']","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037993', 'cui_str': 'Splenic structure'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0001563', 'cui_str': 'Medication administration: oral'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C1813433', 'cui_str': 'ST-37'}, {'cui': 'C0626533', 'cui_str': 'SP 6'}, {'cui': 'C0137073', 'cui_str': 'Pinaverium bromide'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0006669', 'cui_str': 'Calcitonin gene-related peptide'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0752312', 'cui_str': 'Mitogen-Activated Protein Kinases'}, {'cui': 'C0037080', 'cui_str': 'Signal Pathways'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0082529', 'cui_str': 'Extracellular Signal-Regulated Kinase 1'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",123.0,0.0179067,"After treatment, the levels of CGRP and VIP in each group were decreased ( P <0.05), and the levels in the acupuncture+TXYF group were lower than those in the TXYF group and the medication group ( P <0.05).","[{'ForeName': 'Shan-Shan', 'Initials': 'SS', 'LastName': 'Wang', 'Affiliation': 'Proctology Department, Chongqing Hospital of TCM, Chongqing 400021, China.'}, {'ForeName': 'Xu-Rui', 'Initials': 'XR', 'LastName': 'Wang', 'Affiliation': ""Sichuan Academy of Medical Sciences•Proctology Department, Sichuan Provincial People's Hospital, Chengdu 610072; Affiliated Hospital of Chengdu University of TCM, Chengdu 610000, Sichuan Province.""}, {'ForeName': 'Rui-Yong', 'Initials': 'RY', 'LastName': 'Yang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Chongqing Jiangbei Hospital of TCM.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Proctology Department, Chongqing Hospital of TCM, Chongqing 400021, China.'}, {'ForeName': 'Ming-Yue', 'Initials': 'MY', 'LastName': 'Li', 'Affiliation': 'Affiliated Hospital of Chengdu University of TCM, Chengdu 610000, Sichuan Province.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190818-k0004']
2362,32538011,[Acupuncture at Ciliao (BL 32) for prevention of postpartum urinary retention in elderly parturient women: a randomized controlled trial].,"OBJECTIVE


To explore the preventive effect of acupuncture at Ciliao (BL 32) on postpartum urinary retention as well as the time and volume of the first urination after delivery in elderly parturient women undergoing vaginal delivery.
METHODS


A total of 180 elderly parturient women (≥35 years old) undergoing vaginal delivery were randomly divided into a blank control group, a conditional control group and an observation group, 60 cases in each group. The patients in the blank control group were treated with routine nursing plan; based on the treatment of the blank control group, the patients in the conditional control group were treated with additional intervention measures such as applying hot towel on the bladder and fingers pressing to stimulate urination; based on the treatment of the blank control group, the patients in the observation group were treated with acupuncture at bilateral Ciliao (BL 32) one hour after delivery for 20 min (the acupuncture was given only once). The incidence rate of postpartum urinary retention as well as the time and volume of the first urination among the women without urinary retention were observed; the satisfaction rate of the 3 groups was recorded.
RESULTS


The incidence rate of postpartum urinary retention in the observation group was 5.0% (3/60), which was significantly lower than 26.7% (16/60) in the blank control group ( P <0.01) and 16.7% (10/60) in the conditional control group ( P <0.05); the incidence rate of postpartum urinary retention in the conditional control group was significantly lower than that in the blank control group [16.7% (10/60) vs 26.7%(16/60),  P <0.05]. In the elderly women without urinary retention, the first urination time in the observation group was significantly earlier than that in the blank control group and conditional control group ( P <0.01), and the first urination time in the conditional control group was earlier than that in the blank control group ( P <0.01). The volume of first urination in the observation group was higher than that in the blank control group and the conditional control group ( P <0.05,  P <0.01). The satisfaction rates in the observation group and conditional control group were higher than that in the blank control group ( P <0.01).
CONCLUSION


Acupuncture at Ciliao (BL 32) could effectively prevent the postpartum urinary retention, improve the time and volume of the first urination in elderly parturient women undergoing vaginal delivery.",2020,"The volume of first urination in the observation group was higher than that in the blank control group and the conditional control group ( P <0.05,  P <0.01).","['elderly parturient women', '180 elderly parturient women (≥35 years old) undergoing vaginal delivery', 'elderly parturient women undergoing vaginal delivery']","['acupuncture at Ciliao (BL 32', 'acupuncture at bilateral Ciliao (BL 32) one hour after delivery for 20 min (the acupuncture', 'Acupuncture at Ciliao (BL 32', 'routine nursing plan', 'additional intervention measures such as applying hot towel on the bladder and fingers pressing to stimulate urination']","['first urination time', 'time and volume of the first urination', 'satisfaction rate', 'volume of first urination', 'satisfaction rates', 'postpartum urinary retention', 'incidence rate of postpartum urinary retention']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0336616', 'cui_str': 'Towel'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}]","[{'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",180.0,0.0181422,"The volume of first urination in the observation group was higher than that in the blank control group and the conditional control group ( P <0.05,  P <0.01).","[{'ForeName': 'Shao-Fei', 'Initials': 'SF', 'LastName': 'Gu', 'Affiliation': 'Department of TCM, First Affiliated Hospital of Wannan Medical College, Wuhu 241000, Anhui Province, China.'}, {'ForeName': 'Ming-Qiang', 'Initials': 'MQ', 'LastName': 'Li', 'Affiliation': 'Department of TCM, First Affiliated Hospital of Wannan Medical College, Wuhu 241000, Anhui Province, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of TCM, First Affiliated Hospital of Wannan Medical College, Wuhu 241000, Anhui Province, China.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'No. 31 Inpatient Ward, First Affiliated Hospital of Wannan Medical College, Wuhu 241000, Anhui Province, China.'}, {'ForeName': 'Ling-Li', 'Initials': 'LL', 'LastName': 'Han', 'Affiliation': 'Department of Gynecology and Obstetrics, First Affiliated Hospital of Wannan Medical College, Wuhu 241000, Anhui Province, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190528-k0005']
2363,32538012,[Effect of transcutaneous electrical acupoint stimulation on labor analgesia].,"OBJECTIVE


To observe the effect of transcutaneous electrical acupoint stimulation (TEAS) on labor pain.
METHODS


A total of 151 primiparas who were vaginal delivery were randomized into a TEAS group (76 cases) and a peridural group (75 cases). In the peridural group, peridural blockage was applied to analgesia. In the TEAS group, TEAS was applied at Hegu (LI 4)，Neiguan (PC 6), Jiaji T 10 ~L 1  (EX-B 2) and Ciliao (BL 32), disperse-dense wave (2 Hz/100 Hz), 15-50 mA in current intensity. The analgesic time was from 3 cm to completely opening of cervix. The visual analogue scale (VAS) scores were observed before analgesia, after 30, 60, 120 min of analgesia in the two groups. The time of different stages of labor, usage rate of oxytocin, incidence rate of adverse reaction and amount of postpartum hemorrhage were recorded. The newborn's 1 and 5 min Apgar scores were evaluated.
RESULTS


The VAS scores showed a downward trend in the two groups after analgesia ( P <0.01), and the change of the TEAS group was less than the peridural group ( P <0.01). The active phase on the first stage and second stage of labor in the TEAS group were shorter than the peridural group ( P <0.01,  P <0.05), there was no significant difference in the time of third stage of labor between the two groups ( P >0.05). The usage rate of oxytocin and incidence rate of adverse reaction in the TEAS group were 9.2% (7/76) and 2.6% (2/76), which were lower than 34.7% (26/75) and 18.7% (14/75) in the peridural group ( P <0.01). There was no significant difference in the amount of postpartum hemorrhage and newborn's 1 and 5 min Apgar scores between the two groups ( P >0.05).
CONCLUSION


The analgesic effect of TEAS is inferior to peridural blockage, but TEAS could relieve labor pain to the tolerance, shorten the time of active phase on the first stage and second stage of labor and reduce the use of oxytocin, has mild adverse reaction.",2020,"There was no significant difference in the amount of postpartum hemorrhage and newborn's 1 and 5 min Apgar scores between the two groups ( P >0.05).
",['151 primiparas who were vaginal delivery'],"['TEAS', 'oxytocin', 'transcutaneous electrical acupoint stimulation', 'transcutaneous electrical acupoint stimulation (TEAS']","[""newborn's 1 and 5 min Apgar scores"", 'Jiaji T 10 ~L 1  (EX-B 2) and Ciliao (BL 32', 'visual analogue scale (VAS) scores', 'analgesic time', 'labor analgesia', 'time of third stage of labor', ""amount of postpartum hemorrhage and newborn's 1 and 5 min Apgar scores"", 'labor pain', 'usage rate of oxytocin and incidence rate of adverse reaction', 'time of different stages of labor, usage rate of oxytocin, incidence rate of adverse reaction and amount of postpartum hemorrhage', 'VAS scores']","[{'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0045550', 'cui_str': '2,5-dichloro-4-bromophenol'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1301740', 'cui_str': 'Analgesia in labor'}, {'cui': 'C0022873', 'cui_str': 'Third stage of labor'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0474368', 'cui_str': 'Labor pain'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",151.0,0.0337001,"There was no significant difference in the amount of postpartum hemorrhage and newborn's 1 and 5 min Apgar scores between the two groups ( P >0.05).
","[{'ForeName': 'Wei-Juan', 'Initials': 'WJ', 'LastName': 'Miao', 'Affiliation': ""Department of Obstetrics, Affiliated Hospital of Qingdao University, Qingdao 266000, Shandong Province, China; Department of Obstetrics, People's Hospital of Rizhao, Rizhao 276800, Shandong Province.""}, {'ForeName': 'Wei-Hong', 'Initials': 'WH', 'LastName': 'Qi', 'Affiliation': 'Department of Obstetrics, Affiliated Hospital of Qingdao University, Qingdao 266000, Shandong Province, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Department of Obstetrics, People's Hospital of Rizhao, Rizhao 276800, Shandong Province.""}, {'ForeName': 'Xiang-Lan', 'Initials': 'XL', 'LastName': 'Song', 'Affiliation': ""Department of Obstetrics, People's Hospital of Rizhao, Rizhao 276800, Shandong Province.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Obstetrics, People's Hospital of Rizhao, Rizhao 276800, Shandong Province.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': ""Department of Obstetrics, People's Hospital of Rizhao, Rizhao 276800, Shandong Province.""}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190824-0001']
2364,32536853,Physical Exercise May Increase Plasma Concentration of High-Density Lipoprotein-Cholesterol in Patients With Alzheimer's Disease.,"Lifestyle factors have been shown to increase the risk of developing Alzheimer's disease (AD) later in life. Specifically, an unfavorable cholesterol profile, and insulin resistance are associated with increased risk of developing AD. One way to non-pharmacologically affect the levels of plasma lipids is by exercise, which has been shown to be beneficial in cognitively healthy individuals. In this randomized controlled trial y, we therefore aimed to clarify the effect of physical exercise on the lipid profile, insulin and glucose in patients with AD. In addition, we investigated the effect of apolipoproteinE genotype on total cholesterol, high-density lipoprotein-cholesterol (HDL-C), low-density lipoprotein-cholesterol (LDL-C), and triglycerides (TG) in plasma from patients with AD. Plasma samples from 172 patients who underwent 16 weeks of moderate-to-high intensity exercise ( n  = 90) or treatment as usual ( n  = 82) were analyzed change from baseline for the levels of total cholesterol, LDL-C, HDL-C, TG, glucose, and insulin. In addition, we analyzed those from the exercise group who adhered to the protocol with an attendance of 2/3 or more of the exercise session and who followed the protocol of an intensity of 70% of the maximum heart rate. We found a significant increase in plasma HDL-C levels between the ""high exercise sub-group"" compared to control group. After intervention HDL-C was increased by 4.3% in the high-exercise group, and decreased by 0.7% in the control group, after adjustment for statin use. In conclusion, short term physical activity may be beneficial on the cholesterol profile in patients with AD.",2020,"We found a significant increase in plasma HDL-C levels between the ""high exercise sub-group"" compared to control group.","['patients with AD', ""Patients With Alzheimer's Disease"", '172 patients who underwent 16 weeks of moderate-to-high intensity exercise ( n  = 90) or treatment as usual ( n  = 82', 'cognitively healthy individuals']","['Physical Exercise', 'physical exercise']","['total cholesterol, LDL-C, HDL-C, TG, glucose, and insulin', 'unfavorable cholesterol profile, and insulin resistance', 'plasma HDL-C levels', 'total cholesterol, high-density lipoprotein-cholesterol (HDL-C), low-density lipoprotein-cholesterol (LDL-C), and triglycerides (TG', 'lipid profile, insulin and glucose']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}]",172.0,0.064628,"We found a significant increase in plasma HDL-C levels between the ""high exercise sub-group"" compared to control group.","[{'ForeName': 'Camilla Steen', 'Initials': 'CS', 'LastName': 'Jensen', 'Affiliation': 'Danish Dementia Research Centre, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Christian Sandøe', 'Initials': 'CS', 'LastName': 'Musaeus', 'Affiliation': 'Danish Dementia Research Centre, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Frikke-Schmidt', 'Affiliation': 'Department of Clinical Biochemistry, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Birgitte Bo', 'Initials': 'BB', 'LastName': 'Andersen', 'Affiliation': 'Danish Dementia Research Centre, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Beyer', 'Affiliation': 'Department of Physical and Occupational Therapy, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Gottrup', 'Affiliation': 'Dementia Clinic, Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Høgh', 'Affiliation': 'Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Vestergaard', 'Affiliation': 'Dementia Clinic, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Wermuth', 'Affiliation': 'Dementia Clinic, Department of Neurology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Kristian Steen', 'Initials': 'KS', 'LastName': 'Frederiksen', 'Affiliation': 'Danish Dementia Research Centre, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Gunhild', 'Initials': 'G', 'LastName': 'Waldemar', 'Affiliation': 'Danish Dementia Research Centre, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Steen', 'Initials': 'S', 'LastName': 'Hasselbalch', 'Affiliation': 'Danish Dementia Research Centre, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Anja Hviid', 'Initials': 'AH', 'LastName': 'Simonsen', 'Affiliation': 'Danish Dementia Research Centre, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}]",Frontiers in neuroscience,['10.3389/fnins.2020.00532']
2365,32536880,Reducing Risky Alcohol Use  via  Smartphone App Skills Training Among Adult Internet Help-Seekers: A Randomized Pilot Trial.,"Alcohol is one of the leading risk factors for global disease burden and overconsumption leads to a wide variety of negative consequences in everyday life. Digital interventions have shown small positive effects in contributing to reductions in problematic use. Specific research on smartphone apps is sparse and the few studies published indicate effects ranging from negative or null to small or moderate. TeleCoach™, a web-based skills training smartphone app, has shown positive effects in non-treatment-seeking university students with excessive drinking. This pilot trial aimed to evaluate app effects in a sample of internet help-seekers from the general population in Sweden. A total of 89 participants were recruited  via  online advertisement. Following baseline assessment for hazardous use, they were randomized to TeleCoach or a web-based control app offering brief information and advice regarding problematic alcohol use. The primary outcome was number of standard drinks per week; secondary outcomes included drinking quantity and frequency, binge drinking and blood alcohol count measures as well as app user data and comorbidity related to depression, anxiety, and drug use. Analysis of baseline and 6-week follow-up outcomes showed significant within-group effects on alcohol consumption but no significant between-group differences. Effect sizes for the within-group changes in the primary outcome over time were significant [ F (1, 55)=43.98; p < 0.001], with a Cohen's  d  of 1.37 for the intervention group and 0.92 for the control group. This difference in effect sizes indicated that continuation of the study as a large randomized, controlled trial with up to 1,000 participants could be worthwhile.
Clinical Trial Registration


www.ClinicalTrials.gov, identifier NCT03696888.",2020,"TeleCoach™, a web-based skills training smartphone app, has shown positive effects in non-treatment-seeking university students with excessive drinking.","['1,000 participants could be worthwhile', 'Adult Internet Help-Seekers', 'general population in Sweden', 'non-treatment-seeking university students with excessive drinking', '89 participants were recruited  via  online advertisement']","['TeleCoach', 'Risky Alcohol Use  via  Smartphone App Skills Training']","['alcohol consumption', 'number of standard drinks per week; secondary outcomes included drinking quantity and frequency, binge drinking and blood alcohol count measures as well as app user data and comorbidity related to depression, anxiety, and drug use']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0683357', 'cui_str': 'Excessive drinking'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C1167994', 'cui_str': 'Blood alcohol'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}]",89.0,0.152833,"TeleCoach™, a web-based skills training smartphone app, has shown positive effects in non-treatment-seeking university students with excessive drinking.","[{'ForeName': 'Anne H', 'Initials': 'AH', 'LastName': 'Berman', 'Affiliation': 'Center for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Molander', 'Affiliation': 'Center for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Miran', 'Initials': 'M', 'LastName': 'Tahir', 'Affiliation': 'Division of Psychology, Dept of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Törnblom', 'Affiliation': 'Division of Psychology, Dept of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Gajecki', 'Affiliation': 'Center for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Sinadinovic', 'Affiliation': 'Center for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Claes', 'Initials': 'C', 'LastName': 'Andersson', 'Affiliation': 'Department of Criminology, Malmö University, Malmö, Sweden.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00434']
2366,32536887,Peer Actors and Theater Techniques Play Pivotal Roles in Improving Social Play and Anxiety for Children With Autism.,"Children with autism spectrum disorder (ASD) have significant difficulty in social functioning to include engaging in natural play with peers. Many children with ASD exhibit significantly less interactive play and more physiological stress during benign social encounters with same-age peers on a playground. Theatrical role-playing and performance with expert role models may provide a unique opportunity for children with ASD to learn to engage with other children in a safe, supportive environment. SENSE Theatre ®  is a peer-mediated, theater-based program aimed at improving social competence in youth with ASD. Previous studies have shown significant improvements in social and communication skills following SENSE Theatre ®  intervention. The current project examined play with novel peers and self-reported anxiety before and after participation in SENSE Theatre ® . Participants included 77 children between 8 and 16 years with high-functioning (IQ ≥ 70) ASD. The combined sample of three cohorts was randomized to the experimental (EXP,  N  = 44) or waitlist control (WLC,  N  = 33) group. Participants in the EXP group received 40 h (10, 4-h sessions) of SENSE Theatre ® . The Peer Interaction Paradigm (PIP), an ecologically valid measure of natural play, was administered before and after the intervention. Group Play and Self Play on the playground equipment during solicited (T4) and unsolicited (T1) play were used in the current study. The State Trait Anxiety Scale for Children (STAIC; Spielberger et al., 1983) was used to measure self-reported current and persistent anxiety, respectively. Following treatment, children in the EXP group engaged in significantly more Group Play with novel peers [ F (2,73) = 7.78,  p  = 0.007] and much less Self Play [ F (2,73) = 6.70,  p  = 0.01] during solicited play compared to the WLC group. Regression analysis revealed that pretreatment play and group status were significant predictors of solicited Group Play. Children in the EXP group reported significantly less Trait anxiety following intervention [ F (2,71) = 6.87,  p  = 0.01]; however, State anxiety was comparable. Results corroborate previous findings of significant changes in social and play behavior in children with ASD following the peer-mediated, theater-based intervention. Acting and theatrical performance with supportive role models facilitates social engagement in everyday settings with novel peers and reductions in self-reported anxiety.",2020,"SENSE Theatre ®  is a peer-mediated, theater-based program aimed at improving social competence in youth with ASD.","['children with ASD', 'youth with ASD', 'Children With Autism', 'Participants included 77 children between 8 and 16 years with high-functioning (IQ ≥ 70) ASD', 'Children with autism spectrum disorder (ASD']","['waitlist control (WLC,  N  = 33) group']","['physiological stress', 'State anxiety', 'State Trait Anxiety Scale', 'Trait anxiety', 'social and communication skills', 'social and play behavior']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0449430', 'cui_str': 'Physiological stress'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0518192', 'cui_str': 'Play behavior'}]",77.0,0.0214202,"SENSE Theatre ®  is a peer-mediated, theater-based program aimed at improving social competence in youth with ASD.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ioannou', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Vanderbilt University Medical Center, Nashville, TN, United States.'}, {'ForeName': 'Alexandra P', 'Initials': 'AP', 'LastName': 'Key', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Vanderbilt University Medical Center, Nashville, TN, United States.'}, {'ForeName': 'Rachael A', 'Initials': 'RA', 'LastName': 'Muscatello', 'Affiliation': 'Vanderbilt Brain Institute, Vanderbilt University, Nashville, TN, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Klemencic', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Vanderbilt University Medical Center, Nashville, TN, United States.'}, {'ForeName': 'Blythe A', 'Initials': 'BA', 'LastName': 'Corbett', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Vanderbilt University Medical Center, Nashville, TN, United States.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.00908']
2367,32536891,Exploring Changes in Event-Related Potentials After a Feasibility Trial of Inhibitory Training for Bulimia Nervosa and Binge Eating Disorder.,"In a feasibility trial comparing two forms of combined inhibitory control training and goal planning (i.e., food-specific and general) among patients with bulimia nervosa (BN) and binge eating disorder (BED), we found evidence of symptomatic benefit, with stronger effects among participants receiving a food-specific intervention. The aim of the present study was to examine changes in behavioral outcomes and event-related potentials (ERPs; N2 and P3 amplitudes) from baseline to post-intervention that might suggest the mechanisms underpinning these effects. Fifty-five participants completed go/no-go tasks during two electroencephalography (EEG) sessions, at baseline and post-intervention. The go/no-go task included ""go"" cues to low energy-dense foods and non-foods, and ""no-go"" cues to high energy-dense foods and non-foods. Datasets with poor signal quality and/or outliers were excluded, leaving 48 participants ( N  = 24 BN;  N  = 24 BED) in the analyses. Participants allocated to the food-specific, compared to the general intervention group, showed significantly greater reductions in reaction time to low energy-dense foods, compared to non-foods, by post-intervention. Commission errors significantly increased from baseline to post-intervention, regardless of stimulus type (food vs. non-food) and intervention group (food-specific vs. general). There were no significant changes in omission errors. P3 amplitudes to ""no-go"" cues marginally, but non-significantly, decreased by post-intervention, but there was no significant interaction with stimulus type (high energy-dense food vs. non-food) or intervention group (food-specific vs. general). There were no significant changes in N2 amplitudes to ""no-go"" cues, N2 amplitudes to ""go"" cues, or P3 amplitudes to ""go"" cues from baseline to post-intervention. Training effects were only marginally captured by these event-related potentials. We discuss limitations to the task paradigm, including its two-choice nature, ease of completion, and validity, and give recommendations for future research exploring ERPs using inhibitory control paradigms.",2020,"There were no significant changes in N2 amplitudes to ""no-go"" cues, N2 amplitudes to ""go"" cues, or P3 amplitudes to ""go"" cues from baseline to post-intervention.","['Bulimia Nervosa and Binge Eating Disorder', 'Fifty-five participants completed go/no-go tasks during two electroencephalography (EEG) sessions, at baseline and post-intervention', 'participants receiving a food-specific intervention', 'patients with bulimia nervosa (BN) and binge eating disorder (BED']","['Inhibitory Training', 'combined inhibitory control training and goal planning (i.e., food-specific and general', 'go"" cues to low energy-dense foods and non-foods, and ""no-go"" cues to high energy-dense foods and non-foods']","['reaction time', 'behavioral outcomes and event-related potentials (ERPs; N2 and P3 amplitudes', 'omission errors', 'P3 amplitudes to ""no-go"" cues', 'Commission errors', 'N2 amplitudes to ""no-go"" cues, N2 amplitudes to ""go"" cues, or P3 amplitudes to ""go"" cues']","[{'cui': 'C2267227', 'cui_str': 'Bulimia nervosa'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0453831', 'cui_str': 'High energy food'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282171', 'cui_str': 'Event-related potentials'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]",55.0,0.0436407,"There were no significant changes in N2 amplitudes to ""no-go"" cues, N2 amplitudes to ""go"" cues, or P3 amplitudes to ""go"" cues from baseline to post-intervention.","[{'ForeName': 'Rayane', 'Initials': 'R', 'LastName': 'Chami', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, King's College London, London, United Kingdom.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Treasure', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, King's College London, London, United Kingdom.""}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Cardi', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, King's College London, London, United Kingdom.""}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Lozano-Madrid', 'Affiliation': ""Department of Psychiatry, Bellvitge University Hospital-Institut d'Investigacio Biomedica de Bellvitge (IDIBELL), Barcelona, Spain.""}, {'ForeName': 'Katharina Naomi', 'Initials': 'KN', 'LastName': 'Eichin', 'Affiliation': 'Department of Psychology, Centre for Cognitive Neuroscience, Paris-Lodron-University of Salzburg, Salzburg, Austria.'}, {'ForeName': 'Grainne', 'Initials': 'G', 'LastName': 'McLoughlin', 'Affiliation': ""Social, Genetic, and Developmental Psychiatry Department, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Blechert', 'Affiliation': 'Department of Psychology, Centre for Cognitive Neuroscience, Paris-Lodron-University of Salzburg, Salzburg, Austria.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.01056']
2368,32537126,Pressure pain threshold and temporal summation in adults with episodic and persistent low back pain trajectories: a secondary analysis at baseline and after lumbar manipulation or sham.,"Background


People with chronic low back pain (LBP) typically have increased pain sensitivity compared to healthy controls, however its unknown if pain sensitivity differs based on LBP trajectory at baseline or after manual therapy interventions. We aimed to compare baseline pressure pain threshold (PPT) and temporal summation (TS) between people without LBP, with episodic LBP, and with persistent LBP, and to compare changes over time in PPT and TS after a lumbar spinal manipulation or sham manipulation in those with LBP.
Methods


Participants were aged 18-59, with or without LBP. Those with LBP were categorised as having either episodic or persistent LBP. PPT and TS were tested at baseline. LBP participants then received a lumbar spinal manipulation or sham, after which PPT and TS were re-tested three times over 30 min. Generalised linear mixed models were used to analyse data.
Results


One hundred participants (49 female) were included and analysed. There were 20 non-LBP participants (mean age 31 yrs), 23 episodic LBP (mean age 35 yrs), and 57 persistent LBP (mean age 37 yrs). There were no significant differences in PPT or TS between groups at baseline. There was a non-significant pattern of lower PPT (higher sensitivity) from the non-LBP group to the persistent LBP group at baseline, and high variability. Changes in PPT and TS after the interventions did not differ between the two LBP groups.
Discussion


We found no differences between people with no LBP, episodic LBP, or persistent LBP in baseline PPT or TS. Changes in PPT and TS following a lumbar manual therapy intervention do not appear to differ between LBP trajectories.
Trial registration


The trial was prospectively registered with ANZCTR (ACTRN12617001094369).",2020,"There was a non-significant pattern of lower PPT (higher sensitivity) from the non-LBP group to the persistent LBP group at baseline, and high variability.","['people without LBP, with episodic LBP, and with persistent LBP', 'One hundred participants (49 female) were included and analysed', 'adults with episodic and persistent low back pain trajectories', '20 non-LBP participants (mean age 31\u2009yrs), 23 episodic LBP (mean age 35\u2009yrs), and 57 persistent LBP (mean age 37\u2009yrs', 'Methods\n\n\nParticipants were aged 18-59, with or without LBP', '\n\n\nPeople with chronic low back pain (LBP']","['LBP', 'lumbar spinal manipulation']","['PPT or TS', 'pain sensitivity', 'Pressure pain threshold and temporal summation', 'baseline pressure pain threshold (PPT) and temporal summation (TS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0086586', 'cui_str': 'Manipulation of spine'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation'}, {'cui': 'C0443150', 'cui_str': 'Baseline pressure'}]",100.0,0.151039,"There was a non-significant pattern of lower PPT (higher sensitivity) from the non-LBP group to the persistent LBP group at baseline, and high variability.","[{'ForeName': 'Sasha L', 'Initials': 'SL', 'LastName': 'Aspinall', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, 90 South St, Murdoch, WA 6150 Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Jacques', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, 90 South St, Murdoch, WA 6150 Australia.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Leboeuf-Yde', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, 90 South St, Murdoch, WA 6150 Australia.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Etherington', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, 90 South St, Murdoch, WA 6150 Australia.'}, {'ForeName': 'Bruce F', 'Initials': 'BF', 'LastName': 'Walker', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, 90 South St, Murdoch, WA 6150 Australia.'}]",Chiropractic & manual therapies,['10.1186/s12998-020-00326-5']
2369,32528654,Learning to make informed health choices: Protocol for a pilot study in schools in Barcelona.,"Introduction:  The Informed Health Choices (IHC) project has developed learning resources to teach primary school children (10 to 12-year-olds) to assess treatment claims and make informed health choices. The aim of our study is to explore both the students' and teachers' experience when using these resources in the context of Barcelona (Spain).  Methods:  During the 2019-2020 school year, we will conduct a pilot study with 4  th  and 5  th -year primary school students (9 to 11-year-olds) from three schools in Barcelona. The intervention in the schools will include: 1) assessment of the IHC resources by the teachers before the lessons, 2) non-participatory observations during the lessons, 3) semi-structured interviews with the students after a lesson, 4) assessment of the lessons by the teachers after a lesson, 5) treatment claim assessment by the students at the end of the lessons, and 6) assessment of the IHC resources by the teachers at the end of the lessons. We will use  ad hoc  questionnaires and guides to register the data. We will perform a quantitative and qualitative analysis of the data to explore understandability, desirability, suitability, usefulness, facilitators and barriers of the resources. The most relevant results will be discussed and some recommendations on how to use, how to adapt (if needed), and how to implement the IHC resources to this context will be agreed. The findings of the contextualization activities could inform the design of a cluster-randomised trial, to determine the effectiveness of the IHC resources in this context prior to scaling-up its use.  Ethical considerations:  The study protocol has obtained an approval exemption from the Ethics Committee of the Hospital de la Santa Creu i Sant Pau (Barcelona, Spain).",2019,"The findings of the contextualization activities could inform the design of a cluster-randomised trial, to determine the effectiveness of the IHC resources in this context prior to scaling-up its use.  ","['schools in Barcelona', 'primary school children (10 to 12-year-olds', 'During the 2019-2020 school year, we will conduct a pilot study with 4  th  and 5  th -year primary school students (9 to 11-year-olds) from three schools in Barcelona']","['IHC resources by the teachers before the lessons, 2) non-participatory observations during the lessons, 3) semi-structured interviews with the students after a lesson, 4) assessment of the lessons by the teachers after a lesson, 5) treatment claim assessment', 'Santa Creu']",[],"[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],,0.0303023,"The findings of the contextualization activities could inform the design of a cluster-randomised trial, to determine the effectiveness of the IHC resources in this context prior to scaling-up its use.  ","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Martínez García', 'Affiliation': 'Iberoamerican Cochrane Centre (IbCC) - Sant Pau Biomedical Research Institute (IIB-Sant Pau), Barcelona, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Alonso-Coello', 'Affiliation': 'Iberoamerican Cochrane Centre (IbCC) - Sant Pau Biomedical Research Institute (IIB-Sant Pau), Barcelona, Spain.'}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Asso Ministral', 'Affiliation': 'Maternal and Child Health Service, General Subdirectorate of Health Promotion, Public Health Agency of Catalonia, Barcelona, Spain.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Ballesté-Delpierre', 'Affiliation': 'ISGlobal, Hospital Clínic, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Canelo Aybar', 'Affiliation': 'Iberoamerican Cochrane Centre (IbCC) - Sant Pau Biomedical Research Institute (IIB-Sant Pau), Barcelona, Spain.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'de Britos', 'Affiliation': 'Escola Virolai, Barcelona, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Fernández Rodríguez', 'Affiliation': 'Escola Sant Martí, Barcelona, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Gallego Iborra', 'Affiliation': 'Andalusian Health Service, Malaga, Spain.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Leo Rosas', 'Affiliation': 'Iberoamerican Cochrane Centre (IbCC) - Sant Pau Biomedical Research Institute (IIB-Sant Pau), Barcelona, Spain.'}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'Llaquet', 'Affiliation': 'Escola Virolai, Barcelona, Spain.'}, {'ForeName': 'Ena Pery', 'Initials': 'EP', 'LastName': 'Niño de Guzmán Quispe', 'Affiliation': 'Iberoamerican Cochrane Centre (IbCC) - Sant Pau Biomedical Research Institute (IIB-Sant Pau), Barcelona, Spain.'}, {'ForeName': 'Giordano', 'Initials': 'G', 'LastName': 'Pérez-Gaxiola', 'Affiliation': 'Paediatric Hospital of Sinaloa, Sinaloa, Mexico.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Requeijo', 'Affiliation': 'Epidemiology and Public Health Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Salas-Gama', 'Affiliation': 'Epidemiology and Public Health Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Samsó Jofra', 'Affiliation': 'Epidemiology and Public Health Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Terres', 'Affiliation': 'Institut Escola Antaviana, Barcelona, Spain.'}, {'ForeName': 'Iratxe', 'Initials': 'I', 'LastName': 'Urreta', 'Affiliation': 'Clinical Epidemiology and Research Unit, University Hospital of Donostia, Donostia, Spain.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Rosenbaum', 'Affiliation': 'Centre for Informed Health Choices, Norwegian Institute of Public Health, Oslo, Norway.'}]",F1000Research,['10.12688/f1000research.21292.2']
2370,32537238,Contingency management for smoking cessation among individuals with type 2 diabetes: protocol for a multi-center randomized controlled feasibility trial.,"Background


Individuals with type 2 diabetes (T2D) who smoke are at increased risk for many types of cancers as well as an accelerated progression of microvascular and macrovascular complications. Smoking cessation is recommended as a standard treatment for T2D; however, individuals with T2D are faced with competing lifestyle changes. Glycemic and blood pressure control often take precedence over smoking cessation, and patients are often unmotivated to quit. Contingency management in combination with standard smoking cessation treatment has been demonstrated to improve cessation outcomes in various populations. The purpose of this randomized controlled feasibility trial is to explore the feasibility of contingency management and biochemical verification using a remote smartphone-based carbon monoxide monitor for smoking cessation among individuals with T2D.
Methods


A three-arm, randomized controlled feasibility trial will be conducted in two study sites that include the USA and UK. We will recruit 60 participants who will each receive usual care smoking cessation treatment (counseling and nicotine replacement therapy) and be randomized to a short term incentives (6 weeks), long term incentives (12 weeks), or no incentives (control) group. Participants will receive a smartphone and carbon monoxide monitor to complete daily remote assessments throughout the 12 weeks and will complete an exit interview at the end of the study. The primary outcomes for this feasibility study include completion of the protocol and proportion of daily assessments completed. Secondary outcomes include recruitment measures, acceptability, and smoking abstinence.
Discussion


We will explore the feasibility of recruiting smokers with T2D and their engagement in the program, particularly related to the use of the remote biochemical verification and smartphone application. In addition, we will evaluate the intervention content, study procedures, data collection methods, and follow-up and will qualitatively assess the participants' acceptability of the program. The results of this study will inform the design of a larger trial to test the efficacy of the contingency management program for improving smoking cessation outcomes among individuals with T2D.
Trial registration


This randomized controlled feasibility trial has been registered at ClinicalTrials.gov with an ID NCT03527667 on May 4, 2018.",2020,"The purpose of this randomized controlled feasibility trial is to explore the feasibility of contingency management and biochemical verification using a remote smartphone-based carbon monoxide monitor for smoking cessation among individuals with T2D.
Methods


A three-arm, randomized controlled feasibility trial will be conducted in two study sites that include the USA and UK.","['individuals with T2D', '60 participants who will each receive', 'individuals with T2D.\nMethods', 'individuals with type 2 diabetes']","['smartphone and carbon monoxide monitor', 'Contingency management', 'usual care smoking cessation treatment (counseling and nicotine replacement therapy', 'remote smartphone-based carbon monoxide monitor', 'contingency management program', 'short term incentives (6\u2009weeks), long term incentives (12\u2009weeks), or no incentives (control) group']","['Glycemic and blood pressure control', 'smoking cessation outcomes', 'completion of the protocol and proportion of daily assessments completed', 'recruitment measures, acceptability, and smoking abstinence']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0221822', 'cui_str': 'Carbon monoxide compressed air/gas monitor'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]",60.0,0.0759145,"The purpose of this randomized controlled feasibility trial is to explore the feasibility of contingency management and biochemical verification using a remote smartphone-based carbon monoxide monitor for smoking cessation among individuals with T2D.
Methods


A three-arm, randomized controlled feasibility trial will be conducted in two study sites that include the USA and UK.","[{'ForeName': 'Sydney A', 'Initials': 'SA', 'LastName': 'Martinez', 'Affiliation': 'Department of Biostatistics and Epidemiology, Hudson College of Public Health, University of Oklahoma Health Sciences Center, 801 NE 13th Street, Oklahoma City, OK 73104 USA.'}, {'ForeName': 'Samantha L', 'Initials': 'SL', 'LastName': 'Quaife', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, Gower Street, London, WC1E 6BT UK.'}, {'ForeName': 'Afsheen', 'Initials': 'A', 'LastName': 'Hasan', 'Affiliation': 'Department of Biostatistics and Epidemiology, Hudson College of Public Health, University of Oklahoma Health Sciences Center, 801 NE 13th Street, Oklahoma City, OK 73104 USA.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'McMillan', 'Affiliation': 'Digital Health and Wellness Group, Computer and Information Sciences, University of Strathclyde, Livingstone Tower Building, Glasgow, G1 1QE UK.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Beebe', 'Affiliation': 'Department of Biostatistics and Epidemiology, Hudson College of Public Health, University of Oklahoma Health Sciences Center, 801 NE 13th Street, Oklahoma City, OK 73104 USA.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Muirhead', 'Affiliation': 'Physical Activity for Health, School of Psychological Sciences and Health, University of Strathclyde, Graham Hills Building, 50 George Street, Glasgow, G1 1QE UK.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00629-7']
2371,31267524,Diagnosis of intravascular large B cell lymphoma: novel insights into clinicopathological features from 42 patients at a single institution over 20 years.,"This study aimed to clarify the comprehensive clinical, laboratory, pathological and imaging features of intravascular large B-cell lymphoma (IVLBCL) using data on 42 IVLBCL patients diagnosed at our hospital over the past 20 years. The majority of patients were diagnosed via random skin biopsy (29/42, 69·0%) followed by bone marrow biopsy alone (8/42, 19·0%). Characteristic features included persistent fever (41/42, 97·6%), decreased performance status (≥2) (100%), hypoxaemia (32/40, 80·0%), impaired consciousness (19/42, 45·2%), hypoalbuminemia (42/42, 100%) and extreme elevation of lactate dehydrogenase and soluble interleukin 2 receptor levels. Brain magnetic resonance imaging showed abnormal findings in 32/37 patients (86·4%). Hyperintense lesion in the pons was a peculiar finding that was unrelated to the neurological deficits. Positron emission tomography-computed tomography revealed a high incidence of bone marrow (26/34, 76·5%), spleen (19/34, 55·9%) and adrenal gland (9/34, 26·5%) involvement. Neurolymphomatosis was noted in 6 patients during the course of the disease. About 60% of IVLBCL patients in whom in vivo diagnosis was possible survived more than 5 years with combination chemotherapy. Our observations provide additional insight into the diagnosis of IVLBCL and indicate that early disease recognition via random skin biopsy combined with imaging, enables in vivo diagnosis of the disease and improved survival for many patients.",2019,"Positron emission tomography-computed tomography revealed a high incidence of bone marrow (26/34, 76·5%), spleen (19/34, 55·9%) and adrenal gland (9/34, 26·5%) involvement.","['42 patients at a single institution over 20\xa0years', '42 IVLBCL patients diagnosed at our hospital over the past 20\xa0years', '32/37 patients (86·4']","['Positron emission tomography-computed tomography', 'IVLBCL', 'bone marrow biopsy alone']","['Neurolymphomatosis', 'persistent fever', 'impaired consciousness', 'extreme elevation of lactate dehydrogenase and soluble interleukin 2 receptor levels', 'hypoxaemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0334660', 'cui_str': 'Angioendotheliomatosis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205136', 'cui_str': 'Over'}]","[{'cui': 'C1699633', 'cui_str': 'Positron emission tomography with computed tomography'}, {'cui': 'C0334660', 'cui_str': 'Angioendotheliomatosis'}, {'cui': 'C0005954', 'cui_str': 'Bone marrow sampling'}]","[{'cui': 'C0024793', 'cui_str': ""Marek's Disease""}, {'cui': 'C0476474', 'cui_str': 'Persistent fever'}, {'cui': 'C0234428', 'cui_str': 'Disturbance of consciousness'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0487019', 'cui_str': 'Interleukin 2 receptor, soluble'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}]",42.0,0.0556524,"Positron emission tomography-computed tomography revealed a high incidence of bone marrow (26/34, 76·5%), spleen (19/34, 55·9%) and adrenal gland (9/34, 26·5%) involvement.","[{'ForeName': 'Kosei', 'Initials': 'K', 'LastName': 'Matsue', 'Affiliation': 'Division of Haematology/Oncology, Department of Internal Medicine, Kameda Medical Centre, Chiba, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Abe', 'Affiliation': 'Division of Haematology/Oncology, Department of Internal Medicine, Kameda Medical Centre, Chiba, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Narita', 'Affiliation': 'Division of Haematology/Oncology, Department of Internal Medicine, Kameda Medical Centre, Chiba, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Kobayashi', 'Affiliation': 'Division of Haematology/Oncology, Department of Internal Medicine, Kameda Medical Centre, Chiba, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Kitadate', 'Affiliation': 'Division of Haematology/Oncology, Department of Internal Medicine, Kameda Medical Centre, Chiba, Japan.'}, {'ForeName': 'Masami', 'Initials': 'M', 'LastName': 'Takeuchi', 'Affiliation': 'Division of Haematology/Oncology, Department of Internal Medicine, Kameda Medical Centre, Chiba, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Miura', 'Affiliation': 'Division of Haematology/Oncology, Department of Internal Medicine, Kameda Medical Centre, Chiba, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Takeuchi', 'Affiliation': 'Division of Pathology, The Cancer Institute, Japanese Foundation for Cancer Research, Tokyo, Japan.'}]",British journal of haematology,['10.1111/bjh.16081']
2372,31491384,Antibiotics-Driven Gut Microbiome Perturbation Alters Immunity to Vaccines in Humans.,"Emerging evidence indicates a central role for the microbiome in immunity. However, causal evidence in humans is sparse. Here, we administered broad-spectrum antibiotics to healthy adults prior and subsequent to seasonal influenza vaccination. Despite a 10,000-fold reduction in gut bacterial load and long-lasting diminution in bacterial diversity, antibody responses were not significantly affected. However, in a second trial of subjects with low pre-existing antibody titers, there was significant impairment in H1N1-specific neutralization and binding IgG1 and IgA responses. In addition, in both studies antibiotics treatment resulted in (1) enhanced inflammatory signatures (including AP-1/NR4A expression), observed previously in the elderly, and increased dendritic cell activation; (2) divergent metabolic trajectories, with a 1,000-fold reduction in serum secondary bile acids, which was highly correlated with AP-1/NR4A signaling and inflammasome activation. Multi-omics integration revealed significant associations between bacterial species and metabolic phenotypes, highlighting a key role for the microbiome in modulating human immunity.",2019,"However, in a second trial of subjects with low pre-existing antibody titers, there was significant impairment in H1N1-specific neutralization and binding IgG1 and IgA responses.","['healthy adults prior and subsequent to seasonal influenza vaccination', 'Humans']",['Antibiotics-Driven Gut Microbiome Perturbation'],"['dendritic cell activation; (2) divergent metabolic trajectories', 'H1N1-specific neutralization and binding IgG1 and IgA responses', 'gut bacterial load and long-lasting diminution in bacterial diversity, antibody responses']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}]","[{'cui': 'C0003315', 'cui_str': 'Immunologic Accessory Cells'}, {'cui': 'C0580264', 'cui_str': 'H1N1'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0020855', 'cui_str': 'Immunoglobulin IgG1'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C2936404', 'cui_str': 'Bacterial Load'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0332511', 'cui_str': 'Decreased size'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}]",2.0,0.024709,"However, in a second trial of subjects with low pre-existing antibody titers, there was significant impairment in H1N1-specific neutralization and binding IgG1 and IgA responses.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hagan', 'Affiliation': 'Institute for Immunity, Transplantation and Infection, School of Medicine, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Cortese', 'Affiliation': 'Institute for Immunity, Transplantation and Infection, School of Medicine, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Rouphael', 'Affiliation': 'Hope Clinic of the Emory Vaccine Center, Decatur, GA 30030, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Boudreau', 'Affiliation': 'Ragon Institute of MGH, MIT and Harvard, Cambridge, MA 02139, USA.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Linde', 'Affiliation': 'Ragon Institute of MGH, MIT and Harvard, Cambridge, MA 02139, USA.'}, {'ForeName': 'Mohan S', 'Initials': 'MS', 'LastName': 'Maddur', 'Affiliation': 'Emory Vaccine Center, Yerkes National Primate Research Center, Atlanta, GA 30329, USA.'}, {'ForeName': 'Jishnu', 'Initials': 'J', 'LastName': 'Das', 'Affiliation': 'Ragon Institute of MGH, MIT and Harvard, Cambridge, MA 02139, USA.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Emory Vaccine Center, Yerkes National Primate Research Center, Atlanta, GA 30329, USA.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Guthmiller', 'Affiliation': 'Department of Medicine, Section of Rheumatology, Knapp Center for Lupus and Immunology, University of Chicago, Chicago, IL 60637, USA.'}, {'ForeName': 'Nai-Ying', 'Initials': 'NY', 'LastName': 'Zheng', 'Affiliation': 'Department of Medicine, Section of Rheumatology, Knapp Center for Lupus and Immunology, University of Chicago, Chicago, IL 60637, USA.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Department of Medicine, Section of Rheumatology, Knapp Center for Lupus and Immunology, University of Chicago, Chicago, IL 60637, USA.'}, {'ForeName': 'Amit A', 'Initials': 'AA', 'LastName': 'Uphadhyay', 'Affiliation': 'Emory Vaccine Center, Yerkes National Primate Research Center, Atlanta, GA 30329, USA.'}, {'ForeName': 'Luiz', 'Initials': 'L', 'LastName': 'Gardinassi', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, GA 30303, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Petitdemange', 'Affiliation': 'Emory Vaccine Center, Yerkes National Primate Research Center, Atlanta, GA 30329, USA.'}, {'ForeName': 'Michele Paine', 'Initials': 'MP', 'LastName': 'McCullough', 'Affiliation': 'Hope Clinic of the Emory Vaccine Center, Decatur, GA 30030, USA.'}, {'ForeName': 'Sara Jo', 'Initials': 'SJ', 'LastName': 'Johnson', 'Affiliation': 'Hope Clinic of the Emory Vaccine Center, Decatur, GA 30030, USA.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Gill', 'Affiliation': 'Emory Vaccine Center, Yerkes National Primate Research Center, Atlanta, GA 30329, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Cervasi', 'Affiliation': 'Emory Vaccine Center, Yerkes National Primate Research Center, Atlanta, GA 30329, USA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': 'Center for Inflammation, Immunity, and Infection, Institute for Biomedical Sciences, Georgia State University, Atlanta, GA 30303, USA.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Bretin', 'Affiliation': 'Center for Inflammation, Immunity, and Infection, Institute for Biomedical Sciences, Georgia State University, Atlanta, GA 30303, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Hahn', 'Affiliation': 'Division of Viral Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Gewirtz', 'Affiliation': 'Center for Inflammation, Immunity, and Infection, Institute for Biomedical Sciences, Georgia State University, Atlanta, GA 30303, USA.'}, {'ForeName': 'Steve E', 'Initials': 'SE', 'LastName': 'Bosinger', 'Affiliation': 'Emory Vaccine Center, Yerkes National Primate Research Center, Atlanta, GA 30329, USA.'}, {'ForeName': 'Patrick C', 'Initials': 'PC', 'LastName': 'Wilson', 'Affiliation': 'Department of Medicine, Section of Rheumatology, Knapp Center for Lupus and Immunology, University of Chicago, Chicago, IL 60637, USA.'}, {'ForeName': 'Shuzhao', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, GA 30303, USA.'}, {'ForeName': 'Galit', 'Initials': 'G', 'LastName': 'Alter', 'Affiliation': 'Ragon Institute of MGH, MIT and Harvard, Cambridge, MA 02139, USA.'}, {'ForeName': 'Surender', 'Initials': 'S', 'LastName': 'Khurana', 'Affiliation': 'Division of Viral Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Golding', 'Affiliation': 'Division of Viral Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA.'}, {'ForeName': 'Bali', 'Initials': 'B', 'LastName': 'Pulendran', 'Affiliation': 'Institute for Immunity, Transplantation and Infection, School of Medicine, Stanford University, Stanford, CA 94305, USA; Department of Pathology, Stanford University School of Medicine, Stanford University, Stanford, CA 94305, USA; Department of Microbiology & Immunology, Stanford University School of Medicine, Stanford University, Stanford, CA 94305, USA. Electronic address: bpulend@stanford.edu.'}]",Cell,['10.1016/j.cell.2019.08.010']
2373,31511385,A Replication-Defective Human Cytomegalovirus Vaccine Elicits Humoral Immune Responses Analogous to Those with Natural Infection.,"Human cytomegalovirus (HCMV) can cause congenital infections, which are a leading cause of childhood disabilities. Since the rate of maternal-fetal transmission is much lower in naturally infected (HCMV-seropositive) women, we hypothesize that a vaccine candidate capable of eliciting immune responses analogous to those of HCMV-seropositive subjects may confer protection against congenital HCMV. We have previously described a replication-defective virus vaccine based on strain AD169 (D. Wang, D. C. Freed, X. He, F. Li, et al., Sci Transl Med 8:362ra145, 2016, https://doi.org/10.1126/scitranslmed.aaf9387). The vaccine, named V160, has been shown to be safe and immunogenic in HCMV-seronegative human subjects, eliciting both humoral and cellular immune responses (S. P. Adler, S. E. Starr, S. A. Plotkin, S. H. Hempfling, et al., J Infect Dis 220:411-419, 2019, https://doi.org/10.1093/infdis/171.1.26). Here, we further showed that sera from V160-immunized HCMV-seronegative subjects have attributes similar in quality to those from seropositive subjects, including high-avidity antibodies to viral antigens, coverage against a panel of genetically distinct clinical isolates, and protection against viral infection in diverse types of human cells in culture. More importantly, vaccination appeared efficient in priming the human immune system, inducing memory B cells in six V160 recipients at frequencies comparable to those of three HCMV-seropositive subjects. Our results demonstrate the ability of V160 to induce robust and durable humoral memory responses to HCMV, justifying further clinical evaluation of the vaccine against congenital HCMV. IMPORTANCE   In utero  HCMV infection can lead to miscarriage or childhood disabilities, and an effective vaccine is urgently needed. Since children born to women who are seropositive prior to pregnancy are less likely to be affected by congenital HCMV infection, it has been hypothesized that a vaccine capable of inducing an immune response resembling the responses in HCMV-seropositive women may be effective. We previously described a replication-defective virus vaccine that has been demonstrated safe and immunogenic in HCMV-seronegative subjects. Here, we conducted additional analyses to show that the vaccine can induce antibodies with functional attributes similar to those from HCMV-seropositive subjects. Importantly, vaccination can induce long-lived memory B cells at frequencies comparable to those seen in HCMV-seropositive subjects. We conclude that this vaccine is a promising candidate that warrants further clinical evaluation for prevention of congenital HCMV.",2019,"The vaccine, named V160, has been shown to be safe and immunogenic in HCMV-seronegative human subjects, eliciting both humoral and cellular immune responses (S. P. Adler, S. E. Starr, S. A. Plotkin, S. H. Hempfling, et al., J Infect Dis 220:411-419, 2019, https://doi.org/10.1093/infdis/171.1.26).","['HCMV-seronegative subjects', 'HCMV-seronegative human subjects']","['Sci Transl Med', 'vaccine']",['memory B cells'],"[{'cui': 'C0205725', 'cui_str': 'Human Herpesvirus 5 species'}, {'cui': 'C0521144', 'cui_str': 'Seronegative'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}]",,0.0304912,"The vaccine, named V160, has been shown to be safe and immunogenic in HCMV-seronegative human subjects, eliciting both humoral and cellular immune responses (S. P. Adler, S. E. Starr, S. A. Plotkin, S. H. Hempfling, et al., J Infect Dis 220:411-419, 2019, https://doi.org/10.1093/infdis/171.1.26).","[{'ForeName': 'Yaping', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Freed', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Leike', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Texas Therapeutics Institute, Brown Foundation Institute of Molecular Medicine, The University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Aimin', 'Initials': 'A', 'LastName': 'Tang', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Fengsheng', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Murray', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Stuart P', 'Initials': 'SP', 'LastName': 'Adler', 'Affiliation': 'CMV Foundation, Richmond, Virginia, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'McVoy', 'Affiliation': 'Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Rupp', 'Affiliation': 'The University of Texas Medical Branch, Galveston, Texas, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Barrett', 'Affiliation': 'The University of Texas Medical Branch, Galveston, Texas, USA.'}, {'ForeName': 'Xiaohua', 'Initials': 'X', 'LastName': 'Ye', 'Affiliation': 'Texas Therapeutics Institute, Brown Foundation Institute of Molecular Medicine, The University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Ningyan', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Texas Therapeutics Institute, Brown Foundation Institute of Molecular Medicine, The University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Beck', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Culp', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Rituparna', 'Initials': 'R', 'LastName': 'Das', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Kalpit', 'Initials': 'K', 'LastName': 'Vora', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Rutgers New Jersey Medical School, Newark, New Jersey, USA.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA dai_wang@merck.com Tong-Ming.Fu@uth.tmc.edu.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Espeseth', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'An', 'Affiliation': 'Texas Therapeutics Institute, Brown Foundation Institute of Molecular Medicine, The University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Luwy', 'Initials': 'L', 'LastName': 'Musey', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Tong-Ming', 'Initials': 'TM', 'LastName': 'Fu', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA dai_wang@merck.com Tong-Ming.Fu@uth.tmc.edu.'}]",Journal of virology,['10.1128/JVI.00747-19']
2374,31567306,"Effect of Inhalation Aromatherapy on Pain, Anxiety, Comfort, and Cortisol Levels During Trigger Point Injection.","The objective of this study was to examine the effects of inhaler aromatherapy on the level of pain, comfort, anxiety, and cortisol during trigger point injection in individuals with myofascial pain syndrome. Lavender oil inhalation was found to reduce pain and anxiety during trigger point injection and to improve patient comfort, but it did not affect the saliva cortisol level.",2020,"Lavender oil inhalation was found to reduce pain and anxiety during trigger point injection and to improve patient comfort, but it did not affect the saliva cortisol level.",['individuals with myofascial pain syndrome'],"['inhaler aromatherapy', 'Inhalation Aromatherapy', 'Lavender oil inhalation']","['saliva cortisol level', 'Pain, Anxiety, Comfort, and Cortisol Levels', 'level of pain, comfort, anxiety, and cortisol', 'patient comfort', 'pain and anxiety']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C0064694', 'cui_str': 'lavender oil'}]","[{'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}]",,0.0228124,"Lavender oil inhalation was found to reduce pain and anxiety during trigger point injection and to improve patient comfort, but it did not affect the saliva cortisol level.","[{'ForeName': 'Kadriye Sayin', 'Initials': 'KS', 'LastName': 'Kasar', 'Affiliation': 'Internal Medicine Nursing, Department of Nursing, Faculty of Health Sciences, Aksaray University, Aksaray, Turkey (Dr Sayin Kasar); and Internal Medical Nursing, Faculty of Nursing (Drs Yildirim and Senuzun Aykar), Department of Algology, Faculty of Medicine (Dr Uyar), and Department of Medical Biochemistry, Faculty of Medicine (Drs Girgin Sagin and Atay), Ege University, Izmir, Turkey.'}, {'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Yildirim', 'Affiliation': ''}, {'ForeName': 'Fisun', 'Initials': 'F', 'LastName': 'Senuzun Aykar', 'Affiliation': ''}, {'ForeName': 'Meltem', 'Initials': 'M', 'LastName': 'Uyar', 'Affiliation': ''}, {'ForeName': 'Ferhan Girgin', 'Initials': 'FG', 'LastName': 'Sagin', 'Affiliation': ''}, {'ForeName': 'Sevcan', 'Initials': 'S', 'LastName': 'Atay', 'Affiliation': ''}]",Holistic nursing practice,['10.1097/HNP.0000000000000350']
2375,31622131,Incidence of Late Relapses in Patients With HER2-Positive Breast Cancer Receiving Adjuvant Trastuzumab: Combined Analysis of NCCTG N9831 (Alliance) and NRG Oncology/NSABP B-31.,"PURPOSE


Recent trials have shown potential benefit of extended adjuvant endocrine therapy and relatively high risk of recurrence (RoR) after 5 years in hormone receptor-positive (HR+) human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Although risk of late relapse in HR+ HER2- breast cancer is fairly well defined, the risk in HER2-positive (HER2+) breast cancer treated with adjuvant trastuzumab-based chemotherapy remains largely unknown.
METHODS


We included 3,177 patients with HER2+ breast cancer treated with adjuvant chemotherapy alone or with trastuzumab from the North Central Cancer Treatment Group N9831 (ClinicalTrials.gov identifier: NCT00005970) and National Surgical Adjuvant Breast and Bowel Project B-31 (ClinicalTrials.gov identifier: NCT00004067) trials.
RESULTS


Overall, HR+ breast cancer was significantly associated with improved recurrence-free survival (RFS) during the first 5 years (hazard ratio, 0.65; 95% CI, 0.56 to 0.77;  P  < .001). Among patients treated with trastuzumab, cumulative hazard for RFS was lower in patients with HR+ HER2+ breast cancer during the first 5 years (10.96%  v  17.48%; hazard ratio, 0.60; 95% CI, 0.45 to 0.79;  P  < .001). However, there was no significant difference in RFS based on HR status during years 5 to 10 (hazard ratio, 1.32; 95% CI, 0.93 to 1.88;  P  = .12). A comparable degree of trastuzumab benefit was observed in HR+ and HR- breast cancers (  P  for interaction = .87). Furthermore, we observed low RoR in years 5 to 10 among patients with HR+ HER2+ breast cancer: 3.23% in patients without lymph node involvement (N0) and 6.39% in patients with involvement of one to three lymph nodes (N1).
CONCLUSION


The benefit of adjuvant trastuzumab persists for a long time. A distinct pattern of recurrence was observed between HR+ and HR- HER2+ disease but with similar degree of benefit from adjuvant trastuzumab. RoR in years 5 to 10 in HR+ HER2+ breast cancer is low, particularly in patients with N0 or N1 disease.",2019,"Among patients treated with trastuzumab, cumulative hazard for RFS was lower in patients with HR+ HER2+ breast cancer during the first 5 years (10.96%  v  17.48%; hazard ratio, 0.60; 95% CI, 0.45 to 0.79;  P  < .001).","['Patients With HER2-Positive Breast Cancer Receiving', 'patients with N0 or N1 disease', '3,177 patients with HER2+ breast cancer treated with']","['adjuvant trastuzumab', 'adjuvant chemotherapy alone or with trastuzumab from the North Central Cancer Treatment', 'Adjuvant Trastuzumab']","['HR+ and HR- breast cancers', 'cumulative hazard for RFS', 'recurrence-free survival (RFS', 'Incidence of Late Relapses', 'RFS based on HR status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",3177.0,0.040459,"Among patients treated with trastuzumab, cumulative hazard for RFS was lower in patients with HR+ HER2+ breast cancer during the first 5 years (10.96%  v  17.48%; hazard ratio, 0.60; 95% CI, 0.45 to 0.79;  P  < .001).","[{'ForeName': 'Saranya', 'Initials': 'S', 'LastName': 'Chumsri', 'Affiliation': 'Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Serie', 'Affiliation': 'Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Mashadi-Hossein', 'Affiliation': 'NanoString, Seattle, WA.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Colon-Otero', 'Affiliation': 'Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Song', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Pogue-Geile', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Patrick G', 'Initials': 'PG', 'LastName': 'Gavin', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Soonmyung', 'Initials': 'S', 'LastName': 'Paik', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Moreno-Aspitia', 'Affiliation': 'Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'Edith A', 'Initials': 'EA', 'LastName': 'Perez', 'Affiliation': 'Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'E Aubrey', 'Initials': 'EA', 'LastName': 'Thompson', 'Affiliation': 'Mayo Clinic, Jacksonville, FL.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00443']
2376,31725101,Saffron (Crocus sativus L.): A Phytomedicine as Effective as Methylphenidate in Treating ADHD in Children.,,2020,,['Children'],"['Methylphenidate', 'Saffron (Crocus sativus L']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0162753', 'cui_str': 'Saffron Stain'}, {'cui': 'C0946614', 'cui_str': 'Saffron Crocus'}]",[],,0.0270264,,"[{'ForeName': 'Stephanie Maxine', 'Initials': 'SM', 'LastName': 'Ross', 'Affiliation': 'Consultant, Complementary Integrative Therapies.'}]",Holistic nursing practice,['10.1097/HNP.0000000000000365']
2377,31196847,Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.,"Ibrutinib, a first-in-class once-daily oral Bruton tyrosine kinase inhibitor indicated for chronic lymphocytic leukemia (CLL), is continued until progressive disease or unacceptable toxicity. We conducted an integrated safety analysis of single-agent ibrutinib from randomized phase 3 studies PCYC-1112 (RESONATE, n = 195) and PCYC-1115/1116 (RESONATE-2, n = 135), and examined longer-term safety separately in the phase 1b/2 PCYC-1102/1103 study (n = 94, 420 mg/d). In the integrated analysis (ibrutinib treatment up to 43 months), the most common adverse events (AEs) were primarily grade 1/2; diarrhea (n = 173, 52% any-grade; n = 15, 5% grade 3) and fatigue (n = 119, 36% any-grade; n = 10, 3% grade 3). The most common grade 3/4 AEs were neutropenia (n = 60, 18%) and pneumonia (n = 38, 12%). Over time, prevalence of AEs of interest (diarrhea, fatigue, grade ≥3 infection, bleeding, and neutropenia) trended down; prevalence of hypertension increased, but incidence decreased after year 1. AEs led to dose reductions in 42 (13%) patients and permanent discontinuations in 37 (11%); dose modifications due to AEs were most common during year 1 and decreased in frequency thereafter. The most common AEs (preferred term) contributing to discontinuation included pneumonia (n = 4), anemia (n = 3), and atrial fibrillation (n = 3). With long-term follow-up on PCYC-1102/1103 (ibrutinib treatment up to 67 months), grade 3/4 AEs were generally similar to those in the integrated analysis. Overall, AEs were primarily grade 1/2 and manageable during prolonged ibrutinib treatment in patients with CLL. These trials were registered at www.clinicaltrials.gov as #NCT01578707, #NCT01722487, #NCT01724346, #NCT01105247, and #NCT01109069.",2019,"Over time, prevalence of AEs of interest (diarrhea, fatigue, grade ≥3 infection, bleeding, and neutropenia) trended down; prevalence of hypertension increased, but incidence decreased after year 1.","['chronic lymphocytic leukemia (CLL', 'patients with chronic lymphocytic leukemia in 3 pivotal studies']","['PCYC-1115/1116', 'single-agent ibrutinib']","['diarrhea', 'neutropenia', 'fatigue', 'prevalence of AEs of interest (diarrhea, fatigue, grade ≥3 infection, bleeding, and neutropenia) trended down; prevalence of hypertension', 'atrial fibrillation']","[{'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C3501358', 'cui_str': 'Ibrutinib'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0040833', 'cui_str': 'trends'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]",,0.103485,"Over time, prevalence of AEs of interest (diarrhea, fatigue, grade ≥3 infection, bleeding, and neutropenia) trended down; prevalence of hypertension increased, but incidence decreased after year 1.","[{'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Coutre', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Byrd', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, OH.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillmen', 'Affiliation': ""Leeds Cancer Centre, St. James's Institute of Oncology, Leeds, United Kingdom.""}, {'ForeName': 'Jacqueline C', 'Initials': 'JC', 'LastName': 'Barrientos', 'Affiliation': 'Hofstra Northwell School of Medicine, Hempstead, NY.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Barr', 'Affiliation': 'Wilmot Cancer Institute, University of Rochester Cancer Center, Rochester, NY.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Devereux', 'Affiliation': ""King's College Hospital, National Health Service Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Tadeusz', 'Initials': 'T', 'LastName': 'Robak', 'Affiliation': 'Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Kipps', 'Affiliation': 'Moores Cancer Center, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Schuh', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Moreno', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Richard R', 'Initials': 'RR', 'LastName': 'Furman', 'Affiliation': 'Weill Cornell Medical College, New York Presbyterian Hospital, New York, NY.'}, {'ForeName': 'Jan A', 'Initials': 'JA', 'LastName': 'Burger', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': ""O'Dwyer"", 'Affiliation': 'University College Hospital Galway, Galway, Ireland.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Ghia', 'Affiliation': 'Università Vita-Salute San Raffaele and Istituto di Ricovero e Cura a Carattere Scientifico Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Rudolph', 'Initials': 'R', 'LastName': 'Valentino', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA; and.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Chang', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA; and.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Dean', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA; and.'}, {'ForeName': 'Danelle F', 'Initials': 'DF', 'LastName': 'James', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA; and.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': 'Chao Family Comprehensive Cancer Center, University of California Irvine, Irvine, CA.'}]",Blood advances,['10.1182/bloodadvances.2018028761']
2378,32073793,[New test to detect food allergy: the basophil activation test].,"Over recent decades the prevalence of food allergies and the allergy-related costs of care have increased considerably. The double-blind, placebo-controlled food challenge test is the gold standard for diagnosing food allergy. However, this test is not without risk and it is labour-intensive and expensive. In addition, the food challenge test only has limited availability which has led to (long) waiting lists. Therefore, there is a need for a safe, reliable and patient-friendly test to detect food allergy that is also fast and cheap. The basophil activation test is a potentially good alternative, however, it is only available at a few clinics and laboratories in the Netherlands and it can currently only be used for a limited number of allergens - and therefore only in a limited number of patients. National collaboration between laboratories and allergy centres should lead to more knowledge, the consolidation of which will benefit the validation and national implementation of the test.",2019,Over recent decades the prevalence of food allergies and the allergy-related costs of care have increased considerably.,[],['placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0266227,Over recent decades the prevalence of food allergies and the allergy-related costs of care have increased considerably.,"[{'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'van Setten', 'Affiliation': 'Rijnstate, Afd. Kindergeneeskunde, Arnhem.'}, {'ForeName': 'Ad', 'Initials': 'A', 'LastName': 'Jansen', 'Affiliation': 'Allergologie Centrum Arnhem/Velp, Velp.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Brouwer', 'Affiliation': 'Canisius-Wilhelmina Ziekenhuis, afd. Kindergeneeskunde, Nijmegen.'}, {'ForeName': 'Janneke', 'Initials': 'J', 'LastName': 'Ruinemans-Koerts', 'Affiliation': 'Rijnstate, Klinisch Chemisch en Hematologisch Laboratorium, Arnhem.'}]",Nederlands tijdschrift voor geneeskunde,[]
2379,31764454,Central-Positive Complexes: A Novel Characterization of Ictal Markers Induced During Electroconvulsive Therapy.,"OBJECTIVES


Electroencephalography (EEG) allows monitoring of generalized seizures induced during electroconvulsive therapy (ECT). Scalp EEG recordings show different phases of electroencephalographic ictal activity during ECT seizures, documenting a pattern of seizures that may vary within and across individuals. In this case series, we used 64-electrode high-density EEG recording to detect topographic electroencephalographic changes not typically evident with conventional limited montages commonly used during ECT.
METHODS


The EEG recordings were acquired from 5 participants (24 ECT sessions) during index courses for treatment-resistant depression. Using previously proposed staging criteria, the ictal EEG and simultaneously acquired video were interpreted by an expert reviewer blinded to study treatment parameters.
RESULTS


The EEG recordings of all seizures showed generalized, high-amplitude, central-positive complexes (CPCs), which emerged at the beginning of phase III (polyspike and slow wave activity), with median duration of 47 seconds (interquartile range, 77 seconds), ranging from 14 to 203 seconds. Although individuals showed variability in frequency and amplitude of CPCs, CPCs typically evolved from 4.0 to 1.5 Hz in frequency and decreased in amplitude as the seizure progressed. Elaborating on previously described phases of ECT-induced electrographic seizures, we describe variability in morphology at seizure termination. Initiation of CPCs typically corresponded with clonic movements, but often terminated after motor signs ceased.
CONCLUSIONS


Generalized, high-amplitude, CPCs during ECT are a previously uncharacterized ictal waveform during ECT, which may have important scientific and clinical value. These complexes offer a specific marker for correlating clinical outcomes in ECT and greater understanding of generalized tonic-clonic seizures.",2019,"The EEG recordings of all seizures showed generalized, high-amplitude, central-positive complexes (CPCs), which emerged at the beginning of phase III (polyspike and slow wave activity), with median duration of 47 seconds (interquartile range, 77 seconds), ranging from 14 to 203 seconds.",[],"['Electroencephalography (EEG', 'Central-Positive Complexes', 'electroconvulsive therapy (ECT', '64-electrode high-density EEG recording', 'Electroconvulsive Therapy']",[],[],"[{'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0178587', 'cui_str': 'Density'}]",[],,0.0591112,"The EEG recordings of all seizures showed generalized, high-amplitude, central-positive complexes (CPCs), which emerged at the beginning of phase III (polyspike and slow wave activity), with median duration of 47 seconds (interquartile range, 77 seconds), ranging from 14 to 203 seconds.","[{'ForeName': 'R Edward', 'Initials': 'RE', 'LastName': 'Hogan', 'Affiliation': 'From the Department of Neurology, Washington University in St. Louis, St. Louis, MO.'}, {'ForeName': 'Emma R', 'Initials': 'ER', 'LastName': 'Trammel', 'Affiliation': 'Neuroscience Graduate Program, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Nuri B', 'Initials': 'NB', 'LastName': 'Farber', 'Affiliation': 'Departments of Psychiatry.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Avidan', 'Affiliation': 'Anesthesiology, Washington University in St. Louis, St. Louis, MO.'}, {'ForeName': 'Ben Julian A', 'Initials': 'BJA', 'LastName': 'Palanca', 'Affiliation': 'Anesthesiology, Washington University in St. Louis, St. Louis, MO.'}]",The journal of ECT,['10.1097/YCT.0000000000000597']
2380,29766403,Teacher Involvement Prevents Increases in Children's Depressive Symptoms: Bidirectional Associations in Elementary School.,"There is accumulating evidence that social relationships can buffer the development of depression in childhood and adolescence. However, few studies have focused on teacher-child relationships in the elementary school years. In addition, research that has examined bidirectional relations between teacher involvement and depressive symptoms is virtually absent in this age period. The participants in this study were 570 children and 30 teachers from 15 elementary schools. Data on children's depressive symptoms (peer- and teacher-reports) and teacher involvement (teacher-reports) were collected in the fall and spring of Grade 2 and Grade 3 (four waves). As expected, negative cross-time effects of teacher involvement on depressive symptoms were found within grade 2 and 3. In addition, a negative cross-time effect of depressive symptoms on teacher involvement was found in grade 3 only. The results thus indicate the protective role of teacher involvement in the development of depressive symptoms but also suggest that teachers may become less involved over time when they perceive a child as more depressed.",2019,"As expected, negative cross-time effects of teacher involvement on depressive symptoms were found within grade 2 and 3.",['570 children and 30 teachers from 15 elementary schools'],[],['depressive symptoms'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0036375', 'cui_str': 'School'}]",[],"[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",570.0,0.0302445,"As expected, negative cross-time effects of teacher involvement on depressive symptoms were found within grade 2 and 3.","[{'ForeName': 'Jantine L', 'Initials': 'JL', 'LastName': 'Spilt', 'Affiliation': 'Faculty of Psychology and Educational Sciences, KU Leuven - University of Leuven, Tiensestraat 102 - bus 3717, 3000, Leuven, Belgium. Jantine.spilt@kuleuven.be.'}, {'ForeName': 'Geertje', 'Initials': 'G', 'LastName': 'Leflot', 'Affiliation': 'Applied Psychology, University College Thomas More Antwerpen, Antwerpen, Belgium.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Colpin', 'Affiliation': 'Faculty of Psychology and Educational Sciences, KU Leuven - University of Leuven, Tiensestraat 102 - bus 3717, 3000, Leuven, Belgium.'}]",Journal of abnormal child psychology,['10.1007/s10802-018-0441-7']
2381,32539729,"Newborn Behavioral Observation, maternal stress, depressive symptoms and the mother-infant relationship: results from the Northern Babies Longitudinal Study (NorBaby).","BACKGROUND


Families can experience the postpartum period as overwhelming and many report a special need for support. The Newborn Behavioral Observation (NBO) aims to promote a positive parent-infant relationship by sensitising parents to the infant's signals. This article evaluates the NBO as a universal preventive intervention within the regular well-baby clinic service on measures of maternal depressive symptoms, parental stress, the mother-infant relationship and satisfaction/benefit of the postpartum follow-up.
METHODS


This investigation is part of a larger longitudinal study comprising 220 women and 130 of their partners recruited between 2015 and 2017. The study had a non-randomised cluster-controlled design with 6 measurement points. This article is based on a sample of 196 women using data from T1 (gestational weeks 13-39), T4 (5-15 weeks postpartum) and T5 (3-9 months postpartum). Participants were allocated to a group receiving the NBO (n = 82) and a care as usual comparison group (n = 114). We measured maternal depressive symptoms and parental stress using the Edinburgh Postnatal Depression Scale (EPDS) and the Parenting Stress Index (PSI). The mother-infant relationship was assessed with the Parental Reflective Functioning Questionnaire (PRFQ), the Maternal Postnatal Attachment Scale (MPAS) and the Maternal Confidence Questionnaire (MCQ). Participants also answered questions about satisfaction/benefit of the postpartum follow-up.
RESULTS


A Mann-Whitney U test indicated that participants in the NBO-group learned significantly more than the comparison group from the follow-up about the baby's signals in relation to sleep/sleep patterns, social interaction and crying/fuzziness. Multivariate analyses of covariance (MANCOVA) and repeated measures ANCOVA found no significant differences between the groups for the mother-infant relationship domain and few differences in depressive symptoms and parental stress. The repeated measures ANCOVA found that participants in the NBO-group scored slightly higher on parental stress, although the difference was small.
CONCLUSIONS


The results indicate that the NBO-group learned more than the comparison group about reading their child's signals in important everyday situations. However, the benefits of the NBO were limited for depressive symptoms, parental stress and self-reported mother-infant relationship. The study sample was generally well-functioning, and the results indicate that the benefits of the NBO may be limited within a well-functioning sample.
TRIAL REGISTRATION


ClinicalTrials, NCT02538497, Registered 2 September 2015.",2020,"A Mann-Whitney U test indicated that participants in the NBO-group learned significantly more than the comparison group from the follow-up about the baby's signals in relation to sleep/sleep patterns, social interaction and crying/fuzziness.","['196 women using data from T1 (gestational weeks 13-39), T4 (5-15\u2009weeks postpartum) and T5 (3-9\u2009months postpartum', '220 women and 130 of their partners recruited between 2015 and 2017']",['NBO'],"['parental stress', 'Newborn Behavioral Observation, maternal stress, depressive symptoms', 'maternal depressive symptoms and parental stress using the Edinburgh Postnatal Depression Scale (EPDS) and the Parenting Stress Index (PSI', 'Parental Reflective Functioning Questionnaire (PRFQ), the Maternal Postnatal Attachment Scale (MPAS) and the Maternal Confidence Questionnaire (MCQ', 'Newborn Behavioral Observation (NBO', 'depressive symptoms and parental stress']","[{'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0558039', 'cui_str': 'Observation of behavior'}]","[{'cui': 'C1999012', 'cui_str': 'Parental role conflict'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0558039', 'cui_str': 'Observation of behavior'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",220.0,0.0440688,"A Mann-Whitney U test indicated that participants in the NBO-group learned significantly more than the comparison group from the follow-up about the baby's signals in relation to sleep/sleep patterns, social interaction and crying/fuzziness.","[{'ForeName': 'Ragnhild Sørensen', 'Initials': 'RS', 'LastName': 'Høifødt', 'Affiliation': 'Department of Psychology, Faculty of Health Sciences, UiT The Arctic University of Norway, Tromsø, Norway. ragnhild.s.hoifodt@uit.no.'}, {'ForeName': 'Dag', 'Initials': 'D', 'LastName': 'Nordahl', 'Affiliation': 'Department of Psychology, Faculty of Health Sciences, UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Inger Pauline', 'Initials': 'IP', 'LastName': 'Landsem', 'Affiliation': 'Division of Child and Adolescent Health, University Hospital of Northern Norway, Tromsø, Norway.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Csifcsák', 'Affiliation': 'Department of Psychology, Faculty of Health Sciences, UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Bohne', 'Affiliation': 'Department of Psychology, Faculty of Health Sciences, UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Gerit', 'Initials': 'G', 'LastName': 'Pfuhl', 'Affiliation': 'Department of Psychology, Faculty of Health Sciences, UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Kamilla', 'Initials': 'K', 'LastName': 'Rognmo', 'Affiliation': 'Department of Psychology, Faculty of Health Sciences, UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Hanne C', 'Initials': 'HC', 'LastName': 'Braarud', 'Affiliation': 'Department of Social Science, Faculty of Health and Social Science, Western Norway University of Applied Sciences, Bergen, Norway.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Goksøyr', 'Affiliation': 'Department of Social Science, Faculty of Health and Social Science, Western Norway University of Applied Sciences, Bergen, Norway.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Moe', 'Affiliation': 'Department of Psychology, Faculty of Social Sciences, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Slinning', 'Affiliation': 'Regional Centre for Child and Adolescent Mental Health East and South, Oslo, Norway.'}, {'ForeName': 'Catharina Elisabeth Arfwedson', 'Initials': 'CEA', 'LastName': 'Wang', 'Affiliation': 'Department of Psychology, Faculty of Health Sciences, UiT The Arctic University of Norway, Tromsø, Norway.'}]",BMC psychiatry,['10.1186/s12888-020-02669-y']
2382,32539740,"Efficacy of ""Family Connections"", a program for relatives of people with borderline personality disorder, in the Spanish population: study protocol for a randomized controlled trial.","BACKGROUND


Patients with borderline personality disorder (BPD) experience significant affect regulation difficulties that cause serious consequences in their work, emotional, and social environments. This dysfunctional pattern also produces great suffering and a heavy burden on their relatives. Fortunately, some studies show that treatment of relatives of people with BPD begins to be important in the patients' recovery and in improving family dynamics. One of the treatments that has obtained the most empirical support is Family connections (FC). This 12-session program is an adaptation of different Dialectical Behavior Therapy strategies. To test the efficacy of FC, five uncontrolled clinical trials were conducted, with pre-post treatment and follow-up assessments. The results of these studies and subsequent replications showed an improvement in family attitudes and caregiver burnout. Our research team adapted FC for delivery in the Spanish population. We intend to test the efficacy of this program versus a treatment as usual condition. Moreover, we aim to test the efficacy of this program and study its effectiveness (in terms of participants' acceptance). This paper presents the study protocol.
METHODS


The study is a randomized controlled trial. The participants will be recruited in a Personality Disorders Unit and randomly assigned to one of two treatment conditions: Family Connections group (FC) or Treatment As Usual (TAU). Primary outcome measures will be the BAS and FAD-GFS. Secondary outcomes will include DASS-21, FES, GS, and QLI. Participants' treatment acceptance and degree of satisfaction will also be measured. Participants will be assessed at pre-, post-treatment, and 6-month follow-up. Intention to treat and per protocol analyses will be performed.
DISCUSSION


This is the first study on FC for relatives of people with borderline personality disorder (BPD) compared to an active condition (TAU), and this is the first time relatives' and patients' data will be analyzed. In addition, it is the first study to test the efficacy of the program in Spain. This intervention could contribute to improving the efficiency and effectiveness of current treatment programs for relatives of people with BPD, help to decrease burden, and improve the family connection.
TRIAL REGISTRATION


ClinicalTrials.gov ID: NCT04160871. Registered November 15th 2019.",2020,"This intervention could contribute to improving the efficiency and effectiveness of current treatment programs for relatives of people with BPD, help to decrease burden, and improve the family connection.
","['relatives of people with borderline personality disorder (BPD', 'Patients with borderline personality disorder (BPD', 'relatives of people with BPD', 'relatives of people with borderline personality disorder']","['Family Connections', 'Family Connections group (FC) or Treatment As Usual (TAU']","['efficiency and effectiveness', 'BAS and FAD-GFS', 'family attitudes and caregiver burnout', 'DASS-21, FES, GS, and QLI']","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0015540', 'cui_str': 'Flavin-Adenine Dinucleotide'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C4704714', 'cui_str': 'Caregiver Burnout'}, {'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}, {'cui': 'C0525959', 'cui_str': '16-fluoroestradiol, (16alpha, 17beta)-isomer, (18F)-labeled'}]",,0.0896351,"This intervention could contribute to improving the efficiency and effectiveness of current treatment programs for relatives of people with BPD, help to decrease burden, and improve the family connection.
","[{'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Fernández-Felipe', 'Affiliation': 'Universitat Jaume I, Castellón, Spain. fernandi@uji.es.'}, {'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Guillén', 'Affiliation': 'Universidad de Valencia, Valencia, Spain.'}, {'ForeName': 'Helio', 'Initials': 'H', 'LastName': 'Marco', 'Affiliation': 'Universidad de Valencia, Valencia, Spain.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Díaz-García', 'Affiliation': 'Universitat Jaume I, Castellón, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Botella', 'Affiliation': 'Universitat Jaume I, Castellón, Spain.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Jorquera', 'Affiliation': 'ITA-PREVI (Personality Disorders Centre), Castellón, Valencia and Alicante, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Baños', 'Affiliation': 'Universidad de Valencia, Valencia, Spain.'}, {'ForeName': 'Azucena', 'Initials': 'A', 'LastName': 'García-Palacios', 'Affiliation': 'Universitat Jaume I, Castellón, Spain.'}]",BMC psychiatry,['10.1186/s12888-020-02708-8']
2383,32539752,Open fenestration discectomy versus microscopic fenestration discectomy for lumbar disc herniation: a randomized controlled trial.,"BACKGROUND


Fenestration discectomy, for symptomatic lumbar disc herniation, is the most common surgical procedure in spine surgery. It can be done by open or microscopic procedures. This study compared the results of fenestration microdiscectomy with open fenestration discectomy in the treatment of symptomatic lumbar disc herniation as a relation to the functional outcome, leg pain, back pain, hospital stay, returns to daily activity, cost, recurrence, reoperation and type of surgery for recurrent disc herniation.
METHODS


60 patients age (29 - 50 years), with L4-L5 disc herniation, are divided randomly into group A- 30 patients underwent an open fenestration discectomy- and group B- 30 patients underwent fenestration microdiscectomy. All patients are assessed at 1 week, 3 months, 6 months, 12 months after surgery for Oswestry disability index and Visual analogue scale for back pain and leg pain and followed up for 4 years.
RESULTS


In both groups, all patients have minimal disability by Oswestry Disability Index after surgery. There were significant differences between means of post-operative Visual Analogue Scale for back pain between these two groups after 1 week (3.7 in group A versus 2.2 in group B) (t = 13.28, P = < 0.001*) and after 3 months (1.73 in group A versus 0.43 in group B) (t = 10.54, P = < 0.001*). There were no significant differences between two groups regarding post-operative VAS for leg pain, recurrence (5 patients in group A versus 4 patients in group B) and reoperation rate (2 patients in each group). There were significant differences between means of length of hospital stay (2.10 in group A versus 1.06 in group B) (P < 0.001), time of returning to daily activities (7.33 in group A versus 4.03 in group B) (P < 0.001) and cost of surgery (1996.66 in group A versus 3003.3 in group B) (P < 0.001).
CONCLUSION


Use of microscope in fenestration discectomy for treatment of symptomatic lumbar disc herniation can achieve the same goals of open fenestration regarding nerve root decompression and relief of leg pain with advantage of less back pain, less hospital staying and early return to daily activities with disadvantage of more cost with the use of microscope. With 4 years follow up, there was no significant deference in rate of recurrence and reoperation with the use of microscope but we found that type of surgery for recurrent cases may be less invasive if microscope was used in primary surgery.
TRIAL REGISTRATION


NCT, NCT04112485. Registered 30 September 2019 - Retrospectively registered, https://clinicaltrials.gov/NCT04112485.",2020,"There were significant differences between means of post-operative Visual Analogue Scale for back pain between these two groups after 1 week (3.7 in group A versus 2.2 in group B) (t = 13.28, P = < 0.001*) and after 3 months (1.73 in group A versus 0.43 in group B) (t = 10.54, P = < 0.001*).","['Registered 30 September 2019 - Retrospectively registered, https://clinicaltrials.gov/NCT04112485', '60 patients age (29 - 50\u2009years), with L4-L5 disc herniation', '30 patients underwent', 'lumbar disc herniation', '30 patients underwent an']","['open fenestration discectomy- and group B', 'fenestration microdiscectomy', 'fenestration microdiscectomy with open fenestration discectomy', 'Open fenestration discectomy versus microscopic fenestration discectomy', 'A']","['time of returning to daily activities', 'rate of recurrence and reoperation', 'reoperation rate', 'leg pain, recurrence', 'length of hospital stay', 'minimal disability by Oswestry Disability Index', 'means of post-operative Visual Analogue Scale for back pain', 'functional outcome, leg pain, back pain, hospital stay, returns to daily activity, cost, recurrence, reoperation and type of surgery for recurrent disc herniation', 'cost of surgery', 'Oswestry disability index and Visual analogue scale for back pain and leg pain']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0015825', 'cui_str': 'Inner ear fenestration'}, {'cui': 'C0206078', 'cui_str': 'Discectomy of spine'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0457629', 'cui_str': 'Lumbar microdiscectomy'}, {'cui': 'C0205288', 'cui_str': 'Microscopic'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",60.0,0.0615753,"There were significant differences between means of post-operative Visual Analogue Scale for back pain between these two groups after 1 week (3.7 in group A versus 2.2 in group B) (t = 13.28, P = < 0.001*) and after 3 months (1.73 in group A versus 0.43 in group B) (t = 10.54, P = < 0.001*).","[{'ForeName': 'Sherwan A', 'Initials': 'SA', 'LastName': 'Hamawandi', 'Affiliation': 'Department of Orthopaedics, College of Medicine, Hawler Medical University, Erbil, Iraq. sherwan.hamawandi@hmu.edu.krd.'}, {'ForeName': 'Injam Ibrahim', 'Initials': 'II', 'LastName': 'Sulaiman', 'Affiliation': 'Department of Neurosurgery, College of Medicine, Hawler Medical University, Erbil, Iraq.'}, {'ForeName': 'Ameer Kadhim', 'Initials': 'AK', 'LastName': 'Al-Humairi', 'Affiliation': 'Dept. of Community Medicine, College of Medicine, University of Babylon, Hilla, Iraq.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03396-x']
2384,32539753,Comparable endocrine and neuromuscular adaptations to variable vs. constant gravity-dependent resistance training among young women.,"BACKGROUND


Variable resistance has been shown to induce greater total work and muscle activation when compared to constant resistance. However, little is known regarding the effects of chronic exposure to variable resistance training in comparison with constant resistance training. The aim of the present study was therefore to examine the effects of chain-loaded variable and constant gravity-dependent resistance training on resting hormonal and neuromuscular adaptations.
METHODS


Young women were randomly assigned to variable resistance training (VRT; n = 12; age, 23.75 ± 3.64 years; and BMI, 26.80 ± 4.21 kg m -2 ), constant resistance training (CRT; n = 12; age, 23.58 ± 3.84 years; BMI, 25.25 ± 3.84 kg m -2 ), or control (Con; n = 12; age, 23.50 ± 2.93 years; BMI, 27.12 ± 12 kg m -2 ) groups. CRT performed 8-week total-body free-weight training three times per week with moderate-to-high intensity (65-80% 1RM; periodized). VRT was the same as CRT but included variable resistance via chains (15% of total load). Resting serum samples were taken before and after the 8-week intervention for GH, IGF-1, cortisol, myostatin, and follistatin analyses.
RESULTS


Both VRT and CRT groups displayed moderate-to-large significant increases in GH (197.1%; ES = 0.78 vs. 229.9%; ES = 1.55), IGF-1 (82.3%; ES = 1.87 vs. 66%; ES = 1.66), and follistatin (58.8%; ES = 0.80 vs. 49.15%; ES = 0.80) and decreases in cortisol (- 19.9%; ES = - 1.34 vs. - 17.1%; ES = - 1.05) and myostatin (- 26.9%; ES = - 0.78 vs. - 23.2%; ES = - 0.82). Also, VRT and CRT resulted in large significant increases in bench press (30.54%; ES = 1.45 vs. 25.08%; ES = 1.12) and squat (30.63%; ES = 1.28 vs. 24.81%; ES = 1.21) strength, with no differences between groups.
CONCLUSIONS


Implementing chain-loaded VRT into a periodized resistance training program can be an effective alternative to constant loading during free-weight RT among untrained young women.",2020,"Also, VRT and CRT resulted in large significant increases in bench press (30.54%; ES = 1.45 vs. 25.08%; ES = 1.12) and squat (30.63%; ES = 1.28 vs. 24.81%; ES = 1.21) strength, with no differences between groups.
","['Young women', 'young women', 'untrained young women']","['constant gravity-dependent resistance training', 'chain-loaded variable and constant gravity-dependent resistance training', 'constant resistance training', 'VRT and CRT', 'variable resistance training (VRT', 'VRT']","['GH', 'cortisol', 'follistatin', 'IGF-1']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0282189', 'cui_str': 'Gravity'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0060623', 'cui_str': 'Activin-Binding Protein'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}]",,0.0205341,"Also, VRT and CRT resulted in large significant increases in bench press (30.54%; ES = 1.45 vs. 25.08%; ES = 1.12) and squat (30.63%; ES = 1.28 vs. 24.81%; ES = 1.21) strength, with no differences between groups.
","[{'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Arazi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, University of Guilan, 10 th km of Tehran Road- Khalij-e-Fars Highway, Zip Code: 4199843653, Rasht, Iran. hamidarazi@yahoo.com.'}, {'ForeName': 'Lida', 'Initials': 'L', 'LastName': 'Salek', 'Affiliation': 'Department of Physical Education, Bandar-e-Anzali Branch, Islamic Azad University, Bandar-e-Anzali, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Nikfal', 'Affiliation': 'Department of Physical Education, Bandar-e-Anzali Branch, Islamic Azad University, Bandar-e-Anzali, Iran.'}, {'ForeName': 'Mani', 'Initials': 'M', 'LastName': 'Izadi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, University of Guilan, 10 th km of Tehran Road- Khalij-e-Fars Highway, Zip Code: 4199843653, Rasht, Iran.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Tufano', 'Affiliation': 'Faculty of Physical Education and Sport, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Bradley T', 'Initials': 'BT', 'LastName': 'Elliott', 'Affiliation': 'Translational Physiology Research Group, School of Life Sciences, University of Westminster, London, UK.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Brughelli', 'Affiliation': 'Sports Performance Research Institute New Zealand (SPRINZ), AUT Millennium, Auckland University of Technology, Auckland, New Zealand.'}]",Journal of translational medicine,['10.1186/s12967-020-02411-y']
2385,32539786,Prevention of severe infectious complications after colorectal surgery using oral non-absorbable antimicrobial prophylaxis: results of a multicenter randomized placebo-controlled clinical trial.,"BACKGROUND


Surgical site infections (SSIs) are common complications after colorectal surgery. Oral non-absorbable antibiotic prophylaxis (OAP) can be administered preoperatively to reduce the risk of SSIs. Its efficacy without simultaneous mechanical cleaning is unknown.
METHODS


The Precaution trial was a double-blind, placebo-controlled randomized clinical trial conducted in six Dutch hospitals. Adult patients who underwent elective colorectal surgery were randomized to receive either a three-day course of preoperative OAP with tobramycin and colistin or placebo. The primary composite endpoint was the incidence of deep SSI or mortality within 30 days after surgery. Secondary endpoints included both infectious and non-infectious complications at 30 days and six months after surgery.
RESULTS


The study was prematurely ended due to the loss of clinical equipoise. At that time, 39 patients had been randomized to active OAP and 39 to placebo, which reflected 8.1% of the initially pursued sample size. Nine (11.5%) patients developed the primary outcome, of whom four had been randomized to OAP (4/39; 10.3%) and five to placebo (5/39; 12.8%). This corresponds to a risk ratio in the intention-to-treat analysis of 0.80 (95% confidence interval (CI) 0.23-2.78). In the per-protocol analysis, the relative risk was 0.64 (95% CI 0.12-3.46).
CONCLUSIONS


Observational data emerging during the study provided new evidence for the effectiveness of OAP that changed both the clinical and medical ethical landscape for infection prevention in colorectal surgery. We therefore consider it unethical to continue randomizing patients to placebo. We recommend the implementation of OAP in clinical practice and continuing monitoring of infection rates and antibiotic susceptibilities.
TRIAL REGISTRATION


The PreCaution trial is registered in the Netherlands Trial Register under NL5932 (previously: NTR6113) as well as in the EudraCT register under 2015-005736-17.",2020,This corresponds to a risk ratio in the intention-to-treat analysis of 0.80 (95% confidence interval (CI) 0.23-2.78).,"['Adult patients who underwent elective colorectal surgery', 'six Dutch hospitals', '39 patients had been randomized to active OAP and 39 to']","['OAP', 'colorectal surgery using oral non-absorbable antimicrobial prophylaxis', 'preoperative OAP with tobramycin and colistin or placebo', 'Oral non-absorbable antibiotic prophylaxis (OAP', 'placebo']","['infectious and non-infectious complications', 'incidence of deep SSI or mortality', 'relative risk']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C1527415', 'cui_str': 'Oral route'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0040341', 'cui_str': 'Tobramycin'}, {'cui': 'C0009316', 'cui_str': 'Colistin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}]",,0.768962,This corresponds to a risk ratio in the intention-to-treat analysis of 0.80 (95% confidence interval (CI) 0.23-2.78).,"[{'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Mulder', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Kluytmans-van den Bergh', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Vlaminckx', 'Affiliation': 'Department of Medical Microbiology, St. Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Roos', 'Affiliation': 'Department of Surgery, Reinier de Graaf Gasthuis, Delft, The Netherlands.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'de Smet', 'Affiliation': 'Department of Intensive Care Medicine, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'de Vos Tot Nederveen Cappel', 'Affiliation': 'Department of Surgery, Admiraal de Ruyter Hospital, Goes, The Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Verheijen', 'Affiliation': 'Department of Surgery, Meander Medical Center, Amersfoort, The Netherlands.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Brandt', 'Affiliation': 'Department of Surgery, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Smits', 'Affiliation': 'Department of Surgery, St. Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'van der Vorm', 'Affiliation': 'Department of Medical Microbiology, Reinier de Graaf Gasthuis, Delft, The Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Bathoorn', 'Affiliation': 'Department of Medical Microbiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Boudewijn', 'Initials': 'B', 'LastName': 'van Etten', 'Affiliation': 'Department of Surgery, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Jacobien', 'Initials': 'J', 'LastName': 'Veenemans', 'Affiliation': 'Department of Medical Microbiology, Admiraal de Ruyter Hospital, Goes, the Netherlands.'}, {'ForeName': 'Annemarie', 'Initials': 'A', 'LastName': 'Weersink', 'Affiliation': 'Department of Medical Microbiology, Meander Medical Center, Amersfoort, The Netherlands.'}, {'ForeName': 'Margreet', 'Initials': 'M', 'LastName': 'Vos', 'Affiliation': 'Department of Microbiology and Infectious Diseases, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': ""van 't Veer"", 'Affiliation': 'Department of Clinical Pharmacy, Amphia Hospital, Breda, The Netherlands.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Nikolakopoulos', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Bonten', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Kluytmans', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands. jankluytmans@gmail.com.'}]",Antimicrobial resistance and infection control,['10.1186/s13756-020-00745-2']
2386,32539787,Impact of a group-based intervention program on physical activity and health-related outcomes in worksite settings.,"BACKGROUND


The benefits of physical activity (PA) have been well documented, and the worksite is a promising setting for PA promotion. The aims of this study were as follows: 1. To evaluate the effect of a group-based worksite intervention on PA and health-related outcomes by using pedometers. 2. To examine the associations between the change in vigorous physical activity (VPA)/moderate physical activity (MPA)/walking and health related outcomes.
METHODS


A total of 398 participants (221 in the intervention group (IG) and 177 in the control group (CG)) from 17 worksites were recruited for a prospective self-controlled trial of a worksite physical activity intervention program in China. In the IG, a pedometer was utilized to self-monitor the PA, together with group competition, goal setting, and other incentives. No intervention was applied to the CG. Physical activity, sedentary behavior, and health-related outcomes were measured at baseline and immediately after the 100-day period intervention.
RESULTS


A total of 262 participants completed the program (68.3% adherence). Adherence in the intervention group was 67.9% (n = 150/221). Improvements between baseline and follow-up among intervention participants were observed in the following parameters: VPA (+ 109.7 METs/week; p < 0.05), walking (+ 209.2 METs/week; p < 0.01), systolic blood pressure (SBP; - 2.1 mmHg; p < 0.01), waist circumference (WC; - 2.3 cm; p < 0.01), body fat percentage (BF); - 1.0%; p < 0.01), and body mass index (BMI; - 0.5 kg/m 2 ; p < 0.01). VPA was related to changes in body fat percentage (p < 0.05) and body mass index (p < 0.05).
CONCLUSION


This integrated group-based intervention program contributed to comprehensive improvement in health-related outcomes. The study was useful for establishing associations between change in VPA/MPA/walking and health-related outcomes in a natural setting. Long-term evaluation is required to examine the potential of such an integrated intervention to promote PA.
REGISTRATION


This study was prospectively registered in the Chinese Clinical Trial Registry.
TRIAL REGISTRATION NUMBER


ChiCTR-1,800,015,529. Date of registration: April 5, 2018.",2020,"VPA was related to changes in body fat percentage (p < 0.05) and body mass index (p < 0.05).
","['398 participants (221 in the intervention group (IG) and 177 in the control group (CG)) from 17 worksites were recruited for a prospective self-controlled trial of a', '262 participants completed the program (68.3% adherence']","['worksite physical activity intervention program in China', 'physical activity (PA', 'group-based worksite intervention', 'group-based intervention program']","['waist circumference', 'body fat percentage', 'body mass index', 'Physical activity, sedentary behavior, and health-related outcomes', 'systolic blood pressure', 'vigorous physical activity (VPA)/moderate physical activity (MPA)/walking and health related outcomes', 'Adherence']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",262.0,0.0293454,"VPA was related to changes in body fat percentage (p < 0.05) and body mass index (p < 0.05).
","[{'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Gu', 'Affiliation': 'School of Public Health, Key Lab of Public Health Safety of the Ministry of Education, Fudan University, 130 Dongan Road, Shanghai, 200032, China.'}, {'ForeName': 'Yejing', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Huangpu District Center for Disease Control and Prevention, Shanghai, 200023, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Division of Chronic Non-communicable Disease and Injury, Shanghai Municipal Center for Disease Control and Prevention, 1380 West Zhongshan Road, Shanghai, 200336, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Huangpu District Center for Disease Control and Prevention, Shanghai, 200023, China.'}, {'ForeName': 'Jiying', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Division of Chronic Non-communicable Disease and Injury, Shanghai Municipal Center for Disease Control and Prevention, 1380 West Zhongshan Road, Shanghai, 200336, China.'}, {'ForeName': 'Yingnan', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'School of Public Health, Key Lab of Public Health Safety of the Ministry of Education, Fudan University, 130 Dongan Road, Shanghai, 200032, China. jyn@fudan.edu.cn.'}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Cheng', 'Affiliation': 'Division of Chronic Non-communicable Disease and Injury, Shanghai Municipal Center for Disease Control and Prevention, 1380 West Zhongshan Road, Shanghai, 200336, China. chengminna@scdc.sh.cn.'}]",BMC public health,['10.1186/s12889-020-09036-2']
2387,32539794,Genetic risk prediction of the plasma triglyceride response to independent supplementations with eicosapentaenoic and docosahexaenoic acids: the ComparED Study.,"BACKGROUND


We previously built a genetic risk score (GRS) highly predictive of the plasma triglyceride (TG) response to an omega-3 fatty acid (n-3 FA) supplementation from marine sources. The objective of the present study was to test the potential of this GRS to predict the plasma TG responsiveness to supplementation with either eicosapentaenoic (EPA) or docosahexaenoic (DHA) acids in the Comparing EPA to DHA (ComparED) Study.
METHODS


The ComparED Study is a double-blind, controlled, crossover trial, with participants randomized to three supplemented phases of 10 weeks each: (1) 2.7 g/day of DHA, (2) 2.7 g/day of EPA, and (3) 3 g/day of corn oil (control), separated by 9-week washouts. The 31 SNPs used to build the previous GRS were genotyped in 122 participants of the ComparED Study using TaqMan technology. The GRS for each participant was computed by summing the number of rare alleles. Ordinal and binary logistic models, adjusted for age, sex, and body mass index, were used to calculate the ability of the GRS to predict TG responsiveness.
RESULTS


The GRS predicted TG responsiveness to EPA supplementation (p = 0.006), and a trend was observed for DHA supplementation (p = 0.08). The exclusion of participants with neutral TG responsiveness clarified the association patterns and the predictive capability of the GRS (EPA, p = 0.0003, DHA p = 0.01).
CONCLUSION


Results of the present study suggest that the constructed GRS is a good predictor of the plasma TG response to supplementation with either DHA or EPA.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT01810003. The study protocol was registered on March 4, 2013.",2020,"The GRS predicted TG responsiveness to EPA supplementation (p = 0.006), and a trend was observed for DHA supplementation (p = 0.08).",[],"['corn oil (control', 'omega-3 fatty acid (n-3 FA) supplementation', 'eicosapentaenoic and docosahexaenoic acids', 'eicosapentaenoic (EPA) or docosahexaenoic (DHA) acids']","['plasma triglyceride (TG) response', 'plasma triglyceride response']",[],"[{'cui': 'C0010029', 'cui_str': 'Corn Oil'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}]","[{'cui': 'C0583329', 'cui_str': 'Plasma triglyceride measurement'}]",,0.0857723,"The GRS predicted TG responsiveness to EPA supplementation (p = 0.006), and a trend was observed for DHA supplementation (p = 0.08).","[{'ForeName': 'Bastien', 'Initials': 'B', 'LastName': 'Vallée Marcotte', 'Affiliation': 'Centre Nutrition, Santé et Société-Institut sur la nutrition et les aliments fonctionnels (Institute of Nutrition and Functional Foods (INAF)), Université Laval, 2440 Hochelaga Blvd., Quebec City, Quebec, Canada.'}, {'ForeName': 'Janie', 'Initials': 'J', 'LastName': 'Allaire', 'Affiliation': 'Centre Nutrition, Santé et Société-Institut sur la nutrition et les aliments fonctionnels (Institute of Nutrition and Functional Foods (INAF)), Université Laval, 2440 Hochelaga Blvd., Quebec City, Quebec, Canada.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Guénard', 'Affiliation': 'Centre Nutrition, Santé et Société-Institut sur la nutrition et les aliments fonctionnels (Institute of Nutrition and Functional Foods (INAF)), Université Laval, 2440 Hochelaga Blvd., Quebec City, Quebec, Canada.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'de Toro-Martín', 'Affiliation': 'Centre Nutrition, Santé et Société-Institut sur la nutrition et les aliments fonctionnels (Institute of Nutrition and Functional Foods (INAF)), Université Laval, 2440 Hochelaga Blvd., Quebec City, Quebec, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Couture', 'Affiliation': 'Centre Nutrition, Santé et Société-Institut sur la nutrition et les aliments fonctionnels (Institute of Nutrition and Functional Foods (INAF)), Université Laval, 2440 Hochelaga Blvd., Quebec City, Quebec, Canada.'}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Lamarche', 'Affiliation': 'Centre Nutrition, Santé et Société-Institut sur la nutrition et les aliments fonctionnels (Institute of Nutrition and Functional Foods (INAF)), Université Laval, 2440 Hochelaga Blvd., Quebec City, Quebec, Canada.'}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Vohl', 'Affiliation': 'Centre Nutrition, Santé et Société-Institut sur la nutrition et les aliments fonctionnels (Institute of Nutrition and Functional Foods (INAF)), Université Laval, 2440 Hochelaga Blvd., Quebec City, Quebec, Canada. marie-claude.vohl@fsaa.ulaval.ca.'}]",Genes & nutrition,['10.1186/s12263-020-00669-x']
2388,32539822,Locally implemented prevention programs may reverse weight trajectories in half of children with overweight/obesity amid low child-staff ratios: results from a quasi-experimental study in France.,"BACKGROUND


The aims of the present study were to assess changes in weight status between the first and last year of primary education among children with overweight/obesity in response to locally implemented school-based prevention programs, and to assess the influence of process indicators, expressed as child-staff ratios (CSRs), on these changes.
METHODS


To meet the study objectives, a quasi-experimental design was used. Four municipalities that systematically monitored the weight status of schoolchildren and participated in the ""Vivons en Forme"" program agreed to provide the data available in their school medical service records. The local implementers involved in training sessions were mainly municipal staff in charge of serving midday school meals, which is compulsory in France, and those in charge of designing and facilitating creative, interactive activities at school between and after classes. CSRs were determined by occupation (school catering service/facilitator of extracurricular activities) and training session (healthy eating/physical activity) in each municipality program, and classified as low (1-5 children per adult) or moderate.
RESULTS


During the 4 years of primary education, weight status improved in half of the children with overweight/obesity, and worsened in 6.6% of children with overweight/normal weight. In children who remained overweight, the BMI z-score diminished over time. Estimates of the positive 4-year weight changes were related to low CSRs in locally implemented variations of the program. Estimates increased with age and were significantly higher in low-to-moderate CSR multicomponent interventions than moderate CSR single-component intervention (reference). The moderate CSR multicomponent intervention had a similar effect as the reference. The estimated negative weight change decreased with age.
CONCLUSIONS


Our findings suggest that training ancillary school staff in experiential-focused interventions for healthy eating and physical activity in locally implemented school-based programs contributed positively to reducing childhood obesity during the four years of primary education without interfering with educational activities. The results also provide preliminary evidence that low CSRs could be pivotal for optimal outcomes, especially in deprived areas.",2020,Estimates increased with age and were significantly higher in low-to-moderate CSR multicomponent interventions than moderate CSR single-component intervention (reference).,"['children with overweight/obesity in response to locally implemented school-based prevention programs', 'children with overweight/obesity amid low child-staff ratios']",[],"['weight trajectories', 'childhood obesity', 'BMI z-score', 'negative weight change', 'weight status']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",[],"[{'cui': 'C4704805', 'cui_str': 'Weight Trajectory'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.0118611,Estimates increased with age and were significantly higher in low-to-moderate CSR multicomponent interventions than moderate CSR single-component intervention (reference).,"[{'ForeName': 'Aymery', 'Initials': 'A', 'LastName': 'Constant', 'Affiliation': 'INRAE, INSERM, Univ Rennes, CHU Rennes, Nutrition Metabolisms and Cancer, NuMeCan, Rennes, France. aymery.constant@ehesp.fr.'}, {'ForeName': 'Gaëlle', 'Initials': 'G', 'LastName': 'Boulic', 'Affiliation': 'Vivons en forme Association, 474 Saint-André-Lez-Lille, France.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Lommez', 'Affiliation': 'Vivons en forme Association, 474 Saint-André-Lez-Lille, France.'}, {'ForeName': 'Raphaëlle', 'Initials': 'R', 'LastName': 'Chaillou', 'Affiliation': 'Vivons en forme Association, 474 Saint-André-Lez-Lille, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Guy-Grand', 'Affiliation': 'Paris University Hospital, Paris, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Raffin', 'Affiliation': 'LinkUp company, Levallois, France.'}]",BMC public health,['10.1186/s12889-020-09080-y']
2389,32539832,"Treatment with anagliptin, a DPP-4 inhibitor, decreases FABP4 concentration in patients with type 2 diabetes mellitus at a high risk for cardiovascular disease who are receiving statin therapy.","BACKGROUND


Fatty acid-binding protein 4 (FABP4) acts as a novel adipokine, and elevated FABP4 concentration is associated with obesity, insulin resistance and atherosclerosis. Dipeptidyl peptidase-4 (DPP-4) inhibitors, a class of antidiabetic drugs, have distinct structures among the drugs, possibly leading to a drug class effect and each drug effect. Sitagliptin, a DPP-4 inhibitor, has been reported to decrease FABP4 concentration in drug-naïve and sulfonylurea-treated patients with type 2 diabetes mellitus. Anagliptin, another DPP-4 inhibitor, was shown to decrease low-density lipoprotein cholesterol (LDL-C) level to a greater extent than that by sitagliptin in the Randomized Evaluation of Anagliptin vs. Sitagliptin On low-density lipoproteiN cholesterol in diabetes (REASON) trial.
AIM AND METHODS


As a sub-analysis study using data obtained from the REASON trial, we investigated the effects of treatment with anagliptin (n = 148, male/female: 89/59) and treatment with sitagliptin (n = 159, male/female: 93/66) for 52 weeks on FABP4 concentration in patients with type 2 diabetes mellitus at a high risk for cardiovascular events who were receiving statin therapy.
RESULTS


The DPP-4 inhibitor had been administered in 82% of the patients in the anagliptin group and 81% of the patients in sitagliptin group prior to randomization. Serum FABP4 level was significantly decreased by 7.9% by treatment with anagliptin (P = 0.049) and was not significantly decreased by treatment with sitagliptin (P = 0.660). Change in FABP4 level was independently associated with basal FABP4 level and changes in waist circumference and creatinine after adjustment of age, sex and the treatment group.
CONCLUSION


Anagliptin decreases serum FABP4 concentration independent of change in hemoglobin A1c or LDL-C in patients with type 2 diabetes mellitus and dyslipidemia who are on statin therapy. Trial registration ClinicalTrials.gov number NCT02330406. Registered January 5, 2015, https://clinicaltrials.gov/ct2/show/NCT02330406.",2020,Anagliptin decreases serum FABP4 concentration independent of change in hemoglobin A1c or LDL-C in patients with type 2 diabetes mellitus and dyslipidemia who are on statin therapy.,"['patients with type 2 diabetes mellitus at a high risk for cardiovascular disease who are receiving statin therapy', 'patients with type 2 diabetes mellitus and dyslipidemia who are on statin therapy', 'n\u2009=\u2009148, male/female: 89/59) and treatment with sitagliptin (n\u2009=\u2009159, male/female: 93/66) for 52\xa0weeks on FABP4 concentration in patients with type 2 diabetes mellitus at a high risk for cardiovascular events who were receiving statin therapy', 'treated patients with type 2 diabetes mellitus']","['anagliptin, a DPP-4 inhibitor', 'Dipeptidyl peptidase-4 (DPP-4) inhibitors', 'Anagliptin vs. Sitagliptin', 'anagliptin', 'sulfonylurea']","['basal FABP4 level and changes in waist circumference and creatinine', 'serum FABP4 concentration', 'low-density lipoprotein cholesterol (LDL-C) level', 'FABP4 level', 'Serum FABP4 level', 'FABP4 concentration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1312689', 'cui_str': 'FABP4 protein, human'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C3272640', 'cui_str': 'anagliptin'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}, {'cui': 'C0081937', 'cui_str': 'Dipeptidyl peptidase IV'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C1312689', 'cui_str': 'FABP4 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}]",,0.0896455,Anagliptin decreases serum FABP4 concentration independent of change in hemoglobin A1c or LDL-C in patients with type 2 diabetes mellitus and dyslipidemia who are on statin therapy.,"[{'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Furuhashi', 'Affiliation': 'Department of Cardiovascular, Renal and Metabolic Medicine, Sapporo Medical University School of Medicine, South 1, West 16, Sapporo, 060-8543, Japan. furuhasi@sapmed.ac.jp.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Sakuma', 'Affiliation': 'Caress Sapporo Hokko Memorial Clinic, Sapporo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Morimoto', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Yukimura', 'Initials': 'Y', 'LastName': 'Higashiura', 'Affiliation': 'Department of Cardiovascular, Renal and Metabolic Medicine, Sapporo Medical University School of Medicine, South 1, West 16, Sapporo, 060-8543, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Sakai', 'Affiliation': 'Department of Cardiovascular, Renal and Metabolic Medicine, Sapporo Medical University School of Medicine, South 1, West 16, Sapporo, 060-8543, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Cardiovascular, Renal and Metabolic Medicine, Sapporo Medical University School of Medicine, South 1, West 16, Sapporo, 060-8543, Japan.'}, {'ForeName': 'Mio', 'Initials': 'M', 'LastName': 'Sakuma', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Shimabukuro', 'Affiliation': 'Department of Diabetes, Endocrinology and Metabolism, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Nomiyama', 'Affiliation': 'Department of Diabetes, Metabolism and Endocrinology, International University of Health and Welfare Ichikawa Hospital, Ichikawa, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Arasaki', 'Affiliation': 'Department of Cardiology, Tomishiro Central Hospital, Tomigusuku, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Node', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Ueda', 'Affiliation': 'Department of Pharmacology and Therapeutics, University of the Ryukyus, Nishihara, Japan.'}]",Cardiovascular diabetology,['10.1186/s12933-020-01061-0']
2390,32539847,Clinical outcomes and hemodynamic performance of Dafodil™ aortic and mitral pericardial bioprosthesis: 1-year results from Dafodil-1 first-in-human trial.,"BACKGROUND


Bioprosthesis has been increasingly implanted for the treatment of transvalvular disease across the world. A new Dafodil™ pericardial bioprosthesis (Meril Life Sciences Pvt. Ltd., India) recently approved by Conformité Européenne (CE) is a tri-leaflet, stented, bovine valve. The purpose of Dafodil-1 first-in-human trial was to evaluate clinical safety and performance (including hemodynamic parameters) of the Dafodil pericardial bioprosthesis in patients who underwent aortic or mitral valve replacement.
METHODS


This prospective, multicenter clinical trial enrolled 60 patients (Aortic: 30 patients; Mitral: 30 patients) from seven sites across India. Safety endpoints were early (≤30 days) and late (> 30 days) mortality and valve-related morbidity. The performance endpoints were hemodynamic performance, improvement in NYHA functional class, and change in the quality of life using SF-12v1 health survey.
RESULTS


From July 2017 to July 2018, 60 patients underwent implantation of the Dafodil pericardial bioprosthesis. Post-operatively, NYHA functional class significantly improved in all the patients (Aortic: 90% NYHA class-I and 10% NYHA class-II; Mitral: 96.55% NYHA class-I and 3.45% NYHA class-II; P < 0.001). There was no death in aortic valve replacement patients till 12-month. In mitral valve replacement patients, early mortalities occurred in three patients, and late mortality occurred in one patient; none of these were valve-related. Freedom from all-cause mortality reported was 93.33% at 12-month. Mean aortic pressure gradient decreased from 52.71 ± 24.47 mmHg [with 0.89 ± 0.70 cm 2  effective orifice area (EOA)] pre-operatively to 14.49 ± 6.58 mmHg (EOA: 1.85 ± 0.27 cm 2 ) at 12-month. Overall, the mitral mean pressure gradient and EOA were 4.41 ± 1.69 mmHg and 2.67 ± 0.48 cm 2 , respectively, at 12-month. Significant improvement (P < 0.05) in the patients' quality of life was reported at all follow-ups.
CONCLUSIONS


The clinical safety and performance of the Dafodil pericardial bioprosthesis were favourable at 12-month. Moreover, a study with a larger patient population and longer follow-up is warranted to further assess the device.
TRIAL REGISTRATION


Dafodil-1 trial has been prospectively registered on 10/07/2017 under Clinical Trial Registry-India (http://www.ctri.nic.in). (Registration number: CTRI/2017/07/009008).",2020,"Significant improvement (P < 0.05) in the patients' quality of life was reported at all follow-ups.
","['patients who underwent aortic or mitral valve replacement', 'From July 2017 to July 2018, 60 patients underwent implantation of the Dafodil pericardial bioprosthesis', '60 patients (Aortic: 30 patients; Mitral: 30 patients) from seven sites across India']","['Dafodil pericardial bioprosthesis', 'Dafodil™ aortic and mitral pericardial bioprosthesis']","['quality of life', 'hemodynamic performance, improvement in NYHA functional class, and change in the quality of life using SF-12v1 health survey', 'clinical safety and performance of the Dafodil pericardial bioprosthesis', 'late mortality', 'death', 'Mean aortic pressure gradient', 'mitral mean pressure gradient and EOA', 'late (>\u200930\u2009days) mortality and valve-related morbidity', 'early mortalities']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0026268', 'cui_str': 'Replacement of mitral valve'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0442031', 'cui_str': 'Pericardial'}, {'cui': 'C0005557', 'cui_str': 'Bioprosthesis'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0442031', 'cui_str': 'Pericardial'}, {'cui': 'C0005557', 'cui_str': 'Bioprosthesis'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442031', 'cui_str': 'Pericardial'}, {'cui': 'C0005557', 'cui_str': 'Bioprosthesis'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3494283', 'cui_str': 'Mean Aortic Pressure'}, {'cui': 'C0445074', 'cui_str': 'Mean pressure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",60.0,0.040517,"Significant improvement (P < 0.05) in the patients' quality of life was reported at all follow-ups.
","[{'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Hiremath', 'Affiliation': 'Department of Cardiothoracic Vascular Surgery, Sri Sathya Sai Institute of Higher Medical Sciences, Whitefield, Bengaluru, Karnataka, 560066, India.'}, {'ForeName': 'Anil R', 'Initials': 'AR', 'LastName': 'Jain', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, Epic Hospital, Sola, Ahmedabad, Gujarat, 380081, India.'}, {'ForeName': 'Anurag', 'Initials': 'A', 'LastName': 'Garg', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, Dr. D. Y. Patil Medical College, Hospital & Research Centre, Pimpri, Pune, Maharashtra, 411018, India.'}, {'ForeName': 'Nirmal', 'Initials': 'N', 'LastName': 'Gupta', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Raebareli Road, Lucknow, Uttar Pradesh, 226014, India.'}, {'ForeName': 'Yugal K', 'Initials': 'YK', 'LastName': 'Mishra', 'Affiliation': 'Department of Cardiac Science, Manipal Hospital, Dwarka, New Delhi, 110075, India.'}, {'ForeName': 'Zile Singh', 'Initials': 'ZS', 'LastName': 'Meharwal', 'Affiliation': 'Department of Cardiovascular Surgery, Fortis Escorts Heart Institute & Research Centre, Okhla Road, New Delhi, 110025, India.'}, {'ForeName': 'Nityanand', 'Initials': 'N', 'LastName': 'Thakur', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, Byramjee Jeejeebhoy Government Medical College and Sassoon General Hospitals, Jay Prakash Narayan road, Pune, Maharashtra, 411001, India.'}, {'ForeName': 'Atul A', 'Initials': 'AA', 'LastName': 'Maslekar', 'Affiliation': 'Department of Cardiac Surgery - Adult, Narayana Multispeciality Hospital, Rakhial, Ahmedabad, Gujarat, 380023, India.'}, {'ForeName': 'Naman', 'Initials': 'N', 'LastName': 'Shastri', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Epic Hospital, Sola, Sarkhej - Gandhinagar Highway, Opp. Kargil Petrol Pump, Ahmedabad, Gujarat, 380081, India. nashastri@gmail.com.'}]",Journal of cardiothoracic surgery,['10.1186/s13019-020-01154-7']
2391,32539908,An evaluation of factors influencing response to epicutaneous immunotherapy for peanut allergy in the PEPITES trial.,"BACKGROUND


Epicutaneous immunotherapy (EPIT) for peanut allergy is a potential novel immunotherapy that utilizes the unique cutaneous immunologic properties to induce desensitization. A randomized, double-blind, placebo-controlled Phase 3 trial (PEPITES) in peanut-allergic children 4-11 years demonstrated an epicutaneous patch (DBV712) with 250 micrograms peanut protein was statistically superior to placebo in inducing desensitization following 12 months of daily treatment.
OBJECTIVE


To investigate what baseline and in-study factors influenced response to DBV712 250 micrograms, with a focus on patch adhesion, by posthoc analysis of PEPITES data.
METHODS


A posthoc multivariate model built with log-transformed Month 12 eliciting dose (ED) as the dependent variable was used to assess the influence of baseline characteristics and patch adhesion. Baseline characteristics and treatment responsewere also evaluated by stratifying subjects into decile subgroups by patch detachment rates over the 12-month study.
RESULTS


Multivariate analysis identified higher baseline ED and lower baseline peanut-specific IgE as the variables mostpredictive of higher Month 12 ED, followed by mean daily patch application duration, baseline SCORing Atopic Dermatitis(SCORAD) score, and age. By decile stratification, no association between patch detachment and treatment response wasidentified for 80% of DBV712-treated subjects. All DBV712-treated subjects, including those with the highest patch detachment rates, demonstrated treatment benefit measured by fold-changes in geometric mean ED.
CONCLUSION


We identified subject baseline characteristics of higher baseline ED and lower baseline peanut-specific IgE asmost predictive of higher Month 12 ED. For the majority of treated subjects, patch detachment did not impact treatmentresponse. A minority of subjects, highly sensitive to peanut at baseline, had lower prespecified responder rates and higherpatch detachment rates, yet still benefited from treatment based upon fold-changes in ED.",2020,"By decile stratification, no association between patch detachment and treatment response wasidentified for 80% of DBV712-treated subjects.",['peanut-allergic children 4-11 years demonstrated an'],"['epicutaneous patch (DBV712) with 250 micrograms peanut protein', 'Epicutaneous immunotherapy (EPIT', 'epicutaneous immunotherapy', 'placebo']","['highest patch detachment rates', 'mean daily patch application duration, baseline SCORing Atopic Dermatitis(SCORAD) score, and age']","[{'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0541879', 'cui_str': 'Detachment psychological'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392707', 'cui_str': 'Atopy'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",,0.266158,"By decile stratification, no association between patch detachment and treatment response wasidentified for 80% of DBV712-treated subjects.","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Fleischer', 'Affiliation': ''}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Chinthrajah', 'Affiliation': ''}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Scurlock', 'Affiliation': ''}, {'ForeName': 'Dianne E', 'Initials': 'DE', 'LastName': 'Campbell', 'Affiliation': ''}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Green', 'Affiliation': ''}, {'ForeName': 'Katharine J', 'Initials': 'KJ', 'LastName': 'Bee', 'Affiliation': ''}, {'ForeName': 'Aurelie', 'Initials': 'A', 'LastName': 'Peillon', 'Affiliation': ''}, {'ForeName': 'Terrance', 'Initials': 'T', 'LastName': 'Ocheltree', 'Affiliation': ''}, {'ForeName': 'Hugh A', 'Initials': 'HA', 'LastName': 'Sampson', 'Affiliation': ''}]",Allergy and asthma proceedings,['10.2500/aap.2020.41.200047']
2392,32540088,Comparison of accommodations and interventions for youth with ADHD: A randomized controlled trial.,"School psychologists have a variety of evidence-based interventions from which to choose when recommending classroom-based strategies for students with attention deficit hyperactivity disorder (ADHD); however, strategies frequently found on individualized education plans are accommodations designed to remove barriers to learning, which have limited empirical evidence. As such, the purpose of the current study was to compare the efficacy of three interventions (i.e., organization training, self-management, note-taking instruction) and three accommodations (i.e., organization support, extended time, copy of teacher notes) to address difficulties with organization and maintaining attention during a science lesson and associated independent practice. The study included 64 middle school students with ADHD randomized to either an intervention or an accommodation condition. The intervention group was further divided into two subgroups, consisting of (a) students who were willing to follow intervention procedures and (b) students who were not willing to follow the procedures (behavioral indicators of social validity). Results indicated that adolescents with ADHD in the intervention group were statistically significantly more likely to organize and maintain binder organization and to take complete and accurate notes than those in the accommodation group. In addition, exploratory analyses indicated that adolescents who demonstrated willingness to follow intervention procedures were more likely to be academically engaged during instruction and independent work and to complete independent work accurately than those who resisted the procedures.",2020,Results indicated that adolescents with ADHD in the intervention group were statistically significantly more likely to organize and maintain binder organization and to take complete and accurate notes than those in the accommodation group.,"['students with attention deficit hyperactivity disorder (ADHD', 'youth with ADHD', '64 middle school students with ADHD randomized to either an']",['intervention or an accommodation condition'],['organize and maintain binder organization and to take complete and accurate notes'],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C1300196', 'cui_str': 'Organized'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0179302', 'cui_str': 'Binder'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",64.0,0.0302614,Results indicated that adolescents with ADHD in the intervention group were statistically significantly more likely to organize and maintain binder organization and to take complete and accurate notes than those in the accommodation group.,"[{'ForeName': 'Judith R', 'Initials': 'JR', 'LastName': 'Harrison', 'Affiliation': 'Rutgers, The State University of New Jersey, United States of America. Electronic address: judith.harrison@gse.rutgers.edu.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Evans', 'Affiliation': 'Ohio University, United States of America.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Baran', 'Affiliation': 'Rutgers, The State University of New Jersey, United States of America.'}, {'ForeName': 'Fairooz', 'Initials': 'F', 'LastName': 'Khondker', 'Affiliation': 'Rutgers, The State University of New Jersey, United States of America.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Press', 'Affiliation': 'Rutgers, The State University of New Jersey, United States of America.'}, {'ForeName': 'Daphney', 'Initials': 'D', 'LastName': 'Noel', 'Affiliation': 'Rutgers, The State University of New Jersey, United States of America.'}, {'ForeName': 'Shira', 'Initials': 'S', 'LastName': 'Wasserman', 'Affiliation': 'Rutgers, The State University of New Jersey, United States of America.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Belmonte', 'Affiliation': 'Rutgers, The State University of New Jersey, United States of America.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Mohlmann', 'Affiliation': 'Rutgers, The State University of New Jersey, United States of America.'}]",Journal of school psychology,['10.1016/j.jsp.2020.05.001']
2393,32540090,A cost-effectiveness analysis of classwide math intervention.,"Given limited resources, schools are encouraged to consider not only what works, but also at what cost. Cost-effectiveness analysis offers a formal methodology to conceptualize and calculate the ratio of the costs to implement an intervention to its effects (i.e., incremental cost-effectiveness ratios). This study used the ingredients method to analyze secondary data from a randomized controlled trial (N = 537 fourth- and fifth-grade students) to calculate the cost-effectiveness of a classwide math intervention, and provides an overview of cost-effectiveness analysis for readers unfamiliar with the formal methodology. For fourth-graders, the incremental cost-effectiveness ratio was $169.07, indicating it cost $169.07 per student for a 1 standard deviation increase in scaled scores on the state assessment. For fifth-graders, there was no statistically significant effect on the state assessment, but there were improvements in curriculum-based measurement (CBM) scores with incremental cost-effectiveness ratios ranging from $65.08 to $469.12, depending on the type of CBM probe and implementation context. Additionally, using number-needed-to-treat (i.e., the number of participants who must be provided with the intervention to prevent one failure on the state assessment), the cost was $126.90 to prevent failure on the state assessment for one fourth-grade student receiving special education services or for one student who scored below the 25th percentile on the prior year's state assessment. Implications and directions for future research are discussed.",2020,"For fifth-graders, there was no statistically significant effect on the state assessment, but there were improvements in curriculum-based measurement (CBM) scores with incremental cost-effectiveness ratios ranging from $65.08 to $469.12, depending on the type of CBM probe and implementation context.","['N\xa0=\xa0537 fourth- and fifth-grade students', 'readers unfamiliar with the formal methodology']",['classwide math intervention'],"['incremental cost-effectiveness ratio', 'curriculum-based measurement (CBM) scores with incremental cost-effectiveness ratios']","[{'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0969625', 'cui_str': 'methodology'}]","[{'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",537.0,0.0291837,"For fifth-graders, there was no statistically significant effect on the state assessment, but there were improvements in curriculum-based measurement (CBM) scores with incremental cost-effectiveness ratios ranging from $65.08 to $469.12, depending on the type of CBM probe and implementation context.","[{'ForeName': 'Courtenay A', 'Initials': 'CA', 'LastName': 'Barrett', 'Affiliation': 'Michigan State University, United States of America. Electronic address: morsicou@msu.edu.'}, {'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'VanDerHeyden', 'Affiliation': 'Education Research and Consulting, United States of America.'}]",Journal of school psychology,['10.1016/j.jsp.2020.04.002']
2394,32540134,Event-related Desynchronization of Alpha and Beta Band Neural Oscillations Predict Speech and Limb Motor Timing Deficits in Normal Aging.,"Normal aging is associated with decline of motor timing mechanisms implicated in planning and execution of movement. Evidence from previous studies has highlighted the relationship between neural oscillatory activities and motor timing processing in neurotypical younger adults; however, it remains unclear how normal aging affects the underlying neural mechanisms of movement in older populations. In the present study, we recorded EEG activities in two groups of younger and older adults while they performed randomized speech and limb motor reaction time tasks cued by temporally predictable and unpredictable sensory stimuli. Our data showed that older adults were significantly slower than their younger counterparts during speech production and limb movement, especially in response to temporally unpredictable sensory stimuli. This behavioral effect was accompanied by significant desynchronization of alpha (7-12 Hz) and beta (13-25 Hz) band neural oscillatory activities in older compared with younger adults, primarily during the preparatory pre-motor phase of responses for speech production and limb movement. In addition, we found that faster motor reaction times in younger adults were significantly correlated with weaker desynchronization of pre-motor alpha and beta band neural activities irrespective of stimulus timing and response modality. However, the pre-motor components of alpha and beta activities were timing-specific in older adults and were more strongly desynchronized in response to temporally predictable sensory stimuli. These findings highlight the role of alpha and beta band neural oscillations in motor timing processing mechanisms and reflect their functional deficits during the planning phase of speech production and limb movement in normal aging.",2020,"Our data showed that older adults were significantly slower than their younger counterparts during speech production and limb movement, especially in response to temporally unpredictable sensory stimuli.","['Normal Aging', 'neurotypical younger adults', 'two groups of younger and older adults', 'older adults']",['randomized speech and limb motor reaction time tasks cued by temporally predictable and unpredictable sensory stimuli'],['faster motor reaction times'],"[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",,0.0320888,"Our data showed that older adults were significantly slower than their younger counterparts during speech production and limb movement, especially in response to temporally unpredictable sensory stimuli.","[{'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Johari', 'Affiliation': 'Speech Neuroscience lab, Department of Communication Sciences and Disorders, University of South Carolina, Columbia, SC, United States; Department of Psychology, University of South Carolina, Columbia, SC, United States.'}, {'ForeName': 'Roozbeh', 'Initials': 'R', 'LastName': 'Behroozmand', 'Affiliation': 'Speech Neuroscience lab, Department of Communication Sciences and Disorders, University of South Carolina, Columbia, SC, United States. Electronic address: r-behroozmand@sc.edu.'}]",Behavioural brain research,['10.1016/j.bbr.2020.112763']
2395,32540150,Sleeve gastrectomy and Roux-en-Y gastric bypass in the treatment of type 2 diabetes. Two-year results from a Swedish multicenter randomized controlled trial.,"BACKGROUND


Obesity is a world-wide epidemic and it is a risk factor for type 2 diabetes (T2D). Few randomized controlled studies have compared the 2 most common surgical procedures, Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) in the treatment of obese patients with T2D.
OBJECTIVES


To compare diabetes remission rates (glycosylated hemoglobin ≤6.0%, without diabetes medications) in obese T2D patients (body mass index, 35-50) undergoing RYGB or SG.
SETTING


Three University Hospital clinics and 1 Regional Hospital in Sweden.
METHODS


Forty-nine patients with T2D were included. Twenty-five were randomized to RYGB and 24 to SG. There was no difference between groups regarding patient characteristics, duration of T2D, overall usage of antidiabetic medications, or glycosylated hemoglobin levels. All patients (100%) completed 1-year follow-up and 47 (95.9%) 2-year follow-up.
RESULTS


Remission of T2D was not significantly different between the RYGB and SG, reaching 44% and 46% (n = 25 and n = 24, respectively, P = .897, power = .80) at 1 year, and 48% and 55% (n = 25 and n = 22, respectively, P = .654) at 2 years of follow-up. Similarly, mean glycosylated hemoglobin was improved in both groups at 1 and 2 years, with no significant differences between the groups (RYGB baseline versus 1 yr; mean ± standard deviation: 7.9 ± 1.5 versus 5.8 ± .6%, P < .0001; versus 2 yr: 5.9 ± .7%, P < .0001; SG baseline versus 1 yr: 8.2 ± 1.9 versus 5.9 ± .7%, P < .0001; versus 2 yr: 5.9 ± 1.1%, P < .0001). Total weight loss was not different but percentage excess weight loss was higher after RYGB compared with SG both at 1 and 2 years; mean ± standard deviation: 78 ± 22 versus 60 ± 22%, and 76 ± 24 versus 54 ± 21%, respectively (P < .01 for both). Waist circumference also decreased significantly more in the RYGB group.
CONCLUSIONS


Despite superior excess weight loss after RYGB, T2D remission rates did not differ significantly between RYGB and SG after 2 years. Long-term follow-up data are needed to define the role of SG in the treatment of patients with obesity and T2D.",2020,"RESULTS


Remission of T2D was not significantly different between the RYGB and SG, reaching 44% and 46% (n = 25 and n = 24, respectively, P = .897, power = .80) at 1 year, and 48% and 55% (n = 25 and n = 22, respectively, P = .654) at 2 years of follow-up.","['patients with obesity and T2D', 'obese patients with T2D', 'obese T2D patients (body mass index, 35-50) undergoing RYGB or SG', 'Forty-nine patients with T2D were included', 'Twenty-five were randomized to RYGB and 24 to SG', 'type 2 diabetes', 'Three University Hospital clinics and 1 Regional Hospital in Sweden']","['Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG', 'Sleeve gastrectomy and Roux-en-Y gastric bypass']","['Waist circumference', 'Total weight loss', 'T2D remission rates', 'mean glycosylated hemoglobin', 'patient characteristics, duration of T2D, overall usage of antidiabetic medications, or glycosylated hemoglobin levels', 'Remission of T2D', 'diabetes remission rates', 'weight loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}]","[{'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017853', 'cui_str': 'Glycosylated hemoglobin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]",49.0,0.0638498,"RESULTS


Remission of T2D was not significantly different between the RYGB and SG, reaching 44% and 46% (n = 25 and n = 24, respectively, P = .897, power = .80) at 1 year, and 48% and 55% (n = 25 and n = 22, respectively, P = .654) at 2 years of follow-up.","[{'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Wallenius', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital Östra, University of Gothenburg, Gothenburg, Sweden. Electronic address: ville.wallenius@gastro.gu.se.'}, {'ForeName': 'Aiham', 'Initials': 'A', 'LastName': 'Alaraj', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Niclas', 'Initials': 'N', 'LastName': 'Björnfot', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Orrenius', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Kylebäck', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Björklund', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital Östra, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Werling', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Thorell', 'Affiliation': 'Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, Stockholm, Sweden; Department of Surgery, Ersta Hospital, Stockholm, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Fändriks', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Almantas', 'Initials': 'A', 'LastName': 'Maleckas', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden; Department of Surgery, Medical Academy, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}]",Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery,['10.1016/j.soard.2020.04.033']
2396,32546430,Newborn screening alone insufficient to improve pulmonary outcomes for cystic fibrosis.,"BACKGROUND


The Wisconsin Cystic Fibrosis Neonatal Screening Project was a randomized clinical trial (RCT) revealing that children receiving an early diagnosis of CF via newborn screening (NBS) had improved nutritional outcomes but similar lung disease severity compared to those who presented clinically. Because the evaluations of these subjects by protocol ended in 2012, our objective was to assess long-term pulmonary and mortality outcomes.
METHODS


Retrospective analysis of the RCT cohort utilized longitudinal outcome measures obtained from the Cystic Fibrosis Foundation Patient Registry (CFFPR). Data included screening assignment, clinical characteristics, percent predicted forced expiratory volume in 1 s (ppFEV 1 ) and mortality. A random intercept model was used to compare the ppFEV 1  decline of subjects between the two groups up to age 26 years. Mortality was analyzed using the Kaplan-Meier method.
RESULTS


Of the 145 subjects who consented to the original study, 104 subjects met inclusion criteria and had adequate data in the CFFPR. Of 57 subjects in the screened group and 47 in the control group, the rates of ppFEV 1  decline were 1.76%/year (95% CI 1.62 to 1.91%) and 1.43%/year (95% CI 1.26 to 1.60%), respectively (p<0.0002). Pseudomonas aeruginosa acquired before 2 years was partially responsible. There was no difference in mortality between the two groups.
CONCLUSIONS


NBS alone does not improve pulmonary outcomes in CF, particularly when other risk factors supervene. In an era prior to strict infection control and current therapies, NBS for CF may be associated with worse pulmonary outcomes.",2020,"There was no difference in mortality between the two groups.
","['cystic fibrosis', '145 subjects who consented to the original study', '104 subjects met inclusion criteria and had adequate data in the CFFPR', 'children receiving an early diagnosis of CF via newborn screening (NBS', 'subjects between the two groups up to age 26 years']",['Newborn screening alone insufficient'],"['forced expiratory volume in 1\xa0s (ppFEV 1 ) and mortality', 'mortality', 'Mortality', 'rates of ppFEV 1  decline', 'pulmonary outcomes']","[{'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0596473', 'cui_str': 'Early Diagnosis'}, {'cui': 'C0027617', 'cui_str': 'Neonatal screening'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0027617', 'cui_str': 'Neonatal screening'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}]","[{'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0618434,"There was no difference in mortality between the two groups.
","[{'ForeName': 'Christina B', 'Initials': 'CB', 'LastName': 'Barreda', 'Affiliation': 'Department of Pediatrics, University of Wisconsin-Madison School of Medicine and Public Health, 600 Highland Ave, Madison, WI 53792, USA. Electronic address: cbarreda@wisc.edu.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Farrell', 'Affiliation': 'Department of Pediatrics, University of Wisconsin-Madison School of Medicine and Public Health, 600 Highland Ave, Madison, WI 53792, USA. Electronic address: pmfarrell@wisc.edu.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Laxova', 'Affiliation': 'Department of Pediatrics, University of Wisconsin-Madison School of Medicine and Public Health, 600 Highland Ave, Madison, WI 53792, USA. Electronic address: alaxova@pediatrics.wisc.edu.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Eickhoff', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison School of Medicine and Public Health, 600 Highland Ave, Madison, WI 53792, USA. Electronic address: eickhoff@biostat.wisc.edu.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Braun', 'Affiliation': 'Department of Medicine, University of Wisconsin-Madison School of Medicine and Public Health, 600 Highland Ave, Madison, WI 53792, USA. Electronic address: atbraun@medicine.wisc.edu.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Coller', 'Affiliation': 'Department of Pediatrics, University of Wisconsin-Madison School of Medicine and Public Health, 600 Highland Ave, Madison, WI 53792, USA. Electronic address: rcoller@pediatrics.wisc.edu.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Rock', 'Affiliation': 'Department of Pediatrics, University of Wisconsin-Madison School of Medicine and Public Health, 600 Highland Ave, Madison, WI 53792, USA. Electronic address: mjrock@wisc.edu.'}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2020.06.002']
2397,32546431,Tezacaftor/ivacaftor in people with cystic fibrosis heterozygous for minimal function CFTR mutations.,"BACKGROUND


Tezacaftor/ivacaftor is a CFTR modulator approved to treat people with cystic fibrosis (pwCF) who are homozygous (F/F) or heterozygous for the F508del-CFTR mutation and a residual function mutation (F/RF). This randomized, double-blind, placebo-controlled Phase 3 study evaluated the efficacy, safety, tolerability, and pharmacokinetics (PK) of tezacaftor/ivacaftor in participants ≥12 years of age heterozygous for the F508del-CFTR mutation and a minimal function mutation (F/MF), which produces no CFTR protein or a protein unresponsive to tezacaftor/ivacaftor in vitro.
METHODS


Participants were randomized 1:1 to receive tezacaftor/ivacaftor or placebo for 12 weeks. The primary endpoint was the absolute change from baseline in percent predicted forced expiratory volume in 1 second (ppFEV 1 ) between the tezacaftor/ivacaftor and placebo groups through week 12. Key secondary endpoints included absolute change from baseline in CF Questionnaire-Revised respiratory domain scores and the number of pulmonary exacerbations through week 12 and the absolute change from baseline in body mass index at week 12. A prespecified interim analysis (IA) for futility was conducted when approximately 50% of a planned enrollment of 300 participants reached week 12 of the study.
RESULTS


At the time of the IA, 83 participants were randomized to tezacaftor/ivacaftor and 85 to placebo; 165 participants completed treatment. The study failed to demonstrate that tezacaftor/ivacaftor significantly improved ppFEV 1  or any of the key secondary endpoints and was terminated for futility. The safety profile and PK parameters of tezacaftor/ivacaftor were similar to those reported in prior studies in participants ≥12 years of age with CF.
CONCLUSIONS


Tezacaftor/ivacaftor did not show a clinically meaningful benefit in participants with F/MF genotypes but was generally safe and well tolerated, consistent with the safety profile reported in other Phase 3 studies (NCT02516410).",2020,The study failed to demonstrate that tezacaftor/ivacaftor significantly improved ppFEV 1  or any of the key secondary endpoints and was terminated for futility.,"['165 participants completed treatment', 'participants ≥12 years of age with CF', 'people with cystic fibrosis ', 'Participants', '83 participants', '300 participants reached week 12 of the study', 'participants ≥12 years of age heterozygous for the F508del-CFTR mutation and a minimal function mutation (F/MF), which produces no CFTR protein or a protein unresponsive to tezacaftor/ivacaftor in vitro', 'people with cystic fibrosis heterozygous for minimal function CFTR mutations']","['pwCF', 'tezacaftor/ivacaftor or placebo', 'tezacaftor/ivacaftor', 'Tezacaftor/ivacaftor', 'placebo']","['efficacy, safety, tolerability, and pharmacokinetics (PK', 'safety profile and PK parameters of tezacaftor/ivacaftor', 'absolute change from baseline in CF Questionnaire-Revised respiratory domain scores and the number of pulmonary exacerbations', 'absolute change from baseline in percent predicted forced expiratory volume in 1\xa0second (ppFEV 1 ', 'safe and well tolerated']","[{'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0019425', 'cui_str': 'Heterozygote'}, {'cui': 'C0056889', 'cui_str': 'CFTR Protein'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0038164', 'cui_str': 'Protein A'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C4519194', 'cui_str': 'tezacaftor'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C4519194', 'cui_str': 'tezacaftor'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4519194', 'cui_str': 'tezacaftor'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0730561', 'cui_str': 'Percent predicted FEV1'}]",83.0,0.465593,The study failed to demonstrate that tezacaftor/ivacaftor significantly improved ppFEV 1  or any of the key secondary endpoints and was terminated for futility.,"[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Munck', 'Affiliation': 'Robert Debré Hospital, Assistance Publique-Hopitaux de Paris, Université Paris Diderot, Paris, France. Electronic address: anne.munck1@gmail.com.'}, {'ForeName': 'Eitan', 'Initials': 'E', 'LastName': 'Kerem', 'Affiliation': 'Department of Pediatrics and Cystic Fibrosis Center, Hadassah-Hebrew University Medical Center, Mount Scopus, Jerusalem, Israel. Electronic address: eitank@hadassah.org.il.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Ellemunter', 'Affiliation': 'Department of Child and Adolescent Health, Division of Cardiology, Pulmonology, Allergology, and Cystic Fibrosis, Cystic Fibrosis Centre, Medical University of Innsbruck, Innsbruck, Austria. Electronic address: helmut.ellemunter@i-med.ac.at.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Campbell', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, MA, USA. Electronic address: Daniel_Campbell@vrtx.com.'}, {'ForeName': 'Linda T', 'Initials': 'LT', 'LastName': 'Wang', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, MA, USA. Electronic address: Linda_Wang@vrtx.com.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Ahluwalia', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, MA, USA. Electronic address: Neil_Ahluwalia@vrtx.com.'}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Owen', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, MA, USA. Electronic address: Caroline_Owen@vrtx.com.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Wainwright', 'Affiliation': 'Faculty of Medicine, University of Queensland, South Brisbane, Queensland, Australia. Electronic address: claire.wainwright@health.qld.gov.au.'}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2020.04.015']
2398,32546477,Paramedic experiences of using an enhanced stroke assessment during a cluster randomised trial: a qualitative thematic analysis.,"BACKGROUND


Intravenous thrombolysis is a key element of emergency treatment for acute ischaemic stroke, but hospital service delivery is variable. The Paramedic Acute Stroke Treatment Assessment (PASTA) multicentre cluster randomised controlled trial evaluated whether an enhanced paramedic-initiated stroke assessment pathway could improve thrombolysis volume. This paper reports the findings of a parallel process evaluation which explored intervention paramedics' experience of delivering the enhanced assessment.
METHODS


Interviewees were recruited from 453 trained intervention paramedics across three UK ambulance services hosting the trial: North East, North West and Welsh Ambulance Services. A semistructured interview guide aimed to (1) explore the stroke-specific assessment and handover procedures which were part of the PASTA pathway and (2) enable paramedics to share relevant views about expanding their role and any barriers/enablers they encountered. Interviews were audiorecorded, transcribed verbatim and analysed following the principles of the constant comparative method.
RESULTS


Twenty-six interviews were conducted (11 North East, 10 North West and 5 Wales). Iterative data analysis identified four key themes, which reflected paramedics' experiences at different stages of the care pathway: (1) Enhanced assessment at scene: paramedics felt this improved their skillset and confidence. (2) Prealert to hospital: a mixed experience dependent on receiving hospital staff. (3) Handover to hospital team: standardisation of format was viewed as the primary benefit of the PASTA pathway. (4) Assisting in hospital and feedback: due to professional boundaries, paramedics found these aspects harder to achieve, although feedback from the clinical team was valued when available.
CONCLUSION


Paramedics believed that the PASTA pathway enhanced their skills and the emergency care of stroke patients, but a continuing clinical role postadmission was challenging. Future studies should consider whether interdisciplinary training is needed to enable more radical extension of professional boundaries for paramedics.",2020,The Paramedic Acute Stroke Treatment Assessment (PASTA) multicentre cluster randomised controlled trial evaluated whether an enhanced paramedic-initiated stroke assessment pathway could improve thrombolysis volume.,"['Twenty-six interviews were conducted (11 North East, 10 North West and 5 Wales', 'Interviewees were recruited from 453 trained intervention paramedics across three UK ambulance services hosting the trial: North East, North West and Welsh Ambulance Services']",[],['thrombolysis volume'],"[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0002422', 'cui_str': 'Ambulance'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043114', 'cui_str': 'Welsh'}]",[],"[{'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",26.0,0.046024,The Paramedic Acute Stroke Treatment Assessment (PASTA) multicentre cluster randomised controlled trial evaluated whether an enhanced paramedic-initiated stroke assessment pathway could improve thrombolysis volume.,"[{'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Lally', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Vaittinen', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'McClelland', 'Affiliation': 'Research and Development, North East Ambulance Service NHS Foundation Trust, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'Christopher I', 'Initials': 'CI', 'LastName': 'Price', 'Affiliation': 'Stroke Research Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK c.i.m.price@ncl.ac.uk.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Shaw', 'Affiliation': 'Stroke Research Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Ford', 'Affiliation': 'Medical Sciences Division, University of Oxford, and Oxford University Hospitals NHS Foundation Trust, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Flynn', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Exley', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}]",Emergency medicine journal : EMJ,['10.1136/emermed-2019-209392']
2399,32546491,Randomised controlled trial assessing the effect of a technology-assisted gait and balance training on mobility in older people after hip fracture: study protocol.,"INTRODUCTION


Deficits in balance and walking ability are relevant risk factors for falls during ageing. Moreover, falls are a risk factor for future falls, strongly associated with adverse health outcomes, such as fear of falling or fractures, particularly, hip fracture. For this reason, the development of prevention tools and innovative rehabilitation strategies is one of the main objectives in geriatrics. Effective interventions to promote hip recovery after hip fracture are characterised by intensive and repetitive movements. One treatment approach is to increase the number of steps during the rehabilitation sessions and to improve the balance and the endurance of the patients in the use of technological devices.
METHODS AND ANALYSIS


This randomised controlled trial aimed to evaluate an innovative rehabilitation treatment of elderly patients with hip fractures. A total of 195 patients with hip fractures will be recruited and randomly divided into three groups: traditional rehabilitation programme, traditional rehabilitation programme plus TYMO system and traditional rehabilitation programme plus Walker View. Assessments will be performed at baseline, at the end of treatment, at 6 months, and at 1 and 2 years after the end of the treatment. Only subjects hospitalised 4 weeks prior to the beginning of the study will be taken into consideration. Twenty treatment sessions will be conducted, divided into three training sessions per week, for 7 weeks. The technological intervention group will carry out 30 min sessions of traditional therapy and 20 min of treatment with a technological device. The control group will perform traditional therapy sessions, each lasting 50 min. The primary outcomes are risk of falling, gait performance and fear of falling.
ETHICS AND DISSEMINATION


The study was approved by the Istituto di Ricerca e Cura a Carattere Scientifica, Istituto Nazionale Ricovero e Cura Anziani Ethics Committee, with identification code number 19 014. Trial results will be submitted for publication in journals and conferences.
TRIAL REGISTRATION NUMBER


NCT04095338.",2020,"Moreover, falls are a risk factor for future falls, strongly associated with adverse health outcomes, such as fear of falling or fractures, particularly, hip fracture.","['older people after hip fracture', '195 patients with hip fractures', 'elderly patients with hip fractures']","['innovative rehabilitation treatment', 'technology-assisted gait and balance training', 'traditional rehabilitation programme, traditional rehabilitation programme plus TYMO system and traditional rehabilitation programme plus Walker View']","['risk of falling, gait performance and fear of falling']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0043016', 'cui_str': 'Walker'}, {'cui': 'C0449911', 'cui_str': 'View'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}]",195.0,0.0345737,"Moreover, falls are a risk factor for future falls, strongly associated with adverse health outcomes, such as fear of falling or fractures, particularly, hip fracture.","[{'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Maranesi', 'Affiliation': 'Scientific Direction, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Giovanni Renato', 'Initials': 'GR', 'LastName': 'Riccardi', 'Affiliation': 'Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Fabrizia', 'Initials': 'F', 'LastName': 'Lattanzio', 'Affiliation': 'Scientific Direction, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Di Rosa', 'Affiliation': 'Unit of Geriatric Pharmacoepidemiology, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Luzi', 'Affiliation': 'Medical Direction, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Casoni', 'Affiliation': 'Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Rinaldi', 'Affiliation': 'Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Fermo, Italy.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Baldoni', 'Affiliation': 'Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Di Donna', 'Affiliation': 'Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Fermo, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Bevilacqua', 'Affiliation': 'Scientific Direction, IRCCS INRCA, Ancona, Italy r.bevilacqua@inrca.it.'}]",BMJ open,['10.1136/bmjopen-2019-035508']
2400,32546646,ESR1 mutations and overall survival on fulvestrant versus exemestane in advanced hormone receptor positive breast cancer: A combined analysis of the phase III SoFEA and EFECT trials.,"PURPOSE


ESR1  mutations are acquired frequently in hormone receptor positive (HR+) metastatic breast cancer after prior aromatase inhibitors (AI). We assessed the clinical utility of baseline  ESR1  circulating tumor DNA analysis in the two phase III randomised trials of fulvestrant versus exemestane.
PATIENTS AND METHODS


The phase III EFECT and SoFEA trials randomised patients with HR+ metastatic breast cancer who had progressed on prior non-steroidal AI, between fulvestrant 250mg and exemestane. Baseline serum samples from 227 patients in EFECT, and baseline plasma from 161 patients in SoFEA, were analysed for  ESR1 mutations by digital PCR. The primary objectives were to assess the impact of  ESR1  mutation status on progression-free and overall survival in a combined analysis of both studies.
RESULTS


ESR1  mutations were detected in 30% (151/383) baseline samples. In patients with  ESR1  mutation detected, PFS was 2.4 months (95%CI,2.0-2.6) on exemestane and 3.9 months (95%CI,3.0-6.0) on fulvestrant (HR=0.59, 95%CI,0.39-0.89; p=0.01). In patients without  ESR1  mutations detected, PFS was 4.8 months (95%CI,3.7-6.2) on exemestane and 4.1 months (95%CI,3.6-5.5) on fulvestrant (HR=1.05, 95%CI,0.81-1.37; p=0.69). There was an interaction between  ESR1  mutation and treatment (p=0.02). Patients with  ESR1  mutation detected had one-year overall survival of 62% (95%CI,45%-75%) on exemestane and 80% (95%CI,68%-87%) on fulvestrant (p=0.04, restricted mean survival analysis). Patients without  ESR1  mutations detected has one-year overall survival of 79% (95%CI,71%-85%) on exemestane and 81% (95%CI,74%-87%) on fulvestrant (p=0.69).
CONCLUSIONS


Detection of  ESR1  mutations in baseline ctDNA associated with inferior progression-free and overall survival in patients treated with exemestane versus fulvestrant.",2020,"In patients with  ESR1  mutation detected, PFS was 2.4 months (95%CI,2.0-2.6) on exemestane and 3.9 months (95%CI,3.0-6.0) on fulvestrant (HR=0.59, 95%CI,0.39-0.89; p=0.01).","['patients with HR+ metastatic breast cancer who had progressed on prior non-steroidal AI, between', '227 patients in EFECT, and baseline plasma from 161 patients in SoFEA', 'advanced hormone receptor positive breast cancer']","['fulvestrant 250mg and exemestane', 'exemestane', 'fulvestrant', 'fulvestrant versus exemestane', 'exemestane versus fulvestrant']","['one-year overall survival', 'PFS', 'ESR1 mutations and overall survival', 'inferior progression-free and overall survival', 'impact of  ESR1  mutation status on progression-free and overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}]","[{'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1521863', 'cui_str': 'estrogen receptor alpha, human'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.393116,"In patients with  ESR1  mutation detected, PFS was 2.4 months (95%CI,2.0-2.6) on exemestane and 3.9 months (95%CI,3.0-6.0) on fulvestrant (HR=0.59, 95%CI,0.39-0.89; p=0.01).","[{'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Turner', 'Affiliation': 'Breast Cancer Now Research Centre, Institute of Cancer Research and The Royal Marsden Hospital Nick.Turner@icr.ac.uk.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Swift', 'Affiliation': 'Ralph Lauren Breast Cancer Research Centre, Royal Marsden Hospital.'}, {'ForeName': 'Lucy S', 'Initials': 'LS', 'LastName': 'Kilburn', 'Affiliation': 'ICR Clinical Trials and Statistics Unit, Institute of Cancer Research.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Fribbens', 'Affiliation': 'Breast Cancer Now Research Centre, Institute of Cancer Research.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Beaney', 'Affiliation': 'Breast Cancer Now Research Centre, Institute of Cancer Research.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Garcia-Murillas', 'Affiliation': 'Breast Cancer Now Research Centre, Institute of Cancer Research and The Royal Marsden Hospital.'}, {'ForeName': 'Aman U', 'Initials': 'AU', 'LastName': 'Buzdar', 'Affiliation': 'Department of Breast Medical Oncology--1354, The University of Texas MD Anderson Cancer Center.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Roberston', 'Affiliation': 'Unit of surgery, University of Nottingham.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Gradishar', 'Affiliation': 'Department of Medicine, Northwestern University Feinberg School of Medicine.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Piccart', 'Affiliation': 'Universite Libre de Bruxelles, Jules Bordet Institute, Brussels.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Schiavon', 'Affiliation': 'IMED Biotech Unit, AstraZeneca.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Bliss', 'Affiliation': 'ICR-CTSU, Division of Clinical Studies, Institute of Cancer Research.'}, {'ForeName': 'Mitch', 'Initials': 'M', 'LastName': 'Dowsett', 'Affiliation': 'Ralph Lauren Centre for Breast Cancer Research, Royal Marsden Hospital.'}, {'ForeName': 'Stephen R D', 'Initials': 'SRD', 'LastName': 'Johnston', 'Affiliation': 'Breast Unit, Royal Marsden Hospital.'}, {'ForeName': 'Stephen K', 'Initials': 'SK', 'LastName': 'Chia', 'Affiliation': 'Dept of Medical Oncology, British Columbia Cancer Agency.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0224']
2401,32546648,Predictive value of molecular subtypes in premenopausal women with hormone receptor-positive early breast cancer: Results from the ABCSG Trial 5.,"PURPOSE


To assess the predictive value of molecular breast cancer subtypes in premenopausal hormone receptor-positive early breast cancer patients who received adjuvant endocrine treatment or chemotherapy.
EXPERIMENTAL DESIGN


Molecular breast cancer subtypes were centrally assessed on whole tumor sections by immunohistochemistry (IHC) in patients of the Austrian Breast and Colorectal Cancer Study Group (ABCSG) Trial 5 who had received either 5 years of tamoxifen/3 years of goserelin or six cycles of cyclophosphamide, methotrexate, and fluorouracil (CMF). Luminal A disease was defined as Ki67 <20%, luminal B as Ki67 ≥20%. The luminal B/HER2-positive subtype displayed 3+ HER2-IHC or amplification by ISH. Recurrence-free survival (RFS) and overall survival (OS) were analyzed using Cox models adjusted for clinical and pathological factors.
RESULTS


185 (38%), 244 (50%) and 59 (12%) of 488 tumors were classified as luminal A, luminal B/HER2-negative and luminal B/HER2-positive, respectively. Luminal B subtypes were associated with poor outcome. Patients with Luminal B tumors had a significantly shorter RFS (adjusted hazard ratio [HR] for recurrence: 2.22, 95% confidence interval [CI] 1.41-3.49, P = 0.001) and OS (adjusted HR for death: 3.51, 95% CI 1.80-6.87, P < 0.001). No interaction between molecular subtypes and treatment was observed (test for interaction: P = 0.84 for RFS; P = 0.69 for OS).
CONCLUSION


Determination of molecular subtypes by IHC is an independent prognostic factor for recurrence and death in premenopausal women with early-stage, hormone receptor-positive breast cancer but is not predictive for outcome of adjuvant treatment with tamoxifen/goserelin or CMF.",2020,"Patients with Luminal B tumors had a significantly shorter RFS (adjusted hazard ratio [HR] for recurrence: 2.22, 95% confidence interval [CI] 1.41-3.49, P = 0.001) and OS (adjusted HR for death: 3.51, 95% CI 1.80-6.87, P < 0.001).","['premenopausal hormone receptor-positive early breast cancer patients who received', 'premenopausal women with hormone receptor-positive early breast cancer', 'Trial 5 who had received either 5 years of tamoxifen/3 years of goserelin or six cycles of', 'premenopausal women with early-stage, hormone receptor-positive breast cancer', 'Molecular breast cancer subtypes were centrally assessed on whole tumor sections by immunohistochemistry (IHC) in patients of the Austrian Breast and Colorectal Cancer Study Group (ABCSG']","['tamoxifen/goserelin or CMF', 'adjuvant endocrine treatment or chemotherapy', 'cyclophosphamide, methotrexate, and fluorouracil (CMF']","['Luminal A disease', 'Recurrence-free survival (RFS) and overall survival (OS', 'shorter RFS']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0120107', 'cui_str': 'Goserelin'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0337795', 'cui_str': 'Austrians'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0120107', 'cui_str': 'Goserelin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]",488.0,0.183225,"Patients with Luminal B tumors had a significantly shorter RFS (adjusted hazard ratio [HR] for recurrence: 2.22, 95% confidence interval [CI] 1.41-3.49, P = 0.001) and OS (adjusted HR for death: 3.51, 95% CI 1.80-6.87, P < 0.001).","[{'ForeName': 'Zsuzsanna', 'Initials': 'Z', 'LastName': 'Bago-Horvath', 'Affiliation': 'Department of Pathology, Medical University of Vienna.'}, {'ForeName': 'Margaretha', 'Initials': 'M', 'LastName': 'Rudas', 'Affiliation': 'Department of Pathology, Medical University of Vienna.'}, {'ForeName': 'Christian F', 'Initials': 'CF', 'LastName': 'Singer', 'Affiliation': 'Department of OB/GYN and Comprehensive Cancer Center, Medical University of Vienna.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'Department of Internal Medicine III, Salzburg Cancer Research Institute - Laboratory for Immunological and Molecular Cancer Research (SCRI-LIMCR), Paracelsus Medical University Salzburg.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Balic', 'Affiliation': 'Departement, Medical University of Graz.'}, {'ForeName': 'Sigurd', 'Initials': 'S', 'LastName': 'Lax', 'Affiliation': 'Hospital Graz South-West.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Kwasny', 'Affiliation': 'Dept of Surgery, LKH Wiener Neustadt.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Hulla', 'Affiliation': 'Department of Pathology, Hospital Wiener Neustadt.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gnant', 'Affiliation': 'Comprehensive Cancer Center, Medical University of Vienna.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Filipits', 'Affiliation': 'Institute of Cancer Research, Department of Medicine I, Medical University of Vienna, Comprehensive Cancer Center martin.filipits@meduniwien.ac.at.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0673']
2402,32546652,Wisdom of the expert crowd prediction of response for 3 neurology randomized trials.,"OBJECTIVE


To explore the accuracy of combined neurology expert forecasts in predicting primary endpoints for trials.
METHODS


We identified one major randomized trial each in stroke, multiple sclerosis (MS), and amyotrophic lateral sclerosis (ALS) that was closing within 6 months. After recruiting a sample of neurology experts for each disease, we elicited forecasts for the primary endpoint outcomes in the trial placebo and treatment arms. Our main outcome was the accuracy of averaged predictions, measured using ordered Brier scores. Scores were compared against an algorithm that offered noncommittal predictions.
RESULTS


Seventy-one neurology experts participated. Combined forecasts of experts were less accurate than a noncommittal prediction algorithm for the stroke trial (pooled Brier score = 0.340, 95% subjective probability interval [sPI] 0.340 to 0.340 vs 0.185 for the uninformed prediction), and approximately as accurate for the MS study (pooled Brier score = 0.107, 95% confidence interval [CI] 0.081 to 0.133 vs 0.098 for the noncommittal prediction) and the ALS study (pooled Brier score = 0.090, 95% CI 0.081 to 0.185 vs 0.090). The 95% sPIs of individual predictions contained actual trial outcomes among 44% of experts. Only 18% showed prediction skill exceeding the noncommittal prediction. Independent experts and coinvestigators achieved similar levels of accuracy.
CONCLUSION


In this first-of-kind exploratory study, averaged expert judgments rarely outperformed noncommittal forecasts. However, experts at least anticipated the possibility of effects observed in trials. Our findings, if replicated in different trial samples, caution against the reliance on simple approaches for combining expert opinion in making research and policy decisions.",2020,"Combined forecasts of experts were less accurate than a noncommittal prediction algorithm for the stroke trial (pooled Brier score = 0.340, 95% subjective probability interval [sPI] 0.340 to 0.340 vs 0.185 for the uninformed prediction), and approximately as accurate for the MS study (pooled Brier score = 0.107, 95% confidence interval [CI] 0.081 to 0.133 vs 0.098 for the noncommittal prediction) and the ALS study (pooled Brier score = 0.090, 95% CI 0.081 to 0.185 vs 0.090).",['Seventy-one neurology experts participated'],['placebo'],[],"[{'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.395631,"Combined forecasts of experts were less accurate than a noncommittal prediction algorithm for the stroke trial (pooled Brier score = 0.340, 95% subjective probability interval [sPI] 0.340 to 0.340 vs 0.185 for the uninformed prediction), and approximately as accurate for the MS study (pooled Brier score = 0.107, 95% confidence interval [CI] 0.081 to 0.133 vs 0.098 for the noncommittal prediction) and the ALS study (pooled Brier score = 0.090, 95% CI 0.081 to 0.185 vs 0.090).","[{'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Atanasov', 'Affiliation': 'From Pytho LLC (P.A.), Brooklyn, NY; Department of Neurology (A.D.), Inselspital, Bern University Hospital, University of Bern, Switzerland; Biomedical Ethics Unit, Department of Social Studies of Medicine (A.M., E.V., D.M.B., J.K.), and Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital (I.S.), McGill University, Montreal, Canada; Max Delbrueck Center for Molecular Medicine (F.P.), Berlin; Department of Neurology (F.P.), NeuroCure Clinical Research Center and Experimental and Clinical Research Center, Charité-Universitätsmedizin Berlin; Humboldt-Universität zu Berlin (U.D.), Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin; and Department of Experimental Neurology and Center for Stroke Research Berlin and QUEST Center for Transforming Biomedical Research (U.D.), Berlin Institute of Health, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Diamantaras', 'Affiliation': 'From Pytho LLC (P.A.), Brooklyn, NY; Department of Neurology (A.D.), Inselspital, Bern University Hospital, University of Bern, Switzerland; Biomedical Ethics Unit, Department of Social Studies of Medicine (A.M., E.V., D.M.B., J.K.), and Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital (I.S.), McGill University, Montreal, Canada; Max Delbrueck Center for Molecular Medicine (F.P.), Berlin; Department of Neurology (F.P.), NeuroCure Clinical Research Center and Experimental and Clinical Research Center, Charité-Universitätsmedizin Berlin; Humboldt-Universität zu Berlin (U.D.), Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin; and Department of Experimental Neurology and Center for Stroke Research Berlin and QUEST Center for Transforming Biomedical Research (U.D.), Berlin Institute of Health, Germany.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'MacPherson', 'Affiliation': 'From Pytho LLC (P.A.), Brooklyn, NY; Department of Neurology (A.D.), Inselspital, Bern University Hospital, University of Bern, Switzerland; Biomedical Ethics Unit, Department of Social Studies of Medicine (A.M., E.V., D.M.B., J.K.), and Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital (I.S.), McGill University, Montreal, Canada; Max Delbrueck Center for Molecular Medicine (F.P.), Berlin; Department of Neurology (F.P.), NeuroCure Clinical Research Center and Experimental and Clinical Research Center, Charité-Universitätsmedizin Berlin; Humboldt-Universität zu Berlin (U.D.), Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin; and Department of Experimental Neurology and Center for Stroke Research Berlin and QUEST Center for Transforming Biomedical Research (U.D.), Berlin Institute of Health, Germany.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Vinarov', 'Affiliation': 'From Pytho LLC (P.A.), Brooklyn, NY; Department of Neurology (A.D.), Inselspital, Bern University Hospital, University of Bern, Switzerland; Biomedical Ethics Unit, Department of Social Studies of Medicine (A.M., E.V., D.M.B., J.K.), and Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital (I.S.), McGill University, Montreal, Canada; Max Delbrueck Center for Molecular Medicine (F.P.), Berlin; Department of Neurology (F.P.), NeuroCure Clinical Research Center and Experimental and Clinical Research Center, Charité-Universitätsmedizin Berlin; Humboldt-Universität zu Berlin (U.D.), Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin; and Department of Experimental Neurology and Center for Stroke Research Berlin and QUEST Center for Transforming Biomedical Research (U.D.), Berlin Institute of Health, Germany.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Benjamin', 'Affiliation': 'From Pytho LLC (P.A.), Brooklyn, NY; Department of Neurology (A.D.), Inselspital, Bern University Hospital, University of Bern, Switzerland; Biomedical Ethics Unit, Department of Social Studies of Medicine (A.M., E.V., D.M.B., J.K.), and Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital (I.S.), McGill University, Montreal, Canada; Max Delbrueck Center for Molecular Medicine (F.P.), Berlin; Department of Neurology (F.P.), NeuroCure Clinical Research Center and Experimental and Clinical Research Center, Charité-Universitätsmedizin Berlin; Humboldt-Universität zu Berlin (U.D.), Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin; and Department of Experimental Neurology and Center for Stroke Research Berlin and QUEST Center for Transforming Biomedical Research (U.D.), Berlin Institute of Health, Germany.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Shrier', 'Affiliation': 'From Pytho LLC (P.A.), Brooklyn, NY; Department of Neurology (A.D.), Inselspital, Bern University Hospital, University of Bern, Switzerland; Biomedical Ethics Unit, Department of Social Studies of Medicine (A.M., E.V., D.M.B., J.K.), and Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital (I.S.), McGill University, Montreal, Canada; Max Delbrueck Center for Molecular Medicine (F.P.), Berlin; Department of Neurology (F.P.), NeuroCure Clinical Research Center and Experimental and Clinical Research Center, Charité-Universitätsmedizin Berlin; Humboldt-Universität zu Berlin (U.D.), Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin; and Department of Experimental Neurology and Center for Stroke Research Berlin and QUEST Center for Transforming Biomedical Research (U.D.), Berlin Institute of Health, Germany.'}, {'ForeName': 'Friedemann', 'Initials': 'F', 'LastName': 'Paul', 'Affiliation': 'From Pytho LLC (P.A.), Brooklyn, NY; Department of Neurology (A.D.), Inselspital, Bern University Hospital, University of Bern, Switzerland; Biomedical Ethics Unit, Department of Social Studies of Medicine (A.M., E.V., D.M.B., J.K.), and Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital (I.S.), McGill University, Montreal, Canada; Max Delbrueck Center for Molecular Medicine (F.P.), Berlin; Department of Neurology (F.P.), NeuroCure Clinical Research Center and Experimental and Clinical Research Center, Charité-Universitätsmedizin Berlin; Humboldt-Universität zu Berlin (U.D.), Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin; and Department of Experimental Neurology and Center for Stroke Research Berlin and QUEST Center for Transforming Biomedical Research (U.D.), Berlin Institute of Health, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Dirnagl', 'Affiliation': 'From Pytho LLC (P.A.), Brooklyn, NY; Department of Neurology (A.D.), Inselspital, Bern University Hospital, University of Bern, Switzerland; Biomedical Ethics Unit, Department of Social Studies of Medicine (A.M., E.V., D.M.B., J.K.), and Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital (I.S.), McGill University, Montreal, Canada; Max Delbrueck Center for Molecular Medicine (F.P.), Berlin; Department of Neurology (F.P.), NeuroCure Clinical Research Center and Experimental and Clinical Research Center, Charité-Universitätsmedizin Berlin; Humboldt-Universität zu Berlin (U.D.), Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin; and Department of Experimental Neurology and Center for Stroke Research Berlin and QUEST Center for Transforming Biomedical Research (U.D.), Berlin Institute of Health, Germany.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Kimmelman', 'Affiliation': 'From Pytho LLC (P.A.), Brooklyn, NY; Department of Neurology (A.D.), Inselspital, Bern University Hospital, University of Bern, Switzerland; Biomedical Ethics Unit, Department of Social Studies of Medicine (A.M., E.V., D.M.B., J.K.), and Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital (I.S.), McGill University, Montreal, Canada; Max Delbrueck Center for Molecular Medicine (F.P.), Berlin; Department of Neurology (F.P.), NeuroCure Clinical Research Center and Experimental and Clinical Research Center, Charité-Universitätsmedizin Berlin; Humboldt-Universität zu Berlin (U.D.), Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin; and Department of Experimental Neurology and Center for Stroke Research Berlin and QUEST Center for Transforming Biomedical Research (U.D.), Berlin Institute of Health, Germany. jonathan.kimmelman@mcgill.ca.'}]",Neurology,['10.1212/WNL.0000000000009819']
2403,32546726,Phase II trial of CPX-351 in patients with acute myeloid leukemia at high risk for induction mortality.,"CPX-351 is a liposomal formulation of cytarabine/daunorubicin with a 5:1 fixed molar ratio. We investigated the safety and efficacy of escalating doses of CPX-351 in patients with acute myeloid leukemia (AML) at high risk of induction mortality with standard chemotherapy determined through assessment of leukemia and patient-related risk factors for intensive chemotherapy in an open-label, phase II trial. Patients were randomized to receive 50 or 75 units/m 2  on days 1, 3, and 5. Once safety was established, a 100 units/m 2  arm was opened. Fifty-six patients were enrolled, 16, 24, and 16 in the 50, 75, and 100 units/m 2  arms, respectively. The composite complete remission rate (complete remission + complete remission with incomplete blood count recovery) was lowest with 50 units/m 2  (19%) compared with 75 units/m 2  (38%) and 100 units/m 2  (44%) (P = 0.35). The 50 units/m 2  arm had a median OS of 4.3 months, compared with 8.6 and 6.2 months for the 75 and 100 units/m 2  respectively (P = 0.04). Nonhematologic grade 3/4 treatment-emergent adverse events included febrile neutropenia (34%), pneumonia (23%), and sepsis (16%). CPX-351 at 75 units/m 2  has favorable safety and efficacy for AML patients at high risk of induction mortality with some tolerating the standard dose of 100 units/m 2 .",2020,"The 50 units/m 2  arm had a median OS of 4.3 months, compared with 8.6 and 6.2 months for the 75 and 100 units/m 2  respectively (P = 0.04).","['patients with acute myeloid leukemia at high risk for induction mortality', 'Fifty-six patients were enrolled, 16, 24, and 16 in the 50, 75, and 100\u2009units/m 2  arms, respectively', 'patients with acute myeloid leukemia (AML) at high risk of induction mortality with standard chemotherapy determined through assessment of leukemia and patient-related risk factors for intensive chemotherapy in an open-label, phase II trial']","['cytarabine/daunorubicin', 'CPX-351']","['median OS', 'safety and efficacy', 'Nonhematologic grade 3/4 treatment-emergent adverse events included febrile neutropenia', 'composite complete remission rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C2346682', 'cui_str': 'CPX-351'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",56.0,0.0785846,"The 50 units/m 2  arm had a median OS of 4.3 months, compared with 8.6 and 6.2 months for the 75 and 100 units/m 2  respectively (P = 0.04).","[{'ForeName': 'Ghayas C', 'Initials': 'GC', 'LastName': 'Issa', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Hagop M', 'Initials': 'HM', 'LastName': 'Kantarjian', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Lianchun', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ning', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Yesid', 'Initials': 'Y', 'LastName': 'Alvarado', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Gautam', 'Initials': 'G', 'LastName': 'Borthakur', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Naval', 'Initials': 'N', 'LastName': 'Daver', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Courtney D', 'Initials': 'CD', 'LastName': 'DiNardo', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Jabbour', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Prithviraj', 'Initials': 'P', 'LastName': 'Bose', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Jain', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Tapan M', 'Initials': 'TM', 'LastName': 'Kadia', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Naqvi', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Pemmaraju', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Srdan', 'Initials': 'S', 'LastName': 'Verstovsek', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Micheal', 'Initials': 'M', 'LastName': 'Andreeff', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Kornblau', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Zeev', 'Initials': 'Z', 'LastName': 'Estrov', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Ferrajoli', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Garcia-Manero', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Maro', 'Initials': 'M', 'LastName': 'Ohanian', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Wierda', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Ravandi', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Cortes', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. jorge.cortes@augusta.edu.'}]",Leukemia,['10.1038/s41375-020-0916-8']
2404,32546944,Impact of Preoperative Video Education for Cataract Surgery on Patient Learning Outcomes.,"Purpose


To assess the effect of an educational video on 1) patient knowledge about cataract surgery, 2) patient perception of preoperative assessment visit quality, 3) face-to-face time with the surgeon, and 4) choices regarding premium intraocular lenses (IOLs) or laser-assisted cataract surgery (LACS).
Setting


Eye clinic in an academic medical center.
Design


Prospective survey of patients who randomly viewed or did not view an educational video.
Methods


Patients of three cataract surgeons completed a survey during cataract surgery preoperative visits. One group viewed an educational video about cataract surgery, while the other did not. All patients received their surgeon's typical preoperative counseling.
Results


A total of 101 patients were surveyed. Out of 101 patients, 58 viewed the educational video. Patients who viewed the video exhibited stronger learning outcomes; in particular, patients who viewed the video scored higher on cataract surgery educational assessments than those who did not (83% vs 76%, p=0.032), particularly on the assessment of postoperative visual expectations (98% vs 80%, p=0.003). Differences in educational assessment scores between groups were not affected by which surgeon patients saw (p=0.807). Patients who watched the video were more likely to agree their surgeon provided quality explanations (93% vs 74% strongly agreed, p=0.025) and trended toward greater perception the surgeon spent enough time with them (p=0.067). Video education did not affect face-to-face surgeon time with patients (p=0.212) or choices of multifocal IOLs (p=0.795), toric IOLs (p=0.321), or LACS (p=0.940).
Conclusion


Video education during preoperative cataract surgery assessments improved patient understanding of cataract surgery and perception of preoperative visits. Video education is easily integrated into preoperative visits and can enhance the preoperative experience.",2020,Differences in educational assessment scores between groups were not affected by which surgeon patients saw (p=0.807).,"['Cataract Surgery on Patient Learning Outcomes', 'Setting\n\n\nEye clinic in an academic medical center', '101 patients, 58 viewed the educational video', 'patients who randomly viewed or did not view an educational video', '101 patients were surveyed']","['educational video about cataract surgery', 'educational video on 1) patient knowledge about cataract surgery, 2) patient perception of preoperative assessment visit quality, 3) face-to-face time with the surgeon, and 4) choices regarding premium intraocular lenses (IOLs) or laser-assisted cataract surgery (LACS', 'Preoperative Video Education']","['postoperative visual expectations', 'patient understanding of cataract surgery and perception of preoperative visits', 'educational assessment scores', 'agree their surgeon provided quality explanations', 'learning outcomes', 'cataract surgery educational assessments']","[{'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0085848', 'cui_str': 'Assessment, Educational'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",101.0,0.0197224,Differences in educational assessment scores between groups were not affected by which surgeon patients saw (p=0.807).,"[{'ForeName': 'C Ellis', 'Initials': 'CE', 'LastName': 'Wisely', 'Affiliation': 'Duke University, Department of Ophthalmology, Durham, NC, USA.'}, {'ForeName': 'Cason B', 'Initials': 'CB', 'LastName': 'Robbins', 'Affiliation': 'Duke University, School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Stinnett', 'Affiliation': 'Duke University, Department of Ophthalmology, Durham, NC, USA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Kim', 'Affiliation': 'Duke University, Department of Ophthalmology, Durham, NC, USA.'}, {'ForeName': 'Robin R', 'Initials': 'RR', 'LastName': 'Vann', 'Affiliation': 'Duke University, Department of Ophthalmology, Durham, NC, USA.'}, {'ForeName': 'Preeya K', 'Initials': 'PK', 'LastName': 'Gupta', 'Affiliation': 'Duke University, Department of Ophthalmology, Durham, NC, USA.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S248080']
2405,32546939,A Comparative Assessment of Intraoperative Complication Rates in Resident-Performed Phacoemulsification Surgeries According to Najjar-Awwad Preoperative Risk Stratification.,"Introduction


Phacoemulsification cataract surgery presents a challenge to resident surgeons with lower experience, which confronts with patient safety. In this study, we compared major intraoperative surgical complications of resident-performed phacoemulsification surgeries between cases with low intraoperative risk and random cases with unknown intraoperative risk.
Methods


This prospective randomized controlled study was done on patients who underwent phacoemulsification surgery by third- and fourth-year residents in Khatam-al-Anbia eye hospital, Mashhad, Iran. Preoperative risk was calculated using Najjar-Awwad risk score after slit lamp examination and the patients with scores 7 or higher were considered high-risk. Patients were randomly assigned into a study group, in which only low-risk cases were operated by third-year residents, or control group, in which third-year residents were able to operate any patient regardless of the risk score. In both groups, the remaining patients were operated by fourth-year residents. All intraoperative complications were recorded. Data were analyzed using SPSS, considering P<0.05 significant.
Results


Overall, 475 patients with cataract in the study (N=232) and control (N=243) groups were operated. Mean overall Najjar-Awwad risk scores did not differ significantly between the groups, but pseudoexfoliation and poor pupil dilatation occurred significantly more frequently in the control group (P=0.010 and P=0.014, respectively). Overall, 36 surgeries in the study group (15.5%) and 47 surgeries in the control group (19.3%) were complicated (P=0.273). There was a significant difference between the third- and fourth-year residents regarding the inability to complete continuous curvilinear capsulorhexis (P=0.033). The risk of overall and major complications in high-risk cases was significantly higher among those operated by 3rd-year residents compared with those operated by 4th-year residents (OR=3.45, 95% CI=1.2-9.9, P=0.016 and OR=6.37, 95% CI=1.99-20.34, P=0.001, respectively).
Conclusion


Although supervised resident-performed phacoemulsification has a relatively safe learning curve in our residency program, it is best to stratify preoperative risk and assign high-risk cases to senior residents with higher experience.",2020,There was a significant difference between the third- and fourth-year residents regarding the inability to complete continuous curvilinear capsulorhexis (P=0.033).,"['patients who underwent phacoemulsification surgery by third- and fourth-year residents in Khatam-al-Anbia eye hospital, Mashhad, Iran', '475 patients with cataract in the study (N=232) and control (N=243) groups were operated', 'cases with low intraoperative risk and random cases with unknown intraoperative risk', 'Resident-Performed Phacoemulsification Surgeries']","['resident-performed phacoemulsification surgeries', 'Introduction\n\n\nPhacoemulsification cataract surgery']","['Mean overall Najjar-Awwad risk scores', 'risk of overall and major complications', 'Preoperative risk', 'Intraoperative Complication Rates', 'pseudoexfoliation and poor pupil dilatation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C4517786', 'cui_str': '475'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}]",475.0,0.048145,There was a significant difference between the third- and fourth-year residents regarding the inability to complete continuous curvilinear capsulorhexis (P=0.033).,"[{'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Gharaee', 'Affiliation': 'Eye Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Jahani', 'Affiliation': 'Eye Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Banan', 'Affiliation': 'Eye Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S252418']
2406,32546954,Survey of Postoperative Pain in Photorefractive Keratectomy Using Topical versus Oral Nonsteroidal Anti-Inflammatory Drugs.,"Purpose


To evaluate and compare postoperative pain following photorefractive keratectomy (PRK) in patients using a preventive regimen of oral versus topical nonsteroidal anti-inflammatory drugs (NSAIDs).
Patients and Methods


A prospective, randomized, longitudinal survey of postoperative PRK pain was performed on 157 subjects in a tertiary academic medical center setting. Patients were randomized to either topical ketorolac 0.4% every 12 hours or oral naproxen sodium 220 mg every 12 hours for 72 hours following PRK, beginning at the time of surgery. The primary outcome measure was the daily peak pain score from the validated numerical rating scale (NRS) for five days after surgery.
Results


The peak pain scores were significantly higher in the oral NSAID group (mean 5.82, SD 1.94) compared to the topical NSAID group (mean 4.2, SD 2.19) (p<0.0001) after PRK. When comparing each postoperative day after PRK, the pain scores from 24 to 48 hours (day 2) were significantly higher in the oral NSAID group (mean 5.17, SD 2.25) as compared to the topical NSAID group (mean 3.21, SD 2.09) (p<0.0001). Pain scores 24-72 hours after surgery (days 2 and 3) were higher than pain scores on days 1, 4, and 5 for both groups.
Conclusion


Twice daily oral naproxen sodium 220 mg is inferior to twice daily topical ketorolac 0.4% in the treatment of early postoperative pain after PRK. This study also identified a consistent trend in which pain scores were highest 24-72 hours after the procedure. This additional observation may be useful in understanding, preventing, and treating post-PRK pain.",2020,"The peak pain scores were significantly higher in the oral NSAID group (mean 5.82, SD 1.94) compared to the topical NSAID group (mean 4.2, SD 2.19) (p<0.0001) after PRK.","['patients using a preventive regimen of oral versus topical nonsteroidal anti-inflammatory drugs (NSAIDs', 'early postoperative pain after PRK', '157 subjects in a tertiary academic medical center setting']","['photorefractive keratectomy (PRK', 'naproxen sodium', 'topical ketorolac', 'oral naproxen sodium', 'topical NSAID']","['peak pain scores', 'pain scores', 'Pain scores', 'daily peak pain score from the validated numerical rating scale (NRS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0395416', 'cui_str': 'Refractive keratoplasty by laser surgery'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C0395416', 'cui_str': 'Refractive keratoplasty by laser surgery'}, {'cui': 'C0546873', 'cui_str': 'Naproxen sodium'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",157.0,0.0946927,"The peak pain scores were significantly higher in the oral NSAID group (mean 5.82, SD 1.94) compared to the topical NSAID group (mean 4.2, SD 2.19) (p<0.0001) after PRK.","[{'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Ripa', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, John A. Moran Eye Center, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Betts', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, John A. Moran Eye Center, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Shagun', 'Initials': 'S', 'LastName': 'Dhaliwal', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, John A. Moran Eye Center, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Kaidi', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, John A. Moran Eye Center, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Severin', 'Initials': 'S', 'LastName': 'Pouly', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, John A. Moran Eye Center, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Danli', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Division of Epidemiology, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Mifflin', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, John A. Moran Eye Center, University of Utah, Salt Lake City, UT, USA.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S255441']
2407,32546958,Inhibitory Effect of  Lygodium  Root on the Cytochrome P450 3A Enzyme in vitro and in vivo.,"Purpose


The aim of the present study was to investigate the interactions of the main components of  Lygodium  root (ie, p-coumaric acid, acacetin, apigenin, buddleoside and Diosmetin-7-O-β-D-glucopyranoside) with cytochrome P450 3A enzyme activity both in vitro and in vivo.
Methods


In vitro inhibition of drugs was assessed by incubating rat liver microsomes (RLMs) with a typical P450 3A enzyme substrate, midazolam, to determine their 50% inhibitory concentration (IC50) values. For the in vivo study, healthy male Sprague Dawley rats were consecutively administered acacetin or apigenin for 7 days at the dosage of 5 mg/kg after being randomly divided into 3 groups: Group A (control group), Group B (acacetin group) and Group C (apigenin group).
Results


Among the five main components of  Lygodium  root, only acacetin and apigenin showed inhibitory effects on the cytochrome P450 3A enzyme in vitro. The IC50 values of acacetin and apigenin were 58.46 μM and 8.20 μM, respectively. Additionally, the in vivo analysis results revealed that acacetin and apigenin could systemically inhibit midazolam metabolism in rats. The T max , AUC (0-t)  and C max  of midazolam in group B and group C were significantly increased ( P <0.05), accompanied by a significant decrease in V z/F  and CL z/F  ( P <0.05).
Conclusion


Acacetin and apigenin could inhibit the activity of the cytochrome P450 3A enzyme in vitro and in vivo, indicating that herbal drug interactions might occur when taking  Lygodium  root and midazolam synchronously.",2020,"The T max , AUC (0-t)  and C max  of midazolam in group B and group C were significantly increased ( P <0.05), accompanied by a significant decrease in V z/F  and CL z/F  ( P <0.05).
","['healthy male Sprague Dawley rats', 'rats']","['Group B (acacetin group) and Group C (apigenin group', 'acacetin or apigenin']","['V z/F  and CL z/F', 'IC50 values of acacetin and apigenin', 'T max , AUC (0-t)  and C max  of midazolam']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0034715', 'cui_str': 'Sprague-Dawley rat'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}]","[{'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0100994', 'cui_str': 'acacetin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0912024', 'cui_str': 'Apigenin'}]","[{'cui': 'C0600495', 'cui_str': 'IC50'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0100994', 'cui_str': 'acacetin'}, {'cui': 'C0912024', 'cui_str': 'Apigenin'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]",,0.0235741,"The T max , AUC (0-t)  and C max  of midazolam in group B and group C were significantly increased ( P <0.05), accompanied by a significant decrease in V z/F  and CL z/F  ( P <0.05).
","[{'ForeName': 'Yunfang', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ""The Laboratory of Clinical Pharmacy, The Sixth Affiliated Hospital of Wenzhou Medical University, The People's Hospital of Lishui, Lishui, Zhejiang 323000, People's Republic of China.""}, {'ForeName': 'Ailian', 'Initials': 'A', 'LastName': 'Hua', 'Affiliation': ""Department of Pharmacy, The First People's Hospital of Yuhang District, Hangzhou, Zhejiang 311100, People's Republic of China.""}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': ""The Laboratory of Clinical Pharmacy, The Sixth Affiliated Hospital of Wenzhou Medical University, The People's Hospital of Lishui, Lishui, Zhejiang 323000, People's Republic of China.""}, {'ForeName': 'Peiwu', 'Initials': 'P', 'LastName': 'Geng', 'Affiliation': ""The Laboratory of Clinical Pharmacy, The Sixth Affiliated Hospital of Wenzhou Medical University, The People's Hospital of Lishui, Lishui, Zhejiang 323000, People's Republic of China.""}, {'ForeName': 'Feifei', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': ""The Laboratory of Clinical Pharmacy, The Sixth Affiliated Hospital of Wenzhou Medical University, The People's Hospital of Lishui, Lishui, Zhejiang 323000, People's Republic of China.""}, {'ForeName': 'Lianhe', 'Initials': 'L', 'LastName': 'Yan', 'Affiliation': ""The Laboratory of Clinical Pharmacy, The Sixth Affiliated Hospital of Wenzhou Medical University, The People's Hospital of Lishui, Lishui, Zhejiang 323000, People's Republic of China.""}, {'ForeName': 'Shuanghu', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""The Laboratory of Clinical Pharmacy, The Sixth Affiliated Hospital of Wenzhou Medical University, The People's Hospital of Lishui, Lishui, Zhejiang 323000, People's Republic of China.""}, {'ForeName': 'Congcong', 'Initials': 'C', 'LastName': 'Wen', 'Affiliation': ""Laboratory Animal Centre, Wenzhou Medical University, Wenzhou, Zhejiang 325027, People's Republic of China.""}]","Drug design, development and therapy",['10.2147/DDDT.S249308']
2408,32546962,Comparison of the Pharmacokinetics of Highly Variable Drugs in Healthy Subjects Using a Partial Replicated Crossover Study: A Fixed-Dose Combination of Fimasartan 120 mg and Atorvastatin 40 mg versus Separate Tablets.,"Purpose


A fixed-dose combination (FDC) of fimasartan and atorvastatin is used to treat hypertension and dyslipidemia. The peak plasma concentration (C max ) of fimasartan and atorvastatin has a large intra-subject variability with a maximum coefficient of variation of 65% and 48%, respectively. Therefore, both drugs are classified as highly variable drugs. The purpose of this study was to compare the pharmacokinetics (PK) between a FDC of fimasartan 120 mg and atorvastatin 40 mg versus separate tablets in healthy male Korean subjects.
Subjects and Methods


A randomized, single-dose, two-treatment, three-sequence, three-period, partial replicated crossover study was conducted with a 7-day washout interval between periods. Blood samples for fimasartan and atorvastatin were collected until 48 hours after administration in each period. PK parameters were calculated using the non-compartmental method. Geometric mean ratios (GMRs) for PK parameters of FDC to loose combination and their 90% confidence intervals (90% CIs) were estimated.
Results


A total of 56 subjects completed the study. GMRs (90% CIs) of the C max  for fimasartan and atorvastatin were 1.08 (0.93-1.24) and 1.02 (0.92-1.13), respectively. The expanded 90% CIs of both drugs using the intra-subject variability was calculated range of 0.70-1.43 and 0.73-1.38, respectively. The corresponding values of area under the concentration-time curve from zero to the last measurable time point were 1.02 (0.97-1.08) and 1.02 (0.98-1.07), respectively.
Conclusion


FDC of fimasartan 120 mg and atorvastatin 40 mg between their loose combination showed similar PK characteristics.",2020,"The peak plasma concentration (C max ) of fimasartan and atorvastatin has a large intra-subject variability with a maximum coefficient of variation of 65% and 48%, respectively.","['56 subjects completed the study', 'healthy male Korean subjects', 'Healthy Subjects']","['atorvastatin', 'FDC of fimasartan 120 mg and atorvastatin', 'fixed-dose combination (FDC) of fimasartan and atorvastatin', 'Fimasartan 120 \ufeffmg and Atorvastatin 40 \ufeffmg versus Separate Tablets', 'fimasartan and atorvastatin']","['peak plasma concentration (C max ', 'PK parameters', 'corresponding values of area under the concentration-time curve', 'Geometric mean ratios (GMRs', 'GMRs', 'pharmacokinetics (PK']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C2825622', 'cui_str': 'fimasartan'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",56.0,0.031992,"The peak plasma concentration (C max ) of fimasartan and atorvastatin has a large intra-subject variability with a maximum coefficient of variation of 65% and 48%, respectively.","[{'ForeName': 'Jun Gi', 'Initials': 'JG', 'LastName': 'Hwang', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Kyung-Sang', 'Initials': 'KS', 'LastName': 'Yu', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'SeungHwan', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}]","Drug design, development and therapy",['10.2147/DDDT.S233732']
2409,32546973,A Pharmacokinetic Drug Interaction Between Fimasartan and Linagliptin in Healthy Volunteers.,"Objective


Fimasartan, an angiotensin II type 1 receptor blocker, and linagliptin, a dipeptidyl-peptidase-4 inhibitor, are frequently coadministered to treat patients with hypertension and diabetes, respectively. This study sought to evaluate the pharmacokinetic interactions between fimasartan and linagliptin after co-administration in healthy Korean subjects.
Methods


The overall study was divided into two separate parts, with each part designed as an open-label, multiple-dose, two-period, and single-sequence study. In Part A, to investigate the effect of linagliptin on fimasartan, 25 subjects received 120 mg fimasartan alone once daily for seven days during Period I, and 120 mg fimasartan with 20 mg linagliptin for seven days during Period II. In Part B, to examine the effect of fimasartan on linagliptin, 12 subjects received only linagliptin once daily for seven days during Period I, followed by concomitant administration of fimasartan for seven days during Period II, at the same doses used in Part A. Serial blood samples were collected at scheduled intervals for up to 24 h after the last dose to determine the steady-state pharmacokinetics of both drugs.
Results


Thirty-six subjects completed the study. The geometric mean ratio and 90% confidence intervals for maximum plasma concentration at steady state (C max,ss ) and area under the concentration-time curve at steady state (AUC τ,ss ) of fimasartan with or without linagliptin were 1.2633 (0.9175-1.7396) and 1.1740 (1.0499-1.3126), respectively. The corresponding values for C max,ss  and AUC τ,ss  of linagliptin with or without fimasartan were 0.9804 (0.8480-1.1336) and 0.9950 (0.9322-1.0619), respectively. A total of eight adverse events (AEs) were reported and the incidence of AEs did not increase significantly with co-administration of the drugs.
Conclusion


Our results suggest that there are no clinically significant pharmacokinetic interactions between fimasartan and linagliptin when co-administered. Treatments were well tolerated during the study, with no serious adverse effects.
Clinical Trial Registry


http://clinicaltrials.gov, NCT03250052.",2020,"A total of eight adverse events (AEs) were reported and the incidence of AEs did not increase significantly with co-administration of the drugs.
","['Healthy Volunteers', 'patients with hypertension and diabetes, respectively', 'Results\n\n\nThirty-six subjects completed the study', 'healthy Korean subjects']","['fimasartan with 20 mg linagliptin', 'fimasartan and linagliptin', 'Fimasartan and Linagliptin', 'angiotensin II type 1 receptor blocker, and linagliptin, a dipeptidyl-peptidase-4 inhibitor', 'fimasartan', 'linagliptin']","['incidence of AEs', 'tolerated', 'pharmacokinetic interactions', 'geometric mean ratio and 90% confidence intervals for maximum plasma concentration at steady state (C max,ss ) and area under the concentration-time curve at steady state (AUC τ,ss ) of fimasartan']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}]","[{'cui': 'C2825622', 'cui_str': 'fimasartan'}, {'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C1449680', 'cui_str': 'Angiotensin II Type 1 Receptor Antagonists'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1868980', 'cui_str': 'Pharmacokinetic interaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C2825622', 'cui_str': 'fimasartan'}]",,0.0234011,"A total of eight adverse events (AEs) were reported and the incidence of AEs did not increase significantly with co-administration of the drugs.
","[{'ForeName': 'Woo Youl', 'Initials': 'WY', 'LastName': 'Kang', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, Kyungpook National University, Daegu, Republic of Korea.'}, {'ForeName': 'Hae Won', 'Initials': 'HW', 'LastName': 'Lee', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, Kyungpook National University, Daegu, Republic of Korea.'}, {'ForeName': 'Mi-Ri', 'Initials': 'MR', 'LastName': 'Gwon', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, Kyungpook National University, Daegu, Republic of Korea.'}, {'ForeName': 'Seungil', 'Initials': 'S', 'LastName': 'Cho', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, Kyungpook National University, Daegu, Republic of Korea.'}, {'ForeName': 'Wang-Seob', 'Initials': 'WS', 'LastName': 'Shim', 'Affiliation': 'Kyung Hee Drug Analysis Center, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Kyung-Tae', 'Initials': 'KT', 'LastName': 'Lee', 'Affiliation': 'Kyung Hee Drug Analysis Center, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Dong Heon', 'Initials': 'DH', 'LastName': 'Yang', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu 41944, Republic of Korea.'}, {'ForeName': 'Sook Jin', 'Initials': 'SJ', 'LastName': 'Seong', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, Kyungpook National University, Daegu, Republic of Korea.'}, {'ForeName': 'Young-Ran', 'Initials': 'YR', 'LastName': 'Yoon', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, Kyungpook National University, Daegu, Republic of Korea.'}]","Drug design, development and therapy",['10.2147/DDDT.S248205']
2410,32546975,A Comparison of Dexmedetomidine and Midazolam for the Prevention of Postoperative Nausea and Vomiting Caused by Hemabate in Cesarean Delivery: A Randomized Controlled Trial.,"Objective


To compare the efficacy of dexmedetomidine and midazolam in the prevention of postoperative nausea and vomiting (PONV) caused by hemabate in postpartum hemorrhage during cesarean delivery.
Methods


One hundred and five parturients with American Society of Anesthesiology (ASA) physical status I and II, aged 20-40 years, undergoing elective cesarean delivery under epidural anesthesia were randomly allocated into dexmedetomidine group (group D, n=35), midazolam group (group M, n=35) and control group (group C, n=35). Patients received an intrauterine injection of 250 μg hemabate and continuous intravenous infusion of 5 units oxytocin immediately following the delivery of the infant. At the same time, patients in group D received 1μg/kg intravenous dexmedetomidine, group M received 0.02 mg/kg intravenous midazolam and group C received 20 mL intravenous saline. Parameters such as the PONV, other adverse reactions (chest distress, flush, etc.) caused by hemabate, patient satisfaction, the sedation (OAA/S) scores, and the hemodynamic parameters were recorded in both groups.
Results


The PONV incidence in group D and group M was significantly lower compared with group C (6%, 17%, and 71% for group D, group M, and group C, respectively, P<0.05). The sedation (OAA/S) scores in group D and group M was significantly higher compared with group C (1.62±0.28, 1.75±0.31, and 1.00±0.00 for group D, group M, and group C, respectively, P<0.05). The patient satisfaction in group D and group M was significantly higher compared with group C (94%, 69%, and 46% for group D, group M, and group C, respectively, P<0.05). Furthermore, there were more patients satisfied with group D than group M (94% vs.69%, P<0.05).
Conclusion


Intravenous dexmedetomidine (1 μg/kg) and midazolam (0.02 mg/kg) were equally effective in preventing PONV introduced by hemabate and dexmedetomidine is superior to midazolam in patient satisfaction.",2020,"The sedation (OAA/S) scores in group D and group M was significantly higher compared with group C (1.62±0.28, 1.75±0.31, and 1.00±0.00 for group D, group M, and group C, respectively, P<0.05).","['I and II, aged 20-40 years, undergoing elective cesarean delivery under epidural anesthesia', 'Caused by Hemabate in Cesarean Delivery', 'Methods\n\n\nOne hundred and five parturients with American Society of Anesthesiology (ASA) physical status']","['intrauterine injection', '20 mL intravenous saline', 'Dexmedetomidine and Midazolam', 'dexmedetomidine and midazolam', 'midazolam', 'dexmedetomidine']","['sedation (OAA/S) scores', 'postoperative nausea and vomiting (PONV', 'patient satisfaction', 'Postoperative Nausea and Vomiting', 'PONV incidence', 'PONV, other adverse reactions (chest distress, flush, etc.) caused by hemabate, patient satisfaction, the sedation (OAA/S) scores, and the hemodynamic parameters']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0121295', 'cui_str': 'Hemabate'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0694756', 'cui_str': 'Intrauterine'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0005874', 'cui_str': 'Blushing'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0121295', 'cui_str': 'Hemabate'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0566961,"The sedation (OAA/S) scores in group D and group M was significantly higher compared with group C (1.62±0.28, 1.75±0.31, and 1.00±0.00 for group D, group M, and group C, respectively, P<0.05).","[{'ForeName': 'Bailong', 'Initials': 'B', 'LastName': 'Hu', 'Affiliation': ""Department of Anesthesiology, The Affiliated Hospital of Guizhou Medical University, Guiyang,People's Republic of China.""}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': ""Department of Clinical Research Centre, The Affiliated Hospital of Guizhou Medical University, Guiyang, People's Republic of China.""}, {'ForeName': 'Xiaohua', 'Initials': 'X', 'LastName': 'Zou', 'Affiliation': ""Department of Anesthesiology, The Affiliated Hospital of Guizhou Medical University, Guiyang,People's Republic of China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': ""Department of Anesthesiology, The Affiliated Hospital of Guizhou Medical University, Guiyang,People's Republic of China.""}, {'ForeName': 'Xingyu', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, The Affiliated Hospital of Guizhou Medical University, Guiyang,People's Republic of China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Tan', 'Affiliation': ""Department of Anesthesiology, The Affiliated Hospital of Guizhou Medical University, Guiyang,People's Republic of China.""}]","Drug design, development and therapy",['10.2147/DDDT.S251525']
2411,32546992,"Effect of the Casein-Derived Peptide Met-Lys-Pro on Cognitive Function in Community-Dwelling Adults Without Dementia: A Randomized, Double-Blind, Placebo-Controlled Trial.","Background


Preventative measures have recently been taken to reduce the incidence of Alzheimer's disease worldwide. We previously showed that Met-Lys-Pro (MKP), a casein-derived angiotensin-converting enzyme inhibitory peptide with the potential to cross the blood-brain barrier, attenuated cognitive decline in a mouse model of Alzheimer's disease. However, the effect of MKP on cognitive function improvement in humans remains unknown. This exploratory study sought to investigate whether MKP intake could improve cognitive function in adults without dementia.
Methods


A total of 268 community-dwelling adults without dementia participated in this 24-week randomized controlled trial. Participants were randomly allocated to the MKP (n = 134) or placebo (n = 134) group. The MKP group received four tablets daily, each containing 50 μg MKP, while the placebo group received four dextrin tablets containing no detectable MKP for 24 weeks. Scores on the Japanese version of the cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog) were used as the primary outcome to compare cognitive function between the MKP and placebo groups. The study products were also evaluated for safety.
Results


The intention-to-treat analysis showed that there was no significant difference between the groups in terms of the ADAS-cog total score. Orientation, as measured by the respective ADAS-cog subscale, was significantly improved compared to placebo at 24 weeks post-MKP administration ( P  = 0.022). No serious adverse events due to MKP intake were observed.
Conclusion


To the best of our knowledge, this is the first study to report the effects of MKP on human cognition. These preliminary results suggested the safety of daily MKP intake and its potential to improve orientation in adults without dementia. Further clinical studies are needed to confirm the present findings and the benefits of MKP on cognitive function.",2020,"Orientation, as measured by the respective ADAS-cog subscale, was significantly improved compared to placebo at 24 weeks post-MKP administration ( P  = 0.022).","['adults without dementia', 'Community-Dwelling Adults Without Dementia', '268 community-dwelling adults without dementia participated']","['Placebo', 'dextrin tablets containing no detectable MKP', 'MKP', 'Casein-Derived Peptide Met-Lys-Pro', 'MKP intake', 'placebo']","['respective ADAS-cog subscale', 'cognitive function', ""Japanese version of the cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog"", 'Cognitive Function', 'ADAS-cog total score']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C4517673', 'cui_str': '268'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0011808', 'cui_str': 'Dextrins'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0065415', 'cui_str': 'lysylproline'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0001457', 'cui_str': 'Adenosine deaminase'}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",268.0,0.336293,"Orientation, as measured by the respective ADAS-cog subscale, was significantly improved compared to placebo at 24 weeks post-MKP administration ( P  = 0.022).","[{'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Yuda', 'Affiliation': 'Food Ingredients and Technology Institute, Morinaga Milk Industry Co., Ltd., Zama, Kanagawa, Japan.'}, {'ForeName': 'Miyuki', 'Initials': 'M', 'LastName': 'Tanaka', 'Affiliation': 'Food Ingredients and Technology Institute, Morinaga Milk Industry Co., Ltd., Zama, Kanagawa, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Yamauchi', 'Affiliation': 'Food Ingredients and Technology Institute, Morinaga Milk Industry Co., Ltd., Zama, Kanagawa, Japan.'}, {'ForeName': 'Fumiaki', 'Initials': 'F', 'LastName': 'Abe', 'Affiliation': 'Food Ingredients and Technology Institute, Morinaga Milk Industry Co., Ltd., Zama, Kanagawa, Japan.'}, {'ForeName': 'Izumi', 'Initials': 'I', 'LastName': 'Kakiuchi', 'Affiliation': 'Department of Nursing, Matsumoto Junior College, Matsumoto, Nagano, Japan.'}, {'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Kiyosawa', 'Affiliation': 'Department of Nursing, Matsumoto Junior College, Matsumoto, Nagano, Japan.'}, {'ForeName': 'Mitsunaga', 'Initials': 'M', 'LastName': 'Miyasaka', 'Affiliation': 'Department of Nursing, Matsumoto Junior College, Matsumoto, Nagano, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Sakane', 'Affiliation': 'Division of Preventive Medicine, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Matsumoto City Hospital, Matsumoto, Nagano, Japan.'}]",Clinical interventions in aging,['10.2147/CIA.S253116']
2412,32547030,Evidence for a Beneficial Effect of Oral N-acetylcysteine on Functional Outcomes and Inflammatory Biomarkers in Patients with Acute Ischemic Stroke.,"Purpose


Numerous preclinical studies have demonstrated the potential neuroprotective effects of N-acetylcysteine (NAC) in the treatment of brain ischemia. Accordingly, the present study aimed to assess the potential therapeutic effects of oral NAC in patients with acute ischemic stroke.
Patients and Methods


In a randomized, double-blind, placebo-controlled trial study, 68 patients with acute ischemic stroke with the onset of symptoms less than 24 hours were randomly assigned to either the NAC-treated group or placebo-treated group. NAC and matched placebo were administrated by a 72-hour oral protocol (initially 4 grams loading dose and after on, 4 g in 4 equal divided doses for more 2 days). The primary outcomes were quantification of any neurologic deficit by the use of the National Institute of Health Stroke Scale (NIHSS) score and functional disability by the use of the modified Rankin scale (mRS) at 90 days after stroke. Additionally, serum levels of markers of oxidative stress and inflammation as a main mechanism of its action were assessed at baseline and the end of 3-day treatment protocol.
Results


NAC-treated patients in comparison with placebo-treated patients showed a significantly lower mean NIHSS scores at day 90 after stroke. A favorable functional outcome which was defined as an mRS score of 0 or 1, also in favor of NAC compared to placebo was noted on day 90 after stroke (57.6% in the NAC-treated group compared with 28.6% in the placebo-treated group). Further, compared to the placebo, NAC treatment significantly decreased serum levels of proinflammatory biomarkers such as interleukin 6 (IL-6), soluble intercellular cell adhesion molecule-1 (sICAM-1), nitric oxide (NO), malondialdehyde (MDA), and neuron-specific enolase (NSE) and significantly increased serum levels of anti-oxidant biomarkers such as superoxide dismutase (SOD), glutathione peroxidase (GPx), and total thiol groups (TTG).
Conclusion


The pattern of results suggests that oral NAC administration early after an acute ischemic stroke is associated with a better outcome profile in terms of acute neurological deficit and disability grade compared to placebo. NAC may improve neurological outcomes of patients with stroke at least in part by its antioxidant and anti-inflammatory effects.",2020,"Results


NAC-treated patients in comparison with placebo-treated patients showed a significantly lower mean NIHSS scores at day 90 after stroke.","['patients with acute ischemic stroke', '68 patients with acute ischemic stroke with the onset of symptoms less than 24 hours', 'Patients with Acute Ischemic Stroke']","['placebo, NAC', 'N-acetylcysteine (NAC', 'NAC-treated group or placebo-treated group', 'Oral N-acetylcysteine', 'oral NAC', 'NAC', 'NAC and matched placebo', 'placebo']","['serum levels of proinflammatory biomarkers such as interleukin 6 (IL-6), soluble intercellular cell adhesion molecule-1 (sICAM-1), \ufeffnitric oxide (NO), \ufeffmalondialdehyde (MDA), and neuron-specific enolase (NSE', 'Functional Outcomes and Inflammatory Biomarkers', 'neurological outcomes', 'mRS score', 'serum levels of markers of oxidative stress and inflammation', 'serum levels of anti-oxidant biomarkers such as superoxide dismutase (SOD), glutathione peroxidase (GPx), and total thiol groups (TTG', 'mean NIHSS scores', 'quantification of any neurologic deficit by the use of the National Institute of Health Stroke Scale (NIHSS) score and functional disability by the use of the modified Rankin scale (mRS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439584', 'cui_str': '24 hours'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0242565', 'cui_str': 'Intercellular Adhesion Molecules'}, {'cui': 'C0030015', 'cui_str': 'Oxides'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0202144', 'cui_str': 'Neuron-specific enolase measurement'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038734', 'cui_str': 'Sulfhydryls'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",68.0,0.334566,"Results


NAC-treated patients in comparison with placebo-treated patients showed a significantly lower mean NIHSS scores at day 90 after stroke.","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Sabetghadam', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Medicinal Plants and Natural Products Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Mehrdokht', 'Initials': 'M', 'LastName': 'Mazdeh', 'Affiliation': 'Department of Neurology, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Parnaz', 'Initials': 'P', 'LastName': 'Abolfathi', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Medicinal Plants and Natural Products Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Younes', 'Initials': 'Y', 'LastName': 'Mohammadi', 'Affiliation': 'Modeling of Noncommunicable Diseases Research Center, School of Public Health, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Mehrpooya', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Medicinal Plants and Natural Products Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}]",Neuropsychiatric disease and treatment,['10.2147/NDT.S241497']
2413,32547031,Clinical Validity of Subjective Clinical Prognosis in First Episode Psychosis Schizophrenia Patients: An Analysis of Data from the European First Episode Schizophrenia Trial (EUFEST) Study.,"Purpose


This study examined the validity of subjective clinical prognosis (SCP), a commonly used clinical tool, in first episode psychosis patients included in the European First Episode Schizophrenia Trial (EUFEST) study.
Patients and Methods


The study comprised 455 patients from the EUFEST trial (mean age 25.92, SD=5.45; 188 (41.31%) women, 267 (58.69%) men). SCP was classified into three mutually exclusive groups: ""good prognosis"" (GP) (n=265), ""average prognosis"" (AP) (n=131), and ""poor prognosis"" (PP) (n=59). The validity of the SCP was assessed by investigating the differences between the SCP groups and completer or responder status of the patients, during 1 year of the trial.
Results


The proportion of completers was significantly higher in the GP group (64.4%) compared to the AP group (25.6%) (OR=1.62, 95% CI=1.062-2.476,  p <0.031) and the PP group (10%) (OR=2.17, 95% CI=1.226-3.853,  p <0.009) throughout the whole duration of the trial. In what concerns responsiveness, a significantly higher number of responders were registered in the GP group compared to the AP and the PP groups in the first three months of treatment, but this outcome did not persist afterwards.
Conclusion


In terms of its predictive value at first episode schizophrenic patients, SCP seems to be reliable for treatment completion, but has a limited utility in what concerns responsiveness to treatment. This finding suggests the necessity of creating a prediction model potentially including, besides SCP, other measurement-based variables.",2020,"The proportion of completers was significantly higher in the GP group (64.4%) compared to the AP group (25.6%) (OR=1.62, 95% CI=1.062-2.476,  p <0.031) and the PP group (10%) (OR=2.17, 95% CI=1.226-3.853,  p <0.009) throughout the whole duration of the trial.","['SCP was classified into three mutually exclusive groups: ""good prognosis"" (GP) (n=265), ""average prognosis"" (AP) (n=131), and ""poor prognosis"" (PP) (n=59', 'first episode psychosis patients included in the European First Episode Schizophrenia Trial (EUFEST) study', '455 patients from the EUFEST trial (mean age 25.92, SD=5.45; 188 (41.31%) women, 267 (58.69%) men', 'First Episode Psychosis Schizophrenia Patients\ufeff']",['\ufeffsubjective \ufeffclinical \ufeffprognosis (SCP'],[],"[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0278250', 'cui_str': 'Prognosis good'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0278252', 'cui_str': 'Prognosis bad'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}]",[],455.0,0.0335307,"The proportion of completers was significantly higher in the GP group (64.4%) compared to the AP group (25.6%) (OR=1.62, 95% CI=1.062-2.476,  p <0.031) and the PP group (10%) (OR=2.17, 95% CI=1.226-3.853,  p <0.009) throughout the whole duration of the trial.","[{'ForeName': 'Valentin Petre', 'Initials': 'VP', 'LastName': 'Matei', 'Affiliation': 'Clinical Hospital of Psychiatry ""Alexandru Obregia"", Bucharest, Romania.'}, {'ForeName': 'Alexandra Ioana', 'Initials': 'AI', 'LastName': 'Mihăilescu', 'Affiliation': 'Clinical Hospital of Psychiatry ""Alexandru Obregia"", Bucharest, Romania.'}, {'ForeName': 'Iuliana Raluca', 'Initials': 'IR', 'LastName': 'Gheorghe', 'Affiliation': 'Department of Marketing and Medical Technology, Faculty of Medicine, ""Carol Davila"" University of Medicine and Pharmacy, Bucharest, Romania.'}, {'ForeName': 'Ruxandra', 'Initials': 'R', 'LastName': 'Grigoraş', 'Affiliation': 'Voila Psychiatric Hospital, Câmpina, Romania.'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Crasan', 'Affiliation': 'The City Hospital of Curtea De Argeş, Curtea De Argeș, Romania.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Roșca', 'Affiliation': 'Clinical Hospital of Psychiatry ""Alexandru Obregia"", Bucharest, Romania.'}, {'ForeName': 'Ovidiu', 'Initials': 'O', 'LastName': 'Popa-Velea', 'Affiliation': 'Department of Medical Psychology, Faculty of Medicine, ""Carol Davila"" University of Medicine and Pharmacy, Bucharest, Romania.'}]",Neuropsychiatric disease and treatment,['10.2147/NDT.S246492']
2414,32547172,Comparison of Analgesic Effect Between Erector Spinae Plane Block and Transversus Abdominis Plane Block After Elective Cesarean Section: A Prospective Randomized Single-Blind Controlled Study.,"Background


This study compared the analgesic efficacy of a bilateral erector spinae plane (ESP) block with that of a bilateral transversus abdominis plane (TAP) block after elective cesarean delivery.
Methods


Sixty mothers scheduled for elective cesarean delivery under spinal anesthesia were randomly allocated to receive either ESP block or TAP block. The ESP group received ESP block at the level of the ninth thoracic transverse process with 20 mL of 0.25% bupivacaine at the end of surgery. The TAP group received an ultrasound-guided TAP block with 20 mL of 0.25% bupivacaine on completion of delivery. The primary outcome was the duration of analgesia achieved by each block. Secondary outcome measures were the postoperative pain severity, total tramadol consumption, patient satisfaction.
Results


The median (interquartile range) duration of block was longer in the ESP group than in the TAP group (12 hours [10, 14] vs 8 hours [8, 8], p<0.0001). In the first 24 hours, the mean visual analog pain score at rest was lower by 0.32 units in the ESP group. The median tramadol consumption in the first 24 hours was significantly higher in the TAP group than in the ESP group (125 mg [100, 150] vs 100 mg [75, 100, p=0.003]).
Conclusion


Compared with the TAP block, the ESP block provides more effective pain relief, has a longer duration of analgesic action, prolongs time to first analgesic requirement, is associated with less tramadol consumption, and can be used in multimodal analgesia and opioid-sparing regimens after cesarean section.",2020,"The median tramadol consumption in the first 24 hours was significantly higher in the TAP group than in the ESP group (125 mg [100, 150] vs 100 mg [75, 100, p=0.003]).
","['Methods\n\n\nSixty mothers scheduled for elective cesarean delivery under spinal anesthesia', 'After Elective Cesarean Section']","['ESP block or TAP block', 'ESP', 'bupivacaine', 'ultrasound-guided TAP block with 20 mL of 0.25% bupivacaine', 'TAP', 'ESP block', 'bilateral erector spinae plane (ESP) block with that of a bilateral transversus abdominis plane (TAP) block', 'Erector Spinae Plane Block and Transversus Abdominis Plane Block']","['mean visual analog pain score', 'median tramadol consumption', 'analgesic efficacy', 'postoperative pain severity, total tramadol consumption, patient satisfaction', 'Analgesic Effect', 'median (interquartile range) duration of block', 'effective pain relief', 'duration of analgesia achieved by each block']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",60.0,0.0821537,"The median tramadol consumption in the first 24 hours was significantly higher in the TAP group than in the ESP group (125 mg [100, 150] vs 100 mg [75, 100, p=0.003]).
","[{'ForeName': 'Maged Labib', 'Initials': 'ML', 'LastName': 'Boules', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Fayoum University, Cairo, Egypt.'}, {'ForeName': 'Abeer Shaban', 'Initials': 'AS', 'LastName': 'Goda', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Fayoum University, Cairo, Egypt.'}, {'ForeName': 'Mahdy Ahmed', 'Initials': 'MA', 'LastName': 'Abdelhady', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Fayoum University, Cairo, Egypt.'}, {'ForeName': 'Shimaa Adel', 'Initials': 'SA', 'LastName': 'Abu El-Nour Abd El-Azeem', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Fayoum University, Cairo, Egypt.'}, {'ForeName': 'Mohamed Ahmed', 'Initials': 'MA', 'LastName': 'Hamed', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Fayoum University, Cairo, Egypt.'}]",Journal of pain research,['10.2147/JPR.S253343']
2415,32547182,"Perioperative Analgesic Effects of Preemptive Ultrasound-Guided Rectus Sheath Block Combined with Butorphanol or Sufentanil for Single-Incision Laparoscopic Cholecystectomy: A Prospective, Randomized, Clinical Trial.","Purpose


Pain after single-incision laparoscopic cholecystectomy (SILC), especially visceral pain, often troubles patients and doctors. Whether preemptive butorphanol can relieve visceral pain in patients undergoing SILC remains unknown. The goal of this study was to assess the efficacy of ultrasound-guided bilateral rectus sheath block (RSB) and butorphanol for perioperative analgesia in patients undergoing SILC.
Patients and Methods


Fifty-eight patients who met the criteria were randomly divided into two groups, both of which were given preemptive RSB. Patients were given either butorphanol 0.02mg/kg (group B, n=29) or sufentanil 0.1 µg/kg (group S, n=29) as preemptive analgesia. The primary outcome was the cumulative frequency of rescue analgesic request within 24 hours after operation. Secondary outcomes were numeric rating scale (NRS) scores (from 0 to 10) of incisional pain and visceral pain, the length of hospital stay and the incidence of postoperative adverse events.
Results


The frequency of postoperative rescue analgesic request of group S was significantly higher than that of group B (P=0.021). The NRS scores for visceral pain were lower in group B at 2, 6 and 12 hours after surgery than in group S (both P<0.001). The occurrence of postoperative nausea and vomiting (PONV) was significantly higher in group S. There were no significant differences between two groups for other outcomes.
Conclusion


Butorphanol can provide sufficient visceral pain treatment after SILC than the dose of sufentanil in equal analgesic effect.",2020,"The occurrence of postoperative nausea and vomiting (PONV) was significantly higher in group S. There were no significant differences between two groups for other outcomes.
","['patients undergoing SILC remains unknown', 'Patients and Methods\n\n\nFifty-eight patients who met the criteria', 'Single-Incision Laparoscopic Cholecystectomy', 'patients undergoing SILC']","['butorphanol', 'Butorphanol', 'sufentanil', 'preemptive analgesia', 'Preemptive Ultrasound-Guided Rectus Sheath Block Combined with Butorphanol or Sufentanil', 'single-incision laparoscopic cholecystectomy (SILC', 'preemptive RSB', 'ultrasound-guided bilateral rectus sheath block (RSB) and butorphanol']","['occurrence of postoperative nausea and vomiting (PONV', 'numeric rating scale (NRS) scores', 'NRS scores for visceral pain', 'visceral pain', 'cumulative frequency of rescue analgesic request', 'incisional pain and visceral pain, the length of hospital stay and the incidence of postoperative adverse events', 'frequency of postoperative rescue analgesic request']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0006491', 'cui_str': 'Butorphanol'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0234245', 'cui_str': 'Visceral pain'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",58.0,0.0902559,"The occurrence of postoperative nausea and vomiting (PONV) was significantly higher in group S. There were no significant differences between two groups for other outcomes.
","[{'ForeName': 'Huimin', 'Initials': 'H', 'LastName': 'Fu', 'Affiliation': ""Nantong University, Nantong, Jiangsu, People's Republic of China.""}, {'ForeName': 'Chaochao', 'Initials': 'C', 'LastName': 'Zhong', 'Affiliation': ""Department of Anesthesiology, Affiliated Hospital of Nantong University, Nantong, Jiangsu, People's Republic of China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Fu', 'Affiliation': ""Nantong University, Nantong, Jiangsu, People's Republic of China.""}, {'ForeName': 'Yongtao', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': ""Department of Anesthesiology, Affiliated Hospital of Nantong University, Nantong, Jiangsu, People's Republic of China.""}, {'ForeName': 'Xingguo', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""Department of Anesthesiology, Affiliated Hospital of Nantong University, Nantong, Jiangsu, People's Republic of China.""}]",Journal of pain research,['10.2147/JPR.S252952']
2416,32547185,Acute Cytokine Response During Breast Cancer Surgery: Potential Role of Dexamethasone and Lidocaine and Relationship with Postoperative Pain and Complications - Analysis of Three Pooled Pilot Randomized Controlled Trials.,"Purpose


An imbalance in perioperative cytokine response may cause acute pain and postoperative complications. Anesthetic drugs modulate this cytokine response, but their role in non-major breast cancer surgery is unclear. In an exploratory study, we investigated whether intravenous lidocaine and dexamethasone could modulate the cytokine response into an anti-inflammatory direction. We also evaluated interrelationships between cytokine levels, pain scores and postoperative complications. Our goal is to develop multimodal analgesia regimens optimizing outcome after breast cancer surgery.
Patients and Methods


Forty-eight patients undergoing a lumpectomy were randomly assigned to placebo or lidocaine (1.5 mg⋅kg -1  followed by 2 mg⋅kg -1 ⋅hour -1 ) supplemented by dexamethasone zero, 4 or 8 mg, yielding six groups of eight patients. Interleukin (IL)-1β, IL-1Ra, IL-6, IL-10 levels and pain scores were measured at baseline and four hours postoperatively. We assessed postoperative complications occurring within 30 days. We noted persistent pain and infections as potential immune-related complications (PIRC). We used multiple regression to disentangle the effects of the individual study drugs (given by their partial regression coefficients (b)). Odds ratios (OR) estimated the link between pain scores and complications.
Results


Dexamethasone 8 mg increased IL-10 (b=12.70 (95% CI=8.06-17.34),  P <0.001). Dexamethasone 4 mg and 8 mg decreased the ratio IL-6/IL-10 (b=-2.60 (-3.93 to -1.26),  P <0.001 and b=-3.59 (-5.04 to -2.13),  P <0.001, respectively). We could not show modulatory effects of lidocaine on cytokines. High pain scores were linked to the occurrence of PIRC's (OR=2.028 (1.134-3.628),  P =0.017). Cytokine levels were not related either to acute pain or PIRC.
Conclusion


Dexamethasone modulated the perioperative cytokine response into an anti-inflammatory direction. An overall lidocaine effect was not found. Patients with higher pain scores suffered from more 30-day PIRCs. Cytokine levels were not associated with pain or more postoperative complications, even not with PIRC. Larger studies in breast cancer surgery are needed to confirm these explorative results.",2020,"Dexamethasone 4 mg and 8 mg decreased the ratio IL-6/IL-10 (b=-2.60 (-3.93 to -1.26),  P <0.001 and b=-3.59 (-5.04 to -2.13),  P <0.001, respectively).","['Patients and Methods\n\n\nForty-eight patients undergoing a lumpectomy', 'breast cancer surgery', 'Breast Cancer Surgery']","['lidocaine and dexamethasone', 'Dexamethasone and Lidocaine', 'dexamethasone', 'lidocaine', 'Dexamethasone', 'placebo or lidocaine']","[' IL-6, IL-10 levels and pain scores', 'cytokine response', 'Odds ratios (OR', 'Cytokine levels', 'Interleukin (IL)-1β, IL-1Ra', 'High pain scores', ""occurrence of PIRC's"", 'pain scores and complications', 'Acute Cytokine Response', 'overall lidocaine effect', 'cytokine levels, pain scores and postoperative complications', 'postoperative complications', 'perioperative cytokine response', 'IL-10', 'ratio IL-6/IL-10']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0851238', 'cui_str': 'Lumpectomy of breast'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",48.0,0.400559,"Dexamethasone 4 mg and 8 mg decreased the ratio IL-6/IL-10 (b=-2.60 (-3.93 to -1.26),  P <0.001 and b=-3.59 (-5.04 to -2.13),  P <0.001, respectively).","[{'ForeName': 'Sandra A S', 'Initials': 'SAS', 'LastName': 'van den Heuvel', 'Affiliation': 'Department of Anesthesiology, Pain and Palliative Medicine, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Selina E I', 'Initials': 'SEI', 'LastName': 'van der Wal', 'Affiliation': 'Department of Anesthesiology, Pain and Palliative Medicine, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Ewald M', 'Initials': 'EM', 'LastName': 'Bronkhorst', 'Affiliation': 'Department of Health Evidence, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Michiel C', 'Initials': 'MC', 'LastName': 'Warlé', 'Affiliation': 'Division of Vascular and Transplant Surgery, Department of Surgery, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'May', 'Initials': 'M', 'LastName': 'Ronday', 'Affiliation': 'Department of Anesthesiology, Alexander Monro Breast Cancer Hospital, Bilthoven, the Netherlands.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Plat', 'Affiliation': 'Department of Anesthesiology, Alexander Monro Breast Cancer Hospital, Bilthoven, the Netherlands.'}, {'ForeName': 'Nens', 'Initials': 'N', 'LastName': 'van Alfen', 'Affiliation': 'Donders Institute for Brain Cognition and Behavior, Department of Neurology, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Leo A B', 'Initials': 'LAB', 'LastName': 'Joosten', 'Affiliation': 'Department of Internal Medicine and Radboud Centre for Infectious Diseases, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Jos G C', 'Initials': 'JGC', 'LastName': 'Lerou', 'Affiliation': 'Department of Anesthesiology, Pain and Palliative Medicine, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Kris C P', 'Initials': 'KCP', 'LastName': 'Vissers', 'Affiliation': 'Department of Anesthesiology, Pain and Palliative Medicine, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Monique A H', 'Initials': 'MAH', 'LastName': 'Steegers', 'Affiliation': 'Department of Anesthesiology, Pain and Palliative Medicine, Amsterdam University Medical Centre, Amsterdam, the Netherlands.'}]",Journal of pain research,['10.2147/JPR.S252377']
2417,32547208,"Ramucirumab, A Second-Line Option For Patients With Hepatocellular Carcinoma: A Review Of The Evidence.","Hepatocellular carcinoma (HCC) is the most frequent primary liver cancer and predominantly develops in patients with liver cirrhosis. In patients with advanced disease, such as extra-hepatic extension or portal vein involvement, and with intermediate disease unsuitable for locoregional therapies, systemic therapy is recommended, if liver function and performance status are adequate. Following a decade of negative Phase III trials since the approval of sorafenib, more recently several drugs have proven efficacy both in first line versus sorafenib (lenvatinib) or in second line versus placebo (regorafenib, cabozantinib, ramucirumab). In this review, we summarize the preclinical and clinical evidence supporting the use of ramucirumab, a recombinant IgG1 monoclonal antibody that specifically binds to Vascular Endothelial Growth Factor receptor 2 (VEGFR-2), in HCC. Following the results of the REACH trial, that was negative in the overall study population but identified a subgroup that could benefit from ramucirumab treatment, the REACH-2 trial was a randomized, placebo-controlled trial, designed to assess ramucirumab as second line in patients with alpha-fetoprotein (AFP) ≥400 ng/mL. The results of REACH-2 were published in February 2019, leading to Food and Drug Administration and European Medicines Agency approval of the drug as second-line agent for advanced HCC (after sorafenib) in patients with AFP ≥400 ng/mL. For the first time in the history of systemic treatments for HCC, a predictive factor of efficacy was identified. In this review, we also discuss the potential clinical development of systemic treatments in HCC, focusing on combination therapies with immunotherapy (following the recent results of the combination of atezolizumab and bevacizumab in the IMbrave 150 clinical trial) and treatment sequences as a way to maximize survival benefit.",2020,"The results of REACH-2 were published in February 2019, leading to Food and Drug Administration and European Medicines Agency approval of the drug as second-line agent for advanced HCC (after sorafenib) in patients with AFP ≥400 ng/mL.","['patients with alpha-fetoprotein (AFP) ≥400', 'Hepatocellular carcinoma (HCC', 'patients with advanced disease, such as extra-hepatic extension or portal vein involvement, and with intermediate disease unsuitable for locoregional therapies, systemic therapy', 'patients with AFP ≥400 ng/mL', 'Patients With Hepatocellular Carcinoma', 'patients with liver cirrhosis']","['sorafenib', 'atezolizumab and bevacizumab', 'Ramucirumab, A Second-Line Option', 'sorafenib (lenvatinib) or in second line versus placebo (regorafenib, cabozantinib, ramucirumab', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002210', 'cui_str': 'Alpha fetoprotein'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0032718', 'cui_str': 'Portal vein structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C3181682', 'cui_str': 'cabozantinib'}]",[],,0.165707,"The results of REACH-2 were published in February 2019, leading to Food and Drug Administration and European Medicines Agency approval of the drug as second-line agent for advanced HCC (after sorafenib) in patients with AFP ≥400 ng/mL.","[{'ForeName': 'Emmanuele', 'Initials': 'E', 'LastName': 'De Luca', 'Affiliation': 'Department of Oncology, University of Turin, Torino, Italy.'}, {'ForeName': 'Donatella', 'Initials': 'D', 'LastName': 'Marino', 'Affiliation': 'Department of Oncology, University of Turin, Torino, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Di Maio', 'Affiliation': 'Department of Oncology, University of Turin, Torino, Italy.'}]",Cancer management and research,['10.2147/CMAR.S216220']
2418,32547280,Effects of Total and Partial Sleep Deprivation on Reflection Impulsivity and Risk-Taking in Deliberative Decision-Making.,"Study Objectives


To evaluate the effects of total and partial sleep deprivation on reflection impulsivity and risk-taking in tasks requiring deliberative decision-making processes.
Participants and Methods


Seventy-four healthy young adults were selected to participate in two independent experiments, each consisting of a crossover design. In Experiment 1, 32 participants were tested after one night of regular sleep (RS), and after one night of total sleep deprivation (TSD). In Experiment 2, 42 participants were tested following five nights of RS and after five nights of partial sleep deprivation (PSD), implying five hours of sleep per night. In both the experiments, two deliberative decision-making tasks were administered, involving different decision-making constructs. The Mosaic Task (MT) assessed reflection impulsivity, the tendency to gather information before making a decision. The Columbia Card Task cold version (CCTc) evaluated risk-taking propensity in a dynamic environment.
Results


Unlike TSD, PSD led to an increment of reflection impulsivity and risk-taking. Nevertheless, analyses taking into account the individuals' baseline (RS) performance showed consistent results between the two experimental sleep manipulations. Participants who gathered more information to make decisions in the MT when well-rested, then relied on less evidence under sleep loss, and more cautious participants in the CCTc tended to make riskier decisions.
Conclusion


Results pointed to differential consequences of sleep deprivation depending on the habitual way to respond during decision-making involving deliberative reasoning processes. Results were interpreted according to a putative interaction between sleep loss effect and individual difference factors.",2020,"Nevertheless, analyses taking into account the individuals' baseline (RS) performance showed consistent results between the two experimental sleep manipulations.","['32 participants were tested after one night of regular sleep (RS), and after one night of total sleep deprivation (TSD', '42 participants', 'Participants and Methods\n\n\nSeventy-four healthy young adults']","['partial sleep deprivation (PSD', 'Total and Partial Sleep Deprivation', 'total and partial sleep deprivation']","['Mosaic Task (MT) assessed reflection impulsivity', 'Columbia Card Task cold version (CCTc) evaluated risk-taking propensity', 'reflection impulsivity and risk-taking']","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0439750', 'cui_str': 'Mosaic'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0035651', 'cui_str': 'Risk-Taking'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",74.0,0.0142457,"Nevertheless, analyses taking into account the individuals' baseline (RS) performance showed consistent results between the two experimental sleep manipulations.","[{'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Salfi', 'Affiliation': ""Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Lauriola', 'Affiliation': 'Department of Social and Developmental Psychology, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Tempesta', 'Affiliation': ""Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.""}, {'ForeName': 'Pierpaolo', 'Initials': 'P', 'LastName': 'Calanna', 'Affiliation': 'Department of Dynamic and Clinical Psychology, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Socci', 'Affiliation': ""Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.""}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'De Gennaro', 'Affiliation': 'Department of Psychology, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Ferrara', 'Affiliation': ""Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.""}]",Nature and science of sleep,['10.2147/NSS.S250586']
2419,32547310,N-acetylcysteine Restored Heart Rate Variability and Prevented Serious Adverse Events in Transfusion-dependent Thalassemia Patients: a Double-blind Single Center Randomized Controlled Trial.,"Regular blood transfusions in transfusion-dependent thalassemia (TDT) patients can lead to iron overload, causing oxidative stress and sympathovagal imbalance, resulting in increased cardiac complications. We hypothesized that administrating of N-acetylcysteine (NAC) prevents serious adverse events including cardiac complications in TDT patients by reducing systemic oxidative stress and balancing cardiac sympathovagal control. This study was double-blind, randomized control trial, investigating in 59 Thai TDT patients. After randomization, the participants were divided into two groups. The control group received standard care of TDT patient plus placebo, whereas the intervention group received 600 mg of NAC orally for six months. Serum 8-isoprostane, TNF-alpha, IL-10, 24-hour ECG monitoring, echocardiograms and the incidence of thalassemia-related complications were collected. At baseline, no significant difference in any parameters between the control and the intervention groups. At the end of intervention, the incidence of serious adverse events (i.e. infection, worsening thalassemia) was significantly higher in the control group when compared with the intervention group (24.1% vs. 3.3%, p=0.019) (Chi-square test; absolute risk reduction=20.8%, number needed to treat=4.8). The control group also had significantly lower time-dependent HRV parameters, compared with the intervention group (p=0.025 and 0.030, independent t-test). Treatment with NAC restored HRV and reduced serious adverse event in TDT patients, however, no difference in cardiac complications could be demonstrated. NAC could prevent serious adverse events in TDT patients. The proposed mechanism might be the balancing of sympathovagal control.",2020,"The control group also had significantly lower time-dependent HRV parameters, compared with the intervention group (p=0.025 and 0.030, independent t-test).","['TDT patients', 'Transfusion-dependent Thalassemia Patients', '59 Thai TDT patients']","['NAC', 'N-acetylcysteine (NAC', 'standard care of TDT patient plus placebo']","['cardiac complications', 'Heart Rate Variability', 'serious adverse events', 'Serum 8-isoprostane, TNF-alpha, IL-10, 24-hour ECG monitoring, echocardiograms and the incidence of thalassemia-related complications', 'incidence of serious adverse events (i.e. infection, worsening thalassemia', 'lower time-dependent HRV parameters']","[{'cui': 'C4760934', 'cui_str': 'Transfusion dependent thalassaemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4760934', 'cui_str': 'Transfusion dependent thalassaemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0161816', 'cui_str': 'Cardiac complication'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0295541', 'cui_str': '8-isoprostaglandin F2alpha'}, {'cui': 'C1448177', 'cui_str': 'TNF protein, human'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0430461', 'cui_str': '24 Hour ECG'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039730', 'cui_str': 'Thalassemia'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.207315,"The control group also had significantly lower time-dependent HRV parameters, compared with the intervention group (p=0.025 and 0.030, independent t-test).","[{'ForeName': 'Sintip', 'Initials': 'S', 'LastName': 'Pattanakuhar', 'Affiliation': 'Cardiac Electrophysiology Research and Training Center, Faculty of Medicine, Chiang Mai University, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Arintaya', 'Initials': 'A', 'LastName': 'Phrommintikul', 'Affiliation': 'Cardiac Electrophysiology Research and Training Center, Faculty of Medicine, Chiang Mai University, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Adisak', 'Initials': 'A', 'LastName': 'Tantiworawit', 'Affiliation': 'Cardiac Electrophysiology Research and Training Center, Faculty of Medicine, Chiang Mai University, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Somdet', 'Initials': 'S', 'LastName': 'Srichairattanakool', 'Affiliation': 'Cardiac Electrophysiology Research and Training Center, Faculty of Medicine, Chiang Mai University, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Siriporn C', 'Initials': 'SC', 'LastName': 'Chattipakorn', 'Affiliation': 'Cardiac Electrophysiology Research and Training Center, Faculty of Medicine, Chiang Mai University, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Nipon', 'Initials': 'N', 'LastName': 'Chattipakorn', 'Affiliation': 'Cardiac Electrophysiology Research and Training Center, Faculty of Medicine, Chiang Mai University, Chiang Mai, 50200, Thailand.'}]",International journal of medical sciences,['10.7150/ijms.45795']
2420,32547414,"Carry-Over Quality of Pre-acclimatization to Altitude Elicited by Intermittent Hypoxia: A Participant-Blinded, Randomized Controlled Trial on Antedated Acclimatization to Altitude.","Intermittent normobaric hypoxia (IH) is increasingly used to pre-acclimatize for a sojourn to high altitude. There is a number of hypoxia - protocols observing the hypoxic ventilatory response (HVR), but little is known about the carry - over quality of the Lake Louise Score (LLS). We thus studied a week - long, 1 h per day poikilocapnic hypoxia protocol on whether acclimatization could be carried over for one week. Rationale for this was that it usually takes one week to get from Europe, Britain or the United States to the base camp of a major mountain. Forty-nine healthy volunteers of both sexes were exposed to daily bouts of 1 h at an inspiratory fraction of oxygen (FiO 2 ) of 0.11 or 0.21 (control) for 7 consecutive days. Seven days after cessation of IH or sham exposures participants were again subjected to hypoxia (FiO 2  = 0.11) for 6 h and measurements of isocapnic HVR and blood gases out of the arterialized earlobe were taken and LLS was assessed. In those with IH exposures LLS was reduced which was not the case in those with sham exposure (87 vs. 50%). Changes in HVR or the arterial hemoglobin saturation were not observed. Gender neither affected LLS nor HVR nor blood gases or carry -over quality. We found that our week - long, hypoxia protocol grants a reduction in LLS that can be carried over the time span of one week. In this way, antedated acclimatization may improve safety and comfort on the mountain.",2020,Changes in HVR or the arterial hemoglobin saturation were not observed.,['Forty-nine healthy volunteers of both sexes'],"['Intermittent normobaric hypoxia (IH', 'Pre-acclimatization to Altitude Elicited by Intermittent Hypoxia']","['LLS nor HVR nor blood gases or carry -over quality', 'Changes in HVR or the arterial hemoglobin saturation']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0002349', 'cui_str': 'Altitude'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}]","[{'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}]",49.0,0.0323453,Changes in HVR or the arterial hemoglobin saturation were not observed.,"[{'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Treml', 'Affiliation': 'Department of General and Surgical Intensive Care Medicine, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Kleinsasser', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Hell', 'Affiliation': 'Department of Mathematics, Leopold - Franzens University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Knotzer', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Klinikum Wels - Grieskirchen, Wels, Austria.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Wille', 'Affiliation': 'Department of Sport Science, Medical Section, University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Burtscher', 'Affiliation': 'Department of Sport Science, Medical Section, University Innsbruck, Innsbruck, Austria.'}]",Frontiers in physiology,['10.3389/fphys.2020.00531']
2421,32547425,Energetic Cost and Kinematics of Pushing a Stroller on Flat and Uphill Terrain.,"During early parenthood, walking and/or running while pushing a stroller is a common form of endurance exercise among both recreationally active individuals and athletes. Here, we investigate how pushing a stroller influences the energetic cost, gross efficiency (GE), and kinematic behavior of well-trained men and women while walking or running on flat and uphill incline. Eight men and nine women, all recreationally active, performed three 5-min submaximal tests of walking or running during four different testing sessions, in randomized order: with and without pushing a 24.3-kg stroller on a flat (1%; 6, 8/9, and 11/12 km/h for women/men) and uphill (10%; 5, 6.5/7.5, and 7.5/8.5 km/h for women/men) incline. Respiratory parameters, heart rate (HR), blood lactate concentration, and rating of perceived exertion (RPE) were determined and video-based kinematic analysis was performed in connection with all these tests. Except while walking on the flat incline, pushing a stroller increased the energetic cost of walking/running under all conditions (all  p  < 0.05). This was associated with shorter and more rapid strides on both inclines (all  p  < 0.05); however, GE was higher when pushing the stroller ( p  < 0.05). The increase in energetic cost of pushing the stroller was approximately threefold higher uphill than on the flat incline, and women were influenced more than men when running uphill at the highest speed (all  p  < 0.05). Here, we provide novel insights on the energetic cost and kinematic behavior of pushing a stroller while walking or running on flat and uphill inclines. The energetic cost of pushing a stroller was clearly higher than for unloaded exercise, coincided by shorter and more rapid strides, and especially pronounced on uphill terrain where also women were more influenced than men.",2020,"This was associated with shorter and more rapid strides on both inclines (all  p  < 0.05); however, GE was higher when pushing the stroller ( p  < 0.05).","['trained men and women while walking or running on flat and uphill incline', 'Eight men and nine women, all recreationally active']",[],"['energetic cost of walking/running under all conditions', 'energetic cost of pushing a stroller', 'energetic cost, gross efficiency (GE), and kinematic behavior', 'uphill terrain', 'Energetic Cost and Kinematics of Pushing a Stroller on Flat and Uphill Terrain', 'energetic cost of pushing the stroller', 'Respiratory parameters, heart rate (HR), blood lactate concentration, and rating of perceived exertion (RPE']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0560350', 'cui_str': 'Does run on flat'}, {'cui': 'C0205177', 'cui_str': 'Active'}]",[],"[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0438916', 'cui_str': 'Attendant powered wheelchair'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]",,0.0239862,"This was associated with shorter and more rapid strides on both inclines (all  p  < 0.05); however, GE was higher when pushing the stroller ( p  < 0.05).","[{'ForeName': 'Øyvind', 'Initials': 'Ø', 'LastName': 'Sandbakk', 'Affiliation': 'Centre for Elite Sports Research, Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Rilana', 'Initials': 'R', 'LastName': 'Perl', 'Affiliation': 'Section for Elite Sport, Swiss Federal Institute of Sport, Magglingen, Switzerland.'}, {'ForeName': 'Hans-Christer', 'Initials': 'HC', 'LastName': 'Holmberg', 'Affiliation': 'Department of Health Sciences, Swedish Winter Sports Research Centre, Mid Sweden University, Östersund, Sweden.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Steiner', 'Affiliation': 'Section for Elite Sport, Swiss Federal Institute of Sport, Magglingen, Switzerland.'}]",Frontiers in physiology,['10.3389/fphys.2020.00574']
2422,32547446,Reflecting on Existential Threats Elicits Self-Reported Negative Affect but No Physiological Arousal.,"There is mixed evidence whether reflecting on an existential threat increases negative affect and thereby elicits subjective arousal and physiological activation. Additionally, it is debated whether different existential and non-existential threats elicit different arousal responses, although systematic comparisons are lacking. The current study explored affective, subjective, and physiological arousal responses while comparing several existential threats with a non-existential threat and with a control condition. One-hundred-and-seventy-one undergraduate students were randomly allocated to one of four existential threat conditions: mortality salience (MS), freedom restriction, uncontrollability, and uncertainty; or to the non-existential threat condition: social-evaluative threat (SET); or to a control condition (TV salience). Self-reported positive/negative affect was measured before and after reflection, while subjective arousal and physiological activation (electrodermal, cardiovascular, and respiratory) were measured on a high time-scale during baseline and reflection. Results showed larger increases in self-reported negative affect, as compared to the control condition, for all existential threat conditions, while there were no differences between the control condition and threat conditions regarding positive affect, subjective arousal, skin conductance, respiratory rate, and respiratory sinus arrythmia. There were subtle differences between existential and non-existential threat conditions, most notably in affective responses. Correlations showed positive associations between negative affect and subjective arousal and between trait avoidance and subjective arousal. This study is the first to systematically compare affective, subjective, and physiological changes in arousal due to reflecting on different existential threats, as well as one non-existential threat. We showed that, as compared to a control condition, reflecting on threats has a large impact on negative affect, but no significant impact on positive affect, subjective arousal, and physiological activation.",2020,"Results showed larger increases in self-reported negative affect, as compared to the control condition, for all existential threat conditions, while there were no differences between the control condition and threat conditions regarding positive affect, subjective arousal, skin conductance, respiratory rate, and respiratory sinus arrythmia.",['One-hundred-and-seventy-one undergraduate students'],"['existential threat conditions: mortality salience (MS), freedom restriction, uncontrollability, and uncertainty; or to the non-existential threat condition: social-evaluative threat (SET); or to a control condition (TV salience']","['subjective arousal, skin conductance, respiratory rate, and respiratory sinus arrythmia', 'subjective arousal and physiological activation (electrodermal, cardiovascular, and respiratory', 'subjective arousal and between trait avoidance and subjective arousal', 'positive affect, subjective arousal, and physiological activation']","[{'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0003813', 'cui_str': 'Sinus arrhythmia'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",171.0,0.0175656,"Results showed larger increases in self-reported negative affect, as compared to the control condition, for all existential threat conditions, while there were no differences between the control condition and threat conditions regarding positive affect, subjective arousal, skin conductance, respiratory rate, and respiratory sinus arrythmia.","[{'ForeName': 'Eefje S', 'Initials': 'ES', 'LastName': 'Poppelaars', 'Affiliation': 'Department of Social Psychology, Salzburg University, Salzburg, Austria.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Klackl', 'Affiliation': 'Department of Social Psychology, Salzburg University, Salzburg, Austria.'}, {'ForeName': 'Daan T', 'Initials': 'DT', 'LastName': 'Scheepers', 'Affiliation': 'Department of Social and Organizational Psychology, Leiden University, Leiden, Netherlands.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Mühlberger', 'Affiliation': 'Department of Social Psychology, Salzburg University, Salzburg, Austria.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Jonas', 'Affiliation': 'Department of Social Psychology, Salzburg University, Salzburg, Austria.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.00962']
2423,32547459,"Design, Implementation and Evaluation of an Emotional Education Program: Effects on Academic Performance.","Background:  In recent decades, the amount of research on social and emotional learning programs in schools has increased significantly, showing a great number of positive student outcomes, including greater ability to perceive, understand and manage emotions, better attitudes about self and others, less aggressive and/or disruptive behavior, higher levels of psychological well-being and improvement in academic performance among others. The purpose of this research was the design and implementation of the OKAPI emotional education program. A multidimensional program based on cooperative learning methodology.  Methods:  86 students of Primary Education, from 3rd to 5th grade (45 students in the experimental unit and 41 in the control group).  Results:  The implementation of the OKAPI has a positive impact on academic achievement.  Conclusion:  This program shows the convenience of incorporating programs that can be integrated into school life and can be applied by the teaching staff using both social emotional learning and school climate approaches.",2020,This program shows the convenience of incorporating programs that can be integrated into school life and can be applied by the teaching staff using both social emotional learning and school climate approaches.,"['86 students of Primary Education, from 3rd to 5th grade (45 students in the experimental unit and 41 in the control group']",[],[],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],[],,0.0207236,This program shows the convenience of incorporating programs that can be integrated into school life and can be applied by the teaching staff using both social emotional learning and school climate approaches.,"[{'ForeName': 'María-José', 'Initials': 'MJ', 'LastName': 'Mira-Galvañ', 'Affiliation': 'Departament of Developmental Psychology and Didactics, University of Alicante, Alicante, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Gilar-Corbi', 'Affiliation': 'Departament of Developmental Psychology and Didactics, University of Alicante, Alicante, Spain.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.01100']
2424,32547478,"AMBAR, an Encouraging Alzheimer's Trial That Raises Questions.","Grifols' recent Alzheimer Management by Albumin Replacement (""AMBAR"") study investigated the effects of plasmapheresis with albumin replacement, plus intravenous immunoglobulin (IVIG) in some subjects, in patients with mild-to-moderate Alzheimer's disease (AD). AMBAR was a phase IIb trial in the United States and a phase III trial in Europe. There were three treatment groups (plasmapheresis with albumin replacement; plasmapheresis with low dose albumin and IVIG; plasmapheresis with high dose albumin and IVIG) and sham-treated controls. Disease progression in pooled treated patients was 66% less than control subjects based on ADAS-Cog scores ( p  = 0.06) and 52% less based on ADCS-ADL scores ( p  = 0.03). Moderate AD patients had 61% less progression, based on both ADAS-Cog and ADCS-ADL scores, than their sham-treated counterparts ( p -values 0.05 and 0.002), and their CDR-Sb scores declined 53% less than their sham-treated counterparts. However, ADAS-Cog and ADCS-ADL scores were not significantly different between actively-treated and sham-treated mild AD patients, although CDR-Sb scores improved vs. baseline for treated mild AD patients. Patients administered both IVIG and albumin had less reduction in brain glucose metabolism than sham-treated patients. Questions raised by these findings include: what mechanism(s) contributed to slowing of disease progression? Is this approach as effective in mild AD as in moderate AD? Must IVIG be included in the protocol? Does age, sex, or ApoE genotype influence treatment response? Does the protocol increase the risk for amyloid-related imaging abnormalities? How long does disease progression remain slowed post-treatment? A further study should allow this approach to be optimized.",2020,"Moderate AD patients had 61% less progression, based on both ADAS-Cog and ADCS-ADL scores, than their sham-treated counterparts ( p -values 0.05 and 0.002), and their CDR-Sb scores declined 53% less than their sham-treated counterparts.","[""patients with mild-to-moderate Alzheimer's disease (AD""]","['IVIG and albumin', 'plasmapheresis with albumin replacement; plasmapheresis with low dose albumin and IVIG; plasmapheresis with high dose albumin and IVIG) and sham-treated controls', 'plasmapheresis with albumin replacement, plus intravenous immunoglobulin (IVIG']","['CDR-Sb scores', 'Disease progression', 'ADCS-ADL scores', 'brain glucose metabolism', 'ADAS-Cog scores', 'ADAS-Cog and ADCS-ADL scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}]","[{'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0032134', 'cui_str': 'Plasmapheresis'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0021024', 'cui_str': 'Immunoglobulin, hypervariable region'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0001457', 'cui_str': 'Adenosine deaminase'}, {'cui': 'C0009738', 'cui_str': 'Congo'}]",,0.13338,"Moderate AD patients had 61% less progression, based on both ADAS-Cog and ADCS-ADL scores, than their sham-treated counterparts ( p -values 0.05 and 0.002), and their CDR-Sb scores declined 53% less than their sham-treated counterparts.","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Loeffler', 'Affiliation': 'Beaumont Research Institute, Department of Neurology, Beaumont Health, Royal Oak, MI, United States.'}]",Frontiers in neurology,['10.3389/fneur.2020.00459']
2425,32547621,The Effect of Lymphoedema Exercises and Foot Elevation on the Quality of Life of Patients with Elephantiasis.,"Filariasis is a chronic infectious disease caused by filarial worms. Swelling in the legs in patients with filariasis can result in a significantly lower quality of life. The recommended treatments for patients who experience swelling or lymphoedema are lymphoedema exercises and foot elevation. This research is a quantitative study with a quasi-experimental design including pre- and posttreatment tests with a control group. This study used a cluster sampling method, which is a nonprobability sampling technique. The samples in this study were 48 respondents divided into two groups: 24 respondents from the Nebe Village comprising the intervention group and 24 respondents from the Bangkoor Village comprising the control group. The intervention group conducted lymphoedema exercises and foot elevation three times a week for 15-20 min for 1 month and measured their quality of life using the LFSQQ questionnaire. Measurements of pitting edema and ankle diameter were also carried out. Paired  t -test revealed an improvement in the quality of life between pretest and posttest in the intervention and control groups ( p =0.001). The quality of life in the pre-post intervention group improved from 67.42 to 81.58. In addition, the quality of life in the pre-post control group only improved from 62.50 to 72.58. The level of pitting edema decreased from severe (+++) to moderate (++) and from mild (+) to normal (0), and there was no difference in ankle diameter in each group ( p =1.000). The quality of life improved before and after the administration of lymphoedema exercises and foot elevation for each group. Pitting edema decreased before and after lymphoedema exercises and foot elevation for each group. There was no decrease in ankle diameter after lymphoedema exercises and foot elevation in the intervention and control groups.",2020,Paired  t -test revealed an improvement in the quality of life between pretest and posttest in the intervention and control groups ( p =0.001).,"['patients who experience swelling or lymphoedema are lymphoedema exercises and foot elevation', '48 respondents divided into two groups: 24 respondents from the Nebe Village comprising the intervention group and 24 respondents from the Bangkoor Village comprising the control group', 'Patients with Elephantiasis']","['Lymphoedema Exercises and Foot Elevation', 'lymphoedema exercises']","['quality of life', 'ankle diameter after lymphoedema exercises and foot elevation', 'Quality of Life', 'ankle diameter', 'quality of life using the LFSQQ questionnaire', 'level of pitting edema', 'Pitting edema']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013882', 'cui_str': 'Elephantiasis'}]","[{'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0333243', 'cui_str': 'Pitting edema'}]",48.0,0.0207419,Paired  t -test revealed an improvement in the quality of life between pretest and posttest in the intervention and control groups ( p =0.001).,"[{'ForeName': 'Emirensiana', 'Initials': 'E', 'LastName': 'Watu', 'Affiliation': 'Magister of Nursing Student, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Supargiyono', 'Affiliation': 'Department of Parasitology, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Haryani', 'Affiliation': 'Department of Medical Surgical Nursing, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}]",Journal of tropical medicine,['10.1155/2020/6309630']
2426,32547649,"Corrigendum to ""Khorana score and thromboembolic risk in stage II-III colorectal cancer patients: a post hoc analysis from the adjuvant TOSCA trial"".",[This corrects the article DOI: 10.1177/1758835919899850.].,2020,[This corrects the article DOI: 10.1177/1758835919899850.].,['stage II-III colorectal cancer patients'],[],[],"[{'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],[],,0.030732,[This corrects the article DOI: 10.1177/1758835919899850.].,[],Therapeutic advances in medical oncology,['10.1177/1758835920932317']
2427,32547700,Effects of lifestyle interventions on rural patients with type 2 diabetes mellitus.,"BACKGROUND


The prevalence of type 2 diabetes mellitus (T2DM) is rising rapidly in rural areas, and lifestyle interventions can effectively reduce the blood glucose levels of patients with T2DM. However, current dietary and exercise guidelines are still at experimental stages and are difficult for subjects to understand and implement. The Human Metabolism Analyzer provides real life interventions for the prevention and treatment of T2DM, and our pilot research has demonstrated its effectiveness and good compliance.
AIM


To investigate the effect of and compliance with lifestyle interventions in rural patients with T2DM.
METHODS


A total of ten rural villages were randomly selected in Chaoshui Township, Penglai City, Shandong Province, China, to conduct health screening among residents aged 50 years or older. Each rural village represented a group, and 12 patients with T2DM were randomly selected from each group (total: 120) to participate in this study and receive real life lifestyle interventions and medication guidance. Lifestyle interventions included changing the meal order (A), postprandial activities (B), resistance exercise (C), and reverse abdominal breathing (D). Diabetes education was conducted at least once a month with a weekly phone follow-up to monitor exercise and diet. Waist circumference, blood pressure, body mass index (BMI), motor function, body composition, fasting blood glucose, and glycated hemoglobin (HbA1c) were analyzed before and 3 mo after the intervention. Moreover, patient compliance and adjustments of hypoglycemic drugs were evaluated.
RESULTS


A total of 109 subjects completed the study. The compliance rates for lifestyle interventions A, B, C, and D were 57.79%, 60.55%, 64.22%, and 75.23%, respectively. Among the subjects who received hypoglycemic drugs, the dose was reduced 2 to 3 times based on blood glucose in 54 (67.50%) subjects and was tapered and discontinued in 5 (6.25%) subjects within 3 mo, with no significant fluctuations in blood glucose after dose reduction and withdrawal. After lifestyle interventions, waist circumference, BMI, fasting blood glucose, and HbA1c significantly decreased ( P <  0.001); motor function and body composition also significantly improved ( P <  0.001).
CONCLUSION


For patients with T2DM, compliance to real-life lifestyle interventions is good, and the interventions significantly improve metabolic indicators such as waist circumference, BMI, blood pressure, HbA1c, body composition, and motor function. Some patients are able to taper or discontinue hypoglycemic drugs.",2020,"After lifestyle interventions, waist circumference, BMI, fasting blood glucose, and HbA1c significantly decreased ( P <  0.001); motor function and body composition also significantly improved ( P <  0.001).
","['109 subjects completed the study', 'rural patients with T2DM', 'A total of ten rural villages were randomly selected in Chaoshui Township, Penglai City, Shandong Province, China, to conduct health screening among residents aged 50 years or older', 'rural patients with type 2 diabetes mellitus', 'patients with T2DM', '12 patients with T2DM']","['real life lifestyle interventions and medication guidance', 'lifestyle interventions']","['metabolic indicators such as waist circumference, BMI, blood pressure, HbA1c, body composition, and motor function', 'blood glucose', 'waist circumference, BMI, fasting blood glucose, and HbA1c', 'motor function and body composition', 'meal order (A), postprandial activities (B), resistance exercise (C), and reverse abdominal breathing (D', 'Waist circumference, blood pressure, body mass index (BMI), motor function, body composition, fasting blood glucose, and glycated hemoglobin (HbA1c', 'blood glucose levels']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0220908', 'cui_str': 'Screening procedure'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0231898', 'cui_str': 'Diaphragmatic breathing'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}]",10.0,0.0116737,"After lifestyle interventions, waist circumference, BMI, fasting blood glucose, and HbA1c significantly decreased ( P <  0.001); motor function and body composition also significantly improved ( P <  0.001).
","[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Internal Medicine, Yantaishan Hospital, Yantai 264025, Shandong Province, China.'}, {'ForeName': 'Xiao-Li', 'Initials': 'XL', 'LastName': 'Mu', 'Affiliation': 'Department of Internal Medicine, Yantaishan Hospital, Yantai 264025, Shandong Province, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Internal Medicine, Yantaishan Hospital, Yantai 264025, Shandong Province, China.'}, {'ForeName': 'Hai-Ping', 'Initials': 'HP', 'LastName': 'Jiang', 'Affiliation': 'Department of Internal Medicine, Yantaishan Hospital, Yantai 264025, Shandong Province, China.'}, {'ForeName': 'Shan-Shan', 'Initials': 'SS', 'LastName': 'Li', 'Affiliation': 'Department of Internal Medicine, Yantaishan Hospital, Yantai 264025, Shandong Province, China.'}, {'ForeName': 'Ge', 'Initials': 'G', 'LastName': 'Yan', 'Affiliation': 'Department of Internal Medicine, Yantaishan Hospital, Yantai 264025, Shandong Province, China.'}, {'ForeName': 'Ying-Ying', 'Initials': 'YY', 'LastName': 'Hua', 'Affiliation': 'Department of Internal Medicine, Yantaishan Hospital, Yantai 264025, Shandong Province, China.'}, {'ForeName': 'Xue-Yi', 'Initials': 'XY', 'LastName': 'Ren', 'Affiliation': 'Department of Internal Medicine, Yantaishan Hospital, Yantai 264025, Shandong Province, China.'}, {'ForeName': 'Li-Xia', 'Initials': 'LX', 'LastName': 'Xing', 'Affiliation': 'Department of Internal Medicine, Yantaishan Hospital, Yantai 264025, Shandong Province, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Department of Internal Medicine, Yantaishan Hospital, Yantai 264025, Shandong Province, China.'}, {'ForeName': 'Shu-Dong', 'Initials': 'SD', 'LastName': 'Zhang', 'Affiliation': 'Department of Internal Medicine, Yantaishan Hospital, Yantai 264025, Shandong Province, China.'}, {'ForeName': 'Yu-Chi', 'Initials': 'YC', 'LastName': 'Zhao', 'Affiliation': 'Department of Osteoarthropathy, Yantaishan Hospital, Yantai 264025, Shandong Province, China. zhaoyuchizyc@163.com.'}]",World journal of diabetes,['10.4239/wjd.v11.i6.261']
2428,32547735,Prevention of severe infectious complications after colorectal surgery using oral non-absorbable antimicrobial prophylaxis: results of a multicenter randomized placebo-controlled clinical trial.,"Background


Surgical site infections (SSIs) are common complications after colorectal surgery. Oral non-absorbable antibiotic prophylaxis (OAP) can be administered preoperatively to reduce the risk of SSIs. Its efficacy without simultaneous mechanical cleaning is unknown.
Methods


The Precaution trial was a double-blind, placebo-controlled randomized clinical trial conducted in six Dutch hospitals. Adult patients who underwent elective colorectal surgery were randomized to receive either a three-day course of preoperative OAP with tobramycin and colistin or placebo. The primary composite endpoint was the incidence of deep SSI or mortality within 30 days after surgery. Secondary endpoints included both infectious and non-infectious complications at 30 days and six months after surgery.
Results


The study was prematurely ended due to the loss of clinical equipoise. At that time, 39 patients had been randomized to active OAP and 39 to placebo, which reflected 8.1% of the initially pursued sample size. Nine (11.5%) patients developed the primary outcome, of whom four had been randomized to OAP (4/39; 10.3%) and five to placebo (5/39; 12.8%). This corresponds to a risk ratio in the intention-to-treat analysis of 0.80 (95% confidence interval (CI) 0.23-2.78). In the per-protocol analysis, the relative risk was 0.64 (95% CI 0.12-3.46).
Conclusions


Observational data emerging during the study provided new evidence for the effectiveness of OAP that changed both the clinical and medical ethical landscape for infection prevention in colorectal surgery. We therefore consider it unethical to continue randomizing patients to placebo. We recommend the implementation of OAP in clinical practice and continuing monitoring of infection rates and antibiotic susceptibilities.
Trial registration


The PreCaution trial is registered in the Netherlands Trial Register under NL5932 (previously: NTR6113) as well as in the EudraCT register under 2015-005736-17.",2020,This corresponds to a risk ratio in the intention-to-treat analysis of 0.80 (95% confidence interval (CI) 0.23-2.78).,"['Adult patients who underwent elective colorectal surgery', 'six Dutch hospitals', '39 patients had been randomized to active OAP and 39 to']","['OAP', 'colorectal surgery using oral non-absorbable antimicrobial prophylaxis', 'preoperative OAP with tobramycin and colistin or placebo', 'Oral non-absorbable antibiotic prophylaxis (OAP', 'placebo']","['infectious and non-infectious complications', 'incidence of deep SSI or mortality', 'relative risk']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C1527415', 'cui_str': 'Oral route'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0040341', 'cui_str': 'Tobramycin'}, {'cui': 'C0009316', 'cui_str': 'Colistin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}]",,0.768962,This corresponds to a risk ratio in the intention-to-treat analysis of 0.80 (95% confidence interval (CI) 0.23-2.78).,"[{'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Mulder', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Kluytmans-van den Bergh', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Vlaminckx', 'Affiliation': 'Department of Medical Microbiology, St. Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Roos', 'Affiliation': 'Department of Surgery, Reinier de Graaf Gasthuis, Delft, The Netherlands.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'de Smet', 'Affiliation': 'Department of Intensive Care Medicine, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'de Vos Tot Nederveen Cappel', 'Affiliation': 'Department of Surgery, Admiraal de Ruyter Hospital, Goes, The Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Verheijen', 'Affiliation': 'Department of Surgery, Meander Medical Center, Amersfoort, The Netherlands.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Brandt', 'Affiliation': 'Department of Surgery, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Smits', 'Affiliation': 'Department of Surgery, St. Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'van der Vorm', 'Affiliation': 'Department of Medical Microbiology, Reinier de Graaf Gasthuis, Delft, The Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Bathoorn', 'Affiliation': 'Department of Medical Microbiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Boudewijn', 'Initials': 'B', 'LastName': 'van Etten', 'Affiliation': 'Department of Surgery, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Jacobien', 'Initials': 'J', 'LastName': 'Veenemans', 'Affiliation': 'Department of Medical Microbiology, Admiraal de Ruyter Hospital, Goes, the Netherlands.'}, {'ForeName': 'Annemarie', 'Initials': 'A', 'LastName': 'Weersink', 'Affiliation': 'Department of Medical Microbiology, Meander Medical Center, Amersfoort, The Netherlands.'}, {'ForeName': 'Margreet', 'Initials': 'M', 'LastName': 'Vos', 'Affiliation': 'Department of Microbiology and Infectious Diseases, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': ""van 't Veer"", 'Affiliation': 'Department of Clinical Pharmacy, Amphia Hospital, Breda, The Netherlands.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Nikolakopoulos', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Bonten', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Kluytmans', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}]",Antimicrobial resistance and infection control,['10.1186/s13756-020-00745-2']
2429,32547753,Intensive fever control using a therapeutic normothermia protocol in patients with febrile early septic shock: A randomized feasibility trial and exploration of the immunomodulatory effects.,"Objectives


Fever control has been shown to reduce short-term mortality in patients with septic shock. This study aimed to explore the feasibility of early intensive fever control in patients with septic shock and to assess the immunomodulatory effects of this intervention.
Methods


In this single-center, randomized, open-label trial, febrile patients with septic shock presenting to the emergency department were assigned to either a standard fever control or therapeutic normothermia group. Therapeutic normothermia involved intensive fever control in maintaining normothermia below 37°C. The primary outcome was the feasibility of fever control for 24 h. Secondary outcomes included changes in immunomodulatory biomarkers and adverse events.
Results


Fifteen patients were enrolled and analyzed. Fever control was comparable in both groups, but significantly more patients in the therapeutic normothermia group experienced shivering ( p  = 0.007). Both groups demonstrated increased C-reactive protein and unchanged neutrophil chemotaxis and CD11b expression. The therapeutic normothermia group revealed significant decreased IL-6 and IL-10. The standard fever control group significantly expressed increased monocytic human leukocyte antigen. There were no significant differences between the groups in terms of immunomodulation.
Conclusions


Therapeutic normothermia was feasible in patients with febrile septic shock but was not superior to standard fever control in terms of average body temperature and host defense function. Shivering was more frequent in the therapeutic normothermia group.
Trial registration


Thai Clinical Trials Registry number: TCTR20160321001.",2020,"Fever control was comparable in both groups, but significantly more patients in the therapeutic normothermia group experienced shivering ( p  = 0.007).","['patients with febrile early septic shock', 'patients with septic shock', 'patients with febrile septic shock', 'febrile patients with septic shock presenting to the emergency department', 'Fifteen patients were enrolled and analyzed']","['standard fever control or therapeutic normothermia group', 'therapeutic normothermia protocol']","['IL-6 and IL-10', 'shivering', 'Shivering', 'changes in immunomodulatory biomarkers and adverse events', 'monocytic human leukocyte antigen', 'feasibility of fever control', 'C-reactive protein and unchanged neutrophil chemotaxis and CD11b expression', 'Fever control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0445103', 'cui_str': 'Normothermia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0036973', 'cui_str': 'Shivering or rigors'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0019629', 'cui_str': 'Class I Histocompatibility Antigens'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0442739', 'cui_str': 'No status change'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C1136310', 'cui_str': 'Lymphocyte antigen CD11b'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",15.0,0.113321,"Fever control was comparable in both groups, but significantly more patients in the therapeutic normothermia group experienced shivering ( p  = 0.007).","[{'ForeName': 'Jutamas', 'Initials': 'J', 'LastName': 'Saoraya', 'Affiliation': 'Department of Emergency Medicine, King Chulalongkorn Memorial Hospital, The Thai Red Cross Society, Bangkok, Thailand.'}, {'ForeName': 'Khrongwong', 'Initials': 'K', 'LastName': 'Musikatavorn', 'Affiliation': 'Department of Emergency Medicine, King Chulalongkorn Memorial Hospital, The Thai Red Cross Society, Bangkok, Thailand.'}, {'ForeName': 'Patima', 'Initials': 'P', 'LastName': 'Puttaphaisan', 'Affiliation': 'Department of Emergency Medicine, King Chulalongkorn Memorial Hospital, The Thai Red Cross Society, Bangkok, Thailand.'}, {'ForeName': 'Atthasit', 'Initials': 'A', 'LastName': 'Komindr', 'Affiliation': 'Department of Emergency Medicine, King Chulalongkorn Memorial Hospital, The Thai Red Cross Society, Bangkok, Thailand.'}, {'ForeName': 'Nattachai', 'Initials': 'N', 'LastName': 'Srisawat', 'Affiliation': 'Division of Nephrology, Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}]",SAGE open medicine,['10.1177/2050312120928732']
2430,32547806,Effects of a Mobile-App-Based Self-Management Support Program For Elderly Hemodialysis Patients.,"Objectives


To identify the effects of a mobile-app-based self-management program for elderly hemodialysis patients on their sick-role behavior, basic psychological needs, and self-efficacy.
Methods


A nonequivalent control group with a non-synchronized design was utilized, and 60 participants (30 in each of the experimental and control groups) were recruited from Chungnam National University Hospital from March to August 2018. The program consisted of continuous training on how to use the mobile-app, self-checking via the app, message transfer through Electronic Medical Records, and feedback. The control group received the usual care. Data were analyzed using the χ 2 -test, the  t -test, the repeated-measures ANOVA, and the McNemar test. A formalized messaging program was developed, and the app was developed with consideration of the specific physical and cognitive limitations of the elderly.
Results


Comparisons were conducted between the experimental (n = 28) and control (n = 28) groups. Statistically significant increases in sick-role behavior, basic psychological needs, and self-efficacy were found in the experimental group ( p  < 0.001). Physiological parameters were maintained within the normal ranges in the experimental group, and the number of non-adherent patients decreased, although the change was not statistically significant.
Conclusions


The mobile-app-based self-management program developed in this study increased the sick-role behavior, basic psychological needs, and self-efficacy of elderly hemodialysis patients, while physiological parameters were maintained within the normal range. Future studies are needed to develop management systems for high-risk hemodialysis patients and family-sharing apps to manage non-adherent patients.",2020,"Statistically significant increases in sick-role behavior, basic psychological needs, and self-efficacy were found in the experimental group ( p  < 0.001).","['Elderly Hemodialysis Patients', 'elderly hemodialysis patients', 'high-risk hemodialysis patients and family-sharing apps to manage non-adherent patients', '60 participants (30 in each of the experimental and control groups) were recruited from Chungnam National University Hospital from March to August 2018']","['Mobile-App-Based Self-Management Support Program', 'mobile-app-based self-management program', 'usual care']","['sick-role behavior, basic psychological needs, and self-efficacy']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0037051', 'cui_str': 'Sick Role'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.0172681,"Statistically significant increases in sick-role behavior, basic psychological needs, and self-efficacy were found in the experimental group ( p  < 0.001).","[{'ForeName': 'Youngsoon', 'Initials': 'Y', 'LastName': 'Min', 'Affiliation': 'Hemodialysis Unit, Chungnam National University Hospital, Daejeon, Korea.'}, {'ForeName': 'Myonghwa', 'Initials': 'M', 'LastName': 'Park', 'Affiliation': 'College of Nursing, Chungnam National University, Daejeon, Korea.'}]",Healthcare informatics research,['10.4258/hir.2020.26.2.93']
2431,32547844,Do Patterns of Instability or Severity of Psychopathology During Screening Predict Relapse in Schizophrenic Outpatient Subjects with Moderate to Severe Negative Symptoms Assigned to Placebo?,"Background:  Patients with schizophrenia who, prior to inclusion in placebo-controlled trials, experience the most severe and/or unstable symptoms might be more likely to manifest symptomatic worsening upon antipsychotic discontinuation.  Methods:  This retrospective analysis included all randomized patients assigned to placebo (n=83) in a 12-week, double-blind, placebo-controlled outpatient trial of MIN-101 (roluperidone) for the treatment of negative symptoms in schizophrenia. The following risk factors were defined for exacerbation: instability between screening and baseline defined operationally as patients with the highest 10 percent of absolute change from the screening visit to baseline in the Positive and Negative Syndrome Scale (PANSS) total or one of the five PANSS Marder factors; screening or baseline severity in PANSS total or one of the five PANSS Marder factors; and gender and age. We used two operational criteria of relapse and the odds ratios of meeting the relapse criteria were calculated for each risk factor.  Results:  The odds of meeting one of the operational thresholds for relapse after antipsychotic discontinuation were not statistically significantly increased in the subjects who were unstable on the PANSS total or on one of the five PANSS Marder factors before antipsychotic discontinuation. Further, the severity of PANSS total and Marder factor scores at screening and baseline were not statistically significantly associated with odds of relapse. Neither age nor gender had any effect on relapse rates.  Conclusion:  Mild to moderate symptomatic variations in the severity of symptoms during screening and more severe symptomology at baseline as measured by the PANSS were not predictive of increased risk of subsequent relapse in schizophrenic patients.",2020,The odds of meeting one of the operational thresholds for relapse after antipsychotic discontinuation were not statistically significantly increased in the subjects who were unstable on the PANSS total or on one of the five PANSS Marder factors before antipsychotic discontinuation.,"['Patients with schizophrenia who, prior to inclusion in placebo-controlled trials, experience the most severe and/or unstable symptoms might be more likely to manifest symptomatic worsening upon antipsychotic discontinuation', 'Schizophrenic Outpatient Subjects with Moderate to Severe Negative Symptoms Assigned to']","['MIN-101 (roluperidone', 'Placebo', 'placebo']","['severity of PANSS total and Marder factor scores', 'severe symptomology', 'Instability or Severity of Psychopathology', 'relapse rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0443343', 'cui_str': 'Unstable status'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C4547356', 'cui_str': 'MIN-101'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",,0.108905,The odds of meeting one of the operational thresholds for relapse after antipsychotic discontinuation were not statistically significantly increased in the subjects who were unstable on the PANSS total or on one of the five PANSS Marder factors before antipsychotic discontinuation.,"[{'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Daniel', 'Affiliation': 'Dr. Daniel is with Signant Health in Mclean, Virginia.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Kott', 'Affiliation': 'Dr. Daniel is with Signant Health in Mclean, Virginia.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Saoud', 'Affiliation': 'Dr. Daniel is with Signant Health in Mclean, Virginia.'}, {'ForeName': 'Remy', 'Initials': 'R', 'LastName': 'Luthringer', 'Affiliation': 'Dr. Daniel is with Signant Health in Mclean, Virginia.'}, {'ForeName': 'Vadym', 'Initials': 'V', 'LastName': 'Rud', 'Affiliation': 'Dr. Daniel is with Signant Health in Mclean, Virginia.'}, {'ForeName': 'Andrii', 'Initials': 'A', 'LastName': 'Skyrpnikov', 'Affiliation': 'Dr. Daniel is with Signant Health in Mclean, Virginia.'}, {'ForeName': 'Rodica', 'Initials': 'R', 'LastName': 'Stan', 'Affiliation': 'Dr. Daniel is with Signant Health in Mclean, Virginia.'}, {'ForeName': 'Veselin', 'Initials': 'V', 'LastName': 'Palazov', 'Affiliation': 'Dr. Daniel is with Signant Health in Mclean, Virginia.'}, {'ForeName': 'Xingmei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Dr. Daniel is with Signant Health in Mclean, Virginia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Davidson', 'Affiliation': 'Dr. Daniel is with Signant Health in Mclean, Virginia.'}]",Innovations in clinical neuroscience,[]
2432,32547872,Nebulized dexmedetomidine improves pulmonary shunt and lung mechanics during one-lung ventilation: a randomized clinical controlled trial.,"Background


Dexmedetomidine (Dex), a selective a 2 -adrenergic receptor agonist, has been previously reported to attenuate intrapulmonary shunt during one-lung ventilation (OLV) and to alleviate bronchoconstriction. However, the therapeutic effects of nebulized Dex on pulmonary shunt and lung mechanics during OLV have not been evaluated. Here we determine whether nebulized dexmedetomidine improved pulmonary shunt and lung mechanics in patients undergoing elective thoracic surgery in a prospective randomized controlled clinical trial.
Methods


One hundred and twenty-eight patients undergoing elective thoracoscopic surgery were included in this study and randomly divided into four groups: 0.9% saline (Placebo group), 0.5 µg/kg (Dex 0.5  group), 1 µg/kg (Dex 1  group) and 2 µg/kg (Dex 2 group) dexmedetomidine. After bronchial intubation, patients received different nebulized doses of dexmedetomidine (0.5 µg/kg, 1 µg/kg and 2 µg/kg) or 0.9% saline placebo during two-lung ventilation(TLV). OLV was initiated 15 min after bronchial intubation. Anesthesia was maintained with intravenous infusion of cisatracurium and propofol. Bispectral Index values were maintained within 40-50 by adjusting the infusion of propofol in all groups. Arterial blood gas samples and central venous blood gas samples were taken as follows: 15 min after bronchial intubation during two-lung ventilation (TLV 15 ), after 30 and 60 min of OLV (OLV 30 and OLV 60 , respectively) and 15 min after reinstitution of TLV (ReTLV). Dynamic compliance was also calculated at TLV 15 , OLV 30 , OLV 60  and ReTLV.
Results


Dex decreased the requirement of propofol in a dose-dependent manner( P  = 0.000). Heart rate (HR) and mean arterial pressure (MAP) displayed no significant difference among groups ( P  = 0.397 and 0.863). Compared with the placebo group, Dex administered between 0.5 and 2 µg/kg increased partial pressure of oxygen (P a O 2 ) significantly at OLV 30  and OLV 60 ( P  = 0.000); however, Dex administered between 1 and 2 µg/kg decreased pulmonary shunt fraction (Q s /Q t ) at OLV 30  and OLV 60 ( P  = 0.000). Compared with the placebo group, there were significant increases with dynamic compliance (Cdyn) after OLV in Dex 0.5 , Dex 1  and Dex 2 group( P  = 0.000).  Conclusions.  Nebulized dexmedetomidine improved oxygenation not only by decreasing pulmonary shunt but also by improving lung compliance during OLV, which may be effective in managing OLV.",2020,Heart rate (HR) and mean arterial pressure (MAP) displayed no significant difference among groups ( P  = 0.397 and 0.863).,"['one-lung ventilation', 'patients undergoing elective thoracic surgery', 'One hundred and twenty-eight patients undergoing elective thoracoscopic surgery']","['Dexmedetomidine (Dex', 'cisatracurium and propofol', 'placebo', 'nebulized Dex', 'saline placebo', 'saline (Placebo', 'Nebulized dexmedetomidine', '0.5 µg/kg (Dex 0.5  group), 1 µg/kg (Dex 1  group) and 2 µg/kg (Dex 2 group) dexmedetomidine', 'propofol', 'dexmedetomidine', 'Dex', 'nebulized dexmedetomidine']","['pulmonary shunt and lung mechanics', 'Arterial blood gas samples and central venous blood gas samples', 'Bispectral Index values', 'lung compliance', 'requirement of propofol', 'partial pressure of oxygen', 'Heart rate (HR) and mean arterial pressure (MAP', 'pulmonary shunt fraction (Q s /Q', 'OLV', 'Dynamic compliance', 'dynamic compliance (Cdyn']","[{'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0751551', 'cui_str': 'Thoracoscopic Surgical Procedures'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C1096766', 'cui_str': 'Cisatracurium'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0542331', 'cui_str': 'Shunt'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0444466', 'cui_str': 'Central venous'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0024112', 'cui_str': 'Lung compliance'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0429680', 'cui_str': 'Dynamic compliance'}]",128.0,0.112907,Heart rate (HR) and mean arterial pressure (MAP) displayed no significant difference among groups ( P  = 0.397 and 0.863).,"[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'The Department of Anesthesiology, The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Gao', 'Affiliation': ""The Department of Anesthesiology, The Affiliated Wuxi People's Hospital of Nanjing Medical University Wuxi, Jiangsu, China.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""The Department of Anesthesiology, The Affiliated Wuxi People's Hospital of Nanjing Medical University Wuxi, Jiangsu, China.""}, {'ForeName': 'Chunxiao', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': ""The Department of Anesthesiology, The Affiliated Wuxi People's Hospital of Nanjing Medical University Wuxi, Jiangsu, China.""}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'The Department of Anesthesiology, The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China.'}]",PeerJ,['10.7717/peerj.9247']
2433,32548143,Clinical application of ultrasound-guided selective proximal and distal brachial plexus block in rapid rehabilitation surgery for hand trauma.,"BACKGROUND


Anesthesia plays an essential role in the successful surgical procedures for hand trauma. Compared with general anesthesia, brachial plexus block shows lots of benefits for the upper extremity. Specifically, ultrasound-guided selective proximal and distal brachial plexus block may overcome the issues of incomplete block and failure of anesthesia in such circumstances. The present study assessed the efficacy of ultrasound-guided selective proximal and distal brachial plexus block in clinical practice.
AIM


To explore the efficacy of ultrasound-guided selective proximal and distal brachial plexus block in rapid recovery surgery for hand trauma.
METHODS


A total of 68 patients with traumatic hand injuries treated at our hospital from January 2018 to June 2019 were selected. They were divided into an observation group and a control group with 34 patients in each group. The observation group underwent selective brachial plexus block guided by ultrasound and the control group underwent conventional brachial plexus block. The analgesic efficacy, intraoperative complications, wound healing time, and length of hospital stay were compared between the two groups under different anesthesia.
RESULTS


The percentage of cases with analgesia graded as ""excellent or very good"" was higher in the observation group than in the control group ( P  < 0.05). Moreover, the incidence of intraoperative complications was lower and the wound healing time and length of hospital stay were shorter in the observation group than in the control group ( P  < 0.05).
CONCLUSION


Ultrasound-guided selective proximal and distal brachial plexus block has remarkable analgesic efficacy in patients with traumatic hand injuries. It can reduce the incidence of intraoperative complications, promote wound healing, and shorten the length of hospital stay.",2020,"Moreover, the incidence of intraoperative complications was lower and the wound healing time and length of hospital stay were shorter in the observation group than in the control group ( P  < 0.05).
","['patients with traumatic hand injuries', '68 patients with traumatic hand injuries treated at our hospital from January 2018 to June 2019 were selected']","['Ultrasound-guided selective proximal and distal brachial plexus block', 'ultrasound-guided selective proximal and distal brachial plexus block', 'selective brachial plexus block guided by ultrasound and the control group underwent conventional brachial plexus block']","['wound healing time and length of hospital stay', 'incidence of intraoperative complications', 'percentage of cases with analgesia graded as ""excellent or very good', 'analgesic efficacy', 'incidence of intraoperative complications, promote wound healing, and shorten the length of hospital stay', 'analgesic efficacy, intraoperative complications, wound healing time, and length of hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0018571', 'cui_str': 'Injury of hand'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0394697', 'cui_str': 'Injection of anesthetic agent into brachial plexus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C3641222', 'cui_str': 'Very good'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}]",68.0,0.0199269,"Moreover, the incidence of intraoperative complications was lower and the wound healing time and length of hospital stay were shorter in the observation group than in the control group ( P  < 0.05).
","[{'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Sichuan Orthopedic Hospital, Chengdu 610041, Sichuan Province, China. zhangjin987654@126.com.'}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Sichuan Orthopedic Hospital, Chengdu 610041, Sichuan Province, China.'}, {'ForeName': 'Hai-Bin', 'Initials': 'HB', 'LastName': 'Jia', 'Affiliation': 'Department of Anesthesiology, Sichuan Orthopedic Hospital, Chengdu 610041, Sichuan Province, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Sichuan Orthopedic Hospital, Chengdu 610041, Sichuan Province, China.'}]",World journal of clinical cases,['10.12998/wjcc.v8.i11.2137']
2434,32548144,High flux hemodialysis in elderly patients with chronic kidney failure.,"BACKGROUND


Hemodialysis is an advanced blood purification technique to manage kidney failure. However, for conventional hemodialysis, the high prevalence of dyslipidemia may cause cardiovascular diseases and an increase in mortality. Moreover, toxins accumulating in the body over time may induce some complications. High flux hemodialysis can effectively improve disease indexes and clinical symptoms.
AIM


To investigate the efficacy of high flux hemodialysis in elderly patients with chronic kidney failure (CKF).
METHODS


A total of 66 elderly patients with CKF who were admitted to our hospital from October 2017 to October 2018 were included in the study. According to the therapies they received, the patients were divided into a study group and a control group with 33 patients in each group. The study group received high flux hemodialysis and the control group received conventional dialysis treatment. Kidney function, toxin levels in serum, and complications were compared in the two groups.
RESULTS


Before the treatment, there was no significant difference in kidney function, β2-microglobulin, or blood urea nitrogen between the two groups ( P  > 0.05). In contrast, kidney function was better in the study group than in the control group after the treatment ( P  < 0.05). In addition, the study group had significantly lower parathyroid hormone and serum cystatin C than the control group ( P  < 0.05). The incidence of complications was 8.57% in the study group, which was lower than that of the control group (20.00%;  P  < 0.05).
CONCLUSION


High flux hemodialysis may improve kidney function and reduce toxin levels in serum and the incidence of complications in elderly patients with CKF.",2020,"Before the treatment, there was no significant difference in kidney function, β2-microglobulin, or blood urea nitrogen between the two groups ( P  > 0.05).","['elderly patients with chronic kidney failure (CKF', 'elderly patients with chronic kidney failure', '66 elderly patients with CKF who were admitted to our hospital from October 2017 to October 2018 were included in the study', 'elderly patients with CKF']","['high flux hemodialysis', 'high flux hemodialysis and the control group received conventional dialysis treatment']","['parathyroid hormone and serum cystatin C', 'Kidney function, toxin levels in serum, and complications', 'kidney function', 'mortality', 'toxin levels', 'incidence of complications', 'kidney function, β2-microglobulin, or blood urea nitrogen']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0040549', 'cui_str': 'Toxin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}]",66.0,0.0129219,"Before the treatment, there was no significant difference in kidney function, β2-microglobulin, or blood urea nitrogen between the two groups ( P  > 0.05).","[{'ForeName': 'Hai-Yan', 'Initials': 'HY', 'LastName': 'Xue', 'Affiliation': ""Dialysis Center, The Fourth People's Hospital of Shaanxi, Xi'an 710043, Shaanxi Province, China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Duan', 'Affiliation': ""Department of Kidney Diseases, Dialysis Center, Shaanxi Provincial People's Hospital, Xi'an 710068, Shaanxi Province, China.""}, {'ForeName': 'Zhen-Jiang', 'Initials': 'ZJ', 'LastName': 'Li', 'Affiliation': ""Department of Kidney Diseases, Dialysis Center, Shaanxi Provincial People's Hospital, Xi'an 710068, Shaanxi Province, China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Du', 'Affiliation': ""Department of Kidney Diseases, Dialysis Center, Shaanxi Provincial People's Hospital, Xi'an 710068, Shaanxi Province, China. seasonn@163.com.""}]",World journal of clinical cases,['10.12998/wjcc.v8.i11.2144']
2435,32548299,Tumor Sphericity Predicts Response in Neoadjuvant Chemotherapy for Invasive Breast Cancer.,"This retrospective study examined magnetic resonance imaging (MRI)-derived tumor sphericity (SPH) as a quantitative measure of breast tumor morphology, and investigated the association between SPH and reader-assessed morphological pattern (MP). In addition, association of SPH with pathologic complete response was evaluated in patients enrolled in an adaptively randomized clinical trial designed to rapidly identify new agents for breast cancer. All patients underwent MRI examinations at multiple time points during the treatment. SPH values from pretreatment (T0) and early-treatment (T1) were investigated in this study. MP on T0 dynamic contrast-enhanced MRI was ranked from 1 to 5 in 220 patients. Mean SPH values decreased with the increased order of MP. SPH was higher in patients with pathologic complete response than in patients without (difference at T0: 0.04, 95% confidence interval [CI]: 0.02-0.05,  P  < .001; difference at T1: 0.03, 95% CI: 0.02-0.04,  P  < .001). The area under the receiver operating characteristic curve was estimated as 0.61 (95% CI, 0.57-0.65) at T0 and 0.58 (95% CI, 0.55-0.62) at T1. When the analysis was performed by cancer subtype defined by hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2) status, highest area under the receiver operating characteristic curve were observed in HR-/HER2+: 0.67 (95% CI, 0.54-0.80) at T0, and 0.63 (95% CI, 0.51-0.76) at T1. Tumor SPH showed promise to quantify MRI MPs and as a biomarker for predicting treatment outcome at pre- or early-treatment time points.",2020,Tumor SPH showed promise to quantify MRI MPs and as a biomarker for predicting treatment outcome at pre- or early-treatment time points.,['Invasive Breast Cancer'],"['Neoadjuvant Chemotherapy', 'magnetic resonance imaging (MRI)-derived tumor sphericity (SPH']","['SPH', 'MP on T0 dynamic contrast-enhanced MRI', 'SPH values', 'area under the receiver operating characteristic curve', 'Mean SPH values', 'hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2) status, highest area under the receiver operating characteristic curve']","[{'cui': 'C0853879', 'cui_str': 'Invasive carcinoma of breast'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]","[{'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205250', 'cui_str': 'High'}]",220.0,0.0801601,Tumor SPH showed promise to quantify MRI MPs and as a biomarker for predicting treatment outcome at pre- or early-treatment time points.,"[{'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Newitt', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Bo La', 'Initials': 'B', 'LastName': 'Yun', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Ella F', 'Initials': 'EF', 'LastName': 'Jones', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Vignesh', 'Initials': 'V', 'LastName': 'Arasu', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Wilmes', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Gibbs', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Alex Anh-Tu', 'Initials': 'AA', 'LastName': 'Nguyen', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Natsuko', 'Initials': 'N', 'LastName': 'Onishi', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kornak', 'Affiliation': 'Departments of Epidemiology and Biostatistics; and.'}, {'ForeName': 'Bonnie N', 'Initials': 'BN', 'LastName': 'Joe', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Esserman', 'Affiliation': 'Surgery, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Nola M', 'Initials': 'NM', 'LastName': 'Hylton', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, San Francisco, CA.'}]","Tomography (Ann Arbor, Mich.)",['10.18383/j.tom.2020.00016']
2436,32541215,Direct Oral Feeding After a Minimally Invasive Esophagectomy: A Single-Center Prospective Cohort Study.,"OBJECTIVE


The aim of this single-center cohort study was to compare direct oral feeding (DOF) to standard of care after a minimally invasive esophagectomy (MIE) performed in a center with a stable and acceptable postoperative complication rate.
BACKGROUND


A recent multicenter, international randomized controlled trial showed that DOF following a MIE is comparable to standard of care (nil-by-mouth). However, the effect of DOF was potentially influenced by postoperative complications.
METHODS


Patients in this single-center prospective cohort study received either DOF (intervention) or nil-by-mouth for 5 days postoperative and tube feeding (standard of care, control group) following a MIE with intrathoracic anastomosis. Primary outcome was time to functional recovery and length of hospital stay. Secondary outcomes included anastomotic leakage, pneumonia, and other surgical complications.
RESULTS


Baseline characteristics were similar in the intervention (n = 85) and control (n = 111) group. Median time to functional recovery was 7 and 9 days in the intervention and control group (P < 0.001), respectively. Length of hospital stay was 8 versus 10 days (P < 0.001), respectively. Thirty-day postoperative complication rate was significantly reduced in the intervention group (57.6% vs 73.0%, P = 0.024). Chyle leakage only occurred in the control group (18.9%, P < 0.001). Anastomotic leakage, pneumonia, and other postoperative complications did not differ between groups.
CONCLUSION


Direct oral feeding following a MIE results in a faster time to functional recovery and lower 30-day postoperative complication rate compared to patients that were orally fasted.",2020,"Median time to functional recovery was 7 and 9 days in the intervention and control group (P < 0.001), respectively.",['Patients in this single-center prospective cohort study received either'],"['direct oral feeding (DOF) to standard of care after a minimally invasive esophagectomy (MIE', 'DOF (intervention) or nil-by-mouth for 5 days postoperative and tube feeding (standard of care, control group) following a MIE with intrathoracic anastomosis', 'Minimally Invasive Esophagectomy', 'DOF', 'Direct Oral Feeding']","['time to functional recovery and length of hospital stay', 'anastomotic leakage, pneumonia, and other surgical complications', 'Anastomotic leakage, pneumonia, and other postoperative complications', 'Thirty-day postoperative complication rate', 'Median time to functional recovery', 'Length of hospital stay', '30-day postoperative complication rate', 'Chyle leakage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0419179', 'cui_str': 'Nil by mouth'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0595836', 'cui_str': 'Intrathoracic route'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0398372', 'cui_str': 'Escape of lymph'}]",,0.19164,"Median time to functional recovery was 7 and 9 days in the intervention and control group (P < 0.001), respectively.","[{'ForeName': 'Laura F C', 'Initials': 'LFC', 'LastName': 'Fransen', 'Affiliation': 'Department of Surgery, Catharina Hospital, Eindhoven, the Netherlands.'}, {'ForeName': 'Thijs H J B', 'Initials': 'THJB', 'LastName': 'Janssen', 'Affiliation': ''}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Aarnoudse', 'Affiliation': ''}, {'ForeName': 'Grard A P', 'Initials': 'GAP', 'LastName': 'Nieuwenhuijzen', 'Affiliation': ''}, {'ForeName': 'Misha D P', 'Initials': 'MDP', 'LastName': 'Luyer', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004036']
2437,32541288,Cost of Elective Labor Induction Compared With Expectant Management in Nulliparous Women.,"OBJECTIVE


To compare the actual health-system cost of elective labor induction at 39 weeks of gestation with expectant management.
METHODS


This was an economic analysis of patients enrolled in the five Utah hospitals participating in a multicenter randomized trial of elective labor induction at 39 weeks of gestation compared with expectant management in low-risk nulliparous women. The entire trial enrolled more than 6,000 patients. For this subset, 1,201 had cost data available. The primary outcome was relative direct health care costs of maternal and neonatal care from a health system perspective. Secondary outcomes included the costs of each phase of maternal and neonatal care. Direct health system costs of maternal and neonatal care were measured using advanced costing analytics from the time of randomization at 38 weeks of gestation until exit from the study up to 8 weeks postpartum. Costs in each randomization arm were compared using generalized linear models and reported as the relative cost of induction compared with expectant management. With a fixed sample size, we had adequate power to detect a 7.3% or greater difference in overall costs.
RESULTS


The total cost of elective induction was no different than expectant management (mean difference +4.7%; 95% CI -2.1% to +12.0%; P=.18). Maternal outpatient antenatal care costs were 47.0% lower in the induction arm (95% CI -58.3% to -32.6%; P<.001). Maternal inpatient intrapartum and delivery care costs, conversely, were 16.9% higher among women undergoing labor induction (95% CI +5.5% to +29.5%; P=.003). Maternal inpatient postpartum care, maternal outpatient care after discharge, neonatal hospital care, and neonatal care after discharge did not differ between arms.
CONCLUSION


Total costs of elective labor induction and expectant management did not differ significantly. These results challenge the assumption that elective induction of labor leads to significant cost escalation.",2020,Maternal outpatient antenatal care costs were 47.0% lower in the induction arm (95% CI -58.3% to -32.6%; P<.001).,"['low-risk nulliparous women', 'patients enrolled in the five Utah hospitals participating', '6,000 patients', 'Nulliparous Women']","['Expectant Management', 'elective labor induction', 'expectant management']","['Maternal outpatient antenatal care costs', 'total cost of elective induction', 'Maternal inpatient postpartum care, maternal outpatient care after discharge, neonatal hospital care, and neonatal care after discharge', 'costs of each phase of maternal and neonatal care', 'overall costs', 'Cost of Elective Labor Induction', 'relative direct health care costs of maternal and neonatal care from a health system perspective', 'Maternal inpatient intrapartum and delivery care costs']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042124', 'cui_str': 'Utah'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum'}, {'cui': 'C1171257', 'cui_str': 'Delivery care'}]",,0.122938,Maternal outpatient antenatal care costs were 47.0% lower in the induction arm (95% CI -58.3% to -32.6%; P<.001).,"[{'ForeName': 'Brett D', 'Initials': 'BD', 'LastName': 'Einerson', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, and the Division of Epidemiology, Department of Internal Medicine, University of Utah Health, Intermountain Healthcare, and the IDEAS Center, VA Salt Lake City Healthcare System, Salt Lake City, Utah; George Washington University Biostatistics Center, Washington, DC; the Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Nelson', 'Affiliation': ''}, {'ForeName': 'Grecio', 'Initials': 'G', 'LastName': 'Sandoval', 'Affiliation': ''}, {'ForeName': 'M Sean', 'Initials': 'MS', 'LastName': 'Esplin', 'Affiliation': ''}, {'ForeName': 'D Ware', 'Initials': 'DW', 'LastName': 'Branch', 'Affiliation': ''}, {'ForeName': 'Torri D', 'Initials': 'TD', 'LastName': 'Metz', 'Affiliation': ''}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': ''}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Grobman', 'Affiliation': ''}, {'ForeName': 'Uma M', 'Initials': 'UM', 'LastName': 'Reddy', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Varner', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003930']
2438,32541299,Design of a Randomized Clinical Trial of Perioperative Vaginal Estrogen Versus Placebo With Transvaginal Native Tissue Apical Prolapse Repair (Investigation to Minimize Prolapse Repair of the Vagina using Estrogen: IMPROVE).,"OBJECTIVES


To provide the rationale and design for a randomized, double-blind clinical trial of conjugated estrogen vaginal cream (applied for at least 5 weeks preoperatively and continued twice-weekly through 12 months postoperatively) compared with placebo in postmenopausal women with symptomatic pelvic organ prolapse undergoing a standardized transvaginal native tissue apical repair.
METHODS


Study population, randomization process, study cream intervention, masking of participants and evaluators, placebo cream manufacture, standardized surgical intervention, and collection of adverse events are described. The primary outcome of surgical success is a composite of objectively no prolapse beyond the hymen and the vaginal cuff descending no more than one third the vaginal length; subjectively, no sense of vaginal pressure or bulging; and no retreatment for prolapse at 12 months. Time-to-failure postoperatively will be compared in the 2 groups with continued surveillance to 36 months. Secondary outcomes assessed at baseline, preoperatively (ie, after at least 5 weeks of study cream), and postoperatively at 6 month intervals include validated condition-specific and general quality-of-life metrics, overall impression of improvement, sexual function, vaginal atrophy symptoms, and body image. Challenges unique to this study include design and manufacture of placebo and defining and measuring study drug adherence.
RESULTS


Recruitment of 204 women is complete with 197 randomized. There have been 174 surgeries completed with 15 more pending; 111 have completed their 12 month postoperative visit.
CONCLUSIONS


This trial will contribute evidence-based information regarding the effect of perioperative vaginal estrogen as an adjunct therapy to standardized transvaginal native tissue prolapse surgical repair.",2020,"The primary outcome of surgical success is a composite of objectively no prolapse beyond the hymen and the vaginal cuff descending no more than one third the vaginal length; subjectively, no sense of vaginal pressure or bulging; and no retreatment for prolapse at 12 months.","['204 women is complete with 197 randomized', 'postmenopausal women with symptomatic pelvic organ prolapse undergoing a', 'standardized transvaginal native tissue prolapse surgical repair', '174 surgeries completed with 15 more pending; 111 have completed their 12 month postoperative visit']","['Perioperative Vaginal Estrogen Versus Placebo With Transvaginal Native Tissue Apical Prolapse Repair', 'perioperative vaginal estrogen', 'conjugated estrogen vaginal cream', 'standardized transvaginal native tissue apical repair', 'placebo cream manufacture, standardized surgical intervention', 'placebo']","['validated condition-specific and general quality-of-life metrics, overall impression of improvement, sexual function, vaginal atrophy symptoms, and body image', 'surgical success is a composite of objectively no prolapse beyond the hymen and the vaginal cuff descending no more than one third the vaginal length; subjectively, no sense of vaginal pressure or bulging; and no retreatment for prolapse']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580703', 'cui_str': 'Postoperative visit'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0856413', 'cui_str': 'Prolapse repair'}, {'cui': 'C0014938', 'cui_str': 'Estrogens, Conjugated (USP)'}, {'cui': 'C0042238', 'cui_str': 'Vaginal cream'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0241616', 'cui_str': 'Atrophy of vagina'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C1550321', 'cui_str': 'Vaginal cuff'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}]",204.0,0.688158,"The primary outcome of surgical success is a composite of objectively no prolapse beyond the hymen and the vaginal cuff descending no more than one third the vaginal length; subjectively, no sense of vaginal pressure or bulging; and no retreatment for prolapse at 12 months.","[{'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Rahn', 'Affiliation': 'From the Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Holly E', 'Initials': 'HE', 'LastName': 'Richter', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Alabama, Birmingham, AL.'}, {'ForeName': 'Vivian W', 'Initials': 'VW', 'LastName': 'Sung', 'Affiliation': 'Department of Obstetrics and Gynecology, Alpert Medical School of Brown University/Women and Infants Hospital of Rhode Island, Providence, RI.'}, {'ForeName': 'Wilma I', 'Initials': 'WI', 'LastName': 'Larsen', 'Affiliation': 'Department of Obstetrics and Gynecology, Baylor Scott and White Memorial Hospital, Temple TX.'}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'Hynan', 'Affiliation': 'Departments of Population and Data Sciences and Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX.'}]",Female pelvic medicine & reconstructive surgery,['10.1097/SPV.0000000000000899']
2439,32541300,Therapeutic Suggestion in Postoperative Pain Control: A Randomized Controlled Trial.,"OBJECTIVES


There is conflicting research on the effect of therapeutic suggestion in the perioperative period. This study systematically compared subjective and objective measures of postoperative pain, nausea and vomiting, urinary and bowel function, and global perception of symptomatic improvement between participants receiving perioperative therapeutic suggestion versus routine perioperative care during minimally invasive pelvic reconstructive surgery.
METHODS


This was a single-blinded, randomized controlled trial of participants undergoing vaginal hysterectomy with minimally invasive sacrocolpopexy and concomitant prolapse repairs. The intervention group received perioperative therapeutic suggestion, whereas the control group did not. Primary outcomes included postoperative pain scores and analgesic use. Secondary outcomes included a postoperative nausea and vomiting scale, the Pelvic Floor Distress Inventory Questionnaire-Short Form 20, the Patient Global Impression of Improvement scale, and time to return of bowel and bladder function.
RESULTS


Sixteen participants were randomized to each group. Final analysis included 15 intervention and 14 control participants. Overall measures of postoperative pain and analgesic use were low across all participants without a significant difference between intervention and control groups (opioid: 52.5; interquartile range [IQR], 25.5-58.9 vs 66 IQR, 7.3-125.8; morphine milligram equivalents; P = 0.64; acetaminophen: 2225 mg; IQR, 500-2600 mg vs 2800 mg; IQR, 650-4775 mg; P = 0.38). There were no statistically significant differences in secondary outcomes of urinary symptoms, bowel function, and subjective improvement of prolapse symptoms.
CONCLUSIONS


No differences in postoperative pain, analgesic use, return of bowel and bladder function, or pelvic organ prolapse symptoms were noted in participants receiving perioperative therapeutic suggestion versus routine perioperative care.",2020,"There were no statistically significant differences in secondary outcomes of urinary symptoms, bowel function, and subjective improvement of prolapse symptoms.
","['participants undergoing vaginal hysterectomy with minimally invasive sacrocolpopexy and concomitant prolapse repairs', 'Sixteen participants', 'Postoperative Pain Control', 'participants receiving']","['perioperative therapeutic suggestion versus routine perioperative care during minimally invasive pelvic reconstructive surgery', 'perioperative therapeutic suggestion', 'acetaminophen']","['postoperative pain and analgesic use', 'postoperative pain, nausea and vomiting, urinary and bowel function, and global perception of symptomatic improvement', 'postoperative nausea and vomiting scale, the Pelvic Floor Distress Inventory Questionnaire-Short Form 20, the Patient Global Impression of Improvement scale, and time to return of bowel and bladder function', 'urinary symptoms, bowel function, and subjective improvement of prolapse symptoms', 'postoperative pain scores and analgesic use', 'postoperative pain, analgesic use, return of bowel and bladder function, or pelvic organ prolapse symptoms']","[{'cui': 'C0020700', 'cui_str': 'Vaginal hysterectomy'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0554325', 'cui_str': 'Sacrocolpopexy'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0856413', 'cui_str': 'Prolapse repair'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038659', 'cui_str': 'Suggestion'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0150706', 'cui_str': 'Perioperative care'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0524865', 'cui_str': 'Reconstruction - action'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C4706333', 'cui_str': 'Patient Global Impression of Improvement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0232840', 'cui_str': 'Bladder function'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}]",16.0,0.16171,"There were no statistically significant differences in secondary outcomes of urinary symptoms, bowel function, and subjective improvement of prolapse symptoms.
","[{'ForeName': 'Nemi M', 'Initials': 'NM', 'LastName': 'Shah', 'Affiliation': 'From the Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Leslie A', 'Initials': 'LA', 'LastName': 'Andriani', 'Affiliation': 'Department of Obstetrics and Gynecology, New York University Langone Medical Center, New York, NY.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Mofidi', 'Affiliation': 'Department of Sports Medicine, Kaiser Permanente Los Angeles Medical Center, Los Angeles, CA.'}, {'ForeName': 'Caitlin F', 'Initials': 'CF', 'LastName': 'Ingraham', 'Affiliation': 'Department of Obstetrics and Gynecology, Christiana Care Health System, Wilmington, DE.'}, {'ForeName': 'Eshetu A', 'Initials': 'EA', 'LastName': 'Tefera', 'Affiliation': 'Department of Biostatistics and Bioinformatics at MedStar Health Research Institute, Hyattsville, MD.'}, {'ForeName': 'Cheryl B', 'Initials': 'CB', 'LastName': 'Iglesia', 'Affiliation': 'Section of Female Pelvic Medicine and Reconstructive Surgery at MedStar Washington Hospital Center, Washington, DC.'}]",Female pelvic medicine & reconstructive surgery,['10.1097/SPV.0000000000000906']
2440,32541301,Vaginal Sacrospinous Ligament Fixation Using Tissue Anchoring System Versus a Traditional Technique for Women With Apical Vaginal Prolapse: A Randomized Controlled Trial.,"OBJECTIVE


The aim of the study was to compare the efficacy and safety of the tissue anchoring system (TAS) kit versus the traditional technique for sacrospinous ligament fixation (SSLF) to treat apical vaginal wall prolapse.
METHODS


A prospective randomized controlled multicenter study of noninferiority involving women with apical prolapse (C-point≥+1). Primary outcome is surgical success as C-point≤-4 at the 1-year follow-up. Secondary outcomes are success according to the composite criteria as C-point≤-4, Ba-point ≤0, and Bp-point ≤0; POP-Q measures of the vaginal compartments; intraoperative findings, complications; reoperation rate; hospital stay; and quality of life and sexual functioning (PISQ-12). It was estimated that 50 individuals per group would yield an 80% power for a noninferiority margin of 15%.
RESULTS


Ninety-nine women were randomized: TAS (n = 55) and traditional SSLF (n = 44). The groups' preoperative data were similar. Drop-out rate was 11% for 12-month follow-up. Success rates were 90% for TAS and 80% for traditional SSLF (P = 0.0006; absolute difference, 9.8%; 90% confidence interval, -5.2 to 24.8) with the sensivity analyses per-protocol considering only the subjects that completed the 12-month follow-up and 80% versus 73%, respectively (P = 0.0048; absolute difference, 7.3%; 90% confidence interval, -9.6 to 24.2) by sensivity analyses considering the total number of participants randomized and treated with drop-out cases as failure. We detected shorter intraoperative time to dissect and reach the SSL, shorter length of hospitalization, lower rates of urinary tract infection, and lower pain scores in the first 30 days postoperative in the TAS compared with the traditional SSLF groups (P < 0.05). There was an improvement in women's quality of life that did not differ between groups.
CONCLUSIONS


The modified technique of SSLF using the TAS kit is noninferior to the traditional technique for the treatment of apical compartment in 12-month follow-up.",2020,"Success rates were 90% for TAS and 80% for traditional SSLF (P = 0.0006; absolute difference, 9.8%;","['women with apical prolapse (C-point≥+1', 'Ninety-nine women', 'Women With Apical Vaginal Prolapse']","['traditional SSLF', 'TAS', 'tissue anchoring system (TAS) kit versus the traditional technique for sacrospinous ligament fixation (SSLF', 'Vaginal Sacrospinous Ligament Fixation Using Tissue Anchoring System Versus a Traditional Technique']","[""women's quality of life"", 'surgical success as C-point≤-4 at the 1-year follow-up', 'intraoperative time to dissect and reach the SSL, shorter length of hospitalization, lower rates of urinary tract infection, and lower pain scores', 'success according to the composite criteria as C-point≤-4, Ba-point ≤0, and Bp-point ≤0; POP-Q measures of the vaginal compartments; intraoperative findings, complications; reoperation rate; hospital stay; and quality of life and sexual functioning (PISQ-12', 'efficacy and safety', 'Success rates']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C3828813', 'cui_str': '99'}, {'cui': 'C0205990', 'cui_str': 'Vaginal wall prolapse'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0225049', 'cui_str': 'Structure of sacrospinous ligament'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205239', 'cui_str': 'Dissecting'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",99.0,0.138899,"Success rates were 90% for TAS and 80% for traditional SSLF (P = 0.0006; absolute difference, 9.8%;","[{'ForeName': 'Rodrigo Aquino', 'Initials': 'RA', 'LastName': 'Castro', 'Affiliation': 'From the EPM, UNIFESP.'}, {'ForeName': 'Maria Augusta Tezelli', 'Initials': 'MAT', 'LastName': 'Bortolini', 'Affiliation': 'From the EPM, UNIFESP.'}, {'ForeName': 'Ana Lívia Garcia', 'Initials': 'ALG', 'LastName': 'Pascom', 'Affiliation': 'From the EPM, UNIFESP.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Ledesma', 'Affiliation': 'Clínica Sucre, Córdoba.'}, {'ForeName': 'Juan José Luis', 'Initials': 'JJL', 'LastName': 'Sardi', 'Affiliation': 'Hospital Británico, Buenos Aires, Argentina.'}, {'ForeName': 'Marilene Vale de Castro', 'Initials': 'MVC', 'LastName': 'Monteiro', 'Affiliation': 'Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil.'}, {'ForeName': 'Sebastián Perez', 'Initials': 'SP', 'LastName': 'Junqueira', 'Affiliation': 'GEDREP, Buenos Aires, Argentina.'}, {'ForeName': 'Edna Cortes', 'Initials': 'EC', 'LastName': 'Fuentes', 'Affiliation': 'Hospital de Ginecología y Obstetricia, Toluca, Mexico.'}]",Female pelvic medicine & reconstructive surgery,['10.1097/SPV.0000000000000897']
2441,32541365,Multicenter visual outcomes comparison of 2 trifocal presbyopia-correcting intraocular lenses: 6-month postoperative results.,"PURPOS: e: To clinically evaluate visual performance of the AcrySof IQ PanOptix TFNT00 and AT LISA tri 839MP intraocular lenses (IOLs) in binocular visual acuity (VA) and to characterize low contrast visual performance at 6 months post-implantation.
SETTING


Multicenter, 15 sites.
DESIGN


Prospective, parallel-group, randomized, double-masked, postmarketing clinical study.
METHODS


Binocular uncorrected distance (UDVA, 4 m), intermediate (UIVA, 60 cm), near (UNVA, 40 cm) VAs, and binocular defocus curves, were evaluated under photopic lighting conditions. Photopic and mesopic contrast sensitivity with and without glare was assessed.
RESULTS


The study included182 subjects (62% female; mean age, 66±9.4 years) who were implanted bilaterally with the TFNT00 IOL (n=93) or 839MP IOL (n=89), and binocular VA was evaluated 4 to 6 months (120-180 days) post-implantation. The TFNT00 group showed superior visual outcomes compared with the 839MP group in binocular UIVA (P=0.001), UNVA (P=0.003) and noninferior outcomes in UDVA (95% CI, -0.023 to 0.041; upper limit <0.1 logMAR [logarithm of the minimum angle of resolution] [margin of noninferiority]). Mean defocus curve from 0.00 to -3.00 diopter ranged from 0.1 to 0.0 logMAR for both lenses; better mean VA values (logMAR) were observed in the TFNT00 group between -1.50 to -2.50 D compared with 839MP. Contrast sensitivity values were similar between the 2 groups in all conditions.
CONCLUSION


The results of this study showed improved visual performance at near and intermediate distances with the TFNT00 IOL compared with the 839MP IOL.",2020,"The TFNT00 group showed superior visual outcomes compared with the 839MP group in binocular UIVA (P=0.001), UNVA (P=0.003) and noninferior outcomes in UDVA (95% CI, -0.023 to 0.041; upper limit <0.1 logMAR [logarithm of the minimum angle of resolution] [margin of noninferiority]).","['study included182 subjects (62% female; mean age, 66±9.4 years) who were implanted bilaterally with the TFNT00 IOL (n=93) or 839MP IOL (n=89), and binocular VA was evaluated 4 to 6 months (120-180 days) post-implantation', 'Multicenter, 15 sites']","['PURPOS', 'AcrySof IQ PanOptix TFNT00 and AT LISA tri 839MP intraocular lenses (IOLs', '2 trifocal presbyopia-correcting intraocular lenses']","['UNVA', 'mean VA values (logMAR', 'visual performance', 'superior visual outcomes', 'Contrast sensitivity values', 'binocular UIVA', 'Binocular uncorrected distance (UDVA, 4 m), intermediate (UIVA, 60 cm), near (UNVA, 40 cm) VAs, and binocular defocus curves', 'Photopic and mesopic contrast sensitivity with and without glare']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C1275646', 'cui_str': 'Trifocal glasses'}, {'cui': 'C0033075', 'cui_str': 'Presbyopia'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0278215', 'cui_str': 'Glare'}]",,0.0929871,"The TFNT00 group showed superior visual outcomes compared with the 839MP group in binocular UIVA (P=0.001), UNVA (P=0.003) and noninferior outcomes in UDVA (95% CI, -0.023 to 0.041; upper limit <0.1 logMAR [logarithm of the minimum angle of resolution] [margin of noninferiority]).","[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Lapid-Gortzak', 'Affiliation': 'From the Department of Ophthalmology, Amsterdam University Medical Centers (Lapid-Gortzak), Amsterdam, Netherlands; Vision Eye Institute (Bhatt), Melbourne, Victoria, Australia; Instituto Nacional de Investigacion en Oftalmologia (Sanchez), Medellin-Antioquia, Colombia; Valles Oftalmologia Recerca (Guarro), Barcelona, Spain; Hospital Oftalmologico de Brasilia (Hida), Brasilia, Brazil; Personal Eyes (Bala), Sydney, New South Wales, Australia; Eye Clinic (Nosé), São Paulo, Brazil; Fundacion Oftalmologica Nacional, Universidad del Rosario (Alvira), Bogota, Colombia; Alcon Vision LLC (Martinez), Fort Worth, Texas, USA.'}, {'ForeName': 'Uday', 'Initials': 'U', 'LastName': 'Bhatt', 'Affiliation': ''}, {'ForeName': 'Juan Gonzalo', 'Initials': 'JG', 'LastName': 'Sanchez', 'Affiliation': ''}, {'ForeName': 'Mercè', 'Initials': 'M', 'LastName': 'Guarro', 'Affiliation': ''}, {'ForeName': 'Wilson Takashi', 'Initials': 'WT', 'LastName': 'Hida', 'Affiliation': ''}, {'ForeName': 'Chandra', 'Initials': 'C', 'LastName': 'Bala', 'Affiliation': ''}, {'ForeName': 'Ricardo Menon', 'Initials': 'RM', 'LastName': 'Nosé', 'Affiliation': ''}, {'ForeName': 'Francisco Jose', 'Initials': 'FJ', 'LastName': 'Rodriguez Alvira', 'Affiliation': ''}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Martinez', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000274']
2442,32541370,Can Treatment with Citicoline Eyedrops Reduce Progression in Glaucoma? The Results of a Randomized Placebo-controlled Clinical Trial.,"PRECIS


Citicoline eyedrops in patients with progressing glaucoma.
PURPOSE


To test whether the additional therapy with citicoline eyedrops to intraocular pressure (IOP) -lowering treatment could slow glaucoma progression in patients with worsening of damage and IOP 18 mmHg or less.
DESIGN


Randomized, double-masked, placebo-controlled, multicenter 3-year study.
OUTCOMES


Difference in visual field (mean deviation, MD, of 24-2; MD of 10-2) rates of progression; difference in retinal nerve fiber layer (RNFL) thickness change between the 2 study groups at 3 years.
METHODS


Patients with mild to moderate open-angle glaucoma (OAG) showing damage progression of at least -0.5▒dB/y in the 2 years before enrolment despite IOP ≤18▒mmHg, were randomized to receive citicoline eyedrops or placebo 3 times daily for 3 years. Patients were followed every 3 months and underwent visual field examination with 24-2 and 10-2 strategies and RNFL assessment. ANOVA and linear models were used to test the differences between groups.
RESULTS


Eighty patients were randomized in the trial. Mean three-year rates of progression were -1.03 (2.14) dB in citicoline group and -1.92 (2.23) dB in the placebo group (P=0.07) for 24-2 MD and -0.41 (3.45) dB in citicoline group and -2.22 (3.63) dB in the placebo group (P=0.02) for 10-2 MD. On average patients receiving citicoline eyedrops lost 1.86 microns of RNFL in 3 years, versus 2.99 microns in the placebo group (P=0.02).
CONCLUSIONS


Additional treatment with citicoline eyedrops to IOP-lowering treatment might reduce disease progression in patients with progressing glaucoma despite IOP ≤18▒mmHg.",2020,Mean three-year rates of progression were -1.03 (2.14) dB in citicoline group and -1.92,"['y in the 2 years before enrolment despite IOP ≤18▒mmHg', 'Eighty patients', 'patients with progressing glaucoma', 'Patients with mild to moderate open-angle glaucoma (OAG) showing damage progression of at least -0.5▒', 'patients with progressing glaucoma despite IOP ≤18▒mmHg', 'patients with worsening of damage and IOP 18 mmHg or less']","['Placebo', 'citicoline eyedrops or placebo', 'citicoline eyedrops', 'Citicoline Eyedrops', 'PRECIS\n\n\nCiticoline eyedrops', 'citicoline eyedrops to intraocular pressure (IOP) -lowering treatment', 'placebo']","['disease progression', 'visual field (mean deviation, MD, of 24-2; MD of 10-2) rates of progression; difference in retinal nerve fiber layer (RNFL) thickness change']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010725', 'cui_str': 'Citicoline'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C1828170', 'cui_str': 'Mean deviation'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1720466', 'cui_str': 'Nerve fiber layer'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",80.0,0.500531,Mean three-year rates of progression were -1.03 (2.14) dB in citicoline group and -1.92,"[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Rossetti', 'Affiliation': 'Clinica Oculistica, ASST Santi Paolo e Carlo, Università di Milano, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Iester', 'Affiliation': 'Clinica Oculistica, DiNOGMI, University of Genoa, Genoa, Italy, IRCCS Ospedale Policlinico San Martino, Genova, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Tranchina', 'Affiliation': 'Clinica Oculistica, ASST Santi Paolo e Carlo, Università di Milano, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ottobelli', 'Affiliation': 'Clinica Oculistica, ASST Santi Paolo e Carlo, Università di Milano, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Coco', 'Affiliation': 'Dipartimento di Scienze Cliniche e Medicina Traslazionale, Università di Tor Vergata, Roma, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Calcatelli', 'Affiliation': 'Dipartimento di Scienze Cliniche e Medicina Traslazionale, Università di Tor Vergata, Roma, Italy.'}, {'ForeName': 'Chia', 'Initials': 'C', 'LastName': 'Ancona', 'Affiliation': 'Clinica Oculistica, DiNOGMI, University of Genoa, Genoa, Italy, IRCCS Ospedale Policlinico San Martino, Genova, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Cirafici', 'Affiliation': 'Clinica Oculistica, DiNOGMI, University of Genoa, Genoa, Italy, IRCCS Ospedale Policlinico San Martino, Genova, Italy.'}, {'ForeName': 'Gianluca L', 'Initials': 'GL', 'LastName': 'Manni', 'Affiliation': 'Dipartimento di Scienze Cliniche e Medicina Traslazionale, Università di Tor Vergata, Roma, Italy.'}]",Journal of glaucoma,['10.1097/IJG.0000000000001565']
2443,32541480,Systematic training program for nursing home staff based on the concept of combination of medicine and care.,"It is important to improve the training for nursing home staff in order to achieve better quality of life for the elderly.This study aimed to develop a systematic training program for nursing home staff based on the concept of combination of medicine and care.Thirty-four nursing staff from 2 representative nursing homes in Qiqihar City were selected as study subjects and divided into experimental and control groups. The subjects in both groups received routine training following ""National Occupational Standards of Elderly Nursing Staff"". In addition, the subjects in experimental groups received systematic training at three levels based on the concept of combination of medicine and care for 4 months.After the training, the competence scores of nursing staff in experimental group increased significantly compared to control group, the living quality of the elderly in nursing homes cared by nursing staff in experimental group was significantly improved, and the satisfaction of the elderly to nursing staff in experimental group improved significantly, compared to control group (P < .05).We develop systematic training program for nursing home staff based on the concept of combination of medicine and care, which can improve nursing care for the elderly in nursing home.",2020,"After the training, the competence scores of nursing staff in experimental group increased significantly compared to control group, the living quality of the elderly in nursing homes cared by nursing staff in experimental group was significantly improved, and the satisfaction of the elderly to nursing staff in experimental group improved significantly, compared to control group (P < .05).We develop systematic training program for nursing home staff based on the concept of combination of medicine and care, which can improve nursing care for the elderly in nursing home.",['Thirty-four nursing staff from 2 representative nursing homes in Qiqihar City'],"['routine training', 'systematic training']","['satisfaction of the elderly to nursing staff', 'competence scores of nursing staff', 'living quality']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0028698', 'cui_str': 'Nursing Staffs'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0028698', 'cui_str': 'Nursing Staffs'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",,0.00933714,"After the training, the competence scores of nursing staff in experimental group increased significantly compared to control group, the living quality of the elderly in nursing homes cared by nursing staff in experimental group was significantly improved, and the satisfaction of the elderly to nursing staff in experimental group improved significantly, compared to control group (P < .05).We develop systematic training program for nursing home staff based on the concept of combination of medicine and care, which can improve nursing care for the elderly in nursing home.","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Nursing.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'The First Hospital of Qiqihar, Heilongjiang, PR China.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Nursing.'}, {'ForeName': 'Chunhua', 'Initials': 'C', 'LastName': 'Qian', 'Affiliation': 'Department of Nursing.'}, {'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Sun', 'Affiliation': 'Department of Nursing.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Nursing.'}]",Medicine,['10.1097/MD.0000000000020559']
2444,32541498,Intravenous versus topical tranexamic acid in lumbar interbody fusion: A protocol of randomized controlled trial.,"BACKGROUND


Questions still remain about the safest and most effective route of administration for tranexamic acid (TXA) in lumbar interbody fusion. As such, the goal of this randomized clinical trial was to assess the efficacy and safety of topical TXA compared with intravenous TXA in lumbar interbody fusion.
METHODS


This was a prospectively randomized trial that investigated the effectiveness and safety of the intravenous and topical administrations of TXA with regard to lumbar interbody fusion. Approval from Clinical Studies Ethical Committee in our hospital was obtained. The patients were randomized to 1 of 2 treatment options:Patients, surgeons, anesthesiologists, nurses, and research assistants collecting data were blinded to group allocation. The primary outcome measures were perioperative calculated blood loss, total drain output at 24 hours, and perioperative blood transfusion rate. Secondary outcomes included an analysis of complications, namely symptomatic venous thromboembolism, cerebrovascular accident, and arterio-occlusive events. Data were analyzed using the statistical software package SPSS version 25.0 (Chicago, IL).
RESULTS


There are several limitations to this study. We did not include a group of patients who did not receive TXA. Another potential limitation is that the study population contains heterogeneity such as varying patient diagnosis and surgical technique/approach. Despite these limitations, the validity of our results should be maintained, as the same methodology was applied to both treatment arms.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5564).",2020,"BACKGROUND


Questions still remain about the safest and most effective route of administration for tranexamic acid (TXA) in lumbar interbody fusion.",['lumbar interbody fusion'],"['tranexamic acid (TXA', 'TXA', 'topical TXA', 'intravenous TXA', 'topical tranexamic acid']","['efficacy and safety', 'perioperative calculated blood loss, total drain output at 24\u200ahours, and perioperative blood transfusion rate', 'analysis of complications, namely symptomatic venous thromboembolism, cerebrovascular accident, and arterio-occlusive events', 'effectiveness and safety']","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.278037,"BACKGROUND


Questions still remain about the safest and most effective route of administration for tranexamic acid (TXA) in lumbar interbody fusion.","[{'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Song', 'Affiliation': ""Department of Orthopedics, People's Hospital of Nanchuan District, Chongqing, China.""}, {'ForeName': 'Zhouhai', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020619']
2445,32541504,The efficacy of ketamine in total knee arthroplasty: a randomized controlled trial protocol.,"BACKGROUND


Appropriate pain management is essential to improve the postoperative recovery after total knee arthroplasty (TKA). There is a paucity of literature on ketamine for TKA procedures. The aim of this study was to evaluate the analgesic efficacy of ketamine in patients undergoing primary TKA.
METHODS


This study was designed as a prospective, double blind, single center, randomized controlled trial. The participants were randomly assigned to either the ketamine or placebo groups, using a set of random numbers for the allocation sequence. All patients underwent TKA without patella resurfacing under spinal anesthesia. Preoperative workup, surgical technique, and postoperative management were standardized for all the patients. The primary outcome of this noninferiority study is opioid consumption within the first 24 hours following surgery, pain scores, distance ambulated, patient satisfaction, length of hospital stay, and complications.
RESULTS


The results of this study were expected to provide useful information on the effectiveness and safety of ketamine for immediate postoperative analgesia after TKA surgery.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5575).",2020,"The results of this study were expected to provide useful information on the effectiveness and safety of ketamine for immediate postoperative analgesia after TKA surgery.
","['total knee arthroplasty', 'total knee arthroplasty (TKA', 'patients undergoing primary TKA']","['TKA without patella resurfacing under spinal anesthesia', 'ketamine or placebo', 'ketamine']","['analgesic efficacy', 'opioid consumption within the first 24\u200ahours following surgery, pain scores, distance ambulated, patient satisfaction, length of hospital stay, and complications']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.488923,"The results of this study were expected to provide useful information on the effectiveness and safety of ketamine for immediate postoperative analgesia after TKA surgery.
","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopedics, Aerospace Center Hospital, Beijing.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': 'Department of Orthopedics, Ningxia Armed Police Corps Hospital, Ningxia Hui Autonomous Region.'}, {'ForeName': 'Shu-Ming', 'Initials': 'SM', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Aerospace Center Hospital, Beijing.'}, {'ForeName': 'Xiao-Lin', 'Initials': 'XL', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Ningxia Armed Police Corps Hospital, Ningxia Hui Autonomous Region.'}, {'ForeName': 'Zhan-Min', 'Initials': 'ZM', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Aerospace Center Hospital, Beijing, China.'}]",Medicine,['10.1097/MD.0000000000020645']
2446,32541510,A randomized controlled study for Yuanhu Zhitong dropping pills in the treatment of knee osteoarthritis.,"BACKGROUND


Knee osteoarthritis (KOA) is a common chronic disorder of knee and the leading cause of pain in the elderly with an overall prevalence of 50% in people over 60 years of age. This disease is an important factor affecting the quality of life of middle-aged and elderly people, and its main symptom is knee joint pain. Due to the pain, the knee joint activity function is limited, bringing great pain to patients, affecting their quality of life, effective prevention, and treatment of KOA is a modern medical problem.
METHODS


The 60 patients who met the inclusion criteria were randomly divided into the treatment group and the control group. In this study, single center, randomized control and equivalent clinical trial were used for treatment. The treatment group received Yuanhu Zhitong dropping pills within 4 weeks, and the control group received diclofenac sodium sustained-release capsule treatment within 4 weeks. The main measures were visual analogue scale (VAS), WOMAC osteoarthritis index score and gastrointestinal symptoms rating scale (GSRS).Secondary measures included biochemical markers and adverse reactions during treatment.
RESULT


The results of this trial will be published on the website of China Clinical Trial Registration Center (http://www.chictr.org.cn/searchprojen.aspx) and in peer-reviewed journals or academic conferences.
CONCLUSIONS


This study is to assess the efficacy and safety of Yuanhu Zhitong dropping pills for knee osteoarthritis (KOA).
REGISTRATION


PROSPERO (registration number ChiCTR1900024712).",2020,"The main measures were visual analogue scale (VAS), WOMAC osteoarthritis index score and gastrointestinal symptoms rating scale (GSRS).Secondary measures included biochemical markers and adverse reactions during treatment.
","['knee osteoarthritis', 'elderly with an overall prevalence of 50% in people over 60 years of age', '60 patients who met the inclusion criteria', 'knee osteoarthritis (KOA']","['Yuanhu Zhitong dropping pills', 'diclofenac sodium sustained-release capsule treatment']","['visual analogue scale (VAS), WOMAC osteoarthritis index score and gastrointestinal symptoms rating scale (GSRS).Secondary measures included biochemical markers and adverse reactions', 'efficacy and safety']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C3885247', 'cui_str': 'yuanhu zhitong'}, {'cui': 'C0440421', 'cui_str': 'Droppings'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0700583', 'cui_str': 'Diclofenac sodium'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",60.0,0.0717213,"The main measures were visual analogue scale (VAS), WOMAC osteoarthritis index score and gastrointestinal symptoms rating scale (GSRS).Secondary measures included biochemical markers and adverse reactions during treatment.
","[{'ForeName': 'Yubiao', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'Gansu Provincial Hospital of TCM.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Gansu Provincial Hospital of TCM.'}, {'ForeName': 'Honggang', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': 'Gansu University of Chinese medicine.'}, {'ForeName': 'Xuewen', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': 'Gansu University of Chinese medicine.'}, {'ForeName': 'Jianguo', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Gansu Provincial Hospital of TCM.'}, {'ForeName': 'Yanlong', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Gansu University of Chinese medicine.'}, {'ForeName': 'Xingwen', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'Department of Orthopaedics, Affiliated Hospital of Northwest Minzu University.'}]",Medicine,['10.1097/MD.0000000000020666']
2447,32541618,A Comparison of Bilateral vs. Unilateral-Biased Strength and Power Training Interventions on Measures of Physical Performance in Elite Youth Soccer Players.,"Stern, D, Gonzalo-Skok, O, Loturco, I, Turner, A, and Bishop, C. A comparison of bilateral vs. unilateral-biased strength and power training interventions on measures of physical performance in elite youth soccer players. J Strength Cond Res XX(X): 000-000, 2020-The aim of the present study was to compare the effects of bilateral and unilateral-biased strength and power training programs on measures of physical performance in male youth soccer players. Twenty-three elite youth players (age: 17.6 ± 1.2 years) were randomly assigned to either a unilateral (n = 11) or a bilateral (n = 12) group, who completed a strength and power intervention, twice per week for 6 weeks. The unilateral group completed rear foot elevated split squats (RFESS), single-leg countermovement jumps (SLCMJs), single-leg drop jumps (SLDJs), and single-leg broad jumps (SLBJs). The bilateral group intervention performed back squats, CMJs, drop jumps (DJ), and broad jumps (BJ). A 2 × 2 repeated measures analysis of variance showed no between-group differences. However, within-group differences were evident. The bilateral training group showed significant (p < 0.05) improvements in back squat strength (d = 1.27; %Δ = 26.01), RFESS strength (d = 1.64; %Δ = 23.34), BJ (d = 0.76; %Δ = 5.12), 10-m (d = -1.17; %Δ = 4.29), and 30-m (d = -0.88; %Δ = 2.10) performance. The unilateral group showed significant (p < 0.05) improvements in RFESS strength (d = 1.40; %Δ = 33.29), SLCMJ on the left leg (d = 0.76; %Δ = 9.84), SLBJ on the left leg (d = 0.97; %Δ = 6.50), 10 m (d = -1.50; %Δ = 5.20), and 505 on the right leg (d = -0.78; %Δ = 2.80). Standardized mean differences showed that bilateral training favored improvements in back squat strength and unilateral training favored improvements in RFESS strength, SLDJ on the right leg and 505 on the right leg. These results show that although both training interventions demonstrated trivial-to-large improvements in physical performance, the notion of training specificity was evident with unilateral training showing greater improvements in unilateral test measures.",2020,"Standardized mean differences showed that bilateral training favored improvements in back squat strength and unilateral training favored improvements in RFESS strength, SLDJ on the right leg and 505 on the right leg.","['Twenty-three elite youth players (age: 17.6 ± 1.2 years', 'male youth soccer players', 'elite youth soccer players', 'Elite Youth Soccer Players']","['SLCMJ', 'J Strength Cond Res XX(X', 'unilateral group completed rear foot elevated split squats (RFESS), single-leg countermovement jumps (SLCMJs), single-leg drop jumps (SLDJs), and single-leg broad jumps (SLBJs', 'bilateral group intervention performed back squats, CMJs, drop jumps (DJ), and broad jumps (BJ', 'Bilateral vs. Unilateral-Biased Strength and Power Training Interventions', 'bilateral and unilateral-biased strength and power training programs']","['left leg', 'SLBJ on the left leg', 'RFESS strength', 'back squat strength and unilateral training favored improvements in RFESS strength, SLDJ on the right leg and 505 on the right leg', 'RFESS strength ', 'back squat strength', 'physical performance', 'unilateral test measures', 'Physical Performance']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}]","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0230443', 'cui_str': 'Structure of left lower leg'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0230415', 'cui_str': 'Structure of right lower limb'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0151728,"Standardized mean differences showed that bilateral training favored improvements in back squat strength and unilateral training favored improvements in RFESS strength, SLDJ on the right leg and 505 on the right leg.","[{'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Stern', 'Affiliation': 'Millwall Football Club Academy, Calmont Road, Bromley, United Kingdom.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Gonzalo-Skok', 'Affiliation': 'Return to Play Department, Sevilla Football Club, Seville, Spain.'}, {'ForeName': 'Irineu', 'Initials': 'I', 'LastName': 'Loturco', 'Affiliation': 'Department of Sport Science and Research, Nucleus of High Performance in Sport, Sao Paulo, Brazil.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Turner', 'Affiliation': 'Faculty of Science and Technology, London Sports Institute, Middlesex University, London, United Kingdom.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bishop', 'Affiliation': 'Faculty of Science and Technology, London Sports Institute, Middlesex University, London, United Kingdom.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003659']
2448,32541620,Cost-Effectiveness and Return-on-Investment of the Dynamic Work Intervention Compared With Usual Practice to Reduce Sedentary Behavior.,"OBJECTIVE


To assess the cost-effectiveness and return-on-investment (ROI) of the Dynamic Work (DW) Intervention, a worksite intervention aimed at reducing sitting time among office workers.
METHODS


In total, 244 workers were randomized to the intervention or control group. Overall sitting time, standing time, step counts, quality-adjusted life years (QALYs), and costs were measured over 12 months. The cost-effectiveness analysis was performed from the societal perspective and the ROI analysis from the employers' perspective.
RESULTS


No significant differences in effects and societal costs were observed between groups. Presenteeism costs were significantly lower in the intervention group. The probability of the intervention being cost-effective was 0.90 at a willingness-to-pay of 20,000&OV0556;/QALY. The probability of financial savings was 0.86.
CONCLUSION


The intervention may be considered cost-effective from the societal perspective depending on the willingness-to-pay. From the employer perspective, the intervention seems cost-beneficial.",2020,Presenteeism costs were significantly lower in the intervention group.,"['office workers', '244 workers']","['Dynamic Work Intervention', 'Dynamic Work (DW) Intervention']","['Presenteeism costs', 'cost-effectiveness and return-on-investment (ROI', 'Overall sitting time, standing time, step counts, quality-adjusted life years (QALYs), and costs', 'Cost-Effectiveness and Return-on-Investment', 'effects and societal costs', 'probability of financial savings']","[{'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C4517660', 'cui_str': '244'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4042785', 'cui_str': 'Sickness Presence'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0021953', 'cui_str': 'Investments'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0036245', 'cui_str': 'Savings'}]",244.0,0.0277514,Presenteeism costs were significantly lower in the intervention group.,"[{'ForeName': 'Ângela J', 'Initials': 'ÂJ', 'LastName': 'Ben', 'Affiliation': 'Department of Health Sciences, Faculty Science, Vrije Universiteit Amsterdam, de Boelelaan 1085, 1081 HV Amsterdam, The Netherlands.'}, {'ForeName': 'Judith G M', 'Initials': 'JGM', 'LastName': 'Jelsma', 'Affiliation': 'Department of Public and Occupational Health, Amsterdam Public Health research institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Van derBoechorststraat 7, 1081BT Amsterdam, The Netherlands.'}, {'ForeName': 'Lidewij R', 'Initials': 'LR', 'LastName': 'Renaud', 'Affiliation': 'Department of Public and Occupational Health, Amsterdam Public Health research institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Van derBoechorststraat 7, 1081BT Amsterdam, The Netherlands.'}, {'ForeName': 'Maaike A', 'Initials': 'MA', 'LastName': 'Huysmans', 'Affiliation': 'Department of Public and Occupational Health, Amsterdam Public Health research institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Van derBoechorststraat 7, 1081BT Amsterdam, The Netherlands.'}, {'ForeName': 'Femke', 'Initials': 'F', 'LastName': 'van Nassau', 'Affiliation': 'Department of Public and Occupational Health, Amsterdam Public Health research institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Van derBoechorststraat 7, 1081BT Amsterdam, The Netherlands.'}, {'ForeName': 'Allard J', 'Initials': 'AJ', 'LastName': 'van der Beek', 'Affiliation': 'Department of Public and Occupational Health, Amsterdam Public Health research institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Van derBoechorststraat 7, 1081BT Amsterdam, The Netherlands.'}, {'ForeName': 'Hidde P', 'Initials': 'HP', 'LastName': 'van der Ploeg', 'Affiliation': 'Department of Public and Occupational Health, Amsterdam Public Health research institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Van derBoechorststraat 7, 1081BT Amsterdam, The Netherlands.'}, {'ForeName': 'Johanna M', 'Initials': 'JM', 'LastName': 'van Dongen', 'Affiliation': 'Department of Health Sciences, Faculty Science, Vrije Universiteit Amsterdam, de Boelelaan 1085, 1081 HV Amsterdam, The Netherlands.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Bosmans', 'Affiliation': 'Department of Health Sciences, Faculty Science, Vrije Universiteit Amsterdam, de Boelelaan 1085, 1081 HV Amsterdam, The Netherlands.'}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000001930']
2449,32541643,"Effects of Valsartan on Restenosis in Patients with Arteriosclerosis Obliterans of the Lower Extremities Undergoing Interventional Therapy: A Prospective, Randomized, Single-Blind Trial.","BACKGROUND The aim of this study was to further clarify the effects of valsartan on restenosis in patients with arteriosclerosis obliterans of the lower extremities. MATERIAL AND METHODS Patients with arteriosclerosis obliterans of the lower extremities undergoing continuous stent implantation in the superficial femoral artery were enrolled and randomly divided into an ARB group and a control group. Patients in the ARB group received valsartan orally in a single-blind manner and were followed up for 6 months. An evaluation was performed based on the criteria for clinical efficacies designed by the Committee of Vascular Disease, Chinese Association of Integrative Medicine. The total clinical effective rate was calculated, and ankle brachial index (ABI) of the patients was assessed. The concentrations of interleukin-6 (IL-6) and high-sensitivity C-reactive protein (hs-CRP) were measured using enzyme-linked immunosorbent assay. The in-stent restenosis of patients was examined by angiography. RESULTS One patient in the control group died due to acute cerebral hemorrhage 4 months after enrollment, and 1 patient was lost to follow-up due to acute myocardial infarction during follow-up 5 months after enrollment. Age, sex, Fontaine stage, and underlying diseases were comparable between the 2 groups. Hs-CRP (3.93±1.43) and IL-6 (11.26±2.29) levels were significant different in the ARB group compared with the control group. The postoperative follow-up showed that ABI was 0.98±0.20 in the ARB group and 0.62±0.48 in the control group. CONCLUSIONS Valsartan inhibited the increase in hs-CRP and IL-6 levels, improved clinical efficacies, increased ABI, and decreased the restenosis rate after the interventional therapy in patients with arteriosclerosis obliterans of the lower extremities.",2020,Hs-CRP (3.93±1.43) and IL-6 (11.26±2.29) levels were significant different in the ARB group compared with the control group.,"['patients with arteriosclerosis obliterans of the lower extremities', 'Patients with Arteriosclerosis Obliterans of the Lower Extremities Undergoing Interventional Therapy', 'Patients with arteriosclerosis obliterans of the lower extremities undergoing continuous stent implantation in the superficial femoral artery']","['valsartan', 'Valsartan', 'ARB']","['total clinical effective rate', 'acute myocardial infarction', 'clinical efficacies, increased ABI', 'hs-CRP and IL-6 levels', 'ABI', 'restenosis rate', 'acute cerebral hemorrhage', 'ankle brachial index (ABI', 'Hs-CRP (3.93±1.43) and IL-6 (11.26±2.29) levels', 'concentrations of interleukin-6 (IL-6) and high-sensitivity C-reactive protein (hs-CRP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003850', 'cui_str': 'Arteriosclerosis'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0447106', 'cui_str': 'Superficial femoral artery'}]","[{'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1328319', 'cui_str': 'Ankle brachial pressure index'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0416997,Hs-CRP (3.93±1.43) and IL-6 (11.26±2.29) levels were significant different in the ARB group compared with the control group.,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yao', 'Affiliation': 'Department of Cardiology, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine of Hebei Province, Cangzhou, Hebei, China (mainland).'}, {'ForeName': 'Lixin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Interventional Vascular Surgery, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine of Hebei Province, Cangzhou, Hebei, China (mainland).'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine of Hebei Province, Cangzhou, Hebei, China (mainland).'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine of Hebei Province, Cangzhou, Hebei, China (mainland).'}, {'ForeName': 'Nana', 'Initials': 'N', 'LastName': 'Feng', 'Affiliation': 'Department of Cardiology, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine of Hebei Province, Cangzhou, Hebei, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.919977']
2450,32541662,A Feedforward Loop within the Thyroid-Brown Fat Axis Facilitates Thermoregulation.,"Thyroid hormones (TH) control brown adipose tissue (BAT) activation and differentiation, but their subsequent homeostatic response following BAT activation remains obscure. This study aimed to investigate the relationship between cold- and capsinoids-induced BAT activation and TH changes between baseline and 2 hours post-intervention. Nineteen healthy subjects underwent  18 F-fluorodeoxyglucose positron-emission tomography ( 18 F-FDG PET) and whole-body calorimetry (WBC) after 2 hours of cold exposure (~14.5 °C) or capsinoids ingestion (12 mg) in a crossover design. Standardized uptake values (SUV-mean) of the region of interest and energy expenditure (EE) were measured. Plasma free triiodothyronine (FT3), free thyroxine (FT4) and thyroid stimulating hormone (TSH) were measured before and 2 hours after each intervention. Subjects were divided into groups based on the presence (n = 12) or absence (n = 7) of BAT after cold exposure. 12 of 19 subjects were classified as BAT-positive. Subjects with BAT had higher baseline FT3 concentration, baseline FT3/FT4 ratio compared with subjects without BAT. Controlling for body fat percentage, FT3 concentration at baseline was associated with EE change from baseline after cold exposure (P = 0.037) and capsinoids (P = 0.047). Plasma FT4 level significantly increased associated with reciprocal decline in TSH after acute cold exposure and capsinoids independently of subject and treatment status. Circulating FT3 was higher in BAT-positive subjects and was a stronger predictor of EE changes after cold exposure and capsinoids in healthy humans. BAT activation elevates plasma FT4 acutely and may contribute towards augmentation of thermogenesis via a positive feedback response.",2020,Circulating FT3 was higher in BAT-positive subjects and was a stronger predictor of EE changes after cold exposure and capsinoids in healthy humans.,"['12 of 19 subjects were classified as BAT-positive', 'healthy humans', 'Nineteen healthy subjects underwent']",['18 F-fluorodeoxyglucose positron-emission tomography ( 18 F-FDG PET) and whole-body calorimetry (WBC) after 2\u2009hours of cold exposure (~14.5\u2009°C) or capsinoids ingestion'],"['Plasma FT4 level', 'Thyroid hormones (TH) control brown adipose tissue (BAT) activation and differentiation', 'BAT activation and TH changes', 'body fat percentage, FT3 concentration', 'baseline FT3 concentration, baseline FT3/FT4 ratio', 'Standardized uptake values (SUV-mean) of the region of interest and energy expenditure (EE', 'Circulating FT3', 'Plasma free triiodothyronine (FT3), free thyroxine (FT4) and thyroid stimulating hormone (TSH']","[{'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0006298', 'cui_str': 'Brown fat'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0302995', 'cui_str': 'Fluorine-18'}, {'cui': 'C3641247', 'cui_str': 'FDG PET scan'}, {'cui': 'C0046056', 'cui_str': 'Fluorodeoxyglucose F18'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0006779', 'cui_str': 'Calorimetry'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0231275', 'cui_str': 'Cold exposure'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006298', 'cui_str': 'Brown fat'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0560014', 'cui_str': 'ft3'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0370097', 'cui_str': 'Free triiodothyronine'}, {'cui': 'C0202225', 'cui_str': 'T4 free measurement'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}]",19.0,0.0475415,Circulating FT3 was higher in BAT-positive subjects and was a stronger predictor of EE changes after cold exposure and capsinoids in healthy humans.,"[{'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Singapore Institute for Clinical Sciences, Agency for Science, Technology and Research (A*STAR), Singapore, Singapore.'}, {'ForeName': 'Hui Jen', 'Initials': 'HJ', 'LastName': 'Goh', 'Affiliation': 'Singapore Institute for Clinical Sciences, Agency for Science, Technology and Research (A*STAR), Singapore, Singapore.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Govindharajulu', 'Affiliation': 'Singapore Institute of Food and Biotechnology Innovation, Agency for Science, Technology and Research (A*STAR), Singapore, Singapore.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Cardiovascular and Metabolic Disorders Program, Duke-NUS Medical School, Singapore, Singapore.'}, {'ForeName': 'Christiani Jeyakumar', 'Initials': 'CJ', 'LastName': 'Henry', 'Affiliation': 'Singapore Institute of Food and Biotechnology Innovation, Agency for Science, Technology and Research (A*STAR), Singapore, Singapore.'}, {'ForeName': 'Melvin Khee-Shing', 'Initials': 'MK', 'LastName': 'Leow', 'Affiliation': 'Singapore Institute for Clinical Sciences, Agency for Science, Technology and Research (A*STAR), Singapore, Singapore. melvin_leow@sics.a-star.edu.sg.'}]",Scientific reports,['10.1038/s41598-020-66697-0']
2451,32548581,Transcranial Direct Current Stimulation to Optimise Participation in Stroke Rehabilitation - A Sham-Controlled Cross-Over Feasibility Study.,"Background


Fatigue and attentional decline limit the duration of many therapy sessions in older adults poststroke. Transcranial direct current stimulation (tDCS) may facilitate participation in rehabilitation, potentially via reduced fatigue and improved sustained attention poststroke.
Objective


To evaluate whether tDCS results in an increase in the number of completed rehabilitation therapy sessions in stroke survivors.
Methods


Nineteen participants were randomly allocated to receive 10 sessions of 2-mA anodal (excitatory) tDCS, or sham tDCS, applied to the left dorsolateral prefrontal cortex (DLPFC) for 20 minutes within 1 hour prior to the first rehabilitation therapy session of the day. After a 2-day washout period, participants then crossed-over. Researchers applying the tDCS, and those recording measures were blinded to group allocation. The number of first rehabilitation therapy sessions completed as planned, as well as the total duration of rehabilitation therapy, were used to determine the influence of tDCS on participation in stroke rehabilitation.
Results


The total number of first therapy sessions completed as planned did not vary according to group allocation (111 of 139 sessions for tDCS, 110 of 147 sessions for sham treatment; chi-square 1.0;  P  = .31).
Conclusions


Our results suggest that, while tDCS to the DLPFC was well tolerated, it did not significantly influence the number of completed rehabilitation therapy sessions in stroke survivors.",2020,"The total number of first therapy sessions completed as planned did not vary according to group allocation (111 of 139 sessions for tDCS, 110 of 147 sessions for sham treatment; chi-square 1.0;  P  = .31).
","['older adults poststroke', 'stroke survivors', 'Methods\n\n\nNineteen participants']","['Transcranial direct current stimulation (tDCS', 'Transcranial Direct Current Stimulation to Optimise Participation', 'tDCS', '2-mA anodal (excitatory) tDCS, or sham tDCS, applied to the left dorsolateral prefrontal cortex (DLPFC']",[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450337', 'cui_str': '19'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0450424', 'cui_str': 'To the left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}]",[],19.0,0.0270313,"The total number of first therapy sessions completed as planned did not vary according to group allocation (111 of 139 sessions for tDCS, 110 of 147 sessions for sham treatment; chi-square 1.0;  P  = .31).
","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Etherton-Beer', 'Affiliation': 'WA Centre for Health and Ageing and School of Medicine and Pharmacology, The University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Yee', 'Initials': 'Y', 'LastName': 'Lui', 'Affiliation': 'Physiotherapy, Bentley Health Service, Bentley, WA, Australia.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Radalj', 'Affiliation': 'Occupational Therapy, Bentley Health Service, Bentley, WA, Australia.'}, {'ForeName': 'Ann-Maree', 'Initials': 'AM', 'LastName': 'Vallence', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, Murdoch, WA, Australia.'}, {'ForeName': 'Barby', 'Initials': 'B', 'LastName': 'Singer', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, WA, Australia.'}]",Neuroscience insights,['10.1177/2633105520922181']
2452,32548619,"Sublobar resection versus lobectomy for patients with resectable stage I non-small cell lung cancer with idiopathic pulmonary fibrosis: a phase III study evaluating survival (JCOG1708, SURPRISE).","The standard treatment for the patients with surgically resectable early non-small cell lung cancer (NSCLC) is lung lobectomy. However, if patients have idiopathic pulmonary fibrosis combined with early stage lung cancer, there is no standard treatment for this population. Patients with idiopathic pulmonary fibrosis have chronic progressive decline in respiratory function; thus, the preservation of respiratory function is essential. The aim of this trial is to confirm the clinical effectiveness of sublobar resection such as wedge resection or segmentectomy for early NSCLC with idiopathic pulmonary fibrosis compared with lobectomy in a randomized phase III trial. The primary endpoint is overall survival. If the non-inferiority of overall survival and minimal invasiveness are proven, it can be a new standard treatment for early NSCLC with idiopathic pulmonary fibrosis. A planned total 430 patients will be enrolled from 50 institutions over 5 years. This trial has been registered in the UMIN Clinical Trials Registry with code UMIN000032696 [http://www.umin.ac.jp/ctr/index.htm].",2020,"If the non-inferiority of overall survival and minimal invasiveness are proven, it can be a new standard treatment for early NSCLC with idiopathic pulmonary fibrosis.","['patients have idiopathic pulmonary fibrosis combined with early stage lung cancer', 'A planned total 430 patients will be enrolled from 50 institutions over 5\xa0years', 'Patients with idiopathic pulmonary fibrosis have chronic progressive decline in respiratory function', 'patients with surgically resectable early non-small cell lung cancer (NSCLC) is lung lobectomy', 'early NSCLC with idiopathic pulmonary fibrosis', 'patients with resectable stage I non-small cell lung cancer with idiopathic pulmonary fibrosis']","['Sublobar resection versus lobectomy', 'sublobar resection such as wedge resection or segmentectomy']",['overall survival'],"[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0189497', 'cui_str': 'Lobectomy of lung'}, {'cui': 'C0278504', 'cui_str': 'Non-small cell lung cancer stage I'}]","[{'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0184909', 'cui_str': 'Wedge resection - action'}, {'cui': 'C0024885', 'cui_str': 'Partial mastectomy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",430.0,0.0933941,"If the non-inferiority of overall survival and minimal invasiveness are proven, it can be a new standard treatment for early NSCLC with idiopathic pulmonary fibrosis.","[{'ForeName': 'Kiyo', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Tsutani', 'Affiliation': 'Department of Surgical Oncology, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Wakabayashi', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Mizutani', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Keiju', 'Initials': 'K', 'LastName': 'Aokage', 'Affiliation': 'Division of Thoracic Surgery, National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Miyata', 'Affiliation': 'Department of Surgical Oncology, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Kuroda', 'Affiliation': 'Department of Thoracic Surgery, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Saji', 'Affiliation': 'Department of Chest Surgery, St. Marianna University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Shun-Ichi', 'Initials': 'SI', 'LastName': 'Watanabe', 'Affiliation': 'Division of Thoracic Surgery, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Morihito', 'Initials': 'M', 'LastName': 'Okada', 'Affiliation': 'Department of Surgical Oncology, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Japanese journal of clinical oncology,['10.1093/jjco/hyaa092']
2453,32548624,Long-term clinical outcomes of losartan in patients with Marfan syndrome: follow-up of the multicentre randomized controlled COMPARE trial.,"AIMS


The COMPARE trial showed a small but significant beneficial effect of 3-year losartan treatment on aortic root dilatation rate in adults with Marfan syndrome (MFS). However, no significant effect was found on clinical endpoints, possibly due to a short follow-up period. The aim of the current study was therefore to investigate the long-term clinical outcomes after losartan treatment.
METHODS AND RESULTS


In the original COMPARE study (inclusion 2008-2009), adult patients with MFS (n = 233) were randomly allocated to either the angiotensin-II receptor blocker losartan® on top of regular treatment (β-blockers in 71% of the patients) or no additional medication. After the COMPARE trial period of 3 years, study subjects chose to continue their losartan medication or not. In a median follow-up period of 8 years, 75 patients continued losartan medication, whereas 78 patients, originally allocated to the control group, never used losartan after inclusion. No differences existed between baseline characteristics of the two groups except for age at inclusion [losartan 34 (interquartile range, IQR 26-43) years, control 41 (IQR 30-52) years; P = 0.031], and β-blocker use (losartan 81%, control 64%; P = 0.022). A pathological FBN1 mutation was present in 76% of patients and 58% of the patients were male. Clinical endpoints, defined as all-cause mortality, aortic dissection/rupture, elective aortic root replacement, reoperation, and vascular graft implantation beyond the aortic root, were compared between the two groups. A per-patient composite endpoint was also analysed. Five deaths, 14 aortic dissections, 23 aortic root replacements, 3 reoperations, and 3 vascular graft implantations beyond the aortic root occurred during follow-up. Except for aortic root replacement, all endpoints occurred in patients with an operated aortic root. Patients who used losartan during the entire follow-up period showed a reduced number of events compared to the control group (death: 0 vs. 5, P = 0.014; aortic dissection: 3 vs. 11, P = 0.013; elective aortic root replacement: 10 vs. 13, P = 0.264; reoperation: 1 vs. 2, P = 0.463; vascular graft implantations beyond the aortic root 0 vs. 3, P = 0.071; and composite endpoint: 14 vs. 26, P = 0.019). These results remained similar when corrected for age and β-blocker use in a multivariate analysis.
CONCLUSION


These results suggest a clinical benefit of combined losartan and β-blocker treatment in patients with MFS.",2020,"Patients who used losartan during the entire follow-up period showed a reduced number of events compared to the control group (death: 0 vs. 5, P = 0.014; aortic dissection:","['adult patients with MFS (n\u2009=\u2009233', 'patients with Marfan syndrome', 'patients with MFS', 'adults with Marfan syndrome (MFS']","['angiotensin-II receptor blocker losartan® on top of regular treatment (β-blockers in 71% of the patients) or no additional medication', 'losartan']","['aortic root dilatation rate', 'vascular graft implantations', 'vascular graft implantations beyond the aortic root', 'cause mortality, aortic dissection/rupture, elective aortic root replacement, reoperation, and vascular graft implantation beyond the aortic root', 'number of events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024796', 'cui_str': ""Marfan's syndrome""}]","[{'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0238669', 'cui_str': 'Aortic root dilatation'}, {'cui': 'C0740038', 'cui_str': 'Vascular graft'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0549113', 'cui_str': 'Supraaortic valve area structure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0340643', 'cui_str': 'Dissection of aorta'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.0400686,"Patients who used losartan during the entire follow-up period showed a reduced number of events compared to the control group (death: 0 vs. 5, P = 0.014; aortic dissection:","[{'ForeName': 'Mitzi M', 'Initials': 'MM', 'LastName': 'van Andel', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Indrakusuma', 'Affiliation': 'Department of Vascular Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Jalalzadeh', 'Affiliation': 'Department of Vascular Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Balm', 'Affiliation': 'Department of Vascular Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Janneke', 'Initials': 'J', 'LastName': 'Timmermans', 'Affiliation': 'Department of Cardiology, St. Radboud University Medical Center, Geert grooteplein 10, 6525 GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Arthur J', 'Initials': 'AJ', 'LastName': 'Scholte', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Albinusdreef 2, 2333 AZ, Leiden, The Netherlands.'}, {'ForeName': 'Maarten P', 'Initials': 'MP', 'LastName': 'van den Berg', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, Hanzeplein 1, 9713 GZ Groningen, The Netherlands.'}, {'ForeName': 'Aeilko H', 'Initials': 'AH', 'LastName': 'Zwinderman', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Barbara J M', 'Initials': 'BJM', 'LastName': 'Mulder', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'de Waard', 'Affiliation': 'Department of Medical Biochemistry, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Groenink', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}]",European heart journal,['10.1093/eurheartj/ehaa377']
2454,32548691,Concentration of circulating microparticles: a new biomarker of acute heart failure after cardiac surgery with cardiopulmonary bypass.,"Acute heart failure (AHF) is a severe complication after cardiac surgery with cardiopulmonary bypass (CPB). Although some AHF biomarkers have been used in clinic, they have limitations when applied in the prediction and diagnosis of AHF after cardiac surgery with CPB, and there are still no effective and specific biomarkers. We and other researchers have shown that circulating microparticles (MPs) increased in a variety of cardiovascular diseases. However, whether the concentration of circulating MPs could be a new biomarker for AHF after cardiac surgery remains unknown. Here, 90 patients undergoing cardiac surgery with CPB and 45 healthy subjects were enrolled. Patients were assigned into AHF (n=14) or non-AHF (n=76) group according to the diagnosis criteria of AHF. The concentrations of circulating MPs were determined before, as well as 12 h and 3 days after operation with nanoparticle tracking analysis technique. MPs concentrations in patients before surgery were significantly higher than those of healthy subjects. Plasma levels of MPs were significantly elevated at 12 h after surgery in patients with AHF, but not in those without AHF, and the circulating MPs concentrations at 12 h after surgery were higher in AHF group compared with non-AHF group. Logistic regression analysis indicated that MPs concentration at postoperative 12 h was an independent risk factor for AHF. The area under receiver operating characteristic curve for MPs concentration at postoperative 12 h was 0.81 and the best cut-off value is 5.20×10 8  particles mL -1  with a sensitivity of 93% and a specificity of 10%. These data suggested that the concentration of circulating MPs might be a new biomarker for the occurrence of AHF after cardiac surgery with CPB.",2020,"Plasma levels of MPs were significantly elevated at 12 h after surgery in patients with AHF, but not in those without AHF, and the circulating MPs concentrations at 12 h after surgery were higher in AHF group compared with non-AHF group.","['90 patients undergoing cardiac surgery with CPB and 45 healthy subjects were enrolled', 'acute heart failure after cardiac surgery with cardiopulmonary bypass']","['AHF (n=14) or non-AHF', 'cardiac surgery with cardiopulmonary bypass (CPB']","['MPs concentrations', 'MPs concentration', 'circulating MPs concentrations', 'Plasma levels of MPs', 'concentrations of circulating MPs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}]","[{'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2350307', 'cui_str': 'Microparticles, Cell-Derived'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",90.0,0.0302985,"Plasma levels of MPs were significantly elevated at 12 h after surgery in patients with AHF, but not in those without AHF, and the circulating MPs concentrations at 12 h after surgery were higher in AHF group compared with non-AHF group.","[{'ForeName': 'Yuquan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Division of Cardiac Surgery, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, 510080, China.'}, {'ForeName': 'Haoxiang', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': 'Division of Cardiac Surgery, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, 510080, China.'}, {'ForeName': 'Caiyun', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, 510080, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Division of Cardiac Surgery, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, 510080, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Division of Cardiac Surgery, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, 510080, China.'}, {'ForeName': 'Yating', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Division of Cardiac Surgery, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, 510080, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Division of Cardiac Surgery, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, 510080, China.'}, {'ForeName': 'Yupeng', 'Initials': 'Y', 'LastName': 'Jian', 'Affiliation': 'Division of Cardiac Surgery, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, 510080, China.'}, {'ForeName': 'Donghong', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Ultrasound, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, 510080, China.'}, {'ForeName': 'Zhijun', 'Initials': 'Z', 'LastName': 'Ou', 'Affiliation': 'National-Guangdong Joint Engineering Laboratory for Diagnosis and Treatment of Vascular Diseases, Guangzhou, 510080, China.'}, {'ForeName': 'Jingsong', 'Initials': 'J', 'LastName': 'Ou', 'Affiliation': 'Division of Cardiac Surgery, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, 510080, China. oujs@mail.sysu.edu.cn.'}]",Science China. Life sciences,['10.1007/s11427-020-1708-9']
2455,32548904,Evaluation of the Efficacy of Ultrapulsed CO 2  Laser in Chronic Wounds.,"BACKGROUND AND OBJECTIVES


Chronic wound repair is a major problem in wound treatment. Recently, several studies have suggested that carbon dioxide (CO 2  ) laser can be used to improve the healing of chronic wounds. The aim of the present study was to preliminarily investigate the efficacy of laser debridement in treating chronic wound through a comparison of traditional instrument/surgical debridement with the ultrapulsed CO 2  laser debridement in terms of wound healing, wound infection control, and wound blood perfusion.
STUDY DESIGN/MATERIALS AND METHODS


Patients with chronic wound admitted to the Wound Repair Clinic at The Affiliated Hospital of Southwest Medical University (Luzhou, China) between February 2019 and May 2019 were enrolled. They were randomly divided into two groups. The patients in one group were treated with traditional sharp instrument/surgical debridement (RT group; number of wounds: 28), while the patients in the other group were treated with ultrapulsed CO 2  laser debridement (LT group; number of wounds: 26). An intergroup comparison was performed based on parameters, such as wound healing, wound infection control, and changes in wound blood perfusion.
RESULTS


The wound healing rate and the total time to achieve healing were significantly better in the LT group versus the RT group at 7, 14, 21, and 28 days after treatment. The wound exudation scores were significantly higher in the LT group versus the RT group at 7, 14, and 28 days after treatment. The positive rate of pre-debridement bacterial culture was significantly lower in the LT group versus the RD group at 14 and 28 days after treatment. The percentage of wound perfusion/normal periwound skin perfusion was significantly higher in the LT group versus the RT group at 1, 7, and 14 days after treatment.
CONCLUSION


For the treatment of chronic refractory wounds, the ultrapulsed CO 2  laser exhibits higher accuracy, more effectively controls wound infection, promotes an increase in wound blood perfusion, and achieves faster wound healing compared with traditional sharp instrument/surgical debridement. Lasers Surg. Med. © 2020 Wiley Periodicals LLC.",2020,"The percentage of wound perfusion/normal periwound skin perfusion was significantly higher in the LT group versus the RT group at 1, 7, and 14 days after treatment.
","['Patients with chronic wound admitted to the Wound Repair Clinic at The Affiliated Hospital of Southwest Medical University (Luzhou, China) between February 2019 and May 2019 were enrolled', 'Chronic Wounds']","['laser debridement', 'ultrapulsed CO 2  laser debridement', 'traditional sharp instrument/surgical debridement (RT', 'Ultrapulsed CO 2  Laser', 'carbon dioxide (CO 2  ) laser']","['wound healing, wound infection control, and changes in wound blood perfusion', 'wound exudation scores', 'wound healing, wound infection control, and wound blood perfusion', 'wound healing rate and the total time to achieve healing', 'positive rate of pre-debridement bacterial culture', 'wound healing', 'percentage of wound perfusion/normal periwound skin perfusion', 'wound blood perfusion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0336668', 'cui_str': 'Sharp instrument'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0311437', 'cui_str': 'Exudation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0430402', 'cui_str': 'Bacterial culture'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]",,0.0252332,"The percentage of wound perfusion/normal periwound skin perfusion was significantly higher in the LT group versus the RT group at 1, 7, and 14 days after treatment.
","[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Jiang', 'Affiliation': 'Department of Plastic and Burn Surgery, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, 646000, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Tang', 'Affiliation': 'Department of Plastic and Burn Surgery, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, 646000, China.'}, {'ForeName': 'Danyu', 'Initials': 'D', 'LastName': 'Zheng', 'Affiliation': 'Department of Plastic and Burn Surgery, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, 646000, China.'}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Plastic and Burn Surgery, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, 646000, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Plastic and Burn Surgery, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, 646000, China.'}, {'ForeName': 'Ruxi', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Department of Plastic and Burn Surgery, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, 646000, China.'}, {'ForeName': 'Ligang', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Plastic and Burn Surgery, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, 646000, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': 'Department of Plastic and Burn Surgery, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, 646000, China.'}]",Lasers in surgery and medicine,['10.1002/lsm.23283']
2456,32548906,Participation in a randomised controlled trial for older adults with osteoarthritis in Portugal: Analysis of the acceptance factors.,"Fit & Strong! is an evidence-based program that combines exercise with health education for older adults with lower extremity osteoarthritis. This paper explores the factors of acceptance to a randomised controlled trial that tested the Portuguese (Europe) version of Fit & Strong! and analysed the sociodemographic, lifestyle and health characteristics of people who agreed versus people who declined to participate. Patients were identified by General Practitioners at three healthcare centres during 4 months (May 2017 to July 2017). Patients who accepted the invitation and met the inclusion criteria are designated participants, and people who met the inclusion criteria, declined the opportunity to participate but agreed to answer a brief questionnaire are designated as non-participants. Data included sociodemographic, lifestyle behaviours, health, pain and ADLs from the Western Ontario and McMaster Universities Osteoarthritis. Data were analysed using descriptive analysis and the Wilcoxon-Mann-Whitney, Chi-Squared tests or Fisher's tests. The results showed that three out of 12 (25%) primary healthcare centres contacted about the new program accepted the invitation to participate in recruitment. Eighty-two patients were contacted, of whom 14 (17.2%) did not meet inclusion criteria and 32 (38.3%) met the inclusion criteria but declined to participate. The acceptance rate was 22%. Non-participants were older (U = 41.0; W = 212.0; p = .044) and experienced earlier osteoarthritis onset than participants (U = 26.0; W = 146.0; p = .031). In conclusion, younger age and a diagnosis of osteoarthritis more recent appear to predispose older adults with osteoarthritis to be more accepting of participation in a non-pharmacologic intervention designed to increase physical activity.",2020,Non-participants were older,"['older adults with lower extremity osteoarthritis', 'people who agreed versus people who declined to participate', 'Patients were identified by General Practitioners at three healthcare centres during 4\xa0months (May 2017 to July 2017', 'Eighty-two patients were contacted, of whom 14 (17.2%) did not meet inclusion criteria and 32 (38.3%) met the inclusion criteria but declined to participate', 'Non-participants were older', 'Patients who accepted the invitation and met the inclusion criteria are designated participants, and people who met the inclusion criteria, declined the opportunity to participate but agreed to answer a brief questionnaire are designated as non-participants', 'older adults with osteoarthritis in Portugal']",[],"['sociodemographic, lifestyle behaviours, health, pain and ADLs', 'acceptance rate', 'earlier osteoarthritis onset']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1136454', 'cui_str': 'Refusal to Participate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0032729', 'cui_str': 'Portugal'}]",[],"[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]",82.0,0.0537989,Non-participants were older,"[{'ForeName': 'Natália', 'Initials': 'N', 'LastName': 'Duarte', 'Affiliation': 'ICBAS, CINTESIS, University of Porto, Porto, Portugal.'}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Santos', 'Affiliation': 'ICBAS, USF Argoncilhe, University of Porto, Porto, Portugal.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Hughes', 'Affiliation': 'Community Health Sciences, School of Public Health and Director, Center for Research on Health and Aging, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Constança', 'Initials': 'C', 'LastName': 'Paúl', 'Affiliation': 'ICBAS, CINTESIS, University of Porto, Porto, Portugal.'}]",Health & social care in the community,['10.1111/hsc.13058']
2457,32548907,Examining associative conditioning with a positive peer context as a strategy to increase children's vegetable acceptance.,"BACKGROUND


Children's vegetable acceptance increases following repeated exposure and associative conditioning pairing a target vegetable with a well-liked food. Yet traditional pairings may increase energy intake when well-liked foods are calorie-rich.
OBJECTIVES


To examine whether pairing a non-food stimulus with target vegetables increases children's vegetable acceptance and whether effects exceed those of repeated exposure.
METHODS


Twenty-three 6-to-8-year-old children participated in twice-weekly sessions across 6 weeks of a summer camp serving children from low-income families. First- and second-grade camp classrooms were randomly assigned to associative conditioning and repeated exposure groups, respectively. Liking and preference were assessed for seven vegetables at pre/post-test. For each child, two non-preferred vegetables were randomly assigned as the target or control. During exposures, associative conditioning group children experienced a positive peer context (involving group games) paired with tasting their target vegetable. The repeated exposure group received only taste exposures; target vegetable liking was assessed.
RESULTS


Preferences for target vegetables increased from pre- (Median = 6.00) to post-test (Median = 3.00) overall (P = .007), but did not differ by group (P = .59). Group, time and interaction effects on vegetable liking were non-significant overall (P ≥ .29), with some evidence of group differences when examining select time points.
CONCLUSIONS


Findings can inform future research aiming to increase vegetable preferences in community settings.",2020,"Group, time and interaction effects on vegetable liking were non-significant overall (P ≥ .29), with some evidence of group differences when examining select time points.
","['First- and second-grade camp classrooms', '6-to-8-year-old children', 'Twenty-three', 'For each child, two non-preferred vegetables']","['associative conditioning group children experienced a positive peer context (involving group games) paired with tasting their target vegetable', 'repeated exposure group received only taste exposures; target vegetable liking was assessed']","['time and interaction effects on vegetable liking', 'Liking and preference']","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}]",,0.0967871,"Group, time and interaction effects on vegetable liking were non-significant overall (P ≥ .29), with some evidence of group differences when examining select time points.
","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Tauriello', 'Affiliation': 'Department of Pediatrics, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bowker', 'Affiliation': 'Department of Psychology, College of Arts and Sciences, University at Buffalo, Buffalo, New York, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Wilding', 'Affiliation': 'Department of Biostatistics, School of Public Health and Health Professions, University at Buffalo, Buffalo, New York, USA.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Epstein', 'Affiliation': 'Department of Pediatrics, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Anzman-Frasca', 'Affiliation': 'Department of Pediatrics, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York, USA.'}]",Pediatric obesity,['10.1111/ijpo.12660']
2458,32546045,The Effect of Ibuprofen Dosing Interval on Post-Tonsillectomy Outcomes in Children: A Quality Improvement Study.,"OBJECTIVE


In this Quality Improvement (QI project) it was hypothesized that an increase in dosing intervals for postoperative analgesia when alternating Ibuprofen and Acetaminophen would reduce post-tonsillectomy hemorrhage (PTH) rates for those undergoing tonsillectomies with or without adenoidectomy, while maintaining the standard of postoperative analgesia and reducing visits to the Emergency Room (ER) for reasons other than PTH. Data was collected from 353 children. Utilizing run chart analysis, it was determined that patients experiencing the 4-hour dosing interval had lower rates of PTH, fewer ER visits, and no increase in postoperative phone calls from caregivers.
PATIENTS AND METHODS


Patients were treated with standing Acetaminophen 15 mg/kg q6h and Ibuprofen 10 mg/kg q6h for postoperative analgesia from July of 2017 until January of 2018. Starting January of 2018 through November of 2018, the dosage interval was lengthened 1 hour. Data relating to PTH, ER visits for reasons other than bleeding, and phone calls from caregivers was collected.
RESULTS


Run charts were used to assess outcomes regarding PTH, postoperative visits to the ER for reasons other than PTH, and phone calls from caregivers. Our results suggest that a standing protocol of alternating Acetaminophen and Ibuprofen given every 4 hours improves the post-tonsillectomy hemorrhage rate without increasing ER visits or calls about pain.
CONCLUSIONS


This data shows promise in reducing PTH and ER visits with a longer dose interval when alternating Acetaminophen and Ibuprofen for postoperative analgesia in tonsillectomy patients. A randomized clinical trial should be carried out to further validate these claims.",2020,"Utilizing run chart analysis, it was determined that patients experiencing the 4-hour dosing interval had lower rates of PTH, fewer ER visits, and no increase in postoperative phone calls from caregivers.
","['Patients were treated with', 'Children', '353 children', 'tonsillectomy patients']","['Acetaminophen and Ibuprofen', 'standing Acetaminophen 15\u2009mg/kg q6h and Ibuprofen 10\u2009mg/kg q6h for postoperative analgesia', 'Ibuprofen and Acetaminophen', 'Ibuprofen']","['Quality Improvement (QI project', 'post-tonsillectomy hemorrhage (PTH) rates', 'rates of PTH, fewer ER visits', 'post-tonsillectomy hemorrhage rate', 'postoperative phone calls']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0585325', 'cui_str': 'Every six hours'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]","[{'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}]",353.0,0.116173,"Utilizing run chart analysis, it was determined that patients experiencing the 4-hour dosing interval had lower rates of PTH, fewer ER visits, and no increase in postoperative phone calls from caregivers.
","[{'ForeName': 'Grayson', 'Initials': 'G', 'LastName': 'Mast', 'Affiliation': 'School of Medicine, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Krysta', 'Initials': 'K', 'LastName': 'Henderson', 'Affiliation': 'West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Michele M', 'Initials': 'MM', 'LastName': 'Carr', 'Affiliation': 'Department of Otolaryngology, University at Buffalo, Buffalo, NY, USA.'}]","The Annals of otology, rhinology, and laryngology",['10.1177/0003489420934843']
2459,32534843,Gabapentin as an Adjunct to Paracervical Block for Perioperative Pain Management for First Trimester Uterine Aspiration: A Randomized Controlled Trial.,"BACKGROUND


Pain management approaches during uterine aspiration vary, with methods including local anesthetic, oral analgesics, moderate sedation, deep sedation, or a combination of approaches. For local anesthetic approaches specifically, we continue to have suboptimal pain control [1]. Gabapentin as an adjunct to pain management has proven to be beneficial in gynecological surgery. We sought to evaluate the impact of gabapentin on perioperative pain during surgical management of first trimester abortion or early pregnancy loss with uterine aspiration under local anesthesia.
OBJECTIVES


We hypothesized that adding gabapentin to local anesthesia will reduce perioperative and postoperative pain associated with uterine aspiration. Secondary outcomes included: tolerability of gabapentin, and postoperative pain, nausea, vomiting, and anxiety.
STUDY DESIGN


We conducted a randomized double-blinded placebo-controlled trial of gabapentin 600 mg given 1-2 hours pre-operatively among subjects receiving a 1 st  trimester uterine aspiration under paracervical block in an outpatient ambulatory surgery center. There were 111 subjects randomized. The primary outcome was pain at time of uterine aspiration as measured on a 100-mm visual analog scale (VAS). Secondary outcomes included pain at other perioperative time points. To assess changes in pain measures, an intention to treat (ITT) mixed effects model was fit with treatment group (Gabapentin vs. Control) as a between-subjects factor and time point as a within-subjects factor plus their interaction term. Due to a non-normal distribution of pain scores, area under the curve was calculated for secondary outcomes with comparison of groups utilizing Mann Whitney U tests.
RESULTS


Among the 111 randomized, most subjects were Black/African American (69.4%), mean age was 26 years (+/-5.5), and mean gestational age was 61.3 days, (SD 14.10). Mean pain scores at time of uterine aspiration were 66.77 (Gabapentin) vs. 71.06 (placebo), with a mean difference of -3.38 (p=0.51). There were no significant changes in pain score preoperatively or intraoperatively. Subjects who received gabapentin had significantly lower levels of pain at 10 minutes post surgery [mean difference (SE) = -13.0(-5.0), p-value = 0.01] and 30 minutes post surgery [-10.8(-5.1), p=0.03] compared to subjects who received placebo. Median nausea scores and incidence of emesis pre- and postoperatively did not differ between groups. Similarly, anxiety scores did not differ between groups, pre- or post-procedure. At 10 and 30 minutes post-procedure, most participants reported no or mild side effects and this did not differ between groups.
CONCLUSION


Preoperative gabapentin did not reduce pain during uterine aspiration. However, it did reduce postoperative pain, which may prove to be a desired attribute of its use, particularly in cases where postoperative pain may be a greater challenge.",2020,"At 10 and 30 minutes post-procedure, most participants reported no or mild side effects and this did not differ between groups.
","['First Trimester Uterine Aspiration', '111 subjects randomized', '111 randomized, most subjects were Black/African American (69.4%), mean age was 26 years (+/-5.5), and mean gestational age was 61.3 days, (SD 14.10', 'first trimester abortion or early pregnancy loss with uterine aspiration under local anesthesia', 'subjects receiving a 1 st  trimester uterine aspiration under paracervical block in an outpatient ambulatory surgery center']","['gabapentin', 'Paracervical Block', 'Gabapentin', 'placebo']","['pain at other perioperative time points', 'levels of pain', 'perioperative pain', 'postoperative pain', 'tolerability of gabapentin, and postoperative pain, nausea, vomiting, and anxiety', 'Median nausea scores and incidence of emesis pre', 'mild side effects', 'pain', 'pain at time of uterine aspiration as measured on a 100-mm visual analog scale (VAS', 'pain score', 'pain measures', 'anxiety scores', 'Mean pain scores at time of uterine aspiration']","[{'cui': 'C0032979', 'cui_str': 'First trimester pregnancy'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C3830362', 'cui_str': 'Early Pregnancy Loss'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}, {'cui': 'C0032982', 'cui_str': 'Trimesters'}, {'cui': 'C0030401', 'cui_str': 'Paracervical block anesthesia'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1321139', 'cui_str': 'Ambulatory surgery center'}]","[{'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0030401', 'cui_str': 'Paracervical block anesthesia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",111.0,0.647974,"At 10 and 30 minutes post-procedure, most participants reported no or mild side effects and this did not differ between groups.
","[{'ForeName': 'Tiffany P', 'Initials': 'TP', 'LastName': 'Hailstorks', 'Affiliation': 'Department of Gynecology and Obstetrics, Emory University, School of Medicine, Atlanta, Georgia, USA. Electronic address: tiffany.p.hailstorks@emory.edu.'}, {'ForeName': 'Ms Sarah M D', 'Initials': 'MSMD', 'LastName': 'Cordes', 'Affiliation': 'Department of Gynecology and Obstetrics, Emory University, School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Carrie A', 'Initials': 'CA', 'LastName': 'Cwiak', 'Affiliation': 'Department of Gynecology and Obstetrics, Emory University, School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Gray', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University school of Medicine, Durham, NC, USA.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Ge', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Biostatistics Collaboration Core, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Reneé H', 'Initials': 'RH', 'LastName': 'Moore', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Biostatistics Collaboration Core, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Lisa B', 'Initials': 'LB', 'LastName': 'Haddad', 'Affiliation': 'Department of Gynecology and Obstetrics, Emory University, School of Medicine, Atlanta, Georgia, USA.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.06.011']
2460,32534948,Mediterranean-style dietary pattern improves cancer-related fatigue and quality of life in men with prostate cancer treated with androgen deprivation therapy: A pilot randomised control trial.,"BACKGROUND & AIMS


Cancer-related fatigue (CRF) is a prevalent and persistent symptom from androgen deprivation therapy (ADT) in prostate cancer. The Mediterranean-style dietary pattern (MED-diet) offers a plausible mechanism to mitigate CRF through reducing inflammation and improving body composition. This study aimed to evaluate the effects of a 12-week MED-diet, compared to usual care, on CRF and quality of life in men with prostate cancer treated with ADT.
METHODS


Twenty-three men (65.9 ± 7.8 years; body mass index: 29.6 ± 2.7 kg/m 2 ; ADT duration: 33.8 ± 35.6 months) receiving ADT for ≥3 months were randomly assigned (1:1) to 12-weeks of usual care or the MED-diet involving six individualised nutrition consults. Primary outcomes included CRF [Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale (FACIT-F) and quality of life [FACIT-General (FACIT-G)], secondary outcomes included body mass/composition and interleukin (IL)-6 and IL-8 concentrations measured at baseline, 8-weeks and 12 weeks. Intervention feasibility was measured by intervention safety, study completion rate, consult attendance, and adherence to the MED-diet through the Mediterranean-diet adherence screener (MEDAS). Intention to treat linear mixed models were used to determine changes in outcomes between the MED-diet and usual care at baseline, 8-weeks and 12-weeks.
RESULTS


The MED-diet improved CRF (FACIT-F) at 8-weeks [+4.8 (0.0, 9.8); P = 0.05] and 12-weeks [+7.2 (2.2, 12.0); P = 0.005], quality of life (FACIT-G) at 12-weeks [+9.2 (2.7, 15.8); P = 0.006], reduced total body mass at 8-weeks [-2.51 kg (-4.25, -0.78); P = 0.005] and 12-weeks [-2.97 kg (-4.71, -1.25); P = 0.001], lean mass at 8-weeks [-1.50 kg (-2.91, -0.10); P = 0.036], and IL-8 at 8-weeks [-0.18 ng/ml (-0.34, -0.02); P = 0.029] compared to usual care. The MED-diet demonstrated zero adverse events, 91% study completion, 100% attendance, and 81% adherence to the MEDAS.
CONCLUSION


The MED-diet is safe and feasible, and has the potential to improve CRF and quality of life in overweight men treated with ADT compared to usual care. Further exploration of the MED-diet is warranted in a larger powered sample size to consolidate these findings.",2020,"The MED-diet is safe and feasible, and has the potential to improve CRF and quality of life in overweight men treated with ADT compared to usual care.","[' body mass index: 29.6\xa0±\xa02.7\xa0kg/m 2 ; ADT duration: 33.8\xa0±\xa035.6 months) receiving ADT for ≥3 months', 'Twenty-three men (65.9\xa0±\xa07.8 years', 'men with prostate cancer treated with', 'men with prostate cancer treated with ADT']","['usual care or the MED-diet involving six individualised nutrition consults', 'Mediterranean-style dietary pattern', 'androgen deprivation therapy', 'androgen deprivation therapy (ADT']","['quality of life', 'cancer-related fatigue and quality of life', 'intervention safety, study completion rate, consult attendance, and adherence to the MED-diet through the Mediterranean-diet adherence screener (MEDAS', 'reduced total body mass', 'CRF [Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale (FACIT-F) and quality of life [FACIT-General (FACIT-G)], secondary outcomes included body mass/composition and interleukin (IL)-6 and IL-8 concentrations', 'lean mass', 'CRF and quality of life']","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0448349,"The MED-diet is safe and feasible, and has the potential to improve CRF and quality of life in overweight men treated with ADT compared to usual care.","[{'ForeName': 'Brenton J', 'Initials': 'BJ', 'LastName': 'Baguley', 'Affiliation': 'Institute of Physical Activity and Nutrition, Deakin University, Geelong, Australia; School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, QLD, Australia. Electronic address: b.baguley@deakin.edu.au.'}, {'ForeName': 'Tina L', 'Initials': 'TL', 'LastName': 'Skinner', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Jenkins', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, QLD, Australia; School of Health and Sport Sciences, University of the Sunshine Coast, Sippy Downs, QLD, Australia.'}, {'ForeName': 'Olivia R L', 'Initials': 'ORL', 'LastName': 'Wright', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, QLD, Australia; Mater Research Institute, The University of Queensland, Brisbane, QLD, Australia.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.05.016']
2461,32534949,"TICACOS international: A multi-center, randomized, prospective controlled study comparing tight calorie control versus Liberal calorie administration study.","Since the first TICACOS study, 3 additional studies have been published comparing a medical nutrition therapy guided by indirect calorimetry to a regimen prescribed on the basis of predictive equations. A recent guidelines document included a meta-analysis including these 4 papers and found a trend for improvement (OR 0.98-1.48) in favor of medical nutrition therapy guided by indirect calorimetry in terms of survival. The aim of our study was to perform a multicenter prospective, randomized, controlled non blinded study in critically patients to assess the added value for measuring daily resting energy expenditure as a guide for nutritional support. The primary objective was to decrease infectious rate of these critically ill patients.
MATERIAL AND METHODS


This phase III, multi-center, randomized, controlled non blinded study was planned to include 580 newly-admitted, adult ventilated ICU patients that were planned to stay more than 48 h in the ICU departments. The nutritional support was aimed to meet 80-100% of energy requirement measured by indirect calorimetry. The calorie needs were determined by IC in the Study group and by an equation (20-25 kcal/kg ideal body weight/day) in the Control Group. The ICU staff was trained to strive to supply 80-100% of a patient's energy requirements through artificial nutrition, preferably enteral feeding. Primary endpoint was infection rate and secondary endpoints included other morbidities and mortality during ICU, at 90 and 180 days. Comparison between the study and the control group was performed using T test for equality of means (independent samples test). Correlations were performed using the Pearson correlation test. A p level of 0.05 or below was considered as significant. Cross tabs procedure used Chi-square test for testing differences in complication rates, length of stay and length of ventilation. Correlations between energy balances and complications was also be tested using one way analysis as well as ANOVA analysis between groups and within groups. Kaplan Meir curves assessed the proportion of surviving patients in the 2 groups.
RESULTS


Seven centers with a calorimeter available participated to the study. Due to slow inclusion rate, the study was stopped after 6 years and after inclusion of 417 patients only. From the 417 intended to treat patients, 339 followed the protocol. There was no differences between control and study groups in terms of age, sex BMI, SOFA (7.1 ± 3.1 vs 7.4 ± 3.3) and APACHE II scores (22.4 ± 7.9 vs 22.2 ± 7.4). The rate of infection (40 vs 31), including pneumonia rate, need for surgery, dialysis requirement, length of ventilation, ICU length of stay, and hospital length of stay were not different between groups. Mortality (30 in the control vs 21 in the study group) was not significantly different between groups. The decreased mortality observed in the study group when added to previous studies may have a positive effect on the meta-analysis previously published.
CONCLUSION


Tight Calorie Control guided by indirect calorimetry decreased the rate of infection and mortality but not significantly. This may be explained by the not relatively small sample size. There results together with the previous 4 prospective randomized studies, may improve the results of the meta-analysis exploring the effects of IC guided nutrition on mortality.",2020,Mortality (30 in the control vs 21 in the study group) was not significantly different between groups.,"['580 newly-admitted, adult ventilated ICU patients that were planned to stay more than 48\xa0h in the ICU departments', 'Seven centers with a calorimeter available participated to the study']",[],"['rate of infection', 'pneumonia rate, need for surgery, dialysis requirement, length of ventilation, ICU length of stay, and hospital length of stay', 'infectious rate', 'infection rate', 'complication rates, length of stay and length of ventilation', 'rate of infection and mortality', 'mortality', 'Mortality', 'morbidities and mortality during ICU']","[{'cui': 'C4517818', 'cui_str': '580'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",,0.0610169,Mortality (30 in the control vs 21 in the study group) was not significantly different between groups.,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Singer', 'Affiliation': 'Department of Intensive Care, Institute for Nutrition Research, Rabin Medical Center, Beillison Hospital, Affiliated to the Sackler School of Medicine, Tel Aviv University, Israel. Electronic address: psinger@clali.org.il.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'De Waele', 'Affiliation': 'Department of Surgical ICU, UZ Brussel, Belgium. Electronic address: Elisabeth.DeWaele@uzbrussel.be.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sanchez', 'Affiliation': 'Hospital General Reina Sofía, Murcia, Spain. Electronic address: Carmen.sanchez6@carm.es.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ruiz Santana', 'Affiliation': 'Hospital Universitario Dr Negrín, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Montejo', 'Affiliation': 'Hospital Universitario 12 de Octubre, Madrid, Spain. Electronic address: jmontejo@telefonica.net.'}, {'ForeName': 'P F', 'Initials': 'PF', 'LastName': 'Laterre', 'Affiliation': 'UCL St Luc Leuven, Belgium. Electronic address: laterre@rean.ucl.ac.be.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Soroksky', 'Affiliation': 'Intensive Care Unit, Wolfson Medical Center, Holon, Israel. Electronic address: soroksky@gmail.com.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Moscovici', 'Affiliation': 'Department of Intensive Care, Institute for Nutrition Research, Rabin Medical Center, Beillison Hospital, Affiliated to the Sackler School of Medicine, Tel Aviv University, Israel.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Kagan', 'Affiliation': 'Department of Intensive Care, Institute for Nutrition Research, Rabin Medical Center, Beillison Hospital, Affiliated to the Sackler School of Medicine, Tel Aviv University, Israel.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.05.024']
2462,32534972,"Comparison of Clinical Performance of VectorFlow and Palindrome Symmetric-Tip Dialysis Catheters: A Multicenter, Randomized Trial.","PURPOSE


To compare clinical performance of 2 widely used symmetric-tip hemodialysis catheters.
MATERIALS AND METHODS


Patients with end-stage renal disease initiating or resuming hemodialysis were randomized to receive an Arrow-Clark VectorFlow (n = 50) or Palindrome catheter (n = 50). Primary outcome was 90-d primary unassisted catheter patency. Secondary outcomes were Kt/V ([dialyzer urea clearance × total treatment time]/total volume of urea distribution), urea reduction ratio (URR), and effective blood flow (Q B ).
RESULTS


Primary unassisted patency rates with the VectorFlow catheter at 30, 60, and 90 d were 95.5% ± 3.3, 87.2% ± 7.3, and 80.6% ± 9.8, respectively, compared with 89.1% ± 6.2, 79.4% ± 10.0, and 71.5% ± 12.6 with the Palindrome catheter (P = .20). Patients with VectorFlow catheters had a mean Kt/V of 1.5 at 30-, 60-, and 90-day time points, significantly higher than the mean Kt/V of 1.3 among those with Palindrome catheters (P = .0003). URRs were not significantly different between catheters. Catheter Q B  rates exceeded National Kidney Foundation-recommended thresholds of 300 mL/min at all time points for both catheters and were similar for both catheters (median, 373 mL/min). Catheter failure, ie, poor flow rate requiring guide-wire exchange or removal, within the 90-day primary outcome occurred in 3 VectorFlow subjects and 5 Palindrome subjects (P = .72). Infection rates were similar, with 0.98 infections per 1,000 catheter days for VectorFlow catheters compared with 2.62 per 1,000 catheter days for Palindrome catheters (P = .44).
CONCLUSIONS


The 90-day primary patency rates of Palindrome and VectorFlow catheters were not significantly different, and both achieved sustained high Q B  through 90 day follow-up. However, dialysis adequacy based on Kt/V was consistently better with the VectorFlow catheter versus the Palindrome.",2020,"Catheter Q B  rates exceeded National Kidney Foundation-recommended thresholds of 300 mL/min at all time points for both catheters and were similar for both catheters (median, 373 mL/min).",['Patients with end-stage renal disease initiating or resuming hemodialysis'],"['VectorFlow catheters', 'VectorFlow catheter versus the Palindrome', 'Arrow-Clark VectorFlow (n\xa0= 50) or Palindrome catheter', 'VectorFlow and Palindrome Symmetric-Tip Dialysis Catheters']","['Kt/V ([dialyzer urea clearance', '90-day primary patency rates of Palindrome and VectorFlow catheters', 'patency rates', '90-d primary unassisted catheter patency', 'Infection rates', 'Catheter failure, ie, poor flow rate requiring guide-wire exchange or removal', 'urea distribution), urea reduction ratio (URR), and effective blood flow (Q B ', 'URRs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0336721', 'cui_str': 'Arrow'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0179747', 'cui_str': 'Dialysis catheter'}]","[{'cui': 'C0429662', 'cui_str': 'kt/V'}, {'cui': 'C1318428', 'cui_str': 'Urea clearance measurement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0181089', 'cui_str': 'Guide wire'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0429664', 'cui_str': 'Urea reduction ratio'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}]",,0.066622,"Catheter Q B  rates exceeded National Kidney Foundation-recommended thresholds of 300 mL/min at all time points for both catheters and were similar for both catheters (median, 373 mL/min).","[{'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Nadolski', 'Affiliation': 'Department of Radiology, University of Pennsylvania Perelman School of Medicine, 3400 Spruce St., 1 Silverstein, Philadelphia, PA 19104. Electronic address: gregory.nadolski@pennmedicine.upenn.edu.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Redmond', 'Affiliation': 'Department of Radiology, University of Pennsylvania Perelman School of Medicine, 3400 Spruce St., 1 Silverstein, Philadelphia, PA 19104.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Shin', 'Affiliation': 'Penn State Health Radiology, Hershey, Pennsylvania.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Shamimi-Noori', 'Affiliation': 'Department of Radiology, University of Pennsylvania Perelman School of Medicine, 3400 Spruce St., 1 Silverstein, Philadelphia, PA 19104.'}, {'ForeName': 'Ansar', 'Initials': 'A', 'LastName': 'Vance', 'Affiliation': 'Department of Radiology, University of Pennsylvania Perelman School of Medicine, 3400 Spruce St., 1 Silverstein, Philadelphia, PA 19104.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Hammelman', 'Affiliation': 'Department of Radiology, University of Pennsylvania Perelman School of Medicine, 3400 Spruce St., 1 Silverstein, Philadelphia, PA 19104.'}, {'ForeName': 'Timothy W I', 'Initials': 'TWI', 'LastName': 'Clark', 'Affiliation': 'Department of Radiology, University of Pennsylvania Perelman School of Medicine, 3400 Spruce St., 1 Silverstein, Philadelphia, PA 19104.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Cohen', 'Affiliation': 'Department of Radiology, University of Pennsylvania Perelman School of Medicine, 3400 Spruce St., 1 Silverstein, Philadelphia, PA 19104.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rudnick', 'Affiliation': 'Department of Radiology, University of Pennsylvania Perelman School of Medicine, 3400 Spruce St., 1 Silverstein, Philadelphia, PA 19104.'}]",Journal of vascular and interventional radiology : JVIR,['10.1016/j.jvir.2020.02.001']
2463,32535135,Induction of sustained unresponsiveness after egg oral immunotherapy compared to baked egg therapy in egg-allergic children.,"BACKGROUND


While desensitization and sustained unresponsiveness (SU) have been shown with egg oral immunotherapy (OIT), the benefits of baked egg (BE) therapy for egg allergy have not been well studied.
OBJECTIVE


To evaluate the safety and efficacy of BE ingestion compared to egg OIT in participants allergic to unbaked egg but tolerant to BE.
METHODS


BE tolerant but unbaked egg reactive children ages 3-16 years were randomized to 2 years of treatment with either BE or egg OIT. Double-blind, placebo-controlled food challenges (DBPCFC) were conducted after 1 and 2 years of treatment to assess for desensitization, and after 2 years of treatment followed by 8-10 weeks off of treatment to assess for SU. Mechanistic studies were conducted to assess for immune modulation. A cohort of BE reactive participants underwent egg OIT and identical DBPCFCs as a comparator group.
RESULTS


Fifty participants (median age 7.3 years) were randomized and initiated treatment. SU was achieved in 3 of 27 (11.1%) BE participants versus 10 of 23 (43.5%) egg-OIT participants (p=0.009). In the BE reactive comparator group, 7 of 39 (17.9%) participants achieved SU. More BE tolerant participants withdrew from BE versus egg OIT (29.6% versus 13%). Dosing symptom frequency in BE tolerant participants was similar with BE and egg OIT, but more frequent in BE reactive participants. Egg white-specific IgE, skin testing and basophil activation decreased similarly after BE and egg OIT.
CONCLUSION


Among children allergic to unbaked egg but tolerant to BE, those treated with egg OIT were significantly more likely to achieve SU compared to children ingesting BE.",2020,"Egg white-specific IgE, skin testing and basophil activation decreased similarly after BE and egg OIT.
","['BE tolerant but unbaked egg reactive children ages 3-16 years', 'participants allergic to unbaked egg but tolerant to BE', 'egg-allergic children', 'Fifty participants (median age 7.3 years']","['baked egg therapy', 'egg oral immunotherapy (OIT', 'BE or egg OIT', 'placebo-controlled food challenges (DBPCFC', 'egg OIT and identical DBPCFCs']","['SU', 'Egg white-specific IgE, skin testing and basophil activation']","[{'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]","[{'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0205280', 'cui_str': 'Identical'}]","[{'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C1270739', 'cui_str': 'Egg white specific immunoglobulin E'}, {'cui': 'C0037296', 'cui_str': 'Hypersensitivity skin testing'}, {'cui': 'C0004827', 'cui_str': 'Basophils'}]",50.0,0.291217,"Egg white-specific IgE, skin testing and basophil activation decreased similarly after BE and egg OIT.
","[{'ForeName': 'Edwin H', 'Initials': 'EH', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine and Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC. Electronic address: edwinkim@email.unc.edu.'}, {'ForeName': 'Tamara T', 'Initials': 'TT', 'LastName': 'Perry', 'Affiliation': ""Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, AR.""}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wood', 'Affiliation': 'Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Donald Ym', 'Initials': 'DY', 'LastName': 'Leung', 'Affiliation': 'Department of Pediatrics, National Jewish Health, Denver, CO.'}, {'ForeName': 'M Cecilia', 'Initials': 'MC', 'LastName': 'Berin', 'Affiliation': 'Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'A Wesley', 'Initials': 'AW', 'LastName': 'Burks', 'Affiliation': 'Department of Medicine and Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Christine B', 'Initials': 'CB', 'LastName': 'Cho', 'Affiliation': 'Department of Pediatrics, National Jewish Health, Denver, CO.'}, {'ForeName': 'Stacie M', 'Initials': 'SM', 'LastName': 'Jones', 'Affiliation': ""Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, AR.""}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Scurlock', 'Affiliation': ""Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, AR.""}, {'ForeName': 'Scott H', 'Initials': 'SH', 'LastName': 'Sicherer', 'Affiliation': 'Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Alice K', 'Initials': 'AK', 'LastName': 'Henning', 'Affiliation': 'Emmes, Rockville, MD.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dawson', 'Affiliation': 'Emmes, Rockville, MD.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Lindblad', 'Affiliation': 'Emmes, Rockville, MD.'}, {'ForeName': 'Marshall', 'Initials': 'M', 'LastName': 'Plaut', 'Affiliation': 'National Institutes of Health/National Institutes of Allergy and Infectious Diseases, Bethesda, MD.'}, {'ForeName': 'Hugh A', 'Initials': 'HA', 'LastName': 'Sampson', 'Affiliation': 'Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.05.040']
2464,32542352,A telephone-based guided imagery tobacco cessation intervention: results of a randomized feasibility trial.,"BACKGROUND


Evidence supports the use of guided imagery for smoking cessation; however, scalable delivery methods are needed to make it a viable approach. Telephone-based tobacco quitlines are a standard of care, but reach is limited. Adding guided imagery to quitline services might increase reach by offering an alternative approach.
PURPOSE


To develop and test the feasibility and potential impact of a guided imagery-based tobacco cessation intervention delivered using a quitline model.
METHODS


Participants for this randomized feasibility trial were recruited statewide through a quitline or community-based methods. Participants were randomized to guided imagery Intervention Condition (IC) or active behavioral Control Condition (CC). After withdrawals, there were 105 participants (IC = 56; CC = 49). The IC consisted of six sessions in which participants created guided imagery audio files. The CC used a standard six-session behavioral protocol. Feasibility measures included recruitment rate, retention, and adherence to treatment. We also assessed 6-month quit rates and consumer satisfaction.
RESULTS


Both the IC and CC protocols were feasible to deliver. We finalized protocols and materials for participants, coaches and study staff, and delivered the protocols with fidelity. We developed successful recruitment methods, and experienced high retention (6 months = 81.9%) and adherence (all sessions = 66.7%). Long-term quit rates (IC = 27.9%; CC = 38.1%) compared favorably to those of quitlines, and program satisfaction was high, suggesting that the protocols are acceptable to smokers and may contribute to smoking abstinence.
CONCLUSIONS


The guided imagery intervention is feasible and promising, suggesting that a fully powered RCT to test the efficacy of the intervention is warranted.
TRIAL REGISTRATION NUMBER


NCT02968381.",2020,"Long-term quit rates (IC = 27.9%; CC = 38.1%) compared favorably to those of quitlines, and program satisfaction was high, suggesting that the protocols are acceptable to smokers and may contribute to smoking abstinence.
",['Participants for this randomized feasibility trial were recruited statewide through a quitline or community-based methods'],"['guided imagery Intervention Condition (IC) or active behavioral Control Condition (CC', 'guided imagery intervention', 'telephone-based guided imagery tobacco cessation intervention', 'Telephone-based tobacco quitlines', 'guided imagery-based tobacco cessation intervention']","['recruitment rate, retention, and adherence to treatment', 'Long-term quit rates', '6-month quit rates and consumer satisfaction']","[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0600549', 'cui_str': 'Tobacco Cessation'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009827', 'cui_str': 'Consumer Satisfaction'}]",105.0,0.113374,"Long-term quit rates (IC = 27.9%; CC = 38.1%) compared favorably to those of quitlines, and program satisfaction was high, suggesting that the protocols are acceptable to smokers and may contribute to smoking abstinence.
","[{'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Gordon', 'Affiliation': 'College of Nursing, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Melanie L', 'Initials': 'ML', 'LastName': 'Bell', 'Affiliation': 'Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Julie S', 'Initials': 'JS', 'LastName': 'Armin', 'Affiliation': 'Department of Family and Community Medicine, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Giacobbi', 'Affiliation': 'College of Physical Activity and Sport Sciences and School of Public Health, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Uma S', 'Initials': 'US', 'LastName': 'Nair', 'Affiliation': 'Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, USA.'}]",Translational behavioral medicine,['10.1093/tbm/ibaa052']
2465,32542356,SWEAT2 Study: Effectiveness of Trunk Training on Gait and Trunk Kinematics After Stroke-A Randomized Controlled Trial.,"OBJECTIVE


Trunk training after stroke is an effective method for improving mobility, yet underlying associations leading to the observed mobility carryover effects are unknown. The purposes of this study were to investigate the effectiveness of trunk training for gait and trunk kinematics and to find explanatory variables for the mobility carryover effects.
METHODS


This study was an assessor-masked randomized controlled trial. Participants received either additional trunk training (n = 19) or cognitive training (n = 20) after subacute stroke. Outcome measures were the Tinetti Performance-Oriented Mobility Assessment (POMA), the Trunk Impairment Scale, spatiotemporal gait parameters, center-of-mass excursions, and trunk and lower limb kinematics during walking. Multivariate analysis with post hoc analysis was performed to observe treatment effects. Correlation and an exploratory regression analysis were used to examine associations with the mobility carryover effects.
RESULTS


Significant improvements after trunk training, compared with the findings for the control group, were found for the Trunk Impairment Scale, Tinetti POMA, walking speed, step length, step width, horizontal/vertical center-of-mass excursions, and trunk kinematics. No significant differences were observed in lower limb kinematics. Anteroposterior excursions of the trunk were associated with 30% of the variability in the mobility carryover effects.
CONCLUSIONS


Carryover effects of trunk control were present during ambulation. Decreased anteroposterior movements of the thorax were the main variable explaining higher scores on the Tinetti POMA Gait subscale. However, the implementation and generalizability of this treatment approach in a clinical setting are laborious and limited, necessitating further research.
IMPACT


Trunk training is an effective strategy for improving mobility after stroke. Regaining trunk control should be considered an important treatment goal early after stroke to adequately prepare patients for walking.",2020,Decreased anteroposterior movements of the thorax were the main variable explaining higher scores on the Tinetti POMA Gait subscale.,[],"['Trunk Training', 'trunk training', 'SWEAT2', 'IMPACT\n\n\nTrunk training', 'additional trunk training (n\xa0=\xa019) or cognitive training']","['Trunk Impairment Scale, Tinetti POMA, walking speed, step length, step width, horizontal/vertical center-of-mass excursions, and trunk kinematics', 'lower limb kinematics', 'Tinetti POMA Gait subscale', 'Gait and Trunk Kinematics', 'Tinetti Performance-Oriented Mobility Assessment (POMA), the Trunk Impairment Scale, spatiotemporal gait parameters, center-of-mass excursions, and trunk and lower limb kinematics during walking']",[],"[{'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C2317515', 'cui_str': 'Assessment of mobility'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]",,0.0333277,Decreased anteroposterior movements of the thorax were the main variable explaining higher scores on the Tinetti POMA Gait subscale.,"[{'ForeName': 'Tamaya', 'Initials': 'T', 'LastName': 'Van Criekinge', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Science, University of Antwerp, MOVANT/REVAKI, Universiteitsplein 1, Wilrijk, 2610 Belgium; and Multidisciplinary Motor Centre Antwerp (M2OCEAN), University of Antwerp.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Hallemans', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Science, University of Antwerp, MOVANT/REVAKI; and Multidisciplinary Motor Centre Antwerp (M2OCEAN), University of Antwerp.'}, {'ForeName': 'Nolan', 'Initials': 'N', 'LastName': 'Herssens', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Science, University of Antwerp, MOVANT/REVAKI; and Multidisciplinary Motor Centre Antwerp (M2OCEAN), University of Antwerp.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lafosse', 'Affiliation': 'RevArte Rehabilitation Hospital, Edegem, Antwerp, Belgium; and Department of Psychology, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Claes', 'Affiliation': 'RevArte Rehabilitation Hospital.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'De Hertogh', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Science, University of Antwerp, MOVANT/REVAKI; and Multidisciplinary Motor Centre Antwerp (M2OCEAN), University of Antwerp.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Truijen', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Science, University of Antwerp, MOVANT/REVAKI; and Multidisciplinary Motor Centre Antwerp (M2OCEAN), University of Antwerp.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Saeys', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Science, University of Antwerp, MOVANT/REVAKI; RevArte Rehabilitation Hospital; and Multidisciplinary Motor Centre Antwerp (M2OCEAN), University of Antwerp.'}]",Physical therapy,['10.1093/ptj/pzaa110']
2466,32542370,Effect of intravenous iron on functional outcomes in hip fracture: a randomised controlled trial.,"OBJECTIVES


to determine the safety and effect of intravenous iron sucrose on functional outcomes, delirium, nosocomial infections and transfusion requirements in older patients with hip fracture.
DESIGN


single-centre randomised, double-blind, placebo-controlled clinical trial.
SETTING AND PARTICIPANTS


orthogeriatric share care service at an academic tertiary care hospital. A total of 253 patients were recruited: 126 patients were assigned to intravenous iron and 127 to placebo.
METHODS


on days 1, 3 and 5 after admission, the iron group received 200 mg Venofer® (iron sucrose) in 100 ml saline and the placebo group 100 ml saline. The primary outcome was absolute functional gain, considered as Barthel index (BI) at discharge minus BI on admission. Secondary outcomes included incidence of postoperative delirium according to the confusion assessment method, proportion of patients recovering prior functional status at 3 months, postoperative transfusion requirements, haemoglobin at 3 months, incidence of nosocomial infections and safety.
RESULTS


the median participant age was 87 (interquartile range, 82.5-91.5) years. Most patients were female (72.7%), and the median previous BI was 81(59-95). No significant effect of intravenous iron was observed for the primary outcome: the median AFG score was 17.1 points (4.8-23.3) in the intravenous iron group and 16 points (6-26) in the placebo group (P = 0.369). No significant treatment effects were observed for other functional outcomes or secondary end points.
CONCLUSION


while we found no impact of intravenous iron sucrose on functional recovery, incidence of postoperative delirium, transfusion requirements, haemoglobin at 3 months, mortality and nosocomial infections rates in older patients with hip fracture, we did find that the intervention was safe.",2020,No significant effect of intravenous iron was observed for the primary outcome: the median AFG score was 17.1 points (4.8-23.3) in the intravenous iron group and 16 points (6-26) in the placebo group (P = 0.369).,"['group 100', 'older patients with hip fracture', 'orthogeriatric share care service at an academic tertiary care hospital', 'A total of 253 patients were recruited: 126 patients', 'the median participant age was 87 (interquartile range, 82.5-91.5) years', 'hip fracture']","['intravenous iron', 'intravenous iron sucrose', '200\xa0mg Venofer® (iron sucrose', 'ml saline', 'placebo']","['absolute functional gain, considered as Barthel index (BI) at discharge minus BI on admission', 'incidence of postoperative delirium according to the confusion assessment method, proportion of patients recovering prior functional status at 3\xa0months, postoperative transfusion requirements, haemoglobin at 3\xa0months, incidence of nosocomial infections and safety', 'functional recovery, incidence of postoperative delirium, transfusion requirements, haemoglobin at 3\xa0months, mortality and nosocomial infections rates', 'functional outcomes, delirium, nosocomial infections and transfusion requirements', 'functional outcomes', 'median AFG score']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517887', 'cui_str': '82.5'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0060241', 'cui_str': 'iron sucrose'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0529374', 'cui_str': 'Venofer'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0457453', 'cui_str': 'On admission'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0010356', 'cui_str': 'Cross infection'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001732', 'cui_str': 'Afghanistan'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",253.0,0.695799,No significant effect of intravenous iron was observed for the primary outcome: the median AFG score was 17.1 points (4.8-23.3) in the intravenous iron group and 16 points (6-26) in the placebo group (P = 0.369).,"[{'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Bielza', 'Affiliation': 'Department of Geriatric Medicine, Hospital Universitario Infanta Sofía (San Sebastián de los Reyes), Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Llorente', 'Affiliation': 'Faculty of Biomedical and Health Sciences, Department of Medicine, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Israel J', 'Initials': 'IJ', 'LastName': 'Thuissard', 'Affiliation': 'Faculty of Biomedical and Health Sciences, Department of Medicine, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Andreu-Vázquez', 'Affiliation': 'Faculty of Biomedical and Health Sciences, Department of Medicine, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Blanco', 'Affiliation': 'Faculty of Biomedical and Health Sciences, Department of Medicine, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Sanjurjo', 'Affiliation': 'Faculty of Biomedical and Health Sciences, Department of Medicine, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Néstor', 'Initials': 'N', 'LastName': 'López', 'Affiliation': 'Faculty of Biomedical and Health Sciences, Department of Medicine, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'María Regina', 'Initials': 'MR', 'LastName': 'Herráez', 'Affiliation': 'Faculty of Biomedical and Health Sciences, Department of Medicine, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Molano', 'Affiliation': 'Department of Geriatric Medicine, Hospital Universitario Infanta Sofía (San Sebastián de los Reyes), Madrid, Spain.'}, {'ForeName': 'Adoración', 'Initials': 'A', 'LastName': 'Morales', 'Affiliation': 'Department of Geriatric Medicine, Hospital Universitario Infanta Sofía (San Sebastián de los Reyes), Madrid, Spain.'}, {'ForeName': 'Estefanía', 'Initials': 'E', 'LastName': 'Arias', 'Affiliation': 'Department of Geriatric Medicine, Hospital Universitario Infanta Sofía (San Sebastián de los Reyes), Madrid, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Neira', 'Affiliation': 'Department of Geriatric Medicine, Hospital Universitario Infanta Sofía (San Sebastián de los Reyes), Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Lung', 'Affiliation': 'Department of Geriatric Medicine, Hospital Universitario Infanta Sofía (San Sebastián de los Reyes), Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escalera', 'Affiliation': 'Faculty of Biomedical and Health Sciences, Department of Medicine, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Portillo', 'Affiliation': 'Faculty of Biomedical and Health Sciences, Department of Medicine, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Larrubia', 'Affiliation': 'Faculty of Biomedical and Health Sciences, Department of Medicine, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'García', 'Affiliation': 'Faculty of Biomedical and Health Sciences, Department of Medicine, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Zambrana', 'Affiliation': 'Faculty of Biomedical and Health Sciences, Department of Medicine, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Gómez Cerezo', 'Affiliation': 'Faculty of Biomedical and Health Sciences, Department of Medicine, Universidad Europea de Madrid, Madrid, Spain.'}]",Age and ageing,['10.1093/ageing/afaa107']
2467,32542431,"Safety and Efficacy of Ranibizumab and Luseogliflozin Combination Therapy in Patients with Diabetic Macular Edema: Protocol for a Multicenter, Open-Label Randomized Controlled Trial.","INTRODUCTION


Diabetic macular edema (DME) threatens daily life activities such as reading and driving and reduces the patients' quality-of-life. Recently, anti-vascular endothelial growth factor (VEGF) agents have become a first-line therapy in DME. However, therapy with anti-VEGF agents has several problems: repeated invasive injections are required; medical costs are high; and a certain proportion of patients with DME are resistant to treatment with anti-VEGF agents. While sodium-glucose co-transporter 2 (SGLT2) inhibitors have been widely used for the treatment of type 2 diabetes mellitus (T2DM), the effects of a combination therapy with anti-VEGF agent and SGLT2 inhibitor on DME are not yet known.
METHODS


This study enrolls subjects with T2DM and DME, randomizes them into either a study agent treatment group (treated with ranibizumab as anti-VEGF agent and luseogliflozin as SGLT2 inhibitor) or a control group (treated with ranibizumab and glimepiride), and observes the subjects for 52 weeks after initiation of treatment. Planned outcomes: The primary endpoint is intergroup difference in the number of intravitreal anti-VEGF injections to the study eye from baseline to week 48. Secondary and exploratory endpoints include safety and ophthalmologic and internal medical clinical parameters.
REGISTRATION


This study is registered at the University Hospital Medical Information Network Clinical Trial Registry (UMIN000033961) and Japan Registry of Clinical Trials (jRCTs031180210).",2020,The primary endpoint is intergroup difference in the number of intravitreal anti-VEGF injections to the study eye from baseline to week 48.,"['Patients with Diabetic Macular Edema', 'enrolls subjects with T2DM and DME, randomizes them into either a study agent treatment group (treated with']","['sodium-glucose co-transporter\xa02 (SGLT2) inhibitors', 'ranibizumab as anti-VEGF agent and luseogliflozin as SGLT2 inhibitor) or a control group (treated with ranibizumab and glimepiride', 'Ranibizumab and Luseogliflozin Combination Therapy']","['safety and ophthalmologic and internal medical clinical parameters', 'Safety and Efficacy', 'number of intravitreal anti-VEGF injections']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C2933904', 'cui_str': '1,5-anhydro-1-(5-(4-ethoxybenzyl)-2-methoxy-4-methylphenyl)-1-thioglucitol'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]",,0.0283211,The primary endpoint is intergroup difference in the number of intravitreal anti-VEGF injections to the study eye from baseline to week 48.,"[{'ForeName': 'Ryoichi', 'Initials': 'R', 'LastName': 'Ishibashi', 'Affiliation': 'Department of Medicine, Division of Diabetes, Endocrinology and Metabolism, Kimitsu Chuo Hospital, 1010 Sakurai, Kisarazu, Chiba, 292-8535, Japan. ishibashi-cib@umin.net.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Takatsuna', 'Affiliation': 'Department of Ophthalmology, Chiba Rosai Hospital, 2-16 Tatsumidai-Higashi, Ichihara, Chiba, 290-0003, Japan.'}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Koshizaka', 'Affiliation': 'Department of Endocrinology, Hematology and Gerontology, Chiba University Graduate School of Medicine, 1-8-1 Inohana, Chuo-ku, Chiba, Chiba, 260-8677, Japan.'}, {'ForeName': 'Tomoaki', 'Initials': 'T', 'LastName': 'Tatsumi', 'Affiliation': 'Department of Ophthalmology and Vision Science, Chiba University Graduate School of Medicine, 1-8-1 Inohana, Chuo-ku, Chiba, Chiba, 260-8677, Japan.'}, {'ForeName': 'Sho', 'Initials': 'S', 'LastName': 'Takahashi', 'Affiliation': 'Clinical Research Support Center, The Jikei University School of Medicine, 3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo, 105-8461, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Nagashima', 'Affiliation': 'Research Center for Medical and Health Data Science, The Institute of Statistical Mathematics, 10-3 Midori-cho, Tachikawa, Tokyo, 190-8562, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Asaumi', 'Affiliation': 'Department of Ophthalmology, Kimitsu Chuo Hospital, 1010 Sakurai, Kisarazu, Chiba, 292-8535, Japan.'}, {'ForeName': 'Miyuki', 'Initials': 'M', 'LastName': 'Arai', 'Affiliation': 'Department of Ophthalmology, National Hospital Organization Chiba Medical Center, Tsubakimori 4-1-2, Chuo-ku, Chiba, Chiba, 260-8606, Japan.'}, {'ForeName': 'Fumio', 'Initials': 'F', 'LastName': 'Shimada', 'Affiliation': 'Department of Diabetes and Metabolism, National Hospital Organization Chiba Medical Center, Tsubakimori 4-1-2, Chuo-ku, Chiba, Chiba, 260-8606, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Tachibana', 'Affiliation': 'Department of Diabetes, Metabolic Diseases, Endocrinology, Japanese Red Cross Narita Hospital, 90-1, Iida-cho, Narita, Chiba, 286-8523, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Watanabe', 'Affiliation': 'Department of Ophthalmology, Japanese Red Cross Narita Hospital, 90-1, Iida-cho, Narita, Chiba, 286-8523, Japan.'}, {'ForeName': 'Ko', 'Initials': 'K', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Internal Medicine, Chiba Rosai Hospital, Tatsumidai-Higashi 2-16, Ichihara, Chiba, 290-0003, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Hoshino', 'Affiliation': 'Department of Ophthalmology, Chiba Aoba Municipal Hospital, Aoba-cho 1273-2, Chuo-ku, Chiba, Chiba, 260-0852, Japan.'}, {'ForeName': 'Kyohei', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Internal Medicine, Chiba Aoba Municipal Hospital, Aoba-cho 1273-2, Chuo-ku, Chiba, Chiba, 260-0852, Japan.'}, {'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Kubota-Taniai', 'Affiliation': 'Department of Ophthalmology, Chiba Kaihin Municipal Hospital, Isobe 3-31-1, Mihama-ku, Chiba, Chiba, 261-0012, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Mayama', 'Affiliation': 'Department of Internal Medicine, Chiba Kaihin Municipal Hospital, Isobe 3-31-1, Mihama-ku, Chiba, Chiba, 261-0012, Japan.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Ophthalmology and Vision Science, Chiba University Graduate School of Medicine, 1-8-1 Inohana, Chuo-ku, Chiba, Chiba, 260-8677, Japan.'}, {'ForeName': 'Koutaro', 'Initials': 'K', 'LastName': 'Yokote', 'Affiliation': 'Department of Endocrinology, Hematology and Gerontology, Chiba University Graduate School of Medicine, 1-8-1 Inohana, Chuo-ku, Chiba, Chiba, 260-8677, Japan.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00854-6']
2468,32542474,A Resilience Intervention for Adults with Type 2 Diabetes: Proof-of-Concept in Community Health Centers.,"BACKGROUND


Given the psychological stress associated with managing type 2 diabetes (T2D), resilience-promoting interventions may particularly benefit populations experiencing high levels of stress (e.g., racial/ethnic minority and lower-income individuals). Federally qualified Community Health Centers (CHCs) primarily serve these patients and are therefore ideal settings for resilience-promoting T2D programs. This proof-of-concept study tested the Resilience-Based Diabetes Self-Management Education (RB-DSME) intervention within a CHC.
METHOD


Thirty-five patients with T2D (M age = 51 years, 71% female, 60% Hispanic, 69% annual household income < $20,000) at two clinics within the CHC completed the RB-DSME, consisting of eight bi-weekly classes and two monthly support groups. In this treatment-only design, resilience resources, self-management behaviors, and physical and mental health outcomes were measured at baseline and 6 months.
RESULTS


Attendance (M = 7.66/10) and program satisfaction (M = 6.79/7) were high. Participants improved adaption to stress (d = .67), adaptive coping (d = .60), diabetes empowerment (d = .57), and finding positive meaning (d = .85). Large increases in self-management behaviors (d = 1.38) and number of steps (d = 1.11) were also observed. Participants lowered A1C from baseline (M = 8.79%) to 6 months (M = 8.11%; d = .50), along with diabetes distress (d = 1.31), depressive symptoms (d = .80), and general perceived stress (d = .55).
CONCLUSION


This study demonstrated the ability of the RB-DSME to improve resilience resources, self-management behaviors, and health outcomes among racial/ethnic minority and lower-income patients with T2D at clinics within a CHC. A larger, randomized trial should more rigorously test the RB-DSME in this clinical setting.",2020,"Participants improved adaption to stress (d = .67), adaptive coping (d = .60), diabetes empowerment (d = .57), and finding positive meaning (d = .85).","['Adults with Type 2 Diabetes', 'racial/ethnic minority and lower-income patients with T2D at clinics within a CHC', 'Thirty-five patients with T2D (M age\u2009=\u200951\xa0years, 71% female, 60% Hispanic, 69% annual household income <\u2009$20,000) at two clinics within the CHC completed the RB-DSME, consisting of eight bi-weekly classes and two monthly support groups']","['RB-DSME', 'Resilience-Based Diabetes Self-Management Education (RB-DSME) intervention']","['adaption to stress', 'adaptive coping', 'resilience resources, self-management behaviors, and physical and mental health outcomes', 'diabetes distress', 'diabetes empowerment', 'self-management behaviors', 'depressive symptoms', 'program satisfaction']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1861453', 'cui_str': 'Pseudohyperkalemia Cardiff'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0557163', 'cui_str': 'Household income'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}]","[{'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",35.0,0.0303655,"Participants improved adaption to stress (d = .67), adaptive coping (d = .60), diabetes empowerment (d = .57), and finding positive meaning (d = .85).","[{'ForeName': 'Susan K', 'Initials': 'SK', 'LastName': 'Dubois', 'Affiliation': 'Department of Internal Medicine, Dell Medical School, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'H Matthew', 'Initials': 'HM', 'LastName': 'Lehrer', 'Affiliation': 'Department of Kinesiology and Health Education, The University of Texas at Austin, 2109 San Jacinto Blvd, Stop D3700, Austin, TX, 78712, USA.'}, {'ForeName': 'Erum Z', 'Initials': 'EZ', 'LastName': 'Whyne', 'Affiliation': 'Department of Kinesiology and Health Education, The University of Texas at Austin, 2109 San Jacinto Blvd, Stop D3700, Austin, TX, 78712, USA.'}, {'ForeName': 'Mary A', 'Initials': 'MA', 'LastName': 'Steinhardt', 'Affiliation': 'Department of Kinesiology and Health Education, The University of Texas at Austin, 2109 San Jacinto Blvd, Stop D3700, Austin, TX, 78712, USA. msteinhardt@austin.utexas.edu.'}]",International journal of behavioral medicine,['10.1007/s12529-020-09894-5']
2469,32542515,Task-related functional magnetic resonance imaging-based neuronavigation for the treatment of depression by individualized repetitive transcranial magnetic stimulation of the visual cortex.,"To determine whether repetitive transcranial magnetic stimulation (rTMS) of the visual cortex (VC) provides effective and well-tolerated treatment and whether magnetic resonance imaging (MRI) measures functional change of the VC as a biomarker of therapeutic effect in major depressive disorder (MDD), we performed a sham-controlled, double-blind, randomized, three-arm VC rTMS treatment study in 74 MDD patients. Neuronavigated rTMS (10 Hz, 90% of resting motor threshold, 1,600 pulses over 20 min twice per day) was performed over the VC for five days. Clinical outcome was measured by Hamilton Depression Rating Scale (HAMD-24) at days 0, 1, 3, 5 and after terminating rTMS, with follow-up at four weeks. MRI was measured at days 0 and 5. The individualized group exhibited the greatest change in HAMD-24 scores after VC rTMS for 5 days (F=5.53, P=0.005), which were maintained during follow-up period (F=4.22, P=0.016). All patients reported good tolerance. Changes in VC task-related functional MRI correlated with symptomatic reduction in the individualized group. Treatment reduced the initially abnormal increase in resting state functional connectivity from the VC to the pre/subgenual anterior cingulate cortex at day 5, especially in the individualized group. We demonstrated therapeutic potential and good tolerance of VC rTMS in MDD patients, indicated by biomarkers of fMRI measurement.",2020,"Treatment reduced the initially abnormal increase in resting state functional connectivity from the VC to the pre/subgenual anterior cingulate cortex at day 5, especially in the individualized group.","['major depressive disorder (MDD', '74 MDD patients']","['Neuronavigated rTMS', 'Task-related functional magnetic resonance imaging-based neuronavigation', 'magnetic resonance imaging (MRI', 'repetitive transcranial magnetic stimulation (rTMS) of the visual cortex (VC']","['good tolerance', 'resting state functional connectivity', 'VC task-related functional MRI', 'HAMD-24 scores', 'MRI', 'Hamilton Depression Rating Scale (HAMD-24']","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1136207', 'cui_str': 'Frameless Stereotaxy'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0042817', 'cui_str': 'Visual Cortex'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0042817', 'cui_str': 'Visual Cortex'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}]",74.0,0.0373343,"Treatment reduced the initially abnormal increase in resting state functional connectivity from the VC to the pre/subgenual anterior cingulate cortex at day 5, especially in the individualized group.","[{'ForeName': 'Zhijun', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology of Affiliated Zhongda Hospital, Institute of Neuropsychiatry and Medical School of Southeast University, Nanjing, 210009, China. janemengzhang@vip.163.com.'}, {'ForeName': 'Hongxing', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychology of Xinxiang Medical University, Xinxiang, 453003, China.'}, {'ForeName': 'Chun-Ming', 'Initials': 'CM', 'LastName': 'Xie', 'Affiliation': 'Department of Neurology of Affiliated Zhongda Hospital, Institute of Neuropsychiatry and Medical School of Southeast University, Nanjing, 210009, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychology of Xinxiang Medical University, Xinxiang, 453003, China.'}, {'ForeName': 'Yachen', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Neurology of Affiliated Zhongda Hospital, Institute of Neuropsychiatry and Medical School of Southeast University, Nanjing, 210009, China.'}, {'ForeName': 'Ruize', 'Initials': 'R', 'LastName': 'Song', 'Affiliation': 'Department of Neurology of Affiliated Zhongda Hospital, Institute of Neuropsychiatry and Medical School of Southeast University, Nanjing, 210009, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'Department of Neurology of Affiliated Zhongda Hospital, Institute of Neuropsychiatry and Medical School of Southeast University, Nanjing, 210009, China.'}, {'ForeName': 'Haisan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Second Affiliated Hospital of Xinxiang Medical University, Xinxiang, 453002, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Department of Psychology of Xinxiang Medical University, Xinxiang, 453003, China.'}, {'ForeName': 'Bi', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Psychology of Xinxiang Medical University, Xinxiang, 453003, China.'}, {'ForeName': 'Yongfeng', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Second Affiliated Hospital of Xinxiang Medical University, Xinxiang, 453002, China.'}, {'ForeName': 'Xianrui', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Psychology of Xinxiang Medical University, Xinxiang, 453003, China.'}, {'ForeName': 'Jianli', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of Psychology of Xinxiang Medical University, Xinxiang, 453003, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Deaprtment of Biostatistics, School of Public Health, Nanjing Medical University, Nanjing, 211166, China.'}, {'ForeName': 'Ti-Fei', 'Initials': 'TF', 'LastName': 'Yuan', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai, 200030, China. ytf0707@126.com.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Northoff', 'Affiliation': 'Department of Neurology of Affiliated Zhongda Hospital, Institute of Neuropsychiatry and Medical School of Southeast University, Nanjing, 210009, China. georg.northoff@theroyal.ca.'}]",Science China. Life sciences,['10.1007/s11427-020-1730-5']
2470,32542578,Does Organizing Mentor-Mentee Matches into Small Groups Enhance Treatment Effects in a Site-Based Mentoring Program for Adolescents? Results of a Randomized Controlled Trial.,"Formal youth mentoring is an effective intervention strategy for healthy development during adolescence. Modest and varied effects across programs, however, demonstrate a need to identify factors that can reliably improve outcomes for mentored youth. The purpose of this randomized controlled trial was to test the relative impact of embedding mentee-mentor matches in small groups on youth outcomes and to examine whether this effect was mediated by the quality of the program setting and mentoring relationship quality. Participants included 676 adolescents (M age  = 14.21, range = 11-18; 41.6% female) enrolled in Campus Connections, a site-based youth mentoring program. Most measured outcomes in both conditions (i.e., mentoring groups and a control condition in which pairs were not embedded in a group) were significantly better at post-intervention as compared to pre-intervention. The hypothesis that mentoring groups would have stronger impact, however, was not supported. The results imply that organizing mentor-mentee matches in small groups offer no advantage or disadvantage and that youth may be able to garner benefit from both structures.",2020,"The hypothesis that mentoring groups would have stronger impact, however, was not supported.","['Participants included 676 adolescents (M age \u2009=\u200914.21, range\u2009=\u200911-18; 41.6% female) enrolled in Campus Connections, a site-based youth mentoring program', 'healthy development during adolescence']",[],[],"[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",[],[],676.0,0.0674145,"The hypothesis that mentoring groups would have stronger impact, however, was not supported.","[{'ForeName': 'Shelley A', 'Initials': 'SA', 'LastName': 'Haddock', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA. shelley.haddock@colostate.edu.'}, {'ForeName': 'Lindsey M', 'Initials': 'LM', 'LastName': 'Weiler', 'Affiliation': 'University of Minnesota, St. Paul, MN, 55108, USA.'}, {'ForeName': 'Hyanghee', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Kimberly L', 'Initials': 'KL', 'LastName': 'Henry', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lucas-Thompson', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Toni S', 'Initials': 'TS', 'LastName': 'Zimmerman', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Krafchick', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Gereon F', 'Initials': 'GF', 'LastName': 'Fredrickson', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Yetz', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Lise M', 'Initials': 'LM', 'LastName': 'Youngblade', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}]",Journal of youth and adolescence,['10.1007/s10964-020-01267-1']
2471,32542627,Vitamin D in Type 2 Diabetes: Genetic Susceptibility and the Response to Supplementation.,"Variants of vitamin D metabolism-genes may predispose to type 2 diabetes (T2D). This study investigated the impact of these variants on disease susceptibility, Vitamin D, parathyroid hormone, C-peptide and HbA1c levels before and after cholecalciferol supplementation in patients with T2D.Twelve polymorphisms within CYP2R1, CYP27B1, DBP, VDR and CYP24A1 were genotyped in 553 T2D patients and 916 controls. In addition 65 patients receiving either cholecalciferol or placebo were analyzed during 6 months intervention and 6 months follow-up.T2D risk alleles are VDR rs7975232 ""G"" (p c =0.031), rs1544410 ""G"" (p c =0.027) and CYP2R1 rs10741657 ""A"" (p c =0.016). Patients with genotypes CYP27B1 rs10877012 ""CC"" (p c =4x10 -5 ), DBP rs7041 ""GG"" (p c =0.003), rs4588 ""CC"" (p c  = 3x10 -4 ), CYP24A1 rs2585426 ""CG"" (p c =0.006) and rs2248137 ""CG"" (p c =0.001) showed lower 25(OH)D3 and DBP rs4588 ""CC"" lower 1,25(OH)2D3 levels (p c =0.005). Whereas DBP rs4588 ""CC"" (p c =0.009), CYP27B1 rs10877012 ""AC"" (p c =0.059), VDR rs7975323 ""AG"" (p c =0.033) and rs1544410 ""GG"" (p c =0.013) are associated with higher 25(OH)D3 levels at 6 months' follow-up. Significant PTH suppression was detected for CYP2R1 ""AG"" (p c =0.002), DBP rs4588 ""CC"" (p c <0.001), VDR rs110735810 ""CT"" (p c <0.001) and CYP24A1 rs2248137 ""GG"" (p c =0.021).Genetic variants of the vitamin D system predispose to type 2 diabetes and regulate - partially - vitamin D metabolism, concentrations and the vitamin D status. Vitamin D insufficiency is a T2D risk factor. The response to cholecalciferol supplementation can be measured as 25(OH)D3 increment and PTH suppression. This process is regulated by genes of the vitamin D system conferring modest T2D risk.",2020,"Significant PTH suppression was detected for CYP2R1 ""AG"" (p c =0.002), DBP rs4588 ""CC"" (p c <0.001), VDR rs110735810 ""CT"" (p c <0.001) and CYP24A1 rs2248137 ""GG"" (p c =0.021).Genetic variants of the vitamin D system predispose to type 2 diabetes and regulate - partially - vitamin D metabolism, concentrations and the vitamin D status.","['Type 2 Diabetes', 'Patients with genotypes', 'patients with T2D.Twelve polymorphisms within CYP2R1, CYP27B1, DBP, VDR and CYP24A1 were genotyped in 553 T2D patients and 916 controls', '65 patients receiving either']","['cholecalciferol supplementation', 'cholecalciferol or placebo', 'Vitamin D']","['DBP rs4588 ""CC', '25(OH)D3 levels', 'VDR rs7975323 ""AG', 'CYP2R1 ""AG', '25(OH)D3 and DBP rs4588 ""CC"" lower 1,25(OH)2D3 levels', '25(OH)D3 increment and PTH suppression', 'CYP27B1 rs10877012 ""AC', 'disease susceptibility, Vitamin D, parathyroid hormone, C-peptide and HbA1c levels', 'VDR rs110735810 ""CT', 'Significant PTH suppression']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C1827418', 'cui_str': 'Cytochrome p450 CYP2R1 enzyme'}, {'cui': 'C0000340', 'cui_str': 'Calcidiol 1-monooxygenase'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C3657722', 'cui_str': 'VDR protein, human'}, {'cui': 'C0283470', 'cui_str': '1 alpha,25-Dihydroxycholecalciferol-24-Hydroxylase'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3657722', 'cui_str': 'VDR protein, human'}, {'cui': 'C1827418', 'cui_str': 'Cytochrome p450 CYP2R1 enzyme'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0000340', 'cui_str': 'Calcidiol 1-monooxygenase'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]",,0.0456524,"Significant PTH suppression was detected for CYP2R1 ""AG"" (p c =0.002), DBP rs4588 ""CC"" (p c <0.001), VDR rs110735810 ""CT"" (p c <0.001) and CYP24A1 rs2248137 ""GG"" (p c =0.021).Genetic variants of the vitamin D system predispose to type 2 diabetes and regulate - partially - vitamin D metabolism, concentrations and the vitamin D status.","[{'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Klahold', 'Affiliation': 'Department of Internal Medicine I, Division of Endocrinology, Diabetes and Metabolism, Goethe-University Hospital, Frankfurt/Main, Germany.'}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Penna-Martinez', 'Affiliation': 'Department of Internal Medicine I, Division of Endocrinology, Diabetes and Metabolism, Goethe-University Hospital, Frankfurt/Main, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Bruns', 'Affiliation': 'Department of Internal Medicine I, Division of Endocrinology, Diabetes and Metabolism, Goethe-University Hospital, Frankfurt/Main, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Seidl', 'Affiliation': 'German Red Cross Blood Donor Service, Institute for Transfusion Medicine and Immunohaematology, Frankfurt/Main, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Wicker', 'Affiliation': 'Occupational Health Service, Goethe-University Hospital, Frankfurt/Main, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Badenhoop', 'Affiliation': 'Department of Internal Medicine I, Division of Endocrinology, Diabetes and Metabolism, Goethe-University Hospital, Frankfurt/Main, Germany.'}]",Hormone and metabolic research = Hormon- und Stoffwechselforschung = Hormones et metabolisme,['10.1055/a-1157-0026']
2472,32546129,A psychological intervention for suicide applied to non-affective psychosis: the CARMS (Cognitive AppRoaches to coMbatting Suicidality) randomised controlled trial protocol.,"BACKGROUND


Suicide is a leading cause of death globally. Suicide deaths are elevated in those experiencing severe mental health problems, including schizophrenia. Psychological talking therapies are a potentially effective means of alleviating suicidal thoughts, plans, and attempts. However, talking therapies need to i) focus on suicidal experiences directly and explicitly, and ii) be based on testable psychological mechanisms. The Cognitive AppRoaches to coMbatting Suicidality (CARMS) project is a Randomised Controlled Trial (RCT) which aims to investigate both the efficacy and the underlying mechanisms of a psychological talking therapy for people who have been recently suicidal and have non-affective psychosis.
METHODS


The CARMS trial is a two-armed single-blind RCT comparing a psychological talking therapy (Cognitive Behavioural Suicide Prevention for psychosis [CBSPp]) plus Treatment As Usual (TAU) with TAU alone. There are primary and secondary suicidality outcome variables, plus mechanistic, clinical, and health economic outcomes measured over time. The primary outcome is a measure of suicidal ideation at 6 months after baseline. The target sample size is 250, with approximately 125 randomised to each arm of the trial, and an assumption of up to 25% attrition. Hence, the overall recruitment target is up to 333. An intention to treat analysis will be used with primary stratification based on National Health Service (NHS) recruitment site and antidepressant prescription medication. Recruitment will be from NHS mental health services in the North West of England, UK. Participants must be 18 or over; be under the care of mental health services; have mental health problems which meet ICD-10 non-affective psychosis criteria; and have experienced self-reported suicidal thoughts, plans, and/or attempts in the 3 months prior to recruitment. Nested qualitative work will investigate the pathways to suicidality, experiences of the therapy, and identify potential implementation challenges beyond a trial setting as perceived by numerous stake-holders.
DISCUSSION


This trial has important implications for countering suicidal experiences for people with psychosis. It will provide definitive evidence about the efficacy of the CBSPp therapy; the psychological mechanisms which lead to suicidal experiences; and provide an understanding of what is required to implement the intervention into services should it be efficacious.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT03114917), 14th April 2017. ISRCTN (reference ISRCTN17776666 https://doi.org/10.1186/ISRCTN17776666); 5th June 2017). Registration was recorded prior to participant recruitment commencing.",2020,The CARMS trial is a two-armed single-blind RCT comparing a psychological talking therapy (Cognitive Behavioural Suicide Prevention for psychosis [CBSPp]) plus Treatment As Usual (TAU) with TAU alone.,"['Participants must be 18 or over; be under the care of mental health services; have mental health problems which meet ICD-10 non-affective psychosis criteria; and have experienced self-reported suicidal thoughts, plans, and/or attempts in the 3 months prior to recruitment', 'people who have been recently suicidal and have non-affective psychosis', 'suicide applied to non-affective psychosis', 'people with psychosis']","['psychological intervention', 'psychological talking therapy', 'psychological talking therapy (Cognitive Behavioural Suicide Prevention', 'Psychological talking therapies']","['suicidal ideation', 'plus mechanistic, clinical, and health economic outcomes', 'Suicide deaths']","[{'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C0001723', 'cui_str': 'Affective psychosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0204732', 'cui_str': 'Suicide prevention'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0013560', 'cui_str': 'Medical Economics'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.231865,The CARMS trial is a two-armed single-blind RCT comparing a psychological talking therapy (Cognitive Behavioural Suicide Prevention for psychosis [CBSPp]) plus Treatment As Usual (TAU) with TAU alone.,"[{'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Gooding', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Manchester Academic Health Sciences Centre, University of Manchester, Coupland Building 1, Oxford Road, Manchester, M13 9PL, UK. patricia.gooding@manchester.ac.uk.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pratt', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Manchester Academic Health Sciences Centre, University of Manchester, Coupland Building 1, Oxford Road, Manchester, M13 9PL, UK.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Awenat', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Manchester Academic Health Sciences Centre, University of Manchester, Coupland Building 1, Oxford Road, Manchester, M13 9PL, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Drake', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Manchester Academic Health Sciences Centre, University of Manchester, Coupland Building 1, Oxford Road, Manchester, M13 9PL, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Elliott', 'Affiliation': 'Manchester Centre for Health Economics, School of Health Sciences, Manchester Academic Health Sciences Centre, University of Manchester, Manchester, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Emsley', 'Affiliation': 'Institute of Psychiatry, Psychology & Neuroscience, Kings College London, London, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Huggett', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Manchester Academic Health Sciences Centre, University of Manchester, Coupland Building 1, Oxford Road, Manchester, M13 9PL, UK.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Jones', 'Affiliation': 'Lancashire Care NHS Foundation Trust, Lancashire, UK.'}, {'ForeName': 'Navneet', 'Initials': 'N', 'LastName': 'Kapur', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Manchester Academic Health Sciences Centre, University of Manchester, Coupland Building 1, Oxford Road, Manchester, M13 9PL, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Lobban', 'Affiliation': 'Lancashire Care NHS Foundation Trust, Lancashire, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Manchester Academic Health Sciences Centre, University of Manchester, Coupland Building 1, Oxford Road, Manchester, M13 9PL, UK.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Haddock', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Manchester Academic Health Sciences Centre, University of Manchester, Coupland Building 1, Oxford Road, Manchester, M13 9PL, UK.'}]",BMC psychiatry,['10.1186/s12888-020-02697-8']
2473,32546139,Using mind control to modify cue-reactivity in AUD: the impact of mindfulness-based relapse prevention on real-time fMRI neurofeedback to modify cue-reactivity in alcohol use disorder: a randomized controlled trial.,"BACKGROUND


Alcohol Use Disorder is a severe mental disorder affecting the individuals concerned, their family and friends and society as a whole. Despite its high prevalence, novel treatment options remain rather limited. Two innovative interventions used for treating severe disorders are the use of real-time functional magnetic resonance imaging neurofeedback that targets brain regions related to the disorder, and mindfulness-based treatments. In the context of the TRR SFB 265 C04 ""Mindfulness-based relapse prevention as an addition to rtfMRI NFB intervention for patients with Alcohol Use Disorder (MiND)"" study, both interventions will be combined to a state-of-the art intervention that will use mindfulness-based relapse prevention to improve the efficacy of a real-time neurofeedback intervention targeting the ventral striatum, which is a brain region centrally involved in cue-reactivity to alcohol-related stimuli.
METHODS/DESIGN


After inclusion, N = 88 patients will be randomly assigned to one of four groups. Two of those groups will receive mindfulness-based relapse prevention. All groups will receive two fMRI sessions and three real-time neurofeedback sessions in a double-blind manner and will regulate either the ventral striatum or the auditory cortex as a control region. Two groups will additionally receive five sessions of mindfulness-based relapse prevention prior to the neurofeedback intervention. After the last fMRI session, the participants will be followed-up monthly for a period of 3 months for an assessment of the relapse rate and clinical effects of the intervention.
DISCUSSION


The results of this study will give further insights into the efficacy of real-time functional magnetic resonance imaging neurofeedback interventions for the treatment of Alcohol Use Disorder. Additionally, the study will provide further insight on neurobiological changes in the brain caused by the neurofeedback intervention as well as by the mindfulness-based relapse prevention. The outcome might be useful to develop new treatment approaches targeting mechanisms of Alcohol Use Disorder with the goal to reduce relapse rates after discharge from the hospital.
TRIAL REGISTRATION


This trial is pre-registered at clinicaltrials.gov (trial identifier: NCT04366505; WHO Universal Trial Number (UTN): U1111-1250-2964). Registered 30 March 2020, published 29 April 2020.",2020,"Two innovative interventions used for treating severe disorders are the use of real-time functional magnetic resonance imaging neurofeedback that targets brain regions related to the disorder, and mindfulness-based treatments.","['WHO Universal Trial Number (UTN', 'alcohol use disorder']","['mindfulness-based relapse prevention prior to the neurofeedback intervention', 'rtfMRI NFB intervention']",[],"[{'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0679867', 'cui_str': 'Relapse prevention'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],88.0,0.0585032,"Two innovative interventions used for treating severe disorders are the use of real-time functional magnetic resonance imaging neurofeedback that targets brain regions related to the disorder, and mindfulness-based treatments.","[{'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Weiss', 'Affiliation': 'Department of Clinical Psychology, Central Institute of Mental Health (ZI), Heidelberg University/Medical Faculty Mannheim, 68159, Mannheim, Germany. franziska.weiss@zi-mannheim.de.'}, {'ForeName': 'Acelya', 'Initials': 'A', 'LastName': 'Aslan', 'Affiliation': 'Department of Addiction Behavior and Addiction Medicine, Central Institute of Mental Health, Heidelberg University/Medical Faculty Mannheim, Mannheim, Germany.'}, {'ForeName': 'Jingying', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Clinical Psychology, Central Institute of Mental Health (ZI), Heidelberg University/Medical Faculty Mannheim, 68159, Mannheim, Germany.'}, {'ForeName': 'Martin Fungisai', 'Initials': 'MF', 'LastName': 'Gerchen', 'Affiliation': 'Department of Clinical Psychology, Central Institute of Mental Health (ZI), Heidelberg University/Medical Faculty Mannheim, 68159, Mannheim, Germany.'}, {'ForeName': 'Falk', 'Initials': 'F', 'LastName': 'Kiefer', 'Affiliation': 'Department of Addiction Behavior and Addiction Medicine, Central Institute of Mental Health, Heidelberg University/Medical Faculty Mannheim, Mannheim, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kirsch', 'Affiliation': 'Department of Clinical Psychology, Central Institute of Mental Health (ZI), Heidelberg University/Medical Faculty Mannheim, 68159, Mannheim, Germany.'}]",BMC psychiatry,['10.1186/s12888-020-02717-7']
2474,32546148,Effect of assertive case management intervention on suicide attempters with comorbid Axis I and II psychiatric diagnoses: secondary analysis of a randomised controlled trial.,"BACKGROUND


Most suicide attempters suffer from psychiatric disorders, which are often comorbid with personality disorders. The effects of intervention on patients who have attempted suicide with comorbid Axis I and II diagnoses have not been fully elucidated. We evaluated whether assertive case management can reduce the repetition of suicidal behaviours in patients who had attempted suicide with comorbid Axis I and II diagnoses.
METHODS


This study was a secondary analysis of a randomised controlled trial investigating whether assertive case management could reduce the repetition of suicide attempts, compared with enhanced usual care. Subjects were divided into those who had comorbid Axis I and II diagnoses (Axis I + II group), and those who had an Axis I diagnosis without Axis II comorbidity (Axis I group). Outcome measures were compared between patients receiving a case management intervention and patients receiving enhanced usual care, as allocated. The primary outcome measure was the incidence proportion of the first episode of recurrent suicidal behaviour at 6 months after randomisation. We calculated risk ratios (RR) with 95% confidence intervals (CI) at 6 months and 12 months after randomisation of patients in the Axis I and Axis I + II groups.
RESULTS


Of 914 enrolled patients, 120 (13.1%) were in the Axis I + II group, and 794 (86.9%) were in the Axis I group. Assertive case management was significantly effective for the Axis I group on the primary outcome at 6 months (risk ratio [RR] 0.51, 95% confidence intervals [CI] 0.31 to 0.84). The RR of the Axis I + II group was 0.44 (95% CI 0.14 to 1.40).
CONCLUSIONS


Assertive case management not only had an effect on patients who had attempted suicide with only Axis I disorders but may also have a similar effect on patients with comorbid Axis I and II disorders.",2020,"This study was a secondary analysis of a randomised controlled trial investigating whether assertive case management could reduce the repetition of suicide attempts, compared with enhanced usual care.","['suicide attempters with comorbid Axis I and II psychiatric diagnoses', 'patients who had attempted suicide with comorbid Axis I and II diagnoses', 'Subjects were divided into those who had comorbid Axis I and II diagnoses (Axis I\u2009+\u2009II group), and those who had an Axis I diagnosis without Axis II comorbidity (Axis I group', 'patients who have attempted suicide with comorbid Axis I and II diagnoses']",['assertive case management intervention'],"['repetition of suicide attempts', 'incidence proportion of the first episode of recurrent suicidal behaviour', 'repetition of suicidal behaviours', 'calculated risk ratios (RR']","[{'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0376338', 'cui_str': 'Psychiatric Diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0270287', 'cui_str': 'Axis I diagnosis'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0085971', 'cui_str': 'Case management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",914.0,0.0613649,"This study was a secondary analysis of a randomised controlled trial investigating whether assertive case management could reduce the repetition of suicide attempts, compared with enhanced usual care.","[{'ForeName': 'Kazunobu', 'Initials': 'K', 'LastName': 'Norimoto', 'Affiliation': 'Department of Psychiatry, Nara Medical University, 840 Shijo-Cho Kashihara, Nara, 634-8521, Japan.'}, {'ForeName': 'Katsumi', 'Initials': 'K', 'LastName': 'Ikeshita', 'Affiliation': 'Department of Psychiatry, Nara Medical University, 840 Shijo-Cho Kashihara, Nara, 634-8521, Japan.'}, {'ForeName': 'Toshifumi', 'Initials': 'T', 'LastName': 'Kishimoto', 'Affiliation': 'Department of Psychiatry, Nara Medical University, 840 Shijo-Cho Kashihara, Nara, 634-8521, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Okuchi', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Nara Medical University, 840 Shijo-Cho Kashihara, Nara, 634-8521, Japan.'}, {'ForeName': 'Naohiro', 'Initials': 'N', 'LastName': 'Yonemoto', 'Affiliation': 'Department of Neuropsychopharmacology, National Center of Neurology and Psychiatry, 4-1-1 Ogawa-Higasi, Kodaira, Tokyo, 187-8551, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Sugimoto', 'Affiliation': 'Department of Psycho-oncology, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Prefecture, Nagaizumi, 411-8777, Japan.'}, {'ForeName': 'Fuminori', 'Initials': 'F', 'LastName': 'Chida', 'Affiliation': 'Department of Neuropsychiatry, Iwate Medical University, 1-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate-Prefecture, 028-3694, Japan.'}, {'ForeName': 'Shigero', 'Initials': 'S', 'LastName': 'Shimoda', 'Affiliation': 'Department of Psychiatry, Nara Medical University, 840 Shijo-Cho Kashihara, Nara, 634-8521, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Hirayasu', 'Affiliation': 'Hirayasu Hospital, 346 Kyozuka, Urasoe, Okinawa, 901-2111, Japan.'}, {'ForeName': 'Chiaki', 'Initials': 'C', 'LastName': 'Kawanishi', 'Affiliation': 'Department of Neuropsychiatry, Sapporo Medical University Graduate School of Medicine, 291 S-1, W-16, Chuo-ku, Sapporo, 060-8543, Japan. chiaki.kawanishi@gmail.com.'}]",BMC psychiatry,['10.1186/s12888-020-02723-9']
2475,32546198,Impact of routine assessment of health-related quality of life coupled with therapeutic information on compliance with endocrine therapy in patients with non-metastatic breast cancer: protocol for a randomized controlled trial.,"BACKGROUND


Despite its proven efficacy in reducing recurrence and improving survival, adherence to endocrine therapy (ET) is suboptimal in women with breast cancer (BC). Health-related quality of life (HRQoL) in BC has been widely studied and many positive effects have been highlighted. Recently, a link between HRQoL and compliance with ET has been suggested, which would suggest a potential role for HRQoL assessment in improving compliance with ET. With the advent of digital technologies, electronic collection of HRQoL on a tablet is now possible. Thus, we hypothesize that systematic HRQoL assessment (using a tablet, prior to each consultation, with presentation of scores to clinicians) coupled with therapeutic information could have an impact on 12-month compliance with ET in patients with non-metastatic BC.
METHODS


In this study, we will include 342 women with non-metastatic hormone receptor-positive BC with an indication for treatment with ET. Patients will be randomly assigned 1:1 by minimization and stratified by age, stage, type of ET prescribed, and presence of comorbidities (or not) in two arms. The intervention will consist of numerical HRQoL assessment using the CHES (Computer-based Health Evaluation System) software before each consultation (with delivery of scores to clinicians) coupled with therapeutic information. Therapeutic information will consist of three workshops related to understanding the prescription, nutrition, and fatigue. A reminder letter will be sent to patients every month. Patients in the control group will follow standard care. HRQoL will be assessed using a classic ""paper-pencil"" collection at baseline in both arms to ensure comparability between arms and at 12 months. The primary endpoint is 12-month compliance with ET. Patient satisfaction with care and the clinicians' perception of the usefulness of routine HRQoL assessment will also be assessed.
DISCUSSION


This study will allow clinicians to identify and better understand the areas in which patients who receive ET have difficulties and thus it will assist clinicians with patient management. Systematic evaluation of HRQoL could provide an additional endpoint for measuring patients' health status and treatment-related symptoms, including ET. If the results of this study are positive, this intervention could be proposed as an integral part of daily clinical practice in patients who receive ET.
TRIAL REGISTRATION


ClinicalTrials.govNCT04176809. Registered Nov. 25, 2019.",2020,The intervention will consist of numerical HRQoL assessment using the CHES (Computer-based Health Evaluation System) software before each consultation (with delivery of scores to clinicians) coupled with therapeutic information.,"['patients who receive ET', 'patients with non-metastatic breast cancer', '342 women with non-metastatic hormone receptor-positive BC with an indication for treatment with ET', 'patients with non-metastatic BC', 'women with breast cancer (BC']","['endocrine therapy', 'HRQoL', 'endocrine therapy (ET']",['12-month compliance with ET'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C5191280', 'cui_str': '342'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]",342.0,0.0737719,The intervention will consist of numerical HRQoL assessment using the CHES (Computer-based Health Evaluation System) software before each consultation (with delivery of scores to clinicians) coupled with therapeutic information.,"[{'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Mamguem Kamga', 'Affiliation': 'Epidemiology and Quality of Life Research Unit, INSERM U1231, Georges Francois Leclerc Centre - UNICANCER, 1 rue du Professeur Marion, Dijon Cedex, 21000, France.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Di Martino', 'Affiliation': 'Georges François Leclerc Centre - UNICANCER, 1 rue du Professeur Marion, Dijon, 21000, France.'}, {'ForeName': 'Amelie', 'Initials': 'A', 'LastName': 'Anota', 'Affiliation': 'Methodological and Quality of Life Unit in Oncology, University Hospital Of Besançon, 3 Boulevard Alexandre Fleming, Besançon, 25000, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Paget-Bailly', 'Affiliation': 'Methodological and Quality of Life Unit in Oncology, University Hospital Of Besançon, 3 Boulevard Alexandre Fleming, Besançon, 25000, France.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Coutant', 'Affiliation': 'Surgery Department, Georges François Leclerc Centre - UNICANCER, 1 rue du Professeur Marion, Dijon, 21000, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Arveux', 'Affiliation': 'Epidemiology and Quality of Life Research Unit, INSERM U1231, Georges Francois Leclerc Centre - UNICANCER, 1 rue du Professeur Marion, Dijon Cedex, 21000, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Desmoulins', 'Affiliation': 'Medical Oncology Unit, Centre Georges-François Leclerc Centre - UNICANCER, 1 rue du Professeur Marion, Dijon, 21000, France.'}, {'ForeName': 'Tienhan Sandrine', 'Initials': 'TS', 'LastName': 'Dabakuyo-Yonli', 'Affiliation': 'Epidemiology and Quality of Life Research Unit, INSERM U1231, Georges Francois Leclerc Centre - UNICANCER, 1 rue du Professeur Marion, Dijon Cedex, 21000, France. sdabakuyo@cgfl.fr.'}]",Trials,['10.1186/s13063-020-04397-w']
2476,32546199,Non-specific effects of rabies vaccine on the incidence of common infectious disease episodes: study protocol for a randomized controlled trial.,"BACKGROUND


Vaccines may cause non-specific effects (NSEs) on morbidity and mortality through immune-mediated mechanisms that are not explained by the prevention of the targeted disease. Much of the evidence for NSEs comes from observational studies with a high risk of bias, and there is a clear need for new data from randomized controlled trials. Recently, it was proposed that rabies vaccine has protective NSEs in people and in animals. The aim of the proposed study is to determine whether rabies vaccine reduces the incidence rate of episodes of common infectious disease syndromes in a population of veterinary students on the island of St. Kitts.
METHODS


The trial design is a single-site, two-arm, parallel-group, participant-blinded, randomized, placebo-controlled, two-sided comparative study, with an internal pilot study for blinded sample size re-estimation. Allocation to study arm is by block randomization stratified by sex within cohort with a 1:1 allocation ratio. The primary study outcome is the number of new weekly episodes of common infectious diseases including respiratory, diarrheal and febrile illnesses. A vaccine immunogenicity ancillary study is planned.
DISCUSSION


Demonstration of a non-specific protective effect of rabies vaccine against unrelated respiratory, gastrointestinal and febrile illnesses would provide supportive evidence for the design of similar studies in children in populations with a high burden of these illnesses.
TRIAL REGISTRATION


ClinicalTrials.gov, ID: NCT03656198. Registered on 24 August 2018.",2020,"DISCUSSION


Demonstration of a non-specific protective effect of rabies vaccine against unrelated respiratory, gastrointestinal and febrile illnesses would provide supportive evidence for the design of similar studies in children in populations with a high burden of these illnesses.
","['a population of veterinary students on the island of St. Kitts', 'children in populations with a high burden of these illnesses']","['rabies vaccine', 'placebo']","['number of new weekly episodes of common infectious diseases including respiratory, diarrheal and febrile illnesses']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0042614', 'cui_str': 'veterinary'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0022130', 'cui_str': 'Island'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]","[{'cui': 'C0034496', 'cui_str': 'Rabies vaccine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0743841', 'cui_str': 'Disorder characterized by fever'}]",,0.66495,"DISCUSSION


Demonstration of a non-specific protective effect of rabies vaccine against unrelated respiratory, gastrointestinal and febrile illnesses would provide supportive evidence for the design of similar studies in children in populations with a high burden of these illnesses.
","[{'ForeName': 'Darryn', 'Initials': 'D', 'LastName': 'Knobel', 'Affiliation': 'Ross University School of Veterinary Medicine, Basseterre, Saint Kitts and Nevis. dknobel@rossvet.edu.kn.'}, {'ForeName': 'Christianah Ibironke', 'Initials': 'CI', 'LastName': 'Odita', 'Affiliation': 'University of Pretoria, Pretoria, South Africa.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Conan', 'Affiliation': 'Ross University School of Veterinary Medicine, Basseterre, Saint Kitts and Nevis.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Barry', 'Affiliation': 'Ross University School of Veterinary Medicine, Basseterre, Saint Kitts and Nevis.'}, {'ForeName': 'Marshalette', 'Initials': 'M', 'LastName': 'Smith-Anthony', 'Affiliation': 'Ross University School of Veterinary Medicine, Basseterre, Saint Kitts and Nevis.'}, {'ForeName': 'Juliet', 'Initials': 'J', 'LastName': 'Battice', 'Affiliation': 'Ross University School of Veterinary Medicine, Basseterre, Saint Kitts and Nevis.'}, {'ForeName': 'Shianne', 'Initials': 'S', 'LastName': 'England', 'Affiliation': 'Ross University School of Veterinary Medicine, Basseterre, Saint Kitts and Nevis.'}, {'ForeName': 'Bradford D', 'Initials': 'BD', 'LastName': 'Gessner', 'Affiliation': 'EpiVac Consulting Services, Anchorage, AK, USA.'}]",Trials,['10.1186/s13063-020-04467-z']
2477,32546211,Effect of hypothermic perfusion on phacoemulsification in cataract patients complicated with uveitis: a randomised trial.,"BACKGROUND


To evaluate the effectiveness and safety of hypothermic perfusion in the phacoemulsification of cataract caused by uveitis.
METHODS


This was a prospective, single-masked, randomised, controlled clinical trial. One hundred and six patients with uveitis-associated cataract underwent phacoemulsification with perfusion fluid temperature at 4 °C (treatment group) or 24 °C (control group). Anterior chamber inflammation grade, corneal endothelial cell count, corneal thickness, macular fovea thickness, and intraocular pressure (IOP) were observed on the 1st day and 7th day after operation.
RESULTS


The aqueous flare score was 0.83 ± 0.76 in the 4 °C group, which was lower than that in the 24 °C group (1.51 ± 1.02, p = 0.006) on the first day after operation. The aqueous cells score was lower in the 4 °C group (0.17 ± 0.38) than that in the 24 °C group (0.62 ± 0.94, p = 0.025). The mean corneal thickness of incision in the 4 °C group (907.66 ± 85.37 μm) was thinner than that in the 24 °C group (963.75 ± 103.81 μm, p = 0.005). Corneal endothelial cells density, macular fovea thickness, or percentage of transiently increased IOP showed no difference between the two groups (p > 0.05). There was no significant difference in all the main outcome parameters between the two groups on the 7th day after operation (p > 0.05).
CONCLUSIONS


Hypothermic perfusion in the phacoemulsification of uveitis-associated cataract is safe, and it can effectively inhibit anterior chamber inflammation and reduce the incisional corneal edema in the early postoperative stage.
TRIAL REGISTRATION


The study was registered with the Chinese Clinical Trial Registry. (http://www.chictr.org.cn/, Registration Number: ChiCTR1800016145).",2020,"Corneal endothelial cells density, macular fovea thickness, or percentage of transiently increased IOP showed no difference between the two groups (p > 0.05).","['One hundred and six patients with uveitis-associated cataract underwent', 'cataract patients complicated with uveitis']","['phacoemulsification with perfusion fluid temperature', 'hypothermic perfusion']","['aqueous cells score', 'mean corneal thickness of incision', 'incisional corneal edema', 'Anterior chamber inflammation grade, corneal endothelial cell count, corneal thickness, macular fovea thickness, and intraocular pressure (IOP', 'aqueous flare score', 'Corneal endothelial cells density, macular fovea thickness, or percentage of transiently increased IOP']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}]","[{'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}]","[{'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0429493', 'cui_str': 'Corneal thickness'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0010037', 'cui_str': 'Corneal edema'}, {'cui': 'C1096278', 'cui_str': 'Anterior chamber inflammation'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0016622', 'cui_str': 'Structure of fovea centralis'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0423281', 'cui_str': 'Anterior chamber flare'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0234708', 'cui_str': 'Raised intraocular pressure'}]",106.0,0.0548939,"Corneal endothelial cells density, macular fovea thickness, or percentage of transiently increased IOP showed no difference between the two groups (p > 0.05).","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Wenjuan', 'Initials': 'W', 'LastName': 'Wan', 'Affiliation': 'The First Affiliated Hospital of Chongqing Medical University, Chongqing Key Laboratory of Ophthalmology and Chongqing Eye Institute, Chongqing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Xun', 'Affiliation': 'Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Xiong', 'Affiliation': 'Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Binge', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'The Second affiliated hospital of Baotou medical college, Baotou, Inner Mongolia Autonomous Region, China.'}, {'ForeName': 'Yongguo', 'Initials': 'Y', 'LastName': 'Xiang', 'Affiliation': 'Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Zhouyu', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ji', 'Affiliation': 'The First Affiliated Hospital of Chongqing Medical University, Chongqing Key Laboratory of Ophthalmology and Chongqing Eye Institute, Chongqing, China.'}, {'ForeName': 'Peizeng', 'Initials': 'P', 'LastName': 'Yang', 'Affiliation': 'The First Affiliated Hospital of Chongqing Medical University, Chongqing Key Laboratory of Ophthalmology and Chongqing Eye Institute, Chongqing, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Hu', 'Affiliation': 'Chongqing Medical University, Chongqing, China. 42222@qq.com.'}]",BMC ophthalmology,['10.1186/s12886-020-01507-9']
2478,32546217,"Fast-track- recovery surgery with a whey-protein-infused carbohydrate-loading drink pre-operatively and early oral feeding post-operatively among surgical gynaecological cancer patients: study protocol of an open-labelled, randomised controlled trial.","INTRODUCTION


There has been growing evidence on the favourable outcomes of fast-track-recovery (FTR) surgery; to expedite recovery, minimise complications, and reduce the length of hospital stay for surgical patients. However, there is lack of evidence on the effectiveness of FTR in surgical gynaecological cancer (GC) patients. Most of the previous studies did not focus on feeding composition in the FTR surgery protocol. This study aims to determine the effectiveness of FTR feeding with a whey-protein-infused carbohydrate-loading drink pre-operatively and early oral feeding post-operatively on post-operative outcomes among surgical GC patients.
METHODS/DESIGN


This open-labelled, randomised controlled trial (RCT) will randomly allocate patients into intervention and control groups. Ambulated Malaysian aged over 18 years and scheduled for elective surgery for (suspected) GC, will be included in this study. The intervention group will be given whey-protein-infused carbohydrate-loading drinks on the evening before their operation and 3 h before their operation as well as started on early oral feeding 4 h post-operatively. The control group will be fasted overnight pre-operation and only allowed plain water, and return to a normal diet is allowed when bowel sounds return post-operatively. The primary outcomes of study are length of post-operative hospital stay, length of clear-fluid tolerance, solid-food tolerance and bowel function. Additional outcome measures are changes in nutritional status, biochemical profile and functional status. Data will be analysed on an intention-to-treat basis.
TRIAL REGISTRATION


ClinicalTrials.gov, ID: NCT03667755. Retrospectively registered on 12 September 2018; Protocol version: version 3 dated 27 September 2017.",2020,"The primary outcomes of study are length of post-operative hospital stay, length of clear-fluid tolerance, solid-food tolerance and bowel function.","['surgical GC patients', 'Retrospectively registered on 12 September 2018; Protocol version: version 3 dated 27 September 2017', 'Ambulated Malaysian aged over 18\u2009years and scheduled for elective surgery for (suspected) GC', 'surgical gynaecological cancer (GC) patients', 'surgical gynaecological cancer patients']","['whey-protein-infused carbohydrate-loading drinks', 'Fast-track- recovery surgery with a whey-protein-infused carbohydrate-loading drink pre-operatively and early oral feeding post-operatively', 'FTR feeding with a whey-protein-infused carbohydrate-loading drink pre-operatively and early oral feeding post-operatively', 'FTR', 'fasted overnight pre-operation and only allowed plain water, and return to a normal diet']","['length of hospital stay', 'length of post-operative hospital stay, length of clear-fluid tolerance, solid-food tolerance and bowel function', 'changes in nutritional status, biochemical profile and functional status']","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C4707055', 'cui_str': 'Infuse'}, {'cui': 'C4277655', 'cui_str': 'Carbohydrate Loading Diet'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0184625', 'cui_str': 'Normal diet'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0453847', 'cui_str': 'Clear fluid'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0453855', 'cui_str': 'Solid food'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.0875391,"The primary outcomes of study are length of post-operative hospital stay, length of clear-fluid tolerance, solid-food tolerance and bowel function.","[{'ForeName': 'Chiou Yi', 'Initials': 'CY', 'LastName': 'Ho', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Science, Universiti Putra Malaysia, 43400, Serdang, Selangor, Malaysia.'}, {'ForeName': 'Zuriati', 'Initials': 'Z', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Science, Universiti Putra Malaysia, 43400, Serdang, Selangor, Malaysia. zuriatiib@upm.edu.my.'}, {'ForeName': 'Zalina', 'Initials': 'Z', 'LastName': 'Abu Zaid', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Science, Universiti Putra Malaysia, 43400, Serdang, Selangor, Malaysia.'}, {'ForeName': ""Zulfitri 'Azuan"", 'Initials': ""Z'"", 'LastName': 'Mat Daud', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Science, Universiti Putra Malaysia, 43400, Serdang, Selangor, Malaysia.'}, {'ForeName': 'Nor Baizura', 'Initials': 'NB', 'LastName': 'Md Yusop', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Science, Universiti Putra Malaysia, 43400, Serdang, Selangor, Malaysia.'}]",Trials,['10.1186/s13063-020-04462-4']
2479,32546251,A comparison of two personalization and adaptive cognitive rehabilitation approaches: a randomized controlled trial with chronic stroke patients.,"BACKGROUND


Paper-and-pencil tasks are still widely used for cognitive rehabilitation despite the proliferation of new computer-based methods, like VR-based simulations of ADL's. Studies have established construct validity of VR assessment tools with their paper-and-pencil version by demonstrating significant associations with their traditional construct-driven measures. However, VR rehabilitation intervention tools are mostly developed to include mechanisms such as personalization and adaptation, elements that are disregarded in their paper-and-pencil counterparts, which is a strong limitation of comparison studies. Here we compare the clinical impact of a personalized and adapted paper-and-pencil training and a content equivalent and more ecologically valid VR-based ADL's simulation.
METHODS


We have performed a trial with 36 stroke patients comparing Reh@City v2.0 (adaptive cognitive training through everyday tasks VR simulations) with Task Generator (TG: content equivalent and adaptive paper-and-pencil training). The intervention comprised 12 sessions, with a neuropsychological assessment pre, post-intervention and follow-up, having as primary outcomes: general cognitive functioning (assessed by the Montreal Cognitive Assessment - MoCA), attention, memory, executive functions and language specific domains.
RESULTS


A within-group analysis revealed that the Reh@City v2.0 improved general cognitive functioning, attention, visuospatial ability and executive functions. These improvements generalized to verbal memory, processing speed and self-perceived cognitive deficits specific assessments. TG only improved in orientation domain on the MoCA, and specific processing speed and verbal memory outcomes. However, at follow-up, processing speed and verbal memory improvements were maintained, and a new one was revealed in language. A between-groups analysis revealed Reh@City v2.0 superiority in general cognitive functioning, visuospatial ability, and executive functions on the MoCA.
CONCLUSIONS


The Reh@City v2.0 intervention with higher ecological validity revealed higher effectiveness with improvements in different cognitive domains and self-perceived cognitive deficits in everyday life, and the TG intervention retained fewer cognitive gains for longer.
TRIAL REGISTRATION


The trial is registered at ClinicalTrials.gov, number NCT02857803. Registered 5 August 2016, .",2020,"A between-groups analysis revealed Reh@City v2.0 superiority in general cognitive functioning, visuospatial ability, and executive functions on the MoCA.
CONCLUSIONS


The Reh@City v2.0 intervention with higher ecological validity revealed higher effectiveness with improvements in different cognitive domains and self-perceived cognitive deficits in everyday life, and the TG intervention retained fewer cognitive gains for longer.
","['36 stroke patients comparing', 'chronic stroke patients']","['two personalization and adaptive cognitive rehabilitation approaches', 'Reh@City v2.0 (adaptive cognitive training through everyday tasks VR simulations) with Task Generator (TG: content equivalent and adaptive paper-and-pencil training', 'neuropsychological assessment pre, post-intervention and follow-up, having as primary outcomes: general cognitive functioning (assessed by the Montreal Cognitive Assessment - MoCA), attention, memory, executive functions and language specific domains', ""personalized and adapted paper-and-pencil training and a content equivalent and more ecologically valid VR-based ADL's simulation""]","['MoCA, and specific processing speed and verbal memory outcomes', 'general cognitive functioning, attention, visuospatial ability and executive functions', 'processing speed and verbal memory improvements', 'verbal memory, processing speed and self-perceived cognitive deficits specific assessments', 'cognitive gains', 'general cognitive functioning, visuospatial ability, and executive functions']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]","[{'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0441661', 'cui_str': 'Everyday tasks'}, {'cui': 'C0237638', 'cui_str': 'Generator'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0441059', 'cui_str': 'Pencil'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]","[{'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",36.0,0.0444724,"A between-groups analysis revealed Reh@City v2.0 superiority in general cognitive functioning, visuospatial ability, and executive functions on the MoCA.
CONCLUSIONS


The Reh@City v2.0 intervention with higher ecological validity revealed higher effectiveness with improvements in different cognitive domains and self-perceived cognitive deficits in everyday life, and the TG intervention retained fewer cognitive gains for longer.
","[{'ForeName': 'Ana Lúcia', 'Initials': 'AL', 'LastName': 'Faria', 'Affiliation': 'Madeira Interactive Technologies Institute, Universidade da Madeira, Funchal, Portugal. ana.faria@m-iti.org.'}, {'ForeName': 'Maria Salomé', 'Initials': 'MS', 'LastName': 'Pinho', 'Affiliation': 'Faculdade de Psicologia e de Ciências da Educação, Universidade de Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Sergi', 'Initials': 'S', 'LastName': 'Bermúdez I Badia', 'Affiliation': 'Madeira Interactive Technologies Institute, Universidade da Madeira, Funchal, Portugal.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00691-5']
2480,32546256,IMPROVEjob - Participatory intervention to improve job satisfaction of general practice teams: a model for structural and behavioural prevention in small and medium-sized enterprises - a study protocol of a cluster-randomised controlled trial.,"BACKGROUND


Perceived high chronic stress is twice as prevalent among German general practitioners (GPs) and non-physician medical staff compared to the general population. The reasons are multi-factorial and include patient, practice, healthcare system and societal factors, such as multi-morbidity, the diversity of populations and innovations in medical care. Also, practice-related factors, like stressful patient-staff interactions, poor process management of waiting times and lack of leadership, play a role. This publicly funded study evaluates the effectiveness of the newly developed participatory, interdisciplinary, and multimodal IMPROVEjob intervention on improving job satisfaction among general practice personnel. The intervention aims at structural stress prevention with regard to working conditions and behavioural stress prevention for leaders and other practice personnel.
METHODS


In this cluster-randomised controlled trial, a total of 56 general practices will be assigned to either (1) participation in the IMPROVEjob intervention or (2) the waiting-list control group. The IMPROVEjob intervention consists of the following elements: three workshops, a toolbox with supplemental material and an implementation period with regular contact to so-called IMPROVEjob facilitators. The first workshop, addressing leadership issues, is designed for physicians with leadership responsibilities only. The two subsequent workshops target all GP and non-physician personnel; they address issues of communication (with patients and within the team), self-care and team-care and practice organisation. During the 9-month implementation period, practices will be contacted by IMPROVEjob facilitators to enhance motivation. Additionally, the practices will have access to the toolbox materials online. All participants will complete questionnaires at baseline and follow up. The primary outcome is the change in job satisfaction as measured by the respective scale of the validated German version of the Copenhagen Psychosocial Questionnaire (COPSOQ, version 2018). Secondary outcomes obtained by questionnaires and - qualitatively - by facilitators comprise psychosocial working conditions including leadership aspects, expectations and experiences of the workshops, team and individual efforts and organisational changes.
DISCUSSION


It is hypothesised that participation in the IMPROVEjob intervention will improve job satisfaction and thus constitute a structural and behavioural prevention strategy for the promotion of psychological wellbeing of personnel in general practices and prospectively in other small and medium sized enterprises.
TRIAL REGISTRATION


German Clinical Trials Register: DRKS00012677. Registered on 16 October 2019. Retrospectively, https://www.drks.de/drks_web/navigate.do?navigationId=trial. HTML&TRIAL_ID = DRKS00012677.",2020,"The primary outcome is the change in job satisfaction as measured by the respective scale of the validated German version of the Copenhagen Psychosocial Questionnaire (COPSOQ, version 2018).","['56 general practices', 'general practice personnel']","['IMPROVEjob intervention or (2) the waiting-list control group', 'IMPROVEjob - Participatory intervention', 'IMPROVEjob intervention', 'structural stress prevention with regard to working conditions and behavioural stress prevention for leaders and other practice personnel', 'toolbox with supplemental material and an implementation period with regular contact to so-called IMPROVEjob facilitators', 'multimodal IMPROVEjob intervention']","['job satisfaction', 'questionnaires and - qualitatively - by facilitators comprise psychosocial working conditions including leadership aspects, expectations and experiences of the workshops, team and individual efforts and organisational changes', 'change in job satisfaction as measured by the respective scale of the validated German version of the Copenhagen Psychosocial Questionnaire (COPSOQ, version 2018']","[{'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023181', 'cui_str': 'Leadership'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C2607870', 'cui_str': 'Version'}]",56.0,0.062167,"The primary outcome is the change in job satisfaction as measured by the respective scale of the validated German version of the Copenhagen Psychosocial Questionnaire (COPSOQ, version 2018).","[{'ForeName': 'Birgitta M', 'Initials': 'BM', 'LastName': 'Weltermann', 'Affiliation': 'Institute of General Practice and Family Medicine, University Hospital Bonn, University of Bonn, Venusberg-Campus 1, 53127, Bonn, Germany. birgitta.weltermann@ukbonn.de.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Kersting', 'Affiliation': 'Institute for General Medicine, University Hospital Essen, University of Duisburg-Essen, Hufelandstr 55, 45122, Essen, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Pieper', 'Affiliation': 'Institute for Medical Informatics, Biometry and Epidemiology, University Hospital Essen, University of Duisburg-Essen, Hufelandstr 55, 45147, Essen, Germany.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Seifried-Dübon', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Hospital Tuebingen, Osianderstraße 5, 72076, Tuebingen, Germany.'}, {'ForeName': 'Annegret', 'Initials': 'A', 'LastName': 'Dreher', 'Affiliation': 'Institute of General Practice and Family Medicine, University Hospital Bonn, University of Bonn, Venusberg-Campus 1, 53127, Bonn, Germany.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Linden', 'Affiliation': 'Institute of General Practice and Family Medicine, University Hospital Bonn, University of Bonn, Venusberg-Campus 1, 53127, Bonn, Germany.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Rind', 'Affiliation': 'Institute of Occupational and Social Medicine and Health Services Research, University Hospital Tuebingen, Wilhelmstr 27, 72074, Tuebingen, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Ose', 'Affiliation': 'Center for Clinical Trials, University Hospital Essen, University of Duisburg-Essen, Hufelandstr. 55, 45147, Essen, Germany.'}, {'ForeName': 'Karl-Heinz', 'Initials': 'KH', 'LastName': 'Jöckel', 'Affiliation': 'Institute for Medical Informatics, Biometry and Epidemiology, University Hospital Essen, University of Duisburg-Essen, Hufelandstr 55, 45147, Essen, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Junne', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Hospital Tuebingen, Osianderstraße 5, 72076, Tuebingen, Germany.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Werners', 'Affiliation': 'Institute for Operations Research, Ruhr University Bochum, Universitätsstr 150, 44801, Bochum, Germany.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Schroeder', 'Affiliation': 'Center for Clinical Trials, University Hospital Essen, University of Duisburg-Essen, Hufelandstr. 55, 45147, Essen, Germany.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Bois', 'Affiliation': 'Center for Clinical Trials, University Hospital Essen, University of Duisburg-Essen, Hufelandstr. 55, 45147, Essen, Germany.'}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Siegel', 'Affiliation': 'Institute of Occupational and Social Medicine and Health Services Research, University Hospital Tuebingen, Wilhelmstr 27, 72074, Tuebingen, Germany.'}, {'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Thielmann', 'Affiliation': 'Institute of General Practice and Family Medicine, University Hospital Bonn, University of Bonn, Venusberg-Campus 1, 53127, Bonn, Germany.'}, {'ForeName': 'Monika A', 'Initials': 'MA', 'LastName': 'Rieger', 'Affiliation': 'Institute of Occupational and Social Medicine and Health Services Research, University Hospital Tuebingen, Wilhelmstr 27, 72074, Tuebingen, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Kasten', 'Affiliation': 'Institute of General Practice and Family Medicine, University Hospital Bonn, University of Bonn, Venusberg-Campus 1, 53127, Bonn, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04427-7']
2481,32546262,Study protocol for daiobotanpito combined with antibiotic therapy for treatment of acute diverticulitis: a study protocol for a randomized controlled trial.,"BACKGROUND


Colonic diverticular disease has been increasing in prevalence due to the rapidly aging global population, but standard treatment has not changed dramatically in recent years. Daiobotanpito (DBT; Da Huang Mu Dan Tang in Chinese) has been used in medical treatment of acute abdominal abscesses, such as appendicitis or diverticulitis in traditional Japanese (Kampo) medicine for many years, based on more than 3000 years of experience. Prior to this study, a retrospective open-label trial was conducted to compare patients with acute diverticulitis who received oral DBT combined with intravenous antibiotics with those who received intravenous antibiotic alone; it showed a positive effect of DBT on acute diverticulitis. We aim to investigate whether moderate to severe acute diverticulitis shows greater improvement with intravenous antibiotics plus orally administered DBT compared with intravenous antibiotics plus placebo.
METHODS


This is a two-group, randomized, double-blind, placebo-controlled, multi-center trial, which is designed to evaluate the efficacy and safety of DBT in patients with moderate to severe diverticulitis treated with intravenous antibiotics. Eligible participants will be randomized to either a treatment group receiving a 10-day oral DBT regimen plus conventional therapy or a control group receiving a 10-day placebo regimen plus conventional therapy. The primary outcome will be success in treating diverticulitis: the success rate will be defined as elimination of abdominal pain within 4 days in all patients, and in patients with fever (body temperature ≧ 37.5 °C) on inclusion into this study, fever relief with reduction in body temperature to < 37.5 °C within 3 days. Secondary endpoints will include the number of hospitalization days, changes in inflammatory response (C-reactive protein (CRP), white blood cell (WBC) and neutrophil counts), fever type, number of days before beginning food intake, recurrence rate (observation for 1 year after registration), and adverse event expression rate. Assessments will be performed at baseline and on the day of discharge. The recurrence rate will be recorded at 1 year after registration.
DISCUSSION


This study is expected to provide evidence to support the clinical benefits of DBT in the treatment of acute diverticulitis. It may also provide evidence on the efficacy and safety of DBT in the recurrence of acute diverticulitis.
TRIAL REGISTRATION


UMIN-CTR: UMIN000027381. Registered on 27 April 2017. https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000031377, and changed to jRCTs041180063, registered on 30 July 2019; as a result of the revision of the domestic law in 2018 in Japan.",2020,"Secondary endpoints will include the number of hospitalization days, changes in inflammatory response (C-reactive protein (CRP), white blood cell (WBC) and neutrophil counts), fever type, number of days before beginning food intake, recurrence rate (observation for 1 year after registration), and adverse event expression rate.","['patients with acute diverticulitis who received oral DBT combined with intravenous antibiotics with those who received', 'Eligible participants', 'patients with moderate to severe diverticulitis treated with intravenous antibiotics', 'acute diverticulitis']","['Daiobotanpito (DBT; Da Huang Mu Dan Tang in Chinese', 'intravenous antibiotics plus placebo', 'daiobotanpito combined with antibiotic therapy', 'intravenous antibiotics plus orally administered DBT', 'intravenous antibiotic alone', '10-day oral DBT regimen plus conventional therapy or a control group receiving a 10-day placebo regimen plus conventional therapy', 'DBT', 'placebo']","['efficacy and safety', 'recurrence rate', 'success in treating diverticulitis: the success rate will be defined as elimination of abdominal pain', 'number of hospitalization days, changes in inflammatory response (C-reactive protein (CRP), white blood cell (WBC) and neutrophil counts), fever type, number of days before beginning food intake, recurrence rate (observation for 1\u2009year after registration), and adverse event expression rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518989', 'cui_str': 'Acute diverticulitis'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0012813', 'cui_str': 'Diverticulitis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0035509', 'cui_str': 'Rhubarb'}, {'cui': 'C0010961', 'cui_str': 'Danazol'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0012813', 'cui_str': 'Diverticulitis'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",,0.364188,"Secondary endpoints will include the number of hospitalization days, changes in inflammatory response (C-reactive protein (CRP), white blood cell (WBC) and neutrophil counts), fever type, number of days before beginning food intake, recurrence rate (observation for 1 year after registration), and adverse event expression rate.","[{'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Ogawa-Ochiai', 'Affiliation': 'Department of Japanese Traditional (Kampo) Medicine, Kanazawa University Hospital, 13-1 Takaramachi, Kanazawa City, Ishikawa, 920-8641, Japan. ikkandoo@gmail.com.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Yoshimura', 'Affiliation': 'Center for Integrated Medical Research, Hiroshima University Hospital, Hiroshima University, Kasumi 1-2-3, Minami-ku, Hiroshima, 734-8551, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Shirai', 'Affiliation': 'Department of Japanese Traditional (Kampo) Medicine, Kanazawa University Hospital, 13-1 Takaramachi, Kanazawa City, Ishikawa, 920-8641, Japan.'}, {'ForeName': 'Seisho', 'Initials': 'S', 'LastName': 'Sakai', 'Affiliation': 'Department of Pediatric Surgery, Kanazawa University Hospital, Takaramachi 13-1, Kanazawa, Ishikawa, 920-8641, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Moriyama', 'Affiliation': 'Department of Thoracic, Cardiovascular and General Surgery, Kanazawa University Hospital, Takaramachi 13-1, Kanazawa, Ishikawa, 920-8641, Japan.'}, {'ForeName': 'Keishi', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Department of Gastrointestinal Surgery, Kanazawa University Hospital, Takaramachi 13-1, Kanazawa, Ishikawa, 920-8641, Japan.'}, {'ForeName': 'Toshinori', 'Initials': 'T', 'LastName': 'Murayama', 'Affiliation': 'Innovative Clinical Research Center, Kanazawa University Hospital, Takaramachi 13-1, Kanazawa, Ishikawa, 920-8641, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Molecular-Targeting Cancer Prevention, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 3-2-17-2F Imabashi, Chuo-ku, Osaka, 541-0042, Japan.'}]",Trials,['10.1186/s13063-020-04370-7']
2482,32546269,Short-course antibiotic regimen compared to conventional antibiotic treatment for gram-positive cocci infective endocarditis: randomized clinical trial (SATIE).,"BACKGROUND


Most serious complications of infective endocarditis (IE) appear in the so-called ""critical phase"" of the disease, which represents the first days after diagnosis. The majority of patients overcoming the acute phase has a favorable outcome, yet they remain hospitalized for a long period of time mainly to complete antibiotic therapy. The major hypothesis of this trial is that in patients with clinically stable IE and adequate response to antibiotic treatment, without signs of persistent infection, periannular complications or metastatic foci, a shorter antibiotic time period would be as efficient and safe as the classic 4 to 6 weeks antibiotic regimen.
METHODS


Multicenter, prospective, randomized, controlled open-label, phase IV clinical trial with a non-inferiority design to evaluate the efficacy of a short course (2 weeks) of parenteral antibiotic therapy compared with conventional antibiotic therapy (4-6 weeks).
SAMPLE


patients with IE caused by gram-positive cocci, having received at least 10 days of conventional antibiotic treatment, and at least 7 days after surgery when indicated, without clinical, analytical, microbiological or echocardiographic signs of persistent infection. Estimated sample size: 298 patients.
INTERVENTION


Control group: standard duration antibiotic therapy, (4 to 6 weeks) according to ESC guidelines recommendations. Experimental group: short-course antibiotic therapy for 2 weeks. The incidence of the primary composite endpoint of all-cause mortality, unplanned cardiac surgery, symptomatic embolisms and relapses within 6 months after the inclusion in the study will be prospectively registered and compared.
CONCLUSIONS


SATIE will investigate whether a two weeks short-course of intravenous antibiotics in patients with IE caused by gram-positive cocci, without signs of persistent infection, is not inferior in safety and efficacy to conventional antibiotic treatment (4-6 weeks).
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT04222257 (January 7, 2020). EudraCT 2019-003358-10.",2020,"The incidence of the primary composite endpoint of all-cause mortality, unplanned cardiac surgery, symptomatic embolisms and relapses within 6 months after the inclusion in the study will be prospectively registered and compared.
","['Estimated sample size: 298 patients', 'gram-positive cocci infective endocarditis']","['conventional antibiotic treatment', 'conventional antibiotic therapy', 'Control group: standard duration antibiotic therapy', 'parenteral antibiotic therapy']","['cause mortality, unplanned cardiac surgery, symptomatic embolisms and relapses']","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018155', 'cui_str': 'Gram-positive coccus'}, {'cui': 'C0014121', 'cui_str': 'Bacterial endocarditis'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",,0.161137,"The incidence of the primary composite endpoint of all-cause mortality, unplanned cardiac surgery, symptomatic embolisms and relapses within 6 months after the inclusion in the study will be prospectively registered and compared.
","[{'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Olmos', 'Affiliation': 'Instituto Cardiovascular, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdSSC), Prof. Martín Lagos s/n, 28040, Madrid, Spain. carmen.olmosblanco@gmail.com.'}, {'ForeName': 'Isidre', 'Initials': 'I', 'LastName': 'Vilacosta', 'Affiliation': 'Instituto Cardiovascular, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdSSC), Prof. Martín Lagos s/n, 28040, Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'López', 'Affiliation': 'Servicio de Cardiología, Instituto de Ciencias del Corazón (ICICOR), CIBERCV, Valladolid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Sáez', 'Affiliation': 'Servicio de Medicina Interna-Infecciosas, Instituto de Investigación Sanitaria del Hospital Universitario de la Princesa, Madrid, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Anguita', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario Reina Sofía de Córdoba, Córdoba, Spain.'}, {'ForeName': 'Pablo Elpidio', 'Initials': 'PE', 'LastName': 'García-Granja', 'Affiliation': 'Servicio de Cardiología, Instituto de Ciencias del Corazón (ICICOR), CIBERCV, Valladolid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Sarriá', 'Affiliation': 'Servicio de Medicina Interna-Infecciosas, Instituto de Investigación Sanitaria del Hospital Universitario de la Princesa, Madrid, Spain.'}, {'ForeName': 'Jacobo', 'Initials': 'J', 'LastName': 'Silva', 'Affiliation': 'Servicio de Cirugía Cardiaca, Hospital Universitario Central de Oviedo, Oviedo, Spain.'}, {'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Álvarez-Álvarez', 'Affiliation': 'Servicio de Cardiología y Unidad Coronaria, Complejo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'María Amparo', 'Initials': 'MA', 'LastName': 'Martínez-Monzonis', 'Affiliation': 'Servicio de Cardiología y Unidad Coronaria, Complejo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Castillo', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario Reina Sofía de Córdoba, Córdoba, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Seijas', 'Affiliation': 'Servicio de Cardiología y Unidad Coronaria, Complejo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'López-Picado', 'Affiliation': 'Unidad de Investigación y Ensayos Clinicos. Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdSSC), Madrid, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Peral', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario de Son Espases, Palma de Mallorca, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Maroto', 'Affiliation': 'Instituto Cardiovascular, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdSSC), Prof. Martín Lagos s/n, 28040, Madrid, Spain.'}, {'ForeName': 'J Alberto', 'Initials': 'JA', 'LastName': 'San Román', 'Affiliation': 'Servicio de Cardiología, Instituto de Ciencias del Corazón (ICICOR), CIBERCV, Valladolid, Spain.'}]",BMC infectious diseases,['10.1186/s12879-020-05132-1']
2483,32546347,"Re: Timothy J. Wilt, Tien N. Vo, Lisa Langsetmo, et al. Radical Prostatectomy or Observation for Clinically Localized Prostate Cancer: Extended Follow-up of the Prostate Cancer Intervention Versus Observation Trial (PIVOT). Eur Urol. In press. https://doi.org/10.1016/j.eururo.2020.02.009: External Validity of the Updated Prostate Cancer Intervention Versus Observation Trial (PIVOT).",,2020,,['Clinically Localized Prostate Cancer'],"['Radical Prostatectomy or Observation', 'Updated Prostate Cancer Intervention', 'https://doi.org/10.1016/j.eururo.2020.02.009']",[],"[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0236809,,"[{'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Rakic', 'Affiliation': 'Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Keeley', 'Affiliation': 'Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Firas', 'Initials': 'F', 'LastName': 'Abdollah', 'Affiliation': 'Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI, USA. Electronic address: firas.abdollah@gmail.com.'}]",European urology oncology,['10.1016/j.euo.2020.05.002']
2484,32546384,Spontaneous vaginal birth following induction with intravenous oxytocin: Three oxytocic regimes to minimise blood loss post birth.,"BACKGROUND


No evidence was identified in relation to the downward titration/cessation of intravenous oxytocin post spontaneous vaginal birth, in the absence of postpartum haemorrhage (PPH); suggesting clinicians' management is based on personal preference in the absence of evidence.
AIM


To determine the proportion of induced women with a spontaneous vaginal birth and PPH, when intravenous oxytocin was utilised intrapartum and ceased 15, 30 or 60minutes post birth.
METHODS


This three armed pilot randomised controlled trial, was undertaken on the Birth Suite of an Australian tertiary obstetric hospital. Incidence of PPH was assessed using univariable and adjusted logistic regression, which compared the effect of titrating intravenous oxytocin post birth on the likelihood of PPH, relative to the 15minute titration group.
FINDINGS


Postpartum haemorrhage occurred in 26% (30 of 115), 20% (23 of 116), and 22% (30 of 134) of women randomised to a 15, 30 and 60minute titration time post birth, with no statistically significant differences between groups.
CONCLUSION


There was no difference in the incidence of PPH between the three groups. Therefore, we question the benefit of delaying cessation of intravenous oxytocin for 60minutes post birth. Further investigation in this cohort is recommended, to compare the incidence of PPH when intravenous oxytocin is ceased either immediately, or 30minutes post birth. This research is warranted, as an evidence-based framework is lacking, to guide midwives globally in relation to their management of intravenous oxytocin post an induced spontaneous vaginal birth, in the absence of PPH.",2020,There was no difference in the incidence of PPH between the three groups.,['Birth Suite of an Australian tertiary obstetric hospital'],['oxytocin'],"['Incidence of PPH', 'Postpartum haemorrhage', 'incidence of PPH', 'Spontaneous vaginal birth']","[{'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C1384485', 'cui_str': 'Delivery normal'}]",,0.333482,There was no difference in the incidence of PPH between the three groups.,"[{'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Lewis', 'Affiliation': 'School of Nursing, Midwifery and Paramedicine, Curtin University, Bentley, Perth, Western Australia 6102, Australia; Department of Nursing and Midwifery Education and Research, King Edward Memorial Hospital, Subiaco, Perth, Western Australia, 6008, Australia. Electronic address: Lucy.Lewis@curtin.edu.au.'}, {'ForeName': 'Dorota A', 'Initials': 'DA', 'LastName': 'Doherty', 'Affiliation': 'Division of Obstetrics and Gynaecology, The University of Western Australia, Nedlands, Perth, Western Australia 6009, Australia. Electronic address: dorota.doherty@uwa.edu.au.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Conwell', 'Affiliation': 'Labour and Birth Suite, King Edward Memorial Hospital, Subiaco, Perth, Western Australia, 6008, Australia. Electronic address: Marian.Conwell@health.wa.gov.au.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Bradfield', 'Affiliation': 'School of Nursing, Midwifery and Paramedicine, Curtin University, Bentley, Perth, Western Australia 6102, Australia; Department of Nursing and Midwifery Education and Research, King Edward Memorial Hospital, Subiaco, Perth, Western Australia, 6008, Australia. Electronic address: zoe.bradfield@curtin.edu.au.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Sajogo', 'Affiliation': 'Pharmacy Department, King Edward Memorial Hospital, Subiaco, Perth, Western Australia, 6008, Australia. Electronic address: Monica.Sajogo@health.wa.gov.au.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Epee-Bekima', 'Affiliation': 'Division of Obstetrics and Gynaecology, The University of Western Australia, Nedlands, Perth, Western Australia 6009, Australia; Department of Obstetrics and Gynaecology, King Edward Memorial Hospital, Subiaco, Perth, Western Australia 6008, Australia. Electronic address: Mathias.epee-bekima@health.wa.gov.au.'}, {'ForeName': 'Yvonne L', 'Initials': 'YL', 'LastName': 'Hauck', 'Affiliation': 'School of Nursing, Midwifery and Paramedicine, Curtin University, Bentley, Perth, Western Australia 6102, Australia; Department of Nursing and Midwifery Education and Research, King Edward Memorial Hospital, Subiaco, Perth, Western Australia, 6008, Australia. Electronic address: y.hauck@curtin.edu.au.'}]",Women and birth : journal of the Australian College of Midwives,['10.1016/j.wombi.2020.05.006']
2485,32546421,Small changes in glucose variability induced by low and high glycemic index diets are not associated with changes in β-cell function in adults with pre-diabetes.,"Oscillating glucose levels can increase oxidative stress and may contribute to β-cell dysfunction. We tested the hypothesis that increased glycemic variability contributes to β-cell dysfunction by experimentally altering glucose variability with controlled diets varying in glycemic index (GI). Fifty-two adults with prediabetes received a 2-week moderate GI (GI = 55-58) control diet followed by randomization to a four-week low GI (LGI: GI < 35) or high GI (HGI HI > 70) diet. Those on the HGI diet were randomized to placebo or the antioxidant N-acetylcysteine (NAC). Participants underwent blinded CGMS, fasting oxidative stress markers and an intravenous glucose tolerance test to estimate β-cell function (disposition index: DI). On the control diet, DI was inversely correlated with SD glucose (r = -0.314, p = 0.03), but neither DI nor glucose variability were associated with oxidative stress markers. The LGI diet decreased SD glucose (Control 0.96 ± 0.08 vs. LGI 0.79 ± 0.06, p = 0.02) while the HGI diet increased it (Control 0.88 ± 0.06 vs. HGI 1.06 ± 0.07, p = 0.03). Neither DI nor oxidative stress markers changed after the LGI or HGI diets. NAC had no effect on DI, glucose variability or oxidative stress markers. We conclude small changes in glucose variability induced by dietary GI in adults with pre-diabetes are unlikely to contribute to β-cell dysfunction.",2020,"The LGI diet decreased SD glucose (Control 0.96 ± 0.08 vs. LGI 0.79 ± 0.06, p = 0.02) while the HGI diet increased it (Control 0.88 ± 0.06 vs. HGI 1.06 ± 0.07, p = 0.03).","['Fifty-two adults with prediabetes received a', 'adults with pre-diabetes']","['2-week moderate GI (GI\u202f=\u202f55-58) control diet followed by randomization to a four-week low GI (LGI: GI\u202f<\u202f35) or high GI (HGI HI', 'antioxidant N-acetylcysteine (NAC', 'NAC', 'placebo']","['oxidative stress markers', 'oxidative stress', 'SD glucose', 'glucose variability', 'β-cell function', 'DI, glucose variability or oxidative stress markers']","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}]",52.0,0.0150612,"The LGI diet decreased SD glucose (Control 0.96 ± 0.08 vs. LGI 0.79 ± 0.06, p = 0.02) while the HGI diet increased it (Control 0.88 ± 0.06 vs. HGI 1.06 ± 0.07, p = 0.03).","[{'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Utzschneider', 'Affiliation': 'Research and Development, Department of Medicine, 1660 S Columbian Way (151), VA Puget Sound Health Care System, Seattle, WA 98108, USA; Division of Metabolism, Endocrinology and Nutrition, University of Washington, 1959 NE Pacific Street, Seattle, WA 98195-6426, USA. Electronic address: kutzschn@uw.edu.'}, {'ForeName': 'Tonya N', 'Initials': 'TN', 'LastName': 'Johnson', 'Affiliation': 'Research and Development, Department of Medicine, 1660 S Columbian Way (151), VA Puget Sound Health Care System, Seattle, WA 98108, USA; Seattle Institute for BIomedical and Clinical Research, Seattle, WA, USA.'}, {'ForeName': 'Kara L', 'Initials': 'KL', 'LastName': 'Breymeyer', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, Seattle, WA 98109, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Bettcher', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Washington, 1959 NE Pacific Street, Seattle, WA 98195-6426, USA. Electronic address: bettcher@uw.edu.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Raftery', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Washington, 1959 NE Pacific Street, Seattle, WA 98195-6426, USA. Electronic address: draftery@uw.edu.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Newton', 'Affiliation': 'Kaiser Permanente Health Research Institute, 1730 Minor Ave, Seattle, WA 98101, USA. Electronic address: Katherine.M.Newton@kp.org.'}, {'ForeName': 'Marian L', 'Initials': 'ML', 'LastName': 'Neuhouser', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, Seattle, WA 98109, USA. Electronic address: mneuhous@fredhutch.org.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2020.107586']
2486,31635497,Oral plasma kallikrein inhibitor BCX7353 for treatment of hereditary angioedema.,"Hereditary angioedema (HAE) is rare disorder caused by a  SERPING1  gene mutation that triggers severe swelling of the skin and upper airway. Treatment options for HAE with deficient and dysfunctional C1-inhibitor are expanding to include small-molecule drugs that inhibit protein interactions in the kallikrein-kinin system. Discovered by BioCryst Pharmaceuticals, BCX7353 is a synthetic, once-daily, small molecule drug that can be taken as an oral capsule to treat HAE attacks and for prophylaxis. This article will summarize recent and current BCX7353 clinical trials. Overall, results indicate BCX7353 is a promising form of therapy with a rapid 1 h onset of action, long duration of action, and acceptable tolerance.",2019,Hereditary angioedema (HAE) is rare disorder caused by a  SERPING1  gene mutation that triggers severe swelling of the skin and upper airway.,['hereditary angioedema'],"['Oral plasma kallikrein inhibitor BCX7353', 'BCX7353']",[],"[{'cui': 'C0019243', 'cui_str': 'Hereditary angioedema'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C2919497', 'cui_str': 'Kallikrein inhibitor'}]",[],,0.036697,Hereditary angioedema (HAE) is rare disorder caused by a  SERPING1  gene mutation that triggers severe swelling of the skin and upper airway.,"[{'ForeName': 'Jacqueline R', 'Initials': 'JR', 'LastName': 'Hwang', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, MD\xa021201, USA.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Hwang', 'Affiliation': 'Pennsylvania State University College of Medicine, Hershey, PA\xa017033, USA.'}, {'ForeName': 'Ansh', 'Initials': 'A', 'LastName': 'Johri', 'Affiliation': 'Pennsylvania State University College of Medicine, Hershey, PA\xa017033, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Craig', 'Affiliation': 'Department of Medicine & Pediatrics, College of Medicine, Allergy, Asthma & Immunology, Pennsylvania State University, Hershey, PA 17033, USA.'}]",Immunotherapy,['10.2217/imt-2019-0128']
2487,31683159,A randomised observational study of individualised variations in the start position of the closed-kinetic chain upper extremity stability test.,"OBJECTIVES


To assess the reliability, precision and differences between scores produced using the standard 36″ start position and 3 modified start positions of the Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST), towards normalisation to the individual.
DESIGN


RCT of 4 conditions.
SETTING


Clinical.
PARTICIPANTS


Thirty-four asymptomatic individuals.
MAIN OUTCOME MEASURES


Using an RCT method, variations in CKCUEST starting hand position were tested using hand spacing at standard 36″, 50% height, bi-acromial distance, and bi-acromial distance with reach to 36″. The average number of touches over 3 × 15 s maximal efforts were used to assess the intra-variation reliability, minimum detectable change (MDC) and differences to the standard 36″ start position.
RESULTS


The most reliable variation was the 50% height (ICC: 0.93) and with the smallest MDC (14%). 36″ results were second-most reliable (ICC: 0.90), with a low MDC (19%). Significant differences were found between bi-acromial and 50% height to the 36″ standard setup.
CONCLUSIONS


A setup position where the hand separation is 50% of the individual's height offers excellent repeated measures reliability and the smallest MDC, suggesting it is the most sensitive to change and is a recommendation to clinicians. Conversion calculations between start variations are presented.",2020,"36″ results were second-most reliable (ICC: 0.90), with a low MDC (19%).",['Thirty-four asymptomatic individuals'],[],[],"[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],[],34.0,0.0325666,"36″ results were second-most reliable (ICC: 0.90), with a low MDC (19%).","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Callaway', 'Affiliation': 'Department of Rehabilitation and Sport Science, Bournemouth University, United Kingdom. Electronic address: acallaway@bournemouth.ac.uk.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Peck', 'Affiliation': 'Department of Rehabilitation and Sport Science, Bournemouth University, United Kingdom.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Ellis', 'Affiliation': 'Department of Rehabilitation and Sport Science, Bournemouth University, United Kingdom.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Williams', 'Affiliation': 'Department of Rehabilitation and Sport Science, Bournemouth University, United Kingdom.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2019.10.007']
2488,31738117,Cost-effectiveness of pembrolizumab versus chemotherapy as first-line treatment in PD-L1-positive advanced non-small-cell lung cancer in the USA.,"Aim:  This analysis aimed to evaluate the cost-effectiveness of pembrolizumab monotherapy as first-line treatment in advanced non-small-cell lung cancer patients with a programmed death ligand 1 (PD-L1) tumor proportion score ≥1% from a US payer perspective.  Materials & methods:  A partitioned survival model was developed using efficacy and safety data from the KEYNOTE-042 trial and projected over 20 years. Costs accounted for treatment, toxicity and disease management. Quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios were reported.  Results:  Pembrolizumab resulted in an expected gain of 0.60 life years and 0.49 QALYs compared with platinum-based chemotherapy. The incremental cost-effectiveness ratio was US$130,155/QALY.  Conclusion:  Pembrolizumab is projected to be cost-effective compared with platinum-based chemotherapy as first-line treatment for advanced non-small-cell lung cancer with PD-L1 tumor proportion score ≥1%.",2019,Pembrolizumab resulted in an expected gain of 0.60 life years and 0.49 QALYs compared with platinum-based chemotherapy.,"['PD-L1-positive advanced non-small-cell lung cancer in the\xa0USA', 'advanced non-small-cell lung cancer patients with a programmed death ligand 1 (PD-L1) tumor proportion score ≥1% from a US payer perspective']","['Pembrolizumab', 'pembrolizumab versus chemotherapy', 'pembrolizumab monotherapy', 'platinum-based chemotherapy']","['Cost-effectiveness', 'incremental cost-effectiveness ratio', 'Quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios', 'cost-effectiveness', 'toxicity and disease management']","[{'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.0726087,Pembrolizumab resulted in an expected gain of 0.60 life years and 0.49 QALYs compared with platinum-based chemotherapy.,"[{'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Center for Observational & Real World Evidence (CORE), Merck & Co., Inc., Kenilworth, NJ\xa007033, USA.'}, {'ForeName': 'Gilberto de Lima', 'Initials': 'GL', 'LastName': 'Lopes', 'Affiliation': 'Sylvester Comprehensive Cancer Center, University of Miami & the Miller School of Medicine, Miami, FL\xa033136, USA.'}, {'ForeName': 'Ralph P', 'Initials': 'RP', 'LastName': 'Insinga', 'Affiliation': 'Center for Observational & Real World Evidence (CORE), Merck & Co., Inc., Kenilworth, NJ\xa007033, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Burke', 'Affiliation': 'Center for Observational & Real World Evidence (CORE), Merck & Co., Inc., Kenilworth, NJ\xa007033, USA.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Ejzykowicz', 'Affiliation': 'Center for Observational & Real World Evidence (CORE), Merck & Co., Inc., Kenilworth, NJ\xa007033, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'HTA Statistics Europe, Merck Sharp & Dohme, 1200 Brussels, Belgium.'}, {'ForeName': 'Josephine L', 'Initials': 'JL', 'LastName': 'Feliciano', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD\xa021287, USA.'}]",Immunotherapy,['10.2217/imt-2019-0178']
2489,32543876,Manual Physical Therapy in the Treatment of Functional Constipation in Children: A Pilot Randomized Controlled Trial.,"Objectives:  Make a preliminary assessment of the efficacy of manual physical therapy (MPT) compared to conventional pharmacologic treatment (CPT) in chronic pediatric functional constipation (CPC).  Design:  A pilot randomized and controlled trial was conducted.  Settings/Location:  Subjects were recruited in a tertiary university hospital in the north of Spain.  Subjects:  Forty-seven children (2-14 years) were included. Participants were assessed by Pediatric Gastroenterologist. They were recruited in a tertiary university hospital. Subjects were randomly allocated. MPT was performed in a private clinic.  Interventions:  Control group (CG) received CPT and intervention group (IG) received MPT, consisting in nine sessions of MPT with a 45-min initial session and 30 min for the rest of sessions distributed weekly during the first and second months and biweekly in the third month.  Outcome Measures:  At times 0-1-3 months and 5 years, results obtained were checked and compared, according to the defecatory pattern (""Symptom Severity Score"" SSS), quality of life (Pediatric Quality of Life Inventory Scale), Bristol Stool Form Scale (BSFS), and the defecation frequency (DF).  Results:  Results from SSS, BSFS, and DF revealed no statistically significant differences between groups in median values at any follow-up. However, there were significant changes over time. The full sample median for SSS was reduced from baseline 24 (interquartile range 20-27) to 11 (6-13) at month 1, 7 (3-13) at month 3, (8 CG; 5 IG), and 5 (1-12) at year 5. The BSFS scale increased from 2 (1-3) at baseline to 4 (3-4) at month 1 and year 5. DF increases progressively from 1 per week to 5 in the fifth year. Higher rates of quality of life were observed at month 3 in IG for the total, physical, and emotional functioning scores and at fifth year for total, emotional, social, and school functioning scores.  Conclusions:  This study gives preliminary evidence of no difference between MPT and CPT for improvement in measures of CPC, although there was some advantage for MPT in quality of life. Study results justify the conduct of a full-scale efficacy trial of MPT, as well as a noninferiority trial comparing MPT and CPT.",2020,"Higher rates of quality of life were observed at month 3 in IG for the total, physical, and emotional functioning scores and at fifth year for total, emotional, social, and school functioning scores.  ","['Subjects were recruited in a tertiary university hospital in the north of Spain', 'Functional Constipation in Children', 'chronic pediatric functional constipation (CPC', 'Subjects:  Forty-seven children (2-14 years) were included']","['Manual Physical Therapy', 'conventional pharmacologic treatment (CPT', 'CPT', 'MPT', 'manual physical therapy (MPT', 'Control group (CG', 'MPT and CPT']","['quality of life', 'total, emotional, social, and school functioning scores', 'defecatory pattern (""Symptom Severity Score"" SSS), quality of life (Pediatric Quality of Life Inventory Scale), Bristol Stool Form Scale (BSFS), and the defecation frequency (DF', 'full sample median for SSS', 'SSS, BSFS, and DF', 'BSFS scale']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0401146', 'cui_str': 'Constipation - functional'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0056911', 'cui_str': ""cytidylyl-(3'-5')-cytidine""}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0037052', 'cui_str': 'Sick sinus syndrome'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1997606', 'cui_str': 'Bristol stool form scale'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",47.0,0.0551073,"Higher rates of quality of life were observed at month 3 in IG for the total, physical, and emotional functioning scores and at fifth year for total, emotional, social, and school functioning scores.  ","[{'ForeName': 'María', 'Initials': 'M', 'LastName': 'Blanco Díaz', 'Affiliation': 'Surgery and Medical Surgical Specialities Department, Faculty of Medicine and Health Sciences, University of Oviedo, Oviedo, Asturias, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Bousoño García', 'Affiliation': 'Paediatric Gastroenterology and Nutrition Unit, Hospital Universitario Central de Asturias (HUCA), Oviedo, Asturias, Spain.'}, {'ForeName': 'Diana Katherine', 'Initials': 'DK', 'LastName': 'Segura Ramírez', 'Affiliation': 'Paediatric Gastroenterology and Nutrition Unit, Hospital Universitario Central de Asturias (HUCA), Oviedo, Asturias, Spain.'}, {'ForeName': 'Álvaro Manuel', 'Initials': 'ÁM', 'LastName': 'Rodríguez Rodriguez', 'Affiliation': 'Independent Anthropologist, Oviedo, Asturias, Spain.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2020.0047']
2490,32544011,The effect of coenzyme Q10 supplementation on inflammatory and endothelial dysfunction markers in overweight/obese polycystic ovary syndrome patients.,"Background:  This study aimed at determining the effects of coenzyme Q10 (CoQ10) supplementation on the inflammatory and endothelial dysfunction indices among overweight and obese women with polycystic ovary syndrome (PCOS). Methods:  This randomized double-blind, placebo-controlled clinical trial was performed among overweight and obese women diagnosed with PCOS. Forty three PCOS women were randomly assigned to two groups: one group received 200 mg CoQ10 capsules per day ( n  = 22) and the other received placebo ( n  = 21) for 8 weeks. Biomarkers of inflammation and endothelial dysfunction including high sensitivity C-reactive protein (hs-CRP), tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), vascular cell adhesion molecule-1 (VCAM-1), intercellular adhesion molecule-1 (ICAM-1) and E-selectin were measured and compared before and after the intervention. Results:  At the end of study, compared with pldacebo, CoQ10 supplementation resulted in significant decreases in serum levels of TNF-α ( p  = 0.009), hs-CRP and IL-6 ( p  = 0.001,  p  = 0.007, respectively). In addition, supplementation with CoQ10 resulted in a significant reduction in serum VCAM-1 ( p  = .002) and E-selectin ( p  = .006) compared with the control group. There were no significant differences for serum ICAM-1. Conclusions:  The present study showed that CoQ10 supplementation for 8 weeks had a beneficial effect on inflammatory and endothelial dysfunction markers in overweight and obese patients with PCOS.",2020,"In addition, supplementation with CoQ10 resulted in a significant reduction in serum VCAM-1 ( p  = .002) and E-selectin ( p  = .006) compared with the control group.","['overweight and obese women diagnosed with PCOS', 'overweight and obese women with polycystic ovary syndrome (PCOS', 'overweight and obese patients with PCOS', 'overweight/obese polycystic ovary syndrome patients', 'Forty three PCOS women']","['pldacebo, CoQ10 supplementation', 'CoQ10 supplementation', '200\u2009mg CoQ10 capsules', 'coenzyme Q10 (CoQ10) supplementation', 'coenzyme Q10 supplementation', 'placebo']","['hs-CRP and IL-6', 'serum ICAM-1', 'serum VCAM-1', 'Biomarkers of inflammation and endothelial dysfunction including high sensitivity C-reactive protein (hs-CRP), tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), vascular cell adhesion molecule-1 (VCAM-1), intercellular adhesion molecule-1 (ICAM-1) and E-selectin', 'serum levels of TNF-α', 'inflammatory and endothelial dysfunction markers']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450368', 'cui_str': '43'}]","[{'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0063695', 'cui_str': 'Lymphocyte antigen CD54'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0115305', 'cui_str': 'Lymphocyte antigen CD62E'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",43.0,0.543846,"In addition, supplementation with CoQ10 resulted in a significant reduction in serum VCAM-1 ( p  = .002) and E-selectin ( p  = .006) compared with the control group.","[{'ForeName': 'Shiva', 'Initials': 'S', 'LastName': 'Taghizadeh', 'Affiliation': 'Department of Biochemistry and Diet Therapy, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Azimeh', 'Initials': 'A', 'LastName': 'Izadi', 'Affiliation': 'Department of Biochemistry and Diet Therapy, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Shabnam', 'Initials': 'S', 'LastName': 'Shirazi', 'Affiliation': 'Department of Biochemistry and Diet Therapy, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Marziyeh', 'Initials': 'M', 'LastName': 'Parizad', 'Affiliation': ""Women's Reproductive Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.""}, {'ForeName': 'Bahram', 'Initials': 'B', 'LastName': 'Pourghassem Gargari', 'Affiliation': 'Nutrition Research Center, Department of Biochemistry and Diet Therapy, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology,['10.1080/09513590.2020.1779689']
2491,32544067,The effect of hole size on failure loads of the distal humerus fenestration in Outerbridge-Kashiwagi arthroplasty: A biomechanical study.,"OBJECTIVE


The aim of this study was to biomechanically assess the effect of humeral-fenestration size in the Outerbridge-Kashiwagi arthroplasty on the ultimate failure load of the distal humerus in a synthetic bone model.
METHODS


We biomechanically tested the influence of different humeral-fenestration sizes on the failure load of the distal humerus in Outerbridge-Kashiwagi arthroplasty. A total of 50 synthetic humerus models were divided into 5 groups based on the fenestration size: 10 mm, 12 mm, 15 mm, 18 mm, and 20 mm. All the samples were randomly assigned to receive either axial or anteroposterior (AP) loading and then loaded to failure at a rate of 2 mm/min on a material testing machine. The data regarding ultimate failure loads under the axial and AP loading were analyzed.
RESULTS


Under the AP loading, the mean ultimate failure loads of the 18 mm and 20 mm groups were lower than those of the other groups. Under the axial loading, the mean ultimate failure load of the 10 mm group was significantly greater than that of the 15 mm, 18 mm, and 20 mm groups. Additionally, the ultimate failure load of the 20 mm group was significantly lower than that of the 12 mm, 15 mm, and 18 mm groups.
CONCLUSION


The distal humeral fenestrations with a size greater than 18 mm may offer poor biomechanical properties in the Outerbridge-Kashiwagi ulnohumeral arthroplasty.",2020,"Under the AP loading, the mean ultimate failure loads of the 18 mm and 20 mm groups were lower than those of the other groups.","['50 synthetic humerus models', 'Outerbridge-Kashiwagi arthroplasty']","['hole size', 'axial or anteroposterior (AP) loading']","['mean ultimate failure loads', 'ultimate failure load']","[{'cui': 'C0020164', 'cui_str': 'Bone structure of humerus'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}]","[{'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205131', 'cui_str': 'Axial'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",50.0,0.0468683,"Under the AP loading, the mean ultimate failure loads of the 18 mm and 20 mm groups were lower than those of the other groups.","[{'ForeName': 'Chih-Kai', 'Initials': 'CK', 'LastName': 'Hong', 'Affiliation': 'Department of Orthopaedic Surgery, National Cheng Kung University Hospital, School of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Kai-Lan', 'Initials': 'KL', 'LastName': 'Hsu', 'Affiliation': 'Department of Orthopaedic Surgery, National Cheng Kung University Hospital, School of Medicine, National Cheng Kung University, Tainan, Taiwan;Department of Biomedical Engineering, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Fa-Chuan', 'Initials': 'FC', 'LastName': 'Kuan', 'Affiliation': 'Department of Orthopaedic Surgery, National Cheng Kung University Hospital, School of Medicine, National Cheng Kung University, Tainan, Taiwan;Department of Biomedical Engineering, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Chi-Hsiu', 'Initials': 'CH', 'LastName': 'Wang', 'Affiliation': 'Department of Nursing, National Cheng Kung University Hospital, School of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Ping-Hui', 'Initials': 'PH', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics, Chi-Mei Medical Center, Tainan, Taiwan.'}, {'ForeName': 'Wei-Ren', 'Initials': 'WR', 'LastName': 'Su', 'Affiliation': 'Department of Orthopaedic Surgery, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan;Skeleton Materials and Bio-compatibility Core Lab, Research Center of Clinical Medicine, National Cheng Kung University Hospital, College of Medicine,National Cheng Kung University, Tainan, Taiwan.'}]",Acta orthopaedica et traumatologica turcica,['10.5152/j.aott.2020.03.59']
2492,32544109,Effects of dry needling technique into trigger points of the sternocleidomastoid muscle in migraine headache: A randomized controlled trial.,"OBJECTIVE


The study aimed to investigate the effect of dry needling (DN) into trigger points of the sternocleidomastoid muscle in migraine headache patients.
DESIGN


Forty subjects with a migraine headache, originating from myofacial trigger points into the sternocleidomastoid (SCM) muscle (20 subjects in DN group and 20 subjects in control group) volunteered to participate in this study. The subjects in the treatment group received three sessions of dry needling in the myofascial trigger point region. Headache frequency, headache intensity, headache duration, drug consumption, muscle thickness, pressure pain threshold (PPT), and cervical range of motion were assessed before, immediately after intervention, and at one-month follow-up period. Also, this article was extracted from Iranian Register of Clinical Trials number IRCT20171219037956N1.
RESULTS


The experimental group showed significant reduction in the headache parameters immediately after the intervention and at one month's follow-up, as compared to the control group. The PPT of SCM muscle, cervical range of motion, and muscle thickness significantly increased in the DN group in comparison to the control group (p < 0.001).
CONCLUSION


The application of dry needling technique caused an improvement in symptoms of migraine patients. Therefore, this technique may be prescribed for treating migraine patients with myofacial trigger points in the sternocleidomastoid muscle.",2020,"The PPT of SCM muscle, cervical range of motion, and muscle thickness significantly increased in the DN group in comparison to the control group (p < 0.001).
","['migraine headache patients', 'Forty subjects with a migraine headache, originating from myofacial trigger points into the sternocleidomastoid (SCM) muscle (20 subjects in DN group and 20 subjects in control group) volunteered to participate in this study', 'migraine headache', 'migraine patients']","['dry needling (DN', 'dry needling technique', 'dry needling']","['headache parameters', 'Headache frequency, headache intensity, headache duration, drug consumption, muscle thickness, pressure pain threshold (PPT), and cervical range of motion', 'PPT of SCM muscle, cervical range of motion, and muscle thickness']","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0224153', 'cui_str': 'Structure of sternocleidomastoid muscle'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0224153', 'cui_str': 'Structure of sternocleidomastoid muscle'}]",40.0,0.0137744,"The PPT of SCM muscle, cervical range of motion, and muscle thickness significantly increased in the DN group in comparison to the control group (p < 0.001).
","[{'ForeName': 'Tahere', 'Initials': 'T', 'LastName': 'Rezaeian', 'Affiliation': 'Physiotherapy Department, Social Welfare and Rehabilitation Sciences University, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mosallanezhad', 'Affiliation': 'Assistant Professor, Physiotherapy Department and research center on aging, Social Welfare and Rehabilitation Sciences University, Tehran, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Nourbakhsh', 'Affiliation': 'Professor, Physiotherapy Department, North Georgia University, The USA.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Norouzi', 'Affiliation': 'Epidemiologist, Assistant Professor, Social Determinants of Health Research Center, Social Welfare and Rehabilitation Sciences University, Tehran, Iran.'}, {'ForeName': 'Firoozeh', 'Initials': 'F', 'LastName': 'Sajedi', 'Affiliation': 'Professor, Clinical Sciences Department & Pediatric Neuro-Rehabilitation Research Center, University of Welfare & Rehabilitation, Tehran, Iran.'}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001504']
2493,32544117,Efficacy of Incontinence-Associated Dermatitis Intervention for Patients in Intensive Care: An Open-Label Pilot Randomized Controlled Trial.,"OBJECTIVE


To determine the feasibility of an adequately powered trial testing a long-acting cyanoacrylate skin protectant to prevent incontinence-associated dermatitis in critically ill patients.
METHODS


This open-label pilot randomized controlled feasibility study was conducted in the adult ICU of an Australian quaternary referral hospital. Patients were allocated to either an intervention group or a control group (usual care). The intervention was the application of a skin protectant (a durable, ultra-thin, transparent, waterproof, no-removal barrier film). Data collected by trained research nurses included demographic and clinical variables, skin assessment, and incontinence-associated dermatitis presence and severity. Data were analyzed using descriptive and inferential statistics.
RESULTS


Of the 799 patients screened, 85% were eliminated because of a short ICU stay or other exclusion criteria. The mean proportion of patients not meeting any of the exclusion criteria was 22% on each screening day. Protocol fidelity was followed for 90% of intervention participant study days. Retention of participants was 86% (31 participants out of 36), 15 in the intervention group and 16 in the control group. Enrolled patients had a mean age of 59 years, 50% were obese, 67% were male, and 36% were smokers. Two patients (11%) in the intervention group developed incontinence-associated dermatitis, compared with three (17%) in the control group.
CONCLUSIONS


This study reports no significant findings between the two groups. Difficulty in recruitment and feasibility issues might be overcome with changes to inclusion criteria and study design.",2020,"Two patients (11%) in the intervention group developed incontinence-associated dermatitis, compared with three (17%) in the control group.
","['Patients in Intensive Care', 'Enrolled patients had a mean age of 59 years, 50% were obese, 67% were male, and 36% were smokers', 'critically ill patients', '799 patients screened', 'adult ICU of an Australian quaternary referral hospital']","['control group (usual care', 'cyanoacrylate skin protectant', 'skin protectant (a durable, ultra-thin, transparent, waterproof, no-removal barrier film', 'Incontinence-Associated Dermatitis Intervention']","['demographic and clinical variables, skin assessment, and incontinence-associated dermatitis presence and severity', 'incontinence-associated dermatitis', 'Protocol fidelity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010507', 'cui_str': 'Cyanoacrylate'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0033613', 'cui_str': 'Protective agent'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0522503', 'cui_str': 'Translucent'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0558035', 'cui_str': 'Skin assessment'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]",85.0,0.0846662,"Two patients (11%) in the intervention group developed incontinence-associated dermatitis, compared with three (17%) in the control group.
","[{'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Coyer', 'Affiliation': ""At the Queensland University of Technology in Brisbane, Queensland, Australia, Fiona Coyer, PhD, MSc, RN, is Professor of Nursing, Joint Appointment Intensive Care Services, Royal Brisbane and Women's Hospital and School of Nursing; Jill Campbell, PhD, RN, Grad Dip (Wound Care), is Visiting Fellow, School of Nursing; and Anna Doubrovsky, MPH, BSc (Hons), is Data Analyst and Research Assistant, School of Nursing. Acknowledgments: The authors thank the research nurses (Fiona Boch and Stacey Watts) and all patients who participated. The study was sponsored by 3M, which provided funding for research assistants, the investigational product, and training to two authors on the product application. The authors have disclosed no other financial relationships related to this article. Submitted May 20, 2019; accepted in revised form August 29, 2019.""}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Campbell', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Doubrovsky', 'Affiliation': ''}]",Advances in skin & wound care,['10.1097/01.ASW.0000666904.35944.a3']
2494,32544119,Efficacy of a Natural Topical Skin Ointment for Managing Split-Thickness Skin Graft Donor Sites: A Pilot Double-blind Randomized Controlled Trial.,"OBJECTIVE


To evaluate the safety and efficacy of a new topical skin ointment with natural ingredients (aloe vera, honey, and peppermint) for dressing skin graft donor sites.
DESIGN


A double-blind, placebo-controlled, randomized clinical trial.
PATIENTS AND INTERVENTION


Researchers enrolled patients who were referred for split-thickness skin graft after burns or surgical wounds on the scalp or face area. For each patient, a thin layer of skin (depth, 0.04 mm; approximate size, less than 15 × 7 cm) was harvested from the thigh by a plastic surgeon with an electric or manual dermatome. The donor sites were divided and randomized to receive either natural ointment or petroleum jelly as a topical agent to dressing. Topical agents were applied on donor site wounds on days 0, 4, 7, and 14.
MAIN OUTCOME MEASURES


Wound size, pain, erythema, pruritus, patient discomfort, complications, and physician satisfaction were evaluated at each visit.
MAIN RESULTS


Among 28 patients, there was no significant difference between the two treatment agents regarding the rate of wound healing (P = .415), pain (P = .081), pruritus (P = .527), and patient discomfort (P = .616). The ointment was superior to petroleum jelly in reducing wound erythema (P = .001) and was associated with significantly better treatment satisfaction (P < .001).
CONCLUSIONS


The natural topical ointment investigated in this study may be an acceptable alternative to petroleum jelly in caring for split-thickness donor skin graft donor site wounds to effectively promote wound healing, prevent infection and scarring, reduce pain, and comfort the patient.",2020,"The ointment was superior to petroleum jelly in reducing wound erythema (P = .001) and was associated with significantly better treatment satisfaction (P < .001).
","['28 patients', 'after burns or surgical wounds on the scalp or face area']","['new topical skin ointment with natural ingredients (aloe vera, honey, and peppermint', 'natural ointment or petroleum jelly as a topical agent to dressing', 'Natural Topical Skin Ointment', 'split-thickness skin graft', 'placebo']","['patient discomfort', 'Wound size, pain, erythema, pruritus, patient discomfort, complications, and physician satisfaction', 'Managing Split-Thickness Skin', 'safety and efficacy', 'pruritus', 'treatment satisfaction', 'wound erythema', 'pain', 'rate of wound healing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0332803', 'cui_str': 'Surgical wound'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C1875575', 'cui_str': 'Skin Ointment'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0718405', 'cui_str': 'Aloe vera'}, {'cui': 'C0019906', 'cui_str': 'Honey'}, {'cui': 'C0070324', 'cui_str': 'Peppermint preparation'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0031262', 'cui_str': 'Petrolatum'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0439061', 'cui_str': 'Split thickness skin graft (procedure)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0423756', 'cui_str': 'Thickness of skin'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0406833', 'cui_str': 'Wound erythema'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",28.0,0.193495,"The ointment was superior to petroleum jelly in reducing wound erythema (P = .001) and was associated with significantly better treatment satisfaction (P < .001).
","[{'ForeName': 'Mohammad Saeed', 'Initials': 'MS', 'LastName': 'Abbasi', 'Affiliation': ""At the Tehran University of Medical Sciences, Tehran, Iran, Mohammad Saeed Abbasi, MD, is General Practitioner, Students' Scientific Research Center; Javad Rahmati, MD, is Professor of Plastic Surgery, Department of Plastic Surgery, Razi Hospital; Amir Houshang Ehsani, MD, is Professor of Dermatology, Department of Dermatology, Razi Hospital; Alireza Takzare, MD, is Assistant Professor of Anesthesiology, Children's Medical Center, School of Medicine; Alireza Partoazar, PhD, is Assistant Professor of Pharmacology, Experimental Medicine Research Center; and Nasrin Takzaree, PhD, is Assistant Professor of Histology, Anatomy Department, School of Medicine. The authors have disclosed no financial relationships related to this article. Submitted August 4, 2019; accepted in revised form October 1, 2019.""}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Rahmati', 'Affiliation': ''}, {'ForeName': 'Amir Houshang', 'Initials': 'AH', 'LastName': 'Ehsani', 'Affiliation': ''}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Takzare', 'Affiliation': ''}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Partoazar', 'Affiliation': ''}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Takzaree', 'Affiliation': ''}]",Advances in skin & wound care,['10.1097/01.ASW.0000666916.00983.64']
2495,32544125,Avoidance Moderates Cognitive Behavioral Therapy for Panic Disorder and Agoraphobia.,"Cognitive behavioral therapy (CBT), a well-validated treatment for panic disorder, includes interoceptive exposures and possibly in vivo exposures to agoraphobic situations. Testing predictors and moderators of CBT outcomes can improve treatment efficacy. Sixty-six individuals with panic disorder with or without agoraphobia were randomized to panic control therapy (PCT) (n = 32) or PCT and in vivo exposures to agoraphobic situations (PCT + IV) (n = 34). Secondary analyses using multilevel models with repeated measures design revealed that individuals who displayed more interoceptive avoidance and agoraphobic avoidance fared better after PCT than PCT + IV compared with individuals who displayed less avoidance. Results suggest that these individuals benefit from concentrated doses of exposures to their primary interoceptive concerns instead of additional exposures to agoraphobic situations. Exploratory analyses were also conducted on fear, demographic factors, and clinical characteristics. Findings inform clinical decision-making and personalized medicine. Limitations include low power for detecting small effect sizes.",2020,Secondary analyses using multilevel models with repeated measures design revealed that individuals who displayed more interoceptive avoidance and agoraphobic avoidance fared better after PCT than PCT + IV compared with individuals who displayed less avoidance.,"['Panic Disorder and Agoraphobia', 'Sixty-six individuals with panic disorder with or without agoraphobia']","['Cognitive behavioral therapy (CBT', 'Avoidance Moderates Cognitive Behavioral Therapy', 'panic control therapy (PCT', 'PCT and in vivo exposures to agoraphobic situations (PCT + IV']",['interoceptive avoidance and agoraphobic avoidance'],"[{'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]",[],66.0,0.0197249,Secondary analyses using multilevel models with repeated measures design revealed that individuals who displayed more interoceptive avoidance and agoraphobic avoidance fared better after PCT than PCT + IV compared with individuals who displayed less avoidance.,"[{'ForeName': 'Bita', 'Initials': 'B', 'LastName': 'Mesri', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Yihan', 'Initials': 'Y', 'LastName': 'Xiong', 'Affiliation': ''}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Marjorie Barnes-Horowitz', 'Affiliation': ''}, {'ForeName': 'Michelle Genevieve', 'Initials': 'MG', 'LastName': 'Craske', 'Affiliation': ''}]",The Journal of nervous and mental disease,['10.1097/NMD.0000000000001195']
2496,32544142,Comparison Between a Color-only Method and a Food and Drug Administration-approved Validation Method for a Pediatric Color-coded Syringe Using Midazolam: A Randomized Crossover Trial.,"OBJECTIVE


The objective of this study was to assess the use of a color-only method syringe for accuracy and timeliness when administrating midazolam. This method was compared with a U.S. Food and Drug Administration (FDA)-approved validation method.
METHODS


A prospective, randomized, crossover trial was conducted to compare the dosing accuracy and timeliness of the color-only syringe method versus the validation method. Twenty-five participants prepared pediatric midazolam doses according to their preferred method, a FDA-approved validation method, and a color-only method. Primary endpoints included dosing accuracy and time to medication administration.
RESULTS


The preferred 3-kg calculations had a median margin of error of 5.6% and a median time to completion of 55.6 seconds. The color-only method took less time to complete than the validation method (median time: 29.5 seconds vs 58.2 seconds). There was no statistically significant difference in errors between the color-only method and the validation method. None of the participants reported a mistake using the color-only method, whereas 25% (5/20) reported a mistake using the validation method. Only 20% (4/20) of participants believed that the validation method found or eliminated any mistakes. There were 8 medication errors identified when participants used the method of choice, 4 with the validation method, and 1 with the color-only method.
CONCLUSIONS


There was no significant difference in dosing errors between the FDA-approved validation method and the color-only method. Use of a color-only method did reduced time to medication administration when compared with a preferred method and an FDA-approved validation method.",2020,The color-only method took less time to complete than the validation method (median time: 29.5 seconds vs 58.2 seconds).,[],"['pediatric midazolam', 'Midazolam', 'color-only method syringe', 'midazolam']",['dosing accuracy and time to medication administration'],[],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}]","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3469597', 'cui_str': 'Administration of medication'}]",25.0,0.031766,The color-only method took less time to complete than the validation method (median time: 29.5 seconds vs 58.2 seconds).,"[{'ForeName': 'Caitlin M', 'Initials': 'CM', 'LastName': 'Howard', 'Affiliation': 'From the San Antonio Uniformed Services Health Education Consortium Military EMS and Disaster Medicine.'}, {'ForeName': 'Kristine L', 'Initials': 'KL', 'LastName': 'Jeffers', 'Affiliation': 'San Antonio Uniformed Services Health Education Consortium Emergency Medicine.'}, {'ForeName': 'Allyson A', 'Initials': 'AA', 'LastName': 'Arana', 'Affiliation': 'United States Air Force En Route Care Research Center, Fort Sam Houston.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Montez', 'Affiliation': 'Centre for Emergency Health Sciences, Spring Branch, TX.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Rahm', 'Affiliation': 'Centre for Emergency Health Sciences, Spring Branch, TX.'}]",Pediatric emergency care,['10.1097/PEC.0000000000002156']
2497,32544161,Usability and acceptability of a two-way texting intervention for post-operative follow-up for voluntary medical male circumcision in Zimbabwe.,"BACKGROUND


Voluntary medical male circumcision (MC) is safe and effective. Nevertheless, MC programs require multiple post-operative visits. In Zimbabwe, a randomized control trial (RCT) found that post-operative two-way texting (2wT) between clients and MC providers instead of in-person reviews reduced provider workload and safeguarded patient safety. A critical component of the RCT assessed usability and acceptability of 2wT among providers and clients. These findings inform scale-up of the 2wT approach to post-operative follow-up.
METHODS


The RCT assigned 362 adult MC clients with cell phones into 2wT; these men responded to 13 automated daily texts supported by interactive texting or in-person follow-up, when needed. A subset of 100 texting clients filled a self-administered usability survey on day 14. 2wT acceptability was ascertained via 2wT response rates. Among 2wT providers, eight key informant interviews focused on 2wT acceptability and usability. Influences of wage and age on response rates and client-reported potential AEs were explored using linear and logistic regression models, respectively.
RESULTS


Clients felt confident, comfortable, satisfied, and well-supported with 2wT-based follow-up; few noted texting challenges or concerns about healing. Clients felt 2wT saved them time and money. Response rates (92%) suggested 2wT acceptability. Both clients and providers felt 2wT was highly usable. Providers noted 2wT saved them time, empowered clients to engage in their healing, and closed gaps in MC service quality. For scale, providers reinforced good post-operative counseling on AEs and texting instructions. Wage and age did not influence text response rates or potential AE texts.
CONCLUSION


Results strongly suggest that 2wT is highly usable and acceptable for providers and patients. Men with concerns solicited provider guidance and reassurance offered via text. Providers noted that men engaged proactively in their healing. 2wT between providers and patients should be expanded for MC and considered for other short-term care contexts. The trial is registered on ClinicalTrials.gov, trial NCT03119337, and was activated on April 18, 2017. https://clinicaltrials.gov/ct2/show/NCT03119337.",2020,"Wage and age did not influence text response rates or potential AE texts.
","['100 texting clients filled a self-administered usability survey on day 14', 'post-operative follow-up for voluntary medical male circumcision in Zimbabwe', '362 adult MC clients with cell phones into 2wT; these men', 'Men with concerns solicited provider guidance and reassurance offered via text']",[],"['Providers noted 2wT saved them time, empowered clients to engage in their healing, and closed gaps in MC service quality', '2wT acceptability and usability', 'Response rates', 'Usability and acceptability', 'Clients felt 2wT saved them time and money']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0043476', 'cui_str': 'Zimbabwe'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1136359', 'cui_str': 'Cellular Phone'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0204558', 'cui_str': 'Group reassurance'}, {'cui': 'C1444648', 'cui_str': 'Offered'}]",[],"[{'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}]",362.0,0.0385762,"Wage and age did not influence text response rates or potential AE texts.
","[{'ForeName': 'Caryl', 'Initials': 'C', 'LastName': 'Feldacker', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Holeman', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Vernon', 'Initials': 'V', 'LastName': 'Murenje', 'Affiliation': 'International Training and Education Center for Health (I-TECH), Harare, Zimbabwe.'}, {'ForeName': 'Sinokuthemba', 'Initials': 'S', 'LastName': 'Xaba', 'Affiliation': 'Ministry of Health and Child Care, Harare, Zimbabwe.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Korir', 'Affiliation': 'Medic Mobile, Nairobi, Kenya.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Wambua', 'Affiliation': 'Medic Mobile, Nairobi, Kenya.'}, {'ForeName': 'Batsirai', 'Initials': 'B', 'LastName': 'Makunike-Chikwinya', 'Affiliation': 'International Training and Education Center for Health (I-TECH), Harare, Zimbabwe.'}, {'ForeName': 'Marrianne', 'Initials': 'M', 'LastName': 'Holec', 'Affiliation': 'International Training and Education Center for Health (I-TECH), Seattle, WA, United States of America.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Barnhart', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Mufuta', 'Initials': 'M', 'LastName': 'Tshimanga', 'Affiliation': 'Zimbabwe Community Health Intervention Project (ZiCHIRE), Harare, Zimbabwe.'}]",PloS one,['10.1371/journal.pone.0233234']
2498,32544221,Pharmacokinetic similarity demonstrated after crushing of the elbasvir/grazoprevir fixed-dose combination tablet for HCV infection.,"BACKGROUND


Finding a suitable treatment for HCV patients with swallowing disorders is still a major challenge. In practice, direct-acting antivirals are crushed without knowledge of adequate absorption. Crushing can alter drug exposure, possibly leading to treatment failure, development of resistance or toxicity. Currently, there is no information about crushing of the fixed-dose combination tablet of elbasvir/grazoprevir; therefore, crushing of this tablet is not recommended.
OBJECTIVES


To investigate the influence of crushing on the pharmacokinetics of the elbasvir/grazoprevir fixed-dose combination tablet.
METHODS


We conducted an open-label, two-period, randomized, cross-over, Phase I, single-dose trial in 11 healthy adult volunteers. Subjects randomly received whole-tablet elbasvir/grazoprevir or crushed and suspended elbasvir/grazoprevir in a fasted state. Pharmacokinetic similarity criteria (90% CIs lie within 70%-143% acceptance range) were used for AUC0-∞ and AUC0-72.
RESULTS


Mean plasma concentration-time curves of elbasvir and grazoprevir showed similar pharmacokinetic profiles. The primary pharmacokinetic parameters AUC0-∞ and AUC0-72 of elbasvir and grazoprevir after intake of a crushed tablet were on average 12%-16% higher compared with the whole tablet, but 90% CIs were all within the predefined boundaries of pharmacokinetic similarity. Crushing leads to a higher Cmax of grazoprevir (42%); no significant difference was found between treatments with regard to the Cmax of elbasvir. No serious adverse events were reported during the trial.
CONCLUSIONS


Pharmacokinetic similarity could be demonstrated for a crushed and suspended tablet compared with a whole tablet, without impacting drug safety or efficacy. Crushed and suspended administration of elbasvir/grazoprevir can be used in patients with swallowing disorders.",2020,Crushing leads to a higher Cmax of grazoprevir (42%); no significant difference was found between treatments with regard to the Cmax of elbasvir.,"['11 healthy adult volunteers', 'HCV patients with swallowing disorders', 'patients with swallowing disorders']","['whole-tablet elbasvir/grazoprevir or crushed and suspended elbasvir/grazoprevir', 'elbasvir/grazoprevir', 'elbasvir/grazoprevir fixed-dose combination tablet']","['serious adverse events', 'primary pharmacokinetic parameters AUC0-∞ and AUC0-72 of elbasvir and grazoprevir after intake of a crushed tablet', 'Cmax of elbasvir']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C4080453', 'cui_str': 'elbasvir and grazoprevir'}, {'cui': 'C0185060', 'cui_str': 'Crushing'}, {'cui': 'C0038959', 'cui_str': 'Suspending Agents'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4080453', 'cui_str': 'elbasvir and grazoprevir'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C4080052', 'cui_str': 'elbasvir'}]",11.0,0.0342333,Crushing leads to a higher Cmax of grazoprevir (42%); no significant difference was found between treatments with regard to the Cmax of elbasvir.,"[{'ForeName': 'Daniëlle W M', 'Initials': 'DWM', 'LastName': 'Pijnenburg', 'Affiliation': 'Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Minou', 'Initials': 'M', 'LastName': 'van Seyen', 'Affiliation': 'Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Evertine J', 'Initials': 'EJ', 'LastName': 'Abbink', 'Affiliation': 'Radboudumc Technology Center Clinical Studies, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Colbers', 'Affiliation': 'Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Joost P H', 'Initials': 'JPH', 'LastName': 'Drenth', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Burger', 'Affiliation': 'Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkaa230']
2499,32543682,Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes: A Randomized Clinical Trial.,"Importance


Continuous glucose monitoring (CGM) provides real-time assessment of glucose levels and may be beneficial in reducing hypoglycemia in older adults with type 1 diabetes.
Objective


To determine whether CGM is effective in reducing hypoglycemia compared with standard blood glucose monitoring (BGM) in older adults with type 1 diabetes.
Design, Setting, and Participants


Randomized clinical trial conducted at 22 endocrinology practices in the United States among 203 adults at least 60 years of age with type 1 diabetes.
Interventions


Participants were randomly assigned in a 1:1 ratio to use CGM (n = 103) or standard BGM (n = 100).
Main Outcomes and Measures


The primary outcome was CGM-measured percentage of time that sensor glucose values were less than 70 mg/dL during 6 months of follow-up. There were 31 prespecified secondary outcomes, including additional CGM metrics for hypoglycemia, hyperglycemia, and glucose control; hemoglobin A1c (HbA1c); and cognition and patient-reported outcomes, with adjustment for multiple comparisons to control for false-discovery rate.
Results


Of the 203 participants (median age, 68 [interquartile range {IQR}, 65-71] years; median type 1 diabetes duration, 36 [IQR, 25-48] years; 52% female; 53% insulin pump use; mean HbA1c, 7.5% [SD, 0.9%]), 83% used CGM at least 6 days per week during month 6. Median time with glucose levels less than 70 mg/dL was 5.1% (73 minutes per day) at baseline and 2.7% (39 minutes per day) during follow-up in the CGM group vs 4.7% (68 minutes per day) and 4.9% (70 minutes per day), respectively, in the standard BGM group (adjusted treatment difference, -1.9% (-27 minutes per day); 95% CI, -2.8% to -1.1% [-40 to -16 minutes per day]; P <.001). Of the 31 prespecified secondary end points, there were statistically significant differences for all 9 CGM metrics, 6 of 7 HbA1c outcomes, and none of the 15 cognitive and patient-reported outcomes. Mean HbA1c decreased in the CGM group compared with the standard BGM group (adjusted group difference, -0.3%; 95% CI, -0.4% to -0.1%; P <.001). The most commonly reported adverse events using CGM and standard BGM, respectively, were severe hypoglycemia (1 and 10), fractures (5 and 1), falls (4 and 3), and emergency department visits (6 and 8).
Conclusions and Relevance


Among adults aged 60 years or older with type 1 diabetes, continuous glucose monitoring compared with standard blood glucose monitoring resulted in a small but statistically significant improvement in hypoglycemia over 6 months. Further research is needed to understand the long-term clinical benefit.
Trial Registration


ClinicalTrials.gov Identifier: NCT03240432.",2020,"Mean HbA1c decreased in the CGM group compared with the standard BGM group (adjusted group difference, -0.3%; 95% CI, -0.4% to -0.1%; P <.001).","['older adults with type 1 diabetes', '22 endocrinology practices in the United States among 203 adults at least 60 years of age with type 1 diabetes', 'Older Adults With Type 1 Diabetes', 'adults aged 60 years or older with type 1 diabetes', '203 participants (median age, 68 [interquartile range {IQR}, 65-71] years; median type 1 diabetes duration, 36 [IQR, 25-48] years; 52% female; 53% insulin pump use; mean HbA1c, 7.5% [SD, 0.9%]), 83% used']","['CGM', 'standard blood glucose monitoring (BGM', 'CGM (n\u2009=\u2009103) or standard BGM', 'standard BGM', 'Importance\n\n\nContinuous glucose monitoring (CGM', 'standard blood glucose monitoring', 'Continuous Glucose Monitoring']","['severe hypoglycemia (1 and 10), fractures (5 and 1), falls (4 and 3), and emergency department visits', 'Hypoglycemia', 'Mean HbA1c', 'hypoglycemia', 'additional CGM metrics for hypoglycemia, hyperglycemia, and glucose control; hemoglobin A1c (HbA1c); and cognition and patient-reported outcomes, with adjustment for multiple comparisons to control for false-discovery rate', 'CGM-measured percentage of time that sensor glucose values', 'Median time with glucose levels']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0014137', 'cui_str': 'Endocrinology'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C4068881', 'cui_str': '0.9'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C4517526', 'cui_str': '103'}]","[{'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}]",203.0,0.1795,"Mean HbA1c decreased in the CGM group compared with the standard BGM group (adjusted group difference, -0.3%; 95% CI, -0.4% to -0.1%; P <.001).","[{'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Pratley', 'Affiliation': 'AdventHealth Translational Research Institute, Orlando, Florida.'}, {'ForeName': 'Lauren G', 'Initials': 'LG', 'LastName': 'Kanapka', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Rickels', 'Affiliation': 'Rodebaugh Diabetes Center, University of Pennsylvania Perelman School of Medicine, Philadelphia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ahmann', 'Affiliation': 'Oregon Health and Science University, Portland.'}, {'ForeName': 'Grazia', 'Initials': 'G', 'LastName': 'Aleppo', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Beck', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Bhargava', 'Affiliation': 'Iowa Diabetes and Endocrinology Research Center, Des Moines.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Bode', 'Affiliation': 'Atlanta Diabetes Associates, Atlanta, Georgia.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Carlson', 'Affiliation': 'Park Nicollet International Diabetes Center, Minneapolis, Minnesota.'}, {'ForeName': 'Naomi S', 'Initials': 'NS', 'LastName': 'Chaytor', 'Affiliation': 'Elson S. Floyd College of Medicine, Washington State University, Spokane.'}, {'ForeName': 'D Steven', 'Initials': 'DS', 'LastName': 'Fox', 'Affiliation': 'University of South California, School of Pharmacy, Los Angeles.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Goland', 'Affiliation': 'Naomi Berri Diabetes Center, Columbia University, New York, New York.'}, {'ForeName': 'Irl B', 'Initials': 'IB', 'LastName': 'Hirsch', 'Affiliation': 'University of Washington, Seattle.'}, {'ForeName': 'Davida', 'Initials': 'D', 'LastName': 'Kruger', 'Affiliation': 'Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Yogish C', 'Initials': 'YC', 'LastName': 'Kudva', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Levy', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Janet B', 'Initials': 'JB', 'LastName': 'McGill', 'Affiliation': 'Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Peters', 'Affiliation': 'Keck School of Medicine, University of Southern California, Los Angeles.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Philipson', 'Affiliation': 'University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Athena', 'Initials': 'A', 'LastName': 'Philis-Tsimikas', 'Affiliation': 'Scripps Whittier Diabetes Institute, La Jolla, California.'}, {'ForeName': 'Rodica', 'Initials': 'R', 'LastName': 'Pop-Busui', 'Affiliation': 'University of Michigan, Ann Arbor.'}, {'ForeName': 'Viral N', 'Initials': 'VN', 'LastName': 'Shah', 'Affiliation': 'Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Thompson', 'Affiliation': 'University of Massachusetts Medical School, Worcester.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Vendrame', 'Affiliation': 'University of Miami, Miami, Florida.'}, {'ForeName': 'Alandra', 'Initials': 'A', 'LastName': 'Verdejo', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Ruth S', 'Initials': 'RS', 'LastName': 'Weinstock', 'Affiliation': 'SUNY Upstate Medical University, Syracuse, New York.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Young', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill.'}, {'ForeName': 'Kellee M', 'Initials': 'KM', 'LastName': 'Miller', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.6928']
2500,32543683,Effect of Continuous Glucose Monitoring on Glycemic Control in Adolescents and Young Adults With Type 1 Diabetes: A Randomized Clinical Trial.,"Importance


Adolescents and young adults with type 1 diabetes exhibit the worst glycemic control among individuals with type 1 diabetes across the lifespan. Although continuous glucose monitoring (CGM) has been shown to improve glycemic control in adults, its benefit in adolescents and young adults has not been demonstrated.
Objective


To determine the effect of CGM on glycemic control in adolescents and young adults with type 1 diabetes.
Design, Setting, and Participants


Randomized clinical trial conducted between January 2018 and May 2019 at 14 endocrinology practices in the US including 153 individuals aged 14 to 24 years with type 1 diabetes and screening hemoglobin A1c (HbA1c) of 7.5% to 10.9%.
Interventions


Participants were randomized 1:1 to undergo CGM (CGM group; n = 74) or usual care using a blood glucose meter for glucose monitoring (blood glucose monitoring [BGM] group; n = 79).
Main Outcomes and Measures


The primary outcome was change in HbA1c from baseline to 26 weeks. There were 20 secondary outcomes, including additional HbA1c outcomes, CGM glucose metrics, and patient-reported outcomes with adjustment for multiple comparisons to control for the false discovery rate.
Results


Among the 153 participants (mean [SD] age, 17 [3] years; 76 [50%] were female; mean [SD] diabetes duration, 9 [5] years), 142 (93%) completed the study. In the CGM group, 68% of participants used CGM at least 5 days per week in month 6. Mean HbA1c was 8.9% at baseline and 8.5% at 26 weeks in the CGM group and 8.9% at both baseline and 26 weeks in the BGM group (adjusted between-group difference, -0.37% [95% CI, -0.66% to -0.08%]; P = .01). Of 20 prespecified secondary outcomes, there were statistically significant differences in 3 of 7 binary HbA1c outcomes, 8 of 9 CGM metrics, and 1 of 4 patient-reported outcomes. The most commonly reported adverse events in the CGM and BGM groups were severe hypoglycemia (3 participants with an event in the CGM group and 2 in the BGM group), hyperglycemia/ketosis (1 participant with an event in CGM group and 4 in the BGM group), and diabetic ketoacidosis (3 participants with an event in the CGM group and 1 in the BGM group).
Conclusions and Relevance


Among adolescents and young adults with type 1 diabetes, continuous glucose monitoring compared with standard blood glucose monitoring resulted in a small but statistically significant improvement in glycemic control over 26 weeks. Further research is needed to understand the clinical importance of the findings.
Trial Registration


ClinicalTrials.gov Identifier: NCT03263494.",2020,"Mean HbA1c was 8.9% at baseline and 8.5% at 26 weeks in the CGM group and 8.9% at both baseline and 26 weeks in the BGM group (adjusted between-group difference, -0.37% [95% CI, -0.66% to -0.08%]; P = .01).","['Importance\n\n\nAdolescents and young adults with type 1 diabetes', 'Adolescents and Young Adults With Type 1 Diabetes', '153 participants (mean [SD] age, 17 [3] years; 76 [50%] were female; mean [SD] diabetes duration, 9 [5] years), 142 (93%) completed the study', 'adolescents and young adults with type 1 diabetes', 'January 2018 and May 2019 at 14 endocrinology practices in the US including 153 individuals aged 14 to 24 years with type 1 diabetes and screening hemoglobin A1c (HbA1c) of 7.5% to 10.9']","['CGM (CGM group; n\u2009=\u200974) or usual care using a blood glucose meter for glucose monitoring (blood glucose monitoring [BGM] group; n\u2009=\u200979', 'continuous glucose monitoring (CGM', 'Continuous Glucose Monitoring', 'CGM']","['severe hypoglycemia', 'hyperglycemia/ketosis', 'Mean HbA1c', 'additional HbA1c outcomes, CGM glucose metrics, and patient-reported outcomes with adjustment for multiple comparisons to control for the false discovery rate', 'diabetic ketoacidosis', 'glycemic control', 'adverse events', 'change in HbA1c']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0014137', 'cui_str': 'Endocrinology'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0472226', 'cui_str': 'Blood glucose meters'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}]","[{'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0022638', 'cui_str': 'Ketosis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0202048', 'cui_str': 'Glucose measurement by monitoring device'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",3.0,0.108319,"Mean HbA1c was 8.9% at baseline and 8.5% at 26 weeks in the CGM group and 8.9% at both baseline and 26 weeks in the BGM group (adjusted between-group difference, -0.37% [95% CI, -0.66% to -0.08%]; P = .01).","[{'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Laffel', 'Affiliation': 'Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Lauren G', 'Initials': 'LG', 'LastName': 'Kanapka', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Roy W', 'Initials': 'RW', 'LastName': 'Beck', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Bergamo', 'Affiliation': 'University of North Carolina Diabetes Care Center, Chapel Hill.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Clements', 'Affiliation': ""Children's Mercy Hospital, Kansas City, Missouri.""}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Criego', 'Affiliation': 'Health Partners Institute, International Diabetes Center, St Louis Park, Minnesota.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'DeSalvo', 'Affiliation': 'Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Goland', 'Affiliation': 'Naomi Berrie Diabetes Center, Columbia University, New York, New York.'}, {'ForeName': 'Korey', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Stanford University, Palo Alto, California.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Liljenquist', 'Affiliation': 'Rocky Mountain Diabetes & Osteoporosis Center, Idaho Falls, Idaho.'}, {'ForeName': 'Laurel H', 'Initials': 'LH', 'LastName': 'Messer', 'Affiliation': ''}, {'ForeName': 'Roshanak', 'Initials': 'R', 'LastName': 'Monzavi', 'Affiliation': ""Children's Hospital Los Angeles, Los Angeles, California.""}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Mouse', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Prahalad', 'Affiliation': 'Stanford University, Palo Alto, California.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Sherr', 'Affiliation': ""Yale Children's Diabetes Program, New Haven, Connecticut.""}, {'ForeName': 'Jill H', 'Initials': 'JH', 'LastName': 'Simmons', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'R Paul', 'Initials': 'RP', 'LastName': 'Wadwa', 'Affiliation': 'Barbara Davis Center for Childhood Diabetes, Aurora, Colorado.'}, {'ForeName': 'Ruth S', 'Initials': 'RS', 'LastName': 'Weinstock', 'Affiliation': 'SUNY Upstate Medical University, Syracuse, New York.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Willi', 'Affiliation': 'Childrens Hospital of Philadelphia, Philadelphia, Pennsylvania.'}, {'ForeName': 'Kellee M', 'Initials': 'KM', 'LastName': 'Miller', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.6940']
2501,32543684,Effect of Ticagrelor Monotherapy vs Ticagrelor With Aspirin on Major Bleeding and Cardiovascular Events in Patients With Acute Coronary Syndrome: The TICO Randomized Clinical Trial.,"Importance


Discontinuing aspirin after short-term dual antiplatelet therapy (DAPT) was evaluated as a bleeding reduction strategy. However, the strategy of ticagrelor monotherapy has not been exclusively evaluated in patients with acute coronary syndromes (ACS).
Objective


To determine whether switching to ticagrelor monotherapy after 3 months of DAPT reduces net adverse clinical events compared with ticagrelor-based 12-month DAPT in patients with ACS treated with drug-eluting stents.
Design, Setting, and Participants


A randomized multicenter trial was conducted in 3056 patients with ACS treated with drug-eluting stents between August 2015 and October 2018 at 38 centers in South Korea. Follow-up was completed in October 2019.
Interventions


Patients were randomized to receive ticagrelor monotherapy (90 mg twice daily) after 3-month DAPT (n = 1527) or ticagrelor-based 12-month DAPT (n = 1529).
Main Outcomes and Measures


The primary outcome was a 1-year net adverse clinical event, defined as a composite of major bleeding and adverse cardiac and cerebrovascular events (death, myocardial infarction, stent thrombosis, stroke, or target-vessel revascularization). Prespecified secondary outcomes included major bleeding and major adverse cardiac and cerebrovascular events.
Results


Among 3056 patients who were randomized (mean age, 61 years; 628 women [20%]; 36% ST-elevation myocardial infarction), 2978 patients (97.4%) completed the trial. The primary outcome occurred in 59 patients (3.9%) receiving ticagrelor monotherapy after 3-month DAPT and in 89 patients (5.9%) receiving ticagrelor-based 12-month DAPT (absolute difference, -1.98% [95% CI, -3.50% to -0.45%]; hazard ratio [HR], 0.66 [95% CI, 0.48 to 0.92]; P = .01). Of 10 prespecified secondary outcomes, 8 showed no significant difference. Major bleeding occurred in 1.7% of patients with ticagrelor monotherapy after 3-month DAPT and in 3.0% of patients with ticagrelor-based 12-month DAPT (HR, 0.56 [95% CI, 0.34 to 0.91]; P = .02). The incidence of major adverse cardiac and cerebrovascular events was not significantly different between the ticagrelor monotherapy after 3-month DAPT group (2.3%) vs the ticagrelor-based 12-month DAPT group (3.4%) (HR, 0.69 [95% CI, 0.45 to 1.06]; P = .09).
Conclusions and Relevance


Among patients with acute coronary syndromes treated with drug-eluting stents, ticagrelor monotherapy after 3 months of dual antiplatelet therapy, compared with ticagrelor-based 12-month dual antiplatelet therapy, resulted in a modest but statistically significant reduction in a composite outcome of major bleeding and cardiovascular events at 1 year. The study population and lower than expected event rates should be considered in interpreting the trial.
Trial Registration


ClinicalTrials.gov Identifier: NCT02494895.",2020,"The incidence of major adverse cardiac and cerebrovascular events was not significantly different between the ticagrelor monotherapy after 3-month DAPT group (2.3%) vs the ticagrelor-based 12-month DAPT group (3.4%) (HR, 0.69 [95% CI, 0.45 to 1.06]; P = .09).
","['patients with acute coronary syndromes treated with drug-eluting stents', 'Patients', '3056 patients with ACS treated with drug-eluting stents between August 2015 and October 2018 at 38 centers in South Korea', 'patients with acute coronary syndromes (ACS', 'patients with ACS treated with drug-eluting stents', 'With Acute Coronary Syndrome', '3056 patients who were randomized (mean age, 61 years; 628 women [20%]; 36% ST-elevation myocardial infarction), 2978 patients (97.4%) completed the trial']","['DAPT', 'ticagrelor-based 12-month DAPT', 'Ticagrelor Monotherapy vs Ticagrelor', 'Aspirin', 'aspirin', 'ticagrelor monotherapy']","['major bleeding and cardiovascular events', 'Major Bleeding and Cardiovascular Events', 'incidence of major adverse cardiac and cerebrovascular events', 'Major bleeding', 'major bleeding and major adverse cardiac and cerebrovascular events', '1-year net adverse clinical event, defined as a composite of major bleeding and adverse cardiac and cerebrovascular events (death, myocardial infarction, stent thrombosis, stroke, or target-vessel revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",3056.0,0.102151,"The incidence of major adverse cardiac and cerebrovascular events was not significantly different between the ticagrelor monotherapy after 3-month DAPT group (2.3%) vs the ticagrelor-based 12-month DAPT group (3.4%) (HR, 0.69 [95% CI, 0.45 to 1.06]; P = .09).
","[{'ForeName': 'Byeong-Keuk', 'Initials': 'BK', 'LastName': 'Kim', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sung-Jin', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Yun-Hyeong', 'Initials': 'YH', 'LastName': 'Cho', 'Affiliation': 'Myongji Hospital, Hanyang University College of Medicine, Goyang, South Korea.'}, {'ForeName': 'Kyeong Ho', 'Initials': 'KH', 'LastName': 'Yun', 'Affiliation': 'Wonkwang University Hospital, Iksan, South Korea.'}, {'ForeName': 'Yong Hoon', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Kangwon National University School of Medicine, Chuncheon, South Korea.'}, {'ForeName': 'Yongsung', 'Initials': 'Y', 'LastName': 'Suh', 'Affiliation': 'Myongji Hospital, Hanyang University College of Medicine, Goyang, South Korea.'}, {'ForeName': 'Jae Young', 'Initials': 'JY', 'LastName': 'Cho', 'Affiliation': 'Wonkwang University Hospital, Iksan, South Korea.'}, {'ForeName': 'Ae-Young', 'Initials': 'AY', 'LastName': 'Her', 'Affiliation': 'Kangwon National University School of Medicine, Chuncheon, South Korea.'}, {'ForeName': 'Sungsoo', 'Initials': 'S', 'LastName': 'Cho', 'Affiliation': 'Dankook University Hospital, Dankook University College of Medicine, Cheonan, South Korea.'}, {'ForeName': 'Dong Woon', 'Initials': 'DW', 'LastName': 'Jeon', 'Affiliation': 'National Health Insurance Service Ilsan Hospital, Goyang-City, South Korea.'}, {'ForeName': 'Sang-Yong', 'Initials': 'SY', 'LastName': 'Yoo', 'Affiliation': 'Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, South Korea.'}, {'ForeName': 'Deok-Kyu', 'Initials': 'DK', 'LastName': 'Cho', 'Affiliation': 'Yongin Severance Hospital, Yonsei University College of Medicine, Yongin, South Korea.'}, {'ForeName': 'Bum-Kee', 'Initials': 'BK', 'LastName': 'Hong', 'Affiliation': 'Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hyuckmoon', 'Initials': 'H', 'LastName': 'Kwon', 'Affiliation': 'Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Chul-Min', 'Initials': 'CM', 'LastName': 'Ahn', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Dong-Ho', 'Initials': 'DH', 'LastName': 'Shin', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Chung-Mo', 'Initials': 'CM', 'LastName': 'Nam', 'Affiliation': 'Department of Preventive Medicine and Biostatistics, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jung-Sun', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Young-Guk', 'Initials': 'YG', 'LastName': 'Ko', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Donghoon', 'Initials': 'D', 'LastName': 'Choi', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Myeong-Ki', 'Initials': 'MK', 'LastName': 'Hong', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Yangsoo', 'Initials': 'Y', 'LastName': 'Jang', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.7580']
2502,32543698,"Association of Religious and Spiritual Factors With Patient-Reported Outcomes of Anxiety, Depressive Symptoms, Fatigue, and Pain Interference Among Adolescents and Young Adults With Cancer.","Importance


The associations of spiritual and religious factors with patient-reported outcomes among adolescents with cancer are unknown.
Objective


To model the association of spiritual and religious constructs with patient-reported outcomes of anxiety, depressive symptoms, fatigue, and pain interference.
Design, Setting, and Participants


This cross-sectional study used baseline data, collected from 2016 to 2019, from an ongoing 5-year randomized clinical trial being conducted at 4 tertiary-referral pediatric medical centers in the US. A total of 366 adolescents were eligible for the clinical trial, and 126 were randomized; participants had to be aged 14 to 21 years at enrollment and be diagnosed with any form of cancer. Exclusion criteria included developmental delay, scoring greater than 26 on the Beck Depression Inventory II, non-English speaking, or unaware of cancer diagnosis.
Exposures


Spiritual experiences, values, and beliefs; religious practices; and overall self-ranking of spirituality's importance.
Main Outcomes and Measures


Variables were taken from the Brief Multidimensional Measurement of Religiousness/Spirituality (ie, feeling God's presence, daily prayer, religious service attendance, being very religious, and being very spiritual) and the spiritual well-being subscales of the Functional Assessment of Chronic Illness Therapy (meaning/peace and faith). Predefined outcome variables were anxiety, depressive symptoms, fatigue, and pain interference from Patient-Reported Outcomes Measurement Information System pediatric measures.
Results


A total of 126 individuals participated (72 [57.1%] female participants; 100 [79.4%] white participants; mean [SD] age, 16.9 [1.9] years). Structural equation modeling showed that meaning and peace were inversely associated with anxiety (β = -7.94; 95% CI, -12.88 to -4.12), depressive symptoms (β = -10.49; 95% CI, -15.92 to -6.50), and fatigue (β = -8.90; 95% CI, -15.34 to -3.61). Feeling God's presence daily was indirectly associated with anxiety (β = -3.37; 95% CI, -6.82 to -0.95), depressive symptoms (β = -4.50; 95% CI, -8.51 to -1.40), and fatigue (β = -3.73; 95% CI, -8.03 to -0.90) through meaning and peace. Considering oneself very religious was indirectly associated with anxiety (β = -2.81; 95% CI, -6.06 to -0.45), depressive symptoms (β = -3.787; 95% CI, -7.68 to -0.61), and fatigue (β = -3.11, 95% CI, -7.31 to -0.40) through meaning and peace. Considering oneself very spiritual was indirectly associated with anxiety (β = 2.11; 95% CI, 0.05 to 4.95) and depression (β = 2.8, 95% CI, 0.07 to 6.29) through meaning and peace. No associations were found between spiritual scales and pain interference.
Conclusions and Relevance


In this study, multiple facets of spirituality and religiousness were associated with anxiety, depression, and fatigue, all of which were indirectly associated with the participant's sense of meaning and peace, which is a modifiable process. Although these results do not establish a causal direction, they do suggest palliative interventions addressing meaning-making, possibly including a spiritual or religious dimension, as a novel focus for intervention development.",2020,"Considering oneself very spiritual was indirectly associated with anxiety (β = 2.11; 95% CI, 0.05 to 4.95) and depression (β = 2.8, 95% CI, 0.07 to 6.29) through meaning and peace.","['Exclusion criteria included developmental delay, scoring greater than 26 on the Beck Depression Inventory II, non-English speaking, or unaware of cancer diagnosis', 'Adolescents and Young Adults With Cancer', 'A total of 126 individuals participated (72 [57.1%] female participants; 100 [79.4%] white participants; mean [SD] age, 16.9 [1.9] years', '366 adolescents were eligible for the clinical trial, and 126 were randomized; participants had to be aged 14 to 21 years at enrollment and be diagnosed with any form of cancer', '4 tertiary-referral pediatric medical centers in the US', 'adolescents with cancer']",[],"['spiritual scales and pain interference', 'anxiety, depressive symptoms, fatigue, and pain interference', 'anxiety, depression, and fatigue', ""Exposures\n\n\nSpiritual experiences, values, and beliefs; religious practices; and overall self-ranking of spirituality's importance"", 'Anxiety, Depressive Symptoms, Fatigue, and Pain Interference', 'Brief Multidimensional Measurement of Religiousness/Spirituality ', 'fatigue (β', 'anxiety (β', ""ie, feeling God's presence, daily prayer, religious service attendance, being very religious, and being very spiritual) and the spiritual well-being subscales of the Functional Assessment of Chronic Illness Therapy (meaning/peace and faith"", 'depressive symptoms (β', 'depressive symptoms', 'anxiety, depressive symptoms, fatigue, and pain interference from Patient-Reported Outcomes Measurement Information System pediatric measures']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0424605', 'cui_str': 'Developmental delay'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517517', 'cui_str': '1.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}]",[],"[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0557075', 'cui_str': 'Has religious belief'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0699794', 'cui_str': 'Rank'}, {'cui': 'C0237104', 'cui_str': 'Spirituality'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0687003', 'cui_str': 'Religiousness'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392356', 'cui_str': 'Prayer'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0021428', 'cui_str': 'Information system'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",366.0,0.208723,"Considering oneself very spiritual was indirectly associated with anxiety (β = 2.11; 95% CI, 0.05 to 4.95) and depression (β = 2.8, 95% CI, 0.07 to 6.29) through meaning and peace.","[{'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Grossoehme', 'Affiliation': ""Rebecca D. Considine Research Institute, Akron Children's Hospital, Akron, Ohio.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Friebert', 'Affiliation': ""Rebecca D. Considine Research Institute, Akron Children's Hospital, Akron, Ohio.""}, {'ForeName': 'Justin N', 'Initials': 'JN', 'LastName': 'Baker', 'Affiliation': ""Division of Quality of Life and Palliative Care, Department of Oncology, St Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Tweddle', 'Affiliation': ""Chaplaincy Services, Akron Children's Hospital, Akron, Ohio.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Needle', 'Affiliation': 'Division of Pediatric Critical Care Medicine, University of Minnesota Health, Minneapolis.'}, {'ForeName': 'Jody', 'Initials': 'J', 'LastName': 'Chrastek', 'Affiliation': 'Pediatric Palliative Care, University of Minnesota Health-Fairview, Minneapolis.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Thompkins', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's National Hospital, Washington, DC.""}, {'ForeName': 'Jichuan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Division of Biostatistics and Study Methodology, Center for Translational Research at Children's National Research Institute, Washington, DC.""}, {'ForeName': 'Yao I', 'Initials': 'YI', 'LastName': 'Cheng', 'Affiliation': ""Division of Biostatistics and Study Methodology, Center for Translational Research at Children's National Research Institute, Washington, DC.""}, {'ForeName': 'Maureen E', 'Initials': 'ME', 'LastName': 'Lyon', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's National Hospital, Washington, DC.""}]",JAMA network open,['10.1001/jamanetworkopen.2020.6696']
2503,32537430,The impact of an inclusive education intervention on learning outcomes for girls with disabilities within a resource-poor setting.,"Background


Despite a global commitment to the right to education for persons with disabilities, little is known about how to achieve inclusive education in practice, particularly in low- and middle-income countries (LMICs), where the majority of the world's people with disabilities reside. Moreover, although exclusion from education is magnified by intersecting gender and socioeconomic inequalities, there is especially little knowledge regarding what approaches to inclusive education are effective amongst girls with disabilities living in resource-poor settings.
Objectives


The objective of this article was to assess the impact of an inclusive education intervention led by a non-governmental organisation (NGO) on the educational attainment of girls with disabilities in the resource-poor Lakes region of Kenya.
Method


A quasi-experimental design was employed, where the literacy and numeracy educational attainment of the intervention and control groups was compared over two time points a year apart (Time 1 and Time 2; total matched  N  = 353). During this period, activities pertaining to six core components of a holistic inclusive education model were implemented.
Results


Relative to the control group, girls with disabilities in the intervention group reported a greater increase in literacy and numeracy attainment, adjusted for grade and level of functional difficulty.
Conclusion


Findings suggest that the intervention was successful in engendering additional improvements in the educational attainment of girls with disabilities from the resource-poor Lakes region of Kenya. Results highlight both the applicability of NGO-led interventions in settings, where national implementation of inclusive education is constrained, and the potential of taking such interventions to scale.",2020,"Relative to the control group, girls with disabilities in the intervention group reported a greater increase in literacy and numeracy attainment, adjusted for grade and level of functional difficulty.
","['girls with disabilities in the resource-poor Lakes region of Kenya', 'girls with disabilities within a resource-poor setting', 'persons with disabilities', 'girls with disabilities living in resource-poor settings', 'girls with disabilities from the resource-poor Lakes region of Kenya']","['inclusive education intervention led by a non-governmental organisation (NGO', 'inclusive education intervention']","['learning outcomes', 'literacy and numeracy attainment, adjusted for grade and level of functional difficulty']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0337049', 'cui_str': 'Lake'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0557305', 'cui_str': 'Educated at mainstream school'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0029237', 'cui_str': 'Organization'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",,0.0274807,"Relative to the control group, girls with disabilities in the intervention group reported a greater increase in literacy and numeracy attainment, adjusted for grade and level of functional difficulty.
","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Carew', 'Affiliation': 'Leonard Cheshire, London, United Kingdom.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Deluca', 'Affiliation': 'Leonard Cheshire, London, United Kingdom.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Groce', 'Affiliation': 'UCL International Disability Research Centre, London, United Kingdom.'}, {'ForeName': 'Sammy', 'Initials': 'S', 'LastName': 'Fwaga', 'Affiliation': 'Leonard Cheshire, London, United Kingdom.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kett', 'Affiliation': 'UCL International Disability Research Centre, London, United Kingdom.'}]",African journal of disability,['10.4102/ajod.v9i0.555']
2504,32537457,Anthocyanin-Rich New Zealand Blackcurrant Extract Supports the Maintenance of Forearm Blood-Flow During Prolonged Sedentary Sitting.,"Objectives:  We examined the acute effects of anthocyanin-rich New Zealand blackcurrant extract and a placebo on hemodynamics during 120 min of sedentary sitting in healthy males. Additionally, we investigated whether changes in resting hemodynamics altered repeated isometric hand-grip exercise performance and post exercise forearm blood flow (FBF).  Methods:  Ten healthy males completed two trials during which they ingested either blackcurrant extract (1.87 mg total anthocyanins/kg bodyweight) or placebo powder. Heart rate, blood pressure and forearm blood flow were measured, and venous blood was sampled, prior to and 30, 60, 90 and 120 min-post ingestion. Participants remained seated for the duration of each trial. At 120 min post-ingestion participants completed as many repetitions of isometric hand-grip contractions as possible.  Results:  Heart rate, blood pressure and mean arterial pressure changed over time (all  p  < 0.001) but did not differ between treatments. A treatment x time interaction for FBF ( p  = 0.025) and forearm vascular resistance (FVR) ( p  = 0.002) was found. No difference in the number of isometric hand-grip contractions was observed between treatments ( p  = 0.68) nor was there any treatment x time interaction in post-exercise FBF ( p  = 0.997). Plasma endothelin-1 ( p  = 0.023) and nitrate ( p  = 0.047) changed over time but did not differ between treatments (both  p  > 0.1). Plasma nitrite did not change over time ( p  = 0.732) or differ between treatments ( p  = 0.373).  Conclusion:  This study demonstrated that acute ingestion of a single dose of blackcurrant extract maintained FBF and FVR during an extended period of sitting; however, this did not influence exercise performance during hand-grip exercise.",2020,"Results:  Heart rate, blood pressure and mean arterial pressure changed over time (all  p  < 0.001) but did not differ between treatments.","['hemodynamics during 120 min of sedentary sitting in healthy males', 'Ten healthy males completed two trials during which they ingested either']","['blackcurrant extract (1.87 mg total anthocyanins/kg bodyweight) or placebo powder', 'blackcurrant extract maintained FBF and FVR', 'Anthocyanin-Rich New Zealand Blackcurrant Extract', 'anthocyanin-rich New Zealand blackcurrant extract and a placebo']","['Heart rate, blood pressure and forearm blood flow', 'Plasma nitrite', 'Plasma endothelin-1', 'resting hemodynamics altered repeated isometric hand-grip exercise performance and post exercise forearm blood flow (FBF', 'forearm vascular resistance (FVR', 'Forearm Blood-Flow', 'Heart rate, blood pressure and mean arterial pressure changed over time', 'number of isometric hand-grip contractions']","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0453277', 'cui_str': 'Blackcurrants'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0042380', 'cui_str': 'Vascular resistance, function'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}]",10.0,0.19068,"Results:  Heart rate, blood pressure and mean arterial pressure changed over time (all  p  < 0.001) but did not differ between treatments.","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Barnes', 'Affiliation': 'School of Sport, Exercise and Nutrition, Massey University, Palmerston North, New Zealand.'}, {'ForeName': 'Blake G', 'Initials': 'BG', 'LastName': 'Perry', 'Affiliation': 'School of Health Sciences, Massey University, Wellington, New Zealand.'}, {'ForeName': 'Roger D', 'Initials': 'RD', 'LastName': 'Hurst', 'Affiliation': 'The New Zealand Institute for Plant and Food Research Ltd, Palmerston North, New Zealand.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Lomiwes', 'Affiliation': 'The New Zealand Institute for Plant and Food Research Ltd, Palmerston North, New Zealand.'}]",Frontiers in nutrition,['10.3389/fnut.2020.00074']
2505,32537592,An Educational Intervention to Improve the Sleep Behavior and Well-Being of High School Students.,"Objective


The objective of this study was to determine whether a sleep education intervention improves knowledge of sleep, sleep behaviors, and depression in high school freshmen.
Methods


We recruited student volunteers at a single magnet high school in Los Angeles, California through their health class. Twenty-four freshmen participated and 18 students (17 female, 1 male) completed pre- and postsurveys. Curriculum consisted of 4 hours of after-school interactive lectures emphasizing sleep physiology, benefits of sleep, what impacts sleep, and methods to improve sleep, followed by a 9-week sleep behavior change journal. Pre- and postsurveys measuring both sleep behaviors and knowledge, and a Patient Health Questionnaire-9 depression screening were administered to participants prior to and after the intervention. We used  t  tests and  χ   2  tests to analyze knowledge and behavior change.
Results


Subjects improved in average sleep hours per night (preintervention 6.9 hours to postintervention 7.8 hours,  P =.0134), and average weekend night bedtime (11:36 pm to 10:54 pm,  P =.0307).
Conclusions


This school sleep behavior intervention demonstrated students' average sleep hours per night and weekend bedtime improved after the lecture and sleep journal intervention. This suggests a sleep education intervention may benefit this population. Further studies are needed to demonstrate effectiveness of this education over time, across sexes, and in high-risk students.",2019,"Results


Subjects improved in average sleep hours per night (preintervention 6.9 hours to postintervention 7.8 hours,  P =.0134), and average weekend night bedtime (11:36 pm to 10:54 pm,  P =.0307).
","['Twenty-four freshmen participated and 18 students (17 female, 1 male) completed pre- and postsurveys', 'High School Students', 'student volunteers at a single magnet high school in Los Angeles, California through their health class']","['sleep education intervention', 'Educational Intervention']","['average weekend night bedtime', 'knowledge of sleep, sleep behaviors, and depression', 'average sleep hours per night']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0024483', 'cui_str': 'Magnet'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0474396', 'cui_str': 'Sleep behavior finding'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0564385', 'cui_str': '/hour'}]",24.0,0.0263275,"Results


Subjects improved in average sleep hours per night (preintervention 6.9 hours to postintervention 7.8 hours,  P =.0134), and average weekend night bedtime (11:36 pm to 10:54 pm,  P =.0307).
","[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Colt', 'Affiliation': 'Keck School of Medicine of the University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Jo Marie', 'Initials': 'JM', 'LastName': 'Reilly', 'Affiliation': 'Keck School of Medicine of the University of Southern California, Los Angeles, CA.'}]","PRiMER (Leawood, Kan.)",['10.22454/PRiMER.2019.871017']
2506,32537643,Effects of a modestly lower carbohydrate diet in gestational diabetes: a randomized controlled trial.,"BACKGROUND


Lower carbohydrate diets have the potential to improve glycemia but may increase ketonemia in women with gestational diabetes (GDM). We hypothesized that modestly lower carbohydrate intake would not increase ketonemia.
OBJECTIVE


To compare blood ketone concentration, risk of ketonemia, and pregnancy outcomes in women with GDM randomly assigned to a lower carbohydrate diet or routine care.
METHODS


Forty-six women aged (mean ± SEM) 33.3 ± 0.6 y and prepregnancy BMI 26.8 ± 0.9 kg/m2 were randomly assigned at 28.5 ± 0.4 wk to a modestly lower carbohydrate diet (MLC, ∼135 g/d carbohydrate) or routine care (RC, ∼200 g/d) for 6 wk. Blood ketones were ascertained by finger prick test strips and 3-d food diaries were collected at baseline and end of the intervention.
RESULTS


There were no detectable differences in blood ketones between completers in the MLC group compared with the RC group (0.1 ± 0.0 compared with 0.1 ± 0.0 mmol/L, n = 33, P = 0.31, respectively), even though carbohydrate and total energy intake were significantly lower in the intervention group (carbohydrate 165 ± 7 compared with 190 ± 9 g, P = 0.04; energy 7040 ± 240 compared with 8230 ± 320 kJ, P <0.01, respectively). Only 20% of participants in the MLC group met the target intake compared with 65% in the RC group (P <0.01). There were no differences in birth weight, rate of large-for-gestational-age infants, percent fat mass, or fat-free mass between groups.
CONCLUSIONS


An intervention to reduce carbohydrate intake in GDM did not raise ketones to clinical significance, possibly because the target of 135 g/d was difficult to achieve in pregnancy. Feeding studies with food provision may be needed to assess the benefits and risks of low-carbohydrate diets. This trial was registered at www.anzctr.org.au as ACTRN12616000018415.",2020,"There were no differences in birth weight, rate of large-for-gestational-age infants, percent fat mass, or fat-free mass between groups.
","['Forty-six women aged (mean\xa0±\xa0SEM) 33.3\xa0±\xa00.6 y and prepregnancy', 'gestational diabetes', 'women with gestational diabetes (GDM', 'women with GDM randomly assigned to a']","['MLC', 'lower carbohydrate diet or routine care', 'modestly lower carbohydrate diet']","['Blood ketones', 'blood ketones', 'blood ketone concentration, risk of ketonemia, and pregnancy outcomes', 'carbohydrate and total energy intake', 'target intake', 'birth weight, rate of large']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}, {'cui': 'C4517716', 'cui_str': '33.3'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0259836', 'cui_str': 'Carbohydrate restricted diet'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0427750', 'cui_str': 'Ketone concentration, test strip measurement'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0235430', 'cui_str': 'Ketonemia'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0549177', 'cui_str': 'Large'}]",46.0,0.19441,"There were no differences in birth weight, rate of large-for-gestational-age infants, percent fat mass, or fat-free mass between groups.
","[{'ForeName': 'Jovana', 'Initials': 'J', 'LastName': 'Mijatovic', 'Affiliation': 'School of Life and Environmental Sciences, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Jimmy Chun Yu', 'Initials': 'JCY', 'LastName': 'Louie', 'Affiliation': 'School of Biological Sciences, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Marion E C', 'Initials': 'MEC', 'LastName': 'Buso', 'Affiliation': 'Division of Human Nutrition, Wageningen University, Wageningen, The Netherlands.'}, {'ForeName': 'Fiona S', 'Initials': 'FS', 'LastName': 'Atkinson', 'Affiliation': 'School of Life and Environmental Sciences, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Glynis P', 'Initials': 'GP', 'LastName': 'Ross', 'Affiliation': 'Boden Collaboration Central Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Tania P', 'Initials': 'TP', 'LastName': 'Markovic', 'Affiliation': 'Boden Collaboration Central Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Jennie C', 'Initials': 'JC', 'LastName': 'Brand-Miller', 'Affiliation': 'School of Life and Environmental Sciences, The University of Sydney, Sydney, Australia.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa137']
2507,32537688,Additive effect of erythropoietin use on exercise-induced endothelial activation and hypercoagulability in athletes.,"PURPOSE


Recombinant human erythropoietin (rHuEPO) is known to increase thrombotic risk in patients and might have similar effects in athletes abusing the drug. rHuEPO is prohibited by anti-doping legislation, but this risk has not been investigated thoroughly. This analysis was designed to evaluate whether rHuEPO impacts hemostatic profile and endothelial and platelet activation markers in trained subjects, and whether the combination with exercise affects exercise induced alterations.
METHODS


This double-blind, randomized, placebo-controlled trial enrolled healthy, trained male cyclists aged 18-50 years. Participants were randomly allocated (1:1) to receive subcutaneous injections of rHuEPO (epoetin-β; mean dose 6000 IU per week) or placebo (0.9% NaCl) for 8 weeks. Subjects performed five maximal exercise tests and a road race, coagulation and endothelial/platelet markers were measured at rest and directly after each exercise effort.
RESULTS


rHuEPO increased P-selectin (+ 7.8% (1.5-14.5), p = 0.02) and E-selectin (+ 8.6% (2.0-15.7), p = 0.01) levels at rest. Maximal exercise tests significantly influenced all measured coagulation and endothelial/platelet markers, and in the rHuEPO group maximal exercise tests led to 15.3% ((7.0-24.3%), p = 0.0004) higher E-selectin and 32.1% ((4.6-66.8%), p = 0.0207) higher Platelet factor 4 (PF4) levels compared to the placebo group.
CONCLUSION


In conclusion, rHuEPO treatment resulted in elevated E- and P-selectin levels in trained cyclists, indicating enhanced endothelial activation and/or platelet reactivity. Exercise itself induces hypercoagulability, and the combination of rHuEPO and exercise increased E-selectin and PF4 levels more than either intervention alone. Based on this, exercise potentially increases thrombotic risk, a risk that might be enhanced in combination with rHuEPO use.",2020,"Maximal exercise tests significantly influenced all measured coagulation and endothelial/platelet markers, and in the rHuEPO group maximal exercise tests led to 15.3% ((7.0-24.3%), p = 0.0004) higher E-selectin and 32.1% ((4.6-66.8%), p = 0.0207) higher Platelet factor 4 (PF4) levels compared to the placebo group.
","['athletes', 'trained subjects', 'controlled trial enrolled healthy, trained male cyclists aged 18-50\xa0years']","['Recombinant human erythropoietin (rHuEPO', 'subcutaneous injections of rHuEPO (epoetin-β; mean dose 6000\xa0IU per week) or placebo', 'rHuEPO', 'erythropoietin', 'placebo']","['thrombotic risk', 'rHuEPO increased P-selectin', 'endothelial activation and/or platelet reactivity', 'coagulation and endothelial/platelet markers', 'Platelet factor 4 (PF4) levels', 'E-selectin and PF4 levels', 'Maximal exercise tests', 'elevated E- and P-selectin levels']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3842326', 'cui_str': '6000'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0134835', 'cui_str': 'Lymphocyte antigen CD62'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0032183', 'cui_str': 'Platelet factor 4'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0115305', 'cui_str': 'Lymphocyte antigen CD62E'}, {'cui': 'C0522872', 'cui_str': 'Platelet factor 4 assay'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.148786,"Maximal exercise tests significantly influenced all measured coagulation and endothelial/platelet markers, and in the rHuEPO group maximal exercise tests led to 15.3% ((7.0-24.3%), p = 0.0004) higher E-selectin and 32.1% ((4.6-66.8%), p = 0.0207) higher Platelet factor 4 (PF4) levels compared to the placebo group.
","[{'ForeName': 'Jules A A C', 'Initials': 'JAAC', 'LastName': 'Heuberger', 'Affiliation': 'Centre for Human Drug Research, Zernikedreef 8, 2333 CL, Leiden, The Netherlands. jheuberger@chdr.nl.'}, {'ForeName': 'Jelle J', 'Initials': 'JJ', 'LastName': 'Posthuma', 'Affiliation': 'Departments of Internal Medicine and Biochemistry, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Ziagkos', 'Affiliation': 'Centre for Human Drug Research, Zernikedreef 8, 2333 CL, Leiden, The Netherlands.'}, {'ForeName': 'Joris I', 'Initials': 'JI', 'LastName': 'Rotmans', 'Affiliation': 'Department of Internal Medicine, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Johannes M A', 'Initials': 'JMA', 'LastName': 'Daniels', 'Affiliation': 'Department of Pulmonary Diseases, VU University Medical Centre, Amsterdam, The Netherlands.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Gal', 'Affiliation': 'Centre for Human Drug Research, Zernikedreef 8, 2333 CL, Leiden, The Netherlands.'}, {'ForeName': 'Frederik E', 'Initials': 'FE', 'LastName': 'Stuurman', 'Affiliation': 'Centre for Human Drug Research, Zernikedreef 8, 2333 CL, Leiden, The Netherlands.'}, {'ForeName': 'Henri M H', 'Initials': 'HMH', 'LastName': 'Spronk', 'Affiliation': 'Departments of Internal Medicine and Biochemistry, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Ten Cate', 'Affiliation': 'Departments of Internal Medicine and Biochemistry, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Jacobus', 'Initials': 'J', 'LastName': 'Burggraaf', 'Affiliation': 'Centre for Human Drug Research, Zernikedreef 8, 2333 CL, Leiden, The Netherlands.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Moerland', 'Affiliation': 'Centre for Human Drug Research, Zernikedreef 8, 2333 CL, Leiden, The Netherlands.'}, {'ForeName': 'Adam F', 'Initials': 'AF', 'LastName': 'Cohen', 'Affiliation': 'Centre for Human Drug Research, Zernikedreef 8, 2333 CL, Leiden, The Netherlands.'}]",European journal of applied physiology,['10.1007/s00421-020-04419-0']
2508,32537707,Can cognitive-motor training improve physical functioning and psychosocial wellbeing in nursing home residents? A randomized controlled feasibility study as part of the PROCARE project.,"BACKGROUND


A multi-component training program holds promises for the elderly, but still has to be tested on its feasibility and effect in nursing homes.
AIMS


The aim of this study was (1) to design a multi-component training program which improves physical functioning and psychosocial wellbeing and (2) to evaluate the feasibility of this intervention in nursing home residents.
METHODS


This study is a two-arm, stratified-randomized controlled feasibility trail. Twenty-four nursing home residents (aged 83.7 ± 6.4, 21 women) were divided into an intervention and a waiting-list control group. The intervention group completed a multi-component training (including dual-task, dynamic balance, endurance and strength exercises) for 16 weeks (twice per week for 45-60 min). Primary outcomes were lower extremity functionality (SPPB), gait performance (GAITRite), health-related quality of life (SF-12) as well as life satisfaction (SWLS).
RESULTS


Life satisfaction (SWLS) and physical functioning (SPPB) increased in the intervention group after training whereas the control group showed a decrease. Gait parameters could only be analyzed for n = 5 participants of the intervention group and n = 2 of the control group and showed no time differences for the intervention group. The mean number of participants was 12.5 ± 1.9 per session (attendance ranged between 66% and 90%).
CONCLUSION


A multi-component training seems (1) to lead to clinically relevant improvements in physical functioning as well as in psychosocial wellbeing and (2) to be feasible and well accepted in nursing home residents. Nevertheless, the complexity and progression of the program as well as the testing protocol have to be adapted. Further research should test the effectiveness of this adapted program in a larger sample size.",2020,Gait parameters could only be analyzed for n = 5 participants of the intervention group and n = 2 of the control group and showed no time differences for the intervention group.,"['Twenty-four nursing home residents (aged 83.7\u2009±\u20096.4, 21 women', 'nursing home residents']","['cognitive-motor training', 'multi-component training (including dual-task, dynamic balance, endurance and strength exercises', 'multi-component training program', 'waiting-list control group']","['Gait parameters', 'physical functioning and psychosocial wellbeing', 'Life satisfaction (SWLS) and physical functioning (SPPB', 'lower extremity functionality (SPPB), gait performance (GAITRite), health-related quality of life (SF-12) as well as life satisfaction (SWLS']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",,0.0234644,Gait parameters could only be analyzed for n = 5 participants of the intervention group and n = 2 of the control group and showed no time differences for the intervention group.,"[{'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Bischoff', 'Affiliation': 'Institute of Human Movement Science, University of Hamburg, Mollerstraße 10, 20148, Hamburg, Germany. laura.bischoff@uni-hamburg.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Cordes', 'Affiliation': 'Institute of Human Movement Science, University of Hamburg, Mollerstraße 10, 20148, Hamburg, Germany.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Meixner', 'Affiliation': 'Institute of Human Movement Science, University of Hamburg, Mollerstraße 10, 20148, Hamburg, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schoene', 'Affiliation': 'Institute of Medical Physics, Friedrich-Alexander University, Erlangen-Nuernberg, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Voelcker-Rehage', 'Affiliation': 'Institute of Sport and Exercise Sciences, University of Muenster, Muenster, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Wollesen', 'Affiliation': 'Institute of Human Movement Science, University of Hamburg, Mollerstraße 10, 20148, Hamburg, Germany.'}]",Aging clinical and experimental research,['10.1007/s40520-020-01615-y']
2509,32537711,"Early Discontinuation versus Continuation of Antimicrobial Therapy in Low Risk Pediatric Cancer Patients with Febrile Neutropenia, Before Recovery of Counts: A Randomized Controlled Trial (DALFEN Study).","OBJECTIVE


To determine if early discontinuation of antimicrobials in pediatric patients with low risk febrile neutropenia is as effective as continuing therapy before recovery of counts, in an outpatient setting.
METHODS


In an open label, non-inferiority, randomized controlled phase 3 trial at a tertiary cancer center, patients aged 3-18 y, with low risk febrile neutropenia were started on empirical intra-venous antibiotics in an outpatient setting. Randomization was done when the patients became afebrile for at least 24 h; standard arm consisted of oral antibiotics, while antibiotics were stopped in the experimental arm. Enrolled patients were followed for re-appearance of fever and rate of re-admission, until ANC ≥ 500. A pilot feasibility randomized study with similar design preceded this trial.
RESULTS


From Jan 2017-Dec 2018, 75 patients were randomized: 38 to stoppage arm while 37 patients received oral antibiotics. Baseline characteristics were equally matched. Success rates were 94.6% in the continuation arm vs. 94.7% in the stoppage arm; absolute risk difference was 0.1% (95% CI: -10.0% to +10.3%), thus suggesting that the experimental arm is non-inferior to the standard arm. There was no re-admission on failure in any arm.
CONCLUSIONS


Antimicrobial therapy in low risk afebrile neutropenic patients can be stopped early. This approach can lead to significant cost and resource benefits.",2020,"Success rates were 94.6% in the continuation arm vs. 94.7% in the stoppage arm; absolute risk difference was 0.1% (95% CI: -10.0% to +10.3%), thus suggesting that the experimental arm is non-inferior to the standard arm.","['Enrolled patients were followed for re-appearance of fever and rate of re-admission, until ANC\u2009≥', 'pediatric patients with low risk febrile neutropenia', 'patients aged 3-18 y, with low risk febrile neutropenia were started on empirical intra-venous antibiotics in an outpatient setting', 'From Jan 2017-Dec 2018', 'Low Risk Pediatric Cancer Patients with Febrile Neutropenia, Before Recovery of Counts', 'low risk afebrile neutropenic patients', '75 patients were randomized: 38 to stoppage arm while 37 patients received']","['Antimicrobial therapy', 'oral antibiotics', 'Antimicrobial Therapy']",['Success rates'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0277797', 'cui_str': 'Apyrexial'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]",[],75.0,0.227333,"Success rates were 94.6% in the continuation arm vs. 94.7% in the stoppage arm; absolute risk difference was 0.1% (95% CI: -10.0% to +10.3%), thus suggesting that the experimental arm is non-inferior to the standard arm.","[{'ForeName': 'Akash', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Department of Medical Oncology, Dr. BRA IRCH, AIIMS, New Delhi, India.'}, {'ForeName': 'Bivas', 'Initials': 'B', 'LastName': 'Biswas', 'Affiliation': 'Department of Medical Oncology, Dr. BRA IRCH, AIIMS, New Delhi, India.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Chopra', 'Affiliation': 'Department of Lab Oncology, Dr. BRA IRCH, AIIMS, New Delhi, India.'}, {'ForeName': 'Arti', 'Initials': 'A', 'LastName': 'Kapil', 'Affiliation': 'Department of Microbiology, AIIMS, New Delhi, India.'}, {'ForeName': 'Sreenivas', 'Initials': 'S', 'LastName': 'Vishnubhatla', 'Affiliation': 'Department of Biostatistics, AIIMS, New Delhi, India.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Bakhshi', 'Affiliation': 'Department of Medical Oncology, Dr. BRA IRCH, AIIMS, New Delhi, India. sambakh@hotmail.com.'}]",Indian journal of pediatrics,['10.1007/s12098-020-03377-x']
2510,32537812,Impact of clinical pharmacy recommendations and patient counselling program among patients with diabetes and cancer in outpatient oncology setting.,"INTRODUCTION


The simultaneous occurrence of diabetes and cancer may complicate the management of both conditions resulting in poor prognosis and more deterioration of patient-related outcomes.
OBJECTIVE


To assess the effective provision of clinical pharmacy services and pharmacist-led counselling program on improving patient-related outcomes among patients with diabetes and newly diagnosed with cancer during chemotherapy administration.
METHODS


A single-centre, prospective, randomised, controlled study was carried out on patients with diabetes newly diagnosed with cancer during chemotherapy administration at the outpatient oncology setting. Patients were assigned as a normal care group receiving only normal care by the oncology care providers and an intervention group receiving both normal and clinical pharmacy care through an extensive oral and written patient education, pharmacotherapy optimisation and regular recommendations for diabetic self-care activities with three-month follow-up.
RESULTS


Patients within the intervention group showed a better glycaemic control (p = .049), a significant increase in medication adherence (p = .0049), a significant increase in diabetes self-care activities, including diet (p = .037), self-monitoring of blood glucose (p = .027) and foot care (p = .0085) and reported a lower deterioration in quality of life.
CONCLUSION


Patients with diabetes and cancer receiving chemotherapy experienced improved patient-related outcomes after clinical pharmacy intervention and counselling program compared to the normal care group.",2020,"RESULTS


Patients within the intervention group showed a better glycaemic control (p = .049), a significant increase in medication adherence (p = .0049), a significant increase in diabetes self-care activities, including diet (p = .037), self-monitoring of blood glucose (p = .027) and foot care (p = .0085) and reported a lower deterioration in quality of life.
","['patients with diabetes newly diagnosed with cancer during chemotherapy administration at the outpatient oncology setting', 'patients with diabetes and newly diagnosed with cancer during chemotherapy administration', 'Patients with diabetes and cancer receiving', 'patients with diabetes and cancer in outpatient oncology setting']","['clinical pharmacy services and pharmacist-led counselling program', 'normal care group receiving only normal care by the oncology care providers and an intervention group receiving both normal and clinical pharmacy care through an extensive oral and written patient education, pharmacotherapy optimisation and regular recommendations for diabetic self-care activities with three-month follow-up', 'chemotherapy', 'patient counselling program']","['quality of life', 'self-monitoring of blood glucose', 'diabetes self-care activities, including diet', 'foot care', 'glycaemic control', 'medication adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0008968', 'cui_str': 'Clinical Pharmacy Service'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0600047', 'cui_str': 'Patient counseled'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0150240', 'cui_str': 'Foot care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",,0.0391738,"RESULTS


Patients within the intervention group showed a better glycaemic control (p = .049), a significant increase in medication adherence (p = .0049), a significant increase in diabetes self-care activities, including diet (p = .037), self-monitoring of blood glucose (p = .027) and foot care (p = .0085) and reported a lower deterioration in quality of life.
","[{'ForeName': 'Anmar', 'Initials': 'A', 'LastName': 'Al-Taie', 'Affiliation': 'Faculty of Pharmacy, Pharmacy Department, Girne American University, Kyrenia, North Cyprus, Turkey.'}, {'ForeName': 'Fikret V', 'Initials': 'FV', 'LastName': 'Izzettin', 'Affiliation': 'Faculty of Pharmacy, Clinical Pharmacy Department, Bezmialem Vakıf University, Istanbul, Turkey.'}, {'ForeName': 'Mesut', 'Initials': 'M', 'LastName': 'Sancar', 'Affiliation': 'Faculty of Pharmacy, Clinical Pharmacy Department, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Aygül', 'Initials': 'A', 'LastName': 'Köseoğlu', 'Affiliation': 'Oncology Centre, Dr. Lütfi Kırdar Kartal Teaching and Research Hospital, Istanbul, Turkey.'}]",European journal of cancer care,['10.1111/ecc.13261']
2511,32537853,Authors' reply re: Laparoscopic ablation or excision with helium thermal coagulator versus electrodiathermy for the treatment of mild-to-moderate endometriosis: randomised controlled trial.,,2020,,['mild-to-moderate endometriosis'],['Laparoscopic ablation or excision with helium thermal coagulator versus electrodiathermy'],[],"[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0018880', 'cui_str': 'Helium'}]",[],,0.0726803,,"[{'ForeName': 'Gourab', 'Initials': 'G', 'LastName': 'Misra', 'Affiliation': 'Maternity Unit, University Hospitals of North Midlands, Royal Stoke University Hospital, Staffordshire, UK.'}, {'ForeName': 'Julius', 'Initials': 'J', 'LastName': 'Sim', 'Affiliation': 'School of Primary, Community and Social Care, Keele University, Staffordshire, UK.'}, {'ForeName': 'Keira', 'Initials': 'K', 'LastName': 'Watts', 'Affiliation': 'Research and Innovation, University Hospitals of North Midlands, Royal Stoke University Hospital, Staffordshire, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Coia', 'Affiliation': 'Maternity Unit, University Hospitals of North Midlands, Royal Stoke University Hospital, Staffordshire, UK.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16333']
2512,32537887,Secondary analyses to assess the profound effects of empagliflozin on endothelial function in patients with type 2 diabetes and established cardiovascular diseases: The placebo-controlled double-blind randomized effect of empagliflozin on endothelial function in cardiovascular high risk diabetes mellitus: Multi-center placebo-controlled double-blind randomized trial.,"AIMS/INTRODUCTION


Recent clinical trials on sodium-glucose cotransporter 2 inhibitors showed improved outcomes in patients with type 2 diabetes at a high risk of cardiovascular events. However, the underlying effects on endothelial function remain unclear.
MATERIALS AND METHODS


The effect of empagliflozin on endothelial function in cardiovascular high risk diabetes mellitus: Multi-center placebo-controlled double-blind randomized (EMBLEM) trial in patients with type 2 diabetes and cardiovascular disease showed empagliflozin treatment for 24 weeks had no effect on peripheral endothelial function measured by reactive hyperemia peripheral arterial tonometry. This post-hoc analysis of the EMBLEM trial included a detailed evaluation of the effects of empagliflozin on peripheral endothelial function in order to elucidate the clinical characteristics of responders or non-responders to treatment.
RESULTS


Of the 47 patients randomized into the empagliflozin group, 21 (44.7%) showed an increase in the reactive hyperemia index (RHI) after 24 weeks of intervention, with no apparent difference in the clinical characteristics between patients whose RHI either increased (at least >0) or did not increase. There was also no obvious difference between the treatment groups in the proportion of patients who had a clinically meaningful change (≥15%) in log-transformed RHI. No correlation was found between changes in RHI and clinical variables, such as vital signs and laboratory parameters.
CONCLUSIONS


Treatment with empagliflozin for 24 weeks in patients with type 2 diabetes and cardiovascular disease did not affect peripheral endothelial function, and was not related to changes in clinical variables, including glycemic parameters. These findings suggest that the actions of sodium-glucose cotransporter 2 inhibitors other than direct improvement in peripheral endothelial function were responsible, at least in the early phase, for the clinical benefits found in recent cardiovascular outcome trials.",2020,"No correlation was found between changes in RHI and clinical variables, such as vital signs and laboratory parameters.
","['cardiovascular high risk diabetes mellitus', 'patients with type\xa02 diabetes and cardiovascular disease showed', 'patients with type\xa02 diabetes and established cardiovascular diseases', 'patients with type\xa02 diabetes at a high risk of cardiovascular events']","['Multi-center placebo', 'empagliflozin', 'placebo']","['endothelial function', 'reactive hyperemia peripheral arterial tonometry', 'peripheral endothelial function', 'reactive hyperemia index (RHI', 'RHI and clinical variables, such as vital signs and laboratory parameters']","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0040420', 'cui_str': 'Tonometry'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",47.0,0.253742,"No correlation was found between changes in RHI and clinical variables, such as vital signs and laboratory parameters.
","[{'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Tanaka', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Shimabukuro', 'Affiliation': 'Department of Diabetes, Endocrinology, and Metabolism, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Noritaka', 'Initials': 'N', 'LastName': 'Machii', 'Affiliation': 'Department of Diabetes, Endocrinology, and Metabolism, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Teragawa', 'Affiliation': 'Department of Cardiovascular Medicine, JR Hiroshima Hospital, Hiroshima, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Okada', 'Affiliation': 'First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Kosuke R', 'Initials': 'KR', 'LastName': 'Shima', 'Affiliation': 'Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Japan.'}, {'ForeName': 'Toshinari', 'Initials': 'T', 'LastName': 'Takamura', 'Affiliation': 'Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Taguchi', 'Affiliation': 'Department of Cardiology, Dokkyo Medical University Saitama Medical Center, Koshigaya, Japan.'}, {'ForeName': 'Itaru', 'Initials': 'I', 'LastName': 'Hisauchi', 'Affiliation': 'Department of Cardiology, Dokkyo Medical University Saitama Medical Center, Koshigaya, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Toyoda', 'Affiliation': 'Department of Cardiovascular Medicine, Dokkyo Medical University School of Medicine, Tochigi, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Matsuzawa', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Tomiyama', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Minako', 'Initials': 'M', 'LastName': 'Yamaoka-Tojo', 'Affiliation': 'Department of Rehabilitation, Kitasato University School of Allied Health Sciences, Sagamihara, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Ueda', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, University of the Ryukyus, Nishihara, Japan.'}, {'ForeName': 'Yukihito', 'Initials': 'Y', 'LastName': 'Higashi', 'Affiliation': 'Department of Cardiovascular Regeneration and Medicine, Research Institute for Radiation Biology and Medicine, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Node', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan.'}]",Journal of diabetes investigation,['10.1111/jdi.13289']
2513,32218561,Prognostic indicators for poor outcomes in low back pain patients consulted in primary care.,"BACKGROUND


Non-specific low back pain (NSLBP) is the most prevalent musculoskeletal condition in western countries and is associated with persistent disability and high consumption of health care resources. NSLBP patients first seek primary health care services but the outcomes are often uncertain. This study aimed to examine the clinical course of the outcomes and to identify prognostic indicators for poor outcomes in NSLBP patients who consulted primary care.
METHODS


A prospective cohort study of 115 patients seeking treatment for NSLBP in primary care was conducted. Participants were consecutively recruited by their General Practitioners (GPs) and then assessed at baseline and 2 and 6 months later. Baseline assessment included socio-demographic and clinical data, psychosocial factors, pain, disability, and health related quality of life (HRQoL). Pain, disability, HRQoL and global perception of change were also assessed at 2 and 6-months' follow-up. In addition, information regarding the GP' practice was collected. Poor outcomes were determined according to the cut-off point used to define a persistent disabling condition and the minimal important change established for disability, pain and for global perception of change. The relationship between variables on baseline and poor outcomes was modulated through binary logistic regression analysis. The significance of associations was evaluated at ≤ 0.05 p-value with 95% confidence intervals (CI) and adjusted odds ratios (AOR).
RESULTS


110 (94.8%) and 104 (89.7%) participants completed the follow-up assessment at 2 and 6 months, respectively. The mean age (±SD) was 48.06 ± 11.41, with 53.9%, (N = 62) reporting an acute presentation of NSLBP. Six months after GP consultation, 53.8% (N = 56) of the participants reported a persistent disabling condition. An ""LBP episode of less than 12 weeks"" [AOR: 0.26; 95% CI (0.10, 0.65); AOR: 0.34; 95% CI (0.14, 0.81); AOR: 0.21; 95% CI (0.09, 0.53)],""maladaptive psychosocial factors"" [AOR: 2.06; 95% CI (1.40, 3.04); AOR: 1.82; 95% CI (1.27, 2.59); AOR: 1.72; 95% CI (1.20, 2.47)] were significantly associated with poor outcomes on disability, pain and global perception of change, respectively. Besides these factors, being employed reduces the chances of poor outcomes on disability [AOR 0.31; 95% CI (0.11, 0.92)].
CONCLUSIONS


A large proportion of LBP patients seeking primary health care reported poor outcomes 6 months after GP consultation. Patients who report chronic LBP, maladaptive psychosocial factors and are unemployed have a significant increase in the risk of poor outcome. These findings suggest the need of implementing effective models of care able to provide early screening and appropriate treatment to those at greatest risk of a poor outcome.
TRIAL REGISTRATION


Current Controlled Trials NCT04046874 (August 6, 2019). Retrospectively registered.",2020,"An ""LBP episode of less than 12 weeks"" [AOR: 0.26; 95% CI (0.10, 0.65); AOR: 0.34; 95% CI (0.14, 0.81); AOR: 0.21; 95% CI (0.09, 0.53)],""maladaptive psychosocial factors"" [AOR: 2.06; 95% CI (1.40, 3.04); AOR: 1.82; 95% CI (1.27, 2.59); AOR: 1.72; 95% CI (1.20, 2.47)] were significantly associated with poor outcomes on disability, pain and global perception of change, respectively.","['115 patients seeking treatment for NSLBP in primary care', 'The mean age (±SD) was 48.06 ± 11.41, with 53.9%, (N = 62) reporting an acute presentation of NSLBP', 'Participants were consecutively recruited by their General Practitioners (GPs) and then assessed at baseline and 2 and 6 months later', 'NSLBP patients who consulted primary care', 'low back pain patients consulted in primary care']",['NSLBP'],"['socio-demographic and clinical data, psychosocial factors, pain, disability, and health related quality of life (HRQoL', 'disability, pain and global perception', 'persistent disabling condition', 'disability, pain and for global perception of change', 'Pain, disability, HRQoL and global perception of change']","[{'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]","[{'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",115.0,0.126317,"An ""LBP episode of less than 12 weeks"" [AOR: 0.26; 95% CI (0.10, 0.65); AOR: 0.34; 95% CI (0.14, 0.81); AOR: 0.21; 95% CI (0.09, 0.53)],""maladaptive psychosocial factors"" [AOR: 2.06; 95% CI (1.40, 3.04); AOR: 1.82; 95% CI (1.27, 2.59); AOR: 1.72; 95% CI (1.20, 2.47)] were significantly associated with poor outcomes on disability, pain and global perception of change, respectively.","[{'ForeName': 'Eduardo B', 'Initials': 'EB', 'LastName': 'Cruz', 'Affiliation': 'Physiotherapy Department, Setúbal Polytechnic Institute, Setúbal, Portugal.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Canhão', 'Affiliation': 'Comprehensive Health Research Center, CHRC, Lisbon, Portugal.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Fernandes', 'Affiliation': 'Physiotherapy Department, Setúbal Polytechnic Institute, Setúbal, Portugal.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Caeiro', 'Affiliation': 'Physiotherapy Department, Setúbal Polytechnic Institute, Setúbal, Portugal.'}, {'ForeName': 'Jaime C', 'Initials': 'JC', 'LastName': 'Branco', 'Affiliation': 'EpiDoC Unit, CEDOC, NOVA Medical School, Lisbon, Portugal.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Rodrigues', 'Affiliation': 'Comprehensive Health Research Center, CHRC, Lisbon, Portugal.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Pimentel-Santos', 'Affiliation': 'EpiDoC Unit, CEDOC, NOVA Medical School, Lisbon, Portugal.'}, {'ForeName': 'Luís A', 'Initials': 'LA', 'LastName': 'Gomes', 'Affiliation': 'Physiotherapy Department, Setúbal Polytechnic Institute, Setúbal, Portugal.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Paiva', 'Affiliation': 'Physiotherapy Department, Setúbal Polytechnic Institute, Setúbal, Portugal.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Pinto', 'Affiliation': 'ACES Arrábida, The Regional Health Administration of Lisbon and Tagus Valley, Lisbon and Tagus Valley, Portugal.'}, {'ForeName': 'Rubina', 'Initials': 'R', 'LastName': 'Moniz', 'Affiliation': 'ACES Arrábida, The Regional Health Administration of Lisbon and Tagus Valley, Lisbon and Tagus Valley, Portugal.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Nunes', 'Affiliation': 'Comprehensive Health Research Center, CHRC, Lisbon, Portugal.'}]",PloS one,['10.1371/journal.pone.0229265']
2514,32544846,"A fructose-based meal challenge to assess metabotypes and their metabolic risk profile: A randomized, crossover, controlled trial.","OBJECTIVES


The first aim of this study was to determine the metabolic type of individuals based on the postprandial metabolic response after the ingestion of a meal challenge that was high protein and either high glucose (high GI) or fructose (low GI). The second aim was to compare the baseline characteristics between the different metabolic types (metabotypes). The third aim was to assess whether the inclusion of fructose or glucose in a high-protein breakfast modulated the glucose, insulin, and TG response over a 4-h period.
METHODS


The study included 46 Asian women with a body mass index between 17 and 28 kg/m 2  in a randomized crossover design. Metabolic typing was based on the assessment of the postprandial glycemic, insulin and triacylglycerol (TG) response after the ingestion of two high-protein meal challenges either high in fructose or glucose. Baseline characteristics were compared between the different metabolic types. Baseline and 4-h postprandial blood samples were collected and glucose, insulin, and TG levels were analyzed. Cluster analysis was used to phenotype the participants in distinct groups. Baseline characteristics including anthropometry, glycemic, and lipid profiles and resting metabolic rate were compared among the metabolic types.
RESULTS


Cluster analysis revealed that women could be grouped into three metabolic types based on postprandial glucose, insulin, and TG response after the fructose meal challenge: cluster 1 with an average glucose + high TG response (highTG; n = 12), cluster 2 with a high glucose + average TG response (highGLU; n = 8), and cluster 3 with an average glucose + average TG response (Avg; n = 26). Post hoc analysis revealed significantly greater waist-to-hip ratio and a worse lipid profile for the highTG cluster and a higher fasting blood glucose, body mass index, fat percentage, and hip circumference in the highGLU cluster.
CONCLUSIONS


Three metabolic types with a distinct metabolic response could be distinguished after a high fructose meal. The results suggest a different risk profile and may indicate why some people develop diabetes in an obesogenic environment. Improved metabolic-type assessments will enable us to develop and optimize nutritional and medical interventions for individuals with differing diabetes risk.",2020,"Post hoc analysis revealed significantly greater waist-to-hip ratio and a worse lipid profile for the highTG cluster and a higher fasting blood glucose, body mass index, fat percentage, and hip circumference in the highGLU cluster.
","['46 Asian women with a body mass index between 17 and 28 kg/m 2', 'individuals with differing diabetes risk']","['high glucose (high GI) or fructose (low GI', 'fructose-based meal challenge']","['waist-to-hip ratio', 'fasting blood glucose, body mass index, fat percentage, and hip circumference', 'glucose, insulin, and TG levels', 'glucose, insulin, and TG response', 'postprandial glycemic, insulin and triacylglycerol (TG) response', 'Baseline and 4-h postprandial blood samples', 'postprandial glucose, insulin, and TG response', 'anthropometry, glycemic, and lipid profiles and resting metabolic rate', 'postprandial metabolic response']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0860803', 'cui_str': 'Glucose increased'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}]",46.0,0.0341195,"Post hoc analysis revealed significantly greater waist-to-hip ratio and a worse lipid profile for the highTG cluster and a higher fasting blood glucose, body mass index, fat percentage, and hip circumference in the highGLU cluster.
","[{'ForeName': 'Stefan Gerardus', 'Initials': 'SG', 'LastName': 'Camps', 'Affiliation': 'Singapore Institute of Food and Biotechnology Innovation, Agency for Science, Technology and Research and National University Health System, Singapore.'}, {'ForeName': 'Huann Rong', 'Initials': 'HR', 'LastName': 'Koh', 'Affiliation': 'Singapore Institute of Food and Biotechnology Innovation, Agency for Science, Technology and Research and National University Health System, Singapore.'}, {'ForeName': 'Nan Xin', 'Initials': 'NX', 'LastName': 'Wang', 'Affiliation': 'Singapore Institute of Food and Biotechnology Innovation, Agency for Science, Technology and Research and National University Health System, Singapore.'}, {'ForeName': 'Christiani Jeyakumar', 'Initials': 'CJ', 'LastName': 'Henry', 'Affiliation': 'Singapore Institute of Food and Biotechnology Innovation, Agency for Science, Technology and Research and National University Health System, Singapore; Department of Biochemistry, Yong Loo Lin School of Medicine, National University of Singapore, Singapore. Electronic address: jeya_henry@sifbi.a-star.edu.sg.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110799']
2515,32544854,Effect of ZNF804A gene polymorphism (rs1344706) on the plasticity of the functional coupling between the right dorsolateral prefrontal cortex and the contralateral hippocampal formation.,"ZNF804A has now been recognized as a schizophrenia risk gene by multiple genome-wide association studies with its intronic polymorphism rs1344706 being reported as the first genome-wide significant risk variant for schizophrenia. Although the functional impact of this gene is still unknown, rs1344706's contribution to the functional coupling between the right dorsolateral prefrontal cortex (DLPFC) and the contralateral hippocampal formation (HF) has been reported by several studies. The current study tested whether the right DLPFC-left HF functional coupling showed plasticity during cognitive training (Study I) and whether rs1344706 affected the plasticity (Study II). In Study I, we conducted a randomized controlled trial with 30 subjects receiving 20 sessions of adaptive training on a memory span task (the training group) and 30 subjects practicing on a non-adaptive easy version of the same memory span task for 20 sessions (the control group). All subjects were scanned using fMRI before and after the training. Analyses of resting-state and task-state fMRI data consistently showed that the adaptive memory span training significantly strengthened the right DLPFC-left HF functional coupling. In Study II, we conducted a genetic association study with 101 subjects (combining the data from the training group in Study I with those from an additional subsequent sample of 71 subjects who received the same training and fMRI scans). Results showed that rs1344706 was significantly associated with training-induced changes in functional coupling. Subjects carrying the non-risk allele (C) of rs1344706 showed greater training-induced plasticity than the risk allele (A) homozygotes. These findings expanded our current understanding of the functional impact of the schizophrenia risk variant of ZNF804A gene and suggested that the ZNF804A gene could be used as a prospective target for future antipsychotic drugs and clinical research.",2020,Subjects carrying the non-risk allele (C) of rs1344706 showed greater training-induced plasticity than the risk allele (A) homozygotes.,"['101 subjects (combining the data from the training group in Study', '71 subjects who received the same training and fMRI scans', '30 subjects receiving 20 sessions of adaptive training on a memory span task (the training group) and 30 subjects practicing on a non-adaptive easy version of the same memory span task for 20 sessions (the control group']","['ZNF804A', 'ZNF804A gene polymorphism (rs1344706']",['functional coupling'],"[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}]",101.0,0.0118036,Subjects carrying the non-risk allele (C) of rs1344706 showed greater training-induced plasticity than the risk allele (A) homozygotes.,"[{'ForeName': 'Wan', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Xiongying', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders & Beijing Institute for Brain Disorders Center of Schizophrenia, Beijing Anding Hospital, Capital Medical University, Beijing 100088, PR China.'}, {'ForeName': 'Qiumei', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China; School of Mental Health, Jining Medical University, 45# Jianshe South Road, Jining 272013, Shandong Province, PR China.'}, {'ForeName': 'Boqi', 'Initials': 'B', 'LastName': 'Du', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Xiaoxiang', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Ji', 'Affiliation': 'School of Mental Health, Jining Medical University, 45# Jianshe South Road, Jining 272013, Shandong Province, PR China.'}, {'ForeName': 'Yu-Tao', 'Initials': 'YT', 'LastName': 'Xiang', 'Affiliation': 'Faculty of Health Sciences, University of Macau, Avenida da Universidade, Taipa, Macau, PR China.'}, {'ForeName': 'Chuanyue', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders & Beijing Institute for Brain Disorders Center of Schizophrenia, Beijing Anding Hospital, Capital Medical University, Beijing 100088, PR China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Dong', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Chuansheng', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Psychological Science, University of California, Irvine, CA 92697, United States.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China. Electronic address: lijundp@bnu.edu.cn.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102279']
2516,32544914,Feasibility study of a docosahexaenoic acid optimized nutraceutical formulation on the macular levels of lutein in a healthy Mediterranean population.,"INTRODUCTION


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


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


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


From baseline, macular pigment optical density showed significantly higher values in the Lutein/DHA group than in the Lutein group at the end of the study (p<0.0001). Significantly higher Lutein in plasma (p<0.0001) and DHA (p<0.0001) levels in the red blood cell membrane were seen in the Lutein/DHA group than in the Lutein group at the 3-month follow-up.
CONCLUSION


Lutein supplementation improves macular pigment optical density in healthy subjects from a Mediterranean population being significantly increased in the presence of DHA. Therefore, our findings highlight the relevance of the adjunctive role of DHA for a better Lutein availability.",2020,"Significantly higher Lutein in plasma (p<0.0001) and DHA (p<0.0001) levels in the red blood cell membrane were seen in the Lutein/DHA group than in the Lutein group at the 3-month follow-up.
","['One hundred healthy participants (200 eyes) aged 40-70 years (mean age 49.3 years, SEM=13.7', 'healthy Mediterranean population', 'healthy subjects']","['Lutein/DHA', 'Lutein supplementation', 'docosahexaenoic acid optimized nutraceutical formulation', 'lutein', 'Lutein /Docosahexaenoic acid', 'supplementation containing lutein and antioxidant vitamins either with or without docosahexaenoic acid (DHA', 'Lutein']","['macular levels of lutein', 'Lutein in plasma', 'MPOD', 'Lutein in plasma (p<0.0001) and DHA (p<0.0001) levels in the red blood cell membrane', 'macular pigment optical density', 'lutein and DHA levels in plasma and red blood cell membranes respectively']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C1518478', 'cui_str': 'Nutriceuticals'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C3850163', 'cui_str': 'Macular Pigment'}, {'cui': 'C0439164', 'cui_str': 'OD units'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}]",100.0,0.166159,"Significantly higher Lutein in plasma (p<0.0001) and DHA (p<0.0001) levels in the red blood cell membrane were seen in the Lutein/DHA group than in the Lutein group at the 3-month follow-up.
","[{'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Zanon-Moreno', 'Affiliation': ''}, {'ForeName': 'Joan Carles', 'Initials': 'JC', 'LastName': 'Domingo', 'Affiliation': ''}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Sanz Gonzalez', 'Affiliation': ''}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Raga-Cervera', 'Affiliation': ''}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Salazar-Corral', 'Affiliation': ''}, {'ForeName': 'Maria Dolores', 'Initials': 'MD', 'LastName': 'Pinazo-Duran', 'Affiliation': ''}]",Ophthalmic research,['10.1159/000509439']
2517,32544925,Selective kappa-opioid antagonism ameliorates anhedonic behavior: evidence from the Fast-fail Trial in Mood and Anxiety Spectrum Disorders (FAST-MAS).,"Anhedonia remains a major clinical issue for which there is few effective interventions. Untreated or poorly controlled anhedonia has been linked to worse disease course and increased suicidal behavior across disorders. Taking a proof-of-mechanism approach under the auspices of the National Institute of Mental Health FAST-FAIL initiative, we were the first to show that in a transdiagnostic sample screened for elevated self-reported anhedonia, 8 weeks of treatment with a kappa-opioid receptor (KOR) antagonist resulted in significantly higher reward-related activation in one of the core hubs of the brain reward system (the ventral striatum), better reward learning in the Probabilistic Reward Task (PRT), and lower anhedonic symptoms, relative to 8 weeks of placebo. Here, we performed secondary analyses of the PRT data to investigate the putative effects of KOR antagonism on anhedonic behavior with more precision by using trial-level model-based Bayesian computational modeling and probability analyses. We found that, relative to placebo, KOR antagonism resulted in significantly higher learning rate (i.e., ability to learn from reward feedback) and a more sustained preference toward the more frequently rewarded stimulus, but unaltered reward sensitivity (i.e., the hedonic response to reward feedback). Collectively, these findings provide novel evidence that in a transdiagnostic sample characterized by elevated anhedonia, KOR antagonism improved the ability to modulate behavior as a function of prior rewards. Together with confirmation of target engagement in the primary report (Krystal et al., Nat Med, 2020), the current findings suggest that further transdiagnostic investigation of KOR antagonism for anhedonia is warranted.",2020,"We found that, relative to placebo, KOR antagonism resulted in significantly higher learning rate (i.e., ability to learn from reward feedback) and a more sustained preference toward the more frequently rewarded stimulus, but unaltered reward sensitivity (i.e., the hedonic response to reward feedback).",[],"['placebo, KOR antagonism', 'KOR antagonism', 'placebo']","['learning rate (i.e., ability to learn from reward feedback']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0064239', 'cui_str': 'kappa Opioid Receptor'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0233832', 'cui_str': 'Learning ability'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]",,0.0633681,"We found that, relative to placebo, KOR antagonism resulted in significantly higher learning rate (i.e., ability to learn from reward feedback) and a more sustained preference toward the more frequently rewarded stimulus, but unaltered reward sensitivity (i.e., the hedonic response to reward feedback).","[{'ForeName': 'Diego A', 'Initials': 'DA', 'LastName': 'Pizzagalli', 'Affiliation': 'McLean Hospital, Harvard Medical School, Belmont, MA, USA. dap@mclean.harvard.edu.'}, {'ForeName': 'Moria', 'Initials': 'M', 'LastName': 'Smoski', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Yuen-Siang', 'Initials': 'YS', 'LastName': 'Ang', 'Affiliation': 'McLean Hospital, Harvard Medical School, Belmont, MA, USA.'}, {'ForeName': 'Alexis E', 'Initials': 'AE', 'LastName': 'Whitton', 'Affiliation': 'School of Medical Sciences, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Sanacora', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Sanjay J', 'Initials': 'SJ', 'LastName': 'Mathew', 'Affiliation': 'Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Nurnberger', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Lisanby', 'Affiliation': 'National Institute of Mental Health, Bethesda, MD, USA.'}, {'ForeName': 'Dan V', 'Initials': 'DV', 'LastName': 'Iosifescu', 'Affiliation': 'New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Murrough', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Hongqiu', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Weiner', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Calabrese', 'Affiliation': 'Case Western Reserve School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Goodman', 'Affiliation': 'Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'William Z', 'Initials': 'WZ', 'LastName': 'Potter', 'Affiliation': 'National Institute of Mental Health, Bethesda, MD, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Krystal', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0738-4']
2518,32545056,The effect of progressive muscle relaxation on decreasing work stress in air traffic controller.,"OBJECTIVE


This study aims to determine the effect of relaxation on reducing stress levels in Air Traffic Controller (ATC).
METHOD


The study design used quasi experimental research with pre-test post-test control group design. The sample of the research was ATC employees in Makassar Air Traffic Service Center, which amounted to 60 people consisting of 30 people given relaxation therapy interventions and 30 people as a control group. Datacollection using questionnaires and blood pressure measurements. Data collection was done using the stress scale questionnaire (Perceived Stress Scale) and using the job stress NIOSH questionnaire.
RESULTS


The results of the statistical test at the pretest and posttest with the Wilcoxon Sign Rank Test showed a value of z=-2670 and a value of p=0.008 (p<0.05).
CONCLUSION


The conclusion that there were significant differences in work stress between pre-test and post-test in the intervention group, so there was a significant decrease in work stress after being given relaxation therapy.",2020,"The conclusion that there were significant differences in work stress between pre-test and post-test in the intervention group, so there was a significant decrease in work stress after being given relaxation therapy.","['sample of the research was ATC employees in Makassar Air Traffic Service Center, which amounted to 60 people consisting of 30 people given relaxation therapy interventions and 30 people as a control group']","['relaxation', 'progressive muscle relaxation']","['Datacollection using questionnaires and blood pressure measurements', 'stress scale questionnaire (Perceived Stress Scale', 'work stress']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0335205', 'cui_str': 'Air traffic controller'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}]",60.0,0.0169633,"The conclusion that there were significant differences in work stress between pre-test and post-test in the intervention group, so there was a significant decrease in work stress after being given relaxation therapy.","[{'ForeName': 'Lalu Muhammad', 'Initials': 'LM', 'LastName': 'Saleh', 'Affiliation': 'Department of Occupational Health and Safety Faculty of Public Health Hasanuddin University, Indonesia. Electronic address: lalums@unhas.ac.id.'}, {'ForeName': 'Syamsiar S', 'Initials': 'SS', 'LastName': 'Russeng', 'Affiliation': 'Department of Occupational Health and Safety Faculty of Public Health Hasanuddin University, Indonesia.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Awaluddin', 'Affiliation': 'Department of Occupational Health and Safety Faculty of Public Health Hasanuddin University, Indonesia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rum Rahim', 'Affiliation': 'Department of Occupational Health and Safety Faculty of Public Health Hasanuddin University, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.10.080']
2519,32545057,"Correlation of fetal femur length, birth length between IFA and MMN since preconception period.","OBJECTIVE


A short femur length (FL) could be a marker early onset fetal growth restriction. The objective of this study is to know the correlation of fetal femur length and birth length between iron folic acid (IFA) and multimicronutrient (MMN) since preconception period.
METHODS


This randomized double-blind study provided IFA and MMN from preconception period in Banggai District Central Sulawesi. 19 preconception women were followed in their pregnancy to the childbirth. Measurements of fetal size to report are FL (cm) between 22-24 weeks and 37-38 weeks gestation.
RESULTS


The results showed in 2nd trimester of pregnancy mean fetal FL in IFA group=3.70±SD 0.20 in MMN group mean fetal FL=4.18±SD 0.29. In the 3rd trimester of pregnancy in IFA group, mean fetal FL=6.53±SD 0.45 in MMN group mean fetal FL=6.61±SD 0.30. The average length of infants born in IFA group was 47.86cm±2.41 and in MMN group was 49.5cm±2.51. There is no significant correlation of fetal FL in the 2nd and 3rd trimester of pregnancy with the birth length in each group (p>0.05).
CONCLUSION


Women who get IFA intervention has a short FL compared to MMN group. The availability of the nutrients required for optimal fetal growth.",2020,"There is no significant correlation of fetal FL in the 2nd and 3rd trimester of pregnancy with the birth length in each group (p>0.05).
","['19 preconception women', 'Banggai District Central Sulawesi']","['IFA and MMN', 'MMN', 'IFA intervention', 'iron folic acid (IFA) and multimicronutrient (MMN']","['pregnancy mean fetal FL', 'average length', 'fetal FL', 'fetal femur length, birth length']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0376188', 'cui_str': 'Sulawesi'}]","[{'cui': 'C0357067', 'cui_str': 'Folic acid- and iron-containing product'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C1300812', 'cui_str': 'Femur length'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0419415', 'cui_str': 'Birth length'}]",19.0,0.127356,"There is no significant correlation of fetal FL in the 2nd and 3rd trimester of pregnancy with the birth length in each group (p>0.05).
","[{'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Widasari', 'Affiliation': 'Nutrition Department, Medical Faculty, UPN Veteran Jakarta University, Indonesia. Electronic address: drlucywidasari@gmail.com.'}, {'ForeName': 'Maisuri T', 'Initials': 'MT', 'LastName': 'Chalid', 'Affiliation': 'Obstetric and Gynecology Department, Medical School Hasanuddin University, Makassar, Indonesia.'}, {'ForeName': 'Nurhaedar', 'Initials': 'N', 'LastName': 'Jafar', 'Affiliation': 'Faculty of Public Health, Nutritional Sciences, Hasanuddin University, Makassar, Indonesia.'}, {'ForeName': 'Anang', 'Initials': 'A', 'LastName': 'Otoluwa', 'Affiliation': 'Banggai Health District Office, Indonesia.'}, {'ForeName': 'Abdul Razak', 'Initials': 'AR', 'LastName': 'Thaha', 'Affiliation': 'Faculty of Public Health, Nutritional Sciences, Hasanuddin University, Makassar, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.10.075']
2520,32545062,"A comparison between extract Moringa oleifera and iron tablet on prevention low birth weight in pregnant mothers in Makassar, Indonesia.","OBJECTIVE


Compare the effect of Moringa oleifera (MO) leaf extract and iron tablets on pregnant women on low birth weight.
METHODS


This study used a Randomized Double-Blind design controlled by using a sample of non-anemic pregnant women. Birth weight was measured using a digital scale electrically after delivery. Analysis of data using two independent samples t-test.
RESULTS


Overall, there were no significant different between intervention and control group in terms of birth weight (3104.57±52 vs. 3022.29±53g), birth length (48.06±2.4 vs. 48.68±2.6cm), and head circumference (33.72±1.50 vs. 33.55±1.47cm). The number of low birth weight infants in the intervention group of 8.6% and 11.4% of control. There is no difference in birth weight between the intervention with the control group (p=0.365).
CONCLUSION


M. oleifera (MO) leaf extract supplement has similar effect to iron folate supplement in terms of low birth weight incidence. It is recommended for the government to use MO supplement, as local source supplement, replacing iron-folic supplement in improving pregnancy outcomes. A further study is necessary to see the effect of MO supplement to other pregnancy outcomes, including maternal and child mortality.",2020,"There is no difference in birth weight between the intervention with the control group (p=0.365).
","['pregnant mothers in Makassar, Indonesia', 'pregnant women on low birth weight', 'sample of non-anemic pregnant women']","['extract Moringa oleifera and iron tablet', 'M. oleifera (MO) leaf extract supplement', 'Moringa oleifera (MO) leaf extract and iron tablets']","['Birth weight', 'birth length', 'head circumference', 'prevention low birth weight', 'number of low birth weight infants', 'maternal and child mortality', 'birth weight']","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}]","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0949952', 'cui_str': 'Drumsticktree'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0242724', 'cui_str': 'Leaves'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0419415', 'cui_str': 'Birth length'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021288', 'cui_str': 'Low birth weight infant'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008083', 'cui_str': 'Mortality, Child'}]",,0.18582,"There is no difference in birth weight between the intervention with the control group (p=0.365).
","[{'ForeName': '', 'Initials': '', 'LastName': 'Nadimin', 'Affiliation': 'Department of Nutrition, Politeknik Kesehatan Kemenkes Makassar, Indonesia.'}, {'ForeName': 'Veni', 'Initials': 'V', 'LastName': 'Hadju', 'Affiliation': 'Department of Nutrition, School of Public Health, Hasanuddin University, Indonesia.'}, {'ForeName': 'Suryani', 'Initials': 'S', 'LastName': ""As'ad"", 'Affiliation': 'Departmet of Nutrition, School of Medicine, Hasanuddin Univerisity, Indonesia.'}, {'ForeName': 'Agussalim', 'Initials': 'A', 'LastName': 'Bukhari', 'Affiliation': 'Departmet of Nutrition, School of Medicine, Hasanuddin Univerisity, Indonesia.'}, {'ForeName': 'Andi Imam', 'Initials': 'AI', 'LastName': 'Arundhana', 'Affiliation': 'Department of Nutrition, School of Public Health, Hasanuddin University, Indonesia. Electronic address: andiimam.arundhana@gmail.com.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Imrawati', 'Affiliation': 'Sekolah Tinggi Ilmu Farmasi (STIFA) Makassar, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2020.02.008']
2521,32545063,The effect of African leaf herbal tea on fast blood glucose on centration of prediabetes teachers in Makassar city.,"OBJECTIVE


The aims of this study was to determine the effect of giving 14 days of African leaf herbal tea to FBG levels of prediabetes teachers.
METHOD


A quasi-experimental study using the non-randomized pretest posttest method. There were 30 samples. Levels of FBG, Anthropometry and Recall 24-hours collected had been divided into 3 study groups are dose of 2 grams (group I), 4g (group II) and controls.
RESULT


5.3% decreases in FBG levels of group I, 5.6% in group II, and 0.5% increase in FBG levels of control group. There was no significant difference in FBG levels before and after intervention in group I (p=0.057), group II (p=0.252), and control group (p=0.928).
CONCLUSION


Consumption of 4g of African leaf herbal tea for 14 days reduces FBG best. It is recommended to consume African leaf herbal tea to reduce blood glucose levels in patients with prediabetes.",2020,"There was no significant difference in FBG levels before and after intervention in group I (p=0.057), group II (p=0.252), and control group (p=0.928).
","['prediabetes teachers', 'centration of prediabetes teachers in Makassar city', 'patients with prediabetes']",['African leaf herbal tea'],"['blood glucose levels', 'FBG levels', 'FBG best']","[{'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0242724', 'cui_str': 'Leaves'}, {'cui': 'C0019233', 'cui_str': 'Herbal tea'}]","[{'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",,0.025374,"There was no significant difference in FBG levels before and after intervention in group I (p=0.057), group II (p=0.252), and control group (p=0.928).
","[{'ForeName': 'Annisaa Maharani', 'Initials': 'AM', 'LastName': 'Halim', 'Affiliation': 'Department of Nutrition, Faculty of Public Health, Hasanuddin University, Indonesia. Electronic address: amin.gzuh@gmail.com.'}, {'ForeName': 'Saifuddin', 'Initials': 'S', 'LastName': 'Sirajuddin', 'Affiliation': 'Department of Nutrition, Faculty of Public Health, Hasanuddin University, Indonesia.'}, {'ForeName': 'Burhanuddin', 'Initials': 'B', 'LastName': 'Bahar', 'Affiliation': 'Department of Nutrition, Faculty of Public Health, Hasanuddin University, Indonesia.'}, {'ForeName': 'Nurhaedar', 'Initials': 'N', 'LastName': 'Jafar', 'Affiliation': 'Department of Nutrition, Faculty of Public Health, Hasanuddin University, Indonesia.'}, {'ForeName': 'Aminuddin', 'Initials': 'A', 'LastName': 'Syam', 'Affiliation': 'Department of Nutrition, Faculty of Public Health, Hasanuddin University, Indonesia.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Masni', 'Affiliation': 'Department of Biostatistics, Faculty of Public Health, Hasanuddin University, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.10.081']
2522,32545135,Ginger candy (Zingiber officinale) reduces the frequency of vomiting of first-trimester pregnant women with emesis gravidarum.,"OBJECTIVE


This study aimed to determine the effectiveness of ginger candy to reduce the frequency of vomiting in trimester pregnant women.
METHODS


It was a quasi-experimental study with non-randomized pre-test post-test with control group. The subject was divided into three groups of interventions, i.e. ginger candy, placebo, administering vitamin B6. The samples were 51 the first-trimester pregnant mothers that experience the emesis or vomit 3-5times/day, each group consist of 17 pregnant mothers. Intervention was done as long as 7 days.
RESULTS


Data shows that before giving the intervention, all groups experienced vomiting 3-5times/day, i.e. 17 people (100%). There was no difference between the ginger candy, placebo and vitamin B6 groups, but after giving the intervention, there were differences in the frequency of vomiting, the remaining ginger candy groups were 4 people (23.6%) who had a frequency of vomiting 3-5 times/day, while in the group given vitamin B6 there are still 16 people (94.1%). The group was given placebo all subjects, namely, 17 people (100%) still experienced vomiting 5-3 times/day.
CONCLUSION


Ginger candy can reduce the frequency of vomiting in pregnant women with emesis gravidarum.",2020,"There was no difference between the ginger candy, placebo and vitamin B6 groups, but after giving the intervention, there were differences in the frequency of vomiting, the remaining ginger candy groups were 4 people (23.6%) who had a frequency of vomiting 3-5 times/day, while in the group given vitamin B6 there are still 16 people (94.1%).","['trimester pregnant women', '17 pregnant mothers', 'pregnant women with emesis gravidarum', 'of first-trimester pregnant women with emesis gravidarum']","['ginger candy', 'Ginger candy (Zingiber officinale', 'Ginger candy', 'ginger candy, placebo, administering vitamin B6', 'placebo']",['frequency of vomiting'],"[{'cui': 'C0032982', 'cui_str': 'Trimesters'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0032979', 'cui_str': 'First trimester pregnancy'}]","[{'cui': 'C0162751', 'cui_str': 'Ginger'}, {'cui': 'C0006855', 'cui_str': 'Candy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0034272', 'cui_str': 'pyridoxine'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",,0.0799069,"There was no difference between the ginger candy, placebo and vitamin B6 groups, but after giving the intervention, there were differences in the frequency of vomiting, the remaining ginger candy groups were 4 people (23.6%) who had a frequency of vomiting 3-5 times/day, while in the group given vitamin B6 there are still 16 people (94.1%).","[{'ForeName': 'Niska', 'Initials': 'N', 'LastName': 'Anita', 'Affiliation': 'Department of Midwifery, Graduate School, Hasanuddin University of Makassar, Indonesia.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Sartini', 'Affiliation': 'Faculty of Pharmacy Makassar, Hasanuddin University, Indonesia.'}, {'ForeName': 'Gemini', 'Initials': 'G', 'LastName': 'Alam', 'Affiliation': 'Faculty of Pharmacy Makassar, Hasanuddin University, Indonesia. Electronic address: gemini@pasca.unhas.ac.id.'}]",Enfermeria clinica,['10.1016/j.enfcli.2020.03.014']
2523,32545139,Effect of moringa leaves during pregnancy on growth and morbidity in 0-5 months.,"OBJECTIVE


Moringa leaves (ML) has been proved as a nutrient supplement during pregnancy. This study was undertaken to assess the effect of ML on growth and morbidity of infant 0-5mo of age.
METHOD


This study was an intervention study. Subjects were originally pregnant mothers who were divided into three groups: group received ML powder (MLP, n=111), group received ML extract (MLE, n=107), and group received iron folic acid (IFA, n=122). Each group received two capsules a day for 12 weeks during pregnancy and 4 weeks after giving birth. Growth and morbidity measurement were assessed each month during 5mo period. Data was analyzed using Chi-squares.
RESULTS


Study showed that prevalence of under nutrition at the first sixth moths were 2.4%, 3.2%, 6.5%, 7.4%, 9.7%, and 7.9%, respectively for 0-5mo. In addition, the prevalence of stunting were 3.2%, 9.7%, 20.0%, 24.7%, 19.6%, and 19.4%, respectively for 0-5mo. The prevalence of wasting were 5.9%, 5.0%, 2.1%, 2.1%, 2.6%, 3.2% respectively for 0-5mo. Not significantly different among groups in all parameters (p>0.05). Upper respiratory infection was the most infection at the first 6mo (2.06-4.2%).
CONCLUSION


We conclude that ML tends to protect from under nutrition to the infant but not stunting.",2020,Not significantly different among groups in all parameters (p>0.05).,['Subjects were originally pregnant mothers'],"['ML powder (MLP, n=111), group received ML extract (MLE, n=107), and group received iron folic acid', 'ML']","['Upper respiratory infection', 'prevalence of stunting', 'growth and morbidity', 'prevalence of under nutrition', 'Growth and morbidity measurement', 'prevalence of wasting']","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C0969724', 'cui_str': 'Moringa'}, {'cui': 'C0242724', 'cui_str': 'Leaves'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0357067', 'cui_str': 'Folic acid- and iron-containing product'}]","[{'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}]",,0.0391881,Not significantly different among groups in all parameters (p>0.05).,"[{'ForeName': 'Mahmud Nur', 'Initials': 'MN', 'LastName': 'Ulmy', 'Affiliation': 'Postgraduate School Students Faculty of Public Helath, Hasanuddin University, Indonesia; Faculty of Public Health, Universitas Muslim Indonesia, Indonesia. Electronic address: nurulmymahmud@yahoo.com.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Tahir', 'Affiliation': 'Faculty of Public Health, Hasanuddin University, Indonesia.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Arsunan', 'Affiliation': 'Faculty of Public Health, Hasanuddin University, Indonesia.'}, {'ForeName': 'Bahar', 'Initials': 'B', 'LastName': 'Burhanuddin', 'Affiliation': 'Faculty of Public Health, Hasanuddin University, Indonesia.'}, {'ForeName': 'Hadju', 'Initials': 'H', 'LastName': 'Veni', 'Affiliation': 'Faculty of Public Health, Hasanuddin University, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.10.041']
2524,32545143,The effect of moringa leaf extracton increasing hemoglobin and bodyweight in post-disaster pregnant women.,"OBJECTIVE


The purpose of this study was to analyze the effect of extract of Moringa leaves extract to reduce the incidence of anemia by measuring hemoglobin level (Hb), upper arm circumference (UAC) and body weight (BW) on post-disaster pregnant women. It also aimed to determine the effect of moringa leaves extract on Hb level, UAC and BW of pregnant women.
METHOD


This research used a quasi experiment with a randomized controlled double blind design. A sample of 40 pregnant women were divided into two groups, namely the intervention group of 20 people and the control group of 20 people. The intervention group was given capsules of Moringa leaf extract and iron capsules every day. The control group was only given iron capsules.
RESULT


The characteristics of respondents in the two groups before intervention and put it before were not different. To show there is a difference after the intervention, the Hb level of pregnant women in the intervention group significantly increased compared to the control group (p=0.000). Similarly the UAC and BW are higher in intervention group than that in control (p=0.033). This means that the data were significantly different (p=0.040).
CONCLUSION


The conclusion was that moringa leaf extract has an effect on increasing HB level, UAC and BW of post-disaster pregnant women in the area of Tinggede Health Center, Sigi District. Moringa leaf extract is suggested as an alternative supplement to overcome anemia on post-disaster pregnant women.",2020,Similarly the UAC and BW are higher in intervention group than that in control (p=0.033).,"['post-disaster pregnant women', 'disaster pregnant women', '40 pregnant women', 'pregnant women']","['extract of Moringa leaves extract', 'moringa leaves extract', 'capsules of Moringa leaf extract and iron capsules every day', 'moringa leaf extracton']","['UAC and BW', 'hemoglobin and bodyweight', 'HB level, UAC and BW', 'Hb level, UAC and BW', 'incidence of anemia by measuring hemoglobin level (Hb), upper arm circumference (UAC) and body weight (BW']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012618', 'cui_str': 'Disasters'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0969724', 'cui_str': 'Moringa'}, {'cui': 'C0242724', 'cui_str': 'Leaves'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0230348', 'cui_str': 'Both upper arms'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",40.0,0.0403306,Similarly the UAC and BW are higher in intervention group than that in control (p=0.033).,"[{'ForeName': 'Rosmala', 'Initials': 'R', 'LastName': 'Nur', 'Affiliation': 'Public Health Department, Faculty of Public Health, Tadulako University, Palu, Indonesia. Electronic address: rosmalanur.fkm@untad.ac.id.'}, {'ForeName': 'Indah Puspasari Kiyai', 'Initials': 'IPK', 'LastName': 'Demak', 'Affiliation': 'Medicine Department, Faculty of Medicine, Tadulako University, Palu, Indonesia.'}, {'ForeName': 'Sitti', 'Initials': 'S', 'LastName': 'Radhiah', 'Affiliation': 'Public Health Department, Faculty of Public Health, Tadulako University, Palu, Indonesia.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Rusydi', 'Affiliation': 'Geophysics Department, Faculty of Mathematics and Natural Sciences, Tadulako University, Palu, Indonesia.'}, {'ForeName': 'Elvaria', 'Initials': 'E', 'LastName': 'Mantao', 'Affiliation': 'Public Health Department, Faculty of Public Health, Tadulako University, Palu, Indonesia.'}, {'ForeName': 'Rahma Dwi', 'Initials': 'RD', 'LastName': 'Larasati', 'Affiliation': 'Public Health Department, Faculty of Public Health, Tadulako University, Palu, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.10.045']
2525,32545147,Affect of moringa oleifera given against pregnant and breastfeeding mothers cortisol.,"OBJECTIVE


This study to assess the affect of moringa oleifera given against pregnant and breastfeeding mothers cortisol.
METHOD


Sample 40 pregnant women, low education, no work statusin, the experimental method (Randomized Double Blind design), Saliva samples from nursing mothers tested by Laboratory using KIT ELISA.
RESULTS


Pre cortisol in the iron tablet and Moringa flour group was p=0.0003, post pregnancy cortisol results in the iron group and Moringa flour, p=0.119, decrement greater in the group with Moringa flour±SD 2.91±7:20, group of iron±SD 3.60±6:37, based on test of both groups the presence of the value p=0.006, at 3 months of age, p=0.923 (p>0.05) at 6 months of age p=0.496 (p>0.05), a greater decrease occurred in the Moringa flour group with a value of±SD=↓ 5.44±16.77, based on test of both groups the presence of the value p (p=0.359).
CONCLUSION


Moringa flour provides the same benefits as Fe against cortisol levels during pregnancy but not significant at the lactation.",2020,"RESULTS


Pre cortisol in the iron tablet and Moringa flour group was p=0.0003, post pregnancy cortisol results in the iron group and Moringa flour, p=0.119, decrement greater in the group with Moringa flour±SD 2.91±7:20, group of iron±SD 3.60±6:37, based on test of both groups the presence of the value p=0.006, at 3 months of age, p=0.923 (p>0.05) at 6 months of age p=0.496 (p>0.05), a greater decrease occurred in the Moringa flour group with a value of±SD=↓ 5.44±16.77, based on test of both groups the presence of the value p (p=0.359).
","['Sample 40 pregnant women, low education, no work statusin, the experimental method (Randomized Double Blind design), Saliva samples from nursing mothers tested by Laboratory using KIT ELISA', 'pregnant and breastfeeding mothers cortisol']",[],['post pregnancy cortisol results'],"[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}]",[],"[{'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",40.0,0.07958,"RESULTS


Pre cortisol in the iron tablet and Moringa flour group was p=0.0003, post pregnancy cortisol results in the iron group and Moringa flour, p=0.119, decrement greater in the group with Moringa flour±SD 2.91±7:20, group of iron±SD 3.60±6:37, based on test of both groups the presence of the value p=0.006, at 3 months of age, p=0.923 (p>0.05) at 6 months of age p=0.496 (p>0.05), a greater decrease occurred in the Moringa flour group with a value of±SD=↓ 5.44±16.77, based on test of both groups the presence of the value p (p=0.359).
","[{'ForeName': '', 'Initials': '', 'LastName': 'Suhartatik', 'Affiliation': 'Instructor, Poltekkes Kemenkes Makassar, Indonesia. Electronic address: suhartatik2212@gmail.com.'}, {'ForeName': 'Veni', 'Initials': 'V', 'LastName': 'Hadju', 'Affiliation': 'Department of Nutrition, Faculty of Public Health, Hasanuddin University, Indonesia.'}, {'ForeName': 'Masyita', 'Initials': 'M', 'LastName': 'Muis', 'Affiliation': 'Department of Occupational Health and Safety, Public Health Faculty of Hasanuddin University, Indonesia.'}, {'ForeName': 'Hasanuddin', 'Initials': 'H', 'LastName': 'Ishak', 'Affiliation': 'Department of Environmental Health, Public Health Faculty of Hasanuddin University, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.10.048']
2526,32545149,Effect of moringa oleifera cookies to improve quality of breastmilk.,"OBJECTIVE


This study aims to analyze the effect of moringa cookies consumption to improve the quality of breastmilk on exclusive breastfeeding mothers.
METHOD


This was an experimental study with pre and post control group design. The intervention group consumed 50 grams of moringa cookies for a month. The quality of breast milk was measured by analyzing carbohydrate, protein, fat, and vitamin A level. Data were analyzed using independent T-test.
RESULTS


There was an increase in the levels of fat, protein, carbohydrate and vitamin A in breast milk in both the intervention and control groups (fat level in intervention group (2.8587±0.1149) vs control group (2.8694±0.1098), p=0.145; protein level in intervention group (1.5135±0.1566) vs control group (1.5692±0.1343), p=0.029; vitamin A level in intervention group (0.0067±0.0008) vs control group (0.0067±0.0072), p=1.000; carbohydrate level in the intervention group (7.1677±0.5205) vs control group (7.2344±0.6831), p=0.565. Only protein levels increased significantly in the intervention groups compared to the control groups (p<0.05).
CONCLUSION


This study showed that consumption of moringa cookies increase the quality of breast milk especially protein level.",2020,"There was an increase in the levels of fat, protein, carbohydrate and vitamin A in breast milk in both the intervention and control groups (fat level in intervention group (2.8587±0.1149) vs control group (2.8694±0.1098), p=0.145; protein level in intervention group (1.5135±0.1566) vs control group (1.5692±0.1343), p=0.029; vitamin A level in intervention group (0.0067±0.0008) vs control group (0.0067±0.0072), p=1.000; carbohydrate level in the intervention group (7.1677±0.5205) vs control group (7.2344±0.6831), p=0.565.",[],['moringa cookies consumption'],"['levels of fat, protein, carbohydrate and vitamin A in breast milk', 'quality of breast milk', 'quality of breastmilk', 'carbohydrate level', 'protein levels']",[],"[{'cui': 'C0969724', 'cui_str': 'Moringa'}, {'cui': 'C3853210', 'cui_str': 'Cookie'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}]",,0.0183124,"There was an increase in the levels of fat, protein, carbohydrate and vitamin A in breast milk in both the intervention and control groups (fat level in intervention group (2.8587±0.1149) vs control group (2.8694±0.1098), p=0.145; protein level in intervention group (1.5135±0.1566) vs control group (1.5692±0.1343), p=0.029; vitamin A level in intervention group (0.0067±0.0008) vs control group (0.0067±0.0072), p=1.000; carbohydrate level in the intervention group (7.1677±0.5205) vs control group (7.2344±0.6831), p=0.565.","[{'ForeName': '', 'Initials': '', 'LastName': 'Sumarni', 'Affiliation': 'Department of Nutrition, Faculty of Medical, Tadulako University, Indonesia. Electronic address: sumarnidr@gmail.com.'}, {'ForeName': 'Indah', 'Initials': 'I', 'LastName': 'Puspasari', 'Affiliation': 'Department of Public health, Faculty of Medical, Tadulako University, Indonesia.'}, {'ForeName': 'Anwar', 'Initials': 'A', 'LastName': 'Mallongi', 'Affiliation': 'Department of Enviromental Health, Faculty of Public health, Hasanuddin University, Indonesia.'}, {'ForeName': 'Elli', 'Initials': 'E', 'LastName': 'Yane', 'Affiliation': 'Department of Public health, Faculty of Medical, Tadulako University, Indonesia.'}, {'ForeName': 'Ayu', 'Initials': 'A', 'LastName': 'Sekarani', 'Affiliation': 'Department of Parasitology, Faculty of Medical, Tadulako University, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.10.050']
2527,32545150,Clinical efficacy of photodynamic therapy as an adjunct to mechanical debridement in the treatment of per-implantitis with abscess.,"AIM


The aim of the present clinical trial was to evaluate the efficacy of photodynamic therapy (PDT) as an adjunct to mechanical debridement (MD) in the treatment of severe peri-implantitis (PI) with abscess.
MATERIALS AND METHODS


Selected individuals with severe PI were divided into two groups: Group A: received methylene blue mediated (PDT) using diode laser as an adjunct to MD, whereas, Group B received thrice daily application of 500 mg amoxicillin and 400 mg metronidazole with adjunctive MD. Peri-implant plaque scores (PS), probing depth (PD), bleeding on probing (BOP) and clinical attachment loss (CAL) were reported. Microbial counts of Porphyromonas gingivalis, Treponema denticola and Tannerella forsythia were analyzed using polymerase chain reaction. The assessment of pain was done with the help of numeric pain rating scale (NPRS). All assessments were done at baseline and repeated at 6 and 12 months, respectively.
RESULTS


A total of 40 individuals completed the clinical trial. Both Group A and Group B comprised of 20 patients respectively. A significant improvement was observed in BOP in Group A at 12 months compared to Group B. No statistically significant changes were seen for NPRS scores between both groups (p > 0.05). Statistically significant differences were observed in values for P. gingivalis, T. denticola and T. forsythia at 6 months follow-up period in comparison to baseline for both Group A and Group B (p < 0.05). Whereas, the values observed at 6 months follow-up period for Porphyromonas gingivalis also reported a statistically significant difference in between the groups (p < 0.05).
CONCLUSION


PDT was equally effective in reducing severe peri-implant symptoms compared to antimicrobial therapy as an adjunct to mechanical debridement.",2020,"Statistically significant differences were observed in values for P. gingivalis, T. denticola and T. forsythia at 6 months follow-up period in comparison to baseline for both Group A and Group B (p < 0.05).","['40 individuals completed the clinical trial', 'per-implantitis with abscess', 'severe peri-implantitis (PI) with abscess', 'Selected individuals with severe PI']","['metronidazole with adjunctive MD', 'photodynamic therapy (PDT', 'photodynamic therapy', 'amoxicillin', 'methylene blue mediated (PDT) using diode laser as an adjunct to MD', 'mechanical debridement (MD']","['BOP', 'severe peri-implant symptoms', 'values for P. gingivalis, T. denticola and T. forsythia', 'Microbial counts of Porphyromonas gingivalis, Treponema denticola and Tannerella forsythia', 'Peri-implant plaque scores (PS), probing depth (PD), bleeding on probing (BOP) and clinical attachment loss (CAL', 'numeric pain rating scale (NPRS', 'NPRS scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C2936258', 'cui_str': 'Dental peri-implantitis'}]","[{'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1018538', 'cui_str': 'Lian qiao'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0206347', 'cui_str': 'Porphyromonas'}, {'cui': 'C0318222', 'cui_str': 'Treponema denticola'}, {'cui': 'C0314961', 'cui_str': 'Tannerella forsythia'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",40.0,0.0386964,"Statistically significant differences were observed in values for P. gingivalis, T. denticola and T. forsythia at 6 months follow-up period in comparison to baseline for both Group A and Group B (p < 0.05).","[{'ForeName': 'Thamer', 'Initials': 'T', 'LastName': 'Almohareb', 'Affiliation': 'Department of Restorative Dental Sciences, College of Dentistry, King Saud University, Riyadh 11545, Saudi Arabia.'}, {'ForeName': 'Nawaf', 'Initials': 'N', 'LastName': 'Alhamoudi', 'Affiliation': 'Department of Periodontics and Community Dentistry, King Saud University, Riyadh 11545, Saudi Arabia. Electronic address: nalhamoudi@ksu.edu.sa.'}, {'ForeName': 'Modhi', 'Initials': 'M', 'LastName': 'Al Deeb', 'Affiliation': 'Department of Prosthetic Dental Science, College of Dentistry, King Saud University, Riyadh 11545, Saudi Arabia.'}, {'ForeName': 'Mohammed S', 'Initials': 'MS', 'LastName': 'Bin-Shuwaish', 'Affiliation': 'Department of Restorative Dental Sciences, College of Dentistry, King Saud University, Riyadh 11545, Saudi Arabia.'}, {'ForeName': 'Sameer A', 'Initials': 'SA', 'LastName': 'Mokeem', 'Affiliation': 'Department of Periodontics and Community Dentistry, King Saud University, Riyadh 11545, Saudi Arabia.'}, {'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Saad Shafqat', 'Affiliation': 'Medilink Consultant Clinics, Karachi, Pakistan.'}, {'ForeName': 'Fahim', 'Initials': 'F', 'LastName': 'Vohra', 'Affiliation': 'Department of Prosthetic Dental Science, College of Dentistry, King Saud University, Riyadh 11545, Saudi Arabia.'}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Abduljabbar', 'Affiliation': 'Department of Prosthetic Dental Science, College of Dentistry, King Saud University, Riyadh 11545, Saudi Arabia; Research Chair for Biological Research in Dental Health, College of Dentistry, Riyadh 11545, Saudi Arabia.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101750']
2528,32545223,Impact of Molar Furcations on Photodynamic Therapy Outcomes: A 6-Month Split-Mouth Randomized Clinical Trial.,"The effectiveness of adjunctive photodynamic treatment (PDT) to non-surgical periodontal therapy has been shown to depend on initial periodontal status. As molar furcation involvement impairs healing response to non-surgical periodontal therapy, the aim of this study was to evaluate the impact of furcation involvement on PDT outcomes. Thirty-six patients suffering from severe chronic periodontitis were included in a 6-month split-mouth randomized clinical trial. PDT applications used the toluidine blue O and a light-emitting diode (LED) with a red spectrum. Repeated PDT applications were performed in addition to non-surgical periodontal treatment at baseline and at 3-months. Pocket probing depth (PPD), plaque index, bleeding on probing, and clinical attachment level were recorded at baseline, and again at 3- and 6-months. Furcation sites of molars were compared to other sites of molars and non-molars. Multilevel analysis showed no PDT effect in molar furcation sites while an additional significant reduction (odds ratio = 0.67) of pockets with PPD > 5 mm in other sites at 3-months was measured. PPD reduction appeared delayed in molar furcation sites treated with PDT. There is no additional apparent benefit to use PDT in molar furcation sites for the reduction of pockets with PPD > 5 mm contrary to other sites.",2020,There is no additional apparent benefit to use PDT in molar furcation sites for the reduction of pockets with PPD > 5 mm contrary to other sites.,['Thirty-six patients suffering from severe chronic periodontitis'],"['Molar Furcations', 'adjunctive photodynamic treatment (PDT']","['healing response', 'Photodynamic Therapy Outcomes', 'PPD reduction', 'Pocket probing depth (PPD), plaque index, bleeding on probing, and clinical attachment level', 'PDT effect in molar furcation sites']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}]","[{'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0205145', 'cui_str': 'Site'}]",36.0,0.0345002,There is no additional apparent benefit to use PDT in molar furcation sites for the reduction of pockets with PPD > 5 mm contrary to other sites.,"[{'ForeName': 'Aymeric', 'Initials': 'A', 'LastName': 'Courval', 'Affiliation': 'Department of Periodontology, Dental Faculty, University of Strasbourg, 67000 Strasbourg, France.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Harmouche', 'Affiliation': 'Department of Periodontology, Dental Faculty, University of Strasbourg, 67000 Strasbourg, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Mathieu', 'Affiliation': 'Department of Periodontology, Dental Faculty, University of Strasbourg, 67000 Strasbourg, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Petit', 'Affiliation': 'Department of Periodontology, Dental Faculty, University of Strasbourg, 67000 Strasbourg, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Huck', 'Affiliation': 'Department of Periodontology, Dental Faculty, University of Strasbourg, 67000 Strasbourg, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Séverac', 'Affiliation': 'Methodology and Biostatistics Group, Public Health Department, University Hospitals of Strasbourg, 67000 Strasbourg, France.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Davideau', 'Affiliation': 'Department of Periodontology, Dental Faculty, University of Strasbourg, 67000 Strasbourg, France.'}]",International journal of environmental research and public health,['10.3390/ijerph17114162']
2529,32545250,"In ""High-Risk"" Infants with Sufficient Vitamin D Status at Birth, Infant Vitamin D Supplementation Had No Effect on Allergy Outcomes: A Randomized Controlled Trial.","Lower vitamin D status at birth and during infancy has been associated with increased incidence of eczema and food allergies. The aim of this study was to investigate the effect of early infancy vitamin D supplementation on allergic disease outcomes in infants at ""hereditary risk"" of allergic disease, but who had sufficient vitamin D levels at birth. Here, we report the early childhood follow-up to 2.5 years of age of ""high-risk"" infants who participated in a double-blinded, randomized controlled trial. For inclusion in this trial, late gestation (36-40 weeks) maternal 25-hydroxyvitamin D levels needed to be ≥50 nmol/L. Infants were randomized to either oral vitamin D supplementation of 400 IU/day ( n  = 97) or a placebo ( n  = 98) for the first six months of life. Vitamin D levels and allergic disease outcomes were followed up. There were no statistically significant differences in incidence of any medically diagnosed allergic disease outcomes or allergen sensitization rates between the vitamin D-supplemented and placebo groups at either 1 year or at 2.5 years of age. In conclusion, for ""allergy high-risk"" infants who had sufficient vitamin D status at birth, early infancy oral vitamin D supplementation does not appear to reduce the development of early childhood allergic disease.",2020,There were no statistically significant differences in incidence of any medically diagnosed allergic disease outcomes or allergen sensitization rates between the vitamin D-supplemented and placebo groups at either 1 year or at 2.5 years of age.,"['late gestation (36-40 weeks) maternal 25-hydroxyvitamin D levels needed to be ≥50 nmol/L. Infants', 'infants at ""hereditary risk"" of allergic disease, but who had sufficient vitamin D levels at birth', 'early childhood follow-up to 2.5 years of age of ""high-risk"" infants who participated']","['placebo', 'vitamin D-supplemented and placebo', 'oral vitamin D supplementation', 'early infancy vitamin D supplementation']","['Vitamin D levels and allergic disease outcomes', 'allergic disease outcomes', 'incidence of any medically diagnosed allergic disease outcomes or allergen sensitization rates', 'Allergy Outcomes']","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0439282', 'cui_str': 'nmol/L'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439660', 'cui_str': 'Hereditary'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C1325847', 'cui_str': 'Sensitization'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}]",,0.70589,There were no statistically significant differences in incidence of any medically diagnosed allergic disease outcomes or allergen sensitization rates between the vitamin D-supplemented and placebo groups at either 1 year or at 2.5 years of age.,"[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Rueter', 'Affiliation': 'School of Medicine, The University of Western Australia, 35 Stirling Highway, Crawley, WA 6009, Australia.'}, {'ForeName': 'Anderson P', 'Initials': 'AP', 'LastName': 'Jones', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, 15 Hospital Avenue, Nedlands, WA 6009, Australia.'}, {'ForeName': 'Aris', 'Initials': 'A', 'LastName': 'Siafarikas', 'Affiliation': 'School of Medicine, The University of Western Australia, 35 Stirling Highway, Crawley, WA 6009, Australia.'}, {'ForeName': 'Ee-Mun', 'Initials': 'EM', 'LastName': 'Lim', 'Affiliation': 'Department of Endocrinology and Diabetes, Sir Charles Gairdner Hospital, Nedlands, WA 6009, Australia.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Prescott', 'Affiliation': 'School of Medicine, The University of Western Australia, 35 Stirling Highway, Crawley, WA 6009, Australia.'}, {'ForeName': 'Debra J', 'Initials': 'DJ', 'LastName': 'Palmer', 'Affiliation': 'School of Medicine, The University of Western Australia, 35 Stirling Highway, Crawley, WA 6009, Australia.'}]",Nutrients,['10.3390/nu12061747']
2530,32545353,Long-Term Effects in Bone Mineral Density after Different Bariatric Procedures in Patients with Type 2 Diabetes: Outcomes of a Randomized Clinical Trial.,"There is scant evidence of the long-term effects of bariatric surgery on bone mineral density (BMD). We compared BMD changes in patients with severe obesity and type 2 diabetes (T2D) 5 years after randomization to metabolic gastric bypass (mRYGB), sleeve gastrectomy (SG) and greater curvature plication (GCP). We studied the influence of first year gastrointestinal hormone changes on final bone outcomes. Forty-five patients, averaging 49.4 (7.8) years old and body mass index (BMI) 39.4 (1.9) kg/m 2 , were included. BMD at lumbar spine (LS) was lower after mRYGB compared to SG and GCP: 0.89 [0.82;0.94] vs. 1.04 [0.91;1.16] vs. 0.99 [0.89;1.12],  p  = 0.020. A higher percentage of LS osteopenia was present after mRYGB 78.6% vs. 33.3% vs. 50.0%, respectively. BMD reduction was greater in T2D remitters vs. non-remitters. Weight at fifth year predicted BMD changes at the femoral neck (FN) (adjusted  R 2 : 0.3218;  p  = 0.002), and type of surgery (mRYGB) and menopause predicted BMD changes at LS (adjusted  R 2 : 0.2507;  p  < 0.015). In conclusion, mRYGB produces higher deleterious effects on bone at LS compared to SG and GCP in the long-term. Women in menopause undergoing mRYGB are at highest risk of bone deterioration. Gastrointestinal hormone changes after surgery do not play a major role in BMD outcomes.",2020,"BMD at lumbar spine (LS) was lower after mRYGB compared to SG and GCP: 0.89 [0.82;0.94] vs. 1.04 [0.91;1.16] vs. 0.99 [0.89;1.12],  p  = 0.020.","['Forty-five patients, averaging 49.4 (7.8) years old and body mass index (BMI) 39.4 (1.9) kg/m 2 , were included', 'patients with severe obesity and type 2 diabetes (T2D) 5 years after randomization to', 'Patients with Type 2 Diabetes']","['metabolic gastric bypass (mRYGB), sleeve gastrectomy (SG) and greater curvature plication (GCP', 'bariatric surgery']","['BMD at lumbar spine (LS', 'bone deterioration', 'BMD reduction', 'bone mineral density (BMD', 'Bone Mineral Density', 'LS osteopenia', 'type of surgery (mRYGB) and menopause predicted BMD changes']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517517', 'cui_str': '1.9'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0227223', 'cui_str': 'Structure of greater curvature of stomach'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",45.0,0.0884541,"BMD at lumbar spine (LS) was lower after mRYGB compared to SG and GCP: 0.89 [0.82;0.94] vs. 1.04 [0.91;1.16] vs. 0.99 [0.89;1.12],  p  = 0.020.","[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Guerrero-Pérez', 'Affiliation': ""Department of Endocrinology and Nutrition, Bellvitge University Hospital-IDIBELL, L'Hospitalet de Llobregat, 08907 Barcelona, Spain.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Casajoana', 'Affiliation': ""Bariatric Surgery Unit, Bellvitge University Hospital-IDIBELL, L'Hospitalet de Llobregat, 08907 Barcelona, Spain.""}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Gómez-Vaquero', 'Affiliation': ""Department of Rheumatology, Bellvitge University Hospital-IDIBELL, L'Hospitalet de Llobregat, 08907 Barcelona, Spain.""}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Virgili', 'Affiliation': ""Department of Endocrinology and Nutrition, Bellvitge University Hospital-IDIBELL, L'Hospitalet de Llobregat, 08907 Barcelona, Spain.""}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'López-Urdiales', 'Affiliation': ""Department of Endocrinology and Nutrition, Bellvitge University Hospital-IDIBELL, L'Hospitalet de Llobregat, 08907 Barcelona, Spain.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hernández-Montoliu', 'Affiliation': ""Department of Endocrinology and Nutrition, Bellvitge University Hospital-IDIBELL, L'Hospitalet de Llobregat, 08907 Barcelona, Spain.""}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Pujol-Gebelli', 'Affiliation': ""Bariatric Surgery Unit, Bellvitge University Hospital-IDIBELL, L'Hospitalet de Llobregat, 08907 Barcelona, Spain.""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Osorio', 'Affiliation': ""Bariatric Surgery Unit, Bellvitge University Hospital-IDIBELL, L'Hospitalet de Llobregat, 08907 Barcelona, Spain.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Prats', 'Affiliation': ""Clinical Nutrition Unit, Bellvitge University Hospital-IDIBELL, L'Hospitalet de Llobregat, 08907 Barcelona, Spain.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Vidal-Alabró', 'Affiliation': ""Instituto de Investigación Biomédica-IDIBELL, L'Hospitalet de Llobregat, 08907 Barcelona, Spain.""}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Pérez-Maraver', 'Affiliation': ""Department of Endocrinology and Nutrition, Bellvitge University Hospital-IDIBELL, L'Hospitalet de Llobregat, 08907 Barcelona, Spain.""}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Fernández-Veledo', 'Affiliation': 'CIBERDEM-CIBER de Diabetes y Enfermedades Metabólicas Asociadas, Instituto de Salud Carlos III, 28014 Madrid, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Vendrell', 'Affiliation': 'CIBERDEM-CIBER de Diabetes y Enfermedades Metabólicas Asociadas, Instituto de Salud Carlos III, 28014 Madrid, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Vilarrasa', 'Affiliation': ""Department of Endocrinology and Nutrition, Bellvitge University Hospital-IDIBELL, L'Hospitalet de Llobregat, 08907 Barcelona, Spain.""}]",Journal of clinical medicine,['10.3390/jcm9061830']
2531,32545396,"An Assessment of the Glyconutrient Ambrotose™ on Immunity, Gut Health, and Safety in Men and Women: A Placebo-Controlled, Double-Blind, Randomized Clinical Trial.","BACKGROUND


Certain dietary fibers have been reported to improve gut health and cellular immunity. Ambrotose is a glyconutrient supplement that contains mannose-rich polysaccharides (acemannan), reported to improve immune function. A more nutrient-dense version of this dietary supplement has been developed recently, with added aloe leaf gel powder (acemannan). The purpose of this study was to evaluate the impact of the traditional and newly developed Ambrotose products on immunity, gut health, and psychological well-being in healthy men and women.
METHODS


Seventy-five men and women were randomly assigned in double-blind manner to one of five treatments, as follows: Ambrotose Advanced (AA) at 2 or 4 g daily, Ambrotose LIFE (AL) at 2 or 4 g daily, or placebo. Subjects ingested their assigned treatment daily for eight weeks. Resting heart rate, blood pressure, and measures of psychological well-being were analyzed before and after four and eight weeks of supplementation. Blood samples were collected at the same times and analyzed for zonulin, hematology measures, and cytokines-IL-6, IL-10, IL-1β, and TNF-α (analyzed both with and without stimulation via lipopolysaccharide [LPS]).
RESULTS


All Ambrotose treatments were well-tolerated. There were no differences among treatments in heart rate or blood pressure across time. Self-reported well-being scores were generally higher for the Ambrotose treatments but there were no changes of statistical significance across time ( p  > 0.05). Differences of statistical significance were noted for select biochemical variables, the most notable being a dramatic decrease in monocytes in the Ambrotose groups. No change was noted in the cytokine response to LPS stimulation in all groups, indicating a maintenance of a healthy immune response.  Conclusion:  Regular supplementation with Ambrotose is safe and can improve subclinical cellular adversity (as evidenced by a decrease in monocytes), without unnecessary activation of an immune response.",2020,Self-reported well-being scores were generally higher for the Ambrotose treatments but there were no changes of statistical significance across time ( p  > 0.05).,"['Seventy-five men and women', 'healthy men and women', 'Men and Women']","['Regular supplementation with Ambrotose', 'Ambrotose Advanced (AA) at 2 or 4 g daily, Ambrotose LIFE (AL) at 2 or 4 g daily, or placebo', 'Placebo']","['tolerated', 'Resting heart rate, blood pressure, and measures of psychological well-being', 'Self-reported well-being scores', 'immunity, gut health, and psychological well-being', 'Immunity, Gut Health, and Safety', 'zonulin, hematology measures, and cytokines-IL-6, IL-10, IL-1β, and TNF-α', 'heart rate or blood pressure across time', 'cytokine response to LPS stimulation']","[{'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0020964', 'cui_str': 'Immune status'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0914216', 'cui_str': 'zonulin'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]",75.0,0.317622,Self-reported well-being scores were generally higher for the Ambrotose treatments but there were no changes of statistical significance across time ( p  > 0.05).,"[{'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Bloomer', 'Affiliation': 'Center for Nutraceuticals and Dietary Supplement Research, School of Health Studies, 106 Roane Fieldhouse, University of Memphis, Memphis, TN 38152, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Butawan', 'Affiliation': 'Center for Nutraceuticals and Dietary Supplement Research, School of Health Studies, 106 Roane Fieldhouse, University of Memphis, Memphis, TN 38152, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'van der Merwe', 'Affiliation': 'Center for Nutraceuticals and Dietary Supplement Research, School of Health Studies, 106 Roane Fieldhouse, University of Memphis, Memphis, TN 38152, USA.'}, {'ForeName': 'Faith H', 'Initials': 'FH', 'LastName': 'Keating', 'Affiliation': 'Center for Nutraceuticals and Dietary Supplement Research, School of Health Studies, 106 Roane Fieldhouse, University of Memphis, Memphis, TN 38152, USA.'}]",Nutrients,['10.3390/nu12061751']
2532,32545416,Risk Factors for Delayed Neurocognitive Recovery According to Brain Biomarkers and Cerebral Blood Flow Velocity.,"Background and Objectives:  The aim of this study is to identify risk factors for the development of delayed neurocognitive recovery (dNCR).  Methods:  140 patients underwent neurocognitive evaluations (Adenbrooke, MoCa, trial making, and CAM test) and middle cerebral artery (MCA) blood flow velocity (BFV) measurements, one day before cardiac surgery. BFV was re-evaluated after anesthesia induction, before the beginning, middle, end, and after cardiopulmonary bypass (CPB) and postsurgery. To measure glial fibrillary acidic protein (GFAP) and neurofilament heavy chain (Nf-H), blood samples were collected after anesthesia induction, 24 and 48 h after the surgery. Neurocognitive evaluation was repeated 7-10 days after surgery. According to the results, patients were divided into two groups: with dNCR (dNCR group) and without dNCR (non-dNCR group).  Results:  101 patients completed participation in this research. GFAP increased in both the non-dNCR group ( p  < 0.01) and in the dNCR group ( p  < 0.01), but there was no difference between the groups (after 24 h,  p  0.342; after 48 h,  p  0.273). Nf-H increased in both groups ( p  < 0.01), but there was no difference between them (after 24 h,  p  = 0.240; after 48 h,  p  = 0.597). MCA BFV was significantly lower in the dNCR group during the bypass (37.13 cm/s SD 7.70 versus 43.40 cm/s SD 9.56;  p  = 0.001) and after surgery (40.54 cm/s SD 11.21 versus 47.6 cm/s SD 12.01;  p  = 0.003). Results of neurocognitive tests correlated with CO 2  concentration (Pearson's r 0.40,  p  < 0.01), hematocrit (r 0.42,  p  < 0.01), MCA BFV during bypass (r 0.41,  p  < 0.01), and age (r -0.533,  p  < 0.01). The probability of developing dNCR increases 1.21 times with every one year of increased age ( p  < 0.01). The probability of developing dNCR increases 1.07 times with a decrease of BFV within 1 cm/s during bypass ( p  = 0.02 ) .   Conclusion : Risk factors contributing to dNCR among the tested patients were older age and middle cerebral artery blood flow velocity decrease during bypass.",2020,"GFAP increased in both the non-dNCR group ( p  < 0.01) and in the dNCR group ( p  < 0.01), but there was no difference between the groups (after 24 h,  p  0.342; after 48 h,  p  0.273).","['140 patients underwent neurocognitive evaluations (Adenbrooke, MoCa, trial making, and CAM test) and', '101 patients completed participation in this research']","['dNCR (dNCR group) and without dNCR (non-dNCR group', 'dNCR']","['BFV', 'glial fibrillary acidic protein (GFAP) and neurofilament heavy chain (Nf-H), blood samples', 'Delayed Neurocognitive Recovery', 'Brain Biomarkers and Cerebral Blood Flow Velocity', 'hematocrit', 'GFAP', 'Neurocognitive evaluation', 'MCA BFV', 'middle cerebral artery (MCA) blood flow velocity (BFV) measurements']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0017626', 'cui_str': 'Glial fibrillary acidic protein'}, {'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C1505576', 'cui_str': 'NEFH protein, human'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0000325', 'cui_str': '20-Methylcholanthrene'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C0005798', 'cui_str': 'Blood Flow Velocity'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",140.0,0.0362471,"GFAP increased in both the non-dNCR group ( p  < 0.01) and in the dNCR group ( p  < 0.01), but there was no difference between the groups (after 24 h,  p  0.342; after 48 h,  p  0.273).","[{'ForeName': 'Rasa', 'Initials': 'R', 'LastName': 'Bukauskienė', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Lithuanian University of Health Sciences, 50161 Kaunas, Lithuania.'}, {'ForeName': 'Edmundas', 'Initials': 'E', 'LastName': 'Širvinskas', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Lithuanian University of Health Sciences, 50161 Kaunas, Lithuania.'}, {'ForeName': 'Tadas', 'Initials': 'T', 'LastName': 'Lenkutis', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Lithuanian University of Health Sciences, 50161 Kaunas, Lithuania.'}, {'ForeName': 'Rimantas', 'Initials': 'R', 'LastName': 'Benetis', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Lithuanian University of Health Sciences, 50161 Kaunas, Lithuania.'}, {'ForeName': 'Rasa', 'Initials': 'R', 'LastName': 'Steponavičiūtė', 'Affiliation': 'Department of Laboratory Medicine, Lithuanian University of Health Sciences, 50161 Kaunas, Lithuania.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56060288']
2533,32545478,"Effects of Cocoa-Rich Chocolate on Blood Pressure, Cardiovascular Risk Factors, and Arterial Stiffness in Postmenopausal Women: A Randomized Clinical Trial.","This study aimed to evaluate the effects of the intake of 10 g of cocoa-rich chocolate on blood pressure, other cardiovascular risk factors, and vascular structure and function in postmenopausal women. A total of 140 postmenopausal women participated in this randomized and controlled parallel clinical trial. For six months, the intervention group (IG;  n  = 73) consumed daily 10 g of chocolate (99% cocoa) added to their usual food intake, whereas the control group (CG;  n  = 67) did not receive any intervention. Blood pressure, pulse pressure (PP), cardio-ankle vascular index (CAVI), ankle-brachial index (ABI), brachial-ankle pulse wave velocity (baPWV), augmentation index, and laboratory variables were measured at baseline and six months. ANCOVA analyses adjusted for baseline values revealed no significant differences for systolic blood pressure (-1.45 mm Hg; 95% confidence interval (CI): -4.79, 1.88;  p  = 0.391) or baPWV (0.18 m/s; 95% CI: -0.14, 0.50;  p  = 0.263) between groups. A decrease in PP was observed in the IG compared to the CG (-2.05 mm Hg; 95% CI: -4.08, -0.02;  p  = 0.048). The rest of the vascular structure and function parameters and other measured variables remained unchanged. The daily intake of 10 g of cocoa-rich chocolate seems to provide little improvement to cardiovascular health, but neither does it cause any adverse effects on the parameters evaluated in postmenopausal women in the long term.",2020,"A decrease in PP was observed in the IG compared to the CG (-2.05 mm Hg; 95% CI: -4.08, -0.02;  p  = 0.048).","['Postmenopausal Women', 'postmenopausal women', '140 postmenopausal women']","['daily 10 g of chocolate (99% cocoa) added to their usual food intake, whereas the control group (CG;  n  = 67) did not receive any intervention', 'Cocoa-Rich Chocolate', 'cocoa-rich chocolate']","['Blood Pressure, Cardiovascular Risk Factors, and Arterial Stiffness', 'baPWV', 'PP', 'systolic blood pressure', 'Blood pressure, pulse pressure (PP), cardio-ankle vascular index (CAVI), ankle-brachial index (ABI), brachial-ankle pulse wave velocity (baPWV), augmentation index, and laboratory variables', 'blood pressure, other cardiovascular risk factors, and vascular structure and function']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319553', 'cui_str': '140'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C4034558', 'cui_str': 'Cardio-ankle vascular index'}, {'cui': 'C1328319', 'cui_str': 'Ankle brachial pressure index'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0232154', 'cui_str': 'Ankle pulse'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",140.0,0.194294,"A decrease in PP was observed in the IG compared to the CG (-2.05 mm Hg; 95% CI: -4.08, -0.02;  p  = 0.048).","[{'ForeName': 'Irene A', 'Initials': 'IA', 'LastName': 'Garcia-Yu', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL). Servicio de Salud de Castilla y León (SACyL), 37005 Salamanca, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Garcia-Ortiz', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL). Servicio de Salud de Castilla y León (SACyL), 37005 Salamanca, Spain.'}, {'ForeName': 'Manuel A', 'Initials': 'MA', 'LastName': 'Gomez-Marcos', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL). Servicio de Salud de Castilla y León (SACyL), 37005 Salamanca, Spain.'}, {'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Rodriguez-Sanchez', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL). Servicio de Salud de Castilla y León (SACyL), 37005 Salamanca, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Agudo-Conde', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL). Servicio de Salud de Castilla y León (SACyL), 37005 Salamanca, Spain.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Gonzalez-Sanchez', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL). Servicio de Salud de Castilla y León (SACyL), 37005 Salamanca, Spain.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Maderuelo-Fernandez', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL). Servicio de Salud de Castilla y León (SACyL), 37005 Salamanca, Spain.'}, {'ForeName': 'Jose I', 'Initials': 'JI', 'LastName': 'Recio-Rodriguez', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL). Servicio de Salud de Castilla y León (SACyL), 37005 Salamanca, Spain.'}]",Nutrients,['10.3390/nu12061758']
2534,32545534,"Self-Regulation in Children with Neurodevelopmental Disorders ""SR-MRehab: Un Colegio Emocionante"": A Protocol Study.","Self-regulation refers to the ability to control and modulate behavior, and it can include both emotional and cognitive modulation. Children with neurodevelopmental disorders may show difficulties in self-regulation. The main objective of this study is to improve self-regulation skills in children between 6 and 11 years of age with neurodevelopmental disorders. Methodology: A randomized controlled trial will be conducted with the use of ""SR-MRehab: Un colegio emocionante"", based on a non-immersive virtual reality system where virtual objects can be managed by children in a natural way using their hands. Children will be recruited from several schools of Granada (Spain) and they will be randomly allocated to two groups. An assessment will be conducted before and after the intervention and 24 weeks after the end of the intervention process. The experimental group will receive the intervention using virtual reality. The control group will receive a standard self-regulation program. Both interventions will be performed once a week for a total of 10 sessions. Changes in self-regulation, as well as the acceptability of technology with the use of SR-MRehab, will be evaluated. The results will be published and will provide evidence regarding the use of this type of intervention in children with neurodevelopmental disorders. Trial registration: Registered with code NCT04418921.",2020,"Changes in self-regulation, as well as the acceptability of technology with the use of SR-MRehab, will be evaluated.","['children with neurodevelopmental disorders', 'Children with neurodevelopmental disorders', 'children between 6 and 11 years of age with neurodevelopmental disorders', 'Children with Neurodevelopmental Disorders', 'Children will be recruited from several schools of Granada (Spain']","['standard self-regulation program', 'SR-MRehab', 'Methodology']",['self-regulation skills'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1535926', 'cui_str': 'Neurodevelopmental disorder'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0969625', 'cui_str': 'methodology'}]","[{'cui': 'C0684274', 'cui_str': 'Self-control'}]",,0.0449342,"Changes in self-regulation, as well as the acceptability of technology with the use of SR-MRehab, will be evaluated.","[{'ForeName': 'Dulce', 'Initials': 'D', 'LastName': 'Romero-Ayuso', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy Division, Faculty of Health Sciences, University of Granada, Avda. De la Ilustración nº60, 18016 Granada, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Alcántara-Vázquez', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy Division, Faculty of Health Sciences, University of Granada, Avda. De la Ilustración nº60, 18016 Granada, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Almenara-García', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy Division, Faculty of Health Sciences, University of Granada, Avda. De la Ilustración nº60, 18016 Granada, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Nuñez-Camarero', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy Division, Faculty of Health Sciences, University of Granada, Avda. De la Ilustración nº60, 18016 Granada, Spain.'}, {'ForeName': 'José Matías', 'Initials': 'JM', 'LastName': 'Triviño-Juárez', 'Affiliation': 'Primary Care Center Zaidín Sur, Granada Metropolitan Sanitary District, 18007 Granada, Spain.'}, {'ForeName': 'Patrocinio', 'Initials': 'P', 'LastName': 'Ariza-Vega', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy Division, Faculty of Health Sciences, University of Granada, Avda. De la Ilustración nº60, 18016 Granada, Spain.'}, {'ForeName': 'José-Pascual', 'Initials': 'JP', 'LastName': 'Molina', 'Affiliation': 'LoUISE Research Group, Computing Systems Department, University of Castilla-La Mancha, 02071 Albacete, Spain.'}, {'ForeName': 'Pascual', 'Initials': 'P', 'LastName': 'González', 'Affiliation': 'LoUISE Research Group, Computing Systems Department, University of Castilla-La Mancha, 02071 Albacete, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17124198']
2535,32545539,"Identifying Social Network Conditions that Facilitate Sedentary Behavior Change: The Benefit of Being a ""Bridge"" in a Group-based Intervention.","Using data from one of the first trials to try to leverage social networks as a mechanism for obesity intervention, we examined which social network conditions amplified behavior change. Data were collected as part of a community-based healthy lifestyle intervention in Nashville, USA, between June 2014 and July 2017. Adults randomized to the intervention arm were assigned to a small group of 10 participants that met in person for 12 weekly sessions. Intervention small group social networks were measured three times; sedentary behavior was measured by accelerometry at baseline and 12 months. Multivariate hidden Markov models classified people into distinct social network trajectories over time, based on the structure of the emergent network and where the individual was embedded. A multilevel regression analysis assessed the relationship between network trajectory and sedentary behavior (N = 261). Being a person that connected clusters of intervention participants at any point during the intervention predicted an average reduction of 31.3 min/day of sedentary behavior at 12 months, versus being isolated [95% CI: (-61.4, -1.07),  p  = 0.04]. Certain social network conditions may make it easier to reduce adult sedentary behavior in group-based interventions. While further research will be necessary to establish causality, the implications for intervention design are discussed.",2020,"Being a person that connected clusters of intervention participants at any point during the intervention predicted an average reduction of 31.3 min/day of sedentary behavior at 12 months, versus being isolated [95% CI: (-61.4, -1.07),  p  = 0.04].",[],[],[],[],[],[],,0.0215047,"Being a person that connected clusters of intervention participants at any point during the intervention predicted an average reduction of 31.3 min/day of sedentary behavior at 12 months, versus being isolated [95% CI: (-61.4, -1.07),  p  = 0.04].","[{'ForeName': 'Sabina B', 'Initials': 'SB', 'LastName': 'Gesell', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, NC 27101, USA.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'de la Haye', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, Los Angeles, CA 90007, USA.'}, {'ForeName': 'Evan C', 'Initials': 'EC', 'LastName': 'Sommer', 'Affiliation': 'Department of Pediatrics, Division of Academic General Pediatrics, Vanderbilt University Medical Center, Nashville, TN 37232, USA.'}, {'ForeName': 'Santiago J', 'Initials': 'SJ', 'LastName': 'Saldana', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC 27101, USA.'}, {'ForeName': 'Shari L', 'Initials': 'SL', 'LastName': 'Barkin', 'Affiliation': 'Department of Pediatrics, Division of Academic General Pediatrics, Vanderbilt University Medical Center, Nashville, TN 37232, USA.'}, {'ForeName': 'Edward H', 'Initials': 'EH', 'LastName': 'Ip', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC 27101, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17124197']
2536,32545555,Differential Effects of Dietary Patterns on Advanced Glycation end Products: A Randomized Crossover Study.,"Dietary advanced glycation end products (AGEs) are believed to contribute to pathogenesis of diabetes and cardiovascular disease. The objective of this study was to determine if a diet high in red and processed meat and refined grains (HMD) would elevate plasma concentrations of protein-bound AGEs compared with an energy-matched diet high in whole grain, dairy, nuts and legumes (HWD). We conducted a randomized crossover trial with two 4-week weight-stable dietary interventions in 51 participants without type 2 diabetes (15 men and 36 women aged 35.1 ± 15.6 y; body mass index (BMI), 27.7 ± 6.9 kg/m 2 ). Plasma concentrations of protein-bound Nε-(carboxymethyl) lysine (CML), Nε-(1-carboxyethyl) lysine (CEL) and Nδ-(5-hydro-5-methyl-4-imidazolon-2-yl)-ornithine (MG-H1) were measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS). The HMD significantly increased plasma concentrations (nmol/mL) of CEL (1.367, 0.78 vs. 1.096, 0.65;  p  < 0.01;  n  = 48) compared with the HWD. No differences in CML and MG-H1 between HMD and HWD were observed. HMD increased plasma CEL concentrations compared with HWD in individuals without type 2 diabetes.",2020,"The HMD significantly increased plasma concentrations (nmol/mL) of CEL (1.367, 0.78 vs. 1.096, 0.65;  p  < 0.01;  n  = 48) compared with the HWD.","['Advanced Glycation end Products', '51 participants without type 2 diabetes (15 men and 36 women aged 35.1 ± 15.6 y; body mass index (BMI), 27.7 ± 6.9 kg/m 2 ', 'individuals without type 2 diabetes']","['HMD', 'weight-stable dietary interventions', 'diet high in red and processed meat and refined grains (HMD', 'Nε-(carboxymethyl) lysine (CML), Nε-(1-carboxyethyl) lysine (CEL) and Nδ-(5-hydro-5-methyl-4-imidazolon-2-yl)-ornithine', 'Dietary advanced glycation end products (AGEs']","['plasma CEL concentrations', 'plasma concentrations']","[{'cui': 'C0162574', 'cui_str': 'Advanced Glycation End Products'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517826', 'cui_str': '6.9'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0030072', 'cui_str': 'Oxymetholone'}, {'cui': 'C0424657', 'cui_str': 'Weight steady'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0452956', 'cui_str': 'Processed meat'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C0024337', 'cui_str': 'Lysine'}, {'cui': 'C0029277', 'cui_str': 'Ornithine'}, {'cui': 'C0162574', 'cui_str': 'Advanced Glycation End Products'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0208736', 'cui_str': 'N(6)-(1-carboxyethyl)lysine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",51.0,0.0388324,"The HMD significantly increased plasma concentrations (nmol/mL) of CEL (1.367, 0.78 vs. 1.096, 0.65;  p  < 0.01;  n  = 48) compared with the HWD.","[{'ForeName': 'Yoona', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Department of Food and Nutrition, Institute of Agriculture and Life Science, Gyeongsang National University, Jinju 52828, Korea.'}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'Keogh', 'Affiliation': 'Health and Biomedical Innovation, Clinical and Health Sciences, University of South Australia, Adelaide, SA 5000, Australia.'}, {'ForeName': 'Permal', 'Initials': 'P', 'LastName': 'Deo', 'Affiliation': 'Health and Biomedical Innovation, Clinical and Health Sciences, University of South Australia, Adelaide, SA 5000, Australia.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Clifton', 'Affiliation': 'Health and Biomedical Innovation, Clinical and Health Sciences, University of South Australia, Adelaide, SA 5000, Australia.'}]",Nutrients,['10.3390/nu12061767']
2537,32536538,Palatal needle-free anesthesia for upper molars extraction. A randomized clinical trial.,"BACKGROUND


The aim of this study was to compare the ability of liposomal and non-liposomal lidocaine and prilocaine in hydrogel formulations to promote topical anesthesia in palatal mucosa during upper molar extractions.
METHODS


In this randomized, cross over, triple-blinded clinical trial, a liposomal and a non-liposomal formulation of the eutectic mixture of local anesthetics, 2.5% lidocaine and 2.5% prilocaine, were used to promote palatal anesthesia without the local anesthetic infiltration during bilateral upper molars extractions.
RESULTS


From the total of 40 patients included in this study, the non-liposomal eutectic lidocaine-prilocaine formulation failed in 40% of cases, unlike the liposomal formulation, which was effective for all patients (Fisher's exact test, p < 0.0001). Furthermore, the liposomal formulation (26.75 ± 7,47 min) induced longer anesthesia duration (t-test, p < 0.0001) than the non-liposomal formulation (16.78 ± 4.75 min). No mucosal ulceration or discomfort was reported for both formulations.
CONCLUSION


The liposomal formulation was able to induce adequate anesthesia in palatal mucosa during dental extraction, avoiding the local anesthetic infiltration. For the first time, a topical formulation allowed upper molars surgical removal without injection of any local anesthetic agent into palatal mucosa in adults.",2020,"The liposomal formulation was able to induce adequate anesthesia in palatal mucosa during dental extraction, avoiding the local anesthetic infiltration.","['palatal mucosa during upper molar extractions', 'adults']","['liposomal and a non-liposomal formulation of the eutectic mixture of local anesthetics, 2.5% lidocaine and 2.5% prilocaine', 'Palatal needle-free anesthesia', 'liposomal and non-liposomal lidocaine and prilocaine', 'lidocaine-prilocaine']","['longer anesthesia duration', 'mucosal ulceration or discomfort']","[{'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0059079', 'cui_str': 'Eutectic Mixture of Local Anesthetics'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0033124', 'cui_str': 'Prilocaine'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0617623', 'cui_str': 'Lidocaine- and prilocaine-containing product'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0236053', 'cui_str': 'Mucosal ulcer'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",40.0,0.116154,"The liposomal formulation was able to induce adequate anesthesia in palatal mucosa during dental extraction, avoiding the local anesthetic infiltration.","[{'ForeName': 'Klinger de Souza', 'Initials': 'KS', 'LastName': 'Amorim', 'Affiliation': 'Pharmacology, Anesthesiology and Therapeutics Department of the Piracicaba Dental School, University of Campinas, 901 Limeira Avenue, 13414-903, Piracibaba, São Paulo, Brazil. Electronic address: klinger.amorim@outlook.com.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Franz-Montan', 'Affiliation': 'Pharmacology, Anesthesiology and Therapeutics Department of the Piracicaba Dental School, University of Campinas, 901 Limeira Avenue, 13414-903, Piracibaba, São Paulo, Brazil.'}, {'ForeName': 'Francisco Carlos', 'Initials': 'FC', 'LastName': 'Groppo', 'Affiliation': 'Pharmacology, Anesthesiology and Therapeutics Department of the Piracicaba Dental School, University of Campinas, 901 Limeira Avenue, 13414-903, Piracibaba, São Paulo, Brazil.'}, {'ForeName': 'Bruno Vilela', 'Initials': 'BV', 'LastName': 'Muniz', 'Affiliation': 'Pharmacology, Anesthesiology and Therapeutics Department of the Piracicaba Dental School, University of Campinas, 901 Limeira Avenue, 13414-903, Piracibaba, São Paulo, Brazil.'}, {'ForeName': 'Jaiza Samara Macena de', 'Initials': 'JSM', 'LastName': 'Araújo', 'Affiliation': 'Pharmacology, Anesthesiology and Therapeutics Department of the Piracicaba Dental School, University of Campinas, 901 Limeira Avenue, 13414-903, Piracibaba, São Paulo, Brazil.'}, {'ForeName': 'José Vânison Ferreira', 'Initials': 'JVF', 'LastName': 'Santana', 'Affiliation': 'Federal University of Sergipe, Oral Surgery and Anesthesiology Area of Dentistry Department, St Cláudio Batista, 49060-108, Aracaju, Cidade Nova, Sergipe, Brazil.'}, {'ForeName': 'Anne Caroline Gercina Carvalho', 'Initials': 'ACGC', 'LastName': 'Dantas', 'Affiliation': 'Federal University of Sergipe, Oral Surgery and Anesthesiology Area of Dentistry Department, St Cláudio Batista, 49060-108, Aracaju, Cidade Nova, Sergipe, Brazil.'}, {'ForeName': 'Eneida', 'Initials': 'E', 'LastName': 'de Paula', 'Affiliation': 'Biochemistry and Tissue Biology Department, Biology Institute, University of Campinas, St Monteiro Lobato 255, 13083-862, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Liane Maciel de Almeida', 'Initials': 'LMA', 'LastName': 'Souza', 'Affiliation': 'Federal University of Sergipe, Oral Surgery and Anesthesiology Area of Dentistry Department, St Cláudio Batista, 49060-108, Aracaju, Cidade Nova, Sergipe, Brazil.'}]",Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery,['10.1016/j.jcms.2020.05.001']
2538,32536582,Impact of short-term overfeeding of saturated or unsaturated fat or sugars on the gut microbiota in relation to liver fat in obese and overweight adults.,"BACKGROUNDS & AIMS


Intestinal microbiota may be causally involved in the pathogenesis of non-alcoholic fatty liver disease (NAFLD). We aimed to study the effect of short-term overfeeding on human gut microbiota in relation to baseline and overfeeding-induced liver steatosis. We also asked whether the baseline microbiota composition is associated to the overfeeding-induced increase in liver fat.
METHODS


In a randomized trial, 38 overweight and obese subjects were assigned to consume an excess of 1000 kcal/day of diets rich in either saturated fat, unsaturated fat, or simple sugars for 3 weeks. Fasting blood samples and  1 H-MR spectroscopy were used for extensive clinical phenotyping as previously reported (PMID: 29844096). Fecal samples were collected for the analysis of the gut microbiota using 16S rRNA amplicon sequencing, imputed metagenomics and qPCR. Microbiota results were correlated with dietary intakes and clinical measurements before and during overfeeding.
RESULTS


The overall community structure of the microbiota remained highly stable and personalized during overfeeding based on between-sample Bray-Curtis dissimilarity, but the relative abundances of individual taxa were altered in a diet-specific manner: overfeeding saturated fat increased Proteobacteria, while unsaturated fat increased butyrate producers. Sugar overfeeding increased Lactococcus and Escherichia coli. Imputed functions of the gut microbiota were not affected by overfeeding. Several taxa affected by overfeeding significantly correlated with the changes in host metabolic markers. The baseline levels of proteobacterial family Desulfovibrionaceae, and especially genus Bilophila, were significantly associated to overfeeding-induced liver fat increase independently of the diet arm. In general, limited overlap was observed between the overfeeding-induced microbiota changes and the liver fat-associated microbiota features at baseline.
CONCLUSIONS


Our work indicates that the human gut microbiota is resilient to short-term overfeeding on community level, but specific taxa are altered on diet composition-dependent manner. Generalizable microbiota signatures directly associated with liver steatosis could not be identified. Instead, the carriage of Bilophila was identified as a potential novel risk factor for diet-induced liver steatosis in humans. Clinical trial registry number: NCT02133144 listed on NIH website: ClinicalTrials.gov.",2020,"The baseline levels of proteobacterial family Desulfovibrionaceae, and especially genus Bilophila, were significantly associated to overfeeding-induced liver fat increase independently of the diet arm.","['38 overweight and obese subjects', 'obese and overweight adults']","['saturated or unsaturated fat or sugars', 'short-term overfeeding', 'consume an excess of 1000\xa0kcal/day of diets rich in either saturated fat, unsaturated fat, or simple sugars for 3 weeks']","['Lactococcus and Escherichia coli', 'liver steatosis']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0015678', 'cui_str': 'Unsaturated fat'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0456649', 'cui_str': 'kcal/day'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0026492', 'cui_str': 'Monosaccharide'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0085549', 'cui_str': 'Lactococcus'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}]",38.0,0.0365252,"The baseline levels of proteobacterial family Desulfovibrionaceae, and especially genus Bilophila, were significantly associated to overfeeding-induced liver fat increase independently of the diet arm.","[{'ForeName': 'Ching', 'Initials': 'C', 'LastName': 'Jian', 'Affiliation': 'Human Microbiome Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Panu', 'Initials': 'P', 'LastName': 'Luukkonen', 'Affiliation': 'Minerva Foundation Institute for Medical Research, Helsinki, Finland; Department of Medicine, University of Helsinki and Helsinki University Central Hospital, Helsinki, Finland.'}, {'ForeName': 'Sanja', 'Initials': 'S', 'LastName': 'Sädevirta', 'Affiliation': 'Minerva Foundation Institute for Medical Research, Helsinki, Finland; Department of Medicine, University of Helsinki and Helsinki University Central Hospital, Helsinki, Finland.'}, {'ForeName': 'Hannele', 'Initials': 'H', 'LastName': 'Yki-Järvinen', 'Affiliation': 'Minerva Foundation Institute for Medical Research, Helsinki, Finland; Department of Medicine, University of Helsinki and Helsinki University Central Hospital, Helsinki, Finland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Salonen', 'Affiliation': 'Human Microbiome Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland. Electronic address: anne.salonen@helsinki.fi.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.05.008']
2539,32536587,Effect of Pretreatment and Activation Mode on the Interfacial Adaptation of Nanoceramic Resin Inlay and Self-adhesive Resin Cement.,"OBJECTIVES


The first objective of this study was to determine if the luting material used for resin nanoceramic inlay affects interfacial adaptation. The second was to investigate whether pretreatment and the adhesive curing method before cementation affects interfacial adaptation. The final objective was to compare activation modes of luting material.
METHODS


Class I cavities were prepared on extracted human third molars. Resin nanoceramic inlays were fabricated using Lava Ultimate CAD/CAM block (3 M). For the control groups, inlays were cemented using Panavia V5 (Kuraray Noritake). For the experimental groups, teeth were randomly divided into five experimental groups with four subgroups using different self-adhesive cements (SACs). Cement in Group I was dual-cured without pretreatment. In Group II, the cement was dual-cured after polyacrylic acid treatment of the tooth cavity. In Groups III and IV, the cement was dual-cured after universal dentin adhesive treatment with pre-cure and co-cure methods. In Group V, the inlay was cemented in self-cure mode. After thermocycling, interfacial adaptation at the inlay-tooth interface was measured using swept-source optical coherence tomography (SS-OCT) imaging. Finally, polymerization shrinkage strain of the luting material was measured and compared.
RESULTS


Interfacial adaptation differed depending on the luting material. After application of a universal adhesive, some subgroups showed improved interfacial adaptation. Interfacial adaptation and polymerization shrinkage strain differed significantly depending on activation mode.
SIGNIFICANCE


Interfacial adaptation for a resin nanoceramic inlay can differ according to the type of SAC and activation mode. For some SACs, application of a universal adhesive before cementation improves interfacial adaptation.",2020,"Interfacial adaptation and polymerization shrinkage strain differed significantly depending on activation mode.
","['Class', 'Nanoceramic Resin Inlay and Self-adhesive Resin Cement']",['self-adhesive cements (SACs'],"['interfacial adaptation', 'Interfacial adaptation and polymerization shrinkage strain']","[{'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0021513', 'cui_str': 'Dental Inlays'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0376523', 'cui_str': 'Resin Cement'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0382302', 'cui_str': 'Adhesive cement'}]","[{'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0314672', 'cui_str': 'Polymerization'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}]",,0.0172676,"Interfacial adaptation and polymerization shrinkage strain differed significantly depending on activation mode.
","[{'ForeName': 'Seung-Hoon', 'Initials': 'SH', 'LastName': 'Han', 'Affiliation': 'Department of Conservative Dentistry, St. Vincent Hospital, College of Medicine, The Catholic University of Korea, 93 Jungbu-daero, Paldal-gu, Suwon, Gyeonggi-do, South Korea. Electronic address: han7537@hotmail.com.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Shimada', 'Affiliation': 'Department of Operative Dentistry, Okayama University, 2-5-1 Shikata-cho, Kita-ku, Okayama 700-8525, Japan; Department of Cariology and Operative Dentistry, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-0034 Japan. Electronic address: shimada.ope@okayama-u.ac.jp.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Sadr', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, University of Washington, 1959 NE Pacific St, B162, Seattle, WA, 98195 USA. Electronic address: arsadr@uw.edu.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Tagami', 'Affiliation': 'Department of Cariology and Operative Dentistry, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-0034 Japan. Electronic address: tagami.ope@tmd.ac.jp.'}, {'ForeName': 'Kee-Yeon', 'Initials': 'KY', 'LastName': 'Kum', 'Affiliation': 'Department of Conservative Dentistry, Dental Research Institute, National Dental Care Center for Persons with Special Needs, Seoul National University Dental Hospital, Seoul National University School of Dentistry, 101 Daehak-ro, Jongno-gu, Seoul, 08030, Republic of Korea. Electronic address: kum6139@snu.ac.kr.'}, {'ForeName': 'Sung-Ho', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Department of Conservative Dentistry, Oral Science Research Center, College of Dentistry, Yonsei University, #50 Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea. Electronic address: sunghopark@yuhs.ac.'}]",Dental materials : official publication of the Academy of Dental Materials,['10.1016/j.dental.2020.05.005']
2540,32536594,"Reply to Eugenio Ventimiglia, Steeve Doizi, Andrea Salonia, and Olivier Traxer's Letter to the Editor re: Farha Pirani, Salima S. Makhani, Frances Y. Kim, et al. Prospective Randomized Trial Comparing the Safety and Clarity of Water Versus Saline Irrigant in Ureteroscopy. Eur Urol Focus. In press. https://doi.org/10.1016/j.euf.2020.02.009.",,2020,,[],['Water Versus Saline Irrigant'],[],[],"[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0593225', 'cui_str': 'Solution for irrigation'}]",[],,0.0235947,,"[{'ForeName': 'Farha', 'Initials': 'F', 'LastName': 'Pirani', 'Affiliation': 'Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Salima', 'Initials': 'S', 'LastName': 'Makhani', 'Affiliation': 'School of Medicine, Mercer University, Macon, GA, USA.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Lay', 'Affiliation': 'Department of Urology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Cimmino', 'Affiliation': 'Department of Urology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Hartsell', 'Affiliation': 'Department of Urology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Spence', 'Affiliation': 'Department of Urology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Viraj A', 'Initials': 'VA', 'LastName': 'Master', 'Affiliation': 'Department of Urology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Ogan', 'Affiliation': 'Department of Urology, Emory University School of Medicine, Atlanta, GA, USA. Electronic address: kogan@emory.edu.'}]",European urology focus,['10.1016/j.euf.2020.05.006']
2541,32536680,Erratum for A Comparison of the Weight Loss Effect between a Low-carbohydrate Diet and a Calorie-restricted Diet in Combination with Intragastric Balloon Therapy.,,2020,,[],['Low-carbohydrate Diet and a Calorie-restricted Diet in Combination with Intragastric Balloon Therapy'],[],[],"[{'cui': 'C0259836', 'cui_str': 'Carbohydrate restricted diet'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.0105694,,"[{'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Maekawa', 'Affiliation': 'Nagano Matsushiro General Hospital, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Niizawa', 'Affiliation': 'Nagano Matsushiro General Hospital, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Harada', 'Affiliation': 'Third Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan.'}]","Internal medicine (Tokyo, Japan)",['10.2169/internalmedicine.E002-20']
2542,32536827,New perspectives in allergen specific immunotherapy driven by big trials with house dust mite sublingual SQ ®  tablets.,"House-dust mites (HDM) allergy is the prevailing condition in subjects allergic to inhalants. Clinical studies with HDM extracts-either subcutaneous (SCIT) or sublingual (SLIT) have long been characterized by small sample size, varying allergen doses, and poorly defined endpoints assessing disease severity. In the last decade, well-designed, randomized, controlled studies recruiting thousands of patients have been conducted with newly developed HDM sublingual tablets (SQ ® -HDM tablets). This drug is easily dispersible in the oral cavity due to the patented Zydis ®  technology and its allergen composition is balanced in terms of group I and group II major mite allergen content, reflecting the equal contribution of the two components to HDM sensitization. HDM is the most common allergen associated with asthma. Clinical efficacy of the SQ ®  HDM SLIT-tablet in HDM allergic asthma has been evaluated in randomized, double-blind, placebo-controlled trials. Both endpoints related to ""present"" asthma control (inhaled corticosteroid-ICS) as well as endpoints related to ""future"" asthma control (occurrence of asthma exacerbations) were included in these studies, in agreement with GINA (Global Initiative for Asthma) guidelines. Based on the positive results of these studies, SQ ® -HDM SLIT-tablets were approved Europe-wide as registered drug for treating moderate-to-severe allergic rhinitis with or without allergic asthma and not well controlled HDM allergic asthma, associated with allergic rhinitis of any severity. GINA guidelines in 2017 included SLIT-tablet-based immunotherapy as an ""add-on"" treatment for asthmatic patients sensitized to HDM; indeed, allergen immunotherapy (AIT) is considered to be a complementary treatment option that targets the immunological of allergic diseases, representing the only treatment potentially disease-modifier or, at least, with a long-term efficacy. The availability of a safe, standardized, registered treatment for HDM respiratory allergies is pivotal in the immunotherapy field, pushing it out of a century-long limbo of amatorial interest towards the full dignity deserved by the only casual treatment of respiratory allergies.",2020,House-dust mites,"['House-dust mites', 'HDM allergic asthma']","['HDM extracts-either subcutaneous (SCIT) or sublingual (SLIT', 'SQ ®  HDM SLIT-tablet', 'placebo']","['future"" asthma control (occurrence of asthma exacerbations']","[{'cui': 'C0998367', 'cui_str': 'House dust mite'}, {'cui': 'C0524581', 'cui_str': 'House dust'}, {'cui': 'C0155877', 'cui_str': 'Allergic asthma'}]","[{'cui': 'C0524581', 'cui_str': 'House dust'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C0184904', 'cui_str': 'Slitting'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}]",,0.102552,House-dust mites,"[{'ForeName': 'Gianfranco', 'Initials': 'G', 'LastName': 'Vitiello', 'Affiliation': 'Experimental and Clinical Medicine Department, University of Firenze, Largo Brambilla 3, 50100 Florence, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Maltagliati', 'Affiliation': 'Experimental and Clinical Medicine Department, University of Firenze, Largo Brambilla 3, 50100 Florence, Italy.'}, {'ForeName': 'Oliviero', 'Initials': 'O', 'LastName': 'Rossi', 'Affiliation': 'SOD Immunoallergologia, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.'}]",Clinical and molecular allergy : CMA,['10.1186/s12948-020-00124-7']
2543,32536828,"Effects of concomitant use of prasugrel with edoxaban on bleeding time, pharmacodynamics, and pharmacokinetics of edoxaban in healthy elderly Japanese male subjects: a clinical pharmacology study.","Background


Dual therapy with a direct oral anticoagulant (DOAC) plus a P2Y 12  receptor inhibitor is recommended in patients with nonvalvular atrial fibrillation who undergo percutaneous coronary intervention. Thus, we evaluated the effects of DOAC edoxaban plus P2Y 12  receptor inhibitor prasugrel on bleeding time (BT), and pharmacodynamics (PD) and pharmacokinetics (PK) of edoxaban in healthy elderly Japanese male subjects.
Methods


A single-center, clinical pharmacology study with randomized, open-label, repeated dosing enrolled 24 participants in two groups of 12 receiving 30 mg edoxaban once daily for 3 days; then 30 mg edoxaban plus 2.5 mg prasugrel (Group 1) or 30 mg edoxaban plus 3.75 mg prasugrel (Group 2) once daily for 5 days. Primary endpoint was BT by the Ivy method. Secondary endpoints were the PD parameters of prothrombin time (PT), activated partial thromboplastin time (aPTT), prothrombin fragment F1 + 2 (F1 + 2), and P2Y 12  reaction units (PRU), and PK profiles of edoxaban alone and in combination with prasugrel.
Results


Geometric least squares mean of BT ratios (vs. baseline) for 3-day edoxaban treatment were 1.097 (90% confidence interval (CI) 0.911-1.321) in Group 1 and 1.327 (90% CI 1.035-1.703) in Group 2; for 5-day edoxaban plus 2.5 mg and 3.75 mg prasugrel, they were 1.581 (90% CI 1.197-2.087) and 1.996 (90% CI 1.482-2.690), respectively. Contributions of prasugrel to the effects (edoxaban + prasugrel/edoxaban) were 1.442 (90% CI 1.096-1.897) in Group 1 and 1.504 (90% CI 1.172-1.930) in Group 2. Edoxaban prolonged PT and aPTT and decreased F1 + 2. Adding on prasugrel did not appreciably change PT, aPTT, or F1 + 2. Prasugrel reduced PRU, whereas edoxaban had no effect on PRU. We recorded 26 adverse events; 23 were treatment-emergent (positive fecal occult blood test). All participants with adverse events recovered during follow-up.
Conclusions


Coadministration of 2.5 mg and 3.75 mg prasugrel with 30 mg edoxaban prolonged BT in healthy elderly Japanese male subjects. The effect was dependent on the dose of prasugrel. Prasugrel did not affect PD or PK profiles of edoxaban. Edoxaban had no effect on PD of prasugrel.
Trial registration


Japan Registry of Clinical Trials No. jRCTs071190006; registration date, 26-April-2019.",2020,Edoxaban prolonged PT and aPTT and decreased F1 + 2.,"['24 participants in two groups of 12 receiving 30\u2009mg', 'patients with nonvalvular atrial fibrillation who undergo percutaneous coronary intervention', 'healthy elderly Japanese male subjects']","['edoxaban plus 2.5\u2009mg prasugrel', 'direct oral anticoagulant (DOAC) plus a P2Y 12  receptor inhibitor', 'edoxaban', 'Prasugrel', 'prasugrel', 'Edoxaban', 'prasugrel with edoxaban', 'edoxaban plus 3.75\u2009mg prasugrel', 'edoxaban + prasugrel/edoxaban', 'edoxaban prolonged BT', 'DOAC edoxaban']","['bleeding time, pharmacodynamics, and pharmacokinetics', 'PD of prasugrel', 'PD parameters of prothrombin time (PT), activated partial thromboplastin time (aPTT), prothrombin fragment F1\u2009+\u20092 (F1\u2009+\u20092), and P2Y 12  reaction units (PRU), and PK profiles of edoxaban alone and in combination with prasugrel', 'Geometric least squares mean of BT ratios', 'adverse events', 'bleeding time (BT), and pharmacodynamics (PD) and pharmacokinetics (PK', 'PRU']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C4517697', 'cui_str': '3.75'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}]","[{'cui': 'C0005729', 'cui_str': 'Bleeding time'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}, {'cui': 'C0033706', 'cui_str': 'Prothrombin'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}, {'cui': 'C0072436', 'cui_str': 'Prothrombin fragment 1.2'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",24.0,0.0484519,Edoxaban prolonged PT and aPTT and decreased F1 + 2.,"[{'ForeName': 'Ippei', 'Initials': 'I', 'LastName': 'Ikushima', 'Affiliation': 'Sumida Hospital, 29-1, Honjo 1-Chome, Sumida-ku, Tokyo, 130-0004 Japan.'}, {'ForeName': 'Takaaki', 'Initials': 'T', 'LastName': 'Akasaka', 'Affiliation': 'Medical Science Department, Daiichi Sankyo Co., Ltd., 3-5-1 Nihonbashi Honcho, Chuo-ku, Tokyo, 103-8426 Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Morishima', 'Affiliation': 'Medical Science Department, Daiichi Sankyo Co., Ltd., 3-5-1 Nihonbashi Honcho, Chuo-ku, Tokyo, 103-8426 Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Takita', 'Affiliation': 'Biostatistics & Data Management Department, Daiichi Sankyo Co., Ltd., 1-2-58 Hiromachi, Shinagawa-ku, Tokyo, 140-8710 Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Motohashi', 'Affiliation': 'Medical Science Department, Daiichi Sankyo Co., Ltd., 3-5-1 Nihonbashi Honcho, Chuo-ku, Tokyo, 103-8426 Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Medical Science Department, Daiichi Sankyo Co., Ltd., 3-5-1 Nihonbashi Honcho, Chuo-ku, Tokyo, 103-8426 Japan.'}]",Thrombosis journal,['10.1186/s12959-020-00223-0']
2544,32536844,Access times for supraclavicular and infraclavicular approaches of subclavian vein catheterization in pacemaker insertion.,"Objective


Infraclavicular (IC) approach of subclavian vein (SCV) catheterization is widely used as compared to supraclavicular (SC) approach for pacemaker insertion. The aim of the study was to compare the ease of catheterization of SCV using SC versus IC approach and also record the incidence of complications related to the approach.
Methods


In the prospective and interventional study, 102 patients enrolled were randomly divided into two groups. In one group, the right SCV catheterization was performed using SC approach, and in the other group, catheterization was performed using IC approach. The total number of participants, who fulfilled the requirements, was 92. Access time, success rate of cannulation, number of attempts to cannulate vein, ease of guidewire and catheter insertion, placement of temporary wire as cine time, patient comfort, and associated complications were recorded. The data collected were analyzed on SPSS software version 26.
Results


The SC approach had a lesser access time as compared to IC approach and this was found to be significant. Non-significant parameters included complications, number of attempts, and cine time. Only one patient from the IC group developed pneumothorax.
Conclusions


The SC approach of SCV catheterization is comparable to IC approach in terms of landmark accessibility, success rate, and rate of complications. However, IC approach is less feasible in terms of time constraint and is, therefore, less likely to be successful.",2020,"The SC approach had a lesser access time as compared to IC approach and this was found to be significant. Non-significant parameters included complications, number of attempts, and cine time.","['102 patients enrolled', 'pacemaker insertion']","['Objective\n\n\nInfraclavicular (IC) approach of subclavian vein (SCV) catheterization', 'subclavian vein catheterization', 'right SCV catheterization']","['complications, number of attempts, and cine time', 'pneumothorax', 'landmark accessibility, success rate, and rate of complications', 'Access time, success rate of cannulation, number of attempts to cannulate vein, ease of guidewire and catheter insertion, placement of temporary wire as cine time, patient comfort, and associated complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0189817', 'cui_str': 'Insertion of intracardiac pacemaker'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1563183', 'cui_str': 'Infraclavicular approach'}, {'cui': 'C0038532', 'cui_str': 'Structure of subclavian vein'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C1319106', 'cui_str': 'Catheterization of subclavian vein'}, {'cui': 'C0489887', 'cui_str': 'Structure of right subclavian vein'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0181089', 'cui_str': 'Guide wire'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0005978', 'cui_str': 'Bone wire'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]",102.0,0.0412492,"The SC approach had a lesser access time as compared to IC approach and this was found to be significant. Non-significant parameters included complications, number of attempts, and cine time.","[{'ForeName': 'Nismat', 'Initials': 'N', 'LastName': 'Javed', 'Affiliation': 'Department of Clinical Health Sciences, Shifa College of Medicine, Shifa Tameer-e-Millat University, Islamabad, 44000, Pakistan.'}, {'ForeName': 'Jahanzeb', 'Initials': 'J', 'LastName': 'Malik', 'Affiliation': 'Department of Cardiology, Registrar Cardiology, Rawalpindi Institute of Cardiology, Rawalpindi, 46000, Pakistan.'}]",International journal of health sciences,[]
2545,32536984,"Disease activity guided stepwise tapering or discontinuation of rhTNFR:Fc, an etanercept biosimilar, in patients with ankylosing spondylitis: a prospective, randomized, open-label, multicentric study.","Background


The aim of this study was to evaluate disease-activity-guided stepwise tapering or discontinuation of rhTNFR:Fc, an etanercept biosimilar, in patients with ankylosing spondylitis (AS) in a prospective, randomized, open-label, multicentric study.
Methods


Active AS patients with AS disease activity score (ASDAS) ⩾2.1 recruited from 10 hospitals were treated with rhTNFR:Fc 50 mg weekly for 12 weeks, and further randomized into different tapering or discontinuation groups according to ASDAS at week 12. Patients who achieved clinical remission (ASDAS < 1.3) were assigned randomly to stepwise tapering group or discontinuation group. Patients who achieved low disease activity (LDA, 1.3⩽ASDAS < 2.1) were assigned randomly to stepwise tapering, delayed tapering, or discontinuation group. All patients were evaluated every 12 weeks until week 48. The primary endpoint was cumulative flare rates in different groups at week 48.
Results


A total of 311 patients were enrolled with an average ASDAS of 3.6 ± 1.0, and 259 completed 12 weeks of rhTNFR:Fc induction therapy, with 148 patients (57.1%) achieved clinical remission, 100 (38.6%) achieved LDA, and 11 (4.3%) remained as high disease activity (ASDAS⩾2.1). In patients who achieved clinical remission at week 12, stepwise tapering of rhTNFR:Fc demonstrated significantly lower flare rates at each evaluation compared with discontinuation. In patients who achieved LDA, there was no significant difference of flare rates between stepwise tapering, delayed tapering, and discontinuation. With stepwise tapering of rhTNFR:Fc, flare rates were comparable in AS patients, irrespective of initial ASDAS before tapering.
Conclusion


Stepwise tapering of rhTNFR:Fc when patients achieved clinical remission was able to maintain favorable low flare rates in 48 weeks. LDA was an alternative therapeutic target, as well as an viable timing for initiation of rhTNFR:Fc tapering. rhTNFR:Fc 25 mg monthly maintained flare-free status in a considerable number of patients. However, abrupt discontinuation of rhTNFR:Fc even if patients achieved clinical remission should be avoided.
Trial registration


ClinicalTrials.gov: NCT03880968,URL: https://clinicaltrials.gov/ct2/show/NCT03880968.",2020,"In patients who achieved LDA, there was no significant difference of flare rates between stepwise tapering, delayed tapering, and discontinuation.","['Methods\n\n\nActive AS patients with AS disease activity score (ASDAS) ⩾2.1 recruited from 10 hospitals were treated with', 'patients with ankylosing spondylitis', 'Patients who achieved low disease activity (LDA, 1.3⩽ASDAS\u2009<\u20092.1', 'patients with ankylosing spondylitis (AS', '311 patients were enrolled with an average ASDAS of 3.6\u2009±\u20091.0, and 259 completed 12\u2009weeks of', 'Patients who achieved clinical remission (ASDAS\u2009<\u20091.3']","['NCT03880968,URL', 'LDA', 'rhTNFR']","['flare rates', 'clinical remission', 'cumulative flare rates']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0226032', 'cui_str': 'Structure of anterior descending branch of left coronary artery'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C4517499', 'cui_str': '1.3'}]","[{'cui': 'C0226032', 'cui_str': 'Structure of anterior descending branch of left coronary artery'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",311.0,0.0232254,"In patients who achieved LDA, there was no significant difference of flare rates between stepwise tapering, delayed tapering, and discontinuation.","[{'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Division of Rheumatology, the Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Jianing', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Division of Rheumatology, the Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Dongyi', 'Initials': 'D', 'LastName': 'He', 'Affiliation': 'Division of Rheumatology, Shanghai Guanghua Integrative Medicine Hospital Affiliated to Shanghai University of Tradition Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Division of Rheumatology, the First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Hongzhi', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Division of Rheumatology, the First Hospital of Jiaxing, Jiaxing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Division of Rheumatology, Shaoxing Second Hospital, Shaoxing, Zhejiang, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Xue', 'Affiliation': ""Division of Rheumatology, Shanghai Jiaotong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Weili', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Division of Rheumatology, Ningbo Medical Center Lihuili Hospital, Ningbo, China.'}, {'ForeName': 'Guangbo', 'Initials': 'G', 'LastName': 'Xiang', 'Affiliation': 'Division of Rheumatology, Wenzhou Central Hospital, Wenzhou, China.'}, {'ForeName': 'Yasong', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Division of Rheumatology, Zhejiang Provincial People's Hospital, Hangzhou, China.""}, {'ForeName': 'Zhongming', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': ""Division of Rheumatology, Shaoxing People's Hospital, Shaoxing, China.""}, {'ForeName': 'Huaxiang', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Division of Rheumatology, the Second Affiliated Hospital of Zhejiang University School of Medicine, No.88, Jiefang Road, Hangzhou 310009, China.'}]",Therapeutic advances in musculoskeletal disease,['10.1177/1759720X20929441']
2546,32537010,"Combination of sufentanil, dexmedetomidine and ropivacaine to improve epidural labor analgesia effect: A randomized controlled trial.","Opioids and α2-agonists have been used as epidural adjuvants in local anesthetics for a long time, but the effect of the combination of opioids and α2-agonists as epidural adjuvants is not completely understood. In the present study, the combination of dexmedetomidine (Dex) and sufentanil as adjuvants to ropivacaine for epidural labor analgesia was investigated. A total of 108 parturient women receiving labor epidural analgesia were randomly divided into three groups: i) Group RD received 0.1% ropivacaine + 0.5 µg/ml Dex; ii) Group RS received 0.1% ropivacaine + 0.5 µg/ml sufentanil; and iv) Group RDS received 0.1% ropivacaine + 0.25 µg/ml Dex + 0.25 µg/ml sufentanil. Patients received a 10 ml loading dose followed by a maintenance by patient controlled epidural analgesia. The visual analog scale scores, onset time, local anesthetic requirements, motor blockage and adverse effects were recorded. Group RDS displayed an improved labor analgesia effect compared with Groups RD and RS. Group RDS displayed a shorter onset time compared with Groups RD and RS, and a reduced local anesthetic requirement compared with Group RS. The motor blockage in Groups RDS and RS was significantly lower compared with Group RD, and the incidence of pruritus in Groups RDS and RD was lower compared with Group RS. In conclusion, the combined use of 0.25 µg/ml Dex and 0.25 µg/ml sufentanil as adjuvants to 0.1% ropivacaine for epidural labor analgesia displayed an improved analgesia effect compared with the use of either 0.5 µg/ml sufentanil or 0.5 µg/ml Dex alone. The present study was registered with the Chinese Clinical Trial Registry Center on 23 February, 2018 (registration no. ChiCTR-IOR-1800014943).",2020,"The motor blockage in Groups RDS and RS was significantly lower compared with Group RD, and the incidence of pruritus in Groups RDS and RD was lower compared with Group RS.","['Chinese Clinical Trial Registry Center on 23 February, 2018 (registration no', '108 parturient women receiving labor epidural analgesia']","['Dex and 0.25 µg/ml sufentanil', 'sufentanil', 'ropivacaine', 'Dex alone', 'ropivacaine + 0.5 µg/ml Dex; ii) Group RS received 0.1% ropivacaine + 0.5 µg/ml sufentanil; and iv', 'ropivacaine + 0.25 µg/ml Dex + 0.25 µg/ml sufentanil', 'sufentanil, dexmedetomidine and ropivacaine', 'dexmedetomidine (Dex) and sufentanil']","['epidural labor analgesia effect', 'visual analog scale scores, onset time, local anesthetic requirements, motor blockage and adverse effects', 'shorter onset time', 'labor analgesia effect', 'local anesthetic requirement', 'analgesia effect']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}]","[{'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C1301740', 'cui_str': 'Analgesia in labor'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",108.0,0.070917,"The motor blockage in Groups RDS and RS was significantly lower compared with Group RD, and the incidence of pruritus in Groups RDS and RD was lower compared with Group RS.","[{'ForeName': 'Gehui', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Shenzhen Maternity and Child Healthcare Hospital, Southern Medical University, Shenzhen, Guangdong 518028, P.R. China.'}, {'ForeName': 'Yuci', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': 'Department of Anesthesiology, Shenzhen Maternity and Child Healthcare Hospital, Southern Medical University, Shenzhen, Guangdong 518028, P.R. China.'}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Qi', 'Affiliation': 'Department of Anesthesiology, Shenzhen Maternity and Child Healthcare Hospital, Southern Medical University, Shenzhen, Guangdong 518028, P.R. China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Food Safety, Market Supervision Administration of Shenzhen Municipality, Shenzhen, Guangdong 518040, P.R. China.'}, {'ForeName': 'Xiaoguang', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Shenzhen Maternity and Child Healthcare Hospital, Southern Medical University, Shenzhen, Guangdong 518028, P.R. China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, Shenzhen Maternity and Child Healthcare Hospital, Southern Medical University, Shenzhen, Guangdong 518028, P.R. China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Shenzhen Maternity and Child Healthcare Hospital, Southern Medical University, Shenzhen, Guangdong 518028, P.R. China.'}, {'ForeName': 'Yuantao', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Shenzhen Maternity and Child Healthcare Hospital, Southern Medical University, Shenzhen, Guangdong 518028, P.R. China.'}]",Experimental and therapeutic medicine,['10.3892/etm.2020.8730']
2547,32537072,"Efficacy of artemether-lumefantrine and artesunate-amodiaquine as first line therapy of uncomplicated malaria in Burkina Faso, 11 years after policy change.","Introduction


Artemether-lumefantrine (AL) and artesunate-amodiaquine (ASAQ) are the first line therapy of uncomplicated malaria in Burkina Faso. We assessed the treatment efficacy, tolerability of these drugs 11 years following its adoption as first line treatment.
Methods


In this opened randomized controlled trial carried out in 2016, participants with age over 6 months who consented to participate were randomly assigned treatment with artemether-lumefantrine or artesunate-amodiaquine and followed up for 28 days. Primary endpoint was the treatment efficacy over 28 days of follow up unadjusted by Polymerase chain reaction (PCR).
Results


Two hundred and eighty-one (281) participants were enrolled and the completion rate was 92.9%. No early treatment failure was found. Adequate clinical and parasitological responses were significantly higher in artesunate-amodiaquine group (97% versus 85.2%, p = 0.0008). On day 28, the risk of failure was 4 times higher in AL group 20.14%, 95% CI (13-30.47) against 5.16%, 95% CI (1.91-13.54) in ASAQ group. All treatments had a similar and good tolerability profile.
Conclusion


Eleven years following artemether-lumefantrine and artesunate-amodiaquine adoption as first line therapy for uncomplicated malaria in Burkina Faso, artemether-lumefantrine retained fairly good efficacy even though its efficacy fell below WHO threshold of 90% considering uncorrected outcome.",2020,"On day 28, the risk of failure was 4 times higher in AL group 20.14%, 95% CI (13-30.47) against 5.16%, 95% CI (1.91-13.54) in ASAQ group.","['uncomplicated malaria in Burkina Faso, 11 years after policy change', 'uncomplicated malaria in Burkina Faso', 'Two hundred and eighty-one (281) participants were enrolled and the', '2016, participants with age over 6 months who consented to participate']","['artemether-lumefantrine and artesunate-amodiaquine', 'lumefantrine and artesunate-amodiaquine', 'Introduction\n\n\nArtemether-lumefantrine (AL) and artesunate-amodiaquine (ASAQ', 'artemether-lumefantrine or artesunate-amodiaquine', 'artesunate-amodiaquine']","['treatment efficacy', 'completion rate', 'Polymerase chain reaction (PCR', 'Adequate clinical and parasitological responses', 'tolerability profile', 'risk of failure', 'treatment efficacy, tolerability']","[{'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0006409', 'cui_str': 'Burkina Faso'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0936150', 'cui_str': 'artemether and lumefantrine'}, {'cui': 'C0052432', 'cui_str': 'artesunate'}, {'cui': 'C0002641', 'cui_str': 'Amodiaquine'}, {'cui': 'C0531104', 'cui_str': 'lumefantrine'}]","[{'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205468', 'cui_str': 'Parasitologic'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",2016.0,0.0680897,"On day 28, the risk of failure was 4 times higher in AL group 20.14%, 95% CI (13-30.47) against 5.16%, 95% CI (1.91-13.54) in ASAQ group.","[{'ForeName': 'Issaka', 'Initials': 'I', 'LastName': 'Zongo', 'Affiliation': ""Institut de Recherche en Sciences de la Santé, Direction Régionale de l'Ouest, Bobo-Dioulasso, Burkina Faso.""}, {'ForeName': 'Yves Daniel', 'Initials': 'YD', 'LastName': 'Compaoré', 'Affiliation': ""Institut de Recherche en Sciences de la Santé, Direction Régionale de l'Ouest, Bobo-Dioulasso, Burkina Faso.""}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Nikiéma', 'Affiliation': ""Institut de Recherche en Sciences de la Santé, Direction Régionale de l'Ouest, Bobo-Dioulasso, Burkina Faso.""}, {'ForeName': 'Moussa', 'Initials': 'M', 'LastName': 'Zongo', 'Affiliation': ""Institut de Recherche en Sciences de la Santé, Direction Régionale de l'Ouest, Bobo-Dioulasso, Burkina Faso.""}, {'ForeName': 'Nouhoun', 'Initials': 'N', 'LastName': 'Barry', 'Affiliation': ""Institut de Recherche en Sciences de la Santé, Direction Régionale de l'Ouest, Bobo-Dioulasso, Burkina Faso.""}, {'ForeName': 'Fabrice Anyirékun', 'Initials': 'FA', 'LastName': 'Somé', 'Affiliation': ""Institut de Recherche en Sciences de la Santé, Direction Régionale de l'Ouest, Bobo-Dioulasso, Burkina Faso.""}, {'ForeName': 'Naomie', 'Initials': 'N', 'LastName': 'Kaboré', 'Affiliation': ""Institut de Recherche en Sciences de la Santé, Direction Régionale de l'Ouest, Bobo-Dioulasso, Burkina Faso.""}, {'ForeName': 'Jean Bosco', 'Initials': 'JB', 'LastName': 'Ouédraogo', 'Affiliation': ""Institut de Recherche en Sciences de la Santé, Direction Régionale de l'Ouest, Bobo-Dioulasso, Burkina Faso.""}]",The Pan African medical journal,['10.11604/pamj.2020.35.68.20849']
2548,32537097,Do caregivers' perspectives matter? Working alliances and treatment outcomes in trauma-focused cognitive behavioural therapy with children and adolescents.,"Background : Caregivers play a key role in the success of trauma-focused cognitive behavioural therapy (TF-CBT). Yet, the effect of their alliance on treatment outcomes besides the other parties in treatment has hardly been studied.  Objective : This study examined the working alliance (WA) of therapists, patients and caregivers in TF-CBT and its contribution on treatment outcome over time.  Methods : N = 76 children and adolescents (mean age = 12.66 years, range 7-17, M/F ratio: .43) participated in the TF-CBT arm of a randomized controlled trial. The WA was assessed with the Working Alliance Inventory Short Version (WAI-S) at two measurement points, while symptom level of posttraumatic stress symptoms (PTSS) was assessed with the Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA). Paired sample  t -tests, intraclass correlations (ICC), and mixed-effects regression models for longitudinal data were performed.  Results : The alliance rating was high across all informants, with caregivers achieving the highest rating. The average level of cross-informant agreement on the alliance was low between therapists and caregivers (ICC = .26) and moderate between therapists and patients (ICC =.65). A significant contribution of an alliance improvement to the reduction of PTSS over time was found in each of the two tested models: therapists with patients model ( b  = .682) and therapists with caregivers model ( b  = .807). However, these effects were not detected with all four perspectives in one comprehensive model.  Conclusion : In summary, the potential of caregivers' views should receive more attention in the therapeutic process of trauma-focused therapy.",2020,A significant contribution of an alliance improvement to the reduction of PTSS over time was found in each of the two tested models: therapists with patients model ( b  = .682) and therapists with caregivers model ( b  = .807).,"['12.66\xa0years, range 7-17, M/F ratio: .43) participated in the TF-CBT arm of a randomized controlled trial', 'N =\xa076 children and adolescents (mean age\xa0', 'children and adolescents']","['cognitive behavioural therapy (TF-CBT', 'cognitive behavioural therapy']","['alliance rating', 'Working Alliance Inventory Short Version (WAI-S', 'average level of cross-informant agreement', 'symptom level of posttraumatic stress symptoms (PTSS']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}]","[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}]",76.0,0.0505171,A significant contribution of an alliance improvement to the reduction of PTSS over time was found in each of the two tested models: therapists with patients model ( b  = .682) and therapists with caregivers model ( b  = .807).,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Loos', 'Affiliation': 'Department of Psychiatry and Psychotherapy II, University Clinic Ulm, Ulm, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Tutus', 'Affiliation': 'Department of Child and Adolescent Psychiatry/Psychotherapy, University Clinic Ulm, Ulm, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kilian', 'Affiliation': 'Department of Psychiatry and Psychotherapy II, University Clinic Ulm, Ulm, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Goldbeck', 'Affiliation': 'Department of Child and Adolescent Psychiatry/Psychotherapy, University Clinic Ulm, Ulm, Germany.'}]",European journal of psychotraumatology,['10.1080/20008198.2020.1753939']
2549,31803504,Tumour location and efficacy of first-line EGFR inhibitors in  KRAS/RAS  wild-type metastatic colorectal cancer: retrospective analyses of two phase II randomised Spanish TTD trials.,"Purpose


Metastatic colorectal cancer (mCRC) is a group of distinct diseases, with clinical and molecular differences between right-sided and left-sided tumours driving varying prognosis.
Methods


Patients with  KRAS / RAS -wild type (wt) mCRC treated in first line with epidermal growth factor receptor inhibitors (EGFR-Is) (cetuximab or panitumumab) plus oxaliplatin or irinotecan-based chemotherapy from two phase II randomised trials conducted by the Spanish Cooperative for the Treatment of Digestive Tumours group were included in this retrospective study. The main objective was to analyse the prognostic effect of primary tumour location on objective response rate (ORR), progression-free survival (PFS) and overall survival (OS).
Results


Patients with  KRAS -wt right-sided tumours (n=52) had significantly lower efficacy as compared with patients with  KRAS -wt left-sided tumours (n=209); confirmed ORR (25% vs 47%, respectively; OR 0.4, 95% CI 0.2 to 0.8, p=0.004); and shorter median PFS (7.2 vs 9.9 months; HR 0.6, 95% CI 0.4 to 0.9, p=0.0157) and OS (13.6 vs 27.7 months; HR 0.5, 95% CI 0.3 to 0.7, p<0.0001). Similar results were observed in the  RAS -wt populations. The further classification of left-sided tumours as colon or rectum delivered similar survival outcomes, as well as a tendency to diminished ORR in patients with rectum tumours.
Conclusion


We observed significantly improved efficacy outcomes in patients with  KRAS / RAS -wt mCRC treated with first-line EGFR-I plus chemotherapy in left-sided primary tumours as compared with right-sided primary tumours.
Trial registration numbers


NCT01161316 and NCT00885885.",2019,right-sided tumours (n=52) had significantly lower efficacy as compared with patients with  KRAS -wt,"['patients with rectum tumours', 'Methods\n\n\nPatients with  KRAS ', 'RAS  wild-type metastatic colorectal cancer', 'Patients with  KRAS -wt']","['epidermal growth factor receptor inhibitors (EGFR-Is) (cetuximab or panitumumab) plus oxaliplatin or irinotecan-based chemotherapy', 'first-line EGFR inhibitors']","['shorter median PFS', 'objective response rate (ORR), progression-free survival (PFS) and overall survival (OS', 'efficacy outcomes', 'ORR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034896', 'cui_str': 'Rectum structure'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}]","[{'cui': 'C1443775', 'cui_str': 'Epidermal growth factor receptor antagonist-containing product'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.122439,right-sided tumours (n=52) had significantly lower efficacy as compared with patients with  KRAS -wt,"[{'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Benavides', 'Affiliation': 'Medical Oncology Service, Hospital Universitario Regional y Virgen de la Victoria. IBIMA, Malaga, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Díaz-Rubio', 'Affiliation': 'Medical Oncology Service, Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Carrato', 'Affiliation': 'Ramón y Cajal University Hospital, IRYCIS, CIBERONIC, Alcala University, Madrid, Spain.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Abad', 'Affiliation': 'Medical Oncology Service, Hospital Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Guillén', 'Affiliation': 'Medical Oncology, Hospital Universitario Ramon y Cajal, Madrid, Madrid, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Garcia-Alfonso', 'Affiliation': 'Medical Oncology Service, Hospital General Universitario Gregorio Maranon, Madrid, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Gil', 'Affiliation': 'Medical Oncology Service, Hospital Universitario Regional y Virgen de la Victoria. IBIMA, Malaga, Spain.'}, {'ForeName': 'María Teresa', 'Initials': 'MT', 'LastName': 'Cano', 'Affiliation': 'Medical Oncology Service, Hospital Universitario Reina Sofía, Cordoba, Spain.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Safont', 'Affiliation': 'Medical Oncology Service, Hospital General Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Gravalos', 'Affiliation': 'Medical Oncology Service, Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Manzano', 'Affiliation': 'Medical Oncology Service, Hospital Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Sánchez', 'Affiliation': 'Medical Oncology Service, Hospital Universitario Puerta del Hierro Majadahonda, Madrid, Spain.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Alcaide', 'Affiliation': 'Medical Oncology Service, Hospital Costa del Sol, Málaga, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'López', 'Affiliation': 'Medical Oncology Service, University Hospital of Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Bartomeu', 'Initials': 'B', 'LastName': 'Massutí', 'Affiliation': 'Medical Oncology Service, Hospital General Universitario de Alicante, Alicante, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Sastre', 'Affiliation': 'Medical Oncology Service, Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Martínez', 'Affiliation': 'Medical Oncology Service, Hospital Universitario Marqués de Valdecilla, Santander, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Escudero', 'Affiliation': 'Medical Oncology Service, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Méndez', 'Affiliation': 'Medical Oncology Service, Hospital Universitario de Móstoles, Madrid, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Aranda', 'Affiliation': 'Medical Oncology Service, Hospital General Universitario Gregorio Maranon, Madrid, Spain.'}]",ESMO open,['10.1136/esmoopen-2019-000599']
2550,31811378,The effect of different imaging techniques for the visualisation of evidence in court on jury comprehension.,"Evidence presented within a courtroom should be clear so that the members of the jury can understand it. The presentation of distressing images, such as human remains, can have a negative effect on the jury since photographic images may evoke emotional responses. Therefore, it is important to understand how other visual mediums may improve comprehension, bias, or distress individuals. For this study, 91 individuals were randomly assigned one of three visual evidence formats in a mock courtroom exercise. These included photographs, 3D visualisations, or a 3D-printed model. The results show that the use of 3D imaging improves the juror's understanding of technical language used within a courtroom, which in turn better informs the juror's in their decision-making.",2020,"The results show that the use of 3D imaging improves the juror's understanding of technical language used within a courtroom, which in turn better informs the juror's in their decision-making.",['91 individuals'],['mock courtroom exercise'],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0562577', 'cui_str': 'Mocking'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",[],91.0,0.0432794,"The results show that the use of 3D imaging improves the juror's understanding of technical language used within a courtroom, which in turn better informs the juror's in their decision-making.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Errickson', 'Affiliation': 'Cranfield Forensic Institute, Defence Academy of the United Kingdom, Cranfield University, Shrivenham, SN6 8LA, UK. david.errickson@cranfield.ac.uk.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Fawcett', 'Affiliation': 'Department of Psychology, Manchester Metropolitan University, Manchester, M15 6BH, UK.'}, {'ForeName': 'T J U', 'Initials': 'TJU', 'LastName': 'Thompson', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Borough Road, Middlesbrough, TS1 3BA, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Campbell', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Borough Road, Middlesbrough, TS1 3BA, UK.'}]",International journal of legal medicine,['10.1007/s00414-019-02221-y']
2551,31811498,Feasibility of photobiomodulation therapy for the prevention of radiodermatitis: a single-institution pilot study.,"Acute radiodermatitis is one of the major complications when radiation therapy (RT) is delivered to the head and neck region in cases of head and neck cancers or lung cancers with supraclavicular lymph node metastasis. In these cases, high dose of RT is generally used so that acute radiodermatitis is observed in more than 90% of patients, and it negatively affects patients' quality of life. In this pilot study, we evaluated the clinical feasibility of photobiomodulation (PBM) therapy before conducting a randomized trial based on the hypothesis that PBM therapy may reduce the severity of radiodermatitis in participants receiving 60 Gy or higher dose. Patients who were to receive 60 Gy or higher dose in the neck were included in the study. Thirty-three patients received PBM therapy three times a week during RT. The severity of radiodermatitis was evaluated by two dermatologists and a radiation oncologist using the modified Common Terminology Criteria for Adverse Events (CTCAE). Patients were followed up until a week after RT. In all patients, 90.6% of planned PBM schedule was completed. There was no significant side effect of PBM therapy. Thirteen (39%) patients showed wet desquamation (CTCAE grade 2b or higher). Only three (9%) of them showed grade 3 toxicity, which is a favorable result compared with previous studies. This pilot study showed that PBM therapy is safe and feasible in the clinic, and it might reduce the severity of radiodermatitis. A randomized trial should be warranted to prove the efficacy of PBM therapy.",2020,There was no significant side effect of PBM therapy.,"['Patients who were to receive 60\xa0Gy or higher dose in the neck were included in the study', 'participants receiving 60\xa0Gy or higher dose']","['PBM therapy', 'radiation therapy (RT', 'photobiomodulation therapy', 'photobiomodulation (PBM) therapy']","['grade 3 toxicity', 'acute radiodermatitis', 'radiodermatitis', 'severity of radiodermatitis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0263606', 'cui_str': 'Early radiation dermatitis'}, {'cui': 'C0034561', 'cui_str': 'Radiation dermatitis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",33.0,0.0303413,There was no significant side effect of PBM therapy.,"[{'ForeName': 'Ji-Hye', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Dermatology, Samsung Medical Center, Sungkyunkwan University School of Medicine, #81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.'}, {'ForeName': 'Hyun Jeong', 'Initials': 'HJ', 'LastName': 'Byun', 'Affiliation': 'Department of Dermatology, Samsung Medical Center, Sungkyunkwan University School of Medicine, #81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.'}, {'ForeName': 'Jong Hee', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, Samsung Medical Center, Sungkyunkwan University School of Medicine, #81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.'}, {'ForeName': 'Haeyoung', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, #81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.'}, {'ForeName': 'Jae Myung', 'Initials': 'JM', 'LastName': 'Noh', 'Affiliation': 'Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, #81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.'}, {'ForeName': 'Cho Rok', 'Initials': 'CR', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Kye Dermatology Clinic, Seoul, Republic of Korea.'}, {'ForeName': 'Dongryul', 'Initials': 'D', 'LastName': 'Oh', 'Affiliation': 'Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, #81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea. dongryul.oh@samsung.com.'}]",Lasers in medical science,['10.1007/s10103-019-02930-1']
2552,31816446,Ustekinumab Pharmacokinetics and Exposure Response in a Phase 3 Randomized Trial of Patients With Ulcerative Colitis.,"BACKGROUND & AIMS


The efficacy of antibody-based therapeutics depends on their pharmacokinetics. The pharmacokinetic and exposure response profiles of ustekinumab, a monoclonal antibody against interleukin 12/interleukin 23, are known in patients with Crohn's disease, yet there are few data from patients with ulcerative colitis. We characterized ustekinumab's pharmacokinetics, exposure response, and optimal serum concentrations in patients with ulcerative colitis.
METHODS


We collected data from 2 phase 3 trials (1 induction and 1 maintenance), in which patients with moderate to severe ulcerative colitis received an intravenous induction dose of ustekinumab (130 mg, n = 320; or approximately 6 mg/kg, n = 322). Responders were assigned randomly to groups that received subcutaneous maintenance ustekinumab (90 mg) every 8 weeks (n = 176) or 12 weeks (n = 172), or placebo (n = 175). We evaluated the association between ustekinumab concentration and efficacy, based on clinical effects (Mayo score), histologic features, and inflammation (measurement of C-reactive protein, fecal calprotectin, and lactoferrin), as well as safety (infections, serious infections, or serious adverse events), during induction and maintenance therapy. Optimal serum concentrations of ustekinumab were identified using receiver operating characteristic curve analyses.
RESULTS


In patients with ulcerative colitis, dose-proportional serum concentrations of ustekinumab, unaffected by prior biologic or concomitant immunomodulator therapy, reached steady state by the second maintenance dose; the median trough concentration for dosing every 8 weeks was approximately 3-fold that of dosing every 12 weeks. Serum concentrations were associated with clinical and histologic features of efficacy and normalization of inflammation markers. The week-8 concentration threshold for induction of response was 3.7 μg/mL. A steady-state trough serum concentration of 1.3 μg/mL or higher was associated with a higher rate of clinical remission compared with patients who had lower serum concentrations. Serum concentrations of ustekinumab were not associated with infections, serious infections, or serious adverse events.
CONCLUSIONS


In an analysis of data from 2 phase 3 trials of patients with ulcerative colitis, we found that serum concentrations of ustekinumab were proportional to dose, unaffected by prior biologic or concomitant immunomodulator therapies, associated with clinical and histologic efficacy and markers of inflammation, and were not associated with safety events at doses evaluated. Ustekinumab pharmacokinetics are consistent between patients with Crohn's disease vs ulcerative colitis.",2019,"Serum concentrations of ustekinumab were not associated with infections, serious infections, or serious adverse events.
","['patients with ulcerative colitis', ""patients with Crohn's disease vs ulcerative colitis"", ""patients with Crohn's disease"", 'Patients With Ulcerative Colitis', 'patients with moderate to severe ulcerative colitis']","['subcutaneous maintenance ustekinumab', 'intravenous induction dose of ustekinumab', 'placebo']","['Serum concentrations of ustekinumab', 'Serum concentrations', 'rate of clinical remission', 'median trough concentration', 'clinical effects (Mayo score), histologic features, and inflammation (measurement of C-reactive protein, fecal calprotectin, and lactoferrin), as well as safety (infections, serious infections, or serious adverse events', 'serum concentrations of ustekinumab']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0729453,"Serum concentrations of ustekinumab were not associated with infections, serious infections, or serious adverse events.
","[{'ForeName': 'Omoniyi J', 'Initials': 'OJ', 'LastName': 'Adedokun', 'Affiliation': 'Janssen Research and Development, LLC, Spring House, Pennsylvania. Electronic address: OAdedoku@its.jnj.com.'}, {'ForeName': 'Zhenhua', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Janssen Research and Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Marano', 'Affiliation': 'Janssen Research and Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': ""O'Brien"", 'Affiliation': 'Janssen Research and Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Szapary', 'Affiliation': 'Janssen Research and Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Janssen Research and Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Jewel', 'Initials': 'J', 'LastName': 'Johanns', 'Affiliation': 'Janssen Research and Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Rupert W', 'Initials': 'RW', 'LastName': 'Leong', 'Affiliation': 'Concord and Macquarie University Hospitals, Sydney, Australia.'}, {'ForeName': 'Tadakazu', 'Initials': 'T', 'LastName': 'Hisamatsu', 'Affiliation': 'Kyorin University, Tokyo, Japan.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'van Assche', 'Affiliation': 'University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Danese', 'Affiliation': 'Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Abreu', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Bruce E', 'Initials': 'BE', 'LastName': 'Sands', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'University of California San Diego, La Jolla, California.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2019.11.059']
2553,32149709,First-in-human evaluation of a novel sirolimus-eluting ultra-high molecular weight APTITUDE bioresorbable scaffold: 9- and 24-month imaging and clinical results of the RENASCENT II trial.,"AIMS


The novel sirolimus-eluting ultra-high molecular weight APTITUDE bioreabsorbable vascular scaffold (BRS) displays higher mechanical strength, expansion capabilities and resistance to fracture compared to other BRS technologies. RENASCENT II is a prospective, multicentre first-in-human clinical study evaluating the clinical performance of the APTITUDE BRS in the treatment of single de novo coronary lesions among patients undergoing percutaneous coronary intervention.
METHODS AND RESULTS


The APTITUDE BRS was tested in a prospective study in two countries (Italy and Colombia). Study objectives were angiographic in-scaffold late lumen loss (IS-LLL) measured by quantitative coronary angiography (QCA) and target vessel failure (TVF) defined as the composite rate of cardiac death, target vessel myocardial infarction (TV-MI) or ischaemia-driven target lesion revascularisation (TLR) at 9 and 24 months. A total of 60 patients were enrolled. All patients underwent lesion predilatation and 46 patients (76.7%) underwent post-dilatation. Clinical device and procedural success were 98.3% (59/60 patients) and 100%, respectively. Angiographic late lumen loss was 0.19±0.26 mm at 9 months and 0.3±0.41 mm at 24 months. At 9 months, TVF occurred in 2/59 patients (3.4%) due to TV-MI but there was no TLR. No further cases of TVF, MACE or stent thrombosis were reported up to 24-month follow-up.
CONCLUSIONS


In this multicentre prospective study, the APTITUDE BRS was shown to be safe and effective in the treatment of single coronary lesions at 24-month clinical follow-up.",2020,"No further cases of TVF, MACE or stent thrombosis were reported up to 24-month follow-up.
","['bioresorbable scaffold', 'patients undergoing percutaneous coronary intervention', '60 patients were enrolled', 'two countries (Italy and Colombia']",[],"['quantitative coronary angiography (QCA) and target vessel failure (TVF) defined as the composite rate of cardiac death, target vessel myocardial infarction (TV-MI) or ischaemia-driven target lesion revascularisation (TLR', 'Clinical device and procedural success', 'Angiographic late lumen loss', 'TVF, MACE or stent thrombosis', 'TVF', 'TV-MI']","[{'cui': 'C0337143', 'cui_str': 'Scaffold'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C3245499', 'cui_str': 'Colombia'}]",[],"[{'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}]",60.0,0.0280157,"No further cases of TVF, MACE or stent thrombosis were reported up to 24-month follow-up.
","[{'ForeName': 'Alaide', 'Initials': 'A', 'LastName': 'Chieffo', 'Affiliation': 'IRCCS, San Raffaele Hospital, Milan, Italy.'}, {'ForeName': 'Saud Ahmed', 'Initials': 'SA', 'LastName': 'Khawaja', 'Affiliation': ''}, {'ForeName': 'Azeem', 'Initials': 'A', 'LastName': 'Latib', 'Affiliation': ''}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Vesga', 'Affiliation': ''}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Moncada', 'Affiliation': ''}, {'ForeName': 'Juan A', 'Initials': 'JA', 'LastName': 'Delgado', 'Affiliation': ''}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Fonseca', 'Affiliation': ''}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Testa', 'Affiliation': ''}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Esposito', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Ferrone', 'Affiliation': ''}, {'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Cortese', 'Affiliation': ''}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Maehara', 'Affiliation': ''}, {'ForeName': 'Juan F', 'Initials': 'JF', 'LastName': 'Granada', 'Affiliation': ''}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Colombo', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-19-00600']
2554,32545872,"Exercise before, during, and after Hospitalization for Allogeneic Hematological Stem Cell Transplant: A Feasibility Randomized Controlled Trial.","People with cancer who undergo allogeneic hematological stem cell transplant (allo-HSCT) experience significant deconditioning that can compromise quality of life. Exercise has shown to be beneficial before or after allo-HSCT; however, little is known about exercise therapy delivered across the continuum of care. We conducted a feasibility randomized controlled trial of exercise delivered prior to admission, during the inpatient stay, and after discharge versus control in people with planned allo-HSCT. Feasibility was assessed via recruitment and retention rates, the incidence of adverse events, and adherence to the exercise prescription. Estimates of efficacy were measured at baseline, one week prior to hospital admission, and 100 days and one year after transplant. The recruitment and retention rates were 20% and 33%, respectively. One serious adverse event occurred during the baseline six-minute walk test that precluded participation in the study and no adverse events were associated with the intervention. From baseline to pre-transplant, the intervention group improved six-minute walk test distances by 45 m (95% CI: -18.0 to 108.7)-a finding that warrants further investigation with an adequately powered trial. Our study contributes important feasibility considerations and pilot data for future exercise intervention research in allo-HSCT recipients.",2020,"From baseline to pre-transplant, the intervention group improved six-minute walk test distances by 45 m (95% CI: -18.0 to 108.7)-a finding that warrants further investigation with an adequately powered trial.","['People with cancer who undergo allogeneic hematological stem cell transplant (allo-HSCT) experience significant deconditioning', 'people with planned allo-HSCT', 'Allogeneic Hematological Stem Cell Transplant', 'allo-HSCT recipients']",[],"['via recruitment and retention rates, the incidence of adverse events, and adherence to the exercise prescription', 'recruitment and retention rates']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]",[],"[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0588464', 'cui_str': 'Exercise on prescription'}]",,0.163626,"From baseline to pre-transplant, the intervention group improved six-minute walk test distances by 45 m (95% CI: -18.0 to 108.7)-a finding that warrants further investigation with an adequately powered trial.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Santa Mina', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON M5S 2W6, Canada.'}, {'ForeName': 'Lianne B', 'Initials': 'LB', 'LastName': 'Dolan', 'Affiliation': 'Department of Supportive Care, Princess Margaret Cancer Centre, Toronto, ON M5G 2C1, Canada.'}, {'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Lipton', 'Affiliation': 'Faculty of Medicine, University of Toronto, Toronto, ON M5S 1A8, Canada.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Au', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON M5S 2W6, Canada.'}, {'ForeName': 'Encarna', 'Initials': 'E', 'LastName': 'Camacho Pérez', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON M5S 2W6, Canada.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Franzese', 'Affiliation': 'Department of Supportive Care, Princess Margaret Cancer Centre, Toronto, ON M5G 2C1, Canada.'}, {'ForeName': 'Shabbir M H', 'Initials': 'SMH', 'LastName': 'Alibhai', 'Affiliation': 'Department of Supportive Care, Princess Margaret Cancer Centre, Toronto, ON M5G 2C1, Canada.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Jones', 'Affiliation': 'Department of Supportive Care, Princess Margaret Cancer Centre, Toronto, ON M5G 2C1, Canada.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Chang', 'Affiliation': 'Department of Supportive Care, Princess Margaret Cancer Centre, Toronto, ON M5G 2C1, Canada.'}]",Journal of clinical medicine,['10.3390/jcm9061854']
2555,32545996,How Counseling Based on Acceptance and Commitment Therapy and Supported with Motivational Interviewing Affects Levels of Functional Recovery in Patients Diagnosed with Schizophrenia: A Quasi-Experimental Study.,"This study aimed to determine how counseling based on acceptance and commitment therapy (ACT) and supported with motivational interviewing (MIs) affected functional recovery in individuals diagnosed with schizophrenia (IDSs). A quasi-experimental design was used. The participants of this study were 87 individuals diagnosed with schizophrenia (36 in the experimental group and 51 in the control group). The experimental group received counseling based on ACT and supported with MIs. The data were collected between September 2018 and May 2019 using a Descriptive Information Form and the Functional Remission of General Schizophrenia Scale (FROGS). The participants in the experimental group were given a group counseling program of eight sessions at community mental health centers in downtown Malatya, Turkey. The results revealed a statistically significant difference in the mean scores on FROGS between those in the IDS experimental group and those in the control group. The scores increased on both groups.",2020,The scores increased on both groups.,"['87 individuals diagnosed with schizophrenia (36 in the experimental group and 51 in the control group', 'Patients Diagnosed with Schizophrenia', 'individuals diagnosed with schizophrenia (IDSs']","['counseling based on acceptance and commitment therapy (ACT) and supported with motivational interviewing (MIs', 'counseling based on ACT and supported with MIs', 'Motivational Interviewing']","['mean scores on FROGS', 'Functional Remission of General Schizophrenia Scale (FROGS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",87.0,0.0192765,The scores increased on both groups.,"[{'ForeName': 'Erman', 'Initials': 'E', 'LastName': 'Yıldız', 'Affiliation': 'Inönü University, Malatya, Turkey.'}, {'ForeName': 'Rukuye', 'Initials': 'R', 'LastName': 'Aylaz', 'Affiliation': 'Inönü University, Malatya, Turkey.'}]",Clinical nursing research,['10.1177/1054773820935592']
2556,32546012,An intervention designed to investigate habit formation in a novel health behaviour.,"Objectives:  Understanding how to help people form habits is important in improving health interventions. The impact of two behaviour change techniques on behaviour (cues and monitoring) was tested, and the role of psychosocial factors that may predict behaviour change and habit formation were investigated.  Methods:  Participants (N = 186) were randomised to one of six conditions (behaviour monitoring vs habit monitoring vs irrelevant behaviour monitoring and cued vs not cued) and instructed to engage in a specific, novel behaviour every day for the following 3 weeks. Participants completed measures of behaviour, habit strength, prospective memory, attitude, intention, self-efficacy and motivation at three time points (pre-, post- and one-week follow-up).  Results:  All participants increased habit strength and behaviour. Post-hoc, it was found that community members, compared to students, developed stronger habits and maintained the behaviour and habit strength at one-week follow-up. Intention, behaviour and habit strength post-intervention moderated behaviour and habit strength maintenance.  Conclusion:  This research furthers our understanding of how to help people form healthy habits. It was found that any intervention seems to be effective in forming a habit and changing behaviour. Moreover, intention, habit and behaviour were the most important predictors of behaviour change and habit formation maintenance.",2020,"Post-hoc, it was found that community members, compared to students, developed stronger habits and maintained the behaviour and habit strength at one-week follow-up.",['Methods:  Participants (N\u2009=\u2009186'],"['six conditions (behaviour monitoring vs habit monitoring vs irrelevant behaviour monitoring and cued vs not cued) and instructed to engage in a specific, novel behaviour']","['habit strength and behaviour', 'behaviour (cues and monitoring', 'behaviour, habit strength, prospective memory, attitude, intention, self-efficacy and motivation', 'behaviour change and habit formation maintenance', 'behaviour and habit strength']","[{'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0589154', 'cui_str': 'Prospective memory'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",186.0,0.0179179,"Post-hoc, it was found that community members, compared to students, developed stronger habits and maintained the behaviour and habit strength at one-week follow-up.","[{'ForeName': 'Enrique L P', 'Initials': 'ELP', 'LastName': 'Mergelsberg', 'Affiliation': 'Health Psychology & Behavioural Medicine Research Group, School of Psychology, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Mullan', 'Affiliation': 'Health Psychology & Behavioural Medicine Research Group, School of Psychology, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Allom', 'Affiliation': 'Health Psychology & Behavioural Medicine Research Group, School of Psychology, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Scott', 'Affiliation': 'Health Psychology & Behavioural Medicine Research Group, School of Psychology, Curtin University, Perth, Western Australia, Australia.'}]",Psychology & health,['10.1080/08870446.2020.1779272']
2557,32546013,"The effect of diagnostic terminology on cognitive, emotional, and post-concussive sequelae following mild brain injury.","Objective:  We sought to determine whether the diagnostic terms 'mild traumatic brain injury (mTBI)' and 'concussion' result in differences in perceived cognitive, emotional, and post-concussive sequelae. Method:  A total of 81 healthy university students (79% female; 69% of Asian descent) were randomly assigned to one of two conditions: mTBI ( n  = 41), or concussion ( n  = 40), and were instructed to simulate on a battery of cognitive (Neuropsychological Assessment Battery - Screening Module), emotional (Beck Anxiety Inventory, Beck Depression Inventory-II), and post-concussive (Rivermead Postconcussive Symptoms Questionnaire) measures. Results : There were no significant group differences between expected cognitive, emotional, or post-concussive consequences. However, both groups received poorer scores than the normative data. Conclusions:  These results suggest that diagnostic terminology does not appear to influence anticipated recovery following mild brain injury. However, the presentation of information about the injury itself may impact recovery outcomes. This study provides preliminary support for the potential negative effects that may arise as a result of providing participants with non-evidence based information about mild brain injuries.",2020,"There were no significant group differences between expected cognitive, emotional, or post-concussive consequences.","['81 healthy university students (79% female; 69% of Asian descent', 'mild brain injury']",[],"['expected cognitive, emotional, or post-concussive consequences', 'battery of cognitive (Neuropsychological Assessment Battery - Screening Module), emotional (Beck Anxiety Inventory, Beck Depression Inventory-II), and post-concussive (Rivermead Postconcussive Symptoms Questionnaire) measures']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}]",[],"[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",81.0,0.242062,"There were no significant group differences between expected cognitive, emotional, or post-concussive consequences.","[{'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Sekely', 'Affiliation': 'Graduate Department of Psychological Clinical Science, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Dhillon', 'Affiliation': 'Graduate Department of Psychological Clinical Science, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Konstantine K', 'Initials': 'KK', 'LastName': 'Zakzanis', 'Affiliation': 'Graduate Department of Psychological Clinical Science, University of Toronto, Toronto, Canada.'}]",Applied neuropsychology. Adult,['10.1080/23279095.2020.1775599']
2558,32549090,Novel Polymeric Lotion Formulation of Once-Daily Tazarotene (0.045%) for Moderate-to-Severe Acne: Pooled Phase 3 Analysis.,"Background: As current tazarotene formulations indicated for acne (0.1%) can cause irritation, a new tazarotene 0.045% lotion formu-lation was developed using polymeric emulsion technology. The objective was to assess efficacy, safety, and tolerability of tazarotene 0.045% lotion in patients with moderate-to-severe acne in a pooled analysis of data from two identical phase 3, double-blind, random-ized, vehicle-controlled 12-week clinical studies. Methods: Patients aged ≥9 years with moderate-to-severe acne were randomized (1:1) to tazarotene 0.045% lotion or vehicle lotion applied once daily. Inflammatory and noninflammatory lesion counts and Evaluator's Global Severity Score (EGSS) were assessed. Treatment success was defined as a ≥2-grade improvement in EGSS and a score of 'clear'/'almost clear'. Adverse events (AEs) and cutaneous safety and tolerability were also assessed. Results: In total, 1614 patients (mean age: 20.5 years) were randomized to tazarotene 0.045% lotion (n=799) or vehicle (n=815). At week 12, tazarotene 0.045% lotion demonstrated statistically significant superiority versus vehicle in reducing inflammatory and non-inflammatory lesion counts (least-squares mean percent changes from baseline: inflammatory, -57.9% vs -47.8% [P<0.001]; noninflam-matory, -56.0% vs -42.0% [P<0.001]). Treatment success at week 12 was also greater with tazarotene 0.045% lotion versus vehicle (30.4% vs 17.9%; P<0.001). The most frequent treatment-emergent AEs related to tazarotene treatment were application site pain (5.3%), dryness (3.6%), and exfoliation (2.1%). Conclusions: The new tazarotene 0.045% lotion formulated with polymeric emulsion technology demonstrated statistically signifi-cantly superior efficacy versus vehicle and was well tolerated in pediatric and adult patients with moderate-to-severe acne in this pooled analysis of 2 vehicle-controlled phase 3 studies. J Drugs Dermatol. 2020;19(3):272-279. doi:10.36849/JDD.2020.4869.",2020,The new tazarotene 0.045% lotion formulated with polymeric emulsion technology demonstrated statistically signifi-cantly superior efficacy versus vehicle and was well tolerated in pediatric and adult patients with moderate-to-severe acne in this pooled analysis of 2 vehicle-controlled phase 3 studies.,"['Methods: Patients aged ≥9 years with moderate-to-severe acne', '1614 patients (mean age: 20.5 years', 'pediatric and adult patients with moderate-to-severe acne', 'patients with moderate-to-severe acne in a pooled analysis of data from two identical phase 3, double-blind, random-ized, vehicle-controlled 12-week clinical studies']","['tazarotene 0.045% lotion or vehicle lotion', 'tazarotene 0.045% lotion']","[""≥2-grade improvement in EGSS and a score of 'clear'/'almost clear"", 'Adverse events (AEs) and cutaneous safety and tolerability', 'application site pain', ""Inflammatory and noninflammatory lesion counts and Evaluator's Global Severity Score (EGSS"", 'efficacy, safety, and tolerability', 'Treatment success', 'inflammatory and non-inflammatory lesion counts']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0288792', 'cui_str': 'tazarotene'}, {'cui': 'C4517410', 'cui_str': '0.045'}, {'cui': 'C0544341', 'cui_str': 'Lotion'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0521491', 'cui_str': 'Application site pain'}, {'cui': 'C0442743', 'cui_str': 'Noninflammatory'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3872830', 'cui_str': 'Inflammatory lesion'}]",1614.0,0.2744,The new tazarotene 0.045% lotion formulated with polymeric emulsion technology demonstrated statistically signifi-cantly superior efficacy versus vehicle and was well tolerated in pediatric and adult patients with moderate-to-severe acne in this pooled analysis of 2 vehicle-controlled phase 3 studies.,"[{'ForeName': 'Emil A', 'Initials': 'EA', 'LastName': 'Tanghetti', 'Affiliation': ''}, {'ForeName': 'William Philip', 'Initials': 'WP', 'LastName': 'Werschler', 'Affiliation': ''}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Lain', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Guenin', 'Affiliation': ''}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Harris', 'Affiliation': ''}, {'ForeName': 'Anya', 'Initials': 'A', 'LastName': 'Loncaric', 'Affiliation': ''}, {'ForeName': 'Radhakrishnan', 'Initials': 'R', 'LastName': 'Pillai', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849/JDD.2020.4869']
2559,32549100,Effects of Lidocaine Oropharyngeal Spray Applied Before Endotracheal Intubation on QT Dispersion in Patients Undergoing Coronary Artery Bypass Grafting: A Prospective Randomized Controlled Study.,"OBJECTIVE


To investigate the effects of lidocaine oropharyngeal spray applied before endotracheal intubation on hemodynamic responses and electrocardiographic parameters in patients undergoing coronary artery bypass grafting.
METHODS


A total of 60 patients who underwent coronary artery bypass grafting surgery were included in this prospective randomized controlled study. Patients were randomly divided into two groups, the topical lidocaine group (administration of 10% lidocaine oropharyngeal spray, five minutes before laryngoscopy and endotracheal intubation) and the control group. Both groups were compared with each other in terms of main hemodynamic parameters including mean arterial pressure and heart rate, as well as P and QT wave dispersion durations, before and after endotracheal intubation.
RESULTS


The groups were similar in terms of age, gender, and other demographics and basic clinical characteristics. There was a statistically significant difference between the groups in terms of QT dispersion durations after laryngoscopy and endotracheal intubation. The increase in QT dispersion duration was not statistically significant in the topical lidocaine group, whereas the increase in QT dispersion duration was statistically significant in the control group. When the groups were compared in terms of P wave dispersion durations, there were significant decreases in both groups, but there was no significant difference between the groups.
CONCLUSION


Our study revealed that the topical lidocaine administration before endotracheal intubation prevented increase of QT dispersion duration in patients undergoing coronary artery bypass grafting.
TRIAL REGISTRATION


NCT03304431.",2020,There was a statistically significant difference between the groups in terms of QT dispersion durations after laryngoscopy and endotracheal intubation.,"['60 patients who underwent', 'patients undergoing coronary artery bypass grafting', 'Patients Undergoing Coronary Artery Bypass Grafting']","['Lidocaine Oropharyngeal Spray Applied Before Endotracheal Intubation', 'endotracheal intubation', 'lidocaine oropharyngeal spray, five minutes before laryngoscopy and endotracheal intubation', 'lidocaine', 'topical lidocaine', 'coronary artery bypass grafting surgery', 'lidocaine oropharyngeal spray']","['QT dispersion durations', 'hemodynamic responses and electrocardiographic parameters', 'mean arterial pressure and heart rate, as well as P and QT wave dispersion durations', 'QT Dispersion', 'QT dispersion duration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0360097', 'cui_str': 'Lidocaine-containing product in cutaneous dose form'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0332624', 'cui_str': 'Dispersion'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]",60.0,0.0257983,There was a statistically significant difference between the groups in terms of QT dispersion durations after laryngoscopy and endotracheal intubation.,"[{'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Bilgi', 'Affiliation': 'Abant Izzet Baysal University Medical School Bolu Turkey Abant Izzet Baysal University Medical School, Bolu, Turkey.'}, {'ForeName': 'Yusuf', 'Initials': 'Y', 'LastName': 'Velioglu', 'Affiliation': 'Abant Izzet Baysal University Medical School Bolu Turkey Abant Izzet Baysal University Medical School, Bolu, Turkey.'}, {'ForeName': 'Hamit', 'Initials': 'H', 'LastName': 'Yoldas', 'Affiliation': 'Abant Izzet Baysal University Medical School Bolu Turkey Abant Izzet Baysal University Medical School, Bolu, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Cosgun', 'Affiliation': 'Abant Izzet Baysal University Medical School Bolu Turkey Abant Izzet Baysal University Medical School, Bolu, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Yuksel', 'Affiliation': 'Abant Izzet Baysal University Medical School Bolu Turkey Abant Izzet Baysal University Medical School, Bolu, Turkey.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Karagoz', 'Affiliation': 'Abant Izzet Baysal University Medical School Bolu Turkey Abant Izzet Baysal University Medical School, Bolu, Turkey.'}, {'ForeName': 'Isa', 'Initials': 'I', 'LastName': 'Yildiz', 'Affiliation': 'Abant Izzet Baysal University Medical School Bolu Turkey Abant Izzet Baysal University Medical School, Bolu, Turkey.'}, {'ForeName': 'Abdulhamit', 'Initials': 'A', 'LastName': 'Es', 'Affiliation': 'Abant Izzet Baysal University Faculty of Economics and Administrative Sciences Bolu Turkey Abant Izzet Baysal University Faculty of Economics and Administrative Sciences, Bolu, Turkey.'}, {'ForeName': 'Duygu', 'Initials': 'D', 'LastName': 'Caliskan', 'Affiliation': 'Abant Izzet Baysal University Medical School Bolu Turkey Abant Izzet Baysal University Medical School, Bolu, Turkey.'}, {'ForeName': 'Kemalettin', 'Initials': 'K', 'LastName': 'Erdem', 'Affiliation': 'Abant Izzet Baysal University Medical School Bolu Turkey Abant Izzet Baysal University Medical School, Bolu, Turkey.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Demirhan', 'Affiliation': 'Abant Izzet Baysal University Medical School Bolu Turkey Abant Izzet Baysal University Medical School, Bolu, Turkey.'}]",Brazilian journal of cardiovascular surgery,['10.21470/1678-9741-2019-0112']
2560,32549127,Does soft tissue mobilization assist static stretching to improve hamstring flexibility? A randomized controlled trial.,"Objectives Objective of the study is to investigate whether Soft tissue mobilization (STM) can assist with static stretching to improve hamstring flexibly. Methods The design of the study was repeated measure design. The study was conducted at the physical therapy laboratory of Jamia Hamdard University, New Delhi. Participants included 78 healthy males with hamstring tightness, randomly assigned to either the control group (static stretching) or the experimental group (STM and static stretching). The experimental group received five sets of four different STM techniques, followed by two sets of 30-s static stretches 3 days per week over the course of 12 weeks. The control group received 5 min of sham ultrasound with an inactive probe prior to static stretching. Active knee extension test (AKE) was the outcome measure. Results Both groups showed significant improvement in AKE compared with the baseline measurements. With ingroup analysis showed a significant difference in AKE across all measured time periods (weeks 4, 8, and 12) with pre-test in both groups (p<0.05). No significant difference in AKE improvement was found between groups (p>0.05). Conclusion The results of this study show that STM prior to static stretching does not significantly improve hamstring flexibility among healthy individuals. Although this study cannot be generalized, the results may be useful for evidence-based practice in the management of hamstring tightness.",2020,No significant difference in AKE improvement was found between groups (p>0.05).,"['Participants included 78 healthy males with hamstring tightness', 'Jamia Hamdard University, New Delhi', 'healthy individuals']","['5\xa0min of sham ultrasound with an inactive probe prior to static stretching', 'STM', 'Active knee extension test (AKE', 'Soft tissue mobilization (STM', 'control group (static stretching) or the experimental group (STM and static stretching']","['AKE', 'hamstring flexibility', 'AKE improvement']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0086541', 'cui_str': 'Dry form of cutaneous leishmaniasis'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C0686940', 'cui_str': 'Soft tissue mobilization'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",78.0,0.0356248,No significant difference in AKE improvement was found between groups (p>0.05).,"[{'ForeName': 'Shibili', 'Initials': 'S', 'LastName': 'Nuhmani', 'Affiliation': 'Physical Therapy Department, College of Applied Medical Sciences, Imam Abdulrahman Bin Faisal University, P.O. Box 2435, Dammam, 31451, Saudi Arabia.'}]",Journal of complementary & integrative medicine,['10.1515/jcim-2019-0288']
2561,32549135,Double-blind trial of solid lipid Boswellia serrata particles (SLBSP) vs. standardized Boswellia serrata gum extract (BSE) for osteoarthritis of knee.,"Present study was planned to investigate the efficacy of SLBSP vs. standardized BSE for symptomatic knee osteoarthritis (OA) treatment. It was prospective, randomized, double-blind, double-dummy, placebo-controlled, and single-centre clinical trial for symptomatic osteoarthritis of knee. Subjects were randomized to receive SLBSP capsule + BSE Placebo or BSE tablet + SLBSP placebo for two months. Patients were allowed to take rescue analgesics (Acelofenac 100 mg). Improvement in pain and function was assessed utilizing WOMAC, VAS. Level of CTX-II in urine and serum levels of inflammatory cytokines including IL-2, IL-4, IL-6, TNF-α, and IFN-γ were measured initially and at end of treatment. WOMAC and VAS score improved markedly in SLBSP as well as in BSE arm (p < 0.05). Difference in VAS and WOMAC scores between the two arms was not statistically significant. Most significant effect was observed in the need for rescue analgesics. SLBSP caused marked lowering of pro-inflammatory cytokines levels whereas a several fold increase was noted in the BSE arm (p < 0.05). Both groups showed marked improvement in pain, SLBSP being superior to BSE with respect to reducing the need for rescue analgesics in addition to modulating inflammatory cytokines.",2020,SLBSP caused marked lowering of pro-inflammatory cytokines levels whereas a several fold increase was noted in the BSE arm (p < 0.05).,"['symptomatic knee osteoarthritis (OA) treatment', 'osteoarthritis of knee', 'symptomatic osteoarthritis of knee']","['solid lipid Boswellia serrata particles (SLBSP) vs. standardized Boswellia serrata gum extract (BSE', 'SLBSP capsule\xa0+\xa0BSE Placebo or BSE tablet\xa0+\xa0SLBSP placebo', 'SLBSP', 'SLBSP vs. standardized BSE', 'placebo']","['WOMAC and VAS score', 'pain and function', 'VAS and WOMAC scores', 'Level of CTX-II in urine and serum levels of inflammatory cytokines including IL-2, IL-4, IL-6, TNF-α, and IFN-γ', 'pain, SLBSP', 'lowering of pro-inflammatory cytokines levels']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0873038', 'cui_str': 'boswellia preparation'}, {'cui': 'C0085105', 'cui_str': 'Breast self-examination'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0033382', 'cui_str': 'Proline'}]",,0.428873,SLBSP caused marked lowering of pro-inflammatory cytokines levels whereas a several fold increase was noted in the BSE arm (p < 0.05).,"[{'ForeName': 'Preeti D', 'Initials': 'PD', 'LastName': 'Kulkarni', 'Affiliation': 'School of Pharmacy and Medical Science, Singhania University, Pacheri Bari, Jhunjhunu, 333515,Rajasthan, India.'}, {'ForeName': 'Neena D', 'Initials': 'ND', 'LastName': 'Damle', 'Affiliation': 'Department of Kaya Chikitsa, DY Patil University, School of Ayurveda, Navi Mumbai, India.'}, {'ForeName': 'Sumer', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'School of Life Sciences, Singhania University, Jhunjhunu, Rajasthan, India.'}, {'ForeName': 'Krishnat S', 'Initials': 'KS', 'LastName': 'Yadav', 'Affiliation': 'Department of Biochemistry, Padmashree Dr. D Y Patil Medical College and Hospital, Navi Mumbai, India.'}, {'ForeName': 'Minal R', 'Initials': 'MR', 'LastName': 'Ghante', 'Affiliation': 'Sinhgad Technical Education Society, Smt. Kashibai Navale College of Pharmacy [Kondhwa], S. P. Pune University, Pune, India.'}, {'ForeName': 'Vaidhun H', 'Initials': 'VH', 'LastName': 'Bhaskar', 'Affiliation': 'Gahlot Institute of Pharmacy, Koparkhairane, Navi Mumbai, India.'}, {'ForeName': 'Lal', 'Initials': 'L', 'LastName': 'Hingorani', 'Affiliation': 'Pharmanza Herbal Pvt. Ltd., Dharmaj, Gujarat, India.'}, {'ForeName': 'Vikram S', 'Initials': 'VS', 'LastName': 'Gota', 'Affiliation': 'Department of Clinical Pharmacology, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre, Navi-Mumbai, India.'}]",Drug metabolism and personalized therapy,['10.1515/dmpt-2020-0104']
2562,32549522,"To examine serum paraoxonase 1 and 3 activities in benign and malignant diseases of the prostate, and changes in levels following robotic-assisted laparoscopic radical prostatectomy.","BACKGROUND/AIM


To examine serum paraoxonase 1 and 3 (PON1 and PON 3) activities in benign and malignant diseases of the prostate, to determine lipid profile and malondialdehyde (MDA) levels, and to investigate changes in levels following robotic-assisted laparoscopic radical prostatectomy (RALRP).
MATERIALS AND METHODS


137 patients, including a control group, were enrolled in the study. These were assigned into four groups. Group 1 (n=33) consisted of previously undergoing RALRP with no recurrence, Group 2 (n=36) of patients diagnosed with prostate cancer (PCa) and undergoing RALRP, and Group 3 (n=34) of patients diagnosed with benign prostatic hyperplasia. The control group (n=34) consisted of healthy individuals. Serum Low-Density Lipoprotein (LDL), High-Density Lipoprotein (HDL), triglyceride, cholesterol, prostate-specific antigen (PSA), PON1, PON3, and MDA values were measured. In addition, Group 2 MDA, PON1, PON3, and PON1/HDL levels were investigated preoperatively and at the first month postoperatively.
RESULTS


Significant changes were determined in PON1, PON3 and MDA levels. PON1 and PON3 levels decreased significantly in patients with PCa, while MDA levels increased. PON1 and PON3 increased postoperatively in the PCa group, while MDA decreased. BPH group PON1, PON3 and MDA levels were higher than those of the control group.
CONCLUSION


An increase in free oxygen radicals in the body or a decrease in endogenous antioxidant enzyme levels can result in malignant and benign diseases of the prostate. Surgical excision of malignant tissue in PCa causes a decrease in oxidative stress.",2020,"BPH group PON1, PON3 and MDA levels were higher than those of the control group.
","['Group 1 (n=33) consisted of previously undergoing RALRP with no recurrence, Group 2 (n=36) of patients diagnosed with prostate cancer (PCa) and undergoing RALRP, and Group 3 (n=34) of patients diagnosed with benign prostatic hyperplasia', '137 patients, including a control group, were enrolled in the study']","['robotic-assisted laparoscopic radical prostatectomy (RALRP', 'robotic-assisted laparoscopic radical prostatectomy']","['Serum Low-Density Lipoprotein (LDL), High-Density Lipoprotein (HDL), triglyceride, cholesterol, prostate-specific antigen (PSA), PON1, PON3, and MDA values', 'free oxygen radicals', 'PON1 and PON3 levels', 'oxidative stress', 'endogenous antioxidant enzyme levels', 'BPH group PON1, PON3 and MDA levels', 'MDA, PON1, PON3, and PON1/HDL levels', 'PON1 and PON3', 'MDA levels', 'PON1, PON3 and MDA levels', 'lipid profile and malondialdehyde (MDA) levels']","[{'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0162772', 'cui_str': 'Oxygen Species, Reactive'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0014440', 'cui_str': 'Enzyme measurement'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0523753', 'cui_str': 'Lipoproteins measurement'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}]",137.0,0.0348667,"BPH group PON1, PON3 and MDA levels were higher than those of the control group.
","[{'ForeName': 'Fevzİ', 'Initials': 'F', 'LastName': 'Bedİr', 'Affiliation': ''}, {'ForeName': 'HÜseyİn', 'Initials': 'H', 'LastName': 'KocatÜrk', 'Affiliation': ''}, {'ForeName': 'Mehmet Sefa', 'Initials': 'MS', 'LastName': 'Altay', 'Affiliation': ''}, {'ForeName': 'Engİn', 'Initials': 'E', 'LastName': 'Şebİn', 'Affiliation': ''}, {'ForeName': 'Banu', 'Initials': 'B', 'LastName': 'Bedİr', 'Affiliation': ''}]",Turkish journal of medical sciences,['10.3906/sag-2004-353']
2563,32549568,EVALUATION OF THE INTER- AND INTRAINDIVIDUAL AGREEMENT OF A PODODERMATITIS SCORING MODEL IN GREATER FLAMINGOS ( PHOENICOPTERUS ROSEUS ).,"Pododermatitis is an important cause of morbidity and mortality in flamingos under human care; management and treatment options vary widely based on subjective assessment from veterinarians or animal care staff (ACS). The objective of this study was to evaluate the agreement of pododermatitis severity scores assigned by veterinarians, ACS, and veterinary students when given a standardized rubric. Twenty-four greater flamingos ( Phoenicopterus roseus ) from a single zoo-managed flock were evaluated over time for pododermatitis. The individual feet of each bird were imaged, blinded, randomized, and scored for hyperkeratosis, fissures, nodules, papillomatous growth, and overall subjective score by seven evaluators (three veterinary specialists, two ACS, and two veterinary students) using a previously established flamingo pododermatitis scoring rubric. Interindividual reliability between evaluators and intraindividual agreement among specialists was determined. Reliable interindividual agreement was seen for fissures (Krippendorff's α [KA] = 0.807) between all seven evaluators, whereas the other individual lesions had very low reliability. Between the specialists, fissures had low interindividual reliability (KA = 0.782). Two specialists had strong intraindividual agreement for fissure score and one specialist had strong intraindividual agreement for overall subjective score (Cohen's κ [CK] 0.8-0.9,  P  < 0.01). Hyperkeratosis, papillomatous growth, nodules, and overall subjective score had low to moderate inter- and intraindividual reliability or agreement (KA, 0.06-0.49; CK, 0.02-0.8). In conclusion, the current scoring method for flamingo pododermatitis does not supply a reliable method for tracking foot health based on images alone across timepoints, except for fissures. Further analysis of the scoring system being used during a physical examination is warranted.",2020,Reliable interindividual agreement was seen for fissures,[],[],"['overall subjective score', 'Interindividual reliability', 'Hyperkeratosis, papillomatous growth, nodules, and overall subjective score', 'fissure score']",[],[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0870082', 'cui_str': 'Hyperkeratosis'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0028259', 'cui_str': 'Nodule'}, {'cui': 'C0332469', 'cui_str': 'Fissure'}]",,0.0247055,Reliable interindividual agreement was seen for fissures,"[{'ForeName': 'Joanna K', 'Initials': 'JK', 'LastName': 'Webb', 'Affiliation': 'Department of Veterinary Clinical Medicine, University of Illinois College of Veterinary Medicine, Urbana, Illinois 61802, USA.'}, {'ForeName': 'Krista A', 'Initials': 'KA', 'LastName': 'Keller', 'Affiliation': 'Department of Veterinary Clinical Medicine, University of Illinois College of Veterinary Medicine, Urbana, Illinois 61802, USA, kak@illinois.edu.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Welle', 'Affiliation': 'Department of Veterinary Clinical Medicine, University of Illinois College of Veterinary Medicine, Urbana, Illinois 61802, USA.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Allender', 'Affiliation': 'Department of Veterinary Clinical Medicine, University of Illinois College of Veterinary Medicine, Urbana, Illinois 61802, USA.'}]",Journal of zoo and wildlife medicine : official publication of the American Association of Zoo Veterinarians,['10.1638/2019-0219']
2564,32549659,Randomized controlled trial to compare outcomes with and without the enhanced recovery after surgery protocol in patients undergoing radical cystectomy.,"Introduction


Very few randomized controlled trials are available globally to support routine use of enhanced recovery after surgery (ERAS) protocol after radical cystectomy (RC), and none so far has been conducted in the Indian subcontinent. The aim of the present study was to evaluate hospital stay and 30-day perioperative outcomes following RC with the implementation of the ERAS protocol.
Materials and Methods


Fifty-four patients undergoing open RC were randomized to ERAS versus conventional surgical care (CSC) at our center from April 2017 to May 2018. Key interventions included avoidance of mechanical bowel preparation, early nasogastric tube removal, early enteral feeding, and early obligatory ambulation. Follow-up was done till 30-day postoperatively or till discharge, whichever longer.
Results


Twenty-seven patients in each group were analyzed. The demographic profile of the groups was similar. Length of stay in each group (8 days [5-57] ERAS vs. 9 days [5-31] CSC group,  P  = 0.390) was similar, with time to recovery of bowel function being significantly less in ERAS group (12 h [12-108] vs. 36 h [12-60] for bowel sounds [P = 0.001], 48 h [12-108] vs. 72 h [36-156] for passage of flatus [P = 0.001], and 84 h [36-180] vs. 96 [60-156] for passage of stools [P = 0.013]). Perioperative complication rate (12 patients (44.4%) vs. 14 (51.9%),  P  = 0.786) was similar.
Conclusions


ERAS protocol leads to faster bowel recovery compared to conventional care in patients undergoing open RC but fails to demonstrate a shorter length of stay and lower complication rate.",2020,"Perioperative complication rate (12 patients (44.4%) vs. 14 (51.9%),  P  = 0.786) was similar.
","['patients undergoing radical cystectomy', 'patients undergoing open RC', 'Materials and Methods\n\n\nFifty-four patients undergoing open RC']","['surgery (ERAS) protocol after radical cystectomy (RC', 'ERAS versus conventional surgical care (CSC']","['Length of stay', 'time to recovery of bowel function', 'hospital stay and 30-day perioperative outcomes', 'shorter length of stay and lower complication rate', 'Perioperative complication rate', 'avoidance of mechanical bowel preparation, early nasogastric tube removal, early enteral feeding, and early obligatory ambulation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517807', 'cui_str': '54'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0204823', 'cui_str': 'Nasogastric tube removal'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]",54.0,0.194586,"Perioperative complication rate (12 patients (44.4%) vs. 14 (51.9%),  P  = 0.786) was similar.
","[{'ForeName': 'Devanshu', 'Initials': 'D', 'LastName': 'Bansal', 'Affiliation': 'Department of Urology, Uro-Oncology and Renal Transplant, Max Super Speciality Hospital, New Delhi, India.'}, {'ForeName': 'Brusabhanu', 'Initials': 'B', 'LastName': 'Nayak', 'Affiliation': 'Department of Urology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Prabhjot', 'Initials': 'P', 'LastName': 'Singh', 'Affiliation': 'Department of Urology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rishi', 'Initials': 'R', 'LastName': 'Nayyar', 'Affiliation': 'Department of Urology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rashmi', 'Initials': 'R', 'LastName': 'Ramachandran', 'Affiliation': 'Department of Anesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Department of Urology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Amlesh', 'Initials': 'A', 'LastName': 'Seth', 'Affiliation': 'Department of Urology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}]",Indian journal of urology : IJU : journal of the Urological Society of India,['10.4103/iju.IJU_11_20']
2565,29959661,Offspring Personality Mediates the Association between Maternal Depression and Childhood Psychopathology.,"Offspring of mothers diagnosed with major depression are at increased risk for a wide range of psychological problems. Previous research has shown that individual differences in personality development can be informative for predicting risk and resilience to psychopathology, especially within at-risk populations. In the present study, we examined whether individual differences in offspring personality development during early to middle childhood could account for the association between maternal depression and offspring behavior problems later in childhood. Participants included 64 offspring of mothers diagnosed with major depression and 68 offspring of healthy comparison mothers. Personality was assessed via parent report at ages 3, 4, 5, and 9. Offspring internalizing and externalizing symptoms were assessed at age 9 via parent and teacher report. Results of latent growth curve models indicated that offspring Neuroticism, Conscientiousness, and Agreeableness mediated the link between early maternal depression and later childhood behavior problems, though results varied across maternal and teacher reports. Findings suggest that individual differences in youth personality and personality development are important predictors of emerging psychopathology among offspring of mothers diagnosed with depression.",2019,Offspring of mothers diagnosed with major depression are at increased risk for a wide range of psychological problems.,"['Participants included 64 offspring of mothers diagnosed with major depression and 68 offspring of healthy comparison mothers', 'Offspring of mothers diagnosed with major depression']",[],['Offspring internalizing and externalizing symptoms'],"[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]",[],"[{'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0191916,Offspring of mothers diagnosed with major depression are at increased risk for a wide range of psychological problems.,"[{'ForeName': 'Timothy A', 'Initials': 'TA', 'LastName': 'Allen', 'Affiliation': 'Centre for Addiction and Mental Health, Campbell Family Mental Health Research Institute, 33 Russell Street Suite 1028, Toronto, ON, M5S 2S1, Canada. timothy.allen@camh.ca.'}, {'ForeName': 'Assaf', 'Initials': 'A', 'LastName': 'Oshri', 'Affiliation': 'Department of Human Development and Family Science, University of Georgia, Athens, GA, USA.'}, {'ForeName': 'Fred A', 'Initials': 'FA', 'LastName': 'Rogosch', 'Affiliation': 'Mt. Hope Family Center, University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Sheree L', 'Initials': 'SL', 'LastName': 'Toth', 'Affiliation': 'Mt. Hope Family Center, University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Dante', 'Initials': 'D', 'LastName': 'Cicchetti', 'Affiliation': 'Institute of Child Development, University of Minnesota-Twin Cities, Minneapolis, MN, USA.'}]",Journal of abnormal child psychology,['10.1007/s10802-018-0453-3']
2566,31118201,Toward Personalized Computer Simulation of Breast Cancer Treatment: A Multiscale Pharmacokinetic and Pharmacodynamic Model Informed by Multitype Patient Data.,"The usefulness of mechanistic models to disentangle complex multiscale cancer processes, such as treatment response, has been widely acknowledged. However, a major barrier for multiscale models to predict treatment outcomes in individual patients lies in their initialization and parametrization, which needs to reflect individual cancer characteristics accurately. In this study, we use multitype measurements acquired routinely on a single breast tumor, including histopathology, MRI, and molecular profiling, to personalize parts of a complex multiscale model of breast cancer treated with chemotherapeutic and antiangiogenic agents. The model accounts for drug pharmacokinetics and pharmacodynamics. We developed an open-source computer program that simulates cross-sections of tumors under 12-week therapy regimens and used it to individually reproduce and elucidate treatment outcomes of 4 patients. Two of the tumors did not respond to therapy, and model simulations were used to suggest alternative regimens with improved outcomes dependent on the tumor's individual characteristics. It was determined that more frequent and lower doses of chemotherapy reduce tumor burden in a low proliferative tumor while lower doses of antiangiogenic agents improve drug penetration in a poorly perfused tumor. Furthermore, using this model, we were able to correctly predict the outcome in another patient after 12 weeks of treatment. In summary, our model bridges multitype clinical data to shed light on individual treatment outcomes. SIGNIFICANCE: Mathematical modeling is used to validate possible mechanisms of tumor growth, resistance, and treatment outcome.",2019,We developed an open-source computer program that simulates cross-sections of tumors under 12-week therapy regimens and used it to individually reproduce and elucidate treatment outcomes of 4 patients.,"['4 patients', 'Breast Cancer Treatment']","['chemotherapeutic and antiangiogenic agents', 'chemotherapy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0003392', 'cui_str': 'Antineoplastic agent'}, {'cui': 'C0596087', 'cui_str': 'Angiogenesis inhibitor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.0123094,We developed an open-source computer program that simulates cross-sections of tumors under 12-week therapy regimens and used it to individually reproduce and elucidate treatment outcomes of 4 patients.,"[{'ForeName': 'Xiaoran', 'Initials': 'X', 'LastName': 'Lai', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Oliver M', 'Initials': 'OM', 'LastName': 'Geier', 'Affiliation': 'Department of Diagnostic Physics, Clinic of Radiology and Nuclear Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Fleischer', 'Affiliation': 'Department of Genetics, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Øystein', 'Initials': 'Ø', 'LastName': 'Garred', 'Affiliation': 'Department of Pathology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Borgen', 'Affiliation': 'Department of Pathology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Simon W', 'Initials': 'SW', 'LastName': 'Funke', 'Affiliation': 'Center for Biomedical Computing, Simula Research Laboratory, Lysaker, Norway.'}, {'ForeName': 'Surendra', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Department of Genetics, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Marie E', 'Initials': 'ME', 'LastName': 'Rognes', 'Affiliation': 'Center for Biomedical Computing, Simula Research Laboratory, Lysaker, Norway.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Seierstad', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Anne-Lise', 'Initials': 'AL', 'LastName': 'Børresen-Dale', 'Affiliation': 'Department of Genetics, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Vessela N', 'Initials': 'VN', 'LastName': 'Kristensen', 'Affiliation': 'Department of Genetics, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Olav', 'Initials': 'O', 'LastName': 'Engebraaten', 'Affiliation': 'Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Köhn-Luque', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Arnoldo', 'Initials': 'A', 'LastName': 'Frigessi', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Faculty of Medicine, University of Oslo, Oslo, Norway. arnoldo.frigessi@medisin.uio.no.'}]",Cancer research,['10.1158/0008-5472.CAN-18-1804']
2567,30799257,"Darolutamide for non-metastatic, castration-resistant prostate cancer.",,2019,,"['non-metastatic, castration-resistant prostate cancer']",['Darolutamide'],[],"[{'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}]","[{'cui': 'C4547776', 'cui_str': 'darolutamide'}]",[],,0.0205259,,"[{'ForeName': 'Talha', 'Initials': 'T', 'LastName': 'Burki', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30102-0']
2568,31005828,"""There are carers, and then there are carers who actually care""; Conceptualizations of care among looked after children and care leavers, social workers and carers.","BACKGROUND


Looked after children and care leavers (LACCL) are some of the most vulnerable and marginalized young people in our communities. Existing research demonstrates that this group often interprets care in terms of genuineness and tends to feel uncared for. Less work exists from the perspective of social workers and formal carers.
OBJECTIVE


This study aims to explore how care is perceived and practiced among LACCL and those with a duty of care for them. We use a theoretical lens of care ethics to compare and contrast understandings in order to explore how they affect the delivery and receipt of care.
PARTICIPANTS & SETTING


There were 44 participants from four local authorities in north-east England including nineteen LACCL aged 12-20, eight social workers, and nineteen formal carers.
METHOD


Twenty-eight semi-structured 1:1 interviews, four dyad interviews and three focus group interviews.
RESULTS


LACCL desired care that felt familial, went beyond minimum standards and involved understanding. Social workers had to manage LACCL expectations and build relationships by both rationing care according to role constraints whilst sometimes going 'above and beyond' statutory care. Carers conceptualized care in terms of dedication and discipline but felt limited in their ability to achieve care in this way.
CONCLUSION


Bridging different conceptualizations of care is necessary to achieve integrated support for these vulnerable young people whilst also helping them to develop key skills for later adult life. A deeper understanding of frameworks of care has implications for social worker and formal carer training and practice.",2019,"Carers conceptualized care in terms of dedication and discipline but felt limited in their ability to achieve care in this way.
","['Twenty-eight semi-structured 1:1 interviews, four dyad interviews and three focus group interviews', 'There were 44 participants from four local authorities in north-east England including nineteen LACCL aged 12-20, eight social workers, and nineteen formal carers']",[],[],"[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0911524', 'cui_str': 'AM 44'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4749226', 'cui_str': 'Aging out of youth care system'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037444', 'cui_str': 'Social worker'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]",[],[],44.0,0.0285796,"Carers conceptualized care in terms of dedication and discipline but felt limited in their ability to achieve care in this way.
","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Brown', 'Affiliation': 'Institute of Health and Society, Newcastle University, Medical Faculty, Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK. Electronic address: rebecca.brown@newcastle.ac.uk.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Alderson', 'Affiliation': 'Faculty of Medicine, University of New South Wales, Level 8, The Bright Alliance, High St & Avoca Street, Randwick, NSW 2031, Australia. Electronic address: hayley.alderson@newcastle.ac.uk.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Kaner', 'Affiliation': 'Institute of Health and Society, Newcastle University, Medical Faculty, Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'McGovern', 'Affiliation': 'Institute of Health and Society, Newcastle University, Medical Faculty, Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK.'}, {'ForeName': 'Raghu', 'Initials': 'R', 'LastName': 'Lingam', 'Affiliation': 'Faculty of Medicine, University of New South Wales, Level 8, The Bright Alliance, High St & Avoca Street, Randwick, NSW 2031, Australia.'}]",Child abuse & neglect,['10.1016/j.chiabu.2019.03.018']
2569,30577902,Initiating methadone in jail and in the community: Patient differences and implications of methadone treatment for reducing arrests.,"The extent to which patient characteristics differ between individuals entering methadone treatment through community programs and jail-based programs is not known. Such differences could impact the likelihood of relapse and recidivism in these two populations and inform efforts at targeting interventions. We compared treatment-entry characteristics of participants enrolling in methadone treatment in two studies conducted in Baltimore, one conducted in community programs (N = 295) and the other in a jail-based program (N = 225). Controlling for age, race, and gender, individuals starting methadone treatment in jail compared to the community, had more severe drug use and criminal justice profiles. These different characteristics suggest that patients initiating methadone in a jail-based program could have greater likelihood of future arrest compared to patients entering community-based treatment. CLINICAL TRIALS REGISTRATION: Clinicaltrials.gov NCT 02334215 and NCT 01442493.",2019,The extent to which patient characteristics differ between individuals entering methadone treatment through community programs and jail-based programs is not known.,"['participants enrolling in methadone treatment in two studies conducted in Baltimore, one conducted in community programs (N\u202f=\u202f295) and the other in a jail-based program (N\u202f=\u202f225']",['methadone'],[],"[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4517652', 'cui_str': '225'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}]",[],,0.0480546,The extent to which patient characteristics differ between individuals entering methadone treatment through community programs and jail-based programs is not known.,"[{'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Schwartz', 'Affiliation': 'Friends Research Institute, Baltimore, MD, USA. Electronic address: rschwartz@friendsresearch.org.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Kelly', 'Affiliation': 'Friends Research Institute, Baltimore, MD, USA.'}, {'ForeName': 'Shannon Gwin', 'Initials': 'SG', 'LastName': 'Mitchell', 'Affiliation': 'Friends Research Institute, Baltimore, MD, USA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Gryczynski', 'Affiliation': 'Friends Research Institute, Baltimore, MD, USA.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': ""O'Grady"", 'Affiliation': 'Department of Psychology, University of Maryland, College Park, College Park, MD, USA.'}, {'ForeName': 'Jerome H', 'Initials': 'JH', 'LastName': 'Jaffe', 'Affiliation': 'Friends Research Institute, Baltimore, MD, USA.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2018.11.006']
2570,30660638,Gamma tocopherol effect on LPS-induced sputum neutrophilia is not modified by BMI or GSTM1 genotype.,,2019,,[],[],[],[],[],[],,0.0190887,,"[{'ForeName': 'Amika K', 'Initials': 'AK', 'LastName': 'Sood', 'Affiliation': 'Center for Environmental Medicine, Asthma, and Lung Biology, University of North Carolina, Chapel Hill, NC; Division of Allergy, Immunology and Rheumatology, Department of Pediatrics, University of North Carolina, Chapel Hill, NC. Electronic address: amika_sood@med.unc.edu.'}, {'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Burbank', 'Affiliation': 'Center for Environmental Medicine, Asthma, and Lung Biology, University of North Carolina, Chapel Hill, NC; Division of Allergy, Immunology and Rheumatology, Department of Pediatrics, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Charity G', 'Initials': 'CG', 'LastName': 'Duran', 'Affiliation': 'Center for Environmental Medicine, Asthma, and Lung Biology, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Enders', 'Affiliation': 'Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Center for Environmental Medicine, Asthma, and Lung Biology, University of North Carolina, Chapel Hill, NC; Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Peden', 'Affiliation': 'Center for Environmental Medicine, Asthma, and Lung Biology, University of North Carolina, Chapel Hill, NC; Division of Allergy, Immunology and Rheumatology, Department of Pediatrics, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Hernandez', 'Affiliation': 'Center for Environmental Medicine, Asthma, and Lung Biology, University of North Carolina, Chapel Hill, NC; Division of Allergy, Immunology and Rheumatology, Department of Pediatrics, University of North Carolina, Chapel Hill, NC.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2018.12.1009']
2571,30682460,ADRB2 p.Thr164Ile association with hospitalization depends upon asthma severity.,,2019,,[],[],[],[],[],[],,0.0166709,,"[{'ForeName': 'Lynn D', 'Initials': 'LD', 'LastName': 'Condreay', 'Affiliation': 'GlaxoSmithKline, Research Triangle Park, NC; PAREXEL International, Durham, NC. Electronic address: Lynn.Condreay@parexel.com.'}, {'ForeName': 'Mathias N', 'Initials': 'MN', 'LastName': 'Chiano', 'Affiliation': 'GlaxoSmithKline, Stevenage, United Kingdom.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'PAREXEL International, Durham, NC.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Harris', 'Affiliation': 'GlaxoSmithKline, Research Triangle Park, NC; PAREXEL International, Durham, NC.'}, {'ForeName': 'Dana J', 'Initials': 'DJ', 'LastName': 'Fraser', 'Affiliation': 'PAREXEL International, Durham, NC.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Meyers', 'Affiliation': 'University of Arizona College of Medicine, Tucson, Ariz.'}, {'ForeName': 'Eugene R', 'Initials': 'ER', 'LastName': 'Bleecker', 'Affiliation': 'University of Arizona College of Medicine, Tucson, Ariz.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Crim', 'Affiliation': 'GlaxoSmithKline, Research Triangle Park, NC.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Stempel', 'Affiliation': 'GlaxoSmithKline, Research Triangle Park, NC; Propeller Health, Madison, Wis.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Yancey', 'Affiliation': 'GlaxoSmithKline, Research Triangle Park, NC.'}, {'ForeName': 'Soumitra', 'Initials': 'S', 'LastName': 'Ghosh', 'Affiliation': 'GlaxoSmithKline, King of Prussia, Pa.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.01.012']
2572,30703387,Modulation of inflammatory gene transcripts in psoriasis vulgaris: Differences between ustekinumab and etanercept.,,2019,,['psoriasis vulgaris'],['ustekinumab and etanercept'],[],"[{'cui': 'C0263361', 'cui_str': 'Psoriasis vulgaris'}]","[{'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}]",[],,0.0297121,,"[{'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Brodmerkel', 'Affiliation': 'Immunology Biomarkers, Janssen Research & Development, Spring House, Pa.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Immunology Biomarkers, Janssen Research & Development, Spring House, Pa.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Garcet', 'Affiliation': 'Laboratory for Investigative Dermatology, The Rockefeller University, New York, NY.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hayden', 'Affiliation': 'Immunology Biomarkers, Janssen Research & Development, Spring House, Pa.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Chiricozzi', 'Affiliation': 'Institute of Dermatology, Catholic University - Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Inna', 'Initials': 'I', 'LastName': 'Novitskaya', 'Affiliation': 'Laboratory for Investigative Dermatology, The Rockefeller University, New York, NY.'}, {'ForeName': 'Judilyn', 'Initials': 'J', 'LastName': 'Fuentes-Duculan', 'Affiliation': 'Laboratory for Investigative Dermatology, The Rockefeller University, New York, NY.'}, {'ForeName': 'Mayte', 'Initials': 'M', 'LastName': 'Suarez-Farinas', 'Affiliation': 'Department of Population Health Science and Policy, Icahn Institute for Genomics and Multiscale Biology, Icahn School of Medicine at Mount Sinai, New York, NY; Department of Genetics and Genomics Science, Icahn Institute for Genomics and Multiscale Biology, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Campbell', 'Affiliation': 'Immunology Biomarkers, Janssen Research & Development, Spring House, Pa.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Krueger', 'Affiliation': 'Laboratory for Investigative Dermatology, The Rockefeller University, New York, NY. Electronic address: jgk@rockefeller.edu.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.01.017']
2573,32546490,"Cost-utility analysis of antibiotic treatment in patients with chronic low back pain and Modic changes: results from a randomised, placebo-controlled trial in Norway (the AIM study).","OBJECTIVE


To evaluate the cost-utility of 100 days of antibiotics in patients with chronic low back pain (LBP) and type I or II Modic changes included in the Antibiotic treatment In patients with chronic low back pain and Modic changes (AIM) study.
DESIGN


A cost-utility analysis from a societal and healthcare perspective alongside a double-blinded, parallel group, placebo, multicentre trial.
SETTING


Hospital outpatient clinics at six hospitals in Norway. The main results from the AIM study showed a small effect in back-related disability in favour of the antibiotics group, and slightly larger in those with type I Modic changes, but this effect was below the pre-defined threshold for clinically relevant effect.
PARTICIPANTS


180 patients with chronic LBP, previous disc herniation and Modic changes type I (n=118) or type II (n=62) were randomised to antibiotic treatment (n=89) or placebo-control (n=91).
INTERVENTIONS


Oral treatment with either 750 mg amoxicillin or placebo three times daily for 100 days.
MAIN OUTCOME MEASURES


Quality-adjusted life years (QALYs) by EuroQoL-5D over 12 months and costs for healthcare and productivity loss measured in Euro (€1=NOK 10), in the intention-to-treat population. Cost-utility was expressed in incremental cost-effectiveness ratio (ICER).
RESULTS


Mean (SD) total cost was €21 046 (20 105) in the amoxicillin group and €19 076 (19 356) in the placebo group, mean difference €1970 (95% CI; -3835 to 7774). Cost per QALY gained was €24 625. In those with type I Modic changes, the amoxicillin group had higher healthcare consumption than the placebo group, resulting in €39 425 per QALY gained. Given these ICERs and a willingness-to-pay threshold of €27 500 (NOK 275 000), the probability of amoxicillin being cost-effective was 51%. Even when the willingness-to-pay threshold increased to €55 000, the probability of amoxicillin being cost-effective was never higher than 53%.
CONCLUSIONS


Amoxicillin treatment showed no evidence of being cost-effective for people with chronic LBP and Modic changes during 1-year follow-up.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov NCT02323412.",2020,"In those with type I Modic changes, the amoxicillin group had higher healthcare consumption than the placebo group, resulting in €39 425 per QALY gained.","['patients with chronic low back pain and Modic changes (AIM) study', '180 patients with chronic LBP, previous disc herniation and Modic changes type I (n=118) or type II (n=62', 'Hospital outpatient clinics at six hospitals in Norway', 'patients with chronic low back pain (LBP) and type I or II Modic changes included in the Antibiotic treatment', 'patients with chronic low back pain and Modic changes']","['Amoxicillin', 'placebo-control (n=91', 'amoxicillin', 'amoxicillin or placebo', 'antibiotics', 'antibiotic treatment', 'placebo']","['Cost-utility', 'Quality-adjusted life years (QALYs) by EuroQoL-5D over 12 months and costs for healthcare and productivity loss', 'Mean (SD) total cost', 'probability of amoxicillin being cost-effective', 'incremental cost-effectiveness ratio (ICER', 'healthcare consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0029916', 'cui_str': 'Hospital Outpatient Clinics'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",180.0,0.51751,"In those with type I Modic changes, the amoxicillin group had higher healthcare consumption than the placebo group, resulting in €39 425 per QALY gained.","[{'ForeName': 'Margreth', 'Initials': 'M', 'LastName': 'Grotle', 'Affiliation': 'Department of Research and Innovation, Oslo University Hospital, Oslo, Norway mgrotle@oslomet.no.'}, {'ForeName': 'Lars Christian', 'Initials': 'LC', 'LastName': 'Bråten', 'Affiliation': 'FORMI, Oslo University Hospital Ullevaal, Oslo, OSLO, Norway.'}, {'ForeName': 'Jens Ivar', 'Initials': 'JI', 'LastName': 'Brox', 'Affiliation': 'Physical Medicine and rehabilitation, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ansgar', 'Initials': 'A', 'LastName': 'Espeland', 'Affiliation': 'Department of Radiology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Zinajda', 'Initials': 'Z', 'LastName': 'Zolic-Karlsson', 'Affiliation': 'Regional Research Support Services, Oslo University Hospital Ullevaal, Oslo, Norway.'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Munk Killingmo', 'Affiliation': 'Department of Physiotherapy, Oslo Metropolitan University Faculty of Health Sciences, Oslo, Oslo, Norway.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Tingulstad', 'Affiliation': 'Department of Physiotherapy, Oslo Metropolitan University Faculty of Health Sciences, Oslo, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Grøvle', 'Affiliation': 'Department of Rheumatology, Østfold Hospital Trust, Oslo, Oslo, Norway.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Froholdt', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Vestre Viken Hospital Trust, Drammen, Norway.'}, {'ForeName': 'Per Martin', 'Initials': 'PM', 'LastName': 'Kristoffersen', 'Affiliation': 'Department of Radiology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Wigemyr', 'Affiliation': 'FORMI, Oslo University Hospital Ullevaal, Oslo, OSLO, Norway.'}, {'ForeName': 'Maurits W', 'Initials': 'MW', 'LastName': 'van Tulder', 'Affiliation': 'Department of Health Sciences, VU University, Amsterdam, Netherlands.'}, {'ForeName': 'Kjersti', 'Initials': 'K', 'LastName': 'Storheim', 'Affiliation': 'Clinic for Surgery and Neurology, FORMI, Oslo, Norway.'}, {'ForeName': 'John-Anker', 'Initials': 'JA', 'LastName': 'Zwart', 'Affiliation': 'Department of Neurology and FORMI, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-035461']
2574,32546493,Role of the intelligent exercise rehabilitation management system on adherence of cardiac rehabilitation in patients with coronary heart disease: a randomised controlled crossover study protocol.,"INTRODUCTION


The benefits of cardiac rehabilitation (CR) on the reduction of cardiac and all-cause mortality are well documented. However, adherence remains suboptimal in China. It is clear that traditional CR does not meet the needs of many eligible patients and innovation is required to improve its application. Home-based CR (HBCR) is a cost-effective method that may be a valuable alternative for many individuals in China. In HBCR, it is often difficult to maintain an exercise intensity that is both effective and within safe limits, factors that are essential for patient safety. Mobile health interventions have the potential to overcome these obstacles and may be efficacious in improving adherence. The purpose of this study is to evaluate whether an Intelligent Exercise Rehabilitation Management System (IERMS)-based HBCR could improve adherence to CR and to assess the effects on exercise capacity, mental health, self-efficacy, quality of life and lifestyle-related risk factors.
METHODS AND ANALYSIS


We propose a single-blinded, two-arm, randomised controlled crossover study of 70 patients with coronary heart disease (CHD). Participants will be randomly assigned in a 1:1 ratio to one of the two groups. Patients in group 1 will receive the IERMS intervention together with usual care for the first 6 weeks and usual care for the last 6 weeks, while patients assigned to group 2 will receive usual care for the first 6 weeks and will use IERMS in the last 6 weeks. The primary outcome is adherence to the programme and secondary outcomes include exercise capacity, psychological well-being, quality of life, self-efficacy and lifestyle-related risk factors. All secondary outcomes will be measured at baseline, 6 weeks and 12 weeks.
ETHICS AND DISSEMINATION


This study has been approved by the Human Research Ethics Committee of the School of Nursing, Jilin University (HREC 2019120901). The results will be published in peer-reviewed journals and at conferences.
TRIAL REGISTRATION NUMBER


ChiCTR1900028182; Pre-results.",2020,"The primary outcome is adherence to the programme and secondary outcomes include exercise capacity, psychological well-being, quality of life, self-efficacy and lifestyle-related risk factors.","['70 patients with coronary heart disease (CHD', 'patients with coronary heart disease']","['Home-based CR (HBCR', 'IERMS intervention together with usual care for the first 6\u2009weeks and usual care for the last 6\u2009weeks, while patients assigned to group 2 will receive usual care for the first 6\u2009weeks and will use IERMS', 'Intelligent Exercise Rehabilitation Management System (IERMS)-based HBCR', 'intelligent exercise rehabilitation management system', 'cardiac rehabilitation (CR']","['exercise capacity, mental health, self-efficacy, quality of life and lifestyle-related risk factors', 'adherence to the programme and secondary outcomes include exercise capacity, psychological well-being, quality of life, self-efficacy and lifestyle-related risk factors', 'adherence of cardiac rehabilitation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}]",70.0,0.0831069,"The primary outcome is adherence to the programme and secondary outcomes include exercise capacity, psychological well-being, quality of life, self-efficacy and lifestyle-related risk factors.","[{'ForeName': 'Linqi', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Wenji', 'Initials': 'W', 'LastName': 'Xiong', 'Affiliation': 'The First Hospital of Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Jinwei', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Meidi', 'Initials': 'M', 'LastName': 'Shen', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Pang', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Ni', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Yuewei', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Lirong', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Lijing', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China lifeng2912@163.com.'}]",BMJ open,['10.1136/bmjopen-2019-036720']
2575,32546554,A randomized double-blind phase II study evaluating the role of maintenance therapy with cabozantinib in high-grade uterine sarcoma after stabilization or response to doxorubicin ± ifosfamide following surgery or in metastatic first line treatment (EORTC62113).,"BACKGROUND


Uterine sarcomas are a group of rare tumors that include different subtypes. Patients with histopathological high-grade diseases are at high-risk of recurrence or progression, and have a poor prognosis. We aim to explore the most appropriate management in patients with uterine high-grade sarcomas.
PRIMARY OBJECTIVE


To assess the efficacy of maintenance treatment with cabozantinib in patients with high-grade uterine sarcomas who achieved clinical benefit after standard chemotherapy.
STUDY HYPOTHESIS


Maintenance treatment with cabozantinib after standard chemotherapy given as an adjuvant treatment after curative surgery, or in locally advanced or metastatic disease, increases progression-free survival compared with placebo TRIAL DESIGN: This is a randomized double blinded phase II trial.
MAJOR INCLUSION/EXCLUSION CRITERIA


The study is enrolling adult patients with high-grade undifferentiated uterine sarcomas, high-grade endometrial stromal sarcomas, high-grade leiomyosarcoma, and high-grade adenosarcoma, FIGO (Federation International gynecologue Obstétricien) stage II/III to IV in stable disease or who achieved complete or partial response with doxorubicin ± ifosfamide, who are assigned 1:1 to 60 mg daily cabozantinib (experimental arm) or placebo (control arm), as maintenance therapy. Exclusion criteria include low-grade sarcoma.
PRIMARY ENDPOINT


Progression-free survival at 4 months.
SAMPLE SIZE


The study plans to enroll 90 patients to allow the randomization of 54 patients to detect an improvement in 4-month progression-free survival from 50% to 80% with 15% significance level and 85% power. Estimated dates for accrual completion: recruitment for the trial started in February 2015, and has currently enrolled 83 patients, of whom 35 patients have been randomized. The end of recruitment is anticipated for December 2020.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov, number NCT01979393.",2020,"Patients with histopathological high-grade diseases are at high-risk of recurrence or progression, and have a poor prognosis.","['patients with uterine high-grade sarcomas', 'enrolling adult patients with high-grade undifferentiated uterine sarcomas, high-grade endometrial stromal sarcomas, high-grade leiomyosarcoma, and high-grade adenosarcoma, FIGO (Federation International gynecologue Obstétricien) stage II/III to IV in stable disease or who achieved complete or partial response with', '83 patients, of whom 35 patients have been randomized', 'Patients with histopathological high-grade diseases', 'patients with high-grade uterine sarcomas who achieved clinical benefit after standard chemotherapy']","['cabozantinib after standard chemotherapy', 'cabozantinib (experimental arm) or placebo', 'cabozantinib', 'doxorubicin ± ifosfamide']","['Progression-free survival at 4 months', '4-month progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2239246', 'cui_str': 'Endometrial stromal sarcoma, high grade'}, {'cui': 'C0023269', 'cui_str': 'Leiomyosarcoma'}, {'cui': 'C0001442', 'cui_str': 'Adenosarcoma'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0338113', 'cui_str': 'Sarcoma of uterus'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0020823', 'cui_str': 'Ifosfamide'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",83.0,0.477096,"Patients with histopathological high-grade diseases are at high-risk of recurrence or progression, and have a poor prognosis.","[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Ray-Coquard', 'Affiliation': 'Centre Leon Berard, Lyon, Rhône-Alpes, France isabelle.ray-coquard@lyon.unicancer.fr.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hatcher', 'Affiliation': 'medical oncology, Cambridge University, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Bompas', 'Affiliation': 'Medical Oncology Department, ICO, Saint Herblain, Pays de la Loire, France.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Casado', 'Affiliation': 'Medical Oncology Department, Complutense University of Madrid, Madrid, Comunidad de Madrid, Spain.'}, {'ForeName': 'Annekke', 'Initials': 'A', 'LastName': 'Westermann', 'Affiliation': 'Medical Oncology Department, Academisch Medisch Centrum, Amsterdam, North Holland, The Netherlands.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Isambert', 'Affiliation': 'Medical Oncology Department, Centre Georges-François Leclerc, Dijon, Bourgogne-Franche-Comté, France.'}, {'ForeName': 'Paolo Giovanni', 'Initials': 'PG', 'LastName': 'Casali', 'Affiliation': 'Medical Oncology Department, IRCCS, Milano, Lombardia, Italy.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Pratap', 'Affiliation': 'Medical Oncology Department, Oxford University, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Stark', 'Affiliation': 'Medical Oncology Department, Leeds Teaching Hospitals NHS Trust, Leeds, Leeds, UK.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Valverde', 'Affiliation': ""Medical Oncology Department, Vall d'Hebron Hospital, Barcelona, Catalunya, Spain.""}, {'ForeName': 'Anjana', 'Initials': 'A', 'LastName': 'Anand', 'Affiliation': 'Medical Oncology Department, Nottingham Trent University, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Huizing', 'Affiliation': 'Medical Oncology Department, Universitair Ziekenhuis Antwerpen, Edegem, Antwerp, Belgium.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Floquet', 'Affiliation': 'Medical Oncology Department, Institut Bergonié, Bordeaux, Aquitaine, France.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Lindner', 'Affiliation': 'Medical Oncology Department, Ludwig-Maximilians-Universitat Munchen, Munchen, Bayern, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Hermes', 'Affiliation': 'Medical Oncology Department, Eberhard Karls Universitat Tubingen, Tubingen, Baden-Württemberg, Germany.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Seddon', 'Affiliation': 'Medical Oncology Department, University College London, London, London, UK.'}, {'ForeName': 'Corneel', 'Initials': 'C', 'LastName': 'Coens', 'Affiliation': 'Statistics and Quality of Life, EORTC, Brussels, Belgium.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Medical Oncology, Royal Marsden Hospital NHS Trust, London, London, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Reed', 'Affiliation': 'Medical Oncology, NHS Greater Glasgow and Clyde, Glasgow, Glasgow, UK.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-001519']
2576,32546645,Neutrophil-to-Lymphocyte Ratio as a Prognostic Factor of Disease-Free Survival in Post-Nephrectomy High-Risk Loco-Regional RCC: Analysis of the S-TRAC Trial.,"PURPOSE


In the S-TRAC trial, adjuvant sunitinib improved disease-free survival (DFS) compared with placebo in patients with loco-regional renal cell carcinoma (RCC) at high risk of recurrence. This post-hoc exploratory analysis investigated the neutrophil-to-lymphocyte ratio (NLR) for predictive and prognostic significance in the RCC adjuvant setting.
EXPERIMENTAL DESIGN


Kaplan-Meier estimates and Cox proportional analyses were performed on baseline NLR and change from baseline at week 4 to assess their association with DFS. Univariate P-values were two-sided and based on an unstratified log-rank test.
RESULTS


609/615 patients had baseline NLR values; 574 patients had baseline and week 4 values. Sunitinib-treated patients with baseline NLR <3 had longer DFS versus placebo (7.1 vs. 4.7; HR, 0.71; P = 0.02). For baseline NLR ≥3, DFS was similar regardless of treatment (sunitinib 6.8 vs. placebo not reached; HR, 1.03; P = 0.91). A ≥25% NLR decrease at week 4 was associated with longer DFS versus no change (6.8 vs. 5.3 years; HR, 0.71; P = 0.01). A greater proportion of sunitinib-treated patients had ≥25% NLR decrease at week 4 (71.2%) versus placebo (17.4%). Patients with ≥25% NLR decrease at week 4 received a higher median cumulative sunitinib dose (10,137.5 mg) versus no change (8,168.8 mg) or ≥25% increase (6,712.5 mg).
CONCLUSIONS


In the post-nephrectomy high-risk RCC patient cohort, low baseline NLR may help identify those most suitable for adjuvant sunitinib. A ≥25% NLR decrease at week 4 may be an early indicator of those most likely to tolerate treatment and derive DFS benefit.",2020,"For baseline NLR ≥3, DFS was similar regardless of treatment (sunitinib 6.8 vs. placebo not reached; HR, 1.03; P = 0.91).",['patients with loco-regional renal cell carcinoma (RCC) at high risk of recurrence'],['placebo'],"['neutrophil-to-lymphocyte ratio (NLR', 'disease-free survival (DFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",,0.276738,"For baseline NLR ≥3, DFS was similar regardless of treatment (sunitinib 6.8 vs. placebo not reached; HR, 1.03; P = 0.91).","[{'ForeName': 'Anup', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Urology, Self Employed anuppatel666@gmail.com.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Ravaud', 'Affiliation': 'Medical Oncology, Hopital Saint-Andre, University Hospital.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center.'}, {'ForeName': 'Allan J', 'Initials': 'AJ', 'LastName': 'Pantuck', 'Affiliation': 'Urology, UCLA School of Medicine.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Staehler', 'Affiliation': 'Urology, University of Munich.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Escudier', 'Affiliation': 'Gustave-Roussy.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Martini', 'Affiliation': 'Translational Oncology, Pfizer Inc.'}, {'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Lechuga', 'Affiliation': 'Clinical Research Oncology, Pfizer Italia S.r.l.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'Statistics, Pfizer Oncology.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'George', 'Affiliation': 'Departments of Medicine and Surgery, Duke University, Duke Cancer Institute.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0704']
2577,32546749,Compliance behaviour change in contact lens wearers: a randomised controlled trial.,"BACKGROUND


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


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


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


A no-water infographic on the contact lens case improved overall water-contact behaviours and reduced storage case endotoxin. Refining the messaging may be beneficial in future to improve other aspects of compliance.",2020,"After 6 weeks, the overall water exposure score and endotoxin levels reduced significantly in the test group compared with the control group (p < 0.05).","['200 daily lens wearers', '188 lens wearers completed both study visits; 128 females and 60 males; average age 29\u2009±\u200913 (range 18-78 years); 95 test and 93 control participants', 'contact lens wearers']","['storage case with a ""no-water"" sticker (test) or without a ""no-water"" sticker (control']","['self-administered lens hygiene questionnaire', 'overall water exposure score and endotoxin levels', 'overall water-contact behaviours and reduced storage case endotoxin', 'Compliance behaviour change', 'individual water-contact behaviours or overall storage case contamination']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0920138', 'cui_str': 'Contact lens wearer'}]","[{'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014264', 'cui_str': 'Bacterial endotoxin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",200.0,0.10914,"After 6 weeks, the overall water exposure score and endotoxin levels reduced significantly in the test group compared with the control group (p < 0.05).","[{'ForeName': 'Memoona', 'Initials': 'M', 'LastName': 'Arshad', 'Affiliation': 'School of Optometry and Vision Science, UNSW Sydney, Sydney, NSW, Australia. m.arshad@unsw.edu.au.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Carnt', 'Affiliation': 'School of Optometry and Vision Science, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Tan', 'Affiliation': 'School of Optometry and Vision Science, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Stapleton', 'Affiliation': 'School of Optometry and Vision Science, UNSW Sydney, Sydney, NSW, Australia.'}]","Eye (London, England)",['10.1038/s41433-020-1015-9']
2578,32546796,Physical deterioration and adaptive recovery in physically inactive breast cancer patients during adjuvant chemotherapy: a randomised controlled trial.,"Cardiorespiratory fitness is an independent risk factor for cardiovascular disease and shortened life expectancy in breast cancer survivors. This randomised controlled trial (n = 153) was designed for patients with a physically inactive lifestyle prediagnosis and concurrently referred to adjuvant chemotherapy. We compared two 12-week exercise interventions aimed at physiological and patient-reported outcomes (cardiorespiratory fitness, muscle strength, metabolic markers, physical activity, pain, fatigue), including a 39-week follow-up. A supervised hospital-based moderate to high intensity group exercise intervention was compared to an instructed home-based individual pedometer intervention. The two 12-week interventions included oncologists' recommendations and systematic health counselling. Outcomes were measured at baseline and week 6, 12 and 39. Primary outcome cardiorespiratory fitness declined significantly during chemotherapy and was restored in both interventions at follow-up. The interventions effectively engaged breast cancer patients in sustaining physical activities during and following adjuvant treatment. A composite metabolic score improved significantly. Positive cardiorespiratory fitness responders had improved clinical effects on fatigue, pain and dyspnoea versus negative responders. We conclude that a loss of cardiorespiratory fitness among physically inactive breast cancer patients may be restored by early initiated interventions and by adapting to physical activity recommendations, leading to a decreased cardiovascular risk profile in breast cancer survivors.",2020,"Positive cardiorespiratory fitness responders had improved clinical effects on fatigue, pain and dyspnoea versus negative responders.","['breast cancer survivors', 'physically inactive breast cancer patients']","['adjuvant chemotherapy', 'physically inactive lifestyle prediagnosis and concurrently referred to adjuvant chemotherapy', 'supervised hospital-based moderate to high intensity group exercise intervention was compared to an instructed home-based individual pedometer intervention', ""oncologists' recommendations and systematic health counselling""]","['composite metabolic score', 'outcomes (cardiorespiratory fitness, muscle strength, metabolic markers, physical activity, pain, fatigue', 'fatigue, pain and dyspnoea', 'Physical deterioration and adaptive recovery', 'cardiorespiratory fitness']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0509229,"Positive cardiorespiratory fitness responders had improved clinical effects on fatigue, pain and dyspnoea versus negative responders.","[{'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Møller', 'Affiliation': 'The University Hospitals Centre for Health Research (UCSF), Copenhagen University Hospital, Rigshospitalet, Department, 9701, Copenhagen, Denmark. tommoel@icloud.com.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Andersen', 'Affiliation': 'The University Hospitals Centre for Health Research (UCSF), Copenhagen University Hospital, Rigshospitalet, Department, 9701, Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lillelund', 'Affiliation': 'The University Hospitals Centre for Health Research (UCSF), Copenhagen University Hospital, Rigshospitalet, Department, 9701, Copenhagen, Denmark.'}, {'ForeName': 'Kira', 'Initials': 'K', 'LastName': 'Bloomquist', 'Affiliation': 'The University Hospitals Centre for Health Research (UCSF), Copenhagen University Hospital, Rigshospitalet, Department, 9701, Copenhagen, Denmark.'}, {'ForeName': 'Karl Bang', 'Initials': 'KB', 'LastName': 'Christensen', 'Affiliation': 'University of Copenhagen, Faculty of Health and Medical Sciences, Department of Public Health, Copenhagen, Denmark.'}, {'ForeName': 'Bent', 'Initials': 'B', 'LastName': 'Ejlertsen', 'Affiliation': 'Copenhagen University Hospital, Rigshospitalet, Department of Oncology, 7301, Copenhagen, Denmark.'}, {'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Tuxen', 'Affiliation': 'Copenhagen University Hospital, Rigshospitalet, Department of Oncology, 7301, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Oturai', 'Affiliation': 'Copenhagen University Hospital, Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine and PET, Copenhagen, Denmark.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Breitenstein', 'Affiliation': 'Copenhagen University Hospital, Rigshospitalet, Department of Oncology, 7301, Copenhagen, Denmark.'}, {'ForeName': 'Cecilie', 'Initials': 'C', 'LastName': 'Kolind', 'Affiliation': 'Copenhagen University Hospital, Herlev Hospital, Department of Oncology, Herlev, Denmark.'}, {'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Travis', 'Affiliation': 'Copenhagen University Hospital, Herlev Hospital, Department of Oncology, Herlev, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Bjerg', 'Affiliation': 'Copenhagen University Hospital, Rigshospitalet, Department of Oncology, 7301, Copenhagen, Denmark.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Rørth', 'Affiliation': 'Copenhagen University Hospital, Rigshospitalet, Department of Oncology, 7301, Copenhagen, Denmark.'}, {'ForeName': 'Lis', 'Initials': 'L', 'LastName': 'Adamsen', 'Affiliation': 'The University Hospitals Centre for Health Research (UCSF), Copenhagen University Hospital, Rigshospitalet, Department, 9701, Copenhagen, Denmark.'}]",Scientific reports,['10.1038/s41598-020-66513-9']
2579,32546834,A dynamic web-based decision aid to improve informed choice in organised breast cancer screening. A pragmatic randomised trial in Italy.,"BACKGROUND


Improving the quality of information and communication is a priority in organised breast cancer screening and an ethical duty. Programmes must offer the information each woman is looking for, promoting informed decision-making. This study aimed to develop and evaluate a web-based dynamic decision aid (DA).
METHODS


A pragmatic randomised trial carried out in six regional organised screening programmes recruited women at the first invitation receiving DA or a web-based standard brochure (SB). The primary outcome was informed choice measured on knowledge, attitudes, and intentions. Follow-up period: 7-10 days. Secondary outcomes included participation rate, satisfaction, decisional conflict, and acceptability of DA.
RESULTS


Two thousand one hundred and nineteen women were randomised and 1001 completed the study. Respectively, 43.9% and 36.9% in the DA and SB reached the informed choice. The DA gave a 13-point higher proportion of women aware about overdiagnosis compared to SB (38.3% versus 25.2%, p < 0.0001). The percentage of women attending screening was the same: 84% versus 83%. Decisional conflict was significantly lower in the DA group (14.4%) than in the SB group (19.3%).
CONCLUSION


DA increases informed choice. Complete information including the pros, cons, controversies, and overdiagnosis-overtreatment issues boost a woman's knowledge without reducing the rate of actual screening participation.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov number NCT03097653.",2020,"Decisional conflict was significantly lower in the DA group (14.4%) than in the SB group (19.3%).
","['Two thousand one hundred and nineteen women were randomised and 1001 completed the study', 'six regional organised screening programmes recruited women at the first invitation receiving DA or a web-based standard brochure (SB']",['web-based dynamic decision aid (DA'],"['percentage of women attending screening', 'participation rate, satisfaction, decisional conflict, and acceptability of DA', 'Decisional conflict', 'informed choice measured on knowledge, attitudes, and intentions']","[{'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C1300196', 'cui_str': 'Organized'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",2119.0,0.168763,"Decisional conflict was significantly lower in the DA group (14.4%) than in the SB group (19.3%).
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Roberto', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Colombo', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Candiani', 'Affiliation': 'Zadig, Agenzia di Editoria Scientifica, Milano, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Satolli', 'Affiliation': 'Zadig, Agenzia di Editoria Scientifica, Milano, Italy.'}, {'ForeName': 'Livia', 'Initials': 'L', 'LastName': 'Giordano', 'Affiliation': 'SSD Epidemiologia e Screening - CPO Piemonte - AOU Città della Salute e della Scienza, Torino, Italy.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Jaramillo', 'Affiliation': 'SSD Epidemiologia e Screening - CPO Piemonte - AOU Città della Salute e della Scienza, Torino, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Castagno', 'Affiliation': 'SSD Epidemiologia e Screening - CPO Piemonte - AOU Città della Salute e della Scienza, Torino, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Mantellini', 'Affiliation': 'SC Screening e Prevenzione Secondaria, Istituto per lo Studio, la Prevenzione e la Rete Oncologica - ISPRO, Firenze, Italy.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Falini', 'Affiliation': 'SC Screening e Prevenzione Secondaria, Istituto per lo Studio, la Prevenzione e la Rete Oncologica - ISPRO, Firenze, Italy.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Carnesciali', 'Affiliation': 'SC Screening e Prevenzione Secondaria, Istituto per lo Studio, la Prevenzione e la Rete Oncologica - ISPRO, Firenze, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Valenza', 'Affiliation': 'UO Centro Gestionale Screening, ASP di Palermo, Palermo, Italy.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Costa', 'Affiliation': 'U.O.S. Screening Mammografico, ASP di Palermo, Palermo, Italy.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Campari', 'Affiliation': 'S.S. Screening Oncologici - Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Caroli', 'Affiliation': 'S.S. Screening Oncologici - Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Roberto Cosimo', 'Initials': 'RC', 'LastName': 'Faggiano', 'Affiliation': 'S.S. Screening Oncologici - Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Orione', 'Affiliation': 'Centro Screening Cuneo, ASL CN1, Cuneo, Italy.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Belmessieri', 'Affiliation': 'Centro Screening Cuneo, ASL CN1, Cuneo, Italy.'}, {'ForeName': 'Vanda', 'Initials': 'V', 'LastName': 'Marchiò', 'Affiliation': 'Centro Screening Cuneo, ASL CN1, Cuneo, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Deandrea', 'Affiliation': 'UOC Medicina Preventiva delle Comunità - Screening, ATS della Città Metropolitana di Milano, Milano, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Silvestri', 'Affiliation': 'UOC Medicina Preventiva delle Comunità - Screening, ATS della Città Metropolitana di Milano, Milano, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Luciano', 'Affiliation': 'UOC Medicina Preventiva delle Comunità - Screening, ATS della Città Metropolitana di Milano, Milano, Italy.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Paci', 'Affiliation': 'Lega Italiana per la Lotta contro i Tumori, Sezione Firenze, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Mosconi', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy. paola.mosconi@marionegri.it.'}]",British journal of cancer,['10.1038/s41416-020-0935-2']
2580,32550021,Expiratory Flow Limitation at Different Exercise Intensities in Coronary Artery Disease.,"Introduction


Expiratory flow limitation (EFL) during moderate intensity exercise is present in patients with myocardial infarction (MI), whereas in healthy subjects it occurs only at a high intensity. However, it is unclear whether this limitation already manifests in those with stable coronary artery disease (CAD) (without MI).
Materials and Methods


Forty-one men aged 40-65 years were allocated into (1) recent MI (RMI) group ( n  = 8), (2) late MI (LMI) group ( n  = 12), (3) stable CAD group ( n  = 9), and (4) healthy control group (CG) ( n  = 12). All participants underwent two cardiopulmonary exercise tests at a constant workload (moderate and high intensity), and EFL was evaluated at the end of each exercise workload.
Results


During moderate intensity exercise, the RMI and LMI groups presented with a significantly higher number of participants with EFL compared to the CG ( p  < 0.05), while no significant difference was observed among groups at high intensity exercise ( p  > 0.05). Moreover, EFL was only present in MI groups during moderate intensity exercise, whereas at high intensity all groups presented EFL. Regarding the degree of EFL, the RMI and LMI groups showed significantly higher values at moderate intensity exercise in relation to the CG. At high intensity exercise, significantly higher values for the degree of EFL were observed only in the LMI group.
Conclusion


The ventilatory limitation at moderate intensity exercise may be linked to the pulmonary consequences of the MI, even subjects with preserved cardiac and pulmonary function at rest, and not to CAD per se.",2020,"During moderate intensity exercise, the RMI and LMI groups presented with a significantly higher number of participants with EFL compared to the CG ( p  < 0.05), while no significant difference was observed among groups at high intensity exercise ( p  > 0.05).","['Coronary Artery Disease', 'patients with myocardial infarction (MI', 'Materials and Methods\n\n\nForty-one men aged 40-65 years']","['healthy control group (CG', 'EFL', 'Introduction\n\n\nExpiratory flow limitation (EFL']","['degree of EFL', 'Expiratory Flow Limitation']","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]",41.0,0.0160216,"During moderate intensity exercise, the RMI and LMI groups presented with a significantly higher number of participants with EFL compared to the CG ( p  < 0.05), while no significant difference was observed among groups at high intensity exercise ( p  > 0.05).","[{'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'Castello-Simões', 'Affiliation': 'Department of Physical Therapy, Cardiovascular Physiotherapy Laboratory, Nucleus of Research in Physical Exercise, Federal University of São Carlos, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Marlus', 'Initials': 'M', 'LastName': 'Karsten', 'Affiliation': 'Department of Physical Therapy, Cardiovascular Physiotherapy Laboratory, Nucleus of Research in Physical Exercise, Federal University of São Carlos, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Vinicius', 'Initials': 'V', 'LastName': 'Minatel', 'Affiliation': 'Department of Physical Therapy, Cardiovascular Physiotherapy Laboratory, Nucleus of Research in Physical Exercise, Federal University of São Carlos, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Rodrigo Polaquini', 'Initials': 'RP', 'LastName': 'Simões', 'Affiliation': 'Department of Physical Therapy, Cardiovascular Physiotherapy Laboratory, Nucleus of Research in Physical Exercise, Federal University of São Carlos, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Silva', 'Affiliation': 'Department of Physical Therapy, Cardiovascular Physiotherapy Laboratory, Nucleus of Research in Physical Exercise, Federal University of São Carlos, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Nayara Yamada', 'Initials': 'NY', 'LastName': 'Tamburús', 'Affiliation': 'Department of Physical Therapy, Cardiovascular Physiotherapy Laboratory, Nucleus of Research in Physical Exercise, Federal University of São Carlos, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Arena', 'Affiliation': 'Department of Physical Therapy and Integrative Physiology Laboratory, College of Applied Health Sciences, University of Illinois Chicago, Chicago, IL, USA.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Borghi-Silva', 'Affiliation': 'Department of Physical Therapy, Cardiovascular Physiotherapy Laboratory, Nucleus of Research in Physical Exercise, Federal University of São Carlos, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Aparecida Maria', 'Initials': 'AM', 'LastName': 'Catai', 'Affiliation': 'Department of Physical Therapy, Cardiovascular Physiotherapy Laboratory, Nucleus of Research in Physical Exercise, Federal University of São Carlos, São Carlos, São Paulo, Brazil.'}]",Cardiology research and practice,['10.1155/2020/4629548']
2581,32550156,"Effects of probiotic, cinnamon, and synbiotic supplementation on glycemic control and antioxidant status in people with type 2 diabetes; a randomized, double-blind, placebo-controlled study.","Purpose


The aim of this study was to investigate the effect of probiotic bacteria of  Lactobacillus acidophilus , cinnamon powder and their combinations on the glycemic and antioxidant indices in patients with type 2 diabetes.
Methods


A total of 136 patients randomized with type 2 diabetes entered the study and were randomly divided into four groups who were matched for age and gender. Thereafter, alongside their routine pharmacotherapy, each group followed one of the following diets: Group A:  Lactobacillus acidophilus  10 8  cfu and 0.5 g of powdered cinnamon (synbiotic). Group B:  Lactobacillus acidophilus  (probiotic), Group C: powdered cinnamon. Group D: rice flour powder as placebo. At the beginning and end of the intervention, fasting blood sugar (FBS), HbA1c, advance glycation end products (AGE), aspartate aminotransferase (AST), alanine aminotransferase (ALT) and antioxidant enzymes of superoxide dismutase (SOD), glutathione peroxidase (GPx) and catalase (CAT) were measured.
Results


Following 3 months of treatment, the mean FBS level was decreased significantly in probiotic, cinnamon, and synbiotic supplementation groups compared with control ( P  < 0.01). FBS levels in probiotic, cinnamon, and synbiotic groups were significantly decreased compared with the control group ( P  = 0.001,  P  = 0.063 and  P  = 0.001, respectively). The mean HbA1C in probiotic, cinnamon, and synbiotic groups were also decreased ( P =  0.001,  P  = 0.001 and  P  = 0.04, respectively). The mean AGE in synbiotic group was significantly decreased ( P  = 0.037). Probiotic, cinnamon and synbiotic all could improve antioxidant enzyme activity modestly. However, the most significant effect was seen in probiotic group.
Conclusions


According to the current results, the use of probiotic supplements (individually or in combination with cinnamon) leads to a reduction in blood glucose and an increase in antioxidant enzymes in people with type 2 diabetes.",2020,The mean AGE in synbiotic group was significantly decreased ( P  = 0.037).,"['people with type 2 diabetes', '136 patients randomized with type 2 diabetes entered the study and were randomly divided into four groups who were matched for age and gender', 'patients with type 2 diabetes']","['probiotic bacteria of  Lactobacillus acidophilus , cinnamon powder and their combinations', 'rice flour powder as placebo', 'Lactobacillus acidophilus  (probiotic), Group C: powdered cinnamon', 'Probiotic, cinnamon and synbiotic', 'Lactobacillus acidophilus  10 8 \xa0cfu and 0.5\xa0g of powdered cinnamon (synbiotic', 'probiotic, cinnamon, and synbiotic supplementation', 'probiotic supplements (individually or in combination with cinnamon', 'placebo']","['mean FBS level', 'glycemic and antioxidant indices', 'blood glucose', 'glycemic control and antioxidant status', 'FBS levels', 'antioxidant enzymes', 'mean AGE', 'antioxidant enzyme activity', 'fasting blood sugar (FBS), HbA1c, advance glycation end products (AGE), aspartate aminotransferase (AST), alanine aminotransferase (ALT) and antioxidant enzymes of superoxide dismutase (SOD), glutathione peroxidase (GPx) and catalase (CAT']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0008802', 'cui_str': 'Cinnamomum verum'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3495427', 'cui_str': 'Fanconi-Bickel Syndrome'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0243102', 'cui_str': 'enzyme activity'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}]",136.0,0.0478112,The mean AGE in synbiotic group was significantly decreased ( P  = 0.037).,"[{'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Mirmiranpour', 'Affiliation': 'Endocrinology and Metabolism Research Center (EMRC) Vali-Asr Hospital, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hasan Fallah', 'Initials': 'HF', 'LastName': 'Huseini', 'Affiliation': 'Medicinal Plants Research Center, Institute of Medicinal Plants, ACECR, Karaj, Iran.'}, {'ForeName': 'Hoda', 'Initials': 'H', 'LastName': 'Derakhshanian', 'Affiliation': 'Dietary Supplements and Probiotic Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Khodaii', 'Affiliation': 'Dietary Supplements and Probiotic Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Tavakoli-Far', 'Affiliation': 'Dietary Supplements and Probiotic Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}]",Journal of diabetes and metabolic disorders,['10.1007/s40200-019-00474-3']
2582,32550157,"Whole body vibration showed beneficial effect on pain, balance measures and quality of life in painful diabetic peripheral neuropathy: a randomized controlled trial.","Purpose


The aim of the study was to determine the efficacy of whole body vibration (WBV) therapy on pain, neuropathy disability score, balance, proprioception and quality of life (QOL) in patients with painful diabetic peripheral neuropathy (PDPN).
Methods


Twenty-six (16 males and 10 females) patients with PDPN were selected on the basis of inclusion and exclusion criteria. Subjects were randomly allocated to an experimental group ( n  = 13, age = 60.69 ± 5.08) and a control group (n = 13, age = 59.54 ± 4.25). The experimental group was given WBV therapy for six weeks (3 days/week) in addition to standard medical care, dietary advice and lifestyle modifications. Control group was provided only standard medical care, dietary advice and lifestyle modifications. Outcome measures included numeric pain rating scale (NPRS), Leeds assessment of neuropathic symptoms and signs (LANSS), vibration perception threshold (VPT), neuropathy disability score (NDS), proprioception, single-leg stance test (SLST), timed up and go test  ( TUGT) and short form 36 questionnaire (SF-36).
Results


NPRS, LANSS, NDS, SLST and TUGT showed significant time effect ( p  ≤ 0.022) and time×group interaction ( p  ≤ 0.007), whereas group effect was found to be significant only in LANSS ( p  = 0.001). VPT showed significant group effect ( p  ≤ 0.045) and time×group interaction ( p  ≤ 0.007) at great toe, metatarsal head and total average score. SF-36 was found to be significant time effect ( p  ≤ 0.024) in all domains except limitations due to physical health ( p  = 0.461). SF-36 average score was found be significant for group effect ( p  = 0.002) and time×group interaction ( p  < 0.001).
Conclusion


WBV improves sensory sensations like pain and vibration perception, neuropathy disability score, balance measures and health-related QOL in PDPN.",2020,SF-36 was found to be significant time effect ( p  ≤ 0.024) in all domains except limitations due to physical health ( p  = 0.461).,"['painful diabetic peripheral neuropathy', 'patients with painful diabetic peripheral neuropathy (PDPN', 'Methods\n\n\nTwenty-six (16 males and 10 females) patients with PDPN were selected on the basis of inclusion and exclusion criteria']","['standard medical care, dietary advice and lifestyle modifications', 'VPT', 'whole body vibration (WBV) therapy']","['pain, neuropathy disability score, balance, proprioception and quality of life (QOL', 'numeric pain rating scale (NPRS), Leeds assessment of neuropathic symptoms and signs (LANSS), vibration perception threshold (VPT), neuropathy disability score (NDS), proprioception, single-leg stance test (SLST), timed up and go test  ( TUGT) and short form 36 questionnaire (SF-36', 'Results\n\n\nNPRS, LANSS, NDS, SLST and TUGT', 'time effect', 'sensory sensations like pain and vibration perception, neuropathy disability score, balance measures and health-related QOL in PDPN', 'pain, balance measures and quality of life', 'SF-36 average score', 'time×group interaction', 'LANSS']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0740447', 'cui_str': 'Diabetic peripheral neuropathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0740447', 'cui_str': 'Diabetic peripheral neuropathy'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}]",,0.0331054,SF-36 was found to be significant time effect ( p  ≤ 0.024) in all domains except limitations due to physical health ( p  = 0.461).,"[{'ForeName': 'Albina', 'Initials': 'A', 'LastName': 'Jamal', 'Affiliation': 'Center for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia (A Central University), New Delhi, India.'}, {'ForeName': 'Irshad', 'Initials': 'I', 'LastName': 'Ahmad', 'Affiliation': 'Center for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia (A Central University), New Delhi, India.'}, {'ForeName': 'Nisar', 'Initials': 'N', 'LastName': 'Ahamed', 'Affiliation': 'Center for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia (A Central University), New Delhi, India.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Azharuddin', 'Affiliation': 'Center for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia (A Central University), New Delhi, India.'}, {'ForeName': 'Farhan', 'Initials': 'F', 'LastName': 'Alam', 'Affiliation': 'Center for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia (A Central University), New Delhi, India.'}, {'ForeName': 'M Ejaz', 'Initials': 'ME', 'LastName': 'Hussain', 'Affiliation': 'Center for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia (A Central University), New Delhi, India.'}]",Journal of diabetes and metabolic disorders,['10.1007/s40200-019-00476-1']
2583,32550188,Adverse effects of honey on low-density lipoprotein cholesterol and adiponectin concentrations in patients with type 2 diabetes: a randomized controlled cross-over trial.,"Background


Due to phenolic and fructose content, honey may be a suitable sweetener for patients with type 2 diabetes. However, its effect on oxidative and inflammatory status of diabetes patients is not clear. We aimed to investigate the effect of natural honey on some of oxidative, inflammatory, and anti-inflammatory markers of patients with type 2 diabetes.
Methods


In a randomized controlled cross-over trial, 43 patients with type 2 diabetes were allocated to isocaloric conditions with either dietary recommendations (control) or natural honey (50 g/day) plus dietary recommendations (honey) for 8 weeks with one month washout period in between. Serum lipids, malondialdehyde (MDA), total antioxidant capacity (TAC), high-sensitivity C-reactive protein (hs-CRP), and adiponectin levels were measured at baseline and the end of each sequence.
Results


Malondialdehyde (10.9%, P = 0.01), hs-C reactive protein (10.6%, P = 0.003), and adiponectin (7.1%, P < 0.001) concentrations significantly decreased in honey condition. Low-density lipoprotein cholesterol (LDL-C) (16.8%, P < 0.001) significantly decreased in control and high-density lipoprotein cholesterol (HDL-C) significantly increased in both conditions. Between-group differences were only statistically significant for adiponectin (P = 0.005) and LDL-C (P = 0.005).
Conclusions


Consumption of 50 g/day honey had adverse effects on LDL-C and adiponectin levels in patients with type 2 diabetes. Honey may need to be consumed with caution in type 2 diabetes patients.",2020,"Results


Malondialdehyde (10.9%, P = 0.01), hs-C reactive protein (10.6%, P = 0.003), and adiponectin (7.1%, P < 0.001) concentrations significantly decreased in honey condition.","['type 2 diabetes patients', 'diabetes patients', '43 patients with type 2 diabetes', 'patients with type 2 diabetes']",['isocaloric conditions with either dietary recommendations (control) or natural honey (50 g/day) plus dietary recommendations (honey'],"['control and high-density lipoprotein cholesterol (HDL-C', 'adiponectin', 'Serum lipids, malondialdehyde (MDA), total antioxidant capacity (TAC), high-sensitivity C-reactive protein (hs-CRP), and adiponectin levels', 'hs-C reactive protein', 'Low-density lipoprotein cholesterol (LDL-C', 'LDL-C', 'low-density lipoprotein cholesterol and adiponectin concentrations', 'LDL-C and adiponectin levels']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0019906', 'cui_str': 'Honey'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",43.0,0.134278,"Results


Malondialdehyde (10.9%, P = 0.01), hs-C reactive protein (10.6%, P = 0.003), and adiponectin (7.1%, P < 0.001) concentrations significantly decreased in honey condition.","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Sadeghi', 'Affiliation': 'School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Razi Blvd, Shiraz, Iran.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Akhlaghi', 'Affiliation': 'School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Razi Blvd, Shiraz, Iran.'}, {'ForeName': 'Saedeh', 'Initials': 'S', 'LastName': 'Salehi', 'Affiliation': 'School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Razi Blvd, Shiraz, Iran.'}]",Journal of diabetes and metabolic disorders,['10.1007/s40200-020-00518-z']
2584,32550193,Adjusted tight control blood glucose management in diabetic patients undergoing on pump coronary artery bypass graft. A randomized clinical trial.,"Background


Many of the patients who are undergoing Coronary Artery Bypass Graft have diabetes mellitus or metabolic syndrome and are at risk for hyperglycemia events.
Objective


The present study aimed to compare conventional glucose control with adjusted tight control in patients undergoing on-pump CABG.
Methods


This double -blind randomized clinical trial study was conducted in Shiraz, Iran, from September 2017-March 2018. Two consecutive groups of 75 patients undergoing elective on- pump coronary artery bypass graft surgery.
Intervention


The patients were divided into adjusted tight control of the blood glucose between 100 and 120 mg/dl and conventional method that the blood glucose maintained ≤200 mg/dl.
Primary outcomes were


mortality, sternal wound infection, cardiac arrhythmia, cerebrovascular attack, and acute renal failure.
Secondary outcomes included


duration of mechanical ventilation and length of ICU staying. The same main outcomes were evaluated after one month.
Statistical analysis


The data were analyzed using SPSS version 20(SPSS, Chicago, IL). Group comparisons were performed using t-tests and Chi-square tests. Repeated measurement test was used for comparing blood glucose in two groups. Mann Whitney U test was compared duration of the mechanical ventilation and length of ICU staying. Statistical significance was defined as a  p  value <0.05.
Results


There were no significant differences between main and secondary outcomes. About late outcomes, sternal wound infection was in the control group (7 patients) more than intervention (1 patient) ( P  < 0.05). No differences between other complications in both groups were observed. The occurrence of hypoglycemia was low in both groups. Hypokalemia was significantly higher in the intervention than in control ( P  < 0.001).
Conclusions


The findings showed using adjusted tight glycemic control to a level that is nearby to normal values during cardiac surgery may reduce episodes of hypoglycemia and thus reduces its side effects. As well as reduce hyperglycemic complications such as sternal wound infection.
Trial registration number


IRCT2013041713052N1). 2013-07-09.",2020,"Hypokalemia was significantly higher in the intervention than in control ( P  < 0.001).
","['Shiraz, Iran, from September 2017-March 2018', 'patients undergoing on-pump CABG', 'diabetic patients undergoing on pump coronary artery bypass graft', 'patients who are undergoing Coronary Artery Bypass Graft have diabetes mellitus or metabolic syndrome', '75 patients undergoing']","['elective on- pump coronary artery bypass graft surgery', 'conventional glucose control with adjusted tight control', 'blood glucose between 100 and 120\xa0mg/dl and conventional method that the blood glucose maintained ≤200\xa0mg/dl']","['Hypokalemia', 'hyperglycemic complications', 'sternal wound infection', 'duration of mechanical ventilation and length of ICU staying', 'mortality, sternal wound infection, cardiac arrhythmia, cerebrovascular attack, and acute renal failure', 'occurrence of hypoglycemia']","[{'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}]",75.0,0.0927746,"Hypokalemia was significantly higher in the intervention than in control ( P  < 0.001).
","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Javaherforoosh Zadeh', 'Affiliation': 'Department of Anesthesia, Ahvaz Anesthesiology and Pain Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Azemati', 'Affiliation': 'Anesthesiology and Critical Care Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Journal of diabetes and metabolic disorders,['10.1007/s40200-020-00494-4']
2585,32550196,Comparison home care service  versus  hospital-based care  in patients with diabetic foot  ulcer : an  economic evaluation study.,"Introduction


Providing health care to patients at home could be causing the mortality and readmission rates reduction in addition to satisfaction of both patients and health care providers increase. The aim of this study was to assess the cost-effectiveness of home care service compared to hospital based care in patients with diabetic foot ulcer.
Methods


An economic evaluation study and a trial study were simultaneously conducted in Iran. In trial phase, patients with diabetic foot ulcer were randomly assigned to the home care or hospital care. The Cost and Quality of life data were determined as measures of the study. Incremental cost-effectiveness ratio was calculated for comparative purposes. The model consisted of five stages of the disease. The Tree Age Pro 2009 and R software's were used for data analysis.
Results


120 patients were enrolled in our trial; among which 30 patients were in home care service group and 90 patients in hospital based care group. The rate of ulcer size reduction in hospital based care was significant ( P  value = 0.003) in comparison with home care service. The total cost of the home care and hospital strategies were 1720.4 US$, 3940.3 US$ and the total effectiveness were 0.31 and 0.29, respectively. The incremental cost-effectiveness ratio (ICER) was 117,300 US$ per quality-adjusted life year for home care intervention compared to hospital based care. Based on ICER plane home care treatment will be placed on the southeastern quadrant of the Cost-Effectiveness Plane, and is suggested as a more dominant treatment alternative.
Conclusions


Regarding current evidence, home care strategy for patients suffering diabetic foot ulcer enjoys more cost effectiveness compared to hospital care. It is suggested that healthcare policy makers determine the tariff for health care services for disease groups according to the activity based costing approach.",2020,The rate of ulcer size reduction in hospital based care was significant ( P  value = 0.003) in comparison with home care service.,"['Iran', 'patients with diabetic foot ulcer', 'patients suffering diabetic foot ulcer enjoys', '120 patients were enrolled in our trial; among which 30 patients were in home care service group and 90 patients in hospital based care group', 'patients with diabetic foot  ulcer ']","['home care service', 'hospital based care', 'home care or hospital care', 'Comparison home care service  versus  hospital-based care']","['total cost of the home care and hospital strategies', 'Cost and Quality of life data', 'rate of ulcer size reduction', 'Incremental cost-effectiveness ratio', 'cost-effectiveness', 'incremental cost-effectiveness ratio (ICER']","[{'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0019855', 'cui_str': 'Services, Home Care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0019855', 'cui_str': 'Services, Home Care'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",30.0,0.01642,The rate of ulcer size reduction in hospital based care was significant ( P  value = 0.003) in comparison with home care service.,"[{'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Jafary', 'Affiliation': 'Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Amini', 'Affiliation': 'Diabetes Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sanjari', 'Affiliation': 'Diabetes Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Aalaa', 'Affiliation': 'Department of Medical Education, Center for Educational Research in Medical Sciences (CERMS), School of Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Goudarzi', 'Affiliation': 'Department of Pharmacoeconomics and pharmaceutical administration, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zh', 'Initials': 'Z', 'LastName': 'Najafpour', 'Affiliation': 'Department of Health care Management, School of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Mohajeri Tehrani', 'Affiliation': 'Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.'}]",Journal of diabetes and metabolic disorders,['10.1007/s40200-020-00527-y']
2586,32550224,"Variability in airway inflammation, symptoms, lung function and reliever use in asthma: anti-inflammatory reliever hypothesis and STIFLE study design.","Asthma is a chronic inflammatory airway disease. Increase in airway inflammation is hypothesised to contribute to worsening of asthma symptoms and deterioration in lung function, resulting in the use of reliever medication. Short-acting β 2 -agonists only treat the symptoms, whereas an anti-inflammatory reliever is believed to treat both symptoms and the underlying inflammation, thereby arresting the progression to an exacerbation. As-needed budesonide/formoterol as an anti-inflammatory reliever reduces the risk of severe exacerbations. However, supporting mechanistic evidence has not yet been described, specifically the temporal dynamics of parameters including airway inflammation, over time and during asthma worsening. The STIFLE study aims to characterise daily variability in airway inflammation, symptoms, lung function and reliever use in people with asthma. This phase IV, open-label, parallel-group, multicentre, exploratory study will enrol 60-80 adult patients with asthma receiving low- or medium-dose inhaled corticosteroids/long-acting β 2 -agonists (EudraCT identifier number 2018-003467-64). Participants will be randomised 1:1 to either as-needed budesonide/formoterol dry-powder inhaler or salbutamol reliever for 24 weeks, in addition to their maintenance therapy. Daily data will be captured for fractional exhaled nitric oxide, spirometry, asthma symptoms and medication use using devices connected to a smartphone  via  the STIFLE application. STIFLE will thereby enable not only characterisation of the variability of airway inflammation and clinical outcomes in relation to asthma worsening, but also elucidate the effect of as-needed budesonide/formoterol on airway inflammation against a background of daily maintenance therapy.",2020,"STIFLE will thereby enable not only characterisation of the variability of airway inflammation and clinical outcomes in relation to asthma worsening, but also elucidate the effect of as-needed budesonide/formoterol on airway inflammation against a background of daily maintenance therapy.","['80 adult patients with asthma receiving low- or medium-dose inhaled corticosteroids/long-acting β 2 -agonists (EudraCT identifier number 2018-003467-64', 'people with asthma']","['budesonide/formoterol', 'budesonide/formoterol dry-powder inhaler or salbutamol reliever']","['airway inflammation, symptoms, lung function and reliever use', 'Variability in airway inflammation, symptoms, lung function and reliever use']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}, {'cui': 'C1967611', 'cui_str': 'Dry powder inhaler'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}]","[{'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",80.0,0.0772454,"STIFLE will thereby enable not only characterisation of the variability of airway inflammation and clinical outcomes in relation to asthma worsening, but also elucidate the effect of as-needed budesonide/formoterol on airway inflammation against a background of daily maintenance therapy.","[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Harrison', 'Affiliation': 'Nottingham NIHR Biomedical Research Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Pavord', 'Affiliation': 'Respiratory Medicine Unit and Oxford Respiratory NIHR BRC, Nuffield Dept of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Chalmers', 'Affiliation': 'Scottish Centre for Respiratory Research, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Whelan', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Fagerås', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Rutgersson', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Belton', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Shahid', 'Initials': 'S', 'LastName': 'Siddiqui', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Gustafson', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}]",ERJ open research,['10.1183/23120541.00333-2019']
2587,32548333,Rice bran arabinoxylan compound and quality of life of cancer patients (RBAC-QoL): Study protocol for a randomized pilot feasibility trial.,"Introduction


Rice bran arabinoxylan compound (RBAC) is a nutraceutical for enhancing a depleted immune system during and after cancer treatment. This pilot feasibility trial aims to evaluate the effects of RBAC on cancer patients' quality of life during active treatment, compared to placebo, using a validated questionnaire. Other outcome measures include changes in inflammatory and nutritional status, cytokine profile, and gut microbiota.
Methods/Design


The study will recruit 50 participants from a regional cancer center in Australia. Patients aged 18-70, diagnosed with solid organ cancers stage II and above, and currently undergoing active systemic therapies, are eligible. Random allocation of participants into two groups is stratified based on metastatic status and treatment type. The dosage is either 3 g/day of RBAC or placebo in identical packaging. The participants, study coordinator, and treating oncologists are blinded to the interventions. Data collections are at baseline and at four follow-up sessions, which are six weeks apart (24 weeks). Statistical analysis will involve a protected p-value with multiple dependent values and analyzed by ANOVA with repeated measures on the occasion of testing and with both a full Bonferroni or Sidak corrections applied to protect against Type I errors. Any observed significance warrants further analysis with pairwise comparisons. Analysis of covariance will also be performed to assess any influence of the demographic data, cancer diagnosis, as well as changes in physical activity, dietary habits, and complementary medicine usage. Comparisons of gut microbiota will be based on the analysis of the fecal microbiome using 16S ribosomal ribonucleic acid amplicon sequencing. The proposed research timeline is from October 2018 to May 2022.
Trial registration


ANZCTR. Reg No: ACTRN12619000562178p.",2020,"This pilot feasibility trial aims to evaluate the effects of RBAC on cancer patients' quality of life during active treatment, compared to placebo, using a validated questionnaire.","['50 participants from a regional cancer center in Australia', 'Patients aged 18-70, diagnosed with solid organ cancers stage II and above, and currently undergoing active systemic therapies, are eligible', 'cancer patients (RBAC-QoL']","['Reg', 'RBAC', 'Rice bran arabinoxylan', 'Introduction\n\n\nRice bran arabinoxylan compound (RBAC', 'RBAC or placebo', 'placebo']","['changes in inflammatory and nutritional status, cytokine profile, and gut microbiota', ""cancer patients' quality of life""]","[{'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0440790', 'cui_str': 'Solid organ'}, {'cui': 'C0027646', 'cui_str': 'Cancer staging'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0982374', 'cui_str': 'RICE BRAN'}, {'cui': 'C0250438', 'cui_str': 'arabinoxylan'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]","[{'cui': 'C0208940', 'cui_str': 'REG1A protein, human'}, {'cui': 'C0982374', 'cui_str': 'RICE BRAN'}, {'cui': 'C0250438', 'cui_str': 'arabinoxylan'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",50.0,0.183051,"This pilot feasibility trial aims to evaluate the effects of RBAC on cancer patients' quality of life during active treatment, compared to placebo, using a validated questionnaire.","[{'ForeName': 'Soo Liang', 'Initials': 'SL', 'LastName': 'Ooi', 'Affiliation': 'School of Biomedical Sciences, Charles Sturt University, Bathurst, NSW, 2795, Australia.'}, {'ForeName': 'Sok Cheon', 'Initials': 'SC', 'LastName': 'Pak', 'Affiliation': 'School of Biomedical Sciences, Charles Sturt University, Bathurst, NSW, 2795, Australia.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Micalos', 'Affiliation': 'School of Biomedical Sciences, Charles Sturt University, Bathurst, NSW, 2795, Australia.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Schupfer', 'Affiliation': 'School of Biomedical Sciences, Charles Sturt University, Bathurst, NSW, 2795, Australia.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Zielinski', 'Affiliation': 'Central West Cancer Centre, Orange Health Service, Orange, NSW, 2800, Australia.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jeffries', 'Affiliation': 'School of Science, Western Sydney University, Penrith, NSW, 2751, Australia.'}, {'ForeName': 'Garth', 'Initials': 'G', 'LastName': 'Harris', 'Affiliation': 'BioMedica Nutraceuticals Pty Ltd, Alexandria, NSW, 2015, Australia.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Golombick', 'Affiliation': 'St George Hospital, Kogarah, NSW, 2217, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'McKinnon', 'Affiliation': 'Edith Cowan Institute for Education Research, Edith Cowan University, Joondalup, WA, 6027, Australia.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100580']
2588,32548341,"Brief Intervention for Tobacco when Diagnosed with Oral Cancer (BITDOC): Study protocol of a randomized clinical trial studying efficacy of brief tobacco cessation intervention, Chhattisgarh, India.","INTRODUCTION


Tobacco use is a major causative factor for cancer. Cessation programs along with diagnosis of cancer as a motivating factor may improve quitting rates in patients. This is a protocol of a study that aims to assess the efficacy of brief tobacco cessation intervention (compared to treatment as usual, TAU) on pattern and attitudes towards tobacco chewing in newly diagnosed head and neck cancer patients and their relatives.
METHODS


The proposed study will be conducted in two phases. Phase 1 will include 105 dyads of patients and relatives and shall assess patterns (amount, frequency, duration of use and dependence etc.) and knowledge and attitudes (quitting, continued use, health-behavioural modifications, long-term effects on treatment etc.) towards tobacco chewing in newly diagnosed head and neck cancer patients using smokeless tobacco and their relatives. Sample will be recruited from outpatients attending the ear, nose, throat and head and neck surgery department of a tertiary health care institute. Phase 2 will be a randomized trial that will compare the efficacy of the 'Brief Intervention for Tobacco when Diagnosed with Oral Cancer' (BITDOC) and TAU, and will include 27 dyads in each of the two groups. Intervention will be delivered in three sessions, based on the principles of motivational interviewing and the 3As model.
CONCLUSIONS


This study will help in the evaluation of the attitude towards smokeless tobacco (SLT) in a population that has faced the adverse consequences from its use and changes brought by a diagnosis of HNC. It will also help in developing a cost-effective model for promotion of smoking cessation.",2020,This study will help in the evaluation of the attitude towards smokeless tobacco (SLT) in a population that has faced the adverse consequences from its use and changes brought by a diagnosis of HNC.,"['newly diagnosed head and neck cancer patients using smokeless tobacco and their relatives', 'Diagnosed with Oral Cancer (BITDOC', 'outpatients attending the ear, nose, throat and head and neck surgery department of a tertiary health care institute', 'patients', 'newly diagnosed head and neck cancer patients and their relatives']","['tobacco chewing', 'tobacco cessation intervention', 'tobacco cessation intervention, Chhattisgarh, India']",['quitting rates'],"[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040338', 'cui_str': 'Smokeless Tobacco'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0153381', 'cui_str': 'Malignant tumor of oral cavity'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}]","[{'cui': 'C0008038', 'cui_str': 'Chewing tobacco'}, {'cui': 'C0600549', 'cui_str': 'Tobacco Cessation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021201', 'cui_str': 'India'}]",[],105.0,0.0696842,This study will help in the evaluation of the attitude towards smokeless tobacco (SLT) in a population that has faced the adverse consequences from its use and changes brought by a diagnosis of HNC.,"[{'ForeName': 'Lokesh K', 'Initials': 'LK', 'LastName': 'Singh', 'Affiliation': 'Department of Psychiatry, AIIMS, Raipur, India.'}, {'ForeName': 'Ripu Daman', 'Initials': 'RD', 'LastName': 'Arora', 'Affiliation': 'Department of ENT & Head and Neck Surgery, AIIMS, Raipur, India.'}, {'ForeName': 'Sai Krishna', 'Initials': 'SK', 'LastName': 'Tikka', 'Affiliation': 'Department of Psychiatry, AIIMS, Raipur, India.'}, {'ForeName': 'Avinash', 'Initials': 'A', 'LastName': 'Shukla', 'Affiliation': 'Department of Psychiatry, AIIMS, Raipur, India.'}, {'ForeName': 'Sharda', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Department of Psychiatry, AIIMS, Raipur, India.'}, {'ForeName': 'Supriya', 'Initials': 'S', 'LastName': 'Mahant', 'Affiliation': 'Department of Psychiatry, AIIMS, Raipur, India.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': 'Department of Psychiatry, AIIMS, Raipur, India.'}]",Tobacco prevention & cessation,['10.18332/tpc/115028']
2589,32548361,An mHealth intervention to prevent postnatal smoking relapse: The RESPREMO study protocol.,"Up to 70% of women who quit smoking relapse after birth, usually within 3 months postpartum. The wide adoption of mobile technologies, especially smartphones, in recent years in low- and middle-income countries (LMICs) offers the possibility of low-cost, novel, and innovative mobile phone-based interventions for smoking relapse prevention. This study presents the protocol of the RESPREMO clinical trial for postnatal smoking relapse prevention for enrolled women, who recently gave birth and quit tobacco smoking before or during pregnancy, and their life partners. This work relies on data collected in two of the largest government-owned obstetrics and gynecology clinics in Cluj-Napoca, Romania. Seventy-five couples were randomized into one of three groups: a) 24 couples were allocated to the first intervention group and asked to install and use the xSmoker app; b) 26 couples were randomized to the second intervention group, who, in addition to the use of the xSmoker app, received text messages with content focused on motivation, problem solving, and dyadic efficacy; and c) 25 couples were randomized into a control group. Several measures of engagement with the xSmoker app were assessed, including duration of app use, the frequency of utilizing the tool to calculate savings from quitting, number of app-delivered challenges accepted by users, and number of app-delivered cessation and abstinence tips. If effective, RESPREMO is expected to have a sustainable impact on the prevention of postnatal relapse tobacco smoking with positive effects for both the mother and the newborn. The implications are beyond tobacco control, and relevant to the design and implementation of other mHealth behavioral interventions focused on the pregnancy and reproductive years in general.",2020,"Several measures of engagement with the xSmoker app were assessed, including duration of app use, the frequency of utilizing the tool to calculate savings from quitting, number of app-delivered challenges accepted by users, and number of app-delivered cessation and abstinence tips.","['Seventy-five couples were randomized into one of three groups: a) 24 couples were allocated to the first intervention group and asked to install and use the xSmoker app; b) 26 couples', 'enrolled women, who recently gave birth and quit tobacco smoking before or during pregnancy, and their life partners']","['xSmoker app, received text messages with content focused on motivation, problem solving', 'mHealth intervention']",['postnatal smoking relapse'],"[{'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0453996', 'cui_str': 'Tobacco smoking behavior - finding'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}]","[{'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",75.0,0.0398825,"Several measures of engagement with the xSmoker app were assessed, including duration of app use, the frequency of utilizing the tool to calculate savings from quitting, number of app-delivered challenges accepted by users, and number of app-delivered cessation and abstinence tips.","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Dascal', 'Affiliation': 'Center for Health Policy and Public Health, College of Political, Administrative and Communication Sciences, Babes-Bolyai University, Cluj-Napoca, Romania.'}, {'ForeName': 'Andreea', 'Initials': 'A', 'LastName': 'Rusu', 'Affiliation': 'Center for Health Policy and Public Health, College of Political, Administrative and Communication Sciences, Babes-Bolyai University, Cluj-Napoca, Romania.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Onisor', 'Affiliation': 'Center for Health Policy and Public Health, College of Political, Administrative and Communication Sciences, Babes-Bolyai University, Cluj-Napoca, Romania.'}, {'ForeName': 'Oana', 'Initials': 'O', 'LastName': 'Blaga', 'Affiliation': 'Center for Health Policy and Public Health, College of Political, Administrative and Communication Sciences, Babes-Bolyai University, Cluj-Napoca, Romania.'}, {'ForeName': 'Mckenzie', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': 'College of Human Medicine, Michigan State University, East Lansing, United States.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Meghea', 'Affiliation': 'Center for Health Policy and Public Health, College of Political, Administrative and Communication Sciences, Babes-Bolyai University, Cluj-Napoca, Romania.'}]",Tobacco prevention & cessation,['10.18332/tpc/118724']
2590,32548363,Impact of menthol delivery methods on smoker sensory perceptions.,"INTRODUCTION


Menthol can be added to cigarettes in several ways; these different delivery methods of menthol may lead to changes in sensory attributes, as well as perceived risk and appeal of these products.
METHODS


Using a randomized, controlled study design, 18 current, established menthol smokers were asked to sample Camel Crush and Camel Menthol cigarette products, crushed and uncrushed. Smoking behavior, exhaled carbon monoxide, subjective ratings, and perceived risk measures were assessed for each product.
RESULTS


Cigarette Evaluation Scale relief of craving scores for participants' preferred brand (mean: 5.3, SE: 0.3) were significantly higher (p=0.012) than Camel Menthol crushed (mean: 4.6, SE: 0.3) as were the Sensory Scale satisfaction scores (preferred brand mean: 6.9, SE: 0.7 compared to Camel Menthol crushed mean: 5.1, SE: 0.6; p=0.004). In addition, the average Sensory Scale smoke strength scores for participants' preferred brand (mean: 6.9, SE: 0.5) was also significantly higher than Camel Crush crushed (mean: 5.0, SE: 0.5; p=0.022). There were no significant differences in smoking topography measures, CO boosts, or perceived risk between Camel Crush or Camel Menthol products.
CONCLUSIONS


The delivery method and amount of menthol present in cigarettes did not appear to affect short-term smoking behavior, sensory perceptions, or perceived product risk among a small sample of current established adult menthol smokers. It is possible that consumers of cigarette products may be attracted to the innovative technology of the crushable filter capsule as opposed to the taste experience, however, further research is needed.",2020,"There were no significant differences in smoking topography measures, CO boosts, or perceived risk between Camel Crush or Camel Menthol products.
","['18 current, established menthol smokers were asked to sample Camel Crush and Camel Menthol cigarette products, crushed and uncrushed', 'smoker sensory perceptions']",['menthol delivery methods'],"['Cigarette Evaluation Scale relief of craving scores', 'Sensory Scale satisfaction scores', 'smoking topography measures, CO boosts, or perceived risk between Camel Crush or Camel Menthol products', 'average Sensory Scale smoke strength scores', 'Smoking behavior, exhaled carbon monoxide, subjective ratings, and perceived risk measures']","[{'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0006801', 'cui_str': 'Camelus'}, {'cui': 'C0185060', 'cui_str': 'Crushing'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}]","[{'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0006801', 'cui_str': 'Camelus'}, {'cui': 'C0185060', 'cui_str': 'Crushing'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",,0.0123522,"There were no significant differences in smoking topography measures, CO boosts, or perceived risk between Camel Crush or Camel Menthol products.
","[{'ForeName': 'Liane', 'Initials': 'L', 'LastName': 'Schneller', 'Affiliation': 'University of Rochester Medical Center, New York, United States.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Mahoney', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, United States.'}, {'ForeName': 'Maansi', 'Initials': 'M', 'LastName': 'Bansal-Travers', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, United States.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'McCann', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, United States.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': ""O'Connor"", 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, United States.'}]",Tobacco prevention & cessation,['10.18332/tpc/118437']
2591,32548702,"Association of diabetes-related autoantibodies with the incidence of asthma, eczema and allergic rhinitis in the TRIGR randomised clinical trial.","AIMS/HYPOTHESIS


This paper presents the relationship between islet autoantibodies, precursors of type 1 diabetes, and the development of persistent asthma, allergic rhinitis and atopic eczema.
METHODS


A total of 2159 newborns who had a first-degree relative with type 1 diabetes and selected HLA genotypes were followed until the youngest participant reached 10 years of age. Islet cell antibodies (ICA) were detected using indirect immunofluorescence. Autoantibodies to insulin (IAA), GAD (GADA), the tyrosine phosphatase-related insulinoma-associated 2 molecule (IA-2A) and zinc transporter 8 (ZnT8A) were quantified with the use of specific radiobinding assays. As an ancillary study, the incidence of asthma, allergic rhinitis and eczema was assessed in 1106 of these children using the International Study of Asthma and Allergies in Childhood (ISAAC) core questionnaire when the children were 9-11 years old. HRs with 95% CIs were calculated to depict the incidence of these diseases following seroconversion to autoantibody positivity.
RESULTS


The cumulative incidence of atopic eczema, allergic rhinitis and persistent asthma were 22%, 9% and 7.5%, respectively, by 9-11 years of age. The occurrence of diabetes-related autoantibodies showed a protective association with subsequently reported incidence of asthma and eczema. The incidence of rhinitis was not significantly related to the occurrence of IAA or GADA (statistical power was limited), but demonstrated the same inverse relationship as did the other diseases with ICA or when multiple autoantibodies first appeared together.
CONCLUSIONS/INTERPRETATION


The findings add evidence to the relationships between these atopic diseases and diabetes-related autoimmunity and also suggest that, for eczema, the interaction depends upon which autoantibody appeared first.
TRIAL REGISTRATION


ClinicalTrials.gov NCT00179777 Graphical abstract.",2020,"The incidence of rhinitis was not significantly related to the occurrence of IAA or GADA (statistical power was limited), but demonstrated the same inverse relationship as did the other diseases with ICA or when multiple autoantibodies first appeared together.
","['2159 newborns who had a first-degree relative with type 1 diabetes and selected HLA genotypes were followed until the youngest participant reached 10\xa0years of age', '1106 of these children using the International Study of Asthma and Allergies in Childhood (ISAAC) core questionnaire when the children were 9-11\xa0years old']",[],"['occurrence of IAA or GADA', 'cumulative incidence of atopic eczema, allergic rhinitis and persistent asthma', 'incidence of asthma, allergic rhinitis and eczema', 'Autoantibodies to insulin (IAA), GAD (GADA', 'incidence of rhinitis', 'Islet cell antibodies (ICA']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0444502', 'cui_str': 'First degree'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0019630', 'cui_str': 'Class II Histocompatibility Antigens'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",[],"[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0004358', 'cui_str': 'Autoantibody'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder'}, {'cui': 'C0008711', 'cui_str': 'Chronic rhinitis'}, {'cui': 'C0063900', 'cui_str': 'Anti-pancreatic islet cell antibody'}]",2159.0,0.0442462,"The incidence of rhinitis was not significantly related to the occurrence of IAA or GADA (statistical power was limited), but demonstrated the same inverse relationship as did the other diseases with ICA or when multiple autoantibodies first appeared together.
","[{'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Krischer', 'Affiliation': 'Health Informatics Institute, Morsani College of Medicine, University of South Florida, 3650 Spectrum Boulevard, Suite 100, Tampa, FL, 33612, USA. jeffrey.krischer@epi.usf.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cuthbertson', 'Affiliation': 'Health Informatics Institute, Morsani College of Medicine, University of South Florida, 3650 Spectrum Boulevard, Suite 100, Tampa, FL, 33612, USA.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Couluris', 'Affiliation': 'Department of Pediatrics, Morsani College of Medicine, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Knip', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Suvi M', 'Initials': 'SM', 'LastName': 'Virtanen', 'Affiliation': 'Unit of Public Health Promotion, National Institute for Health and Welfare, Helsinki, Finland.'}]",Diabetologia,['10.1007/s00125-020-05188-3']
2592,32548724,"Health economic evaluation of an internet intervention for depression (deprexis), a randomized controlled trial.","BACKGROUND


Depressive disorders often remain undiagnosed or are treated inadequately. Online-based programs may reduce the present treatment gap for depressive disorders and reduce disease-related costs. This study aimed to examine the potential of the internet intervention ""deprexis"" to reduce the total costs of statutory health insurance. Changes in depression severity, health-related quality of life and impairment in functioning were also examined.
METHOD


A total of 3805 participants with, at minimum, mild depressive symptoms were randomized to either a 12-week online intervention (deprexis) or a control condition. The primary outcome measure was statutory health insurance costs, estimated using health insurers' administrative data. Secondary outcomes were: depression severity, health-related quality of life, and impairment in functioning; assessed on patient's self-report at baseline, post-treatment, and three-months' and nine-months' follow-up.
RESULTS


In both groups, total costs of statutory health insurance decreased during the study period, but changes from baseline differed significantly. In the intervention group total costs decreased by 32% from 3139€ per year at baseline to 2119€ in the study year (vs. a mean reduction in total costs of 13% in the control group). In comparison to the control group, the intervention group also showed a significantly greater reduction in depression severity, and impairment in functioning and a significantly greater increase in health-related quality of life.
CONCLUSION


The study underlines the potential of innovative internet intervention programs in treating depressive disorders. The results suggest that the use of deprexis over a period of 12 weeks leads to a significant improvement in symptoms with a simultaneous reduction in the costs of statutory health insurance.",2020,"In comparison to the control group, the intervention group also showed a significantly greater reduction in depression severity, and impairment in functioning and a significantly greater increase in health-related quality of life.
","['3805 participants with, at minimum, mild depressive symptoms']","['innovative internet intervention programs', 'internet intervention', 'online intervention (deprexis) or a control condition']","['total costs of statutory health insurance', 'depression severity, health-related quality of life and impairment in functioning', 'total costs', 'depression severity, and impairment in functioning', 'health-related quality of life', ""statutory health insurance costs, estimated using health insurers' administrative data"", 'costs of statutory health insurance', ""depression severity, health-related quality of life, and impairment in functioning; assessed on patient's self-report at baseline, post-treatment, and three-months' and nine-months' follow-up""]","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0027452', 'cui_str': 'National Health Insurance'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0021675', 'cui_str': 'Insurers'}, {'cui': 'C1292785', 'cui_str': 'Administrative action'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",3805.0,0.0841955,"In comparison to the control group, the intervention group also showed a significantly greater reduction in depression severity, and impairment in functioning and a significantly greater increase in health-related quality of life.
","[{'ForeName': 'Viola', 'Initials': 'V', 'LastName': 'Gräfe', 'Affiliation': 'Department of Health Economics and Health Care Management, School of Public Health, Bielefeld University, Universitätsstraße 25, 33615, Bielefeld, Germany. viola.graefe@uni-bielefeld.de.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Greiner', 'Affiliation': 'Department of Health Economics and Health Care Management, School of Public Health, Bielefeld University, Universitätsstraße 25, 33615, Bielefeld, Germany.'}]",Health economics review,['10.1186/s13561-020-00273-0']
2593,32548771,Fast acquisition abdominal MRI study for the investigation of suspected acute appendicitis in paediatric patients.,"OBJECTIVES


To assess the diagnostic accuracy of fast acquisition MRI in suspected cases of paediatric appendicitis presenting to a tertiary referral hospital.
MATERIALS AND METHODS


A prospective study was undertaken between May and October 2017 of 52 children who presented with suspected appendicitis and were referred for an abdominal ultrasound. All patients included in this study received both an abdominal ultrasound and five-sequence MRI consisting of axial and coronal gradient echo T2 scans, fat-saturated SSFSE and a diffusion-weighted scan. Participants were randomised into groups of MRI with breath-holds or MRI with free breathing. A patient satisfaction survey was also carried out. Histopathology findings, where available, were used as a gold standard for the purposes of data analysis. Statistical analysis was performed, and p values < 0.05 were considered statistically significant.
RESULTS


Ultrasound had a sensitivity and specificity of 25% and 92.9%, respectively. MRI with breath-hold had a sensitivity and specificity of 81.8% and 66.7%, respectively, whilst MRI with free breathing was superior with sensitivity and specificity of 92.3% and 84.2%, respectively. MRI with free breathing was also more time efficient (p < 0.0001). Group statistics were comparable (p < 0.05).
CONCLUSIONS


The use of fast acquisition MRI protocols, particularly free breathing sequences, for patients admitted with suspected appendicitis can result in faster diagnosis, treatment and discharge. It also has a statistically significant diagnostic advantage over ultrasound. Additionally, the higher specificity of MR can reduce the number of negative appendectomies performed in tertiary centres.",2020,MRI with free breathing was also more time efficient (p < 0.0001).,"['suspected cases of paediatric appendicitis presenting to a tertiary referral hospital', '52 children who presented with suspected appendicitis and were referred for an abdominal ultrasound', 'patients admitted with suspected appendicitis', 'suspected acute appendicitis in paediatric patients']","['fast acquisition MRI', 'MRI with breath-holds or MRI with free breathing', 'abdominal ultrasound and five-sequence MRI consisting of axial and coronal gradient echo T2 scans, fat-saturated SSFSE and a diffusion-weighted scan', 'fast acquisition MRI protocols']",['sensitivity and specificity'],"[{'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0235744', 'cui_str': 'Interrupted breathing'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}]",52.0,0.0479346,MRI with free breathing was also more time efficient (p < 0.0001).,"[{'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'James', 'Affiliation': 'Department of Radiology, Cork University Hospital, Cork, Ireland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Duffy', 'Affiliation': 'Department of Radiology, Cork University Hospital, Cork, Ireland.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Kavanagh', 'Affiliation': 'Department of Radiology, Cork University Hospital, Cork, Ireland.'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'Carey', 'Affiliation': 'Department of Radiology, Cork University Hospital, Cork, Ireland.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Power', 'Affiliation': 'Department of Radiology, Cork University Hospital, Cork, Ireland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ryan', 'Affiliation': 'Department of Radiology, Cork University Hospital, Cork, Ireland.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Joyce', 'Affiliation': 'Department of Radiology, University College Cork, Cork, Ireland.'}, {'ForeName': 'Aoife', 'Initials': 'A', 'LastName': 'Feeley', 'Affiliation': 'School of Medicine, University College Cork, Cork, Ireland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Murphy', 'Affiliation': 'PET/CT-MRI Unit, Cork University Hospital, Cork, Ireland.'}, {'ForeName': 'Emmet', 'Initials': 'E', 'LastName': 'Andrews', 'Affiliation': 'Department of Surgery, Cork University Hospital, Cork, Ireland.'}, {'ForeName': 'Mark F', 'Initials': 'MF', 'LastName': 'McEntee', 'Affiliation': 'Department of Radiography, University College Cork, Cork, Ireland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'Department of Radiology, Cork University Hospital, Cork, Ireland.'}, {'ForeName': 'Conor', 'Initials': 'C', 'LastName': 'Bogue', 'Affiliation': 'Department of Radiology, Cork University Hospital, Cork, Ireland.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Maher', 'Affiliation': 'Department of Radiology, Cork University Hospital, Cork, Ireland.'}, {'ForeName': 'Owen J', 'Initials': 'OJ', 'LastName': ""O' Connor"", 'Affiliation': 'Department of Radiology, Cork University Hospital, Cork, Ireland. oj.oconnor@ucc.ie.'}]",Insights into imaging,['10.1186/s13244-020-00882-7']
2594,32548774,Demonstrated health care cost savings for women: findings from a community health worker intervention designed to address depression and unmet social needs.,"To evaluate the impact of a community health worker intervention (CHW) (referred to as Personalized Support for Progress (PSP)) on all-cause health care utilization and cost of care compared with Enhanced Screening and Referral (ESR) among women with depression. A total of 223 patients (111 in PSP and 112 in ESR randomly assigned) from three women's health clinics with elevated depressive symptoms were enrolled in the study. Their electronic health records were queried to extract all-cause health care encounters along with the corresponding billing information 12 months before and after the intervention, as well as during the first 4-month intervention period. The health care encounters were then grouped into three mutually exclusive categories: high-cost (> US$1000 per encounter), medium-cost (US$201-$999), and low-cost (≤ US$200). A difference-in-difference analysis of mean total charge per patient between PSP and ESR was used to assess cost differences between treatment groups. The results suggest the PSP group was associated with a higher total cost of care at the baseline; taking this baseline difference into account, the PSP group was associated with lower mean total charge amounts (p = 0.008) as well as a reduction in the frequency of high-cost encounters (p < 0.001) relative to the ESR group during the post-intervention period. Patient-centered interventions that address unmet social needs in a high-cost population via CHW may be a cost-effective approach to improve quality of care and patient outcomes.",2020,A total of 223 patients (111 in PSP and 112 in ESR randomly assigned) from three women's health clinics with elevated depressive symptoms were enrolled in the study.,"[""223 patients (111 in PSP and 112 in ESR randomly assigned) from three women's health clinics with elevated depressive symptoms were enrolled in the study"", 'women with depression', 'women']","['community health worker intervention (CHW', 'Enhanced Screening and Referral (ESR']","['total cost of care', 'mean total charge amounts', 'frequency of high-cost encounters']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0303403', 'cui_str': 'Indium-111'}, {'cui': 'C0038868', 'cui_str': 'Progressive supranuclear palsy'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0080339', 'cui_str': ""Woman's Health""}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205250', 'cui_str': 'High'}]",223.0,0.0202653,A total of 223 patients (111 in PSP and 112 in ESR randomly assigned) from three women's health clinics with elevated depressive symptoms were enrolled in the study.,"[{'ForeName': 'Ellen Robin', 'Initials': 'ER', 'LastName': 'Embick', 'Affiliation': 'School of Medicine and Dentistry, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Maeng', 'Affiliation': 'Department of Psychiatry, University of Rochester Medical Center, 300 Crittenden Boulevard, Rochester, NY, 14642, USA.'}, {'ForeName': 'Iwona', 'Initials': 'I', 'LastName': 'Juskiewicz', 'Affiliation': 'Department of Psychiatry, University of Rochester Medical Center, 300 Crittenden Boulevard, Rochester, NY, 14642, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cerulli', 'Affiliation': 'Department of Psychiatry, University of Rochester Medical Center, 300 Crittenden Boulevard, Rochester, NY, 14642, USA.'}, {'ForeName': 'Hugh F', 'Initials': 'HF', 'LastName': 'Crean', 'Affiliation': 'School of Nursing, University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Marsha', 'Initials': 'M', 'LastName': 'Wittink', 'Affiliation': 'Department of Psychiatry, University of Rochester Medical Center, 300 Crittenden Boulevard, Rochester, NY, 14642, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Poleshuck', 'Affiliation': 'Department of Psychiatry, University of Rochester Medical Center, 300 Crittenden Boulevard, Rochester, NY, 14642, USA. Ellen_Poleshuck@urmc.rochester.edu.'}]",Archives of women's mental health,['10.1007/s00737-020-01045-9']
2595,32548775,Revascularization in cardiogenic shock.,"Approximately 10% of patients with acute myocardial infarction develop cardiogenic shock. Randomized studies have shown a significant improvement in survival with early revascularization, which now represents the most important cornerstone in the treatment of infarct-related cardiogenic shock. In the vast majority of cases, this is achieved by percutaneous coronary intervention (PCI). In cases of complex coronary anatomy or mechanical complications, the Heart Team should be consulted promptly. The randomized CULPRIT-SHOCK study showed a survival advantage for patients with multivessel coronary artery disease and a percutaneous revascularization strategy who were treated by culprit-lesion-only PCI compared with immediate multivessel PCI. There are currently few data on anticoagulation and antiplatelet therapy in cardiogenic shock as well as on active mechanical circulatory support in this setting.",2020,"Randomized studies have shown a significant improvement in survival with early revascularization, which now represents the most important cornerstone in the treatment of infarct-related cardiogenic shock.","['patients with multivessel coronary artery disease and a\xa0percutaneous revascularization strategy who were treated by culprit-lesion-only PCI compared with immediate multivessel PCI', 'cardiogenic shock', 'patients with acute myocardial infarction develop cardiogenic shock']",[],['survival'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}]",[],"[{'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.0639726,"Randomized studies have shown a significant improvement in survival with early revascularization, which now represents the most important cornerstone in the treatment of infarct-related cardiogenic shock.","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Freund', 'Affiliation': 'Department of Internal Medicine/Cardiology, Heart Center Leipzig at University of Leipzig, Strümpellstr.\xa039, 04289, Leipzig, Germany. anne.freund@medizin.uni-leipzig.de.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Desch', 'Affiliation': 'Department of Internal Medicine/Cardiology, Heart Center Leipzig at University of Leipzig, Strümpellstr.\xa039, 04289, Leipzig, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Department of Internal Medicine/Cardiology, Heart Center Leipzig at University of Leipzig, Strümpellstr.\xa039, 04289, Leipzig, Germany.'}]",Herz,['10.1007/s00059-020-04956-6']
2596,32548811,Albumin-Bilirubin (ALBI) Grade-Based Nomogram for Patients with Hepatocellular Carcinoma Undergoing Transarterial Chemoembolization.,"BACKGROUND/AIM


The prognosis of patients with hepatocellular carcinoma (HCC) undergoing transarterial chemoembolization (TACE) is highly heterogeneous because of variable characteristics of tumor burden and liver dysfunction. We aimed to propose and validate an albumin-bilirubin (ALBI) grade-based prognostic nomogram for HCC patients undergoing TACE.
METHODS


A total of 1051 patients with HCC undergoing TACE were randomly assigned to derivation (n = 525) and validation (n = 526) set in this retrospective study based on prospective data. The multivariate Cox proportional hazards model in derivation set was used to generate the nomogram. The predictive accuracy of the nomogram was evaluated by discrimination and calibration tests.
RESULTS


In multivariate analysis, presence of ascites, ALBI grade 2-3, serum ɑ-fetoprotein level ≥ 400 ng/mL, total tumor volume ≥ 396 cm 3 , presence of vascular invasion, and poor performance status were independently associated with decreased survival of patients in the derivation set. Each patient had an individualized score from 0 to 41 by adding up the points from these six prognostic predictors. The nomogram generated from the derivation set had a concordance index of 0.72 (95% confidence interval [CI] 0.63-0.82). Discrimination test in the validation set provided a good concordance index 0.72 (95% CI 0.62-0.81), and the calibration plots consistently matched the ideal 45-degree reference line for 3- and 5-year survival prediction.
CONCLUSIONS


The ALBI grade-based prognostic model can well discriminate the survival in HCC patients undergoing TACE. The proposed easy-to-use nomogram may accurately predict the survival at 3 and 5 years for individual HCC patient in the precision medicine era.",2020,Discrimination test in the validation set provided a good concordance index 0.72,"['1051 patients with HCC undergoing TACE', 'HCC patients undergoing TACE', 'Patients with Hepatocellular Carcinoma Undergoing Transarterial Chemoembolization', 'patients with hepatocellular carcinoma (HCC) undergoing']",['transarterial chemoembolization (TACE'],"['albumin-bilirubin (ALBI) grade-based prognostic nomogram', 'Albumin-Bilirubin (ALBI', 'total tumor volume\u2009≥']","[{'cui': 'C0450319', 'cui_str': '1051'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0522522', 'cui_str': 'Transarterial approach'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}]","[{'cui': 'C0522522', 'cui_str': 'Transarterial approach'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}]","[{'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1450294', 'cui_str': 'Nomogram chart'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0475276', 'cui_str': 'Tumor volume'}]",1051.0,0.0497399,Discrimination test in the validation set provided a good concordance index 0.72,"[{'ForeName': 'Shu-Yein', 'Initials': 'SY', 'LastName': 'Ho', 'Affiliation': 'Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chia-Yang', 'Initials': 'CY', 'LastName': 'Hsu', 'Affiliation': 'Faculty of Medicine, National Yang-Ming University School of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Po-Hong', 'Initials': 'PH', 'LastName': 'Liu', 'Affiliation': 'Faculty of Medicine, National Yang-Ming University School of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Rheun-Chuan', 'Initials': 'RC', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chih-Chieh', 'Initials': 'CC', 'LastName': 'Ko', 'Affiliation': 'Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Yi-Hsiang', 'Initials': 'YH', 'LastName': 'Huang', 'Affiliation': 'Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chien-Wei', 'Initials': 'CW', 'LastName': 'Su', 'Affiliation': 'Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ming-Chih', 'Initials': 'MC', 'LastName': 'Hou', 'Affiliation': 'Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Teh-Ia', 'Initials': 'TI', 'LastName': 'Huo', 'Affiliation': 'Department of Medical Research, Taipei Veterans General Hospital, No. 201, Sec. 2, Shipai Rd., Taipei, 11217, Taiwan. tihuo@vghtpe.gov.tw.'}]",Digestive diseases and sciences,['10.1007/s10620-020-06384-2']
2597,32548849,Duration of adhesion of swallowed alginates to distal oesophageal mucosa: Implications for topical therapy of oesophageal diseases.,"BACKGROUND


We have previously shown, ex vivo, that alginate solutions can have a topical protective effect on oesophageal mucosal biopsies exposed to simulated gastric juice. Oesophageal mucosal impedance can measure the duration of mucosal adherence of ionic solutions since the impedance drops when the solution is present, and rises to baseline as the solution clears.
AIM


To investigate the in vivo duration of adhesion of swallowed alginate solution to distal oesophageal mucosa.
METHODS


We studied 20 healthy volunteers and 10 patients with heartburn. A pH-impedance catheter was inserted, and baseline distal channel oesophageal impedance measured. Healthy volunteers received 10 mL of either sodium alginate (Gaviscon Advance), Gaviscon placebo (no alginate) or viscous slurry (saline mixed with sucralose), given in a randomised, single-blinded order over three visits. Patients received either sodium alginate or placebo on two visits. Initial impedance drop was measured, then 1-minute mean impedance was measured each minute until ≥75% recovery to baseline.
RESULTS


In healthy volunteers, sodium alginate adhered to the oesophageal mucosa for longer than placebo or viscous slurry (10.4 [8.7] minutes vs 1.1 [1.6] vs 3.6 [4.0], P < 0.01). In patients, sodium alginate adhered to the oesophageal mucosa for longer than placebo (9.0 (5.4) vs 3.7 (4.1), P < 0.01).
CONCLUSIONS


Sodium alginate solution adhered to the oesophageal mucosa for significantly longer than placebo or viscous slurry. This demonstrates that alginates could confer a protective benefit due to mucoadhesion and can be a basis for further development of topical protectants and for topical drug delivery in oesophageal disease.",2020,"In healthy volunteers, sodium alginate adhered to the oesophageal mucosa for longer than placebo or viscous slurry (10.4 [8.7] minutes vs 1.1 [1.6] vs 3.6 [4.0], P < 0.01).","['oesophageal diseases', 'healthy volunteers', '20 healthy volunteers and 10 patients with heartburn', 'distal oesophageal mucosa', 'Healthy volunteers']","['sodium alginate or placebo', '10\xa0mL of either sodium alginate (Gaviscon Advance), Gaviscon placebo (no alginate) or viscous slurry ', 'saline mixed with sucralose', 'swallowed alginate solution', 'placebo']",['oesophageal mucosa'],"[{'cui': 'C0014852', 'cui_str': 'Disorder of esophagus'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018834', 'cui_str': 'Heartburn'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0227176', 'cui_str': 'Esophageal mucous membrane structure'}]","[{'cui': 'C0142791', 'cui_str': 'Sodium alginate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0061146', 'cui_str': 'Gaviscon'}, {'cui': 'C0002040', 'cui_str': 'Alginates'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0077046', 'cui_str': 'sucralose'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0227176', 'cui_str': 'Esophageal mucous membrane structure'}]",20.0,0.0734851,"In healthy volunteers, sodium alginate adhered to the oesophageal mucosa for longer than placebo or viscous slurry (10.4 [8.7] minutes vs 1.1 [1.6] vs 3.6 [4.0], P < 0.01).","[{'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Sonmez', 'Affiliation': 'Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Cathal', 'Initials': 'C', 'LastName': 'Coyle', 'Affiliation': 'Reckitt Benckiser, Slough, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Sifrim', 'Affiliation': 'Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Woodland', 'Affiliation': 'Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15884']
2598,32548854,S100B and NSE in Cluster Headache - Evidence for Glial Cell Activation?,"OBJECTIVE


Neuronal-specific enolase (NSE) and protein S100B have gained considerable interest as the markers of CNS injury, glial cell activation, and/or blood-brain barrier (BBB) disruption. No studies have investigated NSE and S100B in cluster headache (CH), but these biomarkers could contribute to the understanding of CH.
METHODS


Patients with episodic CH in bout (eCHa), in remission (eCHr), and chronic CH (cCH) were included in this randomized, double-blind, placebo-controlled, 2-way cross-over provocation study carried out at the Danish Headache Center. The primary endpoints included (1) differences of NSE and S100B in between groups (eCHa, eCHr, and cCH) at baseline; (2) differences over time in plasma concentrations of NSE and S100B between patient developing an attack and those who did not; (3) differences in plasma concentrations over time of NSE and S100B between active day and placebo day. Baseline findings were compared to the historical data on migraine patients and healthy controls and presented with means ± SD.
RESULTS


Nine eCHa, 9 eCHr, and 13 cCH patients completed the study and blood samples from 11 CGRP-induced CH attacks were obtained. There were no differences in NSE levels between CH groups at baseline, but CH patients in active disease phase had higher levels compared with 32 migraine patients (9.1 ± 2.2 µg/L vs 6.0 ± 2.2 µg/L, P < .0001) and 6 healthy controls (9.1 ± 2.2 µg/L vs 7.3 ± 2.0 µg/L, P = .007). CGRP-infusion caused no NSE changes and, but a slight, non-significant, increase in NSE was seen in patients who reported a CGRP-induced CH attack (2.39 µg/L, 95% Cl [-0.26, 3.85], P = .061). At baseline S100B levels in eCHa patients were higher compared to cCH patients (0.06 ± 0.02 µg/L vs 0.04 ± 0.02 µg/L, P = .018). Infusion of CGRP and CGRP-induced attacks did not change S100B levels. Apart from induced CH-attacks no other adverse events were noted.
CONCLUSIONS


At baseline eCHa patients had higher S100B plasma levels than cCH patients and there was a slight, however not significant, NSE increase in response to CGRP-induced CH attack. Our findings suggest a possible role of an ictal activation of glial cells in CH pathophysiology, but further studies are warranted.",2020,"CGRP-infusion caused no NSE changes and, but a slight, non-significant, increase in NSE was seen in patients who reported a CGRP-induced CH attack (2.39 µg/L, 95% Cl","['Patients with episodic CH in bout (eCHa), in remission (eCHr), and chronic CH (cCH', 'Nine eCHa, 9 eCHr, and 13 cCH patients']","['CGRP and CGRP', 'CGRP-infusion', 'placebo']","['S100B plasma levels', 'NSE', 'CH attack', 'adverse events', 'NSE and S100B in between groups (eCHa, eCHr, and cCH) at baseline', 'NSE levels', 'plasma concentrations of NSE and S100B', 'plasma concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0393739', 'cui_str': 'Episodic cluster headache'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0009088', 'cui_str': 'Cluster headache'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0006669', 'cui_str': 'Calcitonin gene-related peptide'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0031691', 'cui_str': 'Enolase'}, {'cui': 'C0009088', 'cui_str': 'Cluster headache'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.116189,"CGRP-infusion caused no NSE changes and, but a slight, non-significant, increase in NSE was seen in patients who reported a CGRP-induced CH attack (2.39 µg/L, 95% Cl","[{'ForeName': 'Agneta H', 'Initials': 'AH', 'LastName': 'Snoer', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anne Luise H', 'Initials': 'ALH', 'LastName': 'Vollesen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Rasmus Paulin', 'Initials': 'RP', 'LastName': 'Beske', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Guo', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hoffmann', 'Affiliation': ""Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Niklas R', 'Initials': 'NR', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Martinussen', 'Affiliation': 'Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Rigmor H', 'Initials': 'RH', 'LastName': 'Jensen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}]",Headache,['10.1111/head.13864']
2599,32548864,The effect of a hydrogel made by Nigella sativa L. on acne vulgaris: A randomized double-blind clinical trial.,"Nigella sativa L. (black seed) is one of the main medicinal plants frequently cited in traditional Persian medicine manuscripts for management of acne vulgaris. The present study was designed to investigate the efficacy of a topical preparation from N. sativa in acne vulgaris. In a randomized double-blind controlled clinical trial, 60 patients (30 patients in treatment and 30 in placebo group) were randomly received N. sativa hydrogel (standardized based on thymoquinone) or placebo hydrogel, twice daily for 60 days. The Investigator's Global Assessment (IGA) grading score was recorded for each patient. Moreover, acne disability index (ADI) was evaluated using a standard questionnaire filled out by the patients at the beginning and end of the study. A 78% mean reduction in the IGA score on the N. sativa-treated group was recorded compared with 3.3% on the vehicle-treated one. Significant reductions in the number of comedones, papules, and pustules were observed in the treatment group compared with placebo after 2 months. Also, ADI was decreased 63.49% in the treatment versus 4.5% in the placebo groups. No adverse event was recorded. N. sativa hydrogel had significant effects on improving the symptoms of acne vulgaris with acceptable tolerability.",2020,"Significant reductions in the number of comedones, papules, and pustules were observed in the treatment group compared with placebo after 2 months.","['60 patients (30 patients in treatment and 30 in placebo group', 'acne vulgaris']","['Nigella sativa L. (black seed', 'sativa hydrogel (standardized based on thymoquinone) or placebo hydrogel', 'hydrogel made by Nigella sativa L', 'placebo']","['acne disability index (ADI', 'IGA score', 'number of comedones, papules, and pustules', 'ADI', ""Investigator's Global Assessment (IGA) grading score"", 'symptoms of acne vulgaris with acceptable tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}]","[{'cui': 'C1140702', 'cui_str': 'Cumin, Black'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0076611', 'cui_str': 'thymoquinone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0221228', 'cui_str': 'Comedone'}, {'cui': 'C0332563', 'cui_str': 'Papule'}, {'cui': 'C0241157', 'cui_str': 'Pustule'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}]",60.0,0.334872,"Significant reductions in the number of comedones, papules, and pustules were observed in the treatment group compared with placebo after 2 months.","[{'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Soleymani', 'Affiliation': 'Department of Traditional Pharmacy, School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Zargaran', 'Affiliation': 'Department of Traditional Pharmacy, School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Hosein', 'Initials': 'MH', 'LastName': 'Farzaei', 'Affiliation': 'Pharmaceutical Sciences Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Iranpanah', 'Affiliation': ""Student's Research Committee, Faculty of Pharmacy, Kermanshah University of Medical Sciences, Kermanshah, Iran.""}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Heydarpour', 'Affiliation': 'Social Development & Health Promotion Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Najafi', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Roja', 'Initials': 'R', 'LastName': 'Rahimi', 'Affiliation': 'Department of Traditional Pharmacy, School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6739']
2600,32548941,Reduction of enlarged facial pore using ion-paired amino acid through enhancement in skin permeation and exfoliation: A placebo-controlled in vivo study.,"BACKGROUND


Serine is a hypoallergenic but inefficient chemical exfoliant. Serine paired with arginine (ion-paired amino acid, IPA) shows enhanced lipophilicity, skin permeation, and exfoliation efficacy.
AIM


This study was conducted to determine whether exfoliation using an emulsion containing IPA could reduce enlarged facial pores and improve the dermis density.
METHODS


IPA formation was validated by spectroscopic analysis. Enhanced permeability and exfoliation efficacy were evaluated ex vivo using porcine skin. In a clinical trial, healthy Korean women aged 20-49 years (mean age ± SD: 35.6 ± 8.6, n = 64) were evaluated, and the right and left sides of the cheeks were randomly chosen. An emulsion containing 4.0% IPA and placebo emulsion were applied to each side for 6 weeks. To evaluate pore sizes following treatment, the number of enlarged facial pores, inner skin structures from the stratum corneum to epidermal-dermal interface, and dermal density on each cheek of the participants were assessed.
RESULTS


IPA showed a significantly increased partition coefficient in n-octanol-water. In porcine skin, permeation of serine after 12 hour was 70% higher for the IPA than for serine alone at the same percent weight concentrations. In the clinical trial, after 6 weeks, the number of enlarged facial pores was changed by -19.317% in the IPA emulsion group (P < .001) and -2.930% in placebo emulsion group (P = .254).
CONCLUSION


Exfoliation with an IPA-containing emulsion reduced enlarged facial pores and increased the dermis density. IPA, effective mild exfoliator, can be used as a major ingredient for the cosmeceutical skincare products in the future.",2020,"In porcine skin, permeation of serine after 12 hour was 70% higher for the IPA than for serine alone at the same percent weight concentrations.","['healthy Korean women aged 20-49\xa0years (mean age\xa0±\xa0SD: 35.6\xa0±\xa08.6, n\xa0=\xa064) were evaluated, and the right and left sides of the cheeks were randomly chosen']","['arginine (ion-paired amino acid, IPA', 'IPA-containing emulsion', 'placebo emulsion', 'IPA emulsion', 'emulsion containing 4.0% IPA and placebo emulsion', 'emulsion containing IPA', 'placebo']","['enlarged facial pores', 'number of enlarged facial pores', 'dermis density', 'partition coefficient', 'lipophilicity, skin permeation, and exfoliation efficacy', 'skin permeation and exfoliation', 'Enhanced permeability and exfoliation efficacy']","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517879', 'cui_str': '8.6'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0441987', 'cui_str': 'Side'}, {'cui': 'C0007966', 'cui_str': 'Cheek structure'}]","[{'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0022023', 'cui_str': 'Ions'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0014020', 'cui_str': 'Emulsions'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0011646', 'cui_str': 'Dermis structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0040439', 'cui_str': 'Exfoliation of teeth'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}]",64.0,0.156535,"In porcine skin, permeation of serine after 12 hour was 70% higher for the IPA than for serine alone at the same percent weight concentrations.","[{'ForeName': 'Koo Chul', 'Initials': 'KC', 'LastName': 'Kwon', 'Affiliation': 'LG Household & Health Care (LG H&H), LG Science Park R&D Center, Seoul, Korea.'}, {'ForeName': 'Sung Woo', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': 'LG Household & Health Care (LG H&H), LG Science Park R&D Center, Seoul, Korea.'}, {'ForeName': 'Hongmin', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'LG Household & Health Care (LG H&H), LG Science Park R&D Center, Seoul, Korea.'}, {'ForeName': 'Hyungjoon', 'Initials': 'H', 'LastName': 'Jeon', 'Affiliation': 'LG Household & Health Care (LG H&H), LG Science Park R&D Center, Seoul, Korea.'}, {'ForeName': 'Sang-Wook', 'Initials': 'SW', 'LastName': 'Park', 'Affiliation': 'LG Household & Health Care (LG H&H), LG Science Park R&D Center, Seoul, Korea.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13479']
2601,32548951,Generalizability of harm and pain expectations after exposure in chronic low back pain patients.,"BACKGROUND


Exposure treatments are shown to be effective in reducing pain-related fear and the perceived harmfulness of physical activities. However, due to the fragility of extinction its stability is questionable. We investigated the generalizability of exposure effects in chronic low back pain (CLBP) patients by integrating a behavioral test in the context of an intervention study.
METHODS


The study is an additional analysis of a randomized controlled trial investigating the efficacy of exposure in vivo. A total of 67 CLBP patients were randomly assigned to one of the three groups: Exposure-short (EXP-S); exposure-long (EXP-L) and cognitive behavioral therapy (CBT). Participants rated the expected harmfulness of daily activities (Photograph Series of Daily Activities) before and after therapy. Post-treatment participants were confronted with an individually tailored, threatening movement in a new context. Harm and pain expectations before the exposure were compared to the actual experience after exposure.
RESULTS


We found that EXP leads to more strongly reduced harm expectations (F(2,50) = 11.37, p < .001, η 2   = 0.31) compared to CBT, regardless of the duration of EXP. After therapy, patients expected less harm (F(2,50) = 3.61, p = .034, η 2   = 0.13) but not less pain (F(2,50) = 3.61, p = .034, η 2   = 0.13) when confronted with a novel movement.
CONCLUSIONS


Exposure successfully reduced harm but not pain expectations in patients with CLBP. Further, preliminary results showed that these specific exposure effects were generalized to a novel activity in a different context outside therapy.
SIGNIFICANCE


This study investigats the generalizability and stability of exposure effects in patients with CLBP by combining a behavioral test with an intervention study. We found strong and stable effects on harm expectations but not on pain expectations. Results show promising preliminary evidence that reduced harm expectations can be generalized to a novel threatening activity in a new context. Clinical implications of our findings suggest that exposure treatment would benefit from a clear focus on harm expectations.",2020,"After therapy, patients expected less harm (F(2,50) = ","['patients with CLBP', 'chronic low back pain patients', 'chronic low back pain (CLBP) patients', '67 CLBP patients', 'patients with CLBP by combining a behavioral test with an intervention study', 'patients expected less harm (F(2,50)\xa0']",['Exposure-short (EXP-S); exposure-long (EXP-L) and cognitive behavioral therapy (CBT'],"['harmfulness of daily activities (Photograph Series of Daily Activities', 'Harm and pain expectations', 'pain expectations', 'Generalizability of harm and pain expectations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0683444', 'cui_str': 'Behavioral Test'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}]",67.0,0.0394039,"After therapy, patients expected less harm (F(2,50) = ","[{'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Riecke', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Rief', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Johan W S', 'Initials': 'JWS', 'LastName': 'Vlaeyen', 'Affiliation': 'KU Leuven, Health Psychology Research Group, Leuven, Belgium.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Glombiewski', 'Affiliation': 'Department of Psychology, University of Koblenz-Landau, Landau, Germany.'}]","European journal of pain (London, England)",['10.1002/ejp.1604']
2602,32548966,Does eating in the absence of hunger extend to healthy snacks in children?,"OBJECTIVES


To assess if eating in the absence of hunger (EAH) extends to healthier snacks and examine the relationship between the home food environment and EAH in children with normal weight (NW) or overweight/obesity (OB) who are at low risk (LR) or high risk (HR) for obesity based on maternal obesity.
METHODS


EAH was assessed after lunch and dinner when children received either low energy dense fruit snacks or high energy dense sweet/savoury snacks. The availability of obesogenic foods in the home was assessed by the Home Food Inventory.
RESULTS


Data showed significant main effects of risk group (P=.0003) and snack type (P < .001). EAH was significantly greater in HR-OB (284±8 kcal) than LR-NW (249±9 kcal) or HR-NW (251±8 kcal) children. Serving fruit rather than sweet/savoury snacks reduced energy intake, on average, by 60% (223 kcal) across risk groups. For each unit increase in the obesogenic home food environment, EAH of sweet/savoury snacks decreased by 1.83 calories.
CONCLUSIONS


Offering low energy dense snacks after a meal can moderate EAH and increase children's intake of healthy foods. Increased access to obesogenic foods in the home may reduce the salience of high energy dense snacks when they become available in other settings.",2020,"RESULTS


Data showed significant main effects of risk group (P=.0003) and snack type (P < .001).",['children with normal weight (NW) or overweight/obesity (OB) who are at low risk (LR) or high risk (HR) for obesity based on maternal obesity'],"['low energy dense fruit snacks or high energy dense sweet/savoury snacks', 'Serving fruit rather than sweet/savoury snacks']","['energy intake', 'EAH', 'HR-OB', 'obesogenic home food environment, EAH of sweet/savoury snacks']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0746977', 'cui_str': 'Maternal Obesity'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}]","[{'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}]",,0.0581201,"RESULTS


Data showed significant main effects of risk group (P=.0003) and snack type (P < .001).","[{'ForeName': 'Tanja V E', 'Initials': 'TVE', 'LastName': 'Kral', 'Affiliation': 'Department of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Reneé H', 'Initials': 'RH', 'LastName': 'Moore', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Chittams', 'Affiliation': 'Department of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': ""O'Malley"", 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Jones', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Quinn', 'Affiliation': 'Department of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Jennifer O', 'Initials': 'JO', 'LastName': 'Fisher', 'Affiliation': 'Department of Social and Behavioral Sciences, College of Public Health, Temple University, Philadelphia, Pennsylvania, USA.'}]",Pediatric obesity,['10.1111/ijpo.12659']
2603,29741714,Variety of Enriching Early-Life Activities Linked to Late-Life Cognitive Functioning in Urban Community-Dwelling African Americans.,"OBJECTIVES


The early environment is thought to be a critical period in understanding the cognitive health disparities African Americans face today. Much is known about the positive role enriching environments have in mid- and late-life and the negative function adverse experiences have in childhood; however, little is known about the relationship between enriching childhood experiences and late-life cognition. The current study examines the link between a variety of enriching early-life activities and late-life cognitive functioning in a sample of sociodemographic at-risk older adults.
METHOD


This study used data from African Americans from the Brain and Health Substudy of the Baltimore Experience Corps Trial (M = 67.2, SD = 5.9; N = 93). Participants completed a battery of neuropsychological assessments and a seven-item retrospective inventory of enriching activities before age 13.
RESULTS


Findings revealed that a greater enriching early-life activity score was linked to favorable outcomes in educational attainment, processing speed, and executive functioning.
DISCUSSION


Results provide promising evidence that enriching early environments are associated with late-life educational and cognitive outcomes. Findings support the cognitive reserve and engagement frameworks, and have implications to extend life-span prevention approaches when tackling age-related cognitive declines, diseases, and health disparities.",2019,"RESULTS


Findings revealed that a greater enriching early-life activity score was linked to favorable outcomes in educational attainment, processing speed, and executive functioning.
","['a sample of sociodemographic at-risk older adults', 'Participants completed a battery of neuropsychological assessments and a seven-item retrospective inventory of enriching activities before age 13', 'Urban Community-Dwelling African Americans', 'African Americans from the Brain and Health Substudy of the Baltimore Experience Corps Trial (M = 67.2, SD = 5.9; N = 93']",[],"['Variety of Enriching Early-Life Activities', 'educational attainment, processing speed, and executive functioning', 'enriching early-life activity score']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",93.0,0.0314309,"RESULTS


Findings revealed that a greater enriching early-life activity score was linked to favorable outcomes in educational attainment, processing speed, and executive functioning.
","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Chan', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Jeanine M', 'Initials': 'JM', 'LastName': 'Parisi', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Kyle D', 'Initials': 'KD', 'LastName': 'Moored', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'Carlson', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}]","The journals of gerontology. Series B, Psychological sciences and social sciences",['10.1093/geronb/gby056']
2604,30389202,Transition Readiness for Talking With Providers in Urban Youth With Asthma: Associations With Medication Management.,"PURPOSE


Teen readiness assessments may provide a developmental indicator of the transfer of responsibility for health self-management from caregivers to teens. Among urban adolescents with asthma, we aimed to describe teen readiness for talking with providers and identify how readiness relates to responsibility for asthma management, medication beliefs, and clinical outcomes.
METHODS


Teens and caregivers enrolled in the school-based asthma care for teen's trial in Rochester, NY completed in-home surveys. We classified ready teens as those reporting a score of five on both items of the transition readiness assessment questionnaire talking with providers subscale. We performed bivariate analyses to detect differences between ready teens and other teens in teen- and caregiver-reported responsibility, teen medication beliefs, and clinical outcomes (medication adherence over the past 2 weeks, and healthcare use over the past year).
RESULTS


Among this sample of 251 adolescents (mean age: 13.4 years), 35% were classified as ""Ready."" Ready teens were more likely than other teens to want to use a controller medication independently (7.6 vs. 6.5 out of 10, p < .01) and to have confidence in this ability (8.4 vs. 7.6 out of 10, p = .02). Teens reported poor adherence (missed 52.9% of prescribed controller doses), with no differences in responsibility or clinical outcomes based on level of teen readiness for talking with providers.
CONCLUSIONS


In urban adolescents with poorly controlled asthma, a higher level of teen readiness for talking with providers is associated with higher perceptions of independence in medication taking, but does not appear to relate to clinical outcomes.",2019,"In urban adolescents with poorly controlled asthma, a higher level of teen readiness for talking with providers is associated with higher perceptions of independence in medication taking, but does not appear to relate to clinical outcomes.","['Urban Youth With Asthma', ""Teens and caregivers enrolled in the school-based asthma care for teen's trial in Rochester, NY completed in-home surveys"", 'caregivers to teens', 'urban adolescents with poorly controlled asthma', '251 adolescents (mean age: 13.4 years), 35% were classified as ""Ready', 'urban adolescents with asthma']",[],['poor adherence'],"[{'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1318955', 'cui_str': 'Asthma management'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517558', 'cui_str': '13.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]",[],"[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",251.0,0.0208373,"In urban adolescents with poorly controlled asthma, a higher level of teen readiness for talking with providers is associated with higher perceptions of independence in medication taking, but does not appear to relate to clinical outcomes.","[{'ForeName': 'Marybeth R', 'Initials': 'MR', 'LastName': 'Jones', 'Affiliation': 'University of Rochester Medical Center, Division of General Pediatrics, Rochester, New York. Electronic address: Marybeth_Jones@URMC.Rochester.edu.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Frey', 'Affiliation': 'University of Rochester Medical Center, Division of General Pediatrics, Rochester, New York.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Riekert', 'Affiliation': 'Johns Hopkins School of Medicine, Division of Pulmonary and Critical Care Medicine, Baltimore, Maryland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Fagnano', 'Affiliation': 'University of Rochester Medical Center, Division of General Pediatrics, Rochester, New York.'}, {'ForeName': 'Jill S', 'Initials': 'JS', 'LastName': 'Halterman', 'Affiliation': 'University of Rochester Medical Center, Division of General Pediatrics, Rochester, New York.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2018.08.026']
2605,30521423,Ventilatory responses to acute hypoxia and hypercapnia in humans with a patent foramen ovale.,"Subjects with a patent foramen ovale (PFO) have blunted ventilatory acclimatization to high altitude compared with subjects without PFO. The blunted response observed could be because of differences in central and/or peripheral respiratory chemoreflexes. We hypothesized that compared with subjects without a PFO (PFO-), subjects with a PFO (PFO+) would have blunted ventilatory responses to acute hypoxia and hypercapnia. Sixteen PFO+ subjects (9 female) and 15 PFO- subjects (8 female) completed four 20-min trials on the same day: 1) normoxic hypercapnia (NH), 2) hyperoxic hypercapnia (HH), 3) isocapnic hypoxia (IH), and 4) poikilocapnic hypoxia (PH). Hypercapnic trials were completed before the hypoxic trials, the order of the hypercapnic (NH & HH) and hypoxic (IH & PH) trials were randomized, and trials were separated by ≥40 min. During the NH trials but not the HH trials subjects who were PFO+ had a blunted hypercapnic ventilatory response compared with subjects who were PFO- (1.41 ± 0.46 l·min -1 ·mmHg -1  vs. 1.98 ± 0.71 l·min -1 ·mmHg -1 , P = 0.02). There were no differences between the PFO+ and PFO- subjects with respect to the acute hypoxic ventilatory response during IH and PH trials. Hypoxic ventilatory depression was similar between subjects who were PFO+ and PFO- during IH. These data suggest that compared with subjects who were PFO-, subjects who were PFO+ have normal ventilatory chemosensitivity to acute hypoxia but blunted ventilatory chemosensitivity to carbon dioxide, possibly because of reduced carbon dioxide sensitivity of either the central and/or the peripheral chemoreceptors. NEW & NOTEWORTHY Patent foramen ovale (PFO) is found in ~25%-40% of the population. The presence of a PFO appears to be associated with blunted ventilatory responses during acute exposure to normoxic hypercapnia. The reason for this blunted ventilatory response during acute exposure to normoxic hypercapnia is unknown but may suggest differences in either central and/or peripheral chemoreflex contribution to hypercapnia.",2019,There were no differences between the PFO+ and PFO- subjects with respect to the acute hypoxic ventilatory response during IH and PH trials.,"['Subjects with a patent foramen ovale (PFO', 'subjects without a PFO (PFO-), subjects with a PFO (PFO', 'Sixteen PFO+ subjects (9 female) and 15 PFO- subjects (8 female) completed four 20-min trials on the same day: 1', 'humans with a patent foramen ovale', 'Patent foramen ovale (PFO']","['normoxic hypercapnia (NH), 2) hyperoxic hypercapnia (HH), 3) isocapnic hypoxia (IH), and 4) poikilocapnic hypoxia (PH']","['acute hypoxic ventilatory response', 'Hypoxic ventilatory depression', 'carbon dioxide sensitivity', 'blunted hypercapnic ventilatory response']","[{'cui': 'C0016522', 'cui_str': 'Patent foramen ovale'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}]",16.0,0.0491374,There were no differences between the PFO+ and PFO- subjects with respect to the acute hypoxic ventilatory response during IH and PH trials.,"[{'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'Davis', 'Affiliation': 'Indiana State University, Department of Kinesiology, Recreation, and Sport, Terre Haute, Indiana.'}, {'ForeName': 'Lindsey M', 'Initials': 'LM', 'LastName': 'Boulet', 'Affiliation': 'University of British Columbia, Centre for Heart, Lung, and Vascular Health, School of Health and Exercise Science , Kelowna, BC , Canada.'}, {'ForeName': 'Alyssa M', 'Initials': 'AM', 'LastName': 'Hardin', 'Affiliation': 'University of Oregon, Department of Human Physiology , Eugene, Oregon.'}, {'ForeName': 'Alex J', 'Initials': 'AJ', 'LastName': 'Chang', 'Affiliation': 'University of Oregon, Department of Human Physiology , Eugene, Oregon.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Lovering', 'Affiliation': 'University of Oregon, Department of Human Physiology , Eugene, Oregon.'}, {'ForeName': 'Glen E', 'Initials': 'GE', 'LastName': 'Foster', 'Affiliation': 'University of British Columbia, Centre for Heart, Lung, and Vascular Health, School of Health and Exercise Science , Kelowna, BC , Canada.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00741.2018']
2606,31899823,Association between immunosuppressive cytokines and PSA progression in biochemically recurrent prostate cancer treated with intermittent hormonal therapy.,"BACKGROUND


Immunosuppressive cytokines have the potential to promote prostate cancer progression. Assessing their longitudinal changes may implicate mechanisms of progression, treatment resistance, and suggest new therapeutic targets.
METHODS


Thirty-seven men with biochemically recurrent (BCR) prostate cancer who received 6 months of androgen deprivation therapy (ADT) and were monitored until the time to prostate-specific antigen progression (TTPP) were identified from a completed phase III trial (NCT00020085). Serum samples were archived at baseline, 3 months after ADT, and at TTPP. Cytokine concentrations were quantified using a 36-parameter electrochemiluminescence assay. The Wilcoxon signed-rank sum test was used to compare observations between time points. Kaplan-Meier analysis was used to calculate TTPP dichotomized by cytokine values above or below the median. Pearson's rank correlation coefficient was used to compare continuous variables.
RESULTS


Median TTPP was 399 days (range, 114-1641). Median prostate-specific antigen (PSA) at baseline and progression were 8.5 and 5.3 ng/mL, respectively. Twenty-three patients (62%) achieved undetectable PSA with ADT. Castrate levels of testosterone (<50 ng/dL) after 3 months of ADT occurred in 35 patients (95%). TNF-α (P = .002), IL-23 (P = .002), and CXCL10 (P = .001) significantly increased from baseline to post ADT. Certain cytokines correlated longitudinally: TNF-α correlated with IL-23 (r = .72; P < .001) and IL-8 (r = .59; P < .001) from baseline to post ADT and to PSA progression. Neutrophil-to-lymphocyte ratio correlated with IL-27 (r = .57; P < .001) and MIP-3α (r = .56; P < .001). Patients with a detectable PSA after ADT had elevated levels of IL-6 (P = .049) and IL-8 (P = .013) at PSA progression as compared with those with an undetectable PSA. There was a trend toward shorter TTPP in patients with TNF-α levels above the median (P = .042).
CONCLUSIONS


Several innate cytokines were associated with biochemically recurrent prostate cancer.",2020,Patients with a detectable PSA after ADT had elevated levels of IL-6 (P = .049) and IL-8,['Thirty-seven men with biochemically recurrent (BCR) prostate cancer who received 6 months of'],"['intermittent hormonal therapy', 'androgen deprivation therapy (ADT']","['IL-23', 'TNF-α', 'IL-8', 'elevated levels of IL-6', 'CXCL10', 'MIP-3α', 'Cytokine concentrations', 'time to prostate-specific antigen progression (TTPP', 'Neutrophil-to-lymphocyte ratio', 'Median prostate-specific antigen (PSA', 'Castrate levels of testosterone']","[{'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}]","[{'cui': 'C0963088', 'cui_str': 'IL-23'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1308752', 'cui_str': 'CXCL10 protein, human'}, {'cui': 'C0376579', 'cui_str': 'Macrophage Inflammatory Proteins'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}]",37.0,0.0700291,Patients with a detectable PSA after ADT had elevated levels of IL-6 (P = .049) and IL-8,"[{'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Hawley', 'Affiliation': 'Division of Hematology and Oncology, Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Pan', 'Affiliation': 'Division of Hematology and Oncology, Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Figg', 'Affiliation': 'Molecular Pharmacology Section, Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Zoila A', 'Initials': 'ZA', 'LastName': 'Lopez-Bujanda', 'Affiliation': 'Columbia Center for Translational Immunology, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Strope', 'Affiliation': 'Molecular Pharmacology Section, Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Aggen', 'Affiliation': 'Division of Hematology and Oncology, Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Dallos', 'Affiliation': 'Division of Hematology and Oncology, Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Emerson A', 'Initials': 'EA', 'LastName': 'Lim', 'Affiliation': 'Division of Hematology and Oncology, Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Mark N', 'Initials': 'MN', 'LastName': 'Stein', 'Affiliation': 'Division of Hematology and Oncology, Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Division of Hematology and Oncology, Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Drake', 'Affiliation': 'Division of Hematology and Oncology, Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York, New York.'}]",The Prostate,['10.1002/pros.23948']
2607,32142518,Playing with fire. Understanding how experiencing a fire in an immersive virtual environment affects prevention behavior.,"A potentially effective way to influence people's fire prevention behavior is letting them experience a fire in an immersive virtual environment (IVE). We analyze the effects of experiencing a fire in an IVE (versus an information sheet) on psychological determinants of behavior-knowledge, vulnerability, severity, self-efficacy, and locus of control-based mainly on arguments from Protection Motivation Theory and the Health Belief Model. Crucial in our setup is that we also relate these determinants to actual prevention behavior. Results show that IVE has the hypothesized effects on vulnerability, severity, and self-efficacy, and an unexpected negative effect on knowledge. Only knowledge and vulnerability showed subsequent indirect effects on actual prevention behavior. There remains a direct positive effect of IVE on prevention behavior that cannot be explained by any of the determinants. Our results contradict the implicit assumption that an induced change in these psychological determinants by IVE, necessarily implies a change in behavior. A recommendation for research on the effects of IVE's is, whenever possible, to study the actual target behavior as well.",2020,Only knowledge and vulnerability showed subsequent indirect effects on actual prevention behavior.,[],['IVE'],"['vulnerability, severity, and self-efficacy', 'psychological determinants of behavior-knowledge, vulnerability, severity, self-efficacy']",[],"[{'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0139951,Only knowledge and vulnerability showed subsequent indirect effects on actual prevention behavior.,"[{'ForeName': 'Patty C P', 'Initials': 'PCP', 'LastName': 'Jansen', 'Affiliation': 'Department of Marketing Intelligence, Division Interpolis, Achmea Holding B.V., Tilburg, The Netherlands.'}, {'ForeName': 'Chris C P', 'Initials': 'CCP', 'LastName': 'Snijders', 'Affiliation': 'Department of Human Technology Interaction, Eindhoven University of Technology, Eindhoven, The Netherlands.'}, {'ForeName': 'Martijn C', 'Initials': 'MC', 'LastName': 'Willemsen', 'Affiliation': 'Department of Human Technology Interaction, Eindhoven University of Technology, Eindhoven, The Netherlands.'}]",PloS one,['10.1371/journal.pone.0229197']
2608,32546065,Prehabilitation in patients awaiting elective coronary artery bypass graft surgery - effects on functional capacity and quality of life: a randomized controlled trial.,"OBJECTIVE


To determine the impact of an exercise-based prehabilitation (EBPrehab) program on pre- and postoperative exercise capacity, functional capacity (FC) and quality of life (QoL) in patients awaiting elective coronary artery bypass graft surgery (CABG).
DESIGN


A two-group randomized controlled trail.
SETTING


Ambulatory prehabilitation.
SUBJECTS


Overall 230 preoperative elective CABG-surgery patients were randomly assigned to an intervention (IG,  n  = 88;  n  = 27 withdrew after randomization) or control group (CG,  n  = 115).
INTERVENTION


IG: two-week EBPrehab including supervised aerobic exercise. CG: usual care.
MAIN MEASURES


At baseline (T1), one day before surgery (T2), at the beginning (T3) and at the end of cardiac rehabilitation (T4) the following measurements were performed: cardiopulmonary exercise test, six-minute walk test (6MWT), Timed-Up-and-Go Test (TUG) and QoL (MacNew questionnaire).
RESULTS


A total of 171 patients (IG,  n  = 81; CG,  n  = 90) completed the study. During EBPrehab no complications occurred. Preoperatively FC (6MWT IG : 443.0 ± 80.1 m to 493.5 ± 75.5 m,  P  = 0.003; TUG IG : 6.9 ± 2.0 s to 6.1 ± 1.8 s,  P  = 0.018) and QoL (IG: 5.1 ± 0.9 to 5.4 ± 0.9,  P  < 0.001) improved significantly more in IG compared to CG. Similar effects were observed postoperatively in FC (6MWD IG : Δ-64.7 m, p T1-T3 =  0.013; Δ+47.2 m, p T1-T4 <  0.001; TUG IG : Δ+1.4 s, p T1-T3 =  0.003).
CONCLUSIONS


A short-term EBPrehab is effective to improve perioperative FC and preoperative QoL in patients with stable coronary artery disease awaiting CABG-surgery. ID: NCT04111744 ( www.ClinicalTrials.gov ;  Preoperative Exercise Training for Patients Undergoing Coronary Artery Bypass Graft Surgery- A Prospective Randomized Trial ).",2020,"Similar effects were observed postoperatively in FC (6MWD IG : Δ-64.7 m, p T1-T3 =  0.013; Δ+47.2 m, p T1-T4 <  0.001; TUG IG : Δ+1.4 s, p T1-T3 =  0.003).
","['Overall 230 preoperative elective CABG-surgery patients', 'patients awaiting elective coronary artery bypass graft surgery - effects', '171 patients (IG,  n \u2009=\u200981; CG,  n \u2009=\u200990) completed the study', 'Patients Undergoing Coronary Artery Bypass Graft', 'Ambulatory prehabilitation', 'patients awaiting elective coronary artery bypass graft surgery (CABG', 'patients with stable coronary artery disease awaiting CABG-surgery']","['intervention (IG,  n \u2009=\u200988;  n \u2009=\u200927 withdrew after randomization) or control group (CG,  n \u2009=\u2009115', 'EBPrehab including supervised aerobic exercise', 'ID', 'Preoperative Exercise Training', 'Surgery', 'exercise-based prehabilitation (EBPrehab) program']","['pre- and postoperative exercise capacity, functional capacity (FC) and quality of life (QoL', 'functional capacity and quality of life', 'perioperative FC and preoperative QoL', 'cardiopulmonary exercise test, six-minute walk test (6MWT), Timed-Up-and-Go Test (TUG) and QoL (MacNew questionnaire']","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C5192101', 'cui_str': 'Prehabilitation'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C5192101', 'cui_str': 'Prehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",230.0,0.110256,"Similar effects were observed postoperatively in FC (6MWD IG : Δ-64.7 m, p T1-T3 =  0.013; Δ+47.2 m, p T1-T4 <  0.001; TUG IG : Δ+1.4 s, p T1-T3 =  0.003).
","[{'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Steinmetz', 'Affiliation': 'Institute of Sport Science, Department of Training Science and Kinesiology, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'Birna', 'Initials': 'B', 'LastName': 'Bjarnason-Wehrens', 'Affiliation': 'Institute of Cardiology and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Baumgarten', 'Affiliation': 'Kerckhoff Heart Center, Department of Cardiothoracic Surgery, Bad Nauheim, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Walther', 'Affiliation': 'Department of Cardiothoracic Surgery, University of Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mengden', 'Affiliation': 'Kerckhoff Heart Center, Department of Rehabilitation, Bad Nauheim, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Walther', 'Affiliation': 'Department of Cardiology, University of Frankfurt, Frankfurt am Main, Germany.'}]",Clinical rehabilitation,['10.1177/0269215520933950']
2609,32546105,Effects of wheelchair Tai Chi ball exercise on physical and mental health and functional abilities among elderly with physical disability.,"The purpose of this study was to examine the effect of a 12-week Wheelchair Tai Chi Ball (WTCB) intervention, a combination of mind-body exercise with strength training, on physical and mental health and functional abilities among elderly with disability. Twenty-six elderly persons participated in the study, nine WTCB group participants and ten control group participants completed the study. The WTCB group practised WTCB12 twice/week for one hour each time. The control group did their daily routine without WTCB intervention. The outcomes measures were: Pain Self-Efficacy Questionnaire (PSEQ), SF-36v2 for physical and mental health, heart rate, blood pressure, range of motion and muscle strength of the dominant arm at the shoulder, elbow and wrist joints. The Mixed Model ANOVA was employed to examine the differences between and within the two groups using pre-test and post-test scores. The results demonstrated the WTCB group had significant improvements on PSEQ, general physical health and had positive effects on maintaining muscle strength at the shoulder, elbow and wrist joints as compared to the control group. The WTCB12 exercise had positive effects on self-efficacy for pain management, general physical health, and maintain upper extremity muscle strength and is a feasible exercise for elderly with disability.",2020,"The WTCB12 exercise had positive effects on self-efficacy for pain management, general physical health, and maintain upper extremity muscle strength and is a feasible exercise for elderly with disability.","['Twenty-six elderly persons participated in the study, nine WTCB group participants and ten control group participants completed the study', 'elderly with physical disability', 'elderly with disability']","['WTCB', 'Wheelchair Tai Chi Ball (WTCB) intervention, a combination of mind-body exercise with strength training', 'wheelchair Tai Chi ball exercise', 'daily routine without WTCB intervention', 'WTCB12 exercise']","['PSEQ, general physical health', 'physical and mental health and functional abilities', 'Pain Self-Efficacy Questionnaire (PSEQ), SF-36v2 for physical and mental health, heart rate, blood pressure, range of motion and muscle strength of the dominant arm at the shoulder, elbow and wrist joints', 'maintaining muscle strength at the shoulder, elbow and wrist joints']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043143', 'cui_str': 'Wheelchair'}, {'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]","[{'cui': 'C0043143', 'cui_str': 'Wheelchair'}, {'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C4075347', 'cui_str': 'Pain Self-efficacy Questionnaire'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C1322271', 'cui_str': 'Wrist joint structure'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",26.0,0.0239731,"The WTCB12 exercise had positive effects on self-efficacy for pain management, general physical health, and maintain upper extremity muscle strength and is a feasible exercise for elderly with disability.","[{'ForeName': 'Yong Tai', 'Initials': 'YT', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, University of Texas at Tyler , Tyler, United States.'}, {'ForeName': 'Chung-Hyun', 'Initials': 'CH', 'LastName': 'Goh', 'Affiliation': 'Department of Mechanical Engineering, University of Texas at Tyler , Tyler, United States.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Liao', 'Affiliation': 'Wuhan Sports University , Wuhan, China.'}, {'ForeName': 'Xuanliang Neil', 'Initials': 'XN', 'LastName': 'Dong', 'Affiliation': 'Department of Health and Kinesiology, University of Texas at Tyler , Tyler, United States.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Duke', 'Affiliation': 'School of Nursing, University of Texas at Tyler , Tyler, United States.'}, {'ForeName': 'Danita', 'Initials': 'D', 'LastName': 'Alfred', 'Affiliation': 'School of Nursing, University of Texas at Tyler , Tyler, United States.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Wuhan Sports University , Wuhan, China.'}, {'ForeName': 'Jingle', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'School of Nursing, University of Texas at Tyler , Tyler, United States.'}, {'ForeName': 'Shiqi', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Department of Health and Kinesiology, University of Texas at Tyler , Tyler, United States.'}]",Research in sports medicine (Print),['10.1080/15438627.2020.1777553']
2610,32546125,Erythropoietin as candidate for supportive treatment of severe COVID-19.,"In light of the present therapeutic situation in COVID-19, any measure to improve course and outcome of seriously affected individuals is of utmost importance. We recap here evidence that supports the use of human recombinant erythropoietin (EPO) for ameliorating course and outcome of seriously ill COVID-19 patients. This brief expert review grounds on available subject-relevant literature searched until May 14, 2020, including Medline, Google Scholar, and preprint servers. We delineate in brief sections, each introduced by a summary of respective COVID-19 references, how EPO may target a number of the gravest sequelae of these patients. EPO is expected to: (1) improve respiration at several levels including lung, brainstem, spinal cord and respiratory muscles; (2) counteract overshooting inflammation caused by cytokine storm/ inflammasome; (3) act neuroprotective and neuroregenerative in brain and peripheral nervous system. Based on this accumulating experimental and clinical evidence, we finally provide the research design for a double-blind placebo-controlled randomized clinical trial including severely affected patients, which is planned to start shortly.",2020,"In light of the present therapeutic situation in COVID-19, any measure to improve course and outcome of seriously affected individuals is of utmost importance.",['seriously ill COVID-19 patients'],"['human recombinant erythropoietin (EPO', 'Erythropoietin', 'EPO', 'placebo']",[],"[{'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0997797,"In light of the present therapeutic situation in COVID-19, any measure to improve course and outcome of seriously affected individuals is of utmost importance.","[{'ForeName': 'Hannelore', 'Initials': 'H', 'LastName': 'Ehrenreich', 'Affiliation': 'Clinical Neuroscience, Max Planck Institute of Experimental Medicine, Göttingen, Germany. ehrenreich@em.mpg.de.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Weissenborn', 'Affiliation': 'Department of Neurology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Begemann', 'Affiliation': 'Clinical Neuroscience, Max Planck Institute of Experimental Medicine, Göttingen, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Busch', 'Affiliation': 'Center of Internal Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Vieta', 'Affiliation': 'Institute of Neuroscience, University of Barcelona, IDIBAPS, CIBERSAM, Barcelona, Spain.'}, {'ForeName': 'Kamilla W', 'Initials': 'KW', 'LastName': 'Miskowiak', 'Affiliation': 'Psychiatric Centre Copenhagen, University Hospital, Rigshospitalet, Copenhagen, Denmark. Kamilla.miskowiak@regionh.dk.'}]","Molecular medicine (Cambridge, Mass.)",['10.1186/s10020-020-00186-y']
2611,32546128,Videolaryngoscopy versus direct laryngoscopy for double-lumen endotracheal tube intubation in thoracic surgery - a randomised controlled clinical trial.,"BACKGROUND


Double-lumen tube (DLT) intubation is necessary for thoracic surgery and other operations with the need for lung separation. However, DLT insertion is complex and might result in airway trauma. A new videolaryngoscopy (GVL) with a thin blade might improve the intubation time and reduce complexity as well as iatrogenic airway complications compared to conventional direct laryngoscopy (DL) for DLT intubation.
METHODS


A randomised, controlled trial was conducted in 70 patients undergoing elective thoracic surgery using DLT for lung separation. Primary endpoint was time to successful intubation. The secondary endpoints of this study were number of intubation attempts, the assessment of difficulty, any complications during DLT intubation and the incidence of objective trauma of the oropharynx and supraglottic space and intubation-related subjective symptoms.
RESULTS


65 patients were included (DL group [n  =  31], GVL group [n  =  34]). Median intubation time (25th-75th percentiles) in GVL group was 93 s (63-160) versus 74 (58-94) in DL group [p = 0.044]. GVL resulted in significantly improved visualisation of the larynx (Cormack and Lehane grade of 1 in GVL group was 97% vs. 74% in DL Group [p = 0.008]). Endoscopic examinations revealed significant differences in GVL group compared to DL group showing less red-blooded vocal cord [p = 0.004], vocal cord haematoma [p = 0.022] and vocal cord haemorrhage [p = 0.002]. No significant differences regarding the postoperative subjective symptoms of airway were found.
CONCLUSIONS


Videolaryngoscopy using the GlideScope®-Titanium shortly prolongs DLT intubation duration compared to direct laryngoscopy but improves the view. Objective intubation trauma but not subjective complaints are reduced.
TRIAL REGISTRATION


German Clinical Trial Register DRKS00020978, retrospectively registered on 09. March 2020.",2020,"Endoscopic examinations revealed significant differences in GVL group compared to DL group showing less red-blooded vocal cord [p = 0.004], vocal cord haematoma [p = 0.022] and vocal cord haemorrhage [p = 0.002].","['70 patients undergoing elective thoracic surgery using DLT for lung separation', '65 patients were included (DL group [n\u200a\u2009=\u2009\u200a31], GVL group [n\u200a\u2009=\u2009\u200a34']","['conventional direct laryngoscopy (DL', 'Double-lumen tube (DLT) intubation', 'Videolaryngoscopy versus direct laryngoscopy for double-lumen endotracheal tube intubation', 'videolaryngoscopy (GVL', 'GVL']","['postoperative subjective symptoms of airway', 'number of intubation attempts, the assessment of difficulty, any complications during DLT intubation and the incidence of objective trauma of the oropharynx and supraglottic space and intubation-related subjective symptoms', 'vocal cord haematoma', 'Median intubation time', 'DLT intubation duration', 'time to successful intubation', 'visualisation of the larynx (Cormack and Lehane grade', 'vocal cord haemorrhage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}, {'cui': 'C0441299', 'cui_str': 'Double lumen tube'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0036679', 'cui_str': 'Separation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392823', 'cui_str': 'Direct laryngoscopy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0600554', 'cui_str': 'Graft-vs-Leukemia Effect'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0392823', 'cui_str': 'Direct laryngoscopy'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C2584423', 'cui_str': 'Double lumen tracheobronchial tube'}, {'cui': 'C0600554', 'cui_str': 'Graft-vs-Leukemia Effect'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0441299', 'cui_str': 'Double lumen tube'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0225574', 'cui_str': 'Structure of supraglottic space'}, {'cui': 'C0344369', 'cui_str': 'Vocal cord hematoma'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0023051', 'cui_str': 'Disorder of the larynx'}, {'cui': 'C0456719', 'cui_str': 'Cormack and Lehane grade'}]",70.0,0.326676,"Endoscopic examinations revealed significant differences in GVL group compared to DL group showing less red-blooded vocal cord [p = 0.004], vocal cord haematoma [p = 0.022] and vocal cord haemorrhage [p = 0.002].","[{'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Risse', 'Affiliation': 'Center of Emergency Medicine, University Hospital Essen, Hufelandstrasse 55, 45122, Essen, Germany. joachim.risse@uk-essen.de.'}, {'ForeName': 'Ann-Kristin', 'Initials': 'AK', 'LastName': 'Schubert', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Philipps-University Marburg, Baldingerstraße, 35033, Marburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wiesmann', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Philipps-University Marburg, Baldingerstraße, 35033, Marburg, Germany.'}, {'ForeName': 'Ansgar', 'Initials': 'A', 'LastName': 'Huelshoff', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Philipps-University Marburg, Baldingerstraße, 35033, Marburg, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Stay', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Philipps-University Marburg, Baldingerstraße, 35033, Marburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zentgraf', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Philipps-University Marburg, Baldingerstraße, 35033, Marburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kirschbaum', 'Affiliation': 'Visceral, Thoracic and Vascular Surgery Clinic, University Hospital Giessen and Marburg GmbH, Baldingerstraße, 35033, Marburg, Germany.'}, {'ForeName': 'Hinnerk', 'Initials': 'H', 'LastName': 'Wulf', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Philipps-University Marburg, Baldingerstraße, 35033, Marburg, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Feldmann', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Philipps-University Marburg, Baldingerstraße, 35033, Marburg, Germany.'}, {'ForeName': 'Karl Matteo', 'Initials': 'KM', 'LastName': 'Meggiolaro', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Philipps-University Marburg, Baldingerstraße, 35033, Marburg, Germany.'}]",BMC anesthesiology,['10.1186/s12871-020-01067-x']
2612,32546155,Creatine kinase elevation after robotic surgery for rectal cancer due to a prolonged lithotomy position.,"BACKGROUND


Robotic surgery for rectal cancer, which is now performed worldwide, can be associated with elevated creatine kinase levels postoperatively. In this study, we compared postoperative complications between patients undergoing robotic surgery and laparoscopic surgery.
METHODS


We identified 66 consecutive patients who underwent curative resection for rectal cancer at Juntendo University Hospital between January 2016 and February 2019. Patients were divided into a conventional laparoscopic surgery (CLS) group (n = 38) and a robotic-assisted laparoscopic surgery (RALS) group (n = 28) before comparing various clinicodemographic factors between the groups.
RESULTS


Patient age and gender, surgical approach (CLS/RALS), pathological T factor, pathological stage, duration of postoperative hospital stay, and postoperative complications were not significantly different between the RALS and CLS groups. However, the operation time was significantly longer in the RALS group (407 min) than in the CLS group (295 min; p < 0.001). Notably, the serum level of creatine kinase on postoperative day 1 was significantly higher in the CLS group (154 IU/L) than in the RALS group (525 IU/L; p < 0.001), despite there being no significant differences in the incidence of rhabdomyolysis. The multivariate analysis showed that RALS/CLS (HR 6.0 95% CI 1.3-27.5, p = 0.02) and operation time (HR 15.9 95% CI 3.79-67.4, p = 0.001) remained independent factors of CK elevation on postoperative day 1.
CONCLUSIONS


Clinically relevant positioning injuries and rhabdomyolysis may occur in patients who are subjected to a prolonged and extreme Trendelenburg position or who have extra force applied to the abdominal wall because of remote center displacement. The creatine kinase value should therefore be measured after RALS to monitor for the sequelae of these potential positioning injuries.",2020,"However, the operation time was significantly longer in the RALS group (407 min) than in the CLS group (295 min; p < 0.001).","['66 consecutive patients who underwent curative resection for rectal cancer at Juntendo University Hospital between January 2016 and February 2019', 'patients undergoing robotic surgery and laparoscopic surgery']","['CLS', 'robotic-assisted laparoscopic surgery (RALS', 'RALS', 'conventional laparoscopic surgery (CLS']","['serum level of creatine kinase on postoperative day 1', 'pathological T factor, pathological stage, duration of postoperative hospital stay, and postoperative complications', 'incidence of rhabdomyolysis', 'postoperative complications', 'Creatine kinase elevation', 'operation time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035410', 'cui_str': 'Rhabdomyolysis'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.148619,"However, the operation time was significantly longer in the RALS group (407 min) than in the CLS group (295 min; p < 0.001).","[{'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Tsuchiya', 'Affiliation': 'Department of Coloproctological Surgery, Juntendo University Faculty of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Munakata', 'Affiliation': 'Department of Coloproctological Surgery, Juntendo University Faculty of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan. smunaka@juntendo.ac.jp.'}, {'ForeName': 'Ryoichi', 'Initials': 'R', 'LastName': 'Tsukamoto', 'Affiliation': 'Department of Coloproctological Surgery, Juntendo University Faculty of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Okazawa', 'Affiliation': 'Department of Coloproctological Surgery, Juntendo University Faculty of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Mizukoshi', 'Affiliation': 'Department of Coloproctological Surgery, Juntendo University Faculty of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan.'}, {'ForeName': 'Kiichi', 'Initials': 'K', 'LastName': 'Sugimoto', 'Affiliation': 'Department of Coloproctological Surgery, Juntendo University Faculty of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Department of Coloproctological Surgery, Juntendo University Faculty of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan.'}, {'ForeName': 'Yutaka Kojima Yuichi', 'Initials': 'YKY', 'LastName': 'Tomiki', 'Affiliation': 'Department of Coloproctological Surgery, Juntendo University Faculty of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Coloproctological Surgery, Juntendo University Faculty of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan.'}]",BMC surgery,['10.1186/s12893-020-00771-2']
2613,32546177,Implementation of a nurse-led self-management support intervention for patients with cancer-related pain: a cluster randomized phase-IV study with a stepped wedge design (EvANtiPain).,"BACKGROUND


Pain self-management support interventions were effective in controlled clinical trials and meta analyses. However, implementation of these complex interventions may not translate into identical effects. This paper evaluates the implementation of ANtiPain, a cancer pain self-management support intervention in routine clinical practice according to the Reach Efficacy-Adoption Implementation Maintenance framework.
METHODS


In this cluster randomized study with a stepped wedge design, N = 153 adult patients with cancer-related pain were recruited from 01/17 to 05/18 on 17 wards of 3 hospitals in Vienna, Austria. ANtiPain entailed a face-to-face in-hospital session by a trained nurse to prepare discharge according to key strategies, information on pain self-management, and skills building. After discharge, cancer-pain self-management was coached via phone calls. Patient-level data were collected at recruitment, and 2, 4 and 8 weeks after discharge via postal or online questionnaire. Primary outcome was pain interference with daily activities. Secondary outcomes included pain intensity, self-efficacy, and patient satisfaction. Organizational-level data (e.g., on implementation procedures) were collected by study or intervention nurses. The mixed model to analyze patient-level data included a random intercept and a random slope for individual and a random intercept for ward.
RESULTS


Recruitment was slower than expected and unevenly distributed over wards and hospitals. The face-to-face session was clinically feasible (mean duration = 33 min) as well as the mean amount (n = 2) and duration of phone calls (mean = 17 min). Only 16 (46%) of 35 trained nurses performed the intervention on nine wards. To deal with the loss of power, analyses were adapted. Overall effects on pain interference were not significant. However, effects were significant in sub analyses of the nine wards that recruited patients in the intervention period (p = .009). Regarding secondary outcomes, the group-by-time effect was significant for self-efficacy (p = .033), and patient satisfaction with information on pain-self-management (p = .002) and in-hospital pain management (p = .018).
CONCLUSIONS


The implementation of ANtiPain improved meaningful patient outcomes on wards that applied the intervention routinely. Our analyses showed that the implementation benefited from being embedded in larger scale projects to improve cancer pain management and that the selection of wards with a high percentage of oncology patients may be crucial.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02891785 Date of registration: September 8, 2016.",2020,"Regarding secondary outcomes, the group-by-time effect was significant for self-efficacy (p = .033), and patient satisfaction with information on pain-self-management (p = .002) and in-hospital pain management (p = .018).
","['153 adult patients with cancer-related pain were recruited from 01/17 to 05/18 on 17 wards of 3 hospitals in Vienna, Austria', 'patients with cancer-related pain']","['nurse-led self-management support intervention', 'stepped wedge design (EvANtiPain']","['hospital pain management', 'pain interference with daily activities', 'patient satisfaction with information on pain-self-management', 'pain intensity, self-efficacy, and patient satisfaction', 'self-efficacy', 'pain interference']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0004348', 'cui_str': 'Austria'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439639', 'cui_str': 'Wedge'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",153.0,0.0615578,"Regarding secondary outcomes, the group-by-time effect was significant for self-efficacy (p = .033), and patient satisfaction with information on pain-self-management (p = .002) and in-hospital pain management (p = .018).
","[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Raphaelis', 'Affiliation': 'Department of Nursing Science, University of Vienna, Alser Strasse 23/12, 1080, Vienna, Austria.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Frommlet', 'Affiliation': 'Center for Medical Statistics, Informatics and Intelligent Systems (Institute of Medical Statistics), Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Mayer', 'Affiliation': 'Department of Nursing Science, University of Vienna, Alser Strasse 23/12, 1080, Vienna, Austria.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Koller', 'Affiliation': 'Department of Nursing Science, University of Vienna, Alser Strasse 23/12, 1080, Vienna, Austria. antje.koller@univie.ac.at.'}]",BMC cancer,['10.1186/s12885-020-06729-0']
2614,32546180,Two-by-two factorial randomised study within a trial (SWAT) to evaluate strategies for follow-up in a randomised prevention trial.,"BACKGROUND


Failure to collect outcome data in randomised trials can result in bias and loss of statistical power. Further evaluations of strategies to increase retention are required. We assessed the effectiveness of two strategies for retention in a randomised prevention trial using a two-by-two factorial randomised study within a trial (SWAT).
METHODS


Parents of babies included in the host trial were randomised to (1) short message service (SMS) notification prior to sending questionnaires at 3, 6, 12 and 18 months versus no SMS notification and (2) a £10 voucher sent with the invitation letter for the primary follow-up visit at 24 months or given at the visit. The two co-primary outcomes were collection of host trial (1) questionnaire data at interim follow-up times and (2) primary outcome at 24 months during a home/clinic visit with a research nurse.
RESULTS


Between November 2014 and November 2016, 1394 participants were randomised: 350 to no SMS + voucher at visit, 345 to SMS + voucher at visit, 352 to no SMS + voucher before visit and 347 to SMS + voucher before visit. Overall questionnaire data was collected at interim follow-up times for 75% in both the group allocated to the prior SMS notification and the group allocated to no SMS notification (odds ratio (OR) SMS versus none 1.02, 95% CI 0.83 to 1.25). Host trial primary outcome data was collected at a visit for 557 (80%) allocated to the voucher before the visit in the invitation letter and for 566 (81%) whose parents were allocated to receive the voucher at the visit (OR before versus at visit 0.89, 95% CI 0.69 to 1.17).
CONCLUSION


There was no evidence of a difference in retention according to SMS notification or voucher timing. Future synthesis of SWAT results is required to be able to detect small but important incremental effects of retention strategies.
TRIAL REGISTRATION


ISRCTN registry, ID: ISRCTN21528841. Registered on 25 July 2014. SWAT Repository Store ID 25.",2020,"Overall questionnaire data was collected at interim follow-up times for 75% in both the group allocated to the prior SMS notification and the group allocated to no SMS notification (odds ratio (OR) SMS versus none 1.02, 95% CI 0.83 to 1.25).","['Between November 2014 and November 2016', '1394 participants were randomised: 350 to', 'Parents of babies included in the host trial were randomised to (1']","['short message service (SMS) notification prior to sending questionnaires at 3, 6, 12 and 18\u2009months versus no SMS notification and (2) a £10 voucher sent with the invitation letter', 'no SMS\u2009+\u2009voucher at visit, 345 to SMS\u2009+\u2009voucher at visit, 352 to no SMS\u2009+\u2009voucher before visit and 347 to SMS\u2009+\u2009voucher before visit']","['Overall questionnaire data', 'collection of host trial (1) questionnaire data at interim follow-up times and (2) primary outcome at 24\u2009months during a home/clinic visit with a research nurse']","[{'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0422202', 'cui_str': 'Notifications'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0687693', 'cui_str': 'Research nurse'}]",1394.0,0.242976,"Overall questionnaire data was collected at interim follow-up times for 75% in both the group allocated to the prior SMS notification and the group allocated to no SMS notification (odds ratio (OR) SMS versus none 1.02, 95% CI 0.83 to 1.25).","[{'ForeName': 'Lucy E', 'Initials': 'LE', 'LastName': 'Bradshaw', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, NG7 2RD, UK. lucy.bradshaw@nottingham.ac.uk.'}, {'ForeName': 'Alan A', 'Initials': 'AA', 'LastName': 'Montgomery', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, NG7 2RD, UK.'}, {'ForeName': 'Hywel C', 'Initials': 'HC', 'LastName': 'Williams', 'Affiliation': 'Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, NG7 2NR, UK.'}, {'ForeName': 'Joanne R', 'Initials': 'JR', 'LastName': 'Chalmers', 'Affiliation': 'Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, NG7 2NR, UK.'}, {'ForeName': 'Rachel H', 'Initials': 'RH', 'LastName': 'Haines', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, NG7 2RD, UK.'}]",Trials,['10.1186/s13063-020-04373-4']
2615,32546187,Correction to: Effectiveness of a multi-level intervention to reduce men's perpetration of intimate partner violence: a cluster randomised controlled trial.,An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,"[""men's perpetration of intimate partner violence""]",['multi-level intervention'],[],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0718428,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Nicola J', 'Initials': 'NJ', 'LastName': 'Christofides', 'Affiliation': 'Faculty of Health Sciences, School of Public Health, University of the Witwatersrand, 27 St Andrews Rd, Parktown, Johannesburg, 2193, South Africa. nicola.christofides@wits.ac.za.'}, {'ForeName': 'Abigail M', 'Initials': 'AM', 'LastName': 'Hatcher', 'Affiliation': 'Faculty of Health Sciences, School of Public Health, University of the Witwatersrand, 27 St Andrews Rd, Parktown, Johannesburg, 2193, South Africa.'}, {'ForeName': 'Dumisani', 'Initials': 'D', 'LastName': 'Rebombo', 'Affiliation': 'Sonke Gender Justice, Juta Street, Braamfontein, Johannesburg, South Africa.'}, {'ForeName': 'Ruari-Santiago', 'Initials': 'RS', 'LastName': 'McBride', 'Affiliation': 'Faculty of Health Sciences, School of Public Health, University of the Witwatersrand, 27 St Andrews Rd, Parktown, Johannesburg, 2193, South Africa.'}, {'ForeName': 'Shehnaz', 'Initials': 'S', 'LastName': 'Munshi', 'Affiliation': 'Faculty of Health Sciences, School of Public Health, University of the Witwatersrand, 27 St Andrews Rd, Parktown, Johannesburg, 2193, South Africa.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Pino', 'Affiliation': 'Sonke Gender Justice, Juta Street, Braamfontein, Johannesburg, South Africa.'}, {'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'Abdelatif', 'Affiliation': 'South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Peacock', 'Affiliation': 'Sonke Gender Justice, Juta Street, Braamfontein, Johannesburg, South Africa.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Levin', 'Affiliation': 'Faculty of Health Sciences, School of Public Health, University of the Witwatersrand, 27 St Andrews Rd, Parktown, Johannesburg, 2193, South Africa.'}, {'ForeName': 'Rachel K', 'Initials': 'RK', 'LastName': 'Jewkes', 'Affiliation': 'Faculty of Health Sciences, School of Public Health, University of the Witwatersrand, 27 St Andrews Rd, Parktown, Johannesburg, 2193, South Africa.'}]",Trials,['10.1186/s13063-020-04386-z']
2616,32546220,Correction to: Evaluating the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in severely ill adults with COVID-19: A structured summary of a study protocol for a randomized controlled trial.,An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,['severely ill adults with COVID-19'],['human anti-SARS-CoV-2 convalescent plasma'],['efficacy and safety'],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0823071,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Eckhardt', 'Affiliation': 'Columbia University Medical Center, New York, USA. cme2113@cumc.columbia.edu.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Cummings', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Kartik N', 'Initials': 'KN', 'LastName': 'Rajagopalan', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Borden', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Zachary C', 'Initials': 'ZC', 'LastName': 'Bitan', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Wolf', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kantor', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Briese', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Meyer', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Samuel D', 'Initials': 'SD', 'LastName': 'Jacobson', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Scotto', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Nischay', 'Initials': 'N', 'LastName': 'Mishra', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Neena M', 'Initials': 'NM', 'LastName': 'Philip', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Brie A', 'Initials': 'BA', 'LastName': 'Stotler', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Schwartz', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Shaz', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Spitalnik', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Eisenberger', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Eldad A', 'Initials': 'EA', 'LastName': 'Hod', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Justman', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Cheung', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'W Ian', 'Initials': 'WI', 'LastName': 'Lipkin', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Max R', 'Initials': 'MR', 'LastName': ""O'Donnell"", 'Affiliation': 'Columbia University Medical Center, New York, USA.'}]",Trials,['10.1186/s13063-020-04504-x']
2617,32546239,A prospective longitudinal study on the microbiota composition in amyotrophic lateral sclerosis.,"BACKGROUND


A connection between amyotrophic lateral sclerosis (ALS) and altered gut microbiota composition has previously been reported in animal models. This work is the first prospective longitudinal study addressing the microbiota composition in ALS patients and the impact of a probiotic supplementation on the gut microbiota and disease progression.
METHODS


Fifty patients and 50 matched controls were enrolled. The microbial profile of stool samples from patients and controls was analyzed via PCR-Denaturing Gradient Gel Electrophoresis, and the main microbial groups quantified via qPCR. The whole microbiota was then analyzed via next generation sequencing after amplification of the V3-V4 region of 16S rDNA. Patients were then randomized to receive probiotic treatment or placebo and followed up for 6 months with ALSFRS-R, BMI, and FVC%.
RESULTS


The results demonstrate that the gut microbiota of ALS patients is characterized by some differences with respect to controls, regardless of the disability degree. Moreover, the gut microbiota composition changes during the course of the disease as demonstrated by the significant decrease in the number of observed operational taxonomic unit during the follow-up. Interestingly, an unbalance between potentially protective microbial groups, such as Bacteroidetes, and other with potential neurotoxic or pro-inflammatory activity, such as Cyanobacteria, has been shown. The 6-month probiotic treatment influenced the gut microbial composition; however, it did not bring the biodiversity of intestinal microbiota of patients closer to that of control subjects and no influence on the progression of the disease measured by ALSFRS-R was demonstrated.
CONCLUSIONS


Our study poses the bases for larger clinical studies to characterize the microbiota changes as a novel ALS biomarker and to test new microbial strategy to ameliorate the health status of the gut.
TRIAL REGISTRATION


CE 107/14, approved by the Ethics Committee of the ""Maggiore della Carità"" University Hospital, Italy.",2020,"The 6-month probiotic treatment influenced the gut microbial composition; however, it did not bring the biodiversity of intestinal microbiota of patients closer to that of control subjects and no influence on the progression of the disease measured by ALSFRS-R was demonstrated.
","['Fifty patients and 50 matched controls were enrolled', 'amyotrophic lateral sclerosis', 'ALS patients']","['probiotic supplementation', 'probiotic treatment or placebo']","['gut microbial composition', 'gut microbiota composition changes', 'biodiversity of intestinal microbiota']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002736', 'cui_str': 'Amyotrophic lateral sclerosis'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0282469', 'cui_str': 'Biological Diversity'}]",50.0,0.0171276,"The 6-month probiotic treatment influenced the gut microbial composition; however, it did not bring the biodiversity of intestinal microbiota of patients closer to that of control subjects and no influence on the progression of the disease measured by ALSFRS-R was demonstrated.
","[{'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Di Gioia', 'Affiliation': 'Department of Agricultural and Food Sciences, University of Bologna, Viale Fanin 42, Bologna, Italy.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Bozzi Cionci', 'Affiliation': 'Department of Agricultural and Food Sciences, University of Bologna, Viale Fanin 42, Bologna, Italy.'}, {'ForeName': 'Loredana', 'Initials': 'L', 'LastName': 'Baffoni', 'Affiliation': 'Department of Agricultural and Food Sciences, University of Bologna, Viale Fanin 42, Bologna, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Amoruso', 'Affiliation': 'BIOLAB RESEARCH srl, via E. Mattei 3, 28100, Novara, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pane', 'Affiliation': 'BIOLAB RESEARCH srl, via E. Mattei 3, 28100, Novara, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Mogna', 'Affiliation': 'BIOLAB RESEARCH srl, via E. Mattei 3, 28100, Novara, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Gaggìa', 'Affiliation': 'Department of Agricultural and Food Sciences, University of Bologna, Viale Fanin 42, Bologna, Italy.'}, {'ForeName': 'Maria Ausiliatrice', 'Initials': 'MA', 'LastName': 'Lucenti', 'Affiliation': 'Department of Neurology and ALS Centre, University of Piemonte Orientale, Maggiore della Carità Hospital, Corso Mazzini 18, 28100, Novara, Italy.'}, {'ForeName': 'Enrica', 'Initials': 'E', 'LastName': 'Bersano', 'Affiliation': 'Department of Neurology and ALS Centre, University of Piemonte Orientale, Maggiore della Carità Hospital, Corso Mazzini 18, 28100, Novara, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Cantello', 'Affiliation': 'Department of Neurology and ALS Centre, University of Piemonte Orientale, Maggiore della Carità Hospital, Corso Mazzini 18, 28100, Novara, Italy.'}, {'ForeName': 'Fabiola', 'Initials': 'F', 'LastName': 'De Marchi', 'Affiliation': 'Department of Neurology and ALS Centre, University of Piemonte Orientale, Maggiore della Carità Hospital, Corso Mazzini 18, 28100, Novara, Italy.'}, {'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Mazzini', 'Affiliation': 'Department of Neurology and ALS Centre, University of Piemonte Orientale, Maggiore della Carità Hospital, Corso Mazzini 18, 28100, Novara, Italy. letizia.mazzini@uniupo.it.'}]",BMC medicine,['10.1186/s12916-020-01607-9']
2618,32546240,Diabetes conversation map - a novel tool for diabetes management self-efficacy among type 2 diabetes patients in Pakistan: a randomized controlled trial.,"BACKGROUND


This study aimed to measure the effect of diabetes education using the novel method of ""diabetes conversation map (DCM)"" as compared to routine counselling (RC) on diabetes management self-efficacy (DMSE) among patients living with type 2 diabetes in Karachi, Pakistan.
METHODS


A parallel arm randomized controlled trial among patients with type 2 diabetes aged 30-60 years, with HbA1c > 7%, diagnosed for at least 5 yrs., was conducted at the national institute of diabetes and endocrinology in Karachi, Pakistan. A total 123 type 2 diabetes patients were randomized into DCM (n = 62) or RC (n = 61). Four weekly diabetes control sessions of 40 min each using the DCM or RC was provided. DMSE was measured using a validated Urdu language DMSE tool at baseline and after three months of the randomization. Change in DMSE and HbA1c levels within groups (pre-post) and between the groups after 3 months of enrollment was compared.
RESULTS


Baseline characteristics except HbA1c were similar between the two arms. After 3 months of enrollment, there was no change in the DMSE score in the RC arm however, significant increase in DMSE score was noted in the DCM arm (P = < 0.001). The average difference (95% confidence interval) in DMSE score between the DCM and RC arm was 33.7(27.3, 40.0; p = < 0.001) after 3 months of the enrollment. Difference in HbA1c within groups was not significant.
CONCLUSIONS


DCM significantly improved DMSE among type 2 diabetes patients in a developing country setting like Pakistan. Healthcare workers caring for type 2 diabetes patients need to be trained on DCM to effectively utilize this novel tool for educating diabetes patients.
TRIAL REGISTRATION


This trial was prospectively registered. ClinicalTrials.gov Identifier: NCT03747471. Date of registration: Nov 20. 2018.",2020,"The average difference (95% confidence interval) in DMSE score between the DCM and RC arm was 33.7(27.3, 40.0; p = < 0.001) after 3 months of the enrollment.","['type 2 diabetes patients in Pakistan', 'patients living with type 2 diabetes in Karachi, Pakistan', 'Healthcare workers caring for type 2 diabetes patients', 'patients with type 2 diabetes aged 30-60\u2009years, with HbA1c\u2009>\u20097%, diagnosed for at least 5\u2009yrs., was conducted at the national institute of diabetes and endocrinology in Karachi, Pakistan', 'A total 123 type 2 diabetes patients']","['DCM', 'routine counselling (RC', 'Diabetes conversation map - a novel tool', 'diabetes conversation map (DCM']","['DMSE score', 'Change in DMSE and HbA1c levels', 'DMSE']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0014137', 'cui_str': 'Endocrinology'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.170351,"The average difference (95% confidence interval) in DMSE score between the DCM and RC arm was 33.7(27.3, 40.0; p = < 0.001) after 3 months of the enrollment.","[{'ForeName': 'Rubina', 'Initials': 'R', 'LastName': 'Qasim', 'Affiliation': 'Dow University of Health Sciences, Karachi, Pakistan. Qasim.ruby@gmail.com.'}, {'ForeName': 'Sarfaraz', 'Initials': 'S', 'LastName': 'Masih', 'Affiliation': 'Dow University of Health Sciences, Karachi, Pakistan.'}, {'ForeName': 'Mohammad Tahir', 'Initials': 'MT', 'LastName': 'Yousafzai', 'Affiliation': 'Department of Pediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Hakim', 'Initials': 'H', 'LastName': 'Shah', 'Affiliation': 'Indus college of Allied Health, The Indus Hospital, Karachi, Pakistan.'}, {'ForeName': 'Abdul', 'Initials': 'A', 'LastName': 'Manan', 'Affiliation': 'Patel Hospital and Institute of Nursing, Karachi, Pakistan.'}, {'ForeName': 'Yousaf', 'Initials': 'Y', 'LastName': 'Shah', 'Affiliation': 'Dow University of Health Sciences, Karachi, Pakistan.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Yaqoob', 'Affiliation': 'Dow University of Health Sciences, Karachi, Pakistan.'}, {'ForeName': 'Abida', 'Initials': 'A', 'LastName': 'Razzaq', 'Affiliation': 'Liaquat National Hospital College of Nursing, Karachi, Pakistan.'}, {'ForeName': 'Ajmal', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Dow University of Health Sciences, Karachi, Pakistan.'}, {'ForeName': 'Atiya Rahman Khan', 'Initials': 'ARK', 'LastName': 'Rohilla', 'Affiliation': 'Indus college of Allied Health, The Indus Hospital, Karachi, Pakistan.'}]",BMC endocrine disorders,['10.1186/s12902-020-00572-x']
2619,32546242,Failure of anti Interleukin-1 β monoclonal antibody in the treatment of recurrent pericarditis in two children.,"BACKGROUND


Recurrent pericarditis (RP) is a complication (15-30%) of acute pericarditis with an unknown etiology. Treatment regimen consists of a combination of non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine, with the addition of corticosteroids in resistant or intolerant cases. In the last decade anakinra was shown as an effective treatment in patients with colchicine resistant and steroid-dependent RP, initially in anecdotal reports in children and more recently in a randomized trial. Canakinumab is a monoclonal antibody selectively blocking IL-1β and its use is only anecdotally reported to treat pericarditis. We report two pediatric patients with refractory recurrent pericarditis, who presented an optimal response to anakinra treatment but prompt relapse after switch to canakinumab.
CASE PRESENTATION


The first patient is a girl with Recurrent Pericarditis started in April 2015, after heart surgery. NSAIDs and oral steroids were started, with prompt relapse after steroid suspension. The child showed a steroid-dependent RP; anakinra was therefore started with excellent response, but discontinued after 2 weeks for local reactions. In July 2016 therapy with canakinumab was started. She experienced four relapses during canakinumab therapy despite dosage increase and steroid treatment. In January 2018 a procedure of desensitization from anakinra was performed, successfully. Anakinra as monotherapy is currently ongoing, without any sign of flare. The second patient is a girl with an idiopathic RP, who showed an initial benefit from NSAIDs and colchicine. However, 10 days after the first episode a relapse occurred and therapy with anakinra was established. Two months later, while being in complete remission, anakinra was replaced with canakinumab due to patient's poor compliance to daily injections. She experienced a relapse requiring steroids 10 days after the first canakinumab injection. Anakinra was subsequently re-started with complete remission, persisting after 24 months follow-up.
CONCLUSIONS


We describe two cases of failure of the treatment with anti-IL-1β monoclonal antibodies in steroid- dependent idiopathic RP. This anecdotal and preliminary observation suggests a different efficacy of the two IL-1 blockers in the management of RP and support a possible pivotal role of IL-1α in the pathogenesis of this condition.",2020,This anecdotal and preliminary observation suggests a different efficacy of the two IL-1 blockers in the management of RP and support a possible pivotal role of IL-1α in the pathogenesis of this condition.,"['recurrent pericarditis in two children', 'pediatric patients with refractory recurrent pericarditis, who presented an optimal response to anakinra treatment but prompt relapse after switch to canakinumab', 'patients with colchicine resistant and steroid-dependent RP']","['combination of non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine', 'colchicine']",[],"[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0031046', 'cui_str': 'Pericarditis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}]","[{'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0009262', 'cui_str': 'Colchicine'}]",[],2.0,0.0177211,This anecdotal and preliminary observation suggests a different efficacy of the two IL-1 blockers in the management of RP and support a possible pivotal role of IL-1α in the pathogenesis of this condition.,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Signa', 'Affiliation': 'UOSD Centro Malattie Autoinfiammatorie ed Immunodeficienze, IRCCS Istituto Giannina Gaslini, Via Gerolamo Gaslini 5, 16147, Genoa, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': ""D'Alessandro"", 'Affiliation': 'UOSD Centro Malattie Autoinfiammatorie ed Immunodeficienze, IRCCS Istituto Giannina Gaslini, Via Gerolamo Gaslini 5, 16147, Genoa, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Consolini', 'Affiliation': 'Clinica pediatrica, Università di Pisa, Pisa, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Miniaci', 'Affiliation': 'Pediatric Unit, Department of Medical and Surgical Sciences, S. Orsola Hospital, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Bustaffa', 'Affiliation': 'UOSD Centro Malattie Autoinfiammatorie ed Immunodeficienze, IRCCS Istituto Giannina Gaslini, Via Gerolamo Gaslini 5, 16147, Genoa, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Longo', 'Affiliation': 'UOSD Centro Malattie Autoinfiammatorie ed Immunodeficienze, IRCCS Istituto Giannina Gaslini, Via Gerolamo Gaslini 5, 16147, Genoa, Italy.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Tosca', 'Affiliation': 'UOSD Centro Allergologia IRCCS Istituto Giannina Gaslini, Genoa, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Bizzi', 'Affiliation': 'Clinica pediatrica, Università di Pisa, Pisa, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Caorsi', 'Affiliation': 'UOSD Centro Malattie Autoinfiammatorie ed Immunodeficienze, IRCCS Istituto Giannina Gaslini, Via Gerolamo Gaslini 5, 16147, Genoa, Italy.'}, {'ForeName': 'Leonardo Oliveira', 'Initials': 'LO', 'LastName': 'Mendonça', 'Affiliation': 'UOSD Centro Malattie Autoinfiammatorie ed Immunodeficienze, IRCCS Istituto Giannina Gaslini, Via Gerolamo Gaslini 5, 16147, Genoa, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Pession', 'Affiliation': 'Pediatric Unit, Department of Medical and Surgical Sciences, S. Orsola Hospital, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Ravelli', 'Affiliation': 'DINOGMI, Università di Genova, Genoa, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Gattorno', 'Affiliation': 'UOSD Centro Malattie Autoinfiammatorie ed Immunodeficienze, IRCCS Istituto Giannina Gaslini, Via Gerolamo Gaslini 5, 16147, Genoa, Italy. marcogattorno@gaslini.org.'}]",Pediatric rheumatology online journal,['10.1186/s12969-020-00438-5']
2620,32546247,"Health-related quality of life of children and their parents 2 years after critical illness: pre-planned follow-up of the PEPaNIC international, randomized, controlled trial.","BACKGROUND


Pediatric intensive care unit (PICU) survivors are at risk for prolonged morbidities interfering with daily life. The current study examined parent-reported health-related quality of life (HRQoL) in former critically ill children and parents themselves and aimed to determine whether withholding parenteral nutrition (PN) in the first week of critical illness affected children's and parents' HRQoL 2 years later.
METHODS


Children who participated in the pediatric early versus late parenteral nutrition in critical illness (PEPaNIC) trial and who were testable 2 years later (n = 1158) were included. Their HRQoL outcomes were compared with 405 matched healthy controls. At PICU admission, children had been randomly assigned to early-PN or late-PN. In the early-PN group, PN was initiated within 24 h after PICU admission. In the late-PN group, PN was withheld for up to 1 week in the PICU. Parents completed the Infant Toddler Quality of Life Questionnaire (ITQOL; age 2-3 years) or the Child Health Questionnaire-Parent Form 50 (CHQ-PF50; age 4-18 years). Besides, they completed the Health Utility Index (HUI) and the Short Form Health Survey (SF-12) regarding their child's and their own HRQoL, respectively.
RESULTS


For the total age group of 786 post-PICU survivors, parents reported lower scores for almost all HRQoL scales compared to healthy children. Age-specifically, younger critically ill children (2.5 to 3 years old) scored worse for growth and development and older children (4-18 years old) scored worse for role functioning and mental health. Parents' own mental and physical HRQoL was comparable to that of healthy control parents. No HRQoL differences were found between children in the late-PN and those in the early-PN group.
CONCLUSIONS


Parent-reported HRQoL of children 2 years after critical illness was impaired compared with healthy controls. In relation to their child's HRQoL, parents reported impairments in emotions, personal time, and family activities; however, their own HRQoL was not impaired. Withholding PN in the first week during critical illness had no impact on longer-term HRQoL of the child.
TRIAL REGISTRATION


Clinical trials, NCT01536275. Registered 22 February 2012.",2020,"For the total age group of 786 post-PICU survivors, parents reported lower scores for almost all HRQoL scales compared to healthy children.","['younger critically ill children (2.5 to 3\u2009years old) scored worse for growth and development and older children (4-18\u2009years old) scored worse for role functioning and mental health', 'Pediatric intensive care unit (PICU) survivors', 'Children who participated in the pediatric early versus late parenteral nutrition in critical illness (PEPaNIC) trial and who were testable 2\u2009years later (n\u2009=\u20091158) were included']",['withholding parenteral nutrition (PN'],"['emotions, personal time, and family activities', 'Infant Toddler Quality of Life Questionnaire (ITQOL; age 2-3\u2009years) or the Child Health Questionnaire', 'HRQoL scales', 'Health Utility Index (HUI']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",405.0,0.151047,"For the total age group of 786 post-PICU survivors, parents reported lower scores for almost all HRQoL scales compared to healthy children.","[{'ForeName': 'José', 'Initials': 'J', 'LastName': 'Hordijk', 'Affiliation': ""Intensive Care Unit, Department of Pediatrics and Pediatric Surgery, Erasmus Medical Centre-Sophia Children's Hospital, Dr. Molewaterplein 60, 3015, GJ, Rotterdam, The Netherlands.""}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Verbruggen', 'Affiliation': ""Intensive Care Unit, Department of Pediatrics and Pediatric Surgery, Erasmus Medical Centre-Sophia Children's Hospital, Dr. Molewaterplein 60, 3015, GJ, Rotterdam, The Netherlands.""}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Vanhorebeek', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Herestraat 49, 3000, Leuven, Belgium.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Güiza', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Herestraat 49, 3000, Leuven, Belgium.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Wouters', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Herestraat 49, 3000, Leuven, Belgium.'}, {'ForeName': 'Greet', 'Initials': 'G', 'LastName': 'Van den Berghe', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Herestraat 49, 3000, Leuven, Belgium.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Joosten', 'Affiliation': ""Intensive Care Unit, Department of Pediatrics and Pediatric Surgery, Erasmus Medical Centre-Sophia Children's Hospital, Dr. Molewaterplein 60, 3015, GJ, Rotterdam, The Netherlands.""}, {'ForeName': 'Karolijn', 'Initials': 'K', 'LastName': 'Dulfer', 'Affiliation': ""Intensive Care Unit, Department of Pediatrics and Pediatric Surgery, Erasmus Medical Centre-Sophia Children's Hospital, Dr. Molewaterplein 60, 3015, GJ, Rotterdam, The Netherlands. k.dulfer@erasmusmc.nl.""}]","Critical care (London, England)",['10.1186/s13054-020-03059-2']
2621,32543886,Aromatherapy for test anxiety in chiropractic students:  A feasibility study .,"OBJECTIVE


Up to 85% of college students experience test anxiety, which may contribute to decreased academic performance. The purpose of this study was to assess the feasibility of recruiting chiropractic students for a randomized trial involving aromatherapy for anxiety reduction.
METHODS


This study enrolled chiropractic students who were randomly assigned to separate rooms during a biochemistry test. Waterless diffusers dispersed a lemon and rosemary blend of essential oils in the experimental room and water in the control room. Students completed pretest surveys rating current and general anxiety. Posttest surveys included rating current anxiety. Analysis of covariance (ANCOVA) was preformed to determine within- and between-group differences for current anxiety. Feasibility was the primary aim, and the statistical significance of anxiety test scores between rooms was the secondary aim.
RESULTS


Sixty-four students were included in the study. The feasibility of research methods was noted for adherence to the study protocol (informed consent, randomization, and survey distribution and completion) and resource allocation. Design improvements are required in recruitment methods, follow-up surveys, and intervention blinding. ANCOVA for between-group comparisons showed no statistically significant difference between groups' pre- and posttest anxiety scores ( p =  .22). Two reported side effects, eye and sinus irritation, could not be attributed to treatment group. Most students were willing to use aromatherapy for test anxiety in the future.
CONCLUSION


We demonstrated feasibility in conducting a randomized study to measure the influence of aromatherapy on test anxiety in chiropractic students. A powered, randomized study is needed to determine if aromatherapy may be effective in reducing test anxiety.",2020,ANCOVA for between-group comparisons showed no statistically significant difference between groups' pre- and posttest anxiety scores ( p =  .22).,"['enrolled chiropractic students', 'Sixty-four students were included in the study', 'chiropractic students']","['aromatherapy', 'Aromatherapy']","['side effects, eye and sinus irritation', 'pretest surveys rating current and general anxiety', 'pre- and posttest anxiety scores', 'rating current anxiety', 'anxiety test scores']","[{'cui': 'C0008138', 'cui_str': 'Chiropractic'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0376547', 'cui_str': 'Aromatherapy'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0441723', 'cui_str': 'Irritation'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",64.0,0.0554359,ANCOVA for between-group comparisons showed no statistically significant difference between groups' pre- and posttest anxiety scores ( p =  .22).,"[{'ForeName': 'Breanne M', 'Initials': 'BM', 'LastName': 'Wells', 'Affiliation': ''}, {'ForeName': 'Lia M', 'Initials': 'LM', 'LastName': 'Nightingale', 'Affiliation': ''}, {'ForeName': 'Dustin C', 'Initials': 'DC', 'LastName': 'Derby', 'Affiliation': ''}, {'ForeName': 'Stacie A', 'Initials': 'SA', 'LastName': 'Salsbury', 'Affiliation': ''}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Lawrence', 'Affiliation': ''}]",The Journal of chiropractic education,['10.7899/JCE-18-36']
2622,32543929,Effects of a workplace physical activity intervention on cognitive determinants of physical activity: a randomized controlled trial.,"Objective:  The present randomized controlled trial evaluated if a workplace physical activity (PA) program that comprises both a PA component and a psychological coaching component (PA + C) is more effective in changing cognitive determinants of PA than a PA program without coaching component.  Design:   N  = 213 employees were cluster-randomly assigned to two groups: the PA + C group received the MoVo-work intervention, combining a psychological coaching component and a PA component. The PA group received the PA component without psychological coaching.  Main Outcome Measures:  Strength of goal intention, self-efficacy, outcome expectations, action planning and barrier management were assessed at five time points (before and at the end of the intervention, as well as 6 weeks, 6 months and 12 months after the intervention).  Results:  After six weeks and one year, respectively, the PA + C group showed significantly higher goal intentions ( p  = .018) and self-efficacy beliefs ( p  = .006) than the PA group; and, at a descriptive level, a clear tendency towards better barrier management.  Conclusions:  The results indicate that a workplace PA program, including psychological coaching, may partially improve the effects of a pure PA program on critical motivational and volitional determinants of PA behavioural change among employees.",2020,"After six weeks and one year, respectively, the PA + C group showed significantly higher goal intentions ( p  = .018) and self-efficacy beliefs ( p  = .006) than the PA group; and, at a descriptive level, a clear tendency towards better barrier management.  ",['N \u2009=\u2009213 employees'],"['pure PA program', 'workplace physical activity (PA) program that comprises both a PA component and a psychological coaching component (PA\u2009+\u2009C', 'workplace physical activity intervention', 'PA component without psychological coaching', 'MoVo-work intervention, combining a psychological coaching component and a PA component', 'PA\u2009']","['Strength of goal intention, self-efficacy, outcome expectations, action planning and barrier management', 'goal intentions', 'cognitive determinants of physical activity', 'self-efficacy beliefs']","[{'cui': 'C0599987', 'cui_str': 'Employee'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",213.0,0.0222938,"After six weeks and one year, respectively, the PA + C group showed significantly higher goal intentions ( p  = .018) and self-efficacy beliefs ( p  = .006) than the PA group; and, at a descriptive level, a clear tendency towards better barrier management.  ","[{'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Krebs', 'Affiliation': 'Department of Sport Science, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Wurst', 'Affiliation': 'Department of Sport Science, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Wiebke', 'Initials': 'W', 'LastName': 'Göhner', 'Affiliation': 'Health Psychology, Catholic University of Applied Sciences, Freiburg, Germany.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Fuchs', 'Affiliation': 'Department of Sport Science, University of Freiburg, Freiburg, Germany.'}]",Psychology & health,['10.1080/08870446.2020.1780233']
2623,32543979,Participant experiences of change in mindfulness-based stress reduction for anxiety disorders.,"AIM


To explore experiences of change among participants in a randomized clinical trial of mindfulness-based stress reduction (MBSR) for anxiety disorders.
METHOD


Semi-structured interviews were conducted to explore the subjective experiences of change for individuals with anxiety disorders after a course in MBSR. Interviews were analysed employing hermeneutic-phenomenological thematic analysis.
RESULTS


Five main themes were identified: 1) Something useful to do when anxiety appears, 2) Feeling more at ease, 3) Doing things my anxiety wouldn't let me, 4) Meeting what is there, and 5) Better-but not there yet. Most participants used what they had learned for instrumental purposes, and described relief from anxiety and an increased sense of personal agency. A few reported more radical acceptance of anxiety, as well as increased self-compassion.
CONCLUSION


Participants of MBSR both describe mindfulness as a tool to ""fix"" anxiety and as bringing about more fundamental change towards acceptance of their anxiety. The complexity of reported change corresponds with better handling of areas representing known transdiagnostic features of anxiety disorder, such as dysfunctional cognitive processes (including attentional biases), emotional dysregulation, avoidance behaviours, and maladaptive self-relatedness. This supports MBSR as a transdiagnostic approach to the treatment of anxiety disorders.",2020,"Participants of MBSR both describe mindfulness as a tool to ""fix"" anxiety and as bringing about more fundamental change towards acceptance of their anxiety.","['Five main themes were identified', 'Semi-structured interviews', 'individuals with anxiety disorders after a course in MBSR']",['mindfulness-based stress reduction (MBSR'],['radical acceptance of anxiety'],"[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0275636,"Participants of MBSR both describe mindfulness as a tool to ""fix"" anxiety and as bringing about more fundamental change towards acceptance of their anxiety.","[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Schanche', 'Affiliation': 'Department of Clinical Psychology, University of Bergen , Bergen, Norway.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Vøllestad', 'Affiliation': 'Department of Clinical Psychology, University of Bergen , Bergen, Norway.'}, {'ForeName': 'Per-Einar', 'Initials': 'PE', 'LastName': 'Binder', 'Affiliation': 'Department of Clinical Psychology, University of Bergen , Bergen, Norway.'}, {'ForeName': 'Aslak', 'Initials': 'A', 'LastName': 'Hjeltnes', 'Affiliation': 'Department of Clinical Psychology, University of Bergen , Bergen, Norway.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Dundas', 'Affiliation': 'Department of Clinical Psychology, University of Bergen , Bergen, Norway.'}, {'ForeName': 'Geir Høstmark', 'Initials': 'GH', 'LastName': 'Nielsen', 'Affiliation': 'Department of Clinical Psychology, University of Bergen , Bergen, Norway.'}]",International journal of qualitative studies on health and well-being,['10.1080/17482631.2020.1776094']
2624,32543980,"Intralesional cryotherapy versus Cryotherapy spray for the treatment of recalcitrant plantar warts: a prospective, randomized study.","Back ground:  Recalcitrant planter warts are representing a therapeutic challenge. Intralesional cryotherapy (ILC) has emerged as a promising therapeutic option in recalcitrant planter warts treatment. Objective:  To compare the clinical efficacy, safety and tolerability of (ILC) versus Cryotherapy spray (Cryo-sp) for treatment of recalcitrant plantar warts. Methods:  One hundred-thirty patients with recalcitrant plantar warts were assigned equally to two groups. Group A received ILC and group B treated with Cryo-SP. Both groups received one session at 2 weeks intervals until complete clearance or for a maximum of 5 sessions. Main outcome was complete clearance of the warts guided by dermoscopy. Follow-up was carried out for 6 months after the treatment. Results:  Complete clearance occurred in 80.3% in group A compared to 50.8% in group B with a highly significant difference between both groups (P < 0.001). The clearance rate was faster in group A (1.5 ± 0.40) than group B (4 ± 1.3) (p < 0.001). The adverse effects were mild in group A than group B (P < 0.001). The recurrence rate was 2% in group A versus 23.3% in group B (P < 0.007).patients satisfaction was higher in ILC (P < 0.001). Conclusion:  Intralesional cryotherapy is more effective, requiring few sessions with low recurrence rate than cryo-sp.",2020,The recurrence rate was 2% in group A versus 23.3% in group B (P < 0.007).patients satisfaction was higher in ILC (P < 0.001).,"['recalcitrant plantar warts', 'One hundred-thirty patients with recalcitrant plantar warts']","['Cryotherapy spray (Cryo-sp', 'Cryo-SP', 'Intralesional cryotherapy', 'Intralesional cryotherapy versus Cryotherapy spray', 'ILC', 'Intralesional cryotherapy (ILC']","['complete clearance of the warts guided by dermoscopy', 'Complete clearance', 'clinical efficacy, safety and tolerability', 'clearance rate', 'adverse effects', 'recurrence rate']","[{'cui': 'C0042548', 'cui_str': 'Verruca plantaris'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C1512955', 'cui_str': 'Intralesional route'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0043037', 'cui_str': 'Verruca'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1449565', 'cui_str': 'Dermatoscopy'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",130.0,0.0471096,The recurrence rate was 2% in group A versus 23.3% in group B (P < 0.007).patients satisfaction was higher in ILC (P < 0.001).,"[{'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Albalat', 'Affiliation': 'Dermatology, Venereology and Andrology Department, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Enayat', 'Initials': 'E', 'LastName': 'Attwa', 'Affiliation': 'Dermatology, Venereology and Andrology Department, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Howyda Mohamed', 'Initials': 'HM', 'LastName': 'Ebrahim', 'Affiliation': 'Dermatology, Venereology and Andrology Department, Faculty of Medicine, Zagazig University, Egypt.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1782821']
2625,32557838,The Motor skills At Playtime intervention improves children's locomotor skills: A feasibility study.,"BACKGROUND


Interventions are needed to teach fundamental motor skills (FMS) to preschoolers. There is a need to design more practical and effective interventions that can be successfully implemented by non-motor experts and fit within the existing gross motor opportunities such as outdoor free play at the preschool. The purpose of this study was to evaluate the feasibility and efficacy of a non-motor expert FMS intervention that was implemented during outdoor free play, Motor skills At Playtime (MAP).
METHODS


Participants were preschoolers from two Head Start Centers (N = 46; M age  = 4.7 ± 0.46 years; 41% boys) and were divided into a MAP (n = 30) or control (outdoor free play; n = 16) group. Children completed either a 1350-minute MAP intervention or control condition (outdoor free play) from January to April of 2018. FMS were assessed before and after each program. using both the Test of Gross Motor Development-3 rd  Edition (Ulrich, 2019) and skill outcome measures (running speed, hopping speed, jump distance, throwing speed, kicking speed, and catching percentage). Intervention implementation feasibility was measures through daily fidelity checks. Fidelity was evaluated as the percentage of intervention sessions that included all explicit intervention criteria. FMS data were analyzed using linear mixed modeling. Models were fit with fixed effects of time and treatment, covariates of sex and height, and a random intercept for each individual.
RESULTS


The non-motor expert was feasibly able to implement MAP with high fidelity (> 93%). There was a significant treatment effect for MAP on process and product locomotor FMS (p< 0.05), and a trend for a treatment effect for MAP on total process FMS (p = 0.07).
CONCLUSION


Results support that MAP was successfully implemented by a non-motor expert and led to improvements in children's FMS, especially locomotor FMS.",2020,"There was a significant treatment effect for MAP on process and product locomotor FMS (p< 0.05), and a trend for a treatment effect for MAP on total process FMS (p = 0.07).
",['Participants were preschoolers from two Head Start Centers (N = 46; M age  = 4.7 ± 0.46 years; 41% boys) and were divided into a MAP (n = 30) or control (outdoor free play; n = 16) group'],"['non-motor expert FMS intervention', '1350-minute MAP intervention or control condition (outdoor free play', 'Playtime intervention']","['outdoor free play, Motor skills', ""children's locomotor skills"", 'MAP on process and product locomotor FMS', 'Gross Motor Development-3 rd  Edition (Ulrich, 2019) and skill outcome measures (running speed, hopping speed, jump distance, throwing speed, kicking speed, and catching percentage', 'feasibility and efficacy', 'FMS', 'Motor skills']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517460', 'cui_str': '0.46'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517567', 'cui_str': '1350'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0032214', 'cui_str': 'Play'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0231617', 'cui_str': 'Catch'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0124364,"There was a significant treatment effect for MAP on process and product locomotor FMS (p< 0.05), and a trend for a treatment effect for MAP on total process FMS (p = 0.07).
","[{'ForeName': 'Kara K', 'Initials': 'KK', 'LastName': 'Palmer', 'Affiliation': 'School of Kinesiology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Alison L', 'Initials': 'AL', 'LastName': 'Miller', 'Affiliation': 'School of Public Health, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Sean K', 'Initials': 'SK', 'LastName': 'Meehan', 'Affiliation': 'Department of Kinesiology, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Leah E', 'Initials': 'LE', 'LastName': 'Robinson', 'Affiliation': 'School of Kinesiology, University of Michigan, Ann Arbor, MI, USA.'}]","Child: care, health and development",['10.1111/cch.12793']
2626,32557843,Residual Symptoms of Posttraumatic Stress Disorder and Alcohol Use Disorder Following Integrated Exposure Treatment Versus Coping Skills Treatment.,"Although some studies have demonstrated residual symptoms in patients who have participated in posttraumatic stress disorder (PTSD) treatment, no studies to date have assessed residual PTSD symptoms following treatment for comorbid alcohol use disorder (AUD) and PTSD (PTSD/AUD). We examined residual symptoms of PTSD and AUD in 73 veterans with PTSD/AUD who completed a posttreatment assessment after being randomized to receive either Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE) or Seeking Safety (SS). We used logistic regression to identify differences (a) in residual PTSD and AUD symptoms among participants randomized to COPE versus SS and (b) among those with versus without a posttreatment PTSD/AUD diagnosis within both treatment conditions. Participants randomized to SS were more likely to report persistent avoidance, inability to experience positive emotions, hypervigilance, difficulty concentrating, and difficulty sleeping, ORs = 3.74-6.21. There were no differences between COPE and SS regarding the likelihood of persistent AUD symptoms. Participants without a posttreatment PTSD diagnosis had lower conditional probabilities of most symptoms, although exaggerated startle, OR = 0.71, and irritability/aggression, OR = 0.58, were most likely to persist. Participants without a posttreatment AUD diagnosis had lower conditional probabilities of most symptoms, although withdrawal, OR = 0.21; unsuccessful quit attempts, OR = 0.04; and higher intake, OR = 0.01, were most likely to persist. Findings indicate hyperarousal may warrant additional intervention following PTSD treatment. Residual AUD symptoms may relate to the enduring nature of some AUD symptoms rather than a lack of treatment efficacy.",2020,"Participants randomized to SS were more likely to report persistent avoidance, inability to experience positive emotions, hypervigilance, difficulty concentrating, and difficulty sleeping, ORs = 3.74-6.21.","['patients who have participated in posttraumatic stress disorder (PTSD', '73 veterans with PTSD/AUD who completed a posttreatment assessment after being randomized to receive either']","['Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE) or Seeking Safety (SS', 'Integrated Exposure Treatment Versus Coping Skills Treatment', 'SS']","['persistent avoidance, inability to experience positive emotions, hypervigilance, difficulty concentrating, and difficulty sleeping', 'conditional probabilities of most symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}]","[{'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0235013', 'cui_str': 'Hypervigilance'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",73.0,0.0172857,"Participants randomized to SS were more likely to report persistent avoidance, inability to experience positive emotions, hypervigilance, difficulty concentrating, and difficulty sleeping, ORs = 3.74-6.21.","[{'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Tripp', 'Affiliation': 'VA San Diego Healthcare System, San Diego, California, USA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Angkaw', 'Affiliation': 'VA San Diego Healthcare System, San Diego, California, USA.'}, {'ForeName': 'Paula P', 'Initials': 'PP', 'LastName': 'Schnurr', 'Affiliation': 'National Center for PTSD, White River Junction, Vermont, USA.'}, {'ForeName': 'Ryan S', 'Initials': 'RS', 'LastName': 'Trim', 'Affiliation': 'VA San Diego Healthcare System, San Diego, California, USA.'}, {'ForeName': 'Moira', 'Initials': 'M', 'LastName': 'Haller', 'Affiliation': 'VA San Diego Healthcare System, San Diego, California, USA.'}, {'ForeName': 'Brittany C', 'Initials': 'BC', 'LastName': 'Davis', 'Affiliation': ""James A. Haley Veteran's Hospital, Tampa, Florida, USA.""}, {'ForeName': 'Sonya B', 'Initials': 'SB', 'LastName': 'Norman', 'Affiliation': 'VA San Diego Healthcare System, San Diego, California, USA.'}]",Journal of traumatic stress,['10.1002/jts.22552']
2627,32557868,"A Randomized, Controlled Trial of Exercise for Parkinsonian Individuals With Freezing of Gait.","BACKGROUND


Exercises with motor complexity induce neuroplasticity in individuals with Parkinson's disease (PD), but its effects on freezing of gait are unknown. The objective of this study was to verify if adapted resistance training with instability - exercises with motor complexity will be more effective than traditional motor rehabilitation - exercises without motor complexity in improving freezing-of-gait severity, outcomes linked to freezing of gait, and brain function.
METHODS


Freezers were randomized either to the adapted resistance training with instability group (n = 17) or to the active control group (traditional motor rehabilitation, n = 15). Both training groups performed exercises 3 times a week for 12 weeks. The primary outcome was the New Freezing of Gait Questionnaire. Secondary outcomes were freezing of gait ratio (turning task), cognitive inhibition (Stroop-III test), motor signs (Unified Parkinson's Disease Rating Scale part-III [UPDRS-III]), quality of life (PD Questionnaire 39), anticipatory postural adjustment (leg-lifting task) and brain activation during a functional magnetic resonance imaging protocol of simulated anticipatory postural adjustment task. Outcomes were evaluated before and after interventions.
RESULTS


Only adapted resistance training with instability improved all the outcomes (P < 0.05). Adapted resistance training with instability was more effective than traditional motor rehabilitation (in improving freezing-of-gait ratio, motor signs, quality of life, anticipatory postural adjustment amplitude, and brain activation; P < 0.05). Our results are clinically relevant because improvement in the New Freezing of Gait Questionnaire (-4.4 points) and UPDRS-III (-7.4 points) scores exceeded the minimally detectable change (traditional motor rehabilitation group data) and the moderate clinically important difference suggested for PD, respectively. The changes in mesencephalic locomotor region activation and in anticipatory postural adjustment amplitude explained the changes in New Freezing of Gait Questionnaire scores and in freezing-of-gait ratio following adapted resistance training with instability, respectively.
CONCLUSIONS


Adapted resistance training with instability is able to cause significant clinical improvement and brain plasticity in freezers. © 2020 International Parkinson and Movement Disorder Society.",2020,"Adapted resistance training with instability was more effective than traditional motor rehabilitation (in improving freezing-of-gait ratio, motor signs, quality of life, anticipatory postural adjustment amplitude, and brain activation; P < 0.05).","['Parkinsonian Individuals With Freezing of Gait', ""individuals with Parkinson's disease (PD"", 'Freezers']",['adapted resistance training with instability group (n = 17) or to the active control group (traditional motor rehabilitation'],"['simulated anticipatory postural adjustment task', 'Gait Questionnaire scores', ""freezing of gait ratio (turning task), cognitive inhibition (Stroop-III test), motor signs (Unified Parkinson's Disease Rating Scale part-III [UPDRS-III]), quality of life (PD Questionnaire 39), anticipatory postural adjustment (leg-lifting task) and brain activation"", 'New Freezing of Gait Questionnaire', 'freezing-of-gait ratio, motor signs, quality of life, anticipatory postural adjustment amplitude, and brain activation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0175738', 'cui_str': 'Freezer'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0541749', 'cui_str': 'Does turn'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0205314', 'cui_str': 'New'}]",,0.0269952,"Adapted resistance training with instability was more effective than traditional motor rehabilitation (in improving freezing-of-gait ratio, motor signs, quality of life, anticipatory postural adjustment amplitude, and brain activation; P < 0.05).","[{'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Silva-Batista', 'Affiliation': 'Laboratory of Strength Training, School of Physical Education and Sport, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Andrea Cristina', 'Initials': 'AC', 'LastName': 'de Lima-Pardini', 'Affiliation': ""Centre for Neuroscience Studies, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Mariana Penteado', 'Initials': 'MP', 'LastName': 'Nucci', 'Affiliation': 'Department of Radiology, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Daniel Boari', 'Initials': 'DB', 'LastName': 'Coelho', 'Affiliation': 'Biomedical Engineering, Federal University of ABC, São Bernardo do Campo, SP, Brazil.'}, {'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'Batista', 'Affiliation': 'Department of Radiology, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Maria Elisa Pimentel', 'Initials': 'MEP', 'LastName': 'Piemonte', 'Affiliation': 'Faculty of Medical Science, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Egberto Reis', 'Initials': 'ER', 'LastName': 'Barbosa', 'Affiliation': 'Movement Disorders Clinic, Department of Neurology, School of Medicine of the University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Luis Augusto', 'Initials': 'LA', 'LastName': 'Teixeira', 'Affiliation': 'Human Motor Systems Laboratory, School of Physical Education and Sport, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Corcos', 'Affiliation': 'Department of Physical Therapy and Human Movement Sciences, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Edson', 'Initials': 'E', 'LastName': 'Amaro', 'Affiliation': 'Department of Radiology, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Fay B', 'Initials': 'FB', 'LastName': 'Horak', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, Oregon, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ugrinowitsch', 'Affiliation': 'Laboratory of Strength Training, School of Physical Education and Sport, University of São Paulo, São Paulo, SP, Brazil.'}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.28128']
2628,32557872,"L-Carnitine metabolism, protein turnover and energy expenditure in supplemented and exercised Labrador Retrievers.","L-Carnitine is critical for protection against bioaccumulation, long-chain fatty acid transportation and energy production. Energy production becomes important as the body maintains lean mass, repairs muscles and recovers from oxidative stress. The aim was to investigate the effects of supplemented L-carnitine on protein turnover (PT), energy expenditure (EE) and carnitine metabolism in muscle/serum of Labrador Retrievers. In a series of experiments, all dogs were fed a low-carnitine diet and sorted into one of two groups: L-carnitine (LC) supplemented daily with 125 mg L-carnitine and 3.75 g sucrose or placebo (P) supplemented with 4 g sucrose daily. The experiments consisted of analyses of muscle/serum for L-carnitine content (EXP1), a protein turnover experiment (EXP2) and analysis of substrate utilization via indirect calorimetry (EXP3). EXP1: 20 Labradors (10 M/10 F) performed a 13 week running regimen. L-Carnitine content was analysed in the serum and biceps femoris muscle before/after a 24.1 km run. LC serum had higher total (p < .001; p = .001), free (p < .001; p = .001) and esterified (p = .001; p = .003) L-carnitine pre- and post-run respectively. LC muscle had significantly higher free L-carnitine post-run (p = .034). EXP2: 26 Labs (13 M/13 F) performed a 60-day running regimen. For the final run, half of the Labradors from each treatment rested and half ran 24.1 km. Twenty-four Labradors received isotope infusion, and then, a biopsy of the biceps femoris of all 26 Labradors was taken to determine PT. Resting/exercised LC had a lower fractional breakdown rate (FBR) versus P group (p = .042). LC females had a lower FBR v. P females (p = .046). EXP3: Respiration of 16 Labradors (8 M/8 F) was measured via indirect calorimetry over 15 week. All dogs ran on a treadmill for 30 min at 30% VO 2  max (6.5 kph), resulting in higher maximum and mean EE in LC females v. P females (p = .021; p = .035). Implications for theory, practice and future research are discussed.",2020,Resting/exercised LC had a lower fractional breakdown rate (FBR) versus P group (p = .042).,"['muscle/serum of Labrador Retrievers', '16 Labradors (8 M/8 F']","['supplemented L-carnitine', 'EXP3', 'muscle/serum for L-carnitine content (EXP1), a protein turnover experiment (EXP2) and analysis of substrate utilization via indirect calorimetry (EXP3', 'L-carnitine (LC) supplemented daily with 125\xa0mg L-carnitine and 3.75\xa0g sucrose or placebo (P) supplemented with 4\xa0g sucrose daily']","['protein turnover (PT), energy expenditure (EE) and carnitine metabolism', 'L-Carnitine metabolism, protein turnover and energy expenditure', 'fractional breakdown rate (FBR', 'L-Carnitine content']","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0324431', 'cui_str': 'Labrador retriever'}, {'cui': 'C0022888', 'cui_str': 'Labrador'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0087163', 'cui_str': 'Levocarnitine'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0038164', 'cui_str': 'Protein A'}, {'cui': 'C0031227', 'cui_str': 'Employee Turnover'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0006781', 'cui_str': 'Indirect calorimetry'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C4517697', 'cui_str': '3.75'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0031227', 'cui_str': 'Employee Turnover'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0007258', 'cui_str': 'Carnitine'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0087163', 'cui_str': 'Levocarnitine'}, {'cui': 'C0699900', 'cui_str': 'Catabolism'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]",,0.0170811,Resting/exercised LC had a lower fractional breakdown rate (FBR) versus P group (p = .042).,"[{'ForeName': 'Jessica Lyn', 'Initials': 'JL', 'LastName': 'Varney', 'Affiliation': 'Four Rivers Kennel LLC, Walker, MO, USA.'}, {'ForeName': 'Jason William', 'Initials': 'JW', 'LastName': 'Fowler', 'Affiliation': 'Four Rivers Kennel LLC, Walker, MO, USA.'}, {'ForeName': 'Trenda Clarice', 'Initials': 'TC', 'LastName': 'McClaughry', 'Affiliation': 'ELIAS Animal Health LLC, Olathe, KS, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Vignale', 'Affiliation': 'Kemin Industries Inc., Des Moines, IA, USA.'}, {'ForeName': 'Justina', 'Initials': 'J', 'LastName': 'Caldas', 'Affiliation': 'Cobb-Vantress Inc., Siloam Springs, AR, USA.'}, {'ForeName': 'Jordan Taylor', 'Initials': 'JT', 'LastName': 'Weil', 'Affiliation': 'University of Arkansas, Fayetteville, AR, USA.'}, {'ForeName': 'Craig Nelson', 'Initials': 'CN', 'LastName': 'Coon', 'Affiliation': 'Four Rivers Kennel LLC, Walker, MO, USA.'}]",Journal of animal physiology and animal nutrition,['10.1111/jpn.13391']
2629,32557974,Association between biomarkers and house dust mite sublingual immunotherapy in allergic asthma.,"BACKGROUND


House dust mite (HDM) sublingual immunotherapy (SLIT) has demonstrated efficacy in clinical trials of patients with asthma. Airway inflammation is a characteristics of respiratory allergy, but its relationship to SLIT remain unclear.
OBJECTIVE


We evaluate the association between clinical outcomes with pulmonary function and biomarkers in before and after HDM SLIT (UMIN-Number 000022390).
METHODS


One hundred twelve patients with asthma sensitized to HDM were randomized to add-on 6 standardized quality (SQ)-HDM SLIT to pharmacotherapy or pharmacotherapy alone for 48 weeks. At baseline and end of study, biomarkers, blood eosinophils, serum IgE, serum periostin, fractional exhaled nitric oxide (FeNO), and spirometry and clinical symptoms were measured. Association between biomarkers and an increase in FEV 1  of 120 ml or greater were analyzed.
RESULTS


SLIT demonstrated a significant reduction of serum periostin (P < 0.001), FeNO (P < 0.01), and increase in HDM specific IgE (P < 0.05), FEV 1  (P < 0.001) and improvement of clinical symptom scores, when compared to pharmacotherapy. The change in FEV 1  correlated with the changes in serum periostin (r = 0.696, P < 0.001) and the changes in FeNO (r = 0.682, P < 0.001). The independent predictor of improvement in airflow limitation were change in serum periostin (r 2  = 0.753, P = 0.013) and FeNO (P = 0.038). Based on cutoff values derived by receiver operating characteristic analysis (periostin 30.9 ng/mL, FeNO 28.0 ppb), patients were distinguished responders from non-responders, but with no predictive value for blood eosinophils or total IgE. The proportion of patients with both high periostin and FeNO levels was significantly higher in responder than in non-responder (P = 0.026).
CONCLUSIONS AND CLINICAL RELEVANCE


Adding HDM SLIT to pharmacotherapy resulted in reduced serum periostin and FeNO, and improved pulmonary function. Serum periostin and FeNO may be useful biomarkers for prediction of SLIT.",2020,"The independent predictor of improvement in airflow limitation were change in serum periostin (r 2  = 0.753, P = 0.013) and FeNO (P = 0.038).","['patients with asthma', 'One hundred twelve patients with asthma sensitized to HDM', 'allergic asthma']","['standardized quality (SQ)-HDM SLIT to pharmacotherapy or pharmacotherapy alone', 'House dust mite (HDM) sublingual immunotherapy (SLIT']","['airflow limitation', 'HDM specific IgE', 'clinical symptom scores', 'serum periostin and FeNO, and improved pulmonary function', 'FeNO levels', 'changes in FeNO', 'serum periostin', 'FeNO', 'blood eosinophils or total IgE', 'biomarkers, blood eosinophils, serum IgE, serum periostin, fractional exhaled nitric oxide (FeNO), and spirometry and clinical symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0998367', 'cui_str': 'House dust mite'}, {'cui': 'C0155877', 'cui_str': 'Allergic asthma'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0998367', 'cui_str': 'House dust mite'}, {'cui': 'C3658366', 'cui_str': 'Sublingual Immunotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C1270515', 'cui_str': 'House dust mite (Bt) specific immunoglobulin E'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0219433', 'cui_str': 'POSTN protein, human'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}]",112.0,0.0433362,"The independent predictor of improvement in airflow limitation were change in serum periostin (r 2  = 0.753, P = 0.013) and FeNO (P = 0.038).","[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Hoshino', 'Affiliation': 'Division of Clinical Allergy, Department of Internal Medicine, Atami Hospital, International University of Health and Welfare, Atami, Japan.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Akitsu', 'Affiliation': 'Department of Radiology, Atami Hospital, International University of Health and Welfare, Atami, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Kubota', 'Affiliation': 'Department of Radiology, Atami Hospital, International University of Health and Welfare, Atami, Japan.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Ohtawa', 'Affiliation': 'Department of Radiology, Atami Hospital, International University of Health and Welfare, Atami, Japan.'}]",Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology,['10.1111/cea.13686']
2630,32544269,Evaluation of preventive laser photobiomodulation in patients with head and neck cancer undergoing radiochemotherapy: Laser in patients with head and neck cancer.,"AIMS


This study aimed to evaluate the effect of laser photobiomodulation in the prevention of oral mucositis (OM), salivary hypofunction and referred pain in patients with head and neck cancer.
METHODS AND RESULTS


This randomized clinical study divided patients into two groups: the laser group (LG, n = 30) and the control group (CG, n = 24). The LG (InGaAlP, 660 nm, 86.7 mW, 2 J/cm 2  ) participated in the preventive protocol, while the CG underwent a simulated procedure without light emission. The degree of OM, salivary flow, and referred pain were evaluated at five different periods of radiotherapy. Both groups showed a significant increase in the degree of OM (P < .01). Regarding OM, salivary flow, and oral pain, there were no significant differences between the groups.
CONCLUSIONS


The laser photobiomodulation protocol used in this study was not effective in preventing radiochemotherapy-induced OM, salivary hypofunction, and referred pain in patients with head and neck cancer. Notably, although the development of OM did not differ significantly according to the use of laser therapy, the severity of oral mucositis was reduced in patients who underwent laser therapy compared to that in patients who did not.",2020,Both groups showed a significant increase in the degree of OM (P < .01).,"['patients with head and neck cancer', 'patients with head and neck cancer undergoing']","['laser therapy', 'radiochemotherapy', 'preventive laser photobiomodulation', 'laser photobiomodulation']","['oral mucositis (OM), salivary hypofunction and referred pain', 'severity of oral mucositis', 'degree of OM', 'OM, salivary flow, and oral pain', 'degree of OM, salivary flow, and referred pain', 'OM']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}]","[{'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}]","[{'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0234250', 'cui_str': 'Referred pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0221776', 'cui_str': 'Painful mouth'}]",,0.020856,Both groups showed a significant increase in the degree of OM (P < .01).,"[{'ForeName': 'Juliana Borges de Lima', 'Initials': 'JBL', 'LastName': 'Dantas', 'Affiliation': 'Masters in Dentistry at Bahiana School of Medicine and Public Health, Salvador, Bahia, Brazil.'}, {'ForeName': 'Gabriela Botelho', 'Initials': 'GB', 'LastName': 'Martins', 'Affiliation': 'Associate Professor of Health Sciences Institute of the Federal University of Bahia, Salvador, Bahia, Brazil.'}, {'ForeName': 'Hayana Ramos', 'Initials': 'HR', 'LastName': 'Lima', 'Affiliation': 'Adjunct Professor, Center of Health Sciences, Federal University of Southern Bahia, Teixeira de Freitas, Bahia, Brazil.'}, {'ForeName': 'Manoela', 'Initials': 'M', 'LastName': 'Carrera', 'Affiliation': 'Adjunct Professor of Stomatology at the Federal University of Bahia, Salvador, Bahia, Brazil.'}, {'ForeName': 'Sílvia Regina de Almeida', 'Initials': 'SRA', 'LastName': 'Reis', 'Affiliation': 'Adjunct Professor at Bahiana - School of Medicine and Public Health, Salvador, Bahia, Brazil.'}, {'ForeName': 'Alena Ribeiro Alves Peixoto', 'Initials': 'ARAP', 'LastName': 'Medrado', 'Affiliation': 'Adjunct Professor at Bahiana - School of Medicine and Public Health, Salvador, Bahia, Brazil.'}]","Special care in dentistry : official publication of the American Association of Hospital Dentists, the Academy of Dentistry for the Handicapped, and the American Society for Geriatric Dentistry",['10.1111/scd.12486']
2631,32544283,Restored pelvic anatomy is preserved after laparoscopic and robot-assisted ventral rectopexy: MRI-based 5-year follow-up of a randomised controlled trial.,"AIM


We compared the long-term anatomical outcomes between robot-assisted (RVMR) and laparoscopic ventral mesh rectopexy (LVMR) for external or internal rectal prolapse.
METHOD


This study is a follow-up of a single centre randomised controlled trial (RCT). Thirty patients were randomly allocated to RVMR (n=16) and LVMR (n = 14). The primary endpoint was the maintenance of the restored pelvic anatomy 5 years after the operation as assessed by magnetic resonance (MR) defaecography. Secondary outcome measures included the Pelvic Organ Prolapse Quantification (POP-Q) measures and functional results assessed using symptom questionnaires.
RESULTS


Twenty-six patients (14 RVMR and 12 LVMR) completed the 5-year follow-up and were included in the study. The MR imaging (MRI) results, POP-Q measurements and symptom-specific quality of life measures did not differ between the RVMR and LVMR groups. The MRI measurements of the total study population remained unchanged between 3 months and 5 years. In the pelvic floor distress inventory (PFDI-20), the RVMR group had lower symptom scores (mean 96.0, SD 70.7) than the LVMR group (mean 160.6, SD 58.9; p=0.004). In the subscales of pelvic organ prolapse (POPDI-6) (mean 23.2, SD 24.3 vs mean 52.4, SD 22.4; p=0.001) and the colorectal-anal distress inventory (CRADI-8) (mean 38.4, SD 23.3 vs mean 58.6, SD 25.4; p=0.009), the patients in the RVMR group had significantly better outcomes.
CONCLUSION


After VMR, the corrected anatomy was preserved. There were no clinically significant differences in anatomical results between the RVMR and LVMR procedures 5 years after surgery based on MR defaecography. However functional outcomes were better after RMVR.",2020,"The MR imaging (MRI) results, POP-Q measurements and symptom-specific quality of life measures did not differ between the RVMR and LVMR groups.","['Twenty-six patients (14 RVMR and 12 LVMR) completed the 5-year follow-up and were included in the study', 'Thirty patients']","['RVMR', 'robot-assisted (RVMR) and laparoscopic ventral mesh rectopexy (LVMR', 'LVMR']","['maintenance of the restored pelvic anatomy 5 years after the operation as assessed by magnetic resonance (MR) defaecography', 'colorectal-anal distress inventory (CRADI-8', 'pelvic organ prolapse (POPDI-6', 'Pelvic Organ Prolapse Quantification (POP-Q) measures and functional results assessed using symptom questionnaires', 'MR imaging (MRI) results, POP-Q measurements and symptom-specific quality of life measures', 'symptom scores']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0400222', 'cui_str': 'Mesh rectopexy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0400222', 'cui_str': 'Mesh rectopexy'}]","[{'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0524966', 'cui_str': 'Defecography'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0003461', 'cui_str': 'Anal structure'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",30.0,0.123838,"The MR imaging (MRI) results, POP-Q measurements and symptom-specific quality of life measures did not differ between the RVMR and LVMR groups.","[{'ForeName': 'K E', 'Initials': 'KE', 'LastName': 'Laitakari', 'Affiliation': 'Department of Surgery, Division of Gastroenterology, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Mäkelä-Kaikkonen', 'Affiliation': 'Department of Surgery, Division of Gastroenterology, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Pääkkö', 'Affiliation': 'Department of Radiology, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Kata', 'Affiliation': 'Department of Radiology, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ohtonen', 'Affiliation': 'Medical Research Center Oulu, Center of Surgical Research, University of Oulu, Oulu, Finland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mäkelä', 'Affiliation': 'Department of Surgery, Division of Gastroenterology, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'T T', 'Initials': 'TT', 'LastName': 'Rautio', 'Affiliation': 'Department of Surgery, Division of Gastroenterology, Oulu University Hospital, Oulu, Finland.'}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.15195']
2632,32544297,Long-term safety and efficacy of N8-GP in previously treated adults and adolescents with hemophilia A: Final results from pathfinder2.,"BACKGROUND


N8-GP (turoctocog alfa pegol; Esperoct ®  , Novo Nordisk A/S, Bagsvaerd, Denmark) is a glycoPEGylated human recombinant factor VIII with a half-life of ~1.6-fold of standard FVIII products. pathfinder2 (NCT01480180) was a multi-national, open-label trial of N8-GP in previously treated adolescent and adult patients with severe hemophilia A.
OBJECTIVE


We report end-of-trial efficacy and safety of N8-GP from pathfinder2.
METHODS


pathfinder2 main phase and extension phase part 1 results have been previously reported. During extension phase part 2, patients could switch from N8-GP prophylaxis 50 IU/kg every fourth day (Q4D) or 75 IU/kg once-weekly (Q7D), depending on bleeding status. Extension phase part 2 collected long-term safety and efficacy data for all regimens until trial end (first patient in main phase, 30 Jan 2012; trial end, 10 Dec 2018).
RESULTS


Overall, 186 patients were exposed to N8-GP for up to 6.6 years (median 5.4 years). The estimated annualized bleeding rate (ABR) was 2.14 (median 0.84) for the Q4D prophylaxis arm and 1.31 (median 1.67) for the Q7D prophylaxis arm. Nearly 30% of patients experienced 0 bleeds throughout the entire duration of the trial, the hemostatic response was 83.2% across all treatment arms, and patient-reported outcomes were maintained or slightly improved. No safety concerns were detected.
CONCLUSION


Data from the completed pathfinder2 trial, one of the largest and longest-running clinical trials to investigate treatment of severe hemophilia A, demonstrate the efficacy and safety of N8-GP in previously treated adolescent and adult patients.",2020,The estimated annualized bleeding rate (ABR) was 2.14 (median 0.84) for the Q4D prophylaxis arm and 1.31 (median 1.67) for the Q7D prophylaxis arm.,"['previously treated adults and adolescents with hemophilia A', 'previously treated adolescent and adult patients', '186 patients were exposed to N8-GP for up to 6.6\xa0years (median 5.4\xa0years', 'previously treated adolescent and adult patients with severe hemophilia A']",['N8-GP'],"['hemostatic response', 'annualized bleeding rate (ABR']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C4517823', 'cui_str': '6.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0272322', 'cui_str': 'Severe hereditary factor VIII deficiency disease'}]",[],"[{'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",186.0,0.0938106,The estimated annualized bleeding rate (ABR) was 2.14 (median 0.84) for the Q4D prophylaxis arm and 1.31 (median 1.67) for the Q7D prophylaxis arm.,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Giangrande', 'Affiliation': 'Department of Clinical and Laboratory Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Faraizah', 'Initials': 'F', 'LastName': 'Abdul Karim', 'Affiliation': 'National Blood Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Laszlo', 'Initials': 'L', 'LastName': 'Nemes', 'Affiliation': 'National Hemophilia Center, Hemostasis Department, Medical Center, Hungarian Defence Forces, Budapest, Hungary.'}, {'ForeName': 'Chur Woo', 'Initials': 'CW', 'LastName': 'You', 'Affiliation': 'Pediatric Department, Eulji University Hospital, Daejeon, Republic of Korea.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Landorph', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Milan S', 'Initials': 'MS', 'LastName': 'Geybels', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Curry', 'Affiliation': 'Oxford Haemophilia and Thrombosis Centre and Oxford National Institute for Health Research Biomedical Research Centre, Churchill Hospital, Oxford, UK.'}]",Journal of thrombosis and haemostasis : JTH,['10.1111/jth.14959']
2633,32544346,Promoting unsupervised walking in women with fibromyalgia: a randomized controlled trial.,"The objective of this study is to test the efficacy of a group motivational plus implementation intentions intervention in promoting adherence to an unsupervised walking program recommended for fibromyalgia, compared to an implementation intentions condition and to an active control condition. A triple-blind, randomized, longitudinal study with measures at baseline, short (seven weeks post-intervention), mid (12 weeks) and long-term (36 weeks) is performed. Data are analyzed using multilevel longitudinal growth curve two-level modelling. Participants are 157 women with fibromyalgia. In the short-term, adherence to the minimum and to the standard walking program (primary outcome measures) is explained by time (both  p  <.001), motivational plus implementation intentions intervention (both  p  <.001) and by their interaction (both  p  <.001). Regarding the secondary outcomes, only physical function is explained by time ( p  <.001), motivational plus implementation intentions intervention ( p  <.05) and by their interaction ( p  <.05). Motivational plus implementation intentions intervention achieve the promotion of walking as an exercise in the short-term; furthermore, physical function of the women in this condition is better than in the other two intervention groups, which is a relevant outcome from a rehabilitation point of view. However, more studies are needed to maintain the exercise at mid and long-term.",2020,"Regarding the secondary outcomes, only physical function is explained by time ( p  <.001), motivational plus implementation intentions intervention ( p  <.05) and by their interaction ( p  <.05).","['women with fibromyalgia', '157 women with fibromyalgia']","['group motivational plus implementation intentions intervention', 'Motivational plus implementation intentions intervention']",['motivational plus implementation intentions intervention'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",157.0,0.0679611,"Regarding the secondary outcomes, only physical function is explained by time ( p  <.001), motivational plus implementation intentions intervention ( p  <.05) and by their interaction ( p  <.05).","[{'ForeName': 'María A', 'Initials': 'MA', 'LastName': 'Pastor-Mira', 'Affiliation': 'Department of Behavioral Sciences & Health, Miguel Hernández University , Spain.'}, {'ForeName': 'Sofía', 'Initials': 'S', 'LastName': 'López-Roig', 'Affiliation': 'Department of Behavioral Sciences & Health, Miguel Hernández University , Spain.'}, {'ForeName': 'Fermín', 'Initials': 'F', 'LastName': 'Martínez-Zaragoza', 'Affiliation': 'Department of Behavioral Sciences & Health, Miguel Hernández University , Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Lledó', 'Affiliation': 'Department of Behavioral Sciences & Health, Miguel Hernández University , Spain.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Velasco', 'Affiliation': 'Department of Medicine & Surgery, Psychology, Preventive Medicine & Public Health, Rey Juan Carlos University , Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'León', 'Affiliation': 'Department of Behavioral Sciences & Health, Miguel Hernández University , Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Écija Gallardo', 'Affiliation': 'Department of Medicine & Surgery, Psychology, Preventive Medicine & Public Health, Rey Juan Carlos University , Spain.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Peñacoba', 'Affiliation': 'Department of Medicine & Surgery, Psychology, Preventive Medicine & Public Health, Rey Juan Carlos University , Spain.'}]","Psychology, health & medicine",['10.1080/13548506.2020.1774068']
2634,32544356,Effect of photobiomodulation on pain level during local anesthesia injection: a randomized clinical trial.,"The aim of this study was to investigate the effect of photobiomodulation therapy (PBMT) as pre-treatment on pain level during injection in the anterior maxillary region. 56 Patients were randomly divided into 3 groups, Group 1:980 nm diode laser (n = 22) (experimental), Group 2:980 nm diode laser probe placed in vestibule without radiation (placebo) (n = 22), Group3: no pre-treatment before injection (n = 12) (control). Pain level during injection was evaluated by visual analog scale (VAS). The severity of pain in Group 1(experimental) and Group 2 (placebo) was significantly lower than Group 3 (control). Group 1 had a lesser pain level than Group 2, but the difference in pain level between them was not significant. PBMT with 980 nm wavelength decreased pain level during local anesthesia injection without superiority over placebo.",2020,The severity of pain in Group 1(experimental) and Group 2 (placebo) was significantly lower than Group 3 (control).,"['PBMT with 980', '56 Patients']","['nm diode laser', 'Group 2 (placebo', 'photobiomodulation', 'photobiomodulation therapy (PBMT', 'diode laser probe placed in vestibule without radiation (placebo) (n\xa0=\xa022), Group3', 'local anesthesia injection', 'placebo']","['severity of pain', 'pain level', 'visual analog scale (VAS', 'Pain level']","[{'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C1735318', 'cui_str': 'Vestibular apparatus'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",56.0,0.0621936,The severity of pain in Group 1(experimental) and Group 2 (placebo) was significantly lower than Group 3 (control).,"[{'ForeName': 'Sholeh', 'Initials': 'S', 'LastName': 'Ghabraei', 'Affiliation': 'Associate Professor, Endodontic Department, School of Dentistry, Tehran University of Medical Sciences , Tehran, Iran.'}, {'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Bolhari', 'Affiliation': 'Associate Professor, Laser Research Center of Dentistry, Dentistry Research Institute, Endodontic Department, School of Dentistry, Tehran University of Medical Sciences , Tehran, Iran.'}, {'ForeName': 'Hasan Mohammad', 'Initials': 'HM', 'LastName': 'Nashtaie', 'Affiliation': 'General Practitioner , Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Noruzian', 'Affiliation': 'Assistant Professor, Orthodontics Department, Dental School, Ilam University of Medical Sciences , Ilam, Iran.'}, {'ForeName': 'Soheil', 'Initials': 'S', 'LastName': 'Niavarzi', 'Affiliation': 'Associate Professor, Endodontic Department, School of Dentistry, Tehran University of Medical Sciences , Tehran, Iran.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Chiniforush', 'Affiliation': 'Assistant Professor, Dental Implant Research Center, Dentistry Research Institute, Tehran University of Medial Sciences , Tehran, Iran.'}]",Journal of cosmetic and laser therapy : official publication of the European Society for Laser Dermatology,['10.1080/14764172.2020.1778173']
2635,32544361,Immunogenicity of an  Escherichia coli -produced bivalent human papillomavirus vaccine under different vaccination intervals.,"A new  Escherichia coli -produced human papillomavirus (HPV)-16/18 vaccine has been shown to be safe and highly efficacious and was recently licensed in China. As a post hoc analysis of the phase III trial, this study aimed to assess the impact of vaccination time deviations on the specific antibody response and guide the better usage of this vaccine in the real world. A total of 3689 healthy women aged 18-45 years old were randomly assigned to receive the bivalent HPV-16/18 vaccine according to a 0-, 1- and 6-month schedule with a wide vaccination interval. The first vaccination interval between the 1 st  and 2 nd  doses (the 1 st  interval) was divided into three groups: 28-40 d, 41-50 d and 51-60 d. The second vaccination interval between the 2 nd  and 3 rd  doses (the 2 nd  interval) was divided into three groups: 103-139 d, 140-160 d and 161-198 d. The reverse cumulative curves for the IgG of the three groups with different 1 st  vaccination intervals or with different 2 nd  vaccination intervals at month 7 almost overlapped for both HPV-16 and HPV-18. Compared with the standard vaccination schedule (a 1 st  interval of 28-40 d and a 2 nd  interval of 140-160 d) subgroup, all the subgroups had GMC ratios greater than 0.83, with the lower limit of 95% CIs higher than 0.64. In conclusion, a slight deviation in the vaccination time of the 2 nd  and 3 rd  doses has only a minor, insignificant impact on the immune response induced by the  Escherichia coli -produced HPV-16/18 vaccine.",2020,The reverse cumulative curves for the IgG of the three groups with different 1 st  vaccination intervals or with different 2 nd  vaccination intervals at month 7 almost overlapped for both HPV-16 and HPV-18.,"['Escherichia coli -produced bivalent human papillomavirus vaccine under different vaccination intervals', '3689 healthy women aged 18-45\xa0years old']",['bivalent HPV-16/18 vaccine'],"['Immunogenicity', 'GMC ratios']","[{'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C1721788', 'cui_str': 'human papillomavirus vaccine, L1 type 16, 18'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}]",3689.0,0.0525128,The reverse cumulative curves for the IgG of the three groups with different 1 st  vaccination intervals or with different 2 nd  vaccination intervals at month 7 almost overlapped for both HPV-16 and HPV-18.,"[{'ForeName': 'Xiao-Juan', 'Initials': 'XJ', 'LastName': 'Yu', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Strait Collaborative Innovation Center of Biomedicine and Pharmaceutics(SCIBP), School of Public Health, Xiamen University , Xiamen, Fujian, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Division of Respiratory Virus Vaccines, National Institute for Food and Drug Control , Beijing, China.'}, {'ForeName': 'Zhi-Jie', 'Initials': 'ZJ', 'LastName': 'Lin', 'Affiliation': 'Vaccine R&D Department, Xiamen Innovax Biotech Company , Xiamen, Fujian, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Division of Respiratory Virus Vaccines, National Institute for Food and Drug Control , Beijing, China.'}, {'ForeName': 'Bi-Zhen', 'Initials': 'BZ', 'LastName': 'Lin', 'Affiliation': 'Vaccine R&D Department, Xiamen Innovax Biotech Company , Xiamen, Fujian, China.'}, {'ForeName': 'You-Lin', 'Initials': 'YL', 'LastName': 'Qiao', 'Affiliation': 'Department of Cancer Epidemiology, National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College , Beijing, China.'}, {'ForeName': 'Yue-Mei', 'Initials': 'YM', 'LastName': 'Hu', 'Affiliation': 'Department of Vaccine Evaluation, Jiangsu Provincial Center for Disease Control and Prevention , Nanjing, Jiangsu, China.'}, {'ForeName': 'Li-Hui', 'Initials': 'LH', 'LastName': 'Wei', 'Affiliation': ""Department of Obstetrics and Gynecology, Peking University People's Hospital , Beijing, China.""}, {'ForeName': 'Rong-Cheng', 'Initials': 'RC', 'LastName': 'Li', 'Affiliation': 'Center for Vaccine Clinical Research, Guangxi Center for Disease Control and Prevention , Nanning, Guangxi, China.'}, {'ForeName': 'Wei-Dan', 'Initials': 'WD', 'LastName': 'Huang', 'Affiliation': 'Vaccine R&D Department, Xiamen Innovax Biotech Company , Xiamen, Fujian, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Strait Collaborative Innovation Center of Biomedicine and Pharmaceutics(SCIBP), School of Public Health, Xiamen University , Xiamen, Fujian, China.'}, {'ForeName': 'Shou-Jie', 'Initials': 'SJ', 'LastName': 'Huang', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Strait Collaborative Innovation Center of Biomedicine and Pharmaceutics(SCIBP), School of Public Health, Xiamen University , Xiamen, Fujian, China.'}, {'ForeName': 'Chang-Gui', 'Initials': 'CG', 'LastName': 'Li', 'Affiliation': 'Division of Respiratory Virus Vaccines, National Institute for Food and Drug Control , Beijing, China.'}, {'ForeName': 'Hui-Rong', 'Initials': 'HR', 'LastName': 'Pan', 'Affiliation': 'Vaccine R&D Department, Xiamen Innovax Biotech Company , Xiamen, Fujian, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Strait Collaborative Innovation Center of Biomedicine and Pharmaceutics(SCIBP), School of Public Health, Xiamen University , Xiamen, Fujian, China.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2020.1761202']
2636,32544560,"Phase 3, Randomized, 20-Month Study of Bimatoprost Implant in Open-Angle Glaucoma and Ocular Hypertension (ARTEMIS 1).","OBJECTIVE


To evaluate the intraocular pressure (IOP)-lowering efficacy and safety of 10- and 15-μg bimatoprost implant in subjects with open-angle glaucoma (OAG) and ocular hypertension (OHT) after initial and repeated administrations.
DESIGN


Randomized, 20-month, multicenter, subject- and efficacy evaluator-masked, parallel-group, phase 3 clinical study.
PARTICIPANTS


Adults with OAG or OHT in each eye, open iridocorneal angle inferiorly in the study eye by clinical gonioscopy, and study eye baseline IOP (H0; 8 am±1 h) of 22-32 mmHg after washout.
METHODS


Study eyes received bimatoprost implant 10 μg (n=198) or 15 μg (n=198) on Day 1 with readministration at Weeks 16 and 32, or twice-daily topical timolol maleate 0.5% (n=198). IOP was measured at Hours 0 and 2 at each visit.
MAIN OUTCOME MEASURES


Primary endpoints were IOP and change from baseline IOP through Week 12. Safety measures included treatment-emergent adverse events (TEAEs) and corneal endothelial cell density (CECD).
RESULTS


Both dose strengths of bimatoprost implant were noninferior to timolol in IOP lowering after each administration. Mean diurnal IOP was 24.0, 24.2, and 23.9 mmHg at baseline and from 16.5-17.2, 16.5-17.0, and 17.1-17.5 mmHg through Week 12 in the 10-μg implant, 15-μg implant, and timolol groups, respectively. The incidence of corneal and inflammatory TEAEs of interest (eg, corneal endothelial cell loss, iritis) in study eyes was higher with bimatoprost implant than timolol and highest with the 15-μg dose strength. Incidence of corneal TEAEs of interest increased after repeated treatment; with 3 administrations at fixed 16-week intervals, incidence of ≥20% CECD loss was 10.2% (10-μg implant) and 21.8% (15-μg implant). Mean BCVA was stable; 3 implant-treated subjects with corneal TEAEs had >2-line BCVA loss at their last visit.
CONCLUSIONS


Both dose strengths of bimatoprost implant met the primary endpoint of noninferiority to timolol through Week 12. One year after 3 administrations, IOP was controlled in most subjects without additional treatment. The risk-benefit assessment favored the 10-μg implant over the 15-μg implant. Ongoing studies are evaluating other administration regimens to reduce the potential for CECD loss. The bimatoprost implant has potential to improve adherence and reduce treatment burden in glaucoma.",2020,Both dose strengths of bimatoprost implant were noninferior to timolol in IOP lowering after each administration.,"['Adults with OAG or OHT in each eye, open iridocorneal angle inferiorly in the study eye by clinical gonioscopy, and study eye baseline IOP (H0; 8 am±1 h) of 22-32 mmHg after washout', 'subjects with open-angle glaucoma (OAG) and ocular hypertension (OHT) after initial and repeated administrations']","['10- and 15-μg bimatoprost implant', 'timolol', 'bimatoprost implant 10 μg (n=198) or 15 μg (n=198) on Day 1 with readministration at Weeks 16 and 32, or twice-daily topical timolol maleate', 'Bimatoprost Implant']","['Mean diurnal IOP', 'IOP and change from baseline IOP', 'treatment-emergent adverse events (TEAEs) and corneal endothelial cell density (CECD', 'incidence of corneal and inflammatory TEAEs of interest (eg, corneal endothelial cell loss, iritis', 'Incidence of corneal TEAEs of interest', 'IOP', 'intraocular pressure (IOP)-lowering efficacy and safety', '2-line BCVA loss', 'incidence of ≥20% CECD loss', 'Mean BCVA']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0229238', 'cui_str': 'Structure of iridocorneal angle'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0018071', 'cui_str': 'Gonioscopy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C0028840', 'cui_str': 'Ocular hypertension'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0937917', 'cui_str': 'bimatoprost'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0040233', 'cui_str': 'Timolol'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0087093', 'cui_str': 'Timolol maleate'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C2717756', 'cui_str': 'Corneal endothelial cell loss'}, {'cui': 'C0022081', 'cui_str': 'Iritis'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]",,0.0864011,Both dose strengths of bimatoprost implant were noninferior to timolol in IOP lowering after each administration.,"[{'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Medeiros', 'Affiliation': 'Department of Ophthalmology, Duke University, Durham, North Carolina.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Walters', 'Affiliation': 'Keystone Research, Ltd, Austin, Texas.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Kolko', 'Affiliation': 'Department of Ophthalmology, Copenhagen University Hospital, Rigshospitalet-Glostrup, Glostrup, Denmark; Department of Drug Design and Pharmacology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Coote', 'Affiliation': 'Center for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Bejanian', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'Margot L', 'Initials': 'ML', 'LastName': 'Goodkin', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Guo', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Allergan plc, Madison, New Jersey.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Robinson', 'Affiliation': 'Allergan plc, Irvine, California. Electronic address: Robinson_Michael@Allergan.com.'}, {'ForeName': 'Robert N', 'Initials': 'RN', 'LastName': 'Weinreb', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, California.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2020.06.018']
2637,32544572,"A 10-week yoga practice has no effect on cognition, but improves balance and motor learning by attenuating brain-derived neurotrophic factor levels in older adults.","Despite studies investigating the effect of yoga on cognitive and motor functioning in older adults, the effect on dual-task performance and motor learning and the specific mechanisms underlying the positive effect of yoga remain unclear. Thus, the aim of this study was to investigate the effects of yoga on cognition, balance under single- and dual-task conditions, and motor learning. The potential role of brain-derived neurotrophic factor (BDNF) in induced improvement was also explored. Participants aged 60-79 years were randomized to either a control group (n = 15) or a yoga group (n = 18) for a 10-week period. The yoga group received 90-min duration yoga classes two times per week. Changes in cognition, balance under single- and dual-task conditions, and learning fast and accurate reaching movements were assessed. Yoga practice decreased (P < 0.05) the velocity vector of the center of pressure under single- and dual-task conditions, whereas no changes in cognitive performance were observed. Although reaction and movement times during learning were decreased in both groups (P < 0.05), a faster reaction time (P < 0.05) and shorter movement time (P < 0.05) were observed in the yoga group than in the control group. Significant moderate relationships (P < 0.05) between changes in BDNF levels and functional improvements were observed. Thus, 10 weeks of yoga practice resulted in improved balance and learning in the speed-accuracy motor task that were mediated by increased BDNF levels, but had no impact on cognition in older adults.",2020,"Although reaction and movement times during learning were decreased in both groups (P < 0.05), a faster reaction time (P < 0.05) and shorter movement time (P < 0.05) were observed in the yoga group than in the control group.","['Participants aged 60-79\u202fyears', 'older adults']","['brain-derived neurotrophic factor (BDNF', 'control group (n\u202f=\u202f15) or a yoga group']","['cognitive performance', 'Yoga practice', 'BDNF levels', 'shorter movement time', 'reaction and movement times during learning', 'velocity vector of the center of pressure under single- and dual-task conditions', 'Changes in cognition, balance under single- and dual-task conditions, and learning fast and accurate reaching movements', 'balance and learning', 'cognition, balance under single- and dual-task conditions, and motor learning', 'BDNF levels and functional improvements', 'faster reaction time']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",,0.0174528,"Although reaction and movement times during learning were decreased in both groups (P < 0.05), a faster reaction time (P < 0.05) and shorter movement time (P < 0.05) were observed in the yoga group than in the control group.","[{'ForeName': 'Agnė', 'Initials': 'A', 'LastName': 'Čekanauskaitė', 'Affiliation': 'Department of Health Promotion and Rehabilitation, Lithuanian Sports University, Kaunas, Lithuania. Electronic address: agne.cekanauskaite@lsu.lt.'}, {'ForeName': 'Albertas', 'Initials': 'A', 'LastName': 'Skurvydas', 'Affiliation': 'Department of Health Promotion and Rehabilitation, Lithuanian Sports University, Kaunas, Lithuania; Institute of Sports Science and Innovations, Lithuanian Sports University, Kaunas, Lithuania.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Žlibinaitė', 'Affiliation': 'Department of Health Promotion and Rehabilitation, Lithuanian Sports University, Kaunas, Lithuania.'}, {'ForeName': 'Dalia', 'Initials': 'D', 'LastName': 'Mickevičienė', 'Affiliation': 'Department of Health Promotion and Rehabilitation, Lithuanian Sports University, Kaunas, Lithuania; Institute of Sports Science and Innovations, Lithuanian Sports University, Kaunas, Lithuania.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Kilikevičienė', 'Affiliation': 'Department of Health Promotion and Rehabilitation, Lithuanian Sports University, Kaunas, Lithuania; Institute of Sports Science and Innovations, Lithuanian Sports University, Kaunas, Lithuania.'}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Solianik', 'Affiliation': 'Department of Health Promotion and Rehabilitation, Lithuanian Sports University, Kaunas, Lithuania; Institute of Sports Science and Innovations, Lithuanian Sports University, Kaunas, Lithuania.'}]",Experimental gerontology,['10.1016/j.exger.2020.110998']
2638,32544602,Clinician-patient movement synchrony mediates social group effects on interpersonal trust and perceived pain.,"Pain is an unfortunate consequence of many medical procedures, which in some patients becomes chronic and debilitating. Among the factors affecting medical pain, clinician-patient (C-P) similarity and nonverbal communication are particularly important for pain diagnosis and treatment. Participants (N=66) were randomly assigned to the clinician and patient roles and were grouped into C-P dyads. Clinicians administered painful stimuli to patients as an analogue of a painful medical procedure. We manipulated the perceived C-P similarity of each dyad using groups ostensibly based on shared beliefs and values, and each patient was tested twice: Once with a same group clinician (concordant, CC) and once with a clinician from the other group (discordant, DC). Movement synchrony was calculated as a marker of nonverbal communication. We tested whether movement synchrony mediated the effects of group concordance on patients' pain and trust in the clinician. Movement synchrony was higher in CC than DC dyads. Higher movement synchrony predicted reduced pain and increased trust in the clinician. Movement synchrony also formally mediated the group concordance effects on pain and trust. These findings increase our understanding of the role of nonverbal C-P communication on pain and related outcomes and suggest that interpersonal synchrony may be associated with better patient outcomes, independent of the specific treatment provided. Perspective This article demonstrates that movement synchrony in clinician-patient interactions is an unobtrusive measure related to their relationship quality, trust towards the clinician, and pain. These findings suggest that interpersonal synchrony may be associated with better patient outcomes, independent of the specific treatment provided.",2020,Movement synchrony was higher in CC than DC dyads.,['Participants (N=66'],[],"['pain and trust', 'interpersonal trust and perceived pain', 'Movement synchrony', 'pain']",[],[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",66.0,0.0401092,Movement synchrony was higher in CC than DC dyads.,"[{'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Goldstein', 'Affiliation': 'Institute of Cognitive Science, University of Colorado, Boulder, CO, USA; The School of Public Health, University of Haifa, Israel.'}, {'ForeName': 'Elizabeth A Reynolds', 'Initials': 'EAR', 'LastName': 'Losin', 'Affiliation': 'Department of Psychology, University of Miami, FL, USA.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Anderson', 'Affiliation': 'Department of Psychology, University of Miami, FL, USA.'}, {'ForeName': 'Victoria R', 'Initials': 'VR', 'LastName': 'Schelkun', 'Affiliation': 'Department of Psychological and Brain Sciences, Dartmouth College, NH, USA.'}, {'ForeName': 'Tor D', 'Initials': 'TD', 'LastName': 'Wager', 'Affiliation': 'Department of Psychological and Brain Sciences, Dartmouth College, NH, USA; Department of Psychology and Neuroscience, University of Colorado, Boulder, CO, USA. Electronic address: tor.d.wager@dartmouth.edu.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2020.03.001']
2639,32544700,Time course of drug-related treatment-emergent adverse side effects of brivaracetam.,"OBJECTIVE


Treatment-emergent adverse events (TEAEs) in clinical trials are typically reported for the full duration of the treatment period including titration and maintenance. Drug-related central nervous system (CNS) TEAEs are common with antiseizure medications (ASMs) and can affect drug tolerability. In this report, we test the hypothesis that drug-related CNS TEAEs have early onset and decrease with time. Unlike prior ASM clinical trials, a novel design was used for brivaracetam (BRV) without initial drug titration allowing assessment of habituation to TEAEs separate from dose titration.
METHODS


Data were pooled from three studies (N01252 [NCT00490035], N01253 [NCT00464269], N01358 [NCT01261325]) in adult patients (≥16 years of age) with focal seizures receiving BRV adjunctive therapy. This post hoc analysis reports data on the prevalence and incidence of all drug-related CNS TEAEs and all TEAEs over time in patients who received BRV doses of 50-200 mg/day (without titration) vs. placebo during a 12-week treatment period.
RESULTS


A total of 1262 patients received the following: placebo (n = 459), BRV 50 mg/day (n = 200), BRV 100 mg/day (n = 353), and BRV 200 mg/day (n = 250). Both the incidence (p < .0001) and prevalence (p < .0001) of drug-related CNS TEAEs (all with frequency ≥ 5%) changed across time with peak TEAEs in week 1 then significantly reducing over the first 6 weeks for prevalence and the first 3 weeks for incidence.
CONCLUSIONS


Drug-related CNS TEAEs occurred early and substantially habituated over several weeks. TEAEs of ASMs might be better represented by division into early and late phases to guide clinician monitoring and patient expectations.",2020,"Both the incidence (p < .0001) and prevalence (p < .0001) of drug-related CNS TEAEs (all with frequency ≥ 5%) changed across time with peak TEAEs in week 1 then significantly reducing over the first 6 weeks for prevalence and the first 3 weeks for incidence.
","['1262 patients', 'adult patients (≥16\u202fyears of age) with focal seizures receiving BRV adjunctive therapy']","['Drug-related central nervous system (CNS', 'brivaracetam', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],1262.0,0.10034,"Both the incidence (p < .0001) and prevalence (p < .0001) of drug-related CNS TEAEs (all with frequency ≥ 5%) changed across time with peak TEAEs in week 1 then significantly reducing over the first 6 weeks for prevalence and the first 3 weeks for incidence.
","[{'ForeName': 'Kimford J', 'Initials': 'KJ', 'LastName': 'Meador', 'Affiliation': 'Department of Neurology and Neurological Sciences, Stanford University, Stanford, CA, USA. Electronic address: kmeador@stanford.edu.'}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Laloyaux', 'Affiliation': 'UCB Pharma, Brussels, Belgium. Electronic address: cedric.laloyaux@ucb.com.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Elmoufti', 'Affiliation': 'UCB Pharma, Raleigh, NC, USA. Electronic address: sami.elmoufti@ucb.com.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Gasalla', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany. Electronic address: teresa.gasalla@ucb.com.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Fishman', 'Affiliation': 'UCB Pharma, Smyrna, GA, USA. Electronic address: jfishman@its.jnj.com.'}, {'ForeName': 'Melinda S', 'Initials': 'MS', 'LastName': 'Martin', 'Affiliation': 'UCB Pharma, Smyrna, GA, USA. Electronic address: melinda.martin@ucb.com.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Klein', 'Affiliation': 'Mid-Atlantic Epilepsy and Sleep Center, Bethesda, MD, USA. Electronic address: kleinp@epilepsydc.com.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107212']
2640,32544794,Acute aerobic exercise enhances pleasant compared to unpleasant visual scene processing.,"Although acute aerobic exercise benefits different aspects of emotional functioning, it is unclear how exercise influences the processing of emotional stimuli and which brain mechanisms support this relationship. We assessed the influence of acute aerobic exercise on valence biases (preferential processing of negative/positive pictures) by performing source reconstructions of participants' brain activity after they viewed emotional scenes. Twenty-four healthy participants (12 women) were tested in a randomized and counterbalanced design that consisted of three experimental protocols, each lasting 30 min: low-intensity exercise (Low-Int); moderate-intensity exercise (Mod-Int); and a seated rest condition (REST). After each of the protocols, participants viewed negative and positive pictures, during which event-related magnetic fields were recorded. Analyses revealed that exercise strongly impacted the valence processing of emotional scenes within a widely distributed left hemispheric spatio-temporal cluster between 190 and 310 ms after picture onset. Brain activity in this cluster showed that a negativity bias at REST (negative > positive picture processing) diminished after the Low-Int condition (positive = negative) and even reversed to a positivity bias after the Mod-Int condition (positive > negative). Thus, acute aerobic exercise of low and moderate intensities induces a positivity bias which is reflected in early, automatic processes.",2020,Analyses revealed that exercise strongly impacted the valence processing of emotional scenes within a widely distributed left hemispheric spatio-temporal cluster between 190 and 310 ms after picture onset.,"['Twenty-four healthy participants (12 women', ""participants' brain activity after they viewed emotional scenes""]","['Acute aerobic exercise enhances pleasant', 'lasting 30\xa0min: low-intensity exercise (Low-Int); moderate-intensity exercise (Mod-Int); and a seated rest condition (REST', 'acute aerobic exercise']","['valence processing of emotional scenes', 'Brain activity']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}]",24.0,0.139816,Analyses revealed that exercise strongly impacted the valence processing of emotional scenes within a widely distributed left hemispheric spatio-temporal cluster between 190 and 310 ms after picture onset.,"[{'ForeName': 'Tomasz S', 'Initials': 'TS', 'LastName': 'Ligeza', 'Affiliation': 'Psychophysiology Laboratory, Institute of Psychology, Jagiellonian University, Kraków, Poland. Electronic address: tomasz.ligeza@uj.edu.pl.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Maciejczyk', 'Affiliation': 'Department of Physiology and Biochemistry, Faculty of Physical Education and Sport, University of Physical Education, Kraków, Poland.'}, {'ForeName': 'Miroslaw', 'Initials': 'M', 'LastName': 'Wyczesany', 'Affiliation': 'Psychophysiology Laboratory, Institute of Psychology, Jagiellonian University, Kraków, Poland.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Wagner', 'Affiliation': 'Institute for Sports Science, University of Muenster, Muenster, Germany; Otto Creutzfeldt Center for Cognitive and Behavioral Neuroscience, University of Muenster, Muenster, Germany.'}, {'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Roesmann', 'Affiliation': 'Otto Creutzfeldt Center for Cognitive and Behavioral Neuroscience, University of Muenster, Muenster, Germany; Institute for Clinical Psychology, University of Siegen, Siegen, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Junghofer', 'Affiliation': 'Institute for Biomagnetism and Biosignalanalysis, University of Muenster, Muenster, Germany; Otto Creutzfeldt Center for Cognitive and Behavioral Neuroscience, University of Muenster, Muenster, Germany.'}]",Brain and cognition,['10.1016/j.bandc.2020.105595']
2641,32544956,Endoscopic Filling with Polyglycolic Acid Sheets and Fibrin Glue of Persistent Fistula after Esophagectomy.,"[Abstract] Background and study aims: Treatment of anastomotic leakage in reconstruction after esophagectomy remains challenging. This report presents a new endoscopic filling method for persistent fistula after conservative treatment of anastomotic leakage (PFACTAL) after anastomotic insuffiency.
PATIENTS AND METHODS


Ten of 14 patients with PFACTAL after esophagectomy underwent treatment with the present method in which polyglycolic acid (PGA) sheet and fibrin glue were endoscopically filled into the sight of anastomotic leakage (PAFi method) using own delivery tube and spread tube, respectively.
RESULTS


Every patient underwent jejunostomy, out of concern for nutrition. All patients with PFACTAL were cured using the PAFi method. Mean number of applications of the PAFi method was 1.7, and the period from the first and final use of the PAFi method to the resumption of oral intake was 31.6 and 14.7 days respectively.
CONCLUSIONS


The presented filling method offers a new endoscopic approach for PFACTAL after esophagoectomy.",2020,"This report presents a new endoscopic filling method for persistent fistula after conservative treatment of anastomotic leakage (PFACTAL) after anastomotic insuffiency.
",['Ten of 14 patients with PFACTAL after esophagectomy underwent treatment with the present method in which'],"['Endoscopic Filling with Polyglycolic Acid Sheets and Fibrin Glue of Persistent Fistula after Esophagectomy', 'anastomotic leakage', 'polyglycolic acid (PGA) sheet and fibrin glue were endoscopically filled into the sight of anastomotic leakage (PAFi method) using own delivery tube and spread tube, respectively']",['Mean number of applications of the PAFi method'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0032502', 'cui_str': 'Polyglycolide'}, {'cui': 'C0439643', 'cui_str': 'Sheets'}, {'cui': 'C0016004', 'cui_str': 'Autologous Fibrin Tissue Adhesive'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",14.0,0.0164148,"This report presents a new endoscopic filling method for persistent fistula after conservative treatment of anastomotic leakage (PFACTAL) after anastomotic insuffiency.
","[{'ForeName': 'Kousei', 'Initials': 'K', 'LastName': 'Tashiro', 'Affiliation': 'University of Miyazaki, Department of Surgery, Faculty of Medicine, Miyazaki, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Takeno', 'Affiliation': 'University of Miyazaki, Department of Surgery, Faculty of Medicine, Miyazaki, Japan.'}, {'ForeName': 'Fumiaki', 'Initials': 'F', 'LastName': 'Kawano', 'Affiliation': 'University of Miyazaki, Department of Surgery, Faculty of Medicine, Miyazaki, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Kitamura', 'Affiliation': 'University of Miyazaki, Department of Surgery, Faculty of Medicine, Miyazaki, Japan.'}, {'ForeName': 'Rouko', 'Initials': 'R', 'LastName': 'Hamada', 'Affiliation': 'University of Miyazaki Hospital, Center for Digestive Disease, Miyazaki, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Ikenoue', 'Affiliation': 'University of Miyazaki, Department of Surgery, Faculty of Medicine, Miyazaki, Japan.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Munakata', 'Affiliation': 'University of Miyazaki, Department of Surgery, Faculty of Medicine, Miyazaki, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nanashima', 'Affiliation': 'University of Miyazaki, Department of Surgery, Faculty of Medicine, Miyazaki, Japan.'}, {'ForeName': 'Kunihide', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'University of Miyazaki, Department of Surgery, Faculty of Medicine, Miyazaki, Japan.'}]",Endoscopy,['10.1055/a-1200-8199']
2642,32544970,[Sequential therapy for asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer].,"Abiraterone acetate (in combination with prednisone/prednisolone (abiraterone/P)), enzalutamide or docetaxel may all be used for the first-line treatment of asymptomatic or mildly symptomatic mCRPC. As treatment with docetaxel can result in the emergence of considerable adverse events, the less toxic substances abiraterone/P and enzalutamide are important alternatives. Apart from the safety and clinical effectiveness of these therapies, their optimal sequencing can play a significant role when choosing a mCRPC first-line therapy. Until recently, only retrospective trials were conducted, investigating the sequential use of abiraterone/P and enzalutamide in asymptomatic or mildly symptomatic mCRPC. However, the British Columbia Cancer Agency (BCCA) has now published results from a phase II randomised cross-over trial, which directly compared the safety and efficacy of abiraterone/P and enzalutamide in the first and second line.",2020,"As treatment with docetaxel can result in the emergence of considerable adverse events, the less toxic substances abiraterone/P and enzalutamide are important alternatives.","['asymptomatic or mildly symptomatic mCRPC', 'asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer']","['prednisone/prednisolone (abiraterone/P)), enzalutamide or docetaxel', 'docetaxel', 'abiraterone/P and enzalutamide', 'Abiraterone acetate']",[],"[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C2607886', 'cui_str': 'Abiraterone acetate'}]",[],,0.0179128,"As treatment with docetaxel can result in the emergence of considerable adverse events, the less toxic substances abiraterone/P and enzalutamide are important alternatives.","[{'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Miller', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Urologie, Berlin.'}]",Aktuelle Urologie,['10.1055/a-1036-1568']
2643,32545024,The effect of moringa leaves on pregnancy on growth and morbidity of 6-11 month.,"OBJECTIVE


This study was conducted to assess the effect of ML supplementation in women during pregnancy and lactation on growth and morbidity of 6-11 month-old infants.
METHOD


This study was an intervention study and followed with Cohort to the infants at 6-11 month-old. The subjects were pregnant women who were divided into three groups: a group who received ML powder (MLP, n=103), a group receiving ML extract (MLE, n=94), and a group consuming iron folic acid (IFA, n=111). Growth and morbidity measurement were assessed each month. The data was analyzed using ANOVA test and Chi-squares.
RESULTS


The study showed that prevalence of malnutrition at 6-11 month-old infants ranged from 7.8% to 14.9% for malnutrition and 2.6-7.1% of wasting and there were not significantly different among all age groups (p>0.05). Moreover, prevalence of stunting was 26.3-40.9% and there were significant difference among groups in some age periods. The prevalence of stunting was significantly lower in IFA compared to MLP and MLE groups (p<0.05). Diarrhea and upper respiratory infection were found but lower across the age periods (0.65-4.55%).
CONCLUSION


The study concluded that ML supplement in pregnant and lactating women could not protect infants from stunting.",2020,The prevalence of stunting was significantly lower in IFA compared to MLP and MLE groups (p<0.05).,"['infants at 6-11 month-old', 'subjects were pregnant women', 'pregnant and lactating women', 'women during pregnancy and lactation on growth and morbidity of 6-11 month-old infants']","['ML supplement', 'ML powder (MLP, n=103), a group receiving ML extract (MLE, n=94), and a group consuming iron folic acid', 'ML supplementation', 'MLP and MLE']","['prevalence of stunting', 'Diarrhea and upper respiratory infection', 'prevalence of malnutrition', 'Growth and morbidity measurement']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0357067', 'cui_str': 'Folic acid- and iron-containing product'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",,0.0303538,The prevalence of stunting was significantly lower in IFA compared to MLP and MLE groups (p<0.05).,"[{'ForeName': '', 'Initials': '', 'LastName': 'Sumiaty', 'Affiliation': 'Faculty of Public Health, Universitas Muslim, Indonesia. Electronic address: sumiatysudirman@gmail.com.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Tahir', 'Affiliation': 'Faculty of Public Health, Hasanuddin University, Indonesia.'}, {'ForeName': 'Bahar', 'Initials': 'B', 'LastName': 'Burhanuddin', 'Affiliation': 'Faculty of Public Health, Hasanuddin University, Indonesia.'}, {'ForeName': 'Jafar', 'Initials': 'J', 'LastName': 'Nurhaedar', 'Affiliation': 'Faculty of Public Health, Hasanuddin University, Indonesia.'}, {'ForeName': 'Hadju', 'Initials': 'H', 'LastName': 'Veni', 'Affiliation': 'Faculty of Public Health, Hasanuddin University, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.10.051']
2644,32545026,The effect of selenium and multiple micronutrient administration during periconception period on the level of malondialdehyde.,"OBJECTIVE


This study aimed to prove the effect of Selenium during periconception to the level of Malodialdehyde in pregnancy.
METHODS


This study was double blind, randomised, control community based trial design. The intervention group (10 periconception women) received Selenium in Multimicronutrient (MMN), while the control group (22 periconception women) given capsules containing Iron and Folic Acid. During preconceptional period, the capsules was given once a week, while in pregnant women was once a day. At the 12th and 20th weeks of pregnancy, selenium and MDA were measured. Statistical analysis using independent T-test, Paired T-Test and PLS analysis.
RESULTS


At the 12th weeks of pregnancy the level of MDA in Multimicronutrient group was 121.2ng/mL and IFA group was 1436ng/mL, and at the 20th weeks in MMN group was 108.4ng/Ml and IFA group was 199.6ng/mL. There was a no significant difference between MDA in two groups (p=0.424) at 12th week, but at 20th weeks MMN group had a significantly lower MDA levels (p=0.006) than IFA group.
CONCLUSION


The administration of selenium in MMN preparations since the preconception period has a better effect in reducing MDA levels compared to the IFA group.",2020,The administration of selenium in MMN preparations since the preconception period has a better effect in reducing MDA levels compared to the IFA group.,[],"['IFA', 'Selenium', 'selenium and multiple micronutrient', 'Selenium in Multimicronutrient (MMN), while the control group (22 periconception women) given capsules containing Iron and Folic Acid']","['level of malondialdehyde', 'MDA levels']",[],"[{'cui': 'C0281643', 'cui_str': ""incomplete Freund's adjuvant""}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}]",22.0,0.0933329,The administration of selenium in MMN preparations since the preconception period has a better effect in reducing MDA levels compared to the IFA group.,"[{'ForeName': 'Yustiyanty', 'Initials': 'Y', 'LastName': 'Monoarfa', 'Affiliation': 'Banggai District Health Office, Luwuk, Indonesia. Electronic address: ymonoarfa@gmail.com.'}, {'ForeName': 'Erry', 'Initials': 'E', 'LastName': 'Gumilar', 'Affiliation': 'Department of Fetomaternal, Faculty of Medicine, Soetomo General Hospital, Universitas Airlangga, Surabaya, Indonesia.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Widasari', 'Affiliation': 'Faculty of Medicine, Universitas Pembangunan Nasional Veteran, Jakarta, Indonesia.'}, {'ForeName': 'Rahayu', 'Initials': 'R', 'LastName': 'Yekti', 'Affiliation': 'Faculty of Medicine, Universitas Kristen Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Anang S', 'Initials': 'AS', 'LastName': 'Otoluwa', 'Affiliation': 'Banggai District Health Office, Luwuk, Indonesia.'}, {'ForeName': 'Abd Razak', 'Initials': 'AR', 'LastName': 'Thaha', 'Affiliation': 'Department of Public Health Nutrition, Faculty of Public Health, Universitas Hasanuddin, Makassar, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.10.053']
2645,32545075,The effect of back massage EPRO method on blood pressure in hypertension patients.,"OBJECTIVES


The purpose of this study was to see of the back massage EPRO (Effleurage Pressure Rotation) method on blood pressure in hypertension patients.
METHOD


This is a quantitative quazi experiment design study using a pre and post test design without control design to provide Back Massage EPRO Method for respondents who use mild hypertension, then used T-test analyze to see the combination of back massage EPRO method to the risk of hypertension and then described according to the results obtained.
RESULTS


There was a significant difference in systolic blood pressure after back massage with a p value<0.05 (p=0.014), the average difference in post and pre intervention was -1.20, while the average systolic blood pressure before intervention was 125.2 and after the intervention was 124.0. There is also a significant difference in diastolic blood pressure after back massage with a p value<0.05 (p=0.00), the average difference in post and pre-intervention was -6.60. The average diastolic blood pressure before intervention was 91.0 and after the intervention was 84.4.
CONCLUSION


Back Massage EPRO method is very influential on reducing blood pressure in both systole and diastole.",2020,"There was a significant difference in systolic blood pressure after back massage with a p value<0.05 (p=0.014), the average difference in post and pre intervention was -1.20, while the average systolic blood pressure before intervention was 125.2 and after the intervention was 124.0.","['hypertension patients', 'respondents who use mild hypertension']","['back massage EPRO (Effleurage Pressure Rotation', 'back massage EPRO method', 'Back Massage']","['blood pressure', 'average systolic blood pressure', 'average diastolic blood pressure', 'systolic blood pressure', 'diastolic blood pressure']","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}]","[{'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0203907', 'cui_str': 'Effleurage'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1282151', 'cui_str': 'Average systolic blood pressure'}, {'cui': 'C1282163', 'cui_str': 'Average diastolic blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",,0.0141574,"There was a significant difference in systolic blood pressure after back massage with a p value<0.05 (p=0.014), the average difference in post and pre intervention was -1.20, while the average systolic blood pressure before intervention was 125.2 and after the intervention was 124.0.","[{'ForeName': 'Ni Wayan', 'Initials': 'NW', 'LastName': 'Sridani', 'Affiliation': 'Faculty of Medicine, Tadulako University, Indonesia. Electronic address: niwayansridani@yahoo.com.'}, {'ForeName': 'Syamsiar', 'Initials': 'S', 'LastName': 'Russeng', 'Affiliation': 'Faculty of Public Health, Hasanuddin University, Indonesia.'}, {'ForeName': 'Rosmala', 'Initials': 'R', 'LastName': 'Nur', 'Affiliation': 'Faculty of Public Health, Tadulako University, Indonesia.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Fauzan', 'Affiliation': 'Faculty of Public Health, Tadulako University, Indonesia.'}, {'ForeName': 'Ratna', 'Initials': 'R', 'LastName': 'Devi', 'Affiliation': 'Faculty of Public Health, Tadulako University, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.10.035']
2646,32545088,The effect of counseling on adherence arv therapy in HIV/AIDS patient in H.A. sulthan daeng radja bulukumba regency.,"OBJECTIVE


This study aims to determine the effect of counseling on adherence to HIV/AIDS sufferers in RSUD. H. Sulthan Daeng Radja Bulukumba while undergoing therapy.
METHODS


This study used a quasi-experimental method with a nonrandomized control group pretest posttest design, Sampling by Purporsive sampling is 48 ODHA consisting of 2 groups, namely the intervention group and the control group, each 24 respondents. Data is analyzed descriptively and bivariately using the McNemar test.
RESULTS


Showed the highest respondent characteristics of the two study groups in the productive age group, 25-45 years old 91.6% with male and sex 79.2% married status 45.8%, the highest education level high school 70.8%. There are significant differences in the compliance of respondents after getting counseling at 93.8%.
CONCLUSION


Compliance of people with HIV has increased percentage both in the intervention group and the control group after counseling interventions in the intervention group 109% while the control group was 30%, after statistical tests, the effect of counseling was observed on the compliance of people with HIV with a p value <α. The improvement in the quality of life that can be felt by PLWHA while undergoing ARV therapy which is proven to be getting better.",2020,"Compliance of people with HIV has increased percentage both in the intervention group and the control group after counseling interventions in the intervention group 109% while the control group was 30%, after statistical tests, the effect of counseling was observed on the compliance of people with HIV with a p value",['HIV/AIDS patient in H.A. sulthan daeng radja bulukumba regency'],[],['quality of life'],"[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0334876,"Compliance of people with HIV has increased percentage both in the intervention group and the control group after counseling interventions in the intervention group 109% while the control group was 30%, after statistical tests, the effect of counseling was observed on the compliance of people with HIV with a p value","[{'ForeName': 'Sri', 'Initials': 'S', 'LastName': 'Wahyuni', 'Affiliation': 'Department of Epidemiology, Faculty of Public Health, Hasanuddin University, Indonesia.'}, {'ForeName': 'Andi', 'Initials': 'A', 'LastName': 'Zulkifli', 'Affiliation': 'Department of Epidemiology, Faculty of Public Health, Hasanuddin University, Indonesia. Electronic address: zulkifliabdullah@yahoo.com.'}, {'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Thamrin', 'Affiliation': 'Department of Health and Work Safety, Faculty of Public Health, Hasanuddin University, Indonesia.'}, {'ForeName': 'A Arsunan', 'Initials': 'AA', 'LastName': 'Arsin', 'Affiliation': 'Department of Epidemiology, Faculty of Public Health, Hasanuddin University, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.10.101']
2647,32545100,Logotherapy towards self-esteem of leprosy patients at Tadjuddin Chalid Hospital in Makassar City.,"OBJECTIVE


The purpose of this study was to determine the effect on self-esteem logotherapy leprosy patients in the Hospital Tadjuddin Chalid in Makassar.
METHODS


This study used a quasi-experimental. Samples were taken by nonrandom one group randomized design with accidental sampling method (18 lepers). Data collection used the Rosenberg Self Esteem Scale questionnaire. Data is normally distributed by analyzing paired t-test.
RESULTS


Characteristics of respondents in study group for male sex were 44.4%, female 55.5%, age 56-55 years 44.44% and elementary school 50%. Average self-esteem score before and after intervention, where mean±SD is 16.8±5.49 becomes 28.5±4.86 (p=0.000), which means there are differences average self-esteem score was significant before and after being given a Logotherapy Intervention.
CONCLUSION


Logotherapy needs to be recommended to be used as therapy to treat patients who experience low self-esteem.",2020,"Average self-esteem score before and after intervention, where mean±SD is 16.8±5.49 becomes 28.5±4.86 (p=0.000), which means there are differences average self-esteem score was significant before and after being given a Logotherapy Intervention.
","['leprosy patients at Tadjuddin Chalid Hospital in Makassar City', 'patients in the Hospital Tadjuddin Chalid in Makassar', 'Characteristics of respondents in study group for male sex were 44.4%, female 55.5%, age 56-55 years 44.44% and elementary school 50']",['self-esteem logotherapy leprosy'],"['Rosenberg Self Esteem Scale questionnaire', 'Average self-esteem score']","[{'cui': 'C0023343', 'cui_str': 'Leprosy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0204524', 'cui_str': 'Logotherapy'}, {'cui': 'C0023343', 'cui_str': 'Leprosy'}]","[{'cui': 'C0582666', 'cui_str': 'Rosenberg self-esteem scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0786091,"Average self-esteem score before and after intervention, where mean±SD is 16.8±5.49 becomes 28.5±4.86 (p=0.000), which means there are differences average self-esteem score was significant before and after being given a Logotherapy Intervention.
","[{'ForeName': 'Nurpatwa Wilda', 'Initials': 'NW', 'LastName': 'Ningsi', 'Affiliation': 'Epidemiology Departement, Public Health, Hasanuddin University, Indonesia. Electronic address: nurfatwawilda@gmail.com.'}, {'ForeName': 'Andi', 'Initials': 'A', 'LastName': 'Zulkifli', 'Affiliation': 'Epidemiology Departement, Public Health, Hasanuddin University, Indonesia.'}, {'ForeName': 'Anwar', 'Initials': 'A', 'LastName': 'Mallongi', 'Affiliation': 'Environmental Health and Safety Department, Public Health, Hasanuddin University, Indonesia.'}, {'ForeName': 'Aminuddin', 'Initials': 'A', 'LastName': 'Syam', 'Affiliation': 'Nutrition Department, Public Health, Hasanuddin University, Indonesia.'}, {'ForeName': 'Lalu Muhammad', 'Initials': 'LM', 'LastName': 'Saleh', 'Affiliation': 'Occupational Health and Safety Department, Public Health, Hasanuddin University, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.10.111']
2648,32545108,Effect of education media on improvement visual acetate acid inspection at Sudiang community health center.,"OBJECTIVE


The purpose of increasing knowledge, maternal attitudes about cervical cancer and the inspection of Visual Acetate.
METHODS


This is Quasi Experimental research method with non-randomized prepost-test group design. Subjects were conducted in the Papuan smear examination. Selection of samples used was purposive sampling technique with 25 respondents for each audio-visual and leaflet group. Health education uses audio-visual media and leaflets. Data was processed using Wilcoxon, and Mann-Whitney test.
RESULTS


Health education using audio visuals and leaflet information were able to provide knowledge levels, attitudes, and visual acetic acid inspection measures (p=0.00 and 0.00) both before and after treatment. There are differences in KAA between audio-visual and leaflet group for KAA p<0.05.
CONCLUSION


Study proves use of effective audio-visual media for health education activities in increasing knowledge, maternal attitudes about cervical cancer and visual acetic acid) inspection measures.",2020,"There are differences in KAA between audio-visual and leaflet group for KAA p<0.05.
",['at Sudiang community health center'],['education media'],"['improvement visual acetate acid inspection', 'knowledge levels, attitudes, and visual acetic acid inspection measures']","[{'cui': 'C0009469', 'cui_str': 'Satellite Centers'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0199219', 'cui_str': 'Inspection'}, {'cui': 'C0871796', 'cui_str': 'Knowledge level'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0000983', 'cui_str': 'Acetic Acid'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0193067,"There are differences in KAA between audio-visual and leaflet group for KAA p<0.05.
","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ulfa', 'Affiliation': 'Reproductive Health Department, Public Health, Hasanuddin University, Indonesia. Electronic address: rawnaenvi@gmail.com.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Stang', 'Affiliation': 'Biostatistics Department, Public Health, Hasanuddin University, Indonesia.'}, {'ForeName': 'Andi Mardiah', 'Initials': 'AM', 'LastName': 'Tahir', 'Affiliation': 'Obstetrics and Ginecology Department, Faculty of Medical, Indonesia.'}, {'ForeName': 'Anwar', 'Initials': 'A', 'LastName': 'Mallongi', 'Affiliation': 'Environmental Health Department, Public Health, Hasanuddin University, Indonesia.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Rachmat', 'Affiliation': 'Health Promotion and Behavioral Sciences Department, Public Health, Hasanuddin University, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.10.118']
2649,32545112,The effect of giving fish extract (Pujimin Plus) on intake of protein and hemoglobin hypoalbuminemic patients.,"OBJECTIVE


This study aimed to determine the effect of cork extract on albumin levels and protein intake in hypoalbuminemic patients at Wahidin Sudirohusodo Hospital.
METHODS


This study was a quasi-experimental study with a randomized controlled trial (RCT) design, then divided into 2 intervention and control groups each consisting of 17 people.
RESULTS


Data analysis showed that albumin level of intervention group 2.95±0.28 increased to 3.17±0.39 (p=0.011). In control group 2.93±0.27 decreased to 2.88±0.49 (p=0.527). For protein intake in intervention group 56.27±25.95 to 91.10±26.17 (p=0.002). In control group 42.26±13.78 to 54.66±17.62 (p=0.032). And for hemoglobin intervention group from 10.83±2.46 increased 11.30±1.65 but statistically not significant (p=0.345), while in control group 10.78±1.28 to 10.86±1.44 (p=0.765).
CONCLUSION


There was an effect of giving cork fish extract (Pujimin Plus) to albumin levels and protein intake in hypoalbuminemic patients.",2020,In control group 2.93±0.27 decreased to 2.88±0.49 (p=0.527).,"['17 people', 'hypoalbuminemic patients', 'hemoglobin hypoalbuminemic patients', 'hypoalbuminemic patients at Wahidin Sudirohusodo Hospital']","['hemoglobin intervention', 'giving cork fish extract (Pujimin Plus', 'giving fish extract (Pujimin Plus', 'cork extract']","['albumin levels and protein intake', 'albumin level']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0304066', 'cui_str': 'Cork'}, {'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0201838', 'cui_str': 'Albumin measurement'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",,0.038021,In control group 2.93±0.27 decreased to 2.88±0.49 (p=0.527).,"[{'ForeName': 'Moh Rizki', 'Initials': 'MR', 'LastName': 'Fauzan', 'Affiliation': 'Nutrition Department, Public Health, Hasanuddin University, Indonesia. Electronic address: mohammad.rizkifauzan@yahoo.co.id.'}, {'ForeName': 'Citra Kusumasari', 'Initials': 'CK', 'LastName': 'Dahlan', 'Affiliation': 'Nutrition Department, Public Health, Hasanuddin University, Indonesia.'}, {'ForeName': 'Nurpudji A', 'Initials': 'NA', 'LastName': 'Taslim', 'Affiliation': 'Department of Nutrition School of Medicine, Hasanuddin University, Indonesia.'}, {'ForeName': 'Aminuddin', 'Initials': 'A', 'LastName': 'Syam', 'Affiliation': 'Nutrition Department, Public Health, Hasanuddin University, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2020.03.009']
2650,32545128,"The effects of high-intensity interval training (HIIT) in improving VO 2  max football student activity unit, University of Musamus.","OBJECTIVE


This study aims to determine the effect of High-Intensity Interval Training (HIIT) in improving VO 2  Max in Football Students Activity Unit, University of Musamus.
METHOD


This research is an experimental study with one group pretest and posttest design research. The population in this study was Football Students Activity Unit, the University of Musamus, which numbered 22 students who were the subjects of the study. Data retrieval technique is by tests and measurements. The instrument used is a multi-stage fitness test (bleep test). The students were given HIIT; it carried out twice a week for four weeks. Analysis of the data used is using t-test at 0.05% as the significance level.
RESULT


Based on the results, the number of pretests showed on 39.6773. While at the posttest after there was an improvement, the number showed on 48.5863. Based on the results of data analysis on the hypothesis in the study, it was found that there was a significant effect of HIIT in improving VO 2  Max football student activity unit, University of Musamus, it was indicated by the score of t-count that higher than t-table (13.015>2.080).
CONCLUSION


There was a significant effect of the HIIT in improving football students' VO 2  of Max at University of Musamus.",2020,There was a significant effect of the HIIT in improving football students' VO 2  of Max at University of Musamus.,"['Football Students Activity Unit, University of Musamus', 'Football Students Activity Unit, the University of Musamus, which numbered 22 students who were the subjects of the study']","['high-intensity interval training (HIIT', 'High-Intensity Interval Training (HIIT']","['VO 2  Max football student activity unit, University of Musamus']","[{'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0041740', 'cui_str': 'University'}]",22.0,0.0149851,There was a significant effect of the HIIT in improving football students' VO 2  of Max at University of Musamus.,"[{'ForeName': 'Dilli Dwi', 'Initials': 'DD', 'LastName': 'Kuswoyo', 'Affiliation': 'Department of Physical Education Sport, Faculty of Education, Universitas Musamus, Merauke, Indonesia. Electronic address: kuswoyo_fkip@unmus.ac.id.'}, {'ForeName': 'Jori', 'Initials': 'J', 'LastName': 'Lahinda', 'Affiliation': 'Department of Physical Education Sport, Faculty of Education, Universitas Musamus, Merauke, Indonesia.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Syamsudin', 'Affiliation': 'Department of Physical Education Sport, Faculty of Education, Universitas Musamus, Merauke, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.10.130']
2651,32558624,Intragastric fructose administration interacts with emotional state in homeostatic and hedonic brain regions.,"Background:  Interoceptive properties of food may influence emotional state and its neural basis, as shown for fatty acids but remains unstudied for carbohydrates.  Objectives:  To study the effects of fructose and its interaction with sad emotion on brain activity in homeostatic and hedonic regions and investigate whether gut hormone responses can explain effects.  Design:  In 15 healthy subjects, brain activity for 40min after intragastric infusion of fructose (25g) or water was recorded using a cross-over pharmacological magnetic resonance imaging (phMRI) paradigm. Sad or neutral emotional states were induced by classical music and emotional facial expressions. Emotional state was assessed using the Self-Assessment Manikin. Blood samples were taken to assess gut hormone levels. Brain responses to fructose versus placebo, sad versus neutral emotion, and their interaction were analyzed over time in a single mask of  a priori  defined regions of interest at a voxel-level threshold of  p FWEcorrected   <0.05. Effects on emotion and hormones were tested using linear mixed models.  Results:  No main effects of fructose, emotion, or fructose-by-emotion interaction on emotional ratings were observed. Main effects of fructose, emotion and aninteraction effect were found on brain activity (medulla, midbrain, hypothalamus, basal ganglia, anterior insula, orbitofrontal cortex, anterior cingulate cortex and amygdala). An increase in circulating GLP-1 after fructose in neutral emotion was abolished during sad emotion (fructose-by-emotion-by-time,  p =0.041). Ghrelin levels were higher in sad emotion (time-by-emotion,  p =0.037).  Conclusions:  Emotional state interacts with brain and endocrine responses to intragastric infusion of 25 g of fructose, however such an effect was not found at behavioral level.  Trial registration:  ClinicalTrials.gov identifier: NCT02946983.",2020,"Ghrelin levels were higher in sad emotion (time-by-emotion,  p =0.037).  ",['15 healthy subjects'],"['fructose versus placebo, sad versus neutral emotion', 'fructose and its interaction with sad emotion', 'fructose (25g) or water was recorded using a cross-over pharmacological magnetic resonance imaging (phMRI) paradigm', 'Intragastric fructose']","['brain activity (medulla, midbrain, hypothalamus, basal ganglia, anterior insula, orbitofrontal cortex, anterior cingulate cortex and amygdala', 'Emotional state', 'brain activity', 'emotion and hormones', 'circulating GLP-1 after fructose in neutral emotion', 'Ghrelin levels', 'fructose, emotion, or fructose-by-emotion interaction on emotional ratings', 'Sad or neutral emotional states']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}]","[{'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0025148', 'cui_str': 'Medulla oblongata structure'}, {'cui': 'C0025462', 'cui_str': 'Midbrain structure'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0004781', 'cui_str': 'Basal ganglion structure'}, {'cui': 'C0228259', 'cui_str': 'Anterior insula'}, {'cui': 'C0152301', 'cui_str': 'Structure of orbital gyrus'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}]",15.0,0.0336829,"Ghrelin levels were higher in sad emotion (time-by-emotion,  p =0.037).  ","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Iven', 'Affiliation': 'Translational Research Center for Gastrointestinal Disorders, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Biesiekierski', 'Affiliation': 'Translational Research Center for Gastrointestinal Disorders, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Dongxing', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'Translational Research Center for Gastrointestinal Disorders, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Tack', 'Affiliation': 'Translational Research Center for Gastrointestinal Disorders, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Van Oudenhove', 'Affiliation': 'Translational Research Center for Gastrointestinal Disorders, University of Leuven, Leuven, Belgium.'}]",Nutritional neuroscience,['10.1080/1028415X.2020.1781326']
2652,32558709,Pitfalls in the Detection of Insulinomas With Glucagon-Like Peptide-1 Receptor Imaging.,"PURPOSE


Physiological pancreaticoduodenal uptake of radiolabeled exendin-4 in Brunner glands of the proximal duodenum is the most common pitfall for false interpretation of glucagon-like peptide-1 receptor (GLP-1R) imaging. The aim of this study was to analyze the pancreaticoduodenal uptake in GLP-1R PET/CT and SPECT/CT images and to identify additional potential reading pitfalls in patients with suspected insulinoma.
METHODS


A post hoc analysis of a prospective study, including 52 consecutive patients, was performed. All patients underwent 1 Ga-exendin-4 PET/CT and 2 In-exendin-4 SPECT/CT scans (4 and 72 hours postinjection) in a randomized crossover order. Three board-certified nuclear medicine physicians read all scans independently. They were unaware of other results. Reference standard was surgery with histopathological confirmation of an insulinoma/nesidioblastosis and normalization of blood glucose levels after surgery.
RESULTS


There were no false-positive readings. However, there were a number of false-negative PET/CT and SPECT/CT readings, respectively: (1) due to false interpretation of uptake in the pancreaticoduodenal region (falsely interpreted as physiological uptake in Brunner glands instead of an insulinoma in 0.6% vs 9.0%), (2) due to ectopic insulinoma (0% vs 2.6%), (3) due to small insulinoma (1.9% vs 5.1%), (4) due to insulinoma overlap with kidneys (1.9% vs 4.5%), and (5) due to nesidioblastosis (0.6% and 1.9%). Pitfalls were identified in all GLP-1R PET/CT and SPECT/CT scans.
CONCLUSIONS


Peripancreatic uptake, small size of an insulinoma, insulinoma overlap with kidneys, and presence of nesidioblastosis are potential pitfalls in GLP-1R imaging, which can lead to false reading results.",2020,There were no false-positive readings.,"['patients with suspected insulinoma', '52 consecutive patients, was performed']",['GLP-1R PET/CT and SPECT/CT images'],"['blood glucose levels', 'ectopic insulinoma']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0021670', 'cui_str': 'Insulinoma'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0378073', 'cui_str': 'GLP-1R Receptor'}, {'cui': 'C1699633', 'cui_str': 'Positron emission tomography with computed tomography'}, {'cui': 'C3472245', 'cui_str': 'Single photon emission computed tomography with computed tomography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]","[{'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0340464', 'cui_str': 'Ectopic beats'}, {'cui': 'C0021670', 'cui_str': 'Insulinoma'}]",52.0,0.0465109,There were no false-positive readings.,"[{'ForeName': 'Kwadwo', 'Initials': 'K', 'LastName': 'Antwi', 'Affiliation': 'From the Clinic of Radiology and Nuclear Medicine.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Hepprich', 'Affiliation': 'Division of Endocrinology, Diabetology and Metabolism, University Hospital Basel.'}, {'ForeName': 'Natasha A', 'Initials': 'NA', 'LastName': 'Müller', 'Affiliation': 'Faculty of Clinical Medicine, University of Basel, Basel.'}, {'ForeName': 'Jean Claude', 'Initials': 'JC', 'LastName': 'Reubi', 'Affiliation': 'Division of Cell Biology and Experimental Cancer Research, Institute of Pathology, University of Bern, Bern.'}, {'ForeName': 'Melpomeni', 'Initials': 'M', 'LastName': 'Fani', 'Affiliation': 'From the Clinic of Radiology and Nuclear Medicine.'}, {'ForeName': 'Christof', 'Initials': 'C', 'LastName': 'Rottenburger', 'Affiliation': 'From the Clinic of Radiology and Nuclear Medicine.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Nicolas', 'Affiliation': 'From the Clinic of Radiology and Nuclear Medicine.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Kaul', 'Affiliation': 'From the Clinic of Radiology and Nuclear Medicine.'}, {'ForeName': 'Emanuel R', 'Initials': 'ER', 'LastName': 'Christ', 'Affiliation': 'Division of Endocrinology, Diabetology and Metabolism, University Hospital Basel.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Wild', 'Affiliation': 'From the Clinic of Radiology and Nuclear Medicine.'}]",Clinical nuclear medicine,['10.1097/RLU.0000000000003124']
2653,32558726,Enrollment in the Zoster Eye Disease Study.,"PURPOSE


To present the results of a survey of the Zoster Eye Disease Study (ZEDS) investigators regarding barriers to the enrollment of study participants and approaches to overcome them.
METHODS


ZEDS is a multicenter randomized clinical trial supported by the National Eye Institute to determine whether prolonged suppressive valacyclovir reduces the complications of herpes zoster ophthalmicus (HZO), relative to placebo. Enrollment of study participants is currently far below expectations. An institutional review board-approved anonymous internet survey was conducted of ZEDS investigators to study their experiences and opinions regarding barriers to enrollment and various approaches to overcome them.
RESULTS


The overall survey response rate was 54% (79/145). Only 29% (23/79) agreed that it is easy to enroll study participants. Regarding patient barriers, 69% (55/79) agreed that HZO patients want to be treated with antiviral medication and 69% (54/78) agreed that HZO patients on antivirals do not want to be randomized. Regarding personal barriers facing investigators, 91% (72/79) agreed that antivirals are effective and 100% that the research questions ZEDS is designed to answer are very important. Fewer than 30% of respondents believed that steps taken to increase enrollment have been very helpful. Over half (54%, 42/78) believed that advertising on social media would be moderately or very effective.
CONCLUSIONS


Belief among ZEDS investigators that antivirals are effective, and the preference of patients to be treated with antivirals rather than be randomized in ZEDS, are major barriers to enrollment. New approaches to overcoming barriers are necessary to develop an evidence-based standard of care for treatment of HZO.",2020,"Over half (54%, 42/78) believed that advertising on social media would be moderately or very effective.
",[],"['suppressive valacyclovir', 'placebo']","['overall survey response rate', 'complications of herpes zoster ophthalmicus (HZO']",[],"[{'cui': 'C0205367', 'cui_str': 'Suppressive'}, {'cui': 'C0249458', 'cui_str': 'valacyclovir'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019364', 'cui_str': 'Herpes zoster ophthalmicus'}]",,0.069872,"Over half (54%, 42/78) believed that advertising on social media would be moderately or very effective.
","[{'ForeName': 'Elisabeth J', 'Initials': 'EJ', 'LastName': 'Cohen', 'Affiliation': 'Department of Ophthalmology, NYU Grossman School of Medicine, New York, NY.'}, {'ForeName': 'Bennie H', 'Initials': 'BH', 'LastName': 'Jeng', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Andrea B', 'Initials': 'AB', 'LastName': 'Troxel', 'Affiliation': 'Department of Population Health, NYU Grossman School of Medicine, New York, NY.'}, {'ForeName': 'Myeonggyun', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Department of Population Health, NYU Grossman School of Medicine, New York, NY.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Shakarov', 'Affiliation': 'NYU Grossman School of Medicine, New York, NY.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Hochman', 'Affiliation': 'NYU-HHC Clinical and Translational Science Institute, NYU Grossman School of Medicine, New York, NY.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Gillespie', 'Affiliation': 'Department of Population Health, NYU Grossman School of Medicine, New York, NY.'}]",Cornea,['10.1097/ICO.0000000000002392']
2654,32545579,Effects of Four-Week Rehabilitation Program on Hemostasis Disorders in Patients with Spinal Cord Injury.,"BACKGROUND


Patients with spinal cord injury (SCI) exhibit hemostasis disorders. This study aims at assessing the effects of a 4-week rehabilitation program on hemostasis disorders in patients with SCI.
METHODS


Seventy-eight in-patients undergoing a 4-week rehabilitation were divided into three groups based on time elapsed since SCI: I (3 weeks-3 months), II (3-6 months), and III (>6 months). Tissue factor (TF), tissue factor pathway inhibitor (TFPI), thrombin-antithrombin complex (TAT) and D-dimer levels, antithrombin activity (AT), and platelet count (PLT) were measured on admission and after rehabilitation.
RESULTS


Rehabilitation resulted in an increase in TF in group III ( p  < 0.050), and decrease in TFPI ( p  < 0.022) and PLT ( p  < 0.042) in group II as well as AT in group I ( p  < 0.009). Compared to control group without SCI, TF, TFPI, and TAT were significantly higher in all SCI groups both before and after rehabilitation. All SCI groups had elevated D-dimer, which decreased after rehabilitation in the whole study group ( p  < 0.001) and group I ( p  < 0.001).
CONCLUSION


No decrease in activation of TF-dependent coagulation was observed after a 4-week rehabilitation regardless of time elapsed since SCI. However, D-dimer levels decreased significantly, which may indicate reduction of high fibrinolytic potential, especially when rehabilitation was done <3 months after SCI.",2020,No decrease in activation of TF-dependent coagulation was observed after a 4-week rehabilitation regardless of time elapsed since SCI.,"['patients with SCI.\nMETHODS\n\n\nSeventy-eight in-patients undergoing a 4-week rehabilitation', 'Patients with spinal cord injury (SCI) exhibit hemostasis disorders', 'Patients with Spinal Cord Injury']","['4-week rehabilitation program', 'Four-Week Rehabilitation Program']","['PLT', 'TF', 'hemostasis disorders', 'Tissue factor (TF), tissue factor pathway inhibitor (TFPI), thrombin-antithrombin complex (TAT) and D-dimer levels, antithrombin activity (AT), and platelet count (PLT', 'TFPI', 'activation of TF-dependent coagulation', 'Hemostasis Disorders', 'SCI, TF, TFPI, and TAT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0040048', 'cui_str': 'Thromboplastin'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0164707', 'cui_str': 'Tissue factor pathway inhibitor'}, {'cui': 'C0052128', 'cui_str': 'Thrombin-antithrombin complex'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0200416', 'cui_str': 'Antithrombin III assay'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}]",,0.0100283,No decrease in activation of TF-dependent coagulation was observed after a 4-week rehabilitation regardless of time elapsed since SCI.,"[{'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Mackiewicz-Milewska', 'Affiliation': 'Department of Rehabilitation, Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz, 85-094 Bydgoszcz, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Cisowska-Adamiak', 'Affiliation': 'Department of Rehabilitation, Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz, 85-094 Bydgoszcz, Poland.'}, {'ForeName': 'Danuta', 'Initials': 'D', 'LastName': 'Rość', 'Affiliation': 'Department of Pathophysiology, Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz, 85-094 Bydgoszcz, Poland.'}, {'ForeName': 'Iwona', 'Initials': 'I', 'LastName': 'Głowacka-Mrotek', 'Affiliation': 'Department of Rehabilitation, Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz, 85-094 Bydgoszcz, Poland.'}, {'ForeName': 'Iwona', 'Initials': 'I', 'LastName': 'Świątkiewicz', 'Affiliation': 'Department of Cardiology and Internal Medicine, Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz, 85-094 Bydgoszcz, Poland.'}]",Journal of clinical medicine,['10.3390/jcm9061836']
2655,32545583,Effectiveness of Percutaneous Electrolysis in Supraspinatus Tendinopathy: A Single-Blinded Randomized Controlled Trial.,"Supraspinatus tendinopathy is one of the most common causes of shoulder pain. Many studies support conservative treatments such as exercise, trigger point dry needling or corticosteroid injections. Otherwise, a minimally invasive approach with percutaneous electrolysis (PE) has also been used successfully in shoulder pain, although evidence about its long-term effects is scarce. The aim of this trial was to determine the effects of PE on supraspinatus tendinopathy compared with trigger point dry needling (TDN). Thirty-six patients with supraspinatus tendinopathy were randomly assigned to either a PE group ( n  = 18) or a TDN group ( n  = 18). Both groups also performed eccentric exercises. The main outcome to be measured was the Numerical Pain Rating Scale (NPRS), but the shoulder range of motion (ROM) and trigger point pressure pain threshold (PPT) were also considered. A one-year follow-up was conducted. Significant differences favoring the PE group were found regarding pain at one-year follow-up ( p  = 0.002). The improvement achieved in the PE group was greater in the NPRS ( p  < 0.001), proximal PPT, middle PPT, distal PPT (all  p  < 0.001) and ranges of movement. PE seems to be more effective than TDN in relieving pain and improving ROM and PPT supraspinatus values in patients with supraspinatus tendinopathy, both right after treatment and at one-year follow-up.",2020,"PE seems to be more effective than TDN in relieving pain and improving ROM and PPT supraspinatus values in patients with supraspinatus tendinopathy, both right after treatment and at one-year follow-up.","['Thirty-six patients with supraspinatus tendinopathy', 'Supraspinatus Tendinopathy']","['TDN', 'eccentric exercises', 'PE', 'percutaneous electrolysis (PE', 'Percutaneous Electrolysis', 'trigger point dry needling (TDN']","['NPRS', 'proximal PPT, middle PPT, distal PPT', 'Numerical Pain Rating Scale (NPRS), but the shoulder range of motion (ROM) and trigger point pressure pain threshold (PPT', 'pain', 'relieving pain and improving ROM and PPT supraspinatus values']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0584869', 'cui_str': 'Supraspinatus muscle structure'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}]","[{'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0013829', 'cui_str': 'Electrolysis - action'}]","[{'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0032334', 'cui_str': 'podofilox'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0575545', 'cui_str': 'Shoulder joint - range of movement'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0584869', 'cui_str': 'Supraspinatus muscle structure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",36.0,0.118885,"PE seems to be more effective than TDN in relieving pain and improving ROM and PPT supraspinatus values in patients with supraspinatus tendinopathy, both right after treatment and at one-year follow-up.","[{'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Rodríguez-Huguet', 'Affiliation': 'Department of Nursing and Physiotherapy, University of Cádiz, 11009 Cádiz, Spain. manuel.rodriguez@uca.es.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Góngora-Rodríguez', 'Affiliation': 'Policlínica Santa María Clinic, 11008 Cádiz, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Rodríguez-Huguet', 'Affiliation': 'Andalusian Regional Public Health Service Hospital of Jerez de la Frontera, 11407 Cadiz, Spain.'}, {'ForeName': 'Alfonso Javier', 'Initials': 'AJ', 'LastName': 'Ibañez-Vera', 'Affiliation': 'Department of Health Sciences, University of Jaén, Campus las Lagunillas, 23071 Jaen, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rodríguez-Almagro', 'Affiliation': 'Department of Health Sciences, University of Jaén, Campus las Lagunillas, 23071 Jaen, Spain.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Martín-Valero', 'Affiliation': 'Department of Physiotherapy, Faculty of Health Sciences, University of Málaga, 29071 Málaga, Spain.'}, {'ForeName': 'Ángeles', 'Initials': 'Á', 'LastName': 'Díaz-Fernández', 'Affiliation': 'Department of Health Sciences, University of Jaén, Campus las Lagunillas, 23071 Jaen, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Lomas-Vega', 'Affiliation': 'Department of Health Sciences, University of Jaén, Campus las Lagunillas, 23071 Jaen, Spain.'}]",Journal of clinical medicine,['10.3390/jcm9061837']
2656,32545600,"Variations in Values of State, Response Entropy and Haemodynamic Parameters Associated with Development of Different Epileptiform Patterns during Volatile Induction of General Anaesthesia with Two Different Anaesthetic Regimens Using Sevoflurane in Comparison with Intravenous Induct: A Comparative Study.","BACKGROUND AND OBJECTIVES


Raw electroencephalographic (EEG) signals are rarely used to monitor the depth of volatile induction of general anaesthesia (VIGA) with sevoflurane, even though EEG-based indices may show aberrant values. We aimed to identify whether response (RE) and state entropy (SE) variations reliably reflect the actual depth of general anaesthesia in the presence of different types of epileptiform patterns (EPs) in EEGs during induction of general anaesthesia.
MATERIALS AND METHODS


A randomized, prospective clinical study was performed with 60 patients receiving VIGA using sevoflurane with the increasing concentrations (group VIMA) or the vital capacity (group VCRII) technique or an intravenous single dose of propofol (group PROP). Facial electromyography (fEMG), fraction of inspired sevoflurane (FiAA), fraction of expired sevoflurane (FeAA), minimal alveolar concentration (MAC) of sevoflurane, RE and SE, and standard electroencephalographic evaluations were performed in these patients.
RESULTS


In contrast to periodic epileptiform discharges, erroneous SE and RE values in the patients' EEGs were associated with the presence of polyspikes (PS) and rhythmic polyspikes (PSR), which were more likely to indicate toxic depth rather than false emergence from anaesthesia with no changes in the FiAA, FeAA, and MAC of sevoflurane.
CONCLUSION


Calculated RE and SE values may be misleading during VIGA when EPs are present in patients' EEGs. During VIGA with sevoflurane, we recommend monitoring raw EEG data in scientific studies to correlate it with potentially erroneous RE and SE values and the end-tidal concentration of sevoflurane in everyday clinical practice, when monitoring raw EEG is not available, because they can mislead anaesthesiologists to reduce sevoflurane levels in the ventilation gas and result in unintentional true emergence from anaesthesia. Further studies are required to investigate the behaviour of EEG-based indices during rapid changes in sevoflurane concentrations at different stages of VIGA and the influence of polyspikes and rhythmic polyspikes on the transformation of EEG signals into a digital form.",2020,"In contrast to periodic epileptiform discharges, erroneous SE and RE values in the patients' EEGs were associated with the presence of polyspikes (PS) and rhythmic polyspikes (PSR), which were more likely to indicate toxic depth rather than false emergence from anaesthesia with no changes in the FiAA, FeAA, and MAC of sevoflurane.
","['60 patients receiving VIGA using sevoflurane with the increasing concentrations (group VIMA) or the', 'group PROP']","['sevoflurane', 'vital capacity (group VCRII) technique or an intravenous single dose of propofol', 'Sevoflurane']","['erroneous SE and RE values', 'presence of polyspikes (PS) and rhythmic polyspikes (PSR', 'Facial electromyography (fEMG), fraction of inspired sevoflurane (FiAA), fraction of expired sevoflurane (FeAA), minimal alveolar concentration (MAC) of sevoflurane, RE and SE, and standard electroencephalographic evaluations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443769', 'cui_str': 'Volatile agent'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0042834', 'cui_str': 'Vital capacity'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C3541364', 'cui_str': 'Erroneous'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0376522', 'cui_str': 'Entropy'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]",60.0,0.0448379,"In contrast to periodic epileptiform discharges, erroneous SE and RE values in the patients' EEGs were associated with the presence of polyspikes (PS) and rhythmic polyspikes (PSR), which were more likely to indicate toxic depth rather than false emergence from anaesthesia with no changes in the FiAA, FeAA, and MAC of sevoflurane.
","[{'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Stasiowski', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, 40-055 Katowice, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Duława', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Railway District Hospital Katowice, 40-055 Katowice, Poland.'}, {'ForeName': 'Izabela', 'Initials': 'I', 'LastName': 'Szumera', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, 40-055 Katowice, Poland.'}, {'ForeName': 'Radosław', 'Initials': 'R', 'LastName': 'Marciniak', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, 40-055 Katowice, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Niewiadomska', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health in Bytom, Medical University of Silesia, 40-055 Katowice, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Kaspera', 'Affiliation': 'Department of Neurosurgery, Regional Hospital in Sosnowiec, Faculty of Medical Sciences in Katowice, Medical University of Silesia, 40-055 Katowice, Poland.'}, {'ForeName': 'Lech', 'Initials': 'L', 'LastName': 'Krawczyk', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, 40-055 Katowice, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ładziński', 'Affiliation': 'Department of Neurosurgery, Regional Hospital in Sosnowiec, Faculty of Medical Sciences in Katowice, Medical University of Silesia, 40-055 Katowice, Poland.'}, {'ForeName': 'Beniamin Oskar', 'Initials': 'BO', 'LastName': 'Grabarek', 'Affiliation': 'Department of Clinical Trials, Maria Sklodowska-Curie National Research Institute of Oncology Krakow Branch, 31-115 Katowice, Poland.'}, {'ForeName': 'Przemysław', 'Initials': 'P', 'LastName': 'Jałowiecki', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, 40-055 Katowice, Poland.'}]",Brain sciences,['10.3390/brainsci10060366']
2657,32545655,Effect of C242T Polymorphism in the Gene Encoding the NAD(P)H Oxidase p22 phox  Subunit and Aerobic Fitness Levels on Redox State Biomarkers and DNA Damage Responses to Exhaustive Exercise: A Randomized Trial.,"NAD(P)H oxidases (NOXs) constitute a principal source of cellular reactive oxygen species (ROS) and contribute to exercise-induced ROS production in the skeletal muscle. Here, we aimed to investigate the effect of single-bout exhaustive exercise on redox state biomarkers and oxidative DNA damage based on the C242T polymorphism in the gene encoding NOXs subunit p22 phox  ( CYBA ) and aerobic fitness levels. We enrolled 220 healthy adults in their 20s (men,  n  = 110; women,  n  = 110), who were divided into CC genotype and T allele groups through the analysis of the  CYBA  C242T polymorphism. Furthermore, maximum oxygen uptake (VO 2 max) was evaluated to divide subjects into high fitness (HF; 70th percentile for aerobic fitness) and mid-range fitness (MF; 40-60th percentile for aerobic fitness) groups, with a total of 32 subjects assigned to four groups (eight subjects per group): CC genotype and HF group (CC + HF), CC genotype and MF group (CC + MF), T allele and HF group (T + HF), and T allele and MF group (T + MF). All subjects performed treadmill running exercise at 85% of VO 2 max until exhaustion. Plasma lactate, malondialdehyde (MDA), superoxide dismutase (SOD), and lymphocyte DNA damage (tail DNA percentage [TD], tail length [TL], and the tail moment [TM]) were measured in the blood samples obtained immediately before (IBE), immediately after (IAE), and 30 min after exercise (30 MAE). Plasma lactate levels, SOD activities, and lymphocyte DNA damage markers (TD, TL, and TM) were significantly increased at IAE than that at IBE and significantly decreased at 30 MAE ( p  < 0.05). All groups displayed increased plasma MDA levels at IAE rather than at IBE, with CC + MF being significantly higher than T + HF ( p  < 0.05); only the CC + HF and T + HF groups exhibited a significant reduction at 30 MAE ( p  < 0.05). Moreover, TL at IAE was significantly higher in the CC + MF group than in the T + HF group ( p  < 0.05), and significantly higher in the CC + MF and CC + HF groups than in the T + HF group at 30 MAE ( p  < 0.05). TM was significantly higher in the T + MF than in the T + HF group at IAE ( p  < 0.05) and that of CC + MF was significantly higher than CC + HF and T + HF values at IAE and 30 MAE ( p  < 0.05). These results suggest that single-bout exhaustive exercise could induce peripheral fatigue and the accumulation of temporary redox imbalance and oxidative DNA damage. Moreover, high aerobic fitness levels combined with the T allele may protect against exercise-induced redox imbalance and DNA damage.",2020,"Plasma lactate levels, SOD activities, and lymphocyte DNA damage markers (TD, TL, and TM) were significantly increased at IAE than that at IBE and significantly decreased at 30 MAE ( p  < 0.05).","['220 healthy adults in their 20s (men,  n  = 110; women,  n  = 110']","['C242T Polymorphism', 'treadmill running exercise', 'CC + MF', 'CC genotype and HF group (CC + HF), CC genotype and MF group (CC + MF), T allele and HF group (T + HF), and T allele and MF group (T + MF', 'single-bout exhaustive exercise']","['peripheral fatigue and the accumulation of temporary redox imbalance and oxidative DNA damage', 'plasma MDA levels', 'Plasma lactate, malondialdehyde (MDA), superoxide dismutase (SOD), and lymphocyte DNA damage (tail DNA percentage [TD], tail length [TL], and the tail moment [TM', 'Plasma lactate levels, SOD activities, and lymphocyte DNA damage markers (TD, TL, and TM', 'TM', 'TL at IAE', 'maximum oxygen uptake (VO 2 max']","[{'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C0012860', 'cui_str': 'DNA damage'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0039259', 'cui_str': 'Tail'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1272145', 'cui_str': 'Plasma lactate level'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0429693', 'cui_str': 'Maximum oxygen uptake'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",220.0,0.020247,"Plasma lactate levels, SOD activities, and lymphocyte DNA damage markers (TD, TL, and TM) were significantly increased at IAE than that at IBE and significantly decreased at 30 MAE ( p  < 0.05).","[{'ForeName': 'Su-Youn', 'Initials': 'SY', 'LastName': 'Cho', 'Affiliation': 'Exercise Physiology Laboratory, Department of Physical Education, Yonsei University, Seoul 03722, Korea.'}, {'ForeName': 'Wi-Young', 'Initials': 'WY', 'LastName': 'So', 'Affiliation': 'Sports and Health Care Major, College of Humanities and Arts, Korea National University of Transportation, Chungju-si 27469, Korea.'}, {'ForeName': 'Hee-Tae', 'Initials': 'HT', 'LastName': 'Roh', 'Affiliation': 'Department of Physical Education, College of Arts and Physical Education, Dong-A University, Busan 49315, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17124215']
2658,32027205,Blood volume and pain perception during finger prick capillary blood sampling: are all safety lancets equal?,"OBJECTIVES


This study aimed to assess various types of safety lancets in terms of blood volume and pain perception during capillary blood sampling, a routine finger-puncture procedure for obtaining a small amount of human blood for running various screening and diagnostic tests.
METHODS


Data were collected from 100 adult healthy volunteers following finger-puncture procedure. Four different types of safety lancets were tested (Acti-Lance, Prolance, Medlance Plus, and MediSafe Solo). Each type has its own versions, giving 16 different safety lancets in total.
RESULTS


A significant difference in the mean capillary blood volume was found between blade and needle equipped safety lancets. MediSafe Solo type lancet had no blade version, and hence its use was associated with the lowest mean collected capillary blood volume (42.4 μL). Acti-Lance and Medlance Plus type lancets had one blade version and the mean collected capillary blood volume was 82.2 and 99.0 μL, respectively. Prolance type lancet had two blade versions, and its use was associated with the highest mean capillary blood volume (118.3 μL). The level of pain intensity was evaluated as low by the majority of patients for all lancets. Medlance Plus was the least painful and Acti-Lance was the most painful type of safety lancet. On a 0-to-10 scale of pain, 75% of punctures were assessed by the participants at a level not exceeding 3 points.
CONCLUSIONS


This study suggests that although all investigated safety lancets achieve adequate performance regarding the necessary capillary blood volume to run a diagnostic of test, lancets equipped with blades differ significantly from those equipped with needles in terms of the mean obtained capillary blood volume. Further, although all devices produced relatively low levels of pain, the amount of pain caused by blade versions of safety lancets has been found to be higher than that of needle versions.
CLINICALTRIALS.GOV ID


NCT04001348. (https://clinicaltrials.gov/ct2/show/NCT04001348?term=NCT04001348&draw=2&rank=1).",2020,A significant difference in the mean capillary blood volume was found between blade and needle equipped safety lancets.,['100 adult healthy volunteers following finger-puncture procedure'],['Medlance'],"['Blood volume and pain perception', 'mean capillary blood volume', 'level of pain intensity', 'mean collected capillary blood volume']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0457575', 'cui_str': 'Finger stick'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",[],"[{'cui': 'C0005850', 'cui_str': 'Blood volume'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0232093', 'cui_str': 'Capillary blood volume'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",100.0,0.0210275,A significant difference in the mean capillary blood volume was found between blade and needle equipped safety lancets.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Serafin', 'Affiliation': 'Regulatory Affairs Department, HTL-Strefa S.A , Ozorków, Poland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Malinowski', 'Affiliation': 'Regulatory Affairs Department, HTL-Strefa S.A , Ozorków, Poland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Prażmowska-Wilanowska', 'Affiliation': 'Regulatory Affairs Department, HTL-Strefa S.A , Ozorków, Poland.'}]",Postgraduate medicine,['10.1080/00325481.2020.1717160']
2659,31003804,Smoke-Free Moms: Financial Rewards for Smoking Cessation by Low-Income Rural Pregnant Women.,"INTRODUCTION


Maternal smoking places the child at risk during pregnancy and postpartum. Most women who quit smoking do so early when they first learn of pregnancy. Few low-income women quit once they enter prenatal care. The purpose of this study is to test in a clinical prenatal care setting the effectiveness of the Smoke-Free Moms intervention, which provides pregnant women a series of financial incentives for smoking cessation.
STUDY DESIGN


A prospective nonrandomized controlled trial that collected control population data of smoking-cessation rates at each clincal visit during pregnancy and postpartum with usual smoking counseling in 2013-2014. In 2015-2016, the same data were collected during the implementation of the Smoke-Free Moms intervention of financial incentives. Data analysis occurred in 2017.
SETTING/PARTICIPANTS


Women who were smoking at the first prenatal visit at four federally qualified health centers in rural New Hampshire.
INTERVENTION


All women received 5A's smoking counseling from clinic staff. At each clinic visit, with point-of-care confirmed negative urinary cotinine, intervention women received gift cards.
MAIN OUTCOME MEASURES


Cotinine confirmed smoking cessation without relapse: (1) during pregnancy and (2) smoking cessation in both pregnancy and postpartum.
RESULTS


Of 175 eligible pregnant women enrolled, 134 women were followed to the postpartum visit (Intervention n=66, Control n=68). The quit rates during pregnancy did not differ between groups (Intervention 36.4%, Control 29.4%, p=0.46). However, significantly more intervention mothers quit and continued as nonsmokers postpartum (Intervention 31.8%, Control 16.2%, p=0.04). In a logistic regression model including baseline sociodemographic, depressed mood, stress, and readiness to quit items, confidence in being able to quit predicted both cessation outcomes. The financial incentive intervention was an independent predictor of cessation in pregnancy through postpartum.
CONCLUSIONS


Financial incentives with existing smoking-cessation counseling by staff in low-income clinical prenatal programs led to cessation that continued during the postpartum period. Further study in larger populations is indicated.",2019,"The quit rates during pregnancy did not differ between groups (Intervention 36.4%, Control 29.4%, p=0.46).","['Smoking Cessation by Low-Income Rural Pregnant Women', ""All women received 5A's smoking counseling from clinic staff"", '134 women were followed to the postpartum visit (Intervention n=66, Control n=68', 'collected control population data of smoking-cessation rates at each clincal visit during pregnancy and postpartum with usual smoking counseling in 2013-2014', 'Women who were smoking at the first prenatal visit at four federally qualified health centers in rural New Hampshire', 'pregnant women a series of financial incentives for smoking cessation', '175 eligible pregnant women enrolled']","['Smoke-Free Moms intervention', 'Smoke-Free Moms: Financial Rewards']","['Cotinine confirmed smoking cessation without relapse: (1) during pregnancy and (2) smoking cessation in both pregnancy and postpartum', 'quit rates during pregnancy']","[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1273715', 'cui_str': 'Advice on smoking'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032662', 'cui_str': 'Population Control'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C1827763', 'cui_str': 'Prenatal visit'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0027969', 'cui_str': 'New Hampshire'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C4517605', 'cui_str': '175'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1442163', 'cui_str': 'MoM'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}]","[{'cui': 'C0010194', 'cui_str': 'Cotinine'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]",134.0,0.0316502,"The quit rates during pregnancy did not differ between groups (Intervention 36.4%, Control 29.4%, p=0.46).","[{'ForeName': 'Ardis L', 'Initials': 'AL', 'LastName': 'Olson', 'Affiliation': 'Department of Pediatrics, Dartmouth Geisel School of Medicine, Hanover, New Hampshire; Department of Community and Family Medicine, Dartmouth Geisel School of Medicine, Hanover, New Hampshire. Electronic address: ardis.l.olson@dartmouth.edu.'}, {'ForeName': 'Maureen B', 'Initials': 'MB', 'LastName': 'Boardman', 'Affiliation': 'Department of Community and Family Medicine, Dartmouth Geisel School of Medicine, Hanover, New Hampshire.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Johnson', 'Affiliation': 'Department of Community and Family Medicine, Dartmouth Geisel School of Medicine, Hanover, New Hampshire.'}]",American journal of preventive medicine,['10.1016/j.amepre.2019.02.008']
2660,31246713,Cytokine and Sclerostin Response to High-Intensity Interval Running versus Cycling.,"PURPOSE


This study examined whether the exercise-induced changes in inflammatory cytokines differ between impact and no-impact high-intensity interval exercise, and whether they are associated with postexercise changes in sclerostin.
METHODS


Thirty-eight females (n = 19, 22.6 ± 2.7 yr) and males (n = 19, 22.3 ± 2.4 yr) performed two high-intensity interval exercise trials in random order (crossover design): running on a treadmill and cycling on a cycle ergometer. Trials consisted of eight repetitions of 1 min running or cycling at ≥90% maximal heart rate, separated by 1 min passive recovery intervals. Blood was collected preexercise and 5 min, 1 h, 24 h, and 48 h postexercise, and it was analyzed for serum levels of interleukins (IL-1β, IL-6, and IL-10), tumor necrosis factor alpha (TNF-α), and sclerostin.
RESULTS


Inflammatory cytokines significantly increased over time in both sexes with some differences between trials. Specifically, IL-1β significantly increased from pre- to 5 min after both trials (23%, P < 0.05), IL-6 increased 1 h after both trials (39%, P < 0.05), IL-10 was elevated 5 min after running (20%, P < 0.05) and 1 h after both running and cycling (41% and 64%, respectively, P < 0.05), and TNF-α increased 5 min after running (10%, P < 0.05). Sclerostin increased 5 min after both trials, with a greater increase in males than that in females (62 vs 32 pg·mL in running, P = 0.018; 63 vs 30 pg·mL in cycling, P = 0.004). In addition, sclerostin was significantly correlated with the corresponding changes in inflammatory cytokines, and 34% of the variance in its postexercise gain score (Δ) was explained by sex and the corresponding gain scores in TNF-α, which was the strongest predictor.
CONCLUSION


A single bout of either impact or no-impact high-intensity exercise induces changes in inflammatory cytokines, which are associated with the postexercise increase in sclerostin.",2019,"Sclerostin increased 5 min after both trials, with a greater increase in males than that in females (62 vs 32 pg·mL in running, P = 0.018; 63 vs 30 pg·mL in cycling, P = 0.004).","['Thirty-eight females (n = 19, 22.6 ± 2.7 yr) and males (n = 19, 22.3 ± 2.4 yr) performed two high-intensity interval exercise trials in random order (crossover design']",['running on a treadmill and cycling on a cycle ergometer'],"['Inflammatory cytokines', 'Cytokine and Sclerostin Response', 'IL-1β', 'TNF-α', 'postexercise gain score', 'IL-6', 'Sclerostin', 'IL-10', 'serum levels of interleukins (IL-1β, IL-6, and IL-10), tumor necrosis factor alpha (TNF-α), and sclerostin', 'inflammatory cytokines']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0242817', 'cui_str': 'Crossover Design'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}]","[{'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}]",,0.111232,"Sclerostin increased 5 min after both trials, with a greater increase in males than that in females (62 vs 32 pg·mL in running, P = 0.018; 63 vs 30 pg·mL in cycling, P = 0.004).","[{'ForeName': 'Rozalia', 'Initials': 'R', 'LastName': 'Kouvelioti', 'Affiliation': 'Faculty of Applied Health Sciences, Department of Kinesiology, Brock University, St. Catharines, ON, CANADA.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Kurgan', 'Affiliation': 'Faculty of Applied Health Sciences, Department of Kinesiology, Brock University, St. Catharines, ON, CANADA.'}, {'ForeName': 'Bareket', 'Initials': 'B', 'LastName': 'Falk', 'Affiliation': 'Faculty of Applied Health Sciences, Department of Kinesiology, Brock University, St. Catharines, ON, CANADA.'}, {'ForeName': 'Wendy E', 'Initials': 'WE', 'LastName': 'Ward', 'Affiliation': 'Faculty of Applied Health Sciences, Department of Kinesiology, Brock University, St. Catharines, ON, CANADA.'}, {'ForeName': 'Andrea R', 'Initials': 'AR', 'LastName': 'Josse', 'Affiliation': 'Faculty of Applied Health Sciences, Centre for Bone and Muscle Health, Brock University, St. Catharines, ON, CANADA.'}, {'ForeName': 'Panagiota', 'Initials': 'P', 'LastName': 'Klentrou', 'Affiliation': 'Faculty of Applied Health Sciences, Department of Kinesiology, Brock University, St. Catharines, ON, CANADA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002076']
2661,31291158,MOMSonLINE: Lessons Learned From a Feasibility RCT of Online Support for Mothers Bereaved by Perinatal Loss.,"Online support groups are popular for peer support, particularly for uncommon or stigmatized topics including pregnancy and infant loss. We conducted a randomized, controlled, 6-week feasibility study of three groups: an anonymous BabyCenter.com loss support group, a closed Facebook loss group, or a control group. Intervention arm mothers were asked to sign on to their support sites for 6 weeks. Participants completed regular surveys, text message surveys after each log-in, and a final semistructured phone interview. Thirty women were randomized to each arm of the study. Women reported preference for anonymous groups and found it empowering to support others, although many noted an emotional cost to reading postings. Tracking usage online was a major issue despite multiple strategies to collect these data. This pilot demonstrated feasibility of a randomized trial for online perinatal support but noted a critical need for more reliable methods to track usage.",2019,"Women reported preference for anonymous groups and found it empowering to support others, although many noted an emotional cost to reading postings.","['Mothers Bereaved by Perinatal Loss', 'Thirty women']","['anonymous BabyCenter.com loss support group, a closed Facebook loss group, or a control group']",[],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],30.0,0.0641797,"Women reported preference for anonymous groups and found it empowering to support others, although many noted an emotional cost to reading postings.","[{'ForeName': 'Katherine J', 'Initials': 'KJ', 'LastName': 'Gold', 'Affiliation': 'Department of Family Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Martha E', 'Initials': 'ME', 'LastName': 'Boggs', 'Affiliation': 'Department of Family Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Kavanaugh', 'Affiliation': ""Children's Hospital of Wisconsin, Milwaukee, WI, USA.""}]",Omega,['10.1177/0030222819861558']
2662,31382270,The Effects of Electric Fan Use Under Differing Resting Heat Index Conditions: A Clinical Trial.,,2019,,[],[],['Electric Fan Use Under Differing Resting Heat Index Conditions'],[],[],"[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0441039', 'cui_str': 'Fan'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",,0.0159258,,"[{'ForeName': 'Nathan B', 'Initials': 'NB', 'LastName': 'Morris', 'Affiliation': 'Thermal Ergonomics Laboratory, The University of Sydney, Sydney, Australia (N.B.M., T.E., L.H.).'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'English', 'Affiliation': 'Thermal Ergonomics Laboratory, The University of Sydney, Sydney, Australia (N.B.M., T.E., L.H.).'}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Hospers', 'Affiliation': 'Thermal Ergonomics Laboratory, The University of Sydney, Sydney, Australia (N.B.M., T.E., L.H.).'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Capon', 'Affiliation': 'Thermal Ergonomics Laboratory and School of Public Health, The University of Sydney, Sydney, Australia (A.C.).'}, {'ForeName': 'Ollie', 'Initials': 'O', 'LastName': 'Jay', 'Affiliation': 'Thermal Ergonomics Laboratory and Charles Perkins Centre, The University of Sydney, Sydney, Australia (O.J.).'}]",Annals of internal medicine,['10.7326/M19-0512']
2663,32549142,"Effect of a school-based intervention in eating habits among school children: quasi experimental study, Tunisia.","Objective The present study aimed to assess whether six months intervention program with parents' implication in primary schools is able to decrease morning snack consumption among children aged 6-12 years. Methods We carried out a quasi-experimental study with two groups of schoolchildren in the region of Sousse (Tunisia) from 2015 to 2016. One primary school in each group was selected. In each school, we randomly selected a sample size of schoolchildren and their parents. The intervention was based on healthy eating habits promotion. Results The consumption of morning snacks the day before data collection, reported by children, decreased significantly in post-intervention in both intervention and control groups. The decrease of consumption of morning snacks was significantly higher in intervention group (p=0.009). According to parents, the proportion of children who had the habit of eating morning snack decreased significantly from pre to post-intervention in intervention group (p<0.001). Conclusion A healthy environment should be created through effective school policies to prevent obesity.",2020,The decrease of consumption of morning snacks was significantly higher in intervention group (p=0.009).,"['children aged 6-12 years', 'eating habits among school children', 'quasi-experimental study with two groups of schoolchildren in the region of Sousse (Tunisia) from 2015 to 2016']",['school-based intervention'],"['habit of eating morning snack', 'consumption of morning snacks', 'morning snack consumption']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0016468', 'cui_str': 'Eating Habits'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",1.0,0.0253655,The decrease of consumption of morning snacks was significantly higher in intervention group (p=0.009).,"[{'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Ben Cheikh', 'Affiliation': 'Faculty of medicine of Sousse, University of Sousse, Sousse, Tunisia.'}, {'ForeName': 'Jihène', 'Initials': 'J', 'LastName': 'Maatoug', 'Affiliation': 'Faculty of medicine of Sousse, University of Sousse, Sousse, Tunisia.'}, {'ForeName': 'Rim', 'Initials': 'R', 'LastName': 'Ghammam', 'Affiliation': 'Faculty of medicine of Sousse, University of Sousse, Sousse, Tunisia.'}, {'ForeName': 'Firas', 'Initials': 'F', 'LastName': 'Chouikha', 'Affiliation': 'Department of Epidemiology -\xa0Sousse, University Hospital Center Farhat Hached, Sousse, Tunisia.'}, {'ForeName': 'Amal', 'Initials': 'A', 'LastName': 'Mallat', 'Affiliation': 'Department of Epidemiology -\xa0Sousse, University Hospital Center Farhat Hached, Sousse, Tunisia.'}, {'ForeName': 'Hassen', 'Initials': 'H', 'LastName': 'Ghannem', 'Affiliation': 'Faculty of medicine of Sousse, University of Sousse, Sousse, Tunisia.'}]",International journal of adolescent medicine and health,['10.1515/ijamh-2018-0206']
2664,32549143,Perception of body image and its association with Body Mass Index (BMI) among college girls in Puducherry.,"Introduction and Objectives Adolescence is a transition stage when girls start developing positive and negative images regarding their body shape and appearance. It is a period where there is a constant urge among females to get a skinny and slim body shape. These distinguished unreal body shapes are influenced by the mass media and other common cultural idols. As it is important to know the factors affecting their perception, we aimed to determine the proportion of college girls who overestimate/underestimate their body image and also the influence of media, peers and parents in their perception of body image. Methods Total 510 students were selected between 18 and 21years. Standardized self -administered questionnaire such as the Figure Rating Scale (FRS) was used to determine the perception of body image among college girls. The FRS consists of schematic silhouette image of nine female from outmost slender to outmost overweight. Data regarding Sociodemographic, Anthropometry and effect of various factors influencing them were also collected. Results The present study showed that almost 60.2% of the college girls were having correct perception of their body shape. 21.2% of the college girls overestimated their body shape and 18.6% of college girls underestimated their body shape. The perception was significantly influenced by media, parents and peers. Conclusion The study concluded that almost two in five girls have a misconception of their body shape and it is more influenced by media and family, so encouraging adequate support from their parents and following healthy eating behavior is the need of the hour.",2020,21.2% of the college girls overestimated their body shape and 18.6% of college girls underestimated their body shape.,"['Methods Total 510 students were selected between 18 and 21years', 'college girls in Puducherry', 'college girls']",[],"['Rating Scale (FRS', 'Body Mass Index (BMI']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517800', 'cui_str': '510'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",510.0,0.0213312,21.2% of the college girls overestimated their body shape and 18.6% of college girls underestimated their body shape.,"[{'ForeName': 'Kumari', 'Initials': 'K', 'LastName': 'Puja', 'Affiliation': 'Department of Community Health Nursing, College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.'}, {'ForeName': 'Sathish', 'Initials': 'S', 'LastName': 'Rajaa', 'Affiliation': 'Department of Preventive and Social Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Ronur', 'Affiliation': 'Department of Community Health Nursing, College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.'}, {'ForeName': 'Mahalakshmy', 'Initials': 'M', 'LastName': 'Thulasingam', 'Affiliation': 'Department of Preventive and Social Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.'}]",International journal of adolescent medicine and health,['10.1515/ijamh-2018-0208']
2665,32549161,The effect of poetry reading on self-concept of primary adolescents.,"Objectives this study, regarding the importance and significance of self-concept in children's psychological health and considering the strong role of art in meeting psychological needs, aimed at investigating the effect of poetry reading on the self-concept of Adolescents. Methods This study was a classic experimental design of pre-test and posttest with two groups of intervention and control in the academic year 2016-2017. The research population included Adolescents who were studying in the city of Aq Qaladar in the province of Golestan, Iran. Sixty students. Data collecting tools included two questionnaires and ""Piers-Harris Children's Self-Concept"" scale. The experimental groups were provided with poetry reading in eight group sessions of 60 min for 4 weeks. The poems were approved by 10 teachers with 10 years of experience, and the supervisor. Finally, paired t-test and independent t-test were used to analyze data using SPSS 16 (SPSS Statistics is a software package used for interactive, or batched, statistical analysis). Results Adolescents self-concept in the control group was 57.9(4.33) and in the experimental group 62.4(4.28) out of 80 questionnaires which showed a significant difference between the two groups (p < 0.001). Which demonstrated the effectiveness of poetry reading on Adolescents self-concept. Conclusions Considering the positive impact of poetry reading on adolescent self-esteem, this intervention is recommended to improve adolescent self-esteem.",2020,Results Adolescents self-concept in the control group was 57.9(4.33) and in the experimental group 62.4(4.28) out of 80 questionnaires which showed a significant difference between the two groups (p < 0.001).,"[""children's psychological health"", 'primary adolescents', 'Adolescents who were studying in the city of Aq Qaladar in the province of Golestan, Iran', 'Sixty students', '10 teachers with 10 years of experience, and the supervisor']",['poetry reading'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0403172', 'cui_str': 'Supervisor'}]","[{'cui': 'C0032338', 'cui_str': 'Poetry'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]",[],,0.0212077,Results Adolescents self-concept in the control group was 57.9(4.33) and in the experimental group 62.4(4.28) out of 80 questionnaires which showed a significant difference between the two groups (p < 0.001).,"[{'ForeName': 'Sana', 'Initials': 'S', 'LastName': 'Shahrabady', 'Affiliation': 'Master of Psychiatric Nursing, School of Nursing, Iran Young Researchers and Elite Club, Gorgan Branch, Islamic Azad University, Gorgan, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Gholami', 'Affiliation': 'Department of Pediatric Nursing, School of Nursing & Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Afsharloo', 'Affiliation': 'MSc student of Community Health Nursing, Trabiat Modares University, Tehran, Iran.'}, {'ForeName': 'Shahla', 'Initials': 'S', 'LastName': 'Fakhreazizi', 'Affiliation': 'Community Health Nursing, Iranian Social Security organization, Zanjan Province Health Administration, Zanjan, Iran.'}, {'ForeName': 'Malhe', 'Initials': 'M', 'LastName': 'Izadi', 'Affiliation': 'Young Researchers and Elite Club, Aliabad Katoul Branch, Islamic Azad University, Aliabad Katoul, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Hojjati', 'Affiliation': 'Young Researchers and Elite Club, Aliabad Katoul Branch, Islamic Azad University, Aliabad Katoul, Iran.'}]",International journal of adolescent medicine and health,['10.1515/ijamh-2019-0216']
2666,32549168,Effect of Bhramari pranayama practice on simple reaction time in healthy adolescents - a randomized control trial.,"Objectives The improvement in the/reaction time is important, as it is an indicator of cognitive function. Therefore, there is a need, especially for adolescents in the form of techniques or courses that can improve the reaction time. Yoga was found to cause a better improvement in the health of the individuals. The present study intended to show the effects of Bhramari pranayama (Bhr.P) on reaction time in the healthy adolescents. Methods Of the 730 potential subjects screened, 520 apparently healthy adolescents randomly assigned to either the Bhr.P group (n-260) or control group (n-260). Bhr.P group practiced the bhramari pranayama for 3 days in a week for 6 months. The Auditory Reaction Time (ART) and the Visual Reaction Time (VRT) were assessed before and after Bhr.P pranayama practice. Results Bhr.P group shows significant shortening of response time in both VRT (from 267.13 ± 52.65 to 249.87 ± 39.41 ms) and ART (from 237.42 ± 48.12 to 227.91 ± 34.60 ms) after 6 months of Bhr.P practice. In control group subjects, no such significant changes were found (p > 0.05). Conclusions Shortening of RT implies an improvement in the information processing and reflexes. This beneficial effect of Bhr.P on reaction time can be used for improving cognitive function in the adolescents for their academic performances.",2020,The Auditory Reaction Time (ART) and the Visual Reaction Time (VRT) were assessed before and after Bhr.,"['730 potential subjects screened, 520 apparently healthy adolescents randomly assigned to either the Bhr', 'healthy adolescents']","['Bhramari pranayama practice', 'VRT', 'Bhramari pranayama']","['response time', 'reaction time', 'simple reaction time', 'cognitive function', 'Auditory Reaction Time (ART) and the Visual Reaction Time (VRT']","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517803', 'cui_str': '520'}, {'cui': 'C0686747', 'cui_str': 'Well adolescent'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0004684', 'cui_str': 'Bahrain'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]",520.0,0.0215895,The Auditory Reaction Time (ART) and the Visual Reaction Time (VRT) were assessed before and after Bhr.,"[{'ForeName': 'Maheshkumar', 'Initials': 'M', 'LastName': 'Kuppusamy', 'Affiliation': 'Government Yoga and Naturopathy Medical college and Hospital, Chennai, 600106, India.'}, {'ForeName': 'Dilara', 'Initials': 'D', 'LastName': 'Kamaldeen', 'Affiliation': 'Department of Physiology, Sri Ramachandra Medical College and Research Institute, Chennai, India.'}, {'ForeName': 'Ravishankar', 'Initials': 'R', 'LastName': 'Pitani', 'Affiliation': 'Department of Community Medicine, Ramachandra Medical College and Research Institute, Chennai, India.'}, {'ForeName': 'Julius', 'Initials': 'J', 'LastName': 'Amaldas', 'Affiliation': 'Department of Biochemistry, Sri Balaji Dental College and Hospital, Bharath University, Chennai, India.'}, {'ForeName': 'Padmavathi', 'Initials': 'P', 'LastName': 'Ramasamy', 'Affiliation': 'Department of Physiology, Sri Ramachandra Medical College and Research Institute, Chennai, India.'}, {'ForeName': 'Poonguzhali', 'Initials': 'P', 'LastName': 'Shanmugam', 'Affiliation': 'Government Yoga and Naturopathy Medical College and Hospital, Chennai, India.'}, {'ForeName': 'Venkateswaran Sankaralingam', 'Initials': 'VS', 'LastName': 'Thirupathy', 'Affiliation': 'Department of Yoga, Government Yoga and Naturopathy Medical College and Hospital, Chennai, India.'}]",International journal of adolescent medicine and health,['10.1515/ijamh-2019-0244']
2667,32549196,Efficacy and Safety of Botulinum Toxin Type A on Persistent Myofascial Pain: A Randomized Clinical Trial.,"This study assessed the safety and efficacy of three different doses of BoNT-A for persistent myofascial pain (MFP). One hundred female subjects were randomly assigned into five groups ( n  = 20): oral appliance (OA), saline solution (SS) and three BoNT-A groups with different doses. Pain intensity and pressure pain threshold were evaluated up to 24 weeks after treatment. Adverse effects related to muscle contraction, masticatory performance, muscle thickness and mandibular bone volume were also assessed. Changes over time were compared within and between groups. The ""nparLD"" package and Wilcoxon signed-rank test were used to analyze the data. BoNT-A reduced pain intensity ( p  < 0.0001) and increased pressure pain threshold ( p  < 0.0001) for up to 24 weeks compared to the placebo. No differences were found between BoNT-A and OA at the last follow-up. A transient decline in masticatory performance ( p  < 0.05) and muscle contraction ( p  < 0.0001), and a decrease in muscle thickness ( p  < 0.05) and coronoid and condylar process bone volume ( p  < 0.05) were found as dose-related adverse effects of BoNT-A. Regardless of the dose, BoNT-A was as effective as OA on MFP. Notwithstanding, due to BoNT-A dose-related adverse effects, we suggest the use of low doses of BoNT-A in MFP patients that do not benefit from conservative treatments.",2020,A reduced pain intensity ( p  < 0.0001) and increased pressure pain threshold ( p  < 0.0001) for up to 24 weeks compared to the placebo.,"['Persistent Myofascial Pain', 'persistent myofascial pain (MFP', 'One hundred female subjects']","['placebo', 'Botulinum Toxin Type A', 'oral appliance (OA), saline solution (SS']","['Efficacy and Safety', 'masticatory performance', 'muscle contraction', 'pain intensity', 'pressure pain threshold', 'safety and efficacy', 'muscle thickness', 'coronoid and condylar process bone volume', 'Pain intensity and pressure pain threshold', 'muscle contraction, masticatory performance, muscle thickness and mandibular bone volume']","[{'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0553642', 'cui_str': 'Myofascial pain'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}]",100.0,0.166347,A reduced pain intensity ( p  < 0.0001) and increased pressure pain threshold ( p  < 0.0001) for up to 24 weeks compared to the placebo.,"[{'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'De la Torre Canales', 'Affiliation': 'Department of Prosthodontics and Periodontology, Piracicaba Dental School, University of Campinas, Sao Paulo 13414-903, Brazil.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Alvarez-Pinzon', 'Affiliation': 'Department of Prosthodontics and Periodontology, Piracicaba Dental School, University of Campinas, Sao Paulo 13414-903, Brazil.'}, {'ForeName': 'Victor Ricardo Manuel', 'Initials': 'VRM', 'LastName': 'Muñoz-Lora', 'Affiliation': 'Department of Prosthodontics and Periodontology, Piracicaba Dental School, University of Campinas, Sao Paulo 13414-903, Brazil.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Vieira Peroni', 'Affiliation': 'Department of Oral Diagnosis, Piracicaba Dental School, University of Campinas, Sao Paulo 13414-903, Brazil.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Farias Gomes', 'Affiliation': 'Department of Oral Diagnosis, Piracicaba Dental School, University of Campinas, Sao Paulo 13414-903, Brazil.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Sánchez-Ayala', 'Affiliation': 'Department of Dentistry, State University of Ponta Grossa, Paraná 84030-900, Brazil.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Haiter-Neto', 'Affiliation': 'Department of Oral Diagnosis, Piracicaba Dental School, University of Campinas, Sao Paulo 13414-903, Brazil.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Manfredini', 'Affiliation': 'Department of Dentistry, University of Siena, 53100 Siena, Italy.'}, {'ForeName': 'Célia Marisa', 'Initials': 'CM', 'LastName': 'Rizzatti-Barbosa', 'Affiliation': 'Department of Prosthodontics and Periodontology, Piracicaba Dental School, University of Campinas, Sao Paulo 13414-903, Brazil.'}]",Toxins,['10.3390/toxins12060395']
2668,32549208,Evaluation of Sleep Quality in a Disaster Evacuee Environment.,"We aimed to evaluate sleep and sleep-related physiological parameters (heart rate variability and glucose dynamics) among evacuees by experimentally recreating the sleep environment of evacuation shelters and cars. Nine healthy young male subjects participated in this study. Two interventions, modeling the sleep environments of evacuation shelters (evacuation shelter trial) and car seats (car trial), were compared with sleep at home (control trial). Physiological data were measured using portable two-channel electroencephalogram and electrooculogram monitoring systems, wearable heart rate sensors, and flash glucose monitors. Wake after sleep onset (WASO) and stage shift were greater in both intervention trials than the control trial, while rapid-eye movement (REM) latency and non-rapid eye movement (NREM) 1 were longer and REM duration was shorter in the evacuation shelter trial than the control trial. Glucose dynamics and power at low frequency (LF.p) of heart rate variability were higher in the car trial than in the control trial. It was confirmed that sleep environment was important to maintain sleep, and affected glucose dynamics and heart rate variability in the experimental situation.",2020,Glucose dynamics and power at low frequency (LF.p) of heart rate variability were higher in the car trial than in the control trial.,"['Nine healthy young male subjects', 'evacuees by experimentally recreating the sleep environment of evacuation shelters and cars']",[],"['glucose dynamics and heart rate variability', 'Glucose dynamics and power at low frequency (LF.p) of heart rate variability', 'REM duration', 'rapid-eye movement (REM) latency and non-rapid eye movement (NREM']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C3178959', 'cui_str': 'Evacuation Shelter'}, {'cui': 'C0004381', 'cui_str': 'Automobile'}]",[],"[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}]",9.0,0.0882766,Glucose dynamics and power at low frequency (LF.p) of heart rate variability were higher in the car trial than in the control trial.,"[{'ForeName': 'Hitomi', 'Initials': 'H', 'LastName': 'Ogata', 'Affiliation': 'Graduate School of Integrated Arts and Sciences, Hiroshima University, Hiroshima 739-8521, Japan.'}, {'ForeName': 'Momoko', 'Initials': 'M', 'LastName': 'Kayaba', 'Affiliation': 'Department of Somnology, Tokyo Medical University, Tokyo 160-0023, Japan.'}, {'ForeName': 'Miki', 'Initials': 'M', 'LastName': 'Kaneko', 'Affiliation': 'Graduate School of Engineering Science, Osaka University, Osaka 565-8531, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Ogawa', 'Affiliation': 'Graduate School of Integrated Arts and Sciences, Hiroshima University, Hiroshima 739-8521, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kiyono', 'Affiliation': 'Graduate School of Engineering Science, Osaka University, Osaka 565-8531, Japan.'}]",International journal of environmental research and public health,['10.3390/ijerph17124252']
2669,32549776,Effects of an eight-week exercise program on parameters of the lipid profile of female students.,"Background


Increased lipid levels are one of the major risk factors for the development of cardiovascular diseases. The aim of the current study was to evaluate the effect of short-term (8 weeks) aerobic exercise of moderate to vigorous intensity on lipid profile in young healthy females.
Methods


27 female students (mean age 20.5 ± 1 year) completed 8 weeks of aerobic training that included two exercise sessions of continuous aerobic activity of moderate intensity (running 35-60 min) and one exercise session with interval training of vigorous intensity. Intervention aerobic capacity and lipid profile were examined before and after the exercise.
Results


Exercise intervention has caused a decrease of low density lipoprotein levels per 9.8% (from 2.52 ± 0.47 to 2.27 ± 0.53 mmol/L; p < 0.001) and significant improvement of high density lipoprotein (HDL) levels per 22.7% (from 1.29 ± 0.24 to 1.59 ± 0.24 mmol/L; p < 0.001), total cholesterol/HDL ratio per 17.2 % and aerobic capacity (VO 2max ) per 3.8 % (43.9 ± 3.7 to 45.56 ± 3.63 mLO2/kg/min).
Conclusions


The results support the hypothesis that a short-term aerobic exercise intervention of moderate to vigorous intensity may have significant effects on blood lipid profile in young healthy females.",2020,"Results


Exercise intervention has caused a decrease of low density lipoprotein levels per 9.8% (from 2.52 ± 0.47 to 2.27 ± 0.53 mmol/L; p < 0.001) and significant improvement of high density lipoprotein (HDL) levels per 22.7% (from 1.29 ± 0.24 to 1.59 ± 0.24 mmol/L; p < 0.001), total cholesterol/HDL ratio per 17.2 % and aerobic capacity (VO 2max ) per 3.8 % (43.9 ± 3.7 to 45.56 ± 3.63 mLO2/kg/min).
","['female students', 'young healthy females', '27 female students (mean age 20.5 ± 1 year']","['eight-week exercise program', 'aerobic exercise intervention', 'short-term (8 weeks) aerobic exercise', 'aerobic training that included two exercise sessions of continuous aerobic activity of moderate intensity (running 35-60 min) and one exercise session with interval training of vigorous intensity']","['high density lipoprotein (HDL) levels', 'total cholesterol/HDL ratio', 'Intervention aerobic capacity and lipid profile', 'blood lipid profile', 'low density lipoprotein levels', 'lipid levels']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]","[{'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}]",27.0,0.0235776,"Results


Exercise intervention has caused a decrease of low density lipoprotein levels per 9.8% (from 2.52 ± 0.47 to 2.27 ± 0.53 mmol/L; p < 0.001) and significant improvement of high density lipoprotein (HDL) levels per 22.7% (from 1.29 ± 0.24 to 1.59 ± 0.24 mmol/L; p < 0.001), total cholesterol/HDL ratio per 17.2 % and aerobic capacity (VO 2max ) per 3.8 % (43.9 ± 3.7 to 45.56 ± 3.63 mLO2/kg/min).
","[{'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Juhas', 'Affiliation': 'University of Belgrade, Faculty of Sport and Physical Education, Belgrade.'}, {'ForeName': 'Branko', 'Initials': 'B', 'LastName': 'Skof', 'Affiliation': 'University of Ljubljana, Faculty of Sport, Ljubljana, Slovenia.'}, {'ForeName': 'Dejana', 'Initials': 'D', 'LastName': 'Popović', 'Affiliation': 'University of Belgrade, Faculty of Pharmacy, Clinical Center of Serbia.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Matić', 'Affiliation': 'University of Belgrade, Faculty of Sport and Physical Education, Belgrade.'}, {'ForeName': 'Nenad', 'Initials': 'N', 'LastName': 'Janković', 'Affiliation': 'University of Belgrade, Faculty of Sport and Physical Education, Belgrade.'}]",Journal of medical biochemistry,['10.2478/jomb-2019-0006']
2670,32549848,"Was Blind, But Now I See.",,2019,,[],[],[],[],[],[],,0.0560223,,"[{'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Benda', 'Affiliation': ''}]","Integrative medicine (Encinitas, Calif.)",[]
2671,32549898,Thickening of the axillary recess capsule on ultrasound correlates with magnetic resonance imaging signs of adhesive capsulitis.,"Objective


To correlate the thickness of the axillary recess capsule measured by ultrasound with magnetic resonance imaging signs of adhesive capsulitis in patients with shoulder pain.
Materials and methods


We prospectively evaluated 193 consecutive patients (141 women and 52 men, aged 40-69 years) with shoulder pain lasting 1-9 months from January 2015 to December 2016 who underwent shoulder ultrasound. All participants had routine shoulder ultrasound with additional measurement of axillary recess capsule thickness. After examinations, two groups were formed: negative ultrasound group, composed of patients with a capsule thickness of 2.0 mm or less, and positive ultrasound group, composed of individuals with a capsule thickness greater than 2.0 mm. All patients from the positive ultrasound group and 27 randomly chosen patients from the negative ultrasound group underwent shoulder magnetic resonance imaging.
Results


In all, 169/193 patients (88%) had an axillary recess capsule thickness of 2.0 mm or less (negative ultrasound group) and 24/193 patients (12%) had a capsule thickness greater than 2.0 mm (positive ultrasound group). Twenty-seven patients from negative ultrasound group (27/169) were randomly selected to undergo shoulder magnetic resonance imaging. None of them had magnetic resonance imaging criteria for adhesive capsulitis. All patients from positive ultrasound group (24/24) underwent shoulder magnetic resonance imaging and 23 of them (23/24) had magnetic resonance imaging signs of adhesive capsulitis, with a sensitivity of 100% and a specificity of 96%.
Conclusion


In patients with shoulder pain, a thickness greater than 2.0 mm of the axillary recess capsule measured by ultrasound correlates to magnetic resonance imaging signs of adhesive capsulitis with good sensitivity and specificity.",2019,"In all, 169/193 patients (88%) had an axillary recess capsule thickness of 2.0 mm or less (negative ultrasound group) and 24/193 patients (12%) had a capsule thickness greater than 2.0 mm (positive ultrasound group).","['patients with shoulder pain', 'Twenty-seven patients from negative ultrasound group (27/169', 'All participants had routine shoulder ultrasound with additional measurement of axillary recess capsule thickness', '193 consecutive patients (141 women and 52 men, aged 40-69 years) with shoulder pain lasting 1-9 months from January 2015 to December 2016 who underwent shoulder ultrasound']","['negative ultrasound group underwent shoulder magnetic resonance imaging', 'shoulder magnetic resonance imaging']","['axillary recess capsule thickness', 'capsule thickness', 'magnetic resonance imaging signs of adhesive capsulitis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0158300', 'cui_str': 'Capsulitis, Adhesive'}]",193.0,0.0848339,"In all, 169/193 patients (88%) had an axillary recess capsule thickness of 2.0 mm or less (negative ultrasound group) and 24/193 patients (12%) had a capsule thickness greater than 2.0 mm (positive ultrasound group).","[{'ForeName': 'Renato A', 'Initials': 'RA', 'LastName': 'Sernik', 'Affiliation': 'Department of Radiology, Hospital Sírio-Libanês, São Paulo, Brazil.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Vidal Leão', 'Affiliation': 'Department of Radiology, Hospital Sírio-Libanês, São Paulo, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Luis Bizetto', 'Affiliation': 'Department of Radiology, Hospital Sírio-Libanês, São Paulo, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Sanford Damasceno', 'Affiliation': 'Department of Radiology, Hospital Sírio-Libanês, São Paulo, Brazil.'}, {'ForeName': 'Natally', 'Initials': 'N', 'LastName': 'Horvat', 'Affiliation': 'Department of Radiology, Hospital Sírio-Libanês, São Paulo, Brazil.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Guido Cerri', 'Affiliation': 'Department of Radiology, Hospital Sírio-Libanês, São Paulo, Brazil.'}]","Ultrasound (Leeds, England)",['10.1177/1742271X19840063']
2672,32549983,The use of exhaled nitric oxide and peak expiratory flow to demonstrate improved breathability and antimicrobial properties of novel face mask made with sustainable filter paper and  Folium Plectranthii amboinicii  oil: additional option for mask shortage during COVID-19 pandemic.,"Background


Medical face masks are integral personal protective equipment against infectious airborne disease and become scarce during epidemic outbreaks such as COVID-19. A novel, sustainably manufactured face mask with antimicrobial and anti-inflammatory properties from oil of  Folium Plectranthii amboinicii  can be an effective alternative to internationally sold masks.
Methods


This prospective, randomized study assigned subjects (n=67) to either conventional surgical face mask or Lamdong Medical College (LMC) face mask for three hours. Fractional concentration of nitric oxide in exhaled breath ( F E NO ) and peak expiratory flow (PEF) was measured before and after mask use. Subjective reporting on respiratory symptoms was also analyzed. Masks were then incubated and analyzed for microorganism growth.
Results


Subjects assigned the LMC mask had a lowered  F E NO  ( p <0.05) compared to conventional face masks after mask wearing. Subjects with LMC mask use reported higher comfortability ( p <0.05), breathability ( p <0.05), and lower allergy symptoms ( p <0.05). The LMC mask has visually less microorganism growth in the cultured medium, measured by sterile ring radius.
Conclusions


The LMC face mask is a renewably manufactured personal protective tool with antibacterial capacity that can serve as an effective alternative to internationally sold surgical face mask during shortage of mask due to COVID-19.",2020,"Results


Subjects assigned the LMC mask had a lowered  F E NO  ( p <0.05) compared to conventional face masks after mask wearing.",['subjects (n=67) to either'],['conventional surgical face mask or Lamdong Medical College (LMC) face mask'],"['lower allergy symptoms', 'Subjective reporting on respiratory symptoms', 'Fractional concentration of nitric oxide in exhaled breath ( F E NO ) and peak expiratory flow (PEF', 'higher comfortability', 'breathability']",[],"[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0181758', 'cui_str': 'Surgical face mask'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0024861', 'cui_str': 'Mask'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0225387', 'cui_str': 'Exhaled air'}, {'cui': 'C1298908', 'cui_str': 'No'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0138609,"Results


Subjects assigned the LMC mask had a lowered  F E NO  ( p <0.05) compared to conventional face masks after mask wearing.","[{'ForeName': 'Sy', 'Initials': 'S', 'LastName': 'Duong-Quy', 'Affiliation': 'Medical-Biological Research Center, Lamdong Medical College, Da Lat city, Vietnam.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Ngo-Minh', 'Affiliation': 'Pham Ngoc Thach Medical University, Ho Chi Minh city, Vietnam Co-first author.'}, {'ForeName': 'Trinh', 'Initials': 'T', 'LastName': 'Tang-Le-Quynh', 'Affiliation': 'Medical-Biological Research Center, Lamdong Medical College, Da Lat city, Vietnam.'}, {'ForeName': 'Tram', 'Initials': 'T', 'LastName': 'Tang-Thi-Thao', 'Affiliation': 'Medical-Biological Research Center, Lamdong Medical College, Da Lat city, Vietnam.'}, {'ForeName': 'Bao', 'Initials': 'B', 'LastName': 'Nguyen-Quoc', 'Affiliation': 'Medical-Biological Research Center, Lamdong Medical College, Da Lat city, Vietnam.'}, {'ForeName': 'Khiet', 'Initials': 'K', 'LastName': 'Le-Quang', 'Affiliation': 'Medical-Biological Research Center, Lamdong Medical College, Da Lat city, Vietnam.'}, {'ForeName': 'Dinh', 'Initials': 'D', 'LastName': 'Tran-Thanh', 'Affiliation': 'Medical-Biological Research Center, Lamdong Medical College, Da Lat city, Vietnam.'}, {'ForeName': 'Nhu', 'Initials': 'N', 'LastName': 'Doan-Thi-Quynh', 'Affiliation': 'Medical-Biological Research Center, Lamdong Medical College, Da Lat city, Vietnam.'}, {'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Canty', 'Affiliation': 'Division of Immuno-Allergology, Hershey Medical Center, Penn State Medical College, Hershey, PA, USA.'}, {'ForeName': 'Toan', 'Initials': 'T', 'LastName': 'Do', 'Affiliation': 'Division of Immuno-Allergology, Hershey Medical Center, Penn State Medical College, Hershey, PA, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Craig', 'Affiliation': 'Division of Immuno-Allergology, Hershey Medical Center, Penn State Medical College, Hershey, PA, USA.'}]",Multidisciplinary respiratory medicine,['10.4081/mrm.2020.664']
2673,32549994,The IBER study: study protocol for a feasibility randomised controlled trial of Imagery Based Emotion Regulation for the treatment of anxiety in bipolar disorder.,"Background


Anxiety is highly prevalent in people diagnosed with bipolar disorder (BD), and can persist between acute episodes of mania and depression. Recent studies indicate that people with BD are prone to experiencing frequent, intrusive and emotional mental images which further fuel their levels of anxiety and mood instability. These intrusive emotional mental images represent a specific target for treatment for this disorder with the potential to reduce anxiety and improve mood stability. A new brief structured psychological intervention for BD called Imagery Based Emotion Regulation (IBER) has been developed, which translates experimental work in the area of imagery and emotion into a skills training programme to improve the regulation of intrusive and distressing emotional mental images in BD. A feasibility trial is required in order to assess whether a full randomised controlled trial is indicated in order to evaluate this approach.
Methods


The design is a two-arm feasibility randomised controlled trial (RCT), with 1:1 randomisation stratified by trial site and minimised on medication status and anxiety severity. Participants are 60 individuals diagnosed with bipolar disorder and experiencing at least a mild level of anxiety. Sites are defined by the geographical boundaries of two National Health Service (NHS) Trusts, with recruitment from NHS teams, GP surgeries and self-referral. The intervention is up to 12 sessions of Imagery Based Emotion Regulation within 16 weeks. The comparator is NHS standard care. The primary aim is to assess the feasibility of conducting a powered multi-site RCT to evaluate effectiveness. Measures of anxiety, depression, mania, mood stability and health care use will be conducted at baseline, end of treatment and at 16-week follow-up.
Discussion


This is the first feasibility trial of an imagery-based intervention for the treatment of anxiety in bipolar disorder. If the trial proves feasible, a large multi-site trial will be required.
Trial registration


ISRCTN16321795. Registered on October 16, 2018. 10.1186/ISRCTN16321795.",2020,"A new brief structured psychological intervention for BD called Imagery Based Emotion Regulation (IBER) has been developed, which translates experimental work in the area of imagery and emotion into a skills training programme to improve the regulation of intrusive and distressing emotional mental images in BD.","['anxiety in bipolar disorder', 'Participants are 60 individuals diagnosed with bipolar disorder and experiencing at least a mild level of anxiety', 'people diagnosed with bipolar disorder (BD']","['psychological intervention for BD called Imagery Based Emotion Regulation (IBER', 'imagery-based intervention', 'Imagery Based Emotion Regulation']","['anxiety, depression, mania, mood stability and health care']","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0338831', 'cui_str': 'Mania'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]",,0.140453,"A new brief structured psychological intervention for BD called Imagery Based Emotion Regulation (IBER) has been developed, which translates experimental work in the area of imagery and emotion into a skills training programme to improve the regulation of intrusive and distressing emotional mental images in BD.","[{'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Steel', 'Affiliation': 'Oxford Health NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Wright', 'Affiliation': 'University of Exeter, Exeter, UK.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Goodwin', 'Affiliation': 'University of Oxford, Oxford, UK.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Simon', 'Affiliation': 'Oxford Health NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Morant', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Rod', 'Initials': 'R', 'LastName': 'Taylor', 'Affiliation': 'University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': 'University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Susie', 'Initials': 'S', 'LastName': 'Jennings', 'Affiliation': 'University of Reading, Reading, UK.'}, {'ForeName': 'Susie', 'Initials': 'S', 'LastName': 'Hales', 'Affiliation': 'Oxford Health NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Holmes', 'Affiliation': 'Karolinska Institut, Stockholm, Sweden.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00628-8']
2674,32552001,Practical Approach to Using Trend Arrows on Real-Time Continuous Glucose Monitoring System in Type 1 Diabetes Adolescents Living Camp Setting Treated With Multiple Daily Injection or Continuous Subcutaneous Insulin Infusion Insulin Therapy.,"BACKGROUND


The aim of the study was to determine the effect of an educational intervention on the use of trend arrows of a real-time continuous glucose monitoring (rt-CGM) to manage daily therapy decisions in a group of adolescents with type 1 diabetes attending a camp. The secondary aim was to evaluate the variations in total daily dose (TDD) of insulin requirement.
METHODS


Twenty patients (15-17 years) on multiple insulin injections ( n  = 8) or continuous subcutaneous insulin infusion ( n  = 12) attended a training session at the beginning of the camp to learn our algorithm for the management of therapy depending on trend arrows. TDD, time in range (TIR), time above range (TAR), and time below range (TBR) (in the 24 hours and in the three hours after breakfast) before the training session (run-in) and at the end of the camp (T1) were analyzed.
RESULTS


Data showed a reduction of TAR (run-in 42.6%, T1 32.05%,  P  = .036) and an increase in TIR (run-in 52.9%, T1 62.4%,  P  = .013). Reduction of TBR (run-in 42.5%, T1 37.5%,  P  = .05) and improvement in TIR (run-in 49.0%, T1 57.0%,  P  = .02) were also observed in the post-breakfast period. Data showed a significant reduction in the TDD (run-in 52.02 ± 17.44 U/die, T1 46.49 ± 12.39 U/die,  P  = .024).
CONCLUSIONS


Statistically significant improvement of glycemic control and reduction of TTD were observed in all patients regardless of therapy type. The improvement between run-in and T1 demonstrates the importance of patients' education on the correct use of rt-CGM with simple algorithms for the management of therapy.",2020,"Reduction of TBR (run-in 42.5%, T1 37.5%,  P  = .05) and improvement in TIR (run-in 49.0%, T1 57.0%,  P  = .02) were also observed in the post-breakfast period.","['Adolescents Living Camp Setting', 'Type 1 Diabetes', 'adolescents with type 1 diabetes attending a camp', 'Twenty patients (15-17\u2009years) on']","['multiple insulin injections ( n  = 8) or continuous subcutaneous insulin infusion ( n  = 12) attended a training session at the beginning of the camp to learn our algorithm for the management of therapy depending on trend arrows', 'real-time continuous glucose monitoring (rt-CGM', 'educational intervention']","['Reduction of TBR', 'total daily dose (TDD) of insulin requirement', 'TDD, time in range (TIR), time above range (TAR), and time below range (TBR', 'reduction of TAR', 'TDD', 'glycemic control and reduction of TTD', 'TIR']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0336721', 'cui_str': 'Arrow'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0039315', 'cui_str': 'Tar'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012772', 'cui_str': 'Disulfiram'}, {'cui': 'C0574173', 'cui_str': 'Tigrinya language'}]",,0.0177503,"Reduction of TBR (run-in 42.5%, T1 37.5%,  P  = .05) and improvement in TIR (run-in 49.0%, T1 57.0%,  P  = .02) were also observed in the post-breakfast period.","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Bassi', 'Affiliation': 'Clinica pediatrica, IRCCS G.Gaslini, Genova, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Minuto', 'Affiliation': 'Clinica pediatrica, IRCCS G.Gaslini, Genova, Italy.'}, {'ForeName': 'Graziella', 'Initials': 'G', 'LastName': 'Fichera', 'Affiliation': 'UOC Pediatria e Neonatologia, Ospedale S.Paolo, Savona, Italy.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Rebora', 'Affiliation': 'Clinica pediatrica, IRCCS G.Gaslini, Genova, Italy.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Parodi', 'Affiliation': 'Clinica pediatrica, IRCCS G.Gaslini, Genova, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Natoli', 'Affiliation': 'Clinica pediatrica, IRCCS G.Gaslini, Genova, Italy.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Pontillo', 'Affiliation': 'Servizio di Dietologia, IRCCS G.Gaslini, Genova, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Buccianti', 'Affiliation': 'Dietitian Consultant, Grosseto, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': ""d'Annunzio"", 'Affiliation': 'Clinica pediatrica, IRCCS G.Gaslini, Genova, Italy.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Maghnie', 'Affiliation': 'Clinica pediatrica, IRCCS G.Gaslini, Genova, Italy.'}]",Journal of diabetes science and technology,['10.1177/1932296820934803']
2675,32552074,Randomized controlled feasibility study of FindMyApps: first evaluation of a tablet-based intervention to promote self-management and meaningful activities in people with mild dementia.,"Objectives:  We tested the feasibility, implementation strategy and mechanism of impact of FindMyApps. FindMyApps is a tablet intervention consisting of a selection tool to help people with dementia find usable apps for self-management and meaningful activities, including training to support informal carers in employing errorless learning principles to help people with dementia learn tablet and tool usage. Methods:  We conducted an exploratory, pilot randomized controlled trial with a mixed-methods design. Twenty persons with mild dementia and carer dyads were randomly assigned to the FindMyApps group ( n  = 10), receiving either the FindMyApps training and selection tool, or a control condition ( n  = 10), receiving only a short tablet training. Pre- and post-test measurements at a three month follow-up, consisted of questionnaires and post-test semi-structured interviews. Results:  The FindMyApps tool was mostly perceived as useful and easy to use. Persons with dementia were generally able to learn how to use the tool, though they regularly needed support from informal carers. Persons with dementia found apps through the tool, which they used regularly. Persons with dementia and informal carers were positive about the training and support they received. No significant differences were found on outcome measures of persons with dementia, but based on effect sizes FindMyApps is a promising intervention. Conclusions:  Qualitative results indicate that the FindMyApps intervention has the potential to positively influence the self-management abilities and engagement in meaningful activities of people with dementia. Remarks are made to improve the intervention and recommendations are given for future effectiveness studies.Implications for rehabilitationThe person-centred tablet intervention FindMyApps has the potential to positively influence the self-management and engagement in meaningful activities in people with dementia.Based on the input of persons with dementia and informal carers, the FindMyApps intervention and study procedure will be further improved and evaluated in terms of effectiveness in an RCT.",2020,"Persons with dementia were generally able to learn how to use the tool, though they regularly needed support from informal carers.","['persons with dementia and informal carers', 'Persons with dementia', 'Twenty persons with mild dementia and carer dyads', 'people with mild dementia', 'Persons with dementia found apps through the tool, which they used regularly', 'people with dementia', 'Persons with dementia and informal carers']","['FindMyApps group ( n \u2009=\u200910), receiving either the FindMyApps training and selection tool, or a control condition ( n \u2009=\u200910), receiving only a short tablet training', 'tablet-based intervention']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C3494623', 'cui_str': 'Mild dementia'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],20.0,0.0315857,"Persons with dementia were generally able to learn how to use the tool, though they regularly needed support from informal carers.","[{'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Kerkhof', 'Affiliation': 'Centre for Nursing Research, Sector Health Care, Saxion University of Applied Sciences, Deventer, The Netherlands.'}, {'ForeName': 'Gianna', 'Initials': 'G', 'LastName': 'Kohl', 'Affiliation': 'Faculty of Behavioural, Management and Social Sciences, University of Twente, Enschede, The Netherlands.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Veijer', 'Affiliation': 'Faculty of Behavioural, Management and Social Sciences, University of Twente, Enschede, The Netherlands.'}, {'ForeName': 'Floriana', 'Initials': 'F', 'LastName': 'Mangiaracina', 'Affiliation': 'Department of Psychiatry, Amsterdam Public Health Institute, Amsterdam University Medical Centres, Location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Ad', 'Initials': 'A', 'LastName': 'Bergsma', 'Affiliation': 'Centre for Nursing Research, Sector Health Care, Saxion University of Applied Sciences, Deventer, The Netherlands.'}, {'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Graff', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Scientific Institute for Quality of Healthcare, Radboud Alzheimer Centre, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Rose-Marie', 'Initials': 'RM', 'LastName': 'Dröes', 'Affiliation': 'Department of Psychiatry, Amsterdam Public Health Institute, Amsterdam University Medical Centres, Location VUmc, Amsterdam, The Netherlands.'}]",Disability and rehabilitation. Assistive technology,['10.1080/17483107.2020.1765420']
2676,32552138,Community Targeting of Uncontrolled Hypertension: Results of a Hypertension Screening and Education Intervention in Community Churches Serving Predominantly Racial/Ethnic Minority Populations.,"Background.  Uncontrolled hypertension is the primary risk factor for the development of cardiovascular complications and particularly burdens racial/ethnic minority populations.  Aim.  To determine the effectiveness of a community hypertension screening, education, and empowerment intervention on blood pressure (BP) improvement.  Method . We screened 152 participants across four churches in predominantly racial/ethnic minority neighborhoods for elevated BP. During this visit, those with BP ≥ 140/90 mmHg were enrolled in the study and completed interventions. Individuals with moderately elevated BP (≥140/90 and <160/100 mmHg; Group 1) viewed a 3-minute hypertension education video. Individuals with severely elevated BP (≥160/100 mmHg; Group 2) additionally viewed echocardiograms images with subclinical changes from uncontrolled hypertension and had a brief on-site medication review with a pharmacist. Both groups received automated BP monitors and information on neighborhood federally qualified health centers for primary care. Participants returned to each church for follow-up 3 months later. We analyzed BP difference at 3 months and percentage with controlled BP for each group.  Results . For Group 1, mean baseline and follow-up BPs were 143.5/88.0 mmHg and 138.5/85.8 mmHg, respectively. For Group 2, BPs significantly decreased from 165.4/98.3 mmHg to 150.4/90.8 mmHg. After the intervention, participants with controlled BP for Groups 1 and 2 were 35.5% and 55.2%, respectively.  Discussion . Participants in both groups had BP improvements. Greater improvements were in individuals at higher cardiovascular risk due to severely elevated BPs (≥160/100 mmHg).  Conclusion . This pilot highlights the impact that streamlined empowerment interventions with dedicated health personnel can have in high-risk communities with elevated BPs.",2020,Individuals with severely elevated BP (≥160/100 mmHg; Group 2) additionally viewed echocardiograms images with subclinical changes from uncontrolled hypertension and had a brief on-site medication review with a pharmacist.,"['140/90 mmHg were enrolled in the study and completed interventions', '152 participants across four churches in predominantly racial/ethnic minority neighborhoods for elevated BP', 'Individuals with severely elevated BP (≥160/100 mmHg; Group 2) additionally viewed echocardiograms images with subclinical changes from uncontrolled hypertension and had a brief on-site medication review with a pharmacist', 'Individuals with moderately elevated BP (≥140/90 and <160/100 mmHg; Group 1) viewed a 3-minute hypertension education video', 'Uncontrolled Hypertension']","['community hypertension screening, education, and empowerment intervention', 'Hypertension Screening and Education Intervention']","['blood pressure (BP) improvement', 'BP improvements']","[{'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0562324', 'cui_str': 'Church'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0497247', 'cui_str': 'Elevated blood pressure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0560023', 'cui_str': 'Review of medication'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0204946', 'cui_str': 'Hypertension education'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0740221', 'cui_str': 'Hypertension screening'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",152.0,0.0420355,Individuals with severely elevated BP (≥160/100 mmHg; Group 2) additionally viewed echocardiograms images with subclinical changes from uncontrolled hypertension and had a brief on-site medication review with a pharmacist.,"[{'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Prendergast', 'Affiliation': 'University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Escobar-Schulz', 'Affiliation': 'University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Del Rios', 'Affiliation': 'University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Petzel-Gimbar', 'Affiliation': 'University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'McPherson', 'Affiliation': 'University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Jackson', 'Affiliation': 'University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'KaLynn', 'Initials': 'K', 'LastName': 'Terrell', 'Affiliation': 'Marian University, Indianapolis, IN, USA.'}, {'ForeName': 'Sara W', 'Initials': 'SW', 'LastName': 'Heinert', 'Affiliation': 'University of Illinois at Chicago, Chicago, IL, USA.'}]",Health promotion practice,['10.1177/1524839920933897']
2677,32552153,"Safety and tolerability of empagliflozin and linagliptin combination therapy in patients with type 2 diabetes mellitus: a pooled analysis of data from five randomized, controlled clinical trials.","OBJECTIVES


The fixed-dose combination of empagliflozin and linagliptin, two glucose-lowering drugs prescribed for type 2 diabetes mellitus, has demonstrated good tolerability in phase III clinical trials. To further evaluate the safety profile of this combination, the data from these trials was pooled and analyzed.
METHODS


This was a post-hoc pooled analysis of five randomized, double-blind, clinical trials of the empagliflozin/linagliptin fixed-dose combination. Data for adverse events and laboratory parameters was evaluated.
RESULTS


The analysis included 2895 patients: 1410, 1015, and 470 receiving the empagliflozin/linagliptin combination, empagliflozin monotherapy, and linagliptin monotherapy, respectively. Overall, the incidence of adverse events with the empagliflozin/linagliptin combination was similar to that with empagliflozin or linagliptin alone. Fewer than 2% of patients experienced hypoglycemia, and its incidence was similar across treatment groups. Genital infections occurred in more patients receiving empagliflozin/linagliptin (3.0%) or empagliflozin monotherapy (5.1%) than in those receiving linagliptin monotherapy (1.9%). No cases of Fournier's gangrene, diabetic ketoacidosis, or pemphigoid occurred, and no clinically relevant mean changes in laboratory parameters were noted.
CONCLUSION


The safety profile of the fixed-dose combination of empagliflozin and linagliptin was similar to the individual monotherapies. No new safety signals were identified.
TRIAL REGISTRATION


The trials included in this pooled analysis are registered at ClinicalTrials.gov (CT.gov identifiers: NCT01422876, NCT01734785, NCT01778049, NCT02453555, NCT02489968).",2020,Genital infections occurred in more patients receiving empagliflozin/linagliptin (3.0%) or empagliflozin monotherapy (5.1%) than in those receiving linagliptin monotherapy (1.9%).,"['patients with type 2 diabetes mellitus', 'type 2 diabetes mellitus', '2895 patients: 1410, 1015, and 470 receiving the']","['empagliflozin monotherapy', 'empagliflozin/linagliptin combination, empagliflozin monotherapy, and linagliptin monotherapy', 'empagliflozin', 'empagliflozin and linagliptin', 'empagliflozin and linagliptin, two glucose-lowering drugs', 'empagliflozin/linagliptin', 'linagliptin monotherapy', 'empagliflozin and linagliptin combination therapy', 'empagliflozin/linagliptin fixed-dose combination', 'linagliptin']","['Safety and tolerability', 'hypoglycemia', ""Fournier's gangrene, diabetic ketoacidosis, or pemphigoid"", 'Genital infections', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C3871442', 'cui_str': 'linagliptin and empagliflozin'}, {'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0017086', 'cui_str': 'Gangrene'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0030805', 'cui_str': 'Bullous pemphigoid'}, {'cui': 'C0729552', 'cui_str': 'Genital infection'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",2895.0,0.279202,Genital infections occurred in more patients receiving empagliflozin/linagliptin (3.0%) or empagliflozin monotherapy (5.1%) than in those receiving linagliptin monotherapy (1.9%).,"[{'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Watada', 'Affiliation': 'Department of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine , Tokyo, Japan.'}, {'ForeName': 'Toshimasa', 'Initials': 'T', 'LastName': 'Yamauchi', 'Affiliation': 'Department of Diabetes and Metabolic Disease, Graduate School of Medicine, Tokyo University , Tokyo, Japan.'}, {'ForeName': 'Fumiko', 'Initials': 'F', 'LastName': 'Yamamoto', 'Affiliation': 'Medicine Division, Nippon Boehringer Ingelheim Co. Ltd , Tokyo, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Taniguchi', 'Affiliation': 'Biostatistics & Data Science, Nippon Boehringer Ingelheim Co. Ltd , Tokyo, Japan.'}, {'ForeName': 'Larisa', 'Initials': 'L', 'LastName': 'Yarush', 'Affiliation': 'Global Pharmacovigilance, Boehringer Ingelheim Pharmaceuticals, Inc ., Ridgefield, CT, USA.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Heilmann', 'Affiliation': 'Global Medical Affairs, Boehringer Ingelheim International GmbH , Ingelheim, Germany.'}, {'ForeName': 'Atsutaka', 'Initials': 'A', 'LastName': 'Yasui', 'Affiliation': 'Medicine Division, Nippon Boehringer Ingelheim Co. Ltd , Tokyo, Japan.'}]",Expert opinion on drug safety,['10.1080/14740338.2020.1782884']
2678,32552207,"Re: Long-Term Oncological Outcomes from an Early Phase Randomised Controlled Three-Arm Trial of Open, Robotic, and Laparoscopic Radical Cystectomy (CORAL).",,2020,,[],"['Open, Robotic, and Laparoscopic Radical Cystectomy (CORAL']",[],[],"[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C0324034', 'cui_str': 'Coral'}]",[],,0.0947995,,"[{'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Cadeddu', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001166']
2679,32552430,Differential changes in muscle architecture and neuromuscular fatigability induced by isometric resistance training at short and long muscle-tendon unit lengths.,"We evaluated the effects of differential muscle architectural adaptations on neuromuscular fatigue resistance. Seven young males and 6 females participated in this study. Using a longitudinal within-subject design, legs were randomly assigned to perform isometric training of the tibialis anterior (TA) 3× per week for 8 weeks at a short (S-Group) or long muscle-tendon unit length (L-Group). Before and following training, fascicle length (FL) and pennation angle (PA) of the TA were assessed. As well, fatigue-related time-course changes in isometric maximal voluntary contraction (MVC) torque and isotonic peak power (20%MVC resistance) were determined before, immediately, 1, 2, 5, and 10 min following task failure. The fatiguing task consisted of repeated maximal effort isotonic (20%MVC resistance) contractions over a 40° range of motion, until the participant reached a 40% reduction in peak power. Although there was no clear improvement of neuromuscular fatigue resistance following training in both groups (P = 0.081; S-Group: ~20%, L-Group: ~51%), the change in neuromuscular fatigue resistance was related positively to the training-induced increase in PA (~6%, P < 0.001) in the S-Group (r = 0.739, P = 0.004) and negatively to the training-induced increase in FL (~4%, P = 0.001) in the L-Group (r = -0.568, P = 0.043). Both groups recovered similarly for MVC torque and peak power after the fatiguing task as compared to before training. We suggest that the relationships between the changes in muscle architecture and neuromuscular fatigue resistance depend on the muscle-tendon unit lengths at which the training is performed.",2020,"Although there was no clear improvement of neuromuscular fatigue resistance following training in both groups (P = 0.081; S-Group: ~20%, L-Group: ~51%), the change in neuromuscular fatigue resistance was related positively to the training-induced increase in PA (~6%, P < 0.001) in the S-Group (r = 0.739, P = 0.004) and negatively to the training-induced increase in FL (~4%, P = 0.001) in the L-Group (r = -0.568, P = 0.043).",['Seven young males and 6 females participated in this study'],"['differential muscle architectural adaptations', 'isometric resistance training', 'isometric training of the tibialis anterior (TA', 'fatiguing task consisted of repeated maximal effort isotonic (20%MVC resistance) contractions']","['FL', 'PA', 'fascicle length (FL) and pennation angle (PA) of the TA', 'neuromuscular fatigue resistance', 'fatigue-related time-course changes in isometric maximal voluntary contraction (MVC) torque and isotonic peak power (20%MVC resistance', 'MVC torque and peak power']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0242690', 'cui_str': 'Tibialis anterior muscle structure'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0242690', 'cui_str': 'Tibialis anterior muscle structure'}, {'cui': 'C0234116', 'cui_str': 'Neuromuscular fatigue'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0449247', 'cui_str': 'Time course'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0444505', 'cui_str': 'Peak'}]",7.0,0.0211373,"Although there was no clear improvement of neuromuscular fatigue resistance following training in both groups (P = 0.081; S-Group: ~20%, L-Group: ~51%), the change in neuromuscular fatigue resistance was related positively to the training-induced increase in PA (~6%, P < 0.001) in the S-Group (r = 0.739, P = 0.004) and negatively to the training-induced increase in FL (~4%, P = 0.001) in the L-Group (r = -0.568, P = 0.043).","[{'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Akagi', 'Affiliation': 'College of Systems Engineering and Science, Shibaura Institute of Technology, Japan.'}, {'ForeName': 'Avery', 'Initials': 'A', 'LastName': 'Hinks', 'Affiliation': 'Human Health and Nutritional Sciences, University of Guelph, Canada.'}, {'ForeName': 'Geoffrey Alonzo', 'Initials': 'GA', 'LastName': 'Power', 'Affiliation': 'Human Health and Nutritional Sciences, University of Guelph, Canada.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00280.2020']
2680,32552433,"Inspiratory flow resistive breathing, respiratory muscle induced systemic oxidative stress and diaphragm fatigue in healthy humans.","We questioned whether the respiratory muscles of humans contribute to systemic oxidative stress following inspiratory flow resistive breathing, if the amount of oxidative stress is influenced by the level of resistive load, and whether the amount of oxidative stress is related to the degree of diaphragm fatigue incurred. Eight young and healthy participants attended the laboratory for 4 visits on separate days. During the first visit, height, body mass, lung function and maximal inspiratory mouth and transdiaphragmatic pressure (P dimax ) were assessed. During visits 2-4, participants undertook inspiratory flow resistive breathing with either no resistance (Control) or resistive loads equivalent to 50 and 70% of their P dimax  (P dimax 50% and P dimax 70%) for 30 min. Participants undertook 1 resistive load per visit, and the order that they undertook the loads was randomized. Inspiratory muscle pressures were higher (P < 0.05) during the 5th and final min of P dimax 50% and P dimax 70% compared to Control. Plasma F 2 -isoprostanes increased (P < 0.05) following inspiratory flow resistive breathing at P dimax 70%. There were no increases in plasma protein carbonyls and total antioxidant capacity. Further, although we evidenced small reductions in transdiapragmaic twitch pressures (P diTW ) after inspiratory flow resistive breathing at P dimax 50% and P dimax 70%, this was not related to the increase in plasma F 2 -isoprostanes. Our novel data suggest that only when sufficiently strenuous, inspiratory flow resistive breathing in humans elicits systemic oxidative stress evidenced by elevated plasma F 2 -isoprostanes, and based on our data this is not related to a reduction in P diTW .",2020,Plasma F 2 -isoprostanes increased (P < 0.05) following inspiratory flow resistive breathing at P dimax 70%.,"['Eight young and healthy participants attended the laboratory for 4 visits on separate days', 'healthy humans']","['Inspiratory flow resistive breathing, respiratory muscle', 'inspiratory flow resistive breathing']","['Plasma F 2 -isoprostanes', 'Inspiratory muscle pressures', 'plasma F 2 -isoprostanes', 'inspiratory flow resistive breathing with either no resistance (Control) or resistive loads equivalent', 'transdiapragmaic twitch pressures', 'plasma protein carbonyls and total antioxidant capacity', 'height, body mass, lung function and maximal inspiratory mouth and transdiaphragmatic pressure (P dimax ']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0949860', 'cui_str': 'Isoprostane'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}, {'cui': 'C0032120', 'cui_str': 'Plasma protein'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205504', 'cui_str': 'Transdiaphragmatic approach'}]",8.0,0.0373658,Plasma F 2 -isoprostanes increased (P < 0.05) following inspiratory flow resistive breathing at P dimax 70%.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Briskey', 'Affiliation': 'University of Queensland.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Vogel', 'Affiliation': 'University of Southern Queensland, Australia.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Johnson', 'Affiliation': 'Sport Science, Nottingham Trent University, United Kingdom.'}, {'ForeName': 'Graham R', 'Initials': 'GR', 'LastName': 'Sharpe', 'Affiliation': 'Sport, Health and Performance Enhancement (SHAPE) Research Group, Nottingham Trent University, United Kingdom.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Coombes', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland.'}, {'ForeName': 'Dean E', 'Initials': 'DE', 'LastName': 'Mills', 'Affiliation': 'School of Health and Wellbeing, University of Southern Queensland, Australia.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00091.2020']
2681,32552446,Online couples mindfulness-based intervention for young breast cancer survivors and their partners: A randomized-control trial.,"Purpose:  Young breast cancer survivors (YBCS) face unique challenges in coping with disease, distress, and relationship concerns. The purposes of this study were to understand the acceptability and feasibility of an online Mindfulness-Based Intervention (MBI) for YBCS and their partners (i.e., Couples Mindfulness-Based Intervention: C-MBI) and to compare the effectiveness of the C-MBI to a closely-matched control, an online MBI for individuals (I-MBI). Methods:  YBCS and their partners were recruited. Couples were randomly assigned to an 8-week C-MBI (couples = 41) or to I-MBI (couples = 36), which included one-hour video modules, a manual, and guided-meditation audios. Both couple members participated in the C-MBI; only the YBCS participated in the control I-MBI. Participants answered surveys about individual- and couple-level functioning at baseline and post-intervention. Results:  Online delivery was shown to be feasible and acceptable. For YBCS and their partners, levels of perceived stress, anxiety, depression, and fatigue were lower after the intervention, in both conditions. Unexpectedly, however, participating in the C-MBI appeared to have detrimental effects on dyadic adjustment and relationship quality. Conclusion:  Although YBCS and their partners reported online delivery was acceptable and benefited well-being, for couple-based MBIs to have benefits for relationship functioning, it may be necessary for couples to have the support of other couples and an instructor. Online delivery may be particularly acceptable and effective for clinical populations, including YBCS. Medical professionals may be more likely to recommend online-MBI programs to cancer survivors, because the programs are of little or no cost.",2020,"For YBCS and their partners, levels of perceived stress, anxiety, depression, and fatigue were lower after the intervention, in both conditions.","['individuals (I-MBI', 'young breast cancer survivors and their partners', 'Young breast cancer survivors (YBCS']","['online Mindfulness-Based Intervention (MBI', 'Online couples mindfulness-based intervention', 'YBCS']","['levels of perceived stress, anxiety, depression, and fatigue']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2985547', 'cui_str': 'Scintimammography'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2985547', 'cui_str': 'Scintimammography'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.0334225,"For YBCS and their partners, levels of perceived stress, anxiety, depression, and fatigue were lower after the intervention, in both conditions.","[{'ForeName': 'Mollie A', 'Initials': 'MA', 'LastName': 'Price-Blackshear', 'Affiliation': 'Department of Psychological Sciences, University of Missouri, Columbia, Missouri, USA.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Pratscher', 'Affiliation': 'Department of Psychological Sciences, University of Missouri, Columbia, Missouri, USA.'}, {'ForeName': 'Danielle L', 'Initials': 'DL', 'LastName': 'Oyler', 'Affiliation': 'Department of Psychological Sciences, University of Missouri, Columbia, Missouri, USA.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Armer', 'Affiliation': 'Sinclair School of Nursing, University of Missouri, Columbia, Missouri, USA.'}, {'ForeName': 'An-Lin', 'Initials': 'AL', 'LastName': 'Cheng', 'Affiliation': 'Department of Biomedical and Health Informatics, School of Medicine, University of Missouri-Kansas, Kansas City, Missouri, USA.'}, {'ForeName': 'Maggie X', 'Initials': 'MX', 'LastName': 'Cheng', 'Affiliation': 'Department of Applied Mathematics, Illinois Institute of Technology, Chicago, Illinois, USA.'}, {'ForeName': 'Kathie', 'Initials': 'K', 'LastName': 'Records', 'Affiliation': 'University of Missouri-St. Louis, College of Nursing, St. Louis, Missouri, USA.'}, {'ForeName': 'Tipparat', 'Initials': 'T', 'LastName': 'Udmuangpia', 'Affiliation': 'Sinclair School of Nursing, University of Missouri, Columbia, Missouri, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Carson', 'Affiliation': 'Departments of Anesthesiology & Perioperative Medicine, and Psychiatry, Oregon Health and Science University, Portland, Oregon, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Ann Bettencourt', 'Affiliation': 'Department of Psychological Sciences, University of Missouri, Columbia, Missouri, USA.'}]",Journal of psychosocial oncology,['10.1080/07347332.2020.1778150']
2682,32552472,Successful Outcomes of Newly Diagnosed T Lymphoblastic Lymphoma: Results From Children's Oncology Group AALL0434.,"PURPOSE


The Children's Oncology Group (COG) protocol AALL0434 evaluated the safety and efficacy of multi-agent chemotherapy with Capizzi-based methotrexate/pegaspargase (C-MTX) in patients with newly diagnosed pediatric T-cell lymphoblastic lymphoma (T-LL) and gained preliminary data using nelarabine in high-risk patients.
PATIENTS AND METHODS


The trial enrolled 299 patients, age 1-31 years. High-risk (HR) patients had ≥ 1% minimal detectable disease (MDD) in the bone marrow at diagnosis or received prior steroid treatment. Induction failure was defined as failure to achieve a partial response (PR) by the end of the 4-week induction. All patients received the augmented Berlin-Frankfurt-Muenster (ABFM) C-MTX regimen. HR patients were randomly assigned to receive or not receive 6 5-day courses of nelarabine incorporated into ABFM. Patients with induction failure were nonrandomly assigned to ABFM C-MTX plus nelarabine. No patients received prophylactic cranial radiation; however, patients with CNS3 disease (CSF WBC ≥ 5/μL with blasts or cranial nerve palsies, brain/eye involvement, or hypothalamic syndrome) were ineligible.
RESULTS


At end-induction, 98.8% of evaluable participants had at least a PR. The 4-year event-free survival (EFS) and overall survival (OS) were 84.7% ± 2.3% and 89.0% ± 2.0%. The 4-year disease-free survival (DFS) from end-induction was 85.9% ± 2.6%. There was no difference in DFS observed between the HR and standard-risk groups ( P  = .29) or by treatment regimen ( P  = .55). Disease stage, tumor response, and MDD at diagnosis did not demonstrate thresholds that resulted in differences in EFS. Nelarabine did not show an advantage for HR patients. CNS relapse occurred in only 4 patients.
CONCLUSION


COG AALL0434 produced excellent outcomes in one of the largest trials ever conducted for patients with newly diagnosed T-LL. The COG ABFM regimen with C-MTX provided excellent EFS and OS without cranial radiation.",2020,There was no difference in DFS observed between the HR and standard-risk groups ( P  = .29) or by treatment regimen ( P  = .55).,"['patients with newly diagnosed pediatric T-cell lymphoblastic lymphoma (T-LL) and gained preliminary data using nelarabine in high-risk patients', '299 patients, age 1-31 years', 'patients with CNS3 disease (CSF WBC', 'Patients with induction failure', 'HR patients', 'patients with newly diagnosed T-LL', 'Newly Diagnosed T Lymphoblastic Lymphoma']","['nelarabine incorporated into ABFM', 'COG AALL0434', 'Nelarabine', 'augmented Berlin-Frankfurt-Muenster (ABFM) C-MTX regimen', 'prophylactic cranial radiation', 'multi-agent chemotherapy with Capizzi-based methotrexate/pegaspargase (C-MTX', 'ABFM C-MTX plus nelarabine']","['4-year disease-free survival (DFS', '4-year event-free survival (EFS) and overall survival (OS', 'DFS', '≥ 5/μL with blasts or cranial nerve palsies, brain/eye involvement, or hypothalamic syndrome', 'partial response (PR', 'Induction failure', 'CNS relapse', 'Disease stage, tumor response, and MDD at diagnosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0079748', 'cui_str': 'Precursor cell lymphoblastic lymphoma'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C0907349', 'cui_str': 'nelarabine'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0855357', 'cui_str': 'CSF white blood cell count'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1292758', 'cui_str': 'Precursor T-cell lymphoblastic lymphoma'}]","[{'cui': 'C0907349', 'cui_str': 'nelarabine'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0071568', 'cui_str': 'pegaspargase'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0337026', 'cui_str': 'Blast'}, {'cui': 'C0151311', 'cui_str': 'Cranial nerve paralysis'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0442850', 'cui_str': 'Eye involvement'}, {'cui': 'C0751230', 'cui_str': 'Hypothalamic syndrome'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0028654', 'cui_str': 'Clinical nurse specialist'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",299.0,0.0654142,There was no difference in DFS observed between the HR and standard-risk groups ( P  = .29) or by treatment regimen ( P  = .55).,"[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Hayashi', 'Affiliation': ""Pediatric Hematology/Oncology, Washington School of Medicine, St Louis Children's Hospital, St Louis, MO.""}, {'ForeName': 'Stuart S', 'Initials': 'SS', 'LastName': 'Winter', 'Affiliation': ""Children's Minnesota Cancer and Blood Disorders Program, Minneapolis, MN.""}, {'ForeName': 'Kimberly P', 'Initials': 'KP', 'LastName': 'Dunsmore', 'Affiliation': 'Virginia Tech Carilion School of Medicine and Carilion Clinic, Roanoke, VA.'}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Devidas', 'Affiliation': ""Department of Global Pediatric Medicine, St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistics, College of Medicine and College of Public Health and Health Professions, University of Florida, Gainesville, FL.'}, {'ForeName': 'Brent L', 'Initials': 'BL', 'LastName': 'Wood', 'Affiliation': ""Laboratory Medicine, Seattle Children's Hospital, Seattle, WA.""}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Hermiston', 'Affiliation': ""Department of Pediatrics, UCSF Benioff Children's Hospital and the Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA.""}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Teachey', 'Affiliation': ""Division of Oncology, Department of Pediatrics, Center for Childhood Cancer Research, Children's Hospital of Philadelphia and Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Sherrie L', 'Initials': 'SL', 'LastName': 'Perkins', 'Affiliation': 'Department of Pathology, University of Utah Health Sciences Center, ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, UT.'}, {'ForeName': 'Rodney R', 'Initials': 'RR', 'LastName': 'Miles', 'Affiliation': 'Department of Pathology, University of Utah Health Sciences Center, ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, UT.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Raetz', 'Affiliation': 'Department of Pediatrics and Laura and Isaac Perlmutter Cancer Center at NYU Langone Health, New York, NY.'}, {'ForeName': 'Mignon L', 'Initials': 'ML', 'LastName': 'Loh', 'Affiliation': ""Department of Pediatrics, UCSF Benioff Children's Hospital and the Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA.""}, {'ForeName': 'Naomi J', 'Initials': 'NJ', 'LastName': 'Winick', 'Affiliation': 'Pediatric Hematology/Oncology, University of Texas Southwestern/Simmons Cancer Center, Dallas, TX.'}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Carroll', 'Affiliation': 'Department of Pediatrics and Laura and Isaac Perlmutter Cancer Center at NYU Langone Health, New York, NY.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Hunger', 'Affiliation': ""Division of Oncology, Department of Pediatrics, Center for Childhood Cancer Research, Children's Hospital of Philadelphia and Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Megan S', 'Initials': 'MS', 'LastName': 'Lim', 'Affiliation': ""Department of Pathology and Laboratory Medicine, Children's Hospital of Philadelphia, and The Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Gross', 'Affiliation': 'National Cancer Institute Center for Global Health, Rockville, MD.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Bollard', 'Affiliation': ""Division of Blood and Marrow Transplantation, Children's National Health System, Washington, DC.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00531']
2683,32552707,Correlation of binocular refractive error and calculation of intraocular Lens power for the second eye.,"BACKGROUND


Reducing refractive error has always been a tricky problem. The aim of this study was to verify the correlation between binocular refractive error (RE) after sequential cataract surgery and explore an individualized calculation method of intraocular lens (IOL) for the second eye.
METHODS


This was a prospective study. One hundred eighty-eight affected eyes in 94 age-related cataract patients who underwent sequential cataract surgery in the Department of Ophthalmology, Tangdu Hospital, China, were recruited. Complete case data were included for a correlation analysis of binocular RE. Data obtained in patients with RE values greater than 0.50 diopters (D) in the first eye were extracted and the patients divided randomly into two groups: Group A and B. In the adjustment group, group A, we modified the IOL power for the second eyes as 50% of the RE of the first eye. In group B, the control group, there was no modification. The mean absolute refractive error (MARE) values of the second eyes were evaluated one month after surgery.
RESULTS


The correlation coefficient of the binocular RE after sequential cataract surgery was 0.760 (P < 0.001). After the IOL power of the second eyes was adjusted, the MARE of the second eyes was 0.57 ± 0.41 D, while the MARE of the first eyes was 1.18 ± 0.85 D, and the difference was statistically significant (P < 0.001).
CONCLUSIONS


Binocular REs were positively correlated after sequential cataract surgery. The RE of the second eye can be reduced by adjusting the IOL power based on 50% of the postoperative RE of the first eye.",2020,The correlation coefficient of the binocular RE after sequential cataract surgery was 0.760 (P < 0.001).,"['One hundred eighty-eight affected eyes in 94 age-related cataract patients who underwent sequential cataract surgery in the Department of Ophthalmology, Tangdu Hospital, China, were recruited', 'patients with RE values greater than 0.50 diopters (D) in the first eye']",['sequential cataract surgery and explore an individualized calculation method of intraocular lens (IOL'],"['binocular refractive error (RE', 'IOL power', 'mean absolute refractive error (MARE) values', 'binocular RE']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0034951', 'cui_str': 'Disorder of refraction'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439484', 'cui_str': 'Diopters'}]","[{'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C1441506', 'cui_str': 'Calculation technique'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}]","[{'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0034951', 'cui_str': 'Disorder of refraction'}, {'cui': 'C0429521', 'cui_str': 'Intraocular lens power'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",188.0,0.0263921,The correlation coefficient of the binocular RE after sequential cataract surgery was 0.760 (P < 0.001).,"[{'ForeName': 'Pengcheng', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': ""Xi'an Fourth Hospital, Shaanxi Eye Hospital, Affiliated Xi'an Fourth Hospital, Northwestern Polytechnical University, Xi'an, 710004, Shaanxi Province, China.""}, {'ForeName': 'Yuhuan', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Ophthalmology, Tangdu Hospital, Fourth Military Medical University, Xi'an, 710038, Shaanxi Province, China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': ""Xi'an Fourth Hospital, Shaanxi Eye Hospital, Affiliated Xi'an Fourth Hospital, Northwestern Polytechnical University, Xi'an, 710004, Shaanxi Province, China. yan2128ts@hotmail.com.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Ophthalmology, Tangdu Hospital, Fourth Military Medical University, Xi'an, 710038, Shaanxi Province, China.""}, {'ForeName': 'Weijia', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': 'Department of Ophthalmology, University of Heidelberg, 69120, Heidelberg, Germany.'}]",BMC ophthalmology,['10.1186/s12886-020-01496-9']
2684,32552711,Effect of symmetrical restoration for the migration of uncemented total hip arthroplasty: a randomized RSA study with 75 patients and 5-year follow-up.,"BACKGROUND


Inferior placement of a femoral stem is predictive for early loosening and failure, but does restoration of the original hip anatomy benefit the function and survival of a total hip replacement?
METHODS


Seventy-five patients with primary unilateral hip osteoarthritis operated with an uncemented anatomical stem were randomized for either standard or modular stems. We used 50 ABG II stems with modular necks and 25 standard stems (control group). We measured the symmetry in hip anatomy between healthy and operated side. The anatomical restoration variables were anteversion, global offset, and femoral offset/acetabular offset (FO/AO) quota. We performed measurements using a CT-based 3D templating and measuring software. Migratory behavior of the stems was then measured postoperatively with repeated radiostereometry (RSA) examinations over 5 years.
RESULTS


Both stem types showed an early (within 3 months) good stabilization after an initial slight rotation into retroversion and subsidence. There were no significant differences in RSA migration between modular and standard stems. Postoperative anteversion and FO/AO quota had no impact on stem migration. The standard stem tended to result in insufficient global offset (GO), whereas the modular stem did not.
CONCLUSIONS


The modular stem gave good symmetrical anatomical restoration and, like the standard version, a benign migratory behavior. Anteversion, GO, and FO/AO quota had no significant impact on stem migration. It therefore seems to be of no importance whether we choose a modular or a standard stem with regard to postoperative stem migration for this stem type. We overestimated the effect anatomical parameters have on stem movement; hence, we believe the study to be underpowered.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT01512550. Registered 19 January 2012-retrospectively registered.",2020,There were no significant differences in RSA migration between modular and standard stems.,"['uncemented total hip arthroplasty', 'hip anatomy between healthy and operated side', 'Seventy-five patients with primary unilateral hip osteoarthritis operated with an uncemented anatomical stem', '75 patients and 5-year follow-up']","['standard or modular stems', 'symmetrical restoration']","['RSA migration', 'stem migration', 'anteversion, global offset, and femoral offset/acetabular offset (FO/AO) quota']","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0029410', 'cui_str': 'Osteoarthritis of hip'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}]","[{'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0333053', 'cui_str': 'Anteversion'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}]",75.0,0.0588382,There were no significant differences in RSA migration between modular and standard stems.,"[{'ForeName': 'Sverrir', 'Initials': 'S', 'LastName': 'Kiernan', 'Affiliation': 'Department of Orthopedics, Skåne University Hospital, Clinical Sciences, Lund University, Lund, Sweden. Sverrir.Kiernan@med.lu.se.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Geijer', 'Affiliation': 'Department of Radiology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sundberg', 'Affiliation': 'Department of Orthopedics, Skåne University Hospital, Clinical Sciences, Lund University, Lund, Sweden.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Flivik', 'Affiliation': 'Department of Orthopedics, Skåne University Hospital, Clinical Sciences, Lund University, Lund, Sweden.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-020-01736-0']
2685,32552731,Acupuncture for primary fibromyalgia: Study protocol of a randomized controlled trial.,"BACKGROUND


Acupuncture is well recognized for its unique therapeutic effect for many diseases as a nonpharmacological therapy in traditional Chinese medicine (TCM). However, whether acupuncture can effectively treat fibromyalgia is currently unclear. Therefore, we aim to design a study protocol of a randomized controlled clinical trial and assess the effectiveness of acupuncture for patients with fibromyalgia, which may lead to alleviation of clinical symptoms and improvement of patients' quality of life.
METHODS


The study is designed as a randomized, blinded, placebo-controlled trial of two cohorts conducted at Guang'anmen Hospital of China Academy of Chinese Medical Sciences and Shenzhen Traditional Chinese Medicine Hospital, respectively. A total of 68 patients with primary fibromyalgia, diagnosed with the American College of Rheumatology criteria, are randomly allocated with a 1:1 ratio to acupuncture or sham acupuncture groups. All subjects will receive acupuncture intervention for 8 weeks with follow-up assessments every 4 weeks for 16 weeks. The primary outcome will be evaluated using the visual analogue scale (VAS) and revised fibromyalgia impact questionnaire (FIQR) for pain intensity. The secondary outcome measures will include: Multidimensional Assessment of Fatigue scale (MAF), Short Form-36 (SF-36), Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Index (PSQI), Chinese perceived stress scales (pss-14), changes in the number of 18 tender points, patient satisfaction for the treatment and adverse events. The mentioned outcome measurements will be assessed every 4 weeks for 6 months.
DISCUSSION


This clinical trial will use advanced research methods to evaluate the efficacy and safety of acupuncture on fibromyalgia. The results of this trial may provide clinical evidence on the beneficial effects of acupuncture in treating fibromyalgia.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR1800016826: AMCTR-IOR-18000184. Registered 27 June 2018, http://www.acmctr.org/listbycreater.aspx.",2020,"A total of 68 patients with primary fibromyalgia, diagnosed with the American College of Rheumatology criteria, are randomly allocated with a 1:1 ratio to acupuncture or sham acupuncture groups.","[""two cohorts conducted at Guang'anmen Hospital of China Academy of Chinese Medical Sciences and Shenzhen Traditional Chinese Medicine Hospital, respectively"", 'patients with fibromyalgia', '68 patients with primary fibromyalgia, diagnosed with the American College of Rheumatology criteria', 'primary fibromyalgia']","['acupuncture', 'acupuncture intervention', 'acupuncture or sham acupuncture', 'Acupuncture', 'placebo']","['efficacy and safety', 'visual analogue scale (VAS) and revised fibromyalgia impact questionnaire (FIQR) for pain intensity', ' Multidimensional Assessment of Fatigue scale (MAF), Short Form-36 (SF-36), Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Index (PSQI), Chinese perceived stress scales (pss-14), changes in the number of 18 tender points, patient satisfaction for the treatment and adverse events']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0751152', 'cui_str': 'Primary fibromyalgia syndrome'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C4041113', 'cui_str': 'Assessment of fatigue'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1562820', 'cui_str': 'Tender point'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",68.0,0.50294,"A total of 68 patients with primary fibromyalgia, diagnosed with the American College of Rheumatology criteria, are randomly allocated with a 1:1 ratio to acupuncture or sham acupuncture groups.","[{'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': ""Department of Rheumatology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Jiakang', 'Initials': 'J', 'LastName': 'Cui', 'Affiliation': ""Department of Rheumatology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Yuya', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': 'Department of Rheumatology, Shenzhen Traditional Chinese Medicine Hospital, Shenzhen, China.'}, {'ForeName': 'Donghong', 'Initials': 'D', 'LastName': 'Xiao', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Jiao', 'Affiliation': ""Department of Rheumatology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Qiuwei', 'Initials': 'Q', 'LastName': 'Peng', 'Affiliation': ""Department of Rheumatology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Tian', 'Affiliation': 'Beijing CreateMed Medicine Technology Co., LTD, Beijing, China.'}, {'ForeName': 'Xiaopo', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': ""Department of Rheumatology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Jianyong', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Rheumatology, Shenzhen Traditional Chinese Medicine Hospital, Shenzhen, China. 13823396319@163.com.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': ""Department of Rheumatology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China. jiang.quan@hotmail.com.""}]",Trials,['10.1186/s13063-020-04317-y']
2686,32552775,"The ReWalk ReStore™ soft robotic exosuit: a multi-site clinical trial of the safety, reliability, and feasibility of exosuit-augmented post-stroke gait rehabilitation.","BACKGROUND


Atypical walking in the months and years after stroke constrain community reintegration and reduce mobility, health, and quality of life. The ReWalk ReStore™ is a soft robotic exosuit designed to assist the propulsion and ground clearance subtasks of post-stroke walking by actively assisting paretic ankle plantarflexion and dorsiflexion. Previous proof-of-concept evaluations of the technology demonstrated improved gait mechanics and energetics and faster and farther walking in users with post-stroke hemiparesis. We sought to determine the safety, reliability, and feasibility of using the ReStore™ during post-stroke rehabilitation.
METHODS


A multi-site clinical trial (NCT03499210) was conducted in preparation for an application to the United States Food and Drug Administration (FDA). The study included 44 users with post-stroke hemiparesis who completed up to 5 days of training with the ReStore™ on the treadmill and over ground. In addition to primary and secondary endpoints of safety and device reliability across all training activities, an exploratory evaluation of the effect of multiple exposures to using the device on users' maximum walking speeds with and without the device was conducted prior to and following the five training visits.
RESULTS


All 44 study participants completed safety and reliability evaluations. Thirty-six study participants completed all five training days. No device-related falls or serious adverse events were reported. A low rate of device malfunctions was reported by clinician-operators. Regardless of their reliance on ancillary assistive devices, after only 5 days of walking practice with the device, study participants increased both their device-assisted (Δ: 0.10 ± 0.03 m/s) and unassisted (Δ: 0.07 ± 0.03 m/s) maximum walking speeds (P's < 0.05).
CONCLUSIONS


When used under the direction of a licensed physical therapist, the ReStore™ soft exosuit is safe and reliable for use during post-stroke gait rehabilitation to provide targeted assistance of both paretic ankle plantarflexion and dorsiflexion during treadmill and overground walking.
TRIAL REGISTRATION


NCT03499210. Prospectively registered on March 28, 2018.",2020,Previous proof-of-concept evaluations of the technology demonstrated improved gait mechanics and energetics and faster and farther walking in users with post-stroke hemiparesis.,"['users with post-stroke hemiparesis', '44 users with post-stroke hemiparesis who completed up to 5 days of training with the ReStore™ on the treadmill and over ground']",['exosuit-augmented post-stroke gait rehabilitation'],"['safety and reliability evaluations', 'mobility, health, and quality of life', 'gait mechanics and energetics and faster and farther walking', 'No device-related falls or serious adverse events', 'maximum walking speeds', ""safety and device reliability across all training activities, an exploratory evaluation of the effect of multiple exposures to using the device on users' maximum walking speeds""]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018989', 'cui_str': 'Hemiparesis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0040606', 'cui_str': 'Training Activities'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]",44.0,0.124064,Previous proof-of-concept evaluations of the technology demonstrated improved gait mechanics and energetics and faster and farther walking in users with post-stroke hemiparesis.,"[{'ForeName': 'Louis N', 'Initials': 'LN', 'LastName': 'Awad', 'Affiliation': 'Department of Physical Therapy & Athletic Training, Boston University, Boston, MA, USA. louawad@bu.edu.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Esquenazi', 'Affiliation': 'Department of PM&R, MossRehab and Einstein Healthcare Network, Elkins Park, PA, USA.'}, {'ForeName': 'Gerard E', 'Initials': 'GE', 'LastName': 'Francisco', 'Affiliation': 'Department of PM&R, University of Texas McGovern Medical School, TIRR Memorial Hermann, Houston, TX, USA.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Nolan', 'Affiliation': 'Center for Mobility and Rehabilitation Engineering, Kessler Foundation, West Orange, NJ, USA.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Jayaraman', 'Affiliation': 'Department of PM&R, Northwestern University, Chicago, IL, USA. ajayaraman@sralab.org.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00702-5']
2687,32549718,Comparison of Intraocular Pressure Changes Due to Exposure to Mobile Phone Electromagnetics Radiations in Normal and Glaucoma Eye.,"PURPOSE


The aim of this study is to investigate the effects of electromagnetic waves (EMWs) emitted by a mobile phone on the intraocular pressure (IOP) in the eyeball.
METHODS


This quasi-experimental study was conducted on 166 eyes from 83 individuals in the 40-70 age range who referred to ""Khatam-al-Anbia Hospital, Mashhad, Iran"" in 2016. There were two groups of participants, and the first one consisted of 41 participants who had normal eyes, whereas the second one comprised 42 participants who suffered from open-angle glaucoma disease. The IOP in both groups was measured and recorded by a specialist before and after talking 5 min on the cellphone with the help of the Goldman method. Statistical analysis such as paired  t -test and analysis of variance was performed and all tests are statistically significant at ( P  < 0.05). For this purpose, the SPSS software (version 16) was applied.
RESULTS


IOP in the glaucoma eye (42 eyes) ipsilateral to mobile phone before and after the intervention was 18.64 ± 6.7 and 23.53 ± 6.3, respectively ( P  < 0.001). However, IOP in the control group (41 eyes) ipsilateral to mobile phone before and after the intervention was 12.95 ± 3.5 and 13.39 ± 2.8, respectively ( P  = 0.063). IOP change in the opposite glaucomatous eye to mobile phone in glaucoma group (39 eyes) and normal group (44 eyes) was not significantly different before and after the phone call ( P  = 0.065 and  P  = 0.85, respectively).
CONCLUSION


We found that the acute effects of EMWs emitted from the mobile phones can significantly increase the IOP in glaucoma eye, while such changes were not observed in normal eyes.",2020,"RESULTS


IOP in the glaucoma eye (42 eyes) ipsilateral to mobile phone before and after the intervention was 18.64 ± 6.7 and 23.53 ± 6.3, respectively ( P  < 0.001).","['41 participants who had normal eyes, whereas the second one comprised 42 participants who suffered from open-angle glaucoma disease', '166 eyes from 83 individuals in the 40-70 age range who referred to ""Khatam-al-Anbia Hospital, Mashhad, Iran"" in 2016', 'Normal and Glaucoma Eye']","['electromagnetic waves (EMWs', 'Intraocular Pressure Changes Due to Exposure to Mobile Phone Electromagnetics Radiations']","['intraocular pressure (IOP', 'IOP change', 'IOP in glaucoma eye']","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0857112', 'cui_str': 'Bilateral glaucoma'}]","[{'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}]","[{'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0857112', 'cui_str': 'Bilateral glaucoma'}]",41.0,0.0447543,"RESULTS


IOP in the glaucoma eye (42 eyes) ipsilateral to mobile phone before and after the intervention was 18.64 ± 6.7 and 23.53 ± 6.3, respectively ( P  < 0.001).","[{'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Shokoohi-Rad', 'Affiliation': 'Eye Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammad-Rez', 'Initials': 'MR', 'LastName': 'Ansari', 'Affiliation': 'Eye Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Sabzi', 'Affiliation': 'Eye Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Rahim', 'Initials': 'R', 'LastName': 'Saffari', 'Affiliation': 'Eye Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Rajaei', 'Affiliation': 'Eye Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Farshid', 'Initials': 'F', 'LastName': 'Karimi', 'Affiliation': 'Department of Optometry, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Middle East African journal of ophthalmology,['10.4103/meajo.MEAJO_20_19']
2688,32549724,Intraoperative Evaluation of Phacoemulsification Cataract Surgery with and without the Use of Ophthalmic Viscosurgical Devices.,"PURPOSE


The purpose of this study was to compare the efficacy and safety of cataract surgery by the phacoemulsification technique with and without the use of ophthalmic viscosurgical devices (OVDs).
SETTING


This study was conducted at a tertiary eye care center in a rural area of Central India.
DESIGN


This was a prospective, randomized, observational study.
METHODS


In this study, 220 patients underwent phacoemulsification for cataract surgery with OVDs (OVD group) or without OVDs (BSS group) ( n  = 110 in each group). Patients with operable, nuclear Grade 2-4 cataracts were included in the study. The study was conducted from June 2017 to September 2018. The frequency of intraoperative complications, surgical time, and ease of the surgical procedure (easy, difficult, or very difficult) were recorded.
RESULTS


There was no statistically significant difference in the nuclear opalescence, axial length, and intraocular lens (IOL) power between the two groups. Capsulorhexis extension was seen in two eyes in the OVD group and none of the eyes in the BSS group. The problems that occurred during IOL implantation included flip (OVD group, 2; BSS group, 1), haptic breakage (OVD group, 1; BSS group, 1), sulcus implantation (OVD group, 0; BSS group, 2), and stuck haptic (OVD group, 1; BSS group, 3). The total surgical time was almost equal in the two groups (OVD group, 9.2 min ± 3; BSS group, 9.5 min ± 3.5;  P  = 0.521). None of the patients had iris trauma or posterior capsular rupture.
CONCLUSIONS


OVD-less phacoemulsification surgery is a safe and effective technique for treating age-related cataracts that requires no additional instrumentation and saves the cost of the OVD.",2020,"There was no statistically significant difference in the nuclear opalescence, axial length, and intraocular lens (IOL) power between the two groups.","['This study was conducted at a tertiary eye care center in a rural area of Central India', 'Patients with operable, nuclear Grade 2-4 cataracts', 'June 2017 to September 2018', '220 patients underwent']","['Phacoemulsification Cataract Surgery', 'Ophthalmic Viscosurgical Devices', 'OVD-less phacoemulsification surgery', 'ophthalmic viscosurgical devices (OVDs', 'cataract surgery', 'phacoemulsification for cataract surgery with OVDs (OVD group) or without OVDs (BSS group) ( n']","['iris trauma or posterior capsular rupture', 'nuclear opalescence, axial length, and intraocular lens (IOL) power', 'efficacy and safety', 'total surgical time', 'Capsulorhexis extension', 'frequency of intraoperative complications, surgical time, and ease of the surgical procedure (easy, difficult, or very difficult']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0885957', 'cui_str': 'Eye care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C4517650', 'cui_str': '220'}]","[{'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0005129', 'cui_str': 'Bernard Soulier syndrome'}]","[{'cui': 'C0022077', 'cui_str': 'Iris structure'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C1626910', 'cui_str': 'Posterior capsular rupture'}, {'cui': 'C0296695', 'cui_str': 'tooth-bleaching agent, Opalescence'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0525027', 'cui_str': 'Anterior capsulorrhexis'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}]",220.0,0.0458724,"There was no statistically significant difference in the nuclear opalescence, axial length, and intraocular lens (IOL) power between the two groups.","[{'ForeName': 'Rajesh Subhash', 'Initials': 'RS', 'LastName': 'Joshi', 'Affiliation': 'Department of Ophthalmology, Vasantrao Naik Government Medical College, Yavatmal, Maharashtra, India.'}, {'ForeName': 'Sanoja Rangnath', 'Initials': 'SR', 'LastName': 'Naik', 'Affiliation': 'Department of Ophthalmology, Vasantrao Naik Government Medical College, Yavatmal, Maharashtra, India.'}]",Middle East African journal of ophthalmology,['10.4103/meajo.MEAJO_140_19']
2689,32549995,"Study protocol for POSITIF, a randomised multicentre feasibility trial of a brief cognitive-behavioural intervention plus information versus information alone for the treatment of post-stroke fatigue.","Background


Approximately, half of stroke survivors experience fatigue. Fatigue may persist for many months and interferes with participation in everyday activities and has a negative impact on social and family relationships, return to work, and quality of life. Fatigue is among the top 10 priorities for 'Life after Stroke' research for stroke survivors, carers, and clinicians. We previously developed and tested in a small uncontrolled pilot study a manualised, clinical psychologist-delivered, face-to-face intervention, informed by cognitive behavioural therapy (CBT). We then adapted it for delivery by trained therapists via telephone. We now aim to test the feasibility of this approach in a parallel group, randomised controlled feasibility trial ( P ost  S troke  I ntervention  T rial  I n  F atigue, POSITIF).
Methods/design


POSITIF aims to recruit 75 stroke survivors between 3 months and 2 years post-stroke who would like treatment for their fatigue. Eligible consenting stroke survivors will be randomised to either a 7-session manualised telephone-delivered intervention based on CBT principles plus information about fatigue, or information only. The aims of the intervention are to (i) provide an explanation for post-stroke fatigue, in particular that it is potentially reversible (an educational approach), (ii) encourage participants to overcome the fear of taking physical activity and challenge negative thinking (a cognitive approach) and (iii) promote a balance between daily activities, rest and sleep and then gradually increase levels of physical activity (a behavioural approach). Fatigue, mood, quality of life, return to work and putative mediators will be assessed at baseline (just before randomisation), at the end of treatment and 6 months after randomisation. POSITIF will determine the feasibility of recruitment, adherence to the intervention and the resources required to deliver the intervention in a larger trial.
Discussion


The POSITIF feasibility trial will recruit until 31 January 2020. Data will inform the utility and design of a future adequately powered randomised controlled trial.
Trial registration


ClinicalTrials.gov, NCT03551327. Registered on 11 June 2018.",2020,"Eligible consenting stroke survivors will be randomised to either a 7-session manualised telephone-delivered intervention based on CBT principles plus information about fatigue, or information only.","['Eligible consenting stroke survivors', 'post-stroke fatigue', '75 stroke survivors between 3\u2009months and 2\u2009years post-stroke who would like treatment for their fatigue']","['7-session manualised telephone-delivered intervention based on CBT principles plus information about fatigue, or information only', 'cognitive-behavioural intervention plus information versus information alone', 'cognitive behavioural therapy (CBT', 'I ntervention']","['Fatigue, mood, quality of life, return to work and putative mediators', 'T rial']","[{'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}]",,0.197887,"Eligible consenting stroke survivors will be randomised to either a 7-session manualised telephone-delivered intervention based on CBT principles plus information about fatigue, or information only.","[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Gillespie', 'Affiliation': 'Department of Clinical Neurosciences, Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Barber', 'Affiliation': 'NHS Lanarkshire, Monklands Hospital, Coatbridge, UK.'}, {'ForeName': 'Marian C', 'Initials': 'MC', 'LastName': 'Brady', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Carson', 'Affiliation': 'Department of Clinical Neurosciences, Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Trudie', 'Initials': 'T', 'LastName': 'Chalder', 'Affiliation': ""Department of Psychological Medicine, King's College London, London, UK.""}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Chun', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Cvoro', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Dennis', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Maree', 'Initials': 'M', 'LastName': 'Hackett', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Euan', 'Initials': 'E', 'LastName': 'Haig', 'Affiliation': 'Independent Consultant, Edinburgh, UK.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'House', 'Affiliation': 'Faculty of Medicine and Health, University of Leeds, Leeds, UK.'}, {'ForeName': 'Steff', 'Initials': 'S', 'LastName': 'Lewis', 'Affiliation': 'Edinburgh Clinical Trials Unit (ECTU), University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Parker', 'Affiliation': 'Edinburgh Clinical Trials Unit (ECTU), University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Wee', 'Affiliation': 'Edinburgh Clinical Trials Unit (ECTU), University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Simiao', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, West China Hospital, Chengdu, China.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Mead', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00622-0']
2690,32549996,A randomised feasibility study of serial magnetic resonance imaging to reduce treatment times in Charcot neuroarthropathy in people with diabetes (CADOM): a protocol.,"Background


Charcot neuroarthropathy is a complication of peripheral neuropathy associated with diabetes which most frequently affects the lower limb. It can cause fractures and dislocations within the foot, which may progress to deformity and ulceration. Recommended treatment is immobilisation and offloading, with a below knee non-removable cast or boot. Duration of treatment varies from six months to more than 1 year. Small observational studies suggest that repeated assessment with magnetic resonance imaging improves decision-making about when to stop treatment, but this has not been tested in clinical trials. This study aims to explore the feasibility of using serial magnetic resonance imaging without contrast in the monitoring of Charcot neuroarthropathy to reduce duration of immobilisation of the foot. A nested qualitative study aims to explore participants' lived experience of Charcot neuroarthropathy and of taking part in the feasibility study.
Methods


We will undertake a two-arm, open study and randomise 60 people with a suspected or confirmed diagnosis of Charcot neuroarthropathy from five NHS, secondary care multidisciplinary Diabetic Foot Clinics across England. Participants will be randomised 1:1 to receive magnetic resonance imaging at baseline and remission up to 12 months, with repeated foot temperature measurements and X-rays (standard care plus), or standard care plus with additional three-monthly magnetic resonance imaging until remission up to 12 months (intervention). Time to confirmed remission of Charcot neuroarthropathy with off-loading treatment (days) and its variance will be used to inform sample size in a full-scale trial. We will look for opportunities to improve the protocols for monitoring techniques and the clinical, patient-centred and health economic measures used in a future study. For the nested qualitative study, we will invite a purposive sample of 10-14 people able to offer maximally varying experiences from the feasibility study to take part in semi-structured interviews to be analysed using thematic analysis.
Discussion


The study will inform the decision whether to proceed to a full-scale trial. It will also allow deeper understanding of the lived experience of Charcot neuroarthropathy, and factors that contribute to engagement in management and contribute to the development of more effective patient-centred strategies.
Trial registration


ISRCTN, ISRCTN74101606. Registered on 6 November 2017.",2020,Time to confirmed remission of Charcot neuroarthropathy with off-loading treatment (days) and its variance will be used to inform sample size in a full-scale trial.,"[""participants' lived experience of Charcot neuroarthropathy and of taking part in the feasibility study"", 'people with diabetes (CADOM', 'Charcot', '60 people with a suspected or confirmed diagnosis of Charcot neuroarthropathy from five NHS, secondary care multidisciplinary Diabetic Foot Clinics across England']","['magnetic resonance imaging', 'serial magnetic resonance imaging', 'magnetic resonance imaging at baseline and remission up to 12\u2009months, with repeated foot temperature measurements and X-rays (standard care plus), or standard care plus with additional three-monthly magnetic resonance imaging until remission', 'neuroarthropathy']",[],"[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0015730', 'cui_str': 'Feasibility Studies'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0206172', 'cui_str': 'Diabetic foot'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With'}]",[],,0.133385,Time to confirmed remission of Charcot neuroarthropathy with off-loading treatment (days) and its variance will be used to inform sample size in a full-scale trial.,"[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Gooday', 'Affiliation': 'School of Health Sciences, University of East Anglia, Norwich, NR4 7TJ UK.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Game', 'Affiliation': 'Department of Diabetes and Endocrinology, University Hospitals of Derby and Burton NHS Foundation Trust, Derby, DE22 3NE UK.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Woodburn', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, G4 0BA UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Poland', 'Affiliation': 'School of Health Sciences, University of East Anglia, Norwich, NR4 7TJ UK.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Sims', 'Affiliation': 'Norwich Clinical Trials Unit, Norwich Medical School, University of East Anglia, Norwich, NR4 7TJ UK.'}, {'ForeName': 'Ketan', 'Initials': 'K', 'LastName': 'Dhatariya', 'Affiliation': 'Elsie Bertram Diabetes Centre, Norfolk & Norwich University Hospitals NHS Foundation Trust, Norwich, NR4 7UY UK.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Shepstone', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, NR4 7TJ UK.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Hardeman', 'Affiliation': 'School of Health Sciences, University of East Anglia, Norwich, NR4 7TJ UK.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00611-3']
2691,32550007,Comparison of antibacterial effectiveness of three rotary file system with different geometry in infected root canals before and after instrumentation-a double-blinded randomized controlled clinical trial.,"Introduction


To compare the antibacterial effectiveness of three rotary file systems i.e., ProTaper Next, ProTaper Gold and XP-endo Shaper in root canals of teeth with asymptomatic apical periodontitis by using the real-time polymerase chain reaction.
Materials and methods


Root canals from single or multi-rooted teeth (straight canals) with necrotic pulps and asymptomatic apical periodontitis were instrumented using either ProTaper Next ( n  = 20), ProTaper Gold ( n  = 20) and XP-endo Shaper ( n  = 20) under irrigation with 3% sodium hypochlorite. Samples obtained before and after instrumentation were subjected to DNA extraction, amplification and quantitation of total amount of bacteria by using the real-time polymerase chain reaction.
Results


Samples were taken before preparation (S1) were positive for presence of bacteria, with mean numbers of 9.94 × 10 7 , 20.4 × 10 7  and 9.20 × 10 7  bacterial cells for the ProTaper Next, ProTaper Gold and XP-endo Shaper groups, respectively. After preparation (S2) with ProTaper Next, ProTaper Gold, and XP-endo Shaper, root canals still had bacteria with mean counts of 11.8 × 10 5 , 87.2 × 10 5  and 4.52 × 10 5  bacterial cells, respectively. Both XP-endo Shaper (99.50%) and ProTaper Next (98.81%) were effective in reducing total bacterial count, and there was no statistically significant difference between them ( P  > 0.05). XP-endo Shaper succeeded in reducing total bacterial count than ProTaper Gold (95.72%) and there exists statistically significant difference between them ( P  < 0.05).
Conclusions


XP-endo Shaper was highly effective in reducing total bacterial count from root canals of teeth with asymptomatic apical periodontitis than ProTaper Gold. ProTaper Next also showed improved microbial reduction percentage as compared with ProTaper Gold.",2020,"Conclusions


XP-endo Shaper was highly effective in reducing total bacterial count from root canals of teeth with asymptomatic apical periodontitis than ProTaper Gold.","['×\u200910 7 , 20.4', 'Materials and methods\n\n\nRoot canals from single or multi-rooted teeth (straight canals) with necrotic pulps and asymptomatic apical periodontitis']","['XP-endo Shaper ( n \u2009=\u200920) under irrigation with 3% sodium hypochlorite', 'ProTaper', 'ProTaper Next, ProTaper Gold and XP-endo Shaper']","['total bacterial count', 'antibacterial effectiveness', 'microbial reduction percentage']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0011407', 'cui_str': 'Necrosis of the pulp'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0031030', 'cui_str': 'Apical periodontitis'}]","[{'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0037518', 'cui_str': 'sodium hypochlorite'}, {'cui': 'C0018026', 'cui_str': 'Gold'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004618', 'cui_str': 'Bacterial count'}, {'cui': 'C0279516', 'cui_str': 'Antibacterial'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",,0.0673868,"Conclusions


XP-endo Shaper was highly effective in reducing total bacterial count from root canals of teeth with asymptomatic apical periodontitis than ProTaper Gold.","[{'ForeName': 'Riluwan', 'Initials': 'R', 'LastName': 'Siddique', 'Affiliation': 'Saveetha Dental College, Poonamalle High Road, Chennai, Tamil Nadu 600056 India.'}, {'ForeName': 'Malli Sureshbabu', 'Initials': 'MS', 'LastName': 'Nivedhitha', 'Affiliation': 'Saveetha Dental College, Poonamalle High Road, Chennai, Tamil Nadu 600056 India.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Ranjan', 'Affiliation': 'Saveetha Dental College, Poonamalle High Road, Chennai, Tamil Nadu 600056 India.'}, {'ForeName': 'Benoy', 'Initials': 'B', 'LastName': 'Jacob', 'Affiliation': 'Saveetha Dental College, Poonamalle High Road, Chennai, Tamil Nadu 600056 India.'}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Solete', 'Affiliation': 'Saveetha Dental College, Poonamalle High Road, Chennai, Tamil Nadu 600056 India.'}]",BDJ open,['10.1038/s41405-020-0035-7']
2692,32550017,The Effect of Brief Supportive Psychotherapy on Prevention of Psychiatric Morbidity in Women with Miscarriage: A Randomized Controlled Trial about the First 24-hours of Hospitalization.,"Objectives


Miscarriage is a common pregnancy complication causing substantial psychiatric complications. This study was designed to investigate whether the administration of brief supportive psychotherapy (BSP) is effective on the management of women with miscarriage when conducted in the first 24 hours of hospitalization in order to prevent symptoms of anxiety, depression, and grief at four-months post-miscarriage.
Methods


We conducted a randomized clinical trial on 79 women with miscarriage hospitalized in Ayatollah Rohani teaching hospital. The women were randomly assigned into two groups (39 in the experimental group and 40 in the control group). All interventions were implemented for two study groups during the first 24 hours of hospitalization in a private room in the hospital. The experimental group received a two-hour BSP. The objective outcomes were assessed using Hospital Anxiety and Depression Scale and Perinatal Grief Scale (PGS), which has three subscales (active grief, difficulty coping, and despair) and were measured before the intervention and at four-months post-miscarriage.
Results


The results of pre-tests in the follow-up of the trial suggested that the participants who received BSP reported significant reductions in the mean scores of active grief (-34.2±9.7 vs. 28.1±-6.9), difficulty coping (27.1±6.4 vs. 23.3±4.3), despair (28.0±8.4 vs. 22.8±5.2), and total PGS (89.6±23.1 vs. 74.4±15.3), in contrast to participants in the control group who did not report such results. Further, the results of generalized estimating equations models revealed that brief supportive psychotherapy caused a significant decrease in the level of factors including active grief, difficulty coping, despair, total perinatal grief, anxiety symptoms, and depressive symptoms in subjects in the experimental group compared to those in the control group after miscarriage. Also, the frequency of anxiety symptoms (13.5% vs. 60.5%), depressive symptoms (32.4% vs. 71.1%), and grief symptoms (10.8% vs. 65.8%) was found to be significantly lower in the group receiving psychotherapy than in the control group at four-months follow-up.
Conclusions


Administration of BSP session during the first 24 hours of hospitalization for women with miscarriage can be considered a reliable method to prevent anxiety symptoms, depression symptoms, and perinatal grief at four-months follow-up.",2020,"Also, the frequency of anxiety symptoms (13.5% vs. 60.5%), depressive symptoms (32.4% vs. 71.1%), and grief symptoms (10.8% vs. 65.8%) was found to be significantly lower in the group receiving psychotherapy than in the control group at four-months follow-up.
","['Women with Miscarriage', '79 women with miscarriage hospitalized in Ayatollah Rohani teaching hospital', 'women with miscarriage when conducted in the first 24 hours of hospitalization in order to prevent symptoms of anxiety, depression, and grief at four-months post-miscarriage', 'women with miscarriage']","['BSP session', 'Supportive Psychotherapy', 'psychotherapy', 'BSP', 'supportive psychotherapy (BSP']","['frequency of anxiety symptoms', 'difficulty coping', 'level of factors including active grief, difficulty coping, despair, total perinatal grief, anxiety symptoms, and depressive symptoms', 'depressive symptoms', 'Psychiatric Morbidity', 'grief symptoms', 'anxiety symptoms, depression symptoms, and perinatal grief', 'mean scores of active grief', 'total PGS', 'Hospital Anxiety and Depression Scale and Perinatal Grief Scale (PGS), which has three subscales (active grief, difficulty coping, and despair']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0018235', 'cui_str': 'Normal grief reaction'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0221295', 'cui_str': 'Supportive psychotherapy'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0582154', 'cui_str': 'Difficulty coping'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0018235', 'cui_str': 'Normal grief reaction'}, {'cui': 'C0233488', 'cui_str': 'Feeling despair'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}]",79.0,0.0752924,"Also, the frequency of anxiety symptoms (13.5% vs. 60.5%), depressive symptoms (32.4% vs. 71.1%), and grief symptoms (10.8% vs. 65.8%) was found to be significantly lower in the group receiving psychotherapy than in the control group at four-months follow-up.
","[{'ForeName': 'Shahnaz', 'Initials': 'S', 'LastName': 'Barat', 'Affiliation': 'Department of Obstetrics and Gynecology, Cancer Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Shahla', 'Initials': 'S', 'LastName': 'Yazdani', 'Affiliation': 'Department of Obstetrics and Gynecology, Cancer Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Mahbobeh', 'Initials': 'M', 'LastName': 'Faramarzi', 'Affiliation': 'Social Determinants of Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Soraya', 'Initials': 'S', 'LastName': 'Khafri', 'Affiliation': 'Department of Biostatistics and Epidemiology, Infertility and Reproductive Health Research Center, Health Research Institute, Faculty of Medicine, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Darvish', 'Affiliation': 'Clinical Research Development Unit of Rohani Hospital, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Mojgan Naeimi', 'Initials': 'MN', 'LastName': 'Rad', 'Affiliation': 'Clinical Research Development Unit of Rohani Hospital, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Nesa', 'Initials': 'N', 'LastName': 'Asnafi', 'Affiliation': 'Department of Obstetrics and Gynecology, Cancer Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}]",Oman medical journal,['10.5001/omj.2020.48']
2693,32550158,Safety and efficacy of Berberis integerrima root extract in patients with type 2 diabetes. A parallel intervention based triple blind clinical trial.,"Purpose


To evaluate the safety and efficacy of methanol extract of  Berberis integerrima  root on type 2 diabetes compared to metformin.
Methods


In a parallel triple blind clinical trial, 80 type 2 diabetic patients,, were randomized into two groups (treated with Berberis integerrima root, 480 mg (oral), compared to control group treated with metformin 1000 mg daily). Efficacy was evaluated by fasting and prandial glucose and HbA1c and side effects confirmed by physical examination, biology and hematology tests and urinalysis on days 15, 45 and 90. They were followed for 3 months.
Results


Two hundred and eighteen patients were recruited and 80 (55female and 25 male) patients randomized in two groups and 60 patient were analysed. The mean age of patients was 51.8 ± 9.3 and 46.5 ± 10 in the experimental ( Berberis integerrima   )  and control (metformin) groups respectively ( P  = 0.02). The mean HbA1c at baseline was 8.1 ± 1.6% and 7.9 ± 1.6% for  B. integerrima  and metformin group respectively (P = 0.53), and there was no significant difference between the two groups (7.5 vs. 7.2) after 3 months (P = 0.34).Weight loss was observed in both groups compared to baseline.No adverse event led to preventing the study was reported.
Conclusion


Berberis integerrima  root not only was effective as much as metformin in reducing blood glucose and controlling type 2 diabetes but also, no specific side effect was reported (in short term).So, it might be an effective and safe complementary therapy in diabetic patients.Iranian Research and Clinical Trial (IRCT) registeration number; 201,207,191,774 N5.Funding: Vice chancellor for research, Physiology Research Center of Kerman University of Medical Sciences and the Exir pharmaceutical company.",2020,P = 0.34).Weight loss was observed in both groups compared to baseline.,"['80 type 2 diabetic patients', 'Two hundred and eighteen patients were recruited and 80 (55female and 25 male) patients randomized in two groups and 60 patient were analysed', 'patients with type 2 diabetes', 'diabetic patients']","['control (metformin', 'Berberis integerrima root extract', 'metformin', 'Berberis integerrima root, 480\xa0mg (oral), compared to control group treated with metformin 1000\xa0mg daily', 'methanol extract']","['fasting and prandial glucose and HbA1c and side effects', 'blood glucose', 'Efficacy', 'Safety and efficacy', 'mean HbA1c']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0949843', 'cui_str': 'Barberry'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001963', 'cui_str': 'Methanol'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",218.0,0.0348354,P = 0.34).Weight loss was observed in both groups compared to baseline.,"[{'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Sanjari', 'Affiliation': 'Associate Professor of endocrinology and metabolism, Endocrinology and metabolism Research Center, institute of Basic and clinical physiology Sciences, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Behrang', 'Initials': 'B', 'LastName': 'Shamsinejad', 'Affiliation': 'Physiology Research Center, Institute of Basic and Clinical Physiology Sciences, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Payam', 'Initials': 'P', 'LastName': 'Khazaeli', 'Affiliation': 'Pharmaceutical Research Center, School of Pharmacy,Kerman University of Medical Sciences, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Safi', 'Affiliation': 'Cardiovascular Research Center, Institute of Basic and Clinical Physiology Sciences, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Mirrashidi', 'Affiliation': 'pediatrices, Endocrinology and metabolism Research Center, institute of Basic and clinical physiology Sciences, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Naghibzadeh-Tahami', 'Affiliation': 'Modeling in Health Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran.'}]",Journal of diabetes and metabolic disorders,['10.1007/s40200-019-00478-z']
2694,32550179,"High-dose thiamine supplementation may reduce resting energy expenditure in individuals with hyperglycemia: a randomized, double - blind cross-over trial.","Background


Despite the crucial role of thiamine in glucose and energy metabolism pathways, there has been no published study examining the impact of thiamine on energy metabolism in humans.
Objective


To assess the effects of thiamine supplementation on resting energy expenditure (REE) in individuals with hyperglycemia.
Methods


Twelve hyperglycemic patients completed this double-blind, randomized trial, where all participants received both thiamine (300 mg/day) and matched placebo for 6 weeks in a cross-over manner. REE was assessed by indirect calorimetry. Anthropometric measurements, fasting and 2-h plasma glucose, and glucose-induced thermogenesis were also assessed at the beginning and on the completion of each six-week phase.
Results


Participants consuming thiamine supplements experienced a significant decrease in the REE assessed at week six compared to the baseline [mean (SE): 1478.93 (73.62) vs.1526.40 (73.46) kcal/d,  p  = 0.02], and the placebo arm ( p  = 0.002). These results did not change significantly after adjusting for the participants' body weight and physical activity as potential confounders. Six-week intervention had no significant effect on the participants' body weight or waist circumference, in either supplement or placebo arms (all  p  values>0.05). However, correlation analysis highlighted significant positive relationships between the changes in REE, and those in fasting (r s  = 0.497,  p  = 0.019) and 2-h plasma glucose (r s  = 0.498,  p  = 0.018) during the six-week intervention period.
Conclusion


Supplementation with high-dose thiamine may attenuate REE in patients with impaired glucose regulation. Our findings suggest that the impact of thiamine on REE may in part be explained by improved glycemic control.
Trial registration


Australian New Zealand Clinical Trials Registry ACTRN12611000051943. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12611000051943.",2020,"Six-week intervention had no significant effect on the participants' body weight or waist circumference, in either supplement or placebo arms (all  p  values>0.05).","['individuals with hyperglycemia', 'Methods\n\n\nTwelve hyperglycemic patients', 'patients with impaired glucose regulation']","['thiamine supplementation', 'thiamine', 'placebo']","['REE', 'Anthropometric measurements, fasting and 2-h plasma glucose, and glucose-induced thermogenesis', '2-h plasma glucose', ""participants' body weight or waist circumference"", 'resting energy expenditure (REE']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0220905', 'cui_str': 'regulations'}]","[{'cui': 'C4524016', 'cui_str': 'Thiamin supplementation'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0018841', 'cui_str': 'Heat Production'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}]",12.0,0.598071,"Six-week intervention had no significant effect on the participants' body weight or waist circumference, in either supplement or placebo arms (all  p  values>0.05).","[{'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Alaei-Shahmiri', 'Affiliation': 'Endocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences (IUMS), No 10, Firouzeh St. Vali-Asr St., Tehran, Iran.'}, {'ForeName': 'Mario J', 'Initials': 'MJ', 'LastName': 'Soares', 'Affiliation': 'School of Public Health, Curtin University, Perth, Western Australia 6102 Australia.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Lahouti', 'Affiliation': 'Endocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences (IUMS), No 10, Firouzeh St. Vali-Asr St., Tehran, Iran.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'School of Public Health, Curtin University, Perth, Western Australia 6102 Australia.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Sherriff', 'Affiliation': 'School of Public Health, Curtin University, Perth, Western Australia 6102 Australia.'}]",Journal of diabetes and metabolic disorders,['10.1007/s40200-020-00508-1']
2695,32550181,The effects of mindfulness training on the level of happiness and blood sugar in diabetes patients.,"Purpose


The present study aimed at investigating the effect of mindfulness training on the level of happiness and blood glucose in diabetic patients in Zarghan city, Iran.
Methods


This quasi-experimental study was conducted in 2018 in Fars province, Iran. 136 diabetic patients who were eligible (had diabetes for more than one year, older than 18 years, willingness to participate in the research, and reside in Zarqan city) were selected based on convenience sampling method. Next the participants were randomly divided into two groups, each comprising 68 individuals. Both of the study samples and statistical analyser were blinded to intervention group (mindfulness training) and control group (without intervention). Before and three month after the intervention the patients' levels of happiness (based on Oxford Happiness Questionnaire), fasting blood sugar (FBS) and Glycated Hemoglobin test (HbA1c) were measured.
Results


The results indicated that after the sessions, the level of happiness in the Intervention group was significantly higher than the control group ( p  value <0.001). Also, the level of blood glucose and HbA1c after the sessions was significantly lower in the Intervention group compared to the control group (p value<0.001, p value = 0.004). After the intervention, there was a significant correlation between mean blood glucose levels and mean HbA1c levels in the Intervention group and their level of happiness (p value<0.01 and p value<0.001).
Conclusion


The findings revealed that the mindfulness-based educational intervention can increase happiness in people with diabetes and regulate their blood glucose.",2020,"After the intervention, there was a significant correlation between mean blood glucose levels and mean HbA1c levels in the Intervention group and their level of happiness (p value<0.01 and p value<0.001).
","['diabetic patients in Zarghan city, Iran', 'diabetes patients', '136 diabetic patients who were eligible (had diabetes for more than one year, older than 18\xa0years, willingness to participate in the research, and reside in Zarqan city', '2018 in Fars province, Iran']","['mindfulness-based educational intervention', 'mindfulness training']","['mean blood glucose levels and mean HbA1c levels', 'level of happiness and blood sugar', 'level of happiness', 'levels of happiness (based on Oxford Happiness Questionnaire), fasting blood sugar (FBS) and Glycated Hemoglobin test (HbA1c', 'level of happiness and blood glucose', 'level of blood glucose and HbA1c']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205108', 'cui_str': 'Distal'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}]",136.0,0.0120063,"After the intervention, there was a significant correlation between mean blood glucose levels and mean HbA1c levels in the Intervention group and their level of happiness (p value<0.01 and p value<0.001).
","[{'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Zarifsanaiey', 'Affiliation': 'Department of E-learning, Virtual School, Comprehensive Center of Excellence for e-Learning in Medical Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Khadijah', 'Initials': 'K', 'LastName': 'Jamalian', 'Affiliation': 'Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Bazrafcan', 'Affiliation': 'Clinical Education Research Centre, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Keshavarzy', 'Affiliation': 'Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Hadi Raeisi', 'Initials': 'HR', 'LastName': 'Shahraki', 'Affiliation': 'Department of Epidemiology and Biostatistics, Faculty of Health, Shahrekord University of Medical Sciences, Shahrekord, Iran.'}]",Journal of diabetes and metabolic disorders,['10.1007/s40200-020-00510-7']
2696,32550183,Transcranial direct current stimulation improves quality of life and physical fitness in diabetic polyneuropathy: a pilot double blind randomized controlled trial.,"Purpose


Diabetes Mellitus (DM) is a chronic disease which presents a big prevalence in the world and several patients with this condition fail to respond to the available treatments. There is a huge unmet clinical need for the development of new therapeutic approaches for this condition. This study aims to evaluate the effects of anodal tDCS on Quality of Life and physical fitness in patients with diabetic polyneuropathy.
Methods


A pilot, parallel, sham, randomized, double-blind trial was conducted with twenty patients. Five consecutive sessions of C3/Fp2 tDCS montage were performed. To assess the primary outcome Short Form 36 Health Survey (SF-36) was used. Physical fitness level, according to lower and upper body strength, flexibility, Time Up and Go Test (TUG) and Six-Minute Walking Test (6MWT) were measured as secondary outcomes. The measures were performed at 3 different times (baseline, 1st and 2nd weeks).
Results


SF-36 increased throughout the protocol, but no difference between groups were found. However, there was a significant difference between groups at 1st and 2nd weeks, which shows a permanent growth in the active-tDCS group. Physical health and functioning, functional capacity and bodily pain showed significant improvements in active-tDCS group in 1st and 2nd weeks during inter-group analysis. Emotional scores showed significant interaction group-time with interaction effects only for active-group in 1st and 2nd weeks. TUG and 6MWT showed significant improvements only in active-tDCS group.
Conclusions


It is suggested that five sessions of anodal M1 tDCS improves QoL and functionality of patients with diabetic polyneuropathy.",2020,"Physical health and functioning, functional capacity and bodily pain showed significant improvements in active-tDCS group in 1st and 2nd weeks during inter-group analysis.","['patients with diabetic polyneuropathy', 'diabetic polyneuropathy', 'twenty patients']","['Transcranial direct current stimulation', 'C3/Fp2 tDCS montage', 'anodal tDCS', 'anodal M1 tDCS']","['SF-36', 'QoL and functionality', 'Physical health and functioning, functional capacity and bodily pain', 'Quality of Life and physical fitness', 'quality of life and physical fitness', 'Emotional scores', 'Physical fitness level, according to lower and upper body strength, flexibility, Time Up and Go Test (TUG) and Six-Minute Walking Test (6MWT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271680', 'cui_str': 'Diabetic polyneuropathy'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1268087', 'cui_str': 'Upper body structure'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439232', 'cui_str': 'min'}]",,0.260108,"Physical health and functioning, functional capacity and bodily pain showed significant improvements in active-tDCS group in 1st and 2nd weeks during inter-group analysis.","[{'ForeName': 'Galeno', 'Initials': 'G', 'LastName': 'Ferreira', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte Brazil.'}, {'ForeName': 'Edson', 'Initials': 'E', 'LastName': 'Silva-Filho', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte Brazil.'}, {'ForeName': 'Antônio', 'Initials': 'A', 'LastName': 'de Oliveira', 'Affiliation': 'Estácio University, Juazeiro do Norte, Ceará, Brazil.'}, {'ForeName': 'Clemilda', 'Initials': 'C', 'LastName': 'de Lucena', 'Affiliation': 'Estácio University, Juazeiro do Norte, Ceará, Brazil.'}, {'ForeName': 'Johnnatas', 'Initials': 'J', 'LastName': 'Lopes', 'Affiliation': 'Federal University Vale of São Francisco, Pernanbuco, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Pegado', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte Brazil.'}]",Journal of diabetes and metabolic disorders,['10.1007/s40200-020-00513-4']
2697,32550229,"Effect of Health-Promoting Lifestyle Modification Education on Knowledge, Attitude, and Quality of Life of Postmenopausal Women.","Limited knowledge and negative attitudes about menopause among postmenopausal women (PMW) create a multitude of health-related issues leading to impaired quality of life (QOL) among them. This study evaluated the impact of a health-promoting lifestyle education intervention (HPLEI) on knowledge, attitude, and QOL in a group of PMW in Sri Lanka. A quasi-experimental study was conducted with 72 PMW, matched for sociodemographic status of the community from two geographically separated areas in Galle, and they were allocated to intervention ( n  = 37) and control ( n  = 35) groups. HPLEI is comprised of health education sessions focused on postmenopausal health management with lifestyle modifications provided only for the intervention group for 8 weeks and follow-up for 6 months. The control group was not given any planned education programme and was allowed to proceed with the usual lifestyle during this period. Knowledge, attitude, menopause-specific QOL (MENQOL), and overall QOL were evaluated in both groups with self-administered questionnaires at the baseline, after 8 weeks of education sessions and at the end of 6 months of follow-up. The mean (SD) ages of the intervention and control groups were 54.6 (4.5) and 56.5 (3.4) ( p  = 0.06) years, respectively. All evaluated variable scores were not different between the intervention and control groups ( p  > 0.05) at the baseline. In the intervention group, knowledge (mean ± SD; 21.70 ± 1.05) and attitude (mean ± SD; 44.02 ± 5.33) scores increased at the end ( p  < 0.001). In the control group, a marginal increase in all dimensions of knowledge scores (mean ± SD; 9.71 ± 2.21) and unchanged attitude scores (mean ± SD; 23.91 ± 7.56) were seen. All MENQOL scores decreased during the follow-up in the intervention group (mean ± SD; 138.51 ± 18.47) ( p  < 0.001) except the sexual domain ( p  = 0.32). MENQOL scores were increased in the control group (mean ± SD; 92.05 ± 28.87) ( p  < 0.001) with time. Overall QOL scores increased (mean ± SD; 74.85 ± 9.71) ( p  < 0.001) in the intervention group during the study period and in the control group overall QOL (mean ± SD; 51.03 ± 13.61) showed a reduction ( p  < 0.001) at the end. Health education focused on health-promoting lifestyle modifications was effective in improving knowledge, attitude, MENQOL, and overall QOL of PMW.",2020,Overall QOL scores increased (mean ± SD; 74.85 ± 9.71) ( p  < 0.001) in the intervention group during the study period and in the control group overall QOL (mean ± SD; 51.03 ± 13.61) showed a reduction ( p  < 0.001) at the end.,"['Postmenopausal Women', 'postmenopausal women (PMW', '72 PMW, matched for sociodemographic status of the community from two geographically separated areas in Galle, and they were allocated to intervention ( n  = 37) and control ( n  = 35) groups']","['health-promoting lifestyle education intervention (HPLEI', 'Health-Promoting Lifestyle Modification Education', 'planned education programme']","['All MENQOL scores', 'Overall QOL scores', 'knowledge, attitude, MENQOL, and overall QOL of PMW', 'MENQOL scores', 'unchanged attitude scores', 'knowledge scores', 'Knowledge, attitude, menopause-specific QOL (MENQOL), and overall QOL', 'Knowledge, Attitude, and Quality of Life', 'knowledge, attitude, and QOL']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0442739', 'cui_str': 'No status change'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",,0.0284563,Overall QOL scores increased (mean ± SD; 74.85 ± 9.71) ( p  < 0.001) in the intervention group during the study period and in the control group overall QOL (mean ± SD; 51.03 ± 13.61) showed a reduction ( p  < 0.001) at the end.,"[{'ForeName': 'Nirmala', 'Initials': 'N', 'LastName': 'Rathnayake', 'Affiliation': 'Department of Nursing, Faculty of Allied Health Sciences, University of Ruhuna, Sri Lanka.'}, {'ForeName': 'Gayani', 'Initials': 'G', 'LastName': 'Alwis', 'Affiliation': 'Department of Anatomy, Faculty of Medicine, University of Ruhuna, Sri Lanka.'}, {'ForeName': 'Janaka', 'Initials': 'J', 'LastName': 'Lenora', 'Affiliation': 'Department of Physiology, Faculty of Medicine, University of Ruhuna, Sri Lanka.'}, {'ForeName': 'Iresha', 'Initials': 'I', 'LastName': 'Mampitiya', 'Affiliation': 'Department of Gynecology and Obstetrics, Faculty of Medicine, University of Ruhuna, Sri Lanka.'}, {'ForeName': 'Sarath', 'Initials': 'S', 'LastName': 'Lekamwasam', 'Affiliation': 'Population Health Research Centre, Department of Medicine, Faculty of Medicine, University of Ruhuna, Sri Lanka.'}]",BioMed research international,['10.1155/2020/3572903']
2698,32550239,Retention in Care and Viral Load Improvement After Discharge Among Hospitalized Out-of-Care People With HIV Infection: A Post Hoc Analysis of a Randomized Controlled Trial.,"Background


Understanding factors influencing retention in care (RIC) and viral load improvement (VLI) in people with HIV (PWH) who are out of care and hospitalized will assist in intervention development for this vulnerable population.
Methods


The study was a post hoc analysis of prospectively collected data. Hospitalized participants were enrolled if they were newly diagnosed with HIV during the hospitalization or out of HIV care. Participants completed surveys at baseline and 6 months postenrollment and laboratory studies of viral load (VL). Outcomes were RIC (2 completed visits, 1 within 30 days of discharge) and VLI (VL <400 or at least a 1-log 10  decrease) 6 months after discharge. Univariate and multivariate regression analyses were conducted examining the contributions of predisposing, enabling, and need factors to outcomes.
Results


The study cohort included 417 participants enrolled between 2010 and 2013. The population was 73% male, 67% non-Hispanic black, 19% Hispanic, and 70% uninsured. Sixty-five percent had a baseline CD4 <200 cells/mm 3 , 79% had a VL >400 copies/mL or missing, and the population was generally poor with low educational attainment. After discharge from the hospital, 60% did not meet the definition for RIC, and 49% did not have VLI. Modifiable factors associated with the outcomes include drug use (including marijuana alone and other drugs), life instability (eg, housing, employment, and life chaos), and using avoidance coping strategies in coping with HIV.
Conclusions


Hospitalized out-of-care PWH in the United States are at high risk of poor re-engagement in care after discharge. Interventions for this population should focus on improving socioeconomic stability and coping with HIV and reducing drug use.",2020,"Modifiable factors associated with the outcomes include drug use (including marijuana alone and other drugs), life instability (eg, housing, employment, and life chaos), and using avoidance coping strategies in coping with HIV.
","['Hospitalized participants were enrolled if they were newly diagnosed with HIV during the hospitalization or out of HIV care', 'Hospitalized Out-of-Care People With HIV Infection', '417 participants enrolled between 2010 and 2013', 'The population was 73% male, 67% non-Hispanic black, 19% Hispanic, and 70% uninsured', 'people with HIV (PWH']",[],"['drug use (including marijuana alone and other drugs), life instability (eg, housing, employment, and life chaos), and using avoidance coping strategies in coping with HIV', 'Retention in Care and Viral Load Improvement']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C5191297', 'cui_str': '417'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0087134', 'cui_str': 'Uninsured'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",[],"[{'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C1194380', 'cui_str': 'Chaos'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C4704685', 'cui_str': 'Care Retention'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}]",417.0,0.438079,"Modifiable factors associated with the outcomes include drug use (including marijuana alone and other drugs), life instability (eg, housing, employment, and life chaos), and using avoidance coping strategies in coping with HIV.
","[{'ForeName': 'Kellee', 'Initials': 'K', 'LastName': 'English', 'Affiliation': 'School of Health Professions, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'May', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Davila', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Cully', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Dindo', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'K Rivet', 'Initials': 'KR', 'LastName': 'Amico', 'Affiliation': 'Applied Health Research, Brighton, Michigan, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Kallen', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Giordano', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, Texas, USA.'}]",Open forum infectious diseases,['10.1093/ofid/ofaa193']
2699,32550299,Ultrasound-guided lateral versus posterior Quadratus Lumborum Block for postoperative pain after laparoscopic cholecystectomy: a randomized controlled trial.,"Objectives


The aim of the present study was to investigate the effect of ultrasound-guided bilateral posterior quadratus lumborum block (QLB) and lateral QLB on postoperative pain scores after laparoscopic cholecystectomy.
Material and Methods


In this prospective, randomized, single-blind study; 60 patients with elective laparoscopic cholecystectomy operations were randomized into two groups as group P (n= 30): Posterior Quadratus Lumborum Block + IV patient-controlled analgesia (PCA) tramadol and group L (n= 30): Lateral Quadratus Lumborum Block + IV PCA tramadol. Primary outcome measures included the amount of total consumption (24 hours) of tramadol. Secondary outcome measures; Visual Analog Scala (VAS) scores at rest and on movement (postoperative 30th minute, 2nd, 6th, 12th, and 24th hours) were recorded. Adverse effects (nausea and vomiting), additional analgesic requirement, and intraoperative opioid requirement were recorded.
Results


Postoperative total consumption amounts of tramadol and VAS scores (rest and on movement) were compared, and there was no statistically significant difference between the two groups (p> 0.05). There was no statistically significant difference in adverse effects (nausea and vomiting), additional analgesic requirement, and intraoperative opioid requirement between the two groups (p> 0.05).
Conclusion


Similar postoperative tramadol consumption values and VAS scores were determined in both lateral QLB and posterior QLB block applications in the results of our study.",2019,"There was no statistically significant difference in adverse effects (nausea and vomiting), additional analgesic requirement, and intraoperative opioid requirement between the two groups (p> 0.05).
","['60 patients with elective laparoscopic cholecystectomy operations', 'n= 30', 'postoperative pain after laparoscopic cholecystectomy']","['Ultrasound-guided lateral versus posterior Quadratus Lumborum Block', 'Posterior Quadratus Lumborum Block + IV patient-controlled analgesia (PCA) tramadol and group L ', 'ultrasound-guided bilateral posterior quadratus lumborum block (QLB) and lateral QLB', 'Lateral Quadratus Lumborum Block + IV PCA tramadol']","['postoperative pain scores', 'postoperative tramadol consumption values and VAS scores', 'Adverse effects (nausea and vomiting), additional analgesic requirement, and intraoperative opioid requirement', 'Visual Analog Scala (VAS) scores at rest and on movement (postoperative 30th minute, 2nd, 6th, 12th, and 24th hours', 'amount of total consumption (24 hours) of tramadol', 'Postoperative total consumption amounts of tramadol and VAS scores (rest and on movement', 'adverse effects (nausea and vomiting), additional analgesic requirement, and intraoperative opioid requirement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0441846', 'cui_str': 'Group L'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]",60.0,0.144181,"There was no statistically significant difference in adverse effects (nausea and vomiting), additional analgesic requirement, and intraoperative opioid requirement between the two groups (p> 0.05).
","[{'ForeName': 'Korgün', 'Initials': 'K', 'LastName': 'Ökmen', 'Affiliation': 'Sağlık Bilimleri Üniversitesi, Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi, Anestezi ve Reanimasyon Kliniği, Bursa, Türkiye.'}, {'ForeName': 'Burcu', 'Initials': 'B', 'LastName': 'Metin Ökmen', 'Affiliation': 'Sağlık Bilimleri Üniversitesi, Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi, Fizik Tedavi ve Rehabilitasyon Kliniği, Bursa, Türkiye.'}, {'ForeName': 'Erkan', 'Initials': 'E', 'LastName': 'Sayan', 'Affiliation': 'Sağlık Bilimleri Üniversitesi, Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi, Anestezi ve Reanimasyon Kliniği, Bursa, Türkiye.'}]",Turkish journal of surgery,['10.5578/turkjsurg.4161']
2700,32550301,Comparison of minimally invasive preperitoneal (MIP) single-layer mesh repair and total extraperitoneal (TEP) repair for inguinal hernia in terms of postoperative chronic pain: a prospective randomized trial.,"Objectives


The aim of this study was to compare minimally invasive preperitoneal (MIP) single layer mesh repair with total extraperitoneal (TEP) inguinal hernia repair in terms of complications, recurrence, and chronic pain.
Material and Methods


A total of 240 patients who underwent elective, primary, unilateral inguinal hernia operation between April 2011 and September 2012 were divided into two randomized groups. The first group underwent MIP repair and the second group underwent TEP repair. Visual Analogue Scale (VAS) and Sheffield Scale (SS) were used to evaluate chronic pain.
Results


In all, 225 (95%) of the patients completed follow-up and were included in analyses. A significant difference was not detected between groups in terms of demographics, operative time, or intraoperative, early, or late complications. Length of time before return to work was significantly shorter in the TEP group (p <0.001). Recurrence was seen in 1 (0.88%) patient in the MIP group and 1 (0.89%) patient in the TEP group (p= 0.993). Evaluation of chronic pain revealed no significant difference between groups in VAS and SS values at postoperative 6th, 12th, and 24th months.
Conclusion


In conclusion, it was observed that MIP repair for inguinal hernia has all of the advantages of preperitoneal repair and eliminates disadvantages of TEP repair. MIP technique is as safe as TEP repair and has similar qualities in terms of chronic pain, even though it is an open intervention.",2019,Length of time before return to work was significantly shorter in the TEP group (p <0.001).,"['240 patients who underwent elective, primary, unilateral inguinal hernia operation between April 2011 and September 2012']","['MIP repair and the second group underwent TEP repair', 'MIP technique', 'TEP) repair for inguinal hernia', 'TEP', 'minimally invasive preperitoneal (MIP) single layer mesh repair with total extraperitoneal (TEP) inguinal hernia repair', 'minimally invasive preperitoneal (MIP) single-layer mesh repair and total extraperitoneal']","['Length of time before return to work', 'postoperative chronic pain', 'complications, recurrence, and chronic pain', 'Recurrence', 'chronic pain', 'Visual Analogue Scale (VAS) and Sheffield Scale (SS', 'demographics, operative time, or intraoperative, early, or late complications', 'VAS and SS values']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0442170', 'cui_str': 'Preperitoneal approach'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0442090', 'cui_str': 'Extraperitoneal'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",240.0,0.122671,Length of time before return to work was significantly shorter in the TEP group (p <0.001).,"[{'ForeName': 'Nergis', 'Initials': 'N', 'LastName': 'Aksoy', 'Affiliation': 'Konya Eğitim ve Araştırma Hastanesi, Genel Cerrahi Kliniği, Konya, Türkiye.'}, {'ForeName': 'Kemal', 'Initials': 'K', 'LastName': 'Arslan', 'Affiliation': 'Konya Eğitim ve Araştırma Hastanesi, Genel Cerrahi Kliniği, Konya, Türkiye.'}, {'ForeName': 'Osman', 'Initials': 'O', 'LastName': 'Doğru', 'Affiliation': 'Konya Eğitim ve Araştırma Hastanesi, Genel Cerrahi Kliniği, Konya, Türkiye.'}, {'ForeName': 'Ömer', 'Initials': 'Ö', 'LastName': 'Karahan', 'Affiliation': 'Uşak Üniversitesi Tıp Fakültesi, Genel Cerrahi Anabilim Dalı, Uşak, Türkiye.'}, {'ForeName': 'Mehmet Ali', 'Initials': 'MA', 'LastName': 'Eryılmaz', 'Affiliation': 'Konya Eğitim ve Araştırma Hastanesi, Genel Cerrahi Kliniği, Konya, Türkiye.'}]",Turkish journal of surgery,['10.5578/turkjsurg.4128']
2701,32553024,Exercise Intervention Outcomes with Cannabis Users and Nonusers Aged 60 and Older.,"Objectives:  Cannabis use is increasing among older adults. We examined whether cannabis use impacted results of an intervention to increase physical activity in sedentary adults aged 60 and over.  Methods:  We measured differences in body mass index (BMI), exercise behavior, and cardiovascular fitness between older adult cannabis users (N = 28) and nonusers (N = 136) participating in an exercise intervention trial.  Results:  BMI of cannabis users was significantly lower than non-users (p = .007). Cannabis users reported .70 more days of exercise on the Stanford 7-Day Physical Activity Recall than non-users at the 8-week timepoint (p = .068) and were 4.1 points higher on the exercise subscale of the Community Healthy Activities Model Program for Seniors at 16-weeks (p = .045). Neither baseline nor post-intervention fitness differed by cannabis use status, and cardiovascular fitness improved after intervention in the full sample.  Conclusion:  These preliminary data suggest that current cannabis use status is not associated with a negative impact on fitness and efforts to increase exercise in sedentary older adults. Future studies should collect more detailed information on patterns and forms of cannabis use to understand their potential health effects for older adults.",2020,"Neither baseline nor post-intervention fitness differed by cannabis use status, and cardiovascular fitness improved after intervention in the full sample.  ","['older adult cannabis users (N = 28) and nonusers (N = 136) participating in an exercise intervention trial', 'older adults', 'Aged 60 and Older', 'sedentary adults aged 60 and over', 'sedentary older adults', 'Cannabis Users and Nonusers']",[],"['body mass index (BMI), exercise behavior, and cardiovascular fitness', 'physical activity', 'BMI of cannabis users', 'cannabis use status, and cardiovascular fitness', 'Stanford 7-Day Physical Activity Recall']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]",136.0,0.0641099,"Neither baseline nor post-intervention fitness differed by cannabis use status, and cardiovascular fitness improved after intervention in the full sample.  ","[{'ForeName': 'Sophie L', 'Initials': 'SL', 'LastName': 'YorkWilliams', 'Affiliation': 'Sophie L. YorkWilliams, Department of Psychology & Neuroscience, University of Colorado Boulder, Boulder, CO;, Email: sophie.yorkwilliams@colorado.edu.'}, {'ForeName': 'Laurel P', 'Initials': 'LP', 'LastName': 'Gibson', 'Affiliation': 'Laurel P. Gibson, Department of Psychology & Neuroscience, University of Colorado Boulder, Boulder, CO.'}, {'ForeName': 'Charleen J', 'Initials': 'CJ', 'LastName': 'Gust', 'Affiliation': 'Charleen J. Gust, Department of Psychology & Neuroscience, University of Colorado Boulder, Boulder, CO.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Giordano', 'Affiliation': 'Gregory Giordano, Department of Psychology & Neuroscience, University of Colorado Boulder, Boulder, CO.'}, {'ForeName': 'Kent E', 'Initials': 'KE', 'LastName': 'Hutchison', 'Affiliation': 'Kent E. Hutchison, Department of Psychology & Neuroscience , University of Colorado Boulder, Boulder, CO.'}, {'ForeName': 'Angela D', 'Initials': 'AD', 'LastName': 'Bryan', 'Affiliation': 'Angela D. Bryan, Department of Psychology & Neuroscience, University of Colorado Boulder, Boulder, CO.'}]",American journal of health behavior,['10.5993/AJHB.44.4.5']
2702,32553077,Hyperbaric Oxygen Treatment Improves Hearing Level  via  Attenuating TLR4/NF-κB Mediated Inflammation in Sudden Sensorineural Hearing Loss Patients.,"Objective


Hyperbaric oxygen treatment (HBOT) has demonstrated efficacy in improving hearing levels of patients with idiopathic sudden sensorineural hearing loss (ISSHL); however, the underlying mechanisms are not well understood. HBOT alleviates the inflammatory response, which is mediated by Toll-like receptor (TLR) 4 and nuclear factor (NF)-κB. In this study we investigated whether HBOT attenuates inflammation in ISHHL patients  via  alteration of TLR4 and NF-κB expression.
Methods


ISHHL patients (  n  = 120) and healthy control subjects (  n  = 20) were enrolled in this study. Patients were randomly divided into medicine group treated with medicine only (  n  = 60) and HBO group receiving both HBOT and medicine (  n  = 60). Audiometric testing was performed pre- and post-treatment. TLR4, NF-кB, and TNF-α expression in peripheral blood of ISSHL patients and healthy control subjects was assessed by ELISA before and after treatment.
Results


TLR4, NF-κB, and TNF-α levels were upregulated in ISSHL patients relative to healthy control subjects; the levels were decreased following treatment and were lower in the HBO group than that in the medicine group post-treatment (  P  < 0.05 and  P  < 0.01).
Conclusion


HBOT alleviates hearing loss in ISSHL patients by suppressing the inflammatory response induced by TLR4 and NF-κB signaling.",2020,"TLR4, NF-κB, and TNF-α levels were upregulated in ISSHL patients relative to healthy control subjects; the levels were decreased following treatment and were lower in the HBO group than that in the medicine group post-treatment (  P  < 0.05 and  P  < 0.01).
","['Methods\n\n\nISHHL patients (  n  = 120) and healthy control subjects (  n  = 20', 'patients with idiopathic sudden sensorineural hearing loss (ISSHL', 'Sudden Sensorineural Hearing Loss Patients', 'ISHHL patients  via  alteration of TLR4 and NF-κB expression']","['Hyperbaric oxygen treatment (HBOT', 'HBOT', 'medicine group treated with medicine only (  n  = 60) and HBO group receiving both HBOT and medicine', 'Hyperbaric Oxygen Treatment']","['TLR4, NF-κB, and TNF-α levels', 'TLR4, NF-кB, and TNF-α expression in peripheral blood']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C4275242', 'cui_str': 'Sudden sensorineural hearing loss'}, {'cui': 'C1321919', 'cui_str': 'TLR4 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C1321919', 'cui_str': 'TLR4 protein, human'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}]",20.0,0.019627,"TLR4, NF-κB, and TNF-α levels were upregulated in ISSHL patients relative to healthy control subjects; the levels were decreased following treatment and were lower in the HBO group than that in the medicine group post-treatment (  P  < 0.05 and  P  < 0.01).
","[{'ForeName': 'Xue Hua', 'Initials': 'XH', 'LastName': 'Liu', 'Affiliation': 'Department of Hyperbaric Oxygen Medicine, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Liang', 'Affiliation': 'Department of Hyperbaric Oxygen Medicine, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, China.'}, {'ForeName': 'Xing Yuan', 'Initials': 'XY', 'LastName': 'Jia', 'Affiliation': 'Institute of Basic Medicine Sciences, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Department of Hyperbaric Oxygen Medicine, Beijing Pinggu Hospital, Beijing 101200, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Institute of Basic Medicine Sciences, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Hyperbaric Oxygen Medicine, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, China.'}]",Biomedical and environmental sciences : BES,['10.3967/bes2020.045']
2703,32553103,Comparison of blood loss between intra-articular and intra-venous administration of tranexamic acid in primary total knee arthroplasty.,"OBJECTIVE


To compare the blood loss between intra-articular and intra-venous administration of tranexamic acid (TXA) in patients undergoing primary total knee arthroplasty.
DESIGN OF STUDY


It was a randomized controlled trial. Study duration and settings: This study was carried out at the Orthopedic Departments of Combined Military Hospital Lahore and Rawalpindi from Jan 2016 to March 2018.
METHODOLOGY


Patients of both the genders were involved this study who had age in the rage of 40-80 years undergoing primary unilateral total knee arthroplasty for degenerative conditions like osteoarthritis and rheumatoid arthritis. These patients were randomly divided into two treatment groups. Patients in IA group received intra-articular tranexamic acid while those in IV group received intravenous tranexamic acid. From all the patients, a written signed consent was taken.
FINDINGS


Females were predominant with male-to-female ratio of 1:3.7. The mean age of the patients was 67.3 ± 8.2 years while the mean BMI was 30.9 ± 2.9 Kg/m 2 . Majority (n = 191, 95.5%) of the patients had osteoarthritis while remaining 9 (4.5%) patients had rheumatoid arthritis. There was no statistically significant difference between intra-articular and intra-venous administration of tranexamic acid in terms of mean post-operative hemoglobin (9.93 ± 1.14 vs. 9.87 ± 1.26 g/dL; p-value = 0.724), mean post-operative hematocrit (34.8 ± 1.66 vs. 34.73 ± 1.27%; p-value = 0.594), and mean fall in hemoglobin (2.27 ± 0.34 vs. 2.25 ± 0.30 g/dL; p-value = 0.587) and hematocrit (2.34 ± 0.94 vs. 2.46 ± 0.28%; p-value = 0.216).
CONCLUSION


Intra-articular administration of tranexamic acid was found to be as effective and safe as intra-venous administration in reducing blood loss in primary total knee arthroplasty. Due to convenience, the use of intra-articular administration of tranexamic acid after primary TKA may be considered in future practice.",2020,There was no statistically significant difference between intra-articular and intra-venous administration of tranexamic acid in terms of mean post-operative hemoglobin (9.93 ± ,"['Majority (n\xa0', 'Females were predominant with male-to-female ratio of 1:3.7', 'primary total knee arthroplasty', 'patients undergoing primary total knee arthroplasty', 'The mean age of the patients was 67.3\xa0±\xa08.2\xa0years while the mean BMI was 30.9\xa0±', 'Patients of both the genders were involved this study who had age in the rage of 40-80\xa0years undergoing primary unilateral total knee arthroplasty for degenerative conditions like osteoarthritis and rheumatoid arthritis', 'Orthopedic Departments of Combined Military Hospital Lahore and Rawalpindi from Jan 2016 to March 2018']","['tranexamic acid (TXA', 'tranexamic acid', 'intra-articular tranexamic acid']","['mean post-operative hematocrit', 'hematocrit', 'mean fall in hemoglobin', 'osteoarthritis', 'rheumatoid arthritis', 'blood loss']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0034634', 'cui_str': 'Rage'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0587525', 'cui_str': 'Orthopedic department'}, {'cui': 'C0020012', 'cui_str': 'Military Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",,0.0795964,There was no statistically significant difference between intra-articular and intra-venous administration of tranexamic acid in terms of mean post-operative hemoglobin (9.93 ± ,"[{'ForeName': 'Muhammad Suhail', 'Initials': 'MS', 'LastName': 'Amin', 'Affiliation': 'Professor Orthopedic, CMH Hospital Rawalpindi and CMH Lahore Orthopedic ward, CMH Hospital Rawalpindi, Pakistan.'}, {'ForeName': 'Muhammad Khurram', 'Initials': 'MK', 'LastName': 'Habib', 'Affiliation': 'Assistant Professor Orthopedics, DHQ Hospital Faisalabad, Clinical Fellow, CMH Lahore, DHQ Hospital Faisalabad Orthopedics ward, Pakistan.'}, {'ForeName': 'Aziz Ur', 'Initials': 'AU', 'LastName': 'Rehman', 'Affiliation': 'Clinical fellow CMH Hospital Rawalpindi and CMH Lahore, Pakistan.'}]",SICOT-J,['10.1051/sicotj/2020017']
2704,32553118,"Berzosertib plus gemcitabine versus gemcitabine alone in platinum-resistant high-grade serous ovarian cancer: a multicentre, open-label, randomised, phase 2 trial.","BACKGROUND


High-grade serous ovarian cancers show increased replication stress, rendering cells vulnerable to ATR inhibition because of near universal loss of the G1/S checkpoint (through deleterious TP53 mutations), premature S phase entry (due to CCNE1 amplification, RB1 loss, or CDKN2A mRNA downregulation), alterations of homologous recombination repair genes, and expression of oncogenic drivers (through MYC amplification and other mechanisms). We hypothesised that the combination of the selective ATR inhibitor, berzosertib, and gemcitabine could show acceptable toxicity and superior efficacy to gemcitabine alone in high-grade serous ovarian cancer.
METHODS


In this multicentre, open-label, randomised, phase 2 study, 11 different centres in the US Experimental Therapeutics Clinical Trials Network enrolled women (aged ≥18 years) with recurrent, platinum-resistant high-grade serous ovarian cancer (determined histologically) and Eastern Cooperative Oncology Group performance status of 0 or 1, who had unlimited previous lines of cytotoxic therapy in the platinum-sensitive setting but no more than one line of cytotoxic therapy in the platinum-resistant setting. Eligible patients were randomly assigned (1:1) to receive intravenous gemcitabine (1000 mg/m 2 ) on day 1 and day 8, or gemcitabine plus intravenous berzosertib (210 mg/m 2 ) on day 2 and day 9 of a 21-day cycle until disease progression or intolerable toxicity. Randomisation was done centrally using the Theradex Interactive Web Response System, stratified by platinum-free interval, and with a permuted block size of six. Following central randomisation, patients and investigators were not masked to treatment assignment. The primary endpoint was investigator-assessed progression-free survival, and analyses included all patients who received at least one dose of the study drugs. The study is registered with ClinicalTrials.gov, NCT02595892, and is active but closed to enrolment.
FINDINGS


Between Feb 14, 2017, and Sept 7, 2018, 88 patients were assessed for eligibility, of whom 70 were randomly assigned to treatment with gemcitabine alone (36 patients) or gemcitabine plus berzosertib (34 patients). At the data cutoff date (Feb 21, 2020), the median follow-up was 53·2 weeks (25·6-81·8) in the gemcitabine plus berzosertib group and 43·0 weeks (IQR 23·2-69·1) in the gemcitabine alone group. Median progression-free survival was 22·9 weeks (17·9-72·0) for gemcitabine plus berzosertib and 14·7 weeks (90% CI 9·7-36·7) for gemcitabine alone (hazard ratio 0·57, 90% CI 0·33-0·98; one-sided log-rank test p=0·044). The most common treatment-related grade 3 or 4 adverse events were decreased neutrophil count (14 [39%] of 36 patients in the gemcitabine alone group vs 16 [47%] of 34 patients in the gemcitabine plus berzosertib group) and decreased platelet count (two [6%] vs eight [24%]). Serious adverse events were observed in ten (28%) patients in the gemcitabine alone group and nine (26%) patients in the gemcitabine plus berzosertib group. There was one treatment-related death in the gemcitabine alone group due to sepsis and one treatment-related death in the gemcitabine plus berzosertib group due to pneumonitis.
INTERPRETATION


To our knowledge, this is the first randomised study of an ATR inhibitor in any tumour type. This study shows a benefit of adding berzosertib to gemcitabine in platinum-resistant high-grade serous ovarian cancer. This combination warrants further investigation in this setting.
FUNDING


US National Cancer Institute.",2020,"Median progression-free survival was 22·9 weeks (17·9-72·0) for gemcitabine plus berzosertib and 14·7 weeks (90% CI 9·7-36·7) for gemcitabine alone (hazard ratio 0·57, 90% CI 0·33-0·98; one-sided log-rank test p=0·044).","['platinum-resistant high-grade serous ovarian cancer', '88 patients were assessed for eligibility, of whom 70', '11 different centres in the US Experimental Therapeutics Clinical Trials Network enrolled women (aged ≥18 years) with recurrent, platinum-resistant high-grade serous ovarian cancer (determined histologically) and Eastern Cooperative Oncology Group performance status of 0 or 1, who had unlimited previous lines of cytotoxic therapy in the platinum-sensitive setting but no more than one line of cytotoxic therapy in the platinum-resistant setting', 'Eligible patients', 'Between Feb 14, 2017, and Sept 7, 2018']","['Berzosertib plus gemcitabine', 'gemcitabine plus intravenous berzosertib', 'gemcitabine alone', 'intravenous gemcitabine', 'gemcitabine plus berzosertib', 'gemcitabine', 'berzosertib to gemcitabine']","['platelet count', 'Median progression-free survival', 'neutrophil count', 'death', 'investigator-assessed progression-free survival', 'Serious adverse events']","[{'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0440743', 'cui_str': 'Serous'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0233535', 'cui_str': 'Butting'}, {'cui': 'C0439093', 'cui_str': '>'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",88.0,0.0861426,"Median progression-free survival was 22·9 weeks (17·9-72·0) for gemcitabine plus berzosertib and 14·7 weeks (90% CI 9·7-36·7) for gemcitabine alone (hazard ratio 0·57, 90% CI 0·33-0·98; one-sided log-rank test p=0·044).","[{'ForeName': 'Panagiotis A', 'Initials': 'PA', 'LastName': 'Konstantinopoulos', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA. Electronic address: panagiotis_konstantinopoulos@dfci.harvard.edu.'}, {'ForeName': 'Su-Chun', 'Initials': 'SC', 'LastName': 'Cheng', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Andrea E', 'Initials': 'AE', 'LastName': 'Wahner Hendrickson', 'Affiliation': 'Department of Medical Oncology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Penson', 'Affiliation': 'Department of Medical Oncology, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Susan T', 'Initials': 'ST', 'LastName': 'Schumer', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'L Austin', 'Initials': 'LA', 'LastName': 'Doyle', 'Affiliation': 'Department of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD, USA.'}, {'ForeName': 'Elizabeth K', 'Initials': 'EK', 'LastName': 'Lee', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Elise C', 'Initials': 'EC', 'LastName': 'Kohn', 'Affiliation': 'Department of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD, USA.'}, {'ForeName': 'Linda R', 'Initials': 'LR', 'LastName': 'Duska', 'Affiliation': 'Department of Obstetrics and Gynecology, Cancer Center, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Marta A', 'Initials': 'MA', 'LastName': 'Crispens', 'Affiliation': 'Department of Obstetrics and Gynecology, Ingram Cancer Center, Vanderbilt University Nashville, TN, USA.'}, {'ForeName': 'Alexander B', 'Initials': 'AB', 'LastName': 'Olawaiye', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pittsburgh Cancer Institute, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Ira S', 'Initials': 'IS', 'LastName': 'Winer', 'Affiliation': 'Department of Obstetrics and Gynecology, Karmanos Cancer Institute, Wayne State University, Detroit, MI, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Barroilhet', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Wisconsin Hospital and Clinics, Madison, WI, USA.'}, {'ForeName': 'Siqing', 'Initials': 'S', 'LastName': 'Fu', 'Affiliation': 'Department of Investigational Cancer Therapeutics, MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'McHale', 'Affiliation': 'Department of Obstetrics and Gynecology, Moores Cancer Center, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Russell J', 'Initials': 'RJ', 'LastName': 'Schilder', 'Affiliation': 'Department of Medical Oncology, Sidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Anniina', 'Initials': 'A', 'LastName': 'Färkkilä', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Dipanjan', 'Initials': 'D', 'LastName': 'Chowdhury', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Curtis', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Roxanne S', 'Initials': 'RS', 'LastName': 'Quinn', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Bowes', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Alan D', 'Initials': 'AD', 'LastName': ""D'Andrea"", 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Geoffrey I', 'Initials': 'GI', 'LastName': 'Shapiro', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Ursula A', 'Initials': 'UA', 'LastName': 'Matulonis', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30180-7']
2705,32553279,Higher Iodine Concentration Enables Radiation Dose Reduction in Coronary CT Angiography.,"RATIONALE AND OBJECTIVES


To test whether higher iodine concentration together with higher noise level could lead to a further dose reduction in an already low dose coronary CT angiography (CCTA) protocol without comprising image quality.
MATERIALS AND METHODS


One hundred eighty patients with suspected coronary artery disease (CAD) were randomly assigned into three groups: (a) conventional dose (CD) group, 100 kV with a noise index (NI) of 25 and iohexol (350 mg I/ml); (b) low dose (LD) group, 80 kV with a NI of 25 and iohexol (350 mg I/ml); (c) further low dose (FLD) group, 80 kV with a NI of 30 and iomeprol (400 mg I/ml). The volume and injection rate of contrast medium were fixed at 60 ml and 5 ml/s. The radiation dose (volume CT dose index [CTDIvol], dose length product [DLP], and effective dose [ED]) were recorded. For image quality, both quantitative (enhancement, noise, signal-to-noise ratio [SNR], and contrast-to-noise ratio [CNR]) and qualitative indices were assessed.
RESULTS


Compared to the CD group, ED was reduced by 16% and 42% in the LD and FLD groups, respectively (p < 0.05). Qualitative analysis showed no significant difference among the 3 groups (p > 0.05), while quantitative analysis revealed significantly higher attenuation in the LD and FLD groups. Signal-to-noise ratios and CNRs of the LD and FLD groups were significantly higher except for the CNR at the left circumflex branch of the FLD group (p < 0.05).
CONCLUSION


Increasing iodine concentration and noise level may further reduce the radiation dose by 26% on top of a 16% reduction from 100 kV to 80 kV without image quality compromise.",2020,"Signal-to-noise ratios and CNRs of the LD and FLD groups were significantly higher except for the CNR at the left circumflex branch of the FLD group (p < 0.05).
",['One hundred eighty patients with suspected coronary artery disease (CAD'],"['conventional dose (CD) group, 100 kV with a noise index (NI) of 25 and iohexol', 'iohexol', 'iomeprol']","['Signal-to-noise ratios and CNRs', 'image quality, both quantitative (enhancement, noise, signal-to-noise ratio [SNR], and contrast-to-noise ratio [CNR]) and qualitative indices', 'volume and injection rate of contrast medium', 'ED', 'dose length product [DLP], and effective dose [ED']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0022005', 'cui_str': 'Iohexol'}, {'cui': 'C0063810', 'cui_str': 'iomeprol'}]","[{'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",180.0,0.036461,"Signal-to-noise ratios and CNRs of the LD and FLD groups were significantly higher except for the CNR at the left circumflex branch of the FLD group (p < 0.05).
","[{'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, Beijing Tongren Hospital, Capital Medical University, No. 1 Dongjiaomin lane, Dongcheng District, Beijing 100730, P.R. China.'}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Mi', 'Affiliation': 'Department of Radiology, Beijing Tongren Hospital, Capital Medical University, No. 1 Dongjiaomin lane, Dongcheng District, Beijing 100730, P.R. China.'}, {'ForeName': 'Xubo', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': 'Department of Cardiology, Beijing Tongren Hospital, Capital Medical University, Beijing, P.R. China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, Beijing Tongren Hospital, Capital Medical University, No. 1 Dongjiaomin lane, Dongcheng District, Beijing 100730, P.R. China.'}, {'ForeName': 'Senlin', 'Initials': 'S', 'LastName': 'Guo', 'Affiliation': 'Department of Radiology, Beijing Tongren Hospital, Capital Medical University, No. 1 Dongjiaomin lane, Dongcheng District, Beijing 100730, P.R. China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Beijing Tongren Hospital, Capital Medical University, No. 1 Dongjiaomin lane, Dongcheng District, Beijing 100730, P.R. China.'}, {'ForeName': 'Hongna', 'Initials': 'H', 'LastName': 'Suo', 'Affiliation': 'Department of Radiology, Beijing Tongren Hospital, Capital Medical University, No. 1 Dongjiaomin lane, Dongcheng District, Beijing 100730, P.R. China.'}, {'ForeName': 'Ziyi', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Beijing Tongren Hospital, Capital Medical University, No. 1 Dongjiaomin lane, Dongcheng District, Beijing 100730, P.R. China.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Jin', 'Affiliation': 'Beijing Institute of Ophthalmology, Beijing Tongren Hospital, Capital Medical University, Beijing, P.R. China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Yan', 'Affiliation': 'Department of Radiology, Beijing Tongren Hospital, Capital Medical University, No. 1 Dongjiaomin lane, Dongcheng District, Beijing 100730, P.R. China.'}, {'ForeName': 'Yantao', 'Initials': 'Y', 'LastName': 'Niu', 'Affiliation': 'Department of Radiology, Beijing Tongren Hospital, Capital Medical University, No. 1 Dongjiaomin lane, Dongcheng District, Beijing 100730, P.R. China.'}, {'ForeName': 'Junfang', 'Initials': 'J', 'LastName': 'Xian', 'Affiliation': 'Department of Radiology, Beijing Tongren Hospital, Capital Medical University, No. 1 Dongjiaomin lane, Dongcheng District, Beijing 100730, P.R. China. Electronic address: cjr.xianjunfang@vip.163.com.'}]",Academic radiology,['10.1016/j.acra.2020.05.012']
2706,32553337,Safety and Efficacy of Protamine Administration for Prevention of Bleeding Complications in Patients Undergoing TAVR.,"OBJECTIVES


The aim of this study was to evaluate whether protamine administration for heparin reversal after transcatheter aortic valve replacement (TAVR) reduces bleeding complications and affects patient outcomes.
BACKGROUND


Occurrence of major bleeding complications in patients undergoing TAVR is associated with increased morbidity and mortality.
METHODS


This study included 873 patients undergoing TAVR, of whom 677 received protamine for heparin reversal. Standard access management included the use of pre-closure devices, manual compression, and percutaneous transluminal angioplasty or implantation of a covered stent graft, if necessary. The study complied with Good Clinical Practice guidelines and was approved by the local ethics committee. Written informed consent was obtained from all patients.
RESULTS


The primary endpoint, a composite of 30-day all-cause mortality and life-threatening and major bleeding, occurred less frequently in the protamine administration group (3.2%) compared with the control group (8.7%) (p = 0.003). This was driven mainly by lower rates of life-threatening and major bleeding in the protamine group (0.1% vs. 2.6% [p < 0.001] and 1.0% vs. 4.1% [p = 0.008], respectively). Furthermore, protamine administration resulted in a significantly shorter hospital stay (11.1 ± 5.8 days vs. 12.7 ± 7.8 days; p = 0.05). In the overall cohort, stroke was observed in 1.9% and myocardial infarction in 0.2% of patients, with no significant difference between the groups (p > 0.05). Multivariate analysis revealed that only protamine administration (odds ratio: 0.24; 95% confidence interval: 0.10 to 0.58; p = 0.001) and acute kidney injury (odds ratio: 5.82; 95% confidence interval: 2.02 to 16.77; p = 0.001) were independently associated with the primary endpoint.
CONCLUSIONS


Protamine administration resulted in significantly lower rates of life-threatening and major bleeding complications compared with patients without heparin reversal. Occurrence of stroke and myocardial infarction was not increased by protamine administration.",2020,"Multivariate analysis revealed that only protamine administration (odds ratio: 0.24; 95% confidence interval: 0.10 to 0.58; p = 0.001) and acute kidney injury (odds ratio: 5.82; 95% confidence interval: 2.02 to 16.77; p = 0.001) were independently associated with the primary endpoint.
","['873 patients undergoing TAVR, of whom 677 received protamine for heparin reversal', 'patients undergoing TAVR', 'Patients Undergoing TAVR']","['Protamine Administration', 'transcatheter aortic valve replacement (TAVR', 'percutaneous transluminal angioplasty or implantation of a covered stent graft', 'protamine']","['rates of life-threatening and major bleeding', 'Safety and Efficacy', 'Occurrence of stroke and myocardial infarction', 'bleeding complications', 'composite of 30-day all-cause mortality and life-threatening and major bleeding', 'acute kidney injury', 'shorter hospital stay', 'myocardial infarction', 'rates of life-threatening and major bleeding complications', 'morbidity and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0033603', 'cui_str': 'Protamines'}, {'cui': 'C0019134', 'cui_str': 'heparin'}]","[{'cui': 'C0033603', 'cui_str': 'Protamines'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C2936666', 'cui_str': 'Percutaneous transluminal angioplasty'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}]","[{'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",873.0,0.261933,"Multivariate analysis revealed that only protamine administration (odds ratio: 0.24; 95% confidence interval: 0.10 to 0.58; p = 0.001) and acute kidney injury (odds ratio: 5.82; 95% confidence interval: 2.02 to 16.77; p = 0.001) were independently associated with the primary endpoint.
","[{'ForeName': 'Baravan', 'Initials': 'B', 'LastName': 'Al-Kassou', 'Affiliation': 'Heart Center, Department of Medicine II, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Kandt', 'Affiliation': 'Heart Center, Department of Medicine II, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Lohde', 'Affiliation': 'Heart Center, Department of Medicine II, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Shamekhi', 'Affiliation': 'Heart Center, Department of Medicine II, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Sedaghat', 'Affiliation': 'Heart Center, Department of Medicine II, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Noriaki', 'Initials': 'N', 'LastName': 'Tabata', 'Affiliation': 'Heart Center, Department of Medicine II, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Weber', 'Affiliation': 'Heart Center, Department of Medicine II, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Sugiura', 'Affiliation': 'Heart Center, Department of Medicine II, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Fimmers', 'Affiliation': 'Department of Medical Biometry, Informatics, and Epidemiology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Nikos', 'Initials': 'N', 'LastName': 'Werner', 'Affiliation': 'Heart Center, Department of Medicine II, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Eberhard', 'Initials': 'E', 'LastName': 'Grube', 'Affiliation': 'Heart Center, Department of Medicine II, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Treede', 'Affiliation': 'Heart Center, Department of Cardiac Surgery, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Nickenig', 'Affiliation': 'Heart Center, Department of Medicine II, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Jan-Malte', 'Initials': 'JM', 'LastName': 'Sinning', 'Affiliation': 'Heart Center, Department of Medicine II, University Hospital Bonn, Bonn, Germany. Electronic address: jan-malte.sinning@ukbonn.de.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.03.041']
2707,32553394,ECT non-remitters: prognosis and treatment after 12 unilateral electroconvulsive therapy sessions for major depression.,"BACKGROUND


Depressive disorder causes significant suffering in patients and caregivers worldwide. Electroconvulsive therapy (ECT) is a highly effective antidepressant treatment, but little is known about the prognosis and treatment of patients who do not achieve remission with ECT. We investigated prognosis and treatment of patients with major depression who did not achieve remission after 12 unilateral electroconvulsive therapy sessions.
METHODS


We conducted a retrospective, naturalistic follow-up study. Patients who had previously participated in a double-blind randomized controlled trial that compared brief pulse with ultra-brief pulse ECT and who had not achieved remission after 12 right unilateral (RUL) ECT sessions were selected for this study. We analysed the type of treatments received during the 6-month follow-up and studied the occurrence of remission and response. The primary outcome was remission, defined as a Montgomery-Åsberg Depression Rating Scale score <10.
RESULTS


Eighty-one patients were randomized, of which 18 patients did not remit. Eight of these non-remitters achieved remission during follow-up (44.4%) while 7 did not achieve remission (38.9%). Remission data could not be retrieved for 3 patients (16.7%). Remission was achieved in 6 patients by a combination of continuing unilateral ECT with antidepressants or switching to bilateral ECT.
LIMITATIONS


This is a retrospective study with only a small number of patients. Treatment after RUL ECT non-remission was not standardized.
CONCLUSION


When patients with major depression do not achieve remission after 12 RUL ECT sessions, they have still a reasonable chance of remission within 6 months. Continuing ECT has the best chance of success.",2020,"We investigated prognosis and treatment of patients with major depression who did not achieve remission after 12 unilateral electroconvulsive therapy sessions.
","['Patients who had previously participated', 'Eighty-one patients were randomized, of which 18 patients did not remit', 'patients with major depression', 'patients who do not achieve remission with ECT', 'patients with major depression who did not achieve remission after 12 unilateral electroconvulsive therapy sessions']","['unilateral electroconvulsive therapy sessions', 'ECT', 'RUL ECT', 'Electroconvulsive therapy (ECT', 'brief pulse with ultra-brief pulse ECT and who had not achieved remission after 12 right unilateral (RUL) ECT sessions']","['remission', 'remission, defined as a Montgomery-Åsberg Depression Rating Scale score <10', 'Remission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0562344', 'cui_str': 'Unilateral electroconvulsive therapy'}]","[{'cui': 'C0562344', 'cui_str': 'Unilateral electroconvulsive therapy'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0444804', 'cui_str': 'Brief pulse'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",81.0,0.162101,"We investigated prognosis and treatment of patients with major depression who did not achieve remission after 12 unilateral electroconvulsive therapy sessions.
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'van Duist', 'Affiliation': 'Parnassia Psychiatric Institute, The Hague, The Netherlands.'}, {'ForeName': 'H P', 'Initials': 'HP', 'LastName': 'Spaans', 'Affiliation': 'Parnassia Psychiatric Institute, The Hague, The Netherlands.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Verwijk', 'Affiliation': 'Parnassia Psychiatric Institute, The Hague, The Netherlands; Department of Psychology, University of Amsterdam, Amsterdam, The Netherlands; Department of Medical Psychology, Amsterdam Unversity Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Kok', 'Affiliation': 'Parnassia Psychiatric Institute, The Hague, The Netherlands. Electronic address: r.kok@parnassia.nl.'}]",Journal of affective disorders,['10.1016/j.jad.2020.03.134']
2708,32553411,Usefulness of the alpha maneuver in the peritoneal catheter displacement: review and experience.,"INTRODUCTION AND OBJECTIVES


Peritoneal catheter displacement is one of the most common complications of peritoneal dialysis. The alpha manoeuvre has been proposed as a repositioning technique, which involves returning the catheter to its correct position using rigid guidewires under fluoroscopic guidance. The aim of this study is to analyse the 107 procedures performed at our Centre to identify factors that may predict the success of the technique.
MATERIAL AND METHODS


The alpha manoeuvre method was used in 86 patients, with a total of 107 procedures (70 patients underwent one manoeuvre only, 16 patients underwent two or more manoeuvres).
RESULTS


The overall success rate of the technique was 60%. There were no differences in success rate in terms of gender (60% male vs. 40% female, p = 0.104), time of catheter failure (early 60% vs. late 62%, p = 0.849), type of catheter (75% self-locating vs. 58% spiral, p = 0.633) or the initial position of the catheter. There was only one case of peritonitis related to the procedure.
CONCLUSIONS


The alpha manoeuvre is an effective and safe method for correcting peritoneal catheter displacement.",2020,"There were no differences in success rate in terms of gender (60% male vs. 40% female, p = 0.104), time of catheter failure (early 60% vs. late 62%, p = 0.849), type of catheter (75% self-locating vs. 58% spiral, p = 0.633) or the initial position of the catheter.","['86 patients, with a total of 107 procedures (70 patients underwent one manoeuvre only, 16 patients underwent two or more manoeuvres']",[],"['time of catheter failure', 'success rate', 'overall success rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",[],"[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",16.0,0.0223798,"There were no differences in success rate in terms of gender (60% male vs. 40% female, p = 0.104), time of catheter failure (early 60% vs. late 62%, p = 0.849), type of catheter (75% self-locating vs. 58% spiral, p = 0.633) or the initial position of the catheter.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Del Río García', 'Affiliation': 'Hospital San Agustín, Avilés, España. Electronic address: lauri_rio@hotmail.com.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Merino Bueno', 'Affiliation': 'Hospital de Cabueñes, Gijón, España.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Alcuria Ledo', 'Affiliation': 'Hospital San Agustín, Avilés, España.'}, {'ForeName': 'Lucía', 'Initials': 'L', 'LastName': 'Álvarez Santamarta', 'Affiliation': 'Hospital Universitario Central de Asturias, Oviedo, España.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Rodríguez Suárez', 'Affiliation': 'Hospital Universitario Central de Asturias, Oviedo, España.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Sánchez Álvarez', 'Affiliation': 'Hospital de Cabueñes, Gijón, España.'}]",Nefrologia : publicacion oficial de la Sociedad Espanola Nefrologia,['10.1016/j.nefro.2020.03.006']
2709,32553471,Tubal flushing with oil-based or water-based contrast at hysterosalpingography for infertility: long-term reproductive outcomes of a randomized trial.,"OBJECTIVE


To determine the impact of oil-based versus water-based contrast on pregnancy and live birth rates ≤5 years after hysterosalpingography (HSG) in infertile women.
DESIGN


A 5-year follow-up study of a multicenter randomized trial.
SETTING


Hospitals.
PATIENT(S)


Infertile women with an ovulatory cycle, 18-39 years of age, and having a low risk of tubal pathology.
INTERVENTION(S)


Use of oil-based versus water-based contrast during HSG.
MAIN OUTCOME MEASURE(S)


Ongoing pregnancy, live births, time to ongoing pregnancy, second ongoing pregnancy.
RESULT(S)


A total of 1,119 women were randomly assigned to HSG with oil-based contrast (n = 557) or water-based contrast (n = 562). After 5 years, 444 of 555 women in the oil group (80.0%) and 419 of 559 women in the water group (75.0%) had an ongoing pregnancy (relative risk [RR] 1.07; 95% confidence interval [CI] 1.00-1.14), and 415 of 555 women in the oil group (74.8%) and 376 of 559 women in the water group (67.3%) had live births (RR 1.11; 95% CI 1.03-1.20). In the oil group, 228 pregnancies (41.1%) were conceived naturally versus 194 (34.7%) pregnancies in the water group (RR 1.18; 95% CI 1.02-1.38). The time to ongoing pregnancy was significantly shorter in the oil group versus the water group (10.0 vs. 13.7 months; hazard ratio, 1.25; 95% CI 1.09-1.43). No difference was found in the occurrence of a second ongoing pregnancy.
CONCLUSION(S)


During a 5-year time frame, ongoing pregnancy and live birth rates are higher after tubal flushing with oil-based contrast during HSG compared with water-based contrast. More pregnancies are naturally conceived and time to ongoing pregnancy is shorter after HSG with oil-based contrast.
CLINICAL TRIAL REGISTRATION NUMBER


Netherlands Trial Register (NTR) 3270 and NTR6577(www.trialregister.nl).",2020,"The time to ongoing pregnancy was significantly shorter in the oil group versus the water group (10.0 vs. 13.7 months; hazard ratio, 1.25; 95% CI 1.09-1.43).","['infertile women', 'A total of 1,119 women', '\n\n\nInfertile women with an ovulatory cycle, 18-39 years of age, and having a low risk of tubal pathology', 'Hospitals']","['hysterosalpingography (HSG', 'Tubal flushing with oil-based or water-based contrast at hysterosalpingography', 'oil-based versus water-based contrast during HSG', 'oil-based versus water-based contrast', 'HSG with oil-based contrast (n = 557) or water-based contrast']","['time to ongoing pregnancy', 'ongoing pregnancy', 'occurrence of a second ongoing pregnancy', 'live births', '5-year time frame, ongoing pregnancy and live birth rates']","[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}, {'cui': 'C4285925', 'cui_str': 'Tubal flushing'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332168', 'cui_str': 'Time frame'}]",1119.0,0.17144,"The time to ongoing pregnancy was significantly shorter in the oil group versus the water group (10.0 vs. 13.7 months; hazard ratio, 1.25; 95% CI 1.09-1.43).","[{'ForeName': 'Joukje', 'Initials': 'J', 'LastName': 'van Rijswijk', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands. Electronic address: j.vanrijswijk@amsterdamumc.nl.'}, {'ForeName': 'Nienke', 'Initials': 'N', 'LastName': 'van Welie', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Dreyer', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Clarabelle T', 'Initials': 'CT', 'LastName': 'Pham', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, Victoria, Australia.'}, {'ForeName': 'Harold R', 'Initials': 'HR', 'LastName': 'Verhoeve', 'Affiliation': 'Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis, Amsterdam; the Netherlands.'}, {'ForeName': 'Annemieke', 'Initials': 'A', 'LastName': 'Hoek', 'Affiliation': 'Department of Reproductive Medicine and Gynaecology, University of Groningen, University Medical Centre Groningen, Hanzeplein, the Netherlands.'}, {'ForeName': 'Jan Peter', 'Initials': 'JP', 'LastName': 'de Bruin', 'Affiliation': 'Department of Obstetrics and Gynaecology, Jeroen Bosch Hospital, Hertogenbosch, the Netherlands.'}, {'ForeName': 'Annemiek W', 'Initials': 'AW', 'LastName': 'Nap', 'Affiliation': 'Department of Obstetrics and Gynaecology, Rijnstate Hospital, Arnhem, the Netherlands.'}, {'ForeName': 'Machiel H A', 'Initials': 'MHA', 'LastName': 'van Hooff', 'Affiliation': 'Department of Obstetrics and Gynaecology, Franciscus Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'Mariëtte', 'Initials': 'M', 'LastName': 'Goddijn', 'Affiliation': 'Centre for Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Angelo B', 'Initials': 'AB', 'LastName': 'Hooker', 'Affiliation': 'Department of Obstetrics and Gynaecology, Zaans Medical Centre, Zaandam, the Netherlands.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Bourdrez', 'Affiliation': 'Department of Obstetrics and Gynaecology, VieCuri Medical Centre, Venlo, the Netherlands.'}, {'ForeName': 'Angelique J C M', 'Initials': 'AJCM', 'LastName': 'van Dongen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hospital Gelderse Vallei, Ede, the Netherlands.'}, {'ForeName': 'Ilse A J', 'Initials': 'IAJ', 'LastName': 'van Rooij', 'Affiliation': 'Department of Obstetrics and Gynaecology, Elisabeth-TweeSteden Hospital, Tilburg, the Netherlands.'}, {'ForeName': 'Henrike G M', 'Initials': 'HGM', 'LastName': 'van Rijnsaardt-Lukassen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Albert Schweitzer Hospital, Dordrecht, the Netherlands.'}, {'ForeName': 'Ron J T', 'Initials': 'RJT', 'LastName': 'van Golde', 'Affiliation': 'Department of Obstetrics and Gynaecology, Maastricht UMC, Maastricht, the Netherlands.'}, {'ForeName': 'Cathelijne F', 'Initials': 'CF', 'LastName': 'van Heteren', 'Affiliation': 'Department of Obstetrics and Gynaecology, Canisius Wilhelmina Hospital, Nijmegen, the Netherlands.'}, {'ForeName': 'Marie J', 'Initials': 'MJ', 'LastName': 'Pelinck', 'Affiliation': 'Department of Obstetrics and Gynaecology, Scheper Hospital, Emmen, the Netherlands.'}, {'ForeName': 'Annette E J', 'Initials': 'AEJ', 'LastName': 'Duijn', 'Affiliation': 'Vrouwenkliniek Zuidoost, Amsterdam, the Netherlands.'}, {'ForeName': 'Mesrure', 'Initials': 'M', 'LastName': 'Kaplan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Röpcke-Zweers Hospital, Hardenberg, the Netherlands.'}, {'ForeName': 'Cornelis B', 'Initials': 'CB', 'LastName': 'Lambalk', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Velja', 'Initials': 'V', 'LastName': 'Mijatovic', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Ben W J', 'Initials': 'BWJ', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Clayton, Victoria, Australia.'}]",Fertility and sterility,['10.1016/j.fertnstert.2020.03.022']
2710,32553489,"High Prevalence of Multidrug-Resistant Organism Colonization in 28 Nursing Homes: An ""Iceberg Effect"".","OBJECTIVE


Determine the prevalence of methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus spp. (VRE), extended-spectrum beta-lactamase producing organisms (ESBLs), and carbapenem-resistant Enterobacteriaceae (CRE) among residents and in the environment of nursing homes (NHs).
DESIGN


Point prevalence sampling of residents and environmental sampling of high-touch objects in resident rooms and common areas.
SETTING


Twenty-eight NHs in Southern California from 2016 to 2017.
PARTICIPANTS


NH participants in Project PROTECT, a cluster-randomized trial of enhanced bathing and decolonization vs routine care.
METHODS


Fifty residents were randomly sampled per NH. Twenty objects were sampled, including 5 common room objects plus 5 objects in each of 3 rooms (ambulatory, total care, and dementia care residents).
RESULTS


A total of 2797 swabs were obtained from 1400 residents in 28 NHs. Median prevalence of multidrug-resistant organism (MDRO) carriage per NH was 50% (range: 24%-70%). Median prevalence of specific MDROs were as follows: MRSA, 36% (range: 20%-54%); ESBL, 16% (range: 2%-34%); VRE, 5% (range: 0%-30%); and CRE, 0% (range: 0%-8%). A median of 45% of residents (range: 24%-67%) harbored an MDRO without a known MDRO history. Environmental MDRO contamination was found in 74% of resident rooms and 93% of common areas.
CONCLUSIONS AND IMPLICATIONS


In more than half of the NHs, more than 50% of residents were colonized with MDROs of clinical and public health significance, most commonly MRSA and ESBL. Additionally, the vast majority of resident rooms and common areas were MDRO contaminated. The unknown submerged portion of the iceberg of MDRO carriers in NHs may warrant changes to infection prevention and control practices, particularly high-fidelity adoption of universal strategies such as hand hygiene, environmental cleaning, and decolonization.",2020,Median prevalence of multidrug-resistant organism (MDRO) carriage per NH was 50% (range: 24%-70%).,"['residents and environmental sampling of high-touch objects in resident rooms and common areas', '28 Nursing Homes', 'A total of 2797 swabs were obtained from 1400 residents in 28 NHs', 'NH participants', 'Fifty residents were randomly sampled per NH', 'Twenty-eight NHs in Southern California from 2016 to\xa02017', 'Twenty objects were sampled, including 5 common room objects plus 5 objects in each of 3 rooms (ambulatory, total care, and dementia care residents']","['vancomycin-resistant Enterococcus spp', 'enhanced bathing and decolonization vs routine care', 'VRE), extended-spectrum beta-lactamase producing organisms (ESBLs), and carbapenem-resistant Enterobacteriaceae (CRE']","['Environmental MDRO contamination', 'Median prevalence of specific MDROs', 'Median prevalence of multidrug-resistant organism (MDRO) carriage per NH']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0183753', 'cui_str': 'Swab'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}]","[{'cui': 'C1265175', 'cui_str': 'Vancomycin resistant enterococcus'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}, {'cui': 'C0518460', 'cui_str': 'Bathing'}, {'cui': 'C4520447', 'cui_str': 'Decolonization'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0486433', 'cui_str': 'Extended-spectrum beta lactamase'}, {'cui': 'C0029235', 'cui_str': 'Organism'}, {'cui': 'C4039163', 'cui_str': 'Carbapenem resistant Enterobacteriaceae'}]","[{'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0029235', 'cui_str': 'Organism'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",2797.0,0.115846,Median prevalence of multidrug-resistant organism (MDRO) carriage per NH was 50% (range: 24%-70%).,"[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'McKinnell', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA; Los Angeles County Department of Public Health, Healthcare Outreach Unit, Los Angeles, CA; Expert Stewardship, Newport, CA. Electronic address: Dr.McKinnell@gmail.com.'}, {'ForeName': 'Loren G', 'Initials': 'LG', 'LastName': 'Miller', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA.'}, {'ForeName': 'Raveena D', 'Initials': 'RD', 'LastName': 'Singh', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Gussin', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kleinman', 'Affiliation': 'University of Massachusetts Amherst School of Public Health and Health Sciences, Amherst, MA.'}, {'ForeName': 'Job', 'Initials': 'J', 'LastName': 'Mendez', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA.'}, {'ForeName': 'Bryn', 'Initials': 'B', 'LastName': 'Laurner', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA.'}, {'ForeName': 'Tabitha D', 'Initials': 'TD', 'LastName': 'Catuna', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Heim', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA.'}, {'ForeName': 'Raheeb', 'Initials': 'R', 'LastName': 'Saavedra', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Felix', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Torres', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Chang', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Estevez', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Mendez', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Tchakalian', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Bloomfield', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Ceja', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Franco', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Miner', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA.'}, {'ForeName': 'Aura', 'Initials': 'A', 'LastName': 'Hurtado', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA.'}, {'ForeName': 'Ratharo', 'Initials': 'R', 'LastName': 'Hean', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Varasteh', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Robinson', 'Affiliation': 'Expert Stewardship, Newport, CA; Hoag Hospital, Newport, CA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of California, Irvine School of Medicine, Irvine, CA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Tam', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of California Irvine, Orange, CA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Tjoa', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA.'}, {'ForeName': 'Jiayi', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Yamaguchi', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Custodio', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Nguyen', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA.'}, {'ForeName': 'Cassiana E', 'Initials': 'CE', 'LastName': 'Bittencourt', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of California, Irvine School of Medicine, Irvine, CA.'}, {'ForeName': 'Kaye D', 'Initials': 'KD', 'LastName': 'Evans', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of California, Irvine School of Medicine, Irvine, CA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Mor', 'Affiliation': 'Department of Health Services, Policy and Practice, Brown University School of Public Health, Providence, RI; Center of Innovation in Long-Term Services and Supports, Veterans Affairs Medical Center, Providence VA Medical Center, Providence, RI; Center for Long-Term Care Quality and Innovation, Brown University School of Public Health, Providence, RI.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'McConeghy', 'Affiliation': 'Department of Health Services, Policy and Practice, Brown University School of Public Health, Providence, RI; Center of Innovation in Long-Term Services and Supports, Veterans Affairs Medical Center, Providence VA Medical Center, Providence, RI; Center for Long-Term Care Quality and Innovation, Brown University School of Public Health, Providence, RI.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Weinstein', 'Affiliation': 'Cook County Health and Hospitals System, Chicago, IL; Department of Medicine, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Hayden', 'Affiliation': 'Department of Medicine, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Nimalie D', 'Initials': 'ND', 'LastName': 'Stone', 'Affiliation': 'Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, GA.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Steinberg', 'Affiliation': 'California Association of Long Term Care Medicine, Santa Clarita, CA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Beecham', 'Affiliation': 'The National Association of Directors of Nursing Administration in Long Term Care, Springdale, OH.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Montgomery', 'Affiliation': 'California Association of Health Facilities, Sacramento, CA.'}, {'ForeName': 'Walters', 'Initials': 'W', 'LastName': 'DeAnn', 'Affiliation': 'California Association of Health Facilities, Sacramento, CA.'}, {'ForeName': 'Ellena M', 'Initials': 'EM', 'LastName': 'Peterson', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of California, Irvine School of Medicine, Irvine, CA.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Huang', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA; Department of Medicine, Health Policy Research Institute, University of California Irvine School of Medicine, Irvine, CA.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2020.04.007']
2711,32553497,Voiced High-Frequency Oscillation or Lax Vox Technique? Immediate Effects in Dysphonic Individuals.,"OBJECTIVES


To analyze the immediate effects of voiced high-frequency oscillation (VHFO) and Lax Vox technique on vocal quality and self-reported intensity of vocal and laryngeal symptoms in individuals with behavioral dysphonia.
METHODS


This experimental, prospective, randomized cross-over study, investigated thirty adults (15 women and 15 men) with behavioral dysphonia (vocal complaints, altered voice on auditory-perceptual evaluation, vocal nodules or mucosal thickening, and incomplete glottic closure). The outcome variables analyzed were auditory-perceptual analysis, acoustic analysis (voice quality characteristics), and self-reported intensities of vocal and laryngeal symptoms. Each participant performed two exercises-VHFO and Lax Vox technique-in a random sequence for 3 minutes. A 7-day washout period was provided between the exercises. The data were analyzed using the paired t-test and Wilcoxon test (P < 0.05).
RESULTS


After VHFO, no significant difference was observed on auditory-perceptual evaluation in all participants, whereas the Lax Vox technique worsened breathiness among women (P = 0.027). VHFO significantly increased the fundamental frequency (P = 0.014) and decreased the noise harmonic ratios for women (P = 0.026). Among men, there was a decrease in shimmer parameter (P = 0.035). Moreover, symptoms such as ""lump in the throat"" (P = 0.005), ""voice loss"" (P = 0.017), and ""high-pitched voice"" (P = 0.023) decreased in women after VHFO, whereas in men, ""itchiness"" and ""hoarseness"" (P < 0.001) decreased after VHFO. The Lax Vox technique decreased ""hoarseness"" (P = 0.003) in women, without any effect in men.
CONCLUSION


The VHFO exercise provided more positive immediate effects results than the Lax Vox technique regarding vocal quality and self-reported symptom intensity in participants with behavioral dysphonia.",2020,The VHFO exercise provided more positive immediate effects results than the Lax Vox technique regarding vocal quality and self-reported symptom intensity in participants with behavioral dysphonia.,"['participants with behavioral dysphonia', 'individuals with behavioral dysphonia', 'Dysphonic Individuals', 'thirty adults (15 women and 15 men) with behavioral dysphonia (vocal complaints, altered voice on auditory-perceptual evaluation, vocal nodules or mucosal thickening, and incomplete glottic closure']","['VHFO exercise', 'voiced high-frequency oscillation (VHFO) and Lax Vox technique']","['vocal quality and self-reported symptom intensity', 'voice loss', 'hoarseness', 'noise harmonic ratios', 'auditory-perceptual evaluation', 'auditory-perceptual analysis, acoustic analysis (voice quality characteristics), and self-reported intensities of vocal and laryngeal symptoms', 'high-pitched voice', 'vocal quality and self-reported intensity of vocal and laryngeal symptoms', 'fundamental frequency']","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0028259', 'cui_str': 'Nodule'}, {'cui': 'C3686502', 'cui_str': 'Mucosal thickening'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]","[{'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C2718088', 'cui_str': 'High Frequency Oscillation Ventilation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0042943', 'cui_str': 'Vocal quality'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0003564', 'cui_str': 'Aphonia'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0241703', 'cui_str': 'High pitched voice'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",30.0,0.028443,The VHFO exercise provided more positive immediate effects results than the Lax Vox technique regarding vocal quality and self-reported symptom intensity in participants with behavioral dysphonia.,"[{'ForeName': 'RebecaLiaschiFloro', 'Initials': 'R', 'LastName': 'Silva', 'Affiliation': 'Department of Speech Hearing and Language Disorders, Faculdade de Odontologia de Bauru, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'AngélicaEmygdio da Silva', 'Initials': 'ADS', 'LastName': 'Antonetti', 'Affiliation': 'Department of Speech Hearing and Language Disorders, Faculdade de Odontologia de Bauru, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Vanessa Veis', 'Initials': 'VV', 'LastName': 'Ribeiro', 'Affiliation': 'Speech-Language Pathology Audiology Department, Universidade Federal de Sergipe, Lagarto, Sergipe, Brazil.'}, {'ForeName': 'Ana Carolina', 'Initials': 'AC', 'LastName': 'Ramos', 'Affiliation': 'Department of Speech Hearing and Language Disorders, Faculdade de Odontologia de Bauru, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alcione Ghedini', 'Initials': 'AG', 'LastName': 'Brasolotto', 'Affiliation': 'Department of Speech Hearing and Language Disorders, Faculdade de Odontologia de Bauru, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Kelly Cristina Alves', 'Initials': 'KCA', 'LastName': 'Silverio', 'Affiliation': 'Department of Speech Hearing and Language Disorders, Faculdade de Odontologia de Bauru, Universidade de São Paulo, São Paulo, Brazil. Electronic address: kellysilverio@usp.br.'}]",Journal of voice : official journal of the Voice Foundation,['10.1016/j.jvoice.2020.05.004']
2712,32553498,Substitution Voice Rehabilitation After Open Partial Horizontal Laryngectomy Through the Proprioceptive Elastic Method (PROEL): A Preliminary Study.,"OBJECTIVE


The aim was to investigate the efficacy of the Proprioceptive Elastic Method (PROEL) in the rehabilitation of the substitution voice after open partial horizontal laryngectomy (OPHL).
STUDY DESIGN


Prospective outcome study.
METHODS


Fifteen patients surgically treated by OPHL type II or type III for laryngeal cancer were recruited (experimental group). Each patient underwent a specific program of voice rehabilitation based on the PROEL method with the same speech and language pathologist. Acoustic-aerodynamic analysis: maximum phonation time (MPT); spectrographic classification (Titze's modified classification), perceptual analysis (INFVo rating scale) and self-assessments (SECEL questionnaire) were performed before the treatment (T0), after 3 months of rehabilitation (T1), and at the end of the 6-month rehabilitation program (T2). A control sample of other 15 patients who underwent OPHL type II or type III and who underwent a standard perioperative rehabilitation was randomly extracted from an historical database and compared to the experimental group.
RESULTS


Significative voice improvements between T0-T1 and T2 were found for acoustic, aerodynamic, perceptual, and self-assessments analysis in the experimental group. Significative differences were found between the experimental group at T2 and the control sample for aerodynamic, self-assessment, and perceptual analysis.
CONCLUSIONS


The results of the present study support PROEL method as an effective approach for substitution voice rehabilitation after OPHL type II and III. Randomized controlled trials on larger groups of patients are needed in future in order to compare PROEL with other rehabilitative approaches.",2020,"RESULTS


Significative voice improvements between T0-T1 and T2 were found for acoustic, aerodynamic, perceptual, and self-assessments analysis in the experimental group.","['Fifteen patients surgically treated by OPHL type II or type III for laryngeal cancer were recruited (experimental group', 'substitution voice after open partial horizontal laryngectomy (OPHL', '15 patients who underwent OPHL type II or type III and who underwent a standard perioperative rehabilitation']","['specific program of voice rehabilitation based on the PROEL method with the same speech and language pathologist', 'Acoustic-aerodynamic analysis: maximum phonation time (MPT', 'Substitution Voice Rehabilitation', 'Proprioceptive Elastic Method (PROEL', 'Open Partial Horizontal Laryngectomy Through the Proprioceptive Elastic Method (PROEL']","["" spectrographic classification (Titze's modified classification), perceptual analysis (INFVo rating scale) and self-assessments (SECEL questionnaire"", 'aerodynamic, self-assessment, and perceptual analysis', 'acoustic, aerodynamic, perceptual, and self-assessments analysis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0189236', 'cui_str': 'Partial horizontal laryngectomy'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0007107', 'cui_str': 'Malignant tumor of larynx'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0334866', 'cui_str': 'Medical pathologist'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0234778', 'cui_str': 'Maximum phonation time'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0189236', 'cui_str': 'Partial horizontal laryngectomy'}]","[{'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}]",15.0,0.0164336,"RESULTS


Significative voice improvements between T0-T1 and T2 were found for acoustic, aerodynamic, perceptual, and self-assessments analysis in the experimental group.","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Fantini', 'Affiliation': 'Head and Neck Oncology Service, Candiolo Cancer Institute, FPO IRCCS, Candiolo, Italy. Electronic address: marcofantini8811@hotmail.it.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Gallia', 'Affiliation': 'Head and Neck Oncology Service, Candiolo Cancer Institute, FPO IRCCS, Candiolo, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Borrelli', 'Affiliation': 'Otorhinolaryngology Service, San Luigi Gonzaga Hospital, University of Turin, Turin, Italy.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Pizzorni', 'Affiliation': 'Department of Biomedical and Clinical Sciences ""L. Sacco"", University of Milan, Milan, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ricci Maccarini', 'Affiliation': 'Otorhinolaryngology Service, Bufalini Hospital, Cesena, Italy.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Borragan Torre', 'Affiliation': 'Centro de Foniatria y Logopedia, Santander, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Schindler', 'Affiliation': 'Department of Biomedical and Clinical Sciences ""L. Sacco"", University of Milan, Milan, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Succo', 'Affiliation': 'Head and Neck Oncology Service, Candiolo Cancer Institute, FPO IRCCS, Candiolo, Italy; Oncology Department, University of Turin, Turin, Italy.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Crosetti', 'Affiliation': 'Head and Neck Oncology Service, Candiolo Cancer Institute, FPO IRCCS, Candiolo, Italy.'}]",Journal of voice : official journal of the Voice Foundation,['10.1016/j.jvoice.2020.04.025']
2713,32553835,Reductions in Parent Interest in Receiving Antibiotics Following a 90-Second Video Intervention in Outpatient Pediatric Clinics.,"OBJECTIVES


To assess the impact of a 90-second animated video on parents' interest in receiving an antibiotic for their child.
STUDY DESIGN


This pre-post test study enrolled English and Spanish speaking parents (n=1051) of children ages 1-5 years presenting with acute respiratory tract infection symptoms. Before meeting with their provider, parents rated their interest in receiving an antibiotic for their child, answered six true/false antibiotic knowledge questions, viewed the video, and then rated their antibiotic interest again. Parents rated their interest in receiving an antibiotic using a visual analogue scale ranging from 0-100, with 0 being ""I definitely do not want an antibiotic,"" 50 ""Neutral,"" and 100 ""I absolutely want an antibiotic.""
RESULTS


Parents were 84% female, mean age 32 (SD=6.0), 26.0% had a high school education or less, 15% Black, and 19% Hispanic. After watching the video, parents' average antibiotic interest ratings dropped 10 points (M=57.0, SD=20 to M=47.5, SD=21; P < .0001). Among parents with the highest initial antibiotic interest ratings (>60), even larger reductions were observed (M=83.0, SD=12 to M=63.4, SD=22; p<.0001) with over half (52%) rating their interest in the low or neutral ranges after watching the video.
CONCLUSIONS


A 90-second video can reduce parents' interest in receiving antibiotics, especially among those with higher baseline interest. This scalable intervention could be used in a variety of settings to reduce parents' interest in receiving antibiotics.",2020,"Among parents with the highest initial antibiotic interest ratings (>60), even larger reductions were observed (M=83.0, SD=12 to M=63.4, SD=22; p<.0001) with over half (52%) rating their interest in the low or neutral ranges after watching the video.
","['This pre-post test study enrolled English and Spanish speaking parents (n=1051) of children ages 1-5 years presenting with acute respiratory tract infection symptoms', 'Parents were 84% female, mean age 32 (SD=6.0), 26.0% had a high school education or less, 15% Black, and 19% Hispanic', ""parents' interest in receiving an antibiotic for their child"", 'Outpatient Pediatric Clinics']",['90-second animated video'],[],"[{'cui': 'C0032919', 'cui_str': 'Pre-Post Tests'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C4759838', 'cui_str': 'Acute respiratory tract infection'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0455002', 'cui_str': 'Education and schooling detail'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C3839701', 'cui_str': 'Pediatric clinic'}]","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0042655', 'cui_str': 'Video'}]",[],,0.0489348,"Among parents with the highest initial antibiotic interest ratings (>60), even larger reductions were observed (M=83.0, SD=12 to M=63.4, SD=22; p<.0001) with over half (52%) rating their interest in the low or neutral ranges after watching the video.
","[{'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Goggin', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Hospitals and Clinics, Kansas City; University of Missouri - Kansas City School of Medicine, Kansas City; University of Missouri - Kansas City School of Pharmacy, Kansas City. Electronic address: kgoggin@cmh.edu.""}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Hurley', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Hospitals and Clinics, Kansas City.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bradley-Ewing', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Hospitals and Clinics, Kansas City.""}, {'ForeName': 'Carey', 'Initials': 'C', 'LastName': 'Bickford', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Hospitals and Clinics, Kansas City.""}, {'ForeName': 'Brian R', 'Initials': 'BR', 'LastName': 'Lee', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Hospitals and Clinics, Kansas City; University of Missouri - Kansas City School of Medicine, Kansas City.""}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Pina', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Hospitals and Clinics, Kansas City.""}, {'ForeName': 'Evelyn Donis', 'Initials': 'ED', 'LastName': 'De Miranda', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Hospitals and Clinics, Kansas City.""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Mackenzie', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Hospitals and Clinics, Kansas City.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Yu', 'Affiliation': 'Sunflower Medical Group, Kansas City.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Weltmer', 'Affiliation': 'University of Missouri - Kansas City School of Medicine, Kansas City.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Linnemayr', 'Affiliation': 'RAND Corporation, Santa Monica.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Butler', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': ""University of Missouri - Kansas City School of Medicine, Kansas City; Emergency Department, Children's Mercy, Kansas City.""}, {'ForeName': 'Jason G', 'Initials': 'JG', 'LastName': 'Newland', 'Affiliation': ""Pediatric Infectious Disease, St. Louis Children's Hospital, St. Louis.""}, {'ForeName': 'Angela L', 'Initials': 'AL', 'LastName': 'Myers', 'Affiliation': ""University of Missouri - Kansas City School of Medicine, Kansas City; Pediatric Infectious Diseases, Children's Mercy, Kansas City.""}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.06.027']
2714,32550303,Evaluation of local hemostatic effect of microporous polysaccharide hemospheres products in thyroid surgery: a prospective randomized controlled study.,"Objectives


Bleeding is a rare and dangerous complication of thyroid surgery. One of the hemostatic agents used during surgery are microporous polysaccharide hemospheres (MPH) which are local hemostatic agents acquired from purified potato starch. The aim of this study was to evaluate the efficiency of two MPH, produced with different biotechniques, in decreasing hemorrhages and drainage following thyroidectomy.
Material and Methods


A statistical power analysis predicted that totally 20 patients per each group was needed within 95% confidential interval. Patients were randomized into 3 groups as control, Haemocer TM and Arista TM to be 20 patients in each group. Following bilateral total thyroidectomy, no additional procedures were performed in the first group, 5 g Haemocer was administered to the second group, 5 g Arista was administered to the third group into the operational field, and the operation was ended by placing a double-sided hemovac drain. At post-operative day one, drainage amount, calcium (Ca), phosphate (P) and parathyroid hormone (PTH) levels were noted.
Results


No significant difference was noted between the groups for age, gender, removed tissue weight and malignant pathology rates. Also, no significant difference was noted between post-operative drainages and Ca, P, PTH levels of groups either. Hoarseness or hematoma were not observed in any patient.
Conclusion


MPHs are not proven in effectiveness in decreasing post-operative hemorrhages, which might be a key to avoiding unnecessary expenses.",2019,"Also, no significant difference was noted between post-operative drainages and Ca, P, PTH levels of groups either.",['thyroid surgery'],['microporous polysaccharide hemospheres products'],"['drainage amount, calcium (Ca), phosphate (P) and parathyroid hormone (PTH) levels', 'tissue weight and malignant pathology rates', 'Hoarseness or hematoma', 'post-operative drainages and Ca, P, PTH levels']","[{'cui': 'C0193769', 'cui_str': 'Operation on thyroid gland'}]","[{'cui': 'C0032594', 'cui_str': 'Polysaccharide'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement'}]",,0.0277675,"Also, no significant difference was noted between post-operative drainages and Ca, P, PTH levels of groups either.","[{'ForeName': 'Enver', 'Initials': 'E', 'LastName': 'Kunduz', 'Affiliation': 'Bezmialem Vakıf Üniversitesi Tıp Fakültesi, Genel Cerrahi Anabilim Dalı, İstanbul, Türkiye.'}, {'ForeName': 'Erhan', 'Initials': 'E', 'LastName': 'Aysan', 'Affiliation': 'Bezmialem Vakıf Üniversitesi Tıp Fakültesi, Genel Cerrahi Anabilim Dalı, İstanbul, Türkiye.'}, {'ForeName': 'Ufuk Oğuz', 'Initials': 'UO', 'LastName': 'İdiz', 'Affiliation': 'İstanbul Eğitim ve Araştırma Hastanesi, Genel Cerrahi Kliniği, İstanbul, Türkiye.'}, {'ForeName': 'Yeliz Emine', 'Initials': 'YE', 'LastName': 'Ersoy', 'Affiliation': 'Bezmialem Vakıf Üniversitesi Tıp Fakültesi, Genel Cerrahi Anabilim Dalı, İstanbul, Türkiye.'}, {'ForeName': 'Hüseyin Kazım', 'Initials': 'HK', 'LastName': 'Bektaşoğlu', 'Affiliation': 'Bezmialem Vakıf Üniversitesi Tıp Fakültesi, Genel Cerrahi Anabilim Dalı, İstanbul, Türkiye.'}, {'ForeName': 'Samet', 'Initials': 'S', 'LastName': 'Yığman', 'Affiliation': 'Bezmialem Vakıf Üniversitesi Tıp Fakültesi, Genel Cerrahi Anabilim Dalı, İstanbul, Türkiye.'}, {'ForeName': 'Hacer', 'Initials': 'H', 'LastName': 'Kundakcıoğlu', 'Affiliation': 'Bezmialem Vakıf Üniversitesi Tıp Fakültesi, Genel Cerrahi Anabilim Dalı, İstanbul, Türkiye.'}]",Turkish journal of surgery,['10.5578/turkjsurg.4162']
2715,32550318,Therapeutic effect of gastrografin and predictors of operative intervention in patients with adhesive small bowel obstruction: A randomized controlled study.,"Objectives


The study aimed to investigate the therapeutic effect of gastrografin for the conservative treatment of patients with adhesive small bowel obstruction (ASBO) and to identify the predictors of failure of conservative treatment in these patients.
Material and Methods


A randomized controlled trial was conducted on 52 patients with the diagnosis of ASBO in 2016. 100 mL of Gastrografin and 100 mL of 0.9% saline solution were gavaged through the nasogastric tube in the case (n= 26) and control (n= 26) groups, respectively. Patients in the case group were subjected to plain abdominal X-Rays at 12, 24 and 48 hours after administration of gastrografin.
Results


Fifty-two patients with a mean age of 57.6 ± 11.4 years (range 37-81), including 34 (65.4%) males were enrolled into the study. The number of patients who were successfully conservatively treated in the case group was 21 (80.8%), which was significantly higher than 13 (50%) in the control group (p= 0.04). Among these patients, mean hospital stay in the case group was 37.2 ± 5.5 hours (range 28-46), which was significantly shorter than 45.8 ± 9.2 hours (range 36-61) in the control group (p= 0.004). In multivariate analysis, more than one previous laparotomy was the only predictor of failure of conservative treatment (p <0.001).
Conclusion


Gastrografin may be associated with improvement of patients with ASBO. Lower number of previous laparotomies may be a predictor of successful conservative treatment of these patients.",2019,"In multivariate analysis, more than one previous laparotomy was the only predictor of failure of conservative treatment (p <0.001).
","['Results\n\n\nFifty-two patients with a mean age of 57.6 ± 11.4 years (range 37-81), including 34 (65.4%) males were enrolled into the study', 'patients with adhesive small bowel obstruction', 'patients with ASBO', '52 patients with the diagnosis of ASBO in 2016', 'patients with adhesive small bowel obstruction (ASBO']","['Gastrografin and 100 mL of 0.9% saline solution', 'plain abdominal X-Rays', 'gastrografin', 'operative intervention']",['mean hospital stay'],"[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517533', 'cui_str': '11.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0235329', 'cui_str': 'Small bowel obstruction'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0733796', 'cui_str': 'Gastrografin'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0034573', 'cui_str': 'Diagnostic radiography of abdomen'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",52.0,0.0518611,"In multivariate analysis, more than one previous laparotomy was the only predictor of failure of conservative treatment (p <0.001).
","[{'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Khorshidi', 'Affiliation': 'Hamadan Tıp Bilimleri Üniversitesi, Genel Cerrahi Anabilim Dalı, Hamadan, İran.'}, {'ForeName': 'Parviz', 'Initials': 'P', 'LastName': 'Majidi', 'Affiliation': 'Hamadan Tıp Bilimleri Üniversitesi, Genel Cerrahi Anabilim Dalı, Hamadan, İran.'}, {'ForeName': 'Azar', 'Initials': 'A', 'LastName': 'Pirdehghan', 'Affiliation': 'Hamadan Tıp Bilimleri Üniversitesi, Topluluk ve Önleyici Tıp Anabilim Dalı, Hamadan, İran.'}]",Turkish journal of surgery,['10.5578/turkjsurg.4237']
2716,32550325,Single-stage treatment with ERCP and laparoscopic cholecystectomy versus two-stage treatment with ERCP followed by laparoscopic cholecystectomy within six to eight weeks: a retrospective study.,"Objectives


Obstructive jaundice is one of the earliest symptoms of a hepatobiliary system disorder. The aim of the present study was to compare single stage endoscopic retrograde cholangiopancreatography (ERCP)/laparoscopic cholecystectomy (LC) and two-stage ERCP and LC with respect to the frequency of imaging, duration of anesthesia and the length of stay in our clinic.
Material and Methods


Of the 350 patients undergoing ERCP between 01.01.2015 and 31.12.2016, 31 patients with single-stage ERCP and LC were assigned to Group A and 25 patients with two-stage ERCP followed by LC within 6-8 weeks were assigned to Group B. Eligibility criteria included ERCP duration, difficulty of the procedure, bile duct stones as demonstrated by imaging methods, no contraindications for LC and no suspected or known malignancy. The same surgeon performed ERCP and LC in both groups.
Results


No cases of morbidity or mortality occurred in any groups. The average length of stay was 8.03 ± 4.97 days in Group A, which was significantly longer (9.92 ± 4.05 days) in Group B (p <0.026). However, the length of stay (in days) was calculated as the time from presentation to hospital until discharge and not the time elapsed after the procedure. Imaging methods were used 3.9 ± 3.07 times in Group A and significantly more frequently (5.92 ± 2.55 times) in Group B (p <0.001). Total duration of anesthesia was not statistically significantly different between the study groups (154.06 ± 53.76 min in Group A and 167.04 ± 75.17 min in Group B).
Conclusion


In conclusion, single-stage ERCP/LC is associated with shorter hospital stay and lower frequency of imaging and can be safely used in selected cases. No cases of pancreatitis or mortality occurred following the single-stage procedure. The single-stage procedure can be safely used in selected patients with obstructive jaundice.",2019,"Total duration of anesthesia was not statistically significantly different between the study groups (154.06 ± 53.76 min in Group A and 167.04 ± 75.17 min in Group B).
","['selected patients with obstructive jaundice', '350 patients undergoing ERCP between 01.01.2015 and 31.12.2016, 31 patients with single-stage ERCP and LC']","['ERCP and laparoscopic cholecystectomy', 'endoscopic retrograde cholangiopancreatography (ERCP)/laparoscopic cholecystectomy (LC) and two-stage ERCP and LC', 'ERCP', 'laparoscopic cholecystectomy']","['morbidity or mortality', 'shorter hospital stay', 'Total duration of anesthesia', 'length of stay', 'average length of stay', 'pancreatitis or mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022354', 'cui_str': 'Obstructive hyperbilirubinemia'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}]",350.0,0.0341504,"Total duration of anesthesia was not statistically significantly different between the study groups (154.06 ± 53.76 min in Group A and 167.04 ± 75.17 min in Group B).
","[{'ForeName': 'Bahtiyar', 'Initials': 'B', 'LastName': 'Muhammedoğlu', 'Affiliation': 'Clinic of General Surgery, Necip Fazil City Hospital, Kahramanmaras, Turkey.'}]",Turkish journal of surgery,['10.5152/turkjsurg.2018.4204']
2717,32550535,"A 1-year prospective, open-label, single-arm, multicenter, phase 3 trial of the contraceptive efficacy and safety of the oral progestin-only pill drospirenone 4 mg using a 24/4-day regimen.","Objectives


To evaluate contraceptive effectiveness and safety of oral drospirenone 4 mg 24/4-day regimen in the United States.
Study design


We performed a prospective, single-arm, multicenter phase 3 trial in sexually active women for up to thirteen 28-day treatment cycles. Primary outcome was the Pearl index, calculated using confirmed on-drug pregnancies and evaluable cycles in nonbreastfeeding women aged ≤ 35 years. We assessed adverse events (AEs), including hyperkalemia and venous thromboembolism.
Results


Of 1006 women who received at least one dose of drospirenone, 352 women (35.0%) completed the trial and 654 (65.0%) women discontinued before trial end. Most participants (92.2%) were ≤ 35 years; one third had a body mass index (BMI) ≥ 30 kg/m 2 . Among nonbreastfeeding women aged ≤ 35 years, there were 17 pregnancies (Pearl index: 4.0; 95% confidence interval [CI], 2.3-6.4;  n  = 953), of which three were unconfirmed and two were from sites excluded from the main analysis for major breaches of Food and Drug Administration regulations. The Pearl index was 2.9 (95% CI: 1.5-5.1) for confirmed pregnancies among 915 nonbreastfeeding women aged ≤ 35 years from sites with no protocol violations. Nearly all (95.4%) treatment-emergent AEs were mild or moderate in intensity. No cases of venous thromboembolism were reported. The frequency of hyperkalemia was 0.5%. Women with baseline systolic/diastolic blood pressure ≥ 130/85 mmHg had a mean reduction from baseline in blood pressure at exit visit (- 8.5/- 4.9 mmHg;  n  = 119). No other clinically relevant changes were observed. Participant satisfaction was high.
Conclusion


Drospirenone 4 mg 24/4 regimen provides effective contraception with a good safety/tolerability profile in a broad group of women, including overweight or obese women.
Implications


This new progestin-only contraceptive, drospirenone 4 mg in a 24/4 regimen, provides a contraceptive option for the majority of women regardless of blood pressure or BMI.",2020,The Pearl index was 2.9 (95% CI: 1.5-5.1) for confirmed pregnancies among 915 nonbreastfeeding women aged ≤ 35 years from sites with no protocol violations.,"['Women with baseline systolic/diastolic blood pressure\u202f≥\u202f130/85\u202fmmHg had a mean reduction from baseline in blood pressure at exit visit (-\xa08.5', 'in a broad group of women, including overweight or obese women', 'sexually active women for up to thirteen 28-day treatment cycles', 'nonbreastfeeding women aged ≤\xa035\u202fyears, there were 17 pregnancies (Pearl index: 4.0; 95% confidence interval [CI], 2.3-6.4;  n \u202f=\u202f953), of which three were unconfirmed and two were from sites excluded from the main analysis for major breaches of Food and Drug Administration regulations', '1006 women who received at least one dose of drospirenone, 352 women (35.0%) completed the trial and 654 (65.0%) women discontinued before trial end']","['oral drospirenone', 'progestin-only contraceptive, drospirenone', 'oral progestin-only pill drospirenone', 'Drospirenone']","['safety/tolerability profile', 'body mass index (BMI) ≥', 'contraceptive effectiveness and safety', 'venous thromboembolism', 'Pearl index', 'adverse events (AEs), including hyperkalemia and venous thromboembolism', 'frequency of hyperkalemia', 'blood pressure or BMI', 'Pearl index, calculated using confirmed on-drug pregnancies and evaluable cycles']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0337094', 'cui_str': 'Exit'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0241028', 'cui_str': 'Sexually active'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0043822', 'cui_str': 'drospirenone'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0444930', 'cui_str': 'End'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0043822', 'cui_str': 'drospirenone'}, {'cui': 'C0033306', 'cui_str': 'Progestational hormone'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4505082', 'cui_str': 'Birth Control Effectiveness'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]",1006.0,0.349703,The Pearl index was 2.9 (95% CI: 1.5-5.1) for confirmed pregnancies among 915 nonbreastfeeding women aged ≤ 35 years from sites with no protocol violations.,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kimble', 'Affiliation': 'Eastern Virginia Medical School, Norfolk, VA, USA.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Burke', 'Affiliation': 'Department of Gynecology and Obstetrics, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Kurt T', 'Initials': 'KT', 'LastName': 'Barnhart', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Archer', 'Affiliation': 'Eastern Virginia Medical School, Norfolk, VA, USA.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Colli', 'Affiliation': 'Exeltis, Madrid, Spain.'}, {'ForeName': 'Carolyn L', 'Initials': 'CL', 'LastName': 'Westhoff', 'Affiliation': 'Department of Obstetrics and Gynecology, and Mailman School of Public Health, Columbia University, New York, NY, USA.'}]",Contraception: X,['10.1016/j.conx.2020.100020']
2718,32550640,Correction to: Adjusted tight control blood glucose management in diabetic patients undergoing on pump coronary artery bypass graft. A randomized clinical trial.,[This corrects the article DOI: 10.1007/s40200-020-00494-4.].,2020,[This corrects the article DOI: 10.1007/s40200-020-00494-4.].,['diabetic patients undergoing on pump coronary artery bypass graft'],['Correction to: Adjusted tight control blood glucose management'],[],"[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1638311', 'cui_str': 'Blood glucose management'}]",[],,0.0418528,[This corrects the article DOI: 10.1007/s40200-020-00494-4.].,"[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Javaherforoosh Zadeh', 'Affiliation': 'Department of Anesthesia, Ahvaz Anesthesiology and Pain Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Azemati', 'Affiliation': 'Anesthesiology and Critical Care Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Journal of diabetes and metabolic disorders,['10.1007/s40200-020-00500-9']
2719,31298607,Comparison of the Efficacy of Topical Chloramphenicol 0.5%-Betamethasone 0.2% (CB) and CB Associated with Sodium Hyaluronate/Trehalose/Carbomer Gel Following Strabismus Surgery.,"Purpose:  To compare the efficacy of topical chloramphenicol 0.5%-betamethasone 0.2% (CB) and CB associated with sodium hyaluronate/trehalose/carbomer (HTC-gel) gel following strabismus surgery.  Methods:  Longitudinal, single-arm, study case series analysis involved patients undergoing bilateral symmetrical horizontal strabismus surgery. One eye received CB alone and the contralateral eye CB and HTC-gel. Both treatments were instilled 3 times a day for 4 weeks postoperatively. Ocular inflammation was assessed objectively at 1 and 4 weeks by Efron scale for conjunctival redness. Foreign body sensation, burning/stinging, itching, pain, stick feeling, and blurred vision were evaluated by the numerical rating scale.  Results:  There were 31 patients included in the study. The mean age at presentation was 51 years (standard deviation 24, range 19-85). Conjunctival inflammatory at 1 and 4 weeks showed no statistically significant difference between the 2 treatments ( P  = 0.75 and  P  = 0.33, respectively). At 1 week postsurgery, all the subjective parameters showed a significant difference ( P  < 0.0001) between the 2 groups of treatment to the exclusion of ""itching"" and ""pain"" ( P  = 0.18 and  P  = 0.67, respectively) with higher scores, to the exception of ""blurred vision"" in the CB treatment. At 4 weeks postoperatively, no statistically significant differences between the 2 groups ( P  > 0.16) of treatments were observed, with the exception of the symptom ""blurred vision"" (0.00 vs. 1.65, CB vs. CB and HTC-gel, respectively,  P  < 0.0001).  Conclusion:  CB associated with HTC-gel seems to be an effective treatment option following strabismus surgery.",2019,"Conjunctival inflammatory at 1 and 4 weeks showed no statistically significant difference between the 2 treatments ( P  = 0.75 and  P  = 0.33, respectively).","['Strabismus Surgery', '31 patients included in the study', 'patients undergoing bilateral symmetrical horizontal strabismus surgery', 'The mean age at presentation was 51 years (standard deviation 24, range 19-85']","['HTC-gel', 'CB alone and the contralateral eye CB and HTC-gel', 'topical chloramphenicol 0.5%-betamethasone 0.2% (CB) and CB associated with sodium hyaluronate/trehalose/carbomer (HTC-gel) gel', 'Topical Chloramphenicol 0.5%-Betamethasone 0.2% (CB) and CB Associated with Sodium Hyaluronate/Trehalose/Carbomer Gel']","['Ocular inflammation', 'Foreign body sensation, burning/stinging, itching, pain, stick feeling, and blurred vision', 'itching"" and ""pain', 'symptom ""blurred vision', 'Conjunctival inflammatory']","[{'cui': 'C0197981', 'cui_str': 'Strabismus surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0008168', 'cui_str': 'Chloramphenicol'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0087000', 'cui_str': 'Hyaluronate sodium'}, {'cui': 'C0040815', 'cui_str': 'Trehalose'}, {'cui': 'C0770624', 'cui_str': 'Carbomer'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0423602', 'cui_str': 'Foreign body sensation'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0677500', 'cui_str': 'Stinging'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1706582', 'cui_str': 'Stick'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0344232', 'cui_str': 'Hazy vision'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0218288,"Conjunctival inflammatory at 1 and 4 weeks showed no statistically significant difference between the 2 treatments ( P  = 0.75 and  P  = 0.33, respectively).","[{'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Vagge', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DiNOGMI), Eye Clinic of Genoa, Policlinico San Martino, University of Genova, Genova, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Giannaccare', 'Affiliation': 'Ophthalmology Unit, Department of Experimental Diagnostic and Specialty Medicine (DIMES), University of Bologna, S. Orsola-Malpighi Teaching Hospital, Bologna, Italy.'}, {'ForeName': 'Carlo Enrico', 'Initials': 'CE', 'LastName': 'Traverso', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DiNOGMI), Eye Clinic of Genoa, Policlinico San Martino, University of Genova, Genova, Italy.'}]",Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics,['10.1089/jop.2019.0007']
2720,31385712,Conversations about binge drinking among vocational community college students: the relation with drinking attitudes and intentions and the moderating role of conversation partner popularity.,"Objective:  The association between conversational valence (i.e. how positive/negative people perceive their conversations to be) and binge-drinking attitudes and intentions has been well established. However, too few studies have recognised a potential reciprocal association as well as the potential role of the conversation partner. In order to address these gaps, this study explored whether conversational valence and binge-drinking attitudes and intentions were reciprocally associated and whether this association was moderated by conversation partner popularity.  Design:  Vocational community college students ( N  = 112,  M age  = 18.09) participated in a two-wave study (one month between the waves).  Methods.  Binge-drinking attitudes and intentions, and popularity were measured at baseline. At the second wave, conversational valence, and binge-drinking attitudes and intentions were assessed.  Results:  In revealing that only conversational valence was indicative of binge-drinking attitudes and intentions, it was shown that conversational valence and binge-drinking attitudes and intentions were not reciprocally associated. Furthermore, it was shown that conversation-partner popularity moderated the association between conversational valence and binge-drinking attitudes.  Conclusion:  Conversational valence was shown to be indicative of binge-drinking attitudes and intentions, and not vice versa. Furthermore, after talking to a popular conversation partner, adolescents' attitudes towards binge drinking became more positive.",2020,"Furthermore, it was shown that conversation-partner popularity moderated the association between conversational valence and binge-drinking attitudes.  ","['vocational community college students', 'Vocational community college students ( N \u2009=\u2009112,  M age  = 18.09) participated in a two-wave study (one month between the waves']",['conversational valence'],"['conversational valence and binge-drinking attitudes and intentions', 'Binge-drinking attitudes and intentions, and popularity']","[{'cui': 'C0557812', 'cui_str': 'Community college'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4082115', 'cui_str': 'One month'}]",[],"[{'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",,0.011665,"Furthermore, it was shown that conversation-partner popularity moderated the association between conversational valence and binge-drinking attitudes.  ","[{'ForeName': 'Elroy', 'Initials': 'E', 'LastName': 'Boers', 'Affiliation': 'Department of Psychiatry, University of Montreal, CHU Sainte Justine Research Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Hanneke', 'Initials': 'H', 'LastName': 'Hendriks', 'Affiliation': 'Amsterdam School of Communication Research (ASCoR), University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'van den Putte', 'Affiliation': 'Amsterdam School of Communication Research (ASCoR), University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Beentjes', 'Affiliation': 'Amsterdam School of Communication Research (ASCoR), University of Amsterdam, Amsterdam, the Netherlands.'}]",Psychology & health,['10.1080/08870446.2019.1649673']
2721,32556960,Corticosteroids to prevent kidney scarring in children with a febrile urinary tract infection: a randomized trial.,"BACKGROUND


To evaluate the efficacy of adjuvant systemic corticosteroids in reducing kidney scarring. A previous study suggested that use of adjuvant systemic corticosteroids reduces kidney scarring in children radiologically confirmed to have extensive pyelonephritis. Efficacy of corticosteroids for children with febrile urinary tract infection (UTI) has not been studied.
METHODS


Children aged 2 months to 6 years with their first febrile UTI were randomized to corticosteroids or placebo for 3 days (both arms received antimicrobial therapy); kidney scarring was assessed using  99m Tc-dimercaptosuccinic acid kidney scan 5-24 months after the initial UTI.
RESULTS


We randomized 546 children of which 385 had a UTI and 254 had outcome kidney scans (instead of the 320 planned). Rates of kidney scarring were 9.8% (12/123) and 16.8% (22/131) in the corticosteroid and placebo groups, respectively (p = 0.16), corresponding to an absolute risk reduction of 5.9% (95% confidence interval: - 2.2, 14.1).
CONCLUSION


While children randomized to adjuvant corticosteroids tended to develop fewer kidney scars than children who were randomized to receive placebo, a statistically significant difference was not achieved. However, the study was limited by not reaching its intended sample size.
CLINICAL TRIAL REGISTRATION


Clinicaltrials.gov, NCT01391793, Registered 7/12/2011 Graphical abstract.",2020,"Rates of kidney scarring were 9.8% (12/123) and 16.8% (22/131) in the corticosteroid and placebo groups, respectively (p = 0.16), corresponding to an absolute risk reduction of 5.9% (95% confidence interval: - 2.2, 14.1).
","['children with febrile urinary tract infection (UTI', 'Children aged 2\xa0months to 6\xa0years with their first febrile UTI', 'children with a febrile urinary tract infection', '546 children of which 385 had a UTI and 254 had outcome kidney scans (instead of the 320 planned']","['adjuvant systemic corticosteroids', 'corticosteroids or placebo', 'corticosteroids', 'Corticosteroids', 'antimicrobial therapy); kidney scarring was assessed using  99m', 'placebo']","['kidney scarring', 'kidney scars', 'Rates of kidney scarring']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3875265', 'cui_str': 'Febrile urinary tract infection'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C4517751', 'cui_str': '385'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0412412', 'cui_str': 'Kidney imaging with function study'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0017658', 'cui_str': 'Glomerulonephritis'}]","[{'cui': 'C0017658', 'cui_str': 'Glomerulonephritis'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}]",546.0,0.616011,"Rates of kidney scarring were 9.8% (12/123) and 16.8% (22/131) in the corticosteroid and placebo groups, respectively (p = 0.16), corresponding to an absolute risk reduction of 5.9% (95% confidence interval: - 2.2, 14.1).
","[{'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Shaikh', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA. nader.shaikh@chp.edu.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Shope', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Hoberman', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Gysella B', 'Initials': 'GB', 'LastName': 'Muniz', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Sonika', 'Initials': 'S', 'LastName': 'Bhatnagar', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Nowalk', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Hickey', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Marian G', 'Initials': 'MG', 'LastName': 'Michaels', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Kearney', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Howard E', 'Initials': 'HE', 'LastName': 'Rockette', 'Affiliation': 'Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Charron', 'Affiliation': 'Department of Radiology, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Lim', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Massoud', 'Initials': 'M', 'LastName': 'Majd', 'Affiliation': ""Children's National Health System, Washington, DC, USA.""}, {'ForeName': 'Eglal', 'Initials': 'E', 'LastName': 'Shalaby-Rana', 'Affiliation': ""Children's National Health System, Washington, DC, USA.""}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Kurs-Lasky', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Cohen', 'Affiliation': ""Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Ellen R', 'Initials': 'ER', 'LastName': 'Wald', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Lockhart', 'Affiliation': ""Hasbro Children's Hospital, Alpert Medical School, Providence, RI, USA.""}, {'ForeName': 'Hans G', 'Initials': 'HG', 'LastName': 'Pohl', 'Affiliation': ""Children's National Health System, Washington, DC, USA.""}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Martin', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}]","Pediatric nephrology (Berlin, Germany)",['10.1007/s00467-020-04622-3']
2722,32557000,Comparison of a fractional 2940-nm Er:YAG laser and 5% amorolfine lacquer combination therapy versus a 5% amorolfine lacquer monotherapy for the treatment of onychomycosis: a randomized controlled trial.,"Onychomycosis is a fungal infection of the nail. The aim of this randomized controlled clinical trial was to compare the efficacy of 2940-nm Er:YAG laser treatment combined with a 5% amorolfine lacquer versus amorolfine monotherapy for treating onychomycosis. In this study, patients with onychomycosis of the great toenail were randomly assigned to a combination therapy group and a monotherapy group. In the combination therapy group, the included toenails were treated with a fractional 2940-nm Er:YAG laser at weeks 1, 2, 3, 4, 8, and 12, combined with a 5% amorolfine lacquer twice a week for 12 weeks, while in the monotherapy group, the included toenails were treated with only a 5% amorolfine lacquer twice a week for 12 weeks. The onychomycosis severity index (OSI) score and the mycological clearance rate (MCR) of the included toenails were assessed at baseline, week 12, and week 24. At weeks 12 and 24, the great toenails with mild and moderate onychomycosis in the combination therapy group showed obvious improvement and a greater decrease in OSI than those in the monotherapy group. At week 24, the toenails with mild and moderate onychomycosis in the combination therapy group also showed a better MCR. For the toenails with severe onychomycosis, little improvement was observed in either group at week 12 or week 24. In conclusion, fractional 2940-nm Er:YAG laser treatment combined with a 5% amorolfine lacquer is more effective than amorolfine monotherapy in short-term improvement of onychomycosis.",2020,"For the toenails with severe onychomycosis, little improvement was observed in either group at week 12 or week 24.","['onychomycosis', 'patients with onychomycosis of the great toenail']","['monotherapy', 'Er:YAG laser and 5% amorolfine lacquer combination therapy', 'fractional 2940-nm', 'amorolfine monotherapy', 'amorolfine lacquer', 'amorolfine lacquer monotherapy', 'amorolfine lacquer versus amorolfine monotherapy']","['toenails with mild and moderate onychomycosis', 'onychomycosis', 'fractional 2940-nm', 'onychomycosis severity index (OSI) score and the mycological clearance rate (MCR) of the included toenails', 'OSI', 'great toenails with mild and moderate onychomycosis']","[{'cui': 'C0040261', 'cui_str': 'Onychomycosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0222007', 'cui_str': 'Toenails'}]","[{'cui': 'C0457903', 'cui_str': 'Erbium:YAG laser device'}, {'cui': 'C0051736', 'cui_str': 'Amorolfine'}, {'cui': 'C0022902', 'cui_str': 'Lacquer'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0222007', 'cui_str': 'Toenails'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0040261', 'cui_str': 'Onychomycosis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205467', 'cui_str': 'Mycologic'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205393', 'cui_str': 'Most'}]",,0.0215002,"For the toenails with severe onychomycosis, little improvement was observed in either group at week 12 or week 24.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Dermatology and Venereology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong Province, China. zhangj0811@126.com.'}, {'ForeName': 'Yunqing', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Dermatology and Venereology, The Third Affiliated Hospital of Sun Yat-sen University, Guangdong Province, Guangzhou, China.'}, {'ForeName': 'Jinglin', 'Initials': 'J', 'LastName': 'Qin', 'Affiliation': 'Department of Dermatology and Venereology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Sha', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Department of Dermatology and Venereology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Wenying', 'Initials': 'W', 'LastName': 'Cai', 'Affiliation': 'Department of Dermatology and Venereology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Jiahao', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology and Venereology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Huaiqiu', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Dermatology and Venereology, The Third Affiliated Hospital of Sun Yat-sen University, Guangdong Province, Guangzhou, China.'}, {'ForeName': 'Sulian', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Dermatology and Venereology, The Third Affiliated Hospital of Sun Yat-sen University, Guangdong Province, Guangzhou, China.'}, {'ForeName': 'Liyan', 'Initials': 'L', 'LastName': 'Xi', 'Affiliation': 'Department of Dermatology and Venereology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong Province, China.'}]",Lasers in medical science,['10.1007/s10103-020-03054-7']
2723,32557087,Thromboelastometry and a hemostasis management system are most beneficial for guiding hemostatic therapy in cardiac surgery patients with a EuroSCORE II of ≥1.83%: a randomized controlled two-step trial.,"PURPOSE


We evaluated the efficacy of hemostatic therapy based on point-of-care (POC) testing in patients undergoing cardiac surgery.
METHODS


This was a single-institution, prospective, randomized, double-blinded study. In step 1, 90 patients scheduled for elective cardiac surgery underwent complete blood count and fibrinogen measurements at baseline, after cardiopulmonary bypass (CPB) initiation (CPB start), just after CPB end, and in the intensive care unit (ICU). In step 2, 72 patients scheduled for elective cardiac surgery underwent conventional laboratory coagulation tests (control group) or POC coagulation tests (POC group). Transfusions were prepared using the fibrinogen and platelet values at mainly ""CPB start"" for the control group, and using the ROTEM values at mainly ""CPB end"" for the POC group. Consequently, the step 2 patients were divided into high- and low-risk subgroups based on the EuroSCORE II by logistic regression analysis; transfusion data and bleeding volumes were compared between the control and POC groups within the high- and low-risk subgroups.
RESULTS


In step 1, all blood components were significantly decreased at CPB start compared with baseline, and platelet and fibrinogen levels remained almost constant from CPB start to end. In step 2, the transfusion rates and perioperative bleeding volumes did not significantly differ between the control and POC groups. Subgroup analysis suggested that only the high-risk subgroup significantly differed regarding perioperative red blood cell transfusion and total bleeding volume in the ICU.
CONCLUSIONS


POC testing is beneficial for cardiac surgery patients with a EuroSCORE II of ≥1.83%.",2020,"In step 1, all blood components were significantly decreased at CPB start compared with baseline, and platelet and fibrinogen levels remained almost constant from CPB start to end.","['72 patients scheduled for elective cardiac surgery underwent', 'cardiac surgery patients with a EuroSCORE II of ≥1.83', '90 patients scheduled for elective cardiac surgery', 'patients undergoing cardiac surgery']","['Thromboelastometry and a hemostasis management system', 'hemostatic therapy', 'conventional laboratory coagulation tests (control group) or POC coagulation tests (POC group']","['transfusion rates and perioperative bleeding volumes', 'platelet and fibrinogen levels', 'perioperative red blood cell transfusion and total bleeding volume', 'blood components']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3164744', 'cui_str': 'European system for cardiac operative risk evaluation'}]","[{'cui': 'C3661505', 'cui_str': 'Thromboelastometry'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1504378', 'cui_str': 'Coagulation test'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0337428', 'cui_str': 'Fibrinogen assay'}, {'cui': 'C0086252', 'cui_str': 'Transfusion of red blood cells'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0085430', 'cui_str': 'Transfusion of blood component'}]",90.0,0.0886223,"In step 1, all blood components were significantly decreased at CPB start compared with baseline, and platelet and fibrinogen levels remained almost constant from CPB start to end.","[{'ForeName': 'Mitsuharu', 'Initials': 'M', 'LastName': 'Kodaka', 'Affiliation': ""Department of Anesthesiology and Intensive Care, Tokyo Women's Medical University Medical Center East, Arakawa-ku, Tokyo, 116-8567, Japan. kmkodaka@cb3.so-net.ne.jp.""}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Ichikawa', 'Affiliation': ""Department of Anesthesiology and Intensive Care, Tokyo Women's Medical University Medical Center East, Arakawa-ku, Tokyo, 116-8567, Japan.""}, {'ForeName': 'Kazuyoshi', 'Initials': 'K', 'LastName': 'Ando', 'Affiliation': ""Department of Anesthesiology and Intensive Care, Tokyo Women's Medical University Medical Center East, Arakawa-ku, Tokyo, 116-8567, Japan.""}, {'ForeName': 'Makiko', 'Initials': 'M', 'LastName': 'Komori', 'Affiliation': ""Department of Anesthesiology and Intensive Care, Tokyo Women's Medical University Medical Center East, Arakawa-ku, Tokyo, 116-8567, Japan.""}]",Journal of anesthesia,['10.1007/s00540-020-02810-x']
2724,32557133,"Persistent Barriers to Smoking Cessation Among Urban, Underserved Women: A Feasibility Study of Tailored Barriers Text Messages.","OBJECTIVES


Despite health risks for themselves and their children, urban underserved women smoke at high rates postpartum. The postpartum period is a stressful transition time that presents unique barriers to sustained cessation. There is limited extant evidence of efficacious psychosocial programs to maintain postpartum smoking cessation.
METHODS


Guided by the Cognitive-Social Health Information Processing model, we explored the feasibility of TxT2Commit, a text-messaging intervention designed to prevent postpartum smoking relapse. Participants (n = 43) received supportive cessation-focused text messages for one month postpartum. Using a convergent mixed method design, surveys and interviews assessed changes in psychosocial factors and smoking status through a three month follow-up.
RESULTS


Participants reported satisfaction with TxT2Commit, rating text messages as helpful, understandable, supportive, and not bothersome. However, a majority of women (n = 28, 65.1%) relapsed by three months. Participants who stayed smoke free (i.e., non-relapsers) reported significantly less temptation to smoke at one and three months postpartum compared to relapsers (ps < .01). While relapsers had significantly less temptation at one month compared to baseline, temptation increased by three months (p < .01). Consistent with the quantitative results, qualitative interviews identified informational and coping needs, with continued temptation throughout the three months. Non-relapsers were able to manage temptation and reported greater support.
CONCLUSIONS FOR PRACTICE


TxT2Commit demonstrates preliminary feasibility and acceptability among urban, underserved postpartum women. However, most participants relapsed by three months postpartum. Additional research is needed to identify targeted messaging to best help women avoid temptation and bolster support to stay smoke free in this uniquely stressful period.",2020,"While relapsers had significantly less temptation at one month compared to baseline, temptation increased by three months (p < .01).","['urban underserved women smoke at high rates postpartum', 'urban, underserved postpartum women', 'Urban, Underserved Women']","['Smoking Cessation', 'supportive cessation-focused text messages for one month postpartum']","['postpartum smoking relapse', 'psychosocial factors and smoking status', 'temptation to smoke', 'satisfaction with TxT2Commit, rating text messages as helpful, understandable, supportive, and not bothersome']","[{'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}]","[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]","[{'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]",,0.0255218,"While relapsers had significantly less temptation at one month compared to baseline, temptation increased by three months (p < .01).","[{'ForeName': 'E K', 'Initials': 'EK', 'LastName': 'Tagai', 'Affiliation': 'Cancer Prevention and Control, Fox Chase Cancer Center/Temple University Health System, 333 Cottman Avenue, Philadelphia, PA, 19111, USA.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Miller', 'Affiliation': 'Cancer Prevention and Control, Fox Chase Cancer Center/Temple University Health System, 333 Cottman Avenue, Philadelphia, PA, 19111, USA. Suzanne.Miller@fccc.edu.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Belfiglio', 'Affiliation': 'Cancer Prevention and Control, Fox Chase Cancer Center/Temple University Health System, 333 Cottman Avenue, Philadelphia, PA, 19111, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Cancer Prevention and Control, Fox Chase Cancer Center/Temple University Health System, 333 Cottman Avenue, Philadelphia, PA, 19111, USA.'}, {'ForeName': 'K Y', 'Initials': 'KY', 'LastName': 'Wen', 'Affiliation': 'Cancer Prevention and Control, Fox Chase Cancer Center/Temple University Health System, 333 Cottman Avenue, Philadelphia, PA, 19111, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hernandez', 'Affiliation': 'Obstetrics, Gynecology, and Reproductive Sciences, Lewis Katz School of Medicine, Temple University, 3500 N. Broad Street, Philadelphia, PA, 19410, USA.'}]",Maternal and child health journal,['10.1007/s10995-020-02963-x']
2725,32557382,Dupilumab Provides Favorable Safety and Sustained Efficacy for up to 3 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis.,"BACKGROUND


Management of moderate-to-severe atopic dermatitis (AD) commonly requires long-term treatment.
OBJECTIVE


The aim of this study was to report the safety and efficacy of dupilumab treatment for up to 3 years in adults with moderate-to-severe AD.
METHODS


This ongoing, multicenter, open-label extension study (LIBERTY AD OLE; NCT01949311) assessed dupilumab treatment in adults previously enrolled in dupilumab trials. Patients received dupilumab 300 mg weekly up to 148 weeks. The primary outcome was safety.
RESULTS


Of 2677 patients enrolled and treated, 347 reached week 148. Mean self-reported drug compliance was 98.2%. Safety data were consistent with previously reported trials (270.1 adverse events [AEs]/100 patient-years; 6.9 serious AEs/100 patient-years) and the known dupilumab safety profile. Common AEs (≥ 5% of patients) included nasopharyngitis, AD, upper respiratory tract infection, conjunctivitis, headache, oral herpes, and injection-site reactions. AD signs and symptoms showed sustained improvements during treatment with mean (standard deviation, mean percentage change from parent study baseline) Eczema Area and Severity Index 1.4 (3.2, - 95.4%) and weekly Pruritus Numerical Rating Scale 2.2 (1.8, - 65.4%) at week 148.
LIMITATIONS


No control arm; fewer patients at later time points; regimen different from the approved 300 mg every 2 weeks dose.
CONCLUSION


These safety and efficacy results support dupilumab as a continuous long-term treatment for adults with moderate-to-severe AD.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT01949311. Dupilumab provides favorable safety and sustained efficacy for up to 3 years in an open-label study of adults with moderate-to-severe atopic dermatitis (MP4  139831 kb).",2020,"Eczema Area and Severity Index 1.4 (3.2, - 95.4%) and weekly Pruritus Numerical Rating Scale 2.2 (1.8, - 65.4%) at week 148.
","['Adults with Moderate-to-Severe Atopic Dermatitis', 'adults with moderate-to-severe atopic dermatitis (MP4 \xa0139831 kb', 'adults previously enrolled in dupilumab trials', '2677 patients enrolled and treated, 347 reached week 148', 'adults with moderate-to-severe AD']","['dupilumab 300\xa0mg weekly up to 148\xa0weeks', 'dupilumab']","['weekly Pruritus Numerical Rating Scale', 'Mean self-reported drug compliance', 'nasopharyngitis, AD, upper respiratory tract infection, conjunctivitis, headache, oral herpes, and injection-site reactions', 'safety', 'safety and efficacy', 'Eczema Area and Severity Index']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0009763', 'cui_str': 'Conjunctivitis'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0341012', 'cui_str': 'Oral herpes simplex infection'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",2677.0,0.0596092,"Eczema Area and Severity Index 1.4 (3.2, - 95.4%) and weekly Pruritus Numerical Rating Scale 2.2 (1.8, - 65.4%) at week 148.
","[{'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Beck', 'Affiliation': 'Department of Dermatology, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Diamant', 'Initials': 'D', 'LastName': 'Thaçi', 'Affiliation': 'University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Deleuran', 'Affiliation': 'Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research, Portland, OR, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bissonnette', 'Affiliation': 'Innovaderm Research, Montreal, QC, Canada.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'de Bruin-Weller', 'Affiliation': 'National Expertise Center of Atopic Dermatitis, Department of Dermatology and Allergology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Hide', 'Affiliation': 'Department of Dermatology, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Sher', 'Affiliation': 'Peninsula Research Associates, Rolling Hills Estates, CA, USA.'}, {'ForeName': 'Iftikhar', 'Initials': 'I', 'LastName': 'Hussain', 'Affiliation': 'Vital Prospects Clinical Research Institute, PC, Tulsa, OK, USA.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Rd, Tarrytown, NY, 10591, USA.'}, {'ForeName': 'Faisal A', 'Initials': 'FA', 'LastName': 'Khokhar', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Rd, Tarrytown, NY, 10591, USA.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Beazley', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Rd, Tarrytown, NY, 10591, USA.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Ruddy', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Rd, Tarrytown, NY, 10591, USA.'}, {'ForeName': 'Naimish', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Neil M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Rd, Tarrytown, NY, 10591, USA.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Ardeleanu', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Rd, Tarrytown, NY, 10591, USA.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Shumel', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Rd, Tarrytown, NY, 10591, USA. brad.shumel@regeneron.com.'}]",American journal of clinical dermatology,['10.1007/s40257-020-00527-x']
2726,32557384,The Influence of Laparoscopic Sleeve Gastrectomy on Body Composition and Fat Distribution in Obese Caucasian Men and Women.,"BACKGROUND


The aim of the study was to assess changes in body composition in patients subjected to laparoscopic sleeve gastrectomy (LSG).
METHODS


Changes in body composition following LSG were determined in a group of 155 patients with obesity (117 women and 38 men), with dual-energy X-ray absorptiometry (DXA). Whole body fat mass (FM) and lean body mass (LBM) were determined, and abdominal fat mass (AbdF) was assessed within the region extending from the top of the pubic bone up to the line between 12th thoracic and 1st lumbar vertebras.
RESULTS


Over the period of 12 months following LSG, body mass index decreased by 28.2 ± 9.0% (p < 0.001). The reduction of body weight by 35.4 ± 12.6 kg (p < 0.001) was the result of a decrease in FM by 23.9 ± 8.9 kg (p < 0.001) and LBM by 10.5 ± 3.8 kg (p < 0.001). AbdF decreased from 13.2 ± 3.1 to 8.2 ± 2.7 kg (p < 0.001), but abdominal fat to total fat mass ratio increased from 24.9 ± 4.7 to 28.0 ± 5.8% (p < 0.001). The loss of AbdF was more pronounced in men than in women. The rate of FM loss was attenuated with patients' age.
CONCLUSIONS


Over the period of 12 months following LSG, the reduction of FM was more than twice as much as decrease of LBM. The loss of AbdF was slower than a loss of peripheral subcutaneous fat.",2020,The reduction of body weight by 35.4 ± 12.6 kg (p < 0.001) was the result of a decrease in FM by 23.9 ± 8.9 kg (p < 0.001) and LBM by 10.5 ± 3.8 kg (p < 0.001).,"['patients subjected to', '155 patients with obesity (117 women and 38 men), with dual-energy X-ray absorptiometry (DXA', 'Obese Caucasian Men and Women']","['Laparoscopic Sleeve Gastrectomy', 'laparoscopic sleeve gastrectomy (LSG']","['rate of FM loss', 'FM', 'body mass index', 'reduction of body weight', 'body composition', 'abdominal fat to total fat mass ratio', 'LBM', 'loss of AbdF', 'Body Composition and Fat Distribution', 'Whole body fat mass (FM) and lean body mass (LBM', 'reduction of FM']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1563742', 'cui_str': 'Fat, Abdominal'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1264679', 'cui_str': 'Mass ratio'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}]",155.0,0.0416692,The reduction of body weight by 35.4 ± 12.6 kg (p < 0.001) was the result of a decrease in FM by 23.9 ± 8.9 kg (p < 0.001) and LBM by 10.5 ± 3.8 kg (p < 0.001).,"[{'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Tałałaj', 'Affiliation': 'Department of Geriatrics, Internal Medicine and Metabolic Bone Diseases, Centre of Postgraduate Medical Education, Orłowski Hospital, Czerniakowska 231, 00-416, Warsaw, Poland. marektalalaj@op.pl.'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Bogołowska-Stieblich', 'Affiliation': 'Department of Geriatrics, Internal Medicine and Metabolic Bone Diseases, Centre of Postgraduate Medical Education, Orłowski Hospital, Czerniakowska 231, 00-416, Warsaw, Poland.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Wąsowski', 'Affiliation': 'Department of Geriatrics, Internal Medicine and Metabolic Bone Diseases, Centre of Postgraduate Medical Education, Orłowski Hospital, Czerniakowska 231, 00-416, Warsaw, Poland.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Binda', 'Affiliation': 'Department of General, Oncological and Digestive Tract Surgery, Centre of Postgraduate Medical Education, Orłowski Hospital, Czerniakowska 231, 00-416, Warsaw, Poland.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Jaworski', 'Affiliation': 'Department of General, Oncological and Digestive Tract Surgery, Centre of Postgraduate Medical Education, Orłowski Hospital, Czerniakowska 231, 00-416, Warsaw, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Wrzosek', 'Affiliation': 'Department of Biochemistry and Pharmacogenomics, Faculty of Pharmacy, Medical University of Warsaw, Banacha 1, 02-097, Warsaw, Poland.'}, {'ForeName': 'Wiesław', 'Initials': 'W', 'LastName': 'Tarnowski', 'Affiliation': 'Department of General, Oncological and Digestive Tract Surgery, Centre of Postgraduate Medical Education, Orłowski Hospital, Czerniakowska 231, 00-416, Warsaw, Poland.'}]",Obesity surgery,['10.1007/s11695-020-04766-z']
2727,32557443,[PFLEGEprevent - A Randomized Controlled Intervention Study on the Effectiveness of a Prevention Program on Caregiver Workload].,"BACKGROUND


Care staff in Germany is being increasingly affected by physical and mental stress, which is reflected in high number of sick days and early retirement rates. A prevention program that addresses the specific needs of caregivers - strengthening their resources in dealing with workloads and daily challenges- was developed in the project PFLEGEprevent. The prevention program was implemented in an RCT and its effects on stress, work ability and quality of life were evaluated.
METHOD


The randomized controlled intervention study was conducted with 6 survey periods over 9 months. Targeted data were collected using validated tools: Perceived Stress Questionnaire (PSQ), Perceived Stress Scale (PSS), Work Ability Index (WAI), Recovery-Load Questionnaire for work (EBF-Work 27), Short Form-Health Survey (SF-12) and WHO-Five Well-Being Index (WHO-5). Descriptive analyses and the t-test for independent samples to compare changes in primary and secondary outcomes between study groups were conducted.
RESULTS


A total of 125 (92% female, average age 46.7 years) caregivers participated in the study. There were significant group differences in changes of the target size to the follow-up measures up to 9 months. Especially stress was reduced in the long term in the intervention group. Overall well-being in this group improved significantly from baseline to follow-up.
CONCLUSION


The evaluation of the prevention program showed a positive effect in the measured outcome of perceived stress. In other outcomes, significant group differences could be shown after 1 and 3 months.",2020,There were significant group differences in changes of the target size to the follow-up measures up to 9 months.,"['A total of 125 (92% female, average age 46.7 years) caregivers participated in the study']",['Prevention Program'],"['Stress Questionnaire (PSQ), Perceived Stress Scale (PSS), Work Ability Index (WAI), Recovery-Load Questionnaire for work (EBF-Work 27), Short Form-Health Survey (SF-12) and WHO-Five Well-Being Index (WHO-5', 'stress, work ability and quality of life']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0427311,There were significant group differences in changes of the target size to the follow-up measures up to 9 months.,"[{'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Ehegartner', 'Affiliation': 'Medizinische Fakultät, Lehrstuhl für Public Health und Versorgungsforschung - IBE, Ludwig-Maximilians-Universität München, München.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Kirschneck', 'Affiliation': 'Pettenkofer School of Public Health, Ludwig-Maximilians-Universität München, München.'}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Wilhelm', 'Affiliation': 'Psychotraumatologie, BG Klinik für Berufskrankheiten, Bad Reichenhall gGmbH, Bad Reichenhall.'}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Frisch', 'Affiliation': 'Pettenkofer School of Public Health, Ludwig-Maximilians-Universität München, München.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Schuh', 'Affiliation': 'Pettenkofer School of Public Health, Ludwig-Maximilians-Universität München, München.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Kus', 'Affiliation': 'Medizinische Fakultät, Lehrstuhl für Public Health und Versorgungsforschung - IBE, Ludwig-Maximilians-Universität München, München.'}]",Gesundheitswesen (Bundesverband der Arzte des Offentlichen Gesundheitsdienstes (Germany)),['10.1055/a-1160-5624']
2728,32557475,Educational nurse-led telephone intervention shortly before colonoscopy as a salvage strategy after previous bowel preparation failure: a multicenter randomized trial.,"BACKGROUND


The most important predictor of unsuccessful bowel preparation is previous failure. For those patients with previous failure, we hypothesized that a nurse-led educational intervention by telephone shortly before the colonoscopy appointment could improve cleansing efficacy.
METHODS


We performed a multicenter, endoscopist-blinded, randomized controlled trial. Consecutive outpatients with previous inadequate bowel preparation were enrolled. Both groups received the same standard bowel preparation protocol. The intervention group also received reinforced education by telephone within 48 hours before the colonoscopy. The primary outcome was effective bowel preparation according to the Boston Bowel Preparation Scale. Intention-to-treat (ITT) analysis included all randomized patients. Per-protocol analysis included patients who could be contacted by telephone and the control cases.
RESULTS


657 participants were recruited by 11 Spanish hospitals. In the ITT analysis, there was no significant difference between the intervention and control groups in the rate of successful bowel preparation (77.3 % vs. 72 %;  P  = 0.12). In the intervention group, 267 patients (82.9 %) were contacted by telephone. Per-protocol analysis revealed significantly improved bowel preparation in the intervention group (83.5 % vs. 72.0 %;  P  = 0.001).
CONCLUSION


Among all patients with previous inadequate bowel preparation, nurse-led telephone education did not result in a significant improvement in bowel cleansing. However, in the 83 % of patients who could be contacted, bowel preparation was substantially improved. Phone education may therefore be a useful tool for improving the quality of bowel preparation in those cases.",2020,"In the ITT analysis, there was no significant difference between the intervention and control groups in the rate of successful bowel preparation (77.3 % vs. 72 %;  P  = 0.12).","['patients who could be contacted by telephone and the control cases', 'Consecutive outpatients with previous inadequate bowel preparation were enrolled', '657 participants were recruited by 11 Spanish hospitals']","['Educational nurse-led telephone intervention shortly before colonoscopy', 'reinforced education by telephone', 'Intention-to-treat (ITT']","['bowel cleansing', 'rate of successful bowel preparation', 'effective bowel preparation according to the Boston Bowel Preparation Scale', 'bowel preparation', 'cleansing efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1446338', 'cui_str': 'Inadequate bowel preparation'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}]","[{'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C4302285', 'cui_str': 'BBPS - Boston bowel preparation scale'}]",657.0,0.27856,"In the ITT analysis, there was no significant difference between the intervention and control groups in the rate of successful bowel preparation (77.3 % vs. 72 %;  P  = 0.12).","[{'ForeName': 'Marco Antonio', 'Initials': 'MA', 'LastName': 'Alvarez-Gonzalez', 'Affiliation': 'Department of Digestive Diseases, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Pantaleón Sánchez', 'Affiliation': 'Department of Digestive Diseases, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Bernad Cabredo', 'Affiliation': 'Department of Digestive Diseases, Hospital Universitario de Burgos, Burgos, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'García-Rodríguez', 'Affiliation': 'Department of Digestive Diseases, Hospital de Viladecans, Barcelona, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Frago Larramona', 'Affiliation': 'Department of Digestive Diseases, Hospital Santa Bárbara, Soria, Spain.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Nogales', 'Affiliation': 'Department of Digestive Diseases, Hospital Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Díez Redondo', 'Affiliation': 'Department of Digestive Diseases, Hospital del Rio Hortega, Valladolid, Spain.'}, {'ForeName': 'Ignasi', 'Initials': 'I', 'LastName': 'Puig Del Castillo', 'Affiliation': 'Department of Digestive Diseases, Altahia Xarxa Asistencial Universitaria de Manresa, Barcelona, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Romero Mascarell', 'Affiliation': 'Department of Digestive Diseases, Consorci Sanitari de Terrassa, Barcelona, Spain.'}, {'ForeName': 'Noemí', 'Initials': 'N', 'LastName': 'Caballero', 'Affiliation': 'Department of Digestive Diseases, Hospital Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Romero Sánchez-Miguel', 'Affiliation': 'Department of Digestive Diseases, Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Pérez Berbegal', 'Affiliation': 'Department of Digestive Diseases, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Domingo', 'Initials': 'D', 'LastName': 'Hernández Negrín', 'Affiliation': 'Department of Digestive Diseases, Hospital Universitario de Canarias, La Laguna, Spain.'}, {'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Bujedo Sadornill', 'Affiliation': 'Department of Digestive Diseases, Hospital Universitario de Burgos, Burgos, Spain.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Pérez Oltra', 'Affiliation': 'Department of Digestive Diseases, Hospital de Viladecans, Barcelona, Spain.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Casals Urquiza', 'Affiliation': 'Department of Digestive Diseases, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Jaume', 'Initials': 'J', 'LastName': 'Amorós Martínez', 'Affiliation': 'Open University of Catalonia, Barcelona, Spain.'}, {'ForeName': 'Agustín', 'Initials': 'A', 'LastName': 'Seoane Urgorri', 'Affiliation': 'Department of Digestive Diseases, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Inés Ana', 'Initials': 'IA', 'LastName': 'Ibáñez Zafón', 'Affiliation': 'Department of Digestive Diseases, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Antonio Z', 'Initials': 'AZ', 'LastName': 'Gimeno-García', 'Affiliation': 'Department of Digestive Diseases, Hospital Universitario de Canarias, La Laguna, Spain.'}]",Endoscopy,['10.1055/a-1178-9844']
2729,32556156,Vision-Related Functioning in Patients Undergoing Pneumatic Retinopexy vs Vitrectomy for Primary Rhegmatogenous Retinal Detachment: A Post Hoc Exploratory Analysis of the PIVOT Randomized Clinical Trial.,"Importance


Although rhegmatogenous retinal detachment (RRD) repair techniques have high anatomical reattachment rates, there may be differences in various aspects of postoperative vision-related quality of life (VRQoL).
Objective


To explore the differences in various aspects of VRQoL between pneumatic retinopexy (PnR) and pars plana vitrectomy (PPV) following RRD repair.
Design, Setting, and Participants


Post hoc exploratory analysis of the the Pneumatic Retinopexy vs Vitrectomy for the Management of Primary Rhegmatogenous Retinal Detachment Outcomes randomized clinical trial conducted between August 2012 and May 2017 at St Michael's Hospital, Toronto, Ontario, Canada. Patients with RRD with a single break or multiple breaks within 1 clock hour of detached retina in the superior 8 clock hours of the retina with any number, location, and size of retinal breaks or lattice degeneration in attached retina.
Main Outcomes and Measures


Differences in the 25-Item National Eye Institute Visual Function Questionnaire 12 subscale scores between the PnR and PPV groups at 6 months following RRD repair.
Results


A total of 160 patients were included in this analysis, with 81 patients (92%) and 79 patients (90%) in the PnR and PPV groups, respectively. The PnR group consisted of 32% women with a mean (SD) age of 60.9 (9.3) years, while the PPV group consisted of 38% women with a mean (SD) age of 60.3 (7.6) years. For the 152 patients with 6-month follow-up (75 patients in PnR [85%] and 77 patients in PPV [88%]), there was evidence for an association of PnR with superior vision-related functioning compared with PPV for several subscales. There were no differences between groups at 1 year. After adjusting for age, sex, baseline macular status, visual acuity in the nonstudy eye, and lens status, patients who underwent PnR had higher scores for distance activities (mean [SD] PnR, 88.7 [13.4]; PPV, 82.8 [17.1]; adjusted difference, 6.5; 95% CI, 1.6-11.4; P = .01), mental health (mean [SD] PnR, 84.3 [17.4]; PPV, 78.7 [21.1]; adjusted difference, 6.7; 95% CI, 0.4-13; P = .04), dependency (mean [SD] PnR, 96.1 [10.1]; PPV, 91.1 [18.6]; adjusted difference, 5.7; 95% CI, 0.6-10.8; P = .03), and peripheral vision (mean [SD] PnR, 91.6 [16.2]; PPV, 81.2 [24.4]; adjusted difference, 10.8; 95% CI, 4.3-17.4; P = .001) at 6 months.
Conclusions and Relevance


These findings demonstrate that patients undergoing PnR for RRD report higher mental health scores and superior vision-related functioning scores in several subscales of the 25-Item National Eye Institute Visual Function Questionnaire during the first 6 months postoperatively compared with PPV.
Trial Registration


ClinicalTrials.gov Identifier: NCT01639209.",2020,"These findings demonstrate that patients undergoing PnR for RRD report higher mental health scores and superior vision-related functioning scores in several subscales of the 25-Item National Eye Institute Visual Function Questionnaire during the first 6 months postoperatively compared with PPV.
","['Primary Rhegmatogenous Retinal Detachment', ""Primary Rhegmatogenous Retinal Detachment Outcomes randomized clinical trial conducted between August 2012 and May 2017 at St Michael's Hospital, Toronto, Ontario, Canada"", 'The PnR group consisted of 32% women with a mean (SD) age of 60.9 (9.3) years, while the PPV group consisted of 38% women with a mean (SD) age of 60.3 (7.6) years', 'Patients with RRD', 'Patients Undergoing', '160 patients were included in this analysis, with 81 patients (92%) and 79 patients (90%) in the PnR and PPV groups, respectively']","['Pneumatic Retinopexy vs Vitrectomy', 'rhegmatogenous retinal detachment (RRD) repair techniques', 'pneumatic retinopexy (PnR) and pars plana vitrectomy (PPV']","['mental health scores and superior vision-related functioning scores', '25-Item National Eye Institute Visual Function Questionnaire 12 subscale scores', '25-Item National Eye Institute Visual Function Questionnaire', 'peripheral vision', 'mental health', 'distance activities']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0271055', 'cui_str': 'Rhegmatogenous retinal detachment'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0395578', 'cui_str': 'Pneumatic retinopexy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0395578', 'cui_str': 'Pneumatic retinopexy'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0271055', 'cui_str': 'Rhegmatogenous retinal detachment'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C1955969', 'cui_str': 'National Eye Institute'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0234628', 'cui_str': 'Peripheral vision'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",160.0,0.412786,"These findings demonstrate that patients undergoing PnR for RRD report higher mental health scores and superior vision-related functioning scores in several subscales of the 25-Item National Eye Institute Visual Function Questionnaire during the first 6 months postoperatively compared with PPV.
","[{'ForeName': 'Rajeev H', 'Initials': 'RH', 'LastName': 'Muni', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Carolina L M', 'Initials': 'CLM', 'LastName': 'Francisconi', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Felfeli', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Michael Y K', 'Initials': 'MYK', 'LastName': 'Mak', 'Affiliation': 'Division of Ophthalmology, Department of Surgery, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Alan R', 'Initials': 'AR', 'LastName': 'Berger', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Wong', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Filiberto', 'Initials': 'F', 'LastName': 'Altomare', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Louis R', 'Initials': 'LR', 'LastName': 'Giavedoni', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Radha P', 'Initials': 'RP', 'LastName': 'Kohly', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Kertes', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Figueiredo', 'Affiliation': ""St Michael's Hospital, Department of Ophthalmology, Unity Health Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zuo', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Thorpe', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Roxane J', 'Initials': 'RJ', 'LastName': 'Hillier', 'Affiliation': 'Newcastle Eye Centre, Royal Victoria Infirmary, Newcastle upon Tyne, England.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.2007']
2730,32556157,Entecavir Plus Pegylated Interferon and Sequential HBV Vaccination Increases HBsAg Seroclearance: A Randomized Controlled Proof-of-Concept Study.,"BACKGROUND


HBsAg seroclearance is considered a functional cure for patients with chronic hepatitis B, but is rarely achievable with oral nucleos(t)ide analogs alone. We conducted a randomized controlled proof-of-concept trial to evaluate the impact of adding pegylated interferon (Peg-IFN) alfa-2a plus sequential or concomitant hepatitis B virus (HBV) vaccination.
METHODS


A total of 111 patients who achieved serum HBV DNA <20 IU/mL and quantitated HBsAg (qHBsAg) <3,000 IU/mL with entecavir were randomly assigned (1:1:1) to the E+sVIP group (entecavir + Peg-IFN alfa-2a [180 µg every week over 48 weeks] + sequential HBV vaccination [20 µg of HBsAg on weeks 52, 56, 60, and 76]), E+cVIP group (entecavir + Peg-IFN alfa-2a + concomitant HBV vaccination [weeks 4, 8, 12, and 28]), or the control group (entecavir only). The primary endpoint was HBsAg seroclearance at week 100 and secondary endpoints included safety.
RESULTS


No differences in baseline qHBsAg were observed among the groups. The E+sVIP group in the intention-to-treat analysis showed a significantly higher chance of HBsAg seroclearance during week 100 than the control group (16.2% vs. 0%, P=0.025), but the E+cVIP group (5.4%) failed to reach a significant difference (P=0.54). Adverse events were significantly more frequent in the E+sVIP (81.1%) or E+cVIP group (70.3%) than the control group (2.7%) (both P<0.0001). However, the frequency of serious adverse events did not differ significantly among three groups (2.7%, 5.4%, and 2.7%, respectively; P=1.00).
CONCLUSIONS


Entecavir plus an additional Peg-IFN alfa-2a treatment followed by sequential HBV vaccination under an intensified schedule significantly increases the chance of HBsAg seroclearance compared to entecavir alone.",2020,Adverse events were significantly more frequent in the E+sVIP (81.1%) or E+cVIP group (70.3%) than the control group (2.7%) (both P<0.0001).,"['patients with chronic hepatitis B', 'A total of 111 patients who achieved serum HBV DNA <20 IU/mL and quantitated HBsAg (qHBsAg', 'HBsAg Seroclearance']","['E+cVIP group (entecavir + Peg-IFN alfa-2a + concomitant HBV vaccination', 'E+sVIP', 'control group (entecavir', 'pegylated interferon (Peg-IFN) alfa-2a plus sequential or concomitant hepatitis B virus (HBV) vaccination', 'Entecavir Plus Pegylated Interferon and Sequential HBV', 'E+sVIP group (entecavir + Peg-IFN alfa-2a [180 µg every week over 48 weeks] + sequential HBV vaccination', 'E+cVIP']","['HBsAg seroclearance', 'Adverse events', 'frequency of serious adverse events', 'safety', 'chance of HBsAg seroclearance', 'baseline qHBsAg']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0019378', 'cui_str': 'Cercopithecine herpesvirus 1'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0439458', 'cui_str': 'IU/mL'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C0021734', 'cui_str': 'Interferon Alfa-2a'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",111.0,0.0779048,Adverse events were significantly more frequent in the E+sVIP (81.1%) or E+cVIP group (70.3%) than the control group (2.7%) (both P<0.0001).,"[{'ForeName': 'Jeong-Hoon', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yun Bin', 'Initials': 'YB', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Eun Ju', 'Initials': 'EJ', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Su Jong', 'Initials': 'SJ', 'LastName': 'Yu', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jung-Hwan', 'Initials': 'JH', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yoon Jun', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa807']
2731,32556176,"A double-blind randomized phase 2 controlled trial of intradermal hepatitis B vaccination with a topical Toll-like receptor 7 agonist imiquimod, in patients on dialysis.","BACKGROUND


Patients on dialysis are hyporesponsive to the current hepatitis B virus vaccines (HBVv). We conducted a phase-2 trial examining four-doses of intradermal (ID) HBVv Sci-B-Vac™, with topical TLR7 agonist imiquimod pretreatment in dialysis patients.
METHODS


In this double-blind, randomized-controlled trial, we enrolled and prospectively followed adult patients on dialysis between January 2016 and September 2018. Eligible patients were randomly allocated (1:1:1) into one treatment: topical imiquimod-cream followed by intradermal HBVv (IMQ_ID), and two control groups: topical aqueous-cream (placebo) followed by ID HBVv (AQ_ID) or topical aqueous-cream followed by intramuscular (IM) HBVv (AQ_IM). The primary end-point was the seroprotection rate (anti-HBs≥10mIU/mL) at 52 weeks after the first dose of HBVv.
RESULTS


Ninety-four patients on dialysis were enrolled, among which 57.4% were previous non-responders. The primary outcome of seroprotection rate was significantly better at week 52 for the treatment group (IMQ_ID) with 96.9% seroprotection rate, comparing compared to 74.2% and 48.4% for the AQ_ID and AQ_IM groups, respectively (p<0.0001). The GMC was also significantly higher at week 52 for the IMQ_ID group of 1135 mIU/mL (95% CI, 579.4-2218.2 mIU/mL), compared to 86.9 mIU/mL (95% CI, 18.5-409.3 mIU/mL) and 7.2 mIU/mL (2.0-26.5mIU/mL) for the AQ_ID and AQ_IM groups, respectively (p<0.0001). IMQ_ID vaccination [OR, 3.70 (95% CI, 1.16-11.81;p=0.027) was the only factor independently associated with higher seroprotection rate at 52 weeks. Adverse reaction was infrequent.
CONCLUSIONS


Pretreatment with topical imiquimod (TLR7 agonist) before ID HBVv Sci-B-Vac™ was safe with favorable seroprotection and as such potentially improved prevention against HBV infection in dialysis patients.",2020,"OR, 3.70 (95% CI, 1.16-11.81;p=0.027) was the only factor independently associated with higher seroprotection rate at 52 weeks.","['adult patients on dialysis between January 2016 and September 2018', 'Ninety-four patients on dialysis', 'patients on dialysis', 'dialysis patients', 'Eligible patients']","['topical imiquimod-cream followed by intradermal HBVv (IMQ_ID), and two control groups: topical aqueous-cream (placebo) followed by ID HBVv (AQ_ID) or topical aqueous-cream followed by intramuscular (IM) HBVv (AQ_IM', 'intradermal hepatitis B vaccination with a topical Toll-like receptor 7 agonist imiquimod', 'topical imiquimod (TLR7 agonist', 'intradermal (ID) HBVv Sci-B-Vac™, with topical TLR7 agonist imiquimod']","['Adverse reaction', 'seroprotection rate', 'IMQ_ID vaccination ']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C1252977', 'cui_str': 'imiquimod Topical Cream'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0062527', 'cui_str': 'Hepatitis B Surface Antigen Vaccine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0474232', 'cui_str': 'Hepatitis B vaccination'}, {'cui': 'C0971207', 'cui_str': 'TLR7 protein, human'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0165032', 'cui_str': 'imiquimod'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C1252977', 'cui_str': 'imiquimod Topical Cream'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",,0.309606,"OR, 3.70 (95% CI, 1.16-11.81;p=0.027) was the only factor independently associated with higher seroprotection rate at 52 weeks.","[{'ForeName': 'Ivan Fan-Ngai', 'Initials': 'IF', 'LastName': 'Hung', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, the University of Hong Kong, Queen Mary Hospital, Pokfulam, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Desmond Yat-Hin', 'Initials': 'DY', 'LastName': 'Yap', 'Affiliation': 'Division of Nephrology, Department of Medicine, the University of Hong Kong, Queen Mary Hospital, Pokfulam, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Terence Pok-Siu', 'Initials': 'TP', 'LastName': 'Yip', 'Affiliation': 'Division of Nephrology, Department of Medicine, Tung Wah Hospital, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Ricky Ruiqi', 'Initials': 'RR', 'LastName': 'Zhang', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, the University of Hong Kong, Queen Mary Hospital, Pokfulam, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Kelvin Kai-Wang', 'Initials': 'KK', 'LastName': 'To', 'Affiliation': ""Carol Yu's Centre for Infection and Division of Infectious Diseases, the University of Hong Kong, Queen Mary Hospital, Pokfulam, Hong Kong Special Administrative Region, China.""}, {'ForeName': 'Kwok-Hung', 'Initials': 'KH', 'LastName': 'Chan', 'Affiliation': ""Carol Yu's Centre for Infection and Division of Infectious Diseases, the University of Hong Kong, Queen Mary Hospital, Pokfulam, Hong Kong Special Administrative Region, China.""}, {'ForeName': 'Sydney Chi-Wai', 'Initials': 'SC', 'LastName': 'Tang', 'Affiliation': 'Division of Nephrology, Department of Medicine, the University of Hong Kong, Queen Mary Hospital, Pokfulam, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Sing-Leung', 'Initials': 'SL', 'LastName': 'Lui', 'Affiliation': 'Division of Nephrology, Department of Medicine, Tung Wah Hospital, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Yotam', 'Initials': 'Y', 'LastName': 'Levin', 'Affiliation': 'NanoPass Technologies, Nes Ziona, Israel.'}, {'ForeName': 'Efrat', 'Initials': 'E', 'LastName': 'Kochba', 'Affiliation': 'NanoPass Technologies, Nes Ziona, Israel.'}, {'ForeName': 'Johnson Yiu-Nam', 'Initials': 'JY', 'LastName': 'Lau', 'Affiliation': ""Carol Yu's Centre for Infection and Division of Infectious Diseases, the University of Hong Kong, Queen Mary Hospital, Pokfulam, Hong Kong Special Administrative Region, China.""}, {'ForeName': 'Man-Fung', 'Initials': 'MF', 'LastName': 'Yuen', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, the University of Hong Kong, Queen Mary Hospital, Pokfulam, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Tak-Mao', 'Initials': 'TM', 'LastName': 'Chan', 'Affiliation': 'Division of Nephrology, Department of Medicine, the University of Hong Kong, Queen Mary Hospital, Pokfulam, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Kwok-Yung', 'Initials': 'KY', 'LastName': 'Yuen', 'Affiliation': ""Carol Yu's Centre for Infection and Division of Infectious Diseases, the University of Hong Kong, Queen Mary Hospital, Pokfulam, Hong Kong Special Administrative Region, China.""}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa804']
2732,32556194,Indirect effect of oral azithromycin on the gut resistome of untreated children: a randomized controlled trial.,"BACKGROUND


Antibiotic use by one individual may affect selection for antimicrobial resistance in close contacts. Here we evaluated whether oral antibiotic treatment of one child within a household affected the gut resistome of an untreated cohabiting child.
METHODS


Households with at least two children <5 y of age were randomized in a 1:1 fashion to a 5d course of azithromycin or placebo. To evaluate indirect effects of azithromycin treatment on the gut resistome, we randomly assigned one child in the house to azithromycin and one to placebo. In placebo households, each child received placebo. We performed DNA sequencing of rectal swabs collected 5 d after the last antibiotic dose. We estimated risk ratios for the presence of genetic resistance determinants at the class level using modified Poisson models for children in azithromycin households compared with placebo households and assessed the composition of the resistome using permutational analysis of variance (PERMANOVA).
RESULTS


Of 58 children (n = 30 azithromycin households, n = 28 placebo households) with post-treatment rectal swabs, genetic resistance determinants were common but there was no significant difference at the class (p = 0.54 for macrolides) or gene (p = 0.94 for structure by PERMANOVA, p = 0.94 for diversity) level between untreated children in azithromycin households compared with placebo households.
CONCLUSIONS


The results are encouraging that one child's antibiotic use may not influence the resistome of another child. Trial registration: ClinicalTrials.gov NCT03187834.",2020,"RESULTS


Of 58 children (n = 30 azithromycin households, n = 28 placebo households) with post-treatment rectal swabs, genetic resistance determinants were common but there was no significant difference at the class (p = 0.54 for macrolides) or gene (p = 0.94 for structure by PERMANOVA, p = 0.94 for diversity) level between untreated children in azithromycin households compared with placebo households.
","['one child within a household affected the gut resistome of an untreated cohabiting child', 'untreated children', 'Households with at least two children', '58 children (n = 30']","['placebo', 'azithromycin', 'azithromycin or placebo', 'oral azithromycin']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0221179', 'cui_str': 'Cohabiting'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]",[],58.0,0.445207,"RESULTS


Of 58 children (n = 30 azithromycin households, n = 28 placebo households) with post-treatment rectal swabs, genetic resistance determinants were common but there was no significant difference at the class (p = 0.54 for macrolides) or gene (p = 0.94 for structure by PERMANOVA, p = 0.94 for diversity) level between untreated children in azithromycin households compared with placebo households.
","[{'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Francis I Proctor Foundation, 513 Parnassus Avenue, University of California, San Francisco, San Francisco, CA 94143, USA.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Hinterwirth', 'Affiliation': 'Francis I Proctor Foundation, 513 Parnassus Avenue, University of California, San Francisco, San Francisco, CA 94143, USA.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Worden', 'Affiliation': 'Francis I Proctor Foundation, 513 Parnassus Avenue, University of California, San Francisco, San Francisco, CA 94143, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Sié', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Rue Namory Keita, Nouna, Burkina Faso.'}, {'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Dah', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Rue Namory Keita, Nouna, Burkina Faso.'}, {'ForeName': 'Lucienne', 'Initials': 'L', 'LastName': 'Ouermi', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Rue Namory Keita, Nouna, Burkina Faso.'}, {'ForeName': 'Boubacar', 'Initials': 'B', 'LastName': 'Coulibaly', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Rue Namory Keita, Nouna, Burkina Faso.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': 'Francis I Proctor Foundation, 513 Parnassus Avenue, University of California, San Francisco, San Francisco, CA 94143, USA.'}, {'ForeName': 'Cindi', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Francis I Proctor Foundation, 513 Parnassus Avenue, University of California, San Francisco, San Francisco, CA 94143, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Ruder', 'Affiliation': 'Francis I Proctor Foundation, 513 Parnassus Avenue, University of California, San Francisco, San Francisco, CA 94143, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I Proctor Foundation, 513 Parnassus Avenue, University of California, San Francisco, San Francisco, CA 94143, USA.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I Proctor Foundation, 513 Parnassus Avenue, University of California, San Francisco, San Francisco, CA 94143, USA.'}, {'ForeName': 'Thuy', 'Initials': 'T', 'LastName': 'Doan', 'Affiliation': 'Francis I Proctor Foundation, 513 Parnassus Avenue, University of California, San Francisco, San Francisco, CA 94143, USA.'}]",International health,['10.1093/inthealth/ihaa029']
2733,32556354,"Efficacy of radial extracorporeal shock wave therapy compared with botulinum toxin type A injection in treatment of lower extremity spasticity in subjects with cerebral palsy: A randomized, controlled, cross-over study.","OBJECTIVES


To investigate whether botulinum toxin type A (BTX-A) injection is more effective than radial extracorporeal shock wave therapy in reducing plantar flexor muscle spasticity in subjects with cerebral palsy.
METHODS


A total of 68 subjects with cerebral palsy were randomly allocated to BTX-A injection (Group 1) or radial extracorporeal shock wave therapy (Group 2) (first experiment; E1). Outcome was evaluated using the Tardieu V1 and V3 stretches, at 3 weeks, 2 months (M2) and M3 after baseline. At M6 subjects in Group 1 received radial extracorporeal shock wave therapy and subjects in Group 2 received BTX-A injection (second experiment; E2); outcome was evaluated as in E1. Treatment success was defined as improvement in foot dorsiflexion ≥10° when performing the V3 stretch at M2 in both experiments.
RESULTS


In both experiments mean V1 and V3 significantly improved over time. In E1 both treatments resulted in similar treatment success. In E2 fewer subjects treated with BTX-A injection reached the criteria of treatment success than did subjects treated with radial extracorporeal shock wave therapy, which was due to a carry-over effect from E1. No significant complications were observed.
CONCLUSION


BTX-A injection is not superior to radial extracorporeal shock wave therapy in the treatment of plantar flexor muscle spasticity in subjects with cerebral palsy.",2020,BTX-A injection is not superior to radial extracorporeal shock wave therapy in the treatment of plantar flexor muscle spasticity in subjects with cerebral palsy.,"['subjects with cerebral palsy', '68 subjects with cerebral palsy']","['BTX-A injection (Group 1) or radial extracorporeal shock wave therapy', 'radial extracorporeal shock wave therapy', 'botulinum toxin type', 'BTX-A injection', 'botulinum toxin type A (BTX-A) injection']",['plantar flexor muscle spasticity'],"[{'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}]","[{'cui': 'C4060200', 'cui_str': 'Botulinum Toxin Type A Injection [Botox]'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}]",68.0,0.0388298,BTX-A injection is not superior to radial extracorporeal shock wave therapy in the treatment of plantar flexor muscle spasticity in subjects with cerebral palsy.,"[{'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Vidal', 'Affiliation': 'Blanquerna School of Health Science, Ramon Llull University, Barcelona, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Martí-Fàbregas', 'Affiliation': ''}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Canet', 'Affiliation': ''}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Roqué', 'Affiliation': ''}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Morral', 'Affiliation': ''}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Tur', 'Affiliation': ''}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Schmitz', 'Affiliation': ''}, {'ForeName': 'Mercè', 'Initials': 'M', 'LastName': 'Sitjà-Rabert', 'Affiliation': ''}]",Journal of rehabilitation medicine,['10.2340/16501977-2703']
2734,32556356,Erratum: Efficacy and Safety of Oral Administration of a Mixture of Probiotic Strains in Patients with Psoriasis: A Randomized Controlled Clinical Trial.,,2020,,['Patients with Psoriasis'],['Oral Administration of a Mixture of Probiotic Strains'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C0001563', 'cui_str': 'Medication administration: oral'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}]",[],,0.0730396,,[],Acta dermato-venereologica,['10.2340/00015555-3529']
2735,32557180,"The Effect of Positively Framing Side-Effect Risk in Two Different Formats on Side-Effect Expectations, Informed Consent and Credibility: A Randomised Trial of 16- to 75-Year-Olds in England.","INTRODUCTION


Reframing side-effect information in patient information leaflets (PILs) in terms of those who remain side-effect-free may reduce negative expectations and side-effects, although there are concerns this may impact informed consent. This study compared two versions of positively framed PILs with current practice to see which reduces side-effect expectations whilst maintaining informed consent and credibility.
METHODS


We commissioned Ipsos MORI to conduct an online survey of 16- to 75-year-olds in England. 1067 people completed the study and were randomised to receive a PIL for a hypothetical new antibiotic that either communicated side-effects following current practice (n = 356), used positive framing with natural frequencies (n = 356), or positive framing with percentages (n = 355). After reading the leaflet, participants completed measures of their side-effect expectations, absolute risk perceptions, and satisfaction and credibility of the leaflet.
RESULTS


Both positively framed PILs resulted in significantly lower side-effect expectations compared with the current PIL for all side-effects (ps < 0.001), apart from seizure. Pairwise comparisons showed no difference in side-effect expectations between the two positively framed PILs (ps > 0.626). The positively framed PIL using natural frequencies produced more accurate risk perceptions than the same leaflet using percentages; but performed equally to the current PIL. There was no difference between the leaflets in terms of satisfaction with or credibility of the PILs.
CONCLUSION


Positively framed PILs using natural frequencies significantly reduced side-effect expectations and provided the most accurate risk perceptions without impacting satisfaction or credibility. Replication is needed with patients prescribed new medication and those with lower educational status.",2020,"Both positively framed PILs resulted in significantly lower side-effect expectations compared with the current PIL for all side-effects (ps < 0.001), apart from seizure.","['16- to 75-Year-Olds in England', '1067 people completed the study']",[],"['side-effect expectations', 'satisfaction with or credibility of the PILs', 'side-effect expectations, absolute risk perceptions, and satisfaction and credibility of the leaflet', 'accurate risk perceptions']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",1067.0,0.0810552,"Both positively framed PILs resulted in significantly lower side-effect expectations compared with the current PIL for all side-effects (ps < 0.001), apart from seizure.","[{'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Webster', 'Affiliation': 'Department of Psychology, University of Sheffield, Cathedral Court, 1 Vicar Lane, Sheffield, UK. r.k.webster@sheffield.ac.uk.'}, {'ForeName': 'G James', 'Initials': 'GJ', 'LastName': 'Rubin', 'Affiliation': ""Department of Psychological Medicine, King's College London, Institute of Psychiatry, Psychology and Neuroscience, Weston Education Centre, Denmark Hill, London, UK.""}]",Drug safety,['10.1007/s40264-020-00959-8']
2736,32557211,Breast cancer survivors living with chronic neuropathic pain show improved brain health following mindfulness-based stress reduction: a preliminary diffusion tensor imaging study.,"PURPOSE


The present study explores the benefits of an 8-week mindfulness-based stress reduction (MBSR) program to white matter integrity among breast cancer survivors experiencing chronic neuropathic pain (CNP).
METHODS


Twenty-three women were randomly assigned to either a MBSR treatment group (n = 13) or a waitlist control group (n = 10). Participants were imaged with MRI prior to and post-MBSR training using diffusion tensor imaging.
RESULTS


Compared with controls, the MBSR group showed a significant increase in fractional anisotropy (FA), particularly in the left subcortical regions including the uncinate fasciculus, amygdala, and hippocampus, as well as in the external capsule and in the left sagittal stratum. No decreases to FA were found in any brain regions following MBSR training. The FA values also negatively correlated with the pain severity and pain interference scores from the BRIEF pain questionnaire.
CONCLUSIONS


The present findings demonstrate that MBSR training may enhance the integrity of cerebral white matter that coincides with a reduction in pain perception. Further research with a larger sample size is required.
IMPLICATIONS FOR CANCER SURVIVORS


This study highlights the potential for MBSR, as a non-pharmacological intervention, to provide both brain health improvement and pain perception relief for female breast cancer survivors experiencing CNP.",2020,"Compared with controls, the MBSR group showed a significant increase in fractional anisotropy (FA), particularly in the left subcortical regions including the uncinate fasciculus, amygdala, and hippocampus, as well as in the external capsule and in the left sagittal stratum.","['Breast cancer survivors living with chronic neuropathic pain', 'Twenty-three women', 'FOR CANCER SURVIVORS', 'breast cancer survivors experiencing chronic neuropathic pain (CNP', 'female breast cancer survivors experiencing CNP']","['8-week mindfulness-based stress reduction (MBSR) program', 'MBSR training', 'MBSR treatment', 'mindfulness-based stress reduction', 'waitlist control group']","['pain severity and pain interference scores', 'pain perception', 'fractional anisotropy (FA', 'FA', 'brain health']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C4544057', 'cui_str': 'Chronic neuropathic pain'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0235653', 'cui_str': 'Malignant neoplasm of female breast'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",23.0,0.0159926,"Compared with controls, the MBSR group showed a significant increase in fractional anisotropy (FA), particularly in the left subcortical regions including the uncinate fasciculus, amygdala, and hippocampus, as well as in the external capsule and in the left sagittal stratum.","[{'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Mioduszewski', 'Affiliation': 'Department of Anesthesiology and Pain Medicine,, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Hatchard', 'Affiliation': 'Department of Anesthesiology and Pain Medicine,, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Fang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine,, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Poulin', 'Affiliation': 'Department of Anesthesiology and Pain Medicine,, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Eve-Ling', 'Initials': 'EL', 'LastName': 'Khoo', 'Affiliation': ""Youth Wellness Centre, St. Joseph's Healthcare Hamilton, Hamilton, Canada.""}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Romanow', 'Affiliation': ""Youth Wellness Centre, St. Joseph's Healthcare Hamilton, Hamilton, Canada.""}, {'ForeName': 'Yaad', 'Initials': 'Y', 'LastName': 'Shergill', 'Affiliation': ""Youth Wellness Centre, St. Joseph's Healthcare Hamilton, Hamilton, Canada.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Tennant', 'Affiliation': ""Youth Wellness Centre, St. Joseph's Healthcare Hamilton, Hamilton, Canada.""}, {'ForeName': 'Maiko A', 'Initials': 'MA', 'LastName': 'Schneider', 'Affiliation': ""Youth Wellness Centre, St. Joseph's Healthcare Hamilton, Hamilton, Canada.""}, {'ForeName': 'Nikisha', 'Initials': 'N', 'LastName': 'Browne', 'Affiliation': ""Youth Wellness Centre, St. Joseph's Healthcare Hamilton, Hamilton, Canada.""}, {'ForeName': 'Andra M', 'Initials': 'AM', 'LastName': 'Smith', 'Affiliation': 'Department of Anesthesiology and Pain Medicine,, University of Ottawa, Ottawa, Ontario, Canada. asmith@uottawa.ca.'}]",Journal of cancer survivorship : research and practice,['10.1007/s11764-020-00903-w']
2737,32557338,Chronic adverse effects after an axillary lymphadenectomy in breast cancer patients after administering weaker and stronger postoperative analgesia: results of a prospective double-blind randomized study.,"PURPOSE


The aim of this study was to compare the rate of chronic adverse effects after a weaker and stronger postoperative analgesia.
METHODS


A prospective double-blind randomized study included 117 breast cancer patients receiving tramadol for pain relief for 4 weeks after an axillary lymphadenectomy from 2015 to 2018. Patients with a larger dose received 75/650 mg of tramadol with paracetamol every 8 h and a group with a lower dose received 37.5/325 mg of tramadol with paracetamol every 8 h from the 2nd to the 29th postoperative day. 1 year after surgery, patients were evaluated for the presence of neuropathic pain, chronic pain, arm symptoms and lymphedema.
RESULTS


There was a trend for a lower rate of neuropathic pain after stronger analgesia in comparison to weaker analgesia (p = 0.059). Chronic pain was present in 18% of patients 1 year after the lymphadenectomy. There was no difference in the rate of chronic pain after stronger and weaker postoperative analgesia. Patients had less arm symptoms after a stronger analgesia than after a weaker analgesia (p = 0.02). Furthermore, there was a trend for a lower rate of lymphedema of the forearm after a stronger analgesia than after a lower analgesia (p = 0.078).
CONCLUSIONS


The patients who received a stronger postoperative analgesia had less arm symptoms and a better quality of life in comparison to patients who received a weaker analgesia. The patients who received a stronger postoperative analgesia had a statistical trend for less neuropathic pain in comparison to patients who received a weaker analgesia.",2020,There was a trend for a lower rate of neuropathic pain after stronger analgesia in comparison to weaker analgesia (p = 0.059).,"['for pain relief for 4\xa0weeks after an axillary lymphadenectomy from 2015 to 2018', 'breast cancer patients after administering weaker and stronger postoperative analgesia', '117 breast cancer patients receiving']","['tramadol with paracetamol', 'tramadol', 'axillary lymphadenectomy']","['rate of chronic adverse effects', 'quality of life', 'Chronic adverse effects', 'Chronic pain', 'rate of chronic pain', 'neuropathic pain, chronic pain, arm symptoms and lymphedema', 'postoperative analgesia', 'neuropathic pain']","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1762617', 'cui_str': 'Weak'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]",117.0,0.401534,There was a trend for a lower rate of neuropathic pain after stronger analgesia in comparison to weaker analgesia (p = 0.059).,"[{'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Besic', 'Affiliation': 'Department of Surgical Oncology, Institute of Oncology, Zaloska 2, 1000, Ljubljana, Slovenia. nbesic@onko-i.si.'}, {'ForeName': 'Jaka', 'Initials': 'J', 'LastName': 'Smrekar', 'Affiliation': 'Faculty of Mathematics and Physics, University of Ljubljana, 1000, Ljubljana, Slovenia.'}, {'ForeName': 'Branka', 'Initials': 'B', 'LastName': 'Strazisar', 'Affiliation': 'Department of Anesthesiology, Institute of Oncology, Zaloska 2, 1000, Ljubljana, Slovenia.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05713-3']
2738,32557346,"Influence of Cow's Milk and Esomeprazole on the Absorption of Erlotinib: A Randomized, Crossover Pharmacokinetic Study in Lung Cancer Patients.","INTRODUCTION


Erlotinib's gastrointestinal solubility and absorption are decreased by proton pump inhibitors (PPIs). Since erlotinib is a lipophilic drug, we hypothesized that concomitant intake with the fatty beverage milk may be a feasible way to increase erlotinib uptake. We performed a two-period, randomized, crossover study to investigate the influence of cow's milk with 3.9% fat on the exposure of erlotinib with and without the PPI esomeprazole in patients with non-small cell lung cancer (NSCLC). The effect of esomeprazole was studied in an additional intrapatient comparison.
METHOD


Pharmacokinetic sampling was performed on days 7 and 14 during 24 consecutive hours. During the 7 days prior to pharmacokinetic sampling, erlotinib was taken daily with 250 mL of either water or milk. In the PPI arm, esomeprazole (40 mg once daily 3 h prior to erlotinib) was taken for 3 days.
RESULTS


Erlotinib area under the curve from time zero to 24 h (AUC 24 ) did not significantly change when administered with milk, compared with water, in both non-PPI users (n = 14; - 3%; 95% confidence interval [CI] - 12 to 8%; p = 0.57) and patients who used esomeprazole (n = 15; 0%; 95% CI - 15 to 17%; p = 0.95). Esomeprazole decreased erlotinib AUC 24  by 47% (n = 9; 95% CI - 57 to - 34%; p < 0.001) and C max  by 56% (95% CI - 64 to - 46%; p < 0.001). No differences in toxicities were observed between milk and water.
CONCLUSION


Milk with 3.9% fat has no effect on the exposure to erlotinib in NSCLC patients, independent of PPI use. The combination with milk is safe and well tolerated. Concomitant esomeprazole treatment strongly decreased both erlotinib AUC 24  and C max  and should be avoided if possible.",2020,Concomitant esomeprazole treatment strongly decreased both erlotinib AUC 24  and C max  and should be avoided if possible.,"['Lung Cancer Patients', 'patients with non-small cell lung cancer (NSCLC']","['erlotinib with and without the PPI esomeprazole', 'esomeprazole', ""Cow's Milk and Esomeprazole"", 'Esomeprazole']","['Absorption of Erlotinib', 'toxicities', 'erlotinib AUC', 'safe and well tolerated']","[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0937846', 'cui_str': 'Esomeprazole'}, {'cui': 'C0349374', 'cui_str': ""Cow's milk""}]","[{'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",,0.0290052,Concomitant esomeprazole treatment strongly decreased both erlotinib AUC 24  and C max  and should be avoided if possible.,"[{'ForeName': 'G D Marijn', 'Initials': 'GDM', 'LastName': 'Veerman', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Erasmus University Medical Center, Dr. Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands. g.veerman@erasmusmc.nl.'}, {'ForeName': 'Koen G A M', 'Initials': 'KGAM', 'LastName': 'Hussaarts', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Erasmus University Medical Center, Dr. Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Peric', 'Affiliation': 'Department of Pulmonology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Oomen-de Hoop', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Erasmus University Medical Center, Dr. Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.'}, {'ForeName': 'Kersten D', 'Initials': 'KD', 'LastName': 'Landa', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Erasmus University Medical Center, Dr. Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.'}, {'ForeName': 'Cor H', 'Initials': 'CH', 'LastName': 'van der Leest', 'Affiliation': 'Department of Pulmonology, Amphia Hospital, Breda, The Netherlands.'}, {'ForeName': 'Suzanna D', 'Initials': 'SD', 'LastName': 'Broerse', 'Affiliation': 'Department of Pulmonology, Franciscus Gasthuis and Vlietland Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Hugo B', 'Initials': 'HB', 'LastName': 'Rutten', 'Affiliation': 'Department of Pulmonology, Bravis Hospital, Roosendaal and Bergen op Zoom, The Netherlands.'}, {'ForeName': 'Huub N A', 'Initials': 'HNA', 'LastName': 'Belderbos', 'Affiliation': 'Department of Pulmonology, Amphia Hospital, Breda, The Netherlands.'}, {'ForeName': 'Christi M J', 'Initials': 'CMJ', 'LastName': 'Steendam', 'Affiliation': 'Department of Pulmonology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Marthe S', 'Initials': 'MS', 'LastName': 'Paats', 'Affiliation': 'Department of Pulmonology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Stijn L W', 'Initials': 'SLW', 'LastName': 'Koolen', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Erasmus University Medical Center, Dr. Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.'}, {'ForeName': 'Anne-Marie C', 'Initials': 'AC', 'LastName': 'Dingemans', 'Affiliation': 'Department of Pulmonology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Teun', 'Initials': 'T', 'LastName': 'van Gelder', 'Affiliation': 'Department of Hospital Pharmacy, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Roelof W F', 'Initials': 'RWF', 'LastName': 'van Leeuwen', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Erasmus University Medical Center, Dr. Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.'}, {'ForeName': 'Joachim G J V', 'Initials': 'JGJV', 'LastName': 'Aerts', 'Affiliation': 'Department of Pulmonology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Ron H J', 'Initials': 'RHJ', 'LastName': 'Mathijssen', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Erasmus University Medical Center, Dr. Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.'}]",Clinical pharmacokinetics,['10.1007/s40262-020-00910-1']
2739,32557506,[Therapeutic success of proton pump inhibitors in the therapy of contact granulomas].,"According to the current S2k guideline ""Gastroesophageal Reflux Disease (GERD)"" of 05/2014, an empirical proton pump inhibitor (PPI) therapy in double standard dose (e. g. Pantoprazole 40 mg 2 ×/day) is recommended for the extraesophageal GERD manifestation (e. g. with formation of a contact granuloma, CG) for 8 weeks. However, valid study data don't exist.In a prospective study from 05.2015 to 12.2019 39 patients consecutively randomized with endoscopically proven KG received PPIs in single (1 × PPI, n = 22) or double standard dose (2 × PPI, n = 17) for 8 weeks. A possible gastrolaryngeal reflux as well as throat sensations, a tendency to clear the throat or a hoarseness were recorded at first presentation and at control after 4 months.This was archieved by videolaryngostroboscopy to detect hoarseness and to assess the development of the granuloma (progression, constant, remission < 50 %, > 50 % or complete). The two groups were compared.The granuloma disappeared or regressed in 40 % of the cases with 1 × PPIs and in 77 % of the cases with 2 × PPIs (p < 0.05) after therapy. At the control appointment 23 % of the patients with 1 × PPIs were completely symptom-free and 77 % of the patients with 2 × PPIs. Throat sensation was the most frequent symptom at first presentation with 64 %. In the control group after PPI therapy in single or double standard dose, throat sensations were only detectable in 33 % and 15 % in case of granuloma remission. However, if the granuloma was persistent, the symptoms could hardly be influenced.The therapy of a KG with PPIs in double standard dose is more effective than in single standard dose. These results must be confirmed on a larger collective.",2020,"In the control group after PPI therapy in single or double standard dose, throat sensations were only detectable in 33 % and 15 % in case of granuloma remission.",['05.2015 to 12.2019 39 patients consecutively randomized with endoscopically proven KG received'],"['PPIs', 'Pantoprazole 40', 'proton pump inhibitors', 'proton pump inhibitor (PPI) therapy']","['throat sensations', 'Throat sensation', 'extraesophageal GERD manifestation ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456369', 'cui_str': 'Proven'}]","[{'cui': 'C0081876', 'cui_str': 'pantoprazole'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}]",,0.0366975,"In the control group after PPI therapy in single or double standard dose, throat sensations were only detectable in 33 % and 15 % in case of granuloma remission.","[{'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Heyduck', 'Affiliation': 'Sektion Phoniatrie und Pädaudiologie der Klinik für Hals-Nasen- Ohrenheilkunde, Kopf- und Halschirurgie, Univ.-Klinik Ulm, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Pickhard', 'Affiliation': 'Hals-Nasen-Ohrenklinik, Technische Universität München, Germany.'}, {'ForeName': 'Arno', 'Initials': 'A', 'LastName': 'Olthoff', 'Affiliation': 'Klinik für Hals-Nasen-Ohrenheilkunde, Universitätsmedizin Göttingen, Phoniatrie und Pädaudiologie, Göttingen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hoffmann', 'Affiliation': 'Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie, Univ.-Klinik Ulm, Ulm, Germany.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Reiter', 'Affiliation': 'Sektion Phoniatrie und Pädaudiologie der Klinik für Hals-Nasen- Ohrenheilkunde, Kopf- und Halschirurgie, Univ.-Klinik Ulm, Germany.'}]",Laryngo- rhino- otologie,['10.1055/a-1190-4907']
2740,32557560,Spatial regression and spillover effects in cluster randomized trials with count outcomes.,"This paper describes methodology for analyzing data from cluster randomized trials with count outcomes, taking indirect effects as well spatial effects into account. Indirect effects are modelled using a novel application of a measure of depth within the intervention arm. Both direct and indirect effects can be estimated accurately even when the proposed model is misspecified. We use spatial regression models with Gaussian random effects, where the individual outcomes have distributions overdispersed with respect to the Poisson, and the corresponding direct and indirect effects have a marginal interpretation. To avoid spatial confounding, we use orthogonal regression, in which random effects represent spatial dependence using a homoscedastic and dimensionally-reduced modification of the intrinsic conditional autoregression (ICAR) model. We illustrate the methodology using spatial data from a pair-matched cluster randomized trial against the dengue mosquito vector Aedes aegypti, done in Trujillo, Venezuela. This article is protected by copyright. All rights reserved.",2020,"We illustrate the methodology using spatial data from a pair-matched cluster randomized trial against the dengue mosquito vector Aedes aegypti, done in Trujillo, Venezuela.",[],[],[],[],[],[],,0.0463177,"We illustrate the methodology using spatial data from a pair-matched cluster randomized trial against the dengue mosquito vector Aedes aegypti, done in Trujillo, Venezuela.","[{'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Anaya-Izquierdo', 'Affiliation': 'Department of Mathematical Sciences, University of Bath, Bath, BA2 7AY, U.K.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Alexander', 'Affiliation': 'MRC Tropical Epidemiology, London School of Hygiene and Tropical Medicine, London, WC1E 7HT, U.K.'}]",Biometrics,['10.1111/biom.13316']
2741,32557665,Pharmacokinetics and Pharmacodynamics of Garetosmab (Anti-Activin A): Results From a First-in-Human Phase 1 Study.,"We describe outcomes from the first-in-human study of garetosmab (a fully human monoclonal antibody that inhibits activin A) under development for the treatment of fibrodysplasia ossificans progressiva (FOP). In a double-blind, placebo-controlled phase 1 study, 40 healthy women of nonchildbearing potential were randomized to receive a single dose of intravenous garetosmab 0.3, 1, 3, or 10 mg/kg; subcutaneous garetosmab 300 mg; or placebo. Serum concentrations of functional garetosmab (with ≥1 arm free to bind to target), total activin A, and antidrug antibodies were measured predose and up to 113 days post-first dose. Garetosmab demonstrated an acceptable safety profile with no dose-limiting toxicities. Garetosmab displayed nonlinear pharmacokinetics with target-mediated elimination. With increasing doses of intravenous garetosmab, mean peak concentration increased in a dose-proportional manner; mean steady-state estimates ranged from 41.4 to 47.8 mL/kg. A greater than dose-proportional increase in mean area under the concentration-time curve from time zero extrapolated to infinity (range, 72.2-7520 mg*day/L) was observed, consistent with decreasing mean clearance (range, 4.35-1.34 mL/day/kg). Following administration of intravenous garetosmab, mean concentrations of total activin A increased in a dose-dependent manner. At 10 mg/kg, total activin A levels reached a state of little or no change between weeks 4 and 12, suggesting saturation of the target-mediated pathway. No safety signals were seen in this study to preclude investigation in patients. Following intravenous administration, garetosmab concentrations decreased quickly, then decreased over time (reflecting linear elimination), and finally decreased in a nonlinear phase, reflecting target-mediated elimination. Results here support further investigation. Garetosmab 10 mg/kg every 4 weeks intravenously is being evaluated in patients with FOP (NCT03188666).",2020,"Following administration of intravenous garetosmab, mean concentrations of total activin A increased in a dose-dependent manner.",['40 healthy women of nonchildbearing potential'],"['placebo', 'intravenous garetosmab 0.3, 1, 3, or 10 mg/kg; subcutaneous garetosmab 300 mg; or placebo', 'Garetosmab (Anti-Activin A']","['mean concentrations of total activin A', 'total activin', 'mean peak concentration', 'Serum concentrations of functional garetosmab (with ≥1 arm free to bind to target), total activin A, and antidrug antibodies', 'mean clearance']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0100748', 'cui_str': 'Activin A'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0100748', 'cui_str': 'Activin A'}, {'cui': 'C0050668', 'cui_str': 'Activin hormone'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",40.0,0.164094,"Following administration of intravenous garetosmab, mean concentrations of total activin A increased in a dose-dependent manner.","[{'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Vanhoutte', 'Affiliation': 'SGS Clinical Pharmacology Unit, Antwerp, Belgium.'}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Liang', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Ruddy', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Zhao', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.'}, {'ForeName': 'Tiera', 'Initials': 'T', 'LastName': 'Drewery', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.'}, {'ForeName': 'Yuhuan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'DelGizzi', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Forleo-Neto', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Rajadhyaksha', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Herman', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Davis', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1638']
2742,32557688,The contemplated average success probability for normally distributed models with an application to optimal sample sizes selection.,"We analytically obtain the average success probability (ASP) and the contemplated average success probability (CASP) for normally distributed observed differences in the treatment group and the placebo group means of the early trial and the confirmatory trial, assuming a uniform noninformative prior for the population treatment effect and a common known variance of the observations from both groups. For the CASP optimization problem with a fixed subtotal sample size of the early trial and the confirmatory trial of one arm larger than a threshold, we obtain the optimal plan of the sample sizes in a theorem. Moreover, in the theorem, we obtain the analytical formula of the optimal CASP as an increasing function of the subtotal sample size. After that, we calculate and compare the numerical values of the ASP with those in Table 1 of Chuang-Stein (2006). Finally, we investigate the numerical features of the CASP and find the optimal plan of the sample sizes for a given subtotal sample size.",2020,"We analytically obtain the average success probability (ASP) and the contemplated average success probability (CASP) for normally distributed observed differences in the treatment group and the placebo group means of the early trial and the confirmatory trial, assuming a uniform noninformative prior for the population treatment effect and a common known variance of the observations from both groups.",[],['placebo'],['average success probability (ASP'],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}]",,0.0755397,"We analytically obtain the average success probability (ASP) and the contemplated average success probability (CASP) for normally distributed observed differences in the treatment group and the placebo group means of the early trial and the confirmatory trial, assuming a uniform noninformative prior for the population treatment effect and a common known variance of the observations from both groups.","[{'ForeName': 'Ying-Ying', 'Initials': 'YY', 'LastName': 'Zhang', 'Affiliation': 'Department of Statistics and Actuarial Science, College of Mathematics and Statistics, Chongqing University, Chongqing, China.'}, {'ForeName': 'Teng-Zhong', 'Initials': 'TZ', 'LastName': 'Rong', 'Affiliation': 'Department of Statistics and Actuarial Science, College of Mathematics and Statistics, Chongqing University, Chongqing, China.'}, {'ForeName': 'Man-Man', 'Initials': 'MM', 'LastName': 'Li', 'Affiliation': 'Department of Statistics and Actuarial Science, College of Mathematics and Statistics, Chongqing University, Chongqing, China.'}]",Statistics in medicine,['10.1002/sim.8658']
2743,32557731,Impact of minimal invasive extracorporeal circulation on atrial fibrillation after coronary artery bypass surgery.,"OBJECTIVES


Postoperative atrial fibrillation (POAF) is the most common arrhythmia after cardiac surgery with an incidence between 15-50 % and pathophysiology not fully known. By choosing the method of extracorporeal circulation with focus on the reduction of systemic inflammatory response, one can potentially decrease the risk of POAF. In this prospective, randomized trial, we compared minimal invasive extracorporeal circulation (MiECC) with conventional extracorporeal circulation (CECC) in the prevention of POAF after coronary artery bypass surgery (CABG).
METHODS


A total of 240 patients who were scheduled for their first on-pump CABG, were randomized to MiECC or CECC. The primary outcome measure was the incidence of first POAF during the first 84 hours after surgery.
RESULTS


POAF occurred in 42/120 (35.0 %) MiECC patients and 43/120 (35.8%) CECC patients with non-significant difference between the groups (OR 1.043, 95% CI 0.591-1.843, p=0.884). The first postoperative creatine kinase-MB mass (CK-MBm) value was lower in the MiECC group, 13.95 [10.5-16.7] (median [IQR]) than in the CECC group, 15.30 [11.4-18.9] (p=0.036) whereas the use of perioperative dobutamine was higher in the MiECC group, 18/120 (15.0%), than in the CECC group 8/120 (6.7%) (p=0.038). The incidence of a stroke, perioperative myocardial infarction and resternotomy caused by bleeding did not differ in the MiECC and CECC groups. Age (OR 1.08, 95% CI 1.04-1.13, p=0.000) and peak postoperative CK-MBm (OR 1.57, 95% CI 1.06-2.37, p=0.026) were independent predictors of POAF.
CONCLUSION


MiECC compared to CECC was not effective in reducing the incidence of POAF in patients undergoing CABG.",2020,"The first postoperative creatine kinase-MB mass (CK-MBm) value was lower in the MiECC group, 13.95","['POAF after coronary artery bypass surgery (CABG', 'patients undergoing CABG', 'atrial fibrillation after coronary artery bypass surgery', '240 patients who were scheduled for their first on-pump CABG']","['minimal invasive extracorporeal circulation', 'MiECC', 'minimal invasive extracorporeal circulation (MiECC) with conventional extracorporeal circulation (CECC', 'CECC', 'MiECC or CECC']","['postoperative creatine kinase-MB mass (CK-MBm) value', 'POAF', 'peak postoperative CK-MBm', 'risk of POAF', 'incidence of first POAF', 'perioperative dobutamine', 'incidence of a stroke, perioperative myocardial infarction and resternotomy caused by bleeding', 'incidence of POAF']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0015354', 'cui_str': 'Extracorporeal circulation procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0010290', 'cui_str': 'Creatine kinase isoenzyme, MB fraction'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0012963', 'cui_str': 'Dobutamine'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",240.0,0.0559402,"The first postoperative creatine kinase-MB mass (CK-MBm) value was lower in the MiECC group, 13.95","[{'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Ellam', 'Affiliation': 'Department of Anesthesiology and Operative Services, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Hartikainen', 'Affiliation': 'Heart Center, Kuopio University Hospital, School of Medicine, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Korvenoja', 'Affiliation': 'Acute Care, South Karelia Central Hospital, Lappeenranta, Finland.'}, {'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Pitkänen', 'Affiliation': 'Department of Anesthesiology and Operative Services, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Esko', 'Initials': 'E', 'LastName': 'Tyrväinen', 'Affiliation': 'Department of Anesthesiology and Operative Services, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Valtola', 'Affiliation': 'Heart Center, Kuopio University Hospital, School of Medicine, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Jari', 'Initials': 'J', 'LastName': 'Halonen', 'Affiliation': 'Heart Center, Kuopio University Hospital, School of Medicine, University of Eastern Finland, Kuopio, Finland.'}]",Artificial organs,['10.1111/aor.13756']
2744,32557904,The added value of geriatric assessment in evaluating a patient's Health-Related Quality-of-Life: A study in ≥70-year-old early-stage invasive breast cancer patients.,"OBJECTIVE


The objective of this study was to assess the relationship between geriatric assessment (GA) and health-related Quality-of-Life (HRQOL) in older patients with breast cancer.
METHODS


Patients were assigned either to adjuvant chemotherapy (CTG) or to a control group (CG). Spearman rank coefficients (ρ) calculated correlations between HRQOL and GA at baseline, 3 months and 1 year. Multivariate regressions modelled the prognostic value of GA in evaluating of a patient's HRQOL and the accuracy of baseline GA in predicting HRQOL decline (change of ≥10 points).
RESULTS


The analysis included 57 patients in the CTG and 52 in the CG. Strong correlations (ρ ≥ 0.5) were reported between the EORTC QLQ-C30 Physical Functioning Scale and Activities of Daily Living (ADL), Instrumental ADL (iADL) and Leuven Oncogeriatric Frailty Score Scale (LOFS). Multivariate models demonstrated that poor iADL, ADL and LOFS (CG) and ADL and iADL (CTG) contributed to a statistically (all p < .05) worse HRQOL. The relative gain in predicting 3-month and 1-year HRQOL decline was 24.1% and 4.7% (CG) and 6.1% and 18.3% (CTG).
CONCLUSION


Our results show that the functional measures in the GA are strongly correlated with patient self-reported functioning. Poor baseline GA has a modest probability of predicting HRQOL deterioration.",2020,"Strong correlations (ρ ≥ 0.5) were reported between the EORTC QLQ-C30 Physical Functioning Scale and Activities of Daily Living (ADL), Instrumental ADL (iADL) and Leuven Oncogeriatric Frailty Score Scale (LOFS).","['57 patients in the CTG and 52 in the CG', 'older patients with breast cancer', '≥70-year-old early-stage invasive breast cancer patients', 'Patients']",['adjuvant chemotherapy (CTG) or to a control group (CG'],"['HRQOL', 'EORTC QLQ-C30 Physical Functioning Scale and Activities of Daily Living (ADL), Instrumental ADL (iADL) and Leuven Oncogeriatric Frailty Score Scale (LOFS', 'geriatric assessment (GA) and health-related Quality-of-Life (HRQOL', 'poor iADL, ADL and LOFS (CG) and ADL and iADL (CTG', 'relative gain in predicting 3-month and 1-year HRQOL decline']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0853879', 'cui_str': 'Invasive carcinoma of breast'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0017463', 'cui_str': 'Geriatric screening'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",57.0,0.0496865,"Strong correlations (ρ ≥ 0.5) were reported between the EORTC QLQ-C30 Physical Functioning Scale and Activities of Daily Living (ADL), Instrumental ADL (iADL) and Leuven Oncogeriatric Frailty Score Scale (LOFS).","[{'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Quinten', 'Affiliation': 'Laboratory of Experimental Oncology (LEO), Department of Oncology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Kenis', 'Affiliation': 'Department of General Medical Oncology and Geriatric Medicine, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'Hamaker', 'Affiliation': 'Department of General Medicine, Diakonessenhuis, Utrecht, The Netherlands.'}, {'ForeName': 'Annemarie', 'Initials': 'A', 'LastName': 'Coolbrandt', 'Affiliation': 'Department of General Medical Oncology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Brouwers', 'Affiliation': 'Laboratory of Experimental Oncology (LEO), Department of Oncology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Lissandra', 'Initials': 'L', 'LastName': 'Dal Lago', 'Affiliation': 'Department of Medicine, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Neven', 'Affiliation': 'Multidisciplinary Breast Center, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vuylsteke', 'Affiliation': 'Department of Medical Oncology, Université Catholique de Louvain, Namur, Belgium.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Debrock', 'Affiliation': 'Department of Medical Oncology, Ziekenhuizen Oost Limburg (ZOL), Genk, Belgium.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Van Den Bulck', 'Affiliation': 'Department of Medical Oncology, Imelda Ziekenhuizen Bondheiden, Bonheiden, Belgium.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Smeets', 'Affiliation': 'Multidisciplinary Breast Center, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schöffski', 'Affiliation': 'Laboratory of Experimental Oncology (LEO), Department of Oncology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Wedding', 'Affiliation': 'Department of Palliative Care, Friedrich-Schiller-University, Jena, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Wildiers', 'Affiliation': 'Laboratory of Experimental Oncology (LEO), Department of Oncology, KU Leuven, Leuven, Belgium.'}]",European journal of cancer care,['10.1111/ecc.13278']
2745,32557911,A daytime nap does not increase mnemonic discrimination ability.,"It has been proposed that sleep readies the brain for novel learning, and previous work has shown that sleep loss impairs the ability to encode new memories. In the present study, we examined if a daytime nap would increase mnemonic discrimination (MD) performance. MD is the ability to differentiate between memories that are similar but not identical. Participants performed the Mnemonic Similarity Task (MST) twice, once in the morning and once in the afternoon. The goal of this task is to distinguish stimuli that have been seen before from novel stimuli that are similar but not identical. After the morning MST, participants were randomly allocated into either a sleep or a wake group. The sleep group had a 2-hr nap opportunity, whereas the wake group spent a similar amount of time passively resting. All participants then performed a second MST in the afternoon with a novel set of images. Results did not show any support for increased MD ability after a nap. There was, however, a correlation showing that an increase in sleepiness between sessions predicted a decrease in MD performance. Future work must systematically examine how strong sleep manipulations that are needed for sleep to have an effect on encoding ability, as well as which kind of memory tasks that are sensitive to sleep manipulations. More knowledge about the relationship between sleep and the ability to differentiate similar memories from each other is important because impaired MD ability has previously been reported in various groups in which sleep disturbances are also common.",2020,Results did not show any support for increased MD ability after a nap.,[],[],"['mnemonic discrimination (MD) performance', 'MD ability', 'Mnemonic Similarity Task (MST', 'sleepiness', 'MD performance']",[],[],"[{'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}]",,0.0156178,Results did not show any support for increased MD ability after a nap.,"[{'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Davidson', 'Affiliation': 'Department of Psychology, Lund University, Lund, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jönsson', 'Affiliation': 'School of Education of Environment, Centre for Psychology, Kristianstad University, Kristianstad, Sweden.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Johansson', 'Affiliation': 'Department of Psychology, Lund University, Lund, Sweden.'}]",Journal of sleep research,['10.1111/jsr.13128']
2746,32557921,Fetal cerebral Doppler changes and outcome in late preterm fetal growth restriction: prospective cohort study.,"OBJECTIVES


To explore the association between fetal umbilical and middle cerebral artery (MCA) Doppler abnormalities and outcome in late preterm pregnancies at risk of fetal growth restriction.
METHODS


This was a prospective cohort study of singleton pregnancies at risk of fetal growth restriction at 32 + 0 to 36 + 6 weeks of gestation, enrolled in 33 European centers between 2017 and 2018, in which umbilical and fetal MCA Doppler velocimetry was performed. Pregnancies were considered at risk of fetal growth restriction if they had estimated fetal weight and/or abdominal circumference (AC) < 10 th  centile, abnormal arterial Doppler and/or a fall in AC growth velocity of more than 40 centile points from the 20-week scan. Composite adverse outcome comprised both adverse immediate birth outcome and major neonatal morbidity. Using a range of cut-off values, the association of MCA pulsatility index and umbilicocerebral ratio (UCR) with composite adverse outcome was explored.
RESULTS


The study population comprised 856 women. There were two (0.2%) intrauterine deaths. Median gestational age at delivery was 38 (interquartile range (IQR), 37-39) weeks and birth weight was 2478 (IQR, 2140-2790) g. Compared with infants with normal outcome, those with composite adverse outcome (n = 93; 11%) were delivered at an earlier gestational age (36 vs 38 weeks) and had a lower birth weight (1900 vs 2540 g). The first Doppler observation of MCA pulsatility index < 5 th  centile and UCR Z-score above gestational-age-specific thresholds (1.5 at 32-33 weeks and 1.0 at 34-36 weeks) had the highest relative risks (RR) for composite adverse outcome (RR 2.2 (95% CI, 1.5-3.2) and RR 2.0 (95% CI, 1.4-3.0), respectively). After adjustment for confounders, the association between UCR Z-score and composite adverse outcome remained significant, although gestational age at delivery and birth-weight Z-score had a higher predictive importance.
CONCLUSION


In this prospective multicenter study, fetal cerebral Doppler abnormalities were found to be associated with adverse outcome in late preterm singleton pregnancies at risk of fetal growth restriction. Whether cerebral redistribution is a marker describing the severity of fetal growth restriction or an independent risk factor for adverse outcome remains unclear, and whether it is useful for clinical management can be answered only in a randomized trial. This article is protected by copyright. All rights reserved.",2020,"In this prospective multicenter study, fetal cerebral Doppler abnormalities were found to be associated with adverse outcome in late preterm singleton pregnancies at risk of fetal growth restriction.","['late preterm pregnancies at risk of fetal growth restriction', 'singleton pregnancies at risk of fetal growth restriction at 32\u2009+\u20090 to 36\u2009+\u20096\u2009weeks of gestation, enrolled in 33 European centers between 2017 and 2018, in which umbilical and fetal MCA Doppler velocimetry was performed', 'Median gestational age at delivery was 38 (interquartile range (IQR), 37-39)\xa0weeks and birth weight was 2478 (IQR, 2140-2790', 'late preterm fetal growth restriction', 'late preterm singleton pregnancies at risk of fetal growth restriction', '856 women']",[],"['fetal weight and/or abdominal circumference (AC', 'MCA pulsatility index', 'gestational age at delivery and birth-weight Z-score', 'highest relative risks (RR) for composite adverse outcome', 'intrauterine deaths', 'lower birth weight', 'MCA pulsatility index and umbilicocerebral ratio (UCR', 'adverse immediate birth outcome and major neonatal morbidity']","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0015934', 'cui_str': 'Fetal growth restriction'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041638', 'cui_str': 'Umbilical structure'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0162462', 'cui_str': 'Velocimetry'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C4517894', 'cui_str': '856'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0751992', 'cui_str': 'Body Weight, Fetal'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0015927', 'cui_str': 'Fetal death'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",,0.122709,"In this prospective multicenter study, fetal cerebral Doppler abnormalities were found to be associated with adverse outcome in late preterm singleton pregnancies at risk of fetal growth restriction.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Stampalija', 'Affiliation': 'Unit of Fetal Medicine and Prenatal Diagnosis, Institute for Maternal and Child Health, IRCCS Burlo Garofolo and Department of Medicine, Surgery and Health Sciences, University of Trieste, Trieste, Italy.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Thornton', 'Affiliation': 'School of Clinical Sciences, University of Nottingham, Division of Obstetrics and Gynaecology, Maternity Department, City Hospital, Nottingham, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Marlow', 'Affiliation': ""Academic Neonatology, UCL Elizabeth Garrett Anderson Institute for Women's Health, University College London, London, UK.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Napolitano', 'Affiliation': 'Fetal Medicine Unit, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bhide', 'Affiliation': ""Fetal Medicine Unit, St George's University Hospitals NHS Foundation Trust and Molecular & Clinical Sciences Research Institute, St George's, University of London, London, UK.""}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Bilardo', 'Affiliation': 'Department of Obstetrics and Gynecology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gordijn', 'Affiliation': 'Department of Obstetrics and Gynecology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Gyselaers', 'Affiliation': 'Faculty of Medicine and Life Sciences, Hasselt University, Agoralaan, Diepenbeek, Belgium, Department of Obstetrics & Gynaecology, Ziekenhuis Oost-Limburg, Genk and Department Physiology, Hasselt University, Diepenbeek, Belgium.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Valensise', 'Affiliation': 'Department of Obstetrics and Gynecology, Tor Vergata University and Division of Obstetrics and Gynecology, Policlinico Casilino Hospital, Rome, Italy.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hecher', 'Affiliation': 'Department of Obstetrics and Fetal Medicine, University-Hospital Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'R K', 'Initials': 'RK', 'LastName': 'Sande', 'Affiliation': 'Department of Obstetrics and Gynecology, Stavanger University Hospital, Stavanger and Department of Clinical Science, University of Bergen, Bergen, Norway.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lindgren', 'Affiliation': 'Center for Fetal Medicine, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Bergman', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Arabin', 'Affiliation': 'Department of Obstetrics Charite, Humboldt University Berlin and Clara Angela Foundation, Berlin, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Breeze', 'Affiliation': 'Fetal Medicine Unit, Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Wee', 'Affiliation': 'The Princess Alexandra Hospital NHS Trust, Harlow, UK.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Ganzevoort', 'Affiliation': 'Department of Obstetrics and Gynecology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Richter', 'Affiliation': 'Department of Gynecology and Obstetrics, UZ Leuven and Department of Regeneration and Development, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Berger', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Brodszki', 'Affiliation': 'Department of Pediatric Surgery and Neonatology, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Derks', 'Affiliation': 'Department of Perinatal Medicine, University of Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Mecacci', 'Affiliation': 'Department of Health Sciences, University of Florence, Obstetrics and Gynecology, Careggi University Hospital, Florence, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Maruotti', 'Affiliation': ""Department of Neurosciences, Reproductive and Dentistry Sciences, University of Naples 'Federico II', Naples, Italy.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lobmaier', 'Affiliation': 'Department of Obstetrics and Gynecology, Klinikum Rechts Der Isar, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Prefumo', 'Affiliation': 'Department of Obstetrics and Gynecology, ASST Spedali Civili di Brescia and University of Brescia, Brescia, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Klaritsch', 'Affiliation': 'Department of Gynecology and Obstetrics, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Calda', 'Affiliation': 'Department of Obstetrics and Gynaecology, General University Hospital and First Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ebbing', 'Affiliation': ""Department of Obstetrics and Gynecology, Haukeland University Hospital, Bergen and Myklestad Kristi, St Olav's Hospital, Trondheim, Norway.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Frusca', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Parma, Parma, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Raio', 'Affiliation': 'Department of Obstetrics & Gynecology, University Hospital of Bern, Bern, Switzerland.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Visser', 'Affiliation': 'Department of Obstetrics, Division of Woman and Baby, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Krofta', 'Affiliation': 'Institute for the Care of Mother and Child, Prague, Czech Republic and Third Medical Faculty, Charles University, Prague, Czech Republic.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Cetin', 'Affiliation': ""Department of Obstetrics and Gynecology, Vittore Buzzi Children's Hospital, University of Milan, Milan, Italy.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ferrazzi', 'Affiliation': ""Department of Obstetrics and Gynecology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and Department of Clinical Sciences and Community Health, Università degli Studi di Milano, Milan, Italy.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Cesari', 'Affiliation': ""Department of Obstetrics and Gynecology, Vittore Buzzi Children's Hospital, University of Milan, Milan, Italy.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wolf', 'Affiliation': 'Department of Obstetrics and Gynecology, Amsterdam University Medical Center (Location AMC), University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lees', 'Affiliation': ""Imperial College School of Medicine, Imperial College London and Department of Fetal Medicine, Queen Charlotte's and Chelsea Hospital, Imperial College NHS trust, London, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology,['10.1002/uog.22125']
2747,32557923,Splenic Switch-Off for Determining the Optimal Dosage for Adenosine Stress Cardiac MR in Terms of Stress Effectiveness and Patient Safety.,"BACKGROUND


Adenosine stress MRI is well established for the evaluation of known and suspected coronary artery disease. However, a proportion of patients might be ""under-stressed"" using the standard adenosine dose.
PURPOSE


To compare three different adenosine dosages for stress MRI in terms of stress adequacy based on splenic switch-off (SSO) and limiting side effects.
STUDY TYPE


Prospective.
POPULATION


In all, 100 patients were randomized in group 1 (33 pts), group 2 (34 pts), and group 3 (33 pts), receiving dosages of 140 μg/kg/min, 175 μg/kg/min, or 210 μg/kg/min, respectively. SSO was evaluated visually and quantitatively.
SEQUENCE


Stress perfusion was performed using a 1.5T scanner in three short axes using a standard single-shot, saturation recovery gradient-echo sequence.
ASSESSMENT


Three blinded experienced operators evaluated SSO on stress and rest perfusion acquisitions in the three groups. The signal intensity of the spleen and myocardium and the presence of inducible ischemia and late gadolinium enhancement were assessed.
STATISTICAL ANALYSIS


T-test, analysis of variance (ANOVA), chi-squared test, and Pearson's correlation coefficient.
RESULTS


SSO was present more frequently in patients receiving 175 μg/kg/min and 210 μg/kg/min (31/33 [94%] and 27/29 [93%], respectively) compared to those receiving the standard dose (19/33 [58%], P < 0.05). A positive stress result was noted in 3/33 (9%) patients receiving 140 μg/kg/min vs. 9/33 (27%) patients receiving 175 μg/kg/min and 10/31 (33%) patients receiving 210 μg/kg/min (P < 0.05 for all, P < 0.05 for group 1 vs. groups 2, 3). The relative decrease of splenic signal intensity at hyperemia vs. baseline was significantly lower in group 1 compared to groups 2 and 3 (-33% vs. -54%, -56%, respectively; P < 0.05). No adverse events during scanning were noted in groups 1 and 2, whereas in group 3 four examinations were stopped due to severe dyspnea (n = 2) and AV-blockage (n = 2).
DATA CONCLUSION


A dosage of 175 μg/kg/min adenosine results in a higher proportion of SSO, which may be an indirect marker of adequate coronary vasodilatation and simultaneously offers similar safety compared to the standard 140 μg/kg/min dosage.
LEVEL OF EVIDENCE


1 TECHNICAL EFFICACY STAGE: 2.",2020,"The relative decrease of splenic signal intensity at hyperemia vs. baseline was significantly lower in group 1 compared to groups 2 and 3 (-33% vs. -54%, -56%, respectively; P < 0.05).",['100 patients'],[],"['SSO', 'SSO on stress and rest perfusion acquisitions', 'splenic signal intensity', 'severe dyspnea', 'adverse events', 'signal intensity of the spleen and myocardium and the presence of inducible ischemia and late gadolinium enhancement']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0037993', 'cui_str': 'Splenic structure'}, {'cui': 'C0424598', 'cui_str': 'Illness: Switched off'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027061', 'cui_str': 'Cardiac muscle (tissue)'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}]",100.0,0.060122,"The relative decrease of splenic signal intensity at hyperemia vs. baseline was significantly lower in group 1 compared to groups 2 and 3 (-33% vs. -54%, -56%, respectively; P < 0.05).","[{'ForeName': 'Sorin', 'Initials': 'S', 'LastName': 'Giusca', 'Affiliation': 'Department of Cardiology Angiology and Pneumology, GRN Hospital Weinheim, Weinheim, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wolf', 'Affiliation': 'Department of Cardiology Angiology and Pneumology, GRN Hospital Weinheim, Weinheim, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Hofmann', 'Affiliation': 'Department of Cardiology Angiology and Pneumology, GRN Hospital Weinheim, Weinheim, Germany.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Hagstotz', 'Affiliation': 'Department of Cardiology Angiology and Pneumology, GRN Hospital Weinheim, Weinheim, Germany.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Forschner', 'Affiliation': 'Radiology Practice, Weinheim, Germany.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Schueler', 'Affiliation': 'Department of Cardiology Angiology and Pneumology, GRN Hospital Weinheim, Weinheim, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nunninger', 'Affiliation': 'Radiology Practice, Weinheim, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Kelle', 'Affiliation': 'Department of Internal Medicine/Cardiology, German Heart Center Berlin, Berlin, Germany.'}, {'ForeName': 'Grigorios', 'Initials': 'G', 'LastName': 'Korosoglou', 'Affiliation': 'Department of Cardiology Angiology and Pneumology, GRN Hospital Weinheim, Weinheim, Germany.'}]",Journal of magnetic resonance imaging : JMRI,['10.1002/jmri.27248']
2748,32558047,Introduction of mini-clinical evaluation exercise in teaching dental radiology-A pilot study.,"INTRODUCTION


Workplace-based assessments are methods that can be applied for assessing competence and performance. One of these methods is the mini-clinical evaluation exercise (mini-CEX). This study was conducted to determine the role of mini-CEX in students' performance assessment on panoramic x-ray reporting at dental radiology course.
MATERIALS AND METHODS


A workshop as training for the assessors and the participants was conducted before the primary test. All participants (n = 36) were randomly allocated into six groups. Each group had three seminaries in which every student reported a panoramic X-ray. Students were directly observed and rated by an assessor on a modified mini-CEX rating form. Then, a self-assessment of the students and a systematic feedback session were performed. Finally, the students and the assessors were evaluated for the acceptability and satisfaction with this tool.
RESULTS


The mean duration of the assessment and the feedback decreased significantly from the first seminar to the third seminar (p < 0.0001). Comparison of the results of the mini-CEX of all three assessments showed that students displayed a significantly better performance in evaluating the upper jaw and the soft tissue (p < 0.05). There was no significant improvement for the other aspects of the rating form. Overall, both students and assessors reported a high level of satisfaction in using the mini-CEX rating form.
CONCLUSION


Due to the objectivity and transparency of the assessment, the mini-CEX helped to improve the performance on reporting panoramic x-rays. Besides that, the structured feedback had major impact on the improvement. Overall, the assessors and the participants reported a high level of satisfaction using the rating form. Therefore, the mini-CEX may be an effective method for performing workplace-based assessments to evaluate students' performance on reporting panoramic X-rays.",2020,The mean duration of the assessment and the feedback decreased significantly from the first seminar to the third seminar (p < 0.0001).,"['All participants (n = 36', ""students' performance assessment on panoramic x-ray reporting at dental radiology course""]","['mini-clinical evaluation exercise', 'mini-CEX']","['acceptability and satisfaction', 'mean duration of the assessment and the feedback']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]",36.0,0.0264222,The mean duration of the assessment and the feedback decreased significantly from the first seminar to the third seminar (p < 0.0001).,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bock', 'Affiliation': 'Department of Oral, Maxillofacial Surgery, University Hospital of Aachen University, Pauwelsstrasse 30, 52074, Aachen, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Peters', 'Affiliation': 'Department of Oral, Maxillofacial Surgery, University Hospital of Aachen University, Pauwelsstrasse 30, 52074, Aachen, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Elvers', 'Affiliation': 'Department of Oral, Maxillofacial Surgery, University Hospital of Aachen University, Pauwelsstrasse 30, 52074, Aachen, Germany.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Wittenborn', 'Affiliation': 'Department of Oral, Maxillofacial Surgery, University Hospital of Aachen University, Pauwelsstrasse 30, 52074, Aachen, Germany.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Kniha', 'Affiliation': 'Department of Oral, Maxillofacial Surgery, University Hospital of Aachen University, Pauwelsstrasse 30, 52074, Aachen, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Gerressen', 'Affiliation': 'Department of Oral, Maxillofacial and Plastic Facial Surgery, Heinrich Braun Hospital, Karl-Keil-Straße 35, 08060, Zwickau, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Hölzle', 'Affiliation': 'Department of Oral, Maxillofacial Surgery, University Hospital of Aachen University, Pauwelsstrasse 30, 52074, Aachen, Germany.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Modabber', 'Affiliation': 'Department of Oral, Maxillofacial Surgery, University Hospital of Aachen University, Pauwelsstrasse 30, 52074, Aachen, Germany.'}]",European journal of dental education : official journal of the Association for Dental Education in Europe,['10.1111/eje.12558']
2749,32558052,The effect of mirabegron on energy expenditure and brown adipose tissue in healthy lean South Asian and Europid men.,"AIMS


To compare the effects of cold exposure and the β3-adrenergic receptor agonist mirabegron on plasma lipids, energy expenditure and brown adipose tissue (BAT) activity in South Asians versus Europids.
MATERIAL AND METHODS


Ten lean Dutch South Asian (age 18-30 years; BMI 18-25 kg/m 2  ) and ten age- and BMI-matched Europid men participated in a randomized, double-blinded, cross-over study consisting of three interventions; short-term (approx. 2 hours) cold exposure, mirabegron (200 mg one dose p.o.) and placebo. Before and after each intervention, we performed lipidomic analysis in serum, assessed resting energy expenditure (REE) and skin temperature, and measured BAT fat fraction by MRI.
RESULTS


In both ethnicities, cold exposure increased levels of many serum lipid species, whereas mirabegron only increased free fatty acids. Cold exposure increased lipid oxidation in both ethnicities, while mirabegron increased lipid oxidation in Europids only. Cold exposure and mirabegron enhanced supraclavicular skin temperature in both ethnicities. Cold exposure decreased BAT fat fraction in both ethnicities. After combination of data from both ethnicities, mirabegron decreased BAT fat fraction compared to placebo.
CONCLUSIONS


In South Asians and Europids, cold exposure and mirabegron induced beneficial metabolic effects. When combining both ethnicities, cold exposure and mirabegron increased REE and lipid oxidation, coinciding with a higher supraclavicular skin temperature and lower BAT fat fraction. This article is protected by copyright. All rights reserved.",2020,"In both ethnicities, cold exposure increased levels of many serum lipid species, whereas mirabegron only increased free fatty acids.","['healthy lean South Asian and Europid men', 'South Asians versus Europids', 'Ten lean Dutch South Asian (age 18-30\u2009years']","['β3-adrenergic receptor agonist mirabegron', 'mirabegron', 'three interventions; short-term (approx. 2\u2009hours) cold exposure, mirabegron (200\u2009mg one dose p.o.) and placebo']","['supraclavicular skin temperature', 'lipidomic analysis in serum, assessed resting energy expenditure (REE) and skin temperature, and measured BAT fat fraction by MRI', 'plasma lipids, energy expenditure and brown adipose tissue (BAT) activity', 'free fatty acids', 'lipid oxidation', 'levels of many serum lipid species', 'BAT fat fraction', 'REE and lipid oxidation, coinciding with a higher supraclavicular skin temperature and lower BAT fat fraction', 'beneficial metabolic effects']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0001648', 'cui_str': 'Adrenergic receptor agonist'}, {'cui': 'C2983812', 'cui_str': 'mirabegron'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0231275', 'cui_str': 'Cold exposure'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0589496', 'cui_str': 'Supraclavicular approach'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C4727082', 'cui_str': 'Lipidomics'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0006298', 'cui_str': 'Brown fat'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",10.0,0.0787891,"In both ethnicities, cold exposure increased levels of many serum lipid species, whereas mirabegron only increased free fatty acids.","[{'ForeName': 'Kimberly J', 'Initials': 'KJ', 'LastName': 'Nahon', 'Affiliation': 'Department of Medicine, Division of Endocrinology.'}, {'ForeName': 'Laura G M', 'Initials': 'LGM', 'LastName': 'Janssen', 'Affiliation': 'Department of Medicine, Division of Endocrinology.'}, {'ForeName': 'Aashley S D', 'Initials': 'ASD', 'LastName': 'SardjoeMishre', 'Affiliation': 'C.J. Gorter Center for High Field MRI, Department of Radiology.'}, {'ForeName': 'Manu P', 'Initials': 'MP', 'LastName': 'Bilsen', 'Affiliation': 'Department of Medicine, Division of Endocrinology.'}, {'ForeName': 'Jari A', 'Initials': 'JA', 'LastName': 'van der Eijk', 'Affiliation': 'C.J. Gorter Center for High Field MRI, Department of Radiology.'}, {'ForeName': 'Kani', 'Initials': 'K', 'LastName': 'Botani', 'Affiliation': 'Department of Medicine, Division of Endocrinology.'}, {'ForeName': 'Lisanne A', 'Initials': 'LA', 'LastName': 'Overduin', 'Affiliation': 'Department of Medicine, Division of Endocrinology.'}, {'ForeName': 'Jonatan R', 'Initials': 'JR', 'LastName': 'Ruiz', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through physical activity"" research group, Sport and Health University Research Institute (iMUDS). Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Spain.'}, {'ForeName': 'Jedrzej', 'Initials': 'J', 'LastName': 'Burakiewicz', 'Affiliation': 'C.J. Gorter Center for High Field MRI, Department of Radiology.'}, {'ForeName': 'Oleh', 'Initials': 'O', 'LastName': 'Dzyubachyk', 'Affiliation': 'Department of Radiology, Division of Image Processing (LKEB), Leiden University Medical Center, ZA, Leiden, the Netherlands.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Webb', 'Affiliation': 'C.J. Gorter Center for High Field MRI, Department of Radiology.'}, {'ForeName': 'Hermien E', 'Initials': 'HE', 'LastName': 'Kan', 'Affiliation': 'C.J. Gorter Center for High Field MRI, Department of Radiology.'}, {'ForeName': 'Jimmy F P', 'Initials': 'JFP', 'LastName': 'Berbée', 'Affiliation': 'Department of Medicine, Division of Endocrinology.'}, {'ForeName': 'Jan-Bert', 'Initials': 'JB', 'LastName': 'van Klinken', 'Affiliation': 'Department of Human Genetics, Leiden University Medical Center, ZA, Leiden, the Netherlands.'}, {'ForeName': 'Ko Willems', 'Initials': 'KW', 'LastName': 'van Dijk', 'Affiliation': 'Department of Medicine, Division of Endocrinology.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'van Weeghel', 'Affiliation': 'Laboratory Genetic Metabolic Diseases, Amsterdam UMC, University of Amsterdam, Amsterdam Gastroenterology and Metabolism, Amsterdam Cardiovascular Sciences, AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'Frédéric M', 'Initials': 'FM', 'LastName': 'Vaz', 'Affiliation': 'Laboratory Genetic Metabolic Diseases, Amsterdam UMC, University of Amsterdam, Amsterdam Gastroenterology and Metabolism, Amsterdam Cardiovascular Sciences, AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'Tamer', 'Initials': 'T', 'LastName': 'Coskun', 'Affiliation': 'Department of Diabetes/Endocrine, Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, Indiana, US.'}, {'ForeName': 'Ingrid M', 'Initials': 'IM', 'LastName': 'Jazet', 'Affiliation': 'Department of Medicine, Division of Endocrinology.'}, {'ForeName': 'Sander', 'Initials': 'S', 'LastName': 'Kooijman', 'Affiliation': 'Department of Medicine, Division of Endocrinology.'}, {'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Martinez-Tellez', 'Affiliation': 'Department of Medicine, Division of Endocrinology.'}, {'ForeName': 'Mariëtte R', 'Initials': 'MR', 'LastName': 'Boon', 'Affiliation': 'Department of Medicine, Division of Endocrinology.'}, {'ForeName': 'Patrick C N', 'Initials': 'PCN', 'LastName': 'Rensen', 'Affiliation': 'Department of Medicine, Division of Endocrinology.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14120']
2750,32558178,The Cost-Effectiveness of Transurethral resection of the prostate versus Thulium laser transurethral vaporesection of the prostate in the UNBLOCS randomised controlled trial for benign prostatic obstruction.,"OBJECTIVE


To determine the cost-effectiveness of the current gold standard operation of transurethral resection of the prostate (TURP) compared to the new laser technique of thulium laser transurethral vaporesection of the prostate (ThuVARP) in men with benign prostatic obstruction (BPO) within the United Kingdom (UK) National Health Service (NHS).
PATIENTS AND METHODS


The trial was conducted across seven UK centres (four university teaching hospitals and three district general hospitals). 410 men aged 18 years and older presenting with either bothersome lower urinary tract symptoms (LUTS) or urinary retention secondary to BPO, and suitable for surgery, were randomised (whilst under anaesthetic) 1:1 to receive the TURP or ThuVARP procedure. Resource use in relation to the operation, initial inpatient stay, and subsequent use of NHS services was collected for 12 months from randomisation (equivalent to primary effectiveness outcome) using hospital records and patient questionnaires. Resources were valued using UK reference costs. QALYs (quality adjusted life years) were calculated from the EQ-5D-5L questionnaire completed at baseline, 3- and 12-months. Total adjusted mean costs, QALYs and incremental Net Monetary Benefit statistics were calculated: cost-effectiveness acceptability curves and sensitivity analyses addressed uncertainty.
RESULTS


The total adjusted mean secondary care cost over the 12 months in the TURP arm (£4244) was £9 (95% CI of -£376 to £359) lower than the ThuVARP arm (£4253). The ThuVARP operation took on average 21 minutes longer than TURP. The adjusted mean difference of Quality Adjusted Life Years (QALYs) (0.01 favouring TURP, 95% CI of -0.01 to 0.04) was similar between the arms. There is a 76% probability that TURP is the cost-effective option compared with ThuVARP at the £20,000 per QALY willingness to pay threshold used by National Institute for Health and Care Excellence (NICE).
CONCLUSION


One of the anticipated benefits of the laser surgery, reduced length of hospital stay with an associated reduction in cost, did not materialise within the study. The longer duration of the ThuVARP procedure is important to consider, both from a patient perspective in terms of increased time under anaesthetic, and from a service delivery perspective. TURP remains a highly cost-effective treatment for men with BPO.",2020,"The adjusted mean difference of Quality Adjusted Life Years (QALYs) (0.01 favouring TURP, 95% CI of -0.01 to 0.04) was similar between the arms.","['men with BPO', 'seven UK centres (four university teaching hospitals and three district general hospitals', 'benign prostatic obstruction', 'men with benign prostatic obstruction (BPO) within the United Kingdom (UK) National Health Service (NHS', '410 men aged 18 years and older presenting with either bothersome lower urinary tract symptoms (LUTS) or urinary retention secondary to BPO, and suitable for surgery']","['TURP', 'ThuVARP', 'TURP or ThuVARP procedure', 'Transurethral resection of the prostate versus Thulium laser transurethral vaporesection', 'transurethral resection of the prostate (TURP', 'new laser technique of thulium laser transurethral vaporesection of the prostate (ThuVARP']","['length of hospital stay', 'Quality Adjusted Life Years (QALYs', 'Total adjusted mean costs, QALYs and incremental Net Monetary Benefit statistics were calculated: cost-effectiveness acceptability curves and sensitivity analyses addressed uncertainty', 'Cost-Effectiveness', 'cost-effectiveness']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0268889', 'cui_str': 'Prostatic obstruction'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040066', 'cui_str': 'Thulium'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0578996', 'cui_str': 'Laser - action'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}]",410.0,0.0449528,"The adjusted mean difference of Quality Adjusted Life Years (QALYs) (0.01 favouring TURP, 95% CI of -0.01 to 0.04) was similar between the arms.","[{'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Noble', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, 1-5 Whiteladies Road, Bristol, BS8 1NU, UK.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Ahern', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Worthington', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hashim', 'Affiliation': 'Bristol Urological Institute, Level 3, Learning and Research Building, Southmead Hospital, North Bristol NHS Trust, Bristol, BS10 5NB, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Taylor', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Young', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Brookes', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Abrams', 'Affiliation': 'Bristol Urological Institute, Level 3, Learning and Research Building, Southmead Hospital, North Bristol NHS Trust, Bristol, BS10 5NB, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Johnson', 'Affiliation': 'Bristol Urological Institute, Level 3, Learning and Research Building, Southmead Hospital, North Bristol NHS Trust, Bristol, BS10 5NB, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Khan', 'Affiliation': 'Bristol Urological Institute, Level 3, Learning and Research Building, Southmead Hospital, North Bristol NHS Trust, Bristol, BS10 5NB, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Page', 'Affiliation': 'Department of Urology, Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Road, High Heaton, Newcastle upon Tyne, NE7 7DN, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Swami', 'Affiliation': 'NHS Grampian, Department of Urology, Aberdeen Royal Infirmary, Foresterhill, Aberdeen, AB25 2ZN, UK.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Lane', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}]",BJU international,['10.1111/bju.15138']
2751,32558199,Avoidance of CNI and Steroids Using Belatacept - Results of the Clinical Trials in Organ Transplantation 16 Trial.,"Immunosuppression devoid of corticosteroids has been investigated to avoid long term comorbidities. Likewise, alternatives to calcineurin inhibitors have been investigated as a strategy to improve long-term kidney function following transplanion. Costimulatory blockade strategies that include corticosteroids have recently shown promise, despite their higher rates of early acute rejection. We designed a randomized clinical trial utilizing depletional induction therapy to mitigate early rejection risk while limiting calcineurin inhibitors and corticosteroids. This trial, CTOT-16, sought to evaluate novel belatacept-based strategies employing tacrolimus and corticosteroid avoidance. 69 kidney transplant recipients were randomized from 4 US transplant centers comparing a control group of with rabbit antithymocyte globulin (rATG) induction, rapid steroid taper, and maintenance mycophenolate and tacrolimus, to two arms using maintenance belatacept. There were no graft losses but there were 2 deaths in the control group. However, the trial was halted early due to rejection in the belatacept treatment groups. Serious adverse events were similar across groups. While rejection was not uniform in the belatacept maintenance therapy groups, the frequency of rejection limits the practical implementation of this strategy to avoid both calcineurin inhibitors and corticosteroids at this time.",2020,Serious adverse events were similar across groups.,['69 kidney transplant recipients'],"['depletional induction therapy', 'control group of with rabbit antithymocyte globulin (rATG) induction, rapid steroid taper, and maintenance mycophenolate and tacrolimus, to two arms using maintenance belatacept', 'tacrolimus and corticosteroid avoidance', 'calcineurin inhibitors and corticosteroids']","['graft losses', 'Serious adverse events']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0359156', 'cui_str': 'Rabbit anti-human T-lymphocyte globulin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1619962', 'cui_str': 'belatacept'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C1453118', 'cui_str': 'CABIN1 protein, human'}]","[{'cui': 'C0877042', 'cui_str': 'Graft loss'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",69.0,0.102752,Serious adverse events were similar across groups.,"[{'ForeName': 'Roslyn B', 'Initials': 'RB', 'LastName': 'Mannon', 'Affiliation': 'Department of Medicine, Division of Nephrology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Armstrong', 'Affiliation': 'Rho, Durham, North Carolina, USA.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Stock', 'Affiliation': 'Department of Surgery, Division of Transplantation, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Aneesh K', 'Initials': 'AK', 'LastName': 'Mehta', 'Affiliation': 'Emory Transplant Center, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Alton B', 'Initials': 'AB', 'LastName': 'Farris', 'Affiliation': 'Emory Transplant Center, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Watson', 'Affiliation': 'Transplantation Branch, National Institute Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Morrison', 'Affiliation': 'Transplantation Branch, National Institute Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Bridges', 'Affiliation': 'Transplantation Branch, National Institute Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Robien', 'Affiliation': 'Transplantation Branch, National Institute Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Newell', 'Affiliation': 'Emory Transplant Center, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Christian P', 'Initials': 'CP', 'LastName': 'Larsen', 'Affiliation': 'Emory Transplant Center, Emory University School of Medicine, Atlanta, Georgia, USA.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.16152']
2752,32558215,Using Nonparticipant Observation as a Method to Understand Implementation Context in Evidence-Based Practice.,"BACKGROUND


The uptake of evidence-based knowledge in practice is influenced by context. Observations are suggested as a valuable but under-used approach in implementation research for gaining a holistic understanding of contexts.
AIM


The aim of this paper is to demonstrate how data from observations can provide insights about context and evidence use in implementation research.
METHODS


Data were collected over 24 months in a randomised trial with an embedded realist evaluation in 24 nursing homes across four European countries; notes from 183 observations (representing 335 hours) were triangulated with interview transcripts and context survey data (from 357 staff interviews and 725 questionnaire responses, respectively).
RESULTS


Although there were similarities in several elements of context within survey, interview and observation data, the observations provided additional features of the implementation context. In particular, observations demonstrated if and how the resources (staffing and supplies) and leadership (formal and informal, teamwork, and professional autonomy) affected knowledge use and implementation. Further, the observations illuminated the influence of standards and the physical nursing environment on evidence-based practice, and the dynamic interaction between different aspects of context.
LINKING EVIDENCE TO ACTION


Although qualitative observations are resource-intensive, they add value when used with other data collection methods, further enlightening the understanding of the implementation context and how evidence use and sharing are influenced by context elements. Observations can enhance an understanding of the context, evidence use and knowledge-sharing triad in implementation research.",2020,"Although there were similarities in several elements of context within survey, interview and observation data, the observations provided additional features of the implementation context.","['Data were collected over 24\xa0months in a randomised trial with an embedded realist evaluation in 24 nursing homes across four European countries; notes from 183 observations (representing 335 hours) were triangulated with interview transcripts and context survey data (from 357 staff interviews and 725 questionnaire responses, respectively']",[],[],"[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",[],[],,0.0495672,"Although there were similarities in several elements of context within survey, interview and observation data, the observations provided additional features of the implementation context.","[{'ForeName': 'Ann Catrine', 'Initials': 'AC', 'LastName': 'Eldh', 'Affiliation': 'Department of Medicine and Health, Linkoping University, Linkoping, Sweden.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Rycroft-Malone', 'Affiliation': 'Department of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Teatske', 'Initials': 'T', 'LastName': 'van der Zijpp', 'Affiliation': 'Fontys School of People and Health Studies, Fontys University of Applied Sciences, Eindhoven, The Netherlands.'}, {'ForeName': 'Christel', 'Initials': 'C', 'LastName': 'McMullan', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Hawkes', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}]",Worldviews on evidence-based nursing,['10.1111/wvn.12449']
2753,32556710,Resolution of Hydronephrosis in Children with Dysfunctional Voiding After Biofeedback Therapy: A Randomized Clinical Trial.,"We assessed efficacy of biofeedback therapy and home pelvic floor muscle exercises in children with dysfunctional voiding (DV) associated with mild to moderate hydronephrosis. This prospective study comprised fifty seven children (21 boys, 36 girls; mean age 8.9 ± 2.6) with DV and mild to moderate hydronephrosis. Children were randomly allocated into two treatment groups including control group who underwent standard urotherapy and case group who received biofeedback therapy in addition to standard urotherapy. A 99mTc diethylenetriamine pentaacetic acid (99mDTPA) scan, voiding cystoureterography, kidney and bladder ultrasounds, voiding diary and uroflowmetry with electromyography (EMG) were performed in all study participants at the baseline. Children with evidence of complete obstruction in DTPA scan and vesicoureteral reflux were excluded from enrollment. A complete voiding diary, kidney and bladder ultrasounds and uroflowmetry/EMG were also performed 6 months and 1 year after completion of the treatment. We noted a more significant decline in anteroposterior pelvic diameter in case group compared to control group (P < 0.05). The mean maximal urine flow rate prior to treatment was 16.5 ± 2.6 and 16.1 ± 3 ml/s in case and control groups, respectively. This finding increased significantly 1 year after the treatment in case group compared to controls (25 ± 7.2 ml/s vs. 18.4 ± 5.9 ml/s, respectively; P < 0.001). Improvement of various parameters in voiding diary was also more significant in the case group. Biofeedback therapy can effectively resolve non-refluxing and non-obstructive hydronephrosis in children with DV.",2020,Biofeedback therapy can effectively resolve non-refluxing and non-obstructive hydronephrosis in children with DV.,"['Children with Dysfunctional Voiding', 'Children with evidence of complete obstruction in DTPA scan and vesicoureteral reflux', 'children with dysfunctional voiding (DV) associated with mild to moderate hydronephrosis', 'children with DV', 'fifty seven children (21 boys, 36 girls; mean age 8.9\u2009±\u20092.6) with DV and mild to moderate hydronephrosis']","['control group who underwent standard urotherapy and case group who received biofeedback therapy in addition to standard urotherapy', 'Biofeedback Therapy', 'Biofeedback therapy', 'biofeedback therapy and home pelvic floor muscle exercises']","['mean maximal urine flow rate', 'Resolution of Hydronephrosis', 'voiding diary', 'voiding diary, kidney and bladder ultrasounds and uroflowmetry/EMG', '99mTc diethylenetriamine pentaacetic acid (99mDTPA) scan, voiding cystoureterography, kidney and bladder ultrasounds, voiding diary and uroflowmetry with electromyography (EMG', 'anteroposterior pelvic diameter']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0403659', 'cui_str': 'Dysfunctional voiding'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0013254', 'cui_str': 'Pentetic acid'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0042580', 'cui_str': 'Vesicoureteric reflux'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0020295', 'cui_str': 'Hydronephrosis'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517633', 'cui_str': '2.6'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0232851', 'cui_str': 'Flow of urine'}, {'cui': 'C0020295', 'cui_str': 'Hydronephrosis'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0855956', 'cui_str': 'Ultrasound bladder'}, {'cui': 'C0200008', 'cui_str': 'Uroflowmetry'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C1692878', 'cui_str': '99mTc(HYNICtide)(tricine)(TPPTS)'}, {'cui': 'C0013254', 'cui_str': 'Pentetic acid'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}]",57.0,0.0344376,Biofeedback therapy can effectively resolve non-refluxing and non-obstructive hydronephrosis in children with DV.,"[{'ForeName': 'Seyedeh-Sanam', 'Initials': 'SS', 'LastName': 'Ladi-Seyedian', 'Affiliation': ""Pediatric Urology and Regenerative Medicine Research Center, Children's Medical Center, Pediatric Center of Excellence, Tehran University of Medical Sciences, No. 62, Dr. Qarib St, Keshavarz Blvd, 4194 33151, Tehran, Iran.""}, {'ForeName': 'Lida', 'Initials': 'L', 'LastName': 'Sharifi-Rad', 'Affiliation': ""Pediatric Urology and Regenerative Medicine Research Center, Children's Medical Center, Pediatric Center of Excellence, Tehran University of Medical Sciences, No. 62, Dr. Qarib St, Keshavarz Blvd, 4194 33151, Tehran, Iran.""}, {'ForeName': 'Erfan', 'Initials': 'E', 'LastName': 'Amini', 'Affiliation': ""Pediatric Urology and Regenerative Medicine Research Center, Children's Medical Center, Pediatric Center of Excellence, Tehran University of Medical Sciences, No. 62, Dr. Qarib St, Keshavarz Blvd, 4194 33151, Tehran, Iran.""}, {'ForeName': 'Abdol-Mohammad', 'Initials': 'AM', 'LastName': 'Kajbafzadeh', 'Affiliation': ""Pediatric Urology and Regenerative Medicine Research Center, Children's Medical Center, Pediatric Center of Excellence, Tehran University of Medical Sciences, No. 62, Dr. Qarib St, Keshavarz Blvd, 4194 33151, Tehran, Iran. kajbafzd@sina.tums.ac.ir.""}]",Applied psychophysiology and biofeedback,['10.1007/s10484-020-09474-z']
2754,32556730,Using local hemostatic to prevent seromas in patients with large incisional hernias randomized controlled trial.,"PURPOSE


The purpose of the study is to compare the results of single-blind a randomized controlled trial on the use of the local hemostatic agent Haemoblock and ultrasound monitoring of postoperative wounds in patients after the large incisional hernias repair.
METHODS


The study represented a single-blind randomized controlled trial. The total number of patients was 66. Group with Haemoblock (A) and the Group without Haemoblock (B) included 33 patients each. Operation-sublay retromuscular repair with mesh prolene implant. We applied Haemoblock 15 ml retromuscularly and 15 ml subcutaneousely in group A. Wounds were drained by vacuum suction drainage. Postoperatively - ultrasound monitoring of postoperative wounds.
RESULTS


Median of follow-up was 33 days. Significant differences were obtained in the duration of wound draining, 2.6 ± 0.6 days in group A versus 4.1 ± 0.9 days in group B (p = 0.002). In group A, the levels of C-reactive protein and albumin were less in the separated discharge, as well as its total amount. During the first 12 days, a significantly lower volume of fluid collections was detected in patients of group A than in patients of group B. We noted a more rapid subsidence of exudative processes in postoperative wounds in patients from group A. The number of punctures was significantly higher in group B (0.8 ± 1.0 vs. 0.2 ± 0.4, respectively, p = 0.003). The total number of puncture interventions in group A was six in six patients, versus 27 in 14 patients in group B (p = 0.000).
CONCLUSION


The use of the local hemostatic agent Haemoblock can reduce the duration of the postoperative wound draining, shorten the period of inflammatory exudative processes in the postoperative wound, significantly reduce the number of puncture interventions for the postoperative wound, reduce the risk of the seromas formation and surgical site infections (SSI) associated with seroma, reduce the severity of pain and the need for analgesics.",2020,"The total number of puncture interventions in group A was six in six patients, versus 27 in 14 patients in group B (p = 0.000).
","['patients after the large incisional hernias repair', 'patients with large incisional hernias', 'postoperative wounds in patients from group A']","['Haemoblock 15\xa0ml retromuscularly and 15\xa0ml subcutaneousely in group A. Wounds were drained by vacuum suction drainage', 'local hemostatic agent Haemoblock and ultrasound monitoring', 'Operation-sublay retromuscular repair with mesh prolene implant']","['levels of C-reactive protein and albumin', 'volume of fluid collections', 'number of punctures', 'total number of puncture interventions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0342971', 'cui_str': 'Repair of incisional hernia'}, {'cui': 'C0267716', 'cui_str': 'Incisional hernia'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C3653417', 'cui_str': 'Local hemostatics'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0917843', 'cui_str': 'Prolene'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.0747032,"The total number of puncture interventions in group A was six in six patients, versus 27 in 14 patients in group B (p = 0.000).
","[{'ForeName': 'E N', 'Initials': 'EN', 'LastName': 'Degovtsov', 'Affiliation': ""Head of the Department of Hospital Surgery Named After N.S. Makokhi, Russian Federation, Omsk State Medical University of the Ministry of Health of Russia, Lenin's st. 12., Omsk, 644099, Russia.""}, {'ForeName': 'P V', 'Initials': 'PV', 'LastName': 'Kolyadko', 'Affiliation': ""Head of the Department of Hospital Surgery Named After N.S. Makokhi, Russian Federation, Omsk State Medical University of the Ministry of Health of Russia, Lenin's st. 12., Omsk, 644099, Russia. SuperLancet@yandex.ru.""}, {'ForeName': 'V P', 'Initials': 'VP', 'LastName': 'Kolyadko', 'Affiliation': ""Russian Federation, Nizhnevartovsk County Clinical Hospital, Lenin's st. 18, Khanty-Mansi Autonomous Area, Nizhnevartovsk, 628614, Russia.""}]",Hernia : the journal of hernias and abdominal wall surgery,['10.1007/s10029-020-02251-1']
2755,32556749,Neuronavigation based 10 sessions of repetitive transcranial magnetic stimulation therapy in chronic migraine: an exploratory study.,"INTRODUCTION


Chronic migraine is a disease of altered cortical excitability. Repetitive transcranial magnetic stimulation provides a novel non-invasive method to target the nociceptive circuits in the cortex. Motor cortex is one such potential target. In this study, we targeted the left motor cortex using fMRI-guided neuronavigation.
MATERIALS AND METHODS


Twenty right-handed patients were randomized into real and sham rTMS group. Baseline subjective pain assessments were done using visual analog scale (VAS) and questionnaires: State-Trait Anxiety Inventory, Becks Depression Inventory, and Migraine Disability Assessment (MIDAS) questionnaire. Objectively, pain was assessed by means of thermal pain thresholds using quantitative sensory testing. For corticomotor excitability parameters, resting motor thresholds and motor-evoked potentials were mapped. For rTMS total, 600 pulses in 10 trains at 10 Hz with an intertrain interval of 60 s were delivered in each session. Ten such sessions were given 5 days per week over 2 consecutive weeks. The duration of each session was 10 min. Real rTMS was administered at 70% of Resting MT. All the tests were repeated post-intervention and after 1 month of follow-up. There are no studies reporting the use of fMRI-based TMS for targeting the motor cortex in CM patients.
RESULTS


We observed a significant reduction in the mean VAS rating, headache frequency, and MIDAS questionnaire in real rTMS group which was maintained after 1 month of follow-up.
CONCLUSION


Ten sessions of fMRI-based rTMS over the left motor cortex may provide long-term pain relief in CM, but further studies are warranted to confirm our preliminary findings.",2020,"We observed a significant reduction in the mean VAS rating, headache frequency, and MIDAS questionnaire in real rTMS group which was maintained after 1 month of follow-up.
","['Twenty right-handed patients', 'chronic migraine']","['repetitive transcranial magnetic stimulation therapy', 'Real rTMS', 'fMRI-based rTMS', 'Repetitive transcranial magnetic stimulation', 'fMRI-based TMS', 'real and sham rTMS']","['Baseline subjective pain assessments', 'mean VAS rating, headache frequency, and MIDAS questionnaire', 'State-Trait Anxiety Inventory, Becks Depression Inventory, and Migraine Disability Assessment (MIDAS) questionnaire', 'visual analog scale (VAS) and questionnaires', 'Objectively, pain']","[{'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",600.0,0.0287947,"We observed a significant reduction in the mean VAS rating, headache frequency, and MIDAS questionnaire in real rTMS group which was maintained after 1 month of follow-up.
","[{'ForeName': 'Anant', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Department of Physiology, Pain Research and TMS Lab, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Bhawna', 'Initials': 'B', 'LastName': 'Mattoo', 'Affiliation': 'Department of Physiology, Pain Research and TMS Lab, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Bhatia', 'Affiliation': 'Department of Neurology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Senthil', 'Initials': 'S', 'LastName': 'Kumaran', 'Affiliation': 'Department of Nuclear Magnetic Resonance Imaging, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Renu', 'Initials': 'R', 'LastName': 'Bhatia', 'Affiliation': 'Department of Physiology, Pain Research and TMS Lab, All India Institute of Medical Sciences, New Delhi, India. renuaiims28@gmail.com.'}]",Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology,['10.1007/s10072-020-04505-3']
2756,32556764,A prospective randomized comparison of sexual function and semen analysis following laparoscopic totally extraperitoneal (TEP) and transabdominal pre-peritoneal (TAPP) inguinal hernia repair.,"BACKGROUND


With standardization of laparoscopic technique of groin hernia repair, the focus of surgical outcome has shifted to lesser studied parameters like sexual function and fertility.
METHODS


This prospective randomized study was conducted in a single surgical unit at a tertiary care hospital. A sample size of 144 was calculated with 72 in each group (Group 1 TEP and Group 2 TAPP). Primary outcomes measured included comparison of sexual function using BMFSI, qualitative semen analysis and ASA levels between patients undergoing TEP or TAPP repair. Semen analysis and ASA was measured pre-operatively and 3 months post-operatively.
RESULTS


A total of 145 patients were randomized into two groups, TAPP (73) and TEP (72) patients. Both the groups were comparable in terms of demographic profile and hernia characteristics with majority of the patients in both the groups having unilateral inguinal hernia (89.0% in TAPP group and 79.2% in TEP group). Both the groups showed statistically significant improvement in overall sexual function score (BMFSI) at 3 months; however, there was no inter group difference. Both the groups were also comparable in terms of ASA and qualitative semen analysis.
CONCLUSION


Both TEP and TAPP repair are comparable in terms of sexual function and effect on semen analysis. Laparoscopic repair improves the overall sexual functions in patients with groin hernia.",2020,"Both the groups showed statistically significant improvement in overall sexual function score (BMFSI) at 3 months; however, there was no inter group difference.","['73) and TEP (72) patients', '145 patients', 'patients with groin hernia', 'single surgical unit at a tertiary care hospital']","['laparoscopic totally extraperitoneal (TEP) and transabdominal pre-peritoneal (TAPP) inguinal hernia repair', 'TAPP', 'Laparoscopic repair']","['demographic profile and hernia characteristics', 'comparison of sexual function using BMFSI, qualitative semen analysis and ASA levels', 'unilateral inguinal hernia', 'overall sexual function score (BMFSI', 'overall sexual functions']","[{'cui': 'C0145334', 'cui_str': 'tetraethylpyrazine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0442090', 'cui_str': 'Extraperitoneal'}, {'cui': 'C0205496', 'cui_str': 'Abdominal approach'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0163807', 'cui_str': 'tetra-4-amidinophenoxypropane'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0202533', 'cui_str': 'Semen analysis'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",145.0,0.0992969,"Both the groups showed statistically significant improvement in overall sexual function score (BMFSI) at 3 months; however, there was no inter group difference.","[{'ForeName': 'Krishna', 'Initials': 'K', 'LastName': 'Asuri', 'Affiliation': 'Department of Surgical Disciplines, All India Institute of Medical Sciences, New Delhi, India. dr.asurikrishna@gmail.com.'}, {'ForeName': 'Aamir', 'Initials': 'A', 'LastName': 'Mohammad', 'Affiliation': 'Department of Surgical Disciplines, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Om Prakash', 'Initials': 'OP', 'LastName': 'Prajapati', 'Affiliation': 'Department of Surgical Disciplines, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Sagar', 'Affiliation': 'Department of Psychiatry, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Atin', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Department of Radio Diagnosis, All India Institute of Medical Sciences, India, New Delhi.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Sharma', 'Affiliation': 'Department of Reproductive Biology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Pradeep Kumar', 'Initials': 'PK', 'LastName': 'Chaturvedi', 'Affiliation': 'Department of Reproductive Biology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Shardool Vikram', 'Initials': 'SV', 'LastName': 'Gupta', 'Affiliation': 'Department of Surgical Disciplines, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sanjeet Kumar', 'Initials': 'SK', 'LastName': 'Rai', 'Affiliation': 'Department of Surgical Disciplines, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Mahesh Chandra', 'Initials': 'MC', 'LastName': 'Misra', 'Affiliation': 'Mahatma Gandhi University of Medical Science and Technology, Jaipur, India.'}, {'ForeName': 'Virinder Kumar', 'Initials': 'VK', 'LastName': 'Bansal', 'Affiliation': 'Department of Surgical Disciplines, All India Institute of Medical Sciences, New Delhi, India.'}]",Surgical endoscopy,['10.1007/s00464-020-07733-y']
2757,32558044,"Efficacy of levetiracetam on upper limb movement in multiple sclerosis patients with cerebellar signs: a multicenter double-blind, placebo-controlled, crossover study.","BACKGROUND


The literature provides contrasting results on the efficacy of levetiracetam (LEV) in multiple sclerosis (MS) patients with cerebellar signs. We sought to evaluate the efficacy of LEV on upper limb movement in MS patients.
METHODS


In this multicenter double-blind placebo-controlled crossover study, MS patients with prevalently cerebellar signs were randomly allocated into two groups: LEV followed by placebo (Group 1) or placebo followed by LEV (Group 2). Clinical assessments were performed by a blinded physician at T0 (day 1), T1 (day 22), T2 (2-week wash-out period, day 35), and T3 (day 56). The primary outcome was dexterity in the arm with greater deficit, assessed by the nine-hole peg test (9HPT). Secondary clinical outcomes included responders on the 9HPT (∆9HPT>20%), tremor activity of daily living questionnaire and self-defined upper limb impairment, through a numeric rating scale. Kinematic evaluation was performed using a digitizing tablet, providing data on normalized jerk (NJ), aiming error and centripetal acceleration.
RESULTS


Forty-eight subjects (45.2±10.4 years) were randomly allocated into two groups (n=24 each). 9HPT significantly improved in the LEV phase in both groups (p<0.001). The LEV treatment phase lead to a significant improvement (p<0.01) of all clinical outcomes in Group 1 and in dexterity in Group 2. No significant changes were reported during both placebo phases in both groups. Considering the kinematic analysis, only NJ significantly improved after treatment with LEV (T0-T1) in Group 1.
CONCLUSIONS


LEV treatment seems to be effective in improving upper limb dexterity in MS patients with cerebellar signs.",2020,The LEV treatment phase lead to a significant improvement (p<0.01) of all clinical outcomes in Group 1 and in dexterity in Group 2.,"['MS patients with prevalently cerebellar signs', 'Forty-eight subjects (45.2±10.4 years', 'MS patients', 'multiple sclerosis (MS) patients with cerebellar signs', 'MS patients with cerebellar signs', 'multiple sclerosis patients with cerebellar signs']","['levetiracetam', 'levetiracetam (LEV', 'LEV', 'LEV (T0-T1', 'LEV followed by placebo', 'placebo followed by LEV', 'placebo']","['upper limb dexterity', '9HPT', 'dexterity in the arm with greater deficit, assessed by the nine-hole peg test (9HPT', 'upper limb movement', 'responders on the 9HPT (∆9HPT>20%), tremor activity of daily living questionnaire and self-defined upper limb impairment, through a numeric rating scale']","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0451335', 'cui_str': 'Nine hole peg test'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0529009,The LEV treatment phase lead to a significant improvement (p<0.01) of all clinical outcomes in Group 1 and in dexterity in Group 2.,"[{'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Solaro', 'Affiliation': 'Rehabilitation Unit, ""Mons. L. Novarese"" Hospital, Moncrivello, Vercelli, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'de Sire', 'Affiliation': 'Rehabilitation Unit, ""Mons. L. Novarese"" Hospital, Moncrivello, Vercelli, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Messmer Uccelli', 'Affiliation': 'Italian Multiple Sclerosis Research Foundation, Genoa, Italy.'}, {'ForeName': 'Margit', 'Initials': 'M', 'LastName': 'Mueller', 'Affiliation': 'Department of Neurology, ASL 3 , Genovese, Genoa, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Bergamaschi', 'Affiliation': 'Department of Neurology, Neurology Institute ""C. Mondino"", Pavia, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Gasperini', 'Affiliation': 'Neurology Division, San Camillo Hospital, Rome, Italy.'}, {'ForeName': 'Domenico Antonio', 'Initials': 'DA', 'LastName': 'Restivo', 'Affiliation': 'Neurological Unit, ""Garibaldi"" Hospital, Catania, Italy.'}, {'ForeName': 'Maria Rosaria', 'Initials': 'MR', 'LastName': 'Stabile', 'Affiliation': 'Brain Imaging and Neural Dynamics Research Group, San Camillo Hospital IRCCS, Venice, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Patti', 'Affiliation': 'Department of Medical, Surgical Science and Advanced Technology ""GF Ingrassia"", University of Catania, Catania, Italy.'}]",European journal of neurology,['10.1111/ene.14403']
2758,32558226,The use of a Bluetooth tablet-based technology to improve outcomes in lung transplantation: A pilot study.,"The impact of remote patient monitoring platforms to support the post-operative care of solid organ transplant recipients is evolving. In an observational pilot study, 28 lung transplant recipients were enrolled in a novel post-discharge home monitoring program and compared to 28 matched controls during a two-year period. Primary endpoints included hospital readmissions and total days readmitted. Secondary endpoints were survival and inflation-adjusted hospital readmission charges. In univariate analyses, monitoring was associated with reduced readmissions (IRR: 0.56; 95% CI: 0.41 - 0.76; p < 0.001), days readmitted (IRR: 0.46; 95% CI: 0.42 - 0.51; p < 0.001), and hospital charges (IRR: 0.52; 95% CI: 0.51 - 0.54; p < 0.001). Multivariate analyses also showed that remote monitoring was associated with lower incidence of readmission (IRR: 0.38; 95% CI: 0.23 - 0.63; p < 0.001), days readmitted (IRR: 0.14; 95% CI: 0.05 - 0.37; p < 0.001), and readmission charges (IRR: 0.11; 95% CI: 0.03 - 0.46; p = 0.002). There were 2 deaths among monitored patients compared to 6 for controls; however, this difference was not significant. This pilot study in lung transplant recipients suggests that supplementing post-discharge care with remote monitoring may be useful in preventing readmissions, reducing subsequent inpatient days, and controlling hospital charges. A multicenter, randomized control trial should be conducted to validate these findings.",2020,"In univariate analyses, monitoring was associated with reduced readmissions (IRR: 0.56; 95% CI: 0.41 - 0.76; p < 0.001), days readmitted (IRR: 0.46; 95% CI: 0.42 - 0.51; p < 0.001), and hospital charges (IRR: 0.52; 95% CI: 0.51 - 0.54; p < 0.001).","['lung transplant recipients', '28 lung transplant recipients were enrolled in a novel post-discharge home monitoring program and compared to 28 matched controls during a two-year period', 'lung transplantation']",['Bluetooth tablet-based technology'],"['hospital charges', 'survival and inflation-adjusted hospital readmission charges', 'incidence of readmission', 'hospital readmissions and total days readmitted', 'readmission charges']","[{'cui': 'C0024128', 'cui_str': 'Transplant of lung'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0206175', 'cui_str': 'Charge, Hospital'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0021398', 'cui_str': 'Economic Inflation'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.0472527,"In univariate analyses, monitoring was associated with reduced readmissions (IRR: 0.56; 95% CI: 0.41 - 0.76; p < 0.001), days readmitted (IRR: 0.46; 95% CI: 0.42 - 0.51; p < 0.001), and hospital charges (IRR: 0.52; 95% CI: 0.51 - 0.54; p < 0.001).","[{'ForeName': 'Felicia A', 'Initials': 'FA', 'LastName': 'Schenkel', 'Affiliation': 'Keck Medical Center of University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Barr', 'Affiliation': 'Division of Cardiothoracic Surgery, Department of Surgery, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'C Christopher', 'Initials': 'CC', 'LastName': 'McCloskey', 'Affiliation': 'ActiCare Health, Livermore, California, USA.'}, {'ForeName': 'Tammie', 'Initials': 'T', 'LastName': 'Possemato', 'Affiliation': 'Keck Medical Center of University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': ""O'Conner"", 'Affiliation': 'Keck Medical Center of University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Sadeghi', 'Affiliation': 'Keck Medical Center of University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Bembi', 'Affiliation': 'Keck Medical Center of University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Duong', 'Affiliation': 'Keck Medical Center of University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Jaynita', 'Initials': 'J', 'LastName': 'Patel', 'Affiliation': 'Keck Medical Center of University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Hackmann', 'Affiliation': 'Division of Cardiothoracic Surgery, Department of Surgery, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Sivagini', 'Initials': 'S', 'LastName': 'Ganesh', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Southern California, Los Angeles, California, USA.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.16154']
2759,32558287,Heart failure patients with atrial fibrillation benefit from remote patient management: insights from the TIM-HF2 trial.,"AIMS


Atrial fibrillation (AF) is a frequent comorbidity in patients with heart failure (HF). HF patients with AF are characterized by high morbidity and increased risk of hospitalizations. We assessed the effects of remote patient management (RPM) in HF patients with AF compared with usual care (UC) in the TIM-HF2 trial.
METHODS AND RESULTS


For this post-hoc analysis, AF status at randomization was assessed in 1537 patients with HF. The primary outcome was the percentage of days lost due to unplanned cardiovascular hospital admissions or death of any cause. Around 966 patients had sinus rhythm (SR) and 571 had AF. The analysis showed a significant interaction between heart rhythm and all-cause mortality (P for interaction = 0.001). AF patients had more days lost due to unplanned cardiovascular hospitalization than SR patients (7.53%, CI 6.01-9.05 vs. 4.90%, CI 3.98-5.82, ratio 1.54, P = 0.004) and higher all-cause mortality (11.9%, CI 9.4-14.9 vs. 8.5%, CI 6.8-10.4, HR 0.66, CI 0.47-0.94, P = 0.029). Patients with AF randomized to RPM had significantly less days lost due to unplanned cardiovascular hospital admissions or all-cause death (5.64%, CI 3.81-7.48) than patients with AF randomized to UC (9.37%, CI 6.98-11.76, ratio 0.60, P = 0.015). No difference was seen in SR patients (UC: 5.25%, CI 3.93-6.58, RPM: 4.55%, CI 3.27-5.83, ratio 0.87, P = 0.452). All-cause mortality in AF patients was reduced with 9.2% (CI 6.1-13.2) in the RPM group compared with 14.5% (CI 10.7-18.1) in the UC group (HR 0.60, CI 0.36-1.00, P = 0.050).
CONCLUSIONS


For patients with atrial fibrillation at study entry, RPM was associated with increased days alive out of hospital. Our results identify HF patients with atrial fibrillation as a promising target population for RPM.",2020,The analysis showed a significant interaction between heart rhythm and all-cause mortality (P for interaction = 0.001).,"['966 patients had sinus rhythm (SR) and 571 had AF', '1537 patients with HF', 'HF patients with AF', 'Heart failure patients with atrial fibrillation benefit from remote patient management', 'HF patients with atrial fibrillation', 'HF patients with AF compared with usual care (UC) in the TIM-HF2 trial', 'patients with heart failure (HF']","['RPM', 'remote patient management (RPM']","['unplanned cardiovascular hospital admissions or all-cause death', 'unplanned cardiovascular hospitalization', 'heart rhythm and all-cause mortality', 'risk of hospitalizations', 'cause mortality', 'percentage of days lost due to unplanned cardiovascular hospital admissions or death of any cause']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0429928', 'cui_str': 'Test time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0232187', 'cui_str': 'Cardiac rhythm type'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",1537.0,0.132013,The analysis showed a significant interaction between heart rhythm and all-cause mortality (P for interaction = 0.001).,"[{'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Stegmann', 'Affiliation': 'Clinic and Policlinic for Cardiology, University Hospital Leipzig, Liebigstraße 20, Leipzig, 04103, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Koehler', 'Affiliation': 'Centre for Cardiovascular Telemedicine, Department of Cardiology and Angiology at Campus Mitte, Charité-Universitätsmedizin-Berlin, Berlin, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Wachter', 'Affiliation': 'Clinic and Policlinic for Cardiology, University Hospital Leipzig, Liebigstraße 20, Leipzig, 04103, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Moeller', 'Affiliation': 'Centre for Cardiovascular Telemedicine, Department of Cardiology and Angiology at Campus Mitte, Charité-Universitätsmedizin-Berlin, Berlin, Germany.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Zeynalova', 'Affiliation': 'Institute for Medical Informatics, Statistics and Epidemiology, (IMISE), University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Friedrich', 'Initials': 'F', 'LastName': 'Koehler', 'Affiliation': 'Centre for Cardiovascular Telemedicine, Department of Cardiology and Angiology at Campus Mitte, Charité-Universitätsmedizin-Berlin, Berlin, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Laufs', 'Affiliation': 'Clinic and Policlinic for Cardiology, University Hospital Leipzig, Liebigstraße 20, Leipzig, 04103, Germany.'}]",ESC heart failure,['10.1002/ehf2.12819']
2760,32558298,Colchicine Prophylaxis of Gout Flares When Commencing Allopurinol is Very Cost Effective.,"OBJECTIVE


Colchicine prophylaxis to prevent gout flares when commencing urate lowering therapy is recommended by international rheumatology society guidelines. Whether this is a cost-effective intervention is currently unknown. Our objective was to perform a cost effectiveness analysis using both a United States cost input model and an Australian cost input model.
METHODS


This cost-effectiveness analysis was completed from the point of view of the third-party payer. We used a two-arm decision-tree with one arm commencing allopurinol with no colchicine prophylaxis and the other with colchicine prophylaxis. Model inputs were drawn from published literature, where available. We completed univariate and probabilistic sensitivity analysis to confirm the robust nature of the modelling. The time frame for the model was 6 months.
RESULTS


The colchicine prophylaxis arm resulted in a cost of US$1276 and 0.49 quality adjusted life-years (QALYs) while in the placebo arm the cost was US$516 and 0.47 QALYs, with an incremental cost-effectiveness ratio of US$34,004 per QALY gained. In Australia where cost of colchicine was much lower, the colchicine arm dominated the placebo (A$208 in colchicine arm vs. A$415 in placebo). Univariate and probability sensitivity analysis demonstrated that results were robust to changes in input parameters. In probabilistic sensitivity analysis, the probability of colchicine prophylaxis being the most cost-effective option was 93% in the United States and 100% in Australian setting.
CONCLUSION


Colchicine prophylaxis to prevent gout flares whilst commencing allopurinol in gout is very cost effective.",2020,"The colchicine prophylaxis arm resulted in a cost of US$1276 and 0.49 quality adjusted life-years (QALYs) while in the placebo arm the cost was US$516 and 0.47 QALYs, with an incremental cost-effectiveness ratio of US$34,004 per QALY gained.",['Gout Flares'],"['colchicine prophylaxis', 'Colchicine', 'placebo', 'allopurinol', 'colchicine', 'allopurinol with no colchicine prophylaxis', 'Colchicine prophylaxis', 'Allopurinol']",['cost of US$1276 and 0.49 quality adjusted life-years (QALYs'],"[{'cui': 'C0149896', 'cui_str': 'Primary gout'}]","[{'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002144', 'cui_str': 'Allopurinol'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",,0.0717032,"The colchicine prophylaxis arm resulted in a cost of US$1276 and 0.49 quality adjusted life-years (QALYs) while in the placebo arm the cost was US$516 and 0.47 QALYs, with an incremental cost-effectiveness ratio of US$34,004 per QALY gained.","[{'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Robinson', 'Affiliation': ""Royal Brisbane & Women's Hospital, Brisbane, Australia.""}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Dalbeth', 'Affiliation': 'Faculty of Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Donovan', 'Affiliation': ""Royal Brisbane & Women's Hospital, Brisbane, Australia.""}]",Arthritis care & research,['10.1002/acr.24357']
2761,32558305,Effect of preoperative topical nepafenac 0.1% on inflammatory response after uncomplicated cataract surgery in healthy subjects.,"PURPOSE


To determine the effect of preoperative topical Nepafenac administration on anterior chamber flare after uneventful cataract surgery in healthy subjects.
METHODS


Prospective randomized clinical trial. Seventy-three eyes of 73 healthy patients undergoing routine cataract surgery were randomized to receive (group A) topical nepafenac (1 mg/ml) or not to receive (group B) 1 drop 3 times per day for 3 days before surgery. All eyes received the same postoperative anti-inflammatory therapy. Clinical outcome parameters such as best corrected visual acuity, intraocular pressure, retinal central foveal thickness and aqueous flare were recorded preoperatively, 1, 15, 30 and 60 days after surgery.
RESULTS


Three patients were excluded for poor compliance, and three patients were excluded or developing pseudophakic macular oedema during the follow-up. Both groups were comparable for age, gender, and showed similar BCVA, intraocular pressure and central macular thickness values preoperatively and during the entire follow-up (p > 0.01). Aqueous flare values showed a statistically increase in both groups respect to preoperative values through follow-up evaluations (p < 0.01), while values were significantly lower in group A than in group B 30 days after surgery (p < 0.01).
CONCLUSION


Preoperative administration of topical Nepafenac reduces the inflammatory response in healthy patients undergoing uncomplicated cataract surgery one month after surgery respect to non-treated group.",2020,"Aqueous flare values showed a statistically increase in both groups respect to preoperative values through follow-up evaluations (p < 0.01), while values were significantly lower in group A than in group B 30 days after surgery (p < 0.01).
","['uncomplicated cataract surgery in healthy subjects', 'healthy patients undergoing uncomplicated cataract surgery one month after surgery respect to non-treated group', 'Seventy-three eyes of 73 healthy patients undergoing routine cataract surgery', 'anterior chamber flare after uneventful cataract surgery in healthy subjects']","['preoperative topical Nepafenac', 'topical nepafenac', 'preoperative topical nepafenac', 'topical Nepafenac']","['corrected visual acuity, intraocular pressure, retinal central foveal thickness and aqueous flare', 'BCVA, intraocular pressure and central macular thickness values', 'inflammatory response', 'pseudophakic macular oedema']","[{'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0423281', 'cui_str': 'Anterior chamber flare'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0961209', 'cui_str': 'nepafenac'}]","[{'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0423281', 'cui_str': 'Anterior chamber flare'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}]",73.0,0.0386449,"Aqueous flare values showed a statistically increase in both groups respect to preoperative values through follow-up evaluations (p < 0.01), while values were significantly lower in group A than in group B 30 days after surgery (p < 0.01).
","[{'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Cagini', 'Affiliation': 'Department of Biomedical and Surgical Sciences, Ophthalmology Section, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Cerquaglia', 'Affiliation': 'Department of Biomedical and Surgical Sciences, Ophthalmology Section, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Pellegrino', 'Affiliation': 'Department of Biomedical and Surgical Sciences, Ophthalmology Section, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Iannone', 'Affiliation': 'Department of Biomedical and Surgical Sciences, Ophthalmology Section, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Lupidi', 'Affiliation': 'Department of Biomedical and Surgical Sciences, Ophthalmology Section, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Tito', 'Initials': 'T', 'LastName': 'Fiore', 'Affiliation': 'Department of Biomedical and Surgical Sciences, Ophthalmology Section, University of Perugia, Perugia, Italy.'}]",Acta ophthalmologica,['10.1111/aos.14513']
2762,32558314,Four-day plaque regrowth evaluation of a peptide chewing gum in a double-blind randomized clinical trial.,"OBJECTIVE


Antimicrobial peptide, KSL-W, formulated as an antiplaque chewing gum (APCG), was tested to evaluate the dental plaque inhibition activity and safety in an IRB approved and FDA regulated 4-day plaque regrowth clinical study.
METHODS


This Phase 2 two-armed placebo-controlled, double blind, randomized (1:1), multiple dose, and single-center study was evaluated in a proof of concept for the APCG containing 30 mg antimicrobial peptide KSL-W. Twenty six generally healthy subjects were consented and randomized into the study. The subjects were administered a dose three times per day for four treatment days following a complete dental prophylaxis. Participants were prohibited from conducting oral hygiene care (teeth brushing, flossing, and/or mouth wash rinse) for the duration of the trial. Twelve to 16 hr prior to the baseline visit, the subjects were to abstain from oral hygiene care. The Quigley-Hein Turesky plaque index (QHT) score and the oral soft tissue clinical exams were obtained at both Day 0 and Day 4.
RESULTS


All randomized study subjects that received either APCG or placebo gum completed the study with no significant adverse events recorded. The APCG significantly inhibited the regrowth of dental plaque over the course of 4 days. The whole mouth data demonstrated a difference in the QHT between the APCG and the placebo gum of 1.14 (SE = 0.27) and 95% confidence bounds of 0.58, 1.70 with a two-tailed P value of .0003.
CONCLUSION


Considering the limited sample size, the proof of concept analysis in this Phase 2 study confirmed that APCG is effective against dental plaque formation and safe for human use. (ClinicalTrials.gov Study ID# NCT02864901).",2020,"The whole mouth data demonstrated a difference in the QHT between the APCG and the placebo gum of 1.14 (SE = 0.27) and 95% confidence bounds of 0.58, 1.70 with a two-tailed P value of .0003.
","['W. Twenty six generally healthy subjects', 'Participants were prohibited from conducting oral hygiene care (teeth brushing, flossing, and/or mouth wash rinse) for the duration of the trial']","['APCG', 'APCG or placebo', 'peptide chewing gum', 'APCG containing 30\u2009mg antimicrobial peptide KSL', 'placebo']","['QHT', 'Quigley-Hein Turesky plaque index (QHT) score and the oral soft tissue clinical exams', 'regrowth of dental plaque']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0008037', 'cui_str': 'Chewing Gum'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0447424', 'cui_str': 'Oral soft tissues structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}]",26.0,0.308301,"The whole mouth data demonstrated a difference in the QHT between the APCG and the placebo gum of 1.14 (SE = 0.27) and 95% confidence bounds of 0.58, 1.70 with a two-tailed P value of .0003.
","[{'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Kirkwood', 'Affiliation': 'Dental and Craniofacial Trauma, US Army Institute of Surgical Research, San Antonio, Texas.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': 'ClinSmart LLC, Newton, Pennsylvania.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Milleman', 'Affiliation': 'Salus Research, Inc., Fort Wayne, Indiana.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Milleman', 'Affiliation': 'Salus Research, Inc., Fort Wayne, Indiana.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Leung', 'Affiliation': 'Dental and Craniofacial Trauma, US Army Institute of Surgical Research, San Antonio, Texas.'}]",Clinical and experimental dental research,['10.1002/cre2.275']
2763,32558330,Associations of telomere length with two dietary quality indices after a lifestyle intervention in children with abdominal obesity: a randomized controlled trial.,"BACKGROUND


Dietary factors seem to influence telomere length. Moreover, associations between changes in adiposity indices and telomere length (TL) have been found in intervention studies.
OBJECTIVE


We evaluated changes in two diet quality indices and their association with TL in children with abdominal obesity in a 12-month lifestyle intervention.
METHODS


Eighty-seven participants (7-16 years old) were assigned to the intervention (moderate hypocaloric Mediterranean diet) or usual care group (standard paediatric recommendations) for a 2-month intensive phase and a subsequent 10-month follow-up. Diet quality was assessed using the Diet Quality Index for Adolescents (DQI-A) and the Healthy Lifestyle Diet Index (HLD-I). TL was measured by monochrome multiplex real-time quantitative PCR. The intra-class correlation coefficient for TL was 0.793 (95% CI 0.707, 0.857).
RESULTS


After a 12-month lifestyle intervention, a significant reduction in BMI-SDS (-0.57 and -0.49 for the intervention and usual care groups, respectively) and fat mass was observed in all subjects without differences between groups. Changes in DQI-A (+12.36% vs +5.53%, P = .005) and HLD-I (+4.43 vs +1.09, P < .001) were higher in the intervention subjects compared with usual care subjects after 2 months. Interestingly, we observed a positive change in TL between 2 and 12 months (P = .025), which was associated with higher scores on the DQI-A (β = 0.008, R 2  = 0.088, P = .010) and HLD-I (β = 0.022, R 2  = 0.198, P = .015), in the intervention group after the 2-month intensive phase.
CONCLUSION


Favourable changes in diet quality indices could contribute to telomere integrity in children with abdominal obesity enrolled in an intensive lifestyle intervention.",2020,"Changes in DQI-A (+12.36% vs +5.53%, P = .005) and HLD-I (+4.43 vs +1.09, P < .001) were higher in the intervention subjects compared with usual care subjects after 2 months.","['children with abdominal obesity in a 12-month lifestyle intervention', 'Eighty-seven participants (7-16\u2009years old', 'children with abdominal obesity', 'children with abdominal obesity enrolled in an intensive lifestyle intervention']","['intervention (moderate hypocaloric Mediterranean diet) or usual care group (standard paediatric recommendations', 'lifestyle intervention']","['Changes in DQI-A', 'Diet quality', 'BMI-SDS', 'Diet Quality Index for Adolescents (DQI-A) and the Healthy Lifestyle Diet Index (HLD-I', 'fat mass', 'TL', 'adiposity indices and telomere length (TL', 'positive change in TL']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517895', 'cui_str': '87'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",87.0,0.0350398,"Changes in DQI-A (+12.36% vs +5.53%, P = .005) and HLD-I (+4.43 vs +1.09, P < .001) were higher in the intervention subjects compared with usual care subjects after 2 months.","[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ojeda-Rodríguez', 'Affiliation': 'Department of Nutrition, Food Sciences and Physiology, University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Morell-Azanza', 'Affiliation': 'Department of Nutrition, Food Sciences and Physiology, University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Zalba', 'Affiliation': 'IdiSNA, Instituto de Investigación Sanitaria de Navarra, Pamplona, Spain.'}, {'ForeName': 'Itziar', 'Initials': 'I', 'LastName': 'Zazpe', 'Affiliation': 'Department of Nutrition, Food Sciences and Physiology, University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Azcona-Sanjulian', 'Affiliation': 'IdiSNA, Instituto de Investigación Sanitaria de Navarra, Pamplona, Spain.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Marti', 'Affiliation': 'Department of Nutrition, Food Sciences and Physiology, University of Navarra, Pamplona, Spain.'}]",Pediatric obesity,['10.1111/ijpo.12661']
2764,32558416,Evaluating the effects of different doses of ursodeoxycholic acid on neonatal jaundice.,"BACKGROUND


Icterus tends to be one of the most prevalent causes of neonatal hospitalization. The present study aimed to evaluate the effects of the different doses of ursodeoxycholic acid (UDCA) on neonatal jaundice.
METHOD


In this study, 120 newborns who were hospitalized for phototherapy were randomly assigned. Group A received phototherapy and UDCA 5 mg/kg/dose every 12 hours orally, group B patients were treated with phototherapy and UDCA 7.5 mg/kg/dose every 12 hours orally. Group C received phototherapy with a placebo. All patients were evaluated for bilirubin levels, the duration of phototherapy, and the length of hospital stay.
RESULTS


The mean bilirubin level at hospital admission was 19.88 ± 2.33 mg/dl in group A, 19.33 ± 2.51 mg/ dl in group B, and 19.76 ± 2.64 mg/dl in group C (p= 0.58). The groups receiving phototherapy with UDCA showed a significant decrease in the bilirubin level. Bilirubin level decreased to 10.04 ± 1.11mg/dl in group A, 8.82 ± 1.11 mg/dl in group B, and 12.04 ± 2.05 mg/dl in group C (p= 0.000). Furthermore, the mean duration of phototherapy, as well as the average length of hospital stay, were significantly lower in group B as compared to the other groups (p= 0.000).
CONCLUSION


The findings of this study indicated that the administration of UDCA in addition to phototherapy could effectively decrease the length of hospital stay and bilirubin levels in neonatal hyperbilirubinemia. However, further studies with a larger sample size are required before one can recommend the routine use of UDCA for the treatment of neonatal jaundice.",2020,"Bilirubin level decreased to 10.04 ± 1.11mg/dl in group A, 8.82 ± 1.11 mg/dl in group B, and 12.04 ± 2.05 mg/dl in group C (p= 0.000).","['120 newborns who were hospitalized for phototherapy', 'neonatal hyperbilirubinemia']","['ursodeoxycholic acid (UDCA', 'phototherapy with UDCA', 'UDCA', 'phototherapy and UDCA', 'phototherapy with a placebo', 'ursodeoxycholic acid']","['neonatal jaundice', 'mean duration of phototherapy', 'bilirubin levels, the duration of phototherapy, and the length of hospital stay', 'bilirubin level', 'length of hospital stay and bilirubin levels', 'Bilirubin level', 'mean bilirubin level at hospital admission', 'average length of hospital stay']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0857007', 'cui_str': 'Neonatal hyperbilirubinemia'}]","[{'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0022353', 'cui_str': 'Neonatal jaundice'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0344395', 'cui_str': 'Bilirubin measurement'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",120.0,0.0223007,"Bilirubin level decreased to 10.04 ± 1.11mg/dl in group A, 8.82 ± 1.11 mg/dl in group B, and 12.04 ± 2.05 mg/dl in group C (p= 0.000).","[{'ForeName': 'Manizheh Mostafa', 'Initials': 'MM', 'LastName': 'Gharehbaghi', 'Affiliation': ""Woman's Reproductive Health Research Center.""}, {'ForeName': 'Afsaneh Mokhallegh', 'Initials': 'AM', 'LastName': 'Sani', 'Affiliation': 'Department of Pediatrics, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mandana', 'Initials': 'M', 'LastName': 'Refeey', 'Affiliation': 'Liver and Gastrointestinal Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",The Turkish journal of pediatrics,['10.24953/turkjped.2020.03.009']
2765,32558469,Systematic or Test-Guided Treatment for Tuberculosis in HIV-Infected Adults.,"BACKGROUND


In regions with high burdens of tuberculosis and human immunodeficiency virus (HIV), many HIV-infected adults begin antiretroviral therapy (ART) when they are already severely immunocompromised. Mortality after ART initiation is high in these patients, and tuberculosis and invasive bacterial diseases are common causes of death.
METHODS


We conducted a 48-week trial of empirical treatment for tuberculosis as compared with treatment guided by testing in HIV-infected adults who had not previously received ART and had CD4+ T-cell counts below 100 cells per cubic millimeter. Patients recruited in Ivory Coast, Uganda, Cambodia, and Vietnam were randomly assigned in a 1:1 ratio to undergo screening (Xpert MTB/RIF test, urinary lipoarabinomannan test, and chest radiography) to determine whether treatment for tuberculosis should be started or to receive systematic empirical treatment with rifampin, isoniazid, ethambutol, and pyrazinamide daily for 2 months, followed by rifampin and isoniazid daily for 4 months. The primary end point was a composite of death from any cause or invasive bacterial disease within 24 weeks (primary analysis) or within 48 weeks after randomization.
RESULTS


A total of 522 patients in the systematic-treatment group and 525 in the guided-treatment group were included in the analyses. At week 24, the rate of death from any cause or invasive bacterial disease (calculated as the number of first events per 100 patient-years) was 19.4 with systematic treatment and 20.3 with guided treatment (adjusted hazard ratio, 0.95; 95% confidence interval [CI], 0.63 to 1.44). At week 48, the corresponding rates were 12.8 and 13.3 (adjusted hazard ratio, 0.97 [95% CI, 0.67 to 1.40]). At week 24, the probability of tuberculosis was lower with systematic treatment than with guided treatment (3.0% vs. 17.9%; adjusted hazard ratio, 0.15; 95% CI, 0.09 to 0.26), but the probability of grade 3 or 4 drug-related adverse events was higher with systematic treatment (17.4% vs. 7.2%; adjusted hazard ratio 2.57; 95% CI, 1.75 to 3.78). Serious adverse events were more common with systematic treatment.
CONCLUSIONS


Among severely immunosuppressed adults with HIV infection who had not previously received ART, systematic treatment for tuberculosis was not superior to test-guided treatment in reducing the rate of death or invasive bacterial disease over 24 or 48 weeks and was associated with more grade 3 or 4 adverse events. (Funded by the Agence Nationale de Recherches sur le Sida et les Hépatites Virales; STATIS ANRS 12290 ClinicalTrials.gov number, NCT02057796.).",2020,"The primary end point was a composite of death from any cause or invasive bacterial disease within 24 weeks (primary analysis) or within 48 weeks after randomization.
","['severely immunosuppressed adults with HIV infection who had not previously received ART, systematic treatment for tuberculosis', 'In regions with high burdens of tuberculosis and human immunodeficiency virus (HIV', 'Patients recruited in Ivory Coast, Uganda, Cambodia, and Vietnam', '522 patients in the systematic-treatment group and 525 in the guided-treatment group were included in the analyses', 'HIV-infected adults who had not previously received ART and had CD4+ T-cell counts below 100 cells per cubic millimeter', 'Tuberculosis in HIV-Infected Adults']","['undergo screening (Xpert MTB/RIF test, urinary lipoarabinomannan test, and chest radiography', 'rifampin, isoniazid, ethambutol, and pyrazinamide daily for 2 months, followed by rifampin and isoniazid daily for 4 months', 'antiretroviral therapy (ART']","['rate of death from any cause or invasive bacterial disease', 'probability of tuberculosis', 'composite of death from any cause or invasive bacterial disease', 'Mortality', 'rate of death or invasive bacterial disease', 'probability of grade 3 or 4 drug-related adverse events', 'Serious adverse events']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022326', 'cui_str': 'Ivory Coast'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0006797', 'cui_str': 'Cambodia'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C4517804', 'cui_str': '522'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C1300557', 'cui_str': '/mm3'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0026926', 'cui_str': 'Mycobacterium tuberculosis'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0065041', 'cui_str': 'lipoarabinomannan'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0014964', 'cui_str': 'Ethambutol'}, {'cui': 'C0034239', 'cui_str': 'Pyrazinamide'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0004623', 'cui_str': 'Bacterial infectious disease'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.424958,"The primary end point was a composite of death from any cause or invasive bacterial disease within 24 weeks (primary analysis) or within 48 weeks after randomization.
","[{'ForeName': 'François-Xavier', 'Initials': 'FX', 'LastName': 'Blanc', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': 'Anani D', 'Initials': 'AD', 'LastName': 'Badje', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': 'Maryline', 'Initials': 'M', 'LastName': 'Bonnet', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Gabillard', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': 'Eugène', 'Initials': 'E', 'LastName': 'Messou', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': 'Conrad', 'Initials': 'C', 'LastName': 'Muzoora', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': 'Sovannarith', 'Initials': 'S', 'LastName': 'Samreth', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': 'Bang D', 'Initials': 'BD', 'LastName': 'Nguyen', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Borand', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': 'Anaïs', 'Initials': 'A', 'LastName': 'Domergue', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Rapoud', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': 'Naome', 'Initials': 'N', 'LastName': 'Natukunda', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': 'Sopheak', 'Initials': 'S', 'LastName': 'Thai', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Juchet', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': 'Serge P', 'Initials': 'SP', 'LastName': 'Eholié', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Lawn', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': 'Serge K', 'Initials': 'SK', 'LastName': 'Domoua', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Anglaret', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Laureillard', 'Affiliation': ""From the Department of Respiratory Medicine, L'Institut du Thorax, Nantes University Hospital, and the Medical School, University of Nantes, Nantes (F.-X.B.), INSERM Unité 1219, University of Bordeaux, Bordeaux (A.D.B., D.G., X.A.), Relations Translationnelles sur le VIH et les Maladies Infectieuses, Institut de Recherche pour le Développement, University of Montpellier, INSERM (M.B.), and Research Unit 1058 Pathogenesis and Control Chronical Infections, INSERM, French Blood Center, University of Montpellier (D.L.), Montpellier, and the Department of Infectious and Tropical Diseases, Nîmes University Hospital, Nîmes (D.L.) - all in France; Programme ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Coopération Côte d'Ivoire, ANRS research site (A.D.B., E.M., S.J.), and Félix Houphouët-Boigny University (S.P.E., S.K.D.) - both in Abidjan, Ivory Coast; Epicentre (M.B., N.N.) and Mbarara University of Science and Technology (C.M.) - both in Mbarara, Uganda; the National Center for HIV/AIDS, Dermatology, and Sexually Transmitted Diseases (S.S.), Institut Pasteur du Cambodge (L.B.), and Sihanouk Hospital Center of Hope (S.T.) - all in Phnom Penh, Cambodia; Pham Ngoc Thach Hospital (B.D.N.) and ANRS, Pham Ngoc Thach Hospital (A.D., D.R.), Ho Chi Minh City, Vietnam; and the Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London (S.D.L.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1910708']
2766,32551111,Thromboangiitis obliterans: Aggressive angioplasty provides a potential solution (randomized pilot study).,"Background


Thromboangiitis obliterans is an inflammatory disease affecting both medium- and small-sized vessels. Vasodilators, antiplatelets were proposed for treatment but the effect was minimal.
Objective


This study was conducted to investigate the effect of balloon angioplasty on patients with Buerger's disease compared to medical treatment.
Methods


Between January 2006 and December 2016, 82 patients with Buerger's disease were enrolled in the study, of whom 52 were randomized to the aggressive endovascular intervention and 30 were randomized medically by cilostazol and aspirin as a control group. In all, 23% of the patients presented with severe claudication, 50% with ischemic rest pain and 27% with ischemic ulcers. Randomization was done using the opaque envelope method. Allocation concealment was maintained to ensure no selection bias. Patient groups were compared for the duration of ulcer healing, ankle-brachial index, peak systolic velocity changes and transcutaneous oximetry (TcPO2) level for 30 months.
Results


No major procedural complications occurred in the endovascular group. Angiographic success was achieved in 100% of supragenicular lesions but in 90% of infrapopliteal lesions. The endovascular group showed a statistically significant improvement in the ulcer healing size and duration at 6 months after the procedure with a mean time of 3 ± 0.9 months compared to 5.8 ± 1.69 months for the medical treatment group (p < 0.001), the mean TcPO2 from 27.23 ± 16.75 mm Hg (range: 0-56 mm Hg) before the procedure to 71.32 ± 12.94 mm Hg (range: 52-92 mm Hg) following revascularization (p < 0.01). The mean ankle-brachial index significantly improved from 0.54 ± 0.14 preoperatively to 0.82 ± 0.08 at final follow-up (p < 0.01).
Conclusion


The endovascular therapy should be considered as an effective, safe, minimally invasive method in the light of the promising results after a modification of the standard technique.",2020,Angiographic success was achieved in 100% of supragenicular lesions but in 90% of infrapopliteal lesions.,"[""Methods\n\n\nBetween January 2006 and December 2016, 82 patients with Buerger's disease were enrolled in the study, of whom 52 were randomized to the"", ""patients with Buerger's disease compared to medical treatment""]","['balloon angioplasty', 'cilostazol and aspirin', 'aggressive endovascular intervention']","['mean ankle-brachial index', 'mean TcPO2', 'ischemic rest pain', 'ulcer healing size and duration', 'procedural complications', 'Angiographic success', 'severe claudication', 'duration of ulcer healing, ankle-brachial index, peak systolic velocity changes and transcutaneous oximetry (TcPO2) level']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040021', 'cui_str': 'Thromboangiitis obliterans'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0002996', 'cui_str': 'Balloon Angioplasty'}, {'cui': 'C0055729', 'cui_str': 'cilostazol'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0411282', 'cui_str': 'Endovascular radiological intervention'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1328319', 'cui_str': 'Ankle brachial pressure index'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0333293', 'cui_str': 'Healing ulcer'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1141861', 'cui_str': 'Procedural complication'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0021775', 'cui_str': 'Intermittent claudication'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040656', 'cui_str': 'Oxygen Partial Pressure Determination, Transcutaneous'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",82.0,0.0299323,Angiographic success was achieved in 100% of supragenicular lesions but in 90% of infrapopliteal lesions.,"[{'ForeName': 'Mosaad', 'Initials': 'M', 'LastName': 'Soliman', 'Affiliation': 'Department of Vascular Surgery, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Mowafy', 'Affiliation': 'Department of Vascular Surgery, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Elsaadany', 'Affiliation': 'Department of Vascular Surgery, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Soliman', 'Affiliation': 'Department of Vascular Surgery, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elmetwally', 'Affiliation': 'Department of Vascular Surgery, Mansoura University, Mansoura, Egypt.'}]",SAGE open medicine,['10.1177/2050312120927636']
2767,32551134,A randomized pilot study to evaluate graft versus fistula vascular access strategy in older patients with advanced kidney disease: results of a feasibility study.,"Background


Although older adults encompass almost half of patients with advanced chronic kidney disease, it remains unclear which long-term hemodialysis vascular access type, arteriovenous fistula or arteriovenous graft, is optimal with respect to effectiveness and patient satisfaction. Clinical outcomes based on the initial AV access type have not been evaluated in randomized controlled trials. This pilot study tested the feasibility of randomizing older adults with advanced kidney disease to initial arteriovenous fistula versus graft vascular access surgery.
Methods


Patients 65 years or older with pre-dialysis chronic kidney disease or incident end-stage kidney disease and no prior arteriovenous vascular access intervention were randomized in a 1:1 ratio to undergo surgical placement of a fistula or a graft after providing informed consent. Trial feasibility was evaluated as (i) recruitment of ≥ 70% of eligible participants, (ii) ≥ 50 to 70% of participants undergo placement of index arteriovenous access within 90 to 180 days of enrollment, respectively, (iii) ≥ 80% adherence to study-related assessments, and (iv) ≥ 70% of participants who underwent index arteriovenous access placement will have a follow-up duration of ≥ 12 months after index surgery date.
Results


Between September 2018 and October 2019, 81% (44/54) of eligible participants consented and were enrolled in the study; 11 had pre-dialysis chronic kidney disease, and 33 had incident or prevalent end-stage kidney disease. After randomization, 100% (21/21) assigned to arteriovenous fistula surgery and 78% (18/23) assigned to arteriovenous graft surgery underwent index arteriovenous access placement within a median (1st, 3rd quartile) of 5.0 (1.0, 14.0) days and 13.0 (5.0, 44.3) days, respectively, after referral to vascular surgery. The completion rates for study-specific assessments ranged between 40.0 and 88.6%. At median follow-up of 215.0 days, 5 participants expired, 7 completed 12 months of follow-up, and 29 are actively being followed. Assessments of grip strength, functional independence, and vascular access satisfaction were completed by > 85% of patients who reached pre-specified post-operative assessment time point.
Conclusions


Results from this study reveal it is feasible to enroll and randomize older adults with advanced kidney disease to one of two different arteriovenous vascular access placement surgeries. The study can progress with minor protocol adjustments to a multisite clinical trial.
Trial registration


Clinical Trials ID, NCT03545113.",2020,"Assessments of grip strength, functional independence, and vascular access satisfaction were completed by > 85% of patients who reached pre-specified post-operative assessment time point.
","['≥ 70% of eligible participants, (ii) ≥ 50 to 70% of participants undergo placement of index arteriovenous access within 90 to 180\u2009days of enrollment, respectively, (iii) ≥ 80% adherence to study-related assessments, and (iv', 'Patients 65\u2009years or older with pre-dialysis chronic kidney disease or incident end-stage kidney disease and no prior arteriovenous vascular access intervention', 'randomizing older adults with advanced kidney disease to initial arteriovenous fistula versus graft vascular access surgery', 'patients with advanced chronic kidney disease', 'older patients with advanced kidney disease', 'Results\n\n\nBetween September 2018 and October 2019, 81% (44/54) of eligible participants consented and were enrolled in the study; 11 had pre-dialysis chronic kidney disease, and 33 had incident or prevalent end-stage kidney disease', 'older adults with advanced kidney disease']","['graft versus fistula vascular access strategy', 'arteriovenous graft surgery underwent index arteriovenous access placement', 'surgical placement of a fistula or a graft after providing informed consent']","['grip strength, functional independence, and vascular access satisfaction']","[{'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0450109', 'cui_str': 'Arteriovenous'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1264634', 'cui_str': 'Pre-dialysis'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula'}, {'cui': 'C0740038', 'cui_str': 'Vascular graft'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0729665', 'cui_str': 'Arteriovenous graft'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0450109', 'cui_str': 'Arteriovenous'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]","[{'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",5.0,0.26567,"Assessments of grip strength, functional independence, and vascular access satisfaction were completed by > 85% of patients who reached pre-specified post-operative assessment time point.
","[{'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Murea', 'Affiliation': 'Department of Internal Medicine, Section on Nephrology, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157-1053 USA.'}, {'ForeName': 'Randolph L', 'Initials': 'RL', 'LastName': 'Geary', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Wake Forest School of Medicine, Winston-Salem, NC USA.'}, {'ForeName': 'Denise K', 'Initials': 'DK', 'LastName': 'Houston', 'Affiliation': 'Section on Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, NC USA.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Edwards', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Wake Forest School of Medicine, Winston-Salem, NC USA.'}, {'ForeName': 'Todd W', 'Initials': 'TW', 'LastName': 'Robinson', 'Affiliation': 'Department of Internal Medicine, Section on Nephrology, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157-1053 USA.'}, {'ForeName': 'Ross P', 'Initials': 'RP', 'LastName': 'Davis', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Wake Forest School of Medicine, Winston-Salem, NC USA.'}, {'ForeName': 'Justin B', 'Initials': 'JB', 'LastName': 'Hurie', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Wake Forest School of Medicine, Winston-Salem, NC USA.'}, {'ForeName': 'Timothy K', 'Initials': 'TK', 'LastName': 'Williams', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Wake Forest School of Medicine, Winston-Salem, NC USA.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Velazquez-Ramirez', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Wake Forest School of Medicine, Winston-Salem, NC USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Bagwell', 'Affiliation': 'Department of Internal Medicine, Section on Nephrology, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157-1053 USA.'}, {'ForeName': 'Audrey B', 'Initials': 'AB', 'LastName': 'Tuttle', 'Affiliation': 'Department of Internal Medicine, Section on Nephrology, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157-1053 USA.'}, {'ForeName': 'Shahriar', 'Initials': 'S', 'LastName': 'Moossavi', 'Affiliation': 'Department of Internal Medicine, Section on Nephrology, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157-1053 USA.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Rocco', 'Affiliation': 'Department of Internal Medicine, Section on Nephrology, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157-1053 USA.'}, {'ForeName': 'Barry I', 'Initials': 'BI', 'LastName': 'Freedman', 'Affiliation': 'Department of Internal Medicine, Section on Nephrology, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157-1053 USA.'}, {'ForeName': 'Jeff D', 'Initials': 'JD', 'LastName': 'Williamson', 'Affiliation': 'Section on Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, NC USA.'}, {'ForeName': 'Haiying', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC USA.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Divers', 'Affiliation': 'Division of Health Services Research, Department of Foundations of Medicine, NYU Long Island School of Medicine, Long Island, NY USA.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00619-9']
2768,32551271,Plasma Dissection Versus Tissue Dissection in Adenoid Surgery.,"Aim is to compare coblation versus conventional adenoidectomy, to evaluate whether this approach is adequate, safer and could be a coblation a good alternative of conventional adenoidectomy? It is a prospective randomized controlled study done at Civil Hospital Ahmedabad from January 2016 to January 2017 with 70 patients. The study includes children between age groups 5-11 years divided into Group A (38 children underwent coblation adenoidectomy) and Group B (32 children underwent conventional adenoidectomy) with an average follow-up period of 10 days, 1 month and 3 months. Information on average time of operation, intra-operative blood loss, post-operative pain, and time required regaining normal breathing pattern, presence of residual adenoid tissue 4 weeks after surgery and postoperative hemorrhage were gathered and compared. We found statistically significant differences in average operation time ( p  < 0.001), intra-operative blood loss ( p  < 0.001), post-operative pain ( p  < 0.0001) and time required regaining normal nasal breathing pattern ( p  < 0.001) presence of residual adenoid tissue 4 weeks after surgery ( p  < 0.0001) However, post operative hemorrhage ( p  > 0.5) was not significantly different between two groups. This study suggested a significantly less intra-operative or postoperative complications and morbidity in coblation adenoidectomy in comparison with conventional method. Coblation was associated with less pain and quick return to normal nasal breathing pattern. These findings indicate that coblation adenoidectomy is a safer, method and can be a better alternative of conventional method.",2020,"We found statistically significant differences in average operation time ( p  < 0.001), intra-operative blood loss ( p  < 0.001), post-operative pain ( p  < 0.0001) and time required regaining normal nasal breathing pattern ( p  < 0.001) presence of residual adenoid tissue 4 weeks after surgery ( p  < 0.0001)","['children between age groups 5-11\xa0years divided into Group A (38 children underwent', 'Civil Hospital Ahmedabad from January 2016 to January 2017 with 70 patients']","['coblation adenoidectomy', 'Plasma Dissection Versus Tissue Dissection in Adenoid Surgery', 'conventional adenoidectomy']","['time required regaining normal nasal breathing pattern', 'operative hemorrhage', 'pain and quick return to normal nasal breathing pattern', 'post-operative pain', 'average time of operation, intra-operative blood loss, post-operative pain, and time required regaining normal breathing pattern, presence of residual adenoid tissue 4\xa0weeks after surgery and postoperative hemorrhage', 'intra-operative blood loss', 'average operation time', 'intra-operative or postoperative complications and morbidity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001425', 'cui_str': 'Adenoid excision'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C0001428', 'cui_str': 'Adenoidal structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0079027', 'cui_str': 'Intraoperative hemorrhage'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0231795', 'cui_str': 'Normal respiratory function'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0001428', 'cui_str': 'Adenoidal structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",38.0,0.0414328,"We found statistically significant differences in average operation time ( p  < 0.001), intra-operative blood loss ( p  < 0.001), post-operative pain ( p  < 0.0001) and time required regaining normal nasal breathing pattern ( p  < 0.001) presence of residual adenoid tissue 4 weeks after surgery ( p  < 0.0001)","[{'ForeName': 'Vaidik Mayurkumar', 'Initials': 'VM', 'LastName': 'Chauhan', 'Affiliation': 'Department of ENT and Head and Neck Surgery, B.J Medical College, Civil Hospital, Ahmedabad, Gujarat India.'}, {'ForeName': 'Kalpesh B', 'Initials': 'KB', 'LastName': 'Patel', 'Affiliation': 'Department of ENT and Head and Neck Surgery, B.J Medical College, Civil Hospital, Ahmedabad, Gujarat India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Vishwakarma', 'Affiliation': 'Department of ENT and Head and Neck Surgery, B.J Medical College, Civil Hospital, Ahmedabad, Gujarat India.'}]",Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India,['10.1007/s12070-019-01721-y']
2769,32551273,A Comparative Study Between Septal Quilting Sutures Without Nasal Packing and Only Nasal Packing Post-septal Correction.,"Septal correction is the commonest surgery by rhinologists worldwide. We aimed at studying the comfort level of the patient with standard postoperative nasal packing with Merocel and placing quilting sutures in septum leaving the nose unpacked in the postoperative period. We conducted the study in the tertiary care centre enrolling 82 patients in a quasi-randomised method of odd and even numbers placing them in the nasal packing group and the quilting group respectively. We used analogue scoring method for subjective assessment of comfort level in the postoperative period and the surgeon objectively assessed the patient on follow up. The results were tabulated and analysed. Postoperative pain, headache and sleep disturbance was significantly more in the nasal packing group. We found that the crusting is commonly seen in patients in the nasal packing group. Quilting the nasal septum and leaving the nasal cavity unpacked increases the comfort level of the patient in the postoperative period. The resultant pain, headache and sleep disturbance caused by nasal packing can be significantly avoided by using quilting the septum without nasal packing. We also observed that by avoiding nasal packing postoperatively, the patients were more comfortable and compliant with the treatment regimen and follow-up.",2020,"Postoperative pain, headache and sleep disturbance was significantly more in the nasal packing group.",['tertiary care centre enrolling 82 patients in a quasi-randomised method of odd and even numbers placing them in the nasal packing group and the quilting group respectively'],"['Septal Quilting Sutures Without Nasal Packing and Only Nasal Packing Post-septal Correction', 'standard postoperative nasal packing with Merocel and placing quilting sutures']","['comfort level', 'resultant pain, headache and sleep disturbance', 'Postoperative pain, headache and sleep disturbance']","[{'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0442004', 'cui_str': 'Septal'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0127601', 'cui_str': 'Merocel'}, {'cui': 'C0442504', 'cui_str': 'Place'}]","[{'cui': 'C0517225', 'cui_str': 'Comfort level'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",82.0,0.0163577,"Postoperative pain, headache and sleep disturbance was significantly more in the nasal packing group.","[{'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Ramalingam', 'Affiliation': 'KMCH Institute of Health Sciences and Research, Coimbatore, Tamil Nadu India.'}, {'ForeName': 'Rajarajan', 'Initials': 'R', 'LastName': 'Venkatesan', 'Affiliation': 'TN MGR University, Chennai, Tamil Nadu India.'}, {'ForeName': 'Subramaniam', 'Initials': 'S', 'LastName': 'Somasundaram', 'Affiliation': 'KFMSR, Coimbatore, Tamil Nadu India.'}, {'ForeName': 'Kamindan', 'Initials': 'K', 'LastName': 'Kandasamy', 'Affiliation': 'TN MGR University, Chennai, Tamil Nadu India.'}, {'ForeName': 'Murugesan', 'Initials': 'M', 'LastName': 'Rajeswari', 'Affiliation': 'JIPMER, Pondicherry, India.'}]",Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India,['10.1007/s12070-019-01730-x']
2770,32551428,Abdominal palpation and percussion maneuvers do not affect bowel sounds.,"Objectives


Medical textbooks suggest that the frequency of bowel sounds may be altered by performing auscultation after palpation or percussion. We hypothesize that the frequency of bowel sounds is not affected by the order of abdominal examination.
Material and Methods


Both healthy volunteers (n= 80) and patients (n= 100) were enrolled in this crossover randomized study. Two different examination orders, one as inspection, palpation, percussion, auscultation (IPPA) and the other order as inspection, auscultation, palpation, percussion (IAPP) were used by two observers, one of which was blinded to the order of the physical examination and only performed auscultation. Bowel motilities of 40 participants were analyzed with duplex Doppler USG by a radiologist. The effects of changing the order of abdominal examination and palpation-percussion maneuvers on the frequency of bowel sounds were evaluated.
Results


Gender distribution was similar between the healthy patients and controls, and mean age of the entire study population was 47 (18-60) years. Differences between the mean bowel sound frequencies for abdominal examinations in order IPPA-IAPP versus IAPP-IPPA were evaluated for both healthy subjects and the patients. There were no differences between the first and second listening, nor were there differences between examinations performed in either order. Duplex Doppler Ultrasonographic (USG) assessments were performed on 20 healthy subjects and 20 patients before and after palpation and percussion; there were no statistically significant differences between the two listenings (p= 0.694).
Conclusion


According to both abdominal examinations and Doppler USG, the order of auscultation, whether performed before or after palpation or percussion, did not change the frequency of bowel sounds in this subject population.",2019,Differences between the mean bowel sound frequencies for abdominal examinations in order IPPA-IAPP versus IAPP-IPPA were evaluated for both healthy subjects and the patients.,"['20 healthy subjects and 20 patients before and after palpation and percussion', '40 participants', 'healthy volunteers (n= 80) and patients (n= 100', 'healthy patients and controls, and mean age of the entire study population was 47 (18-60) years']",['duplex Doppler USG'],"['inspection, palpation, percussion, auscultation (IPPA) and the other order as inspection, auscultation, palpation, percussion (IAPP', 'Duplex Doppler Ultrasonographic (USG) assessments']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C0030987', 'cui_str': 'Percussion'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0444916', 'cui_str': 'Duplex'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}]","[{'cui': 'C0199219', 'cui_str': 'Inspection'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C0030987', 'cui_str': 'Percussion'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0444916', 'cui_str': 'Duplex'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",20.0,0.0326114,Differences between the mean bowel sound frequencies for abdominal examinations in order IPPA-IAPP versus IAPP-IPPA were evaluated for both healthy subjects and the patients.,"[{'ForeName': 'Ayşe Sena', 'Initials': 'AS', 'LastName': 'Çalış', 'Affiliation': 'Medical Student, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Kaya', 'Affiliation': 'Medical Student, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Lijana', 'Initials': 'L', 'LastName': 'Mehmetaj', 'Affiliation': 'Medical Student, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Büşra', 'Initials': 'B', 'LastName': 'Yılmaz', 'Affiliation': 'Medical Student, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Elif Nurdan', 'Initials': 'EN', 'LastName': 'Demir', 'Affiliation': 'Medical Student, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Derya', 'Initials': 'D', 'LastName': 'Öztuna', 'Affiliation': 'Department of Biostatistics, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Evren', 'Initials': 'E', 'LastName': 'Üstüner', 'Affiliation': 'Department of Radiology, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Halil İbrahim', 'Initials': 'Hİ', 'LastName': 'Açar', 'Affiliation': 'Department of Anatomy, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Serhat', 'Initials': 'S', 'LastName': 'Tokgöz', 'Affiliation': 'Department of General Surgery, University of Health Sciences, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Muzaffer', 'Initials': 'M', 'LastName': 'Akkoca', 'Affiliation': 'Department of General Surgery, University of Health Sciences, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Mehmet Ayhan', 'Initials': 'MA', 'LastName': 'Kuzu', 'Affiliation': 'Department of General Surgery, Ankara University School of Medicine, Ankara, Turkey.'}]",Turkish journal of surgery,['10.5578/turkjsurg.4291']
2771,32551445,Perioperative Effects of Induction with High-dose Rocuronium during Laparoscopic Cholecystectomy.,"Objective


We aimed to investigate the effects of high-dose rocuronium administration on intra-abdominal pressure (IAP) and surgical conditions during anaesthesia induction and laparoscopic cholecystectomy anaesthesia induction, respectively. Further, we aimed to determine postoperative nausea and vomiting (PONV) and pain scores following the laparoscopic cholecystectomy.
Methods


Patients with American Society of Anesthesiologists (ASA) score of I-III, aged 18 to 75 years and who were scheduled for surgery under general anaesthesia were included in the study. Patients were randomised and a high-dose of 1.2 mg kg -1  rocuronium was given to Group A and 0.6 mg kg -1  rocuronium to Group B. The intraoperative train of four (TOF) ratio and post-tetanic count (PTC) were measured. Surgery was initiated with a low IAP of 7 mmHg. The surgeon evaluated surgical conditions with a 4-step surgical field scale and increased the IAP when necessary. PONV at 4, 12 and 24 hours and postoperative pain at 2 and 24 hours and 3 days were evaluated.
Results


There were no significant differences in the demographic and haemodynamic parameters between the groups. In high-dose rocuronium Group A, IAP values were significantly lower in the first 20 minutes compared to Group B. The duration of operations was significantly shorter in Group A (29.00±7.39 minute vs. 34.63±12.00 minute, p=0.044). PONV in the first 12 hours was significantly lower in Group A (p<0.05).
Conclusion


High-dose rocuronium-induced deep neuromuscular block helped perform laparoscopic cholecystectomy operations with lower values of IAP compared to a normal dose rocuronium. It also shortened duration of operation and reduced PONV and pain.",2020,"PONV in the first 12 hours was significantly lower in Group A (p<0.05).
","['Laparoscopic Cholecystectomy', 'Patients with American Society of Anesthesiologists (ASA) score of I-III, aged 18 to 75 years and who were scheduled for surgery under general anaesthesia were included in the study']","['rocuronium to Group B', 'rocuronium', 'laparoscopic cholecystectomy', 'High-dose Rocuronium']","['demographic and haemodynamic parameters', 'intra-abdominal pressure (IAP) and surgical conditions', 'postoperative pain', 'intraoperative train of four (TOF) ratio and post-tetanic count (PTC', 'IAP values', 'shortened duration of operation and reduced PONV and pain', 'PONV', 'duration of operations', 'postoperative nausea and vomiting (PONV) and pain scores']","[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1512911', 'cui_str': 'Intraabdominal route'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0428698', 'cui_str': 'Train of four ratio'}, {'cui': 'C0428701', 'cui_str': 'Post-tetanic count'}, {'cui': 'C0015491', 'cui_str': 'factor IX'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.1036,"PONV in the first 12 hours was significantly lower in Group A (p<0.05).
","[{'ForeName': 'Selim', 'Initials': 'S', 'LastName': 'Turhanoğlu', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Hatay Mustafa Kemal University School of Medicine, Hatay, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Tunç', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Hatay Mustafa Kemal University School of Medicine, Hatay, Turkey.'}, {'ForeName': 'Menekşe', 'Initials': 'M', 'LastName': 'Okşar', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Hatay Mustafa Kemal University School of Medicine, Hatay, Turkey.'}, {'ForeName': 'Muhyittin', 'Initials': 'M', 'LastName': 'Temiz', 'Affiliation': 'Department of General Surgery, Hatay Mustafa Kemal University School of Medicine, Hatay, Turkey.'}]",Turkish journal of anaesthesiology and reanimation,['10.5152/TJAR.2019.31855']
2772,32551446,Palonosetron Pretreatment is not as Effective as Lignocaine for Attenuation of Pain on Injection of Propofol.,"Objective


5-HT3 receptor antagonists are known to possess local anesthetic properties and are commonly used for the alleviation of pain following propofol injection. Palonosetron, a newer molecule, has shown contradictory results for this property. The aim of this study was to compare the effect of palonosetron pretreatment in alleviating propofol injection pain with that of lignocaine. Their comparative effect on various hemodynamic parameters was also evaluated.
Methods


A total of 100 adult patients were randomly assigned to one of two groups: group L received lignocaine 40 mg in 5 mL of 0.9% saline pretreatment solution and group P received 0.075 mg palonosetron in 5 mL 0.9% of saline pretreatment solution. After 2 minutes, the tourniquet was released and one-fourth of the total calculated dose of propofol was administered, after which the pain assessment was made. The Students t-test was used for comparing the difference of mean between the two groups after testing for equality of variance using F-statistics. Categorical variables were expressed as a percentage, and the Chi-square test was performed to assess the independence of attributes. Repeated-measure analysis of variance was used to compare the change in heart rate and mean arterial pressure over three time points between the two groups.
Results


The proportion of pain reported by the subjects in the lignocaine group was significantly lower as compared to the subjects in the palonosetron group (p=0.001). No significant difference of mean heart rate and mean arterial pressure was observed between the two groups following these interventions.
Conclusion


The efficacy of palonosetron in alleviating the pain on injection of propofol was significantly less than that of lignocaine.",2020,The efficacy of palonosetron in alleviating the pain on injection of propofol was significantly less than that of lignocaine.,['100 adult patients'],"['Lignocaine', 'lignocaine 40 mg in 5 mL of 0.9% saline pretreatment solution and group P received 0.075 mg palonosetron in 5 mL 0.9% of saline pretreatment solution', 'Palonosetron', 'lignocaine', 'propofol', 'palonosetron']","['heart rate and mean arterial pressure', 'pain on injection of propofol', 'mean heart rate and mean arterial pressure', 'proportion of pain']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0441849', 'cui_str': 'Group P'}, {'cui': 'C4517416', 'cui_str': '0.075'}, {'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",100.0,0.0305606,The efficacy of palonosetron in alleviating the pain on injection of propofol was significantly less than that of lignocaine.,"[{'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Kant', 'Affiliation': 'Indira Gandhi Institute of Medical Sciences, Patna, India.'}, {'ForeName': 'Prakash K', 'Initials': 'PK', 'LastName': 'Dubey', 'Affiliation': 'Indira Gandhi Institute of Medical Sciences, Patna, India.'}, {'ForeName': 'Alok', 'Initials': 'A', 'LastName': 'Ranjan', 'Affiliation': 'All India Institute of Medical Sciences, Patna, India.'}]",Turkish journal of anaesthesiology and reanimation,['10.5152/TJAR.2019.79477']
2773,32551447,The Effect of the Open and Closed System Suctions on Pain Severity and Physiological Indicators in Mechanically Ventilated Patients with Traumatic Brain Injury: A Randomised Controlled Trial.,"Objective


Tracheal suctioning can cause pain and physiological indicator variations in patients with traumatic brain injury (TBI). The aim of the present study was to compare pain severity and physiological indicator variations during the closed tracheal suction system (CTSS) and open tracheal suction system (OTSS) in patients with TBI.
Methods


This study was a clinical trial. Samples included all ventilated patients with TBI. The patients were randomly divided into the OTSS and CTSS groups. In both groups, the Critical Care Pain Observation Tool (CPOT) and physiological indicators were recorded by three nurses prior to suctioning, the end of suctioning and 5 min after suction completion. Data were analysed using the independent t-test and repeated measurement tests.
Results


A total of 112 patients participated in the present study. Before the interventions, the mean value of the Glasgow Coma Scale was 6.45±1.13, blood pressure 128.33±20.54, saturated oxygen in arterial blood (SpO 2 ) 96.74±2.76, respiratory rate (RR) 15.06±3.98, end-tidal CO2 (EtCO 2 ) 36.2±21.98, heart rate 82.18±42.33 and CPOT-based pain 0.43±0.94 in the patients. Independent t-test was used to compare CTSS and OTSS, suggesting significant differences with respect to the mean values of SpO 2 , RR and EtCO 2  immediately after suctioning. This test showed significant differences between the two groups with respect to pain intensity at all three points of measurement. The two groups were also found to be significantly different with respect to RR measured 5 min after suctioning (p<0.05).
Conclusion


Compared to OTSS, CTSS can cause higher reductions in pain levels during and after suctioning in patients with head traumas and can also cause higher improvements in physiological indicators, such as RR, O 2  saturation and EtCO 2 .",2020,"Compared to OTSS, CTSS can cause higher reductions in pain levels during and after suctioning in patients with head traumas and can also cause higher improvements in physiological indicators, such as RR, O 2  saturation and EtCO 2 .","['112 patients participated in the present study', 'Mechanically Ventilated Patients with Traumatic Brain Injury', 'patients with traumatic brain injury (TBI', 'patients with TBI', 'Samples included all ventilated patients with TBI']","['Tracheal suctioning', 'OTSS and CTSS', 'closed tracheal suction system (CTSS) and open tracheal suction system (OTSS', 'Open and Closed System Suctions', 'OTSS, CTSS']","['respiratory rate (RR) 15.06±3.98', 'heart rate 82.18±42.33 and CPOT-based pain', 'mean value of the Glasgow Coma Scale', 'pain severity and physiological indicator variations', 'pain intensity', 'pain levels', 'Pain Severity and Physiological Indicators', 'Critical Care Pain Observation Tool (CPOT) and physiological indicators', 'blood pressure 128.33±20.54, saturated oxygen in arterial blood (SpO 2 ']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C2945595', 'cui_str': 'Tracheal'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C3879204', 'cui_str': 'Tracheal suction system'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0229665', 'cui_str': 'Arterial blood'}]",112.0,0.0491781,"Compared to OTSS, CTSS can cause higher reductions in pain levels during and after suctioning in patients with head traumas and can also cause higher improvements in physiological indicators, such as RR, O 2  saturation and EtCO 2 .","[{'ForeName': 'Abbasali', 'Initials': 'A', 'LastName': 'Ebrahimian', 'Affiliation': 'Nursing Care Research Center, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Maedeh', 'Initials': 'M', 'LastName': 'Tourdeh', 'Affiliation': 'School of Paramedicine, Qom University of Medical Sciences, Qom, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Paknazar', 'Affiliation': 'Social Determinants of Health Research Center, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Davari', 'Affiliation': 'Student Research Committee, Semnan University of Medical Sciences, Semnan, Iran.'}]",Turkish journal of anaesthesiology and reanimation,['10.5152/TJAR.2019.03342']
2774,32558913,Effectiveness of a Mouth Care Program Provided by Nursing Home Staff vs Standard Care on Reducing Pneumonia Incidence: A Cluster Randomized Trial.,"Importance


Pneumonia affects more than 250 000 nursing home (NH) residents annually. A strategy to reduce pneumonia is to provide daily mouth care, especially to residents with dementia.
Objective


To evaluate the effectiveness of Mouth Care Without a Battle, a program that increases staff knowledge and attitudes regarding oral hygiene, changes mouth care, and improves oral hygiene, in reducing the incidence of pneumonia among NH residents.
Design, Setting, and Participants


This pragmatic cluster randomized trial observing 2152 NH residents for up to 2 years was conducted from September 2014 to May 2017. Data collectors were masked to study group. The study included 14 NHs from regions of North Carolina that evidenced proportionately high rehospitalization rates for pneumonia and long-term care residents. Nursing homes were pair matched and randomly assigned to intervention or control groups.
Intervention


Mouth Care Without a Battle is a standardized program that teaches that mouth care is health care, provides instruction on individualized techniques and products for mouth care, and trains caregivers to provide care to residents who are resistant and in special situations. The control condition was standard mouth care.
Main Outcomes and Measures


Pneumonia incidence (primary) and hospitalization and mortality (secondary), obtained from medical records.
Results


Overall, the study enrolled 2152 residents (mean [SD] age, 79.4 [12.4] years; 1281 [66.2%] women; 1180 [62.2%] white residents). Participants included 1219 residents (56.6%) in 7 intervention NHs and 933 residents (43.4%) in 7 control NHs. During the 2-year study period, the incidence rate of pneumonia per 1000 resident-days was 0.67 and 0.72 in the intervention and control NHs, respectively. Neither the primary (unadjusted) nor secondary (covariate-adjusted) analyses found a significant reduction in pneumonia due to Mouth Care Without a Battle during 2 years (unadjusted incidence rate ratio, 0.90; upper bound of 1-sided 95% CI, 1.24; P = .27; adjusted incidence rate ratio, 0.92; upper bound of 1-sided 95% CI, 1.27; P = .30). In the second year, the rate of pneumonia was nonsignificantly higher in intervention NHs. Adjusted post hoc analyses limited to the first year found a significant reduction in pneumonia incidence in intervention NHs (IRR, 0.69; upper bound of 1-sided 95% CI, 0.94; P = .03).
Conclusions and Relevance


This matched-pairs cluster randomized trial of a mouth care program compared with standard care was not effective in reducing pneumonia incidence at 2 years, although reduction was found during the first year. The lack of significant results in the second year may be associated with sustainability. Improving mouth care in US NHs may require the presence and support of dedicated oral care aides.
Trial Registration


ClinicalTrials.gov Identifier: NCT03817450.",2020,"This matched-pairs cluster randomized trial of a mouth care program compared with standard care was not effective in reducing pneumonia incidence at 2 years, although reduction was found during the first year.","['14 NHs from regions of North Carolina that evidenced proportionately high rehospitalization rates for pneumonia and long-term care residents', 'residents with dementia', '2152 NH residents for up to 2 years was conducted from September 2014 to May 2017', 'Nursing homes', '250\u202f000 nursing home (NH) residents annually', 'Participants included 1219 residents (56.6%) in 7 intervention NHs and 933 residents (43.4%) in 7 control NHs', 'study enrolled 2152 residents (mean [SD] age, 79.4 [12.4] years; 1281 [66.2%] women; 1180 [62.2%] white residents']","['mouth care program', 'Intervention\n\n\nMouth Care', 'Mouth Care Program Provided by Nursing Home Staff vs Standard Care']","['Pneumonia Incidence', 'pneumonia due to Mouth Care', 'Measures\n\n\nPneumonia incidence (primary) and hospitalization and mortality (secondary), obtained from medical records', 'incidence rate of pneumonia', 'pneumonia incidence', 'rate of pneumonia']","[{'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C5191368', 'cui_str': '933'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517543', 'cui_str': '12.4'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C1272386', 'cui_str': 'Mouth care management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1272386', 'cui_str': 'Mouth care management'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0025102', 'cui_str': 'Medical record'}]",2152.0,0.082596,"This matched-pairs cluster randomized trial of a mouth care program compared with standard care was not effective in reducing pneumonia incidence at 2 years, although reduction was found during the first year.","[{'ForeName': 'Sheryl', 'Initials': 'S', 'LastName': 'Zimmerman', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Sloane', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Ward', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Wretman', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Sally C', 'Initials': 'SC', 'LastName': 'Stearns', 'Affiliation': 'Gillings School of Global Public Health, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Poole', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Preisser', 'Affiliation': 'Gillings School of Global Public Health, University of North Carolina at Chapel Hill.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.4321']
2775,32558951,Anterior Cruciate Ligament Reconstruction Reinitiates an Inflammatory and Chondrodegenerative Process in the Knee Joint.,"Anterior cruciate ligament(ACL) injury leads to a sustained increase in synovial fluid concentrations of inflammatory cytokines and biomarkers of cartilage breakdown. While this has been documented post-injury, it remains unclear whether ACL reconstruction surgery contributes to the inflammatory process and/or cartilage breakdown.This study is a secondary analysis of 14 patients (9 males/5 females, mean age=19, mean BMI=28) enrolled in an IRB-approved randomized clinical trial. Arthrocentesis was performed at initial presentation (mean=6 days post-injury), immediately prior to surgery (mean=23 days post-injury), one-week post-surgery, and one-month post-surgery. ELISA kits were used to determine concentrations of CTXII, IL-6 and IL-1β in the synovial fluid. The log transformed IL-1β was not normally distributed; therefore, changes between time points were evaluatedusing a non-parametric Kruskal-Wallis one-way ANOVA. IL-1β concentrations significantly increased from the day of surgery to the first postoperative time point (p<.001) and significantly decreased at the 4-week postoperative visit (p=.03). IL-1β concentrations at the 4-week postoperative visit remained significantly greater than both preoperative time points (p >.05).IL-6 concentrations at 1 week post-surgery were significantly higher than at initial presentation (p=0.013), the day of surgery (p<0.001), and 4 weeks after surgery (p=0.002). CTX-II concentrations did not differ between the first three time points (p>.99) but significantly increased at 4 weeks post-surgery (p<.01). ACL reconstruction appears to reinitiate an inflammatory response followed byan increase in markers for cartilage degradation. ACL reconstruction appears to initiate a second ""inflammatory hit"" resulting in increased chondral breakdown suggesting that post-operative chondroprotection may be needed. This article is protected by copyright. All rights reserved.",2020,CTX-II concentrations did not differ between the first three time points (p>.99) but significantly increased at 4 weeks post-surgery (p<.01).,"['14 patients (9 males/5 females, mean age=19, mean BMI=28) enrolled in an IRB-approved randomized clinical trial']","['Anterior Cruciate Ligament Reconstruction Reinitiates', 'ACL reconstruction']","['concentrations of CTXII, IL-6 and IL-1β', 'IL-1β concentrations', 'CTX-II concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}]","[{'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}]",,0.0209689,CTX-II concentrations did not differ between the first three time points (p>.99) but significantly increased at 4 weeks post-surgery (p<.01).,"[{'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Hunt', 'Affiliation': 'Department of Orthopedic Surgery, University of Kentucky, Lexington, KY.'}, {'ForeName': 'Caitlin E-W', 'Initials': 'CE', 'LastName': 'Conley', 'Affiliation': 'Department of Orthopedic Surgery, University of Kentucky, Lexington, KY.'}, {'ForeName': 'Cale A', 'Initials': 'CA', 'LastName': 'Jacobs', 'Affiliation': 'Department of Orthopedic Surgery, University of Kentucky, Lexington, KY.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Ireland', 'Affiliation': 'Department of Orthopedic Surgery, University of Kentucky, Lexington, KY.'}, {'ForeName': 'Darren L', 'Initials': 'DL', 'LastName': 'Johnson', 'Affiliation': 'Department of Orthopedic Surgery, University of Kentucky, Lexington, KY.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lattermann', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}]",Journal of orthopaedic research : official publication of the Orthopaedic Research Society,['10.1002/jor.24783']
2776,32558989,"Effects of danicamtiv, a novel cardiac myosin activator, in heart failure with reduced ejection fraction: experimental data and clinical results from a phase 2a trial.","BACKGROUND


Both left ventricular (LV) and left atrial (LA) dysfunction and remodelling contribute to adverse outcomes in heart failure with reduced ejection fraction (HFrEF). Danicamtiv is a novel, cardiac myosin activator that enhances cardiomyocyte contraction.
METHODS


We studied the effects of danicamtiv on LV and LA function in non-clinical studies (ex vivo: skinned muscle fibres and myofibrils; in vivo: dogs with heart failure) and in a randomized, double-blind, single- and multiple-dose phase 2a trial in patients with stable HFrEF (placebo, n=10; danicamtiv, n=30; 50-100 mg twice daily for 7 days).
RESULTS


Danicamtiv increased ATPase activity and calcium sensitivity in LV and LA myofibrils/muscle fibres. In dogs with heart failure, danicamtiv improved LV stroke volume (+10.6 mL; p<0.05) and LA emptying fraction (+10.7%, p<0.05). In patients with HFrEF (mean age 60 years, 25% women, ischaemic heart disease 48%, mean LV ejection fraction 32%), treatment-emergent adverse events, mostly mild, were reported in 17 patients (57%) receiving danicamtiv and 4 patients (40%) receiving placebo. Danicamtiv (at plasma concentrations ≥2000 ng/mL) increased stroke volume (up to +7.8 mL, p<0.01), improved global longitudinal (up to -1.0%, p<0.05) and circumferential strain (up to -3.3%, p<0.01), decreased LA minimal volume index (up to -2.4 mL/m 2  , p<0.01) and increased LA function index (up to 6.1, p<0.01), when compared with placebo.
CONCLUSIONS


Danicamtiv was well tolerated and improved LV systolic function in patients with HFrEF. A marked improvement in LA volume and function was also observed in patients, consistent with pre-clinical findings of direct activation of LA contractility.",2020,"In dogs with heart failure, danicamtiv improved LV stroke volume (+10.6 mL; p<0.05) and LA emptying fraction (+10.7%, p<0.05).","['heart failure with reduced ejection fraction', 'heart failure with reduced ejection fraction (HFrEF', 'vivo: dogs with heart failure', 'patients with stable', 'patients with HFrEF']","['danicamtiv, a novel cardiac myosin activator', 'HFrEF (placebo', 'placebo']","['circumferential strain', 'LA function index', 'LA volume and function', 'stroke volume', 'tolerated and improved LV systolic function', 'LV and LA function', 'LA minimal volume index', 'LA emptying fraction', 'LV stroke volume', 'global longitudinal', 'ATPase activity and calcium sensitivity']","[{'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0012984', 'cui_str': 'Canis lupus familiaris'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0949656', 'cui_str': 'Cardiac Myosin'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0078995', 'cui_str': 'Left Atrial Function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0001473', 'cui_str': 'Adenosinetriphosphatase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.144767,"In dogs with heart failure, danicamtiv improved LV stroke volume (+10.6 mL; p<0.05) and LA emptying fraction (+10.7%, p<0.05).","[{'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Tamby', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Cleland', 'Affiliation': 'Robertson Centre for Biostatistics and Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Koren', 'Affiliation': 'Jacksonville Center for Clinical Research, Jacksonville, FL, USA.'}, {'ForeName': 'Leslie B', 'Initials': 'LB', 'LastName': 'Forgosh', 'Affiliation': 'HealthEast Heart Care, Saint Paul, MN, USA.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Gupta', 'Affiliation': 'Tennova Healthcare-Harton, Tullahoma, TN, USA.'}, {'ForeName': 'Lars H', 'Initials': 'LH', 'LastName': 'Lund', 'Affiliation': 'Karolinska Institutet, Department of Medicine, 17177 Stockholm, Sweden, and Karolinska University Hospital, Heart and Vascular Theme, 17176, Stockholm, Sweden.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Camacho', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Karra', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Henk P', 'Initials': 'HP', 'LastName': 'Swart', 'Affiliation': 'Antonius Ziekenhuis Sneek, Sneek, Netherlands.'}, {'ForeName': 'Pierpaolo', 'Initials': 'P', 'LastName': 'Pellicori', 'Affiliation': 'Robertson Centre for Biostatistics and Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Wagner', 'Affiliation': 'Charité Research Organization, Berlin, Germany.'}, {'ForeName': 'Ray E', 'Initials': 'RE', 'LastName': 'Hershberger', 'Affiliation': 'Divisions of Human Genetics and Cardiovascular Medicine, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Narayana', 'Initials': 'N', 'LastName': 'Prasad', 'Affiliation': ""Cardiovascular Imaging Core Laboratory, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Anderson', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Anto', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Kaylyn', 'Initials': 'K', 'LastName': 'Bell', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Jay M', 'Initials': 'JM', 'LastName': 'Edelberg', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Fang', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Henze', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Kelly', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Kurio', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Wanying', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Wells', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Sam L', 'Initials': 'SL', 'LastName': 'Teichman', 'Affiliation': 'Teichman Drug Development Consulting, Oakland, CA, USA.'}, {'ForeName': 'Carlos L', 'Initials': 'CL', 'LastName': 'Del Rio', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}]",European journal of heart failure,['10.1002/ejhf.1933']
2777,32559003,Evaluation and Comparison of Histologic Changes and Implant Survival in Extraction Sites Immediately Grafted with Two Different Xenografts: A Randomized Clinical Pilot Study.,"OBJECTIVES


The purpose of this prospective, single-center randomized pilot study was to histologically evaluate and compare vital bone development in premolar and molar extraction sites grafted with 2 different bovine-derived xenografts. The secondary outcome of interest was implant survival in the grafted sites.
MATERIALS AND METHODS


Adult patients in need of at least 2 tooth extractions were enrolled. A paired design was used; each patient received at least one of each type of graft at different sites. Each extraction site was randomized to one of 2 xenograft treatment groups. A resorbable membrane was always placed and primary intention soft tissue closure was achieved. Four months later, implants were placed and a trephine drill was used to remove bone cores for histologic and histomorphometric analysis.
RESULTS


Sixteen patients with 40 extraction sites were enrolled; 20 sites were grafted with one type of xenograft and 20 with another. Mean patient age was 53.5 years, and 65% of patients were male. Evaluation of bone core samples taken from grafted sites showed no significant difference in the mean value of percentage of new bone formation between the different grafted sites (33.4 % and 32.4 %, p=0.76). Cumulative implant survival was 97.5% at the 24-months follow-up visit.
CONCLUSION


Within the limitations of this pilot study, no statistically significant differences in new bone growth between sites grafted with 2 different types of xenograft were found. Both graft materials promoted the formation of new bone and provided osseous support for implant placement after socket grafting.",2020,"Evaluation of bone core samples taken from grafted sites showed no significant difference in the mean value of percentage of new bone formation between the different grafted sites (33.4 % and 32.4 %, p=0.76).","['Mean patient age was 53.5 years, and 65% of patients were male', 'Sixteen patients with 40 extraction sites were enrolled; 20 sites were grafted with one type of xenograft and 20 with another', 'Adult patients in need of at least 2 tooth extractions were enrolled', 'premolar and molar extraction sites grafted with 2 different bovine-derived xenografts']",[],"['new bone growth', 'Histologic Changes and Implant Survival', 'implant survival', 'Cumulative implant survival', 'mean value of percentage of new bone formation']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0520484', 'cui_str': 'Xenogeneic transplantation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}]",[],"[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0971859', 'cui_str': 'Bone Growth'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0334168', 'cui_str': 'New bone formation'}]",16.0,0.0481422,"Evaluation of bone core samples taken from grafted sites showed no significant difference in the mean value of percentage of new bone formation between the different grafted sites (33.4 % and 32.4 %, p=0.76).","[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Sivolella', 'Affiliation': 'University of Padova, Department of Neurosciences, Dentistry Section, Via Giustiniani, 1, 35131, Padova, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Botticelli', 'Affiliation': 'ARDEC Academy, Ariminum Odontologica SRL, Viale Pascoli 67, 47923, Rimini, Italy.'}, {'ForeName': 'Sanjana', 'Initials': 'S', 'LastName': 'Prasad', 'Affiliation': 'Hard Tissue Research Laboratory, Biological and Diagnostic Sciences, School of Dentistry, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ricci', 'Affiliation': 'University of Padova, Department of Neurosciences, Dentistry Section, Via Giustiniani, 1, 35131, Padova, Italy.'}, {'ForeName': 'Eriberto', 'Initials': 'E', 'LastName': 'Bressan', 'Affiliation': 'University of Padova, Department of Neurosciences, Dentistry Section, Via Giustiniani, 1, 35131, Padova, Italy.'}, {'ForeName': 'Hari', 'Initials': 'H', 'LastName': 'Prasad', 'Affiliation': 'Hard Tissue Research Laboratory, Biological and Diagnostic Sciences, School of Dentistry, University of Minnesota, Minneapolis, MN, USA.'}]",Clinical oral implants research,['10.1111/clr.13626']
2778,32559025,Strengthening effect of bioceramic cement when used to repair simulated internal resorption cavities in endodontically treated teeth.,"BACKGROUND


The reinforcement of teeth with internal root resorption is essential to prevent their fracture.
OBJECTIVES


The aim of this study was to assess the fracture resistance of the premolar teeth with internal root resorption cavities (IRCs), repaired with glass-ionomer cement (GIC), gutta-percha (GP) or EndoSequence® Root Repair MaterialTM (RRM).
MATERIAL AND METHODS


Forty lower premolars, instrumented to size 50, were used. Ten teeth were assigned to the control group, which received the full obturation of the root canals. In the remaining 30, IRCs were prepared with Gates-Glidden burs. The apical 8 mm was obturated to the level of IRC using the single-cone technique. Then, the teeth were divided into 3 groups according to the material used for repairing the cavities (n = 10): GIC; GP; and RRM. The canals were filled with respective materials and backfilled with GP. All of the specimens were scanned at the level of IRC with a micro-computed tomography (micro-CT) system, and the volume of the IRCs and the percentages of voids in the filling materials were measured. The specimens were subjected to fracture testing. The force recorded at the time of fracture was analyzed with the Kruskal-Wallis test and the independent t-test.
RESULTS


The control group showed a significantly higher mean value of fracture resistance as compared to the groups with IRCs (p < 0.05). No significant difference was found between GIC and RRM, whereas the GP group had a significantly lower fracture resistance than other tested IRC groups (p < 0.05). The percentage of voids was significantly higher in the GIC group as compared to the GP and RRM groups (p < 0.05).
CONCLUSIONS


EndoSequence Root Repair Material provides more strength to the teeth than the GP/sealer technique when both are used to fill a resorption cavity. The fracture resistance of the teeth filled with RRM was close to that obtained with GIC.",2020,"No significant difference was found between GIC and RRM, whereas the GP group had a significantly lower fracture resistance than other tested IRC groups (p < 0.05).","['Forty lower premolars, instrumented to size 50, were used', 'endodontically treated teeth']","['bioceramic cement', 'internal root resorption cavities (IRCs), repaired with glass-ionomer cement (GIC), gutta-percha (GP) or EndoSequence® Root Repair MaterialTM (RRM']","['percentage of voids', 'fracture resistance', 'mean value of fracture resistance', 'GIC and RRM']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0376699', 'cui_str': 'Tooth, Endodontically-Treated'}]","[{'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0035851', 'cui_str': 'Root Resorption'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0017597', 'cui_str': 'Glass-ionomer dental material'}, {'cui': 'C0018407', 'cui_str': 'Gutta percha'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0017597', 'cui_str': 'Glass-ionomer dental material'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",10.0,0.0179111,"No significant difference was found between GIC and RRM, whereas the GP group had a significantly lower fracture resistance than other tested IRC groups (p < 0.05).","[{'ForeName': 'Wafaa Abdelbaky', 'Initials': 'WA', 'LastName': 'Khalil', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Faisal', 'Initials': 'F', 'LastName': 'Alghamdi', 'Affiliation': 'Department of Oral Biology, Faculty of Dentistry, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Esraa', 'Initials': 'E', 'LastName': 'Aljahdali', 'Affiliation': 'Faculty of Dentistry, King Abdulaziz University, Jeddah, Saudi Arabia.'}]",Dental and medical problems,['10.17219/dmp/116743']
2779,32551958,Application of Enhanced Recovery After Surgery in Perioperative Period of Tympanoplasty and Mastoidectomy.,"INTRODUCTION


Enhanced recovery after surgery (ERAS) protocols are a series of perioperative care to optimize preoperative preparation, prevent postoperative complications, minimize stress, and speedup recovery. Tympanoplasty and mastoidectomy are common surgical procedures for chronic suppurative otitis media.
OBJECTIVE


To compare the efficacy and safety between ERAS and conventional recovery after surgery in the perioperative period of chronic suppurative otitis media.
METHODS


From April 2018 to February 2019, a total of 84 patients scheduled for tympanoplasty and/or mastoidectomy due to chronic suppurative otitis media were involved and randomly divided into the ERAS group and the control group. The patients' preoperative anxiety, postoperative pain, and comfort level were determined by comparing the results of Self-Rating Anxiety Scale (SAS), Visual Analog Scale (VAS) and General Comfort Questionnaire (GCQ). The postoperative complications, postoperative hospital stay, and hospitalization cost were calculated.
RESULTS


The ERAS group showed a lower SAS score (30 [28-31.5] vs 35 [30-43],  P  < .05], a higher GCQ score (88 [84-100] vs 83 [78.25-92.25],  P  < .05), and a lower VAS score (0 [0-0] vs 1 [0-2],  P  < .05] after surgery. No significant difference ( P  > .05) was observed between the ERAS group and the control group in postoperative complications, postoperative hospitalization time, and hospitalization cost, respectively.
CONCLUSION


Enhanced recovery after surgery can reduce pain and improve comfort in the perioperative period of chronic suppurative otitis media.",2020,"No significant difference ( P  > .05) was observed between the ERAS group and the control group in postoperative complications, postoperative hospitalization time, and hospitalization cost, respectively.
","['chronic suppurative otitis media', 'From April 2018 to February 2019, a total of 84 patients scheduled for tympanoplasty and/or mastoidectomy due to chronic suppurative otitis media']","['ERAS', 'Tympanoplasty and Mastoidectomy', 'Tympanoplasty and mastoidectomy']","['lower SAS score', 'preoperative anxiety, postoperative pain, and comfort level', 'pain and improve comfort', 'Self-Rating Anxiety Scale (SAS), Visual Analog Scale (VAS) and General Comfort Questionnaire (GCQ', 'postoperative complications, postoperative hospitalization time, and hospitalization cost, respectively', 'efficacy and safety', 'higher GCQ score', 'postoperative complications, postoperative hospital stay, and hospitalization cost', 'lower VAS score']","[{'cui': 'C0271454', 'cui_str': 'Chronic purulent otitis media'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}, {'cui': 'C0198154', 'cui_str': 'Mastoidectomy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}, {'cui': 'C0198154', 'cui_str': 'Mastoidectomy'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0517225', 'cui_str': 'Comfort level'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",84.0,0.0161693,"No significant difference ( P  > .05) was observed between the ERAS group and the control group in postoperative complications, postoperative hospitalization time, and hospitalization cost, respectively.
","[{'ForeName': 'Jing-Qian', 'Initials': 'JQ', 'LastName': 'Tan', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yu-Bin', 'Initials': 'YB', 'LastName': 'Chen', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Wei-Hao', 'Initials': 'WH', 'LastName': 'Wang', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Shao-Li', 'Initials': 'SL', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Qi-Lin', 'Initials': 'QL', 'LastName': 'Zhou', 'Affiliation': 'Nursing Department, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.'}]","Ear, nose, & throat journal",['10.1177/0145561320928222']
2780,32552264,Extended-Release Oral Milrinone for the Treatment of Heart Failure With Preserved Ejection Fraction.,"Background Heart failure with preserved ejection fraction (HFpEF) is an increasingly prevalent form of heart failure, representing half of the total burden of heart failure. We hypothesised that modulation of the phosphodiesterase type 3/cyclic AMP using a novel oral formulation of milrinone might exert favorable effects HFpEF via pulmonary and systemic vasodilation and enhancement of ventricular relaxation. We assessed the safety and efficacy of oral milrinone on quality of life and functional outcomes in patients with HFpEF. Methods and Results The MilHFPEF (Extended Release Oral Milrinone for the Treatment of Heart Failure With Preserved Ejection Fraction) study was a randomized, double-blind, placebo-controlled pilot study in 23 patients with symptomatic HFpEF. Efficacy end points included changes from baseline in Kansas City Cardiomyopathy Questionnaire summary score and 6-minute walk distance. The primary safety end point was the development of clinically significant arrhythmia. The Kansas City Cardiomyopathy Questionnaire score improved significantly in milrinone-treated patients compared with placebo (+10±13 versus -3±15;  P =0.046). Six-minute walk distance also tended to improve in the treatment group compared with placebo (+22 [-8 to 49] versus -47 [-97 to 12];  P =0.092). Heart rate (-1±5 versus -2±9 bpm;  P =0.9) and systolic blood pressure (-3±18 versus +1±12 mm Hg;  P =0.57) were unchanged. Early filling velocity/early mitral annular velocity (-0.3±3.0 versus -1.9±4.8;  P =0.38) was unchanged. One patient in the placebo arm was hospitalized for heart failure. Holter monitoring did not demonstrate evidence of a proarrhythmic effect of milrinone. Conclusions In this novel pilot study, extended release oral milrinone was well tolerated and associated with improved quality of life in patients with HFpEF. Further longer-term studies are warranted to establish the role of this therapeutic approach in HFpEF. Registration URL: https://www.anzctr.org.au/; Unique identifier: ACTRN12616000619448.",2020,The Kansas City Cardiomyopathy Questionnaire score improved significantly in milrinone-treated patients compared with placebo (+10±13 versus -3±15;  P =0.046).,"['Heart Failure With Preserved Ejection Fraction', '23 patients with symptomatic HFpEF', 'patients with HFpEF', 'Heart Failure']","['Milrinone', 'preserved ejection fraction (HFpEF', 'milrinone', 'MilHFPEF', 'placebo']","['Early filling velocity/early mitral annular velocity', 'quality of life', 'Kansas City Cardiomyopathy Questionnaire score', 'Kansas City Cardiomyopathy Questionnaire summary score and 6-minute walk distance', 'heart failure', 'Heart rate', 'systolic blood pressure ', 'safety and efficacy', 'development of clinically significant arrhythmia', 'quality of life and functional outcomes']","[{'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0128513', 'cui_str': 'Milrinone'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0022497', 'cui_str': 'Kansas'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",23.0,0.228525,The Kansas City Cardiomyopathy Questionnaire score improved significantly in milrinone-treated patients compared with placebo (+10±13 versus -3±15;  P =0.046).,"[{'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Nanayakkara', 'Affiliation': 'Department of Cardiology Alfred Hospital Melbourne Australia.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Byrne', 'Affiliation': 'Heart Failure Research Group Baker Heart and Diabetes Institute Melbourne Australia.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Mak', 'Affiliation': 'Department of Cardiology Alfred Hospital Melbourne Australia.'}, {'ForeName': 'Kaye', 'Initials': 'K', 'LastName': 'Carter', 'Affiliation': 'Department of Cardiology Alfred Hospital Melbourne Australia.'}, {'ForeName': 'Eliza', 'Initials': 'E', 'LastName': 'Dean', 'Affiliation': 'Department of Cardiology Alfred Hospital Melbourne Australia.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Kaye', 'Affiliation': 'Department of Cardiology Alfred Hospital Melbourne Australia.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.015026']
2781,32552299,The Effect of Doll Therapy on Agitation and Cognitive State in Institutionalized Patients With Moderate-to-Severe Dementia: A Randomized Controlled Study.,"TRIAL REGISTRATION


ClinicalTrials.gov , ID: NCT04120103 Retrospectively registered on 8 April 2019.",2020,"TRIAL REGISTRATION


ClinicalTrials.gov , ID:",['Institutionalized Patients With Moderate-to-Severe Dementia'],['Doll Therapy'],['Agitation and Cognitive State'],"[{'cui': 'C0562359', 'cui_str': 'Institutionalized'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C1301808', 'cui_str': 'State'}]",,0.202483,"TRIAL REGISTRATION


ClinicalTrials.gov , ID:","[{'ForeName': 'Cemile Kütmeç', 'Initials': 'CK', 'LastName': 'Yilmaz', 'Affiliation': 'Nursing Department, Faculty of Health Science, Aksaray University, Aksaray, Turkey.'}, {'ForeName': 'Güler Duru', 'Initials': 'GD', 'LastName': 'Aşiret', 'Affiliation': 'Nursing Department, Faculty of Health Science, Aksaray University, Aksaray, Turkey.'}]",Journal of geriatric psychiatry and neurology,['10.1177/0891988720933353']
2782,32552310,A randomised phase II trial testing the acceptability and feasibility of a narrative approach to public health communication to increase community engagement with palliative care.,"BACKGROUND


Communities have limited understanding of palliative care, creating barriers to informed choice around consideration of a full range of care options in the event of serious illness. Few empirically tested interventions are available to educate community about palliative care, and ultimately improve timely access to these services.
AIM


To test the acceptability (primary outcome), and feasibility of a narrative approach to public health communication seeking to improve attitudes to possible access to palliative care in the event of serious illness.
DESIGN


Randomised phase II trial with six parallel experimental conditions. Outcomes tested included measures of acceptability, feasibility and change in attitudes to possible access to palliative care post-intervention. Contrasts planned for exploratory testing included format, message content and narrator.
SETTING/PARTICIPANTS


Community-based sample of consecutive English-speaking adults who volunteered their participation in response to a study advertisement distributed online through established community groups.
RESULTS


A narrative approach to public health communication was found to be acceptable to community members, and feasible to deliver online. Exploratory data suggested it immediately improved attitudes towards possible access to palliative care in the event of serious illness, with the narrative detailing a description of the evidence delivered by a healthcare professional appearing to be the most promising strategy.
CONCLUSIONS


This study provides preliminary data to inform a future, longitudinal trial evaluating effectiveness and ultimately other evidence-based, public health approaches to improve community engagement with palliative care. Further studies are required to confirm the generalisability of findings to a broader representative sample and other settings including internationally.",2020,"Exploratory data suggested it immediately improved attitudes towards possible access to palliative care in the event of serious illness, with the narrative detailing a description of the evidence delivered by a healthcare professional appearing to be the most promising strategy.
",['Community-based sample of consecutive English-speaking adults who volunteered their participation in response to a study advertisement distributed online through established community groups'],"['narrative approach to public health communication seeking', 'narrative approach to public health communication']","['acceptability, feasibility and change in attitudes to possible access to palliative care post-intervention']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",6.0,0.0851889,"Exploratory data suggested it immediately improved attitudes towards possible access to palliative care in the event of serious illness, with the narrative detailing a description of the evidence delivered by a healthcare professional appearing to be the most promising strategy.
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Collins', 'Affiliation': ""Department of Medicine, St Vincent's Hospital, The University of Melbourne, Fitzroy, VIC, Australia.""}, {'ForeName': 'Sue-Anne', 'Initials': 'SA', 'LastName': 'McLachlan', 'Affiliation': ""Medical Oncology, St Vincent's Hospital Melbourne, Fitzroy, VIC, Australia.""}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Hill', 'Affiliation': 'Moonshine Agency, Cremorne, VIC, Australia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Collins', 'Affiliation': 'Moonshine Agency, Cremorne, VIC, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Philip', 'Affiliation': ""Department of Medicine, St Vincent's Hospital, The University of Melbourne, Fitzroy, VIC, Australia.""}]",Palliative medicine,['10.1177/0269216320932766']
2783,32552366,Enhancing agency for health providers and pregnant women experiencing intimate partner violence in South Africa.,"Global policy frameworks call for strengthening the role of health systems to address intimate partner violence (IPV) and support women's agency, yet the evidence of health system responses remains slender in low- and middle-income countries (LMICs). In South Africa, 25-35% of pregnant women experience IPV, posing long-term health risks. We utilised agency as a theoretical construct, applying qualitative methods to investigate health professionals' experiences of a randomised controlled trial intervention to address IPV in pregnant women in five antenatal clinics (ANC) in Johannesburg (2011-2016). In-depth interviews ( n  = 16) were supplemented by participant observation, debriefing and field notes. Health providers viewed the intervention as  enhancing health promotion agency  and  advancing help-seeking agency  for IPV-exposed patients. Intervention nurses reported their own  self-efficacy improved , and their  relational and collective agency expanded . On-going supervision, mentorship and feedback were essential to establish the knowledge and skill-building necessary for providers to improve self-efficacy in intervention delivery. Integrating mental health services into primary ANC services is recommended. Findings offer insight into the untapped potential for LMIC health settings to become transformative, gender-responsive social systems, for patients and health professionals, in ways that advance women's agency, health, human rights and SDGs.",2020,"Findings offer insight into the untapped potential for LMIC health settings to become transformative, gender-responsive social systems, for patients and health professionals, in ways that advance women's agency, health, human rights and SDGs.","['pregnant women in five antenatal clinics (ANC) in Johannesburg (2011-2016', 'health providers and pregnant women experiencing intimate partner violence in South Africa']",[],[],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}]",[],[],,0.0228113,"Findings offer insight into the untapped potential for LMIC health settings to become transformative, gender-responsive social systems, for patients and health professionals, in ways that advance women's agency, health, human rights and SDGs.","[{'ForeName': 'Courtenay', 'Initials': 'C', 'LastName': 'Sprague', 'Affiliation': 'Department of Conflict Resolution, Human Security & Global Governance, McCormack Graduate School of Policy and Global Studies, University of Massachusetts Boston, Boston, MA, USA.'}, {'ForeName': 'Nataly', 'Initials': 'N', 'LastName': 'Woollett', 'Affiliation': 'School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Abigail M', 'Initials': 'AM', 'LastName': 'Hatcher', 'Affiliation': 'School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}]",Global public health,['10.1080/17441692.2020.1780290']
2784,32552387,Aspirin enhances the clinical efficacy of anti-tuberculosis therapy in pulmonary tuberculosis in patients with type 2 diabetes mellitus.,"Background:  Tuberculosis in patients with diabetes mellitus is characterised by rapid disease progression, poor treatment efficacy, poor prognosis and poses a new challenge in tuberculosis treatment and control. Methods:  Patients with pulmonary TB and type 2 DM were recruited at Yijishan Hospital of Wannan Medical College. A total of 348 patients were randomly assigned to two groups. The aspirin group (aspirin + TB/DM) included 174 patients who received anti-TB therapy and enteric-coated aspirin tablets (100 mg/tablet). The control group (placebo + TB/DM) included 174 patients who received anti-TB therapy and enteric-coated placebo tablets (an identical tablet containing no drug). Eighty-two patients in the aspirin group and 86 in the control group completed the trial and were included in the analysis. Clinical characteristics, laboratory test results, imaging data and side effects of aspirin were monitored. Results:  Aspirin treatment affect certain signs and symptoms. The erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) levels were lower in the aspirin group than in the control group after treatment (Both  p  = .000). The sputum-negative conversion rate was 86.7% in the aspirin group, significantly higher than in the control group (53.8%) ( p  = .031). After two months of treatment, the differences in the number of cases with cavities, the number of cavities, and maximum diameter of cavities in the aspirin group were statistically significant ( p  = .003,  p  = .023 and  p  = .015 respectively). Conclusion:  Our findings suggest that aspirin may improve treatment in patients with pulmonary TB and type 2 DM.",2020,The erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) levels were lower in the aspirin group than in the control group after treatment (,"['348 patients', 'patients with type 2 diabetes mellitus', '174 patients who received', 'patients with diabetes mellitus', 'patients with pulmonary TB and type 2\u2009DM', 'Patients with pulmonary TB and type 2\u2009DM were recruited at Yijishan Hospital of Wannan Medical College', 'an identical tablet containing no drug', '174 patients who received anti-TB therapy and enteric-coated aspirin tablets (100\u2009mg/tablet']","['control group (placebo\u2009+\u2009TB/DM', 'anti-tuberculosis therapy', 'Aspirin', 'aspirin group (aspirin\u2009+\u2009TB/DM', 'aspirin', 'anti-TB therapy and enteric-coated placebo tablets']","['certain signs and symptoms', 'sputum-negative conversion rate', 'number of cases with cavities, the number of cavities, and maximum diameter of cavities', 'erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) levels']","[{'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C1244632', 'cui_str': 'Aspirin Oral Tablet'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}]",348.0,0.0578305,The erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) levels were lower in the aspirin group than in the control group after treatment (,"[{'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Infectious Diseases, Yijishan Hospital of Wannan Medical College, Wuhu, P. R. China.'}, {'ForeName': 'Zhixiang', 'Initials': 'Z', 'LastName': 'Du', 'Affiliation': ""Department of Infectious Diseases, The People's Hospital of Taizhou, Taizhou, P. R. China.""}, {'ForeName': 'Mingyue', 'Initials': 'M', 'LastName': 'Ni', 'Affiliation': 'Department of Infectious Diseases, Yijishan Hospital of Wannan Medical College, Wuhu, P. R. China.'}, {'ForeName': 'Zijian', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Infectious Diseases, Yijishan Hospital of Wannan Medical College, Wuhu, P. R. China.'}, {'ForeName': 'Manman', 'Initials': 'M', 'LastName': 'Liang', 'Affiliation': 'Department of Infectious Diseases, Yijishan Hospital of Wannan Medical College, Wuhu, P. R. China.'}, {'ForeName': 'Haoyu', 'Initials': 'H', 'LastName': 'Sheng', 'Affiliation': 'Department of Infectious Diseases, Yijishan Hospital of Wannan Medical College, Wuhu, P. R. China.'}, {'ForeName': 'Aiping', 'Initials': 'A', 'LastName': 'Zhang', 'Affiliation': 'Department of Infectious Diseases, Yijishan Hospital of Wannan Medical College, Wuhu, P. R. China.'}, {'ForeName': 'Jianghua', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Infectious Diseases, Yijishan Hospital of Wannan Medical College, Wuhu, P. R. China.'}]","Infectious diseases (London, England)",['10.1080/23744235.2020.1778177']
2785,32552523,Cooling as an Adjunctive Therapy to Percutaneous Intervention in Acute Myocardial Infarction: COOL-MI InCor Trial.,"Endovascular Therapeutic hypothermia (ETH) reduces the damage caused by postischemia reperfusion injury syndrome in cardiopulmonary arrest and has already established its role in patients with sudden death; however, its role in ST-segment elevation myocardial infarction (STEMI) remains controversial. The objectives of this study were to investigate the safety, feasibility, and 30-day efficacy of rapid induction of therapeutic hypothermia as adjunctive therapy to percutaneous coronary intervention (PCI) in patients with anterior and inferior STEMIs. This was a prospective, controlled, randomized, two-arm, prospective, interventional study of patients admitted to the emergency department within 6 hours of angina onset, with anterior or inferior STEMI eligible for PCI. Subjects were randomized to the hypothermia group (primary PCI+ETH) or to the control group (primary PCI) at a 4:1 ratio. The ETH was induced by 1 L cold saline (1-4°C) associated with the Proteus™ System, by cooling for at least 18 minutes before coronary reperfusion with a target temperature of 32°C ± 1°C. Maintenance of ETH was conducted for 1-3 hours, and active reheating was done at a rate of 1°C/h for 4 hours. Primary safety outcomes were the feasibility of ETH in the absence of (1) door-to-balloon (DTB) delay; (2) major adverse cardiac events (MACE) within 30 days after randomization. The primary outcomes of effectiveness were infarct size (IS) and left ventricular ejection fraction (LVEF) at 30 days. An as-treated statistical analysis was performed. Fifty patients were included: 35 (70%) randomized to the hypothermia group and 15 (30%) to the control group. The mean age was 58 ± 12 years; 78% were men; and associated diseases were 60% hypertension, 42% diabetes, and 72% dyslipidemia. The compromised myocardial wall was anterior in 38% and inferior in 62%, and the culprit vessels were left anterior descending artery (LAD) (40%), right coronary artery (38%), and left circumflex (18%). All 35 patients who attempted ETH (100%) had successful cooling, with a mean endovascular coronary reperfusion temperature of 33.1°C ± 0.9°C. The mean ischemic time was 375 ± 89.4 minutes in the hypothermia group and 359.5 ± 99.4 minutes in the control group. The mean DTB was 92.1 ± 20.5 minutes in the hypothermia group and 87 ± 24.4 minutes in the control group. The absolute difference of 5.1 minutes was not statistically significant ( p  = 0.509). The MACE rates were similar between both groups (21.7% vs. 20% respectively,  p  = 0.237). In the comparison between the hypothermia and control groups, no statistically significant differences were observed at 30 days between mean IS (13.9% ± 8% vs. 13.8% ± 10.8%, respectively,  p  = 0.801) and mean final LVEF (43.3% ± 11.2% vs. 48.3 ± 10.9%, respectively;  p  = 0.194). Hypothermia as an adjunctive therapy to primary PCI in STEMI is feasible and can be implemented without delay in coronary reperfusion. Hypothermia was safe regarding the incidence of MACE at 30 days. However, there was a higher incidence of arrhythmia and in-hospital infection in the hypothermia group, with no increase in mortality. Regarding efficacy, there was no difference in IS or LVEF at 30 days that would suggest additional myocardial protection with ETH. ClinicalTrials.gov: NCT02664194.",2020,"The MACE rates were similar between both groups (21.7% vs. 20% respectively,  p  = 0.237).","['All 35 patients who attempted ETH (100%) had successful cooling, with a mean endovascular coronary reperfusion temperature of 33.1°C\u2009±\u20090.9°C', 'patients admitted to the emergency department within 6 hours of angina onset, with anterior or inferior STEMI eligible for PCI', 'Fifty patients were included: 35 (70%) randomized to the', 'patients with sudden death', 'Acute Myocardial Infarction', 'patients with anterior and inferior STEMIs', 'The mean age was 58\u2009±\u200912 years; 78% were men; and associated diseases were 60% hypertension, 42% diabetes, and 72% dyslipidemia']","['percutaneous coronary intervention (PCI', 'hypothermia', 'Percutaneous Intervention', 'Endovascular Therapeutic hypothermia (ETH', 'hypothermia group (primary PCI+ETH', 'control group (primary PCI']","['arrhythmia and in-hospital infection', 'MACE rates', 'mean DTB', 'mean ischemic time', 'mean final LVEF', 'mortality', 'safety, feasibility, and 30-day efficacy', 'feasibility of ETH in the absence of (1) door-to-balloon (DTB) delay; (2) major adverse cardiac events (MACE', 'infarct size (IS) and left ventricular ejection fraction (LVEF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020674', 'cui_str': 'Induction of hypothermia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0027054', 'cui_str': 'Reperfusion, Myocardial'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C1292428', 'cui_str': '6 hours'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011071', 'cui_str': 'Sudden death'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0020674', 'cui_str': 'Induction of hypothermia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0557698', 'cui_str': 'Door'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0020674', 'cui_str': 'Induction of hypothermia'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}]",50.0,0.0457433,"The MACE rates were similar between both groups (21.7% vs. 20% respectively,  p  = 0.237).","[{'ForeName': 'Luis Augusto Palma', 'Initials': 'LAP', 'LastName': 'Dallan', 'Affiliation': 'Department of Cardiology, InCor, Heart Institute, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Natali Schiavo', 'Initials': 'NS', 'LastName': 'Giannetti', 'Affiliation': 'Department of Cardiology, InCor, Heart Institute, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Carlos Eduardo', 'Initials': 'CE', 'LastName': 'Rochitte', 'Affiliation': 'Department of Cardiology, InCor, Heart Institute, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Thatiane Facholi', 'Initials': 'TF', 'LastName': 'Polastri', 'Affiliation': 'Department of Cardiology, InCor, Heart Institute, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Claudia Yanet Bernoche', 'Initials': 'CYB', 'LastName': 'San Martin', 'Affiliation': 'Department of Cardiology, InCor, Heart Institute, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Ludhmila Abrahao', 'Initials': 'LA', 'LastName': 'Hajjar', 'Affiliation': 'Department of Cardiology, InCor, Heart Institute, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Jose Carlos', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Department of Cardiology, InCor, Heart Institute, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Mucio Tavares de', 'Initials': 'MT', 'LastName': 'Oliveira', 'Affiliation': 'Department of Cardiology, InCor, Heart Institute, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dae', 'Affiliation': 'Department of Radiology, UCSF, University of California, San Francisco, California, USA.'}, {'ForeName': 'Expedito Eustaquio', 'Initials': 'EE', 'LastName': 'Ribeiro da Silva', 'Affiliation': 'Department of Cardiology, InCor, Heart Institute, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Kalil Filho', 'Affiliation': 'Department of Cardiology, InCor, Heart Institute, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Pedro Alves', 'Initials': 'PA', 'LastName': 'Lemos Neto', 'Affiliation': 'Department of Cardiology, InCor, Heart Institute, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Timerman', 'Affiliation': 'Department of Cardiology, InCor, Heart Institute, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}]",Therapeutic hypothermia and temperature management,['10.1089/ther.2020.0018']
2786,32552530,The impact of laughter yoga on depression and anxiety among retired women: a randomized controlled clinical trial.,"Recently, laughter yoga (LY) has been introduced for managing depression and anxiety. This study aimed to investigate the impact of LY on depression and anxiety among retired women in city of Bojnurd, Iran, 2018. Sixty-six retired women were randomly assigned to intervention and control groups. Intervention group received LY twice weekly for 8 weeks; control group had their routine daily activities. Depression and anxiety levels were measured at study initiation, week 4, and week 8 in both groups. Results showed significant difference in the pattern of depression ( p  <.001) and anxiety ( p  <.001) scores within and between groups. LY could be an effective intervention in reducing depression and anxiety among retired women.",2020,Results showed significant difference in the pattern of depression ( p  <.001) and anxiety ( p  <.001) scores within and between groups.,"['Sixty-six retired women', 'retired women in city of Bojnurd, Iran, 2018', 'retired women']","['laughter yoga (LY', 'laughter yoga']","['Depression and anxiety levels', 'depression and anxiety', 'anxiety', 'pattern of depression']","[{'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035345', 'cui_str': 'Retired'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C4045984', 'cui_str': 'Laughter Yoga'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",66.0,0.0510618,Results showed significant difference in the pattern of depression ( p  <.001) and anxiety ( p  <.001) scores within and between groups.,"[{'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Armat', 'Affiliation': 'Geriatric Care Research Center, Department of Medical-Surgical Nursing, School of Nursing and Midwifery, North Khorasan University of Medical Sciences , Bojnurd, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Emami Zeydi', 'Affiliation': 'Department of Medical-Surgical Nursing, Nasibeh School of Nursing and Midwifery, Mazandaran University of Medical Sciences , Sari, Iran.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Mokarami', 'Affiliation': 'Student Research Committee, School of Nursing and Midwifery, North Khorasan University of Medical Sciences , Bojnurd, Iran.'}, {'ForeName': 'Ailar', 'Initials': 'A', 'LastName': 'Nakhlband', 'Affiliation': 'Natural Products and Medicinal Plants Research Center, North Khorasan University of Medical Sciences , Bojnurd, Iran.'}, {'ForeName': 'Seyed Kaveh', 'Initials': 'SK', 'LastName': 'Hojjat', 'Affiliation': 'Addiction and Behavioral Sciences Research Center, North Khorasan University of Medical Sciences , Bojnurd, Iran.'}]",Journal of women & aging,['10.1080/08952841.2020.1774225']
2787,32552582,The influence of an 11-week resisted swim training program on the inter-arm coordination in front crawl swimmers.,"The purpose was to assess the effect of an 11-week resisted swim training program using a water parachute on the inter-arm coordination in front crawl swimming. Fourteen female swimmers were divided into a control and an experimental group, and followed the same training program, except for the use of a water parachute by the experimental group in specific sprint sets. Before and after the intervention, the underwater motion of the swimmers was recorded using four camcorders and the digitisation process was undertaken manually. The two-way repeated measures analyses of variance revealed a significant increase of the swimming velocity, due to a significant increased stroke rate, because of the significant reduction of the total stroke duration, only in the experimental group. Moreover, their absolute and relative duration of the propulsive pull and push phases increased significantly, while the absolute and relative duration of their non-propulsive entry & catch and recovery phases decreased significantly. These modifications caused a significant increase in the index of coordination. Thus, this 11-week sprint resisted intervention program seems to improve the propulsion continuity and could be considered as an effective form of training, increasing the stroke rate and consequently the swimming velocity.",2020,"The two-way repeated measures analyses of variance revealed a significant increase of the swimming velocity, due to a significant increased stroke rate, because of the significant reduction of the total stroke duration, only in the experimental group.","['front crawl swimmers', 'Fourteen female swimmers']",['11-week resisted swim training program'],"['swimming velocity', 'index of coordination', 'absolute and relative duration of their non-propulsive entry & catch and recovery phases', 'stroke rate', 'total stroke duration']","[{'cui': 'C0235042', 'cui_str': 'Does crawl'}, {'cui': 'C0450068', 'cui_str': 'Swimmer'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3653283', 'cui_str': 'PROPULSIVES'}, {'cui': 'C0231617', 'cui_str': 'Catch'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",14.0,0.0119901,"The two-way repeated measures analyses of variance revealed a significant increase of the swimming velocity, due to a significant increased stroke rate, because of the significant reduction of the total stroke duration, only in the experimental group.","[{'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Valkoumas', 'Affiliation': 'Department of Physical Education and Sports Science, School of Physical Education and Sports Science, Democritus University of Thrace , Komotini, Greece.'}, {'ForeName': 'Vassilios', 'Initials': 'V', 'LastName': 'Gourgoulis', 'Affiliation': 'Department of Physical Education and Sports Science, School of Physical Education and Sports Science, Democritus University of Thrace , Komotini, Greece.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Aggeloussis', 'Affiliation': 'Department of Physical Education and Sports Science, School of Physical Education and Sports Science, Democritus University of Thrace , Komotini, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Antoniou', 'Affiliation': 'Department of Physical Education and Sports Science, School of Physical Education and Sports Science, Democritus University of Thrace , Komotini, Greece.'}]",Sports biomechanics,['10.1080/14763141.2020.1770324']
2788,32552691,Modified-ramped position: a new position for intubation of obese females: a randomized controlled pilot study.,"BACKGROUND


Endotracheal intubation requires optimum position of the head and neck. In obese females, the usual ramped position might not provide adequate intubating conditions. We hypothesized that a new position, termed modified-ramped position, during induction of anesthesia would facilitate endotracheal intubation through bringing the breasts away from the laryngoscope and would also improve the laryngeal visualization.
METHODS


Sixty obese female patients scheduled for general anesthesia were randomly assigned into either ramped or modified-ramped position during induction of anesthesia. In the ramped position (n = 30), the patient head and shoulders were elevated to achieve alignment of the sternal notch and the external auditory meatus; while in the modified-ramped position (n = 30), the patient shoulders were elevated using a special pillow, and the head was extended to the most possible range. Our primary outcome was the incidence of failed laryngoscopic insertion in the oral cavity (the need for patient repositioning). Other outcomes included time till vocal cord visualization, time till successful endotracheal intubation, difficulty of the mask ventilation, and Cormack-Lehane grade for laryngeal view.
RESULTS


Fourteen patients (47%) in ramped group required repositioning to facilitate introduction of the laryngoscope in the oral cavity in comparison to one patient (3%) in the modified-ramped position (p < 0.001). Modified-ramped position showed lower incidence of difficult mask ventilation, shorter time for glottic visualization, and shorter time for endotracheal tube insertion compared to the ramped position. The Cormack-Lehane grade was better in the modified-ramped position.
CONCLUSION


Modified-ramped position provided better intubating conditions, improved the laryngeal view, and eliminated the need for repositioning of obese female patients during insertion of the laryngoscope compared to ramped position.
CLINICAL TRIAL REGISTRATION


Identifier: NCT03640442. Date: August 2018.",2020,"RESULTS


Fourteen patients (47%) in ramped group required repositioning to facilitate introduction of the laryngoscope in the oral cavity in comparison to one patient (3%) in the modified-ramped position (p < 0.001).","['obese females', 'obese female patients', 'Sixty obese female patients scheduled for general anesthesia']","['ramped or modified-ramped position during induction of anesthesia', 'Modified-ramped position']","['time till vocal cord visualization, time till successful endotracheal intubation, difficulty of the mask ventilation, and Cormack-Lehane grade for laryngeal view', 'incidence of failed laryngoscopic insertion in the oral cavity (the need for patient repositioning', 'incidence of difficult mask ventilation, shorter time for glottic visualization, and shorter time for endotracheal tube insertion']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0034646', 'cui_str': 'Ramp'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042930', 'cui_str': 'Vocal cord structure'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C2362912', 'cui_str': 'Patient Moving and Lifting'}, {'cui': 'C4706398', 'cui_str': 'Difficult mask ventilation'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure'}]",60.0,0.0652977,"RESULTS


Fourteen patients (47%) in ramped group required repositioning to facilitate introduction of the laryngoscope in the oral cavity in comparison to one patient (3%) in the modified-ramped position (p < 0.001).","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hasanin', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Giza, Egypt. ahmedmohamedhasanin@gmail.com.'}, {'ForeName': 'Hager', 'Initials': 'H', 'LastName': 'Tarek', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Giza, Egypt.'}, {'ForeName': 'Maha M A', 'Initials': 'MMA', 'LastName': 'Mostafa', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Giza, Egypt.'}, {'ForeName': 'Amany', 'Initials': 'A', 'LastName': 'Arafa', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Giza, Egypt.'}, {'ForeName': 'Ahmed G', 'Initials': 'AG', 'LastName': 'Safina', 'Affiliation': 'Department of surgery, Cairo university, Giza, Egypt.'}, {'ForeName': 'Mona H', 'Initials': 'MH', 'LastName': 'Elsherbiny', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Giza, Egypt.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Hosny', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Giza, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Gado', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Giza, Egypt.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Almenesey', 'Affiliation': 'Department of anesthesia and critical care medicine, Beni suef university, Beni suef, Egypt.'}, {'ForeName': 'Ghada Adel', 'Initials': 'GA', 'LastName': 'Hamden', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Giza, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Mahmoud', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Giza, Egypt.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Amin', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Giza, Egypt.'}]",BMC anesthesiology,['10.1186/s12871-020-01070-2']
2789,32552782,The effect of low- versus normal-pressure pneumoperitoneum during laparoscopic colorectal surgery on the early quality of recovery with perioperative care according to the enhanced recovery principles (RECOVER): study protocol for a randomized controlled study.,"BACKGROUND


There is increasing evidence for the use of lower insufflation pressures during laparoscopic surgery. Deep neuromuscular blockade allows for a safe reduction in intra-abdominal pressure without compromising the quality of the surgical field. While there is considerable evidence to support superior surgical conditions during deep neuromuscular blockade, there is only a limited amount of studies investigating patient outcomes. Moreover, results are not always consistent between studies and vary between different types of laparoscopic surgery. This study will investigate the effect of low-pressure pneumoperitoneum facilitated by deep NMB on quality of recovery after laparoscopic colorectal surgery.
METHODS


The RECOVER study is a multicenter double-blinded randomized controlled trial consisting of 204 patients who will be randomized in a 1:1 fashion to group A, low-pressure pneumoperitoneum (8 mmHg) facilitated by deep neuromuscular blockade (post tetanic count of 1-2), or group B, normal-pressure pneumoperitoneum (12 mmHg) with moderate neuromuscular blockade (train-of-four response of 1-2). The primary outcome is quality of recovery on postoperative day 1, quantified by the Quality of Recovery-40 questionnaire.
DISCUSSION


Few studies have investigated the effect of lower insufflation pressures facilitated by deep neuromuscular blockade on patient outcomes after laparoscopic colorectal procedures. This study will identify whether low pressure pneumoperitoneum and deep neuromuscular blockade will enhance recovery after colorectal laparoscopic surgery and, moreover, if this could be a valuable addition to the Enhanced Recovery After Surgery guidelines.
TRIAL REGISTRATION


EudraCT 2018-001485-42. Registered on April 9, 2018. Clinicaltrials.govNCT03608436. Registered on July 30, 2018.",2020,Few studies have investigated the effect of lower insufflation pressures facilitated by deep neuromuscular blockade on patient outcomes after laparoscopic colorectal procedures.,['204 patients who will be randomized in a 1:1 fashion to group A'],"['low- versus normal-pressure pneumoperitoneum', 'laparoscopic colorectal surgery', 'low-pressure pneumoperitoneum (8\u2009mmHg) facilitated by deep neuromuscular blockade (post tetanic count of 1-2), or group B, normal-pressure pneumoperitoneum (12\u2009mmHg) with moderate neuromuscular blockade (train-of-four response of 1-2', 'low-pressure pneumoperitoneum facilitated by deep NMB']","['quality of recovery on postoperative day 1, quantified by the Quality of Recovery-40 questionnaire', 'quality of recovery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0234119', 'cui_str': 'Neuromuscular blockade'}, {'cui': 'C0428701', 'cui_str': 'Post-tetanic count'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0068601', 'cui_str': 'neuromedin B'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.554078,Few studies have investigated the effect of lower insufflation pressures facilitated by deep neuromuscular blockade on patient outcomes after laparoscopic colorectal procedures.,"[{'ForeName': 'Kim I', 'Initials': 'KI', 'LastName': 'Albers', 'Affiliation': 'Department of Surgery and Anesthesiology, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, The Netherlands. Kim.Albers@radboudumc.nl.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Polat', 'Affiliation': 'Department of Surgery, Canisius Wilhelmina Hospital, Weg door Jonkerbos 100, 6532 SZ, Nijmegen, The Netherlands.'}, {'ForeName': 'Ivo F', 'Initials': 'IF', 'LastName': 'Panhuizen', 'Affiliation': 'Department of Anesthesiology, Canisius Wilhelmina Hospital, Weg door Jonkerbos 100, 6532 SZ, Nijmegen, The Netherlands.'}, {'ForeName': 'Marc M J', 'Initials': 'MMJ', 'LastName': 'Snoeck', 'Affiliation': 'Department of Anesthesiology, Canisius Wilhelmina Hospital, Weg door Jonkerbos 100, 6532 SZ, Nijmegen, The Netherlands.'}, {'ForeName': 'Gert-Jan', 'Initials': 'GJ', 'LastName': 'Scheffer', 'Affiliation': 'Department of Anesthesiology, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Hans D', 'Initials': 'HD', 'LastName': 'de Boer', 'Affiliation': 'Department of Anesthesiology, Martini General Hospital, Van Swietenplein 1, 9728 NT, Groningen, The Netherlands.'}, {'ForeName': 'Michiel C', 'Initials': 'MC', 'LastName': 'Warlé', 'Affiliation': 'Department of Surgery, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, The Netherlands.'}]",Trials,['10.1186/s13063-020-04496-8']
2790,32552784,Exploring characteristics of COPD patients with clinical improvement after integrated disease management or usual care: post-hoc analysis of the RECODE study.,"BACKGROUND


The cluster randomized controlled trial on (cost-)effectiveness of integrated chronic obstructive pulmonary disease (COPD) management in primary care (RECODE) showed that integrated disease management (IDM) in primary care had no effect on quality of life (QOL) in COPD patients compared with usual care (guideline-supported non-programmatic care). It is possible that only a subset of COPD patients in primary care benefit from IDM. We therefore examined which patients benefit from IDM, and whether patient characteristics predict clinical improvement over time.
METHOD


Post-hoc analyses of the RECODE trial among 1086 COPD patients. Logistic regression analyses were performed with baseline characteristics as predictors to examine determinants of improvement in QOL, defined as a minimal decline in Clinical COPD Questionnaire (CCQ) of 0.4 points after 12 and 24 months of IDM. We also performed moderation analyses to examine whether predictors of clinical improvement differed between IDM and usual care.
RESULTS


Regardless of treatment type, more severe dyspnea (MRC) was the most important predictor of clinically improved QOL at 12 and 24 months, suggesting that these patients have most room for improvement. Clinical improvement with IDM was associated with female gender (12-months) and being younger (24-months), and improvement with usual care was associated with having a depression (24-months).
CONCLUSIONS


More severe dyspnea is a key predictor of improved QOL in COPD patients over time. More research is needed to replicate patient characteristics associated with clinical improvement with IDM, such that IDM programs can be offered to patients that benefit the most, and can potentially be adjusted to meet the needs of other patient groups as well.
TRIAL REGISTRATION


Netherlands Trial Register, NTR2268. Registered 31 March 2010.",2020,"Clinical improvement with IDM was associated with female gender (12-months) and being younger (24-months), and improvement with usual care was associated with having a depression (24-months).
","['COPD patients with clinical improvement after integrated disease management or usual care', '1086 COPD patients']",[],"['quality of life (QOL', 'QOL', 'Clinical COPD Questionnaire (CCQ', 'severe dyspnea (MRC']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],"[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2919593', 'cui_str': 'Clinical chronic obstructive pulmonary disease questionnaire'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}]",1086.0,0.0920091,"Clinical improvement with IDM was associated with female gender (12-months) and being younger (24-months), and improvement with usual care was associated with having a depression (24-months).
","[{'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Meijer', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Centre, PO Box 9600, 2300 RC, Leiden, Netherlands. E.Meijer@lumc.nl.'}, {'ForeName': 'Annelies E', 'Initials': 'AE', 'LastName': 'van Eeden', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Centre, PO Box 9600, 2300 RC, Leiden, Netherlands.'}, {'ForeName': 'Annemarije L', 'Initials': 'AL', 'LastName': 'Kruis', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Centre, PO Box 9600, 2300 RC, Leiden, Netherlands.'}, {'ForeName': 'Melinde R S', 'Initials': 'MRS', 'LastName': 'Boland', 'Affiliation': 'Institute of Health, Policy & Management, Erasmus University Rotterdam, PO Box 1738, 3000 DR, Rotterdam, Netherlands.'}, {'ForeName': 'Willem J J', 'Initials': 'WJJ', 'LastName': 'Assendelft', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Centre, 6500 HB, Nijmegen, Netherlands.'}, {'ForeName': 'Apostolos', 'Initials': 'A', 'LastName': 'Tsiachristas', 'Affiliation': 'Institute of Health, Policy & Management, Erasmus University Rotterdam, PO Box 1738, 3000 DR, Rotterdam, Netherlands.'}, {'ForeName': 'Maureen P M H', 'Initials': 'MPMH', 'LastName': 'Rutten-van Mölken', 'Affiliation': 'Institute of Health, Policy & Management, Erasmus University Rotterdam, PO Box 1738, 3000 DR, Rotterdam, Netherlands.'}, {'ForeName': 'Marise J', 'Initials': 'MJ', 'LastName': 'Kasteleyn', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Centre, PO Box 9600, 2300 RC, Leiden, Netherlands.'}, {'ForeName': 'Niels H', 'Initials': 'NH', 'LastName': 'Chavannes', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Centre, PO Box 9600, 2300 RC, Leiden, Netherlands.'}]",BMC pulmonary medicine,['10.1186/s12890-020-01213-8']
2791,32552805,"Comparing video-based versions of Halsted's 'see one, do one' and Peyton's '4-step approach' for teaching surgical skills: a randomized controlled trial.","BACKGROUND


Teaching complex motor skills at a high level remains a challenge in medical education. Established methods often involve large amounts of teaching time and material. The implementation of standardized videos in those methods might help save resources. In this study, video-based versions of Peyton's '4-step Approach' and Halsted's 'See One, Do One' are compared. We hypothesized that the video-based '4-step Approach' would be more effective in learning procedural skills than the 'See One, Do One Approach'.
METHODS


One-hundred-two naïve students were trained to perform a structured facial examination and a Bellocq's tamponade with either Halsted's (n = 57) or Peyton's (n = 45) method within a curricular course. Steps 1 (Halsted) and 1-3 (Peyton) were replaced by standardized teaching videos. The performance was measured directly (T1) and 8 weeks (T2) after the intervention by blinded examiners using structured checklists. An item-analysis was also carried out.
RESULTS


At T1, performance scores significantly differed in favor of the video-based '4-step Approach' (p < 0.01) for both skills. No differences were found at T2 (p < 0.362). The item-analysis revealed that Peyton's method was significantly more effective in the complex subparts of both skills.
CONCLUSIONS


The modified video-based version of Peyton's '4-step Approach' is the preferred method for teaching especially complex motor skills in a large curricular scale. Furthermore, an effective way to utilize Peyton's method in a group setting could be demonstrated. Further studies have to investigate the long-term learning retention of this method in a formative setting.",2020,"At T1, performance scores significantly differed in favor of the video-based '4-step Approach' (p < 0.01) for both skills.",['One-hundred-two naïve'],"[""structured facial examination and a Bellocq's tamponade with either Halsted's (n\u2009=\u200957) or Peyton's""]",[],"[{'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332459', 'cui_str': 'Compression'}]",[],102.0,0.0690792,"At T1, performance scores significantly differed in favor of the video-based '4-step Approach' (p < 0.01) for both skills.","[{'ForeName': 'Lukas B', 'Initials': 'LB', 'LastName': 'Seifert', 'Affiliation': 'Department of Oral, Cranio-Maxillofacial, and Facial Plastic Surgery, University Hospital Frankfurt, Goethe University, Theodor-Stern-Kai 7, 60590, Frankfurt, Germany. lukasbenedikt.seifert@kgu.de.'}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Schnurr', 'Affiliation': 'Department of Oral, Cranio-Maxillofacial, and Facial Plastic Surgery, University Hospital Frankfurt, Goethe University, Theodor-Stern-Kai 7, 60590, Frankfurt, Germany.'}, {'ForeName': 'Maria-Christina', 'Initials': 'MC', 'LastName': 'Stefanescu', 'Affiliation': 'Department of Pediatric Surgery and Pediatric Urology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Sader', 'Affiliation': 'Department of Oral, Cranio-Maxillofacial, and Facial Plastic Surgery, University Hospital Frankfurt, Goethe University, Theodor-Stern-Kai 7, 60590, Frankfurt, Germany.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Ruesseler', 'Affiliation': 'Department of Trauma, Reconstructive and Hand Surgery, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Jasmina', 'Initials': 'J', 'LastName': 'Sterz', 'Affiliation': 'Department of Trauma, Reconstructive and Hand Surgery, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}]",BMC medical education,['10.1186/s12909-020-02105-5']
2792,32552828,Conversion of I-gel to definitive airway in a cervical immobilized manikin: Aintree intubation catheter vs long endotracheal tube.,"BACKGROUND


After prehospital insertion of i-gel, a popular supraglottic airway (SGA), fiberoptic-guided intubation through i-gel is often required to switch the i-gel to a definitive airway for anticipated difficult airway. The Aintree intubation catheter (AIC) was developed for this purpose yet it requires many procedural steps during which maintenance of adequate ventilation is difficult. We custom-made a long endotracheal tube (LET) which may facilitate this procedure and compared the efficacy of the AIC and LET in a cervical immobilized manikin.
METHODS


In this 2 × 2 crossover manikin-based trial, 20 anaesthesiologists and residents performed both methods in random order. Total intubation time, fiberoptic time, and procedure time were recorded. The ease of insertion, procedure failure rate, difficulty score, and participants' preference were recorded.
RESULTS


Total intubation time was significantly shorter for the LET than the AIC group (70.8 ± 16.4 s vs 94.0 ± 28.4 s, P = 0.001). The procedure time was significantly shorter in the LET group (51.9 ± 13.8 s vs 76.5 ± 25.4 s, P <  0.001). The ease of insertion score was lower, i.e., easier, in the AIC than the LET group (2.0 [1.0-2.75] vs 1.0 [1.0-1.0], P <  0.001). Fiberoptic time (19.0 ± 6.9 s vs 17.5 ± 12.3 s) and subjective difficulty (4.0 [3.0-6.0] vs 4.0 [3.0-5.75]) were similar between groups. Fourteen participants preferred the LET method (70%) due to its fewer procedural steps.
CONCLUSIONS


LET resulted in a shorter intubation time than the AIC during fiberoptic-guided intubation through the i-gel, possibly due to the less procedural steps compared to AIC.
TRIAL REGISTRATION


NCT03645174 (ClinicalTrials.gov, Aug 22, 2018).",2020,"RESULTS


Total intubation time was significantly shorter for the LET than the AIC group (70.8 ± 16.4 s vs 94.0 ± 28.4 s, P = 0.001).",[],"['custom-made a long endotracheal tube (LET', 'LET', 'Aintree intubation catheter (AIC']","['Fiberoptic time', 'procedure time', 'subjective difficulty', 'Total intubation time', 'shorter intubation time', 'ease of insertion score', 'Total intubation time, fiberoptic time, and procedure time']",[],"[{'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",20.0,0.129802,"RESULTS


Total intubation time was significantly shorter for the LET than the AIC group (70.8 ± 16.4 s vs 94.0 ± 28.4 s, P = 0.001).","[{'ForeName': 'Yun Jeong', 'Initials': 'YJ', 'LastName': 'Chae', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, 16499, South Korea.'}, {'ForeName': 'Heirim', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Office of Biostatics, Ajou Research Institute for Innovative Medicine, Ajou University Medical Center, 164, World cup-ro, Yeongtong-gu, Suwon, 16499, South Korea.'}, {'ForeName': 'Bokyeong', 'Initials': 'B', 'LastName': 'Jun', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, 16499, South Korea.'}, {'ForeName': 'In Kyong', 'Initials': 'IK', 'LastName': 'Yi', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, 16499, South Korea. lyrin01@gmail.com.'}]",BMC anesthesiology,['10.1186/s12871-020-01069-9']
2793,32552839,Statistical analysis plan for a cluster-randomised trial assessing the effectiveness of implementation of a bedside evidence-based checklist for clinical management of brain-dead potential organ donors in intensive care units: DONORS (Donation Network to Optimise Organ Recovery Study).,"BACKGROUND


The quality of clinical care of brain-dead potential organ donors may help reduce donor losses caused by irreversible or unreversed cardiac arrest and increase the number of organs donated. We sought to determine whether an evidence-based, goal-directed checklist for donor management in intensive care units (ICUs) can reduce donor losses to cardiac arrest.
METHODS/DESIGN


The DONORS study is a multicentre, cluster-randomised controlled trial with a 1:1 allocation ratio designed to compare an intervention group (goal-directed checklist for brain-dead potential organ donor management) with a control group (standard ICU care). The primary outcome is loss of potential donors due to cardiac arrest. Secondary outcomes are the number of actual organ donors and the number of solid organs recovered per actual donor. Exploratory outcomes include the achievement of relevant clinical goals during the management of brain-dead potential organ donors. The present statistical analysis plan (SAP) describes all primary statistical procedures that will be used to evaluate the results and perform exploratory and sensitivity analyses of the trial.
DISCUSSION


The SAP of the DONORS study aims to describe its analytic procedures, enhancing the transparency of the study. At the moment of SAP subsmission, 63 institutions have been randomised and were enrolling study participants. Thus, the analyses reported herein have been defined before the end of the study recruitment and database locking.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03179020. Registered on 7 June 2017.",2020,"The DONORS study is a multicentre, cluster-randomised controlled trial with a 1:1 allocation ratio designed to compare an intervention group (goal-directed checklist for brain-dead potential organ donor management) with a control group (standard ICU care).",[],"['bedside evidence-based checklist', 'intervention group (goal-directed checklist for brain-dead potential organ donor management) with a control group (standard ICU care']","['number of actual organ donors and the number of solid organs recovered per actual donor', 'achievement of relevant clinical goals during the management of brain-dead potential organ donors', 'loss of potential donors due to cardiac arrest']",[],"[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0006110', 'cui_str': 'Brain death'}, {'cui': 'C0029206', 'cui_str': 'Organ donor'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0029206', 'cui_str': 'Organ donor'}, {'cui': 'C0440790', 'cui_str': 'Solid organ'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0006110', 'cui_str': 'Brain death'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}]",,0.111504,"The DONORS study is a multicentre, cluster-randomised controlled trial with a 1:1 allocation ratio designed to compare an intervention group (goal-directed checklist for brain-dead potential organ donor management) with a control group (standard ICU care).","[{'ForeName': 'Natalia Elis', 'Initials': 'NE', 'LastName': 'Giordani', 'Affiliation': 'Research Projects Office, Hospital Moinhos de Vento (HMV), Rua Ramiro Barcelos, 910, Porto Alegre, RS, 90035-001, Brazil. natigiordani@gmail.com.'}, {'ForeName': 'Caroline Cabral', 'Initials': 'CC', 'LastName': 'Robinson', 'Affiliation': 'Research Projects Office, Hospital Moinhos de Vento (HMV), Rua Ramiro Barcelos, 910, Porto Alegre, RS, 90035-001, Brazil.'}, {'ForeName': 'Glauco Adrieno', 'Initials': 'GA', 'LastName': 'Westphal', 'Affiliation': 'Research Projects Office, Hospital Moinhos de Vento (HMV), Rua Ramiro Barcelos, 910, Porto Alegre, RS, 90035-001, Brazil.'}, {'ForeName': 'Regis Goulart', 'Initials': 'RG', 'LastName': 'Rosa', 'Affiliation': 'Adult Intensive Care Unit, HMV, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Sganzerla', 'Affiliation': 'Research Projects Office, Hospital Moinhos de Vento (HMV), Rua Ramiro Barcelos, 910, Porto Alegre, RS, 90035-001, Brazil.'}, {'ForeName': 'Alexandre Biasi', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'Research Institute, Hospital do Coração (HCor), São Paulo, SP, Brazil.'}, {'ForeName': 'Flávia Ribeiro', 'Initials': 'FR', 'LastName': 'Machado', 'Affiliation': 'Department of Anaesthesiology, Pain and Intensive Care, Universidade Federal de São Paulo (UNIFESP), São Paulo, SP, Brazil.'}, {'ForeName': 'Luciano Cesar Pontes', 'Initials': 'LCP', 'LastName': 'Azevedo', 'Affiliation': 'Intensive Care Unit, Hospital Sírio-Libanês, São Paulo, SP, Brazil.'}, {'ForeName': 'Fernando Augusto', 'Initials': 'FA', 'LastName': 'Bozza', 'Affiliation': ""Department of Critical Care and Postgraduate Programme in Translational Medicine, D'Or Institute for Research and Education, Rio de Janeiro, RJ, Brazil.""}, {'ForeName': 'Cassiano', 'Initials': 'C', 'LastName': 'Teixeira', 'Affiliation': 'Department of Internal Medicine and Postgraduate Programme in Rehabilitation Science, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'de Andrade', 'Affiliation': 'Organ Procurement Organisation of Santa Catarina (OPO/SC), Florianópolis, SC, Brazil.'}, {'ForeName': 'Cristiano Augusto', 'Initials': 'CA', 'LastName': 'Franke', 'Affiliation': 'Adult Intensive Care Unit, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Cátia Moreira', 'Initials': 'CM', 'LastName': 'Guterres', 'Affiliation': 'Research Projects Office, Hospital Moinhos de Vento (HMV), Rua Ramiro Barcelos, 910, Porto Alegre, RS, 90035-001, Brazil.'}, {'ForeName': 'Itiana Cardoso', 'Initials': 'IC', 'LastName': 'Madalena', 'Affiliation': 'Research Projects Office, Hospital Moinhos de Vento (HMV), Rua Ramiro Barcelos, 910, Porto Alegre, RS, 90035-001, Brazil.'}, {'ForeName': 'Adriane Isabel', 'Initials': 'AI', 'LastName': 'Rohden', 'Affiliation': 'Research Projects Office, Hospital Moinhos de Vento (HMV), Rua Ramiro Barcelos, 910, Porto Alegre, RS, 90035-001, Brazil.'}, {'ForeName': 'Sabrina Souza', 'Initials': 'SS', 'LastName': 'da Silva', 'Affiliation': 'Research Projects Office, Hospital Moinhos de Vento (HMV), Rua Ramiro Barcelos, 910, Porto Alegre, RS, 90035-001, Brazil.'}, {'ForeName': 'Luiza Vitelo', 'Initials': 'LV', 'LastName': 'Andrighetto', 'Affiliation': 'Research Projects Office, Hospital Moinhos de Vento (HMV), Rua Ramiro Barcelos, 910, Porto Alegre, RS, 90035-001, Brazil.'}, {'ForeName': 'Gabriela Soares', 'Initials': 'GS', 'LastName': 'Rech', 'Affiliation': 'Research Projects Office, Hospital Moinhos de Vento (HMV), Rua Ramiro Barcelos, 910, Porto Alegre, RS, 90035-001, Brazil.'}, {'ForeName': 'Bruna Dos Passos', 'Initials': 'BDP', 'LastName': 'Gimenes', 'Affiliation': 'Research Projects Office, Hospital Moinhos de Vento (HMV), Rua Ramiro Barcelos, 910, Porto Alegre, RS, 90035-001, Brazil.'}, {'ForeName': 'Luciano Serpa', 'Initials': 'LS', 'LastName': 'Hammes', 'Affiliation': 'Office of the Superintendent, HMV, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Daniela Ferreira Salomão', 'Initials': 'DFS', 'LastName': 'Pontes', 'Affiliation': 'General Coordination Office of the National Transplant System, Ministério da Saúde, Brasília, DF, Brazil.'}, {'ForeName': 'Maureen O', 'Initials': 'MO', 'LastName': 'Meade', 'Affiliation': 'Department of Medicine and Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Maicon', 'Initials': 'M', 'LastName': 'Falavigna', 'Affiliation': 'Research Projects Office, Hospital Moinhos de Vento (HMV), Rua Ramiro Barcelos, 910, Porto Alegre, RS, 90035-001, Brazil.'}]",Trials,['10.1186/s13063-020-04457-1']
2794,32553881,Efficacy and safety of weekly rifapentine and isoniazid for tuberculosis prevention in Chinese silicosis patients: a randomized controlled trial.,"OBJECTIVES


To evaluate the efficacy, safety and completion rate of three-month, once-weekly rifapentine and isoniazid for tuberculosis (TB) prevention among Chinese silicosis patients.
METHODS


Male silicosis patients without human immunodeficiency virus infection, aged 18 years to 65 years, with or without latent TB infection, were randomized 1:1 to receive rifapentine/isoniazid under direct observation (3RPT/INH group) or were untreated (observation group). Active TB incidence was compared between the two groups with 37 months follow-up. Safety profile and complete rates were evaluated.
RESULTS


A total of 1,227 adults with silicosis were screened; 513 eligible participants were enrolled and assigned to 3RPT/INH (n=254) vs observation (n=259). Twenty-eight participants were diagnosed with active TB, 9 and 19 in the 3RPT/INH group and observation groups, respectively. In the intention-to-treat analysis, the cumulative active TB rate was 3.5% (9/254) in the 3RPT/INH group and 7.3% (19/259) in the observation group (log rank P=0.055). On per-protocol analysis, the cumulative active TB rates were 0.7% (1/139) and 7.3% (19/259), respectively (log rank P=0.01). Due to an unexpected high frequency of adverse events (70.4%) and Grade 3 or 4 adverse events (7.9%), the completion rate of the 3RPT/INH regimen was 54.7% (139/254). Twenty-six (10.8%) participants had flu-like systemic drug reactions; five (2.1%) experienced hepatotoxicity.
CONCLUSION


Weekly rifapentine/isoniazid prophylaxis prevented active TB among Chinese people with silicosis when taken, irrespective of LTBI screening; efficacy was reduced by lack of compliance. The regimen must be used with caution because of the high rates of adverse effects.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov number: NCT02430259.",2020,"Twenty-six (10.8%) participants had flu-like systemic drug reactions; five (2.1%) experienced hepatotoxicity.
","['Chinese silicosis patients', 'Twenty-eight participants were diagnosed with active TB, 9 and 19 in the 3RPT/INH group and observation groups, respectively', 'Male silicosis patients without human immunodeficiency virus infection, aged 18\xa0years to 65\xa0years, with or without latent TB infection', 'n=254) vs observation (n=259', '1,227 adults with silicosis were screened; 513 eligible participants']","['3RPT/INH', 'rifapentine/isoniazid under direct observation (3RPT/INH group) or were untreated (observation group', 'rifapentine and isoniazid', 'rifapentine/isoniazid prophylaxis']","['Active TB incidence', 'completion rate', 'Safety profile and complete rates', 'Efficacy and safety', 'efficacy, safety and completion rate', 'flu-like systemic drug reactions', 'cumulative active TB rate', 'adverse events', 'cumulative active TB rates', 'active TB', 'hepatotoxicity']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0037116', 'cui_str': 'Pneumoconiosis due to silica'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1609538', 'cui_str': 'Inactive tuberculosis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0073372', 'cui_str': 'rifapentine'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}]",1227.0,0.444171,"Twenty-six (10.8%) participants had flu-like systemic drug reactions; five (2.1%) experienced hepatotoxicity.
","[{'ForeName': 'Qiao-Ling', 'Initials': 'QL', 'LastName': 'Ruan', 'Affiliation': 'Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai 200040, China; National Clinical Research Center for Aging and Medicine, Huashan Hospital, Fudan University, Shanghai 200040, China.'}, {'ForeName': 'Xi-Tian', 'Initials': 'XT', 'LastName': 'Huang', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Qing-Luan', 'Initials': 'QL', 'LastName': 'Yang', 'Affiliation': 'Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai 200040, China.'}, {'ForeName': 'Xue-Feng', 'Initials': 'XF', 'LastName': 'Liu', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai 200040, China; National Clinical Research Center for Aging and Medicine, Huashan Hospital, Fudan University, Shanghai 200040, China.'}, {'ForeName': 'Ke-Chuan', 'Initials': 'KC', 'LastName': 'Pan', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Yao-Jie', 'Initials': 'YJ', 'LastName': 'Shen', 'Affiliation': 'Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai 200040, China; State Key Laboratory of Genetic Engineering, School of Life Science, Fudan University, Shanghai 200438, China.'}, {'ForeName': 'Li-Min', 'Initials': 'LM', 'LastName': 'Cai', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Ling', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Jiang', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Jin-Jing', 'Initials': 'JJ', 'LastName': 'Hong', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Xiao-Dan', 'Initials': 'XD', 'LastName': 'Wang', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Chun-Lian', 'Initials': 'CL', 'LastName': 'Ma', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Guan-Qing', 'Initials': 'GQ', 'LastName': 'Peng', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Xiu-Zhen', 'Initials': 'XZ', 'LastName': 'Wang', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Jin-Chao', 'Initials': 'JC', 'LastName': 'Mao', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Tian-Zhou', 'Initials': 'TZ', 'LastName': 'Wu', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Miao-Yao', 'Initials': 'MY', 'LastName': 'Lin', 'Affiliation': ""The First People's Hospital of Wengling, Zhejiang, China.""}, {'ForeName': 'Ling-Yun', 'Initials': 'LY', 'LastName': 'Shao', 'Affiliation': 'Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai 200040, China; National Clinical Research Center for Aging and Medicine, Huashan Hospital, Fudan University, Shanghai 200040, China. Electronic address: lingyun26@fudan.edu.cn.'}, {'ForeName': 'Wen-Hong', 'Initials': 'WH', 'LastName': 'Zhang', 'Affiliation': 'Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai 200040, China; National Clinical Research Center for Aging and Medicine, Huashan Hospital, Fudan University, Shanghai 200040, China; Key Laboratory of Medical Molecular Virology (MOE/MOH) and Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, Shanghai 200032, China; State Key Laboratory of Genetic Engineering, School of Life Science, Fudan University, Shanghai 200438, China. Electronic address: zhangwenhong@fudan.edu.cn.'}]",Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,['10.1016/j.cmi.2020.06.008']
2795,32553888,Effect of practical hyperoxic high-intensity interval training on exercise performance.,"This study investigated the effect of a practical hyperoxic high-intensity interval training (HIIT) on aerobic and anaerobic exercise capacity. Sixteen male athletes were randomized into 2 groups: normoxic HIIT (NHIIT, n = 8) group or hyperoxic HIIT (HHIIT, n = 8) group and trained for 3 weeks (2 days/week) on a cycle ergometer (2-min intervals, with 2-min rest between intervals) at maximal workload, which was obtained during a maximal graded exercise test under normoxia. All training sessions were performed until exhaustion. Participants performed maximal graded exercise, submaximal exercise, and 90-s maximal exercise tests before and after the training period. Maximal oxygen uptake (P <  0.01) increased significantly in both groups. Blood lactate curve during submaximal exercise improved significantly only in the HHIIT group (P <  0.01). Mean power output during maximal exercise increased significantly only in the HHIIT group (P =  0.02). This study demonstrated that a practical hyperoxic HHIIT might be effective for improving aerobic capacity and anaerobic performance.",2020,Blood lactate curve during submaximal exercise improved significantly only in the HHIIT group (P <  0.01).,['Sixteen male athletes'],"['normoxic HIIT (NHIIT, n\u2009=\u20098) group or hyperoxic HIIT (HHIIT, n\u2009=\u20098) group and trained for 3 weeks (2 days/week) on a cycle ergometer (2-min intervals, with 2-min rest between intervals) at maximal workload, which was obtained during a maximal graded exercise test under normoxia', 'maximal graded exercise, submaximal exercise, and 90-s maximal exercise tests', 'practical hyperoxic high-intensity interval training', 'practical hyperoxic high-intensity interval training (HIIT']","['Mean power output during maximal exercise', 'Blood lactate curve during submaximal exercise', 'Maximal oxygen uptake', 'aerobic capacity and anaerobic performance', 'aerobic and anaerobic exercise capacity', 'exercise performance']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0677547', 'cui_str': 'days/week'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",16.0,0.0253253,Blood lactate curve during submaximal exercise improved significantly only in the HHIIT group (P <  0.01).,"[{'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Kon', 'Affiliation': 'School of International Liberal Studies, Chukyo University, 101-2 Yagotohonmachi, Showa-ku, Nagoya, 466-8666, Japan; Department of Sports Sciences, Japan Institute of Sports Sciences, 3-15-1 Nishigaoka, Kita-ku, Tokyo, 115-0056, Japan. Electronic address: kon.michihiro@gmail.com.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Nakagaki', 'Affiliation': 'Department of Sports Sciences, Japan Institute of Sports Sciences, 3-15-1 Nishigaoka, Kita-ku, Tokyo, 115-0056, Japan; Department of Sports Sciences, Yamanashi Gakuin University, 2-4-5 Sakaori, Kofu, Yamanashi, 400-8575, Japan.'}, {'ForeName': 'Yoshiko', 'Initials': 'Y', 'LastName': 'Ebi', 'Affiliation': 'Department of Sports Sciences, Japan Institute of Sports Sciences, 3-15-1 Nishigaoka, Kita-ku, Tokyo, 115-0056, Japan.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103481']
2796,32553922,Conditioning Automatic Inhibition Task: Introducing a Novel Task to Associate Automatic Inhibition with Specific Cues.,"There is growing interest in methods for conditioning automatic inhibition with specific stimuli and the potential clinical implications of these methods. For example, OCD patients were shown to benefit from a computerized training program which aimed to create an association between OCD-related cues and stopping behaviors. In the current study, we aimed to investigate the ability to condition inhibition to specific stimuli and whether such conditioning can be generalized between tasks to last over time. Participants completed 6 training sessions using a novel version of the stop-signal task, the 'conditioning automatic inhibition task' (CAIT), over a 48 -h period, in which one randomly chosen color patch was associated with inhibition. The classic Stroop task was administered before and after the CAIT training. Results yielded smaller congruency and interference effects in the Stroop task after training, but only for the color that was associated with stopping. These results demonstrate the effect of the CAIT onto one specific stimulus, and that the effect generalized between the training and testing tasks. This provides novel evidence that the CAIT can be used to facilitate faster recruitment of inhibitory resources for a specific trained stimulus, which might later help resolve cognitive conflicts that require inhibition and might also have important clinical implications.",2020,"Results yielded smaller congruency and interference effects in the Stroop task after training, but only for the color that was associated with stopping.",[],"['Conditioning Automatic Inhibition Task', ""training sessions using a novel version of the stop-signal task, the 'conditioning automatic inhibition task' (CAIT""]",['smaller congruency and interference effects'],[],"[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",1.0,0.0185002,"Results yielded smaller congruency and interference effects in the Stroop task after training, but only for the color that was associated with stopping.","[{'ForeName': 'Shachar', 'Initials': 'S', 'LastName': 'Hochman', 'Affiliation': 'Department of Psychology and the Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Department of Psychology, The Hebrew University of Jerusalem, Israel. Electronic address: shacharh@post.bgu.ac.il.'}, {'ForeName': 'Shahaf', 'Initials': 'S', 'LastName': 'Leshem', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Israel.'}, {'ForeName': 'Avishai', 'Initials': 'A', 'LastName': 'Henik', 'Affiliation': 'Department of Psychology and the Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Kalanthroff', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Israel.'}]",Journal of neuroscience methods,['10.1016/j.jneumeth.2020.108809']
2797,32553932,The Second Strategic Reperfusion Early After Myocardial Infarction (STREAM-2) study optimizing pharmacoinvasive reperfusion strategy in older ST-elevation myocardial infarction patients.,"BACKGROUND


The STREAM study demonstrated that a pharmaco-invasive strategy was at least as effective as primary PCI (pPCI) in patients presenting early with ST-elevation myocardial infarction (STEMI). The current trial is a response to the finding that reduced intracranial hemorrhage (ICH) in patients ≥75 years occurred after halving the dose of tenecteplase. Additionally, a subsequent analysis of full dose tenecteplase or alteplase in the Assessment of the Safety and Efficacy of a New Thrombolytic (ASSENT) trials demonstrated a steep increase in bleeding events beginning around the age of 60 years.
METHODS


STREAM-2 will compare the efficacy and safety of a novel pharmaco-invasive strategy as compared to routine pPCI in STEMI patients ≥60 years presenting within 3 hours from symptom onset. In the pharmaco-invasive arm patients will receive half-dose tenecteplase, as soon as possible before transport to a PCI center. In the pPCI arm, patients will be treated according to optimal standard of care defined by local practice. The key criteria for efficacy will be the number of patients achieving ≥50% ST-segment resolution before and after PCI in lead with maximal ST elevation at baseline and the clinical endpoints of death, congestive heart failure, shock or re-infarction, rescue PCI and aborted myocardial infarction, both singularly and as a composite at 30 days. Key safety criteria are total stroke, ICH and major non-intracranial bleeds. Approximately 600 patients will be randomized (400 to pharmaco-invasive treatment and 200 to pPCI). An interim analysis is planned after 300 patients are enrolled to consider adapting the trial to include a larger sample size aimed at undertaking a formal confirmatory trial.
DISCUSSION


The study will provide new insights aimed at establishing an effective and safer pharmaco-invasive treatment for the growing population of older STEMI patients who cannot undergo timely pPCI.",2020,The current trial is a response to the finding that reduced intracranial hemorrhage (ICH) in patients ≥75 years occurred after halving the dose of tenecteplase.,"['older STEMI patients who cannot undergo timely pPCI', '300 patients', 'older ST-elevation myocardial infarction patients', 'Approximately 600 patients', 'STEMI patients ≥60 years presenting within 3 hours from symptom onset', 'patients presenting early with ST-elevation myocardial infarction (STEMI']",['novel pharmaco-invasive strategy'],"['intracranial hemorrhage (ICH', 'bleeding events', 'efficacy and safety']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}]","[{'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",600.0,0.0767294,The current trial is a response to the finding that reduced intracranial hemorrhage (ICH) in patients ≥75 years occurred after halving the dose of tenecteplase.,"[{'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Armstrong', 'Affiliation': 'The Canadian Virtual Coordinating Centre for Global Collaborative Cardiovascular Research {Canadian VIGOUR Centre}, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Bogaerts', 'Affiliation': 'Interuniversity Institute for Biostatistics and statistical Bioinformatics (I-BioStat), KU Leuven, Leuven and University Hasselt, Hasselt, Belgium.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Welsh', 'Affiliation': 'The Canadian Virtual Coordinating Centre for Global Collaborative Cardiovascular Research {Canadian VIGOUR Centre}, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Sinnaeve', 'Affiliation': 'Dept. of Cardiovascular Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Goldstein', 'Affiliation': 'Emergency Department and SAMU, Lille University Hospital, Lille, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Pages', 'Affiliation': 'Boehringer Ingelheim GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Danays', 'Affiliation': 'TDC, Aix en Provence, France.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Van de Werf', 'Affiliation': 'Dept. of Cardiovascular Sciences, KU Leuven, Leuven, Belgium. Electronic address: frans.vandewerf@kuleuven.be.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.04.029']
2798,32554072,Downregulating the P2 × 3 Receptor in the Carotid Body to Reduce Blood Pressure via Acoustic Gene Delivery in Canines.,"The purinergic P2 × 3 receptor in the carotid body (CB) is considered a new target for treating hypertension, although approaches for targeted regulating P2 × 3 receptor expression are lacking. Here, we explored the feasibility of targeted P2 × 3 receptor down-regulation in CBs by localized low-intensity focused ultrasound (LIFU)-mediated gene delivery to reduce the blood pressure. Thirty-two Kunming canines were randomly assigned to the treatment group (n = 14), negative control group (n = 10), LIFU + cationic microbubbles group (n = 4), and LIFU-only group (n = 4). Plasmid-loaded cationic microbubbles were injected and bilateral CBs were irradiated with a LIFU-based transducer. Flow cytometry showed that 33.15% of transfected cells expressed the green fluorescent protein reporter gene. T7 endonuclease I assays showed an insertion-deletion rate of 8.30%. The P2 × 3 receptor mRNA- and protein-expression levels in CBs decreased by 56.31% and 45.10%, respectively, in the treatment group. Mean systolic (152.5 ± 3.0 versus 138.0 ± 2.9 mm Hg, P=0.003) and diastolic (97.8 ± 1.5 versus 87.2 ± 2.3 mm Hg, p= 0.002) blood pressures reduced on day 14 in the treatment group, compared with the baseline values, whereas no effects were observed with LIFU treatment or cationic microbubbles injection alone. Canines treated with this strategy exhibited no local or systemic adverse events. Thus, LIFU-mediated gene delivery to CBs successfully modulated CB function and reduced blood pressure in a canine model, suggesting a new possibility for treating hypertension and further clinical translation.",2020,"The P2 × 3 receptor mRNA- and protein-expression levels in CBs decreased by 56.31% and 45.10%, respectively, in the treatment group.",['Thirty-two Kunming canines'],"['negative control group (n\u202f=\u202f10), LIFU\u202f+\u202fcationic microbubbles group (n\u202f=\u202f4), and LIFU-only group']","['insertion-deletion rate', 'blood pressure', 'Mean systolic', 'local or systemic adverse events', 'blood pressures', 'protein-expression levels in CBs']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1258018', 'cui_str': 'Microbubbles'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1956002', 'cui_str': 'Insertion-Deletion Mutation'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0504845,"The P2 × 3 receptor mRNA- and protein-expression levels in CBs decreased by 56.31% and 45.10%, respectively, in the treatment group.","[{'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Xue', 'Affiliation': 'Department of Cardiology, the Second Affiliated Hospital of Chongqing Medical University.'}, {'ForeName': 'Ruiyu', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, the Second Affiliated Hospital of Chongqing Medical University.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, the Second Affiliated Hospital of Chongqing Medical University.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xiong', 'Affiliation': 'Department of Cardiology, the Second Affiliated Hospital of Chongqing Medical University.'}, {'ForeName': 'Lingjiao', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, the Second Affiliated Hospital of Chongqing Medical University.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Qian', 'Affiliation': 'Department of Cardiology, the Second Affiliated Hospital of Chongqing Medical University.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Hao', 'Affiliation': 'Chongqing Key Laboratory of Ultrasound Molecular Imaging, Chongqing Medical University.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Chongqing Key Laboratory of Ultrasound Molecular Imaging, Chongqing Medical University.'}, {'ForeName': 'Dichuan', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, the Second Affiliated Hospital of Chongqing Medical University.'}, {'ForeName': 'Changming', 'Initials': 'C', 'LastName': 'Deng', 'Affiliation': 'Department of Cardiology, the Second Affiliated Hospital of Chongqing Medical University.'}, {'ForeName': 'Shunkang', 'Initials': 'S', 'LastName': 'Rong', 'Affiliation': 'Department of Cardiology, the Second Affiliated Hospital of Chongqing Medical University.'}, {'ForeName': 'Yuanqing', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Department of Cardiology, the Second Affiliated Hospital of Chongqing Medical University.'}, {'ForeName': 'Yonghong', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, the Second Affiliated Hospital of Chongqing Medical University.'}, {'ForeName': 'Que', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': 'Department of Cardiology, the Second Affiliated Hospital of Chongqing Medical University.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiology, the Second Affiliated Hospital of Chongqing Medical University; Institute of Ultrasound Imaging, Department of Ultrasound, the Second Affiliated Hospital of Chongqing Medical University. Electronic address: huangjing@cqmu.edu.cn.'}]",Translational research : the journal of laboratory and clinical medicine,['10.1016/j.trsl.2020.06.005']
2799,32554105,Cost-effectiveness of a collaborative care program for managing major depression and chronic musculoskeletal pain in primary care: Economic evaluation alongside a randomized controlled trial.,"BACKGROUND


We designed a collaborative care program for the integrated management of chronic musculoskeletal pain and depression, which frequently coexist in primary care patients. The aim of this study was to evaluate the cost-effectiveness of this program compared with care as usual.
METHODS


We performed a cost-effectiveness analysis alongside a randomized clinical trial. Results were monitored over a 12-month period. The primary outcome was the incremental cost-effectiveness ratio (ICER). We performed cost-effectiveness analyses from the perspectives of the healthcare system and society using an intention-to-treat approach with imputation of missing values.
RESULTS


We evaluated 328 patients (167 in the intervention group and 161 in the control group) with chronic musculoskeletal pain and major depression at baseline. From the healthcare system perspective, the mean incremental cost was €234 (p = .17) and the mean incremental effectiveness was 0.009 QALYs (p = .66), resulting in an ICER of €23,989/QALY. Costs from the societal perspective were €235 (p = .16), yielding an ICER of €24,102/QALY. These estimates were associated with a high degree of uncertainty illustrated on the cost-effectiveness plane.
CONCLUSIONS


Contrary to our expectations, the collaborative care program had no significant effects on health status, and although the additional costs of implementing the program compared with care as usual were not high, we were unable to demonstrate a favorable cost-effectiveness ratio, largely due to the high degree of uncertainty surrounding the estimates.",2020,"Costs from the societal perspective were €235 (p = .16), yielding an ICER of €24,102/QALY.","['328 patients (167 in the intervention group and 161 in the control group) with chronic musculoskeletal pain and major depression at baseline', 'primary care patients', 'managing major depression and chronic musculoskeletal pain in primary care']",['collaborative care program'],"['Cost-effectiveness', 'mean incremental effectiveness', 'mean incremental cost', 'health status', 'cost-effectiveness', 'incremental cost-effectiveness ratio (ICER']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",328.0,0.0923458,"Costs from the societal perspective were €235 (p = .16), yielding an ICER of €24,102/QALY.","[{'ForeName': 'Enric', 'Initials': 'E', 'LastName': 'Aragonès', 'Affiliation': ""Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain; Atenció Primària Camp de Tarragona, Institut Català de la Salut, Tarragona, Spain. Electronic address: earagones.tgn.ics@gencat.cat.""}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Sánchez-Iriso', 'Affiliation': 'Department of Economics, Public University of Navarra, Pamplona, Spain; Instituto de Investigación Sanitaria de Navarra (IdiSNA), Pamplona, Spain.'}, {'ForeName': 'Germán', 'Initials': 'G', 'LastName': 'López-Cortacans', 'Affiliation': ""Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain; Atenció Primària Camp de Tarragona, Institut Català de la Salut, Tarragona, Spain.""}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Tomé-Pires', 'Affiliation': ""Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain; ISCTE-Lisbon University Institute (ISCTE-IUL), Center for Social Research and Intervention (CIS-IUL), Lisbon, Portugal.""}, {'ForeName': 'Concepción', 'Initials': 'C', 'LastName': 'Rambla', 'Affiliation': ""Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain; Atenció Primària Camp de Tarragona, Institut Català de la Salut, Tarragona, Spain.""}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Sánchez-Rodríguez', 'Affiliation': ""Unit for the Study and Treatment of Pain - ALGOS, Research Center for Behavior Assessment (CRAMC), Department of Psychology, Universitat Rovira i Virgili, Tarragona, Spain; Institut d'Investigació Sanitària Pere Virgili, Universitat Rovira i Virgili, Tarragona, Spain.""}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110167']
2800,32552850,Intense and unpredictable perturbations during gait training improve dynamic balance abilities in chronic hemiparetic individuals: a randomized controlled pilot trial.,"BACKGROUND


Previous studies have assessed the effects of perturbation training on balance after stroke. However, the perturbations were either applied while standing or were small in amplitude during gait, which is not representative of the most common fall conditions. The perturbations were also combined with other challenges such as progressive increases in treadmill speed.
OBJECTIVE


To determine the benefit of treadmill training with intense and unpredictable perturbations compared to treadmill walking-only training for dynamic balance and gait post-stroke.
METHODS


Twenty-one individuals post-stroke with reduced dynamic balance abilities, with or without a history of fall and ability to walk on a treadmill without external support or a walking aid for at least 1 min were allocated to either an unpredictable gait perturbation (Perturb) group or a walking-only (NonPerturb) group through covariate adaptive randomization. Nine training sessions were conducted over 3 weeks. NonPerturb participants only walked on the treadmill but were offered perturbation training after the control intervention. Pre- and post-training evaluations included balance and gait abilities, maximal knee strength, balance confidence and community integration. Six-week phone follow-ups were conducted for balance confidence and community integration. Satisfaction with perturbation training was also assessed.
RESULTS


With no baseline differences between groups (p > 0.075), perturbation training yielded large improvements in most variables in the Perturb (p < 0.05, Effect Size: ES > .46) group (n = 10) and the NonPerturb (p ≤ .089, ES > .45) group (n = 7 post-crossing), except for maximal strength (p > .23) in the NonPerturb group. Walking-only training in the NonPerturb group (n = 8, pre-crossing) mostly had no effect (p > .292, ES < .26), except on balance confidence (p = .063, ES = .46). The effects of the gait training were still present on balance confidence and community integration at follow-up. Satisfaction with the training program was high.
CONCLUSION


Intense and unpredictable gait perturbations have the potential to be an efficient component of training to improve balance abilities and community integration in individuals with chronic stroke. Retrospective registration: ClinicalTrials.gov. March 18th, 2020. Identifier: NCT04314830.",2020,", perturbation training yielded large improvements in most variables in the Perturb (p < 0.05, Effect Size: ES > .46) group (n = 10) and the NonPerturb (p ≤ .089, ES > .45) group (n = 7 post-crossing), except for maximal strength (p > .23) in the NonPerturb group.","['Twenty-one individuals post-stroke with reduced dynamic balance abilities, with or without a history of fall and ability to walk on a treadmill without external support or a walking aid for at least 1\u2009min', 'chronic hemiparetic individuals', 'individuals with chronic stroke']","['gait training', 'treadmill training with intense and unpredictable perturbations compared to treadmill walking-only training', 'unpredictable gait perturbation (Perturb) group or a walking-only (NonPerturb) group through covariate adaptive randomization', 'perturbation training']","['balance and gait abilities, maximal knee strength, balance confidence and community integration', 'dynamic balance abilities', 'balance confidence', 'maximal strength', 'progressive increases in treadmill speed', 'balance confidence and community integration']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C1561668', 'cui_str': 'History of fall'}, {'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]","[{'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C3494302', 'cui_str': 'Community Integration'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]",,0.0445433,", perturbation training yielded large improvements in most variables in the Perturb (p < 0.05, Effect Size: ES > .46) group (n = 10) and the NonPerturb (p ≤ .089, ES > .45) group (n = 7 post-crossing), except for maximal strength (p > .23) in the NonPerturb group.","[{'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Esmaeili', 'Affiliation': 'School of Rehabilitation, Université de Montréal, P.O. Box 6128, Station Centre-Ville, Montreal, Quebec, H3C 3J7, Canada.'}, {'ForeName': 'Andréanne', 'Initials': 'A', 'LastName': 'Juneau', 'Affiliation': ""Centre for Interdisciplinary Research in Rehabilitation-Institut Universitaire sur la Réadaptation en Déficience Physique de Montréal, in CIUSSS du Centre-Sud-de-l'ile-de-Montréal, Montreal, Canada.""}, {'ForeName': 'Joseph-Omer', 'Initials': 'JO', 'LastName': 'Dyer', 'Affiliation': 'School of Rehabilitation, Université de Montréal, P.O. Box 6128, Station Centre-Ville, Montreal, Quebec, H3C 3J7, Canada.'}, {'ForeName': 'Anouk', 'Initials': 'A', 'LastName': 'Lamontagne', 'Affiliation': ""Centre for Interdisciplinary Research in Rehabilitation-Institut Universitaire sur la Réadaptation en Déficience Physique de Montréal, in CIUSSS du Centre-Sud-de-l'ile-de-Montréal, Montreal, Canada.""}, {'ForeName': 'Dahlia', 'Initials': 'D', 'LastName': 'Kairy', 'Affiliation': 'School of Rehabilitation, Université de Montréal, P.O. Box 6128, Station Centre-Ville, Montreal, Quebec, H3C 3J7, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bouyer', 'Affiliation': 'Department of Rehabilitation, Faculty of Medicine, Université Laval and Center for Interdisciplinary Research in Rehabilitation and Social Integration, CIUSSS-CN, Quebec City, Canada.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Duclos', 'Affiliation': 'School of Rehabilitation, Université de Montréal, P.O. Box 6128, Station Centre-Ville, Montreal, Quebec, H3C 3J7, Canada. cyril.duclos@umontreal.ca.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00707-0']
2801,32552857,"The OPTIMIZE patient- and family-centered, primary care-based deprescribing intervention for older adults with dementia or mild cognitive impairment and multiple chronic conditions: study protocol for a pragmatic cluster randomized controlled trial.","BACKGROUND


Most individuals with dementia or mild cognitive impairment (MCI) have multiple chronic conditions (MCC). The combination leads to multiple medications and complex medication regimens and is associated with increased risk for significant treatment burden, adverse drug events, cognitive changes, hospitalization, and mortality. Optimizing medications through deprescribing (the process of reducing or stopping the use of inappropriate medications or medications unlikely to be beneficial) may improve outcomes for MCC patients with dementia or MCI.
METHODS


With input from patients, family members, and clinicians, we developed and piloted a patient-centered, pragmatic intervention (OPTIMIZE) to educate and activate patients, family members, and primary care clinicians about deprescribing as part of optimal medication management for older adults with dementia or MCI and MCC. The clinic-based intervention targets patients on 5 or more medications, their family members, and their primary care clinicians using a pragmatic, cluster-randomized design at Kaiser Permanente Colorado. The intervention has two components: a patient/ family component focused on education and activation about the potential value of deprescribing, and a clinician component focused on increasing clinician awareness about options and processes for deprescribing. Primary outcomes are total number of chronic medications and total number of potentially inappropriate medications (PIMs). We estimate that approximately 2400 patients across 9 clinics will receive the intervention. A comparable number of patients from 9 other clinics will serve as wait-list controls. We have > 80% power to detect an average decrease of - 0.70 (< 1 medication). Secondary outcomes include the number of PIM starts, dose reductions for selected PIMs (benzodiazepines, opiates, and antipsychotics), rates of adverse drug events (falls, hemorrhagic events, and hypoglycemic events), ability to perform activities of daily living, and skilled nursing facility, hospital, and emergency department admissions.
DISCUSSION


The OPTIMIZE trial will examine whether a primary care-based, patient- and family-centered intervention educating patients, family members, and clinicians about deprescribing reduces numbers of chronic medications and PIMs for older adults with dementia or MCI and MCC.
TRIAL REGISTRATION


NCT03984396. Registered on 13 June 2019.",2020,"The combination leads to multiple medications and complex medication regimens and is associated with increased risk for significant treatment burden, adverse drug events, cognitive changes, hospitalization, and mortality.","['approximately 2400 patients across 9 clinics will receive the intervention', 'older adults with dementia or mild cognitive impairment and multiple chronic conditions', 'individuals with dementia or mild cognitive impairment (MCI) have multiple chronic conditions (MCC', 'MCC patients with dementia or MCI', 'With input from patients, family members, and clinicians', 'The clinic-based intervention targets patients on 5 or more medications, their family members, and their primary care clinicians using a pragmatic, cluster-randomized design at Kaiser Permanente Colorado', 'older adults with dementia or MCI and MCC']","['primary care clinicians about deprescribing as part of optimal medication management', 'primary care-based deprescribing intervention']","['adverse drug events, cognitive changes, hospitalization, and mortality', 'number of PIM starts, dose reductions for selected PIMs (benzodiazepines, opiates, and antipsychotics), rates of adverse drug events (falls, hemorrhagic events, and hypoglycemic events), ability to perform activities of daily living, and skilled nursing facility, hospital, and emergency department admissions', 'total number of chronic medications and total number of potentially inappropriate medications (PIMs']","[{'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4517656', 'cui_str': '2400'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C3266262', 'cui_str': 'Multiple chronic diseases'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}]","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0037265', 'cui_str': 'Skilled nursing facility'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",,0.0361616,"The combination leads to multiple medications and complex medication regimens and is associated with increased risk for significant treatment burden, adverse drug events, cognitive changes, hospitalization, and mortality.","[{'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Bayliss', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA. Elizabeth.Bayliss@kp.org.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Shetterly', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Drace', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Norton', 'Affiliation': 'Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Green', 'Affiliation': 'Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Reeve', 'Affiliation': 'Quality Use of Medicines and Pharmacy Research Centre, UniSA: Clinical and Health Sciences, University of South Australia, Adelaide, SA, Australia.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Weffald', 'Affiliation': 'Department of Clinical Pharmacy, Kaiser Permanente Colorado, Aurora, CO, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Wright', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Maciejewski', 'Affiliation': 'Durham Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham, Veterans Affairs Medical Center, Durham, NC, USA.'}, {'ForeName': 'O C', 'Initials': 'OC', 'LastName': 'Sheehan', 'Affiliation': 'Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Wolff', 'Affiliation': 'School of Public Health, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'K S', 'Initials': 'KS', 'LastName': 'Gleason', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kraus', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Maiyani', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Du Vall', 'Affiliation': 'Department of Clinical Pharmacy, Kaiser Permanente Colorado, Aurora, CO, USA.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Boyd', 'Affiliation': 'Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}]",Trials,['10.1186/s13063-020-04482-0']
2802,32552943,[Efficacy of Small Dose HAG Regimen Combined with Decitabine in Treatment of Elderly Patients with Acute Myeloid Leukemia].,"OBJECTIVE


To study the efficacy of small dose HAG combined with decitabine regimen in the treatment of elderly patients with acute myeloid leukemia (AML).
METHODS


134 elderly AML patients treated in our hospital from March 2015 to December 2018 were selected, and the patients were divided into CAG group and combined treatment group. The AML patients in CAG group was treated with CAG regimen, while the AML patients in combined treatment group was treated with small dose HAG regimen combined with decitabine. Efficacy was evaluated after treatment.
RESULTS


After treatment, the OR rate of the patients in combined treatment group was significantly higher than that in CAG group (χ 2 =5.311, P=0.021). The nausea and vomiting rate, infection rate, myelosuppression rate, bleeding rate and intestinal discomfort rate showed no significant difference between the two groups (P＞0.05). The CD3 + , CD4 +  and CD8 +  levels of patients in combined treatment group were significantly lower than those in CAG group (P＜0.05). The result of followed-up for 2 years, showed that the overall survival rate of patients in combined treatment group was significantly higher than that in CAG group [(76.2±6.3)% vs (45.7±7.6)%] (χ 2 =4.214, P＜0.05), while the disease free survival rate of patients in combined treatment group were (57.4±7.7)%, which was significantly higher than that in CAG group (30.3±7.9)% (χ 2 =5.250, P＜0.05).
CONCLUSION


Small dose HAG regimen combined with decitabine for elderly patients with acute myeloid leukemia has a certain curative efficacy.",2020,"The nausea and vomiting rate, infection rate, myelosuppression rate, bleeding rate and intestinal discomfort rate showed no significant difference between the two groups (P＞0.05).","['134 elderly AML patients treated in our hospital from March 2015 to December 2018', 'Elderly Patients with Acute Myeloid Leukemia', 'elderly patients with acute myeloid leukemia', 'elderly patients with acute myeloid leukemia (AML']","['decitabine', 'CAG', 'HAG combined with decitabine regimen', 'Small Dose HAG Regimen Combined with Decitabine']","['OR rate', 'CD3 + , CD4 +  and CD8 +  levels', 'disease free survival rate', 'overall survival rate', 'Efficacy', 'nausea and vomiting rate, infection rate, myelosuppression rate, bleeding rate and intestinal discomfort rate']","[{'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0049065', 'cui_str': 'decitabine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",134.0,0.0202826,"The nausea and vomiting rate, infection rate, myelosuppression rate, bleeding rate and intestinal discomfort rate showed no significant difference between the two groups (P＞0.05).","[{'ForeName': 'Peng-Ji', 'Initials': 'PJ', 'LastName': 'Pan', 'Affiliation': 'Department of Hematology, Yongchuan Hospital of Chongqing Medical University, Chongqing 402160, China.'}, {'ForeName': 'Zhang-Qin', 'Initials': 'ZQ', 'LastName': 'Luo', 'Affiliation': 'Department of Hematology, Yongchuan Hospital of Chongqing Medical University, Chongqing 402160, China,E-mail: luozq056@126.com.'}]",Zhongguo shi yan xue ye xue za zhi,['10.19746/j.cnki.issn.1009-2137.2020.03.018']
2803,32553151,"Novel antisense inhibition of diacylglycerol O-acyltransferase 2 for treatment of non-alcoholic fatty liver disease: a multicentre, double-blind, randomised, placebo-controlled phase 2 trial.","BACKGROUND


Diacylglycerol-O-acyltransferase 2 (DGAT2) is one of two enzyme isoforms that catalyse the final step in the synthesis of triglycerides. IONIS-DGAT2 Rx  is an antisense oligonucleotide inhibitor of DGAT2 that is under clinical investigation for the treatment of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). The aim of this trial was to examine the safety, tolerability, and efficacy of IONIS-DGAT2 Rx  versus placebo in reducing liver fat in patients with type 2 diabetes and NAFLD.
METHODS


This double-blind, randomised, placebo-controlled, phase 2 study consisted of a 2-week screening period, a run-in period of up to 4 weeks, a 13-week treatment period of once-weekly dosing, and a 13-week post-treatment follow-up period. The study was done at 16 clinical research sites in Canada, Poland, and Hungary. Eligible participants were aged 18-75 years, had a body-mass index at screening between 27 kg/m 2  and 39 kg/m 2 , haemoglobin A 1c  (HbA 1c ) levels from 7·3% to 9·5%, and liver fat content 10% or greater before randomisation, and agreed to maintain a stable diet and exercise routine throughout the study. Enrolled participants were stratified on the basis of liver fat content during the run-in period (<20% or ≥20%) and then centrally randomised (2:1) to receive once weekly subcutaneous injection of 250 mg IONIS-DGAT2 Rx  or placebo for 13 weeks. Participants, investigators, funder personnel, and the clinical research organisation staff, including central readers of MRI scans, were all masked to treatment identity. The primary endpoints were the safety, tolerability, and pharmacodynamic effect of IONIS-DGAT2 Rx  on hepatic steatosis, according to absolute reduction from baseline in liver fat percentage as quantified by MRI-estimated proton density fat fraction and assessed in the per-protocol population. Pharmacodynamic performance was determined in the per-protocol population by the change in liver fat content from baseline to 2 weeks after the last dose. The per-protocol population included all randomised participants who received at least ten doses of study drug, with the first four doses administered in the first 5 weeks, did not miss more than three consecutive weekly doses, and who had no protocol deviations that might affect efficacy. All randomised participants who received at least one dose of study drug were included in the safety analysis. This study is registered with ClinicalTrials.gov, NCT03334214.
FINDINGS


Between Nov 3, 2017, and Nov 28, 2018, we screened 173 people for eligibility. 44 were enrolled and randomly assigned to receive either IONIS-DGAT2 Rx  (29 participants) or placebo (15 participants). After 13 weeks of treatment, the mean absolute reduction from baseline was -5·2% (SD 5·4) in the IONIS-DGAT2 Rx  group compared with -0·6% (6·1) in the placebo group (treatment difference -4·2%, 95% CI -7·8 to -0·5, p=0·026). Reductions in liver fat were not accompanied by hyperlipidaemia, elevations in serum aminotransferases or plasma glucose, changes in bodyweight, or gastrointestinal side-effects compared with placebo. Six serious adverse events occurred in four patients treated with IONIS-DGAT2 Rx . No serious adverse events were reported in the placebo group. One of four patients reported three serious adverse events: acute exacerbation of chronic obstructive pulmonary disease, cardiac arrest, and ischaemic cerebral infarction, each considered severe and not related to study drug. Three of four patients reported one serious adverse event of increased blood triglycerides (severe, unrelated to study drug), deep-vein thrombosis (severe, unlikely to be related to study drug), and acute pancreatitis (mild, unrelated to study drug).
INTERPRETATION


Our results suggest that DGAT2 antisense inhibition could be a safe and efficacious strategy for treatment of NAFLD and support further investigation in patients with biopsy-proven NASH. Based on the pharmacological target, the response to treatment observed in this study population could extend to the broader population of patients with NAFLD.
FUNDING


Ionis Pharmaceuticals.",2020,"Reductions in liver fat were not accompanied by hyperlipidaemia, elevations in serum aminotransferases or plasma glucose, changes in bodyweight, or gastrointestinal side-effects compared with placebo.","['Between Nov 3, 2017, and Nov 28, 2018', '16 clinical research sites in Canada, Poland, and Hungary', 'non-alcoholic fatty liver disease', 'patients with biopsy-proven NASH', 'Eligible participants were aged 18-75 years, had a body-mass index at screening between 27 kg/m 2  and 39 kg/m 2 , haemoglobin A 1c  (HbA 1c ) levels from 7·3% to 9·5%, and liver fat content 10% or greater before randomisation, and agreed to maintain a stable diet and exercise routine throughout the study', '173 people for eligibility', 'patients with type 2 diabetes and NAFLD']","['IONIS-DGAT2', 'subcutaneous injection of 250 mg IONIS-DGAT2', 'diacylglycerol O-acyltransferase', 'Rx  versus placebo', 'placebo']","['liver fat', 'Six serious adverse events', 'Pharmacodynamic performance', 'safety, tolerability, and pharmacodynamic effect of IONIS-DGAT2', 'serious adverse events', 'safety, tolerability, and efficacy', 'blood triglycerides (severe, unrelated to study drug), deep-vein thrombosis (severe', 'serum aminotransferases or plasma glucose, changes in bodyweight, or gastrointestinal side-effects', 'serious adverse events: acute exacerbation of chronic obstructive pulmonary disease, cardiac arrest, and ischaemic cerebral infarction']","[{'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0032356', 'cui_str': 'Poland'}, {'cui': 'C0020174', 'cui_str': 'Hungary'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0163260', 'cui_str': 'Diacylglycerol acyltransferase'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0163260', 'cui_str': 'Diacylglycerol acyltransferase'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0518018', 'cui_str': 'Blood triglycerides'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0445356', 'cui_str': 'Unrelated'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C1262005', 'cui_str': 'Ischaemic cerebral infarction'}]",44.0,0.583485,"Reductions in liver fat were not accompanied by hyperlipidaemia, elevations in serum aminotransferases or plasma glucose, changes in bodyweight, or gastrointestinal side-effects compared with placebo.","[{'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Loomba', 'Affiliation': 'NAFLD Research Center, Division of Gastroenterology, University of California at San Diego, La Jolla, CA, USA. Electronic address: roloomba@ucsd.edu.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Morgan', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, CA, USA.'}, {'ForeName': 'Lynnetta', 'Initials': 'L', 'LastName': 'Watts', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, CA, USA.'}, {'ForeName': 'Shuting', 'Initials': 'S', 'LastName': 'Xia', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, CA, USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Hannan', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, CA, USA.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Geary', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, CA, USA.'}, {'ForeName': 'Brenda F', 'Initials': 'BF', 'LastName': 'Baker', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, CA, USA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Bhanot', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, CA, USA.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(20)30186-2']
2804,32553191,"Aqueous olanexidine versus aqueous povidone-iodine for surgical skin antisepsis on the incidence of surgical site infections after clean-contaminated surgery: a multicentre, prospective, blinded-endpoint, randomised controlled trial.","BACKGROUND


Surgical site infection (SSI) is the most common problem after surgery. Although several guidelines have indicated the efficacy of antiseptics, such as chlorhexidine-alcohol and povidone-iodine, in reducing SSI rate, the optimal recommendation is still not established. Olanexidine might have higher bactericidal activity than other antiseptic agents. However, no randomised study has evaluated the efficacy and safety of olanexidine over conventional antiseptics. We compared the effect of aqueous olanexidine and aqueous povidone-iodine on the incidence of SSI following clean-contaminated surgery.
METHODS


This was a multicentre, prospective, randomised, blinded-endpoint superiority trial for surgical skin antisepsis in clean-contaminated gastrointestinal and hepatobiliary pancreatic surgeries in four Japanese hospitals. Patients aged 20 years or older who underwent elective clean-contaminated wound surgery were randomly assigned in a 1:1 replacement ratio using a computer-generated block randomisation. Patients were randomly assigned to surgical skin antisepsis with an aqueous formulation of 1·5% olanexidine or surgical skin antisepsis with an aqueous formulation of 10% povidone-iodine before surgery. We used olanexidine in a ready-to-use applicator, and povidone-iodine was administered by a brush or by compression using pliers. Both antiseptics were applied from the papilla with a cranial limit and to the upper thigh with a caudal limit. The antiseptics were allowed to dry for 3 min, and then surgery started. Participants, some investigators, and data analysts were masked to treatment allocation. Participant enrolment was done by non-masked investigators. The primary outcome was 30-day SSI assessed in the intention-to-treat population. The surgical wound site of each participant was observed daily. After discharge, participants underwent at least one outpatient visit within 30 days after surgery. This trial is registered with University hospital Medical Information Network, 000031560.
FINDINGS


Between June 10, 2018, and April 18, 2019, 883 patients were assessed for eligibility. 587 patients were eligible and 294 received olanexidine and 293 received aqueous povidone-iodine before surgery. 30-day SSI occurred in 19 (7%) patients in the olanexidine group and 39 patients (13%) patients in the povidone-iodine group (adjusted risk difference -0·069; 90% CI -0·109 to -0·029; adjusted risk ratio [RR] 0·48, 90% CI 0·30 to 0·74; p=0·002). Five patients (2%) in the olanexidine group and five (2%) in the povidone-iodine group developed adverse skin reactions (adjusted RR 0·99, 95% CI 0·29 to 3·40; p=1·00).
INTERPRETATION


Olanexidine significantly reduced the occurrence of overall SSI and superficial incisional SSI compared with aqueous povidone-iodine in clean-contaminated surgery. Our results indicate that olanexidine might have a role to prevent SSI in patients who undergo clean-contaminated surgeries.
FUNDING


Keio University and Ohyama Health Foundation.",2020,"INTERPRETATION


Olanexidine significantly reduced the occurrence of overall SSI and superficial incisional SSI compared with aqueous povidone-iodine in clean-contaminated surgery.","['Patients aged 20 years or older who underwent elective clean-contaminated wound surgery', 'Between June 10, 2018, and April 18, 2019', 'patients who undergo clean-contaminated surgeries', '587 patients were eligible and 294 received', 'clean-contaminated gastrointestinal and hepatobiliary pancreatic surgeries in four Japanese hospitals', 'surgical site infections after clean-contaminated surgery', '0·48', '883 patients were assessed for eligibility']","['surgical skin antisepsis with an aqueous formulation of 1·5% olanexidine or surgical skin antisepsis with an aqueous formulation of 10% povidone-iodine before surgery', 'olanexidine and 293 received aqueous povidone-iodine before surgery', 'chlorhexidine-alcohol and povidone-iodine', 'aqueous olanexidine and aqueous povidone-iodine', 'Olanexidine', 'olanexidine', 'Aqueous olanexidine versus aqueous povidone-iodine', 'povidone-iodine', 'surgical skin antisepsis', 'aqueous povidone-iodine']","['SSI rate', 'adverse skin reactions', '30-day SSI assessed in the intention-to-treat population', 'bactericidal activity', 'efficacy and safety', '30-day SSI', 'occurrence of overall SSI and superficial incisional SSI', 'risk ratio [RR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0205279', 'cui_str': 'Contaminated'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0003424', 'cui_str': 'Antisepsis'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0755906', 'cui_str': 'olanexidine'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0544570', 'cui_str': 'Bactericidal activity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3662309', 'cui_str': 'Superficial incisional surgical site infection'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",883.0,0.17549,"INTERPRETATION


Olanexidine significantly reduced the occurrence of overall SSI and superficial incisional SSI compared with aqueous povidone-iodine in clean-contaminated surgery.","[{'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Obara', 'Affiliation': 'Department of Surgery, Keio University School of Medicine, Tokyo, Japan. Electronic address: obara.z3@keio.jp.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Takeuchi', 'Affiliation': 'Department of Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Kawakubo', 'Affiliation': 'Department of Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Shinoda', 'Affiliation': 'Department of Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Okabayashi', 'Affiliation': 'Department of Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Koki', 'Initials': 'K', 'LastName': 'Hayashi', 'Affiliation': 'Department of Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yasuhito', 'Initials': 'Y', 'LastName': 'Sekimoto', 'Affiliation': 'Department of Surgery, National Hospital Organization Tokyo Medical Center, Tokyo, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Maeda', 'Affiliation': 'Department of Surgery, Tokyo Saiseikai Central Hospital, Tokyo, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Kondo', 'Affiliation': 'Department of Surgery, Kawasaki Municipal Hospital, Kanagawa, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Department of Preventive Medicine and Public Health, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Kitagawa', 'Affiliation': 'Department of Surgery, Keio University School of Medicine, Tokyo, Japan.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30225-5']
2805,32553252,Subclinical Leaflet Thrombosis in Transcatheter and Surgical Bioprosthetic Valves: PARTNER 3 Cardiac Computed Tomography Substudy.,"BACKGROUND


Subclinical leaflet thrombosis, characterized by hypoattenuated leaflet thickening (HALT) and reduced leaflet motion observed on 4-dimensional computed tomography (CT), may represent a form of bioprosthetic valve dysfunction.
OBJECTIVES


The U.S. Food and Drug Administration mandated CT studies to understand the natural history of this finding, differences between transcatheter and surgical valves, and its association with valve hemodynamics and clinical outcomes.
METHODS


The PARTNER 3 (The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low-Risk Patients With Aortic Stenosis) CT substudy randomized 435 patients with low-surgical-risk aortic stenosis to undergo transcatheter aortic valve replacement (n = 221) or surgery (n = 214). Serial 4-dimensional CTs were performed at 30 days and 1 year and were analyzed independently by a core laboratory.
RESULTS


The incidence of HALT increased from 10% at 30 days to 24% at 1 year. Spontaneous resolution of 30-day HALT occurred in 54% of patients at 1 year, whereas new HALT appeared in 21% of patients at 1 year. HALT was more frequent in transcatheter versus surgical valves at 30 days (13% vs. 5%; p = 0.03), but not at 1 year (28% vs. 20%; p = 0.19). The presence of HALT did not significantly affect aortic valve mean gradients at 30 days or 1 year. Patients with HALT at both 30 days and 1 year, compared with those with no HALT at 30 days and 1 year, had significantly increased aortic valve gradients at 1 year (17.8 ± 2.2 mm Hg vs. 12.7. ± 0.3 mm Hg; p = 0.04).
CONCLUSIONS


Subclinical leaflet thrombosis was more frequent in transcatheter compared with surgical valves at 30 days, but not at 1 year. The impact of HALT on thromboembolic complications and structural valve degeneration needs further assessment.",2020,"HALT was more frequent in transcatheter versus surgical valves at 30 days (13% vs. 5%; p = 0.03), but not at 1 year (28% vs. 20%; p = 0.19).","['435 patients with low-surgical-risk aortic stenosis to undergo transcatheter aortic valve replacement (n\xa0=\xa0221) or surgery (n\xa0=\xa0214', 'Low-Risk Patients With Aortic Stenosis']","['Transcatheter and Surgical Bioprosthetic\xa0Valves', '4-dimensional computed tomography (CT', 'HALT']","['aortic valve gradients', 'incidence of HALT', 'Spontaneous resolution of 30-day HALT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}]","[{'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0205400', 'cui_str': 'Thickened'}]","[{'cui': 'C0428905', 'cui_str': 'Aortic valve ventriculoarterial gradient'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205400', 'cui_str': 'Thickened'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",435.0,0.0726715,"HALT was more frequent in transcatheter versus surgical valves at 30 days (13% vs. 5%; p = 0.03), but not at 1 year (28% vs. 20%; p = 0.19).","[{'ForeName': 'Raj R', 'Initials': 'RR', 'LastName': 'Makkar', 'Affiliation': 'Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California. Electronic address: Raj.Makkar@cshs.org.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Blanke', 'Affiliation': ""St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Jonathon', 'Initials': 'J', 'LastName': 'Leipsic', 'Affiliation': ""St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Vinod', 'Initials': 'V', 'LastName': 'Thourani', 'Affiliation': 'Piedmont Heart Institute, Atlanta, Georgia.'}, {'ForeName': 'Tarun', 'Initials': 'T', 'LastName': 'Chakravarty', 'Affiliation': 'Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Brown', 'Affiliation': 'Baylor Scott and White Healthcare, Plano, Texas.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Trento', 'Affiliation': 'Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Guyton', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'Vasilis', 'Initials': 'V', 'LastName': 'Babaliaros', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'New York University Langone Medical Center, New York, New York.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Jilaihawi', 'Affiliation': 'New York University Langone Medical Center, New York, New York.'}, {'ForeName': 'Susheel', 'Initials': 'S', 'LastName': 'Kodali', 'Affiliation': 'Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New York.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'George', 'Affiliation': 'Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New York.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lu', 'Affiliation': 'Department of Biostatistics, Edwards Lifesciences, Irvine, California.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'McCabe', 'Affiliation': 'University of Washington, Seattle, Washington.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Friedman', 'Affiliation': 'Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Smalling', 'Affiliation': 'The University of Texas Health Science Center at Houston, Houston, Texas.'}, {'ForeName': 'Shing Chiu', 'Initials': 'SC', 'LastName': 'Wong', 'Affiliation': 'Cornell University New York, New York, New York.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Yazdani', 'Affiliation': 'Inova Heart and Vascular Institute (Fairfax Inova), Falls Church, Virginia.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Bax', 'Affiliation': 'Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Kapadia', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Howard C', 'Initials': 'HC', 'LastName': 'Herrmann', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mack', 'Affiliation': 'Baylor Scott and White Healthcare, Plano, Texas.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Leon', 'Affiliation': 'Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New York.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.04.043']
2806,32553417,Postoperative Pain after Treatment Using the GentleWave System: A Randomized Controlled Trial.,"INTRODUCTION


Cleaning and shaping are necessary to allow for the delivery of irrigants and medicaments to the apical third of the canal. Standard treatment irrigation generally uses a conventional needle and some frequency of sonic activation. The GentleWave System (GWS; Sonendo, Inc, Laguna Hills, CA) combines irrigant delivery with multisonic activation. This randomized clinical trial aimed to determine if the GWS significantly decreases the incidence and intensity of postoperative pain.
METHODS


Patients used a numeric rating scale to record their pain level at the 6-hour time point before treatment. All participants were randomly divided into 2 groups and were blind to the treatment they received. The standard (control) group received endodontic treatment with conventional side-vented needle irrigation and ultrasonic activation. The second group received treatment with the GWS. Following treatment, patients used a numeric rating scale to record their pain level at 6, 24, 72, and 168 hours.
RESULTS


In the standard treatment group, 72.2% of patients experienced at least 1 occurrence of postoperative pain, whereas in the GWS group, 83.3% of patients experienced at least 1 occurrence of postoperative pain. The highest pain intensity level for both treatments occurred at the 6-hour posttreatment time point. All pain decreased with time after the 6-hour posttreatment time point (P < 1.237e -7 ).
CONCLUSIONS


There was no significant difference in the incidence or intensity of postoperative pain after either treatment group. However, both groups reported a statistically significant decrease in pain with time.",2020,"All pain decreased with time after the 6-hour posttreatment time point (P < 1.237e -7 ).
",[],"['GWS', 'GentleWave System', 'endodontic treatment with conventional side-vented needle irrigation and ultrasonic activation']","['All pain', 'postoperative pain', 'pain with time', 'highest pain intensity level', 'Postoperative Pain', 'incidence or intensity of postoperative pain', 'numeric rating scale to record their pain level']",[],"[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0700632', 'cui_str': 'Endodontic procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0181988', 'cui_str': 'Medication transfer needle, vented'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0332311', 'cui_str': 'With time'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",,0.0471475,"All pain decreased with time after the 6-hour posttreatment time point (P < 1.237e -7 ).
","[{'ForeName': 'Daryl', 'Initials': 'D', 'LastName': 'Grigsby', 'Affiliation': 'Division of Endodontics, School of Dentistry, University of Minnesota, Minneapolis, Minnesota. Electronic address: grigs029@umn.edu.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Ordinola-Zapata', 'Affiliation': 'Division of Endodontics, School of Dentistry, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Scott B', 'Initials': 'SB', 'LastName': 'McClanahan', 'Affiliation': 'Division of Endodontics, School of Dentistry, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Fok', 'Affiliation': 'Minnesota Dental Research Center for Biomaterials and Biomechanics, School of Dentistry, University of Minnesota, Minneapolis, Minnesota.'}]",Journal of endodontics,['10.1016/j.joen.2020.04.004']
2807,32553428,Relationship of visceral adiposity index with new-onset proteinuria in hypertensive patients.,"BACKGROUND & AIMS


Visceral adiposity index (VAI) is a sex-specific surrogate marker of adipose tissue distribution and function. Little is known about the longitudinal relationship between VAI and proteinuria. This study aimed to examine the prospective relationship of baseline VAI with new-onset of proteinuria in hypertensive patients without major cardiovascular diseases.
METHODS


A total of 10 699 hypertensive patients without proteinuria (negative urine dipstick reading) at baseline from the renal sub-study of the China Stroke Primary Prevention Trial (CSPPT) were included. Participants were randomly assigned to a double-blind daily treatment with 10 mg enalapril and 0.8 mg folic acid or 10 mg enalapril alone. Participants were followed every 3 months after randomization. The primary outcome was new-onset proteinuria, defined as a urine dipstick reading of ≥1+ at the exit visit. The secondary outcome was progression of proteinuria, defined as a urine dipstick reading of trace or ≥1+ at the exit visit.
RESULTS


During a median follow-up duration of 4.4 years, a total of 396 (3.7%) participants developed new-onset proteinuria, while 1236 (11.6%) participants met progression of proteinuria. When VAI was categorized into quartiles, compared with participants in quartile 1-3 (<2.99), a significantly higher risk of new-onset proteinuria (OR, 1.43; 95%CI: 1.07-1.91) and progression of proteinuria (OR, 1.23; 95%CI: 1.03-1.46) was found in those in quartile 4 (≥2.99). Moreover, the positive association was consistent in participants with or without general obesity, abdominal obesity, and dyslipidemia (all P-interactions > 0.05).
CONCLUSIONS


There was a positive association between VAI levels and the risk of new-onset proteinuria in hypertensive patients.",2020,There was a positive association between VAI levels and the risk of new-onset proteinuria in hypertensive patients.,"['hypertensive patients', 'A total of 10\xa0699 hypertensive patients without proteinuria (negative urine dipstick reading) at baseline from the renal sub-study of the China Stroke Primary Prevention Trial (CSPPT) were included', 'hypertensive patients without major cardiovascular diseases']",['enalapril and 0.8\xa0mg folic acid or 10\xa0mg enalapril alone'],"['visceral adiposity index', 'progression of proteinuria, defined as a urine dipstick reading of trace or ≥1+ at the exit visit', 'new-onset proteinuria, defined as a urine dipstick reading of ≥1+ at the exit visit', 'general obesity, abdominal obesity, and dyslipidemia', 'risk of new-onset proteinuria', 'VAI levels', 'new-onset proteinuria', 'progression of proteinuria']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0441090', 'cui_str': 'Dipstick'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0033144', 'cui_str': 'Primary prevention'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}]","[{'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0441090', 'cui_str': 'Dipstick'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0442822', 'cui_str': 'Trace'}, {'cui': 'C0337094', 'cui_str': 'Exit'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",10699.0,0.175487,There was a positive association between VAI levels and the risk of new-onset proteinuria in hypertensive patients.,"[{'ForeName': 'Mengyi', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'National Clinical Research Center for Kidney Disease, State Key Laboratory for Organ Failure Research, Division of Nephrology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.'}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'National Clinical Research Center for Kidney Disease, State Key Laboratory for Organ Failure Research, Division of Nephrology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.'}, {'ForeName': 'Zhuxian', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'National Clinical Research Center for Kidney Disease, State Key Laboratory for Organ Failure Research, Division of Nephrology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.'}, {'ForeName': 'Panpan', 'Initials': 'P', 'LastName': 'He', 'Affiliation': 'National Clinical Research Center for Kidney Disease, State Key Laboratory for Organ Failure Research, Division of Nephrology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'National Clinical Research Center for Kidney Disease, State Key Laboratory for Organ Failure Research, Division of Nephrology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Xie', 'Affiliation': 'National Clinical Research Center for Kidney Disease, State Key Laboratory for Organ Failure Research, Division of Nephrology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Nie', 'Affiliation': 'National Clinical Research Center for Kidney Disease, State Key Laboratory for Organ Failure Research, Division of Nephrology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Liang', 'Affiliation': 'National Clinical Research Center for Kidney Disease, State Key Laboratory for Organ Failure Research, Division of Nephrology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Beijing Advanced Innovation Center for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, 100083, China.'}, {'ForeName': 'Chengzhang', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Shenzhen Evergreen Medical Institute, Shenzhen, 518057, China.'}, {'ForeName': 'Lishun', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Beijing Advanced Innovation Center for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, 100083, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huo', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Binyan', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Shenzhen Evergreen Medical Institute, Shenzhen, 518057, China; Institute of Biomedicine, Anhui Medical University, Hefei, 230032, China.'}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Population, Family and Reproductive Health, Johns Hopkins University Bloomberg School of Public Health, 615 N. Wolfe Street, E4132, Baltimore, MD, 21205-2179, USA.'}, {'ForeName': 'Xiping', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'National Clinical Research Center for Kidney Disease, State Key Laboratory for Organ Failure Research, Division of Nephrology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China; Beijing Advanced Innovation Center for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, 100083, China. Electronic address: xipingxu126@126.com.'}, {'ForeName': 'Xianhui', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'National Clinical Research Center for Kidney Disease, State Key Laboratory for Organ Failure Research, Division of Nephrology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China. Electronic address: pharmaqin@126.com.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.05.031']
2808,32553435,"Effectiveness of radial extracorporeal shock-wave therapy versus ultrasound-guided low-dose intra-articular steroid injection in improving shoulder pain, function, and range of motion in diabetic patients with shoulder adhesive capsulitis.","To compare the efficacy of radial extracorporeal shock-wave therapy (rESWT) vs. an ultrasound-guided low-dose intra-articular steroid injection in pain reduction and functional improvement in diabetic patients with shoulder adhesive capsulitis (AC).
METHODS


This was a 2-parallel-group, active-control, assessor-blinded, randomized trial. We randomized 103 diabetic patients with shoulder AC to receive either 4 sessions of rESWT, 1 week apart (rESWT group, n = 52), or a single ultrasound-guided low-dose intra-articular steroid injection of 20 mg of triamcinolone acetonide (steroid group, n = 51). The primary outcome measure was functional improvement evaluated by the Quick Disabilities of the Arm, Shoulder and Hand (qDASH) score. Secondary outcome measures were pain evaluated by the visual analog scale score and shoulder range of motion (ROM). An assessor who was blinded to treatment assignment assessed both groups at baseline and at 4, 8, and 12 weeks thereafter.
RESULTS


By 12 weeks, both groups demonstrated a significant reduction in the qDASH score and pain severity, as well as improvement in ROM. However, significantly improved function (qDASH score, 40.4 ± 12.9 vs. 50.5 ± 13.3; P < .001) and shoulder pain reduction (visual analog scale score, 1.6 ± 1.2 vs. 2.8 ± 1.7; P < .001) were found in the rESWT group vs. the steroid group. Similar improvement in shoulder ROM was observed in both groups.
CONCLUSION


At short-term follow-up, rESWT was superior to a low-dose intra-articular steroid injection in improving function and pain in diabetic patients with shoulder AC. Therefore, rESWT might be considered a safe alternative to steroid injections in diabetic patients with shoulder AC.",2020,"At short-term follow-up, rESWT was superior to a low-dose intra-articular steroid injection in improving function and pain in diabetic patients with shoulder AC.","['diabetic patients with shoulder adhesive capsulitis (AC', 'diabetic patients with shoulder adhesive capsulitis', 'diabetic patients with shoulder AC', '103 diabetic patients with shoulder AC']","['radial extracorporeal shock-wave therapy versus ultrasound-guided low-dose intra-articular steroid injection', 'radial extracorporeal shock-wave therapy (rESWT) vs. an ultrasound-guided low-dose intra-articular steroid injection', 'single ultrasound-guided low-dose intra-articular steroid injection of 20 mg of triamcinolone acetonide (steroid']","['ROM', 'qDASH score and pain severity', 'shoulder pain, function, and range of motion', 'shoulder ROM', 'function (qDASH score', 'pain evaluated by the visual analog\xa0scale score and shoulder range of motion (ROM', 'shoulder pain reduction (visual analog scale score', 'pain reduction and functional improvement', 'function and pain', 'functional improvement evaluated by the Quick Disabilities of the Arm, Shoulder and Hand (qDASH) score']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0311223', 'cui_str': 'Adhesive capsulitis of shoulder'}, {'cui': 'C0158300', 'cui_str': 'Capsulitis, Adhesive'}, {'cui': 'C4517526', 'cui_str': '103'}]","[{'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}]","[{'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0575545', 'cui_str': 'Shoulder joint - range of movement'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",103.0,0.0648429,"At short-term follow-up, rESWT was superior to a low-dose intra-articular steroid injection in improving function and pain in diabetic patients with shoulder AC.","[{'ForeName': 'Tasneem El Desouky Mohammed', 'Initials': 'TEDM', 'LastName': 'El Naggar', 'Affiliation': 'Department of Physical Medicine, Rheumatology and Rehabilitation, Faculty of Medicine, Suez Canal University, Ismailia, Egypt.'}, {'ForeName': 'Ahmed Ibrahim Elsayed', 'Initials': 'AIE', 'LastName': 'Maaty', 'Affiliation': 'Department of Physical Medicine, Rheumatology and Rehabilitation, Faculty of Medicine, Suez Canal University, Ismailia, Egypt.'}, {'ForeName': 'Aly Elsayed', 'Initials': 'AE', 'LastName': 'Mohamed', 'Affiliation': 'Department of Physical Medicine, Rheumatology and Rehabilitation, Faculty of Medicine, Suez Canal University, Ismailia, Egypt. Electronic address: Ali_elsayed@med.suez.edu.eg.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2020.03.005']
2809,32553436,"Effect of cocktail therapy after arthroscopic rotator cuff repair: a randomized, double-blind trial.","BACKGROUND


We investigated the effectiveness of cocktail therapy after arthroscopic rotator cuff repair (ARCR).
METHODS


We evaluated 128 shoulders undergoing ARCR and used block randomization to divide patients into 2 groups in this double-blind trial: The cocktail group received 20 mL of 0.75% ropivacaine, 5 mg of morphine, 0.3 mg of epinephrine, 2 mg of betamethasone, and saline solution to a total of 42 mL, whereas the control group received 20 mL of 0.75% ropivacaine and saline solution to a total of 42 mL. Postoperatively, one of the drug mixtures was injected into the glenohumeral joint, subacromial bursa, suprascapular nerve, and anterior, middle, and posterior parts of the deltoid muscle according to the treatment group. We recorded patients' visual analog scale scores preoperatively and at 4, 8, 16, 24, and 48 hours postoperatively; the number of patients using postoperative diclofenac suppositories and buprenorphine hydrochloride; the number of patients experiencing nausea; the number of patients with infection and delayed wound healing as adverse effects; the surgery time; the retear rate; and passive shoulder range of motion.
RESULTS


The cocktail group constituted 64 shoulders (50.0%), with 39 men (60.9%) and 25 women (39.1%); the mean age was 64.2 ± 10.2 years. The control group constituted 64 shoulders (50.0%), with 41 men (64.1%) and 23 women (35.9%); the mean age was 65.2 ± 7.5 years. We found no significant difference in age or sex between the 2 groups. There was also no significant difference in rotator cuff tear size or surgery time between the 2 groups. The visual analog scale scores at 8, 16, and 24 hours postoperatively were significantly lower in the cocktail group. The number of patients using suppositories was also significantly lower in the cocktail group. The number of patients receiving buprenorphine injections tended to be lower in the cocktail group, but the difference was not significant. Nausea occurred in 6.3% of patients in the cocktail group and 15.6% in the control group, but the difference was not significant. No infection or delayed wound healing occurred in either group. There was no significant difference in the retear rate between the 2 groups. Passive anterior elevation at 3 months postoperatively was significantly better in the cocktail group than in the control group.
CONCLUSION


We compared cocktail therapy and ropivacaine after ARCR and found no difference in results except for VAS score at 8, 16, and 24 hours postoperatively and frequency of postoperative suppository use without an apparent risk of infection or a detrimental effect on tendon healing.",2020,"Passive anterior elevation at 3 months postoperatively was significantly better in the cocktail group than in the control group.
","['64 shoulders (50.0%), with 39 men (60.9%)\xa0and 25 women (39.1%); the mean age was 64.2 ± 10.2 years', '64 shoulders (50.0%), with 41 men (64.1%) and 23 women (35.9%); the mean age was 65.2 ± 7.5 years', 'arthroscopic rotator cuff repair', '128 shoulders undergoing ARCR and used block randomization to divide patients into 2 groups']","['diclofenac suppositories', 'cocktail therapy', 'control group received 20 mL of 0.75% ropivacaine and saline solution', 'ropivacaine', 'buprenorphine', 'cocktail group received 20 mL of 0.75% ropivacaine, 5 mg of morphine, 0.3 mg of epinephrine, 2 mg of betamethasone, and saline solution', 'buprenorphine hydrochloride']","['tendon healing', 'rotator cuff tear size or surgery time', 'VAS score', 'Nausea', 'retear rate', 'Passive anterior elevation', 'visual analog scale scores', 'No infection or delayed wound healing', 'number of patients experiencing nausea; the number of patients with infection and delayed wound healing as adverse effects; the surgery time; the retear rate; and passive shoulder range of motion']","[{'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}, {'cui': 'C0678420', 'cui_str': 'Cocktail'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C0701445', 'cui_str': 'Buprenorphine hydrochloride'}]","[{'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0263912', 'cui_str': 'Rotator cuff syndrome'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C2712105', 'cui_str': 'Absence of signs and symptoms of infection'}, {'cui': 'C0151692', 'cui_str': 'Impaired wound healing'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0575545', 'cui_str': 'Shoulder joint - range of movement'}]",128.0,0.0445013,"Passive anterior elevation at 3 months postoperatively was significantly better in the cocktail group than in the control group.
","[{'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Teratani', 'Affiliation': 'Ouryouji Orthopaedic Hospital, Kobayashi, Japan. Electronic address: jordan200618@yahoo.co.jp.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2020.03.004']
2810,32553596,Analysis of the COMPARE-AMI trial: First report of long-term safety of CD133+ cells.,"BACKGROUND


Data related to long-term safety of intracoronary (IC) injection of CD133+ bone marrow stem cells (BMSC) following an acute myocardial infarction (MI) are still lacking.
METHODS


COMPARE-AMI is a double-blind, placebo-controlled phase II clinical trial evaluating the safety and efficacy of IC injection of CD133+ enriched hematopoietic BMSC in patients with ST-elevation myocardial infarction (STEMI) and persistent left ventricular (LV) dysfunction following successful primary percutaneous coronary intervention (PCI). Herein, we report outcomes up to ten years of follow-up.
RESULTS


Between November 2007 and July 2012, we enrolled 38 patients in our study. Males were 89% and the median age was 50.5 years. Baseline left ventricular ejection fraction (LVEF) was 40.0%, and 90% of lesions were located in the left anterior descending (LAD) artery. The median follow-up time was 8.5 years IQR [7.9, 10.0]. Using Kaplan-Meier methods, MACE-free survival up to 10 years was 77.3% overall. IC injection of CD133+ BMSC was associated with a similar event-free survival rate compared to placebo (87.8% vs. 66.3%, p = .37). Two cancer cases in each group were recorded. No malignant arrhythmias were observed.
CONCLUSIONS


IC injection of CD133+ BMSC is safe up to 10 years of follow-up. The long-term efficacy needs to be confirmed by a larger randomized trial.",2020,"IC injection of CD133+ BMSC was associated with a similar event-free survival rate compared to placebo (87.8% vs. 66.3%, p = .37).","['patients with ST-elevation myocardial infarction (STEMI) and persistent left ventricular (LV) dysfunction following successful primary percutaneous coronary intervention (PCI', 'Between November 2007 and July 2012, we enrolled 38 patients in our study', 'Males were 89% and the median age was 50.5\u202fyears']","['CD133+ BMSC', 'CD133+ cells', 'CD133+ enriched hematopoietic BMSC', 'intracoronary (IC) injection of CD133+ bone marrow stem cells (BMSC', 'placebo']","['survival rate', 'Baseline left ventricular ejection fraction (LVEF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0595454', 'cui_str': 'Intracoronary route'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}]",38.0,0.324342,"IC injection of CD133+ BMSC was associated with a similar event-free survival rate compared to placebo (87.8% vs. 66.3%, p = .37).","[{'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Haddad', 'Affiliation': ""Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada; Centre Hospitalier de l'Université de Montréal (CHUM) Research Center, Montréal, Québec, Canada.""}, {'ForeName': 'Brian James', 'Initials': 'BJ', 'LastName': 'Potter', 'Affiliation': ""Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada; Centre Hospitalier de l'Université de Montréal (CHUM) Research Center, Montréal, Québec, Canada.""}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Matteau', 'Affiliation': ""Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada; Centre Hospitalier de l'Université de Montréal (CHUM) Research Center, Montréal, Québec, Canada.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Reeves', 'Affiliation': ""Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada; Centre Hospitalier de l'Université de Montréal (CHUM) Research Center, Montréal, Québec, Canada.""}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Leclerc', 'Affiliation': ""Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada; Centre Hospitalier de l'Université de Montréal (CHUM) Research Center, Montréal, Québec, Canada.""}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Rivard', 'Affiliation': ""Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada; Centre Hospitalier de l'Université de Montréal (CHUM) Research Center, Montréal, Québec, Canada.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Gobeil', 'Affiliation': ""Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada; Centre Hospitalier de l'Université de Montréal (CHUM) Research Center, Montréal, Québec, Canada.""}, {'ForeName': 'Denis-Claude', 'Initials': 'DC', 'LastName': 'Roy', 'Affiliation': 'Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada; Hôpital Maisonneuve-Rosemont, Montréal, Québec, Canada.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Noiseux', 'Affiliation': ""Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada; Centre Hospitalier de l'Université de Montréal (CHUM) Research Center, Montréal, Québec, Canada.""}, {'ForeName': 'Samer', 'Initials': 'S', 'LastName': 'Mansour', 'Affiliation': ""Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada; Centre Hospitalier de l'Université de Montréal (CHUM) Research Center, Montréal, Québec, Canada. Electronic address: samer.mansour@sympatico.ca.""}]",International journal of cardiology,['10.1016/j.ijcard.2020.06.004']
2811,32553637,Acute hemodynamics of cardiac sympathetic denervation.,"INTRODUCTION


We aimed to study the immediate hemodynamic effects of thoracoscopic bilateral cardiac sympathetic denervation (CSD) for recurrent ventricular tachycardia (VT) or VT storm.
METHOD


We studied a group of 18 adults who underwent bilateral thoracoscopic CSD; the blood pressure (BP) and Heart Rate (HR) were continuously monitored during the surgery and up to 6 h post-operatively.
RESULTS


Immediately on removal of the sympathetic ganglia, the patients had a drop in both the systolic (110 mm Hg-95.8 mm Hg, p < 0.001) and diastolic BP (69.4 mm Hg-65 mm Hg, p = 0.007) along with a drop in the HR (81.6 bpm to 61.2 bpm, p < 0.001).At 6 h after CSD, the systolic and diastolic BP did not recover significantly, while there was recovery in HR (61.2 bpm to 66 bpm, p = 0.02). There was no significant difference between those with and without left ventricular (LV) systolic dysfunction.
CONCLUSION


The acute hemodynamic changes during the perioperative period of CSD are significant but not serious. Awareness of this is useful for peri-operative management.",2020,"There was no significant difference between those with and without left ventricular (LV) systolic dysfunction.
",['18 adults who underwent'],"['bilateral thoracoscopic CSD', 'thoracoscopic bilateral cardiac sympathetic denervation (CSD']","['recovery in HR', 'systolic and diastolic BP', 'diastolic BP', 'acute hemodynamic changes', 'left ventricular (LV) systolic dysfunction', 'blood pressure (BP) and Heart Rate (HR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0039038', 'cui_str': 'Sympathectomy'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0749225', 'cui_str': 'Systolic dysfunction'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",,0.0511635,"There was no significant difference between those with and without left ventricular (LV) systolic dysfunction.
","[{'ForeName': 'Kunal', 'Initials': 'K', 'LastName': 'Sinkar', 'Affiliation': 'Holy Family Hospital, Bandra West, Mumbai, 400050, India.'}, {'ForeName': 'Avishek', 'Initials': 'A', 'LastName': 'Bagchi', 'Affiliation': 'Holy Family Hospital, Bandra West, Mumbai, 400050, India. Electronic address: avi25986@gmail.com.'}, {'ForeName': 'Ankit', 'Initials': 'A', 'LastName': 'Mahajan', 'Affiliation': 'Holy Family Hospital, Bandra West, Mumbai, 400050, India.'}, {'ForeName': 'Ramalingam', 'Initials': 'R', 'LastName': 'Vadivelu', 'Affiliation': 'Holy Family Hospital, Bandra West, Mumbai, 400050, India.'}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Venkat', 'Affiliation': 'Holy Family Hospital, Bandra West, Mumbai, 400050, India.'}, {'ForeName': 'Reshma', 'Initials': 'R', 'LastName': 'Motwani', 'Affiliation': 'Holy Family Hospital, Bandra West, Mumbai, 400050, India.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Vichare', 'Affiliation': 'Holy Family Hospital, Bandra West, Mumbai, 400050, India.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Joshi', 'Affiliation': 'Holy Family Hospital, Bandra West, Mumbai, 400050, India.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Parikh', 'Affiliation': 'Holy Family Hospital, Bandra West, Mumbai, 400050, India.'}, {'ForeName': 'Jude', 'Initials': 'J', 'LastName': 'Vaz', 'Affiliation': 'Holy Family Hospital, Bandra West, Mumbai, 400050, India.'}, {'ForeName': 'Yash', 'Initials': 'Y', 'LastName': 'Lokhandwala', 'Affiliation': 'Holy Family Hospital, Bandra West, Mumbai, 400050, India.'}]",Indian pacing and electrophysiology journal,['10.1016/j.ipej.2020.06.006']
2812,32553642,Love at first taste: Activation in reward-related brain regions during single-trial naturalistic appetitive conditioning in humans.,"Palatable food can trigger appetitive responses, such as salivation and approach tendencies. Though evolutionarily functional, these conditioned responses can encourage overeating and obesity when food is abundant. The current study examines the neural correlates of 'denovo' Pavlovian appetitive conditioning, pairing one class of unknown objects (conditioned stimuli, CS) with their sweet taste (unconditioned stimulus, US) during a single trial. To do so, 23 participants consumed unknown (marzipan) objects of one particular color (CS+) while only interacting with control stimuli of different color and shape (CS-). After this single-trial conditioning procedure, participants viewed and rated images of the marzipan figures and the control objects during functional magnetic resonance imaging (fMRI). Relative to the CS-, the CS+ elicited stronger activation in the dorsal striatum, a brain region associated with cue-reward coupling. Furthermore, conditioning effects in subjective 'craving', defined as increased palatability and desire to eat, were observed, and these were positively related to conditioning effects in the amygdala, a brain region associated with the need-dependent value of a reward. Thus, the study identified reward-related brain regions involved in single-trial appetitive learning, thereby providing a potential mechanism that contributes to the etiology of food craving. These findings might help to understand clinically relevant food cravings in individuals with eating or weight related concerns and might support the development of extinction based treatments.",2020,"Relative to the CS-, the CS+ elicited stronger activation in the dorsal striatum, a brain region associated with cue-reward coupling.","['23 participants consumed unknown (marzipan) objects of one particular color (CS+) while only interacting with control stimuli of different color and shape (CS', 'humans']","[""denovo' Pavlovian appetitive conditioning, pairing one class of unknown objects (conditioned stimuli, CS) with their sweet taste (unconditioned stimulus, US""]","[""subjective 'craving"", 'palatability and desire to eat']","[{'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0234404', 'cui_str': 'Conditioned stimulus'}, {'cui': 'C0858600', 'cui_str': 'Taste sweet'}, {'cui': 'C0234403', 'cui_str': 'Unconditioned stimulus'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}]",23.0,0.0298472,"Relative to the CS-, the CS+ elicited stronger activation in the dorsal striatum, a brain region associated with cue-reward coupling.","[{'ForeName': 'Lender', 'Initials': 'L', 'LastName': 'A', 'Affiliation': 'Paris-Lodron-University of Salzburg, Department of Psychology, Centre for Cognitive Neuroscience, Hellbrunner Str. 34, 5020 Salzburg, Austria. Electronic address: anja.lender@sbg.ac.at.'}, {'ForeName': 'Miedl', 'Initials': 'M', 'LastName': 'Sf', 'Affiliation': 'Paris-Lodron-University of Salzburg, Department of Psychology, Division of Clinical Psychology and Psychopathology, Hellbrunner Str. 34, 5020 Salzburg, Austria.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Fh', 'Affiliation': 'Paris-Lodron-University of Salzburg, Department of Psychology, Division of Clinical Psychology and Psychopathology, Hellbrunner Str. 34, 5020 Salzburg, Austria.'}, {'ForeName': 'Miller', 'Initials': 'M', 'LastName': 'J', 'Affiliation': 'Paris-Lodron-University of Salzburg, Department of Psychology, Centre for Cognitive Neuroscience, Hellbrunner Str. 34, 5020 Salzburg, Austria.'}, {'ForeName': 'Blechert', 'Initials': 'B', 'LastName': 'J', 'Affiliation': 'Paris-Lodron-University of Salzburg, Department of Psychology, Centre for Cognitive Neuroscience, Hellbrunner Str. 34, 5020 Salzburg, Austria.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113014']
2813,32553680,Morphea-like skin lesions reported in the Phase III Long-term Odanacatib Fracture Trial (LOFT) in postmenopausal women with osteoporosis.,,2020,,['postmenopausal women with osteoporosis'],[],['Morphea-like skin lesions'],"[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}]",[],"[{'cui': 'C0036420', 'cui_str': 'Localized scleroderma'}, {'cui': 'C0037284', 'cui_str': 'Skin lesion'}]",,0.0179395,,"[{'ForeName': 'Kenneth G', 'Initials': 'KG', 'LastName': 'Saag', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Tobias J', 'Initials': 'TJ', 'LastName': 'de Villiers', 'Affiliation': 'Mediclinic Panorama and Department of Obstetrics & Gynaecology, University of Stellenbosch, Cape Town, South Africa.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Alexandersen', 'Affiliation': 'Center for Clinical and Basic Research, Vejle, Denmark.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Jacobe', 'Affiliation': 'Department of Dermatology, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Kovarik', 'Affiliation': 'Department of Dermatology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Victoria P', 'Initials': 'VP', 'LastName': 'Werth', 'Affiliation': 'Corporal Michael J. Crescenz VAMC, Philadelphia, PA, USA.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Leung', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Avani', 'Initials': 'A', 'LastName': 'Desai-Merchant', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Mattaliano', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Gurner', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA. Electronic address: deborah_gurner@merck.com.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.06.036']
2814,32553717,Plasma Pharmacokinetics and Urinary Excretion of Tenofovir Following Cessation in Adults with Controlled Levels of Adherence to Tenofovir Disoproxil Fumarate.,"OBJECTIVES


To fully characterize the plasma and urine washout pharmacokinetics of TFV in adults following 6 weeks of controlled levels of TDF adherence to inform the utility of clinic-based adherence testing.
DESIGN


A 3-arm randomized, open-label study in adult volunteers. Participants were randomized to receive TDF 300 mg/emtricitabine (FTC) 200 mg either: (i) 7 doses/week (Perfect Adherence), (ii) 4 doses/week (Moderate Adherence), or (iii) 2 doses/week (Low Adherence). Plasma and urine samples were regularly collected during the six-week dosing phase and four weeks following drug cessation.
RESULTS


Twenty-eight adults were included in this analysis. Median (range) age was 33 (20-49) years. No differences in TFV PK parameters during the washout were observed across arms. Small differences in TFV plasma concentrations occurred across arms between 4 to 10 hours post-dose. The cumulative amount of TFV excreted in urine was not different 24 hours post-dose, but at 148 hours was 24.8, 21.0 and 17.2 mg for the Perfect, Moderate and Low Adherence arms, respectively (p = 0.043).
CONCLUSIONS


Among adults with different TDF adherence patterns, relative differences in plasma concentrations and cumulative urine extraction of TFV were minor following cessation. TFV measurement in plasma or urine is more indicative of last drug ingestion rather than differentiating recent adherence patterns.",2020,"The cumulative amount of TFV excreted in urine was not different 24 hours post-dose, but at 148 hours was 24.8, 21.0 and 17.2 mg for the Perfect, Moderate and Low Adherence arms, respectively (p = 0.043).
","['Adults with Controlled Levels of Adherence to', 'adult volunteers', 'adults with different TDF adherence patterns', 'Median (range) age was 33 (20-49) years', 'Twenty-eight adults']","['Tenofovir Disoproxil Fumarate', 'TDF 300\u2009mg/emtricitabine (FTC']","['Plasma and urine samples', 'cumulative amount of TFV excreted in urine', 'TFV PK parameters', 'Plasma Pharmacokinetics and Urinary Excretion of Tenofovir', 'plasma concentrations and cumulative urine extraction of TFV', 'TFV measurement in plasma or urine', 'TFV plasma concentrations']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0619283', 'cui_str': 'IS 33'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4283787', 'cui_str': '28'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0206682', 'cui_str': 'Follicular thyroid carcinoma'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",28.0,0.0747984,"The cumulative amount of TFV excreted in urine was not different 24 hours post-dose, but at 148 hours was 24.8, 21.0 and 17.2 mg for the Perfect, Moderate and Low Adherence arms, respectively (p = 0.043).
","[{'ForeName': 'Tim R', 'Initials': 'TR', 'LastName': 'Cressey', 'Affiliation': 'PHPT/IRD, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand; Department of Immunology & Infectious Diseases, Boston, Harvard T.H Chan School of Public Health, MA, USA; Department of Molecular & Clinical Pharmacology, University of Liverpool, UK. Electronic address: tim.cressey@phpt.org.'}, {'ForeName': 'Oraphan', 'Initials': 'O', 'LastName': 'Siriprakaisil', 'Affiliation': 'Sanpatong Hospital, Chiang Mai, Thailand.'}, {'ForeName': 'Rachel W', 'Initials': 'RW', 'LastName': 'Kubiak', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, USA.'}, {'ForeName': 'Virat', 'Initials': 'V', 'LastName': 'Klinbuayaem', 'Affiliation': 'Sanpatong Hospital, Chiang Mai, Thailand.'}, {'ForeName': 'Pra-Ornsuda', 'Initials': 'PO', 'LastName': 'Sukrakanchana', 'Affiliation': 'PHPT/IRD, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Justice', 'Initials': 'J', 'LastName': 'Quame-Amaglo', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, USA.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Okochi', 'Affiliation': 'Department of Medicine, University of California-San Francisco (UCSF), San Francisco, USA.'}, {'ForeName': 'Yardpiroon', 'Initials': 'Y', 'LastName': 'Tawon', 'Affiliation': 'PHPT/IRD, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Ratchada', 'Initials': 'R', 'LastName': 'Cressey', 'Affiliation': 'Department of Medical Technology, Faculty of Associated Medical Sciences, Chiang Mai University, Thailand.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, USA; Department of Global Health, University of Washington, Seattle, USA; Department of Medicine, University of Washington, Seattle, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Gandhi', 'Affiliation': 'Department of Medicine, University of California-San Francisco (UCSF), San Francisco, USA.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Drain', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, USA; Department of Global Health, University of Washington, Seattle, USA; Department of Medicine, University of Washington, Seattle, USA.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.06.037']
2815,32554365,Comparison of efficacy between combined periarticular and incisional injections versus periarticular injection alone of bupivacaine for pain control after total knee arthroplasty: A prospective randomized controlled trial.,"OBJECTIVE


The aim of this study was to compare the efficacy of combined periarticular and incisional injections versus periarticular injection alone of bupivacaine in reducing post-operative pain after total knee arthroplasty (TKA).
METHODS


In this prospective, randomized, double-blind comparative study, 90 patients with primary osteoarthritis who underwent TKA were enrolled. The patients were then randomly divided into 3 groups (30 in each): group 1, without injection; group 2, with periarticular injection of 20 mL 0.5% bupivacaine hydrogen chloride (HCl) (100 mg) after implantation; and group 3, periarticular injection of 20 mL 0.5% bupivacaine HCl (100 mg) after implantation and incisional injection of 10 mL 0.5% bupivacaine HCl (50 mg) before wound closure. Post-operative pain levels were measured using a 100-mm visual analogue scale (VAS) (0 mm: no pain and 100 mm: worst pain) at 30 min and 1, 2, 4, and 6 h, post-operatively.
RESULTS


The mean VAS score in group 3 (the combined group-periarticular and incisional injections) within the first 4 h was lower than that in group 1 and group 2 (p<0.001). The mean VAS scores at the first 30 min were 65.21±9.46 in group 1, 51.86±5.96 in group 2, and 29.33±8.55 in group 3 (p<0.001). The mean VAS scores at the first 1 h were 64.43±9.32 in group 1, 47.26±4.77 in group 2, and 31.66±7.37 in group 3 (p<0.001). The mean scores at the 2 h were 61.46±8.62 in group 1, 48.33±4.66 in group 2, and 30.83±6.76 in group 3 (p<0.001). The mean scores at the 4 h were 64.72±8.91 in group 1, 47.53±4.35 in group 2, and 34.36±6.64 in group 3 (p<0.001). The differences were not significant at 6 h between group 2 (44.91±4.12) and group 3 (41.83±6.71) (p>0.001). However, the values were significantly lower than those of the control group (63.56±9.73) (p<0.001). In addition, VAS scores at all follow-up times were significantly higher in the control group compared with the other groups (p<0.001).
CONCLUSION


Evidence from this study revealed that the combined injection of bupivacaine is more effective than its periarticular injection alone and provides effective post-operative pain management after TKA.
LEVEL OF EVIDENCE


Level I, Therapeutic study.",2020,"In addition, VAS scores at all follow-up times were significantly higher in the control group compared with the other groups (p<0.001).
","['90 patients with primary osteoarthritis who underwent TKA were enrolled', 'pain control after total knee arthroplasty', 'after total knee arthroplasty (TKA']","['combined periarticular and incisional injections versus periarticular injection alone of bupivacaine', 'periarticular injection of 20 mL 0.5% bupivacaine hydrogen chloride (HCl) (100 mg) after implantation; and group 3, periarticular injection of 20 mL 0.5% bupivacaine HCl (100 mg) after implantation and incisional injection of 10 mL 0.5% bupivacaine HCl', 'bupivacaine']","['mean scores', '100-mm visual analogue scale (VAS', 'Post-operative pain levels', 'mean VAS scores', 'post-operative pain', 'mean VAS score', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409952', 'cui_str': 'Idiopathic osteoarthritis'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0595695', 'cui_str': 'Periarticular route'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0020259', 'cui_str': 'Hydrochloric Acid'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",90.0,0.0690695,"In addition, VAS scores at all follow-up times were significantly higher in the control group compared with the other groups (p<0.001).
","[{'ForeName': 'Nuray', 'Initials': 'N', 'LastName': 'Altay', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Harran University, School of Medicine, Şanlıurfa, Turkey.'}, {'ForeName': 'Baran', 'Initials': 'B', 'LastName': 'Sarıkaya', 'Affiliation': 'Department of Orthopedics and Traumatology, Harran University, School of Medicine, Şanlıurfa, Turkey.'}, {'ForeName': 'Mahmut Alp', 'Initials': 'MA', 'LastName': 'Karahan', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Harran University, School of Medicine, Şanlıurfa, Turkey.'}, {'ForeName': 'Evren', 'Initials': 'E', 'LastName': 'Büyükfırat', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Harran University, School of Medicine, Şanlıurfa, Turkey.'}, {'ForeName': 'Orhan', 'Initials': 'O', 'LastName': 'Binici', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Harran University, School of Medicine, Şanlıurfa, Turkey.'}, {'ForeName': 'Cemil', 'Initials': 'C', 'LastName': 'Ertürk', 'Affiliation': 'Deparment of Orthopedics and Traumatology, Health Sciences University Kanuni Sultan Süleyman Training and Research Hospital, İstanbul, Turkey.'}, {'ForeName': 'Mehmet Akif', 'Initials': 'MA', 'LastName': 'Altay', 'Affiliation': 'Department of Orthopedics and Traumatology, Harran University, School of Medicine, Şanlıurfa, Turkey.'}]",Acta orthopaedica et traumatologica turcica,['10.5152/j.aott.2020.20212']
2816,32554368,A Web-Based Intervention for Young Adults Whose Parents Have a Mental Illness or Substance Use Concern: Protocol for a Randomized Controlled Trial.,"BACKGROUND


One in 5 young people grow up in a family where one parent has experienced a mental health problem or substance use concern. Compared with their same-aged peers, these youth are at a higher risk of academic failure and acquiring a substance abuse and/or mental health issue. There is a paucity of accessible, age-appropriate interventions that address their needs.
OBJECTIVE


A 6-week, web-based intervention, ""mental illness: supported, preventative, online, targeted"" (mi.spot), was developed based on previous research and the competence enhancement model. This paper describes the protocol for a randomized controlled trial and details how the usage, safety, acceptability, and feasibility of the intervention will be determined.
METHODS


Participants will be recruited through social media and clinician referral. A total of 70 Australians, aged 18 to 25 years, who grew up with parents with a mental illness or substance use concern will participate in a 2-arm parallel randomized controlled trial. The assessment will consist of a baseline measurement and 2 follow-up periods, posttest and 6-week follow-up, using the Mental Health Continuum short form; the Depression, Anxiety, and Stress Scale; the Coping Orientation to Problems Experienced inventory; the General Help Seeking Questionnaire; the Social Connectedness Scale; the Mental Health Literacy Scale; the General Self-Efficacy Scale; and the Attribution of Responsibility for Parental Mental Illness Measure. Impact will be examined at pre, post, and follow-up time periods using analyses of variance that will include a within-subjects factor (time) and a between-subjects factor (intervention/control). Facilitator interviews will ascertain intervention feasibility. Participant interviews will ascertain intervention acceptability. Interview data will be analyzed within a qualitative framework. Usage (data analytics) across site features and several indicators of clinical safety will also be reported.
RESULTS


The impact of mi.spot will be examined at pre, post, and follow-up time periods using analyses of variance on each of the measures outlined above. There will be a within-subjects factor (time) and a between-subjects factor (intervention/control). Data analysis will employ the intention-to-treat principle by including all participants in the analyses. Qualitative interview data will be analyzed using interpretative phenomenological analysis along with respondent validation. The Monash University Human Research Ethics Committee (reference number: 2019-18660-30434) approved the trial on April 17, 2019. As of October 2, 2019, 30 participants were enrolled in the control group and 34 participants were enrolled in the intervention group. Result are expected to be submitted for publication in December 2020.
CONCLUSIONS


Study results will provide reliable evidence on a web-based intervention that has the potential to make a difference to the lives of many vulnerable young adults. Implementation guidelines are needed to embed the intervention in different service sectors.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry ACTRN12619000335190; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12619000335190.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/15626.",2020,"Compared with their same-aged peers, these youth are at a higher risk of academic failure and acquiring a substance abuse and/or mental health issue.","['A total of 70 Australians, aged 18 to 25 years, who grew up with parents with a mental illness or substance use concern', '30 participants were enrolled in the control group and 34 participants were enrolled in the intervention group', 'Young Adults', 'Participants will be recruited through social media and clinician referral']",[],['Mental Health Literacy Scale; the General Self-Efficacy Scale; and the Attribution of Responsibility for Parental Mental Illness Measure'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}]",[],"[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",30.0,0.142765,"Compared with their same-aged peers, these youth are at a higher risk of academic failure and acquiring a substance abuse and/or mental health issue.","[{'ForeName': 'Darryl', 'Initials': 'D', 'LastName': 'Maybery', 'Affiliation': 'School of Rural Health, Monash University, Warragul, Australia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Reupert', 'Affiliation': 'Faculty of Education, Monash University, Clayton, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Bartholomew', 'Affiliation': 'Wellways, Melbourne, Australia.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Cuff', 'Affiliation': 'Bouverie Centre, Melbourne, Australia.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Duncan', 'Affiliation': 'School of Rural Health, Monash University, Warragul, Australia.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Foster', 'Affiliation': 'School of Nursing, Midwifery & Paramedicine, Australian Catholic University, Melbourne, Australia.'}, {'ForeName': 'Jodie', 'Initials': 'J', 'LastName': 'Matar', 'Affiliation': 'Faculty of Education, Monash University, Clayton, Australia.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pettenuzzo', 'Affiliation': 'Faculty of Education, Monash University, Clayton, Australia.'}]",JMIR research protocols,['10.2196/15626']
2817,32554380,"Effectiveness of an Eight-Week Web-Based Mindfulness Virtual Community Intervention for University Students on Symptoms of Stress, Anxiety, and Depression: A Randomized Controlled Trial.","BACKGROUND


A student mental health crisis is increasingly acknowledged and will only intensify with the COVID-19 crisis. Given accessibility of methods with demonstrated efficacy in reducing depression and anxiety (e.g., mindfulness meditation and cognitive behavioural therapy [CBT]) and limitations imposed by geographic obstructions and localized expertise, web-based alternatives have become vehicles for scaled-up delivery of benefits at modest cost. Mindfulness Virtual Community (MVC), a web-based program informed by cognitive behavioral therapy (CBT) constructs and featuring online videos, discussion forums, and videoconferencing was developed to target depression, anxiety, and experiences of excess stress among university students.
OBJECTIVE


Assessment of an eight-week web-based mindfulness and cognitive behavioural therapy (CBT) program in reducing symptoms of depression, anxiety, and stress (primary outcomes) and increasing mindfulness (secondary outcome) within a randomized controlled trial (RCT) with undergraduate students at a large Canadian university.
METHODS


An RCT was designed to assess undergraduate students (n = 160) who were randomly allocated to a web-based guided mindfulness-CBT condition (n = 80) or to a waitlist control condition (WLC) (n = 80). The eight-week intervention consisted of a web-based platform consisting of (1) 12 video-based modules with psycho-education on students' preidentified life challenges and applied mindfulness practice; (2) anonymous peer-to-peer discussion forums; and (3) anonymous, group-based, professionally guided 20-minute live videoconferences. The outcomes (depression, anxiety, stress, and mindfulness) were measured via online survey at baseline and at eight weeks post-intervention using the Patient Health Questionniare-9 (PHQ9), the Beck Anxiety Inventory (BAI), the Perceived Stress Scale (PSS), and the Five Facets Mindfulness Questionnaire Short Form (FFMQ-SF). Analyses employed generalized estimation equation (GEE) methods with AR(1) covariance structures and were adjusted for possible covariates (gender, age, country of birth, ethnicity, English as first language, paid work, unpaid work, relationship status, physical exercise, self-rated health, and access to private mental health counselling).
RESULTS


Of the 159 students who provided T1 data, 32 were males and 125 were females with a mean age of 22.55 years. Participants in the MVC (n = 79) and WLC (n = 80) groups were similar in sociodemographic characteristics at T1 with the exception of gender and weekly hours of unpaid volunteer work. At post-intervention follow-up, per the adjusted comparisons, there were statistically significant between-group reductions in depression scores (β = -2.21, P = .01) and anxiety scores (β = -4.82, P = .006) and a significant increase in mindfulness scores (β = 4.84, P = .02) compared to WLC. There were no statistically significant differences in perceived stress for MVC (β = .64, P = .48) compared to WLC.
CONCLUSIONS


With MVC intervention, there were significantly reduced depression and anxiety symptoms but no significant effect on perceived stress. Online mindfulness interventions can be effective in addressing common mental health conditions among post-secondary populations on a large scale, simultaneously reducing the current burden on traditional counselling services.
CLINICALTRIAL


https://doi.org/10.1186/ISRCTN12249616.",2020,"There were no statistically significant differences in perceived stress for MVC (β = .64, P = .48) compared to WLC.
","['32 were males and 125 were females with a mean age of 22.55 years', 'undergraduate students at a large Canadian university', 'undergraduate students (n = 160', '159 students who provided T1 data', 'Participants in the MVC (n = 79) and WLC (n = 80) groups were similar in sociodemographic characteristics at T1 with the exception of gender and weekly hours of unpaid volunteer work', 'University Students on Symptoms of Stress, Anxiety, and Depression', 'university students']","['web-based guided mindfulness-CBT condition (n = 80) or to a waitlist control condition (WLC', 'Eight-Week Web-Based Mindfulness Virtual Community Intervention', 'mindfulness meditation and cognitive behavioural therapy [CBT', 'Mindfulness Virtual Community (MVC), a web-based program informed by cognitive behavioral therapy (CBT) constructs and featuring online videos, discussion forums, and videoconferencing', 'eight-week web-based mindfulness and cognitive behavioural therapy (CBT) program', 'Online mindfulness interventions', ""web-based platform consisting of (1) 12 video-based modules with psycho-education on students' preidentified life challenges and applied mindfulness practice; (2) anonymous peer-to-peer discussion forums; and (3) anonymous, group-based, professionally guided 20-minute live videoconferences""]","['mindfulness scores', 'outcomes (depression, anxiety, stress, and mindfulness', 'depression scores', 'Patient Health Questionniare-9 (PHQ9), the Beck Anxiety Inventory (BAI), the Perceived Stress Scale (PSS), and the Five Facets Mindfulness Questionnaire Short Form (FFMQ-SF', 'depression and anxiety symptoms', 'anxiety scores', 'symptoms of depression, anxiety, and stress (primary outcomes', 'perceived stress for MVC']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1450049', 'cui_str': 'Videoconference'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009462', 'cui_str': 'Community'}]",160.0,0.0566538,"There were no statistically significant differences in perceived stress for MVC (β = .64, P = .48) compared to WLC.
","[{'ForeName': 'Christo', 'Initials': 'C', 'LastName': 'El Morr', 'Affiliation': 'York University, School of Health Policy and Management, 4700 Keele St. Stong #350, Toronto, CA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ritvo', 'Affiliation': 'York University, School of Kinesiology and Health Science, Toronto, CA.'}, {'ForeName': 'Farah', 'Initials': 'F', 'LastName': 'Ahmad', 'Affiliation': 'York University, School of Health Policy and Management, 4700 Keele St. Stong #350, Toronto, CA.'}, {'ForeName': 'Rahim', 'Initials': 'R', 'LastName': 'Moineddin', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, CA.'}]",JMIR mental health,['10.2196/18595']
2818,32554385,Supplemental Text Message Support With the National Diabetes Prevention Program: Pragmatic Comparative Effectiveness Trial.,"BACKGROUND


The evidence-based National Diabetes Prevention Program (NDPP) is now widely disseminated, yet strategies to increase its effectiveness are needed, especially for underserved populations. The yearlong program promotes lifestyle changes for weight loss and can be offered in-person, online, via distance learning, or a combination of modalities. Less is known about which delivery features are optimal and may help address disparities in outcomes for subgroups. We previously demonstrated the efficacy of a stand-alone text messaging intervention based on the NDPP (SMS4PreDM) in a randomized controlled trial in a safety net health care system. Upon broader dissemination, we then showed that SMS4PreDM demonstrated high retention and modest weight loss at a relatively low cost, suggesting the potential to improve in-person NDPP delivery.
OBJECTIVE


In this study, we aim to compare the effectiveness of in-person NDPP classes with and without supplementary SMS4PreDM on attendance and weight loss outcomes to determine whether text messaging can enhance in-person NDPP delivery for a safety net patient population.
METHODS


From 2015 to 2017, patients with diabetes risks were identified primarily from provider referrals and enrolled in NDPP classes, SMS4PreDM, or both per their preference and availability. Participants naturally formed three groups: in-person NDPP with SMS4PreDM (n=236), in-person NDPP alone (n=252), and SMS4PreDM alone (n=285). This analysis compares the first two groups to evaluate whether supplemental text messaging may improve in-person NDPP outcomes. Outcomes for SMS4PreDM-only participants were previously reported. NDPP classes followed standard delivery guidelines, including weekly-to-monthly classes over a year. SMS4PreDM delivery included messages promoting lifestyle change and modest weight loss, sent 6 days per week for 12 months. Differences in characteristics between intervention groups were assessed using chi-square and t tests. Differences in NDPP attendance and weight loss outcomes were analyzed with multivariable linear and logistic regressions.
RESULTS


The mean age was 50.4 years (SD 13.9). Out of a total of 488 participants, 76.2% (n=372) were female and 59.0% (n=288) were Hispanic. An additional 17.2% (n=84) were non-Hispanic white and 12.9% (n=63) were non-Hispanic black. A total of 48.4% (n=236) of participants elected to receive supplemental text message support in addition to NDPP classes. Participants who chose supplemental text message support were on average 5.7 (SD 1.2) years younger (P<.001) than the 252 participants who preferred in-person classes alone. Relatively more women and Hispanic individuals enrolled in the NDPP with supplemental text messages than in NDPP classes alone, 83.9% (n=198) vs 69.0% (n=174, P<.001) and 68.6% (n=162) vs 50.0% (n=126, P=.001), respectively. Attendance and weight loss outcomes were comparable between groups.
CONCLUSIONS


Despite its appeal among priority populations, supplemental text messaging did not significantly increase attendance and weight loss for the in-person NDPP. Further research is needed to identify optimal strategies to improve the effectiveness of the NDPP.",2020,"Despite its appeal among priority populations, supplemental text messaging did not significantly increase attendance and weight loss for the in-person NDPP.","['An additional 17.2% (n=84) were non-Hispanic white and 12.9% (n=63) were non-Hispanic black', 'patients with diabetes risks were identified primarily from provider referrals and enrolled in NDPP classes, SMS4PreDM, or both per their preference and availability', 'From 2015 to 2017', 'Participants naturally formed three groups: in-person NDPP with SMS4PreDM (n=236), in-person NDPP alone (n=252), and SMS4PreDM alone (n=285', 'Out of a total of 488 participants, 76.2% (n=372) were female and 59.0% (n=288) were Hispanic', 'The mean age was 50.4 years (SD 13.9', 'Participants who chose supplemental text message support were on average 5.7 (SD 1.2) years younger (P<.001) than the 252 participants who preferred in-person classes alone']","['SMS4PreDM', 'NDPP (SMS4PreDM', 'supplemental text messaging', 'Supplemental Text Message Support With the National Diabetes Prevention Program', 'stand-alone text messaging intervention', 'person NDPP classes with and without supplementary SMS4PreDM']","['weight loss', 'NDPP attendance and weight loss outcomes', 'Attendance and weight loss outcomes', 'attendance and weight loss']","[{'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517562', 'cui_str': '13.9'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}]","[{'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0560204', 'cui_str': 'Does stand alone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",488.0,0.157848,"Despite its appeal among priority populations, supplemental text messaging did not significantly increase attendance and weight loss for the in-person NDPP.","[{'ForeName': 'Natalie D', 'Initials': 'ND', 'LastName': 'Ritchie', 'Affiliation': 'Denver Health, Denver, CO, United States.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Gutiérrez-Raghunath', 'Affiliation': 'Denver Health, Denver, CO, United States.'}, {'ForeName': 'Michael Josh', 'Initials': 'MJ', 'LastName': 'Durfee', 'Affiliation': 'Denver Health, Denver, CO, United States.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Fischer', 'Affiliation': 'Denver Health, Denver, CO, United States.'}]",JMIR mHealth and uHealth,['10.2196/15478']
2819,32554646,"Study design of the Fasting In diabetes Treatment (FIT) trial: a randomised, controlled, assessor blinded intervention trial which examines the effect of intermittent use of a fasting mimicking diet in patients with type 2 diabetes.","BACKGROUND


Caloric restriction is an effective way to treat type 2 diabetes (DM2). However, chronic restriction of food intake is difficult to sustain. Intermittent total fasting exerts similar metabolic effects, but may be even more challenging for most patients. A fasting mimicking diet (FMD) was designed to achieve the metabolic benefits of total fasting, despite considerable calorie content. The effects of a FMD in DM2 patients are still unknown.
AIM


To determine the effect of intermittent use (5 consecutive days a month during a year) of a FMD in DM2 patients on metabolic parameters and DM2 medication use compared to usual care.
METHOD


One hundred DM2 patients from general practices in the Netherlands with a BMI ≥ 27 kg/m 2 , treated with lifestyle advice only or metformin, will be randomised to receive the FMD plus usual care or usual care only. Primary outcomes are HbA1c and DM2 medication dosage. Secondary outcomes are anthropometrics, blood pressure, plasma lipid profiles, quality of life, treatment satisfaction, metabolomics, microbiome, MRI (for example, cardiac function and fat distribution), cost-effectiveness, and feasibility in clinical practice.
RESULTS


The first 70 patients are included. Follow up will be completed in April 2021.
CONCLUSION


Our results will show whether monthly cycles of a FMD are feasible in clinical practice, if they improve metabolic parameters and/or reduce the need for medication in DM2 and if this is a cost-effective intervention.",2020,"A fasting mimicking diet (FMD) was designed to achieve the metabolic benefits of total fasting, despite considerable calorie content.","['DM2 patients', 'One hundred DM2 patients from general practices in the Netherlands with a BMI ≥ 27 kg/m 2 , treated with lifestyle advice only or', '70 patients are included', 'patients with type 2 diabetes']","['fasting mimicking diet', 'FMD plus usual care or usual care only', 'metformin', 'Fasting']","['HbA1c and DM2 medication dosage', 'anthropometrics, blood pressure, plasma lipid profiles, quality of life, treatment satisfaction, metabolomics, microbiome, MRI (for example, cardiac function and fat distribution), cost-effectiveness, and feasibility in clinical practice']","[{'cui': 'C1300562', 'cui_str': 'dm2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C1300562', 'cui_str': 'dm2'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",100.0,0.0760141,"A fasting mimicking diet (FMD) was designed to achieve the metabolic benefits of total fasting, despite considerable calorie content.","[{'ForeName': 'Elske', 'Initials': 'E', 'LastName': 'van den Burg', 'Affiliation': 'Public Health and Primary Care, Leiden University Medical Center.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Schoonakker', 'Affiliation': 'Public Health and Primary Care, Leiden University Medical Center.'}, {'ForeName': 'Elske', 'Initials': 'E', 'LastName': 'van den Akker', 'Affiliation': 'Medical Decision Making, Leiden University Medical Center.'}, {'ForeName': 'Ko Willems', 'Initials': 'KW', 'LastName': 'van Dijk', 'Affiliation': 'Human Genetics, Leiden University Medical Center.'}, {'ForeName': 'Hildo', 'Initials': 'H', 'LastName': 'Lamb', 'Affiliation': 'Radiology, Leiden University Medical Center.'}, {'ForeName': 'Hanno', 'Initials': 'H', 'LastName': 'Pijl', 'Affiliation': 'Internal Medicine, Leiden University Medical Center.'}, {'ForeName': 'Mattijs', 'Initials': 'M', 'LastName': 'Numans', 'Affiliation': 'Public Health and Primary Care, Leiden University Medical Center.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'van Peet', 'Affiliation': 'Public Health and Primary Care, Leiden University Medical Center.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/bjgp20X711173']
2820,32554648,Anticipatory care planning for older adults: a trans-jurisdictional feasibility study.,"BACKGROUND


As the population of older adults' increases, the complexity of care required to support those who choose to remain in the community has also increased. Anticipatory Care Planning (ACP) through earlier identification of healthcare needs is evidenced to improve quality of life, decrease the number of aggressive futile interventions, and even to prolong life.
AIM


To determine the feasibility of a cluster randomised trial to evaluate the implementation and outcomes of Anticipatory Care Planning (ACP) in primary care to assist older adults identified as at risk for functional decline by developing a personalised support plan.
METHOD


GP practices were randomised into control/intervention groups stratified by jurisdiction [Northern Ireland (UK) and the Republic of Ireland (RoI)], and by setting (urban and rural). Participants were included if they were a) aged ≥70 years, b) 2 or more chronic medical conditions, c) 4 or more prescribed medications. The Anticipatory Care Plan consisted of home visits where the study nurse discussed patients' goals and plans. An action plan was put in place following consultation with patient's GPs and study Pharmacist.
RESULTS


Eight primary care practices participated; four in the UK and four in the RoI. Sample  n  = 64. Data was collected pertaining to patient quality of life, mental health, healthcare utilisation, costs, perception of person-centred care, and the use of potentially inappropriate medication.
CONCLUSION


Unique insights relating to the trans-jurisdictional delivery of healthcare services in the UK and RoI were observed which has implications on service delivery for older adults.",2020,"To determine the feasibility of a cluster randomised trial to evaluate the implementation and outcomes of Anticipatory Care Planning (ACP) in primary care to assist older adults identified as at risk for functional decline by developing a personalised support plan.
","['primary care to assist older adults', 'GP practices', 'older adults', 'Participants were included if they were a) aged ≥70 years, b) 2 or more chronic medical conditions, c) 4 or more prescribed medications']","['Anticipatory care planning', 'control/intervention groups stratified by jurisdiction [Northern Ireland (UK) and the Republic of Ireland (RoI', 'Anticipatory Care Planning (ACP']","['patient quality of life, mental health, healthcare utilisation, costs, perception of person-centred care, and the use of potentially inappropriate medication']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}]","[{'cui': 'C0178916', 'cui_str': 'Care plan'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0028415', 'cui_str': 'Northern Ireland'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}]",,0.044586,"To determine the feasibility of a cluster randomised trial to evaluate the implementation and outcomes of Anticipatory Care Planning (ACP) in primary care to assist older adults identified as at risk for functional decline by developing a personalised support plan.
","[{'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Corry', 'Affiliation': 'Queens University Belfast.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Doherty', 'Affiliation': 'Queens University Belfast.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'McCann', 'Affiliation': 'Queens University Belfast.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Doyle', 'Affiliation': 'Royal College of Surgeons Ireland.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Cardwell', 'Affiliation': 'Queens University Belfast.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Carter', 'Affiliation': 'Queens University Belfast.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Clarke', 'Affiliation': 'Queens University Belfast.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Fahey', 'Affiliation': 'Royal College of Surgeons Ireland.'}, {'ForeName': 'Paddy', 'Initials': 'P', 'LastName': 'Gillespie', 'Affiliation': 'National University of Ireland Galway.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'McGlade', 'Affiliation': 'Queens University Belfast.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': ""O'Halloran"", 'Affiliation': 'Queens University Belfast.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Wallace', 'Affiliation': 'Royal College of Surgeons Ireland.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Brazil', 'Affiliation': 'Queens University Belfast.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/bjgp20X711197']
2821,32554653,MULTIPAP Study: Improving healthcare for patients with multimorbidity.,"BACKGROUND


The steady rise in multimorbidity entails serious consequences for our populations, challenges healthcare systems, and calls for specific clinical approaches of proven effectiveness. The MULTIPAP Study comprises three sequential projects (MULTIPAP and MULTIPAP Plus RCTs, and the MULTIPAP Cohort). Results of MULTIPAP RCT are presented.
AIM


To evaluate the effectiveness of a complex, patient-centred intervention in young-old patients with multimorbidity and polypharmacy.
METHOD


Pragmatic cluster-randomised clinical trial in a primary healthcare setting. GPs were randomly allocated to either conventional care or the MULTIPAP intervention based on the Ariadne Principles with two components: GPs e-training (that is, eMULTIPAP addresses specific, key concepts on multimorbidity, polypharmacy and shared decision-making) and GP-patient-centred interview. Young-old patients aged 65-74 years with multimorbidity and polypharmacy were included.
MAIN OUTCOME


difference in the Medication Appropriateness Index (MAI) after 6-month follow-up between groups.
SECONDARY OUTCOMES


MAI, quality of life, patient perception, health services use, treatment adherence and cost-effectiveness after 12-month follow-up.
RESULTS


117 GPs from 38 Spanish primary health care recruited 593 patients randomly assigned to the intervention/control groups. Difference in MAI scores between groups in the intention-to-treat analysis after 6 months' follow-up: -2.42 (-4.27 to -0.59),  P  = 0.009 (adjusted difference in mean MAI score -1.81(-3.35 to -0.27),  P  = 0.021).
SECONDARY OUTCOMES


not significant, including quality of life (adjusted difference in mean EQ-5D-5L (VAS) 2.94 (-1.39 to 7.28),  P  = 0.183, EQ-5D-5L (index) -0.006(-0.034 to 0.022),  P  = 0.689).
CONCLUSION


The intervention significantly improved medication appropriateness. The observed quality of life improvement was not significant. GPs e-training in multimorbidity has shown to be feasible and well accepted by the professionals. Future studies may test whether this format facilitates implementation.",2020,"SECONDARY OUTCOMES


not significant, including quality of life (adjusted difference in mean EQ-5D-5L (VAS) 2.94 (-1.39 to 7.28),  P  = 0.183, EQ-5D-5L (index) -0.006(-0.034 to 0.022),  P  = 0.689).
","['Pragmatic cluster-randomised clinical trial in a primary healthcare setting', 'patients with multimorbidity', '117 GPs from 38 Spanish primary health care recruited 593 patients randomly assigned to the intervention/control groups', 'Young-old patients aged 65-74 years with multimorbidity and polypharmacy were included', 'young-old patients with multimorbidity and polypharmacy']","['MULTIPAP', 'complex, patient-centred intervention', 'MULTIPAP RCT', 'conventional care or the MULTIPAP intervention based on the Ariadne Principles with two components: GPs e-training']","['quality of life', 'observed quality of life improvement', 'mean EQ-5D-5L (VAS', 'mean MAI score', 'MAI scores', 'MAI, quality of life, patient perception, health services use, treatment adherence and cost-effectiveness', 'medication appropriateness', 'Medication Appropriateness Index (MAI']","[{'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0272302', 'cui_str': 'Gray platelet syndrome'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0272302', 'cui_str': 'Gray platelet syndrome'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C4046084', 'cui_str': 'Medication Appropriateness Index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",593.0,0.085902,"SECONDARY OUTCOMES


not significant, including quality of life (adjusted difference in mean EQ-5D-5L (VAS) 2.94 (-1.39 to 7.28),  P  = 0.183, EQ-5D-5L (index) -0.006(-0.034 to 0.022),  P  = 0.689).
","[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Prados-Torres', 'Affiliation': 'EpiChron Research Group on Chronic Diseases, Aragon Health Sciences Institute, Miguel Servet University Hospital, Zaragoza, Spain.'}, {'ForeName': 'Isabel Del', 'Initials': 'ID', 'LastName': 'Cura-González', 'Affiliation': 'Primary Care Research Unit, Gerencia de Atención Primaria. Department of Preventive Medicine and Public Health, University Rey Juan Carlos, Madrid, Spain.'}, {'ForeName': 'Juan Daniel', 'Initials': 'JD', 'LastName': 'Prados-Torres', 'Affiliation': ""Multiprofesional Teaching Unit of Community and Family Atention 'Distrito Atención Primaria Málaga-Guadalhorce', Málaga, Spain.""}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Muth', 'Affiliation': 'Institute of General Practice, Johann Wolfgang Goethe University, Frankfurt/Main, Germany.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Leiva-Fernández', 'Affiliation': ""Multiprofesional Teaching Unit of Community and Family Atention 'Distrito Atención Primaria Málaga-Guadalhorce', Andalusian Health Service, Málaga, Spain.""}, {'ForeName': 'Juan A', 'Initials': 'JA', 'LastName': 'Lopez-Rodriguez', 'Affiliation': 'Primary Care Research Unit, Gerencia de Atención Primaria. Department of Preventive Medicine and Public Health, University Rey Juan Carlos, General Ricardos Primary Health Care Centre, Madrid, Spain.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'González-Rubio', 'Affiliation': 'EpiChron Research Group on Chronic Diseases, Aragon Health Sciences Institute, Aragón; Miguel Servet University Hospital, Delicias-Sur Primary Care Health Centre, SALUD, Zaragoza, Spain.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/bjgp20X711257']
2822,32554688,Multiple risk behaviour intervention to prevent depression in primary care.,"BACKGROUND


Primary care is the ideal setting for promotion and prevention intervention. Multiple risk behaviour interventions present several advantages over single-risk lifestyle interventions. Multiple risk behaviour interventions could be easily implemented in primary care to prevent non-communicable disease and depression.
AIM


To test the effectiveness of a multiple risk behaviour intervention to promote Mediterranean diet, physical activity, and/or smoking cessation in people attending Spanish primary health care with incidence of depression and symptoms of depression.
METHOD


This was a secondary analysis of the EIRA study that aims to test the effectiveness of a multiple risk behaviour intervention to promote healthy lifestyles. Twenty-six primary care centres were randomised to receive multiple risk behaviour intervention or usual care. The multiple risk behaviour intervention included individual sessions, group sessions, communitarian activities, and SMS reception. Participants were followed for 10-14 months. The primary outcomes of this study were incidence of depression and reductions of depressive symptoms.
RESULTS


Three thousand and sixty-seven participants were included. Females accounted for 45.13% and 93.88% were Spanish. Age varied between 45 and 75 years old. The effectiveness of the intervention will be calculated using the Patient Health Questionnaire (PHQ-9) and the Composite International Diagnostic Interview (‎CIDI)‎ depression section. Linear and logistic regression will be used to create predictive models.
CONCLUSION


Primary care is the most accessible service in the health system for patients. Hence primary care is the ideal setting for health education, promotion, and prevention interventions. This study will provide high-quality evidence about the effectiveness of multiple risk behaviour interventions over depression prevention.",2020,The effectiveness of the intervention will be calculated using the Patient Health Questionnaire (PHQ-9) and the Composite International Diagnostic Interview (‎CIDI)‎ depression section.,"['Age varied between 45 and 75 years old', 'people attending Spanish primary health care with incidence of depression and symptoms of depression', 'Twenty-six primary care centres', 'Three thousand and sixty-seven participants were included', 'healthy lifestyles']","['multiple risk behaviour intervention to promote Mediterranean diet, physical activity, and/or smoking cessation', 'multiple risk behaviour intervention', 'multiple risk behaviour intervention or usual care', 'Multiple risk behaviour intervention']","['communitarian activities, and SMS reception', 'Patient Health Questionnaire (PHQ-9) and the Composite International Diagnostic Interview (\u200eCIDI)\u200e depression section', 'incidence of depression and reductions of depressive symptoms']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0451085', 'cui_str': 'Composite international diagnostic interview'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",3067.0,0.0338549,The effectiveness of the intervention will be calculated using the Patient Health Questionnaire (PHQ-9) and the Composite International Diagnostic Interview (‎CIDI)‎ depression section.,"[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Gómez-Gómez', 'Affiliation': 'Universidad Loyola Andalucía.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Moreno-Peral', 'Affiliation': 'Network for Prevention and Health Promotion in Primary Care.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'López', 'Affiliation': 'Network for Prevention and Health Promotion in Primary Care.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Clavería', 'Affiliation': 'Network for Prevention and Health Promotion in Primary Care.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Oliván', 'Affiliation': 'Network for Prevention and Health Promotion in Primary Care.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Marti', 'Affiliation': 'Network for Prevention and Health Promotion in Primary Care.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Llobera', 'Affiliation': 'Network for Prevention and Health Promotion in Primary Care.'}, {'ForeName': 'Jose-Angel', 'Initials': 'JA', 'LastName': 'Maderuelo-Fernández', 'Affiliation': 'Network for Prevention and Health Promotion in Primary Care.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Motrico', 'Affiliation': 'Universidad Loyola Andalucía.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/bjgp20X711677']
2823,32554735,Non-absorbable versus absorbable sutures for anterior colporrhaphy: study protocol for a randomised controlled trial in South Korea.,"INTRODUCTION


The anterior vaginal wall is the segment most commonly affected by prolapse. Traditionally, anterior vaginal wall prolapse is repaired via anterior colporrhaphy, which is known to have a high recurrence rate. Several factors might affect the outcome of anterior colporrhaphy, and the use of absorbable sutures might also be associated with the high recurrence rate because the sutures might not be able to retain adequate strength until the plicated pubocervical fascia remodels and regains maximum tensile strength. Nonetheless, no comparative data exist about the relative efficacy and safety of anterior colporrhaphy using non-absorbable versus absorbable sutures. The objective of this study is to compare the surgical outcomes of anterior colporrhaphy using non-absorbable sutures with those of anterior colporrhaphy using absorbable sutures.
METHODS AND ANALYSIS


This is a randomised, multicentre, superiority trial. Anterior colporrhaphy will be performed in a traditional manner with midline plication of the fibromuscular layer using either non-absorbable or absorbable sutures. The primary outcome is composite surgical success 1 year after surgery defined as the absence of all of the following: (1) anterior vaginal descent beyond the hymen, (2) the presence of vaginal bulge symptoms and (3) retreatment for recurrent anterior vaginal wall prolapse with either surgery or pessary. The secondary outcomes include the individual components of the composite primary end point, anatomical outcomes, condition-specific quality of life and adverse events related to anterior colporrhaphy. The planned number of participants is 192.
ETHICS AND DISSEMINATION


This study was approved by the Institutional Review Board of Seoul National University Hospital (H-1810-037-977). The results of the study will be published in peer-reviewed journals, and the findings will be presented at scientific meetings.
TRIAL REGISTRATION NUMBER


NCT03736811.",2020,"The secondary outcomes include the individual components of the composite primary end point, anatomical outcomes, condition-specific quality of life and adverse events related to anterior colporrhaphy.","['South Korea', 'Seoul National University Hospital (H-1810-037-977']","['absorbable versus absorbable sutures', 'anterior colporrhaphy using non-absorbable sutures', 'Anterior colporrhaphy', 'anterior colporrhaphy using absorbable sutures', 'anterior colporrhaphy using non-absorbable versus absorbable sutures', 'fibromuscular layer using either non-absorbable or absorbable sutures']","['composite surgical success 1\u2009year after surgery defined as the absence of all of the following: (1) anterior vaginal descent beyond the hymen, (2) the presence of vaginal bulge symptoms and (3) retreatment for recurrent anterior vaginal wall prolapse with either surgery or pessary', 'individual components of the composite primary end point, anatomical outcomes, condition-specific quality of life and adverse events related to anterior colporrhaphy']","[{'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0461643', 'cui_str': 'Absorbable suture'}, {'cui': 'C0195224', 'cui_str': 'Anterior colporrhaphy'}, {'cui': 'C0461628', 'cui_str': 'Non-absorbable suture'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0425852', 'cui_str': 'Anterior vaginal wall prolapse'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0195224', 'cui_str': 'Anterior colporrhaphy'}]",,0.129302,"The secondary outcomes include the individual components of the composite primary end point, anatomical outcomes, condition-specific quality of life and adverse events related to anterior colporrhaphy.","[{'ForeName': 'Myung Jae', 'Initials': 'MJ', 'LastName': 'Jeon', 'Affiliation': 'Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, The Republic of Korea jeonmj@snu.ac.kr.'}, {'ForeName': 'Dong Hoon', 'Initials': 'DH', 'LastName': 'Suh', 'Affiliation': 'Obstetrics and Gynecology, Seoul National University Bundang Hospital, Seongnam, The Republic of Korea.'}, {'ForeName': 'Chul Hong', 'Initials': 'CH', 'LastName': 'Kim', 'Affiliation': 'Obstetrics and Gynecology, Chonnam National University Medical School, Gwangju, The Republic of Korea.'}, {'ForeName': 'Hyun-Hee', 'Initials': 'HH', 'LastName': 'Cho', 'Affiliation': ""Obstetrics and Gynecology, The Catholic University of Korea, Eunpyeong St. Mary's Hospital, Seoul, The Republic of Korea.""}, {'ForeName': 'Jung-Ho', 'Initials': 'JH', 'LastName': 'Shin', 'Affiliation': 'Obstetrics and Gynecology, Korea University College of Medicine, Seoul, The Republic of Korea.'}, {'ForeName': 'Sa Ra', 'Initials': 'SR', 'LastName': 'Lee', 'Affiliation': 'Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, The Republic of Korea.'}, {'ForeName': 'Yong Wook', 'Initials': 'YW', 'LastName': 'Jung', 'Affiliation': 'Obstetrics and Gynecology, CHA Gangnam Medical Center, CHA University College of Medicine, Seoul, The Republic of Korea.'}, {'ForeName': 'Soo Rim', 'Initials': 'SR', 'LastName': 'Kim', 'Affiliation': ""Obstetrics and Gynecology, International St. Mary's Hospital, Catholic Kwandong University College of Medicine, Incheon, The Republic of Korea.""}, {'ForeName': 'Mi Kyung', 'Initials': 'MK', 'LastName': 'Kong', 'Affiliation': ""Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, The Republic of Korea.""}]",BMJ open,['10.1136/bmjopen-2019-034218']
2824,32554736,"Randomised, non-inferiority, controlled procedural outcomes TrIal comParing reverse T And Protrusion versus double-kissing and crush stenting: protocol of the TIP TAP I randomised trial.","INTRODUCTION


To assess the impact of 'reverse T and Protrusion' (TAP) technique on the outcome after stenting of true bifurcation lesions of the left main (LM) or proximal epicardial vessels as compared with double kissing (DK)-crush technique.
METHODS AND ANALYSIS


50 consecutive patients with true coronary bifurcation lesion (Medina 1,1,1 or 0,1,1) of the LM or the proximal main vessels, requiring a two-stent technique as first-line strategy at University Medical Center Mainz, are randomised in a 1:1 ratio to reverse TAP or DK-crush stenting. As recommended by best clinical practice, final angiographic result is evaluated and optical coherence tomographic (OCT) intracoronary imaging is performed to assess and optimise the final result. The primary end point is defined as the percentage of stent expansion in the side branch. Secondary end points consist of angiographic and procedural success (assessed until patient's discharge), procedural parameters (procedural time, fluoroscopy time, use of devices, X-ray dose) and OCT parameters expressing expansion of the stents. Safety parameters include all adverse events up to 6 months after discharge. A clinical, angiographic and intracoronary imaging control at 6 months is planned.
ETHICS AND DISSEMINATION


The protocol complies with good clinical practice and the ethical principles described in the Declaration of Helsinki and is approved by the local ethics committee. The results of the trial will be published as original article(s) in medical journals and/or as presentation at congresses.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT03714750).",2020,"To assess the impact of 'reverse T and Protrusion' (TAP) technique on the outcome after stenting of true bifurcation lesions of the left main (LM) or proximal epicardial vessels as compared with double kissing (DK)-crush technique.
","['50 consecutive patients with true coronary bifurcation lesion (Medina 1,1,1 or 0,1,1) of the LM or the proximal main vessels, requiring a two-stent technique as first-line strategy at University Medical Center Mainz']","[""reverse T and Protrusion' (TAP) technique"", 'double kissing (DK)-crush technique', 'T And Protrusion versus double-kissing and crush', 'TAP or DK-crush stenting', 'stenting', 'TIP TAP']","[""angiographic and procedural success (assessed until patient's discharge), procedural parameters (procedural time, fluoroscopy time, use of devices, X-ray dose) and OCT parameters expressing expansion of the stents"", 'percentage of stent expansion in the side branch', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205238', 'cui_str': 'True'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C0333056', 'cui_str': 'Protrusion'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0185060', 'cui_str': 'Crushing'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}]","[{'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",50.0,0.186743,"To assess the impact of 'reverse T and Protrusion' (TAP) technique on the outcome after stenting of true bifurcation lesions of the left main (LM) or proximal epicardial vessels as compared with double kissing (DK)-crush technique.
","[{'ForeName': 'Kudrat', 'Initials': 'K', 'LastName': 'Rakhimov', 'Affiliation': 'Kardiologie I, Universitätsmedizin Mainz, Mainz, Rheinland-Pfalz, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Buono', 'Affiliation': 'Kardiologie I, Universitätsmedizin Mainz, Mainz, Rheinland-Pfalz, Germany.'}, {'ForeName': 'Remzi', 'Initials': 'R', 'LastName': 'Anadol', 'Affiliation': 'Kardiologie I, Universitätsmedizin Mainz, Mainz, Rheinland-Pfalz, Germany.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Ullrich', 'Affiliation': 'Kardiologie I, Universitätsmedizin Mainz, Mainz, Rheinland-Pfalz, Germany.'}, {'ForeName': 'Maike', 'Initials': 'M', 'LastName': 'Knorr', 'Affiliation': 'Kardiologie I, Universitätsmedizin Mainz, Mainz, Rheinland-Pfalz, Germany.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Ahoopai', 'Affiliation': 'Kardiologie I, Universitätsmedizin Mainz, Mainz, Rheinland-Pfalz, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Münzel', 'Affiliation': 'Kardiologie I, Universitätsmedizin Mainz, Mainz, Rheinland-Pfalz, Germany.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Gori', 'Affiliation': 'Kardiologie I, Universitätsmedizin Mainz, Mainz, Rheinland-Pfalz, Germany tommaso.gori@unimedizin-mainz.de.'}]",BMJ open,['10.1136/bmjopen-2019-034264']
2825,32554737,Individual breastfeeding support with contingent incentives for low-income mothers in the USA: the 'BOOST (Breastfeeding Onset & Onward with Support Tools)' randomised controlled trial protocol.,"INTRODUCTION


National breastfeeding rates have improved in recent years, however, disparities exist by socioeconomic and psychosocial factors. Suboptimal breastfeeding overburdens the society by increasing healthcare costs. Existing breastfeeding supports including education and peer support have not been sufficient in sustaining breastfeeding rates especially among low-income women. The preliminary outcomes of contingent incentives for breastfeeding in addition to existing support show promising effects in sustaining breastfeeding among mothers in the Special Supplemental Nutrition Programme for women, infants and children (WIC).
METHODS AND ANALYSIS


This trial uses a parallel randomised controlled trial. This trial is conducted at two sites in separate states in the USA. Mothers who were enrolled in WIC and initiated breastfeeding are eligible. Participants (n=168) are randomised into one of the two study groups: (1) standard care control (SC) group consisting of WIC breastfeeding services plus home-based individual support or (2) SC plus breastfeeding incentives (SC +BFI) contingent on demonstrating successful breastfeeding. All participants receive standard breastfeeding services from WIC, home-based individual support and assessments. Participants in SC receive financial compensation based on the number of completed monthly home visits, paid in a lump sum at the end of the 6-month intervention period. Participants in SC +BFI receive an escalating magnitude of financial incentives contingent on observed breastfeeding, paid monthly during the intervention period, as well as bonus incentives for selecting full breastfeeding food packages at WIC. The primary hypothesis is that monthly incentives contingent on breastfeeding in SC +BFI will significantly increase rates of any breastfeeding compared with SC. The primary outcome is the rate of any breastfeeding over 12 months. Randomisation is completed in an automated electronic system. Staff conducting home visits for support and assessments are blinded to study groups.
ETHICS AND DISSEMINATION


The Advarra Institutional Review Board has approved the study protocol (Pro00033168). Findings will be disseminated to our participants, scientific communities, public health officials and any other interested community members.
TRIAL REGISTRATION NUMBER


NCT03964454.",2020,The primary hypothesis is that monthly incentives contingent on breastfeeding in SC +BFI will significantly increase rates of any breastfeeding compared with SC.,"['Mothers who were enrolled in WIC and initiated breastfeeding are eligible', 'Participants (n=168', 'mothers in the Special Supplemental Nutrition Programme for women, infants and children (WIC', 'low-income mothers in the USA']","['standard care control (SC) group consisting of WIC breastfeeding services plus home-based individual support or (2) SC plus breastfeeding incentives (SC +BFI) contingent on demonstrating successful breastfeeding', 'standard breastfeeding services from WIC, home-based individual support and assessments']",['rate of any breastfeeding over 12\u2009months'],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",,0.0985776,The primary hypothesis is that monthly incentives contingent on breastfeeding in SC +BFI will significantly increase rates of any breastfeeding compared with SC.,"[{'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Washio', 'Affiliation': 'Substance Use, Gender and Applied Research, RTI International, Research Triangle Park, North Carolina, USA ywashio@rti.org.'}, {'ForeName': 'Bradley N', 'Initials': 'BN', 'LastName': 'Collins', 'Affiliation': 'College of Public Health, Temple University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Hunt-Johnson', 'Affiliation': 'College of Public Health, Temple University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Zugui', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Value Institute, Christiana Care Health System, Newark, Delaware, USA.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Herrine', 'Affiliation': 'Obstetrics and Gynecology Department, Temple University Hospital, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hoffman', 'Affiliation': 'Obstetrics and Gynecology Department, Christiana Care Health System, Newark, Delaware, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Kilby', 'Affiliation': 'N.O.R.T.H., Inc-Philadelphia WIC program, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Chapman', 'Affiliation': 'Department of Exercise Science and Athletic Training, Springfield College, Springfield, Massachusetts, USA.'}, {'ForeName': 'Lydia M', 'Initials': 'LM', 'LastName': 'Furman', 'Affiliation': ""Department of Pediatrics, University Hospitals Rainbow Babies and Children's Hospital and Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.""}]",BMJ open,['10.1136/bmjopen-2019-034510']
2826,32554744,Effectiveness of cervical pessary compared to cervical cerclage with or without vaginal progesterone for the prevention of preterm birth in women with twin pregnancies and a short cervix: study protocol for a two-by-two factorial randomised clinical trial.,"INTRODUCTION


Women with twin pregnancies and a short cervix are at increased risk for preterm birth (PTB). Given the burden of prematurity and its attendant risks, the quest for effective interventions in twins has been an area of considerable research. Studies investigating the effectiveness of cervical cerclage, cervical pessary and vaginal progesterone in preventing PTB have yielded conflicting results. The aim of this study is to compare the effectiveness of cervical pessary and cervical cerclage with or without vaginal progesterone to prevent PTB in women with twin pregnancies and a cervical length (CL) ≤ 28 mm.
METHODS AND ANALYSIS


This multicentre, randomised clinical trial will be conducted at My Duc Hospital and My Duc Phu Nhuan Hospital, Vietnam. Asymptomatic women with twin pregnancies and a CL ≤28 mm, measured at 16-22 weeks' gestation, will be randomised in a 1:1:1:1 ratio to receive a cerclage, pessary, cerclage plus progesterone or pessary plus progesterone. Primary outcome will be PTB <34 weeks. Secondary outcomes will be maternal and neonatal complications. We preplanned a subgroup analysis according to CL from all women after randomisation and divided into four quartiles. Analysis will be conducted on an intention-to-treat basis. The rate of PTB <34 weeks' gestation in women with twin pregnancies and a cervix ≤28 mm and treated with pessary in our previous study at My Duc Hospital was 24.2%. A sample size of 340 women will be required to show or refute that cervical cerclage decreases the rate of PTB <34 weeks by 50% compared with pessary (from 24.2% to 12.1%, α level 0.05, power 80%, 5% lost to follow-up and protocol deviation). This study is not to be powered to assess interactions between interventions.
ETHICS AND DISSEMINATION


Ethical approval was obtained from the Institutional Ethics Committee of My Duc Hospital and informed patient consent was obtained before study enrolment. Results of the study will be submitted for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


NCT03863613 (date of registration: 4 March 2019).",2020,The rate of PTB <34 weeks' gestation in women with twin pregnancies and a cervix ≤28 mm and treated with pessary in our previous study at My Duc Hospital was 24.2%.,"['Women with twin pregnancies and a short cervix are at increased risk for preterm birth (PTB', 'women with twin pregnancies and a short cervix', ""Asymptomatic women with twin pregnancies and a CL ≤28\u2009mm, measured at 16-22 weeks' gestation"", 'My Duc Hospital and My Duc Phu Nhuan Hospital, Vietnam', '340 women', 'women with twin pregnancies and a cervical length (CL) ≤ 28\u2009mm']","['cerclage, pessary, cerclage plus progesterone or pessary plus progesterone', 'cervical cerclage, cervical pessary and vaginal progesterone', 'cervical pessary', 'cervical pessary and cervical cerclage with or without vaginal progesterone', 'cervical cerclage with or without vaginal progesterone']","['preterm birth', 'maternal and neonatal complications', 'rate of PTB']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0152150', 'cui_str': 'Twin pregnancy'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0007874', 'cui_str': 'Cervix uteri structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C4517730', 'cui_str': '340'}]","[{'cui': 'C1292825', 'cui_str': 'Cerclage'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0195681', 'cui_str': 'Cerclage of uterine cervix'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}]","[{'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",340.0,0.402334,The rate of PTB <34 weeks' gestation in women with twin pregnancies and a cervix ≤28 mm and treated with pessary in our previous study at My Duc Hospital was 24.2%.,"[{'ForeName': 'Vinh Q', 'Initials': 'VQ', 'LastName': 'Dang', 'Affiliation': 'Department of Obstetrics and Gynecology, My Duc Hospital, Ho Chi Minh City, Viet Nam bsvinh.dq@myduchospital.vn.'}, {'ForeName': 'Yen Tn', 'Initials': 'YT', 'LastName': 'He', 'Affiliation': 'HOPE Research Center, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Ha Nh', 'Initials': 'HN', 'LastName': 'Pham', 'Affiliation': 'Department of Obstetrics and Gynecology, My Duc Hospital, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Tuyen Tt', 'Initials': 'TT', 'LastName': 'Trieu', 'Affiliation': 'Department of Obstetrics and Gynecology, My Duc Phu Nhuan Hospital, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Trung Q', 'Initials': 'TQ', 'LastName': 'Bui', 'Affiliation': 'Department of Obstetrics and Gynecology, My Duc Hospital, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Nhu T', 'Initials': 'NT', 'LastName': 'Vuong', 'Affiliation': 'Department of Obstetrics and Gynecology, My Duc Hospital, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Loc Mt', 'Initials': 'LM', 'LastName': 'Nguyen', 'Affiliation': 'HOPE Research Center, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Diem Tn', 'Initials': 'DT', 'LastName': 'Nguyen', 'Affiliation': 'HOPE Research Center, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Thanh V', 'Initials': 'TV', 'LastName': 'Le', 'Affiliation': 'Department of Obstetrics and Gynecology, My Duc Hospital, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynecology, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Cam H', 'Initials': 'CH', 'LastName': 'Le', 'Affiliation': 'Department of Obstetrics and Gynecology, My Duc Phu Nhuan Hospital, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Ben W', 'Initials': 'BW', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynecology, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Lan N', 'Initials': 'LN', 'LastName': 'Vuong', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Medicine and Pharmacy at HCMC, Ho Chi Minh City, Viet Nam.'}]",BMJ open,['10.1136/bmjopen-2019-036587']
2827,32554766,Goals-of-care decision aid for critically ill patients with TBI: Development and feasibility testing.,"OBJECTIVE


To develop and demonstrate early feasibility of a goals-of-care decision aid for surrogates of patients who are critically ill with traumatic brain injury (ciTBI) that meets accepted international decision aid guidelines.
METHODS


We developed the decision aid in 4 stages: (1) qualitative study of goals-of-care communication and decision needs of 36 stakeholders of ciTBI (surrogates and physicians), which informed (2) development of paper-based decision aid with iterative revisions after feedback from 52 stakeholders; (3) acceptability and usability testing in 18 neurologic intensive care unit (neuroICU) family members recruited from 2 neuroICU waiting rooms using validated scales; and (4) open-label, randomized controlled feasibility trial in surrogates of ciTBI. We performed an interim analysis of 16 surrogates of 12 consecutive patients who are ciTBI to confirm early feasibility of the study protocol and report recruitment, participation, and retention rates to date.
RESULTS


The resultant goals-of-care decision aid achieved excellent usability (median System Usability Scale 87.5 [possible range 0-100]) and acceptability (97% graded the tool's content as ""good"" or ""excellent""). Early feasibility of the decision aid and the feasibility trial protocol was demonstrated by high rates of recruitment (73% consented), participation (100%), and retention (100% both after the goals-of-care clinician-family meeting and at 3 months) and complete data for the measurements of all secondary decision-related and behavioral outcomes to date.
CONCLUSIONS


Our systematic development process resulted in a novel goals-of-care decision aid for surrogates of patients who are ciTBI with excellent usability, acceptability, and early feasibility in the neuroICU environment, and meets international decision aid standards. This methodology may be a development model for other decision aids in neurology to promote shared decision-making.",2020,"The resultant goals-of-care decision aid achieved excellent usability (median System Usability Scale 87.5 [possible range 0-100]) and acceptability (97% graded the tool's content as ""good"" or ""excellent"").","['18 neurologic intensive care unit (neuroICU) family members recruited from 2 neuroICU waiting rooms using validated scales; and (4) open-label', '16 surrogates of 12 consecutive patients who are ciTBI to confirm early feasibility of the study protocol and report recruitment, participation, and retention rates to date', 'critically ill patients with TBI', 'patients who are critically ill with traumatic brain injury (ciTBI']","['36 stakeholders of ciTBI (surrogates and physicians), which informed (2) development of paper-based decision aid with iterative revisions after feedback from 52 stakeholders; (3) acceptability and usability testing']",['acceptability'],"[{'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0043162', 'cui_str': 'Total body irradiation'}]","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",12.0,0.089653,"The resultant goals-of-care decision aid achieved excellent usability (median System Usability Scale 87.5 [possible range 0-100]) and acceptability (97% graded the tool's content as ""good"" or ""excellent"").","[{'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Muehlschlegel', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA. susanne.muehlschlegel@umassmemorial.org.'}, {'ForeName': 'David Y', 'Initials': 'DY', 'LastName': 'Hwang', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Flahive', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Quinn', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Moskowitz', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Goostrey', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Jones', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Jolanta J', 'Initials': 'JJ', 'LastName': 'Pach', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Andrea K', 'Initials': 'AK', 'LastName': 'Knies', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Shutter', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Goldberg', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Mazor', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}]",Neurology,['10.1212/WNL.0000000000009770']
2828,32554770,Comorbidity is associated with disease activity in MS: Findings from the CombiRx trial.,"OBJECTIVE


To determine whether comorbidity is associated with clinical (relapses, disability worsening) and MRI outcomes in multiple sclerosis (MS), we conducted a secondary analysis of the CombiRx clinical trial.
METHODS


CombiRx compared interferon-beta-1a, glatiramer acetate and the combination of these agents. For participants eligible for evaluation of 6-month confirmed disability worsening, we used medical history, concomitant medications and adverse events to ascertain comorbidity status. Comorbidities evaluated included hypertension, dyslipidemia, diabetes, depression, anxiety disorders, and migraine. Clinical outcomes included disease activity consisting of protocol-defined relapses, disability worsening and MRI activity. We summarized the prevalence of these comorbidities and their association with disease activity and its components using multivariable Cox regression.
RESULTS


Of the 1008 participants randomized, 959 (95.1%) were eligible for assessment of 6-month disability worsening; for this subgroup the median length of follow-up was 3.4 years (range 0.5-6.9 years). Overall, 55.1% of participants had ≥1 comorbidity at enrollment. After adjustment, anxiety (hazard ratio [HR]: 1.25; 95%CI: 1.01-1.55), and dyslipidemia (HR 1.32; 95%CI: 1.01-1.72) were associated with an increased hazard of any disease activity, while migraine (HR 0.80; 95%CI: 0.67-0.96) was associated with a decreased hazard.
CONCLUSIONS


In this large trial population with rigorously obtained outcomes, comorbidities were common among participants and influenced disease outcomes, including relapses. The comorbidity burden of clinical trial participants with MS may be an important factor in the outcome of clinical trials. Additional investigations of the impact of comorbidity on clinical trial outcomes, and response to disease-modifying therapies is warranted.",2020,"After adjustment, anxiety (hazard ratio [HR]: 1.25; 95%CI: 1.01-1.55), and dyslipidemia (HR 1.32; 95%CI: 1.01-1.72) were associated with an increased hazard of any disease activity, while migraine (HR 0.80;","['1008 participants randomized, 959 (95.1%) were eligible for assessment of 6-month disability worsening; for this subgroup the median length of follow-up was 3.4 years (range 0.5-6.9 years', 'multiple sclerosis (MS']","['interferon-beta-1a, glatiramer acetate']","['disease activity consisting of protocol-defined relapses, disability worsening and MRI activity', 'hypertension, dyslipidemia, diabetes, depression, anxiety disorders, and migraine', 'dyslipidemia', 'hazard of any disease activity']","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C4517826', 'cui_str': '6.9'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0254119', 'cui_str': 'Interferon beta-1a'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}]",1008.0,0.179747,"After adjustment, anxiety (hazard ratio [HR]: 1.25; 95%CI: 1.01-1.55), and dyslipidemia (HR 1.32; 95%CI: 1.01-1.72) were associated with an increased hazard of any disease activity, while migraine (HR 0.80;","[{'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Salter', 'Affiliation': 'Department of Biostatistics, Washington University in St. Louis, St. Louis, MO, USA amber@wustl.edu.'}, {'ForeName': 'Kaarina', 'Initials': 'K', 'LastName': 'Kowalec', 'Affiliation': 'College of Pharmacy, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, CAN.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Fitzgerald', 'Affiliation': 'Department of Neurology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Cutter', 'Affiliation': 'Department of Biostatistics, University of Alabama in Birmingham School of Public Health, Birmingham, AL, USA.'}, {'ForeName': 'Ruth Ann', 'Initials': 'RA', 'LastName': 'Marrie', 'Affiliation': 'Departments of Internal Medicine and Community Health Sciences, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, CAN.'}]",Neurology,['10.1212/WNL.0000000000010024']
2829,32554833,Improvement in resilience and stress-related blood markers following ten months yoga practice in Antarctica.,"Background Wintering is associated with distress to humans who work in the isolated and confined environment of Antarctica and yoga has been proved helpful for coping with stress. Therefore, a study was conducted on 14 winter expedition members of Indian Scientific Antarctic Expedition (2016) to find out the effects of yoga on stress-related markers. Methods Participants were divided into yoga, and control (non-yoga) groups. The yoga group practiced yoga for 10 months (from January to October 2016) daily in the morning for an hour. The Resilience test questionnaire was administrated at baseline and endpoint of the study. Blood samples were collected during the study at different intervals for the estimation of 8-hydroxydeoxyguanosine (8-OHdG), brain-derived neurotrophic factor (BDNF), serotonin and cortisol using ELISA. Results A trend of improvement was observed in the resilience test score in the yoga group. From January to October, 8-OHdG serum values in the yoga group declined by 55.9% from 1010.0 ± 67.8 pg/mL to 445.6 ± 60.5 pg/mL (Mean ± SD); in the control group, the decline was 49.9% from 1060.4 ± 54.6 pg/mL to 531.1 ± 81.8 pg/mL. In serotonin serum levels in the yoga group, there was a 3.1% increase from 6.4 ± 1.6 ng/mL to 6.6 ± 0.4 ng/mL while no increase was noticed in the control group. Cortisol values in the yoga group decreased by 19.9% from 321.0 ± 189.6 ng/mL to 257.1 ± 133.8 ng/mL; in the control group it increased by 2.8% from 241.2 ± 51.8 ng/mL to 247.8 ± 90.9 ng/mL. Conclusions It could be concluded from the present study that following 10 months yoga practice may be useful for better resilience and management of stress-related blood markers for the polar sojourners.",2020,"From January to October, 8-OHdG serum values in the yoga group declined by 55.9% from 1010.0 ± 67.8 pg/mL to 445.6 ± 60.5 pg/mL (Mean ± SD); in the control group, the decline was 49.9% from 1060.4 ± 54.6 pg/mL to 531.1 ± 81.8 pg/mL.","['14 winter expedition members of Indian Scientific Antarctic Expedition (2016', '51.8', '189.6', '133.8']",['yoga group practiced yoga'],"['Cortisol values', '8-OHdG serum values', 'serotonin serum levels', '8-hydroxydeoxyguanosine (8-OHdG), brain-derived neurotrophic factor (BDNF), serotonin and cortisol using ELISA', 'resilience and stress-related blood markers', 'resilience test score']","[{'cui': 'C0015315', 'cui_str': 'Expeditions'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0454691', 'cui_str': 'Antarctica'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0018262', 'cui_str': 'Group Practice'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0050078', 'cui_str': '8-hydroxy-deoxyguanosine'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0297412,"From January to October, 8-OHdG serum values in the yoga group declined by 55.9% from 1010.0 ± 67.8 pg/mL to 445.6 ± 60.5 pg/mL (Mean ± SD); in the control group, the decline was 49.9% from 1060.4 ± 54.6 pg/mL to 531.1 ± 81.8 pg/mL.","[{'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Nirwan', 'Affiliation': 'Defence Institute of Physiology & Allied Sciences (DIPAS) Defence R & D Organization Timarpur, Delhi, India.'}, {'ForeName': 'Kaushik', 'Initials': 'K', 'LastName': 'Halder', 'Affiliation': 'Defence Institute of Physiology & Allied Sciences (DIPAS) Defence R & D Organization Timarpur, Delhi, India.'}, {'ForeName': 'Mantu', 'Initials': 'M', 'LastName': 'Saha', 'Affiliation': 'Defence Institute of Physiology & Allied Sciences (DIPAS) Defence R & D Organization Timarpur, Delhi-110054, India.'}, {'ForeName': 'Anjana', 'Initials': 'A', 'LastName': 'Pathak', 'Affiliation': 'Defence Institute of Physiology & Allied Sciences (DIPAS) Defence R & D Organization Timarpur, Delhi, India.'}, {'ForeName': 'Ragavendrasamy', 'Initials': 'R', 'LastName': 'Balakrishnan', 'Affiliation': 'Swami Vivekananda Yoga Anusandhana (S-VYASA), Bengaluru, Karnataka, India.'}, {'ForeName': 'Lilly', 'Initials': 'L', 'LastName': 'Ganju', 'Affiliation': 'Defence Institute of Physiology & Allied Sciences (DIPAS) Defence R & D Organization Timarpur, Delhi, India.'}]",Journal of complementary & integrative medicine,['10.1515/jcim-2019-0240']
2830,32554837,Efficacy of Qurs-e-Gulnar in Ziabetus (type 2 Diabetes Mellitus): a single blind randomized controlled trial.,"Background and objectives Diabetes is a serious threat to global health that respects neither socioeconomic status nor national boundaries. Globally, diabetes is among the top 10 causes of death. Unani system argued the effectiveness of several anti-hyperglycemic drugs, and all such drugs looked-for to be validated on scientifically. Hence a clinical trial was contemplated to evaluate the clinical efficacy of Qurs-e-Gulnar in the management of Diabetes Mellitus. Methods This study was conducted as single blind randomized control, on 40 patients of type 2 diabetes with the test (n=20) and control (n=20) groups for 45 days. Test group received Qurs-e-Gulnar at the dose of three Qurs twice a day, and control group received two capsules Diabeat® twice a day before meal. Subjective (at 0, 15th, 30th, and 45th) and objective parameters were assessed as pre-post treatment respectively. Results After treatment with test compound significant reduction was observed in all the subjective parameters viz. polyuria, polydipsia, polyphagia and tiredness in comparison of control group. The objective parameters FBS and PPBS was found to be significantly reduced (p<0.001) in both the groups where as HbA1c was found unchanged in test group but control drug showed highly significant reduction in HbA1c (p<0.001).The results were assessed statistically using two tailed Student's t-test, and Fischer exact test. Conclusion On the basis of above observation it is concluded that the test compound Qurs-e-Gulnar has significant anti-diabetic effect which is evidentially observed both in subjective and objective parameters in test group in comparison of control group (CTRI/2017/07/009060).",2020,"The objective parameters FBS and PPBS was found to be significantly reduced (p<0.001) in both the groups where as HbA1c was found unchanged in test group but control drug showed highly significant reduction in HbA1c (p<0.001).The results were assessed statistically using two tailed Student's t-test, and Fischer exact test.","['40 patients of type 2 diabetes with the test (n=20) and control (n=20) groups for 45\xa0days', 'Ziabetus (type 2 Diabetes Mellitus', 'Diabetes Mellitus']",['Qurs-e-Gulnar'],"['objective parameters FBS and PPBS', 'polyuria, polydipsia, polyphagia and tiredness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]",[],"[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3495427', 'cui_str': 'Fanconi-Bickel Syndrome'}, {'cui': 'C0032617', 'cui_str': 'Polyuria'}, {'cui': 'C0085602', 'cui_str': 'Excessive thirst'}, {'cui': 'C0020505', 'cui_str': 'Overeating'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.0328326,"The objective parameters FBS and PPBS was found to be significantly reduced (p<0.001) in both the groups where as HbA1c was found unchanged in test group but control drug showed highly significant reduction in HbA1c (p<0.001).The results were assessed statistically using two tailed Student's t-test, and Fischer exact test.","[{'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Eqbal', 'Affiliation': 'Department of Moalajat, Sufiya Unani Medical College Hospital and Research Centre, Bara Chakia East Champaran, Bihar, India.'}, {'ForeName': 'Md Anzar', 'Initials': 'MA', 'LastName': 'Alam', 'Affiliation': 'Department of Moalajat, National Institute of Unani Medicine, Bangalore, India.'}, {'ForeName': 'Mohd Aleemuddin', 'Initials': 'MA', 'LastName': 'Quamri', 'Affiliation': 'Department of Moalajat, National Institute of Unani Medicine, Bangalore, India.'}, {'ForeName': 'Ghulamuddin', 'Initials': 'G', 'LastName': 'Sofi', 'Affiliation': 'Department of Ilmul Advia, NIUM, Bangalore, India.'}, {'ForeName': 'Muzafar Din', 'Initials': 'MD', 'LastName': 'Ahmad Bhat', 'Affiliation': 'Department of Moalajat, National Institute of Unani Medicine, Bangalore, India.'}]",Journal of complementary & integrative medicine,['10.1515/jcim-2020-0072']
2831,32554843,Effects of whole-body electromyostimulation exercise and caloric restriction on cardiometabolic risk profile and muscle strength in obese women with the metabolic syndrome: a pilot study.,"Obesity, particularly in conjunction with further cardiometabolic risk factors, is associated with an increased risk of cardiovascular disease and mortality. Increased physical activity and dietary modifications are cornerstones of therapeutic interventions to treat obesity and related risk factors. Whole-body electromyostimulation (WB-EMS) has emerged as an innovative, time-efficient type of exercise that can provide positive effects on body composition and muscle strength. However, the impact of WB-EMS on cardiometabolic health in obese individuals with metabolic syndrome (MetS) has yet to be determined. The aim of this pilot study was, therefore, to investigate the feasibility and effects of WB-EMS on cardiometabolic risk markers and muscle strength in obese women diagnosed with MetS. Twenty-nine obese women (56.0 ± 10.9 years, BMI: 36.7 ± 4.6 kg/m 2 ) with the clinical diagnosis of MetS were randomized to either 12 weeks of WB-EMS (n = 15) or an inactive control group (CON, n = 14). Both groups received nutritional counseling (aim: -500 kcal energy deficit/day). WB-EMS was performed 2x/week (20 min/session). Body composition, maximum strength (F max ) of major muscle groups, selected cardiometabolic risk indices and the metabolic syndrome Z-score (MetS-Z) were determined baseline and after the intervention. WB-EMS was well tolerated and no adverse events occurred. Body weight was significantly reduced in both groups by an average of ~3 kg (P < 0.01). The body fat percentage was only decreased in the WB-EMS group (P = 0.018). Total cholesterol concentrations decreased in the WB-EMS group (P = 0.018) and in CON (P = 0.027). Only the WB-EMS group increased F max  significantly in all major muscle groups (P < 0.05) and improved the overall cardiometabolic risk score (MetS-Z, P = 0.029). This pilot study indicates that WB-EMS can be considered as a feasible and time-efficient exercise option for improving body composition, muscle strength and cardiometabolic health in obese women with MetS. Moreover, these findings underpin the crucial role of exercise during weight loss interventions in improving health outcomes.",2020,Total cholesterol concentrations decreased in the WB-EMS group (P = 0.018) and in CON (P = 0.027).,"['obese individuals with metabolic syndrome (MetS', 'obese women with the metabolic syndrome', 'obese women diagnosed with MetS. Twenty-nine obese women (56.0 ± 10.9 years, BMI: 36.7 ± 4.6 kg/m 2 ) with the clinical diagnosis of MetS', 'obese women with MetS']","['whole-body electromyostimulation exercise and caloric restriction', 'WB-EMS', 'nutritional counseling']","['cardiometabolic health', 'cardiometabolic risk profile and muscle strength', 'body fat percentage', 'overall cardiometabolic risk score', 'body composition, muscle strength and cardiometabolic health', 'Body weight', 'F max', 'Body composition, maximum strength (F max ) of major muscle groups, selected cardiometabolic risk indices and the metabolic syndrome Z-score (MetS-Z', 'Total cholesterol concentrations', 'tolerated and no adverse events', 'cardiometabolic risk markers and muscle strength']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1963761', 'cui_str': 'No adverse event'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",29.0,0.0249195,Total cholesterol concentrations decreased in the WB-EMS group (P = 0.018) and in CON (P = 0.027).,"[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Reljic', 'Affiliation': 'Hector-Center for Nutrition, Exercise and Sports, Department of Medicine 1, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuernberg, Erlangen, Germany. dejan.reljic@uk-erlangen.de.'}, {'ForeName': 'P C', 'Initials': 'PC', 'LastName': 'Konturek', 'Affiliation': 'Second Department of Medicine, Thuringia-Clinic Saalfeld, Saalfeld/Saale, Germany.'}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Herrmann', 'Affiliation': 'Hector-Center for Nutrition, Exercise and Sports, Department of Medicine 1, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuernberg, Erlangen, Germany.'}, {'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Neurath', 'Affiliation': 'Department of Medicine 1, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuernberg, Erlangen, Germany.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zopf', 'Affiliation': 'Hector-Center for Nutrition, Exercise and Sports, Department of Medicine 1, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuernberg, Erlangen, Germany.'}]",Journal of physiology and pharmacology : an official journal of the Polish Physiological Society,['10.26402/jpp.2020.1.08']
2832,32554911,Effect of photobiomodulation on pain perception among orthodontic patients: a randomized clinical trial.,,2020,,['orthodontic patients'],['photobiomodulation'],['pain perception'],"[{'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",,0.215888,,"[{'ForeName': 'Nour', 'Initials': 'N', 'LastName': 'Al-Okla', 'Affiliation': 'Private Practice of Orthodontics in Dubai, United Arab Emarites.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Bader', 'Affiliation': 'Private Practice of Orthodontics in Riyadh, Saudi Arabia.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Al-Mulla', 'Affiliation': 'Orthodontic Consultant, Riyadh, Saudi Arabia.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Ferguson', 'Affiliation': 'European University College, Dubai, United Arab Emirates.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Shaughnessy', 'Affiliation': 'Private Practice of Orthodontics, Marietta, GA. str8tth@me.com.'}]",Journal of clinical orthodontics : JCO,[]
2833,32554999,Hip Resurfacing Compared with 28-mm Metal-on-Metal Total Hip Replacement: A Randomized Study with 15 Years of Follow-up.,"BACKGROUND


Bone stock conservation, hip anatomy preservation, and greater stability are among the promoted advantages of hip resurfacing (HR). However, the disappointing failure of some implants nearly led to its abandonment. The aim of this study was to compare clinical scores and revision and complication rates after HR with those after total hip arthroplasty (THA).
METHODS


Two hundred and three hips were randomized to 28-mm metal-on-metal (MoM) THA (99 hips) or to HR (104 hips). Main outcome measures compared between groups were the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, the revision rate, and the complication rates. The radiographic findings were also assessed.
RESULTS


After a mean follow-up of 15 years (range, 14 to 16 years), 9 (4.4%) of the 203 patients were lost to follow-up and 15 (7.4%) had died. The Kaplan-Meier survivorship, with revision for any reason as the end point, was 89.2% (95% confidence interval [CI], 82.3% to 96.1%) for HR and 94.2% (95% CI, 89.3% to 99.1%) for THA (p = 0.292). The reasons for revision included infection (3 patients), recurrent dislocation (1 patient), and adverse reaction to metal debris (ARMD) (1 patient) in the THA group and ARMD (2 patients) and femoral head loosening (7 patients) in the HR group. With aseptic revision as the end point, the Kaplan-Meier survivorship was significantly higher in the THA group (97.4% versus 89.2%; p = 0.033). No dislocation occurred in the HR group compared with 4 in the THA group (p = 0.058). Both groups achieved a similar mean WOMAC score (10.7 in the HR group and 8.8 in the THA group; p = 0.749), Forgotten Joint Score (87.1 and 85.3, respectively; p = 0.410), University of California Los Angeles (UCLA) activity score (6.3 and 6.4, respectively; p = 0.189), and overall joint perception (p = 0.251).
CONCLUSIONS


The specific HR and MoM 28-mm THA implants used in this study showed good long-term survival and function. The overall rates of complications and revisions were similar in both groups but were of different types. As it provides better femoral bone preservation and biomechanical reconstruction, HR may continue to have a role in selected patients when performed by experienced surgeons and using validated implants.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"With aseptic revision as the end point, the Kaplan-Meier survivorship was significantly higher in the THA group (97.4% versus 89.2%; p = 0.033).","['Two hundred and three hips', '15 Years of Follow-up']","['THA', '28-mm metal-on-metal (MoM', '28-mm Metal-on-Metal Total Hip Replacement', 'Hip Resurfacing', 'total hip arthroplasty (THA']","['University of California Los Angeles (UCLA) activity score', 'overall rates of complications and revisions', 'mean WOMAC score', 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, the revision rate, and the complication rates', 'recurrent dislocation (1 patient), and adverse reaction to metal debris (ARMD', 'Kaplan-Meier survivorship', 'clinical scores and revision and complication rates', 'died', 'good long-term survival and function', 'overall joint perception', 'Forgotten Joint Score', 'No dislocation']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}]","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0158100', 'cui_str': 'Recurrent dislocation of joint'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0440266', 'cui_str': 'Debris'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C4759288', 'cui_str': 'Forgotten Joint Score'}, {'cui': 'C0012691', 'cui_str': 'Dislocation'}]",203.0,0.128028,"With aseptic revision as the end point, the Kaplan-Meier survivorship was significantly higher in the THA group (97.4% versus 89.2%; p = 0.033).","[{'ForeName': 'Pascal-André', 'Initials': 'PA', 'LastName': 'Vendittoli', 'Affiliation': 'Surgery Department, Hôpital Maisonneuve-Rosemont, Montreal University, Montréal, Québec, Canada.'}, {'ForeName': 'Maged', 'Initials': 'M', 'LastName': 'Shahin', 'Affiliation': 'Surgery Department, Hôpital Maisonneuve-Rosemont, Montreal University, Montréal, Québec, Canada.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Rivière', 'Affiliation': 'MSK Lab-Imperial College London, London, United Kingdom.'}, {'ForeName': 'Alain Guy', 'Initials': 'AG', 'LastName': 'Roy', 'Affiliation': 'Surgery Department, Hôpital Maisonneuve-Rosemont, Montreal University, Montréal, Québec, Canada.'}, {'ForeName': 'Janie', 'Initials': 'J', 'LastName': 'Barry', 'Affiliation': 'Surgery Department, Hôpital Maisonneuve-Rosemont, Montreal University, Montréal, Québec, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lavigne', 'Affiliation': 'Surgery Department, Hôpital Maisonneuve-Rosemont, Montreal University, Montréal, Québec, Canada.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.20.00030']
2834,32555011,Effect of Tactile Experience During Preterm Infant Feeding on Clinical Outcomes.,"BACKGROUND


Although the survival rate of very preterm infants has improved, rates of subsequent neurobehavioral disabilities remains high. One factor implicated in poor neurobehavioral and developmental outcomes is hospitalization and inconsistent caregiving patterns in the neonatal intensive care unit. Although much underlying brain damage occurs in utero or shortly after birth, neuroprotective strategies may stop progression of damage, particularly when these strategies are used during the most sensitive periods of neural plasticity two to three months before term age.
OBJECTIVE


The purpose of this analysis was to test the effect of a patterned feeding experience involving a tactile component (touch and/or holding) provided during feedings on preterm infants' clinical outcomes, measured by oral feeding progress, as an early indicator of neurodevelopment.
METHODS


We used an experimental, longitudinal, 2-group random assignment design. Preterm infants (n = 120) were enrolled within the first week of life and randomized to an experimental group receiving a patterned feeding experience or to a control group receiving usual feeding care.
RESULTS


Analysis of data from 91 infants showed that infants receiving touch at more than 25% of early gavage feedings achieved full oral feeding more quickly; as touch exposure increased, time from first oral to full oral feeding decreased. There was no association between holding during early gavage feedings or touch during transition feedings and time to full oral feeding.
DISCUSSION


Neurological expectation during critical periods of development is important for infants. However, a preterm infant's environment is not predictable: caregivers change regularly, medical procedures dictate touch and holding, and care provision based on infant cues is limited. Current knowledge supports caregiving that occurs with a naturally occurring sensation (i.e., hunger), is provided in a manner that is congruent with the expectation of the neurological system, and that occurs with enough regularity to enhance neuronal and synaptic development. In this study, we modeled an experience infants would ""expect"" if they were not in the neonatal intensive care unit and demonstrated a shorter time from first oral feeding to full oral feeding, an important clinical outcome with neurodevelopmental implications. We recommend further research to determine the effect of patterned caregiving experiences on other areas of neurodevelopment, particularly those that may occur later in life.",2020,"There was no association between holding during early gavage feedings or touch during transition feedings and time to full oral feeding.
",['Preterm infants (n = 120'],"['experimental group receiving a patterned feeding experience or to a control group receiving usual feeding care', 'Tactile Experience', 'patterned feeding experience involving a tactile component (touch and/or holding']",['survival rate'],"[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0152054', 'cui_str': 'Touch'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",120.0,0.0399053,"There was no association between holding during early gavage feedings or touch during transition feedings and time to full oral feeding.
","[{'ForeName': 'Rita H', 'Initials': 'RH', 'LastName': 'Pickler', 'Affiliation': ""The Ohio State University, Columbus, OH Cincinnati Children's Hospital Medical Center and University of Cincinnati, Cincinnati, OH Cincinnati Children's Hospital Medical Center, Cincinnati, OH The Ohio State University, Columbus, OH Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Jareen', 'Initials': 'J', 'LastName': 'Meinzen-Derr', 'Affiliation': ''}, {'ForeName': 'Margo', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Sealschott', 'Affiliation': ''}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Tepe', 'Affiliation': ''}]",Nursing research,['10.1097/NNR.0000000000000453']
2835,32555024,Metabolic Impact of Breaking Up Prolonged Sitting with Stair Climbing Exercise Snacks.,"PURPOSE


Prolonged sitting is associated with cardiometabolic complications. The study purpose was to investigate whether breaking up prolonged sitting with brief stair climbing exercise ""snacks"" could lower postprandial insulin, glucose and free fatty acids responses.
METHODS


In two separate randomized crossover studies, 12 young healthy weight (HW) men (Study 1) and 11 adults with overweight/obesity (OW) (Study 2) completed two experimental conditions: i) Sedentary (SED; 9h sitting) and ii) stair climbing snacks (SS; 8 X 15-30 seconds once per hour). The same high-glycemic index meals were consumed at 0, 3 and 6 h at each condition. The primary outcome was total insulin area under the curve (AUC) across 9 h.
RESULTS


In HW men, there were no significant differences between SS and SED for total (9-h) insulin AUC (P=0.24, d=0.4), total glucose AUC (P = 0.17, d = 0.48), total NEFA AUC (P = 0.22, d = 0.4), or total triglyceride (TG) AUC (P = 0.72). In adults with OW, total insulin AUC (-16.5%, P=0.036, d=0.94) and total NEFA AUC (-21%, P = 0.016, d = 1.2) were significantly lower in SS vs. SED. No differences were found for total glucose and TG AUCs (all P > 0.31) in participants with OW.
CONCLUSION


Breaking up nine hours of prolonged sitting with hourly brief stair climbing exercise snacks lowered postprandial insulin and NEFA levels in adults with overweight/obesity.",2020,"No differences were found for total glucose and TG AUCs (all P > 0.31) in participants with OW.
","['12 young healthy weight (HW) men (Study 1) and 11 adults with overweight/obesity (OW) (Study 2) completed two', 'adults with overweight/obesity']","['experimental conditions: i) Sedentary (SED; 9h sitting) and ii) stair climbing snacks (SS', 'Breaking Up Prolonged Sitting with Stair Climbing Exercise Snacks', 'stair climbing exercise snacks', 'breaking up prolonged sitting with brief stair climbing exercise ""snacks']","['total glucose and TG AUCs', 'total triglyceride (TG) AUC', 'postprandial insulin, glucose and free fatty acids responses', 'postprandial insulin and NEFA levels', 'SS and SED for total (9-h) insulin AUC', 'total insulin area under the curve (AUC', 'total NEFA AUC', 'total glucose AUC', 'total insulin AUC']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C1290942', 'cui_str': 'Climbing stairs'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",12.0,0.0289951,"No differences were found for total glucose and TG AUCs (all P > 0.31) in participants with OW.
","[{'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Rafiei', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Okanagan Campus, Kelowna, British Columbia, Canada.'}, {'ForeName': 'Kosar', 'Initials': 'K', 'LastName': 'Omidian', 'Affiliation': 'College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'Étienne', 'Initials': 'É', 'LastName': 'Myette-Côté', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Okanagan Campus, Kelowna, British Columbia, Canada.'}, {'ForeName': 'Jonathan Peter', 'Initials': 'JP', 'LastName': 'Little', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Okanagan Campus, Kelowna, British Columbia, Canada.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002431']
2836,32553836,Early Weight Gain Forecasts Accelerated Eruption of Deciduous Teeth and Later Overweight Status during the First Year.,"OBJECTIVES


To determine whether early diet and weight gain velocity have independent or interactive effects on deciduous teeth emergence and overweight status during the first year.
STUDY DESIGN


Monthly measures of anthropometry and teeth eruption were collected during 1-year trial (0.5-12.5 months) on formula-fed (FF) infants in which the type of randomized infant formula (cow milk or extensively hydrolyzed protein) diet significantly affected early (0.5-4.5 months) weight gain velocity. Generalized linear mixed models determined whether early diet and weight gain velocity had independent or interactive effects on timing and pattern of teeth eruption. Data from a trial on breastfed (BF) infants were used to explore effects of breast milk versus infant formula diets on teeth eruption and overweight status at 10.5 months.
RESULTS


Independent of infant formula diet, velocities of weight gain had direct effects on the age of first deciduous tooth (P < .04) and number of erupted teeth over time (P<0.002). Greater velocity of weight gain from 0.5 to 4.5 months caused earlier and more frequent eruption of deciduous teeth from 4.5 to 12.5 months. Exploratory follow-up analyses on the BF and FF diet groups found early weight gain velocity (P=0.001), but not diet or its interaction, had significant effects. Infants in the upper quartile for weight gain velocity had more primary teeth (P=0.002), and a greater proportion of them were overweight (P<0.001) at 10.5 months.
CONCLUSIONS


Faster weight gain accretion forecasted accelerated primary teeth eruption and increased percentage of children who were overweight-risk factors for dental caries and obesity.",2020,"Exploratory follow-up analyses on the BF and FF diet groups found early weight gain velocity (P=0.001), but not diet or its interaction, had significant effects.",[],"['formula-fed (FF) infants in which the type of randomized infant formula (cow milk or extensively hydrolyzed protein) diet', 'breast milk versus infant formula diets']","['Greater velocity of weight gain', 'frequent eruption of deciduous teeth', 'weight gain velocity', 'teeth eruption and overweight status']",[],"[{'cui': 'C0342895', 'cui_str': 'Fish-eye disease'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0150589', 'cui_str': 'Infant formula'}, {'cui': 'C0349374', 'cui_str': ""Cow's milk""}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0026131', 'cui_str': 'Milk'}]","[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}, {'cui': 'C0040437', 'cui_str': 'Tooth erupted'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.0416378,"Exploratory follow-up analyses on the BF and FF diet groups found early weight gain velocity (P=0.001), but not diet or its interaction, had significant effects.","[{'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Mennella', 'Affiliation': 'Monell Chemical Senses Center, Philadelphia, PA. Electronic address: mennella@monell.org.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Reiter', 'Affiliation': 'Monell Chemical Senses Center, Philadelphia, PA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Brewer', 'Affiliation': 'University of Delaware, Newark, DE.'}, {'ForeName': 'Ryan T', 'Initials': 'RT', 'LastName': 'Pohlig', 'Affiliation': 'University of Delaware, Newark, DE.'}, {'ForeName': 'Virginia A', 'Initials': 'VA', 'LastName': 'Stallings', 'Affiliation': ""Children's Hospital of Philadelphia, Division of Gastroenterology, Hepatology and Nutrition, Philadelphia, PA.""}, {'ForeName': 'Jillian C', 'Initials': 'JC', 'LastName': 'Trabulsi', 'Affiliation': 'University of Delaware, Newark, DE.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.06.019']
2837,32553868,"Synthetic Surfactant CHF5633 compared with Poractant Alfa in the Treatment of Neonatal Respiratory Distress Syndrome: A Multicenter, Double Blind, Randomized, Controlled Clinical Trial.","OBJECTIVE


To compare efficacy and safety of a new synthetic surfactant, CHF5633, enriched with surfactant proteins, SP-B and SP-C peptide analogues, with porcine surfactant, poractant alfa for the treatment of respiratory distress syndrome (RDS) in preterm infants.
STUDY DESIGN


Preterm neonates on respiratory support requiring fraction of inspired oxygen (FiO 2 ) ≥0.30 from 24 0/7  to 26 6/7  weeks and FiO 2  ≥0.35 from 27 0/7  to 29 6/7  weeks gestation to maintain 88-95% oxygen saturation were randomized to receive 200 mg/kg of CHF5633 or PA. If necessary, redosing was given at 100 mg/kg. Efficacy endpoints were oxygen requirement [FiO 2 , Respiratory Severity Score (RSS) (FiO 2  x mean airway pressure)] in the first 24 h, 7 and 28 days, discharge home and/or 36-week postmenstrual age, mortality and bronchopulmonary dysplasia (BPD) at 28 days and 36-week PMA. Adverse events and immunogenicity were monitored for safety.
RESULTS


Of the 123 randomized neonates, 113 were treated (56 and 57 in CHF5633 and PA groups, respectively). In both arms FiO 2  and RSS decreased from baseline at all timepoints (P < .001) with no statistically significant differences between groups. Rescue surfactant use [19 (33.9%) vs 17 (29.8%)], BPD [31 (55.4%) and 32 (56.1%)], and mortality at Day 28 [4 (7.1%) and 3 (5.3%)] were similar in the CHF5633 and PA groups, respectively. In 2 (3.4%) and 1 (1.7%) neonates, adverse drug reactions were reported in CHF5633 and PA groups, respectively. No immunogenicity was detected.
CONCLUSION


Treatment with CHF5633 showed similar efficacy and safety as PA in preterm neonates with moderate to severe RDS.",2020,In both arms FiO 2  and RSS decreased from baseline at all timepoints (P < .001) with no statistically significant differences between groups.,"['Preterm neonates on respiratory support requiring fraction of inspired oxygen (FiO 2 ', 'respiratory distress syndrome (RDS) in preterm infants', '123 randomized neonates', 'preterm neonates with moderate to severe RDS', '≥0.30 from 24 0/7  to 26 6/7  weeks and FiO 2  ≥0.35 from 27 0/7  to 29 6/7  weeks gestation to maintain 88-95% oxygen saturation', 'Neonatal Respiratory Distress Syndrome']","['CHF5633 or PA', 'Poractant Alfa', 'CHF5633', 'Synthetic Surfactant CHF5633', 'new synthetic surfactant, CHF5633, enriched with surfactant proteins, SP-B and SP-C peptide analogues, with porcine surfactant, poractant alfa']","['BPD', 'adverse drug reactions', 'discharge home and/or 36-week postmenstrual age, mortality and bronchopulmonary dysplasia (BPD', 'efficacy and safety', 'mortality', 'Adverse events and immunogenicity', 'RSS', 'oxygen requirement [FiO 2 , Respiratory Severity Score (RSS) (FiO 2  x mean airway pressure']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}]","[{'cui': 'C3885750', 'cui_str': 'CHF5633'}, {'cui': 'C0771648', 'cui_str': 'Poractant alfa'}, {'cui': 'C0038891', 'cui_str': 'Surfactant'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3544277', 'cui_str': 'Surfactant protein'}, {'cui': 'C0630744', 'cui_str': 'substance P, cyclo(H-Glu-Phe-Phe-Gly-Leu-Met-NH(CH2)3-NH-)'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}]","[{'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0175693', 'cui_str': 'Russell-Silver syndrome'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}]",,0.338415,In both arms FiO 2  and RSS decreased from baseline at all timepoints (P < .001) with no statistically significant differences between groups.,"[{'ForeName': 'Rangasamy', 'Initials': 'R', 'LastName': 'Ramanathan', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, LAC+USC Medical Center and Good Samaritan Hospital, Keck School of Medicine of USC, Los Angeles, CA, United States. Electronic address: ramanath@usc.edu.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Biniwale', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, LAC+USC Medical Center and Good Samaritan Hospital, Keck School of Medicine of USC, Los Angeles, CA, United States.'}, {'ForeName': 'Krishnamurthy', 'Initials': 'K', 'LastName': 'Sekar', 'Affiliation': ""Department of Pediatrics, Division of Neonatology, Oklahoma University Medical Center, Children's Hospital, University of Oklahoma Health Sciences Center, OK, United States.""}, {'ForeName': 'Nazeeh', 'Initials': 'N', 'LastName': 'Hanna', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, NYU Winthrop Hospital, NYU Long Island School of Medicine, NY, United States.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Golombek', 'Affiliation': ""Department of Pediatrics, Division of Neonatology, Joseph M. Sanzari Children's Hospital at Hackensack University Medical Center, New Jersey, United States.""}, {'ForeName': 'Jatinder', 'Initials': 'J', 'LastName': 'Bhatia', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, The Medical College of Georgia at Augusta University, Augusta, GA, United States.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Naylor', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, Brody School of Medicine at East Carolina University, Greenville, NC, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Fabbri', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Varoli', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy.'}, {'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Santoro', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy.'}, {'ForeName': 'Dorothea', 'Initials': 'D', 'LastName': 'Del Buono', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Piccinno', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy.'}, {'ForeName': 'Christiane E', 'Initials': 'CE', 'LastName': 'Dammann', 'Affiliation': 'Deaprtment of Pediatrics, Division of Neonatology, Floating Hospital for Children at Tufts Medical Center, Boston, MA, United States.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.06.024']
2838,32556113,"A Phase 3, Randomised, Open-Label, Non-inferiority Trial Evaluating Anti-Rabies Monoclonal Antibody Cocktail (TwinrabTM) Against Human Rabies Immunoglobulin (HRIG).","BACKGROUND


Limited supply, cost and potential for severe adverse effects observed with the blood derived rabies immunoglobulin products has led to search for alternative therapies. This issue has been addressed by developing an antirabies monoclonal antibody cocktail.
METHODS


This is a phase 3, randomized, open-label, noninferiority trial conducted in patients with WHO category III exposure with suspected rabid animal. Eligible patients were assigned to either the test arm, TwinrabTM (docaravimab and miromavimab) or the reference arm, Human rabies immunoglobulin (HRIG; Imogam® Rabies-HT), in a ratio of 1:1. The primary endpoint was the comparison of responder rates between the two arms assessed as percentage of those with rabies virus neutralizing antibodies titers ≥ 0.5 IU/mL on day 14.
RESULTS


A total of 308 patients were equally randomized into the two arms. In the per-protocol (PP) population, there were 90.21% responders in the TwinrabTM arm and, 94.37% in the HRIG arm. The Geometric Mean of RFFIT titres in the PP on day 14 were 4.38 and 4.85 IU/mL, for the TwinrabTM and HRIG arms, respectively. There were no deaths or serious adverse events reported.
CONCLUSIONS


This study confirmed that TwinrabTM is non-inferior to HRIG in terms of providing an unbroken window of protection up to day 84. This trial in healthy adults with WHO category III exposure from suspected rabid animal also establishes the safety of TwinrabTM in patients with one WHO approved vaccine regimen (Essen).
TRIALS REGISTRATION


CTRI/2017/07/009038.",2020,"There were no deaths or serious adverse events reported.
","['patients with WHO category III exposure with suspected rabid animal', 'A total of 308 patients', 'patients with one WHO approved vaccine regimen (Essen', 'healthy adults with WHO category III exposure from suspected rabid animal']","['TwinrabTM', 'Anti-Rabies Monoclonal Antibody Cocktail (TwinrabTM', 'Against Human Rabies Immunoglobulin (HRIG', 'TwinrabTM (docaravimab and miromavimab) or the reference arm, Human rabies immunoglobulin (HRIG; Imogam® Rabies-HT']","['deaths or serious adverse events', 'Geometric Mean of RFFIT titres', 'comparison of responder rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C0678420', 'cui_str': 'Cocktail'}, {'cui': 'C1321098', 'cui_str': 'Human rabies'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4026551', 'cui_str': 'Imogam'}, {'cui': 'C0034494', 'cui_str': 'Rabies'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}]",308.0,0.167448,"There were no deaths or serious adverse events reported.
","[{'ForeName': 'Kevinkumar', 'Initials': 'K', 'LastName': 'Kansagra', 'Affiliation': 'Clinical R & D, Cadila Healthcare Limited, India.'}, {'ForeName': 'Deven', 'Initials': 'D', 'LastName': 'Parmar', 'Affiliation': 'Zydus Discovery DMCC, Dubai.'}, {'ForeName': 'Sanjeev Kumar', 'Initials': 'SK', 'LastName': 'Mendiratta', 'Affiliation': 'Biologics R&D and Mfg, Cadila Healthcare Limited, India.'}, {'ForeName': 'Jatin', 'Initials': 'J', 'LastName': 'Patel', 'Affiliation': 'Clinical R & D, Cadila Healthcare Limited, India.'}, {'ForeName': 'Shuchi', 'Initials': 'S', 'LastName': 'Joshi', 'Affiliation': 'Clinical R & D, Cadila Healthcare Limited, India.'}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Sharma', 'Affiliation': 'Clinical R & D, Cadila Healthcare Limited, India.'}, {'ForeName': 'Anurag', 'Initials': 'A', 'LastName': 'Parihar', 'Affiliation': 'Clinical R & D, Cadila Healthcare Limited, India.'}, {'ForeName': 'Swapnil', 'Initials': 'S', 'LastName': 'Bhoge', 'Affiliation': 'Clinical R & D, Cadila Healthcare Limited, India.'}, {'ForeName': 'Harilal', 'Initials': 'H', 'LastName': 'Patel', 'Affiliation': 'Drug metabolism and pharmacokinetic, Cadila Healthcare Limited, India.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Kalita', 'Affiliation': 'Biotechnology, Cadila Healthcare Limited, India.'}, {'ForeName': 'Renuka', 'Initials': 'R', 'LastName': 'Munshi', 'Affiliation': 'TN Medical College and BYL Nair Charitable Hospital, Mumbai.'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Kurmi', 'Affiliation': 'Shivam Hospital, Ahmedabad.'}, {'ForeName': 'Ruchir', 'Initials': 'R', 'LastName': 'Shah', 'Affiliation': 'Medistar Hospital, Himatnagar.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Subharti Medical College, Meerut.'}, {'ForeName': 'HiraLal', 'Initials': 'H', 'LastName': 'Bhalla', 'Affiliation': 'Subharti Medical College, Meerut.'}, {'ForeName': 'Harish', 'Initials': 'H', 'LastName': 'Bekkalele', 'Affiliation': 'Mandya Institute of Medical Science, Mandya.'}, {'ForeName': 'RajendraKumar', 'Initials': 'R', 'LastName': 'Verma', 'Affiliation': 'GSVM Medical College, Kanpur.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Agarwal', 'Affiliation': 'Marwari Hospital and Research Centre, Guwahati.'}, {'ForeName': 'Shrikant', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'SMS Medical College, Jaipur.'}, {'ForeName': 'Avinash', 'Initials': 'A', 'LastName': 'Gawande', 'Affiliation': 'Government Medical College, Nagpur.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Chhaya', 'Affiliation': 'Saviour Hospital, Ahmedabad.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa779']
2839,32556204,"Emulsion Droplet Crystallinity Attenuates Short-Term Satiety in Healthy Adult Males: A Randomized, Double-Blinded, Crossover, Acute Meal Study.","BACKGROUND


The influence of triacylglycerol (TAG) physical properties on satiety remains poorly understood.
OBJECTIVES


The objective was to investigate if and how TAG digestion and absorption, modulated only by differences in TAG crystallinity, would differentially affect short-term satiety in healthy men.
METHODS


We tempered 500 mL 10% palm stearin oil-in-water emulsions such that the lipid droplets were either undercooled liquid (LE) or partially crystalline solid (SE). Fifteen healthy men (mean ± SD age: 27.5 ± 5.7 y; BMI: 24.1 ± 2.5 kg/m2; fasting TAG: 0.9 ± 0.3 mmol/L) consumed each beverage at two 6-h study visits separated by ≥6 d after an overnight fast, along with 1500 mg acetaminophen suspended in water. The participants characterized the emulsion sensory properties, completed satiety visual analog scale ratings, and had serial blood samples collected for 6-h analysis of plasma peptide YY (PYY), glucagon-like peptide-1 (GLP-1), ghrelin, leptin, glucose-dependent insulinotropic polypeptide (GIP), insulin, and acetaminophen (for assessing gastric emptying). Repeated-measures ANOVAs and 2-tailed paired t tests were used to analyze the changes from baseline and incremental area under the curve (iAUC) values, respectively.
RESULTS


With consumption of LE compared with SE, there was a 358% higher fullness (P = 0.015) and a 103% lower average appetite (P = 0.041) score, along with higher iAUC values for PYY (P = 0.011) and GLP-1 (P = 0.028) (103% and 66% higher, respectively), but not for ghrelin (P = 0.39), based on change from baseline values. Acetaminophen response trended toward significance (P = 0.08) and was 15% higher with LE. SE was rated as 44% thicker (P = 0.034) and 24% creamier (P = 0.05) than LE.
CONCLUSIONS


The suppression of TAG digestion by the presence of partially crystalline lipid droplets blunted the appetite-suppressing effects of an oil-in-water emulsion.This trial was registered at clinicaltrials.gov as NCT03990246.",2020,"SE was rated as 44% thicker (P = 0.034) and 24% creamier (P = 0.05) than LE.
","['Healthy Adult Males', 'Fifteen healthy men (mean\xa0±', 'SD age: 27.5\xa0±\xa05.7 y', 'healthy men']","['SE', 'Acetaminophen', 'LE', 'acetaminophen suspended in water', 'Emulsion Droplet Crystallinity', '500\xa0mL 10% palm stearin oil-in-water emulsions such that the lipid droplets were either undercooled liquid (LE) or partially crystalline solid (SE']","['emulsion sensory properties, completed satiety visual analog scale ratings, and had serial blood samples collected for 6-h analysis of plasma peptide YY (PYY), glucagon-like peptide-1 (GLP-1), ghrelin, leptin, glucose-dependent insulinotropic polypeptide (GIP), insulin, and acetaminophen (for assessing gastric emptying', 'GLP-1', 'average appetite', 'fullness']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517674', 'cui_str': '27.5'}, {'cui': 'C4517795', 'cui_str': '5.7'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0038959', 'cui_str': 'Suspending Agents'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0014020', 'cui_str': 'Emulsions'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0230373', 'cui_str': 'Palm of hand (surface region)'}, {'cui': 'C0041111', 'cui_str': 'tristearin'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0230704', 'cui_str': 'Lipid droplet'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0444626', 'cui_str': 'Crystal'}, {'cui': 'C0205208', 'cui_str': 'Solid'}]","[{'cui': 'C0014020', 'cui_str': 'Emulsions'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}]",15.0,0.318938,"SE was rated as 44% thicker (P = 0.034) and 24% creamier (P = 0.05) than LE.
","[{'ForeName': 'Samar', 'Initials': 'S', 'LastName': 'Hamad', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Surangi H', 'Initials': 'SH', 'LastName': 'Thilakarathna', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Cuncins', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Wright', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, Canada.'}]",The Journal of nutrition,['10.1093/jn/nxaa164']
2840,32556249,Psychosocial Mechanisms of Cognitive-Behavioral-Based Physical Therapy Outcomes After Spine Surgery: Preliminary Findings From Mediation Analyses.,"OBJECTIVE


Changing Behavior Through Physical Therapy (CBPT), a cognitive-behavioral-based program, has been shown to improve outcomes after lumbar spine surgery in patients with a high psychosocial risk profile; however, little is known about potential mechanisms associated with CBPT treatment effects. The purpose of this study is to explore potential mediators underlying CBPT efficacy after spine surgery.
METHODS


In this secondary analysis, 86 participants were enrolled in a randomized trial comparing a postoperative CBPT (n = 43) and education program (n = 43). Participants completed validated questionnaires at 6 weeks (baseline) and 3 and 6 months following surgery for back pain (Brief Pain Inventory), disability (Oswestry Disability Index), physical health (SF-12), fear of movement (Tampa Scale of Kinesiophobia), pain catastrophizing (Pain Catastrophizing Scale), and pain self-efficacy (Pain Self-Efficacy Questionnaire). Parallel multiple mediation analyses using SPSS PROCESS were conducted to examine whether 3- and 6-month changes in fear of movement, pain catastrophizing, and pain self-efficacy mediate treatment outcome effects at 6 months.
RESULTS


Six-month changes, but not 3-month changes, in fear of movement and pain self-efficacy mediated postoperative outcomes at 6 months. Specifically, changes in fear of movement mediated the effects of CBPT treatment on disability (indirect effect = -2.0 [95% CI = -4.3 to 0.3]), whereas changes in pain self-efficacy mediated the effects of CBPT treatment on physical health (indirect effect = 3.5 [95% CI = 1.2 to 6.1]).
CONCLUSIONS


This study advances evidence on potential mechanisms underlying cognitive-behavioral strategies. Future work with larger samples is needed to establish whether these factors are a definitive causal mechanism.",2020,"[95% CI = -4.3 to 0.3]), whereas changes in pain self-efficacy mediated the effects of CBPT treatment on physical health (indirect effect = 3.5","['86 participants', 'patients with a high psychosocial risk profile', 'After Spine Surgery']","['Physical Therapy (CBPT', 'Cognitive-Behavioral-Based Physical Therapy Outcomes', 'CBPT', 'postoperative CBPT', 'education program']","['back pain (Brief Pain Inventory), disability (Oswestry Disability Index), physical health (SF-12), fear of movement (Tampa Scale of Kinesiophobia', 'fear of movement and pain self-efficacy mediated postoperative outcomes', 'pain catastrophizing (Pain Catastrophizing Scale), and pain self-efficacy (Pain Self-Efficacy Questionnaire', 'pain self-efficacy', 'physical health', 'fear of movement, pain catastrophizing, and pain self-efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0920347', 'cui_str': 'Procedure on spinal cord'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C4075347', 'cui_str': 'Pain Self-efficacy Questionnaire'}]",86.0,0.044694,"[95% CI = -4.3 to 0.3]), whereas changes in pain self-efficacy mediated the effects of CBPT treatment on physical health (indirect effect = 3.5","[{'ForeName': 'Rogelio A', 'Initials': 'RA', 'LastName': 'Coronado', 'Affiliation': 'Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, Tennessee; Department of Physical Medicine and Rehabilitation, Vanderbilt University Medical Center; and Center for Musculoskeletal Research, Vanderbilt University Medical Center.'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Ehde', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Jacquelyn S', 'Initials': 'JS', 'LastName': 'Pennings', 'Affiliation': 'Department of Orthopaedic Surgery, Vanderbilt University Medical Center and Center for Musculoskeletal Research, Vanderbilt University Medical Center.'}, {'ForeName': 'Susan W', 'Initials': 'SW', 'LastName': 'Vanston', 'Affiliation': 'Department of Orthopaedic Surgery, Vanderbilt University Medical Center.'}, {'ForeName': 'Tatsuki', 'Initials': 'T', 'LastName': 'Koyama', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center.'}, {'ForeName': 'Sharon E', 'Initials': 'SE', 'LastName': 'Phillips', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center.'}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Mathis', 'Affiliation': 'Department of Kinesiology, University of Alabama, Huntsville, Alabama.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'McGirt', 'Affiliation': 'Carolina Neurosurgery and Spine Associates, Charlotte, North Carolina.'}, {'ForeName': 'Dan M', 'Initials': 'DM', 'LastName': 'Spengler', 'Affiliation': 'Department of Orthopaedic Surgery, Vanderbilt University Medical Center.'}, {'ForeName': 'Oran S', 'Initials': 'OS', 'LastName': 'Aaronson', 'Affiliation': 'Howell Allen Clinic, Saint Thomas Medical Partners, Nashville, Tennessee.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Cheng', 'Affiliation': 'Department of Neurosurgery, University of Cincinnati School of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Clinton J', 'Initials': 'CJ', 'LastName': 'Devin', 'Affiliation': 'Department of Orthopaedic Surgery, Vanderbilt University Medical Center and Steamboat Orthopaedic and Spine Institute, Steamboat Springs, Colorado.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Wegener', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Johns Hopkins Medicine, Baltimore, Maryland.'}, {'ForeName': 'Kristin R', 'Initials': 'KR', 'LastName': 'Archer', 'Affiliation': 'Department of Orthopaedic Surgery, Center for Musculoskeletal Research, Vanderbilt University, 1215 21st Avenue S, Medical Center East - South Tower, Suite 4200, Nashville, TN 37232 (USA); Department of Physical Medicine and Rehabilitation, Vanderbilt University Medical Center; and Center for Musculoskeletal Research, Vanderbilt University Medical Center.'}]",Physical therapy,['10.1093/ptj/pzaa112']
2841,32556293,Identification and validation of a novel clinical signature to predict the prognosis in confirmed COVID-19 patients.,"BACKGROUND


This study aims to identify a prognostic biomarker to predict the disease prognosis and reduce the mortality rate of COVID-19, which has caused a worldwide pandemic.
METHODS


COVID-19 patients were randomly divided into training and test groups. Univariate and multivariate Cox regression analyses were performed to identify the disease prognosis signature, which was selected to establish a risk model in the training group. Furthermore, the disease prognosis signature of COVID-19 was validated in the test group.
RESULTS


The signature of COVID-19 was combined with five indicators, namely neutrophil count, lymphocyte count, procalcitonin, older age, and C-reactive protein. The signature stratified patients into high- and low-risk groups with significantly relevant disease prognosis (log-rank test, P<0.001) in the training group. The survival analysis indicated that the high-risk group displayed substantially lower survival probability than the low-risk group (log-rank test P<0.001). The area under ROC curve (AUC) showed that the signature of COVID-19 displayed the highest predictive accuracy regarding disease prognosis, which was 0.955 in the training group and 0.945 in the test group. The ROC analysis of both groups demonstrated that the predictive ability of the signature surpassed the use of each of the five indicators alone.
CONCLUSION


The signature of COVID-19 presents a novel predictor and prognostic biomarker for closely monitoring patients and providing timely treatment for those who are severely or critically ill.",2020,The survival analysis indicated that the high-risk group displayed substantially lower survival probability than the low-risk group (log-rank test P<0.001).,['COVID-19 patients'],[],"['survival probability', 'area under ROC curve (AUC', 'neutrophil count, lymphocyte count, procalcitonin, older age, and C-reactive protein', 'survival analysis']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0035787', 'cui_str': 'ROC Analysis'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte count'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}]",,0.0318789,The survival analysis indicated that the high-risk group displayed substantially lower survival probability than the low-risk group (log-rank test P<0.001).,"[{'ForeName': 'Shangrong', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Clinical Laboratory, Wuhan Fourth Hospital, Puai Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'Du', 'Affiliation': 'Department of Clinical Laboratory, Wuhan Fourth Hospital, Puai Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Sanying', 'Initials': 'S', 'LastName': 'Shen', 'Affiliation': 'Department of Respiratory Disease, Wuhan Fourth Hospital, Puai Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory Disease, Wuhan Fourth Hospital, Puai Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Emergency Medicine, Wuhan Fourth Hospital, Puai Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, Wuhan Fourth Hospital, Puai Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Cui', 'Affiliation': 'Department of Radiology, Wuhan Fourth Hospital, Puai Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Fangxiong', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'Department of Clinical Laboratory, Wuhan Fourth Hospital, Puai Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Clinical Laboratory, Wuhan Fourth Hospital, Puai Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa793']
2842,32556324,Dry Cupping Therapy for Improving Subcutaneous Hemodynamics and Pain Associated With Nonspecific Neck Pain.,"CONTEXT


Dry cupping therapy is a noninvasive treatment commonly used to reduce pain and promote the healing process in various populations, including those with nonspecific neck pain; however, no data are available to support most of this method's true physiological benefits.
OBJECTIVE


To determine if dry cupping therapy decreased pain and increased subcutaneous blood flow compared with sham cupping and control conditions.
DESIGN


Controlled laboratory study.
SETTING


Laboratory.
PATIENTS OR OTHER PARTICIPANTS


A total of 32 participants (age = 22.5 ± 2.8 years, height = 173.3 ± 10.1 cm, mass = 76.6 ± 18.7 kg) with self-reported nonspecific neck pain.
INTERVENTION(S)


We used dry cupping and sham cupping interventions and a control condition. For the dry cupping intervention, 1 stationary cup was placed directly over the most painful area for 8 minutes. The sham cupping intervention followed the same procedures as the dry cupping intervention except a sham cup was applied. For the control condition, participants received no treatment.
MAIN OUTCOME MEASURE(S)


Subjective pain intensity (visual analog scale); pain-pressure threshold; subcutaneous hemodynamics, including superficial and deep oxygenated, deoxygenated, and total hemoglobin levels; and tissue saturation index;.
RESULTS


We observed differences in the visual analog scale score and the superficial and deep oxygenated and total hemoglobin levels (P values ≤ .002) immediately postintervention compared with baseline. Post hoc tests revealed that the dry cupping group had less pain than the sham cupping and control groups and higher superficial and deep oxygenated and total hemoglobin levels (P values ≤ .008). No differences were found between baseline and 24 hours postintervention.
CONCLUSIONS


A single session of dry cupping therapy may be an effective short-term treatment method for immediately reducing pain and increasing oxygenated and total hemoglobin levels in patients with nonspecific neck pain.",2020,Post hoc tests revealed that the dry cupping group had less pain than the sham cupping and control groups and higher superficial and deep oxygenated and total hemoglobin levels (P values ≤ .008).,"['patients with nonspecific neck pain', 'A total of 32 participants (age = 22.5 ± 2.8 years, height = 173.3 ± 10.1 cm, mass = 76.6 ± 18.7 kg) with self-reported nonspecific neck pain']","['dry cupping and sham cupping interventions', 'Dry Cupping Therapy', 'sham cupping intervention']","['higher superficial and deep oxygenated and total hemoglobin levels', 'Subcutaneous Hemodynamics and Pain Associated With Nonspecific Neck Pain', 'Subjective pain intensity (visual analog scale); pain-pressure threshold; subcutaneous hemodynamics, including superficial and deep oxygenated, deoxygenated, and total hemoglobin levels; and tissue saturation index', 'pain and increased subcutaneous blood flow', 'pain and increasing oxygenated and total hemoglobin levels', 'pain', 'visual analog scale score and the superficial and deep oxygenated and total hemoglobin levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517649', 'cui_str': '22.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]","[{'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C5197695', 'cui_str': 'Cupping Treatment'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0475206', 'cui_str': '% total hemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",32.0,0.0555464,Post hoc tests revealed that the dry cupping group had less pain than the sham cupping and control groups and higher superficial and deep oxygenated and total hemoglobin levels (P values ≤ .008).,"[{'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Stephens', 'Affiliation': 'School of Kinesiology and Recreation, Illinois State University, Normal.'}, {'ForeName': 'Noelle M', 'Initials': 'NM', 'LastName': 'Selkow', 'Affiliation': 'School of Kinesiology and Recreation, Illinois State University, Normal.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Hoffman', 'Affiliation': 'School of Kinesiology and Recreation, Illinois State University, Normal.'}]",Journal of athletic training,['10.4085/1062-6050-236-19']
2843,32556348,Gait improvement in adults with hemiparesis using a rolling cane: A cross-over trial.,"OBJECTIVE


To assess the changes in gait parameters in adults with hemiparesis using a rolling cane (quadripod cane with small wheels; Wheeleo®) compared with a classical quadripod cane.
DESIGN


A prospective, multicentric, cross-over randomized trial.
PARTICIPANTS


Thirty-two ambulatory adults with hemiparesis.
METHODS


Participants were assessed using a quadripod cane and a rolling cane. Outcome measures were changes in: walking speed during a 10-m walk test and a 6-min walk test; frequency of 2-step gait; physiological cost index; number of therapist interventions to control the balance; perceived exertion; and participant satisfaction.
RESULTS


The following outcomes were improved with the use of a rolling cane: walking speed during a 10-m walk test at comfortable (+22%: p < 0.001) and maximal (+30: p < 0.001) speeds; walking speed (+50%: p < 0.001) and distance (+49%: p < 0.001) during a 6-min walk test; and the frequency of 2-step gait. The physiological cost index, perceived exertion, and number of therapist interventions to control the balance remained unchanged. Participant satisfaction improved.
CONCLUSION


A rolling cane, Wheeleo®, increases walking speed in adults with hemiparesis without additional risk of falls.",2020,The following outcomes were improved with the use of a rolling cane: walking speed during a 10-m walk test at comfortable (+22%: p < 0.001) and maximal (+30: p < 0.001) speeds; walking speed (+50%: p < 0.001) and distance (+49%: p < 0.001) during a 6-min walk test; and the frequency of 2-step gait.,"['adults with hemiparesis using a', 'Participants were assessed using a quadripod cane and a rolling cane', 'adults with hemiparesis without additional risk of falls', 'adults with hemiparesis using a rolling cane', 'Thirty-two ambulatory adults with hemiparesis']","['classical quadripod cane', 'rolling cane (quadripod cane with small wheels; Wheeleo®']","['frequency of 2-step gait', 'walking speed', 'rolling cane: walking speed during a 10-m walk test at comfortable', 'changes in: walking speed during a 10-m walk test and a 6-min walk test; frequency of 2-step gait; physiological cost index; number of therapist interventions to control the balance; perceived exertion; and participant satisfaction', 'physiological cost index, perceived exertion, and number of therapist interventions', 'gait parameters', 'Participant satisfaction improved', 'Gait improvement']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018989', 'cui_str': 'Hemiparesis'}, {'cui': 'C0006856', 'cui_str': 'Cane'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0006856', 'cui_str': 'Cane'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0006856', 'cui_str': 'Cane'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",32.0,0.113001,The following outcomes were improved with the use of a rolling cane: walking speed during a 10-m walk test at comfortable (+22%: p < 0.001) and maximal (+30: p < 0.001) speeds; walking speed (+50%: p < 0.001) and distance (+49%: p < 0.001) during a 6-min walk test; and the frequency of 2-step gait.,"[{'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Deltombe', 'Affiliation': 'Physical Medicine and Rehabilitation Department, Université catholique de Louvain, Cliniques universitaires de Mont-Godinne, BE-5530 Yvoir, Belgium. E-mail: thierry.deltombe@uclouvain.be.'}, {'ForeName': 'Mie', 'Initials': 'M', 'LastName': 'Leeuwerck', 'Affiliation': ''}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Jamart', 'Affiliation': ''}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Frederick', 'Affiliation': ''}, {'ForeName': 'Geoffroy', 'Initials': 'G', 'LastName': 'Dellicour', 'Affiliation': ''}]",Journal of rehabilitation medicine,['10.2340/16501977-2705']
2844,32556518,Effect of high-dose vitamin D supplementation on peripheral arterial calcification: secondary analysis of a randomized controlled trial.,"Although high-dose vitamin D supplementation is common, effects on arterial calcification remain unexplored. Tibial artery calcification was identified and quantified over 3 years in participants randomized to 400, 4000, or 10,000 IU vitamin D 3  daily. High-dose vitamin D supplementation did not affect the development or progression of arterial calcification.
INTRODUCTION


To determine whether vitamin D supplementation has a dose-dependent effect on development and progression of arterial calcification.
METHODS


This was a secondary analysis of the Calgary Vitamin D Study, a 3-year, double-blind, randomized controlled trial conducted at a single-center in Calgary, Canada. Participants were community-dwelling adults aged 55-70 years with serum 25-hydroxyvitamin D 30-125 nmol/L. Participants were randomized 1:1:1 to receive vitamin D 3  400, 4000, or 10,000 IU/day for 3 years. Tibial artery calcification was identified and quantified (in milligrams of hydroxyapatite, mgHA) using high-resolution peripheral quantitative computed tomography (HR-pQCT) at baseline and 6, 12, 24, and 36 months. Changes in calcification over time and treatment group interaction were evaluated using a constrained linear mixed effects model.
RESULTS


Of 311 randomized participants, 302 (400: 105, 4000: 96, 10,000: 101) were eligible for analysis of arterial calcification (54% male, mean (SD) age 62 (4) years, mean (SD) 25-hydroxyvitamin D 78.9 (19.9) nmol/L). At baseline, 85 (28%) had tibial artery calcification, and mean (95% CI) calcification quantity was 2.8 mgHA (95% CI 1.7-3.9). In these 85 participants, calcification quantity increased linearly by 0.020 mgHA/month (95% CI 0.012-0.029) throughout the study, with no evidence of a treatment-group effect (p = 0.645 for interaction). No participants developed new arterial calcifications during the study.
CONCLUSIONS


In this population of community-dwelling adults who were vitamin D replete at baseline, supplementation with vitamin D 400, 4000, or 10,000 IU/day did not have differential effects on the development or progression of arterial calcification over 3 years.
TRIAL REGISTRATION


clinicaltrials.gov (NCT01900860).",2020,"In these 85 participants, calcification quantity increased linearly by 0.020 mgHA/month (95% CI 0.012-0.029) throughout the study, with no evidence of a treatment-group effect (p = 0.645 for interaction).","['Of 311 randomized participants, 302 (400: 105', '4000: 96, 10,000: 101) were eligible for analysis of arterial calcification (54% male, mean (SD) age 62 (4) years, mean (SD) 25-hydroxyvitamin', 'Participants were community-dwelling adults aged 55-70\xa0years with serum 25-hydroxyvitamin D 30-125\xa0nmol/L. Participants']","['high-dose vitamin D supplementation', 'vitamin D', 'vitamin D supplementation', 'High-dose vitamin D supplementation']","['Tibial artery calcification', 'calcification quantity', 'development or progression of arterial calcification', 'peripheral arterial calcification', 'new arterial calcifications', 'tibial artery calcification']","[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C3842327', 'cui_str': '4000'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1168153', 'cui_str': 'Arterial calcification'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0439282', 'cui_str': 'nmol/L'}]","[{'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0085427', 'cui_str': 'Tibial artery'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C1168153', 'cui_str': 'Arterial calcification'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0205314', 'cui_str': 'New'}]",101.0,0.772187,"In these 85 participants, calcification quantity increased linearly by 0.020 mgHA/month (95% CI 0.012-0.029) throughout the study, with no evidence of a treatment-group effect (p = 0.645 for interaction).","[{'ForeName': 'E O', 'Initials': 'EO', 'LastName': 'Billington', 'Affiliation': 'McCaig Institute for Bone and Joint Health, Cumming School of Medicine, University of Calgary, Calgary, Canada. emma.billington@ahs.ca.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Burt', 'Affiliation': 'McCaig Institute for Bone and Joint Health, Cumming School of Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Plett', 'Affiliation': 'McCaig Institute for Bone and Joint Health, Cumming School of Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Rose', 'Affiliation': 'Research Facilitation, Alberta Health Services, Calgary, Canada.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Boyd', 'Affiliation': 'McCaig Institute for Bone and Joint Health, Cumming School of Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Hanley', 'Affiliation': 'McCaig Institute for Bone and Joint Health, Cumming School of Medicine, University of Calgary, Calgary, Canada.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-020-05500-2']
2845,32556539,"Absence of QTc prolongation in a thorough QT study with imeglimin, a first in class oral agent for type 2 diabetes mellitus.","PURPOSE


Imeglimin is the first in a new class of oral antidiabetic agents, the glimins, currently in development to improve glycemic control in patients with type 2 diabetes mellitus. A thorough QT study was conducted to establish electrophysiological effects of therapeutic and supratherapeutic doses of imeglimin on cardiac repolarization.
METHODS


In this randomized, double-blind, four-period, placebo and active controlled crossover study, healthy subjects were administered a single dose of imeglimin 2250 mg, imeglimin 6000 mg, moxifloxacin 400 mg, and placebo. 12-Lead Holter ECGs were recorded from 1 h before dosing until at least 24 h after each dose. This study was performed at a single-center inpatient clinical pharmacology unit.
RESULTS


The upper bound of the two-sided 90% confidence interval for time-matched, placebo-subtracted, baseline-adjusted QTc intervals (ΔΔQTcF) did not exceed the regulatory threshold of 10 ms in any of the imeglimin dose groups. There were no QTcF values above 500 ms nor changes from pre-dose in QTcF above 60 ms in the imeglimin groups. Imeglimin did not exert a relevant effect on heart rate and PR or QRS intervals. Assay sensitivity was demonstrated by the effect of moxifloxacin 400 mg, with a lower bound two-sided 90% confidence interval for ΔΔQTcF of 10.6 ms.
CONCLUSION


This thorough QT study demonstrated that therapeutic and supratherapeutic exposures of imeglimin did not induce a QT/QTc prolongation with a strong confidence as evidenced by the assay sensitivity.
TRIAL REGISTRATION NUMBER/DATE


NCT02924337/ October 5, 2016.",2020,There were no QTcF values above 500 ms nor changes from pre-dose in QTcF above 60 ms in the imeglimin groups.,"['patients with type 2 diabetes mellitus', 'type 2 diabetes mellitus', 'healthy subjects']","['imeglimin 2250 mg, imeglimin 6000 mg, moxifloxacin 400 mg, and placebo', 'moxifloxacin', 'placebo']","['QTcF values', 'heart rate and PR or QRS intervals', 'Assay sensitivity', '12-Lead Holter ECGs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3501765', 'cui_str': 'imeglimin'}, {'cui': 'C3842326', 'cui_str': '6000'}, {'cui': 'C1126029', 'cui_str': 'moxifloxacin 400 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0520880', 'cui_str': 'QRS interval'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}]",,0.169849,There were no QTcF values above 500 ms nor changes from pre-dose in QTcF above 60 ms in the imeglimin groups.,"[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Dubourg', 'Affiliation': 'POXEL S.A., 259/261 Avenue Jean Jaurès, 69007, Lyon, France. julie.dubourg@poxelpharma.com.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Perrimond-Dauchy', 'Affiliation': 'POXEL S.A., 259/261 Avenue Jean Jaurès, 69007, Lyon, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Felices', 'Affiliation': 'Phinc Development, 36 rue Victor Basch, Massy, 91300, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Bolze', 'Affiliation': 'POXEL S.A., 259/261 Avenue Jean Jaurès, 69007, Lyon, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Voiriot', 'Affiliation': 'Banook group, 84 avenue du XXeme Corps, Nancy, 54000, France.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Fouqueray', 'Affiliation': 'POXEL S.A., 259/261 Avenue Jean Jaurès, 69007, Lyon, France.'}]",European journal of clinical pharmacology,['10.1007/s00228-020-02929-6']
2846,32556585,Comparable increases in dural sac area after three different posterior decompression techniques for lumbar spinal stenosis: radiological results from a randomized controlled trial in the NORDSTEN study.,"PURPOSE


To investigate changes in dural sac area after three different posterior decompression techniques in patients undergoing surgery for lumbar spinal stenosis. Decompression of the nerve roots is the main surgical treatment for lumbar spinal stenosis. The aim of this study was to radiologically investigate three commonly used posterior decompression techniques.
METHODS


The present study reports data from one of two multicenter randomized trials included in the NORDSTEN study. In the present trial, involving 437 patients undergoing surgery, we report radiological results after three different midline retaining posterior decompression techniques: unilateral laminotomy with crossover (UL) (n = 146), bilateral laminotomy (BL) (n = 142) and spinous process osteotomy (SPO) (n = 149). MRI was performed before and three months after surgery. The increase in dural sac area and Schizas grade at the most stenotic level was evaluated. Three different predefined surgical indicators of substantial decompression were used: (1) postoperative dural sac area of > 100 mm 2 , (2) increase in the dural sac area of at least 50% and (3) postoperative Schizas grade A or B.
RESULTS


No differences between the three surgical groups were found in the mean increase in dural sac area. Mean values were 66.0 (SD 41.5) mm 2  in the UL-group, 71.9 (SD 37.1) mm 2  in the BL-group and 68.1 (SD 41.0) mm 2  in the SPO-group (p = 0.49). No differences in the three predefined surgical outcomes between the three groups were found.
CONCLUSION


For patients with lumbar spinal stenosis, the three different surgical techniques provided the same increase in dural sac area.
CLINICAL TRIAL REGISTRATION


The study is registered at ClinicalTrials.gov reference on November 22th 2013 under the identifier NCT02007083.",2020,No differences between the three surgical groups were found in the mean increase in dural sac area.,"['437 patients undergoing surgery, we report radiological results after three different midline retaining posterior decompression techniques: unilateral laminotomy with crossover (UL) (n\u2009=\u2009146', 'patients with lumbar spinal stenosis', 'patients undergoing surgery for lumbar spinal stenosis', 'lumbar spinal stenosis']","['posterior decompression techniques', 'bilateral laminotomy (BL) (n\u2009=\u2009142) and spinous process osteotomy (SPO']","['Mean values', 'dural sac area', 'dural sac area and\xa0Schizas grade', 'dural sac area of at least 50% and (3) postoperative Schizas grade A or B']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0392866', 'cui_str': 'Laminotomy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0158288', 'cui_str': 'Spinal stenosis of lumbar region'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0392866', 'cui_str': 'Laminotomy'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0309195', 'cui_str': 'Grade A'}]",437.0,0.0565306,No differences between the three surgical groups were found in the mean increase in dural sac area.,"[{'ForeName': 'Erland', 'Initials': 'E', 'LastName': 'Hermansen', 'Affiliation': 'Department of Orthopedic Surgery, Ålesund Hospital, Møre and Romsdal Hospital Trust, Ålesund, Norway. Erland.hermansen@helse-bergen.no.'}, {'ForeName': 'Ivar Magne', 'Initials': 'IM', 'LastName': 'Austevoll', 'Affiliation': 'Kysthospitalet in Hagevik. Orthopedic Clinic, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hellum', 'Affiliation': 'Division of Orthopedic Surgery, Oslo University Hospital Ulleval, Oslo, Norway.'}, {'ForeName': 'Kjersti', 'Initials': 'K', 'LastName': 'Storheim', 'Affiliation': 'Communication and Research Unit for Musculoskeletal Health (FORMI), Oslo University Hospital,, Oslo, Norway.'}, {'ForeName': 'Tor Åge', 'Initials': 'TÅ', 'LastName': 'Myklebust', 'Affiliation': 'Department of Research and Innovation, Møre and Romsdal Hospital Trust, Ålesund, Norway.'}, {'ForeName': 'Jørn', 'Initials': 'J', 'LastName': 'Aaen', 'Affiliation': 'Department of Orthopedic Surgery, Ålesund Hospital, Møre and Romsdal Hospital Trust, Ålesund, Norway.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Banitalebi', 'Affiliation': 'Department of Diagnostic Imaging, Akershus University Hospital,, Oslo, Norway.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Anvar', 'Affiliation': 'Unilabs Radiology, Oslo, Norway.'}, {'ForeName': 'Frode', 'Initials': 'F', 'LastName': 'Rekeland', 'Affiliation': 'Kysthospitalet in Hagevik. Orthopedic Clinic, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Jens Ivar', 'Initials': 'JI', 'LastName': 'Brox', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Franssen', 'Affiliation': 'Department of Orthopaedics, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Weber', 'Affiliation': 'Department of Neurosurgery, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Tore', 'Initials': 'T', 'LastName': 'Solberg', 'Affiliation': 'Department of Neurosurgery and the Norwegian Registry for Spine Surgery (NORspine), University Hospital of Northern Norway, Tromsö, Norway.'}, {'ForeName': 'Knut Jørgen', 'Initials': 'KJ', 'LastName': 'Haug', 'Affiliation': 'Departement of Orthopedic Surgery, Telemark Regional Hospital, Skien, Norway.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Grundnes', 'Affiliation': 'Department of Orthopedics, Akershus University Hospital, Oslo, Norway.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Brisby', 'Affiliation': 'Department of Orthopaedics, Sahlgrenska University Hospital, Göteborg, Sweden.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Indrekvam', 'Affiliation': 'Kysthospitalet in Hagevik. Orthopedic Clinic, Haukeland University Hospital, Bergen, Norway.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-020-06499-0']
2847,32556595,Preliminary evidence of effects of potassium chloride on a metabolomic path to diabetes and cardiovascular disease.,"INTRODUCTION


Low potassium intake can affect cardiovascular disease (CVD) risk and cardiometabolic risk factors.
OBJECTIVE


We hypothesize that potassium chloride (KCl) supplementation can improve cardiovascular risk metabolomic profile.
METHODS


In this secondary analysis of a pilot randomized clinical trial (RCT) of 26 participants with prediabetes randomized to KCl or placebo, we performed targeted mass-spectrometry-based metabolomic profiling on baseline and 12-week (end-of-study) plasma samples. Principal component analysis (PCA) was used to reduce the many correlated metabolites into fewer, independent factors that retain most of the information in the original data.
RESULTS


Those taking KCl had significant reductions (corresponding to lower cardiovascular risk) in the branched-chain amino acids (BCAA) factor (P = 0.004) and in valine levels (P = 0.02); and non-significant reductions in short-chain acylcarnitines (SCA) factor (P = 0.11).
CONCLUSIONS


KCl supplementation may improve circulating BCAA levels, which may reflect improvements in overall cardiometabolic risk profile.
CLINICAL TRIALS REGISTRY


Clinicaltrials.gov identifier: NCT02236598; https://clinicaltrials.gov/ct2/show/NCT02236598.",2020,"Those taking KCl had significant reductions (corresponding to lower cardiovascular risk) in the branched-chain amino acids (BCAA) factor (P = 0.004) and in valine levels (P = 0.02); and non-significant reductions in short-chain acylcarnitines (SCA) factor (P = 0.11).
",['26 participants with prediabetes randomized to'],"['potassium chloride (KCl) supplementation', 'potassium chloride', 'KCl supplementation', 'KCl or placebo']","['circulating BCAA levels', 'short-chain acylcarnitines (SCA) factor', 'metabolomic path to diabetes and cardiovascular disease', 'cardiovascular risk metabolomic profile', 'overall cardiometabolic risk profile', 'valine levels']","[{'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}]","[{'cui': 'C0032825', 'cui_str': 'Potassium Chloride'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0368608', 'cui_str': 'Acylcarnitine'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0042285', 'cui_str': 'Valine'}]",26.0,0.492144,"Those taking KCl had significant reductions (corresponding to lower cardiovascular risk) in the branched-chain amino acids (BCAA) factor (P = 0.004) and in valine levels (P = 0.02); and non-significant reductions in short-chain acylcarnitines (SCA) factor (P = 0.11).
","[{'ForeName': 'Ranee', 'Initials': 'R', 'LastName': 'Chatterjee', 'Affiliation': 'Department of Medicine, Duke University, 200 Morris Street, 3rd Floor, Durham, NC, 27701, USA. ranee.chatterjee@duke.edu.'}, {'ForeName': 'Clemontina A', 'Initials': 'CA', 'LastName': 'Davenport', 'Affiliation': 'Department of Medicine, Duke University, 200 Morris Street, 3rd Floor, Durham, NC, 27701, USA.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Kwee', 'Affiliation': 'Duke Molecular Physiology Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': ""D'Alessio"", 'Affiliation': 'Department of Medicine, Duke University, 200 Morris Street, 3rd Floor, Durham, NC, 27701, USA.'}, {'ForeName': 'Laura P', 'Initials': 'LP', 'LastName': 'Svetkey', 'Affiliation': 'Department of Medicine, Duke University, 200 Morris Street, 3rd Floor, Durham, NC, 27701, USA.'}, {'ForeName': 'Pao-Hwa', 'Initials': 'PH', 'LastName': 'Lin', 'Affiliation': 'Department of Medicine, Duke University, 200 Morris Street, 3rd Floor, Durham, NC, 27701, USA.'}, {'ForeName': 'Cris A', 'Initials': 'CA', 'LastName': 'Slentz', 'Affiliation': 'Department of Medicine, Duke University, 200 Morris Street, 3rd Floor, Durham, NC, 27701, USA.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Ilkayeva', 'Affiliation': 'Duke Molecular Physiology Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Johnson', 'Affiliation': 'Duke Molecular Physiology Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Edelman', 'Affiliation': 'Department of Medicine, Duke University, 200 Morris Street, 3rd Floor, Durham, NC, 27701, USA.'}, {'ForeName': 'Svati H', 'Initials': 'SH', 'LastName': 'Shah', 'Affiliation': 'Department of Medicine, Duke University, 200 Morris Street, 3rd Floor, Durham, NC, 27701, USA.'}]",Metabolomics : Official journal of the Metabolomic Society,['10.1007/s11306-020-01696-w']
2848,32556601,Effects of spinal anesthesia and sedation with dexmedetomidine or propofol on cerebral regional oxygen saturation and systemic oxygenation a period after spinal injection.,"PURPOSE


To evaluate changes in cerebral regional oxygen saturation (rSO 2 ) after spinal anesthesia and compare the changes in rSO 2  and systemic oxygenation between dexmedetomidine sedation and propofol sedation.
METHODS


Thirty-six patients scheduled to undergo transurethral surgery under spinal anesthesia were randomly assigned to the dexmedetomidine (n = 18) and propofol groups (n = 18). We used near-infrared spectroscopy sensors to measure rSO 2 , and obtained data from each side were averaged. After oxygen insufflation, baseline measurements of mean arterial blood pressure (MAP), heart rate, rSO 2 , pulse oximetry saturation (SpO 2 ), bispectral index, and body temperature were made. After spinal anesthesia, we measured these parameters every 5 min. Twenty minutes after spinal injection, dexmedetomidine or propofol administration was started. We measured each parameter at 10, 25, and 40 min after the administration of dexmedetomidine or propofol.
RESULTS


The baseline rSO 2  in the dexmedetomidine group was 71.3 ± 7.3%, and that in the propofol group was 71.8 ± 5.6%. After spinal anesthesia, rSO 2  in both groups decreased significantly (dexmedetomidine group: 65.4 ± 6.9%; propofol group: 64.3 ± 7.4%). After administering sedatives, rSO 2  was equivalent after spinal anesthesia. rSO 2  was comparable between the two groups. MAP and SpO 2  were significantly higher in the dexmedetomidine group than in the propofol group.
CONCLUSION


Spinal anesthesia decreased rSO 2 ; however, the decline was not severe. Dexmedetomidine and propofol did not compromise cerebral oxygenation under spinal anesthesia. Nevertheless, MAP and SpO 2  were more stable in dexmedetomidine sedation than in propofol sedation. Dexmedetomidine may be suitable for spinal anesthesia.",2020,"After spinal anesthesia, rSO 2  in both groups decreased significantly (dexmedetomidine group: 65.4 ± 6.9%; propofol group: 64.3 ± 7.4%).",['Thirty-six patients scheduled to undergo transurethral surgery under spinal anesthesia'],"['Dexmedetomidine and propofol', 'Dexmedetomidine', 'dexmedetomidine sedation and propofol sedation', 'dexmedetomidine or propofol', 'spinal anesthesia and sedation with dexmedetomidine or propofol', 'propofol', 'dexmedetomidine']","['cerebral regional oxygen saturation and systemic oxygenation', 'MAP and SpO 2', 'cerebral regional oxygen saturation', 'mean arterial blood pressure (MAP), heart rate, rSO 2 , pulse oximetry saturation (SpO 2 ), bispectral index, and body temperature']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0034108', 'cui_str': 'Pulse oximetry'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}]",36.0,0.0231253,"After spinal anesthesia, rSO 2  in both groups decreased significantly (dexmedetomidine group: 65.4 ± 6.9%; propofol group: 64.3 ± 7.4%).","[{'ForeName': 'Yasutomo', 'Initials': 'Y', 'LastName': 'Kumakura', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, University of Yamanashi, 1110 Shimokato, Chuo, Yamanashi, 409-3898, Japan. ykurakuma@yamanashi.ac.jp.'}, {'ForeName': 'Tadahiko', 'Initials': 'T', 'LastName': 'Ishiyama', 'Affiliation': 'Surgical Center, University of Yamanashi Hospital, University of Yamanashi, Yamanashi, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Matsuoka', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, University of Yamanashi, 1110 Shimokato, Chuo, Yamanashi, 409-3898, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Iijima', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, University of Yamanashi, 1110 Shimokato, Chuo, Yamanashi, 409-3898, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Matsukawa', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, University of Yamanashi, 1110 Shimokato, Chuo, Yamanashi, 409-3898, Japan.'}]",Journal of anesthesia,['10.1007/s00540-020-02816-5']
2849,32556602,Effect of food on the pharmacokinetics of the WEE1 inhibitor adavosertib (AZD1775) in patients with advanced solid tumors.,"PURPOSE


To support future dosing recommendations, the effect of food on the pharmacokinetics of adavosertib, a first-in-class, small-molecule reversible inhibitor of WEE1 kinase, was assessed in patients with advanced solid tumors.
METHODS


In this Phase I, open-label, randomized, two-period, two-sequence crossover study, the pharmacokinetics of a single 300 mg adavosertib dose were investigated in fed versus fasted states.
RESULTS


Compared with the fasted state, a high-fat, high-calorie meal (fed state) decreased adavosertib maximum plasma concentration (C max ) by 16% and systemic exposure (area under the plasma concentration-time curve [AUC]) by 6%; AUC 0-t  decreased by 7% and time to maximum plasma concentration was delayed by 1.97 h (P = 0.0009). The 90% confidence interval of the geometric least-squares mean treatment ratio for AUC and AUC 0-t  was contained within the no-effect limits (0.8-1.25), while that of C max  crossed the lower bound of the no-effect limits. Adverse events (AEs) related to adavosertib treatment were reported by 20 (64.5%) of the 31 patients treated in this study. Grade ≥ 3 AEs were reported by four (12.9%) patients (one in the fed state, three in the fasted state); two of these AEs were considered treatment-related by the investigator. Three serious AEs were reported in three (9.7%) patients; these were not considered treatment-related. No patients discontinued because of treatment-related AEs, and no new safety signals were reported.
CONCLUSION


A high-fat meal did not have a clinically relevant effect on the systemic exposure of adavosertib, suggesting that adavosertib can be administered without regard to meals.",2020,"A high-fat meal did not have a clinically relevant effect on the systemic exposure of adavosertib, suggesting that adavosertib can be administered without regard to meals.",['patients with advanced solid tumors'],['WEE1 inhibitor adavosertib (AZD1775'],"['adavosertib maximum plasma concentration (C max ', 'Adverse events (AEs) related to adavosertib treatment', 'maximum plasma concentration', 'Grade\u2009≥']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C4053677', 'cui_str': 'AZD-1775'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",,0.0666379,"A high-fat meal did not have a clinically relevant effect on the systemic exposure of adavosertib, suggesting that adavosertib can be administered without regard to meals.","[{'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Någård', 'Affiliation': 'Clinical Pharmacology and Quantitative Pharmacology, R&D Clinical Pharmacology and Safety Sciences, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Mei-Lin', 'Initials': 'ML', 'LastName': 'Ah-See', 'Affiliation': 'Late Stage Development, Oncology R&D, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'So', 'Affiliation': 'Late Stage Development, Oncology R&D, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Vermunt', 'Affiliation': 'The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Thistlethwaite', 'Affiliation': 'The Christie NHS Foundation Trust and University of Manchester, Manchester, UK.'}, {'ForeName': 'Mariette', 'Initials': 'M', 'LastName': 'Labots', 'Affiliation': 'Cancer Center Amsterdam, Amsterdam UMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Roxburgh', 'Affiliation': 'Beaston West of Scotland Cancer Centre and University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Ravaud', 'Affiliation': 'Bordeaux University Hospital, Bordeaux, France.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Campone', 'Affiliation': 'ICO - Site René, Saint Herblain, France.'}, {'ForeName': 'Liselot', 'Initials': 'L', 'LastName': 'Valkenburg-van Iersel', 'Affiliation': 'Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Ottesen', 'Affiliation': 'Late Stage Development, Oncology R&D, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Clinical Pharmacology Biologics and Bioanalysis, Clinical Pharmacology and Safety Science, BioPharmaceuticals R&D, AstraZeneca, Boston, MA, USA.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Mugundu', 'Affiliation': 'Clinical Pharmacology and Quantitative Pharmacology, R&D Clinical Pharmacology and Safety Sciences, AstraZeneca, 35 Gatehouse Drive, Waltham, MA, 02451, USA. ganesh.mugundu@astrazeneca.com.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-020-04101-4']
2850,32556606,"Magnetic Tracking and Electrocardiography-Guided Tip Confirmation System Versus Fluoroscopy for Placement of Peripherally Inserted Central Catheters: A Randomized, Noninferiority Comparison.","PURPOSE


To determine whether the use of a magnetic tracking and electrocardiography-guided catheter tip confirmation system (TCS) is safe and noninferior to fluoroscopy concerning positioning accuracy of a peripheral inserted central catheter (PICC).
METHODS


In this prospective, randomized, single-center study, adult patients scheduled for PICC insertion were assigned 1:1 either to TCS or fluoroscopy. The primary objective was a noninferiority comparison of correct PICC tip position confirmed by X-ray obtained immediately after catheter insertion. Time needed for PICC insertion and insertion-related complications up to 14 days after the procedure were secondary outcomes to be assessed for superiority.
RESULTS


A total of 210 patients (62.3 ± 14.4 years, 63.8% male) were included at a single German center between June 2016 and October 2017. Correct PICC tip position was achieved in 84 of 103 TCS (82.4%) and 103 of 104 fluoroscopy patients (99.0%). One-sided 95% lower confidence limit on the difference between proportions was -23.1%. Thus, noninferiority of TCS was not established (p > 0.99). Insertion of PICC took longer with TCS compared to fluoroscopy (8.4 ± 3.7 min vs. 5.0 ± 2.7 min, p < 0.001). Incidence of complications within a mean follow-up of 5.0 ± 2.3 days did not differ significantly between groups.
CONCLUSION


Noninferiority of TCS to fluoroscopy in the incidence of correct PICC tip position was not reached. Ancillary benefit of TCS over fluoroscopy including less radiation exposure and lower resource requirements may nonetheless justify the use of TCS. The study is registered with Clinical.Trials.gov (Identifier: NCT02929368).",2020,"CONCLUSION


Noninferiority of TCS to fluoroscopy in the incidence of correct PICC tip position was not reached.","['210 patients (62.3\u2009±\u200914.4\xa0years, 63.8% male) were included at a single German center between June 2016 and October 2017', 'adult patients scheduled for PICC insertion']","['Magnetic Tracking and Electrocardiography-Guided Tip Confirmation System', 'TCS or fluoroscopy', 'TCS', 'magnetic tracking and electrocardiography-guided catheter tip confirmation system (TCS', 'Inserted Central Catheters']","['Time needed for PICC insertion and insertion-related complications', 'Correct PICC tip position', 'Incidence of complications']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}]","[{'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0521091', 'cui_str': 'Confirmation of'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0221799', 'cui_str': 'Intravascular guiding catheter'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0444299', 'cui_str': 'Catheter tip'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",210.0,0.174291,"CONCLUSION


Noninferiority of TCS to fluoroscopy in the incidence of correct PICC tip position was not reached.","[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Mack', 'Affiliation': 'Department of Radiology, Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Nißler', 'Affiliation': 'Department of Radiology, Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kasikci', 'Affiliation': 'Department of Radiology, Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Malouhi', 'Affiliation': 'Department of Radiology, Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Aschenbach', 'Affiliation': 'Department of Radiology, Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Teichgräber', 'Affiliation': 'Department of Radiology, Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany. ulf.teichgraeber@med.uni-jena.de.'}]",Cardiovascular and interventional radiology,['10.1007/s00270-020-02551-0']
2851,32556619,Assessment of patient-specific titanium onlay versus autogenous inlay eminoplasty technique for treatment of recurrent temporomandibular joint dislocation: a randomized clinical trial.,"PURPOSE


Various procedures have been adopted for eminence augmentation for treatment of recurrent temporomandibular joint dislocation. The aim of this study is to assess maximal incisal opening (MIO) using a custom-made titanium implant versus inlay autogenous augmentation from the patient's chin for more stable condylar movements.
METHODS


Ten patients were treated in this study (20 joints) five patients with bilateral patient-specific titanium onlay implant and five for autogenous inlay grafting technique; each implant in the study group was virtually designed using a specific software and milled from titanium grade V blocks, then fixed with mini screws at the lateral aspect of the zygomatic arch while in the control group, autogenous corticocancellous bone block was harvested from the chin and wedged at the created defect of the eminence to increase its height.
RESULTS


The follow-up period ranged from 6 months to 1 year to access the maximal incisal opening (MIO). The mean preoperative maximal incisal opening was 47.8 mm and that of the postoperative was 33.2 mm in the study group and 35.4 mm in the control group, respectively. One patient reported postoperative slight unilateral edema and pain that gradually diminishes after 1 month postoperative.
CONCLUSION


No statistical difference between both groups p value 0.3.",2020,No statistical difference between both groups p value 0.3.,"['Ten patients were treated in this study (20 joints) five patients with bilateral patient', 'recurrent temporomandibular joint dislocation']","['specific titanium onlay implant and five for autogenous inlay grafting technique', 'patient-specific titanium onlay versus autogenous inlay eminoplasty technique', 'custom-made titanium implant versus inlay autogenous augmentation']","['mean preoperative maximal incisal opening', 'maximal incisal opening (MIO', 'postoperative slight unilateral edema and pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0159914', 'cui_str': 'Dislocation of temporomandibular joint'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0021513', 'cui_str': 'Dental Inlays'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C4040028', 'cui_str': 'Incisal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2937276', 'cui_str': 'Slight'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",10.0,0.0293004,No statistical difference between both groups p value 0.3.,"[{'ForeName': 'Rania', 'Initials': 'R', 'LastName': 'Ihab', 'Affiliation': 'Oral and Maxillofacial Surgery Department, MSA University, 6th of October, Egypt.'}, {'ForeName': 'Ragia', 'Initials': 'R', 'LastName': 'Mounir', 'Affiliation': 'Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University, 12 saray el manial street, El Manial, Cairo, Egypt.'}, {'ForeName': 'Sherif', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University, 12 saray el manial street, El Manial, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Mounir', 'Affiliation': 'Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University, 12 saray el manial street, El Manial, Cairo, Egypt.'}]",Oral and maxillofacial surgery,['10.1007/s10006-020-00861-8']
2852,32556658,Influence of endodontic cavity access on curved root canal preparation with ProDesign Logic rotary instruments.,"OBJECTIVE


This study evaluates whether endodontic cavity access into molars influences the chemomechanical preparation of curved root canals.
MATERIALS AND METHODS


Twenty mesiobuccal canals of maxillary molars were randomly divided into two experimental groups (n = 10), according to the type of endodontic access analyzed (conventional and minimally invasive). The preparations were made by a single operator, and the canals, after access, were prepared with Logic system (0.25, 0.04 taper) along the working length. Samples were scanned before and after canal preparation (SMX-90CT Plus (Shimadzu® microtomograph operated with 70 kV, 100 uA, FOV (XY) 13.3 mm, FOV (Z) 7.0 mm, and voxel size 0.013 mm/Pix)) to match canal volumes. Images were analyzed to evaluate surface areas, transport, and centralization at 3 mm from the canal entrance and 3 mm from the apex (OnDemand3D TM  Dental software). Student's t test with a significance level of 5% was used for the statistical analysis.
RESULTS


Regardless of the position of the analyzed canals, there was no difference in the prepared area regarding the transport and centralization of the endodontic instrument between the two types of cavity accesses performed.
CONCLUSIONS


The conventional and minimally invasive access did not influence the action of the 0.25 and 0.04 taper instrument during the curved root canal preparation.
CLINICAL RELEVANCE


The type of endodontic access did not influence the action of the rotary instrument during the curved root canal preparation.",2020,"The conventional and minimally invasive access did not influence the action of the 0.25 and 0.04 taper instrument during the curved root canal preparation.
",['Twenty mesiobuccal canals of maxillary molars'],"['endodontic access analyzed (conventional and minimally invasive', 'canal preparation (SMX-90CT Plus (Shimadzu® microtomograph']",[],"[{'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0332274', 'cui_str': 'Endodontic'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0038689', 'cui_str': 'Sulfamethoxazole'}, {'cui': 'C0332287', 'cui_str': 'With'}]",[],,0.0745394,"The conventional and minimally invasive access did not influence the action of the 0.25 and 0.04 taper instrument during the curved root canal preparation.
","[{'ForeName': 'Gabiana Rodrigues', 'Initials': 'GR', 'LastName': 'Freitas', 'Affiliation': 'Dentistry College, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Thais Marchand', 'Initials': 'TM', 'LastName': 'Ribeiro', 'Affiliation': 'Dentistry College, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Fabiana Soares Grecca', 'Initials': 'FSG', 'LastName': 'Vilella', 'Affiliation': 'Endodontic Division, Department of Conservative Dentistry, Federal University of Rio Grande do Sul, Rua Ramiro Barcelos, 2492 - Bairro Santana, Porto Alegre, RS, 90035-003, Brazil.'}, {'ForeName': 'Tiago André Fontoura', 'Initials': 'TAF', 'LastName': 'de Melo', 'Affiliation': 'Endodontic Division, Department of Conservative Dentistry, Federal University of Rio Grande do Sul, Rua Ramiro Barcelos, 2492 - Bairro Santana, Porto Alegre, RS, 90035-003, Brazil. tiago.melo@ufrgs.br.'}]",Clinical oral investigations,['10.1007/s00784-020-03390-6']
2853,32555432,Touching the social robot PARO reduces pain perception and salivary oxytocin levels.,"Human-human social touch improves mood and alleviates pain. No studies have so far tested the effect of human-robot emotional touch on experimentally induced pain ratings, on mood and on oxytocin levels in healthy young adults. Here, we assessed the effect of touching the robot PARO on pain perception, on mood and on salivary oxytocin levels, in 83 young adults. We measured their perceived pain, happiness state, and salivary oxytocin. For the 63 participants in the PARO group, pain was assessed in three conditions: Baseline, Touch (touching PARO) and No-Touch (PARO present). The control group (20 participants) underwent the same measurements without ever encountering PARO. There was a decrease in pain ratings and in oxytocin levels and an increase in happiness ratings compared to baseline only in the PARO group. The Touch condition yielded a larger decrease in pain ratings compared to No-Touch. These effects correlated with the participants' positive perceptions of the interaction with PARO. Participants with higher perceived ability to communicate with PARO experienced a greater hypoalgesic effect when touching PARO. We show that human-robot social touch is effective in reducing pain ratings, improving mood and - surprisingly - reducing salivary oxytocin levels in adults.",2020,There was a decrease in pain ratings and in oxytocin levels and an increase in happiness ratings compared to baseline only in the PARO group.,"['63 participants in the PARO group', 'adults', '83 young adults', 'healthy young adults']",['Human-human social touch'],"['salivary oxytocin levels', 'pain ratings and in oxytocin levels', 'mood and alleviates pain', 'perceived pain, happiness state, and salivary oxytocin', 'pain perception, on mood and on salivary oxytocin levels', 'pain', 'happiness ratings', 'pain ratings', 'pain perception and salivary oxytocin levels']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0152054', 'cui_str': 'Touch'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",83.0,0.0710033,There was a decrease in pain ratings and in oxytocin levels and an increase in happiness ratings compared to baseline only in the PARO group.,"[{'ForeName': 'Nirit', 'Initials': 'N', 'LastName': 'Geva', 'Affiliation': 'Recanati School for Community Health Professions, Department of Physical Therapy, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Florina', 'Initials': 'F', 'LastName': 'Uzefovsky', 'Affiliation': 'Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Levy-Tzedek', 'Affiliation': 'Recanati School for Community Health Professions, Department of Physical Therapy, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel. shelly@bgu.ac.il.'}]",Scientific reports,['10.1038/s41598-020-66982-y']
2854,32555582,Malleability of rumination: An exploratory model of CBT-based plasticity and long-term reduced risk for depressive relapse among youth from a pilot randomized clinical trial.,"CLINICAL TRIALS REGISTRATION


NCT01905267, https://clinicaltrials.gov/ct2/show/NCT01905267.",2020,"CLINICAL TRIALS REGISTRATION


NCT01905267, https://clinicaltrials.gov/ct2/show/NCT01905267.",[],[],[],[],[],[],,0.264659,"CLINICAL TRIALS REGISTRATION


NCT01905267, https://clinicaltrials.gov/ct2/show/NCT01905267.","[{'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Bessette', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, United States of America.'}, {'ForeName': 'Rachel H', 'Initials': 'RH', 'LastName': 'Jacobs', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, United States of America.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Heleniak', 'Affiliation': 'Department of Psychology, Columbia University, New York City, NY, United States of America.'}, {'ForeName': 'Amy T', 'Initials': 'AT', 'LastName': 'Peters', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States of America.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Welsh', 'Affiliation': 'Department of Psychiatry, University of Utah, Salt Lake City, UT, United States of America.'}, {'ForeName': 'Edward R', 'Initials': 'ER', 'LastName': 'Watkins', 'Affiliation': 'Mood Disorders Centre, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Langenecker', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, United States of America.'}]",PloS one,['10.1371/journal.pone.0233539']
2855,32555624,The consequences of exercise-induced weight loss on food reinforcement. A randomized controlled trial.,"BACKGROUND


Obesity remains a primary threat to the health of most Americans, with over 66% considered overweight or obese with a body mass index (BMI) of 25 kg/m2 or greater. A common treatment option many believe to be effective, and therefore turn to, is exercise. However, the amount of weight loss from exercise training is often disappointingly less than expected with greater amounts of exercise not always promoting greater weight loss. Increases in energy intake have been prescribed as the primary reason for this lack of weight loss success with exercise. Research has mostly focused on alterations in hormonal mediators of appetite (e.g.: ghrelin, peptide YY, GLP-1, pancreatic polypeptide, and leptin) that may increase hunger and/or reduce satiety to promote greater energy intake with exercise training. A less understood mechanism that may be working to increase energy intake with exercise is reward-driven feeding, a strong predictor of energy intake and weight status but rarely analyzed in the context of exercise.
DESIGN


Sedentary men and women (BMI: 25-35 kg/m2, N = 52) were randomized into parallel aerobic exercise training groups partaking in either two or six exercise sessions/week, or sedentary control for 12 weeks.
METHODS


The reinforcing value of food was measured by an operant responding progressive ratio schedule task (the behavioral choice task) to determine how much work participants were willing to perform for access to a healthy food option relative to a less healthy food option before and after the exercise intervention. Body composition and resting energy expenditure were assessed via DXA and indirect calorimetry, respectively, at baseline and post testing.
RESULTS


Changes in fat-free mass predicted the change in total amount of operant responding for food (healthy and unhealthy). There were no correlations between changes in the reinforcing value of one type of food (healthy vs unhealthy) to changes in body composition.
CONCLUSION


In support of previous work, reductions in fat-free mass resulting from an aerobic exercise intervention aimed at weight loss plays an important role in energy balance regulation by increasing operant responding for food.",2020,"There were no correlations between changes in the reinforcing value of one type of food (healthy vs unhealthy) to changes in body composition.
","['health of most Americans, with over 66% considered overweight or obese with a body mass index (BMI) of 25 kg/m2 or greater', 'BMI', 'N = 52', 'Sedentary men and women']","['aerobic exercise intervention', 'parallel aerobic exercise training groups partaking in either two or six exercise sessions/week, or sedentary control for 12 weeks']","['Body composition and resting energy expenditure', 'weight loss', 'total amount of operant responding for food (healthy and unhealthy']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]",52.0,0.0679676,"There were no correlations between changes in the reinforcing value of one type of food (healthy vs unhealthy) to changes in body composition.
","[{'ForeName': 'Kyle D', 'Initials': 'KD', 'LastName': 'Flack', 'Affiliation': 'Department of Dietetics and Human Nutrition, University of Kentucky, Lexington, Kentucky, United States of America.'}, {'ForeName': 'Harry M', 'Initials': 'HM', 'LastName': 'Hays', 'Affiliation': 'Department of Dietetics and Human Nutrition, University of Kentucky, Lexington, Kentucky, United States of America.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Moreland', 'Affiliation': 'Department of Dietetics and Human Nutrition, University of Kentucky, Lexington, Kentucky, United States of America.'}]",PloS one,['10.1371/journal.pone.0234692']
2856,32555681,Improving measles vaccine uptake rates in Nigeria: An RCT evaluating the impact of incentive sizes and reminder calls on vaccine uptake.,"OBJECTIVE


To assess the impact of increasing incentive size and reminder calls on the measles vaccine uptake rate.
DESIGN


Randomized controlled trial, randomized at individual level, stratified by clinic.
SETTING


Nigeria.
PARTICIPANTS


1088 caregivers with children aged nine months or older; had received at least one previous conditional cash transfer (CCT) at a program clinic, had received their Penta-3 immunization but had not yet received their measles immunization, and the caregiver had provided a phone number.
INTERVENTION


Nine clinics were randomized to two models; caregivers in Model 1 received a default of 2000 Nigerian Naira (NGN) for completing the measles vaccine, and those in Model 2 received by 3000 NGN. Caregivers from the respective clinics were then randomized to one of the four arms: 1) control (baseline amount of 2000 NGN or 3000 NGN), 2) baseline amount plus a reminder call, 3) baseline amount plus 1000 NGN and a reminder call, and 4) baseline amount plus 3000 NGN and a reminder call.
MAIN OUTCOME MEASURE


Receipt of measles vaccine as reported on a child health card.
RESULTS


Overall, there was no clear trend that increasing the incentive amount resulted in an increase in vaccine uptake rates. In Model 1 households, an additional 1000 NGN and 3000 NGN resulted in a 6.4 percentage point (95% CI: -2.3-15, p-value = 0.15) and 11.8 percentage point (95% CI: 3.9-19.6, p-value = 0.003) increase in the probability of completing the measles vaccines, respectively. This increase, however, was only significant for the 3000 NGN increase. On the other hand, in Model 2 households, increasing the incentive by 1000 NGN and 3000 NGN increased the probability by 3.3 (95% CI: -3.8-10.4, p-value = 0.36) and 3.3 (95% CI: -3.7-10.4, p-value = 0.35) percentage points. These increases were not statistically significant. Adding reminder calls to CCTs increased the probability of completing the measles vaccine; caregivers who received reminder calls plus CCTs were 5.1 percentage points more likely to get their children vaccinated (95% CI: 0.50-9.8, p-value = 0.03) compared to those who received CCTs and did not receive a reminder call. These results were largely driven by caregivers who went to clinics in Model 1.
CONCLUSION


A combination of increasing incentive amounts and reminder calls modestly improves measles immunization rates. However, this program also shows that there is substantial regional heterogeneity in response to both incentives and calls. While one possible conclusion is that a larger incentive and phone reminders are more likely to work in higher income and higher baseline coverage settings, the study is not designed to evaluate this claim. Rather, policymakers could consider experimenting with a similar low-cost calling study as part of the design of other cash transfer programs to identify whether adding reminder phone calls could increase the impact of the program.",2020,"NGN resulted in a 6.4 percentage point (95% CI: -2.3-15, p-value = 0.15) and 11.8 percentage point (95% CI: 3.9-19.6, p-value = 0.003) increase in the probability of completing the measles vaccines, respectively.","['Nigeria', '1088 caregivers with children aged nine months or older']","['least one previous conditional cash transfer (CCT) at a program clinic, had received their Penta-3 immunization but had not yet received their measles immunization, and the caregiver had provided a phone number', 'control (baseline amount of 2000 NGN or 3000 NGN), 2) baseline amount plus a reminder call, 3) baseline amount plus 1000 NGN and a reminder call, and 4) baseline amount plus 3000 NGN and a reminder call', 'vaccine', 'Model 1 received a default of 2000 Nigerian Naira (NGN) for completing the measles vaccine, and those in Model 2 received by 3000 NGN', 'CCTs']","['vaccine uptake rates', 'measles immunization rates']","[{'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0233535', 'cui_str': 'Butting'}, {'cui': 'C0025007', 'cui_str': 'Measles'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1515258', 'cui_str': 'Telephone number (property)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C1556089', 'cui_str': 'Nigerians'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0025010', 'cui_str': 'Measles vaccine'}, {'cui': 'C4049005', 'cui_str': 'Cataract, total congenital with posterior sutural opacities in Heterozygotes'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}]",9.0,0.319228,"NGN resulted in a 6.4 percentage point (95% CI: -2.3-15, p-value = 0.15) and 11.8 percentage point (95% CI: 3.9-19.6, p-value = 0.003) increase in the probability of completing the measles vaccines, respectively.","[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Brownstone', 'Affiliation': 'IDinsight, San Francisco, California, United States of America.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Connor', 'Affiliation': 'IDinsight, San Francisco, California, United States of America.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Stein', 'Affiliation': 'IDinsight, San Francisco, California, United States of America.'}]",PloS one,['10.1371/journal.pone.0233149']
2857,32555695,"Prognostic factors for changes in the timed 4-stair climb in patients with Duchenne muscular dystrophy, and implications for measuring drug efficacy: A multi-institutional collaboration.","The timed 4-stair climb (4SC) assessment has been used to measure function in Duchenne muscular dystrophy (DMD) practice and research. We sought to identify prognostic factors for changes in 4SC, assess their consistency across data sources, and the extent to which prognostic scores could be useful in DMD clinical trial design and analysis. Data from patients with DMD in the placebo arm of a phase 3 trial (Tadalafil DMD trial) and two real-world sources (Universitaire Ziekenhuizen, Leuven, Belgium [Leuven] and Cincinnati Children's Hospital Medical Center [CCHMC]) were analyzed. One-year changes in 4SC completion time and velocity (stairs/second) were analyzed. Prognostic models included age, height, weight, steroid use, and multiple timed function tests and were developed using multivariable regression, separately in each data source. Simulations were used to quantify impacts on trial sample size requirements. Data on 1-year changes in 4SC were available from the Tadalafil DMD trial (n = 92) Leuven (n = 67), and CCHMC (n = 212). Models incorporating multiple timed function tests, height, and weight significantly improved prognostic accuracy for 1-year change in 4SC (R2: 29%-36% for 4SC velocity, and 29%-34% for 4SC time) compared to models including only age, baseline 4SC and steroid duration (R2:8%-17% for 4SC velocity and 2%-13% for 4SC time). Measures of walking and rising ability contributed important prognostic information for changes in 4SC. In a randomized trial with equal allocation to treatment and placebo, adjustment for such a prognostic score would enable detection (at 80% power) of a treatment effect of 0.25 stairs/second with 100-120 patients, compared to 170-190 patients without prognostic score adjustment. Combining measures of ambulatory function doubled prognostic accuracy for 1-year changes in 4SC completion time and velocity. Randomized clinical trials incorporating a validated prognostic score could reduce sample size requirements by approximately 40%. Knowledge of important prognostic factors can also inform adjusted comparisons to external controls.",2020,"Models incorporating multiple timed function tests, height, and weight significantly improved prognostic accuracy for 1-year change in 4SC (R2: 29%-36% for 4SC velocity, and 29%-34% for 4SC time) compared to models including only age, baseline 4SC and steroid duration (R2:8%-17% for 4SC velocity and 2%-13% for 4SC time).","['patients with Duchenne muscular dystrophy', 'patients with DMD in the']",['placebo'],"['sample size requirements', '4SC completion time and velocity (stairs/second']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013264', 'cui_str': 'Duchenne muscular dystrophy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205436', 'cui_str': 'Second'}]",212.0,0.0551207,"Models incorporating multiple timed function tests, height, and weight significantly improved prognostic accuracy for 1-year change in 4SC (R2: 29%-36% for 4SC velocity, and 29%-34% for 4SC time) compared to models including only age, baseline 4SC and steroid duration (R2:8%-17% for 4SC velocity and 2%-13% for 4SC time).","[{'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Goemans', 'Affiliation': 'Department of Child Neurology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Wong', 'Affiliation': 'Department of Pediatrics, University of Massachusetts Medical School, Worcester, MA, United States of America.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Van den Hauwe', 'Affiliation': 'Department of Child Neurology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Signorovitch', 'Affiliation': 'Analysis Group Inc., Boston, Massachusetts, United States of America.'}, {'ForeName': 'Gautam', 'Initials': 'G', 'LastName': 'Sajeev', 'Affiliation': 'Analysis Group Inc., Boston, Massachusetts, United States of America.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cox', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, United States of America.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Landry', 'Affiliation': 'Eli Lilly and Company, Toronto, Ontario, Canada.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Jenkins', 'Affiliation': 'Analysis Group Inc., London, United Kingdom.'}, {'ForeName': 'Ibrahima', 'Initials': 'I', 'LastName': 'Dieye', 'Affiliation': 'Analysis Group Inc., Boston, Massachusetts, United States of America.'}, {'ForeName': 'Zhiwen', 'Initials': 'Z', 'LastName': 'Yao', 'Affiliation': 'Analysis Group Inc., Boston, Massachusetts, United States of America.'}, {'ForeName': 'Intekhab', 'Initials': 'I', 'LastName': 'Hossain', 'Affiliation': 'Analysis Group Inc., Boston, Massachusetts, United States of America.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Ward', 'Affiliation': 'The Collaborative Trajectory Analysis Project, Cambridge, Massachusetts, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0232870']
2858,30714833,Patient Preference to Accept Medical Treatment Is Associated with Spokesperson Agreement.,,2019,,[],[],[],[],[],[],,0.0149545,,"[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Foy', 'Affiliation': '1 Penn State College of Medicine Hershey, Pennsylvania.'}, {'ForeName': 'Benjamin H', 'Initials': 'BH', 'LastName': 'Levi', 'Affiliation': '1 Penn State College of Medicine Hershey, Pennsylvania.'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'Van Scoy', 'Affiliation': '1 Penn State College of Medicine Hershey, Pennsylvania.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Bucher', 'Affiliation': '1 Penn State College of Medicine Hershey, Pennsylvania.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Dimmock', 'Affiliation': '1 Penn State College of Medicine Hershey, Pennsylvania.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Green', 'Affiliation': '1 Penn State College of Medicine Hershey, Pennsylvania.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201806-428RL']
2859,30810273,Exploring infant signing to enhance responsive parenting: Findings from the INSIGHT study.,"Responsive parenting is a promising framework for obesity prevention, yet attempts to date have largely relied on parents accurately interpreting their child's cues. Infant signing or ""baby sign language"" could enhance these interventions by improving bidirectional parent-child communication during the preverbal and emerging language years. In a clinical trial testing, a responsive parenting intervention designed for obesity prevention, we pilot tested a brief intervention at age 40 weeks with a subset of participating dyads that taught the signing gesture of ""all done"" to improve parental recognition of satiety. In addition, we surveyed all participating mothers at child age 18 months on the use of infant signing gestures in the prior year. Two hundred twenty-eight mothers completed the survey including 72 responsive parenting group mothers that received the signing instructions. A majority of mothers, 63.6%, reported teaching their infant signs in the prior year, and 61.4% of infants were using signs to communicate at 18 months (median signs = 2). The signs for ""more"" and ""all done"" were used by over half of study participants and were the most common signs used. Other signs related to eating or drinking were commonly used. Signing intervention group infants were more likely to use the sign for ""all done"" than controls (63.9% vs. 45.5%; P = 0.01), but there was no difference between groups with regard to the use of the sign for ""more"" (56.9% vs. 51.3%; P = 0.43). Signing is commonly used by parents of young children and holds potential to improve parental responsiveness and obesity prevention efforts.",2019,"Signing intervention group infants were more likely to use the sign for ""all done"" than controls (63.9% vs. 45.5%; P = 0.01), but there was no difference between groups with regard to the use of the sign for ""more"" (56.9% vs. 51.3%; P = 0.43).","['participating mothers at child age 18\xa0months on the use of infant signing gestures in the prior year', 'Two hundred twenty-eight mothers completed the survey including 72 responsive parenting group mothers that received the']","['responsive parenting intervention', 'signing instructions']",[],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0017510', 'cui_str': 'Gestures'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]",[],,0.0364165,"Signing intervention group infants were more likely to use the sign for ""all done"" than controls (63.9% vs. 45.5%; P = 0.01), but there was no difference between groups with regard to the use of the sign for ""more"" (56.9% vs. 51.3%; P = 0.43).","[{'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Paul', 'Affiliation': 'Pediatrics, Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Hohman', 'Affiliation': 'Center for Childhood Obesity Research, Pennsylvania State University, University Park, Pennsylvania.'}, {'ForeName': 'Leann L', 'Initials': 'LL', 'LastName': 'Birch', 'Affiliation': 'Foods and Nutrition, University of Georgia, Athens, Georgia.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Shelly', 'Affiliation': 'Pediatrics, Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Claire D', 'Initials': 'CD', 'LastName': 'Vallotton', 'Affiliation': 'Human Development and Family Studies, Michigan State University, East Lansing, Michigan.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Savage', 'Affiliation': 'Center for Childhood Obesity Research, Pennsylvania State University, University Park, Pennsylvania.'}]",Maternal & child nutrition,['10.1111/mcn.12800']
2860,32556371,Multi-session anodal transcranial direct current stimulation enhances lower extremity functional performance in healthy older adults.,"The aim of this study was to examine the effects of 5 days of anodal-transcranial direct current stimulation (a-tDCS) over the primary motor cortex (M1) on lower extremity functional performance in healthy elderly people. This was a randomized, double-blinded, sham-controlled study whereby 32 healthy older individuals participated in two groups. The intervention group received 20 min of a-tDCS (1 mA) over the M1 on five consecutive days. The sham group received the same stimulation, but the tDCS device was turned off after 30 s of stimulation. Participants were asked to perform the Timed Up and Go (TUG), 30-s Chair Stand Test (30-s CST), and a Modified Figure of Eight Walk Test (MFEWT) on the first day before tDCS application, immediately, 30 min, and 1 week after the last session of stimulation. Results of the a-tDCS group showed that most of the test values had significant changes in post-test assessments compared to the pre-test (p < 0.05). When comparing the anodal and sham tDCS groups, the results showed a significant improvement in TUG and time-MFEWT immediately after (p = 0.02, p = 0.01), 30 min after (p = 0.04, p = 0.01) and 1 week after the last session of stimulation (p = 0.01, p = 0.01). Improvements in performance of the 30-s CST and the number of steps-MFEWT were not significant, except at 1 week after the last session for the steps-MFEWT (p = 0.04). The application of 20 min a-tDCS over the M1 for 5 consecutive days improves lower extremity functional performance in the healthy older participants.",2020,"Improvements in performance of the 30-s CST and the number of steps-MFEWT were not significant, except at 1 week after the last session for the steps-MFEWT (p = 0.04).","['32 healthy older individuals participated in two groups', 'healthy older adults', 'healthy elderly people', 'healthy older participants']","['20\xa0min of a-tDCS', 'primary motor cortex (M1', 'Multi-session anodal transcranial direct current stimulation', 'anodal-transcranial direct current stimulation (a-tDCS', 'Timed Up and Go (TUG), 30-s Chair Stand Test (30-s CST), and a Modified Figure of Eight Walk Test (MFEWT']","['number of steps-MFEWT', 'extremity functional performance', 'TUG and time-MFEWT']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",32.0,0.065157,"Improvements in performance of the 30-s CST and the number of steps-MFEWT were not significant, except at 1 week after the last session for the steps-MFEWT (p = 0.04).","[{'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Rostami', 'Affiliation': 'Department of Physiotherapy, Research Center on Aging, University of Social Welfare and Rehabilitation Sciences, Tehran, 1985713831, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mosallanezhad', 'Affiliation': 'Department of Physiotherapy, Research Center on Aging, University of Social Welfare and Rehabilitation Sciences, Tehran, 1985713831, Iran. zmosallanezhad@yahoo.com.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Ansari', 'Affiliation': 'Speech Therapy Department, Musculoskeletal Rehabilitation Research Center, Ahvaz Jundishapur University of Medical Science, Ahvaz, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Ehsani', 'Affiliation': 'Neuromuscular Rehabilitation Research Centre, Semnan University of Medical Science, Semnan, Iran.'}, {'ForeName': 'Dawson', 'Initials': 'D', 'LastName': 'Kidgell', 'Affiliation': 'Department of Physiotherapy, School of Primary Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Nourbakhsh', 'Affiliation': 'Department of Physical Therapy, University of North Georgia, Dahlonega, GA, USA.'}, {'ForeName': 'Enayatollah', 'Initials': 'E', 'LastName': 'Bakhshi', 'Affiliation': 'Department of Biostatistics, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Shapour', 'Initials': 'S', 'LastName': 'Jaberzadeh', 'Affiliation': 'Department of Physiotherapy, School of Primary Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}]",Experimental brain research,['10.1007/s00221-020-05827-6']
2861,32556437,Similar postoperative outcomes after total knee arthroplasty with measured resection and gap balancing techniques using a contemporary knee system: a randomized controlled trial.,"PURPOSE


The Attune® Knee System provides new instrumentation to achieve symmetric flexion/extension gaps in total knee arthroplasty (TKA). However, there is limited information on the optimal TKA technique using this system. The aim of this randomised controlled trial was to determine which surgical technique results in better postoperative clinical outcomes after TKA using the contemporary Attune ®  Knee System: the measured resection or gap balancing technique.
METHODS


A prospective randomized controlled trial was conducted with 100 patients undergoing TKA using measured resection (n = 50) or gap balancing (n = 50) technique. The measured femoral sizer was used in the measured resection group, while the balanced femoral sizer was used in the gap balancing group. Functional outcomes and quality of life were assessed preoperatively and at 6 months and 2 years post-surgery, using the Knee Society Function Score (KSFS), Knee Society Knee Score (KSKS), Oxford Knee Score (OKS), the Physical Component Score (PCS) and Mental Component Score (MCS) of Short-Form 36 (SF-36). Using weight-bearing coronal radiographs, the hip-knee-ankle angle (HKA), coronal femoral component angle (CFA), coronal tibial component angle (CTA) and joint line height were also evaluated for each patient.
RESULTS


There were no significant differences in the functional scores or the proportion of patients from each group who were satisfied or had their expectations fulfilled at 6 months or 2 years post-surgery. There was also no significant difference in the number of patients who attained minimum clinically important difference (MCID) postoperatively between the groups. Postoperatively, there was no significant difference in the number of HKA outliers between the groups (p = 0.202). The postoperative CFA (p = 0.265) and CTA (p = 0.479) were similar between the groups. There was also no significant difference in the absolute change (p = 0.447) or proportion of outliers (p = 0.611) for joint line height between the groups.
CONCLUSION


Both measured resection and gap balancing techniques resulted in comparable functional and quality of life outcomes up to 2 years post-surgery. Both techniques appear to be equally effective in achieving excellent outcomes with the Attune ®  Knee System.
LEVEL OF EVIDENCE


I.",2020,Both measured resection and gap balancing techniques resulted in comparable functional and quality of life outcomes up to 2 years post-surgery.,"['total knee arthroplasty (TKA', '100 patients undergoing']","['TKA using measured resection (n\u2009=\u200950) or gap balancing (n\u2009=\u200950) technique', 'total knee arthroplasty with measured resection and gap balancing techniques', 'TKA']","['femoral sizer', 'postoperative CFA', 'number of HKA outliers', 'functional scores', 'functional and quality of life outcomes', 'hip-knee-ankle angle (HKA), coronal femoral component angle (CFA), coronal tibial component angle (CTA) and joint line height', 'Functional outcomes and quality of life', 'Knee Society Function Score (KSFS), Knee Society Knee Score (KSKS), Oxford Knee Score (OKS), the Physical Component Score (PCS) and Mental Component Score (MCS) of Short-Form 36 (SF-36', 'joint line height']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0221872', 'cui_str': 'Sizer'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0449434', 'cui_str': 'Femoral component'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]",100.0,0.055071,Both measured resection and gap balancing techniques resulted in comparable functional and quality of life outcomes up to 2 years post-surgery.,"[{'ForeName': 'Vikaesh', 'Initials': 'V', 'LastName': 'Moorthy', 'Affiliation': 'Yong Loo Lin School of Medicine, National University Singapore, 1E Kent Ridge Road, NUHS Tower Block, Level 11, Singapore, 119228, Singapore. vikaeshmoorthy@yahoo.com.'}, {'ForeName': 'Mun Chun', 'Initials': 'MC', 'LastName': 'Lai', 'Affiliation': 'Department of Orthopaedic Surgery, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Ming Han Lincoln', 'Initials': 'MHL', 'LastName': 'Liow', 'Affiliation': 'Department of Orthopaedic Surgery, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Jerry Yongqiang', 'Initials': 'JY', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopaedic Surgery, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Hee Nee', 'Initials': 'HN', 'LastName': 'Pang', 'Affiliation': 'Department of Orthopaedic Surgery, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Shi-Lu', 'Initials': 'SL', 'LastName': 'Chia', 'Affiliation': 'Department of Orthopaedic Surgery, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Ngai Nung', 'Initials': 'NN', 'LastName': 'Lo', 'Affiliation': 'Department of Orthopaedic Surgery, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Seng Jin', 'Initials': 'SJ', 'LastName': 'Yeo', 'Affiliation': 'Department of Orthopaedic Surgery, Singapore General Hospital, Singapore, Singapore.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-020-06103-4']
2862,32556481,"Deep learning detection of prostate cancer recurrence with  18 F-FACBC (fluciclovine, Axumin®) positron emission tomography.","PURPOSE


To evaluate the performance of deep learning (DL) classifiers in discriminating normal and abnormal  18 F-FACBC (fluciclovine, Axumin®) PET scans based on the presence of tumor recurrence and/or metastases in patients with prostate cancer (PC) and biochemical recurrence (BCR).
METHODS


A total of 251 consecutive  18 F-fluciclovine PET scans were acquired between September 2017 and June 2019 in 233 PC patients with BCR (18 patients had 2 scans). PET images were labeled as normal or abnormal using clinical reports as the ground truth. Convolutional neural network (CNN) models were trained using two different architectures, a 2D-CNN (ResNet-50) using single slices (slice-based approach) and the same 2D-CNN and a 3D-CNN (ResNet-14) using a hundred slices per PET image (case-based approach). Models' performances were evaluated on independent test datasets.
RESULTS


For the 2D-CNN slice-based approach, 6800 and 536 slices were used for training and test datasets, respectively. The sensitivity and specificity of this model were 90.7% and 95.1%, and the area under the curve (AUC) of receiver operating characteristic curve was 0.971 (p < 0.001). For the case-based approaches using both 2D-CNN and 3D-CNN architectures, a training dataset of 100 images and a test dataset of 28 images were randomly allocated. The sensitivity, specificity, and AUC to discriminate abnormal images by the 2D-CNN and 3D-CNN case-based approaches were 85.7%, 71.4%, and 0.750 (p = 0.013) and 71.4%, 71.4%, and 0.699 (p = 0.053), respectively.
CONCLUSION


DL accurately classifies abnormal  18 F-fluciclovine PET images of the pelvis in patients with BCR of PC. A DL classifier using single slice prediction had superior performance over case-based prediction.",2020,A DL classifier using single slice prediction had superior performance over case-based prediction.,"['patients with BCR of PC', 'A total of 251 consecutive  18 F-fluciclovine PET scans were acquired between September 2017 and June 2019 in 233 PC patients with BCR (18 patients had 2 scans', 'patients with prostate cancer (PC) and biochemical recurrence (BCR']","['18 F-FACBC (fluciclovine, Axumin®) positron emission tomography']","['area under the curve (AUC) of receiver operating characteristic curve', 'sensitivity and specificity', 'sensitivity, specificity, and AUC', 'performance of deep learning (DL) classifiers']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0105421', 'cui_str': 'BCR protein, human'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0302995', 'cui_str': 'Fluorine-18'}, {'cui': 'C1311253', 'cui_str': 'fluciclovine F-18'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]","[{'cui': 'C0302995', 'cui_str': 'Fluorine-18'}, {'cui': 'C1311253', 'cui_str': 'fluciclovine F-18'}, {'cui': 'C4310336', 'cui_str': 'Axumin'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}]",28.0,0.0675701,A DL classifier using single slice prediction had superior performance over case-based prediction.,"[{'ForeName': 'Jong Jin', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'Division of Nuclear Medicine and Molecular Imaging, Department of Radiology, Stanford University, 300 Pasteur Dr, Stanford, CA, 94305, USA.'}, {'ForeName': 'Hongye', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'DimensionalMechanics Inc.®, Seattle, WA, USA.'}, {'ForeName': 'Benjamin L', 'Initials': 'BL', 'LastName': 'Franc', 'Affiliation': 'Division of Nuclear Medicine and Molecular Imaging, Department of Radiology, Stanford University, 300 Pasteur Dr, Stanford, CA, 94305, USA.'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Iagaru', 'Affiliation': 'Division of Nuclear Medicine and Molecular Imaging, Department of Radiology, Stanford University, 300 Pasteur Dr, Stanford, CA, 94305, USA.'}, {'ForeName': 'Guido A', 'Initials': 'GA', 'LastName': 'Davidzon', 'Affiliation': 'Division of Nuclear Medicine and Molecular Imaging, Department of Radiology, Stanford University, 300 Pasteur Dr, Stanford, CA, 94305, USA. gdavidzon@stanford.edu.'}]",European journal of nuclear medicine and molecular imaging,['10.1007/s00259-020-04912-w']
2863,32556659,"Effectiveness of a nutraceutical agent in the non-surgical periodontal therapy: a randomized, controlled clinical trial.","OBJECTIVE


Nutraceutical agents have been demonstrated as adjuncts for the treatment of several inflammatory diseases. The present study analyzed and compared new nutraceutical agent as an adjunct to Scaling and root planing (SRP) versus SRP alone for the treatment of periodontitis.
MATERIALS AND METHODS


Sixty-six patients with moderate periodontitis were enrolled. Through a randomized design, the patients were randomly assigned to SRP + nutraceutical agent (test group) or SRP alone (control group). Patients were regularly examined the clinical, inflammatory mediators and visual analogue scale (VAS) changes over a 6-month period. Clinical attachment level (CAL) was the primary outcome variable chosen. Gingival crevicular fluid (GCF) inflammatory mediator change and the impact of treatment on VAS were evaluated through a linear regression model.
RESULTS


Both treatments demonstrated an improvement in periodontal parameters compared with baseline. After 6 months of treatment, compared with the control group, the test group determined a significant probing depth (PD) (p = 0.003) and bleeding on probing (BOP) reduction (p < 0.001), while CAL gain was significantly obtained at 30 and 60 days after treatment (p < 0.05). In the test group, the level of inflammatory mediators was significantly reduced compared with the control group (p < 0.05). The linear regression analysis demonstrated that the nutraceutical agent exerted, in the test group, a significant influence on VAS at 6, 12, 24, and 48 h after treatment (p < 0.05).
CONCLUSIONS


Nutraceutical agent resulted in a more significant reduction in clinical, inflammatory mediators and short-term pain compared with SRP alone.
CLINICAL RELEVANCE


Nutraceutical agent, when combined with SRP, was demonstrated to be effective in reducing periodontal parameters and controlling the levels of inflammatory mediators and pain in patients with periodontitis.",2020,"In the test group, the level of inflammatory mediators was significantly reduced compared with the control group (p < 0.05).","['Sixty-six patients with moderate periodontitis were enrolled', 'patients with periodontitis']","['nutraceutical agent', 'SRP + nutraceutical agent (test group) or SRP alone (control group', 'Scaling and root planing (SRP) versus SRP alone']","['level of inflammatory mediators', 'CAL gain', 'significant probing depth (PD', 'bleeding on probing (BOP) reduction', 'periodontal parameters', 'clinical, inflammatory mediators and visual analogue scale (VAS) changes', 'VAS', 'Gingival crevicular fluid (GCF) inflammatory mediator change', 'clinical, inflammatory mediators and short-term pain', 'Clinical attachment level (CAL']","[{'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}]","[{'cui': 'C1518478', 'cui_str': 'Nutriceuticals'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",66.0,0.054188,"In the test group, the level of inflammatory mediators was significantly reduced compared with the control group (p < 0.05).","[{'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Isola', 'Affiliation': 'Department of General Surgery and Surgical-Medical Specialties, University of Catania, Via S. Sofia 78, 95123, Catania, Italy. gaetano.isola@unict.it.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Polizzi', 'Affiliation': 'Department of General Surgery and Surgical-Medical Specialties, University of Catania, Via S. Sofia 78, 95123, Catania, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Iorio-Siciliano', 'Affiliation': 'Department of Neurosciences, Reproductive and Odontostomatological Sciences, School of Medicine, University of Naples ""Federico II"", Via G. Pansini 5, 80131, Naples, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Alibrandi', 'Affiliation': 'Department of Economics, Unit of Statistical and Mathematical Sciences, University of Messina, Piazza Pugliatti 1, Messina, 98123, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Ramaglia', 'Affiliation': 'Department of Neurosciences, Reproductive and Odontostomatological Sciences, School of Medicine, University of Naples ""Federico II"", Via G. Pansini 5, 80131, Naples, Italy.'}, {'ForeName': 'Rosalia', 'Initials': 'R', 'LastName': 'Leonardi', 'Affiliation': 'Department of General Surgery and Surgical-Medical Specialties, University of Catania, Via S. Sofia 78, 95123, Catania, Italy.'}]",Clinical oral investigations,['10.1007/s00784-020-03397-z']
2864,32556683,Is There Still a Role for Aspirin in Primary Prevention in Women in 2020?,"PURPOSE OF REVIEW


Aspirin's place in primary prevention for females has not been well delineated and has been under increased scrutiny in light of recent literature and guideline recommendations. The purpose of this review is to discuss current literature reviewing aspirin use for primary prevention in women and to discuss when use is appropriate.
RECENT FINDINGS


The Women's Health Study found no differences in major adverse cardiovascular events (MACE) in women randomized to aspirin vs. placebo, though a significant reduction was observed in women ≥ 65 years. More recent literature evaluated outcomes for primary prevention use in patients at increased cardiovascular risk, patients with diabetes, and patients who are elderly. These trials found either no benefit in MACE outcomes or a slight benefit accompanied by an increased risk of bleeding. Furthermore, no difference in outcomes were found in subgroup analyses comparing females receiving aspirin vs. placebo or comparing events in males vs. females. With improvements in risk factor reduction, such as blood pressure control, statin use, diabetes management, and smoking cessation, the role of aspirin for primary prevention in women is still uncertain. Aspirin use for primary prevention in females has failed to show a clear benefit except in women ≥ 65 years old, with a potential increase in bleeding events. An effort to better study aspirin in female patients would allow for better identification of women who would or would not benefit from therapy.",2020,"The Women's Health Study found no differences in major adverse cardiovascular events (MACE) in women randomized to aspirin vs. placebo, though a significant reduction was observed in women ≥ ",['female patients'],"['Aspirin', 'aspirin vs. placebo', 'aspirin']","['cardiovascular risk', 'major adverse cardiovascular events (MACE', 'risk of bleeding', 'bleeding events', 'blood pressure control, statin use, diabetes management, and smoking cessation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]",,0.0357351,"The Women's Health Study found no differences in major adverse cardiovascular events (MACE) in women randomized to aspirin vs. placebo, though a significant reduction was observed in women ≥ ","[{'ForeName': 'Elisabeth M', 'Initials': 'EM', 'LastName': 'Sulaica', 'Affiliation': 'Department of Pharmacy Practice and Translational Research, University of Houston College of Pharmacy, 4849 Calhoun Road Health 2, Room 3044, Houston, TX, 77204-5039, USA. emsulaic@central.uh.edu.'}, {'ForeName': 'Bernadette D', 'Initials': 'BD', 'LastName': 'Asias-Dinh', 'Affiliation': 'Department of Pharmacy Practice and Translational Research, University of Houston College of Pharmacy, 4849 Calhoun Road Health 2, Room 3044, Houston, TX, 77204-5039, USA.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Wanat', 'Affiliation': 'Department of Pharmacy Practice and Translational Research, University of Houston College of Pharmacy, 4849 Calhoun Road Health 2, Room 3044, Houston, TX, 77204-5039, USA.'}, {'ForeName': 'Kim K', 'Initials': 'KK', 'LastName': 'Birtcher', 'Affiliation': 'Department of Pharmacy Practice and Translational Research, University of Houston College of Pharmacy, 4849 Calhoun Road Health 2, Room 3044, Houston, TX, 77204-5039, USA.'}]",Current atherosclerosis reports,['10.1007/s11883-020-00851-x']
2865,32556699,Low-pressure pneumoperitoneum with deep neuromuscular blockade in metabolic surgery to reduce postoperative pain: a randomized pilot trial.,"BACKGROUND


For metabolic laparoscopic surgery, higher pressures up to 20 mmHg are often used to create a surgical field of sufficient quality. This randomized pilot study aimed to determine the feasibility, safety and tolerability of low intraabdominal pressure (IAP) and deep neuromuscular blockade (NMB) to reduce postoperative pain.
METHODS


In a teaching hospital in the Netherlands, 62 patients eligible for a laparoscopic Roux-en-Y gastric bypass (LRYGB) were randomized into one of four groups in a 2 × 2 factorial design: deep/moderate NMB and standard (20 mmHg)/low IAP (12 mmHg). Patient and surgical team were blinded. Primary outcome measure was the surgical field quality, scored on the Leiden-Surgical Rating Scale (L-SRS). Secondary outcome measures were (serious) adverse events, duration of surgery and postoperative pain.
RESULTS


62 patients were included. L-SRS was good or perfect in all patients that were operated under standard IAP with deep or moderate NMB. In 40% of patients with low IAP and deep NMB, an increase in IAP was needed to improve surgical overview. In patients with low IAP and moderate NMB, IAP was increased to improve surgical overview in 40%, and in 75% of these cases a deep NMB was requested to further improve the surgical overview. Median duration of surgery was 38 min (IQR34-40 min) in the group with standard IAP and moderate NMB and 52 min (IQR46-55 min) in the group with low IAP and deep NMB.
CONCLUSIONS


The combination of moderate NMB and low IAP can create insufficient surgical overview. Larger trials are needed to corroborate the findings of this study.
TRIAL REGISTRATION


Dutch Trial Register: Trial NL7050, registered 28 May 2018. https://www.trialregister.nl/trial/7050.",2020,L-SRS was good or perfect in all patients that were operated under standard IAP with deep or moderate NMB.,"['62 patients were included', '62 patients eligible for a laparoscopic Roux-en-Y gastric bypass (LRYGB']","['low intraabdominal pressure (IAP) and deep neuromuscular blockade (NMB', 'moderate NMB and standard (20\xa0mmHg)/low', 'Low-pressure pneumoperitoneum with deep neuromuscular blockade']","['Median duration of surgery', 'IAP', 'postoperative pain', 'surgical overview', 'serious) adverse events, duration of surgery and postoperative pain', 'surgical field quality, scored on the Leiden-Surgical Rating Scale (L-SRS', 'feasibility, safety and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0231901', 'cui_str': 'Intraabdominal pressure'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0234119', 'cui_str': 'Neuromuscular blockade'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0231901', 'cui_str': 'Intraabdominal pressure'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",62.0,0.183559,L-SRS was good or perfect in all patients that were operated under standard IAP with deep or moderate NMB.,"[{'ForeName': 'Marjolijn', 'Initials': 'M', 'LastName': 'Leeman', 'Affiliation': 'Department of Surgery, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045 PM, Rotterdam, The Netherlands. M.Leeman@Franciscus.nl.'}, {'ForeName': 'L Ulas', 'Initials': 'LU', 'LastName': 'Biter', 'Affiliation': 'Department of Surgery, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045 PM, Rotterdam, The Netherlands.'}, {'ForeName': 'Jan A', 'Initials': 'JA', 'LastName': 'Apers', 'Affiliation': 'Department of Surgery, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045 PM, Rotterdam, The Netherlands.'}, {'ForeName': 'Erwin', 'Initials': 'E', 'LastName': 'Birnie', 'Affiliation': 'Department of Statistics and Education, Franciscus Gasthuis & Vlietland, Rotterdam, The Netherlands.'}, {'ForeName': 'Serge J C', 'Initials': 'SJC', 'LastName': 'Verbrugge', 'Affiliation': 'Department of Anesthesiology, Franciscus Gasthuis & Vlietland, Rotterdam, The Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Dunkelgrun', 'Affiliation': 'Department of Surgery, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045 PM, Rotterdam, The Netherlands.'}]",Surgical endoscopy,['10.1007/s00464-020-07719-w']
2866,32556709,Comparing Effectiveness of HRV-Biofeedback and Mindfulness for Workplace Stress Reduction: A Randomized Controlled Trial.,"Psychophysiological disorders due to work-related stress continue to be highly costly for health systems and approaches for cost-effective and easily accessible interventions are much needed. Both heart rate variability-biofeedback (HRV-Bfb) and mindfulness-based interventions (MBI) have been empirically shown to reduce stress. This study compares these two interventions in the work context to a wait-list-control-group (WLC). In this three-armed randomized controlled trial (RCT), 69 healthy adults employed in the same organization were randomized to participate in HRV-Bfb, MBI or the WLC. Participants were assessed for psychophysiological parameters of stress (stress perception, coping, HRV parameters and cortisol) and stress related symptoms (depressive symptoms, psychological wellbeing, mindfulness and self-compassion). Participants trained using either HRV-Bfb or MBI for 6 weeks on a daily basis. Outcomes were assessed at baseline, after the intervention and at follow-up 12 weeks later. Results did not show any statistically significant differences between HRV-Bfb and MBI groups, and neither of the intervention groups (IGs) differed from the WLC. Findings suggest an overall reduction in stress for all groups, including the WLC, with mostly small to medium effect sizes. However, it is important to note that participants with higher baseline stress levels might benefit more from mindfulness and biofeedback-based stress reduction interventions. The results have to be interpreted with caution due to the relatively small sample size. MBI might have a slightly stronger effect on stress reduction in comparison to HRV-Bfb, as suggested by the effect sizes. This study highlights issues and challenges of the implementation of such interventions in corporate health management.",2020,"Findings suggest an overall reduction in stress for all groups, including the WLC, with mostly small to medium effect sizes.","['69 healthy adults employed in the same organization', 'Workplace Stress Reduction']","['HRV-Biofeedback and Mindfulness', 'HRV-Bfb, MBI or the WLC', 'HRV-Bfb or MBI', 'biofeedback (HRV-Bfb) and mindfulness-based interventions (MBI', 'wait-list-control-group (WLC']","['psychophysiological parameters of stress (stress perception, coping, HRV parameters and cortisol) and stress related symptoms (depressive symptoms, psychological wellbeing, mindfulness and self-compassion']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}]",69.0,0.0342822,"Findings suggest an overall reduction in stress for all groups, including the WLC, with mostly small to medium effect sizes.","[{'ForeName': 'Amelie Edith', 'Initials': 'AE', 'LastName': 'Brinkmann', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, University of Tuebingen, 72070, Tübingen, Germany. amelie.brinkmann@uni-tuebingen.de.'}, {'ForeName': 'Sophia Antonia', 'Initials': 'SA', 'LastName': 'Press', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, University of Tuebingen, 72070, Tübingen, Germany.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Helmert', 'Affiliation': 'ARCIM Institute for Academic Research in Complementary and Integrative Medicine, 70794, Filderstadt, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hautzinger', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, University of Tuebingen, 72070, Tübingen, Germany.'}, {'ForeName': 'Inna', 'Initials': 'I', 'LastName': 'Khazan', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Vagedes', 'Affiliation': 'ARCIM Institute for Academic Research in Complementary and Integrative Medicine, 70794, Filderstadt, Germany. j.vagedes@arcim-institute.de.'}]",Applied psychophysiology and biofeedback,['10.1007/s10484-020-09477-w']
2867,32556768,A prospective randomized controlled trial of omeprazole for preventing esophageal stricture in grade 2b and 3a corrosive esophageal injuries.,"OBJECTIVES


Esophageal stricture is a significant complication of grade 2b and 3a esophageal injuries and causes much patient suffering. Preventing strictures would be beneficial to patients but there are currently no proven effective drugs. This study aimed to evaluate the effect of omeprazole for preventing esophageal stricture in adults with grade 2b and 3a corrosive esophageal injuries.
METHODS


This study was an open single-center prospective randomized controlled trial that took place from April 2018 to January 2020. Patients were randomized to standard treatment or 80 mg/day intravenously × 3 days followed by 40 mg/day orally for 4 weeks. They were endoscoped at baseline and 4 weeks post discharge. Strictures were confirmed radiologically.
RESULTS


20 patients were enrolled: 15 with grade 2b and five with grade 3a injuries. Standard care and omeprazole groups numbered 10 each. At 1 month, seven and two patients developed strictures in the standard and omeprazole groups, respectively, p = 0.024, for a risk reduction of 71.4%.
CONCLUSIONS


Omeprazole reduced the risk of short-term developing esophageal strictures following grade 2b and 3a corrosive esophageal injuries. Larger studies are needed to reconfirm this finding. Thai Clinical Trials Registry (TCTR) number TCTR20190504001.",2020,"At 1 month, seven and two patients developed strictures in the standard and omeprazole groups, respectively, p = 0.024, for a risk reduction of 71.4%.
","['adults with grade 2b and 3a corrosive esophageal injuries', 'esophageal stricture in grade 2b and 3a corrosive esophageal injuries', '20 patients were enrolled: 15 with grade 2b and five with grade 3a injuries', 'took place from April 2018 to January 2020']","['omeprazole', 'Omeprazole']","['esophageal stricture', 'strictures', 'risk of short-term developing esophageal strictures']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0524525', 'cui_str': 'Corrosives'}, {'cui': 'C0267096', 'cui_str': 'Esophageal injury'}, {'cui': 'C4551650', 'cui_str': 'Stricture of esophagus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0028978', 'cui_str': 'Omeprazole'}]","[{'cui': 'C4551650', 'cui_str': 'Stricture of esophagus'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",20.0,0.050334,"At 1 month, seven and two patients developed strictures in the standard and omeprazole groups, respectively, p = 0.024, for a risk reduction of 71.4%.
","[{'ForeName': 'Prasit', 'Initials': 'P', 'LastName': 'Mahawongkajit', 'Affiliation': 'Department of Surgery, Faculty of Medicine, Thammasat University (Rangsit Campus), 99/209 Moo 18, Paholyothin Road, Amphur Klongluang, Pathumthani, 12120, Thailand. prasit_md@yahoo.com.'}, {'ForeName': 'Prakitpunthu', 'Initials': 'P', 'LastName': 'Tomtitchong', 'Affiliation': 'Department of Surgery, Faculty of Medicine, Thammasat University (Rangsit Campus), 99/209 Moo 18, Paholyothin Road, Amphur Klongluang, Pathumthani, 12120, Thailand.'}, {'ForeName': 'Nuttorn', 'Initials': 'N', 'LastName': 'Boochangkool', 'Affiliation': 'Department of Surgery, Faculty of Medicine, Thammasat University (Rangsit Campus), 99/209 Moo 18, Paholyothin Road, Amphur Klongluang, Pathumthani, 12120, Thailand.'}, {'ForeName': 'Chatchai', 'Initials': 'C', 'LastName': 'Mingmalairak', 'Affiliation': 'Department of Surgery, Faculty of Medicine, Thammasat University (Rangsit Campus), 99/209 Moo 18, Paholyothin Road, Amphur Klongluang, Pathumthani, 12120, Thailand.'}, {'ForeName': 'Surajit', 'Initials': 'S', 'LastName': 'Awsakulsutthi', 'Affiliation': 'Department of Surgery, Faculty of Medicine, Thammasat University (Rangsit Campus), 99/209 Moo 18, Paholyothin Road, Amphur Klongluang, Pathumthani, 12120, Thailand.'}, {'ForeName': 'Chittinad', 'Initials': 'C', 'LastName': 'Havanond', 'Affiliation': 'Department of Surgery, Faculty of Medicine, Thammasat University (Rangsit Campus), 99/209 Moo 18, Paholyothin Road, Amphur Klongluang, Pathumthani, 12120, Thailand.'}]",Surgical endoscopy,['10.1007/s00464-020-07707-0']
2868,32556769,"A three-arm randomized study to compare sexual functions and fertility indices following open mesh hernioplasty (OMH), laparoscopic totally extra peritoneal (TEP) and transabdominal preperitoneal (TAPP) repair of groin hernia.","BACKGROUND


With evolving technology, the focus of groin hernia repair has shifted to sexual function and fertility outcomes.
METHODS


This three-arm randomized study was conducted in tertiary care hospital from 1st July 2017 to 30th March 2019. Consecutive patients of groin hernia were randomized into 3 groups, TAPP (Group 1), TEP (Group 2), and OMH (Group 3). Demographic profile and hernia characteristics were assessed preoperatively. Sexual functions (using BMSFI) and fertility (using surrogate fertility indices, viz., semen analysis and anti-sperm antibodies (ASA)) were assessed preoperatively at 3 months after the surgery.
RESULTS


A total of 121 patients were included in the study with 41 patients in TAPP (Group 1) and 40 each in TEP (Group 2) and OMH (Group3) group. All the 3 groups were comparable in terms of demographic profile, hernia characteristics, intra-operative and early post-operative outcomes. Significant improvement was found in most of the domains of BMSFI score in the study population (p value < 0.001) with no intergroup difference. There was significant increase of anti-sperm antibody level in OMH group as compared to TAPP and TEP (p = 0.001), however, the levels were within normal limit.
CONCLUSIONS


In conclusion, this study has shown that inguinal hernia repair whether open or laparoscopic (TEP or TAPP) leads on to improvement in sexual functions and fertility indices and can have a significant impact on pre-op counseling of the patient in terms of choice of repair, depending on the available expertise in a given center.",2020,"There was significant increase of anti-sperm antibody level in OMH group as compared to TAPP and TEP (p = 0.001), however, the levels were within normal limit.
","['tertiary care hospital from 1st July 2017 to 30th March 2019', 'Consecutive patients of groin hernia', 'A total of 121 patients were included in the study with 41 patients in TAPP (Group 1) and 40 each in TEP (Group 2) and OMH (Group3) group']","['TAPP', 'inguinal hernia repair whether open or laparoscopic (TEP or TAPP', 'TEP', 'OMH', 'open mesh hernioplasty (OMH), laparoscopic totally extra peritoneal (TEP) and transabdominal preperitoneal (TAPP) repair of groin hernia']","['Demographic profile and hernia characteristics', 'BMSFI score', 'sexual functions and fertility indices', 'Sexual functions (using BMSFI) and fertility (using surrogate fertility indices, viz., semen analysis and anti-sperm antibodies (ASA', 'anti-sperm antibody level', 'demographic profile, hernia characteristics, intra-operative and early post-operative outcomes']","[{'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0163807', 'cui_str': 'tetra-4-amidinophenoxypropane'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0145334', 'cui_str': 'tetraethylpyrazine'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0163807', 'cui_str': 'tetra-4-amidinophenoxypropane'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0145334', 'cui_str': 'tetraethylpyrazine'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0019328', 'cui_str': 'Hernia repair'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0205496', 'cui_str': 'Abdominal approach'}, {'cui': 'C0442170', 'cui_str': 'Preperitoneal approach'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0202533', 'cui_str': 'Semen analysis'}, {'cui': 'C0201527', 'cui_str': 'Antibody to spermatozoa measurement'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",121.0,0.0883522,"There was significant increase of anti-sperm antibody level in OMH group as compared to TAPP and TEP (p = 0.001), however, the levels were within normal limit.
","[{'ForeName': 'Shardool', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Department of Surgical Disciplines, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Asuri', 'Initials': 'A', 'LastName': 'Krishna', 'Affiliation': 'Department of Surgical Disciplines, All India Institute of Medical Sciences, New Delhi, India. dr.asurikrishna@gmail.com.'}, {'ForeName': 'Mayank', 'Initials': 'M', 'LastName': 'Jain', 'Affiliation': ''}, {'ForeName': 'Ankur', 'Initials': 'A', 'LastName': 'Goyal', 'Affiliation': 'Department of Radio Diagnosis, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Atin', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Department of Radio Diagnosis, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Chaturvedi', 'Affiliation': 'Department of Reproductive Biology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Sagar', 'Affiliation': 'Department of Psychiatry, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rashmi', 'Initials': 'R', 'LastName': 'Ramachandran', 'Affiliation': 'Department of Anesthesiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Om', 'Initials': 'O', 'LastName': 'Prakash', 'Affiliation': 'Department of Surgical Disciplines, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Department of Surgical Disciplines, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Seenu', 'Affiliation': 'Department of Surgical Disciplines, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Virinder', 'Initials': 'V', 'LastName': 'Bansal', 'Affiliation': 'Department of Surgical Disciplines, All India Institute of Medical Sciences, New Delhi, India.'}]",Surgical endoscopy,['10.1007/s00464-020-07697-z']
2869,32556821,Comparison of Two Specialized Histology Needles for Endoscopic Ultrasound (EUS)-Guided Liver Biopsy: A Pilot Study.,"BACKGROUND


EUS-guided liver biopsy (EUS-LB) has been shown to be a safe and effective alternative to percutaneous liver biopsy. The optimal needle device and technique for EUS-LB is still evolving. The aim of this study was to compare the efficacy of two second-generation 19G fine-needle biopsy (FNB) (Franseen- and Fork-tip) devices for EUS-LB.
METHODS


This is a repeated-measure crossover study with a prospectively maintained cohort of patients. We performed EUS-LB with a one-pass and single-actuation method using two 19G FNB needles in 22 consecutive patients between 10/2018 and 9/2019. Patients were randomized to left vs right liver lobes to be biopsied as well as the needle sequence. The specimens obtained were evaluated for adequacy for histologic diagnosis. The primary outcome was number of complete portal tracts (CPTs), post-fix aggregate, and longest specimen length. Secondary outcomes were prefix aggregate specimen length and the specimen adequacy judged by two expert pathologists.
RESULTS


A total of 44 liver biopsies were performed in 22 patients. The CPTs were higher in the Franseen-tip needle group compared to the Fork-tip needle group (14.4 vs 9.5, p = 0.043). Post-fix aggregate specimen length (44.9 mm vs 34.6 mm, p = 0.097), the post-fix longest specimen length (19.9 mm vs 13.7 mm, p = 0.175), and prefix aggregate specimen length (51.7 mm vs 45 mm, p = 0.265) were not significantly different. Both needles showed similarly high histologic adequacy (100% vs 95.5%, p = 0.312). Interestingly, the right of the liver showed higher yield of CPTs with both needles (Franseen, 16.2 vs. 12.8, p = 0.003, the Fork-tip, 12.8 vs. 7.0, p < 0.0001).
CONCLUSION


EUS-guided liver biopsy using the 19G Franseen-tip needle may provide more CPTs than 19G Fork-tip needle on a single-pass, single-actuation comparison.",2020,"Post-fix aggregate specimen length (44.9 mm vs 34.6 mm, p = 0.097), the post-fix longest specimen length (19.9 mm vs 13.7 mm, p = 0.175), and prefix aggregate specimen length (51.7 mm vs 45 mm, p = 0.265) were not significantly different.","['44 liver biopsies were performed in 22 patients', '22 consecutive patients between 10/2018 and 9/2019']","['Two Specialized Histology Needles for Endoscopic Ultrasound (EUS)-Guided Liver Biopsy', 'EUS-guided liver biopsy (EUS-LB', 'two second-generation 19G fine-needle biopsy (FNB) (Franseen- and Fork-tip']","['CPTs', 'histologic adequacy', 'post-fix longest specimen length', 'prefix aggregate specimen length', 'number of complete portal tracts (CPTs), post-fix aggregate, and longest specimen length', 'prefix aggregate specimen length and the specimen adequacy judged by two expert pathologists']","[{'cui': 'C0193388', 'cui_str': 'Biopsy of liver'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0193388', 'cui_str': 'Biopsy of liver'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0470539', 'cui_str': '19G'}, {'cui': 'C0085846', 'cui_str': 'Fine needle biopsy'}, {'cui': 'C0546910', 'cui_str': 'Fork'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032717', 'cui_str': 'Portal tract structure'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205418', 'cui_str': 'Aggregate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0221191', 'cui_str': 'Judge'}, {'cui': 'C0334866', 'cui_str': 'Medical pathologist'}]",22.0,0.0255217,"Post-fix aggregate specimen length (44.9 mm vs 34.6 mm, p = 0.097), the post-fix longest specimen length (19.9 mm vs 13.7 mm, p = 0.175), and prefix aggregate specimen length (51.7 mm vs 45 mm, p = 0.265) were not significantly different.","[{'ForeName': 'Rintaro', 'Initials': 'R', 'LastName': 'Hashimoto', 'Affiliation': 'Division of Gastroenterology and Hepatology, H. H. Chao Comprehensive Digestive Disease Center, University of California, Irvine Medical Center, Orange, CA, 92868, USA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Lee', 'Affiliation': 'Division of Gastroenterology and Hepatology, H. H. Chao Comprehensive Digestive Disease Center, University of California, Irvine Medical Center, Orange, CA, 92868, USA.'}, {'ForeName': 'Jason B', 'Initials': 'JB', 'LastName': 'Samarasena', 'Affiliation': 'Division of Gastroenterology and Hepatology, H. H. Chao Comprehensive Digestive Disease Center, University of California, Irvine Medical Center, Orange, CA, 92868, USA.'}, {'ForeName': 'Vishal S', 'Initials': 'VS', 'LastName': 'Chandan', 'Affiliation': 'Pathology Department, University of California, Irvine Medical Center, Orange, CA, 92868, USA.'}, {'ForeName': 'Wenchang', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': 'Pathology Department, University of California, Irvine Medical Center, Orange, CA, 92868, USA.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Lee', 'Affiliation': 'Division of Gastroenterology and Hepatology, H. H. Chao Comprehensive Digestive Disease Center, University of California, Irvine Medical Center, Orange, CA, 92868, USA.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Chang', 'Affiliation': 'Division of Gastroenterology and Hepatology, H. H. Chao Comprehensive Digestive Disease Center, University of California, Irvine Medical Center, Orange, CA, 92868, USA. kchang@hs.uci.edu.'}]",Digestive diseases and sciences,['10.1007/s10620-020-06391-3']
2870,32556834,Believing in Make-Believe: Efficacy of a Pretend Play Intervention for School-Aged Children with High-Functioning Autism Spectrum Disorder.,"Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder marked by socio-emotional deficits, and difficulties with pretend play skills. Play skills are related to processes of adaptive functioning and emotion understanding. The present pilot study implemented an in-person pretend play intervention to school-aged children (ages 6 to 9 years, intervention group = 18, control group = 7) diagnosed with high-functioning ASD (HF-ASD), to increase children's cognitive and affective play skills, and emotional understanding abilities. The intervention consisted of 5 weekly sessions, 15-20 minutes each. The intervention group significantly increased in imagination and cognitive play skills, which generalized to increased skills in emotional understanding. Findings demonstrate the positive impact of a short, easily facilitated, accessible play intervention for school-aged children with HF-ASD.",2020,"The intervention group significantly increased in imagination and cognitive play skills, which generalized to increased skills in emotional understanding.","['school-aged children with HF-ASD', 'School-Aged Children with High-Functioning Autism Spectrum Disorder', 'to school-aged children (ages 6 to 9\xa0years', 'Autism Spectrum Disorder (ASD']","['Pretend Play Intervention', 'intervention group\u2009=\u200918, control group\u2009=\u20097) diagnosed with high-functioning ASD (HF-ASD', 'person pretend play intervention']","[""children's cognitive and affective play skills, and emotional understanding abilities"", 'imagination and cognitive play skills, which generalized to increased skills in emotional understanding']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C3840214', 'cui_str': 'High-functioning autism'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3840214', 'cui_str': 'High-functioning autism'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0020913', 'cui_str': 'Use of imagination'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",,0.041852,"The intervention group significantly increased in imagination and cognitive play skills, which generalized to increased skills in emotional understanding.","[{'ForeName': 'Ellen A', 'Initials': 'EA', 'LastName': 'Doernberg', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, USA. ellen.doernberg@case.edu.'}, {'ForeName': 'Sandra W', 'Initials': 'SW', 'LastName': 'Russ', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Dimitropoulos', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, USA.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04547-8']
2871,32550739,Intravaginal isonicotinic acid hydrazide (INH) versus misoprostol for cervical ripening prior to hysteroscopy.,"Objective


The aim of the present study was to compare the efficacy of vaginal isoniazid (isonicotinic acid hydrazide [INH]) and vaginal misoprostol in cervical ripening before hysteroscopic surgery.
Methods


This randomized controlled trial included patients scheduled for hysteroscopic surgery during April 2016 and June 2017. The inclusion criteria were as follows: postmenopausal women or those at premenopausal age who had not had a vaginal delivery and candidate for diagnostic or operative hysteroscopy with closed cervix before intervention. The INH group (intervention group) received 900 mg of vaginal isoniazid (three 300-mg pills) 6-8 hours before hysteroscopic surgery. The misoprostol group (control group) received 400 micrograms of vaginal misoprostol 6-8 hours before hysteroscopic surgery. Finally, the efficacy of the 2 agents was comparatively analyzed.
Results


Baseline characteristics were comparable between the groups. In 67 cases in the INH group (95%) and 45 in the misoprostol group (50%), hysteroscopic entry was successful without additional mechanical dilation, and this difference was statistically significant (P=0.001). The odds ratio (OR) obtained in this study was 0.57 for both INH and misoprostol groups (OR, 0.57; 95% confidence interval, 0.43-0.75). Further, 19 cases in the INH group vs. 45 cases in the misoprostol group did not respond to the intervention, indicating statistically significance (P=0.001).
Conclusion


Vaginal INH is more effective than misoprostol in cervical ripening before hysteroscopic surgery and can be a good alternative to misoprostol.
Trial Registration


Iranian Registry Clinical Trial (IRCT) Identifier: IRCT2015112821506N4.",2020,Baseline characteristics were comparable between the groups.,"['cervical ripening prior to hysteroscopy', 'patients scheduled for hysteroscopic surgery during April 2016 and June 2017', 'postmenopausal women or those at premenopausal age who had not had a vaginal delivery and candidate for diagnostic or operative hysteroscopy with closed cervix before intervention']","['vaginal isoniazid (isonicotinic acid hydrazide [INH]) and vaginal misoprostol', '400 micrograms of vaginal misoprostol 6-8 hours before hysteroscopic surgery', 'misoprostol', 'Intravaginal isonicotinic acid hydrazide (INH', 'vaginal isoniazid']","['hysteroscopic entry', 'odds ratio (OR']","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0751614', 'cui_str': 'Surgical Procedures, Hysteroscopic'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0567179', 'cui_str': 'Cervix undilated'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C1292429', 'cui_str': '8 hours'}, {'cui': 'C0751614', 'cui_str': 'Surgical Procedures, Hysteroscopic'}, {'cui': 'C0442122', 'cui_str': 'Intravaginal'}]","[{'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",,0.183447,Baseline characteristics were comparable between the groups.,"[{'ForeName': 'Ladan', 'Initials': 'L', 'LastName': 'Haghighi', 'Affiliation': 'Department of Obstetrics and Gynecology, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Najmi', 'Affiliation': 'Department of Obstetrics and Gynecology, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Rokhgireh', 'Affiliation': 'Endometriosis Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Yousef', 'Initials': 'Y', 'LastName': 'Moradi', 'Affiliation': 'Department of Epidemiology, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}]",Obstetrics & gynecology science,['10.5468/ogs.19170']
2872,32550781,Does Preoperative Anxiety Decrease with BATHE Method? A Prospective Randomized Study.,"Introduction


Preoperative anxiety due to anesthesia is a common situation and decreases with preoperative evaluation. The aim of this study is to determine whether utilization of BATHE method further decreases the anxiety scores of patients who are evaluated at an anesthesia clinic for preoperative examination.
Methods


The patients were randomized into ""BATHE"" and ""Control"" groups by using the closed envelope technique. State-Trait Anxiety Inventory (STAI) scores were recorded as entrance STAI for all patients. During preoperative evaluation, BATHE method was applied to the BATHE Group whereas it was not applied to the Control Group. Post-examination, STAI scores were recorded as exit STAI and the patients were later asked questions about their contentment.
Results


Data of 463 patients were included in the analysis. Demographic data was similar in the groups. In both groups the exit STAI scores (BATHE: 34.27±10.30, Control: 34.90±9.54) were lower in comparison to the entrance STAI scores (BATHE: 38.21±9.86, Control: 37.09±9.93). The mean gap between the entrance STAI and exit STAI scores of the BATHE (3.94±6.05) and Control groups (2.19±6.14) were statistically significant (p<0.001).
Conclusion


Utilization of BATHE method decreases the anxiety scores of preoperative patients to a greater extent, as measured by STAI index, in comparison to standard preoperative evaluation.",2020,"In both groups the exit STAI scores (BATHE: 34.27±10.30, Control: 34.90±9.54) were lower in comparison to the entrance STAI scores (BATHE: 38.21±9.86, Control: 37.09±9.93).","['patients who are evaluated at an anesthesia clinic for preoperative examination', '463 patients were included in the analysis']",[],"['State-Trait Anxiety Inventory (STAI) scores', 'mean gap between the entrance STAI and exit STAI scores', 'anxiety scores', 'Demographic data', 'Post-examination, STAI scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",[],"[{'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0337095', 'cui_str': 'Entrance'}, {'cui': 'C0337094', 'cui_str': 'Exit'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",463.0,0.0202658,"In both groups the exit STAI scores (BATHE: 34.27±10.30, Control: 34.90±9.54) were lower in comparison to the entrance STAI scores (BATHE: 38.21±9.86, Control: 37.09±9.93).","[{'ForeName': 'Pınar', 'Initials': 'P', 'LastName': 'Ayvat', 'Affiliation': 'İzmir Democracy University, İzmir, Turkey.'}, {'ForeName': 'Derya', 'Initials': 'D', 'LastName': 'Arslan Yurtlu', 'Affiliation': 'İzmir Katip Çelebi University, Atatürk Education and Research Hospital, Anesthesia Clinic, İzmir, Turkey.'}, {'ForeName': 'Uğur', 'Initials': 'U', 'LastName': 'Özgürbüz', 'Affiliation': 'İzmir Katip Çelebi University, Atatürk Education and Research Hospital, Anesthesia Clinic, İzmir, Turkey.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Güntürkün', 'Affiliation': 'University of Tennessee Health Science Center, Memphis, TN, USA.'}, {'ForeName': 'Kaan', 'Initials': 'K', 'LastName': 'Katircioğlu', 'Affiliation': 'İzmir Katip Çelebi University, Atatürk Education and Research Hospital, Anesthesia Clinic, İzmir, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Kizilkaya', 'Affiliation': 'İzmir Katip Çelebi University, Atatürk Education and Research Hospital, Anesthesia Clinic, İzmir, Turkey.'}]",Noro psikiyatri arsivi,['10.29399/npa.24853']
2873,32550832,An Eye for an Eye: A Randomized Placebo-Controlled Trial of IVIG in Antibody-Mediated Encephalitis.,,2020,,"['An Eye for an Eye', 'Antibody-Mediated Encephalitis']",['Placebo'],[],"[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0014038', 'cui_str': 'Encephalitis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.602623,,"[{'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Gaspard', 'Affiliation': ''}]",Epilepsy currents,['10.1177/1535759720916446']
2874,32550864,"Outcomes of GDPT (gemcitabine, cisplatin, prednisone, thalidomide)  versus  CHOP in newly diagnosed peripheral T-cell lymphoma patients.","Aim


To compare the outcomes of GDPT [gemcitabine (G), cisplatin (D), prednisone (P), thalidomide (T)]  versus  CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) in treating newly diagnosed PTCL (peripheral T-cell lymphoma).
Methods


An open-label prospective clinical trial with 153 newly diagnosed PTCL patients conducted between January 2010 and December 2018 was designed. Patients were randomly assigned to the GDPT (77 cases) and CHOP (76 cases) groups. Patients in each group were further divided into four subgroups: PTCL, not otherwise specified (PTCL-NOS); anaplastic large cell lymphoma (ALCL), angioimmunoblastic T cell lymphoma (AITL), and other types subgroup, in accordance with pathological patterns. Based on expression of  RRM1, TOP2A, TUBB3 , and  ERCC1 , patients were divided into groups with high and low gene expression levels. Clinical characteristics, side effects, efficacy, progression-free survival (PFS), and overall survival (OS) were compared.
Results


There were no significant differences in the basic clinical features or side effects between the GDPT and CHOP groups. The overall response rate (ORR) of the GDPT group was better than that of the CHOP group (66.3%  versus  50.0%,  p  = 0.042), as was the complete remission (CR) rate (42.9%  versus  27.6%,  p  = 0.049). Patients in the GDPT group had a longer PFS and OS than the CHOP group. The 4-year PFS and OS rates in the GDPT group were both superior to those in the CHOP group (63.6%  versus  53.0% for PFS,  p  = 0.035; 66.8%  versus  53.6% for OS,  p  = 0.039). In the GDPT group, the difference in CR between the four subgroups was statistically significant ( p  = 0.046). In the CHOP group, differences in both CR and ORR among the four subgroups were statistically significant ( p  < 0.001 and  p  = 0.005, respectively). There were also statistically significant differences in CR between patients treated with CHOP and GDPT in the PTCL-NOS subgroup, AITL subgroup, and the other types subgroup ( p  = 0.015;  p  = 0.003;  p  = 0.005, respectively). The data also showed a significant difference in OS among the four subgroups within the GDPT group ( p  = 0.001). The OS of AITL was shorter than that of the other three subgroups. Four subgroups of CHOP showed a significant difference in PFS ( p  = 0.019). There was no statistical association between responses and the gene expression levels of  RRM1, ERCC1, TUBB3 , and  TOP2A .
Conclusion


The GDPT group had better response rates and prolonged patient PFS and OS. As a promising new regimen, GDPT is expected to become the first-line therapy for PTCL. New agents should be applied to patients who do not achieve good responses with previous treatment, such as those diagnosed with angioimmunoblastic T cell lymphoma.
Trial registration


This open randomized prospective clinical trial was registered at ClinicalTrials.gov (NCT01664975).",2020,"There was no statistical association between responses and the gene expression levels of  RRM1, ERCC1, TUBB3 , and  TOP2A .
","['treating newly diagnosed PTCL (peripheral T-cell lymphoma', '153 newly diagnosed PTCL patients conducted between January 2010 and December 2018 was designed', 'newly diagnosed peripheral T-cell lymphoma patients']","['GDPT', 'CHOP', 'GDPT [gemcitabine (G), cisplatin (D), prednisone (P), thalidomide (T)]  versus  CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone', 'GDPT (gemcitabine, cisplatin, prednisone, thalidomide)  versus  CHOP']","['Clinical characteristics, side effects, efficacy, progression-free survival (PFS), and overall survival (OS', 'longer PFS and OS', 'OS', 'PFS', 'complete remission (CR) rate', '4-year PFS and OS rates', 'overall response rate (ORR', 'basic clinical features or side effects', 'CR and ORR', 'response rates and prolonged patient PFS and OS', 'gene expression levels of  RRM1, ERCC1, TUBB3 , and  TOP2A ', 'CR']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0055451', 'cui_str': 'chloroterpyridineplatinum(II)'}, {'cui': 'C0079774', 'cui_str': 'Peripheral T-cell lymphoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0055598', 'cui_str': 'CHOP protocol'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1259395', 'cui_str': 'RRM1 protein, human'}, {'cui': 'C0256022', 'cui_str': 'Topoisomerase II alpha'}]",153.0,0.0445903,"There was no statistical association between responses and the gene expression levels of  RRM1, ERCC1, TUBB3 , and  TOP2A .
","[{'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Oncology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Oncology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Oncology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China.'}, {'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China.'}, {'ForeName': 'Xiaorui', 'Initials': 'X', 'LastName': 'Fu', 'Affiliation': 'Department of Oncology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China.'}, {'ForeName': 'Zhenchang', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Oncology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China.'}, {'ForeName': 'Xudong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China.'}, {'ForeName': 'Zhaoming', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Oncology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Oncology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Oncology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Chang', 'Affiliation': 'Department of Oncology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China.'}, {'ForeName': 'Jiaqin', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Department of Oncology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China.'}, {'ForeName': 'Xiaolong', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Oncology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China.'}, {'ForeName': 'Zhiyuan', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Oncology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China.'}, {'ForeName': 'Feifei', 'Initials': 'F', 'LastName': 'Nan', 'Affiliation': 'Department of Oncology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Tian', 'Affiliation': 'Department of Oncology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China.'}, {'ForeName': 'Mingzhi', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, the First Affiliated Hospital of Zhengzhou University, 6th Floor, Building 10, No.1 Construction East Road, Zhengzhou 450001, Henan Province, China.'}]",Therapeutic advances in medical oncology,['10.1177/1758835920923829']
2875,32551097,Analgesic efficacy of nefopam for cancer pain: a randomized controlled study.,"Background:  Nefopam is a non-opioid, non-steroidal, central acting drug used effectively for postoperative pain. The efficacy of nefopam for cancer pain remains unclear. We aimed to evaluate the analgesic efficacy of nefopam for cancer pain in a randomized controlled trial.  Methods : Patients with moderate to severe cancer pain (n=40) were randomly divided into two groups. The nefopam group (n=20) received three 20 mg doses of nefopam every 8 hours. The placebo group (n=20) received normal saline. Intravenous patient-controlled analgesia with morphine was given for breakthrough pain for 48 hours. The primary outcome was significant pain reduction. Secondary outcomes were morphine consumption over 48 hours and incidence of side effects.  Results:  The nefopam group showed pain reduction at 12 hours (65% of patients), 24 hours (80%), 36 hours (85%), and 48 hours (65%). The placebo group showed pain reduction at 12 hours (70%), 24 hours (75%), 36 hours (80%), and 48 hours (60%). However, there were no statistically significant differences between the groups (p>0.05). The median dosage of morphine consumption in 48 hours was lower in the nefopam group (25.5 mg) compared with the placebo group (37 mg), but this was not statistically significant (p=0.499). There were no statistically significant differences in blood pressure and heart rate between the groups. Side effects in both groups were comparable.  Conclusions:  At dosage of 60 mg in 24 hours, nefopam did not provide significant pain reduction in moderate to severe cancer pain patients. However, there was a trend of reduced opioid consumption. Further studies with larger sample sizes, longer duration, or higher doses of nefopam are warranted.  Registration:  Thai Clinical Trail Registry (TCTR) ID TCTR20181016001; registered on 12 October 2018.",2020,"The placebo group showed pain reduction at 12 hours (70%), 24 hours (75%), 36 hours (80%), and 48 hours (60%).","['Methods : Patients with moderate to severe cancer pain (n=40', 'severe cancer pain patients', 'cancer pain']","['normal saline', 'placebo', 'ID', 'nefopam', 'morphine']","['pain reduction', 'median dosage of morphine consumption', 'blood pressure and heart rate', 'Analgesic efficacy', 'reduced opioid consumption', 'analgesic efficacy', 'Side effects', 'morphine consumption over 48 hours and incidence of side effects']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027556', 'cui_str': 'Nefopam'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.211717,"The placebo group showed pain reduction at 12 hours (70%), 24 hours (75%), 36 hours (80%), and 48 hours (60%).","[{'ForeName': 'Koravee', 'Initials': 'K', 'LastName': 'Pasutharnchat', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.'}, {'ForeName': 'Wichita', 'Initials': 'W', 'LastName': 'Wichachai', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.'}, {'ForeName': 'Rungrawan', 'Initials': 'R', 'LastName': 'Buachai', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.'}]",F1000Research,['10.12688/f1000research.23455.1']
2876,32559123,Highlighting Prosocial Affordances of Science in Textbooks to Promote Science Interest.,"The prevalent stereotype that scientific fields do not afford opportunities to fulfill goals of helping others deters student interest and participation in science. We investigated whether introductory college science textbooks that highlight the prosocial utility value of science can be used to change beliefs about the affordances of scientific work. In study 1, undergraduate students who were randomly assigned to read a science textbook chapter with added prosocial utility value expressed greater beliefs that the science topic afforded prosocial goals and increased interest in the scientific topic, compared with two control conditions. Mediation analysis demonstrated that interest was enhanced through increased beliefs that the topic afforded prosocial opportunities. Multiple group comparison tests indicated that underrepresented minority students (i.e., African Americans, Latinos, and Native Americans) might benefit the most from efforts to strengthen prosocial affordance beliefs. In study 2, we conducted a brief landscape analysis of science textbooks and found that texts are missing opportunities to emphasize the prosocial utility value of science. We discuss recommendations for science educators, curriculum designers, and researchers who want to increase and broaden science participation.",2020,Mediation analysis demonstrated that interest was enhanced through increased beliefs that the topic afforded prosocial opportunities.,"['underrepresented minority students (i.e., African Americans, Latinos, and Native Americans', 'undergraduate students']",['science textbook chapter with added prosocial utility value expressed greater beliefs that the science topic afforded prosocial goals'],[],"[{'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0282204', 'cui_str': 'Native Americans'}]","[{'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0039712', 'cui_str': 'Textbooks'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",[],,0.0293534,Mediation analysis demonstrated that interest was enhanced through increased beliefs that the topic afforded prosocial opportunities.,"[{'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Zambrano', 'Affiliation': 'Rossier School of Education, University of Southern California, Los Angeles, CA 90089-4035.'}, {'ForeName': 'Garam Ann', 'Initials': 'GA', 'LastName': 'Lee', 'Affiliation': 'College of Education, Michigan State University, East Lansing, MI 48824.'}, {'ForeName': 'Christina C', 'Initials': 'CC', 'LastName': 'Leal', 'Affiliation': 'Warner School of Education, University of Rochester, Rochester, NY 14627.'}, {'ForeName': 'Dustin B', 'Initials': 'DB', 'LastName': 'Thoman', 'Affiliation': 'Department of Psychology, San Diego State University, San Diego, CA 92182.'}]",CBE life sciences education,['10.1187/cbe.19-09-0176']
2877,32559135,Acute and Chronic Sympathomimetic Effects of E-Cigarette and Tobacco Cigarette Smoking: Role of Nicotine and Non-Nicotine Constituents.,"Electronic cigarettes(ECs) and tobacco cigarettes(TCs) both release nicotine, a sympathomimetic drug. We hypothesized that baseline heart rate variability(HRV) and hemodynamics would be similar in chronic EC and TC-smokers, and that after acute EC use, changes in HRV and hemodynamics would be attributable to nicotine, not non-nicotine constituents in EC aerosol. In 100 smokers, including 58 chronic EC-users and 42 TC-smokers, baseline HRV and hemodynamics (blood pressure[BP] and heart rate[HR]) were compared. To isolate the acute effects of nicotine vs non-nicotine constituents in EC aerosol, we compared changes in HRV, BP and HR in EC-users after using an EC-with-nicotine(ECN), EC-without-nicotine(EC0), nicotine inhaler(NI), or sham-vaping(control). Outcomes were also compared to TC smokers after smoking one TC. Baseline HRV and hemodynamics were not different in chronic EC-users and TC-smokers. In EC-users, BP and HR, but not HRV outcomes, increased only after using the ECN, consistent with a nicotine effect on BP and HR. Similarly, in TC-smokers, BP and HR, but not HRV outcomes increased after smoking one TC. Despite a similar increase in nicotine, the hemodynamic increases were significantly greater after TC-smokers smoked one TC compared to the increases after EC-users used the ECN. In conclusion, chronic EC and TC-smokers exhibit a similar pattern of baseline HRV. Acute increases in BP and HR in EC-users are attributable to nicotine, not non-nicotine constituents, in EC aerosol. The greater acute pressor effects after TC compared to ECN may be attributable to non-nicotine, combusted constituents in TC smoke.",2020,Baseline HRV and hemodynamics were not different in chronic EC-users and TC-smokers.,"['100 smokers, including 58 chronic EC-users and 42 TC-smokers, baseline HRV and hemodynamics (blood']","['Nicotine and Non-Nicotine Constituents', 'ECN', 'nicotine']","['BP and HR', 'Baseline HRV and hemodynamics', 'nicotine, the hemodynamic increases', 'acute pressor effects', 'HRV, BP and HR in EC-users', 'HRV outcomes', 'heart rate[HR']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0005767', 'cui_str': 'Blood'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0729650', 'cui_str': 'Constituents'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0298247', 'cui_str': 'indium-ethylenedicysteine'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]",58.0,0.0184098,Baseline HRV and hemodynamics were not different in chronic EC-users and TC-smokers.,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Arastoo', 'Affiliation': 'Medicine, UCLA, United States.'}, {'ForeName': 'Kacey P', 'Initials': 'KP', 'LastName': 'Haptonstall', 'Affiliation': 'Medicine, UCLA, United States.'}, {'ForeName': 'Yasmine', 'Initials': 'Y', 'LastName': 'Choroomi', 'Affiliation': 'Medicine, UCLA, United States.'}, {'ForeName': 'Roya Susan', 'Initials': 'RS', 'LastName': 'Moheimani', 'Affiliation': 'Medicine, UCLA, United States.'}, {'ForeName': 'Kevin Huan', 'Initials': 'KH', 'LastName': 'Nguyen', 'Affiliation': 'Medicine, UCSF, United States.'}, {'ForeName': 'Elizabeth U', 'Initials': 'EU', 'LastName': 'Tran', 'Affiliation': 'Medicine, UCLA, United States.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Gornbein', 'Affiliation': 'Medicine and Computational Medicine, UCLA, United States.'}, {'ForeName': 'Holly R', 'Initials': 'HR', 'LastName': 'Middlekauff', 'Affiliation': 'Medicine, UCLA, United States.'}]",American journal of physiology. Heart and circulatory physiology,['10.1152/ajpheart.00192.2020']
2878,32559181,Effect of Parenting Training on Neurobehavioral Development of Infants.,"BACKGROUND Early interventions have been believed to have a positive influence on the neurodevelopment of infants. Our Child Health Center has carried out parenting training for parents of infants for several years to promote the neurobehavioral development of infants at an early stage. MATERIAL AND METHODS We enrolled 117 families with term infants age 0-3 months who had completed a parenting training class at the Child Health Center of the Department of Pediatrics, the Third Xiangya Hospital. Parenting training included 4 parts: nursing, intelligence, social contact, and physical ability. A nurse practitioner demonstrated procedures to parents, who then performed them at home for 1 month. The Neonatal Behavioral Neurological Assessment (NBNA) was used to evaluate infants before and 1 month after parenting training. RESULTS In the comparative analysis before and after parenting training, there was a significant increase in the NBNA scores. For the infants whose parents received parenting training, the NBNA scores in total score (33.74±0.19 before parenting training vs. 36.69±0.20 after 1 month), neonatal behavioral capacity (10.19±0.14 before parenting training vs. 11.26±0.10 after 1 month), passive muscle tension (7.28±0.07 before parenting training vs. 7.82±0.04 after 1 month), and initiative muscle tension (4.29±0.08 before the parenting training vs. 5.61±0.13 after 1 month) were significantly higher one month before (P<0.01). CONCLUSIONS Term infant neurobehavior was associated with participation in parenting training, suggesting that these practices of parenting training support better early neurobehavioral development of infants.",2020,"In the comparative analysis before and after parenting training, there was a significant increase in the NBNA scores.","['Infants', '117 families with term infants age 0-3 months who had completed a parenting training class at the Child Health Center of the Department of Pediatrics, the Third Xiangya Hospital']","['Parenting Training', 'parenting training']","['NBNA scores in total score', 'NBNA scores', 'passive muscle tension', 'neonatal behavioral capacity', 'Neonatal Behavioral Neurological Assessment (NBNA', 'initiative muscle tension']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0027853', 'cui_str': 'Neurological examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026841', 'cui_str': 'Muscle Tension'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}]",117.0,0.0160345,"In the comparative analysis before and after parenting training, there was a significant increase in the NBNA scores.","[{'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Department of Pediatrics, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China (mainland).'}, {'ForeName': 'Quyan', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Pediatrics, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China (mainland).'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Pediatrics, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China (mainland).'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'Department of Pediatrics, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China (mainland).'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Huang', 'Affiliation': 'Department of Pediatrics, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China (mainland).'}, {'ForeName': 'Guo', 'Initials': 'G', 'LastName': 'Peng', 'Affiliation': 'Department of Pediatrics, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China (mainland).'}, {'ForeName': 'Jinhui', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Pediatrics, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China (mainland).'}, {'ForeName': 'Mingyi', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Department of Pediatrics, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.924457']
2879,32559272,Exploring the effect of vitamin D3 supplementation on surrogate biomarkers of cholesterol absorption and endogenous synthesis in patients with type 2 diabetes-randomized controlled trial.,"BACKGROUND


Inverse associations have been reported between serum 25-hydroxyvitamin D [25(OH)D] and circulating cholesterol concentrations in observational studies. Postulated mechanisms include reduced bioavailability of intestinal cholesterol and alterations in endogenous cholesterol synthesis.
OBJECTIVE


To explore the effect of daily supplementation with 4000 IU/d vitamin D3 for 24 wk on surrogate biomarkers of cholesterol absorption (campesterol and β-sitosterol) and endogenous synthesis (lathosterol and desmosterol).
METHODS


Ancillary study of The Vitamin D for Established Type 2 Diabetes (DDM2) trial. Patients with established type 2 diabetes (N = 127, 25-75 y, BMI 23-42 kg/m2) were randomly assigned to receive either 4000 IU vitamin D3 or placebo daily for 24 wk. Of participants without changes in cholesterol-lowering medications (n = 114), plasma surrogate cholesterol absorption and endogenous synthesis biomarker concentrations were measured and merged with available measures of serum LDL cholesterol and HDL cholesterol concentrations.
RESULTS


At week 24, vitamin D3 supplementation significantly increased 25(OH)D concentrations (+21.5 ± 13.4 ng/mL) but not insulin secretion rates (primary outcome of the parent study) as reported previously. In this ancillary study there was no significant effect of vitamin D3 supplementation on serum cholesterol profile or surrogate biomarkers of cholesterol absorption and endogenous synthesis. Compared with participants not treated with cholesterol-lowering medications, those who were treated exhibited a greater reduction in plasma campesterol concentrations in the vitamin D3 but not placebo group (P-interaction = 0.011). Analyzing the data on the basis of cholesterol absorption status (hypo- versus hyperabsorbers) or cholesterol synthesis status (hypo- versus hypersynthesizers) did not alter these results.
CONCLUSIONS


Vitamin D3 supplementation for 24 wk had no significant effect on surrogate biomarkers of cholesterol absorption or endogenous synthesis, consistent with the lack of effect on serum cholesterol profile. Vitamin D3 supplementation resulted in greater reduction in campesterol concentrations in participants not using compared with those using cholesterol-lowering medications. Further studies are required.This trial was registered at clinicaltrials.gov as NCT01736865.",2020,Vitamin D3 supplementation resulted in greater reduction in campesterol concentrations in participants not using compared with those using cholesterol-lowering medications.,"['Patients with established type 2 diabetes (N\xa0=\xa0127, 25-75 y, BMI 23-42 kg/m2', 'Established Type 2 Diabetes (DDM2) trial', 'patients with type 2 diabetes']","['Vitamin D', '4000 IU vitamin D3 or placebo', 'daily supplementation with 4000 IU/d vitamin D3', 'vitamin D3 supplementation', 'Vitamin D3 supplementation', 'placebo']","['25(OH)D concentrations', 'serum cholesterol profile or surrogate biomarkers of cholesterol absorption and endogenous synthesis', 'insulin secretion rates', 'serum LDL cholesterol and HDL cholesterol concentrations', 'serum 25-hydroxyvitamin D [25(OH)D] and circulating cholesterol concentrations', 'cholesterol-lowering medications', 'plasma campesterol concentrations', 'plasma surrogate cholesterol absorption and endogenous synthesis biomarker concentrations', 'campesterol concentrations', 'serum cholesterol profile', 'cholesterol absorption (campesterol and β-sitosterol) and endogenous synthesis (lathosterol and desmosterol', 'cholesterol absorption and endogenous synthesis', 'surrogate biomarkers of cholesterol absorption or endogenous synthesis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C3842327', 'cui_str': '4000'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0587184', 'cui_str': 'Serum cholesterol measurement'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0428474', 'cui_str': 'Serum LDL cholesterol measurement'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0054560', 'cui_str': 'campesterol'}, {'cui': 'C0037215', 'cui_str': 'Sitosterols'}, {'cui': 'C0064673', 'cui_str': 'Lathosterol'}, {'cui': 'C0011704', 'cui_str': '24-Dehydrocholesterol'}]",,0.270391,Vitamin D3 supplementation resulted in greater reduction in campesterol concentrations in participants not using compared with those using cholesterol-lowering medications.,"[{'ForeName': 'Huicui', 'Initials': 'H', 'LastName': 'Meng', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.'}, {'ForeName': 'Nirupa R', 'Initials': 'NR', 'LastName': 'Matthan', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Angellotti', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Anastassios G', 'Initials': 'AG', 'LastName': 'Pittas', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Alice H', 'Initials': 'AH', 'LastName': 'Lichtenstein', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa149']
2880,32559463,Dynamic trial fitting by an expanding trial cup does not jeopardize primary acetabular component stability.,"BACKGROUND


Trial fitting of the acetabular component in uncemented total hip replacement is traditionally done by trial cups. Since trial cups do not resemble the real press-fit obtained by the definitive cup, a dynamic trial inserter, called the X-pander ®, was developed to mimic the real amount of press-fit. However, the concern is raised of losing the initial press-fit by using the X-pander® due to pre-expansion of the acetabulum. The purpose of this study was to assess if there is a difference in primary stability between both methods.
METHODS


A biomechanical randomized study was performed with bovine calf acetabula, with randomization between either using the X-pander® or the traditional trial cups to assess primary stability. The primary outcome was the force needed to achieve lever out of the implanted cup (Anexys, Mathys or Trident, Stryker), measured in Newton meter (Nm) with a biomechanical testing set up.
FINDINGS


In total, 54 cups (19 Anexys, 35 Trident) were inserted and tested after randomized trial fitting. Overall mean lever out was 45.1 Nm (SD 14.6) for the X-pander® group and 45.0 Nm (SD 14.5) for the trial cups group. After adjustment for potential confounders (cup size and type) mixed model analysis did not reveal a significant difference in lever out force between both testing devices (mean 1.0 Nm, 95%CI (-5.9; 8.0), p = .77).
INTERPRATION


Initial press-fit of the implanted cup is not lost by pre-expansion as done with dynamic trial fitting with the X-pander®.",2020,"After adjustment for potential confounders (cup size and type) mixed model analysis did not reveal a significant difference in lever out force between both testing devices (mean 1.0 Nm, 95%CI (-5.9; 8.0), p = .77).
",[],"['INTERPRATION', 'bovine calf acetabula']","['force needed to achieve lever out of the implanted cup (Anexys, Mathys or Trident, Stryker), measured in Newton meter (Nm) with a biomechanical testing set up']",[],"[{'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0000962', 'cui_str': 'Bone structure of acetabulum'}]","[{'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C1430904', 'cui_str': 'FOXM1 protein, human'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0542569', 'cui_str': 'newton'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]",54.0,0.260371,"After adjustment for potential confounders (cup size and type) mixed model analysis did not reveal a significant difference in lever out force between both testing devices (mean 1.0 Nm, 95%CI (-5.9; 8.0), p = .77).
","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Hoornenborg', 'Affiliation': 'Xpert Orthopedie Amsterdam/SCORE (Specialized Center of Orthopedic Research and Education), Laarderhoogtweg 12, 1101EA Amsterdam, the Netherlands. Electronic address: d.hoornenborg@xpertorthopedie.nl.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van Loon', 'Affiliation': 'Xpert Orthopedie Amsterdam/SCORE (Specialized Center of Orthopedic Research and Education), Laarderhoogtweg 12, 1101EA Amsterdam, the Netherlands; Academic Medical Center Amsterdam, Department of Orthopedic Surgery, Meibergdreef 15, 1105 AZ Amsterdam, the Netherlands. Electronic address: justin.vanloon@amc.uva.nl.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'de Waard', 'Affiliation': 'Xpert Orthopedie Amsterdam/SCORE (Specialized Center of Orthopedic Research and Education), Laarderhoogtweg 12, 1101EA Amsterdam, the Netherlands.'}, {'ForeName': 'I N', 'Initials': 'IN', 'LastName': 'Sierevelt', 'Affiliation': 'Xpert Orthopedie Amsterdam/SCORE (Specialized Center of Orthopedic Research and Education), Laarderhoogtweg 12, 1101EA Amsterdam, the Netherlands. Electronic address: i.n.sierevelt@score-amsterdam.nl.'}, {'ForeName': 'K T M', 'Initials': 'KTM', 'LastName': 'Opdam', 'Affiliation': 'Academic Medical Center Amsterdam, Department of Orthopedic Surgery, Meibergdreef 15, 1105 AZ Amsterdam, the Netherlands. Electronic address: k.t.opdam@amc.uva.nl.'}, {'ForeName': 'G M M J', 'Initials': 'GMMJ', 'LastName': 'Kerkhoffs', 'Affiliation': 'Academic Medical Center Amsterdam, Department of Orthopedic Surgery, Meibergdreef 15, 1105 AZ Amsterdam, the Netherlands. Electronic address: g.m.kerkhoffs@amc.uva.nl.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Haverkamp', 'Affiliation': 'Xpert Orthopedie Amsterdam/SCORE (Specialized Center of Orthopedic Research and Education), Laarderhoogtweg 12, 1101EA Amsterdam, the Netherlands. Electronic address: d.haverkamp@xpertorthopedie.nl.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105077']
2881,32559474,"Effects of the SGLT2 inhibitor dapagliflozin on proteinuria in non-diabetic patients with chronic kidney disease (DIAMOND): a randomised, double-blind, crossover trial.","BACKGROUND


SGLT2 inhibition decreases albuminuria and reduces the risk of kidney disease progression in patients with type 2 diabetes. These benefits are unlikely to be mediated by improvements in glycaemic control alone. Therefore, we aimed to examine the kidney effects of the SGLT2 inhibitor dapagliflozin in patients with proteinuric kidney disease without diabetes.
METHODS


DIAMOND was a randomised, double-blind, placebo-controlled crossover trial done at six hospitals in Canada, Malaysia, and the Netherlands. Eligible participants were adult patients (aged 18-75 years) with chronic kidney disease, without a diagnosis of diabetes, with a 24-h urinary protein excretion greater than 500 mg and less than or equal to 3500 mg and an estimated glomerular filtration rate (eGFR) of at least 25 mL/min per 1·73 m 2 , and who were on stable renin-angiotensin system blockade. Participants were randomly assigned (1:1) to receive placebo and then dapagliflozin 10 mg per day or vice versa. Each treatment period lasted 6 weeks with a 6-week washout period in between. Participants, investigators, and study personnel were masked to assignment throughout the trial and analysis. The primary outcome was percentage change from baseline in 24-h proteinuria during dapagliflozin treatment relative to placebo. Secondary outcomes were changes in measured GFR (mGFR; via iohexol clearance), bodyweight, blood pressure, and concentrations of neurohormonal biomarkers. Analyses were done in accordance with the intention-to-treat principle. This study is registered with ClinicalTrials.gov, NCT03190694.
FINDINGS


Between Nov 22, 2017, and April 5, 2019, 58 patients were screened, of whom 53 (mean age 51 years [SD 13]; 32% women) were randomly assigned (27 received dapagliflozin then placebo and 26 received placebo then dapagliflozin). One patient discontinued during the first treatment period. All patients were included in the analysis. Mean baseline mGFR was 58·3 mL/min per 1·73 m 2  (SD 23), median proteinuria was 1110 mg per 24 h (IQR 730-1560), and mean HbA 1c  was 5·6% (SD 0·4). The difference in mean proteinuria change from baseline between dapagliflozin and placebo was 0·9% (95% CI -16·6 to 22·1; p=0·93). Compared with placebo, mGFR was changed with dapagliflozin treatment by -6·6 mL/min per 1·73 m 2  (-9·0 to -4·2; p<0·0001) at week 6. This reduction was fully reversible within 6 weeks after dapagliflozin discontinuation. Compared with placebo, bodyweight was reduced by 1·5 kg (0·03-3·0; p=0·046) with dapagliflozin; changes in systolic and diastolic blood pressure and concentrations of neurohormonal biomarkers did not differ significantly between dapagliflozin and placebo treatment. The numbers of patients who had one or more adverse events during dapagliflozin treatment (17 [32%] of 53) and during placebo treatment (13 [25%] of 52) were similar. No hypoglycaemic events were reported and no deaths occurred.
INTERPRETATION


6-week treatment with dapagliflozin did not affect proteinuria in patients with chronic kidney disease without diabetes, but did induce an acute and reversible decline in mGFR and a reduction in bodyweight. Long-term clinical trials are underway to determine whether SGLT2 inhibitors can safely reduce the rate of major clinical kidney outcomes in patients with chronic kidney disease with and without diabetes.
FUNDING


AstraZeneca.",2020,"Compared with placebo, mGFR was changed with dapagliflozin treatment by -6·6 mL/min per 1·73 m 2  (-9·0 to -4·2; p<0·0001) at week 6.","['Eligible participants were adult patients (aged 18-75 years) with chronic kidney disease, without a diagnosis of diabetes, with a 24-h urinary protein excretion greater than 500 mg and less than or equal to 3500 mg and an estimated glomerular filtration rate (eGFR) of at least 25 mL/min per 1·73 m 2 , and who were on stable renin-angiotensin system blockade', '58 patients were screened, of whom 53 (mean age 51 years [SD 13]; 32% women', 'patients with chronic kidney disease with and without diabetes', 'Between Nov 22, 2017, and April 5, 2019', 'patients with proteinuric kidney disease without diabetes', 'patients with type 2 diabetes', 'non-diabetic patients with chronic kidney disease (DIAMOND', 'patients with chronic kidney disease without diabetes', 'six hospitals in Canada, Malaysia, and the Netherlands']","['dapagliflozin then placebo', 'dapagliflozin', 'SGLT2 inhibitors', 'placebo and then dapagliflozin 10 mg per day or vice versa', 'SGLT2 inhibitor dapagliflozin', 'placebo then dapagliflozin', 'dapagliflozin and placebo', 'placebo']","['systolic and diastolic blood pressure and concentrations of neurohormonal biomarkers', 'median proteinuria', 'percentage change from baseline in 24-h proteinuria', 'mean proteinuria change', 'adverse events', 'hypoglycaemic events', 'changes in measured GFR (mGFR; via iohexol clearance), bodyweight, blood pressure, and concentrations of neurohormonal biomarkers', 'Mean baseline mGFR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439090', 'cui_str': '<='}, {'cui': 'C4517736', 'cui_str': '3500'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0057717', 'cui_str': 'Diamond'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0439505', 'cui_str': '/day'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0022005', 'cui_str': 'Iohexol'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",58.0,0.624837,"Compared with placebo, mGFR was changed with dapagliflozin treatment by -6·6 mL/min per 1·73 m 2  (-9·0 to -4·2; p<0·0001) at week 6.","[{'ForeName': 'David Z I', 'Initials': 'DZI', 'LastName': 'Cherney', 'Affiliation': 'Division of Nephrology, Department of Medicine, University Health Network and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Claire C J', 'Initials': 'CCJ', 'LastName': 'Dekkers', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen, Netherlands.'}, {'ForeName': 'Sean J', 'Initials': 'SJ', 'LastName': 'Barbour', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Cattran', 'Affiliation': 'Division of Nephrology, Department of Medicine, University Health Network and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Abdul Halim', 'Initials': 'AH', 'LastName': 'Abdul Gafor', 'Affiliation': 'Department of Medicine, Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Greasley', 'Affiliation': 'Early Clinical Development, Research and Early Development, Cardiovascular, Renal and Metabolism (CVRM), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Gozewijn D', 'Initials': 'GD', 'LastName': 'Laverman', 'Affiliation': 'Department of Internal Medicine, ZGT Hospital, Almelo and Hengelo, Netherlands.'}, {'ForeName': 'Soo Kun', 'Initials': 'SK', 'LastName': 'Lim', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Gian Luca', 'Initials': 'GL', 'LastName': 'Di Tanna', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Heather N', 'Initials': 'HN', 'LastName': 'Reich', 'Affiliation': 'Division of Nephrology, Department of Medicine, University Health Network and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Marc G', 'Initials': 'MG', 'LastName': 'Vervloet', 'Affiliation': 'Department of Nephrology and Amsterdam Cardiovascular Sciences, Amsterdam University Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'Muh Geot', 'Initials': 'MG', 'LastName': 'Wong', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia; Royal North Shore Hospital, St Leonards, NSW, Australia.'}, {'ForeName': 'Ron T', 'Initials': 'RT', 'LastName': 'Gansevoort', 'Affiliation': 'Department of Nephrology, University of Groningen, University Medical Centre Groningen, Groningen, Netherlands.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen, Netherlands. Electronic address: h.j.lambers.heerspink@umcg.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30162-5']
2882,32559515,Fampridine-induced changes in walking kinetics are associated with clinical improvements in patients with multiple sclerosis.,"Gait dysfunction is common in patients with multiple sclerosis (PwMS). Treatment with prolonged-release fampridine (PR-fampridine) improves walking ability in some PwMS. Associated fampridine-induced changes in the walking pattern are still poorly understood but may provide a better understanding of the mechanisms underlying the beneficial drug effects. 61 PwMS were treated with PR-fampridine in a randomized, monocentric, double-blind and placebo-controlled clinical trial with crossover design (FAMPKIN). Drug-induced improvements in walking speed (Timed-25-Foot Walk; T25FW) and endurance (6-Minute Walk Test; 6MWT) were quantified. In this sub-study of the FAMPKIN trial, fampridine-induced changes in kinetic gait patterns were analyzed by pressure-based foot print analysis during treadmill walking. Vertical ground reaction forces were analyzed during different gait phases. Kinetic data of 44 PwMS was eligible for analysis. During double-blind treatment with PR-fampridine, patients performed significantly better in the T25FW and 6MWT than during placebo treatment (p < 0.0001 for both). At the group level (n = 44), there were no significant changes of gait kinetics under PR-fampridine vs. placebo. However, we found relevant changes of walking kinetics regarding forces during loading, single limb and pre-swing phase in a patient sub-group (n = 8). Interestingly, this sub-group demonstrated superior responsiveness to PR-fampridine in the clinical walking tests compared to those patients without any fampridine-induced changes in kinetics (n = 36). Our results demonstrate fampridine-induced changes in gait kinetics in a sub-group of PwMS. These gait pattern changes were accompanied by improved clinical walking performance under PR-fampridine. These results shed some light on the biomechanical changes in walking patterns underlying enhanced fampridine-induced gait performance.",2020,"At the group level (n = 44), there were no significant changes of gait kinetics under PR-fampridine vs. placebo.","['patients with multiple sclerosis', 'patients with multiple sclerosis (PwMS']","['PR-fampridine', 'prolonged-release fampridine (PR-fampridine', 'placebo']","['clinical walking performance', 'Vertical ground reaction forces', 'walking kinetics', 'gait kinetics', 'Gait dysfunction', 'walking speed (Timed-25-Foot Walk; T25FW) and endurance (6-Minute Walk Test; 6MWT', 'kinetic gait patterns', 'T25FW and 6MWT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0000477', 'cui_str': 'dalfampridine'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",61.0,0.124543,"At the group level (n = 44), there were no significant changes of gait kinetics under PR-fampridine vs. placebo.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Weller', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Frauenklinikstrasse 26, 8091 Zurich, Switzerland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Lörincz', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Frauenklinikstrasse 26, 8091 Zurich, Switzerland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Sutter', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Frauenklinikstrasse 26, 8091 Zurich, Switzerland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reuter', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Frauenklinikstrasse 26, 8091 Zurich, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Linnebank', 'Affiliation': 'Department of Neurology, University Witten/Herdecke and Evangelische Kliniken Gelsenkirchen, Munckelstraße 32, 45879 Gelsenkirchen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Weller', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Frauenklinikstrasse 26, 8091 Zurich, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Zörner', 'Affiliation': 'Spinal Cord Injury Center, Balgrist University Hospital, Forchstrasse 340, 8008 Zurich, Switzerland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Filli', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Frauenklinikstrasse 26, 8091 Zurich, Switzerland; Spinal Cord Injury Center, Balgrist University Hospital, Forchstrasse 340, 8008 Zurich, Switzerland; Swiss Center for clinical Movement Analysis (SCMA), Balgrist Campus AG, Lengghalde 5, 8008 Zurich, Switzerland. Electronic address: linard.filli@balgrist.ch.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116978']
2883,32556865,Machine learning-based development and validation of a scoring system for progression-free survival in liver cancer.,"OBJECT


Disease progression is an important factor affecting the long-term survival in hepatocellular carcinoma (HCC). The progression-free survival (PFS) has been used as a surrogate endpoint for overall survival (OS) in many solid tumors. However, there were few models to predict the PFS in HCC patients. This study aimed to explore the prognostic factors that affect the PFS in HCC and establish an individualized prediction model.
METHODS


We included 2890 patients with hepatitis B-related HCC hospitalized at Beijing Ditan Hospital, Capital Medical University and randomly divided into training and validation cohort. Cox multivariate regression was used to analyze independent risk factors affecting the 1-year PFS of HCC, and an artificial neural networks (ANNs) model was constructed. C-index, calibration curve, and decision curve analysis were used to evaluate the performance of the model.
RESULTS


The median survival time was 26.2 m (95% CI: 24.08-28.32) and the 1-year PFS rate was 52.3% in whole study population. Cox multivariate regression showed smoking history, tumor number ≥ 2, tumor size ≥ 5 cm, portal vein tumor thrombus, WBC, NLR, γ-GGT, ALP, and AFP ≥ 400 ng/mL were risk factors for 1-year progression-free survival, while albumin and CD4 T cell counts were protective factors in HCC patients. A prediction model for 1-year PFS was constructed (https://lixuan.me/annmodel/myg-v3/). The ANNs model's ability to predict 1-year PFS had an area under the receiver operating characteristic curve (AUROC) of 0.866 (95% CI 0.848-0.884) in HCC patients, which was higher than predicted by TNM, BCLC, Okuda, CLIP, CUPI, JIS, and ALBI scores (p < 0.0001). In addition, the ANNs model could also estimate the probability of 1-year OS and presented a higher AUROC value, 0.877 (95% CI 0.858-0.895), than those other models. All patients were divided into high-, medium-, and low-risk groups, according to the ANNs model scores. Compared with the hazard ratios (HRs) of PFS and OS in low-risk group, those in the high-risk group were 26.42 (95% CI 18.74-37.25; p < 0.0001) and 11.26 (95% CI 9.11-13.93; p < 0.0001), respectively.
CONCLUSION


The ANNs model has good individualized prediction performance and may be helpful to evaluate the probability of progression-free survival in HCC during clinical practice.",2020,The ANNs model has good individualized prediction performance and may be helpful to evaluate the probability of progression-free survival in HCC during clinical practice.,"['hepatocellular carcinoma (HCC', '2890 patients with hepatitis B-related HCC hospitalized at Beijing Ditan Hospital, Capital Medical University and randomly divided into training and validation cohort', 'liver cancer']",[],"['smoking history, tumor number\u2009≥\u20092, tumor size\u2009≥\u20095\xa0cm, portal vein tumor thrombus, WBC, NLR, γ-GGT, ALP, and AFP', 'TNM, BCLC, Okuda, CLIP, CUPI, JIS, and ALBI scores', 'median survival time', '1-year PFS rate', 'hazard ratios (HRs) of PFS and OS', 'progression-free survival (PFS', 'probability of 1-year OS', 'risk factors for 1-year progression-free survival, while albumin and CD4 T cell counts']","[{'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0345904', 'cui_str': 'Malignant neoplasm of liver'}]",[],"[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0032718', 'cui_str': 'Portal vein structure'}, {'cui': 'C3163918', 'cui_str': 'Tumor thrombus'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0201539', 'cui_str': 'Alpha-1-Fetoprotein measurement'}, {'cui': 'C0039694', 'cui_str': 'Tetranitromethane'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",2890.0,0.0614393,The ANNs model has good individualized prediction performance and may be helpful to evaluate the probability of progression-free survival in HCC during clinical practice.,"[{'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Center of Integrative Medicine,\xa0Beijing Ditan Hospital, Capital Medical University, No. 8 Jing Shun East Street, Beijing, 100015, China.'}, {'ForeName': 'Yixin', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': 'Center of Integrative Medicine,\xa0Beijing Ditan Hospital, Capital Medical University, No. 8 Jing Shun East Street, Beijing, 100015, China.'}, {'ForeName': 'Xinhui', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Center of Integrative Medicine,\xa0Beijing Ditan Hospital, Capital Medical University, No. 8 Jing Shun East Street, Beijing, 100015, China.'}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'Center of Integrative Medicine,\xa0Beijing Ditan Hospital, Capital Medical University, No. 8 Jing Shun East Street, Beijing, 100015, China.'}, {'ForeName': 'Xianbo', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Center of Integrative Medicine,\xa0Beijing Ditan Hospital, Capital Medical University, No. 8 Jing Shun East Street, Beijing, 100015, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Hepatobiliary Surgery,\xa0Beijing Ditan Hospital, Capital Medical University, No. 8 Jing Shun East Street, Beijing, 100015, China. movdush@139.com.'}, {'ForeName': 'Zhiyun', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Center of Integrative Medicine,\xa0Beijing Ditan Hospital, Capital Medical University, No. 8 Jing Shun East Street, Beijing, 100015, China. yangzhiyun2016@163.com.'}]",Hepatology international,['10.1007/s12072-020-10046-w']
2884,32556870,"Total Laparoscopic Uncut Roux-en-Y for Radical Distal Gastrectomy: An Interim Analysis of a Randomized, Controlled, Clinical Trial.","BACKGROUND


The traditional Billroth II and Roux-en-Y anastomosis after laparoscopic distal gastrectomy for gastric cancer are associated with bile reflux gastritis and roux stasis syndrome, respectively. The uncut Roux-en-Y gastrojejunostomy can decrease the incidence of these complications by blocking the entry of bile and pancreatic juice into the residual stomach and retaining the impulses originating from the duodenum. The purpose of the present study was to compare the short-term outcomes of uncut Roux-en-Y (URY) and Billroth II combined Braun (BB) anastomosis.
METHODS


In this prospective, multi-center, two-arm randomized controlled trial, 124 patients with advanced distal gastric cancer were randomized into two groups: URY (n = 62) and BB (n = 62) groups.
RESULTS


The mean gastric juice pH was significantly lower in the URY group compared with the BB group (3.94 ± 0.71 vs. 5.83 ± 0.91, P < 0.0001). The bile reflux gastritis at 3 months (P < 0.0001) and 6 months (P = 0.002) was significantly more frequent in the BB group. No recanalization occurred in the URY group, and no significant difference was found between the two groups in terms of mean operative time (P = 0.69), mean time to perform anastomosis (P = 0.86), mean estimated blood loss (P = 0.77), mean number of harvested lymph nodes (P = 0.90), time to first passage of flatus or defecation (P = 0.87), postoperative hospital stay (P = 0.83), and the incidence of postoperative complications (P = 0.70).
CONCLUSIONS


URY anastomosis is associated with a significantly lower incidence of bile reflux gastritis and roux stasis syndrome compared with BB anastomosis.",2020,The bile reflux gastritis at 3 months (P < 0.0001) and 6 months (P = 0.002) was significantly more frequent in the BB group.,['124 patients with advanced distal gastric cancer'],"['traditional Billroth II and Roux-en-Y anastomosis after laparoscopic distal gastrectomy', 'Total Laparoscopic Uncut Roux-en-Y for Radical Distal Gastrectomy', 'uncut Roux-en-Y (URY) and Billroth II combined Braun (BB) anastomosis']","['mean time to perform anastomosis', 'incidence of postoperative complications', 'time to first passage of flatus or defecation', 'mean gastric juice pH', 'No recanalization', 'bile reflux gastritis and roux stasis syndrome', 'bile reflux gastritis', 'mean operative time', 'mean number of harvested lymph nodes', 'postoperative hospital stay', 'mean estimated blood loss']","[{'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0192444', 'cui_str': 'Resection of stomach with gastrojejunal anastomosis'}, {'cui': 'C0002804', 'cui_str': 'Roux-en-Y - action'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0192440', 'cui_str': 'Distal subtotal gastrectomy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0017133', 'cui_str': 'Gastric juice'}, {'cui': 'C0034771', 'cui_str': 'Recanalization'}, {'cui': 'C0149631', 'cui_str': 'Bile-induced gastritis'}, {'cui': 'C0005750', 'cui_str': 'Blind loop syndrome'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",124.0,0.0398602,The bile reflux gastritis at 3 months (P < 0.0001) and 6 months (P = 0.002) was significantly more frequent in the BB group.,"[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Digestive Surgery, State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Department of Digestive Surgery, State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Junqiang', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': ""Department of Radiology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Kelu', 'Initials': 'K', 'LastName': 'Yang', 'Affiliation': 'Evidence-Based Nursing Center, School of Nursing, Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Sheqing', 'Initials': 'S', 'LastName': 'Ji', 'Affiliation': 'Henan Cancer Hospital and Zhengzhou University Cancer Hospital, Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Department of Minimally Invasive Surgery, the Second Hospital of Lanzhou University, Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Minimally Invasive Surgery, the Second Hospital of Lanzhou University, Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Ma', 'Affiliation': 'Henan Cancer Hospital and Zhengzhou University Cancer Hospital, Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Qiuya', 'Initials': 'Q', 'LastName': 'Wei', 'Affiliation': 'Department of Minimally Invasive Surgery, the Second Hospital of Lanzhou University, Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Ji', 'Affiliation': ""Department of Digestive Surgery, State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China. jigangfmmu@163.com.""}]",Annals of surgical oncology,['10.1245/s10434-020-08710-4']
2885,32556876,Steroid Knee Injections for Arthritis Are No Better than Placebo in a Randomized Controlled Trial.,,2020,,[],"['Placebo', 'Steroid Knee Injections']",[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0187946', 'cui_str': 'Injection of knee joint'}]",[],,0.117495,,"[{'ForeName': 'Stephanie G', 'Initials': 'SG', 'LastName': 'Wheeler', 'Affiliation': 'Department of Medicine , University of Washington, Seattle, WA, USA. stephanie.wheeler@va.gov.'}]",Journal of general internal medicine,['10.1007/s11606-020-05647-y']
2886,32550713,Ischemic preconditioning improves performance and accelerates the heart rate recovery.,"BACKGROUND


Previous studies have assessed the effects of ischemic preconditioning (IPC) on exercise performance and physiological variables, such as lactate and muscle deoxygenation. In this study, we verified the IPC effects on heart rate and performance during and immediately after a maximal incremental cycling test.
METHODS


Eighteen recreationally trained cyclists (28 ± 4 years) were allocated to one of three groups: IPC, SHAM and Control. After the first visit to familiarization, cyclists attended the laboratory on two separate occasions to perform an incremental cycling test: in the 1st visit they performed the reference test (baseline), and in 2nd the test ischemic preconditioning (2 cycles of 5-min occlusion [at 50 mm Hg above systolic arterial pressure]/ 5-min reperfusion), SHAM (identical to ischemic preconditioning, but at 20 mm Hg) or control (no occlusion) interventions (post intervention). During the incremental cycling test, heart rate, power output and perceived exertion were measured and the heart rate was monitored throughout the recovery.
RESULTS


Only ischemic preconditioning group improved performance time by 4.9 ± 4.0% and decreased heart rate at submaximal point during incremental cycling test, of 170 ± 8 to 166 ± 8 bpm (p<0.05). Also, IPC promoted faster heart rate recovery, mainly on first minute (from 151 ± 9 to 145 ± 8 bpm; p<0.05), compared to baseline. No differences for other parameters were found.
CONCLUSIONS


Two cycles of five minutes of ischemia were relevant to produce positive effects on performance and alter the heart rate during and soon after incremental cycling test.",2020,"Also, IPC promoted faster heart rate recovery, mainly on first minute (from 151 ± 9 to 145 ± 8 bpm; p<0.05), compared to baseline.",['Eighteen recreationally trained cyclists (28 ± 4 years'],"['ischemic preconditioning (IPC', 'IPC, SHAM and Control', 'Ischemic preconditioning', 'SHAM (identical to ischemic preconditioning, but at 20 mm Hg) or control (no occlusion) interventions', 'IPC']","['heart rate, power output and perceived exertion', 'performance time', 'heart rate', 'heart rate recovery', 'heart rate and performance']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",18.0,0.164322,"Also, IPC promoted faster heart rate recovery, mainly on first minute (from 151 ± 9 to 145 ± 8 bpm; p<0.05), compared to baseline.","[{'ForeName': 'Rhaí A', 'Initials': 'RA', 'LastName': 'Arriel', 'Affiliation': 'Department of Physiology, Universidade Federal de Juiz de Fora, Juiz de Fora, Minas Gerais, Brazil.'}, {'ForeName': 'Anderson', 'Initials': 'A', 'LastName': 'Meireles', 'Affiliation': 'Department of Physiology, Universidade Federal de Juiz de Fora, Juiz de Fora, Minas Gerais, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Hohl', 'Affiliation': 'Department of Physiology, Universidade Federal de Juiz de Fora, Juiz de Fora, Minas Gerais, Brazil.'}, {'ForeName': 'Moacir', 'Initials': 'M', 'LastName': 'Marocolo', 'Affiliation': 'Department of Physiology, Universidade Federal de Juiz de Fora, Juiz de Fora, Minas Gerais, Brazil - isamjf@gmail.com.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10822-3']
2887,32550738,Comparison of pain and proper sample status according to usage of tenaculum and analgesia: a randomized clinical trial.,"Objective


Colposcopic biopsy is a discomfortable procedure. Additionally, it creates negative influence on sexuality. This study aimed to investigate the relationships among tenaculum, pain perception, and biopsy size during colposcopy.
Methods


In total, 228 patients who underwent colposcopy-directed biopsy were included, and randomized into 4 groups based on whether analgesic and tenaculum were used and replaced (tenaculum with n=58/without analgesic n=56, no tenaculum replacement with n=57/without analgesic n=57). Lidocaine hydrochloride (40 mg) plus adrenaline (0.025 mg) was administered in the analgesic groups. The pain was assessed using a linear visual analog scale. The biopsy specimen size was measured in millimeters.
Results


The mean age of the patients was 42.85±8.88 years. The most frequent colposcopy indications were atypical squamous cells of undetermined significance and human papilloma virus-positive results on cervical cytology (30.2%; n=69). Low- and high-grade intraepithelial lesions were noted in 14.91% (n=34) and 10.96% (n=25) women through colposcopy-directed biopsy results, respectively. Tenaculum replacement increased pain perception in the without analgesic group; however, no statistically significant differences were noted between of the groups with and without tenaculum replacement with analgesic. The size and number of biopsy specimens were not associated with tenaculum replacement and analgesic use.
Conclusion


Administration of analgesics decreased discomfort and pain in patients. Tenaculum replacement aided colposcopists in manipulating the cervix. Additionally, administration of analgesics relieved pain in the tenaculum replacement group.
Trial Registration


ClinicalTrials.gov Identifier: NCT03279666.",2020,"Tenaculum replacement increased pain perception in the without analgesic group; however, no statistically significant differences were noted between of the groups with and without tenaculum replacement with analgesic.","['228 patients who underwent colposcopy-directed biopsy', 'patients']","['adrenaline', 'tenaculum and analgesia', 'Lidocaine hydrochloride', 'analgesic and tenaculum were used and replaced (tenaculum with n=58/without analgesic n=56, no tenaculum replacement with n=57/without analgesic n=57']","['Low- and high-grade intraepithelial lesions', 'biopsy specimen size', 'sexuality', 'cervical cytology', 'discomfort and pain', 'pain', 'pain perception']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009417', 'cui_str': 'Colposcopy'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0180964', 'cui_str': 'Tenaculum'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0546869', 'cui_str': 'Lidocaine hydrochloride'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0856201', 'cui_str': 'Cervical cytology'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",228.0,0.0996657,"Tenaculum replacement increased pain perception in the without analgesic group; however, no statistically significant differences were noted between of the groups with and without tenaculum replacement with analgesic.","[{'ForeName': 'Cihan', 'Initials': 'C', 'LastName': 'Comba', 'Affiliation': 'Division of Gynecologic Oncology, Department of Gynecology and Obstetrics, University of Health Sciences, Sultangazi Haseki Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Gökhan', 'Initials': 'G', 'LastName': 'Demirayak', 'Affiliation': 'Division of Gynecologic Oncology, Department of Gynecology and Obstetrics, University of Health Sciences, Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Sakir Volkan', 'Initials': 'SV', 'LastName': 'Erdogan', 'Affiliation': 'Department of Gynecology and Obstetrics, University of Health Sciences, Bagcilar Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Karaca', 'Affiliation': 'Department of Gynecology and Obstetrics, University of Health Sciences, Tepecik Training and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Demir', 'Affiliation': 'Department of Gynecology and Obstetrics, Karadeniz Technical University, Trabzon, Turkey.'}, {'ForeName': 'Oguz', 'Initials': 'O', 'LastName': 'Guler', 'Affiliation': 'Department of Gynecology and Obstetrics, Kucukkoy Bilge Hospital, Istanbul, Turkey.'}, {'ForeName': 'Isa Aykut', 'Initials': 'IA', 'LastName': 'Ozdemir', 'Affiliation': 'Division of Gynecologic Oncology, Department of Gynecology and Obstetrics, Medipol University Mega Hospital, Istanbul, Turkey.'}]",Obstetrics & gynecology science,['10.5468/ogs.19185']
2888,32551281,Role of Image Guided Navigation in Endoscopic Surgery of Paranasal Sinuses: A Comparative Study.,"The aim of the current study is to share our experience with surgical outcomes of Functional Endoscopic Sinus Surgery using an image-guidance system. The study was a randomised control trial with the comparison between two groups. Image guidance system (Electromagnetic) was used for endoscopic surgery on patients with disease of the paranasal sinuses (n = 30). Results were compared with those in control patients who underwent similar surgery without image guidance during the same period (n = 30). The operating room time (image-guidance group, 165.68 ± 6.55 min [mean ± SE]; control group, 163.33 ± 5.43 min), Intraoperative anatomical localization was accurate to within 2 mm. Intraoperative blood loss (image-guidance group, 566.67 ± 62.23 ml [mean ± SE]; control group, 636.33 ± 72.59 mL) and complication rates (image-guidance group, 3.3%; control group, 3.3%) did not differ significantly between groups. We find image guidance system a useful tool with accuracy of 2 mm. Actual intraoperative time, blood loss and complications do not differ significantly with or without the use of IGS.",2020,"Intraoperative blood loss (image-guidance group, 566.67 ± 62.23 ","['patients with disease of the paranasal sinuses (n\u2009=\u200930', 'Endoscopic Surgery of Paranasal Sinuses']","['Functional Endoscopic Sinus Surgery', 'SE', 'Image Guided Navigation', 'Image guidance system (Electromagnetic']","['Intraoperative anatomical localization', 'complication rates', 'ml [mean\u2009±\u2009SE', 'Actual intraoperative time, blood loss and complications', 'Intraoperative blood loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030471', 'cui_str': 'Nasal sinus structure'}, {'cui': 'C0282493', 'cui_str': 'Endoscopy with surgical procedure'}]","[{'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442972', 'cui_str': 'Imaging guidance'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0013838', 'cui_str': 'Electromagnetics'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0037710', 'cui_str': 'Auditory localization'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",,0.0202416,"Intraoperative blood loss (image-guidance group, 566.67 ± 62.23 ","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, All India Institute of Medical Sciences, Room no. 4057, ENT Office, 4th floor, Teaching Block, Ansari Nagar, New Delhi, 110029 India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, All India Institute of Medical Sciences, Room no. 4057, ENT Office, 4th floor, Teaching Block, Ansari Nagar, New Delhi, 110029 India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Thakar', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, All India Institute of Medical Sciences, Room no. 4057, ENT Office, 4th floor, Teaching Block, Ansari Nagar, New Delhi, 110029 India.'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Sharma', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, All India Institute of Medical Sciences, Room no. 4057, ENT Office, 4th floor, Teaching Block, Ansari Nagar, New Delhi, 110029 India.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Bhalla', 'Affiliation': 'Department of Radiodiagnosis, All India Institute of Medical Sciences, New Delhi, India.'}]",Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India,['10.1007/s12070-019-01773-0']
2889,32551300,The effect of ketamine versus thiopental sodium on hemodynamic profile and seizure duration during electroconvulsive therapy in patients with major depressive disorder: A randomized cross-over clinical trial.,"Background:  Electroconvulsive therapy (ECT) is an effective treatment in major depressive disorder (MDD). Earlier studies suggest that ketamine has antidepressive effects and prolongs seizure duration in favor of therapeutic efficacy of ECT. A great concern with the use of ketamine is its possible adverse hemodynamic effects during ECT. This study was conducted to compare the hemodynamic effect and seizure duration between ketamine and sodium thiopental, a common anesthetic in ECT.  Methods:  In a cross-over clinical trial, 26 patients of either sex with MDD who were candidates for ECT therapy in a university hospital were enrolled. A total of 13 patients received induction with ketamine in the first session and thiopental for the second. The sequence of treatments was vice versa in the other group. The followings were measured in all patients: blood pressure, heart rate, and oxygen saturation before induction, immediately after induction, at 1, 2, 4, and 10 minutes postinduction, and after recovery from anesthesia. Also, seizure duration, recovery time, and complications of treatments were measured. Chi square test and student t test were used for categorical data and numerical data, respectively. P values < 0.05 were considered statistically significant. Analyses were performed with SPSS software version 21.0.  Results:  Heart rate, systolic and diastolic blood pressure, oxygen saturation, and recovery time were comparable between groups. Mean duration of convulsion in patients who received ketamine was significantly more than those who received STP (36±11 vs 28±9 s, p=0.001). Myalgia was less common in patients who received ketamine rather than sodium thiopental (11.5 vs 46.2%, p=0.014).  Conclusion:  Ketamine prolongs seizure duration with no deleterious effects on hemodynamic parameters. Considering the antidepressant effects of ketamine, it may be a better choice, compared to thiopental sodium, for MDD patients.",2020,"Myalgia was less common in patients who received ketamine rather than sodium thiopental (11.5 vs 46.2%, p=0.014).  ","['major depressive disorder (MDD', '26 patients of either sex with MDD who were candidates for ECT therapy in a university hospital were enrolled', 'patients with major depressive disorder']","['electroconvulsive therapy', 'ketamine', 'Ketamine', 'Electroconvulsive therapy (ECT', 'sodium thiopental', 'ketamine and sodium thiopental', 'thiopental sodium']","['Heart rate, systolic and diastolic blood pressure, oxygen saturation, and recovery time', 'blood pressure, heart rate, and oxygen saturation', 'hemodynamic profile and seizure duration', 'Mean duration of convulsion', 'Myalgia', 'hemodynamic effect and seizure duration', 'seizure duration, recovery time, and complications of treatments', 'hemodynamic parameters']","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C1269683', 'cui_str': 'Major depressive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0936073', 'cui_str': 'Thiopental sodium'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",26.0,0.090045,"Myalgia was less common in patients who received ketamine rather than sodium thiopental (11.5 vs 46.2%, p=0.014).  ","[{'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Pournajafian', 'Affiliation': 'Department of Anesthesiology, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Faiz', 'Affiliation': 'Department of Anesthesiology, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Motazedi Ghajar', 'Affiliation': 'Department of Anesthesiology, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra Sadat', 'Initials': 'ZS', 'LastName': 'Koleini', 'Affiliation': 'Department of Anesthesiology, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Masood', 'Initials': 'M', 'LastName': 'Mohseni', 'Affiliation': 'Department of Anesthesiology, Iran University of Medical Sciences, Tehran, Iran.'}]",Medical journal of the Islamic Republic of Iran,['10.34171/mjiri.34.11']
2890,32551317,TREATMENT OUTCOME OF MANUAL VERSUS ROTARY TECHNIQUES IN SINGLE-VISIT ENDODONTICS FOR PATIENTS IN A NIGERIAN TEACHING HOSPITAL: A RANDOMIZED CLINICAL TRIAL.,"Background


Adequate canal preparation is essential in achieving successful outcome sequel to root canal treatment. Nickel-Titanium (NiTi) rotary instruments has steadily gained grounds in endodontics for root canals preparation, however, it is yet to be widely practiced among dental practitioners in Nigeria.
Aim and Objectives


To compare the treatment outcomes of single visit root canal treatment when either rotary or manual step-back preparation technique is used in shaping the canal, employing clinical and radiographic criteria.
Design of the study


A randomized controlled trial.
Setting


Conservation Unit of Restorative Dentistry Clinics, Lagos University Teaching Hospital (LUTH), Lagos, Nigeria.
Materials and Methods


120 consecutive consenting subjects were included in the study. The inclusion criteria were: medically fit individuals with restorable anterior, premolar or first molar tooth diagnosed with irreversible pulpitis, pulp necrosis or apical periodontitis; they had no to moderate pain, with periodontally sound and not excessively curved tooth. Randomization was performed by balloting using sealed envelopes and subjects were assigned in equal numbers to one of two groups, rotary and manual. Subjects were monitored following treatment for clinical and radiographic parameters at 1 day, 1 week, 1 month, 3 months and 6 months. Data analysis was done using SPSS-version 20.0, and differences were considered significant if p < 0.05.
Results


Twenty-seven (45%) and 23(38.3%) teeth in manual and rotary group respectively had pain at 1-day review. Significant difference in occurrence of pain in relation to both gender (p=0.001) and tooth-type (p=0.026) was noted between the groups at 1-day review. By the final review, there was no reported post-operative pain. There was no significant difference between the two groups in relation to the other clinical parameters at the different review periods. Twenty-four (40%) and 16 (26.7%) teeth had pre-existing periapical radiolucency in manual and rotary groups respectively; by final review, periapical radiolucency had reduced to 16.9% and 3.4% respectively, with the rotary group having significantly less radiolucency. Favourable outcome at 6-month review was significantly higher in the rotary group (96.6%), compared to the manual group (83.1%) in (p=0.033); the difference in outcome was due to significantly better outcomes with the molar tooth category in the rotary group.
Conclusion


There was a significantly more favourable treatment outcome in the rotary compared to the step-back technique in canal preparation, employing clinical and radiographic criteria.",2018,"There was a significantly more favourable treatment outcome in the rotary compared to the step-back technique in canal preparation, employing clinical and radiographic criteria.","['Setting\n\n\nConservation Unit of Restorative Dentistry Clinics, Lagos University Teaching Hospital (LUTH), Lagos, Nigeria', 'inclusion criteria were: medically fit individuals with restorable anterior, premolar or first molar tooth diagnosed with irreversible pulpitis, pulp necrosis or apical periodontitis; they had no to moderate pain, with periodontally sound and not excessively curved tooth', 'dental practitioners in Nigeria', '120 consecutive consenting subjects were included in the study']",['Nickel-Titanium (NiTi) rotary instruments'],"['pre-existing periapical radiolucency', 'periapical radiolucency', 'radiolucency', 'occurrence of pain']","[{'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C1171316', 'cui_str': 'Restorative dentistry'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0932487', 'cui_str': 'Structure of first molar tooth'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011407', 'cui_str': 'Necrosis of the pulp'}, {'cui': 'C0031030', 'cui_str': 'Apical periodontitis'}, {'cui': 'C0278139', 'cui_str': 'Moderate pain'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0011441', 'cui_str': 'Dentist'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0068790', 'cui_str': 'nitinol'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0729269', 'cui_str': 'Periapical'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",120.0,0.0766678,"There was a significantly more favourable treatment outcome in the rotary compared to the step-back technique in canal preparation, employing clinical and radiographic criteria.","[{'ForeName': 'J O', 'Initials': 'JO', 'LastName': 'Makanjuola', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dental Sciences, College of Medicine, University of Lagos, Nigeria.'}, {'ForeName': 'D C', 'Initials': 'DC', 'LastName': 'Umesi', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dental Sciences, College of Medicine, University of Lagos, Nigeria.'}, {'ForeName': 'O H', 'Initials': 'OH', 'LastName': 'Oderinu', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dental Sciences, College of Medicine, University of Lagos, Nigeria.'}]",Journal of the West African College of Surgeons,[]
2891,32551387,The effect of a 12-week resistance training intervention on leukocyte telomere length.,"Telomere dynamics are an active biological process and positive lifestyle factors such as exercise are proposed to potentiate their length. The aim of this study was to investigate the effect of a low-resistance, high-repetition resistance training intervention on leukocyte telomere length (LTL) and associated health parameters. 23 sedentary middle-aged adults volunteered for this study (16 female/7 male; age = 51.5 ± 4.9 years) and performed two one-hour sessions of Les Mills BODYPUMP™ per week for 12 weeks. Outcome measures were taken at baseline, after the training intervention and at 12-month follow-up. LTL remained unchanged following the training intervention (pre 0.819 ± 0.121 vs post 0.812 ± 0.114, p = 0.420), despite a borderline significant increase in hTERT expression (p = 0.050). Circulating levels of tumour necrosis factor alpha were reduced after the intervention (p = 0.001). At 12-month follow-up, subjects who returned to a sedentary lifestyle (n = 10) displayed shorter telomeres compared to their pre (p = 0.036) values. In conclusion, no changes were observed in LTL following the 12-week training intervention, despite improvements in molecular parameters associated with telomere dynamics. It appears continued long-term exercise (>12 months) is necessary to preserve LTL in previously sedentary individuals.",2020,Circulating levels of tumour necrosis factor alpha were reduced after the intervention (p = 0.001).,['23 sedentary middle-aged adults volunteered for this study (16 female/7 male; age = 51.5 ± 4.9 years'],"['low-resistance, high-repetition resistance training intervention', 'Les Mills BODYPUMP', 'resistance training intervention']","['leukocyte telomere length', 'Circulating levels of tumour necrosis factor alpha', 'leukocyte telomere length (LTL) and associated health parameters', 'hTERT expression', 'LTL']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0227192', 'cui_str': 'Inferior esophageal sphincter structure'}, {'cui': 'C0599997', 'cui_str': 'Mill'}]","[{'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",23.0,0.0170355,Circulating levels of tumour necrosis factor alpha were reduced after the intervention (p = 0.001).,"[{'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Nickels', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, Leicestershire, LE11 3TU, United Kingdom.'}, {'ForeName': 'Sarabjit', 'Initials': 'S', 'LastName': 'Mastana', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, Leicestershire, LE11 3TU, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hunter', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, Leicestershire, LE11 3TU, United Kingdom.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Denniff', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Veryan', 'Initials': 'V', 'LastName': 'Codd', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Akam', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, Leicestershire, LE11 3TU, United Kingdom.'}]",Heliyon,['10.1016/j.heliyon.2020.e04151']
2892,32551439,Cap-assisted endoscopic sclerotherapy for internal hemorrhoids: technique protocol and study design for a multi-center randomized controlled trial.,"Background


Cap-assisted endoscopic sclerotherapy is a new interventional therapy for internal hemorrhoids and rectal prolapse under colonoscopy. The proper length of the endoscopic injection needle is the core for performing cap-assisted endoscopic sclerotherapy well with more benefits and less complications. However, no data are currently available to guide endoscopists to consider the length of injection needle before cap-assisted endoscopic sclerotherapy. This study is designed to evaluate the efficacy and safety of cap-assisted endoscopic sclerotherapy with long or short injection needle in the treatment of internal hemorrhoids.
Methods


This is a nationwide multi-center, prospective, single-blind and randomized controlled trial. Patients with grade I-II internal hemorrhoids who have failed to conservative treatments and grade III internal hemorrhoids who are not suitable for surgery or refuse surgery will be included. Participants will be randomized 1:1 into either long or short injection needle group. The primary outcome is the recurrence rate of internal hemorrhoids 24 weeks after cap-assisted endoscopic sclerotherapy. The secondary outcomes are as follows: (1) symptom severity score, (2) three-level EuroQoL five dimensions health scale scores, (3) occurrence of adverse events and severe adverse events, and (4) patients' attitudes toward cap-assisted endoscopic sclerotherapy. Data collection will be conducted before and during operation, the 1st day, 1st week, 2nd week, and 24th week after cap-assisted endoscopic sclerotherapy.
Discussion


The outcome of this study is expected to provide a practical clinical protocol of cap-assisted endoscopic sclerotherapy for patients with internal hemorrhoids and promote the use of this new endoscopic technique.
Trial registration


ClinicalTrials.gov, NCT03917056. Registered on 12 April 2019.",2020,"This study is designed to evaluate the efficacy and safety of cap-assisted endoscopic sclerotherapy with long or short injection needle in the treatment of internal hemorrhoids.
","['patients with internal hemorrhoids', 'Patients with grade I-II internal hemorrhoids who have failed to conservative treatments and grade III internal hemorrhoids who are not suitable for surgery or refuse surgery will be included', 'internal hemorrhoids and rectal prolapse under colonoscopy']","['Cap-assisted endoscopic sclerotherapy', '\n\n\nCap-assisted endoscopic sclerotherapy', 'cap-assisted endoscopic sclerotherapy', 'cap-assisted endoscopic sclerotherapy with long or short injection needle']","['efficacy and safety', 'recurrence rate of internal hemorrhoids 24\u2009weeks after cap-assisted endoscopic sclerotherapy', ""1) symptom severity score, (2) three-level EuroQoL five dimensions health scale scores, (3) occurrence of adverse events and severe adverse events, and (4) patients' attitudes toward cap-assisted endoscopic sclerotherapy""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0265034', 'cui_str': 'Internal hemorrhoids'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0860132', 'cui_str': 'Internal hemorrhoids grade III'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0017095', 'cui_str': 'Trash'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034888', 'cui_str': 'Rectal prolapse'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0036435', 'cui_str': 'Injection of sclerosing agent'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0221093', 'cui_str': 'Hypodermic needle'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0265034', 'cui_str': 'Internal hemorrhoids'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0036435', 'cui_str': 'Injection of sclerosing agent'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.116234,"This study is designed to evaluate the efficacy and safety of cap-assisted endoscopic sclerotherapy with long or short injection needle in the treatment of internal hemorrhoids.
","[{'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Wen', 'Affiliation': 'Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Bota', 'Initials': 'B', 'LastName': 'Cui', 'Affiliation': 'Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yafei', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhong', 'Affiliation': 'Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Gastroenterology, First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, China.'}, {'ForeName': 'Lihao', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department of Gastroenterology, First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, China.'}, {'ForeName': 'Xiaoyin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Holistic Integrative Medicine, Third People's Hospital of Shenzhen, Shenzhen, China.""}, {'ForeName': 'Yunlian', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Gastroenterology, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, China.'}, {'ForeName': 'Muhan', 'Initials': 'M', 'LastName': 'Lv', 'Affiliation': 'Department of Gastroenterology, Affiliated Hospital of Southwest Medical University, Luzhou, China.'}, {'ForeName': 'Qianneng', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Department of Gastroenterology, Hangzhou Xixi Hospital, Hangzhou, China.'}, {'ForeName': 'Suyu', 'Initials': 'S', 'LastName': 'He', 'Affiliation': 'Fourth Department of the Digestive Disease Center, Suining Central Hospital, Suining, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': ""Department of Gastroenterology, Affiliated Hospital of Wuxi No. 2 People's Hospital of Nanjing Medical University, Wuxi, China.""}, {'ForeName': 'Shuxin', 'Initials': 'S', 'LastName': 'Tian', 'Affiliation': 'Department of Gastroenterology, First Affiliated Hospital of Shihezi University Medical College, Shihezi, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Wan', 'Affiliation': 'Department of Gastroenterology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Gastroenterology, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Gastroenterology and Hepatology, Shenzhen University General Hospital, Shenzhen, China.'}, {'ForeName': 'Jianling', 'Initials': 'J', 'LastName': 'Bai', 'Affiliation': 'Department of Biostatistics, School of Public Health, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Guangming', 'Initials': 'G', 'LastName': 'Huang', 'Affiliation': 'Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University, Nanjing, China; Key Lab of Holistic Integrative Enterology, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Guozhong', 'Initials': 'G', 'LastName': 'Ji', 'Affiliation': 'Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University, Nanjing, China; Key Lab of Holistic Integrative Enterology, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Faming', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Professor, Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University, 121 Jiangjiayuan, Nanjing 210011, China.'}]",Therapeutic advances in gastrointestinal endoscopy,['10.1177/2631774520925636']
2893,32551449,"Comparison of Intranasal Dexmedetomidine Versus Intranasal Ketamine as Premedication for Level of Sedation in Children Undergoing Radiation Therapy: A Prospective, Randomised, Double-Blind Study.","Objective


Radiation therapy is indicated in many solid tumours in children. Absolute immobility is required to precisely position children for optimal delivery of radiation energy to the target tissues, improve success rate and reduce the damage to nearby normal tissues. Intranasal (IN) administration of drugs is well tolerated, effective and fast acting. The primary aim of the present study was to evaluate the effectiveness of IN ketamine and dexmedetomidine for providing sedation in children before shifting to the radiotherapy suite. The secondary objective was to assess the requirement of propofol dosage in these patients.
Methods


A total of 243 children aged between 1 and 5 years scheduled to undergo external beam radiotherapy were randomised to receive 5 mg kg -1  ketamine (group K, n=80), 2.5 μg kg -1  dexmedetomidine (group D, n=85) or 0.5 ml of saline (group S, n=78) in each nostril. After 45 min, sedation score was measured according to the modified Ramsay score (MRS) at the time of shifting for radiation. Time to awakening and time to discharge after the procedure were also noted.
Results


A significantly higher proportion of children in group D (84.7%) achieved an MRS score ≥3 as compared to group K (36.2%) and group S (3.84%). The total propofol dose (mg kg -1 ) required was significantly less in group D (p<0.01). The patients in group D required more time to awakening, but this difference was not clinically significant.
Conclusion


The present study demonstrated that IN dexmedetomidine is superior to IN ketamine to provide procedural sedation for radiotherapy in children.",2020,The total propofol dose (mg kg -1 ) required was significantly less in group D (p<0.01).,"['children', 'Children Undergoing Radiation Therapy', '243 children aged between 1 and 5 years scheduled to undergo', 'many solid tumours in children', 'children before shifting to the radiotherapy suite']","['ketamine and dexmedetomidine', 'ketamine', 'Ketamine', '5 mg kg -1  ketamine', 'Intranasal Dexmedetomidine', 'external beam radiotherapy', 'saline', 'dexmedetomidine']","['MRS score ≥3', 'time to awakening', 'Level of Sedation', 'Time to awakening and time to discharge', 'sedation score', 'tolerated, effective and fast acting']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0333051', 'cui_str': 'Shift'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]",243.0,0.127153,The total propofol dose (mg kg -1 ) required was significantly less in group D (p<0.01).,"[{'ForeName': 'Praneeth', 'Initials': 'P', 'LastName': 'Suvvari', 'Affiliation': 'Department of Onco-Anaesthesia & Palliative Medicine, Dr BRA-Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Mishra', 'Affiliation': 'Department of Onco-Anaesthesia & Palliative Medicine, Dr BRA-Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sushma', 'Initials': 'S', 'LastName': 'Bhatnagar', 'Affiliation': 'Department of Onco-Anaesthesia & Palliative Medicine, Dr BRA-Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Garg', 'Affiliation': 'Department of Onco-Anaesthesia & Palliative Medicine, Dr BRA-Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sachidanand Jee', 'Initials': 'SJ', 'LastName': 'Bharati', 'Affiliation': 'Department of Onco-Anaesthesia & Palliative Medicine, Dr BRA-Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Nishkarsh', 'Initials': 'N', 'LastName': 'Gupta', 'Affiliation': 'Department of Onco-Anaesthesia & Palliative Medicine, Dr BRA-Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Vinod', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Department of Onco-Anaesthesia & Palliative Medicine, Dr BRA-Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Khan', 'Affiliation': 'Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}]",Turkish journal of anaesthesiology and reanimation,['10.5152/TJAR.2019.45087']
2894,32551725,Patterns of change and their relationship to outcome and follow-up in group and individual psychotherapy for depression.,"OBJECTIVE


The study explored the presence of different patterns of change in a sample of patients who received cognitive therapy for depression sequentially in two different formats: group and individual. Our hypothesis was that patients' baseline characteristics (e.g., symptom severity, self-esteem) would discriminate patterns of response to group and individual therapy.
METHOD


108 adults who met criteria for depression and completed the treatments included in a randomized controlled trial (RCT) were assessed with the Beck Depression Inventory-II (BDI-II), the Clinical Outcome in Routine Evaluation-Short Form B (CORE-SFB), the Global Assessment of Functioning (GAF), and the repertory grid technique. Growth mixture modeling was carried out to identify the patterns of change. Mixed linear models and repeated measures analysis of variance were performed to compare patients' characteristics in each pattern. Multinomial logistic regression was used to compute predictive models for the patterns from patients' characteristics. Finally, hierarchical linear regression was used to establish the power of each pattern to predict treatment outcome.
RESULTS


A 3-class solution was obtained: group therapy improvers, individual therapy improvers, and nonimprovers. Group therapy improvers started therapy with less severe levels of depression and psychological distress, higher functioning and self-esteem, lower perceived social isolation, and lower dilemmatic construction of the self than the other groups. Individual therapy improvers and nonimprovers presented similar characteristics at baseline. However, a significant proportion of nonimprovers presented a concurrent diagnosis of fibromyalgia.
CONCLUSION


The greater the impairment that patients present at baseline, the more likely they are to benefit from individual therapy after group therapy. A diagnosis of fibromyalgia can be considered a risk factor for therapy failure in the treatment of depression. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Group therapy improvers started therapy with less severe levels of depression and psychological distress, higher functioning and self-esteem, lower perceived social isolation, and lower dilemmatic construction of the self than the other groups.",['108 adults who met criteria for depression and completed the treatments'],"['Routine Evaluation-Short Form B (CORE-SFB', 'cognitive therapy']","['severe levels of depression and psychological distress, higher functioning and self-esteem, lower perceived social isolation, and lower dilemmatic construction of the self', 'Beck Depression Inventory-II (BDI-II']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0403066', 'cui_str': 'Construction worker'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}]",108.0,0.0521554,"Group therapy improvers started therapy with less severe levels of depression and psychological distress, higher functioning and self-esteem, lower perceived social isolation, and lower dilemmatic construction of the self than the other groups.","[{'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'Moggia', 'Affiliation': 'Department of Clinical Psychology and Psychobiology.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Lutz', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Arndt', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy.'}, {'ForeName': 'Guillem', 'Initials': 'G', 'LastName': 'Feixas', 'Affiliation': 'Department of Clinical Psychology and Psychobiology.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000562']
2895,32551730,"Prequestions enhance learning, but only when they are remembered.","Answering prequestions benefits learning, but this benefit is mostly specific to material that was relevant to the prequestions (prequestioned material) and does not extend to other, nonprequestioned material. The current study examined whether this specific benefit is due to selective processing of prequestioned information during a learning experience. In 4 experiments, participants were assigned to a prequestion group or control group before viewing a 30-min video lecture. In Experiment 2, participants were instructed to take notes on information they thought was important during the video; in Experiment 3, the prequestion group was instructed to write down the answers to the prequestions; and in Experiment 4, the prequestion group was given the prequestions and instructed to answer them while viewing the video. On a later posttest in all experiments, the prequestion group outperformed the control group, but only for prequestioned material. Further, this benefit only occurred when the prequestion group successfully discovered the answers to the prequestions during the video by writing them down (Experiments 2 and 3) or circling them (Experiment 4). These results suggest that prequestion benefits depend on the degree to which participants can successfully notice and discover the answers to the prequestioned material during a video lecture. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"On a later posttest in all experiments, the prequestion group outperformed the control group, but only for prequestioned material.",[],"['prequestion group or control group before viewing a 30-min video lecture', 'prequestion group was given the prequestions and instructed to answer them while viewing the video']",[],[],"[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C1947971', 'cui_str': 'Give'}]",[],,0.0163468,"On a later posttest in all experiments, the prequestion group outperformed the control group, but only for prequestioned material.","[{'ForeName': 'Kyle J', 'Initials': 'KJ', 'LastName': 'St Hilaire', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Shana K', 'Initials': 'SK', 'LastName': 'Carpenter', 'Affiliation': 'Department of Psychology.'}]",Journal of experimental psychology. Applied,['10.1037/xap0000296']
2896,32551736,A randomized controlled trial of the effectiveness of virtually delivered Body Project (vBP) groups to prevent eating disorders.,"OBJECTIVES


To investigate the effectiveness of Body Project groups delivered virtually (vBP) by peer educators for prevention of eating disorders.
METHOD


In a randomized controlled trial vBP groups (N = 149) were compared with a placebo (expressive writing, EW: N = 148) over 24-month follow-up and to a waitlist control condition (N = 146) over 6-month follow-up among females (15-20 years old) with body image concerns. The primary outcome was incidence of eating disorder onset over 2-year follow-up measured by blinded diagnostic interviews. Waitlist participants were offered the vBP after 6 months.
RESULTS


The incidence of eating disorders onset over 24 months follow up were 3 in vBP (2.0%) and 13 in EW (8.8%), a significant difference; Hazard Ratio (Experiment B) = 0.26, 95% confidence interval (CI) [0.075, 0.92], p = .037. Incidence of eating disorder onset in vBP participants was 77% less than in EW participants. The vBP participants generally showed significantly greater reduction in eating disorder symptoms, clinical impairment, body dissatisfaction, and internalization of thin ideal compared with the waitlist participants at postintervention and 6-month follow-up, and in eating disorder symptoms, restraint, body dissatisfaction, and internalization of thin ideal compared with the EW participants at postintervention, and 6-, 12-, 18-, or 24-months follow-up. EW participants reported significantly greater reduction in clinical impairment and body dissatisfaction at postintervention compared with the waitlist participants.
CONCLUSIONS


The present reduction in the incidence of eating disorders is notable given that the intervention was implemented virtually, rather than in-person. The vBP might be a viable option for future evaluation of scalable prevention of eating disorders. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"The vBP participants generally showed significantly greater reduction in eating disorder symptoms, clinical impairment, body dissatisfaction, and internalization of thin ideal compared with the waitlist participants at postintervention and 6-month follow-up, and in eating disorder symptoms, restraint, body dissatisfaction, and internalization of thin ideal compared with the EW participants at postintervention, and 6-, 12-, 18-, or 24-months follow-up.",['N = 146) over 6-month follow-up among females (15-20 years old) with body image concerns'],"['placebo (expressive writing, EW: N = 148) over 24-month follow-up and to a waitlist control condition', 'virtually delivered Body Project (vBP']","['eating disorder symptoms, restraint, body dissatisfaction, and internalization of thin ideal', 'incidence of eating disorder onset over 2-year follow-up measured by blinded diagnostic interviews', 'eating disorder symptoms, clinical impairment, body dissatisfaction, and internalization of thin ideal', 'incidence of eating disorders', 'eating disorders', 'clinical impairment and body dissatisfaction', 'incidence of eating disorders onset', 'Incidence of eating disorder onset']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0072634', 'cui_str': 'PVB protocol'}]","[{'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",149.0,0.0645106,"The vBP participants generally showed significantly greater reduction in eating disorder symptoms, clinical impairment, body dissatisfaction, and internalization of thin ideal compared with the waitlist participants at postintervention and 6-month follow-up, and in eating disorder symptoms, restraint, body dissatisfaction, and internalization of thin ideal compared with the EW participants at postintervention, and 6-, 12-, 18-, or 24-months follow-up.","[{'ForeName': 'Ata', 'Initials': 'A', 'LastName': 'Ghaderi', 'Affiliation': 'Division of Psychology.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Stice', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Andersson', 'Affiliation': 'Department of Clinical Neuroscience.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Enö Persson', 'Affiliation': 'Department of Clinical Neuroscience.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Allzén', 'Affiliation': 'Stockholm University Brain Imaging Centre.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000506']
2897,32551796,Usefulness of Ninjin'yoeito for Chronic Obstructive Pulmonary Disease Patients with Frailty.,"Objectives:  Frail patients with chronic obstructive pulmonary disease (COPD) have a higher risk of mortality, mood disorder, and poor quality of life (QOL). There are few intervention studies in frail patients with COPD, and there is a need for an effective therapy. Ninjin'yoeito (NYT) is a Kampo medicine that has been reported to improve fatigue, psychosomatic vulnerability, and respiratory symptoms. We examined the efficacy of NYT in frailty or prefrailty patients with COPD.  Design:  Prospective, single-center, open-label, randomized controlled trial.  Location:  Showa University Hospital, Tokyo, Japan.  Subjects:  Sixty-two patients (53 males and 9 females) with a mean age of 76 ± 6 years were included in the analysis.  Interventions:  The patients were divided into two groups: the NYT group ( n  = 31) and the control (standard treatment) group ( n  = 31).  Outcome measures:  The primary outcome was changes in Kihon checklist (KCL) scores at week 24, which reflect changes in frailty. The secondary outcomes were changes in the following assessment scores at week 24: Simplified Nutritional Appetite Questionnaire (SNAQ) scores, which reflect changes in appetite; COPD Assessment Test (CAT) scores, which reflect changes in QOL in patients with COPD; Hospital Anxiety and Depression Scale (HADS)-Anxiety scores, which reflect changes in anxiety; and HADS-Depression scores, which reflect changes in depression.  Results:  There was a slight but not significant difference in changes in KCL scores between the NYT and control groups ( p  = 0.09). However, there were statistically significant differences in changes in SNAQ ( p  = 0.03), CAT ( p  = 0.03), HADS-Anxiety ( p  < 0.01), and HADS-Depression ( p  = 0.02) scores between the two groups.  Conclusions:  Our results suggest that NYT is an effective and promising drug with various effects in patients with COPD who are frail, despite conventional treatment.",2020,"However, there were statistically significant differences in changes in SNAQ ( p  = 0.03), CAT ( p  = 0.03), HADS-Anxiety ( p  < 0.01), and HADS-Depression ( p  = 0.02) scores between the two groups.  ","['Chronic Obstructive Pulmonary Disease Patients with Frailty', 'patients with COPD who are frail, despite conventional treatment', 'frailty or prefrailty patients with COPD', 'Frail patients with chronic obstructive pulmonary disease (COPD', 'frail patients with COPD', 'Subjects:  Sixty-two patients (53 males and 9 females) with a mean age of 76\u2009±\u20096 years were included in the analysis']","[""Ninjin'yoeito""]","['KCL scores', 'Simplified Nutritional Appetite Questionnaire (SNAQ) scores, which reflect changes in appetite; COPD Assessment Test (CAT) scores, which reflect changes in QOL in patients with COPD; Hospital Anxiety and Depression Scale (HADS)-Anxiety scores, which reflect changes in anxiety; and HADS-Depression scores', 'SNAQ', 'risk of mortality, mood disorder, and poor quality of life (QOL', 'HADS-Anxiety', 'HADS-Depression', 'changes in Kihon checklist (KCL) scores']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",[],"[{'cui': 'C0032825', 'cui_str': 'Potassium Chloride'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0426587', 'cui_str': 'Altered appetite'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0525045', 'cui_str': 'Mood disorder'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]",,0.0350023,"However, there were statistically significant differences in changes in SNAQ ( p  = 0.03), CAT ( p  = 0.03), HADS-Anxiety ( p  < 0.01), and HADS-Depression ( p  = 0.02) scores between the two groups.  ","[{'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Hirai', 'Affiliation': 'Division of Respiratory Medicine and Allergology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Homma', 'Affiliation': 'Division of Respiratory Medicine and Allergology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Matsunaga', 'Affiliation': 'Division of Respiratory Medicine and Allergology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kaho', 'Initials': 'K', 'LastName': 'Akimoto', 'Affiliation': 'Division of Respiratory Medicine and Allergology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shigenori', 'Initials': 'S', 'LastName': 'Yamamoto', 'Affiliation': 'Division of Respiratory Medicine and Allergology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiromitsu', 'Initials': 'H', 'LastName': 'Suganuma', 'Affiliation': 'Division of Respiratory Medicine and Allergology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Ayaka', 'Initials': 'A', 'LastName': 'Kashima', 'Affiliation': 'Division of Respiratory Medicine and Allergology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Sato', 'Affiliation': 'Division of Respiratory Medicine and Allergology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takaya', 'Initials': 'T', 'LastName': 'Ebato', 'Affiliation': 'Division of Respiratory Medicine and Allergology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yoshito', 'Initials': 'Y', 'LastName': 'Miyata', 'Affiliation': 'Division of Respiratory Medicine and Allergology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Ohta', 'Affiliation': 'Division of Respiratory Medicine and Allergology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Inoue', 'Affiliation': 'Division of Respiratory Medicine and Allergology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Sojiro', 'Initials': 'S', 'LastName': 'Kusumoto', 'Affiliation': 'Division of Respiratory Medicine and Allergology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Suzuki', 'Affiliation': 'Division of Respiratory Medicine and Allergology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Tanaka', 'Affiliation': 'Division of Respiratory Medicine and Allergology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Sagara', 'Affiliation': 'Division of Respiratory Medicine and Allergology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2020.0083']
2898,32551817,Machine Learning Classifier Models Can Identify ARDS Phenotypes Using Readily Available Clinical Data.,"RATIONALE


Two distinct phenotypes of ARDS with differential clinical outcomes and responses to randomly assigned treatment have consistently been identified in randomized controlled trial (RCT) cohorts using latent class analysis (LCA). Plasma biomarkers, key components in phenotype identification, currently lack point-of-care assays and represent a barrier to the clinical implementation of phenotypes. The objective of this study was to develop models to classify ARDS phenotypes using readily-available clinical data only.
METHODS


Three RCT cohorts served as the training dataset (ARMA, ALVEOLI, and FACTT, n=2022), and a fourth as the validation dataset (SAILS, n = 745). A gradient-boosted machine algorithm was used to develop classifier models using 24 variables (demographics, vital signs, laboratory, and respiratory variables) at enrollment. As secondary analyses, ALVEOLI and FACTT each served as the validation dataset and the remaining combined cohorts formed the training dataset for each analysis. Model performance was evaluated against LCA-derived phenotype.
RESULTS


For the primary analysis, the model accurately classified phenotypes in the validation cohort (AUC 0.95, CI:0.94-0.96). Using a probability cut-off of 0.5 to assign class, inflammatory biomarkers (Interleukin-6, Interleukin-8, Protein C, and sTNFR-1; p<0.0001) and 90-day mortality (38% vs 24%, p=0.0002) were significantly higher in the hyperinflammatory phenotype as classified by the model. Model accuracy was similar when ALVEOLI (AUC 0.94, CI:0.92-0.96) and FACTT (AUC 0.94, CI:0.92-0.95) were the validation cohorts. Significant treatment interactions were observed with the clinical-classifier model assigned phenotypes in both ALVEOLI (p=0.0113) and FACTT (p=0.0072).
CONCLUSION


ARDS phenotypes can be accurately identified using machine learning models based on readily-available clinical data and may enable rapid phenotype identification at the bedside.",2020,"Model accuracy was similar when ALVEOLI (AUC 0.94, CI:0.92-0.96) and FACTT (AUC 0.94, CI:0.92-0.95) were the validation cohorts.",[],[],"['inflammatory biomarkers (Interleukin-6, Interleukin-8, Protein C, and sTNFR-1; p<0.0001) and 90-day mortality', 'Model accuracy']",[],[],"[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0033621', 'cui_str': 'Protein C'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",,0.0627125,"Model accuracy was similar when ALVEOLI (AUC 0.94, CI:0.92-0.96) and FACTT (AUC 0.94, CI:0.92-0.95) were the validation cohorts.","[{'ForeName': 'Pratik', 'Initials': 'P', 'LastName': 'Sinha', 'Affiliation': 'University of California San Francisco Medical Center at Parnassus, 43166, Division of Pulmonary and Critical Care, San Francisco, California, United States; pratik.sinha@ucsf.edu.'}, {'ForeName': 'Matthew M', 'Initials': 'MM', 'LastName': 'Churpek', 'Affiliation': 'University of Wisconsin Madison, 5228, Madison, Wisconsin, United States.'}, {'ForeName': 'Carolyn S', 'Initials': 'CS', 'LastName': 'Calfee', 'Affiliation': 'UCSF, Medicine, San Francisco, California, United States.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202002-0347OC']
2899,32551819,A randomised trial of dialectical behaviour therapy and the conversational model for the treatment of borderline personality disorder with recent suicidal and/or non-suicidal self-injury: An effectiveness study in an Australian public mental health service.,"OBJECTIVES


Borderline personality disorder is a complex mental disorder that is associated with a high degree of suffering for the individual. Dialectical behaviour therapy has been studied in the largest number of controlled trials for treatment of individuals with borderline personality disorder. The conversational model is a psychodynamic treatment also developed specifically for treatment of borderline personality disorder. We report on the outcomes of a randomised trial comparing dialectical behaviour therapy and conversational model for treatment of borderline personality disorder in a routine clinical setting.
METHOD


Participants had a diagnosis of borderline personality disorder and a minimum of three suicidal and/or non-suicidal self-injurious episodes in the previous 12 months. Consenting individuals were randomised to either dialectical behaviour therapy or conversational model and contracted for 14 months of treatment ( n  = 162 commenced therapy). Dialectical behaviour therapy involved participants attending weekly individual therapy, weekly group skills training and having access to after-hours phone coaching. Conversational model involved twice weekly individual therapy. Assessments occurred at baseline, mid-treatment (7 months) and post-treatment (14 months). Assessments were conducted by a research assistant blind to treatment condition. Primary outcomes were change in suicidal and non-suicidal self-injurious episodes and severity of depression. We hypothesised that dialectical behaviour therapy would be more effective in reducing suicidal and non-suicidal self-injurious behaviour and that conversational model would be more effective in reducing depression.
RESULTS


Both treatments showed significant improvement over time across the 14 months duration of therapy in suicidal and non-suicidal self-injury and depression scores. There were no significant differences between treatment models in reduction of suicidal and non-suicidal self-injury. However, dialectical behaviour therapy was associated with significantly greater reductions in depression scores compared to conversational model.
CONCLUSION


This research adds to the accumulating body of knowledge of psychotherapeutic treatment of borderline personality disorder and supports the use of both dialectical behaviour therapy and conversational model as effective treatments in routine clinical settings, with some additional benefits for dialectical behaviour therapy for persons with co-morbid depression.",2020,Both treatments showed significant improvement over time across the 14 months duration of therapy in suicidal and non-suicidal self-injury and depression scores.,"['Participants had a diagnosis of borderline personality disorder and a minimum of three suicidal and/or non-suicidal self-injurious episodes in the previous 12\u2009months', 'Australian public mental health service', 'borderline personality disorder with recent suicidal and/or non-suicidal self-injury', 'participants attending weekly', 'individuals with borderline personality disorder', 'persons with co-morbid depression', 'Consenting individuals']","['dialectical behaviour therapy and the conversational model', 'dialectical behaviour therapy and conversational model', 'Dialectical behaviour therapy', 'dialectical behaviour therapy or conversational model', 'individual therapy, weekly group skills training and having access to after-hours phone coaching', 'dialectical behaviour therapy']","['reduction of suicidal and non-suicidal self-injury', 'change in suicidal and non-suicidal self-injurious episodes and severity of depression', 'depression scores', 'suicidal and non-suicidal self-injury and depression scores']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0085271', 'cui_str': 'Self-injurious behavior'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C1321145', 'cui_str': 'Dialectical behavior therapy'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0204525', 'cui_str': 'Individual psychotherapy'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0085271', 'cui_str': 'Self-injurious behavior'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.018075,Both treatments showed significant improvement over time across the 14 months duration of therapy in suicidal and non-suicidal self-injury and depression scores.,"[{'ForeName': 'Carla J', 'Initials': 'CJ', 'LastName': 'Walton', 'Affiliation': 'Centre for Psychotherapy, Hunter New England Mental Health Service, Newcastle, NSW, Australia.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Bendit', 'Affiliation': 'Centre for Psychotherapy, Hunter New England Mental Health Service, Newcastle, NSW, Australia.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Baker', 'Affiliation': 'School of Medicine and Public Health, The University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Carter', 'Affiliation': 'Priority Research Centre for Brain and Mental Health Research, The University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Terry J', 'Initials': 'TJ', 'LastName': 'Lewin', 'Affiliation': 'Priority Research Centre for Brain and Mental Health Research, The University of Newcastle, Callaghan, NSW, Australia.'}]",The Australian and New Zealand journal of psychiatry,['10.1177/0004867420931164']
2900,31505519,Personality as a Predictor of Treatment Response to Escitalopram in Adults With Body Dysmorphic Disorder.,"OBJECTIVE


Serotonin reuptake inhibitors (SRIs) are the first-line pharmacotherapy for body dysmorphic disorder (BDD), a common and severe disorder. However, predictors and correlates of treatment response are not well understood. A closer examination of baseline personality dimensions and disorders and of changes in personality during SRI treatment is needed to advance knowledge of this clinically important issue.
METHOD


We conducted a secondary analysis of data from a pharmacotherapy relapse prevention trial of the SRI escitalopram in adults with BDD to examine personality dimensions and traits, as well as whether these variables predict and correlate with treatment response. A total of 65 participants with BDD completed the Revised NEO Personality Inventory (NEO PI-R) before starting open-label treatment with escitalopram and 42 participants completed the NEO PI-R after treatment.
RESULTS


At baseline, participants with BDD displayed higher levels of neuroticism and lower levels of extraversion than a normed reference group. Higher baseline neuroticism was a significant predictor of nonresponse to escitalopram treatment, even when baseline depression severity was controlled for. Changes in neuroticism were not associated with treatment response.
CONCLUSION


Our findings underscore the relationship between BDD and neuroticism, and they suggest a link between neuroticism and SRI treatment response.",2019,"At baseline, participants with BDD displayed higher levels of neuroticism and lower levels of extraversion than a normed reference group.","['Adults With Body Dysmorphic Disorder', 'adults with BDD', '65 participants with BDD completed the']","['Serotonin reuptake inhibitors (SRIs', 'SRI escitalopram']","['levels of neuroticism and lower levels of extraversion', 'Revised NEO Personality Inventory (NEO PI-R']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005887', 'cui_str': 'Body dysmorphic disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0162758', 'cui_str': 'Serotonin uptake inhibitor'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}]","[{'cui': 'C0564509', 'cui_str': 'Level of neuroticism'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0564508', 'cui_str': 'Level of extraversion'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0003944', 'cui_str': 'As If Personality'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",65.0,0.075114,"At baseline, participants with BDD displayed higher levels of neuroticism and lower levels of extraversion than a normed reference group.","[{'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Fang', 'Affiliation': 'FANG, PORTH, WILHELM: Massachusetts General Hospital/Harvard Medical School, Boston, MA PHILLIPS: New York-Presbyterian Hospital and Weill Cornell Medical College, New York, NY and Rhode Island Hospital and Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Porth', 'Affiliation': ''}, {'ForeName': 'Katharine A', 'Initials': 'KA', 'LastName': 'Phillips', 'Affiliation': ''}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Wilhelm', 'Affiliation': ''}]",Journal of psychiatric practice,['10.1097/PRA.0000000000000415']
2901,31505520,Accuracy of Anxiety Disorder Not Otherwise Specified Diagnosis in Older Veterans.,"We examined the accuracy of the anxiety not otherwise specified (anxiety NOS) diagnosis in 61 patients, using data from older Veterans screened for a large trial of cognitive behavioral therapy for late-life generalized anxiety disorder. We compared the anxiety NOS diagnoses based on the electronic medical record to diagnoses obtained via a gold standard structured diagnostic interview conducted for this trial. We found concordance of the anxiety NOS diagnosis in only 2 participants (3%). Most patients (77%) met diagnostic criteria for a specific Diagnostic & Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) anxiety disorder, including generalized anxiety disorder, posttraumatic stress disorder, panic disorder, and/or social anxiety disorder, on the basis of a structured diagnostic interview. The erroneous diagnosis of anxiety NOS is a barrier to patients receiving appropriate evidence-based care for specific anxiety-related and trauma-related disorders. Undertreated anxiety can result in poorer health outcomes, overutilization of medical services, and increased health care costs. Accurate diagnosis of anxiety disorders is foundational to evidence-based treatment; thus, it is imperative that patients presenting with anxiety symptoms receive proper diagnostic assessment to facilitate access to the appropriate evidence-based mental health services.",2019,We found concordance of the anxiety NOS diagnosis in only 2 participants (3%).,"['Most patients (77%) met diagnostic criteria for a specific Diagnostic & Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) anxiety disorder, including generalized anxiety disorder, posttraumatic stress disorder, panic disorder, and/or social anxiety disorder', '61 patients, using data from older Veterans screened for a large trial of cognitive behavioral therapy for late-life generalized anxiety disorder', 'patients presenting with anxiety symptoms', 'Older Veterans']",[],"['anxiety NOS diagnoses', 'Accuracy of Anxiety Disorder', 'health care costs', 'anxiety NOS diagnosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0441797', 'cui_str': 'Fourth edition'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}]",,0.0204269,We found concordance of the anxiety NOS diagnosis in only 2 participants (3%).,"[{'ForeName': 'Terri L', 'Initials': 'TL', 'LastName': 'Fletcher', 'Affiliation': 'FLETCHER, HUNDT, KUNIK, STANLEY: Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey VA Medical Center (MEDVAMC 152), Houston, TX; Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX; and South Central Mental Illness Research, Education and Clinical Center (a virtual center), Houston, TX SINGH: Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey VA Medical Center (MEDVAMC 152), Houston, TX and Department of Medicine, Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Natalie E', 'Initials': 'NE', 'LastName': 'Hundt', 'Affiliation': ''}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Kunik', 'Affiliation': ''}, {'ForeName': 'Hardeep', 'Initials': 'H', 'LastName': 'Singh', 'Affiliation': ''}, {'ForeName': 'Melinda A', 'Initials': 'MA', 'LastName': 'Stanley', 'Affiliation': ''}]",Journal of psychiatric practice,['10.1097/PRA.0000000000000408']
2902,31567622,Making a Correct Diagnosis of Glaucoma: Data From the EMGT.,"PRéCIS:: A correct diagnosis of glaucoma established at initial visits.
PURPOSE


It has been suggested that a diagnosis of glaucoma cannot be certain until progression has been demonstrated. Our aim was to evaluate the correctness of a glaucoma diagnosis established after 2 initial visits.
PATIENTS AND METHODS


Patients included in the Early Manifest Glaucoma Trial (EMGT) who had continued follow-up for at least 15 years were included in this analysis. The patients had been recruited primarily through a population screening and were diagnosed with glaucoma if the Glaucoma Hemifield Test was outside normal limits in the same sector at two consecutive visits. A Glaucoma Hemifield Test classification of borderline was also diagnostic if corresponding optic disc findings were present. At least one of the following criteria had to be fulfilled during follow-up to confirm the initial diagnosis: (1) visual field progression in at least one eye according to the EMGT criterion; (2) development of manifest glaucoma in an initially ineligible fellow eye; (3) optic disc progression in at least one eye; (4) optic disc hemorrhages in at least 1 eye.
RESULTS


Of the 255 patients included in the EMGT, 117 were followed for at least 15 years, representing 147 eyes eligible for our study. During follow-up, 134 eyes (91%) showed visual field progression, and, of the remaining 13 eyes, only 4 (3%) did not fulfill any of the criteria to confirm the diagnosis.
CONCLUSIONS


A diagnosis made applying strict criteria to 2 initial visual field tests, supported by optic disc findings if visual field findings were borderline, was almost always correct.",2019,"During follow-up, 134 eyes (91%) showed visual field progression, and, of the remaining 13 eyes, only 4 (3%) did not fulfill any of the criteria to confirm the diagnosis.
","['Patients included in the Early Manifest Glaucoma Trial (EMGT) who had continued follow-up for at least 15 years', 'patients had been recruited primarily through a population screening and were diagnosed with glaucoma if the Glaucoma Hemifield Test was outside normal limits in the same sector at two consecutive visits', '255 patients included in the', ' 117 were followed for at least 15 years, representing 147 eyes eligible for our study']",['EMGT'],['visual field progression'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1827222', 'cui_str': 'Glaucoma hemifield test'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0442816', 'cui_str': 'Normal limits'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",255.0,0.0450836,"During follow-up, 134 eyes (91%) showed visual field progression, and, of the remaining 13 eyes, only 4 (3%) did not fulfill any of the criteria to confirm the diagnosis.
","[{'ForeName': 'HannaMaria', 'Initials': 'H', 'LastName': 'Öhnell', 'Affiliation': 'Department of Clinical Sciences in Malmö, Ophthalmology, Lund University.'}, {'ForeName': 'Boel', 'Initials': 'B', 'LastName': 'Bengtsson', 'Affiliation': 'Department of Clinical Sciences in Malmö, Ophthalmology, Lund University.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Heijl', 'Affiliation': 'Department of Clinical Sciences in Malmö, Ophthalmology, Lund University.'}]",Journal of glaucoma,['10.1097/IJG.0000000000001342']
2903,31604115,Endogenous production of C-C motif chemokine ligand 2 by nasopharyngeal carcinoma cells drives radioresistance-associated metastasis.,"Patients with recurrent nasopharyngeal carcinoma (NPC) have more co-existing distant metastasis than those of no-recurrence and are more likely to suffer distant metastasis after re-irradiation than patients with newly diagnosed NPC. However, the relationship between radioresistance and distant metastasis and the mechanisms involved in radioresistance-associated metastasis are still unclear. In this study, we proved that C-C motif chemokine ligand 2 (CCL2) expression was significantly elevated in HONE1-IR cells and recurrent NPC tumour. Inhibition of CCL2 enhanced sensitivity to radiotherapy in NPC cells. Moreover, autocrine CCL2 promoted NPC cell adaptive radioresistance, metastasis and epithelial-mesenchymal transition. Additionally, p53 activated CCL2 transcription. High CCL2 expression was highly associated with poorer locoregional recurrence free survival, progression free survival and overall survival in patients with newly diagnosed NPC. Notably, high CCL2 expression was an independent prognostic factor for distant metastasis free survival in recurrent NPC patients. Our results provide insights into the autocrine signalling mechanisms of CCL2 and suggest that inhibition of autocrine CCL2 may be a candidate treatment strategy for management of radioresistant NPC.",2020,"High CCL2 expression was highly associated with poorer locoregional recurrence free survival, progression free survival and overall survival in patients with newly diagnosed NPC.","['patients with newly diagnosed NPC', 'Patients with recurrent nasopharyngeal carcinoma (NPC']",['radiotherapy'],"['locoregional recurrence free survival, progression free survival and overall survival', 'NPC cell adaptive radioresistance, metastasis and epithelial-mesenchymal transition', 'HONE1-IR cells and recurrent NPC tumour']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0278952', 'cui_str': 'Nasopharyngeal cancer recurrent'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1523298', 'cui_str': 'Epithelial-Mesenchymal Transformation'}, {'cui': 'C0278952', 'cui_str': 'Nasopharyngeal cancer recurrent'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]",,0.0576527,"High CCL2 expression was highly associated with poorer locoregional recurrence free survival, progression free survival and overall survival in patients with newly diagnosed NPC.","[{'ForeName': 'Shan-Shan', 'Initials': 'SS', 'LastName': 'Guo', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, 651 Dongfeng Road East, Guangzhou, 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou, 510060, PR China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, 651 Dongfeng Road East, Guangzhou, 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou, 510060, PR China.'}, {'ForeName': 'Yue-Feng', 'Initials': 'YF', 'LastName': 'Wen', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, 651 Dongfeng Road East, Guangzhou, 510060, PR China; Department of Radiotherapy, Affiliated Cancer Hospital & Institute of Guangzhou Medical University, 78 Hengzhigang Road, Guangzhou, 510095, PR China.'}, {'ForeName': 'Li-Ting', 'Initials': 'LT', 'LastName': 'Liu', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, 651 Dongfeng Road East, Guangzhou, 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou, 510060, PR China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yuan', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, 651 Dongfeng Road East, Guangzhou, 510060, PR China.'}, {'ForeName': 'Yan-Xian', 'Initials': 'YX', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Translational Radiation Oncology, Hunan Cancer Hospital and the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, 410013, PR China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Radiotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & the Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, 210009, PR China.'}, {'ForeName': 'Wen-Wen', 'Initials': 'WW', 'LastName': 'Hao', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, 651 Dongfeng Road East, Guangzhou, 510060, PR China.'}, {'ForeName': 'Jing-Yun', 'Initials': 'JY', 'LastName': 'Peng', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, 651 Dongfeng Road East, Guangzhou, 510060, PR China.'}, {'ForeName': 'Dan-Ni', 'Initials': 'DN', 'LastName': 'Chen', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, 651 Dongfeng Road East, Guangzhou, 510060, PR China.'}, {'ForeName': 'Qing-Nan', 'Initials': 'QN', 'LastName': 'Tang', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, 651 Dongfeng Road East, Guangzhou, 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou, 510060, PR China.'}, {'ForeName': 'Xue-Song', 'Initials': 'XS', 'LastName': 'Sun', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, 651 Dongfeng Road East, Guangzhou, 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou, 510060, PR China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, 651 Dongfeng Road East, Guangzhou, 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou, 510060, PR China.'}, {'ForeName': 'Hao-Yuan', 'Initials': 'HY', 'LastName': 'Mo', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, 651 Dongfeng Road East, Guangzhou, 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou, 510060, PR China.'}, {'ForeName': 'Chao-Nan', 'Initials': 'CN', 'LastName': 'Qian', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, 651 Dongfeng Road East, Guangzhou, 510060, PR China.'}, {'ForeName': 'Mu-Sheng', 'Initials': 'MS', 'LastName': 'Zeng', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, 651 Dongfeng Road East, Guangzhou, 510060, PR China.'}, {'ForeName': 'Jin-Xin', 'Initials': 'JX', 'LastName': 'Bei', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, 651 Dongfeng Road East, Guangzhou, 510060, PR China.'}, {'ForeName': 'Shu-Yang', 'Initials': 'SY', 'LastName': 'Sun', 'Affiliation': ""Department of Oral and Maxillofacial-Head Neck Oncology, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, 200011, PR China.""}, {'ForeName': 'Qiu-Yan', 'Initials': 'QY', 'LastName': 'Chen', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, 651 Dongfeng Road East, Guangzhou, 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou, 510060, PR China.'}, {'ForeName': 'Lin-Quan', 'Initials': 'LQ', 'LastName': 'Tang', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, 651 Dongfeng Road East, Guangzhou, 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou, 510060, PR China.'}, {'ForeName': 'Hai-Qiang', 'Initials': 'HQ', 'LastName': 'Mai', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, 651 Dongfeng Road East, Guangzhou, 510060, PR China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou, 510060, PR China. Electronic address: maihq@sysucc.org.cn.'}]",Cancer letters,['10.1016/j.canlet.2019.10.008']
2904,32560171,Long-Term Socioeconomic Impact of Informal Care Provided to Patients with Pacemakers: Remote vs. Conventional Monitoring.,"The impact of informal care immediately after pacemaker (PM) implantation has been well established; however, not much is known about its long-term effects. The present study compared personal characteristics, associated problems, workloads, time, and costs related to informal care provided to patients with PM under remote monitoring (RM) vs. conventional monitoring (CM) in the hospital, five years after implantation. The PONIENTE study was a controlled, non-randomized or masked clinical trial conducted with information obtained from the perspective of informal caregivers. Data were collected at 12 and 60 months after PM implantation. The patients in the study were assigned to two different groups: remote monitoring (RM) and conventional monitoring (CM). The ""Disability, personal autonomy, and dependency situations survey"" (EDAD) was administered to collect information on sociodemographic characteristics, time, care difficulties, health status, professional aspects, and impact on economic, family, or leisure aspects of the main caregivers providing care to patients with pacemakers. After five years, 55 patients completed the study (RM = 21; CM = 34). The average age was 63.14 years (SD = 14.90), 96% of them were women, and the most predominant marital status was married (72%). Informal caregivers lived in the homes of the patients in 70% of cases, and 88% indicated that they had to provide care six to seven days a week. The average cost per patient during the monitoring period studied was 13.17% lower in the RM group than in the CM group, and these differences were not statistically significant ( p  = 0.35). This study found similar results in the two groups under study with respect to sociodemographic characteristics, workload, time, and problems associated with health, leisure and family members. The costs associated with care were higher in the CM group; however, these differences were not statistically significant.",2020,"The average cost per patient during the monitoring period studied was 13.17% lower in the RM group than in the CM group, and these differences were not statistically significant ( p  = 0.35).","['The average age was 63.14 years (SD = 14.90), 96% of them were women, and the most predominant marital status was married (72', 'patients with pacemakers']","['remote monitoring (RM) and conventional monitoring (CM', 'Informal Care', 'PM under remote monitoring (RM) vs. conventional monitoring (CM', 'informal care immediately after pacemaker (PM) implantation']","['average cost per patient', 'personal characteristics, associated problems, workloads, time, and costs related to informal care', 'sociodemographic characteristics, time, care difficulties, health status, professional aspects, and impact on economic, family, or leisure aspects of the main caregivers providing care']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0024819', 'cui_str': 'Marital status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C3494177', 'cui_str': 'Informal care'}, {'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3494177', 'cui_str': 'Informal care'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]",,0.0284831,"The average cost per patient during the monitoring period studied was 13.17% lower in the RM group than in the CM group, and these differences were not statistically significant ( p  = 0.35).","[{'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Leal-Costa', 'Affiliation': 'Nursing Department, University of Murcia, 30003 Murcia, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Lopez-Villegas', 'Affiliation': 'Social Involvement of Critical and Emergency Medicine, CTS-609 Research Group, Hospital de Poniente, 04700 El Ejido-Almería, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Catalan-Matamoros', 'Affiliation': 'Department of Journalism and Communication, Universidad Carlos III de Madrid, 28903 Madrid, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Robles-Musso', 'Affiliation': 'Intensive Care Unit, Hospital de Poniente, 04700 El Ejido-Almería, Spain.'}, {'ForeName': 'Knut Tore', 'Initials': 'KT', 'LastName': 'Lappegård', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Health Sciences, University of Tromsø, 9019 Tromsø, Norway.'}, {'ForeName': 'Rafael Jesus', 'Initials': 'RJ', 'LastName': 'Bautista-Mesa', 'Affiliation': 'Management Unit, Hospital de Poniente, 04700 El Ejido-Almería, Spain.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Peiró', 'Affiliation': 'Health Services Research Unit, FISABIO-PUBLIC HEALTH, 46020 Valencia, Spain.'}, {'ForeName': 'Remedios', 'Initials': 'R', 'LastName': 'Lopez-Liria', 'Affiliation': 'Department of Nursing Science, Physiotherapy and Medicine, Hum-498 Research Team, Health Research Centre, University of Almería, 04120 El Ejido-Almería, Spain.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare8020175']
2905,32560181,"Effects of L-Phenylalanine on Energy Intake and Glycaemia-Impacts on Appetite Perceptions, Gastrointestinal Hormones and Gastric Emptying in Healthy Males.","In humans, phenylalanine stimulates plasma cholecystokinin (CCK) and pyloric pressures, both of which are important in the regulation of energy intake and gastric emptying. Gastric emptying is a key determinant of postprandial blood glucose. We evaluated the effects of intragastric phenylalanine on appetite perceptions and subsequent energy intake, and the glycaemic response to, and gastric emptying of, a mixed-nutrient drink. The study consisted of two parts, each including 16 healthy, lean males (age: 23 ± 1 years). In each part, participants received on three separate occasions, in randomised, double-blind fashion, 5 g (Phe-5 g) or 10g ('Phe-10 g) L-phenylalanine, or control, intragastrically, 30 min before a standardised buffet-meal (part A), or a standardised mixed-nutrient drink (part B). In part A, plasma CCK and peptide-YY (PYY), and appetite perceptions, were measured at baseline, after phenylalanine alone, and following the buffet-meal, from which energy intake was assessed. In part B, plasma glucose, glucagon-like peptide-1 (GLP-1), insulin and glucagon were measured at baseline, after phenylalanine alone, and for 2 h following the drink. Gastric emptying of the drink was also measured by  13 C-acetate breath-test. Phe-10 g, but not Phe-5 g, stimulated plasma CCK ( p  = 0.01) and suppressed energy intake ( p  = 0.012); energy intake was correlated with stimulation of CCK (r = -0.4,  p  = 0.027), and tended to be associated with stimulation of PYY (r = -0.31,  p  = 0.082). Both Phe-10 g and Phe-5 g stimulated insulin and glucagon (all  p  < 0.05), but not GLP-1. Phe-10 g, but not Phe-5 g, reduced overall plasma glucose ( p  = 0.043) and peak plasma glucose ( p  = 0.017) in response to the mixed-nutrient drink. Phenylalanine had no effect on gastric emptying of the drink. In conclusion, our observations indicate that the energy intake-suppressant effect of phenylalanine is related to the stimulation of CCK and PYY, while the glucoregulatory effect may be independent of stimulation of plasma GLP-1 or slowing of gastric emptying.",2020,"g, but not Phe-5 g, stimulated plasma CCK ( p  = 0.01) and suppressed energy intake ( p  = 0.012)","['16 healthy, lean males (age: 23 ± 1 years', 'Healthy Males']","['Phenylalanine', 'intragastric phenylalanine', 'L-phenylalanine, or control', 'L-Phenylalanine', 'phenylalanine']","['overall plasma glucose', 'appetite perceptions and subsequent energy intake', 'Energy Intake and Glycaemia-Impacts on Appetite Perceptions, Gastrointestinal Hormones and Gastric Emptying', 'plasma CCK and peptide-YY (PYY), and appetite perceptions', 'plasma cholecystokinin (CCK) and pyloric pressures', 'stimulated plasma CCK', 'Gastric emptying', 'peak plasma glucose', 'plasma glucose, glucagon-like peptide-1 (GLP-1), insulin and glucagon', 'suppressed energy intake', 'gastric emptying']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0017182', 'cui_str': 'Gastrointestinal hormone'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0008328', 'cui_str': 'Cholecystokinin'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0034196', 'cui_str': 'Pyloric structure of stomach'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}]",,0.0579056,"g, but not Phe-5 g, stimulated plasma CCK ( p  = 0.01) and suppressed energy intake ( p  = 0.012)","[{'ForeName': 'Penelope C E', 'Initials': 'PCE', 'LastName': 'Fitzgerald', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, Level 5 Adelaide Health and Medical Sciences Building, Corner North Terrace and George Street, Adelaide 5005, Australia.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Manoliu', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, Level 5 Adelaide Health and Medical Sciences Building, Corner North Terrace and George Street, Adelaide 5005, Australia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Herbillon', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, Level 5 Adelaide Health and Medical Sciences Building, Corner North Terrace and George Street, Adelaide 5005, Australia.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Steinert', 'Affiliation': 'Department of Surgery, Division of Visceral and Transplantation Surgery, University Hospital Zürich, 8091 Zürich, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, Level 5 Adelaide Health and Medical Sciences Building, Corner North Terrace and George Street, Adelaide 5005, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Feinle-Bisset', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, Level 5 Adelaide Health and Medical Sciences Building, Corner North Terrace and George Street, Adelaide 5005, Australia.'}]",Nutrients,['10.3390/nu12061788']
2906,32560256,Gait Event Detection for Stroke Patients during Robot-Assisted Gait Training.,"Functional electrical stimulation and robot-assisted gait training are techniques which are used in a clinical routine to enhance the rehabilitation process of stroke patients. By combining these technologies, therapy effects could be further improved and the rehabilitation process can be supported. In order to combine these technologies, a novel algorithm was developed, which aims to extract gait events based on movement data recorded with inertial measurement units. In perspective, the extracted gait events can be used to trigger functional electrical stimulation during robot-assisted gait training. This approach offers the possibility of equipping a broad range of potential robot-assisted gait trainers with functional electrical stimulation. In particular, the aim of this study was to test the robustness of the previously developed algorithm in a clinical setting with patients who suffered a stroke. A total amount of N = 10 stroke patients participated in the study, with written consent. The patients were assigned to two different robot-assisted gait trainers (Lyra and Lokomat) according to their performance level, resulting in five recording sessions for each gait-trainer. A previously developed algorithm was applied and further optimized in order to extract the gait events. A mean detection rate across all patients of 95.8% ± 7.5% for the Lyra and 98.7% ± 2.6% for the Lokomat was achieved. The mean type 1 error across all patients was 1.0% ± 2.0% for the Lyra and 0.9% ± 2.3% for the Lokomat. As a result, the developed algorithm was robust against patient specific movements, and provided promising results for the further development of a technique that can detect gait events during robot-assisted gait training, with the future aim to trigger functional electrical stimulation.",2020,This approach offers the possibility of equipping a broad range of potential robot-assisted gait trainers with functional electrical stimulation.,"['A total amount of N = 10 stroke patients participated in the study, with written consent', 'stroke patients', 'Stroke Patients during Robot-Assisted Gait Training', 'patients who suffered a stroke']","['robot-assisted gait trainers (Lyra and Lokomat', 'Functional electrical stimulation and robot-assisted gait training']",['mean detection rate'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0228287', 'cui_str': 'Structure of hippocampal commissure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",10.0,0.0230811,This approach offers the possibility of equipping a broad range of potential robot-assisted gait trainers with functional electrical stimulation.,"[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schicketmueller', 'Affiliation': 'HASOMED GmbH, Paul-Ecke-Str. 1, 39114 Magdeburg, Germany.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Lamprecht', 'Affiliation': 'MEDIAN Neurological Rehabilitation Center Magdeburg, Gustav-Ricker-Str. 4, 39120 Magdeburg, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Hofmann', 'Affiliation': 'HASOMED GmbH, Paul-Ecke-Str. 1, 39114 Magdeburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sailer', 'Affiliation': 'MEDIAN Neurological Rehabilitation Center Magdeburg, Gustav-Ricker-Str. 4, 39120 Magdeburg, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Rose', 'Affiliation': 'Institute for Medical Engineering and Research Campus STIMULATE, University of Magdeburg, Universitaetsplatz 2, 39106 Magdeburg, Germany.'}]","Sensors (Basel, Switzerland)",['10.3390/s20123399']
2907,32560436,"The Impact of Protein Supplementation on Exercise-Induced Muscle Damage, Soreness and Fatigue Following Prolonged Walking Exercise in Vital Older Adults: A Randomized Double-Blind Placebo-Controlled Trial.","BACKGROUND


It is unknown whether protein supplementation can enhance recovery of exercise-induced muscle damage in older adults who have a disturbed muscle protein synthetic response. We assessed whether protein supplementation could attenuate exercise-induced muscle damage and soreness after prolonged moderate-intensity walking exercise in older adults.
METHODS


In a double-blind, placebo-controlled intervention study, 104 subjects (81% male, ≥65 years) used either a protein (n = 50) or placebo supplement (n = 54) during breakfast and directly after exercise. Within a walking event, study subjects walked 30/40/50 km per day on three consecutive days. Muscle soreness and fatigue were determined with a numeric rating scale, and creatine kinase (CK) concentrations and serum inflammation markers were obtained.
RESULTS


Habitual protein intake was comparable between the protein (0.92 ± 0.27 g/kg/d) and placebo group (0.97 ± 0.23 g/kg/d,  p  = 0.31). At baseline, comparable CK concentrations were found between the protein and the placebo group (110 (IQR: 84-160 U/L) and 115 (IQR: 91-186 U/L), respectively,  p  = 0.84). Prolonged walking (protein: 32 ± 9 km/d, placebo: 33 ± 6 km/d) resulted in a cumulative increase of CK in both the protein (∆283 (IQR: 182-662 U/L)) and placebo group (∆456 (IQR: 209-885 U/L)) after three days. CK elevations were not significantly different between groups ( p  = 0.43). Similarly, no differences in inflammation markers, muscle soreness and fatigue were found between groups.
CONCLUSIONS


Protein supplementation does not attenuate exercise-induced muscle damage, muscle soreness or fatigue in older adults performing prolonged moderate-intensity walking exercise.",2020,"CONCLUSIONS


Protein supplementation does not attenuate exercise-induced muscle damage, muscle soreness or fatigue in older adults performing prolonged moderate-intensity walking exercise.","['104 subjects (81% male, ≥65 years) used either a protein (n = 50) or', 'older adults', 'older adults who have a disturbed muscle protein synthetic response', 'Vital Older Adults']","['Protein supplementation', 'Placebo', 'protein supplementation', 'Prolonged Walking Exercise', 'Protein Supplementation', 'placebo supplement', 'placebo']","['CK elevations', 'CK concentrations', 'Muscle soreness and fatigue', 'cumulative increase of CK', 'numeric rating scale, and creatine kinase (CK) concentrations and serum inflammation markers', 'Habitual protein intake', 'Exercise-Induced Muscle Damage, Soreness and Fatigue', 'inflammation markers, muscle soreness and fatigue', 'muscle damage, muscle soreness or fatigue']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038164', 'cui_str': 'Protein A'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0026832', 'cui_str': 'Muscle Protein'}, {'cui': 'C0442732', 'cui_str': 'Vital'}]","[{'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}]",104.0,0.447597,"CONCLUSIONS


Protein supplementation does not attenuate exercise-induced muscle damage, muscle soreness or fatigue in older adults performing prolonged moderate-intensity walking exercise.","[{'ForeName': 'Dominique S M', 'Initials': 'DSM', 'LastName': 'Ten Haaf', 'Affiliation': 'Radboud Institute for Health Sciences, Department of Physiology, Radboud University Medical Center, 6500 HB Nijmegen, The Netherlands.'}, {'ForeName': 'Coen C W G', 'Initials': 'CCWG', 'LastName': 'Bongers', 'Affiliation': 'Radboud Institute for Health Sciences, Department of Physiology, Radboud University Medical Center, 6500 HB Nijmegen, The Netherlands.'}, {'ForeName': 'Hugo G', 'Initials': 'HG', 'LastName': 'Hulshof', 'Affiliation': 'Radboud Institute for Health Sciences, Department of Physiology, Radboud University Medical Center, 6500 HB Nijmegen, The Netherlands.'}, {'ForeName': 'Thijs M H', 'Initials': 'TMH', 'LastName': 'Eijsvogels', 'Affiliation': 'Radboud Institute for Health Sciences, Department of Physiology, Radboud University Medical Center, 6500 HB Nijmegen, The Netherlands.'}, {'ForeName': 'Maria T E', 'Initials': 'MTE', 'LastName': 'Hopman', 'Affiliation': 'Radboud Institute for Health Sciences, Department of Physiology, Radboud University Medical Center, 6500 HB Nijmegen, The Netherlands.'}]",Nutrients,['10.3390/nu12061806']
2908,32560544,Active Breaks: A Pilot and Feasibility Study to Evaluate the Effectiveness of Physical Activity Levels in a School Based Intervention in an Italian Primary School.,"Background:  The school gives access to children, regardless of age, ethnicity, gender and socio-economic class and can be identified as the key environment in which to promote children's physical activity (PA). The guidelines of the European Union recommend accumulating at least 10-min bouts of PA to reach the daily 60 min. Active breaks (ABs) led by teachers inside the classroom represent a good strategy to promote PA. The aim of this pilot and feasibility study was to evaluate the feasibility and effectiveness in terms of PA level of an AB programme in children aged 8-9 years attending primary school.  Methods:  A pre-post quasi-experimental pilot and feasibility study was performed in two primary school classes, one of which was assigned to a 14-week AB intervention (AB group) and the other to the control group (CG). At baseline and at follow-up, children were monitored for sedentary and motor activity during an entire week using ActiGraph Accelerometer (ActiLife6 wGT3X-BT). The satisfaction of children and teachers was assessed by self-administered questionnaires.  Results:  In the pre-post comparison, AB group ( n  = 16) showed a reduction in the minutes spent in weekly sedentary activity (-168.7 min,  p  > 0.05), an increase in the number of step counts (+14,026.9,  p  < 0.05) and in time spent in moderate to vigorous PA (MVPA): weekly MVPA: +64.4 min, daily MVPA: +8.05 min, percentage of MVPA: +0.70%. On the contrary, CG showed a worsening in all variables. ANCOVA analysis, after adjusting for baseline values, showed significant differences between the AB group and CG for time spent in MVPA, percentage of MVPA and step counts. The satisfaction of children and teachers was good. Teachers were able to adapt the AB protocol to the needs of the school curriculum, thus confirming the feasibility of the AB programme.  Conclusions:  This pilot and feasibility study showed the feasibility and effectiveness of the AB protocol and represented the basis for a future controlled trial.",2020,"p  < 0.05) and in time spent in moderate to vigorous PA (MVPA): weekly MVPA: +64.4 min, daily MVPA: +8.05 min, percentage of MVPA: +0.70%.","['children aged 8-9 years attending primary school', 'Italian Primary School']",['AB programme'],"['number of step counts', 'minutes spent in weekly sedentary activity', 'Physical Activity Levels', 'feasibility and effectiveness']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0557296', 'cui_str': 'Attending primary school'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",2.0,0.0270913,"p  < 0.05) and in time spent in moderate to vigorous PA (MVPA): weekly MVPA: +64.4 min, daily MVPA: +8.05 min, percentage of MVPA: +0.70%.","[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Masini', 'Affiliation': 'Department of Biomedical and Neuromotor Science, University of Bologna, Bologna Via San Giacomo, 12, 40126 Bologna, Italy.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Marini', 'Affiliation': ""Department of Life Quality Studies, University of Bologna, Campus of Rimini, Rimini Corso d'Augusto 237, 47921 Rimini, Italy.""}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Leoni', 'Affiliation': 'Department of Biomedical and Neuromotor Science, University of Bologna, Bologna Via San Giacomo, 12, 40126 Bologna, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Lorusso', 'Affiliation': 'Department of Biomedical and Neuromotor Science, University of Bologna, Bologna Via San Giacomo, 12, 40126 Bologna, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Toselli', 'Affiliation': 'Department of Biomedical and Neuromotor Science, University of Bologna, Bologna Via Selmi, 3, 40126 Bologna, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Tessari', 'Affiliation': 'Department of Psychology, University of Bologna, Bologna Viale Berti Pichat, 5, 40126 Bologna, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ceciliani', 'Affiliation': ""Department of Life Quality Studies, University of Bologna, Campus of Rimini, Rimini Corso d'Augusto 237, 47921 Rimini, Italy.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dallolio', 'Affiliation': 'Department of Biomedical and Neuromotor Science, University of Bologna, Bologna Via San Giacomo, 12, 40126 Bologna, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17124351']
2909,32551827,"An Evaluation of Yoga and Meditation to Improve Attention, Hyperactivity, and Stress in High-School Students.","Objective:  Problems with attention and stress are common in children and predict academic difficulties and other behavioral and emotional problems. Mind-body interventions such as yoga and meditation improve attention and reduce stress. In this study, we examined the impact of Hatha yoga on attention and stress in ninth graders.  Design:  A total of 174 ninth graders from a Texas high school were enrolled in the study. Teachers assigned students to a yoga group (YG) or control group (CG) based on their class schedule. The YG participated in 25-min Hatha yoga classes twice weekly over 12 weeks ( n  = 123). The CG included 51 students. Student self-reports on measures of inattention and hyperactivity (the strengths and weaknesses of ADHD [attention-deficit/hyperactivity disorder] symptoms and normal behavior rating scale for ADHD) and stress (perceived stress scale) were obtained at baseline and at 12 weeks.  Results:  There were no significant differences in baseline levels of inattention ( p  = 0.86), hyperactivity ( p  = 0.25), and perceived stress ( p  = 0.28) between the YG and CG. Regarding inattention scores, there was a significant interaction of group and time ( b  = -1.09, standard error [SE] = 0.30,  p  < 0.001). Pairwise  t -tests showed a significant reduction in inattention for the YG ( d  = 0.27) but a significant increase in inattention for the CG. Regarding hyperactivity, there was no significant interaction of group and time ( b  = -0.43, SE = 0.26,  p  = 0.1). Pairwise  t -tests demonstrated a significant reduction in hyperactivity for the YG ( d  = 0.22), but not the CG. The interaction of group and time was not significant in predicting the slope of change in perceived distress ( b  = -0.93, SE = 1.19,  p  = 0.43). Pairwise  t -tests did not show a significant reduction in perceived distress for either group.  Conclusion:  These findings suggest that Hatha yoga may improve attention and hyperactivity in high school students.",2020,t -tests showed a significant reduction in inattention for the YG ( d  = 0.27) but a significant increase in inattention for the CG.,"['High-School Students', 'high school students', 'ninth graders', 'A total of 174 ninth graders from a Texas high school were enrolled in the study']","['Hatha yoga', 'Yoga and Meditation', 'yoga group (YG) or control group (CG) based on their class schedule']","['Attention, Hyperactivity, and Stress', 'hyperactivity', 'attention and hyperactivity', 'inattention', 'perceived distress', 'inattention and hyperactivity (the strengths and weaknesses of ADHD [attention-deficit/hyperactivity disorder] symptoms and normal behavior rating scale for ADHD) and stress (perceived stress scale', 'slope of change in perceived distress', 'baseline levels of inattention']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205443', 'cui_str': 'Ninth'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0424101', 'cui_str': 'Inattention'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0233512', 'cui_str': 'Normal behavior'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",174.0,0.0385015,t -tests showed a significant reduction in inattention for the YG ( d  = 0.27) but a significant increase in inattention for the CG.,"[{'ForeName': 'Kirti', 'Initials': 'K', 'LastName': 'Saxena', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Verrico', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Saxena', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Sherin', 'Initials': 'S', 'LastName': 'Kurian', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Alexander', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Ramandeep Singh', 'Initials': 'RS', 'LastName': 'Kahlon', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Ruchir P', 'Initials': 'RP', 'LastName': 'Arvind', 'Affiliation': 'Department of Psychiatry, University of Texas Health-McGovern Medical School, Houston, TX, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Goldberg', 'Affiliation': 'Department of Psychiatry, University of Texas Health-McGovern Medical School, Houston, TX, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'DeVito', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Mirza', 'Initials': 'M', 'LastName': 'Baig', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Grieb', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Jafar', 'Initials': 'J', 'LastName': 'Bakhshaie', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Simonetti', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Storch', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Laurel', 'Initials': 'L', 'LastName': 'Williams', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Lex', 'Initials': 'L', 'LastName': 'Gillan', 'Affiliation': 'Institute for Spirituality and Health, Houston, TX, USA.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2020.0126']
2910,32551828,Using Salivary Cortisol as an Objective Measure of Physiological Stress in People With Dementia and Chronic Pain: A Pilot Feasibility Study.,"BACKGROUND


Pain can elevate stress in people with dementia. Although salivary cortisol is used as a biomarker of stress in people with dementia, few studies have reported the feasibility of collection methods to assess salivary cortisol in nursing home residents with both dementia and chronic pain.
OBJECTIVE


To explore the feasibility of collecting cortisol via salivary swab as an indicator of stress in people with dementia and chronic pain.
METHODS


Participants ( N  = 43) aged ≥ 65 years and living with dementia and chronic pain were randomly assigned to the PARO (individual, nonfacilitated, 30-min sessions with the robotic seal PARO, 5 days per week for 6 weeks) or usual-care group using computer-generated random numbers. Salivary cortisol was collected in the early morning before the intervention (Week 0) and at the completion of the intervention (Week 6) for comparison.
RESULTS


There were multiple challenges associated with saliva collection and analysis, including cognitive impairment of participants, ability to obtain repeated samples with saliva volume adequate for assay, and overall cost. Ultimately, adequate saliva was collected from only 8 participants (both pre- and post-intervention) for assay and quantitative analysis.
CONCLUSION


Considering the multiple challenges involved in obtaining valid saliva samples in this population, salivary cortisol may not be a feasible biomarker of physiological stress in people with dementia and chronic pain.",2020,"Ultimately, adequate saliva was collected from only 8 participants (both pre- and post-intervention) for assay and quantitative analysis.
","['nursing home residents with both dementia and chronic pain', 'Participants ( N  = 43) aged ≥ 65 years and living with dementia and chronic pain', 'people with dementia and chronic pain', 'people with dementia', 'People With Dementia and Chronic Pain']","['PARO (individual, nonfacilitated, 30-min sessions with the robotic seal PARO, 5 days per week for 6 weeks) or usual-care group using computer-generated random numbers', 'collecting cortisol via salivary swab']",['Salivary cortisol'],"[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0677547', 'cui_str': 'days/week'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0183753', 'cui_str': 'Swab'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}]",,0.123075,"Ultimately, adequate saliva was collected from only 8 participants (both pre- and post-intervention) for assay and quantitative analysis.
","[{'ForeName': 'Lihui', 'Initials': 'L', 'LastName': 'Pu', 'Affiliation': 'School of Nursing and Midwifery, Griffith University, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Todorovic', 'Affiliation': 'School of Nursing and Midwifery, Griffith University, Australia.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Moyle', 'Affiliation': 'School of Nursing and Midwifery, Griffith University, Australia.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Australia.'}]",Biological research for nursing,['10.1177/1099800420934543']
2911,32551835,Haemodynamics and vasopressor support during prolonged targeted temperature management for 48 hours after out-of-hospital cardiac arrest: a post hoc substudy of a randomised clinical trial.,"BACKGROUND


Comatose patients admitted after out-of-hospital cardiac arrest frequently experience haemodynamic instability and anoxic brain injury. Targeted temperature management is used for neuroprotection; however, targeted temperature management also affects patients' haemodynamic status. This study assessed the haemodynamic status of out-of-hospital cardiac arrest survivors during prolonged (48 hours) targeted temperature management at 33°C.
METHODS


Analysis of haemodynamic and vasopressor data from 311 patients included in a randomised, clinical trial conducted in 10 European hospitals (the TTH48 trial). Patients were randomly allocated to targeted temperature management at 33°C for 24 (TTM24) or 48 (TTM48) hours. Vasopressor and haemodynamic data were reported hourly for 72 hours after admission. Vasopressor load was calculated as norepinephrine (µg/kg/min) plus dopamine(µg/kg/min/100) plus epinephrine (µg/kg/min).
RESULTS


After 24 hours, mean arterial pressure (mean±SD) was 74±9 versus 75±9 mmHg ( P =0.19), heart rate was 57±16 and 55±14 beats/min ( P =0.18), vasopressor load was 0.06 (0.03-0.15) versus 0.08 (0.03-0.15) µg/kg/min ( P =0.22) for the TTM24 and TTM48 groups, respectively. From 24 to 48 hours, there was no difference in mean arterial pressure ( P group =0.32) or lactate ( P group =0.20), while heart rate was significantly lower (average difference 5 (95% confidence interval 2-8) beats/min,  P group <0.0001) and vasopressor load was significantly higher in the TTM48 group ( P group =0.005). In a univariate Cox regression model, high vasopressor load was associated with mortality in univariate analysis (hazard ratio 1.59 (1.05-2.42)  P =0.03), but not in multivariate analysis (hazard ratio 0.77 (0.46-1.29)  P =0.33).
CONCLUSIONS


In this study, prolonged targeted temperature management at 33°C for 48 hours was associated with higher vasopressor requirement but no sign of any detrimental haemodynamic effects.",2020,"From 24 to 48 hours, there was no difference in mean arterial pressure ( P group =0.32) or lactate ( P group =0.20), while heart rate was significantly lower (average difference 5 (95% confidence interval 2-8) beats/min,  P group <0.0001) and vasopressor load was significantly higher in the TTM48 group ( P group =0.005).","['48 hours after out-of-hospital cardiac arrest', '311 patients included in a randomised, clinical trial conducted in 10 European hospitals (the TTH48 trial', 'Comatose patients admitted after out-of-hospital cardiac arrest frequently experience haemodynamic instability and anoxic brain injury', 'out-of-hospital cardiac arrest survivors during prolonged (48 hours) targeted temperature management at 33°C']","['TTM48', 'norepinephrine', 'epinephrine']","['Vasopressor and haemodynamic data', 'vasopressor load', 'Vasopressor load', 'heart rate', 'mean arterial pressure', 'mean arterial pressure (mean±SD']","[{'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0948268', 'cui_str': 'Hemodynamic instability'}, {'cui': 'C0003132', 'cui_str': 'Anoxic encephalopathy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0020674', 'cui_str': 'Induction of hypothermia'}]","[{'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",311.0,0.222496,"From 24 to 48 hours, there was no difference in mean arterial pressure ( P group =0.32) or lactate ( P group =0.20), while heart rate was significantly lower (average difference 5 (95% confidence interval 2-8) beats/min,  P group <0.0001) and vasopressor load was significantly higher in the TTM48 group ( P group =0.005).","[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Grand', 'Affiliation': 'Department of Cardiology, Rigshospitalet - Copenhagen University Hospital, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hassager', 'Affiliation': 'Department of Cardiology, Rigshospitalet - Copenhagen University Hospital, Denmark.'}, {'ForeName': 'Markus B', 'Initials': 'MB', 'LastName': 'Skrifvars', 'Affiliation': 'Department of Anesthesia and Intensive Care, Helsinki University Hospital and University of Helsinki, Finland.'}, {'ForeName': 'Marjaana', 'Initials': 'M', 'LastName': 'Tiainen', 'Affiliation': 'Department of Anesthesia and Intensive Care, Helsinki University Hospital and University of Helsinki, Finland.'}, {'ForeName': 'Anders M', 'Initials': 'AM', 'LastName': 'Grejs', 'Affiliation': 'Department of Intensive Care Medicine, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Anni Nørgaard', 'Initials': 'AN', 'LastName': 'Jeppesen', 'Affiliation': 'Department of Intensive Care Medicine, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Christophe Henri Valdemar', 'Initials': 'CHV', 'LastName': 'Duez', 'Affiliation': 'Research Center for Emergency Medicine, Aarhus University Hospital and Aarhus University, Denmark.'}, {'ForeName': 'Bodil S', 'Initials': 'BS', 'LastName': 'Rasmussen', 'Affiliation': 'Anaesthesiology and Intensive Care, Aalborg University Hospital, Denmark.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Laitio', 'Affiliation': 'Division of Perioperative Services, Intensive Care Medicine and Pain Management, Turku University Hospital, Finland.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Nee', 'Affiliation': 'Department of Intensive Care Medicine, Charité - Universitaetsmedizin Berlin, Germany.'}, {'ForeName': 'FabioSilvio', 'Initials': 'F', 'LastName': 'Taccone', 'Affiliation': 'Department of Intensive Care, Erasme Hospital (ULB), Belgium.'}, {'ForeName': 'Eldar', 'Initials': 'E', 'LastName': 'Søreide', 'Affiliation': 'Critical Care and Anesthesiology Research Group, Stavanger University Hospital, Norway.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Kirkegaard', 'Affiliation': 'Research Center for Emergency Medicine, Aarhus University Hospital and Aarhus University, Denmark.'}]",European heart journal. Acute cardiovascular care,['10.1177/2048872620934305']
2912,32551853,S-1 Maintenance Therapy in Extensive Stage Small-Cell Lung Cancer-A Randomized Clinical Study.,"Small-cell lung cancer (SCLC) is a recalcitrant cancer for its dismal prognosis although extensive research had been done. Four to 6 cycles platinum-based chemotherapy is the mainstay treatment for the extensive-stage disease; but the role of maintenance treatment is not fully understood. This is a phase 2, open-label study. Patients with extensive-stage SCLC reaching an objective response or stable disease (SD) after induction chemotherapy were randomly assigned (1:1) with a minimization procedure. One group received oral S-1 and the other group received placebo as maintenance treatment until disease progression or unacceptable toxicities. The primary end point of this study was progression-free survival (PFS), and the secondary end points were overall survival (OS), response rates, and toxicities. This study was based on earlier work, the preliminary results was reported on 2019 ASCO annual meeting. A total of 89 patients were enrolled, of whom 45 received S-1 maintenance therapy and 44 received placebo. The median PFS and OS were 6.35 months and 10.82 months in the S-1 group, as compared to 5.98 months and 10.09 months in the placebo group. The PFS was 7.2 months and 5.3 months, and OS was 12.9 months and 10.9 months in patients with an objective response compared to in patients with SD after induction chemotherapy, respectively. S-1 maintenance therapy did not prolong PFS or OS in patients with extensive-stage SCLC; tumor regression rate was the prognostic factor of PFS or OS. Further research with novel agents in the maintenance setting is warranted.",2020,maintenance therapy did not prolong PFS or OS in patients with extensive-stage SCLC; tumor regression rate was the prognostic factor of PFS or OS.,"['Patients with extensive-stage SCLC reaching an objective response or stable disease (SD) after induction chemotherapy', '89 patients were enrolled, of whom 45 received', 'patients with extensive-stage SCLC', 'Extensive Stage Small-Cell Lung Cancer']","['S-1 maintenance therapy', 'S-1 Maintenance Therapy', 'S-1', 'oral S-1', 'platinum-based chemotherapy', 'placebo']","['progression-free survival (PFS', 'PFS or OS', 'overall survival (OS), response rates, and toxicities', 'median PFS and OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278726', 'cui_str': 'Small cell lung cancer extensive stage'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}]","[{'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",89.0,0.074097,maintenance therapy did not prolong PFS or OS in patients with extensive-stage SCLC; tumor regression rate was the prognostic factor of PFS or OS.,"[{'ForeName': 'Keke', 'Initials': 'K', 'LastName': 'Nie', 'Affiliation': 'Department of Oncology, Qingdao Central Hospital, Qingdao University, China.'}, {'ForeName': 'Xiuhui', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': ""Pingdu People's Hospital, Qingdao, China.""}, {'ForeName': 'Yunhong', 'Initials': 'Y', 'LastName': 'You', 'Affiliation': 'Department of Oncology, Qingdao Central Hospital, Qingdao University, China.'}, {'ForeName': 'Xingjun', 'Initials': 'X', 'LastName': 'Zhuang', 'Affiliation': 'Department of Oncology, PLA 971 Hospital, Qingdao City, China.'}, {'ForeName': 'Chunling', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, Qingdao Central Hospital, Qingdao University, China.'}, {'ForeName': 'Youxin', 'Initials': 'Y', 'LastName': 'Ji', 'Affiliation': 'Department of Oncology, Qingdao Central Hospital, Qingdao University, China.'}]",Cancer control : journal of the Moffitt Cancer Center,['10.1177/1073274820932004']
2913,32551868,"Maximum Bridging Suture Tension Provides Better Clinical Outcomes in Transosseous-Equivalent Rotator Cuff Repair: A Clinical, Prospective Randomized Comparative Study.","BACKGROUND


Some studies reporting clinical outcomes after transosseous-equivalent (TOE) repair have attributed type II rotator cuff failure to excessive bridging suture tension, as it can cause overloading on the medial row. In a previous biomechanical cadaveric study, increasing bridging suture tension over 90 N did not improve the contact area and ultimate failure load of the TOE construct, despite increasing the contact force and contact pressure.
PURPOSE


To compare the clinical outcomes of different bridging suture tensions after TOE rotator cuff repair based on the results of a previous biomechanical study.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 2.
METHODS


A total of 78 patients who underwent arthroscopic rotator cuff repair for medium- to large-sized tears were prospectively enrolled and randomly divided into 2 groups according to the applied bridging suture tension: optimum tension group (96.3 ± 4.9 N) and maximum tension group (199.0 ± 20.3 N). Bridging suture tension was measured with a customized tensiometer, as used in the previous biomechanical study. The functional outcome was measured at the final follow-up (27.4 ± 5.9 months [range, 24-45 months]) using the visual analog scale for pain, American Shoulder and Elbow Surgeons score, Simple Shoulder Test, and Constant score, and the anatomic outcome was evaluated using magnetic resonance imaging or ultrasonography at least 12 months after surgery.
RESULTS


Overall, 64 patients (32 in each group) were analyzed. The functional outcomes improved significantly compared with preoperative values (all  P  < .05) but did not show significant differences between the 2 groups (all  P  > .05). Regarding the anatomic outcomes, the maximum tension group (n = 1; 3.1%) had a significantly lower healing failure rate than the optimum tension group (n = 9; 28.1%) ( P  = .013). One patient in the maximum tension group had a type II failure.
CONCLUSION


Maximum bridging suture tension in TOE repair for medium- to large-sized rotator cuff tears provided better anatomic healing with less risk of medial rotator cuff failure, which differs from the results of a previous time-zero biomechanical study.",2020,The functional outcomes improved significantly compared with preoperative values (all  P  < .05) but did not show significant differences between the 2 groups (all  P  > .05).,"['Transosseous-Equivalent Rotator Cuff Repair', '78 patients who underwent arthroscopic rotator cuff repair for medium- to large-sized tears', '64 patients (32 in each group) were analyzed']","['Maximum Bridging Suture Tension', 'Maximum bridging suture tension in TOE repair for medium- to large-sized rotator cuff tears', 'bridging suture tension: optimum tension group (96.3 ± 4.9 N) and maximum tension', 'bridging suture tensions after TOE rotator cuff repair', 'transosseous-equivalent (TOE) repair']","['visual analog scale for pain, American Shoulder and Elbow Surgeons score, Simple Shoulder Test, and Constant score, and the anatomic outcome', 'healing failure rate', 'type II failure']","[{'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0263912', 'cui_str': 'Rotator cuff syndrome'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]",78.0,0.0432952,The functional outcomes improved significantly compared with preoperative values (all  P  < .05) but did not show significant differences between the 2 groups (all  P  > .05).,"[{'ForeName': 'Joo Han', 'Initials': 'JH', 'LastName': 'Oh', 'Affiliation': 'Department of Orthopedic Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea.'}, {'ForeName': 'Ji Soon', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Healthpoint, Abu Dhabi, United Arab Emirates.'}, {'ForeName': 'Sung-Min', 'Initials': 'SM', 'LastName': 'Rhee', 'Affiliation': 'Shoulder and Elbow Clinic, Department of Orthopedic Surgery, College of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Joo Hyun', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Orthopedic Surgery, Bundang Jesaeng General Hospital, Daejin Medical Center, Seongnam, Republic of Korea.'}]",The American journal of sports medicine,['10.1177/0363546520930425']
2914,32345594,Patients with Cancer Appear More Vulnerable to SARS-CoV-2: A Multicenter Study during the COVID-19 Outbreak.,"The novel COVID-19 outbreak has affected more than 200 countries and territories as of March 2020. Given that patients with cancer are generally more vulnerable to infections, systematic analysis of diverse cohorts of patients with cancer affected by COVID-19 is needed. We performed a multicenter study including 105 patients with cancer and 536 age-matched noncancer patients confirmed with COVID-19. Our results showed COVID-19 patients with cancer had higher risks in all severe outcomes. Patients with hematologic cancer, lung cancer, or with metastatic cancer (stage IV) had the highest frequency of severe events. Patients with nonmetastatic cancer experienced similar frequencies of severe conditions to those observed in patients without cancer. Patients who received surgery had higher risks of having severe events, whereas patients who underwent only radiotherapy did not demonstrate significant differences in severe events when compared with patients without cancer. These findings indicate that patients with cancer appear more vulnerable to SARS-CoV-2 outbreak. SIGNIFICANCE: Because this is the first large cohort study on this topic, our report will provide much-needed information that will benefit patients with cancer globally. As such, we believe it is extremely important that our study be disseminated widely to alert clinicians and patients. This article is highlighted in the In This Issue feature, p. 747 .",2020,"Patients who received surgery had higher risks of having severe events, whereas patients who underwent only radiotherapy did not demonstrate significant differences in severe events when compared with patients without cancer.","['patients with cancer', 'Patients with nonmetastatic cancer', '105 patients with cancer and 536 age-matched noncancer patients confirmed with COVID-19', 'patients with cancer globally', 'Patients with Cancer Appear More Vulnerable to SARS-CoV-2', 'Patients with hematologic cancer, lung cancer, or with metastatic cancer (stage IV']",['radiotherapy'],"['severe events', 'higher risks of having severe events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}]",105.0,0.0266972,"Patients who received surgery had higher risks of having severe events, whereas patients who underwent only radiotherapy did not demonstrate significant differences in severe events when compared with patients without cancer.","[{'ForeName': 'Mengyuan', 'Initials': 'M', 'LastName': 'Dai', 'Affiliation': 'Department of Gynecological Oncology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Dianbo', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': ""Computational Health Informatics Program, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': ""Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. chb21051@163.com msantill@g.harvard.edu mliu0@bwh.harvard.edu.""}, {'ForeName': 'Fuxiang', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'Hubei Key Laboratory of Tumor Biological Behaviors, Wuhan, China.'}, {'ForeName': 'Guiling', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Cancer Center, Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Emergency, The Central Hospital of Wuhan affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Zhian', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Gynecology, The Central Hospital of Huanggang, Huanggang, Hubei, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'You', 'Affiliation': 'Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Department of Ultrasound, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Qichao', 'Initials': 'Q', 'LastName': 'Zheng', 'Affiliation': 'Department of Ultrasound, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Xiong', 'Affiliation': 'Department of Infectious Disease, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Huihua', 'Initials': 'H', 'LastName': 'Xiong', 'Affiliation': 'Cancer Center, Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, The Central Hospital of Wuhan affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Changchun', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, Hubei Cancer Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xiong', 'Affiliation': 'Department of Thoracic Surgery, Hubei Cancer Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Yaqin', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Department of Obstetrics and Gynecology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Siping', 'Initials': 'S', 'LastName': 'Ge', 'Affiliation': 'Department of Oncology, Wuhan Puren Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Zhen', 'Affiliation': 'Department of Obstetrics and Gynecology, The Central Hospital of Xianning, Xianning, Hubei, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': 'Department of Oncology, The Central Hospital of Xiaogan, Xiaogan, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Department of Obstetrics and Gynecology, The People's Hospital of Huangmei, Huangmei, Hubei, China.""}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of Obstetrics and Gynecology, Xiangyang First People's Hospital affiliated to Hubei University of Medicine, Xiangyang, Hubei, China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Hubei Key Laboratory of Tumor Biological Behaviors, Wuhan, China.'}, {'ForeName': 'Yeshan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Cancer Center, Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Junhua', 'Initials': 'J', 'LastName': 'Mei', 'Affiliation': 'Department of Gynecology, The Central Hospital of Huanggang, Huanggang, Hubei, China.'}, {'ForeName': 'Xiaojia', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Department of Oncology, The Central Hospital of Wuhan affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Zhuyan', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Obstetrics and Gynecology, The People's Hospital of Shiyan, Shiyan, Hubei, China.""}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Gan', 'Affiliation': 'Department of Gynecological Oncology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'He', 'Affiliation': 'Department of Gynecological Oncology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Gynecological Oncology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Yuying', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Gynecological Oncology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Yuwen', 'Initials': 'Y', 'LastName': 'Qi', 'Affiliation': 'Department of Gynecological Oncology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Gynecological Oncology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Daniel G', 'Initials': 'DG', 'LastName': 'Tenen', 'Affiliation': 'Harvard Stem Cell Institute, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chai', 'Affiliation': ""Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Lorelei A', 'Initials': 'LA', 'LastName': 'Mucci', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Dana-Farber, Harvard Cancer Center, Boston, Massachusetts.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Santillana', 'Affiliation': ""Computational Health Informatics Program, Boston Children's Hospital, Boston, Massachusetts. chb21051@163.com msantill@g.harvard.edu mliu0@bwh.harvard.edu.""}, {'ForeName': 'Hongbing', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': 'Department of Gynecological Oncology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China. chb21051@163.com msantill@g.harvard.edu mliu0@bwh.harvard.edu.'}]",Cancer discovery,['10.1158/2159-8290.CD-20-0422']
2915,32386275,Mass Spectrometry-Based Analysis of Urinary Biomarkers for Dietary Tomato Intake.,"SCOPE


In this study, the applicability of several β-carboline, imidazole, and steroidal alkaloids as biomarkers for tomato juice intake is evaluated.
METHODS AND RESULTS


Over the course of a 2-week crossover dietary intervention study, 14 volunteers were given low and high doses of tomato juice after 3 days of avoiding tomato-based products. On the day of consumption and the following days, volunteers provided urine samples that were quantitatively analyzed by high-performance liquid chromatography-tandem mass spectrometry. Herein, glucose-derived β-carboline alkaloids are determined as supporting, yet non-specific dietary biomarkers for tomato juice intake. Several imidazole alkaloids represent further biomarkers, which are shown to specifically indicate consumption of tomato juice for 24 h and partly >24 h. Additionally, steroidal alkaloids derived from esculeogenin B are determined to be specific biomarkers for tomato juice detectable for at least 48 h after consumption. The intake of low and high amounts of tomato juice is significantly distinguishable based on the urinary excretion of all determined biomarkers as well.
CONCLUSIONS


The dietary intake of tomato juice is conclusively traceable based on urinary excretion of multiple β-carboline, imidazole, and steroidal alkaloids, and can be determined for up to 48 h after consumption. Furthermore, different intake doses can clearly be distinguished based on their urinary excretion.",2020,"The intake of low and high amounts of tomato juice is significantly distinguishable based on the urinary excretion of all determined biomarkers as well.
",['14 volunteers'],"['β-carboline, imidazole, and steroidal alkaloids']",[],"[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0007007', 'cui_str': 'Pyrido(4,3-b)Indoles'}, {'cui': 'C0020923', 'cui_str': 'Imidazole'}, {'cui': 'C0002062', 'cui_str': 'Alkaloid'}]",[],14.0,0.0188236,"The intake of low and high amounts of tomato juice is significantly distinguishable based on the urinary excretion of all determined biomarkers as well.
","[{'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Hövelmann', 'Affiliation': 'Institute of Food Chemistry, Westfälische Wilhelms-Universität, Münster, 48149, Germany.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Lewin', 'Affiliation': 'Institute of Food Chemistry, Westfälische Wilhelms-Universität, Münster, 48149, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Steinert', 'Affiliation': 'Institute of Food Chemistry, Westfälische Wilhelms-Universität, Münster, 48149, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Hübner', 'Affiliation': 'Institute of Food Chemistry, Westfälische Wilhelms-Universität, Münster, 48149, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Humpf', 'Affiliation': 'Institute of Food Chemistry, Westfälische Wilhelms-Universität, Münster, 48149, Germany.'}]",Molecular nutrition & food research,['10.1002/mnfr.202000011']
2916,32389143,Efficacy and Acceptance of a Lombard-response Device for Hypophonia in Parkinson's Disease.,"OBJECTIVE


The purpose of this study was to examine the effectiveness, satisfaction, and acceptance of a low-cost Lombard-response (LR) device in a group of individuals with Parkinson's disease (IWPD) and their communication partners (CPs).
METHOD


Sixteen IWPD and hypophonia and their CPs participated in the study. The IWPD wore a LR device that included a small MP3 player (Sony Walkman) and headphones playing a multi-talker noise audio file at 80 dB during lab-based speech tasks and during their daily conversational speech over a 2-week device trial period. Outcome measures included average conversational speech intensity and scores on a questionnaire related to speech impairment, communication effectiveness, and device satisfaction.
RESULTS


Conversational speech intensity of the IWPD is increased by 7 to 10 dB with the LR device. Following a 2-week trial period, eight of the IWPD (50%) gave the LR device moderate-to-high satisfaction and effectiveness ratings and decided to purchase the device for long-term daily use. At the 4-month follow-up, none of the IWPDs were still using the LR device. Device rejection was related to discomfort (loudness), headaches, interference with cognition, and difficulty controlling device.
CONCLUSION


Short-term acceptance and satisfaction with the LR device was moderate, but long-term acceptance, beyond 4 months, was absent. Future studies are required to determine if other types of low-cost LR devices can be developed that improve long-term efficacy and device acceptance in IWPD and hypophonia.",2020,"Outcome measures included average conversational speech intensity and scores on a questionnaire related to speech impairment, communication effectiveness, and device satisfaction.
","[""Hypophonia in Parkinson's Disease"", ""individuals with Parkinson's disease (IWPD) and their communication partners (CPs"", 'Sixteen IWPD and hypophonia and their CPs participated in the study']",['Lombard-response Device'],"['effectiveness, satisfaction, and acceptance of a low-cost Lombard-response (LR) device', 'average conversational speech intensity and scores on a questionnaire related to speech impairment, communication effectiveness, and device satisfaction', 'Device rejection', 'discomfort (loudness), headaches, interference with cognition, and difficulty controlling device', 'Efficacy and Acceptance']","[{'cui': 'C0521007', 'cui_str': 'Hypophonia'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0037822', 'cui_str': 'Speech disorder'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C3160823', 'cui_str': 'Device rejection'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0359591,"Outcome measures included average conversational speech intensity and scores on a questionnaire related to speech impairment, communication effectiveness, and device satisfaction.
","[{'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Adams', 'Affiliation': 'Department of Clinical Neurological Sciences, Western University, London, Ontario, Canada.'}, {'ForeName': 'Niraj', 'Initials': 'N', 'LastName': 'Kumar', 'Affiliation': 'Department of Clinical Neurological Sciences, Western University, London, Ontario, Canada.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Rizek', 'Affiliation': 'Department of Clinical Neurological Sciences, Western University, London, Ontario, Canada.'}, {'ForeName': 'Angeline', 'Initials': 'A', 'LastName': 'Hong', 'Affiliation': 'Department of Clinical Neurological Sciences, Western University, London, Ontario, Canada.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Clinical Neurological Sciences, Western University, London, Ontario, Canada.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Senthinathan', 'Affiliation': 'School of Communication Sciences and Disorders, Western University, London, Ontario, Canada.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Mancinelli', 'Affiliation': 'School of Communication Sciences and Disorders, Western University, London, Ontario, Canada.'}, {'ForeName': 'Thea', 'Initials': 'T', 'LastName': 'Knowles', 'Affiliation': 'School of Communication Sciences and Disorders, Western University, London, Ontario, Canada.'}, {'ForeName': 'Mandar', 'Initials': 'M', 'LastName': 'Jog', 'Affiliation': 'Department of Clinical Neurological Sciences, Western University, London, Ontario, Canada.'}]",The Canadian journal of neurological sciences. Le journal canadien des sciences neurologiques,['10.1017/cjn.2020.90']
2917,32553878,Impact of Platelet rich plasma in the healing of through-and-through periapical lesions using 2-D and 3-D evaluation: A randomized controlled trial.,"INTRODUCTION


The purpose of this randomized controlled trial was to evaluate the role of platelet rich plasma (PRP) in the healing of through-and-through periapical lesions using both 2-dimensional (2D) periapical radiograph and 3-dimensional (3D) cone beam computed tomography (CBCT).
METHODS


34 patients after confirmation of through-and-through periapical lesion were enrolled and randomly assigned to either the control or PRP group. Periapical surgery was performed and grafting of the bone defect with PRP was done in the PRP group prior to suturing and follow up was scheduled at 12 months for clinical and radiographic analysis based on Molven's criteria, modified PENN 3D criteria and RAC indices. The absolute area and volume of the lesions were measured preoperatively and at follow up using Corel draw X7(64-bit) and ITK Snap software respectively.
RESULTS


32 patients were available at follow up. A success rate of 93.7% was observed for both the control and PRP group on 2D evaluation while the PRP group exhibited a significantly higher success rate (87.5%) than the control (50%) on 3D assessment. A significantly higher percentage reduction in the lesion volume was documented in the PRP (92.30±4.72) group than the control (83.04±12.82). RAC indices revealed a significantly higher scoring at resected plane and cortical plate parameter in the PRP group. Overall analysis documented the faster reestablishment of palatal cortical plate than buccal cortical plate in through-and-through lesions.
CONCLUSIONS


These results suggests that PRP improves the healing outcome in through-and-through lesions. CBCT provides better healing assessment after periapical surgery over periapical radiographs in such lesions.",2020,A significantly higher percentage reduction in the lesion volume was documented in the PRP (92.30±4.72) group than the control (83.04±12.82).,"['34 patients after confirmation of through-and-through periapical lesion', '32 patients were available at follow up']","['platelet rich plasma (PRP', 'PRP', '2-dimensional (2D) periapical radiograph and 3-dimensional (3D) cone beam computed tomography (CBCT', 'CBCT', 'Platelet rich plasma', 'control or PRP']","['absolute area and volume of the lesions', 'lesion volume', 'success rate', 'healing outcome']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521091', 'cui_str': 'Confirmation of'}, {'cui': 'C0729269', 'cui_str': 'Periapical'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0729269', 'cui_str': 'Periapical'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",32.0,0.0684005,A significantly higher percentage reduction in the lesion volume was documented in the PRP (92.30±4.72) group than the control (83.04±12.82).,"[{'ForeName': 'Ritika', 'Initials': 'R', 'LastName': 'Dhamija', 'Affiliation': ''}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Tewari', 'Affiliation': ''}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Sangwan', 'Affiliation': ''}, {'ForeName': 'Jigyasa', 'Initials': 'J', 'LastName': 'Duhan', 'Affiliation': ''}, {'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': ''}]",Journal of endodontics,['10.1016/j.joen.2020.06.004']
2918,32553996,"The effects of a nurse-led lifestyle intervention program on cardiovascular risk, self-efficacy and health promoting behaviours among patients with metabolic syndrome: Randomized controlled trial.","BACKGROUND


Metabolic syndrome is a cluster of cardio-metabolic risk factors and a major burden for public health due to its increasing prevalence and adverse effects on cardiovascular health. Lifestyle modification is the first-line intervention for metabolic syndrome management. However, adopting healthy behaviours is challenging among patients with metabolic syndrome.
OBJECTIVE


To examine the effects of a nurse-led lifestyle intervention program on cardiovascular risks, self-efficacy and the implementation of health promoting behaviours.
DESIGN


A two-armed randomized controlled trial.
SETTINGS AND PARTICIPANTS


A total of 173 patients that satisfied the metabolic syndrome definition of International Diabetes Federation was recruited from a hospital in North China.
METHODS


The participants were randomly assigned to either attend the lifestyle interventions (n = 86) or receive usual care from the study hospital (n = 87). The lifestyle intervention followed the framework of Health Promotion Model and consisted of one face-to-face education session (30-40 min), one educational booklet and six telephone follow-ups (bi-weekly, 20-30 min per call) in three months. The Framingham 10-year risk score was calculated to measure the participants' cardiovascular risks at baseline and 3-month. The Self-rated Abilities for Health Practices and Health Promoting Lifestyle Profile II was employed to measure the self-efficacy and health promoting behaviours at baseline, 1-month, and 3-month. The generalized estimating equation model was employed to examine the effects of the lifestyle intervention program.
RESULTS


No difference was detected in the baseline characteristics between the two groups. Decreased cardiovascular risk was found in the lifestyle intervention group, but no significant group-by-time effect was detected. The self-efficacy for nutrition, stress dimension and sum score of health promoting behaviours revealed significant improvements at 1-month (all p < 0.05). Significant improvements were also detected in all subscales, total scale of self-efficacy, all dimensions and the sum score of health promoting behaviours at 3-month (all p < 0.05).
CONCLUSIONS


The nurse-led Health Promotion Model guided lifestyle intervention program effectively improved the self-efficacy and implementation of health promoting behaviours in patients with metabolic syndrome. We recommend that nurses apply lifestyle interventions in routine care for patients with metabolic syndrome. Tweetable abstract: The RCT revealed that nurse-led lifestyle intervention was effective to improve self-efficacy and healthy behaviours among 173 MetS patients.",2020,"The self-efficacy for nutrition, stress dimension and sum score of health promoting behaviours revealed significant improvements at 1-month (all p < 0.05).","['173 patients that satisfied the metabolic syndrome definition of International Diabetes Federation was recruited from a hospital in North China', 'patients with metabolic syndrome', '173 MetS patients']","['nurses apply lifestyle interventions', 'nurse-led lifestyle intervention program', 'lifestyle intervention followed the framework of Health Promotion Model and consisted of one face-to-face education session (30-40\xa0min), one educational booklet and six telephone follow-ups', 'lifestyle interventions (n\xa0=\xa086) or receive usual care from the study hospital', 'Tweetable abstract']","['cardiovascular risks, self-efficacy', 'cardiovascular risk', 'cardiovascular risk, self-efficacy and health promoting behaviours', 'subscales, total scale of self-efficacy, all dimensions and the sum score of health promoting behaviours', 'self-efficacy and healthy behaviours', 'Framingham 10-year risk score', 'self-efficacy and implementation of health promoting behaviours', 'self-efficacy for nutrition, stress dimension and sum score of health promoting behaviours']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0000857', 'cui_str': 'Abstracting as Topic'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0517496', 'cui_str': 'Health promotion behavior'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",173.0,0.0272669,"The self-efficacy for nutrition, stress dimension and sum score of health promoting behaviours revealed significant improvements at 1-month (all p < 0.05).","[{'ForeName': 'Xujuan', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'School of Nursing, Shenzhen University, No.1066 Xueyuan Road, Nanshan District, Shenzhen 518055, China. Electronic address: zhengxujuan@szu.edu.cn.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': ""Department of Endocrinology, Pingdu People's Hospital, Qingdao, China. Electronic address: yuhongbo.doc@163.com.""}, {'ForeName': 'Xichenhui', 'Initials': 'X', 'LastName': 'Qiu', 'Affiliation': 'School of Nursing, Shenzhen University, No.1066 Xueyuan Road, Nanshan District, Shenzhen 518055, China. Electronic address: qiuxichenhui@163.com.'}, {'ForeName': 'Sek Ying', 'Initials': 'SY', 'LastName': 'Chair', 'Affiliation': 'The Nethersole School of Nursing, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong. Electronic address: sychair@cuhk.edu.hk.'}, {'ForeName': 'Eliza Mi-Ling', 'Initials': 'EM', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University. Hung Hom, Kowloon, Hong Kong. Electronic address: eliza.wong@polyu.edu.hk.'}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, Shenzhen University, No.1066 Xueyuan Road, Nanshan District, Shenzhen 518055, China. Electronic address: qunwang@szu.edu.cn.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103638']
2919,32554025,swCRTdesign: An R Package for Stepped Wedge Trial Design and Analysis.,"BACKGROUND AND OBJECTIVE


Stepped wedge trials (SWTs) are a type of cluster-randomized trial that are commonly used to evaluate health care interventions. Most SWT-related software packages have restrictive assumptions about the study design and correlation structure of the data. The objective of this paper is to present a package and corresponding web-based graphical user interface (GUI) that provide researchers with another, more flexible option for SWT design and analysis.
METHODS


We developed an R package swCRTdesign ('stepped wedge Cluster Randomized Trial design'), which uses a random effects model to account for correlation in the data induced by a SWT design. Possible sources of correlation include clusters, time within clusters, and treatment within clusters.
RESULTS


swCRTdesign allows a user to calculate power, simulate SWT data to streamline simulation studies (e.g. to estimate power), and create descriptive summaries and plots. Additionally, a GUI, developed using shiny, is available to calculate power and create power curves and design plots.
CONCLUSIONS


The swCRTdesign package accommodates a wide variety of SWT designs, and makes it easy to account for some sources of correlation which are not found in other packages. The user-friendly web-based GUI makes some swCRTdesign features accessible to researchers not familiar with R. These two resources will make appropriately complex SWT calculations more accessible to scientists from a wide variety of backgrounds.",2020,"We developed an R package swCRTdesign ('stepped wedge Cluster Randomized Trial design'), which uses a random effects model to account for correlation in the data induced by a SWT design.",[],['swCRTdesign'],[],[],[],[],,0.150645,"We developed an R package swCRTdesign ('stepped wedge Cluster Randomized Trial design'), which uses a random effects model to account for correlation in the data induced by a SWT design.","[{'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Voldal', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States. Electronic address: voldal@uw.edu.'}, {'ForeName': 'Navneet R', 'Initials': 'NR', 'LastName': 'Hakhu', 'Affiliation': 'Department of Statistics, University of California, Irvine, Irvine, CA 92697, United States.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Xia', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Heagerty', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Hughes', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States.'}]",Computer methods and programs in biomedicine,['10.1016/j.cmpb.2020.105514']
2920,32554035,Effect of a computer network-based feedback program on antibiotic prescription rates of primary care physicians: A cluster randomized crossover-controlled trial.,"OBJECTIVE


Antibiotic overuse is one of the major prescription problems in rural China and a major risk factor for antibiotic resistance. Low antibiotic prescription rates can effectively reduce the risk of antibiotic resistance. We hypothesized that under a paperless, computer-based feedback system the rates of antibiotic prescriptions among primary care physicians can be reduced.
METHODS


A cluster randomized crossover open controlled trial was conducted in 31 hospitals. These hospitals were randomly allocated to two groups to receive the intervention for three months followed by no intervention for three months in a random sequence. The feedback intervention information, which displayed the physicians' antibiotic prescription rates and ranking, was updated every 10 days. The primary outcome was the 10-day antibiotic prescription rate of the physicians.
RESULTS


There were 82 physicians in group 1 (intervention first followed by control) and 81 in group 2 (control first followed by intervention). Baseline comparison showed no significant difference in antibiotic prescription rate between the two groups (30.8% vs 35.2%, P-value=0.07). At the crossover point, the relative reduction in antibiotic prescription rate was significantly higher among physicians in the intervention group than in the control group (33.1% vs 20.3%, P-value<0.001). After a further 3 months, the rate of decline in antibiotic prescriptions was also significantly greater in the intervention group compared to the control group (14.2% vs 4.6%, P-value<0.001). The characteristics of physicians did not significantly determine the change in rate of antibiotic prescriptions.
CONCLUSION


A computer network-based feedback intervention can significantly reduce the antibiotic prescription rates of primary care outpatient physicians and continuously affected their prescription behavior for up to six months.
TRIAL REGISTRATION


ChiCTR1900021823.",2020,"At the crossover point, the relative reduction in antibiotic prescription rate was significantly higher among physicians in the intervention group than in the control group (33.1% vs 20.3%, P-value<0.001).","['31 hospitals', 'primary care physicians']","['computer network-based feedback intervention', 'computer network-based feedback program']","['rate of antibiotic prescriptions', 'antibiotic prescription rates', 'antibiotic prescription rate', 'risk of antibiotic resistance', '10-day antibiotic prescription rate of the physicians', 'rate of decline in antibiotic prescriptions']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0949285', 'cui_str': 'Antibiotic Resistance'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031831', 'cui_str': 'Physician'}]",,0.0905095,"At the crossover point, the relative reduction in antibiotic prescription rate was significantly higher among physicians in the intervention group than in the control group (33.1% vs 20.3%, P-value<0.001).","[{'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Chang', 'Affiliation': 'School of Medicine and Health Management, Guizhou Medical University, Guizhou 550025, China; Epidemiology Unit, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla 90110, Thailand.'}, {'ForeName': 'Rassamee', 'Initials': 'R', 'LastName': 'Sangthong', 'Affiliation': 'Epidemiology Unit, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla 90110, Thailand.'}, {'ForeName': 'Edward B', 'Initials': 'EB', 'LastName': 'McNeil', 'Affiliation': 'Epidemiology Unit, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla 90110, Thailand.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': 'School of Medicine and Health Management, Guizhou Medical University, Guizhou 550025, China. Electronic address: tlei1974@163.com.'}, {'ForeName': 'Virasakdi', 'Initials': 'V', 'LastName': 'Chongsuvivatwong', 'Affiliation': 'Epidemiology Unit, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla 90110, Thailand. Electronic address: cvirasak@medicine.psu.ac.th.'}]",Journal of infection and public health,['10.1016/j.jiph.2020.05.027']
2921,32554067,Dexmedetomidine Provides Fewer Respiratory Events Compared With Propofol and Fentanyl During Third Molar Surgery: A Randomized Clinical Trial.,"PURPOSE


Propofol and fentanyl can cause airway obstruction and respiratory depression when used together for intravenous sedation. This study investigated whether dexmedetomidine and midazolam would decrease respiratory events requiring intervention during deep sedation compared with propofol, fentanyl, and midazolam.
PATIENTS AND METHODS


A prospective, randomized, double-blinded, controlled trial was designed to assess 2 intravenous treatment groups during third molar surgery. Patients were randomized into 2 groups. The control group (group P) received 0.8 μg/kg of fentanyl followed by propofol infusion at 125 μg/kg per minute over a 10-minute period with intraoperative boluses of 0.1 μg/kg. The study group (group D) received dexmedetomidine bolus infusion of 1 μg/kg over a 10-minute period followed by maintenance infusion at 0.5 μg/kg per hour. Both groups were given 0.03 mg/kg of midazolam before infusion. Scorers, masked to group, viewed the procedure remotely and evaluated the primary outcome variable of respiratory events requiring intervention. Secondary outcome variables evaluated by the scorers included the Behavioral Pain Scale for non-intubated patients at initial injection, cooperation score at 5 and 15 minutes, and time to ambulation and discharge. Patient satisfaction and hemodynamic stability were measured. The difference between groups regarding the occurrence of respiratory events was tested using the Fisher exact test, and mixed-effects models were used to compare repeated vital signs.
RESULTS


The sample was composed of 141 patients randomly assigned to either group P (n = 67) or group D (n = 74). No statistically significant differences in the distribution of study variables were found between groups at baseline. A statistically significant difference in respiratory events requiring deliberate intervention existed between group P (25.4%) and group D (2.7%) (P < .0001). No statistically significant difference was found between groups for Behavioral Pain Scale score, cooperation score, time to ambulation or discharge, and patient satisfaction.
CONCLUSIONS


Using dexmedetomidine and midazolam for outpatient surgery resulted in fewer respiratory events requiring deliberate intervention compared with propofol, fentanyl, and midazolam. Ambulation and discharge times were not prolonged using dexmedetomidine.",2020,"No statistically significant difference was found between groups for Behavioral Pain Scale score, cooperation score, time to ambulation or discharge, and patient satisfaction.
",['141 patients randomly assigned to either group P (n\xa0=\xa067) or group D'],"['dexmedetomidine bolus infusion of 1\xa0μg/kg over a 10-minute period followed by maintenance infusion', 'Dexmedetomidine', 'Propofol and Fentanyl', 'Propofol and fentanyl', 'fentanyl followed by propofol infusion', 'propofol, fentanyl, and midazolam', 'dexmedetomidine and midazolam', 'midazolam', 'dexmedetomidine']","['occurrence of respiratory events', 'Respiratory Events', 'respiratory events', 'Patient satisfaction and hemodynamic stability', 'Behavioral Pain Scale score, cooperation score, time to ambulation or discharge, and patient satisfaction', 'Behavioral Pain Scale for non-intubated patients at initial injection, cooperation score at 5 and 15\xa0minutes, and time to ambulation and discharge', 'Ambulation and discharge times']","[{'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0441849', 'cui_str': 'Group P'}, {'cui': 'C0441838', 'cui_str': 'Group D'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C1320717', 'cui_str': 'Respiratory event'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1442447', 'cui_str': 'Fifteen minutes'}]",141.0,0.396816,"No statistically significant difference was found between groups for Behavioral Pain Scale score, cooperation score, time to ambulation or discharge, and patient satisfaction.
","[{'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Nolan', 'Affiliation': 'Assistant Professor, Division of Oral and Maxillofacial Surgery, Department of Dentistry, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, NY. Electronic address: PNOLAN@montefiore.org.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Delgadillo', 'Affiliation': 'Resident, Division of Oral and Maxillofacial Surgery, Department of Dentistry, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Youssef', 'Affiliation': 'Resident, Division of Oral and Maxillofacial Surgery, Department of Dentistry, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Freeman', 'Affiliation': 'Professor of Biomedical Science, Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, FL.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Jones', 'Affiliation': 'Former Resident, Division of Oral and Maxillofacial Surgery, Department of Dentistry, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Arian', 'Initials': 'A', 'LastName': 'Chehrehsa', 'Affiliation': 'Former Resident, Division of Oral and Maxillofacial Surgery, Department of Dentistry, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, NY.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.05.015']
2922,32554068,Does the Low-Intensity Laser Protocol Affect Tissue Healing After Third Molar Removal?,"PURPOSE


Studies have shown that laser therapy is a recommended therapy for improving the postoperative period in patients undergoing extraction of the third molars; however, there is still no definition regarding the best protocol to be used. The aim of this study was to measure and compare periodontal tissue healing using 2 different laser protocols.
MATERIALS AND METHODS


A double-blinded, randomized, prospective study with patients submitted to inferior third molar extraction was performed, with the sample divided into 3 groups according to the laser application protocol and followed up for 6 months: group I, 10 J/cm 2 ; group II, 30 J/cm 2 ; and group III, sham. The primary variable was probing depth, and the secondary variables were trismus, facial edema, and pain.
RESULTS


The sample was composed of 57 patients: 19 in group I, 20 in group II, and 18 in group III. Analysis of the variables showed statistically significant differences between both groups that received laser therapy, with values of 1.46 for edema control on the third day and 0.54 on the seventh day in group I (P = .017) and 1.26 and 0.52, respectively, in group II (P = .001) compared with 0.59 and 0.49, respectively, in the sham group (P = .702), as well as a statistically significant difference for the 10-J/cm 2  laser protocol for probing depth, with values of 7.58 mm preoperatively and 9.09 mm after 6 months (P = .013).
CONCLUSIONS


The use of the low-intensity laser as adjuvant therapy after third molar extraction was more effective in the group undergoing the 10-J/cm 2  laser protocol for improving periodontal tissue healing and in both laser therapy groups for reducing facial edema.",2020,"Analysis of the variables showed statistically significant differences between both groups that received laser therapy, with values of 1.46 for edema control on the third day and 0.54 on the seventh day in group","['patients submitted to inferior third molar extraction', 'patients undergoing extraction of the third molars']","['laser therapy', 'low-intensity laser']","['periodontal tissue healing', 'facial edema', 'trismus, facial edema, and pain', 'Tissue Healing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C3873737', 'cui_str': 'Low-intensity laser'}]","[{'cui': 'C0031104', 'cui_str': 'Structure of gum and supporting structure of tooth'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0542571', 'cui_str': 'Edema of face'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}]",57.0,0.0358131,"Analysis of the variables showed statistically significant differences between both groups that received laser therapy, with values of 1.46 for edema control on the third day and 0.54 on the seventh day in group","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Bianchi de Moraes', 'Affiliation': 'Assistant Professor, Division of Oral and Maxillofacial Surgery, Department of Diagnosis and Surgery, State University of São Paulo (UNESP), College of Dentistry, São José dos Campos, Brazil.'}, {'ForeName': 'Rúbia', 'Initials': 'R', 'LastName': 'Gomes de Oliveira', 'Affiliation': 'MS Student, Oral and Maxillofacial Surgery Area, Department of Diagnosis and Surgery, State University of São Paulo (UNESP), College of Dentistry, São José dos Campos, Brazil.'}, {'ForeName': 'Fernando Vagner', 'Initials': 'FV', 'LastName': 'Raldi', 'Affiliation': 'Assistant Professor, Division of Oral and Maxillofacial Surgery, Department of Diagnosis and Surgery, State University of São Paulo (UNESP), College of Dentistry, São José dos Campos, Brazil.'}, {'ForeName': 'Rodrigo Dias', 'Initials': 'RD', 'LastName': 'Nascimento', 'Affiliation': 'Assistant Professor, Division of Oral and Maxillofacial Surgery, Department of Diagnosis and Surgery, State University of São Paulo (UNESP), College of Dentistry, São José dos Campos, Brazil.'}, {'ForeName': 'Mauro Pedrine', 'Initials': 'MP', 'LastName': 'Santamaria', 'Affiliation': 'Assistant Professor, Division of Periodontics, Department of Diagnosis and Surgery, State University of São Paulo (UNESP), College of Dentistry, São José dos Campos, Brazil.'}, {'ForeName': 'Fábio Ricardo', 'Initials': 'FR', 'LastName': 'Loureiro Sato', 'Affiliation': 'Assistant Professor, Division of Oral and Maxillofacial Surgery, Department of Diagnosis and Surgery, State University of São Paulo (UNESP), College of Dentistry, São José dos Campos, Brazil. Electronic address: fabio.sato@ict.unesp.br.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.05.018']
2923,32560734,"Efficacy and safety of Dingkun pill for female infertility patients with low prognosis undergoing in vitro fertilization-embryo transfer: study protocol for a multicenter, double-blind, randomized, placebo-controlled trial.","BACKGROUND


Approximately 15% of couples in the reproductive age are affected by infertility. Women with diminished ovarian reserves (DOR) or with a poor ovarian response (POR) are required to undergo in vitro fertilization and embryo transfer (IVF-ET) to achieve pregnancy. However, studies indicate that poor response to gonadotropin stimulation has been reported in women undergoing IVF-ET. Results from two recent clinical studies in China suggest that traditional Chinese medicine (TCM) formula Dingkun pill (DKP) showed a curative effect by improving the clinical pregnancy rate in women with DOR and POR. However, the heterogeneity of the studies does not allow one to draw a definitive conclusion on the therapeutic effect of DKP. Therefore, the purpose of this study was to investigate the effect of DKP on improving the clinical outcome of pregnancy of IVF-ET in women with low prognosis.
METHODS


A multicenter, double-blinded, randomized placebo-controlled trial was conducted. A total of 460 infertile patients undergoing IVF or intracytoplasmic sperm injection (ICSI) were recruited from 12 public hospitals in China. Participants were randomly divided into the experimental group (DKP formula) or the placebo group (control) at a ratio of 1:1. All patients were treated with GnRH antagonist protocol and ovarian stimulation performed for 5 weeks (from the 5th day of the previous menstrual cycle to the day of oocyte retrieval). The patients were followed up for 6 months to record their conception outcome. The primary outcome is to compare the pregnancy outcome to those under placebo treatment. Secondary outcomes included the total count of the retrieved oocyte, embryo quality, endometrial thickness on ET day, implantation rate, and early miscarriage rate.
DISCUSSION


Currently, no multicenter, double-blind, randomized, placebo-controlled trials have been performed on the use of the DKP formula to improve on the clinical outcome of the conception of IVF-ET in women with low prognosis. DKP might provide a good clinical solution for females with low prognosis and undergoing IVF. There is no contemporary Western medicine to improve on the clinical outcome of conception in IVF-ET in women with low prognosis. Therefore, it is important to undertake a well-designed randomized trial to determine the effect of DKP in improving the clinical outcome of the conception of IVF-ET in women with low prognosis.
TRIAL REGISTRATION


Chinese Clinical Trial Registry (ChiCTR).
TRIAL REGISTRATION NUMBER


ChiCTR1900026614. Registered on 16 October 2019.",2020,There is no contemporary Western medicine to improve on the clinical outcome of conception in IVF-ET in women with low prognosis.,"['women with low prognosis', 'women undergoing IVF-ET', 'females with low prognosis and undergoing IVF', 'Women with diminished ovarian reserves (DOR) or with a poor ovarian response (POR', 'women with DOR and POR', '460 infertile patients undergoing IVF or intracytoplasmic sperm injection (ICSI) were recruited from 12 public hospitals in China', 'female infertility patients with low prognosis undergoing in vitro fertilization-embryo transfer']","['DKP', 'GnRH antagonist protocol and ovarian stimulation', 'Dingkun pill', 'traditional Chinese medicine (TCM) formula Dingkun pill (DKP', 'placebo']","['pregnancy outcome', 'clinical pregnancy rate', 'Efficacy and safety', 'total count of the retrieved oocyte, embryo quality, endometrial thickness on ET day, implantation rate, and early miscarriage rate']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C3839507', 'cui_str': 'Diminished ovarian reserve'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0021361', 'cui_str': 'Female infertility'}]","[{'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C4324508', 'cui_str': 'Early miscarriage'}]",460.0,0.653768,There is no contemporary Western medicine to improve on the clinical outcome of conception in IVF-ET in women with low prognosis.,"[{'ForeName': 'Jingyan', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'The First Clinical College, Shandong University of Traditional Chinese Medicine, Jinan, 250014, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Ma', 'Affiliation': 'Science and Technology Department, Shandong University of Traditional Chinese Medicine, Jinan, 250300, China.'}, {'ForeName': 'Yanlin', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Medical Marketing Department, Shanxi Guangyuyuan Medicine Co., Ltd., Xian, 710003, China.'}, {'ForeName': 'Xianling', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'The First Clinical College, Shandong University of Traditional Chinese Medicine, Jinan, 250014, China.'}, {'ForeName': 'Zhengao', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Reproductive and Genetic Center of Integrated Traditional and Western Medicine, The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan City, 250011, Shandong Province, China. sunzhengao77@126.com.'}]",Trials,['10.1186/s13063-020-04502-z']
2924,32560735,"Evaluation of the effects of a drug with fiscalized substance dispensation, health education, and pharmacovigilance continuing education program in Colombia drugstores and drugstores/pharmacies: study protocol of a multicenter, cluster-randomized controlled trial.","BACKGROUND


Health disorders, due to the use of drugs with fiscalized substances, including controlled substances, have become a common problem in Colombia. Multiple reasons can help explain this problem, including self-medication, since access to these drugs may be easier. Also, there is a lack of knowledge that these drugs are safer than illicit drugs. The use of these drugs without a valid medical prescription and follow-up can have negative consequences such as drug abuse, addiction, and overdose, and eventually, have negative health consequences. Pharmacy staff is essential to both assure the correct drug use and minimize prescription errors to help outpatients have better management of their pharmacotherapy. For this reason, it is necessary to increase key competencies like knowledge, skills, and attitudes in the pharmacy staff of ambulatory (outpatients) pharmacies.
METHODS


This study is a prospective, cluster-randomized, parallel-group, multicenter trial of drugstores and drugstores/pharmacies (ambulatory pharmacies). The study is designed to determine the effectiveness of a drug with fiscalized substance dispensation, health education, and pharmacovigilance continuing education program in drugstores and drugstores/pharmacies. Pharmacy staff will be randomly selected and assigned to one of the study groups (intervention or control). The intervention group will receive a continuing education program for over 12 months. The control group will receive only general information about the correct use of complex dosage forms. The primary objective is to evaluate the effectiveness of a continuing education program to improve pharmacy staff competencies (knowledge, skills, and attitudes) to improve the ambulatory (outpatient) pharmacy services: dispensation, health education, and pharmacovigilance of drugs with fiscalized substances. The secondary outcomes include (a) processes associated with the management of drugs with fiscalized substances in drugstores and drugstores/pharmacies, including regulation compliance; (b) degree of implementation of ambulatory (outpatient) pharmacy services targeting these drugs in drugstores and drugstores/pharmacies; (c) patient satisfaction with such services; and (d) pharmacy staff satisfaction with the continuing education program.
DISCUSSION


This clinical trial will establish whether providing a continuing education program for the adequate utilization of drugs with fiscalized substances improves pharmacy staff competencies regarding these drugs.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03388567. Registered on 28 November 2017. First drugstore or drugstore/pharmacy randomized on December 1, 2018.
PROTOCOL VERSION


0017102017MC.",2020,Pharmacy staff is essential to both assure the correct drug use and minimize prescription errors to help outpatients have better management of their pharmacotherapy.,"['drugstores and drugstores/pharmacies', 'drugstores and drugstores/pharmacies (ambulatory pharmacies', 'Colombia drugstores and drugstores/pharmacies']","['drug with fiscalized substance dispensation, health education, and pharmacovigilance continuing education program', 'fiscalized substance dispensation, health education, and pharmacovigilance continuing education program', 'continuing education program']","['secondary outcomes include (a) processes associated with the management of drugs with fiscalized substances in drugstores and drugstores/pharmacies, including regulation compliance; (b) degree of implementation of ambulatory (outpatient) pharmacy services targeting these drugs in drugstores and drugstores/pharmacies; (c) patient satisfaction with such services; and (d) pharmacy staff satisfaction with the continuing education program', 'pharmacy staff competencies (knowledge, skills, and attitudes']","[{'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C3245499', 'cui_str': 'Colombia'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3178990', 'cui_str': 'Pharmacovigilance'}, {'cui': 'C0013626', 'cui_str': 'Continuing Education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0013626', 'cui_str': 'Continuing Education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.0432705,Pharmacy staff is essential to both assure the correct drug use and minimize prescription errors to help outpatients have better management of their pharmacotherapy.,"[{'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Ceballos', 'Affiliation': 'Research Group on Pharmaceutical Promotion and Prevention, University of Antioquia, U.de.A. Calle 70 No 52-21, Medellin, Colombia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Salazar-Ospina', 'Affiliation': 'Research Group on Pharmaceutical Promotion and Prevention, University of Antioquia, U.de.A. Calle 70 No 52-21, Medellin, Colombia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Sabater-Hernández', 'Affiliation': 'Pharmaceutical Care Research Group, Faculty of Pharmacy, University of Granada, Granada, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Amariles', 'Affiliation': 'Research Group on Pharmaceutical Promotion and Prevention, University of Antioquia, U.de.A. Calle 70 No 52-21, Medellin, Colombia. pedro.amariles@udea.edu.co.'}]",Trials,['10.1186/s13063-020-04481-1']
2925,32560737,The direct superior approach versus posterior approach for total hip arthroplasty: study protocol for a prospective double-blinded randomised control trial.,"BACKGROUND


The direct superior approach (DSA) is a minimally invasive modification of the posterior approach (PA) that preserves the iliotibial band and short external rotators except for the piriformis or conjoint tendon during total hip arthroplasty (THA). The objective of this study is to compare patient satisfaction, functional outcomes, accuracy of implant positioning, component stability, gait, cost-effectiveness, and complications in the DSA versus PA for THA.
METHODS AND ANALYSIS


This prospective double-blinded randomised control trial will include 80 patients with symptomatic hip osteoarthritis undergoing primary THA. Following informed consent, patients will be randomised to THA using the PA (control group) or DSA (investigation group) at a ratio of 1:1 using an online random number generator. Blinded observers will review patients at regular intervals for 2 years after surgery to record predefined study outcomes relating to postoperative rehabilitation, clinical progress, functional outcomes, accuracy of implant positioning, gait analysis on force plate treadmill, implant migration with radiosteriometric analysis, cost-effectiveness, and complications. A superiority study design will be used to evaluate whether the DSA provides improved outcomes compared to the PA for THA. Evaluation of study outcomes in DSA and PA will be used to quantify and draw inferences on differences in the efficacy of treatment between the two groups. Intention-to-treat and per-protocol population analysis will be undertaken. The following statistical methods will be employed to analyse the data: descriptive statistics, independent t test, paired t test, analysis of variance, Fisher exact test, chi-square test, and graphical displays. Ethical approval was obtained from the London-Fulham Research Ethics Committee, UK. The study is sponsored by University College London, UK.
DISCUSSION


This study compares a comprehensive and robust range of clinical, functional, and radiological outcomes in THA performed using the PA versus DSA. The findings of this study will provide an improved understanding of the differences in the PA versus DSA for THA with respect to patient satisfaction, functional outcomes, implant survivorship, gait, cost-effectiveness, and complications.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT04191993. Registered on 10 December 2019.",2020,"BACKGROUND


The direct superior approach (DSA) is a minimally invasive modification of the posterior approach (PA) that preserves the iliotibial band and short external rotators except for the piriformis or conjoint tendon during total hip arthroplasty (THA).","['University College London, UK', '80 patients with symptomatic hip osteoarthritis undergoing primary THA', 'total hip arthroplasty']","['PA (control group) or DSA', 'direct superior approach versus posterior approach', 'DSA', 'direct superior approach (DSA']","['patient satisfaction, functional outcomes, accuracy of implant positioning, component stability, gait, cost-effectiveness, and complications', 'patient satisfaction, functional outcomes, implant survivorship, gait, cost-effectiveness, and complications', 'postoperative rehabilitation, clinical progress, functional outcomes, accuracy of implant positioning, gait analysis on force plate treadmill, implant migration with radiosteriometric analysis, cost-effectiveness, and complications']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0029410', 'cui_str': 'Osteoarthritis of hip'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0205512', 'cui_str': 'Posterior approach'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0558820', 'cui_str': 'Examination of gait'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",80.0,0.293301,"BACKGROUND


The direct superior approach (DSA) is a minimally invasive modification of the posterior approach (PA) that preserves the iliotibial band and short external rotators except for the piriformis or conjoint tendon during total hip arthroplasty (THA).","[{'ForeName': 'Babar', 'Initials': 'B', 'LastName': 'Kayani', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, University College Hospital, 235 Euston Road, Fitzrovia, London, NW1 2BU, UK. babar.kayani@gmail.com.'}, {'ForeName': 'Sujith', 'Initials': 'S', 'LastName': 'Konan', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, University College Hospital, 235 Euston Road, Fitzrovia, London, NW1 2BU, UK.'}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Tahmassebi', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, University College Hospital, 235 Euston Road, Fitzrovia, London, NW1 2BU, UK.'}, {'ForeName': 'Atif', 'Initials': 'A', 'LastName': 'Ayuob', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, University College Hospital, 235 Euston Road, Fitzrovia, London, NW1 2BU, UK.'}, {'ForeName': 'Fares S', 'Initials': 'FS', 'LastName': 'Haddad', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, University College Hospital, 235 Euston Road, Fitzrovia, London, NW1 2BU, UK.'}]",Trials,['10.1186/s13063-020-04484-y']
2926,32560739,Efficacy and safety of Zihua Wenfei granules in treatment of postinfectious cough (wind-cold invading lungs syndrome): study protocol for a randomized controlled trial.,"BACKGROUND


Postinfectious cough usually develops and persists following respiratory tract infection. The protracted cough is embarrassing and troublesome and significantly impairs daily life. However, the optimal treatment available for this condition is still not known. This study aims to investigate the efficacy and safety of a new Chinese herbal prescription, Zihua Wenfei granule (ZHWFG), in treatment of postinfectious cough (wind-cold invading lungs syndrome).
METHODS


This study is a prospective, multi-center, randomized, double-blinded, parallel group, placebo-controlled trial. A total of 216 adult participants with postinfectious cough will be enrolled from six study centers across China. All participants are randomly allocated to one of three parallel treatment groups: (1) 15 g of active ZHWFG three times daily, (2) 10 g of active ZHWFG plus 5 g of ZHWFG-matched placebo three times daily, and (3) 15 g of ZHWFG-matched placebo three times daily. The treatment duration is 14 consecutive days. The primary outcomes are cough resolution rate and cough relief rate. Secondary outcomes include time to cough resolution, time to cough relief, change from baseline in cough symptom score, cough visual analog scale value, traditional Chinese medicine syndrome score at days 7 and 14, and change of CQLQ from baseline to post-treatment as well as adverse events.
DISCUSSION


This trial may not only investigate the efficacy and safety of ZHWFG in the management of postinfectious cough (wind-cold invading lungs syndrome), but also add the evidence of Chinese herbal medicine in treatment of postinfectious cough and provide an alternative option for the management of postinfectious cough.
TRIAL REGISTRATION


ChiCTR1900022078. Registered on 23 March 2019. http://www.chictr.org.cn/showproj.aspx?proj=36547.",2020,"This trial may not only investigate the efficacy and safety of ZHWFG in the management of postinfectious cough (wind-cold invading lungs syndrome), but also add the evidence of Chinese herbal medicine in treatment of postinfectious cough and provide an alternative option for the management of postinfectious cough.
","['216 adult participants with postinfectious cough will be enrolled from six study centers across China', 'postinfectious cough (wind-cold invading lungs syndrome']","['ZHWFG-matched placebo', 'ZHWFG', 'Zihua Wenfei granules', 'active ZHWFG three times daily, (2) 10\u2009g of active ZHWFG plus 5\u2009g of ZHWFG-matched placebo', 'new Chinese herbal prescription, Zihua Wenfei granule (ZHWFG', 'placebo']","['cough resolution rate and cough relief rate', 'efficacy and safety', 'Efficacy and safety', 'time to cough resolution, time to cough relief, change from baseline in cough symptom score, cough visual analog scale value, traditional Chinese medicine syndrome score at days 7 and 14, and change of CQLQ from baseline to post-treatment as well as adverse events']","[{'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}]","[{'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",216.0,0.424958,"This trial may not only investigate the efficacy and safety of ZHWFG in the management of postinfectious cough (wind-cold invading lungs syndrome), but also add the evidence of Chinese herbal medicine in treatment of postinfectious cough and provide an alternative option for the management of postinfectious cough.
","[{'ForeName': 'Huanan', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, 37 Guoxue Lane, Chengdu, 610041, Sichuan Province, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'She', 'Affiliation': 'Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, 37 Guoxue Lane, Chengdu, 610041, Sichuan Province, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Mao', 'Affiliation': 'Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, 37 Guoxue Lane, Chengdu, 610041, Sichuan Province, China.'}, {'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, 37 Guoxue Lane, Chengdu, 610041, Sichuan Province, China. doc_jhl@163.com.'}]",Trials,['10.1186/s13063-020-04487-9']
2927,32554133,A video-game based cognitive training for breast cancer survivors with cognitive impairment: A prospective randomized pilot trial.,"INTRODUCTION


We investigated whether a web-based cognitive training video game is an effective approach to improve cognitive decline in combination with our standard of care for rehabilitation of breast cancer (BC) patients.
MATERIALS AND METHODS


Self-selected BC patients between 18 and 71 years old complaining of disturbing cognitive impairment were studied. The patients received access to a web-based internet video game and online cognitive assessments (Aquasnap, Cambridge, MyCQ™). The early intervention group (n = 23) had a training program of 6 months of at least three times a week for a minimum of 60 min of game playing per week at home in addition to standard of care rehabilitation. The delayed intervention (n = 23) received standard of care for three months, followed by three months of similar MyCQ training. Outcome measures were the MyCQ (sub)scores and Activity of Daily Life (ADL), mood, subjective cognition and functional cognitive status measured by classic neuropsychological tests.
RESULTS


At baseline the means for CFQ (a measure of self-reported cognitive failure), anxiety, PSQI and self-reflectiveness were beyond normal range in both groups. CFQ improved significantly better in the intervention group (p = 0.029). Combining the evolution over time in the entire population a significant improvement was seen for overall MyCQ score, level of fear, physical and emotional role limitation, and health change (all p < 0.05), but self-reflectivess deteriorated (p < 0.05)). Significant differences in the various MyCQ subtests over time were: improved speed in choice reaction time, visual memory recognition, N back 1 and 2, coding, trail making test B, improved accuracy of N back 1 and 2 (all p < 0.05).
CONCLUSION


A program of cognitive training improves cognitive functioning over time. ""Aquasnap"" has a beneficial effect on the perception of subjective cognitive functioning (CFQ) but the exact role of video gaming in this process remains uncertain.",2020,"Significant differences in the various MyCQ subtests over time were: improved speed in choice reaction time, visual memory recognition, N back 1 and 2, coding, trail making test B, improved accuracy of N","['Self-selected BC patients between 18 and 71 years old complaining of disturbing cognitive impairment were studied', 'breast cancer (BC) patients', 'breast cancer survivors with cognitive impairment']","['video-game based cognitive training', 'cognitive training', 'web-based cognitive training video game', 'MyCQ training', 'access to a web-based internet video game and online cognitive assessments (Aquasnap, Cambridge, MyCQ™']","['speed in choice reaction time, visual memory recognition, N back 1 and 2, coding, trail making test B, improved accuracy of N', 'cognitive failure), anxiety, PSQI and self-reflectiveness', 'cognitive functioning', 'MyCQ (sub)scores and Activity of Daily Life (ADL), mood, subjective cognition and functional cognitive status measured by classic neuropsychological tests', 'overall MyCQ score, level of fear, physical and emotional role limitation, and health change', 'CFQ']","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0542316', 'cui_str': 'Visual memory'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1319227', 'cui_str': 'Level of fear'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0411642,"Significant differences in the various MyCQ subtests over time were: improved speed in choice reaction time, visual memory recognition, N back 1 and 2, coding, trail making test B, improved accuracy of N","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bellens', 'Affiliation': 'Multidisciplinary Oncologic Center Antwerp (MOCA), Antwerp University Hospital, Edegem, B2650, Belgium; Centre for Oncological Research (CORE), University of Antwerp, Wilrijk, B2610, Belgium.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Roelant', 'Affiliation': 'Clinical Trial Center (CTC), CRC Antwerp, Antwerp University Hospital, University of Antwerp, Edegem, B2650, Belgium; StatUa, Center for Statistics, University of Antwerp, Antwerp, B2000, Belgium.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Sabbe', 'Affiliation': 'Department of Psychiatry, Antwerp University, Wilrijk, Belgium.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Peeters', 'Affiliation': 'Multidisciplinary Oncologic Center Antwerp (MOCA), Antwerp University Hospital, Edegem, B2650, Belgium; Centre for Oncological Research (CORE), University of Antwerp, Wilrijk, B2610, Belgium.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'van Dam', 'Affiliation': 'Multidisciplinary Oncologic Center Antwerp (MOCA), Antwerp University Hospital, Edegem, B2650, Belgium; Centre for Oncological Research (CORE), University of Antwerp, Wilrijk, B2610, Belgium. Electronic address: peter.vandam@telenet.be.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.06.003']
2928,32554135,The relationship between the tympanostomy tube extrusion time and viscosity.,"OBJECTIVE


The purpose of the study was to assess the correlation between the tympanostomy tube extrusion time and the viscosity of the middle ear fluid.
METHODS


Thirty-three patients who were scheduled for a tympanostomy tube (TT) insertion were included in the study. During the paracentesis procedure, fluid from the middle ear was obtained, and the viscosity was measured with a viscometer. Patients with effusion values below and above the median viscosity value of 439 cP (cP) were assigned to Group 1 and Group 2, respectively. After the surgery, the patients were followed up monthly until the tubes were observed to be extruded.
RESULTS


The analysis of the correlation between the tube extrusion time and the viscosity was statistically insignificant (p > 0.05). The mean tube extrusion time of Group 1 (12.65 ± 4.152 months) was slightly lower than that of Group 2 (13.81 ± 4.43 months); however, the difference was not statistically significant.
CONCLUSION


The tube extrusion time can be longer or shorter and is independent of the effusion viscosity. Further studies are needed to clarify the factors that affect the TT extrusion time.
TRIAL REGISTRATION NUMBER


NCT03848026.",2020,The analysis of the correlation between the tube extrusion time and the viscosity was statistically insignificant (p > 0.05).,"['Patients with effusion values below and above the median viscosity value of 439\xa0cP (cP', 'Thirty-three patients who were scheduled for a tympanostomy tube (TT) insertion were included in the study']",[],"['mean tube extrusion time', 'tube extrusion time and the viscosity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013687', 'cui_str': 'Effusion'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0850121', 'cui_str': 'Tympanic ventilation tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0443213', 'cui_str': 'Extrusion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}]",33.0,0.0301946,The analysis of the correlation between the tube extrusion time and the viscosity was statistically insignificant (p > 0.05).,"[{'ForeName': 'Nazan', 'Initials': 'N', 'LastName': 'Degirmenci', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: ndegirmenci@bezmialem.edu.tr.'}, {'ForeName': 'Selahattin', 'Initials': 'S', 'LastName': 'Tugrul', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: selahattintugrul@yahoo.com.'}, {'ForeName': 'Seda Sezen', 'Initials': 'SS', 'LastName': 'Goktas', 'Affiliation': '75. Yil Boyabat State Hospital, Department of Otorhinolaryngology and Head and Neck Surgery, Sinop, Turkey. Electronic address: sedasezengoktas@gmail.com.'}, {'ForeName': 'Erol', 'Initials': 'E', 'LastName': 'Senturk', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: erolsent@gmail.com.'}, {'ForeName': 'Omer Faruk', 'Initials': 'OF', 'LastName': 'Calim', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: omercalim@yahoo.com.'}, {'ForeName': 'Remzi', 'Initials': 'R', 'LastName': 'Dogan', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: dr.remzidogan@hotmail.com.'}, {'ForeName': 'Alper', 'Initials': 'A', 'LastName': 'Yenigun', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: alperyenigun@gmail.com.'}, {'ForeName': 'Orhan', 'Initials': 'O', 'LastName': 'Ozturan', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: orhanent@yahoo.com.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110140']
2929,32554173,Neuroendocrine biomarkers of prolonged exposure treatment response in military-related PTSD.,"Posttraumatic stress disorder (PTSD) is associated with dysregulation of the neuroendocrine system, including cortisol, allopregnanolone, and pregnanolone. Preliminary evidence from animal models suggests that baseline levels of these biomarkers may predict response to PTSD treatment. We report the change in biomarkers over the course of PTSD treatment. Biomarkers were sampled from individuals participating in (1) a randomized controlled trial comparing a web-version of Prolonged Exposure (Web-PE) therapy to in-person Present-Centered Therapy (PCT) and (2) from individuals participating in a nonrandomized effectiveness study testing PE delivered in-person as part of an intensive outpatient PTSD program. We found that higher cortisol reactivity during script-driven imagery was associated with higher baseline PTSD severity and that baseline allopregnanolone, pregnanolone, and cortisol reactivity were associated with degree of symptom change over the course of intensive outpatient treatment. These findings demonstrate that peripherally assessed biomarkers are associated with PTSD severity and likelihood of successful treatment outcome of PE delivered daily over two weeks. These assessments could be used to determine which patients are likely to respond to treatment and which patients require augmentation to increase the likelihood of optimal response to PTSD treatment.",2020,"Posttraumatic stress disorder (PTSD) is associated with dysregulation of the neuroendocrine system, including cortisol, allopregnanolone, and pregnanolone.","['military-related PTSD', 'Posttraumatic stress disorder (PTSD']","['web-version of Prolonged Exposure (Web-PE) therapy to in-person Present-Centered Therapy (PCT', 'pregnanolone']",['higher cortisol reactivity'],"[{'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033008', 'cui_str': '3 alpha, 5 beta-Tetrahydroprogesterone'}]","[{'cui': 'C0541847', 'cui_str': 'Cortisol increased'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",,0.0279829,"Posttraumatic stress disorder (PTSD) is associated with dysregulation of the neuroendocrine system, including cortisol, allopregnanolone, and pregnanolone.","[{'ForeName': 'Sheila A M', 'Initials': 'SAM', 'LastName': 'Rauch', 'Affiliation': 'Atlanta VA Medical Center, 1670 Clairmont Road, Decatur, GA, 30033, USA; Emory University School of Medicine, Department of Psychiatry and Behavioral Sciences, 12 Executive Park, 3rd Floor, Atlanta, GA, 30029, USA. Electronic address: sheila.a.m.rauch@emory.edu.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Sripada', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI, 48105, USA; University of Michigan, Department of Psychiatry, 4250 Plymouth Road, Ann Arbor, MI, 48109, USA. Electronic address: rekaufma@med.umich.edu.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Burton', 'Affiliation': 'Emory University School of Medicine, Department of Psychiatry and Behavioral Sciences, 12 Executive Park, 3rd Floor, Atlanta, GA, 30029, USA. Electronic address: mark.steven.burton@emory.edu.'}, {'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Michopoulos', 'Affiliation': 'Emory University School of Medicine, Department of Psychiatry and Behavioral Sciences, 12 Executive Park, 3rd Floor, Atlanta, GA, 30029, USA. Electronic address: vmichop@emory.edu.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Kerley', 'Affiliation': 'Emory University School of Medicine, Department of Psychiatry and Behavioral Sciences, 12 Executive Park, 3rd Floor, Atlanta, GA, 30029, USA. Electronic address: kimberly.kerley@emory.edu.'}, {'ForeName': 'Christine E', 'Initials': 'CE', 'LastName': 'Marx', 'Affiliation': 'Duke University School of Medicine, Department of Psychiatry and Behavioral Sciences, 40 Duke Medicine Circle, Durham, NC, 27710, USA; Durham Veterans Administration Medical Center and VA Mid-Atlantic MIRECC, 508 Fulton Street, Durham, NC, 27705, USA. Electronic address: christine.marx@duke.edu.'}, {'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Kilts', 'Affiliation': 'Duke University School of Medicine, Department of Psychiatry and Behavioral Sciences, 40 Duke Medicine Circle, Durham, NC, 27710, USA; Durham Veterans Administration Medical Center and VA Mid-Atlantic MIRECC, 508 Fulton Street, Durham, NC, 27705, USA. Electronic address: jason.kilts@duke.edu.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Naylor', 'Affiliation': 'Duke University School of Medicine, Department of Psychiatry and Behavioral Sciences, 40 Duke Medicine Circle, Durham, NC, 27710, USA; Durham Veterans Administration Medical Center and VA Mid-Atlantic MIRECC, 508 Fulton Street, Durham, NC, 27705, USA. Electronic address: jennifer.naylor@duke.edu.'}, {'ForeName': 'Barbara O', 'Initials': 'BO', 'LastName': 'Rothbaum', 'Affiliation': 'Emory University School of Medicine, Department of Psychiatry and Behavioral Sciences, 12 Executive Park, 3rd Floor, Atlanta, GA, 30029, USA. Electronic address: brothba@emory.edu.'}, {'ForeName': 'Carmen P', 'Initials': 'CP', 'LastName': 'McLean', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Health Care System, 795 Willow Rd, Menlo Park, CA, 94025, USA; Stanford University School of Medicine, Department of Psychiatry and Behavioral Sciences, 291 Campus Dr., Stanford, CA, 94305, USA. Electronic address: Carmen.McLean4@va.gov.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Emory University School of Medicine, Department of Obstetrics and Gynecology, 101 Woodruff Circle NE, Ste 4217, Atlanta, 30322, USA. Electronic address: alicia.smith@emory.edu.'}, {'ForeName': 'Seth D', 'Initials': 'SD', 'LastName': 'Norrholm', 'Affiliation': 'Atlanta VA Medical Center, 1670 Clairmont Road, Decatur, GA, 30033, USA; Wayne State University, 3901 Chrysler Dr, Detroit, MI, 48201, USA. Electronic address: SNorrholm@wayne.edu.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Jovanovic', 'Affiliation': 'Wayne State University, 3901 Chrysler Dr, Detroit, MI, 48201, USA. Electronic address: tjovanovic@med.wayne.edu.'}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Liberzon', 'Affiliation': 'Texas A&M University, 8447 Riverside Parkway, Bryan, TX, 77808-3260, USA. Electronic address: liberzon@tamu.edu.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Williamson', 'Affiliation': 'Duke University School of Medicine, Department of Psychiatry and Behavioral Sciences, 40 Duke Medicine Circle, Durham, NC, 27710, USA; Durham Veterans Administration Medical Center and VA Mid-Atlantic MIRECC, 508 Fulton Street, Durham, NC, 27705, USA. Electronic address: douglas.williamson@duke.edu.'}, {'ForeName': 'Col Jeffrey S', 'Initials': 'CJS', 'LastName': 'Yarvis', 'Affiliation': 'Carl R. Darnall Army Medical Center, Department of Behavioral Health, 36065 Santa Fe Ave., Fort Hood, TX, 76544, USA. Electronic address: jeffrey.s.yarvis.mil@mail.mil.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Dondanville', 'Affiliation': 'University of Texas Health Science Center at San Antonio, Department of Psychiatry and Behavioral Sciences, 7703 Floyd Curl Dr., San Antonio, TX, 78229, USA. Electronic address: Dondanville@uthscsa.edu.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Young-McCaughan', 'Affiliation': 'University of Texas Health Science Center at San Antonio, Department of Psychiatry and Behavioral Sciences, 7703 Floyd Curl Dr., San Antonio, TX, 78229, USA. Electronic address: youngs1@uthscsa.edu.'}, {'ForeName': 'Terence M', 'Initials': 'TM', 'LastName': 'Keane', 'Affiliation': 'VA Boston Healthcare System, National Center for PTSD (116B-2), 150 South Huntington Avenue, Boston, MA, 02130, USA; Boston University School of Medicine, Department of Psychiatry, 720 Harrison Avenue, Room 906, Boston, MA, 02118, USA. Electronic address: Terry.Keane@va.gov.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Peterson', 'Affiliation': 'University of Texas Health Science Center at San Antonio, Department of Psychiatry and Behavioral Sciences, 7703 Floyd Curl Dr., San Antonio, TX, 78229, USA; South Texas Veterans Health Care System, Research and Development Service, 7400 Merton Minter, San Antonio, TX, 78229, USA; University of Texas at San Antonio, Department of Psychology, One UTSA Circle, San Antonio, TX, 78249, USA. Electronic address: petersona3@uthscsa.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104749']
2930,32554183,The interactive effects of test-retest and methylphenidate administration on cognitive performance in youth with ADHD: A double-blind placebo-controlled crossover study.,"Studies have shown that Methylphenidate (MPH) affects cognitive performance on the neuropsychological tests and clinical symptoms of individuals diagnosed with attention deficit/hyperactivity disorder (ADHD). This study investigated the acute effects of MPH on neuropsychological tests to explore the interaction between MPH and test-retest effects. Twenty youths with ADHD were tested before and after MPH intake in a double-blind placebo-controlled crossover design and compared to twenty matched controls. Participants were tested on a range of standardized tasks including sustained attention to response, N-Back, and Word/Color Stroop. Identical tasks were administered twice each testing day, before and 1 hour after MPH/Placebo administration. Healthy controls were tested similarly with no intervention. Decreases in response time (RT) variability across tasks and in commission errors were found in ADHD after MPH. Conversely, a significant increase in RT variability and increase in omission errors were observed after the placebo. In the control group, RT variability and omission errors increased whereas commission errors decreased, suggesting fatigue and practice effects, respectively. Test-retest reliability was higher in controls than ADHD. It is suggested that cognitive tests are sensitive objective measures for the assessment of responses to MPH in ADHD but are also affected by repetition and fatigue.",2020,"In the control group, RT variability and omission errors increased whereas commission errors decreased, suggesting fatigue and practice effects, respectively.","['youth with ADHD', 'individuals diagnosed with attention deficit/hyperactivity disorder (ADHD', 'Twenty youths with ADHD']","['Methylphenidate (MPH', 'methylphenidate', 'placebo']","['cognitive performance', 'RT variability and omission errors', 'Test-retest reliability', 'sustained attention to response, N-Back, and Word/Color Stroop', 'RT variability', 'response time (RT) variability across tasks and in commission errors', 'omission errors', 'commission errors']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0009393', 'cui_str': 'Color'}]",20.0,0.196672,"In the control group, RT variability and omission errors increased whereas commission errors decreased, suggesting fatigue and practice effects, respectively.","[{'ForeName': 'Itai', 'Initials': 'I', 'LastName': 'Horowitz', 'Affiliation': ""Ruth Rappaport Children's Hospital, Rambam Medical Center, Haifa, Israel; Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: itaizen@gmail.com.""}, {'ForeName': 'Keren', 'Initials': 'K', 'LastName': 'Avirame', 'Affiliation': ""Ruth Rappaport Children's Hospital, Rambam Medical Center, Haifa, Israel; Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.""}, {'ForeName': 'Jodie', 'Initials': 'J', 'LastName': 'Naim-Feil', 'Affiliation': 'Department of Physics of Complex Systems, The Weizmann Institute of Science, Rehovot, Israel; Sagol Center for Brain and Mind, Baruch Ivcher School of Psychology, Interdisciplinary Center (IDC), Herzliya, Israel.'}, {'ForeName': 'Mica', 'Initials': 'M', 'LastName': 'Rubinson', 'Affiliation': 'Department of Physics of Complex Systems, The Weizmann Institute of Science, Rehovot, Israel.'}, {'ForeName': 'Elisha', 'Initials': 'E', 'LastName': 'Moses', 'Affiliation': 'Department of Physics of Complex Systems, The Weizmann Institute of Science, Rehovot, Israel.'}, {'ForeName': 'Doron', 'Initials': 'D', 'LastName': 'Gothelf', 'Affiliation': ""Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Child and Adolescent Psychiatry Division, The Edmond and Lily Safra Children's Hospital, Sheba Medical Center, Israel; Sagol School of Neuroscience, Tel Aviv University, Tel Aviv, Israel.""}, {'ForeName': 'Nava', 'Initials': 'N', 'LastName': 'Levit-Binnun', 'Affiliation': 'Sagol Center for Brain and Mind, Baruch Ivcher School of Psychology, Interdisciplinary Center (IDC), Herzliya, Israel.'}]",Psychiatry research,['10.1016/j.psychres.2020.113056']
2931,32554218,Potential benefits of environmental volunteering programs of the health of older adults: a pilot study.,"PURPOSE


To study the effects of participating in a 12-week environmental volunteering program on the physical performance of older adults across different age groups MATERIALS AND METHODS: We conducted a pretest-posttest pilot study with a single group. The intervention consisted of twice-weekly recycling activities and once-weekly rehabilitation exercise at community-based care centers. The recycling activities of the environmental volunteering program included sorting and handling paper products, plastics, and metals; disposing electronic products; and sorting clothes. The rehabilitation exercise program comprised a 90-min course for special needs and 30 min of health education. The evaluation tools were the handgrip strength, five-times-sit-to-stand test, sit-and-reach test, Timed Up and Go (TUG) test and usual and fast gait speeds.
RESULTS


In total, 45 participants completed the program. After the program, the participants showed significantly great improvements compared to baseline in all outcome measures. We further divided these participants into two age subgroups [65-75 years (n = 31) and >75 years (n = 14)]. The 65-75-year subgroup only showed significant improvements in handgrip strength, TUG and usual gait speed. However, the >75-year subgroup showed significant improvements in all outcome measures.
CONCLUSIONS


This innovative environmental volunteering program conducted in a local Taiwanese community can be a sustainable and feasible model to improve physical performance in the participants, the subgroup aged >75 years in particular. It also provides a potential avenue for researchers and policymakers to address environmental and aging-related issues.",2020,"The 65-75-year subgroup only showed significant improvements in handgrip strength, TUG and usual gait speed.","['older adults across different age groups', 'older adults', 'participants into two age subgroups [65-75 years (n\u2009=\u200931) and >75 years (n\u2009=\u200914', 'participants, the subgroup aged >75 years in particular', '45 participants completed the program']","['twice-weekly recycling activities and once-weekly rehabilitation exercise at community-based care centers', 'rehabilitation exercise program', 'environmental volunteering program', 'environmental volunteering programs']","['handgrip strength, TUG and usual gait speed', 'handgrip strength, five-times-sit-to-stand test, sit-and-reach test, Timed Up and Go (TUG) test and usual and fast gait speeds']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0282114', 'cui_str': 'Recycling'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]",45.0,0.0265483,"The 65-75-year subgroup only showed significant improvements in handgrip strength, TUG and usual gait speed.","[{'ForeName': 'Jia-Ching', 'Initials': 'JC', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan; Department of Physical Therapy, Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Qi-Xing', 'Initials': 'QX', 'LastName': 'Chang', 'Affiliation': 'Department of Rehabilitation Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan.'}, {'ForeName': 'Chung-Chao', 'Initials': 'CC', 'LastName': 'Liang', 'Affiliation': 'Department of Rehabilitation Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan; Department of Medicine, Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Jyh-Gang', 'Initials': 'JG', 'LastName': 'Hsieh', 'Affiliation': 'Department of Family Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan.'}, {'ForeName': 'Peter Pin-Sung', 'Initials': 'PP', 'LastName': 'Liu', 'Affiliation': 'Center for Aging and Health, Buddhist Tzu Chi General Hospital, Hualien, Taiwan.'}, {'ForeName': 'Chia-Feng', 'Initials': 'CF', 'LastName': 'Yen', 'Affiliation': 'Department of Public Health, Tzu Chi University, Hualien, Taiwan. Electronic address: mapleyeng@gmail.com.'}, {'ForeName': 'Ching-Hui', 'Initials': 'CH', 'LastName': 'Loh', 'Affiliation': 'Department of Family Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan; Center for Aging and Health, Buddhist Tzu Chi General Hospital, Hualien, Taiwan. Electronic address: twdoc1960@gmail.com.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104113']
2932,32554291,Community level interventions for pre-eclampsia (CLIP) in India: A cluster randomised controlled trial.,"OBJECTIVES


Pregnancy hypertension is associated with 7.1% of maternal deaths in India. The objective of this trial was to assess whether task-sharing care might reduce adverse pregnancy outcomes related to delays in triage, transport, and treatment.
STUDY DESIGN


The Indian Community-Level Interventions for Pre-eclampsia (CLIP) open-label cluster randomised controlled trial (NCT01911494) recruited pregnant women in 12 clusters (initial four-cluster internal pilot) in Belagavi and Bagalkote, Karnataka. The CLIP intervention (6 clusters) consisted of community engagement, community health workers (CHW) provided mobile health (mHeath)-guided clinical assessment, initial treatment, and referral to facility either urgently (<4 h) or non-urgently (<24 h), dependent on algorithm-defined risk. Treatment effect was estimated by multi-level logistic regression modelling, adjusted for prognostically-significant baseline variables. Predefined secondary analyses included safety and evaluation of the intensity of mHealth-guided CHW-provided contacts.
MAIN OUTCOME MEASURES


20% reduction in composite of maternal, fetal, and newborn mortality and major morbidity.
RESULTS


All 14,783 recruited pregnancies (7839 intervention, 6944 control) were followed-up. The primary outcome did not differ between intervention and control arms (adjusted odds ratio (aOR) 0.92 [95% confidence interval 0.74, 1.15]; p = 0.47; intraclass correlation coefficient 0.013). There were no intervention-related safety concerns following administration of either methyldopa or MgSO 4 , and 401 facility referrals. Compared with intervention arm women without CLIP contacts, those with ≥8 contacts suffered fewer stillbirths (aOR 0.19 [0.10, 0.35]; p < 0.001), at the probable expense of survivable neonatal morbidity (aOR 1.39 [0.97, 1.99]; p = 0.072).
CONCLUSIONS


As implemented, solely community-level interventions focussed on pre-eclampsia did not improve outcomes in northwest Karnataka.",2020,"There were no intervention-related safety concerns following administration of either methyldopa or MgSO 4 , and 401 facility referrals.","['All 14,783 recruited pregnancies (7839 intervention, 6944 control) were followed-up', 'pregnant women in 12 clusters (initial four-cluster internal pilot) in Belagavi and Bagalkote, Karnataka', 'pre-eclampsia (CLIP) in India']","['CLIP intervention (6 clusters) consisted of community engagement, community health workers (CHW) provided mobile health (mHeath)-guided clinical assessment, initial treatment, and referral to facility either urgently (<4\xa0h) or non-urgently', 'task-sharing care', 'Community level interventions', 'methyldopa']","['safety and evaluation of the intensity of mHealth-guided CHW-provided contacts', 'survivable neonatal morbidity', 'composite of maternal, fetal, and newborn mortality and major morbidity']","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0025741', 'cui_str': 'Methyldopa'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",,0.32665,"There were no intervention-related safety concerns following administration of either methyldopa or MgSO 4 , and 401 facility referrals.","[{'ForeName': 'Mrutunjaya B', 'Initials': 'MB', 'LastName': 'Bellad', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India. Electronic address: mbbellad@hotmail.com.""}, {'ForeName': 'Shivaprasad S', 'Initials': 'SS', 'LastName': 'Goudar', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Ashalata A', 'Initials': 'AA', 'LastName': 'Mallapur', 'Affiliation': 'S Nijalingappa Medical College, HSK (Hanagal Shree Kumareshwar) Hospital and Research Centre, Navanagar, Bagalkot, 587102 Karnataka, India.'}, {'ForeName': 'Sumedha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Umesh S', 'Initials': 'US', 'LastName': 'Charantimath', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Geetanjali M', 'Initials': 'GM', 'LastName': 'Katageri', 'Affiliation': 'S Nijalingappa Medical College, HSK (Hanagal Shree Kumareshwar) Hospital and Research Centre, Navanagar, Bagalkot, 587102 Karnataka, India.'}, {'ForeName': 'Umesh Y', 'Initials': 'UY', 'LastName': 'Ramadurg', 'Affiliation': 'S Nijalingappa Medical College, HSK (Hanagal Shree Kumareshwar) Hospital and Research Centre, Navanagar, Bagalkot, 587102 Karnataka, India.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mark Ansermino', 'Affiliation': 'Centre for International Child Health, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Derman', 'Affiliation': 'Global Affairs, 1020 Walnut Street, Thomas Jefferson University, Philadelphia 19107, USA.'}, {'ForeName': 'Dustin T', 'Initials': 'DT', 'LastName': 'Dunsmuir', 'Affiliation': 'Centre for International Child Health, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Narayan V', 'Initials': 'NV', 'LastName': 'Honnungar', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Chandrashekhar', 'Initials': 'C', 'LastName': 'Karadiguddi', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Avinash J', 'Initials': 'AJ', 'LastName': 'Kavi', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Bhalachandra S', 'Initials': 'BS', 'LastName': 'Kodkany', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Nathan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St. Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Payne', 'Affiliation': 'Centre for International Child Health, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Amit P', 'Initials': 'AP', 'LastName': 'Revankar', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St. Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Domena K', 'Initials': 'DK', 'LastName': 'Tu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vidler', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Centre for International Child Health, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre for Global Child Health, Hospital for Sick Children, 525 University Avenue, Suite 702, Toronto M5G 2L3, Canada; Aga Khan University, Stadium Road, P.O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Magee', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St. Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'von Dadelszen', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St. Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pregnancy hypertension,['10.1016/j.preghy.2020.05.008']
2933,32554352,Pilot study on the effects of an adapted physical activity program focused on the quality of life and risk indicators for falls in independent dwelling-women over 65 years.,"Falls can have multiple detrimental consequences in the elderly, and this is particularly relevant for women. To prevent the risk of falling, intervention programmes based on physical exercises focusing on balance appear to be the most efficient, which explains the multiplication of this type of action at the local level. However, these actions are very rarely evaluated.
METHODS


Our sample consists of 26 women (75.0 ± 6.7 years old), randomly assigned to two groups: an intervention group (GI) that has benefited from a balance-oriented adapted physical activity (APA) program focused on balance and conducted in an associative structure; and a control group (GC). Our study aims to evaluate different parameters such as physical (functional mobility, balance), subjective (balanced confidence) and health (quality of life) indicators in women over 65 years of age, living independently at home.
RESULTS


In people completing the program, we observed an improvement in equilibrium capabilities (significant increase in POMA score; p < 0.05), in balance and functional mobility (significant decrease in TUG score; p < 0.01) and in balance confidence (significant increase in ABC-S; p < 0.05).
CONCLUSION


The implementation of a short programme by the associative structure seems to be an interesting approach for the prevention of falls in autonomous elderly women.",2020,"In people completing the program, we observed an improvement in equilibrium capabilities (significant increase in POMA score; p < 0.05), in balance and functional mobility (significant decrease in TUG score; p < 0.01) and in balance confidence (significant increase in ABC-S; p < 0.05).
","['autonomous elderly women', '26 women (75.0 ± 6.7 years old', 'falls in independent dwelling-women over 65 years', 'women over 65 years of age, living independently at home']","['adapted physical activity program', 'intervention group (GI) that has benefited from a balance-oriented adapted physical activity (APA) program focused on balance and conducted in an associative structure; and a control group (GC']","['balance confidence', 'physical (functional mobility, balance), subjective (balanced confidence) and health (quality of life) indicators', 'balance and functional mobility', 'quality of life and risk indicators', 'TUG score', 'POMA score', 'equilibrium capabilities']","[{'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1098057', 'cui_str': 'poly(n-octyl methacrylate)'}]",,0.0200423,"In people completing the program, we observed an improvement in equilibrium capabilities (significant increase in POMA score; p < 0.05), in balance and functional mobility (significant decrease in TUG score; p < 0.01) and in balance confidence (significant increase in ABC-S; p < 0.05).
","[{'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'de Battista', 'Affiliation': 'Univ. Nîmes, EA7352 CHROME/APSY-V, Nîmes, France, Institut méditerranéen des métiers de la longévité (I2ML), Nîmes, France.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Goncalves', 'Affiliation': 'Univ. Nîmes, EA7352 CHROME/APSY-V, Nîmes, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Martinez', 'Affiliation': 'Univ. Nîmes, EA7352 CHROME/APSY-V, Nîmes, France.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Strubel', 'Affiliation': 'Institut méditerranéen des métiers de la longévité (I2ML), Nîmes, France.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Charbonnier', 'Affiliation': 'Univ. Nîmes, EA7352 CHROME/APSY-V, Nîmes, France.'}]",Geriatrie et psychologie neuropsychiatrie du vieillissement,['10.1684/pnv.2020.0859']
2934,32554412,"The Effect of Continuing Education on Dental Hygienists' Knowledge, Attitudes, and Practices Regarding Human Papillomavirus Related Oropharyngeal Cancer.","Purpose:  The purpose of this study was to investigate the effect a continuing education (CE) course had on dental hygienists' knowledge, attitudes, and practices regarding human papillomavirus (HPV) related oropharyngeal cancer (OPC). Methods:  A two-group, experimental post-test only design was used for this study. Randomly selected, licensed dental hygienists in the state of Florida, were recruited by email and assigned to either an experimental or control group. An investigator designed, questionnaire was developed and tested for validity and reliability. The experimental group received a one-hour web-based CE course on HPV related OPC. Six weeks later, a post-test questionnaire was administered to the experimental and control groups via an online platform, Qualtrics®. Data were analyzed using descriptive statistics and analysis of variance (ANOVA). Results:  Out of 302 dental hygienists who agreed to participate, 133 completed the study for a participation rate of 44.0%. The knowledge score for the experimental group was 72.6% while the control group scored 58.4%. Results demonstrated statistically significant differences between the groups in terms of knowledge (F=33.81, df=1,  p =0.00) and attitudes (F=13.91, df=1,  p =0.00). No differences were found in oral examination procedures; however, statistically significant differences (F=7.47, df=1,  p =0.007) were noted for items related to HPV specific examination practices between the two groups. Conclusion:  Additional research is needed to identify what specific types of educational interventions are effective in increasing the HPV-related OPC knowledge and practice behaviors of dental hygienists.",2020,"Results demonstrated statistically significant differences between the groups in terms of knowledge (F=33.81, df=1,  p =0.00) and attitudes (F=13.91, df=1,  p =0.00).","['Randomly selected, licensed dental hygienists in the state of Florida, were recruited by email and assigned to either an experimental or control group', '302 dental hygienists who agreed to participate']",['continuing education (CE'],"['knowledge score', 'knowledge', 'oral examination procedures', 'HPV specific examination practices']","[{'cui': 'C0023636', 'cui_str': 'Licenses'}, {'cui': 'C0011369', 'cui_str': 'Dental hygienist'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0016253', 'cui_str': 'Florida'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0013626', 'cui_str': 'Continuing Education'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376306', 'cui_str': 'Oral examination'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",302.0,0.0251556,"Results demonstrated statistically significant differences between the groups in terms of knowledge (F=33.81, df=1,  p =0.00) and attitudes (F=13.91, df=1,  p =0.00).","[{'ForeName': 'Toni M', 'Initials': 'TM', 'LastName': 'McLeroy', 'Affiliation': ''}, {'ForeName': 'JoAnn', 'Initials': 'J', 'LastName': 'Gurenlian', 'Affiliation': ''}, {'ForeName': 'Ellen J', 'Initials': 'EJ', 'LastName': 'Rogo', 'Affiliation': ''}]",Journal of dental hygiene : JDH,[]
2935,32554514,"Open-Label, Phase 1 Study of Nivolumab Combined With  nab -Paclitaxel Plus Gemcitabine in Advanced Pancreatic Cancer.","PURPOSE


Assess safety and efficacy of nivolumab plus  nab -paclitaxel and gemcitabine in patients with locally advanced/metastatic pancreatic cancer in a 2-part, open-label, phase 1 trial.
EXPERIMENTAL DESIGN


Fifty chemotherapy-naive patients received  nab -paclitaxel 125 mg/m 2  plus gemcitabine 1000 mg/m 2  (days 1, 8, and 15) and nivolumab 3 mg/kg (days 1 and 15) in 28-day cycles. The primary endpoints were dose-limiting toxicities (DLTs; part 1) and grade 3/4 treatment-emergent adverse events (TEAEs) or treatment discontinuation due to TEAEs (parts 1/2). Secondary efficacy endpoints were progression-free survival (PFS), overall survival (OS), and response. Assessment of programmed cell death-ligand 1 (PD-L1) expression was an exploratory endpoint; additional biomarkers were assessed post hoc.
RESULTS


One DLT (hepatitis) was reported in part 1 among 6 DLT-evaluable patients; 48/50 patients experienced grade 3/4 TEAEs and 18 discontinued treatment due to TEAEs. One grade 5 TEAE (respiratory failure) was reported. Median (95% CI) PFS/OS was 5.5 (3.25-7.20 months)/9.9 (6.74-12.16 months) months, respectively (median follow-up for OS, 13.6 months [95% CI, 12.06-23.49 months]). Overall response rate (95% CI) was 18% (8.6%-31.4%). Median PFS/OS was 5.5/9.7 months (PD-L1 <5%) and 6.8/11.6 months (PD-L1 ≥5%), respectively. Proportion of peripheral Ki67+ CD8+/CD4+ cells increased significantly from baseline to cycle 3; median peak on-treatment Ki67+ CD8+ T-cell values were higher in responders than in nonresponders.
CONCLUSIONS


The safety profile of nivolumab plus  nab -paclitaxel and gemcitabine at standard doses in advanced pancreatic cancer was manageable, with no unexpected safety signals. Overall, the clinical results of this study do not support further investigation.",2020,Overall response rate (95% CI) was 18% (8.6%-31.4%).,"['patients with locally advanced/metastatic pancreatic cancer in a 2-part, open-label, phase 1 trial', 'Fifty chemotherapy-naive patients received', 'Advanced Pancreatic Cancer', 'advanced pancreatic cancer']","['Combined With  nab -Paclitaxel', 'Nivolumab', 'Plus Gemcitabine', 'nivolumab plus  nab -paclitaxel and gemcitabine', 'nab -paclitaxel 125 mg/m 2  plus gemcitabine']","['dose-limiting toxicities (DLTs; part 1) and grade 3/4 treatment-emergent adverse events (TEAEs) or treatment discontinuation due to TEAEs (parts 1/2', 'PFS/OS', 'Proportion of peripheral Ki67+ CD8+/CD4+ cells', 'safety and efficacy', 'progression-free survival (PFS), overall survival (OS), and response', 'programmed cell death-ligand 1 (PD-L1) expression', 'Overall response rate', 'Median PFS/OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0346976', 'cui_str': 'Secondary malignant neoplasm of pancreas'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C4319551', 'cui_str': '125'}]","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.111298,Overall response rate (95% CI) was 18% (8.6%-31.4%).,"[{'ForeName': 'Zev A', 'Initials': 'ZA', 'LastName': 'Wainberg', 'Affiliation': 'Division of Hematology/Oncology, David Geffen School of Medicine at UCLA ZWainberg@mednet.ucla.edu.'}, {'ForeName': 'Howard S', 'Initials': 'HS', 'LastName': 'Hochster', 'Affiliation': 'Medical Oncology, Rutgers Cancer Institute of New Jersey.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Kim', 'Affiliation': 'Internal Medicine, UC Davis Comprehensive Cancer Center.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'George', 'Affiliation': 'Medical Oncology, Medical College of Wisconsin.'}, {'ForeName': 'Aparna', 'Initials': 'A', 'LastName': 'Kaylan', 'Affiliation': 'Medicine, Northwestern University.'}, {'ForeName': 'E Gabriela', 'Initials': 'EG', 'LastName': 'Chiorean', 'Affiliation': 'Medicine, University of Washington School of Medicine.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Waterhouse', 'Affiliation': 'Medical Oncology, Oncology Hematology Care, Inc.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Guiterrez', 'Affiliation': 'Medical Oncology, John Theurer Cancer Center.'}, {'ForeName': 'Aparna R', 'Initials': 'AR', 'LastName': 'Parikh', 'Affiliation': 'Division of Hematology and Oncology, Massachusetts General Hospital.'}, {'ForeName': 'Rishi', 'Initials': 'R', 'LastName': 'Jain', 'Affiliation': 'Hematology/Oncology, Fox Chase Cancer Center.'}, {'ForeName': 'Daniel Ricardo', 'Initials': 'DR', 'LastName': 'Carrizosa', 'Affiliation': 'Solid Tumor Oncology, Levine Cancer Institute.'}, {'ForeName': 'Hatem', 'Initials': 'H', 'LastName': 'Soliman', 'Affiliation': ""Department of Women's Oncology and Experimental Therapeutics, Moffitt Cancer Center.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lila', 'Affiliation': 'Translational Development & Diagnostics, Bristol-Myers Squibb (United States).'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Reiss', 'Affiliation': 'Informatics & Predictive Sciences, Bristol-Myers Squibb.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Pierce', 'Affiliation': 'Translational Medicine, Bristol-Myers Squibb (United States).'}, {'ForeName': 'Rafia', 'Initials': 'R', 'LastName': 'Bhore', 'Affiliation': 'Medical Affairs Leadership, Bristol-Myers Squibb (United States).'}, {'ForeName': 'Sibabrata', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Medical Affairs Leadership, Bristol-Myers Squibb (United States).'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Lyons', 'Affiliation': 'Medical Affairs Leadership, Bristol-Myers Squibb (United States).'}, {'ForeName': 'Chrystal U', 'Initials': 'CU', 'LastName': 'Louis', 'Affiliation': 'Medical Affairs Leadership, Bristol-Myers Squibb (United States).'}, {'ForeName': 'Teng J', 'Initials': 'TJ', 'LastName': 'Ong', 'Affiliation': 'Medical Affairs Leadership, Bristol-Myers Squibb (United States).'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': ""O'Dwyer"", 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0099']
2936,32554534,Changes in respiratory symptoms during 48 weeks treatment with ARD-3150 (inhaled liposomal ciprofloxacin) in bronchiectasis: results from the ORBIT-3 and -4 studies.,"INTRODUCTION


It is not known if inhaled antibiotics improve respiratory symptoms in patients with bronchiectasis. In the recent phase-3 ORBIT trials, 48-weeks treatment with ARD-3150 (inhaled liposomal ciprofloxacin) did not significantly improve symptoms using the prespecified method of analysis comparing baseline symptoms to those after 48 weeks, when patients had been off treatment for 28 days. This method of analysis does not take account of possible improvements in symptoms while on active treatment.
METHODS


A post-hoc analysis of 2 identical randomised trials of ARD-3150 (ORBIT-3 and -4) administered 28-days on and 28 days off in patients with bronchiectasis and chronic  Pseudomonas aeruginosa  infection. The quality of life bronchiectasis respiratory symptom scale (QOL-B-RSS), which has a 1-week recall period, was administered every 28-days. We examined whether respiratory symptoms improved during on-treatment periods and the relationship of changes in QOL-B-RSS to changes in bacterial load using a mixed model repeated measures approach.
RESULTS


ARD-3150 treatment resulted in a significant improvement in respiratory symptoms during the on-treatment periods with concordant results between ORBIT-3 (estimate 1.4 points, standard error (se) 0.49, p=0.004) and ORBIT-4 (estimate 1.1 point, SE0.41, p=0.006). The proportion of patients achieving a symptom improvement above the minimum clinically important difference was higher with ARD-3150 compared to placebo during on-treatment cycles (p=0.024). Changes in respiratory symptoms were correlated with changes in bacterial load in the treatment group (r=-0.89, p<0.0001). Individual estimates for decrements in the QOL-B RSS during exacerbation were -9.4 points (se 0.91) in ORBIT-3 and -10.8 points (0.74) in ORBIT-4 (both p<0.0001).
CONCLUSION


Inhaled ARD-3150 resulted in significant improvements in respiratory symptoms during the on-treatment periods which were lost during off-treatment periods. These results supports the concept that reducing bacterial load can improve respiratory symptoms in patients with bronchiectasis.",2020,The proportion of patients achieving a symptom improvement above the minimum clinically important difference was higher with ARD-3150 compared to placebo during on-treatment cycles (p=0.024).,"['bronchiectasis', 'patients with bronchiectasis', 'patients with bronchiectasis and chronic  Pseudomonas aeruginosa  infection']","['ARD-3150', 'ARD-3150 (inhaled liposomal ciprofloxacin', 'Inhaled ARD-3150', 'placebo']","['proportion of patients achieving a symptom improvement', 'quality of life bronchiectasis respiratory symptom scale (QOL-B-RSS', 'respiratory symptoms']","[{'cui': 'C0006267', 'cui_str': 'Bronchiectasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0033809', 'cui_str': 'Pseudomonas aeruginosa'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0006267', 'cui_str': 'Bronchiectasis'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0175693', 'cui_str': 'Russell-Silver syndrome'}]",,0.119268,The proportion of patients achieving a symptom improvement above the minimum clinically important difference was higher with ARD-3150 compared to placebo during on-treatment cycles (p=0.024).,"[{'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Chalmers', 'Affiliation': 'University of Dundee, Dundee, UK jchalmers@dundee.ac.uk.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cipolla', 'Affiliation': 'Insmed Incorporated, Bridgewater, NJ, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Thompson', 'Affiliation': 'Aradigm Corporation, Hayward, CA, USA.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Davis', 'Affiliation': 'Theta Hat Statistical Consultants LLC, Owings Mills, MD, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': ""O'Donnell"", 'Affiliation': 'Grifols, Research Triangle Park, NC, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Tino', 'Affiliation': 'Georgetown University, Washington, DC, USA.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Gonda', 'Affiliation': 'Aradigm Corporation, Hayward, CA, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Haworth', 'Affiliation': 'Respidex LLC, Dennis, MA USA.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Froehlich', 'Affiliation': 'Aradigm Corporation, Hayward, CA, USA.'}]",The European respiratory journal,['10.1183/13993003.00110-2020']
2937,32554566,Use of an electronic decision support tool to reduce polypharmacy in elderly people with chronic diseases: cluster randomised controlled trial.,"OBJECTIVE


To evaluate the effects of a computerised decision support tool for comprehensive drug review in elderly people with polypharmacy.
DESIGN


Pragmatic, multicentre, cluster randomised controlled trial.
SETTING


359 general practices in Austria, Germany, Italy, and the United Kingdom.
PARTICIPANTS


3904 adults aged 75 years and older using eight or more drugs on a regular basis, recruited by their general practitioner.
INTERVENTION


A newly developed electronic decision support tool comprising a comprehensive drug review to support general practitioners in deprescribing potentially inappropriate and non-evidence based drugs. Doctors were randomly allocated to either the electronic decision support tool or to provide treatment as usual.
MAIN OUTCOME MEASURES


The primary outcome was the composite of unplanned hospital admission or death by 24 months. The key secondary outcome was reduction in the number of drugs.
RESULTS


3904 adults were enrolled between January and October 2015. 181 practices and 1953 participants were assigned to electronic decision support (intervention group) and 178 practices and 1951 participants to treatment as usual (control group). The primary outcome (composite of unplanned hospital admission or death by 24 months) occurred in 871 (44.6%) participants in the intervention group and 944 (48.4%) in the control group. In an intention-to-treat analysis the odds ratio of the composite outcome was 0.88 (95% confidence interval 0.73 to 1.07; P=0.19, 997 of 1953  v  1055 of 1951). In an analysis restricted to participants attending practice according to protocol, a difference was found favouring the intervention (odds ratio 0.82, 95% confidence interval 0.68 to 0.98; 774 of 1682  v  873 of 1712, P=0.03). By 24 months the number of prescribed drugs had decreased in the intervention group compared with control group (uncontrolled mean change -0.42  v  0.06: adjusted mean difference -0.45, 95% confidence interval -0.63 to -0.26; P<0.001).
CONCLUSIONS


In intention-to-treat analysis, a computerised decision support tool for comprehensive drug review of elderly people with polypharmacy showed no conclusive effects on the composite of unplanned hospital admission or death by 24 months. Nonetheless, a reduction in drugs was achieved without detriment to patient outcomes.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN10137559.",2020,"By 24 months the number of prescribed drugs had decreased in the intervention group compared with control group (uncontrolled mean change -0.42  v  0.06: adjusted mean difference -0.45, 95% confidence interval -0.63 to -0.26; P<0.001).
","['elderly people with polypharmacy', '3904 adults were enrolled between January and October 2015', '181 practices and 1953 participants', 'elderly people with chronic diseases', '359 general practices in Austria, Germany, Italy, and the United Kingdom', '3904 adults aged 75 years and older using eight or more drugs on a regular basis, recruited by their general practitioner']","['electronic decision support tool', 'electronic decision support tool or to provide treatment as usual', 'computerised decision support tool', 'electronic decision support (intervention group) and 178 practices and 1951 participants to treatment as usual (control group']","['number of drugs', 'unplanned hospital admission or death by 24 months', 'composite of unplanned hospital admission or death by 24 months', 'number of prescribed drugs']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0017319', 'cui_str': 'General physician'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0870393', 'cui_str': 'Decision support tool'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",3904.0,0.221708,"By 24 months the number of prescribed drugs had decreased in the intervention group compared with control group (uncontrolled mean change -0.42  v  0.06: adjusted mean difference -0.45, 95% confidence interval -0.63 to -0.26; P<0.001).
","[{'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Rieckert', 'Affiliation': 'Institute of General Practice and Family Medicine, Witten/Herdecke University, Alfred-Herrhausen-Strasse 50, 58448 Witten, Germany Anja.Rieckert@uni-wh.de.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Reeves', 'Affiliation': 'National Institute for Health Research School for Primary Care Research, School of Health Sciences, University of Manchester, UK.'}, {'ForeName': 'Attila', 'Initials': 'A', 'LastName': 'Altiner', 'Affiliation': 'Institute of General Practice, Rostock University Medical Center, Rostock, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Drewelow', 'Affiliation': 'Institute of General Practice, Rostock University Medical Center, Rostock, Germany.'}, {'ForeName': 'Aneez', 'Initials': 'A', 'LastName': 'Esmail', 'Affiliation': 'National Institute for Health Research School for Primary Care Research, School of Health Sciences, University of Manchester, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Flamm', 'Affiliation': 'Institute of General Practice, Family Medicine and Preventive Medicine, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hann', 'Affiliation': 'Centre for Biostatistics, School for Health Sciences, University of Manchester, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Johansson', 'Affiliation': 'Institute of General Practice, Family Medicine and Preventive Medicine, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Klaassen-Mielke', 'Affiliation': 'Department of Medical Informatics, Biometry and Epidemiology, Ruhr-University Bochum, Germany.'}, {'ForeName': 'Ilkka', 'Initials': 'I', 'LastName': 'Kunnamo', 'Affiliation': 'Duodecim Medical Publications, Helsinki, Finland.'}, {'ForeName': 'Christin', 'Initials': 'C', 'LastName': 'Löffler', 'Affiliation': 'Institute of General Practice, Rostock University Medical Center, Rostock, Germany.'}, {'ForeName': 'Giuliano', 'Initials': 'G', 'LastName': 'Piccoliori', 'Affiliation': 'Institute for General Practice of Bolzano, Bolzano, Italy.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Sommerauer', 'Affiliation': 'Institute of General Practice and Family Medicine, Witten/Herdecke University, Alfred-Herrhausen-Strasse 50, 58448 Witten, Germany.'}, {'ForeName': 'Ulrike S', 'Initials': 'US', 'LastName': 'Trampisch', 'Affiliation': 'Institute of General Practice and Family Medicine, Witten/Herdecke University, Alfred-Herrhausen-Strasse 50, 58448 Witten, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Vögele', 'Affiliation': 'Institute for Mountain Emergency Medicine, Eurac Research, Bolzano, Italy.'}, {'ForeName': 'Adrine', 'Initials': 'A', 'LastName': 'Woodham', 'Affiliation': 'National Institute for Health Research School for Primary Care Research, School of Health Sciences, University of Manchester, UK.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Sönnichsen', 'Affiliation': 'National Institute for Health Research School for Primary Care Research, School of Health Sciences, University of Manchester, UK.'}]",BMJ (Clinical research ed.),['10.1136/bmj.m1822']
2938,32554690,Revolutionising participants' health and wellbeing through neuro-reprogramming via the Slimpod ®  app: a randomised controlled trial.,"BACKGROUND


Obesity is a global pandemic that threatens the health of the population and the sustainability of publicly funded health care. This randomised controlled trial addresses the gap in the literature surrounding unconscious persuasion and its use in weight loss and weight management. The Slimpod ®  tool is unlike any of those currently available on the market. Using breakthrough research in 'nudge' thinking, it is designed to retrain an adult's habitual and emotional response to foodstuffs. This therapeutic model allows unconscious thought to be shaped into a manner more consistent with a healthy lifestyle. Candidates can then take control of their eating behaviours to induce a holistic state of wellbeing.
AIM


To assess the effectiveness of an audio unconscious-persuasion weight loss/weight management intervention (Slimpod ® ) compared with audio relaxation (control).
METHOD


Eighty-two overweight adults were randomised to intervention ( n  = 41) and control groups ( n  = 41). Weight was assessed at trial commencement, mid-trial (12 weeks), and trial end (24 weeks). Secondary outcomes were assessed using the Eating Self-Efficacy Scale (ESES), Exercise Confidence Scale (ECS), and Quality of Life Index Generic Version III (QLI-G3) at the start and end of the trial.
RESULTS


Reports found a statistically significant difference in mean weight loss between intervention group (1.7 kg at 12 weeks and 4.3 kg at 24 weeks) versus control (0.6 kg and 1.2 kg respectively) at  P <0.001. ESES scores showed greater self-efficacy ( P  = 0.008) in intervention at 24 weeks. No significant differences in ESES negative affect sub-scale score or ECS were observed.
CONCLUSION


Slimpod ®  was effective at reducing weight and increasing eating self-efficacy in overweight adults.",2020,ESES scores showed greater self-efficacy ( P  = 0.008) in intervention at 24 weeks.,"['overweight adults', ""Revolutionising participants' health and wellbeing through neuro-reprogramming via the Slimpod ®  app"", 'Eighty-two overweight adults']","['audio unconscious-persuasion weight loss/weight management intervention (Slimpod ® ', 'audio relaxation (control']","['mean weight loss', 'ESES negative affect sub-scale score or ECS', 'Weight', 'self-efficacy', 'Eating Self-Efficacy Scale (ESES), Exercise Confidence Scale (ECS), and Quality of Life Index Generic Version III (QLI-G3', 'weight and increasing eating self-efficacy']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C3816958', 'cui_str': '80'}]","[{'cui': 'C0041654', 'cui_str': 'Unconscious (Psychology)'}, {'cui': 'C0031230', 'cui_str': 'Persuasion'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",82.0,0.136277,ESES scores showed greater self-efficacy ( P  = 0.008) in intervention at 24 weeks.,"[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kyle', 'Affiliation': 'School of Health and Social Care, Edinburgh Napier University.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Jones', 'Affiliation': 'Independent Statistical Consultant.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Roycroft-Davis', 'Affiliation': 'Wellpods International.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/bjgp20X711701']
2939,32554693,What predicts poor outcome after successful thrombectomy in late time windows?,"BACKGROUND


Thrombectomy for acute ischemic stroke treatment leads to improved outcomes, but many patients do not achieve a good outcome despite successful reperfusion. We determined predictors of poor outcome after successful thrombectomy (TICI 2b-3) with an emphasis on modifiable factors.
METHODS


Patients from the randomized DEFUSE 3 trial who underwent thrombectomy with TICI 2b-3 revascularization were included. Primary outcome was a poor outcome at 90 days (modified Rankin Scale score 3-6).
RESULTS


70 patients were included. Poor outcome patients were older (73.5 vs 66.5 years; P=0.01), more likely to be female (68% vs 39%; P=0.02), had higher NIHSS scores (20 vs 13; P<0.001), and had poor cerebral perfusion collaterals (hypoperfusion intensity ratio) (median 0.45 vs 0.38; P=0.03). Following thrombectomy, poor outcome patients had larger 24 hour' core infarctions (median 59.5 vs 29.9 mL; P=0.01), more core infarction growth (median 33.6 vs 13.4 mL; P<0.001), and more mild (65% vs 50%; P=0.02) and severe (18% vs 0%; P=0.01) reperfusion hemorrhage. In a logistic regression analysis, the presence of any reperfusion hemorrhage (OR 3.3 [95% CI, 1.67 to 5]; P=0.001), age (OR 1.1 [95% CI, 1.03 to 1.11], P=0.004), higher NIHSS (OR 1.25 [95% CI, 1.07 to 1.41], P=0.002), and time from imaging to femoral artery puncture (OR 5 [95% CI, 1.16 to 16.67], P=0.03) independently predicted poor outcomes.
CONCLUSIONS


In late time windows, both mild and severe reperfusion hemorrhage were associated with poor outcomes. Older age, higher NIHSS, and increased time from imaging to arterial puncture were also associated with poor outcomes despite successful revascularization.
TRIAL REGISTRATION


https://clinicaltrials.gov/ct2/show/NCT02586415.",2020,"Poor outcome patients were older (73.5 vs 66.5 years; P=0.01), more likely to be female (68% vs 39%; P=0.02), had higher NIHSS scores (20 vs 13; P<0.001), and had poor cerebral perfusion collaterals (hypoperfusion intensity ratio) (median 0.45 vs 0.38; P=0.03).","['Patients from the randomized DEFUSE 3 trial who underwent thrombectomy with TICI 2b-3 revascularization were included', '70 patients were included']",[],"['poor cerebral perfusion collaterals (hypoperfusion intensity ratio', ""larger 24\u2009hour' core infarctions"", 'poor outcome at 90\u2009days (modified Rankin Scale score 3-6', 'mild and severe reperfusion hemorrhage', 'time from imaging to femoral artery puncture', 'higher NIHSS', 'reperfusion hemorrhage', 'core infarction growth', 'NIHSS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C1275670', 'cui_str': 'Collateral branch of vessel'}, {'cui': 'C0442856', 'cui_str': 'Hypoperfusion'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}]",70.0,0.21079,"Poor outcome patients were older (73.5 vs 66.5 years; P=0.01), more likely to be female (68% vs 39%; P=0.02), had higher NIHSS scores (20 vs 13; P<0.001), and had poor cerebral perfusion collaterals (hypoperfusion intensity ratio) (median 0.45 vs 0.38; P=0.03).","[{'ForeName': 'Jeremy J', 'Initials': 'JJ', 'LastName': 'Heit', 'Affiliation': 'Department of Radiology, Stanford University, Stanford, California, USA jheit@stanford.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mlynash', 'Affiliation': 'Department of Neurology, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Soren', 'Initials': 'S', 'LastName': 'Christensen', 'Affiliation': 'Department of Neurology, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Kemp', 'Affiliation': 'Department of Neurology, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Maarten G', 'Initials': 'MG', 'LastName': 'Lansberg', 'Affiliation': 'Department of Neurology, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Marks', 'Affiliation': 'Department of Radiology, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Olivot', 'Affiliation': 'Vascular Neurology, Stroke Department, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'Albers W', 'Initials': 'AW', 'LastName': 'Gregory', 'Affiliation': 'Department of Neurology, Stanford University, Stanford, California, USA.'}]",Journal of neurointerventional surgery,['10.1136/neurintsurg-2020-016125']
2940,32554724,Feasibility randomised controlled trial of remote symptom chemotherapy toxicity monitoring using the Canadian adapted Advanced Symptom Management System (ASyMS-Can): a study protocol.,"INTRODUCTION


Technology is emerging as a solution to develop home-based, proactive 'real-time' symptom monitoring and management in cancer care. The Advanced Symptom Monitoring and Management System-Canada (ASyMS-Can) is a remote phone-based symptom management system that enables real-time remote monitoring of systemic chemotherapy toxicities.
METHODS AND ANALYSIS


This study is an open-label, prospective, mixed-method, Phase II, 2-arm parallel group assignment (ASyMS-Can vs usual care) feasibility study in patients with cancer receiving systemic (neo-adjuvant or adjuvant) chemotherapy at Princess Margaret Cancer Centre. A total of 114 patients will be recruited in oncology clinics prior to initiation of chemotherapy. Patients in both arms will complete a demographic and a set of questionnaires at enrolment, mid and end of treatment. Patients in intervention arm will be provided with an encrypted, secure, preprogrammed ASyMS phone for symptom reporting daily for the first 14 days of each chemotherapy treatment cycle up to sixth cycle (16 weeks). Feasibility metrics (recruitment, retention and protocol adherence) and outcomes to assess impact of ASyMS-Can include symptom severity, emotional distress, quality of life and acceptability to patients and clinicians.
ETHICS AND DISSEMINATION


The study has received ethical and institutional approvals from the University Health Network. Dissemination will include presentations at national/international conferences, and publications in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT03335189.",2020,"The Advanced Symptom Monitoring and Management System-Canada (ASyMS-Can) is a remote phone-based symptom management system that enables real-time remote monitoring of systemic chemotherapy toxicities.
","['114 patients will be recruited in oncology clinics prior to initiation of chemotherapy', 'patients with cancer receiving systemic (neo-adjuvant or adjuvant) chemotherapy at Princess Margaret Cancer Centre']",['remote symptom chemotherapy toxicity monitoring using the Canadian adapted Advanced Symptom Management System (ASyMS-Can'],"['symptom severity, emotional distress, quality of life and acceptability', 'Feasibility metrics (recruitment, retention and protocol adherence']","[{'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839015', 'cui_str': 'Oncology clinic'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",114.0,0.0743316,"The Advanced Symptom Monitoring and Management System-Canada (ASyMS-Can) is a remote phone-based symptom management system that enables real-time remote monitoring of systemic chemotherapy toxicities.
","[{'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Moradian', 'Affiliation': 'School of Nursing, York University Faculty of Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Krzyzanowska', 'Affiliation': 'University of Toronto Institute of Health Policy Management and Evaluation, Toronto, Ontario, Canada.'}, {'ForeName': 'Roma', 'Initials': 'R', 'LastName': 'Maguire', 'Affiliation': 'University of Strathclyde Department of Computer and Information Sciences, Glasgow, UK.'}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Kukreti', 'Affiliation': 'Division of Medical Oncology and Hematology, University of Toronto Faculty of Medicine, Toronto, Ontario, Canada.'}, {'ForeName': 'Eitan', 'Initials': 'E', 'LastName': 'Amir', 'Affiliation': 'Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Plinio P', 'Initials': 'PP', 'LastName': 'Morita', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'University Health Network and Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Howell', 'Affiliation': 'Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada doris.howell@uhn.ca.'}]",BMJ open,['10.1136/bmjopen-2019-035648']
2941,32554725,Electronic symptom monitoring in patients with metastatic lung cancer: a feasibility study.,"OBJECTIVES


To design an electronic questionnaire for symptom monitoring and to evaluate the feasibility, usability and acceptability when applied to patients with metastatic lung cancer.
SETTING


Single-centre feasibility study.
PARTICIPANTS


Patients with stage IV lung cancer in antineoplastic treatment.
INTERVENTIONS


This study describes the first three phases of a complex intervention design: phase 1, development of the intervention; phase 2, feasibility testing and phase 3, evaluation of the intervention. In phase 1, items were selected for the questionnaire and adjusted following patient interviews. In phase 2, patients completed the electronic questionnaire weekly during a 3-week feasibility test. In case of symptom deterioration, a nurse was notified with the aim to contact the patient. In phase 3, patients evaluated phase 2 by paper questionnaires, and interviews were conducted with the participating nurses.
PRIMARY OUTCOME MEASURES


The study outcomes: phase 1, usability and relevance; phase 2, recruitment rate, compliance and threshold functionality and phase 3, usability, acceptability and relevance.
RESULTS


In phase 1, a questionnaire was designed and reviewed by patients (n=8). The interviews revealed high usability and relevance of the intervention.For phases 2 and 3, 20 of 29 approached patients (69%) responded to the questionnaire on a weekly basis. Two patients did not complete any questionnaires (compliance 90%). The remaining 18 patients completed 65 of a total of 72 possible questionnaires (7 missed, 93% completed). Reported symptoms led to a phone call from a nurse in 30% of the responses.The patients reported high usability and acceptability of questionnaire and software. The substance of the telephonic conversations was relevant, and the study set-up was logistically acceptable.
CONCLUSIONS


An electronic questionnaire designed for symptom monitoring revealed high usability, acceptability and relevance in the target population. In conclusion, the study set-up was considered feasible for a randomised controlled trial.
TRIAL REGISTRATION NUMBER


NCT03529851.",2020,"For phases 2 and 3, 20 of 29 approached patients (69%) responded to the questionnaire on a weekly basis.","['patients with metastatic lung cancer', 'Patients with stage IV lung cancer in antineoplastic treatment', '18 patients completed 65 of a total of 72 possible questionnaires (7 missed, 93% completed']",['Electronic symptom monitoring'],"['usability and relevance; phase 2, recruitment rate, compliance and threshold functionality and phase 3, usability, acceptability and relevance', 'feasibility, usability and acceptability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0153676', 'cui_str': 'Secondary malignant neoplasm of lung'}, {'cui': 'C0855005', 'cui_str': 'Lung carcinoma cell type unspecified stage IV'}, {'cui': 'C0003392', 'cui_str': 'Antineoplastic agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",29.0,0.0401048,"For phases 2 and 3, 20 of 29 approached patients (69%) responded to the questionnaire on a weekly basis.","[{'ForeName': 'Rasmus Blechingberg', 'Initials': 'RB', 'LastName': 'Friis', 'Affiliation': 'Department of Oncology, Hospital Unit West Jutland, Herning, Denmark rasfri@rm.dk.'}, {'ForeName': 'Niels Henrik', 'Initials': 'NH', 'LastName': 'Hjollund', 'Affiliation': 'AmbuFlex, Occupational Medicine, University Research Clinic, Aarhus University, Hospital Unit West Jutland, Herning, Denmark.'}, {'ForeName': 'Caroline Trillingsgaard', 'Initials': 'CT', 'LastName': 'Mejdahl', 'Affiliation': 'AmbuFlex, Occupational Medicine, University Research Clinic, Aarhus University, Hospital Unit West Jutland, Herning, Denmark.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Pappot', 'Affiliation': 'Department of Oncology, University Hospital of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Halla', 'Initials': 'H', 'LastName': 'Skuladottir', 'Affiliation': 'Department of Oncology, Hospital Unit West Jutland, Herning, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-035673']
2942,32561468,Enhancing prolonged exposure therapy for PTSD among veterans with oxytocin: Design of a multisite randomized controlled trial.,"Posttraumatic stress disorder (PTSD) is the most highly prevalent mental health disorder among U.S. military Veterans. Prolonged Exposure (PE) therapy is one of the most widely used evidence-based treatments for PTSD, but there is substantial room for improvement in outcomes and retention rates. Accumulating data suggest that oxytocin offers a promising pharmacological approach towards achieving this goal. Therefore, the primary objective of this two-site Phase II study is to examine the ability of oxytocin (vs. placebo) administration combined with PE therapy to (1) reduce PTSD symptom severity, (2) accelerate the rate of PTSD symptom improvement, and (3) improve PE adherence and retention rates. To accomplish these objectives, we will employ a randomized, double-blind, placebo-controlled trial and use standardized, repeated dependent measures of change at five time points (baseline, mid-treatment, end of treatment, and 3 and 6 month follow-up). Intranasal oxytocin (40 IU) will be administered directly prior to each PE therapy session. Findings from this study will provide critical new information regarding the efficacy of oxytocin to augment psychosocial treatment for PTSD, as well as information regarding the physiological mechanisms underlying PTSD and positive treatment response. ClinicalTrials.gov Identifier: NCT04228289.",2020,"Findings from this study will provide critical new information regarding the efficacy of oxytocin to augment psychosocial treatment for PTSD, as well as information regarding the physiological mechanisms underlying PTSD and positive treatment response.","['Posttraumatic stress disorder (PTSD', 'PTSD among veterans with']","['Prolonged Exposure (PE) therapy', 'oxytocin', 'oxytocin (vs. placebo) administration combined with PE therapy', 'Intranasal oxytocin', 'placebo']","['PTSD symptom severity, (2) accelerate the rate of PTSD symptom improvement, and (3) improve PE adherence and retention rates']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",,0.421747,"Findings from this study will provide critical new information regarding the efficacy of oxytocin to augment psychosocial treatment for PTSD, as well as information regarding the physiological mechanisms underlying PTSD and positive treatment response.","[{'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: hellmuth@musc.edu.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Mitchell', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA; Department of Neurology, University of California San Francisco, San Francisco, CA, USA; San Francisco Veterans Affairs Health Care System, San Francisco, CA, USA. Electronic address: jennifer.mitchell@ucsf.edu.'}, {'ForeName': 'Nathaniel L', 'Initials': 'NL', 'LastName': 'Baker', 'Affiliation': 'Department of Public Health Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: bakern@musc.edu.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Woolley', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA; San Francisco Veterans Affairs Health Care System, San Francisco, CA, USA. Electronic address: josh.woolley@ucsf.edu.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Wangelin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: bethany.wangelin@va.gov.'}, {'ForeName': 'Sudie E', 'Initials': 'SE', 'LastName': 'Back', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: backs@musc.edu.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'McQuaid', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA; San Francisco Veterans Affairs Health Care System, San Francisco, CA, USA. Electronic address: john.mcquaid@va.gov.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Neylan', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA; Department of Neurology, University of California San Francisco, San Francisco, CA, USA; San Francisco Veterans Affairs Health Care System, San Francisco, CA, USA. Electronic address: thomas.neylan@ucsf.edu.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Woolfe', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA; San Francisco Veterans Affairs Health Care System, San Francisco, CA, USA. Electronic address: william.wolfe@ucsf.edu.'}, {'ForeName': 'Kathleen T', 'Initials': 'KT', 'LastName': 'Brady', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: bradykt@musc.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106074']
2943,32561489,Rate and Predictors of Unanticipated Surgical Evacuation in Patients with Intracerebral Hemorrhage: Post Hoc Analysis of ATACH 2 Trial.,"BACKGROUND


We performed this analysis to identify the rates, predictors and associated outcomes of unexpected neurosurgical evacuation in a multicenter randomized clinical trial, Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH)-2.
METHODS


The ATACH 2 trial determined the efficacy of antihypertensive treatment in patients with spontaneous supratentorial intracerebral hemorrhages (ICHs) with a Glasgow Coma Scale (GCS) score of ≥5 and intraparenchymal hematoma volume of < 60 cm3 on initial computed tomographic (CT) scan. We determined the proportion of ICH patients requiring unanticipated surgical evacuation and identified baseline factors associated with evacuation.
RESULTS


Among the 992 subjects analyzed, 44 (4.4%) subjects required unanticipated surgical evacuation of hematoma. The proportion of subjects with initial GCS score of 13 or less was significantly higher among those who required surgical intervention (43.2% vs 26.8%, p<0.001). In the logistics regression analysis, hematoma volume ≥ 18 cm 3  (odds ratio [OR], 4.3, 95% confidence interval [CI], 2.1-8.8) and right sided hematoma (OR, 2.8, 95% CI 1.3-5.9) were significantly associated with surgical intervention. Age, location, GCS score strata, and allocated treatment (intensive versus standard systolic blood pressure (SBP) reduction) were not associated with surgical intervention. Among the 44 patients who underwent surgical evacuation, death or disability at 3 months post randomization was seen in 32 (73%) of 44 subjects.
CONCLUSIONS


In the large cohort of ATACH-2 subjects with good grade ICH, the rates of unanticipated surgical evacuation were low and was associated with a relatively high rate of death or disability at 3 months.",2020,"In the logistics regression analysis, hematoma volume ≥ 18 cm 3  (odds ratio [OR], 4.3, 95% confidence interval [CI], 2.1-8.8) and right sided hematoma (OR, 2.8, 95% CI 1.3-5.9) were significantly associated with surgical intervention.","['44 patients who underwent', '992 subjects analyzed, 44 (4.4%) subjects required', 'patients with spontaneous supratentorial intracerebral hemorrhages (ICHs) with a Glasgow Coma Scale (GCS) score of ≥5 and intraparenchymal hematoma volume of < 60 cm3 on initial computed tomographic (CT) scan', 'Patients with Intracerebral Hemorrhage', 'Acute']",['antihypertensive treatment'],"['surgical evacuation, death or disability', 'rates of unanticipated surgical evacuation', 'Cerebral Hemorrhage', 'unanticipated surgical evacuation of hematoma', 'standard systolic blood pressure (SBP) reduction', 'right sided hematoma', 'proportion of subjects with initial GCS score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0441938', 'cui_str': 'Supratentorial'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0056610', 'cui_str': 'curium nitrate'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C1261965', 'cui_str': 'Evacuation of hematoma'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.104024,"In the logistics regression analysis, hematoma volume ≥ 18 cm 3  (odds ratio [OR], 4.3, 95% confidence interval [CI], 2.1-8.8) and right sided hematoma (OR, 2.8, 95% CI 1.3-5.9) were significantly associated with surgical intervention.","[{'ForeName': 'Adnan I', 'Initials': 'AI', 'LastName': 'Qureshi', 'Affiliation': 'Department of Neurology, University of Missouri-Columbia, MO, USA.'}, {'ForeName': 'Iryna', 'Initials': 'I', 'LastName': 'Lobanova', 'Affiliation': 'Department of Neurology, University of Missouri-Columbia, MO, USA. Electronic address: lobanovanmu@gmail.com.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'Department of Neurology, University of Missouri-Columbia, MO, USA.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Saeed', 'Affiliation': 'Department of Neurology, University of Tennessee Health Science Center.'}, {'ForeName': 'Jose I', 'Initials': 'JI', 'LastName': 'Suarez', 'Affiliation': 'Neurosciences Critical Care, Departments of Anesthesiology and Critical Care Medicine, Neurology, and Neurosurgery, Johns Hopkins University School of Medicine Baltimore, MD, USA.'}]",World neurosurgery,['10.1016/j.wneu.2020.06.089']
2944,32561505,Effect of different types of exercises on psychological and cognitive features in people with Parkinson's disease: a randomized controlled trial.,"BACKGROUND


Parkinson's disease (PD) is a neurodegenerative and progressive disease marked by the presence of motor and non-motor symptoms, as psychological and cognitive impairment. Physical exercises have been prescribed as complementary therapy for PD, and the type of intervention and duration of the intervention should be taken into account.
OBJECTIVE


We aimed to compare the effect of different exercise modalities (functional mobility, multimodal and cognitive) and length (4 and 8 months) on psychological and cognition in people with PD. This study followed the CONSORT extension for non-pharmacological trials.
METHODS


In this randomized controlled trial, we assessed 107 participants between 2011 and 2013. At the end of 3 years, participants with PD (mild to moderate stages) who achieved the criteria were assessed considering 3 different groups of exercise: Multimodal (n=38), Functional Mobility (n=33) and Mental/Leisure (n=36). All 3 interventions were performed for 32 weeks, twice a week, with 60 min for each session (64 sessions in total). Psychological and cognitive function were assessed at baseline and after 4 and 8 months.
RESULTS


The Functional Mobility and Mental/Leisure training had a potential effect on maintaining cognitive function (executive function, attention and work memory). The Multimodal training did not show a benefit for cognitive features and was not even able to delay the progressive decline in cognitive functions; however, this modality had a positive effect on physical stress after 8 months of exercise.
CONCLUSIONS


An intervention that requires high complexity and specific activities, such as locomotor and cognitive exercise, provides a maintenance effect against the degeneration in cognition associated with the progression of PD and thus can delay the progressive decline in cognitive function in PD.",2020,"The Multimodal training did not show a benefit for cognitive features and was not even able to delay the progressive decline in cognitive functions; however, this modality had a positive effect on physical stress after 8 months of exercise.
","['107 participants between 2011 and 2013', ""people with Parkinson's disease"", 'participants with PD (mild to moderate stages) who achieved the criteria were assessed considering 3 different groups of exercise: Multimodal (n=38), Functional Mobility (n=33) and Mental/Leisure (n=36', 'people with PD']","['Physical exercises', 'exercise modalities (functional mobility, multimodal and cognitive) and length (4 and 8 months', 'Multimodal training', 'exercises']","['physical stress', 'psychological and cognition', 'psychological and cognitive features', 'Psychological and cognitive function', 'maintaining cognitive function (executive function, attention and work memory']","[{'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0231302', 'cui_str': 'Physical stress'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",107.0,0.0517501,"The Multimodal training did not show a benefit for cognitive features and was not even able to delay the progressive decline in cognitive functions; however, this modality had a positive effect on physical stress after 8 months of exercise.
","[{'ForeName': 'Lilian Teresa Bucken', 'Initials': 'LTB', 'LastName': 'Gobbi', 'Affiliation': 'São Paulo State University (UNESP), Post-graduation Program in Movement Sciences, Institute of Biosciences, Posture and Gait Studies Laboratory (LEPLO), Rio Claro, Brazil. Electronic address: lilian.gobbi@unesp.br.'}, {'ForeName': 'Paulo Henrique Silva', 'Initials': 'PHS', 'LastName': 'Pelicioni', 'Affiliation': 'Neuroscience Research Australia, University of New South Wales, Sydney, Australia; School of Public Health and Community Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Lahr', 'Affiliation': 'São Paulo State University (UNESP), Post-graduation Program in Movement Sciences, Institute of Biosciences, Posture and Gait Studies Laboratory (LEPLO), Rio Claro, Brazil.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Lirani-Silva', 'Affiliation': 'São Paulo State University (UNESP), Post-graduation Program in Movement Sciences, Institute of Biosciences, Posture and Gait Studies Laboratory (LEPLO), Rio Claro, Brazil.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Teixeira-Arroyo', 'Affiliation': 'Centro Universitário UNIFAFIBE, Bebedouro, São Paulo, Brazil.'}, {'ForeName': 'Paulo Cezar Rocha Dos', 'Initials': 'PCRD', 'LastName': 'Santos', 'Affiliation': 'São Paulo State University (UNESP), Post-graduation Program in Movement Sciences, Institute of Biosciences, Posture and Gait Studies Laboratory (LEPLO), Rio Claro, Brazil; University of Groningen, University Medical Center Groningen, Center for Human Movement Sciences, Groningen, The Netherlands.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2020.05.011']
2945,32561506,"Quality of life, body image and mobility in lower-limb amputees using high-tech prostheses: a pragmatic trial.","BACKGROUND


High-tech prostheses are supposed to achieve better functional recovery over mechanical-controlled prostheses in lower-limb amputees. However, quantitative data are insufficient.
OBJECTIVE


We aimed to evaluate changes in quality of life, life satisfaction, perception of body image, and functional performance of lower-limb amputees when using a mechanical-controlled prosthesis versus a microprocessor-controlled knee (MPK) or transtibial vacuum-assisted suspension system (VASS) prosthesis.
METHODS


In this pragmatic study, 57 lower-limb amputees were assessed with the Satisfaction with the Prosthesis Questionnaire (SATPRO), revised Amputee Body Image Scale (ABIS-R), Trinity Amputation and Prosthesis Experience Scales (TAPES), Medical Outcomes Study Short Form-36 (SF-36) and 6-min walk test (6MWT). All assessments were performed under 2 conditions (i.e., using a mechanical-controlled prosthesis vs an MPK/VASS prosthesis.
RESULTS


Amputees who used an MPK/VASS prosthesis showed significant increases in all SF-36 subscale scores and all subscale scores of TAPES except adjustment to limitation (p=0.156). The amputees showed clinically relevant improvements in 6MWT (p<0.001) and in SATPRO and ABIS-R scores (p <0.001).
CONCLUSION


Lower-limb amputees using an MPK/VASS prosthesis had better life satisfaction, quality of life and functional performance than those using a mechanical-controlled prosthesis.",2020,"RESULTS


Amputees who used an MPK/VASS prosthesis showed significant increases in all SF-36 subscale scores and all subscale scores of TAPES except adjustment to limitation (p=0.156).","['57 lower-limb amputees', 'lower-limb amputees using high-tech prostheses']","['MPK/VASS prosthesis', 'mechanical-controlled prosthesis versus a microprocessor-controlled knee (MPK) or transtibial vacuum-assisted suspension system (VASS) prosthesis']","['quality of life, life satisfaction, perception of body image, and functional performance', '6MWT (p<0.001) and in SATPRO and ABIS-R scores', 'Quality of life, body image and mobility', 'life satisfaction, quality of life and functional performance', 'Satisfaction with the Prosthesis Questionnaire (SATPRO), revised Amputee Body Image Scale (ABIS-R), Trinity Amputation and Prosthesis Experience Scales', 'TAPES), Medical Outcomes Study Short Form-36 (SF-36) and 6-min walk test (6MWT', 'SF-36 subscale scores']","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0002695', 'cui_str': 'Amputee'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}]","[{'cui': 'C0026012', 'cui_str': 'Microprocessors'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0002695', 'cui_str': 'Amputee'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}]",57.0,0.0833121,"RESULTS


Amputees who used an MPK/VASS prosthesis showed significant increases in all SF-36 subscale scores and all subscale scores of TAPES except adjustment to limitation (p=0.156).","[{'ForeName': 'Burcu', 'Initials': 'B', 'LastName': 'Burçak', 'Affiliation': 'Ministry of Health, Ankara Physical Medicine and Rehabilitation Training and Research Hospital, Department of Physical Medicine and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Bilge', 'Initials': 'B', 'LastName': 'Kesikburun', 'Affiliation': 'Ministry of Health, Ankara Physical Medicine and Rehabilitation Training and Research Hospital, Department of Physical Medicine and Rehabilitation, Ankara, Turkey. Electronic address: drbilgekb@gmail.com.'}, {'ForeName': 'Belma Füsun', 'Initials': 'BF', 'LastName': 'Köseoğlu', 'Affiliation': 'Ministry of Health, Ankara Physical Medicine and Rehabilitation Training and Research Hospital, Department of Physical Medicine and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Öznur', 'Initials': 'Ö', 'LastName': 'Öken', 'Affiliation': 'Ministry of Health, Ankara Physical Medicine and Rehabilitation Training and Research Hospital, Department of Physical Medicine and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Asuman', 'Initials': 'A', 'LastName': 'Doğan', 'Affiliation': 'Ministry of Health, Ankara Physical Medicine and Rehabilitation Training and Research Hospital, Department of Physical Medicine and Rehabilitation, Ankara, Turkey.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2020.03.016']
2946,32561673,Ketamine Affects Prediction Errors about Statistical Regularities: A Computational Single-Trial Analysis of the Mismatch Negativity.,"The auditory mismatch negativity (MMN) is significantly reduced in schizophrenia. Notably, a similar MMN reduction can be achieved with NMDA receptor (NMDAR) antagonists. Both phenomena have been interpreted as reflecting an impairment of predictive coding or, more generally, the ""Bayesian brain"" notion that the brain continuously updates a hierarchical model to infer the causes of its sensory inputs. Specifically, neurobiological interpretations of predictive coding view perceptual inference as an NMDAR-dependent process of minimizing hierarchical precision-weighted prediction errors (PEs), and disturbances of this putative process play a key role in hierarchical Bayesian theories of schizophrenia. Here, we provide empirical evidence for this theory, demonstrating the existence of multiple, hierarchically related PEs in a ""roving MMN"" paradigm.We applied a hierarchical Bayesian model to single-trial EEG data from healthy human volunteers of either sex who received the NMDAR antagonist S-ketamine in a placebo-controlled, double-blind, within-subject fashion. Using an unrestricted analysis of the entire time-sensor space, our trial-by-trial analysis indicated that low-level PEs (about stimulus transitions) are expressed early (102-207ms post-stimulus), while high-level PEs (about transition probability) are reflected by later components (152-199ms, 215-277ms) of single-trial responses. Furthermore, we find that ketamine significantly diminished the expression of high-level PE responses, implying that NMDAR antagonism disrupts inference on abstract statistical regularities.Our findings suggest that NMDAR dysfunction impairs hierarchical Bayesian inference about the world's statistical structure. Beyond the relevance of this finding for schizophrenia, our results illustrate the potential of computational single-trial analyses for assessing potential pathophysiological mechanisms. Significance Statement The NMDA receptor antagonist ketamine induces psychosis-like experiences in healthy individuals, consistent with the notion that the pathophysiology of schizophrenia involves NMDAR dysfunction. On the cognitive level, the stark misrepresentations of reality during psychosis suggest a dysfunction at high levels of belief hierarchies, where general and stable features of the environment are represented. Here, we investigate physiological indices of altered perception under ketamine - the reduction of the auditory ""mismatch negativity"" - based on their algorithmic interpretation as hierarchical belief updates. We find that ketamine indeed impacts cortical signaling of higher-level belief updates about environmental volatility. This finding bridges physiological and computational concepts of NMDAR dysfunction and offers a novel mechanistic perspective on a central element of pathophysiological theories of schizophrenia.",2020,The auditory mismatch negativity (MMN) is significantly reduced in schizophrenia.,"['healthy human volunteers of either sex who received the', 'healthy individuals']","['NMDAR antagonist S-ketamine', 'NMDA receptor antagonist ketamine', 'ketamine', 'Ketamine']","['auditory mismatch negativity (MMN', 'expression of high-level PE responses']","[{'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0598695', 'cui_str': 'NMDA receptor antagonist'}, {'cui': 'C2825616', 'cui_str': 'esketamine'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0393847', 'cui_str': 'Motor neuropathy with multiple conduction block'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0856175,The auditory mismatch negativity (MMN) is significantly reduced in schizophrenia.,"[{'ForeName': 'Lilian A', 'Initials': 'LA', 'LastName': 'Weber', 'Affiliation': 'Translational Neuromodeling Unit (TNU), Institute for Biomedical Engineering, University of Zurich and ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Andreea O', 'Initials': 'AO', 'LastName': 'Diaconescu', 'Affiliation': 'Translational Neuromodeling Unit (TNU), Institute for Biomedical Engineering, University of Zurich and ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Mathys', 'Affiliation': 'Interacting Minds Centre, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Schmidt', 'Affiliation': 'Department of Psychiatry, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kometer', 'Affiliation': 'Neuropharmacology and Brain Imaging, University Hospital of Psychiatry, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Vollenweider', 'Affiliation': 'Neuropharmacology and Brain Imaging, University Hospital of Psychiatry, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Klaas E', 'Initials': 'KE', 'LastName': 'Stephan', 'Affiliation': 'Translational Neuromodeling Unit (TNU), Institute for Biomedical Engineering, University of Zurich and ETH Zurich, Zurich, Switzerland.'}]",The Journal of neuroscience : the official journal of the Society for Neuroscience,['10.1523/JNEUROSCI.3069-19.2020']
2947,32561824,Semaphorin 3 C is a Novel Adipokine Representing Exercise-Induced Improvements of Metabolism in Metabolically Healthy Obese Young Males.,"This study investigated the endurance exercise-induced changes in lesser known adipokines (visfatin, chemerin, apelin, semaphorin 3 C) related to obesity and metabolism, and their correlations with the changes in the parameters of obesity and glucose homeostasis. Forty metabolically healthy obese young males were randomly assigned to control group (C, n = 12) or exercise group (Ex, n = 28). The subjects in Ex participated in a 8-week supervised endurance exercise training program, comprised of four sessions of treadmill running at 65-70% of VO 2max  per week. Serum levels of visfatin, chemerin, apelin, and semaphorin 3 C were significantly decreased in Ex. At baseline, apelin and semaphorin 3 C appeared to be correlated with obesity measures, including body mass index, % total fat and trunk fat, and waist circumference. Exercise-induced changes in these obesity measures significantly correlated with the changes in chemerin and semaphorin 3 C. Basal chemerin, apelin and semaphorin 3 C correlated with glucose homeostasis parameters, including fasting plasma glucose, fasting plasma insulin, homeostasis model assessment of insulin resistance and β-cell function, and quantitative insulin-sensitivity check index to different extents. Furthermore, the changes in apelin and semaphorin 3 C well predicted the improvements in glycemic parameters. We suggest that semaphorin 3 C is a novel adipokine involved in pathophysiology of obesity and metabolism, and that it is a biomarker representing an exercise-induced improvement in metabolically healthy obese young males.",2020,"Serum levels of visfatin, chemerin, apelin, and semaphorin 3 C were significantly decreased in Ex.","['Metabolically Healthy Obese Young Males', 'Forty metabolically healthy obese young males', 'metabolically healthy obese young males']","['supervised endurance exercise training program', 'control group (C, n\u2009=\u200912) or exercise']","['glycemic parameters', 'fasting plasma glucose, fasting plasma insulin, homeostasis model assessment of insulin resistance and β-cell function, and quantitative insulin-sensitivity check index', 'Serum levels of visfatin, chemerin, apelin, and semaphorin 3\u2009C', 'body mass index, % total fat and trunk fat, and waist circumference']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0068707', 'cui_str': 'Nicotinamide phosphoribosyltransferase'}, {'cui': 'C3542402', 'cui_str': 'Apelin'}, {'cui': 'C1136368', 'cui_str': 'Semaphorin-3'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439175', 'cui_str': '% of total'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}]",40.0,0.0146105,"Serum levels of visfatin, chemerin, apelin, and semaphorin 3 C were significantly decreased in Ex.","[{'ForeName': 'Ji Sun', 'Initials': 'JS', 'LastName': 'Nam', 'Affiliation': 'Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Chul Woo', 'Initials': 'CW', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hye Jun', 'Initials': 'HJ', 'LastName': 'Park', 'Affiliation': 'Graduate School of Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Yu Sik', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'Severance Institute for Vascular and Metabolic Research, Yonsei University College of Medicine, Seoul, Korea. cromoton@yuhs.ac.'}]",Scientific reports,['10.1038/s41598-020-67004-7']
2948,32561877,Effect of 9-month Pilates program on sagittal spinal curvatures and hamstring extensibility in adolescents: randomised controlled trial.,"The percentage of spine misalignment increases during the childhood and adolescence stages. The Pilates method has been associated with an improvement in the sagittal spine disposition, but no studies have been conducted on adolescents. Therefore, the present study aimed to evaluate the effectiveness of a 9-month Pilates exercise program (PEP) on hamstring extensibility and sagittal spinal curvatures on adolescents. This randomised controlled trial included 236 adolescents. The experimental group (EG) received a PEP (9 months, 2 sessions/week, 15 minutes/session). The control group (CG) did not receive any intervention. Hamstring extensibility was measured with the passive and active straight leg raise and toe-touch tests. Sagittal spinal curvatures and pelvic tilt was assessed in relaxed standing, active alignment and toe-touch test positions. The EG had significant changes in hamstring extensibility, lumbar curvature and pelvic tilt in standing sagittal curvature. The CG became significantly worse in thoracic kyphosis in standing. This study provides evidence of nine-months of a PEP increased the hamstring extensibility; averted the increase of the thoracic curvature, and decreased the curvature of the lumbar lordosis and pelvic tilt in standing position; avoided a greater increase of thoracic curvature in active alignment in standing position; and avoided the increase of thoracic curvature in trunk flexion.",2020,"The EG had significant changes in hamstring extensibility, lumbar curvature and pelvic tilt in standing sagittal curvature.","['hamstring extensibility and sagittal spinal curvatures on adolescents', '236 adolescents', 'adolescents']","['PEP', 'Pilates program', 'Pilates exercise program (PEP']","['Sagittal spinal curvatures and pelvic tilt', 'percentage of spine misalignment', 'Hamstring extensibility', 'hamstring extensibility, lumbar curvature and pelvic tilt in standing sagittal curvature', 'thoracic curvature', 'hamstring extensibility', 'sagittal spinal curvatures and hamstring extensibility']","[{'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0037932', 'cui_str': 'Curvature of spine'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C1321049', 'cui_str': 'Pilates exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0037932', 'cui_str': 'Curvature of spine'}, {'cui': 'C1629036', 'cui_str': 'Pelvic declination'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C1275957', 'cui_str': 'Misalignment'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}]",236.0,0.0207577,"The EG had significant changes in hamstring extensibility, lumbar curvature and pelvic tilt in standing sagittal curvature.","[{'ForeName': 'Noelia', 'Initials': 'N', 'LastName': 'González-Gálvez', 'Affiliation': 'Research Group on Health, Physical Activity, Fitness and Motor Behaviour (GISAFFCOM), Catholic University of San Antonio of Murcia (UCAM), Murcia, Spain.'}, {'ForeName': 'Pablo Jorge', 'Initials': 'PJ', 'LastName': 'Marcos-Pardo', 'Affiliation': 'Research Group on Health, Physical Activity, Fitness and Motor Behaviour (GISAFFCOM), Catholic University of San Antonio of Murcia (UCAM), Murcia, Spain. pmarcos@ucam.edu.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Trejo-Alfaro', 'Affiliation': 'Research Group on Health, Physical Activity, Fitness and Motor Behaviour (GISAFFCOM), Catholic University of San Antonio of Murcia (UCAM), Murcia, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Vaquero-Cristóbal', 'Affiliation': 'Research Group on Prevention of Lesions in Sports, Catholic University of San Antonio of Murcia (UCAM), Murcia, Spain.'}]",Scientific reports,['10.1038/s41598-020-66641-2']
2949,32555025,An Intervention for Mental Health Literacy and Resilience in Organized Sports.,"PURPOSE


In this study we tested the effectiveness of a multi-component sports-based program aimed at promoting early intervention, help-seeking and resilience among a sample of adolescent male sport participants.
METHODS


The Ahead of the Game program comprised four intervention components and a messaging campaign. Two components targeted mental health literacy, intentions to seek and provide help, and resilience among adolescent males. A mental health literacy program for parents, and a coach education program to assist in the support of athletes' psychological needs were also included. We evaluated the program using a non-randomised controlled trial matching two regional communities. In total, 350 sport participants (M = 14.53 years) were included in an intervention group, while 466 (M = 14.66 years) received usual practice in a matched control community. One hundred and eighty parents or caregivers and eight coaches also participated in the intervention components. Between-group mean differences on the primary and secondary outcomes were analysed using linear mixed models, adjusted for clustering at club level, participant age, and socioeconomic status.
RESULTS


Significant positive group by time interactions were found for the primary outcomes of depression and anxiety literacy, intentions to seek help from formal sources, confidence to seek mental health information, and resilience. We also found a significant positive group by time interaction for the secondary outcome of wellbeing. There were no group by time interactions for social distance (stigma), intentions to seek help from informal sources, implicit beliefs about adversity, perceived familial support, or psychological distress.
CONCLUSION


Given the high rates of sport participation worldwide and the increasing focus on mental health in this domain, translation and dissemination of the program may be warranted following replication.",2020,"RESULTS


Significant positive group by time interactions were found for the primary outcomes of depression and anxiety literacy, intentions to seek help from formal sources, confidence to seek mental health information, and resilience.","['One hundred and eighty parents or caregivers and eight coaches also participated in the intervention components', 'adolescent male sport participants', 'adolescent males', '350 sport participants (M = 14.53 years) were included in an intervention group, while 466 (M = 14.66 years) received']","['multi-component sports-based program aimed at promoting early intervention', 'usual practice in a matched control community']","['time interactions for social distance (stigma), intentions to seek help from informal sources, implicit beliefs about adversity, perceived familial support, or psychological distress', 'depression and anxiety literacy, intentions to seek help from formal sources, confidence to seek mental health information, and resilience', 'linear mixed models, adjusted for clustering at club level, participant age, and socioeconomic status']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0037412', 'cui_str': 'Social Distance'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}]",350.0,0.052409,"RESULTS


Significant positive group by time interactions were found for the primary outcomes of depression and anxiety literacy, intentions to seek help from formal sources, confidence to seek mental health information, and resilience.","[{'ForeName': 'Stewart A', 'Initials': 'SA', 'LastName': 'Vella', 'Affiliation': 'School of Psychology, Faculty of Social Sciences, University of Wollongong, Northfields Avenue, Wollongong, Australia.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Swann', 'Affiliation': 'School of Health and Human Sciences, Southern Cross University, Coffs Harbour, Australia.'}, {'ForeName': 'Marijka', 'Initials': 'M', 'LastName': 'Batterham', 'Affiliation': 'School of Mathematics and Applied Statistics, Faculty of Engineering and Information Sciences, University of Wollongong, Wollongong, Australia.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Boydell', 'Affiliation': 'Black Dog Institute, University of New South Wales, Randwick, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Eckermann', 'Affiliation': 'Australian Health Services Research Institute, Sydney Business School, Faculty of Business, University of Wollongong, Northfields Avenue, Wollongong, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Ferguson', 'Affiliation': 'English Institute of Sport, The High Performance Centre, Bisham Abbey National Sports Centre, Bisham, Buckinghamshire, United Kingdom.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Fogarty', 'Affiliation': 'Black Dog Institute, University of New South Wales, Hospital Road, Randwick, Australia.'}, {'ForeName': 'Diarmuid', 'Initials': 'D', 'LastName': 'Hurley', 'Affiliation': 'School of Psychology, Faculty of Social Sciences, University of Wollongong, Northfields Avenue, Wollongong, Australia.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Liddle', 'Affiliation': 'School of Psychology, Faculty of Social Sciences, University of Wollongong, Wollongong, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Lonsdale', 'Affiliation': 'Institute for Positive Psychology and Education, Faculty of Health Sciences, Australian Catholic University, North Sydney, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Miller', 'Affiliation': 'School of Education, University of Newcastle, Callaghan NSW, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Noetel', 'Affiliation': 'Institute for Positive Psychology and Education, Faculty of Health Sciences, Australian Catholic University, North Sydney, Australia.'}, {'ForeName': 'Anthony D', 'Initials': 'AD', 'LastName': 'Okely', 'Affiliation': 'Early Start, Faculty of Social Sciences, University of Wollongong, Wollongong, Australia.'}, {'ForeName': 'Taren', 'Initials': 'T', 'LastName': 'Sanders', 'Affiliation': 'Institute for Positive Psychology and Education, Faculty of Health Sciences, Australian Catholic University, North Sydney, Australia.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Schweickle', 'Affiliation': 'School of Psychology, Faculty of Social Sciences, University of Wollongong, Wollongong, Australia.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Telenta', 'Affiliation': ""Centre for Health and Social Research, St. Patrick's Campus, Melbourne, Australia.""}, {'ForeName': 'Frank P', 'Initials': 'FP', 'LastName': 'Deane', 'Affiliation': 'Illawarra Institute for Mental Health, School of Psychology, Faculty of Social Sciences, University of Wollongong, Northfields Avenue, Wollongong, Australia.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002433']
2950,32555026,High-Intensity Shoulder Abduction Exercise in Subacromial Pain Syndrome.,"Subacromial pain syndrome (SAPS) defined as pain of non-traumatic origin localized around the acromion, is a debilitating, common and often chronic condition. Among many proposed underlying causes of SAPS, hypoperfusion and hypoxic conditions in and around the tendons may be an intrinsic cause of SAPS.
PURPOSE


To determine if adding high intensity aerobic interval training (HIIT) of the rotator cuff to usual care was feasible in SAPS, and improved shoulder endurance more than usual care alone. Additionally, to examine the influence on shoulder pain and disability and the response of tendinous microcirculation following HIIT.
METHODS


21 subjects with chronic SAPS were randomized to two groups: Experimental group (EG,n=13) receiving HIIT in addition to treatment as usual, and control group (CG,n=8) receiving treatment as usual. Before and after 8 weeks of exercise therapy, endurance performance was assessed by an incremental abduction exercise of the arm to exhaustion (TTE). Pain and disability was assessed by the shoulder pain and disability index (SPADI). Contrast enhanced ultrasound (CEUS) of the m.supraspinatus and tendon was utilized to indicate tendon blood flow.
RESULTS


Endurance in the TTE-test improved by an estimated 233 seconds more on average in EG than in CG (p=0.001, 95%CI:102to363) (p<0.001). The SPADI score was reduced 22 points more on average in EG (p=0.017, 95%CI:-40to-5). The change from pre to post-test was significant in EG for both TTE-test and SPADI improvement (p<0.001). EG also experienced less pain during exercise after the intervention compared to CG (p<0.001). CEUS indicated an increase in tendinous blood flow in EG (p=0.019).
CONCLUSION


HIIT rotator cuff exercise appear to be a feasible intervention in SAPS, increasing endurance performance more than usual care alone.",2020,"The SPADI score was reduced 22 points more on average in EG (p=0.017, 95%CI:-40to-5).","['Subacromial Pain Syndrome', 'Subacromial pain syndrome (SAPS', '21 subjects with chronic SAPS']","['exercise therapy, endurance performance was assessed by an incremental abduction exercise of the arm to exhaustion (TTE', 'HIIT in addition to treatment as usual, and control group (CG,n=8) receiving treatment as usual', 'CEUS', 'high intensity aerobic interval training (HIIT) of the rotator cuff to usual care', 'High-Intensity Shoulder Abduction Exercise', 'Contrast enhanced ultrasound (CEUS', 'HIIT rotator cuff exercise']","['shoulder pain and disability index (SPADI', 'SPADI score', 'Pain and disability', 'shoulder pain and disability', 'pain', 'tendinous blood flow']","[{'cui': 'C4728045', 'cui_str': 'Subacromial pain syndrome'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}]","[{'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}]",21.0,0.0806649,"The SPADI score was reduced 22 points more on average in EG (p=0.017, 95%CI:-40to-5).","[{'ForeName': 'Ole Kristian', 'Initials': 'OK', 'LastName': 'Berg', 'Affiliation': 'Faculty of Health and Social Sciences, Molde University College, Molde, Norway.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Paulsberg', 'Affiliation': 'Rosenborg Clinic of Physiotherapy, Trondheim, Norway.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Brabant', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Keyvan', 'Initials': 'K', 'LastName': 'Arabsolghar', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Sigrid', 'Initials': 'S', 'LastName': 'Ronglan', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Bjørnsen', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Tørhaug', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Granviken', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Sigmund', 'Initials': 'S', 'LastName': 'Gismervik', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hoff', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002436']
2951,32555027,Effects of Land- vs Water-Walking Interventions on Vascular Function in Older Adults.,"PURPOSE


Endothelial dysfunction is an early and integral atherogenic event. Interventions that improve endothelial function also reduce cardiovascular risk. Due largely to the direct hemodynamic effects of repetitive exercise on the artery wall, exercise training has shown to enhance endothelial function. Land-walking (LW) and water-walking (WW) induce distinct hemodynamic responses, so comparison of their impacts provides an approach to study shear stress effects on endothelial function. We hypothesized that LW and WW training would have different impacts on peripheral artery endothelial function.
METHODS


Fifty-one sedentary, older (age 61.9 ± 6.6 yrs, 23.5% male) individuals were randomized into 1 of 3 groups: control (CG, n=16), or one of two exercise groups consisting of 3 x 50 min supervised and individually tailored walking sessions per week for 24 consecutive weeks, performed either on land (LW, n=17) or in water (WW, n=18). Brachial artery endothelial function (flow mediated dilation FMD) and smooth muscle cell function (glyceryl trinitrate GTN administration) was tested in all participants before (Week 0) and after (Week 24) the intervention.
RESULTS


Differences were apparent in FMD change between the LW (Week 0: 5.39 ± 0.71% to Week 24: 7.77 ± 0.78%, P = 0.009) vs CG (Week 0: 5.87 ± 0.73% to Week 24: 5.78 ± 0.78%) groups. No differences in artery dilation response were found following GTN administration (all P >0.05).
CONCLUSION


This study suggests that 6 month centre-based LW may be superior to WW in terms of improvement in arterial endothelial function in older sedentary individuals.",2020,"No differences in artery dilation response were found following GTN administration (all P >0.05).
","['sedentary, older (age 61.9 ± 6.6 yrs, 23.5% male) individuals', 'older sedentary individuals', 'Older Adults', 'Fifty-one']","['LW and WW training', 'glyceryl trinitrate GTN administration', 'GTN', 'repetitive exercise', 'exercise groups consisting of 3 x 50 min supervised and individually tailored walking sessions', 'Land- vs Water-Walking Interventions', 'Land-walking (LW) and water-walking (WW']","['endothelial function', 'cardiovascular risk', 'Vascular Function', 'artery dilation response', 'Brachial artery endothelial function (flow mediated dilation FMD) and smooth muscle cell function ', 'peripheral artery endothelial function', 'FMD change', 'arterial endothelial function']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517823', 'cui_str': '6.6'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0078589', 'cui_str': 'X 50'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C1135918', 'cui_str': 'Smooth Muscle Cells'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",51.0,0.0163905,"No differences in artery dilation response were found following GTN administration (all P >0.05).
","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Haynes', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Louise H', 'Initials': 'LH', 'LastName': 'Naylor', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Angela L', 'Initials': 'AL', 'LastName': 'Spence', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Robey', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Kay L', 'Initials': 'KL', 'LastName': 'Cox', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Maslen', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Nicola T', 'Initials': 'NT', 'LastName': 'Lautenschlager', 'Affiliation': ''}, {'ForeName': 'Howard H', 'Initials': 'HH', 'LastName': 'Carter', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Philip N', 'Initials': 'PN', 'LastName': 'Ainslie', 'Affiliation': 'Centre for Heart, Lund and Vascular Health, School of Health and Exercise Science, University of British Columbia, Kelowna, British Columbia, Canada.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Green', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA, Australia.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002439']
2952,32555029,The Effects of L-Carnitine on Echocardiographic Changes in Patients With β-Thalassemia Major and Intermedia.,"INTRODUCTION


Heart failure, fatal arrhythmias, and cardiac dilatation because of anemia are common causes of β-thalassemia major-related deaths. The aim of this study was to determine the effect of L-carnitine on echocardiographic changes in β-thalassemia major and intermedia patients in Besat Hospital in Sanandaj, Iran.
METHODS


In a randomized clinical trial, 60 β-thalassemia patients who were eligible for L-carnitine administration were randomly divided into 2 placebo and study drug groups. The duration of the study was 6 months. Using echocardiography and blood tests, cardiac parameters including left ventricular dilatation, left ventricular hypertrophy, and a number of cardiac blood indices were examined before and after the intervention. The data were analyzed using SPSS V.23 software, χ, and covariance statistical tests.
RESULTS


There was no significant difference between the 2 groups in terms of age and sex. Patients treated with L-carnitine have a reduced rate of left ventricular dilatation, left ventricular hypertrophy, and systolic blood pressure compared with controls (P<0.05). Cardiac output increased from 43.5 to 56.5 (P=0.002).
CONCLUSIONS


The results of this study showed that the drug has a positive effect on the improvement of cardiac indices in β-thalassemia patients. Therefore, we suggest that further studies with more samples and other diagnostic modalities of the drug's effect be investigated.",2020,"Cardiac output increased from 43.5 to 56.5 (P=0.002).
","['Patients With β-Thalassemia Major and Intermedia', '60 β-thalassemia patients who were eligible for L-carnitine administration', 'β-thalassemia major and intermedia patients in Besat Hospital in Sanandaj, Iran.\nMETHODS', 'β-thalassemia patients']","['placebo', 'L-Carnitine', 'L-carnitine']","['echocardiography and blood tests, cardiac parameters including left ventricular dilatation, left ventricular hypertrophy, and a number of cardiac blood indices', 'Cardiac output', 'rate of left ventricular dilatation, left ventricular hypertrophy, and systolic blood pressure', 'cardiac indices', 'Echocardiographic Changes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002875', 'cui_str': 'Homozygous beta thalassemia'}, {'cui': 'C0446035', 'cui_str': 'Candida intermedia'}, {'cui': 'C0039730', 'cui_str': 'Thalassemia'}, {'cui': 'C0087163', 'cui_str': 'Levocarnitine'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0087163', 'cui_str': 'Levocarnitine'}]","[{'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0344911', 'cui_str': 'Left cardiac ventricular dilatation'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0340279', 'cui_str': 'Ventricular hypertrophy'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0264733', 'cui_str': 'Cardiac ventricular dilatation'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",60.0,0.0649836,"Cardiac output increased from 43.5 to 56.5 (P=0.002).
","[{'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Shahidi', 'Affiliation': 'Department of Cardiology, Besat Hospital.'}, {'ForeName': 'Sayedeh Rozhin', 'Initials': 'SR', 'LastName': 'Hashemi', 'Affiliation': 'Faculty of Medicine.'}, {'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Fattahi', 'Affiliation': 'Non-Communicable Diseases Research Center, Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Daem', 'Initials': 'D', 'LastName': 'Roshani', 'Affiliation': 'Social Determinants of Health Research Center, Research Institute for Health Development.'}, {'ForeName': 'Siamak', 'Initials': 'S', 'LastName': 'Vahedi', 'Affiliation': 'Cardiology Department.'}, {'ForeName': 'Pezhman', 'Initials': 'P', 'LastName': 'Sharifi', 'Affiliation': 'Liver and Digestive Research Center.'}, {'ForeName': 'Borhan', 'Initials': 'B', 'LastName': 'Moradveisi', 'Affiliation': 'Cancer and Immunology Research Center, Kurdistan University of Medical Sciences, Sanandaj.'}]",Journal of pediatric hematology/oncology,['10.1097/MPH.0000000000001850']
2953,32555036,"Cement Remains the Standard: Commentary on an article by Nils Oscar Nivbrant, MBBS, et al.: ""Cementless Versus Cemented Tibial Fixation in Posterior Stabilized Total Knee Replacement. A Randomized Trial"".",,2020,,['Posterior Stabilized Total Knee Replacement'],['Cementless Versus Cemented Tibial Fixation'],[],"[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]",[],,0.032418,,"[{'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Lack', 'Affiliation': 'Department of Orthopaedics and Sports Medicine, University of Washington, Seattle, Washington.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.20.00322']
2954,32555047,"Effect of NSAID Use on Bone Healing in Pediatric Fractures: A Preliminary, Prospective, Randomized, Blinded Study.","BACKGROUND


This study aimed to investigate if nonsteroidal anti-inflammatory drugs (NSAIDs) used in the acute phase of bone healing in children with fractures result in delayed union or nonunion as compared with patients who do not take NSAIDs for pain control during this same time period.
METHODS


In this prospective, randomized, parallel, single-blinded study, skeletally immature patients with long bone fractures were randomized to 1 of 2 groups for their postfracture pain management. The NSAID group was prescribed weight-based ibuprofen, whereas the control group was not allowed any NSAID medication and instead prescribed weight-based acetaminophen. Both groups were allowed to use oxycodone for breakthrough pain. The primary outcome was fracture healing assessed at 2, 6, and 10 weeks.
RESULTS


One-hundred-two patients were enrolled between February 6, 2014 and September 23, 2016. Ninety-five patients (with 97 fractures) completed a 6-month follow-up (46 patients with 47 fractures in the control group and 49 patients 50 fractures in the NSAID group). None achieved healing at 1 to 2 weeks. By 6 weeks, 37 of 45 patients (82%) of control group and 46 out of 50 patients (92%) of ibuprofen group had healed fractures (P=0.22). At 10 to 12 week follow-up, 46 (98%) of the control group fractures were healed and 50 (100%) of the ibuprofen group fractures were healed. All were healed by 6 months. Healing was documented at a mean of 40 days in the control group and 31 days in the ibuprofen group (P=0.76). The mean number of days breakthrough oxycodone was used was 2.4 days in the control group and 1.9 days in the NSAID group (P=0.48).
CONCLUSION


Ibuprofen is an effective medication for fracture pain in children and its use does not impair clinical or radiographic long bone fracture healing in skeletally immature patients.
LEVEL OF EVIDENCE


Level I-therapeutic.",2020,Healing was documented at a mean of 40 days in the control group and 31 days in the ibuprofen group (P=0.76).,"['One-hundred-two patients were enrolled between February 6, 2014 and September 23, 2016', 'skeletally immature patients', 'Pediatric Fractures', 'Ninety-five patients (with 97 fractures) completed a 6-month follow-up (46 patients with 47 fractures in the control group and 49 patients 50 fractures in the NSAID group', 'skeletally immature patients with long bone fractures', 'children with fractures result in delayed union or nonunion as compared with patients who do not take NSAIDs for pain control during this same time period']","['NSAID', 'nonsteroidal anti-inflammatory drugs (NSAIDs', 'Ibuprofen', 'oxycodone', 'ibuprofen', 'acetaminophen']","['healing', 'healed fractures', 'Bone Healing', 'fracture healing', 'mean number of days breakthrough oxycodone', 'Healing']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205252', 'cui_str': 'Immature'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0222647', 'cui_str': 'Structure of long bone'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}]","[{'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0152231', 'cui_str': 'Fracture, healed'}, {'cui': 'C1321023', 'cui_str': 'Bone healing status'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444503', 'cui_str': 'Breakthrough'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}]",102.0,0.0423132,Healing was documented at a mean of 40 days in the control group and 31 days in the ibuprofen group (P=0.76).,"[{'ForeName': 'Julia A V', 'Initials': 'JAV', 'LastName': 'Nuelle', 'Affiliation': 'Department of Orthopaedic Surgery, University of Missouri Health System, Columbia, MO.'}, {'ForeName': 'Kelsie M', 'Initials': 'KM', 'LastName': 'Coe', 'Affiliation': ''}, {'ForeName': 'Harvey A', 'Initials': 'HA', 'LastName': 'Oliver', 'Affiliation': ''}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Cook', 'Affiliation': ''}, {'ForeName': 'Daniel G', 'Initials': 'DG', 'LastName': 'Hoernschemeyer', 'Affiliation': ''}, {'ForeName': 'Sumit K', 'Initials': 'SK', 'LastName': 'Gupta', 'Affiliation': ''}]",Journal of pediatric orthopedics,['10.1097/BPO.0000000000001603']
2955,32555067,Laparoscopic Total Extraperitoneal Inguinal Hernia Repair Under Epidural Anesthesia Versus General Anesthesia.,"INTRODUCTION


Laparoscopic total extraperitoneal (TEP) inguinal hernia repair is a well-known approach to inguinal hernia repair. The present study aims to compare the advantages and disadvantages of the TEP technique under general anesthesia (GA) and epidural anesthesia (EA).
MATERIALS AND METHODS


The patients were divided into 2 groups as those undergoing TEP under EA (Group 1) and those undergoing TEP under GA (Group 2). The 2 patient groups were compared in terms of sex, age, body mass index data, duration of surgery, total operation time, patient satisfaction, VAS scores (1, 4, 12, and 24 h), length of hospital stay, and postoperative complications.
RESULTS


The number of patients operated under EA (Group 1) was 30, and the number of patients operated under GA (Group 2) was 32. Only in the postoperative first hour VAS scores was statistically significantly less and the need for analgesia evaluated in both groups was found to be statistically significantly lower in Group 1 (P<0.001). The mean operation time was recorded as 62 and 46.50 minutes in Groups 1 and 2, respectively, which was statistically significantly shorter in Group 2 (P<0.001). There was no difference between the 2 groups regarding complications, hospital stay, recovery, or surgery time. Conversion rate is 0 in both groups.
CONCLUSIONS


Lower postoperative VAS scores and lower postoperative VAS scores and lower analgesic used requirements of EA, it is thought that EA can be safely applied in the TEP procedure as an alternative in patients who cannot be administered GA.",2020,Only in the postoperative first hour VAS scores was statistically significantly less and the need for analgesia evaluated in both groups was found to be statistically significantly lower in Group 1 (P<0.001).,['patients who cannot be administered GA'],"['Epidural Anesthesia Versus General Anesthesia', 'TEP under GA', 'Laparoscopic total extraperitoneal ', 'TEP technique under general anesthesia (GA) and epidural anesthesia (EA', 'Laparoscopic Total Extraperitoneal Inguinal Hernia Repair', 'TEP under EA']","['postoperative VAS scores and lower postoperative VAS scores', 'body mass index data, duration of surgery, total operation time, patient satisfaction, VAS scores', 'complications, hospital stay, recovery, or surgery time', 'Conversion rate', 'length of hospital stay, and postoperative complications', 'need for analgesia', 'postoperative first hour VAS scores', 'mean operation time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0442090', 'cui_str': 'Extraperitoneal'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0373588,Only in the postoperative first hour VAS scores was statistically significantly less and the need for analgesia evaluated in both groups was found to be statistically significantly lower in Group 1 (P<0.001).,"[{'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Sürek', 'Affiliation': 'General Surgery Department, Bakirköy Dr. Sadi Konuk Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Mehmet Abdussamet', 'Initials': 'MA', 'LastName': 'Bozkurt', 'Affiliation': ''}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Ferahman', 'Affiliation': ''}, {'ForeName': 'Eyüp', 'Initials': 'E', 'LastName': 'Gemici', 'Affiliation': ''}, {'ForeName': 'Turgut', 'Initials': 'T', 'LastName': 'Dönmez', 'Affiliation': ''}]","Surgical laparoscopy, endoscopy & percutaneous techniques",['10.1097/SLE.0000000000000817']
2956,32555148,Effect of bolus enteral tube feeding on body weight in ambulatory adults with obesity and type 2 diabetes: a feasibility pilot randomized trial.,"BACKGROUND/OBJECTIVES


To ascertain the effect on body weight of 14 days of bolus enteral feeding with mixed meal (MM) and electrolyte solution (ES) in ambulatory adults with type 2 diabetes and obesity, and also the safety and feasibility of using a modified, intraorally anchored enteral feeding tube for this purpose.
SUBJECTS/METHODS


We conducted a randomized, crossover pilot trial with 16 participants. A 140 cm, 8-French feeding tube was placed in the jejunum under electromagnetic guidance and anchored intraorally. Participants were randomized to self-administer 120 mL 523 kJ (125 kcal) MM, or 50 kJ (12 kcal) ES four times/day for 14 days. After ≥14 days without the tube, participants crossed over to the other treatment. The primary outcome compared weight change between treatments. Thereafter, participants could elect to undergo additional MM cycles. Participants were encouraged to continue with all usual activities including eating ad lib throughout the study.
RESULTS


Ten participants withdrew prior to completing two randomized 14-day cycles (4 social, 3 intolerant of anchor, and 3 intolerant of tube). Six participants were assessed for the primary outcome and showed no significant difference in weight loss between MM and ES (p = 0.082). For the secondary outcome of within-group weight loss, average weight loss from baseline was significant for MM but not for ES: -2.40 kg (95% CI: -3.78, -1.02; p = 0.008) vs. -0.64 kg (95% CI: -2.01, 0.74; p = 0.27). A total of 23 2-week cycles were completed (12 paired, 2 unpaired, and 9 additional), with no significant adverse events for 334 days of tube use.
CONCLUSIONS


Repeated bolus nutrient administration via enteral feeding tube is associated with weight loss in adults with obesity and type 2 diabetes, with no significant difference seen between MM and ES feeds. The prototype device was safe, but requires development for further investigation into the effect of bolus jejunal feeding on weight and to improve acceptability.",2020,Six participants were assessed for the primary outcome and showed no significant difference in weight loss between MM and ES (p = 0.082).,"['adults with obesity and type 2 diabetes', 'ambulatory adults with obesity and type 2 diabetes', 'ambulatory adults with type 2 diabetes and obesity', '16 participants']","['bolus enteral tube feeding', 'bolus enteral feeding with mixed meal (MM) and electrolyte solution (ES']","['body weight', 'weight loss', 'weight loss, average weight loss', 'weight change']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0041281', 'cui_str': 'Tube feeding of patient'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C3541941', 'cui_str': 'Electrolyte solutions'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]",6.0,0.0865442,Six participants were assessed for the primary outcome and showed no significant difference in weight loss between MM and ES (p = 0.082).,"[{'ForeName': 'E O', 'Initials': 'EO', 'LastName': 'Beale', 'Affiliation': 'Division of Endocrinology and Diabetes, Keck School of Medicine, University of Southern California, Los Angeles, 90033, CA, USA. beale@usc.edu.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Lee', 'Affiliation': 'Division of Endocrinology and Diabetes, Keck School of Medicine, University of Southern California, Los Angeles, 90033, CA, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Division of Endocrinology and Diabetes, Keck School of Medicine, University of Southern California, Los Angeles, 90033, CA, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'Division of Endocrinology and Diabetes, Keck School of Medicine, University of Southern California, Los Angeles, 90033, CA, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Soffer', 'Affiliation': 'Division of Gastroenterology, Keck School of Medicine, University of Southern California, Los Angeles, 90033, CA, USA.'}, {'ForeName': 'P F', 'Initials': 'PF', 'LastName': 'Crookes', 'Affiliation': 'Division of Foregut Surgery, Keck School of Medicine, University of Southern California, Los Angeles, 90033, CA, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Eagilen', 'Affiliation': 'Edward R. Roybal Comprehensive Health Center Dental Clinic, East Los Angeles, 90022, CA, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Edward R. Roybal Comprehensive Health Center Dental Clinic, East Los Angeles, 90022, CA, USA.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Mack', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, 90033, CA, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tong', 'Affiliation': 'Herman Ostrow School of Dentistry University of Southern California, Los Angeles, 90033, CA, USA.'}]",Nutrition & diabetes,['10.1038/s41387-020-0125-6']
2957,32555211,The effects of environmental enrichment on skin barrier recovery in humans: a randomised trial.,"This study investigated whether environmental enrichment (EE) could reduce stress and improve wound healing in humans. 120 participants underwent a standardised tape-stripping procedure and were then randomised to interact for 30 minutes with one of three EE interventions (comfort blankets as tactile enrichment, music as auditory enrichment or a Paro robot as multi-sensory enrichment) or to a control group. Skin barrier recovery (SBR) was measured using transepidermal water loss at baseline, after tape-stripping and after the intervention. Psychological variables, cortisol and alpha-amylase were measured at the three time-points. SBR did not significantly differ between the EE conditions and the control condition. The music condition had higher stimulation levels than the control condition, and the comfort condition had significantly lower relaxation levels than the control condition after the intervention. The EE interventions tested were not beneficial for wound healing compared to a control group. Limitations were that the sample were not stressed and an active control condition was used.",2020,SBR did not significantly differ between the EE conditions and the control condition.,"['120 participants underwent a', 'humans']","['environmental enrichment (EE', 'standardised tape-stripping procedure', 'environmental enrichment', 'EE interventions (comfort blankets as tactile enrichment, music as auditory enrichment or a Paro robot as multi-sensory enrichment) or to a control group']","['stimulation levels', 'SBR', 'skin barrier recovery', 'Skin barrier recovery (SBR', 'wound healing', 'relaxation levels', 'Psychological variables, cortisol and alpha-amylase']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0179330', 'cui_str': 'Blanket'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0002245', 'cui_str': 'alpha-Amylase'}]",120.0,0.0391175,SBR did not significantly differ between the EE conditions and the control condition.,"[{'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Law', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Jarrett', 'Affiliation': 'Department of Dermatology, Middlemore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Urs M', 'Initials': 'UM', 'LastName': 'Nater', 'Affiliation': 'Faculty of Psychology, University of Vienna, Vienna, 1010, Austria.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Skoluda', 'Affiliation': 'Faculty of Psychology, University of Vienna, Vienna, 1010, Austria.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Broadbent', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand. e.broadbent@auckland.ac.nz.'}]",Scientific reports,['10.1038/s41598-020-66687-2']
2958,32555927,Short-term efficacy and safety of levosimendan in patients with chronic systolic heart failure.,"The objective was to investigate and evaluate the short-term efficacy and safety of levosimendan in patients with chronic systolic heart failure. Forty-nine patients with chronic systolic heart failure during acute decompensation were randomly divided into a levosimendan group (26 cases) and a control group (23 cases). The control group received only routine treatment, while the levosimendan group received a levosimendan bolus with a load of 12 µg/kg, in addition to the same routine treatment as the control group. After 48 hours of treatment, N-terminal pro B-type natriuretic peptide (NT-proBNP) levels in the levosimendan group were significantly lower than those in the control group. In addition, the left ventricular ejection fraction (LVEF) and New York Heart Association (NYHA) cardiac function scores of the levosimendan group were significantly higher and more improved than those of the control group seven days after treatment, but there was no significant difference in the left ventricular end-diastolic diameter between the two groups. Furthermore, 48 hours after treatment, there were no significant differences in potassium, haemoglobin, haematocrit and creatinine levels between the levosimendan and control groups. During the whole hospitalisation, there was one case of sudden death in the control group and one case of palpitations in the levosimendan group, and no hypotension or severe hypokalaemia occurred in either group. Levosimendan significantly improved NT-proBNP and LVEF in patients with chronic systolic heart failure, and improved NYHA cardiac function classification without significant cardiovascular events. Levosimendan is therefore effective and safe in the short-term treatment of chronic systolic heart failure.",2020,"During the whole hospitalisation, there was one case of sudden death in the control group and one case of palpitations in the levosimendan group, and no hypotension or severe hypokalaemia occurred in either group.","['Forty-nine patients with chronic systolic heart failure during acute decompensation', 'patients with chronic systolic heart failure']","['Levosimendan', 'levosimendan', 'levosimendan bolus']","['sudden death', 'hypotension or severe hypokalaemia', 'left ventricular ejection fraction (LVEF) and New York Heart Association (NYHA) cardiac function scores', 'potassium, haemoglobin, haematocrit and creatinine levels', 'NT-proBNP and LVEF', 'left ventricular end-diastolic diameter']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1135194', 'cui_str': 'Chronic systolic heart failure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0231187', 'cui_str': 'Decompensation'}]","[{'cui': 'C0246904', 'cui_str': 'Levosimendan'}]","[{'cui': 'C0011071', 'cui_str': 'Sudden death'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0201975', 'cui_str': 'Creatinine measurement'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}]",49.0,0.0197414,"During the whole hospitalisation, there was one case of sudden death in the control group and one case of palpitations in the levosimendan group, and no hypotension or severe hypokalaemia occurred in either group.","[{'ForeName': 'Xiao-Ran', 'Initials': 'XR', 'LastName': 'Cui', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Xiao-Hong', 'Initials': 'XH', 'LastName': 'Yang', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Rui-Bin', 'Initials': 'RB', 'LastName': 'Li', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Jia', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Bai', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Ji-Dong', 'Initials': 'JD', 'LastName': 'Zhang', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China. Email: zhangjidong78@163.com.'}]",Cardiovascular journal of Africa,['10.5830/CVJA-2020-008']
2959,32555938,Comparative clinical evaluation of breast augmentation using silicone foam coated implants and textured implants.,"PURPOSE


To evaluate whether silicone foam implants have a different evolution pattern compared to conventional texture implants.
METHODS


Fifty-eight female patients underwent surgery. They were divided into two groups (silicone foam - Lifesil® - and microtexturized silicone - Lifesil®). The evolution was analyzed in postoperative consultations, with physical examination, photographic documentation and filling in a satisfaction questionnaire, in the postoperative period of one month, four months, one year and then annually, up to a maximum of 3 years of follow-up.
RESULTS


There were no statistically significant differences in presence of rippling, stretch marks, breast ptosis, capsular contracture and quality of scars. There was a higher rate of patients who were very satisfied with the outcome 360 days after surgery in the group receiving silicone foam implants (p = 0.036).
CONCLUSION


In short time, silicone foam envelope implants proved to be as reliable as textured silicone envelope implants, making them an option for augmentation mammoplasty.",2020,"There were no statistically significant differences in presence of rippling, stretch marks, breast ptosis, capsular contracture and quality of scars.",['Fifty-eight female patients underwent surgery'],"['silicone foam coated implants and textured implants', 'silicone foam - Lifesil® - and microtexturized silicone - Lifesil®', 'silicone foam implants']","['presence of rippling, stretch marks, breast ptosis, capsular contracture and quality of scars', 'postoperative consultations, with physical examination, photographic documentation and filling in a satisfaction questionnaire']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0152459', 'cui_str': 'Linear atrophy'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0005745', 'cui_str': 'Ptosis of eyelid'}, {'cui': 'C0205151', 'cui_str': 'Capsular'}, {'cui': 'C0009917', 'cui_str': 'Contracture'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",58.0,0.0308352,"There were no statistically significant differences in presence of rippling, stretch marks, breast ptosis, capsular contracture and quality of scars.","[{'ForeName': 'Ivana Leme de', 'Initials': 'IL', 'LastName': 'Calaes', 'Affiliation': 'Fellow PhD degree, Postgraduate Program in Surgical Sciences, Faculty of Medical Sciences, Universidade Estadual de Campinas (UNICAMP), Brazil. Scientific, intellectual, conception and design of the study; acquisition, analysis and interpretation of data; technical procedures; statistics analysis; manuscript preparation and writing; final approval.'}, {'ForeName': 'Marcos Matias', 'Initials': 'MM', 'LastName': 'Motta', 'Affiliation': 'Assistant Professor, Division of Plastic Surgery, UNICAMP, Campinas-SP, Brazil. Scientific and intellectual content of the study, technical procedures.'}, {'ForeName': 'Rafael de Campos', 'Initials': 'RC', 'LastName': 'Basso', 'Affiliation': 'Assistant Professor, Division of Plastic Surgery, UNICAMP, Campinas-SP, Brazil. Scientific and intellectual content of the study, statistics analysis.'}, {'ForeName': 'Davi Reis', 'Initials': 'DR', 'LastName': 'Calderoni', 'Affiliation': 'PhD, Division of Plastic Surgery, UNICAMP, Campinas-SP, Brazil. Scientific, intellectual, conception and design of the study; technical procedures; manuscript preparation.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Kharmandayan', 'Affiliation': 'Full Professor and Chairman, Division of Plastic Surgery, UNICAMP, Campinas-SP, Brazil. Scientific, intellectual, conception and design of the study; analysis and interpretation of data; technical procedures; manuscript preparation; critical revision; final approval.'}]",Acta cirurgica brasileira,['10.1590/s0102-865020200040000007']
2960,32555939,"Randomized, double-blind, placebo-controlled study of the analgesic effect of intraoperative esmolol for laparoscopic gastroplasty.","PURPOSE


To evaluate the analgesic effect of esmolol in patients submitted to laparoscopic gastroplasty.
METHODS


Forty patients aged between 18 and 50 years with American Society of Anesthesiologists (ASA) physical status scores of II and III who underwent gastric bypass were allocated to two groups. Group 1 patients received a 0.5-mg/kg bolus of esmolol in 30 mL of saline before induction of anesthesia, followed by an infusion at 15 µg/kg/min until the end of surgery. Group 2 patients received 30 mL of saline as a bolus and then an infusion of saline. Anesthesia included fentanyl (3 µg/kg), propofol (2-4 mg/kg), rocuronium (0.6 mg/kg), and 2% sevoflurane, with remifentanil if necessary. The following parameters were evaluated: pain intensity over 24h, remifentanil consumption, the first analgesic request, morphine consumption, and side effects.
RESULTS


Pain intensity was lower in the esmolol group except at T0 (after extubation) and 12h postoperatively. Remifentanil supplementation, recovery time, and postoperative morphine supplementation were lower in the esmolol group. No differences in the time to the first analgesic request or side effects were found between the groups.
CONCLUSION


Intraoperative esmolol promotes reductions in pain intensity and the need for analgesic supplementation without adverse effects, thus representing an effective drug for multimodal analgesia in gastroplasty.",2020,"RESULTS


Pain intensity was lower in the esmolol group except at T0 (after extubation) and 12h postoperatively.","['Forty patients aged between 18 and 50 years with American Society of Anesthesiologists (ASA) physical status scores of II and III who underwent gastric bypass', 'patients submitted to laparoscopic gastroplasty', 'laparoscopic gastroplasty']","['rocuronium', 'sevoflurane, with remifentanil', 'Remifentanil', 'Intraoperative esmolol', 'intraoperative esmolol', 'esmolol', '30 mL of saline', 'propofol', 'placebo']","['pain intensity', 'analgesic effect', 'Pain intensity', 'time to the first analgesic request or side effects', 'recovery time, and postoperative morphine supplementation', 'pain intensity over 24h, remifentanil consumption, the first analgesic request, morphine consumption, and side effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0017193', 'cui_str': 'Gastroplasty'}]","[{'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0116569', 'cui_str': 'esmolol'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",40.0,0.357074,"RESULTS


Pain intensity was lower in the esmolol group except at T0 (after extubation) and 12h postoperatively.","[{'ForeName': 'Vinicius Barros Duarte de', 'Initials': 'VBD', 'LastName': 'Morais', 'Affiliation': 'MD, Pain Sector, Department of Surgery, Universidade Federal de São Paulo (UNIFESP), Brazil, Design of the study, acquisition of data, final approval.'}, {'ForeName': 'Rioko Kimiko', 'Initials': 'RK', 'LastName': 'Sakata', 'Affiliation': 'PhD, Pain Sector, Department of Surgery, UNIFESP, Sao Paulo-SP, Brazil, Design of the study, manuscript writing, critical revision, final approval.'}, {'ForeName': 'Ana Paula Santana', 'Initials': 'APS', 'LastName': 'Huang', 'Affiliation': 'Master, Pain Sector, Department of Surgery, UNIFESP, Sao Paulo-SP, Brazil. Acquisition of data, final approval.'}, {'ForeName': 'Leonardo Henrique da Cunha', 'Initials': 'LHDC', 'LastName': 'Ferraro', 'Affiliation': 'PhD, Pain Sector, Department of Surgery, UNIFESP, Sao Paulo-SP, Brazil. Manuscript writing, final approval.'}]",Acta cirurgica brasileira,['10.1590/s0102-865020200040000008']
2961,32555986,Autonomic function may not modulate irisin release in healthy adults: findings from a randomized cross-over study.,"OBJECTIVE


Autonomic nervous system, especially the sympathetic nervous system, may stimulate the expression of peroxisome proliferator-activated receptor γ coactivator-1α, which regulates irisin. This study aimed to explore whether there was any association between autonomic function as assessed by heart rate related indices and irisin release following acute exercise.
SUBJECTS AND METHODS


Seventeen healthy adults were asked to perform an incremental exhaustive cycling as well as an incremental exhaustive running separately on different days. Heart rate was monitored, and blood samples were collected before, immediately, 10-, and 60-minutes post-exercise. Serum irisin was measured using ELISA kit.
RESULTS


Markers for autonomic function, such as heart rate at rest, peak, or recovery, heart rate reserve, heart rate recovery, and chronotropic index, were comparable between cycling and running (all P > 0.10). Irisin was increased immediately following both exercise. No significant association was observed between heart rate at rest, peak, or recovery and irisin level at the corresponding time-point, as well as between heart rate reserve, heart rate recovery, or chronotropic index and exercise induced irisin release, with or without controlling for age, body mass index, and glucose (all P > 0.10).
CONCLUSIONS


Autonomic function might not be associated with irisin release in healthy adults. Arch Endocrinol Metab. 2020;64(3):201-4.",2020,"No significant association was observed between heart rate at rest, peak, or recovery and irisin level at the corresponding time-point, as well as between heart rate reserve, heart rate recovery, or chronotropic index and exercise induced irisin release, with or without controlling for age, body mass index, and glucose (all P > 0.10).
","['Seventeen healthy adults', 'healthy adults']",[],"['heart rate at rest, peak, or recovery, heart rate reserve, heart rate recovery, and chronotropic index', 'heart rate reserve, heart rate recovery, or chronotropic index and exercise induced irisin release, with or without controlling for age, body mass index, and glucose', 'heart rate at rest, peak, or recovery and irisin level', 'Heart rate', 'Irisin', 'Serum irisin']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]",[],"[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",17.0,0.0253477,"No significant association was observed between heart rate at rest, peak, or recovery and irisin level at the corresponding time-point, as well as between heart rate reserve, heart rate recovery, or chronotropic index and exercise induced irisin release, with or without controlling for age, body mass index, and glucose (all P > 0.10).
","[{'ForeName': 'Shanhu', 'Initials': 'S', 'LastName': 'Qiu', 'Affiliation': ""Department of Endocrinology,Shenzhen People's Hospital; The Second Clinical Medical College of Jinan University; The First Affiliated Hospital of Southern University of Science and Technology, Shenzhen, China.""}, {'ForeName': 'Edit', 'Initials': 'E', 'LastName': 'Bosnyák', 'Affiliation': 'Division of Sports and Rehabilitation Medicine, Ulm University Medical Center, Ulm, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Zügel', 'Affiliation': 'Division of Sports and Rehabilitation Medicine, Ulm University Medical Center, Ulm, Germany.'}, {'ForeName': 'Jürgen Michael', 'Initials': 'JM', 'LastName': 'Steinacker', 'Affiliation': 'Division of Sports and Rehabilitation Medicine, Ulm University Medical Center, Ulm, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Schumann', 'Affiliation': 'Division of Sports and Rehabilitation Medicine, Ulm University Medical Center, Ulm, Germany.'}]",Archives of endocrinology and metabolism,['10.20945/2359-3997000000243']
2962,32555990,Intrathyroid injection of dexamethasone inhibits Th2 cells in Graves' disease.,"OBJECTIVE


Intrathyroid injection of dexamethasone (IID) was used for decrease the relapse rate of hyperthyroidism in the treatment of Graves' disease (GD), but the mechanism is still unclear. We aimed to explore the effect of IID on T help (Th)1/Th2 cells and their chemokine in patients with GD.
SUBJECTS AND METHODS


A total of 42 patients with GD who were euthyroidism by methimazole were randomly divided into IID group (n = 20) and control group (n = 22). Thyroid function and associated antibody, Th1/Th2 cells proportion, serum CXCL10 and CCL2 levels, and CXCR3/CCR2 mRNA expression in peripheral blood mononuclear cells before and after 3-month IID treatment were tested by chemiluminescence assay, Flow cytometry, ELISA, and real-time PCR, respectively. Thyroid follicular cells were stimulated by IFN-γ and TNF-α and treated with dexamethasone in vitro. CXCL10 and CCL2 levels in supernatant were determined.
RESULTS


After 3-month therapy, the proportion of Th2 cells and serum CCL2 levels, as well as TPOAb, TRAb levels and thyroid volume decreased in IID group (p < 0.05). However, the proportion of Th1 and CXCL10 levels had no change in IID group and control (p > 0.05). The CXCR3/CCR2 ratio had no change in both groups (p > 0.05).
CONCLUSION


IID therapy could inhibit peripheral Th2 cells via decreasing CCL2 level in peripheral blood, and this result partly explain the effects of IID therapy on prevention of relapse of GD. Arch Endocrinol Metab. 2020;64(3):243-50.",2020,"Thyroid follicular cells were stimulated by IFN-γ and TNF-α and treated with dexamethasone in vitro. CXCL10 and CCL2 levels in supernatant were determined.
","['patients with GD', '42 patients with GD who were euthyroidism by methimazole', ""Graves' disease"", ""Graves' disease (GD""]","['dexamethasone', 'dexamethasone (IID']","['proportion of Th2 cells and serum CCL2 levels', 'CXCR3/CCR2 ratio', 'Thyroid follicular cells', 'TPOAb, TRAb levels and thyroid volume', 'Thyroid function and associated antibody, Th1/Th2 cells proportion, serum CXCL10 and CCL2 levels, and CXCR3/CCR2 mRNA expression in peripheral blood mononuclear cells', 'proportion of Th1 and CXCL10 levels', 'relapse rate of hyperthyroidism']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0025644', 'cui_str': 'Methimazole'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0242633', 'cui_str': 'T helper subset 2 cell'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1449159', 'cui_str': 'CCL2 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1181052', 'cui_str': 'Thyrocytes'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C1308752', 'cui_str': 'CXCL10 protein, human'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0020550', 'cui_str': 'Hyperthyroidism'}]",42.0,0.0193606,"Thyroid follicular cells were stimulated by IFN-γ and TNF-α and treated with dexamethasone in vitro. CXCL10 and CCL2 levels in supernatant were determined.
","[{'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'He', 'Affiliation': 'Department of Endocrinology, Wuxi Hospital of Traditional Chinese Medicine, Wuxi Hospital Affiliated to Nanjing University of Chinese Medicine, Wuxi, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Jiang', 'Affiliation': 'Department of Thyroid and Breast Surgery, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Bing-Li', 'Initials': 'BL', 'LastName': 'Liu', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiao-Mei', 'Initials': 'XM', 'LastName': 'Liu', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiao-Ming', 'Initials': 'XM', 'LastName': 'Mao', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}]",Archives of endocrinology and metabolism,['10.20945/2359-3997000000244']
2963,32556001,The contribution of mindfulness to outpatient substance use disorder treatment in Brazil: a preliminary study.,"OBJECTIVE


To explore the contribution of a mindfulness-based intervention as an adjuvant to outpatient substance use disorder treatment. Outcomes included substance use behavior, depression and anxiety symptoms, and anger expression.
METHODS


This preliminary study for a pragmatic randomized controlled trial with stratified random allocation included three months of follow-up. In two outpatient clinics linked to public universities, a mindfulness-based intervention plus treatment as usual (experimental group n=22) was compared to treatment as usual (control group n=20). The study included data from self-report measurements and the patients' records, which were evaluated according to intention-to-treat analysis through generalized estimating equations and generalized method of moments estimation.
RESULTS


The experimental group had lower symptoms of depression (b=-6.82; 95%CI -12.45 to -1.18) and anxiety (b=-0.25; 95%CI -0.42 to -0.09), and anger expression (b=-9.76; 95%CI -18.98 to -0.54) three months after the intervention. We detected no effect on substance use behavior.
CONCLUSION


The mindfulness-based intervention yielded promising results as an adjuvant to outpatient substance use disorder treatment, since it reduced levels of highly prevalent symptoms in this population. However, further studies with longer follow-up periods and larger samples are required.",2020,"The experimental group had lower symptoms of depression (b=-6.82; 95%CI -12.45 to -1.18) and anxiety (b=-0.25; 95%CI -0.42 to -0.09), and anger expression (b=-9.76; 95%CI -18.98 to -0.54) three months after the intervention.",['Brazil'],['mindfulness-based intervention'],"['anger expression', 'substance use behavior, depression and anxiety symptoms, and anger expression', 'lower symptoms of depression', 'anxiety']","[{'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0930051,"The experimental group had lower symptoms of depression (b=-6.82; 95%CI -12.45 to -1.18) and anxiety (b=-0.25; 95%CI -0.42 to -0.09), and anger expression (b=-9.76; 95%CI -18.98 to -0.54) three months after the intervention.","[{'ForeName': 'Mayra P', 'Initials': 'MP', 'LastName': 'Machado', 'Affiliation': 'Departamento de Psicobiologia, Universidade Federal de São Paulo (UNIFESP), São Paulo, SP, Brazil.'}, {'ForeName': 'Thiago M', 'Initials': 'TM', 'LastName': 'Fidalgo', 'Affiliation': 'Departamento de Psiquiatria, UNIFESP, São Paulo, SP, Brazil.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Brasiliano', 'Affiliation': 'Programa da Mulher Dependente Química (PROMUD), Departamento e Instituto de Psiquiatria (IPq), Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo (USP), São Paulo, SP, Brazil.'}, {'ForeName': 'Patrícia B', 'Initials': 'PB', 'LastName': 'Hochgraf', 'Affiliation': 'Programa da Mulher Dependente Química (PROMUD), Departamento e Instituto de Psiquiatria (IPq), Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo (USP), São Paulo, SP, Brazil.'}, {'ForeName': 'Ana R', 'Initials': 'AR', 'LastName': 'Noto', 'Affiliation': 'Departamento de Psicobiologia, Universidade Federal de São Paulo (UNIFESP), São Paulo, SP, Brazil.'}]","Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999)",['10.1590/1516-4446-2019-0725']
2964,32555996,Metformin for prevention of cesarean delivery and large-for-gestational-age newborns in non-diabetic obese pregnant women: a randomized clinical trial.,"OBJECTIVE


To evaluate the use of metformin for preventing cesarean deliveries and large-for-gestational-age (LGA) newborn (NB) outcomes in non-diabetic obese pregnant women.
SUBJECTS AND METHODS


This is a randomized clinical trial with obese pregnant women, divided into 2 groups: metformin group and control group, with followed-up prenatal routine. The gestational age of participants was less than or equal to 20 weeks and were monitored throughout entire prenatal period. For outcomes of delivery and LGA newborns, absolute risk reduction (ARR) and the number needed to treat (NNT) were calculated with a 95% confidence interval (CI).
RESULTS


357 pregnant women were evaluated. From the metformin group (n = 171), 68 (39.8%) subjects underwent cesarean delivery, and 117 (62.9%) subjects from the control group (n = 186) had intercurrence (p < 0.01). As for the mothers' general characteristics, there was significance for marital status (p < 0.01). Maternal-fetal results presented reduced preeclampsia (p < 0,01). Primary prophylactic results presented an ARR of 23.1 times (95% CI: 13.0-33.4) with NNT of 4 (95% CI: 3.0-7.7) and no significant values for LGA NB (p > 0.01). Secondary prophylactic outcomes presented decreased odds ratio for preeclampsia (OR = 0.17, 95% CI: 0.10-0.41).
CONCLUSION


The use of metformin reduced cesarean section rates, resulted in a small number of patients to be treated, but it did not reduce LGA NB. Administering a lower dosage of metformin from the early stages to the end of treatment may yield significant results with fewer side effects. Arch Endocrinol Metab. 2020;64(3):290-7.",2020,"Secondary prophylactic outcomes presented decreased odds ratio for preeclampsia (OR = 0.17, 95% CI: 0.10-0.41).
","['obese pregnant women', '357 pregnant women', 'non-diabetic obese pregnant women', 'cesarean delivery and large-for-gestational-age newborns in non-diabetic obese pregnant women']","['Metformin', 'metformin group and control group, with followed-up prenatal routine', 'metformin']","['odds ratio for preeclampsia', 'cesarean section rates', 'cesarean deliveries and large-for-gestational-age (LGA) newborn (NB) outcomes', 'absolute risk reduction (ARR) and the number needed to treat (NNT', 'preeclampsia']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C4304643', 'cui_str': 'Large for gestational age newborn'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C1848395', 'cui_str': 'Large for dates baby'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}]",357.0,0.0746908,"Secondary prophylactic outcomes presented decreased odds ratio for preeclampsia (OR = 0.17, 95% CI: 0.10-0.41).
","[{'ForeName': 'Iramar Baptistella do', 'Initials': 'IBD', 'LastName': 'Nascimento', 'Affiliation': 'Centro de Ciências da Saúde e do Esporte (Cefid), Universidade do Estado de Santa Catarina (Udesc), Florianópolis, SC, Brasil.'}, {'ForeName': 'Willian Barbosa', 'Initials': 'WB', 'LastName': 'Sales', 'Affiliation': 'Universidade da Região de Joinville (Univille), Joinville, SC, Brasil.'}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': 'Dienstmann', 'Affiliation': 'Universidade da Região de Joinville (Univille), Joinville, SC, Brasil.'}, {'ForeName': 'Matheus Leite Ramos de', 'Initials': 'MLR', 'LastName': 'Souza', 'Affiliation': 'Universidade da Região de Joinville (Univille), Joinville, SC, Brasil.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Fleig', 'Affiliation': 'Centro de Educação do Planalto Norte (Ceplan), Universidade do Estado de Santa Catarina (Udesc), Florianópolis, SC, Brasil.'}, {'ForeName': 'Jean Carl', 'Initials': 'JC', 'LastName': 'Silva', 'Affiliation': 'Maternidade Darcy Vargas; Universidade da Região de Joinville (Univille), Joinville, SC, Brasil.'}]",Archives of endocrinology and metabolism,['10.20945/2359-3997000000251']
2965,32556008,Dentinal Tubule Penetration of a Calcium Silicate-Based Root Canal Sealer Using a Specific Calcium Fluorophore.,"This study aimed to evaluate penetrability on dentinal tubule of a new bioceramic sealer through confocal laser scanning microscopy (CLSM). A specific fluorophore (Fluo-3) was mixed with the sealer. Forty distobuccal roots from maxillary molars were selected, and root canal preparation was carried out with Wave One Gold # 35.06 instruments. Roots were randomly assigned to 4 groups according to the filling procedures: Bioceramic/Lentulo (Sealer Plus BC); Bioceramic/EasyClean group, three activation of the sealer (3x20 s) with Easy Clean instrument; Bioceramic/Irrisonic: ultrasonic activation for 30 s; and AHplus/Lentulo: epoxy resin based sealer (AH Plus) was utilized with the same protocol as the BC/LE group. After 72 h, specimens were transversally sectioned at 2 and 7 mm from root apex and then analyzed through CLSM. Sealer penetration area on dentinal tubule was measured by Adobe Photoshop CC2018. Kruskal Wallis and Wilcoxon T tests were carried out. Penetrability results were similar for both sealers regardless of which technique was performed to activate them inside the root canal (p>0.05). It is reasonable to conclude that penetration of bioceramic and epoxy resin based sealers occurred unimpressively. The type of instrument used to activate bioceramic sealer did not affect penetrability. Fluo 3 should be recommended as the fluorophore to evaluate dentinal tubule penetration of bioceramic sealers.",2020,Penetrability results were similar for both sealers regardless of which technique was performed to activate them inside the root canal (p>0.05).,['Forty distobuccal roots from maxillary molars'],"['confocal laser scanning microscopy (CLSM', 'Calcium Silicate-Based Root Canal Sealer', 'filling procedures: Bioceramic/Lentulo (Sealer Plus BC); Bioceramic/EasyClean group, three activation of the sealer (3x20 s) with Easy Clean instrument; Bioceramic/Irrisonic: ultrasonic activation for 30 s; and AHplus/Lentulo: epoxy resin based sealer (AH']",['Sealer penetration area on dentinal tubule'],"[{'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0242841', 'cui_str': 'Confocal Laser Scanning Microscopy'}, {'cui': 'C0054483', 'cui_str': 'calcium silicate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0449942', 'cui_str': 'Sealer'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1676076', 'cui_str': 'Sealer Plus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0014631', 'cui_str': 'Epoxy resin'}]","[{'cui': 'C0449942', 'cui_str': 'Sealer'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0227017', 'cui_str': 'Dentinal tubules'}]",,0.0177996,Penetrability results were similar for both sealers regardless of which technique was performed to activate them inside the root canal (p>0.05).,"[{'ForeName': 'Viviane Siqueira', 'Initials': 'VS', 'LastName': 'Coronas', 'Affiliation': 'Conservative Dentistry Department, School of Dentistry, UFRGS - Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Natália', 'Initials': 'N', 'LastName': 'Villa', 'Affiliation': 'Conservative Dentistry Department, School of Dentistry, UFRGS - Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Angela Longo do', 'Initials': 'ALD', 'LastName': 'Nascimento', 'Affiliation': 'Conservative Dentistry Department, School of Dentistry, UFRGS - Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Pedro Henrique Marks', 'Initials': 'PHM', 'LastName': 'Duarte', 'Affiliation': 'Conservative Dentistry Department, School of Dentistry, UFRGS - Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Ricardo Abreu da', 'Initials': 'RAD', 'LastName': 'Rosa', 'Affiliation': 'Conservative Dentistry Department, School of Dentistry, UFRGS - Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Marcus Vinícius Reis', 'Initials': 'MVR', 'LastName': 'Só', 'Affiliation': 'Conservative Dentistry Department, School of Dentistry, UFRGS - Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}]",Brazilian dental journal,['10.1590/0103-6440202002829']
2966,30629123,Association Between Brain β-Amyloid and Frailty in Older Adults.,"BACKGROUND


We sought to determine whether cortical and regional β-amyloid (Aβ) were cross-sectionally and prospectively associated with change in frailty status in older adults.
METHODS


We used data from 269 community-dwelling participants from the Multidomain Alzheimer's Preventive Trial (MAPT) who were assessed for brain Aβ using positron-emission tomography scan. Regional and cortical-to-cerebellar standardized uptake value ratios were obtained. Frailty was assessed by a frailty index composed of 19 items not directly linked to cognition and Alzheimer's disease.
RESULTS


A significant and positive cross-sectional and prospective relationship was found for Aβ in the anterior putamen (cross-sectional: β = 0.11 [0.02-0.20], p = .02; prospective: β = 0.11 [0.03-0.19], p = .007), posterior putamen (cross-sectional: β = 0.12 [0.009-0.23], p = .03; prospective: β = 0.11 [0.02-0.21], p = .02), and precuneus regions (cross-sectional: β = 0.07 [0.01-0.12], p = .01; prospective: β = 0.07 [0.01-0.12], p = .01) with increasing frailty.
CONCLUSIONS


This study has found new information regarding cross-sectional and prospective positive associations between region-specific brain Aβ deposits and worsening frailty. The potential mechanisms involved require further investigation.",2019,"RESULTS


A significant and positive cross-sectional and prospective relationship was found for Aβ in the anterior putamen (cross-sectional: β = 0.11 [0.02-0.20], p = .02; prospective: β = 0.11 [0.03-0.19], p = .007), posterior putamen (cross-sectional: β = 0.12 [0.009-0.23], p = .03; prospective: β = 0.11 [0.02-0.21], p = .02), and precuneus regions (cross-sectional: β = 0.07 [0.01-0.12], p = .01; prospective: β = 0.07 [0.01-0.12], p = .01) with increasing frailty.
","[""269 community-dwelling participants from the Multidomain Alzheimer's Preventive Trial (MAPT) who were assessed for brain Aβ using positron-emission tomography scan"", 'Older Adults', 'older adults']",[],[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]",[],[],269.0,0.0368262,"RESULTS


A significant and positive cross-sectional and prospective relationship was found for Aβ in the anterior putamen (cross-sectional: β = 0.11 [0.02-0.20], p = .02; prospective: β = 0.11 [0.03-0.19], p = .007), posterior putamen (cross-sectional: β = 0.12 [0.009-0.23], p = .03; prospective: β = 0.11 [0.02-0.21], p = .02), and precuneus regions (cross-sectional: β = 0.07 [0.01-0.12], p = .01; prospective: β = 0.07 [0.01-0.12], p = .01) with increasing frailty.
","[{'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Maltais', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse, France.'}, {'ForeName': 'Philipe', 'Initials': 'P', 'LastName': 'De Souto Barreto', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse, France.'}, {'ForeName': 'Claudie', 'Initials': 'C', 'LastName': 'Hooper', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Payoux', 'Affiliation': 'ToNIC, Toulouse NeuroImaging Center, Université de Toulouse INSERM, UPS, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rolland', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vellas', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glz009']
2967,30256303,Harness Suspension Stress: Physiological and Safety Assessment.,": Hanging motionless in a full body harness may result in unwanted events, such as acute hypotension and syncope, which has been termed harness suspension stress (HSS). The etiology of HSS has not been explored, and it is unknown if the type of harness influences the HSS response.
OBJECTIVES


Evaluate hemodynamics, subjective discomfort, and biological markers of muscle damage during 30-minutes suspension; and evaluate differences between harness attachment (frontal or dorsal).
METHODS


Heart rate, blood pressure, biological markers of muscle damage, and subjective discomfort were measured.
RESULTS


Trial time was shorter in the dorsal versus frontal point of attachment. Hemodynamic shift resulted in the dorsal trial which indicated possible perfusion abnormalities.
CONCLUSIONS


Hemodynamic adjustments contributed to early termination observed in the dorsal trial. A frontal point of attachment may be more suitable for extended harness exposure.",2019,"RESULTS


Trial time was shorter in the dorsal versus frontal point of attachment.",[],[],"['harness attachment (frontal or dorsal', 'Heart rate, blood pressure, biological markers of muscle damage, and subjective discomfort']",[],[],"[{'cui': 'C3873748', 'cui_str': 'Harness'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",,0.0677511,"RESULTS


Trial time was shorter in the dorsal versus frontal point of attachment.","[{'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Beverly', 'Affiliation': 'Department of Health, Exercise, and Sports Sciences, University of New Mexico, Albuquerque (Dr Beverly, Dr Zuhl, Dr McCormick, Dr Mermier); Department of Emergency Medicine, University of New Mexico Health Science Center, Albuquerque (Dr White, Ms Beverly, Dr Williams); School of Fitness Education, Santa Fe Community College, Santa Fe (Dr Beam), New Mexico; and Department of Exercise Science and Sports Management, Kennesaw State University, Kennesaw, Georgia (Dr VanDusseldorp).'}, {'ForeName': 'Micah N', 'Initials': 'MN', 'LastName': 'Zuhl', 'Affiliation': ''}, {'ForeName': 'Jenna M B', 'Initials': 'JMB', 'LastName': 'White', 'Affiliation': ''}, {'ForeName': 'Erin R', 'Initials': 'ER', 'LastName': 'Beverly', 'Affiliation': ''}, {'ForeName': 'Trisha A', 'Initials': 'TA', 'LastName': 'VanDusseldorp', 'Affiliation': ''}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'McCormick', 'Affiliation': ''}, {'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Beam', 'Affiliation': ''}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Mermier', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000001459']
2968,30406847,Diagnostic efficacy of dual-focus endoscopy with narrow-band imaging using simplified dyad criteria for superficial esophageal squamous cell carcinoma.,"BACKGROUND


Our previous studies have shown the diagnostic utility of a newly developed dual-focus endoscope with narrow-band imaging (DF-NBI) and simplified dyad criteria for detection of superficial esophageal squamous cell carcinoma (SESCC). This clinical trial aimed to study the diagnostic efficacy of DF-NBI with dyad criteria for detecting SESCC compared to white light imaging (WLI).
METHODS


This was a single-arm prospective comparative trial. We enrolled 170 consecutive high-risk patients for esophageal squamous cell carcinoma. Patients were initially examined with WLI by one independent endoscopist and then the other performed DF-NBI blinded to the WLI diagnosis to avoid a carry-over effect. Lesions showing proliferation and/or various shapes of intrapapillary capillary loops (IPCL) under DF-NBI (i.e., dyad criteria) were endoscopically diagnosed as SESCC including high-grade intraepithelial neoplasia. The primary endpoint was sensitivity of WLI and DF-NBI for detecting SESCC. The secondary endpoints were the diagnostic performance (i.e., specificity and accuracy) and inter/intra-observer concordance of DF-NBI with dyad criteria.
RESULTS


A total 77 SESCCs were detected. The sensitivity of DF-NBI for SESCC was significantly higher than that of WLI (91% vs. 51%, P < 0.001). The specificity and accuracy of WLI and DF-NBI using dyad criteria were 100% vs. 84%, and 86% vs. 86%, respectively. Various shapes and proliferation of IPCL showed the highest value in inter-observer and intra-observer agreements (κ = 0.77 and 0.82, respectively).
CONCLUSION


DF-NBI combined with dyad criteria may be a promising technique with a high sensitivity for diagnosis of SESCC and high inter/intra-observer agreement.",2019,"The specificity and accuracy of WLI and DF-NBI using dyad criteria were 100% vs. 84%, and 86% vs. 86%, respectively.","['170 consecutive high-risk patients for esophageal squamous cell carcinoma', 'superficial esophageal squamous cell carcinoma', 'superficial esophageal squamous cell carcinoma (SESCC']","['white light imaging (WLI', 'dual-focus endoscopy with narrow-band imaging using simplified dyad criteria']","['sensitivity of WLI and DF-NBI for detecting SESCC', 'diagnostic performance (i.e., specificity and accuracy) and inter/intra-observer concordance of DF-NBI with dyad criteria', 'specificity and accuracy of WLI and DF-NBI', 'sensitivity of DF-NBI for SESCC', 'Diagnostic efficacy']","[{'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}]","[{'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C3494253', 'cui_str': 'Narrowband Imaging'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0014243', 'cui_str': 'Endoscope'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3494253', 'cui_str': 'Narrowband Imaging'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",170.0,0.0465143,"The specificity and accuracy of WLI and DF-NBI using dyad criteria were 100% vs. 84%, and 86% vs. 86%, respectively.","[{'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Dobashi', 'Affiliation': 'Department of Endoscopy, The Jikei University School of Medicine, Tokyo, Japan. akira.dobashi1980@gmail.com.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Goda', 'Affiliation': 'Department of Endoscopy, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Furuhashi', 'Affiliation': 'Department of Endoscopy, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Matsui', 'Affiliation': 'Department of Endoscopy, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Hara', 'Affiliation': 'Department of Endoscopy, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Kamba', 'Affiliation': 'Department of Endoscopy, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Masakuni', 'Initials': 'M', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Endoscopy, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Sumiyama', 'Affiliation': 'Department of Endoscopy, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Hirooka', 'Affiliation': 'Department of Pathology, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shigeharu', 'Initials': 'S', 'LastName': 'Hamatani', 'Affiliation': 'Department of Pathology, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Rajan', 'Affiliation': 'Developmental Endoscopy Unit, Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Ikegami', 'Affiliation': 'Department of Pathology, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Tajiri', 'Affiliation': 'Department of Innovative Interventional Endoscopy Research, The Jikei University School of Medicine, Tokyo, Japan.'}]",Journal of gastroenterology,['10.1007/s00535-018-1527-2']
2969,32495411,Chronic antioxidant administration restores macrovascular function in patients with heart failure with reduced ejection fraction.,"NEW FINDINGS


What is the central question of this study? We aimed to examine oxidative stress, antioxidant capacity and macro- and microvascular function in response to 30 days of oral antioxidant administration in patients with heart failure with reduced ejection fraction. What is the main finding and its importance? We observed an approximately twofold improvement in macrovascular function, assessed via brachial artery flow-mediated dilatation, and a reduction in oxidative stress after antioxidant administration in patients with heart failure with reduced ejection fraction. The improvement in macrovascular function was reversed 1 week after treatment cessation. These findings have identified the potential of oral antioxidant administration to optimize macrovascular health in this patient group.
ABSTRACT


Heart failure with reduced ejection fraction (HFrEF) is characterized by macrovascular dysfunction and elevated oxidative stress that may be mitigated by antioxidant (AOx) administration. In this prospective study, we assessed flow-mediated dilatation (FMD) and reactive hyperaemia responses in 14 healthy, older control participants and 14 patients with HFrEF, followed by 30 days of oral AOx administration (1 g vitamin C, 600 I.U. vitamin E and 0.6 g α-lipoic acid) in the patient group. Blood biomarkers of oxidative stress (malondialdehyde) and AOx capacity (ferric reducing ability of plasma) were also assessed. Patients with HFrEF had a lower %FMD (2.63 ± 1.57%) than control participants (5.62 ± 2.60%), and AOx administration improved %FMD in patients with HFrEF (30 days, 4.90 ± 2.38%), effectively restoring macrovascular function to that of control participants. In a subset of patients, we observed a progressive improvement in %FMD across the treatment period (2.62 ± 1.62, 4.23 ± 2.69, 4.33 ± 2.24 and 4.97 ± 2.56% at days 0, 10, 20 and 30, respectively, n = 12) that was abolished 7 days after treatment cessation (2.99 ± 1.78%, n = 9). No difference in reactive hyperaemia was evident between groups or as a consequence of the AOx treatment. Ferric reducing ability of plasma levels increased (from 6.08 ± 2.80 to 6.70 ± 1.59 mm, day 0 versus 30) and malondialdehyde levels decreased (from 6.81 ± 2.80 to 6.22 ± 2.84 μm, day 0 versus 30) after treatment. These findings demonstrate the efficacy of chronic AOx administration in attenuating oxidative stress, improving AOx capacity and restoring macrovascular function in patients with HFrEF.",2020,Blood biomarkers of oxidative stress (malondialdehyde) and AOx capacity (ferric reducing ability of plasma) were also assessed.,"['14 healthy, older control participants and 14 patients with HFrEF, followed by 30\xa0days of oral AOx administration ', 'patients with HFrEF', 'patients with heart failure with reduced ejection fraction']","['vitamin\xa0E and 0.6\xa0g α-lipoic acid', 'oral antioxidant', 'Chronic antioxidant']","['Ferric reducing ability of plasma levels', 'Blood biomarkers of oxidative stress (malondialdehyde) and AOx capacity (ferric reducing ability of plasma', 'malondialdehyde levels', 'oxidative stress', 'FMD', 'reactive hyperaemia', 'AOx capacity and restoring macrovascular function', 'oxidative stress, antioxidant capacity and macro- and microvascular function', 'macrovascular function', 'macrovascular function, assessed via brachial artery flow-mediated dilatation', 'flow-mediated dilatation (FMD) and reactive hyperaemia responses']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C3848561', 'cui_str': 'ferric cation'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0442436', 'cui_str': 'Via brachial artery'}]",,0.083719,Blood biomarkers of oxidative stress (malondialdehyde) and AOx capacity (ferric reducing ability of plasma) were also assessed.,"[{'ForeName': 'Kanokwan', 'Initials': 'K', 'LastName': 'Bunsawat', 'Affiliation': 'Department of Internal Medicine, Division of Geriatrics, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Ratchford', 'Affiliation': 'Department of Internal Medicine, Division of Geriatrics, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Jeremy K', 'Initials': 'JK', 'LastName': 'Alpenglow', 'Affiliation': 'Department of Nutrition and Integrative Physiology, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Soung Hun', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Department of Nutrition and Integrative Physiology, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Jarrett', 'Affiliation': 'Department of Internal Medicine, Division of Geriatrics, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Stehlik', 'Affiliation': 'Department of Internal Medicine, Division of Cardiovascular Medicine, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Stavros G', 'Initials': 'SG', 'LastName': 'Drakos', 'Affiliation': 'Department of Internal Medicine, Division of Cardiovascular Medicine, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Russell S', 'Initials': 'RS', 'LastName': 'Richardson', 'Affiliation': 'Department of Internal Medicine, Division of Geriatrics, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'D Walter', 'Initials': 'DW', 'LastName': 'Wray', 'Affiliation': 'Department of Internal Medicine, Division of Geriatrics, University of Utah, Salt Lake City, UT, USA.'}]",Experimental physiology,['10.1113/EP088686']
2970,32559029,Regeneration of Secondary Dentin Using Recombinant Human Platelet-Derived Growth Factor and MTA for Pulp Capping: A Randomized Controlled Human Clinical Trial.,"This in vivo study assessed the effect of mineral trioxide aggregate (MTA) as a matrix carrier for recombinant human platelet-derived growth factor (rhPDGF) and enamel matrix protein (EMP) on pulp tissue healing following pulp capping. Eighteen intact human premolars scheduled for extraction were included. Coronal access and pulpotomy were performed, and each tooth was left exposed to the oral cavity for 1 hour before pulp capping was performed. Teeth were randomly assigned to one of the following pulp-capping groups (n = 6 each): Group 1 (MTA only); Group 2 (MTA+EMP); or Group 3 (MTA+rhPDGF). Coronal access cavities were then sealed. Immediate preoperative, postoperative, and 4-month follow-up radiographs were taken. At 4 months, the teeth were extracted atraumatically, and histomorphometric and micro-computed tomography (μCT) analyses were performed. Group 1 showed a thin, uneven, irregular dentin-like structure. Its average thickness was 0.3 ± 0.084 mm measured histologically and 0.29 ± 0.091 mm measured by μCT. Group 2 showed of a nonporous, even-thickness dentin-like structure with multiple root-canal obliterations. Highly dense, atubular dentin-like structures associated with presence of odontoblastic lacunae were seen. The structure's average thickness was 0.87 ± 0.09 mm (histologically) and 0.81 ± 0.17 mm (μCT). Group 3 showed a thick and complete 3D continuous seal of newly formed dentin-like structure covering the pulpal space. It resembled secondary dentin in form, porosity, and tubular structural organization, and its average thickness was 0.94 ± 0.02 mm (histologically) and 0.91 ± 0.09 mm (μCT). Groups 2 and 3 showed higher amounts of newly formed dentin-like structure, that was also thicker, than Group 1 ( P  < .05). No statistically significant differences in structure thickness were found between Groups 2 and 3. The nature of the structure can differ if rhPDGF or EMP is added to MTA for pulp-capping purposes. Combination of rhPDGF and MTA resulted in a newly formed structure resembling secondary dentin, whereas a combination of EMP and MTA produced a nonporous, highly dense dentinal-like structure associated with significant root-canal obliterations.",2020,"Groups 2 and 3 showed higher amounts of newly formed dentin-like structure, that was also thicker, than Group 1 ( P  < .05).",['Eighteen intact human premolars scheduled for extraction were included'],"['Recombinant Human Platelet-Derived Growth Factor and MTA', 'mineral trioxide aggregate (MTA', 'MTA+EMP); or Group 3 (MTA+rhPDGF', 'rhPDGF and MTA']","['structure thickness', 'odontoblastic lacunae', 'higher amounts of newly formed dentin-like structure']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0379135', 'cui_str': 'Becaplermin'}, {'cui': 'C0253527', 'cui_str': 'mineral trioxide aggregate'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C1299006', 'cui_str': 'Human platelet-derived growth factor'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}]",,0.0272097,"Groups 2 and 3 showed higher amounts of newly formed dentin-like structure, that was also thicker, than Group 1 ( P  < .05).","[{'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Al-Hezaimi', 'Affiliation': ''}, {'ForeName': 'Jafar', 'Initials': 'J', 'LastName': 'Naghshbandi', 'Affiliation': ''}, {'ForeName': 'Raed', 'Initials': 'R', 'LastName': 'Alhuzaimi', 'Affiliation': ''}, {'ForeName': 'Faisal', 'Initials': 'F', 'LastName': 'Alonizan', 'Affiliation': ''}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'AlQwizany', 'Affiliation': ''}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Rotstein', 'Affiliation': ''}]",The International journal of periodontics & restorative dentistry,['10.11607/prd.4766']
2971,32559039,"Ridge Augmentation Comparing a Cancellous Block Allograft to an Osteoinductive Demineralized Bone Matrix Allograft: A Randomized, Controlled, Blinded Clinical Trial.","Twenty-six patients with a horizontal ridge defect were entered into this 4-month randomized, controlled, blinded clinical trial to compare a cancellous block allograft to a demineralized bone matrix (DBM) allograft for ridge augmentation. Six patients were excluded from the study, leaving 20 for data interpretation. Both groups had a xenograft overlay and a collagen membrane. For the Block group there was a significant gain of 4.8 ± 1.9 mm ( P  = .00002; 95% confidence interval [CI]: 3.49 to 6.21), while the DBM group gained 4.6 ± 2.4 mm ( P  = .0002; 95% CI: 2.88 to 6.36). Vertical change was minimal for both groups ( P  > .05). The Block group had a mean of 40% vital bone while the DBM group had 35%.",2020,For the Block group there was a significant gain of 4.8 ± 1.9 mm ( P  = .00002,"['Six patients were excluded from the study, leaving 20 for data interpretation', 'Twenty-six patients with a horizontal ridge defect']","['cancellous block allograft to a demineralized bone matrix (DBM) allograft for ridge augmentation', 'Ridge Augmentation Comparing a Cancellous Block Allograft']","['mean of 40% vital bone', 'Vertical change']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0005962', 'cui_str': 'Bone matrix'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",6.0,0.213756,For the Block group there was a significant gain of 4.8 ± 1.9 mm ( P  = .00002,"[{'ForeName': 'Bobby Lee', 'Initials': 'BL', 'LastName': 'Cockerham', 'Affiliation': ''}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': ''}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Greenwell', 'Affiliation': ''}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Shumway', 'Affiliation': ''}, {'ForeName': 'Henry T', 'Initials': 'HT', 'LastName': 'Hsu', 'Affiliation': ''}]",The International journal of periodontics & restorative dentistry,['10.11607/prd.4324']
2972,32559052,Cementless Versus Cemented Tibial Fixation in Posterior Stabilized Total Knee Replacement: A Randomized Trial.,"BACKGROUND


Evidence supports the use of cementless tibial component fixation in total knee replacement but there is a paucity of literature on posterior stabilized designs. This randomized study of posterior stabilized total knee replacements compared cemented and cementless tibial fixation with regard to component migration, bone remodeling, and clinical outcomes.
METHODS


This prospective single-center, blinded, randomized clinical trial included 100 patients with a mean age of 68 years (range, 45 to 87 years). Operations were performed by either of 2 experienced arthroplasty surgeons using the Advanced Coated System (ACS) prosthesis (Implantcast). Patients were randomized to cemented or cementless tibial fixation; other variables were standardized. Radiostereometric analysis (RSA) and dual x-ray absorptiometry (DXA) were performed during the inpatient stay and at 3, 12, and 24 months to monitor tibial component migration and periprosthetic bone mineral density (BMD). Clinical scores including the Oxford Knee Score and Short Form-12 were assessed prior to surgery and during follow-up.
RESULTS


Late and continuing migration was found with cementless fixation. At 24 months, the mean subsidence was significantly greater for the cementless group (1.22 mm) compared with the cemented group (0.06 mm) (p < 0.01). The mean maximum total point motion at 24 months was 2.04 mm for the cementless group and 0.48 mm for the cemented group (p < 0.01). The cemented group had more BMD loss than the cementless group in the medial, lateral, and anterior periprosthetic regions. Two tibial components were revised in the cementless group, including 1 for loosening. Clinical scores improved equally in the 2 groups.
CONCLUSIONS


Late ongoing subsidence and high maximum total point motion in our patients who underwent cementless tibial fixation raise concerns about the fixation stability of ACS cementless posterior stabilized knee replacements. Cemented tibial components were stable. Thus, we advise caution regarding the use of cementless tibial components and recommend tibial fixation with cement for the ACS posterior stabilized total knee replacement.
LEVEL OF EVIDENCE


Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.",2020,"The cemented group had more BMD loss than the cementless group in the medial, lateral, and anterior periprosthetic regions.","['ACS cementless posterior stabilized knee replacements', 'Posterior Stabilized Total Knee Replacement', '100 patients with a mean age of 68 years (range, 45 to 87 years']","['cementless tibial fixation', 'cementless tibial component fixation', 'Cementless Versus Cemented Tibial Fixation', 'cemented or cementless tibial fixation', 'Advanced Coated System (ACS) prosthesis (Implantcast', 'posterior stabilized total knee replacements compared cemented and cementless tibial fixation']","['BMD loss', 'Clinical scores including the Oxford Knee Score and Short Form-12', 'mean subsidence', 'Radiostereometric analysis (RSA) and dual x-ray absorptiometry (DXA', 'mean maximum total point motion', 'Clinical scores', 'periprosthetic bone mineral density (BMD']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0449351', 'cui_str': 'Tibial component fixation'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3178874', 'cui_str': 'Roentgen Stereophotogrammetry'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026597', 'cui_str': 'Motion'}]",100.0,0.0541445,"The cemented group had more BMD loss than the cementless group in the medial, lateral, and anterior periprosthetic regions.","[{'ForeName': 'Nils Oscar', 'Initials': 'NO', 'LastName': 'Nivbrant', 'Affiliation': 'Department of Surgical and Perioperative Sciences, Orthopaedics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Riaz J K', 'Initials': 'RJK', 'LastName': 'Khan', 'Affiliation': 'The Joint Studio, Hollywood Medical Centre, Perth, Western Australia, Australia.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Fick', 'Affiliation': 'The Joint Studio, Hollywood Medical Centre, Perth, Western Australia, Australia.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Haebich', 'Affiliation': 'The Joint Studio, Hollywood Medical Centre, Perth, Western Australia, Australia.'}, {'ForeName': 'Ewan', 'Initials': 'E', 'LastName': 'Smith', 'Affiliation': 'The Joint Studio, Hollywood Medical Centre, Perth, Western Australia, Australia.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.01010']
2973,32559045,One-Year Outcomes of a Piscine Soft Tissue Alternative Used in Mucogingival Procedures: A Clinical Case Series.,"The free gingival graft (FGG) has been used predictably for gingival procedures aimed to increase the width of keratinized tissue (KT). Several soft tissue alternatives, such as xenografts and allografts, have been studied and proven to be successful with varying degrees. This pilot clinical case series evaluated the efficacy, safety, and initial clinical outcomes (measuring KT width) of a piscine xenograft material (Omega3 Wound, Kerecis) compared to the FGG (harvested from the patient palate) in correcting mucogingival deformities around teeth. A convenience sample of six subjects with unilateral or bilateral lack of KT were enrolled in the study. The primary objective of this pilot study was to determine the gain in width of KT. Secondary objectives included investigating the probing depth, recession depth, bleeding on probing, and inflammation score. There were three FGG sites and six xenograft sites. In bilateral-site treatments, FGG or piscine xenograft were randomly assigned. For unilateral sites, the piscine xenograft was used. Postoperatively, the patients returned for follow-up at 1, 2, 4, 12, 24, 48, and 52 weeks. All six subjects completed the 12-month study and reported uneventful healing. On average, the xenograft sites had a 3.25-mm gain in KT width, and the FGG had an average gain of 3.67 mm. This pilot clinical series showed the piscine xenograft to be safe and efficacious during healing and to increase the width of KT. Future studies may include a more robust study design with a greater number of subjects.",2020,The free gingival graft (FGG) has been used predictably for gingival procedures aimed to increase the width of keratinized tissue (KT).,['six subjects with unilateral or bilateral lack of KT were enrolled in the study'],['Piscine Soft Tissue Alternative Used in Mucogingival Procedures'],"['probing depth, recession depth, bleeding on probing, and inflammation score', 'uneventful healing', 'efficacy, safety, and initial clinical outcomes (measuring KT width) of a piscine xenograft material (Omega3 Wound, Kerecis', 'width of KT', 'gain in width of KT']","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0333047', 'cui_str': 'Recession'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0520484', 'cui_str': 'Xenogeneic transplantation'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0021501', 'cui_str': 'wounds'}]",6.0,0.032763,The free gingival graft (FGG) has been used predictably for gingival procedures aimed to increase the width of keratinized tissue (KT).,"[{'ForeName': 'Irina F', 'Initials': 'IF', 'LastName': 'Dragan', 'Affiliation': ''}, {'ForeName': 'A Alejandro', 'Initials': 'AA', 'LastName': 'Garcia H', 'Affiliation': ''}, {'ForeName': 'Raabia', 'Initials': 'R', 'LastName': 'Malik', 'Affiliation': ''}, {'ForeName': 'Nadeem Y', 'Initials': 'NY', 'LastName': 'Karimbux', 'Affiliation': ''}]",The International journal of periodontics & restorative dentistry,['10.11607/prd.4165']
2974,32559278,Diet Quality and Associations with Food Security among Women Eligible for Indiana Supplemental Nutrition Assistance Program-Education.,"BACKGROUND


The diet quality among adults receiving nutrition education lessons through Supplemental Nutrition Assistance Program-Education (SNAP-Ed) is currently unknown.
OBJECTIVES


The objectives of this study were to characterize the diet quality of Indiana SNAP-Ed-eligible women; estimate their mean usual intake of fruits, vegetables, dairy, and whole grains compared to Dietary Guidelines for Americans (DGA) recommendations; and determine if these dietary outcomes differed by food security status.
METHODS


SNAP-Ed paraprofessionals recruited participants from August 2015 to May 2016 for this secondary analysis of cross-sectional data collected as the baseline assessment for a randomized controlled trial. Participants were SNAP-Ed-eligible women aged ≥18 y interested in nutrition education lessons. Dietary outcomes were assessed by one or two 24-h dietary recalls. The Healthy Eating Index (HEI)-2010 was used to characterize diet quality. Mean usual intake of food groups was estimated using the National Cancer Institute Method. Food security status was classified using the US Household Food Security Survey Module. Data were analyzed in October 2019.
RESULTS


Mean ± SEM HEI-2010 total score was 42 ± 0.9 for the study sample. Mean ± SE usual intake of servings of fruits (0.61 ± 0.08 cups [144.32 ± 18.93 mL]), vegetables [1.4 ± 0.10 cups (331.2 ± 23.66 mL)], dairy [1.5 ± 0.11 cups (354.88 ± 26.02 mL)], and whole grains [0.48 ± 0.06 ounces (13.61 ± 1.70 g)] did not differ by food security subgroup. Mean HEI-2010 total score was significantly higher by 4.8 ± 2.0 points for the food-secure than for the food-insecure subgroup (P = 0.01). Mean HEI-2010 component scores were 1.1 ± 0.5 points higher for whole grain (P = 0.01) and 1.0 ± 0.5 points higher for dairy (P = 0.05) in the food-secure than in the food-insecure subgroup. The proportions of the study sample not meeting the DGA recommendations for food group intake were ≥85% for both food-secure and -insecure subgroups.
CONCLUSIONS


Indiana SNAP-Ed-eligible women reported poor diet quality, highlighting their need for nutrition interventions aiming to improve food security and diet as per DGA recommendations in low-income populations.",2020,Mean HEI-2010 total score was significantly higher by 4.8 ± 2.0 points for the food-secure than for the food-insecure subgroup (P = 0.01).,"['Women Eligible for Indiana Supplemental Nutrition Assistance Program-Education', 'Participants were SNAP-Ed-eligible women aged ≥18 y interested in nutrition education lessons', 'SNAP-Ed paraprofessionals recruited participants from August 2015 to May 2016 for this secondary analysis of cross-sectional data collected as the baseline assessment for a randomized controlled trial', 'Indiana SNAP-Ed-eligible women', 'adults receiving nutrition education lessons']",[],"['Mean HEI-2010 total score', 'Mean HEI-2010 component scores', 'Healthy Eating Index', 'Mean\xa0±\xa0SEM HEI-2010 total score', 'Mean\xa0±\xa0SE usual intake of servings of fruits']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021206', 'cui_str': 'Indiana'}, {'cui': 'C3494397', 'cui_str': 'SNAP Program'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}]",,0.0751539,Mean HEI-2010 total score was significantly higher by 4.8 ± 2.0 points for the food-secure than for the food-insecure subgroup (P = 0.01).,"[{'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Rivera', 'Affiliation': 'Department of Nutrition Science, Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Yumin', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Statistics, Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Statistics, Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Melissa K', 'Initials': 'MK', 'LastName': 'Maulding', 'Affiliation': 'Department of Nutrition and Dietetics, Eastern Illinois University, Charleston, IL, USA.'}, {'ForeName': 'Janet A', 'Initials': 'JA', 'LastName': 'Tooze', 'Affiliation': 'School of Medicine, Wake Forest University, Winston-Salem, NC, USA.'}, {'ForeName': 'Breanne N', 'Initials': 'BN', 'LastName': 'Wright', 'Affiliation': 'Department of Nutrition Science, Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Craig', 'Affiliation': 'Department of Statistics, Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Regan L', 'Initials': 'RL', 'LastName': 'Bailey', 'Affiliation': 'Department of Nutrition Science, Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Eicher-Miller', 'Affiliation': 'Department of Nutrition Science, Purdue University, West Lafayette, IN, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa171']
2975,32559335,Phase II Study of Low-Dose Afatinib Maintenance Treatment Among Patients with EGFR-Mutated Non-Small Cell Lung Cancer: North Japan Lung Cancer Study Group Trial 1601 (NJLCG1601).,"TRIAL INFORMATION


ClinicalTrials.gov Identifier: UMIN 000020688 [EMBED URL: https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000020688] Sponsor: North Japan Lung Cancer Study Group Principal Investigator: Atsushi Nakamura IRB Approved: Yes LESSONS LEARNED: Low-dose afatinib maintenance treatment among patients with EGFR-mutated NSCLC allowed for treatment continuation for longer with fewer treatment-related AEs without detracting from the therapeutic efficacy. This modified regimen represents a practical usage that balances effectiveness and safety.
BACKGROUND


Although afatinib is an effective therapy for patients with EGFR-mutated non-small cell lung cancer (NSCLC), drug-related adverse events (AEs) have often necessitated dose reductions. In a post hoc analysis of the LUX-Lung 3 and 6 trials, there was no difference in median progression-free survival (PFS) between patients who had the dose of afatinib reduced and those who did not. We thus evaluated the efficacy and tolerability of low-dose afatinib maintenance treatment among patients with NSCLC harboring EGFR mutations who had not been previously treated.
METHODS


Eligible patients received afatinib 40 mg orally once daily. When prescribed grade ≥ 2 AEs, rash of grade ≥ 3, or unacceptable toxicity occurred, the afatinib dose was reduced from 40 to 30 mg and if needed from 30 to 20 mg. The primary endpoint was the 1-year PFS rate. Secondary endpoints were PFS, overall response rate (ORR), and toxicity.
RESULTS


Among 30 patients, 93% had adenocarcinoma, 53% had exon 19 deletion, 37% had L858R, and 10% had minor mutations. The 1-year PFS rate was 50% (95% confidence interval [CI], 31.3-66.1) and the median PFS was 11.8 months (95% CI, 7.1-21.4). The incidence rate of grade ≥ 3 toxicities was 57%, including elevated aspartate aminotransferase/alanine aminotransferase level (13%), diarrhea (10%), and paronychia (10%).
CONCLUSION


Low-dose afatinib maintenance treatment reduced treatment-related AEs without detracting from the therapeutic efficacy.",2020,"The 1-year PFS rate was 50% (95% confidence interval [CI], 31.3-66.1) and the median PFS was 11.8 months (95% CI, 7.1-21.4).","['Eligible patients received', 'patients with EGFR-mutated non-small cell lung cancer (NSCLC', 'patients with EGFR-mutated NSCLC', 'Patients with EGFR-Mutated Non-Small Cell Lung Cancer', 'patients with NSCLC harboring EGFR mutations who had not been previously treated']","['afatinib 40 mg orally once daily', 'Low-Dose Afatinib Maintenance Treatment']","['diarrhea', 'incidence rate of grade ≥\u20093 toxicities', 'paronychia', '1-year PFS rate', 'PFS, overall response rate (ORR), and toxicity', 'elevated aspartate aminotransferase/alanine aminotransferase level', 'efficacy and tolerability', 'median progression-free survival (PFS', 'unacceptable toxicity', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C3652037', 'cui_str': 'Afatinib 40 MG [Gilotrif]'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C2987648', 'cui_str': 'Afatinib'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0030578', 'cui_str': 'Paronychia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.240061,"The 1-year PFS rate was 50% (95% confidence interval [CI], 31.3-66.1) and the median PFS was 11.8 months (95% CI, 7.1-21.4).","[{'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Department of Respiratory Medicine, Hirosaki University, Hirosaki, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Saito', 'Affiliation': 'Department of Respiratory Medicine, Tohoku University Hospital, Sendai, Japan.'}, {'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Suzuki', 'Affiliation': 'Department of Respiratory Medicine, Miyagi Cancer Center, Natori, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Harada', 'Affiliation': 'Department of Respiratory Medicine, JCHO Hokkaido Hospital, Sapporo, Japan.'}, {'ForeName': 'Sumito', 'Initials': 'S', 'LastName': 'Inoue', 'Affiliation': 'Department of Cardiology, Pulmonology, and Nephrology, Yamagata University Faculty of Medicine, Yamagata, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'First Department of Internal Medicine, Toyama University Hospital, Toyama, Japan.'}, {'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Nakagawa', 'Affiliation': 'Dapartment of Thoracic Surgery, Omagari Kosei Medical Center, Daisen, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Jingu', 'Affiliation': 'Department of Respiratory Medicine, Saka General, Shiogama, Japan.'}, {'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Sugawara', 'Affiliation': 'Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan.'}]",The oncologist,['10.1634/theoncologist.2020-0545']
2976,32559392,The Effect of Motivational Interviewing on Self-Efficacy and Continuation of Exclusive Breastfeeding Rates: A Quasi-Experimental Study.,"Background:  Self-efficacy is a decisive psychological and motivational factor in maintaining exclusive breastfeeding (EBF). The aim of this study was to explore the impact of motivational interviewing (MI) on EBF self-efficacy and EBF in primiparous women.  Materials and Methods:  This quasi-experimental study was conducted on 140 primiparous women admitted to a number of comprehensive health centers in Zahedan in 2019. The health centers were determined through multistage random sampling, and the subjects were selected from each center using convenience sampling. The selected women were equally divided into the intervention and control groups. The two groups took the pretest by filling out a demographic questionnaire and a breastfeeding self-efficacy questionnaire. The intervention group attended four 45- to 60-minute MI sessions on breastfeeding. The EBF continuation sheet and the breastfeeding self-efficacy questionnaire were filled out 6 months postpartum. Data were analyzed in SPSS 22 using paired  t -test, independent  t -test, chi-square test, and covariance analysis.  Results:  Based on the results, the mean and standard deviation of the number of EBF days were significantly higher in the intervention group (137.68 ± 65.50) compared with that of the control group (99.51 ± 80.62). In addition, the mean score of breastfeeding self-efficacy after MI was significantly different between the two groups ( p  = 0.0001).  Conclusion:  Because of the significantly positive impact of MI on enhancing EBF self-efficacy and continuation, it is recommended to integrate this counseling strategy into the care programs designed for women in pregnancy and even postpartum period.",2020,"In addition, the mean score of breastfeeding self-efficacy after MI was significantly different between the two groups ( p  = 0.0001).  ","['primiparous women', '140 primiparous women admitted to a number of comprehensive health centers in Zahedan in 2019']","['motivational interviewing (MI', 'Motivational Interviewing']","['Self-Efficacy and Continuation of Exclusive Breastfeeding Rates', 'breastfeeding self-efficacy questionnaire', 'EBF self-efficacy and EBF', 'mean score of breastfeeding self-efficacy after MI', 'EBF self-efficacy and continuation', 'mean and standard deviation of the number of EBF days']","[{'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0475309', 'cui_str': 'Health center'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",140.0,0.0167012,"In addition, the mean score of breastfeeding self-efficacy after MI was significantly different between the two groups ( p  = 0.0001).  ","[{'ForeName': 'Homeyra', 'Initials': 'H', 'LastName': 'Naroee', 'Affiliation': 'Department of Midwifery, Nursing and Midwifery School, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Marzihe', 'Initials': 'M', 'LastName': 'Rakhshkhorshid', 'Affiliation': 'Department of Midwifery, Nursing and Midwifery School, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Mansour', 'Initials': 'M', 'LastName': 'Shakiba', 'Affiliation': 'Department of Psychiatry, Medicine School, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Navidian', 'Affiliation': 'Department of Counseling, Pregnancy Health Research Center, Nursing and Midwifery School, Zahedan University of Medical Sciences, Zahedan, Iran.'}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2019.0252']
2977,32559403,A Primary Care Randomized Controlled Trial of Hall and Conventional Restorative Techniques.,"OBJECTIVES


To investigate treatment outcomes of different restorative techniques undertaken by dental therapists for primary molar carious lesions in a sample of children in New Zealand primary care.
METHODS


This was a randomized controlled trial with children aged 3 to 8 y in New Zealand's Whanganui region. Children meeting inclusion criteria were randomly allocated to treatment with either the Hall technique (HT), in which a stainless-steel crown (SSC) is placed without any carious tissue removal or tooth preparation, or a non-Hall conventional restorative approach (NHT), including tooth preparation with selective carious tissue removal; this included SSC, amalgam, composite, or glass ionomer cement (GIC) restorations. Restorative outcomes after 12 and 24 mo were categorized as success, minor failure, or major failure.
RESULTS


Of the 295 eligible children, 149 and 146 were allocated to the HT and NHT groups, respectively, with a total of 570 carious primary molars treated by 13 dental therapists. The participant follow-up rates at 12 and 24 mo were 95% and 91%. SSCs were the most commonly used restoration in the NHT group (60%), followed by GIC (28%). SSCs were the most successful restorations regardless of whether they were placed with the HT or NHT, with success rates of 89% and 92% at 12 mo and 85% and 86% at 24 mo. In the NHT group, the treatment material was a predictor of minor failure at 12 and 24 mo, with significantly more failures with GICs.
CONCLUSIONS


SSCs placed by dental therapists are a highly successful restoration for the primary dentition, regardless of whether they are placed with the HT or conventionally. The high failure rate of glass ionomer restorations means that they cannot be recommended for widespread use in New Zealand primary care (Australian New Zealand Clinical Trials Registry, ACTRN12614000844640).
KNOWLEDGE TRANSFER STATEMENT


The findings of this study can be used by policy makers and clinicians when deciding on which materials and which approach to use to maximize success and to minimize retreatment rates when providing restorative treatment for carious primary molars in children's primary oral health care. Results also suggest that undertaking research in the primary care setting may enhance translation of new knowledge and techniques into clinicians' hands.",2020,"SSCs were the most successful restorations regardless of whether they were placed with the HT or NHT, with success rates of 89% and 92% at 12 mo and 85% and 86% at 24 mo.","[""carious primary molars in children's primary oral health care"", 'Children meeting inclusion criteria', '295 eligible children, 149 and 146 were allocated to the HT and NHT groups, respectively, with a total of 570 carious primary molars treated by 13 dental therapists', 'primary molar carious lesions in a sample of children in New Zealand primary care', ""children aged 3 to 8 y in New Zealand's Whanganui region""]","['Hall and Conventional Restorative Techniques', 'stainless-steel crown (SSC) is placed without any carious tissue removal or tooth preparation, or a non-Hall conventional restorative approach (NHT), including tooth preparation with selective carious tissue removal; this included SSC, amalgam, composite, or glass ionomer cement (GIC) restorations', 'Hall technique (HT']","['success rates', 'Restorative outcomes', 'success, minor failure, or major failure']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0038126', 'cui_str': 'Stainless steel material'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0376508', 'cui_str': 'Tooth Preparation'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0440138', 'cui_str': 'Amalgam (silver) dental filling material'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0017597', 'cui_str': 'Glass-ionomer dental material'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",570.0,0.125032,"SSCs were the most successful restorations regardless of whether they were placed with the HT or NHT, with success rates of 89% and 92% at 12 mo and 85% and 86% at 24 mo.","[{'ForeName': 'D H', 'Initials': 'DH', 'LastName': 'Boyd', 'Affiliation': 'Department of Oral Sciences, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'W M', 'Initials': 'WM', 'LastName': 'Thomson', 'Affiliation': 'Department of Oral Sciences, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Leon de la Barra', 'Affiliation': 'Consulting biostatistician, Waitaki Community Gardens, Oamaru, New Zealand.'}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Fuge', 'Affiliation': 'Wellington Regional Dental Service, Hutt Valley District Health Board, Lower Hutt, New Zealand.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'van den Heever', 'Affiliation': 'The Dentists Taradale, Napier, New Zealand.'}, {'ForeName': 'B M', 'Initials': 'BM', 'LastName': 'Butler', 'Affiliation': 'Dental Department, MidCentral District Health Board, Palmerston North, New Zealand.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Leov', 'Affiliation': 'Waikato District Health Board, Hamilton, New Zealand.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Foster Page', 'Affiliation': 'Department of Oral Sciences, University of Otago, Dunedin, New Zealand.'}]",JDR clinical and translational research,['10.1177/2380084420933154']
2978,32559602,Efficacy and safety of vilaprisan in women with uterine fibroids: Data from the phase 2b randomized controlled trial ASTEROID 2.,"OBJECTIVE


To assess the efficacy of vilaprisan compared with placebo in the management of the symptoms of uterine fibroids (UF), with a secondary objective to provide a descriptive comparison with ulipristal acetate.
STUDY DESIGN


The randomized, parallel-group, double-blind, placebo- and active-controlled, multicenter ASTEROID 2 trial assessed the efficacy and safety of vilaprisan versus placebo and ulipristal acetate for two 12-week treatment periods in women with ≥1 UF experiencing heavy menstrual bleeding (HMB). The primary endpoint compared the efficacy of vilaprisan with placebo at 12 weeks, assessed as the absence of bleeding/spotting by bleeding diary. Secondary endpoints compared the efficacy of vilaprisan with ulipristal acetate. Results of the first 12-week treatment period are reported here.
RESULTS


Women (mean age 42.5 years) were enrolled from 1 June 2015. At baseline, mean menstrual blood loss per 28 days was 214.1 mL and the volume of the three largest UF was 106.2 mL. In total, 155 women completed the initial 12-week treatment period. Complete absence of bleeding/spotting until the end of the 12-week treatment period was achieved by 62.9 % of women receiving vilaprisan versus 0.0 % with placebo (p < .001); 55.4 % of women treated with ulipristal acetate reported absence of bleeding/spotting. The predefined HMB response (<80 mL and >50 % reduction from baseline during the last 28 days of treatment) was observed in 95.7 % of subjects treated with vilaprisan and 86.5 % of subjects treated with ulipristal acetate. Vilaprisan and ulipristal acetate treatment reduced the sum of the volume of the three largest UF by 29.9 % and 23.8 %, respectively, whereas an increase of 6.3 % was observed in the placebo group. No safety concerns, including multiple laboratory parameters, were identified.
CONCLUSION


Daily administration of vilaprisan 2 mg induced amenorrhea, controlled bleeding, decreased UF size, and was well tolerated in women with HMB associated with UF.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov number: NCT02465814 https://clinicaltrials.gov/ct2/show/NCT02465814.",2020,"Vilaprisan and ulipristal acetate treatment reduced the sum of the volume of the three largest UF by 29.9 % and 23.8 %, respectively, whereas an increase of 6.3 % was observed in the placebo group.","['women with ≥1 UF experiencing heavy menstrual bleeding (HMB', 'women with uterine fibroids', 'Women (mean age 42.5 years) were enrolled from 1 June 2015', '155 women completed the initial 12-week treatment period']","['Vilaprisan and ulipristal acetate', 'ulipristal acetate', 'vilaprisan versus placebo and ulipristal acetate', 'vilaprisan', 'placebo']","['mean menstrual blood loss', 'HMB response', 'Efficacy and safety', 'absence of bleeding/spotting by bleeding diary', 'Complete absence of bleeding/spotting', 'efficacy and safety', 'amenorrhea, controlled bleeding, decreased UF size', 'efficacy of vilaprisan', 'efficacy of vilaprisan with ulipristal acetate', 'absence of bleeding/spotting']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0025323', 'cui_str': 'Menorrhagia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4508937', 'cui_str': 'vilaprisan'}, {'cui': 'C2723461', 'cui_str': 'Ulipristal acetate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0694689', 'cui_str': 'Menstrual blood'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0002453', 'cui_str': 'Amenorrhea'}, {'cui': 'C0149533', 'cui_str': 'Control of hemorrhage'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C4508937', 'cui_str': 'vilaprisan'}, {'cui': 'C2723461', 'cui_str': 'Ulipristal acetate'}]",155.0,0.413833,"Vilaprisan and ulipristal acetate treatment reduced the sum of the volume of the three largest UF by 29.9 % and 23.8 %, respectively, whereas an increase of 6.3 % was observed in the placebo group.","[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Gemzell-Danielsson', 'Affiliation': ""Department of Women's and Children's Health, Division of Obstetrics and Gynecology, Karolinska Institutet, and Karolinska University Hospital, S-171 76, Stockholm, Sweden. Electronic address: Kristina.Gemzell@ki.se.""}, {'ForeName': 'Oskari', 'Initials': 'O', 'LastName': 'Heikinheimo', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, PO Box 140, 00029-HUS, Helsinki, Finland. Electronic address: oskari.heikinheimo@helsinki.fi.'}, {'ForeName': 'Janos', 'Initials': 'J', 'LastName': 'Zatik', 'Affiliation': 'Szent Anna Szuleszeti, Nogyogyaszati es Ultrahang Magan Rendelo, 48 Szent Anna utca, Debrecen, Hungary. Electronic address: jzatik@yahoo.com.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Poka', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Debrecen, Nagyerdei krt. 98, 4032, Debrecen, Hungary. Electronic address: pokar@med.unideb.hu.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Rechberger', 'Affiliation': 'II Department of Gynecology, Medical University of Lublin, Racławickie 1 Street, 20-059, Lublin, Poland. Electronic address: rechbergt@yahoo.com.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hudecek', 'Affiliation': 'Department of Obstetrics and Gynecology, Brno University Hospital and Masaryk University Medical School, Jihlavská 20, CZ - 625 00, Brno, Czech Republic. Electronic address: hudecek.robert@fnbrno.cz.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Petersdorf', 'Affiliation': 'Bayer AG, Müllerstraße 178, 13342, Berlin, Germany. Electronic address: Kathrin.petersdorf@bayer.com.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Ramirez', 'Affiliation': 'Syneos Health, Frankfurter StraBe 233 Triforum, Haus C1 Neu-Isenburg, 63263, Germany. Electronic address: francisco.ramirez1.ext@bayer.com.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Faustmann', 'Affiliation': 'Bayer AG, Müllerstraße 178, 13342, Berlin, Germany. Electronic address: thomas.faustmann@bayer.com.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Groettrup-Wolfers', 'Affiliation': 'Bayer AG, Müllerstraße 178, 13342, Berlin, Germany. Electronic address: Esther.groettrup-wolfers@bayer.com.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Seitz', 'Affiliation': 'Bayer AG, Müllerstraße 178, 13342, Berlin, Germany. Electronic address: Christian.seitz@bayer.com.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.05.043']
2979,32559644,Compensation of stochastic time-continuous perturbations during walking in healthy young adults: An analysis of the structure of gait variability.,"BACKGROUND


During everyday locomotion, we cope with various internal or external perturbations (e.g. uneven surface). Uncertainty exists on how unpredictable external perturbations increase noise within the motor system and if they are compensated by employing covariation of the limb joints or rather due to decreased sensitivity of an altered posture.
RESEARCH QUESTION


Do continuous stochastic perturbations affect the structure of gait variability in young and healthy adults?
METHODS


In a cross-over study, gait kinematics of 21 healthy young sports students were registered during treadmill walking with and without continuous stochastic perturbations. Using the TNC method, the following aspects were analyzed: (a) the sensitivity of body posture to perturbations ('tolerance') decreasing gait variability, (b) the unstructured motor 'noise' increasing gait variability and (c) the amount of 'covariation' of the limb joints.
RESULTS


Compared to normal walking, gait variability was significantly increased (p < .001) during walking with perturbations. The negative effect of noise was partly compensated by improved 'covariation' of leg joints (p < .001). The aspect 'tolerance' had a small effect on increasing gait variability during stance phase (p < .001) and decreasing gait variability during swing phase (p < .001).
SIGNIFICANCE


Increased motor noise due to external perturbations is partly compensated by improved covariation of the limb joints. However, the effect of an altered posture slightly affects gait variability. Further studies should focus on different populations (e.g. older participants) to see if they use the same mechanism (improved covariation) to compensate for stochastic perturbations.",2020,"The aspect 'tolerance' had a small effect on increasing gait variability during stance phase (p < .001) and decreasing gait variability during swing phase (p < .001).
","['young and healthy adults', '21 healthy young sports students', 'healthy young adults']",['treadmill walking with and without continuous stochastic perturbations'],"[""sensitivity of body posture to perturbations ('tolerance') decreasing gait variability, (b) the unstructured motor 'noise' increasing gait variability and (c) the amount of 'covariation' of the limb joints"", 'gait variability', 'normal walking, gait variability', ""covariation' of leg joints""]","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1262869', 'cui_str': 'Body position'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",21.0,0.0319459,"The aspect 'tolerance' had a small effect on increasing gait variability during stance phase (p < .001) and decreasing gait variability during swing phase (p < .001).
","[{'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Koch', 'Affiliation': 'Institute of Sports Science, Friedrich Schiller University of Jena, Jena, Germany. Electronic address: mq.koch@gmx.de.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Eckardt', 'Affiliation': 'Department of Sport and Movement Science, Institute of Sport Science, Carl von Ossietzky University of Oldenburg, Oldenburg, Germany; Department for Exercise & Health, Institute of Sport Science, Leibniz University Hannover, Hannover, Germany. Electronic address: nils.eckardt@uni-oldenburg.de.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Zech', 'Affiliation': 'Institute of Sports Science, Friedrich Schiller University of Jena, Jena, Germany. Electronic address: astrid.zech@uni-jena.de.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hamacher', 'Affiliation': 'Institute of Sports Science, Friedrich Schiller University of Jena, Jena, Germany. Electronic address: daniel.hamacher@uni-jena.de.'}]",Gait & posture,['10.1016/j.gaitpost.2020.05.040']
2980,32559656,Can theory of mind be improved? Positive expectations cause better theory of mind performance in a community sample.,"BACKGROUND AND OBJECTIVES


Theory of Mind (ToM) deficits are present in several mental disorders and closely related to problems in social functioning and lower quality of life. While several trainings are aimed at improving ToM performance, it is unknown whether positive expectations on a persons' ToM performance might cause better ToM achievement.
METHODS


Participants (n = 131) first completed a mock ToM test and were then randomly assigned to either receive standardized positive, negative or no feedback on their ToM performance. Secondly, their expectations on their own ToM performance were assessed. Thirdly, ToM was assessed using the Movie Task for the Assessment of Social Cognition (MASC).
RESULTS


Participants who received positive feedback resulted in positive expectations on their ToM performance and showed enhanced ToM performance, whereas negative feedback did not lead to negative expectations and negative expectations did not affect a change in ToM performance.
LIMITATIONS


In the present exploratory study, the effect of positive expectations on ToM performance was assessed in a community sample. Thus, the study should be replicated in a clinical sample for more in-depth results.
CONCLUSIONS


ToM performance could be enhanced by inducing positive expectations on one's ToM performance, whereas negative feedback had no effect. The present study suggest that interventions that focus on strengthening positive expectations on one's ToM performance could enhance the efficacy of present ToM training methods.",2020,"RESULTS


Participants who received positive feedback resulted in positive expectations on their ToM performance and showed enhanced ToM performance, whereas negative feedback did not lead to negative expectations and negative expectations did not affect a change in ToM performance.
",['Participants (n\xa0'],"['standardized positive, negative or no feedback on their ToM performance']","['Movie Task for the Assessment of Social Cognition (MASC', 'enhanced ToM performance', 'ToM performance']",[],"[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0935573', 'cui_str': 'Theory of Mind'}]","[{'cui': 'C0681495', 'cui_str': 'Movies'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0935573', 'cui_str': 'Theory of Mind'}]",131.0,0.0319971,"RESULTS


Participants who received positive feedback resulted in positive expectations on their ToM performance and showed enhanced ToM performance, whereas negative feedback did not lead to negative expectations and negative expectations did not affect a change in ToM performance.
","[{'ForeName': 'Laura M-L', 'Initials': 'LM', 'LastName': 'Dorn', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps-University, Marburg, Germany. Electronic address: laura.dorn@staff.uni-marburg.de.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Rief', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps-University, Marburg, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Mehl', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Philipps-University, Marburg, Germany; Department of Social Work and Health, Frankfurt University of Applied Sciences, Germany.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101577']
2981,32559669,A novel digital health intervention to improve patient engagement to stimulants in adult ADHD in the primary care setting: Preliminary findings from an open label study.,"AIMS


We piloted the effectiveness and acceptability of a novel text messaging-based (SMS) digital health intervention aimed at addressing the previously documented poor rate of patient engagement in stimulant treatment in the primary care setting.
METHODS


117 adults ages 18-55 from primary care and psychiatric practices who were prescribed a stimulant medication for ADHD treatment received the SMS intervention. Comparators were age-, race-, and sex-matched patients from the same health care organization's electronic medical record who had been prescribed stimulant medications over a similar time period. Using documented prescription records, we determined whether patients had timely prescription refills.
RESULTS


Ninety-six percent (N = 112) of participants completed our a priori metric of patient engagement consisting of 37 days of the SMS program. Eighty-one percent of participants refilled their index prescriptions in a timely manner compared to only 36% of patients receiving treatment as usual (OR=7.54, 95% CI: 4.46, 12.77; p<0.001). We found no significant interaction between prescribing source (non-psychiatry vs. psychiatry) and intervention group (SMS vs. treatment as usual).
CONCLUSIONS


These data suggest that an ADHD-centric, digital health intervention using text messaging significantly improves patient engagement in stimulant treatment in adults with ADHD.",2020,"We found no significant interaction between prescribing source (non-psychiatry vs. psychiatry) and intervention group (SMS vs. treatment as usual).
","[""Comparators were age-, race-, and sex-matched patients from the same health care organization's electronic medical record who had been prescribed stimulant medications over a similar time period"", 'adults with ADHD', 'adult ADHD in the primary care setting', '117 adults ages 18-55 from primary care and psychiatric practices who were prescribed a stimulant medication for ADHD treatment received the']","['SMS intervention', 'digital health intervention', 'novel text messaging-based (SMS) digital health intervention']",['patient engagement'],"[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C3508152', 'cui_str': 'Patient Engagement'}]",117.0,0.0801889,"We found no significant interaction between prescribing source (non-psychiatry vs. psychiatry) and intervention group (SMS vs. treatment as usual).
","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Biederman', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, MA, USA. Electronic address: jbiederman@partners.org.'}, {'ForeName': 'Ronna', 'Initials': 'R', 'LastName': 'Fried', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'DiSalvo', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Driscoll', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Green', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Itai', 'Initials': 'I', 'LastName': 'Biederman', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'K Yvonne', 'Initials': 'KY', 'LastName': 'Woodworth', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Stephen V', 'Initials': 'SV', 'LastName': 'Faraone', 'Affiliation': 'Departments of Psychiatry and of Neuroscience and Physiology, SUNY Upstate Medical University, Syracuse, NY, USA.'}]",Psychiatry research,['10.1016/j.psychres.2020.113158']
2982,32559794,Preoperative Fasting Abbreviation and its Effects on Postoperative Nausea and Vomiting Incidence in Gynecological Surgery Patients.,"OBJECTIVE


To investigate the effects of preoperative fasting abbreviation with a carbohydrate and protein-enriched solution, on postoperative nausea and vomiting (PONV) incidence in gynecological surgery patients, a population naturally at risk for such unpleasant episodes.
METHODS


The present prospective double-blind randomized study was performed at The Hospital Municipal e Maternidade Dr. Odelmo Leão Carneiro (HMMOLC, in the Portuguese acronym), in Uberlândia, state of Minas Gerais, Brazil, in partnership with the Gynecology Department of the Universidade Federal de São Paulo (UNIFESP), approved by the Human Research Ethics Committee of UNIFESP and the board of HMMOLC, and included in the Brazil Platform and in the Brazilian Clinical Trial Registry. After signing the consent form, 80 women, who were submitted to gynecological surgery in the period from January to June 2016, were randomized into 2 groups: control group ( n  = 42) and juice group ( n  = 38). They received, respectively, 200 mL of inert solution or liquid enriched with carbohydrate and protein 4 hours presurgery. The incidence, frequency and intensity of PONV were studied using the Visual Analogue Scale (VAS), with statistical analysis performed by the software IBM SPSS Statistics for Windows, Version 20.0 (IBM Corp, Armonk, NY, USA).
RESULTS


The incidence of nausea and vomiting was lower than in the literature, to this population, with 18.9% (14/74) for the control group and 10.8% (8/74) for the juice group, respectively, with no statistically significant difference between the groups.
CONCLUSION


The incidence of nausea and vomiting was lower than in the literature, but it cannot be said that this is due to the abbreviation of fasting. It can provide greater comfort, with the possibility of PONV prevention in patients at risk for these episodes.",2020,"The incidence, frequency and intensity of PONV were studied using the Visual Analogue Scale (VAS), with statistical analysis performed by the software IBM SPSS Statistics for Windows, Version 20.0 (IBM Corp, Armonk, NY, USA).
","['Hospital Municipal e Maternidade Dr. Odelmo Leão Carneiro (HMMOLC, in the Portuguese acronym), in Uberlândia, state of Minas Gerais, Brazil, in partnership with the Gynecology Department of the Universidade Federal de São Paulo (UNIFESP', '80 women, who were submitted to gynecological surgery in the period from January to June 2016', 'Gynecological Surgery Patients', 'gynecological surgery patients, a population naturally at risk for such unpleasant episodes']","['inert solution or liquid enriched with carbohydrate and protein 4\u2009hours presurgery', 'preoperative fasting abbreviation with a carbohydrate and protein-enriched solution', 'control group ( n \u2009=\u200942) and juice group']","['incidence, frequency and intensity of PONV', 'nausea and vomiting', 'Postoperative Nausea and Vomiting Incidence', 'Visual Analogue Scale (VAS', 'postoperative nausea and vomiting (PONV) incidence']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0032730', 'cui_str': 'Portuguese'}, {'cui': 'C1956259', 'cui_str': 'Acronyms'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0587481', 'cui_str': 'Gynecology department'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]","[{'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1292426', 'cui_str': '4 hours'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0000723', 'cui_str': 'Abbreviation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.0588202,"The incidence, frequency and intensity of PONV were studied using the Visual Analogue Scale (VAS), with statistical analysis performed by the software IBM SPSS Statistics for Windows, Version 20.0 (IBM Corp, Armonk, NY, USA).
","[{'ForeName': 'Gisele Vissoci', 'Initials': 'GV', 'LastName': 'Marquini', 'Affiliation': 'Department of Gynecology, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Francisco Edes da Silva', 'Initials': 'FEDS', 'LastName': 'Pinheiro', 'Affiliation': 'Department of Gynecology, Hospital Municipal Maternidade Dr. Odelmo Leão Carneiro, Uberlândia, MG, Brazil.'}, {'ForeName': 'Alfredo Urbano da Costa', 'Initials': 'AUDC', 'LastName': 'Vieira', 'Affiliation': 'Department of Gynecology, Hospital Municipal Maternidade Dr. Odelmo Leão Carneiro, Uberlândia, MG, Brazil.'}, {'ForeName': 'Rogério Melo da Costa', 'Initials': 'RMDC', 'LastName': 'Pinto', 'Affiliation': 'Faculty of Mathematics, Universidade Federal de Uberlândia, Uberlândia, MG, Brazil.'}, {'ForeName': 'Maria Gabriela Baumgarten Kuster', 'Initials': 'MGBK', 'LastName': 'Uyeda', 'Affiliation': 'Department of Gynecology, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Manoel João Batista Castello', 'Initials': 'MJBC', 'LastName': 'Girão', 'Affiliation': 'Department of Gynecology, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Marair Gracio Ferreira', 'Initials': 'MGF', 'LastName': 'Sartori', 'Affiliation': 'Department of Gynecology, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}]",Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia,['10.1055/s-0040-1712994']
2983,31961711,Effects of combined histamine H 1  and H 2  receptor blockade on hemodynamic responses to dynamic exercise in males with high-normal blood pressure.,"While postexercise hypotension is associated with histamine H 1  and H 2  receptor-mediated postexercise vasodilation, effects of histaminergic vasodilation on blood pressure (BP) in response to dynamic exercise are not known. Thus, in 20 recreationally active male participants (10 normotensive and 10 with high-normal BP) we examined the effects of histamine H 1  and H 2  receptor blockade on cardiac output (CO), mean atrial pressure (MAP), aortic stiffness (AoStiff), and total vascular conductance (TVC) at rest and during progressive cycling exercise. Compared with the normotensive group, MAP, CO, and AoStiff were higher in the high-normal group before and after the blockade at rest, while TVC was similar. At the 40% workload, the blockade significantly increased MAP in both groups, while no difference was found in the TVC. CO was higher in the high-normal group than the normotensive group in both conditions. At the 60% workload, the blockade substantially increased MAP and decreased TVC in the normotensive group, while there were no changes in the high-normal group. A similar CO response pattern was observed at the 60% workload. These findings suggest that the mechanism eliciting an exaggerated BP response to exercise in the high-normal group may be partially due to the inability of histamine receptors.  Novelty  Males with high-normal BP had an exaggerated BP response to exercise. The overactive BP response is known due to an increase in peripheral vasoconstriction. Increase in peripheral vasoconstriction is partially due to inability of histamine receptors.",2020,"At the 40% workload, the blockade significantly increased MAP in both groups, while no difference was found in the TVC.","['males with high-normal blood pressure', '20 recreationally active male participants (10 normotensive and 10 with high-normal BP', 'Males with high-normal BP']","['histamine H 1  and H 2  receptor blockade', 'combined histamine H 1  and H 2  receptor blockade']","['cardiac output (CO), mean atrial pressure (MAP), aortic stiffness (AoStiff), and total vascular conductance (TVC) at rest and during progressive cycling exercise', 'exaggerated BP response', 'MAP, CO, and AoStiff', 'TVC', 'MAP', 'blood pressure (BP', 'Novelty', 'CO', 'CO response pattern', 'MAP and decreased TVC', 'overactive BP response']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0019588', 'cui_str': 'Histamine'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C3854604', 'cui_str': 'Mean atrial pressure'}, {'cui': 'C3178782', 'cui_str': 'Aortic Stiffness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442801', 'cui_str': 'Exaggerated'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0443272', 'cui_str': 'Overactive'}]",10.0,0.0443588,"At the 40% workload, the blockade significantly increased MAP in both groups, while no difference was found in the TVC.","[{'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Naylor', 'Affiliation': 'Department of Kinesiology, California Baptist University, Riverside, CA 92504, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Shariffi', 'Affiliation': 'Department of Kinesiology, California Baptist University, Riverside, CA 92504, USA.'}, {'ForeName': 'Trevor L', 'Initials': 'TL', 'LastName': 'Gillum', 'Affiliation': 'Department of Kinesiology, California Baptist University, Riverside, CA 92504, USA.'}, {'ForeName': 'Boyer', 'Initials': 'B', 'LastName': 'William', 'Affiliation': 'Department of Kinesiology, California Baptist University, Riverside, CA 92504, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Sullivan', 'Affiliation': 'Department of Kinesiology, California Baptist University, Riverside, CA 92504, USA.'}, {'ForeName': 'Jong-Kyung', 'Initials': 'JK', 'LastName': 'Kim', 'Affiliation': 'Department of Kinesiology, California Baptist University, Riverside, CA 92504, USA.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0645']
2984,32204780,Scoping Review of School-to-Work Transition for Youth With Intellectual Disabilities: A Practice Gap.,"IMPORTANCE


Youth with intellectual disabilities (ID) have persistently poor work outcomes. Occupational therapy can support school-to-work transition but is underrepresented in transition practice.
OBJECTIVE


To identify and describe interventions within the scope of occupational therapy for youth with ID who are transitioning from school to work.
DATA SOURCES


MEDLINE, ERIC, PsycINFO, and CINAHL were searched, and hand searching was performed in relevant peer-reviewed journals.
STUDY SELECTION AND DATA COLLECTION


Included were peer-reviewed, English-language articles published from 2004 to 2017 describing studies focused on youth with ID with no significant co-occurring physical diagnoses who were transitioning from U.S.-based school settings to paid employment. Data extraction was managed using Google Drive. Data were organized on extraction sheets by trained reviewers. The quality of each study was assessed using questions adapted from the Critical Appraisal Skills Program checklist.
FINDINGS


A total of 35 articles were included, 7 of which used randomized controlled designs. All articles described interventions aligned with the Occupational Therapy Practice Framework: Domain and Process (3rd ed.), but specific mention of occupational therapy was notably absent from the literature. Interventions had little and generally low-level evidence supporting their use.
CONCLUSIONS AND RELEVANCE


Significant and concerning gaps exist in the literature on school-to-work transition for youth with ID, likely impeding evidence-based practice. No included article mentioned occupational therapy or had a contributor who was an occupational therapy practitioner. Practitioners should advocate for occupational therapy's role in transition and contribute reports of occupational therapy transition services for youth with ID to the literature.
WHAT THIS ARTICLE ADDS


This study demonstrates that occupational therapy is poorly represented in literature describing transition services for youth with ID. Although the articles described interventions within the occupational therapy domain, these interventions were not provided by occupational therapy practitioners and did not have a strong evidence base.",2020,"Practitioners should advocate for occupational therapy's role in transition and contribute reports of occupational therapy transition services for youth with ID to the literature.
","['youth with ID who are transitioning from school to work', 'Youth with intellectual disabilities (ID', 'youth with ID', 'Youth With Intellectual Disabilities', 'A total of 35 articles', 'Included were peer-reviewed, English-language articles published from 2004 to 2017 describing studies focused on youth with ID with no significant co-occurring physical diagnoses who were transitioning from U.S.-based school settings to paid employment']",['Occupational therapy'],[],"[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030768', 'cui_str': 'Peer review'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0034037', 'cui_str': 'Publishing'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1320371', 'cui_str': 'In paid employment'}]","[{'cui': 'C1318464', 'cui_str': 'Occupational therapy'}]",[],35.0,0.0309169,"Practitioners should advocate for occupational therapy's role in transition and contribute reports of occupational therapy transition services for youth with ID to the literature.
","[{'ForeName': 'Taryn', 'Initials': 'T', 'LastName': 'Rosner', 'Affiliation': 'Taryn Rosner, OTD, OTR/L, is Director of Occupational Therapy, MOCO Movement Center, Kensington, MD; taryn@mocomc.com.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Grasso', 'Affiliation': 'Anna Grasso, MS, OTR/L, CAPS, is Academic Fieldwork Coordinator and Assistant Professor, Salus University, Elkins Park, PA.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Scott-Cole', 'Affiliation': 'Louise Scott-Cole, MSOT, OTR/L, is Occupational Therapist, Wake County Public School District, Cary, NC.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Villalobos', 'Affiliation': 'Alison Villalobos, OTD, OTR/L, is Occupational Therapist, SenseAbilities Speech and Occupational Therapy Services, Riverside, CA.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Mulcahey', 'Affiliation': 'MJ Mulcahey, PhD, OTR/L, FASIA, is Professor of Occupational Therapy and Director, Center for Outcomes and Measurement, Jefferson College of Rehabilitation Sciences, Thomas Jefferson University, Philadelphia, PA.'}]",The American journal of occupational therapy : official publication of the American Occupational Therapy Association,['10.5014/ajot.2019.035220']
2985,32297407,Pomalidomide-bortezomib-dexamethasone in relapsed or refractory multiple myeloma: Japanese subset analysis of OPTIMISMM.,"In the phase 3 OPTIMISMM trial, pomalidomide, bortezomib and dexamethasone (PVd) significantly improved the progression-free survival (PFS) and the overall response rate (ORR) vs bortezomib and dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma. All patients were previously treated with lenalidomide (70% refractory to lenalidomide) and had received one to three prior regimens. Here we report the first efficacy and safety analysis of PVd vs Vd in Japanese patients with relapsed or refractory multiple myeloma. Seventeen patients enrolled in the OPTIMISMM trial in Japan. With a median follow-up of 14.8 months, the median PFS was 17.6 months with PVd (n = 12) vs 4.4 months with Vd (n = 5), and the ORR was 100% vs 60.0%, respectively. The safety profile was as expected for PVd. Toxicities were managed with dose reductions and interruptions, and no patients discontinued PVd due to treatment-emergent adverse events. These results are consistent with those in the overall OPTIMISMM patient population and confirm the clinical benefit of PVd in Japanese patients.",2020,"Toxicities were managed with dose reductions and interruptions, and no patients discontinued PVd due to treatment-emergent adverse events.","['patients with relapsed or refractory multiple myeloma', 'relapsed or refractory multiple myeloma', 'Seventeen patients enrolled in the OPTIMISMM trial in Japan', 'Japanese patients with relapsed or refractory multiple myeloma', 'Japanese patients']","['PVd', 'bortezomib and dexamethasone', 'lenalidomide', 'Pomalidomide-bortezomib-dexamethasone', 'pomalidomide, bortezomib and dexamethasone (PVd']","['Toxicities', 'ORR', 'progression-free survival (PFS) and the overall response rate (ORR', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C2347624', 'cui_str': 'pomalidomide'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",17.0,0.0334038,"Toxicities were managed with dose reductions and interruptions, and no patients discontinued PVd due to treatment-emergent adverse events.","[{'ForeName': 'Kazutaka', 'Initials': 'K', 'LastName': 'Sunami', 'Affiliation': 'Department of Hematology, National Hospital Organization Okayama Medical Center, Okayama, Japan.'}, {'ForeName': 'Kosei', 'Initials': 'K', 'LastName': 'Matsue', 'Affiliation': 'Department of Hematology, Kameda Medical Center, Chiba, Japan.'}, {'ForeName': 'Kenshi', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'Department of Hematology, Japanese Red Cross Medical Center, Tokyo, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Takezako', 'Affiliation': 'Department of Hematology, National Hospital Organization Disaster Medical Center, Tokyo, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Shinagawa', 'Affiliation': 'Department of Hemato-Oncology, Hitachi General Hospital, Ibaraki, Japan.'}, {'ForeName': 'Sanae', 'Initials': 'S', 'LastName': 'Sakurai', 'Affiliation': 'Department of Clinical Research & Development Study, Celgene KK, a Bristol-Myers Squibb Company, Tokyo, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Tamakoshi', 'Affiliation': 'Department of Clinical Research & Development Study, Celgene KK, a Bristol-Myers Squibb Company, Tokyo, Japan.'}, {'ForeName': 'Tsvetan', 'Initials': 'T', 'LastName': 'Biyukov', 'Affiliation': 'Department of Clinical R&D Management, Celgene International Sàrl, a Bristol-Myers Squibb Company, Boudry, Switzerland.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Peluso', 'Affiliation': 'Department of Clinical R&D Management, Celgene International Sàrl, a Bristol-Myers Squibb Company, Boudry, Switzerland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Richardson', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}]",Cancer science,['10.1111/cas.14415']
2986,31470947,Long-term effects of mitomycin-C on residual aberration and optical quality after photorefractive keratectomy in eyes with low to moderate myopia.,,2019,,['eyes with low to moderate myopia'],['mitomycin-C'],['residual aberration and optical quality'],"[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}]","[{'cui': 'C0002475', 'cui_str': 'Mitomycin'}]","[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",,0.0341336,,"[{'ForeName': 'Seyed Farzad', 'Initials': 'SF', 'LastName': 'Mohammadi', 'Affiliation': ''}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Abdolahinia', 'Affiliation': ''}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Ashrafi', 'Affiliation': ''}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Heydari', 'Affiliation': ''}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Jamali', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1016/j.jcrs.2019.04.040']
2987,32559601,Cardiovascular responses to pelvic floor muscle contraction in healthy women: Prospective study.,"OBJECTIVE


Analyze the acute heart rate and blood pressure responses to two protocols of pelvic floor muscles contractions in premenopausal and postmenopausal women.
METHODS


Fifty-four women without pelvic floor muscles disorders were eligible and allocated into two groups: premenopausal and postmenopausal. The groups underwent two protocols and the pelvic floor muscle endurance, heart rate, and blood pressure values were monitored. Both protocols included 10 pelvic floor muscles contractions; one series contained contractions lasting 5 s with 5 s of rest between each contraction and the other series contained contractions lasting 10 s with 10 s of rest.
RESULTS


In both groups, there was a significant increase in the heart rate during pelvic floor muscles contractions (premenopausal: 71.0 ± 7.3 and 80.3 ± 7.7; postmenopausal: 65.4 ± 6.6 and 73.6 ± 6.6, at rest and contractions peak, respectively) and in systolic blood pressure immediately after the contractions. The observed values during exercise returned to basal values seconds after the contractions. A positive correlation between heart rate and vaginal squeeze pressure (r = 0.45, p = 0.0007 and r = 0.48, p = 0.0003, 5- and 10-s series, respectively) was observed.
CONCLUSION


The proposed protocol of isometric pelvic floor muscles contractions caused an increase in heart rate and blood pressure within the normal range and might not represent a cardiovascular risk for healthy postmenopausal women without urinary incontinence and without cardiovascular dysfunctions.",2020,The proposed protocol of isometric pelvic floor muscles contractions caused an increase in heart rate and blood pressure within the normal range and might not represent a cardiovascular risk for healthy postmenopausal women without urinary incontinence and without cardiovascular dysfunctions.,"['premenopausal and postmenopausal women', 'healthy women', 'healthy postmenopausal women without urinary incontinence and without cardiovascular dysfunctions', 'Fifty-four women without pelvic floor muscles disorders were eligible and allocated into two groups: premenopausal and postmenopausal']",['pelvic floor muscles contractions'],"['heart rate and blood pressure', 'pelvic floor muscle endurance, heart rate, and blood pressure values', 'heart rate', 'Cardiovascular responses', 'systolic blood pressure', 'heart rate and vaginal squeeze pressure']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026848', 'cui_str': 'Disorder of muscle'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0413258', 'cui_str': 'Barotrauma of descent'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",54.0,0.0281104,The proposed protocol of isometric pelvic floor muscles contractions caused an increase in heart rate and blood pressure within the normal range and might not represent a cardiovascular risk for healthy postmenopausal women without urinary incontinence and without cardiovascular dysfunctions.,"[{'ForeName': 'Alana Maria G', 'Initials': 'AMG', 'LastName': 'Bastos', 'Affiliation': ""Women's Health Research Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.""}, {'ForeName': 'Aparecida M', 'Initials': 'AM', 'LastName': 'Catai', 'Affiliation': 'Cardiovascular Physical Therapy Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.'}, {'ForeName': 'Soraia P', 'Initials': 'SP', 'LastName': 'Jürgensen', 'Affiliation': ""Women's Health Research Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.""}, {'ForeName': 'Grasiela N', 'Initials': 'GN', 'LastName': 'Correia', 'Affiliation': ""Women's Health Research Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.""}, {'ForeName': 'Vanessa S', 'Initials': 'VS', 'LastName': 'Pereira-Baldon', 'Affiliation': ""Women's Health Research Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.""}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Perseguini', 'Affiliation': 'Cardiovascular Physical Therapy Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Borghi-Silva', 'Affiliation': 'Cardiovascular Physical Therapy Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Driusso', 'Affiliation': ""Women's Health Research Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil. Electronic address: pdriusso@ufscar.br.""}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.05.050']
2988,32559716,A randomized controlled trial of digital cognitive behavioral therapy for insomnia in pregnant women.,"OBJECTIVE


Despite high rates of prenatal insomnia, efficacious treatment options for this population are quite limited. Early evidence from randomized controlled trials (RCTs) support the efficacy of face-to-face cognitive-behavioral therapy for insomnia (CBTI) for prenatal insomnia. Yet, as many patients are unable to access this specialist-driven care, a critical need exists to increase its accessibility. This RCT examined the efficacy internet-based digital CBTI in pregnant women with insomnia.
METHODS


Single-site RCT. A total of 91 pregnant women (29.03 ± 4.16 years) nearing/entering the third trimester who screened positive for clinical insomnia on the Insomnia Severity Index (ISI) were randomized to digital CBTI or digital sleep education control. The ISI, Pittsburgh Sleep Quality Index (PSQI), Edinburgh Postnatal Depression Scale (EPDS), and Pre-Sleep Arousal Scale's Cognitive factor (PSAS-C) served as study outcomes, which were collected before treatment and after treatment during pregnancy, then six weeks after childbirth.
RESULTS


From pre to posttreatment, CBTI patients reported reductions in ISI (-4.91 points, p < 0.001) and PSQI (-2.98 points, p < 0.001) and increases in nightly sleep duration by 32 min (p = 0.008). Sleep symptoms did not change during pregnancy in the control group. After childbirth, CBTI patients, relative to controls, slept longer by 40 min per night (p = 0.01) and reported better sleep maintenance. No pre or postnatal treatment effects on depression or cognitive arousal were observed.
CONCLUSIONS


Digital CBTI improves sleep quality and sleep duration during pregnancy and after childbirth. To better optimize outcomes, CBTI should be tailored to meet the changing needs of women as the progress through pregnancy and early parenting. NAME: Insomnia and Rumination in Late Pregnancy and the Risk for Postpartum Depression. URL: clinicaltrials.gov. Registration: NCT03596879.",2020,"From pre to posttreatment, CBTI patients reported reductions in ISI (-4.91 points, p < 0.001) and PSQI (-2.98 points, p < 0.001) and increases in nightly sleep duration by 32 min (p = 0.008).","['insomnia (CBTI) for prenatal insomnia', 'pregnant women with insomnia', '91 pregnant women (29.03\xa0±\xa04.16 years) nearing/entering the third trimester who screened positive for clinical insomnia on the Insomnia Severity Index (ISI', 'pregnant women']","['Digital CBTI', 'digital CBTI or digital sleep education control', 'digital cognitive behavioral therapy', 'face-to-face cognitive-behavioral therapy', 'NAME']","['nightly sleep duration', 'PSQI', 'sleep quality and sleep duration', 'sleep maintenance', 'ISI', 'depression or cognitive arousal', ""ISI, Pittsburgh Sleep Quality Index (PSQI), Edinburgh Postnatal Depression Scale (EPDS), and Pre-Sleep Arousal Scale's Cognitive factor (PSAS-C"", 'Sleep symptoms', 'Insomnia and Rumination in Late Pregnancy and the Risk for Postpartum Depression']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]","[{'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}]",91.0,0.126542,"From pre to posttreatment, CBTI patients reported reductions in ISI (-4.91 points, p < 0.001) and PSQI (-2.98 points, p < 0.001) and increases in nightly sleep duration by 32 min (p = 0.008).","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kalmbach', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA. Electronic address: dkalmba1@hfhs.org.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Cheng', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Louise M', 'Initials': 'LM', 'LastName': ""O'Brien"", 'Affiliation': 'Departments of Obstetrics & Gynecology and Neurology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Leslie M', 'Initials': 'LM', 'LastName': 'Swanson', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Roopina', 'Initials': 'R', 'LastName': 'Sangha', 'Affiliation': 'Department of Obstetrics & Gynecology, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Srijan', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Guille', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cuamatzi-Castelan', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Alasdair L', 'Initials': 'AL', 'LastName': 'Henry', 'Affiliation': 'Big Health Inc, San Francisco, CA, USA; Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Roth', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Drake', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA.'}]",Sleep medicine,['10.1016/j.sleep.2020.03.016']
2989,32559734,"Effects of low fructose diet on glycemic control, lipid profile and systemic inflammation in patients with type 2 diabetes: A single-blind randomized controlled trial.","BACKGROUND AND AIM


Type 2 diabetes is one of the global epidemic disorders, which causes many side effects on the body. Fructose is a lipogenic monosaccharide. Recent studies have reported the adverse effects of this carbohydrate on diabetes. This study aimed to evaluate the clinical efficacy of a low-fructose diet on the metabolic alterations in patients with type 2 diabetes.
METHODS


This study was a randomized, single-blind clinical trial on 50 patients with type 2 diabetes. Participants randomly allocated to two groups, to receive either diabetic-diet or diabetic-diet with low-fructose for 8-weeks. Anthropometric measurements, systolic blood pressure (SBP), Diastolic blood pressure (DBP) and metabolic factors were assessed at baseline and the end of the trial.
RESULTS


At the end of trial, reduction in body weight, waist circumference, and blood pressure were not significant except for DBP (P = 0.013). Statistical analysis showed that low-fructose diet compared to control group significantly declined fasting blood glucose (FBG), Hemoglobin A1c (HbA1c), Triglyceride (TG), high-density lipoprotein-cholesterol (HDL-C) and high-sensitivity C-reactive protein (hs-CRP) (P = 0.015, P = 0.001, P=<0.0001, P= <0.0001 and P= <0.0001 respectively).
CONCLUSION


Our results showed that eight weeks of low-fructose diet results in a significant improvement in FBG, HbA1c, TG, HDL-C and hs-CRP in patients with type 2 diabetes.",2020,"At the end of trial, reduction in body weight, waist circumference, and blood pressure were not significant except for DBP (P = 0.013).","['50 patients with type 2 diabetes', 'patients with type 2 diabetes']","['diabetic-diet or diabetic-diet with low-fructose for 8-weeks', 'low-fructose diet', 'Fructose', 'low fructose diet']","['fasting blood glucose (FBG), Hemoglobin A1c (HbA1c), Triglyceride (TG), high-density lipoprotein-cholesterol (HDL-C) and high-sensitivity C-reactive protein (hs-CRP', 'Anthropometric measurements, systolic blood pressure (SBP), Diastolic blood pressure (DBP) and metabolic factors', 'glycemic control, lipid profile and systemic inflammation', 'body weight, waist circumference, and blood pressure', 'metabolic alterations', 'FBG, HbA1c, TG, HDL-C and hs-CRP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0011878', 'cui_str': 'Diabetic diet'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0452314', 'cui_str': 'Low fructose diet'}]","[{'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",50.0,0.074236,"At the end of trial, reduction in body weight, waist circumference, and blood pressure were not significant except for DBP (P = 0.013).","[{'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Jalilvand', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, ShahidBeheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Vahideh', 'Initials': 'V', 'LastName': 'Behrouz', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, ShahidBeheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Nikpayam', 'Affiliation': 'Student Research Committee, Tabriz University of Medical Science, Tabriz, Iran; Department of Clinical Nutrition, Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Golbon', 'Initials': 'G', 'LastName': 'Sohrab', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, ShahidBeheshti University of Medical Sciences, Tehran, Iran. Electronic address: golbonsohrab@yahoo.com.'}, {'ForeName': 'Azita', 'Initials': 'A', 'LastName': 'Hekmatdoost', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, ShahidBeheshti University of Medical Sciences, Tehran, Iran.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.04.003']
2990,32559735,Improving clinical outcomes of diabetic foot ulcers by the 3-month self- and family management support programs in Indonesia: A randomized controlled trial study.,"BACKGROUND AND AIMS


Diabetic foot ulcers are the leading cause of lower extremity amputations, which require more effective prevention. Even though previous nursing studies on diabetic foot ulcers have been well performed, programs implementing self- and family management are limited and even underexplored. Therefore, the purpose of the study was to investigate the effect of 3-month self- and family management support programs on clinical outcomes among Indonesians with diabetic foot ulcers.
METHOD


The randomized controlled trial design was used to answer the research question of the study. A total of 56 eligible participants were enrolled, with 27 in the experimental group and 29 in the control group. The experimental group received self- and family management support programs for three months. Meanwhile, the control group received usual care. Descriptive statistics, multivariate analysis of variance, and Generalized Estimating Equations were used to analyze the data. The significance level was considered at .05 for hypothesis testing.
RESULTS


The study showed that there were statistically significant improvements in self-management, family supports, hemoglobin A1c, and wound size after implemented the programs for three months (p < .05).
CONCLUSIONS


With regard to the result of the study, implementing the 3-month self- and family management support programs improves the patients' and families' abilities to perform diabetic foot ulcer care at home.",2020,"The study showed that there were statistically significant improvements in self-management, family supports, hemoglobin A1c, and wound size after implemented the programs for three months (p < .05).
","['A total of 56 eligible participants were enrolled, with 27 in the experimental group and 29 in the control group', 'Indonesia', 'Indonesians with diabetic foot ulcers']","['usual care', 'self- and family management support programs']","['self-management, family supports, hemoglobin A1c, and wound size']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C0021248', 'cui_str': 'Indonesian language'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0150232', 'cui_str': 'Family support'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",56.0,0.0239313,"The study showed that there were statistically significant improvements in self-management, family supports, hemoglobin A1c, and wound size after implemented the programs for three months (p < .05).
","[{'ForeName': 'Sumarno Adi', 'Initials': 'SA', 'LastName': 'Subrata', 'Affiliation': 'Ramathibodi School of Nursing, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand; Department of Nursing and Wound Research Center, Faculty of Health Sciences, Universitas Muhammadiyah Magelang, Indonesia.'}, {'ForeName': 'Rutja', 'Initials': 'R', 'LastName': 'Phuphaibul', 'Affiliation': 'Ramathibodi School of Nursing, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand. Electronic address: ruja.phu@mahidol.ac.th.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Grey', 'Affiliation': 'Yale University School of Nursing, United States.'}, {'ForeName': 'Apinya', 'Initials': 'A', 'LastName': 'Siripitayakunkit', 'Affiliation': 'Ramathibodi School of Nursing, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand.'}, {'ForeName': 'Noppawan', 'Initials': 'N', 'LastName': 'Piaseu', 'Affiliation': 'Ramathibodi School of Nursing, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.05.028']
2991,32559759,Short-term nicotine deprivation alters dorsal anterior cingulate glutamate concentration and concomitant cingulate-cortical functional connectivity.,"Most cigarette smokers who wish to quit too often relapse within the first few days of abstinence, primarily due to the aversive aspects of the nicotine withdrawal syndrome (NWS), which remains poorly understood. Considerable research has suggested that the dorsal anterior cingulate cortex (dACC) plays a key role in nicotine dependence, with its functional connections between other brain regions altered as a function of trait addiction and state withdrawal. The flow of information between dACC and fronto-striatal regions is secured through different pathways, the vast majority of which are glutamatergic. As such, we investigated dACC activity using resting state functional connectivity (rsFC) with functional magnetic resonance imaging (fMRI) and glutamate (Glu) concentration with magnetic resonance spectroscopy (MRS). We also investigated the changes in adenosine levels in plasma during withdrawal as a surrogate for brain adenosine, which plays a role in fine-tuning synaptic glutamate transmission. Using a double-blind, placebo-controlled, randomized crossover design, nontreatment seeking smoking participants (N = 30) completed two imaging sessions, one while nicotine sated and another after 36 h nicotine abstinence. We observed reduced dACC Glu (P = 0.029) along with a significant reduction in plasma adenosine (P = 0.03) and adenosine monophosphate (AMP; P < 0.0001) concentrations during nicotine withdrawal in comparison with nicotine sated state. This withdrawal state manipulation also led to an increase in rsFC strength (P < 0.05) between dACC and several frontal cortical regions, including left superior frontal gyrus (LSFG), and right middle frontal gyrus (RMFG). Moreover, the state-trait changes in dACC Glu and rsFC strength between the dACC and both SFG and MFG were positively correlated (P = 0.012, and P = 0.007, respectively). Finally, the change in circuit strength between dACC and LSFG was negatively correlated with the change in withdrawal symptom manifestations as measured by the Wisconsin Smoking Withdrawal Scale (P = 0.04) and Tobacco Craving Questionnaire (P = 0.014). These multimodal imaging-behavioral findings reveal the complex cascade of changes induced by acute nicotine deprivation and call for further investigation into the potential utility of adenosine- and glutamate-signaling as novel therapeutic targets to treat the NWS.",2020,"This withdrawal state manipulation also led to an increase in rsFC strength (P < 0.05) between dACC and several frontal cortical regions, including left superior frontal gyrus (LSFG), and right middle frontal gyrus (RMFG).",['nontreatment seeking smoking participants (N\u2009=\u200930) completed two'],"['placebo', 'Short-term nicotine deprivation', 'imaging sessions, one while nicotine sated and another after 36\u2009h nicotine abstinence', 'functional magnetic resonance imaging (fMRI) and glutamate (Glu) concentration with magnetic resonance spectroscopy (MRS']","['plasma adenosine', 'left superior frontal gyrus (LSFG), and right middle frontal gyrus (RMFG', 'Wisconsin Smoking Withdrawal Scale', 'dACC Glu', 'dACC Glu and rsFC strength', 'rsFC strength', 'withdrawal symptom manifestations', 'circuit strength', 'Tobacco Craving Questionnaire']","[{'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0001443', 'cui_str': 'Adenosine'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0152296', 'cui_str': 'Structure of superior frontal gyrus'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0152297', 'cui_str': 'Structure of middle frontal gyrus'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0275209,"This withdrawal state manipulation also led to an increase in rsFC strength (P < 0.05) between dACC and several frontal cortical regions, including left superior frontal gyrus (LSFG), and right middle frontal gyrus (RMFG).","[{'ForeName': 'Osama A', 'Initials': 'OA', 'LastName': 'Abulseoud', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA. osama.abulseoud@nih.gov.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Ross', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'Hyung Wook', 'Initials': 'HW', 'LastName': 'Nam', 'Affiliation': 'Department of Pharmacology, Toxicology and Neuroscience, LSU Health Sciences Center, Shreveport, LA, USA.'}, {'ForeName': 'Elisabeth C', 'Initials': 'EC', 'LastName': 'Caparelli', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tennekoon', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Schleyer', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Castillo', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Fedota', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Gu', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'Yihong', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Stein', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0741-9']
2992,31646393,Comparison of fractional neodymium-doped yttrium aluminum garnet (Nd:YAG) 1064-nm picosecond laser and fractional 1550-nm erbium fiber laser in facial acne scar treatment.,"To compare the safety and efficacy of fractional neodymium-doped yttrium aluminum garnet (Nd:YAG) 1064-nm picosecond laser and fractional 1550-nm erbium fiber laser in acne scar treatment and to assess the adverse effects and complications of the two devices. Thirty patients with cosmetically similar acne scars on both sides of the faces were enrolled and treated four times at 4-week intervals. Each side of the face was treated with either fractional 1064-nm Nd:YAG picosecond laser or fractional 1550-nm erbium fiber laser. Efficacy was evaluated using digital photography taken at baseline and 5 months by a blinded dermatologist using the ECCA grading scale (échelle d'évaluation clinique des cicatrices d'acné). Patient overall satisfaction and self-rated improvement scores were recorded at baseline and 5 months. Adverse effects were recorded at every visit. Twenty-seven patients completed the study. Both devices demonstrated significant median ECCA score improvement from baseline (P < 0.001). However, there was no significant difference between the two in terms of median ECCA score improvement, patients' perception of scar improvement, and overall satisfaction. Considering the adverse effects, more pinpoint bleeding was significantly observed with the picosecond laser (P = 0.002), whereas more pain was noted with the erbium laser (P < 0.001). Both fractional 1064-nm Nd:YAG picosecond laser and fractional 1550-nm erbium fiber laser are safe and effective in the treatment of acne scars. Costs should be taken into consideration when deciding on which device to use to maximize treatment outcomes.",2020,"Considering the adverse effects, more pinpoint bleeding was significantly observed with the picosecond laser (P = 0.002), whereas more pain was noted with the erbium laser (P < 0.001).","['Twenty-seven patients completed the study', 'Nd', 'facial acne scar treatment', 'Thirty patients with cosmetically similar acne scars']","['fractional 1064-nm', 'Nd:YAG picosecond laser or fractional 1550-nm erbium fiber laser', 'fractional neodymium-doped yttrium aluminum garnet (Nd:YAG) 1064-nm picosecond laser and fractional 1550-nm erbium fiber laser', 'YAG picosecond laser and fractional 1550-nm erbium fiber laser']","[""median ECCA score improvement, patients' perception of scar improvement, and overall satisfaction"", 'pinpoint bleeding', 'Patient overall satisfaction and self-rated improvement scores', 'safety and efficacy', 'Efficacy', 'Adverse effects', 'median ECCA score improvement', 'pain']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027599', 'cui_str': 'Neodymium'}, {'cui': 'C0013039', 'cui_str': 'Doping in Sports'}, {'cui': 'C1609285', 'cui_str': 'yttrium-aluminum-garnet'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0423783', 'cui_str': 'Acne scar'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0027599', 'cui_str': 'Neodymium'}, {'cui': 'C0013039', 'cui_str': 'Doping in Sports'}, {'cui': 'C1609285', 'cui_str': 'yttrium-aluminum-garnet'}, {'cui': 'C1532556', 'cui_str': 'Picosecond pulsed laser device'}, {'cui': 'C0014688', 'cui_str': 'Erbium'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",30.0,0.0266047,"Considering the adverse effects, more pinpoint bleeding was significantly observed with the picosecond laser (P = 0.002), whereas more pain was noted with the erbium laser (P < 0.001).","[{'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Chayavichitsilp', 'Affiliation': 'Division of Dermatology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, 270 Rama VI Road Ratchathewi, Bangkok, 10400, Thailand. pamela.chaya@gmail.com.'}, {'ForeName': 'Preeyachat', 'Initials': 'P', 'LastName': 'Limtong', 'Affiliation': 'Division of Dermatology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, 270 Rama VI Road Ratchathewi, Bangkok, 10400, Thailand.'}, {'ForeName': 'Korn', 'Initials': 'K', 'LastName': 'Triyangkulsri', 'Affiliation': 'Division of Dermatology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, 270 Rama VI Road Ratchathewi, Bangkok, 10400, Thailand.'}, {'ForeName': 'Nathathai', 'Initials': 'N', 'LastName': 'Pratumchart', 'Affiliation': 'Division of Dermatology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, 270 Rama VI Road Ratchathewi, Bangkok, 10400, Thailand.'}]",Lasers in medical science,['10.1007/s10103-019-02891-5']
2993,32560069,Effects of a Physical Education Intervention on Academic Performance: A Cluster Randomised Controlled Trial.,"BACKGROUND


We investigated the effects of three different interventions on academic performance in students enrolled in the first year of high school.
METHODS


This was a cluster randomised controlled trial conducted with 1200 students enrolled in the first year of high school. Schools were randomly assigned to: 1. Doubling physical education (PE) classes (3:20 h of PE/week); 2. workshop with the PE teachers; 3. workshop with the PE teachers and doubling the PE classes; and 4. control group (1:40 h of PE/week). We assured that the schools within the groups were equal regarding: The structural condition of the sports court; number of PE teachers; number of school classes; and the average number of students per classroom.
RESULTS


Overall, the intervention was not effective in improving the students' academic performance. However, the subgroup analysis showed that the workshop intervention group increased the academic performance of students who had failed an academic year (from 16 years of age), compared to their peers in the doubling the PE classes (1.3 points on average) and the control groups (1.4 points on average).
CONCLUSIONS


Enhancing the pedagogical skills of the teachers is a promising approach in improving the academic performance of students who failed an academic year.",2020,"However, the subgroup analysis showed that the workshop intervention group increased the academic performance of students who had failed an academic year (from 16 years of age), compared to their peers in the doubling the PE classes (1.3 points on average) and the control groups (1.4 points on average).
","['1200 students enrolled in the first year of high school', 'students enrolled in the first year of high school', 'schools within the groups were equal regarding: The structural condition of the sports court; number of PE teachers; number of school classes; and the average number of students per classroom', 'students who failed an academic year']","['workshop intervention', 'Physical Education Intervention']","[""students' academic performance"", 'academic performance', 'Doubling physical education (PE) classes', 'Academic Performance']","[{'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0456387', 'cui_str': 'Class'}]",1200.0,0.0519151,"However, the subgroup analysis showed that the workshop intervention group increased the academic performance of students who had failed an academic year (from 16 years of age), compared to their peers in the doubling the PE classes (1.3 points on average) and the control groups (1.4 points on average).
","[{'ForeName': 'Rodrigo Antunes', 'Initials': 'RA', 'LastName': 'Lima', 'Affiliation': 'Institute of Sport Science, University of Graz, Mozartgasse 14, 8010 Graz, Austria.'}, {'ForeName': 'Fernanda Cunha', 'Initials': 'FC', 'LastName': 'Soares', 'Affiliation': 'Research Group on Lifestyles and Health, University of Pernambuco, Arnóbio Marquês Street, 310, Recife 50100-130, PE, Brazil.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Bezerra', 'Affiliation': 'Research Group on Lifestyles and Health, University of Pernambuco, Arnóbio Marquês Street, 310, Recife 50100-130, PE, Brazil.'}, {'ForeName': 'Mauro Virgílio Gomes', 'Initials': 'MVG', 'LastName': 'de Barros', 'Affiliation': 'Research Group on Lifestyles and Health, University of Pernambuco, Arnóbio Marquês Street, 310, Recife 50100-130, PE, Brazil.'}]",International journal of environmental research and public health,['10.3390/ijerph17124287']
2994,32560099,Temperament and Character Profile and Its Clinical Correlates in Male Patients with Dual Schizophrenia.,"Personality traits are relevant in understanding substance use disorders (SUD) and schizophrenia (SZ), but few works have also included patients with dual schizophrenia (SZ+) and personality traits. We explored personality profile in a sample of 165 male patients under treatment, using the Temperament and Character Inventory-Revised. The participants were assigned to three groups of 55 patients each, according to previous diagnosis: SUD, SZ- and SZ+ (without/with SUD). We analyzed their clinical characteristics, relating them to personality dimensions. The SUD and SZ+ groups scored higher than SZ- in Novelty/Sensation Seeking. SZ- and SZ+ presented higher Harm Avoidance and lower Persistence than the SUD group. SZ+ patients showed the lowest levels of Self-directedness, while SZ- and SZ+ had higher scores in Self-transcendence than the SUD group. Several clinical characteristics were associated with personality dimensions depending on diagnosis, and remarkably so for psychiatric symptoms in the SZ- and SZ+ groups. The three groups had a maladaptive personality profile compared to general population. Our results point to different profiles for SUD versus SZ, while both profiles appear combined in the SZ+ group, with extreme scores in some traits. Thus, considering personality endophenotypes in SZ+ could help in designing individualized interventions for this group.",2020,"SZ+ patients showed the lowest levels of Self-directedness, while SZ- and SZ+ had higher scores in Self-transcendence than the SUD group.","['patients with dual schizophrenia (SZ+) and personality traits', 'Male Patients with Dual Schizophrenia', '165 male patients under treatment, using the Temperament and Character Inventory-Revised', '55 patients each, according to previous diagnosis']","['SUD, SZ- and SZ', 'SZ', 'SZ- and SZ']","['maladaptive personality profile', 'lowest levels of Self-directedness', 'Self-transcendence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0233849', 'cui_str': 'Character trait finding'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0039474', 'cui_str': 'Temperament'}, {'cui': 'C0007952', 'cui_str': 'Character'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0332132', 'cui_str': 'Prior diagnosis'}]","[{'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0003944', 'cui_str': 'As If Personality'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",165.0,0.0165927,"SZ+ patients showed the lowest levels of Self-directedness, while SZ- and SZ+ had higher scores in Self-transcendence than the SUD group.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Río-Martínez', 'Affiliation': ""Department of Clinical Psychology and Psychobiology, School of Psychology, University of Barcelona, Passeig de la Vall d'Hebrón 171, 08035 Barcelona, Spain.""}, {'ForeName': 'Julia E', 'Initials': 'JE', 'LastName': 'Marquez-Arrico', 'Affiliation': ""Department of Clinical Psychology and Psychobiology, School of Psychology, University of Barcelona, Passeig de la Vall d'Hebrón 171, 08035 Barcelona, Spain.""}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Prat', 'Affiliation': ""Department of Clinical Psychology and Psychobiology, School of Psychology, University of Barcelona, Passeig de la Vall d'Hebrón 171, 08035 Barcelona, Spain.""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Adan', 'Affiliation': ""Department of Clinical Psychology and Psychobiology, School of Psychology, University of Barcelona, Passeig de la Vall d'Hebrón 171, 08035 Barcelona, Spain.""}]",Journal of clinical medicine,['10.3390/jcm9061876']
2995,32560125,"The Effect of Loving-Kindness Meditation on Flight Attendants' Spirituality, Mindfulness and Subjective Well-Being.","Background : This study investigated: (1) the effects of the loving-kindness meditation (LKM) on mindfulness, subjective well-being (SWB), and spirituality and (2) the relationships between mindfulness, spirituality, and SWB.  Methods : 98 flight attendants from Xiamen Airlines in China were recruited and randomly assigned to the LKM training group ( n  = 49) or the waiting control group ( n  = 49). The LKM training group underwent an 8-week LKM training intervention, and the control group did not undergo intervention. The three main variables (SWB, mindfulness, and spirituality) were measured both before (pre-test) and after (post-test) the LKM training intervention.  Results : In the experimental group, SWB and spirituality increased significantly. In the control group, no significant differences were observed for the three variables between the pre-test and post-test.  Conclusions : Our results indicated that LKM may help to improve SWB and spirituality. However, the mechanisms which underlie the effects of the LKM on mindfulness, spirituality, SWB, and other psychological constructs require further elucidation.",2020,"In the control group, no significant differences were observed for the three variables between the pre-test and post-test.  ",['Methods : 98 flight attendants from Xiamen Airlines in China'],"[' ', 'waiting control group', 'LKM', 'loving-kindness meditation (LKM', 'LKM training intervention, and the control group did not undergo intervention', 'LKM training', 'Loving-Kindness Meditation']","['mindfulness, subjective well-being (SWB), and spirituality and (2) the relationships between mindfulness, spirituality, and SWB', 'SWB and spirituality', 'variables (SWB, mindfulness, and spirituality']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024028', 'cui_str': 'Love'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0237104', 'cui_str': 'Spirituality'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",,0.0166254,"In the control group, no significant differences were observed for the three variables between the pre-test and post-test.  ","[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'College of Aviation, Hua Qiao University, Xiamen 361021, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Graduate Institute of Business and Management, Chang Gung University, Taoyuan 33302, Taiwan.'}, {'ForeName': 'Chia-Yi', 'Initials': 'CY', 'LastName': 'Liu', 'Affiliation': 'Department of Psychiatry, Chang Gung Memorial Hospital, Taipei 10507, Taiwan.'}, {'ForeName': 'Rung-Tai', 'Initials': 'RT', 'LastName': 'Lin', 'Affiliation': 'Graduate School of Creative Industry Design, National Taiwan University of Arts, New Taipei 22058, Taiwan.'}, {'ForeName': 'Wen-Ko', 'Initials': 'WK', 'LastName': 'Chiou', 'Affiliation': 'Department of Psychiatry, Chang Gung Memorial Hospital, Taipei 10507, Taiwan.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare8020174']
2996,32560472,Repeated Menthol Mouth Swilling Affects Neither Strength nor Power Performance.,"This study aimed to assess the effects of repeated menthol mouth swilling upon strength and power performance. Nineteen (10 male) participants completed familiarisation and experimental trials of repeated menthol mouth swilling (0.1% concentration) or control (no swill) in a randomised crossover design. Participants performed an isometric mid-thigh pull (IMTP; peak and mean force; N), vertical jump (peak; cm) and six second sprint (peak and mean power; W) under each condition. Participants completed three efforts per exercise task interspersed with three-minute recoveries. Mean best values were analysed via a two-way mixed repeated measures ANOVA, and differences reported as effect sizes ± 95% confidence intervals, with accompanying descriptors and  p  values. Differences in peak IMTP values were unclear between familiarisation and experimental trials, and between menthol and control conditions. Mean IMTP force differed between familiarisation and control (0.51; -0.15 to 1.14;  p  = 0.001) and familiarisation and menthol conditions (0.50; -0.15 to 1.14;  p  = 0.002) by a small degree, but were unclear between control and menthol conditions. Unclear differences were also noted on vertical jump performance compared to familiarisation and between experimental conditions, with repeated six second peak and average power performance also showing unclear effects across all comparisons. We conclude that repeated menthol mouth swilling does not improve strength or power performance.",2020,"Mean IMTP force differed between familiarisation and control (0.51; -0.15 to 1.14;  p  = 0.001) and familiarisation and menthol conditions (0.50; -0.15 to 1.14;  p  = 0.002) by a small degree, but were unclear between control and menthol conditions.",['Nineteen (10 male) participants completed familiarisation and experimental trials of repeated'],['menthol mouth swilling (0.1% concentration) or control (no swill'],"['peak IMTP values', 'strength or power performance', 'vertical jump performance', 'strength and power performance', 'Strength nor Power Performance', 'Mean IMTP force']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}]","[{'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0443221', 'cui_str': 'Forced'}]",,0.128886,"Mean IMTP force differed between familiarisation and control (0.51; -0.15 to 1.14;  p  = 0.001) and familiarisation and menthol conditions (0.50; -0.15 to 1.14;  p  = 0.002) by a small degree, but were unclear between control and menthol conditions.","[{'ForeName': 'Russ', 'Initials': 'R', 'LastName': 'Best', 'Affiliation': 'Centre for Sport Science and Human Performance, Wintec, Hamilton 3200, New Zealand.'}, {'ForeName': 'Dani', 'Initials': 'D', 'LastName': 'Temm', 'Affiliation': 'Centre for Sport Science and Human Performance, Wintec, Hamilton 3200, New Zealand.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Hucker', 'Affiliation': 'Centre for Sport Science and Human Performance, Wintec, Hamilton 3200, New Zealand.'}, {'ForeName': 'Kerin', 'Initials': 'K', 'LastName': 'McDonald', 'Affiliation': 'Centre for Sport Science and Human Performance, Wintec, Hamilton 3200, New Zealand.'}]","Sports (Basel, Switzerland)",['10.3390/sports8060090']
2997,32560485,Real-World Setting Cost-Effectiveness Analysis Comparing Three Therapeutic Schemes of One-Year Adjuvant Trastuzumab in HER2-Positive Early Breast Cancer from the Cyprus NHS Payer Perspective.,"INTRODUCTION


This study is one of the first real-world cost-effectiveness analyses of one-year adjuvant trastuzumab used in HER2-positive early female breast cancer in comparison to chemotherapy alone. It is just the second one in Europe, the first one in Cyprus, and the fourth one worldwide ever carried out using real-world data.
METHODS


Using a Markov model (four health states), a cost-effectiveness analysis was carried out both over 20 years and for a lifetime horizon. The sampling method used in this study was the randomized sampling of 900 women.
RESULTS


The findings for the 20-year horizon showed that all trastuzumab arms were more cost-effective, with a willingness-to-pay threshold of only €60,000 per quality-adjusted life year (QALY) [incremental cost-effectiveness ratios (ICER): €40,436.10/QALY]. For the lifetime horizon, with thresholds of €20,000, €40,000, and €60,000/QALY, all trastuzumab arms were found to be more cost-effective (ICER: €17,753.85/QALY). Moreover, for the 20-year and the lifetime horizons, with thresholds of €20,000/QALY, €40,000/QALY, and €60,000/QALY, the most cost-effective of the three subgroups (anthracyclines and then trastuzumab, no anthracyclines and then trastuzumab, and anthracyclines, taxanes, and trastuzumab) was that of anthracyclines and then trastuzumab (ICER: €18,301.55/QALY and €8954.97/QALY, respectively).
CONCLUSIONS


The study revealed that adjuvant trastuzumab for one year in female HER2-positive early breast cancer can be considered cost-effective.",2020,"The findings for the 20-year horizon showed that all trastuzumab arms were more cost-effective, with a willingness-to-pay threshold of only €60,000 per quality-adjusted life year (QALY) [incremental cost-effectiveness ratios (ICER): €40,436.10/QALY].","['HER2-positive early female breast cancer in comparison to chemotherapy alone', 'female HER2-positive early breast cancer', '900 women']","['Trastuzumab', 'adjuvant trastuzumab']","['quality-adjusted life year (QALY) [incremental cost-effectiveness ratios (ICER): €40,436.10/QALY', 'cost-effective']","[{'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0235653', 'cui_str': 'Malignant neoplasm of female breast'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C4517900', 'cui_str': '900'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0166592,"The findings for the 20-year horizon showed that all trastuzumab arms were more cost-effective, with a willingness-to-pay threshold of only €60,000 per quality-adjusted life year (QALY) [incremental cost-effectiveness ratios (ICER): €40,436.10/QALY].","[{'ForeName': 'Savvas S', 'Initials': 'SS', 'LastName': 'Ioannou', 'Affiliation': 'Healthcare Management Postgraduate Program, Open University Cyprus, P.O. Box 12794, Nicosia 2255, Cyprus.'}, {'ForeName': 'Yiola', 'Initials': 'Y', 'LastName': 'Marcou', 'Affiliation': 'Department of Medical Oncology, Bank of Cyprus Oncology Center, 32 Acropoleos Avenue, 2006 Strovolos, Nicosia 2255, Cyprus.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Kakouri', 'Affiliation': 'Department of Medical Oncology, Bank of Cyprus Oncology Center, 32 Acropoleos Avenue, 2006 Strovolos, Nicosia 2255, Cyprus.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Talias', 'Affiliation': 'Healthcare Management Postgraduate Program, Open University Cyprus, P.O. Box 12794, Nicosia 2255, Cyprus.'}]",International journal of environmental research and public health,['10.3390/ijerph17124339']
2998,32560516,"Body Fat Changes and Liver Safety in Obese and Overweight Women Supplemented with Conjugated Linoleic Acid: A 12-Week Randomised, Double-Blind, Placebo-Controlled Trial.","Preliminary evidence suggests that conjugated linoleic acid (CLA) may reduce body weight and affect body composition. The present study assessed the effect of CLA supplementation on body fat composition in overweight and obese women, while also evaluating the liver safety of CLA use. Seventy-four obese or overweight women were randomly assigned to receive 3 g/day CLA or placebo for 12 weeks. Body composition (dual-energy X-ray absorptiometry) and liver function ( 13 C-methacetin breath test and serum liver enzymes) were assessed before and after the trial. Patients receiving CLA experienced a significant reduction of total body fat expressed as mass ( p  = 0.0007) and percentage ( p  = 0.0006), android adipose tissue ( p  = 0.0002), gynoid adipose tissue ( p  = 0.0028), and visceral adipose tissue ( p  = 4.2 × 10 -9 ) as well as a significant increase in lean body mass to height ( p  = 6.1 × 10 -11 ) when compared to those receiving a placebo. The maximum momentary 13C recovery changes and end-point values were significantly higher in the CLA group when compared to the placebo group ( p  = 0.0385 and  p  = 0.0076, respectively). There were no significant changes in alanine aminotransferase, asparagine aminotransferase, and gamma-glutamyl transpeptidase activities between the groups. In conclusion, CLA supplementation was well tolerated and safe for the liver, which shows beneficial effects on fat composition in overweight and obese women.",2020,"Patients receiving CLA experienced a significant reduction of total body fat expressed as mass ( p  = 0.0007) and percentage ( p  = 0.0006), android adipose tissue ( p  = 0.0002), gynoid adipose tissue ( p  = 0.0028), and visceral adipose tissue ( p  = 4.2 × 10 -9 ) as well as a significant increase in lean body mass to height ( p  ","['Seventy-four obese or overweight women', 'overweight and obese women', 'Obese and Overweight Women Supplemented with']","['CLA supplementation', 'Placebo', 'conjugated linoleic acid (CLA', 'placebo', 'CLA or placebo', 'Conjugated Linoleic Acid', 'CLA']","['maximum momentary 13C recovery changes and end-point values', 'Body Fat Changes and Liver Safety', 'visceral adipose tissue', 'alanine aminotransferase, asparagine aminotransferase, and gamma-glutamyl transpeptidase activities', 'body fat composition', 'total body fat', 'tolerated and safe', 'Body composition (dual-energy X-ray absorptiometry) and liver function ( 13 C-methacetin breath test and serum liver enzymes', 'gynoid adipose tissue', 'android adipose tissue', 'lean body mass to height', 'body weight and affect body composition']","[{'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0050156', 'cui_str': '9,11-linoleic acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0074380', 'cui_str': 'Serine-glyoxylate aminotransferase'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0424677', 'cui_str': 'Total body fat'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0729631', 'cui_str': 'Carbon-13'}, {'cui': 'C0066070', 'cui_str': 'methacetin'}, {'cui': 'C0006153', 'cui_str': 'Breath test'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0336541', 'cui_str': 'Android'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",74.0,0.162104,"Patients receiving CLA experienced a significant reduction of total body fat expressed as mass ( p  = 0.0007) and percentage ( p  = 0.0006), android adipose tissue ( p  = 0.0002), gynoid adipose tissue ( p  = 0.0028), and visceral adipose tissue ( p  = 4.2 × 10 -9 ) as well as a significant increase in lean body mass to height ( p  ","[{'ForeName': 'Edyta', 'Initials': 'E', 'LastName': 'Mądry', 'Affiliation': 'Department of Physiology, Poznan University of Medical Sciences, 61701 Poznań, Poland.'}, {'ForeName': 'Ida Judyta', 'Initials': 'IJ', 'LastName': 'Malesza', 'Affiliation': 'Department of Pediatric Gastroenterology and Metabolic Diseases, Poznan University of Medical Sciences, 61701 Poznań, Poland.'}, {'ForeName': 'Mehala', 'Initials': 'M', 'LastName': 'Subramaniapillai', 'Affiliation': 'Department of Physiology, Poznan University of Medical Sciences, 61701 Poznań, Poland.'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Czochralska-Duszyńska', 'Affiliation': 'Department of Physiology, Poznan University of Medical Sciences, 61701 Poznań, Poland.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Walkowiak', 'Affiliation': 'Division of Reproduction, Department of Gynecology and Obstetrics, Poznan University of Medical Sciences, 61701 Poznań, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Miśkiewicz-Chotnicka', 'Affiliation': 'Department of Pediatric Gastroenterology and Metabolic Diseases, Poznan University of Medical Sciences, 61701 Poznań, Poland.'}, {'ForeName': 'Jarosław', 'Initials': 'J', 'LastName': 'Walkowiak', 'Affiliation': 'Department of Pediatric Gastroenterology and Metabolic Diseases, Poznan University of Medical Sciences, 61701 Poznań, Poland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Lisowska', 'Affiliation': 'Department of Clinical Auxology and Pediatric Nursing, Poznan University of Medical Sciences, 61701 Poznań, Poland.'}]",Nutrients,['10.3390/nu12061811']
2999,32560526,The Application of Structural Retinal Biomarkers to Evaluate the Effect of Intravitreal Ranibizumab and Dexamethasone Intravitreal Implant on Treatment of Diabetic Macular Edema.,"BACKGROUND


The aim of this study was to compare the therapeutic effect of intravitreal treatment with ranibizumab and dexamethasone using specific swept-source optical coherence tomography retinal biomarkers in patients with diabetic macular edema (DME).
METHODS


156 treatment-naïve patients with DME were divided in two groups: 75 patients received 3 monthly intravitreal injections of ranibizumab 0.5 mg (Lucentis ® ) (Group 1) and 81 patients received an intravitreal implant of dexamethasone 0.7 mg (Ozurdex ® ) (Group 2). Patients were evaluated at baseline (V1), at three months post-treatment in Group 1, and at two months post-treatment in Group 2 (V2). Best-corrected visual acuity (BCVA) and swept source-OCT were recorded at each interval. Changes between V1 and V2 were analyzed using the Wilcoxon test and differences between the two groups of treatment were assessed using the Mann-Whitney test. Multiple regression analysis was performed to evaluate the possible OCT biomarker (CRT, ICR, CT, SND, HRS) as predictive factors for final visual acuity improvement.
RESULTS


In both groups, BCVA improved ( p -value < 0.0001), and a significant reduction in central retinal thickness, intra-retinal cysts, red dots, hyper-reflective spots (HRS), and serous detachment of neuro-epithelium (SDN) was observed. A superiority of dexamethasone over ranibizumab in reducing the SDN height ( p -value = 0.03) and HRS ( p -value = 0.01) was documented.
CONCLUSIONS


Ranibizumab and dexamethasone are effective in the treatment of DME, as demonstrated by functional improvement and morphological biomarker change. DME associated with SDN and HRS represents a specific inflammatory pattern for which dexamethasone appears to be more effective.",2020,"In both groups, BCVA improved ( p -value < 0.0001), and a significant reduction in central retinal thickness, intra-retinal cysts, red dots, hyper-reflective spots (HRS), and serous detachment of neuro-epithelium (SDN) was observed.","['156 treatment-naïve patients with DME', 'Diabetic Macular Edema', 'patients with diabetic macular edema (DME']","['DME', 'dexamethasone', 'ranibizumab 0.5 mg (Lucentis ® ', 'ranibizumab and dexamethasone using specific swept-source optical coherence tomography retinal biomarkers', 'Intravitreal Ranibizumab and Dexamethasone Intravitreal Implant', 'Ranibizumab and dexamethasone', 'ranibizumab', 'intravitreal implant of dexamethasone 0.7 mg (Ozurdex ® ']","['central retinal thickness, intra-retinal cysts, red dots, hyper-reflective spots (HRS), and serous detachment of neuro-epithelium (SDN', 'possible OCT biomarker (CRT, ICR, CT, SND, HRS', 'SDN height', 'BCVA', 'Best-corrected visual acuity (BCVA) and swept source-OCT']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}]","[{'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C1721374', 'cui_str': 'Lucentis'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C2702454', 'cui_str': 'Dexamethasone Drug Implant'}, {'cui': 'C1299681', 'cui_str': 'Intravitreal implant'}, {'cui': 'C2702453', 'cui_str': 'Dexamethasone 0.7 MG'}, {'cui': 'C2702456', 'cui_str': 'Ozurdex'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0520724', 'cui_str': 'Retinal cyst'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial dots'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0440743', 'cui_str': 'Serous'}, {'cui': 'C0541879', 'cui_str': 'Detachment psychological'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0014609', 'cui_str': 'Epithelium'}, {'cui': 'C0038642', 'cui_str': 'Sudan'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}, {'cui': 'C0025925', 'cui_str': 'Mouse, Inbred ICR'}, {'cui': 'C0574347', 'cui_str': 'Sindhi language'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0449416', 'cui_str': 'Source'}]",156.0,0.03862,"In both groups, BCVA improved ( p -value < 0.0001), and a significant reduction in central retinal thickness, intra-retinal cysts, red dots, hyper-reflective spots (HRS), and serous detachment of neuro-epithelium (SDN) was observed.","[{'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Ceravolo', 'Affiliation': 'Institute of Ophthalmology, Department of Biomedical Sciences, University of Messina, 98124 Messina, Italy.'}, {'ForeName': 'Giovanni William', 'Initials': 'GW', 'LastName': 'Oliverio', 'Affiliation': 'Institute of Ophthalmology, Department of Biomedical Sciences, University of Messina, 98124 Messina, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Alibrandi', 'Affiliation': 'Institute of Ophthalmology, Department of Biomedical Sciences, University of Messina, 98124 Messina, Italy.'}, {'ForeName': 'Ahsan', 'Initials': 'A', 'LastName': 'Bhatti', 'Affiliation': 'Glangwili General Hospital Carmarthen, Wales SA31 2AF, UK.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Trombetta', 'Affiliation': 'Institute of Ophthalmology, Department of Biomedical Sciences, University of Messina, 98124 Messina, Italy.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Rejdak', 'Affiliation': 'Department of General Ophthalmology and Pediatric Ophthalmology Service, Medical University of Lublin, 20079 Lublin, Poland.'}, {'ForeName': 'Mario Damiano', 'Initials': 'MD', 'LastName': 'Toro', 'Affiliation': 'Department of General Ophthalmology and Pediatric Ophthalmology Service, Medical University of Lublin, 20079 Lublin, Poland.'}, {'ForeName': 'Costantino John', 'Initials': 'CJ', 'LastName': 'Trombetta', 'Affiliation': 'Institute of Ophthalmology, Department of Biomedical Sciences, University of Messina, 98124 Messina, Italy.'}]","Diagnostics (Basel, Switzerland)",['10.3390/diagnostics10060413']
3000,32560689,The Patient Activation through Community Empowerment/Engagement for Diabetes Management (PACE-D) protocol: a non-randomised controlled trial of personalised care and support planning for persons living with diabetes.,"BACKGROUND


Personalised care and support planning (CSP) has been shown to improve diabetes outcomes, patient experience and provider morale in the care of persons living with diabetes. However, this has not been confirmed in controlled studies. Patient Activation through Community Empowerment/Engagement for Diabetes Management (PACE-D) is a pragmatic controlled trial that evaluates the effectiveness of personalised CSP in persons living with diabetes in the public primary care setting in Singapore.
METHODS


Teamlet-empanelled patients with diabetes at four polyclinics are recruited for this study. Participants who attend either of the two Intervention clinics are sent their investigation results in a care planning letter (CPL) to prepare them for the CSP conversation. This conversation is facilitated by a trained CSP practitioner who engages them in discussion of concerns, goals and action plans, and documents their plans for subsequent review. Participants in the two Control clinics will receive standard diabetes care. Participants will complete two or more CSP conversations (Intervention) or regular consultations (Control) at the annual review visits within the 18 months of the study. The sample size is calculated at 1620 participants, with glycated haemoglobin (HbA1c) as the primary outcome measure. Secondary outcome measures include patient activation (as measured by PAM-13) and changes in healthcare utilisation and cost.
DISCUSSION


This study is a pragmatic trial that evaluates the effectiveness of personalised CSP in persons living with diabetes in a real world setting. It promises to provide insights with regard to the implementation of this model of care in Singapore and the region.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier NCT04288362. Retrospectively registered on 28 February 2020.",2020,"Patient Activation through Community Empowerment/Engagement for Diabetes Management (PACE-D) is a pragmatic controlled trial that evaluates the effectiveness of personalised CSP in persons living with diabetes in the public primary care setting in Singapore.
","['Participants who attend either of the two Intervention clinics are sent their investigation results in a care planning letter (CPL) to prepare them for the CSP conversation', 'persons living with diabetes in a real world setting', 'persons living with diabetes', 'persons living with diabetes in the public primary care setting in Singapore', 'Participants will complete two or more CSP conversations (Intervention) or regular consultations (Control) at the annual review visits within the 18\u2009months of the study', 'Retrospectively registered on 28 February 2020', 'Teamlet-empanelled patients with diabetes at four polyclinics are recruited for this study']","['personalised care and support planning', 'personalised CSP', 'standard diabetes care', 'Personalised care and support planning (CSP']",['patient activation (as measured by PAM-13) and changes in healthcare utilisation and cost'],"[{'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0178916', 'cui_str': 'Care plan'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2931826', 'cui_str': 'Potassium aggravated myotonia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.0727258,"Patient Activation through Community Empowerment/Engagement for Diabetes Management (PACE-D) is a pragmatic controlled trial that evaluates the effectiveness of personalised CSP in persons living with diabetes in the public primary care setting in Singapore.
","[{'ForeName': 'Wee Hian', 'Initials': 'WH', 'LastName': 'Tan', 'Affiliation': 'National University Polyclinics, National University Health System, Singapore, Singapore. wee_hian_tan@nuhs.edu.sg.'}, {'ForeName': 'Victor Weng Keong', 'Initials': 'VWK', 'LastName': 'Loh', 'Affiliation': 'Division of Family Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Venkataraman', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Shoon Thai', 'Initials': 'ST', 'LastName': 'Choong', 'Affiliation': 'National University Polyclinics, National University Health System, Singapore, Singapore.'}, {'ForeName': 'Yii Jen', 'Initials': 'YJ', 'LastName': 'Lew', 'Affiliation': 'National University Polyclinics, National University Health System, Singapore, Singapore.'}, {'ForeName': 'Meena', 'Initials': 'M', 'LastName': 'Sundram', 'Affiliation': 'National University Polyclinics, National University Health System, Singapore, Singapore.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Tsou', 'Affiliation': 'National University Polyclinics, National University Health System, Singapore, Singapore.'}, {'ForeName': 'Soon Guan', 'Initials': 'SG', 'LastName': 'Tan', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Gibbons', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Vikki', 'Initials': 'V', 'LastName': 'Entwistle', 'Affiliation': 'Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Young', 'Affiliation': 'Division of Family Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'E Shyong', 'Initials': 'ES', 'LastName': 'Tai', 'Affiliation': 'Division of Endocrinology, University Medicine Cluster, National University Health System, Singapore, Singapore.'}, {'ForeName': 'Tong Wei', 'Initials': 'TW', 'LastName': 'Yew', 'Affiliation': 'Division of Endocrinology, University Medicine Cluster, National University Health System, Singapore, Singapore.'}]",BMC family practice,['10.1186/s12875-020-01173-2']
3001,32560705,The psychometric properties of PHQ-4 anxiety and depression screening scale among out of school adolescent girls and young women in Tanzania: a cross-sectional study.,"BACKGROUND


Literature suggests that most mental disorders have their onset in childhood and adolescence, but go undiagnosed until adulthood. Shorter versions of the screening tools such as the Patient Health Questionnaire with four items (PHQ-4) may help to improve screening coverage. This study assessed the psychometric properties of the PHQ-4 in screening for core symptoms of depression and anxiety among out of school adolescent girls and young women (AGYW).
METHODS


This is a cross-sectional analysis of data from a cluster randomized controlled trial conducted among AGYW between June and July 2018 in North-West Tanzania. Two thousand four hundred twenty-six out-of-school AGYW aged 15 to 23 years were included. Data were collected on tablets using audio computer-assisted self-interviews (ACASI). Cronbach's α was used to measure the reliability of the PHQ-4 while confirmatory factor analysis (CFA) and principal components analysis (PCA) were used for construct validity assessment. In CFA, three criteria were used to assess how well the model fits the data: Standardized Root Mean Square Residual (SRMR), the Comparative Fit Index (CFI), the Root Mean Square Error of Approximation (RMSEA) and 90% confidence interval for RMSEA.
RESULTS


Of the 2426 participants, 33.8 and 35.5% screened positive for core symptoms of anxiety (GAD-2 ≥ 3) and depression (PHQ-2 ≥ 3), respectively. Cronbach's α of the PHQ-4 was 0.81. Both items-correlation and corrected items-correlation of the PHQ-4 had total correlations above 0.5 (p < 0.01). CFA showed that all items loaded significantly onto the single factor, and loadings were strong, ranging from 0.67 to 0.77 (p < 0.01). CFA indicates that the PHQ-4 scale stand for a unidimensional construct with good model fit (CFI = 0.995, SRMR = 0.013, RMSEA = 0.054 and 90% CI for RMSEA (0.031-0.079)). PCA confirmed two distinct components; GAD-2 (anxiety) and PHQ-2 (depression). Those who reported having suicidal thoughts and social function problems had significantly higher scores on PHQ-2, GAD-2, and PHQ-4 screening items (p < 0.01).
CONCLUSIONS


The findings suggest that the PHQ-4 scale can reliably and validly screen for core symptoms of depression and anxiety among out of school AGYW. This tool is short and easy to administer. Thus, the PHQ-4 scale can be very useful in screening for anxiety and depression symptoms in the community, primary health facilities, research and programmatic settings.",2020,"Those who reported having suicidal thoughts and social function problems had significantly higher scores on PHQ-2, GAD-2, and PHQ-4 screening items (p < 0.01).
","['school adolescent girls and young women in Tanzania', 'school adolescent girls and young women (AGYW', 'AGYW between June and July 2018 in North-West Tanzania', 'Two thousand four hundred twenty-six out-of-school AGYW aged 15 to 23\u2009years were included']",['PHQ-4'],"['CFA', 'GAD-2 (anxiety) and PHQ-2 (depression', 'PHQ-4 anxiety and depression screening scale', 'Standardized Root Mean Square Residual (SRMR), the Comparative Fit Index (CFI), the Root Mean Square Error of Approximation (RMSEA', 'PHQ-2, GAD-2, and PHQ-4 screening items']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C4517656', 'cui_str': '2400'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}]","[{'cui': 'C0085801', 'cui_str': 'Factor Analysis'}, {'cui': 'C5197676', 'cui_str': 'GAD-2'}, {'cui': 'C2706101', 'cui_str': 'PHQ-2'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0740218', 'cui_str': 'Depression screening'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]",2426.0,0.0337356,"Those who reported having suicidal thoughts and social function problems had significantly higher scores on PHQ-2, GAD-2, and PHQ-4 screening items (p < 0.01).
","[{'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Materu', 'Affiliation': 'Department of Sexual and Reproductive Health, National Institute for Medical Research, Mwanza Centre, P.O Box 1462, Mwanza, Tanzania. jacqueline.materu1989@gmail.com.'}, {'ForeName': 'Evodius', 'Initials': 'E', 'LastName': 'Kuringe', 'Affiliation': 'Department of Sexual and Reproductive Health, National Institute for Medical Research, Mwanza Centre, P.O Box 1462, Mwanza, Tanzania.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Nyato', 'Affiliation': 'Department of Sexual and Reproductive Health, National Institute for Medical Research, Mwanza Centre, P.O Box 1462, Mwanza, Tanzania.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Galishi', 'Affiliation': 'Sauti Project, Jhpiego Tanzania - an affiliate of Johns Hopkins University, Dar es Salaam, Tanzania.'}, {'ForeName': 'Amasha', 'Initials': 'A', 'LastName': 'Mwanamsangu', 'Affiliation': 'Sauti Project, Jhpiego Tanzania - an affiliate of Johns Hopkins University, Dar es Salaam, Tanzania.'}, {'ForeName': 'Maligo', 'Initials': 'M', 'LastName': 'Katebalila', 'Affiliation': 'Sauti Project, Jhpiego Tanzania - an affiliate of Johns Hopkins University, Dar es Salaam, Tanzania.'}, {'ForeName': 'Amani', 'Initials': 'A', 'LastName': 'Shao', 'Affiliation': 'Department of Sexual and Reproductive Health, National Institute for Medical Research, Mwanza Centre, P.O Box 1462, Mwanza, Tanzania.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Changalucha', 'Affiliation': 'Department of Sexual and Reproductive Health, National Institute for Medical Research, Mwanza Centre, P.O Box 1462, Mwanza, Tanzania.'}, {'ForeName': 'Soori', 'Initials': 'S', 'LastName': 'Nnko', 'Affiliation': 'Department of Sexual and Reproductive Health, National Institute for Medical Research, Mwanza Centre, P.O Box 1462, Mwanza, Tanzania.'}, {'ForeName': 'Mwita', 'Initials': 'M', 'LastName': 'Wambura', 'Affiliation': 'Department of Sexual and Reproductive Health, National Institute for Medical Research, Mwanza Centre, P.O Box 1462, Mwanza, Tanzania.'}]",BMC psychiatry,['10.1186/s12888-020-02735-5']
3002,32560714,On-site multi-component intervention to improve productivity and reduce the economic and personal burden of neck pain in Swiss office-workers (NEXpro): protocol for a cluster-randomized controlled trial.,"BACKGROUND


Non-specific neck pain and headache are major economic and individual burden in office-workers. The aim of this study is to investigate the effect of a multi-component intervention combining workstation ergonomics, health promotion information group workshops, neck exercises, and an app to enhance intervention adherence to assess possible reductions in the economic and individual burden of prevalent and incident neck pain and headache in office workers.
METHODS/DESIGN


This study is a stepped wedge cluster-randomized controlled trial. Eligible participants will be any office-worker aged 18-65 years from two Swiss organisations in the Cantons of Zurich and Aargau, working more than 25 h a week in predominantly sedentary office work and without serious health conditions of the neck. One hundred twenty voluntary participants will be assigned to 15 clusters which, at randomly selected time steps, switch from the control to the intervention group. The intervention will last 12 weeks and comprises workstation ergonomics, health promotion information group workshops, neck exercises and an adherence app. The primary outcome will be health-related productivity losses (presenteeism, absenteeism) using the Work Productivity and Activity Impairment Questionnaire. Secondary outcomes are neck disability and pain (measured by the Neck Disability Index, and muscle strength and endurance measures), headache (measured by the short-form headache impact test), psychosocial outcomes (e.g. job-stress index, Fear-Avoidance Beliefs Questionnaire), workplace outcomes (e.g. workstation ergonomics), adherence to intervention, and additional measures (e.g. care-seeking). Measurements will take place at baseline, 4 months, 8 months, and 12 months after commencement. Data will be analysed on an intention to treat basis and per protocol. Primary and secondary outcomes will be examined using linear mixed-effects models.
DISCUSSION


To the authors' knowledge, this study is the first that investigates the impact of a multi-component intervention combining current evidence of effective interventions with an adherence app to assess the potential benefits on productivity, prevalent and incident neck pain, and headache. The outcomes will impact the individual, their workplace, as well as private and public policy by offering evidence for treatment and prevention of neck pain and headache in office-workers.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT04169646. Registered 15 November 2019 - Retrospectively registered.",2020,"The primary outcome will be health-related productivity losses (presenteeism, absenteeism) using the Work Productivity and Activity Impairment Questionnaire.","['One hundred twenty voluntary participants', 'Registered 15 November 2019 - Retrospectively registered', 'Swiss office-workers (NEXpro', 'Eligible participants will be any office-worker aged 18-65\u2009years from two Swiss organisations in the Cantons of Zurich and Aargau, working more than 25\u2009h a week in predominantly sedentary office work and without serious health conditions of the neck']","['workstation ergonomics, health promotion information group workshops, neck exercises and an adherence app']","['neck disability and pain (measured by the Neck Disability Index, and muscle strength and endurance measures), headache (measured by the short-form headache impact test), psychosocial outcomes (e.g. job-stress index, Fear-Avoidance Beliefs Questionnaire), workplace outcomes (e.g. workstation ergonomics), adherence to intervention, and additional measures (e.g. care-seeking', 'health-related productivity losses (presenteeism, absenteeism) using the Work Productivity and Activity Impairment Questionnaire', 'productivity, prevalent and incident neck pain, and headache']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}]","[{'cui': 'C1736830', 'cui_str': 'Workstation'}, {'cui': 'C0086246', 'cui_str': 'Human Engineering'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0454347', 'cui_str': 'Neck exercises'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C1736830', 'cui_str': 'Workstation'}, {'cui': 'C0086246', 'cui_str': 'Human Engineering'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C4042785', 'cui_str': 'Sickness Presence'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}]",120.0,0.182642,"The primary outcome will be health-related productivity losses (presenteeism, absenteeism) using the Work Productivity and Activity Impairment Questionnaire.","[{'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Aegerter', 'Affiliation': 'ZHAW School of Health Professions, Technikumstrasse 71, 8400, Winterthur, Switzerland. andrea.aegerter@zhaw.ch.'}, {'ForeName': 'Manja', 'Initials': 'M', 'LastName': 'Deforth', 'Affiliation': 'ZHAW School of Health Professions, Technikumstrasse 71, 8400, Winterthur, Switzerland.'}, {'ForeName': 'Venerina', 'Initials': 'V', 'LastName': 'Johnston', 'Affiliation': 'The University of Queensland, School of Health and Rehabilitation Sciences, Brisbane, Queensland, Australia.'}, {'ForeName': 'Markus J', 'Initials': 'MJ', 'LastName': 'Ernst', 'Affiliation': 'ZHAW School of Health Professions, Technikumstrasse 71, 8400, Winterthur, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Volken', 'Affiliation': 'ZHAW School of Health Professions, Technikumstrasse 71, 8400, Winterthur, Switzerland.'}, {'ForeName': 'Hannu', 'Initials': 'H', 'LastName': 'Luomajoki', 'Affiliation': 'ZHAW School of Health Professions, Technikumstrasse 71, 8400, Winterthur, Switzerland.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Brunner', 'Affiliation': 'ZHAW School of Management and Law, Winterthur Institute of Health Economics, Gertrudstrasse 15, 8401, Winterthur, Switzerland.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Dratva', 'Affiliation': 'ZHAW School of Health Professions, Technikumstrasse 71, 8400, Winterthur, Switzerland.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Sjøgaard', 'Affiliation': 'University of Southern Denmark, Department of Sport Sciences and Clinical Biomechanics, Odense, Denmark.'}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Elfering', 'Affiliation': 'University of Bern, Institute of Psychology, Fabrikstrasse 8, 3012, Bern, Switzerland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Melloh', 'Affiliation': 'ZHAW School of Health Professions, Technikumstrasse 71, 8400, Winterthur, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03388-x']
3003,32560724,"Effect of saroglitazar 2 mg and 4 mg on glycemic control, lipid profile and cardiovascular disease risk in patients with type 2 diabetes mellitus: a 56-week, randomized, double blind, phase 3 study (PRESS XII study).","BACKGROUND


The potential for PPAR agonists to positively affect risk of cardiovascular disease in patients with type 2 diabetes (T2DM) is of persistent attention. The PRESS XII study primarily aimed to evaluate the efficacy and safety of saroglitazar (2 mg and 4 mg) as compared to pioglitazone 30 mg on glycemic control in patients with type 2 diabetes mellitus.
METHODS


In this randomized double-blind study, patients with T2DM [glycosylated hemoglobin (HbA1c) ≥ 7.5%] were enrolled from 39 sites in India. Patients received once-daily doses of either saroglitazar or pioglitazone (1:1:1 allocation ratio) for a total of 24 weeks. Patients were continued in a double blind extension period for an additional 32 weeks. Efficacy evaluations of glycemic parameters [HbA1c (Primary endpoint at week 24), FPG and PPG] and other lipid parameters (TG, LDL-C, VLDL-C, HDL-C, TC, Non HDL-C, Apo A1 and Apo B) were conducted at week 12, 24 and 56 and compared to the baseline levels. The efficacy analyses were performed by using paired t-test and ANCOVA model.
RESULTS


A total of 1155 patients were enrolled in this study. The baseline characteristics were similar between the three treatment groups. The within group mean (± SD) change in HbA1c (%) from baseline of the saroglitazar (2 mg and 4 mg) and pioglitazone treatment groups at week 24 were: - 1.38 ± 1.99 for saroglitazar 2 mg; - 1.47 ± 1.92 for saroglitazar 4 mg and - 1.41 ± 1.86 for pioglitazone, respectively. Statistically significant reduction from baseline in HbA1c was observed in each treatment group at week 24 with p-value < 0.016. There was a significant reduction in TG, LDL-C, VLDL-C, TC and Non HDL-C with a significant increase in HDL-C from baseline levels (< 0.016). Most of the AE's were 'mild' to 'moderate' in severity and were resolved by the completion of the study.
CONCLUSIONS


Saroglitazar effectively improved glycemic control and lipid parameters over 56 weeks in patients of T2DM receiving background metformin therapy and has a promising potential to reduce the cardiovascular risk in T2DM patients. Trial registration CTRI/2015/09/006203, dated 22/09/2015.",2020,"There was a significant reduction in TG, LDL-C, VLDL-C, TC and Non HDL-C with a significant increase in HDL-C from baseline levels (< 0.016).","['patients with type 2 diabetes mellitus', 'patients with T2DM [glycosylated hemoglobin (HbA1c)\u2009≥\u20097.5%] were enrolled from 39 sites in India', 'patients with type 2 diabetes (T2DM', 'A total of 1155 patients were enrolled in this study', 'T2DM patients']","['pioglitazone', 'saroglitazar or pioglitazone', 'saroglitazar 2\xa0mg and 4\xa0mg', 'saroglitazar']","['FPG and PPG] and other lipid parameters (TG, LDL-C, VLDL-C, HDL-C, TC, Non HDL-C, Apo A1 and Apo B', 'cardiovascular risk', 'TG, LDL-C, VLDL-C, TC and Non HDL-C', 'glycemic control, lipid profile and cardiovascular disease risk', 'glycemic control and lipid parameters', 'HDL-C']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0071097', 'cui_str': 'pioglitazone'}]","[{'cui': 'C0049716', 'cui_str': ""6-thioguanosine 5'-diphosphate""}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0085201', 'cui_str': 'Apolipoprotein A-I'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",1155.0,0.113944,"There was a significant reduction in TG, LDL-C, VLDL-C, TC and Non HDL-C with a significant increase in HDL-C from baseline levels (< 0.016).","[{'ForeName': 'Manjunath', 'Initials': 'M', 'LastName': 'Krishnappa', 'Affiliation': 'Zydus Research Centre, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat, 382213, India. manjunath.k@zyduscadila.com.'}, {'ForeName': 'Kishor', 'Initials': 'K', 'LastName': 'Patil', 'Affiliation': 'Zydus Research Centre, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat, 382213, India.'}, {'ForeName': 'Krupi', 'Initials': 'K', 'LastName': 'Parmar', 'Affiliation': 'Zydus Research Centre, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat, 382213, India.'}, {'ForeName': 'Purav', 'Initials': 'P', 'LastName': 'Trivedi', 'Affiliation': 'Zydus Research Centre, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat, 382213, India.'}, {'ForeName': 'Nirali', 'Initials': 'N', 'LastName': 'Mody', 'Affiliation': 'Zydus Research Centre, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat, 382213, India.'}, {'ForeName': 'Chintan', 'Initials': 'C', 'LastName': 'Shah', 'Affiliation': 'Zydus Research Centre, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat, 382213, India.'}, {'ForeName': 'Khushboo', 'Initials': 'K', 'LastName': 'Faldu', 'Affiliation': 'Zydus Research Centre, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat, 382213, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Maroo', 'Affiliation': 'Zydus Research Centre, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat, 382213, India.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Deven', 'Initials': 'D', 'LastName': 'Parmar', 'Affiliation': 'Zydus Discovery DMCC, Dubai, UAE.'}]",Cardiovascular diabetology,['10.1186/s12933-020-01073-w']
3004,32560576,"Erratum: Dietary Intervention in Pregnant Women with Gestational Diabetes; Protocol for the DiGest Randomised Controlled Trial;  Nutrients  2020,  12 , 1165.",The authors would like to correct an error in a recent published paper [...].,2020,The authors would like to correct an error in a recent published paper [...].,['Pregnant Women with Gestational Diabetes'],['Erratum: Dietary Intervention'],[],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}]",[],,0.178666,The authors would like to correct an error in a recent published paper [...].,"[{'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Kusinski', 'Affiliation': 'Institute of Metabolic Science, University of Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Helen R', 'Initials': 'HR', 'LastName': 'Murphy', 'Affiliation': 'Cambridge Universities NHS Foundation Trust, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Emanuella De Lucia', 'Initials': 'EL', 'LastName': 'Rolfe', 'Affiliation': 'NIHR Cambridge Biomedical Research Centre - Diet, Anthropometry and Physical Activity Group, MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Kirsten L', 'Initials': 'KL', 'LastName': 'Rennie', 'Affiliation': 'NIHR Cambridge Biomedical Research Centre - Diet, Anthropometry and Physical Activity Group, MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Linda M Oude', 'Initials': 'LMO', 'LastName': 'Griep', 'Affiliation': 'NIHR Cambridge Biomedical Research Centre - Diet, Anthropometry and Physical Activity Group, MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Hughes', 'Affiliation': 'Institute of Metabolic Science, University of Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Taylor', 'Affiliation': 'Institute of Cellular Medicine, University of Newcastle, NE4 5PL, UK.'}, {'ForeName': 'Claire L', 'Initials': 'CL', 'LastName': 'Meek', 'Affiliation': 'Institute of Metabolic Science, University of Cambridge, CB2 0QQ, UK.'}]",Nutrients,['10.3390/nu12061793']
3005,32560632,"Study protocol of the HYPER-LIV01 trial: a multicenter phase II, prospective and randomized study comparing simultaneous portal and hepatic vein embolization to portal vein embolization for hypertrophy of the future liver remnant before major hepatectomy for colo-rectal liver metastases.","BACKGROUND


In patients undergoing major liver resection, portal vein embolization (PVE) has been widely used to induce hypertrophy of the non-embolized liver in order to prevent post-hepatectomy liver failure. PVE is a safe and effective procedure, but does not always lead to sufficient hypertrophy of the future liver remnant (FLR). Hepatic vein(s) embolization has been proposed to improve FLR regeneration when insufficient after PVE. The sequential right hepatic vein embolization (HVE) after right PVE demonstrated an incremental effect on the FLR but it implies two different procedures with no time gain as compared to PVE alone. We have developed the so-called liver venous deprivation (LVD), a combination of PVE and HVE during the same intervention, to optimize the phase of liver preparation before surgery. The main objective of this randomized phase II trial is to compare the percentage of change in FLR volume at 3 weeks after LVD or PVE.
METHODS


Patients eligible to this multicenter prospective randomized phase II study are subjects aged from 18 years old suffering from colo-rectal liver metastases considered as resectable and with non-cirrhotic liver parenchyma. The primary objective is the percentage of change in FLR volume at 3 weeks after LVD or PVE using MRI or CT-Scan. Secondary objectives are assessment of tolerance, post-operative morbidity and mortality, post-hepatectomy liver failure, rate of non-respectability due to insufficient FLR or tumor progression, per-operative difficulties, blood loss, R0 resection rate, post-operative liver volume and overall survival. Objectives of translational research studies are evaluation of pre- and post-operative liver function and determination of biomarkers predictive of liver hypertrophy. Sixty-four patients will be included (randomization ratio 1:1) to detect a difference of 12% at 21 days in FLR volumes between PVE and LVD.
DISCUSSION


Adding HVE to PVE during the same procedure is an innovative and promising approach that may lead to a rapid and major increase in volume and function of the FLR, thereby increasing the rate of resectable patients and limiting the risk of patient's drop-out.
TRIAL REGISTRATION


This study was registered on clinicaltrials.gov on 15th February 2019 (NCT03841305).",2020,The sequential right hepatic vein embolization (HVE) after right PVE demonstrated an incremental effect on the FLR but it implies two different procedures with no time gain as compared to PVE alone.,"['patients undergoing major liver resection', 'colo-rectal liver metastases', 'Patients eligible to this multicenter prospective randomized phase II study are subjects aged from 18\u2009years old suffering from colo-rectal liver metastases considered as resectable and with non-cirrhotic liver parenchyma']","['sequential right hepatic vein embolization (HVE', 'simultaneous portal and hepatic vein embolization to portal vein embolization', 'PVE', 'portal vein embolization (PVE']","['percentage of change in FLR volume', 'FLR regeneration', 'FLR volume', 'assessment of tolerance, post-operative morbidity and mortality, post-hepatectomy liver failure, rate of non-respectability due to insufficient FLR or tumor progression, per-operative difficulties, blood loss, R0 resection rate, post-operative liver volume and overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439687', 'cui_str': 'Non-cirrhotic'}, {'cui': 'C0736268', 'cui_str': 'Liver tissue'}]","[{'cui': 'C0226706', 'cui_str': 'Structure of right hepatic vein'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}, {'cui': 'C0019155', 'cui_str': 'Structure of hepatic vein'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0578122', 'cui_str': 'Embolization of portal vein'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0034963', 'cui_str': 'Regeneration'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0085605', 'cui_str': 'Hepatic failure'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0178874', 'cui_str': 'Tumor progression'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",64.0,0.0556545,The sequential right hepatic vein embolization (HVE) after right PVE demonstrated an incremental effect on the FLR but it implies two different procedures with no time gain as compared to PVE alone.,"[{'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Deshayes', 'Affiliation': 'Institut de Recherche en Cancérologie de Montpellier (IRCM), INSERM U1194, University of Montpellier, Institut régional du Cancer de Montpellier (ICM), Montpellier, France.'}, {'ForeName': 'Lauranne', 'Initials': 'L', 'LastName': 'Piron', 'Affiliation': 'Department of Radiology, Saint Eloi University Hospital, 80 avenue Augustin Fliche, F-34295, Montpellier, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Bouvier', 'Affiliation': 'Department of Radiology, Angers University Hospital, Angers, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Lapuyade', 'Affiliation': 'Department of Radiology, Bordeaux University Hospital, Bordeaux, France.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Lermite', 'Affiliation': 'Department of Liver surgery, Angers University Hospital, Angers, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Vervueren', 'Affiliation': 'Department of Nuclear Medicine, Angers University Hospital, Angers, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Laurent', 'Affiliation': 'Department of Liver surgery, Bordeaux University Hospital, Bordeaux, France.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Pinaquy', 'Affiliation': 'Department of Nuclear Medicine, Bordeaux University Hospital, Bordeaux, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Chevallier', 'Affiliation': 'Department of Radiology, Nice University Hospital, Nice, France.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Dohan', 'Affiliation': 'Department of Radiology, Assistance Publique - Hôpitaux de Paris, Cochin Hospital, Paris, France.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Rode', 'Affiliation': 'Department of Radiology, Croix Rousse Hospital, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sengel', 'Affiliation': 'Department of Radiology, Grenoble University Hospital, Grenoble, France.'}, {'ForeName': 'Chloé', 'Initials': 'C', 'LastName': 'Guillot', 'Affiliation': 'Department of Radiology, Saint Eloi University Hospital, 80 avenue Augustin Fliche, F-34295, Montpellier, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Quenet', 'Affiliation': 'Department of Surgery, Institut régional du Cancer de Montpellier (ICM), University of Montpellier, Montpellier, France.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Guiu', 'Affiliation': 'Department of Radiology, Saint Eloi University Hospital, 80 avenue Augustin Fliche, F-34295, Montpellier, France. b-guiu@chu-montpellier.fr.'}]",BMC cancer,['10.1186/s12885-020-07065-z']
3006,32560639,Combination of Ranibizumab with macular laser for macular edema secondary to branch retinal vein occlusion: one-year results from a randomized controlled double-blind trial.,"BACKGROUND


It is not clear whether macular laser combined with anti-vascular endothelial growth factor (VEGF) can reduce the number of anti-VEGF injections in the treatment of macular edema (ME) secondary to branch retinal vein occlusion (BRVO). Our study aimed to investigate the effects of intravitreal ranibizumab with or without macular laser for ME secondary to BRVO and its associated number of anti-VEGF injections.
METHODS


This is a prospective, randomized, double-blind, monocentric trial.80 patients were enrolled and 64 patients fulfilled the study requirements. All patients received a minimum of 3 initial monthly ranibizumab injections, pro re nata (PRN) dosing thereafter VA and CRT stabilization criteria-driven PRN treatment. Laser was given 7 days after third ranibizumab injection in ranibizumab with laser group. The follow-up time of this study was 1 year. Best corrected visual acuity (BCVA) improvement, central retinal thickness (CRT) reduction and number of injections of patients were compared between two groups. T-test, non-parametric Wilcoxon test and chis-square tests were adopted for between-group comparisons.
RESULTS


Thirty patients received intravitreal ranibizumab 0.5 mg alone and 34 patients received intravitreal ranibizumab 0.5 mg with macular laser. At 52 week, BCVA increased significantly and CRT decreased significantly in both groups (P < 0.001). However, there was no significant difference in BCVA improvement with baseline BCVA adjusted (p = 0.5226), and in the CRT reduction (P = 0.4552) between two groups after 52 weeks. There was also no significant difference in the number of injections between the two groups. (P = 0.0756). There was also no significant difference between ischemic and non-ischemic groups in BCVA improvement, CRT reduction and number of injections (P > 0.05).
CONCLUSIONS


Our study suggests that ranibizumab combined with macular laser is effective in the treatment of ME secondary to BRVO after 1 year of treatment with 3 + PRN regimen. However, combination of macular grid photocoagulation showed no beneficial anatomical or functional effect during follow-up period, nor did it reduce the number of ranibizumab injections, either in ischemic group or non-ischemic group. We suggest that there is no need to combine macular grid photocoagulation in the treatment of ME secondary to BRVO in the future.
TRIAL REGISTRATION


Clinical Trials NCT03054766. https://register.clinicaltrials.gov.Prospectively registered.",2020,"At 52 week, BCVA increased significantly and CRT decreased significantly in both groups (P < 0.001).","['monocentric trial.80 patients were enrolled and 64 patients fulfilled the study requirements', 'macular edema secondary to branch retinal vein occlusion']","['macular grid photocoagulation', 'intravitreal ranibizumab 0.5\u2009mg with macular laser', 'ranibizumab', 'Ranibizumab with macular laser', 'ranibizumab injection in ranibizumab with laser group', 'ranibizumab injections, pro re nata (PRN', 'intravitreal ranibizumab', 'macular laser combined with anti-vascular endothelial growth factor (VEGF']","['BCVA improvement, CRT reduction and number of injections', 'BCVA improvement', 'BCVA increased significantly and CRT', 'Best corrected visual acuity (BCVA) improvement, central retinal thickness (CRT) reduction and number of injections', 'beneficial anatomical or functional effect', 'CRT reduction', 'number of injections', 'T-test, non-parametric Wilcoxon test and chis-square tests']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0339505', 'cui_str': 'Venous retinal branch occlusion'}]","[{'cui': 'C1302035', 'cui_str': 'Grid photocoagulation'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C4050112', 'cui_str': 'ranibizumab Injection'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0067792', 'cui_str': 'N-acetyltryptophanamide'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205120', 'cui_str': 'Square'}]",,0.264013,"At 52 week, BCVA increased significantly and CRT decreased significantly in both groups (P < 0.001).","[{'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Song', 'Affiliation': ""Department of Ophthalmology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.""}, {'ForeName': 'Xiaobing', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': ""Department of Ophthalmology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People's Republic of China. yuxiaobing1214@163.com.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': ""Department of Ophthalmology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.""}, {'ForeName': 'Xiaoya', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': ""Department of Ophthalmology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Dai', 'Affiliation': ""Department of Ophthalmology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.""}]",BMC ophthalmology,['10.1186/s12886-020-01498-7']
3007,32560681,Independent Housing and Support for non-homeless individuals with severe mental illness: randomised controlled trial vs. observational study - study protocol.,"BACKGROUND


Social inclusion is essential for an adequate rehabilitation process for people with serious mental illness (SMI). Various supported housing settings aim to promote housing competencies and social inclusion in service users. Nevertheless, there is a strong preference in service users for independent living. We aim to evaluate the effectiveness and efficiency of Independent Housing and Support (IHS) compared to institutionalised residential care settings and other treatment as usual conditions (RCS/TAU) in two cities in Switzerland.
METHODS


This is a prospective multi-centre, four-arm, non-inferiority cohort study investigating the effectiveness and efficiency of IHS and RCS/TAU for people with SMI. Effectiveness will be measured by a standardised measure of social inclusion as primary outcome as well as by measures of functioning and well-being. Efficiency will be analysed on the basis of service usage and costs associated with the different housing settings. Participants will be consecutively recruited and subsequently enrolled between April 2019 and December 2020 and assessed at baseline and after six, twelve and after 24 months. At one study site, 56 participants will be randomly assigned to one of the conditions; the other study site will be conducted as an observational study investigating 112 admitted participants.
DISCUSSION


While the UN Convention of the Rights of People with Disabilities aims to promote the opportunity to choose one's place of residence, the limited supply of alternative forms of housing does not guarantee genuine freedom of choice. Increased diversification and flexibility of housing support is essential. If IHS shows non-inferiority in terms of their effectiveness and efficiency, users should be allowed to choose their kind of housing support.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03815604, December 04, 2019.",2020,"We aim to evaluate the effectiveness and efficiency of Independent Housing and Support (IHS) compared to institutionalised residential care settings and other treatment as usual conditions (RCS/TAU) in two cities in Switzerland.
","['Participants will be consecutively recruited and subsequently enrolled between April 2019 and December 2020 and assessed at baseline and after six, twelve and after 24\u2009months', 'service users', 'people with serious mental illness (SMI', 'non-homeless individuals with severe mental illness', 'two cities in Switzerland', 'people with SMI', '56 participants will be randomly assigned to one of the conditions; the other study site will be conducted as an observational study investigating 112 admitted participants']","['IHS and RCS/TAU', 'Housing and Support (IHS']",[],"[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0425242', 'cui_str': 'Homeless single person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",[],112.0,0.238054,"We aim to evaluate the effectiveness and efficiency of Independent Housing and Support (IHS) compared to institutionalised residential care settings and other treatment as usual conditions (RCS/TAU) in two cities in Switzerland.
","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Adamus', 'Affiliation': 'Center for Psychiatric Rehabilitation, Universitäre Psychiatrische Dienste Bern (UPD), Murtenstrasse 46, CH-3008, Bern, Switzerland. christine.adamus@upd.unibe.ch.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Mötteli', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital of Psychiatry Zurich, Zurich, Switzerland.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Jäger', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital of Psychiatry Zurich, Zurich, Switzerland.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Richter', 'Affiliation': 'Center for Psychiatric Rehabilitation, Universitäre Psychiatrische Dienste Bern (UPD), Murtenstrasse 46, CH-3008, Bern, Switzerland.'}]",BMC psychiatry,['10.1186/s12888-020-02712-y']
3008,32560745,"Letter to the editor: efficacy of different methods of combination regimen administrations including dexamethasone, intravenous immunoglobulin, and interferon-beta to treat critically ill COVID-19 patients: a structured summary of a study protocol for a randomized controlled trial.","OBJECTIVES


There is little information about Coronavirus Disease 2019 (COVID-19) management for critically ill patients. Most of these patients develop acute respiratory distress syndrome (ARDS) due to excessive inflammatory response and the ensuing cytokine storm. Anti-inflammatory drugs including corticosteroids can be used to effectively reduce the effect of this cytokine storm and lung damage. However, corticosteroids can have side effects, so simultaneous administration of immunoglobulin (IV-IG) and interferon-beta can help manage treatment using corticosteroids. Therefore, we designed a trial to test our hypothesis that early administration of dexamethasone in combination with IV-IG and interferon-beta can reduce the effect of the cytokine storm in critically ill patients COVID-19.
TRIAL DESIGN


A phase two multi-center randomized controlled trial (RCT) with three parallel arms (1:1:1 ratio).
PARTICIPANTS


They will be hospitalized patients with severe COVID-19 who have positive RT-PCR test and have blood oxygen saturation levels (SpO 2 ) less than 90% and respiratory rate higher than 24 per minute or have involvement of more than 50% of their lung when viewed using computed tomography (CT)-scan. The age range of patients will be 18-70 years old.
EXCLUSION CRITERIA


the need for intubation; allergy, intolerance, or contraindication to any study drug including dexamethasone, IV-IG, and interferon-beta; pregnancy or lactation; known HIV positive or active hepatitis B or C. The study will be conducted in several hospitals of the Golestan province, Iran.
INTERVENTION AND COMPARATOR


The study subjects will be randomly allocated to three treatment arms: two experimental groups (two arms: Intervention 1 and Intervention 2) and one Control Group, which will be matched for age and sex using frequency matching method. Each eligible patient in the control arm will receive the standard treatment for COVID-19 based on WHO guidelines and the Ministry of the Health and Medical Education (MOHME) of Iran. Each patient in the Intervention Group 1 will receive the standard treatment for COVID-19 and dexamethasone, at the first 24 hours' time of admission. The intervention begins with the administration of dexamethasone based on the SpO 2  levels. If the level of SpO 2  does not improve after 24 hours, IV-IG (400 mg/kg once daily for 5 days) and interferon-beta (7 doses every other day) will be prescribed along with dexamethasone administration. In Intervention Group 2, the administration of dexamethasone will be started within the first 24 hours' time of admission and will be continued for 48-72 hours and then the SpO 2  level will be checked. Then, if the level of SpO 2  has not improved after that time, IV-IG and interferon-beta will be prescribed as the same dosage as Group 1. If the percentages of the SpO 2  level are between 85 and 90/ 80 and 85/ 75 and 80/ less than 75, the dosages will be 4 mg every 12 hours/ 4 mg every 8 hours/ 8 mg every 12 hours/ 8 mg every 8 hours, respectively. According to the WHO recommendation, all participants will have the best available supportive care with full monitoring.
MAIN OUTCOMES


Primary: An increase in the SpO 2  level to reach more than 90% in each case, which will be assessed by the oximeter. Secondary: The duration of hospital stays; intubation status and the percentage of patients who are free of mechanical ventilation; the mortality rates during hospitalization and one month after the admission time.
RANDOMISATION


Participants will be allocated into either control or intervention groups with a 1:1:1 allocation ratio using a computer random number generator to generate a table of random numbers for simple randomization.
BLINDING (MASKING)


The project's principal investigator (PI) is unblinded. However, the PI will not analyse the data and interpret the results. An unblinded researcher (a pharmacist) will cover the drug's bottles with aluminium foil and prepare them interventions and control drugs in a syringe with a code so that patients are blinded. This person will have no patients contact. The staff and nurses, caring for the patients, will be unblinded for each study group due to the nature of this study. The staff that take outcome measurements will be blinded. The laboratory technicians will also be blinded as well as the statistical team. These study statisticians will have access to coded data and will analyse the data labelled as group X, group Y, and group Z.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


The target sample size will be 105 critically ill COVID-19 patients, who will be allocated randomly to the three trial arms with 35 patients in each group.
TRIAL STATUS


Recruitment is ongoing. The study began on April 18 2020 and will be completed June 19 2020. This summary describes protocol version 1; April 2 2020.
TRIAL REGISTRATION


https://www.irct.ir/. Identifier: IRCT20120225009124N4 version 1; Registration date: April 2 2020.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting the dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The full protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines.",2020,"If the level of SpO 2  does not improve after 24 hours, IV-IG (400 mg/kg once daily for 5 days) and interferon-beta (7 doses every other day) will be prescribed along with dexamethasone administration.","['hospitalized patients with severe COVID-19 who have positive RT-PCR test and have blood oxygen saturation levels (SpO 2 ) less than 90% and respiratory rate higher than 24 per minute or have involvement of more than 50% of their lung when viewed using computed tomography (CT)-scan', 'critically ill patients', 'critically ill COVID-19 patients', '105 critically ill COVID-19 patients', 'critically ill patients COVID-19', 'The study began on April 18 2020 and will be completed June 19 2020', 'several hospitals of the Golestan province, Iran', 'patients develop acute respiratory distress syndrome (ARDS']","['standard treatment for COVID-19 based on WHO guidelines and the Ministry of the Health and Medical Education (MOHME) of Iran', 'dexamethasone, intravenous immunoglobulin, and interferon-beta', 'dexamethasone', 'corticosteroids', 'standard treatment for COVID-19 and dexamethasone']",['duration of hospital stays; intubation status and the percentage of patients who are free of mechanical ventilation; the mortality rates during hospitalization and one month after the admission time'],"[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1720477', 'cui_str': 'When'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013631', 'cui_str': 'Medical Education'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0015980', 'cui_str': 'Interferon-beta'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",105.0,0.199707,"If the level of SpO 2  does not improve after 24 hours, IV-IG (400 mg/kg once daily for 5 days) and interferon-beta (7 doses every other day) will be prescribed along with dexamethasone administration.","[{'ForeName': 'Nafiseh', 'Initials': 'N', 'LastName': 'Abdolahi', 'Affiliation': 'Golestan Rheumatology Research Center, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Effat', 'Initials': 'E', 'LastName': 'Kaheh', 'Affiliation': 'Golestan Rheumatology Research Center, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Roghieh', 'Initials': 'R', 'LastName': 'Golsha', 'Affiliation': 'Infectious Diseases Research Center, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Behnaz', 'Initials': 'B', 'LastName': 'Khodabakhshi', 'Affiliation': 'Infectious Diseases Research Center, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Norouzi', 'Affiliation': 'Golestan Research Center of Gastroenterology and Hepatology, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Khandashpoor', 'Affiliation': 'Clinical Research Development Center (CRDC), Sayad Shirazi Hospital, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Besharat', 'Affiliation': 'Infectious Diseases Research Center, Golestan University of Medical Sciences, Gorgan, Iran. s_besharat_gp@yahoo.com.'}, {'ForeName': 'Samane', 'Initials': 'S', 'LastName': 'Tavassoli', 'Affiliation': 'Golestan Rheumatology Research Center, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Livani', 'Affiliation': 'Clinical Research Development Center (CRDC), Sayad Shirazi Hospital, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Sadegh Ali', 'Initials': 'SA', 'LastName': 'Azimi', 'Affiliation': 'Infectious Diseases Research Center, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Mohammad Hadi', 'Initials': 'MH', 'LastName': 'Gharib', 'Affiliation': 'Golestan Rheumatology Research Center, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Peivandi', 'Affiliation': 'Clinical Research Development Center (CRDC), Sayad Shirazi Hospital, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Abdolreza', 'Initials': 'A', 'LastName': 'Fazel', 'Affiliation': 'Cancer Research Center, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Hesamaddin', 'Initials': 'H', 'LastName': 'Shirzad-Aski', 'Affiliation': 'Infectious Diseases Research Center, Golestan University of Medical Sciences, Gorgan, Iran. shirzad.hessam1364@gmail.com.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Roshandel', 'Affiliation': 'Golestan Research Center of Gastroenterology and Hepatology, Golestan University of Medical Sciences, Gorgan, Iran. roshandel_md@yahoo.com.'}]",Trials,['10.1186/s13063-020-04499-5']
3009,32560746,Efficacy and safety of aerosolized intra-tracheal dornase alfa administration in patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS): a structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) may trigger severe pneumonia in coronavirus disease of 2019 (COVID-19) patients through release of damage-associated molecular patterns (DAMPs) and recruitment of neutrophils in the lungs. Activated neutrophils induce inflammation and severe alveolar injury by releasing neutrophil extracellular traps (NETs). The backbones of many DAMPs and NETs are made of extracellular, cell-free DNA decorated with highly toxic compounds such as elastase, myeloperoxidase and citrullinated histones. Dornase alfa is a FDA-approved recombinant human DNAse 1 for the treatment of cystic fibrosis, which cleaves extracellular DNA and may break up cell-free DNA, loosening sticky mucus in the distal airways and reducing NETs-induced toxicity on alveolar pneumocytes. The COVIDornase trial intends to define the impact of aerosolized intra-tracheal dornase alfa administration on the severity and progression of acute respiratory distress syndrome (ARDS) in COVID-19 patients. This drug might make lung mucus thinner and looser, promoting improved clearance of secretions and reduce extracellular double-stranded DNA-induced hyperinflammation in alveoli, preventing further damage to the lungs.
TRIAL DESIGN


COVIDornase is a prospective, randomized, controlled, 2-arm (1:1 ratio), multicentric, open-label clinical trial.
PARTICIPANTS


The study will recruit mechanically ventilated patients hospitalized in the intensive care unit (ICU) in the recruiting centres (at the time of writing: The Rothschild foundation hospital in Paris, the Strasbourg university hospitals, and Metz-Thionville hospital) who have been diagnosed with COVID-19 and meet ARDS criteria.
INCLUSION CRITERIA


- Adult patient (age ≥ 18 years old); - Hospitalized in ICU; - With severe COVID-19 pneumonia and ARDS according to Berlin criteria (PaO 2 /FiO 2  < 300 and PEEP > 5 cmH 2 O); - Intubated for less than 8 days; - With an anticipated duration of mechanical ventilation > 48 hours; - Carrier of an arterial catheter; - For whom 4 PaO 2 /FiO 2  values over the preceding 24 hours are available; NON-INCLUSION CRITERIA: - Known hypersensitivity to dornase alfa or any of its excipients; - Pregnant or breastfeeding status; - Patient under legal protection.
INTERVENTION AND COMPARATOR


Intervention 1, Study group Dornase alfa (Pulmozyme®, Roche, Switzerland) will be administered by aerosol, at a dose of 2500 IU twice daily, 12 hours apart, for 7 consecutive days, using a vibrating mesh nebulizer (Aerogen Solo®, Aerogen, Ireland). The remainder of the management will be performed in accordance with good clinical practice, including mechanical ventilation (protective ventilation, PEEP > 5 cmH 2 O, tracheal balloon pressure check every 4 hours or automatic device, 30° head of the bed elevation, tidal volume 6-8mL/kg, plateau pressure < 30 cmH 2 O), neuromuscular blockers if necessary, prone position if PaO 2 /FiO 2  < 150, early enteral nutrition, glycemic control and a sedation protocol based on the RASS score. Intervention 2, Comparator Patients will receive usual care in accordance with good practice (as detailed above), without aerosols.
MAIN OUTCOMES


The primary outcome is the occurrence of at least one grade improvement between D 0  (inclusion) and D 7  in the ARDS scale severity (Berlin criteria). For instance from ""severe"" to ""moderate"" or from ""moderate"" to ""mild"".
RANDOMISATION


All consecutive patients meeting the inclusion criteria will be randomised 1:1 using an eCRF-based, computer-generated randomisation table, either to the dornase alfa arm or to the control arm. An interim analysis will be performed after inclusion of 20 patients. Inclusions may be stopped at the interim analysis per data safety and monitoring board (DSMB) advice, if statistical analyses conclude on the futility or efficacy of the intervention or by other DSMB decision.
BLINDING (MASKING)


The participants and caregivers will not be blinded to study group assignment. Those assessing the outcomes will be blinded to study group assignment.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


Fifty patients will be randomized to each group, 100 patients in total.
TRIAL STATUS


Protocol version number 2, April 29 th , 2020. Recruitment is ongoing. The trial started recruitment on the 21 st  April 2020. We estimate recruitment will finish August 21 st  2020.
TRIAL REGISTRATION


The trial was registered in ClinicalTrials.gov on 21 April 2020, updated on 8 May 2020. Trial registration number is NCT04355364.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated. This Letter serves as a summary of the key elements of the full protocol.",2020,"This drug might make lung mucus thinner and looser, promoting improved clearance of secretions and reduce extracellular double-stranded DNA-induced hyperinflammation in alveoli, preventing further damage to the lungs.
","[' Adult patient (age ≥ 18 years old); - Hospitalized in ICU; - With severe COVID-19 pneumonia and ARDS according to Berlin criteria (PaO 2 /FiO 2  < 300 and PEEP > 5 cmH 2 O', 'COVID-19 patients', 'Protocol version number 2, April 29 th , 2020', 'Fifty patients will be randomized to each group, 100 patients in total', 'mechanically ventilated patients hospitalized in the intensive care unit (ICU) in the recruiting centres (at the time of writing: The Rothschild foundation hospital in Paris, the Strasbourg university hospitals, and Metz-Thionville hospital) who have been diagnosed with COVID-19 and meet ARDS criteria', 'patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS', '21 April 2020, updated on 8 May 2020']","['aerosolized intra-tracheal dornase alfa administration', 'Dornase alfa (Pulmozyme®, Roche, Switzerland', 'Comparator Patients will receive usual care in accordance with good practice (as detailed above), without aerosols']","['occurrence of at least one grade improvement between D 0  (inclusion) and D 7  in the ARDS scale severity (Berlin criteria', 'Efficacy and safety', 'severity and progression of acute respiratory distress syndrome (ARDS']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0949658', 'cui_str': 'Primary familial hypertrophic cardiomyopathy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030561', 'cui_str': 'Paris'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C2945595', 'cui_str': 'Tracheal'}, {'cui': 'C1135662', 'cui_str': 'Dornase Alfa'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0251564', 'cui_str': 'Pulmozyme'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C0001712', 'cui_str': 'Aerosol'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",50.0,0.257936,"This drug might make lung mucus thinner and looser, promoting improved clearance of secretions and reduce extracellular double-stranded DNA-induced hyperinflammation in alveoli, preventing further damage to the lungs.
","[{'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Desilles', 'Affiliation': 'Biological Resource Center, Interventional Neuroradiology Department, Rothschild Foundation Hospital, Paris, France. jpdesilles@for.paris.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gregoire', 'Affiliation': 'Intensive Care Department, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Le Cossec', 'Affiliation': 'Clinical Research Unit, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lambert', 'Affiliation': 'Clinical Research Unit, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Mophawe', 'Affiliation': 'Clinical Research Unit, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Losser', 'Affiliation': ""CHRU Nancy, Pôle d'Anesthésie-Réanimation, 29 Avenue de Lattre de Tassigny, 54000, Nancy, France.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Lambiotte', 'Affiliation': 'Service de Réanimation Polyvalente, Centre Hospitalier de Valenciennes, Avenue Désandrouin, 59322, Valenciennes, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Le Tacon', 'Affiliation': 'CHR Metz-Thionville-Site de Mercy, Service de Réanimation Polyvalente, 1 Allée du Château, 57350, Ars-Laquenexy, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cantier', 'Affiliation': 'Intensive Care Department, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Engrand', 'Affiliation': 'Intensive Care Department, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Trouiller', 'Affiliation': 'Intensive Care Department, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Pottecher', 'Affiliation': ""Hôpitaux Universitaires de Strasbourg, Hôpital de Hautepierre, Service d'Anesthésie-Réanimation Chirurgicale, 1 Avenue Molière, 67098, Strasbourg, France.""}]",Trials,['10.1186/s13063-020-04488-8']
3010,32560872,The immediate effects of pelvic compression belt with a textured sacral pad on the sacroiliac function in pregnant women with lumbopelvic pain: A cross-over study.,"BACKGROUND


Pelvic belt is being used to alleviate the symptoms of lumbopelvic pain.
OBJECTIVE


To investigate the immediate effects of a pelvic belt with a textured sacral pad in pregnant women with lumbopelvic pain.
METHODS


Twenty-eight pregnant women participated in a randomized crossover study. Hip joint position sense, maximum hip flexion force, and perceived effort during the active straight leg raising test were measured in twenty-eight pregnant women with lumbopelvic pain. Outcomes were measured in three randomized conditions including no pelvic belt (control), with a pelvic belt, and while a sacral pad was used with the pelvic belt. Data were analyzed using a one-way repeated measures analysis of variance for each variable.
RESULTS


Improvements in all study outcomes have been shown with a pelvic belt compared with the control condition. The addition of a textured sacral pad to the pelvic belt improved all study outcomes compared with the pelvic belt: hip joint position sense (p < 0.001; 95% confidence interval:1.3to2.3), perceived effort (p = 0.003; 95% confidence interval: 0.35 to 1.86), and maximum flexion force (p < 0.001; 95% confidence interval:2.77to6.47) in the active straight leg raising.
CONCLUSION


Further improvements were noted with the addition of the textured pad for all outcome measures. This finding may inform new benefits in adding a textured sacral pad to pelvic compression belts.",2020,"Hip joint position sense, maximum hip flexion force, and perceived effort during the active straight leg raising test were measured in twenty-eight pregnant women with lumbopelvic pain.","['pregnant women with lumbopelvic pain', 'Twenty-eight pregnant women participated', 'twenty-eight pregnant women with lumbopelvic pain']","['pelvic belt with a textured sacral pad', 'pelvic compression belt with a textured sacral pad']","['sacroiliac function', 'Hip joint position sense, maximum hip flexion force, and perceived effort', 'maximum flexion force']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4283787', 'cui_str': '28'}]","[{'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0452227', 'cui_str': 'Belt'}, {'cui': 'C0036037', 'cui_str': 'Bone structure of sacrum'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0332459', 'cui_str': 'Compression'}]","[{'cui': 'C0555898', 'cui_str': 'Sacroiliac'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0234219', 'cui_str': 'Postural sense'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]",28.0,0.208761,"Hip joint position sense, maximum hip flexion force, and perceived effort during the active straight leg raising test were measured in twenty-eight pregnant women with lumbopelvic pain.","[{'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Delshad', 'Affiliation': 'Student Research Committee, School of Rehabilitation Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Elaheh', 'Initials': 'E', 'LastName': 'Zarean', 'Affiliation': 'Department of Obstetrics and Gynecology, Feto-maternal Medicine Unit, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Yeowell', 'Affiliation': 'Department of Health Professions, Manchester Metropolitan University, Manchester, UK.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Sadeghi-Demneh', 'Affiliation': 'Musculoskeletal Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: sadeghi@rehab.mui.ac.ir.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102170']
3011,32560911,"Effect of mental rotation skills training on ultrasound-guided regional anaesthesia task performance by novice operators: a rater-blinded, randomised, controlled study.","BACKGROUND


The effect of mental rotation training on ultrasound-guided regional anaesthesia (UGRA) skill acquisition is currently unknown. In this study we aimed to examine whether mental rotation skill training can improve UGRA task performance by novice operators.
METHODS


We enrolled 94 volunteers with no prior experience of UGRA in this randomised controlled study. After a baseline mental rotation test, their performance in a standardised UGRA needling task was independently assessed by two raters using the composite error score (CES) and global rating scale (GRS). Volunteers with low baseline mental rotation ability were randomised to a mental rotation training group or a no training group, and the UGRA needling task was repeated to determine the impact of the training intervention on task performance. The study primary outcome measure was UGRA needling task CES measured before and after the training intervention.
RESULTS


Multivariate analyses controlling for age, gender, and previous performance showed that participants exposed to the training intervention made significantly fewer errors (CES B=-0.66 [standard error, se=0.17]; P<0.001; 95% confidence interval [CI], -0.92 to -0.26) and displayed improved overall performance (GRS B=6.15 [se=2.99], P=0.048, 95% CI=0.06 to 12.13) when undertaking the UGRA needling task.
CONCLUSIONS


A simple training intervention, based on the manipulation and rotation of three-dimensional models, results in improved technical performance of a UGRA needling task in operators with low baseline mental rotation skills.",2020,"A simple training intervention, based on the manipulation and rotation of three-dimensional models, results in improved technical performance of a UGRA needling task in operators with low baseline mental rotation skills.","['94 volunteers with no prior experience of UGRA', 'in operators with low baseline mental rotation skills', 'Volunteers with low baseline mental rotation ability', 'ultrasound-guided regional anaesthesia task performance by novice operators']","['UGRA needling task', 'mental rotation training group or a no training group, and the UGRA needling task', 'mental rotation skills training', 'mental rotation training', 'mental rotation skill training']","['UGRA task performance', 'composite error score (CES) and global rating scale (GRS', 'UGRA needling task CES', 'overall performance']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",94.0,0.202241,"A simple training intervention, based on the manipulation and rotation of three-dimensional models, results in improved technical performance of a UGRA needling task in operators with low baseline mental rotation skills.","[{'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Hewson', 'Affiliation': 'Department of Anaesthesia, Nottingham University Hospitals NHS Trust, Nottingham, UK. Electronic address: david.hewson@nottingham.ac.uk.'}, {'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Knudsen', 'Affiliation': 'Department of Anaesthesia, Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'Sanjeevan', 'Initials': 'S', 'LastName': 'Shanmuganathan', 'Affiliation': 'Department of Anaesthesia, Royal National Orthopaedic Hospital, Stanmore, UK.'}, {'ForeName': 'Eamonn', 'Initials': 'E', 'LastName': 'Ferguson', 'Affiliation': 'Personality, Social Psychology and Health Research Group, School of Psychology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Jonathan G', 'Initials': 'JG', 'LastName': 'Hardman', 'Affiliation': 'Department of Anaesthesia, Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'Nigel M', 'Initials': 'NM', 'LastName': 'Bedforth', 'Affiliation': 'Department of Anaesthesia, Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'Rob A', 'Initials': 'RA', 'LastName': 'McCahon', 'Affiliation': 'Department of Anaesthesia, Nottingham University Hospitals NHS Trust, Nottingham, UK.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.04.090']
3012,32560926,Accuracy of diagnostic judgments using ICD-11 vs. ICD-10 diagnostic guidelines for obsessive-compulsive and related disorders.,"BACKGROUND


We report results of an internet-based field study evaluating the diagnostic guidelines for the newly introduced ICD-11 grouping of obsessive-compulsive and related disorders (OCRD). We examined accuracy of clinicians' diagnostic judgments applying draft ICD-11 as compared to the ICD-10 diagnostic guidelines to standardized case vignettes.
METHODS


1,717 mental health professionals who are members of the World Health Organization's Global Clinical Practice Network completed the study in Chinese, English, French, Japanese, Russian or Spanish. Participants were randomly assigned to apply ICD-11 or ICD-10 guidelines to one of nine pairs of case vignettes.
RESULTS


Participants using ICD-11 outperformed those using ICD-10 in correctly identifying newly introduced OCRD, although results were mixed for differentiating OCRD from disorders in other groupings largely due to clinicians having difficulty differentiating challenging presentations of OCD. Clinicians had difficulty applying a three-level insight qualifier, although the 'poor to absent' level assisted with differentiating OCRD from psychotic disorders. Brief training on the rationale for an OCRD grouping did not improve diagnostic accuracy suggesting sufficient detail of the proposed guidelines.
LIMITATIONS


Standardized case vignettes were manipulated to include specific characteristics; the degree of accuracy of clinicians' diagnostic judgments about these vignettes may not generalize to application in routine clinical practice.
CONCLUSIONS


Overall, use of the ICD-11 guidelines resulted in more accurate diagnosis of case vignettes compared to the ICD-10 guidelines, particularly in differentiating OCRD presentations from one another. Specific areas in which the ICD-11 guidelines did not perform as intended provided the basis for further revisions to the guidelines.",2020,"Participants were randomly assigned to apply ICD-11 or ICD-10 guidelines to one of nine pairs of case vignettes.
","[""1,717 mental health professionals who are members of the World Health Organization's Global Clinical Practice Network completed the study in Chinese, English, French, Japanese, Russian or Spanish""]","['ICD-11 vs. ICD-10 diagnostic guidelines', 'ICD-11 or ICD-10 guidelines']",[],"[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0035967', 'cui_str': 'Russian language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}]","[{'cui': 'C4704940', 'cui_str': 'ICD-11'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]",[],1717.0,0.0236793,"Participants were randomly assigned to apply ICD-11 or ICD-10 guidelines to one of nine pairs of case vignettes.
","[{'ForeName': 'Cary S', 'Initials': 'CS', 'LastName': 'Kogan', 'Affiliation': 'School of Psychology, Faculty of Social Sciences, 136 Jean-Jacques Lussier, Vanier Hall, Ottawa, ON K1N 6N5, Canada. Electronic address: ckogan@uottawa.ca.'}, {'ForeName': 'Dan J', 'Initials': 'DJ', 'LastName': 'Stein', 'Affiliation': 'SAMRC Unit on Risk & Resilience in Mental Disorders, University of Cape Town Dept of Psychiatry & Neuroscience Institute, Groote Schuur Hospital, J-Block, Anzio Road, Observatory 7925, Cape Town, South Africa. Electronic address: dan.stein@uct.ac.za.'}, {'ForeName': 'Tahilia J', 'Initials': 'TJ', 'LastName': 'Rebello', 'Affiliation': 'Global Mental Health Program, Columbia University College of Physicians and Surgeons and New York State Psychiatric Institute, Mailman School of Public Health, 722 West 168th, Floor R2, R-233, New York, NY 10032, USA. Electronic address: Tahilia.Rebello@nyspi.columbia.edu.'}, {'ForeName': 'Jared W', 'Initials': 'JW', 'LastName': 'Keeley', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, 806 West Franklin St, Box 842018, Richmond, VA 23284, USA. Electronic address: jwkeeley@vcu.edu.'}, {'ForeName': 'K Jacky', 'Initials': 'KJ', 'LastName': 'Chan', 'Affiliation': 'School of Psychology, Faculty of Social Sciences, 136 Jean-Jacques Lussier, Vanier Hall, Ottawa, ON K1N 6N5, Canada. Electronic address: jacky.chan@uottawa.ca.'}, {'ForeName': 'Naomi A', 'Initials': 'NA', 'LastName': 'Fineberg', 'Affiliation': 'Highly Specialized Obsessive Compulsive and Related Disorders Service, Hertfordshire Partnership University NHS Foundation Trust, Rosanne House, Welwyn Garden City, UK; Postgraduate Medical School, University of Hertfordshire, Hatfield, UK; University of Cambridge School of Clinical Medicine, Cambridge, UK. Electronic address: naomi.fineberg@btinternet.com.'}, {'ForeName': 'Leonardo F', 'Initials': 'LF', 'LastName': 'Fontenelle', 'Affiliation': 'Institute of Psychiatry, Federal University of Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil; ""D\'Or\' Institute for Research and Education, Rio de Janeiro, RJ, Brazil; School of Psychological Sciences, Monash University, Melbourne, Australia. Electronic address: lfontenelle@gmail.com.'}, {'ForeName': 'Jon E', 'Initials': 'JE', 'LastName': 'Grant', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA. Electronic address: jgrant4@bsd.uchicago.edu.'}, {'ForeName': 'Hisato', 'Initials': 'H', 'LastName': 'Matsunaga', 'Affiliation': 'Department of Neuropsychiatry, Hyogo College of Medicine, 1-1 Mukogawa-cho, Nishinomiya Hyogo, Japan. Electronic address: hisa1311@hyo-med.ac.jp.'}, {'ForeName': 'H Blair', 'Initials': 'HB', 'LastName': 'Simpson', 'Affiliation': 'College of Physicians and Surgeons, Columbia University, New York, NY, USA; Anxiety Disorders Clinic and the Center for OCD and Related Disorders, New York State Psychiatric Institute, New York, NY, USA. Electronic address: hbs1@columbia.edu.'}, {'ForeName': 'Per Hove', 'Initials': 'PH', 'LastName': 'Thomsen', 'Affiliation': 'Department for Child and Adolescent Psychiatry, Aarhus University Hospital, Skejby, Aarhus, Denmark. Electronic address: per.hove.thomsen@ps.rm.dk.'}, {'ForeName': 'Odile A', 'Initials': 'OA', 'LastName': 'van den Heuvel', 'Affiliation': 'Amsterdam University Medical Centers, Vrije Universiteit, Department of Psychiatry and Department of Anatomy & Neurosciences, Amsterdam Neuroscience, Amsterdam, the Netherlands. Electronic address: oa.vandenheuvel@amsterdamumc.nl.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Veale', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK; Center for Anxiety Disorders and Trauma, South London and Maudsley NHS Foundation Trust, London, UK. Electronic address: david.veale@kcl.ac.uk.""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Grenier', 'Affiliation': ""Institut du Savoir Montfort - Hôpital Montfort and Université d'Ottawa, Ottawa, Ontario, Canada. Electronic address: jeangrenier@montfort.on.ca.""}, {'ForeName': 'Mayya', 'Initials': 'M', 'LastName': 'Kulygina', 'Affiliation': 'Alekseev Mental Health Clinic, No. 1, Education Centre, Moscow, Russian Federation. Electronic address: mkulygina@yandex.ru.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Matsumoto', 'Affiliation': 'National Study Coordinator for ICD-11 Field Studies, ICD-11 Committee, Japanese Society of Psychiatry and Neurology, Hongo-Yumicho Building, 2-38-4, Hongo, Bunkyo-ku, Tokyo 113-0033. Japan. Electronic address: c.matsumoto@outlook.jp.'}, {'ForeName': 'Tecelli', 'Initials': 'T', 'LastName': 'Domínguez-Martínez', 'Affiliation': 'Center for Research on Global Mental Health, Direction of Epidemiology and Psychosocial Research, National Institute of Psychiatry ""Ramón de la Fuente Muñiz"", Mexico City, Mexico. Electronic address: tecelli.dominguez@gmail.com.'}, {'ForeName': 'Anne-Claire', 'Initials': 'AC', 'LastName': 'Stona', 'Affiliation': 'Lee Kong Chian School of Medicine, Nanyang Technological University, 11 Mandalay Road, Singapore. Electronic address: anne.claire.s@gmail.com.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, 600 Wan Ping Nan Road, Shanghai 200030, PR China. Electronic address: wangzhen@smhc.org.cn.'}, {'ForeName': 'Geoffrey M', 'Initials': 'GM', 'LastName': 'Reed', 'Affiliation': 'Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, 1051 Riverside Drive, New York, NY \xa010032, USA; Department of Mental Health and Substance Abuse, World Health Organization, Geneva, Switzerland. Electronic address: gmr2142@cumc.columbia.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.03.103']
3013,32560932,Vascular endothelial growth factor and pigment epithelial-derived factor in the peripheral response to ketamine.,"BACKGROUND


Ketamine is a rapid-acting antidepressant but its mechanism remains unclear. Vascular endothelial growth factor growth factor (VEGF) has been reported in the antidepressant action of ketamine in rodents. VEGF and pigment epithelial-derived factor (PEDF) signalling are closely linked and both are dysregulated in depression. We explored the effect of a single infusion of ketamine, with midazolam as comparison, on peripheral whole blood mRNA levels of vascular endothelial growth factor A (VEGFA) and PEDF, and the VEGFA/PEDF ratio, in patients with depression.
METHODS


Twenty-five patients with depression were randomised to either ketamine (0.5 mg/kg) or midazolam (0.045 mg/kg) infusions over 40 min. Blood plasma samples were taken 1 h before the first infusion and 4 h after the infusion start. mRNA was extracted and qRT-PCR performed to analyse gene expression.
RESULTS


Single infusions of ketamine and midazolam both decreased depression scores (F(1,21) = 102.40, p < 0.000). There was a significant group × time interaction for VEGFA mRNA levels (F(1, 21) = 5.207, p = 0.029), with ketamine increasing VEGFA levels. There was no significant effect of either ketamine or midazolam on PEDF levels. There was a significant group × time interaction for VEGFA/PEDF mRNA ratio, with ketamine alone increasing this ratio (F(1, 11) = 12.085, p = 0.005).
LIMITATIONS


Patients were on psychotropic medication and continued treatment as usual throughout the study.
CONCLUSIONS


These preliminary results support a role for VEGF in the action of ketamine and suggest a novel role for VEGF/PEDF in the molecular response to ketamine.",2020,"There was a significant group × time interaction for VEGFA/PEDF mRNA ratio, with ketamine alone increasing this ratio (F(1, 11) = 12.085, p = 0.005).
","['patients with depression', 'Twenty-five patients with depression', 'Patients were on psychotropic medication and continued treatment as usual throughout the study']","['ketamine and midazolam', 'ketamine', 'Ketamine', 'midazolam']","['time interaction for VEGFA/PEDF mRNA ratio', 'time interaction for VEGFA mRNA levels', 'depression scores (F(1,21)\xa0', 'PEDF levels', 'peripheral whole blood mRNA levels of vascular endothelial growth factor A (VEGFA) and PEDF, and the VEGFA/PEDF ratio', 'VEGFA levels', 'Blood plasma samples']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C3874456', 'cui_str': 'On psychotropic medication'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",25.0,0.0481452,"There was a significant group × time interaction for VEGFA/PEDF mRNA ratio, with ketamine alone increasing this ratio (F(1, 11) = 12.085, p = 0.005).
","[{'ForeName': 'Claire L', 'Initials': 'CL', 'LastName': 'McGrory', 'Affiliation': ""Trinity College Institute of Neuroscience, Trinity College Dublin, Dublin 2, Ireland; Department of Psychiatry, Trinity College Dublin, St Patrick's University Hospital, Dublin 8, Ireland.""}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Ryan', 'Affiliation': ""Trinity College Institute of Neuroscience, Trinity College Dublin, Dublin 2, Ireland; Department of Psychiatry, Trinity College Dublin, St Patrick's University Hospital, Dublin 8, Ireland.""}, {'ForeName': 'Bronagh', 'Initials': 'B', 'LastName': 'Gallagher', 'Affiliation': ""Department of Psychiatry, Trinity College Dublin, St Patrick's University Hospital, Dublin 8, Ireland.""}, {'ForeName': 'Declan M', 'Initials': 'DM', 'LastName': 'McLoughlin', 'Affiliation': ""Department of Psychiatry, Trinity College Dublin, St Patrick's University Hospital, Dublin 8, Ireland. Electronic address: d.mcloughlin@tcd.ie.""}]",Journal of affective disorders,['10.1016/j.jad.2020.04.013']
3014,32560938,Depression prevention in digital cognitive behavioral therapy for insomnia: Is rumination a mediator?,"Background There has been growing support for digital Cognitive Behavioral Therapy (dCBT-I) as a scalable intervention that both reduces insomnia and prevents depression. However, the mechanisms by which dCBT-I reduces and prevents depression is less clear. Methods This was a randomized controlled trial with two parallel arms: dCBT-I (N=358), or online sleep education as the control condition (N=300). Outcome variables were measured at pre-treatment, post-treatment, and one-year follow-up, and included the Insomnia Severity Index (ISI), the Quick Inventory of Depressive Symptomatology (QIDS-SR 16 ), and the Perseverative Thinking Questionnaire (PTQ). The analyses tested change in PTQ scores as a mediator for post-treatment insomnia, post-treatment depression, and incident depression at one-year follow-up. Results Reductions in rumination (PTQ) were significantly larger in the dCBT-I condition compared to control. Results also showed that reductions in rumination significantly mediated the improvement in post-treatment insomnia severity (proportional effect = 11%) and post-treatment depression severity (proportional effect = 19%) associated with the dCBT-I condition. Finally, reductions in rumination also significantly mediated the prevention of clinically significant depression via dCBT-I (proportional effect = 42%). Limitations Depression was measured with a validated self-report instrument instead of clinical interviews. Durability of results beyond one-year follow-up should also be tested in future research. Conclusions Results provide evidence that rumination is an important mechanism in how dCBT-I reduces and prevents depression.",2020,Results also showed that reductions in rumination significantly mediated the improvement in post-treatment insomnia severity (proportional effect = 11%) and post-treatment depression severity (proportional effect = 19%) associated with the dCBT-I condition.,['insomnia'],"['digital cognitive behavioral therapy', 'dCBT-I (N=358), or online sleep education']","['rumination (PTQ', 'rumination', 'PTQ scores', 'post-treatment insomnia severity', 'Insomnia Severity Index (ISI), the Quick Inventory of Depressive Symptomatology (QIDS-SR 16 ), and the Perseverative Thinking Questionnaire (PTQ', 'Limitations Depression']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.0526111,Results also showed that reductions in rumination significantly mediated the improvement in post-treatment insomnia severity (proportional effect = 11%) and post-treatment depression severity (proportional effect = 19%) associated with the dCBT-I condition.,"[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Cheng', 'Affiliation': 'Sleep Disorders and Research Center, Henry Ford Health System, 2779 West Grant Blvd, Detroit, MI, United States. Electronic address: pcheng1@hfhs.org.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kalmbach', 'Affiliation': 'Sleep Disorders and Research Center, Henry Ford Health System, 2779 West Grant Blvd, Detroit, MI, United States.'}, {'ForeName': 'Andrea Cuamatzi', 'Initials': 'AC', 'LastName': 'Castelan', 'Affiliation': 'Sleep Disorders and Research Center, Henry Ford Health System, 2779 West Grant Blvd, Detroit, MI, United States.'}, {'ForeName': 'Nimalan', 'Initials': 'N', 'LastName': 'Murugan', 'Affiliation': 'Sleep Disorders and Research Center, Henry Ford Health System, 2779 West Grant Blvd, Detroit, MI, United States.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Drake', 'Affiliation': 'Sleep Disorders and Research Center, Henry Ford Health System, 2779 West Grant Blvd, Detroit, MI, United States.'}]",Journal of affective disorders,['10.1016/j.jad.2020.03.184']
3015,32560956,Cognitive remediation for the treatment of neuropsychological disturbances in subjects with euthymic bipolar disorder: findings from a controlled study.,"INTRODUCTION


Individuals with euthymic Bipolar Disorder (BD) can experience deteriorated cognitive functioning, with such deterioration being associated with functional impairment. Cognitive remediation (CR) is considered an effective add-on intervention for neuropsychological impairments, but relatively few CR controlled studies have been performed on BD. In the present study the efficacy of a CR intervention designed for the improvement of cognition and functioning in patients with euthymic BD was tested.
METHODS


Patients (n = 54) with euthymic BD were assigned to receive active (n = 27) or control (n = 27) intervention. The active intervention (i.e. the Cognitive Remediation in Integrated Treatment - CRIIT - protocol) was made of 20 individual sessions focused on the treatment of attention, memory and executive functioning through the COGPACK software; each session was integrated with psychoeducation and rehabilitation interventions implemented through a metacognitive approach aimed at ameliorating personal agency.
RESULTS


A significant (p ≤ 0.015) time x group interaction at repeated measures MANOVA was observed on Rey Auditory Verbal Learning Test, Rey Complex Figure Test, Wisconsin Card Sorting Test, Trail Making Test, Visual Search, Life Skills Profile, and Barratt Impulsiveness Scale.
LIMITATIONS


A single-blind approach was used.
DISCUSSION


The results showed that patients undergoing active intervention improved in domains related to executive functions, attention, memory, functioning and impulsivity more significantly than patients undergoing control interventions. This study adds to the evidence that CR improves neurocognition in BD, and suggests that CRIIT protocol represents an add-on intervention of potential relevance to increase cognition and functioning in BD euthymic patients.",2020,"The results showed that patients undergoing active intervention improved in domains related to executive functions, attention, memory, functioning and impulsivity more significantly than patients undergoing control interventions.","['Individuals with euthymic Bipolar Disorder (BD', 'subjects with euthymic bipolar disorder', 'Patients (n\xa0', 'patients with euthymic BD']","['Cognitive remediation (CR', 'euthymic BD', 'Cognitive remediation', 'CR intervention']","['Rey Auditory Verbal Learning Test, Rey Complex Figure Test, Wisconsin Card Sorting Test, Trail Making Test, Visual Search, Life Skills Profile, and Barratt Impulsiveness Scale', 'executive functions, attention, memory, functioning and impulsivity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4505058', 'cui_str': 'Rey Auditory Verbal Learning Test'}, {'cui': 'C0589103', 'cui_str': 'Rey complex figure test'}, {'cui': 'C0451592', 'cui_str': 'Wisconsin card sorting test'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}]",54.0,0.0233267,"The results showed that patients undergoing active intervention improved in domains related to executive functions, attention, memory, functioning and impulsivity more significantly than patients undergoing control interventions.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bernabei', 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, Rome 00185, Italy; Department of Mental Health, ASL Roma 5, Colleferro, Rome, Italy. Electronic address: laura.bernabei@uniroma1.it.""}, {'ForeName': 'Francesco Saverio', 'Initials': 'FS', 'LastName': 'Bersani', 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, Rome 00185, Italy. Electronic address: francescosaverio.bersani@uniroma1.it.""}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Pompili', 'Affiliation': 'Department of Mental Health, ASL Roma 5, Colleferro, Rome, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Delle Chiaie', 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, Rome 00185, Italy.""}, {'ForeName': 'Donatella', 'Initials': 'D', 'LastName': 'Valente', 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, Rome 00185, Italy.""}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Corrado', 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, Rome 00185, Italy.""}, {'ForeName': 'Lucilla', 'Initials': 'L', 'LastName': 'Vergnani', 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, Rome 00185, Italy.""}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Ferracuti', 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, Rome 00185, Italy.""}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Biondi', 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, Rome 00185, Italy.""}, {'ForeName': 'Maria Antonietta', 'Initials': 'MA', 'LastName': ""Coccanari de'Fornari"", 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, Rome 00185, Italy.""}]",Journal of affective disorders,['10.1016/j.jad.2020.05.073']
3016,32561410,Computer-aided detection-assisted colonoscopy: classification and relevance of false positives.,"BACKGROUND AND AIMS


False-positive results (FPs) by computer-aided detection (CADe) hamper colonoscopy efficiency by uselessly extending examination time. Our aim was to develop a classification of the causes and clinical relevance of CADe FPs, and to assess the relative distribution of FPs in real-life setting.
METHODS


In a post-hoc analysis of a randomized trial comparing colonoscopy with and without CADe (NCT: 04079478), we extracted 40 CADe-colonoscopy videos. By modified Delphi process, 4 expert endoscopists identified the main domains for reasons and clinical relevance of FPs. Then, 2 expert endoscopists manually examined each FP activation, and classified it according to the proposed domains. Analysis was limited to the withdrawal phase.
RESULTS


The 2 main domains for the causes of CADe-FPs were identified as artifacts due to either mucosal wall or bowel content, whereas clinical relevance was defined by the time spent for FP and the FP rate per minute. Mean FPs per colonoscopy was 27.3 ± 13.1, of which 24 ± 12 (88%) and 3.2 ± 2.6 (12%) due to artifacts from bowel wall and bowel content, respectively. Of the 27.3 FP per colonoscopy, 1.6 (5.7%) required an additional exploration time of 4.8 ± 6.2 seconds per FP, ie, 0.7% of the mean withdrawal time (WT). In detail, 15 (24.2%), 33 (53.2%) and 14 (22.6%) FPs were classified as of mild, moderate, or severe clinical relevance. Rate of FP per minute of WT was 2.4 ± 1.2, being higher for FPs due to artifacts from bowel wall than for those from bowel content (2.4 ± 0.6 vs 0.3 ± 0.2, p < 0.001).
CONCLUSIONS


False positives by CADe are primarily due to artifacts from the bowel wall. Despite a high frequency, FPs result in a negligible 1% increase of the total withdrawal time as most of them are immediately discarded by the endoscopists.",2020,"Of the 27.3 FP per colonoscopy, 1.6 (5.7%) required an additional exploration time of 4.8 ± 6.2 seconds per FP, ie, 0.7% of the mean withdrawal time (WT).",[],"['colonoscopy with and without CADe (NCT', 'Computer-aided detection-assisted colonoscopy']","['mean withdrawal time (WT', 'Mean FPs per colonoscopy', 'Rate of FP per minute of WT', 'total withdrawal time', 'causes of CADe-FPs']",[],"[{'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",,0.0532188,"Of the 27.3 FP per colonoscopy, 1.6 (5.7%) required an additional exploration time of 4.8 ± 6.2 seconds per FP, ie, 0.7% of the mean withdrawal time (WT).","[{'ForeName': 'Cesare', 'Initials': 'C', 'LastName': 'Hassan', 'Affiliation': 'Digestive Endoscopy, Nuovo Regina Margherita Hospital, Rome, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Badalamenti', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Maselli', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan, Italy.'}, {'ForeName': 'Loredana', 'Initials': 'L', 'LastName': 'Correale', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Iannone', 'Affiliation': 'Section of Gastroenterology, Department of Emergency and Organ Transplantation, University of ""Aldo Moro"" of Bari, Bari, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Radaelli', 'Affiliation': 'Gastroenterology Department, Valduce Hospital, Como, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Rondonotti', 'Affiliation': 'Gastroenterology Department, Valduce Hospital, Como, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Ferrara', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Spadaccini', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan, Italy; Humanitas University, Department of Biomedical Sciences, Pieve Emanuele, Milan Italy.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Alkandari', 'Affiliation': 'Humanitas University, Department of Biomedical Sciences, Pieve Emanuele, Milan Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Fugazza', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Anderloni', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan, Italy.'}, {'ForeName': 'Piera Alessia', 'Initials': 'PA', 'LastName': 'Galtieri', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan, Italy.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Pellegatta', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Carrara', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan, Italy.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Di Leo', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Craviotto', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan, Italy; Humanitas University, Department of Biomedical Sciences, Pieve Emanuele, Milan Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lamonaca', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan, Italy; Humanitas University, Department of Biomedical Sciences, Pieve Emanuele, Milan Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Lorenzetti', 'Affiliation': 'Digestive Endoscopy, Nuovo Regina Margherita Hospital, Rome, Italy.'}, {'ForeName': 'Alida', 'Initials': 'A', 'LastName': 'Andrealli', 'Affiliation': 'Gastroenterology Department, Valduce Hospital, Como, Italy.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Antonelli', 'Affiliation': 'Digestive Endoscopy, Nuovo Regina Margherita Hospital, Rome, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wallace', 'Affiliation': 'Mayo Clinic, Jacksonville, USA.'}, {'ForeName': 'Prateek', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Kansas City Veterans Affairs Hospital, Kansas City, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rosch', 'Affiliation': 'Department of Interdisciplinary Endoscopy, University Hospital Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Repici', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan, Italy; Humanitas University, Department of Biomedical Sciences, Pieve Emanuele, Milan Italy. Electronic address: alessandro.repici@hunimed.eu.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.06.021']
3017,32561426,Recombinant human thrombopoietin in critically ill patients with sepsis-associated thrombocytopenia: A Clinical Study.,"BACKGROUND


Sepsis causes varying degrees of thrombocytopenia that are closely related to the likelihood of patient mortality. We analysed the effect of recombinant human thrombopoietin (rhTPO) on the platelet count in critically ill patients with sepsis-associated thrombocytopenia and provided a reference for its treatment.
MATERIAL/METHODS


The study was a retrospective analysis of the clinical data of patients. Patients were divided into an rhTPO group and control group according to the rhTPO use during treatment. Demographical and clinical data (age, sex, history of hypertension, diabetes, platelet counts, mortality rate et al.) of the patients were collected and analysed using statistical software; p<0.05 was considered statistically significant.
RESULTS


Of 213 patients, 84 patients constituted the rhTPO group and 129 constituted the control group. The increase in platelet counts was significantly higher in the rhTPO group than in the control group on the third day (43.01±18.23×10 9 /L vs 36.31±14.17×10 9 /L, p=0.003), fifth day (71.51±39.59×10 9 /L vs. 42.95±20.48×10 9 /L, p<0.001), and seventh day (115.36±69.41×10 9 /L vs. 62.54±42.70×10 9 /L, p<0.001). Further statistical analysis of the data of patients with platelet counts ≤30×10 9 /L and>30×10 9 /L and APACHE II scores>15 and ≤15 at the time of diagnosis showed that the increase in platelet counts in the rhTPO group was greater. There was no significant difference between the two groups in volume of platelet transfusions (rhTPO group 15.42±17.20 vs control group 10.93±17.48, p=0.068). The cost of ICU treatment in patients with rhTPO was higher (126,936.21±86,548.27 vs. 101,685.28±77,291.75 RMB, p=0.027); however, the ICU stay time was shorter (9.20±5.38 vs 10.88±6.82, p=0.047). There was no significant difference in 28-days mortality (rhTPO group: 25.0% vs control group: 34.1%, p=0.158) between the two groups.
CONCLUSION


For patients with severe thrombocytopenia or patients with severe sepsis, rhTPO is efficacious in increasing the patients' platelet counts, resulting in a shorter ICU stay time.",2020,The increase in platelet counts was significantly higher in the rhTPO group than in the control group on the third day (43.01±18.23×10 9,"['patients with severe thrombocytopenia or patients with severe sepsis', 'patients with platelet counts', 'critically ill patients with sepsis-associated thrombocytopenia and provided a reference for its treatment', '213 patients', '84 patients constituted the rhTPO group and 129 constituted the control group', 'critically ill patients with sepsis-associated thrombocytopenia', '≤30×10 9']","['recombinant human thrombopoietin (rhTPO', 'Recombinant human thrombopoietin', 'rhTPO']","['ICU stay time', 'platelet counts', 'volume of platelet transfusions', 'cost of ICU treatment', '28-days mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C1719672', 'cui_str': 'Severe Sepsis'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040052', 'cui_str': 'Thrombopoietin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040052', 'cui_str': 'Thrombopoietin'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0086818', 'cui_str': 'Platelet transfusion'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",213.0,0.0258731,The increase in platelet counts was significantly higher in the rhTPO group than in the control group on the third day (43.01±18.23×10 9,"[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Critical Care Medicine, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Jin', 'Affiliation': ""Emergency Department, Xi'an Aerospace General Hospital.""}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': ""Department of Critical Care Medicine, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Critical Care Medicine, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. Electronic address: sci2014@126.com.""}, {'ForeName': 'Litao', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': ""Department of Critical Care Medicine, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. Electronic address: glt2002@xjtu.edu.cn.""}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.06.045']
3018,32561466,A randomized clinical trial of a collaborative home-based diabetes intervention to reduce emergency department visits and hospitalizations in black individuals with diabetes.,"The prevalence of diabetes mellitus (DM) in black individuals (blacks) is twice that of white individuals (whites), and blacks are more likely to have worse glycemic control, less optimal medication regimens, and higher levels of mistrust in the medical system. These three factors account for higher rates of acute medical care use in blacks with DM. To address this disparity, we developed DM I-TEAM (Diabetes Interprofessional Team to Enhance Adherence to Medical Care), a home-based multidisciplinary behavioral intervention that integrates care from a community health worker (CHW), the participant's primary care physician (PCP), a DM nurse educator, and a clinical pharmacist. Treatment is delivered during 9 sessions over 1 year, and includes diabetes education and goal setting, telehealth visits with participants' PCP and a DM nurse educator, and comprehensive medication reviews by a pharmacist. We describe the rationale and methods for a randomized controlled trial to test the efficacy of DM I-TEAM to reduce emergency department (ED) visits and hospitalizations. We are enrolling 200 blacks with DM during an ED visit. Participants are randomized to DM I-TEAM or Usual Medical Care (UMC). Follow-up assessments are conducted at 6 and 12 months. The primary outcome is the number of ED visits and hospitalizations over 12 months, and is measured by participant self-report and medical record review. Secondary outcomes include hemoglobin A1c (HbA1c), number of potentially inappropriate medications (PIMs), and trust in health care.",2020,"The prevalence of diabetes mellitus (DM) in black individuals (blacks) is twice that of white individuals (whites), and blacks are more likely to have worse glycemic control, less optimal medication regimens, and higher levels of mistrust in the medical system.","['200 blacks with DM during an ED visit', 'blacks with DM', 'black individuals (blacks', 'black individuals with diabetes']","['DM I-TEAM', 'collaborative home-based diabetes intervention', 'DM I-TEAM or Usual Medical Care (UMC']","['hemoglobin A1c (HbA1c), number of potentially inappropriate medications (PIMs), and trust in health care', 'emergency department (ED) visits and hospitalizations', 'prevalence of diabetes mellitus (DM', 'number of ED visits and hospitalizations over 12\u202fmonths, and is measured by participant self-report and medical record review']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0730229', 'cui_str': 'Medical records review'}]",200.0,0.0803291,"The prevalence of diabetes mellitus (DM) in black individuals (blacks) is twice that of white individuals (whites), and blacks are more likely to have worse glycemic control, less optimal medication regimens, and higher levels of mistrust in the medical system.","[{'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Casten', 'Affiliation': 'Department of Psychiatry and Human Behavior, Sidney Kimmel Medical College at Thomas, Jefferson University, United States of America. Electronic address: Robin.Casten@Jefferson.edu.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Rovner', 'Affiliation': 'Departments of Neurology, Psychiatry, and Ophthalmology, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Anna Marie', 'Initials': 'AM', 'LastName': 'Chang', 'Affiliation': 'Department of Emergency Medicine, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Judd E', 'Initials': 'JE', 'LastName': 'Hollander', 'Affiliation': 'Department of Emergency Medicine, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Kelley', 'Affiliation': 'Department of Neurology, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Leiby', 'Affiliation': 'Division of Biostatistics, Department of Pharmacology and Experimental Therapeutics, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Ginah', 'Initials': 'G', 'LastName': 'Nightingale', 'Affiliation': 'Jefferson College of Pharmacy at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pizzi', 'Affiliation': 'Center for Health Outcomes, Policy, and Economics, Ernest Mario School of Pharmacy, Rutgers University, United States of America.'}, {'ForeName': 'Neva', 'Initials': 'N', 'LastName': 'White', 'Affiliation': 'Center for Urban Health, Thomas Jefferson University Hospital, United States of America.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Rising', 'Affiliation': 'Department of Emergency Medicine, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106069']
3019,32561467,A randomized comparison trial of culturally adapted HIV prevention approaches for Native Americans reducing trauma symptoms versus substance misuse: The Healing Seasons protocol.,"Native Americans (NA) experience interrelated risks of trauma exposure, substance use, and HIV risk behaviors that put them at increased risk for HIV infection. Despite these known risk factors, there are very few published randomized trials testing interventions to reduce trauma-related symptoms and substance misuse among NA.
METHODS


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


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


ClinicalTrials.gov number, NCT03112369, registered April 12, 2017.",2020,"Using a community-based participatory research approach, we adapted both evidence-based interventions to be specific to the risk contexts and realities of NA and to include psychoeducational and skill-building components that include cultural-specific stories, virtues, and traditional treatment strategies.","['Native Americans reducing trauma symptoms versus substance misuse', 'We stratified by age (16-29\u202fyears and 30 or older) and gender (male or female identified', 'Participants, 16\u202fyears and older, were recruited from a Pacific Northwest tribal community, screened over the phone, enrolled in person']","['NET or MIST', 'culturally adapted HIV prevention approaches', 'Narrative Exposure Therapy (NET) addressing PTSD or Motivational interviewing with cognitive behavioral therapy skills training (MIST', 'counseling-based HIV prevention intervention']","['number of sex partners and frequency of sexual acts (with and without condoms), sex under the influence of substances, frequency of substance use, and PTSD severity', 'HIV risk behaviors']","[{'cui': 'C0282204', 'cui_str': 'Native Americans'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030170', 'cui_str': 'Pacific Northwest'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0036911', 'cui_str': 'Sexual partners'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}]",,0.0757073,"Using a community-based participatory research approach, we adapted both evidence-based interventions to be specific to the risk contexts and realities of NA and to include psychoeducational and skill-building components that include cultural-specific stories, virtues, and traditional treatment strategies.","[{'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Pearson', 'Affiliation': 'Indigenous Wellness Research Institute, School of Social Work, University of Washington, Seattle, WA, USA. Electronic address: pearsonc@uw.edu.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kaysen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Huh', 'Affiliation': 'Indigenous Wellness Research Institute, School of Social Work, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bedard-Gillgan', 'Affiliation': 'Department of Psychiatry, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Walker', 'Affiliation': 'Innovative Programs Research Group, School of Social Work, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Marin', 'Affiliation': 'Indigenous Wellness Research Institute, School of Social Work, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Saluskin', 'Affiliation': 'Yakama Nation Behavioral Health Services, Toppenish, WA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106070']
3020,32443357,"A prospective observational study to explore the correlation of peripheral arterial pulse/resistance index, organ function, and inflammation in patients with septic shock.","INTRODUCTION


The evaluation of the functional status of blood vessels, especially the arterial system, plays a very important role in the judgment of the condition of septic shock patients and the guidance of resuscitation programs and the judgment of the therapeutic effect. We aimed to design an observational study protocol to explore the correlation of peripheral arterial pulse/resistance index, organ function and inflammation in patients with septic shock.
METHODS AND ANALYSIS


A total of 60 patients with septic shock in the Affiliated Hospital of Southwest Medical University from June 2020 to September 2020 and 20 healthy volunteers will be enrolled. Total of 60 patients with septic shock will be randomly divided into 20 groups by lot method. Group 1: fluid resuscitation; Group 2: fluid resuscitation + norepinephrine; Group 3: fluid resuscitation + norepinephrine + ulinastatin; Group 4: healthy control group. Fluid resuscitation is an early goal-directed fluid resuscitation in which norepinephrine is adjusted by a senior intensive care unit specialist for clinical presentation and ulinastatin is pumped at 20,000 U/h. Index including vascular ultrasound, inflammatory factors, organ function will be collected and analyzed.
DISCUSSION


Existing studies on septic shock focus on hemodynamics of the heart, brain, and kidney, while the differences in blood flow between peripheral blood vessels and protective renal vessels may be consistent, and imaging analysis is still lacking. This study protocol aims to explore the correlation of peripheral arterial pulsation index/resistance index, organ function, and inflammation in patients with septic shock.
TRIAL REGISTRATION


Chinese Clinical trial registry: ChiCTR2000031565.",2020,"The evaluation of the functional status of blood vessels, especially the arterial system, plays a very important role in the judgment of the condition of septic shock patients and the guidance of resuscitation programs and the judgment of the therapeutic effect.","['patients with septic shock', '60 patients with septic shock', '60 patients with septic shock in the Affiliated Hospital of Southwest Medical University from June 2020 to September 2020 and 20 healthy volunteers will be enrolled']","['Fluid resuscitation', 'fluid resuscitation; Group 2: fluid resuscitation\u200a+\u200anorepinephrine; Group 3: fluid resuscitation\u200a+\u200anorepinephrine\u200a+\u200aulinastatin; Group 4: healthy control group']","['peripheral arterial pulse/resistance index, organ function and inflammation', 'peripheral arterial pulse/resistance index, organ function, and inflammation', 'peripheral arterial pulsation index/resistance index, organ function, and inflammation', 'Index including vascular ultrasound, inflammatory factors, organ function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0077906', 'cui_str': 'urinastatin'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0232108', 'cui_str': 'Arterial pulse pressure'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0948543', 'cui_str': 'Vascular ultrasound'}]",60.0,0.138439,"The evaluation of the functional status of blood vessels, especially the arterial system, plays a very important role in the judgment of the condition of septic shock patients and the guidance of resuscitation programs and the judgment of the therapeutic effect.","[{'ForeName': 'Lirong', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': 'ICU, Affiliated Hospital of Southwest Medical University.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Leng', 'Affiliation': 'Department of General Surgery, Affiliated Hospital of Traditional Chinese Medicine, Southwest Medical University.'}, {'ForeName': 'Changxue', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'ICU, Affiliated Hospital of Southwest Medical University.'}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': 'Department of Critical Care, Luzhou Maternal and Child Health Hospital, Luzhou, Sichuan, China.'}]",Medicine,['10.1097/MD.0000000000020235']
3021,32443364,Home-based rehabilitation using smart wearable knee exercise device with electrical stimulation after anterior cruciate ligament reconstruction: A study protocol for a randomized controlled trial.,"INTRODUCTION


Rehabilitation after anterior cruciate ligament (ACL) reconstruction is critical to patient outcome. Despite its importance; however, hospital-based rehabilitation is limited, with barriers, including distance and cost. With recent technological advancements, wearable devices have actively been used to address these barriers. In this study, we propose a randomized controlled trial protocol investigating the efficacy and feasibility of home-based rehabilitation after ACL reconstruction using a smart wearable device providing electrical stimulation that allows knee exercise.
METHODS AND ANALYSIS


This is a protocol proposal for a prospective, single-center, randomized, controlled study. We plan to recruit adults discharged after ACL reconstruction; the recruited subjects will be randomly allocated to 1 of 2 groups, using a computer-generated randomization method: the intervention (n = 20) or control group (n = 20). The intervention group will receive a 6-week home-based rehabilitation program using smart wearable device. The control group will undergo a 6-week self-exercise program as normal. The following outcomes will be assessed at baseline, 2 weeks, and 6 weeks post the 6-week intervention program: quadriceps strength of the affect side as measured by a dynamometer (primary outcome); range of motion; root mean square of quadriceps muscle using surface electromyography; knee function using questionnaire; quality of life; subject's satisfaction score using questionnaire; frequency and duration of exercise; and knee pain. An intention-to-treat analysis will be conducted for the primary outcome.
DISCUSSION


This study is a prospective, single-center, randomized, controlled study. This study aims to research the feasibility and efficacy of a 6-week, structured home-based rehabilitation program for patients after ACL reconstruction using a smart wearable device. The findings of this study will help to establish a home-based rehabilitation program to better recovery in patients with ACL reconstruction.
TRIAL REGISTRATION NUMBER


This protocol was registered in ClinicalTrials.gov, under the number NCT04079205.",2020,"This study aims to research the feasibility and efficacy of a 6-week, structured home-based rehabilitation program for patients after ACL reconstruction using a smart wearable device.","['patients after ACL reconstruction using a smart wearable device', 'adults discharged after ACL reconstruction; the recruited subjects', 'anterior cruciate ligament reconstruction', 'patients with ACL reconstruction']","['home-based rehabilitation after ACL reconstruction', '6-week self-exercise program', '6-week home-based rehabilitation program using smart wearable device', 'Rehabilitation after anterior cruciate ligament (ACL) reconstruction', 'Home-based rehabilitation using smart wearable knee exercise device with electrical stimulation', 'structured home-based rehabilitation program']","[""quadriceps strength of the affect side as measured by a dynamometer (primary outcome); range of motion; root mean square of quadriceps muscle using surface electromyography; knee function using questionnaire; quality of life; subject's satisfaction score using questionnaire; frequency and duration of exercise; and knee pain""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C4505348', 'cui_str': 'Wearable Technology'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C4505348', 'cui_str': 'Wearable Technology'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0454364', 'cui_str': 'Knee exercises'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}]",,0.103089,"This study aims to research the feasibility and efficacy of a 6-week, structured home-based rehabilitation program for patients after ACL reconstruction using a smart wearable device.","[{'ForeName': 'Gowun', 'Initials': 'G', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam-si.'}, {'ForeName': 'Won-Seok', 'Initials': 'WS', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam-si.'}, {'ForeName': 'Tae Woo', 'Initials': 'TW', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopedic Surgery, Seoul National University College of Medicine, SMG-SNU Boramae Medical Center, Seoul.'}, {'ForeName': 'Yong Seuk', 'Initials': 'YS', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University College of Medicine, Seoul National University Bundang Hospital.'}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'EXOSYSTEMS Inc., Seongnam-si, Republic of Korea.'}, {'ForeName': 'Nam-Jong', 'Initials': 'NJ', 'LastName': 'Paik', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam-si.'}]",Medicine,['10.1097/MD.0000000000020256']
3022,32443379,An investigation into the impact of enteric coated of aspirin in patients with newly diagnosed ischemic stroke (ECASIS).,"INTRODUCTION


Uncertainty remains regarding the impact of enteric-coated (EC) aspirin as it relates to the reduction of cardiovascular risk. We hypothesize that EC formulation based on a previous report may blunt aspirin response as evidenced by reduced Thromboxane A2 (TXA 2) levels in diabetic patients. Thus, it was imperative to ascertain and validate the effect of the EC formulation of Aspirin on the Thromboxane B2 (TXB2) level.
METHODS/DESIGN


An open-label consecutive randomized interventional controlled trial. Patients with newly diagnosed ischemic stroke who are just about to start Aspirin were assessed for eligibility and inclusion in our trial. Consecutive patients (admitted to the stroke unit of Hamad General Hospital, Hamad Medical Corporation, Doha, Qatar) will be randomized to receive either EC aspirin or plain Aspirin. They will be required to continue taking them throughout the study (3 days). Demographics and laboratory records of the study participants will be abstracted from online records. Further study variables will be obtained manually in designated case record forms (CRF). The primary outcomes are the incidence of aspirin non-responders (level of residual serum TXB2 associated with elevated thrombotic risk (<99.0% inhibition or TXB2 >3.1 ng/mL) within 72 h after three daily aspirin doses). Whereas secondary outcomes are the incidence of GIT bleeding of various preparations of Aspirin. The study was approved by MRC and IRB of Hamad Medical Corporation (MRC number: 01-18-156).
DISCUSSION


This trial will determine potential differences in the efficacy of EC Aspirin and plain Aspirin on the Thromboxane B2 level. Additionally, it will ascertain the tolerability and safety of both formulations of Aspirin in patients with newly diagnosed ischemic stroke. These results will either support the current notion of no difference between the two formulations. However, if a difference is found, this will invite for future trials exploring clinical outcomes occurrence between various formulations.
CLINICAL TRIAL REGISTRATION


Clinicaltrials.gov NCT04330872 registered on April 2, 2020.",2020,TXB2 associated with elevated thrombotic risk (<99.0% inhibition or TXB2 >3.1 ng/mL) within 72 h after three daily aspirin doses).,"['patients with newly diagnosed ischemic stroke (ECASIS', 'Patients with newly diagnosed ischemic stroke who are just about to start', 'Consecutive patients (admitted to the stroke unit of Hamad General Hospital, Hamad Medical Corporation, Doha, Qatar', 'diabetic patients', 'patients with newly diagnosed ischemic stroke']","['enteric-coated (EC) aspirin', 'TXB2', 'Aspirin', 'aspirin', 'EC aspirin or plain Aspirin', 'EC Aspirin and plain Aspirin']","['Thromboxane A2 (TXA 2) levels', 'Thromboxane B2 (TXB2) level', 'incidence of aspirin non-responders (level of residual serum', 'elevated thrombotic risk', 'incidence of GIT bleeding of various preparations of Aspirin', 'Thromboxane B2 level', 'tolerability and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0587502', 'cui_str': 'Stroke unit'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0034366', 'cui_str': 'Qatar'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0040059', 'cui_str': 'Thromboxane B>2<'}, {'cui': 'C0453946', 'cui_str': 'Coat'}]","[{'cui': 'C0040057', 'cui_str': 'Thromboxane A>2<'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040059', 'cui_str': 'Thromboxane B>2<'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.103097,TXB2 associated with elevated thrombotic risk (<99.0% inhibition or TXB2 >3.1 ng/mL) within 72 h after three daily aspirin doses).,"[{'ForeName': 'Mohamed Nabil', 'Initials': 'MN', 'LastName': 'Elshafei', 'Affiliation': 'Clinical Pharmacy Department.'}, {'ForeName': 'Yahia', 'Initials': 'Y', 'LastName': 'Imam', 'Affiliation': 'Neurology Department, Hamad General Hospital, Hamad Medical Corporation.'}, {'ForeName': 'Mouhand F H', 'Initials': 'MFH', 'LastName': 'Mohamed', 'Affiliation': 'Internal Medicine Department, Hamad General Hospital.'}, {'ForeName': 'Arwa Ebrahim', 'Initials': 'AE', 'LastName': 'AlSaud', 'Affiliation': 'Internal Medicine Department, Hamad General Hospital.'}, {'ForeName': 'Mohamed Sayed', 'Initials': 'MS', 'LastName': 'Ahmed', 'Affiliation': 'Neurology Department, Hamad General Hospital, Hamad Medical Corporation.'}, {'ForeName': 'Khaldun', 'Initials': 'K', 'LastName': 'Obeidat', 'Affiliation': 'Internal Medicine Department, Hamad General Hospital.'}, {'ForeName': 'Razan', 'Initials': 'R', 'LastName': 'Saeid', 'Affiliation': 'Internal Medicine Department, Hamad General Hospital.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Ali', 'Affiliation': 'Internal Medicine Department, Hamad General Hospital.'}, {'ForeName': 'Ibtihal M', 'Initials': 'IM', 'LastName': 'Abdallah', 'Affiliation': 'Clinical Pharmacy Department.'}, {'ForeName': 'Aeijaz Sultan', 'Initials': 'AS', 'LastName': 'Parray', 'Affiliation': 'Interim-Lab, Hamad Medical City, Hamad Medical Corporation.'}, {'ForeName': 'Mohammed Ibn-Masoud', 'Initials': 'MI', 'LastName': 'Danjuma', 'Affiliation': 'Internal Medicine Department, Hamad General Hospital.'}]",Medicine,['10.1097/MD.0000000000020307']
3023,32443390,Effects of virtual reality immersive training with computerized cognitive training on cognitive function and activities of daily living performance in patients with acute stage stroke: A preliminary randomized controlled trial: Retraction.,,2020,,['patients with acute stage stroke'],['virtual reality immersive training with computerized cognitive training'],['cognitive function and activities of daily living performance'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",,0.160731,,[],Medicine,['10.1097/MD.0000000000020598']
3024,32443963,Perceptive-Cognitive and Physical Function in Prefrail Older Adults: Exergaming Versus Traditional Multicomponent Training.,"Research highlights the benefits of regular traditional multicomponent training in older adults. The potential effect of exergames on perceptive-cognitive and physical function in prefrail older adults is still little explored. The study aimed to compare the effects of two physical exercise training programs (exergaming vs. traditional multicomponent) on perceptive-cognitive and physical functions of prefrail older adults. This study was a randomized controlled trial having 66 prefrail older adults assigned to two groups (exergame group [EG]:  n  = 32, 70.84 ± 4.53 years; multicomponent group [MG]:  n  = 34, 70.76 ± 5.60 years). Frailty phenotype, fall history, basic and advanced cognition, perceptual, physical (mobility, gait speed, and balance), and muscle (strength and power) functions were evaluated. Intervention was conducted during 12 weeks. The EG and MG performed similar exercise routines involving the main lower limb muscle groups required in daily activities. A mixed model analysis of variance (ANOVA) and effect size ( d ) revealed that both programs were effective in postponing frailty status, reducing the fear of falling (EG:  d  = 1.65; MG:  d  = 1.40), increasing fall risk awareness (EG:  d  = 2.14; MG:  d  = 1.60), improving cognitive status (EG:  d  = 0.83-2.61; MG:  d  = 0.86-1.43), muscle (EG:  d  = 0.54; MG:  d  = 0.51-0.73), and physical function (EG:  d  = 0.97-1.55; MG:  d  = 1.01-2.23). The exergame training might be a better alternative to improve cognition, whereas the multicomponent program may be a better option to provide physical function gains.",2020,"A mixed model ANOVA and effect size (d) revealed that both programs were effective in postponing frailty status, reducing the fear of falling (EG: d=1.65; MG: d=1.40), increasing fall risk awareness (EG: d=2.14; MG: d=1.60), improving cognitive status","['older adults', '66 pre-frail older adults assigned to two groups (Exergames [EG]: n = 32, 70.84 ± 4.53 years', 'pre-frail older adults']","['regular traditional multicomponent training', 'Multicomponent [MG', 'traditional multicomponent training', 'physical exercise training programs (exergaming vs. traditional multicomponent']","['Perceptive-cognitive and physical function', 'fall risk awareness', 'perceptive-cognitive and physical function', 'Frailty phenotype, fall history, basic and advanced cognition, perceptual, physical (mobility, gait speed, and balance) and muscle (strength and power) functions', 'cognitive status', 'perceptive-cognitive and physical functions']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0079379', 'cui_str': 'Frail Older Adults'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",66.0,0.011829,"A mixed model ANOVA and effect size (d) revealed that both programs were effective in postponing frailty status, reducing the fear of falling (EG: d=1.65; MG: d=1.40), increasing fall risk awareness (EG: d=2.14; MG: d=1.60), improving cognitive status","[{'ForeName': 'Natália Boneti', 'Initials': 'NB', 'LastName': 'Moreira', 'Affiliation': 'Prevention and Rehabilitation in Physiotherapy Department, Federal University of Paraná, Curitiba, Paraná, Brazil.'}, {'ForeName': 'André L F', 'Initials': 'ALF', 'LastName': 'Rodacki', 'Affiliation': 'Physical Education Masters and PhD Programs, Federal University of Paraná, Curitiba, Parana, Brazil.'}, {'ForeName': 'Sabrine N', 'Initials': 'SN', 'LastName': 'Costa', 'Affiliation': 'Physical Education Masters and PhD Programs, Federal University of Paraná, Curitiba, Parana, Brazil.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Pitta', 'Affiliation': 'Physical Education Masters and PhD Programs, Federal University of Paraná, Curitiba, Parana, Brazil.'}, {'ForeName': 'Paulo C B', 'Initials': 'PCB', 'LastName': 'Bento', 'Affiliation': 'Physical Education Masters and PhD Programs, Federal University of Paraná, Curitiba, Parana, Brazil.'}]",Rejuvenation research,['10.1089/rej.2020.2302']
3025,32560744,"AGILE-ACCORD: A Randomized, Multicentre, Seamless, Adaptive Phase I/II Platform Study to Determine the Optimal Dose, Safety and Efficacy of Multiple Candidate Agents for the Treatment of COVID-19: A structured summary of a study protocol for a randomised platform trial.","OBJECTIVES


Phase I - To determine the optimal dose of each candidate (or combination of candidates) entered into the platform. Phase II - To determine the efficacy and safety of each candidate entered into the platform, compared to the current Standard of Care (SoC), and recommend whether it should be evaluated further in a later phase II & III platforms.
TRIAL DESIGN


AGILE-ACCORD is a Bayesian multicentre, multi-arm, multi-dose, multi-stage open-label, adaptive, seamless phase I/II randomised platform trial to determine the optimal dose, activity and safety of multiple candidate agents for the treatment of COVID-19. Designed as a master protocol with each candidate being evaluated within its own sub-protocol (Candidate Specific Trial (CST) protocol), randomising between candidate and SoC with 2:1 allocation in favour of the candidate (N.B the first candidate has gone through regulatory approval and is expected to open to recruitment early summer 2020). Each dose will be assessed for safety sequentially in cohorts of 6 patients. Once a phase II dose has been identified we will assess efficacy by seamlessly expanding into a larger cohort.
PARTICIPANTS


Patient populations can vary between CSTs, but the main eligibility criteria include adult patients (≥18 years) who have laboratory-confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We will include both severe and mild-moderate patients defined as follows: Group A (severe disease) - patients with WHO Working Group on the Clinical Characteristics of COVID-19 infection 9-point ordinal scale of Grades 4 (hospitalised, oxygen by mask or nasal prongs), 5 (hospitalised, non-invasive ventilation or high flow oxygen), 6 (hospitalised, intubation and mechanical ventilation) or 7 (hospitalised, ventilation and additional organ support); Group B (mild-moderate disease) - ambulant or hospitalised patients with peripheral capillary oxygen saturation (SpO 2 ) >94% RA. If any CSTs are included in the community setting, the CST protocol will clarify whether patients with suspected SARS-CoV-2 infection are also eligible. Participants will be recruited from England, North Ireland, Wales and Scotland.
INTERVENTION AND COMPARATOR


Comparator is the current standard of care (SoC), in some CSTs plus placebo. Candidates that prevent uncontrolled cytokine release, prevention of viral replication, and other anti-viral treatment strategies are at various stages of development for inclusion into AGILE-ACCORD. Other CSTs will be added over time. There is not a set limit on the number of CSTs we can include within the AGILE-ACCORD Master protocol and we will upload each CST into this publication as each opens to recruitment.
MAIN OUTCOMES


Phase I: Dose limiting toxicities using Common Terminology Criteria for Adverse Events v5 Grade ≥3 adverse events. Phase II: Agreed on a CST basis depending on mechanism of action of the candidate and patient population. But may include; time to clinical improvement of at least 2 points on the WHO 9-point category ordinal scale [measured up to 29 days from randomisation], progression of disease (oxygen saturation (SaO 2)  <92%) or hospitalization or death, or change in time-weighted viral load [measured up to 29 days from randomisation].
RANDOMISATION


Varies with CST, but default is 2:1 allocation in favour of the candidate to maximise early safety data.
BLINDING (MASKING)


For the safety phase open-label although for some CSTs may include placebo or SoC for the efficacy phase.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


Varies between CSTs. However simulations have shown that around 16 participants are necessary to determine futility or promise of a candidate at a given dose (in efficacy evaluation alone) and between 32 and 40 participants are required across the dose-finding and efficacy evaluation when capping the maximum number of participants contributing to the evaluation of a treatment at 40.
TRIAL STATUS


Master protocol version number v5 07 May 2020, trial is in setup with full regulatory approval and utilises several digital technology solutions, including Medidata's Rave EDC [electronic data capture], RTSM for randomisation and patient eConsent on iPads via Rave Patient Cloud. The recruitment dates will vary between CSTs but at the time of writing no CSTs are yet open for recruitment.
TRIAL REGISTRATION


EudraCT 2020-001860-27 14 th  March 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"However simulations have shown that around 16 participants are necessary to determine futility or promise of a candidate at a given dose (in efficacy evaluation alone) and between 32 and 40 participants are required across the dose-finding and efficacy evaluation when capping the maximum number of participants contributing to the evaluation of a treatment at 40.
","['27 14 th  March 2020', 'Participants will be recruited from England, North Ireland, Wales and Scotland', 'Patient populations can vary between CSTs, but the main eligibility criteria include adult patients (≥18 years) who have laboratory-confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2', 'severe and mild-moderate patients defined as follows: Group A (severe disease) - patients with WHO Working Group on the Clinical Characteristics of COVID-19 infection 9-point ordinal scale of Grades 4 (hospitalised, oxygen by mask or nasal prongs), 5 (hospitalised, non-invasive ventilation or high flow oxygen), 6 (hospitalised, intubation and mechanical ventilation) or 7 (hospitalised, ventilation and additional organ support); Group B (mild-moderate disease) - ambulant or hospitalised patients with peripheral capillary oxygen saturation (SpO 2 ) >94% RA', 'COVID-19', '2020-001860']","['EudraCT', 'placebo']","['WHO 9-point category ordinal scale', 'efficacy and safety', 'progression of disease (oxygen saturation (SaO 2)  <92%) or hospitalization or death, or change in time-weighted viral load']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0560172', 'cui_str': 'cSt'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0445087', 'cui_str': 'Nasal prongs'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0428178', 'cui_str': 'Capillary oxygen saturation measurement'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C1862322', 'cui_str': 'Southeast Asian ovalocytosis'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}]",,0.176754,"However simulations have shown that around 16 participants are necessary to determine futility or promise of a candidate at a given dose (in efficacy evaluation alone) and between 32 and 40 participants are required across the dose-finding and efficacy evaluation when capping the maximum number of participants contributing to the evaluation of a treatment at 40.
","[{'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Griffiths', 'Affiliation': 'University of Southampton, Southampton, Hampshire, UK. G.O.Griffiths@soton.ac.uk.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Fitzgerald', 'Affiliation': 'Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jaki', 'Affiliation': 'Lancaster University and University of Cambridge, Lancaster, Lancashire, UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Corkhill', 'Affiliation': 'Southampton CTU, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Ellice', 'Initials': 'E', 'LastName': 'Marwood', 'Affiliation': 'Southampton CTU, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Reynolds', 'Affiliation': 'University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Stanton', 'Affiliation': 'Southampton CTU, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Ewings', 'Affiliation': 'Southampton CTU, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Susannah', 'Initials': 'S', 'LastName': 'Condie', 'Affiliation': 'Southampton CTU, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Wrixon', 'Affiliation': 'Southampton CTU, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Norton', 'Affiliation': 'Medidata Solutions, London, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Radford', 'Affiliation': 'Southampton CTU, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Yeats', 'Affiliation': 'Southampton CTU, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Robertson', 'Affiliation': 'Southampton CTU, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Darby-Dowman', 'Affiliation': 'Cancer Research UK Centre for Drug Development, London, UK.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Walker', 'Affiliation': 'University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Saye', 'Initials': 'S', 'LastName': 'Khoo', 'Affiliation': 'University of Liverpool, Liverpool, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04473-1']
3026,32560970,Development of children born from freeze-only versus fresh embryo transfer: follow-up of a randomized controlled trial.,"OBJECTIVE


To compare the longer-term development outcomes in children born after freeze-only versus fresh embryo transfer (ET) in women with an ovulatory cycle.
DESIGN


Long-term follow-up study (NCT04099784) of babies born alive after the first ET in a randomized controlled trial (RCT) comparing ongoing pregnancy and live birth rates after use of a freeze-only versus fresh ET strategy (NCT02471573).
SETTING


Private clinic.
PATIENT(S)


Of 391 couples randomized to each treatment group in the RCT, 132 (97 singleton/35 twins) and 123 (95 singleton/28 twins) in the freeze-only and fresh ET groups had live birth; 113 parents (86%) from the freeze-only group (147 babies) and 99 (80%) from the fresh ET group (120 babies) returned questionnaires for this follow-up study.
INTERVENTION(S)


Use of a freeze-only or fresh ET strategy after controlled ovarian hyperstimulation with a follicle-stimulating hormone/gonadotropin-releasing antagonist protocol.
MAIN OUTCOME MEASURE(S)


Developmental status at ≥2 years after birth, determined using the Developmental Red Flags and Ages & Stages Third Edition (ASQ-3) Questionnaires.
RESULT(S)


Mean age of children at the end of follow-up was 37 months. Height (95.0 ± 6.1 vs. 95.7 ± 5.6 cm) and weight (14.9 ± 2.6 vs. 14.8 ± 2.6 kg) were similar in the freeze-only and fresh ET groups (results were similar when singletons and twins were analyzed separately). Overall, ASQ-3 scores for problem solving were significantly better in the freeze-only versus fresh ET group (overall: 53.6 ± 8.4 vs. 51.1 ± 10.2), with no significant between-group difference when singletons (52.3 ± 10.1 vs. 51.0 ± 9.9) and twins (55.0 ± 5.5 vs. 51.4 ± 11.1) were analyzed separately. Fine motor skills scores were numerically higher (with P values approaching statistical significance) in the freeze-only versus fresh ET group in the overall analysis (47.8 ± 11.6 vs. 44.9 ± 12.6) and twins (49.85 ± 8.72 vs. 43.93 ± 12.71), but not singletons (46.0 ± 13.4 vs. 45.4 ± 12.6). The overall proportion of children with abnormal ASQ-3 (6.8% vs. 8.3%) or abnormal Red Flags (5.4% vs. 6.7%) findings in the freeze-only and fresh ET groups was low and did not differ significantly between groups.
CONCLUSION(S)


These data provide physicians with additional information on which to base decisions about the relative merits of different approaches to infertility treatment. There do not appear to be any grounds for concern about worse outcomes after use of a freeze-only strategy. However, additional studies comparing childhood development after a freeze-only strategy, fresh ET, and natural cycles are needed before firm conclusions can be drawn.",2020,"Fine motor skills scores were numerically higher (with P values approaching statistical significance) in the freeze-only versus fresh ET group in the overall analysis (47.8 ± 11.6 vs. 44.9 ± 12.6) and twins (49.85 ± 8.72 vs. 43.93 ± 12.71), but not singletons (46.0 ± 13.4 vs. 45.4 ± 12.6).","['children born after', 'women with an ovulatory cycle', 'children born from', '132 (97 singleton/35 twins) and 123 (95 singleton/28 twins) in the freeze-only and fresh ET groups had live birth; 113 parents (86%) from the freeze-only group (147 babies) and 99 (80%) from the fresh ET group (120 babies) returned questionnaires for this follow-up study', '391 couples randomized to each treatment group in the RCT', 'Private clinic', 'babies born alive after the first ET']","['freeze-only or fresh ET strategy', 'freeze-only versus fresh embryo transfer (ET', 'freeze-only versus fresh embryo transfer']","['Developmental Red Flags and Ages & Stages Third Edition (ASQ-3) Questionnaires', 'Fine motor skills scores', 'overall proportion of children with abnormal ASQ-3', 'abnormal Red Flags', 'Overall, ASQ-3 scores for problem solving']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory'}, {'cui': 'C0041427', 'cui_str': 'Twin sibling'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0440732', 'cui_str': 'Fresh embryo'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}]","[{'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0440732', 'cui_str': 'Fresh embryo'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}]","[{'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C5200790', 'cui_str': 'Flags'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0441796', 'cui_str': 'Third edition'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}]",391.0,0.0738169,"Fine motor skills scores were numerically higher (with P values approaching statistical significance) in the freeze-only versus fresh ET group in the overall analysis (47.8 ± 11.6 vs. 44.9 ± 12.6) and twins (49.85 ± 8.72 vs. 43.93 ± 12.71), but not singletons (46.0 ± 13.4 vs. 45.4 ± 12.6).","[{'ForeName': 'Lan Ngoc', 'Initials': 'LN', 'LastName': 'Vuong', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam; IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam; HOPE Research Center, My Duc Hospital, Ho Chi Minh City, Vietnam. Electronic address: lanvuong@ump.edu.vn.'}, {'ForeName': 'Trung Thien', 'Initials': 'TT', 'LastName': 'Ly', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nghia An', 'Initials': 'NA', 'LastName': 'Nguyen', 'Affiliation': 'Department of Pediatrics, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Loc Minh Tai', 'Initials': 'LMT', 'LastName': 'Nguyen', 'Affiliation': 'HOPE Research Center, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Xuyen Thi Ha', 'Initials': 'XTH', 'LastName': 'Le', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Tien Khac', 'Initials': 'TK', 'LastName': 'Le', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Khanh Tuan Quoc', 'Initials': 'KTQ', 'LastName': 'Le', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Thanh Van', 'Initials': 'TV', 'LastName': 'Le', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Minh Hoang Nhat', 'Initials': 'MHN', 'LastName': 'Nguyen', 'Affiliation': 'HOPE Research Center, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Vinh Quang', 'Initials': 'VQ', 'LastName': 'Dang', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam; HOPE Research Center, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Norman', 'Affiliation': 'Robinson Research Institute and Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia; Fertility SA, Adelaide, South Australia, Australia.'}, {'ForeName': 'Ben Willem', 'Initials': 'BW', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, School of Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Tuong Manh', 'Initials': 'TM', 'LastName': 'Ho', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam; HOPE Research Center, My Duc Hospital, Ho Chi Minh City, Vietnam.'}]",Fertility and sterility,['10.1016/j.fertnstert.2020.04.041']
3027,32561087,CD133 + cell infusion in patients with colorectal liver metastases going to be submitted to a major liver resection (CELLCOL): A randomized open label clinical trial.,"BACKGROUND


Treatment of liver metastases of colorectal carcinoma is surgical resection. However, only 10-15% of the patients in this context will be candidate for curative resection arising other 10-13% after response to neoadyuvant chemotherapy. In order to perform the liver metastases surgery, it is necessary to have a sufficient remnant liver volume (RLV) which allows maintaining an optimal liver function after resection. Studies on liver regeneration have determined that CD133 + stem cells are involved in liver hypertrophy developed after an hepatectomy with encouraging results. As presented in previous studies, CD133 + stem cells can be selected from peripheral blood after stimulation with G-CSF, being able to obtain a large number of them. We propose to treat patients who do not meet criteria for liver metastases surgery because of insufficient RLV (<40%) with CD133 + cells together with portal embolization, in order to achieve enough liver volume which avoids liver failure.
METHODS


/Design: The aim of this study is to evaluate the effectiveness of preoperative PVE plus the administration of CD133 + mobilized from peripheral blood with G-CSF compared to PVE only. SECONDARY AIMS ARE: to compare the grade of hypertrophy, speed and changes in liver function, anatomopathological study of hypertrophied liver, to determine the safety of the treatment and analysis of postoperative morbidity and surveillance.
STUDY DESIGN


Prospective randomized longitudinal phase IIb clinical trial, open, to evaluate the efficacy of portal embolization (PVE) together with the administration of CD133 + cells obtained from peripheral blood versus PVE alone, in patients with hepatic metastasis of colorectal carcinoma (CCRHM).
DISCUSSION


The number of CD133 + obtained from peripheral blood after G -CSF stimulation will be far greater than the number obtained with direct puncture of bone marrow. This will allow a greater intrahepatic infusion, which could have a direct impact on achieving a larger and quicker hypertrophy. Consequently, it will permit the treatment of a larger number of patients with an increase on their survival.
TRIAL REGISTRATION


ClinicalTrials.gov, ID NCT03803241.",2020,"STUDY DESIGN


Prospective randomized longitudinal phase IIb clinical trial, open, to evaluate the efficacy of portal embolization (PVE) together with the administration of CD133 + cells obtained from peripheral blood versus PVE alone, in patients with hepatic metastasis of colorectal carcinoma (CCRHM).
","['patients with hepatic metastasis of colorectal carcinoma (CCRHM', 'patients who do not meet criteria for liver metastases surgery because of insufficient RLV (<40%) with CD133\xa0+\xa0cells together with portal embolization, in order to achieve enough liver volume which avoids liver failure', 'Design', 'patients with colorectal liver metastases going to be submitted to a major liver resection (CELLCOL']","['CD133 + cell infusion', 'portal embolization (PVE', 'CD133\xa0+\xa0cells obtained from peripheral blood versus PVE alone']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0085605', 'cui_str': 'Hepatic failure'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}]","[{'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}]",[],,0.0500979,"STUDY DESIGN


Prospective randomized longitudinal phase IIb clinical trial, open, to evaluate the efficacy of portal embolization (PVE) together with the administration of CD133 + cells obtained from peripheral blood versus PVE alone, in patients with hepatic metastasis of colorectal carcinoma (CCRHM).
","[{'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Garcia-Botella', 'Affiliation': 'Surgery (HepatoPancreatoBiliary Unit), Hospital Clínico San Carlos Madrid, Spain. Electronic address: sandragbotella@gmail.com.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Sáez-Carlin', 'Affiliation': 'Surgery (HepatoPancreatoBiliary Unit), Hospital Clínico San Carlos Madrid, Spain. Electronic address: psaezcarlin@gmail.com.'}, {'ForeName': 'Ramiro', 'Initials': 'R', 'LastName': 'Méndez', 'Affiliation': 'Department of Radiology, Hospital Universitario Clínico San Carlos, Madrid, Spain. Electronic address: ramiro.mendez@outlook.com.'}, {'ForeName': 'Maria Paz', 'Initials': 'MP', 'LastName': 'Martin', 'Affiliation': 'Department o Hematology, Hospital Universitario Clínico San Carlos, Madrid, Spain. Electronic address: mariapazmartin@gmail.com.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Ortega', 'Affiliation': 'Department of Surgical Pathology, Hospital Clínico San Carlos, Madrid, Spain. Electronic address: luis.ortega@salud.madrid.org.'}, {'ForeName': 'Jose Vicente', 'Initials': 'JV', 'LastName': 'Méndez', 'Affiliation': 'Department of Radiology, Hospital Universitario Clínico San Carlos, Madrid, Spain. Electronic address: jvmendezmontero@hotmail.com.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'García-Paredes', 'Affiliation': 'Department of Oncology, Hospital Universitario Clínico San Carlos, Madrid, Spain. Electronic address: begarpa@hotmail.com.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Diez-Valladares', 'Affiliation': 'Surgery (HepatoPancreatoBiliary Unit), Hospital Clínico San Carlos Madrid, Spain. Electronic address: lidiez@hotmail.com.'}, {'ForeName': 'Antonio Jose', 'Initials': 'AJ', 'LastName': 'Torres', 'Affiliation': 'Surgery (HepatoPancreatoBiliary Unit), Hospital Clínico San Carlos Madrid, Spain. Electronic address: antoniojose.torres@salud.madrid.org.'}]",Surgical oncology,['10.1016/j.suronc.2019.10.005']
3028,32561260,Quantitative Analysis of Patellar Tendon After Total Knee Arthroplasty Using Echo Intensity: A Nonrandomized Controlled Trial of Alpine Skiing.,"BACKGROUND


Despite the knee extensor weakness, less attention has been paid to the evaluation of patellar tendon after total knee arthroplasty (TKA). We previously observed patellar tendon hypertrophy after TKA. The purpose of this study is to reanalyze these ultrasound data to detect whether brightness mode ultrasound imaging reflects pathological changes of the patellar tendon after TKA.
METHODS


Twenty-eight participants with post unilateral TKA were assigned to an intervention group or control group. The intervention group underwent a 12-week skiing program. Patellar tendon mechanical properties were obtained by combining isometric dynamometry, ultrasound imaging, and electromyography in operated knee and nonoperated knee. Luminosity ratio (LR) was measured using echo intensity in a relaxed and maximally loaded phase.
RESULTS


Baseline comparisons revealed significant effects of the surgical side (P < .001) and loading phase (P = .017), but no interaction between leg and phase (P < .149). LR of the operated knee was significantly lower than LR of the nonoperated knee in relaxed (P < .001) and maximally loaded phases (P = .003). In addition, there was a significant correlation between LR of maximum phase and isometric knee extension torque (r 2  = 0.156, P = .038). However, LR was not related to patellar tendon stiffness, Young's modulus, or strain. There was a significant time effect in knee extension torque, but no time effects on LR and tendon force.
CONCLUSION


Patellar tendon LR is decreased along with degenerative change after TKA. Ultrasound imaging provides a promising metric to acquire in vivo patellar tendon pathological assessment after TKA.",2020,LR of the operated knee was significantly lower than LR of the nonoperated knee in relaxed (P < .001) and maximally loaded phases (P = .003).,['Twenty-eight participants with post unilateral TKA'],"['intervention group or control group', '12-week skiing program']","['Luminosity ratio (LR', 'knee extension torque', 'loading phase', 'surgical side', 'LR and tendon force', 'Quantitative Analysis of Patellar Tendon', 'LR of maximum phase and isometric knee extension torque', 'Patellar tendon mechanical properties']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0037264', 'cui_str': 'Skiing'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0871161', 'cui_str': 'Property'}]",28.0,0.050386,LR of the operated knee was significantly lower than LR of the nonoperated knee in relaxed (P < .001) and maximally loaded phases (P = .003).,"[{'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Department of Sport and Exercise Science, Paris Lodron University of Salzburg, Salzburg, Austria; Department of Orthopedic Surgery, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kösters', 'Affiliation': 'Department of Sport and Exercise Science, Paris Lodron University of Salzburg, Salzburg, Austria.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Rieder', 'Affiliation': 'Department of Sport and Exercise Science, Paris Lodron University of Salzburg, Salzburg, Austria; Department of Physical Medicine and Rehabilitation, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Takahisa', 'Initials': 'T', 'LastName': 'Sasho', 'Affiliation': 'Department of Orthopedic Surgery, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Müller', 'Affiliation': 'Department of Sport and Exercise Science, Paris Lodron University of Salzburg, Salzburg, Austria.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Wiesinger', 'Affiliation': 'Department of Sport and Exercise Science, Paris Lodron University of Salzburg, Salzburg, Austria.'}]",The Journal of arthroplasty,['10.1016/j.arth.2020.05.052']
3029,32561266,HTX-011 Reduced Pain and Opioid Use After Primary Total Knee Arthroplasty: Results of a Randomized Phase 2b Trial.,"BACKGROUND


HTX-011 is an extended-release, dual-acting local anesthetic consisting of bupivacaine and low-dose meloxicam in a novel polymer that is administered by needle-free application during surgery. The active ingredients are released from the polymer by controlled diffusion over 72 hours.
METHODS


This phase 2b, double-blind, placebo-controlled and active-controlled trial enrolled patients undergoing primary unilateral total knee arthroplasty under general anesthesia. Two hundred thirty-two patients were randomized into 4 groups: HTX-011 400 mg bupivacaine/12 mg meloxicam, applied without a needle into the surgical site, the same dose of HTX-011 with a separate 50 mg ropivacaine injection into the posterior capsule, bupivacaine hydrochloride (HCl) 125 mg injection, and saline placebo injection. Only opioids were permitted for postoperative pain rescue. Primary and key secondary endpoints were mean area under the curve of pain intensity scores over 48 hours and 72 hours, respectively, for HTX-011 groups vs placebo.
RESULTS


Both HTX-011 groups had significantly reduced mean pain intensity vs placebo through 48 and 72 hours (both P < .001). Ropivacaine added a small initial benefit in the first 12 hours. Both HTX-011 groups also had decreased mean pain intensity vs bupivacaine HCl alone through 48 and 72 hours (P < .05). The HTX-011 groups had significantly earlier discharge readiness along with lower opioid consumption through 72 hours. HTX-011 alone or with ropivacaine was well-tolerated with a safety profile similar to controls.
CONCLUSION


Needle-free application of HTX-011 400 mg bupivacaine/12 mg meloxicam provided superior pain reduction through 72 hours after total knee arthroplasty compared with placebo and bupivacaine HCl alone.",2020,Both HTX-011 groups had significantly reduced mean pain intensity vs placebo through 48 and 72 hours (both P < .001).,"['After Primary Total Knee Arthroplasty', 'patients undergoing primary unilateral total knee arthroplasty under general anesthesia', 'Two hundred thirty-two patients']","['bupivacaine HCl', 'bupivacaine', 'meloxicam', 'ropivacaine injection into the posterior capsule, bupivacaine hydrochloride (HCl) 125 mg injection, and saline placebo injection', 'ropivacaine', 'HTX-011 400 mg bupivacaine/12 mg meloxicam', 'Ropivacaine', 'placebo']","['mean pain intensity', 'earlier discharge readiness', 'postoperative pain rescue', 'Pain and Opioid Use', 'mean area under the curve of pain intensity scores', 'superior pain reduction']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0450357', 'cui_str': '32'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine hydrochloride'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0083381', 'cui_str': 'meloxicam'}, {'cui': 'C4080371', 'cui_str': 'ropivacaine Injection'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C3816746', 'cui_str': '400'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",232.0,0.326028,Both HTX-011 groups had significantly reduced mean pain intensity vs placebo through 48 and 72 hours (both P < .001).,"[{'ForeName': 'Paul F', 'Initials': 'PF', 'LastName': 'Lachiewicz', 'Affiliation': 'Department of Orthopaedic Surgery, Duke University, Chapel Hill, NC.'}, {'ForeName': 'Gwo-Chin', 'Initials': 'GC', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedic Surgery, University of Pennsylvania, Penn Medicine University City, Philadelphia, PA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Pollak', 'Affiliation': 'Endeavor Clinical Trials, San Antonio, TX.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Leiman', 'Affiliation': 'HD Research Corp, Houston, TX; Department of Surgery, University of Texas at Houston, Houston, TX.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Heron Therapeutics Inc, San Diego, CA.'}, {'ForeName': 'Alexander P', 'Initials': 'AP', 'LastName': 'Sah', 'Affiliation': 'Sah Orthopaedic Associates, Center for Joint Replacement Bldg, Fremont, CA.'}]",The Journal of arthroplasty,['10.1016/j.arth.2020.05.044']
3030,32561591,Quality of clinicians' conversations with patients and families before and after implementation of the Serious Illness Care Program in a hospital setting: a retrospective chart review study.,"BACKGROUND


Seriously ill patients in hospital have indicated that better communication with practitioners is vital for improving care. The aim of this study was to assess whether the quality of conversations about serious illness improved after implementation of the Serious Illness Care Program (SICP).
METHODS


In this retrospective chart review study, we evaluated patients who were admitted to a medical ward at Hamilton General Hospital, had a stay of at least 48 hours, and were at risk for a lengthy stay or increased need for community-based services (inter-RAI Emergency Department Screener score of 5 or 6). The SICP study period was from Mar. 1, 2017, to Jan. 19, 2018. We used a validated codebook to assess the quality of documented conversations regarding serious illness for eligible patients before (usual care [control group]) and after SICP implementation (intervention group), specifically examining the following domains: patients' values and goals, understanding of prognosis and illness, end-of-life care planning, and code status or desire for other life-sustaining treatments.
RESULTS


The study sample included 56 patients in the control group and 56 patients in the intervention group. The overall quality of documented conversations about serious illness was significantly higher in the intervention group than in the control group ( p  < 0.001) and was significantly higher in the subdomains of values and goals ( p  < 0.001), understanding of prognosis and illness ( p  < 0.001) and life-sustaining treatments ( p  = 0.03) but not end-of-life care planning ( p  = 0.48).
INTERPRETATION


Implementation of the SICP in a hospital setting was associated with higher quality of documented conversations regarding serious illness with patients at high risk for clinical or functional deterioration. The SICP is transferable and adaptable to a hospital setting, and was associated with an increase in adherence to best practices compared to usual care.",2020,"The overall quality of documented conversations about serious illness was significantly higher in the intervention group than in the control group ( p  < 0.001) and was significantly higher in the subdomains of values and goals ( p  < 0.001), understanding of prognosis and illness ( p  < 0.001) and life-sustaining treatments ( p  = 0.03) but not end-of-life care planning ( p  = 0.48).
","['56 patients in the control group and 56 patients in the intervention group', 'patients who were admitted to a medical ward at Hamilton General Hospital, had a stay of at least 48 hours, and were at risk for a lengthy stay or increased need for community-based services (inter-RAI Emergency Department Screener score of 5 or 6', 'eligible patients before (usual care [control group]) and after']",['SICP implementation (intervention group'],"['understanding of prognosis and illness', 'quality of conversations about serious illness', 'overall quality of documented conversations about serious illness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C3178806', 'cui_str': 'Right Atrial Isomerism'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1301725', 'cui_str': 'Documented'}]",56.0,0.0641132,"The overall quality of documented conversations about serious illness was significantly higher in the intervention group than in the control group ( p  < 0.001) and was significantly higher in the subdomains of values and goals ( p  < 0.001), understanding of prognosis and illness ( p  < 0.001) and life-sustaining treatments ( p  = 0.03) but not end-of-life care planning ( p  = 0.48).
","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': ""Michael G. DeGroote School of Medicine (Ma, Riehm), Faculty of Health Sciences, McMaster University, Hamilton, Ont.; Harvard Medical School (Bernacki, Paladino); Department of Psychosocial Oncology and Palliative Care (Bernacki), Dana-Farber Cancer Institute; Ariadne Labs (Bernacki, Paladino), Brigham and Women's Hospital and Harvard T.H. Chan School of Public Health; Department of Medicine (Bernacki, Paladino), Brigham and Women's Hospital, Boston, Mass.; Division of General Internal and Hospitalist Medicine (You), Trillium Health Partners, Mississauga, Ont.; Departments of Medicine and of Health Research Methods, Evidence, and Impact (You), McMaster University, Hamilton, Ont.""}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Riehm', 'Affiliation': ""Michael G. DeGroote School of Medicine (Ma, Riehm), Faculty of Health Sciences, McMaster University, Hamilton, Ont.; Harvard Medical School (Bernacki, Paladino); Department of Psychosocial Oncology and Palliative Care (Bernacki), Dana-Farber Cancer Institute; Ariadne Labs (Bernacki, Paladino), Brigham and Women's Hospital and Harvard T.H. Chan School of Public Health; Department of Medicine (Bernacki, Paladino), Brigham and Women's Hospital, Boston, Mass.; Division of General Internal and Hospitalist Medicine (You), Trillium Health Partners, Mississauga, Ont.; Departments of Medicine and of Health Research Methods, Evidence, and Impact (You), McMaster University, Hamilton, Ont.""}, {'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Bernacki', 'Affiliation': ""Michael G. DeGroote School of Medicine (Ma, Riehm), Faculty of Health Sciences, McMaster University, Hamilton, Ont.; Harvard Medical School (Bernacki, Paladino); Department of Psychosocial Oncology and Palliative Care (Bernacki), Dana-Farber Cancer Institute; Ariadne Labs (Bernacki, Paladino), Brigham and Women's Hospital and Harvard T.H. Chan School of Public Health; Department of Medicine (Bernacki, Paladino), Brigham and Women's Hospital, Boston, Mass.; Division of General Internal and Hospitalist Medicine (You), Trillium Health Partners, Mississauga, Ont.; Departments of Medicine and of Health Research Methods, Evidence, and Impact (You), McMaster University, Hamilton, Ont.""}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Paladino', 'Affiliation': ""Michael G. DeGroote School of Medicine (Ma, Riehm), Faculty of Health Sciences, McMaster University, Hamilton, Ont.; Harvard Medical School (Bernacki, Paladino); Department of Psychosocial Oncology and Palliative Care (Bernacki), Dana-Farber Cancer Institute; Ariadne Labs (Bernacki, Paladino), Brigham and Women's Hospital and Harvard T.H. Chan School of Public Health; Department of Medicine (Bernacki, Paladino), Brigham and Women's Hospital, Boston, Mass.; Division of General Internal and Hospitalist Medicine (You), Trillium Health Partners, Mississauga, Ont.; Departments of Medicine and of Health Research Methods, Evidence, and Impact (You), McMaster University, Hamilton, Ont.""}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'You', 'Affiliation': ""Michael G. DeGroote School of Medicine (Ma, Riehm), Faculty of Health Sciences, McMaster University, Hamilton, Ont.; Harvard Medical School (Bernacki, Paladino); Department of Psychosocial Oncology and Palliative Care (Bernacki), Dana-Farber Cancer Institute; Ariadne Labs (Bernacki, Paladino), Brigham and Women's Hospital and Harvard T.H. Chan School of Public Health; Department of Medicine (Bernacki, Paladino), Brigham and Women's Hospital, Boston, Mass.; Division of General Internal and Hospitalist Medicine (You), Trillium Health Partners, Mississauga, Ont.; Departments of Medicine and of Health Research Methods, Evidence, and Impact (You), McMaster University, Hamilton, Ont. John.You@thp.ca.""}]",CMAJ open,['10.9778/cmajo.20190193']
3031,32561603,Combination of human umbilical cord mesenchymal stem (stromal) cell transplantation with IFN-γ treatment synergistically improves the clinical outcomes of patients with rheumatoid arthritis.,"OBJECTIVES


To clarify the key role of circulating interferon-γ (IFN-γ) and to improve the clinical efficacy of mesenchymal stem cell (MSC) transplantation (MSCT) in patients with rheumatoid arthritis (RA).
METHODS


Study of wild-type or IFN-γR -/-  MSCT was first evaluated in a murine model of collagen-induced arthritis (CIA) following which a phase 1/2 randomised controlled study was conducted in 63 patients with RA who responded poorly to regular clinical treatments. Subjects were randomly assigned to an MSCT monotherapy group (n=32) or an MSCT plus recombinant human IFN-γ treatment group (n=31), with 1 year of follow-up. The primary end points consisted of efficacy as assessed as good or moderate EULAR response rates and the proportion of patients at 3 months attaining American College of Rheumatology 20 (ACR20) response rates.
RESULTS


In the murine studies, wild-type MSCT significantly improved the clinical severity of CIA, while IFN-γR -/-  MSCT aggravated synovitis, and joint and cartilage damage. Transitioning from the murine to the clinical study, the 3-month follow-up results showed that the efficacy and ACR20 response rates were attained in 53.3% patients with MSCT monotherapy and in 93.3% patients with MSCT combined with IFN-γ treatment (p<0.05). No new or unexpected safety issues were encountered in 1-year follow-up for either treatment group.
CONCLUSIONS


The results of this study show that IFN-γ is a key factor in determining the efficacy of MSCT in the treatment of RA, and that an MSC plus IFN-γ combination therapeutic strategy can greatly improve the clinical efficacy of MSC-based therapy in RA patients.",2020,"No new or unexpected safety issues were encountered in 1-year follow-up for either treatment group.
","['RA patients', '63 patients with RA who responded poorly to regular clinical treatments', 'patients with rheumatoid arthritis (RA', 'patients with rheumatoid arthritis', 'Study of wild-type or']","['circulating interferon-γ (IFN-γ', 'IFN-γ', 'IFN-γR -/-  MSCT', 'MSCT monotherapy', 'mesenchymal stem cell (MSC) transplantation (MSCT', 'human umbilical cord mesenchymal stem (stromal) cell transplantation with IFN-γ', 'MSCT plus recombinant human IFN-γ treatment']","['efficacy and ACR20 response rates', 'clinical severity of CIA, while IFN-γR -/-  MSCT aggravated synovitis, and joint and cartilage damage', 'good or moderate EULAR response rates and the proportion of patients at 3 months attaining American College of Rheumatology 20 (ACR20) response rates']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205169', 'cui_str': 'Bad'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C1257990', 'cui_str': 'Stem Cell Transplantation, Mesenchymal'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0170509', 'cui_str': 'CyADIC protocol'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0436331', 'cui_str': 'Symptom aggravating factors'}, {'cui': 'C0039103', 'cui_str': 'Synovitis'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0549421', 'cui_str': 'Cartilage damage'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}]",63.0,0.0328702,"No new or unexpected safety issues were encountered in 1-year follow-up for either treatment group.
","[{'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Stem Cell & Regenerative Medicine, Third Military Medical University Daping Hospital and Research Institute of Surgery, Chongqing, China xiangxu@tmmu.edu.cn.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Stem Cell & Regenerative Medicine, Third Military Medical University Daping Hospital and Research Institute of Surgery, Chongqing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Stem Cell & Regenerative Medicine, Third Military Medical University Daping Hospital and Research Institute of Surgery, Chongqing, China.'}, {'ForeName': 'Mengwei', 'Initials': 'M', 'LastName': 'Yao', 'Affiliation': 'Department of Stem Cell & Regenerative Medicine, Third Military Medical University Daping Hospital and Research Institute of Surgery, Chongqing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""Force Health Team of 61365 Troops of the Chinese People's Liberation Army, Tianjin, China.""}, {'ForeName': 'Luoquan', 'Initials': 'L', 'LastName': 'Ao', 'Affiliation': 'Department of Stem Cell & Regenerative Medicine, Third Military Medical University Daping Hospital and Research Institute of Surgery, Chongqing, China.'}, {'ForeName': 'Xueting', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Stem Cell & Regenerative Medicine, Third Military Medical University Daping Hospital and Research Institute of Surgery, Chongqing, China.'}, {'ForeName': 'Zhan', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Stem Cell & Regenerative Medicine, Third Military Medical University Daping Hospital and Research Institute of Surgery, Chongqing, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Stem Cell & Regenerative Medicine, Third Military Medical University Daping Hospital and Research Institute of Surgery, Chongqing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'Department of Stem Cell & Regenerative Medicine, Third Military Medical University Daping Hospital and Research Institute of Surgery, Chongqing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xing', 'Affiliation': 'Department of Stem Cell & Regenerative Medicine, Third Military Medical University Daping Hospital and Research Institute of Surgery, Chongqing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': 'Department of Stem Cell & Regenerative Medicine, Third Military Medical University Daping Hospital and Research Institute of Surgery, Chongqing, China.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Bellanti', 'Affiliation': 'Departments of Pediatrics and Microbiology-Immunology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Song Guo', 'Initials': 'SG', 'LastName': 'Zheng', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Ohio State University College of Medicine and Wexner Medical Center, Columbus, Ohio, USA.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217798']
3032,32561662,"Prognostic Value of EndoPredict in Women with Hormone Receptor Positive, HER2-Negative Invasive Lobular Breast Cancer.","PURPOSE


Invasive lobular carcinoma (ILC) accounts for approximately 5-15% of all invasive breast cancer cases. Most of the correlations between multigene assays and patient outcome were derived from studies based on patients with invasive ductal carcinoma (IDC) or without distinction between the subtypes. Here, we investigate the prognostic value of EndoPredict in a large cohort of ILCs pooled from three phase III randomized trials (ABCSG-6, ABCSG-8, TransATAC).
EXPERIMENTAL DESIGN


The primary objective of this analysis was to determine the prognostic value of EndoPredict (EPclin) for distant recurrence in years 0-10 in postmenopausal women with ILC. The primary outcome was distant recurrence (DR).
RESULTS


470 women (17.9%) presented with ILC, 1944 (73.9%) with IDC, and 216 (8.2%) had other histological types. EPclin was highly prognostic in women with ILC (HR=3.32 (2.54-4.34)) and provided more prognostic value than the Clinical Treatment Score (CTS) (HR=2.17 (1.73-2.72)). 63.4% women were categorised into the low EPclin risk group and they had a 10-year DR of 4.8% (2.7-8.4) compared to 36.6% of women in the high risk group with a 10-year DR risk of 26.6% (20.0-35.0). EPclin also provided highly prognostic information in women with node-negative disease (HR=2.56 (1.63-4.02)) and node-positive disease (HR=3.70 (2.49-5.50)).
CONCLUSIONS


EPclin provided highly significant prognostic value and significant risk stratification for women with ILC. 10-year DR risk in the EPclin low risk groups were similar between ILC and IDC. Our results show that EPclin is informative in women with ILC and suggest that it is equally valid in both histological subtypes.",2020,"CONCLUSIONS


EPclin provided highly significant prognostic value and significant risk stratification for women with ILC","['Women with Hormone Receptor Positive, HER2-Negative Invasive Lobular Breast Cancer', 'women with ILC', 'distant recurrence in years 0-10 in postmenopausal women with ILC', 'patients with invasive ductal carcinoma (IDC', '470 women (17.9%) presented with ILC, 1944 (73.9%) with IDC, and 216 (8.2%) had other histological types']","['EndoPredict (EPclin', 'EPclin']","[' 10-year DR risk', '10-year DR risk', '10-year DR', 'node-positive disease', 'distant recurrence (DR']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0205417', 'cui_str': 'Lobular'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206692', 'cui_str': 'Lobular carcinoma'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1134719', 'cui_str': 'Infiltrating ductular carcinoma'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0449574', 'cui_str': 'Histologic type'}]",[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",470.0,0.177538,"CONCLUSIONS


EPclin provided highly significant prognostic value and significant risk stratification for women with ILC","[{'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Sestak', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University i.sestak@qmul.ac.uk.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Filipits', 'Affiliation': 'Institute of Cancer Research, Department of Medicine I, Medical University of Vienna, Comprehensive Cancer Center.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Buus', 'Affiliation': 'Breast Cancer Research, Institute of Cancer Research.'}, {'ForeName': 'Margaretha', 'Initials': 'M', 'LastName': 'Rudas', 'Affiliation': 'Department of Pathology, Medical University of Vienna.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Balic', 'Affiliation': 'Departement, Medical University of Graz.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Knauer', 'Affiliation': 'Breast Surgery, Breast Center Eastern Switzerland.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Kronenwett', 'Affiliation': 'Medical Affairs, Myriad International GmbH.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Fitzal', 'Affiliation': 'Department of Surgery, Medical University of Vienna.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Cuzick', 'Affiliation': 'Centre for Cancer Prevention, Queen Mary University of London.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gnant', 'Affiliation': 'Department of Surgery, Medical University of Vienna.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'Department of Internal Medicine III, Salzburg Cancer Research Institute - Laboratory for Immunological and Molecular Cancer Research (SCRI-LIMCR), Paracelsus Medical University Salzburg.'}, {'ForeName': 'Mitch', 'Initials': 'M', 'LastName': 'Dowsett', 'Affiliation': 'Ralph Lauren Centre for Breast Cancer Research, Royal Marsden Hospital.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dubsky', 'Affiliation': 'Breast Centre, Hirslanden Klinik St. Anna.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0260']
3033,32561663,Efficacy and safety exposure-response relationships of apalutamide in patients with non-metastatic castration-resistant prostate cancer.,"PURPOSE


To evaluate the relationship between exposure of apalutamide and its active metabolite, N-desmethyl-apalutamide, and selected clinical efficacy and safety parameters in men with high risk non-metastatic castration-resistant prostate cancer.
PATIENTS AND METHODS


An exploratory exposure-response analysis was undertaken using data from the 1207 patients (806 apalutamide and 401 placebo) enrolled in the SPARTAN study, including those who had undergone dose reductions and dose interruptions. Univariate and multivariate Cox regression models evaluated the relationships between apalutamide and N-desmethyl-apalutamide exposure, expressed as area under the concentration-time curve at steady state, and metastasis-free survival (MFS). Univariate and multivariate logistic regression models assessed the relationship between apalutamide and N-desmethyl-apalutamide exposure and common treatment-emergent adverse events including fatigue, fall, skin rash, weight loss, and arthralgia.
RESULTS


A total of 21% of patients in the apalutamide arm experienced dose reductions diminishing the average daily dose to 209 mg instead of 240 mg. Within the relatively narrow exposure range, no statistically significant relationship was found between MFS and apalutamide and N-desmethyl-apalutamide exposure. Within apalutamide treated subjects, skin rash and weight loss had a statistically significant association with higher apalutamide exposure.
CONCLUSIONS


The use of apalutamide at the recommended dose of 240 mg once daily provided a similar delay in metastases across the SPARTAN patient population, regardless of exposure. The exploratory exposure-safety analysis supports dose reductions in patients experiencing adverse events.",2020,"Univariate and multivariate Cox regression models evaluated the relationships between apalutamide and N-desmethyl-apalutamide exposure, expressed as area under the concentration-time curve at steady state, and metastasis-free survival (MFS).","['patients experiencing adverse events', '1207 patients (806 apalutamide and 401 placebo) enrolled in the SPARTAN study, including those who had undergone dose reductions and dose interruptions', 'patients with non-metastatic castration-resistant prostate cancer', 'men with high risk non-metastatic castration-resistant prostate cancer']",['apalutamide'],"['fatigue, fall, skin rash, weight loss, and arthralgia', 'skin rash and weight loss', 'concentration-time curve at steady state, and metastasis-free survival (MFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4329353', 'cui_str': 'apalutamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C4329353', 'cui_str': 'apalutamide'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",1207.0,0.0463377,"Univariate and multivariate Cox regression models evaluated the relationships between apalutamide and N-desmethyl-apalutamide exposure, expressed as area under the concentration-time curve at steady state, and metastasis-free survival (MFS).","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Perez-Ruixo', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, Janssen Research and Development.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Ackaert', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, Janssen Research and Development oackaert@its.jnj.com.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Ouellet', 'Affiliation': 'Janssen Research & Development.'}, {'ForeName': 'Caly', 'Initials': 'C', 'LastName': 'Chien', 'Affiliation': 'Clinical Pharmacology & Pharmacometrics, Janssen Research & Development.'}, {'ForeName': 'Hiroji', 'Initials': 'H', 'LastName': 'Uemura', 'Affiliation': 'Urology and Renal Transplantation, Yokohama City University Medical Center, Yokohama.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Olmos', 'Affiliation': 'Clinical Research programme, Spanish National Cancer Research Centre.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Mainwaring', 'Affiliation': 'Centre for Personalised Nanomedicine, University of Queensland, Brisbane.'}, {'ForeName': 'Ji Youl', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Urology, Catholic University of Korea.'}, {'ForeName': 'Margaret K', 'Initials': 'MK', 'LastName': 'Yu', 'Affiliation': 'WC Clinical Oncology, Janssen Research & Development.'}, {'ForeName': 'Juan Jose', 'Initials': 'JJ', 'LastName': 'Perez Ruixo', 'Affiliation': 'Clinical Pharmacology & Pharmacometrics, Janssen Research & Development.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Smith', 'Affiliation': 'Hematology-Oncology, Massachusetts General Hospital Cancer Center and Harvard Medical School.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Small', 'Affiliation': 'Medical Oncology, Helen Diller Family Comprehensive Cancer Center, University of California San Francisco.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-1041']
3034,32562075,"Sealer penetration: effect of separated file's cross-section, taper and motion characteristics.","OBJECTIVES


The separated root canal instruments may affect the quality of root canal filling, hence the success of endodontic treatment. The aim of this study was to evaluate the effects of separated file fragments of nickel-titanium rotary systems with different cross-section, taper and motion characteristics on the apical sealer penetration in oval-shaped root canals via confocal laser scanning microscope (CLSM).
MATERIALS AND METHODS


Distal roots of 60 mandibular molars with oval-shaped root canals were randomly divided into 4 groups as follows: group 1, FlexMaster Nickel Titanium Rotary File System (NTRFS) (separated instrument: 30/.06); group 2, ProTaper Next NTRFS (X3); group 3, ProTaper Universal NTRFS (F3); group 4, Revo-S NTRFS (AS30/.06). Root canals were filled with gutta-percha and AH plus labelled with 0.1% rhodamine B using a warm vertical compaction technique. Each specimen was horizontally sectioned at 1st, 3rd and 5th mm from apical foramen. Amount of maximum and average penetration depths, penetration percentage and sealer penetrated area were measured and analysed with one-way repeated measures of ANOVA and the Bonferroni post hoc tests. p < 0.05 was considered significant.
RESULTS


The penetration depth, percentage and penetrated area of the sealer increased from apical to coronal in all systems. The maximum and average penetration depths and penetration areas were higher in FlexMaster and Revo-S groups at the 3rd mm (p < 0.05). At the 5th mm, the Revo-S group had a higher penetration percentage, when compared with ProTaper Next and ProTaper Universal groups (p < 0.05).
CONCLUSIONS


In the 1st mm, separated fragments of any system did not allow the penetration of the sealer, while it was observed that the files with constant taper showed more positive results in terms of sealer penetration at apical 3rd and 5th mm.
CLINICAL RELEVANCE


In the presence of a separated file, the taper of the file might significantly affect the amount of penetrated sealer into the dentinal tubules as compared with the cross-section and motion characteristics of the file.",2020,The maximum and average penetration depths and penetration areas were higher in FlexMaster and Revo-S groups at the 3rd mm (p < 0.05).,['Distal roots of 60 mandibular molars with oval-shaped root canals'],"['gutta-percha and AH plus labelled with 0.1% rhodamine B using a warm vertical compaction technique', 'FlexMaster Nickel Titanium Rotary File System (NTRFS) (separated instrument: 30/.06); group 2, ProTaper Next NTRFS (X3); group 3, ProTaper Universal NTRFS (F3']","['Amount of maximum and average penetration depths, penetration percentage and sealer penetrated area', 'quality of root canal filling', 'penetration depth, percentage and penetrated area of the sealer', 'maximum and average penetration depths and penetration areas']","[{'cui': 'C0447373', 'cui_str': 'Distal tooth root'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}]","[{'cui': 'C0018407', 'cui_str': 'Gutta percha'}, {'cui': 'C0673096', 'cui_str': 'AH Plus'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0073194', 'cui_str': 'Rhodamine B'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0068790', 'cui_str': 'nitinol'}, {'cui': 'C0016094', 'cui_str': 'Filing'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0175671', 'cui_str': 'Universal'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0449942', 'cui_str': 'Sealer'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0035848', 'cui_str': 'Root canal obturation'}]",,0.0436713,The maximum and average penetration depths and penetration areas were higher in FlexMaster and Revo-S groups at the 3rd mm (p < 0.05).,"[{'ForeName': 'Ayhan', 'Initials': 'A', 'LastName': 'Eymirli', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Hacettepe University, Sihhiye, 06100, Ankara, Turkey.'}, {'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Uzunoğlu Özyürek', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Hacettepe University, Sihhiye, 06100, Ankara, Turkey. emel_dt@hotmail.com.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Serper', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Hacettepe University, Sihhiye, 06100, Ankara, Turkey.'}]",Clinical oral investigations,['10.1007/s00784-020-03404-3']
3035,32562077,Healing of periodontal suprabony defects following treatment with open flap debridement with or without an enamel matrix derivative: A randomized controlled clinical study.,"OBJECTIVES


To compare the healing of suprabony defects following treatment with either open flap debridement (OFD) and application of an enamel matrix derivative (EMD) with OFD alone.
METHODS


Eighty patients with suprabony periodontal defects were randomly assigned to treatment with OFD + EMD (test) or OFD alone (control). The primary outcome variable was the difference in clinical attachment level (CAL) gain. At baseline and after 12 months, full-mouth plaque scores (FMPS), full-mouth bleeding scores (FMBS), probing depths (PD), gingival recessions (GR), and CAL were recorded.
RESULTS


Sixty-five patients were available for the 12-month follow-up examination. At 12 months, the mean FMPS was 21.9 ± 3.0% in the OFD + EMD and 21.1 ± 2.4% in the OFD group, respectively (p = 0.30), while mean FMBS measured 20.4 ± 3.4% in the OFD + EMD group and 19.9 ± 2.9% in the OFD group (p = 0.48). Mean CAL gain at sites treated with OFD + EMD was statistically significantly different (p = 0.0001) compared with sites treated with OFD alone (3.4 ± 0.6 mm vs 1.8 ± 0.6 mm). A statistically significant difference (p = 0.0001) was found between mean PD change in the OFD + EMD (3.9 ± 0.6 mm) and OFD alone (3.2 ± 0.6 mm) treated groups and also in terms of mean GR change between treatment with OFD + EMD (0.5 ± 0.7 mm) and OFD alone (1.4 ± 1.0 mm) (p = 0.001).
CONCLUSION


Within their limits, the present results indicate that in suprabony periodontal defects, the application of EMD in conjunction with OFD may additionally improve the clinical outcomes compared with OFD alone.
CLINICAL RELEVANCE


In periodontal suprabony defects, the application of EMD in conjunction with OFD may additionally enhance the clinical outcomes in terms of CAL gain and PD reduction.",2020,Mean CAL gain at sites treated with OFD + EMD was statistically significantly different (p = 0.0001) compared with sites treated with OFD alone (3.4 ± 0.6 mm vs 1.8 ± 0.6 mm).,"['Sixty-five patients were available for the 12-month follow-up examination', 'Eighty patients with suprabony periodontal defects']","['open flap debridement (OFD) and application of an enamel matrix derivative (EMD) with OFD alone', 'OFD + EMD', 'open flap debridement with or without an enamel matrix derivative', 'OFD + EMD (test) or OFD alone (control']","['full-mouth plaque scores (FMPS), full-mouth bleeding scores (FMBS), probing depths (PD), gingival recessions (GR), and CAL', 'Mean CAL gain', 'mean PD change in the OFD + EMD', 'healing of suprabony defects', 'mean GR change', 'mean FMPS', 'clinical attachment level (CAL) gain']","[{'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0221732', 'cui_str': 'Mouth plaque'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",80.0,0.0935902,Mean CAL gain at sites treated with OFD + EMD was statistically significantly different (p = 0.0001) compared with sites treated with OFD alone (3.4 ± 0.6 mm vs 1.8 ± 0.6 mm).,"[{'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Iorio-Siciliano', 'Affiliation': 'Department of Periodontology, University of Naples Federico II, Via S Pansini 5, 80131, Naples, Italy. enzois@libero.it.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Blasi', 'Affiliation': 'Department of Periodontology, University of Naples Federico II, Via S Pansini 5, 80131, Naples, Italy.'}, {'ForeName': 'Stefan-Ioan', 'Initials': 'SI', 'LastName': 'Stratul', 'Affiliation': 'Department of Periodontology, Victor Babes University, Piata Eftimie 2, 300041, Timisoara, Romania.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Ramaglia', 'Affiliation': 'Department of Periodontology, University of Naples Federico II, Via S Pansini 5, 80131, Naples, Italy.'}, {'ForeName': 'Vela', 'Initials': 'V', 'LastName': 'Octavia', 'Affiliation': 'Department of Periodontology, Victor Babes University, Piata Eftimie 2, 300041, Timisoara, Romania.'}, {'ForeName': 'Giovanni E', 'Initials': 'GE', 'LastName': 'Salvi', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Bern, Freiburgstrasse 7, CH-3010, Bern, Switzerland.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Sculean', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Bern, Freiburgstrasse 7, CH-3010, Bern, Switzerland.'}]",Clinical oral investigations,['10.1007/s00784-020-03392-4']
3036,32562103,Barbershop Management of Hypertension in the African American Population: Pitfalls and Opportunities for Extension to Other Underserved Communities.,"PURPOSE OF REVIEW


This review summarizes the results of recent barbershop-based studies focusing on the diagnosis and management of hypertension (HTN) in black adults. The pitfalls of prior attempts and opportunities for the development of future programs to address health disparities on a larger scale are also reviewed.
RECENT FINDINGS


While barbershop health outreach has become a commonplace in recent years, the quality of the evidence on the effectiveness of such programs has been weak, until the Los Angeles Barbershop Blood Pressure Study (LABBPS), a rigorously carried out cluster-randomized trial, demonstrated a - 21 mmHg greater reduction in BP among black hypertensive men who were assigned to a pharmacist-led HTN intervention when compared with usual care. Given the available evidence, barber health promotion paired with focused hypertension-specialty care has the potential to reduce, if not eliminate, the present wide gap in hypertension care and ultimately lead to a reduction of hypertension-related complications among blacks. Future research should seek to improve the scalability and transferability of the LABBPS model both to other geographic regions and to other at-risk groups.",2020,Future research should seek to improve the scalability and transferability of the LABBPS model both to other geographic regions and to other at-risk groups.,"['black hypertensive men', 'black adults']",['pharmacist-led HTN intervention'],[],"[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0162602,Future research should seek to improve the scalability and transferability of the LABBPS model both to other geographic regions and to other at-risk groups.,"[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Ebinger', 'Affiliation': 'Cedars-Sinai Medical Center, Smidt Heart Institute, 127 S. San Vicente Blvd., Ste. A3600, Los Angeles, CA, 90048, USA. Joseph.Ebinger@csmc.edu.'}, {'ForeName': 'Ciantel A', 'Initials': 'CA', 'LastName': 'Blyler', 'Affiliation': 'Cedars-Sinai Medical Center, Smidt Heart Institute, 127 S. San Vicente Blvd., Ste. A3600, Los Angeles, CA, 90048, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Brettler', 'Affiliation': 'Kaiser-Permanente, Los Angeles, CA, USA.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Rader', 'Affiliation': 'Cedars-Sinai Medical Center, Smidt Heart Institute, 127 S. San Vicente Blvd., Ste. A3600, Los Angeles, CA, 90048, USA.'}]",Current cardiology reports,['10.1007/s11886-020-01319-9']
3037,32562153,"""Prophylactic"" transanal irrigation (TAI) to prevent symptoms of low anterior resection syndrome (LARS) after rectal resection: results at 12-month follow-up of a controlled randomized multicenter trial.","BACKGROUND


Low anterior resection syndrome (LARS) is associated with a severe negative impact on patients' quality of life (QOL). In a recent prospective randomized controlled trial (RCT) by our group, early (""prophylactic"") use of transanal irrigation (TAI) following rectal resection for rectal cancer was shown to improve symptoms associated with LARS significantly compared with a group under supportive therapy (ST) within 1 and 3 months following closure of the protective ileostomy. The aim of the present study was to evaluate the outcome after 12 months when patients had the option to choose between the two therapeutic options and/or modify the regimen of TAI (volume and time).
METHODS


In the RCT, 18 patients had been allocated to start with TAI following ileostomy closure, while 19 patients remained on ST only. Once the 3-month follow-up had been completed patients could choose between TAI or ST, respectively, and were invited for follow-up after 12 months. The maximum number of bowel movements during the day and the Wexner and LARS score as well as physical (PC) and mental (MC) component of the SF-36 questionnaire were evaluated. Furthermore, in patients who had changed their treatment arm, reasons for this decision were reported.
RESULTS


Six patients were lost to follow-up (all in the ST group). One patient from the ST group started with TAI due to problems associated with LARS, bringing the total number of TAI patients to 19. Nine patients from the previous TAI arm changed to ST due to the long duration of the emptying process (n: 8) or pain during TAI (n: 1), respectively. After 12 months, the median volume of water used for irrigation was 600 ml (range 200-1000 ml). The ten patients who continued with TAI patients showed a lower number of defecation episodes per daytime (TAI median 3; 1-6, ST median 5; 2-10, p: 0.018) and per night (TAI median 0; 0-1, ST median 1; 0-5, p: 0.004) compared to the ST group. Although the LARS score was lower in patients who used TAI after 12 months (TAI median 18; 9-32, ST median 30; 3-39), this failed to reach the level of significance (p: 0.063). Evaluation of the Wexner score and the 36-item Short Form Health Survey as well as comparison of patients who remained on TAI (n: 9) versus those who had stopped TAI after 3 months (n: 9) failed to find any statistically significant difference between TAI and ST.
CONCLUSIONS


This follow-up study revealed that a considerable number of patients decided to stop TAI within 12 months. However, the number of bowel movements during the day were still lower when TAI was used than when patients had ST only.
CATEGORY


Randomized trial.
REGISTRATION NUMBER


DRKS00011752, https://apps.who.int/trialsearch/.",2020,"However, the number of bowel movements during the day were still lower when TAI was used than when patients had ST only.
","['Low anterior resection syndrome (LARS', 'low anterior resection syndrome (LARS) after rectal resection', 'patients had the option to choose between the two therapeutic options and/or modify the regimen of TAI (volume and time']","['Prophylactic"" transanal irrigation (TAI', 'transanal irrigation (TAI']","['LARS score', 'maximum number of bowel movements', 'median volume of water used for irrigation', 'Wexner and LARS score as well as physical (PC) and mental (MC) component of the SF-36 questionnaire', 'number of defecation episodes per daytime', 'number of bowel movements']","[{'cui': 'C4524073', 'cui_str': 'Low anterior resection syndrome'}, {'cui': 'C0193062', 'cui_str': 'Resection of rectum'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0589371', 'cui_str': 'Transanal approach'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0589371', 'cui_str': 'Transanal approach'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}]","[{'cui': 'C4524073', 'cui_str': 'Low anterior resection syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}]",6.0,0.0570626,"However, the number of bowel movements during the day were still lower when TAI was used than when patients had ST only.
","[{'ForeName': 'H R', 'Initials': 'HR', 'LastName': 'Rosen', 'Affiliation': 'Faculty of Surgical Oncology, Sigmund Freud University, Vienna, Freudplatz 3, 1020, Vienna, Austria. rosensurg@csi.com.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Boedecker', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Fürst', 'Affiliation': 'Department of Surgery, Caritas-Hospital St. Josef, Regensburg, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Krämer', 'Affiliation': 'Department of Surgery, Caritas-Hospital St. Josef, Regensburg, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hebenstreit', 'Affiliation': 'Department of Surgery, Hospital St. John of God, Graz, Austria.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Kneist', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Johannes Gutenberg University, Mainz, Germany.'}]",Techniques in coloproctology,['10.1007/s10151-020-02261-2']
3038,32562194,Translating clinical and patient-reported data to tailored shared decision reports with predictive analytics for knee and hip arthritis.,"INTRODUCTION


New informatics tools can transform evidence-based information to individualized predictive reports to serve shared decisions in clinic. We developed a web-based system to collect patient-reported outcomes (PROs) and medical risk factors and to compare responses to national registry data. The system generates predicted outcomes for individual patients and a report for use in clinic to support decisions. We present the report development, presentation, and early experience implementing this PRO-based, shared decision report for knee and hip arthritis patients seeking orthopedic evaluation.
METHODS


Iterative patient and clinician interviews defined report content and visual display. The web-system supports: (a) collection of PROs and risk data at home or in office, (b) automated statistical processing of responses compared to national data, (c) individualized estimates of likely pain relief and functional gain if surgery is elected, and (d) graphical reports to support shared decisions. The system was implemented at 12 sites with 26 surgeons in an ongoing cluster randomized trial.
RESULTS


Clinicians and patients recommended that pain and function as well as clinical risk factors (e.g., BMI, smoking) be presented to frame the discussion. Color and graphics support patient understanding. To date, 7891 patients completed the assessment before the visit and 56% consented to study participation. Reports were generated for 98% of patients and 68% of patients recalled reviewing the report with their surgeon.
CONCLUSIONS


Informatics solutions can generate timely, tailored office reports including PROs and predictive analytics. Patients successfully complete the pre-visit PRO assessments and clinicians and patients value the report to support shared surgical decisions.",2020,"Reports were generated for 98% of patients and 68% of patients recalled reviewing the report with their surgeon.
","['Iterative patient and clinician interviews defined report content and visual display', 'knee and hip arthritis patients seeking orthopedic evaluation', '7891 patients completed the assessment before the visit and 56% consented to study participation']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0263776', 'cui_str': 'Arthritis of hip'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],[],7891.0,0.0219891,"Reports were generated for 98% of patients and 68% of patients recalled reviewing the report with their surgeon.
","[{'ForeName': 'Patricia D', 'Initials': 'PD', 'LastName': 'Franklin', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, 625 North Michigan Ave, Room 21-051, Chicago, IL, 60611, USA. Patricia.franklin@northwestern.edu.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'University of Massachusetts Medical School, Worcester, MA, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Bond', 'Affiliation': 'Patient Research Group, LLC, Syracuse, NY, USA.'}, {'ForeName': 'Danielle C', 'Initials': 'DC', 'LastName': 'Lavallee', 'Affiliation': 'University of Washington School of Medicine, Seattle, WA, USA.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-020-02557-8']
3039,32445969,How do oncoming traffic and cyclist lane position influence cyclist overtaking by drivers?,"Overtaking cyclists is challenging for drivers because it requires a well-timed, safe interaction between the driver, the cyclist, and the oncoming traffic. Previous research has investigated this manoeuvre in different experimental environments, including naturalistic driving, naturalistic cycling, and simulator studies. These studies highlight the significance of oncoming traffic-but did not extensively examine the influence of the cyclist's position within the lane. In this study, we performed a test-track experiment to investigate how oncoming traffic and position of the cyclist within the lane influence overtaking. Participants overtook a robot cyclist, which was controlled to ride in two different lateral positions within the lane. At the same time, an oncoming robot vehicle was controlled to meet the participant's vehicle with either 6 or 9 s time-to-collision. The order of scenarios was randomised over participants. We analysed safety metrics for the four different overtaking phases, reflecting drivers' safety margins to rear-end, head-on, and side-swipe collisions, in order to investigate the two binary factors: 1) time gap between ego vehicle and oncoming vehicle, and 2) cyclist lateral position. Finally, the effects of these two factors on the safety metrics and the overtaking strategy (either flying or accelerative depending on whether the overtaking happened before or after the oncoming vehicle had passed) were analysed. The results showed that, both when the cyclist rode closer to the centre of the lane and when the time gap to the oncoming vehicle was shorter, safety margins for all potential collisions decreased. Under these conditions, drivers-particularly female drivers-preferred accelerative over flying manoeuvres. Bayesian statistics modelled these results to inform the development of active safety systems that can support drivers in safely overtaking cyclists.",2020,Bayesian statistics modelled these results to inform the development of active safety systems that can support drivers in safely overtaking cyclists.,[],[],[],[],[],[],,0.0264438,Bayesian statistics modelled these results to inform the development of active safety systems that can support drivers in safely overtaking cyclists.,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Rasch', 'Affiliation': 'Department of Mechanics and Maritime Sciences, Chalmers University of Technology, Hörselgången 4, 41756 Göteborg, Sweden. Electronic address: alexander.rasch@chalmers.se.'}, {'ForeName': 'Christian-Nils', 'Initials': 'CN', 'LastName': 'Boda', 'Affiliation': 'Department of Mechanics and Maritime Sciences, Chalmers University of Technology, Hörselgången 4, 41756 Göteborg, Sweden. Electronic address: christian-nils.boda@chalmers.se.'}, {'ForeName': 'Prateek', 'Initials': 'P', 'LastName': 'Thalya', 'Affiliation': 'Department of Mechanics and Maritime Sciences, Chalmers University of Technology, Hörselgången 4, 41756 Göteborg, Sweden; Veoneer Research, Veoneer Sweden AB, Wallentinsvägen 22, 44737 Vårgårda, Sweden. Electronic address: prateek.thalya@veoneer.com.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Aderum', 'Affiliation': 'Veoneer Research, Veoneer Sweden AB, Wallentinsvägen 22, 44737 Vårgårda, Sweden. Electronic address: tobias.aderum@veoneer.com.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Knauss', 'Affiliation': 'Veoneer Research, Veoneer Sweden AB, Wallentinsvägen 22, 44737 Vårgårda, Sweden. Electronic address: alessia.knauss@veoneer.com.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Dozza', 'Affiliation': 'Department of Mechanics and Maritime Sciences, Chalmers University of Technology, Hörselgången 4, 41756 Göteborg, Sweden. Electronic address: marco.dozza@chalmers.se.'}]",Accident; analysis and prevention,['10.1016/j.aap.2020.105569']
3040,32446280,Does performance-based financing curb stock-outs of essential medicines? Results from a randomised controlled trial in Cameroon.,"OBJECTIVE


In 2011, the government of Cameroon launched its performance-based financing (PBF) scheme. Our study examined the effects of the PBF intervention on the availability of essential medicines (EM).
METHODS


Randomised control trial whereby PBF and three distinct comparison groups were randomised in a total of 205 health facilities across three regions. Baseline data were collected between March and May 2012 and endline data 36 months later. We defined availability of multiple EM groups by assessing stock-outs for at least one day over the 30 days prior to the survey date and estimated changes attributable to PBF using a series of difference-in-difference regression models, adjusted for relevant facility-level covariates. Data were analysed stratified by region and area to assess effect heterogeneity.
RESULTS


Our estimates suggest that PBF intervention had no effect on the stock-outs of antenatal care drugs (P = 0.160), vaccines (P = 0.396), integrated management of childhood illness drugs (P = 0.681) and labour and delivery drugs (P = 0.589). However, the intervention was associated with a significant reduction of 34% in stock-outs of family planning medicines (P = 0.028). We observed effect heterogeneity across regions and areas, with significant decreases in stock-outs of family planning products in North-West region (P = 0.065) and in rural areas (P = 0.043).
CONCLUSIONS


The PBF intervention in Cameroon had limited effects on the reduction of EMs stock-outs. These poor results were likely the consequence of partial implementation failure, ranging from disruption and discontinuation of services to limited facility autonomy in managing decision-making and considerable delay in performance payment.",2020,"We observed effect heterogeneity across regions and areas, with significant decreases in stock-outs of family planning products in North-West region (p = 0.065) and in rural areas (p = 0.043).
",['205 health facilities across three regions'],"['PBF intervention', 'PBF']","['stock-outs of antenatal care drugs', 'stock-outs of family planning products']","[{'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0243097', 'cui_str': 'financing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0453908', 'cui_str': 'Stocking'}, {'cui': 'C0439787', 'cui_str': 'Out'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009861', 'cui_str': 'Family planning service'}]",,0.070051,"We observed effect heterogeneity across regions and areas, with significant decreases in stock-outs of family planning products in North-West region (p = 0.065) and in rural areas (p = 0.043).
","[{'ForeName': 'Isidore', 'Initials': 'I', 'LastName': 'Sieleunou', 'Affiliation': 'University of Montreal Public Health Research Institute, Montreal, QC, Canada.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'De Allegri', 'Affiliation': 'Heidelberg Institute of Global Health, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Roland Enok Bonong', 'Affiliation': 'School of Public Health, University of Montreal, Montreal, QC, Canada.'}, {'ForeName': 'Samiratou', 'Initials': 'S', 'LastName': 'Ouédraogo', 'Affiliation': 'Institut National de Santé Publique du Québec, Montréal, QC, Canada.'}, {'ForeName': 'Valéry', 'Initials': 'V', 'LastName': 'Ridde', 'Affiliation': 'School of Public Health, University of Montreal, Montreal, QC, Canada.'}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13447']
3041,32449530,Cranberries after pelvic floor surgery for urinary tract infection prophylaxis: A randomized controlled trial.,"AIMS


Urinary tract infection (UTI) is a common complication after pelvic floor surgery. Antibiotics as prophylaxis may reduce the prevalence of UTI's by 50%, but bacterial resistance may be a large disadvantage, necessitating the search for other possible prophylactic options. Recent research found a 50% reduction in the rate of UTI's with the use of cranberry capsules after elective gynecologic surgery, suggesting that cranberry capsules may serve as a good prophylaxis. The aim of this study was to assess whether perioperative cranberry prophylaxis reduces the risk of clinical overt UTI after elective pelvic floor surgery with indwelling catheter.
METHODS


We conducted a single-center randomized, double-blind, placebo-controlled trial. Women were given cranberry capsules twice daily or identical placebo for 6 weeks, starting the day before surgery. The main endpoint of the trial was the incidence of UTI within 6 weeks after surgery, defined as clinical diagnosis and treatment of UTI by the medical doctor. Analyses were performed with the intention to treat.
RESULTS


Two hundred ten participants were included, 105 in each arm. There was no significant difference in the prevalence of UTI between the cranberry arm (n = 13, 12.4%) and the placebo arm (n = 21, 20.0%; P = .13), but the prevalence in both arms was lower than anticipated.
CONCLUSIONS


This trial shows no beneficial effect of adequately dosed cranberry prophylaxis in women undergoing pelvic floor surgery, although such effect cannot be ruled out in settings with a higher prevalence of UTI's.",2020,"There was no significant difference in the prevalence of UTI between the cranberry arm (n = 13, 12.4%) and the placebo arm (n = 21, 20.0%; P = .13), but the prevalence in both arms was lower than anticipated.
","['after elective pelvic floor surgery with indwelling catheter', 'Two hundred ten participants were included, 105 in each arm', 'women undergoing pelvic floor surgery']","['cranberry prophylaxis', 'perioperative cranberry prophylaxis', 'cranberry capsules twice daily or identical placebo', 'Cranberries after pelvic floor surgery', 'placebo']","['prevalence of UTI', 'clinical diagnosis and treatment of UTI by the medical doctor', 'risk of clinical overt UTI']","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0007439', 'cui_str': 'In-Dwelling Catheters'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",210.0,0.623332,"There was no significant difference in the prevalence of UTI between the cranberry arm (n = 13, 12.4%) and the placebo arm (n = 21, 20.0%; P = .13), but the prevalence in both arms was lower than anticipated.
","[{'ForeName': 'Ellen S', 'Initials': 'ES', 'LastName': 'Mooren', 'Affiliation': 'Department of Obstetrics and Gynaecology, Ikazia Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Willem J', 'Initials': 'WJ', 'LastName': 'Liefers', 'Affiliation': 'Department of Hospital Pharmacy, Ikazia Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Jan W', 'Initials': 'JW', 'LastName': 'de Leeuw', 'Affiliation': 'Department of Obstetrics and Gynaecology, Ikazia Hospital, Rotterdam, The Netherlands.'}]",Neurourology and urodynamics,['10.1002/nau.24391']
3042,32449684,Effectiveness of Group Cognitive Behavioral Therapy and Exercise in the Management of Major Depressive Disorder: Protocol for a Pilot Randomized Controlled Trial.,"BACKGROUND


Despite evidence in scientific literature indicating the effectiveness of both cognitive behavioral therapy (CBT) and physical exercise in the management of major depressive disorder (MDD), few studies have directly compared them.
OBJECTIVE


This study aims to evaluate and compare the effectiveness of group CBT, physical exercise, and only wait-listing to receive treatment-as-usual (TAU) in the management of MDD. The investigators hypothesize that participants with MDD assigned to the group CBT or exercise arms of the study will achieve superior outcomes compared with participants wait-listed to receive TAU only.
METHODS


This prospective rater-blinded randomized controlled trial assesses the benefits of group CBT and exercise for participants with MDD. A total of 120 patients with MDD referred to addiction and mental health clinics in Edmonton, Canada, will be randomly assigned to one of the three equal-sized arms of the study to receive either weekly sessions of group CBT plus TAU, group exercise three times a week plus TAU, or only TAU for 14 weeks. Participants will be assessed at enrollment, 3 and 6 months post enrollment, midtreatment, and upon treatment completion for primary (functional and symptom variables) and secondary outcomes (service variables and health care utilization). In addition, participants in the intervention groups would be evaluated weekly with one functional measure. The data will be analyzed using repeated measures and effect size analyses, and correlational analyses will be completed between measures at each time point.
RESULTS


The study will be conducted in accordance with the Declaration of Helsinki (Hong Kong amendment) and Good Clinical Practice (Canadian guidelines). Written informed consent will be obtained from each subject. The study received ethical clearance from the Health Ethics Research Board of the University of Alberta on September 7, 2018 (Pro 00080975) and operational approval from the provincial health authority (Alberta Health Services 43638). As of October 13, 2019, we have enrolled 32 participants. The results will be disseminated at several levels, including patients, practitioners, academics, researchers, and health care organizations.
CONCLUSIONS


The results of the pilot trial may inform the implementation of a multicenter clinical trial and provide useful information for administrators and clinicians who are interested in incorporating group CBT and group exercise interventions into existing care.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03731728; https://clinicaltrials.gov/ct2/show/NCT03731728.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/14309.",2020,"The results of the pilot trial may inform the implementation of a multicenter clinical trial and provide useful information for administrators and clinicians who are interested in incorporating group CBT and group exercise interventions into existing care.
","['Major Depressive Disorder', '120 patients with MDD referred to addiction and mental health clinics in Edmonton, Canada', 'major depressive disorder (MDD', 'participants with MDD', 'accordance with the Declaration of Helsinki (Hong Kong amendment) and Good Clinical Practice (Canadian guidelines']","['CBT plus TAU, group exercise three times a week plus TAU, or only TAU', 'group CBT, physical exercise, and only wait-listing to receive treatment-as-usual (TAU', 'cognitive behavioral therapy (CBT) and physical exercise', 'CBT and exercise', 'Group Cognitive Behavioral Therapy and Exercise']",[],"[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C3839912', 'cui_str': 'Mental health clinic'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0018898', 'cui_str': 'Declaration of Helsinki'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]",[],120.0,0.114613,"The results of the pilot trial may inform the implementation of a multicenter clinical trial and provide useful information for administrators and clinicians who are interested in incorporating group CBT and group exercise interventions into existing care.
","[{'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Yekrang Safakar', 'Affiliation': 'Department of Psychiatry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Hrabok', 'Affiliation': 'Department of Psychiatry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Liana', 'Initials': 'L', 'LastName': 'Urichuk', 'Affiliation': 'Department of Psychiatry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Juhas', 'Affiliation': 'Department of Psychiatry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Reham', 'Initials': 'R', 'LastName': 'Shalaby', 'Affiliation': 'Department of Psychiatry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Devashree', 'Initials': 'D', 'LastName': 'Parmar', 'Affiliation': 'Addiction and Mental Health, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Chue', 'Affiliation': 'Department of Psychiatry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Snaterse', 'Affiliation': 'Addiction and Mental Health, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Mason', 'Affiliation': 'Addiction and Mental Health, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Tchida', 'Affiliation': 'Addiction and Mental Health, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Kelland', 'Affiliation': 'Addiction and Mental Health, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Coulson', 'Affiliation': 'Addiction and Mental Health, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Daniella', 'Initials': 'D', 'LastName': 'Sosdjan', 'Affiliation': 'Addiction and Mental Health, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'Addiction and Mental Health, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Hay', 'Affiliation': 'Addiction and Mental Health, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Deanna', 'Initials': 'D', 'LastName': 'Lesage', 'Affiliation': 'Addiction and Mental Health, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Lacey', 'Initials': 'L', 'LastName': 'Paulsen', 'Affiliation': 'Addiction and Mental Health, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Delday', 'Affiliation': 'Addiction and Mental Health, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Sherianna', 'Initials': 'S', 'LastName': 'Duiker', 'Affiliation': 'Addiction and Mental Health, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Shireen', 'Initials': 'S', 'LastName': 'Surood', 'Affiliation': 'Addiction and Mental Health, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Abba-Aji', 'Affiliation': 'Department of Psychiatry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Vincent Israel Opoku', 'Initials': 'VIO', 'LastName': 'Agyapong', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}]",JMIR research protocols,['10.2196/14309']
3043,32449690,Daily Self-Monitoring of Symptoms and Skills Learning in Patients With Borderline Personality Disorder Through a Mobile Phone App: Protocol for a Pragmatic Randomized Controlled Trial.,"BACKGROUND


Patient self-monitoring via mobile phones during psychotherapy can enhance and provide an overview of psychotherapeutic progress by graphically displaying current and previous symptom scores, providing feedback to the patient, delivering psychoeducative material, and providing timely data to the therapist or treatment team.
OBJECTIVE


This study will aim to assess the effects of using a mobile phone to self-monitor symptoms and acquire coping skills instead of using pen and paper during psychotherapy in patients with borderline personality disorder (BPD). Dialectical behavior therapy will be performed to treat BPD. The primary outcome is the mean time needed to learn coping skills directed at emotion regulation; the secondary outcome is changes in the BPD symptom score as measured by the Zanarini Rating Scale for Borderline Personality Disorder.
METHODS


This study is a pragmatic, multicenter randomized controlled trial. Participants were recruited through five public general psychiatric outpatient treatment facilities in Denmark. Patients are randomly assigned, on a 1:1 basis, to either the mobile phone condition (using the Monsenso mDiary mobile app) or pen-and-paper condition. Patients will complete several self-report questionnaires on symptom severity; assessments by trained raters on BPD severity will be performed as well. Survival analysis with a shared frailty model will be used to assess the primary outcome.
RESULTS


Recruitment began in June 2017 and was completed in February 2019 after 80 participants were recruited. The study ended in February 2020. It is expected that the benefits of mobile phone-based self-report compared to the pen-and-paper method will be demonstrated for skill learning speed and registration compliance. To our knowledge, this is the first trial exploring the impact of cloud-based mobile registration in BPD treatment.
CONCLUSIONS


This trial will report on the effectiveness of mobile phone-based self-monitoring during psychiatric treatment. It has the potential to contribute to evidence-based clinical practice since apps are already in use clinically.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03191565; https://clinicaltrials.gov/ct2/show/NCT03191565.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/17737.",2020,"OBJECTIVE


This study will aim to assess the effects of using a mobile phone to self-monitor symptoms and acquire coping skills instead of using pen and paper during psychotherapy in patients with borderline personality disorder (BPD).","['Participants were recruited through five public general psychiatric outpatient treatment facilities in Denmark', 'patients with borderline personality disorder (BPD', 'Recruitment began in June 2017 and was completed in February 2019 after 80 participants were recruited', 'Patients With Borderline Personality Disorder']","['mobile phone-based self-monitoring', 'Daily Self-Monitoring of Symptoms and Skills Learning', 'mobile phone condition (using the Monsenso mDiary mobile app) or pen-and-paper condition', 'mobile phone to self-monitor symptoms and acquire coping skills instead of using pen and paper during psychotherapy', 'Dialectical behavior therapy']",['mean time needed to learn coping skills directed at emotion regulation; the secondary outcome is changes in the BPD symptom score as measured by the Zanarini Rating Scale for Borderline Personality Disorder'],"[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C1564509', 'cui_str': 'Or-pen'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0070220', 'cui_str': 'penclomedine'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C1321145', 'cui_str': 'Dialectical behavior therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",80.0,0.257132,"OBJECTIVE


This study will aim to assess the effects of using a mobile phone to self-monitor symptoms and acquire coping skills instead of using pen and paper during psychotherapy in patients with borderline personality disorder (BPD).","[{'ForeName': 'Stig', 'Initials': 'S', 'LastName': 'Helweg-Jørgensen', 'Affiliation': 'Research Unit for Telepsychiatry and E-mental Health, Mental Health Services in the Region of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Beck Lichtenstein', 'Affiliation': 'Research Unit for Telepsychiatry and E-mental Health, Mental Health Services in the Region of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Alan E', 'Initials': 'AE', 'LastName': 'Fruzzetti', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Møller Dahl', 'Affiliation': 'Department of Business and Economics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Susanne S', 'Initials': 'SS', 'LastName': 'Pedersen', 'Affiliation': 'Institute of Psychology, University of Southern Denmark, Odense, Denmark.'}]",JMIR research protocols,['10.2196/17737']
3044,32561941,A randomized in vitro evaluation of transient and permanent cardiac implantable electronic device malfunctions following direct exposure up to 10 Gy.,"BACKGROUND AND PURPOSE


High-dose 6‑MV radiotherapy may cause cardiac implantable electronic devices (CIEDs) to malfunction. To assess CIED malfunctions resulting from direct exposure up to 10 Gy, 100 pacemakers (PMs) and 40 implantable cardioverter-defibrillators (ICDs) were evaluated.
MATERIALS AND METHODS


CIEDs underwent baseline interrogation. In ICDs, antitachycardia therapies were disabled via the programmer while the detection windows were left enabled. A computed tomography (CT) scan was performed to build the corresponding treatment plan. CIEDs were ""blinded"" and randomized to receive single doses of either 2, 5, or, 10 Gy via a 6-MV linear accelerator (linac) in a water phantom. Twenty-two wireless telemetry-enabled CIEDs underwent a real-time session, and their function was recorded by the video camera in the bunker. The CIEDs were interrogated after exposure and once monthly for 6 months.
RESULTS


During exposure, regardless of dose, 90.9% of the CIEDs recorded electromagnetic interference, with 6 ICDs (27.3%) reporting pacing inhibition and inappropriate arrhythmia detections. After exposure, a backup reset was observed in 1 PM (0.7% overall, 1% among PMs), while 7 PMs (5% overall, 7% among PMs) reported battery issues (overall immediate malfunction rate was 5.7%). During follow-up, 4 PMs (2.9% overall; 4% among PMs) and 1 ICD (0.7% overall; 2.5% among ICDs) reported abnormal battery depletion, and 1 PM (0.7% overall; 1% among PMs) reported a backup reset (overall late malfunction rate was 4.3%).
CONCLUSION


Apart from transient electromagnetic interference, last-generation CIEDs withstood direct 6‑MV exposure up to 10 Gy. Permanent battery or software errors occurred immediately or later only in less recent CIEDs.",2020,"During exposure, regardless of dose, 90.9% of the CIEDs recorded electromagnetic interference, with 6 ICDs (27.3%) reporting pacing inhibition and inappropriate arrhythmia detections.",[],"['A\xa0computed tomography (CT) scan', '6‑MV radiotherapy', 'transient and permanent cardiac implantable electronic device malfunctions']","['pacing inhibition and inappropriate arrhythmia detections', 'electromagnetic interference', 'Permanent battery or software errors', 'abnormal battery depletion']",[],"[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C1504465', 'cui_str': 'Device malfunction'}]","[{'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C1504600', 'cui_str': 'Electromagnetic interference'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}]",,0.0740967,"During exposure, regardless of dose, 90.9% of the CIEDs recorded electromagnetic interference, with 6 ICDs (27.3%) reporting pacing inhibition and inappropriate arrhythmia detections.","[{'ForeName': 'Maria Daniela', 'Initials': 'MD', 'LastName': 'Falco', 'Affiliation': 'Department of Radiation Oncology, ""SS. Annunziata"" Hospital, ""G. D\'Annunzio"" University, Via De\' Vestini, 66100, Chieti, Italy. mdanielafalco@hotmail.com.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Genovesi', 'Affiliation': 'Department of Radiation Oncology, ""SS. Annunziata"" Hospital, ""G. D\'Annunzio"" University, Via De\' Vestini, 66100, Chieti, Italy.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Caravatta', 'Affiliation': 'Department of Radiation Oncology, ""SS. Annunziata"" Hospital, ""G. D\'Annunzio"" University, Via De\' Vestini, 66100, Chieti, Italy.'}, {'ForeName': 'Clelia', 'Initials': 'C', 'LastName': 'Di Carlo', 'Affiliation': 'Department of Radiation Oncology, ""SS. Annunziata"" Hospital, ""G. D\'Annunzio"" University, Via De\' Vestini, 66100, Chieti, Italy.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Bliakharskaia', 'Affiliation': ""Department of Clinical Medicine, Public Health, Life and Environmental Sciences, University of L'Aquila, L'Aquila, Italy.""}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Appignani', 'Affiliation': 'Intensive Cardiac Care Unit, ""SS. Annunziata"" Hospital, Chieti, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Faustino', 'Affiliation': 'Arrhythmology Unit, ""SS. Annunziata"" Hospital, Chieti, Italy.'}, {'ForeName': 'Nanda', 'Initials': 'N', 'LastName': 'Furia', 'Affiliation': 'Arrhythmology Unit, ""SS. Annunziata"" Hospital, Chieti, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Di Girolamo', 'Affiliation': 'Arrhythmology Unit, ""SS. Annunziata"" Hospital, Chieti, Italy.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-020-01651-7']
3045,32561942,[A superoxide dismutase mimetic (GC4419) vs. placebo to reduce severe oral mucositis due to concurrent radiotherapy and cisplatin for head and neck cancer: a phase-IIb randomized double-blind study].,,2020,,['head and neck cancer'],"['superoxide dismutase mimetic (GC4419) vs. placebo', 'radiotherapy and cisplatin']",['severe oral mucositis'],"[{'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}]","[{'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}]",,0.573769,,"[{'ForeName': 'Irenäus A', 'Initials': 'IA', 'LastName': 'Adamietz', 'Affiliation': 'Klinik für Strahlentherapie und Radio-Onkologie, Marien Hospital Herne Universitätsklinik, Ruhr-Universität Bochum, Hölkeskampring\xa040, 44625, Herne, Deutschland. irenaeus.adamietz@elisabethgruppe.de.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-020-01639-3']
3046,32562195,Health-related quality of life and physical activity level after a behavior change program at Norwegian healthy life centers: a 15-month follow-up.,"PURPOSE


The long-term impact of primary care behavior change programs on health-related quality of life (HRQoL) and physical activity (PA) level is unknown. The aim of this study was to investigate changes in HRQoL and PA among participants after a 3-month behavior change intervention at Norwegian healthy life center (HLCs) and at a 15-month follow-up. Furthermore, we aimed to study associations between changes in PA and HRQoL.
METHODS


We followed 524 adult participants (18-83 years), recruited from 32 HLCs in August 2016-January 2018, who provided data on HRQoL (SF-36) and PA (ActiGraph accelerometers) 12 months after a 3-month behavior change intervention. Changes in HRQoL and PA between baseline, 3-month and 15-month follow-ups, and associations between changes in PA and HRQoL were analyzed by linear mixed models.
RESULTS


All HRQoL dimensions improved from baseline to 3-month follow-up, and the improvements maintained at 15-month follow-up (mean 3.1-13.1 points, p < 0.001). PA increased from baseline to 3 months (mean 418 steps/day, p < 0.001), but declined from 3 to 15 months (mean - 371 steps/day, p < 0.001). We observed positive associations between changes in PA and HRQoL (0.84-3.23 points per 1000 steps/day, p < 0.023).
CONCLUSIONS


Twelve months after completing a 3-month HLC intervention we found improved HRQoL, but not PA level. Still, there were positive associations between PA and HRQoL over this period, indicating that participants increasing their PA were more likely to improve their HRQoL.",2020,"PA increased from baseline to 3 months (mean 418 steps/day, p < 0.001), but declined from 3 to 15 months (mean - 371 steps/day, p < 0.001).","['524 adult participants (18-83\xa0years), recruited from 32 HLCs in August 2016-January 2018, who provided data on HRQoL (SF-36) and PA (ActiGraph accelerometers) 12\xa0months after a 3-month behavior change intervention', 'participants after a 3-month behavior change intervention at Norwegian healthy life center (HLCs) and at a 15-month follow-up', 'Norwegian healthy life centers']","['HRQoL', 'primary care behavior change programs']","['Health-related quality of life and physical activity level', 'HRQoL', 'PA', 'HRQoL and PA', 'All HRQoL dimensions', 'health-related quality of life (HRQoL) and physical activity (PA) level']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",524.0,0.0265546,"PA increased from baseline to 3 months (mean 418 steps/day, p < 0.001), but declined from 3 to 15 months (mean - 371 steps/day, p < 0.001).","[{'ForeName': 'Ellen Eimhjellen', 'Initials': 'EE', 'LastName': 'Blom', 'Affiliation': 'Department of Sport, Food and Natural Sciences, Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Campus Sogndal, Postbox 133, 6851, Sogndal, Norway. ellen.blom@hvl.no.'}, {'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Aadland', 'Affiliation': 'Department of Sport, Food and Natural Sciences, Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Campus Sogndal, Postbox 133, 6851, Sogndal, Norway.'}, {'ForeName': 'Guri Kaurstad', 'Initials': 'GK', 'LastName': 'Skrove', 'Affiliation': 'Department of Social Sciences, Møreforsking Molde AS, Britvegen 4, 6410, Molde, Norway.'}, {'ForeName': 'Ane Kristiansen', 'Initials': 'AK', 'LastName': 'Solbraa', 'Affiliation': 'Department of Sport, Food and Natural Sciences, Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Campus Sogndal, Postbox 133, 6851, Sogndal, Norway.'}, {'ForeName': 'Line Merethe', 'Initials': 'LM', 'LastName': 'Oldervoll', 'Affiliation': 'Department of Public Health and Nursing, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, 7491, Trondheim, Norway.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-020-02554-x']
3047,32562206,Dabigatran Dual Therapy vs Warfarin Triple Therapy Post-Percutaneous Coronary Intervention in Patients with Atrial Fibrillation With/Without a Proton Pump Inhibitor: A Pre-Specified Analysis of the RE-DUAL PCI Trial.,"BACKGROUND AND OBJECTIVE


In patients with atrial fibrillation following percutaneous coronary intervention, if a proton pump inhibitor is used, could that allow the use of warfarin triple therapy, or is there additional reduction in bleeding while using it with dual therapy?
METHODS


The RE-DUAL PCI trial randomized 2725 patients with atrial fibrillation post-percutaneous coronary intervention to dabigatran dual therapy (110 or 150 mg twice daily, with clopidogrel or ticagrelor) or warfarin triple therapy (with clopidogrel or ticagrelor, and aspirin for 1-3 months). This prespecified subgroup analysis evaluated risks of a first major bleeding event or clinically relevant non-major bleeding event, all gastrointestinal bleeding, and a composite efficacy endpoint of all-cause mortality/thromboembolic event or unplanned revascularization according to baseline use of a proton pump inhibitor.
RESULTS


Of 2678 analyzed patients, 1641 (61.3%) were receiving a proton pump inhibitor at baseline. Dabigatran 110 and 150 mg dual therapy reduced the risk of major bleeding events or clinically relevant non-major bleeding events vs warfarin triple therapy regardless of proton pump inhibitor use, with comparable risk of the composite efficacy endpoint (all interaction p values > 0.05). For gastrointestinal bleeding, no interaction was observed between study treatment and proton pump inhibitor use (interaction p values 0.84 and 0.62 for dabigatran 110 and 150 mg dual therapy, respectively, vs warfarin triple therapy).
CONCLUSIONS


Dabigatran 110 and 150 mg dual therapy reduced the risk of major bleeding events or clinically relevant non-major bleeding events vs warfarin triple therapy, regardless of proton pump inhibitor use at baseline, in patients with atrial fibrillation who underwent percutaneous coronary intervention. Risk of the composite efficacy endpoint appeared to be similar for dabigatran dual therapy vs warfarin triple therapy in patients receiving/not receiving a proton pump inhibitor. CLINICALTRIALS.
GOV UNIQUE IDENTIFIER


NCT02164864.",2020,"Dabigatran 110 and 150 mg dual therapy reduced the risk of major bleeding events or clinically relevant non-major bleeding events vs warfarin triple therapy regardless of proton pump inhibitor use, with comparable risk of the composite efficacy endpoint (all interaction p values > 0.05).","['patients with atrial fibrillation who underwent percutaneous coronary intervention', 'patients receiving/not receiving a proton pump inhibitor', 'Patients with Atrial Fibrillation', 'patients with atrial fibrillation following percutaneous coronary intervention', 'Of 2678 analyzed patients, 1641 (61.3%) were receiving a proton pump inhibitor at baseline', '2725 patients with atrial fibrillation post-percutaneous coronary intervention to']","['warfarin triple therapy', 'dabigatran dual therapy', 'Dabigatran', 'clopidogrel or ticagrelor', 'Proton Pump Inhibitor', 'warfarin triple therapy (with clopidogrel or ticagrelor, and aspirin', 'proton pump inhibitor', 'Dabigatran Dual Therapy vs Warfarin Triple Therapy Post-Percutaneous Coronary Intervention']","['risk of major bleeding events', 'risks of a first major bleeding event or clinically relevant non-major bleeding event, all gastrointestinal bleeding, and a composite efficacy endpoint of all-cause mortality/thromboembolic event or unplanned revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",2725.0,0.0706981,"Dabigatran 110 and 150 mg dual therapy reduced the risk of major bleeding events or clinically relevant non-major bleeding events vs warfarin triple therapy regardless of proton pump inhibitor use, with comparable risk of the composite efficacy endpoint (all interaction p values > 0.05).","[{'ForeName': 'José C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Enéas Carvalho Aguiar, 44, Sao Paulo, SP, 05403-000, Brazil. jose.nicolau@incor.usp.br.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital and Heart and Vascular Center, and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Stefan H', 'Initials': 'SH', 'LastName': 'Hohnloser', 'Affiliation': 'Johann Wolfgang Goethe University, Frankfurt am Main, Germany.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, UK.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Miede', 'Affiliation': 'Mainanalytics ma GmbH, Sulzbach (Taunus), Germany.'}, {'ForeName': 'Matias', 'Initials': 'M', 'LastName': 'Nordaby', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Oldgren', 'Affiliation': 'Uppsala Clinical Research Center, and Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Université de Paris, FACT, INSERM U_1148, Paris, France.'}, {'ForeName': 'Jurriën M', 'Initials': 'JM', 'LastName': 'Ten Berg', 'Affiliation': 'St. Antonius Ziekenhuis, Nieuwegein, the Netherlands.'}, {'ForeName': 'Lucas C', 'Initials': 'LC', 'LastName': 'Godoy', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Enéas Carvalho Aguiar, 44, Sao Paulo, SP, 05403-000, Brazil.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Brigham and Women's Hospital and Heart and Vascular Center, and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Drugs,['10.1007/s40265-020-01323-x']
3048,32562310,Impact of Phenol-Enriched Virgin Olive Oils on the Postprandial Levels of Circulating microRNAs Related to Cardiovascular Disease.,"SCOPE


We aimed to investigate the postprandial modulation of cardiovascular-related microRNAs elicited by Extra Virgin Olive oil (EVOOs) containing different levels of own polyphenols METHODS AND RESULTS: Randomized, postprandial, parallel, double-blind study. 12 healthy participants consumed 30 mL of EVOO containing Low (L-EVOO; 250 mg total phenols/kg of oil), Medium (M-EVOO; 500 mg total phenols/kg of oil) and high (H-EVOO; 750 mg total phenols/kg of oil) polyphenol content to 6 h. Plasma microRNAs levels were analysed by Real-Time quantitative PCR. The results show that L-EVOO intake was associated with decreased let-7e-5p and miR-328a-3p levels and increased miR-17-5p and miR-20a-5p, concentrations. M-EVOO decreased plasma let-7e-5p and increased miR-17-5p, miR-20a-5p and miR-192-5p levels. Finally, H-EVOO decreased let-7e-5p, miR-10a-5p, miR-21-5p and miR-26b-5p levels.
CONCLUSIONS


During the postprandial state, the levels of let-7e-5p decreased with EVOO regardless of polyphenol content suggesting a general response to the fatty acid composition of EVOO or/and the presence of at least 250 mg polyphenol/kg olive oil. Moreover, the miR-17-92 cluster increased by low and medium polyphenol content suggesting a role in fatty acid metabolism and nutrient sensing. Thus, modulation of circulating microRNAs levels could be a potential mechanism for the cardiovascular benefits associated with EVOO intake. This article is protected by copyright. All rights reserved.",2020,"M-EVOO decreased plasma let-7e-5p and increased miR-17-5p, miR-20a-5p and miR-192-5p levels.",['12 healthy participants'],"['consumed 30\xa0mL of EVOO containing Low (L-EVOO; 250\xa0mg total phenols/kg of oil), Medium (M-EVOO; 500\xa0mg total phenols/kg of oil) and high (H-EVOO; 750\xa0mg total phenols/kg of oil) polyphenol', 'Extra Virgin Olive oil (EVOOs', 'Phenol-Enriched Virgin Olive Oils', 'polyphenol/kg olive oil']","['let-7e-5p and miR-328a-3p levels and increased miR-17-5p and miR-20a-5p, concentrations', 'Plasma microRNAs levels', 'L-EVOO intake', 'H-EVOO decreased let-7e-5p, miR-10a-5p, miR-21-5p and miR-26b-5p levels', 'M-EVOO decreased plasma let-7e-5p and increased miR-17-5p, miR-20a-5p and miR-192-5p levels']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031428', 'cui_str': 'Phenols'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}]","[{'cui': 'C0086562', 'cui_str': 'Energy Transfer, Linear'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C4517623', 'cui_str': '192'}]",12.0,0.125285,"M-EVOO decreased plasma let-7e-5p and increased miR-17-5p, miR-20a-5p and miR-192-5p levels.","[{'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Daimiel', 'Affiliation': 'Nutritional Control of the Epigenome Group. Instituto Madrileño de Estudios Avanzados (IMDEA) Food Institute, CEI UAM+CSIC, Madrid, Spain.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Micó', 'Affiliation': 'Nutritional Control of the Epigenome Group. Instituto Madrileño de Estudios Avanzados (IMDEA) Food Institute, CEI UAM+CSIC, Madrid, Spain.'}, {'ForeName': 'Rosa M', 'Initials': 'RM', 'LastName': 'Valls', 'Affiliation': 'Functional Nutrition, Oxidation and Cardiovascular Disease Research Group. Universitat Rovira i Virgili, Hospital Universitari Sant Joan, EURECAT, Reus, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Pedret', 'Affiliation': 'Functional Nutrition, Oxidation and Cardiovascular Disease Research Group. Universitat Rovira i Virgili, Hospital Universitari Sant Joan, EURECAT, Reus, Spain.'}, {'ForeName': 'M José', 'Initials': 'MJ', 'LastName': 'Motilva', 'Affiliation': ""Food Technology Department, Agrotecnio Center, Escola Tècnica Superior d'Enginyeria Agrària, University of Lleida, Lleida, Spain.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Rubió', 'Affiliation': ""Food Technology Department, Agrotecnio Center, Escola Tècnica Superior d'Enginyeria Agrària, University of Lleida, Lleida, Spain.""}, {'ForeName': 'Montse', 'Initials': 'M', 'LastName': 'Fitó', 'Affiliation': 'Cardiovascular Risk and Nutrition (Regicor Study Group), Hospital del Mar Medical Research Institute (IMIM), Barcelona, Spain. CIBER de Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Farrás', 'Affiliation': 'Cardiovascular Risk and Nutrition (Regicor Study Group), Hospital del Mar Medical Research Institute (IMIM), Barcelona, Spain. CIBER de Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'María-Isabel', 'Initials': 'MI', 'LastName': 'Covas', 'Affiliation': 'Cardiovascular Risk and Nutrition (Regicor Study Group), Hospital del Mar Medical Research Institute (IMIM), Barcelona, Spain. CIBER de Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Solá', 'Affiliation': 'Functional Nutrition, Oxidation and Cardiovascular Disease Research Group. Universitat Rovira i Virgili, Hospital Universitari Sant Joan, EURECAT, Reus, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Ordovás', 'Affiliation': 'Nutritional Genomics and Epigenomics Group. Instituto Madrileño de Estudios Avanzados (IMDEA) Food Institute, CEI UAM+CSIC, Madrid, Spain.'}]",Molecular nutrition & food research,['10.1002/mnfr.202000049']
3049,32562337,Micro-needling versus fractional carbon dioxide laser for delivery of tranexamic acid in the treatment of melasma: A split-face study.,"BACKGROUND


Tranexamic acid (TXA) in oral, topical, and intra-dermal injection routes showed efficacy in melasma treatment. Micro-needling and fractional carbon dioxide (CO 2  ) laser were reported to enhance the drug delivery of TXA.
AIMS


This study aimed at comparing the use of micro-needling and fractional CO 2  laser for drug delivery of TXA in the treatment of facial melasma.
PATIENTS/METHODS


Thirty female patients with bilateral symmetrical facial melasma were subjected to micro-needling, for one side of the face, and fractional CO 2  laser, for the other, followed by an immediate topical application of TXA solution 4 mg/mL. Patients received six biweekly sessions.
RESULTS


Two weeks after the last session, a significant reduction in baseline modified melasma area and severity index (mMASI) score was observed on both sides. The mean ± SD baseline mMASI dropped from 3.43 ± 1.84 to 1.59 ± 1.51 (mean reduction 57.73%, P < .001) and from 3.51 ± 1.84 to 1.78 ± 1.51 (mean reduction 55.82%, P < .001) in the micro-needling-treated side and in the fractional CO 2  laser-treated side, respectively. However, no statistically significant differences were found between the two sides (P = .81).
CONCLUSIONS


Micro-needling and fractional CO 2  laser are equally safe and effective for the delivery of TXA in the treatment of facial melasma.",2020,"< .001) in the micro-needling-treated side and in the fractional CO 2  laser-treated side, respectively.","['Thirty female patients with bilateral symmetrical facial melasma', 'melasma', 'facial melasma']","['TXA', 'micro-needling and fractional CO 2  laser', 'Micro-needling and fractional carbon dioxide (CO 2  ) laser', 'TXA solution 4', 'Micro-needling versus fractional carbon dioxide laser', 'Tranexamic acid (TXA', 'tranexamic acid']","['baseline modified melasma area and severity index (mMASI) score', 'mean\xa0±\xa0SD baseline mMASI']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",30.0,0.0268775,"< .001) in the micro-needling-treated side and in the fractional CO 2  laser-treated side, respectively.","[{'ForeName': 'Khaled M M', 'Initials': 'KMM', 'LastName': 'Mekawy', 'Affiliation': 'Laser Unit, Department of Dermatology, Venereology and Andrology, Al-Azhar University Faculty of Medicine, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Sadek', 'Affiliation': 'Laser Unit, Department of Dermatology, Venereology and Andrology, Al-Azhar University Faculty of Medicine, Cairo, Egypt.'}, {'ForeName': 'Ahmad K', 'Initials': 'AK', 'LastName': 'Seddeik Abdel-Hameed', 'Affiliation': 'Laser Unit, Department of Dermatology, Venereology and Andrology, Al-Azhar University Faculty of Medicine, Cairo, Egypt.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13537']
3050,32562376,"Effect of the FreeStyle Libre TM  Flash Glucose Monitoring System on Glycemic Control in Subjects with Type 2 Diabetes Treated with Basal-Bolus Insulin Therapy: An Open Label, Prospective, Multicenter Trial in Japan.","AIMS/INTRODUCTION


We investigated the effect of FreeStyle Libre TM  on glycemic control in Japanese type 2 diabetes subjects treated with basal-bolus insulin therapy.
MATERIALS AND METHODS


This prospective, 90-day single-arm study enrolled 94 adults with type 2 diabetes treated with insulin. A 14-day masked baseline phase was followed by an 11-week treatment phase during which participants used the device to monitor glucose levels. Primary endpoint was time spent in hypoglycemia (<70 mg/dL) for baseline versus study end (days 76-90). Secondary endpoints included other measures of glycemic control, along with patient satisfaction using the Japanese Diabetes Treatment and Satisfaction Questionnaire (DTSQ).
RESULTS


Time spent in hypoglycemia was low at baseline (0.51 ± 0.93 hours/day, [mean ± SD]) and did not significantly decrease at study end (0.47 ± 0.63 hours/day, p=0.6354). Time in range, time in hyperglycemia and estimated A1c all improved vs. baseline (by +1.7 ± 3.0 hours/day, -1.6 ± .4 hours/day and -0.4 ± 0.8% respectively, p<0.0001 in each). Finger stick tests fell from 2.9 ± 1.3 to 1.9 ± 1.4/day, and mean scanning frequency during the intervention phase was 11.3/day. Mean treatment satisfaction score increased by 11.8 ± 5.3 (p<0.0001). Two severe hypoglycemia-related adverse events were reported; one of which was possibly related to the device. Three participants reported mild device-related skin trauma, site discomfort or subcutaneous bleeding.
CONCLUSIONS


Use of FreeStyle Libre in Japanese type 2 diabetes treated with basal-bolus insulin therapy revealed a low baseline of hypoglycemia and enabled improved glycemic control and treatment satisfaction.",2020,Mean treatment satisfaction score increased by 11.8 ± 5.3 (p<0.0001).,"['Japanese type 2 diabetes subjects treated with basal-bolus insulin therapy', '94 adults with type 2 diabetes treated with insulin', 'Subjects with Type 2 Diabetes Treated with Basal-Bolus Insulin Therapy']","['FreeStyle Libre TM', 'FreeStyle Libre TM  Flash Glucose Monitoring System', 'FreeStyle Libre']","['severe hypoglycemia-related adverse events', 'measures of glycemic control, along with patient satisfaction using the Japanese Diabetes Treatment and Satisfaction Questionnaire (DTSQ', 'mean scanning frequency', 'glycemic control and treatment satisfaction', 'mild device-related skin trauma, site discomfort or subcutaneous bleeding', 'Time spent in hypoglycemia', 'Mean treatment satisfaction score', 'Time in range, time in hyperglycemia', 'glycemic control', 'time spent in hypoglycemia']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C2750515', 'cui_str': 'Subcutaneous bleeding'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",94.0,0.0575329,Mean treatment satisfaction score increased by 11.8 ± 5.3 (p<0.0001).,"[{'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Ogawa', 'Affiliation': 'Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Yushi', 'Initials': 'Y', 'LastName': 'Hirota', 'Affiliation': 'Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Osonoi', 'Affiliation': 'Nakakinen Clinic, Ibaraki, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Tosaki', 'Affiliation': 'TDE Healthcare Corporation, TOSAKI Clinic for Diabetes and Endocrinology, Aichi, Japan.'}, {'ForeName': 'Yoshiro', 'Initials': 'Y', 'LastName': 'Kato', 'Affiliation': 'Aichi Medical University School of Medicine, Aichi, Japan.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Utsunomiya', 'Affiliation': 'The Jikei Medical University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Rimei', 'Initials': 'R', 'LastName': 'Nishimura', 'Affiliation': 'The Jikei Medical University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Jiro', 'Initials': 'J', 'LastName': 'Nakamura', 'Affiliation': 'Aichi Medical University School of Medicine, Aichi, Japan.'}]",Journal of diabetes investigation,['10.1111/jdi.13327']
3051,32562395,Effect of Rehydration With Normal Saline Versus Ringer Lactate on Serum Sodium Level of Children With Acute Diarrhea and Severe Dehydration: A Randomized Controlled Trial.,"OBJECTIVE


To demonstrate the equivalence of Normal Saline (NS) and Ringer Lactate (RL) for change in serum sodium levels during correction of severe dehydration in children with acute diarrhea based on World Health Organization (WHO) plan C.
DESIGN


Equivalence randomized control trial.
SETTING


Pediatric diarrhea unit of a tertiary care hospital from May, 2016 to April, 2017.
PARTICIPANTS


72 children of 1-12 years with acute diarrhea and severe dehydration were enrolled. Children with dysentery, severe acute malnutrition, severe anemia, meningitis, and known surgical and systemic diseases were excluded.
INTERVENTION


RL (n=36) or NS (n=36) were used as per WHO plan C. Blood samples were drawn before intravenous fluid correction and 3 h post-intervention.
OUTCOME MEASURES


Mean change in serum sodium level from the baseline between the RL and NS groups.
RESULTS


70 children (35 in each group) completed the study. The difference in mean serum sodium levels from baseline in RL and NS groups were 1.4 (4.5) mEq/L and 2.1(4.9) mEq/L, respectively (P=0.58).
CONCLUSION


Both RL and NS are equivalent in terms of change in serum sodium from baseline for intravenous rehydration in children with acute diarrhea and severe dehydration.",2020,Both RL and NS are equivalent in terms of change in serum sodium from baseline for intravenous rehydration in children with acute diarrhea and severe dehydration.,"['Pediatric diarrhea unit of a tertiary care hospital from May, 2016 to April, 2017', 'Children With Acute Diarrhea and Severe Dehydration', 'children with acute diarrhea based on World Health Organization (WHO) plan C', '70 children (35 in each group) completed the study', 'children with acute diarrhea and severe dehydration', '72 children of 1-12 years with acute diarrhea and severe dehydration were enrolled', 'Children with dysentery, severe acute malnutrition, severe anemia, meningitis, and known surgical and systemic diseases were excluded']","['Normal Saline (NS) and Ringer Lactate (RL', 'Rehydration With Normal Saline Versus Ringer Lactate']","['Serum Sodium Level', 'Mean change in serum sodium level', 'mean serum sodium levels']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea'}, {'cui': 'C3472181', 'cui_str': 'Severe dehydration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013369', 'cui_str': 'Infectious diarrheal disease'}, {'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0025289', 'cui_str': 'Meningitis'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0442893', 'cui_str': 'Systemic disease'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0073385', 'cui_str': ""Lactated Ringer's Solution""}, {'cui': 'C0034997', 'cui_str': 'Rehydration therapy'}]","[{'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",70.0,0.186479,Both RL and NS are equivalent in terms of change in serum sodium from baseline for intravenous rehydration in children with acute diarrhea and severe dehydration.,"[{'ForeName': 'Md', 'Initials': 'M', 'LastName': 'Naseem', 'Affiliation': 'Department of Pediatrics, Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi, India.'}, {'ForeName': 'A P', 'Initials': 'AP', 'LastName': 'Dubey', 'Affiliation': 'Department of Pediatrics, Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi, India.'}, {'ForeName': 'T K', 'Initials': 'TK', 'LastName': 'Mishra', 'Affiliation': 'Department of Biochemistry, Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi, India.'}, {'ForeName': 'Raghvendra', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Department of Pediatrics, Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi, India. Correspondence to: Dr Raghvendra Singh, Associate Professor, Department of Pediatrics, Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi, India. drraghvendrasingh@gmail.com.'}]",Indian pediatrics,[]
3052,32562433,Effects of Illness Representation-Focused Patient Education on Illness Representations and Self-care in Patients with Heart Failure: A Randomized Clinical Trial.,"AIMS AND OBJECTIVES


To examine the effect of an illness representation-focused patient education intervention on illness representations and self-care behaviours in patients with heart failure three months after discharge from the hospital.
BACKGROUND


Few intervention studies have examined the effect of illness representation-focused interventions on illness representations and self-care in patients with heart failure.
DESIGN


A randomized clinical trial based on the Consolidated Standard of Reporting Trials -CONSORT 2010 guidelines was employed. The Clinical Trial Registry number is TCTR20190903002.
METHODS


One hundred seven participants were randomly assigned to 2 groups, and 62 participants (n = 30 in the intervention group and n = 32 in the usual care group) completed the baseline and one- and three-month post-discharge follow-up assessments. The instruments included the Survey of Illness Beliefs in Heart Failure and the Self-care of Heart Failure Index. The intervention group received illness representation-focused patient education while hospitalized and telephone follow-ups after discharge. Data were analysed with linear mixed-effects model analysis.
RESULTS


The 107 participants had a mean age of 62.17 years and a mean left ventricular ejection of 53.03%. At baseline, the two groups tended to have accurate illness beliefs but insufficient self-care confidence and self-care maintenance. The analysis showed no significant differences between groups in the illness representation total scores, dimension scores or self-care maintenance scores but did show a significant difference in the self-care confidence scores (F = 3.42, p < .05) over the three months.
CONCLUSION


The study did not show an effect of the intervention on illness representations or self-care maintenance behaviours. However, the intervention did maintain participants' self-care confidence three months after discharge.
RELEVANCE TO CLINICAL PRACTICE


It is necessary to conduct long-term follow-ups of patients' illness representations, discuss the implementation of self-care behaviours with patients, enhance patients' self-care confidence, and involve family members or caregivers in self-care practices when needed.",2020,"The analysis showed no significant differences between groups in the illness representation total scores, dimension scores or self-care maintenance scores but did show a significant difference in the self-care confidence scores (F = 3.42, p < .05) over the three months.
","['patients with heart failure three months after discharge from the hospital', '107 participants had a mean age of 62.17 years and a mean left ventricular ejection of 53.03', 'One hundred seven participants were randomly assigned to 2 groups, and 62 participants (n = 30 in the intervention group and n = 32 in the', 'Patients with Heart Failure', 'patients with heart failure']","['illness representation-focused patient education intervention', 'Illness Representation-Focused Patient Education', 'illness representation-focused patient education while hospitalized and telephone follow-ups after discharge', 'usual care group) completed the baseline and one- and three-month post-discharge follow-up assessments']","['illness representations or self-care maintenance behaviours', 'illness representations and self-care behaviours', 'illness representation total scores, dimension scores or self-care maintenance scores', 'Survey of Illness Beliefs in Heart Failure and the Self-care of Heart Failure Index', 'Illness Representations and Self-care', 'self-care confidence scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2733342', 'cui_str': 'Left ventricular ejection'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C1320368', 'cui_str': 'Post-discharge follow-up'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",107.0,0.121429,"The analysis showed no significant differences between groups in the illness representation total scores, dimension scores or self-care maintenance scores but did show a significant difference in the self-care confidence scores (F = 3.42, p < .05) over the three months.
","[{'ForeName': 'Wan-Tzu', 'Initials': 'WT', 'LastName': 'Chang', 'Affiliation': 'Department of Nursing, National Cheng Kung University Hospital, Taiwan.'}, {'ForeName': 'Shan-Tair', 'Initials': 'ST', 'LastName': 'Wang', 'Affiliation': 'Ditmanson Medical Foundation Chiayi Christian Hospital, Chiayi City, Taiwan.'}, {'ForeName': 'Chi-Hsin', 'Initials': 'CH', 'LastName': 'Hsu', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Liang-Miin', 'Initials': 'LM', 'LastName': 'Tsai', 'Affiliation': 'Department of Internal Medicine, Tainan Municipal Hospital, Tainan, Taiwan.'}, {'ForeName': 'Shih-Hung', 'Initials': 'SH', 'LastName': 'Chan', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Hsing-Mei', 'Initials': 'HM', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}]",Journal of clinical nursing,['10.1111/jocn.15384']
3053,32562440,Evaluation and improvement of blood donor educational materials: results from a multicenter randomized controlled trial.,"BACKGROUND


Blood collection centers are charged with creating donor educational materials (DnEM) that are easily understood across all prospective donor populations, while addressing mandates and recommendations from regulatory agencies and professional standard setting organizations. Donors must have sufficient information to understand the donation process with its risks and benefits, time to consider options before deciding, and opportunity to choose whether to proceed with or decline donating. The goal of this multisite randomized controlled trial was to evaluate knowledge acquired using standardized DnEM. America's Blood Centers' Working Group (WG) for Donor Education and Communication was formed to evaluate and suggest modifications of these documents. Based on pilot work, a randomized clinical trial was designed to test donor knowledge across a variety of populations. The WG identified several shortcomings in the current DnEM and proposed new DnEM. The new DnEM were tested against the same, current DnEM being used at all three sites (Blood Donor Educational Material, 2016 version 2.0, published in conjunction with the AABB uniform donor history questionnaire).
METHODS AND MATERIALS


One-hundred sixty-five first time and returning donors were randomized in a 2x2 model to review either new DnEM or current DnEM. Every participant completed a pre- and post-quiz that tested their understanding of the DnEM.
RESULTS


Returning donors had greater baseline knowledge compared to new donors, but new donors improved more versus returning donors. Donors using the new DnEM showed greater improvement in knowledge than those using current DnEM.
CONCLUSION


Comprehension of DnEM can be improved. With this sample size the results suggest that the findings are independent of demographic characteristics, but a larger study would be necessary to confirm this.",2020,"Donors using the new DnEM showed greater improvement in knowledge than those using current DnEM.
",['One-hundred sixty-five first time and returning donors'],['new DnEM or current DnEM'],['blood donor educational materials'],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0013018', 'cui_str': 'Donors'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0521116', 'cui_str': 'Current'}]","[{'cui': 'C0005795', 'cui_str': 'Blood donor'}, {'cui': 'C0520510', 'cui_str': 'Material'}]",,0.0582905,"Donors using the new DnEM showed greater improvement in knowledge than those using current DnEM.
","[{'ForeName': 'Gay', 'Initials': 'G', 'LastName': 'Wehrli', 'Affiliation': 'University of Virginia Health, Charlottesville, Virginia, USA.'}, {'ForeName': 'Susan N', 'Initials': 'SN', 'LastName': 'Rossmann', 'Affiliation': 'Gulf Coast Regional Blood Center, Houston, Texas, USA.'}, {'ForeName': 'Dan A', 'Initials': 'DA', 'LastName': 'Waxman', 'Affiliation': 'Versiti, Indianapolis, Indiana, USA.'}, {'ForeName': 'Louis M', 'Initials': 'LM', 'LastName': 'Katz', 'Affiliation': 'Mississippi Valley Regional Blood Center, Davenport, Iowa, USA.'}]",Transfusion,['10.1111/trf.15866']
3054,32562498,Utilizing registry data to identify children with cerebral palsy previously enrolled in the magnesium sulfate randomized clinical trial.,,2020,,['children with cerebral palsy previously enrolled in the'],['magnesium sulfate'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}]","[{'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}]",[],,0.0847808,,"[{'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Adams-Chapman', 'Affiliation': ""Department of Pediatrics, Division of Neonatology, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, Georgia, USA.""}]",Developmental medicine and child neurology,['10.1111/dmcn.14600']
3055,32563188,"GnRH agonist and hCG (dual trigger) versus hCG trigger for final follicular maturation: a double-blinded, randomized controlled study.","STUDY QUESTION


Does co-administration of GnRH agonist and Human chorionic gonadotropin (hCG; dual trigger) in IVF cycles improve the number of mature oocytes and pregnancy outcome compared to hCG alone?
SUMMARY ANSWER


Using the dual trigger for final follicular maturation increases the number of oocytes, mature oocytes and number of blastocysts (total and top-quality) compared to triggering with hCG alone.
WHAT IS KNOWN ALREADY


hCG is used at the end of controlled ovarian hyperstimulation as a surrogate LH surge to induce final oocyte maturation. Recently, based on retrospective studies, the co-administration of GnRH agonist and hCG for final oocyte maturation (dual trigger) has been suggested to improve IVF outcome and pregnancy rates.
STUDY DESIGN, SIZE, DURATION


A single center, randomized controlled, double-blinded clinical trial between May 2016 and June 2018 analyzed by intention to treat (ITT).
PARTICIPANTS/MATERIALS, SETTINGS, METHODS


One hundred and fifty-five normal responder patients were randomized either to receive hCG or dual trigger for final oocyte maturation. Data on patients age, BMI, AMH, number of oocytes retrieved, number of metaphase 2 (MII) oocytes, zygotes and blastocysts, clinical pregnancy rate and live birth rate were assessed and compared between the dual trigger group and the hCG group. We performed a planned interim analysis after the recruitment of 50% of the patients. Based on the totality of outcomes at the interim analysis we decided to discontinue further recruitment.
MAIN RESULTS AND THE ROLE OF CHANCE


One hundred and fifty-five patients were included in the study. The age (36 years versus 35.3 years P = NS), BMI (24 kg/m2 versus 23.7 kg/m2) and the AMH (20.1 pmol/l versus 22.4 pmol/l) were comparable between the two groups. Based on ITT analysis, the number of eggs retrieved (11.1 versus 13.4, P = 0.002), the MII oocytes (8.6 versus 10.3, P = 0.009), total number of blastocysts (2.9 versus 3.9, P = 0.01) and top-quality blastocysts transferred (44.7% versus 64.9%; P = 0.003) were significantly higher in the dual trigger group compared to the hCG group. The clinical pregnancy rate (24.3% versus 46.1%, OR 2.65 (1.43-1.93), P = 0.009) and the live birth rate per transfer (22% versus 36.2%, OR= 1.98 (1.05-3.75), P = 0.03) were significantly higher in the dual trigger group compared to the hCG group.
LIMITATIONS, REASONS FOR CAUTION


None.
WIDER IMPLICATIONS OF THE FINDINGS


The enhanced response observed with the dual trigger might lead to better IVF outcomes were it used more widely.
STUDY FUNDING/COMPETING INTEREST(S)


The study was funded by TRIO Fertility. There are no conflicts of interest to declare.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov identifier: NCT02703584.
DATE OF TRIAL REGISTRATION


March 2016.
DATE OF FIRST PATIENT'S ENROLLMENT


May 2016.",2020,"Based on ITT analysis, the number of eggs retrieved (11.1 versus 13.4, P = 0.002), the MII oocytes (8.6 versus 10.3, P = 0.009), total number of blastocysts (2.9 versus 3.9, P = 0.01) and top-quality blastocysts transferred (44.7% versus 64.9%; P = 0.003) were significantly higher in the dual trigger group compared to the hCG group.","['One hundred and fifty-five normal responder patients', 'One hundred and fifty-five patients were included in the study', 'May 2016 and June 2018 analyzed by intention to treat (ITT', 'The age (36 years versus 35.3 years P = NS), BMI (24 kg/m2 versus 23.7 kg/m2) and the AMH (20.1 pmol/l versus 22.4 pmol/l']","['GnRH agonist and Human chorionic gonadotropin (hCG', 'hCG', 'GnRH agonist and hCG (dual trigger) versus hCG', 'GnRH agonist and hCG']","['number of oocytes, mature oocytes and number of blastocysts (total and top-quality', 'total number of blastocysts', 'clinical pregnancy rate', 'BMI, AMH, number of oocytes retrieved, number of metaphase 2 (MII) oocytes, zygotes and blastocysts, clinical pregnancy rate and live birth rate', 'IVF outcome and pregnancy rates', 'live birth rate per transfer', 'MII oocytes']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0162874', 'cui_str': 'Amharic language'}, {'cui': 'C0439284', 'cui_str': 'pmol/L'}]","[{'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}]","[{'cui': 'C0449803', 'cui_str': 'Number of oocytes'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1281743', 'cui_str': 'Blastocyst structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0162874', 'cui_str': 'Amharic language'}, {'cui': 'C1621812', 'cui_str': 'Metaphase'}, {'cui': 'C0043544', 'cui_str': 'Structure of zygote'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}]",155.0,0.308413,"Based on ITT analysis, the number of eggs retrieved (11.1 versus 13.4, P = 0.002), the MII oocytes (8.6 versus 10.3, P = 0.009), total number of blastocysts (2.9 versus 3.9, P = 0.01) and top-quality blastocysts transferred (44.7% versus 64.9%; P = 0.003) were significantly higher in the dual trigger group compared to the hCG group.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Haas', 'Affiliation': 'TRIO Fertility, Toronto, ON, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bassil', 'Affiliation': 'TRIO Fertility, Toronto, ON, Canada.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Samara', 'Affiliation': 'TRIO Fertility, Toronto, ON, Canada.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Zilberberg', 'Affiliation': 'TRIO Fertility, Toronto, ON, Canada.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mehta', 'Affiliation': 'TRIO Fertility, Toronto, ON, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Orvieto', 'Affiliation': 'IVF Unit, Department of Obstetrics and Gynecology, Chaim Sheba Medical Center, Tel-Hashomer, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'R F', 'Initials': 'RF', 'LastName': 'Casper', 'Affiliation': 'TRIO Fertility, Toronto, ON, Canada.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa107']
3056,32562573,"Genetic variation in PEAR1, cardiovascular outcomes and effects of aspirin in a healthy elderly population.","The platelet endothelial aggregation receptor-1 (PEAR1) rs12041331 variant has been identified as a genetic determinant of platelet aggregation in response to antiplatelet therapies, including aspirin. However, association with atherothrombotic cardiovascular events is less clear, with limited evidence from large trials. Here, we tested association of rs12041331 with cardiovascular events and aspirin use in a randomized trial population of healthy older individuals. We undertook post-hoc analysis of N=13,547 participants of the ASPirin in Reducing Events in the Elderly (ASPREE) trial, median age 74 years. Participants had no previous diagnosis of atherothrombotic cardiovascular disease at enrolment, and were randomized to either 100 mg daily low-dose aspirin or placebo for median 4.7 years follow-up. We used Cox proportional hazard regression to model the relationship between rs12041331 and the ASPREE primary cardiovascular disease endpoint (CVD), and composites of major adverse cardiovascular events (MACE) and ischaemic stroke (STROKE); and bleeding events; major hemorrhage (MHEM) and intracranial bleeding (ICB). We performed whole-population analysis using additive and dominant inheritance models, then stratified by treatment group. Interaction effects between genotypes and treatment group were examined. We observed no statistically significant association (P<0.05) in the population, or by treatment group, between rs12041331 and cardiovascular or bleeding events in either model. We also found no significant interaction effects between rs12041331-A and treatment group, for CVD (P=0.65), MACE (P=0.32), STROKE (P=0.56), MHEM (P=0.59) or ICB (P=0.56). The genetic variant PEAR1 rs12041331 is not associated with cardiovascular events in response to low-dose aspirin in a healthy elderly population.",2020,The genetic variant PEAR1 rs12041331 is not associated with cardiovascular events in response to low-dose aspirin in a healthy elderly population.,"['healthy older individuals', 'Participants had no previous diagnosis of atherothrombotic cardiovascular disease at enrolment', 'healthy elderly population', 'N=13,547 participants of the ASPirin in Reducing Events in the Elderly (ASPREE) trial, median age 74 years']","['aspirin', 'aspirin or placebo']","['cardiovascular disease endpoint (CVD), and composites of major adverse cardiovascular events (MACE) and ischaemic stroke (STROKE); and bleeding events; major hemorrhage (MHEM) and intracranial bleeding (ICB', 'Interaction effects', 'rs12041331 and cardiovascular or bleeding events']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332132', 'cui_str': 'Prior diagnosis'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}]",13547.0,0.0373115,The genetic variant PEAR1 rs12041331 is not associated with cardiovascular events in response to low-dose aspirin in a healthy elderly population.,"[{'ForeName': 'Joshua P', 'Initials': 'JP', 'LastName': 'Lewis', 'Affiliation': 'Department of Medicine, Program for Personalized and Genomic Medicine, University of Maryland School of Medicine, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Moeen', 'Initials': 'M', 'LastName': 'Riaz', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Xie', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Polekhina', 'Affiliation': 'Department of Medicine, Program for Personalized and Genomic Medicine, University of Maryland School of Medicine, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Nelson', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Tonkin', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Murray', 'Affiliation': 'Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare, Minneapolis, MN, USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McNeil', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Alan R', 'Initials': 'AR', 'LastName': 'Shuldiner', 'Affiliation': 'Department of Medicine, Program for Personalized and Genomic Medicine, University of Maryland School of Medicine, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lacaze', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1959']
3057,32562632,Long-term developmental effect of withholding parenteral nutrition in paediatric intensive care units: a 4-year follow-up of the PEPaNIC randomised controlled trial.,"BACKGROUND


The PEPaNIC randomised controlled trial, which recruited 1440 critically ill infants and children in 2012-15, showed that withholding parenteral nutrition for 1 week (late-parenteral nutrition), compared with early supplementation within 24 h of admission to the paediatric intensive care unit (early-parenteral nutrition), prevented infections, accelerated recovery, and improved neurocognitive development assessed 2 years later. Because several neurocognitive domains can only be thoroughly assessed from age 4 years onwards, we aimed to determine the effect of late-parenteral nutrition versus early-parenteral nutrition on physical, neurocognitive, and emotional and behavioural development 4 years after randomisation.
METHODS


This is a preplanned, blinded, 4-year follow-up study of participants included in the PEPaNIC trial (done at University Hospitals Leuven, Belgium; Erasmus Medical Centre Sophia Children's Hospital, Rotterdam, Netherlands; and Stollery Children's Hospital, Edmonton, AB, Canada) and of matched healthy children. Studied outcomes were anthropometrics; health status; parent-reported or caregiver-reported executive functions, and emotional and behavioural problems; and clinical tests for intelligence, visual-motor integration, alertness, motor coordination, and memory. Through multivariable linear and logistic regression analyses, after imputation for missing values (≤30%) and adjustment for risk factors, we investigated the effect of early-parenteral nutrition versus late-parenteral nutrition. This trial is registered with ClinicalTrials.gov, NCT01536275.
FINDINGS


Between March 8, 2016, and Nov 8, 2019, 684 children from the original PEPaNIC trial (356 from the late-parenteral nutrition group and 328 from the early-parenteral nutrition group) were assessed for neurocognitive development at 4-years follow-up. Compared with the control group (369 healthy children), children who had critical illness had lower height (β-estimate -2·11 [95% CI -3·15 to -1·06]; p<0·0001) and head circumference (-0·42 [-0·67 to -0·18]; p=0.00077); and worse health status (eg, hospital admission odds ratio 4·27 [95% CI 3·12 to 5·84]; p<0·0001), neurocognitive (eg, parent-reported or caregiver-reported total executive functioning β-estimate 3·57 [95% CI 1·95 to 5·18], p<0·0001; total intelligence quotient -7·35 [-9·31 to -5·39], p<0·0001), and parent-reported or caregiver-reported emotional and behavioural developmental outcomes (internalising 2·73 [1·19 to 4·28], p=0·00055; externalising 1·63 [0·19 to 3·08], p=0·027; and total behavioural problems 2·95 [1·44 to 4·46], p=0·00013), adjusted for risk factors. Outcomes were never worse in the late-parenteral nutrition group compared with the early-parenteral nutrition group, but patients in the late-parenteral nutrition group had fewer parent-reported or caregiver-reported internalising (β-estimate -1·88 [95% CI -3·69 to -0·07]; p=0·042), externalising (-1·73 [-3·43 to -0·03]; p=0·046), and total emotional and behavioural problems (-2·44 [-4·22 to -0·67]; p=0·0070) than patients who had received early-parenteral nutrition, after adjusting for risk factors, and were no longer different from healthy controls for these outcomes.
INTERPRETATION


Omitting early parenteral nutrition use for critically ill children did not adversely affect long-term outcomes 4 years after randomisation and protected against emotional and behavioural problems, further supporting the deimplementation of early parenteral nutrition.
FUNDING


European Research Council, Methusalem, Flanders Institute for Science and Technology, Research Foundation Flanders, Sophia Foundation, Stichting Agis Zorginnovatie, Erasmus Trustfonds, and the European Society for Clinical Nutrition and Metabolism.",2020,"p=0·00055; externalising 1·63 [0·19 to 3·08], p=0·027; and total behavioural problems 2·95 [1·44 to 4·46], p=0·00013), adjusted for risk factors.","['Between March 8, 2016, and Nov 8, 2019, 684 children from the original PEPaNIC trial (356 from the late-parenteral nutrition group and 328 from the early-parenteral nutrition group', '369 healthy children), children who had critical illness had lower height (β-estimate -2·11', 'paediatric intensive care units', ""participants included in the PEPaNIC trial (done at University Hospitals Leuven, Belgium; Erasmus Medical Centre Sophia Children's Hospital, Rotterdam, Netherlands; and Stollery Children's Hospital, Edmonton, AB, Canada) and of matched healthy children"", '1440 critically ill infants and children in 2012-15, showed that withholding parenteral nutrition for 1 week (late-parenteral nutrition), compared with early supplementation within 24 h of admission to the paediatric intensive care unit (early-parenteral nutrition), prevented infections, accelerated recovery, and improved neurocognitive development assessed 2 years later']","['4·22 to -0·67', '7·35', 'withholding parenteral nutrition']","['neurocognitive development', 'neurocognitive (eg, parent-reported or caregiver-reported total executive functioning β-estimate 3·57', 'anthropometrics; health status; parent-reported or caregiver-reported executive functions, and emotional and behavioural problems; and clinical tests for intelligence, visual-motor integration, alertness, motor coordination, and memory', 'total emotional and behavioural problems (-2·44', 'total intelligence quotient', 'worse health status (eg, hospital admission odds ratio 4·27', 'head circumference (-0·42 [-0·67 to -0·18']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C4517576', 'cui_str': '1440'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}]","[{'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0456149', 'cui_str': 'Intelligence quotient'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}]",684.0,0.251002,"p=0·00055; externalising 1·63 [0·19 to 3·08], p=0·027; and total behavioural problems 2·95 [1·44 to 4·46], p=0·00013), adjusted for risk factors.","[{'ForeName': 'An', 'Initials': 'A', 'LastName': 'Jacobs', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Karolijn', 'Initials': 'K', 'LastName': 'Dulfer', 'Affiliation': ""Intensive Care Unit, Department of Paediatrics and Paediatric Surgery, Erasmus Medical Centre, Sophia Children's Hospital, Rotterdam, Netherlands.""}, {'ForeName': 'Renate D', 'Initials': 'RD', 'LastName': 'Eveleens', 'Affiliation': ""Intensive Care Unit, Department of Paediatrics and Paediatric Surgery, Erasmus Medical Centre, Sophia Children's Hospital, Rotterdam, Netherlands.""}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Hordijk', 'Affiliation': ""Intensive Care Unit, Department of Paediatrics and Paediatric Surgery, Erasmus Medical Centre, Sophia Children's Hospital, Rotterdam, Netherlands.""}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Van Cleemput', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Verlinden', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Pieter J', 'Initials': 'PJ', 'LastName': 'Wouters', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Liese', 'Initials': 'L', 'LastName': 'Mebis', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Gonzalo Garcia', 'Initials': 'GG', 'LastName': 'Guerra', 'Affiliation': ""Department of Paediatrics, Intensive Care Unit, University of Alberta, Stollery Children's Hospital, Edmonton, Canada.""}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Joosten', 'Affiliation': ""Intensive Care Unit, Department of Paediatrics and Paediatric Surgery, Erasmus Medical Centre, Sophia Children's Hospital, Rotterdam, Netherlands.""}, {'ForeName': 'Sascha C', 'Initials': 'SC', 'LastName': 'Verbruggen', 'Affiliation': ""Intensive Care Unit, Department of Paediatrics and Paediatric Surgery, Erasmus Medical Centre, Sophia Children's Hospital, Rotterdam, Netherlands.""}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Güiza', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Vanhorebeek', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Greet', 'Initials': 'G', 'LastName': 'Van den Berghe', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, Katholieke Universiteit Leuven, Leuven, Belgium. Electronic address: greet.vandenberghe@kuleuven.be.'}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(20)30104-8']
3058,32562650,"Overall, anti-malarial, and non-malarial effect of intermittent preventive treatment during pregnancy with sulfadoxine-pyrimethamine on birthweight: a mediation analysis.","BACKGROUND


Trials of intermittent preventive treatment (IPTp) of malaria in pregnant women that compared dihydroartemisinin-piperaquine with the standard of care, sulfadoxine-pyrimethamine, showed dihydroartemisinin-piperaquine was superior at preventing malaria infection, but not at improving birthweight. We aimed to assess whether sulfadoxine-pyrimethamine shows greater non-malarial benefits for birth outcomes than does dihydroartemisinin-piperaquine, and whether dihydroartemisinin-piperaquine shows greater antimalarial benefits for birth outcomes than does sulfadoxine-pyrimethamine.
METHODS


We defined treatment as random assignment to sulfadoxine-pyrimethamine or dihydroartemisinin-piperaquine before pooling individual participant-level data from 1617 HIV-uninfected pregnant women in Kenya (one trial; n=806) and Uganda (two trials; n=811). We quantified the relative effect of treatment on birthweight (primary outcome) attributed to preventing placental malaria infection (mediator). We estimated antimalarial (indirect) and non-malarial (direct) effects of IPTp on birth outcomes using causal mediation analyses, accounting for confounders. We used two-stage individual participant data meta-analyses to calculate pooled-effect sizes.
FINDINGS


Overall, birthweight was higher among neonates of women randomly assigned to sulfadoxine-pyrimethamine compared with women assigned to dihydroartemisinin-piperaquine (mean difference 69 g, 95% CI 26 to 112), despite placental malaria infection being lower in the dihydroartemisinin-piperaquine group (relative risk [RR] 0·64, 95% CI 0·39 to 1·04). Mediation analyses showed sulfadoxine-pyrimethamine conferred a greater non-malarial effect than did dihydroartemisinin-piperaquine (mean difference 87 g, 95% CI 43 to 131), whereas dihydroartemisinin-piperaquine conferred a slightly larger antimalarial effect than did sulfadoxine-pyrimethamine (8 g, -9 to 26), although more frequent dosing increased the antimalarial effect (31 g, 3 to 60).
INTERPRETATION


IPTp with sulfadoxine-pyrimethamine appears to have potent non-malarial effects on birthweight. Further research is needed to evaluate monthly dihydroartemisinin-piperaquine with sulfadoxine-pyrimethamine (or another compound with non-malarial effects) to achieve greater protection against malarial and non-malarial causes of low birthweight.
FUNDING


Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bill & Melinda Gates Foundation, and Worldwide Antimalarial Resistance Network.",2020,"Overall, birthweight was higher among neonates of women randomly assigned to sulfadoxine-pyrimethamine compared with women assigned to dihydroartemisinin-piperaquine (mean difference 69","['pregnant women that compared dihydroartemisinin-piperaquine with the standard of care', '1617 HIV-uninfected pregnant women in Kenya (one trial; n=806) and Uganda (two trials; n=811']","['sulfadoxine-pyrimethamine', 'sulfadoxine-pyrimethamine or dihydroartemisinin-piperaquine', 'IPTp']","['placental malaria infection (mediator', 'antimalarial effect', 'Overall, birthweight', 'placental malaria infection']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]","[{'cui': 'C0700599', 'cui_str': 'Pyrimethamine- and sulfadoxine-containing product'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}]","[{'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0003374', 'cui_str': 'Antimalarial'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}]",1617.0,0.206058,"Overall, birthweight was higher among neonates of women randomly assigned to sulfadoxine-pyrimethamine compared with women assigned to dihydroartemisinin-piperaquine (mean difference 69","[{'ForeName': 'Michelle E', 'Initials': 'ME', 'LastName': 'Roh', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA; Malaria Elimination Initiative, Global Health Group, University of California, San Francisco, CA, USA. Electronic address: michelle.roh@ucsf.edu.'}, {'ForeName': 'Feiko O Ter', 'Initials': 'FOT', 'LastName': 'Kuile', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Rerolle', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA; Malaria Elimination Initiative, Global Health Group, University of California, San Francisco, CA, USA.'}, {'ForeName': 'M Maria', 'Initials': 'MM', 'LastName': 'Glymour', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Shiboski', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Roly', 'Initials': 'R', 'LastName': 'Gosling', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA; Malaria Elimination Initiative, Global Health Group, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Gutman', 'Affiliation': 'Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Abel', 'Initials': 'A', 'LastName': 'Kakuru', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Meghna', 'Initials': 'M', 'LastName': 'Desai', 'Affiliation': 'Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kajubi', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': ""L'Ianziva"", 'Affiliation': 'Centers for Disease Control and Prevention, Kisumu, Kenya.'}, {'ForeName': 'Moses R', 'Initials': 'MR', 'LastName': 'Kamya', 'Affiliation': 'School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Dorsey', 'Affiliation': 'Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'R Matthew', 'Initials': 'RM', 'LastName': 'Chico', 'Affiliation': 'Department of Disease Control, Faculty of Infectious and Tropical Disease, London School of Hygiene & Tropical Medicine, London, UK.'}]",The Lancet. Global health,['10.1016/S2214-109X(20)30119-4']
3059,32562670,Extended short-term follow-up for a trial of treatment of unruptured arteriovenous malformations.,,2020,,[],[],[],[],[],[],,0.0181838,,"[{'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Rothwell', 'Affiliation': 'Wolfson Centre for Prevention of Stroke and Dementia, Nuffield Department of Clinical Neurosciences, University of Oxford, John Radcliffe Hospital, Oxford, OX3 9DU, UK. Electronic address: peter.rothwell@ndcn.ox.ac.uk.'}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30178-2']
3060,32447743,Pregnancy Outcomes During the Clinical Development Program of Cladribine in Multiple Sclerosis: An Integrated Analysis of Safety.,"INTRODUCTION


Although use of contraception was pre-specified during cladribine clinical trials for multiple sclerosis, some pregnancies did occur.
OBJECTIVE


This analysis reports on pregnancy outcomes in the cladribine clinical development program.
METHODS


Pregnancy outcomes in female patients (direct pregnancies) and those arising from partner pregnancies (i.e., female partners of male study participants with multiple sclerosis) were evaluated from an integrated safety analysis of ten studies of cladribine in multiple sclerosis (nine clinical trials and a long-term safety registry), with patients treated with cladribine tablets, parenteral cladribine, or placebo (all-exposed cohort; 1976 patients received cladribine and 802 received placebo). Pregnancies that occurred during the 'at-risk' period for cladribine (during treatment or within 6 months thereafter) are reported as a separate group.
RESULTS


In the all-exposed cohort, 70 direct pregnancies occurred among 62 female patients (cladribine, n = 49; placebo, n = 21). Pregnancy outcomes were: live births (cladribine, n = 19 [38.8%]; placebo, n = 9 [42.9%]), elective terminations (cladribine, n = 14 [28.6%]; placebo, n = 4 [19.0%]), spontaneous abortions (cladribine, n = 11 [22.4%]; placebo, n = 5 [23.8%]), and therapeutic terminations (cladribine, n = 5 [10.2%]; placebo, n = 2 [9.5%]); in the remaining placebo recipient, the pregnancy outcome was unknown. There were two reports of congenital malformations (cladribine, n = 1; placebo, n = 1), both of which occurred with pregnancies arising > 2 years after exposure to the last dose of study medication. Sixteen direct pregnancies occurred during the 'at-risk' period for cladribine; outcomes for these were: live births, n = 3 (18.8%); elective terminations, n = 10 (62.5%); spontaneous abortions, n = 2 (12.5%); and therapeutic terminations, n = 1 (6.2%). Corresponding findings for direct pregnancies among placebo recipients were (n = 11): live births, n = 5 (45.5%); elective terminations, n = 2 (18.2%); spontaneous abortions, n = 3 (27.3%); and unknown, n = 1 (9.1%). No cases of congenital malformation were reported for pregnancies during the 'at-risk' period. There were an additional nine partner pregnancies in female partners of cladribine-treated male patients, all of which resulted in live births; of these, two pregnancies occurred within the 'at-risk' period for cladribine.
CONCLUSIONS


While limited by the small number of pregnancies and related data from the cladribine clinical development program, highlighting the need for further study, the observations made in the present analysis were generally consistent with epidemiological data on pregnancy outcomes for the general population or women with multiple sclerosis. There were no congenital malformations in pregnancies that occurred during cladribine treatment or within 6 months after the last dose. As the data available for cladribine-exposed pregnancies in patients with multiple sclerosis are limited, a non-interventional post-authorization safety study has been initiated to obtain more information on this subject.
CLINICAL TRIAL REGISTRATION


CLARITY: NCT00213135; CLARITY Extension: NCT00641537; ORACLE MS: NCT00725985; ONWARD: NCT00436826; PREMIERE: NCT01013350.",2020,There were no congenital malformations in pregnancies that occurred during cladribine treatment or within 6 months after the last dose.,"['all-exposed cohort; 1976 patients received', 'female patients (direct pregnancies) and those arising from partner pregnancies (i.e., female partners of male study participants with multiple sclerosis', '62 female patients', 'Multiple Sclerosis', 'patients with multiple sclerosis', 'in multiple sclerosis (nine clinical trials and a long-term safety registry), with patients treated with', 'general population or women with multiple sclerosis']","['cladribine', 'cladribine tablets, parenteral cladribine, or placebo', 'cladribine and 802 received placebo', 'Cladribine', 'placebo']","['congenital malformation', 'Pregnancy Outcomes', 'congenital malformations', 'elective terminations', 'therapeutic terminations', 'live births', 'spontaneous abortions']","[{'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0919624', 'cui_str': 'Pregnancy of partner'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0092801', 'cui_str': 'Cladribine'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}]",,0.0987172,There were no congenital malformations in pregnancies that occurred during cladribine treatment or within 6 months after the last dose.,"[{'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Giovannoni', 'Affiliation': 'Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, 4 Newark Street, London, E1 2AT, UK. g.giovannoni@qmul.ac.uk.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Galazka', 'Affiliation': 'Merck, Aubonne, Switzerland, a division of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Schick', 'Affiliation': 'Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Leist', 'Affiliation': 'Comprehensive MS Center, Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Comi', 'Affiliation': 'Department of Neurology and Institute of Experimental Neurology, Università Vita-Salute San Raffaele, Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Montalban', 'Affiliation': ""Division of Neurology, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Damian', 'Affiliation': 'EMD Serono Research and Development Institute, Inc., Billerica, MA, USA.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Dangond', 'Affiliation': 'EMD Serono Research and Development Institute, Inc., Billerica, MA, USA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Cook', 'Affiliation': 'New Jersey Medical School, Rutgers, The State University of New Jersey, Newark, NJ, USA.'}]",Drug safety,['10.1007/s40264-020-00948-x']
3061,32452590,The effects of indoor ambient temperature at work on physiological adaptation in night shift nurses.,"AIM


To examine the effects of indoor ambient temperature on thermal comfort, night work tolerance (fatigue, sleepiness and night adaptation) and urinary melatonin in night shift nurses.
BACKGROUND


Night shift induces physical stress and mental stress. Night shift work and ambient temperature are associated with work performance. The working environment must be improved for successful night shift working. However, the effects of indoor ambient temperature on night shift nurses are unclear.
METHODS


In this crossover study, 20 participants were divided into two groups of 10 and were assigned to work in one of two thermo-controlled environments (23°C vs. 26°C) during two consecutive night shifts. Thermal and humidity sensation vote, night work tolerance, body temperature and urinary melatonin were assessed.
RESULTS


There were significant differences between the two groups in thermal sensation and body temperature. There were no significant differences in humidity sensation vote or night work tolerance. Urinary melatonin levels decreased significantly during the second 23°C night shift.
CONCLUSION


A temperature of 23°C may exert a positive effect on night shift adaptation.
IMPLICATIONS FOR NURSING MANAGEMENT


Nurses and nursing managers should assess thermal comfort during night shifts, and improved thermal comfort level should be provided to nurses.",2020,There were significant differences between the two groups in thermal sensation vote and body temperature.,"['nursing management Nurses and nursing managers', 'Night Shift Nurses', '20 participants']","['indoor ambient temperature', 'Indoor Ambient Temperature']","['Urinary melatonin levels', 'Thermal and humidity sensation vote, night work tolerance, body temperature, and urinary melatonin', 'thermal comfort, night work tolerance (fatigue, sleepiness, and night adaptation', 'humidity sensation vote or night work tolerance', 'thermal sensation vote and body temperature']","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0335141', 'cui_str': 'Manager'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0333051', 'cui_str': 'Shift'}]","[{'cui': 'C0542496', 'cui_str': 'Ambient temperature'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020167', 'cui_str': 'Humidity'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0042978', 'cui_str': 'Voting'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0039478', 'cui_str': 'Thermal sensation, function'}]",20.0,0.0098016,There were significant differences between the two groups in thermal sensation vote and body temperature.,"[{'ForeName': 'Jeong Hun', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Biomedical Research Institute, Pusan National University Hospital, Busan, Korea.'}, {'ForeName': 'Yeoungsuk', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Research Institute of Nursing Science, Kyungpook National University College of Nursing, Daegu, Korea.'}]",Journal of nursing management,['10.1111/jonm.13052']
3062,30422319,Pharmacokinetic Interactions of Rolapitant With Cytochrome P450 3A Substrates in Healthy Subjects.,"Rolapitant (Varubi) is a neurokinin-1 receptor antagonist approved for the prevention of chemotherapy-induced nausea and vomiting. Rolapitant is primarily metabolized by the cytochrome P450 3A4 (CYP3A4) enzyme. Unlike other neurokinin-1 receptor antagonists, rolapitant is neither an inhibitor nor an inducer of CYP3A4 in vitro. The objective of this analysis was to examine the pharmacokinetics of rolapitant in healthy subjects and assess drug-drug interactions between rolapitant and midazolam (a CYP3A substrate), ketoconazole (a CYP3A inhibitor), or rifampin (a CYP3A4 inducer). Three phase 1, open-label, drug-drug interaction studies were conducted to examine the pharmacokinetic interactions of orally administered rolapitant with midazolam, rolapitant with ketoconazole, and rolapitant with rifampin. The pharmacokinetic profiles of midazolam and 1-hydroxy midazolam metabolites were essentially unchanged when coadministered with rolapitant, indicating the lack of a clinically relevant inhibition or induction of CYP3A by rolapitant. Coadministration of ketoconazole with rolapitant had no effects on rolapitant maximum concentration and resulted in an approximately 20% increase in the area under the concentration-time curve of rolapitant, suggesting that strong CYP3A inhibitors have minimal inhibitory effects on rolapitant exposure. Repeated administrations of rifampin appeared to reduce rolapitant exposure, resulting in a 33% decrease in maximum concentration and 87% decrease in area under the concentration-time curve from time zero to infinity. Coadministration of rolapitant did not affect the exposure of midazolam. Rifampin coadministration resulted in lower concentrations of rolapitant, and ketoconazole coadministration had no or minimal effects on rolapitant exposure. Rolapitant was safe and well tolerated when coadministered with ketoconazole, rifampin, or midazolam. No new safety signals were reported compared with previous studies of rolapitant.",2019,"Coadministration of ketoconazole with rolapitant had no effects on rolapitant maximum concentration and resulted in an approximately 20% increase in the area under the concentration-time curve of rolapitant, suggesting that strong CYP3A inhibitors have minimal inhibitory effects on rolapitant exposure.","['healthy subjects', 'Healthy Subjects']","['ketoconazole', 'Rolapitant With Cytochrome P450 3A Substrates', 'midazolam and 1-hydroxy midazolam metabolites', 'midazolam', 'Rifampin coadministration', 'ketoconazole, rifampin, or midazolam', 'midazolam (a CYP3A substrate), ketoconazole (a CYP3A inhibitor), or rifampin', 'midazolam, rolapitant with ketoconazole, and rolapitant with rifampin', 'rifampin']","['safe and well tolerated', 'rolapitant maximum concentration', 'nausea and vomiting', 'maximum concentration']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0022625', 'cui_str': 'Ketoconazole'}, {'cui': 'C3273719', 'cui_str': 'rolapitant'}, {'cui': 'C0059563', 'cui_str': 'Cytochrome p450 CYP3A enzyme'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C3850056', 'cui_str': 'P450 CYP3A Inhibitors'}]","[{'cui': 'C3273719', 'cui_str': 'rolapitant'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}]",,0.0910489,"Coadministration of ketoconazole with rolapitant had no effects on rolapitant maximum concentration and resulted in an approximately 20% increase in the area under the concentration-time curve of rolapitant, suggesting that strong CYP3A inhibitors have minimal inhibitory effects on rolapitant exposure.","[{'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'TESARO, Inc., Waltham, MA, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'TESARO, Inc., Waltham, MA, USA.'}, {'ForeName': 'Sujata', 'Initials': 'S', 'LastName': 'Arora', 'Affiliation': 'TESARO, Inc., Waltham, MA, USA.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Hughes', 'Affiliation': 'TESARO, Inc., Waltham, MA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Christensen', 'Affiliation': 'TESARO, Inc., Waltham, MA, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'TESARO, Inc., Waltham, MA, USA.'}, {'ForeName': 'Zhi-Yi', 'Initials': 'ZY', 'LastName': 'Zhang', 'Affiliation': 'TESARO, Inc., Waltham, MA, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1339']
3063,31175812,Steady Growth in Early Infancy Is Associated with Greater Anthropometry in Indian Children Born Low Birth Weight at Term.,"BACKGROUND


Patterns of early growth are associated with later body composition and risk of adult noncommunicable disease but information from low-income countries is limited.
OBJECTIVES


The aim of this study was to investigate early growth trajectories and later anthropometric and bone density outcomes among children born term low birth weight (LBW: 1.8-2.5 kg).
METHODS


We used data from 902 children from the Delhi Infant Vitamin D Supplementation study of LBW term infants (which collected monthly anthropometry from birth to 6 mo) and who had height, weight, midupper arm circumference (MUAC), midupper arm muscle circumference (MUAMC), subscapular and triceps skinfold thicknesses, tibia and radius bone density measured at age 4-6 y. We investigated how growth in the first 6 mo of life, modeled using the SuperImposition by Translation and Rotation (SITAR) growth curve model, was related to these outcomes. SITAR summarizes each infant's weight and length trajectory in terms of a population mean curve and child-specific growth parameters: size, timing, and intensity. These were included as explanatory variables in linear regression models for the childhood outcomes.
RESULTS


Considering the infant weight and length SITAR parameters jointly, childhood weight was strongly associated with infant length timing [estimated regression coefficient β = 0.25 (95% CI: 0.10, 0.39)] and with weight size, timing, and intensity [β = 9.01 (6.75, 11.27), β = -0.25 (-0.43, -0.07), β = 5.03 (3.22, 6.84), respectively]. Childhood height was associated only with the length parameters [β = 0.97 (0.71, 1.23), β = -0.43 (-0.77, -0.09), β = 11.68 (8.60, 14.75), respectively]; childhood MUAC, MUAMC, and skinfolds with all parameters; and bone density with none. Overall, delayed and sustained growth in infant weight and length resulted in higher values of all outcomes except bone density, with the period up to 15 wk of age appearing critical for setting childhood anthropometry in this population.
CONCLUSIONS


The explanation for the effects of delayed growth and length of the period in which trajectories are set is unclear; however, sustained and delayed growth in early infancy appears to be beneficial for these LBW children at least in the short-term. The trial was registered at clinicaltrials.gov as BT/PR7489/PID/20/285/2006.",2019,"Overall, delayed and sustained growth in infant weight and length resulted in higher values of all outcomes except bone density, with the period up to 15 wk of age appearing critical for setting childhood anthropometry in this population.
","['902 children from the Delhi Infant Vitamin D Supplementation study of LBW term infants (which collected monthly anthropometry from birth to 6 mo) and who had height, weight, midupper arm circumference (MUAC), midupper arm muscle circumference (MUAMC), subscapular and triceps skinfold thicknesses, tibia and radius bone density measured at age 4-6', 'Indian Children Born Low Birth Weight at Term', 'children born term low birth weight (LBW: 1.8-2.5 kg']",[],"['early growth trajectories and later anthropometric and bone density outcomes', 'Childhood height', 'childhood MUAC, MUAMC, and skinfolds with all parameters; and bone density']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086541', 'cui_str': 'Dry form of cutaneous leishmaniasis'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518022', 'cui_str': 'Triceps skin fold thickness'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0034627', 'cui_str': 'Bone structure of radius'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C3844011', 'cui_str': '2.5'}]",[],"[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",902.0,0.0609463,"Overall, delayed and sustained growth in infant weight and length resulted in higher values of all outcomes except bone density, with the period up to 15 wk of age appearing critical for setting childhood anthropometry in this population.
","[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Filteau', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Geeta Trilok', 'Initials': 'GT', 'LastName': 'Kumar', 'Affiliation': 'Institute of Home Economics, Delhi University, Delhi, India.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'Cole', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, London, United Kingdom.'}, {'ForeName': 'Harshpal S', 'Initials': 'HS', 'LastName': 'Sachdev', 'Affiliation': 'Sitaram Bhartia Institute of Science and Research, Delhi, India.'}, {'ForeName': 'Bianca L', 'Initials': 'BL', 'LastName': 'De Stavola', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",The Journal of nutrition,['10.1093/jn/nxz113']
3064,32562682,"Medical management with interventional therapy versus medical management alone for unruptured brain arteriovenous malformations (ARUBA): final follow-up of a multicentre, non-blinded, randomised controlled trial.","BACKGROUND


In A Randomized trial of Unruptured Brain Arteriovenous malformations (ARUBA), randomisation was halted at a mean follow-up of 33·3 months after a prespecified interim analysis showed that medical management alone was superior to the combination of medical management and interventional therapy in preventing symptomatic stroke or death. We aimed to study whether these differences persisted through 5-years' follow-up.
METHODS


ARUBA was a non-blinded, randomised trial done at 39 clinical centres in nine countries. Adults (age ≥18 years) diagnosed with an unruptured brain arteriovenous malformation, who had never undergone interventional therapy, and were considered by participating clinical centres to be suitable for intervention to eradicate the lesion, were eligible for inclusion. Patients were randomly assigned (1:1) by a web-based data collection system, stratified by clinical centre in a random permuted block design with block sizes of two, four, and six, to medical management alone or with interventional therapy (neurosurgery, embolisation, or stereotactic radiotherapy, alone or in any combination, sequence, or number). Although patients and investigators at a given centre were not masked to treatment assignment, investigators at other centres and those in the clinical coordinating centre were not informed of assignment or outcomes at any of the centres. The primary outcome was time to death or symptomatic stroke confirmed by imaging, assessed by a neurologist at each centre not involved in the management of participants' care, and monitored by an independent committee using an adaptive approach with interim analyses. Enrolment began on April 4, 2007, and was halted on April 15, 2013, after which follow-up continued until July 15, 2015. All analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, NCT00389181.
FINDINGS


Of 1740 patients screened, 226 were randomly assigned to medical management alone (n=110) or medical management plus interventional therapy (n=116). During a mean follow-up of 50·4 months (SD 22·9), the incidence of death or symptomatic stroke was lower with medical management alone (15 of 110, 3·39 per 100 patient-years) than with medical management with interventional therapy (41 of 116, 12·32 per 100 patient-years; hazard ratio 0·31, 95% CI 0·17 to 0·56). Two patients in the medical management group and four in the interventional therapy group (two attributed to intervention) died during follow-up. Adverse events were observed less often in patients allocated to medical management compared with interventional therapy (283 vs 369; 58·97 vs 78·73 per 100 patient-years; risk difference -19·76, 95% CI -30·33 to -9·19).
INTERPRETATION


After extended follow-up, ARUBA showed that medical management alone remained superior to interventional therapy for the prevention of death or symptomatic stroke in patients with an unruptured brain arteriovenous malformation. The data concerning the disparity in outcomes should affect standard specialist practice and the information presented to patients. The even longer-term risks and differences between the two therapeutic approaches remains uncertain.
FUNDING


National Institute of Neurological Disorders and Stroke for the randomisation phase and Vital Projects Fund for the follow-up phase.",2020,"After extended follow-up, ARUBA showed that medical management alone remained superior to interventional therapy for the prevention of death or symptomatic stroke in patients with an unruptured brain arteriovenous malformation.","['patients with an unruptured brain arteriovenous malformation', '1740 patients screened, 226 were randomly assigned to', '39 clinical centres in nine countries', 'Adults (age ≥18 years) diagnosed with an unruptured brain arteriovenous malformation, who had never undergone interventional therapy, and were considered by participating clinical centres to be suitable for intervention to eradicate the lesion, were eligible for inclusion', 'unruptured brain arteriovenous malformations (ARUBA']","['interventional therapy versus medical management alone', 'medical management alone or with interventional therapy (neurosurgery, embolisation, or stereotactic radiotherapy, alone or in any combination, sequence, or number', 'medical management alone (n=110) or medical management plus interventional therapy']","['death or symptomatic stroke', 'Adverse events', ""time to death or symptomatic stroke confirmed by imaging, assessed by a neurologist at each centre not involved in the management of participants' care"", 'symptomatic stroke or death', 'incidence of death or symptomatic stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0003857', 'cui_str': 'Congenital arteriovenous malformation'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}, {'cui': 'C3846112', 'cui_str': 'Stereotactic radiosurgery'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0237426', 'cui_str': 'Neurologist'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205429', 'cui_str': 'Uninvolved'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",226.0,0.149025,"After extended follow-up, ARUBA showed that medical management alone remained superior to interventional therapy for the prevention of death or symptomatic stroke in patients with an unruptured brain arteriovenous malformation.","[{'ForeName': 'Jay P', 'Initials': 'JP', 'LastName': 'Mohr', 'Affiliation': 'Doris and Stanley Tananbaum Stroke Center, The Neurological Institute, Columbia University Irving Medical Center, New York, NY, USA. Electronic address: jpm10@cumc.columbia.edu.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Overbey', 'Affiliation': 'International Center for Health Outcomes and Innovation Research, Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hartmann', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Department of Neurology, Klinikum Frankfurt/Oder, Frankfurt/Oder, Germany.'}, {'ForeName': 'Rüdiger von', 'Initials': 'RV', 'LastName': 'Kummer', 'Affiliation': 'Department of Neuroradiology, University Hospital Dresden, Dresden, Germany.'}, {'ForeName': 'Rustam', 'Initials': 'R', 'LastName': 'Al-Shahi Salman', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesia and Perioperative Care, Center for Cerebrovascular Research, University of California, San Francisco, CA, USA.'}, {'ForeName': 'H Bart', 'Initials': 'HB', 'LastName': 'van der Worp', 'Affiliation': 'Department of Neurology and Neurosurgery, University Medical Center Utrecht, Brain Center, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Parides', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, Albert Einstein Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'Stefani', 'Affiliation': 'Department of Neurology and Neurosurgery, Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Houdart', 'Affiliation': 'Department of Neuroradiology, APHP-Hôpital Lariboisière, Université Paris Diderot-Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Libman', 'Affiliation': 'Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Pile-Spellman', 'Affiliation': 'Department of Neuroradiology, NYU-Winthrop Medical Center, Mineola, NY, USA.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Harkness', 'Affiliation': 'Department of Neurology, Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Cordonnier', 'Affiliation': 'Université Lille, Inserm, CHU Lille, U1172, LilNCog, Lille Neuroscience and Cognition, Lille, France.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Moquete', 'Affiliation': 'International Center for Health Outcomes and Innovation Research, Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Biondi', 'Affiliation': 'Department of Interventional Neuroradiology, Jean Minjoz Hospital, University of Franche Comté, Besançon, France.'}, {'ForeName': 'Catharina J M', 'Initials': 'CJM', 'LastName': 'Klijn', 'Affiliation': 'Department of Neurology and Neurosurgery, University Medical Center Utrecht, Brain Center, Utrecht University, Utrecht, Netherlands; Department of Neurology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Stapf', 'Affiliation': ""Neuroscience Axis, Neurovascular Group, Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Division of Neurology, Centre Hospitalier de l'Université de Montréal, Montréal, QC, Canada; Department of Neurosciences, Faculty of Medicine, Université de Montréal, Montréal, QC, Canada.""}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Moskowitz', 'Affiliation': 'International Center for Health Outcomes and Innovation Research, Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30181-2']
3065,32562683,Effect of dulaglutide on cognitive impairment in type 2 diabetes: an exploratory analysis of the REWIND trial.,"BACKGROUND


Diabetes is an independent risk factor for cognitive impairment. We aimed to investigate the association between the glucagon-like peptide-1 (GLP-1) receptor agonist dulaglutide and cognitive impairment as an exploratory analysis within the Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND) trial.
METHODS


REWIND is a randomised, double-blind placebo-controlled trial at 371 sites in 24 countries. We included men and women (aged ≥50 years) with either established or newly diagnosed type 2 diabetes and additional cardiovascular risk factors, glycated haemoglobin of up to 9·5% (80 mmol/mol) on a maximum of two oral glucose-lowering drugs with or without basal insulin, and a body-mass index of at least 23 kg/m 2 . Participants were randomly assigned (1:1) subcutaneous injections once a week of either dulaglutide (1·5 mg) or an equal volume of matching placebo. Randomisation was done using a computer-generated code with stratification by site. Participants and all study personnel were masked to treatment allocation until the database was locked. Participants were followed up at least every 6 months for the composite primary outcome of stroke, myocardial infarction, or death from cardiovascular or unknown causes. Cognitive function was assessed at baseline and during follow-up using the Montreal Cognitive Assessment (MoCA) and Digit Symbol Substitution Test (DSST). We present here the exploratory primary cognitive outcome, which was the first occurrence of a follow-up score on MoCA or DSST that was 1·5 SDs or more below the baseline mean score in the participant's country. All analyses were done using an intention-to-treat approach. The REWIND trial is registered with ClinicalTrials.gov, NCT01394952.
FINDINGS


Between Aug 18, 2011, and Aug 14, 2013, 9901 participants were randomly assigned to either dulaglutide (n=4949) or placebo (n=4952). During median follow-up of 5·4 (IQR 5·1-5·9) years, 8828 participants provided a baseline and one or more follow-up MoCA or DSST scores, of whom 4456 were assigned dulaglutide and 4372 were assigned placebo. The cognitive outcome occurred in 4·05 per 100 patient-years in participants assigned dulaglutide and 4·35 per 100 patient-years in people assigned placebo (hazard ratio [HR] 0·93, 95% CI 0·85-1·02; p=0·11). After post-hoc adjustment for individual standardised baseline scores, the hazard of substantive cognitive impairment was reduced by 14% in those assigned dulaglutide (HR 0·86, 95% CI 0·79-0·95; p=0·0018).
INTERPRETATION


Long-term treatment with dulaglutide might reduce cognitive impairment in people with type 2 diabetes. Further studies of this drug focused on brain health and cognitive function are clearly indicated.
FUNDING


Eli Lilly and Company.",2020,"After post-hoc adjustment for individual standardised baseline scores, the hazard of substantive cognitive impairment was reduced by 14% in those assigned dulaglutide (HR 0·86, 95% CI 0·79-0·95; p=0·0018).
","['371 sites in 24 countries', '8828 participants provided a baseline and one or more follow-up MoCA or DSST scores, of whom 4456 were assigned dulaglutide and 4372 were assigned', 'men and women (aged ≥50 years) with either established or newly diagnosed type 2 diabetes and additional cardiovascular risk factors, glycated haemoglobin of up to 9·5% (80 mmol/mol) on a maximum of two oral glucose-lowering drugs with or without basal insulin, and a body-mass index of at least 23 kg/m 2 ', 'Between Aug 18, 2011, and Aug 14, 2013, 9901 participants', 'type 2 diabetes', 'people with type 2 diabetes']","['placebo', 'dulaglutide (1·5 mg) or an equal volume of matching placebo', 'dulaglutide', 'glucagon-like peptide-1 (GLP-1) receptor agonist dulaglutide']","['hazard of substantive cognitive impairment', 'stroke, myocardial infarction, or death from cardiovascular or unknown causes', 'cognitive outcome', 'Cognitive function', 'cognitive impairment', 'Montreal Cognitive Assessment (MoCA) and Digit Symbol Substitution Test (DSST']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C2987634', 'cui_str': 'Receptor agonist'}]","[{'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",9901.0,0.689964,"After post-hoc adjustment for individual standardised baseline scores, the hazard of substantive cognitive impairment was reduced by 14% in those assigned dulaglutide (HR 0·86, 95% CI 0·79-0·95; p=0·0018).
","[{'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Cukierman-Yaffe', 'Affiliation': 'Endocrinology Institute, Gertner Institute, Sheba Medical Center, Ramat-Gan, Israel; Epidemiology Department, Sackler School of Medicine, Herceg Institute of Aging, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Hertzel C', 'Initials': 'HC', 'LastName': 'Gerstein', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada. Electronic address: gerstein@mcmaster.ca.'}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Colhoun', 'Affiliation': 'University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Clínicos Latino América, Rosario, Argentina.'}, {'ForeName': 'Luis-Emilio', 'Initials': 'LE', 'LastName': 'García-Pérez', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lakshmanan', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Angelyn', 'Initials': 'A', 'LastName': 'Bethel', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Xavier', 'Affiliation': ""St John's Medical College, Bangalore, India.""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Probstfield', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Riddle', 'Affiliation': 'Department of Medicine, Oregon Health and Science University Portland, OR, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Rydén', 'Affiliation': 'Department of Medicine K2, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Charles Messan', 'Initials': 'CM', 'LastName': 'Atisso', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Hall', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Purnima', 'Initials': 'P', 'LastName': 'Rao-Melacini', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Basile', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Cushman', 'Affiliation': 'Memphis Veterans Affairs Medical Center, Memphis, TN, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Franek', 'Affiliation': 'Mossakowski Medical Research Centre, Polish Academy of Sciences and Central Clinical Hospital, Warsaw, Poland.'}, {'ForeName': 'Matyas', 'Initials': 'M', 'LastName': 'Keltai', 'Affiliation': 'Semmelweis University, Hungarian Institute of Cardiology, Budapest, Hungary.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Lanas', 'Affiliation': 'Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Patricio', 'Initials': 'P', 'LastName': 'Lopez-Jaramillo', 'Affiliation': 'Masira Research Institute, Medical School, Universidad de Santander, Bucaramanga, Colombia.'}, {'ForeName': 'Valdis', 'Initials': 'V', 'LastName': 'Pirags', 'Affiliation': 'Latvijas Universitate, Riga, Latvia.'}, {'ForeName': 'Nana', 'Initials': 'N', 'LastName': 'Pogosova', 'Affiliation': 'National Medical Research Center of Cardiology, Moscow, Russia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Raubenheimer', 'Affiliation': 'Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Shaw', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, VIC, Australia.'}, {'ForeName': 'Wayne H-H', 'Initials': 'WH', 'LastName': 'Sheu', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan.'}, {'ForeName': 'Theodora', 'Initials': 'T', 'LastName': 'Temelkova-Kurktschiev', 'Affiliation': 'Robert Koch Medical Center, Sofia, Bulgaria.'}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30173-3']
3066,32562684,"Safety and immunogenicity of the α-synuclein active immunotherapeutic PD01A in patients with Parkinson's disease: a randomised, single-blinded, phase 1 trial.","BACKGROUND


Robust evidence supports the role of α-synuclein pathology as a driver of neuronal dysfunction in Parkinson's disease. PD01A is a specific active immunotherapy with a short peptide formulation targeted against oligomeric α-synuclein. This phase 1 study assessed the safety and tolerability of the PD01A immunotherapeutic in patients with Parkinson's disease.
METHODS


We did a first-in-human, randomised, phase 1 study of immunisations with PD01A, followed by three consecutive study extensions. Patients aged 45-65 years with a clinical diagnosis of Parkinson's disease (≤4 years since diagnosis and Hoehn and Yahr Stage 1 to 2), imaging results (dopamine transporter single photon emission CT and MRI) consistent with their Parkinson's disease diagnosis, and on stable doses of Parkinson's disease medications for at least 3 months were recruited at a single private clinic in Vienna, Austria. Patients were randomly assigned (1:1), using a computer-generated sequence with varying block size, to receive four subcutaneous immunisations with either 15 μg or 75 μg PD01A injected into the upper arms and followed up initially for 52 weeks, followed by a further 39 weeks' follow-up. Patients were then randomly assigned (1:1) again to receive the first booster immunisation at 15 μg or 75 μg and were followed up for 24 weeks. All patients received a second booster immunisation of 75 μg and were followed up for an additional 52 weeks. Patients were masked to dose allocation. Primary (safety) analyses included all treated patients. These four studies were registered with EU Clinical Trials Register, EudraCT numbers 2011-002650-31, 2013-001774-20, 2014-002489-54, and 2015-004854-16.
FINDINGS


32 patients were recruited between Feb 14, 2012, and Feb 6, 2013, and 24 were deemed eligible and randomly assigned to receive four PD01A priming immunisations. One patient had a diagnosis change to multiple system atrophy and was withdrawn and two patients withdrew consent during the studies. 21 (87%) of 24 patients received all six immunisations and completed 221-259 weeks in-study (two patients in the 15 μg dose group and one patient in the 75 μg dose group discontinued). All patients experienced at least one adverse event, but most of them were considered unrelated to study treatment (except for transient local injection site reactions, which affected all but one patient). Serial MRI assessments also ruled out inflammatory processes. Systemic treatment-related adverse events were fatigue (n=4), headache (n=3), myalgia (n=3), muscle rigidity (n=2), and tremor (n=2). The geometric group mean titre of antibodies against the immunising peptide PD01 increased from 1:46 at baseline to 1:3580 at week 12 in the 15 μg dose group, and from 1:76 to 1:2462 at week 12 in the 75 μg dose group. Antibody titres returned to baseline over 2 years, but could be rapidly reactivated after booster immunisation from week 116 onwards, reaching geometric group mean titres up to 1:20218.
INTERPRETATION


Repeated administrations of PD01A were safe and well tolerated over an extended period. Specific active immunotherapy resulted in a substantial humoral immune response with target engagement. Phase 2 studies are needed to further assess the safety and efficacy of PD01A for the treatment of Parkinson's disease.
FUNDING


AFFiRiS, Michael J Fox Foundation.",2020,"The geometric group mean titre of antibodies against the immunising peptide PD01 increased from 1:46 at baseline to 1:3580 at week 12 in the 15 μg dose group, and from 1:76 to 1:2462 at week 12 in the 75 μg dose group.","[""patients with Parkinson's disease"", ""Patients aged 45-65 years with a clinical diagnosis of Parkinson's disease (≤4 years since diagnosis and Hoehn and Yahr Stage 1 to 2), imaging results (dopamine transporter single photon emission CT and MRI) consistent with their Parkinson's disease diagnosis, and on stable doses of Parkinson's disease medications for at least 3 months were recruited at a single private clinic in Vienna, Austria"", 'These four studies were registered with EU Clinical Trials Register, EudraCT numbers 2011-002650-31, 2013-001774-20, 2014-002489-54, and 2015-004854-16', '32 patients were recruited between Feb 14, 2012, and Feb 6, 2013, and 24 were deemed eligible']","['PD01A', 'PD01A immunotherapeutic', 'α-synuclein active immunotherapeutic PD01A']","['Safety and immunogenicity', 'geometric group mean titre of antibodies against the immunising peptide PD01', 'safety and tolerability', 'headache (n=3), myalgia (n=3), muscle rigidity (n=2), and tremor (n=2', 'Antibody titres', 'safe and well tolerated']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0114838', 'cui_str': 'Dopamine Transporter'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0086805', 'cui_str': 'Photon'}, {'cui': 'C0233929', 'cui_str': 'Emission'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0237753', 'cui_str': 'Number'}]","[{'cui': 'C0165073', 'cui_str': 'Synuclein'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}]",32.0,0.129353,"The geometric group mean titre of antibodies against the immunising peptide PD01 increased from 1:46 at baseline to 1:3580 at week 12 in the 15 μg dose group, and from 1:76 to 1:2462 at week 12 in the 75 μg dose group.","[{'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Volc', 'Affiliation': 'Confraternitaet-Privatklinik Josefstadt, Vienna, Austria.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Poewe', 'Affiliation': 'Department of Neurology, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kutzelnigg', 'Affiliation': 'AFFiRiS, Vienna, Austria.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Lührs', 'Affiliation': 'AFFiRiS, Vienna, Austria.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Thun-Hohenstein', 'Affiliation': 'Confraternitaet-Privatklinik Josefstadt, Vienna, Austria.'}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Schneeberger', 'Affiliation': 'AFFiRiS, Vienna, Austria.'}, {'ForeName': 'Gergana', 'Initials': 'G', 'LastName': 'Galabova', 'Affiliation': 'AFFiRiS, Vienna, Austria.'}, {'ForeName': 'Nour', 'Initials': 'N', 'LastName': 'Majbour', 'Affiliation': 'Neurological Disorders Research Center, Qatar Biomedical Research Institute, Hamad Bin Khalifa University, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Nishant', 'Initials': 'N', 'LastName': 'Vaikath', 'Affiliation': 'Neurological Disorders Research Center, Qatar Biomedical Research Institute, Hamad Bin Khalifa University, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'El-Agnaf', 'Affiliation': 'Neurological Disorders Research Center, Qatar Biomedical Research Institute, Hamad Bin Khalifa University, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Dorian', 'Initials': 'D', 'LastName': 'Winter', 'Affiliation': 'AFFiRiS, Vienna, Austria.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Mihailovska', 'Affiliation': 'AFFiRiS, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Mairhofer', 'Affiliation': 'AFFiRiS, Vienna, Austria.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Schwenke', 'Affiliation': 'Schwenke Consulting: Strategies and Solutions in Statistics, Berlin, Germany.'}, {'ForeName': 'Günther', 'Initials': 'G', 'LastName': 'Staffler', 'Affiliation': 'AFFiRiS, Vienna, Austria. Electronic address: guenther.staffler@affiris.com.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Medori', 'Affiliation': 'AFFiRiS, Vienna, Austria.'}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30136-8']
3067,32562716,Antimicrobial Stewardship Intervention to Reduce Unnecessary Antibiotic Doses in Neonates.,The wording of the antibiotic duration orders for neonatal sepsis was changed as an antimicrobial stewardship initiative to reduce the administration of unnecessary antibiotic doses. The change in wording allowed the patient to stop receiving antibiotics after they received 48 hours of therapy if the health care team had not received notification of a positive culture. This initiative led to a decrease in the number of neonates that received extra unnecessary doses from 50% to 7.2%.,2020,This initiative led to a decrease in the number of neonates that received extra unnecessary doses from 50% to 7.2%.,['Neonates'],['Antimicrobial Stewardship Intervention'],[],"[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}]","[{'cui': 'C4505099', 'cui_str': 'Antimicrobial Stewardship'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.106856,This initiative led to a decrease in the number of neonates that received extra unnecessary doses from 50% to 7.2%.,"[{'ForeName': 'Brandi', 'Initials': 'B', 'LastName': 'Newby', 'Affiliation': 'Pharmacy Coordinator, Neonatal and Pediatric Pharmacy, Surrey Memorial Hospital. Electronic address: Brandi.newby@fraserhealth.ca.'}, {'ForeName': 'Sandy H S', 'Initials': 'SHS', 'LastName': 'Mok', 'Affiliation': 'Clinical Pharmacist, Neonatal and Pediatric Pharmacy, Surrey Memorial Hospital.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Clinical Pharmacist, Neonatal and Pediatric Pharmacy, Surrey Memorial Hospital.'}]",American journal of infection control,['10.1016/j.ajic.2020.06.177']
3068,32562721,Lower Adenoma Miss Rate of Computer-aided Detection-Assisted Colonoscopy vs Routine White-Light Colonoscopy in a Prospective Tandem Study.,"BACKGROUND & AIMS


Up to 30% of adenomas might be missed during screening colonoscopy-these could be polyps that appear on-screen but are not recognized by endoscopists or polyps that are in locations that do not appear on the screen at all. Computer-aided detection (CADe) systems, based on deep learning, might reduce rates of missed adenomas by displaying visual alerts that identify precancerous polyps on the endoscopy monitor in real time. We compared adenoma miss rates of CADe colonoscopy vs routine white-light colonoscopy.
METHODS


We performed a prospective study of patients, 18-75 years old, referred for diagnostic, screening, or surveillance colonoscopies at a single endoscopy center of Sichuan Provincial People's Hospital from June 3, 2019 through September 24, 2019. Same day, tandem colonoscopies were performed for each participant by the same endoscopist. Patients were randomly assigned to groups that received either CADe colonoscopy (n=184) or routine colonoscopy (n=185) first, followed immediately by the other procedure. Endoscopists were blinded to the group each patient was assigned to until immediately before the start of each colonoscopy. Polyps that were missed by the CADe system but detected by endoscopists were classified as missed polyps. False polyps were those continuously traced by the CADe system but then determined not to be polyps by the endoscopists. The primary endpoint was adenoma miss rate, which was defined as the number of adenomas detected in the second-pass colonoscopy divided by the total number of adenomas detected in both passes.
RESULTS


The adenoma miss rate was significantly lower with CADe colonoscopy (13.89%; 95% CI, 8.24%-19.54%) than with routine colonoscopy (40.00%; 95% CI, 31.23%-48.77%, P<.0001). The polyp miss rate significantly lower with CADe colonoscopy (12.98%; 95% CI, 9.08%-16.88%) than with routine colonoscopy (45.90%; 95% CI, 39.65%-52.15%) (P<.0001). Adenoma miss rates in ascending, transverse, and descending colon were significantly lower with CADe colonoscopy than with routine colonoscopy (ascending colon 6.67% vs 39.13%; P=.0095; transverse colon 16.33% vs 45.16%; P=.0065; and descending colon 12.50% vs 40.91%, P=.0364).
CONCLUSIONS


CADe colonoscopy reduced the overall miss rate of adenomas by endoscopists using white-light endoscopy. Routine use of CADe might reduce the incidence of interval colon cancers. chictr.org.cn study no: ChiCTR1900023086.",2020,"The polyp miss rate significantly lower with CADe colonoscopy (12.98%; 95% CI, 9.08%-16.88%) than with routine colonoscopy (45.90%; 95% CI, 39.65%-52.15%) (P<.0001).","[""patients, 18-75 years old, referred for diagnostic, screening, or surveillance colonoscopies at a single endoscopy center of Sichuan Provincial People's Hospital from June 3, 2019 through September 24, 2019""]","['CADe colonoscopy', 'Computer-aided Detection-Assisted Colonoscopy vs Routine White-Light Colonoscopy', 'CADe colonoscopy (n=184) or routine colonoscopy', 'CADe colonoscopy vs routine white-light colonoscopy', 'CADe']","['adenoma miss rate', 'Adenoma miss rates in ascending, transverse, and descending colon', 'incidence of interval colon cancers']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0563228', 'cui_str': 'White light'}]","[{'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0227389', 'cui_str': 'Descending colon structure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}]",,0.0444084,"The polyp miss rate significantly lower with CADe colonoscopy (12.98%; 95% CI, 9.08%-16.88%) than with routine colonoscopy (45.90%; 95% CI, 39.65%-52.15%) (P<.0001).","[{'ForeName': 'Pu', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': ""Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Peixi', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': ""Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Jeremy R', 'Initials': 'JR', 'LastName': 'Glissen Brown', 'Affiliation': 'Center for Advanced Endoscopy, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Tyler M', 'Initials': 'TM', 'LastName': 'Berzin', 'Affiliation': 'Center for Advanced Endoscopy, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Guanyu', 'Initials': 'G', 'LastName': 'Zhou', 'Affiliation': ""Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Lei', 'Affiliation': ""Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Xiaogang', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Liangping', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': ""Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China. Electronic address: xiaoxun001@outlook.com.""}]",Gastroenterology,['10.1053/j.gastro.2020.06.023']
3069,32562747,Effects of an 8-week resistance training intervention on plantar flexor muscle quality and functional capacity in older women: A randomised controlled trial.,"The present study examined 8 weeks of resistance training and its effects on muscle quality measures, plantar flexor muscle strength, muscle thickness and functional capacity in older women. Moreover, we tested if changes in muscle quality were associated with functional capacity. Twenty-four older women (66.3 ± 5.8 years; 69.0 ± 3.0 kg; 25.3 ± 1.4 kg·m -2 ) were recruited to the study. After completion of the baseline assessment, participants were randomly assigned to either the resistance training (RET, n = 12) or an active control group (CTR, n = 12). Muscle quality was evaluated through muscle echo intensity (MQ EI ) and specific tension (MQ ST ). Muscle thickness, unilateral plantar flexor muscle strength and functional tests were evaluated at baseline and after the training period. After 8 weeks, both MQ EI  and MQ ST  did not respond to the intervention. Furthermore, significant changes in stair climb performance (P < 0.05) were not associated with plantar flexor-derived muscle quality (P > 0.05). Finally, significant gains in muscle hypertrophy were observed in the RET group (P < 0.01), while muscle strength failed to change significantly (P > 0.05). In conclusion, a resistance training program provided significant benefits in the stair climb test, unrelated to plantar flexor-derived muscle quality measures as previously demonstrated in quadriceps femoris.",2020,"Furthermore, significant changes in stair climb performance (P < 0.05) were not associated with plantar flexor-derived muscle quality (P > 0.05).","['older women', 'Twenty-four older women (66.3\u202f±\u202f5.8\u202fyears; 69.0\u202f±\u202f3.0\u202fkg; 25.3\u202f±\u202f1.4\u202fkg·m -2 ']","['8-week resistance training intervention', 'resistance training (RET, n\u202f=\u202f12) or an active control', 'resistance training']","['stair climb performance', 'Muscle quality', 'plantar flexor-derived muscle quality', 'muscle quality', 'plantar flexor muscle quality and functional capacity', 'Muscle thickness, unilateral plantar flexor muscle strength and functional tests', 'muscle hypertrophy', 'muscle strength', 'muscle echo intensity (MQ EI ) and specific tension (MQ ST ', 'muscle quality measures, plantar flexor muscle strength, muscle thickness and functional capacity']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517503', 'cui_str': '1.4'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0389252', 'cui_str': 'RET protein, human'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0236033', 'cui_str': 'Muscle hypertrophy'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",24.0,0.0161992,"Furthermore, significant changes in stair climb performance (P < 0.05) were not associated with plantar flexor-derived muscle quality (P > 0.05).","[{'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Lopez', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Perth, Western Australia, Australia. Electronic address: p.lopezda@our.ecu.edu.au.'}, {'ForeName': 'Brendan James', 'Initials': 'BJ', 'LastName': 'Crosby', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Perth, Western Australia, Australia.'}, {'ForeName': 'Bruna Patrícia', 'Initials': 'BP', 'LastName': 'Robetti', 'Affiliation': 'Universidade de Caxias do Sul, Caxias do Sul, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Douglas Jean Preussler', 'Initials': 'DJP', 'LastName': 'Turella', 'Affiliation': 'Centro Clínico UCS, Universidade de Caxias do Sul, Caxias do Sul, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Thaís Andréia Schepa', 'Initials': 'TAS', 'LastName': 'Weber', 'Affiliation': 'Universidade de Caxias do Sul, Caxias do Sul, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Morgana Lima', 'Initials': 'ML', 'LastName': 'de Oliveira', 'Affiliation': 'Universidade de Caxias do Sul, Caxias do Sul, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Anderson', 'Initials': 'A', 'LastName': 'Rech', 'Affiliation': 'Universidade de Caxias do Sul, Caxias do Sul, Rio Grande do Sul, Brazil.'}]",Experimental gerontology,['10.1016/j.exger.2020.111003']
3070,32562806,Impact of health warning labels on snack selection: An online experimental study.,"Excessive consumption of energy-dense food increases the risk of obesity, which in turn increases the risk of non-communicable diseases, including heart disease, type 2 diabetes and most non-smoking-related cancers. Health warning labels (HWLs) that communicate the adverse health consequences of excess energy consumption could reduce intake of energy-dense foods. The aim of the current study was to estimate the impact on selection of energy-dense snacks of (a) image-and-text HWLs (b) text-only HWLs and (c) calorie information. In a between-subjects, 3 (HWL: image-and-text, text-only, no label) x 2 (calorie information: present, absent), factorial experimental design, participants (N = 4,134) were randomised to view a selection of energy-dense and non-energy-dense snacks with one of five label types or no label. The primary outcome was the proportion of participants selecting an energy-dense snack in a hypothetical vending machine task. The proportion of participants selecting an energy-dense snack was reduced in all label groups, relative to the no label group (no label: 59%; calories only: 54%; text-only HWL: 48%; text-only HWL with calories: 44%; image-and-text HWL: 37%; image-and-text HWL with calories: 38%). Compared to the no label group, participants were least likely to select an energy-dense snack in the image-and-text HWL group (OR = 0.46, 95%CI = 0.40, 0.54, p < 0.001). Health warning labels - particularly those including an image and text - have the potential to reduce selection of energy-dense snacks in an online setting. Their impact on selection and consumption in real-world settings awaits testing.",2020,"The proportion of participants selecting an energy-dense snack was reduced in all label groups, relative to the no label group (no label: 59%; calories only: 54%; text-only HWL: 48%; text-only HWL with calories: 44%; image-and-text HWL: 37%; image-and-text HWL with calories: 38%).","['participants (N\u202f=\u202f4,134', 'snack selection']","['energy-dense snacks of (a) image-and-text HWLs (b) text-only HWLs and (c) calorie information', 'health warning labels', 'energy-dense and non-energy-dense snacks with one of five label types or no label']","['proportion of participants selecting an energy-dense snack', 'proportion of participants selecting an energy-dense snack in a hypothetical vending machine task']","[{'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}]","[{'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0336779', 'cui_str': 'Machine'}]",4134.0,0.0769476,"The proportion of participants selecting an energy-dense snack was reduced in all label groups, relative to the no label group (no label: 59%; calories only: 54%; text-only HWL: 48%; text-only HWL with calories: 44%; image-and-text HWL: 37%; image-and-text HWL with calories: 38%).","[{'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Clarke', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK. Electronic address: ncc42@medschl.cam.ac.uk.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Pechey', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Mantzari', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Anna K M', 'Initials': 'AKM', 'LastName': 'Blackwell', 'Affiliation': 'Tobacco and Alcohol Research Group, School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'De-Loyde', 'Affiliation': 'Tobacco and Alcohol Research Group, School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Morris', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Marcus R', 'Initials': 'MR', 'LastName': 'Munafò', 'Affiliation': 'Tobacco and Alcohol Research Group, School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Marteau', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Gareth J', 'Initials': 'GJ', 'LastName': 'Hollands', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}]",Appetite,['10.1016/j.appet.2020.104744']
3071,32562807,Minimising COVID-19 exposure during tracheal intubation by using a transparent plastic box: a randomised prospective simulation study.,,2020,,[],[],[],[],[],[],,0.0231458,,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Clariot', 'Affiliation': ""Service d'anesthésie-réanimation chirurgicale, DMU CARE, DHU A-TVB, Assistance Publique Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Henri Mondor, F-94010, Créteil, France; Université Paris Est Créteil, Faculté de Santé, F-94010, Créteil, France. Electronic address: simon.clariot@aphp.fr.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Dumain', 'Affiliation': ""Service d'anesthésie-réanimation chirurgicale, DMU CARE, DHU A-TVB, Assistance Publique Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Henri Mondor, F-94010, Créteil, France.""}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Gauci', 'Affiliation': ""Service d'anesthésie-réanimation chirurgicale, DMU CARE, DHU A-TVB, Assistance Publique Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Henri Mondor, F-94010, Créteil, France; Université Paris Est Créteil, Faculté de Santé, F-94010, Créteil, France.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Langeron', 'Affiliation': ""Service d'anesthésie-réanimation chirurgicale, DMU CARE, DHU A-TVB, Assistance Publique Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Henri Mondor, F-94010, Créteil, France; Université Paris Est Créteil, Faculté de Santé, F-94010, Créteil, France; Experimental Neuropathology Unit, Institut Pasteur, 75015, Paris, France.""}, {'ForeName': 'Éric', 'Initials': 'É', 'LastName': 'Levesque', 'Affiliation': ""Service d'anesthésie-réanimation chirurgicale, DMU CARE, DHU A-TVB, Assistance Publique Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Henri Mondor, F-94010, Créteil, France; Université Paris Est Créteil, Faculté de Santé, F-94010, Créteil, France; EA DYNAMYC\u2009Université Paris-Est Créteil (UPEC), École Nationale Vétérinaire d'Alfort (ENVA), Faculté de Santé de Créteil, 8 rue du Général Sarrail, F-94010, Créteil, France.""}]","Anaesthesia, critical care & pain medicine",['10.1016/j.accpm.2020.06.005']
3072,32562877,Efficacy of reslizumab treatment in exacerbation-prone patients with severe eosinophilic asthma.,"BACKGROUND


Patients with severe eosinophilic asthma have increased risk of clinical asthma exacerbations (CAEs), impaired lung function and lower quality of life (QoL) compared with patients with non-eosinophilic asthma. The efficacy and safety of intravenous reslizumab have been demonstrated in two duplicate, randomized, double-blind, placebo-controlled, Phase 3 studies.
OBJECTIVE


We present findings from post hoc analyses of the subgroup of patients from the Phase 3 studies with severe (Global Initiative for Asthma Step 4 or 5) eosinophilic asthma who had ≥2 or ≥3 CAEs in the 12 months prior to screening.
METHODS


Patients aged ≥12 years with severe eosinophilic asthma were randomized (1:1) to reslizumab 3.0 mg/kg or placebo q4w for 1 year. Outcomes assessed included: CAEs, forced expiratory volume in 1 second (FEV 1 ), and Asthma Control Questionnaire 6 (ACQ-6) and Asthma QoL Questionnaire (AQLQ) scores.
RESULTS


Of 953 patients randomized, 318 (reslizumab: n=156; placebo: n=162) and 164 (reslizumab: n=72; placebo: n=92) were GINA 4/5 with ≥2 CAEs in the prior year and ≥3 CAEs in the prior year, respectively. Reslizumab significantly improved CAE rate, time to first CAE, and the proportion of patients who experienced ≥1 CAE versus placebo in both CAE subgroups. Improvements in FEV 1 , ACQ-6 and AQLQ scores, and systemic corticosteroid burden were also observed with reslizumab versus placebo after 52 weeks of treatment in both CAE subgroups.
CONCLUSION


Reslizumab reduced CAE frequency and improved lung function, asthma control and QoL versus placebo in patients with severe eosinophilic asthma with a high CAE rate prior to treatment.",2020,"Improvements in FEV 1 , ACQ-6 and AQLQ scores, and systemic corticosteroid burden were also observed with reslizumab versus placebo after 52 weeks of treatment in both CAE subgroups.
","['exacerbation-prone patients with severe eosinophilic asthma', 'patients with severe eosinophilic asthma with a high CAE rate prior to treatment', '953 patients randomized, 318 (reslizumab: n=156', 'subgroup of patients from the Phase 3 studies with severe (Global Initiative for Asthma Step 4 or 5) eosinophilic asthma who had ≥2 or ≥3 CAEs in the 12 months prior to screening', 'Patients aged ≥12 years with severe eosinophilic asthma', 'Patients with severe eosinophilic asthma', 'patients with non-eosinophilic asthma']","['Reslizumab', 'reslizumab 3.0 mg/kg or placebo', 'reslizumab', 'reslizumab versus placebo', 'placebo']","['CAEs, forced expiratory volume in 1 second (FEV 1 ), and Asthma Control Questionnaire 6 (ACQ-6) and Asthma QoL Questionnaire (AQLQ) scores', 'CAE frequency and improved lung function, asthma control and QoL', 'CAE rate, time to first CAE', 'efficacy and safety', 'FEV 1 , ACQ-6 and AQLQ scores, and systemic corticosteroid burden']","[{'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0034068', 'cui_str': 'Eosinophilic asthma'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0108844', 'cui_str': 'CDE protocol'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1869620', 'cui_str': 'reslizumab'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1869620', 'cui_str': 'reslizumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0108844', 'cui_str': 'CDE protocol'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]",953.0,0.216782,"Improvements in FEV 1 , ACQ-6 and AQLQ scores, and systemic corticosteroid burden were also observed with reslizumab versus placebo after 52 weeks of treatment in both CAE subgroups.
","[{'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Wechsler', 'Affiliation': 'National Jewish Health, Denver, CO, USA. Electronic address: WechslerM@NJHealth.org.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Hickey', 'Affiliation': 'Teva Branded Pharmaceuticals R&D Inc., West Chester, PA, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Garin', 'Affiliation': 'Teva Branded Pharmaceuticals R&D Inc., West Chester, PA, USA.'}, {'ForeName': 'Anoop', 'Initials': 'A', 'LastName': 'Chauhan', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Portsmouth, Hampshire, UK.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.06.009']
3073,32562889,Including Ratio of Platelets to Liver Stiffness Improves Accuracy of Screening for Esophageal Varices That Require Treatment.,"BACKGROUND & AIMS


Based on platelets and liver stiffness measurements, the Baveno VI criteria (B6C), the expanded B6C (EB6C), and the ANTICIPATE score can be used to rule out varices needing treatment (VNT) in patients with compensated chronic liver disease. We aimed to improve these tests by including data on ratio of platelets to liver stiffness.
METHODS


In a retrospective analysis of data from 10 study populations, collected from 2004 through 2018, we randomly assigned data from 2368 patients with chronic liver disease of different etiologies to a derivation population (n=1579; 15.1% with VNT, 50.2% with viral hepatitis, 28.9% with nonalcoholic fatty liver disease, 28.9% with alcohol-associated liver disease, 20.8% with model for end-stage liver disease scores of 9.5±3.0, and 93.0% with liver stiffness measurements ≥10kPa) or a validation population (n=789). Test results were compared with results from a sequential algorithm (VariScreen). VariScreen incorporated data on platelets or liver stiffness measurements and then ratio of platelets to liver stiffness measurement, adjusted for etiology, patient sex, and international normalized ratio.
RESULTS


In the derivation population, endoscopies were spared for 23.9% of patients using the B6C (VNTs missed in 2.9%), 24.3% of patients using the ANTICIPATE score (VNTs missed in 4.6%), 34.5% of patients using VariScreen (VNTs missed in 2.9%), and 41.9% of patients using the EB6C (VNTs missed in 10.9%). Differences in spared endoscopy rates were significant (P≤.001) except for B6C vs ANTICIPATE and in missed VNT only for EB6C vs the others (P≤.009). VariScreen was the only safe test regardless of sex or etiology (missed VNT ≤5%). Moreover, VariScreen secured screening without missed VNT in patients with model for end-stage liver disease scores >10. This overall strategy performed better than a selective strategy restricted to patients with compensated liver disease. Test performance and safety did not differ significantly among populations.
CONCLUSIONS


In a retrospective study of data from 2368 patients with chronic liver disease, we found that the B6C are safe whereas the EB6C are unsafe, based on missed VNT. The VariScreen algorithm performed well in patients with chronic liver disease of any etiology or severity-it is the only test that safely rules out VNTs and can be used in clinical practice.",2020,Differences in spared endoscopy rates were significant (P≤.001) except for B6C vs ANTICIPATE and in missed VNT only for EB6C vs the others (P≤.009).,"['Esophageal Varices', 'patients with chronic liver disease of any etiology or severity', '10 study populations, collected from 2004 through 2018, we randomly assigned data from 2368 patients with chronic liver disease of different etiologies to a derivation population (n=1579; 15.1% with VNT, 50.2% with viral hepatitis, 28.9% with nonalcoholic fatty liver disease, 28.9% with alcohol-associated liver disease, 20.8% with model for end-stage liver disease scores of 9.5±3.0, and 93.0% with liver stiffness measurements ≥10kPa) or a validation population (n=789', 'patients with compensated liver disease', '2368 patients with chronic liver disease', 'patients with compensated chronic liver disease']",[],"['spared endoscopy rates', 'Test performance and safety']","[{'cui': 'C0014867', 'cui_str': 'Esophageal varices'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0341439', 'cui_str': 'Chronic liver disease'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042721', 'cui_str': 'Viral hepatitis'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C4048785', 'cui_str': 'Model for end stage liver disease score'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C3839044', 'cui_str': 'Compensated liver disease'}]",[],"[{'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",2368.0,0.03324,Differences in spared endoscopy rates were significant (P≤.001) except for B6C vs ANTICIPATE and in missed VNT only for EB6C vs the others (P≤.009).,"[{'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Berger', 'Affiliation': 'Hepato-Gastroenterology Department, University Hospital, Angers, France; HIFIH laboratory, UPRES 3859, UNIV Angers, France.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Ravaioli', 'Affiliation': 'Gastroenterology and Hepatology Unit, Department of Medical and Surgical Sciences (DIMEC), University of Bologna, Bologna, Italy.'}, {'ForeName': 'Oana', 'Initials': 'O', 'LastName': 'Farcau', 'Affiliation': 'Liver Unit, Regional Institute of Gastroenterology and Hepatology, Cluj-Napoca, Romania.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Festi', 'Affiliation': 'Gastroenterology and Hepatology Unit, Department of Medical and Surgical Sciences (DIMEC), University of Bologna, Bologna, Italy.'}, {'ForeName': 'Horia', 'Initials': 'H', 'LastName': 'Stefanescu', 'Affiliation': 'Liver Unit, Regional Institute of Gastroenterology and Hepatology, Cluj-Napoca, Romania.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Buisson', 'Affiliation': 'Hepato-Gastroenterology Department, University Hospital, Angers, France; HIFIH laboratory, UPRES 3859, UNIV Angers, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Nahon', 'Affiliation': 'Hepato-Gastroenterology Department, Paris Seine-Saint-Denis University Hospitals, APHP, Jean Verdier Hospital, Bondy; University Paris 13, Bobigny; INSERM UMR 1162, Paris, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Bureau', 'Affiliation': 'Hepato-Gastroenterology Department, Purpan University Hospital, Toulouse, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Ganne-Carriè', 'Affiliation': 'Hepato-Gastroenterology Department, Paris Seine-Saint-Denis University Hospitals, APHP, Jean Verdier Hospital, Bondy; University Paris 13, Bobigny; INSERM UMR 1162, Paris, France.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Berzigotti', 'Affiliation': 'Hepatology, Swiss Liver Center, Visceral Surgery and Medicine Clinic (UVCM), Inselspital, University of Bern, Switzerland.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'de Ledinghen', 'Affiliation': 'Hepatology Department, Haut-Lévêque Hospital, Bordeaux, France.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Petta', 'Affiliation': 'Department of Gastroenterology and Hepatology, PROMISE, University of Palermo, Palermo, Italy.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Calès', 'Affiliation': 'Hepato-Gastroenterology Department, University Hospital, Angers, France; HIFIH laboratory, UPRES 3859, UNIV Angers, France. Electronic address: paul.cales@univ-angers.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.06.022']
3074,32445215,Comparative clinical study on microwave ablation combined with gemcitabine and cisplatin or combined with pemetrexed and cisplatin in treatment of advanced NSCLC.,"OBJECTIVE


Solving the limitations of single chemotherapy in the treatment of non-small cell lung cancer (NSCLC).
METHODS


About 100 patients with NSCLC treated in First Hospital of Jiaxing, Zhejiang from June 2016 to June 2018 were selected and randomly divided into MPC group and MGC group, with 50 cases in each group. The patients in MPC group were treated with microwave ablation (MWA) combined with PC while patients in MGC group were given MWA combined with gemcitabine plus cisplatin (GC). The therapeutic effects of the two groups as well as the complications and adverse reactions (ADRs) were observed and recorded.
RESULTS


There was no significant difference in disease response rate (MPC group 33.3% vs MGC group 32.0%), disease control rate (MPC group 86.4% vs MGC group 78.0%) and overall survival (1-, 2- and 3-year survival, MPC group 65%, 59%, 32.7% vs MGC group 58%, 46%, 30%) between the two groups. In addition, the ADR myelosuppression was slighter in MPC group. There were 12 cases (23%) developed myelosuppression in the MPC group and 20 cases (42%) in MGC group, with a significant difference between the two groups (P < 0.05). The treatment was interrupted for 0 case (0%) in MPC group because of myelosuppression while 4 cases (8.3%) in MGC group.
CONCLUSION


The two therapeutic regimens have similar efficacy in treatment of advanced NSCLC, but MPC causes slighter myelosuppression and can be the first-line therapy for advanced NSCLC.",2020,"There was no significant difference in disease response rate (MPC group 33.3% vs. MGC group 32.0%), disease control rate (MPC group 86.4% vs. MGC group 78.0%) and overall survival (","['100 patients with NSCLC treated in First Hospital of Jiaxing, Zhejiang from June 2016 to June 2018', 'non-small cell lung cancer (NSCLC', 'advanced NSCLC']","['cisplatin plus gemcitabine or pemetrexed', 'single chemotherapy', 'MPC group and MGC', 'MWA combined with GC', 'MWA combined with PC']","['complications and ADRs', 'disease control rate', '1-, 2- and 3-year survival', 'overall survival', 'disease response rate', 'ADR myelosuppression', 'myelosuppression']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression'}]",100.0,0.0331002,"There was no significant difference in disease response rate (MPC group 33.3% vs. MGC group 32.0%), disease control rate (MPC group 86.4% vs. MGC group 78.0%) and overall survival (","[{'ForeName': 'YingQing', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory Medicine, The First Hospital of Jiaxing, Affiliated Hospital of Jiaxing University, Jiaxing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Department of Respiratory Medicine, The First Hospital of Jiaxing, Affiliated Hospital of Jiaxing University, Jiaxing, China.'}, {'ForeName': 'YongLei', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Respiratory Medicine, The First Hospital of Jiaxing, Affiliated Hospital of Jiaxing University, Jiaxing, China.'}, {'ForeName': 'YingXin', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Respiratory Medicine, The First Hospital of Jiaxing, Affiliated Hospital of Jiaxing University, Jiaxing, China.'}, {'ForeName': 'LinLan', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation, The First Hospital of Jiaxing, Affiliated Hospital of Jiaxing University, Jiaxing, China.'}]",The clinical respiratory journal,['10.1111/crj.13219']
3075,32442334,Early 3-month treatment with comprehensive physical therapy program restores continence in urinary incontinence patients after radical prostatectomy: A randomized controlled trial.,"AIMS


The objective of this study is to ascertain whether an early three-month treatment with electrotherapy and biofeedback restores continence in urinary incontinence patients after radical prostatectomy (RP).
METHODS


Design: The study performed a randomized, controlled trial of parallel and open groups. Configuration: Secondary care, urology department of a university hospital complex.
PARTICIPANTS


Patients sent for RP due to prostate cancer (n = 60), 47 patients finally completed the study.
INTERVENTIONS


The treatment group (TG) received physiotherapy consisting of electrotherapy and biofeedback, 3 days a week for 3 months, while the control group (CG) received no specific treatment. Both groups received a guide to perform pelvic floor exercises at home. The measurement instruments used were the 1- and 24-hour pad tests and the International Consultation on Incontinence Questionnaire Short-Form. The recording method used was a micturition (urinary) diary.
RESULTS


The results of the 1-hour pad test (PT) show statistically significant differences between groups at 3 months (P = .001) and 6 months (P = .001), in favor of those in the TG. Sixty-four percent of patients in the TG recovered continence as against 9.1% in the CG after 3 months in the 1-hour PT, in line with the objective of this study.
CONCLUSIONS


An early physiotherapy program helps RP patients with urinary incontinence recover continence after 3 months. Moreover, they lead a better quality life.",2020,"Sixty-four percent of patients in the TG recovered continence as against 9.1% in the CG after 3 months in the 1-hour PT, in line with the objective of this study.
","['urinary incontinence patients after radical prostatectomy', 'Patients sent for RP\xa0due to prostate cancer (n\u2009=\u200960), 47 patients finally completed the study', 'urinary incontinence patients after radical prostatectomy (RP']","['Configuration', 'guide to perform pelvic floor exercises at home', 'physiotherapy program', 'control group (CG) received no specific treatment', 'comprehensive physical therapy program restores continence', 'electrotherapy and biofeedback restores continence', 'physiotherapy consisting of electrotherapy\xa0and biofeedback']","['quality life', 'urinary incontinence recover continence']","[{'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0262718', 'cui_str': 'Pelvic floor exercises'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0013787', 'cui_str': 'Electrotherapy'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}]",,0.0525782,"Sixty-four percent of patients in the TG recovered continence as against 9.1% in the CG after 3 months in the 1-hour PT, in line with the objective of this study.
","[{'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Soto González', 'Affiliation': 'Department of Functional Biology and Health Sciences, Faculty of Physiotherapy, University of Vigo, Vigo, Spain.'}, {'ForeName': 'Iria', 'Initials': 'I', 'LastName': 'Da Cuña Carrera', 'Affiliation': 'Department of Functional Biology and Health Sciences, Faculty of Physiotherapy, University of Vigo, Vigo, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Gutiérrez Nieto', 'Affiliation': 'Department of Functional Biology and Health Sciences, Faculty of Physiotherapy, University of Vigo, Vigo, Spain.'}, {'ForeName': 'Sabela', 'Initials': 'S', 'LastName': 'López García', 'Affiliation': 'Urology Service, University Hospital Complex of Vigo, Vigo, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ojea Calvo', 'Affiliation': 'Urology Service, University Hospital Complex of Vigo, Vigo, Spain.'}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Lantarón Caeiro', 'Affiliation': 'Department of Functional Biology and Health Sciences, Faculty of Physiotherapy, University of Vigo, Vigo, Spain.'}]",Neurourology and urodynamics,['10.1002/nau.24389']
3076,32450720,Five-year results of viscotrabeculotomy versus conventional trabeculotomy in primary congenital glaucoma: A randomized controlled study.,"PURPOSE


To assess the long-term results of viscotrabeculotomy in infants with primary congenital glaucoma and to compare its outcome with conventional trabeculotomy.
PATIENTS AND METHODS


A prospective randomized comparative study included infants with primary congenital glaucoma younger than 2 years. Patients were divided into two groups: viscotrabeculotomy group and conventional trabeculotomy group. Preoperative and postoperative intraocular pressures, corneal diameter, intraoperative and postoperative complications, and success rates were compared between two groups. All the patients were followed up for 5 years.
RESULTS


The study included 154 eyes of 92 infants distributed randomly among the two groups; 78 and 76 eyes in viscotrabeculotomy and conventional trabeculotomy groups, respectively. In both groups, there was a statistically significant intraocular pressure reduction at all time points of the follow-up periods compared to the preoperative values (p < 0.0001). At 5 years, viscotrabeculotomy group showed significant reduction of the mean postoperative intraocular pressure (49.47%) than conventional trabeculotomy group (48.64%) (p < 0.0001). Intraocular pressure was statistically lower in viscotrabeculotomy starting from 12th month and till the end of the follow-up. At 5 years, the total success rate of viscotrabeculotomy group was 89.74% compared to 85.53% in conventional trabeculotomy group without significant difference (p = 0.487). The postoperative mean values of the cup/disk ratio in viscotrabeculotomy group showed statistically lower values compared to conventional trabeculotomy group (p = 0.019). Postoperative hyphema was statistically higher in conventional trabeculotomy group (p < 0.0001). All eyes that underwent a reoperation before 5 years follow-up were excluded from the statistical workup of the study after reoperation, except for calculation of success/failure.
CONCLUSION


Viscotrabeculotomy and conventional trabeculotomy proved to be effective in cases of primary congenital glaucoma. Viscotrabeculotomy appeared to have prolonged stability in controlling the intraocular pressure with higher success rates and lower complications.",2020,Viscotrabeculotomy appeared to have prolonged stability in controlling the intraocular pressure with higher success rates and lower complications.,"['infants with primary congenital glaucoma younger than 2 years', '154 eyes of 92 infants distributed randomly among the two groups; 78 and 76 eyes in', 'primary congenital glaucoma', 'infants with primary congenital glaucoma']","['conventional trabeculotomy', 'viscotrabeculotomy and conventional trabeculotomy', 'Viscotrabeculotomy and conventional trabeculotomy', 'Viscotrabeculotomy', 'viscotrabeculotomy group and conventional trabeculotomy group', 'viscotrabeculotomy']","['intraocular pressure reduction', 'Postoperative hyphema', 'postoperative mean values of the cup/disk ratio', 'Preoperative and postoperative intraocular pressures, corneal diameter, intraoperative and postoperative complications, and success rates', 'mean postoperative intraocular pressure', 'Intraocular pressure', 'total success rate']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1533041', 'cui_str': 'Primary congenital glaucoma'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0040576', 'cui_str': 'Trabeculotomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0020581', 'cui_str': 'Hyphema'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0429514', 'cui_str': 'Corneal diameter'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",154.0,0.0433806,Viscotrabeculotomy appeared to have prolonged stability in controlling the intraocular pressure with higher success rates and lower complications.,"[{'ForeName': 'Ahmed S', 'Initials': 'AS', 'LastName': 'Elwehidy', 'Affiliation': 'Ophthalmology Department, Ophthalmic Center, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Sherein M', 'Initials': 'SM', 'LastName': 'Hagras', 'Affiliation': 'Ophthalmology Department, Ophthalmic Center, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Bayoumi', 'Affiliation': 'Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Ayman E', 'Initials': 'AE', 'LastName': 'AbdelGhafar', 'Affiliation': 'Ophthalmology Department, Ophthalmic Center, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Amani E', 'Initials': 'AE', 'LastName': 'Badawi', 'Affiliation': 'Ophthalmology Department, Ophthalmic Center, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}]",European journal of ophthalmology,['10.1177/1120672120922453']
3077,32452128,Spironolactone dose in heart failure with preserved ejection fraction: findings from TOPCAT.,"AIMS


Spironolactone up-titration may be limited by side effects that could be minimized at lower than target doses, but whether lower than target doses remain efficacious is unknown. In TOPCAT, spironolactone (or placebo) were started at 15 mg/day, and increased up to a maximum of 45 mg/day. The prognostic implications related to spironolactone dose are yet to be reported. We aimed to assess the average spironolactone/placebo doses provided during the trial, overall and within high-risk subgroups (e.g. elderly, renal dysfunction, high potassium); discontinuation rates; and the efficacy of lower than target doses in heart failure with preserved ejection fraction.
METHODS AND RESULTS


Overall, 1767 patients from 'TOPCAT-Americas' were included. Linear, logistic and Cox regressions were applied. Patients randomized to spironolactone received lower doses than placebo: 22.5 (15.0-27.5) mg/day vs. 27.5 (17.5-27.5) mg/day (P < 0.001). Patients aged ≥75 years, with an estimated glomerular filtration rate ≤60 mL/min/1.73 m 2  , and with potassium levels >4.5 mmol/L, received lower spironolactone doses (median ≈ 20 mg/day). This pattern of dose differences was not observed in patients taking placebo, where the between-subgroup placebo doses were similar (spironolactone-placebo by subgroup P interaction   < 0.05). Among patients taking spironolactone, 25.4% discontinued the drug during the first year, compared with 18.3% of the patients taking placebo (P < 0.001). Discontinuation rates in the aforementioned high-risk subgroups reached 30% during the first year. Spironolactone reduced the primary outcome of heart failure hospitalization/cardiovascular death without significant heterogeneity between the study subgroups (P interaction   > 0.1). Spironolactone discontinuation was associated with a two to fourfold higher risk of subsequent events.
CONCLUSION


Spironolactone (but not placebo) was used at lower doses among the elderly, those with renal dysfunction and with higher potassium levels. The effect of spironolactone was homogeneous across these subgroups. In patients unable to tolerate target doses, a low-dose strategy should be preferred to stopping treatment.",2020,Spironolactone reduced the primary outcome of HFH/CVD without significant heterogeneity between the studied subgroups (interaction p  > 0.1).,"['1767 patients from ""TOPCAT-Americas"" were included', 'Patients', 'Heart Failure with Preserved Ejection Fraction']","['spironolactone', 'Spironolactone', 'spironolactone-placebo', 'spironolactone/placebo', 'TOPCAT, spironolactone (or placebo', 'placebo']","['discontinuation rates', 'HFH/CVD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002454', 'cui_str': 'America'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}]","[{'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]",1767.0,0.207414,Spironolactone reduced the primary outcome of HFH/CVD without significant heterogeneity between the studied subgroups (interaction p  > 0.1).,"[{'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': ""Université de Lorraine, Centre d'Investigation Clinique-Plurithématique, CHRU Nancy, INSERM U1116, and FCRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Rossello', 'Affiliation': 'Department of Cardiology, Centro Nacional de Investigaciones Cardiovasculares Carlos III, Madrid, Spain.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Pocock', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': ""Université de Lorraine, Centre d'Investigation Clinique-Plurithématique, CHRU Nancy, INSERM U1116, and FCRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France.""}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Jean-Lucien', 'Initials': 'JL', 'LastName': 'Rouleau', 'Affiliation': 'Montreal Heart Institute, Montreal, Canada.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': 'Department of Medicine, University of Michigan School of Medicine, Ann Arbor, MI, USA.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Pfeffer', 'Affiliation': ""Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""Université de Lorraine, Centre d'Investigation Clinique-Plurithématique, CHRU Nancy, INSERM U1116, and FCRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France.""}]",European journal of heart failure,['10.1002/ejhf.1909']
3078,32563116,Screening and brief intervention for lower-risk drug use in primary care: A pilot randomized trial.,"AIMS


The efficacy of screening and brief intervention for lower-risk drug use is unknown. This pilot study tested the efficacy of two brief interventions (BIs) for drug use compared to no BI in primary care patients with lower-risk drug use identified by screening.
METHODS


We randomly assigned participants identified by screening with Alcohol Smoking and Substance Involvement Screening Test (ASSIST) drug specific scores of 2 or 3 to: no BI, a brief negotiated interview (BNI), or an adaptation of motivational interviewing (MOTIV). Primary outcome was number of days use of main drug in the past 30 as determined by validated calendar method at 6 months. Analyses were performed using negative binomial regression adjusted for baseline use and main drug.
RESULTS


Of 142 eligible adults, 61(43 %) consented and were randomized. Participant characteristics were: mean age 41; 54 % male; 77 % black. Main drug was cannabis 70 %, cocaine 15 %, prescription opioid 10 %; 7% reported injection drug use and mean days use of main drug (of 30) was 3.4. At 6 months, 93 % completed follow-up and adjusted mean days use of main drug were 6.4 (no BI) vs 2.1 (BNI) (incidence rate ratio, IRR 0.33[0.15-0.74]) and 2.3 (MOTIV) (IRR 0.36[0.15-0.85]).
CONCLUSIONS


BI appears to have efficacy for preventing an increase in drug use in primary care patients with lower-risk use identified by screening. These findings raise the potential that less severe patterns of drug use in primary care may be uniquely amenable to brief intervention and warrant replication.",2020,"This pilot study tested the efficacy of two brief interventions (BIs) for drug use compared to no BI in primary care patients with lower-risk drug use identified by screening.
","['Of 142 eligible adults, 61(43 %) consented and were randomized', 'Participant characteristics were: mean age 41; 54 % male; 77 % black', 'lower-risk drug use in primary care', 'primary care patients with lower-risk drug use identified by screening', 'primary care patients with lower-risk use identified by screening']","['brief interventions (BIs', 'screening with Alcohol Smoking and Substance Involvement Screening Test (ASSIST) drug specific scores of 2 or 3 to: no BI, a brief negotiated interview (BNI), or an adaptation of motivational interviewing (MOTIV', 'screening and brief intervention']",['number of days use of main drug in the past 30 as determined by validated calendar method'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0680727', 'cui_str': 'Mediation'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0035513', 'cui_str': 'Contraceptive rhythm method'}]",142.0,0.0558587,"This pilot study tested the efficacy of two brief interventions (BIs) for drug use compared to no BI in primary care patients with lower-risk drug use identified by screening.
","[{'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bertholet', 'Affiliation': 'Addiction Medicine, Department of Psychiatry, Lausanne University Hospital and University of Lausanne, Bugnon 23A, Lausanne, 1011, Switzerland. Electronic address: Nicolas.Bertholet@chuv.ch.'}, {'ForeName': 'Seville', 'Initials': 'S', 'LastName': 'Meli', 'Affiliation': 'Upstream USA, Cambridge, MA 02140, USA.'}, {'ForeName': 'Tibor P', 'Initials': 'TP', 'LastName': 'Palfai', 'Affiliation': 'Department of Psychology, Boston University, 900 Commonwealth Avenue, Boston, MA 02215, USA. Electronic address: palfai@bu.edu.'}, {'ForeName': 'Debbie M', 'Initials': 'DM', 'LastName': 'Cheng', 'Affiliation': 'Department of Biostatistics, Boston University School of Public Health, Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine, and the Grayken Center for Addiction, Boston Medical Center and Boston University School of Medicine, Boston, MA 02118, USA. Electronic address: dmcheng@bu.edu.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Alford', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine, and the Grayken Center for Addiction, Boston Medical Center and Boston University School of Medicine, Boston, MA 02118, USA. Electronic address: Dan.Alford@bmc.org.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Bernstein', 'Affiliation': 'Department of Community Health Sciences, Boston University School of Public Health, Boston, MA 02118, USA. Electronic address: jbernste@bu.edu.'}, {'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Samet', 'Affiliation': 'Department of Community Health Sciences, Boston University School of Public Health, Boston, MA, USA, and Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine, and the Grayken Center for Addiction, Boston Medical Center and Boston University School of Medicine, Boston, MA 02118, USA. Electronic address: jsamet@bu.edu.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lloyd-Travaglini', 'Affiliation': 'Data Coordinating Center, Boston University School of Public Health, Boston, MA 02118, USA. Electronic address: clloyd@bu.edu.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Saitz', 'Affiliation': 'Department of Community Health Sciences, Boston University School of Public Health, Boston, MA, USA, and Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine, and the Grayken Center for Addiction, Boston Medical Center and Boston University School of Medicine, Boston, MA 02118, USA. Electronic address: rsaitz@bu.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108001']
3079,32563171,Adjunctive perampanel and myoclonic and absence seizures: Post hoc analysis of data from study 332 in patients with idiopathic generalized epilepsy.,"PURPOSE


This post hoc analysis assessed the effects of adjunctive perampanel on myoclonic and absence seizure outcomes in patients (aged ≥12 years) with idiopathic generalized epilepsy (IGE) and generalized tonic-clonic seizures during the double-blind (up to 8 mg/day) and open-label extension (OLEx; up to 12 mg/day) phases of Study 332.
METHODS


Patients experiencing myoclonic and/or absence seizures during study baseline were included. Assessments for myoclonic and absence seizures included: median percent change in seizure frequency, number of seizure days and seizure-free days (all per 28 days), 50 % and 75 % responder rates, seizure-freedom rates, seizure worsening, and monitoring of treatment-emergent adverse events (TEAEs).
RESULTS


During the double-blind phase, myoclonic and/or absence seizures were reported in 47/163 and 60/163 patients, respectively. Median percent reductions in seizure frequency per 28 days from study baseline were 52.5% and 24.5% (myoclonic seizures) and 7.6 % and 41.2 % (absence seizures) for placebo and perampanel, respectively; seizure-freedom rates were 13.0 % and 16.7 % (myoclonic seizures) and 12.1 % and 22.2 % (absence seizures), respectively. During the OLEx phase, 46/138 and 52/138 patients experienced myoclonic and/or absence seizures, respectively. Responses during the double-blind phase were maintained during long-term (>104 weeks) adjunctive perampanel treatment. The frequency/type of TEAEs was consistent with the known safety profile of perampanel.
CONCLUSION


In this post hoc analysis, adjunctive perampanel was not associated with any overall worsening of absence seizures. Further research is needed to investigate the effect of adjunctive perampanel in IGE patients with myoclonic and/or absence seizures.",2020,"In this post hoc analysis, adjunctive perampanel was not associated with any overall worsening of absence seizures.","['and myoclonic and absence seizures', 'patients (aged ≥12 years) with idiopathic generalized epilepsy (IGE) and generalized tonic-clonic seizures during the double-blind (up to 8 mg/day) and open-label extension (OLEx; up to 12 mg/day) phases of Study 332', 'Patients experiencing myoclonic and/or absence seizures during study baseline were included', 'patients with idiopathic generalized epilepsy', 'IGE patients with myoclonic and/or absence seizures']","['Adjunctive perampanel', 'adjunctive perampanel', 'placebo']","['responder rates, seizure-freedom rates, seizure worsening, and monitoring of treatment-emergent adverse events (TEAEs', 'seizure frequency', 'overall worsening of absence seizures', 'myoclonic and/or absence seizures', 'seizure frequency, number of seizure days and seizure-free days', 'seizure-freedom rates', 'myoclonic and absence seizure outcomes']","[{'cui': 'C0014553', 'cui_str': 'Absence seizure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0270850', 'cui_str': 'Idiopathic generalized epilepsy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0494475', 'cui_str': 'Tonic-clonic seizure'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C2698764', 'cui_str': 'perampanel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0014553', 'cui_str': 'Absence seizure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1299590', 'cui_str': 'Seizure free'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.383148,"In this post hoc analysis, adjunctive perampanel was not associated with any overall worsening of absence seizures.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Brandt', 'Affiliation': 'Bethel Epilepsy Centre, Maraweg 21, 33617, Bielefeld, Germany. Electronic address: Christian.Brandt@mara.de.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Wechsler', 'Affiliation': 'Idaho Comprehensive Epilepsy Center, 1499 West Hays St., Boise, ID, 83702, USA. Electronic address: rtw@idahoepilepsy.com.'}, {'ForeName': 'Terence J', 'Initials': 'TJ', 'LastName': ""O'Brien"", 'Affiliation': 'The Department of Neuroscience, The Central Clinical School, Monash University, The Alfred Centre, 99 Commercial Road, Melbourne, VIC, 3004, Australia; The Departments of Medicine, The Royal Melbourne Hospital, The University of Melbourne, Grattan St., Parkville, VIC, 3010, Australia. Electronic address: terence.obrien@monash.edu.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Patten', 'Affiliation': 'Eisai Ltd., Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, UK. Electronic address: Anna_Patten@eisai.net.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Malhotra', 'Affiliation': 'Eisai Inc., 100 Tice Blvd, Woodcliff Lake, NJ, 07677, USA. Electronic address: Manoj_Malhotra@eisai.com.'}, {'ForeName': 'Leock Y', 'Initials': 'LY', 'LastName': 'Ngo', 'Affiliation': 'Eisai Inc., 100 Tice Blvd, Woodcliff Lake, NJ, 07677, USA. Electronic address: Stella_Ngo@eisai.com.'}, {'ForeName': 'Bernhard J', 'Initials': 'BJ', 'LastName': 'Steinhoff', 'Affiliation': 'Kork Epilepsy Centre, Landstraße 1, 77694, Kehl-Kork, Germany. Electronic address: BSteinhoff@epilepsiezentrum.de.'}]",Seizure,['10.1016/j.seizure.2020.06.011']
3080,32563173,Impact of childhood adversity on network reconfiguration dynamics during working memory in hypogonadal women.,"Many women with no history of cognitive difficulties experience executive dysfunction during menopause. Significant adversity during childhood negatively impacts executive function into adulthood and may be an indicator of women at risk of a mid-life cognitive decline. Previous studies have indicated that alterations in functional network connectivity underlie these negative effects of childhood adversity. There is growing evidence that functional brain networks are not static during executive tasks; instead, such networks reconfigure over time. Optimal dynamics are necessary for efficient executive function; while too little reconfiguration is insufficient for peak performance, too much reconfiguration (supra-optimal reconfiguration) is also maladaptive and associated with poorer performance. Here we examined the impact of adverse childhood experiences (ACEs) on network flexibility, a measure of dynamic reconfiguration, during a letter n-back task within three networks that support executive function: frontoparietal, salience, and default mode networks. Several animal and human subject studies have suggested that childhood adversity exerts lasting effects on executive function via serotonergic mechanisms. Tryptophan depletion (TD) was used to examine whether serotonin function drives ACE effects on network flexibility. We hypothesized that ACE would be associated with higher flexibility (supra-optimal flexibility) and that TD would further increase this measure. Forty women underwent functional imaging at two time points in this double-blind, placebo controlled, crossover study. Participants also completed the Penn Conditional Exclusion Test, a task assessing abstraction and mental flexibility. The effects of ACE and TD were evaluated using generalized estimating equations. ACE was associated with higher flexibility across networks (frontoparietal β = 0.00748, D = 2.79, p = 0.005; salience β = 0.00679, D = 3.02, p = 0.003; and default mode β = 0.00910, D = 3.53, p = 0.0004). While there was no interaction between ACE and TD, active TD increased network flexibility in both ACE groups in comparison to sham depletion (frontoparietal β = 0.00489, D = 2.15, p = 0.03; salience β = 0.00393, D = 1.91, p = 0.06; default mode β = 0.00334, D = 1.73, p = 0.08). These results suggest that childhood adversity has lasting impacts on dynamic reconfiguration of functional brain networks supporting executive function and that decreasing serotonin levels may exacerbate these effects.",2020,"While there was no interaction between ACE and TD, active TD increased network flexibility in both ACE groups in comparison to sham depletion (frontoparietal β = 0.00489, D =","['Forty women underwent', 'hypogonadal women', 'Many women with no history of cognitive difficulties experience executive dysfunction during menopause']","['ACE', 'Tryptophan depletion (TD', 'functional imaging', 'placebo']","['ACE and TD, active TD increased network flexibility']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C2748208', 'cui_str': 'Executive dysfunction'}, {'cui': 'C0587112', 'cui_str': 'During menopause'}]","[{'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",40.0,0.0712399,"While there was no interaction between ACE and TD, active TD increased network flexibility in both ACE groups in comparison to sham depletion (frontoparietal β = 0.00489, D =","[{'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Shanmugan', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA; Penn PROMOTES Research on Sex and Gender in Health, University of Pennsylvania, Philadelphia, PA, USA. Electronic address: sheilashanmugan@gmail.com.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Cao', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Theodore D', 'Initials': 'TD', 'LastName': 'Satterthwaite', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Mary D', 'Initials': 'MD', 'LastName': 'Sammel', 'Affiliation': 'Penn PROMOTES Research on Sex and Gender in Health, University of Pennsylvania, Philadelphia, PA, USA; Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA; Obstetrics and Gynecology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Arian', 'Initials': 'A', 'LastName': 'Ashourvan', 'Affiliation': 'Department of Bioengineering, University of Pennsylvania, Philadelphia, PA, USA; Department of Neurology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Danielle S', 'Initials': 'DS', 'LastName': 'Bassett', 'Affiliation': 'Department of Bioengineering, University of Pennsylvania, Philadelphia, PA, USA; Department of Neurology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA; Department of Physics & Astronomy, University of Pennsylvania, Philadelphia, PA, USA; Department of Electrical & Systems Engineering, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Kosha', 'Initials': 'K', 'LastName': 'Ruparel', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Ruben C', 'Initials': 'RC', 'LastName': 'Gur', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'C Neill', 'Initials': 'CN', 'LastName': 'Epperson', 'Affiliation': 'Department of Psychiatry, Anschutz Medical Campus, University of Colorado, Aurora, CO USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Loughead', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104710']
3081,32563179,The effects of the iPlayClean education programme on doping attitudes and susceptibility to use banned substances among high-level adolescent athletes from the UK: A cluster-randomised controlled trial.,"Background This study examined the effects of the iPlayClean anti-doping intervention on attitudes towards doping and susceptibility, and whether delivery mode affected the results. Methods A total of 1081 high-level UK athletes (14-18 years old, 904 males, 177 females) were cluster-randomised to the control (11 teams/organisations/schools, 314 athletes), face-to-face group presentation (8 teams/organisations/schools, 254 athletes), online (11 teams/organisations/schools, 251 athletes), or face-to-face presentation with online access (5 teams/organisations/schools, 262 athletes). Results Compared to the control group, all modes of the iPlayClean anti-doping education programme reduced favourable attitudes towards doping immediately after the intervention, which was sustained across all intervention groups 8 weeks later. All delivery modes impacted doping susceptibility immediately after the intervention, in comparison to the control group, but the effects were only sustained for the face-to-face presentation group. Conclusion Contrary to findings within previous anti-doping interventions, we have shown that doping attitudes can be changed and that the results can be sustained across all modes of delivery, 8 weeks later. Research is required to assess for how long these changes are sustained, and how often anti-doping education should be delivered to high-level athletes to reinforce clean play values.",2020,"Compared to the control group, all modes of the iPlayClean anti-doping education programme reduced favourable attitudes towards doping immediately after the intervention, which was sustained across all intervention groups 8 weeks later.","['1081 high-level UK athletes (14-18 years old, 904 males, 177 females) were cluster-randomised to the control (11 teams/organisations/schools, 314 athletes), face-to-face group presentation (8 teams/organisations/schools, 254 athletes), online (11 teams/organisations/schools, 251 athletes), or face-to-face presentation with online access (5 teams/organisations/schools, 262 athletes', 'high-level adolescent athletes from the UK']","['iPlayClean anti-doping intervention', 'iPlayClean education programme']",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0233269', 'cui_str': 'Face presentation'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0013039', 'cui_str': 'Doping in Sports'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]",[],1081.0,0.0185148,"Compared to the control group, all modes of the iPlayClean anti-doping education programme reduced favourable attitudes towards doping immediately after the intervention, which was sustained across all intervention groups 8 weeks later.","[{'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Nicholls', 'Affiliation': 'Department of Sport, Health, and Exercise Science, University of Hull, Cottingham Road, Hull HU6 7RX, UK. Electronic address: A.Nicholls@hull.ac.uk.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Morley', 'Affiliation': 'Department of Dietetics, Nutrition, and Sport, La Trobe University, Melbourne 3086 VIC, Australia.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Thompson', 'Affiliation': 'Department of Sport, Health, and Exercise Science, University of Hull, Cottingham Road, Hull HU6 7RX, UK.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Hull York Medical School, University of Hull, Cottingham Road, Hull HU6 7RX, UK.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Abt', 'Affiliation': 'Department of Sport, Health, and Exercise Science, University of Hull, Cottingham Road, Hull HU6 7RX, UK.'}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Rothwell', 'Affiliation': 'Academy of Sport and Physical Activity, Sheffield Hallam University, Howard St, Sheffield S1 1WB, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Cope', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Espinal Way, Loughborough LE11 3TU, UK.'}, {'ForeName': 'Nikos', 'Initials': 'N', 'LastName': 'Ntoumanis', 'Affiliation': 'Physical Activity and Well-Being Research Group,(,) School of Psychology, Curtin University, Kent St, Bentley, WA 6102, Australia.'}]",The International journal on drug policy,['10.1016/j.drugpo.2020.102820']
3082,32442673,Salivary oxytocin after oxytocin administration: Examining the moderating role of childhood trauma.,"Although oxytocin administration influences behavior, its effects on peripheral oxytocin concentrations are mixed and derived from studies on healthy subjects. Additionally, trauma attenuates the behavioral effects of oxytocin, but it is unknown whether it also influences its effect on peripheral circulation. This study examined whether salivary oxytocin increased after oxytocin administration and whether trauma attenuated this effect. We conducted a randomized, double-blind, placebo-controlled, within-subjects study in 100 male adolescents living in residential youth care facilities. Participants self-administered intranasally 24 IU of oxytocin and placebo (one week later) and provided a saliva sample before and 15 min after administration. Salivary oxytocin increased significantly after oxytocin administration, but this effect might be inflated by exogenous oxytocin reaching the throat. Trauma did not moderate this effect. Our findings suggest that trauma did not attenuate the effect of oxytocin administration on salivary oxytocin, but more robust methodologies are recommended to draw more solid conclusions.",2020,Trauma did not moderate this effect.,"['100 male adolescents living in residential youth care facilities', 'healthy subjects']","['oxytocin', 'salivary oxytocin', 'Salivary oxytocin', 'oxytocin and placebo', 'placebo']","['Salivary oxytocin', 'peripheral oxytocin concentrations']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",100.0,0.442201,Trauma did not moderate this effect.,"[{'ForeName': 'Iro', 'Initials': 'I', 'LastName': 'Fragkaki', 'Affiliation': 'Radboud University, Behavioural Science Institute, Montessorilaan 3, 6525 HR, Nijmegen, the Netherlands. Electronic address: i.fragkaki@pwo.ru.nl.'}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Glennon', 'Affiliation': 'Radboud University Medical Center, Donders Institute for Brain, Cognition and Behaviour, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, the Netherlands.'}, {'ForeName': 'Maaike', 'Initials': 'M', 'LastName': 'Cima', 'Affiliation': 'Radboud University, Behavioural Science Institute, Montessorilaan 3, 6525 HR, Nijmegen, the Netherlands.'}]",Biological psychology,['10.1016/j.biopsycho.2020.107903']
3083,32442688,"A commentary on ""Efficacy of single layered intestinal anastomosis over double layered intestinal anastomosis - An open labeled, randomized controlled trial"" - What is missing for a careful analysis? The importance of considering all the factors involved.",,2020,,[],['single layered intestinal anastomosis'],[],[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}]",[],,0.102212,,"[{'ForeName': 'Leandro Ryuchi', 'Initials': 'LR', 'LastName': 'Iuamoto', 'Affiliation': 'Department of Surgery, Laboratory of Medical Research 02, Division of Human Structural Topography, University of Sao Paulo School of Medicine, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Meyer', 'Affiliation': 'General and Gastrointestinal (GI) Surgeon, Hospital Das Clínicas, Department of Gastroenterology, University of Sao Paulo School of Medicine, Sao Paulo, SP, Brazil. Electronic address: alberto.meyer@usp.br.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.05.045']
3084,32443329,A study for precision diagnosing and treatment strategies in difficult-to-treat AIDS cases and HIV-infected patients with highly fatal or highly disabling opportunistic infections.,"BACKGROUND


An increased frequency of toxoplasma encephalitis, caused by Toxoplasma gondii, has been reported in AIDS patients, especially in those with CD4+ T cell counts <100 cells/μL. Several guidelines recommend the combination of pyrimethamine, sulfadiazine, and leucovorin as the preferred regimen for AIDS-associated toxoplasma encephalitis. However, it is not commonly used in China due to limited access to pyrimethamine and sulfadiazine. The synergistic sulfonamides tablet formulation is a combination of trimethoprim (TMP), sulfadiazine and sulfamethoxazole (SMX), and is readily available in China. Considering its constituent components, we hypothesize that this drug may be used as a substitute for sulfadiazine and TMP-SMX. We have therefore designed the present trial, and propose to investigate the efficacy and safety of synergistic sulfonamides combined with clindamycin for the treatment of toxoplasma encephalitis.
METHODS/DESIGN


This study will be an open-labeled, multi-center, prospective, randomized, and controlled trial. A total of 200 patients will be randomized into TMP-SMX plus azithromycin group, and synergistic sulfonamides plus clindamycin group at a ratio of 1:1. All participants will be invited to participate in a 48-week follow-up schedule once enrolled. The primary outcomes will be clinical response rate and all-cause mortality at 12 weeks. The secondary outcomes will be clinical response rate and all-cause mortality at 48 weeks, and adverse events at each visit during the follow-up period.
DISCUSSION


We hope that the results of this study will be able to provide reliable evidence for the efficacy and safety of synergistic sulfonamides for its use in AIDS patients with toxoplasma encephalitis.
TRIAL REGISTRATION


This study was registered as one of 12 clinical trials under the name of a general project at chictr.gov on February 1, 2019, and the registration number of the general project is ChiCTR1900021195. This study is still recruiting now, and the first patient was screened on March 22, 2019.",2020,"The secondary outcomes will be clinical response rate and all-cause mortality at 48 weeks, and adverse events at each visit during the follow-up period.
","['12 clinical trials under the name of a general project at chictr.gov on February 1, 2019, and the registration number of the general project is ChiCTR1900021195', 'difficult-to-treat AIDS cases and HIV-infected patients with highly fatal or highly disabling opportunistic infections', '200 patients', 'AIDS patients with toxoplasma encephalitis']","['clindamycin', 'synergistic sulfonamides plus clindamycin', 'pyrimethamine', 'TMP-SMX plus azithromycin', 'trimethoprim (TMP), sulfadiazine and sulfamethoxazole (SMX', 'pyrimethamine, sulfadiazine, and leucovorin']","['clinical response rate and all-cause mortality', 'clinical response rate and all-cause mortality at 48 weeks, and adverse events']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0029118', 'cui_str': 'Opportunistic infectious disease'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0085315', 'cui_str': 'Meningoencephalitis due to acquired toxoplasmosis'}]","[{'cui': 'C0008947', 'cui_str': 'Clindamycin'}, {'cui': 'C0038760', 'cui_str': 'Sulfonamide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0034283', 'cui_str': 'Pyrimethamine'}, {'cui': 'C0041044', 'cui_str': 'sulfamethoxazole and trimethoprim'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0041041', 'cui_str': 'Trimethoprim'}, {'cui': 'C0038675', 'cui_str': 'Sulfadiazine'}, {'cui': 'C0038689', 'cui_str': 'Sulfamethoxazole'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",200.0,0.11167,"The secondary outcomes will be clinical response rate and all-cause mortality at 48 weeks, and adverse events at each visit during the follow-up period.
","[{'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing, China.'}, {'ForeName': 'Yan-Ming', 'Initials': 'YM', 'LastName': 'Zeng', 'Affiliation': ''}, {'ForeName': 'Yan-Qiu', 'Initials': 'YQ', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'Yuan-Yuan', 'Initials': 'YY', 'LastName': 'Qin', 'Affiliation': ''}, {'ForeName': 'Yao-Kai', 'Initials': 'YK', 'LastName': 'Chen', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020146']
3085,32443332,"Research ""recover from illness defense complex"" helper T cell immune mechanisms based on the ""Fuxie"" theory clearing away heat evil thoroughly nourishing kidney treatment of recurrent blood-heat syndrome Psoriasis.","INTRODUCTION


Psoriasis vulgaris (PV) is a chronic, painful, disfiguring, and disabling dermatological disease, which affects the physical and mental health of patients and impacts their quality of life. Current conventional systemic therapies can be costly, present risks of side effects, have limited efficacy and commonly recur following treatment cessation. Some Chinese herbal medicine therapies have shown therapeutic benefits for psoriasis vulgaris, including relieving symptoms and improving quality of life, and a potential of reducing relapse rate. However, explicit evidence has not yet been obtained.
METHODS AND ANALYSIS


This is a pilot randomized controlled trial with the objective of investigating the effect of Jia Wei Liang Xue Xiao Feng San granules on relapse rate of recurrent PV and the correlation between Psoriasis area severity index (PASI) and key psoriasis-related cytokine changes and the number of cells. A total of 102 participants were recruited for this study, including 72 patients with recurrent PV, 15 healthy volunteers and 15 patients with psoriasis vulgaris who have recovered for more than 1 year. A total of 72 patients, with recurrent PV, will be randomized (1:1) to receive the oral Chinese herbal medicine Jia Wei Liang Xue Xiao Feng San or the oral Acitretin Capsule treatments for a period of 8 weeks. After this period, participants whose PASI scores improvement reached more than 75%, will undergo a 52-week follow-up phase.The primary outcome measures are as follows:The secondary study outcomes will include:This trial may provide a novel regimen for recurrent PV patients if the granules decrease recurrence rate without further adverse effects.
ETHICS AND DISSEMINATION


The ethics approval was provided by the Sichuan Traditional Chinese medicine regional ethics review committee. The ethics approval number is 2018KL-055. The design and the results of the study will be disseminated through peer-reviewed publications and conference presentations.
TRIAL REGISTRATION NUMBER


Chinese Clinical Trial Registry (ChiCTR1900022766).",2020,"Some Chinese herbal medicine therapies have shown therapeutic benefits for psoriasis vulgaris, including relieving symptoms and improving quality of life, and a potential of reducing relapse rate.","['102 participants were recruited for this study, including 72 patients with recurrent PV, 15 healthy volunteers and 15 patients with psoriasis vulgaris who have recovered for more than 1 year', '72 patients, with recurrent PV']","['oral Chinese herbal medicine Jia Wei Liang Xue', 'Jia Wei Liang Xue Xiao Feng San granules']","['recurrence rate without further adverse effects', 'relapse rate of recurrent PV', 'PASI scores improvement']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0263361', 'cui_str': 'Psoriasis vulgaris'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1273412', 'cui_str': 'Chinese herbal medicine'}, {'cui': 'C3495559', 'cui_str': 'Juvenile chronic arthritis'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0263361', 'cui_str': 'Psoriasis vulgaris'}, {'cui': 'C4324362', 'cui_str': 'Psoriasis area severity index'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",102.0,0.233689,"Some Chinese herbal medicine therapies have shown therapeutic benefits for psoriasis vulgaris, including relieving symptoms and improving quality of life, and a potential of reducing relapse rate.","[{'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Hospital of Chengdu University of traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Ping-Sheng', 'Initials': 'PS', 'LastName': 'Hao', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020161']
3086,32443343,Impact of twice- or three-times-weekly maintenance hemodialysis on patient outcomes: A multicenter randomized trial.,"AIM


Maintenance hemodialysis (MHD) frequency is associated with survival and complication rates. Achieving the optimal balance between healthcare, quality of life (QOL), and medical costs is challenging. We compared complications, inflammatory status, nutritional status, and QOL between patients with different MHD frequencies.
MATERIAL AND METHODS


This was a multicenter randomized trial of patients treated between May 2011 and August 2017 at 3 tertiary hospitals in Wenzhou. Patients were grouped according to their treatment schedule over 1 year: twice-weekly or 3-times-weekly. Complications, biochemistry parameters, and QOL (KDQOL-SFTM 1.3 scale) were assessed.
RESULTS


One hundred forty patients were included aged 29 to 68 years (mean age, 50.9 ± 4.3 years). There were no significant differences in infection, heart failure, or cerebral hemorrhage complications between the 2 groups (P = .664). Pre-dialysis hemoglobin, high-sensitivity C-reactive protein, serum albumin, total cholesterol, triglyceride, calcium, phosphate, parathyroid hormone, and ejection fraction were similar in both groups (P > .05). After 1 year of MHD, both groups exhibited significant improvements in these parameters (all P < .05) with no significant differences between groups. Serum creatinine, blood urea nitrogen (BUN), and weekly standard hemodialysis treatment adequacy did not improve after treatment (all P > .05), although a difference in BUN was observed between the 2 groups (P < .001). QOL was superior in the twice-weekly group than in the 3-times-weekly group (all P < .05), except for social support, which was slightly better in the 3-times-weekly group than in the twice-weekly group.
CONCLUSIONS


Twice- and 3-times-weekly MHD resulted in comparable inflammatory and nutritional clinical outcomes and adverse events. QOL was better for the twice-weekly schedule. Even for patients with economic constraints, twice- or 3-times-weekly MHD should be selected with caution after consideration of BUN levels at baseline.",2020,"serum albumin, total cholesterol, triglyceride, calcium, phosphate, parathyroid hormone, and ejection fraction were similar in both groups (P > .05).","['patients treated between May 2011 and August 2017 at 3 tertiary hospitals in Wenzhou', 'One hundred forty patients were included aged 29 to 68 years (mean age, 50.9\u200a±\u200a4.3 years', 'patient outcomes']",['twice- or three-times-weekly maintenance hemodialysis'],"['Serum creatinine, blood urea nitrogen (BUN), and weekly standard hemodialysis treatment adequacy', 'serum albumin, total cholesterol, triglyceride, calcium, phosphate, parathyroid hormone, and ejection fraction', 'QOL', 'BUN', 'inflammatory and nutritional clinical outcomes and adverse events', 'infection, heart failure, or cerebral hemorrhage complications', 'survival and complication rates', 'healthcare, quality of life (QOL), and medical costs', 'Complications, biochemistry parameters, and QOL (KDQOL-SFTM 1.3 scale', 'complications, inflammatory status, nutritional status, and QOL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517759', 'cui_str': '4.3'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}]","[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}]",140.0,0.0354086,"serum albumin, total cholesterol, triglyceride, calcium, phosphate, parathyroid hormone, and ejection fraction were similar in both groups (P > .05).","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Dai', 'Affiliation': ""Department of Nephrology, Ruian People's Hospital, Ruian City, Wenzhou, Zhejiang, China.""}, {'ForeName': 'Chan', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'Jinnv', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Huanlin', 'Initials': 'H', 'LastName': 'Jin', 'Affiliation': ''}, {'ForeName': 'Fadong', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Zengqi', 'Initials': 'Z', 'LastName': 'Xue', 'Affiliation': ''}, {'ForeName': 'Chusheng', 'Initials': 'C', 'LastName': 'Miao', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020202']
3087,32443348,Adductor canal block with periarticular infiltration versus periarticular infiltration alone after total knee arthroplasty: A randomized controlled trial protocol.,"BACKGROUND


Effective postoperative analgesia may enhance early rehabilitation after total knee arthroplasty (TKA). The purpose of this study is to perform a randomized controlled trial to compare the efficiency of adductor canal block (ACB) with periarticular infiltration (PAI) versus PAI alone for early postoperative pain treatment after TKA.
METHODS


After institutional review board approval, written informed consent was obtained from patients undergoing elective TKA. Subjects were randomized into 2 groups as follows: adductor canal blockade with 30 mL of 0.5% ropivacaine and 100 mcg of clonidine. All patients received a periarticular infiltration mixture intraoperatively with scheduled and patient requested oral and IV analgesics postoperatively for breakthrough pain. The primary outcome was morphine consumption in the first 24 hours. Secondary outcomes included pain scores, morphine consumption at 48 hours, opioid-related side effects (post-operative nausea/vomiting, sedation scores), functional outcomes, quadriceps strength, and length of hospital stay.
CONCLUSIONS


For the present trial, we hypothesized that patients receiving adductor canal block + PAI would have significantly lower morphine consumption and pain scores after surgery.
TRIAL REGISTRATION NUMBER


researchregistry5490.",2020,"For the present trial, we hypothesized that patients receiving adductor canal block + PAI would have significantly lower morphine consumption and pain scores after surgery.
","['total knee arthroplasty (TKA', 'after total knee arthroplasty', 'patients undergoing elective TKA', 'early postoperative pain treatment after TKA']","['clonidine', 'periarticular infiltration mixture intraoperatively with scheduled and patient requested oral and IV analgesics', 'Adductor canal block with periarticular infiltration versus periarticular infiltration alone', 'adductor canal block (ACB) with periarticular infiltration (PAI) versus PAI alone', 'adductor canal blockade with 30\u200amL of 0.5% ropivacaine']","['morphine consumption', 'pain scores, morphine consumption at 48\u200ahours, opioid-related side effects (post-operative nausea/vomiting, sedation scores), functional outcomes, quadriceps strength, and length of hospital stay', 'morphine consumption and pain scores']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}]","[{'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0595695', 'cui_str': 'Periarticular route'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0332153', 'cui_str': 'Requested by patient'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.331919,"For the present trial, we hypothesized that patients receiving adductor canal block + PAI would have significantly lower morphine consumption and pain scores after surgery.
","[{'ForeName': 'Yongcheng', 'Initials': 'Y', 'LastName': 'Ren', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Jiacai', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Jianming', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Ophthalmology and Otorhinolaryngology, Qianjiang District Chinese medicine hospital of Chongqing, Chongqing, China.'}]",Medicine,['10.1097/MD.0000000000020213']
3088,32443695,The Effects of  Aronia melanocarpa  Juice Consumption on the mRNA Expression Profile in Peripheral Blood Mononuclear Cells in Subjects at Cardiovascular Risk.,"Foods and food products that contain polyphenols are proposed to modulate risk of cardiovascular disease. The aim of this three-arm, crossover, randomized, double-blind, placebo-controlled intervention study was to examine the impact of  Aronia melanocarpa  juice (AMJ), high-polyphenol (AMJ treatment, 1.17 g/100 mL polyphenols) and low-polyphenol (dAMJ treatment, 0.29 g/100 mL polyphenols) dose, on the transcriptome in peripheral blood mononuclear cells (PBMC) of 19 subjects at cardiovascular risk. Transcriptome data were obtained by microarray. Bioinformatic functional annotation analysis was performed on both the whole transcriptome datasets and the differentially expressed genes (DEGs). Expression of selected DEGs was validated by RT-qPCR. Administration of AMJ and dAMJ treatments during the two consecutive four-week treatment periods had additive effects on PBMC transcriptome profiles, with the most pronounced and specific effect noticed for AMJ in the last treatment period (TP3) of the trial. Between the high-dose and low-dose treatments in TP3, there was a multitude of overlapping DEGs and DEG-enriched biological processes and pathways, which primarily included immunomodulation and regulation of cell proliferation/death. Increased expression of  TNF ,  IL1B ,  IL8 ,  RGS1 ,  OSM , and  DUSP2  in TP3 was confirmed by RT-qPCR. The results suggest the immunomodulatory effects of prolonged habitual consumption of polyphenol-rich aronia juice in individuals at cardiovascular risk.",2020,"Increased expression of  TNF ,  IL1B ,  IL8 ,  RGS1 ,  OSM , and  DUSP2  in TP3 was confirmed by RT-qPCR.","['individuals at cardiovascular risk', '19 subjects at cardiovascular risk', 'Subjects at Cardiovascular Risk']","['Aronia melanocarpa  juice (AMJ), high-polyphenol (AMJ treatment, 1.17 g/100 mL polyphenols) and low-polyphenol (dAMJ treatment, 0.29 g/100 mL polyphenols', 'AMJ and dAMJ', 'polyphenol-rich aronia juice', 'Aronia melanocarpa  Juice Consumption', 'placebo']","['peripheral blood mononuclear cells (PBMC', 'Increased expression of  TNF ,  IL1B ,  IL8 ,  RGS1 ,  OSM , and  DUSP2  in TP3', 'Peripheral Blood Mononuclear Cells']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C1449661', 'cui_str': 'Aronia melanocarpa'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517494', 'cui_str': '1.17'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4517446', 'cui_str': '0.29'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C1215581', 'cui_str': 'Aronia'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C1448758', 'cui_str': 'RGS1 protein, human'}, {'cui': 'C0439186', 'cui_str': 'osmol'}, {'cui': 'C0075032', 'cui_str': 'splenotritin'}]",19.0,0.0972833,"Increased expression of  TNF ,  IL1B ,  IL8 ,  RGS1 ,  OSM , and  DUSP2  in TP3 was confirmed by RT-qPCR.","[{'ForeName': 'Ljiljana', 'Initials': 'L', 'LastName': 'Stojković', 'Affiliation': 'Laboratory for Radiobiology and Molecular Genetics, ""Vinča"" Institute of Nuclear Sciences, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Jovanović', 'Affiliation': 'Laboratory for Radiobiology and Molecular Genetics, ""Vinča"" Institute of Nuclear Sciences, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Zivković', 'Affiliation': 'Laboratory for Radiobiology and Molecular Genetics, ""Vinča"" Institute of Nuclear Sciences, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Manja', 'Initials': 'M', 'LastName': 'Zec', 'Affiliation': 'Centre of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Djurić', 'Affiliation': 'Laboratory for Radiobiology and Molecular Genetics, ""Vinča"" Institute of Nuclear Sciences, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Zivotić', 'Affiliation': 'Laboratory for Radiobiology and Molecular Genetics, ""Vinča"" Institute of Nuclear Sciences, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Jovana', 'Initials': 'J', 'LastName': 'Kuveljić', 'Affiliation': 'Laboratory for Radiobiology and Molecular Genetics, ""Vinča"" Institute of Nuclear Sciences, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Kolaković', 'Affiliation': 'Laboratory for Radiobiology and Molecular Genetics, ""Vinča"" Institute of Nuclear Sciences, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Kolić', 'Affiliation': 'Laboratory for Radiobiology and Molecular Genetics, ""Vinča"" Institute of Nuclear Sciences, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Djordjević', 'Affiliation': 'Laboratory for Radiobiology and Molecular Genetics, ""Vinča"" Institute of Nuclear Sciences, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Glibetić', 'Affiliation': 'Centre of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Dragan', 'Initials': 'D', 'LastName': 'Alavantić', 'Affiliation': 'Laboratory for Radiobiology and Molecular Genetics, ""Vinča"" Institute of Nuclear Sciences, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Stanković', 'Affiliation': 'Laboratory for Radiobiology and Molecular Genetics, ""Vinča"" Institute of Nuclear Sciences, University of Belgrade, 11000 Belgrade, Serbia.'}]",Nutrients,['10.3390/nu12051484']
3089,32443744,Effectiveness of A Pilates Training Program on Cognitive and Functional Abilities in Postmenopausal Women.,"The purpose of this study was to determine the effects of a Pilates exercises program on the cognitive and physical functioning of older Spanish women. This study is a randomized clinical trial; a total of 110 women aged ≥60 years were initially allocated to either a Pilates group (PG, n = 55), who underwent a 12-week Pilates exercise program, or to a control group (CG, n = 55), who did not receive any intervention. Global cognitive function (Mini-Mental State Examination), verbal fluency (Isaacs test), executive function (Trail Making Test), functional flexibility (Back Scratch Test and Chair Sit-and-Reach Test), and lower-body strength (30 s Chair-Stand Test) were assessed before and immediately after the intervention period. The main findings of this study suggest that women in the PG (within-group differences) experienced improvements across all the variables examined except for global cognitive function. When compared with the CG (between-group differences), our analysis revealed significant benefits in the PG for all measures except for global cognitive function and functional flexibility (Back Scratch Test). In conclusion, our results suggest that Pilates has the potential to improve both cognitive and functional abilities among Spanish women aged 60 years and over.",2020,"When compared with the CG (between-group differences), our analysis revealed significant benefits in the PG for all measures except for global cognitive function and functional flexibility (Back Scratch Test).","['Spanish women aged 60 years and over', 'Postmenopausal Women', '110 women aged ≥60 years', 'older Spanish women']","['Pilates Training Program', 'Pilates exercises program', 'Pilates exercise program, or to a control group (CG, n = 55), who did not receive any intervention']","['cognitive and functional abilities', 'global cognitive function and functional flexibility (Back Scratch Test', 'global cognitive function', 'Global cognitive function (Mini-Mental State Examination), verbal fluency (Isaacs test), executive function (Trail Making Test), functional flexibility (Back Scratch Test and Chair Sit-and-Reach Test), and lower-body strength (30 s Chair-Stand Test', 'Cognitive and Functional Abilities', 'cognitive and physical functioning']","[{'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1321049', 'cui_str': 'Pilates exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0430562', 'cui_str': 'Scratch test'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",110.0,0.0263371,"When compared with the CG (between-group differences), our analysis revealed significant benefits in the PG for all measures except for global cognitive function and functional flexibility (Back Scratch Test).","[{'ForeName': 'Patricia Alexandra', 'Initials': 'PA', 'LastName': 'García-Garro', 'Affiliation': 'Department of Health Sciences, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}, {'ForeName': 'Fidel', 'Initials': 'F', 'LastName': 'Hita-Contreras', 'Affiliation': 'Department of Health Sciences, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Martínez-Amat', 'Affiliation': 'Department of Health Sciences, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Achalandabaso-Ochoa', 'Affiliation': 'Department of Health Sciences, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}, {'ForeName': 'José Daniel', 'Initials': 'JD', 'LastName': 'Jiménez-García', 'Affiliation': 'Department of Teaching Physical Education, Fine Arts and Music, University of Cádiz, 11003 Cádiz, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cruz-Díaz', 'Affiliation': 'Department of Health Sciences, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}, {'ForeName': 'Agustín', 'Initials': 'A', 'LastName': 'Aibar-Almazán', 'Affiliation': 'Department of Health Sciences, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17103580']
3090,32443843,Effect of Exclusive Primer and Adhesive on Microtensile Bond Strength of Self-Adhesive Resin Cement to Dentin.,"The aim of this study was to investigate the effect of G-CEM One Primer (GCOP) and self-etching adhesive on the microtensile bond strength (µTBS) between self-adhesive resin cement G-CEM One (GCO) and dentin. Teeth were sectioned to expose the flat dentin surface and randomly assigned into five groups (n = 15) according to the dentin surface treatment: 1) no surface treatment, 2) GCOP, 3) All-Bond Universal (ABU), 4) GCOP followed by ABU (GCOP/ABU), 5) ABU followed by GCOP (ABU/GCOP). The composite resin blocks were bonded to the dentin surface using GCO. The specimens were stored in distilled water at 37 °C for 24 h, then sectioned into sticks (1 mm × 10 mm). The μTBS values were statistically analyzed using 1-way analysis of variance (ANOVA) and Tukey's honestly significant difference (HSD) test ( α  = 0.05) and failure mode was examined under a stereomicroscope. The bonding interface of each specimen was evaluated using confocal laser scanning microscopy. The GCOP group exhibited the highest µTBS value and there were no significant differences observed between GCOP, GCOP/ABU, ABU/GCOP groups ( p  > 0.05). The use of GCOP with GCO results in the improved µTBS between GCO and dentin. In conclusion, using only GCOP with GCO for bonding of indirect restoration is extremely simple and increasing bond strength.",2020,"The GCOP group exhibited the highest µTBS value and there were no significant differences observed between GCOP, GCOP/ABU, ABU/GCOP groups ( p  > 0.05).",['Self-Adhesive Resin Cement to Dentin'],"['dentin surface treatment: 1) no surface treatment, 2) GCOP, 3) All-Bond Universal (ABU), 4) GCOP followed by ABU (GCOP/ABU), 5) ABU followed by GCOP (ABU/GCOP', 'GCOP', 'G-CEM']","['μTBS values', 'highest µTBS value', 'microtensile bond strength (µTBS']","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0376523', 'cui_str': 'Resin Cement'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}]","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0045845', 'cui_str': '2-amino-4-phosphonobutyric acid'}, {'cui': 'C0378574', 'cui_str': '2-chloroethyl methyl sulfide'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}]",,0.0204166,"The GCOP group exhibited the highest µTBS value and there were no significant differences observed between GCOP, GCOP/ABU, ABU/GCOP groups ( p  > 0.05).","[{'ForeName': 'Bit-Na', 'Initials': 'BN', 'LastName': 'Kim', 'Affiliation': 'Department of Conservative Dentistry, School of Dentistry, Pusan National University, Dental Research Institute, Yangsan 50612, Korea.'}, {'ForeName': 'Sung-Ae', 'Initials': 'SA', 'LastName': 'Son', 'Affiliation': 'Department of Conservative Dentistry, School of Dentistry, Pusan National University, Dental Research Institute, Yangsan 50612, Korea.'}, {'ForeName': 'Jeong-Kil', 'Initials': 'JK', 'LastName': 'Park', 'Affiliation': 'Department of Conservative Dentistry, School of Dentistry, Pusan National University, Dental Research Institute, Yangsan 50612, Korea.'}]","Materials (Basel, Switzerland)",['10.3390/ma13102353']
3091,32445396,Author response to: Comment on: Comparison of the duration of hospital stay after laparoscopic or open distal pancreatectomy: randomized controlled trial.,,2020,,[],['laparoscopic or open distal pancreatectomy'],['hospital stay'],[],"[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0176940', 'cui_str': 'Distal subtotal pancreatectomy'}]","[{'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",,0.0911117,,"[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Björnsson', 'Affiliation': 'Department of Surgery and Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lindhoff Larsson', 'Affiliation': 'Department of Surgery and Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hjalmarsson', 'Affiliation': 'Department of Surgery, Blekinge Hospital, Karlskrona, Sweden.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Gasslander', 'Affiliation': 'Department of Surgery and Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Sandström', 'Affiliation': 'Department of Surgery and Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}]",The British journal of surgery,['10.1002/bjs.11681']
3092,32445690,"Minocycline and celecoxib as adjunctive treatments for bipolar depression: a multicentre, factorial design randomised controlled trial.","BACKGROUND


Several small studies suggest that the adjunctive use of anti-inflammatory agents might improve depressive symptoms in bipolar disorder. However, there are few well designed, appropriately powered clinical trials assessing the efficacy of these novel treatment strategies. We aimed to assess the efficacy of adjunctive minocycline or celecoxib in this setting.
METHODS


This double-blind, 12-week, randomised, placebo-controlled trial was done in four outpatient psychiatric clinics in Pakistan. Eligible participants were adults (aged 18-65 years) with DSM-5 bipolar disorder (type I or II) and a major depressive episode. In a 2 × 2 factorial design, participants were randomly assigned (1:1:1:1) to receive either active minocycline plus active celecoxib, active minocycline plus placebo celecoxib, placebo minocycline plus active celecoxib, or placebo minocycline plus placebo celecoxib. The primary outcome was the mean change from baseline to week 12 in score on the 17-item Hamilton Depression Rating Scale (HAMD-17), assessed in all randomised participants (missing data were imputed and assumed to be missing at random). The trial was registered with ClinicalTrials.gov, NCT02703363.
FINDINGS


266 (17%) of 1542 patients assessed between May 1, 2016, and March 31, 2019, were randomly assigned to receive minocycline plus celecoxib (n=68), minocycline plus placebo (n=66), celecoxib plus placebo (n=66), or placebo plus placebo (n=66). From baseline to week 12, depressive symptoms as per HAMD-17 reduced in all four groups (from 24·5-25·2 to 11·3-12·8), but these reductions did not differ significantly between the groups. In terms of main effects, reductions in HAMD-17 did not differ for patients treated with minocycline (mean adjusted difference vs non-minocycline 1·48 [95% CI -0·41 to 3·36]; p=0·123) or for celecoxib (mean adjusted difference vs non-celecoxib -0·74 [-2·61 to 1·14]; p=0·443). Rates of serious adverse effects did not differ between groups (31 participants had a manic switch, two self-harmed, and one died in a motor vehicle accident).
INTERPRETATION


We found no evidence that minocycline or celecoxib was superior to placebo for the treatment of bipolar depression. This large trial casts doubt on the potential therapeutic benefits of adjunctive anti-inflammatory drugs for the acute management of bipolar depression.
FUNDING


Stanley Medical Research Institute.",2020,"Rates of serious adverse effects did not differ between groups (31 participants had a manic switch, two self-harmed, and one died in a motor vehicle accident).
","['266 (17%) of 1542 patients assessed between May 1, 2016, and March 31, 2019', 'four outpatient psychiatric clinics in Pakistan', 'bipolar depression', 'Eligible participants were adults (aged 18-65 years) with DSM-5 bipolar disorder (type I or II) and a major depressive episode']","['Minocycline and celecoxib', 'active minocycline plus active celecoxib, active minocycline plus placebo celecoxib, placebo minocycline plus active celecoxib, or placebo minocycline plus placebo celecoxib', 'adjunctive minocycline or celecoxib', 'minocycline plus placebo', 'celecoxib plus placebo', 'minocycline', 'placebo plus placebo', 'celecoxib', 'minocycline plus celecoxib', 'placebo']","['HAMD-17', 'depressive symptoms as per HAMD-17', 'mean change from baseline to week 12 in score on the 17-item Hamilton Depression Rating Scale (HAMD-17', 'Rates of serious adverse effects', 'depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}]","[{'cui': 'C0026187', 'cui_str': 'Minocycline'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.814161,"Rates of serious adverse effects did not differ between groups (31 participants had a manic switch, two self-harmed, and one died in a motor vehicle accident).
","[{'ForeName': 'Muhammad Ishrat', 'Initials': 'MI', 'LastName': 'Husain', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada. Electronic address: ishrat.husain@camh.ca.'}, {'ForeName': 'Imran B', 'Initials': 'IB', 'LastName': 'Chaudhry', 'Affiliation': 'Division of Neuroscience and Experimental Psychology, School of Biological Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK; Pakistan Institute of Learning and Living, Karachi, Pakistan; Department of Pyschiatry, Dow University of Health Sciences, Karachi, Pakistan; Ziauddin University Hospital, Karachi, Pakistan.'}, {'ForeName': 'Ameer B', 'Initials': 'AB', 'LastName': 'Khoso', 'Affiliation': 'Pakistan Institute of Learning and Living, Karachi, Pakistan.'}, {'ForeName': 'Muhammad Omair', 'Initials': 'MO', 'LastName': 'Husain', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hodsoll', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK; Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Moin A', 'Initials': 'MA', 'LastName': 'Ansari', 'Affiliation': 'Department of Psychiatry, Liaquat University of Medical and Health Sciences, Hyderabad, Pakistan.'}, {'ForeName': 'Haider A', 'Initials': 'HA', 'LastName': 'Naqvi', 'Affiliation': 'Department of Pyschiatry, Dow University of Health Sciences, Karachi, Pakistan.'}, {'ForeName': 'Fareed A', 'Initials': 'FA', 'LastName': 'Minhas', 'Affiliation': 'Institute of Psychiatry, Rawalpindi Medical College, Rawalpindi, Pakistan.'}, {'ForeName': 'Andre F', 'Initials': 'AF', 'LastName': 'Carvalho', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Meyer', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Deakin', 'Affiliation': 'Division of Neuroscience and Experimental Psychology, School of Biological Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Nusrat', 'Initials': 'N', 'LastName': 'Husain', 'Affiliation': 'Division of Psychology and Mental Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Allan H', 'Initials': 'AH', 'LastName': 'Young', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]",The lancet. Psychiatry,['10.1016/S2215-0366(20)30138-3']
3093,32445736,"A telehealth lifestyle intervention to reduce excess gestational weight gain in pregnant women with overweight or obesity (GLOW): a randomised, parallel-group, controlled trial.","BACKGROUND


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


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


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


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


US National Institutes of Health.",2020,"Compared with usual care, women in the lifestyle intervention had reduced weekly rate of GWG (mean 0·26 kg per week [SD 0·15] vs 0·32","[""Women at 8-15 weeks' gestation with singletons, pre-pregnancy BMI 25·0-40·0 kg/m 2 , and aged 18 years or older"", 'women with overweight and 5 kg for women with obesity', '199 women in the lifestyle intervention group (one lost to follow-up) and 195 in the usual care group (three lost to follow-up', 'five antenatal clinics of Kaiser Permanente; Oakland, San Leandro, Walnut Creek, Fremont, and Santa Clara, CA, USA', 'women with overweight or obesity', 'women in the lifestyle intervention group and 134 (69%) women in the usual care group exceeded Institute of Medicine guidelines for rate of GWG per week (relative risk 0·70, 95% CI 0·59 to 0·83', 'women with overweight or obesity by using telehealth lifestyle interventions', 'pregnant women with overweight or obesity (GLOW', 'Between March 24, 2014, and Sept 26, 2017, 5329 women were assessed for eligibility and 200 were randomly assigned to the lifestyle intervention group and 198 to the usual care group']","['telehealth lifestyle intervention or usual antenatal care', 'telephone sessions on behavioural strategies to improve weight, diet, and physical activity, and stress management to help women meet a trial goal of gaining at the lower limit of the Institute of Medicine (IOM) guidelines range for total GWG', ""Usual antenatal care included an antenatal visit at 7-10 weeks' gestation, an additional seven antenatal visits, on average, and periodic health education newsletters, including the IOM GWG guidelines and information"", 'primarily telehealth lifestyle intervention', 'telehealth lifestyle intervention']","['perinatal complications', 'weekly rate of GWG', 'weekly rate of GWG expressed as excess GWG, per Institute of Medicine guidelines and mean assessed in the intention-to-treat population', 'gestational weight gain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0330971', 'cui_str': 'Juglans'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0021621', 'cui_str': 'Institute of Medicine (U.S.)'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C4748924', 'cui_str': 'Global developmental delay, lung cysts, overgrowth, Wilms tumor syndrome'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0021621', 'cui_str': 'Institute of Medicine (U.S.)'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332182', 'cui_str': 'Periodic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027988', 'cui_str': 'Newsletters'}]","[{'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0021621', 'cui_str': 'Institute of Medicine (U.S.)'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",5329.0,0.152039,"Compared with usual care, women in the lifestyle intervention had reduced weekly rate of GWG (mean 0·26 kg per week [SD 0·15] vs 0·32","[{'ForeName': 'Assiamira', 'Initials': 'A', 'LastName': 'Ferrara', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA. Electronic address: assiamira.ferrara@kp.org.'}, {'ForeName': 'Monique M', 'Initials': 'MM', 'LastName': 'Hedderson', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}, {'ForeName': 'Susan D', 'Initials': 'SD', 'LastName': 'Brown', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA; Department of Internal Medicine, School of Medicine, University of California, Davis, Sacramento, CA, USA.'}, {'ForeName': 'Samantha F', 'Initials': 'SF', 'LastName': 'Ehrlich', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA; Department of Public Health, University of Tennessee Knoxville, Knoxville, TN, USA.'}, {'ForeName': 'Ai-Lin', 'Initials': 'AL', 'LastName': 'Tsai', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}, {'ForeName': 'Juanran', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}, {'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Galarce', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}, {'ForeName': 'Santica', 'Initials': 'S', 'LastName': 'Marcovina', 'Affiliation': 'Northwest Lipid Metabolism and Diabetes Research Laboratories, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Catalano', 'Affiliation': 'Mother Infant Research Institute, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Charles P', 'Initials': 'CP', 'LastName': 'Quesenberry', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30107-8']
3094,32456230,The Effects of Tocotrienol-Rich Vitamin E (Tocovid) on Diabetic Neuropathy: A Phase II Randomized Controlled Trial.,"Chronic hyperglycemia increases oxidative stress, activates inflammatory pathways and reduces nerve growth factor (NGF) among diabetic patients, which contribute to development of diabetic peripheral neuropathy (DPN). Tocotrienol-Rich Vitamin E (Tocovid) possesses potent antioxidant and anti-inflammatory properties which are postulated to target these pathogeneses in order to ameliorate DPN. This study aims to evaluate the effects of Tocovid on nerve conduction parameters and serum biomarkers among diabetic patients. This multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial was conducted on 80 eligible participants. The intervention group ( n  = 39) was randomly allocated to receive 200 mg of Tocovid twice a day, and the control group ( n  = 41) received placebo twice a day. At the end of eight weeks, the nerve conduction parameters, as assessed by nerve conduction study, as well as serum biomarkers (NGF, malondialdehyde, vascular cell adhesion molecule 1, tumor necrosis factor receptor 1 and thromboxane B2) were compared between the two groups. Compared to placebo, Tocovid significantly improves the nerve conduction velocities of all nerves (+1.25 m/s, interquartile range [IQR] 3.35,  p  < 0.001, median nerve; +1.60 m/s, IQR 1.80,  p  < 0.001, sural nerve; +0.75 m/s, IQR 2.25,  p  < 0.001, tibial nerve). Meanwhile, the levels of serum NGF were significantly higher in the Tocovid group as compared to placebo at eight weeks post-intervention. Participants receiving Tocovid illustrated highly significant improvement in terms of nerve conduction velocities for all nerves tested after eight weeks of supplementation. In addition, Tocovid supplementation elevated the levels of serum NGF, in which its increase is postulated to reflect enhanced neuronal functions. This novel finding suggests that Tocovid could be a disease-modifying agent targeting serum NGF to improve nerve conduction velocities.",2020,Participants receiving Tocovid illustrated highly significant improvement in terms of nerve conduction velocities for all nerves tested after eight weeks of supplementation.,"['Diabetic Neuropathy', '80 eligible participants', 'diabetic patients']","['Tocovid supplementation', 'Tocotrienol-Rich Vitamin E (Tocovid', 'Tocovid', 'placebo']","['serum biomarkers (NGF, malondialdehyde, vascular cell adhesion molecule 1, tumor necrosis factor receptor 1 and thromboxane B2', 'nerve conduction velocities', 'nerve conduction parameters', 'levels of serum NGF']","[{'cui': 'C0011882', 'cui_str': 'Diabetic neuropathy'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4742400', 'cui_str': 'Tocovid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0949647', 'cui_str': 'Tocotrienols'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C1453722', 'cui_str': 'TNFRSF1A protein, human'}, {'cui': 'C0040059', 'cui_str': 'Thromboxane B>2<'}, {'cui': 'C0429381', 'cui_str': 'Nerve conduction velocity'}, {'cui': 'C0027788', 'cui_str': 'Nerve conduction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",80.0,0.207012,Participants receiving Tocovid illustrated highly significant improvement in terms of nerve conduction velocities for all nerves tested after eight weeks of supplementation.,"[{'ForeName': 'Yeek Tat', 'Initials': 'YT', 'LastName': 'Ng', 'Affiliation': 'Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, Subang Jaya 47500, Malaysia.'}, {'ForeName': 'Sonia Chew Wen', 'Initials': 'SCW', 'LastName': 'Phang', 'Affiliation': 'Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, Subang Jaya 47500, Malaysia.'}, {'ForeName': 'Gerald Chen Jie', 'Initials': 'GCJ', 'LastName': 'Tan', 'Affiliation': 'Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, Subang Jaya 47500, Malaysia.'}, {'ForeName': 'En Yng', 'Initials': 'EY', 'LastName': 'Ng', 'Affiliation': 'Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, Subang Jaya 47500, Malaysia.'}, {'ForeName': 'Nevein Philip', 'Initials': 'NP', 'LastName': 'Botross Henien', 'Affiliation': 'Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, Subang Jaya 47500, Malaysia.'}, {'ForeName': 'Uma Devi', 'Initials': 'UD', 'LastName': 'M Palanisamy', 'Affiliation': 'Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, Subang Jaya 47500, Malaysia.'}, {'ForeName': 'Badariah', 'Initials': 'B', 'LastName': 'Ahmad', 'Affiliation': 'Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, Subang Jaya 47500, Malaysia.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Abdul Kadir', 'Affiliation': 'Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, Subang Jaya 47500, Malaysia.'}]",Nutrients,['10.3390/nu12051522']
3095,32442828,Subgroup analysis of the early paracetamol trial to preterm infants found haemodynamic changes and improved oxygenation.,"BACKGROUND


We previously reported in a randomised trial that early intravenous paracetamol accelerated contraction of ductus arteriosus in very preterm infants (<32 gestation weeks).
AIMS


To monitor sequentially paracetamol effects on the blood pressure and brain tissue oxygenation in the infants participating the trial.
METHODS


In a double-blind trial, intravenous paracetamol or placebo was infused to 48 very premature infants starting within 24 h of birth for four days. Besides the ductus arteriosus, we systematically measured blood pressure, peripheral (spO 2 ) and regional cerebral oxygen saturation (rcSO 2 ), and cerebral fractional tissue oxygen extraction (cFTOE) during the study period.
RESULTS


Compared to the placebo, the paracetamol loading dose transiently decreased the arterial blood pressure. During treatment, the paracetamol-treated infants had higher spO 2  (p = .042) and rcSO 2  (p = .036) values than the placebo group infants. Additionally, the cFTOE values were lower in the paracetamol group during the study without statistical significance. All infants with closed ductus had higher tissue oxygenation and a lower cFTOE than infants with open ductus.
CONCLUSIONS


Paracetamol caused modest haemodynamic effects and increased cerebral oxygenation. They were mostly due to early contraction of ductus. Additional direct drug-effects in brain are not ruled-out.",2020,"During treatment, the paracetamol-treated infants had higher spO 2  (p = .042) and rcSO 2  (p = .036) values than the placebo group infants.","['very preterm infants (<32 gestation weeks', '48 very premature infants starting within 24\u202fh of birth for four days', 'infants participating the trial']","['paracetamol', 'intravenous paracetamol or placebo', 'Paracetamol', 'placebo']","['haemodynamic effects', 'haemodynamic changes and improved oxygenation', 'tissue oxygenation', 'arterial blood pressure', 'blood pressure and brain tissue oxygenation', 'blood pressure, peripheral (spO 2 ) and regional cerebral oxygen saturation (rcSO 2 ), and cerebral fractional tissue oxygen extraction (cFTOE', 'cerebral oxygenation']","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1272641', 'cui_str': 'Systemic arterial pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0440746', 'cui_str': 'Brain tissue'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C4273907', 'cui_str': 'Cerebral oxygen saturation'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]",48.0,0.459725,"During treatment, the paracetamol-treated infants had higher spO 2  (p = .042) and rcSO 2  (p = .036) values than the placebo group infants.","[{'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Härmä', 'Affiliation': 'PEDEGO Research Unit and Medical Research Center Oulu, University of Oulu, Oulu, Finland; Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Outi', 'Initials': 'O', 'LastName': 'Aikio', 'Affiliation': 'PEDEGO Research Unit and Medical Research Center Oulu, University of Oulu, Oulu, Finland; Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland. Electronic address: outi.aikio@ppshp.fi.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Härkin', 'Affiliation': 'PEDEGO Research Unit and Medical Research Center Oulu, University of Oulu, Oulu, Finland; Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Markku', 'Initials': 'M', 'LastName': 'Leskinen', 'Affiliation': 'PEDEGO Research Unit and Medical Research Center Oulu, University of Oulu, Oulu, Finland; Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Marita', 'Initials': 'M', 'LastName': 'Valkama', 'Affiliation': 'PEDEGO Research Unit and Medical Research Center Oulu, University of Oulu, Oulu, Finland; Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Saarela', 'Affiliation': 'PEDEGO Research Unit and Medical Research Center Oulu, University of Oulu, Oulu, Finland; Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Hallman', 'Affiliation': 'PEDEGO Research Unit and Medical Research Center Oulu, University of Oulu, Oulu, Finland; Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.'}]",Early human development,['10.1016/j.earlhumdev.2020.105042']
3096,32443302,Analgesia for spinal anesthesia positioning in elderly patients with proximal femoral fractures: Dexmedetomidine-ketamine versus dexmedetomidine-fentanyl.,"Elderly patients with femoral fractures are anticipated to endure the most pain caused by positional changes required for spinal anesthesia. To improve pain relief, we compared the analgesic effects of intravenous dexmedetomidine-ketamine and dexmedetomidine-fentanyl combinations to facilitate patient positioning for spinal anesthesia in elderly patients with proximal femoral fractures. Forty-six patients were randomly assigned to two groups and received either 1 mg/kg of intravenous ketamine (group K) or 1 μg/kg of intravenous fentanyl (group F) concomitant with a loading dose of dexmedetomidine 1 μg/kg over 10 minutes, then dexmedetomidine infusion only was continued at 0.6 μg/kg/h for following 20 minutes, and titrated at a rate of 0.2 to 0.6 μg/kg/h until the end of surgery. After completion of the infusion of either ketamine or fentanyl, the patients were placed in the lateral position with the fracture site up. The pain score (0 = calm, 1 = facial grimacing, 2 = moaning, 3 = screaming, and 4 = unable to proceed because of restlessness or agitation) was used to describe the pain intensity in each step during the procedure (lateral positioning, hip flexion, and lumbar puncture), and quality score (0 = poor hip flexion, 1 = satisfactory hip flexion, 2 = good hip flexion, and 3 = optimal hip flexion) was used to describe the quality of posture. Group K showed a median pain score of 0 (0-1), 0 (0-0) and 0 (0-0) in lateral positioning, hip flexion and lumbar puncture, respectively, while group F showed a score of 3 (2.75-3), 3 (2-3) and 0 (0-1), respectively. The pain score in lateral positioning (P < .0001) and hip flexion (P < .0001) was significantly lower in group K than group F. Group K showed the significantly higher quality scores of spinal anesthesia positioning (P = .0044) than group F. Hemodynamic adverse effects, such as bradycardia, hypotension, and desaturation, were not significantly different between the groups. The administration of dexmedetomidine-ketamine showed a greater advantage in reducing pain intensity and increasing the quality with patient positioning during spinal anesthesia in elderly patients with proximal femoral fractures, without any serious adverse effects.",2020,"The pain score in lateral positioning (P < .0001) and hip flexion (P < .0001) was significantly lower in group K than group F. Group K showed the significantly higher quality scores of spinal anesthesia positioning (P = .0044) than group F. Hemodynamic adverse effects, such as bradycardia, hypotension, and desaturation, were not significantly different between the groups.","['elderly patients with proximal femoral fractures', 'Elderly patients with femoral fractures', 'Forty-six patients']","['dexmedetomidine-fentanyl combinations', 'dexmedetomidine-ketamine', 'Dexmedetomidine-ketamine', 'Analgesia', 'dexmedetomidine-fentanyl', 'fentanyl (group F) concomitant with a loading dose of dexmedetomidine', 'intravenous ketamine', 'ketamine or fentanyl', 'dexmedetomidine']","['median pain score', 'pain relief', 'hip flexion', 'quality scores of spinal anesthesia positioning', 'pain intensity', 'pain score in lateral positioning', 'pain score', 'bradycardia, hypotension, and desaturation']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015802', 'cui_str': 'Fracture of femur'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0441840', 'cui_str': 'Group F'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0444379', 'cui_str': 'Lateral decubitus position'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}]",46.0,0.0817178,"The pain score in lateral positioning (P < .0001) and hip flexion (P < .0001) was significantly lower in group K than group F. Group K showed the significantly higher quality scores of spinal anesthesia positioning (P = .0044) than group F. Hemodynamic adverse effects, such as bradycardia, hypotension, and desaturation, were not significantly different between the groups.","[{'ForeName': 'Ki Hwa', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Inje University Haeundae Paik Hospital, Haeundaegu, Busan, Republic of Korea.'}, {'ForeName': 'Soo Jee', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Jae Hong', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Se Hun', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Hyunseong', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Dae Seok', 'Initials': 'DS', 'LastName': 'Oh', 'Affiliation': ''}, {'ForeName': 'Yong Han', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Yei Heum', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Hyojoong', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Sang Eun', 'Initials': 'SE', 'LastName': 'Lee', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020001']
3097,32443306,Prospective randomized controlled trial study of Luofengning granule in the treatment of unstable angina.,"INTRODUCTION


Although the current western treatment plans for unstable angina (UA) has been optimized in past decades, UA still is a common phenotype of acute coronary syndrome and significantly influence the quality of life and endanger lives. In China, the clinical application of Chinese herb medicine is considered as an effective approach to treating UA and widely recognized by patients. In clinical practices, we found Luofengning granule (LFN-G) could improve clinical manifestations of patients with UA, but there is lack of rigorous proof of evidence-based medicine. This trial aims to further evaluate the efficacy of LFN-G in the treatment of UA.
METHODS


A prospective, open-label, randomized, placebo-controlled clinical will be performed. A total of 60 patients diagnosed with UA will be randomly allocated to either the treatment group or the control group with a 1:1 ratio. The participants in the treatment group will receive LFN-G treatment and the participants in the control group will receive placebo. Meanwhile, both groups continue to undergo standard western medicine treatments. The duration of interventions is 4 weeks. The primary endpoint is the incidence of major cardiac adverse events, defined as a composite of recurrent angina, acute myocardial infarction (AMI), severe arrhythmia, heart failure, and cardiac death. Secondary outcomes include Seattle angina scale score, Chinese medicine syndromes and electrocardiograph (at weeks 0, 1, 2, 4), myocardial nuclides perfusion, measurement of wall motion score index and left ventricular ejection fraction, serum inflammation factors such as C-reactive protein, high sensitive-C-reactive protein, interleukin-6, matrix metalloproteinase-9, and so on (at weeks 0, 4). In addition, some biochemical indexes of blood and hematological indexes will be used to assess the safety of treatments. Any adverse effects of the treatment will be recorded.
DISCUSSION


The results of this trial will provide compelling evidence of the efficacy and safety of LFN-G for treatment of UA and preliminarily reveal the potential mechanism of how LFN-G acts. Finally, it will widen treatment options for patients with UA.",2020,"The primary endpoint is the incidence of major cardiac adverse events, defined as a composite of recurrent angina, acute myocardial infarction (AMI), severe arrhythmia, heart failure, and cardiac death.","['unstable angina', '60 patients diagnosed with UA', 'patients with UA']","['Luofengning granule', 'LFN-G treatment', 'LFN-G', 'placebo']","['Seattle angina scale score, Chinese medicine syndromes and electrocardiograph (at weeks 0, 1, 2, 4), myocardial nuclides perfusion, measurement of wall motion score index and left ventricular ejection fraction, serum inflammation factors such as C-reactive protein, high sensitive-C-reactive protein, interleukin-6, matrix metalloproteinase-9, and so on (at weeks 0, 4', 'incidence of major cardiac adverse events, defined as a composite of recurrent angina, acute myocardial infarction (AMI), severe arrhythmia, heart failure, and cardiac death']","[{'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C4324428', 'cui_str': 'Wall motion score index'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}]",60.0,0.0824664,"The primary endpoint is the incidence of major cardiac adverse events, defined as a composite of recurrent angina, acute myocardial infarction (AMI), severe arrhythmia, heart failure, and cardiac death.","[{'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing.'}, {'ForeName': 'Jun-Jun', 'Initials': 'JJ', 'LastName': 'Cai', 'Affiliation': 'Department of Hepatology, Tianjin Third Central Hospital, Tianjin.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing.'}, {'ForeName': 'Lei-Lei', 'Initials': 'LL', 'LastName': 'Liu', 'Affiliation': 'School of Traditional Chinese Medicine.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'School of Life Science.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing.'}]",Medicine,['10.1097/MD.0000000000020025']
3098,32443319,Evaluation and ultrastructural changes of amniotic membrane fragility after UVA/riboflavin cross-linking and its effects on biodegradation.,"This study aims to evaluate the changes of fragility and ultrastructure of amniotic membrane after cross-linking by UVA/riboflavin.Forty-nine fresh amniotic membranes were randomly divided into 3 groups. Eighteen were in group A (CX group) and immersed in 0.1% riboflavin solution for 10 min for UVA/riboflavin cross-linking. Sixteen were in group B (B2 group), soaked for 10 min with 0.1% riboflavin. After soaking, membranes in group A and B were transferred into corneal preservation solution. Fifteen pieces were in group C, directly into corneal preservation solution. The biomechanical and ultrastructural changes of the amniotic tissue before and after cross-linking were examined (CX group = 13, B2 group = 11, C group = 15). The amniotic membrane tissue of group A (n = 5) and B (n = 5) was transplanted into 16 eyes of the rabbits, respectively, and the dissolution time of the amniotic membrane tissue was investigated.After cross-linking, compared with the control group, the elastic modulus of the low-stress area of the amniotic membrane (Elow) was higher, while the elastic modulus of the high-stress area of the amniotic membrane (Ehigh) was lower, with no significant difference in the tensile strength. Also, the collagen fibers showed coarse and bamboo-like changes. In group A, amniotic membranes began to dissolve 4 weeks after conjunctiva transplantation, and all amniotic membranes were dissolved and absorbed 6 weeks after conjunctiva transplantation. In group B, some amniotic membrane tissues were still visible 6 weeks after conjunctiva transplantation.This study suggested that after amniotic membrane cross-linking, the brittleness was increased, the hardness was enhanced, and the morphology of the collagen fiber was changed. The cross-linked amniotic membrane showed resistance to tissue dissolution.",2020,"After cross-linking, compared with the control group, the elastic modulus of the low-stress area of the amniotic membrane (Elow) was higher, while the elastic modulus of the high-stress area of the amniotic membrane (Ehigh) was lower, with no significant difference in the tensile strength.",['Forty-nine fresh amniotic membranes'],"['UVA/riboflavin', 'soaked for 10\u200amin with 0.1% riboflavin', 'riboflavin solution for 10\u200amin for UVA/riboflavin']","['tensile strength', 'elastic modulus of the low-stress area of the amniotic membrane (Elow', 'fragility and ultrastructure of amniotic membrane', 'amniotic membrane tissues']","[{'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0002630', 'cui_str': 'Structure of amnion'}]","[{'cui': 'C0035527', 'cui_str': 'Riboflavin'}, {'cui': 'C0204774', 'cui_str': 'Soak'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C1540845', 'cui_str': 'Tensile strength'}, {'cui': 'C2350289', 'cui_str': 'Young Modulus'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0002630', 'cui_str': 'Structure of amnion'}, {'cui': 'C0302113', 'cui_str': 'Fragility'}, {'cui': 'C0041623', 'cui_str': 'ultrastructure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}]",15.0,0.0229728,"After cross-linking, compared with the control group, the elastic modulus of the low-stress area of the amniotic membrane (Elow) was higher, while the elastic modulus of the high-stress area of the amniotic membrane (Ehigh) was lower, with no significant difference in the tensile strength.","[{'ForeName': 'Chenming', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ""Jinan Second People's Hospital.""}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Du', 'Affiliation': ""Jinan Second People's Hospital.""}, {'ForeName': 'Guoying', 'Initials': 'G', 'LastName': 'Mu', 'Affiliation': 'Shandong Provincial Hospital, Jinan.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Shandong Provincial Hospital, Jinan.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': ""Jinan Second People's Hospital.""}, {'ForeName': 'Fumin', 'Initials': 'F', 'LastName': 'Long', 'Affiliation': ""People's Hospital of Taierzhuang District, Zaozhuang, China.""}, {'ForeName': 'Qiaoling', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Jinan Second People's Hospital.""}]",Medicine,['10.1097/MD.0000000000020091']
3099,32443412,Micronutrient and Inflammation Status Following One Year of Complementary Food Supplementation in 18-Month-Old Rural Bangladeshi Children: A Randomized Controlled Trial.,"Background:  Four fortified complementary food supplements (CFSs) in a randomized controlled trial (RCT) were found to improve childhood linear growth in rural Bangladesh. We hypothesized children receiving these supplements would have improved micronutrient status.  Methods:  In the RCT, we assessed hemoglobin and serum ferritin, retinol, zinc, C-reactive protein (CRP), and α-1-acid glycoprotein (AGP) at endline (18 mo) in a subsample of children ( n  = 752). The impact of supplementation on mean concentrations and the prevalence of nutrient deficiency and inflammation were evaluated using adjusted generalized estimating equation (GEE) linear and log-binomial regression models.  Results:  In the control arm at age 18 months, 13% of children were anemic (hemoglobin < 110 g/L), and 6% were iron (inflammation-adjusted ferritin < 12 μg/L), 8% vitamin A (inflammation-adjusted retinol < 0.70 μmol/L), and 5% zinc (zinc < 9.9 μmol/L) deficient. The prevalence of inflammation by CRP (>5 mg/L) and AGP (>1 g/L) was 23% and 66%, respectively, in the control group. AGP trended lower in CFS groups ( p  = 0.04), while CRP did not. Mean ferritin ( p  < 0.001) and retinol ( p  = 0.007) were higher in all supplemented groups relative to control, whereas hemoglobin improved with two of the four CFSs ( p  = 0.001), and zinc was equal or lower in supplemented groups relative to control ( p  = 0.017).  Conclusions:  CFSs improved iron status and vitamin A concentrations and lowered inflammation in a context of low underlying nutrient deficiency but high inflammation.",2020,"Mean ferritin ( p  < 0.001) and retinol ( p  = 0.007) were higher in all supplemented groups relative to control, whereas hemoglobin improved with two of the four CFSs ( p  = 0.001), and zinc was equal or lower in supplemented groups relative to control ( p  = 0.017).  ","['rural Bangladesh', '18-Month-Old Rural Bangladeshi Children']","['fortified complementary food supplements (CFSs', 'Complementary Food Supplementation']","['AGP', 'Micronutrient and Inflammation Status', 'hemoglobin and serum ferritin, retinol, zinc, C-reactive protein (CRP), and α-1-acid glycoprotein (AGP', 'mean concentrations and the prevalence of nutrient deficiency and inflammation', 'Mean ferritin', 'hemoglobin', 'prevalence of inflammation by CRP']","[{'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0422784', 'cui_str': 'Bangladeshi'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0029297', 'cui_str': 'Alpha-1- acid glycoprotein'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0017968', 'cui_str': 'Glycoprotein'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}]",,0.152667,"Mean ferritin ( p  < 0.001) and retinol ( p  = 0.007) were higher in all supplemented groups relative to control, whereas hemoglobin improved with two of the four CFSs ( p  = 0.001), and zinc was equal or lower in supplemented groups relative to control ( p  = 0.017).  ","[{'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Campbell', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe St, Baltimore, MD 21205, USA.'}, {'ForeName': 'Saijuddin', 'Initials': 'S', 'LastName': 'Shaikh', 'Affiliation': 'JiVitA Project, Gaibandha-5700, Bangladesh.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Schulze', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe St, Baltimore, MD 21205, USA.'}, {'ForeName': 'Margia', 'Initials': 'M', 'LastName': 'Arguello', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe St, Baltimore, MD 21205, USA.'}, {'ForeName': 'Hasmot', 'Initials': 'H', 'LastName': 'Ali', 'Affiliation': 'JiVitA Project, Gaibandha-5700, Bangladesh.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe St, Baltimore, MD 21205, USA.'}, {'ForeName': 'Keith P', 'Initials': 'KP', 'LastName': 'West', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe St, Baltimore, MD 21205, USA.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Christian', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe St, Baltimore, MD 21205, USA.'}]",Nutrients,['10.3390/nu12051452']
3100,32443433,The Effects on Immune Function and Digestive Health of Consuming the Skin and Flesh of Zespri ®  SunGold Kiwifruit ( Actinidia Chinensis  var.  Chinensis  'Zesy002') in Healthy and IBS-Constipated Individuals.,"Irritable bowel syndrome (IBS) is a common gastrointestinal disorder that results in constipation (IBS-C) or diarrhoea with abdominal pain, flatulence, nausea and bloating. Kiwifruit ( Actinidia  spp.) are nutrient-dense fruit with a number of reported health benefits that include lowering glycaemic response, improving cardiovascular and inflammatory biomarkers, and enhancing gut comfort and laxation. This study investigated the effect of consuming three whole Zespri ®  SunGold kiwifruit ( Actinidia chinensis  var.  chinensis  'Zesy002') with or without skin on cytokine production and immune and gut health in healthy people and those with IBS-C symptoms. This study enrolled thirty-eight participants in a 16 week randomized cross-over study (19 healthy and 19 participants with IBS-C). Participants were randomized to consume either three kiwifruit without eating the skin or three kiwifruit including the skin for 4 weeks each, with a 4 week washout in between each intervention. There was a significant decrease in the pro-inflammatory cytokine, TNF-α, for both the healthy and the IBS-C participants when they consumed whole kiwifruit and skin, and also for the healthy participants when they ate whole kiwifruit without the skin ( p  < 0.001). The kiwifruit interventions increased bowel frequency and significantly reduced the gastrointestinal symptom rating scale constipation and Birmingham IBS pain scores for both participant groups. We have demonstrated that consuming the skin of SunGold kiwifruit might have beneficial effects on gastrointestinal health that are not produced by consuming the flesh alone.",2020,"There was a significant decrease in the pro-inflammatory cytokine, TNF-α, for both the healthy and the IBS-C participants when they consumed whole kiwifruit and skin, and also for the healthy participants when they ate whole kiwifruit without the skin ( p  < 0.001).","['Healthy and IBS-Constipated Individuals', 'healthy people and those with IBS-C symptoms', 'enrolled thirty-eight participants in a 16 week randomized cross-over study (19 healthy and 19 participants with IBS-C']","['kiwifruit without eating the skin or three kiwifruit including the skin', 'consuming three whole Zespri ®  SunGold kiwifruit ( Actinidia chinensis  var']","['Irritable bowel syndrome (IBS', 'pro-inflammatory cytokine, TNF-α', 'gastrointestinal symptom rating scale constipation and Birmingham IBS pain scores', 'cytokine production and immune and gut health', 'bowel frequency']","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C0971874', 'cui_str': 'Actinidia deliciosa'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0949891', 'cui_str': 'Kiwi Plant'}]","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",38.0,0.0379497,"There was a significant decrease in the pro-inflammatory cytokine, TNF-α, for both the healthy and the IBS-C participants when they consumed whole kiwifruit and skin, and also for the healthy participants when they ate whole kiwifruit without the skin ( p  < 0.001).","[{'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Eady', 'Affiliation': 'The New Zealand Institute for Plant and Food Research Limited, Private Bag 4704, Lincoln 7608, New Zealand.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Wallace', 'Affiliation': 'The New Zealand Institute for Plant and Food Research Limited, Private Bag 4704, Lincoln 7608, New Zealand.'}, {'ForeName': 'Duncan I', 'Initials': 'DI', 'LastName': 'Hedderley', 'Affiliation': 'The New Zealand Institute for Plant and Food Research Limited, Private Bag 11600, Palmerston North 4442, New Zealand.'}, {'ForeName': 'Kerry L', 'Initials': 'KL', 'LastName': 'Bentley-Hewitt', 'Affiliation': 'The New Zealand Institute for Plant and Food Research Limited, Private Bag 11600, Palmerston North 4442, New Zealand.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Butts', 'Affiliation': 'The New Zealand Institute for Plant and Food Research Limited, Private Bag 11600, Palmerston North 4442, New Zealand.'}]",Nutrients,['10.3390/nu12051453']
3101,32443684,Early Effect of Supplemented Infant Formulae on Intestinal Biomarkers and Microbiota: A Randomized Clinical Trial.,"BACKGROUND


Post-natal gut maturation in infants interrelates maturation of the morphology, digestive, and immunological functions and gut microbiota development. Here, we explored both microbiota development and markers of gut barrier and maturation in healthy term infants during their early life to assess the interconnection of gut functions during different infant formulae regimes.
METHODS


A total of 203 infants were enrolled in this randomized double-blind controlled trial including a breastfed reference group. Infants were fed starter formulae for the first four weeks of life, supplemented with different combination of nutrients (lactoferrin, probiotics ( Bifidobacterium animal  subsp.  Lactis ) and prebiotics (Bovine Milk-derived Oligosaccharides-BMOS)) and subsequently fed the control formula up to eight weeks of life. Stool microbiota profiles and biomarkers of early gut maturation, calprotectin (primary outcome), elastase, α-1 antitrypsin (AAT) and neopterin were measured in feces at one, two, four, and eight weeks.
RESULTS


Infants fed formula containing BMOS had lower mean calprotectin levels over the first two to four weeks compared to the other formula groups. Elastase and AAT levels were closer to levels observed in breastfed infants. No differences were observed for neopterin. Global differences between the bacterial communities of all groups were assessed by constrained multivariate analysis with hypothesis testing. The canonical correspondence analysis (CCA) at genus level showed overlap between microbiota profiles at one and four weeks of age in the BMOS supplemented formula group with the breastfed reference, dominated by bifidobacteria. Microbiota profiles of all groups at four weeks were significantly associated with the calprotectin levels at 4 (CCA,  p  = 0.018) and eight weeks of age (CCA,  p  = 0.026).
CONCLUSION


A meaningful correlation was observed between changes in microbiota composition and gut maturation marker calprotectin. The supplementation with BMOS seems to favor gut maturation closer to that of breastfed infants.",2020,"RESULTS


Infants fed formula containing BMOS had lower mean calprotectin levels over the first two to four weeks compared to the other formula groups.","['healthy term infants', 'A total of 203 infants']","['nutrients (lactoferrin, probiotics ( Bifidobacterium animal  subsp', 'Supplemented Infant Formulae', 'prebiotics (Bovine Milk-derived Oligosaccharides-BMOS']","['microbiota composition and gut maturation marker calprotectin', 'Stool microbiota profiles and biomarkers of early gut maturation, calprotectin (primary outcome), elastase, α-1 antitrypsin (AAT) and neopterin', 'Intestinal Biomarkers and Microbiota', 'neopterin', 'calprotectin levels', 'mean calprotectin levels', 'Elastase and AAT levels', 'Microbiota profiles']","[{'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharide'}]","[{'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0950624', 'cui_str': 'Calprotectin'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030306', 'cui_str': 'Pancreatic elastase'}, {'cui': 'C2713669', 'cui_str': 'SERPINA5 protein, human'}, {'cui': 'C0068527', 'cui_str': 'Neopterin'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0052586', 'cui_str': 'ATA protocol'}]",203.0,0.0733011,"RESULTS


Infants fed formula containing BMOS had lower mean calprotectin levels over the first two to four weeks compared to the other formula groups.","[{'ForeName': 'Mireille', 'Initials': 'M', 'LastName': 'Castanet', 'Affiliation': 'CIC INSERM U1404, Department of Pediatric, Rouen University Hospital Charles Nicolle, 76031 Rouen, France.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Costalos', 'Affiliation': 'Department of Neonatology, Alexandra Regional General Hospital, 11528 Athens, Greece.'}, {'ForeName': 'Nadja', 'Initials': 'N', 'LastName': 'Haiden', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Hascoet', 'Affiliation': 'Department of Neonatology, Maternite Regionale, CHRU Nancy, 54035 Nancy, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Berger', 'Affiliation': 'Nestlé Research, Société des Produits Nestlé S.A., 1000 Lausanne, Switzerland.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Sprenger', 'Affiliation': 'Nestlé Research, Société des Produits Nestlé S.A., 1000 Lausanne, Switzerland.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Grathwohl', 'Affiliation': 'Nestlé Research, Société des Produits Nestlé S.A., 1000 Lausanne, Switzerland.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Brüssow', 'Affiliation': 'Nestlé Research, Société des Produits Nestlé S.A., 1000 Lausanne, Switzerland.'}, {'ForeName': 'Nanda', 'Initials': 'N', 'LastName': 'De Groot', 'Affiliation': 'SBU Nutrition, Nestlé, 1800 Vevey, Switzerland.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Steenhout', 'Affiliation': 'Nestlé Health Science, 1066 Epalinges, Switzerland.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Pecquet', 'Affiliation': 'SBU Nutrition, Nestlé, 1800 Vevey, Switzerland.'}, {'ForeName': 'Jalil', 'Initials': 'J', 'LastName': 'Benyacoub', 'Affiliation': 'Nestlé Research, Société des Produits Nestlé S.A., 1000 Lausanne, Switzerland.'}, {'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Picaud', 'Affiliation': 'Department of Neonatology, University Hospital Croix Rousse, Hospices Civils de Lyon, 69317 Lyon France.'}]",Nutrients,['10.3390/nu12051481']
3102,32444250,Variation of faecal calprotectin level within the first three months after bowel resection is predictive of endoscopic postoperative recurrence in Crohn's disease.,"BACKGROUND


Early prediction of postoperative recurrence (POR) remains a major concern in Crohn's disease (CD).
AIMS


To assess serial faecal calprotectin (Fcal) monitoring within the first three months to predict CD endoscopic POR.
METHODS


In a multicenter randomized controlled trial, CD patients received azathioprine 2.5 mg/kg/day with oral curcumin (3 g/day) or placebo. Fcal was measured at baseline, one month (M1) and M3. Endoscopic POR at M6 was defined as Rutgeerts' index ≥ i2b (central reading).
RESULTS


Among the 48 patients included, there was no significant difference of median Fcal levels at baseline (p = 0.15), M1 (p = 0.44) and M3 (p = 0.28) between patients with or without endoscopic POR at M6. Fcal kinetics during the first 3 months after surgery was significantly different between the patients with or without POR at M6 (p = 0.021). The median variation between Fcal level at baseline and M3 (ΔFcal M3-M0) was significantly higher in patients with endoscopic POR compared to those without POR (p = 0.01). ΔFcal M3-M0 >+10% demonstrated the best performances to predict endoscopic POR at M6 (AUC=0.73, sensitivity=64.7%[41.1-82.7], specificity=87.5%[68.0-96.3], negative predictive value=77.8%[57.5-91.4] and positive predictive value=78.6%[49.2-95.3]).
CONCLUSION


Fcal variation within the first three months after ileocolonic resection is a promising predictor of early endoscopic POR in CD patients.",2020,Fcal kinetics during the first 3 months after surgery was significantly different between the patients with or without POR at M6 (p = 0.021).,"[""Crohn's disease (CD"", ""Crohn's disease"", 'CD patients']","['azathioprine 2.5\u202fmg/kg/day with oral curcumin', 'ileocolonic resection', 'placebo']","['faecal calprotectin level', 'median variation between Fcal level at baseline and M3 (ΔFcal M3-M0', 'Fcal kinetics', 'serial faecal calprotectin (Fcal) monitoring', 'Endoscopic POR', 'Fcal', 'median Fcal levels']","[{'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",48.0,0.135478,Fcal kinetics during the first 3 months after surgery was significantly different between the patients with or without POR at M6 (p = 0.021).,"[{'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Boube', 'Affiliation': ""Université Clermont Auvergne, Inserm, 3iHP, CHU Clermont-Ferrand, Service d'Hépato-Gastro Entérologie, Clermont-Ferrand, France; Université Clermont Auvergne, Inserm U1071, M2iSH, USC-INRA 2018, F-63000 Clermont-Ferrand, France.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Laharie', 'Affiliation': 'Gastroenterology Department, University Hospital, Bordeaux, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Nancey', 'Affiliation': 'Hospices Civils de Lyon, Lyon-Sud hospital, Gastroenterology, Pierre Benite, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Hebuterne', 'Affiliation': 'Department of Gastroenterology and Clinical Nutrition, CHU of Nice and University of Nice Sophia-Antipolis, Nice, France.'}, {'ForeName': 'Mathurin', 'Initials': 'M', 'LastName': 'Fumery', 'Affiliation': 'Gastroenterology Department, University Hospital, Amiens, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Pariente', 'Affiliation': 'Gastroenterology Department, University Hospital, Lille, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Roblin', 'Affiliation': 'Gastroenterology Department, University Hospital, Saint-Etienne, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Peyrin-Biroulet', 'Affiliation': 'Department of Gastroenterology, CHU Nancy Brabois, Vandoeuvre les Nancy, France.'}, {'ForeName': 'Régine', 'Initials': 'R', 'LastName': 'Minet-Quinard', 'Affiliation': 'CHU Clermont-Ferrand, Laboratoire de Biochimie, Université Clermont Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'CHU Clermont-Ferrand, DRCI, Unité de Biostatistiques, Université Clermont Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Bommelaer', 'Affiliation': ""Université Clermont Auvergne, Inserm, 3iHP, CHU Clermont-Ferrand, Service d'Hépato-Gastro Entérologie, Clermont-Ferrand, France; Université Clermont Auvergne, Inserm U1071, M2iSH, USC-INRA 2018, F-63000 Clermont-Ferrand, France.""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Buisson', 'Affiliation': ""Université Clermont Auvergne, Inserm, 3iHP, CHU Clermont-Ferrand, Service d'Hépato-Gastro Entérologie, Clermont-Ferrand, France; Université Clermont Auvergne, Inserm U1071, M2iSH, USC-INRA 2018, F-63000 Clermont-Ferrand, France. Electronic address: a_buisson@hotmail.fr.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver,['10.1016/j.dld.2020.03.020']
3103,32445247,Benefits of extracorporeal shock waves for keloid treatment: A pilot study.,"Keloids are fibroproliferative skin disorders characterized by the progressive deposition of collagen. Recently, extracorporeal shock wave therapy (ESWT) has been used to treat pathologic scars. Herein, we conducted a study to compare the efficacy of intralesional injections (ILIs) of triamcinolone acetonide (TA) used alone, or in combination with ESWT for keloids. Forty patients were randomized equally into two groups in this 12-week comparative clinical trial. Group A was treated with TA ILIs and ESWT, and group B was treated with TA ILIs alone. At week 12, both groups showed acceptable improvements in nearly all dimensions evaluated, and these improvements were statistically more significant in group A. Group A showed a higher mean percentage reduction in lesion length, width, and height and in the Vancouver Scar Scale score than group B (all P < .05). More patients in group A than in group B had scores of ≥4, which indicated improvements that were good or excellent, on the patient global assessment and investigator global assessment. No serious adverse events occurred. This study suggests that ESWT could be a new, effective and acceptable adjuvant treatment option for keloids.",2020,"More patients in group A than in group B had scores of ≥4, which indicated improvements that were good or excellent, on the PGA and IGA.",['Forty patients'],"['TA ILIs and ESWT', 'extracorporeal shock wave therapy (ESWT', 'intralesional injections (ILIs) of triamcinolone acetonide (TA', 'ESWT', 'TA ILIs alone', 'extracorporeal shock waves for keloid treatment']","['lesion length, width, and height and in the VSS score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0021490', 'cui_str': 'Intralesional injection'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0442087', 'cui_str': 'Extracorporeal'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0022548', 'cui_str': 'Keloid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",40.0,0.0138915,"More patients in group A than in group B had scores of ≥4, which indicated improvements that were good or excellent, on the PGA and IGA.","[{'ForeName': 'Dong Hee', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea.'}, {'ForeName': 'Seok Hyun', 'Initials': 'SH', 'LastName': 'Han', 'Affiliation': 'Department of Dermatology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea.'}, {'ForeName': 'Ho Seok', 'Initials': 'HS', 'LastName': 'Suh', 'Affiliation': 'Department of Dermatology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea.'}, {'ForeName': 'Yu Sung', 'Initials': 'YS', 'LastName': 'Choi', 'Affiliation': 'Department of Dermatology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea.'}]",Dermatologic therapy,['10.1111/dth.13653']
3104,32446108,Cortisol awakening response in PTSD treatment: Predictor or mechanism of change.,"PTSD is associated with abnormalities in hypothalamic-pituitary-adrenal (HPA) axis activity. This includes enhanced HPA axis negative feedback, attenuated cortisol awakening response, and attenuated cortisol response to personal trauma script. Whether HPA axis function predicts treatment response or treatment related symptom reduction in PTSD remains unclear. In addition, the relative effects of different treatment modalities (i.e., medication and psychotherapy) on HPA axis is unclear. To address this gap in knowledge, the PROGrESS study examined cortisol awakening response across treatment in Veterans with chronic PTSD randomized to receive Prolonged Exposure + Placebo (PE + PLB), Sertraline + PE (SERT + PE) or Sertraline + Enhanced Medication Management (SERT + EMM). Salivary cortisol awakening response (CAR) was assessed at baseline, mid-treatment (week 6 and 12), post-treatment (week 24) and follow-up (week 36 and 52). Among males at baseline, combat veterans with PTSD showed lower CAR Area Under the Curve Increase (AUCi; M = 3.15, SD = 9.57) than Combat controls (M = 7.63, SD = 9.07; p = .02), demonstrating combat veterans with PTSD have a less responsive system than combat controls. Higher PTSD severity was also related to lower CAR AUCi (r = -0.52, p = .03). When controlling for PTSD severity, higher baseline CAR AUCi was related to attenuated reduction in PTSD and lower likelihood of high treatment response over treatment (z = -2.06, p = .04).",2020,"Higher PTSD severity was also related to lower CAR AUCi (r = -0.52, p = .03).",['Veterans with chronic PTSD'],"['Prolonged Exposure + Placebo (PE + PLB), Sertraline + PE (SERT + PE) or Sertraline + Enhanced Medication Management (SERT + EMM']","['lower CAR Area Under the Curve Increase (AUCi', 'enhanced HPA axis negative feedback, attenuated cortisol awakening response', 'cortisol awakening response', 'Salivary cortisol awakening response (CAR', 'Cortisol awakening response', 'Higher PTSD severity', 'CAR AUCi']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0730525', 'cui_str': 'Chronic post-traumatic stress disorder'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}]","[{'cui': 'C0740379', 'cui_str': 'Cortisol decreased'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0100699,"Higher PTSD severity was also related to lower CAR AUCi (r = -0.52, p = .03).","[{'ForeName': 'Sheila A M', 'Initials': 'SAM', 'LastName': 'Rauch', 'Affiliation': 'Atlanta VA Healthcare System, 1670 Clairmont Road, Decatur, GA, 30033, Georgia; Emory University School of Medicine, 12 Executive Park, 3rdFloor, Atlanta, GA, 30029, Georgia. Electronic address: sheila.a.m.rauch@emory.edu.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'King', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI, 48105, United States; University of Michigan, Department of Psychiatry, 4250 Plymouth Road, Ann Arbor, MI, 48109, United States.'}, {'ForeName': 'H Myra', 'Initials': 'HM', 'LastName': 'Kim', 'Affiliation': 'University of Michigan, Consulting for Statistics, Computing and Analytics Research, 3550 Rackham, 950 E. Washington Street, Ann Arbor, MI, 48109, United States.'}, {'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Powell', 'Affiliation': 'University of Michigan, Consulting for Statistics, Computing and Analytics Research, 3550 Rackham, 950 E. Washington Street, Ann Arbor, MI, 48109, United States.'}, {'ForeName': 'Nirmala', 'Initials': 'N', 'LastName': 'Rajaram', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI, 48105, United States.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Venners', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI, 48105, United States; National Center for PTSD, Dissemination and Training Division, 795 Willow Road, Menlo Park, CA 94025, United States.'}, {'ForeName': 'Naomi M', 'Initials': 'NM', 'LastName': 'Simon', 'Affiliation': 'New York University Medical School, Department of Psychiatry, One Park Avenue 8thFloor, New York, NY 10016, United States; Massachusetts General Hospital, Department of Psychiatry, One Bowdoin Square, 6th Floor, Boston, MA 02114, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hamner', 'Affiliation': 'Ralph H. Johnson VA Medical Center, 109 Bee Street, Charleston, SC, 29401, United States; Medical University of South Carolina, Department of Psychiatry, 67 President Street, Charleston, SC 29425, United States.'}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Liberzon', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI, 48105, United States; University of Michigan, Department of Psychiatry, 4250 Plymouth Road, Ann Arbor, MI, 48109, United States; Texas A&M Health Science Center, Department of Psychiatry and Behavioral Science, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104714']
3105,32446145,Thyroid hormones ratio is a major prognostic marker in advanced metastatic colorectal cancer: Results from the phase III randomised CORRECT trial.,"BACKGROUND


Free triiodothyronine (FT3)/free thyroxine (FT4) ratio is an index estimating the peripheral activity of thyroid hormones. In a previous experience, we identified a prognostic role for FT3/FT4 ratio in chemorefractory patients treated with regorafenib. Therefore, we planned this post hoc analysis of the phase III CORRECT trial of regorafenib versus placebo.
METHODS


Seven hundred fifty-eight out of 760 randomised patients (503 in the regorafenib and 255 in the placebo arm) were evaluable for the present analyses, based on availability of FT3 and FT4 baseline values. Co-primary objectives were to explore the predictive role of FT3/FT4 ratio in patients treated with regorafenib compared with placebo and to validate the prognostic value of FT3/FT4 ratio in the CORRECT trial.
RESULTS


For patients randomised to regorafenib, median overall survival (OS) was 4.0, 7.5 and 9.8 months in low, intermediate and high FT3/FT4 ratio subgroups, respectively. Hazard ratio (HR) for OS was 0.40 (p < 0.0001) when comparing intermediate versus low and 0.32 (p < 0.0001) when comparing high versus low FT3/FT4 ratio. In the placebo arm, median OS was 3.3, 5.6 and 7.7 months, in the three subgroups. HR for OS was 0.47 (p < 0.0001) when comparing intermediate versus low and 0.33 (p < 0.0001) when comparing high versus low. FT3/FT4 ratio retained its association with OS in the multivariate model in both arms.
CONCLUSIONS


While rejecting the predictive effect of baseline FT3/FT4 ratio, present data strengthen the prognostic role of the ratio, pave the way for direct clinical application, underline the need for a better biological understanding and suggest possible therapeutic implications for thyroid hormones.",2020,"For patients randomised to regorafenib, median overall survival (OS) was 4.0, 7.5 and 9.8 months in low, intermediate and high FT3/FT4 ratio subgroups, respectively.","['Seven hundred fifty-eight out of 760 randomised patients (503 in the regorafenib and 255 in the', 'advanced metastatic colorectal cancer']","['regorafenib', 'regorafenib versus placebo', 'Thyroid hormones ratio', 'triiodothyronine (FT3)/free thyroxine ', 'placebo']","['Hazard ratio (HR) for OS', 'median OS', 'median overall survival (OS', 'availability of FT3 and FT4 baseline values', 'FT3/FT4 ratio']","[{'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}]","[{'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0041014', 'cui_str': 'liothyronine'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0560014', 'cui_str': 'ft3'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",760.0,0.121696,"For patients randomised to regorafenib, median overall survival (OS) was 4.0, 7.5 and 9.8 months in low, intermediate and high FT3/FT4 ratio subgroups, respectively.","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pasqualetti', 'Affiliation': 'Department of Clinical & Experimental Medicine, Geriatrics Unit, University of Pisa, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Schirripa', 'Affiliation': 'Department of Oncology, Unit of Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Dochy', 'Affiliation': 'Bayer Healthcare Pharmaceuticals, Whippany, NJ, USA.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Fassan', 'Affiliation': 'Department of Medicine (DIMED), Surgical Pathology & Cytopathology Unit, University of Padua, Padua, Italy.'}, {'ForeName': 'Pina', 'Initials': 'P', 'LastName': 'Ziranu', 'Affiliation': 'Department of Medical Science and Public Health, Medical Oncology Unit, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Puzzoni', 'Affiliation': 'Department of Medical Science and Public Health, Medical Oncology Unit, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Scartozzi', 'Affiliation': 'Department of Medical Science and Public Health, Medical Oncology Unit, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Alberti', 'Affiliation': 'Department of Oncology, Unit of Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Department of Oncology, Unit of Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.'}, {'ForeName': 'Vittorina', 'Initials': 'V', 'LastName': 'Zagonel', 'Affiliation': 'Department of Oncology, Unit of Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Monzani', 'Affiliation': 'Department of Clinical & Experimental Medicine, Geriatrics Unit, University of Pisa, Italy.'}, {'ForeName': 'Fotios', 'Initials': 'F', 'LastName': 'Loupakis', 'Affiliation': 'Department of Oncology, Unit of Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy. Electronic address: fotios.loupakis@iov.veneto.it.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.04.023']
3106,32449452,A Randomized Controlled Trial of a Motivational Interviewing Intervention to Improve Whole-Person Lifestyle.,"The purpose of this randomized controlled trial was to examine the effects of a motivational interviewing intervention to improve whole-person lifestyle and reduce cardiovascular disease risk profile. A sample of 111 adults with type 2 diabetes and/or hypertension was recruited from a primary care physician practice. The intervention was facilitated by a program specialist trained in motivational interviewing. Outcomes included body mass index, cholesterol, hemoglobin A1c, blood pressure, waist circumference, wellness scores, and substance use. Differences in the changes in body mass index and waist circumference existed between the intervention and control groups after 6 months. In the intervention group, the proportion of high wellness scores increased after the program. A whole-person lifestyle intervention with motivational interviewing for patients with metabolic syndrome can improve one's health in terms of components in the cardiovascular disease risk profile, as well as overall wellness. Efforts to improve the health of these patients may incorporate motivational interviewing to guide goal setting and address mental and spiritual health in addition to physical health.",2020,"A whole-person lifestyle intervention with motivational interviewing for patients with metabolic syndrome can improve one's health in terms of components in the cardiovascular disease risk profile, as well as overall wellness.","['111 adults with type 2 diabetes and/or hypertension was recruited from a primary care physician practice', 'patients with metabolic syndrome']","['motivational interviewing intervention', 'Motivational Interviewing Intervention', 'program specialist trained in motivational interviewing']","['cardiovascular disease risk profile', 'body mass index, cholesterol, hemoglobin A1c, blood pressure, waist circumference, wellness scores, and substance use', 'proportion of high wellness scores', 'body mass index and waist circumference']","[{'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0205250', 'cui_str': 'High'}]",111.0,0.0298626,"A whole-person lifestyle intervention with motivational interviewing for patients with metabolic syndrome can improve one's health in terms of components in the cardiovascular disease risk profile, as well as overall wellness.","[{'ForeName': 'Amanda T', 'Initials': 'AT', 'LastName': 'Sawyer', 'Affiliation': 'AdventHealth Orlando, Orlando, FL, USA.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Wheeler', 'Affiliation': 'AdventHealth Orlando, Orlando, FL, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Jennelle', 'Affiliation': 'AdventHealth Orlando, Orlando, FL, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Pepe', 'Affiliation': 'AdventHealth Orlando, Orlando, FL, USA.'}, {'ForeName': 'Patricia Stearnes', 'Initials': 'PS', 'LastName': 'Robinson', 'Affiliation': 'AdventHealth Orlando, Orlando, FL, USA.'}]",Journal of primary care & community health,['10.1177/2150132720922714']
3107,32446752,Adding Financial Incentives to Online Group-Based Behavioral Weight Control: An RCT.,"INTRODUCTION


Internet-delivered behavioral weight control is promising for expanding the reach and availability of weight management, but online programs produce lower weight losses than typically achieved in person. Financial incentives have been shown to increase weight losses. This study examined whether adding financial incentives for self-monitoring and achieving target weight losses increases weight losses attained in a fully online, group-based behavioral weight management program compared with the same program alone.
STUDY DESIGN


This study was an RCT.
SETTING/PARTICIPANTS


Adults with overweight and obesity (n=418; 91% female; 28% minority) were recruited from 2 clinical centers.
INTERVENTION


The intervention was a 24-session online group-based behavioral weight control program with weekly synchronous chat sessions (Internet-only) or the same program with weekly financial incentives for self-monitoring body weight and dietary intake daily and for achieving target weight losses at 2 and 6 months (Internet + incentives).
MAIN OUTCOME MEASURES


This study measured weight loss at 6 months and treatment engagement (attendance, self-monitoring of body weight, dietary intake, and physical activity). Data were collected between February 2016 and August 2018, and analyses were completed in 2019.
RESULTS


Participants randomized to the Internet + incentives group lost more weight (-6.4 [SD=5.5] kg) than those in the Internet-only group (-4.7 [SD=6.6] kg; p<0.01). Further, a higher proportion of the Internet + incentives group achieved ≥5% weight loss (55%) than those in the Internet-only group (40%; p<0.05). Treatment engagement was higher in the Internet + incentives condition, with greater self-monitoring of behaviors targeted by incentives, as well as higher rates of behaviors not targeted and higher self-reported physical activity. Study retention was higher among those in the Internet + incentives condition (91%) than those in the Internet-only condition (81%; p=0.003).
CONCLUSIONS


Adding financial incentives to a program delivered fully online increases weight losses compared with the program alone and can achieve weight losses comparable to in-person programs, offering potential for substantial geographic reach.
TRIAL REGISTRATION


This study is registered at www.clinicaltrials.gov NCT02688621.",2020,"Study retention was higher among those in the Internet + incentives condition (91%) than those in the Internet-only condition (81%; p=0.003).
","['Adults with overweight and obesity (n=418; 91% female; 28% minority) were recruited from 2 clinical centers', 'Data were collected between February 2016 and August 2018, and analyses were completed in 2019']",['24-session online group-based behavioral weight control program with weekly synchronous chat sessions (Internet-only) or the same program with weekly financial incentives for self-monitoring body weight and dietary intake daily and for achieving target weight losses at 2 and 6 months (Internet\u202f+\u202fincentives'],"['weight', 'Study retention', 'weight loss at 6 months and treatment engagement (attendance, self-monitoring of body weight, dietary intake, and physical activity', 'weight losses', 'weight loss']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0124604', 'cui_str': 'Catha edulis'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1272247', 'cui_str': 'Target weight'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0376283,"Study retention was higher among those in the Internet + incentives condition (91%) than those in the Internet-only condition (81%; p=0.003).
","[{'ForeName': 'Delia S', 'Initials': 'DS', 'LastName': 'West', 'Affiliation': 'Arnold School of Public Health, University of South Carolina, Columbia, South Carolina. Electronic address: westds@mailbox.sc.edu.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Krukowski', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Sciences Center, Memphis, Tennessee.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Finkelstein', 'Affiliation': 'Duke-NUS Medical School and Duke University Global Health Institute, Singapore and Durham, North Carolina.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Stansbury', 'Affiliation': 'Arnold School of Public Health, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'Doris E', 'Initials': 'DE', 'LastName': 'Ogden', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Courtney M', 'Initials': 'CM', 'LastName': 'Monroe', 'Affiliation': 'Arnold School of Public Health, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'Chelsea A', 'Initials': 'CA', 'LastName': 'Carpenter', 'Affiliation': 'Arnold School of Public Health, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Naud', 'Affiliation': 'Biomedical Statistics, Larner College of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Jean R', 'Initials': 'JR', 'LastName': 'Harvey', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Vermont, Burlington, Vermont.'}]",American journal of preventive medicine,['10.1016/j.amepre.2020.03.015']
3108,32446979,"Xinyue Capsule in patients with stable coronary artery disease after percutaneous coronary intervention: a multicenter, randomized, placebo-controlled trial.","BACKGROUND


Xinyue capsule, a patented Chinese herbal medicine, has been used to manage coronary artery disease (CAD) for over a decade in China, but whether it can further reduce risk of cardiovascular events beyond conventional treatment is unknown.
METHODS


In this multicenter, randomized, placebo-controlled trial, we randomly assigned patients with stable CAD who underwent percutaneous coronary intervention (PCI) within the preceding 3-12 months to receive Xinyue capsule (100 mg panax quinquefolius saponins, three times a day) or placebo for 24 weeks in addition to conventional treatment. The primary endpoint was a composite that included cardiac death, nonfatal myocardial infarction and urgent revascularization with either PCI or coronary artery bypass grafting. The secondary composite endpoints included stroke, re-hospitalization due to acute coronary syndrome (ACS), pulmonary embolism, peripheral vascular events and all-cause mortality. Quality of life was assessed using a 36-item Short-Form Health Survey (SF-36).
RESULTS


A total of 1054 participants were included in the analyses. The median follow up was 1 year. The primary endpoint events occurred in 16 patients (3.02%) in the Xinyue group and 34 patients (6.49%) in the placebo group (hazard ratio [HR] 0.455, 95% confidence interval [CI] 0.25 to 0.825; P = 0.009). Secondary end-point events occurred in 5.47% of patients in the Xinyue group and 10.31% in the placebo group (HR 0.515, 95% CI 0.328 to 0.809; P = 0.004). SF-36 subscale scores at 12 months were significantly higher in the Xinyue group than placebo group for general health (P = 0.048) and vitality (P = 0.008).
CONCLUSIONS


In patients with stable CAD after PCI within the preceding 3 to 12 months, Xinyue capsule added on conventional treatment reduced the incidence of primary composite endpoint (cardiac death, nonfatal myocardial infarction and urgent revascularization).",2020,"SF-36 subscale scores at 12 months were significantly higher in the Xinyue group than placebo group for general health (P = 0.048) and vitality (P = 0.008).
","['patients with stable CAD who underwent', 'A total of 1054 participants were included in the analyses', 'patients with stable coronary artery disease after percutaneous coronary intervention']","['percutaneous coronary intervention (PCI', 'Xinyue capsule (100\u2009mg panax quinquefolius saponins, three times a day) or placebo', 'Xinyue Capsule', 'placebo']","['SF-36 subscale scores', 'Secondary end-point events', 'Quality of life', 'composite that included cardiac death, nonfatal myocardial infarction and urgent revascularization with either PCI or coronary artery bypass grafting', 'stroke, re-hospitalization due to acute coronary syndrome (ACS), pulmonary embolism, peripheral vascular events and all-cause mortality', 'incidence of primary composite endpoint (cardiac death, nonfatal myocardial infarction and urgent revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3651791', 'cui_str': 'Panax quinquefolius whole extract'}, {'cui': 'C0036189', 'cui_str': 'Saponins'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]",1054.0,0.559087,"SF-36 subscale scores at 12 months were significantly higher in the Xinyue group than placebo group for general health (P = 0.048) and vitality (P = 0.008).
","[{'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Guo', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Peili', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Jianpeng', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Changgeng', 'Initials': 'C', 'LastName': 'Fu', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Qiaoning', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Zhuye', 'Initials': 'Z', 'LastName': 'Gao', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Mingjun', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': 'The First Affiliated Hospital of the Henan University of Chinese Medicine, Henan 450046, China.'}, {'ForeName': 'Shuzheng', 'Initials': 'S', 'LastName': 'Lv', 'Affiliation': 'Beijing Anzhen Hospital, Beijing Institute of Respiratory Medicine, Capital Medical University, Beijing 10029, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'The First Affiliated Hospital of Jilin University of Traditional Chinese Medicine, Changchun 130021, China.'}, {'ForeName': 'Tianchang', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Naval General Hospital, Beijing 100048, China.'}, {'ForeName': 'Dazhuo', 'Initials': 'D', 'LastName': 'Shi', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China. Electronic address: shidazhuo@cacms.cn.'}, {'ForeName': 'For The Xy', 'Initials': 'FTX', 'LastName': 'Working Group', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}]",Pharmacological research,['10.1016/j.phrs.2020.104883']
3109,32447224,Shorter sleep duration is associated with lower GABA levels in the anterior cingulate cortex.,"BACKGROUND


Alterations in the levels of gamma-aminobutyric acid (GABA) and glutamate + glutamine (Glx), which are major inhibitory and excitatory neurotransmitters, respectively, are frequently associated with insomnia. Previous reports also suggested the involvement of the anterior cingulate cortex (ACC) and medial prefrontal cortex (mPFC) in insomnia and shorter sleep duration. In the current study, we investigated whether the GABA and Glx levels were altered in the ACC/mPFC in subclinical insomnia while focusing on the sleep duration.
METHODS


We examined levels of GABA and Glx in the ACC/mPFC of the brain with magnetic resonance spectroscopy in 166 individuals with subjective sleep complaints but without a diagnosis of insomnia. Participants were divided into two groups according to sleep duration (≥6 h/night: n = 79 vs. < 6 h/night: n = 74), which was measured using a wrist-worn actigraphy. Working memory function and overall subjective sleep quality were assessed with a computerized neuropsychological test and self-report questionnaire, respectively.
RESULTS


GABA levels in the ACC/mPFC were lower in the shorter sleep duration group relative to the longer sleep duration group (t = -2.21, p = 0.03). Glx levels did not differ between the two groups (t = -0.20, p = 0.84). Lower GABA levels were associated with lower spatial working memory performance in the shorter sleep duration group (β = -0.21, p = 0.03), but not the longer sleep duration group (β = 0.04, p = 0.72).
CONCLUSION


Shorter sleep duration was associated with lower GABA levels in the ACC/mPFC. These findings may provide insight into the underlying mechanisms of impaired working memory function related to insomnia and sleep loss.",2020,"Glx levels did not differ between the two groups (t = -0.20, p = 0.84).",['166 individuals with subjective sleep complaints but without a diagnosis of insomnia'],['magnetic resonance spectroscopy'],"['Shorter sleep duration', 'anterior cingulate cortex (ACC) and medial prefrontal cortex (mPFC) in insomnia and shorter sleep duration', 'Glx levels', 'mPFC', 'Working memory function and overall subjective sleep quality', 'GABA levels', 'GABA and Glx levels', 'Lower GABA levels', 'spatial working memory performance']","[{'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",166.0,0.0321215,"Glx levels did not differ between the two groups (t = -0.20, p = 0.84).","[{'ForeName': 'Shinwon', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Ilhyang', 'Initials': 'I', 'LastName': 'Kang', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Richard A E', 'Initials': 'RAE', 'LastName': 'Edden', 'Affiliation': 'Russell H. Morgan Department of Radiology and Radiological Science, The Johns Hopkins University School of Medicine, Baltimore, MD, USA; F.M. Kirby Research Center for Functional Brain Imaging, Kennedy Krieger Institute, Baltimore, MD, USA.'}, {'ForeName': 'Eun', 'Initials': 'E', 'LastName': 'Namgung', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Jinsol', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea; Department of Brain and Cognitive Sciences, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Jungyoon', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea; Department of Brain and Cognitive Sciences, Ewha W. University, Seoul, South Korea. Electronic address: jungyoon.kimm@ewha.ac.kr.'}]",Sleep medicine,['10.1016/j.sleep.2020.02.018']
3110,32445609,Dependency of respiratory system mechanics on positive end-expiratory pressure and recruitment maneuvers in lung healthy pediatric patients-A randomized crossover study.,"BACKGROUND


The lungs of pediatric patients are subjected to tidal derecruitment during mechanical ventilation and in contrast to adult patients this unfavorable condition cannot be resolved with small c increases. This raises the question if higher end-expiratory pressure increases or recruitment maneuvers may resolve tidal derecruitment in pediatric patients.
AIMS


We hypothesized that higher PEEP resolves tidal derecruitment in pediatric patients and that recruitment maneuvers between the pressure changes support the improvement of respiratory system mechanics.
METHODS


The effects of end-expiratory pressure changes from 3 to 7 cmH 2  O and vice versa without and with intermediate recruitment maneuvers on respiratory system mechanics and regional ventilation were investigated in 57 mechanically ventilated pediatric patients. The intratidal respiratory system compliance was determined from volume and pressure data before and after PEEP changes and categorized to indicate tidal derecruitment.
RESULTS


Tidal derecruitment occurred comparably frequently at PEEP 3 cmH 2  O without (13 out of 14 cases) and with recruitment maneuver (14 out of 14 cases) and at PEEP 7 cmH 2  O without (13 out of 14 cases) and with recruitment maneuver (13 out of 15 cases).
CONCLUSIONS


We conclude that contrary to our hypothesis, PEEP up to 7 cmH 2  O is not sufficient to resolve tidal derecruitment and that recruitment maneuvers may be dispensable in mechanically ventilated pediatric patients.",2020,The effects of end-expiratory pressure changes from 3 to 7 cm H 2  O and vice versa without and with intermediate recruitment maneuvers on respiratory system mechanics and regional ventilation were investigated in 57 mechanically ventilated pediatric patients.,"['mechanically ventilated pediatric patients', 'lung healthy pediatric patients', 'pediatric patients', '57 mechanically ventilated pediatric patients']",['end-expiratory pressure changes from 3 to 7 cm\xa0H 2  O and vice versa without and with intermediate recruitment maneuvers'],"['respiratory system mechanics and regional ventilation', 'Tidal derecruitment']","[{'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}]","[{'cui': 'C0428720', 'cui_str': 'End-expiratory pressure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}]","[{'cui': 'C0035237', 'cui_str': 'Structure of respiratory system'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]",57.0,0.0716177,The effects of end-expiratory pressure changes from 3 to 7 cm H 2  O and vice versa without and with intermediate recruitment maneuvers on respiratory system mechanics and regional ventilation were investigated in 57 mechanically ventilated pediatric patients.,"[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schumann', 'Affiliation': 'Department of Anesthesiology and Critical Care, Faculty of Medicine, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Feth', 'Affiliation': 'Department of Anesthesiology and Critical Care, Faculty of Medicine, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Borgmann', 'Affiliation': 'Department of Anesthesiology and Critical Care, Faculty of Medicine, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Wirth', 'Affiliation': 'Department of Anesthesiology and Critical Care, Faculty of Medicine, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany.'}]",Paediatric anaesthesia,['10.1111/pan.13927']
3111,32446170,"Independent and combined effect of home-based progressive resistance training and nutritional supplementation on muscle strength, muscle mass and physical function in dynapenic older adults with low protein intake: A randomized controlled trial.","BACKGROUND


With the aging phenomenon, there is growing interest in developing effective strategies to counteract dynapenia, the age-related loss of muscle strength. The positive effect of progressive resistance training on muscle strength is well known, however, the effect of nutritional supplementation or its synergistic effect along with exercise on muscle strength is not a consensus in the literature, especially in populations with low protein intake.
METHODS


We analyzed the muscle strength (handgrip strength and sit-to-stand test), muscle mass, body mass index, insulin resistance, and physical function (gait speed, timed up & go test, and single-leg-stance test) of 69 dynapenic older adults with low protein intake, before and after the intervention period of three months. The participants were randomly allocated into four groups: resistance training, supplementation, resistance training plus supplementation, and control.
RESULTS


There was a significant group x time interaction on the following outcome measures: handgrip strength (p <  0.001), gait speed (p =  0.023), and sit-to-stand test (p <  0.001). Considering the outcomes that showed a significant difference between and within groups, only the resistance training group and the resistance training plus supplementation group showed a large effect size in handgrip strength, gait speed, and sit-to-stand test, whereas the supplementation group showed a moderate effect size in gait speed. After the intervention period, there was no difference between the resistance training and the resistance training plus supplementation groups.
CONCLUSION


This study reinforces the value of resistance training in improving muscle strength. The nutritional supplementation added no further benefits in this specific population. Registration number at the Brazilian registry of clinical trials: RBR-4HRQJF.",2020,"There was a significant group x time interaction on the following outcome measures: handgrip strength (p <  0.001), gait speed (p =  0.023), and sit-to-stand test (","['dynapenic older adults with low protein intake', '69 dynapenic older adults with low protein intake, before and after the intervention period of three months']","['home-based progressive resistance training and nutritional supplementation', 'progressive resistance training', 'resistance training, supplementation, resistance training plus supplementation, and control']","['muscle strength (handgrip strength and sit-to-stand test), muscle mass, body mass index, insulin resistance, and physical function (gait speed, timed up & go test, and single-leg-stance test', 'gait speed', 'sit-to-stand test ', 'muscle strength, muscle mass and physical function', 'handgrip strength', 'moderate effect size in gait speed', 'handgrip strength, gait speed, and sit-to-stand test']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0242972', 'cui_str': 'Low protein diet'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4082119', 'cui_str': 'Three months'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",,0.0382378,"There was a significant group x time interaction on the following outcome measures: handgrip strength (p <  0.001), gait speed (p =  0.023), and sit-to-stand test (","[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'de Carvalho Bastone', 'Affiliation': 'Postgraduate Program in Reabilitation and Functional Performance, Department of Physical Therapy - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: ale.bastone@gmail.com.'}, {'ForeName': 'Luciana Neri', 'Initials': 'LN', 'LastName': 'Nobre', 'Affiliation': 'Department of Nutrition - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: lunerinobre@yahoo.com.br.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'de Souza Moreira', 'Affiliation': 'Postgraduate Program in Public Health - Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil. Electronic address: onurbsm@yahoo.com.br.'}, {'ForeName': 'Iramaya Francielle', 'Initials': 'IF', 'LastName': 'Rosa', 'Affiliation': 'Department of Physical Therapy - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: iramayafranciellerosa@hotmail.com.'}, {'ForeName': 'Gabrielle Bemfica', 'Initials': 'GB', 'LastName': 'Ferreira', 'Affiliation': 'Department of Nutrition - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: gabi_bferreira@hotmail.com.'}, {'ForeName': 'Dayane Deyse Lee', 'Initials': 'DDL', 'LastName': 'Santos', 'Affiliation': 'Department of Physical Therapy - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: dayanedls@hotmail.com.'}, {'ForeName': 'Nancy Krysna Sancha Silva', 'Initials': 'NKSS', 'LastName': 'Monteiro', 'Affiliation': 'Department of Nutrition - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: krysnancymonteiro@gmail.com.'}, {'ForeName': 'Michelle Dullya', 'Initials': 'MD', 'LastName': 'Alves', 'Affiliation': 'Department of Nutrition - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: mih.dullya@gmail.com.'}, {'ForeName': 'Rômulo Amaral', 'Initials': 'RA', 'LastName': 'Gandra', 'Affiliation': 'Department of Physical Therapy - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: romulogandra@yahoo.com.br.'}, {'ForeName': 'Elane Marinho', 'Initials': 'EM', 'LastName': 'de Lira', 'Affiliation': 'Postgraduate Program in Reabilitation and Functional Performance, Department of Physical Therapy - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: e.lira.fisio@gmail.com.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104098']
3112,32446172,Effects of 'participatory group-based care management' on wellbeing of older people living alone: a randomized controlled trial.,"BACKGROUND AND OBJECTIVES


More knowledge is needed of the effectiveness of complex interventions that aim to promote the wellbeing of older people. This study examines the effects of 'participatory group-based care management' conducted among community-dwelling older adults living alone in Central and Eastern Finland. The intervention aimed to promote wellbeing and quality of life (QoL) using a needs-based and participatory approach.
METHODS


The study was carried out as a randomized control trial (intervention group n = 185, control group n = 207). In this article, baseline and 6-month follow-up surveys were used. QoL (WHOQOL-Bref instrument), loneliness (Revised UCLA Loneliness Scale; single-item question), and trust (two items of generalized trust and six items of institutional trust) were used as outcome measurements, and generalized estimating equations (GEE) modeling as the analysis method. Both per-protocol and intention-to-treat analyses were applied.
RESULTS


According to the per-protocol analysis, the intervention had no effects on QoL. Loneliness decreased among older people with poor QoL at the baseline. Additionally, the intervention enhanced trust in other people and some dimensions of institutional trust. The intention-to-treat analysis did not result in any significant effects on QoL or loneliness, but some small positive changes in institutional trust were found.
CONCLUSIONS


Based on some evidence of small positive effects, the intervention may be beneficial in alleviating loneliness and enhancing trust among older people living alone. Because of the contradictory results, more research is needed to examine the complexity of 'participatory group-based care management´ from the perspective of process evaluation.",2020,"According to the per-protocol analysis, the intervention had no effects on QoL. Loneliness decreased among older people with poor QoL at the baseline.","['older people', 'community-dwelling older adults living alone in Central and Eastern Finland', 'older people living alone']",['participatory group-based care management'],"['QoL or loneliness', 'wellbeing and quality of life (QoL', 'QoL. Loneliness', 'QoL (WHOQOL-Bref instrument), loneliness (Revised UCLA Loneliness Scale; single-item question), and trust (two items of generalized trust and six items of institutional trust']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439044', 'cui_str': 'Lives alone'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0016132', 'cui_str': 'Finland'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",,0.0856593,"According to the per-protocol analysis, the intervention had no effects on QoL. Loneliness decreased among older people with poor QoL at the baseline.","[{'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Ristolainen', 'Affiliation': 'Department of Social Sciences, University of Eastern Finland, Finland.'}, {'ForeName': 'Sirpa', 'Initials': 'S', 'LastName': 'Kannasoja', 'Affiliation': 'Department of Social Sciences and Philosophy, University of Jyväskylä, Finland.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Tiilikainen', 'Affiliation': 'Department of Social Sciences, University of Eastern Finland, Finland.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Hakala', 'Affiliation': 'Department of Social Sciences and Philosophy, University of Jyväskylä, Finland.'}, {'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Närhi', 'Affiliation': 'Department of Social Sciences and Philosophy, University of Jyväskylä, Finland.'}, {'ForeName': 'Sari', 'Initials': 'S', 'LastName': 'Rissanen', 'Affiliation': 'Department of Social Sciences, University of Eastern Finland, Finland.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104095']
3113,32446176,"Efficacy and safety of safinamide as an add-on therapy to L-DOPA for patients with Parkinson's disease: A randomized, double-blind, placebo-controlled, phase II/III study.","INTRODUCTION


Safinamide is a reversible and selective monoamine oxidase-B (MAO-B) and sodium channel inhibitor with demonstrated efficacy in mid-to late-stage Parkinson's disease (PD) as an adjunct to l-DOPA. This study aimed to confirm the efficacy and safety of safinamide in PD patients with wearing-off.
METHODS


This 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study included Japanese PD patients with wearing-off on l-DOPA treatment. Patients were randomized to receive placebo (P), safinamide 50 mg/day (S50), or safinamide 100 mg/day (S100). The primary endpoint was the change from baseline in mean daily ON-time without troublesome dyskinesias (ON-time). Other measures included the changes in mean daily OFF-time, the unified Parkinson's disease rating scale (UPDRS) score, and the PDQ-39 summary index.
RESULTS


A total of 406 subjects were randomized, of whom 349 completed the study. Baseline characteristics were balanced. Differences in the change of mean daily ON-time at Week 24 compared with the P group were 1.39 h (p = 0.0002) in the S50 group and 1.66 h (p < 0.0001) in the S100 group. Changes from baseline in mean daily OFF-time, UPDRS Part II total score (OFF phase), UPDRS Part III total score (ON phase), and UPDRS Part I also showed significant improvements. Adverse events occurred in 58.9%, 60.2%, and 61.4% of the P, S50, and S100 groups, respectively. The most common adverse drug reactions were dyskinesias (2.1%, 8.3%, and 10.6%) and visual hallucinations (1.4%, 3.0%, and 4.5%).
CONCLUSION


As an adjunct to l-DOPA, safinamide safely increased ON-time and improved PD symptoms/signs in PD patients with wearing-off.",2020,Differences in the change of mean daily ON-time at Week 24 compared with the P group were 1.39 h (p = 0.0002) in the S50 group and 1.66 h (p < 0.0001) in the S100 group.,"[""patients with Parkinson's disease"", 'PD patients with wearing-off', 'Japanese PD patients with wearing-off on l-DOPA treatment', 'A total of 406 subjects were randomized, of whom 349 completed the study']","['sodium channel inhibitor', 'safinamide', 'placebo (P), safinamide 50\xa0mg/day (S50), or safinamide 100\xa0mg/day (S100', 'placebo']","['Adverse events', 'dyskinesias', 'Efficacy and safety', 'mean daily OFF-time, UPDRS Part II total score (OFF phase), UPDRS Part III total score (ON phase), and UPDRS Part', 'visual hallucinations', 'mean daily ON-time', 'efficacy and safety', ""mean daily OFF-time, the unified Parkinson's disease rating scale (UPDRS) score, and the PDQ-39 summary index"", 'change from baseline in mean daily ON-time without troublesome dyskinesias (ON-time', 'ON-time and improved PD symptoms/signs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0872271', 'cui_str': 'Sodium channel blocker'}, {'cui': 'C1098261', 'cui_str': 'safinamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4475891', 'cui_str': 'safinamide 50 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4475900', 'cui_str': 'safinamide 100 MG'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0233763', 'cui_str': 'Visual hallucinations'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220912', 'cui_str': 'signs'}]",406.0,0.175291,Differences in the change of mean daily ON-time at Week 24 compared with the P group were 1.39 h (p = 0.0002) in the S50 group and 1.66 h (p < 0.0001) in the S100 group.,"[{'ForeName': 'Nobutaka', 'Initials': 'N', 'LastName': 'Hattori', 'Affiliation': 'Department of Neurology, Juntendo University School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8431, Japan. Electronic address: nhattori@juntendo.ac.jp.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Tsuboi', 'Affiliation': 'Department of Neurology, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan. Electronic address: tsuboi@cis.fukuoka-u.ac.jp.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Yamamoto', 'Affiliation': 'Meiji Seika Pharma Co., Ltd., 2-4-16 Kyobashi, Chuo-ku, Tokyo, 104-8002, Japan. Electronic address: akihiko.yamamoto@meiji.com.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Sasagawa', 'Affiliation': 'Meiji Seika Pharma Co., Ltd., 2-4-16 Kyobashi, Chuo-ku, Tokyo, 104-8002, Japan. Electronic address: yuuji.sasagawa@meiji.com.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nomoto', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Graduate School of Medicine, Ehime University, Shizugawa, Tohon, Ehime, 791-0295, Japan; Saiseikai Imabari Center for Health and Welfare, 7-6-1 Kitamura, Imabari, Ehime, 799-1592, Japan. Electronic address: nomoto@m.ehime-u.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.04.012']
3114,32446921,Clinical Assessment of Perfusion Techniques During Surgical Repair of Coarctation of Aorta With Aortic Arch Hypoplasia in Neonates: A Pilot Prospective Randomized Study.,"We aimed to compare the safety and efficacy of 3 perfusion methods primarily used in aortic arch reconstruction in infants, namely, deep hypothermic circulatory arrest, selective antegrade cerebral perfusion, and double arterial cannulation. Forty-five infants with aortic arch obstruction and biventricular anatomy were enrolled in this pilot prospective study (ClinicalTrials.gov registration number: NCT02835703). Patients were randomly assigned into 3 groups according to the perfusion strategy (deep hypothermic circulatory arrest, n = 15; selective antegrade cerebral perfusion, n = 15; double arterial cannulation, n = 15). The primary composite endpoint was the incidence of adverse events in the early postoperative period (acute kidney injury [KDIGO criteria], new brain magnetic resonance imaging (MRI) findings, and in-hospital mortality). The secondary endpoints were intensive care unit length of stay, vasoactive-inotropic score index, and cardiopulmonary bypass duration. All patients underwent aortic arch reconstruction under cardiopulmonary bypass and were monitored with near-infrared spectroscopy during surgery. No significant differences in the baseline characteristics and cardiopulmonary bypass duration were observed among the groups. The incidence of unfavorable events was lower in the double arterial cannulation group (P = 0.041). Acute kidney injury was observed in 8, 6, and 5 patients from the deep hypothermic circulatory arrest, selective antegrade cerebral perfusion, and double arterial cannulation groups, respectively (P = 0.64). Twelve patients from the deep hypothermic circulatory arrest group had new brain MRI findings (P = 0.019). There were 5 in-hospital deaths with no significant difference among the groups (P = 0.70). The ""head"" and ""lumbar"" values on near-infrared spectroscopy during aortic arch reconstruction were significantly higher in the selective antegrade cerebral perfusion and double arterial cannulation groups than in the deep hypothermic circulatory arrest group. Patients in the double arterial cannulation group had a significantly lower vasoactive-inotropic score index 24 hours postoperatively than the deep hypothermic circulatory arrest group (P = 0.03). Vasoactive-inotropic score index >12 was found to be a risk factor for acute kidney injury and early mortality. Continuous regional perfusion during aortic arch reconstruction decreases the risk of new brain MRI findings in infants and the need for postoperative inotropic support. Although values of near-infrared spectroscopy during the procedure were significantly higher with continuous perfusion strategies, these methods do not reduce the acute kidney injury incidence compared to that with deep hypothermic circulatory arrest. Double arterial cannulation significantly reduces the need for inotropic support.",2020,Patients in the double arterial cannulation group had a significantly lower vasoactive-inotropic score index 24 hours postoperatively than the deep hypothermic circulatory arrest group (p=0.03).,"['surgical repair of coarctation of aorta with aortic arch hypoplasia in neonates', 'Forty-five infants with aortic arch obstruction and biventricular anatomy']","['perfusion strategy (deep hypothermic circulatory arrest, n=15; selective antegrade cerebral perfusion, n=15; double arterial cannulation', 'aortic arch reconstruction under cardiopulmonary bypass']","['hospital deaths', 'new brain MRI findings', 'intensive care unit length of stay, vasoactive-inotropic score index, and cardiopulmonary bypass duration', 'safety and efficacy', 'vasoactive-inotropic score index', 'incidence of unfavorable events', 'deep hypothermic circulatory arrest, selective antegrade cerebral perfusion', 'acute kidney injury incidence', 'Acute kidney injury', 'baseline characteristics and cardiopulmonary bypass duration', 'incidence of adverse events in the early postoperative period (acute kidney injury [KDIGO criteria], new brain MRI findings, and in-hospital mortality']","[{'cui': 'C0374711', 'cui_str': 'Surgical repair'}, {'cui': 'C0003492', 'cui_str': 'Coarctation of aorta'}, {'cui': 'C0265881', 'cui_str': 'Congenital hypoplasia of aortic arch'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C3164271', 'cui_str': 'Obstruction of aortic arch'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}]","[{'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C1564655', 'cui_str': 'Deep Hypothermic Circulatory Arrest'}, {'cui': 'C0589502', 'cui_str': 'Antegrade direction'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0003489', 'cui_str': 'Aortic arch structure'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0277608', 'cui_str': 'Death in hospital'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C4028269', 'cui_str': 'Nuclear magnetic resonance imaging brain'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1564655', 'cui_str': 'Deep Hypothermic Circulatory Arrest'}, {'cui': 'C0589502', 'cui_str': 'Antegrade direction'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}]",45.0,0.116031,Patients in the double arterial cannulation group had a significantly lower vasoactive-inotropic score index 24 hours postoperatively than the deep hypothermic circulatory arrest group (p=0.03).,"[{'ForeName': 'Y Y', 'Initials': 'YY', 'LastName': 'Kulyabin', 'Affiliation': 'Department of Pediatric Cardiac Surgery, Meshalkin National Medical Research Center, Novosibirsk, Russia. Electronic address: y.y.coolyabin@gmail.com.'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Bogachev-Prokophiev', 'Affiliation': 'Department of Heart Valve Disease, Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'I A', 'Initials': 'IA', 'LastName': 'Soynov', 'Affiliation': 'Department of Pediatric Cardiac Surgery, Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'A Y', 'Initials': 'AY', 'LastName': 'Omelchenko', 'Affiliation': 'Department of Pediatric Cardiac Surgery, Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Zubritskiy', 'Affiliation': 'Department of Pediatric Cardiac Surgery, Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'Y N', 'Initials': 'YN', 'LastName': 'Gorbatykh', 'Affiliation': 'Department of Pediatric Cardiac Surgery, Meshalkin National Medical Research Center, Novosibirsk, Russia.'}]",Seminars in thoracic and cardiovascular surgery,['10.1053/j.semtcvs.2020.04.015']
3115,32452814,The Personal Health Network Mobile App for Chemotherapy Care Coordination: Qualitative Evaluation of a Randomized Clinical Trial.,"BACKGROUND


Cancer care coordination addresses the fragmented and inefficient care of individuals with complex care needs. The complexity of care coordination can be aided by innovative technology. Few examples of information technology-enabled care coordination exist beyond the conventional telephone follow-up. For this study, we implemented a custom-designed app, the Personal Health Network (PHN)-a Health Insurance Portability and Accountability Act-compliant social network built around a patient to enable patient-centered health and health care activities in collaboration with clinicians, care team members, caregivers, and others designated by the patient. The app facilitates a care coordination intervention for patients undergoing chemotherapy.
OBJECTIVE


This study aimed to understand patient experiences with PHN technology and assess their perspectives on the usability and usefulness of PHNs with care coordination during chemotherapy.
METHODS


A two-arm randomized clinical trial was conducted to compare the PHN and care coordination with care coordination alone over a 6-month period beginning with the initiation of chemotherapy. A semistructured interview guide was constructed based on a theoretical framework of technology acceptance addressing usefulness, usability, and the context of use of the technology within the participant's life and health care setting. All participants in the intervention arm were interviewed on completion of the study. Interviews were recorded and transcribed verbatim. A summative thematic analysis was completed for the transcribed interviews. Features of the app were also evaluated.
RESULTS


A total of 27 interviews were completed. The resulting themes included the care coordinator as a partner in care, learning while sick, comparison of other technology to make sense of the PHN, communication, learning, usability, and usefulness. Users expressed that the nurse care coordinators were beneficial to them because they helped them stay connected to the care team and answered their questions. They shared that the mobile app gave them access to the health information they were seeking. Users expressed that the mobile app would be more useful if it was fully integrated with the electronic health record.
CONCLUSIONS


The findings highlight the value of care coordination from the perspectives of cancer patients undergoing chemotherapy and the important role of technology, such as the PHN, in enhancing this process by facilitating better communication and access to information regarding their illness.",2020,"A semistructured interview guide was constructed based on a theoretical framework of technology acceptance addressing usefulness, usability, and the context of use of the technology within the participant's life and health care setting.","['cancer patients undergoing', 'patients undergoing chemotherapy']","['chemotherapy', 'care coordination intervention']",[],"[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],27.0,0.0497466,"A semistructured interview guide was constructed based on a theoretical framework of technology acceptance addressing usefulness, usability, and the context of use of the technology within the participant's life and health care setting.","[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Ngo', 'Affiliation': 'Betty Irene Moore School of Nursing, University of California, Davis, Sacramento, CA, United States.'}, {'ForeName': 'Cynthia G', 'Initials': 'CG', 'LastName': 'Matsumoto', 'Affiliation': 'Betty Irene Moore School of Nursing, University of California, Davis, Sacramento, CA, United States.'}, {'ForeName': 'Jill G', 'Initials': 'JG', 'LastName': 'Joseph', 'Affiliation': 'Betty Irene Moore School of Nursing, University of California, Davis, Sacramento, CA, United States.'}, {'ForeName': 'Janice F', 'Initials': 'JF', 'LastName': 'Bell', 'Affiliation': 'Betty Irene Moore School of Nursing, University of California, Davis, Sacramento, CA, United States.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Bold', 'Affiliation': 'Comprehensive Cancer Center, University of California Davis Health, Sacramento, CA, United States.'}, {'ForeName': 'Andra', 'Initials': 'A', 'LastName': 'Davis', 'Affiliation': 'Washington State University College of Nursing - Vancouver, Vancouver, WA, United States.'}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Reed', 'Affiliation': 'Division of Social Work, California State University Sacramento, Sacramento, CA, United States.'}, {'ForeName': 'Katherine K', 'Initials': 'KK', 'LastName': 'Kim', 'Affiliation': 'Betty Irene Moore School of Nursing, University of California, Davis, Sacramento, CA, United States.'}]",JMIR mHealth and uHealth,['10.2196/16527']
3116,32452817,A Questionnaire for Assessing User Satisfaction With Mobile Health Apps: Development Using Rasch Measurement Theory.,"BACKGROUND


Mobile health (mHealth) apps offer great opportunities to deliver large-scale, cost-efficient digital solutions for implementing lifestyle changes. Furthermore, many mHealth apps act as medical devices. Yet, there is little research on how to assess user satisfaction with an mHealth solution.
OBJECTIVE


This study presents the development of the mHealth Satisfaction Questionnaire and evaluates its measurement properties.
METHODS


Respondents who took part in the Health Integrator Study and were randomized to use the Health Integrator smartphone app for lifestyle changes (n=112), with and without additional telephone coaching, rated their satisfaction with the app using the new 14-item mHealth Satisfaction Questionnaire. The ratings were given on a 5-point Likert scale and measurement properties were evaluated using Rasch measurement theory (RMT).
RESULTS


Optimal scoring was reached when response options 2, 3, and 4 were collapsed, giving three response categories. After omitting two items that did not fit into the scale, fit residuals were within, or close to, the recommended range of ±2.5. There was no differential item functioning between intervention group, age group, or sex. The Person Separation Index was 0.79, indicating that the scale's ability to discriminate correctly between person leniency was acceptable for group comparisons but not for individual evaluations. The scale did not meet the criterion of unidimensionality; 16.1% (18/112) of the respondents were outside the desired range of -1.96 to 1.96. In addition, several items showed local dependency and three underlying dimensions emerged: negative experiences, positive experiences, and lifestyle consequences of using the mHealth solution.
CONCLUSIONS


In times where mHealth apps and digital solutions are given more attention, the mHealth Satisfaction Questionnaire provides a new possibility to measure user satisfaction to ensure usability and improve development of new apps. Our study is one of only a few cases where RMT has been used to evaluate the usability of such an instrument. There is, though, a need for further development of the mHealth Satisfaction Questionnaire, including the addition of more items and consideration of further response options. The mHealth Satisfaction Questionnaire should also be evaluated in a larger sample and with other mHealth apps and in other contexts.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03579342; http://clinicaltrials.gov/ct2/show/NCT03579342.",2020,The scale did not meet the criterion of unidimensionality; 16.1% (18/112) of the respondents were outside the desired range of -1.96 to 1.96.,"['Respondents who took part in the Health Integrator Study', 'Mobile Health Apps']","['Health Integrator smartphone app for lifestyle changes (n=112), with and without additional telephone coaching']",['Person Separation Index'],"[{'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036679', 'cui_str': 'Separation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0311165,The scale did not meet the criterion of unidimensionality; 16.1% (18/112) of the respondents were outside the desired range of -1.96 to 1.96.,"[{'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Melin', 'Affiliation': 'Research Institutes of Sweden AB, Göteborg, Sweden.'}, {'ForeName': 'Stephanie Erika', 'Initials': 'SE', 'LastName': 'Bonn', 'Affiliation': 'Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Pendrill', 'Affiliation': 'Research Institutes of Sweden AB, Göteborg, Sweden.'}, {'ForeName': 'Ylva', 'Initials': 'Y', 'LastName': 'Trolle Lagerros', 'Affiliation': 'Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.'}]",JMIR mHealth and uHealth,['10.2196/15909']
3117,32452818,Assessment of the Efficacy of a Mobile Phone-Delivered Just-in-Time Planning Intervention to Reduce Alcohol Use in Adolescents: Randomized Controlled Crossover Trial.,"BACKGROUND


Interventions to reduce alcohol use typically include several elements, such as information on the risks of alcohol consumption, planning for sensible drinking, and training of protective behavioral strategies. However, the effectiveness of these individual intervention elements within comprehensive programs has not been addressed so far, but it could provide valuable insights for the development of future interventions. Just-in-time interventions provided via mobile devices are intended to help people make healthy decisions in the moment and thus could influence health behavior.
OBJECTIVE


The aim of this study was to test the proximal effects of a mobile phone-delivered, just-in-time planning intervention to reduce alcohol use in adolescents who reported recent binge drinking. The efficacy of this individual intervention element was tested within a comprehensive intervention program to reduce problem drinking in adolescents.
METHODS


The study had an AB/BA crossover design, in which participants were randomly allocated to (1) a group receiving the planning intervention (A) in period 1 and assessment only (B) in period 2 or (2) a group receiving assessment only (B) in period 1 and the planning intervention (A) in period 2. The planning intervention included a text message to choose one of two predetermined if-then plans to practice sensible drinking with friends or when going out and a prompt to visualize the chosen plan. There was a washout period of at least 1 week between period 1 and period 2.
RESULTS


Out of 633 program participants who recently binge drank, 136 (21.5%) were receptive in both periods of time and provided data on the proximal outcome, which was the number of alcoholic drinks consumed with friends or when going out. After the planning intervention, the number of alcoholic drinks consumed was approximately one standard drink lower compared with the finding without the intervention (P=.01).
CONCLUSIONS


A mobile phone-delivered, just-in-time, if-then planning intervention to practice sensible drinking with friends or when going out is effective in reducing alcohol consumption among adolescents who report recent binge drinking. Based on the relatively low percentage of participants with self-reported receptivity for the planning intervention, measures to increase the population impact of similar planning interventions should be implemented and tested in future trials.
TRIAL REGISTRATION


ISRCTN Registry ISRCTN52150713; http://www.isrctn.com/ISRCTN52150713.",2020,The planning intervention included a text message to choose one of two predetermined if-then plans to practice sensible drinking with friends or when going out and a prompt to visualize the chosen plan.,"['Adolescents', 'Out of 633 program participants who recently binge drank, 136 (21.5', 'adolescents who report recent binge drinking', 'adolescents who reported recent binge drinking', 'adolescents']","['mobile phone-delivered, just-in-time planning intervention', 'Mobile Phone-Delivered Just-in-Time Planning Intervention', 'planning intervention (A) in period 1 and assessment only (B) in period 2 or (2) a group receiving assessment only (B) in period 1 and the planning intervention']",['number of alcoholic drinks'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}]",633.0,0.048824,The planning intervention included a text message to choose one of two predetermined if-then plans to practice sensible drinking with friends or when going out and a prompt to visualize the chosen plan.,"[{'ForeName': 'Severin', 'Initials': 'S', 'LastName': 'Haug', 'Affiliation': 'Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Paz Castro', 'Affiliation': 'Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Urte', 'Initials': 'U', 'LastName': 'Scholz', 'Affiliation': 'Applied Social and Health Psychology, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Kowatsch', 'Affiliation': 'Center for Digital Health Interventions, Institute of Technology Management, University of St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Michael Patrick', 'Initials': 'MP', 'LastName': 'Schaub', 'Affiliation': 'Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Theda', 'Initials': 'T', 'LastName': 'Radtke', 'Affiliation': 'Health, Work & Organizational Psychology, School of Psychology and Psychotherapy, Witten/Herdecke University, Witten/Herdecke, Germany.'}]",JMIR mHealth and uHealth,['10.2196/16937']
3118,32450215,Ergonomical Assessment of Three-Dimensional Versus Two-Dimensional Thoracoscopic Lobectomy.,"In this study. we compared ergonomical domains characteristics of three-dimensional (3D) versus two-dimensional (2D) video-systems in thoracoscopic lobectomy using a scoring-scale-based assessment. Seventy patients (mean age, 69 ± 6.9 years, 43 males and 27 females) with early stage lung cancer were randomized to undergo thoracoscopic lobectomy by either 3D (N = 35) or 2D (N = 35) video-systems. All operations were divided into 5 standardized surgical steps (vein, artery, bronchus, fissure, and lymph nodes), which were evaluated by 4 thoracic surgeons using a scoring scale (score range from 1, unsatisfactory to 3,excellent) entailing assessment of 3 ergonomical domains: exposure, instrumentation and maneuvering. Primary outcome was a difference ≥10% in the maneuvering domain steps. At intergroup comparisons, there was no difference in demographics. The 3D system results were better for maneuvering domain total score and particularly for the artery and bronchus steps scores (score ≥10%, P ≤ 0.006). Other significant differences included exposure of the vein, artery and bronchus (P ≤ 0.03). Results favoring the 2D system included maneuvering, exposure and instrumentation of the fissure (P = 0.001). Inter-rater concordance of ergonomics scoring was satisfactory (Cronbach's α range, 0.85-0.88). Operative time was significantly shorter in the 3D group (127 ± 19 min vs 143±18 min, P = 0.001) whereas there was no difference in hospital stay (3.4 ± 1.2 vs 4.1 ± 1.6 days, P = 0.07). In this study comparison of ergonomic domains scoring in 3D versus 2D thoracoscopic lobectomy favored the 3D system for the maneuvering total score, which proved inversely correlated with operative times possibly due to a better perception of depth and more precise surgical maneuvering.",2020,"The 3D system results were better for maneuvering domain total score and particularly for the artery and bronchus steps scores (score≥10%, p≤0.006).","['Seventy patients (mean age, 69±6.9 years, 43 males and 27 females) with early stage lung cancer']","['three dimensional (3D) versus two dimensional (2D) video-systems in thoracoscopic lobectomy', 'thoracoscopic lobectomy by either 3D (N=35) or 2D (N=35) video-systems', 'ergonomic domains scoring in 3D vs 2D thoracoscopic lobectomy', 'dimensional thoracoscopic lobectomy']","['maneuvering domain steps', 'Operative time', 'maneuvering, exposure and instrumentation of the fissure', 'exposure of the vein, artery and bronchus (p≤0.03', 'hospital stay']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}]","[{'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0086246', 'cui_str': 'Human Engineering'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0332469', 'cui_str': 'Fissure'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0006255', 'cui_str': 'Bronchial structure'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",70.0,0.0379695,"The 3D system results were better for maneuvering domain total score and particularly for the artery and bronchus steps scores (score≥10%, p≤0.006).","[{'ForeName': 'Ahmed G', 'Initials': 'AG', 'LastName': 'Elkhouly', 'Affiliation': 'Department of Cardiothoracic Surgery, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Sorge', 'Affiliation': 'Department of Biostatistics, Policlinico Tor Vergata University, Rome, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Rogliani', 'Affiliation': 'Department of Respiratory Medicine, Policlinico Tor Vergata University, Rome, Italy.'}, {'ForeName': 'Benedetto', 'Initials': 'B', 'LastName': 'Cristino', 'Affiliation': 'Department of Thoracic Surgery, Policlinico Tor Vergata University, Rome, Italy.'}, {'ForeName': 'Ehab', 'Initials': 'E', 'LastName': 'Wahby', 'Affiliation': 'Department of Cardiothoracic Surgery, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Amro', 'Initials': 'A', 'LastName': 'Serag', 'Affiliation': 'Department of Cardiothoracic Surgery, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Hengrui', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': 'Department of Thoracic Surgery and Oncology, the First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, Guangzhou, China.'}, {'ForeName': 'Jianxing', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Thoracic Surgery and Oncology, the First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, Guangzhou, China.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Pompeo', 'Affiliation': 'Department of Thoracic Surgery, Policlinico Tor Vergata University, Rome, Italy. Electronic address: pompeo@med.uniroma2.it.'}]",Seminars in thoracic and cardiovascular surgery,['10.1053/j.semtcvs.2020.05.018']
3119,32450908,Efficacy and safety of Bujing Yishi tablet for glaucoma with controlled IOP: study protocol for a multi-centre randomized controlled trial.,"BACKGROUND


As an irreversible, intractable disease with vision loss, glaucoma leads to permanent and progressive damage of visual function. Lowering high intraocular pressure (HIOP) is the first choice for treating glaucoma; however, the control of HIOP is not enough to prevent progressive vison loss. Currently, the therapies to treat glaucoma with controlled IOP (GPCI) are unsatisfactory. Chinese medicine is effective for improving visual function in patients with GPCI. Bujing Yishi tablets (BJYSP) have been the standard preparation for treating GPCI in our hospital for decades. However, no rigorous randomized controlled clinical studies have investigated its effects and safety.
METHODS


This study will be a 6-month, multicenter, stratified trial following a prospective, randomized, open-label, blinded endpoint (PROBE) protocol. A total of 216 eligible GPCI patients aged 18-75 years will be stratified according to the early, moderate, and advanced stages of glaucoma. After stratifying, the participants will be randomly assigned to the BJYSP group or control group at a ratio of 1:1. Following randomization, participants in the BJYSP group and control group will receive BJYSP and mecobalamin tablets, respectively, for the same 6-month period. The primary outcomes will include the best-corrected visual acuity (BCVA), visual field assessment, visual evoked potential (VEP) test, and Heidelberg retina tomography II (HRT II); the secondary outcomes will include intraocular pressure (IOP) and Traditional Chinese medicine (TCM) clinical symptom scales. The primary and secondary outcomes will be measured at baseline and 8, 16, and 24 weeks thereafter. Safety assessments will also be evaluated at baseline and 12 and 24 weeks thereafter.
DISCUSSION


This study will be a standardized, scientific, clinical trial designed to evaluate the therapeutic effects and safety of BJYSP as a novel therapeutic strategy for improving visual function in patients with GPCI.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR1800016431. Registered on 1 June 2018.",2020,"The primary outcomes will include the best-corrected visual acuity (BCVA), visual field assessment, visual evoked potential (VEP) test, and Heidelberg retina tomography II (HRT II); the secondary outcomes will include intraocular pressure (IOP) and Traditional Chinese medicine (TCM) clinical symptom scales.","['patients with GPCI', '216 eligible GPCI patients aged 18-75\u2009years will be stratified according to the early, moderate, and advanced stages of glaucoma']","['BJYSP', 'Lowering high intraocular pressure (HIOP', 'Bujing Yishi tablets (BJYSP', 'BJYSP and mecobalamin tablets', 'Bujing Yishi tablet', 'Chinese medicine']","['visual function', 'best-corrected visual acuity (BCVA), visual field assessment, visual evoked potential (VEP) test, and Heidelberg retina tomography II (HRT II); the secondary outcomes will include intraocular pressure (IOP) and Traditional Chinese medicine (TCM) clinical symptom scales', 'Efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}]","[{'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0234708', 'cui_str': 'Raised intraocular pressure'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0065844', 'cui_str': 'mecobalamin'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015217', 'cui_str': 'Visual evoked potential'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",216.0,0.291797,"The primary outcomes will include the best-corrected visual acuity (BCVA), visual field assessment, visual evoked potential (VEP) test, and Heidelberg retina tomography II (HRT II); the secondary outcomes will include intraocular pressure (IOP) and Traditional Chinese medicine (TCM) clinical symptom scales.","[{'ForeName': 'Hongji', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'College of Ophthalmology, Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, Sichuan, China. carol_hongji@126.com.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Ophthalmology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, Sichuan, China. jeannelxiang@cdutcm.edu.cn.'}, {'ForeName': 'Zongduan', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, The Affiliated Eye Hospital of Wenzhou Medical University, Wenzhou, 325027, Zhejiang, China.'}, {'ForeName': 'Jieping', 'Initials': 'J', 'LastName': 'Zeng', 'Affiliation': 'National Drug Clinical Trial Agency, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, Sichuan, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Dai', 'Affiliation': 'Department of Ophthalmology, Mianyang Central Hospital, Mianyang, 621000, Sichuan, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, Mianyang Hospital of Traditional Chinese Medicine, Mianyang, 621000, Sichuan, China.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': ""Department of Ophthalmology, The Second People's Hospital of Chengdu PiDu District, Chengdu, 611733, Sichuan, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Cheng', 'Affiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, 510275, Guang-dong, China.'}, {'ForeName': 'Linru', 'Initials': 'L', 'LastName': 'Cui', 'Affiliation': 'College of Ophthalmology, Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, Sichuan, China.'}]",Trials,['10.1186/s13063-020-04249-7']
3120,32459117,Effects of rosuvastatin and zoledronic acid in combination on the recovery of senile osteoporotic vertebral compression fracture following percutaneous vertebroplasty.,"OBJECTIVES


This study analyzed the effects of rosuvastatin and zoledronic acid in combination on patient recovery following percutaneous vertebroplasty (PVP) that was performed to treat senile osteoporotic vertebral compression.
METHODS


Senile patients with osteoporotic vertebral compression fracture (n = 120) were included in this retrospective study, and they were classified into two groups. Those in the control group (n = 60) were treated with PVP + caltrate and those in the observation group (n = 60) received this treatment with combined zoledronic acid and rosuvastatin. Between-group comparisons were made at both pre- and post-treatment regarding bone density, type I procollagen peptide (CTX) and bone-specific alkaline phosphatase (BAP) levels, visual analog scale (VAS) score, Oswestry Disability Index (ODI) score, and adjacent centrum refracture.
RESULTS


Bone density was higher and BAP and CTX levels as well as ODI and VAS scores were lower at post-treatment in the observation group compared with the control group. The refracture rate in the observation group was lower compared with the control group.
CONCLUSION


Treatment with a combination of rosuvastatin and zoledronic acid following PVP can improve the condition of senile osteoporotic vertebral compression fracture and patient's functional status, and it can also alleviate pain.",2020,"RESULTS


Bone density was higher and BAP and CTX levels as well as ODI and VAS scores were lower at post-treatment in the observation group compared with the control group.","['Senile patients with osteoporotic vertebral compression fracture (n\u2009=\u2009120', 'senile osteoporotic vertebral compression fracture following percutaneous vertebroplasty']","['percutaneous vertebroplasty (PVP', 'combined zoledronic acid and rosuvastatin', 'rosuvastatin and zoledronic acid following PVP', 'rosuvastatin and zoledronic acid', 'PVP\u2009+\u2009caltrate']","['BAP and CTX levels', 'bone density, type I procollagen peptide (CTX) and bone-specific alkaline phosphatase (BAP) levels, visual analog scale (VAS) score, Oswestry Disability Index (ODI) score, and adjacent centrum refracture', 'refracture rate', 'ODI and VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262431', 'cui_str': 'Compression fracture of vertebral column'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C1303192', 'cui_str': 'Vertebroplasty'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C1303192', 'cui_str': 'Vertebroplasty'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0719118', 'cui_str': 'Caltrate'}]","[{'cui': 'C0047830', 'cui_str': ""4,4'-thiodianiline""}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0041457', 'cui_str': 'Type I Procollagen'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0312399', 'cui_str': 'Alkaline phosphatase isoenzyme, bone fraction'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C2960603', 'cui_str': 'Oswestry disability index score'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",120.0,0.0210401,"RESULTS


Bone density was higher and BAP and CTX levels as well as ODI and VAS scores were lower at post-treatment in the observation group compared with the control group.","[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Yue', 'Affiliation': 'Department of Orthopedics, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Shunlun', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopedics, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Chunde', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Peking University First Hospital, Beijing, China.'}]",The Journal of international medical research,['10.1177/0300060520925390']
3121,32454209,"Psilocybin acutely alters the functional connectivity of the claustrum with brain networks that support perception, memory, and attention.","Psychedelic drugs, including the serotonin 2a (5-HT 2A ) receptor partial agonist psilocybin, are receiving renewed attention for their possible efficacy in treating a variety of neuropsychiatric disorders. Psilocybin induces widespread dysregulation of cortical activity, but circuit-level mechanisms underlying this effect are unclear. The claustrum is a subcortical nucleus that highly expresses 5-HT 2A  receptors and provides glutamatergic inputs to arguably all areas of the cerebral cortex. We therefore tested the hypothesis that psilocybin modulates claustrum function in humans. Fifteen healthy participants (10M, 5F) completed this within-subjects study in which whole-brain resting-state blood-oxygenation level-dependent (BOLD) signal was measured 100 ​min after blinded oral administration of placebo and 10 mg/70 ​kg psilocybin. Left and right claustrum signal was isolated using small region confound correction. Psilocybin significantly decreased both the amplitude of low frequency fluctuations as well as the variance of BOLD signal in the left and right claustrum. Psilocybin also significantly decreased functional connectivity of the right claustrum with auditory and default mode networks (DMN), increased right claustrum connectivity with the fronto-parietal task control network (FPTC), and decreased left claustrum connectivity with the FPTC. DMN integrity was associated with right-claustrum connectivity with the DMN, while FPTC integrity and modularity were associated with right claustrum and left claustrum connectivity with the FPTC, respectively. Subjective effects of psilocybin predicted changes in the amplitude of low frequency fluctuations and the variance of BOLD signal in the left and right claustrum. Observed effects were specific to claustrum, compared to flanking regions of interest (the left and right insula and putamen). This study used a pharmacological intervention to provide the first empirical evidence in any species for a significant role of 5-HT 2A  receptor signaling in claustrum functioning, and supports a possible role of the claustrum in the subjective and therapeutic effects of psilocybin.",2020,Psilocybin significantly decreased both the amplitude of low frequency fluctuations as well as the variance of BOLD signal in the left and right claustrum.,"['Fifteen healthy participants (10M, 5F) completed this within-subjects study in which whole-brain resting-state blood-oxygenation level-dependent (BOLD) signal was measured 100\u202fmin after blinded oral administration of', 'humans']","['psilocybin', 'placebo and 10 mg/70\u202fkg psilocybin', 'Psilocybin', 'serotonin 2a (5-HT 2A ) receptor partial agonist psilocybin']","['BOLD signal', 'amplitude of low frequency fluctuations', 'functional connectivity of the right claustrum with auditory and default mode networks (DMN), increased right claustrum connectivity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0001563', 'cui_str': 'Medication administration: oral'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0033850', 'cui_str': 'Psilocybine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0008910', 'cui_str': 'Claustral structure'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",15.0,0.0313229,Psilocybin significantly decreased both the amplitude of low frequency fluctuations as well as the variance of BOLD signal in the left and right claustrum.,"[{'ForeName': 'Frederick S', 'Initials': 'FS', 'LastName': 'Barrett', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, 21224, USA; Center for Psychedelic and Consciousness Research, Johns Hopkins University School of Medicine, Baltimore, MD, 21224, USA. Electronic address: fbarrett@jhmi.edu.'}, {'ForeName': 'Samuel R', 'Initials': 'SR', 'LastName': 'Krimmel', 'Affiliation': 'Department of Neural and Pain Sciences, School of Dentistry, and Center to Advance Chronic Pain Research, University of Maryland, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Roland R', 'Initials': 'RR', 'LastName': 'Griffiths', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, 21224, USA; Center for Psychedelic and Consciousness Research, Johns Hopkins University School of Medicine, Baltimore, MD, 21224, USA; Department of Neuroscience, Johns Hopkins University School of Medicine, Baltimore, MD, 21224, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Seminowicz', 'Affiliation': 'Department of Neural and Pain Sciences, School of Dentistry, and Center to Advance Chronic Pain Research, University of Maryland, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Brian N', 'Initials': 'BN', 'LastName': 'Mathur', 'Affiliation': 'Department of Pharmacology, School of Medicine, University of Maryland, Baltimore, MD, 21201, USA.'}]",NeuroImage,['10.1016/j.neuroimage.2020.116980']
3122,32454317,Web-based experiential learning strategies to enhance the evidence-based-practice competence of undergraduate nursing students.,"BACKGROUND


Evidence-based practice (EBP) is considered a key competence for practicing high-quality and safe nursing. However, undergraduate nursing programs continue to provide traditional classroom teaching strategies that have limitations in facilitating the development of critical competences for engaging in EBP in real clinical contexts.
OBJECTIVE AND DESIGN


The purpose of this study was to develop a web-based experiential learning program aimed at improving the engagement and experience of nursing students in EBP. A quasi-experimental research with non-equivalent control-group with non-synchronized design was used to describe the process of program development and the innovative learning method, and discuss the outcomes of the program.
METHODS


The experimental group was exposed to a web-based experiential learning program, while the control group received traditional learning with written material. Self-reported EBP scores (knowledge and skills, attitude, and practice) and clinical-questioning confidence were evaluated to assess the effects of the program.
RESULTS


The result showed that web-based experiential learning strategies were effective in significantly improving the EBP knowledge and skills score (F = 12.29, p = .001) and the score for confidence in asking clinical questions (F = 12.14, p = .001). The attitudes toward EBP (F = 0.75, p = .389) and practice score (F = 3.22, p = .076) did not show a significant difference between the experimental group and the control group.
CONCLUSION


The web-based experiential learning was found to be an effective method for enhancing the EBP competence of nursing students. Based on the study results, we suggest using web-based experiential learning to supplement the traditional learning method or as the mainstream learning method for nursing students.",2020,The web-based experiential learning was found to be an effective method for enhancing the EBP competence of nursing students.,"['undergraduate nursing students', 'nursing students in EBP']","['web-based experiential learning program, while the control group received traditional learning with written material']","['Self-reported EBP scores (knowledge and skills, attitude, and practice) and clinical-questioning confidence', 'practice score', 'EBP knowledge and skills score']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C1510541', 'cui_str': 'Evidence-Based Practice'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0243012', 'cui_str': 'Active Learning'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1510541', 'cui_str': 'Evidence-Based Practice'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",,0.0182641,The web-based experiential learning was found to be an effective method for enhancing the EBP competence of nursing students.,"[{'ForeName': 'Myonghwa', 'Initials': 'M', 'LastName': 'Park', 'Affiliation': 'College of Nursing, Chungnam National University, Republic of Korea.'}, {'ForeName': 'Miri', 'Initials': 'M', 'LastName': 'Jeong', 'Affiliation': 'College of Nursing, Chungnam National University, Republic of Korea. Electronic address: miri9912@naver.com.'}, {'ForeName': 'Mihyun', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'College of Nursing, Daejeon Health Institute of Technology, Republic of Korea.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cullen', 'Affiliation': 'Department of Nursing Services and Patient Care, University of Iowa Hospitals and Clinics, United States of America.'}]",Nurse education today,['10.1016/j.nedt.2020.104466']
3123,32455817,"Actaea racemosa  L. Is More Effective in Combination with  Rhodiola rosea  L. for Relief of Menopausal Symptoms: A Randomized, Double-Blind, Placebo-Controlled Study.","Background : The aim of this study was to assess the efficacy and safety of a new herbal preparation (Menopause Relief EP ® ), the hybrid combination of  Actaea racemosa  L. (black cohosh, BC) and  Rhodiola rosea  L. (RR) root extracts, compared with the most effective dose of BC extract in women with menopausal complaints.  Methods:  A total of 220 women were randomly assigned to receive two capsules either BC (6.5 mg), BC500 (500 mg), Menopause Relief EP ®  (206,5), or placebo once per day for 12 weeks. The efficacy endpoints were relief of menopausal symptoms, measured using the Kupperman Menopausal Index (KMI), Menopause Relief Score (MRS), and menopause Utian Quality of Life (UQOL) index.  Results:  The menopause symptom relief effects of RR-BC were significantly superior in all tests to the effects of BC and placebo after their repeated administration for 6 and 12 weeks. There was no statistically significant difference between the effects of BC and BC500 over time. RR-BC significantly improved the QOL index in patients, compared to BC, BC500, and placebo, mainly due to the beneficial effects on the emotional and health domains.  Conclusions:  BC is more effective in combination with RR in relief of menopausal symptoms, particularly psychological symptoms.",2020,The menopause symptom relief effects of RR-BC were significantly superior in all tests to the effects of BC and placebo after their repeated administration for 6 and 12 weeks.,"['A total of 220 women', 'women with menopausal complaints', 'Menopausal Symptoms']","['Placebo', 'BC extract', 'new herbal preparation (Menopause Relief EP ® ', 'BC', 'BC500 (500 mg), Menopause Relief EP ®  (206,5), or placebo', 'placebo']","['efficacy and safety', 'relief of menopausal symptoms, measured using the Kupperman Menopausal Index (KMI), Menopause Relief Score (MRS), and menopause Utian Quality of Life (UQOL) index', 'QOL index']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0949854', 'cui_str': 'Plant Preparation'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C3816747', 'cui_str': '500'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",220.0,0.473585,The menopause symptom relief effects of RR-BC were significantly superior in all tests to the effects of BC and placebo after their repeated administration for 6 and 12 weeks.,"[{'ForeName': 'Lali', 'Initials': 'L', 'LastName': 'Pkhaladze', 'Affiliation': 'I.Zhordania Institute of Reproductology, 13, Tevdore Mghvdeli street, Tbilisi 0112, Georgia.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Davidova', 'Affiliation': 'I.Zhordania Institute of Reproductology, 13, Tevdore Mghvdeli street, Tbilisi 0112, Georgia.'}, {'ForeName': 'Archil', 'Initials': 'A', 'LastName': 'Khomasuridze', 'Affiliation': 'I.Zhordania Institute of Reproductology, 13, Tevdore Mghvdeli street, Tbilisi 0112, Georgia.'}, {'ForeName': 'Ramaz', 'Initials': 'R', 'LastName': 'Shengelia', 'Affiliation': 'Department for History of Medicine and Bioethics, Tbilisi State Medical University, Vazha-Pshavela avenue 33, Tbilisi 0162, Georgia.'}, {'ForeName': 'Alexander G', 'Initials': 'AG', 'LastName': 'Panossian', 'Affiliation': 'Phytomed AB, Bofinkvagen 1, 31275 Vaxtorp, Sweden.'}]","Pharmaceuticals (Basel, Switzerland)",['10.3390/ph13050102']
3124,32455843,Short-Term Effects of Comprehensive Pulmonary Rehabilitation and its Maintenance in Patients with Idiopathic Pulmonary Fibrosis: A Randomized Controlled Trial.,"The recommendation for pulmonary rehabilitation (PR) in idiopathic pulmonary fibrosis (IPF) is weak with low-quality evidence. Therefore, the aim of this study is to investigate short-term PR effects and their maintenance after a 3-month follow-up. Fifty-four IPF patients were randomized into a group receiving a 3-week comprehensive, inpatient PR ( n  = 34, FVC: 74 ± 19% pred.) or usual care (UC) ( n  = 17, FVC: 72 ± 20%pred.). Outcomes were measured at baseline (T1), after intervention (T2), and 3 months after T2 (T3). A 6-min walk distance (6MWD) was used as the primary outcome and chronic respiratory disease questionnaire (CRQ) scores as the secondary outcome. Change in 6MWD from T1 to T2 (Δ = 61 m, 95% CI (18.5-102.4),  p  = 0.006) but not from T1 to T3 (∆ = 26 m, 95% CI (8.0-61.5),  p  = 0.16) differed significantly between groups. Higher baseline FVC and higher anxiety symptoms were significant predictors of better short-term 6MWD improvements. For the change in CRQ total score, a significant between-group difference from T1 to T2 (∆ = 3.0 pts, 95% CI (0.7-5.3),  p  = 0.01) and from T1 to T3 (∆ = 3.5 pts, 95% CI (1.5-5.4),  p  = 0.001) was found in favour of the PR group. To conclude, in addition to the short-term benefits, inpatient PR is effective at inducing medium-term quality of life improvements in IPF. PR in the early stages of the disease seems to provoke the best benefits.",2020,"(Δ = 61 m, 95% CI (18.5-102.4),  p  = 0.006) but not from T1 to T3 (∆ = 26 m, 95% CI (8.0-61.5),  p  = 0.16) differed significantly between groups.","['idiopathic pulmonary fibrosis (IPF', 'Fifty-four IPF patients', 'Patients with Idiopathic Pulmonary Fibrosis']","['Comprehensive Pulmonary Rehabilitation', 'usual care (UC', 'pulmonary rehabilitation (PR']","['anxiety symptoms', 'CRQ total score', 'A 6-min walk distance (6MWD', 'chronic respiratory disease questionnaire (CRQ) scores']","[{'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C3164099', 'cui_str': 'Chronic respiratory disease questionnaire score'}]",54.0,0.058295,"(Δ = 61 m, 95% CI (18.5-102.4),  p  = 0.006) but not from T1 to T3 (∆ = 26 m, 95% CI (8.0-61.5),  p  = 0.16) differed significantly between groups.","[{'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Jarosch', 'Affiliation': 'Institute for Pulmonary Rehabilitation Research, Schoen Klinik Berchtesgadener Land, Malterhoeh 1, 83471 Schoenau am Koenigssee, Germany.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Schneeberger', 'Affiliation': 'Institute for Pulmonary Rehabilitation Research, Schoen Klinik Berchtesgadener Land, Malterhoeh 1, 83471 Schoenau am Koenigssee, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Gloeckl', 'Affiliation': 'Institute for Pulmonary Rehabilitation Research, Schoen Klinik Berchtesgadener Land, Malterhoeh 1, 83471 Schoenau am Koenigssee, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kreuter', 'Affiliation': 'Center for Interstitial and Rare Lung Diseases, Pneumology, Thoraxklinik University of Heidelberg, Germany and German Center for Lung Research, Röntgenstr. 1, 69126 Heidelberg, Germany.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Frankenberger', 'Affiliation': 'Comprehensive Pneumology Center (CPC), Ludwig-Maximilians University, Helmholtz Zentrum München, Member of the German Center for Lung Research (DZL), 81377 Munich, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Neurohr', 'Affiliation': 'Pneumology and Thoracic Oncology, Robert-Bosch Krankenhaus, Klinik Schillerhoehe, 70839 Gerlingen, Germany.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Prasse', 'Affiliation': 'Department of Respiratory Medicine, Hannover Medical School and Biomedical Research in End-Stage and Obstructive Lung Disease Hannover, German Lung Research Center (DZL), 30625 Hannover, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Freise', 'Affiliation': 'Department of Respiratory Medicine, Hannover Medical School and Biomedical Research in End-Stage and Obstructive Lung Disease Hannover, German Lung Research Center (DZL), 30625 Hannover, Germany.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Behr', 'Affiliation': 'Department of Internal Medicine V and Asklepios Fachkliniken München-Gauting, Comprehensive Pneumology Center (CPC-M), Member of the German Center for Lung Research, University of Munich, LMU, 82131 Munich, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Hitzl', 'Affiliation': 'Research Program Experimental Ophthalmology and Glaucoma Research, Paracelsus Medical University, 5020 Salzburg, Austria.'}, {'ForeName': 'Andreas R', 'Initials': 'AR', 'LastName': 'Koczulla', 'Affiliation': 'Institute for Pulmonary Rehabilitation Research, Schoen Klinik Berchtesgadener Land, Malterhoeh 1, 83471 Schoenau am Koenigssee, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Kenn', 'Affiliation': 'Institute for Pulmonary Rehabilitation Research, Schoen Klinik Berchtesgadener Land, Malterhoeh 1, 83471 Schoenau am Koenigssee, Germany.'}]",Journal of clinical medicine,['10.3390/jcm9051567']
3125,32455857,The Effects of Lateral Bounds on Post-Activation Potentiation of Change-of-Direction Speed Measured by the 505 Test in College-Aged Men and Women.,"Forty recreationally-trained individuals completed four testing sessions to determine whether lateral bounds (LB) or weighted lateral bounds enhanced change-of-direction (COD) speed measured by the 505 COD speed test. Session 1 included vertical jump and lateral bound (LB) testing to measure power. Sessions 2-4 involved three randomized conditioning activities (CA): 3 × 5 LB; 3 × 5 weighted LB (10% body mass provided by a weighted vest); and a control condition (4-min rest). The 505 COD speed test was performed 5- and 2.5-min pre-CA, and ~15 s, 4, 8, 12, and 16 min post-CA. A 3 × 6 repeated measures analysis of variance (ANOVA) calculated performance changes across time points post-CA. A 3 × 2 repeated measures ANOVA analyzed best potentiated performance. Smallest worthwhile change (SWC) measured within-subject 505 COD speed test performance. Partial correlations controlling for sex calculated relationships between the vertical jump, LB, and percent potentiation. There were no differences ( p  = 0.919) in 505 time relative to baseline for any CA, nor was the SWC exceeded. The best potentiated 505 time was faster ( p  < 0.001) than baseline for all CA, with no between-CA differences. There were no significant ( p  = 0.056-0.993) correlations between power and potentiation. LB and weighted LB did not potentiate the 505 COD speed test, although performance was not hindered.",2020,"There were no differences ( p  = 0.919) in 505 time relative to baseline for any CA, nor was the SWC exceeded.","['College-Aged Men and Women', 'Forty recreationally-trained individuals']",['lateral bounds (LB) or weighted lateral bounds enhanced change-of-direction (COD) speed measured by the 505 COD speed test'],"['vertical jump and lateral bound (LB) testing to measure power', 'Smallest worthwhile change (SWC']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449250', 'cui_str': 'Speed of test'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0225115,"There were no differences ( p  = 0.919) in 505 time relative to baseline for any CA, nor was the SWC exceeded.","[{'ForeName': 'Ashley J', 'Initials': 'AJ', 'LastName': 'Orjalo', 'Affiliation': 'Department of Kinesiology, California State University, Fullerton, CA 92831, USA.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Lockie', 'Affiliation': 'Department of Kinesiology, California State University, Fullerton, CA 92831, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Balfany', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Colorado, Anschutz Medical Campus, Aurora, CO 80045, USA.'}, {'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'Callaghan', 'Affiliation': 'Centre for Sports and Exercise Science Research, School of Medical and Health Sciences, Edith Cowan University, Joondalup, WA 6027, Australia.'}]","Sports (Basel, Switzerland)",['10.3390/sports8050071']
3126,32449697,The effects of empagliflozin vs metformin on endothelial microparticles in overweight/obese women with polycystic ovary syndrome.,"Context


Endothelial microparticles (EMPs) are novel, surrogate biomarkers of endothelial function and have been shown to be elevated in women with polycystic ovary syndrome (PCOS). It remains poorly understood how pharmacological options for managing PCOS affect EMP levels.
Objective


To characterise and compare the effects of empagliflozin vs metformin on the circulating levels of EMPs in overweight/obese women with PCOS.
Methods


This was a randomised, comparative, 12-week single-centre trial conducted at the Academic Diabetes, Endocrinology and Metabolism Research Centre, Hull, UK. This analysis includes data from 39 overweight/obese women with PCOS who completed the study and were randomised to empagliflozin (15 mg/day) (n = 19) or metformin (1500 mg/day) (n = 20). Blood samples were collected at baseline and 12 weeks after treatment and analysed for specific surface proteins (ICAM-1, VCAM-1, PECAM-1, E-selectin and endoglin) expressed by circulating EMPs using flow cytometry.
Results


In the empagliflozin group, ICAM-1 (P = 0.006), E-selectin (P = 0.016) and VCAM-1 (P = 0.001) EMPs increased significantly following 12 weeks of treatment, but no changes were seen in PECAM-1 (P = 0.93) or endoglin (P = 0.13) EMPs. In the metformin group, VCAM-1 EMPs (P < 0.001) increased significantly after 12 weeks of treatment, whereas all other EMPs remained unchanged. When data were expressed as percentage change from baseline in each group, no significant differences were seen between groups for any biomarker (P-values from 0.22 to 0.80).
Conclusions


Short-term administration of empagliflozin and metformin in overweight/obese women with PCOS appear to increase EMPs expressed by endothelial cells during their activation.",2020,"In the metformin group, VCAM-1 EMPs (p<0.001) increased significantly after 12 weeks of treatment, whereas all other EMPs remained unchanged.","['overweight/obese women with PCOS', 'women with polycystic ovary syndrome (PCOS', 'overweight/obese women with polycystic ovary syndrome', 'overweight/ obese women with PCOS', 'thirty-nine overweight/obese women with PCOS who completed the study']","['empagliflozin vs. metformin', 'empagliflozin and metformin', 'empagliflozin', 'metformin']","['circulating levels of EMPs', 'VCAM-1 EMPs', 'E-selectin', 'Blood samples', 'ICAM-1', 'VCAM-1 (p=0.001) EMPs', 'endothelial microparticles']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C2350307', 'cui_str': 'Microparticles, Cell-Derived'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0115305', 'cui_str': 'Lymphocyte antigen CD62E'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0063695', 'cui_str': 'Lymphocyte antigen CD54'}]",,0.10233,"In the metformin group, VCAM-1 EMPs (p<0.001) increased significantly after 12 weeks of treatment, whereas all other EMPs remained unchanged.","[{'ForeName': 'Zeeshan', 'Initials': 'Z', 'LastName': 'Javed', 'Affiliation': 'Department of Academic Diabetes, Endocrinology and Metabolism, Hull York Medical School, University of Hull, Hull, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Papageorgiou', 'Affiliation': 'Department of Academic Diabetes, Endocrinology and Metabolism, Hull York Medical School, University of Hull, Hull, UK.'}, {'ForeName': 'Leigh A', 'Initials': 'LA', 'LastName': 'Madden', 'Affiliation': 'School of Life Sciences, University of Hull, Hull, UK.'}, {'ForeName': 'Alan S', 'Initials': 'AS', 'LastName': 'Rigby', 'Affiliation': 'Hull York Medical School, University of Hull, Hull, UK.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Kilpatrick', 'Affiliation': 'Department of Pathology, Sidra Medical and Research Center, Doha, Qatar.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Atkin', 'Affiliation': 'Royal College of Surgeons in Ireland, Al Sayh, Bahrain.'}, {'ForeName': 'Thozhukat', 'Initials': 'T', 'LastName': 'Sathyapalan', 'Affiliation': 'Department of Academic Diabetes, Endocrinology and Metabolism, Hull York Medical School, University of Hull, Hull, UK.'}]",Endocrine connections,['10.1530/EC-20-0173']
3127,32449960,"Assessing consumers' understanding of the term ""Natural"" on food labeling.","The objective of this study was to gain a better understanding of how consumers' interpret the term ""natural"" by assessing food choice based on labels describing attributes of a product associated with the term ""natural""; to assess food intake of chosen food, and; to determine factors that influence food choice and intake. A randomized, single-visit pilot study was conducted where participants (n = 105) were presented with seven identical bowls of granola each bearing a different descriptive label. Participants were asked to choose and eat the granola (ad libitum) that coincided with what was closest to their view of ""natural."" Food choice, intake amount, demographics, self-health perception, label use, dietary restraint, and mindfulness were measured. ""Organic"" (31%), ""Made with real grains"" (17%), and ""No preservatives"" (15%) were the top three chosen labels. These choices related to concerns about environment and processing, personal health, and additives and preservatives, respectively (P = 0.049). Income level and age were significantly associated with choice (P = 0.003). Defining the term ""natural"" for use on food labels will require follow-up researchacrosseconomically diverse populations and age groups to understand expectations of food products bearing the term ""natural.""",2020,"These choices related to concerns about environment and processing, personal health, and additives and preservatives, respectively (P = 0.049).",['participants (n = 105) were presented with seven identical bowls of granola each bearing a different descriptive label'],[],"['Food choice, intake amount, demographics, self-health perception, label use, dietary restraint, and mindfulness']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0336949', 'cui_str': 'Bowling'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}]",[],"[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",105.0,0.0447794,"These choices related to concerns about environment and processing, personal health, and additives and preservatives, respectively (P = 0.049).","[{'ForeName': 'Sajida', 'Initials': 'S', 'LastName': 'Rahman', 'Affiliation': 'Department of Food Science and Nutrition, Center for Nutrition Research, Illinois Institute of Technology, Chicago, IL, 60616, USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Zasadzinski', 'Affiliation': 'Department of Food Science and Nutrition, Center for Nutrition Research, Illinois Institute of Technology, Chicago, IL, 60616, USA.'}, {'ForeName': 'Lanjun', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Department of Food Science and Nutrition, Center for Nutrition Research, Illinois Institute of Technology, Chicago, IL, 60616, USA.'}, {'ForeName': 'Indika', 'Initials': 'I', 'LastName': 'Edirisinghe', 'Affiliation': 'Department of Food Science and Nutrition, Center for Nutrition Research, Illinois Institute of Technology, Chicago, IL, 60616, USA.'}, {'ForeName': 'Britt', 'Initials': 'B', 'LastName': 'Burton-Freeman', 'Affiliation': 'Department of Food Science and Nutrition, Center for Nutrition Research, Illinois Institute of Technology, Chicago, IL, 60616, USA.'}]",Journal of food science,['10.1111/1750-3841.15128']
3128,32452527,Author response to: Comment on: Prevention of biliary fistula after partial hepatectomy by transcystic biliary drainage: randomized clinical trial.,,2020,,['biliary fistula after partial hepatectomy by transcystic biliary drainage'],[],[],"[{'cui': 'C0005417', 'cui_str': 'Fistula of bile duct'}, {'cui': 'C0193398', 'cui_str': 'Partial hepatectomy'}, {'cui': 'C0400745', 'cui_str': 'Biliary drainage'}]",[],[],,0.112895,,"[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Muscari', 'Affiliation': 'Department of Digestive Surgery and Liver Transplantation, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Maulat', 'Affiliation': 'Department of Digestive Surgery and Liver Transplantation, Toulouse University Hospital, Toulouse, France.'}]",The British journal of surgery,['10.1002/bjs.11699']
3129,32452528,Comment on: Prevention of biliary fistula after partial hepatectomy by transcystic biliary drainage: randomized clinical trial.,,2020,,['biliary fistula after partial hepatectomy by transcystic biliary drainage'],[],[],"[{'cui': 'C0005417', 'cui_str': 'Fistula of bile duct'}, {'cui': 'C0193398', 'cui_str': 'Partial hepatectomy'}, {'cui': 'C0400745', 'cui_str': 'Biliary drainage'}]",[],[],,0.146591,,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Akbulut', 'Affiliation': 'Department of Surgery and Liver Transplant Institute, Inonu University Faculty of Medicine, Malatya, Turkey.'}, {'ForeName': 'T T', 'Initials': 'TT', 'LastName': 'Sahin', 'Affiliation': 'Department of Surgery and Liver Transplant Institute, Inonu University Faculty of Medicine, Malatya, Turkey.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Surgery and Liver Transplant Institute, Inonu University Faculty of Medicine, Malatya, Turkey.'}]",The British journal of surgery,['10.1002/bjs.11700']
3130,32454161,Acute methylphenidate administration reduces cocaine-cue attentional bias.,"Mechanistic research on behavioral processes underlying substance use disorder might help identify novel targets for interventions development. Drug-related attentional bias and response inhibition deficits have received a great deal of consideration in substance use research, broadly, and cocaine use research, specifically. Studies investigating pharmacological mechanisms that may ameliorate, or further impair, these behaviors relevant to cocaine use are relatively lacking. This study evaluated the impact of acute administration of methylphenidate, a dopamine-favoring reuptake inhibitor, on both gaze-related cocaine-cue-attentional bias and cocaine-cue related disruptions in response inhibition among individuals with cocaine use disorder. Participants (N = 12; 33% female) completed a within-subject, outpatient, acute dosing study. Two sessions were completed in which methylphenidate (60 mg) or placebo were administered followed by completion of an attentional bias task using eye-tracking technology and neutral-cue and cocaine-cue response inhibition tasks. Subjective and physiological effects were also recorded. Significant cocaine cue attentional bias and response inhibition failures were observed during placebo administration. Acute methylphenidate administration reduced cocaine-cue attentional bias as measured by cocaine-cue gaze fixations (d z  = 1.04; Bayes Factor = 12.37). No statistically significant effects of methylphenidate were observed on response inhibition (Bayes Factors = 0.17-1.04). Methylphenidate produced prototypical subjective and physiological effects. Although the small sample should be considered, these findings indicate acute manipulation of dopaminergic activity reduced cue-related attentional allocation related to cocaine use disorder. Future research evaluating alternative dopaminergic agents and applications within a clinical setting are needed to determine the clinical significance of targeting this neurobehavioral mechanism.",2020,No statistically significant effects of methylphenidate were observed on response inhibition (Bayes Factors = 0.17-1.04).,"['individuals with cocaine use disorder', 'Participants (N\u202f=\u202f12; 33% female) completed a within-subject, outpatient, acute dosing study']","['cocaine-cue gaze fixations ', 'attentional bias task using eye-tracking technology and neutral-cue and cocaine-cue response inhibition tasks', 'methylphenidate', 'Methylphenidate', 'Acute methylphenidate', 'placebo']","['prototypical subjective and physiological effects', 'response inhibition', 'cocaine-cue attentional bias', 'Subjective and physiological effects', 'Significant cocaine cue attentional bias and response inhibition failures']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",2.0,0.0536529,No statistically significant effects of methylphenidate were observed on response inhibition (Bayes Factors = 0.17-1.04).,"[{'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Alcorn', 'Affiliation': 'Department of Behavioral Science, University of Kentucky College of Medicine, 1110 Veterans Drive, Medical Behavioral Science Building Room 140, Lexington, KY 40536-0086, USA.'}, {'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'Strickland', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD 21224, USA.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Lile', 'Affiliation': 'Department of Behavioral Science, University of Kentucky College of Medicine, 1110 Veterans Drive, Medical Behavioral Science Building Room 140, Lexington, KY 40536-0086, USA; Department of Psychology, University of Kentucky College of Arts and Sciences, 110 Kastle Hall, Lexington, KY 40506-0044, USA; Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY 40509-1810, USA.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Stoops', 'Affiliation': 'Department of Behavioral Science, University of Kentucky College of Medicine, 1110 Veterans Drive, Medical Behavioral Science Building Room 140, Lexington, KY 40536-0086, USA; Department of Psychology, University of Kentucky College of Arts and Sciences, 110 Kastle Hall, Lexington, KY 40506-0044, USA; Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY 40509-1810, USA; Center on Drug and Alcohol Research, University of Kentucky College of Medicine, 845 Angliana Ave, Lexington, KY 40508, USA.'}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Rush', 'Affiliation': 'Department of Behavioral Science, University of Kentucky College of Medicine, 1110 Veterans Drive, Medical Behavioral Science Building Room 140, Lexington, KY 40536-0086, USA; Department of Psychology, University of Kentucky College of Arts and Sciences, 110 Kastle Hall, Lexington, KY 40506-0044, USA; Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY 40509-1810, USA. Electronic address: Craig.Rush@uky.edu.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2020.109974']
3131,32455547,"Exercise Training, Intermittent Fasting and Alkaline Supplementation as an Effective Strategy for Body Weight Loss: A 12-Week Placebo-Controlled Double-Blind Intervention with Overweight Subjects.","BACKGROUND


Intermittent fasting (IF) combined with exercise has been suggested to enhance weight loss. However, both procedures might negatively influence acid-base status. The aim of this study was to determine the combined effects of IF, exercise training and alkaline supplementation in overweight subjects on body composition and running performance.
METHODS


80 overweight subjects of age 45.5 ± 7.8 years were assigned to IF or non-intermittent fasting (nIF). Furthermore, subjects were randomly assigned to take either an alkaline supplement (IF-v, nIF-v) or a placebo (IF-p, nIF-p) twice a day. All subjects performed a personalized endurance exercise program (3-4 times/week for 12 weeks). Body weight, body composition, running performance and acid-base parameters were determined before (pre) and after the 12-week program (post).
RESULTS


68 participants completed the study. There was a significant effect on body weight loss, body fat loss, visceral fat loss and running performance enhancement in all groups ( p  < 0.01) for pre and post measurements. Body weight decreased in all groups (IF-p: -5.80 ± 0.77 kg and nIF-p: -3.40 ± 0.58 kg; IF-v: -8.28 ± 0.75 kg and nIF-v: -5.59 ± 0.87 kg). In both dietary strategies, weight loss was significantly further enhanced by alkaline supplementation. The increase in running velocity was significantly higher in IF combined with alkaline supplementation (IF-v 1.73 ± 0.23 km/h and IF-p 0.97 ± 0.20 km/h). In addition, alkaline supplementation increased plasma HCO 3 -  concentration and urinary pH.
CONCLUSION


Exercise training in combination with IF and alkaline supplementation is an effective strategy to reduce body weight and improve running performance in a 12-week intervention.",2020,"There was a significant effect on body weight loss, body fat loss, visceral fat loss and running performance enhancement in all groups ( p  < 0.01) for pre and post measurements.","['overweight subjects on body composition and running performance', '68 participants completed the study', 'Overweight Subjects', '80 overweight subjects of age 45.5 ± 7.8 years']","['alkaline supplementation', 'personalized endurance exercise program', 'IF or non-intermittent fasting (nIF', 'alkaline supplement (IF-v, nIF-v) or a placebo', 'Placebo-Controlled Double-Blind Intervention', 'Exercise Training, Intermittent Fasting and Alkaline Supplementation', 'exercise training and alkaline supplementation']","['body weight and improve running performance', 'Body weight, body composition, running performance and acid-base parameters', 'Body weight', 'weight loss', 'body weight loss, body fat loss, visceral fat loss and running performance enhancement', 'running velocity', 'Body Weight Loss']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4704881', 'cui_str': 'Intermittent Fasting'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0424630', 'cui_str': 'Loss of body fat - finding'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}]",80.0,0.0651852,"There was a significant effect on body weight loss, body fat loss, visceral fat loss and running performance enhancement in all groups ( p  < 0.01) for pre and post measurements.","[{'ForeName': 'Kuno', 'Initials': 'K', 'LastName': 'Hottenrott', 'Affiliation': 'Institute for Performance Diagnostics and Health Promotion, Martin-Luther-University of Halle-Wittenberg, 06108 Halle, Germany.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Werner', 'Affiliation': 'NuOmix Research k.s. Applied Nutriomic Research, Martin, 81106 Bratislava, Slovaki.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hottenrott', 'Affiliation': 'Faculty of Sport Science, Ruhr-University Bochum, 44801 Bochum, Germany.'}, {'ForeName': 'Till P', 'Initials': 'TP', 'LastName': 'Meyer', 'Affiliation': 'Institute of Sport Science, Martin-Luther-University of Halle-Wittenberg, 06108 Halle, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Vormann', 'Affiliation': 'Institute for Prevention and Nutrition, 85737 Ismaning, Germany.'}]","Life (Basel, Switzerland)",['10.3390/life10050074']
3132,32455565,The Impact of an Early Lifestyle Intervention on Pregnancy Outcomes in a Cohort of Insulin-Resistant Overweight and Obese Women.,"Obese women are more likely to have decreased insulin sensitivity and are at increased risk for many adverse pregnancy outcomes. An early lifestyle intervention (LI) may have the potential to reduce the impact of insulin resistance (IR) on perinatal outcomes. We report post hoc analysis of an open-label randomized control trial that includes IR women with body-mass index ≥25 randomly assigned to a LI with a customized low glycemic index diet or to standard care (SC) involving generic counseling about healthy diet and physical activity. Women were evaluated at 16, 20, 28, and 36 weeks of gestation, at which times perinatal outcomes were collected and analyzed. An oral-glucose-tolerance test (OGTT) showed that women in the LI group had lower plasma glucose levels at 120 min at 16-18 weeks of gestation, and at 60 and 120 min at 24-28 weeks. More importantly, these women had a lower rate of large-for-gestational-age (LGA) infants ( p  = 0.04). Interestingly, the caloric restriction and low-glycemic index diet did not increase the rate of small-for-gestational-age (SGA) babies in the LI group. A lifestyle intervention started early in pregnancy on overweight and obese women had the potential to restore adequate glucose tolerance and mitigate the detrimental role of IR on neonatal outcomes, especially on fetal growth.",2020,"An oral-glucose-tolerance test (OGTT) showed that women in the LI group had lower plasma glucose levels at 120 min at 16-18 weeks of gestation, and at 60 and 120 min at 24-28 weeks.","['Obese women', 'Insulin-Resistant Overweight and Obese Women', 'IR women with body-mass index ≥25 randomly assigned to a', 'overweight and obese women']","['Early Lifestyle Intervention', 'early lifestyle intervention (LI', 'LI with a customized low glycemic index diet or to standard care (SC) involving generic counseling about healthy diet and physical activity', 'oral-glucose-tolerance test (OGTT']","['plasma glucose levels', 'Pregnancy Outcomes', 'rate of small-for-gestational-age (SGA) babies', 'insulin sensitivity', 'caloric restriction and low-glycemic index diet']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}]","[{'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0021296', 'cui_str': 'Small-for-dates baby'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]",,0.0667227,"An oral-glucose-tolerance test (OGTT) showed that women in the LI group had lower plasma glucose levels at 120 min at 16-18 weeks of gestation, and at 60 and 120 min at 24-28 weeks.","[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Menichini', 'Affiliation': 'International Doctorate School in Clinical and Experimental Medicine, Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, 41125 Modena, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Petrella', 'Affiliation': 'Unit of Obstetrics and Gynecology, Mother-Infant Department, University of Modena and Reggio Emilia, 41125 Modena, Italy.'}, {'ForeName': 'Vincenza', 'Initials': 'V', 'LastName': 'Dipace', 'Affiliation': 'Department of Medical and Surgical Sciences for Mother, Child and Adult, University of Modena and Reggio Emilia, University Hospital Policlinic of Modena, 41125 Modena, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Di Monte', 'Affiliation': 'Department of Medical and Surgical Sciences for Mother, Child and Adult, University of Modena and Reggio Emilia, University Hospital Policlinic of Modena, 41125 Modena, Italy.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Neri', 'Affiliation': 'Unit of Obstetrics and Gynecology, Mother-Infant Department, University of Modena and Reggio Emilia, 41125 Modena, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Facchinetti', 'Affiliation': 'Unit of Obstetrics and Gynecology, Mother-Infant Department, University of Modena and Reggio Emilia, 41125 Modena, Italy.'}]",Nutrients,['10.3390/nu12051496']
3133,32455620,Effects of Extra Virgin Olive Oil (EVOO) and the Traditional Brazilian Diet on Sarcopenia in Severe Obesity: A Randomized Clinical Trial.,"BACKGROUND


Nutritional interventions may have positive effects on sarcopenia and body composition.
OBJECTIVE


to evaluate the effectiveness of extra virgin olive oil (EVOO) consumption and a healthy traditional Brazilian diet (DieTBra) on improving sarcopenia indicators and reducing total body fat in severe obesity.
METHODS


A randomized controlled trial registered at ClinicalTrials.gov (NCT02463435) conducted with 111 severely obese participants randomized into three treatment groups-(1) EVOO (52 mL/day), (2) DieTBra, (3) DieTBra + EVOO (52 mL/day)-for 12 weeks. Body composition was assessed by dual-energy X-ray absorptiometry and sarcopenia by walking speed and handgrip strength.
RESULTS


Significant reductions in total body fat ( p  = 0.041) and body weight ( p  = 0.003) were observed in the DieTBra group. In the DietBra + olive oil group there was also a significant reduction in body weight (0.001) compared to the olive oil-only group. ANCOVA analyses showed reductions in total body fat in the DieTBra ( p  = 0.016) and DieTBra + olive oil ( p  = 0.004) groups. Individuals in the DieTBra group had significant improvements in their walking speed ( p  = 0.042) and handgrip strength ( p  = 0.044).
CONCLUSIONS


DieTBra contributes to improvements in handgrip strength, walking speed, and total body fat in severely obese adults. The major study was registered at ClinicalTrials.gov (NCT02463435).",2020,"Individuals in the DieTBra group had significant improvements in their walking speed ( p  = 0.042) and handgrip strength ( p  = 0.044).
","['Severe Obesity', 'severely obese adults', '111 severely obese participants randomized into three treatment groups-(1']","['extra virgin olive oil (EVOO) consumption and a healthy traditional Brazilian diet (DieTBra', 'DietBra + olive oil', 'Extra Virgin Olive Oil (EVOO', 'Traditional Brazilian Diet']","['handgrip strength, walking speed, and total body fat', 'Body composition', 'body weight', 'total body fat', 'handgrip strength', 'walking speed']","[{'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0424677', 'cui_str': 'Total body fat'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",111.0,0.118897,"Individuals in the DieTBra group had significant improvements in their walking speed ( p  = 0.042) and handgrip strength ( p  = 0.044).
","[{'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Aparecida Silveira', 'Affiliation': 'Postgraduate Program in Health Sciences, Faculty of Medicine, Federal University of Goias, Goiânia 74605-220, Goias, Brazil.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Danésio de Souza', 'Affiliation': 'Postgraduate Program in Health Sciences, Faculty of Medicine, Federal University of Goias, Goiânia 74605-220, Goias, Brazil.'}, {'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Dos Santos Rodrigues', 'Affiliation': 'Postgraduate Program in Health Sciences, Faculty of Medicine, Federal University of Goias, Goiânia 74605-220, Goias, Brazil.'}, {'ForeName': 'Ricardo M', 'Initials': 'RM', 'LastName': 'Lima', 'Affiliation': 'Faculty of Physical Education, University of Brasília, Darcy Ribeiro University Campus, Brasília CEP 70910-900, Distrito Federal, Brazil.'}, {'ForeName': 'Camila Kellen', 'Initials': 'CK', 'LastName': 'de Souza Cardoso', 'Affiliation': 'School of Social Sciences and Health, Nutrition Course, Pontifical Catholic University of Goias, Goiânia 74605-020, Brazil.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'de Oliveira', 'Affiliation': 'Department of Epidemiology & Public Health, University College London, London WC1E 6BT, UK.'}]",Nutrients,['10.3390/nu12051498']
3134,32463014,"A Web-Based, Positive Emotion Skills Intervention for Enhancing Posttreatment Psychological Well-Being in Young Adult Cancer Survivors (EMPOWER): Protocol for a Single-Arm Feasibility Trial.","BACKGROUND


Adolescent and young adult cancer survivors (AYAs) experience clinically significant distress and have limited access to supportive care services. Interventions to enhance psychological well-being have improved positive affect and reduced depression in clinical and healthy populations but have not been routinely tested in AYAs.
OBJECTIVE


The aim of this protocol is to (1) test the feasibility and acceptability of a Web-based positive emotion skills intervention for posttreatment AYAs called Enhancing Management of Psychological Outcomes With Emotion Regulation (EMPOWER) and (2) examine proof of concept for reducing psychological distress and enhancing psychological well-being.
METHODS


The intervention development and testing are taking place in 3 phases. In phase 1, we adapted the content of an existing, Web-based positive emotion intervention so that it would be suitable for AYAs. EMPOWER targets 8 skills (noticing positive events, capitalizing, gratitude, mindfulness, positive reappraisal, goal setting, personal strengths, and acts of kindness) and is delivered remotely as a 5-week, Web-based intervention. Phase 2 consisted of a pilot test of EMPOWER in a single-arm trial to evaluate feasibility, acceptability, retention, and adherence and to collect data on psychosocial outcomes for proof of concept. In phase 3, we are refining study procedures and conducting a second pilot test.
RESULTS


The project was part of a career development award. Pilot work began in June 2015, and data collection was completed in March 2019. The analysis is ongoing, and results will be submitted for publication by May 2020.
CONCLUSIONS


If this intervention proves feasible and acceptable, EMPOWER will be primed for a subsequent large, multisite randomized controlled trial. As a scalable intervention, it will be ideally suited for AYA survivors who would otherwise not have access to supportive care interventions to help manage posttreatment distress and enhance well-being.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02832154, https://clinicaltrials.gov/ct2/show/NCT02832154.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/17078.",2020,"Interventions to enhance psychological well-being have improved positive affect and reduced depression in clinical and healthy populations but have not been routinely tested in AYAs.
","['Young Adult Cancer Survivors (EMPOWER', 'Adolescent and young adult cancer survivors']","['Web-based positive emotion skills intervention', 'Positive Emotion Skills Intervention']","['feasibility, acceptability, retention, and adherence']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.173621,"Interventions to enhance psychological well-being have improved positive affect and reduced depression in clinical and healthy populations but have not been routinely tested in AYAs.
","[{'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Salsman', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest Baptist Comprehensive Cancer Center, Wake Forest School of Medicine, Winston Salem, NC, United States.'}, {'ForeName': 'Laurie E', 'Initials': 'LE', 'LastName': 'McLouth', 'Affiliation': 'Department of Behavioral Science, Markey Cancer Center, University of Kentucky College of Medicine, Lexington, KY, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cohn', 'Affiliation': 'Osher Center for Integrative Medicine, University of California San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Janet A', 'Initials': 'JA', 'LastName': 'Tooze', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest Baptist Comprehensive Cancer Center, Wake Forest School of Medicine, Winston Salem, NC, United States.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Sorkin', 'Affiliation': 'Department of Obstetrics & Gynecology, University of Chicago, Chicago, IL, United States.'}, {'ForeName': 'Judith T', 'Initials': 'JT', 'LastName': 'Moskowitz', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}]",JMIR research protocols,['10.2196/17078']
3135,32459987,Client memory and learning of treatment contents: An experimental study of intervention strategies and relationship to outcome in a brief treatment for procrastination.,"BACKGROUND AND OBJECTIVES


Client memory and learning is limited for psychological treatment contents. This study investigated different approaches to support client memory and learning of treatment contents and the relationship between memory and learning of treatment contents and outcome.
METHODS


Adult participants (n = 428) were recruited through Amazon's Mechanical Turk and randomized to complete one of three versions of a one-session procrastination intervention. Two versions of the intervention included different amounts of memory support strategy types from the Memory Support Intervention. A control version did not include any types of memory support. Memory and learning of treatment contents were assessed immediately after the intervention and one week later. Procrastination and two mechanisms of procrastination (impulsiveness and self-efficacy) were assessed at baseline and one week after the intervention.
RESULTS


Contrary to the hypotheses, a version of the intervention with multiple types of memory support strategies was not associated with better memory and learning of treatment contents than a version of the intervention with only one type of memory support strategy or the control intervention. Greater memory and learning of treatment contents predicted improvement in mechanisms of procrastination, but not procrastination itself.
LIMITATIONS


The mean level of procrastination in this study was lower than in other treatment studies of procrastination.
CONCLUSIONS


Results partially support the rationale for the Memory Support Intervention that improving client memory and learning of treatment contents can improve outcome. Findings suggest that the Memory Support Intervention may be simplified to include fewer strategies without compromising efficacy.",2020,"Contrary to the hypotheses, a version of the intervention with multiple types of memory support strategies was not associated with better memory and learning of treatment contents than a version of the intervention with only one type of memory support strategy or the control intervention.",['Adult participants (n\xa0=\xa0428'],"[""Amazon's Mechanical Turk""]","['Memory and learning of treatment contents', 'procrastination (impulsiveness and self-efficacy', 'mean level of procrastination', 'Client memory and learning of treatment contents']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517775', 'cui_str': '428'}]","[{'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0337911', 'cui_str': 'Turks'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0871142', 'cui_str': 'Procrastination'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008942', 'cui_str': 'Clients'}]",428.0,0.032357,"Contrary to the hypotheses, a version of the intervention with multiple types of memory support strategies was not associated with better memory and learning of treatment contents than a version of the intervention with only one type of memory support strategy or the control intervention.","[{'ForeName': 'Garret G', 'Initials': 'GG', 'LastName': 'Zieve', 'Affiliation': 'University of California, Berkeley, United States.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Woodworth', 'Affiliation': 'University of California, Berkeley, United States.'}, {'ForeName': 'Allison G', 'Initials': 'AG', 'LastName': 'Harvey', 'Affiliation': 'University of California, Berkeley, United States. Electronic address: aharvey@berkeley.edu.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101579']
3136,32460116,The marathon of labour-Does regular exercise training influence course of labour and mode of delivery?: Secondary analysis from a randomized controlled trial.,"OBJECTIVES


Today all pregnant women are recommended to participate in moderate intensity aerobic and resistance-based physical activity/exercise ≥150 min/week. However, there are still controversies and scant knowledge on the role of regular exercise on delivery outcomes, including mode of delivery and length of active labour. In addition, nutritional counselling have often been examined together with exercise, which may independently effect the outcomes. Hence, the aims of the present study were to investigate the sole effect of supervised group exercise, including pelvic floor muscle training on course of labour and mode of delivery.
STUDY DESIGN


A single blind, randomized controlled trial, performed in the municipality of Oslo, Norway. Out of 105 healthy, inactive nulliparous women, initially enrolled (gestation week 17.7 ± 4.2) to study the effect regular aerobic exercise (60 min 2/week) on health benefits for both mother and her baby, 90 (85.7%) completed postpartum follow-up (7.7 ± 1.7) on labour outcomes (exercise: 43 and control: 47). Data were collected via standardized interviews and birth partographs from hospital records, reported on the postpartum visit (weeks after labour 7.6 ± 1.6). The primary investigator was unaware of the original randomization at the time of the interviews. The principal analysis was done on an intention to treat basis (ITT). For the planned subgroup analyses (per protocol), acceptable intervention adherence was defined as attending ≥ 80% of the recommended exercise program (≥ 19 exercise sessions).
RESULTS


There were no differences between the exercise and control groups in induction of labour, use of analgesia, duration of active labour or prolonged labour, according to ITT. Per protocol analyses, showed a shorter duration of total active labour in the exercise group (6.8 ± 5.5 h) than the control group (9.8 ± 5.4 h), with a mean between group difference of 3.1 h (95% CI 0.31-5.9, p = 0.029). Rate of normal vaginal delivery was 85.7% among adherent participants and 62.3% in the control group (p = 0.051).
CONCLUSIONS


Regular exercise during pregnancy decreased duration of total active labour and showed a trend towards more normal vaginal deliveries among participants who adhered to the prescribed program.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT00617149.",2020,"There were no differences between the exercise and control groups in induction of labour, use of analgesia, duration of active labour or prolonged labour, according to ITT.","['60\u2009min 2/week) on health benefits for both mother and her baby, 90 (85.7%) completed postpartum follow-up (7.7\u2009±\u20091.7) on labour outcomes (exercise: 43 and control: 47', 'Today all pregnant women', '105 healthy, inactive nulliparous women, initially enrolled (gestation week 17.7\u2009±\u20094.2) to study the effect', 'municipality of Oslo, Norway']","['regular exercise training', 'Regular exercise', 'regular aerobic exercise', 'supervised group exercise, including pelvic floor muscle training']","['normal vaginal deliveries', 'duration of total active labour', 'shorter duration of total active labour', 'Rate of normal vaginal delivery', 'induction of labour, use of analgesia, duration of active labour or prolonged labour, according to ITT', 'acceptable intervention adherence']","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0086387', 'cui_str': 'Health Benefits'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517860', 'cui_str': '7.7'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0310367', 'cui_str': 'Today'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4517598', 'cui_str': '17.7'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0028423', 'cui_str': 'Norway'}]","[{'cui': 'C0582191', 'cui_str': 'Regular exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}]","[{'cui': 'C0269694', 'cui_str': 'Normal delivery procedure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0233081', 'cui_str': 'Normal labor'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0152154', 'cui_str': 'Prolonged labor'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",105.0,0.114603,"There were no differences between the exercise and control groups in induction of labour, use of analgesia, duration of active labour or prolonged labour, according to ITT.","[{'ForeName': 'Lene A H', 'Initials': 'LAH', 'LastName': 'Haakstad', 'Affiliation': 'Associate Professor, Exercise Scientist, Norwegian School of Sports Sciences, Department of Sports Medicine, PO Box 4014, Ullevål Stadion, Oslo, Norway. Electronic address: lahaakstad@nih.no.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Bø', 'Affiliation': 'Professor, Exercise Scientist, Physical Therapist, Norwegian School of Sports Sciences, Department of Sports Medicine, Norway. Electronic address: kari.bo@nih.no.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.05.014']
3137,32460138,Social timing influences sleep quality in patients with sleep disorders.,"OBJECTIVES


We aimed to compare three variants of the Pittsburgh Sleep Quality Index (PSQI usual, work- and work-free days: PSQI u , PSQI w , PSQI f ) and to assess whether chronotype (MSF sc )/social jetlag (SJL) are associated with sleep quality in patients with sleep disorders (SD).
METHODS


In sum, 431 SD patients and 338 subjects from the general population (GP) were included. Participants filled in three variants of the PSQI and the Munich ChronoType Questionnaire (MCTQ). We used Generalized Estimating Equations (GEE) to investigate effects of group (GP, SD), PSQI (usual, work or free) and their interaction (group∗PSQI) on scores. To investigate associations between MSF sc /SJL and the difference between PSQI w  and PSQI f  (PSQI diff ) in patients with SD we used linear regressions (N = 352). We used Sobel to test whether there was a mediation effect of SJL on the association between MSF sc  and PSQI diff .
RESULTS


PSQI scores differed between groups (p < 0.001). Post-hoc analysis revealed a significant difference between PSQI u  vs. PSQI f  and PSQI w  vs. PSQI f  with PSQI f  presenting lower scores, while PSQI u  vs. PSQI w  did not differ in any group. In line with previous findings, SJL was associated to PSQI diff  in SD patients.
CONCLUSIONS


PSQI u  mainly represents sleep quality on workdays also in SD patients. Being a late chronotype seems to be associated with higher differences in sleep quality on work-vs. free days mostly when it coincides with societal time constraints. Since sleep quality is poorer on workdays even in SD patients, we suggest that treatment strategies should address social aspects affecting sleep, including ways of minimizing SJL.",2020,"f  presenting lower scores, while PSQI u  vs. PSQI w  did not differ in any group.","['patients with sleep disorders (SD', 'patients with SD', 'patients with sleep disorders', '431 SD patients and 338 subjects from the general population (GP) were included', 'SD patients']","['chronotype (MSF sc )/social jetlag (SJL', 'MSF sc /SJL', 'PSQI', 'SJL']","['PSQI (usual, work or free) and their interaction (group∗PSQI) on scores', 'PSQI u  vs. PSQI f  and PSQI w  vs. PSQI', 'Pittsburgh Sleep Quality Index (PSQI usual, work- and work-free days: PSQI u , PSQI w , PSQI f ', 'PSQI scores', 'Munich ChronoType Questionnaire (MCTQ', 'sleep quality', 'PSQI w  and PSQI f  (PSQI diff ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0231311', 'cui_str': 'Jet lag'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}]","[{'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",,0.0284205,"f  presenting lower scores, while PSQI u  vs. PSQI w  did not differ in any group.","[{'ForeName': 'Cátia', 'Initials': 'C', 'LastName': 'Reis', 'Affiliation': 'CENC - Centro de Medicina de Sono, Lisbon, Portugal; ISAMB - Faculty of Medicine, University of Lisbon, Portugal; IMM - Faculty of Medicine João Lobo Antunes, University of Lisbon, Portugal.'}, {'ForeName': 'Luísa K', 'Initials': 'LK', 'LastName': 'Pilz', 'Affiliation': 'Institute of Medical Psychology, Center for Chronobiology, Medical Faculty, LMU, Munich, Germany; Laboratório de Cronobiologia e Sono, HCPA/UFRGS, Porto Alegre, RS, Brazil; PPG em Psiquiatria e Ciências do Comportamento, UFRGS, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Lena Katharina', 'Initials': 'LK', 'LastName': 'Keller', 'Affiliation': 'Institute of Medical Psychology, Center for Chronobiology, Medical Faculty, LMU, Munich, Germany; Department of Child and Adolescent Psychiatry, University Hospital Munich, Munich, Germany.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Paiva', 'Affiliation': 'CENC - Centro de Medicina de Sono, Lisbon, Portugal; ISAMB - Faculty of Medicine, University of Lisbon, Portugal; CHRC - Nova Medical School - Faculdade de Ciências Médicas, Lisbon, Portugal.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Roenneberg', 'Affiliation': 'Institute of Medical Psychology, Center for Chronobiology, Medical Faculty, LMU, Munich, Germany. Electronic address: roenneberg@lmu.de.'}]",Sleep medicine,['10.1016/j.sleep.2020.02.019']
3138,32460145,Effect of cognitive rehabilitation on neuropsychological and semiecological testing and on daily cognitive functioning in multiple sclerosis: The REACTIV randomized controlled study.,"BACKGROUND


Specific cognitive rehabilitation (SCR) has been suggested for multiple sclerosis (MS). A randomized controlled trial (RCT) evaluating the therapeutic effects of SCR is necessary.
OBJECTIVE


To demonstrate the superiority of a SCR program (REACTIV) over nonspecific intervention (NSI) for neuropsychological (NP) assessment, virtual reality (VR) cognitive testing and daily cognitive functioning.
METHODS


A single-blind RCT compared SCR and NSI in patients with MS with cognitive complaint. Both programs included 50 individual sessions, 3 times a week for 17 weeks in a real-world setting. The primary end-point was NP assessment. Secondary end-points included semiecological VR tasks (Urban Daily Cog®) and daily cognitive functioning assessment. Maintenance of the effects at 8 months was studied.
RESULTS


Of the 35 patients, 18 completed the SCR, and 17 completed the NSI. Several NP and semiecological scores improved significantly more after SCR than after NSI. More NP scores improved significantly after SCR than after NSI. SCR improved daily cognitive functioning. Most improvements were maintained at 8 months.
CONCLUSION


SCR performed in a real-world setting is superior to NSI for improving performance in specific cognitive domains and information processing speed, and for improving cognitive functioning, as evaluated by ecological tools close to daily life and a daily cognitive functioning questionnaire.",2020,"CONCLUSION


SCR performed in a real-world setting is superior to NSI for improving performance in specific cognitive domains and information processing speed, and for improving cognitive functioning, as evaluated by ecological tools close to daily life and a daily cognitive functioning questionnaire.","['35 patients', 'patients with MS with cognitive complaint', 'multiple sclerosis']","['Specific cognitive rehabilitation (SCR', 'cognitive rehabilitation', 'SCR program (REACTIV) over nonspecific intervention (NSI) for neuropsychological (NP) assessment, virtual reality (VR) cognitive testing and daily cognitive functioning']","['SCR improved daily cognitive functioning', 'semiecological VR tasks (Urban Daily Cog®) and daily cognitive functioning assessment', 'NP scores', 'Several NP and semiecological scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.067952,"CONCLUSION


SCR performed in a real-world setting is superior to NSI for improving performance in specific cognitive domains and information processing speed, and for improving cognitive functioning, as evaluated by ecological tools close to daily life and a daily cognitive functioning questionnaire.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lamargue', 'Affiliation': 'Univ. Bordeaux, F-33000 Bordeaux, France; Inserm U1215 - Neurocentre Magendie, F-33000 Bordeaux, France.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Koubiyr', 'Affiliation': 'Univ. Bordeaux, F-33000 Bordeaux, France; Inserm U1215 - Neurocentre Magendie, F-33000 Bordeaux, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Deloire', 'Affiliation': 'CHU de Bordeaux, F-33000 Bordeaux, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Saubusse', 'Affiliation': 'CHU de Bordeaux, F-33000 Bordeaux, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Charre-Morin', 'Affiliation': 'CHU de Bordeaux, F-33000 Bordeaux, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Moroso', 'Affiliation': 'CHU de Bordeaux, F-33000 Bordeaux, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Coupé', 'Affiliation': 'Laboratoire Bordelais de Recherche en Informatique, UMR CNRS 5800, PICTURA, F-33405 Talence, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Brochet', 'Affiliation': 'Univ. Bordeaux, F-33000 Bordeaux, France; Inserm U1215 - Neurocentre Magendie, F-33000 Bordeaux, France; CHU de Bordeaux, F-33000 Bordeaux, France. Electronic address: bruno.brochet@chu-bordeaux.fr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ruet', 'Affiliation': 'Univ. Bordeaux, F-33000 Bordeaux, France; Inserm U1215 - Neurocentre Magendie, F-33000 Bordeaux, France; CHU de Bordeaux, F-33000 Bordeaux, France.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116929']
3139,32466187,Effect of Different Running Exercise Modalities on Post-Exercise Oxidative Stress Markers in Trained Athletes.,"The aim of this study was to examine the effect of running exercise modality on oxidative stress. Thirteen endurance athletes (age: 21.46 ± 0.66 years) performed three different running exercise modalities (Continuous running exercise (CR): continuous running exercise at 75% of VO 2max  for 25 min; intermittent running exercise #1 (15/15): intermittent running protocol, 15 s running at 75% of VO 2max , 15 s passive recovery, performed for 50 min; intermittent running exercise #2 (30/30): intermittent running protocol, 30 s running at 75% of VO 2max , 30 s passive recovery, performed for 50 min) in a randomized order. Blood samples were drawn at rest and immediately after each running exercise and assessed for malondialdehyde (MDA), advanced oxidation protein products (AOPP), superoxide dismutase(SOD), and glutathione peroxidase (GPX) activities. MDA increased by 55% following 30/30 exercise ( p  < 0.01), while it remained unchanged with CR and15/15 exercise. SOD increased after CR (+13.9%,  p  < 0.05), and also remained unchanged after 15/15 ( p  > 0.05) and decreased after 30/30 (-19.7%  p  < 0.05). GPX and AOPP did not change after exercise in all experimental sessions ( p  > 0.05). In conclusion, 30/30 intermittent running induced higher lipid damages than the 15/15 and CR exercise. 15/15 intermittent exercise promoted a better balance between free radicals production and antioxidant defense compared to continuous exercise and intermittent 30/30 exercise.",2020,"MDA increased by 55% following 30/30 exercise ( p  < 0.01), while it remained unchanged with CR and15/15 exercise.","['Thirteen endurance athletes (age: 21.46 ± 0.66 years', 'Trained Athletes']","['running exercise modalities (Continuous running exercise (CR): continuous running exercise at 75% of VO 2max  for 25 min; intermittent running exercise #1 (15/15): intermittent running protocol, 15 s running at 75% of VO 2max , 15 s passive recovery, performed for 50 min; intermittent running exercise #2 (30/30): intermittent running protocol, 30 s running at 75% of VO 2max', 'Different Running Exercise Modalities', 'running exercise modality']","['SOD', 'oxidative stress', 'malondialdehyde (MDA), advanced oxidation protein products (AOPP), superoxide dismutase(SOD), and glutathione peroxidase (GPX) activities', 'GPX and AOPP', 'MDA', 'lipid damages', 'Post-Exercise Oxidative Stress Markers']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C1976991', 'cui_str': 'Advanced oxidation protein products'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",13.0,0.0473095,"MDA increased by 55% following 30/30 exercise ( p  < 0.01), while it remained unchanged with CR and15/15 exercise.","[{'ForeName': 'Wajdi', 'Initials': 'W', 'LastName': 'Souissi', 'Affiliation': 'Research Laboratory: Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education, University of Sfax, Sfax 3000, Tunisia.'}, {'ForeName': 'Mohamed Amine', 'Initials': 'MA', 'LastName': 'Bouzid', 'Affiliation': 'Research Laboratory: Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education, University of Sfax, Sfax 3000, Tunisia.'}, {'ForeName': 'Mohamed Amine', 'Initials': 'MA', 'LastName': 'Farjallah', 'Affiliation': 'Research Laboratory: Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education, University of Sfax, Sfax 3000, Tunisia.'}, {'ForeName': 'Lobna', 'Initials': 'L', 'LastName': 'Ben Mahmoud', 'Affiliation': 'Pharmacology Department, Faculty of Medicine, University of Sfax, Sfax 3000, Tunisia.'}, {'ForeName': 'Mariem', 'Initials': 'M', 'LastName': 'Boudaya', 'Affiliation': 'Biochemistry Laboratory, CHU HediChaker, University of Sfax, Sfax 3000, Tunisia.'}, {'ForeName': 'Florian A', 'Initials': 'FA', 'LastName': 'Engel', 'Affiliation': 'Institute of Sport and Sport Science, Heidelberg University, 69120 Heidelberg, Germany.'}, {'ForeName': 'Zouheir', 'Initials': 'Z', 'LastName': 'Sahnoun', 'Affiliation': 'Pharmacology Department, Faculty of Medicine, University of Sfax, Sfax 3000, Tunisia.'}]",International journal of environmental research and public health,['10.3390/ijerph17103729']
3140,32468730,"Feasibility, acceptability and affective consequences of at-home sleep extension in young women with depressive symptoms: A pilot study.","Insufficient sleep is common in young adults and has meaningful consequences for daytime functioning, including increased sleepiness, affective disruption and depressive symptoms. This study provides a preliminary evaluation of the feasibility, acceptability and affective consequences of extended sleep opportunity in young women with insufficient sleep and depressive symptoms. Participants were 32 women, 18-22 years of age, who regularly obtained less than 8-hr sleep/night and had daytime sleepiness and depressive symptoms at or above population averages. Participants were asked to maintain a sleep schedule of their typical duration for 7 days and were then randomly assigned to either extend sleep opportunity (ESO) by 90 min per night or maintain typical sleep opportunity (TSO), for the next 7 days. Sleep characteristics and daytime sleepiness were measured using continuous actigraphy and daily sleep diary, and affect, stress and depressive symptoms were assessed with daily and weekly questionnaires. Extended sleep opportunity increased sleep duration by over 1 hr, improved morning sleepiness and positive affect, and diminished anhedonia and depressive symptoms in study completers (n = 11 ESO, 11 TSO). However, 31.3% of participants (n = 10) were withdrawn from the study due to difficulty maintaining the sleep schedule. These results provide initial evidence that sleep extension is beneficial for young women who usually have inadequate sleep and mood disruption and can maintain a consistent sleep schedule. If extending sleep opportunity improves sleep, daytime sleepiness and affect in young adults who typically have insufficient sleep, it could broaden the range of interventions for sleep and mental wellness.",2020,"Extended sleep opportunity increased sleep duration by over 1 hr, improved morning sleepiness and positive affect, and diminished anhedonia and depressive symptoms in study completers (n = 11 ESO, 11 TSO).","['Participants were 32 women, 18-22\xa0years of age, who regularly obtained less than 8-hr sleep/night and had daytime sleepiness and depressive symptoms at or above population averages', 'young adults', 'young women with depressive symptoms', 'young adults who typically have insufficient sleep', 'young women with insufficient sleep and depressive symptoms']",['extend sleep opportunity (ESO) by 90\xa0min per night or maintain typical sleep opportunity (TSO'],"['continuous actigraphy and daily sleep diary, and affect, stress and depressive symptoms', 'sleep duration', 'Sleep characteristics and daytime sleepiness', 'sleep, daytime sleepiness', 'Feasibility, acceptability and affective consequences', 'morning sleepiness and positive affect, and diminished anhedonia and depressive symptoms']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}]","[{'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}]",32.0,0.050675,"Extended sleep opportunity increased sleep duration by over 1 hr, improved morning sleepiness and positive affect, and diminished anhedonia and depressive symptoms in study completers (n = 11 ESO, 11 TSO).","[{'ForeName': 'Melynda D', 'Initials': 'MD', 'LastName': 'Casement', 'Affiliation': 'Department of Psychology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Nicholas R', 'Initials': 'NR', 'LastName': 'Livingston', 'Affiliation': 'Department of Psychology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Nicholas B', 'Initials': 'NB', 'LastName': 'Allen', 'Affiliation': 'Department of Psychology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Erika E', 'Initials': 'EE', 'LastName': 'Forbes', 'Affiliation': 'Western Psychiatric Institute and Clinic, Pittsburgh, Pennsylvania.'}]",Journal of sleep research,['10.1111/jsr.13045']
3141,32449896,Peritoneal Flap in Robot-Assisted Radical Prostatectomy.,"BACKGROUND


Lymphocele is the most common complication arising after pelvic lymph node dissection (PLND) in the setting of robot-assisted radical prostatectomy (RARP). The only data available until now on the utility of a peritoneal flap to prevent lymphocele were retrospectively acquired.
METHODS


A randomized, controlled, multi-center trial with blinded assessment of endpoints was carried out on 232 patients with prostate cancer who underwent RARP with PLND. The patients in the intervention group were given a peritoneal flap; in the control group, surgery was performed without this modification. The two joint primary endpoints were the rates of symptomatic lymphocele during the same hospitalization as the operative procedure (iT1) and within 90 days of surgery (iT2). The secondary endpoints were lymphocele volume, the need for treatment of lymphocele, complications requiring an intervention, and the degree of postoperative stress incontinence. German Clinical Trials Register number: DRKS00011115.
RESULTS


The data were evaluated in an intention-to-treat analysis, which, in this trial, was identical to an as-treated analysis. 108 patients (46.6%) were allotted to the intervention group. There were no statistically significant intergroup differences with respect to any clinical or histopathological criteria. A median of 16 lymph nodes were removed (interquartile range, 11-21). A symptomatic lymphocele arose in 1.3% (iT1) and 9.1% (iT2) of the patients, without any statistically significant difference between the two trial groups (p = 0.599 and p = 0.820, respectively). Nor did the groups differ significantly with respect to lymphocele volume (p = 0.670 on hospital discharge [T1], p = 0.650 90 days after surgery [T2]) or the type and frequency of need for subsequent surgical intervention (p = 0.535; iT2). 81.5% of all patients (n = 189) had no complications at all in the first three months after surgery. Nor were there any intergroup differences at 90 days with respect to the degree of stress urinary incontinence (p = 0.306) or complications (p = 0.486).
CONCLUSION


A peritoneal flap after RARP was not found to influence the rate of postoperative lymphocele, whether asymptomatic or requiring treatment.",2020,"Nor did the groups differ significantly with respect to lymphocele volume (p = 0.670 on hospital discharge [T1], p = 0.650 90 days after surgery [T2]) or the type and frequency of need for subsequent surgical intervention (p = 0.535; iT2).","['232 patients with prostate cancer who underwent RARP with PLND', '108 patients (46.6']","['Peritoneal Flap in Robot-Assisted Radical Prostatectomy', 'peritoneal flap', 'robot-assisted radical prostatectomy (RARP']","['degree of stress urinary incontinence', 'rate of postoperative lymphocele', 'lymphocele volume, the need for treatment of lymphocele, complications requiring an intervention, and the degree of postoperative stress incontinence', 'rates of symptomatic lymphocele during the same hospitalization as the operative procedure (iT1) and within 90 days of surgery (iT2', 'lymphocele volume', 'symptomatic lymphocele', 'no complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0193883', 'cui_str': 'Pelvic lymphadenectomy'}, {'cui': 'C4517530', 'cui_str': '108'}]","[{'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C1998084', 'cui_str': 'Lymphocele after surgical procedure'}, {'cui': 'C0024248', 'cui_str': 'Lymphocele'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",232.0,0.0672329,"Nor did the groups differ significantly with respect to lymphocele volume (p = 0.670 on hospital discharge [T1], p = 0.650 90 days after surgery [T2]) or the type and frequency of need for subsequent surgical intervention (p = 0.535; iT2).","[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Bründl', 'Affiliation': 'Department of Urology, University of Regensburg, Caritas St. Josef Medical Center, Regensburg, Germany; Department of Urology and Andrology, Hospital of St. John of God (Krankenhaus der Barmherzigen Brüder Wien), Vienna, Austria; Department of Urology and Andrology, Paracelsus Medical University Salzburg, Salzburg, Austria; Department of Urology, St. Elisabeth Hospital Straubing, Straubing, Germany; Department of Urology, Vivantes Humboldt Hospital Berlin, Berlin Germany; These two authors are co-first authors.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Lenart', 'Affiliation': ''}, {'ForeName': 'Gjoko', 'Initials': 'G', 'LastName': 'Stojanoski', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gilfrich', 'Affiliation': ''}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Rosenhammer', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stolzlechner', 'Affiliation': ''}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Ponholzer', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Dreissig', 'Affiliation': ''}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Weikert', 'Affiliation': ''}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Burger', 'Affiliation': ''}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'May', 'Affiliation': ''}]",Deutsches Arzteblatt international,['10.3238/arztebl.2020.0243']
3142,32450367,Measures of adherence as predictors of early and total weight loss with intensive behavioral therapy for obesity combined with liraglutide 3.0 mg.,"Individual weight loss outcomes with intensive behavioral therapy (IBT) for obesity are variable. The present study assessed whether visit attendance, dietary self-monitoring, medication, and meal-replacement adherence were associated with 52-week weight loss with IBT and tested whether these relationships were independent of associations with early weight loss. This was a secondary analysis of a randomized trial in which 150 participants (76.1% female, 55.8% white, BMI = 38.8 ± 4.8 kg/m 2 ) received either IBT alone, IBT with liraglutide 3.0 mg/d, or IBT-liraglutide combined with a 12-week meal replacement diet (Multi-component). In the full sample, visit attendance accounted for 14.8% of the variance in 52-week weight loss and dietary self-monitoring added 14.9%. Only self-monitoring was independently associated with weight loss. In the 100 liraglutide-treated participants, medication adherence accounted for an additional 9.9% of the variance in 52-week weight loss, and both self-monitoring and medication adherence were independent correlates. For the 50 Multi-component participants, meal replacement adherence did not predict weight loss. Early weight loss was associated with higher early and subsequent session attendance and dietary self-monitoring. However, self-monitoring and medication adherence remained important correlates of total weight loss when controlling for this variable. Strategies that help improve self-monitoring consistency and medication usage could improve weight loss with IBT.",2020,"In the full sample, visit attendance accounted for 14.8% of the variance in 52-week weight loss and dietary self-monitoring added 14.9%.","['150 participants (76.1% female, 55.8% white, BMI\u202f=\u202f38.8\u202f±\u202f4.8\u202fkg/m 2 ']","['intensive behavioral therapy (IBT', 'IBT alone, IBT with liraglutide 3.0\u202fmg/d, or IBT-liraglutide combined with a 12-week meal replacement diet (Multi-component', 'liraglutide']","['Early weight loss', 'weight loss', 'total weight loss', 'visit attendance, dietary self-monitoring, medication, and meal-replacement adherence', 'self-monitoring and medication adherence', 'medication adherence']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517765', 'cui_str': '4.8'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",150.0,0.0213041,"In the full sample, visit attendance accounted for 14.8% of the variance in 52-week weight loss and dietary self-monitoring added 14.9%.","[{'ForeName': 'Jena S', 'Initials': 'JS', 'LastName': 'Tronieri', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, USA. Electronic address: jena.tronieri@pennmedicine.upenn.edu.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, USA.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Walsh', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, USA.'}, {'ForeName': 'Robert I', 'Initials': 'RI', 'LastName': 'Berkowitz', 'Affiliation': ""Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, USA; The Children's Hospital of Philadelphia, Department of Child and Adolescent Psychiatry, Philadelphia, PA, USA.""}, {'ForeName': 'Naji', 'Initials': 'N', 'LastName': 'Alamuddin', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Department of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Ariana M', 'Initials': 'AM', 'LastName': 'Chao', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, USA; University of Pennsylvania School of Nursing, Department of Biobehavioral Health Sciences, Philadelphia, PA, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103639']
3143,32450456,The impact of pre-procedure heart rate on adverse clinical outcomes in patients undergoing percutaneous coronary intervention: Results from a 2-year follow-up of the GLOBAL LEADERS trial.,"BACKGROUND AND AIMS


The prognostic impact of pre-procedure heart rate (PHR) following percutaneous coronary intervention (PCI) has not yet been fully investigated. This post-hoc analysis sought to assess the impact of PHR on medium-term outcomes among patients having PCI, who were enrolled in the ""all-comers"" GLOBAL LEADERS trial.
METHODS AND RESULTS


The primary endpoint (composite of all-cause death or new Q-wave myocardial infarction [MI]) and key secondary safety endpoint (bleeding according to Bleeding Academic Research Consortium [BARC] type 3 or 5) were assessed at 2 years. PHR was available in 15,855 patients, and when evaluated as a continuous variable (5 bpm increase) and following adjustment using multivariate Cox regression, it significantly correlated with the primary endpoint (hazard ratio [HR] 1.06, 95% confidence interval [CI] 1.03-1.09, p < 0.001). Using dichotomous cut-off criteria, a PHR>67 bpm was associated with increased all-cause mortality (HR 1.38, 95%CI 1.13-1.69, p = 0.002) and more frequent new Q-wave MI (HR 1.41, 95%CI 1.02-1.93, p = 0.037). No significant association was found between PHR and BARC 3 or 5 bleeding (HR 1.04, 95% CI 0.99-1.09, p = 0.099). There was no interaction with the primary (p-inter = 0.236) or secondary endpoint (p-inter = 0.154) when high and low PHR was analyzed according to different antiplatelet strategies.
CONCLUSIONS


Elevated PHR was an independent predictor of all-cause mortality at 2 years following PCI in the ""all-comer"" GLOBAL LEADERS trial. The prognostic value of increased PHR on outcomes was not affected by the different antiplatelet strategies in this trial.",2020,"No significant association was found between PHR and BARC 3 or 5 bleeding (HR 1.04, 95% CI 0.99-1.09, p = 0.099).","['patients undergoing percutaneous coronary intervention', 'patients having PCI, who were enrolled in the ""all-comers"" GLOBAL LEADERS trial']",['percutaneous coronary intervention (PCI'],"['PHR and BARC 3 or 5 bleeding', 'primary endpoint (composite of all-cause death or new Q-wave myocardial infarction [MI]) and key secondary safety endpoint (bleeding according to Bleeding Academic Research Consortium [BARC] type 3 or 5', 'PHR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0429089', 'cui_str': 'Electrocardiogram Q waves'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}]",,0.296061,"No significant association was found between PHR and BARC 3 or 5 bleeding (HR 1.04, 95% CI 0.99-1.09, p = 0.099).","[{'ForeName': 'Rutao', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': ""Department of Cardiology, Xijing Hospital, Fourth Military Medical University, Xi'an, China; Department of Cardiology, Radboudumc, Nijmegen, the Netherlands; Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.""}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Ply', 'Initials': 'P', 'LastName': 'Chichareon', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands; Cardiology Unit, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': ""Department of Cardiology, Xijing Hospital, Fourth Military Medical University, Xi'an, China; Department of Cardiology, Radboudumc, Nijmegen, the Netherlands; Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.""}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kogame', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Modolo', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands; Department of Internal Medicine, Cardiology Division, University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': 'Department of Cardiology, Erasmus Medical University Center, Thorax Centre, Rotterdam, the Netherlands; First Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Kawashima', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Schächinger', 'Affiliation': 'Klinikum Fulda, Medizinische Klinik I, Fulda, Germany.'}, {'ForeName': 'Gincho', 'Initials': 'G', 'LastName': 'Tonev', 'Affiliation': ""Multi-profile Hospital for Active Treatment, St George's University, Plovdiv, Bulgaria.""}, {'ForeName': 'Imre', 'Initials': 'I', 'LastName': 'Ungi', 'Affiliation': 'Division of Invasive Cardiology, Second Department of Internal Medicine and Cardiology Center, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Botelho', 'Affiliation': 'CT / Instituto Do Coracao Do Triangulo Mineiro, Uberlandia, Brazil.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Eeckhout', 'Affiliation': 'Department of Cardiology, Lausanne University Hospital, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'Kerckhoff Heart Center, Campus University of Giessen, Bad Nauheim, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Scot', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': 'East Lancashire Hospitals NHS Trust, Blackburn, Lancashire, United Kingdom.'}, {'ForeName': 'Robert Jan', 'Initials': 'RJ', 'LastName': 'Van Geuns', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; Department of Cardiology, Erasmus Medical University Center, Thorax Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; National Heart and Lung Institute, Imperial College London, London, UK. Electronic address: patrick.w.j.c.serruys@gmail.com.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2020.04.010']
3144,32452356,Fluoxetine to improve functional outcomes in patients after acute stroke: the FOCUS RCT.,"BACKGROUND


Our Cochrane review of selective serotonin inhibitors for stroke recovery indicated that fluoxetine may improve functional recovery, but the trials were small and most were at high risk of bias.
OBJECTIVES


The Fluoxetine Or Control Under Supervision (FOCUS) trial tested the hypothesis that fluoxetine improves recovery after stroke.
DESIGN


The FOCUS trial was a pragmatic, multicentre, parallel-group, individually randomised, placebo-controlled trial.
SETTING


This trial took place in 103 UK hospitals.
PARTICIPANTS


Patients were eligible if they were aged ≥ 18 years, had a clinical stroke diagnosis, with focal neurological deficits, between 2 and 15 days after onset.
INTERVENTIONS


Patients were randomly allocated 20 mg of fluoxetine once per day or the matching placebo for 6 months via a web-based system using a minimisation algorithm.
MAIN OUTCOME MEASURES


The primary outcome was the modified Rankin Scale at 6 months. Patients, carers, health-care staff and the trial team were masked to treatment allocation. Outcome was assessed at 6 and 12 months after randomisation. Patients were analysed by their treatment allocation as specified in a published statistical analysis plan.
RESULTS


Between 10 September 2012 and 31 March 2017, we recruited 3127 patients, 1564 of whom were allocated fluoxetine and 1563 of whom were allocated placebo. The modified Rankin Scale score at 6 months was available for 1553 out of 1564 (99.3%) of those allocated fluoxetine and 1553 out of 1563 (99.4%) of those allocated placebo. The distribution across modified Rankin Scale categories at 6 months was similar in the two groups (common odds ratio adjusted for minimisation variables 0.951, 95% confidence interval 0.839 to 1.079;  p  = 0.439). Compared with placebo, patients who were allocated fluoxetine were less likely to develop a new episode of depression by 6 months [210 (13.0%) vs. 269 (16.9%), difference -3.78%, 95% confidence interval -1.26% to -6.30%;  p  = 0.003], but had more bone fractures [45 (2.9%) vs. 23 (1.5%), difference 1.41%, 95% confidence interval 0.38% to 2.43%;  p  = 0.007]. There were no statistically significant differences in any other recorded events at 6 or 12 months. Health economic analyses showed no differences between groups in health-related quality of life, hospital bed usage or health-care costs.
LIMITATIONS


Some non-adherence to trial medication, lack of face-to-face assessment of neurological status at follow-up and lack of formal psychiatric diagnosis during follow-up.
CONCLUSIONS


20 mg of fluoxetine daily for 6 months after acute stroke did not improve patients' functional outcome but decreased the occurrence of depression and increased the risk of fractures. These data inform decisions about using fluoxetine after stroke to improve functional outcome or to prevent or treat mood disorders. The Assessment oF FluoxetINe In sTroke recoverY (AFFINITY) (Australasia/Vietnam) and Efficacy oF Fluoxetine - a randomisEd Controlled Trial in Stroke (EFFECTS) (Sweden) trials recruited an additional 2780 patients and will report their results in 2020. These three trials have an almost identical protocol, which was collaboratively developed. Our planned individual patient data meta-analysis will provide more precise estimates of the effects of fluoxetine after stroke and indicate whether or not effects vary depending on patients' characteristics and health-care setting.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN83290762.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 24, No. 22. See the NIHR Journals Library website for further project information. The Stroke Association (reference TSA 2011101) funded the start-up phase.",2020,"Health economic analyses showed no differences between groups in health-related quality of life, hospital bed usage or health-care costs.
","['Patients were eligible if they were aged ≥\u200918 years, had a clinical stroke diagnosis, with focal neurological deficits, between 2 and 15 days after onset', 'patients after acute stroke', 'Stroke (EFFECTS) (Sweden) trials recruited an additional 2780 patients and will report their results in 2020', '103 UK hospitals', 'Between 10 September 2012 and 31 March 2017, we recruited 3127 patients, 1564 of whom were allocated']","['fluoxetine once per day or the matching placebo', 'FluoxetINe', 'Fluoxetine Or Control', 'fluoxetine', 'Fluoxetine', 'placebo']","['occurrence of depression', 'new episode of depression', 'modified Rankin Scale', 'bone fractures', 'risk of fractures', ""patients' functional outcome"", 'modified Rankin Scale score', 'functional recovery', 'functional outcomes', 'health-related quality of life, hospital bed usage or health-care costs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0565959', 'cui_str': 'New episode'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0336603', 'cui_str': 'Hospital bed'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}]",,0.352849,"Health economic analyses showed no differences between groups in health-related quality of life, hospital bed usage or health-care costs.
","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Dennis', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Forbes', 'Affiliation': 'Health Research Institute, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'Graham', 'Affiliation': 'Edinburgh Clinical Research Facility, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Maree', 'Initials': 'M', 'LastName': 'Hackett', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Graeme J', 'Initials': 'GJ', 'LastName': 'Hankey', 'Affiliation': 'Medical School, University of Western Australia, Crawley, WA, Australia.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'House', 'Affiliation': 'Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Lewis', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Lundström', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sandercock', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Mead', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24220']
3145,32454417,Induction chemotherapy followed by cisplatin or cetuximab concomitant to radiotherapy for laryngeal/hypopharyngeal cancer: Long-term results of the TREMPLIN randomised GORTEC trial.,"BACKGROUND


In Europe, induction chemotherapy (ICT) followed by radiotherapy is preferred to conventional chemoradiotherapy to avoid total laryngectomy in patients with laryngeal/hypopharyngeal cancer. In comparison with conventional radiotherapy, bioradiotherapy with cetuximab significantly improves locoregional control rates (LCRs) and overall survival (OS) without any increase in unmanageable toxicity.
METHODS


Patients included had untreated non-metastatic stage III-IV laryngeal/hypopharyngeal invasive squamous cell carcinoma. Good responders after three cycles of docetaxel-cisplatin-5-fluorouracil (TPF)-ICT (docetaxel and cisplatin, 75 mg/m 2  each on day 1, and 5-fluorouracil, 750 mg/m 2 /day on days 1-5) every 3 weeks were randomised to receive radiotherapy (70 Gy) with concurrent cisplatin (100 mg/m 2 /day on days 1, 22 and 43 of radiotherapy) or cetuximab (400 mg/m 2  of loading dose, 250 mg/m 2 /week during radiotherapy). The primary end-point was larynx preservation. The secondary end-points were laryngo-oesophageal dysfunction-free survival (LEDFS), LCR and OS.
RESULTS


A total of 153 patients were enrolled. Among 126 TPF-ICT responders, 116 were randomised to receive either cisplatin (n = 60) or cetuximab (n = 56). The median follow-up was 77.5 months. Five-year OS rates were 66.6% (95% confidence interval [CI]: 0.54-0.79) versus 66.9% (95% CI: 0.54-0.79) (p = 0.9), respectively. Five-year LCRs were 79.8% (95% CI: 69.5-90.0) versus 67.8% (95% CI: 55.1-80.5%) (p = 0.18). Five-year LEDFS was 62.2% (95% CI: 49.7-74.8%) versus 56.2% (95% CI: 43.0-69.4) (p = 0.38). Late grade III/IV salivary gland and laryngeal toxicity occurred in 10.3% versus 9.8% and 6.8% versus 11.8% of patients receiving cisplatin-radiotherapy versus cetuximab, respectively.
CONCLUSIONS


No significant difference in LEDFS was observed between the two arms. TPF-ICT followed by conventional chemoradiotherapy or cetuximab was feasible, and long-term toxicity was not statistically different between the two arms. LEDFS appears as a relevant end-point.",2020,"In comparison with conventional radiotherapy, bioradiotherapy with cetuximab significantly improves locoregional control rates (LCRs) and overall survival (OS) without any increase in unmanageable toxicity.
","['Patients included had untreated non-metastatic stage III-IV laryngeal/hypopharyngeal invasive squamous cell carcinoma', '126 TPF-ICT responders', 'laryngeal/hypopharyngeal cancer', '153 patients were enrolled', 'patients with laryngeal/hypopharyngeal cancer']","['radiotherapy (70\xa0Gy) with concurrent cisplatin', 'cisplatin-radiotherapy', 'radiotherapy', 'LEDFS', 'cetuximab', 'conventional chemoradiotherapy', 'induction chemotherapy (ICT', 'Induction chemotherapy followed by cisplatin or cetuximab concomitant to radiotherapy', 'cisplatin', 'conventional radiotherapy, bioradiotherapy with cetuximab', 'TPF)-ICT (docetaxel and cisplatin', '5-fluorouracil, 750\xa0mg/m 2', 'docetaxel-cisplatin-5-fluorouracil', 'TPF-ICT followed by conventional chemoradiotherapy or cetuximab']","['laryngo-oesophageal dysfunction-free survival (LEDFS), LCR\xa0and OS', 'LEDFS', 'locoregional control rates (LCRs) and overall survival (OS', 'larynx preservation', 'unmanageable toxicity', 'Late grade III/IV salivary gland and laryngeal toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0020629', 'cui_str': 'Hypopharyngeal structure'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0153398', 'cui_str': 'Malignant tumor of hypopharynx'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C4517868', 'cui_str': '750'}]","[{'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023051', 'cui_str': 'Disorder of the larynx'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0036098', 'cui_str': 'Salivary gland structure'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}]",153.0,0.178683,"In comparison with conventional radiotherapy, bioradiotherapy with cetuximab significantly improves locoregional control rates (LCRs) and overall survival (OS) without any increase in unmanageable toxicity.
","[{'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Janoray', 'Affiliation': 'Centre Hospitalier Régional et Universitaire, Henry Kaplan Center, Clinique D\'Oncologie et de Radiothérapie, Tours, France; Université François Rabelais de Tours, France; EA 7505, ""Education Ethique Santé"", EES, Tours, France. Electronic address: guillaume.janoray@yahoo.fr.'}, {'ForeName': 'Yoann', 'Initials': 'Y', 'LastName': 'Pointreau', 'Affiliation': ""Centre Hospitalier Régional et Universitaire, Henry Kaplan Center, Clinique D'Oncologie et de Radiothérapie, Tours, France.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Alfonsi', 'Affiliation': 'Clinique Sainte Catherine, Avignon, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sire', 'Affiliation': 'Centre Hospitalier de Lorient, Lorient, France.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Geoffrois', 'Affiliation': 'Institut de Cancérologie de Lorraine, Vandoeuvre Lès Nancy, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'de Raucourt', 'Affiliation': 'Centre François Baclesse, Caen, France.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Bardet', 'Affiliation': 'Centre René Gauducheau, Nantes, France.'}, {'ForeName': 'Marie-Hélène', 'Initials': 'MH', 'LastName': 'Calais', 'Affiliation': ""Centre Hospitalier Régional et Universitaire, Henry Kaplan Center, Clinique D'Oncologie et de Radiothérapie, Tours, France.""}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Garaud', 'Affiliation': ""Centre Hospitalier Régional et Universitaire, Henry Kaplan Center, Clinique D'Oncologie et de Radiothérapie, Tours, France.""}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Calais', 'Affiliation': ""Centre Hospitalier Régional et Universitaire, Henry Kaplan Center, Clinique D'Oncologie et de Radiothérapie, Tours, France; Université François Rabelais de Tours, France.""}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.04.009']
3146,32456097,Effects of a Rehabilitation Programme with a Nasal Inspiratory Restriction Device on Exercise Capacity and Quality of Life in COPD.,"OBJECTIVE


The objective was to assess the effects of a nasal restriction device for inspiratory muscle training, called Feelbreathe ® , added to a rehabilitation program (RP) on exercise capacity, quality of life, dyspnea and inspiratory muscle strength in patients with stable COPD.
METHODS


Patients were randomized into three groups, one performed a supervised RP using the Feelbreathe ®  device (FB group), the second group developed the same RP with oronasal breathing without FB (ONB group) and the third was the control group (CG). We evaluated inspiratory muscle strength (P Imax ), dyspnea (mMRC), quality of life (CAT) and exercise capacity (6MWT) before and after 8-week of RP.
RESULTS


A total of 16 patients completed the study, seven in FB group, five in ONB group and four in the CG. After the RP, the FB group showed a significant increase in P Imax  (93.3 ± 19.1 vs. 123.0 ± 15.8 mmHg) and in the 6MWT distance (462.9 ± 71.8m vs. 529.1 ± 50.1 m) and a decrease in the CAT score (9.7 ± 6.5 vs. 5.9 ± 6.0) and in the mMRC dyspnea score. FB provides greater improvement in P Imax , dyspnea, quality of life and 6MWT than ONB.
CONCLUSIONS


The Feelbreathe ®  device provides greater improvements in quality of life, dyspnea, exercise capacity and inspiratory muscle strength compared to patients that did not use it.",2020,"The Feelbreathe ®  device provides greater improvements in quality of life, dyspnea, exercise capacity and inspiratory muscle strength compared to patients that did not use it.","['16 patients completed the study, seven in FB group, five in ONB group and four in the CG', 'patients with stable COPD', 'Patients']","['nasal restriction device for inspiratory muscle training, called Feelbreathe ® , added to a rehabilitation program (RP', 'Rehabilitation Programme with a Nasal Inspiratory Restriction Device', 'supervised RP using the Feelbreathe ®  device (FB group), the second group developed the same RP with oronasal breathing without FB (ONB group) and the third was the control group (CG']","['CAT score', 'P Imax , dyspnea, quality of life and 6MWT', 'quality of life, dyspnea, exercise capacity and inspiratory muscle strength', 'Exercise Capacity and Quality of Life in COPD', 'mMRC dyspnea score', 'exercise capacity, quality of life, dyspnea and inspiratory muscle strength', 'P Imax', 'inspiratory muscle strength (P Imax ), dyspnea (mMRC), quality of life (CAT) and exercise capacity (6MWT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]",16.0,0.0239412,"The Feelbreathe ®  device provides greater improvements in quality of life, dyspnea, exercise capacity and inspiratory muscle strength compared to patients that did not use it.","[{'ForeName': 'Aurelio', 'Initials': 'A', 'LastName': 'Arnedillo', 'Affiliation': 'Pneumology, Allergy and Thoracic Surgery Department, University Hospital Puerta del Mar, 11009 Cádiz, Spain.'}, {'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'Gonzalez-Montesinos', 'Affiliation': 'GALENO Research Group, Department of Physical Education, Faculty of Education Sciences, University of Cádiz, 11003 Puerto Real, Spain.'}, {'ForeName': 'Jorge R', 'Initials': 'JR', 'LastName': 'Fernandez-Santos', 'Affiliation': 'GALENO Research Group, Department of Physical Education, Faculty of Education Sciences, University of Cádiz, 11003 Puerto Real, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Vaz-Pardal', 'Affiliation': 'Bahía Sur Andalusian Center for Sports Medicine, 11100 Cádiz, Spain.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'España-Domínguez', 'Affiliation': 'Pneumology, Allergy and Thoracic Surgery Department, University Hospital Puerta del Mar, 11009 Cádiz, Spain.'}, {'ForeName': 'Jesús G', 'Initials': 'JG', 'LastName': 'Ponce-González', 'Affiliation': 'Biomedical Research and Innovation Institute of Cádiz (INiBICA) Research Unit, Puerta del Mar University Hospital University of Cádiz, 11009 Cádiz, Spain.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Cuenca-García', 'Affiliation': 'GALENO Research Group, Department of Physical Education, Faculty of Education Sciences, University of Cádiz, 11003 Puerto Real, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17103669']
3147,32456130,Comparison of Chest Compression Quality Using Wing Boards versus Walking Next to a Moving Stretcher: A Randomized Crossover Simulation Study.,"BACKGROUND


When a rescuer walks alongside a stretcher and compresses the patient's chest, the rescuer produces low-quality chest compressions. We hypothesized that a stretcher equipped with wing boards allows for better chest compressions than the conventional method.
METHODS


In this prospective, randomized, crossover study, we enrolled 45 medical workers and students. They performed hands-on chest compressions to a mannequin on a moving stretcher, while either walking (the walk method) or riding on wings attached to the stretcher (the wing method). The depths of the chest compressions were recorded. The participants' vital signs were measured before and after the trials.
RESULTS


The average compression depth during the wing method (5.40 ± 0.50 cm) was greater than during the walk method (4.85 ± 0.80 cm;  p  < 0.01). The average compression rates during the two minutes were 215 ± 8 and 217 ± 5 compressions in the walk and wing methods, respectively ( p  = ns). Changes in blood pressure (14 ± 11 vs. 22 ± 14 mmHg), heart rate (32 ± 13 vs. 58 ± 20 bpm), and modified Borg scale (4 (interquartile range: 2-4) vs. 6 (5-7)) were significantly lower in the wing method cohort compared to the walking cohort ( p  < 0.01). The rescuer's size and physique were positively correlated with the chest compression depth during the walk method; however, we found no significant correlation in the wing method.
CONCLUSIONS


Chest compressions performed on the stretcher while moving using the wing method can produce high-quality chest compressions, especially for rescuers with a smaller size and physique.",2020,The average compression depth during the wing method (5.40 ± 0.50 cm) was greater than during the walk method (4.85 ± 0.80 cm;  p  < 0.01).,['enrolled 45 medical workers and students'],['Chest Compression Quality Using Wing Boards versus Walking Next to a Moving Stretcher'],"['chest compression depth', 'blood pressure', 'average compression depth', 'average compression rates', 'heart rate']","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0578671', 'cui_str': 'Does move'}, {'cui': 'C0150789', 'cui_str': 'Stretcher'}]","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",45.0,0.0202947,The average compression depth during the wing method (5.40 ± 0.50 cm) was greater than during the walk method (4.85 ± 0.80 cm;  p  < 0.01).,"[{'ForeName': 'Yukako', 'Initials': 'Y', 'LastName': 'Nakashima', 'Affiliation': 'Department of Emergency and Disaster Medicine, Hamamatsu University School of Medicine, Hamamatsu 431-3125, Japan.'}, {'ForeName': 'Takeji', 'Initials': 'T', 'LastName': 'Saitoh', 'Affiliation': 'Department of Emergency and Disaster Medicine, Hamamatsu University School of Medicine, Hamamatsu 431-3125, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Yasui', 'Affiliation': 'Department of Emergency and Disaster Medicine, Hamamatsu University School of Medicine, Hamamatsu 431-3125, Japan.'}, {'ForeName': 'Masahide', 'Initials': 'M', 'LastName': 'Ueno', 'Affiliation': 'Department of Emergency and Disaster Medicine, Hamamatsu University School of Medicine, Hamamatsu 431-3125, Japan.'}, {'ForeName': 'Kensuke', 'Initials': 'K', 'LastName': 'Hotta', 'Affiliation': 'Department of Emergency and Disaster Medicine, Hamamatsu University School of Medicine, Hamamatsu 431-3125, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ogawa', 'Affiliation': 'Department of Emergency and Disaster Medicine, Hamamatsu University School of Medicine, Hamamatsu 431-3125, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Department of Emergency and Disaster Medicine, Hamamatsu University School of Medicine, Hamamatsu 431-3125, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Maekawa', 'Affiliation': 'Department of Cardiology, Hamamatsu University School of Medicine, Hamamatsu 431-3125, Japan.'}, {'ForeName': 'Atsuto', 'Initials': 'A', 'LastName': 'Yoshino', 'Affiliation': 'Department of Emergency and Disaster Medicine, Hamamatsu University School of Medicine, Hamamatsu 431-3125, Japan.'}]",Journal of clinical medicine,['10.3390/jcm9051584']
3148,32460179,Preclinical profile and phase I clinical trial of a novel androgen receptor antagonist GT0918 in castration-resistant prostate cancer.,"PURPOSE


We conducted preclinical experiments and phase I clinical trial to investigate the safety, pharmacokinetics (PK) and antitumour effects of GT0918 in castration-resistant prostate cancer (CRPC).
EXPERIMENTAL DESIGN


An androgen receptor (AR) competitive binding assay was performed, followed by evaluation of GT0918 on AR protein expression. The efficacy of GT0918 was investigated in a castration-resistant xenograft model. A phase I dose-escalation study of GT0918 in CRPC was also carried out to evaluate its safety, PK and antitumour efficacy.
RESULTS


GT0918 was demonstrated to inhibit the binding of androgen to AR more potently than MDV3100, and to effectively reduce the AR protein level. GT0918 inhibited the transcriptional activity of wild-type AR and AR with clinically relevant ligand-binding domain mutations. Furthermore, GT0918 significantly inhibited the growth of prostate cancer. A total of 16 patients was treated with GT0918 at five dose levels. Among these 16 patients, 10 and 2 patients, respectively, completed a three-cycle and six-cycle treatment, in which MTD was not reached. All the treatment-related adverse events were grade I, including hypercholesterolemia, hypertriglyceridemia, fatigue and anaemia. PK parameters showed that drug exposure increased with dose proportionally from 50 to 300 mg and a saturation was observed between 300 and 400 mg. PSA declines of ≥30% and ≥50% were, respectively, observed in six and two cases. All the 12 patients with metastatic soft tissue lesions confirmed stable disease.
CONCLUSIONS


GT0918, a full AR antagonist without agonist effect, has high binding affinity to AR with AR protein down-regulation activity. GT0918 is demonstrated to be well tolerated with a favourable PK profile and exhibits promising antitumour activity in CRPC. CLINICALTRIALS: gov identifier CTR20150501.",2020,GT0918 is demonstrated to be well tolerated with a favourable PK profile and exhibits promising antitumour activity in CRPC.,"['castration-resistant prostate cancer (CRPC', 'castration-resistant prostate cancer', '12 patients with metastatic soft tissue lesions confirmed stable disease']",['novel androgen receptor antagonist GT0918'],"['safety, pharmacokinetics (PK) and antitumour effects', 'growth of prostate cancer', 'PSA declines', 'AR protein level', 'safety, PK\xa0and antitumour efficacy', 'transcriptional activity of wild-type AR and AR', 'hypercholesterolemia, hypertriglyceridemia, fatigue and anaemia']","[{'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0410013', 'cui_str': 'Soft tissue lesion'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C2936804', 'cui_str': 'Androgen Receptor Antagonists'}, {'cui': 'C4043276', 'cui_str': 'GT0918'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0034786', 'cui_str': 'Androgen receptor'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040649', 'cui_str': 'Genetic transcription'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",16.0,0.014045,GT0918 is demonstrated to be well tolerated with a favourable PK profile and exhibits promising antitumour activity in CRPC.,"[{'ForeName': 'Tie', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Suzhou Kintor Pharmaceuticals, Suzhou, Jiangsu, China.'}, {'ForeName': 'Honghua', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': 'Suzhou Kintor Pharmaceuticals, Suzhou, Jiangsu, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Fubo', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Qianxiang', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Suzhou Kintor Pharmaceuticals, Suzhou, Jiangsu, China.'}, {'ForeName': 'Jianguo', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Shancheng', 'Initials': 'S', 'LastName': 'Ren', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Chuanliang', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Suzhou Kintor Pharmaceuticals, Suzhou, Jiangsu, China.'}, {'ForeName': 'Meiyu', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Suzhou Kintor Pharmaceuticals, Suzhou, Jiangsu, China.'}, {'ForeName': 'Chunyun', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Suzhou Kintor Pharmaceuticals, Suzhou, Jiangsu, China. Electronic address: cychen@kintor.com.cn.'}, {'ForeName': 'Yinghao', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China. Electronic address: sunyhsmmu@126.com.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.04.013']
3149,32467558,Efficacy and Safety of Ureteral Catheter Use During Arteriovenous Fistula in End-Stage Renal Disease Patients with Poor Vascular Status.,"BACKGROUND The aim of this study was to evaluate the efficacy and safety of use of a ureteral catheter during arteriovenous fistula in end-stage renal disease patients with poor vascular status. MATERIAL AND METHODS Fifty patients with standard arteriovenous fistulas at Sir Run Run Hospital of Nanjing Medical University from April 2018 to April 2019 were included. Based on the use of ureteral catheter exploration and tourniquet hydraulic dilatation, patients were divided into study and control groups. The operative success rate, inner diameter of cephalic vein 1 day post-operatively, blood flow in the internal fistula, patency rate and blood flow in the internal fistula 3 months post-operatively, and complications 6 months post-operatively were compared between the 2 groups. RESULTS There were 25 cases in each group, with no significant differences in sex or age between the 2 groups. The operative success rate in the study group was higher than in the control group (96% vs. 88%) (F=1.087, P=0.297). The patency rates at 3 and 6 months post-operatively in the study group were higher than in the control group. The inner diameter of the cephalic vein 1 day post-operatively, the blood flow in the internal fistula, and the complications 6 months post-operatively in the study group were significantly superior to those of the control group (P=0.002). CONCLUSIONS In standard arteriovenous fistula, especially vascular catheter exploration of unhealthy vessels, the application of a ureteral catheter can improve the operative success rate and promote internal fistula maturity, with low cost and ease of use.",2020,The patency rates at 3 and 6 months post-operatively in the study group were higher than in the control group.,"['End-Stage Renal Disease Patients with Poor Vascular Status', 'end-stage renal disease patients with poor vascular status', 'Fifty patients with standard arteriovenous fistulas at Sir Run Run Hospital of Nanjing Medical University from April 2018 to April 2019 were included']","['ureteral catheter exploration and tourniquet hydraulic dilatation', 'ureteral catheter', 'Ureteral Catheter Use']","['Efficacy and Safety', 'operative success rate, inner diameter of cephalic vein 1 day post-operatively, blood flow in the internal fistula, patency rate and blood flow', 'patency rates', 'efficacy and safety', 'operative success rate', 'blood flow']","[{'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula'}, {'cui': 'C0242966', 'cui_str': 'Systemic inflammatory response syndrome'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0179799', 'cui_str': 'Ureteral catheter'}, {'cui': 'C1280903', 'cui_str': 'Exploration procedure'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0226802', 'cui_str': 'Structure of cephalic vein'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0333330', 'cui_str': 'Internal fistula'}, {'cui': 'C0175566', 'cui_str': 'Open'}]",50.0,0.0150771,The patency rates at 3 and 6 months post-operatively in the study group were higher than in the control group.,"[{'ForeName': 'Yongchao', 'Initials': 'Y', 'LastName': 'Fu', 'Affiliation': 'Kidney Disease Center, Sir Run Run Hospital, Nanjing Medical University, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Hongxia', 'Initials': 'H', 'LastName': 'Xing', 'Affiliation': 'Kidney Disease Center, Sir Run Run Hospital, Nanjing Medical University, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Wenwen', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Kidney Disease Center, Sir Run Run Hospital, Nanjing Medical University, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Changchun', 'Initials': 'C', 'LastName': 'Cao', 'Affiliation': 'Kidney Disease Center, Sir Run Run Hospital, Nanjing Medical University, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wan', 'Affiliation': 'Kidney Disease Center, Sir Run Run Hospital, Nanjing Medical University, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Feifei', 'Initials': 'F', 'LastName': 'Cao', 'Affiliation': 'Kidney Disease Center, Sir Run Run Hospital, Nanjing Medical University, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': 'Kidney Disease Center, Sir Run Run Hospital, Nanjing Medical University, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Shensen', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Kidney Disease Center, Sir Run Run Hospital, Nanjing Medical University, Nanjing, Jiangsu, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.920421']
3150,32467559,Outcomes with Tacrolimus-Based Immunosuppression After Kidney Transplantation from Standard- and Extended-Criteria Donors - A Post Hoc Analysis of the Prospective OSAKA Study.,"BACKGROUND This post hoc analysis of data from the prospective OSAKA study evaluated the efficacy and safety of prolonged- and immediate-release tacrolimus in patients who received kidneys from extended-criteria (ECD) and standard-criteria (SCD) donors. MATERIAL AND METHODS Within the ECD and SCD groups, patients were randomized to one of 4 tacrolimus-based regimens (initial dose): Arm 1, immediate-release tacrolimus (0.2 mg/kg/day); Arm 2, prolonged-release tacrolimus (0.2 mg/kg/day); Arm 3, prolonged-release tacrolimus (0.3 mg/kg/day); Arm 4, prolonged-release tacrolimus (0.2 mg/kg/day) plus basiliximab. All patients received mycophenolate mofetil and bolus corticosteroids; Arms 1-3 also received tapered corticosteroids. ECDs met the definition: living/deceased donors aged ≥60 years, or 50-60 years with ≥1 other risk factor, and donation after circulatory death. Primary composite endpoint: graft loss, biopsy-confirmed acute rejection or renal dysfunction by Day 168. Outcomes were compared across treatment arms with the chi-squared or Fisher's exact test. RESULTS A total of 1198 patients were included in the analysis (ECD: n=620 [51.8%], SCD: n=578 [48.2%]). Patients with kidneys from ECDs were older versus SCDs (mean age, 55.7 vs. 44.5 years, p<0.0001). A higher proportion of patients with kidneys from ECDs versus SCDs met the primary composite endpoint (56.8% vs. 32.4%, p<0.0001). However, no statistically significant differences in clinical outcomes or the incidence of treatment-emergent adverse events were seen between treatment arms within each donor group. CONCLUSIONS Worse outcomes were experienced in patients who received kidneys from ECDs versus SCDs. Prolonged-release tacrolimus provided similar graft survival to the immediate-release formulation, with a manageable tolerability profile.",2020,"However, no statistically significant differences in clinical outcomes or the incidence of treatment-emergent adverse events were seen between treatment arms within each donor group.","['After Kidney Transplantation from Standard- and Extended-Criteria Donors - A Post', 'A total of 1198 patients were included in the analysis (ECD: n=620 [51.8%], SCD: n=578 [48.2', 'Patients with kidneys from ECDs were older versus SCDs (mean age, 55.7 vs. 44.5 years, p<0.0001', 'patients who received kidneys from extended-criteria (ECD) and standard-criteria (SCD) donors', 'ECDs met the definition: living/deceased donors aged ≥60 years, or 50-60 years with ≥1 other risk factor, and donation after circulatory death']","['immediate-release tacrolimus', 'prolonged-release tacrolimus', 'tapered corticosteroids', 'Tacrolimus-Based Immunosuppression', 'prolonged- and immediate-release tacrolimus', 'tacrolimus', 'mycophenolate mofetil and bolus corticosteroids']","['efficacy and safety', 'clinical outcomes or the incidence of treatment-emergent adverse events', 'graft loss, biopsy-confirmed acute rejection or renal dysfunction', 'graft survival']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0014116', 'cui_str': 'Endocardial cushion defect'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C5191314', 'cui_str': '48.2'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C4049936', 'cui_str': 'Patient status determination, deceased and body donated'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0877042', 'cui_str': 'Graft loss'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}]",1198.0,0.117023,"However, no statistically significant differences in clinical outcomes or the incidence of treatment-emergent adverse events were seen between treatment arms within each donor group.","[{'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Albano', 'Affiliation': 'Department of Nephrology, University Hospital Center of Nice, Nice, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Banas', 'Affiliation': 'Department of Nephrology, University Medical Center Regensburg, Regensburg, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Lehner', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Glyda', 'Affiliation': 'Department of Transplantology and Surgery, District Public Hospital, Poznań, Poland.'}, {'ForeName': 'Ondrej', 'Initials': 'O', 'LastName': 'Viklicky', 'Affiliation': 'Department of Nephrology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schleibner', 'Affiliation': 'Formerly Astellas Pharma GmbH, Munich, Germany.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': 'Medical Affairs, Astellas Pharma Global Development, Inc., Northbrook, IL, USA.'}, {'ForeName': 'Nassim', 'Initials': 'N', 'LastName': 'Kamar', 'Affiliation': 'Department of Nephrology and Organ Transplantation, CHU Rangueil, Paul Sabatier University, INSERM U10403, Toulouse, France.'}]",Annals of transplantation,['10.12659/AOT.920041']
3151,32464527,Community-level interventions for pre-eclampsia (CLIP) in Mozambique: A cluster randomised controlled trial.,"OBJECTIVES


Pregnancy hypertension is the third leading cause of maternal mortality in Mozambique and contributes significantly to fetal and neonatal mortality. The objective of this trial was to assess whether task-sharing care might reduce adverse pregnancy outcomes related to delays in triage, transport, and treatment.
STUDY DESIGN


The Mozambique Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised controlled trial (NCT01911494) recruited pregnant women in 12 administrative posts (clusters) in Maputo and Gaza Provinces. The CLIP intervention (6 clusters) consisted of community engagement, community health worker-provided mobile health-guided clinical assessment, initial treatment, and referral to facility either urgently (<4hrs) or non-urgently (<24hrs), dependent on algorithm-defined risk. Treatment effect was estimated by multi-level logistic regression modelling, adjusted for prognostically-significant baseline variables. Predefined secondary analyses included safety and evaluation of the intensity of CLIP contacts.
MAIN OUTCOME MEASURES


20% reduction in composite of maternal, fetal, and newborn mortality and major morbidity.
RESULTS


15,013 women (15,123 pregnancies) were recruited in intervention (N = 7930; 2·0% loss to follow-up (LTFU)) and control (N = 7190; 2·8% LTFU) clusters. The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40). Compared with intervention arm women without CLIP contacts, those with ≥8 contacts experienced fewer primary outcomes (aOR 0·79 (95% CI 0·63, 0·99); p = 0·041), primarily due to improved maternal outcomes (aOR 0·72 (95% CI 0·53, 0·97); p = 0·033).
INTERPRETATION


As generally implemented, the CLIP intervention did not improve pregnancy outcomes; community implementation of the WHO eight contact model may be beneficial.
FUNDING


The University of British Columbia (PRE-EMPT), a grantee of the Bill & Melinda Gates Foundation (OPP1017337).",2020,"The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40).","['pre-eclampsia (CLIP) in Mozambique', 'pregnant women in 12 administrative posts (clusters) in Maputo and Gaza Provinces', '15,013 women (15,123 pregnancies']","['CLIP intervention', 'task-sharing care', 'CLIP intervention (6 clusters) consisted of community engagement, community health worker-provided mobile health-guided clinical assessment, initial treatment, and referral to facility either urgently (<4hrs) or non-urgently', 'Community-level interventions', 'Mozambique Community-Level Interventions']","['maternal outcomes', 'composite of maternal, fetal, and newborn mortality and major morbidity', 'safety and evaluation of the intensity of CLIP contacts']","[{'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026655', 'cui_str': 'Mozambique'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1292785', 'cui_str': 'Administrative action'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0026655', 'cui_str': 'Mozambique'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]",15013.0,0.295538,"The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40).","[{'ForeName': 'Esperança', 'Initials': 'E', 'LastName': 'Sevene', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique. Electronic address: esperanca.sevene@manhica.net.'}, {'ForeName': 'Sumedha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Khátia', 'Initials': 'K', 'LastName': 'Munguambe', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique.'}, {'ForeName': 'Charfudin', 'Initials': 'C', 'LastName': 'Sacoor', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'Anifa', 'Initials': 'A', 'LastName': 'Vala', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'Salésio', 'Initials': 'S', 'LastName': 'Macuacua', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Direcção Provincial de Saúde, Ministério da Saúde, Av. Eduardo Mondlane n(o) 1008, CP 264 Maputo, Mozambique.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Boene', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mark Ansermino', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Orvalho', 'Initials': 'O', 'LastName': 'Augusto', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique.'}, {'ForeName': 'Cassimo', 'Initials': 'C', 'LastName': 'Bique', 'Affiliation': 'Departamento de Ginecologia e Obstetrícia, Hospital Central de Maputo, Av. Agostinho Neto n(o) 167, CP 1164 Maputo, Mozambique.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Dustin T', 'Initials': 'DT', 'LastName': 'Dunsmuir', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Eusébio', 'Initials': 'E', 'LastName': 'Macete', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Instituto Nacional de Saúde, Ministério da Saúde, Distrito de Marracuene, Estrada Nacional N(o) 1, Maputo, Mozambique.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Nathan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Payne', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Mohsin', 'Initials': 'M', 'LastName': 'Sidat', 'Affiliation': 'Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': 'Corssino', 'Initials': 'C', 'LastName': 'Tchavana', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'Domena K', 'Initials': 'DK', 'LastName': 'Tu', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vidler', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre for Global Child Health, Hospital for Sick Children, 525 University Avenue, Suite 702, Toronto M5G 2L3, Canada.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Magee', 'Affiliation': ""Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'von Dadelszen', 'Affiliation': ""Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pregnancy hypertension,['10.1016/j.preghy.2020.05.006']
3152,32464566,"Efficacy of the computer simulation-based, interactive communication education program for nursing students.","BACKGROUND


Simulation-based education using standardized patients or high fidelity patient simulators is resource-intensive and can be limited in its consistency and repeatability. Standardized, interactive, and effective computer simulation-based education programs that improve communication skills among nursing students are greatly needed.
OBJECTIVES


This study aimed to (1) compare the efficacy of a computer simulation-based, interactive communication education (ComEd) program and an attention control (AC) program on communication knowledge, learning self-efficacy, and communication efficacy at baseline and twice after the intervention (immediately after and two weeks after); and (2) assess the acceptability and satisfaction of the ComEd reported by the participants.
DESIGN


This study employed a mixed-method, randomized controlled design with repeated measures.
METHODS


Students were recruited from four nursing schools and randomly assigned to either the intervention or AC group. They received either the ComEd or AC program installed on a tablet PC or a desktop computer in the classrooms and completed a 15-item communication knowledge scale, 10-item learning self-efficacy scale, 22-item communication efficacy scale, and 14-item satisfaction scale. In addition, six open-ended questions were used to help participants reflect on their learning experiences and explore their satisfaction with the programs. The Generalized Estimating Equation (GEE) model was the main model employed to examine the effects of the ComEd program over time in comparison with the AC program, and the content analysis method was used for qualitative data.
RESULTS


In total, 131 nursing students (66 in ComEd and 65 in AC) completed the programs and 127 participated through the two-week follow-up test. Compared to the AC group, the ComEd group significantly improved communication knowledge, learning self-efficacy, and communication efficacy; these effects were maintained at two weeks. The ComEd program was well accepted by the participants.
CONCLUSIONS


The ComEd is a promising approach because it is highly accessible, consistent, and repeatable, and has positive learning effects.",2020,"Compared to the AC group, the ComEd group significantly improved communication knowledge, learning self-efficacy, and communication efficacy; these effects were maintained at two weeks.","['131 nursing students (66 in ComEd and 65 in AC) completed the programs and 127 participated through the two-week follow-up test', 'nursing students', 'Students were recruited from four nursing schools']","['computer simulation-based, interactive communication education (ComEd) program and an attention control (AC) program', 'computer simulation-based, interactive communication education program']","['communication skills', 'communication knowledge, learning self-efficacy, and communication efficacy', 'acceptability and satisfaction', '15-item communication knowledge scale, 10-item learning self-efficacy scale, 22-item communication efficacy scale, and 14-item satisfaction scale']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036380', 'cui_str': 'Nursing Schools'}]","[{'cui': 'C0009609', 'cui_str': 'Models, Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",131.0,0.0254637,"Compared to the AC group, the ComEd group significantly improved communication knowledge, learning self-efficacy, and communication efficacy; these effects were maintained at two weeks.","[{'ForeName': 'Heeseung', 'Initials': 'H', 'LastName': 'Choi', 'Affiliation': 'College of Nursing, Seoul National University, Seoul, Republic of Korea; College of Nursing & The Research Institute of Nursing Science, Seoul National University, Seoul, Republic of Korea. Electronic address: hchoi20@snu.ac.kr.'}, {'ForeName': 'Ujin', 'Initials': 'U', 'LastName': 'Lee', 'Affiliation': 'College of Nursing, Seoul National University, Seoul, Republic of Korea.'}, {'ForeName': 'Ye Seul', 'Initials': 'YS', 'LastName': 'Jeon', 'Affiliation': 'College of Nursing, Seoul National University, Seoul, Republic of Korea.'}, {'ForeName': 'Chanhee', 'Initials': 'C', 'LastName': 'Kim', 'Affiliation': 'College of Nursing, Dong-A University, Busan, Republic of Korea.'}]",Nurse education today,['10.1016/j.nedt.2020.104467']
3153,32455860,Impact of Meal Timing and Chronotype on Food Reward and Appetite Control in Young Adults.,"Early meal timing and chronotype are associated with lower BMI, but their impact on appetite is poorly understood. We examined the impact of meal timing and chronotype on appetite and food reward. Forty-four adults were divided into early (EC; Morningness-Eveningness Questionnaire (MEQ) score = 55 ± 5) or late chronotype (LC; MEQ score = 40 ± 6) and assessed for body mass index, habitual energy intake (EI; three-day online dietary record) and eating behavior traits from the Three-Factor Eating Questionnaire (TFEQ). Participants attended the laboratory after ≥3 h fast on two occasions for early (AM; 8-10 a.m.) and late (PM; 4-6 p.m.) counterbalanced testing sessions in a 2 × 2 design. Appetite ratings and food reward (validated diurnal Leeds Food Preference Questionnaire) were measured in response to a standardized test meal. LC was associated with higher BMI ( p  = 0.01), but not with EI or TFEQ. The composite appetite score was lower in AM than PM (M Δ = -5 (95% CI -10, -0.2) mm,  p  = 0.040). Perceived test meal fillingness was higher in AM than PM and EC compared to LC ( p  ≤ 0.038). Liking and wanting high-fat food were lower in AM than PM ( p  ≤ 0.004). The late chronotype was associated with greater desire for high-fat food ( p  = 0.006). To conclude, early meal timing and early chronotype are independently associated with smaller appetite and lower desire for high-fat food.",2020,Perceived test meal fillingness was higher in AM than PM and EC compared to LC ( p  ≤ 0.038).,"['Forty-four adults were divided into early (EC; Morningness-Eveningness Questionnaire (MEQ) score = 55 ± 5) or', 'Young Adults']","['late chronotype (LC; MEQ score = 40 ± 6) and assessed for body mass index, habitual energy intake (EI; three-day online dietary record) and eating behavior traits from the Three-Factor Eating Questionnaire (TFEQ', 'Meal Timing and Chronotype']","['Perceived test meal fillingness', 'Appetite ratings and food reward (validated diurnal Leeds Food Preference Questionnaire', 'composite appetite score', 'higher BMI', 'Liking and wanting high-fat food']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012157', 'cui_str': 'Dietary Records'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0449243', 'cui_str': 'Timing'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0016483', 'cui_str': 'Food Preferences'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0453819', 'cui_str': 'Fatty food'}]",44.0,0.024407,Perceived test meal fillingness was higher in AM than PM and EC compared to LC ( p  ≤ 0.038).,"[{'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Beaulieu', 'Affiliation': 'School of Psychology, University of Leeds, Leeds LS2 9JT, UK.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Oustric', 'Affiliation': 'School of Psychology, University of Leeds, Leeds LS2 9JT, UK.'}, {'ForeName': 'Shaea', 'Initials': 'S', 'LastName': 'Alkahtani', 'Affiliation': 'Department of Exercise Physiology, College of Sport Sciences and Physical Activity, King Saud University, Riyadh 11451, Saudi Arabia.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Alhussain', 'Affiliation': 'Department of Food Science and Nutrition, College of Food and Agricultural Sciences, King Saud University, Riyadh 11451, Saudi Arabia.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Pedersen', 'Affiliation': 'Steno Diabetes Center Copenhagen, DK-2028 Gentofte, Denmark.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Salling Quist', 'Affiliation': 'Steno Diabetes Center Copenhagen, DK-2028 Gentofte, Denmark.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Færch', 'Affiliation': 'Steno Diabetes Center Copenhagen, DK-2028 Gentofte, Denmark.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Finlayson', 'Affiliation': 'School of Psychology, University of Leeds, Leeds LS2 9JT, UK.'}]",Nutrients,['10.3390/nu12051506']
3154,32455866,Phytosterols Supplementation Reduces Endothelin-1 Plasma Concentration in Moderately Hypercholesterolemic Individuals Independently of Their Cholesterol-Lowering Properties.,"Experimental and clinical studies have demonstrated the effect of phytosterols (PS) on reducing plasma levels of cholesterol and LDL-c, but the effects of plant sterols beyond cholesterol-lowering are still questionable. Since inflammation and endothelial dysfunction are involved in the pathogenesis of atherosclerosis, this study aims to evaluate the effect of PS on biomarkers involved in atherosclerosis progression and whether these effects are independent of alterations in plasma LDL-c levels. Thirty-eight moderately hypercholesterolemic volunteers (58 ± 12 years; LDL-c ≥ 130 mg/dL) were randomly assigned to consume 400 mL/day of soy milk or soy milk + PS (1.6 g/day) for 4 weeks in a double-blind, placebo-controlled, cross-over study. Blood samples were collected and lipid profiles and biomarkers for inflammation and endothelial dysfunction determined. The results showed that PS treatment reduced endothelin-1 plasma concentration by 11% ( p  = 0.02) independently of variations in plasma levels of LDL-c. No alterations were observed regarding fibrinogen, IL-6, hs-CRP, SAA, TNFα, or VCAM-1 between placebo and PS-treated groups. Furthermore, PS reduced total plasma cholesterol concentration (-5,5%,  p  < 0.001), LDL-c (-6.4%,  p  < 0.05), triglycerides (-8.3%,  p  < 0.05), and apo B (-5.3%,  p  < 0.05), without changing HDL-c concentration ( p  > 0.05). Therefore, PS supplementation effectively lowers endothelin-1 independently of the reductions in plasma levels of LDL-c, contributing to the comprehension of the effect of plant sterols on endothelial function and prevention of cardiovascular diseases.",2020,"No alterations were observed regarding fibrinogen, IL-6, hs-CRP, SAA, TNFα, or VCAM-1 between placebo and PS-treated groups.","['Thirty-eight moderately hypercholesterolemic volunteers (58 ± 12 years', 'Moderately Hypercholesterolemic Individuals']","['Phytosterols Supplementation', 'consume 400 mL/day of soy milk or soy milk + PS', 'phytosterols (PS', 'placebo']","['triglycerides', 'total plasma cholesterol concentration', 'endothelial function and prevention of cardiovascular diseases', 'Endothelin-1 Plasma Concentration', 'fibrinogen, IL-6, hs-CRP, SAA, TNFα, or VCAM-1', 'endothelin-1 plasma concentration', 'LDL-c', 'LDL-c ≥']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0031866', 'cui_str': 'Phytosterols'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439446', 'cui_str': 'mL/24h'}, {'cui': 'C0452741', 'cui_str': 'Soya milk'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0858034', 'cui_str': 'Plasma cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0002723', 'cui_str': 'Serum amyloid A protein'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}]",38.0,0.151145,"No alterations were observed regarding fibrinogen, IL-6, hs-CRP, SAA, TNFα, or VCAM-1 between placebo and PS-treated groups.","[{'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Oliveira Godoy Ilha', 'Affiliation': 'Laboratorio de Lipides (LIM10), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo 01246-903, Brazil.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Sutti Nunes', 'Affiliation': 'Laboratorio de Lipides (LIM10), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo 01246-903, Brazil.'}, {'ForeName': 'Milessa', 'Initials': 'M', 'LastName': 'Silva Afonso', 'Affiliation': 'Laboratorio de Lipides (LIM10), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo 01246-903, Brazil.'}, {'ForeName': 'Edna', 'Initials': 'E', 'LastName': 'Regina Nakandakare', 'Affiliation': 'Laboratorio de Lipides (LIM10), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo 01246-903, Brazil.'}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': 'da Silva Ferreira', 'Affiliation': 'Laboratorio de Lipides (LIM10), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo 01246-903, Brazil.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'de Paula Assis Bombo', 'Affiliation': 'Laboratorio de Lipides (LIM10), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo 01246-903, Brazil.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Rodrigues Giorgi', 'Affiliation': 'Laboratory of Cellular and Molecular Endocrinology (LIM-25), Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo 01246-903, Brazil.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Marcondes Machado', 'Affiliation': 'Laboratorio de Lipides (LIM10), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo 01246-903, Brazil.'}, {'ForeName': 'Eder', 'Initials': 'E', 'LastName': 'Carlos Rocha Quintão', 'Affiliation': 'Laboratorio de Lipides (LIM10), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo 01246-903, Brazil.'}, {'ForeName': 'Ana Maria', 'Initials': 'AM', 'LastName': 'Lottenberg', 'Affiliation': 'Laboratorio de Lipides (LIM10), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo 01246-903, Brazil.'}]",Nutrients,['10.3390/nu12051507']
3155,32455947,Changes in Bone Marrow Fat upon Dietary-Induced Weight Loss.,"BACKGROUND


Bone marrow fat is implicated in metabolism, bone health and haematological diseases. Thus, this study aims to analyse the impact of moderate weight loss on bone marrow fat content (BMFC) in obese, healthy individuals.
METHODS


Data of the HELENA-Trial (Healthy nutrition and energy restriction as cancer prevention strategies: a randomized controlled intervention trial), a randomized controlled trial (RCT) among 137 non-smoking, overweight or obese participants, were analysed to quantify the Magnetic Resonance Imaging (MRI)-derived BMFC at baseline, after a 12-week dietary intervention phase, and after a 50-week follow-up. The study cohort was classified into quartiles based on changes in body weight between baseline and week 12. Changes in BMFC in respect of weight loss were analysed by linear mixed models. Spearman's coefficients were used to assess correlations between anthropometric parameters, blood biochemical markers, blood cells and BMFC.
RESULTS


Relative changes in BMFC from baseline to week 12 were 0.0 ± 0.2%, -3.2 ± 0.1%, -6.1 ± 0.2% and -11.5 ± 0.6% for Q1 to Q4. Across all four quartiles and for the two-group comparison, Q1 versus Q4, there was a significant difference ( p  < 0.05) for changes in BMFC. BMFC was not associated with blood cell counts and showed only weaker correlations (<0.3) with metabolic biomarkers.
CONCLUSION


Weight loss is associated with a decrease of BMFC. However, BMFC showed no stronger associations with inflammatory and metabolic biomarkers.",2020,"BMFC was not associated with blood cell counts and showed only weaker correlations (<0.3) with metabolic biomarkers.
","['obese, healthy individuals', '137 non-smoking, overweight or obese participants']",['BMFC'],"['blood cell counts', 'BMFC', 'body weight', 'bone marrow fat content (BMFC', 'weight loss', 'Magnetic Resonance Imaging (MRI)-derived BMFC', 'anthropometric parameters, blood biochemical markers, blood cells and BMFC']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]","[{'cui': 'C0005771', 'cui_str': 'Blood cell count'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0005773', 'cui_str': 'Blood cell'}]",137.0,0.0619532,"BMFC was not associated with blood cell counts and showed only weaker correlations (<0.3) with metabolic biomarkers.
","[{'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Spurny', 'Affiliation': 'Heidelberg University Hospital, Diagnostic and Interventional Radiology, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany.'}, {'ForeName': 'Yixin', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Heidelberg University Hospital, Diagnostic and Interventional Radiology, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany.'}, {'ForeName': 'Solomon A', 'Initials': 'SA', 'LastName': 'Sowah', 'Affiliation': 'German Cancer Research Center (DKFZ), Division of Cancer Epidemiology, Im Neuenheimer Feld 581, 69120 Heidelberg, Germany.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Schübel', 'Affiliation': 'Heidelberg University Hospital, Diagnostic and Interventional Radiology, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Nonnenmacher', 'Affiliation': 'Heidelberg University Hospital, Diagnostic and Interventional Radiology, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bertheau', 'Affiliation': 'Heidelberg University Hospital, Diagnostic and Interventional Radiology, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany.'}, {'ForeName': 'Romy', 'Initials': 'R', 'LastName': 'Kirsten', 'Affiliation': 'German Cancer Research Center (DKFZ), Division of Cancer Epidemiology, Im Neuenheimer Feld 581, 69120 Heidelberg, Germany.'}, {'ForeName': 'Theron', 'Initials': 'T', 'LastName': 'Johnson', 'Affiliation': 'German Cancer Research Center (DKFZ), Division of Cancer Epidemiology, Im Neuenheimer Feld 581, 69120 Heidelberg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Hillengass', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Elm & Carlton Streets, Buffalo, New York 14263, USA.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Schlett', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Hugstetter Straße 55, D-79106 Freiburg, Germany.'}, {'ForeName': 'Oyunbileg', 'Initials': 'O', 'LastName': 'von Stackelberg', 'Affiliation': 'Heidelberg University Hospital, Diagnostic and Interventional Radiology, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany.'}, {'ForeName': 'Cornelia M', 'Initials': 'CM', 'LastName': 'Ulrich', 'Affiliation': 'Huntsman Cancer Institute and Department of Population Health Sciences, University of Utah, 2000 Circle of Hope, Salt Lake City, UT 84112-5550, USA.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Kaaks', 'Affiliation': 'German Cancer Research Center (DKFZ), Division of Cancer Epidemiology, Im Neuenheimer Feld 581, 69120 Heidelberg, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Kauczor', 'Affiliation': 'Heidelberg University Hospital, Diagnostic and Interventional Radiology, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany.'}, {'ForeName': 'Tilman', 'Initials': 'T', 'LastName': 'Kühn', 'Affiliation': 'German Cancer Research Center (DKFZ), Division of Cancer Epidemiology, Im Neuenheimer Feld 581, 69120 Heidelberg, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Nattenmüller', 'Affiliation': 'Heidelberg University Hospital, Diagnostic and Interventional Radiology, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany.'}]",Nutrients,['10.3390/nu12051509']
3156,32462979,Early and sustained symptom improvement with umeclidinium/vilanterol  versus  monotherapy in COPD: a  post hoc  analysis of the EMAX randomised controlled trial.,"BACKGROUND


In chronic obstructive pulmonary disease (COPD), both the time needed for patients to gain symptom improvement with long-acting bronchodilator therapy and whether an early response is predictive of a sustained response is unknown. This study aimed to investigate how quickly meaningful symptom responses are seen in patients with COPD with bronchodilator therapy and whether these responses are sustained.
METHODS


Early MAXimisation of bronchodilation for improving COPD stability (EMAX) was a 24-week, double-blind, double-dummy, parallel-group trial that randomised patients to umeclidinium/vilanterol (UMEC/VI), umeclidinium or salmeterol. Daily Evaluating Respiratory Symptoms in COPD (E-RS:COPD) score and rescue salbutamol use were captured  via  an electronic diary and analysed initially in 4-weekly periods.  Post hoc  analyses assessed change from baseline in daily E-RS:COPD score and rescue medication use weekly (Weeks 1-8), and association between E-RS:COPD responder status at Weeks 1-4 and later time points.
RESULTS


In the intent-to-treat population ( n  = 2425), reductions from baseline in E-RS:COPD scores and rescue medication use were apparent from Day 2 with all treatments. Treatment differences for UMEC/VI  versus  either monotherapy plateaued by Week 4-8 and were sustained at Weeks 21-24; improvements were consistently greater with UMEC/VI. For all treatments, most patients (60-85%) retained their Weeks 1-4 E-RS:COPD responder/non-responder status at Weeks 21-24. Among patients receiving UMEC/VI who were E-RS:COPD responders at Weeks 1-4, 70% were responders at Weeks 21-24.
CONCLUSION


Patients with symptomatic COPD had greater potential for early symptom improvements with UMEC/VI  versus  either monotherapy. This benefit was generally maintained for 24 weeks. Early monitoring of treatment response can provide clinicians with an early indication of a patient's likely longer-term response to prescribed bronchodilator treatment and will facilitate appropriate early adjustments in care.
CLINICAL TRIAL REGISTRATION


NCT03034915, 2016-002513-22 (EudraCT Number).  The reviews of this paper are available via the supplemental material section.",2020,Treatment differences for UMEC/VI  versus  either monotherapy plateaued by Week 4-8 and were sustained at Weeks 21-24; improvements were consistently greater with UMEC/VI.,"['chronic obstructive pulmonary disease (COPD', 'COPD', '2016-002513-22 (EudraCT Number', 'patients with COPD with']","['umeclidinium/vilanterol  versus  monotherapy', 'E-RS:COPD', 'bronchodilator therapy', 'EMAX', 'umeclidinium/vilanterol (UMEC/VI), umeclidinium or salmeterol']","['daily E-RS:COPD score and rescue medication', 'COPD stability']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0578554', 'cui_str': 'Inhaled bronchodilator therapy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C3661274', 'cui_str': 'umeclidinium'}, {'cui': 'C0073992', 'cui_str': 'salmeterol'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",,0.52709,Treatment differences for UMEC/VI  versus  either monotherapy plateaued by Week 4-8 and were sustained at Weeks 21-24; improvements were consistently greater with UMEC/VI.,"[{'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Kerwin', 'Affiliation': 'Crisor LLC, Clinical Research Institute, 3860 Crater Lake Ave., Medford, OR 97504, USA.'}, {'ForeName': 'Isabelle H', 'Initials': 'IH', 'LastName': 'Boucot', 'Affiliation': 'GSK, Brentford, Middlesex, UK.'}, {'ForeName': 'Claus F', 'Initials': 'CF', 'LastName': 'Vogelmeier', 'Affiliation': 'Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps-Universität Marburg, Member of the German Center for Lung Research (DZL), Germany.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Maltais', 'Affiliation': 'Centre de Pneumologie, Institut Universitaire de Cardiologie et de Pneumologie de Québec, Université Laval, Québec City, Québec, Canada.'}, {'ForeName': 'Ian P', 'Initials': 'IP', 'LastName': 'Naya', 'Affiliation': 'GSK, Brentford, Middlesex, UK.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Tombs', 'Affiliation': 'Precise Approach Ltd, contingent worker on assignment at GSK, Stockley Park West, Uxbridge, Middlesex, UK.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Jones', 'Affiliation': 'GSK, Brentford, Middlesex, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'Respiratory Clinical Sciences, GSK, Collegeville, PA, USA and Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Keeley', 'Affiliation': 'GSK, Stockley Park West, Uxbridge, Middlesex, UK.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Bjermer', 'Affiliation': 'Respiratory Medicine and Allergology, Lund University, Lund, Sweden.'}]",Therapeutic advances in respiratory disease,['10.1177/1753466620926949']
3157,32459637,Evaluating Safety and Efficacy of Follow-up for Patients With Abdominal Pain Using Video Consultation (SAVED Study): Randomized Controlled Trial.,"BACKGROUND


The benefits of telemedicine include cost savings and decentralized care. Video consultation is one form that enables early detection of deteriorating patients and promotion of self-efficacy in patients who are well but anxious. Abdominal pain is a common symptom presented by patients in emergency departments. These patients could benefit from video consultation, as it enables remote follow-up of patients who do not require admission and facilitates early discharge of patients from overcrowded hospitals.
OBJECTIVE


The study aimed to evaluate the safety and efficacy of the use of digital telereview in patients presenting with undifferentiated acute abdominal pain.
METHODS


The SAVED study was a prospective randomized controlled trial in which follow-up using existing telephone-based telereview (control) was compared with digital telereview (intervention). Patients with undifferentiated acute abdominal pain discharged from the emergency department observation ward were studied based on intention-to-treat. The control arm received routine, provider-scheduled telereview with missed reviews actively coordinated and rescheduled by emergency department staff. The intervention arm received access to a platform for digital telereview (asynchronous and synchronous format) that enabled patient-led appointment rescheduling. Patients were followed-up for 2 weeks for outcomes of service utilization, efficacy (compliance with their disposition plan), and safety (re-presentation for the same condition).
RESULTS


A total of 70 patients participated, with patients randomly assigned to each arm (1:1 ratio). Patients were a mean age of 40.0 (SD 13.8; range 22-71) years, predominantly female (47/70, 67%), and predominantly of Chinese ethnicity (39/70, 56%). The telereview service was used by 32 patients in the control arm (32/35, 91%) and 18 patients in the intervention arm (18/35, 51%). Most patients in control (33/35, 94%; 95% CI 79.5%-99.0%) and intervention (34/35, 97%; 95% CI 83.4%-99.9%) arms were compliant with their final disposition. There was a low rate of re-presentation at 72 hours and 2 weeks for both control (72 hours: 2/35, 6%; 95% CI 1.0%-20.5%; 2 weeks: 2/35, 6%, 95% CI 1.0%-20.5%) and intervention (72 hours: 2/35, 6%; 95% CI 1.0%-20.5%; 2 weeks: 3/35, 9%, 95% CI 2.2%-24.2%) arms. There were no significant differences in safety (P>.99) and efficacy (P>.99) between the two groups.
CONCLUSIONS


The application of digital telereview for the follow-up of patients with abdominal pain may be safe and effective. Future studies are needed to evaluate its cost-effectiveness and usefulness for broader clinical application.
TRIAL REGISTRATION


ISRCTN Registry ISRCTN28468556; http://www.isrctn.com/ISRCTN28468556.",2020,"Most patients in control (33/35, 94%; 95% CI 79.5%-99.0%) and intervention (34/35, 97%; 95% CI 83.4%-99.9%) arms were compliant with their final disposition.","['strong>Methods</strong', 'CLINICALTRIAL\n\n\nSingHealth Singapore General Hospital (2017/2049', 'patients presenting with undifferentiated acute abdominal pain', 'Patients With Abdominal Pain Using Video Consultation', 'Patients were a mean age of 40.0 (SD 13.8; range 22-71) years, predominantly female (47/70, 67%), and predominantly of Chinese ethnicity (39/70, 56', '70 patients participated', 'Patients with undifferentiated acute abdominal pain discharged from the emergency department observation ward were studied based on intention-to-treat']","['existing telephone-based telereview (control', 'digital telereview (intervention', 'digital telereview', 'routine, provider-scheduled telereview with missed reviews actively coordinated and rescheduled by emergency department staff', 'access to a platform for digital telereview (asynchronous and synchronous format) that enabled patient-led appointment rescheduling']","['Safety and Efficacy', 'telereview service', 'safety', 'safety and efficacy', 'low rate of re-presentation', 'Abdominal pain', 'service utilization, efficacy (compliance with their disposition plan), and safety (re-presentation for the same condition', 'efficacy']","[{'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205618', 'cui_str': 'Undifferentiated'}, {'cui': 'C0740577', 'cui_str': 'Acute abdominal pain'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517561', 'cui_str': '13.8'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0205541', 'cui_str': 'Rescheduled'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0439581', 'cui_str': 'Asynchronous'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C4704820', 'cui_str': 'Services Utilization'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",70.0,0.222931,"Most patients in control (33/35, 94%; 95% CI 79.5%-99.0%) and intervention (34/35, 97%; 95% CI 83.4%-99.9%) arms were compliant with their final disposition.","[{'ForeName': 'Dinesh Visva', 'Initials': 'DV', 'LastName': 'Gunasekeran', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Zhenghong', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Win Jim', 'Initials': 'WJ', 'LastName': 'Tan', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Koh', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Chiu Peng', 'Initials': 'CP', 'LastName': 'Cheong', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Lay Hong', 'Initials': 'LH', 'LastName': 'Tan', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Chee Siang', 'Initials': 'CS', 'LastName': 'Lau', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Gaik Kheng', 'Initials': 'GK', 'LastName': 'Phuah', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Newsie Donnah A', 'Initials': 'NDA', 'LastName': 'Manuel', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Che Chong', 'Initials': 'CC', 'LastName': 'Chia', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Gek Siang', 'Initials': 'GS', 'LastName': 'Seng', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Tong', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'May Hang', 'Initials': 'MH', 'LastName': 'Huin', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Suzette Villaluna', 'Initials': 'SV', 'LastName': 'Dulce', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Yap', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Kishanti', 'Initials': 'K', 'LastName': 'Ponampalam', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Ying', 'Affiliation': 'Health Services Research Center, Singhealth Services, Singapore, Singapore.'}, {'ForeName': 'Marcus Eng Hock', 'Initials': 'MEH', 'LastName': 'Ong', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ponampalam', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}]",Journal of medical Internet research,['10.2196/17417']
3158,32459639,"Achieving Optimal Gestational Weight Gain, Birth Weight, and Perinatal Outcomes Among Pregnant Women at Risk of Hypertension: Protocol for a Pilot Randomized Controlled Trial.","BACKGROUND


Hypertensive disorders, including preeclampsia, complicate 10% of all pregnancies, causing maternal and fetal morbidity and mortality. In Bangladesh, 24% of all maternal deaths are directly attributed to hypertensive disorders. Conventional antenatal care practices often delay or miss detecting hypertensive disorders in pregnancy, which may allow some women to become vulnerable to the adverse consequences of the hypertensive disorders. Regular self-monitoring of blood pressure and weight gain may improve maternal and fetal outcomes among pregnant women at risk of developing hypertensive disorders during pregnancy through early diagnosis, prompt referral, and timely clinical management; however, to undertake a randomized controlled trial of an intervention to reduce adverse consequences of hypertensive disorders in pregnancy, its feasibility must first be determined.
OBJECTIVE


The objectives of this study are to evaluate the accuracy of a wearable blood pressure monitoring device (Health Gauge) in order to test the design and methods of a future definitive randomized controlled trial, and to examine the feasibility, acceptability, and fidelity of an intervention focusing on regular monitoring of weight gain and self-monitoring of blood pressure for pregnant women at risk of developing hypertensive disorders and their associated complications.
METHODS


The study is located in Matlab, Bangladesh will be conducted in two phases. First, a wearable blood pressure device (Health Gauge) will be validated in accordance with the European Society of Hypertension International Protocol (revision 2010). Second, a prospective, two-arm, parallel, and nonblinded randomized controlled external pilot trial will be conducted. In the pilot trial, 70 eligible participants will be individually randomized to the intervention arm, in which pregnant women will self-monitor their blood pressure daily using a wearable device (Health Gauge) and be evaluated monthly by trained health workers for weight gain from 20 weeks of gestation until delivery, or the control arm, in which pregnant women will be assessed for weight gain every two months from 20 weeks of gestation until delivery (1:1 intervention to control allocation ratio using a permuted block randomization method with concealment). All women will receive standard antenatal care.
RESULTS


A validation study of the wearable blood pressure device has successfully been conducted among the general adult population in Matlab, Bangladesh. As of September 2019, the pilot trial has completed enrollment of women who are pregnant (N=70; intervention: n=35; control: n=35) and follow-up of the participants is ongoing. Data analysis is expected to be completed by June 2020, and results are expected to be submitted for publication in August 2020.
CONCLUSIONS


The findings of this study will help us to design a comprehensive, full-scale randomized controlled trial to test the efficacy of regular self-monitoring of blood pressure and weight gain during pregnancy, a simple and inexpensive intervention to help to achieve optimal maternal and fetal outcomes in pregnant women at risk of developing hypertensive disorders and their associated complications during pregnancy.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03858595; https://clinicaltrials.gov/ct2/show/NCT03858595.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/16676.",2020,"Regular self-monitoring of blood pressure (BP) and weight gain may optimize maternal and fetal outcomes among pregnant women at risk of developing HDP through early diagnosis, prompt referral, and timely clinical management.","['pregnant women at risk of developing HDP through early diagnosis, prompt referral, and timely clinical management', 'pregnant women at risk of developing HDP or their complications', 'Pregnant Women at Risk of Hypertension in Pregnancy by Regular Monitoring of Weight Gain and Blood Pressure', 'general adult population in Matlab', 'two phases in Matlab, Bangladesh: 1) validation of HG according to the European Society of Hypertension International Protocol revision 2010, and 2', '70 eligible participants']","['pregnant women will self-monitor their BP daily using a wearable device (HG) and be evaluated for weight gain monthly from 20 weeks of gestation until delivery or the control arm', 'Conventional antenatal care (ANC) practices', 'Regular self-monitoring of blood pressure (BP) and weight gain', 'wearable BP measuring device (Health Gauge [HG']","['weight gain', 'Optimizing Gestational Weight Gain, Birth Weight and Perinatal Outcomes']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C0596473', 'cui_str': 'Early Diagnosis'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0565599', 'cui_str': 'Maternal hypertension'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}]","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C4505348', 'cui_str': 'Wearable Technology'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1720302', 'cui_str': 'Until'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0456564', 'cui_str': 'Gauges'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",70.0,0.125868,"Regular self-monitoring of blood pressure (BP) and weight gain may optimize maternal and fetal outcomes among pregnant women at risk of developing HDP through early diagnosis, prompt referral, and timely clinical management.","[{'ForeName': 'S M Tafsir', 'Initials': 'SMT', 'LastName': 'Hasan', 'Affiliation': 'Nutrition and Clinical Services Division, icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Syed Imran', 'Initials': 'SI', 'LastName': 'Ahmed', 'Affiliation': 'Nutrition and Clinical Services Division, icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Md Alfazal', 'Initials': 'MA', 'LastName': 'Khan', 'Affiliation': 'Nutrition and Clinical Services Division, icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Shafiqul Alam', 'Initials': 'SA', 'LastName': 'Sarker', 'Affiliation': 'Nutrition and Clinical Services Division, icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Tahmeed', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'Nutrition and Clinical Services Division, icddr,b, Dhaka, Bangladesh.'}]",JMIR research protocols,['10.2196/16676']
3159,32460583,Acceptability of telehealth-delivered rehabilitation: Experiences and perspectives of people with traumatic brain injury and their carers.,"INTRODUCTION


Communication skills training for people with traumatic brain injury (TBI) and their carers is recommended best practice. Delivery via telehealth could improve access to this training. This paper focuses on the acceptability of telehealth delivery of communication skills training.
METHODS


A mixed-methods investigation of acceptability of telehealth to people with TBI and their carers was incorporated into a clinical trial. Thirty-six people with TBI (23 metropolitan and 13 regional) and their carers were recruited. Metropolitan participants were randomly allocated to telehealth or in-person intervention at a 1:3 ratio. Regional participants were allocated to telehealth. Telehealth and in-person participants were compared on retention, time to complete the programme, home practice completion and therapeutic alliance ratings. Participants completed semi-structured interviews regarding their views on telehealth, which were analysed using thematic analysis.
RESULTS


There were no significant differences between telehealth and in-person participants in retention rate, time to complete the programme, degree of home practice completion or therapeutic alliance ratings. Three themes were identified: 'telehealth delivery opens a window for access to rehabilitation in the context of my daily life', 'in-person delivery offers rehabilitation based on natural human interaction' and 'weighing telehealth against in-person delivery'.
DISCUSSION


Participants found telehealth delivery acceptable, as indicated by the similarity between groups in the quantitative process measures, and as reported in interviews. Some reported a preference for in-person delivery if there had been a choice of delivery mode. Participants described characteristics of the two delivery modes which were relevant to their attitudes towards telehealth.",2020,"There were no significant differences between telehealth and in-person participants in retention rate, time to complete the programme, degree of home practice completion or therapeutic alliance ratings.","['Metropolitan participants', 'Thirty-six people with TBI (23 metropolitan and 13 regional) and their carers were recruited', 'people with traumatic brain injury (TBI) and their carers', 'people with traumatic brain injury and their carers', 'people with TBI and their carers']","[""telehealth delivery opens a window for access to rehabilitation in the context of my daily life', 'in-person delivery offers rehabilitation based on natural human interaction' and 'weighing telehealth against in-person delivery"", 'Communication skills training', 'telehealth or in-person intervention', 'telehealth-delivered rehabilitation']","['retention rate, time to complete the programme, degree of home practice completion or therapeutic alliance ratings']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521124', 'cui_str': 'Against'}, {'cui': 'C0588407', 'cui_str': 'Communication skills training'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0814487', 'cui_str': 'Therapeutic Alliance'}]",36.0,0.0622804,"There were no significant differences between telehealth and in-person participants in retention rate, time to complete the programme, degree of home practice completion or therapeutic alliance ratings.","[{'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Rietdijk', 'Affiliation': 'The University of Sydney, Faculty of Medicine and Health, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Power', 'Affiliation': 'The University of Technology Sydney, Graduate School of Health, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Attard', 'Affiliation': 'The University of Sydney, Faculty of Medicine and Health, Australia.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Togher', 'Affiliation': 'The University of Sydney, Faculty of Medicine and Health, Australia.'}]",Journal of telemedicine and telecare,['10.1177/1357633X20923824']
3160,32466231,Taurine Supplementation Increases Post-Exercise Lipid Oxidation at Moderate Intensity in Fasted Healthy Males.,"Based on the fact that taurine can increase lipid metabolism, the objective of the present study was to evaluate the effects of different doses of acute taurine supplementation on lipid oxidation levels in healthy young men after a single bout of fasting aerobic exercise. A double-blind, acute, and crossover study design was conducted. Seventeen men (age 24.8 ± 4.07y; BMI: 23.9 ± 2.57 kg/m²) participated in the present study. Different doses of taurine (TAU) (3 g or 6 g) or placebo were supplemented 90 minutes before a single bout of fasting aerobic exercise (on a treadmill at 60% of VO2 max). The subjects performed three trials, and each one was separated by seven days. Blood samples were collected at baseline and after the exercise protocol of each test to analyze plasma levels of glycerol and taurine. Lipid and carbohydrate oxidation were determined immediately after exercise for 15 minutes by indirect calorimetry. We observed that TAU supplementation (6 g) increased lipid oxidation (38%) and reduced the respiratory coefficient (4%) when compared to the placebo ( p  < 0.05). However, no differences in lipid oxidation were observed between the different doses of taurine (3 g and 6 g). For glycerol concentrations, there were no differences between trials. Six grams of TAU supplementation 90 minutes before a single bout of aerobic exercise in a fasted state was sufficient to increase the lipid oxidation post-exercise in healthy young men.",2020,"However, no differences in lipid oxidation were observed between the different doses of taurine (3 g and 6 g).","['Seventeen men (age 24.8 ± 4.07y; BMI: 23.9 ± 2.57 kg/m²) participated in the present study', 'healthy young men after a single bout of fasting aerobic exercise', 'healthy young men', 'Fasted Healthy Males']","['taurine', 'Taurine Supplementation', 'taurine (TAU', 'acute taurine supplementation', 'fasting aerobic exercise', 'aerobic exercise', 'TAU supplementation', 'placebo']","['lipid oxidation levels', 'lipid oxidation post-exercise', 'lipid metabolism', 'Blood samples', 'respiratory coefficient', 'lipid oxidation', 'Lipid and carbohydrate oxidation']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0039350', 'cui_str': 'Taurine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}]",,0.193798,"However, no differences in lipid oxidation were observed between the different doses of taurine (3 g and 6 g).","[{'ForeName': 'Milena Barbon de', 'Initials': 'MB', 'LastName': 'Carvalho', 'Affiliation': 'Department of Food and Nutrition. School of Pharmaceutical Sciences of Araraquara. State University of São Paulo, Araraquara 14801-902, Brazil.'}, {'ForeName': 'Camila Fernanda Cunha', 'Initials': 'CFC', 'LastName': 'Brandao', 'Affiliation': 'Faculty of Physical Education, State University of Minas Gerais, Divinopolis 35501-170, Brazil.'}, {'ForeName': 'Priscila Giacomo', 'Initials': 'PG', 'LastName': 'Fassini', 'Affiliation': 'Ribeirao Preto Medical School. Department of Internal Medicine. University of Sao Paulo. Ribeirao Preto 14049-900, Brazil.'}, {'ForeName': 'Thiago Mantello', 'Initials': 'TM', 'LastName': 'Bianco', 'Affiliation': 'Ribeirao Preto Medical School. Department of Clinical Oncology, Stem Cells, and Cell Therapy. University of Sao Paulo, Ribeirao Preto 14040-907, Brazil.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Batitucci', 'Affiliation': 'Department of Food and Nutrition. School of Pharmaceutical Sciences of Araraquara. State University of São Paulo, Araraquara 14801-902, Brazil.'}, {'ForeName': 'Bryan Steve Martinez', 'Initials': 'BSM', 'LastName': 'Galan', 'Affiliation': 'Department of Food and Nutrition. School of Pharmaceutical Sciences of Araraquara. State University of São Paulo, Araraquara 14801-902, Brazil.'}, {'ForeName': 'Flávia Giolo', 'Initials': 'FG', 'LastName': 'De Carvalho', 'Affiliation': 'School of Physical Education and Sports of Ribeirao Preto University of São Paulo, Ribeirao Preto 14040-907, Brazil.'}, {'ForeName': 'Tales Sambrano', 'Initials': 'TS', 'LastName': 'Vieira', 'Affiliation': 'Department of Food and Nutrition. School of Pharmaceutical Sciences of Araraquara. State University of São Paulo, Araraquara 14801-902, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Ferriolli', 'Affiliation': 'Ribeirao Preto Medical School. Department of Internal Medicine. University of Sao Paulo. Ribeirao Preto 14049-900, Brazil.'}, {'ForeName': 'Julio Sergio', 'Initials': 'JS', 'LastName': 'Marchini', 'Affiliation': 'Ribeirao Preto Medical School. Department of Internal Medicine. University of Sao Paulo. Ribeirao Preto 14049-900, Brazil.'}, {'ForeName': 'Adelino Sanchez Ramos da', 'Initials': 'ASRD', 'LastName': 'Silva', 'Affiliation': 'School of Physical Education and Sports of Ribeirao Preto University of São Paulo, Ribeirao Preto 14040-907, Brazil.'}, {'ForeName': 'Ellen Cristini', 'Initials': 'EC', 'LastName': 'de Freitas', 'Affiliation': 'Department of Food and Nutrition. School of Pharmaceutical Sciences of Araraquara. State University of São Paulo, Araraquara 14801-902, Brazil.'}]",Nutrients,['10.3390/nu12051540']
3161,32469182,Trastuzumab Deruxtecan in Previously Treated HER2-Positive Gastric Cancer.,"BACKGROUND


Trastuzumab deruxtecan (DS-8201) is an antibody-drug conjugate consisting of an anti-HER2 (human epidermal growth factor receptor 2) antibody, a cleavable tetrapeptide-based linker, and a cytotoxic topoisomerase I inhibitor. The drug may have efficacy in patients with HER2-positive advanced gastric cancer.
METHODS


In an open-label, randomized, phase 2 trial, we evaluated trastuzumab deruxtecan as compared with chemotherapy in patients with HER2-positive advanced gastric cancer. Patients with centrally confirmed HER2-positive gastric or gastroesophageal junction adenocarcinoma that had progressed while they were receiving at least two previous therapies, including trastuzumab, were randomly assigned in a 2:1 ratio to receive trastuzumab deruxtecan (6.4 mg per kilogram of body weight every 3 weeks) or physician's choice of chemotherapy. The primary end point was the objective response, according to independent central review. Secondary end points included overall survival, response duration, progression-free survival, confirmed response (response persisting ≥4 weeks), and safety.
RESULTS


Of 187 treated patients, 125 received trastuzumab deruxtecan and 62 chemotherapy (55 received irinotecan and 7 paclitaxel). An objective response was reported in 51% of the patients in the trastuzumab deruxtecan group, as compared with 14% of those in the physician's choice group (P<0.001). Overall survival was longer with trastuzumab deruxtecan than with chemotherapy (median, 12.5 vs. 8.4 months; hazard ratio for death, 0.59; 95% confidence interval, 0.39 to 0.88; P = 0.01, which crossed the prespecified O'Brien-Fleming boundary [0.0202 on the basis of number of deaths]). The most common adverse events of grade 3 or higher were a decreased neutrophil count (in 51% of the trastuzumab deruxtecan group and 24% of the physician's choice group), anemia (38% and 23%, respectively), and decreased white-cell count (21% and 11%). A total of 12 patients had trastuzumab deruxtecan-related interstitial lung disease or pneumonitis (grade 1 or 2 in 9 patients and grade 3 or 4 in 3), as adjudicated by an independent committee. One drug-related death (due to pneumonia) was noted in the trastuzumab deruxtecan group; no drug-related deaths occurred in the physician's choice group.
CONCLUSIONS


Therapy with trastuzumab deruxtecan led to significant improvements in response and overall survival, as compared with standard therapies, among patients with HER2-positive gastric cancer. Myelosuppression and interstitial lung disease were the notable toxic effects. (Funded by Daiichi Sankyo; DESTINY-Gastric01 ClinicalTrials.gov number, NCT03329690.).",2020,"Overall survival was longer with trastuzumab deruxtecan than with chemotherapy (median, 12.5 vs. 8.4 months; hazard ratio for death, 0.59; 95% confidence interval, 0.39 to 0.88; P = 0.01, which crossed the prespecified O'Brien-Fleming boundary [0.0202 on the basis of number of deaths]).","['12 patients had trastuzumab deruxtecan-related interstitial lung disease or pneumonitis (grade 1 or 2 in 9 patients and grade 3 or 4 in 3), as adjudicated by an independent committee', 'patients with HER2-positive gastric cancer', 'patients with HER2-positive advanced gastric cancer', '187 treated patients', 'Previously Treated HER2-Positive Gastric Cancer', 'Patients with centrally confirmed HER2-positive gastric or gastroesophageal junction adenocarcinoma that had progressed while they were receiving at least two previous therapies, including']","['trastuzumab', 'trastuzumab deruxtecan', 'trastuzumab deruxtecan and 62 chemotherapy (55 received irinotecan and 7 paclitaxel', ""physician's choice of chemotherapy"", 'Trastuzumab Deruxtecan', 'chemotherapy']","['overall survival, response duration, progression-free survival, confirmed response (response persisting ≥4 weeks), and safety', 'neutrophil count', 'Overall survival', 'objective response', 'anemia', 'Myelosuppression and interstitial lung disease', 'white-cell count', 'response and overall survival']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C3714636', 'cui_str': 'Pneumonitis'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C1332166', 'cui_str': 'Adenocarcinoma of the gastroesophageal junction'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",187.0,0.240051,"Overall survival was longer with trastuzumab deruxtecan than with chemotherapy (median, 12.5 vs. 8.4 months; hazard ratio for death, 0.59; 95% confidence interval, 0.39 to 0.88; P = 0.01, which crossed the prespecified O'Brien-Fleming boundary [0.0202 on the basis of number of deaths]).","[{'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Shitara', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Yung-Jue', 'Initials': 'YJ', 'LastName': 'Bang', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Iwasa', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Naotoshi', 'Initials': 'N', 'LastName': 'Sugimoto', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Min-Hee', 'Initials': 'MH', 'LastName': 'Ryu', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sakai', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Hyun-Cheol', 'Initials': 'HC', 'LastName': 'Chung', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Hisato', 'Initials': 'H', 'LastName': 'Kawakami', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yabusaki', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Jeeyun', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Kaku', 'Initials': 'K', 'LastName': 'Saito', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Kawaguchi', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Kamio', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Akihito', 'Initials': 'A', 'LastName': 'Kojima', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Sugihara', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Kensei', 'Initials': 'K', 'LastName': 'Yamaguchi', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2004413']
3162,31301031,Prospective Longitudinal Trends in Body Composition and Clinical Outcomes 3 Years Following Sleeve Gastrectomy.,"BACKGROUND AND AIMS


Longitudinal assessment of body composition following bariatric surgery allows monitoring of health status. Our aim was to elucidate trends of anthropometric and clinical outcomes 3 years following sleeve gastrectomy (SG).
METHODS


A prospective cohort study of 60 patients who underwent SG. Anthropometrics including body composition analysis measured by multi-frequency bioelectrical impedance analysis, blood tests, liver fat content measured by abdominal ultrasound and habitual physical activity were evaluated at baseline and at 6 (M6), 12 (M12), and 36 (M36) months post-surgery.
RESULTS


Sixty patients (55% women, age 44.7 ± 8.7 years) who completed the entire follow-up were included. Fat mass (FM) was reduced significantly 1 year post-surgery (55.8 ± 11.3 to 26.7 ± 8.3 kg; P < 0.001) and then increased between 1 and 3 years post-operatively, but remained below baseline level (26.7 ± 8.3 to 33.1 ± 11.1 kg; P < 0.001). Fat free mass (FFM) decreased significantly during the first 6 months (64.7 ± 14.3 to 56.9 ± 11.8 kg; P < 0.001), slightly decreased between M6 and M12 and then reached a plateau through M36. Weight loss ""failure"" (< 50% excess weight loss) was noticed in 5.0% and 28.3% of patients at M12 and M36, respectively. Markers of lipid and glucose metabolism changed thereafter in parallel to the changes observed in FM, with the exception of HDL-C, which increased continuingly from M6 throughout the whole period analyzed (45.0 ± 10.2 to 59.5 ± 15.4 mg/dl; P < 0.001) and HbA1c which continued to decrease between M12 and M36 (5.5 ± 0.4 to 5.3 ± 0.4%; P < 0.001). There were marked within-person variations in trends of anthropometric and clinical parameters during the 3-year follow-up.
CONCLUSIONS


Weight regain primarily attributed to FM with no further decrease in FFM occurs between 1 and 3 years post-SG. FM increase at mid-term may underlie the recurrence of metabolic risk factors and can govern clinical interventions.",2019,"Fat mass (FM) was reduced significantly 1 year post-surgery (55.8 ± 11.3 to 26.7 ± 8.3 kg; P < 0.001) and then increased between 1 and 3 years post-operatively, but remained below baseline level (26.7 ± 8.3 to 33.1 ± 11.1 kg; P < 0.001).","['Years', '60 patients who underwent SG', 'Sixty patients (55% women, age 44.7\u2009±\u20098.7\xa0years) who completed the entire follow-up were included']","['Sleeve Gastrectomy', 'sleeve gastrectomy (SG']","['Fat free mass', 'FFM', 'Weight loss ""failure', 'Anthropometrics including body composition analysis measured by multi-frequency bioelectrical impedance analysis, blood tests, liver fat content measured by abdominal ultrasound and habitual physical activity', 'Markers of lipid and glucose metabolism', 'Fat mass (FM']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517880', 'cui_str': '8.7'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}]","[{'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0162536', 'cui_str': 'Biolectric Impedance'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",60.0,0.0308344,"Fat mass (FM) was reduced significantly 1 year post-surgery (55.8 ± 11.3 to 26.7 ± 8.3 kg; P < 0.001) and then increased between 1 and 3 years post-operatively, but remained below baseline level (26.7 ± 8.3 to 33.1 ± 11.1 kg; P < 0.001).","[{'ForeName': 'Shiri', 'Initials': 'S', 'LastName': 'Sherf-Dagan', 'Affiliation': 'Department Gastroenterology, Tel-Aviv Medical Center, Tel Aviv, Israel. shirisherf@gmail.com.'}, {'ForeName': 'Shira', 'Initials': 'S', 'LastName': 'Zelber-Sagi', 'Affiliation': 'Department Gastroenterology, Tel-Aviv Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Assaf', 'Initials': 'A', 'LastName': 'Buch', 'Affiliation': 'Institute of Endocrinology, Metabolism and Hypertension, Tel-Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Bar', 'Affiliation': 'Department Gastroenterology, Tel-Aviv Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Webb', 'Affiliation': 'Department Gastroenterology, Tel-Aviv Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Nasser', 'Initials': 'N', 'LastName': 'Sakran', 'Affiliation': 'Israeli Center for Bariatric Surgery (ICBS), Assia Medical Group, Assuta Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Asnat', 'Initials': 'A', 'LastName': 'Raziel', 'Affiliation': 'Israeli Center for Bariatric Surgery (ICBS), Assia Medical Group, Assuta Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Goitein', 'Affiliation': 'Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Keidar', 'Affiliation': ""Department of General Surgery, Assuta Ashdod Public Hospital, The Ben-Gurion University, Be'er Sheva, Israel.""}, {'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Shibolet', 'Affiliation': 'Department Gastroenterology, Tel-Aviv Medical Center, Tel Aviv, Israel.'}]",Obesity surgery,['10.1007/s11695-019-04057-2']
3163,32473356,Blunting periprocedural myocardial necrosis: Rationale and design of the randomized ALPHEUS study.,"BACKGROUND


Clopidogrel associated with aspirin is the recommended treatment for patients undergoing elective percutaneous coronary intervention (PCI). Although severe PCI-related events are rare, evidence suggests that PCI-related myocardial infarction and myocardial injury are frequent complications that can impact the clinical prognosis of the patients. Antiplatelet therapy with a potent P2Y 12  receptor inhibitor such as ticagrelor may reduce periprocedural ischemic complications while maintaining a similar safety profile as compared with conventional dual antiplatelet therapy by aspirin and clopidogrel in this setting.
METHODS


Assessment of Loading with the P2Y 12  inhibitor ticagrelor or clopidogrel to Halt ischemic Events in patients Undergoing elective coronary Stenting (ALPHEUS) (NCT02617290) is an international, multicenter, randomized, parallel-group, open-label study in patients with stable coronary artery disease who are planned for an elective PCI. In total, 1,900 patients will be randomized before a planned PCI to a loading dose of ticagrelor 180 mg or a loading dose of clopidogrel (300 or 600 mg) in addition to aspirin. Patients will then receive a dual antiplatelet therapy with aspirin and ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily for 30 days. The primary ischemic end point is PCI-related myocardial infarction (myocardial infarction type 4a or 4b) or major myocardial injury within 48 hours (or at hospital discharge if earlier) after elective PCI/stent. Safety will be evaluated by major bleeding events (Bleeding Academic Research Consortium type 3 or 5) at 48 hours (or discharge if it occurs earlier).
CONCLUSION


ALPHEUS is the first properly sized trial comparing ticagrelor to clopidogrel in the setting of elective PCI and is especially designed to show a reduction in periprocedural events, a surrogate end point for mortality.",2020,The primary ischemic end point is PCI-related myocardial infarction (myocardial infarction type 4a or 4b) or major myocardial injury within 48 hours (or at hospital discharge if earlier) after elective PCI/stent.,"['patients Undergoing elective coronary Stenting (ALPHEUS) (NCT02617290', 'patients with stable coronary artery disease who are planned for an elective PCI', '1,900 patients', 'patients undergoing elective percutaneous coronary intervention (PCI']","['Loading with the P2Y 12  inhibitor ticagrelor or clopidogrel', 'ticagrelor 180 mg or a loading dose of clopidogrel', 'aspirin', 'aspirin and ticagrelor 90 mg twice daily or clopidogrel']","['PCI-related myocardial infarction (myocardial infarction type 4a or 4b) or major myocardial injury within 48 hours (or at hospital discharge if earlier', 'periprocedural ischemic complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C3163568', 'cui_str': 'Ticagrelor 90 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",1900.0,0.0455808,The primary ischemic end point is PCI-related myocardial infarction (myocardial infarction type 4a or 4b) or major myocardial injury within 48 hours (or at hospital discharge if earlier) after elective PCI/stent.,"[{'ForeName': 'Johanne', 'Initials': 'J', 'LastName': 'Silvain', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Cayla', 'Affiliation': 'Cardiology department, Nîmes university Hospital, Montpellier University, ACTION study group, Nîmes, France.'}, {'ForeName': 'Farzin', 'Initials': 'F', 'LastName': 'Beygui', 'Affiliation': 'CHU de Caen-Département de Cardiologie; Caen, France.'}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Range', 'Affiliation': 'CH de Chartres-Département de Cardiologie, Chartes, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Lattuca', 'Affiliation': 'Cardiology department, Nîmes university Hospital, Montpellier University, ACTION study group, Nîmes, France.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Collet', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France.'}, {'ForeName': 'Jean-Guillaume', 'Initials': 'JG', 'LastName': 'Dillinger', 'Affiliation': 'Department of Cardiology, Inserm U942, Lariboisière Hospital, Assistance Publique-Hôpitaux de Paris, University of Paris, Paris, France.'}, {'ForeName': 'Ziad', 'Initials': 'Z', 'LastName': 'Boueri', 'Affiliation': 'CH de Bastia-Département de Cardiologie, Bastia, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Brunel', 'Affiliation': 'Hôpital Privé Dijon Bourgogne-Cardiologie Interventionelle GCIDB VALMY, Dijon, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Pouillot', 'Affiliation': 'Clinique Sainte Clotilde, La Réunion-Département de Cardiologie, La Réunion, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Boccara', 'Affiliation': ""AP-HP, Hôpitaux de l'Est Parisien, Hôpital Saint-Antoine, Department of Cardiology, Sorbonne Université-INSERM UMR S_938, Centre de Recherche Saint-Antoine, Paris, France.""}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Christiaens', 'Affiliation': 'CHU de Poitiers-Service de Cardiologie, Poitiers, France.'}, {'ForeName': 'Jean-Noël', 'Initials': 'JN', 'LastName': 'Labeque', 'Affiliation': 'GCS de Cardiologie de la Côte Basque, CH Bayonne, Bayonne, France.'}, {'ForeName': 'Thibault', 'Initials': 'T', 'LastName': 'Lhermusier', 'Affiliation': 'CHU de Toulouse-Département de Cardiologie, Toulouse, France.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Georges', 'Affiliation': 'CH de Versailles-Service de Cardiologie, Hôpital A. Mignot, Le Chesnay, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bellemain-Appaix', 'Affiliation': ""CH d'Antibes Juan-Les-Pins-Département de Cardiologie, Antibes Juan-Les-Pins, France.""}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Le Breton', 'Affiliation': 'Univ Rennes, CHU Rennes, Inserm LTSI U1099, Rennes, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hauguel-Moreau', 'Affiliation': 'CHU Ambroise Paré (APHP), Université Versailles-Saint Quentin, ACTION study Group, INSERM-U1018 CESP, Boulogne, France-Service de Cardiologie.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Saint-Etienne', 'Affiliation': 'CHU Trousseau, Tours-Département de Cardiologie, Tours, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Caussin', 'Affiliation': 'Institut Mutualiste Montsouris-Département de Cardiologie, Paris, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Jourda', 'Affiliation': 'CH Auxerre-Département de Cardiologie, Auxerre, France.'}, {'ForeName': 'Zuzana', 'Initials': 'Z', 'LastName': 'Motovska', 'Affiliation': '3rd Faculty of Medicine, Charles University and Cardiocentre Kralovske Vinohrady, Prague, Czech Republic.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Guedeney', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'El Kasty', 'Affiliation': ""Grand Hôpital de l'Est Francilien site Marne-La-Vallée - Département de Cardiologie, Marne La Vallée, France.""}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Laredo', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France.'}, {'ForeName': 'Raphaëlle', 'Initials': 'R', 'LastName': 'Dumaine', 'Affiliation': 'Les Grands Prés Cardiac Rehabilitation center, Villeneuve St Denis, France.'}, {'ForeName': 'Grégory', 'Initials': 'G', 'LastName': 'Ducrocq', 'Affiliation': 'FACT (French Alliance for Cardiovascular Trials), DHU FIRE, Hôpital Bichat, AP-HP, Université de Paris, Inserm U-1148, Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vicaut', 'Affiliation': 'Unité de Recherche Clinique, ACTION Study Group, Hôpital Fernand Widal (AP-HP), Paris, France; SAMM - Statistique, Analyse et Modélisation Multidisciplinaire EA 4543, Université Paris 1 Panthéon Sorbonne, Paris, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France. Electronic address: gilles.montalescot@aphp.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.04.017']
3164,32473365,Central nervous system activities of extract Mangifera indica L.,"ETHNOBOTANICAL RELEVANCE


Leaves of Mangifera indica L. have folk-uses in tropical regions of the world as health teas, as a remedy for exhaustion and fatigue, as a vegetable, and as a medicine. Mangifera indica leaf extract (MLE) had previously been demonstrated to alter brain electrical activity in-vivo. The aim of the present series of studies was to investigate whether mangiferin, a major compound in leaves and in MLE, is responsible for the neurocognitive activity of MLE, and if the CNS activities of MLE have translational potential.
MATERIALS AND METHODS


MLE, tradename Zynamite, is produced by Nektium Pharma, Spain. Isolated mangiferin was tested in-vitro in radioligand binding and enzyme inhibition studies against 106 CNS targets. Changes in the electroencephalograms (EEG's) of MLE and mangiferin were recorded in-vivo from four brain regions. Two double blind randomized placebo-controlled crossover clinical trials were conducted, each with 16 subjects. At 90 min and at 60 min respectively, after oral intake of 500 mg MLE, EEG recordings, psychometric tests, mood state, and tolerability were studied.
RESULTS


Isolated mangiferin is a selective inhibitor of catechol-O-methyltransferase (COMT) with an IC50 of 1.1 μM, with no activity on the CNS targets of caffeine. Both mangiferin and MLE induce similar changes in long-term potentiation (LTP) in the hippocampus in-vitro, and induce a similar pattern of EEG changes in-vivo. In both translational clinical trials MLE was well tolerated, with no cardiovascular side-effects. In both studies MLE caused significant spectral changes in brain electrical activity in cortical regions during cognitive challenges, different to the attenuated spectral changes induced by caffeine. There were no significant changes in the psychometric tests other than reaction time for all groups. In the second study there was a trend to faster reaction time within group for MLE (p = 0.066) and the percentage improvement in reaction time for MLE compared to placebo was significant (p = 0.049). In the first study MLE improved all scores for Profile of Mood States (POMS), with the score for ""fatigue"" significantly improved (p = 0.015); in the second study the POMS score for ""dejection"" was improved in the caffeine group, p = 0.05.
CONCLUSIONS


Mangiferin is a COMT inhibitor of moderate potency and is the major CNS-active compound in MLE. Both mangiferin and MLE increase hippocampal LTP in-vitro, and induce a similar pattern of changes in brain electrical activity in-vivo. While the translational clinical trials of MLE are limited by being single dose studies in a small number of subjects, they provide the first clinical evidence that the extract is well tolerated with no cardiovascular side-effects, can induce changes in brain electrical activity, may give a faster reaction time, and decrease fatigue. These CNS activities support the reported folk-uses use of mango leaf tea as a substitute for tea and as a traditional remedy for fatigue and exhaustion. Extract Mangifera indica L., Zynamite, has nootropic potential, and larger clinical studies are needed to realise this potential.",2020,"Both mangiferin and MLE induce similar changes in long term potentiation (LTP) in the hippocampus in-vitro, and induce a similar pattern of EEG changes in-vivo.",['16 subjects'],"['Mangifera indica leaf extract (MLE', 'caffeine', 'mangiferin and MLE', 'MLE', 'extract Mangifera indica L', 'placebo']","['fatigue', 'POMS score for ""dejection', 'Profile of Mood States (POMS', 'brain electrical activity', 'psychometric tests, mood state, and tolerability', 'reaction time for MLE', 'faster reaction time']",[],"[{'cui': 'C4081111', 'cui_str': 'mango leaf extract'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0065654', 'cui_str': 'mangiferin'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0330955', 'cui_str': 'Mangifera indica'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0234388', 'cui_str': 'Electrical activity of brain'}, {'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C4081111', 'cui_str': 'mango leaf extract'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]",,0.0364453,"Both mangiferin and MLE induce similar changes in long term potentiation (LTP) in the hippocampus in-vitro, and induce a similar pattern of EEG changes in-vivo.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'López-Ríos', 'Affiliation': 'Department of Research, Development and Innovation, Nektium Pharma SL, 35118, Las Palmas de Gran Canaria, Spain. Electronic address: llopez@nektium.com.'}, {'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'Wiebe', 'Affiliation': 'Department of Research, Development and Innovation, Nektium Pharma SL, 35118, Las Palmas de Gran Canaria, Spain. Electronic address: jwiebe@nektium.com.'}, {'ForeName': 'Tanausú', 'Initials': 'T', 'LastName': 'Vega-Morales', 'Affiliation': 'Department of Research, Development and Innovation, Nektium Pharma SL, 35118, Las Palmas de Gran Canaria, Spain. Electronic address: tvega@nektium.com.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Gericke', 'Affiliation': 'Department of Research, Development and Innovation, Nektium Pharma SL, 35118, Las Palmas de Gran Canaria, Spain; Department of Botany and Plant Biotechnology, University of Johannesburg, Auckland Park, 2006, Johannesburg, South Africa. Electronic address: ngericke@nektium.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.112996']
3165,32473403,Testing a self-directed lifestyle intervention among veterans: The D-ELITE pragmatic clinical trial.,"Nearly half of Veterans have obesity, fueling chronic diseases. The Department of Veterans Affairs (VA) offers an evidence-based behavioral weight management intervention called MOVE!, mostly delivered through in-person group sessions. Few eligible Veterans participate due to factors like distance and preferences, mirroring barriers in the general population. Practical alternatives to standard in-person programs are needed to improve access and engagement. A self-directed lifestyle intervention called D-ELITE-delivered through pre-recorded videos by DVD or online streaming-previously efficacious in a general primary care population, may provide such an alternative. This pragmatic clinical trial will evaluate whether D-ELITE improves weight and general health status among Veterans with obesity, relative to VA usual care. The yearlong intervention includes one orientation by phone, supplemental lifestyle coaching primarily via technology-based messages, 12 DVD or online streaming sessions over 3 months, and continued self-directed weight management for months 4-12. Participants use MyFitnessPal.com or paper booklets for self-monitoring weight, diet, and physical activity. Follow-up assessments at 12 and 24 months are administered by mail or phone. The study hypothesis is that compared with usual care, D-ELITE will lead to greater improvements in 12-month weight loss, per VA electronic health records, and general physical health status, assessed using the self-reported SF-12 physical composite score. We will also explore D-ELITE's effects on secondary biometric (e.g., HbA1c) and intermediate (e.g., diet) outcomes, reach, and budget impact. If effective, D-ELITE will offer a potentially scalable, low-cost alternative to VA's existing weight loss interventions by mitigating barriers presented by distance and technology.",2020,"If effective, D-ELITE will offer a potentially scalable, low-cost alternative to VA's existing weight loss interventions by mitigating barriers presented by distance and technology.","['veterans', 'Veterans with obesity, relative to VA usual care']","['supplemental lifestyle coaching primarily via technology-based messages, 12 DVD or online streaming sessions', 'self-directed lifestyle intervention', 'self-directed lifestyle intervention called D-ELITE-delivered through pre-recorded videos by DVD or online streaming-previously efficacious']","['secondary biometric (e.g., HbA1c) and intermediate (e.g., diet) outcomes, reach, and budget impact', 'weight and general health status']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.02449,"If effective, D-ELITE will offer a potentially scalable, low-cost alternative to VA's existing weight loss interventions by mitigating barriers presented by distance and technology.","[{'ForeName': 'Katherine D', 'Initials': 'KD', 'LastName': 'Hoerster', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States; VA Puget Sound Healthcare System, Seattle Division, Mental Health Service, 1660 South Columbian Way (S-116), Seattle, WA 98108, United States; University of Washington, Department of Psychiatry and Behavioral Sciences, 1100 NE 45(th) Street, Suite 300, Seattle, WA 98105, United States. Electronic address: Katherine.Hoerster@va.gov.'}, {'ForeName': 'Margaret P', 'Initials': 'MP', 'LastName': 'Collins', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Margaret.Collins@va.gov.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Au', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States; University of Washington, Department of Medicine, 1959 NE Pacific St, Seattle, WA 98195, United States. Electronic address: David.Au@va.gov.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Lane', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Amber.Lane2@va.gov.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Epler', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Eric.Epler@va.gov.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'McDowell', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Jennifer.McDowell@va.gov.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Barón', 'Affiliation': 'Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, 13001 E. 17(th) Place, Aurora, CO 80045, United States. Electronic address: Anna.Baron@cuanschutz.edu.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rise', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Peter.Rise@va.gov.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Plumley', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Robert.Plumley@va.gov.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Tanya.Nguyen@va.gov.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Schooler', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Mary.Schooler@va.gov.'}, {'ForeName': 'Linnaea', 'Initials': 'L', 'LastName': 'Schuttner', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States; University of Washington, Department of Medicine, 1959 NE Pacific St, Seattle, WA 98195, United States. Electronic address: Linnaea.Schuttner@va.gov.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'University of Illinois at Chicago, Department of Medicine, 1747 W. Roosevelt Rd, Room 586 (MC 275), Chicago, IL 60608, United States. Electronic address: maj2015@uic.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106045']
3166,32475274,2020 Chitranjan S. Ranawat Award: Perioperative essential amino acid supplementation suppresses rectus femoris muscle atrophy and accelerates early functional recovery following total knee arthroplasty.,"AIMS


The aim of this study was to assess the effectiveness of perioperative essential amino acid (EAA) supplementation to prevent rectus femoris muscle atrophy and facilitate early recovery of function after total knee arthroplasty (TKA).
METHODS


The study involved 60 patients who underwent unilateral TKA for primary knee osteo-arthritis (OA). This was a double-blind, placebo-controlled, randomized control trial with patients randomly allocated to two groups, 30 patients each: the essential amino acid supplementation (9 g daily) and placebo (lactose powder, 9 g daily) groups. Supplementation and placebo were provided from one week before to two weeks after surgery. The area of the rectus femoris muscle were measured by ultrasound imaging one month before surgery and one, two, three, and four weeks postoperatively. The serum albumin level, a visual analogue knee pain score, and mobility were also measured at each time point. The time to recovery of activities of daily living (ADLs) was recorded. Postoperative nutrition and physiotherapy were identical in both groups.
RESULTS


The mean relative change from baseline was as follows for the amino acid group: 116% in rectus femoris muscle area (71% to 206%); 95% in serum albumin (80% to 115%) and 39% in VAS pain (0% to 100%) at four weeks after surgery. These values in the placebo group were: 97% in muscle area (68 to 155); 89% in serum albumin (71% to 100%) and 56% in VAS pain four weeks after surgery (0% to 100%). All changes were statistically significant (p < 0.05). The mean time to recovery of ADLs was shorter in the amino acid group compared with the placebo group (p = 0.005).
CONCLUSION


Perioperative essential amino acid supplementation prevents rectus femoris muscle atrophy and accelerates early functional recovery after TKA. Cite this article:  Bone Joint J  2020;102-B(6 Supple A):10-18.",2020,"The mean time to recovery of ADLs was shorter in the amino acid group compared with the placebo group (p = 0.005).
","['60 patients who underwent', 'total knee arthroplasty (TKA', 'total knee arthroplasty', 'patients randomly allocated to two groups, 30 patients each: the', '2020 Chitranjan S. Ranawat Award', 'for primary knee osteo-arthritis (OA']","['placebo (lactose powder', 'perioperative essential amino acid (EAA) supplementation', 'Perioperative essential amino acid supplementation', 'unilateral TKA', 'essential amino acid supplementation', 'placebo']","['serum albumin', 'serum albumin level, a visual analogue knee pain score, and mobility', 'Postoperative nutrition and physiotherapy', 'mean time to recovery of ADLs', 'time to recovery of activities of daily living (ADLs', 'VAS pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004446', 'cui_str': 'Awards'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022949', 'cui_str': 'Lactose'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0002525', 'cui_str': 'Essential amino acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0556083', 'cui_str': 'Essential amino acid supplementation'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",60.0,0.422198,"The mean time to recovery of ADLs was shorter in the amino acid group compared with the placebo group (p = 0.005).
","[{'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Ueyama', 'Affiliation': 'Department of Orthopaedic Surgery, Osaka City University Graduate School of Medicine, Osaka, Japan, Department of Orthopaedic Surgery, Tanabe Central Hospital, Wakayama, Japan.'}, {'ForeName': 'Narihiro', 'Initials': 'N', 'LastName': 'Kanemoto', 'Affiliation': 'Department of Orthopaedic Surgery, Tanabe Central Hospital, Wakayama, Japan.'}, {'ForeName': 'Yukihide', 'Initials': 'Y', 'LastName': 'Minoda', 'Affiliation': 'Department of Orthopaedic Surgery, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Taniguchi', 'Affiliation': 'Department of Orthopaedic Surgery, Tanabe Central Hospital, Wakayama, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Nakamura', 'Affiliation': 'Department of Orthopaedic Surgery, Osaka City University Graduate School of Medicine, Osaka, Japan.'}]",The bone & joint journal,['10.1302/0301-620X.102B6.BJJ-2019-1370.R1']
3167,32475277,Using pharmacogenetics to structure individual pain management protocols in total knee arthroplasty.,"AIMS


The purpose of this study was to use pharmacogenetics to determine the frequency of genetic variants in our total knee arthroplasty (TKA) patients that could affect postoperative pain medications. Pharmacogenetic testing evaluates patient DNA to determine if a drug is expected to have a normal clinical effect, heightened effect, or no effect at all on the patient. It also predicts whether patients are likely to experience side effects from medicine. We further sought to determine if changing the multimodal programme based on these results would improve pain control or reduce side effects.
METHODS


In this pilot study, buccal samples were collected from 31 primary TKA patients. Pharmacogenetics testing examined genetic variants in genes  OPRM1 ,  CYP1A2 ,  CYP2B6 ,  CYP2C19 ,  CYP3A4 ,  CYP2C9 , and  CYP2D6 . These genes affect the pharmacodynamics and pharmacokinetics of non-steroidal anti-inflammatory drugs and opioids. We examined the frequency of genetic variants to any of the medications we prescribed including celecoxib, hydrocodone, and tramadol. Patients were randomized to one of two groups: the control group received the standard postoperative pain regimen, and the study group received a customized regimen based on the pharmacogenetic results. For the first ten postoperative days, patients recorded pain scores, medication, and side effects.
RESULTS


Genetic variants involving one or more medications in the multimodal pain protocol occurred in 13 of the 31 patients (42%). In total, eight patients (26%) had variants affecting more than one of the medications. For the 25 patients who recorded pain and medication logs, the mean pain levels and morphine equivalents (MEQs) consumed in the first ten days were higher in the control group than in the custom-guided group (p = 0.019 for pain and p = 0.655 for MEQ).
CONCLUSION


Overall, 42% of patients had a variant involving one of the pain medications prescribed in our perioperative pain program for TKA. Ongoing research will help determine if using these data to modify a patient's medication will improve outcomes. Cite this article:  Bone Joint J  2020;102-B(6 Supple A):73-78.",2020,"Patients were randomized to one of two groups: the control group received the standard postoperative pain regimen, and the study group received a customized regimen based on the pharmacogenetic results.","['total knee arthroplasty', 'total knee arthroplasty (TKA) patients', '31 primary TKA patients']","['standard postoperative pain regimen', 'celecoxib, hydrocodone, and tramadol']","['postoperative pain medications', 'pain scores, medication, and side effects', 'multimodal pain protocol', 'mean pain levels and morphine equivalents (MEQs']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0020264', 'cui_str': 'Hydrocodone'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}]",8.0,0.0321511,"Patients were randomized to one of two groups: the control group received the standard postoperative pain regimen, and the study group received a customized regimen based on the pharmacogenetic results.","[{'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Hamilton', 'Affiliation': 'Anderson Orthopaedic Research Institute, Alexandria, Virginia, USA.'}, {'ForeName': 'Jeanine M', 'Initials': 'JM', 'LastName': 'Gargiulo', 'Affiliation': 'Anderson Orthopaedic Research Institute, Alexandria, Virginia, USA.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Parks', 'Affiliation': 'Anderson Orthopaedic Research Institute, Alexandria, Virginia, USA.'}]",The bone & joint journal,['10.1302/0301-620X.102B6.BJJ-2019-1539.R1']
3168,32475278,2020 Mark Coventry Award: Microorganism-directed oral antibiotics reduce the rate of failure due to further infection after two-stage revision hip or knee arthroplasty for chronic infection: a multicentre randomized controlled trial at a minimum of two years.,"AIMS


The aim of this study was to determine if a three-month course of microorganism-directed oral antibiotics reduces the rate of failure due to further infection following two-stage revision for chronic prosthetic joint infection (PJI) of the hip and knee.
METHODS


A total of 185 patients undergoing a two-stage revision in seven different centres were prospectively enrolled. Of these patients, 93 were randomized to receive microorganism-directed oral antibiotics for three months following reimplantation; 88 were randomized to receive no antibiotics, and four were withdrawn before randomization. Of the 181 randomized patients, 28 were lost to follow-up, six died before two years follow-up, and five with culture negative infections were excluded. The remaining 142 patients were followed for a mean of 3.3 years (2.0 to 7.6) with failure due to a further infection as the primary endpoint. Patients who were treated with antibiotics were also assessed for their adherence to the medication regime and for side effects to antibiotics.
RESULTS


Nine of 72 patients (12.5%) who received antibiotics failed due to further infection compared with 20 of 70 patients (28.6%) who did not receive antibiotics (p = 0.012). Five patients (6.9%) in the treatment group experienced adverse effects related to the administered antibiotics severe enough to warrant discontinuation.
CONCLUSION


This multicentre randomized controlled trial showed that a three-month course of microorganism-directed, oral antibiotics significantly reduced the rate of failure due to further infection following a two-stage revision of total hip or knee arthroplasty for chronic PJI. Cite this article:  Bone Joint J  2020;102-B(6 Supple A):3-9.",2020,"RESULTS


Nine of 72 patients (12.5%) who received antibiotics failed due to further infection compared with 20 of 70 patients (28.6%) who did not receive antibiotics (p = 0.012).","['185 patients undergoing a two-stage revision in seven different centres were prospectively enrolled', 'two-stage revision for chronic prosthetic joint infection (PJI) of the hip and knee', '181 randomized patients, 28 were lost to follow-up, six died before two years follow-up, and five with culture negative infections were excluded', '2020 Mark Coventry Award', 'The remaining 142 patients were followed for a mean of 3.3 years (2.0 to 7.6) with failure due to a further infection as the primary endpoint']","['no antibiotics', 'microorganism-directed, oral antibiotics', 'Microorganism-directed oral antibiotics', 'microorganism-directed oral antibiotics']","['adverse effects', 'rate of failure', 'antibiotics failed due to further infection']","[{'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439619', 'cui_str': 'Two stage revision'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0410808', 'cui_str': 'Prosthetic joint infection'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0855652', 'cui_str': 'Culture negative'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0004446', 'cui_str': 'Awards'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517688', 'cui_str': '3.3'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",185.0,0.130337,"RESULTS


Nine of 72 patients (12.5%) who received antibiotics failed due to further infection compared with 20 of 70 patients (28.6%) who did not receive antibiotics (p = 0.012).","[{'ForeName': 'JaeWon', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Parvizi', 'Affiliation': 'Department of Orthopaedic Surgery, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Erik N', 'Initials': 'EN', 'LastName': 'Hansen', 'Affiliation': 'Department of Orthopaedic Surgery, University of California San Francisco Medical Center, San Francisco, California, USA.'}, {'ForeName': 'Chris N', 'Initials': 'CN', 'LastName': 'Culvern', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Segreti', 'Affiliation': 'Department of Internal Medicine, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Tan', 'Affiliation': 'Department of Orthopaedic Surgery, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Curtis W', 'Initials': 'CW', 'LastName': 'Hartman', 'Affiliation': 'Department of Orthopaedic Surgery, University of Nebraska Medical Center, Omaha, Nebraska, USA.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Sporer', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Della Valle', 'Affiliation': 'Division of Adult Reconstruction, Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The bone & joint journal,['10.1302/0301-620X.102B6.BJJ-2019-1596.R1']
3169,32456236,"A Lifestyle (Dietary) Intervention Reduces Tiredness in Children with Subclinical Hypothyroidism, a Randomized Controlled Trial.","PURPOSE


Subclinical hypothyroidism (SH) in children and adults is a subject for discussion in terms of whether to treat it or not with respect to the short-term clinical implications and consequences of SH and in the long term. If treatment with thyroxine supplementation is not indicated, no other treatment is available. We investigated whether a lifestyle (dietary) intervention improves or normalizes SH or decreases the presence of Thyroid Stimulating Hormone (TSH) and/or tiredness.  Methods : We randomized children aged 1-12 years with SH to the control group (standard care = no treatment) or intervention group (dietary intervention). The dietary intervention consisted of green vegetables, beef, whole milk and butter for 6 months. The rest of the diet remained unchanged. We measured TSH, FreeT4, Lipid profile, Body Mass Index (BMI) and Pediatric Quality of Life (PedQL) multidimensional fatigue scale scores.  Results : In total, 62 children were included. After 6 months, TSH decreased in both groups without a significant difference between the groups ( p  = 0.98). PedQL fatigue scores for sleep ( p  = 0.032) and total fatigue scores ( p  = 0.039) improved significantly in the intervention group, compared to the control group. No unfavorable effects occurred in the lipid profile or BMI.  Conclusion : The lifestyle (dietary) intervention did not normalize SH and TSH levels, but it significantly reduced tiredness. These results suggest that children's well-being can be improved without medication.",2020,"After 6 months, TSH decreased in both groups without a significant difference between the groups ( p  = 0.98).","['children and adults', '62 children were included', 'children aged 1-12 years with SH to the control group (standard care = no treatment) or', 'Children with Subclinical Hypothyroidism']","['dietary intervention consisted of green vegetables, beef, whole milk and butter for 6 months', 'A Lifestyle (Dietary) Intervention', 'thyroxine supplementation', 'intervention group (dietary intervention', 'lifestyle (dietary) intervention']","['Tiredness', 'Thyroid Stimulating Hormone (TSH) and/or tiredness', 'TSH', 'PedQL fatigue scores for sleep', 'normalize SH and TSH levels', 'lipid profile or BMI', 'total fatigue scores', 'tiredness', 'TSH, FreeT4, Lipid profile, Body Mass Index (BMI) and Pediatric Quality of Life (PedQL) multidimensional fatigue scale scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0271790', 'cui_str': 'Subclinical hypothyroidism'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0452849', 'cui_str': 'Beef'}, {'cui': 'C0452717', 'cui_str': 'Whole milk'}, {'cui': 'C0006494', 'cui_str': 'Butter'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0271790', 'cui_str': 'Subclinical hypothyroidism'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",62.0,0.037638,"After 6 months, TSH decreased in both groups without a significant difference between the groups ( p  = 0.98).","[{'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'van der Gaag', 'Affiliation': 'Department of Pediatrics, Hospital Group Twente, 7609 PP Almelo, The Netherlands.'}, {'ForeName': 'Job', 'Initials': 'J', 'LastName': 'van der Palen', 'Affiliation': 'Faculty of Behavioural, Management and Social Sciences (BMS), University of Twente, 7522 NB Enschede, The Netherlands.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Schaap', 'Affiliation': 'Department of Pediatrics, Hospital Group Twente, 7609 PP Almelo, The Netherlands.'}, {'ForeName': 'Mirthe', 'Initials': 'M', 'LastName': 'van Voorthuizen', 'Affiliation': 'Department of Pediatrics, Hospital Group Twente, 7609 PP Almelo, The Netherlands.'}, {'ForeName': 'Thalia', 'Initials': 'T', 'LastName': 'Hummel', 'Affiliation': 'Department of Pediatrics, Medical Centre Twente, 7512 KZ Enschede, The Netherlands.'}]",International journal of environmental research and public health,['10.3390/ijerph17103689']
3170,32456272,Optimizing the Interaction of Exercise Volume and Metformin to Induce a Clinically Significant Reduction in Metabolic Syndrome Severity: A Randomised Trial.,"Insulin resistance is a central mediating factor of the metabolic syndrome (MetS), with exercise training and metformin proven antidotes to insulin resistance. However, when the two therapies are combined there is conflicting data regarding whether metformin blunts or improves exercise training-induced adaptations. The volume of exercise (duration, intensity, and frequency) on the interaction of exercise training and metformin has yet to be investigated. The aim of this study is therefore to explore the impact of a combination of different exercise volumes and metformin on MetS severity. This is a secondary analysis of data from one of the sites of the 'Exercise in Prevention of Metabolic Syndrome' (EX-MET) study. Ninety-nine adults with MetS were randomized into a 16-week exercise program completing either: (i) moderate-intensity continuous training (MICT) at 60-70% of peak heart rate (HRpeak) for 30 min/session ( n  = 34, 150 min/week); (ii) high-volume high-intensity interval training (HIIT) consisting of 4 × 4 min bouts at 85-95% HRpeak, interspersed with 3 min of active recovery at 50-70% HRpeak ( n  = 34, 38 min/session, 114 min/week); or (iii) low volume HIIT, 1 × 4 min bout of HIIT at 85-95% HRpeak ( n  = 31, 17 min/session, 51 min/week). Metformin intake was monitored and recorded throughout the trial. MetS severity was calculated as z-scores derived from MetS risk factors assessed at pre- and post-intervention. Sixty-five participants had complete pre- and post-intervention data for MetS z-score, of which 18 participants (28%) were taking metformin. Over the 16-week intervention, a similar proportion of participants clinically improved MetS severity (Δ ≥ -0.87) with metformin (8/18, 44%) or without metformin (23/47, 49%) ( p  = 0.75). While there were no between-group differences ( p  = 0.24), in those who did not take metformin low-volume HIIT had more likely responders (10/15, 67%) compared to MICT (6/16, 38%) and high-volume HIIT (7/16, 44%). In those taking metformin, there was a lower proportion of participants who clinically improved MetS severity following high-volume HIIT (1/6, 17%) compared to MICT (2/4, 50%) and low-volume HIIT (5/8, 63%), but with no between-group difference ( p  = 0.23). Moreover, in those who performed high-volume HIIT, there was a statistically significantly higher proportion ( p  = 0.03) of likely non-responders with improved MetS severity in participants taking metformin (4/6, 67%) compared to those not taking metformin (3/16, 19%). In individuals with MetS, the effect of high volume HIIT on MetS severity may be blunted in those taking metformin. These findings need to be confirmed in a larger study.",2020,"Over the 16-week intervention, a similar proportion of participants clinically improved MetS severity (Δ ≥ -0.87) with metformin (8/18, 44%) or without metformin (23/47, 49%) ( p  = 0.75).","['Ninety-nine adults with MetS', 'Sixty-five participants had complete pre- and post-intervention data for MetS z-score, of which 18 participants (28%) were taking']","['exercise training and metformin', 'Metformin', 'metformin', 'exercise program completing either: (i) moderate-intensity continuous training (MICT', 'MICT', 'high-volume high-intensity interval training (HIIT) consisting of 4 × 4 min bouts at 85-95% HRpeak, interspersed with 3 min of active recovery at 50-70% HRpeak']","['MetS severity', 'volume of exercise (duration, intensity, and frequency']","[{'cui': 'C3828813', 'cui_str': '99'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",99.0,0.0481252,"Over the 16-week intervention, a similar proportion of participants clinically improved MetS severity (Δ ≥ -0.87) with metformin (8/18, 44%) or without metformin (23/47, 49%) ( p  = 0.75).","[{'ForeName': 'Joyce S', 'Initials': 'JS', 'LastName': 'Ramos', 'Affiliation': 'Caring Futures Institute & SHAPE Research Centre, Exercise Science and Clinical Exercise Physiology, College of Nursing and Health Sciences, Flinders University, Room S268, South Wing, Sturt Building, Bedford Park, Adelaide 5042, South Australia, Australia.'}, {'ForeName': 'Lance C', 'Initials': 'LC', 'LastName': 'Dalleck', 'Affiliation': 'Caring Futures Institute & SHAPE Research Centre, Exercise Science and Clinical Exercise Physiology, College of Nursing and Health Sciences, Flinders University, Room S268, South Wing, Sturt Building, Bedford Park, Adelaide 5042, South Australia, Australia.'}, {'ForeName': 'Caitlin E', 'Initials': 'CE', 'LastName': 'Keith', 'Affiliation': 'Caring Futures Institute & SHAPE Research Centre, Exercise Science and Clinical Exercise Physiology, College of Nursing and Health Sciences, Flinders University, Room S268, South Wing, Sturt Building, Bedford Park, Adelaide 5042, South Australia, Australia.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Fennell', 'Affiliation': 'Caring Futures Institute & SHAPE Research Centre, Exercise Science and Clinical Exercise Physiology, College of Nursing and Health Sciences, Flinders University, Room S268, South Wing, Sturt Building, Bedford Park, Adelaide 5042, South Australia, Australia.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Lee', 'Affiliation': 'Caring Futures Institute & SHAPE Research Centre, Exercise Science and Clinical Exercise Physiology, College of Nursing and Health Sciences, Flinders University, Room S268, South Wing, Sturt Building, Bedford Park, Adelaide 5042, South Australia, Australia.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Drummond', 'Affiliation': 'Caring Futures Institute & SHAPE Research Centre, Exercise Science and Clinical Exercise Physiology, College of Nursing and Health Sciences, Flinders University, Room S268, South Wing, Sturt Building, Bedford Park, Adelaide 5042, South Australia, Australia.'}, {'ForeName': 'Shelley E', 'Initials': 'SE', 'LastName': 'Keating', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Fassett', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Coombes', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane 4072, Queensland, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17103695']
3171,30250241,"The effect of brisk walking in the fasted versus fed state on metabolic responses, gastrointestinal function, and appetite in healthy men.","OBJECTIVE


To investigate the effect of brisk walking in the fasted versus fed state on gastric emptying rate (GER), metabolic responses and appetite hormone responses.
SUBJECTS/METHODS


Twelve healthy men completed two 45 min treadmill walks, fasted (FASTED) and followed consumption of a standardised breakfast (FED). GER of a standardised lunch was subsequently measured for 2 h using the  13 C-breath test method. Blood samples were collected at baseline, post-breakfast period, pre-exercise, immediately post exercise, pre-lunch then every 30 min following lunch for 2 h. Circulating concentrations of acylated ghrelin (GHR), glucagon-like peptide-1 (GLP-1), peptide tyrosine tyrosine (PYY), pancreatic polypeptide (PP), glucose, insulin, triglycerides, non-esterified fatty acids (NEFA) and cholesterol were measured. Subjective feelings of appetite were assessed at 15 min intervals throughout. Substrate utilisation was measured every 30 min, and continuously throughout exercise by indirect calorimetry.
RESULTS


No differences were observed for GER T ½  (FASTED 89 ± 22 vs. FED 89 ± 24 min, P = 0.868) nor T lag  (FASTED 55 ± 15 vs. FED 54 ± 14 min, P = 0.704). NEFA concentrations were higher in FASTED at pre-exercise, post exercise and 30 min post exercise (pre-lunch) (all P < 0.05) but no differences were observed for glucose, cholesterol or triglycerides. Carbohydrate oxidation was greater at all time-points during FED exercise (all P < 0.05). Minimal changes in appetite were observed post lunch ingestion with no differences in PYY or GHR observed between trials. GLP-1 concentrations were greater in FED post-breakfast and pre-exercise (P < 0.05), though no differences were observed after lunch. A greater concentration of PP was observed in FED from pre-exercise to 30 min post lunch consumption (all P < 0.05). Insulin concentrations were higher in FED pre-exercise but higher in FASTED 1.5 h post lunch (P < 0.05).
CONCLUSION


These findings suggest that gastrointestinal function, hunger and appetite regulatory hormones are not sensitive to low-intensity bouts of physical activity and holds positive implications for weight management practices.",2019,"GLP-1 concentrations were greater in FED post-breakfast and pre-exercise (P < 0.05), though no differences were observed after lunch.","['Twelve healthy men completed two', 'healthy men']","['brisk walking', '45\u2009min treadmill walks, fasted (FASTED) and followed consumption of a standardised breakfast (FED', 'glucagon-like peptide-1 ']","['GLP-1), peptide tyrosine tyrosine (PYY), pancreatic polypeptide (PP), glucose, insulin, triglycerides, non-esterified fatty acids (NEFA) and cholesterol', 'glucose, cholesterol or triglycerides', 'Carbohydrate oxidation', 'concentration of PP', 'Substrate utilisation', 'Insulin concentrations', 'Subjective feelings of appetite', 'metabolic responses, gastrointestinal function, and appetite', 'appetite', 'gastric emptying rate (GER), metabolic responses and appetite hormone responses', 'GLP-1 concentrations', 'NEFA concentrations']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0443162', 'cui_str': 'Brisk'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}]","[{'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0077599', 'cui_str': 'tyrosyltyrosine'}, {'cui': 'C0030298', 'cui_str': 'Pancreatic peptide'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0369212', 'cui_str': 'Esterified fatty acid'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}]",12.0,0.0837764,"GLP-1 concentrations were greater in FED post-breakfast and pre-exercise (P < 0.05), though no differences were observed after lunch.","[{'ForeName': 'Victoria J', 'Initials': 'VJ', 'LastName': 'McIver', 'Affiliation': 'School of Healthcare Science, Manchester Metropolitan University, Manchester, M1 5GD, UK.'}, {'ForeName': 'Lewis', 'Initials': 'L', 'LastName': 'Mattin', 'Affiliation': 'School of Healthcare Science, Manchester Metropolitan University, Manchester, M1 5GD, UK.'}, {'ForeName': 'Gethin H', 'Initials': 'GH', 'LastName': 'Evans', 'Affiliation': 'School of Healthcare Science, Manchester Metropolitan University, Manchester, M1 5GD, UK.'}, {'ForeName': 'Adora M W', 'Initials': 'AMW', 'LastName': 'Yau', 'Affiliation': 'School of Healthcare Science, Manchester Metropolitan University, Manchester, M1 5GD, UK. a.yau@mmu.ac.uk.'}]",International journal of obesity (2005),['10.1038/s41366-018-0215-x']
3172,30538278,"Associations between reliable changes in depression and changes in BMI, total body fatness and visceral adiposity during a 12-month weight loss trial.","We investigated associations between changes in depression and body composition over a 12-month weight loss trial. Of the 298 adults (BMI > 27 m/kg 2 ), 219 with complete depression and body composition data were included. A 10-item Center for Epidemiologic Studies Depression Scale measured depression; dual-energy X-ray absorptiometry measured body composition. Multinomial logistic regression predicted reliable changes in depression by BMI, body fat (BF) and visceral adiposity (VAT). Multiplicative interaction terms tested modification by sex and ethnicity. Participants with increases in body composition were less likely to experience improvements in depression (BMI: RRR = 0.79 (0.68-0.91), p < 0.01; BF: RRR = 0.97 (0.94 - 0.99), p = 0.01; VAT: RRR = 0.99 (0.98-1.00), p = 0.02), but not worsening of depression (BMI: RRR = 1.29 (0.96-1.73), p = 0.10; BF: RRR = 1.04 (0.99-1.09), p = 0.15; VAT: RRR = 1.01 (1.00-1.03), p = 0.18). Sex and ethnicity interaction terms were not significant. However, the relationship was only significant among females, among non-Latinos for BMI and BF, and among Latinos for VAT. Our study supports the association between depression and obesity and highlights the need for longitudinal studies investigating VAT and depression in diverse ethnic groups.",2019,"Participants with increases in body composition were less likely to experience improvements in depression (BMI: RRR = 0.79 (0.68-0.91), p < 0.01; BF: RRR = 0.97 (0.94 - 0.99), p = 0.01; VAT: RRR = 0.99 (0.98-1.00), p = 0.02), but not worsening of depression (BMI: RRR = 1.29 (0.96-1.73), p = 0.10; BF: RRR = 1.04 (0.99-1.09), p = 0.15; VAT: RRR = 1.01 (1.00-1.03), p = 0.18).","['298 adults (BMI\u2009>\u200927\u2009m/kg 2 ), 219 with complete depression and body composition data were included']",[],"['depression and changes in BMI, total body fatness and visceral adiposity', 'body composition', 'depression by BMI, body fat (BF) and visceral adiposity (VAT']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}]",298.0,0.0200185,"Participants with increases in body composition were less likely to experience improvements in depression (BMI: RRR = 0.79 (0.68-0.91), p < 0.01; BF: RRR = 0.97 (0.94 - 0.99), p = 0.01; VAT: RRR = 0.99 (0.98-1.00), p = 0.02), but not worsening of depression (BMI: RRR = 1.29 (0.96-1.73), p = 0.10; BF: RRR = 1.04 (0.99-1.09), p = 0.15; VAT: RRR = 1.01 (1.00-1.03), p = 0.18).","[{'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Cameron', 'Affiliation': 'University of California San Diego School of Medicine, 9500 Gilman Drive, La Jolla, CA, 92093, USA. ncameron1002@gmail.com.'}, {'ForeName': 'Job G', 'Initials': 'JG', 'LastName': 'Godino', 'Affiliation': 'Center for Wireless and Population Health Systems, 9500 Gilman Drive, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Tricia', 'Initials': 'T', 'LastName': 'Skipper', 'Affiliation': 'Department of Family Medicine and Public Health UC San Diego, 9500 Gilman Drive, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Dillon', 'Affiliation': 'Center for Wireless and Population Health Systems, 9500 Gilman Drive, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Waalen', 'Affiliation': 'Department of Family Medicine and Public Health UC San Diego, 9500 Gilman Drive, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Hill', 'Affiliation': 'Center for Wireless and Population Health Systems, 9500 Gilman Drive, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Patrick', 'Affiliation': 'Department of Family Medicine and Public Health UC San Diego, 9500 Gilman Drive, La Jolla, CA, 92093, USA.'}]",International journal of obesity (2005),['10.1038/s41366-018-0272-1']
3173,32460414,The effects of home noninvasive ventilation on the quality of life and physiological parameters of patients with chronic respiratory failure.,"INTRODUCTION


Home noninvasive mechanical ventilation (HNIV) in patients with chronic hypercapnic respiratory failure (CHRF) may improve the health-related quality of life (HRQoL) and reduce hospitalizations.
OBJECTIVE


To determine the effects of HNIV on HRQoL, sleep quality and hospitalization rates in restrictive thoracic diseases (RTD) and chronic obstructive pulmonary disease (COPD) patients with CHRF.
METHODS


In this prospective, single center study patients divided into two groups; the COPD and the RTD groups. HRQoL assessed by The Medical Outcome Study 36-Item Short-form Health Survey (SF-36) and Severe Respiratory Insufficiency (SRI); the sleep quality was assessed by Epworth and Pittsburgh Sleep Quality Index questionnaires. The patients were reevaluated first month, third months, sixth months and 1 year following HNIV establishment, during which time, hospitalization rates were recorded.
RESULTS


Ninety (COPD n = 50, RTD n = 40) out of 102 eligible patients completed the study. Significant improvements in blood gases and HRQoL were observed in the first month of HNIV establishment and remained stable. Mean ± SD SRI summary scale improved significantly from 30 ± 12 baseline to 65 ± 16 at 1 year in COPD group (P < 0.001) and from 39 ± 13 to 63 ± 18 in RTD group (P < 0.001). HNIV reduced hospitalization rates from a mean of 1.9 ± 1.1 to 0.5 ± 0.9 in COPD group (P < 0.001) and a mean of 1.9 ± 1 to 0.5 ± 0.7 in RTD group (P < 0.001).
CONCLUSION


HNIV improves HRQoL, sleep quality and gas exchange and reduces hospitalizations in patients with CHRF regardless of etiology.",2020,Mean±SD SRI summary scale improved significantly from 30±12 baseline to 65±16 at one year in COPD group (p<0.001) and from 39±13 to 63±18 in RTD group (p<0.001).,"['patients with CHRF regardless of etiology', 'COPD n=50, RTD n=40) out of 102 eligible patients completed the study', 'restrictive thoracic diseases (RTD) and COPD patients with CHRF', 'patients with chronic hypercapnic respiratory failure (CHRF', 'Ninety', 'Patients with Chronic Respiratory Failure']","['Home Noninvasive Ventilation', 'Home noninvasive mechanical ventilation (HNIV', 'HNIV']","['blood gases and HRQL', 'Epworth and Pitsburg Sleep Quality Index (PSQI) questionnaires', 'Quality Of Life and Physiological Parameters', 'Mean±SD SRI summary scale', 'hospitalization rates', 'HRQL assessed by The Medical Outcome Study 36-Item Short-form Health Survey (SF-36) and Severe Respiratory Insufficiency (SRI); the sleep quality', 'HRQoL, sleep quality and gas exchange and reduces hospitalizations', 'HRQL, sleep quality and hospitalization rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960052', 'cui_str': 'Chronic hypercapnic respiratory failure'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0039978', 'cui_str': 'Disorder of thorax'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0264492', 'cui_str': 'Chronic respiratory failure'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C1868982', 'cui_str': 'Noninvasive mechanical ventilation'}]","[{'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0034088', 'cui_str': 'Pulmonic valve regurgitation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",102.0,0.0463646,Mean±SD SRI summary scale improved significantly from 30±12 baseline to 65±16 at one year in COPD group (p<0.001) and from 39±13 to 63±18 in RTD group (p<0.001).,"[{'ForeName': 'Aycan', 'Initials': 'A', 'LastName': 'Yüksel', 'Affiliation': 'Faculty of Medicine, Department of Chest Diseases, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Çiftçi', 'Affiliation': 'Faculty of Medicine, Department of Chest Diseases, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Aydın', 'Initials': 'A', 'LastName': 'Çiledağ', 'Affiliation': 'Faculty of Medicine, Department of Chest Diseases, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Akın', 'Initials': 'A', 'LastName': 'Kaya', 'Affiliation': 'Faculty of Medicine, Department of Chest Diseases, Ankara University, Ankara, Turkey.'}]",The clinical respiratory journal,['10.1111/crj.13221']
3174,32468989,An extended stroke rehabilitation service for people who have had a stroke: the EXTRAS RCT.,"BACKGROUND


There is limited evidence about the effectiveness of rehabilitation in meeting the longer-term needs of stroke patients and their carers.
OBJECTIVE


To determine the clinical effectiveness and cost-effectiveness of an extended stroke rehabilitation service (EXTRAS).
DESIGN


A pragmatic, observer-blind, parallel-group, multicentre randomised controlled trial with embedded health economic and process evaluations. Participants were randomised (1 : 1) to receive EXTRAS or usual care.
SETTING


Nineteen NHS study centres.
PARTICIPANTS


Patients with a new stroke who received early supported discharge and their informal carers.
INTERVENTIONS


Five EXTRAS reviews provided by an early supported discharge team member between 1 and 18 months post early supported discharge, usually over the telephone. Reviewers assessed rehabilitation needs, with goal-setting and action-planning. Control treatment was usual care post early supported discharge.
MAIN OUTCOME MEASURES


The primary outcome was performance in extended activities of daily living (Nottingham Extended Activities of Daily Living Scale) at 24 months post randomisation. Secondary outcomes at 12 and 24 months included patient mood (Hospital Anxiety and Depression Scale), health status (Oxford Handicap Scale), experience of services and adverse events. For carers, secondary outcomes included carers' strain (Caregiver Strain Index) and experience of services. Cost-effectiveness was estimated using resource utilisation costs (adaptation of the Client Service Receipt Inventory) and quality-adjusted life-years.
RESULTS


A total of 573 patients (EXTRAS,  n  = 285; usual care,  n  = 288) with 194 carers (EXTRAS,  n  = 103; usual care,  n  = 91) were randomised. Mean 24-month Nottingham Extended Activities of Daily Living Scale scores were 40.0 (standard deviation 18.1) for EXTRAS ( n  = 219) and 37.2 (standard deviation 18.5) for usual care ( n  = 231), giving an adjusted mean difference of 1.8 (95% confidence interval -0.7 to 4.2). The mean intervention group Hospital Anxiety and Depression Scale scores were not significantly different at 12 and 24 months. The intervention did not improve patient health status or carer strain. EXTRAS patients and carers reported greater satisfaction with some aspects of care. The mean cost of resource utilisation was lower in the intervention group: -£311 (95% confidence interval -£3292 to £2787), with a 68% chance of EXTRAS being cost-saving. EXTRAS was associated with 0.07 (95% confidence interval 0.01 to 0.12) additional quality-adjusted life-years. At current conventional thresholds of willingness to pay for a quality-adjusted life-year, there is a 90% chance that EXTRAS is cost-effective.
CONCLUSIONS


EXTRAS did not improve stroke survivors' performance in extended activities of daily living but did improve their overall satisfaction with services. Given the impact on costs and quality-adjusted life-years, there is a high chance that EXTRAS could be considered cost-effective.
FUTURE WORK


Further research is required to identify whether or not community-based interventions can improve performance of extended activities of daily living, and to understand the improvements in health-related quality of life and costs seen by provision of intermittent longer-term specialist review.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN45203373.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 24, No. 24. See the NIHR Journals Library website for further project information.",2020,"CONCLUSIONS


EXTRAS did not improve stroke survivors' performance in extended activities of daily living but did improve their overall satisfaction with services.","['573 patients (EXTRAS,  n \u2009=\u2009285; usual care,  n \u2009=\u2009288) with 194 carers (EXTRAS,  n \u2009=\u2009103; usual care,  n \u2009=\u200991', 'Patients with a new stroke who received early supported discharge and their informal carers', 'Nineteen NHS study centres', 'people who have had a stroke']","['EXTRAS', 'extended stroke rehabilitation service (EXTRAS', 'EXTRAS or usual care']","[""stroke survivors' performance"", 'Cost-effectiveness', 'patient mood (Hospital Anxiety and Depression Scale), health status (Oxford Handicap Scale), experience of services and adverse events', 'clinical effectiveness and cost-effectiveness', 'mean cost of resource utilisation', 'performance in extended activities of daily living (Nottingham Extended Activities of Daily Living Scale', 'Nottingham Extended Activities of Daily Living Scale scores', 'patient health status or carer strain', 'mean intervention group Hospital Anxiety and Depression Scale scores', ""carers' strain (Caregiver Strain Index) and experience of services"", 'resource utilisation costs (adaptation of the Client Service Receipt Inventory) and quality-adjusted life-years']","[{'cui': 'C4708164', 'cui_str': '573'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0204097', 'cui_str': 'Stroke rehabilitation'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0204097', 'cui_str': 'Stroke rehabilitation'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",573.0,0.212998,"CONCLUSIONS


EXTRAS did not improve stroke survivors' performance in extended activities of daily living but did improve their overall satisfaction with services.","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Shaw', 'Affiliation': 'Stroke Research Group, Institute of Neuroscience, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Nawaraj', 'Initials': 'N', 'LastName': 'Bhattarai', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Cant', 'Affiliation': 'Service user, c/o Stroke Research Group, Institute of Neuroscience, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Avril', 'Initials': 'A', 'LastName': 'Drummond', 'Affiliation': ""School of Health Sciences, Medical School, Queen's Medical Centre, University of Nottingham, Nottingham, UK.""}, {'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Ford', 'Affiliation': 'Stroke Research Group, Institute of Neuroscience, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Forster', 'Affiliation': 'Academic Unit of Elderly Care and Rehabilitation, School of Medicine, Faculty of Medicine and Health, University of Leeds, Leeds, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Francis', 'Affiliation': 'Stroke Research Group, Institute of Neuroscience, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Hills', 'Affiliation': 'Stroke Research Group, Institute of Neuroscience, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Howel', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Laverty', 'Affiliation': 'Stroke Service, Wansbeck General Hospital, Northumbria Healthcare NHS Foundation Trust, Northumberland, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'McKevitt', 'Affiliation': ""School of Population Health and Environmental Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'McMeekin', 'Affiliation': 'Department of Nursing, Midwifery and Health, Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Price', 'Affiliation': 'Stroke Research Group, Institute of Neuroscience, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Stamp', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Stevens', 'Affiliation': ""School of Population Health and Environmental Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Vale', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Rodgers', 'Affiliation': 'Stroke Research Group, Institute of Neuroscience, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24240']
3175,32464351,Efficacy and safety of 5-Hydroxytryptophan on levodopa-induced motor complications in Parkinson's disease: A preliminary finding.,"BACKGROUND AND PURPOSE


Several studies have indicated that altered serotonergic neurotransmission may contribute to the motor features commonly associated with Parkinson's disease (PD) drug treatment such as levodopa-induced dyskinesias (LIDs). 5-Hydroxytryptophan (5-HTP) is the immediate precursor of serotonin. We have recently demonstrated that 5-HTP produces significant antidyskinetic effects in a rat model of PD. To date, there has been inconsistent research on the use of 5-HTP in PD. The purpose of this study was to compare the effects of 5-HTP versus placebo on levodopa-induced motor complications in PD patients.
MATERIAL AND METHODS


A single-center, randomized, double-blind placebo-controlled cross-over study was performed. A total of 12 PD patients were diagnosed with LIDs and motor fluctuactions and subsequently were randomized to intervention; 11 subjects completed the entire 16-week protocol. Patients received placebo or 50 mg of 5-HTP daily in a cross-over design over a period of 4 weeks. For the assessment of efficacy on the motor functions and motor complications, the UPDRS (parts III and IV), Unified Dyskinesia Rating Scale (UDysRS), Wearing-Off Questionnaire (WOQ-19) and the self-reported 24-h home dyskinesia diaries were obtained at baseline and weeks 4, 8, 12 and 16 (T-end).
RESULTS


Repeated measures analysis revealed a significant improvement of LIDs during the 50 mg 5-HTP treatment as assessed by the UDysRS and UPDRS-IV scores.
CONCLUSIONS


This study provides preliminary evidence of clinical benefit of 5-HTP against LIDs in PD. Larger studies with a longer treatment duration and a wider range of doses are warranted to corroborate these findings.",2020,"RESULTS


Repeated measures analysis revealed a significant improvement of LIDs during the 50 mg 5-HTP treatment as assessed by the UDysRS and UPDRS-IV scores.
","['PD patients', ""Parkinson's disease"", '12 PD patients were diagnosed with LIDs and motor fluctuactions and subsequently were randomized to intervention; 11 subjects completed the entire 16-week protocol']","['5-Hydroxytryptophan', '5-HTP versus placebo', '5-Hydroxytryptophan (5-HTP', '5-HTP', 'placebo or 50\xa0mg of 5-HTP', '5-HTP against LIDs', 'placebo']","['UDysRS and UPDRS-IV scores', 'Efficacy and safety', 'motor functions and motor complications, the UPDRS (parts III and IV), Unified Dyskinesia Rating Scale (UDysRS), Wearing-Off Questionnaire (WOQ-19) and the self-reported 24-h home dyskinesia diaries', 'LIDs']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0000578', 'cui_str': '5-Hydroxytryptophan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}]","[{'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",,0.222511,"RESULTS


Repeated measures analysis revealed a significant improvement of LIDs during the 50 mg 5-HTP treatment as assessed by the UDysRS and UPDRS-IV scores.
","[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Meloni', 'Affiliation': 'Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy. Electronic address: mario.meloni@hotmail.it.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Puligheddu', 'Affiliation': 'Sleep Disorders Center, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy; Department of Medical Sciences and Public Health, Neurology Unit, University of Cagliari and AOU Cagliari, Monserrato, Cagliari, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Sanna', 'Affiliation': 'Department of Biomedical Sciences, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Cannas', 'Affiliation': 'Department of Medical Sciences and Public Health, Neurology Unit, University of Cagliari and AOU Cagliari, Monserrato, Cagliari, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Farris', 'Affiliation': 'Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Tronci', 'Affiliation': 'Department of Biomedical Sciences, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Figorilli', 'Affiliation': 'Sleep Disorders Center, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Defazio', 'Affiliation': 'Department of Medical Sciences and Public Health, Neurology Unit, University of Cagliari and AOU Cagliari, Monserrato, Cagliari, Italy.'}, {'ForeName': 'Manolo', 'Initials': 'M', 'LastName': 'Carta', 'Affiliation': 'Department of Biomedical Sciences, University of Cagliari, Cagliari, Italy.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116869']
3176,32472801,Prophylactic Intrathecal Morphine and Prevention of Post-Dural Puncture Headache: A Randomized Double-blind Trial: Erratum.,,2020,,['Post-Dural Puncture Headache'],['Prophylactic Intrathecal Morphine'],[],"[{'cui': 'C0270697', 'cui_str': 'Headache following lumbar puncture'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]",[],,0.674421,,[],Anesthesiology,['10.1097/ALN.0000000000003411']
3177,32470710,Adjuvant therapy with pegylated interferon-alfa2b vs observation in stage II B/C patients with ulcerated primary: Results of the European Organisation for Research and Treatment of Cancer 18081 randomised trial.,"BACKGROUND


Subgroup analyses of two large EORTC adjuvant interferon-alpha2b (IFNα-2b) vs observation randomised trials demonstrated that a treatment benefit was observed only in patients with an ulcerated melanoma without palpable nodes (hazard ratio [HR] for recurrence-free survival [RFS] was 0.69). This was confirmed by a meta-analysis of 15 adjuvant IFN trials (HR: 0.79).
PATIENTS AND METHODS


In the EORTC 18081 trial, sentinel node-negative stage II patients with an ulcerated primary melanoma were 1:1 randomised between pegylated (PEG)-IFNα-2b at 3 μg/kg/week subcutaneously and observation, for 2 years, or until disease recurrence or unacceptable toxicity in spite of dose adjustments to maintain an Eastern Cooperative Oncology Group performance status of 0 or 1. Main end-point was RFS. Secondary end-points included distant metastasis-free survival (DMFS), overall survival, and safety (EudraCT Number: 2009-010273-20).
RESULTS


Between February 2013 and January 2017, only 112 patients were randomised, 56 in each arm. The trial was stopped early for lack of recruitment. At a 3.4-year median follow-up, the estimated HR for the PEG-IFNα-2b group compared with the observation group regarding RFS was 0.66 (95% confidence interval [CI]: 0.32-1.37), and the 3-year RFS rate was 80.0% (95% CI: 65.7-88.8%) and 72.9% (95% CI: 58.3-83.0%), respectively. DMFS was prolonged: HR: 0.39 (95% CI: 0.15-0.97), and the 3-year DMFS rate was 90.6% (95% CI: 78.9-96.0%) vs 76.4% (95% CI: 62.1-85.9%). One patient in the PEG-IFNα-2b group died compared with 4 in the observation group. Fifty-four patients started PEG-IFNα-2b treatment, 16 (29%) completed 2 years of treatment, 2 (4%) stopped due to recurrence, 23 (43%) due to toxicity and 14 (25%) due to other reasons.
CONCLUSIONS


The EORTC 18081 PEG-IFNα-2b randomised trial, observed a similar HR (0.69) for RFS as the previous EORTC trials (0.69). In countries without access to new drugs, adjuvant (PEG)-IFNα-2b treatment is an option for patients with ulcerated melanomas without palpable nodes.",2020,"At a 3.4-year median follow-up, the estimated HR for the PEG-IFNα-2b group compared with the observation group regarding RFS was 0.66 (95% confidence interval [CI]: 0.32-1.37), and the 3-year RFS rate was 80.0% (95% CI: 65.7-88.8%) and 72.9% (95% CI: 58.3-83.0%), respectively.","['only 112 patients were randomised, 56 in each arm', 'stage II B/C patients with ulcerated primary', 'sentinel node-negative stage II patients with an ulcerated primary melanoma', 'patients with ulcerated melanomas without palpable nodes', 'Between February 2013 and January 2017']","['adjuvant (PEG)-IFNα-2b treatment', 'pegylated interferon-alfa2b vs observation', 'pegylated (PEG)-IFNα-2b']","['distant metastasis-free survival (DMFS), overall survival, and safety (EudraCT Number: 2009-010273-20', '3-year RFS rate', 'DMFS', 'toxicity', '3-year DMFS rate']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0677944', 'cui_str': 'Sentinel node'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0522499', 'cui_str': 'Palpable'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0341703', 'cui_str': 'Adult Fanconi syndrome'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.689158,"At a 3.4-year median follow-up, the estimated HR for the PEG-IFNα-2b group compared with the observation group regarding RFS was 0.66 (95% confidence interval [CI]: 0.32-1.37), and the 3-year RFS rate was 80.0% (95% CI: 65.7-88.8%) and 72.9% (95% CI: 58.3-83.0%), respectively.","[{'ForeName': 'Alexander M M', 'Initials': 'AMM', 'LastName': 'Eggermont', 'Affiliation': 'Prinses Maxima Centrum, Utrecht, the Netherlands. Electronic address: alexander.eggermont@prinsesmaximacentrum.nl.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland. Electronic address: piotr.rutkowski@pib-nio.pl.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dutriaux', 'Affiliation': 'CHU de Bordeaux, Groupe Hospitalier Saint-André, Hopital Saint-André, Bordeaux, France. Electronic address: caroline.dutriaux@chu-bordeaux.fr.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Hofman-Wellenhof', 'Affiliation': 'Medical University of Graz, Graz, Austria. Electronic address: rainer.hofmann@medunigraz.at.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dziewulski', 'Affiliation': 'Mid Essex Hospitals, Broomfield Hospital, Broomfield, United Kingdom. Electronic address: peter.dziewulski@meht.nhs.uk.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Marples', 'Affiliation': ""Leeds Teaching Hospitals NHS Trust, St. James's University Hospital, Leeds, United Kingdom. Electronic address: maria.marples@nhs.net.""}, {'ForeName': 'Floren', 'Initials': 'F', 'LastName': 'Grange', 'Affiliation': 'CHU de Reims, Hôpital Robert Debré, Reims, France. Electronic address: fgrange@chu-reims.fr.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Lok', 'Affiliation': 'CHU Amiens, Hopital Sud, Amiens, France. Electronic address: lok.catherine@chu-amiens.fr.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Pennachioli', 'Affiliation': 'Istituto Europeo di Oncologia, Milan, Italy. Electronic address: elisabetta.pennacchioli@ieo.it.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Gustave Roussy, Villejuif & Paris-Saclay University, Saint-Aubin, France. Electronic address: caroline.robert@gustaveroussy.fr.'}, {'ForeName': 'Alexander C J', 'Initials': 'ACJ', 'LastName': 'van Akkooi', 'Affiliation': 'Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, the Netherlands. Electronic address: a.v.akkooi@nki.nl.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bastholt', 'Affiliation': 'Odense University Hospital, Odense, Denmark. Electronic address: lars.bastholt@rsyd.dk.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Minisini', 'Affiliation': 'Azienda Sanitaria Universitaria Del Friuli Centrale, Udine, Italy. Electronic address: alessandro.minisini@asufc.sanita.fvg.it.'}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Marshall', 'Affiliation': 'St Helens & Knowsley NHS Trust, Whiston Hospital, Prescot, United Kingdom. Electronic address: emarshall@nhs.net.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Salès', 'Affiliation': 'Institut Jules Bordet-Hopital Universitaire ULB, Brussels, Belgium. Electronic address: fsales@bordet.be.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Assistance Publique, Hopitaux de Marseille, Hôpital de La Timone (APHM), Marseille, France. Electronic address: jean-jacques.grob@ap-hm.fr.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Bechter', 'Affiliation': 'Department of General Medical Oncology, University Hospitals Leuven, Campus Gasthuisberg, Leuven, Belgium. Electronic address: oliver.bechter@uzleuven.be.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'University Hospital Essen, Essen & German Cancer Consortium, Heidelberg, Germany. Electronic address: dirk.schadendorf@uk-essen.de.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Marreaud', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium. Electronic address: sandrine.marreaud@eortc.org.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kicinski', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium. Electronic address: michal.kicinski@eortc.org.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Suciu', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium. Electronic address: stefan.suciu@eortc.org.'}, {'ForeName': 'Alessandro A E', 'Initials': 'AAE', 'LastName': 'Testori', 'Affiliation': 'Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. Electronic address: A.Testori@smatteo.pv.it.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.04.015']
3178,32470863,The effect of Korean Red Ginseng on sarcopenia biomarkers in type 2 diabetes patients.,"BACKGROUND


The elderly population is growing rapidly worldwide and sarcopenia, which is considered as a new geriatric syndrome has become an important issue. In particular, diabetes is known to be an important risk factor for sarcopenia. In this study, we investigated the effects of Korean Red Ginseng (KRG) on biomarkers of sarcopenia in middle and old age diabetes patients.
PATIENTS AND METHODS


This study was a randomized, double-blind, placebo-controlled trial. Participants were randomly allocated to either the placebo or KRG group and took corresponding tablets for 24 weeks. The primary outcomes were changes in sarcopenia biomarkers at week 24. Secondary outcomes were changes in inflammatory and antioxidant markers and lean body mass at week 24.
RESULTS


Fifty-nine patients completed the study. Follistatin and sex hormone binding globulin (SHBG) were significantly improved in KRG group. In the subgroup analysis, female postmenopausal patients over the age of 55 showed a significant improvement in serum SHBG, follistatin, and growth differentiation factor 15 (GDF-15) and an attenuated reduction in Troponin T (TNT) after the administration of KRG.
CONCLUSION


Twenty-four week administration of KRG in diabetes patients resulted in a significant improvement in follistatin and SHBG levels, especially in old postmenopausal women. A further, larger population study with a longer follow-up period is warranted to verify and understand the effects of KRG on sarcopenia.",2020,"Twenty-four week administration of KRG in diabetes patients resulted in a significant improvement in follistatin and SHBG levels, especially in old postmenopausal women.","['type 2 diabetes patients', 'Fifty-nine patients completed the study', 'middle and old age diabetes patients', 'old postmenopausal women']","['placebo or KRG', 'Korean Red Ginseng (KRG', 'KRG', 'Korean Red Ginseng', 'placebo']","['serum SHBG, follistatin, and growth differentiation factor 15 (GDF-15) and an attenuated reduction in Troponin T (TNT', 'sarcopenia biomarkers', 'changes in inflammatory and antioxidant markers and lean body mass', 'changes in sarcopenia biomarkers', 'follistatin and SHBG levels', 'Follistatin and sex hormone binding globulin (SHBG']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0873137', 'cui_str': 'Korean ginseng preparation'}]","[{'cui': 'C0455307', 'cui_str': 'Serum sex hormone binding globulin measurement'}, {'cui': 'C0060623', 'cui_str': 'Activin-Binding Protein'}, {'cui': 'C0668195', 'cui_str': 'Macrophage Inhibitory Cytokine 1'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0202218', 'cui_str': 'Sex hormone binding globulin measurement'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}]",59.0,0.135337,"Twenty-four week administration of KRG in diabetes patients resulted in a significant improvement in follistatin and SHBG levels, especially in old postmenopausal women.","[{'ForeName': 'Kahui', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, 63 gil 20, Eonguro, Gangnam-gu, Seoul, 06229, Republic of Korea.'}, {'ForeName': 'Chul Woo', 'Initials': 'CW', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, 63 gil 20, Eonguro, Gangnam-gu, Seoul, 06229, Republic of Korea; Severance Institute for Vascular and Metabolic Research, College of Medicine, Yonsei University, 211 Eonguro, Gangnam-gu, Seoul, 06288, Republic of Korea.'}, {'ForeName': 'YuSik', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Severance Institute for Vascular and Metabolic Research, College of Medicine, Yonsei University, 211 Eonguro, Gangnam-gu, Seoul, 06288, Republic of Korea. Electronic address: cromoton@yuhs.ac.'}, {'ForeName': 'Ji Sun', 'Initials': 'JS', 'LastName': 'Nam', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, 63 gil 20, Eonguro, Gangnam-gu, Seoul, 06229, Republic of Korea; Severance Institute for Vascular and Metabolic Research, College of Medicine, Yonsei University, 211 Eonguro, Gangnam-gu, Seoul, 06288, Republic of Korea. Electronic address: jisunn@yuhs.ac.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104108']
3179,32474204,Effect on thromboprophylaxis among hospitalized patients using a system-wide multifaceted quality improvement intervention: Rationale and design for a multicenter cluster randomized clinical trial in China.,"BACKGROUND


Venous thromboembolism (VTE) is a life-threatening disease that can affect each hospitalized patient. But the current in-hospital thromboprophylaxis remains suboptimal and there exists a large gap between clinical practice and guideline-recommended care in China.
METHODS


To facilitate implementation of guideline recommendations, we conduct a multicenter, adjudicator-blinded, cluster-randomized clinical trial, aiming to assess the effectiveness of a system-wide multifaceted quality improvement (QI) strategy on VTE prophylaxis improvement and thromboembolism reduction in clinical setting. Hospitals are randomized into intervention or control group. In intervention group, hospitals receive the concept of appropriate in-hospital thromboprophylaxis plus a multifaceted QI which encompasses four components: (1) an electronic alert combining computer-based clinical decision support system and electronic reminders, (2) appropriate prophylaxis based on dynamic VTE and bleeding risk assessments, (3) periodical audit and interactive feedback on performance, (4) strengthened training and patient education. In control, hospitals receive the concept of recommended prophylaxis alone without QI. Thromboprophylaxis will be at the discretion of hospitals and conducted as usual. With a final sample size of 5760 hospitalized patients in 32 hospitals on mainland China, this trial will examine the effect of QI on improvement in thromboprophylaxis and patient-centered outcomes. This is an open-label trial that patients and healthcare professionals will know group allocation after enrollment, but endpoint adjudicators and statisticians will be blinded. RCT# NCT04211181 CONCLUSIONS: The system-wide multifaceted QI intervention is expected to facilitate implementation of recommended VTE prophylaxis in hospital, thereafter reducing VTE incidence and relevant adverse events among hospitalized patients in China.",2020,"The system-wide multifaceted QI intervention is expected to facilitate implementation of recommended VTE prophylaxis in hospital, thereafter reducing VTE incidence and relevant adverse events among hospitalized patients in China.","['hospitalized patients using a', '5760 hospitalized patients in 32 hospitals on mainland China', 'hospitalized patients in China']","['system-wide multifaceted quality improvement intervention', 'hospitals receive the concept of appropriate in-hospital thromboprophylaxis plus a multifaceted QI which encompasses four components: (1) an electronic alert combining computer-based clinical decision support system and electronic reminders, (2) appropriate prophylaxis based on dynamic VTE and bleeding risk assessments, (3) periodical audit and interactive feedback on performance, (4) strengthened training and patient education', 'system-wide multifaceted quality improvement (QI) strategy', 'RCT']",[],"[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0525070', 'cui_str': 'Clinical Decision Support Systems'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}]",[],5760.0,0.127351,"The system-wide multifaceted QI intervention is expected to facilitate implementation of recommended VTE prophylaxis in hospital, thereafter reducing VTE incidence and relevant adverse events among hospitalized patients in China.","[{'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Dong', 'Affiliation': 'Institute of Clinical Medical Sciences, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Kaiyuan', 'Initials': 'K', 'LastName': 'Zhen', 'Affiliation': 'Institute of Clinical Medical Sciences, China-Japan Friendship Hospital, Beijing, China; Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China; Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Beijing, China; National Clinical Research Center for Respiratory Diseases, Beijing, China.'}, {'ForeName': 'Zhu', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China; Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Beijing, China; National Clinical Research Center for Respiratory Diseases, Beijing, China; Graduate School of Peking Union Medical College, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Chaozeng', 'Initials': 'C', 'LastName': 'Si', 'Affiliation': 'Department of information management, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Jiefeng', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': 'Department of information management, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Tieshan', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of information management, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xia', 'Affiliation': 'Medical Affairs Department of China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Nursing, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Cunbo', 'Initials': 'C', 'LastName': 'Jia', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Guangliang', 'Initials': 'G', 'LastName': 'Shan', 'Affiliation': 'Department of Epidemiology and Biostatistics, Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences, School of Basic Medicine, Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Zhenguo', 'Initials': 'Z', 'LastName': 'Zhai', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China; Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Beijing, China; National Clinical Research Center for Respiratory Diseases, Beijing, China. Electronic address: zhaizhenguo2011@126.com.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China; Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Beijing, China; National Clinical Research Center for Respiratory Diseases, Beijing, China; Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.04.020']
3180,32474206,"The INVICTUS rheumatic heart disease research program: Rationale, design and baseline characteristics of a randomized trial of rivaroxaban compared to vitamin K antagonists in rheumatic valvular disease and atrial fibrillation.","BACKGROUND


Rheumatic heart disease (RHD) is a neglected disease affecting 33 million people, mainly in low and middle income countries. Yet very few large trials or registries have been conducted in this population. The INVICTUS program of research in RHD consists of a randomized-controlled trial (RCT) of 4500 patients comparing rivaroxaban with vitamin K antagonists (VKA) in patients with RHD and atrial fibrillation (AF), a registry of 17,000 patients to document the contemporary clinical course of patients with RHD, including a focused sub-study on pregnant women with RHD within the registry. This paper describes the rationale, design, organization and baseline characteristics of the RCT and a summary of the design of the registry and its sub-study. Patients with RHD and AF are considered to be at high risk of embolic strokes, and oral anticoagulation with VKAs is recommended for stroke prevention. But the quality of anticoagulation with VKA is poor in developing countries. A drug which does not require monitoring, and which is safe and effective for preventing stroke in patients with valvular AF, would fulfill a major unmet need.
METHODS


The INVestIgation of rheumatiC AF Treatment Using VKAs, rivaroxaban or aspirin Studies (INVICTUS-VKA) trial is an international, multicentre, randomized, open-label, parallel group trial, testing whether rivaroxaban 20 mg given once daily is non-inferior (or superior) to VKA in patients with RHD, AF, and an elevated risk of stroke (mitral stenosis with valve area ≤2 cm 2 , left atrial spontaneous echo-contrast or thrombus, or a CHA 2 DS 2 VASc score ≥2). The primary efficacy outcome is a composite of stroke or systemic embolism and the primary safety outcome is the occurrence of major bleeding. The trial has enrolled 4565 patients from 138 sites in 23 countries from Africa, Asia and South America. The Registry plans to enroll an additional 17,000 patients with RHD and document their treatments, and their clinical course for at least 2 years. The pregnancy sub-study will document the clinical course of pregnant women with RHD.
CONCLUSION


INVICTUS is the largest program of clinical research focused on a neglected cardiovascular disease and will provide new information on the clinical course of patients with RHD, and approaches to anticoagulation in those with concomitant AF.",2020,The primary efficacy outcome is a composite of stroke or systemic embolism and the primary safety outcome is the occurrence of major bleeding.,"['pregnant women with RHD', 'patients with RHD, AF, and an elevated risk of stroke (mitral stenosis with valve area ≤2 cm 2 , left atrial spontaneous echo-contrast or thrombus, or a CHA 2 DS 2 VASc score ≥2', 'rheumatic valvular disease and atrial fibrillation', '17,000 patients with RHD and document their treatments, and their clinical course for at least 2 years', 'patients with valvular AF', 'enrolled 4565 patients from 138 sites in 23 countries from Africa, Asia and South America', 'Patients with RHD and AF', 'patients with RHD and atrial fibrillation (AF), a registry of 17,000 patients to document the contemporary clinical course of patients with RHD, including a focused sub-study on pregnant women with RHD within the registry', '4500 patients comparing']","['rivaroxaban with vitamin K antagonists (VKA', 'vitamin K antagonists', 'VKAs, rivaroxaban or aspirin', 'rivaroxaban', 'VKA']",['composite of stroke or systemic embolism and the primary safety outcome is the occurrence of major bleeding'],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0035439', 'cui_str': 'Rheumatic heart disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0026269', 'cui_str': 'Mitral valve stenosis'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}, {'cui': 'C0574369', 'cui_str': 'Chamorro language'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0264757', 'cui_str': 'Rheumatic disease of heart valve'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0449259', 'cui_str': 'Clinical course'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0037713', 'cui_str': 'South America'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517780', 'cui_str': '4500'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",4565.0,0.080112,The primary efficacy outcome is a composite of stroke or systemic embolism and the primary safety outcome is the occurrence of major bleeding.,"[{'ForeName': 'Ganesan', 'Initials': 'G', 'LastName': 'Karthikeyan', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi, India. Electronic address: karthik2010@gmail.com.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Mpiko', 'Initials': 'M', 'LastName': 'Ntsekhe', 'Affiliation': 'University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Benz', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Sumathy', 'Initials': 'S', 'LastName': 'Rangarajan', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Gayle', 'Initials': 'G', 'LastName': 'Lewis', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yun', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Sanjib Kumar', 'Initials': 'SK', 'LastName': 'Sharma', 'Affiliation': 'BP Koirala Institute of Health Sciences, Dharan, Nepal.'}, {'ForeName': 'Fathi', 'Initials': 'F', 'LastName': 'Maklady', 'Affiliation': 'Suez Canal University Hospital, Egypt.'}, {'ForeName': 'Alaa Eldin', 'Initials': 'AE', 'LastName': 'Elghamrawy', 'Affiliation': 'Suez Canal University Hospital, Egypt.'}, {'ForeName': 'Khawar', 'Initials': 'K', 'LastName': 'Kazmi', 'Affiliation': 'Aga Khan University Hospital, Karachi, Pakistan.'}, {'ForeName': 'Tantchou T J', 'Initials': 'TTJ', 'LastName': 'Cabral', 'Affiliation': 'St. Elizabeth Catholic General Hospital, Cameroon.'}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Dayi', 'Affiliation': 'People Hospital of Peking University, Beijing, China.'}, {'ForeName': 'Ma', 'Initials': 'M', 'LastName': 'Changsheng', 'Affiliation': 'People Hospital of Peking University, Beijing, China.'}, {'ForeName': 'Bernard M', 'Initials': 'BM', 'LastName': 'Gitura', 'Affiliation': 'Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Avezum', 'Affiliation': 'Hospital Alemão Oswaldo Cruz, Sao Paolo, Brazil.'}, {'ForeName': 'Liesl', 'Initials': 'L', 'LastName': 'Zuhlke', 'Affiliation': 'Red Cross War Memorial Childrens Hospital, Cape Town, South Africa.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lwabi', 'Affiliation': 'Uganda Heart Institute, Kampala, Uganda.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Haileamlak', 'Affiliation': 'Jimma University Hospital, Ethiopia.'}, {'ForeName': 'Okechukwu', 'Initials': 'O', 'LastName': 'Ogah', 'Affiliation': 'University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Pilly', 'Initials': 'P', 'LastName': 'Chillo', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Paniagua', 'Affiliation': 'Barrio Obrero Hospital Asunción, Paraguay.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'ElSayed', 'Affiliation': 'Alzaeim Alazhari University, Khartoum, Sudan.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Dans', 'Affiliation': 'Philippines General Hospital, Manila, Philippines.'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Gondwe-Chunda', 'Affiliation': 'Kamuzu Central Hospital, Malawi.'}, {'ForeName': 'Onkabetse Julia', 'Initials': 'OJ', 'LastName': 'Molefe-Baikai', 'Affiliation': 'University of Botswana, Gaborone, Botswana.'}, {'ForeName': 'Jesus A', 'Initials': 'JA', 'LastName': 'Gonzalez-Hermosillo', 'Affiliation': 'Instituto Nacional de Cardiologia Ignacio Chavez, Mexico City, Mexico.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hakim', 'Affiliation': 'University of Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'Albertino', 'Initials': 'A', 'LastName': 'Damasceno', 'Affiliation': 'Maputo Central Hospital, Maputo, Mozambique.'}, {'ForeName': 'Emmanuel R', 'Initials': 'ER', 'LastName': 'Kamanzi', 'Affiliation': 'University Teaching Hospital of Kigali, Rwanda.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Musuku', 'Affiliation': 'University Teaching Hospital, Lusaka, Zambia.'}, {'ForeName': 'Kairat', 'Initials': 'K', 'LastName': 'Davletov', 'Affiliation': 'Al-Farabi Kazakh National University, Almaty, Kazakhstan.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Connolly', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Bongani M', 'Initials': 'BM', 'LastName': 'Mayosi', 'Affiliation': 'University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.03.018']
3181,32474302,Lower levels of high-density lipoprotein cholesterol are associated with increased cardiovascular events in patients with acute coronary syndrome.,"BACKGROUND AND AIMS


This study aimed to elucidate whether high-density lipoprotein cholesterol (HDL-C) at 3-month follow-up for patients receiving contemporary lipid-lowering therapy after acute coronary syndrome (ACS) could predict cardiac events.
METHODS


The HIJ-PROPER study was a multicenter, prospective, randomized trial comparing intensive lipid-lowering therapy (pitavastatin + ezetimibe) and conventional lipid-lowering therapy (pitavastatin monotherapy) after ACS. The entire cohort was divided into three groups according to tertiles of HDL-C levels at 3-month follow-up (Group 1, HDL-C ≤43 mg/dL; Group 2, HDL-C >43, <53.6 mg/dL; Group 3; HDL-C ≥53.6 mg/dL). Baseline characteristics and incidence of the primary endpoint (a composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, unstable angina pectoris, or ischemia-driven revascularization) were compared among the three groups.
RESULTS


The primary endpoint event occurred in 34.8%, 30.1%, and 24.6% of patients in Groups 1, 2, and 3, respectively, and its incidence was significantly higher in Group 1 than in Group 3 (hazard ratio [HR], 1.5; 95% confidence interval [CI], 1.19-1.9; p = 0.001). Irrespective of the treatment regimen, Group 1 had significantly higher rates of the primary endpoint than Group 3 (pitavastatin + ezetimibe therapy: HR, 1.6; 95% CI, 1.12-2.22; p = 0.01 and pitavastatin monotherapy: HR, 1.4; 95% CI, 1.05-1.98; p = 0.02). These trends remained even after adjustment for baseline characteristics and lipid profiles. Multivariate analysis revealed that lower body mass index, prevalence of diabetes mellitus, higher levels of high-sensitivity C reactive protein at baseline, and lower levels of HDL-C at 3-month follow-up were independent predictors of the incidence of primary endpoint.
CONCLUSIONS


Lower levels of HDL-C at 3-month follow-up are independently associated with higher incidence of cardiovascular events in ACS patients receiving contemporary lipid-lowering therapy.",2020,"Irrespective of the treatment regimen, Group 1 had significantly higher rates of the primary endpoint than Group 3 (pitavastatin + ezetimibe therapy: HR, 1.6; 95% CI, 1.12-2.22; p = 0.01 and pitavastatin monotherapy: HR, 1.4; 95% CI, 1.05-1.98; p = 0.02).","['patients with acute coronary syndrome', 'ACS patients receiving contemporary lipid-lowering therapy', 'patients receiving contemporary lipid-lowering therapy after acute coronary syndrome (ACS']","['intensive lipid-lowering therapy (pitavastatin\xa0+\xa0ezetimibe) and conventional lipid-lowering therapy (pitavastatin monotherapy', 'high-density lipoprotein cholesterol (HDL-C']","['Baseline characteristics and incidence of the primary endpoint (a composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, unstable angina pectoris, or ischemia-driven revascularization', 'cardiovascular events', 'lower body mass index, prevalence of diabetes mellitus, higher levels of high-sensitivity C reactive protein at baseline, and lower levels of HDL-C']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}]","[{'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}, {'cui': 'C1101838', 'cui_str': 'pitavastatin'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0231255', 'cui_str': 'Decreased body mass index'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}]",,0.0661322,"Irrespective of the treatment regimen, Group 1 had significantly higher rates of the primary endpoint than Group 3 (pitavastatin + ezetimibe therapy: HR, 1.6; 95% CI, 1.12-2.22; p = 0.01 and pitavastatin monotherapy: HR, 1.4; 95% CI, 1.05-1.98; p = 0.02).","[{'ForeName': 'Mayui', 'Initials': 'M', 'LastName': 'Nakazawa', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan.""}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Arashi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan. Electronic address: arashi.hiroyuki@twmu.ac.jp.""}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Yamaguchi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan.""}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ogawa', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan.""}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Hagiwara', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan.""}]",Atherosclerosis,['10.1016/j.atherosclerosis.2020.05.005']
3182,32484534,"Effect of C-Reactive Protein-Guided Antibiotic Treatment Duration, 7-Day Treatment, or 14-Day Treatment on 30-Day Clinical Failure Rate in Patients With Uncomplicated Gram-Negative Bacteremia: A Randomized Clinical Trial.","Importance


Antibiotic overuse drives antibiotic resistance. Gram-negative bacteremia is a common infection that results in substantial antibiotic use.
Objective


To compare the clinical effectiveness of C-reactive protein (CRP)-guided, 7-day, and 14-day antibiotic durations 30, 60, and 90 days after treatment initiation.
Design, Setting, and Participants


Multicenter, noninferiority, point-of-care randomized clinical trial including adults hospitalized with gram-negative bacteremia conducted in 3 Swiss tertiary care hospitals between April 2017 and May 2019, with follow-up until August 2019. Patients and physicians were blinded between randomization and antibiotic discontinuation. Adults (aged ≥18 years) were eligible for randomization on day 5 (±1 d) of microbiologically efficacious therapy for fermenting, gram-negative bacteria in blood culture(s) if they were afebrile for 24 hours without evidence for complicated infection (eg, abscess) or severe immunosuppression.
Intervention


Randomization in a 1:1:1 ratio to an individualized CRP-guided antibiotic treatment duration (discontinuation once CRP declined by 75% from peak; n = 170), fixed 7-day treatment duration (n = 169), or fixed 14-day treatment duration (n = 165).
Main Outcomes and Measures


The primary outcome was the clinical failure rate at day 30, defined as the presence of at least 1 of the following, with a non-inferiority margin of 10%: recurrent bacteremia, local suppurative complication, distant complication (growth of the same organism causing the initial bacteremia), restarting gram-negative-directed antibiotic therapy due to clinical worsening suspected to be due to the initial organism, or death due to any cause. Secondary outcomes included the clinical failure rate on day 90 of follow-up.
Results


Among 504 patients randomized (median [interquartile range] age, 79 [68-86] years; 306 of 503 [61%] were women), 493 (98%) completed 30-day follow-up and 448 (89%) completed 90-day follow-up. Median antibiotic duration in the CRP group was 7 (interquartile range, 6-10; range, 5-28) days; 34 of the 164 patients (21%) who completed the 30-day follow-up had protocol violations related to treatment assignment. The primary outcome occurred in 4 of 164 (2.4%) patients in the CRP group, 11 of 166 (6.6%) in the 7-day group, and 9 of 163 (5.5%) in the 14-day group (difference in CRP vs 14-day group, -3.1% [1-sided 97.5% CI, -∞ to 1.1]; P < .001; difference in 7-day vs 14-day group, 1.1% [1-sided 97.5% CI, -∞ to 6.3]; P < .001). By day 90, clinical failure occurred in 10 of 143 patients (7.0%) in the CRP group, 16 of 151 (10.6%) in the 7-day group, and 16 of 153 (10.5%) in the 14-day group.
Conclusions and Relevance


Among adults with uncomplicated gram-negative bacteremia, 30-day rates of clinical failure for CRP-guided antibiotic treatment duration and fixed 7-day treatment were noninferior to fixed 14-day treatment. However, interpretation is limited by the large noninferiority margin compared with the low observed event rate, as well as low adherence and wide range of treatment durations in the CRP-guided group.
Trial Registration


ClinicalTrials.gov Identifier: NCT03101072.",2020,"The primary outcome occurred in 4 of 164 (2.4%) patients in the CRP group, 11 of 166 (6.6%) in the 7-day group, and 9 of 163 (5.5%) in the 14-day group (difference in CRP vs 14-day group, -3.1% [1-sided 97.5% CI, -∞ to 1.1]; P < .001; difference in 7-day vs 14-day group, 1.1% [1-sided 97.5% CI, -∞ to 6.3]; P < .001).","['Adults (aged ≥18 years) were eligible for randomization on day 5 (±1 d) of microbiologically efficacious therapy for fermenting, gram-negative bacteria in blood culture(s) if they were afebrile for 24 hours without evidence for complicated infection (eg, abscess) or severe immunosuppression', 'With Uncomplicated Gram-Negative Bacteremia', 'Patients', 'adults hospitalized with gram-negative bacteremia conducted in 3 Swiss tertiary care hospitals between April 2017 and May 2019, with follow-up until August 2019', 'adults with uncomplicated gram-negative bacteremia, 30-day rates of clinical failure for CRP-guided antibiotic treatment duration and fixed 7-day treatment', '504 patients randomized (median [interquartile range] age, 79 [68-86] years; 306 of 503 [61%] were women), 493 (98%) completed 30-day follow-up and 448 (89%) completed 90-day follow-up']","['individualized CRP-guided antibiotic treatment duration (discontinuation once CRP', 'C-reactive protein (CRP)-guided, 7-day, and 14-day antibiotic durations', 'C-Reactive Protein-Guided Antibiotic']","['clinical failure rate', 'Median antibiotic duration', 'clinical failure rate on day 90 of follow-up', '30-Day Clinical Failure Rate', 'recurrent bacteremia, local suppurative complication, distant complication (growth of the same organism causing the initial bacteremia), restarting gram-negative-directed antibiotic therapy due to clinical worsening suspected to be due to the initial organism, or death due to any cause', 'clinical failure']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018150', 'cui_str': 'Gram-negative bacterium'}, {'cui': 'C0200949', 'cui_str': 'Blood culture'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C3160894', 'cui_str': 'Complicated infection'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0744471', 'cui_str': 'Gram-negative bacteremia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C3203360', 'cui_str': 'Suppuration'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0029235', 'cui_str': 'Organism'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",504.0,0.162586,"The primary outcome occurred in 4 of 164 (2.4%) patients in the CRP group, 11 of 166 (6.6%) in the 7-day group, and 9 of 163 (5.5%) in the 14-day group (difference in CRP vs 14-day group, -3.1% [1-sided 97.5% CI, -∞ to 1.1]; P < .001; difference in 7-day vs 14-day group, 1.1% [1-sided 97.5% CI, -∞ to 6.3]; P < .001).","[{'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'von Dach', 'Affiliation': 'Faculty of Medicine, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Werner C', 'Initials': 'WC', 'LastName': 'Albrich', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, Cantonal Hospital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Brunel', 'Affiliation': 'Infectious Diseases Service, University Hospital, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Prendki', 'Affiliation': 'Faculty of Medicine, Division of Internal Medicine of the Aged, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Clémence', 'Initials': 'C', 'LastName': 'Cuvelier', 'Affiliation': 'Faculty of Medicine, Division of Internal Medicine of the Aged, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Flury', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, Cantonal Hospital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Angèle', 'Initials': 'A', 'LastName': 'Gayet-Ageron', 'Affiliation': 'Faculty of Medicine, Clinical Research Center, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Huttner', 'Affiliation': 'Faculty of Medicine, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Kohler', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, Cantonal Hospital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Lemmenmeier', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, Cantonal Hospital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Shawna', 'Initials': 'S', 'LastName': 'McCallin', 'Affiliation': 'Faculty of Medicine, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Rossel', 'Affiliation': 'Department of Internal Medicine, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Harbarth', 'Affiliation': 'Faculty of Medicine, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Kaiser', 'Affiliation': 'Faculty of Medicine, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Bochud', 'Affiliation': 'Infectious Diseases Service, University Hospital, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Huttner', 'Affiliation': 'Faculty of Medicine, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.'}]",JAMA,['10.1001/jama.2020.6348']
3183,32484552,Effect of Suvorexant vs Placebo on Total Daytime Sleep Hours in Shift Workers: A Randomized Clinical Trial.,"Importance


Many shift workers have difficulty sleeping during the daytime owing to an inappropriately timed circadian drive for wakefulness.
Objective


To determine whether a dual hypocretin receptor antagonist would enable shift workers to have more daytime sleep.
Design, Setting, and Participants


This double-blind, placebo-controlled randomized clinical trial included 2 weeks of baseline data and 3 weeks of intervention data, from March 2016 to December 2018. Individuals were recruited through poster advertisements in the broader San Francisco Bay area in California. From an initial voluntary recruitment cohort of 38 shift workers, 19 individuals with self-reported difficulty sleeping during the daytime following night work shift were included. Data were analyzed from Janaury to March 2019.
Interventions


1 week of 10 mg suvorexant or placebo, titrated upward to 20 mg suvorexant or placebo for 2 additional weeks.
Main Outcomes and Measures


Objective (ie, actigraphy) and subjective (ie, sleep logs) measures of sleep.
Results


Among 19 participants who completed the study (mean [SD] age, 37.7 [11.1] years; 13 [68%] men), 8 participants (42%) were assigned to the suvorexant group and 11 participants (58%) were assigned to the placebo group. Compared with individuals in the placebo group, individuals in the suvorexant group increased their objective total sleep time by a mean (SE) of 1.04 (0.53) hours (P = .05) at the end of 1 week of 10-mg doses and by 2.16 (0.75) hours (P = .004) by the end of the 2 weeks of 20-mg doses. Subjective sleep was similarly improved as, compared with the placebo group, individuals in the suvorexant group increased their subjective total sleep time by a mean (SE) of 2.08 (0.47) hours (P < .001) at the end of 1 week of 10-mg doses and by 2.97 (0.56) hours (P < .001) by the end of the 2 weeks of 20-mg doses. Physician ratings of daytime sleep aligned with these measures, as there was no change in the placebo group and a much improved change in the suvorexant group. No adverse events were reported in the suvorexant group.
Conclusions and Relevance


This pilot study found that the use of a dual hypocretin receptor antagonist in shift workers under real-world conditions resulted in more than 2 extra hours of daytime sleep per episode. Future research should confirm this pilot finding in a larger sample size and examine whether, over the long term, use of this medication has a concomitant improvement in medical and psychiatric health as well as workplace performance and safety.
Trial Registration


ClinicalTrials.gov Identifier: NCT02491788.",2020,"No adverse events were reported in the suvorexant group.
","['19 participants who completed the study (mean [SD] age, 37.7 [11.1] years; 13 [68%] men), 8 participants (42%) were assigned to the suvorexant group and 11 participants (58', 'Shift Workers', '38 shift workers, 19 individuals with self-reported difficulty sleeping during the daytime following night work shift were included', 'Individuals were recruited through poster advertisements in the broader San Francisco Bay area in California']","['placebo', 'suvorexant or placebo, titrated upward to 20 mg suvorexant or placebo', 'Suvorexant vs Placebo', 'dual hypocretin receptor antagonist']","['Subjective sleep', 'objective total sleep time', 'ie, sleep logs) measures of sleep', 'Total Daytime Sleep Hours', 'subjective total sleep time', 'adverse events', 'Physician ratings of daytime sleep', 'Measures\n\n\nObjective (ie, actigraphy) and subjective ']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C3179535', 'cui_str': 'suvorexant'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0425104', 'cui_str': 'Shift worker'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376675', 'cui_str': 'Posters'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C3203003', 'cui_str': 'Bays'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0006754', 'cui_str': 'California'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3179535', 'cui_str': 'suvorexant'}, {'cui': 'C1282911', 'cui_str': 'Upward'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1113688', 'cui_str': 'Orexin'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4075948', 'cui_str': 'Sleeps during day'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}]",,0.328829,"No adverse events were reported in the suvorexant group.
","[{'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Zeitzer', 'Affiliation': 'Stanford Center for Sleep Sciences And Medicine, Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Joyce', 'Affiliation': 'Stanford Center for Sleep Sciences And Medicine, Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'McBean', 'Affiliation': 'Stanford Center for Sleep Sciences And Medicine, Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California.'}, {'ForeName': 'Yvonne L', 'Initials': 'YL', 'LastName': 'Quevedo', 'Affiliation': 'Mental Illness Research, Education, and Clinical Center, VA Palo Alto Health Care System, Palo Alto, California.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Hernandez', 'Affiliation': 'Mental Illness Research, Education, and Clinical Center, VA Palo Alto Health Care System, Palo Alto, California.'}, {'ForeName': 'Jon-Erik', 'Initials': 'JE', 'LastName': 'Holty', 'Affiliation': 'Pulmonary, Critical Care, and Sleep Medicine Section, VA Palo Alto Health Care System, Palo Alto, California.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.6614']
3184,32481325,The success of opening concurrent chronic total occlusion lesion to improve cardiac function trial in patients with multi-vessel disease (SOS-moral): Study protocol of a prospective multicenter study.,"AIMS


The purpose of the present trial is to determine whether opening co-existing chronic total occlusions (CTOs) using percutaneous coronary interventions (PCIs) improves cardiac function in patients with multi-vessel disease (MVD). Patients with MVD are defined as having at least one additional major vessel exhibiting no less than 75% stenosis combined with the presence of a CTO artery.
METHODS AND RESULTS


Patients will be prospectively recruited who meet the following criteria:Patients presenting with no necrosis of myocardial tissue in the territory of the CTO will be excluded. Recruited patients will be randomized into 2 groups: those undergoing PCI of only the non-CTO artery (non-CTO PCI group), and those undergoing PCI of the non-CTO artery concurrently with the CTO artery (CTO-PCI group). The primary outcome will be the change in cardiac function evaluated via CMR at a 12-month of follow-up appointment, which will be compared to a baseline measurement. Secondary outcomes include occurrence of major cardiac events, CMR-assessed myocardial viability in the CTO-supplied territory, and quality of life assessed by Seattle angina questionnaire, Patient Health Questionnaire 9 and Generalized Anxiety Disorder Scale-7 after 12-month follow-up.
CONCLUSION


The SOS-moral trial will provide data necessary to determine whether to open concurrent CTOs among MVD patients with CMR-detected necrotic myocardial tissue.",2020,"Recruited patients will be randomized into 2 groups: those undergoing PCI of only the non-CTO artery (non-CTO PCI group), and those undergoing PCI of the non-CTO artery concurrently with the CTO artery (CTO-PCI group).","['patients with multi-vessel disease (MVD', 'Patients will be prospectively recruited who meet the following criteria:Patients presenting with no necrosis of myocardial tissue in the territory of the CTO will be excluded', 'patients with multi-vessel disease (SOS-moral', 'MVD patients with CMR-detected necrotic myocardial tissue']","['percutaneous coronary interventions (PCIs', 'PCI of only the non-CTO artery (non-CTO PCI group), and those undergoing PCI of the non-CTO artery concurrently with the CTO artery (CTO-PCI group', 'opening co-existing chronic total occlusions (CTOs']","['change in cardiac function evaluated via CMR', 'cardiac function', 'occurrence of major cardiac events, CMR-assessed myocardial viability in the CTO-supplied territory, and quality of life assessed by Seattle angina questionnaire, Patient Health Questionnaire 9 and Generalized Anxiety Disorder Scale-7']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0027061', 'cui_str': 'Cardiac muscle (tissue)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C4225412', 'cui_str': 'Spondylo-ocular syndrome'}, {'cui': 'C0026531', 'cui_str': 'Morality'}, {'cui': 'C0006802', 'cui_str': 'Cameroon'}, {'cui': 'C0442726', 'cui_str': 'Detected'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0006802', 'cui_str': 'Cameroon'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0643313,"Recruited patients will be randomized into 2 groups: those undergoing PCI of only the non-CTO artery (non-CTO PCI group), and those undergoing PCI of the non-CTO artery concurrently with the CTO artery (CTO-PCI group).","[{'ForeName': 'Jinfan', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Department of Cardiology.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Zuo', 'Affiliation': 'Department of Community Health Research.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, Beijing Anzhen Hospital.'}, {'ForeName': 'Mingduo', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology.'}, {'ForeName': 'Dongfeng', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiology.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Radiology, Beijing Friendship Hospital.'}, {'ForeName': 'Hongzhi', 'Initials': 'H', 'LastName': 'Mi', 'Affiliation': 'Department of Nuclear Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing.'}, {'ForeName': 'Xueyao', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology.'}, {'ForeName': 'Rongchong', 'Initials': 'R', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Dalian Medical University, Dalian.'}, {'ForeName': 'Xiantao', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': 'Department of Cardiology.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020349']
3185,32481332,Standardization of rehabilitation program for post-apoplectic limb spasm treated by Tongjing Tiaoxing tuina and scalp acupuncture with physical therapy.,"BACKGROUND


Tong Jing Tiao Xing tuina (TJTX) is a Chinese massage method. Excising with scalp acupuncture (ESA) is a treatment combining scalp electroacupuncture with physical therapy (PT), and yinao fujian formula (YNFJ) is a Chinese oral herbal granule medicine. The combination of the 3 methods is called the ""Zhishen Tiaoxing"" (ZSTX) rehabilitation program, which is used as an alternative of limb spasm after stroke. There is little available evidence demonstrating its safety and efficacy.
METHODS


This will be a subject-blind, randomized controlled trial conducted in 3 medical centers. It will strictly follow the Standards for Reporting Interventions in Clinical Trials of Acupuncture, 2010. We will recruit 316 patients with limb spasm after stroke, 200 from the Affiliated Hospital of Changchun University of Chinese Medicine, Changchun, China, 80 from the Second Affiliated Hospital of Heilongjiang University of Chinese medicine, Harbin, China, and 36 from Huashan Hospital of Fudan University, Shanghai, China. A block randomization sequence stratified by centers will be generated using SAS Version 9.2 software (SAS Institute, Cary, NC, USA), which was performed at the Guangdong Provincial Hospital of Chinese Medicine's Key Unit of Methodology in Clinical Research. The treatment group is treated with TJTX (once a day), ESA (once a day), and oral YNFJ (twice a day). The control group will be treated with PT. Two groups of patients will be treated 5 sessions a week for 4 weeks, and there will be 6-month follow-up. The outcome evaluators will be blinded to patient grouping. The primary outcome will be modified Ashworth scales. The secondary outcome indexes will be the simplified Fugl-Meyer assessment scale, surface electromyogram root mean square value, modified Barthel index, stroke-specific quality of life scale, health scale of traditional Chinese medicine, visual analogue scale (VAS), and the Hamilton depression scale.
DISCUSSION


The Randomized Controlled Trial (RCT) mainly aim to evaluate the effectiveness and safety of traditional Chinese medicine rehabilitation program, by comparing the treatment of ZSTX with the PT for the treatment of limb spasm after stroke.
TRIAL REGISTRATION


Chinese Clinical Trial Registry: ChiCTR 1900024255. Registered on July 3, 2019.",2020,"The combination of the 3 methods is called the ""Zhishen Tiaoxing"" (ZSTX) rehabilitation program, which is used as an alternative of limb spasm after stroke.","['3 medical centers', 'limb spasm after stroke', '316 patients with limb spasm after stroke, 200 from the Affiliated Hospital of Changchun University of Chinese Medicine, Changchun, China, 80 from the Second Affiliated Hospital of Heilongjiang University of Chinese medicine, Harbin, China, and 36 from Huashan Hospital of Fudan University, Shanghai, China']","['scalp electroacupuncture with physical therapy (PT), and yinao fujian formula (YNFJ', 'PT', 'scalp acupuncture (ESA', 'oral YNFJ', 'Tongjing Tiaoxing tuina and scalp acupuncture with physical therapy', 'ZSTX', 'TJTX', 'ESA', 'Tong Jing Tiao Xing tuina (TJTX', 'traditional Chinese medicine rehabilitation program']","['simplified Fugl-Meyer assessment scale, surface electromyogram root mean square value, modified Barthel index, stroke-specific quality of life scale, health scale of traditional Chinese medicine, visual analogue scale (VAS), and the Hamilton depression scale', 'modified Ashworth scales']","[{'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0026821', 'cui_str': 'Cramp'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205436', 'cui_str': 'Second'}]","[{'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0183964', 'cui_str': 'Tong'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}]",316.0,0.0846612,"The combination of the 3 methods is called the ""Zhishen Tiaoxing"" (ZSTX) rehabilitation program, which is used as an alternative of limb spasm after stroke.","[{'ForeName': 'Qiongshuai', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Acupuncture and Tuina, Changchun University of Chinese Medicine.'}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Tuina, Traditional Chinese Medicine Hospital of Jilin Province.'}, {'ForeName': 'Guangcheng', 'Initials': 'G', 'LastName': 'Ji', 'Affiliation': 'Department of Rehabilitation, The Third Affiliated Hospital of Changchun University of Chinese Medicine, Changchun.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Cao', 'Affiliation': 'Department of Acupuncture, The 1st affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, China.'}, {'ForeName': 'Guanyu', 'Initials': 'G', 'LastName': 'Hu', 'Affiliation': 'Department of Acupuncture and Tuina, Changchun University of Chinese Medicine.'}, {'ForeName': 'Deyu', 'Initials': 'D', 'LastName': 'Cong', 'Affiliation': 'Department of Tuina, Traditional Chinese Medicine Hospital of Jilin Province.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Acupuncture and Tuina, Changchun University of Chinese Medicine.'}, {'ForeName': 'Bailin', 'Initials': 'B', 'LastName': 'Song', 'Affiliation': 'Department of Acupuncture and Tuina, Changchun University of Chinese Medicine.'}]",Medicine,['10.1097/MD.0000000000020368']
3186,32481334,Effect of fire needle therapy on mild-moderate benign prostatic hyperplasia: Protocol for a randomized controlled pilot trial.,"BACKGROUND


Benign prostatic hyperplasia (BPH) is the most common non-cancerous disease of the prostate and leads to lower urinary tract symptoms in middle-aged and elderly males. Fire needle therapy could improve the lower urinary tract symptoms associated with mild-moderate BPH in clinical practice. The aim of the present pilot study is to assess the preliminary effects of fire needle therapy on mild-moderate BPH.
METHODS


The present study is a prospective parallel randomized controlled pilot trial. A total of 60 eligible participants will be randomly assigned to a treatment or control group at a 1:1 ratio. The treatment group will receive fire needle therapy and the control group will receive watchful waiting with lifestyle advice and education regarding BPH. Participants will receive intervention for 4 weeks, with a follow-up period of 4 additional weeks. Adverse events will be recorded to assess the safety and tolerability of fire needle therapy for mild-moderate BPH. The primary outcome will be the change in the International Prostate Symptom Score. The secondary outcomes will include the change in the mean number of nightly urinations, the maximum urinary flow rate, the average flow rate, and the prostate volume as measured by a B-mode ultrasound device. All outcome measures will be observed at baseline and at 4 and 8 weeks following the beginning of treatment.
DISCUSSION


The present study will provide evidence of the preliminary effects of fire needle therapy on mild-moderate BPH and indicate an optimal sample size for future studies.",2020,"The secondary outcomes will include the change in the mean number of nightly urinations, the maximum urinary flow rate, the average flow rate, and the prostate volume as measured by a B-mode ultrasound device.","['mild-moderate benign prostatic hyperplasia', 'Benign prostatic hyperplasia (BPH', '60 eligible participants', 'mild-moderate BPH', 'middle-aged and elderly males']","['fire needle therapy', 'fire needle therapy and the control group will receive watchful waiting with lifestyle advice and education regarding BPH', 'Fire needle therapy']","['change in the mean number of nightly urinations, the maximum urinary flow rate, the average flow rate, and the prostate volume as measured by a B-mode ultrasound device', 'change in the International Prostate Symptom Score', 'safety and tolerability']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0014007', 'cui_str': 'Dismissed from job'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C1276791', 'cui_str': 'Education assistance'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0429783', 'cui_str': 'Urinary flow rate'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1302166', 'cui_str': 'B mode ultrasound'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",60.0,0.0994786,"The secondary outcomes will include the change in the mean number of nightly urinations, the maximum urinary flow rate, the average flow rate, and the prostate volume as measured by a B-mode ultrasound device.","[{'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation.'}, {'ForeName': 'Yun-Qing', 'Initials': 'YQ', 'LastName': 'Xun', 'Affiliation': 'Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation.'}, {'ForeName': 'Gui-Ling', 'Initials': 'GL', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation.'}, {'ForeName': 'Lin-Peng', 'Initials': 'LP', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation.'}, {'ForeName': 'Lian-Cheng', 'Initials': 'LC', 'LastName': 'Jia', 'Affiliation': 'Department of Urology.'}, {'ForeName': 'Wei-Guang', 'Initials': 'WG', 'LastName': 'Li', 'Affiliation': 'Department of Urology.'}, {'ForeName': 'Xue-Mei', 'Initials': 'XM', 'LastName': 'Liu', 'Affiliation': 'Ultrasound Diagnostics Division, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hui-Lin', 'Initials': 'HL', 'LastName': 'Liu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation.'}, {'ForeName': 'Jing-Qing', 'Initials': 'JQ', 'LastName': 'Sun', 'Affiliation': 'Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation.'}]",Medicine,['10.1097/MD.0000000000020376']
3187,32481345,Isokinetic back training is more effective than core stabilization training on pain intensity and sports performances in football players with chronic low back pain: A randomized controlled trial.,"BACKGROUND


Isokinetic training (IKT) and core stabilization training (CST) are commonly used for balance training in musculoskeletal conditions. The knowledge about the effective implementation of these training protocols on sports performances in university football players with chronic low back pain (LBP) is lacking.
OBJECTIVE


To find and compare the effects of IKT and CST on sports performances in university football players with chronic LBP.
DESIGN


Randomized, double-blinded controlled study.
SETTING


University hospital.
PARTICIPANTS


Sixty LBP participants divided into isokinetic group (IKT; n = 20), core stabilization group (CST; n = 20), and the control group (n = 20) and received respected exercises for 4 weeks.
OUTCOME MEASURES


Clinical (pain intensity and player wellness) and sports performances (40 m sprint, 4 × 5 m sprint, submaximal shuttle running, counter movement jump, and squat jump) scores were measured at baseline, after 4 weeks, 8 weeks, and 3 months.
RESULTS


Four weeks following training IKT group shows more significant changes in pain intensity and player wellness scores than CST and control groups (P ≤ .001). Sports performance variables (40 m sprint, 4 × 5 m sprint, submaximal shuttle running, counter movement jump and squat jump) scores also show significant improvement in IKT group than the other 2 groups (P ≤ .001).
CONCLUSION


This study suggests that training through IKT improves pain intensity and sports performances than CST in university football players with chronic LBP.",2020,Four weeks following training IKT group shows more significant changes in pain intensity and player wellness scores than CST and control groups (P ≤ .001).,"['university football players with chronic low back pain (LBP', 'Sixty LBP participants divided into', 'football players with chronic low back pain', 'university football players with chronic LBP', 'University hospital']","['IKT and CST', 'core stabilization training', 'IKT', 'Isokinetic back training', 'Isokinetic training (IKT) and core stabilization training (CST', 'isokinetic group (IKT; n\u200a=\u200a20), core stabilization group (CST; n\u200a=\u200a20), and the control group (n\u200a=\u200a20) and received respected exercises for 4 weeks']","['Clinical (pain intensity and player wellness) and sports performances (40 m sprint, 4 × 5 m sprint, submaximal shuttle running, counter movement jump, and squat jump) scores', 'submaximal shuttle running, counter movement jump and squat jump) scores', 'pain intensity and sports performances', 'pain intensity and player wellness scores']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0871966', 'cui_str': 'Sports Performance'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0677601', 'cui_str': 'Counter'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.126822,Four weeks following training IKT group shows more significant changes in pain intensity and player wellness scores than CST and control groups (P ≤ .001).,"[{'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Nambi', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia.'}, {'ForeName': 'Walid Kamal', 'Initials': 'WK', 'LastName': 'Abdelbasset', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia.'}, {'ForeName': 'Bader A', 'Initials': 'BA', 'LastName': 'Alqahtani', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia.'}, {'ForeName': 'Saud M', 'Initials': 'SM', 'LastName': 'Alrawaili', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Abodonya', 'Affiliation': 'Anesthesia and Intensive Care Department, Faculty of Medicine, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Ayman K', 'Initials': 'AK', 'LastName': 'Saleh', 'Affiliation': 'College of Medicine, Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia.'}]",Medicine,['10.1097/MD.0000000000020418']
3188,32460511,"Ultra-low-dose CT-guided lung biopsy in clinic: radiation dose, accuracy, image quality, and complication rate.","BACKGROUND


Computed tomography (CT)-guided percutaneous lung biopsy is usually performed by helical scanning. However, there are no studies on radiation dose, diagnostic accuracy, image quality, and complications based on axial scan mode.
PURPOSE


To determine radiation dose, accuracy, image quality, and complication rate following an ultra-low-dose (ULD) protocol for CT-guided lung biopsy in clinic.
MATERIAL AND METHODS


A total of 105 patients were enrolled to receive CT-guided lung biopsy. The use of an ULD protocol (axial scan) for CT-guided biopsy was initiated. Patients were randomly assigned to axial mode (Group A) and conventional helical mode (Group B) CT groups. 64-slice CT was performed for CT-guided pulmonary biopsy with an 18-G coaxial cutting biopsy needle. The radiation dose, accuracy, image quality, and complication rate were measured.
RESULTS


Ninety-seven patients were selected for the final phase of the study. There was no significant difference between the two groups for pulmonary nodule characteristics ( P  > 0.05). The mean effective dose in group A (0.077 ± 0.010 mSv) was significantly reduced relative to group B (0.653 ± 0.177 mSv,  P  < 0.001). There was no significant difference in accuracy, image quality, and complication rate ( P  > 0.050) between the two modes.
CONCLUSION


An ULD protocol for CT-guided lung nodule biopsy yields a reduction in the radiation dose without significant change in the accuracy, image quality, and complication rate relative to the conventional helical mode scan.",2020,"There was no significant difference in accuracy, image quality, and complication rate ( P  > 0.050) between the two modes.
","['Ninety-seven patients were selected for the final phase of the study', '105 patients were enrolled to receive']","['Computed tomography (CT)-guided percutaneous lung biopsy', 'ultra-low-dose (ULD) protocol for CT-guided lung biopsy', 'CT-guided pulmonary biopsy with an 18-G coaxial cutting biopsy needle', 'CT-guided lung biopsy', 'ULD protocol (axial scan', 'Ultra-low-dose CT-guided lung biopsy', 'conventional helical mode (Group B']","['accuracy, image quality, and complication rate relative', 'pulmonary nodule characteristics', 'accuracy, image quality, and complication rate', 'radiation dose, accuracy, image quality, and complication rate']","[{'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319547', 'cui_str': '105'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0189485', 'cui_str': 'Biopsy of lung'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456637', 'cui_str': '18G'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0181960', 'cui_str': 'Biopsy needle'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0034079', 'cui_str': 'Nodule of lung'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",105.0,0.0266202,"There was no significant difference in accuracy, image quality, and complication rate ( P  > 0.050) between the two modes.
","[{'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Liang', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, PR China.""}, {'ForeName': 'Yonghao', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, PR China.""}, {'ForeName': 'Chenguang', 'Initials': 'C', 'LastName': 'Guo', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, PR China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, PR China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Shang', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, PR China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, PR China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Niu', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, PR China.""}]","Acta radiologica (Stockholm, Sweden : 1987)",['10.1177/0284185120917622']
3189,32466729,"Computable Phenotype Implementation for a National, Multicenter Pragmatic Clinical Trial: Lessons Learned From ADAPTABLE.","BACKGROUND


Many large-scale cardiovascular clinical trials are plagued with escalating costs and low enrollment. Implementing a computable phenotype, which is a set of executable algorithms, to identify a group of clinical characteristics derivable from electronic health records or administrative claims records, is essential to successful recruitment in large-scale pragmatic clinical trials. This methods paper provides an overview of the development and implementation of a computable phenotype in ADAPTABLE (Aspirin Dosing: a Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness)-a pragmatic, randomized, open-label clinical trial testing the optimal dose of aspirin for secondary prevention of atherosclerotic cardiovascular disease events.
METHODS AND RESULTS


A multidisciplinary team developed and tested the computable phenotype to identify adults ≥18 years of age with a history of atherosclerotic cardiovascular disease without safety concerns around using aspirin and meeting trial eligibility criteria. Using the computable phenotype, investigators identified over 650 000 potentially eligible patients from the 40 participating sites from Patient-Centered Outcomes Research Network-a network of Clinical Data Research Networks, Patient-Powered Research Networks, and Health Plan Research Networks. Leveraging diverse recruitment methods, sites enrolled 15 076 participants from April 2016 to June 2019. During the process of developing and implementing the ADAPTABLE computable phenotype, several key lessons were learned. The accuracy and utility of a computable phenotype are dependent on the quality of the source data, which can be variable even with a common data model. Local validation and modification were required based on site factors, such as recruitment strategies, data quality, and local coding patterns. Sustained collaboration among a diverse team of researchers is needed during computable phenotype development and implementation.
CONCLUSIONS


The ADAPTABLE computable phenotype served as an efficient method to recruit patients in a multisite pragmatic clinical trial. This process of development and implementation will be informative for future large-scale, pragmatic clinical trials. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02697916.",2020,"Local validation and modification were required based on site factors, such as recruitment strategies, data quality, and local coding patterns.","['Leveraging diverse recruitment methods, sites enrolled 15 076 participants from April 2016 to June 2019', '650 000 potentially eligible patients from the 40 participating sites from Patient-Centered Outcomes Research Network-a network of Clinical Data Research Networks, Patient-Powered Research Networks, and Health Plan Research Networks', 'adults ≥18 years of age with a history of atherosclerotic cardiovascular disease without safety concerns around using aspirin and meeting trial eligibility criteria']","['Aspirin', 'aspirin']",[],"[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C3844101', 'cui_str': '650'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}, {'cui': 'C0018727', 'cui_str': 'Health Planning'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}]",[],15076.0,0.152651,"Local validation and modification were required based on site factors, such as recruitment strategies, data quality, and local coding patterns.","[{'ForeName': 'Faraz S', 'Initials': 'FS', 'LastName': 'Ahmad', 'Affiliation': 'Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL (F.S.A.).'}, {'ForeName': 'Iben M', 'Initials': 'IM', 'LastName': 'Ricket', 'Affiliation': 'Louisiana Public Health Institute, New Orleans (I.M.R.).'}, {'ForeName': 'Bradley G', 'Initials': 'BG', 'LastName': 'Hammill', 'Affiliation': 'Duke University School of Medicine, Durham, NC (B.G.H., M.T.R., W.S.J.).'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Eskenazi', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (B.G.H., L.E., H.R., L.H.C., M.T.R., W.S.J.).'}, {'ForeName': 'Holly R', 'Initials': 'HR', 'LastName': 'Robertson', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (B.G.H., L.E., H.R., L.H.C., M.T.R., W.S.J.).'}, {'ForeName': 'Lesley H', 'Initials': 'LH', 'LastName': 'Curtis', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (B.G.H., L.E., H.R., L.H.C., M.T.R., W.S.J.).'}, {'ForeName': 'Cecilia D', 'Initials': 'CD', 'LastName': 'Dobi', 'Affiliation': 'Department of Clinical Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA (C.D.D.).'}, {'ForeName': 'Saket', 'Initials': 'S', 'LastName': 'Girotra', 'Affiliation': 'University of Iowa Carver College of Medicine, Iowa City (S.G.).'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Haynes', 'Affiliation': 'Scientific Affairs, HealthCore, Inc., Wilmington, DE (K.H.).'}, {'ForeName': 'Jorge R', 'Initials': 'JR', 'LastName': 'Kizer', 'Affiliation': 'Cardiology Section, San Francisco Veterans Affairs Health Care System, CA (J.R.K.).'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Kripalani', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Veterans Health Administration-Tennessee Valley Healthcare System Geriatric Research Education Clinical Center, Health Services Research and Development Center, Nashville, TN (S.K., C.L.R.).'}, {'ForeName': 'Mathew T', 'Initials': 'MT', 'LastName': 'Roe', 'Affiliation': 'Duke University School of Medicine, Durham, NC (B.G.H., M.T.R., W.S.J.).'}, {'ForeName': 'Christianne L', 'Initials': 'CL', 'LastName': 'Roumie', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Veterans Health Administration-Tennessee Valley Healthcare System Geriatric Research Education Clinical Center, Health Services Research and Development Center, Nashville, TN (S.K., C.L.R.).'}, {'ForeName': 'Russ', 'Initials': 'R', 'LastName': 'Waitman', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, KS (R.W.).'}, {'ForeName': 'W Schuyler', 'Initials': 'WS', 'LastName': 'Jones', 'Affiliation': 'Duke University School of Medicine, Durham, NC (B.G.H., M.T.R., W.S.J.).'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Weiner', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medicine, New York Presbyterian-Weill Cornell Campus, New York (M.G.W.).'}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.119.006292']
3190,32472620,Acute Alcohol Intake Produces Widespread Decreases in Cortical Resting Signal Variability in Healthy Social Drinkers.,"BACKGROUND


Acute alcohol intoxication has wide-ranging neurobehavioral effects on psychomotor, attentional, inhibitory, and memory-related cognitive processes. These effects are mirrored in disruption of neural metabolism, functional activation, and functional network coherence. Metrics of intraregional neural dynamics such as regional signal variability (RSV) and brain entropy (BEN) may capture unique aspects of neural functional capacity in healthy and clinical populations; however, alcohol's influence on these metrics is unclear. The present study aimed to elucidate the influence of acute alcohol intoxication on RSV and to clarify these effects with subsequent BEN analyses.
METHODS


26 healthy adults between 25 and 45 years of age (65.4% women) participated in 2 counterbalanced sessions. In one, participants consumed a beverage containing alcohol sufficient to produce a breath alcohol concentration of 0.08 g/dl. In the other, they consumed a placebo beverage. Approximately 35 minutes after beverage consumption, participants completed a 9-minute resting-state fMRI scan. Whole-brain, voxel-wise standard deviation was used to assess RSV, which was compared between sessions. Within clusters displaying alterations in RSV, sample entropy was calculated to assess BEN.
RESULTS


Compared to the placebo, alcohol intake resulted in widespread reductions in RSV in the bilateral middle frontal, right inferior frontal, right superior frontal, bilateral posterior cingulate, bilateral middle temporal, right supramarginal gyri, and bilateral inferior parietal lobule. Within these clusters, significant reductions in BEN were found in the bilateral middle frontal and right superior frontal gyri. No effects were noted in subcortical or cerebellar areas.
CONCLUSIONS


Findings indicate that alcohol intake produces diffuse reductions in RSV among structures associated with attentional processes. Within these structures, signal complexity was also reduced in a subset of frontal regions. Neurobehavioral effects of acute alcohol consumption may be partially driven by disruption of intraregional neural dynamics among regions involved in higher-order cognitive and attentional processes.",2020,"Compared to the placebo, alcohol intake resulted in widespread reductions in RSV in the bilateral middle frontal, right inferior frontal, right superior frontal, bilateral posterior cingulate, bilateral middle temporal, right supramarginal gyri, and bilateral inferior parietal lobule.","['Healthy Social Drinkers', 'healthy and clinical populations', '26 healthy adults between 25 and 45 years of age (65.4% women']","['placebo beverage', 'placebo, alcohol intake']","['BEN', 'disruption of neural metabolism, functional activation, and functional network coherence', 'subcortical or cerebellar areas', 'bilateral middle frontal, right inferior frontal, right superior frontal, bilateral posterior cingulate, bilateral middle temporal, right supramarginal gyri, and bilateral inferior parietal lobule']","[{'cui': 'C0337676', 'cui_str': 'Social drinker'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0376522', 'cui_str': 'Entropy'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate Gyri'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0152304', 'cui_str': 'Inferior parietal lobule structure'}]",26.0,0.111513,"Compared to the placebo, alcohol intake resulted in widespread reductions in RSV in the bilateral middle frontal, right inferior frontal, right superior frontal, bilateral posterior cingulate, bilateral middle temporal, right supramarginal gyri, and bilateral inferior parietal lobule.","[{'ForeName': 'Landrew', 'Initials': 'L', 'LastName': 'Sevel', 'Affiliation': 'From the Osher Center for Integrative Medicine at Vanderbilt, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Stennett', 'Affiliation': 'Center for Pain Research and Behavioral Health, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Schneider', 'Affiliation': 'Center for Pain Research and Behavioral Health, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Bush', 'Affiliation': 'Center for Pain Research and Behavioral Health, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Sara Jo', 'Initials': 'SJ', 'LastName': 'Nixon', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Robinson', 'Affiliation': 'Center for Pain Research and Behavioral Health, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Boissoneault', 'Affiliation': 'Center for Pain Research and Behavioral Health, University of Florida, Gainesville, Florida, USA.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14381']
3191,32474130,Randomized controlled trial protocol for project BRIDGE: A telephone-administered motivational interviewing intervention targeting risky sexual behavior in older people living with HIV.,"PURPOSE


By 2020, 70% of people living with HIV in the United States will be greater than 50 years of age. As many as 37% of sexually active older people living with HIV (OPLWH) engage in HIV transmission sexual behaviors. In spite of repeated calls for secondary prevention interventions to reduce condomless sex in OPLWH, no age-appropriate, evidence-based secondary prevention interventions exist for this group. Furthermore, many OPLWH face barriers to engaging in face-to-face secondary prevention services because of HIV- and age-related stigma, comorbid mental and physical health conditions that complicate travel, or geographic isolation. High rates of depression in OPLWH may further complicate engagement in interventions intended to reduce HIV transmissions. Telephone-administered motivational interviewing may be a feasible and efficacious intervention for this population.
METHODS


This randomized controlled trial will test the efficacy of a 5-session telephone-administered motivational interviewing plus behavioral skills training (teleMI+BST) intervention versus a 5-session telephone-administered coping effectiveness training (teleCET) control intervention to reduce condomless sex in OPLWH. A diverse sample of 336 OPLWH will be recruited across the U.S. The primary analysis will test the efficacy of teleMI+BST to reduce occasions of non-condom protected anal and vaginal intercourse with HIV serodiscordant sex partners. Secondary analyses will examine the efficacy of teleMI+BST to reduce depressive symptoms in mildly depressed OPLWH.
CONCLUSION


This is the first large-scale RCT intended to reduce HIV sexual transmission risk behavior in OPLWH and will add to the literature on secondary prevention telehealth interventions for people living with HIV. ClinicalTrials.gov Identifier: NCT03004170. This trial has been conducted by the approval of the Institutional Review Board. Participants provided verbal consent to participate in this trial.",2020,The primary analysis will test the efficacy of teleMI+BST to reduce occasions of non-condom protected anal and vaginal intercourse with HIV serodiscordant sex partners.,"['older people living with HIV', 'people living with HIV', 'A diverse sample of 336 OPLWH will be recruited across the U.S']","['teleMI+BST', 'Telephone-administered motivational interviewing', '5-session telephone-administered motivational interviewing plus behavioral skills training (teleMI+BST) intervention versus a 5-session telephone-administered coping effectiveness training (teleCET) control intervention', 'telephone-administered motivational interviewing intervention']",['depressive symptoms'],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",336.0,0.216379,The primary analysis will test the efficacy of teleMI+BST to reduce occasions of non-condom protected anal and vaginal intercourse with HIV serodiscordant sex partners.,"[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Kahler', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA.'}, {'ForeName': 'Timothy G', 'Initials': 'TG', 'LastName': 'Heckman', 'Affiliation': 'College of Public Health, University of Georgia, 100 Foster Road, Athens, GA 30606, USA.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'College of Public Health, University of Georgia, 100 Foster Road, Athens, GA 30606, USA.'}, {'ForeName': 'Marilyn S', 'Initials': 'MS', 'LastName': 'Huckans', 'Affiliation': 'Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Sarah W', 'Initials': 'SW', 'LastName': 'Feldstein Ewing', 'Affiliation': 'Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Parsons', 'Affiliation': 'Mindful Designs, 791 Salem Street, Teaneck, NJ 07666, USA.'}, {'ForeName': 'Alissa', 'Initials': 'A', 'LastName': 'Phelps', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA; Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sutton', 'Affiliation': 'College of Public Health, University of Georgia, 100 Foster Road, Athens, GA 30606, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Holloway', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA; Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Travis I', 'Initials': 'TI', 'LastName': 'Lovejoy', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA; Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA. Electronic address: lovejoy@ohsu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106047']
3192,32474979,Isometric exercises do not provide immediate pain relief in Achilles tendinopathy: A quasi-randomized clinical trial.,"BACKGROUND


Isometric exercises may provide an immediate analgesic effect in patients with lower-limb tendinopathy and have been proposed as initial treatment and for immediate pain relief. Current evidence is conflicting, and previous studies were small.
OBJECTIVE


To study whether isometric exercises result in an immediate analgesic effect in patients with chronic midportion Achilles tendinopathy.
METHODS


Patients with clinically diagnosed chronic midportion Achilles tendinopathy were quasi-randomized to one of four arms: isometric calf-muscle exercises (tiptoes), isometric calf-muscle exercises (dorsiflexed ankle position), isotonic calf-muscle exercises, or rest. The primary outcome was pain measured on a visual analogue scale (VAS) score (0-100) during a functional task (10 unilateral hops) both before and after the intervention. Between-group differences were analyzed using a generalized estimation equations model.
RESULTS


We included 91 patients. There was no significant reduction in pain on the 10 hop test after performing any of the four interventions: isometric (tiptoes) group 0.2, 95%CI -11.2 to 11.5; isometric (dorsiflexed) group -1.9, 95%CI -13.6 to 9.7; isotonic group 1.4, 95%CI -8.3 to 11.1; and rest group 7.2, 95%CI -2.4 to 16.7. There were also no between-group differences after the interventions.
CONCLUSION


The isometric exercises investigated in this study did not result in immediate analgesic benefit in patients with chronic midportion Achilles tendinopathy. We do not recommend isometric exercises if the aim is providing immediate pain relief. Future research should focus on the use of isometric or isotonic exercise therapy as initial treatment as all exercise protocols used in this study were well-tolerated.",2020,"There was no significant reduction in pain on the 10 hop test after performing any of the four interventions: isometric (tiptoes) group 0.2, 95%CI -11.2 to 11.5; isometric (dorsiflexed) group -1.9, 95%CI -13.6 to 9.7; isotonic group 1.4, 95%CI -8.3 to 11.1; and rest group 7.2, 95%CI -2.4 to 16.7.","['patients with chronic midportion Achilles tendinopathy', '91 patients', 'Achilles', 'tendinopathy', 'Patients with clinically diagnosed chronic midportion Achilles tendinopathy', 'patients with lower-limb tendinopathy']","['Isometric exercises', 'isotonic exercise therapy', 'isometric calf-muscle exercises (tiptoes), isometric calf-muscle exercises (dorsiflexed ankle position), isotonic calf-muscle exercises, or rest', 'isometric exercises']","['pain measured on a visual analogue scale (VAS)-score (0-100) during a functional task (10 unilateral hops', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]","[{'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0448482', 'cui_str': 'Posterior crural muscle structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0950959', 'cui_str': 'Dorsiflex'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}]",91.0,0.139609,"There was no significant reduction in pain on the 10 hop test after performing any of the four interventions: isometric (tiptoes) group 0.2, 95%CI -11.2 to 11.5; isometric (dorsiflexed) group -1.9, 95%CI -13.6 to 9.7; isotonic group 1.4, 95%CI -8.3 to 11.1; and rest group 7.2, 95%CI -2.4 to 16.7.","[{'ForeName': 'Arco C', 'Initials': 'AC', 'LastName': 'van der Vlist', 'Affiliation': 'Department of Orthopedic Surgery and Sports Medicine, Erasmus MC University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Peter L J', 'Initials': 'PLJ', 'LastName': 'van Veldhoven', 'Affiliation': 'Department of Sports Medicine, Haaglanden Medical Center, The Hague, the Netherlands.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'van Oosterom', 'Affiliation': 'Department of Sports Medicine, Haaglanden Medical Center, The Hague, the Netherlands.'}, {'ForeName': 'Jan A N', 'Initials': 'JAN', 'LastName': 'Verhaar', 'Affiliation': 'Department of Orthopedic Surgery and Sports Medicine, Erasmus MC University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Robert-Jan', 'Initials': 'RJ', 'LastName': 'de Vos', 'Affiliation': 'Department of Orthopedic Surgery and Sports Medicine, Erasmus MC University Medical Center, Rotterdam, the Netherlands.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13728']
3193,32482534,"""Decision for adjuvant treatment in stage II colon cancer based on circulating tumor DNA:The CIRCULATE-PRODIGE 70 trial"".","BACKGROUND


Adjuvant treatment for stage II colon cancer remains debated. Finding a tool to select patients at risk for disease recurrence may help the clinical decision. Circulating tumor DNA (ctDNA) has been reported recently as a potential predictive marker for disease recurrence. We thus aim to test its ability to better select stage II colon cancer patients for adjuvant therapy.
METHODS


This national, phase III trial (NCT00002019-000935-15) conducted in more than 100 centers in France, plans to screen around 2640 patients in order to randomize (2:1; minimization method) 198 ctDNA positive patients. Patients aged 18 to 75 years with ECOG performance status ≤1 with R0 surgical resection of a pT3-T4aN0 colon or high rectum adenocarcinoma will be randomized within 63 days after curative-intent surgery, to adjuvant mFOLFOX6 (oxaliplatin 85 mg/m², leucovorin 400 mg/m², and 5-FU bolus 400 mg/m2 then 5FU Continuous infusion 2.4 g/m²) every two weeks for 12 cycles or observation. Patients will be followed for maximum 7 years. A gain of 17.5% in 3-yr disease free survival (DFS) is expected (42.5% in the experimental arm vs. 25% in the control arm; HR:0.62; α, 5% [two-sided log-rank test]; 1-β, 80%). Secondary endpoints include 2-yr DFS, overall survival, and toxicity. Recruitement began End of January 2020.",2020,"A gain of 17.5% in 3-yr disease free survival (DFS) is expected (42.5% in the experimental arm vs. 25% in the control arm; HR:0.62; α, 5% [two-sided log-rank test];","['Patients aged 18 to 75 years with ECOG performance status ≤1 with R0 surgical resection of a pT3-T4aN0 colon or high rectum adenocarcinoma', '000935-15) conducted in more than 100 centers in France, plans to screen around 2640 patients in order to randomize (2:1; minimization method) 198 ctDNA positive patients', 'stage II colon cancer', 'stage II colon cancer patients for adjuvant therapy', 'stage II colon cancer based on circulating tumor DNA']","['curative-intent surgery, to adjuvant mFOLFOX6 (oxaliplatin 85 mg/m², leucovorin 400 mg/m², and 5-FU bolus 400 mg/m2 then 5FU Continuous infusion 2.4 g/m²']","['survival (DFS', '2-yr DFS, overall survival, and toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332393', 'cui_str': 'pT3 category'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0034896', 'cui_str': 'Rectum structure'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3827014', 'cui_str': 'Cell-Free Tumor DNA'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0278479', 'cui_str': 'Carcinoma of colon, stage II'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C4517631', 'cui_str': '2.4'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",,0.265571,"A gain of 17.5% in 3-yr disease free survival (DFS) is expected (42.5% in the experimental arm vs. 25% in the control arm; HR:0.62; α, 5% [two-sided log-rank test];","[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Taïeb', 'Affiliation': 'Department of gastroenterology and GI Oncology, Georges-Pompidou European Hospital, AP-HP; Sorbonne Paris cité, Université de Paris, Paris, France. Electronic address: jtaieb75@gmail.com.'}, {'ForeName': 'Léonor', 'Initials': 'L', 'LastName': 'Benhaim', 'Affiliation': 'Département de chirurgie viscérale oncologique, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Laurent Puig', 'Affiliation': 'Pole biologie, Hospital European George Pompidou, Paris, Île-de-France, France.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Le Malicot', 'Affiliation': 'Fédération Francophone de Cancérologie Digestive; EPICAD INSERM LNC-UMR 1231, University of Burgundy and Franche Comté, Dijon, France.'}, {'ForeName': 'Jean François', 'Initials': 'JF', 'LastName': 'Emile', 'Affiliation': 'EA4340, Ambroise Pare Hospital, Beuvry, Hauts-de-France, France.'}, {'ForeName': 'Flore', 'Initials': 'F', 'LastName': 'Geillon', 'Affiliation': 'Fédération Francophone de Cancérologie Digestive; EPICAD INSERM LNC-UMR 1231, University of Burgundy and Franche Comté, Dijon, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tougeron', 'Affiliation': 'Gastroenterology Department and Medical Oncology Department, Poitiers University Hospital, Poitiers, France.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Manfredi', 'Affiliation': 'Fédération Francophone de Cancérologie Digestive; EPICAD INSERM LNC-UMR 1231, University of Burgundy and Franche Comté, Dijon, France; Centre de Recherche des Cordeliers, INSERM, CNRS, Sorbonne Université, USPC, Université de Paris, Equipe labellisée Ligue Nationale contre le cancer, Paris, France.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Chauvenet', 'Affiliation': 'Department of Gastroenterology, Groupement hospitalier Sud, Hospices civils de Lyon, Pierre Bénite, France.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Taly', 'Affiliation': 'Centre de Recherche des Cordeliers, INSERM, CNRS, Sorbonne Université, USPC, Université de Paris, Equipe labellisée Ligue Nationale contre le cancer, Paris, France.'}, {'ForeName': 'Côme', 'Initials': 'C', 'LastName': 'Lepage', 'Affiliation': 'Fédération Francophone de Cancérologie Digestive; EPICAD INSERM LNC-UMR 1231, University of Burgundy and Franche Comté, Dijon, France; Department of digestive oncology University hospital Dijon; University of Burgundy and Franche Comté, Dijon, France; Centre de Recherche des Cordeliers, INSERM, CNRS, Sorbonne Université, USPC, Université de Paris, Equipe labellisée Ligue Nationale contre le cancer, Paris, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'André', 'Affiliation': 'Sorbonne Université and Hôpital Saint Antoine, Paris, France.'}]",Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver,['10.1016/j.dld.2020.04.010']
3194,32483851,Effects of home-based pelvic floor muscle training on decreasing symptoms of stress urinary incontinence and improving the quality of life of urban adult Omani women: A randomized controlled single-blind study.,"AIM


This study aims to determine the effectiveness of home-based pelvic floor muscle training (PFMT) on decreasing the severity of symptoms and improving the quality of life (QOL) among Omani women with stress urinary incontinence (SUI).
METHODS


A randomized controlled single-blind trial was conducted in three primary health care centers in Muscat. Eligible women who were diagnosed with SUI (from a concurrent phase-I study which was a cross-sectional study to determine the prevalence of urinary incontinence in Oman) were invited to take part. The consenting subjects were randomly allocated to either an intervention group (unsupervised PFMT) or a control group (lecture with no PFMT). Baseline and 12-week assessment of both groups was carried out for the primary outcome using the validated Arabic version of the International Consultation on Incontinence Questionnaire (ICIQ)-short form and the secondary outcome by blinded measures of pelvic floor muscle (PFM) strength using the modified Oxford grading system (MOGS), endurance, and perineometer.
RESULTS


A total of 73 subjects were included in the study. They were randomly divided into two groups. Both groups were similar at the baseline in terms of sociodemographic characteristics, ICIQ score, and PFM strength. At the 12-weeks assessment, there was a significant difference in the ICIQ score (P < .001) between the intervention group and the control one. There was no statistical difference between the two groups in MOGS, endurance, or perineometer values.
CONCLUSIONS


The home-based PFMT is an effective treatment in reducing the severity of symptoms and improving the QOL in women with SUI.",2020,"At the 12-weeks assessment, there was a significant difference in the ICIQ score (P < .001) between the intervention group and the control one.","['women with SUI', 'Omani women with stress urinary incontinence (SUI', 'three primary health care centers in Muscat', 'A total of 73 subjects were included in the study', 'urban adult Omani women', 'urinary incontinence in Oman', 'Eligible women who were diagnosed with SUI (from a concurrent phase']","['home-based pelvic floor muscle training', 'intervention group (unsupervised PFMT', 'home-based pelvic floor muscle training (PFMT', 'control group (lecture with no PFMT']","['quality of life', 'validated Arabic version of the International Consultation on Incontinence Questionnaire (ICIQ)-short form and the secondary outcome by blinded measures of pelvic floor muscle (PFM) strength using the modified Oxford grading system (MOGS), endurance, and perineometer', 'ICIQ score', 'MOGS, endurance, or perineometer values', 'quality of life (QOL', 'sociodemographic characteristics, ICIQ score, and PFM strength']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205871', 'cui_str': 'Muscat'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0028971', 'cui_str': 'Oman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0574175', 'cui_str': 'Arabic language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C2711460', 'cui_str': 'International consultation on incontinence questionnaire'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1273712', 'cui_str': 'Grading system used'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0491718', 'cui_str': 'Perineometer'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",73.0,0.0513096,"At the 12-weeks assessment, there was a significant difference in the ICIQ score (P < .001) between the intervention group and the control one.","[{'ForeName': 'Zalikha I', 'Initials': 'ZI', 'LastName': 'Al Belushi', 'Affiliation': 'Department of Primary Care, North Batinah Governorate, Ministry of Health, Suhar, Oman.'}, {'ForeName': 'Maisa H', 'Initials': 'MH', 'LastName': 'Al Kiyumi', 'Affiliation': 'Department of Family Medicine and Public Health, Sultan Qaboos University Hospital, Muscat, Oman.'}, {'ForeName': 'Ahlaam A', 'Initials': 'AA', 'LastName': 'Al-Mazrui', 'Affiliation': 'Physiotherapy Department, Sultan Qaboos University Hospital, Muscat, Oman.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Jaju', 'Affiliation': 'Department of Family Medicine and Public Health, Sultan Qaboos University Hospital, Muscat, Oman.'}, {'ForeName': 'Abdul H', 'Initials': 'AH', 'LastName': 'Alrawahi', 'Affiliation': 'Department of Research and Studies, Oman Medical Specialty Board, Muscat, Oman.'}, {'ForeName': 'Abdulaziz M', 'Initials': 'AM', 'LastName': 'Al Mahrezi', 'Affiliation': 'Department of Family Medicine and Public Health, Sultan Qaboos University Hospital, Muscat, Oman.'}]",Neurourology and urodynamics,['10.1002/nau.24404']
3195,32480252,The Efficacy of Lidocaine in Disrupting Cocaine Cue-Induced Memory Reconsolidation.,"RATIONAL


Cue-induced craving memories, linked to drug-seeking behaviors, require key molecular processes for memory reconsolidation. Lidocaine, a sodium channel blocker, inhibits NMDA receptor activation and suppresses nitric oxide and ERK production. These processes are required for memory re-consolidation; inhibiting them may reduce cue-related craving memories in cocaine dependent subjects.
OBJECTIVES


To assess the efficacy of lidocaine in decreasing cue-induced cocaine craving and cocaine use.
METHODS


Treatment-seeking cocaine-dependent participants (n = 33, 25 men) were recruited. Personalized craving and relaxation scripts were developed. Participants were then randomly assigned in a double-blind design to either receive intravenous lidocaine immediately following a cocaine craving script (lidocaine/craving), saline following a craving script (saline/craving), or lidocaine following a relaxation script (lidocaine/relax). One week following the infusion, cue-induced craving was assessed in the same paradigm without an infusion. Cocaine use and craving were assessed for 4 weeks following infusion.
RESULTS


The administration of lidocaine during craving induction (lidocaine/craving) did not decrease cue-induced craving during craving reactivation one week later or craving and cocaine use over the 4-week follow-up period compared to the saline/craving group. There were no significant differences in craving and cocaine use between the lidocaine/relax and saline/craving groups.
CONCLUSION


Lidocaine administered following craving induction did not decrease subsequent cue-induced craving or cocaine use. Blocking the reconsolidation of craving-related memories with pharmacological agents remains an important area of investigation.",2020,The administration of lidocaine during craving induction (lidocaine/craving) did not decrease cue-induced craving during craving reactivation one week later or craving and cocaine use over the 4-week follow-up period compared to the saline/craving group.,"['Treatment-seeking cocaine-dependent participants (n = 33, 25 men']","['Lidocaine', 'lidocaine/craving', 'lidocaine', 'intravenous lidocaine', 'cocaine craving script (lidocaine/craving), saline following a craving script (saline/craving), or lidocaine following a relaxation script (lidocaine/relax', 'Cocaine']",['craving and cocaine'],"[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}]",,0.054462,The administration of lidocaine during craving induction (lidocaine/craving) did not decrease cue-induced craving during craving reactivation one week later or craving and cocaine use over the 4-week follow-up period compared to the saline/craving group.,"[{'ForeName': 'Josh E', 'Initials': 'JE', 'LastName': 'Becker', 'Affiliation': 'Department of Psychiatry, UT Southwestern Medical Center, Dallas, TX USA; School of Behavior and Brain Sciences, UT Dallas, Dallas, TX USA.'}, {'ForeName': 'Julianne L', 'Initials': 'JL', 'LastName': 'Price', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, FL USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Leonard', 'Affiliation': 'David Leonard Statistical Consulting, Wichita Falls, TX USA.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Suris', 'Affiliation': 'Department of Psychiatry, UT Southwestern Medical Center, Dallas, TX USA; VA North Texas Health Care System, Dallas, TX USA.'}, {'ForeName': 'Enas', 'Initials': 'E', 'LastName': 'Kandil', 'Affiliation': 'Department of Psychiatry, University of Colorado School of Medicine, Aurora, CO USA; Department of Anesthesiology & Pain Management, UT Southwestern Medical Center, Dallas, TX USA; School of Behavior and Brain Sciences, UT Dallas, Dallas, TX USA.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Shaw', 'Affiliation': 'Department of Psychiatry, UT Southwestern Medical Center, Dallas, TX USA; VA North Texas Health Care System, Dallas, TX USA.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Kroener', 'Affiliation': 'School of Behavior and Brain Sciences, UT Dallas, Dallas, TX USA.'}, {'ForeName': 'E Sherwood', 'Initials': 'ES', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, UT Southwestern Medical Center, Dallas, TX USA.'}, {'ForeName': 'Bryon', 'Initials': 'B', 'LastName': 'Adinoff', 'Affiliation': 'Department of Psychiatry, University of Colorado School of Medicine, Aurora, CO USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108062']
3196,32480307,Prolonged-release melatonin in Parkinson's disease patients with a poor sleep quality: A randomized trial.,"BACKGROUND


The present study was a randomized, double-blind, placebo-controlled, multi-center trial to evaluate the efficacy and safety of prolonged-release melatonin (PRM) in Parkinson's disease (PD) patients with poor sleep quality.
METHODS


PD patients with a global Pittsburgh Sleep Quality Index (PSQI) score > 5 were included. Patients were assessed using the PSQI, a rapid eye movement sleep behavior disorder screening questionnaire, the Epworth Sleepiness Scale, Non-Motor Symptoms Scale (NMSS), Parkinson's Disease Quality of Life-39 (PDQ-39), and Unified Parkinson's Disease Rating Scale (UPDRS)-III at the beginning of the study and after 4 weeks of treatment with 2 mg of PRM. Partial correlation analysis was performed to investigate the relationship between PSQI score and the other scales.
RESULTS


Thirty-four PD patients with poor sleep quality were enrolled and divided into 2 groups based on medication; PRM (n = 16) and placebo (n = 18). Regarding efficacy, PSQI was significantly improved in the PRM group compared to the control group. Improvement in the NMSS and PDQ-39 summary index were observed in the PRM but not in the placebo group; UPDRS-III score was not significantly changed in either group. PSQI improvement correlated with improvement in NMSS score and PDQ-39 summary index. Regarding safety, all enrolled subjects did not complain of side effects due to PRM.
CONCLUSION


PRM is an effective and safe treatment option for subjective sleep quality in PD patients and beneficial effects on sleep quality are associated with improved non-motor symptoms and quality of life in PD patients.",2020,Improvement in the NMSS and PDQ-39 summary index were observed in the PRM but not in the placebo group; UPDRS-III score was not significantly changed in either group.,"['PD patients with a global Pittsburgh Sleep Quality Index (PSQI) score', 'Thirty-four PD patients with poor sleep quality', ""Parkinson's disease (PD) patients with poor sleep quality"", '\xa05 were included', ""Parkinson's disease patients with a poor sleep quality""]","['Prolonged-release melatonin', 'prolonged-release melatonin (PRM', 'PRM', 'placebo']","['subjective sleep quality', ""PSQI, a rapid eye movement sleep behavior disorder screening questionnaire, the Epworth Sleepiness Scale, Non-Motor Symptoms Scale (NMSS), Parkinson's Disease Quality of Life-39 (PDQ-39), and Unified Parkinson's Disease Rating Scale"", 'efficacy, PSQI', 'NMSS and PDQ-39 summary index', 'efficacy and safety', 'NMSS score and PDQ-39 summary index', 'UPDRS-III score']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0751772', 'cui_str': 'REM sleep behavior disorder'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439070', 'cui_str': 'III'}]",,0.0488383,Improvement in the NMSS and PDQ-39 summary index were observed in the PRM but not in the placebo group; UPDRS-III score was not significantly changed in either group.,"[{'ForeName': 'Jong Hyeon', 'Initials': 'JH', 'LastName': 'Ahn', 'Affiliation': 'Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; Neuroscience Center, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Minkyeong', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; Neuroscience Center, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Suyeon', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Biostatistics, Soonchunhyang University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Wooyoung', 'Initials': 'W', 'LastName': 'Jang', 'Affiliation': 'Department of Neurology, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, Republic of Korea.'}, {'ForeName': 'Jinse', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Haeundae Paik Hospital, Inje University, Busan, Republic of Korea.'}, {'ForeName': 'Eungseok', 'Initials': 'E', 'LastName': 'Oh', 'Affiliation': 'Department of Neurology, Chungnam National University Hospital, College of Medicine, Daejun, Republic of Korea.'}, {'ForeName': 'Jin Whan', 'Initials': 'JW', 'LastName': 'Cho', 'Affiliation': 'Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; Neuroscience Center, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Ji Sun', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; Neuroscience Center, Samsung Medical Center, Seoul, Republic of Korea. Electronic address: sunnyfor@hanmail.net.'}, {'ForeName': 'Jinyoung', 'Initials': 'J', 'LastName': 'Youn', 'Affiliation': 'Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; Neuroscience Center, Samsung Medical Center, Seoul, Republic of Korea. Electronic address: genian@skku.edu.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.03.029']
3197,32480319,Effectiveness of an app-based cognitive behavioral therapy program for postpartum depression in primary care: A randomized controlled trial.,"OBJECTIVE


The objective of this study was to examine the effect of mobile phone applications (App) based cognitive behavioral therapy (CBT) on postpartum depression.
METHOD


A non-blinded parallel-group randomized controlled trial was conducted. The study population consisted of women attended to three health care centers in Kerman, Iran. Participants were recruited between September and November 2018, and randomized 1:1 to either the intervention group (mobile application access) or control group (no mobile application access). All participants completed the Edinburgh Postnatal Depression Scale (EPDS) at the baseline and 2 months after baseline. Data were analyzed using inferential statistics including chi-square, independent sample t-test, paired t-test and linear regression.
RESULTS


A total of 75 women with an average age of 27 years participated in this study. Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001). However, in the intervention group, the average EPDS score after intervention was 8.18 and in the control group was 15.05, which was statistically significant (p < 0.001).
CONCLUSION


These findings provide proof that providing a CBT program using a mobile application can lead to clinically important improvements in outcomes for mothers who suffer from postpartum depression.",2020,"Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001).","['Participants were recruited between September and November 2018', 'postpartum depression in primary care', 'women attended to three health care centers in Kerman, Iran', 'mothers who suffer from postpartum depression', '75 women with an average age of 27 years participated in this study']","['intervention group (mobile application access) or control group (no mobile application access', 'app-based cognitive behavioral therapy program', 'mobile phone applications (App) based cognitive behavioral therapy (CBT']","['Edinburgh Postnatal Depression Scale (EPDS', 'average EPDS score', 'EPDS score']","[{'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C3472185', 'cui_str': 'Edinburgh postnatal depression scale score'}]",75.0,0.174326,"Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001).","[{'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Jannati', 'Affiliation': 'Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Mazhari', 'Affiliation': 'Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Ahmadian', 'Affiliation': 'Medical Informatics Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran. Electronic address: ahmadianle@yahoo.com.'}, {'ForeName': 'Moghaddameh', 'Initials': 'M', 'LastName': 'Mirzaee', 'Affiliation': 'Epidemiology and Biostatistics, Kerman University of Medical Sciences, Kerman, Iran.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104145']
3198,32482455,Does exercising before or after a meal affect energy balance in adolescents with obesity?,"BACKGROUND AND AIM


Exercise timing has been suggested to affect appetite and energy intake (EI). The aim of this study was to examine the impact of exercising immediately before or after a meal on EI, appetite sensations and food reward (FR) in adolescents with obesity.
METHODS AND RESULTS


Seventeen adolescents with obesity completed 3 experimental sessions (randomized controlled trial): rest + lunch (CON); exercise + lunch (EX-MEAL); lunch + exercise (MEAL-EX). The exercise consisted of cycling 30 min at 65%V̇O 2peak . Outcomes included ad libitum EI (weighed lunch and dinner), FR (Leeds Food Preference Questionnaire at pre- and post-combination of exercise/rest and lunch, and pre-dinner) and appetite sensations (visual analogue scales). EI was not different between conditions. Compared with CON, relative EI at lunch was lower in EX-MEAL and MEAL-EX (p ≤ 0.05) and daily only in MEAL-EX (p < 0.01). Postprandial fullness was higher in EX-MEAL compared to CON. Compared with CON, both EX-MEAL and MEAL-EX attenuated the increase in wanting for sweet food and reduced explicit liking for fat.
CONCLUSIONS


These preliminary results suggest that exercising immediately before or after a meal produce few differences in appetite and have small beneficial effects on overall energy balance in adolescents with obesity, as well as on FR.
CLINICAL TRIALS


NCT03967782.",2020,"Compared with CON, relative EI at lunch was lower in EX-MEAL and MEAL-EX (p ≤ 0.05) and daily only in MEAL-EX (p < 0.01).","['adolescents with obesity', 'Seventeen adolescents with obesity completed 3 experimental sessions (randomized controlled trial']","['rest\xa0+\xa0lunch (CON); exercise\xa0+\xa0lunch (EX-MEAL); lunch\xa0+\xa0exercise (MEAL-EX', 'CON, both EX-MEAL and MEAL-EX']","['Postprandial fullness', 'EI, appetite sensations and food reward (FR', 'wanting for sweet food and reduced explicit liking', 'overall energy balance', 'ad libitum EI (weighed lunch and dinner), FR (Leeds Food Preference Questionnaire at pre- and post-combination of exercise/rest and lunch, and pre-dinner) and appetite sensations (visual analogue scales', 'appetite and energy intake (EI']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0453865', 'cui_str': 'Sweet food'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C4048877', 'cui_str': 'Supper'}, {'cui': 'C0016483', 'cui_str': 'Food Preferences'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",17.0,0.0334859,"Compared with CON, relative EI at lunch was lower in EX-MEAL and MEAL-EX (p ≤ 0.05) and daily only in MEAL-EX (p < 0.01).","[{'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Fillon', 'Affiliation': 'Université Clermont Auvergne, AME2P, F-63000, Clermont-Ferrand, France; UGECAM Obesity Hospital, Clermont-Ferrand, France. Electronic address: fillonalicia@gmail.com.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Beaulieu', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Miguet', 'Affiliation': 'Université Clermont Auvergne, AME2P, F-63000, Clermont-Ferrand, France.'}, {'ForeName': 'Mélina', 'Initials': 'M', 'LastName': 'Bailly', 'Affiliation': 'Université Clermont Auvergne, AME2P, F-63000, Clermont-Ferrand, France.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Finlayson', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Julian', 'Affiliation': 'CHU, Clermont-Ferrand, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Masurier', 'Affiliation': 'UGECAM Obesity Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Marie-Eve', 'Initials': 'ME', 'LastName': 'Mathieu', 'Affiliation': 'Department of Kinesiology, University of Montreal, 2100 Edouard-Montpetit, Montreal, H3C 3J7, Canada; Sainte-Justine UHC Research Center, 5757 Decelles, Montreal, H3T 1C5, Canada.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'CHU, Biostatistics unit, Clermont-Ferrand, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Duclos', 'Affiliation': 'Université Clermont Auvergne, AME2P, F-63000, Clermont-Ferrand, France; CHU, Clermont-Ferrand, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Boirie', 'Affiliation': 'Université Clermont Auvergne, AME2P, F-63000, Clermont-Ferrand, France; CHU, Clermont-Ferrand, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Thivel', 'Affiliation': 'Université Clermont Auvergne, AME2P, F-63000, Clermont-Ferrand, France; School of Psychology, University of Leeds, Leeds, UK.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.04.015']
3199,32488909,Immune phenotype of tumor microenvironment predicts response to bevacizumab in neoadjuvant treatment of ER-positive breast cancer.,"Antiangiogenic drugs are potentially a useful supplement to neoadjuvant chemotherapy for a subgroup of patients with human epidermal growth factor receptor 2 (HER2) negative breast cancer, but reliable biomarkers for improved response are lacking. Here, we report on a randomized phase II clinical trial to study the added effect of bevacizumab in neoadjuvant chemotherapy with FEC100 (5-fluorouracil, epirubicin and cyclophosphamide) and taxanes (n = 132 patients). Gene expression from the tumors was obtained before neoadjuvant treatment, and treatment response was evaluated by residual cancer burden (RCB) at time of surgery. Bevacizumab increased the proportion of complete responders (RCB class 0) from 5% to 20% among patients with estrogen receptor (ER) positive tumors (P = .02). Treatment with bevacizumab was associated with improved 8-year disease-free survival (P = .03) among the good responders (RCB class 0 or I). Patients treated with paclitaxel (n = 45) responded better than those treated with docetaxel (n = 21; P = .03). Improved treatment response was associated with higher proliferation rate and an immune phenotype characterized by high presence of classically activated M1 macrophages, activated NK cells and memory activated CD4 T cells. Treatment with bevacizumab increased the number of adverse events, including hemorrhage, hypertension, infection and febrile neutropenia, but despite this, the ECOG status was not affected.",2020,"Improved treatment response was associated with higher proliferation rate and an immune phenotype characterized by high presence of classically activated M1 macrophages, activated NK cells and memory activated CD4 T-cells.","['n =\u2009132 patients', 'ER positive breast cancer']","['docetaxel', 'paclitaxel', 'Bevacizumab', 'FEC100 (5-fluorouracil, epirubicin and cyclophosphamide) and taxanes', 'bevacizumab']","['number of adverse events, including hemorrhage, hypertension, infection and febrile neutropenia', 'proportion of complete responders (RCB class 0', 'eight year disease free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2938924', 'cui_str': 'Oestrogen receptor positive breast cancer'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0215136', 'cui_str': 'taxane'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2919268', 'cui_str': 'Residual cancer burden class'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",132.0,0.0215363,"Improved treatment response was associated with higher proliferation rate and an immune phenotype characterized by high presence of classically activated M1 macrophages, activated NK cells and memory activated CD4 T-cells.","[{'ForeName': 'Hedda', 'Initials': 'H', 'LastName': 'von der Lippe Gythfeldt', 'Affiliation': 'Department of Cancer Genetics, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Tonje', 'Initials': 'T', 'LastName': 'Lien', 'Affiliation': 'Department of Cancer Genetics, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Tekpli', 'Affiliation': 'Department of Cancer Genetics, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Laxmi', 'Initials': 'L', 'LastName': 'Silwal-Pandit', 'Affiliation': 'Department of Cancer Genetics, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Borgen', 'Affiliation': 'Department of Pathology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Øystein', 'Initials': 'Ø', 'LastName': 'Garred', 'Affiliation': 'Department of Pathology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Skjerven', 'Affiliation': 'Department of Breast and Endocrine Surgery, Drammen Hospital, Vestre Viken Hospital Trust, Drammen, Norway.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Schlichting', 'Affiliation': 'Department of Breast and Endocrine Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Steinar', 'Initials': 'S', 'LastName': 'Lundgren', 'Affiliation': 'Department of Oncology, St. Olavs University Hospital, Trondheim, Norway.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Wist', 'Affiliation': 'Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Naume', 'Affiliation': 'Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Vessela', 'Initials': 'V', 'LastName': 'Kristensen', 'Affiliation': 'Department of Cancer Genetics, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Anne-Lise', 'Initials': 'AL', 'LastName': 'Børresen-Dale', 'Affiliation': 'Department of Cancer Genetics, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ole Christian', 'Initials': 'OC', 'LastName': 'Lingjaerde', 'Affiliation': 'Department of Cancer Genetics, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Olav', 'Initials': 'O', 'LastName': 'Engebraaten', 'Affiliation': 'Department of Oncology, Oslo University Hospital, Oslo, Norway.'}]",International journal of cancer,['10.1002/ijc.33108']
3200,32490686,Pembrolizumab given concomitantly with chemoradiation and as maintenance therapy for locally advanced head and neck squamous cell carcinoma: KEYNOTE-412.,"Current treatment guidelines for patients with locally advanced head and neck squamous cell carcinoma (HNSCC) recommend multimodal treatment, including chemoradiation therapy (CRT) or surgery followed by radiation, with or without chemotherapy. The immune checkpoint inhibitor pembrolizumab has previously demonstrated antitumor activity in recurrent and/or metastatic HNSCC in large Phase III trials. For patients with locally advanced disease, Phase Ib data on the use of pembrolizumab in combination with chemoradiation have shown the approach to be safe and feasible. We describe here the design and rationale for KEYNOTE-412, a randomized, double-blind, Phase III trial investigating pembrolizumab or placebo administered concurrently with CRT and as maintenance treatment in patients with locally advanced HNSCC. Clinical Trial Registration: NCT03040999 (ClinicalTrials.gov).",2020,The immune checkpoint inhibitor pembrolizumab has previously demonstrated antitumor activity in recurrent and/or metastatic HNSCC in large Phase III trials.,"['patients with locally advanced HNSCC', 'patients with locally advanced disease', 'patients with locally advanced head and neck squamous cell carcinoma (HNSCC', 'locally advanced head and neck squamous cell carcinoma']","['chemoradiation therapy (CRT) or surgery followed by radiation, with or without chemotherapy', 'CRT', 'pembrolizumab', 'Pembrolizumab', 'pembrolizumab or placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.158035,The immune checkpoint inhibitor pembrolizumab has previously demonstrated antitumor activity in recurrent and/or metastatic HNSCC in large Phase III trials.,"[{'ForeName': 'Jean-Pascal', 'Initials': 'JP', 'LastName': 'Machiels', 'Affiliation': 'Department of Medical Oncology, Institut Roi Albert II, Cliniques Universitaires Saint-Luc & Institut de Recherche Clinique et Expérimentale, Université Catholique de Louvain (UCLouvain), Avenue Hippocrate 10, Brussels, Belgium.'}, {'ForeName': 'Yungan', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Department of Radiation Oncology, Gustave Roussy Cancer Campus, 114 Rue Edouard Vaillant, 94800, Villejuif, France.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Burtness', 'Affiliation': 'Department of Medicine, Yale University School of Medicine & Yale Cancer Center, 333 Cedar Street, New Haven, CT 06510, USA.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Tahara', 'Affiliation': 'Department of Head & Neck Medical Oncology, National Cancer Center Hospital East, 6-Chome-5-1 Kashiwanoha, Kashiwa, Chiba, 27-8577, Japan.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Licitra', 'Affiliation': 'Department of Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori and University of Milan, Via Giacomo Venezian 1, 20133, Milan, Italy.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Rischin', 'Affiliation': 'Department of Medical Oncology, Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne, VIC, 3000, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Waldron', 'Affiliation': 'Department of Radiation Oncology University of Toronto, Princess Margaret Cancer Centre, 610 University Avenue, Toronto, ON, M5G 2M9, Canada.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Simon', 'Affiliation': 'Department of Otorhinolaryngology, University Hospital CHUV, Rue du Bugnon 21, 1011, Lausanne, Switzerland.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Gregoire', 'Affiliation': 'Department of Radiation Oncology, Centre Leon Berard, 28 Prom. Lea et Napoleon Bullukian, 69008, Lyon, France.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Harrington', 'Affiliation': 'Division of Radiotherapy & Imaging, The Institute of Cancer Research, London, SW3 6JB, UK.'}, {'ForeName': 'Gustavo Vasconcelos', 'Initials': 'GV', 'LastName': 'Alves', 'Affiliation': 'Centro Integardo de Pesquisa em Oncologia, Hospital Nossa Senhora da Conceição, Avenida Francisco Trein, 596 - Cristo Redentor Porto Alegre - RS, 91350-200, Brazil.'}, {'ForeName': 'Iane Pinto', 'Initials': 'IP', 'LastName': 'Figueiredo Lima', 'Affiliation': 'Crio Centro Regional Integrado de Oncologia, R. Francisco Calaca, 1300 - Alvaro Weyne, Fortaleza - CE, 60335-480, Brazil.'}, {'ForeName': 'Yoann', 'Initials': 'Y', 'LastName': 'Pointreau', 'Affiliation': 'Department of Radiation Oncology, Institut Inter-Regional de Cancerologie-Centre Jean Bernard/Clinique Victor Hugo, 72000, Le Mans, France.'}, {'ForeName': 'Brett G', 'Initials': 'BG', 'LastName': 'M Hughes', 'Affiliation': ""Cancer Care Services, Royal Brisbane & Women's Hospital, Butterfield Street, Herston QLD 4029, Australia & School of Medicine, University of Queensland, 20 Weightman Street, Herston, QLD, 4006, Australia.""}, {'ForeName': 'Sercan', 'Initials': 'S', 'LastName': 'Aksoy', 'Affiliation': 'Hacettepe University, Cancer Institute, Department of Medical Oncology, 06100, Ankara, Turkey.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Hetnal', 'Affiliation': 'Faculty of Medicine & Health Sciences, Andrzej Frycz Modrzewski Krakow University, Amethyst Radiotherapy Centre, Rydygier Hospital, Krakow, Poland, Złotej Jesieni 1, Krakow, Poland.'}, {'ForeName': 'Joy Y', 'Initials': 'JY', 'LastName': 'Ge', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Brown', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA.'}, {'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Bidadi', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA.'}, {'ForeName': 'Lillian L', 'Initials': 'LL', 'LastName': 'Siu', 'Affiliation': 'Division of Medical Oncology & Hematology, Princess Margaret Cancer Centre, University Health Network, 610 University Avenue, Toronto, ON, M5G 2M9, Canada.'}]","Future oncology (London, England)",['10.2217/fon-2020-0184']
3201,32485550,Effects of couple conflict on alcohol craving: Does intimate partner violence play a role?,"OBJECTIVE


Social stress in the form of maladaptive relationship conflict is a common precipitant to alcohol misuse and problems. Research has also established a clear causal association between alcohol misuse and relationship conflict in the form of intimate partner violence (IPV). Despite the robust literature linking relationship conflict and problematic drinking using survey methodology, no laboratory studies have examined the proximal association between relationship conflict and alcohol craving among couples, or the influence of IPV perpetration and victimization on this association.
METHOD


As part of a larger randomized controlled trial, 30 different-sex community couples with substance misuse completed a laboratory conflict resolution task. Participants reported subjective alcohol craving on a Likert-type scale immediately, before, and after the task. Conflict behaviors were coded by trained observers. Analyses were conducted using a multilevel modeling framework to account for the dyadic nature of the data.
RESULTS


Findings indicate that psychological and physical IPV perpetration and victimization strengthened the associations between negative and positive conflict behaviors and alcohol craving among men only. Contrary to our hypotheses, no main or moderating effects of conflict behaviors, IPV perpetration, or IPV victimization were found for women.
CONCLUSIONS


Findings from this exploratory study suggest that in this sample, relationship conflict and IPV in one's current relationship played a more impactful role on acute alcohol craving among men compared to women. Future studies should examine the role of specific conflict behaviors on alcohol craving and relapse risk, and patterns of communication that might increase or reduce risk for exacerbated alcohol craving.",2020,"RESULTS


Findings indicate that psychological and physical IPV perpetration and victimization strengthened the associations between negative and positive conflict behaviors and alcohol craving among men only.",['30 different-sex community couples with substance misuse completed a laboratory conflict resolution task'],['couple conflict'],"['subjective alcohol craving', 'negative and positive conflict behaviors and alcohol craving', 'conflict behaviors, IPV perpetration, or IPV victimization', 'acute alcohol craving', 'alcohol craving', 'Conflict behaviors']","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0150526', 'cui_str': 'Conflict Resolution'}]","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]",,0.0159769,"RESULTS


Findings indicate that psychological and physical IPV perpetration and victimization strengthened the associations between negative and positive conflict behaviors and alcohol craving among men only.","[{'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, 67 President St, Charleston, SC 29425, United States; Ralph H. Johnson VA Medical Center, United States. Electronic address: hellmuth@musc.edu.'}, {'ForeName': 'Amber M', 'Initials': 'AM', 'LastName': 'Jarnecke', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, 67 President St, Charleston, SC 29425, United States.'}, {'ForeName': 'Ruschelle M', 'Initials': 'RM', 'LastName': 'Leone', 'Affiliation': 'Mark Chaffin Center for Healthy Development, School of Public Health, Georgia State University, P.O. Box 3995, Atlanta, GA 30302, United States; Department of Health Policy & Behavioral Sciences, School of Public Health, Georgia State University, P.O. Box 3995, Atlanta, GA 30302, United States.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Oesterle', 'Affiliation': 'Mark Chaffin Center for Healthy Development, School of Public Health, Georgia State University, P.O. Box 3995, Atlanta, GA 30302, United States; Department of Health Policy & Behavioral Sciences, School of Public Health, Georgia State University, P.O. Box 3995, Atlanta, GA 30302, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106474']
3202,32468855,Comparison between two fast threshold strategies: SPARK and SITA in normal subjects.,"BACKGROUND


Numerous fast threshold strategies have been developed in perimetry which use maximum likelihood approaches to estimate the threshold. A recent approach to threshold estimation has been developed estimating the threshold from a limited number of test points which further reduces examination time. This strategy, SPARK, has not been compared to the SITA strategy. The aim of this study was to compare SPARK with SITA in a normal cohort to evaluate within and between strategy agreement in threshold estimates.
METHODS


A total of 83 normal subjects each underwent two visual field examinations with SITA and SPARK on two separate occasions on a randomly selected eye. The eye examined and the order of strategy examined first was randomised but remained constant over the two perimetry visits.
RESULTS


Visual field examination with SPARK Precision was on average 33% faster than SITA Standard. A positive correlation between group mean sensitivities of SITA Standard and SPARK Precision (rho = 0.713, p < 0.001) was found. In total, 95% of stimulus locations were located within the 95% limits of agreement and linear regression on the differences in sensitivities showed no statistically significant proportional bias (t = 1.713, p = 0.09). Pointwise analysis showed SITA Standard had significantly larger variability for individual stimulus locations examined over two visits when compared to SPARK (t = 9.175, p < 0.001).
CONCLUSION


The clinical examination of SPARK yields a sensitivity profile similar to SITA but in a faster examination time. The lower threshold variability of SPARK may be as a result of data smoothing in the threshold estimation process.",2020,"Pointwise analysis showed SITA Standard had significantly larger variability for individual stimulus locations examined over two visits when compared to SPARK (t = 9.175, p < 0.001).
","['normal subjects', '83 normal subjects each underwent two visual field examinations with SITA and SPARK on two separate occasions on a randomly selected eye']",[],['mean sensitivities of SITA Standard and SPARK Precision'],"[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",83.0,0.0690914,"Pointwise analysis showed SITA Standard had significantly larger variability for individual stimulus locations examined over two visits when compared to SPARK (t = 9.175, p < 0.001).
","[{'ForeName': 'Foo', 'Initials': 'F', 'LastName': 'Say Kiang', 'Affiliation': 'SEGi University, Faculty of Optometry & Vision Sciences, Petaling Jaya, Malaysia.'}, {'ForeName': 'Cubbidge', 'Initials': 'C', 'LastName': 'Robert Peter', 'Affiliation': 'School of Life and Health Sciences, Aston University, Birmingham, UK.'}, {'ForeName': 'Heitmar', 'Initials': 'H', 'LastName': 'Rebekka', 'Affiliation': 'School of Life and Health Sciences, Aston University, Birmingham, UK.'}]",European journal of ophthalmology,['10.1177/1120672120926455']
3203,32463786,Comparative Effectiveness of 2 Diabetes Prevention Lifestyle Programs in the Workplace: The City and County of San Francisco Diabetes Prevention Trial.,"INTRODUCTION


Data on the comparative effectiveness of Diabetes Prevention Programs (DPPs) in the workplace are limited.
METHODS


Between September 2015 and July 2016, employees of the City and County of San Francisco who were at risk for type 2 diabetes (N = 158) were randomly assigned to one of 2 DPP-derived programs recognized by the Centers for Disease Control and Prevention: an in-person YMCA-DPP (n = 78) or an online virtual lifestyle management DPP (VLM-DPP) offered through Canary Health (n = 80). The primary outcome was change in body weight assessed at 6 and 12 months. Follow-up ended in August 2017.
RESULTS


Both the YMCA-DPP and VLM-DPP yielded a significant reduction in percentage body weight at 6 months. For the YMCA-DPP, mean percentage change at 6 months was -2.70% (95% confidence interval [CI], -3.91% to -1.48%) and at 12 months was -2.46% (95% CI, -4.24% to -0.68%). For the VLM-DPP, mean percentage change at 6 months was -2.41% (95% CI, -4.07% to -0.77%) and at 12 months was -1.59% (95% CI, -3.51% to 0.33%). The mean between-condition difference at 6 months was -0.25% (95% CI, -2.04% to 1.55%) and at 12 months was -0.84% (95% CI, -3.03% to 1.34%). No significant differences were observed between conditions. The YMCA-DPP had a slightly higher reduction in waist circumference than VLM-DDP at 6 months (mean between-condition difference -2.00 cm [95% CI, -4.24 to 0.25 cm]). Participant engagement, expressed as mean number of completed core program sessions, was significantly higher for the YMCA-DPP than the VLM-DPP. Participants of the YMCA-DPP completed an average of 10.2 sessions (95% CI, 9.0 to 11.4), and participants of the VLM-DPP completed an average of 5.9 sessions (95% CI, 4.7 to 7.1). The adjusted mean between-condition difference was 4.2 sessions (95% CI, 2.54 to 5.99).
CONCLUSION


Both the YMCA-DPP and VLM-DPP yielded weight loss at 6 months, which was maintained at 12 months in the YMCA-DPP. The workplace may be an effective setting to offer DPPs.",2020,The YMCA-DPP had a slightly higher reduction in waist circumference than VLM-DDP at 6 months,"['N = 158', 'Between September 2015 and July 2016, employees of the City and County of San Francisco who were at risk for type 2 diabetes']","['2 Diabetes Prevention Lifestyle Programs', 'Diabetes Prevention Programs (DPPs', 'DPP-derived programs recognized by the Centers for Disease Control and Prevention: an in-person YMCA-DPP (n = 78) or an online virtual lifestyle management DPP (VLM-DPP) offered through Canary Health']","['weight loss', 'change in body weight', 'waist circumference', 'percentage body weight']","[{'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0007670', 'cui_str': 'Centers for Disease Control and Prevention (U.S.)'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0006824', 'cui_str': 'Genus Serinus'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",158.0,0.0835716,The YMCA-DPP had a slightly higher reduction in waist circumference than VLM-DDP at 6 months,"[{'ForeName': 'Assiamira', 'Initials': 'A', 'LastName': 'Ferrara', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA 94612. Email: assiamira.ferrara@kp.org.'}, {'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'McDonald', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, California.'}, {'ForeName': 'Susan D', 'Initials': 'SD', 'LastName': 'Brown', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, California.'}, {'ForeName': 'Janet G', 'Initials': 'JG', 'LastName': 'Alexander', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, California.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Christian-Herman', 'Affiliation': 'Kaiser Foundation Health Plan, Oakland, California.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Fisher', 'Affiliation': 'San Francisco Health Service System, San Francisco, California.'}, {'ForeName': 'Charles P', 'Initials': 'CP', 'LastName': 'Quesenberry', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, California.'}]",Preventing chronic disease,['10.5888/pcd17.190396']
3204,32470147,Effect of non-sedation on post-traumatic stress and psychological health in survivors of critical illness-A substudy of the NONSEDA randomized trial.,"BACKGROUND


Critical illness can cause post-traumatic stress and impaired mental health. The NONSEDA trial was a Scandinavian multicenter RCT, assessing non-sedation versus sedation with a daily wake-up call during mechanical ventilation in critically ill adults. The aim of this substudy was to assess the effect of non-sedation on post-traumatic stress and mental health.
METHODS


This substudy is based on all participating patients from a single NONSEDA trial site (Kolding, Denmark). Patients were randomized to sedation or non-sedation within the first 24 hours of mechanical ventilation. Three months after ICU discharge survivors were examined by a neuropsychologist for post-traumatic stress, anxiety and depression, and filled out the SF-36 questionnaire regarding quality of life.
RESULTS


The two groups of survivors were similar with regard to baseline characteristics, length of admission and mechanical ventilation. Sedated patients received more propofol and midazolam. Doses of morphine and haloperidole were equal.
PRIMARY OUTCOME


the number of patients with post-traumatic stress disorder did not differ between groups (non-sedated: 2 patients vs sedated: 0, P = .23).
SECONDARY OUTCOMES


there were no differences between groups in Beck Anxiety Index (median, non-sedated: 0 vs sedated: 0, P = .62), Beck Depression Index (median, non-sedated: 7 vs sedated: 4, P = .24), SF-36 mental component score (mean, non-sedated: 46.7 vs sedated: 47.5, P = .73) or number of patients with symptoms of post-traumatic stress (8 in both groups, P = .89).
CONCLUSION


Levels of PTSD, anxiety and depression and quality of life regarding mental health were similar between the non-sedated and sedated group.",2020,"There were no differences between groups in either Beck Anxiety Index (median, non-sedated: 0 vs sedated: 0, p=0.62), Beck Depression Index (median, non-sedated: 7 vs sedated: 4, p=0.24), SF-36 mental component score (mean, non-sedated: 46.7 vs sedated: 47.5, p=0.73) or number of patients with symptoms of posttraumatic stress (8 in both groups, p=0.89).
","['survivors of critical illness', 'critically ill adults', 'participating patients from a single NONSEDA trial-site (Kolding, Denmark']","['propofol and midazolam', 'morphine', 'non-sedation', 'sedation or non-sedation']","['Beck Anxiety Index', 'number of patients with symptoms of posttraumatic stress', 'Beck Depression Index', 'number of patients with posttraumatic stress disorder', 'PTSD, anxiety and depression and quality of life regarding mental health', 'posttraumatic stress and psychological health', 'SF-36 mental component score']","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0854969,"There were no differences between groups in either Beck Anxiety Index (median, non-sedated: 0 vs sedated: 0, p=0.62), Beck Depression Index (median, non-sedated: 7 vs sedated: 4, p=0.24), SF-36 mental component score (mean, non-sedated: 46.7 vs sedated: 47.5, p=0.73) or number of patients with symptoms of posttraumatic stress (8 in both groups, p=0.89).
","[{'ForeName': 'Helene K', 'Initials': 'HK', 'LastName': 'Nedergaard', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Lillebaelt Hospital Kolding, University Hospital of Southern Denmark, Kolding, Denmark.'}, {'ForeName': 'Hanne I', 'Initials': 'HI', 'LastName': 'Jensen', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Lillebaelt Hospital Kolding, University Hospital of Southern Denmark, Kolding, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Stylsvig', 'Affiliation': 'Clinic of Neuropsychology, Odense, Denmark.'}, {'ForeName': 'Hanne T', 'Initials': 'HT', 'LastName': 'Olsen', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Strøm', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Palle', 'Initials': 'P', 'LastName': 'Toft', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Odense University Hospital, Odense, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13648']
3205,32473149,Linear Growth between Early and Late Childhood and Cognitive Outcomes at 6 to 9 Years of Age.,"OBJECTIVES


To assess the extent to which linear growth beyond the early years of life determines later cognitive development.
STUDY DESIGN


We revisited children from New Delhi, India who had participated in a randomized controlled trial six years before and assessed neurodevelopment using standardized and validated psychometric tools (Wechsler Intelligence Scale for Children 4 th  edition, WISC-IV INDIA ; Crichton Vocabulary Scales, CVS; and Neuropsychological test battery, NEPSY-II). The associations of change in height for age z scores (HAZ) between early (12-36 months) and late (6-9 years) childhood with cognitive outcomes at 6-9 years of age were explored using linear regression models, after adjustment for appropriate confounders.
RESULTS


Out of the 1,000 North Indian children that were enrolled in the original study, 791 consented to participate in this follow-up. HAZ in the first two years of life was significantly associated with both the WISC-CVS [standardized beta coefficient (ẞ) 0.15, 95% CI: 0.08, 0.23], and the NEPSY-II z-score [ẞ 0.09, 95% CI: 0.03, 0.18] at 6-9 years of age. There were no significant associations between change in HAZ scores between early and later childhood and WISC-CVS [ẞ -0.03, 95% CI: -0.11 to 0.04] or NEPSY-II z-scores [ẞ -0.04, 95% CI: -0.12 to 0.06].
CONCLUSION(S)


Linear growth between early and late childhood is not associated with later cognitive outcomes. Our findings support the current practice of investing public health efforts to accelerate linear growth in the first 2-3 years of life.",2020,"There were no significant associations between change in HAZ scores between early and later childhood and WISC-CVS [ẞ -0.03, 95% CI: -0.11 to 0.04] or NEPSY-II z-scores [ẞ -0.04, 95% CI: -0.12 to 0.06].
","['revisited children from New Delhi, India who had participated', '1,000 North Indian children that were enrolled in the original study, 791 consented to participate in this follow-up']",['HAZ'],"['psychometric tools (Wechsler Intelligence Scale for Children 4 th  edition, WISC-IV INDIA ; Crichton Vocabulary Scales, CVS; and Neuropsychological test battery, NEPSY-II', 'HAZ scores', 'Linear Growth between Early and Late Childhood and Cognitive Outcomes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0086541', 'cui_str': 'Dry form of cutaneous leishmaniasis'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",[],"[{'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0204457', 'cui_str': 'Wechsler intelligence scale for children'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0451093', 'cui_str': 'Crichton vocabulary scale'}, {'cui': 'C0008509', 'cui_str': 'Sampling of chorionic villus'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C2987126', 'cui_str': 'NEPSY'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0581295,"There were no significant associations between change in HAZ scores between early and later childhood and WISC-CVS [ẞ -0.03, 95% CI: -0.11 to 0.04] or NEPSY-II z-scores [ẞ -0.04, 95% CI: -0.12 to 0.06].
","[{'ForeName': 'Ravi Prakash', 'Initials': 'RP', 'LastName': 'Upadhyay', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, New Delhi; Centre for International Health, University of Bergen, Norway.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Hysing', 'Affiliation': 'Department of Psychosocial science, Faculty of Psychology, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Taneja', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, New Delhi. Electronic address: sunita.taneja@sas.org.in.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Kvestad', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare, West, NORCE Norwegian Research Centre, Bergen, Norway.'}, {'ForeName': 'Nita', 'Initials': 'N', 'LastName': 'Bhandari', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, New Delhi.'}, {'ForeName': 'Tor A', 'Initials': 'TA', 'LastName': 'Strand', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare, West, NORCE Norwegian Research Centre, Bergen, Norway; Department of Research, Innlandet Hospital Trust, Lillehammer, Norway.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.05.043']
3206,32473186,"The effects of GAMotion (a giant exercising board game) on physical capacity, motivation and quality of life among nursing home residents: A pilot interventional study.","BACKGROUND


In 2017, our team highlighted promising results of a giant exercising board game on physical activity level and a broader array of physical and psychological outcomes among nursing home residents. However, some improvements of this game were needed to make it more suitable for nursing homes and more challenging in terms of exercises. Therefore, we decided to develop a new version of a giant exercising board game: the GAMotion.
OBJECTIVES


The primary objective of this pilot study was to assess the impact of the GAMotion on physical capacity among nursing home residents. The secondary aims were to assess the impact of the GAMotion on motivation and quality of life in this population.
METHODS


A one-month pilot interventional study was performed in two comparable nursing homes. Eleven participants meeting the inclusion criteria took part in the intervention in one nursing home, whereas 10 participants were assigned to the control group in the other institution. The GAMotion required participants to perform strength, flexibility, balance and endurance activities. The assistance provided by an exercising specialist decreased gradually during the intervention in an autonomy-oriented approach based on the self-determination theory. Physical capacity (i.e. fall risk using Tinetti test; dynamic balance using Timed Up and Go test (TUG); physical abilities using SPPB test; grip strength using Jamar dynamometer; isometric lower limb muscle strength using MicroFET2 and quantitative evaluation of walking using Locometrix), motivation (i.e. using Behavioral Regulation in Exercise Questionnaire-2) and quality of life (i.e. using EQ-5D questionnaire) were assessed at baseline and at the end of the intervention. A two-way repeated-measure analysis of variance (ANOVA) was used to assess time*group (intervention vs. control group) effects. All the analyses were adjusted on age, which differed significantly between the 2 groups at baseline.
RESULTS


During the intervention period, the experimental group displayed a greater improvement in Tinetti score (p < 0.0001), TUG (p = 0.02), SPPB (p < 0.0001), knee extensor isometric strength (p = 0.04), grip strength (p = 0.02), symmetry of steps (p = 0.04), 3 domains of the EQ-5D (i.e. mobility, self-care, usual activities: p < 0.0001) and intrinsic motivation (p = 0.02) compared to the control group. No significant improvement was demonstrated on the other parameters.
CONCLUSION


These promising results should be interpreted with caution because of certain limitations (e.g. small sample size, no blind assessment). Further investigation is required to confirm and evaluate the long-term effectiveness of the GAMotion in nursing homes.",2020,"During the intervention period, the experimental group displayed a greater improvement in Tinetti score (p < 0.0001), TUG (p = 0.02), SPPB (p < 0.0001), knee extensor isometric strength (p = 0.04), grip strength (p = 0.02), symmetry of steps (p = 0.04), 3 domains of the EQ-5D (i.e. mobility, self-care, usual activities: p < 0.0001) and intrinsic motivation (p = 0.02) compared to the control group.","['nursing home residents', 'Eleven participants meeting the inclusion criteria took part in the intervention in one nursing home, whereas 10 participants were assigned to the control group in the other institution', 'two comparable nursing homes']","['GAMotion', 'GAMotion (a giant exercising board game']","['SPPB', 'TUG', 'intrinsic motivation', 'knee extensor isometric strength', 'motivation and quality of life', 'grip strength', 'physical capacity, motivation and quality of life', 'physical capacity', 'strength, flexibility, balance and endurance activities', 'quality of life (i.e. using EQ-5D questionnaire', 'Tinetti score', 'Physical capacity']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0017547', 'cui_str': 'Gigantism'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0392350', 'cui_str': 'Intrinsic motivation'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",2.0,0.028377,"During the intervention period, the experimental group displayed a greater improvement in Tinetti score (p < 0.0001), TUG (p = 0.02), SPPB (p < 0.0001), knee extensor isometric strength (p = 0.04), grip strength (p = 0.02), symmetry of steps (p = 0.04), 3 domains of the EQ-5D (i.e. mobility, self-care, usual activities: p < 0.0001) and intrinsic motivation (p = 0.02) compared to the control group.","[{'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Buckinx', 'Affiliation': 'WHO Collaborating Center for Public Health aspects of musculo-skeletal health and ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, Belgium. Electronic address: fanny.buckinx@uliege.be.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bruyère', 'Affiliation': 'WHO Collaborating Center for Public Health aspects of musculo-skeletal health and ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, Belgium; Department of Sport and Rehabilitation Sciences, Multidisciplinary Research Unit on Health and Society, University of Liège, Liège, Belgium.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Lengelé', 'Affiliation': 'WHO Collaborating Center for Public Health aspects of musculo-skeletal health and ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, Belgium.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Reginster', 'Affiliation': 'WHO Collaborating Center for Public Health aspects of musculo-skeletal health and ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, Belgium.'}, {'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Marchal', 'Affiliation': 'Department of Sport and Rehabilitation Sciences, Multidisciplinary Research Unit on Health and Society, University of Liège, Liège, Belgium.'}, {'ForeName': 'Paulin', 'Initials': 'P', 'LastName': 'Hurtrez', 'Affiliation': 'Department of Sport and Rehabilitation Sciences, Multidisciplinary Research Unit on Health and Society, University of Liège, Liège, Belgium.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Mouton', 'Affiliation': 'Department of Sport and Rehabilitation Sciences, Multidisciplinary Research Unit on Health and Society, University of Liège, Liège, Belgium.'}]",Experimental gerontology,['10.1016/j.exger.2020.110983']
3207,32473928,Short-term interval exercise suppresses acylated ghrelin and hunger during caloric restriction in women with obesity.,"Caloric restriction is suggested to increase hunger, in part, through complex interactions of hormones and behavior that contribute to challenges in long-term weight loss. Although intense exercise may attenuate appetite, no data exist testing the effects of interval exercise (INT) during a low-calorie diet (LCD) on appetite regulation. We hypothesized that LCD+INT would favorably influence satiety when compared with an energy-deficit matched LCD in women with obesity. Twenty-six women with obesity (47.3±2.4 yrs; 37.3 ± 1.2 kg/m 2 ) were randomized to either LCD (n = 13; mixed meals of ~1200 kcal/d) or LCD+INT (n = 13; 60 min/d of supervised interval exercise at 90% HRpeak for 3 min and 50% HRpeak for 3 min) for 2 weeks. An additional 350kcal (shake) was provided to LCD+INT individuals post-exercise to equate energy availability between groups. Total PYY, acylated ghrelin and des-ghrelin were measured at 0, 30 and 60 min of a 75g OGTT before and after the intervention. Visual analog scales were also administered at 0 and 120 min of the OGTT to assess appetite perception. Food logs were recorded prior to and during the intervention to ensure caloric intake compliance. Compared with pre-intervention conditions, both interventions decreased food intake (P = 0.001) and body fat (P < 0.01). There was no effect on fasting PYY, but both LCD and LCD+INT increased post-prandial PYY iAUC (P < 0.001) relative to pre-intervention. LCD+INT maintained fasting acylated ghrelin (P = 0.06) and suppressed post-prandial acylated ghrelin iAUC (P = 0.04) compared to LCD. Neither intervention impacted circulating des- ghrelin before or following the OGTT. Interestingly, LCD+INT attenuated fasting hunger and maintained fullness compared with LCD (P = 0.05 and P = 0.06, respectively). Taken together, interval exercise favors acylated ghrelin suppression and perception of hunger during a LCD in women with obesity.",2020,"Compared with pre-intervention conditions, both interventions decreased food intake (P=0.001) and body fat (P<0.01).","['women with obesity', 'Twenty-six women with obesity (47.3±2.4 yrs; 37.3±1.2 kg/m 2 ']","['interval exercise (INT', 'LCD+INT', 'Short-term interval exercise', 'LCD', 'supervised interval exercise at 90% HRpeak for 3 min and 50% HRpeak', 'interval exercise favors acylated ghrelin suppression and perception of hunger during a LCD']","['Total PYY, acylated ghrelin and des-ghrelin', 'appetite perception', 'food intake', 'Visual analog scales', 'fasting hunger and maintained fullness']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0450349', 'cui_str': '26'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0011702', 'cui_str': '4-(4-Amino-4-Carboxybutyl)-1-(5-Amino-5-Carboxypentyl)-3,5-bis(3-Amino-3-Carboxypropyl)pyridinium'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}]",26.0,0.0280904,"Compared with pre-intervention conditions, both interventions decreased food intake (P=0.001) and body fat (P<0.01).","[{'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Malin', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, United States; Division of Endocrinology & Metabolism, University of Virginia, Charlottesville, VA, United States; Robert M. Berne Cardiovascular Research Center, University of Virginia, Charlottesville, VA, United States. Electronic address: skm6n@virginia.edu.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Heiston', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, United States.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Gilbertson', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, United States.'}, {'ForeName': 'Natalie Z M', 'Initials': 'NZM', 'LastName': 'Eichner', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, United States.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.112978']
3208,32474918,"An open-label cluster-randomized controlled trial of chloroquine, hydroxychloroquine or only supportive care in patients admitted with moderate to severe COVID-19 (ARCHAIC)-Protocol publication.",,2020,"Based on unpublished anecdotal positive results in China, CQ is now implemented in China and the Netherlands in moderate to severe COVID-19.","['patients admitted with moderate to severe COVID-19 (ARCHAIC) - Protocol publication', 'COVID-19 in China']","['Chloroquine (CQ) and hydroxychloroquine (HCQ', 'chloroquine, hydroxychloroquine']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0034036', 'cui_str': 'Printed material'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]",[],,0.0514377,"Based on unpublished anecdotal positive results in China, CQ is now implemented in China and the Netherlands in moderate to severe COVID-19.","[{'ForeName': 'Jesper M', 'Initials': 'JM', 'LastName': 'Weehuizen', 'Affiliation': 'Department of Infectious Diseases, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Andy I M', 'Initials': 'AIM', 'LastName': 'Hoepelman', 'Affiliation': 'Department of Infectious Diseases, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands.'}]",European journal of clinical investigation,['10.1111/eci.13297']
3209,32476054,Acute exercise-related cognitive effects are not attributable to changes in end-tidal CO 2  or cerebral blood velocity.,"PURPOSE


Cognition, cerebral blood flow (CBF) and its major regulator (i.e., arterial CO 2 ), increase with submaximal exercise and decline with severe exercise. These responses may depend on fitness. We investigated whether exercise-related changes in cognition are mediated in part by concomitant changes in CBF and CO 2 , in ten active (26 ± 3 years) and ten inactive (24 ± 6 years) healthy adults.
METHODS


Participants completed two randomised sessions; exercise and a resting CO 2 -control-wherein end-tidal CO 2  (PETCO 2 ) was matched between sessions and clamped across conditions at exercise-associated increases (+ 3 mmHg) and hypercapnia (+ 10 mmHg). Exercise comprised inclined walking at submaximal and severe intensities. CBF was indexed using right middle cerebral artery blood velocity (MCAv). Cognition (visuomotor, switching and inhibitory response time) was measured before, during, and after exercise.
RESULTS


MCAv and its inverted-U response to exercise were comparable between groups, whereas visuomotor performance improved during submaximal exercise in the active group only (p = 0.046). Submaximal, but not severe (p = 0.33), exercise increased MCAv (p ≤ 0.03). Hypercapnia increased MCAv during the CO 2 -control (27 ± 12%) and during submaximal exercise (39 ± 17%; p < 0.01). Despite the acute increases in MCAv, cognition was impaired during both levels of increased PETCO 2  (3-6%; p ≤ 0.04), regardless of session. Overall, resting or exercise-related changes in PETCO 2  and MCAv did not associate with changes in cognition (r ≤ 0.29 ± 0.34). Fitness ([Formula: see text]O 2MAX ) was associated with baseline cognition (r ≥ 0.50).
CONCLUSION


Acute increases in PETCO 2  and MCAv were not associated with improved cognition. In fact, cognitive performance was impaired at both levels of increased PETCO 2 , regardless of session. Finally, fitter people were found to have better cognition.",2020,"Submaximal, but not severe (p = 0.33), exercise increased MCAv (p ≤ 0.03).","['ten active (26\u2009±\u20093\xa0years) and ten inactive (24\u2009±\u20096\xa0years) healthy adults', 'Participants completed two randomised']",['sessions; exercise and a resting CO 2 -control-wherein end-tidal CO 2  (PETCO 2 ) was matched between sessions and clamped across conditions at exercise-associated increases (+\u20093\xa0mmHg) and hypercapnia (+\u200910\xa0mmHg'],"['cognitive performance', 'MCAv, cognition', 'Cognition (visuomotor, switching and inhibitory response time', 'right middle cerebral artery blood velocity (MCAv', 'Hypercapnia increased MCAv', 'visuomotor performance', 'Overall, resting or exercise-related changes in PETCO 2  and MCAv', 'exercise increased MCAv', 'Cognition, cerebral blood flow (CBF']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0226213', 'cui_str': 'Structure of right middle cerebral artery'}, {'cui': 'C1531610', 'cui_str': 'Blood velocity'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}]",,0.0414652,"Submaximal, but not severe (p = 0.33), exercise increased MCAv (p ≤ 0.03).","[{'ForeName': 'Leena N', 'Initials': 'LN', 'LastName': 'Shoemaker', 'Affiliation': 'School of Physical Education, Sport and Exercise Sciences, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Luke C', 'Initials': 'LC', 'LastName': 'Wilson', 'Affiliation': 'Department of Medicine, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand. Luke.wilson@otago.ac.nz.'}, {'ForeName': 'Samuel J E', 'Initials': 'SJE', 'LastName': 'Lucas', 'Affiliation': 'Department of Physiology, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Liana', 'Initials': 'L', 'LastName': 'Machado', 'Affiliation': 'Department of Psychology, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Cotter', 'Affiliation': 'School of Physical Education, Sport and Exercise Sciences, University of Otago, Dunedin, New Zealand.'}]",European journal of applied physiology,['10.1007/s00421-020-04393-7']
3210,32484432,Carer administration of as-needed subcutaneous medication for breakthrough symptoms in people dying at home: the CARiAD feasibility RCT.,"BACKGROUND


Most people who are dying want to be cared for at home, but only half of them achieve this. The likelihood of a home death often depends on the availability of able and willing lay carers. When people who are dying are unable to take oral medication, injectable medication is used. When top-up medication is required, a health-care professional travels to the dying person's home, which may delay symptom relief. The administration of subcutaneous medication by lay carers, although not widespread UK practice, has proven to be key in achieving better symptom control for those dying at home in other countries.
OBJECTIVES


To determine if carer administration of as-needed subcutaneous medication for common breakthrough symptoms in people dying at home is feasible and acceptable in the UK, and if it would be feasible to test this intervention in a future definitive randomised controlled trial.
DESIGN


We conducted a two-arm, parallel-group, individually randomised, open pilot trial of the intervention versus usual care, with a 1 : 1 allocation ratio, using convergent mixed methods.
SETTING


Home-based care without 24/7 paid care provision, in three UK sites.
PARTICIPANTS


Participants were dyads of adult patients and carers: patients in the last weeks of their life who wished to die at home and lay carers who were willing to be trained to give subcutaneous medication. Strict risk assessment criteria needed to be met before approach, including known history of substance abuse or carer ability to be trained to competency.
INTERVENTION


Intervention-group carers received training by local nurses using a manualised training package.
MAIN OUTCOME MEASURES


Quantitative data were collected at baseline and 6-8 weeks post bereavement and via carer diaries. Interviews with carers and health-care professionals explored attitudes to, experiences of and preferences for giving subcutaneous medication and experience of trial processes. The main outcomes of interest were feasibility, acceptability, recruitment rates, attrition and selection of the most appropriate outcome measures.
RESULTS


In total, 40 out of 101 eligible dyads were recruited (39.6%), which met the feasibility criterion of recruiting > 30% of eligible dyads. The expected recruitment target (≈50 dyads) was not reached, as fewer than expected participants were identified. Although the overall retention rate was 55% (22/40), this was substantially unbalanced [30% (6/20) usual care and 80% (16/20) intervention]. The feasibility criterion of > 40% retention was, therefore, considered not met. A total of 12 carers (intervention,  n  = 10; usual care,  n  = 2) and 20 health-care professionals were interviewed. The intervention was considered acceptable, feasible and safe in the small study population. The context of the feasibility study was not ideal, as district nurses were seriously overstretched and unfamiliar with research methods. A disparity in readiness to consider the intervention was demonstrated between carers and health-care professionals. Findings showed that there were methodological and ethics issues pertaining to researching last days of life care.
CONCLUSION


The success of a future definitive trial is uncertain because of equivocal results in the progression criteria, particularly poor recruitment overall and a low retention rate in the usual-care group. Future work regarding the intervention should include understanding the context of UK areas where this has been adopted, ascertaining wider public views and exploring health-care professional views on burden and risk in the NHS context. There should be consideration of the need for national policy and of the most appropriate quantitative outcome measures to use. This will help to ascertain if there are unanswered questions to be studied in a trial.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN11211024.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 24, No. 25. See the NIHR Journals Library website for further project information.",2020,"To determine if carer administration of as-needed subcutaneous medication for common breakthrough symptoms in people dying at home is feasible and acceptable in the UK, and if it would be feasible to test this intervention in a future definitive randomised controlled trial.
","['Home-based care without 24/7 paid care provision, in three UK sites', 'In total, 40 out of 101 eligible dyads were recruited (39.6%), which met the feasibility criterion of recruiting >\u200930% of eligible dyads', '12 carers (intervention,  n \u2009=\u200910; usual care,  n \u2009=\u20092) and 20 health-care professionals were interviewed', 'people dying at home', 'Participants were dyads of adult patients and carers: patients in the last weeks of their life who wished to die at home and lay carers who were willing to be trained to give subcutaneous medication']","['Carer administration of as-needed subcutaneous medication', 'Intervention-group carers received training by local nurses using a manualised training package', 'intervention versus usual care, with a 1\u2009:\u20091 allocation ratio, using convergent mixed methods']","['overall retention rate', 'feasibility, acceptability, recruitment rates, attrition and selection of the most appropriate outcome measures']","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0729338', 'cui_str': 'Care provision regime'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}]",101.0,0.0884507,"To determine if carer administration of as-needed subcutaneous medication for common breakthrough symptoms in people dying at home is feasible and acceptable in the UK, and if it would be feasible to test this intervention in a future definitive randomised controlled trial.
","[{'ForeName': 'Marlise', 'Initials': 'M', 'LastName': 'Poolman', 'Affiliation': 'School of Health Sciences, Bangor University, Bangor, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Roberts', 'Affiliation': 'School of Health Sciences, Bangor University, Bangor, UK.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Wright', 'Affiliation': 'School of Health Sciences, Bangor University, Bangor, UK.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Hendry', 'Affiliation': 'School of Health Sciences, Bangor University, Bangor, UK.'}, {'ForeName': 'Nia', 'Initials': 'N', 'LastName': 'Goulden', 'Affiliation': 'North Wales Organisation for Randomised Trials in Health, Bangor University, Bangor, UK.'}, {'ForeName': 'Emily Af', 'Initials': 'EA', 'LastName': 'Holmes', 'Affiliation': 'School of Health Sciences, Bangor University, Bangor, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Byrne', 'Affiliation': 'Marie Curie Research Centre, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Perkins', 'Affiliation': 'Gloucestershire Hospitals NHS Foundation Trust, Gloucester, UK.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Hoare', 'Affiliation': 'North Wales Organisation for Randomised Trials in Health, Bangor University, Bangor, UK.'}, {'ForeName': 'Annmarie', 'Initials': 'A', 'LastName': 'Nelson', 'Affiliation': 'Marie Curie Research Centre, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Hiscock', 'Affiliation': 'School of Health Sciences, Bangor University, Bangor, UK.'}, {'ForeName': 'Dyfrig', 'Initials': 'D', 'LastName': 'Hughes', 'Affiliation': 'School of Health Sciences, Bangor University, Bangor, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': ""O'Connor"", 'Affiliation': 'Sue Ryder Leckhampton Court Hospice, Cheltenham, UK.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Foster', 'Affiliation': 'Public Contributor, North Wales Cancer Patient Forum, North Wales Cancer Treatment Centre, Bodelwyddan, UK.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Reymond', 'Affiliation': 'Brisbane South Palliative Care Collaborative, School of Medicine, Griffith University, Southport, QLD, Australia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Healy', 'Affiliation': 'Metro South Palliative Care Service, Brisbane, QLD, Australia.'}, {'ForeName': 'Penney', 'Initials': 'P', 'LastName': 'Lewis', 'Affiliation': ""Centre for Medical Law and Ethics, King's College London, London, UK.""}, {'ForeName': 'Bee', 'Initials': 'B', 'LastName': 'Wee', 'Affiliation': 'Harris Manchester College, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rosalynde', 'Initials': 'R', 'LastName': 'Johnstone', 'Affiliation': 'Betsi Cadwaladr University Health Board, Bangor, UK.'}, {'ForeName': 'Rossela', 'Initials': 'R', 'LastName': 'Roberts', 'Affiliation': 'School of Psychology, Bangor University, Bangor, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Parkinson', 'Affiliation': 'Sue Ryder Leckhampton Court Hospice, Cheltenham, UK.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Roberts', 'Affiliation': 'Betsi Cadwaladr University Health Board, Bangor, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Wilkinson', 'Affiliation': 'School of Health Sciences, Bangor University, Bangor, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24250']
3211,32481236,Acute responses of bone specific and related markers to maximal eccentric exercise of the knee extensors and flexors in young men.,"OBJECTIVES


The present study determined time-course changes in plasma bone-specific and -related markers following a bout of maximal eccentric contractions (MaxEC) of bilateral knee extensors (KE) and flexors (KF).
METHODS


Sedentary young men (n=30) performed a bout of 10 sets of 10 MaxEC (30°/s) of KE and KF with each leg, respectively. Maximal voluntary isometric contraction (MVC) torque, muscle soreness (SOR), plasma creatine kinase (CK) activity, insulin, leptin, tumor necrosis factor-α (TNF-α), undercarboxylated-osteocalcin (ucOCN), carboxy-terminal crosslinking telopeptide of type I collagen (CTX-1) and procollagen type I N-terminal propeptide (P1NP) concentrations were measured from before to 7 days after MaxEC.
RESULTS


Significant changes in MVC (KE: -28%, KF: -38%), SOR and plasma CK activity (peak: 39,163 IU/L) following MaxEC were evident (P<0.05) compared to baseline. Plasma leptin (17%) concentrations decreased at 1 day after MaxEC. In bone related markers, plasma ucOCN concentrations (20%) increased at 7 days after MaxEC, and plasma CTX-1 concentrations decreased at 2, 4 and 7 days after MaxEC (6~7%; P<0.05).
CONCLUSION


These results demonstrate that a lean effect of bone generation and an enhanced energy anabolism can be induced by a single bout of MaxEC.",2020,"concentrations decreased at 2, 4 and 7 days after MaxEC (6~7%; P<0.05).
","['Sedentary young men (n=30', 'young men']","['bone specific and related markers to maximal eccentric exercise', 'bilateral knee extensors (KE) and flexors (KF', 'I collagen (CTX-1) and procollagen type', 'maximal eccentric contractions (MaxEC']","['concentrations', 'plasma ucOCN concentrations', 'plasma CTX-1', 'Plasma leptin (17%) concentrations', 'Maximal voluntary isometric contraction (MVC) torque, muscle soreness (SOR), plasma creatine kinase (CK) activity, insulin, leptin, tumor necrosis factor-α (TNF-α), undercarboxylated-osteocalcin (ucOCN), carboxy-terminal crosslinking telopeptide of type', 'P1NP) concentrations', 'SOR and plasma CK activity']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0858114', 'cui_str': 'Plasma creatine'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}]",,0.0699251,"concentrations decreased at 2, 4 and 7 days after MaxEC (6~7%; P<0.05).
","[{'ForeName': 'Tsang-Hai', 'Initials': 'TH', 'LastName': 'Huang', 'Affiliation': 'Institute of Physical Education, Health and Leisure Studies, National Cheng Kung University, Tainan City, Taiwan.'}, {'ForeName': 'Jung-Charng', 'Initials': 'JC', 'LastName': 'Lin', 'Affiliation': 'Department of Physical Education, Chinese Culture University, Taipei City, Taiwan.'}, {'ForeName': 'Mi-Chia', 'Initials': 'MC', 'LastName': 'Ma', 'Affiliation': 'Department of Statistics, National Cheng Kung University, Tainan City, Taiwan.'}, {'ForeName': 'Tsung', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': 'Department of Public Health College of Medicine, National Cheng Kung University, Tainan City, Taiwan.'}, {'ForeName': 'Trevor C', 'Initials': 'TC', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei City, Taiwan.'}]",Journal of musculoskeletal & neuronal interactions,[]
3212,32481262,"Radiological diagnostic accuracy study comparing Lenke, Bridwell, BSF, and CT-HU fusion grading scales for minimally invasive lumbar interbody fusion spine surgery and its correlation to clinical outcome.","Prospective randomized double-blinded diagnostic accuracy study about radiological grading of fusion after minimally invasive lumbar interbody fusion procedures (MI-LIFP).To determinate the intra and the inter-observer correlation between different radiological lumbar interbody fusion grading scales (RLIFGS) in patients undergoing MI-LIFP and their correlation to clinical outcome.Besides technological improvements in medical diagnosis and the many existing RLIFGS, surgical exploration continues to be the gold-standard to assess fusion in patients with radiological pseudarthrosis, with little if any research on the relationship between RLIFGS and clinical outcome.We collected data from patients undergoing MI-LIFP procedures operated by a single surgeon from 2009 to 2017, which had follow-up and CT-scan control greater than 12 months, whose clinical registers specified lumbar and radicular visual analogue scale (L and R-VAS) and Oswestry Disability Index (ODI) score preoperatively and at the end of follow-up. Interbody fusion levels were coded for blinded evaluation by three different minimally invasive spine (MIS) surgeons, using Lenke, Bridwell, BSF (Brantigan, Steffe, Fraser), and CT-HU RLIFGS. We established fusion criteria, as described in their original papers. Another independent spine surgeon blindly evaluated successful clinical outcome (SCO), defined as a significant improvement in 2 of 3 of the following issues: L-VAS, R-VAS, or ODI score at follow-up; otherwise, rated as clinical pseudarthrosis. Radiological and clinical data was coded and statistically analyzed using Student T-Test, Pearson P-Test, and ANOVA with statistical package for the social sciences 21 by another blinded researcher, positive and negative predictive values were also calculated for each RLFGS.We found a significant clinical improvement with a moderate intra-observer correlation between scales and no inter-observer or clinical correlation, with no sub-group statistically significant differences.This paper represents the first study about the diagnostic accuracy of RLFGS, we concluded that their diagnostic accuracy is pretty low to determine fusion or pseudoarthrosis based on its low correlation to clinical outcome, we recommend surgeons rely on clinical findings to decide whether a patient has clinical fusion or pseudoarthrosis based on successful clinical outcome.",2020,"Another independent spine surgeon blindly evaluated successful clinical outcome (SCO), defined as a significant improvement in 2 of 3 of the following issues: L-VAS, R-VAS, or ODI score at follow-up; otherwise, rated as clinical pseudarthrosis.","['patients undergoing MI-LIFP procedures operated by a single surgeon from 2009 to 2017, which had follow-up and CT-scan control greater than 12 months, whose', 'patients undergoing MI-LIFP and their correlation to clinical outcome', 'patients with radiological pseudarthrosis']","['Lenke, Bridwell, BSF, and CT-HU fusion grading scales', 'RLFGS']","['successful clinical outcome (SCO', 'L-VAS, R-VAS, or ODI score', 'clinical registers specified lumbar and radicular visual analogue scale (L and R-VAS) and Oswestry Disability Index (ODI) score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C1293131', 'cui_str': 'Fusion'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0033785', 'cui_str': 'Pseudoarthrosis'}]","[{'cui': 'C0006463', 'cui_str': 'Busulfan'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C2960603', 'cui_str': 'Oswestry disability index score'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0349849,"Another independent spine surgeon blindly evaluated successful clinical outcome (SCO), defined as a significant improvement in 2 of 3 of the following issues: L-VAS, R-VAS, or ODI score at follow-up; otherwise, rated as clinical pseudarthrosis.","[{'ForeName': 'José Antonio', 'Initials': 'JA', 'LastName': 'Soriano Sánchez', 'Affiliation': 'Spine Clinic of The American-British Cowdray Medical Center IAP. Campus Santa Fe Mexican Association of Spine Surgeons (AMCICO) Mexican Society of Neurological Surgery (SMCN).'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Soriano Solís', 'Affiliation': 'Orthopedic Surgeon and Minimally Invasive Spine Surgeon of The American-British Cowdray Medical Center IAP., Campus Santa Fe.'}, {'ForeName': 'Manuel Eduardo', 'Initials': 'ME', 'LastName': 'Soto García', 'Affiliation': 'Neurosurgeon and Minimally Invasive Spine Surgeon of The American-British Cowdray Medical Center IAP., Campus Santa Fe.'}, {'ForeName': 'Héctor Antonio', 'Initials': 'HA', 'LastName': 'Soriano Solís', 'Affiliation': 'Orthopedic Surgeon of The American-British Cowdray Medical Center IAP., Campus Santa Fe.'}, {'ForeName': 'Briscia Yazmin Aranda', 'Initials': 'BYA', 'LastName': 'Torres', 'Affiliation': 'Student of Nutritional Sciences, University of Sonora (UNISON).'}, {'ForeName': 'José Alberto Israel', 'Initials': 'JAI', 'LastName': 'Romero Rangel', 'Affiliation': 'Neurosurgeon and Minimally Invasive Spine Surgeon of The American-British Cowdray Medical Center IAP. Campus Santa Fe Neurosurgeon of the Regional General Hospital #25, Mexican Institute of Social Security (HGR#25, IMSS).'}]",Medicine,['10.1097/MD.0000000000019979']
3213,32481275,Personalized electro-acupuncture versus auricular-acupuncture comparative effectiveness (PEACE): A protocol of a randomized controlled trial for chronic musculoskeletal pain in cancer survivors.,"INTRODUCTION


Chronic pain is a leading cause of disability and remains under-treated in nearly half of patients with cancer. The opioid crisis has highlighted an urgent public health need for effective nonpharmacological pain management. Electroacupuncture (EA) and Battlefield Acupuncture (BFA) represent nonpharmacological modalities used in clinical practice to manage pain; however, their effectiveness has not been rigorously evaluated in oncology settings.
METHODS


We describe the design of a 3-arm, parallel, single-center, multisite randomized controlled trial that investigates EA and BFA versus usual-care wait-list control (WLC) for chronic musculoskeletal pain among 360 patients with diverse cancer types across various stages. The primary aim is to compare effects of EA and BFA versus WLC on pain, physical function, and co-morbid symptoms. The secondary aim is to examine the interaction between patient outcome expectancy and acupuncture modality (EA vs BFA) on pain reduction. The tertiary aim is to evaluate the association between genetic polymorphisms and responses to acupuncture. Patients will be randomized in a 2:2:1 ratio to EA:BFA:WLC. Acupuncture groups will receive weekly treatments over 10 weeks. WLC will receive usual care over the same evaluation period as the acupuncture groups. The primary endpoint will be the change in average pain intensity score from baseline to week 12. We will collect validated patient-reported outcomes and blood/saliva samples at multiple timepoints over 24 weeks.
DISCUSSION


Our findings will advance nonpharmacological pain management in oncology and inform personalized treatment approaches that integrate individuals' expectations and genetic biomarkers to deliver ""precision"" acupuncture to cancer patients with chronic pain.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02979574.",2020,The secondary aim is to examine the interaction between patient outcome expectancy and acupuncture modality (EA vs BFA) on pain reduction.,"['360 patients with diverse cancer types across various stages', 'chronic musculoskeletal pain in cancer survivors', 'cancer patients with chronic pain', 'patients with cancer']","['acupuncture', 'EA and BFA versus usual-care wait-list control (WLC', 'EA and BFA versus WLC', 'Acupuncture', 'acupuncture modality (EA vs BFA', 'Personalized electro-acupuncture versus auricular-acupuncture comparative effectiveness (PEACE', 'Electroacupuncture (EA) and Battlefield Acupuncture (BFA', 'WLC']","['average pain intensity score', 'pain reduction', 'pain, physical function, and co-morbid symptoms']","[{'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0752217', 'cui_str': 'Ear Acupuncture'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",360.0,0.192384,The secondary aim is to examine the interaction between patient outcome expectancy and acupuncture modality (EA vs BFA) on pain reduction.,"[{'ForeName': 'Kevin T', 'Initials': 'KT', 'LastName': 'Liou', 'Affiliation': 'Integrative Medicine Service, Department of Medicine.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Baser', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Sally A D', 'Initials': 'SAD', 'LastName': 'Romero', 'Affiliation': 'Department of Family Medicine and Public Health, UC San Diego School of Medicine, San Diego, CA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Green', 'Affiliation': 'Integrative Medicine Service, Department of Medicine.'}, {'ForeName': 'Q Susan', 'Initials': 'QS', 'LastName': 'Li', 'Affiliation': 'Integrative Medicine Service, Department of Medicine.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Orlow', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Katherine S', 'Initials': 'KS', 'LastName': 'Panageas', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Jun J', 'Initials': 'JJ', 'LastName': 'Mao', 'Affiliation': 'Integrative Medicine Service, Department of Medicine.'}]",Medicine,['10.1097/MD.0000000000020085']
3214,32481277,The effect of Shexiang Tongxin Dropping Pills on coronary microvascular dysfunction (CMVD) among those with a mental disorder and non-obstructive coronary artery disease based on stress cardiac magnetic resonance images: A study protocol.,"INTRODUCTION


Coronary microvascular dysfunction (CMVD), highly prevalent among patients with a mental disorder (anxiety or depression), is closely related to adverse cardiac events, including hospitalization, sudden cardiac death, and myocardial infarction. Shexiang Tongxin Dropping Pills (STDP), a traditional Chinese medicine, exerts endothelial protective function by anti-inflammation, anti-oxidative stress, and promoting blood circulation. STDP protects against CMVD in previous fundamental studies. The present trial is aiming at evaluating the effect of STDP on CMVD among depressed or anxious patients with non-obstructive coronary artery disease (NOCAD).
METHODS AND ANALYSIS


Seventy-two depressed or anxious patients diagnosed with NOCAD combined with CMVD utilizing coronary artery angiography and stress cardiac magnetic resonance (CMR) will be recruited in the present study. These patients will be randomized into two groups, namely, Nicorandil group (Nicorandil combined with routine medicine), and STDP groups (STDP combined with routine medicine). The change of CMVD status by assessing absolute myocardial blood flow and myocardial reperfusion using stress CMR 3-month after discharge is defined as the primary endpoint. Major adverse cardiac events (MACEs), quality of life (QOL), and metal disorder improvement are defined as the secondary endpoints. Seattle angina questionnaire (SAQ) which is used to assess angina pectoris and QOL will be recorded at 1-, 3-, 6-, 9-, 12-month of follow-up. Seven-item Generalized Anxiety Disorder Scale (GAD-7) and 9-item depression module from the Patient Health Questionnaire (PHQ9) which utilized to evaluate anxiety and depression, respectively, will be recorded at 1-, 3-, 6-, 9-, 12-month of follow-up. This study will first evaluate the efficacy of STDP on CMVD among patients with a mental disorder and NOCAD, and discuss the potential mechanisms, providing therapeutic evidence for the STDP for these patients.",2020,The change of CMVD status by assessing absolute myocardial blood flow and myocardial reperfusion using stress CMR 3-month after discharge is defined as the primary endpoint.,"['anxious patients with non-obstructive coronary artery disease (NOCAD', 'patients with a mental disorder and NOCAD', 'those with a mental disorder and non-obstructive coronary artery disease', 'Seventy-two depressed or anxious patients diagnosed with NOCAD combined with CMVD utilizing coronary artery angiography and stress cardiac magnetic resonance (CMR', 'patients with a mental disorder (anxiety or depression']","['STDP', 'Shexiang Tongxin Dropping Pills', 'Nicorandil group (Nicorandil combined with routine medicine), and STDP groups (STDP combined with routine medicine', 'Shexiang Tongxin Dropping Pills (STDP']","['angina pectoris and QOL', 'Major adverse cardiac events (MACEs), quality of life (QOL), and metal disorder improvement', 'Seven-item Generalized Anxiety Disorder Scale (GAD-7) and 9-item depression module', 'Seattle angina questionnaire (SAQ', 'coronary microvascular dysfunction (CMVD']","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205304', 'cui_str': 'Non-obstructive'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3696962', 'cui_str': 'Coronary microvascular dysfunction'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C4079279', 'cui_str': 'shexiang tongxin'}, {'cui': 'C0440421', 'cui_str': 'Droppings'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0068700', 'cui_str': 'Nicorandil'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3696962', 'cui_str': 'Coronary microvascular dysfunction'}]",72.0,0.0481841,The change of CMVD status by assessing absolute myocardial blood flow and myocardial reperfusion using stress CMR 3-month after discharge is defined as the primary endpoint.,"[{'ForeName': 'Jinfan', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Department of Cardiology.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology.'}, {'ForeName': 'Xueyao', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Zuo', 'Affiliation': 'Department of Community Health Research, Beijing Anzhen Hospital, Capital Medical University.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiology.'}, {'ForeName': 'Jingwen', 'Initials': 'J', 'LastName': 'Yong', 'Affiliation': 'Department of Cardiology.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Radiology, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiantao', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': 'Department of Cardiology.'}]",Medicine,['10.1097/MD.0000000000020099']
3215,32481287,Clinical observation of Dan-Hong Hua-Yu oral solution in treating retinal vein occlusion.,"INTRODUCTION


Retinal vein occlusion refers to diseases with decreased vision, dilated tortuous retinal veins visible on the fundus, and retinal hemorrhage, edema, and osmosis distributed along the vein. There is still no ideal intervention to treat central retinal vein occlusion. This study plan to observe the efficacy of Dan-Hong Hua-Yu oral solution in treating non-ischemic retinal vein occlusion, in order to provide new treatment ideas.
METHODS/DESIGN


We plan to use random number table method, 64 cases of non-ischemic central retinal vein occlusion that meet the inclusion criteria will be randomly divided into a treatment group and a control group. The intervention group will be treated with Dan-Hong Hua-Yu oral solution according to the syndrome differentiation of Traditional Chinese medicine and the patient's fundus condition. Each group will take 4 weeks as a course of treatment and three consecutive courses of treatment without any interval during the course of treatment. Changes of visual acuity, fundus performance, and total clinical symptoms of patients before and after treatment will be observed.
DISCUSSION


This study will observe the efficacy of Dan-Hong Hua-Yu oral solution in the treatment of non-ischemic central retinal vein occlusion, with a view to providing new treatment ideas.
TRIAL REGISTRATION


ClinicalTrials.gov, ChiCTR2000030625, Registered on March 08, 2020.",2020,"This study will observe the efficacy of Dan-Hong Hua-Yu oral solution in the treatment of non-ischemic central retinal vein occlusion, with a view to providing new treatment ideas.
",['64 cases of non-ischemic central retinal vein occlusion that meet the inclusion criteria'],"['Dan-Hong Hua-Yu oral solution', ""Dan-Hong Hua-Yu oral solution according to the syndrome differentiation of Traditional Chinese medicine and the patient's fundus condition""]","['visual acuity, fundus performance, and total clinical symptoms']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0730361', 'cui_str': 'Central retinal vein occlusion - non-ischemic'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0010961', 'cui_str': 'Danazol'}, {'cui': 'C0991536', 'cui_str': 'Oral solution'}, {'cui': 'C1857276', 'cui_str': 'Trichohepatoenteric syndrome'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016823', 'cui_str': 'Structure of fundus of eye'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0016823', 'cui_str': 'Structure of fundus of eye'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0455749,"This study will observe the efficacy of Dan-Hong Hua-Yu oral solution in the treatment of non-ischemic central retinal vein occlusion, with a view to providing new treatment ideas.
","[{'ForeName': 'Tie-Jun', 'Initials': 'TJ', 'LastName': 'Li', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University.'}, {'ForeName': 'Yu-Chen', 'Initials': 'YC', 'LastName': 'Sun', 'Affiliation': 'Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China.'}, {'ForeName': 'Qiu-Yan', 'Initials': 'QY', 'LastName': 'Ma', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University.'}, {'ForeName': 'Ying-Xin', 'Initials': 'YX', 'LastName': 'Yang', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University.'}]",Medicine,['10.1097/MD.0000000000020173']
3216,32484940,Therapeutic index of inhaled corticosteroids in asthma: A dose-response comparison on airway hyperresponsiveness and adrenal axis suppression.,"AIMS


To compare the airway potency, systemic activity and therapeutic index of three inhaled corticosteroids that differ in glucocorticoid receptor binding affinity, physicochemical and pharmacokinetic properties.
METHODS


This escalating-dose, placebo-controlled, cross-over study randomised adults with asthma to 1 or 2 treatment periods with ≥25 days washout in-between. Each treatment period comprised five 7-day dose escalations (μg/d): fluticasone furoate (FF; 25 → 100 → 200 → 400 → 800), fluticasone propionate (FP; 50 → 200 → 500 → 1000 → 2000), budesonide (BUD; 100 → 400 → 800 → 1600 → 3200) or placebo. Airway hyperresponsiveness to adenosine-5'-monophosphate (AMP PC 20  ) was assessed on day 8. Plasma cortisol was assessed on day 1 (predose baseline) and from pre-PM dose on day 6 to pre-PM dose day 7 (24-h weighted mean).
RESULTS


Fifty-four subjects were randomised. FF showed greater airway potency than FP and BUD (AMP PC 20  dose at which 50% of the maximum effect is achieved [ED 50  ] values: 48.52, 1081.27 and 1467.36 μg/d, respectively). Systemic activity (cortisol suppression) ED 50  values were 899.99, 1986.05 and 1927.42 μg/d, respectively. The therapeutic index (ED 50  cortisol suppression/ED 50  AMP PC 20  ) was wider for FF (18.55) than FP (1.84) and BUD (1.31). FF 100 μg/d and 200 μg/d were both comparable in terms of airway potency with high doses of FP (≥1000 μg twice daily [BID]) and BUD (≥1500 μg/BID). The systemic activity of FF 100 μg/d and 200 μg/d (cortisol suppression: 7.41% and 14.28%, respectively) was comparable with low doses of FP (100 μg/BID and 250 μg/BID) and BUD (100 μg/BID and 200 μg/BID).
CONCLUSION


This study provides evidence that FF can provide more protection against airway hyperresponsiveness, with less systemic activity, than FP or BUD. This suggests that all inhaled corticosteroids are not therapeutically similar and may differ in their therapeutic index. (203162; NCT02991859).",2020,"FF showed greater airway potency than FP and BUD (AMP PC 20  ED 50  values: 48.52, 1081.27 and 1467.36μg/day, respectively).","['asthma', 'Fifty-four subjects were randomised', ""adults with asthma to one or two treatment periods with ≥25-days' washout in-between""]","['FF', 'fluticasone propionate', 'corticosteroids (ICS', 'FP', 'budesonide', 'inhaled corticosteroids', 'fluticasone furoate', 'placebo']","['systemic activity', 'Plasma cortisol', 'airway potency', 'Systemic activity (cortisol suppression', 'airway potency, systemic activity and therapeutic index']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1281899', 'cui_str': 'Plasma cortisol measurement'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0678793', 'cui_str': 'Therapeutic Index'}]",54.0,0.207423,"FF showed greater airway potency than FP and BUD (AMP PC 20  ED 50  values: 48.52, 1081.27 and 1467.36μg/day, respectively).","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Daley-Yates', 'Affiliation': 'Clinical Pharmacology and Experimental Medicine, GlaxoSmithKline plc, Uxbridge, UK.'}, {'ForeName': 'Noushin', 'Initials': 'N', 'LastName': 'Brealey', 'Affiliation': 'Clinical Pharmacology and Experimental Medicine, GlaxoSmithKline plc, Uxbridge, UK.'}, {'ForeName': 'Sebin', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': 'Biostatistics and Programming, GlaxoSmithKline plc, Bangalore, India.'}, {'ForeName': 'Daren', 'Initials': 'D', 'LastName': 'Austin', 'Affiliation': 'Clinical Pharmacology and Experimental Medicine, GlaxoSmithKline plc, Uxbridge, UK.'}, {'ForeName': 'Shaila', 'Initials': 'S', 'LastName': 'Shabbir', 'Affiliation': 'Medicines Research Centre, GlaxoSmithKline plc, Stevenage, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Harrison', 'Affiliation': 'Respiratory Research Unit, Nottingham NIHR Biomedical Research Centre, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Barnes', 'Affiliation': 'Global Medical Franchise, GlaxoSmithKline plc, Brentford, UK.'}]",British journal of clinical pharmacology,['10.1111/bcp.14406']
3217,32485778,Whole-body Electromyostimulation plus Caloric Restriction in Metabolic Syndrome.,"We investigated early effects of Whole-Body Electromyostimulation added to hypocaloric diet on metabolic syndrome features in sedentary middle-aged individuals. We randomly assigned 25 patients to Whole-Body Electromyostimulation plus caloric restriction or caloric restriction alone for 26 weeks. Anthropometrics, blood pressure, fasting glucose and insulin, HOMA-IR, glycated hemoglobin, lipids, uric acid, creatinphosphokynase, C-reactive protein were assessed. Body composition was evaluated with direct-segmental, multi-frequency Bioelectrical Impedance Analysis. Both groups lost approximately 10% of weight, with similar effects on waist circumference and fat mass. Change in free-fat mass was significantly different between groups (caloric restriction -1.5±0.2 vs. Whole-Body Electromyostimulation plus caloric restriction +1.1±0.4 kg, p=0.03). Whole-Body Electromyostimulation plus caloric restriction group experienced greater percent reductions in insulin (-45.5±4.4 vs. -28.2±3.6%, p=0.002), HOMA-IR (-51.3±3.2 vs. -25.1±1.8%, p=0.001), triglycerides (-22.5±2.9 vs. -4.1±1.6%, p=0.004) and triglycerides/HDL (p=0.028). Subjects trained with Whole-Body Electromyostimulation had also significant improvement in systolic pressure (138±4 vs. 126±7 mmHg, p=0.038). No discontinuations for adverse events occurred. In middle-aged sedentary subjects with the metabolic syndrome, Whole-Body Electromyostimulation with caloric restriction for 26 weeks can improve insulin-resistance and lipid profile compared to diet alone. Further studies are needed to ascertain long-term efficacy and feasibility of this approach in individuals with the metabolic syndrome.",2020,"Change in free-fat mass was significantly different between groups (caloric restriction -1.5±0.2 vs. Whole-Body Electromyostimulation plus caloric restriction +1.1±0.4 kg, p=0.03).","['middle-aged sedentary subjects with the metabolic syndrome', 'Metabolic Syndrome', 'individuals with the metabolic syndrome', 'sedentary middle-aged individuals']","['Whole-Body Electromyostimulation plus caloric restriction or caloric restriction alone', 'Whole-Body Electromyostimulation added to hypocaloric diet']","['triglycerides', 'insulin-resistance and lipid profile', 'systolic pressure', 'metabolic syndrome features', 'waist circumference and fat mass', 'Body composition', 'HOMA-IR', 'free-fat mass', 'triglycerides/HDL', 'adverse events', 'Anthropometrics, blood pressure, fasting glucose and insulin, HOMA-IR, glycated hemoglobin, lipids, uric acid, creatinphosphokynase, C-reactive protein']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",25.0,0.0367421,"Change in free-fat mass was significantly different between groups (caloric restriction -1.5±0.2 vs. Whole-Body Electromyostimulation plus caloric restriction +1.1±0.4 kg, p=0.03).","[{'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Bellia', 'Affiliation': 'Department of Systems Medicine, University of Rome Tor Vergata, Roma, Italy.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Ruscello', 'Affiliation': 'School of Sports and Exercise Sciences, Telematic University San Raffaele Rome Srl, Roma, Italy.'}, {'ForeName': 'Rolando', 'Initials': 'R', 'LastName': 'Bolognino', 'Affiliation': 'Sapienza University of Rome, Unitelma Sapienza, Roma, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Briotti', 'Affiliation': 'School of Sports and Exercise Sciences, Telematic University San Raffaele Rome Srl, Roma, Italy.'}, {'ForeName': 'Paolo Roberto', 'Initials': 'PR', 'LastName': 'Gabrielli', 'Affiliation': 'School of Sports and Exercise Sciences , University of Rome Tor Vergata, Roma, Italy.'}, {'ForeName': 'Adriano', 'Initials': 'A', 'LastName': 'Silvestri', 'Affiliation': 'Urban Fitness EMS Institute, Urban Fitness, Milano, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Rosazza', 'Affiliation': 'Fondazione IRCCS Istituto Neurologico ""Carlo Besta"", Neuroradiology Dept., Milano, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Ambruoso', 'Affiliation': 'Faculty of Medicine and Surgery, School of Sports and Exercise Sciences, University of Rome Tor Vergata, Roma, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Lombardo', 'Affiliation': 'Department of Human Sciences and Promotion of the Quality of Life, Telematic University San Raffaele Rome Srl, Roma, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bernardini', 'Affiliation': 'Faculty of Medicine and Surgery, School of Sports and Exercise Sciences, University of Rome Tor Vergata, Roma, Italy.'}, {'ForeName': 'Cosimo', 'Initials': 'C', 'LastName': 'Calabrese', 'Affiliation': 'Department of Clinical Sciences and Translational Medicine, University of Rome Tor Vergata, Roma, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Lauro', 'Affiliation': 'Department of Systems Medicine, University of Rome Tor Vergata, Roma, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': ""D'Ottavio"", 'Affiliation': 'School of Sports and Exercise Sciences, Telematic University San Raffaele Rome Srl, Roma, Italy.'}]",International journal of sports medicine,['10.1055/a-1171-2003']
3218,32472296,Carotid plaques in adult rheumatoid arthritis patients; association with paroxonase 1 enzymatic activity and Q192R paroxonase 1 gene polymorphism.,"Paroxonase 1 (PON 1) enzymatic activity and Q192R PON polymorphism has been implicated with greater cardiovascular risk in general population. Rheumatoid arthritis (RA) is a systemic autoimmune disease characterized with increased inflammatory markers leading to increased cardiovascular morbidity. The aim of the work was to study association between PON1 enzymatic activity & gene polymorphism with carotid plaques in RA patients. This case-control study was carried out at Zagazig University Hospitals on 99 subjects divided randomly into two groups; 48 RA patients and 51 controls. RA patients fulfilled the revised 2010 EULAR/ACR classification criteria of RA. All patients were subjected to history taking, clinical evaluation, laboratory investigations & plain X-rays. Carotid intima-media thickness (CIMT) and PON1 enzyme assay & genotyping were done for both groups. PON1 enzyme levels were significantly higher in patients than controls. Also, there was a significant negative correlation of PON1 enzyme activity with increased CIMT & plaques. The cut-off value of PON1 enzyme level that had the highest CVD prediction was 4.2 U/ml. Although PON1 genotyping was insignificantly different between patients and controls, patients with QQ genotype had the lowest PON1 activity then patients with QR genotype then RR genotype. In RA patients, decreased serum PON1 enzymatic activity and QQ genotyping of Q192R PON polymorphism was associated with increased CIMT & plaques. Serum PON1 could be a good marker for atherosclerosis prediction in RA patients at cutoff 4.2 U/ml.",2020,"Although PON1 genotyping was insignificantly different between patients and controls, patients with QQ genotype had the lowest PON1 activity then patients with QR genotype then RR genotype.","['adult rheumatoid arthritis patients', 'RA patients', 'Zagazig University Hospitals on 99 subjects divided randomly into two groups; 48 RA patients and 51 controls']",[],"['serum PON1 enzymatic activity and QQ genotyping of Q192R PON polymorphism', 'PON1 enzyme levels', 'Carotid plaques', 'PON1 enzyme activity', 'lowest PON1 activity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0032639', 'cui_str': 'Pontine structure'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C0014440', 'cui_str': 'Enzyme measurement'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0243102', 'cui_str': 'enzyme activity'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",99.0,0.0203109,"Although PON1 genotyping was insignificantly different between patients and controls, patients with QQ genotype had the lowest PON1 activity then patients with QR genotype then RR genotype.","[{'ForeName': 'Essam Tawfik', 'Initials': 'ET', 'LastName': 'Atwa', 'Affiliation': 'Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Atef Goda', 'Initials': 'AG', 'LastName': 'Hussin', 'Affiliation': 'Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Mona Rabie', 'Initials': 'MR', 'LastName': 'Mohamed', 'Affiliation': 'Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Heba Fouad', 'Initials': 'HF', 'LastName': 'Pasha', 'Affiliation': 'Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Hammad', 'Affiliation': 'Faculty of Medicine, Zagazig University, Zagazig, Egypt. Marwahany22@hotmail.com.'}]",Molecular biology reports,['10.1007/s11033-020-05558-5']
3219,32469811,Endogenous cortisol-related alterations of right anterior insula functional connectivity under acute stress.,"BACKGROUND


Previous studies have suggested that the right anterior insula (rAI) plays a vital role in salience processing and stress-related disorders. In this study, we aimed to investigate the relationship between rAI functional connectivity changes and individual differences in cortisol responses after acute stress, in order to provide insights into psychiatric illness vulnerabilities.
METHODS


Thirty-five young men were enrolled in a randomized, counterbalanced two-session study, with aversive movie clip combined with electrical shocks as stress stimulation and the neutral movie clip as control stimulation. Resting-state fMRI data was acquired after movie exposure. The rAI was chosen as seed for functional connectivity analysis. We then examined the effect of acute stress on rAI functional connectivity and its association with individuals' cortisol response.
RESULTS


We found decreased rAI functional connectivity in the fronto-parietal regions, but increased functional connectivity in the visual and somatosensory areas following acute stress. Moreover, stress-induced cortisol response was significantly positively correlated with the rAI functional connectivity in the medial prefrontal cortex, and negatively correlated with the orbital-frontal cortex, lingual gyrus, and middle temporal gyrus.
LIMITATIONS


Only young Chinese males without any trauma experience were recruited in this study.
CONCLUSIONS


The results suggested tight link between specific rAI functional connectivity alterations and individual stress reactivity, which may help elucidate the potential neurobiological mechanism underlying vulnerability to stress-related disorders.",2020,"We found decreased rAI functional connectivity in the fronto-parietal regions, but increased functional connectivity in the visual and somatosensory areas following acute stress.","['Only young Chinese males without any trauma experience', 'Thirty-five young men']",['aversive movie clip combined with electrical shocks as stress stimulation and the neutral movie clip as control stimulation'],"['stress-induced cortisol response', 'orbital-frontal cortex, lingual gyrus, and middle temporal gyrus', 'functional connectivity', 'rAI functional connectivity']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0681495', 'cui_str': 'Movies'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013781', 'cui_str': 'Exposure to electric current, with passage of current through tissue'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0699036', 'cui_str': 'Orbital'}, {'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}, {'cui': 'C0152308', 'cui_str': 'Structure of lingual gyrus'}, {'cui': 'C0152310', 'cui_str': 'Structure of middle temporal gyrus'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441997', 'cui_str': 'Right anterior'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}]",35.0,0.0233179,"We found decreased rAI functional connectivity in the fronto-parietal regions, but increased functional connectivity in the visual and somatosensory areas following acute stress.","[{'ForeName': 'Yuyang', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Institute of Radiation Medicine, Academy of Military Medical Sciences, Beijing, 100850, China; Institute of Military Cognition and Brain Sciences, Academy of Military Medical Sciences, Beijing, 100850, China.'}, {'ForeName': 'Yituo', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Seventh Medical Center of the Chinese PLA General Hospital, Beijing, 100700, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Institute of Military Cognition and Brain Sciences, Academy of Military Medical Sciences, Beijing, 100850, China.'}, {'ForeName': 'Lubin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Institute of Military Cognition and Brain Sciences, Academy of Military Medical Sciences, Beijing, 100850, China. Electronic address: wanglb@bmi.ac.cn.'}, {'ForeName': 'Xiangjun', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Institute of Radiation Medicine, Academy of Military Medical Sciences, Beijing, 100850, China. Electronic address: xjhu2003@vip.sina.com.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.123']
3220,32469835,"The effectiveness of modified, group-based CBT for dementia worry among Chinese elders.","OBJECTIVES


Dementias are highly prevalent among Chinese elders. This study examined the effectiveness of a modified group cognitive behavioral therapy (CBT) on dementia worry among Chinese older adults.
METHODS


Eighty-two older adults recruited from four elder group homes were randomly assigned to either intervention or control group. The intervention group (n= 44) received eight weekly 60-minute face-to-face CBT, while the control group (n=38) received treatment-as-usual.
RESULTS


Outcomes indicated that the modified group CBT has significantly reduced dementia worry and culturally biased beliefs about dementia (p<.001). Study findings supported both statistically and clinically significant effect of modified group CBT on dementia worry [g=-1.52, 95% CI (-2.01, -1.03)] and biased beliefs about dementia [g=-.95, 95% CI (-1.40, -.49)].
DISCUSSION


The culturally adapted CBT is promising in alleviating worries and anxiety over dementia among Chinese older adults. Future research needs to include larger samples and participants from different regions to replicate findings.",2020,"RESULTS


Outcomes indicated that the modified group CBT has significantly reduced dementia worry and culturally biased beliefs about dementia (p<.001).","['Eighty-two older adults recruited from four elder group homes', 'Chinese elders', 'Chinese older adults']","['eight weekly 60-minute face-to-face CBT, while the control group (n=38) received treatment-as-usual', 'modified, group-based CBT', 'modified group cognitive behavioral therapy (CBT']","['dementia worry', 'dementia worry and culturally biased beliefs about dementia']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0018257', 'cui_str': 'Group Homes'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",82.0,0.0313174,"RESULTS


Outcomes indicated that the modified group CBT has significantly reduced dementia worry and culturally biased beliefs about dementia (p<.001).","[{'ForeName': 'Qiuling', 'Initials': 'Q', 'LastName': 'An', 'Affiliation': 'East China Normal University, School of Social Development, 500 DongChuan Rd., Shanghai, China.'}, {'ForeName': 'Kaipeng', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'University of Denver, Graduate School of Social Work, Denver, CO, USA. Electronic address: Kaipeng.Wang@du.edu.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': 'Michigan State University, School of Social Work, East Lansing, MI, USA.'}, {'ForeName': 'Anao', 'Initials': 'A', 'LastName': 'Zhang', 'Affiliation': 'University of Michigan, School of Social Work, Ann Arbor, MI, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.054']
3221,32469838,"Repeated transcranial direct current stimulation of dorsolateral-prefrontal cortex improves executive functions, cognitive reappraisal emotion regulation, and control over emotional processing in borderline personality disorder: A randomized, sham-controlled, parallel-group study.","BACKGROUND


Borderline personality disorder (BPD) is primarily characterized by deficient emotion regulation. Impaired cognitive control over negative emotions is central to emotion dysregulation in BPD. Respective executive dysfunctions are associated with hypoactivation of prefrontal regions, and consecutive alterations of fronto-limbic network functionality. Here, we investigated the effect of increasing activity of the dorsolateral prefrontal cortex (DLPFC) with repeated transcranial direct current stimulation (tDCS) on (1) executive dysfunctions and (2) whether improving cognitive control affects emotion dysregulation and emotional processing in BPD.
METHODS


Thirty-two patients diagnosed with BPD were randomly assigned to active stimulation (N = 16) or sham stimulation (N = 16) group in a randomized, sham-controlled, parallel-group design. They received 10 sessions of active (2 mA, 20 min, anodal left- cathodal right DLPFC) or sham tDCS over 10 days. Major executive functions, emotion regulation strategies, and emotional processing of the patients were assessed before and immediately after the intervention.
RESULTS


The active stimulation group showed a significant improvement in major executive function domains. Importantly, cognitive reappraisal strategy of emotion regulation and several factors of emotional processing involved in the control of emotion significantly improved in the active stimulation group after the intervention. Factors related to emotional expression were, however, not affected.
LIMITATIONS


The single-blind design, absence of follow-up measures, and the intrinsically limited focality of tDCS are limitations of this study.
CONCLUSIONS


Increasing activity of the DLPFC improves executive functioning in BPD and improves ´cognitive control over negative emotions. Cognitive control interventions could be a potential, symptom-driven therapeutic approach in BPD.",2020,"Respective executive dysfunctions are associated with hypoactivation of prefrontal regions, and consecutive alterations of fronto-limbic network functionality.","['borderline personality disorder', 'Thirty-two patients diagnosed with BPD', 'Borderline personality disorder (BPD']","['10 sessions of active (2\xa0mA, 20\xa0min, anodal left', 'repeated transcranial direct current stimulation (tDCS', 'cathodal right DLPFC) or sham tDCS', 'Cognitive control interventions', 'transcranial direct current stimulation of dorsolateral-prefrontal cortex', 'active stimulation (N\xa0=\xa016) or sham stimulation']","['emotional expression', 'major executive function domains', 'Major executive functions, emotion regulation strategies, and emotional processing', 'executive functions, cognitive reappraisal emotion regulation']","[{'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",32.0,0.096733,"Respective executive dysfunctions are associated with hypoactivation of prefrontal regions, and consecutive alterations of fronto-limbic network functionality.","[{'ForeName': 'Parviz', 'Initials': 'P', 'LastName': 'Molavi', 'Affiliation': 'Department of Psychiatry, Fatemi Hospital, School of Medicine, Ardabil University of Medical Science, Ardabil, Iran.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Aziziaram', 'Affiliation': 'Department of Psychology, University of Mohaghegh Ardabili, Ardabil, Iran.'}, {'ForeName': 'Sajjad', 'Initials': 'S', 'LastName': 'Basharpoor', 'Affiliation': 'Department of Psychology, University of Mohaghegh Ardabili, Ardabil, Iran. Electronic address: basharpoor_sajjad@uma.ac.ir.'}, {'ForeName': 'Akbar', 'Initials': 'A', 'LastName': 'Atadokht', 'Affiliation': 'Department of Psychology, University of Mohaghegh Ardabili, Ardabil, Iran.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nitsche', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Institute for Working Environment and Human Factors, Dortmund, Germany; University Medical Hospital Bergmannsheil, Department of Neurology, Bochum, Germany.'}, {'ForeName': 'Mohammed Ali', 'Initials': 'MA', 'LastName': 'Salehinejad', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Institute for Working Environment and Human Factors, Dortmund, Germany; Ruhr-University Bochum, International Graduate School of Neuroscience, Bochum, Germany. Electronic address: salehinejad@ifado.de.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.007']
3222,32470531,The high-risk ECG pattern of ST-elevation myocardial infarction: A substudy of the randomized trial of primary PCI with or without routine manual thrombectomy (TOTAL trial).,"BACKGROUND


Useful tools for risk assessment in patients with STEMI are needed. We evaluated the prognostic impact of the evolving myocardial infarction (EMI) and the preinfarction syndrome (PIS) ECG patterns and determined their correlation with angiographic findings and treatment strategy.
METHODS


This substudy of the randomized Trial of Routine Aspiration Thrombectomy with PCI versus PCI Alone in Patients with STEMI (TOTAL) included 7860 patients with STEMI and either the EMI or the PIS ECG pattern. The primary outcome was a composite of death from cardiovascular causes, recurrent MI, cardiogenic shock, or New York Heart Association (NYHA) class IV heart failure within one year.
RESULTS


The primary outcome occurred in 271 of 2618 patients (10.4%) in the EMI group vs. 322 of 5242 patients (6.1%) in the PIS group [AdjustedHR, 1.54; 95% CI, 1.30 to 1.82; p < .001]. The primary outcome occurred in the thrombectomy and PCI alone groups in 131 of 1306 (10.0%) and 140 of 1312 (10.7%) patients with EMI [HR 0.94; 95% CI, 0.74-1.19] and 162 of 2633 (6.2%) and 160 of 2609 (6.1%) patients with PIS [HR 1.00; 95% CI, 0.81-1.25], respectively (p interaction  = 0.679).
CONCLUSIONS


Patients with the EMI ECG pattern proved to have an increased rate of the primary outcome within one year compared to the PIS pattern. Routine manual thrombectomy did not reduce the risk of primary outcome within the different dynamic ECG patterns. The PIS/EMI dynamic ECG classification could help to triage patients in case of simultaneous STEMI patients with immediate need for pPCI.",2020,Routine manual thrombectomy did not reduce the risk of primary outcome within the different dynamic ECG patterns.,"['ST-elevation myocardial infarction', 'patients with STEMI', 'Patients with STEMI (TOTAL) included 7860 patients with STEMI and either the EMI or the PIS ECG pattern']","['PCI versus PCI Alone', 'primary PCI with or without routine manual thrombectomy']","['composite of death from cardiovascular causes, recurrent MI, cardiogenic shock, or New York Heart Association (NYHA) class IV heart failure within one year']","[{'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332253', 'cui_str': 'Evolving'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0086666', 'cui_str': 'Preinfarction syndrome'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441888', 'cui_str': 'Class 4'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C4082117', 'cui_str': 'One year'}]",7860.0,0.0957483,Routine manual thrombectomy did not reduce the risk of primary outcome within the different dynamic ECG patterns.,"[{'ForeName': 'Joonas', 'Initials': 'J', 'LastName': 'Leivo', 'Affiliation': 'Heart Center, Department of Cardiology, Tampere University Hospital, Finland; Faculty of Medicine and Health Technology, Tampere University, Finnish Cardiovascular Research Center, Tampere, Finland. Electronic address: joonas.leivo@fimnet.fi.'}, {'ForeName': 'Eero', 'Initials': 'E', 'LastName': 'Anttonen', 'Affiliation': 'Heart Center, Department of Cardiology, Tampere University Hospital, Finland; Faculty of Medicine and Health Technology, Tampere University, Finnish Cardiovascular Research Center, Tampere, Finland.'}, {'ForeName': 'Sanjit S', 'Initials': 'SS', 'LastName': 'Jolly', 'Affiliation': 'Population Health Research Institute, Hamilton, Canada; Department of Medicine, McMaster University, Hamilton, Canada; Hamilton Health Sciences, Hamilton, Canada.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Dzavik', 'Affiliation': 'Peter Munk Cardiac Centre, University Health Network, Toronto, Canada.'}, {'ForeName': 'Jyri', 'Initials': 'J', 'LastName': 'Koivumäki', 'Affiliation': 'Heart Center, Department of Cardiology, Tampere University Hospital, Finland.'}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Tahvanainen', 'Affiliation': 'Heart Center, Department of Cardiology, Tampere University Hospital, Finland.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Koivula', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University, Finnish Cardiovascular Research Center, Tampere, Finland; Internal medicine, Helsinki University Hospital, Finland.'}, {'ForeName': 'Kjell', 'Initials': 'K', 'LastName': 'Nikus', 'Affiliation': 'Heart Center, Department of Cardiology, Tampere University Hospital, Finland; Faculty of Medicine and Health Technology, Tampere University, Finnish Cardiovascular Research Center, Tampere, Finland.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Population Health Research Institute, Hamilton, Canada; Department of Medicine, McMaster University, Hamilton, Canada; David Braley Cardiac, Vascular and Stroke Research Institute, Hamilton, Canada.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Cairns', 'Affiliation': 'University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Niemelä', 'Affiliation': 'Heart Center, Department of Cardiology, Tampere University Hospital, Finland.'}, {'ForeName': 'Markku J', 'Initials': 'MJ', 'LastName': 'Eskola', 'Affiliation': 'Heart Center, Department of Cardiology, Tampere University Hospital, Finland; Faculty of Medicine and Health Technology, Tampere University, Finnish Cardiovascular Research Center, Tampere, Finland.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.05.053']
3223,32470574,Pharmacokinetic and bioequivalence study of new S-1 capsule in Chinese cancer patients.,"S-1 is a multicomponent capsule containing tegafur, gimeracil, and oteracil potassium that has shown anticancer activity against numerous tumor types. However, S-1 capsules from different manufacturing companies have shown variations in pharmacokinetics and safety. Therefore, this multicenter, single-dose, randomized-sequence, open-label, two-way, self-crossover study was conducted to evaluate the bioequivalence of a newly developed generic S-1 (New Times Pharmaceutical Co., Ltd., Shandong, China) and the original brand-name S-1 capsule (Taiho Pharmaceutical Co., Ltd., Japan). Furthermore, the safety profiles of both products were compared. A total of 70 patients with 18 types cancer including breast, lung, gastric, and colorectal recruited at 5 hospitals who were randomly and alternatively administered 50 mg of the reference and test S-1 with a 7-day interval. Plasma concentrations of tegafur, 5-chloro-2,4-dihydroxypyridine (CDHP), oteracil potassium, and 5-fluorouracil were detected using liquid chromatography-tandem mass spectrometry (LC-MS/MS). Pharmacokinetic parameters, including maximum drug concentration (C max ), time to achieve C max  (T max ), half-life (t 1/2 , area under the concentration-time curve from 0-time t (AUC 0-t ), and AUC from 0-infinity (AUC 0-∞ ) were determined using non-compartmental analysis with DAS2.0 software. Bioequivalence of the reference and test S-1 was evaluated according to 90% confidence intervals (CIs) for ratios of AUC and C max  of S-1. Adverse events were evaluated by monitoring symptoms, physical and laboratory examinations, electrocardiogram, and subject interviews. No significant difference was observed in plasma concentrations and pharmacokinetic profiles of tegafur, CDHP, oteracil potassium, or 5-fluorouracil (p > 0.05) among cancer patients treated with the reference or test S-1 formulation. The 90% CIs of C max , AUC 0-t , and AUC 0-∞  ratios were within the 80%-125% limit. The generic S-1 caused eight mild adverse events including liver dysfunction, diarrhea, nausea, fatigue, abnormal blood electrolytes, hyperglycemia, and dermal toxicity. Similarly, 18 mild adverse events were observed including dysarteriotony, diarrhea, nausea, fatigue, fever, hematotoxicity, abnormal blood electrolytes, hyperglycemia, dermal toxicity, and joint pain. There were no differences in the adverse event incidence between the two formulations. In conclusion, the newly developed generic S-1 showed similar pharmacokinetics to those of an original brand-name S-1 in cancer patients, thereby indicating bioequivalence. Furthermore, both treatments were well tolerated, suggesting that the cost-effective generic S-1 should be considered as a feasible option when treating patients.",2020,"No significant difference was observed in plasma concentrations and pharmacokinetic profiles of tegafur, CDHP, oteracil potassium, or 5-fluorouracil (p > 0.05) among cancer patients treated with the reference or test S-1 formulation.","['Chinese cancer patients', '70 patients with 18 types cancer including breast, lung, gastric, and colorectal recruited at 5 hospitals']",['new S-1 capsule'],"['adverse event incidence', 'liver dysfunction, diarrhea, nausea, fatigue, abnormal blood electrolytes, hyperglycemia, and dermal toxicity', 'pharmacokinetics and safety', 'Adverse events', 'Plasma concentrations of tegafur, 5-chloro-2,4-dihydroxypyridine (CDHP), oteracil potassium, and 5-fluorouracil', 'dysarteriotony, diarrhea, nausea, fatigue, fever, hematotoxicity, abnormal blood electrolytes, hyperglycemia, dermal toxicity, and joint pain', 'monitoring symptoms, physical and laboratory examinations, electrocardiogram, and subject interviews', 'maximum drug concentration (C max ), time to achieve C max  (T max ), half-life (t 1/2 , area under the concentration-time curve from 0-time t (AUC 0-t ), and AUC from 0-infinity (AUC 0-∞ ', 'plasma concentrations and pharmacokinetic profiles of tegafur, CDHP, oteracil potassium, or 5-fluorouracil']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0086565', 'cui_str': 'Abnormal liver function'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0853360', 'cui_str': 'Blood electrolytes'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0016778', 'cui_str': 'Tegafur'}, {'cui': 'C0535459', 'cui_str': 'Gimeracil'}, {'cui': 'C0393003', 'cui_str': 'potassium oxonate'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0920103', 'cui_str': 'Haematotoxicity'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0260877', 'cui_str': 'Laboratory examination'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",70.0,0.0538582,"No significant difference was observed in plasma concentrations and pharmacokinetic profiles of tegafur, CDHP, oteracil potassium, or 5-fluorouracil (p > 0.05) among cancer patients treated with the reference or test S-1 formulation.","[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Qu', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Qiming', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Internal Medicine, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Yuxian', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Department of Gastrointestinal Oncology, Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Oncology, Linyi Cancer Hospital, Linyi, China.'}, {'ForeName': 'Yehui', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Phase I Clinical Trial Department of Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Nong', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Jianfu', 'Initials': 'J', 'LastName': 'Heng', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China. Electronic address: hengjianfu@hnca.org.cn.'}, {'ForeName': 'Kunyan', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China. Electronic address: lkunyan@163.com.'}]",European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences,['10.1016/j.ejps.2020.105384']
3224,32470635,Evaluation of safety and efficacy of coronary intravascular lithotripsy for treatment of severely calcified coronary stenoses: Design and rationale for the Disrupt CAD III trial.,"Coronary calcification limits optimal stent expansion and apposition and worsens safety and effectiveness outcomes of percutaneous coronary intervention (PCI). Current ablative technologies that modify calcium to optimize stent deployment are limited by guidewire bias and periprocedural complications related to atheroembolization, coronary dissection, and perforation. Intravascular lithotripsy (IVL) delivers pulsatile ultrasonic pressure waves through a fluid-filled balloon into the vessel wall to modify calcium and enhance vessel compliance, reduce fibroelastic recoil, and decrease the need for high-pressure balloon (barotrauma) inflations. IVL has been used in peripheral arteries as stand-alone revascularization or as an adjunct to optimize stent deployment. STUDY DESIGN AND OBJECTIVES: Disrupt CAD III (clinicaltrials.gov identifier: NCT03595176) is a prospective, multicenter, single-arm study designed to assess safety and efficacy of the Shockwave coronary IVL catheter to optimize coronary stent deployment in patients with de novo calcified coronary stenoses. The primary safety end point is freedom from major adverse cardiovascular events (composite of cardiac death, myocardial infarction, and target vessel revascularization) at 30 days compared to a prespecified performance goal. The primary effectiveness end point is procedural success without in-hospital major adverse cardiovascular events. Enrollment will complete early in 2020 with clinical follow-up ongoing for 2 years. CONCLUSION: Disrupt CAD III will evaluate the safety and effectiveness of the Shockwave coronary IVL catheter to optimize coronary stent deployment in patients with calcified coronary stenoses.",2020,Coronary calcification limits optimal stent expansion and apposition and worsens safety and effectiveness outcomes of percutaneous coronary intervention (PCI).,"['severely calcified coronary stenoses', 'patients with de novo calcified coronary stenoses', 'patients with calcified coronary stenoses']","['coronary intravascular lithotripsy', 'Intravascular lithotripsy (IVL', 'Shockwave coronary IVL catheter', 'percutaneous coronary intervention (PCI']","['procedural success without in-hospital major adverse cardiovascular events', 'safety and efficacy', 'freedom from major adverse cardiovascular events (composite of cardiac death, myocardial infarction, and target vessel revascularization']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0242231', 'cui_str': 'Coronary artery stenosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",,0.0335608,Coronary calcification limits optimal stent expansion and apposition and worsens safety and effectiveness outcomes of percutaneous coronary intervention (PCI).,"[{'ForeName': 'Dean J', 'Initials': 'DJ', 'LastName': 'Kereiakes', 'Affiliation': 'The Christ Hospital and Lindner Research Center, Cincinnati, OH. Electronic address: Lindner@thechristhospital.com.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Hill', 'Affiliation': 'Royal Brompton Hospital, London, United Kingdom.'}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Ben-Yehuda', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, NY; New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Maehara', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, NY; New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Beaux', 'Initials': 'B', 'LastName': 'Alexander', 'Affiliation': 'Shockwave Medical, Santa Clara, CA.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, NY; New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY.'}]",American heart journal,['10.1016/j.ahj.2020.04.005']
3225,32473556,Functional training with blood occlusion influences muscle quality indices in older adults.,"OBJECTIVES


This study aimed to determine if functional training with blood flow restriction (BFR) has a greater effect on muscle quality indices and performance of older men when compared to functional training without BFR.
MATERIALS AND METHODS


Thirty men (67.7 ± 5.8 years) were randomly assigned to one of the following three groups: functional training (FT), functional training with blood flow restriction (FTBFR), and control (C). Participants in both experimental groups trained three sessions per week for six weeks. The training program included eleven body exercises, which were performed in 2-4 sets of 10 repetitions. FTBFR group wore pneumatic cuffs on their extremities that begun with 50 % of estimated arterial occlusion pressure and increased by 10 % every 2 weeks. Before and after the intervention period, subjects completed a series of tests to assess physical performances along with changes serum muscle quality indices.
RESULTS


A significant decrease in serum C-terminal Agrin Fragment (CAF) levels were observed in FT and FTBFR groups (p ≤ 0.05). In addition, the levels of CAF in FTBFR group was significantly lower compared to control group. Moreover, the circulatory levels of N-terminal propeptide type III collagen (P3NP) were reduced significantly in FT and C groups (p ≤ 0.05) but did not statistically differ from baseline in FTBFR group (p > 0.05). These changes were accompanied by significant improvements in dynamic strength, flexibility, static, and dynamic balance in both training groups (p ≤ 0.01).
CONCLUSIONS


The finding showed greater improvements in muscle quality indices and functional performance of older men when exercises performed with BFR.",2020,A significant decrease in serum C-terminal Agrin Fragment (CAF) levels were observed in FT and FTBFR groups (p ≤ 0.05).,"['Thirty men (67.7\u202f±\u202f5.8 years', 'older adults', 'older men']","['Functional training with blood occlusion', 'FTBFR group wore pneumatic cuffs', 'functional training with blood flow restriction (BFR', 'functional training (FT), functional training with blood flow restriction (FTBFR), and control (C']","['circulatory levels of N-terminal propeptide type III collagen (P3NP', 'dynamic strength, flexibility, static, and dynamic balance', 'serum C-terminal Agrin Fragment (CAF) levels', 'arterial occlusion pressure', 'muscle quality indices and functional performance', 'levels of CAF']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0009332', 'cui_str': 'Collagen type III'}, {'cui': 'C0072054', 'cui_str': 'procollagen Type III-N-terminal peptide'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C4077009', 'cui_str': 'C-terminal agrin fragment'}, {'cui': 'C0264995', 'cui_str': 'Occlusion of artery'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.0143913,A significant decrease in serum C-terminal Agrin Fragment (CAF) levels were observed in FT and FTBFR groups (p ≤ 0.05).,"[{'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Bigdeli', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Mohammad Hasan', 'Initials': 'MH', 'LastName': 'Dehghaniyan', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Sadegh', 'Initials': 'S', 'LastName': 'Amani-Shalamzari', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran. Electronic address: amani_sadegh@khu.ac.ir.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Rajabi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Gahreman', 'Affiliation': 'College of Health and Human Sciences, Charles Darwin University, Darwin, Northern Territory, Australia.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104110']
3226,32473563,Exercise improves neurotrophins in multiple sclerosis independent of disability status.,"BACKGROUND


To date, studies examining the effect of exercise on neurotrophic factors in MS are contradictory, and this may be explained, in part, by moderators such as disability status. To investigating the effect of a 12-week (3sessions/week) supervised multimodal exercise program on neurotrophic factors levels.
METHODS


Ninety four women with MS were randomly assigned into exercise or control conditions with randomization stratified by Expanded Disability Status Scale (EDSS) scores of low (EDSS< 4.5), moderate (4.5 ≤EDSS≤ 6), or high (EDSS≥ 6.5) disability. The exercise program comprised resistance, endurance, Pilates, balance and stretch exercises. Resting level of neurotrophic factors, aerobic capacity, one-repetition maximum, and physiological cost index (PCI) were evaluated before and after the intervention period.
RESULTS


Exercise training improved brain-derived neurotrophic factor (BDNF), neurotrophin (NT)-3, and NT-4/5 levels. The effect of exercise on NT-3 was dependent on disability status such that exercise groups with low and high disability had more pronounced changes compared with other condition. There were no exercise effects on ciliary neurotrophic factor (CNTF) and glial cell-derived neurotrophic factor (GDNF). Aerobic capacity and one-repetition maximum, but not PCI, were improved with exercise independent of disability status.
CONCLUSIONS


Exercise can stimulate neurotrophic production and secretion, and this is generally not influenced by disability status. Exercise training may be an adjuvant for disease-modifying therapy among people with MS, and its effect may not be moderated by disability status.",2020,There were no exercise effects on ciliary neurotrophic factor (CNTF) and glial cell-derived neurotrophic factor (GDNF).,['Ninety four women with MS'],"['Exercise', 'Exercise training', 'multimodal exercise program', 'exercise program comprised resistance, endurance, Pilates, balance and stretch exercises']","['Resting level of neurotrophic factors, aerobic capacity, one-repetition maximum, and physiological cost index (PCI', 'ciliary neurotrophic factor (CNTF) and glial cell-derived neurotrophic factor (GDNF', 'brain-derived neurotrophic factor (BDNF), neurotrophin (NT)-3, and NT-4/5 levels', 'Disability Status Scale (EDSS) scores', 'Aerobic capacity and one-repetition maximum']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027754', 'cui_str': 'Nerve growth factor'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0207071', 'cui_str': 'Ciliary Neuronotrophic Factor'}, {'cui': 'C0027836', 'cui_str': 'Glia'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0083735', 'cui_str': 'Neurotrophin 3'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",94.0,0.0199456,There were no exercise effects on ciliary neurotrophic factor (CNTF) and glial cell-derived neurotrophic factor (GDNF).,"[{'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Banitalebi', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran. Electronic address: banitalebi@sku.ac.ir.'}, {'ForeName': 'Majid Mardaniyan', 'Initials': 'MM', 'LastName': 'Ghahfarrokhi', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran.'}, {'ForeName': 'Raoof', 'Initials': 'R', 'LastName': 'Negaresh', 'Affiliation': 'Department of Physical Education & Sport Sciences, Faculty of Humanities, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Abdolreza', 'Initials': 'A', 'LastName': 'Kazemi', 'Affiliation': 'Department of Sport Sciences, Vali-E-Asr University of Rafsanjan, Rafsanjan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Faramarzi', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Motl', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Zimmer', 'Affiliation': 'Department for Performance and Health, Institute for Sport and Sport Science, Technical University Dortmund, Germany.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102143']
3227,32478802,Comparative Effectiveness of Carotid Endarterectomy vs Initial Medical Therapy in Patients With Asymptomatic Carotid Stenosis.,"Importance


Carotid endarterectomy (CEA) among asymptomatic patients involves a trade-off between a higher short-term perioperative risk in exchange for a lower long-term risk of stroke. The clinical benefit observed in randomized clinical trials (RCTs) may not extend to real-world practice.
Objective


To examine whether early intervention (CEA) was superior to initial medical therapy in real-world practice in preventing fatal and nonfatal strokes among patients with asymptomatic carotid stenosis.
Design, Setting, and Participants


This comparative effectiveness study was conducted from August 28, 2018, to March 2, 2020, using the Corporate Data Warehouse, Suicide Data Repository, and other databases of the US Department of Veterans Affairs. Data analyzed were those of veterans of the US Armed Forces aged 65 years or older who received carotid imaging between January 1, 2005, and December 31, 2009. Patients without a carotid imaging report, those with carotid stenosis of less than 50% or hemodynamically insignificant stenosis, and those with a history of stroke or transient ischemic attack in the 6 months before index imaging were excluded. A cohort of patients who received initial medical therapy and a cohort of similar patients who received CEA were constructed and followed up for 5 years. The target trial method was used to compute weighted Kaplan-Meier curves and estimate the risk of fatal and nonfatal strokes in each cohort in the pragmatic sample across 5 years of follow-up. This analysis was repeated after restricting the sample to patients who met RCT inclusion criteria. Cumulative incidence functions for fatal and nonfatal strokes were estimated, accounting for nonstroke deaths as competing risks in both the pragmatic and RCT-like samples.
Exposures


Receipt of CEA vs initial medical therapy.
Main Outcomes and Measures


Fatal and nonfatal strokes.
Results


Of the total 5221 patients, 2712 (51.9%; mean [SD] age, 73.6 [6.0] years; 2678 men [98.8%]) received CEA and 2509 (48.1%; mean [SD] age, 73.6 [6.0] years; 2479 men [98.8%]) received initial medical therapy within 1 year after the index carotid imaging. The observed rate of stroke or death (perioperative complications) within 30 days in the CEA cohort was 2.5% (95% CI, 2.0%-3.1%). The 5-year risk of fatal and nonfatal strokes was lower among patients randomized to CEA compared with patients randomized to initial medical therapy (5.6% vs 7.8%; risk difference, -2.3%; 95% CI, -4.0% to -0.3%). In an analysis that incorporated the competing risk of death, the risk difference between the 2 cohorts was lower and not statistically significant (risk difference, -0.8%; 95% CI, -2.1% to 0.5%). Among patients who met RCT inclusion criteria, the 5-year risk of fatal and nonfatal strokes was 5.5% (95% CI, 4.5%-6.5%) among patients randomized to CEA and was 7.6% (95% CI, 5.7%-9.5%) among those randomized to initial medical therapy (risk difference, -2.1%; 95% CI, -4.4% to -0.2%). Accounting for competing risks resulted in a risk difference of -0.9% (95% CI, -2.9% to 0.7%) that was not statistically significant.
Conclusions and Relevance


This study found that the absolute reduction in the risk of fatal and nonfatal strokes associated with early CEA was less than half the risk difference in trials from 20 years ago and was no longer statistically significant when the competing risk of nonstroke deaths was accounted for in the analysis. Given the nonnegligible perioperative 30-day risks and the improvements in stroke prevention, medical therapy may be an acceptable therapeutic strategy.",2020,"The 5-year risk of fatal and nonfatal strokes was lower among patients randomized to CEA compared with patients randomized to initial medical therapy (5.6% vs 7.8%; risk difference, -2.3%; 95% CI, -4.0% to -0.3%).","['asymptomatic patients', 'Patients With Asymptomatic Carotid Stenosis', 'total 5221 patients, 2712 (51.9%; mean [SD] age, 73.6 [6.0] years; 2678 men [98.8%]) received CEA and 2509 (48.1%; mean [SD] age, 73.6 [6.0] years; 2479 men [98.8%]) received', 'August 28, 2018, to March 2, 2020, using the Corporate Data Warehouse, Suicide Data Repository, and other databases of the US Department of Veterans Affairs', 'veterans of the US Armed Forces aged 65 years or older who received carotid imaging between January 1, 2005, and December 31, 2009', 'patients with asymptomatic carotid stenosis']","['CEA', 'initial medical therapy', 'Carotid endarterectomy (CEA', 'CEA vs initial medical therapy', 'Carotid Endarterectomy vs Initial Medical Therapy', 'early intervention (CEA']","['rate of stroke or death (perioperative complications', 'history of stroke or transient ischemic attack', 'nonstroke deaths', 'risk of fatal and nonfatal strokes', 'fatal and nonfatal strokes', '5-year risk of fatal and nonfatal strokes', 'Cumulative incidence functions for fatal and nonfatal strokes', 'Measures\n\n\nFatal and nonfatal strokes']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007282', 'cui_str': 'Carotid artery stenosis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0014099', 'cui_str': 'Carotid endarterectomy'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4505078', 'cui_str': 'Data Warehouse'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0203382', 'cui_str': 'Imaging of carotid arteries'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0014099', 'cui_str': 'Carotid endarterectomy'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",5221.0,0.184697,"The 5-year risk of fatal and nonfatal strokes was lower among patients randomized to CEA compared with patients randomized to initial medical therapy (5.6% vs 7.8%; risk difference, -2.3%; 95% CI, -4.0% to -0.3%).","[{'ForeName': 'Salomeh', 'Initials': 'S', 'LastName': 'Keyhani', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of California San Francisco, San Francisco.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Cheng', 'Affiliation': 'Department of Neurology, UCLA (University of California Los Angeles), Los Angeles.'}, {'ForeName': 'Katherine J', 'Initials': 'KJ', 'LastName': 'Hoggatt', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of California San Francisco, San Francisco.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Austin', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Madden', 'Affiliation': 'Northern California Institute of Research and Education, San Francisco.'}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Hebert', 'Affiliation': 'University of Washington, Seattle.'}, {'ForeName': 'Ethan A', 'Initials': 'EA', 'LastName': 'Halm', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Naseri', 'Affiliation': 'San Francisco Veterans Affairs (VA) Medical Center, San Francisco, California.'}, {'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Johanning', 'Affiliation': 'Department of Surgery, University of Nebraska, Omaha.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Mowery', 'Affiliation': 'Biomedical Informatics, University of Utah, Salt Lake City.'}, {'ForeName': 'Wendy W', 'Initials': 'WW', 'LastName': 'Chapman', 'Affiliation': 'University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Bravata', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis.'}]",JAMA neurology,['10.1001/jamaneurol.2020.1427']
3228,32478849,Effects of In-Person Navigation to Address Family Social Needs on Child Health Care Utilization: A Randomized Clinical Trial.,"Importance


While many organizations endorse screening for social risk factors in clinical settings, few studies have examined the health and utilization effects of interventions to address social needs.
Objective


To compare the acute care utilization effects of a written resources handout vs an in-person navigation service intervention to address social needs.
Design, Settings, and Participants


In this secondary analysis of a randomized clinical trial, 1809 adult caregivers of pediatric patients seen in primary and urgent care clinics of 2 safety-net hospitals in northern California were recruited between October 13, 2013, and August 27, 2015. Each participating family was randomly assigned to an in-person navigator intervention vs active control to address the family's social needs. Analyses were conducted between February 28, 2018, and September 25, 2019.
Interventions


Caregivers either received written information about relevant local resources related to social needs (active control) or met with a patient navigator focused on helping them resolve social needs (navigator intervention). After an initial in-person visit, navigation services included telephone, email, and/or in-person follow-up for up to 3 months.
Main Outcome and Measures


Child emergency department visit or hospitalization within 12 months of study enrollment.
Results


Among the 1300 caregivers enrolled in the study without missing follow-up data, most spoke English (878 [67.5%]) and were women (1127 [86.7%]), with a mean (SD) age of 33.0 (9.33) years. Most children were aged 0 to 5 years (779 of 1300 [59.9%]), 723 children (55.6%) had Hispanic ethnicity, and 462 children (35.5%) were in excellent health; 840 families (64.6%) were recruited from urgent care. In total, 637 families (49.0%) were randomized to the in-person navigator group and 663 (51.0%) to the active control group. There was no difference in risk of an emergency department visit between the 2 groups. Children enrolled in the in-person navigator group had a decreased risk of hospitalization within 12 months (hazard ratio, 0.59; 05% CI, 0.38-0.94; P = .03), making them 69% less likely to be hospitalized.
Conclusions and Relevance


In this randomized clinical trial evaluating heath care utilization effects of programs designed to address social needs among families, children enrolled in the navigation group were significantly less likely to be hospitalized after the intervention but equally likely to have an emergency department visit. These findings strengthen our understanding of the effects of addressing social needs in clinical settings as part of a comprehensive strategy to improve health and reduce health care utilization.
Trial Registration


ClinicalTrials.gov Identifier: NCT01939704.",2020,"Children enrolled in the in-person navigator group had a decreased risk of hospitalization within 12 months (hazard ratio, 0.59; 05% CI, 0.38-0.94; P = .03), making them 69% less likely to be hospitalized.
","['1300 caregivers enrolled in the study without missing follow-up data, most spoke English (878 [67.5%]) and were women (1127 [86.7%]), with a mean (SD) age of 33.0 (9.33) years', 'In total, 637 families (49.0', '1809 adult caregivers of pediatric patients seen in primary and urgent care clinics of 2 safety-net hospitals in northern California were recruited between October 13, 2013, and August 27, 2015', 'Most children were aged 0 to 5 years (779 of 1300 [59.9%]), 723 children (55.6%) had Hispanic ethnicity, and 462 children (35.5%) were in excellent health; 840 families (64.6%) were recruited from urgent care', 'Child Health Care Utilization']","['written information about relevant local resources related to social needs (active control) or met with a patient navigator focused on helping them resolve social needs (navigator intervention', 'written resources handout vs an in-person navigation service intervention', ""person navigator intervention vs active control to address the family's social needs"", 'Person Navigation']","['Measures\n\n\nChild emergency department visit or hospitalization within 12 months of study enrollment', 'risk of an emergency department visit', 'risk of hospitalization']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1551285', 'cui_str': 'Urgent care clinic'}, {'cui': 'C3661443', 'cui_str': 'Safety-net Hospitals'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517866', 'cui_str': '723'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C2362545', 'cui_str': 'Urgent Care'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1709488', 'cui_str': 'Patient navigator'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",1809.0,0.114442,"Children enrolled in the in-person navigator group had a decreased risk of hospitalization within 12 months (hazard ratio, 0.59; 05% CI, 0.38-0.94; P = .03), making them 69% less likely to be hospitalized.
","[{'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Pantell', 'Affiliation': 'Department of Pediatrics, University of California, San Francisco.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Hessler', 'Affiliation': 'Department of Family and Community Medicine, University of California, San Francisco.'}, {'ForeName': 'Dayna', 'Initials': 'D', 'LastName': 'Long', 'Affiliation': ""Center for Child and Community Health, UCSF Benioff Children's Hospital Oakland, Oakland, California.""}, {'ForeName': 'Maoya', 'Initials': 'M', 'LastName': 'Alqassari', 'Affiliation': ""UCSF Benioff Children's Hospital Oakland, Oakland, California.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Schudel', 'Affiliation': ""UCSF Benioff Children's Hospital Oakland, Oakland, California.""}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Laves', 'Affiliation': 'Department of Pediatrics, University of California, San Francisco.'}, {'ForeName': 'Denisse E', 'Initials': 'DE', 'LastName': 'Velazquez', 'Affiliation': 'Social Interventions Research and Evaluation Network, Department of Family and Community Medicine, University of California, San Francisco.'}, {'ForeName': 'Anais', 'Initials': 'A', 'LastName': 'Amaya', 'Affiliation': 'Department of Family and Community Medicine, University of California, San Francisco.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Sweeney', 'Affiliation': 'School of Nursing, University of California, San Francisco.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Burns', 'Affiliation': ""Department of Obstetrics and Gynecology, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Francis L', 'Initials': 'FL', 'LastName': 'Harrison', 'Affiliation': 'School of Medicine, University of California, San Francisco.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Adler', 'Affiliation': 'Department of Pediatrics, University of California, San Francisco.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Gottlieb', 'Affiliation': 'Center for Health and Community, University of California, San Francisco.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.6445']
3229,32478913,"Cognitive and physical performance are well preserved following standard blood donation: A noninferiority, randomized clinical trial.","BACKGROUND


A walking blood bank (WBB) refers to the use of fellow combatants for battlefield blood donation. This requires pretesting combatants for infectious diseases and blood type. A fundamental prerequisite for this technique is that the donating soldier will suffer minimal physiological and mental impact. The purpose of the current study is to assess the effect of blood shedding on battlefield performance.
METHODS


This is a double-blind randomized control trial. Forty Israel Defense Forces combatants volunteered for the study. Participants underwent baseline evaluation, including repeated measurement of vital signs, cognitive evaluation, physical evaluation, and a strenuous shooting test. Three weeks after the baseline evaluation, subjects were randomized to either blood donation or the control group. For blinding purposes, all subjects underwent venous catheterization for the duration of a blood donation. Repeated vital signs and function evaluation were then performed.
RESULTS


Thirty-six patients were available for randomization. Baseline measurements were similar for both groups. Mean strenuous shooting score was 80.5 ± 9.5 for the control group and 82 ± 6.6 for the test group (p = 0.58). No clinically or statistically significant differences were found in tests designed to evaluate cognitive performance or physical functions. Vital signs taken multiple times were also similar between the test and control groups.
CONCLUSIONS


Executive, cognitive, and physical functions were well preserved after blood donation. This study supports the hypothesis that a WBB does not decrease donor combat performance. The categorical prohibition of physical exercise following blood donation might need to be reconsidered in both military and civilian populations.",2020,No clinically or statistically significant differences were found in tests designed to evaluate cognitive performance or physical functions.,"['Forty Israel Defense Forces combatants volunteered for the study', 'Thirty-six patients were available for randomization']",[],"['Vital signs taken multiple times', 'Executive, cognitive, and physical functions', 'Cognitive and physical performance', 'Mean strenuous shooting score', 'cognitive performance or physical functions']","[{'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]",[],"[{'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1444774', 'cui_str': 'Shooting sensation quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",40.0,0.0682259,No clinically or statistically significant differences were found in tests designed to evaluate cognitive performance or physical functions.,"[{'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Nadler', 'Affiliation': ""Surgeon General's Headquarters, Israel Defense Forces, Ramat Gan, Israel.""}, {'ForeName': 'Avishai M', 'Initials': 'AM', 'LastName': 'Tsur', 'Affiliation': ""Surgeon General's Headquarters, Israel Defense Forces, Ramat Gan, Israel.""}, {'ForeName': 'Ari M', 'Initials': 'AM', 'LastName': 'Lipsky', 'Affiliation': 'Department of Emergency Medicine, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Gadi', 'Initials': 'G', 'LastName': 'Lending', 'Affiliation': 'Bar-Ilan University Faculty of Medicine (G.E.), Safed, Israel.'}, {'ForeName': 'Avi', 'Initials': 'A', 'LastName': 'Benov', 'Affiliation': ""Surgeon General's Headquarters, Israel Defense Forces, Ramat Gan, Israel.""}, {'ForeName': 'Ishai', 'Initials': 'I', 'LastName': 'Ostffeld', 'Affiliation': 'Office of Medical Affairs, National Insurance Institute of Israel, Jerusalem, Israel.'}, {'ForeName': 'Eilat', 'Initials': 'E', 'LastName': 'Shinar', 'Affiliation': 'National Blood Services, Magen David Adom, Ramat Gan, Israel.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Yanovich', 'Affiliation': ""Surgeon General's Headquarters, Israel Defense Forces, Ramat Gan, Israel.""}, {'ForeName': 'Asher', 'Initials': 'A', 'LastName': 'Moser', 'Affiliation': 'National Blood Services, Magen David Adom, Ramat Gan, Israel.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Levy', 'Affiliation': ""Surgeon General's Headquarters, Israel Defense Forces, Ramat Gan, Israel.""}, {'ForeName': 'Nikolai', 'Initials': 'N', 'LastName': 'Haiman', 'Affiliation': ""Surgeon General's Headquarters, Israel Defense Forces, Ramat Gan, Israel.""}, {'ForeName': 'Hakon', 'Initials': 'H', 'LastName': 'Eliassen', 'Affiliation': 'Faculty of Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Tarif', 'Initials': 'T', 'LastName': 'Bader', 'Affiliation': ""Surgeon General's Headquarters, Israel Defense Forces, Ramat Gan, Israel.""}, {'ForeName': 'Elon', 'Initials': 'E', 'LastName': 'Glassberg', 'Affiliation': ""Surgeon General's Headquarters, Israel Defense Forces, Ramat Gan, Israel.""}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Surgeon General's Headquarters, Israel Defense Forces, Ramat Gan, Israel.""}]",Transfusion,['10.1111/trf.15624']
3230,32476162,"Eflapegrastim, a Long-Acting Granulocyte-Colony Stimulating Factor for the Management of Chemotherapy-Induced Neutropenia: Results of a Phase III Trial.","BACKGROUND


Eflapegrastim, a novel, long-acting recombinant human granulocyte-colony stimulating factor (rhG-CSF), consists of a rhG-CSF analog conjugated to a human IgG4 Fc fragment via a short polyethylene glycol linker. Preclinical and phase I and II pharmacodynamic and pharmacokinetic data showed increased potency for neutrophil counts for eflapegrastim versus pegfilgrastim. This open-label phase III trial compared the efficacy and safety of eflapegrastim with pegfilgrastim for reducing the risk of chemotherapy-induced neutropenia.
MATERIALS AND METHODS


Patients with early-stage breast cancer were randomized 1:1 to fixed-dose eflapegrastim 13.2 mg (3.6 mg G-CSF) or standard pegfilgrastim (6 mg G-CSF) following standard docetaxel plus cyclophosphamide chemotherapy for 4 cycles. The primary objective was to demonstrate the noninferiority of eflapegrastim compared with pegfilgrastim in mean duration of severe neutropenia (DSN; grade 4) in cycle 1.
RESULTS


Eligible patients were randomized 1:1 to study arms (eflapegrastim, n = 196; pegfilgrastim, n = 210). The incidence of cycle 1 severe neutropenia was 16% (n = 31) for eflapegrastim versus 24% (n = 51) for pegfilgrastim, reducing the relative risk by 35% (p = .034). The difference in mean cycle 1 DSN (-0.148 day) met the primary endpoint of noninferiority (p < .0001) and also showed statistical superiority for eflapegrastim (p = .013). Noninferiority was maintained for the duration of treatment (all cycles, p < .0001), and secondary efficacy endpoints and safety results were also comparable for study arms.
CONCLUSION


These results demonstrate noninferiority and comparable safety for eflapegrastim at a lower G-CSF dose versus pegfilgrastim. The potential for increased potency of eflapegrastim to deliver improved clinical benefit warrants further clinical study in patients at higher risk for CIN.
IMPLICATIONS FOR PRACTICE


Chemotherapy-induced neutropenia (CIN) remains a significant clinical dilemma for oncology patients who are striving to complete their prescribed chemotherapy regimen. In a randomized, phase III trial comparing eflapegrastim to pegfilgrastim in the prevention of CIN, the efficacy of eflapegrastim was noninferior to pegfilgrastim and had comparable safety. Nevertheless, the risk of CIN remains a great concern for patients undergoing chemotherapy, as the condition frequently results in chemotherapy delays, dose reductions, and treatment discontinuations.",2020,"Noninferiority was maintained for the duration of treatment (all cycles, p < .0001), and secondary efficacy endpoints and safety results were also comparable for study arms.
","['patients at higher risk for CIN', 'oncology patients who are striving to complete their prescribed chemotherapy regimen', 'Patients with early-stage breast cancer', 'Eligible patients']","['pegfilgrastim', 'eflapegrastim 13.2 mg (3.6 mg G-CSF) or standard pegfilgrastim', 'eflapegrastim with pegfilgrastim', 'standard docetaxel plus cyclophosphamide chemotherapy']","['mean cycle 1 DSN', 'incidence of cycle 1 severe neutropenia', 'neutrophil counts']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1827687', 'cui_str': 'Chemotherapy-induced neutropenia'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}]",,0.0418564,"Noninferiority was maintained for the duration of treatment (all cycles, p < .0001), and secondary efficacy endpoints and safety results were also comparable for study arms.
","[{'ForeName': 'Lee S', 'Initials': 'LS', 'LastName': 'Schwartzberg', 'Affiliation': 'West Cancer Center, Germantown, Tennessee, USA.'}, {'ForeName': 'Gajanan', 'Initials': 'G', 'LastName': 'Bhat', 'Affiliation': 'Spectrum Pharmaceuticals, Inc., Irvine, California, USA.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Peguero', 'Affiliation': 'Oncology Consultants PA, Houston, Texas, USA.'}, {'ForeName': 'Richy', 'Initials': 'R', 'LastName': 'Agajanian', 'Affiliation': 'The Oncology Institute of Hope and Innovation, Downey, California, USA.'}, {'ForeName': 'Jayaram S', 'Initials': 'JS', 'LastName': 'Bharadwaj', 'Affiliation': 'Pacific Cancer Medical Center, Anaheim, California, USA.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Restrepo', 'Affiliation': 'Texas Oncology PA, McAllen, Texas, USA.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Hlalah', 'Affiliation': 'Bond Clinic PA, Winter Haven, Florida, USA.'}, {'ForeName': 'Inderjit', 'Initials': 'I', 'LastName': 'Mehmi', 'Affiliation': 'City of Hope Comprehensive Cancer Center, Simi Valley, California, USA.'}, {'ForeName': 'Shanta', 'Initials': 'S', 'LastName': 'Chawla', 'Affiliation': 'Spectrum Pharmaceuticals, Inc., Irvine, California, USA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Hasal', 'Affiliation': 'Spectrum Pharmaceuticals, Inc., Irvine, California, USA.'}, {'ForeName': 'Zane', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Spectrum Pharmaceuticals, Inc., Irvine, California, USA.'}, {'ForeName': 'Patrick Wayne', 'Initials': 'PW', 'LastName': 'Cobb', 'Affiliation': 'St. Vincent Frontier Cancer Center, Billings, Montana, USA.'}]",The oncologist,['10.1634/theoncologist.2020-0105']
3231,32484533,Effect of a Patient-Centered Decision Support Tool on Rates of Trial of Labor After Previous Cesarean Delivery: The PROCEED Randomized Clinical Trial.,"Importance


Reducing cesarean delivery rates in the US is an important public health goal; despite evidence of the safety of vaginal birth after cesarean delivery, most women have scheduled repeat cesarean deliveries. A decision support tool could help increase trial-of-labor rates.
Objective


To analyze the effect of a patient-centered decision support tool on rates of trial of labor and vaginal birth after cesarean delivery and decision quality.
Design, Setting, and Participants


Multicenter, randomized, parallel-group clinical trial conducted in Boston, Chicago, and the San Francisco Bay area. A total of 1485 English- or Spanish-speaking women with 1 prior cesarean delivery and no contraindication to trial of labor were enrolled between January 2016 and January 2019; follow-up was completed in June 2019.
Interventions


Participants were randomized to use a tablet-based decision support tool prior to 25 weeks' gestation (n=742) or to receive usual care (without the tool) (n=743).
Main Outcomes and Measures


The primary outcome was trial of labor; vaginal birth was the main secondary outcome. Other secondary outcomes focused on maternal and neonatal outcomes and decision quality.
Results


Among 1485 patients (mean age, 34.0 [SD, 4.5] years), 1470 (99.0%) completed the trial (n = 735 in both randomization groups) and were included in the analysis. Trial-of-labor rates did not differ significantly between intervention and control groups (43.3% vs 46.2%, respectively; adjusted absolute risk difference, -2.78% [95% CI, -7.80% to 2.25%]; adjusted relative risk, 0.94 [95% CI, 0.84-1.05]). There were no statistically significant differences in vaginal birth rates (31.8% in both groups; adjusted absolute risk difference, -0.04% [95% CI, -4.80% to 4.71%]; adjusted relative risk, 1.00 [95% CI, 0.86-1.16]) or in any of the other 6 clinical maternal and neonatal secondary outcomes. There also were no significant differences between the intervention and control groups in the 5 decision quality measures (eg, mean decisional conflict scores were 17.2 and 17.5, respectively; adjusted mean difference, -0.38 [95% CI, -1.81 to 1.05]; scores >25 are considered clinically important).
Conclusions and Relevance


Among women with 1 previous cesarean delivery, use of a decision support tool compared with usual care did not significantly change the rate of trial of labor. Further research may be needed to assess the efficacy of this tool in other clinical settings or when implemented at other times in pregnancy.",2020,"There also were no significant differences between the intervention and control groups in the 5 decision quality measures (eg, mean decisional conflict scores were 17.2 and 17.5, respectively; adjusted mean difference, -0.38","['1485 patients (mean age, 34.0 [SD, 4.5] years), 1470 (99.0%) completed the trial (n\u2009=\u2009735 in both randomization groups) and were included in the analysis', 'women with 1 previous cesarean delivery', 'A total of 1485 English- or Spanish-speaking women with 1 prior cesarean delivery and no contraindication to trial of labor were enrolled between January 2016 and January 2019; follow-up was completed in June 2019']","[""tablet-based decision support tool prior to 25 weeks' gestation (n=742) or to receive usual care (without the tool"", 'patient-centered decision support tool', 'Patient-Centered Decision Support Tool']","['labor; vaginal birth', 'labor rates', 'cesarean delivery rates', '5 decision quality measures (eg, mean decisional conflict scores', 'Rates of Trial of Labor', 'rate of trial of labor', 'rates of trial of labor and vaginal birth', 'vaginal birth rates', 'maternal and neonatal outcomes and decision quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0040862', 'cui_str': 'Trial labor'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0870393', 'cui_str': 'Decision support tool'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040862', 'cui_str': 'Trial labor'}, {'cui': 'C0005608', 'cui_str': 'Birth Rate'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.215832,"There also were no significant differences between the intervention and control groups in the 5 decision quality measures (eg, mean decisional conflict scores were 17.2 and 17.5, respectively; adjusted mean difference, -0.38","[{'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Kuppermann', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco.'}, {'ForeName': 'Anjali J', 'Initials': 'AJ', 'LastName': 'Kaimal', 'Affiliation': 'Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Cinthia', 'Initials': 'C', 'LastName': 'Blat', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco.'}, {'ForeName': 'Mari-Paule', 'Initials': 'MP', 'LastName': 'Thiet', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco.'}, {'ForeName': 'Yamilee', 'Initials': 'Y', 'LastName': 'Bermingham', 'Affiliation': 'Marin Community Clinic, San Rafael, California.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Altshuler', 'Affiliation': 'California Pacific Medical Center, San Francisco.'}, {'ForeName': 'Allison S', 'Initials': 'AS', 'LastName': 'Bryant', 'Affiliation': 'Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bacchetti', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Grobman', 'Affiliation': 'Feinberg School of Medicine, Department of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois.'}]",JAMA,['10.1001/jama.2020.5952']
3232,32473275,Exploring the Effects of an Acute Dose of Antipsychotic Medication on Motivation-mediated BOLD Activity Using fMRI and a Perceptual Decision-making Task.,"The left inferior frontal gyrus and the bilateral ventral striatum are thought to be involved in motivation-mediated decision-making. Antipsychotics may influence this relationship, and atypical antipsychotics improve secondary negative symptoms in schizophrenia, such as loss of motivation, although the acute effects of pharmacological medication on motivation are not fully understood. In this single-blinded, randomized controlled trial, 49 healthy volunteers were randomized into three groups to receive a single dose of haloperidol, aripiprazole or placebo. Between 4.0 and 5.6 h later, participant's brain blood-oxygen-level dependent (BOLD) activity was recorded using functional magnetic resonance imaging (fMRI) while completing a perceptual decision-making fMRI task consisting of one neutral and one motivated condition. Response bias, reflecting the participant's willingness to say that the target stimulus is present, was calculated using signal detection theory. Concurrent with widespread changes in BOLD signal in the motivated vs. neutral condition, a less conservative, mathematically optimal response bias was observed in the motivated condition across the whole sample. Within-group differences in BOLD signal in the left inferior frontal gyrus and bilateral ventral striatum were observed between conditions in the aripiprazole and haloperidol groups, but not in the placebo group. No robust between-group differences in brain activity in the left inferior frontal gyrus or the bilateral ventral striatum were found. Overall, we found no robust evidence for an effect of either aripiprazole or haloperidol on motivationally mediated behavior. An interesting pattern of correlations possibly related to pharmacologically induced alterations in the dopamine system was observed, although findings remain inconclusive and must be replicated in larger samples.",2020,"Overall, we found no robust evidence for an effect of either aripiprazole or haloperidol on motivationally mediated behavior.",['49 healthy volunteers'],"['haloperidol, aripiprazole or placebo', 'haloperidol', 'Antipsychotics', 'aripiprazole', 'antipsychotic medication', 'placebo']","['BOLD signal', 'brain blood-oxygen-level dependent (BOLD) activity', 'brain activity', 'bilateral ventral striatum']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0750950', 'cui_str': 'Ventral Striatum'}]",49.0,0.0560753,"Overall, we found no robust evidence for an effect of either aripiprazole or haloperidol on motivationally mediated behavior.","[{'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Delfin', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital, Norway; Centre for Ethics, Law and Mental Health, Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Sweden; Research Department, Regional Forensic Psychiatric Clinic Växjö, Sweden. Electronic address: carl.delfin@gu.se.'}, {'ForeName': 'Greg E', 'Initials': 'GE', 'LastName': 'Reckless', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital, Norway; Institute of Clinical Medicine, University of Oslo, Norway.'}, {'ForeName': 'Ingeborg', 'Initials': 'I', 'LastName': 'Bolstad', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital, Norway; Institute of Clinical Medicine, University of Oslo, Norway.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Groote', 'Affiliation': 'Computational Radiology & Artificial Intelligence, Division of Radiology and Nuclear Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ole A', 'Initials': 'OA', 'LastName': 'Andreassen', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital, Norway; Institute of Clinical Medicine, University of Oslo, Norway.'}, {'ForeName': 'Jimmy', 'Initials': 'J', 'LastName': 'Jensen', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital, Norway; Centre for Psychology, Kristianstad University, Kristianstad, Sweden.'}]",Neuroscience,['10.1016/j.neuroscience.2020.05.035']
3233,32473355,TicagRelor Or Clopidogrel in severe or terminal chronic kidney patients Undergoing PERcutaneous coronary intervention for acute coronary syndrome: The TROUPER trial.,"Chronic kidney disease (CKD) is associated with an increased risk of acute coronary syndrome (ACS) and cardiovascular death. CKD patients suffering from ACS are exposed to an increased risk of thrombotic recurrences and a higher bleeding rate than patients with normal renal function. However, CKD patients are excluded or underrepresented in clinical trials. Therefore, determining the optimal antiplatelet strategy in this population is of utmost importance. We designed the TicagRelor Or Clopidogrel in severe or terminal chronic kidney patients Undergoing PERcutaneous coronary intervention for acute coronary syndrome (TROUPER) trial: a prospective, controlled, multicenter, randomized trial to investigate the optimal P2Y12 antagonist in CKD patients with ACS. Patients with stage ≥3b CKD are eligible if the diagnosis of ACS is made and invasive strategy scheduled. Patients are randomized 1:1 between a control group with a 600-mg loading dose of clopidogrel followed by a 75-mg/d maintenance dose for 1 year and an experimental group with a 180-mg loading dose of ticagrelor followed by a 90-mg twice daily maintenance dose for the same duration. The primary end point is defined by the rate of major adverse cardiovascular events, including death, myocardial infarction, urgent revascularization, and stroke at 1 year. Safety will be evaluated by the bleeding rate (Bleeding Academic Research Consortium). To demonstrate the superiority of ticagrelor on major adverse cardiovascular events, we calculated that 508 patients are required. The aim of the TROUPER trial is to compare the efficacy of ticagrelor and clopidogrel in stage >3b CKD patients presenting with ACS and scheduled for an invasive strategy. RCT# NCT03357874.",2020,"The primary end point is defined by the rate of major adverse cardiovascular events, including death, myocardial infarction, urgent revascularization, and stroke at 1 year.","['508 patients are required', 'CKD patients with ACS', 'CKD patients suffering from ACS', 'Patients with stage ≥3b', 'severe or terminal chronic kidney patients Undergoing', 'Chronic kidney disease (CKD', 'severe or terminal chronic kidney patients Undergoing PERcutaneous coronary intervention for acute coronary syndrome', 'stage >3b CKD patients presenting with ACS and scheduled for an invasive strategy']","['ticagrelor and clopidogrel', 'PERcutaneous coronary intervention', 'clopidogrel', 'TicagRelor Or Clopidogrel', 'ticagrelor']","['risk of thrombotic recurrences', 'rate of major adverse cardiovascular events, including death, myocardial infarction, urgent revascularization, and stroke at 1 year', 'bleeding rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",,0.0495371,"The primary end point is defined by the rate of major adverse cardiovascular events, including death, myocardial infarction, urgent revascularization, and stroke at 1 year.","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Laine', 'Affiliation': 'Aix-Marseille Univ, Intensive cardiac care unit, Assistance Publique-Hôpitaux de Marseille, Hôpital Nord, Marseille, France; Mediterranean Association for Research and Studies in Cardiology (MARS Cardio), Marseille, France; Aix Marseille Univ, INSERM, INRA, C2VN, Marseille, France. Electronic address: marc.laine@ap-hm.fr.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Lemesle', 'Affiliation': ""Institut Cœur et Poumon, CHRU de Lille, Faculté de Médecine de l'Université de Lille, Unité INSERM UMR 1011, Lille, France.""}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Burtey', 'Affiliation': 'Aix Marseille Univ, INSERM, INRA, C2VN, Marseille, France; Service de Néphrologie, Hôpital de la Conception, Assistance Publique des Hôpitaux de Marseille, Aix Marseille Université, Marseille, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Cayla', 'Affiliation': 'Département de Cardiologie, CHU Nîmes, Nîmes, France.'}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Range', 'Affiliation': 'Département de Cardiologie, CHU Chartres, Chartres, France.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Quaino', 'Affiliation': 'Service de Cardiologie, Centre Hospitalier Toulon, Toulon, France.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Canault', 'Affiliation': 'Aix Marseille Univ, INSERM, INRA, C2VN, Marseille, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Pankert', 'Affiliation': ""Service de Cardiologie, Centre Hospitalier d'Avignon, Avignon, France.""}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Paganelli', 'Affiliation': 'Aix-Marseille Univ, Intensive cardiac care unit, Assistance Publique-Hôpitaux de Marseille, Hôpital Nord, Marseille, France; Mediterranean Association for Research and Studies in Cardiology (MARS Cardio), Marseille, France.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Puymirat', 'Affiliation': 'Département de Cardiologie, Hôpital Européen Georges Pompidou, Assistance Publique des Hôpitaux de Paris, Université Paris Descartes, INSERM U-970, Paris, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bonello', 'Affiliation': 'Aix-Marseille Univ, Intensive cardiac care unit, Assistance Publique-Hôpitaux de Marseille, Hôpital Nord, Marseille, France; Mediterranean Association for Research and Studies in Cardiology (MARS Cardio), Marseille, France; Aix Marseille Univ, INSERM, INRA, C2VN, Marseille, France.'}]",American heart journal,['10.1016/j.ahj.2020.04.013']
3234,32475159,Randomized Pragmatic Trial of Stroke Transitional Care: The COMPASS Study.,"Background The objectives of this study were to develop and test in real-world clinical practice the effectiveness of a comprehensive postacute stroke transitional care (TC) management program. Methods and Results The COMPASS study (Comprehensive Post-Acute Stroke Services) was a pragmatic cluster-randomized trial where the hospital was the unit of randomization. The intervention (COMPASS-TC) was initiated at 20 hospitals, and 20 hospitals provided their usual care. Hospital staff enrolled 6024 adult stroke and transient ischemic attack patients discharged home between 2016 and 2018. COMPASS-TC was patient-centered and assessed social and functional determinates of health to inform individualized care plans. Ninety-day outcomes were evaluated by blinded telephone interviewers. The primary outcome was functional status (Stroke Impact Scale-16); secondary outcomes were mortality, disability, medication adherence, depression, cognition, self-rated health, fatigue, care satisfaction, home blood pressure monitoring, and falls. The primary analysis was intention to treat. Of intervention hospitals, 58% had uninterrupted intervention delivery. Thirty-five percent of patients at intervention hospitals attended a COMPASS clinic visit. The primary outcome was measured for 59% of patients and was not significantly influenced by the intervention. Mean Stroke Impact Scale-16 (±SD) was 80.6±21.1 in TC versus 79.9±21.4 in usual care. Home blood pressure monitoring was self-reported by 72% of intervention patients versus 64% of usual care patients (adjusted odds ratio, 1.43 [95% CI, 1.21-1.70]). No other secondary outcomes differed. Conclusions Although designed according to the best available evidence with input from various stakeholders and consistent with Centers for Medicare and Medicaid Services TC policies, the COMPASS model of TC was not consistently incorporated into real-world health care. We found no significant effect of the intervention on functional status at 90 days post-discharge. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02588664.",2020,"Home blood pressure monitoring was self-reported by 72% of intervention patients versus 64% of usual care patients (adjusted odds ratio, 1.43 [95% CI, 1.21-1.70]).","['Thirty-five percent of patients at intervention hospitals attended a COMPASS clinic visit', 'Hospital staff enrolled 6024 adult stroke and transient ischemic attack patients discharged home between 2016 and 2018']",['comprehensive postacute stroke transitional care (TC) management program'],"['Home blood pressure monitoring', 'functional status (Stroke Impact Scale-16); secondary outcomes were mortality, disability, medication adherence, depression, cognition, self-rated health, fatigue, care satisfaction, home blood pressure monitoring, and falls', 'Mean Stroke Impact Scale-16 (±SD', 'functional status']","[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0031228', 'cui_str': 'Hospital Personnel'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C4019071', 'cui_str': 'Transition Care'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1449681', 'cui_str': 'Home Blood Pressure Monitoring'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",6024.0,0.100697,"Home blood pressure monitoring was self-reported by 72% of intervention patients versus 64% of usual care patients (adjusted odds ratio, 1.43 [95% CI, 1.21-1.70]).","[{'ForeName': 'Pamela W', 'Initials': 'PW', 'LastName': 'Duncan', 'Affiliation': 'Department of Neurology (P.W.D., C.D.B., M.E.S., S.W.C., M.D.R.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Cheryl D', 'Initials': 'CD', 'LastName': 'Bushnell', 'Affiliation': 'Department of Neurology (P.W.D., C.D.B., M.E.S., S.W.C., M.D.R.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Sara B', 'Initials': 'SB', 'LastName': 'Jones', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health (S.B.J., A.M.J., A.M.K.-N., L.H.M., W.D.R.), University of North Carolina at Chapel Hill.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Psioda', 'Affiliation': 'Department of Biostatistics, Collaborative Studies Coordinating Center (M.A.P.), University of North Carolina at Chapel Hill.'}, {'ForeName': 'Sabina B', 'Initials': 'SB', 'LastName': 'Gesell', 'Affiliation': 'Social Sciences and Health Policy, Division of Public Health Sciences (S.B.G.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Ralph B', 'Initials': 'RB', 'LastName': ""D'Agostino"", 'Affiliation': 'Division of Public Health Sciences, Department of Biostatistics and Data Science (R.B.D., W.T.A.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Mysha E', 'Initials': 'ME', 'LastName': 'Sissine', 'Affiliation': 'Department of Neurology (P.W.D., C.D.B., M.E.S., S.W.C., M.D.R.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Sylvia W', 'Initials': 'SW', 'LastName': 'Coleman', 'Affiliation': 'Department of Neurology (P.W.D., C.D.B., M.E.S., S.W.C., M.D.R.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Johnson', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health (S.B.J., A.M.J., A.M.K.-N., L.H.M., W.D.R.), University of North Carolina at Chapel Hill.'}, {'ForeName': 'Blair F', 'Initials': 'BF', 'LastName': 'Barton-Percival', 'Affiliation': 'Area Agency on Aging, Piedmont Triad Regional Council, Kernersville, NC (B.F.B.-P., A.G.C.).'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Prvu-Bettger', 'Affiliation': 'Duke University School of Medicine, Durham, NC (J.P.-B., A.M.P.).'}, {'ForeName': 'Adrienne G', 'Initials': 'AG', 'LastName': 'Calhoun', 'Affiliation': 'Area Agency on Aging, Piedmont Triad Regional Council, Kernersville, NC (B.F.B.-P., A.G.C.).'}, {'ForeName': 'Doyle M', 'Initials': 'DM', 'LastName': 'Cummings', 'Affiliation': 'Brody School of Medicine, East Carolina University, Greenville, NC (D.M.C.).'}, {'ForeName': 'Janet K', 'Initials': 'JK', 'LastName': 'Freburger', 'Affiliation': 'Department of Physical Therapy School of Health and Rehabilitation Science, University of Pittsburgh, PA (J.K.F.).'}, {'ForeName': 'Jacqueline R', 'Initials': 'JR', 'LastName': 'Halladay', 'Affiliation': 'Department of Family Medicine, University of North Carolina School of Medicine, Chapel Hill (J.R.H.).'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Kucharska-Newton', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health (S.B.J., A.M.J., A.M.K.-N., L.H.M., W.D.R.), University of North Carolina at Chapel Hill.'}, {'ForeName': 'Gladys', 'Initials': 'G', 'LastName': 'Lundy-Lamm', 'Affiliation': 'Minority Women Health Alliance (TriStroke), Raleigh, NC (G.L.-L.).'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Lutz', 'Affiliation': 'University of North Carolina at Wilmington School of Nursing (B.J.L.).'}, {'ForeName': 'Laurie H', 'Initials': 'LH', 'LastName': 'Mettam', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health (S.B.J., A.M.J., A.M.K.-N., L.H.M., W.D.R.), University of North Carolina at Chapel Hill.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Pastva', 'Affiliation': 'Duke University School of Medicine, Durham, NC (J.P.-B., A.M.P.).'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Xenakis', 'Affiliation': 'Department of Biostatistics, Gillings School of Global Public Health (J.G.X.), University of North Carolina at Chapel Hill.'}, {'ForeName': 'Walter T', 'Initials': 'WT', 'LastName': 'Ambrosius', 'Affiliation': 'Division of Public Health Sciences, Department of Biostatistics and Data Science (R.B.D., W.T.A.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Meghan D', 'Initials': 'MD', 'LastName': 'Radman', 'Affiliation': 'Department of Neurology (P.W.D., C.D.B., M.E.S., S.W.C., M.D.R.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Betsy', 'Initials': 'B', 'LastName': 'Vetter', 'Affiliation': 'American Heart Association, Raleigh, NC (B.V.).'}, {'ForeName': 'Wayne D', 'Initials': 'WD', 'LastName': 'Rosamond', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health (S.B.J., A.M.J., A.M.K.-N., L.H.M., W.D.R.), University of North Carolina at Chapel Hill.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.119.006285']
3235,32484259,Repositioning for pressure injury prevention in adults.,"BACKGROUND


A pressure injury (PI), also referred to as a 'pressure ulcer', or 'bedsore', is an area of localised tissue damage caused by unrelieved pressure, friction, or shearing on any part of the body. Immobility is a major risk factor and manual repositioning a common prevention strategy. This is an update of a review first published in 2014.
OBJECTIVES


To assess the clinical and cost effectiveness of repositioning regimens(i.e. repositioning schedules and patient positions) on the prevention of PI in adults regardless of risk in any setting.
SEARCH METHODS


We searched the Cochrane Wounds Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, Ovid Embase, and EBSCO CINAHL Plus on 12 February 2019. We also searched clinical trials registries for ongoing and unpublished studies, and scanned the reference lists of included studies as well as reviews, meta-analyses, and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication, or study setting.
SELECTION CRITERIA


Randomised controlled trials (RCTs), including cluster-randomised trials (c-RCTs), published or unpublished, that assessed the effects of any repositioning schedule or different patient positions and measured PI incidence in adults in any setting.
DATA COLLECTION AND ANALYSIS


Three review authors independently performed study selection, 'Risk of bias' assessment, and data extraction. We assessed the certainty of the evidence using GRADE.
MAIN RESULTS


We identified five additional trials and one economic substudy in this update, resulting in the inclusion of a total of eight trials involving 3941 participants from acute and long-term care settings and two economic substudies in the review. Six studies reported the proportion of participants developing PI of any stage. Two of the eight trials reported within-trial cost evaluations. Follow-up periods were short (24 hours to 21 days). All studies were at high risk of bias. Funding sources were reported in five trials. Primary outcomes: proportion of new PI of any stage Repositioning frequencies: three trials compared different repositioning frequencies We pooled data from three trials (1074 participants) comparing 2-hourly with 4-hourly repositioning frequencies (fixed-effect; I² = 45%; pooled risk ratio (RR) 1.06, 95% confidence interval (CI) 0.80 to 1.41). It is uncertain whether 2-hourly repositioning compared with 4-hourly repositioning used in conjunction with any support surface increases or decreases the incidence of PI. The certainty of the evidence is very low due to high risk of bias, downgraded twice for risk of bias, and once for imprecision. One of these trials had three arms (967 participants) comparing 2-hourly, 3-hourly, and 4-hourly repositioning regimens on high-density mattresses; data for one comparison was included in the pooled analysis. Another comparison was based on 2-hourly versus 3-hourly repositioning. The RR for PI incidence was 4.06 (95% CI 0.87 to 18.98). The third study comparison was based on 3-hourly versus 4-hourly repositioning (RR 0.20, 95% CI 0.04 to 0.92). The certainty of the evidence is low due to risk of bias and imprecision. In one c-RCT, 262 participants in 32 ward clusters were randomised between 2-hourly and 3-hourly repositioning on standard mattresses and 4-hourly and 6-hourly repositioning on viscoelastic mattresses. The RR for PI with 2-hourly repositioning compared with 3-hourly repositioning on standard mattress is imprecise (RR 0.90, 95% CI 0.69 to 1.16; very low-certainty evidence). The CI for PI include both a large reduction and no difference for the comparison of 4-hourly and 6-hourly repositioning on viscoelastic foam (RR 0.73, 95% CI 0.53 to 1.02). The certainty of the evidence is very low, downgraded twice due to high risk of bias, and once for imprecision. Positioning regimens: four trials compared different tilt positions We pooled data from two trials (252 participants) that compared a 30° tilt with a 90° tilt (random-effects; I² = 69%). There was no clear difference in the incidence of stage 1 or 2 PI. The effect of tilt is uncertain because the certainty of evidence is very low (pooled RR 0.62, 95% CI 0.10 to 3.97), downgraded due to serious design limitations and very serious imprecision. One trial involving 120 participants compared 30° tilt and 45° tilt with 'usual care' and reported no occurrence of PI events (low certainty evidence). Another trial involving 116 ICU patients compared prone with the usual supine positioning for PI. Reporting was incomplete and this is low certainty evidence. Secondary outcomes No studies reported health-related quality of life utility scores, procedural pain, or patient satisfaction. Cost analysis Two included trials also performed economic analyses. A cost-minimisation analysis compared the costs of 3-hourly and 4-hourly repositioning with 2-hourly repositioning schedule amongst nursing home residents. The cost of repositioning was estimated at CAD 11.05 and CAD 16.74 less per resident per day for the 3-hourly or 4-hourly regimen, respectively, compared with the 2-hourly regimen. The estimates of economic benefit were driven mostly by the value of freed nursing time. The analysis assumed that 2-, 3-, or 4-hourly repositioning is associated with a similar incidence of PI, as no difference in incidence was observed. A second study compared the nursing time cost of 3-hourly repositioning using a 30° tilt with standard care (6-hourly repositioning with a 90° lateral rotation) amongst nursing home residents. The intervention was reported to be cost-saving compared with standard care (nursing time cost per patient EUR 206.60 versus EUR 253.10, incremental difference EUR -46.50, 95% CI EUR -1.25 to EUR -74.60).
AUTHORS' CONCLUSIONS


Despite the addition of five trials, the results of this update are consistent with our earlier review, with the evidence judged to be of low or very low certainty. There remains a lack of robust evaluations of repositioning frequency and positioning for PI prevention and uncertainty about their effectiveness. Since all comparisons were underpowered, there is a high level of uncertainty in the evidence base. Given the limited data from economic evaluations, it remains unclear whether repositioning every three hours using the 30° tilt versus ""usual care"" (90° tilt) or repositioning 3-to-4-hourly versus 2-hourly is less costly relative to nursing time.",2020,"The CI for PI include both a large reduction and no difference for the comparison of 4-hourly and 6-hourly repositioning on viscoelastic foam (RR 0.73, 95% CI 0.53 to 1.02).","[""120 participants compared 30° tilt and 45° tilt with 'usual care' and reported no occurrence of PI events (low certainty evidence"", '3941 participants from acute and long-term care settings and two economic substudies in the review', '262 participants in 32 ward clusters', 'adults', 'adults in any setting', 'nursing home residents', 'adults regardless of risk in any setting', 'two trials (252 participants) that compared a 30° tilt with a 90° tilt (random-effects; I² = 69', '116 ICU patients']","['2-hourly and 3-hourly repositioning on standard mattresses and 4-hourly and 6-hourly repositioning on viscoelastic mattresses', '3-hourly repositioning using a 30° tilt with standard care (6-hourly repositioning with a 90° lateral rotation', 'tilt positions']","['health-related quality of life utility scores, procedural pain, or patient satisfaction', 'cost of repositioning', 'Cost analysis', 'incidence of stage 1 or 2 PI', 'proportion of new PI of any stage Repositioning frequencies', 'cost-saving', 'RR for PI incidence', 'incidence of PI']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0332679', 'cui_str': 'Crushing injury'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0585322', 'cui_str': 'Every two hours'}, {'cui': 'C0585323', 'cui_str': 'Every three hours'}, {'cui': 'C0556030', 'cui_str': 'Repositioning'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0024940', 'cui_str': 'Mattress'}, {'cui': 'C0558292', 'cui_str': 'Hourly'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0733755', 'cui_str': 'Position'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1619712', 'cui_str': 'Procedural pain'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0556030', 'cui_str': 'Repositioning'}, {'cui': 'C0010171', 'cui_str': 'Analysis, Cost'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0332679', 'cui_str': 'Crushing injury'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0085550', 'cui_str': 'Cost Savings'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",116.0,0.24709,"The CI for PI include both a large reduction and no difference for the comparison of 4-hourly and 6-hourly repositioning on viscoelastic foam (RR 0.73, 95% CI 0.53 to 1.02).","[{'ForeName': 'Brigid M', 'Initials': 'BM', 'LastName': 'Gillespie', 'Affiliation': 'School of Nursing and Midwifery, Griffith University, Brisbane, Australia.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Walker', 'Affiliation': 'School of Nursing and Midwifery, Griffith University, Brisbane, Australia.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Latimer', 'Affiliation': 'School of Nursing and Midwifery, Griffith University, Brisbane, Australia.'}, {'ForeName': 'Lukman', 'Initials': 'L', 'LastName': 'Thalib', 'Affiliation': 'Department of Public Health, College of Health Sciences, QU Health, Qatar University, Doha, Qatar.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Whitty', 'Affiliation': 'Health Economics Group, Norwich Medical School, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'McInnes', 'Affiliation': ""Nursing Research Institute, St Vincent's Health Australia Sydney, St Vincent's Hospital Melbourne & Australian Catholic University, Fitzroy, Melbourne, Australia.""}, {'ForeName': 'Wendy P', 'Initials': 'WP', 'LastName': 'Chaboyer', 'Affiliation': 'School of Nursing and Midwifery, Griffith University, Brisbane, Australia.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD009958.pub3']
3236,32481297,"Evaluation on the effect of acupuncture on patients with sepsis-induced myopathy (ACU-SIM pilot study): A single center, propensity-score stratified, assessor-blinded, prospective pragmatic controlled trial.","BACKGROUND


Sepsis-induced myopathy (SIM) is a disease that causes motor dysfunction in patients with sepsis. There is currently no targeted treatment for this disease. Acupuncture has shown considerable efficacy in the treatment of sepsis and muscle weakness. Therefore, our research aims to explore the effects of acupuncture on the improvement of muscle structure and function in SIM patients and on activities of daily living.
METHODS


The ACU-SIM pilot study is a single-center, propensity-score stratified, assessor-blinded, prospective pragmatic controlled trial (pCT) with a 1-year follow-up period. This study will be deployed in a multi-professional critical care department at a tertiary teaching hospital in Guangzhou, China. Ninety-eight intensive care unit subjects will be recruited and assigned to either the control group or the acupuncture group. Both groups will receive basic treatment for sepsis, and the acupuncture group will additionally receive acupuncture treatment. The primary outcomes will be the rectus femoris cross-sectional area, the Medical Research Council sum-score and time-to-event (defined as all-cause mortality or unplanned readmission to the intensive care unit due to invasive ventilation). The activities of daily living will be accessed by the motor item of the Functional Independence Measure. Recruitment will last for 2 years, and each patient will have a 1-year follow-up after the intervention.
DISCUSSION


There is currently no research on the therapeutic effects of acupuncture on SIM. The results of this study may contribute to new knowledge regarding early muscle atrophy and the treatment effect of acupuncture in SIM patients, and the results may also direct new approaches and interventions in these patients. This trial will serve as a pilot study for an upcoming multicenter real-world study.
TRIAL REGISTRATION


Chinese Clinical Trials Registry: ChiCTR-1900026308, registered on September 29th, 2019.",2020,"The results of this study may contribute to new knowledge regarding early muscle atrophy and the treatment effect of acupuncture in SIM patients, and the results may also direct new approaches and interventions in these patients.","['Ninety-eight intensive care unit subjects', 'SIM patients and on activities of daily living', 'multi-professional critical care department at a tertiary teaching hospital in Guangzhou, China', 'patients with sepsis-induced myopathy (ACU-SIM pilot study', 'patients with sepsis']","['acupuncture', 'Acupuncture', 'acupuncture treatment']","['rectus femoris cross-sectional area, the Medical Research Council sum-score and time-to-event (defined as all-cause mortality or unplanned readmission to the intensive care unit due to invasive ventilation']","[{'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0026848', 'cui_str': 'Disorder of muscle'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]",,0.162219,"The results of this study may contribute to new knowledge regarding early muscle atrophy and the treatment effect of acupuncture in SIM patients, and the results may also direct new approaches and interventions in these patients.","[{'ForeName': 'Wei-Tao', 'Initials': 'WT', 'LastName': 'Chen', 'Affiliation': 'Intensive Care Unit, The First Affiliated Hospital of Guangzhou University of Chinese Medicine.'}, {'ForeName': 'Ce', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': 'Meizhou Hospital of Traditional Chinese Medicine, Meizhou.'}, {'ForeName': 'Ying-Bin', 'Initials': 'YB', 'LastName': 'Zhou', 'Affiliation': 'The First Clinical School of Guangzhou University of Chinese Medicine, Guangzhou.'}, {'ForeName': 'Dong-Hua', 'Initials': 'DH', 'LastName': 'Liu', 'Affiliation': 'The First Clinical School of Guangzhou University of Chinese Medicine, Guangzhou.'}, {'ForeName': 'Zhi-Long', 'Initials': 'ZL', 'LastName': 'Peng', 'Affiliation': 'The First Clinical School of Guangzhou University of Chinese Medicine, Guangzhou.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Intensive Care Unit, The First Affiliated Hospital of Guangzhou University of Chinese Medicine.'}, {'ForeName': 'Nuo', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'The university of Alabama at Birmingham, Birmingham, USA.'}, {'ForeName': 'Yan-Yan', 'Initials': 'YY', 'LastName': 'Lei', 'Affiliation': 'Intensive Care Unit, The First Affiliated Hospital of Guangzhou University of Chinese Medicine.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Acupuncture and Rehabilitation, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Chun-Zhi', 'Initials': 'CZ', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'Xin-Feng', 'Initials': 'XF', 'LastName': 'Lin', 'Affiliation': 'Intensive Care Unit, The First Affiliated Hospital of Guangzhou University of Chinese Medicine.'}, {'ForeName': 'Neng-Gui', 'Initials': 'NG', 'LastName': 'Xu', 'Affiliation': 'Guangzhou University of Chinese Medicine.'}, {'ForeName': 'Shao-Xiang', 'Initials': 'SX', 'LastName': 'Xian', 'Affiliation': 'Ling-Nan Medical Research Center, Guangzhou University of Chinese Medicine.'}, {'ForeName': 'Li-Ming', 'Initials': 'LM', 'LastName': 'Lu', 'Affiliation': 'Medical College of Acupuncture and Rehabilitation.'}]",Medicine,['10.1097/MD.0000000000020233']
3237,32481298,Clinical trial for conventional medicine integrated with traditional Chinese medicine (TCM) in the treatment of patients with chronic kidney disease.,"BACKGROUND


The prevalence of chronic kidney disease (CKD) has been rapidly increasing and has become one of the most concerned global health problems. It is of good importance to improve therapeutic efficiency of CKD and delay disease progression to end stage renal disease (ESRD). Traditional Chinese Medicine (TCM) is a widely used complementary therapy for patients with CKD. The aim of this study is to evaluate whether basic treatment combined with Chinese herbs mixture Qi Gui Yi Shen decoction could achieve better therapeutic effect on CKD patients.
METHODS


To determine whether traditional Chinese medicine Qi Gui Yi Shen decoction could achieve better therapeutic effect, we will conduct a randomized controlled trial. A total of 100 CKD patients that meet the inclusion criteria will be enrolled and divided into 2 groups: Qi Gui Yi Shen group (QGYS group) and placebo group. Each group will receive 6-monthly basic treatment in combination with TCM or placebo 3 times per day. Efficacy of Qi Gui Yi Shen decoction is evaluated by analyzing renal function and TCM symptoms, other efficacy assessments include serum level of PAI-I, expression of transforming growth factor beta1 (TGF-beta1). Routine blood count, plasma albumin (ALB), and alanine transaminase (ALT) are evaluated as side effect and safety profile.
DISCUSSION


The results from the clinical trial will provide evidence for the effectiveness and safety of Qi Gui Yi Shen Decoction as a treatment for CKD patients. Furthermore, this will propose a new theory and method for CKD treatment.
TRIAL REGISTRATION


Registered with Chinese Clinical Trials Registry at www.chictr.org. (Registration number: ChiCTR1900021622) on 1 March 2019.",2020,The results from the clinical trial will provide evidence for the effectiveness and safety of Qi Gui Yi Shen Decoction as a treatment for CKD patients.,"['100 CKD patients that meet the inclusion criteria will be enrolled and divided into 2 groups', 'CKD patients', 'patients with CKD', 'chronic kidney disease (CKD', 'patients with chronic kidney disease']","['Qi Gui Yi Shen decoction', 'Qi Gui Yi Shen group (QGYS group) and placebo', 'TCM or placebo', 'Qi Gui Yi Shen Decoction', 'Chinese herbs mixture', 'conventional medicine integrated with traditional Chinese medicine (TCM', 'Traditional Chinese Medicine (TCM', 'traditional Chinese medicine Qi Gui Yi Shen decoction']","['Routine blood count, plasma albumin (ALB), and alanine transaminase (ALT', 'renal function and TCM symptoms, other efficacy assessments include serum level of PAI-I, expression of transforming growth factor beta1 (TGF-beta1', 'side effect and safety profile']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0019240', 'cui_str': 'Herb'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0005771', 'cui_str': 'Blood cell count'}, {'cui': 'C0857876', 'cui_str': 'Plasma albumin'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032145', 'cui_str': 'Plasminogen activator inhibitor'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1704256', 'cui_str': 'Transforming Growth Factor Beta 1'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",100.0,0.0630156,The results from the clinical trial will provide evidence for the effectiveness and safety of Qi Gui Yi Shen Decoction as a treatment for CKD patients.,"[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xi', 'Affiliation': 'The First Affiliated Hospital of Soochow University.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'Suzhou Municipal Hospital, Suzhou.'}, {'ForeName': 'Like', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Zhangjiagang TCM Hospital, Zhangjiagang.'}, {'ForeName': 'Xiaoyi', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'The First Affiliated Hospital of Soochow University.'}, {'ForeName': 'Yuqin', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'The First Affiliated Hospital of Soochow University.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Minggang', 'Initials': 'M', 'LastName': 'Wei', 'Affiliation': 'The First Affiliated Hospital of Soochow University.'}]",Medicine,['10.1097/MD.0000000000020234']
3238,32481305,"A multi-center, randomized, double-blind, placebo-parallel controlled trial for the efficacy and safety of shenfuqiangxin pills in the treatment of chronic heart failure (Heart-Kidney yang deficiency syndrome).","BACKGROUND


Heart failure (HF) is the final stage of various cardiac diseases with poor prognosis. The integrated traditional Chinese medicine (TCM) and western medicine therapy has been considered as a prospective therapeutic strategy for chronic heart failure (CHF). There have been small clinical trials and experimental studies to demonstrate the efficacy of Shenfu Qiangxin Pills (SFQX) for treating CHF, however, there is still a lack of further high-quality trial. This paper describes the protocol for the clinical assessment of SFQX in CHF (heart-kidney Yang deficiency syndrome) patients.
METHODS


A randomized, double-blind, parallel-group, placebo-controlled, multi-center trial will assess the efficacy and safety of SFQX in the treatment of CHF. 352 patients with CHF (heart-kidney Yang deficiency syndrome) from 22 hospitals in China will be enrolled. Besides their standardized western medicine, patients will be randomized to receive treatment of either SFQX or placebo for 12 weeks. The primary outcome is the plasma N-terminal pro-B-type natriuretic peptide levels, which will be measured uniformly by the central laboratory. The secondary outcomes include composite endpoint events (hospitalization due to worsening HF, all-cause mortality, other serious cardiovascular events), echocardiography indicators, grades of the New York Heart Association (NYHA) functional classification, the 6-minute walk test (6MWT) results, Minnesota Living With Heart Failure Questionnaire and TCM syndrome scores.
DISCUSSION


The integrated TCM and western medicine therapy has developed into a treatment model in China. The rigorous design of the trial will assure an objective and scientific assessment of the efficacy and safety of SFQX in the treatment of CHF.
TRIAL REGISTRATION


Chinese Clinical Trial Registry: ChiCTR2000028777 (registered on January 3, 2020).",2020,"The secondary outcomes include composite endpoint events (hospitalization due to worsening HF, all-cause mortality, other serious cardiovascular events), echocardiography indicators, grades of the New York Heart Association (NYHA) functional classification, the 6-minute walk test (6MWT) results, Minnesota Living With Heart Failure Questionnaire and TCM syndrome scores.
","['352 patients with CHF (heart-kidney Yang deficiency syndrome) from 22 hospitals in China will be enrolled', 'chronic heart failure (Heart-Kidney yang deficiency syndrome', 'CHF (heart-kidney Yang deficiency syndrome) patients']","['SFQX or placebo', 'integrated traditional Chinese medicine (TCM) and western medicine therapy', 'Shenfu Qiangxin Pills (SFQX', 'shenfuqiangxin pills', 'SFQX', 'placebo']","['efficacy and safety', 'composite endpoint events (hospitalization due to worsening HF, all-cause mortality, other serious cardiovascular events), echocardiography indicators, grades of the New York Heart Association (NYHA) functional classification, the 6-minute walk test (6MWT) results, Minnesota Living With Heart Failure Questionnaire and TCM syndrome scores', 'plasma N-terminal pro-B-type natriuretic peptide levels, which will be measured uniformly by the central laboratory']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0085258', 'cui_str': 'Yang deficiency'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C1528398', 'cui_str': 'Shen-Fu'}, {'cui': 'C2355395', 'cui_str': 'qiangxin'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]",352.0,0.220512,"The secondary outcomes include composite endpoint events (hospitalization due to worsening HF, all-cause mortality, other serious cardiovascular events), echocardiography indicators, grades of the New York Heart Association (NYHA) functional classification, the 6-minute walk test (6MWT) results, Minnesota Living With Heart Failure Questionnaire and TCM syndrome scores.
","[{'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'National Priority R & D Programmes (2018YFC1707410-02), Cardiovascular Disease Center, Xiyuan Hospital of China Academy of Chinese Medical Sciences.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': 'National Priority R & D Programmes (2018YFC1707410-02), Cardiovascular Disease Center, Xiyuan Hospital of China Academy of Chinese Medical Sciences.'}, {'ForeName': 'Dawu', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'National Priority R & D Programmes (2018YFC1707410-02), Cardiovascular Disease Center, Xiyuan Hospital of China Academy of Chinese Medical Sciences.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'National priority R & D programmes (2018YFC1707410-02), Fuwai Hospital of Chinese Academy of Medical Sciences.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Hua', 'Affiliation': 'National Priority R & D Programmes (2018YFC1707410-02), Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiaochang', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'National Priority R & D Programmes (2018YFC1707410-02), Cardiovascular Disease Center, Xiyuan Hospital of China Academy of Chinese Medical Sciences.'}, {'ForeName': 'Keji', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'National Priority R & D Programmes (2018YFC1707410-02), Cardiovascular Disease Center, Xiyuan Hospital of China Academy of Chinese Medical Sciences.'}]",Medicine,['10.1097/MD.0000000000020271']
3239,32485325,A pharmacy liaison-patient navigation intervention to reduce inpatient and emergency department utilization among primary care patients in a Medicaid accountable care organization: A pragmatic trial protocol.,"OBJECTIVE


To determine whether employing the services of a pharmacy liaison to promote medication adherence (usual care), relative to a pharmacy liaison with training in motivational interviewing and as a patient navigator who systematically screens for health-related social needs and provides targeted navigation services to connect patients with appropriate community resources in partnership with a community-based organization (enhanced usual care), will reduce inpatient hospital admissions and emergency department visits among patients who are members of a Medicaid ACO and receive primary care at a large urban safety-net hospital.
BACKGROUND


Prior studies have demonstrated only modest effects in reducing utilization among safety-net patient populations. Interventions that address health-related social needs have the potential to reduce utilization in these populations.
DESIGN/METHODS


Assignment to treatment condition is by medical record number (odd vs. even) and is unblinded (NCT03919084). Adults age 18-64 within the 3rd to 10th percentile for health care utilization and cost among Medicaid Accountable Care Organization membership attending a primary care visit in the general internal medicine practice at Boston Medical Center enrolled.
DISCUSSION


Our study will advance the field in two ways: 1) by providing evidence about the effectiveness of pharmacy liaisons who also function as patient navigators; and 2) by de-implementing patient navigators. Patients in the enhanced usual care arm will no longer receive the services of a clinic-based patient navigator. In addition, our study includes a novel collaboration with a community-based organization, and focuses on an intermediate-cost patient population, rather than the most costly patient population.",2020,"OBJECTIVE


To determine whether employing the services of a pharmacy liaison to promote medication adherence (usual care), relative to a pharmacy liaison with training in motivational interviewing and as a patient navigator who systematically screens for health-related social needs and provides targeted navigation services to connect patients with appropriate community resources in partnership with a community-based organization (enhanced usual care), will reduce inpatient hospital admissions and emergency department visits among patients who are members of a Medicaid ACO and receive primary care at a large urban safety-net hospital.
","['connect patients with appropriate community resources in partnership with a community-based organization (enhanced usual care), will reduce inpatient hospital admissions and emergency department visits among patients who are members of a Medicaid ACO and receive primary care at a large urban safety-net hospital', 'Adults age 18-64 within the 3rd to 10th percentile for health care utilization and cost among Medicaid Accountable Care Organization membership attending a primary care visit in the general internal medicine practice at Boston Medical Center enrolled', 'primary care patients in a Medicaid accountable care organization']",['pharmacy liaison-patient navigation intervention'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0239966', 'cui_str': 'Hospital patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C3661443', 'cui_str': 'Safety-net Hospitals'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3179030', 'cui_str': 'Accountable Care Organization'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}]","[{'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0200654,"OBJECTIVE


To determine whether employing the services of a pharmacy liaison to promote medication adherence (usual care), relative to a pharmacy liaison with training in motivational interviewing and as a patient navigator who systematically screens for health-related social needs and provides targeted navigation services to connect patients with appropriate community resources in partnership with a community-based organization (enhanced usual care), will reduce inpatient hospital admissions and emergency department visits among patients who are members of a Medicaid ACO and receive primary care at a large urban safety-net hospital.
","[{'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Lasser', 'Affiliation': 'Section of General Internal Medicine, Boston Medical Center, 801 Massachusetts Ave, 6th Floor, Boston, MA 02119, USA; Boston University School of Medicine, 72 E Concord St, Boston, MA 02118, USA; Boston University School of Public Health, 715 Albany St, Boston, MA 02118, USA; Boston Medical Center, One Boston Medical Center Pl, Boston, MA 02118, USA. Electronic address: Karen.Lasser@bmc.org.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Buitron de la Vega', 'Affiliation': 'Section of General Internal Medicine, Boston Medical Center, 801 Massachusetts Ave, 6th Floor, Boston, MA 02119, USA; Boston University School of Medicine, 72 E Concord St, Boston, MA 02118, USA; Boston Medical Center, One Boston Medical Center Pl, Boston, MA 02118, USA. Electronic address: Pablo.BuitrondelaVega@bmc.org.'}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Ashe', 'Affiliation': 'Boston Medical Center, One Boston Medical Center Pl, Boston, MA 02118, USA. Electronic address: Erin.Ashe@bmc.org.'}, {'ForeName': 'Ziming', 'Initials': 'Z', 'LastName': 'Xuan', 'Affiliation': 'Boston University School of Public Health, 715 Albany St, Boston, MA 02118, USA. Electronic address: zxuan@bu.edu.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Alva', 'Affiliation': 'Boston Medical Center, One Boston Medical Center Pl, Boston, MA 02118, USA. Electronic address: Sonia.Alva@bmc.org.'}, {'ForeName': 'Leandra', 'Initials': 'L', 'LastName': 'Battisti', 'Affiliation': 'Boston Medical Center, One Boston Medical Center Pl, Boston, MA 02118, USA. Electronic address: Leandra.Battisti@bmc.org.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Losi', 'Affiliation': 'Boston Medical Center, One Boston Medical Center Pl, Boston, MA 02118, USA. Electronic address: Stephanie.Losi@bmc.org.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Sieber', 'Affiliation': 'Action for Boston Community Development Inc., 178 Tremont St, Boston, MA 02111, USA. Electronic address: Christina.Sieber@bostonabcd.org.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Richards', 'Affiliation': 'Action for Boston Community Development Inc., 178 Tremont St, Boston, MA 02111, USA. Electronic address: Carla.Richards@bostonabcd.org.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Sullivan', 'Affiliation': 'Action for Boston Community Development Inc., 178 Tremont St, Boston, MA 02111, USA. Electronic address: Patricia.Sullivan@bostonabcd.org.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Triscari', 'Affiliation': 'Action for Boston Community Development Inc., 178 Tremont St, Boston, MA 02111, USA. Electronic address: Leah.Triscari@bostonabcd.org.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Brody', 'Affiliation': 'Action for Boston Community Development Inc., 178 Tremont St, Boston, MA 02111, USA. Electronic address: Lauren.Brody@bostonabcd.org.'}, {'ForeName': 'Mary-Tara', 'Initials': 'MT', 'LastName': 'Roth', 'Affiliation': 'Clinical Research Resources Office, Boston Medical Center, Boston University Medical Campus, 75 E Newton St, Evans Building, 7(th) Floor, Boston, MA 02118, USA. Electronic address: Mary-Tara.Roth@bmc.org.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'LeBlanc', 'Affiliation': 'Boston Medical Center, One Boston Medical Center Pl, Boston, MA 02118, USA. Electronic address: Alison.LeBlanc@bmc.org.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Silverstein', 'Affiliation': 'Boston University School of Medicine, 72 E Concord St, Boston, MA 02118, USA; Section of General Academic Pediatrics, Boston Medical Center, 72 East Concord St, Vose Building, 3(rd) Floor, Boston, MA 02118, USA. Electronic address: Michael.Silverstein@bmc.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106046']
3240,32485328,Randomized trial of argatroban plus recombinant tissue-type plasminogen activator for acute ischemic stroke (ARAIS): Rationale and design.,"BACKGROUND


Previous studies have implied the efficacy and safety of argatroban plus recombinant tissue-type plasminogen activator (r-tPA) in patients with acute ischemic stroke. Further trials are needed to establish convincing conclusions in a large sample size.
RESEARCH DESIGN AND METHODS


Argatroban plus r-tPA for Acute Ischemic Stroke (ARAIS) trial is a multicenter, prospective, randomized, open-label, and blind-end point trial. The trial proposes to randomize 808 patients with acute ischemic stroke National Institutes of Health Stroke Scale (NIHSS score≥ 6 at the time of randomization) within 4.5 hours of symptom onset to receive argatroban (100 μg/kg bolus followed by an infusion of 1.0 μg/kg per minute for 48 hours) plus r-tPA or r-tPA alone. The primary end point is the proportion of patients with an excellent outcome of no clinically significant residual stroke deficits (modified Rankin scale 0-1) at 90 days. Secondary end points include the proportion of patients with a good outcome (modified Rankin scale 0-2) at 90 days, early neurological improvement (NIHSS score ≥2-point decrease) at 48 hours, early neurological deterioration (NIHSS score ≥4-point increase) at 48 hours, decrease in the NIHSS score from baseline to 14 days, and stroke recurrence or other vascular events at 90 days. Safety end points include symptomatic intracerebral hemorrhage, parenchymal hematoma type 2, and major systemic bleeding.
CONCLUSION


ARAIS trial will evaluate whether argatroban plus r-tPA is superior to r-tPA alone in improving functional outcomes in acute ischemic stroke patients in a large sample population.",2020,"Secondary end points include the proportion of patients with a good outcome (modified Rankin scale 0-2) at 90 days, early neurological improvement (NIHSS score ≥2-point decrease) at 48 hours, early neurological deterioration (NIHSS score ≥4-point increase) at 48 hours, decrease in the NIHSS score from baseline to 14 days, and stroke recurrence or other vascular events at 90 days.","['acute ischemic stroke (ARAIS', 'acute ischemic stroke patients in a large sample population', '808 patients with acute ischemic stroke National Institutes of Health Stroke Scale (NIHSS score≥ 6 at the time of randomization) within 4.5\u202fhours of symptom onset to receive', 'patients with acute ischemic stroke']","['argatroban plus recombinant tissue-type plasminogen activator (r-tPA', 'argatroban plus r-tPA', 'argatroban plus recombinant tissue-type plasminogen activator', 'Argatroban plus r-tPA', 'argatroban (100\u202fμg/kg bolus followed by an infusion of 1.0\u202fμg/kg per minute for 48\u202fhours) plus r-tPA or r-tPA alone']","['stroke recurrence or other vascular events', 'symptomatic intracerebral hemorrhage, parenchymal hematoma type 2, and major systemic bleeding', 'NIHSS score', 'proportion of patients with a good outcome (modified Rankin scale 0-2) at 90\u202fdays, early neurological improvement (NIHSS score\u202f≥2-point decrease) at 48\u202fhours, early neurological deterioration (NIHSS score\u202f≥4-point increase', 'functional outcomes', 'proportion of patients with an excellent outcome of no clinically significant residual stroke deficits']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0048470', 'cui_str': 'argatroban'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3472496', 'cui_str': 'National Institutes of Health stroke scale'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0048470', 'cui_str': 'argatroban'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0439586', 'cui_str': '48 hours'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}]",808.0,0.128243,"Secondary end points include the proportion of patients with a good outcome (modified Rankin scale 0-2) at 90 days, early neurological improvement (NIHSS score ≥2-point decrease) at 48 hours, early neurological deterioration (NIHSS score ≥4-point increase) at 48 hours, decrease in the NIHSS score from baseline to 14 days, and stroke recurrence or other vascular events at 90 days.","[{'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China; Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhonghe', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, General Hospital of Northern Theater Command, Shenyang, Liaoning, China.'}, {'ForeName': 'Yuesong', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China; Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing, China.'}, {'ForeName': 'Huisheng', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, General Hospital of Northern Theater Command, Shenyang, Liaoning, China. Electronic address: chszh@aliyun.com.'}, {'ForeName': 'Yilong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China; Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing, China. Electronic address: yilong528@gmail.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.04.003']
3241,32485422,Utilizing the somatosensory system via vibratory stimulation to mitigate knee pain during walking: Randomized clinical trial.,"BACKGROUND


Pain and proprioception deficits are often associated with knee pathologies and resultant quadriceps muscle inhibition. There is a need for new approaches to mitigate active knee pain and restore muscle function during walking. Activating properties of the somatosensory system with common pain and sensory pathways offers a novel opportunity to enhance quadriceps function during walking.
RESEARCH QUESTION


Conduct a controlled clinical trial that investigates the effects of applying intermittent vibrational cutaneous stimulation during walking on knee pain and symptoms and their correlations to gait parameters.
METHODS


This longitudinal controlled cross-over clinical study included thirty-two patients randomly and blindly assigned to active Treatment A and passive Treatment B for 4 weeks with a 2-week washout period between treatments.
RESULTS


Subjects when wearing active Treatment A for 4 weeks had significant (p = 0.04) improvement in patient reported outcomes, while they had no significant differences with passive Treatment B (p > 0.7) compared to the no treatment condition. For Treatment A, subjects with low knee flexion moment and knee flexion angle in no-treatment condition exhibited the greatest increase in knee flexion moment/angle in the active treatment condition (R > 0.57, p < 0.001). These changes in gait measures were correlated significantly to changes in pain.
SIGNIFICANCE


This clinical trial indicates that knee pain can be reduced, and gait improved in a manner that enhances quadriceps function by applying intermittent cutaneous stimulation during gait in patients following knee injury or disease. The correlation between decreased pain and improved gait suggests that rehabilitation and exercise therapy may benefit from this treatment.",2020,"RESULTS


Subjects when wearing active Treatment A for 4 weeks had significant (p = 0.04) improvement in patient reported outcomes, while they had no significant differences with passive Treatment B (p > 0.7) compared to the no treatment condition.",['knee pain during walking'],"['somatosensory system via vibratory stimulation', 'intermittent vibrational cutaneous stimulation']","['knee flexion moment/angle', 'gait measures', 'pain']","[{'cui': 'C0231749', 'cui_str': 'Knee pain'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0150184', 'cui_str': 'Cutaneous stimulation'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",32.0,0.0771875,"RESULTS


Subjects when wearing active Treatment A for 4 weeks had significant (p = 0.04) improvement in patient reported outcomes, while they had no significant differences with passive Treatment B (p > 0.7) compared to the no treatment condition.","[{'ForeName': 'Arielle G', 'Initials': 'AG', 'LastName': 'Fischer', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA. Electronic address: ariellef@stanford.edu.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Erhart-Hledik', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA; Palo Alto Veterans Hospital, Palo Alto, CA, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Asay', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA; Palo Alto Veterans Hospital, Palo Alto, CA, USA.'}, {'ForeName': 'Constance R', 'Initials': 'CR', 'LastName': 'Chu', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA; Palo Alto Veterans Hospital, Palo Alto, CA, USA.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Andriacchi', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA.'}]",Gait & posture,['10.1016/j.gaitpost.2020.05.030']
3242,32482626,Prioritisation of treatment goals among older patients with non-curable cancer: the OPTion randomised controlled trial in Dutch primary care.,"BACKGROUND


Older patients with cancer often find it difficult to take part in shared decision making.
AIM


To assess the utility of the Outcome Prioritisation Tool (OPT), designed to aid discussion with a patient in regards to their treatment goals, to empower patients with cancer through structured conversations about generic treatment goals with GPs.
DESIGN AND SETTING


A randomised controlled trial of 114 Dutch participants recruited between November 2015 and January 2019, aged ≥60 years with non-curable cancer who had to make a treatment decision with an oncologist. The intervention group used the OPT while the control group received care as usual.
METHOD


The primary outcome was patient empowerment using the score on the decision self-efficacy (DSE) scale. Secondary outcomes were symptoms measures of fatigue, anxiety, and depression. The experiences of participants were also explored.
RESULTS


No effect was found on patient empowerment between the OPT group ( n  = 48; DSE 86.8; standard deviation [SD] = 18.2) and the control group ( n  = 58; DSE 84.2; SD = 17.6;  P  = 0.47). In the OPT group, although statistically non-significant, fewer patients had low empowerment (18.8%,  n  = 9 versus 24.1%,  n  = 14; P = 0.50), but they did have statistically significant lower mean anxiety scores (6.0, SD = 4.6 versus 7.6, SD = 4.4; P<0.05) and less mild fatigue (58.8%,  n  = 30 versus 77.2%,  n  = 44;  P  = 0.05). Overall, 44.8% ( n  = 13) of patients indicated that the OPT-facilitated conversation helped them make a treatment decision, and 31.1% ( n  = 14) of the GPs reported that they gained new insights from the conversation.
CONCLUSION


An OPT-facilitated conversation about generic treatment goals between patients and their GPs is associated with less anxiety and fatigue, but did not show statistically significant improvements in patient empowerment. Adding the OPT to routine care might ensure more patient-tailored care.",2020,"In the OPT group, although statistically non-significant, fewer patients had low empowerment (18.8%,  n  = 9 versus 24.1%,  n  = 14; P = 0.50), but they did have statistically significant lower mean anxiety scores (6.0, SD = 4.6 versus 7.6, SD = 4.4; P<0.05) and less mild fatigue (58.8%,  n  = 30 versus 77.2%,  n  = 44;  P  = 0.05).","['Older patients with cancer', 'older patients with non-curable cancer', 'patients with cancer through structured conversations about generic treatment goals with GPs', '114 Dutch participants recruited between November 2015 and January 2019, aged ≥60 years with non-curable cancer who had to make a treatment decision with an oncologist']","['OPT while the control group received care as usual', 'Outcome Prioritisation Tool (OPT']","['symptoms measures of fatigue, anxiety, and depression', 'patient empowerment using the score on the decision self-efficacy (DSE) scale', 'mild fatigue', 'anxiety and fatigue', 'patient empowerment', 'mean anxiety scores', 'low empowerment']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0272302', 'cui_str': 'Gray platelet syndrome'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3853035', 'cui_str': 'Patient Empowerment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}]",114.0,0.0458868,"In the OPT group, although statistically non-significant, fewer patients had low empowerment (18.8%,  n  = 9 versus 24.1%,  n  = 14; P = 0.50), but they did have statistically significant lower mean anxiety scores (6.0, SD = 4.6 versus 7.6, SD = 4.4; P<0.05) and less mild fatigue (58.8%,  n  = 30 versus 77.2%,  n  = 44;  P  = 0.05).","[{'ForeName': 'Mariken E', 'Initials': 'ME', 'LastName': 'Stegmann', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Daan', 'Initials': 'D', 'LastName': 'Brandenbarg', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'An Kl', 'Initials': 'AK', 'LastName': 'Reyners', 'Affiliation': 'Department of Medical Oncology, University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Wouter H', 'Initials': 'WH', 'LastName': 'van Geffen', 'Affiliation': 'Department of Pulmonary Diseases, Medical Centre Leeuwarden, Leeuwarden, the Netherlands.'}, {'ForeName': 'T Jeroen N', 'Initials': 'TJN', 'LastName': 'Hiltermann', 'Affiliation': 'Department of Pulmonary Diseases and Tuberculosis, University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Annette J', 'Initials': 'AJ', 'LastName': 'Berendsen', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/bjgp20X710405']
3243,32479140,Cost per responder for guselkumab versus secukinumab in the United States based on a head-to-head trial of moderate to severe plaque psoriasis .,"Aims:  To estimate cost per response (CPR) in the United States and number-needed-to-treat (NNT) among subjects receiving guselkumab or secukinumab for moderate to severe plaque psoriasis. Materials and methods:  Results from ECLIPSE, a double-blind, head-to-head, 48-week study of guselkumab compared with secukinumab were used to estimate 48-week, annual induction, and maintenance year CPRs for Psoriasis Area and Severity Index (PASI) 75, 90, and 100 responses for all patients and for PASI 90 response in patients according to previous systemic treatment. Results:  Week 48 PASI 90 response rates were 84.5% for guselkumab and 70.0% for secukinumab. The CPR for PASI 90 response at 48 weeks was $89,960 for guselkumab versus $110,977 for secukinumab, and for the maintenance year it was $77,109 for guselkumab versus $88,781 for secukinumab. The NNT for a PASI 90 response was 1.18 for guselkumab and 1.43 for secukinumab. CPR and NNT values were also lower for guselkumab than for secukinumab, for PASI 75 and PASI 100 for the three time periods, and for PASI 90 at 48-weeks, regardless of previous systemic treatment. Conclusions:  Results from a head-to-head study showed that, compared with secukinumab, guselkumab had lower NNTs and CPRs for PASI 75, PASI 90, and PASI 100 responses.",2020,"CPR and NNT values were also lower for guselkumab than for secukinumab, for PASI 75 and PASI 100 for the three time periods, and for PASI 90 at 48-weeks, regardless of previous systemic treatment.",['subjects receiving guselkumab or secukinumab for moderate to severe plaque psoriasis'],['guselkumab versus secukinumab'],"['CPR and NNT values', 'PASI 90 response rates', 'cost per response (CPR']","[{'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}]","[{'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}]","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.156471,"CPR and NNT values were also lower for guselkumab than for secukinumab, for PASI 75 and PASI 100 for the three time periods, and for PASI 90 at 48-weeks, regardless of previous systemic treatment.","[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Teeple', 'Affiliation': 'Real World Value & Evidence, Janssen Scientific Affairs LLC, Horsham, PA, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Fitzgerald', 'Affiliation': 'Real World Value & Evidence, Janssen Scientific Affairs LLC, Horsham, PA, USA.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1770172']
3244,32480076,Microstructural white matter changes following gait training with Hybrid Assistive Limb initiated within 1 week of stroke onset.,"The early initiation of robot-assisted gait training in patients with acute stroke could promote neuroplasticity. The aim of this study was to clarify the microstructural changes of white matter associated with gait training using Hybrid Assistive Limb (HAL) by diffusion tensor imaging (DTI). Patients with first-ever stroke and requiring a walking aid started gait training within 1 week of stroke onset. The patients were quasi-randomly assigned either to the conventional physical therapy (CPT) group or gait training using HAL (HAL) group. Motor function and DTI were examined at baseline and after 3-5 months. Voxel-based statistical analyses of fractional anisotropy (FA) images were performed using diffusion metric voxel-wise analyses. Volume of interest (VOI)-based analyses were used to assess changes in FA (ΔFA). Twenty-seven patients (17 in the CPT group and 10 in the HAL group) completed the study. There were improvements in motor function and independency in the CPT and HAL groups (p < .001). Compared to baseline, there were decreases in FA in the ipsi-lesional cerebral peduncle in the CPT group (p < .001) and increases in the contra-lesional rostrum of the corpus callosum in the HAL group (p < .001) at the second assessment, consistent with the mean ΔFA in each group from VOI analysis (CPT/HAL: cerebral peduncle, -0.066/-0.027, p = .027; corpus callosum, 0.002/0.042, p < .001). Gait training using HAL initiated within 1 week after stroke onset facilitated the recovery of inter-hemispheric communication and prevented the progression of Wallerian degeneration of the affected pyramidal tract.",2020,"Compared to baseline, there were decreases in FA in the ipsi-lesional cerebral peduncle in the CPT group (p < .001) and increases in the contra-lesional rostrum of the corpus callosum in the HAL group (p < .001) at the second assessment, consistent with the mean ΔFA in each group from VOI analysis (CPT/HAL: cerebral peduncle, -0.066/-0.027, p = .027; corpus callosum, 0.002/0.042, p < .001).","['Twenty-seven patients (17 in the CPT group and 10 in the HAL group) completed the study', 'Patients with first-ever stroke and requiring a walking aid started gait training within 1\xa0week of stroke onset', 'patients with acute stroke']","['Gait training using HAL', 'gait training using Hybrid Assistive Limb (HAL) by diffusion tensor imaging (DTI', 'robot-assisted gait training', 'conventional physical therapy (CPT) group or gait training using HAL (HAL', 'gait training with Hybrid Assistive Limb']","['Motor function and DTI', 'changes in FA (ΔFA', 'contra-lesional rostrum of the corpus callosum', 'motor function and independency', 'FA in the ipsi-lesional cerebral peduncle']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}]","[{'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0152322', 'cui_str': 'Structure of rostrum of corpus callosum'}, {'cui': 'C0007793', 'cui_str': 'Cerebral peduncle structure'}]",27.0,0.0293157,"Compared to baseline, there were decreases in FA in the ipsi-lesional cerebral peduncle in the CPT group (p < .001) and increases in the contra-lesional rostrum of the corpus callosum in the HAL group (p < .001) at the second assessment, consistent with the mean ΔFA in each group from VOI analysis (CPT/HAL: cerebral peduncle, -0.066/-0.027, p = .027; corpus callosum, 0.002/0.042, p < .001).","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Ando', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Chiaki', 'Initials': 'C', 'LastName': 'Yokota', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan; Department of Stroke Rehabilitation, National Cerebral and Cardiovascular Center, Suita, Japan. Electronic address: cyokota@ncvc.go.jp.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Koshino', 'Affiliation': 'Department of Systems and Informatics, Hokkaido Information University, Ebetsu, Japan. Electronic address: koshino@do-johodai.ac.jp.'}, {'ForeName': 'Fumihiko', 'Initials': 'F', 'LastName': 'Yasuno', 'Affiliation': 'Department of Psychiatry, National Center for Geriatrics and Gerontology, Obu, Aichi, Japan. Electronic address: yasunof@ncgg.go.jp.'}, {'ForeName': 'Takeo', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Akihide', 'Initials': 'A', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Industrial-Academic Collaboration, Open Innovation Center, National Cerebral and Cardiovascular Center, Suita, Japan. Electronic address: ayamamot@ncvc.go.jp.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Odani', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Nakajima', 'Affiliation': 'Department of Neurology, National Hospital Organization Niigata National Hospital, Kashiwazaki, Japan. Electronic address: nakajima.takashi.ud@mail.hosp.go.jp.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Higuchi', 'Affiliation': 'Department of Nuclear Medicine and Comprehensive Heart Failure Center, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Eisuke', 'Initials': 'E', 'LastName': 'Tatsumi', 'Affiliation': 'Open Innovation Center, National Cerebral and Cardiovascular Center, Suita, Japan. Electronic address: tatsumi@ncvc.go.jp.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116939']
3245,32481239,"Sensorimotor and gait training improves proprioception, nerve function, and muscular activation in patients with diabetic peripheral neuropathy: a randomized control trial.","OBJECTIVES


To examine the effect of sensorimotor and gait training on proprioception, nerve function, and muscle activation in diabetic peripheral neuropathy (DPN) patients.
METHODS


Thirty-eight (25 male and 13 female) participants with DPN were selected and randomly allocated to intervention and control group. Participants in the intervention group were provided sensorimotor and gait training for eight weeks (3 days/week) along with diabetes and foot care education; participants in the control group received diabetes and foot care education only. Outcome measures involved proprioception, nerve conduction studies of peroneal and tibial nerve, and activation of lower limb muscles and multifidus while standing with eyes open and eyes closed, and treadmill walking.
RESULTS


Mixed ANOVA revealed significant time effect and time×group interaction of proprioception in all four directions (p<0.05). The conduction velocity of peroneal nerve revealed significant time effect (p=0.007) and time×group interaction (p=0.022). Interaction effect was found to be significant for medial gastrocnemius and multifidus while standing with eyes open as well as with eyes closed (p≤0.004). Only multifidus showed significant group (p=0.002) and interaction effect (p=0.003) during walking.
CONCLUSIONS


Sensorimotor and gait training is an effective tool for improvement of proprioception and nerve function. It benefits muscle activation around ankle and multifidus during postural control and walking in DPN patients. Clinical Trials Registry - India, National Institute of Medical Statistics (Indian Council of Medical Research): Registration Number - CTRI/2017/08/009328.",2020,The conduction velocity of peroneal nerve revealed significant time effect (p=0.007) and time×group interaction (p=0.022).,"['Thirty-eight', 'diabetic peripheral neuropathy (DPN) patients', 'patients with diabetic peripheral neuropathy', 'DPN patients', '25 male and 13 female) participants with DPN']","['control group received diabetes and foot care education only', 'Sensorimotor and gait training', 'sensorimotor and gait training']","['proprioception, nerve function, and muscular activation', 'proprioception, nerve function, and muscle activation', 'interaction effect', 'proprioception, nerve conduction studies of peroneal and tibial nerve, and activation of lower limb muscles and multifidus while standing with eyes open and eyes closed, and treadmill walking', 'time effect and time×group interaction of proprioception', 'Interaction effect', 'conduction velocity of peroneal nerve revealed significant time effect']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0740447', 'cui_str': 'Diabetic peripheral neuropathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1161230', 'cui_str': 'Foot care education'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]","[{'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0200125', 'cui_str': 'Nerve conduction study'}, {'cui': 'C0442035', 'cui_str': 'Peroneal'}, {'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0224319', 'cui_str': 'Structure of multifidus muscle'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0266574', 'cui_str': 'Ablepharon'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0234084', 'cui_str': 'Conduction rate of nerve cell and nerve fiber'}, {'cui': 'C0031173', 'cui_str': 'Structure of common peroneal nerve'}, {'cui': 'C0443289', 'cui_str': 'Revealed'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]",,0.0376785,The conduction velocity of peroneal nerve revealed significant time effect (p=0.007) and time×group interaction (p=0.022).,"[{'ForeName': 'Irshad', 'Initials': 'I', 'LastName': 'Ahmad', 'Affiliation': 'Diabetes Research Group, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia (A Central University), New Delhi, India.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': 'Diabetes Research Group, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia (A Central University), New Delhi, India.'}, {'ForeName': 'Majumi M', 'Initials': 'MM', 'LastName': 'Noohu', 'Affiliation': 'Human Performance Lab, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia (A Central University), New Delhi, India.'}, {'ForeName': 'Mohd Yakub', 'Initials': 'MY', 'LastName': 'Shareef', 'Affiliation': 'Ansari Health Centre, Jamia Millia Islamia (A Central University), New Delhi, India.'}, {'ForeName': 'M Ejaz', 'Initials': 'ME', 'LastName': 'Hussain', 'Affiliation': 'Diabetes Research Group, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia (A Central University), New Delhi, India.'}]",Journal of musculoskeletal & neuronal interactions,[]
3246,32481240,Effects of aquatic exercises on postural control and hand function in Multiple Sclerosis: Halliwick versus Aquatic Plyometric Exercises: a randomised trial.,"OBJECTIVES


Postural control and hand dexterity are significantly impaired in people with multiple sclerosis (pwMS). Aquatic interventions may have additional benefits in the treatment of pwMS. The purpose of this study is to compare the effects of two different aquatic exercises on postural control and hand function.
METHODS


Thirty pwMS, relapsing-remitting type were randomly divided into a Halliwick (Hallw) and an Aquatic Plyometric Exercise (APE) group. The Limits of Stability test was used to evaluate postural control using the Biodex Balance System. The Nine-Hole Peg Test was used to evaluate hand dexterity. Both exercise interventions were performed twice a week for 8 weeks, in a pool with a depth of 120 cm and water temperature of 30-31°C.
RESULTS


Limits of stability improved significantly in both groups (p<0.05) and Hallw group completed the test in a significantly shorter time (p<0.05). Hand dexterity improved significantly in both groups (p<0.01). Following intergroup analysis, Hallw group showed significantly higher improvement in hand dexterity and overall limits of stability test score (p<0.05).
CONCLUSIONS


This study provides evidence that both Halliwick and APE are effective to treat balance and hand dexterity. This paper is the first evidence on APE for pwMS and showed that it is safe and improved trunk control and hand dexterity.",2020,"RESULTS


Limits of stability improved significantly in both groups (p<0.05) and Hallw group completed the test in a significantly shorter time (p<0.05).","['Thirty pwMS, relapsing-remitting type', 'people with multiple sclerosis (pwMS', 'Multiple Sclerosis']","['Halliwick (Hallw) and an Aquatic Plyometric Exercise (APE', 'aquatic exercises', 'Aquatic Plyometric Exercises']","['hand dexterity and overall limits of stability test score', 'Limits of stability', 'Hand dexterity', 'postural control and hand function']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}]",,0.030325,"RESULTS


Limits of stability improved significantly in both groups (p<0.05) and Hallw group completed the test in a significantly shorter time (p<0.05).","[{'ForeName': 'Baris', 'Initials': 'B', 'LastName': 'Gurpinar', 'Affiliation': 'Dokuz Eylul University School of Physical Therapy and Rehabilitation, Izmir, Turkey.'}, {'ForeName': 'Bilge', 'Initials': 'B', 'LastName': 'Kara', 'Affiliation': 'Dokuz Eylul University School of Physical Therapy and Rehabilitation, Izmir, Turkey.'}, {'ForeName': 'Egemen', 'Initials': 'E', 'LastName': 'Idiman', 'Affiliation': 'Private Clinic, Izmir, Turkey.'}]",Journal of musculoskeletal & neuronal interactions,[]
3247,32481241,Therapeutic value of kinesio taping in reducing lower back pain and improving back muscle endurance in adolescents with hemophilia.,"OBJECTIVE


This study evaluated whether the use of kinesio taping (KT) would enhance the effect of physical therapy in relieving pain, improving muscle endurance, and boosting functional capacity in adolescents with hemophilia who experience low back pain.
METHODS


Forty-five adolescents with hemophilia (age; 10-13 years) assigned randomly into three treatment arms; KT applied paraspinal alongside a physical exercise program conducted three times/week for three successive months (KT group; n=15), placebo taping plus physical exercise (Placebo group; n=15), or physical exercise only (Control group; n=15). Lower back pain, back muscle endurance, and functional capacity assessed pre- and post-treatment.
RESULTS


Lower back pain reduced significantly in the KT group as compared to the control group (P=.001), but not to the placebo group (P=.19). Back muscle endurance increased significantly in the KT group relative to either the placebo (P=.004) or the control group (P=.043). Additionally, functional capacity improved significantly in the KT group as compared to the control (P=.039) group but not to the placebo group (P=.58).
CONCLUSION


KT is an effective adjunctive therapy to reduce lower back pain, improve back muscle endurance, and enhance functional capacity in adolescents with hemophilia.",2020,"RESULTS


Lower back pain reduced significantly in the KT group as compared to the control group (P=.001), but not to the placebo group (P=.19).","['Forty-five adolescents with hemophilia (age; 10-13 years', 'adolescents with hemophilia who experience low back pain', 'adolescents with hemophilia']","['kinesio taping (KT', 'placebo taping plus physical exercise (Placebo', 'KT', 'kinesio taping', 'physical exercise', 'physical therapy', 'placebo']","['back pain', 'Lower back pain, back muscle endurance, and functional capacity assessed pre- and post-treatment', 'Back muscle endurance', 'functional capacity', 'lower back pain and improving back muscle endurance']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0224334', 'cui_str': 'Skeletal muscle structure of back'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",45.0,0.0300428,"RESULTS


Lower back pain reduced significantly in the KT group as compared to the control group (P=.001), but not to the placebo group (P=.19).","[{'ForeName': 'Alshimaa R', 'Initials': 'AR', 'LastName': 'Αzab', 'Affiliation': 'Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Ragab K', 'Initials': 'RK', 'LastName': 'Elnaggar', 'Affiliation': 'Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Reham H', 'Initials': 'RH', 'LastName': 'Diab', 'Affiliation': 'Department of Basic Sciences, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Samah A', 'Initials': 'SA', 'LastName': 'Moawd', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, Collage of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}]",Journal of musculoskeletal & neuronal interactions,[]
3248,32481255,A clinical study on safety and efficacy of Naesohwajung-tang on functional dyspepsia.,"BACKGROUND


Functional dyspepsia (FD) is a chronic gastrointestinal disorder diagnosed with dyspeptic symptoms, such as recurrent or persistent postprandial fullness, epigastric pain, burning, and early satiety without any evidence of structural abnormality. In traditional Korean medicine, herbal remedies are one of the preferred treatments for gastrointestinal symptoms. Among them, Naesohwajung-tang (NHT) has been frequently prescribed to improve dyspeptic symptoms for a long time. However, the safety and efficacy of NHT still remain unclear. Therefore, this study aims to evaluate the safety and efficacy of NHT in patients with FD using a randomized controlled trial.
METHODS


This is a protocol for a multi-center, randomized, double-blind, placebo-controlled trial. Total 116 participants aged between 19 and 75 years diagnosed with FD according to the Rome IV diagnosis criteria will be recruited at two Korean medicine hospitals. Eligible participants will be randomly assigned to either a NHT group or a placebo group in a 1:1 ratio. Each participant will be instructed to take NHT or placebo granules three times a day for 4 weeks. The primary outcome is the change in the total dyspepsia symptom score to confirm the efficacy of NHT. The secondary outcomes include overall total effect, single dyspepsia symptom scale, food retention questionnaire, Damum questionnaire, FD-related quality of life, electrogastrography, and safety assessments. Adverse events will be evaluated at every visit. The primary endpoint will be measured at week 4, and then re-evaluated at week 8 through a follow-up phone visit.
DISCUSSION


This trial will evaluate the safety and efficacy of NHT as a treatment of FD. The results of this trial will not only verify whether NHT improves FD symptoms and gastric myoelectrical activity, but also clarify those correlations.
TRIAL REGISTRATION NUMBER


CRIS KCT0003405.",2020,"The secondary outcomes include overall total effect, single dyspepsia symptom scale, food retention questionnaire, Damum questionnaire, FD-related quality of life, electrogastrography, and safety assessments.","['Eligible participants', 'Total 116 participants aged between 19 and 75 years diagnosed with FD according to the Rome IV diagnosis criteria will be recruited at two Korean medicine hospitals', 'patients with FD']","['NHT', 'Naesohwajung-tang', 'Naesohwajung-tang (NHT', 'NHT or placebo', 'placebo']","['total dyspepsia symptom score', 'efficacy of NHT', 'functional dyspepsia', 'dyspeptic symptoms', 'Adverse events', 'overall total effect, single dyspepsia symptom scale, food retention questionnaire, Damum questionnaire, FD-related quality of life, electrogastrography, and safety assessments', 'FD symptoms and gastric myoelectrical activity', 'safety and efficacy']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0430689', 'cui_str': 'Electromyography of stomach'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",116.0,0.659328,"The secondary outcomes include overall total effect, single dyspepsia symptom scale, food retention questionnaire, Damum questionnaire, FD-related quality of life, electrogastrography, and safety assessments.","[{'ForeName': 'Na-Yeon', 'Initials': 'NY', 'LastName': 'Ha', 'Affiliation': 'Department of Gastroenterology, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Seulki', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Gastroenterology, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Seok-Jae', 'Initials': 'SJ', 'LastName': 'Ko', 'Affiliation': 'Department of Gastroenterology, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Jae-Woo', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': 'Department of Gastroenterology, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Jinsung', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Gastroenterology, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.'}]",Medicine,['10.1097/MD.0000000000019910']
3249,32481364,"Study on efficacy and safety of Huangqi Guizhi Wuwu decoction treatment for oxaliplatin induced peripheral neurotoxicity: A protocol for a randomized, controlled, double-blind, multicenter trial.","BACKGROUND


Oxaliplatin can cause severe peripheral neurotoxicity, which is an important reason for clinical oxaliplatin reduction and cessation of treatment. Oxaliplatin induced peripheral neurotoxicity (OIPN) can cause paresthesia and dysesthesia, even affect the quality life of patients. So far, there are no recognized and effective measures to prevent OIPN. Huangqi Guizhi Wuwu decoction is a classical prescription of ancient Chinese medicine recorded in ""the synopsis of the Golden Chamber,"" which can be used in the treatment of various neurotoxicity. However, there is a lack of large-scale and high-quality clinical studies on the prevention of OIPN by Huangqi Guizhi Wuwu decoction. The purpose of this study is to evaluate the efficacy and safety of Huangqi Guizhi Wuwu decoction on preventing OIPN.
METHODS/DESIGN


This study is a randomized, controlled, double-blind, and multicenter clinical trial. Three hundred sixty patients will be randomly assigned into Huangqi Guizhi Wuwu decoction group and Huangqi Guizhi Wuwu decoction mimetic agent group. Patients will receive chemotherapy with FOLFOX of 8 cycles of 3 weeks with Traditional Chinese Medicine (TCM) for 6 months and 1-year follow-up. The primary outcome measure is the differences in the incidence of chronic neurotoxicity of grade 2 and above during and after treatment. The secondary outcome measure is the improvement in other symptoms associated with chemotherapy. Four methods will be used to evaluate the efficacy of neurotoxicity, including oxaliplatin specific toxicity grading standard (Levi classification); CTCAE4.02 version; EORTC QLQ-CIPN20 scale, EORTC QLQ C30 scale, and EORTC QLQ-CR29 scale are used at the same time; Electromyography.
DISCUSSION


This study will provide objective evidences to evaluate the efficacy and safety of Huangqi Guizhi Wuwu Decoction on preventing OIPN.
TRIAL REGISTRATION


Clinical Trials.gov (Identifier: NCT04261920).",2020,"Oxaliplatin induced peripheral neurotoxicity (OIPN) can cause paresthesia and dysesthesia, even affect the quality life of patients.",['Three hundred sixty patients'],"['oxaliplatin', 'Huangqi Guizhi Wuwu decoction', 'Wuwu decoction', 'Huangqi Guizhi Wuwu Decoction', 'Huangqi Guizhi', 'Oxaliplatin', 'Huangqi Guizhi Wuwu decoction group and Huangqi Guizhi Wuwu decoction mimetic agent group', 'Traditional Chinese Medicine (TCM', 'chemotherapy with FOLFOX']","['incidence of chronic neurotoxicity of grade 2 and above during and after treatment', 'peripheral neurotoxicity', 'efficacy and safety', 'peripheral neurotoxicity (OIPN', 'efficacy of neurotoxicity, including oxaliplatin specific toxicity grading standard (Levi classification); CTCAE4.02 version; EORTC QLQ-CIPN20 scale, EORTC QLQ C30 scale, and EORTC QLQ-CR29 scale']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0696679', 'cui_str': 'Astragalus propinquus root extract'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxicity'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",360.0,0.151994,"Oxaliplatin induced peripheral neurotoxicity (OIPN) can cause paresthesia and dysesthesia, even affect the quality life of patients.","[{'ForeName': 'Xiao-Man', 'Initials': 'XM', 'LastName': 'Wei', 'Affiliation': 'The First Clinical College of Nanjing University of Chinese Medicine.'}, {'ForeName': 'Xiao-Feng', 'Initials': 'XF', 'LastName': 'Chen', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital With Nanjing Medical University.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Shu', 'Affiliation': 'Department of Oncology, Affiliated Hospital of Nanjing University of Chinese Medicine.'}, {'ForeName': 'Zhi-Wei', 'Initials': 'ZW', 'LastName': 'Jiang', 'Affiliation': 'Department of General Surgery, Affiliated Hospital of Nanjing University of Chinese Medicine.'}, {'ForeName': 'Xiao-Yu', 'Initials': 'XY', 'LastName': 'Wu', 'Affiliation': 'Department of Surgical Oncology, Affiliated Hospital of Nanjing University of Chinese Medicine.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zou', 'Affiliation': 'Department of Oncology, Affiliated Hospital of Nanjing University of Chinese Medicine.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Soochow University, Suzhou.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Shen', 'Affiliation': 'Department of Oncology, Jiangsu Cancer Hospital.'}, {'ForeName': 'Wen-Wei', 'Initials': 'WW', 'LastName': 'Hu', 'Affiliation': 'Department of Oncology, The Third Affiliated Hospital of Soochow University, Changzhou.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'Department of Oncology, Affiliated Hospital of Nanjing University of Chinese Medicine.'}, {'ForeName': 'Wei-Xing', 'Initials': 'WX', 'LastName': 'Shen', 'Affiliation': 'The First Clinical College of Nanjing University of Chinese Medicine.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'The First Clinical College of Nanjing University of Chinese Medicine.'}, {'ForeName': 'Jun-Yi', 'Initials': 'JY', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, Affiliated Hospital of Nanjing University of Chinese Medicine.'}, {'ForeName': 'Feng-Jiao', 'Initials': 'FJ', 'LastName': 'Zhao', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital With Nanjing Medical University.'}, {'ForeName': 'Qing-Feng', 'Initials': 'QF', 'LastName': 'Yin', 'Affiliation': 'Jiangsu Famous Medical Technology Co., Ltd, Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Hai-Bo', 'Initials': 'HB', 'LastName': 'Cheng', 'Affiliation': 'The First Clinical College of Nanjing University of Chinese Medicine.'}, {'ForeName': 'Yan-Hong', 'Initials': 'YH', 'LastName': 'Gu', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital With Nanjing Medical University.'}]",Medicine,['10.1097/MD.0000000000019923']
3250,32481369,Proximal versus distal adductor canal blocks for total knee arthroplasty: A protocol for randomized controlled trial.,"BACKGROUND


Currently, there remains a paucity of literature about the efficiency of proximal adductor canal block (PACB) versus distal adductor canal block (DACB) for pain management after total knee arthroplasty (TKA). The purpose of this study is to perform a randomized controlled trial to compare the efficiency of PACB versus DACB for early postoperative pain treatment after TKA.
METHODS


This study is a 2-arm, parallel-group, randomized controlled trial that is conducted at a single university hospital in China. Subjects presenting for unilateral TKA are randomized in a 1:1 ratio to either a PACB or DACB group. The primary outcome of this noninferiority study is opioid consumption within the first 24 hours following surgery. Secondary outcomes include quadriceps strength, pain scores, distance ambulated, and patient satisfaction. Continuous variables are compared using Student t test.
RESULTS


This clinical trial is expected to provide evidence of whether the PACB and DACB provide similar analgesia after TKA.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5440).",2020,Subjects presenting for unilateral TKA are randomized in a 1:1 ratio to either a PACB or DACB group.,"['total knee arthroplasty', 'pain management after total knee arthroplasty (TKA', 'Subjects presenting for unilateral TKA', 'single university hospital in China', 'early postoperative pain treatment after TKA']","['PACB or DACB', 'PACB versus DACB', 'proximal adductor canal block (PACB) versus distal adductor canal block (DACB', 'Proximal versus distal adductor canal blocks']","['opioid consumption within the first 24\u200ahours following surgery', 'quadriceps strength, pain scores, distance ambulated, and patient satisfaction']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}]","[{'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205108', 'cui_str': 'Distal'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",,0.340156,Subjects presenting for unilateral TKA are randomized in a 1:1 ratio to either a PACB or DACB group.,"[{'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Yijun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Jingyu', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': ''}, {'ForeName': 'Xiangjin', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000019995']
3251,32481374,"The ""Warrior"" system: a new useful emergency simulator to train clinical pharmacists in emergency medicine.","Clinical pharmacists are indispensable providers of emergency medical services. However, the training of Chinese clinical pharmacists in medical emergency skills is apparently insufficient.The current study aimed to evaluate the effect of the ""Warrior"" emergency simulator application in the emergency medical education of clinical pharmacy students (CP students).The ""Warrior"" system, which contains a pharmacokinetics/pharmacodynamics-linked model and a drug database, was successfully employed to train CP students and improve their capability to deal with various medical emergency situations. Both an objective (in-class) test and the subjective Dundee Ready Education Environment Measure (DREEM) were administered to 20 CP students, randomly divided into an intervention group and a control group, to estimate the teaching effect of the ""Warrior"" system.The scores of CP students from the intervention group were significantly higher (P < .01) in the in-class test than the scores of students from the control group due to the diverse situational teaching using the ""Warrior"" system. The results of the DREEM showed that CP students from the intervention group obtained considerably better (P < .01) marks for ""students' perceptions of learning"" and ""students' perceptions of atmosphere"" than those from the control group. Furthermore, the intervention group scored much higher (P < .01) than the control group on the total DREEM.The ""Warrior"" system provides an excellent training path for clinical pharmacists that supplies a more realistic clinical simulation experience and significantly improves the teaching effect. The ""Warrior"" system exhibits high potential for future development in emergency medical education.",2020,"The scores of CP students from the intervention group were significantly higher (P < .01) in the in-class test than the scores of students from the control group due to the diverse situational teaching using the ""Warrior"" system.",['20 CP students'],"['Warrior"" emergency simulator application']",['scores of CP students'],"[{'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",,0.0135149,"The scores of CP students from the intervention group were significantly higher (P < .01) in the in-class test than the scores of students from the control group due to the diverse situational teaching using the ""Warrior"" system.","[{'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Basic Medical College, Guizhou University of Traditional Chinese Medicine, Guiyang.'}, {'ForeName': 'Yang-Yang', 'Initials': 'YY', 'LastName': 'Wang', 'Affiliation': 'School of Chinese Materia Medica, Tianjin University of Traditional Chinese Medicine.'}, {'ForeName': 'Jing-Jie', 'Initials': 'JJ', 'LastName': 'Zhou', 'Affiliation': 'Tellyes Scientific Inc.'}, {'ForeName': 'Yan-Fei', 'Initials': 'YF', 'LastName': 'Liu', 'Affiliation': 'Tellyes Scientific Inc.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'School of Traditional Chinese Medicine, Guangdong Pharmaceutical University, Guangzhou, China.'}]",Medicine,['10.1097/MD.0000000000020047']
3252,32490976,Baerveldt implant versus trabeculectomy as the first filtering surgery for uncontrolled primary congenital glaucoma: a randomized clinical trial.,"PURPOSE


Our initial goal was to compare the efficacy and safety of a glaucoma drainage device and trabeculectomy for children with primary congenital glaucoma after angular surgery failure. However, we discontinued the study due to the rate of complications and wrote this report to describe the results obtained with the two techniques in this particular group.
METHODS


This was a parallel, non-masked, controlled trial that included patients aged 0-13 years who had undergone previous trabeculotomy or goniotomy and presented inadequately controlled glaucoma with an intraocular pressure ≥21 mmHg on maximum tolerated medical therapy. We randomized the patients to undergo either placement of a 250-mm2 Baerveldt glaucoma implant or mitomycin-augmented trabeculectomy. The main outcome measure was intraocular pressure control. We calculated complete success (without hypotensive ocular medication) and qualified success (with medication) rates. We defined failure as uncontrolled intraocular pressure, presence of serious complications, abnormal increase in ocular dimensions, or confirmed visual acuity decrease.
RESULTS


We studied 13 eyes of 13 children (five in the glaucoma drainage device group; eight in the trabeculectomy group). Both surgical procedures produced a significant intraocular pressure reduction 12 months after intervention from the baseline (tube group, 22.8 ± 5.9 mmHg to 12.20 ± 4.14 mmHg, p=0.0113; trabeculectomy group, 23.7 ± 7.3 mmHg to 15.6 ± 5.9 mmHg, p=0.0297). None of the patients in the tube group and 37.5% of those in the trabeculectomy group achieved complete success in intraocular pressure control after 12 months of follow-up (p=0.928, Chi-square test). Two patients (40%) had serious complications at the time of tube aperture (implant extrusion, retinal detachment).
CONCLUSIONS


Both the tube and trabeculectomy groups presented similar intraocular pressure controls, but complete success was more frequent in the trabeculectomy group. Non-valved glaucoma drainage devices caused potentially blinding complications during tube opening. Because of the small sample size, we could not draw conclusions as to the safety data of the studied technique.",2020,"Both surgical procedures produced a significant intraocular pressure reduction 12 months after intervention from the baseline (tube group, 22.8 ± 5.9 mmHg to 12.20 ± 4.14 mmHg, p=0.0113; trabeculectomy group, 23.7 ± 7.3 mmHg to 15.6 ± 5.9 mmHg, p=0.0297).","['children with primary congenital glaucoma after angular surgery failure', '13 eyes of 13 children (five in the glaucoma drainage device group; eight in the trabeculectomy group', 'uncontrolled primary congenital glaucoma', 'patients aged 0-13 years who had undergone previous trabeculotomy or goniotomy and presented inadequately controlled glaucoma with an intraocular pressure ≥21 mmHg on maximum tolerated medical therapy']","['Baerveldt implant versus trabeculectomy', 'trabeculectomy', '250-mm2 Baerveldt glaucoma implant or mitomycin-augmented trabeculectomy', 'glaucoma drainage device and trabeculectomy']","['serious complications', 'intraocular pressure controls', 'complete success in intraocular pressure control', 'intraocular pressure reduction', 'efficacy and safety', 'complete success', 'ocular dimensions, or confirmed visual acuity decrease', 'intraocular pressure control']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1533041', 'cui_str': 'Primary congenital glaucoma'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0181041', 'cui_str': 'Glaucoma drainage device'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0040576', 'cui_str': 'Trabeculotomy'}, {'cui': 'C0018072', 'cui_str': 'Goniotomy'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}]","[{'cui': 'C0600545', 'cui_str': 'Baerveldt Implants'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0456786', 'cui_str': 'sq. mm'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0181041', 'cui_str': 'Glaucoma drainage device'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0234632', 'cui_str': 'Reduced visual acuity'}]",13.0,0.099004,"Both surgical procedures produced a significant intraocular pressure reduction 12 months after intervention from the baseline (tube group, 22.8 ± 5.9 mmHg to 12.20 ± 4.14 mmHg, p=0.0113; trabeculectomy group, 23.7 ± 7.3 mmHg to 15.6 ± 5.9 mmHg, p=0.0297).","[{'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Rolim-de-Moura', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Bruno L B', 'Initials': 'BLB', 'LastName': 'Esporcatte', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'F Netto', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Paranhos', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}]",Arquivos brasileiros de oftalmologia,['10.5935/0004-2749.20200060']
3253,32491006,Controlled Study of Central Hemodynamic Changes in Inspiratory Exercise with Different Loads in Heart Failure.,"Background Inspiratory muscle weakness contributes to exercise intolerance and decreased quality of life in patients with heart failure. Studies with inspiratory muscle training show improvement in inspiratory muscle strength, functional capacity and quality of life. However, little is known about the central hemodynamic response (CHR) during inspiratory exercise (IE). Objective To evaluate CHR in a single IE session with different loads (placebo, 30% and 60%) in heart failure. Methods Randomized placebo-controlled clinical trial in patients with heart failure with reduced ejection fraction, functional class II and III. Twenty patients aged 65 ± 11 years completed a single session of inspiratory exercise, in 3 cycles of 15 minutes, with a 1-hour washout, involving loads of 30% (C30), 60% (C60) and placebo, using a linear load resistor (PowerBreathe Light). The noninvasive hemodynamic study was performed by cardiothoracic bioimpedance (Niccomo™ CardioScreen®). Statistical analysis was performed with Student's t-test and Pearson's correlation, and P≤0.05 was considered significant. Results An increase in heart rate (HR) was observed with C30 (64 ± 15 vs 69 ± 15 bpm; p = 0.005) and C60 (67 ± 14 vs 73 ± 14 bpm, p = 0.002). A decrease was observed in systolic volume (SV) with C30 (73 ± 26 vs 64 ± 20 ml; p = 0.004). Cardiac output (CO), on its turn, increased only with C60 (4.6 ± 1.5 vs 5.3 ± 1.7 l/min; p = -0.001). Conclusion When using the 60% load, in a single IE session, changes in CHR were observed. HR and CD increased, as did the Borg scales and subjective sensation of dyspnea. The 30% load reduced the SV. (Arq Bras Cardiol. 2020; 114(4):656-663).",2020,"HR and CD increased, as did the Borg scales and subjective sensation of dyspnea.","['patients with heart failure with reduced ejection fraction, functional class II and III', 'patients with heart failure', 'Twenty patients aged 65 ± 11 years completed a', 'Inspiratory Exercise with Different Loads in Heart Failure']","['placebo', 'single session of inspiratory exercise', 'inspiratory muscle training']","['quality of life', 'CHR', 'inspiratory muscle strength, functional capacity and quality of life', 'systolic volume (SV', 'HR and CD', 'heart failure', 'heart rate (HR', 'SV', 'subjective sensation of dyspnea', 'Cardiac output (CO']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}]",,0.0580409,"HR and CD increased, as did the Borg scales and subjective sensation of dyspnea.","[{'ForeName': 'Luana de Decco', 'Initials': 'LD', 'LastName': 'Marchese', 'Affiliation': 'Universidade Federal Fluminense, Niterói, RJ, Brasil.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Chermont', 'Affiliation': 'Universidade Federal Fluminense, Niterói, RJ, Brasil.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Warol', 'Affiliation': 'Universidade Federal Fluminense, Niterói, RJ, Brasil.'}, {'ForeName': 'Lucia Brandão de', 'Initials': 'LB', 'LastName': 'Oliveira', 'Affiliation': 'Clínica de Insuficiência Cardíaca, Centro Universitário Serra dos Órgãos, Teresópolis, RJ, Brasil.'}, {'ForeName': 'Sabrina Bernardez', 'Initials': 'SB', 'LastName': 'Pereira', 'Affiliation': 'Hospital do Coração, São Paulo, SP – Brazil'}, {'ForeName': 'Mônica', 'Initials': 'M', 'LastName': 'Quintão', 'Affiliation': 'Universidade Federal Fluminense, Niterói, RJ, Brasil.'}, {'ForeName': 'Evandro Tinoco', 'Initials': 'ET', 'LastName': 'Mesquita', 'Affiliation': 'Universidade Federal Fluminense, Niterói, RJ, Brasil.'}]",Arquivos brasileiros de cardiologia,['10.36660/abc.20180375']
3254,32491082,Theory-based training to promote breast cancer screening among women with breast cancer worries: randomized controlled trial.,"BACKGROUND


Breast cancer worries are important determinants in relation to behavior favoring breast cancer screening.
OBJECTIVE


To determine the effect of theory-based training to promote breast cancer screening among women with high and low levels of breast cancer worries.
DESIGN AND SETTING


Randomized controlled trial, conducted in two family health centers.
METHODS


In total, 285 women were recruited. Women with low levels of breast cancer worries were included in the first intervention group (112 women) and the first control group (112 women), while women with high levels of breast cancer worries were included in the second intervention group (37 women) and the second control group (43 women). Theory-based training to promote breast cancer screening was given to intervention groups. The women's willingness to undergo breast cancer screening and breast cancer worry scores were evaluated at 1, 3 and 6 months.
RESULTS


The women in the low cancer-worry intervention group performed breast self-examination more in months 1 and 6 following the training, and the women in the high cancer-worry control group performed breast self-examination more in month 3 (P < 0.05). No difference between the women who had low or high levels of breast cancer worries were observed in relation to breast self-examination, clinical breast examination or mammography (P > 0.05).
CONCLUSION


The level of worry did not affect the success of theory-based training, and the training was partially effective with regard to willingness to undergo breast cancer screening.",2020,"No difference between the women who had low or high levels of breast cancer worries were observed in relation to breast self-examination, clinical breast examination or mammography (P > 0.05).
","['285 women were recruited', 'women with breast cancer worries', 'Women with low levels of breast cancer worries were included in the first intervention group (112 women) and the first control group (112 women), while women with high levels of breast cancer worries were included in the second intervention group (37 women) and the second control group (43 women', 'women with high and low levels of breast cancer worries', 'two family health centers']","['Theory-based training to promote breast cancer screening', 'theory-based training']","['breast self-examination', ""women's willingness to undergo breast cancer screening and breast cancer worry scores"", 'breast cancer worries']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0600220', 'cui_str': 'Family health status'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0281182', 'cui_str': 'Screening for malignant neoplasm of breast'}]","[{'cui': 'C0085105', 'cui_str': 'Breast self-examination'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0281182', 'cui_str': 'Screening for malignant neoplasm of breast'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",285.0,0.0222049,"No difference between the women who had low or high levels of breast cancer worries were observed in relation to breast self-examination, clinical breast examination or mammography (P > 0.05).
","[{'ForeName': 'Sermin Timur', 'Initials': 'ST', 'LastName': 'Taşhan', 'Affiliation': ""Department of Birth, Women's Health and Illness, Faculty of Nursing, Inönü Üniversitesi, Malatya, Turkey.""}, {'ForeName': 'Yeşim Aksoy', 'Initials': 'YA', 'LastName': 'Derya', 'Affiliation': 'Department of Midwifery, Faculty of Health Sciences, Inönü Üniversitesi, Malatya, Turkey.'}, {'ForeName': 'Tuba', 'Initials': 'T', 'LastName': 'Uçar', 'Affiliation': 'Department of Midwifery, Faculty of Health Sciences, Inönü Üniversitesi, Malatya, Turkey.'}, {'ForeName': 'Gülçin', 'Initials': 'G', 'LastName': 'Nacar', 'Affiliation': ""Department of Birth, Women's Health and Illness, Faculty of Nursing, Inönü Üniversitesi, Malatya, Turkey.""}, {'ForeName': 'Behice', 'Initials': 'B', 'LastName': 'Erci', 'Affiliation': 'Department of Public Health, Faculty of Nursing, Inönü Üniversitesi, Malatya, Turkey.'}]",Sao Paulo medical journal = Revista paulista de medicina,['10.1590/1516-3180.2019.033430092019']
3255,32487507,Reducing the Number of Opioids Consumed After Discharge Following Elective Cesarean Delivery: A Randomized Controlled Trial.,"OBJECTIVE


To reduce opioids consumed after discharge from hospital after elective cesarean delivery by 50%.
METHODS


This was a two-week parallel group non-blinded randomized controlled trial at Mount Sinai Hospital. Eligible women undergoing elective cesarean delivery were assigned by random number generation to receive the hospital's standard post-cesarean opioid prescription of 20 1-mg hydromorphone tablets or a prescription for 10 1-mg hydromorphone tablets if opioids were required in hospital or no hydromorphone if no opioids were required in hospital. Patients completed a study questionnaire at two weeks postpartum detailing outcome measures. The primary outcome was the amount of opioid consumed after discharge.
RESULTS


A total of 40 women were randomly assigned to a study group and 37 were included in the data analysis; 17 patients were in the control group and 20 in the experimental group. The median number of tablets consumed did not differ between groups (P = 0.407). The median number of excess tablets prescribed was 20 (range 2-18) in the control group and 0 (range 0-10) in the experimental group (P < 0.001).
CONCLUSIONS


The current standard discharge practice of giving 20 1-mg hydromorphone tablets to all patients post-discharge after cesarean delivery contributes to a substantial excess of opioids in the community. These opioids can be diverted for unintended or accidental usage, and exacerbate larger societal issues of opioid misuse and addiction. Decreasing the number of opioids prescribed with tailored discharge prescriptions based on in-hospital opioid use provides nearly all patients with adequate pain control.",2020,The median number of tablets consumed did not differ between groups (P = 0.407).,"['Eligible women undergoing elective cesarean delivery', 'A total of 40 women were randomly assigned to a study group and 37 were included in the data analysis; 17 patients were in the control group and 20 in the experimental group']","['hydromorphone tablets if opioids were required in hospital or no hydromorphone if no opioids', 'hydromorphone tablets']","['median number of excess tablets', 'median number of tablets', 'amount of opioid consumed after discharge', 'Number of Opioids Consumed']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",40.0,0.373934,The median number of tablets consumed did not differ between groups (P = 0.407).,"[{'ForeName': 'Shira', 'Initials': 'S', 'LastName': 'Gold', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Toronto, Toronto, ON.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Figueiro-Filho', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Toronto, Toronto, ON; Mount Sinai Hospital, Department of Obstetrics and Gynecology, Toronto, ON.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Toronto, Toronto, ON; Mount Sinai Hospital, Department of Obstetrics and Gynecology, Toronto, ON.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Selk', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Toronto, Toronto, ON; Mount Sinai Hospital, Department of Obstetrics and Gynecology, Toronto, ON. Electronic address: amanda.selk@utoronto.ca.'}]",Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC,['10.1016/j.jogc.2020.02.123']
3256,32490570,Safety and Feasibility of Additional Tumor Debulking to First-Line Palliative Combination Chemotherapy for Patients with Multiorgan Metastatic Colorectal Cancer.,"INTRODUCTION


Local treatment of metastases is frequently performed in patients with multiorgan metastatic colorectal carcinoma (mCRC) analogous to selected patients with oligometastatic disease for whom this is standard of care. The ORCHESTRA trial (NCT01792934) was designed to prospectively evaluate overall survival benefit from tumor debulking in addition to chemotherapy in patients with multiorgan mCRC. Here, we report the preplanned safety and feasibility evaluation after inclusion of the first 100 patients.
METHODS


Patients were eligible if at least 80% tumor debulking was deemed feasible by resection, radiotherapy and/or thermal ablative therapy. In case of clinical benefit after three or four cycles of respectively 5-fluorouracil/leucovorin or capecitabine and oxaliplatin ± bevacizumab patients were randomized to tumor debulking followed by chemotherapy in the intervention arm, or standard treatment with chemotherapy.
RESULTS


Twelve patients dropped out prior to randomization for various reasons. Eighty-eight patients were randomized to the standard (n = 43) or intervention arm (n = 45). No patients withdrew after randomization. Debulking was performed in 82% (n = 37). Two patients had no lesions left to treat, five had progressive disease, and one patient died prior to local treatment. In 15 patients (40%) 21 serious adverse events related to debulking were reported. Postoperative mortality was 2.7% (n = 1). After debulking chemotherapy was resumed in 89% of patients.
CONCLUSION


Tumor debulking is feasible and does not prohibit administration of palliative chemotherapy in the majority of patients with multiorgan mCRC, despite the occurrence of serious adverse events related to local treatment.
IMPLICATIONS FOR PRACTICE


This first prospective randomized trial on tumor debulking in addition to chemotherapy shows that local treatment of metastases is feasible in patients with multiorgan metastatic colorectal cancer and does not prohibit administration of palliative systemic therapy, despite the occurrence of serious adverse events related to local treatment. The trial continues accrual, and overall survival (OS) data and quality of life assessment are collected to determine whether the primary aim of >6 months OS benefit with preserved quality of life will be met. This will support evidence-based decision making in multidisciplinary colorectal cancer care and can be readily implemented in daily practice.",2020,"shows that local treatment of metastases is feasible in patients with multiorgan metastatic colorectal cancer and does not prohibit administration of palliative systemic therapy, despite the occurrence of serious adverse events related to local treatment.","['patients with multiorgan metastatic colorectal cancer', 'Patients were eligible if at least 80% tumor debulking was deemed feasible by resection', 'patients with multiorgan mCRC', '100 patients', 'Eighty-eight patients', 'patients with multiorgan metastatic colorectal carcinoma (mCRC', 'Patients with Multiorgan Metastatic Colorectal Cancer']","['chemotherapy', 'radiotherapy and/or thermal ablative therapy', 'Additional Tumor Debulking to First-Line Palliative Combination Chemotherapy', '5-fluorouracil/leucovorin or capecitabine and oxaliplatin ± bevacizumab']","['overall survival (OS) data and quality of life assessment', 'Postoperative mortality', 'overall survival benefit']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517898', 'cui_str': '88'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",88.0,0.0760622,"shows that local treatment of metastases is feasible in patients with multiorgan metastatic colorectal cancer and does not prohibit administration of palliative systemic therapy, despite the occurrence of serious adverse events related to local treatment.","[{'ForeName': 'Elske C', 'Initials': 'EC', 'LastName': 'Gootjes', 'Affiliation': 'Department of Medical Oncology, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'van der Stok', 'Affiliation': 'Department of Surgery, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Tineke E', 'Initials': 'TE', 'LastName': 'Buffart', 'Affiliation': 'Department of Medical Oncology, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'Bakkerus', 'Affiliation': 'Department of Medical Oncology, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Mariette', 'Initials': 'M', 'LastName': 'Labots', 'Affiliation': 'Department of Medical Oncology, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Barbara M', 'Initials': 'BM', 'LastName': 'Zonderhuis', 'Affiliation': 'Department of Surgery, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Jurriaan B', 'Initials': 'JB', 'LastName': 'Tuynman', 'Affiliation': 'Department of Surgery, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Martijn R', 'Initials': 'MR', 'LastName': 'Meijerink', 'Affiliation': 'Department of Radiology and Nuclear Medicine, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'van de Ven', 'Affiliation': 'Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Cornelis J A', 'Initials': 'CJA', 'LastName': 'Haasbeek', 'Affiliation': 'Department of Radiotherapy, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Albert J', 'Initials': 'AJ', 'LastName': 'Ten Tije', 'Affiliation': 'Department of Medical Oncology, Amphia Hospital, Breda, The Netherlands.'}, {'ForeName': 'Jan-Willem B', 'Initials': 'JB', 'LastName': 'de Groot', 'Affiliation': 'Department of Medical Oncology, Isala, The Netherlands.'}, {'ForeName': 'Mathijs P', 'Initials': 'MP', 'LastName': 'Hendriks', 'Affiliation': 'Department of Medical Oncology, Northwest Clinics, Alkmaar, The Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'van Meerten', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Joost J M E', 'Initials': 'JJME', 'LastName': 'Nuyttens', 'Affiliation': 'Department of Radiotherapy, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'Grunhagen', 'Affiliation': 'Department of Surgery, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Cornelis', 'Initials': 'C', 'LastName': 'Verhoef', 'Affiliation': 'Department of Surgery, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Henk M W', 'Initials': 'HMW', 'LastName': 'Verheul', 'Affiliation': 'Department of Medical Oncology, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The oncologist,['10.1634/theoncologist.2019-0693']
3257,32489146,ΔKi67 proliferation index as independent predictive and prognostic factor of outcome in luminal breast cancer: data from neoadjuvant letrozole-based treatment.,"A key tool for monitoring breast cancer patients under neoadjuvant treatment is the identification of reliable predictive markers. Ki67 has been identified as a prognostic and predictive marker in ER-positive breast cancer. Ninety ER-positive, HER2 negative locally advanced breast cancer patients received letrozole (2.5 mg daily) and cyclophosphamide (50 mg daily) with/without Sorafenib (400 mg/bid daily) for 6 months before undergoing surgery. Ki67 expression and tumor size measured with caliber were determined at baseline, after 30 days of treatment and at the end of treatment. Patients were assigned to a clinical response category according to Response Evaluation Criteria in Solid Tumors, both at 30 days and before surgery and further classified as high-responder and low-responder according to the median variation of Ki67 values between biopsy and 30 days and between biopsy and surgery time. The predictive role of Ki67 and its changes with regard to clinical response and survival was analyzed. No differences in terms of survival outcomes emerged between the arms of treatment, while we observed a higher percentage of women with progression or stable disease in arm with the combination containing Sorafenib (20.5% vs 7.1%,  p  = 0.06). Clinical complete responders experienced a greater overall variation in Ki67 when compared with partial responders and patients with progressive/stable disease (66.7% vs 30.7%,  p  = 0.009). High responders showed a better outcome than low responders in terms of both disease-free survival ( p  = 0.009) and overall survival ( p  = 0.002). ΔKi67 score evaluated between basal and residual tumor at definitive surgery showed to be highly predictive of clinical complete response, and a potential parameter to be used for predicting disease-free survival and overall survival in luminal breast cancer treated with neoadjuvant endocrine-based therapy.",2020,"Clinical complete responders experienced a greater overall variation in Ki67 when compared with partial responders and patients with progressive/stable disease (66.7% vs 30.7%,  p  = 0.009).","['luminal breast cancer', 'Ninety ER-positive, HER2 negative locally advanced breast cancer patients', 'monitoring breast cancer patients under']","['letrozole', 'cyclophosphamide', 'Sorafenib', 'neoadjuvant treatment']","['women with progression or stable disease', 'Ki67 expression and tumor size measured with caliber', 'overall survival', 'disease-free survival', 'survival outcomes']","[{'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0279754', 'cui_str': 'ESR1 positive'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C3495949', 'cui_str': 'Locally advanced breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0991705,"Clinical complete responders experienced a greater overall variation in Ki67 when compared with partial responders and patients with progressive/stable disease (66.7% vs 30.7%,  p  = 0.009).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ianza', 'Affiliation': 'Department of Medical, Surgery & Health Sciences, University of Trieste, Trieste, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Giudici', 'Affiliation': 'Department of Medical, Surgical & Health Sciences, Cattinara Teaching Hospital, University of Trieste, Trieste, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Pinello', 'Affiliation': 'Department of Medical, Surgical & Health Sciences, Cattinara Teaching Hospital, University of Trieste, Trieste, Italy.'}, {'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Corona', 'Affiliation': 'Department of Medical, Surgical & Health Sciences, Cattinara Teaching Hospital, University of Trieste, Trieste, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Strina', 'Affiliation': 'Breast Cancer Unit and Translational Research Unit, ASST Cremona, Cremona, Italy.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Bernocchi', 'Affiliation': 'Department of Medical, Surgical & Health Sciences, Cattinara Teaching Hospital, University of Trieste, Trieste, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bortul', 'Affiliation': 'Department of Medical, Surgical & Health Sciences, Cattinara Teaching Hospital, University of Trieste, Trieste, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Milani', 'Affiliation': 'Breast Cancer Unit and Translational Research Unit, ASST Cremona, Cremona, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sirico', 'Affiliation': 'Breast Cancer Unit and Translational Research Unit, ASST Cremona, Cremona, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Allevi', 'Affiliation': 'Breast Cancer Unit and Translational Research Unit, ASST Cremona, Cremona, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Aguggini', 'Affiliation': 'Breast Cancer Unit and Translational Research Unit, ASST Cremona, Cremona, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cocconi', 'Affiliation': 'Breast Cancer Unit and Translational Research Unit, ASST Cremona, Cremona, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Azzini', 'Affiliation': 'Breast Cancer Unit and Translational Research Unit, ASST Cremona, Cremona, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dester', 'Affiliation': 'Breast Cancer Unit and Translational Research Unit, ASST Cremona, Cremona, Italy.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Cervoni', 'Affiliation': 'Breast Cancer Unit and Translational Research Unit, ASST Cremona, Cremona, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bottini', 'Affiliation': 'Breast Cancer Unit and Translational Research Unit, ASST Cremona, Cremona, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cappelletti', 'Affiliation': 'Breast Cancer Unit and Translational Research Unit, ASST Cremona, Cremona, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Generali', 'Affiliation': 'Department of Medical, Surgical & Health Sciences, Cattinara Teaching Hospital, University of Trieste, Trieste, Italy.'}]",Tumour biology : the journal of the International Society for Oncodevelopmental Biology and Medicine,['10.1177/1010428320925301']
3258,32485124,"Effects of a single dose of vitamin D in septic children: a randomized, double-blinded, controlled trial.","OBJECTIVE


To assess the effects of a single dose of vitamin D on 25-hydroxyvitamin D (25OHD) levels and clinical outcomes in children with vitamin D deficiency (VDD) and sepsis.
METHODS


In this randomized, controlled trial, eligible children with VDD and sepsis were assigned to receive one dose of 150,000 IU of cholecalciferol or placebo. Serum concentrations of 25OHD, angiotensin-II (Ang-II), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α) were assessed at baseline and 8 days after treatment. The cardiovascular Sequential Organ Failure Assessment (cv-SOFA) score, septic shock incidence, duration of ventilation, and mortality were also examined.
RESULTS


One hundred nine participants fulfilled the study requirements. The two groups had comparable baseline characteristics. Ang-II, IL-6, and TNF-α concentrations were all reduced after vitamin D supplementation. Furthermore, the cv-SOFA score (1.76 ± 0.8 vs. 2.3 ± 1.1) and incidence of septic shock (7% vs. 20%) were lower in the treatment group than in the control group. The duration of ventilation and mortality rates did not differ between two groups.
CONCLUSIONS


A single dose of vitamin D improved 25OHD levels and the incidence of septic shock in children with VDD and sepsis.",2020,A single dose of vitamin D improved 25OHD levels and the incidence of septic shock in children with VDD and sepsis.,"['children with VDD and sepsis', 'eligible children with VDD and sepsis', 'septic children', 'children with vitamin D deficiency (VDD) and sepsis', 'One hundred nine participants fulfilled the study requirements']","['cholecalciferol or placebo', 'vitamin D']","['incidence of septic shock', 'Ang-II, IL-6, and TNF-α concentrations', 'duration of ventilation and mortality rates', '25OHD levels', 'Serum concentrations of 25OHD, angiotensin-II (Ang-II), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α', '25-hydroxyvitamin D (25OHD) levels and clinical outcomes', 'cardiovascular Sequential Organ Failure Assessment (cv-SOFA) score, septic shock incidence, duration of ventilation, and mortality', 'cv-SOFA score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0003009', 'cui_str': 'angiotensin II'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}]",,0.753691,A single dose of vitamin D improved 25OHD levels and the incidence of septic shock in children with VDD and sepsis.,"[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Pediatrics, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan, China.""}, {'ForeName': 'Zhongwen', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': ""Department of Pediatrics, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': ""Department of Pediatrics, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan, China.""}, {'ForeName': 'Zhenfeng', 'Initials': 'Z', 'LastName': 'Cao', 'Affiliation': ""Department of Pediatrics, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan, China.""}, {'ForeName': 'Qianhan', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Department of Pediatrics, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan, China.""}]",The Journal of international medical research,['10.1177/0300060520926890']
3259,32485641,"Caloric restriction, resting metabolic rate and cognitive performance in Non-obese adults: A post-hoc analysis from CALERIE study.","Physical activity (PA) has been proposed as a determinant of cognitive function and is one component of energy balance (EB). EB is the difference between energy intake (EI) and the total daily energy expenditure (TDEE). TDEE is a combination of resting metabolic rate (RMR), thermic effect of food and PA. The potential role of each of these components on cognitive function has not yet been systemically investigated. We aim to evaluate the association between each component of EB on cognition, using baseline and longitudinal data from a clinical trial of caloric restriction (CR). This is a parallel-group, randomized clinical trial comparing two years of 25% CR with two years of ad libitum diet (AL), with 220 healthy volunteers of both sex, aged between 21 and 50 years and initial BMI ≥ 22 kg/m2 and <28 kg/m2. Body weight, fat mass (FM), fat-free mass (FFM), and bone mineral content were evaluated, as well as RMR, TDEE, cognitive performance and baseline energy intake. A 30 min/day of a moderate level on a minimum of 5 days/week was advised as PA measure. Longitudinal analysis demonstrated that the influence of CR in the improvement of cognitive performance was moderated by changes in RMR, suggesting that in individuals submitted to CR, the cognitive performance and the RMR improved proportionally, independently of changes in EI and body mass. EB and homeostasis are crucial to modulate the RMR. Moreover, RMR presents an important influence on cognitive function in individuals submitted to CR in a long term.",2020,"Longitudinal analysis demonstrated that the influence of CR in the improvement of cognitive performance was moderated by changes in RMR, suggesting that in individuals submitted to CR, the cognitive performance and the RMR improved proportionally, independently of changes in EI and body mass.","['two years of 25% CR with two years of ad libitum diet (AL), with 220 healthy volunteers of both sex, aged between 21 and 50 years and initial BMI', 'Non-obese adults']","['TDEE', 'Physical activity (PA', 'caloric restriction (CR']","['cognitive performance', 'RMR, TDEE, cognitive performance and baseline energy intake', 'total daily energy expenditure (TDEE', 'cognitive function', 'resting metabolic rate (RMR), thermic effect of food and PA', 'Body weight, fat mass (FM), fat-free mass (FFM), and bone mineral content', 'cognitive performance and the RMR', 'Caloric restriction, resting metabolic rate and cognitive performance']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}]","[{'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}]",220.0,0.044031,"Longitudinal analysis demonstrated that the influence of CR in the improvement of cognitive performance was moderated by changes in RMR, suggesting that in individuals submitted to CR, the cognitive performance and the RMR improved proportionally, independently of changes in EI and body mass.","[{'ForeName': 'Ruth Bartelli', 'Initials': 'RB', 'LastName': 'Grigolon', 'Affiliation': 'Post-Graduation Program in Psychiatry, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Brietzke', 'Affiliation': ""Post-Graduation Program in Psychiatry, Universidade Federal de São Paulo, São Paulo, SP, Brazil; Department of Psychiatry, Queen's University School of Medicine, Kingston, ON, Canada; Centre for Neuroscience Studies (CNS), Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Alisson Paulino', 'Initials': 'AP', 'LastName': 'Trevizol', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention and Campbell Family Research Institute, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Roger S', 'Initials': 'RS', 'LastName': 'McIntyre', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, Toronto Western Hospital, University Health Network, Toronto, ON, Canada; University of Toronto, Toronto, ON, Canada; Brain and Cognition Foundation, Toronto, ON, Canada.'}, {'ForeName': 'Rodrigo B', 'Initials': 'RB', 'LastName': 'Mansur', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, Toronto Western Hospital, University Health Network, Toronto, ON, Canada; University of Toronto, Toronto, ON, Canada. Electronic address: rodrigomansur71@uol.com.br.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.05.018']
3260,32485656,Impulsiveness as a moderator of amphetamine treatment response for cocaine use disorder among ADHD patients.,"BACKGROUND


Amphetamines are a first-line treatment for ADHD and have shown promise for the treatment of cocaine use disorder (CUD), both alone and with comorbid ADHD. Impulsiveness is a key aspect of both ADHD and substance use disorders. We sought to understand the role of baseline impulsiveness in the treatment of comorbid CUD and ADHD.
METHODS


In a post hoc analysis (N = 76) of a 14-week, double-blind, randomized, placebo-controlled trial of mixed amphetamine salts-extended release (MAS-ER) for comorbid ADHD and CUD, we examined the relationship between treatment response and participants' baseline Barratt Impulsiveness Scale (BIS-11) score by comparing those with scores below versus above the median. In the original trial, participants received daily 60 mg MAS-ER, 80 mg MAS-ER, or placebo, in conjunction with cognitive behavioral therapy.
RESULTS


The odds of a cocaine-abstinent week over time were significantly greater in the high BIS group compared to the low BIS group, both when missing data was treated as missing (p = .0155; OR = 1.23, 95% CI: 1.13, 1.35 versus OR = 1.04, 95% CI: 0.95, 1.15) and when missing data was treated as cocaine-positive (p = .003; OR = 1.15, 95% CI: 1.06, 1.24 versus OR = 0.96, 95% CI: 0.88, 1.05).
CONCLUSIONS


The results show an association between higher within-group trait impulsiveness, as measured by the BIS-11, and response to MAS-ER for CUD in a cohort with comorbid ADHD. This result further demonstrates that impulsiveness is an important factor when considering treatment options for patients with CUD and that higher baseline impulsiveness may predict response to treatment with psychostimulants for CUD.",2020,"The odds of a cocaine-abstinent week over time were significantly greater in the high BIS group compared to the low BIS group, both when missing data was treated as missing (p = .0155; OR = 1.23, 95% CI: 1.13, 1.35 versus OR = 1.04, 95% CI: 0.95, 1.15) and when missing data was treated as cocaine-positive (p = .003; OR = 1.15, 95% CI: 1.06, 1.24 versus OR = 0.96, 95% CI: 0.88, 1.05).
","['ADHD patients', 'patients with CUD']","['mixed amphetamine salts-extended release (MAS-ER', 'daily 60\u2009mg MAS-ER, 80\u2009mg\u2009MAS-ER, or placebo, in conjunction with cognitive behavioral therapy', 'amphetamine', 'placebo']",['baseline Barratt Impulsiveness Scale (BIS-11) score'],"[{'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0053723', 'cui_str': 'bis(cyclohexylammonium)'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.145481,"The odds of a cocaine-abstinent week over time were significantly greater in the high BIS group compared to the low BIS group, both when missing data was treated as missing (p = .0155; OR = 1.23, 95% CI: 1.13, 1.35 versus OR = 1.04, 95% CI: 0.95, 1.15) and when missing data was treated as cocaine-positive (p = .003; OR = 1.15, 95% CI: 1.06, 1.24 versus OR = 0.96, 95% CI: 0.88, 1.05).
","[{'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Blevins', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, NY, United States; Division on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, United States. Electronic address: derek.blevins@nyspi.columbia.edu.'}, {'ForeName': 'C Jean', 'Initials': 'CJ', 'LastName': 'Choi', 'Affiliation': 'Mental Health Data Science, New York State Psychiatric Institute, New York, NY, United States.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': 'Department of Biostatistics, Columbia University Mailman School of Public Health, New York, NY, United States.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Martinez', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, NY, United States; Division on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, United States.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Mariani', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, NY, United States; Division on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Grabowski', 'Affiliation': 'Department of Psychiatry, University of Minnesota Twin Cities, Minneapolis, MN, United States.'}, {'ForeName': 'Frances R', 'Initials': 'FR', 'LastName': 'Levin', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, NY, United States; Division on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108082']
3261,32485622,Effects of cognitive-behavioural therapy for stress management on stress and hair cortisol levels in pregnant women: A randomised controlled trial.,"OBJECTIVE


To demonstrate the effectiveness of a cognitive behavioural therapy for stress management in pregnant women in the reduction of psychological stress and hair cortisol levels.
METHODS


The trial was controlled and randomised, with a total of 78 pregnant women: control group (n-39) and Cognitive Behavioural Therapy group (n-39). To test the therapy's efficacy, an evaluation of the primary outcome (hair cortisol levels) and secondary outcomes (psychological stress, psychopathological symptomatology and resilience) was conducted before and after the treatment. The therapy was conducted during 8 sessions (one per week) in a group setting. The study was registered as a Randomised Controlled Trial with the code NCT03404141.
RESULTS


The results showed a group time interaction between hair cortisol levels, psychological stress (perceived and pregnancy-specific), and in the exacerbation and severity of psychopathological symptoms. These variables presented reductions after treatment only in the Cognitive Behavioural Therapy group.
CONCLUSIONS


Using a novel way of assessing chronic stress (psychological and objective measures as hair cortisol levels), this is the first study that has shown a decrease in both the levels of cortisol in hair and in psychological stress. This decline could have implications for maternal and fetal health.",2020,"These variables presented reductions after treatment only in the Cognitive Behavioural Therapy group.
","['78 pregnant women', 'pregnant women in the reduction of psychological stress and hair cortisol levels', 'pregnant women']","['cognitive behavioural therapy', 'cognitive-behavioural therapy', 'control group (n-39) and Cognitive Behavioural Therapy group (n-39']","['hair cortisol levels, psychological stress (perceived and pregnancy-specific), and in the exacerbation and severity of psychopathological symptoms', 'primary outcome (hair cortisol levels) and secondary outcomes (psychological stress, psychopathological symptomatology and resilience', 'stress and hair cortisol levels']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",78.0,0.0699261,"These variables presented reductions after treatment only in the Cognitive Behavioural Therapy group.
","[{'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Romero-Gonzalez', 'Affiliation': 'Brain, Mind and Behavior Research Center (CIMCYC), Faculty of Psychology, University of Granada, Granada, Spain; Department of Personality, Assessment and Psychological Treatment, University of Granada, Granada, Spain.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Puertas-Gonzalez', 'Affiliation': 'Brain, Mind and Behavior Research Center (CIMCYC), Faculty of Psychology, University of Granada, Granada, Spain; Department of Personality, Assessment and Psychological Treatment, University of Granada, Granada, Spain.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Strivens-Vilchez', 'Affiliation': 'Midwifery Department, Gongora Primary Health Center, Granada, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Gonzalez-Perez', 'Affiliation': 'Department of Pharmacology, CIBERehd, School of Pharmacy, Instituto de Investigación Biosanitariaibs.GRANADA, University of Granada, Granada, Spain. Electronic address: raquel.gonzalez@ciberehd.org.'}, {'ForeName': 'M Isabel', 'Initials': 'MI', 'LastName': 'Peralta-Ramirez', 'Affiliation': 'Department of Personality, Assessment and Psychological Treatment, University of Granada, Granada, Spain.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110162']
3262,32485633,Effect of hippotherapy on walking performance and gait parameters in people with multiple sclerosis.,"BACKGROUND


Walking dysfunction is one of the most common symptoms of multiple sclerosis (MS).
OBJECTIVE


To evaluate the effects of an 8-week hippotherapy intervention on walking performance and spatiotemporal gait parameters in people with relapsing-remitting MS; and to examine whether the effects of hippotherapy on walking performance are mediated by changes in spatiotemporal gait parameters.
METHODS


Participants were assigned into a hippotherapy intervention group (n = 17) or a control group (n = 16). The intervention included 16 sessions of 30-minutes of hippotherapy conducted twice a week. Participants underwent the 25-foot walk test (T25FW) and 6-minute walk test (6MWT), as primary outcomes, and spatiotemporal gait evaluation using GaitRite system, as secondary outcomes, before and after intervention. The data were examined using mixed model ANOVA with Bonferroni post hoc. Mediation analysis was conducted as per Baron and Kenny's criteria.
RESULTS


Compared with control, the intervention group significantly increased 6MWT distance (+9.70%, p<0.001) and decreased T25FW time (-15.86%, p<0.001).Regarding spatiotemporal gait parameters, the intervention group exhibited significantly greater improvements in most variables (Δ% from 3.66 and 41.43%; all p<0.005) than control. Only balance time (p = 0.043), stance time (p = 0.031), and absolute (p = 0.004) and relative (p = 0.017) double support time were identified as significant mediators of the effects of hippotherapy on walking performance evaluated by T25FW. There was no significant mediator for 6MWT (all p>0.05).
CONCLUSION


Hippotherapy improved walking performance and spatiotemporal gait parameters in people with relapsing-remitting MS, and changes in walking performance, evaluated by T25FW, were partially driven by reduction in stance time and double support time and increase in balance time. Hippotherapy may be a useful complimentary treatment approach for improving walking in people with MS.",2020,"Compared with control, the intervention group significantly increased 6MWT distance (+9.70%, p<0.001) and decreased T25FW time (-15.86%, p<0.001).Regarding spatiotemporal gait parameters, the intervention group exhibited significantly greater improvements in most variables (Δ% from 3.66 and 41.43%; all p<0.005) than control.","['people with relapsing-remitting MS', 'people with multiple sclerosis', 'Participants', 'people with MS']","['hippotherapy intervention', 'Hippotherapy', 'hippotherapy', '25-foot walk test (T25FW) and 6-minute walk test (6MWT']","['T25FW time', 'walking performance and spatiotemporal gait parameters', '6MWT distance', 'walking performance and gait parameters', 'stance time', 'balance time']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0454416', 'cui_str': 'Hippotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",,0.0352318,"Compared with control, the intervention group significantly increased 6MWT distance (+9.70%, p<0.001) and decreased T25FW time (-15.86%, p<0.001).Regarding spatiotemporal gait parameters, the intervention group exhibited significantly greater improvements in most variables (Δ% from 3.66 and 41.43%; all p<0.005) than control.","[{'ForeName': 'Andréa Gomes', 'Initials': 'AG', 'LastName': 'Moraes', 'Affiliation': 'Laboratory of Human Motion Analysis, Faculty of Physical Education, University of Brasilia, Brasilia, DF, Brazil. Electronic address: deyafisio9@hotmail.com.'}, {'ForeName': 'Silvia Gonçalves Ricci', 'Initials': 'SGR', 'LastName': 'Neri', 'Affiliation': 'Laboratory of Human Motion Analysis, Faculty of Physical Education, University of Brasilia, Brasilia, DF, Brazil.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Motl', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham,Birmingham, AL, United States.'}, {'ForeName': 'Carlos Bernardo', 'Initials': 'CB', 'LastName': 'Tauil', 'Affiliation': 'Faculty of Medicine, University of Brasília, DF, Brazil.'}, {'ForeName': 'Felipe von', 'Initials': 'FV', 'LastName': 'Glehn', 'Affiliation': 'Department of Medical Clinic, Faculty of Medicine, University of Brasilia, Brasilia, DF and Department of Immunology, University of Unicamp, SP, Brazil.'}, {'ForeName': 'Éber Castro', 'Initials': 'ÉC', 'LastName': 'Corrêa', 'Affiliation': 'Clinen, Neurology and Endocrinology Clinic, Brasília, DF, Bazil.'}, {'ForeName': 'Ana Cristina', 'Initials': 'AC', 'LastName': 'de David', 'Affiliation': 'Laboratory of Human Motion Analysis, Faculty of Physical Education, University of Brasilia, Brasilia, DF, Brazil.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102203']
3263,32485640,Improving B-mode ultrasound diagnostic performance for focal liver lesions using deep learning: A multicentre study.,"BACKGROUND


The diagnosis performance of B-mode ultrasound (US) for focal liver lesions (FLLs) is relatively limited. We aimed to develop a deep convolutional neural network of US (DCNN-US) for aiding radiologists in classification of malignant from benign FLLs.
MATERIALS AND METHODS


This study was conducted in 13 hospitals and finally 2143 patients with 24,343 US images were enrolled. Patients who had non-cystic FLLs with pathological results were enrolled. The FLLs from 11 hospitals were randomly divided into training and internal validations (IV) cohorts with a 4:1 ratio for developing and evaluating DCNN-US. Diagnostic performance of the model was verified using external validation (EV) cohort from another two hospitals. The diagnosis value of DCNN-US was compared with that of contrast enhanced computed tomography (CT)/magnetic resonance image (MRI) and 236 radiologists, respectively.
FINDINGS


The AUC of Model LBC  for FLLs was 0.924 (95% CI: 0.889-0.959) in the EV cohort. The diagnostic sensitivity and specificity of Model LBC  were superior to 15-year skilled radiologists (86.5% vs 76.1%, p = 0.0084 and 85.5% vs 76.9%, p = 0.0051, respectively). Accuracy of Model LBC  was comparable to that of contrast enhanced CT (both 84.7%) but inferior to contrast enhanced MRI (87.9%) for lesions detected by US.
INTERPRETATION


DCNN-US with high sensitivity and specificity in diagnosing FLLs shows its potential to assist less-experienced radiologists in improving their performance and lowering their dependence on sectional imaging in liver cancer diagnosis.",2020,"INTERPRETATION


DCNN-US with high sensitivity and specificity in diagnosing FLLs shows its potential to assist less-experienced radiologists in improving their performance and lowering their dependence on sectional imaging in liver cancer diagnosis.","['focal liver lesions using deep learning', '11 hospitals', '13 hospitals and finally 2143 patients with 24,343 US images were enrolled', 'Patients who had non-cystic FLLs with pathological results were enrolled']",['deep convolutional neural network of US (DCNN-US'],"['AUC of Model LBC  for FLLs', 'Diagnostic performance', 'diagnostic sensitivity and specificity of Model LBC  were superior to 15-year skilled radiologists']","[{'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0577053', 'cui_str': 'Lesion of liver'}, {'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0205207', 'cui_str': 'Cystic'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0242406', 'cui_str': 'Neural Networks (Anatomic)'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C1318045', 'cui_str': 'AKAP13 protein, human'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0577053', 'cui_str': 'Lesion of liver'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0260194', 'cui_str': 'Radiologist'}]",2143.0,0.0256485,"INTERPRETATION


DCNN-US with high sensitivity and specificity in diagnosing FLLs shows its potential to assist less-experienced radiologists in improving their performance and lowering their dependence on sectional imaging in liver cancer diagnosis.","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Jingwei', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'Key Laboratory of Molecular Imaging, Institute of Automation, Chinese Academy of Sciences, Beijing, China; University of Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Xiaohan', 'Initials': 'X', 'LastName': 'Hao', 'Affiliation': 'Key Laboratory of Molecular Imaging, Institute of Automation, Chinese Academy of Sciences, Beijing, China; University of Chinese Academy of Sciences, Beijing, China; Centers for Biomedical Engineering, University of Science and Technology of China, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Dexing', 'Initials': 'D', 'LastName': 'Kong', 'Affiliation': 'School of Mathematical Sciences, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Tianan', 'Initials': 'T', 'LastName': 'Jiang', 'Affiliation': 'Department of Ultrasound, the First Affiliated hospital, College of Medicine, Zhejiang University, Hangzhou, Jiangsu, China.'}, {'ForeName': 'Junqing', 'Initials': 'J', 'LastName': 'Xi', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Wenjia', 'Initials': 'W', 'LastName': 'Cai', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Yanchun', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Jing', 'Affiliation': 'Department of Ultrasound, Tianjin Third Central Hospital, Tianjin, China.'}, {'ForeName': 'Yilin', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Ultrasound Diagnosis, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Cheng', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Jinyu', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Ultrasound, Harbin The First Hospital, Harbin, China.'}, {'ForeName': 'Huiping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Department of Medical Ultrasound, Ma'anshan People's Hospital, Ma'anshan, China.""}, {'ForeName': 'Jintang', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Department of Diagnostic Ultrasound, Xiangya Hospital, Changsha, China.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Zhou', 'Affiliation': ""Department of Ultrasound, Central Theater Command General Hospital, Chinese People's Liberation Army, Wuhan, China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Diagnostic Ultrasound, The Second Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Ultrasound, Beijing Ditan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhiyu', 'Initials': 'Z', 'LastName': 'Han', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Department of Ultrasound, Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': 'Department of Ultrasound, Fujian Cancer Hospital&Fujian Medical University Cancer Hospita, Fuzhou, China.'}, {'ForeName': 'Fangyi', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Dou', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Rongqin', 'Initials': 'R', 'LastName': 'Zheng', 'Affiliation': 'Guangdong Key Laboratory of Liver Disease Research, Department of Medical Ultrasound, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China. Electronic address: zhengrq@mail.sysu.edu.cn.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China. Electronic address: jiemi301@163.com.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Key Laboratory of Molecular Imaging, Institute of Automation, Chinese Academy of Sciences, Beijing, China; University of Chinese Academy of Sciences, Beijing, China; Beijing Advanced Innovation Center for Big Data-Based Precision Medicine, School of Medicine, Beihang University, Beijing, China. Electronic address: jie.tian@ia.ac.cn.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Liang', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China. Electronic address: liangping301@hotmail.com.'}]",EBioMedicine,['10.1016/j.ebiom.2020.102777']
3264,31872860,Examining the optimal timing for closed-loop auditory stimulation of slow-wave sleep in young and older adults.,"STUDY OBJECTIVES


Closed-loop auditory stimulation (CLAS) is a method for enhancing slow oscillations (SOs) through the presentation of auditory clicks during sleep. CLAS boosts SOs amplitude and sleep spindle power, but the optimal timing for click delivery remains unclear. Here, we determine the optimal time to present auditory clicks to maximize the enhancement of SO amplitude and spindle likelihood.
METHODS


We examined the main factors predicting SO amplitude and sleep spindles in a dataset of 21 young and 17 older subjects. The participants received CLAS during slow-wave-sleep in two experimental conditions: sham and auditory stimulation. Post-stimulus SOs and spindles were evaluated according to the click phase on the SOs and compared between and within conditions.
RESULTS


We revealed that auditory clicks applied anywhere on the positive portion of the SO increased SO amplitudes and spindle likelihood, although the interval of opportunity was shorter in the older group. For both groups, analyses showed that the optimal timing for click delivery is close to the SO peak phase. Click phase on the SO wave was the main factor determining the impact of auditory stimulation on spindle likelihood for young subjects, whereas for older participants, the temporal lag since the last spindle was a better predictor of spindle likelihood.
CONCLUSIONS


Our data suggest that CLAS can more effectively boost SOs during specific phase windows, and these differ between young and older participants. It is possible that this is due to the fluctuation of sensory inputs modulated by the thalamocortical networks during the SO.",2020,"Click-phase on the SO wave was the main factor determining the impact of auditory stimulation on spindle likelihood for young subjects, whereas for older participants the temporal lag since the last spindle was a better predictor of spindle likelihood.
","['twenty-one young and seventeen older subjects', 'young and older adults', 'young and older participants']","['Closed loop auditory stimulation (CLAS', 'CLAS during slow-wave-sleep in two experimental conditions: sham and auditory stimulation']",[],"[{'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C0001164', 'cui_str': 'Stimulation, Auditory'}, {'cui': 'C0234451', 'cui_str': 'Sleep, Slow-Wave'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]",[],21.0,0.0317339,"Click-phase on the SO wave was the main factor determining the impact of auditory stimulation on spindle likelihood for young subjects, whereas for older participants the temporal lag since the last spindle was a better predictor of spindle likelihood.
","[{'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Navarrete', 'Affiliation': 'Cardiff University Brain Research Imaging Centre (CUBRIC), School of Psychology, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Jules', 'Initials': 'J', 'LastName': 'Schneider', 'Affiliation': 'School of Biological Sciences, University of Manchester, Manchester, UK.'}, {'ForeName': 'Hong-Viet V', 'Initials': 'HV', 'LastName': 'Ngo', 'Affiliation': 'School of Psychology, University of Birmingham, Edgbaston, Birmingham, UK.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Valderrama', 'Affiliation': 'Department of Biomedical Engineering, University of Los Andes, Bogotá, Colombia.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Casson', 'Affiliation': 'School of Electrical and Electronic Engineering, University of Manchester, Manchester, UK.'}, {'ForeName': 'Penelope A', 'Initials': 'PA', 'LastName': 'Lewis', 'Affiliation': 'Cardiff University Brain Research Imaging Centre (CUBRIC), School of Psychology, Cardiff University, Cardiff, UK.'}]",Sleep,['10.1093/sleep/zsz315']
3265,30577899,Does a history of violent offending impact treatment response for comorbid PTSD and substance use disorders? A secondary analysis of a randomized controlled trial.,,2019,,[],[],[],[],[],[],,0.135423,,"[{'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'López-Castro', 'Affiliation': 'The City College of New York, The City University of New York, 160 Convent Avenue, NAC Building 7/120, New York, NY 10031, USA. Electronic address: tlopezcastro@ccny.cuny.edu.'}, {'ForeName': 'Kathryn Z', 'Initials': 'KZ', 'LastName': 'Smith', 'Affiliation': 'New York State Psychiatric Institute, Division on Substance Use Disorders, 1051 Riverside Drive, New York, NY 10032, USA.'}, {'ForeName': 'Ronald A', 'Initials': 'RA', 'LastName': 'Nicholson', 'Affiliation': 'The City College of New York, The City University of New York, 160 Convent Avenue, NAC Building 7/120, New York, NY 10031, USA.'}, {'ForeName': 'Aeriell', 'Initials': 'A', 'LastName': 'Armas', 'Affiliation': 'The City College of New York, The City University of New York, 160 Convent Avenue, NAC Building 7/120, New York, NY 10031, USA.'}, {'ForeName': 'Denise A', 'Initials': 'DA', 'LastName': 'Hien', 'Affiliation': 'Center of Alcohol Studies, Graduate School of Applied and Professional Psychology, Rutgers, The State University of New Jersey, Smithers Hall, 607 Allison Road, Piscataway, NJ 08854, USA. Electronic address: denise.hien@smithers.rutgers.edu.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2018.11.009']
3266,31411989,"Re: Christopher C. Parker, Nicholas D. James, Christopher D. Brawley, et al. Radiotherapy to the Primary Tumour for Newly Diagnosed, Metastatic Prostate Cancer (STAMPEDE): A Randomised Controlled Phase 3 Trial. Lancet 2018;392:2353-66: Metastatic Hormone-naïve Prostate Cancer: A Multimodal Approach for a Heterogeneous Disease.",,2020,,"['Metastatic Hormone-naïve Prostate Cancer', 'Newly Diagnosed, Metastatic Prostate Cancer (STAMPEDE']",['Radiotherapy'],[],"[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C1282496', 'cui_str': 'Metastasis from malignant tumor of prostate'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]",[],,0.0310658,,"[{'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Di Nunno', 'Affiliation': 'Division of Oncology, S. Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Santoni', 'Affiliation': 'Oncology Unit, Macerata Hospital, Macerata, Italy.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Gatto', 'Affiliation': 'Division of Oncology, S. Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Mollica', 'Affiliation': 'Division of Oncology, S. Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Massari', 'Affiliation': 'Division of Oncology, S. Orsola-Malpighi Hospital, Bologna, Italy. Electronic address: fmassari79@gmail.com.'}]",European urology oncology,['10.1016/j.euo.2019.02.005']
3267,31764095,HIV-1 genetic diversity to estimate time of infection and infer adherence to preexposure prophylaxis.,"OBJECTIVE


To estimate time of HIV infection in participants from the Bangkok Tenofovir Study (BTS) with daily oral tenofovir disoproxil fumarate (TDF) for preexposure prophylaxis (PrEP) and relate infection with adherence patterns.
DESIGN


We used the diversity structure of the virus population at the first HIV RNA-positive sample to estimate the date of infection, and mapped these estimates to medication diaries obtained under daily directly observed therapy (DOT).
METHODS


HIV genetic diversity was investigated in all 17 PrEP breakthrough infections and in 16 placebo recipients. We generated 10-25 HIV env sequences from each participant by single genome amplification, and calculated time since infection (and 95% confidence interval) using Poisson models of early virus evolution. Study medication diaries obtained under daily DOT were then used to compute the number of missed TDF doses at the approximate date of infection.
RESULTS


Fifteen of the 17 PrEP breakthrough infections were successfully amplified. Of these, 13 were initiated by a single genetic variant and generated reliable estimates of time since infection (median = 47 [IQR = 35] days). Eleven of these 13 were under daily DOT at the estimated time of infection. Analysis of medication diaries in these 11 participants showed 100% adherence in five, 90-95% adherence in two, 55% adherence in one, and nonadherence in three.
CONCLUSION


We estimated time of infection in participants from BTS and found several infections when high levels of adherence to TDF were reported. Our results suggest that the biological efficacy of daily TDF against parenteral HIV exposure is not 100%.",2019,"Analysis of medication diaries in these 11 participants showed 100% adherence in five, 90-95% adherence in two, 55% adherence in one, and nonadherence in three.
","['participants from the Bangkok Tenofovir Study (BTS) with', 'HIV genetic diversity was investigated in all 17 PrEP breakthrough infections and in 16 placebo recipients']","['daily oral tenofovir disoproxil fumarate (TDF', 'TDF']",[],"[{'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0042333', 'cui_str': 'Genetic Diversity'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C3666010', 'cui_str': 'Breakthrough infection'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}]",[],25.0,0.0747858,"Analysis of medication diaries in these 11 participants showed 100% adherence in five, 90-95% adherence in two, 55% adherence in one, and nonadherence in three.
","[{'ForeName': 'Olivia D', 'Initials': 'OD', 'LastName': 'Council', 'Affiliation': 'Laboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, US Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Ruone', 'Affiliation': 'Laboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, US Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Mock', 'Affiliation': 'Thailand Ministry of Public Health - U.S. Centers for Disease Control and Prevention Collaboration, Nonthaburi, Thailand.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Khalil', 'Affiliation': 'Quantitative Sciences and Data Management Branch, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'Laboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, US Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Marcel E', 'Initials': 'ME', 'LastName': 'Curlin', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, Oregon Health and Sciences University, Portland, Oregon, USA.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'McNicholl', 'Affiliation': 'Laboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, US Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Walid', 'Initials': 'W', 'LastName': 'Heneine', 'Affiliation': 'Laboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, US Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Wanna', 'Initials': 'W', 'LastName': 'Leelawiwat', 'Affiliation': 'Thailand Ministry of Public Health - U.S. Centers for Disease Control and Prevention Collaboration, Nonthaburi, Thailand.'}, {'ForeName': 'Kachit', 'Initials': 'K', 'LastName': 'Choopanya', 'Affiliation': 'Bangkok Tenofovir Study Group, Bangkok, Thailand.'}, {'ForeName': 'Suphak', 'Initials': 'S', 'LastName': 'Vanichseni', 'Affiliation': 'Bangkok Tenofovir Study Group, Bangkok, Thailand.'}, {'ForeName': 'Thitima', 'Initials': 'T', 'LastName': 'Cherdtrakulkiat', 'Affiliation': 'Thailand Ministry of Public Health - U.S. Centers for Disease Control and Prevention Collaboration, Nonthaburi, Thailand.'}, {'ForeName': 'Rapeepan', 'Initials': 'R', 'LastName': 'Anekvorapong', 'Affiliation': 'Bangkok Tenofovir Study Group, Bangkok, Thailand.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Thailand Ministry of Public Health - U.S. Centers for Disease Control and Prevention Collaboration, Nonthaburi, Thailand.'}, {'ForeName': 'José Gerardo', 'Initials': 'JG', 'LastName': 'García-Lerma', 'Affiliation': 'Laboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, US Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002390']
3268,31410497,ORI monitoring allows a reduction of time with hyperoxia in critically ill patients: the randomized control ORI 2  study.,,2019,,['critically ill patients'],['ORI monitoring'],[],"[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],[],,0.0275738,,"[{'ForeName': 'Sigismond', 'Initials': 'S', 'LastName': 'Lasocki', 'Affiliation': ""Département Anesthésie-Réanimation, UBL Université d'Angers, CHU Angers, 4 rue Larrey, 49933, Angers Cedex 9, France. sigismond@lasocki.com.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Brochant', 'Affiliation': ""Département Anesthésie-Réanimation, UBL Université d'Angers, CHU Angers, 4 rue Larrey, 49933, Angers Cedex 9, France.""}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Leger', 'Affiliation': ""Département Anesthésie-Réanimation, UBL Université d'Angers, CHU Angers, 4 rue Larrey, 49933, Angers Cedex 9, France.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gaillard', 'Affiliation': ""Département Anesthésie-Réanimation, UBL Université d'Angers, CHU Angers, 4 rue Larrey, 49933, Angers Cedex 9, France.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Lemarié', 'Affiliation': ""Département Anesthésie-Réanimation, UBL Université d'Angers, CHU Angers, 4 rue Larrey, 49933, Angers Cedex 9, France.""}, {'ForeName': 'Soizic', 'Initials': 'S', 'LastName': 'Gergaud', 'Affiliation': ""Département Anesthésie-Réanimation, UBL Université d'Angers, CHU Angers, 4 rue Larrey, 49933, Angers Cedex 9, France.""}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Dupré', 'Affiliation': ""Département Anesthésie-Réanimation, UBL Université d'Angers, CHU Angers, 4 rue Larrey, 49933, Angers Cedex 9, France.""}]",Intensive care medicine,['10.1007/s00134-019-05732-9']
3269,31502945,User Experience Affects Dropout from Internet-Delivered Dialectical Behavior Therapy.,"Background:   The emergence of computerized treatment may help reduce the gap between mental health treatment needs and accessibility, but unfortunately, dropout from these interventions is often high.   Introduction:   To increase the effectiveness of computerized interventions and reduce dropout, particularly among high-risk and clinically complex populations, better understanding of how usable and acceptable (i.e., user experience) these interventions are, informed by human computer interaction research, is needed. This study examines user experience of internet-delivered dialectical behavior therapy (iDBT). The major aim is to explore whether treatment dropout was affected by the complexity of population and/or user experience.   Methods:   Secondary analyses were conducted using data from a randomized controlled trial that evaluated iDBT in a sample of 59 suicidal and heavy episodic drinkers. Multivariate logistic regression and chi-square tests were performed to examine the roles of clinical characteristics and user experience in differentiating dropouts and nondropouts.   Results:   The only significant pretreatment predictor of dropout was the presence of a barrier, with technological and unknown barriers being most strongly associated with dropping. No clinical characteristics emerged as significant predictors of dropout.   Discussion:   The current results highlight technological problems as a possible barrier to adherence to computerized interventions. Future research would profit from increased integration of human-computer interaction to identify and solve user experience problems.",2020,"The only significant pretreatment predictor of dropout was the presence of a barrier, with technological and unknown barriers being most strongly associated with dropping.",['59 suicidal and heavy episodic drinkers'],"['iDBT', 'internet-delivered dialectical behavior therapy (iDBT']",[],"[{'cui': 'C0438696', 'cui_str': 'Suicidal (finding)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0556335', 'cui_str': 'Binge drinker (finding)'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C1321145', 'cui_str': 'Dialectical Behavior Therapy'}]",[],59.0,0.0343292,"The only significant pretreatment predictor of dropout was the presence of a barrier, with technological and unknown barriers being most strongly associated with dropping.","[{'ForeName': 'Chelsey R', 'Initials': 'CR', 'LastName': 'Wilks', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Yin', 'Affiliation': 'Department of Psychology, Eastern Michigan University, Ypsilanti, Michigan, USA.'}, {'ForeName': 'Kelly L', 'Initials': 'KL', 'LastName': 'Zuromski', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, Massachusetts, USA.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2019.0124']
3270,30870539,Bariatric surgery + medical therapy: Effective Tx for T2DM?,"Short-term studies have indicated ""Yes,"" but does a longterm randomized controlled trial give it a thumbs up?",2019,"Short-term studies have indicated ""Yes,"" but does a longterm randomized controlled trial give it a thumbs up?",[],['Bariatric surgery + medical therapy'],[],[],"[{'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}]",[],,0.050623,"Short-term studies have indicated ""Yes,"" but does a longterm randomized controlled trial give it a thumbs up?","[{'ForeName': 'Kortnee Y', 'Initials': 'KY', 'LastName': 'Roberson', 'Affiliation': 'University of Chicago, Department of Family Medicine, Chicago, IL, USA.'}, {'ForeName': 'Emily White', 'Initials': 'EW', 'LastName': 'Van Gompel', 'Affiliation': 'University of Chicago, Department of Family Medicine, Chicago, IL, USA.'}, {'ForeName': 'Jennie B', 'Initials': 'JB', 'LastName': 'Jarrett', 'Affiliation': 'University of Illinois at Chicago, Chicago, IL, USA.'}]",The Journal of family practice,[]
3271,31436146,A crossover trial comparing contamination of healthcare personnel during removal of a standard gown versus a modified gown with increased skin coverage at the hands and wrists.,"In a crossover trial, a gown designed to increase skin coverage at the hands and wrists significantly reduced contamination of personnel during personal protective equipment (PPE) removal, and education on donning and doffing technique further reduced contamination. Simple modifications of PPE and education can reduce contamination during PPE removal.",2019,"In a crossover trial, a gown designed to increase skin coverage at the hands and wrists significantly reduced contamination of personnel during personal protective equipment (PPE) removal, and education on donning and doffing technique further reduced contamination.",[],['healthcare personnel'],['skin coverage'],[],"[{'cui': 'C0086388', 'cui_str': 'Health Care'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}]",,0.0170069,"In a crossover trial, a gown designed to increase skin coverage at the hands and wrists significantly reduced contamination of personnel during personal protective equipment (PPE) removal, and education on donning and doffing technique further reduced contamination.","[{'ForeName': 'Zeina', 'Initials': 'Z', 'LastName': 'Hajar', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases and HIV Medicine, University Hospitals Cleveland Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Thriveen S C', 'Initials': 'TSC', 'LastName': 'Mana', 'Affiliation': 'Case Western Reserve University School of Medicine, Cleveland, Ohio.'}, {'ForeName': 'Myreen E', 'Initials': 'ME', 'LastName': 'Tomas', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, Louis Stokes Cleveland VA Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Heba', 'Initials': 'H', 'LastName': 'Alhmidi', 'Affiliation': ""Research Service, Louis Stokes Cleveland Veterans' Affairs Medical Center, Cleveland, Ohio.""}, {'ForeName': 'Brigid M', 'Initials': 'BM', 'LastName': 'Wilson', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, Louis Stokes Cleveland VA Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Curtis J', 'Initials': 'CJ', 'LastName': 'Donskey', 'Affiliation': 'Case Western Reserve University School of Medicine, Cleveland, Ohio.'}]",Infection control and hospital epidemiology,['10.1017/ice.2019.211']
3272,31584141,Mentor's Self-Efficacy Trajectories During a Mentoring Program for At-Risk Adolescents.,"The concept of self-efficacy is dynamic and may change over time. Mentors of youth exposed to risk factors are likely to experience shifts in the degree to which they feel confident in their ability to form a positive mentoring bond with their mentee, potentially affecting the quality of the relationship. Based on previous literature, mentors' personality traits, their perceptions of positive mentee behaviors, and youth risk may influence changes in mentor self-efficacy over time. Our study includes 238 adolescents aged 11-18 years and their mentors who were recruited for a randomized controlled trial of a mentoring-based intervention for at-risk adolescents, known as Campus Connections. We used latent class growth analysis to identify mentor subgroups with different self-efficacy trajectories. Three subgroups emerged: mentors relatively high in self-efficacy throughout the mentoring relationship, the stable group; those high in self-efficacy at the beginning of the relationship and increasingly so, the increasing group; and those moderately high in self-efficacy and decreasingly so, the decreasing group. Greater mentor conscientiousness, extraversion, and agreeableness were associated with greater likelihood of belonging to the increasing group relative to the decreasing group. Greater mentor emotionality was associated with greater likelihood of belonging to the decreasing relative to the increasing group. Mentors and mentees were also more likely to report having a positive mentoring alliance in the increasing relative to the decreasing group. We found that mentor personality traits play an important role in how mentors perceive their ability to serve as a mentor, which may have implications for mentor recruitment and training in programs designed for at-risk youth.",2019,Greater mentor emotionality was associated with greater likelihood of belonging to the decreasing relative to the increasing group.,"['At-Risk Adolescents', '238 adolescents aged 11-18\xa0years and their mentors']",['mentoring-based intervention'],"[""Mentor's Self-Efficacy Trajectories""]","[{'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}]","[{'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",238.0,0.0172784,Greater mentor emotionality was associated with greater likelihood of belonging to the decreasing relative to the increasing group.,"[{'ForeName': 'Ashley A', 'Initials': 'AA', 'LastName': 'Boat', 'Affiliation': 'The Improve Group, 661 LaSalle Ave, St. Paul, MN, 55114, USA. chesm002@umn.edu.'}, {'ForeName': 'Lindsey M', 'Initials': 'LM', 'LastName': 'Weiler', 'Affiliation': 'Department of Family Social Science, University of Minnesota Twin Cities, St. Paul, USA.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Bailey', 'Affiliation': 'Department of Family Social Science, University of Minnesota Twin Cities, St. Paul, USA.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Haddock', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, Fort Collins, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Henry', 'Affiliation': 'Department of Psychology, Colorado State University, Fort Collins, USA.'}]",The journal of primary prevention,['10.1007/s10935-019-00566-z']
3273,31530065,Cost-effectiveness of telerehabilitation versus traditional care after total hip replacement: A trial-based economic evaluation.,"INTRODUCTION


Physical rehabilitation for total hip replacement patients following hospital discharge is beneficial; however, accessing rehabilitation is often challenging. Telerehabilitation helps negate access issues and is efficacious in total knee and hip replacement patients. This study aims to compare the cost-effectiveness of a telerehabilitation programme delivered remotely into patients' homes versus traditional care for total hip replacement patients following hospital discharge.
METHODS


A cost-effectiveness (cost-utility) analysis was conducted from the perspective of a health service alongside a two-arm randomised controlled trial comparing telerehabilitation ( n =35) with in-person care ( n =35) following hospital discharge after total hip replacement. The primary analysis used an Incremental Cost-Effectiveness Ratio to compare the cost per Quality Adjusted Life Year (QALY) accrued in the telerehabilitation group versus in-person control using costs and effects data from the randomised trial. A secondary analysis was conducted whereby the time accrued by patients attending rehabilitation sessions (including travel time) was considered the ""cost"" (i.e. a time burden), rather than cost from the health service perspective.
RESULTS


Estimated mean differences in healthcare costs and QALYs gained were detected but were not significant. The estimated mean (95%CI) difference in cost of telerehabilitation versus in-person was -$28.90 (-$96.37 to $40.45), favouring the telerehabilitation group. The estimated mean (95%CI) difference in QALYs gained from telerehabilitation versus in-person was -0.0025 (-0.0227 to 0.0217). The estimated mean (95%CI) difference in time burden favoured less time burden for the telerehabilitation group (-4.21 (-4.69 to -3.74) hours).
DISCUSSION


Telerehabilitation in the total hip replacement population incurred similar costs and yielded similar effects to traditional in-person care. Telerehabilitation significantly reduced the time burden for patients and carers. These findings are valuable for healthcare providers seeking to implement accessible patient-centred rehabilitation services.",2019,,[],['telerehabilitation versus traditional care after total hip replacement'],[],[],"[{'cui': 'C4042802', 'cui_str': 'Tele-rehabilitation'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0040508', 'cui_str': 'Hip Replacement, Total'}]",[],,0.0178466,,"[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Nelson', 'Affiliation': 'QEII Jubilee Hospital, Metro South Hospital and Health Service, Brisbane, Australia.'}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Russell', 'Affiliation': 'Faculty of Health and Behavioural Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Crossley', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, College of Science, Health and Engineering, Melbourne, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bourke', 'Affiliation': 'Faculty of Health and Behavioural Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'McPhail', 'Affiliation': 'Queensland University of Technology, Institute of Health and Biomedical Innovation and School of Public Health & Social Work, Brisbane, Australia.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19869796']
3274,31605528,Transient Immune Activation in BCG-Vaccinated Infant Rhesus Macaques Is Not Sufficient to Influence Oral Simian Immunodeficiency Virus Infection.,"BCG vaccination has been demonstrated to increase levels of activated CD4+ T cells, thus potentially influencing mother-to-child transmission of human immunodeficiency virus (HIV). To assess the risk of BCG vaccination in HIV infection, we randomly assigned newborn rhesus macaques to receive BCG vaccine or remain unvaccinated and then undergo oral simian immunodeficiency virus (SIV) challenges 3 weeks later. We observed elevated levels of activated peripheral CD4+ T cells (ie, HLA-DR+CD38+CCR5+ CD4+ T cells) by week 3 after vaccination. BCG was also associated with an altered immune gene expression profile, as well as with monocyte activation in both peripheral blood and the draining axillary lymph node, indicating significant BCG vaccine-induced immune activation. Despite these effects, BCG vaccination did not increase the rate of SIV oral transmission or disease progression. Our findings therefore identify patterns of T-cell and monocyte activation that occur after BCG vaccination but do not support the hypothesis that BCG vaccination is a risk factor for postnatal HIV transmission or increased pathogenesis in infants.",2020,"BCG was also associated with an altered immune gene expression profile, as well as with monocyte activation in both peripheral blood and the draining axillary lymph node, indicating significant BCG vaccine-induced immune activation.",[],"['BCG', 'BCG vaccination', 'BCG vaccine']","['activated peripheral CD4+ T cells (ie, HLA-DR+CD38+CCR5+ CD4+ T cells', 'rate of SIV oral transmission or disease progression']",[],"[{'cui': 'C0085957', 'cui_str': 'BCG'}, {'cui': 'C0199804', 'cui_str': 'BCG immunization'}, {'cui': 'C0004886', 'cui_str': 'BCG Vaccine'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}]",,0.0343655,"BCG was also associated with an altered immune gene expression profile, as well as with monocyte activation in both peripheral blood and the draining axillary lymph node, indicating significant BCG vaccine-induced immune activation.","[{'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Wood', 'Affiliation': ""Center for Global Infectious Disease Research, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Lianna F', 'Initials': 'LF', 'LastName': 'Wood', 'Affiliation': ""Center for Global Infectious Disease Research, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Templeton', 'Affiliation': ""Center for Global Infectious Disease Research, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Fisher', 'Affiliation': ""Center for Global Infectious Disease Research, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Lippy', 'Affiliation': ""Center for Global Infectious Disease Research, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Chloe I', 'Initials': 'CI', 'LastName': 'Jones', 'Affiliation': ""Center for Global Infectious Disease Research, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Cecilia S', 'Initials': 'CS', 'LastName': 'Lindestam Arlehamn', 'Affiliation': 'Division of Vaccine Discovery, La Jolla Institute for Immunology, San Diego.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Sette', 'Affiliation': 'Division of Vaccine Discovery, La Jolla Institute for Immunology, San Diego.'}, {'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'Fuller', 'Affiliation': 'Department of Microbiology, Seattle, Washington; and University of Washington.'}, {'ForeName': 'Patience', 'Initials': 'P', 'LastName': 'Murapa', 'Affiliation': 'Department of Microbiology, Seattle, Washington; and University of Washington.'}, {'ForeName': 'Heather B', 'Initials': 'HB', 'LastName': 'Jaspan', 'Affiliation': ""Center for Global Infectious Disease Research, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Deborah H', 'Initials': 'DH', 'LastName': 'Fuller', 'Affiliation': 'Department of Microbiology, Seattle, Washington; and University of Washington.'}, {'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'Sodora', 'Affiliation': ""Center for Global Infectious Disease Research, Seattle Children's Research Institute, Seattle, Washington.""}]",The Journal of infectious diseases,['10.1093/infdis/jiz382']
3275,31694484,"Speech perception, real-ear measurements and self-perceived hearing impairment after remote and face-to-face programming of hearing aids: A randomized single-blind agreement study.","INTRODUCTION


Current literature does not provide strong evidence that remote programming of hearing aids is effective, despite its increasing use by audiologists. We tested speech perception outcomes, real-ear insertion gain, and changes in self-perceived hearing impairment after face-to-face and remote programming of hearing aids in a randomized multicentre, single-blind crossover study.
METHODS


Adult experienced hearing aid users were enrolled during routine follow-up visits to audiology clinics. Hearing aids were programmed both face to face and remotely, then participants randomly received either the face-to-face or remote settings in a blinded manner and were evaluated 5 weeks later. Participants then received the other settings and were evaluated 5 weeks later.
RESULTS


Data from 52 out of 60 participants were analysed. We found excellent concordance in performance of hearing aids programmed face to face and remotely for speech understanding in quiet (phonetically balanced kindergarten test - intraclass correlation coefficient of 0.92 (95% confidence interval: 0.87-0.95)), and good concordance in performance for speech understanding in noise (phonetically balanced kindergarten +5 dB signal-to-noise ratio - intraclass correlation coefficient of 0.71 (95% confidence interval: 0.55-0.82)). Face-to-face and remote programming took 10 minutes (±2.9) and 10 minutes (±2.8), respectively. Real-ear insertion gains were highly correlated for input sound at 50, 65 and 80 dB sound pressure levels. The programming type did not affect the abbreviated profile of hearing aid questionnaire scores.
CONCLUSIONS


In experienced hearing aid users, face-to-face and remote programming of hearing aids give similar results in terms of speech perception, with no increase in the time spent on patients' care and no difference in self-reported hearing benefit.
CLINICALTRIALS.GOV IDENTIFIER


NCT02589561.",2019,,['hearing aids'],[],"['Speech perception, real-ear measurements and self-perceived hearing impairment']",[],[],"[{'cui': 'C0037826', 'cui_str': 'Speech Perception'}, {'cui': 'C0013443', 'cui_str': 'Vestibulocochlear Apparatus'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]",,0.0178994,,"[{'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Venail', 'Affiliation': 'ENT and Audiology Department, University Hospital Gui de Chauliac, France.'}, {'ForeName': 'Marie C', 'Initials': 'MC', 'LastName': 'Picot', 'Affiliation': 'Biostatistics & Clinical Research Unit, University Montpellier, France.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Marin', 'Affiliation': 'Biostatistics & Clinical Research Unit, University Montpellier, France.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Falinower', 'Affiliation': 'AudioProConnect Company, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Samson', 'Affiliation': 'AudioProConnect Company, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Cizeron', 'Affiliation': 'AudioProConnect Company, France.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Balcon', 'Affiliation': 'ENT and Audiology Department, University Hospital Gui de Chauliac, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Blanc', 'Affiliation': 'Audition Conseil, Nîmes, France.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Bricaud', 'Affiliation': 'Audition Conseil, Perpignan, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Lorenzi', 'Affiliation': 'ENT and Audiology Department, University Hospital Gui de Chauliac, France.'}, {'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Ceccato', 'Affiliation': 'Auditory Disorders, Institute for Neurosciences of Montpellier, INSERM, France.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Puel', 'Affiliation': 'Auditory Disorders, Institute for Neurosciences of Montpellier, INSERM, France.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19883543']
3276,31425397,Implementing Data to Care-What Are the Costs for the Health Department?,"BACKGROUND


The Cooperative Re-Engagement Controlled Trial (CoRECT) is a randomized controlled trial that uses a combined health department-provider data to care (D2C) model to identify out-of-care HIV-infected persons. We present cost data for programmatic aspects of the trial during the start-up period (first 30 days of the study).
METHODS


We used microcosting methods to estimate health department start-up costs. We collected start-up cost data between September 2016 and December 2016; 3 health departments completed a form to capture expenses for the initial 30 days of study implementation; the start date varied by health department. All costs are expressed in 2016 US dollars.
RESULTS


Among the 3 health departments, the total start-up costs ranged from $14,145 to $26,058. Total start-up labor hours ranged from 224 to 640 hours.
CONCLUSIONS


As D2C expands nationally with cooperative agreement, PS 18-1802 health departments may be able to use a similar analysis to consider the labor, time, and resources needed to implement D2C within their jurisdiction.",2019,"Among the 3 health departments, the total start-up costs ranged from $14,145 to $26,058.",[],[],['total start-up costs'],[],[],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.0477273,"Among the 3 health departments, the total start-up costs ranged from $14,145 to $26,058.","[{'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Neblett Fanfair', 'Affiliation': 'Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA.'}, {'ForeName': 'Ram K', 'Initials': 'RK', 'LastName': 'Shrestha', 'Affiliation': 'Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA.'}, {'ForeName': 'Liisa', 'Initials': 'L', 'LastName': 'Randall', 'Affiliation': 'Massachusetts Department of Public Health, Boston, MA.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Lucas', 'Affiliation': 'Philadelphia Department of Public Health, Philadelphia, PA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Nichols', 'Affiliation': 'Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Nasima M', 'Initials': 'NM', 'LastName': 'Camp', 'Affiliation': 'Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Brady', 'Affiliation': 'Philadelphia Department of Public Health, Philadelphia, PA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Jenkins', 'Affiliation': 'Connecticut Department of Public Health, Hartford, CT.'}, {'ForeName': 'Fredrick', 'Initials': 'F', 'LastName': 'Altice', 'Affiliation': 'Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Merceditas', 'Initials': 'M', 'LastName': 'Villanueva', 'Affiliation': 'Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'DeMaria', 'Affiliation': 'Massachusetts Department of Public Health, Boston, MA.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000001968']
3277,31852502,The side effects of service changes: exploring the longitudinal impact of participation in a randomised controlled trial (DOORWAYS) on staff perceptions of barriers to change.,"BACKGROUND


Staff and service users have expressed concerns that service improvements in British mental health wards have been slow or transient. It is possible that certain changes are positive for some (e.g. service users), but negative for others (e.g. staff), which may affect implementation success. In this study, we explore whether a programme of change to improve the therapeutic milieu on mental health wards influenced staff perceptions of barriers to change, 12 months after implementation.
METHOD


A cluster randomised controlled trial called DOORWAYS was conducted on eight British, inner-city acute mental health wards. Randomisation was achieved using a list randomly generated by a computer. A psychologist trained ward staff (mainly nurses) to deliver evidence-based groups and supported their initial implementation. The impact of these changes was measured over 12 months (when 4 wards were randomised), according to nurses' perceptions of barriers to change (VOCALISE), using unstructured multivariate linear regression models. This innovative analysis method allows maximum use of data in randomised controlled trials with reduced sample sizes due to substantial drop out rates. The contextual influences of occupational status (staff) and of workplace setting (ward) were also considered.
RESULTS


Staff who participated in the intervention had significantly worse perceptions of barriers to change at follow up. The perceptions of staff in the control group did not change over time. In both groups (N = 120), direct care staff had more negative perceptions of barriers to change, and perceptions varied according to ward. Across time, direct care staff in the intervention group became more negative than those in the control group.
CONCLUSION


Participation in this program of change, worsened staff perceptions of barriers to change. In addition, occupational status (being from the direct care group) had a negative effect on perceptions of barriers to change, an effect that continued across time and was worse in the intervention group. Those providing direct care should be offered extra support when changes are introduced and through the implementation process. More effort should be placed around reducing the perceived burden of innovation for staff in mental health wards.
TRIAL REGISTRATION


ISRCTN, ISRCTN 06545047. Registered 29/04/2010, https://www.isrctn.com/search?q=06545047.",2019,"In both groups (N = 120), direct care staff had more negative perceptions of barriers to change, and perceptions varied according to ward.","['British mental health wards', 'eight British, inner-city acute mental health wards']",[],[],"[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0557849', 'cui_str': 'Inner city environment (environment)'}]",[],[],,0.135494,"In both groups (N = 120), direct care staff had more negative perceptions of barriers to change, and perceptions varied according to ward.","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Laker', 'Affiliation': 'Faculty of Health, Education, Medicine and Social Care, Anglia Ruskin University, Chelmsford Campus, Bishop Hall Lane, Chelmsford, Essex, CM1 1SQ, UK. caroline.laker@anglia.ac.uk.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Cella', 'Affiliation': ""Department of Psychology, King's College London, Institute of Psychiatry, Psychology & Neuroscience, PO77, Room 2.11, London Henry Wellcome Building, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Agbediro', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Felicity', 'Initials': 'F', 'LastName': 'Callard', 'Affiliation': 'Birkbeck, Department of Psychosocial Studies, University of London, Malet Street, Bloomsbury, London, WC1E 7HX, UK.'}, {'ForeName': 'Til', 'Initials': 'T', 'LastName': 'Wykes', 'Affiliation': ""Department of Psychology, King's College London, Institute of Psychiatry, Psychology & Neuroscience, PO77, Room 2.11, London Henry Wellcome Building, 16 De Crespigny Park, London, SE5 8AF, UK.""}]",BMC psychiatry,['10.1186/s12888-019-2370-6']
3278,30891610,Surgical Performance Determines Functional Outcome Benefit in the Minimally Invasive Surgery Plus Recombinant Tissue Plasminogen Activator for Intracerebral Hemorrhage Evacuation (MISTIE) Procedure.,"BACKGROUND


Minimally invasive surgery procedures, including stereotactic catheter aspiration and clearance of intracerebral hemorrhage (ICH) with recombinant tissue plasminogen activator hold a promise to improve outcome of supratentorial brain hemorrhage, a morbid and disabling type of stroke. A recently completed Phase III randomized trial showed improved mortality but was neutral on the primary outcome (modified Rankin scale score 0 to 3 at 1 yr).
OBJECTIVE


To assess surgical performance and its impact on the extent of ICH evacuation and functional outcomes.
METHODS


Univariate and multivariate models were used to assess the extent of hematoma evacuation efficacy in relation to mRS 0 to 3 outcome and postulated factors related to patient, disease, and protocol adherence in the surgical arm (n = 242) of the MISTIE trial.
RESULTS


Greater ICH reduction has a higher likelihood of achieving mRS of 0 to 3 with a minimum evacuation threshold of ≤15 mL end of treatment ICH volume or ≥70% volume reduction when controlling for disease severity factors. Mortality benefit was achieved at ≤30 mL end of treatment ICH volume, or >53% volume reduction. Initial hematoma volume, history of hypertension, irregular-shaped hematoma, number of alteplase doses given, surgical protocol deviations, and catheter manipulation problems were significant factors in failing to achieve ≤15 mL goal evacuation. Greater surgeon/site experiences were associated with avoiding poor hematoma evacuation.
CONCLUSION


This is the first surgical trial reporting thresholds for reduction of ICH volume correlating with improved mortality and functional outcomes. To realize the benefit of surgery, protocol objectives, surgeon education, technical enhancements, and case selection should be focused on this goal.",2019,Mortality benefit was achieved at ≤30,[],"['Minimally Invasive Surgery', 'recombinant tissue plasminogen activator', 'stereotactic catheter aspiration', 'Plus Recombinant Tissue Plasminogen Activator']","['Mortality benefit', 'mortality']",[],"[{'cui': 'C0282624', 'cui_str': 'Minimal Surgical Procedures'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0918038,Mortality benefit was achieved at ≤30,"[{'ForeName': 'Issam A', 'Initials': 'IA', 'LastName': 'Awad', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Polster', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Julián', 'Initials': 'J', 'LastName': 'Carrión-Penagos', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Thompson', 'Affiliation': 'Division of Brain Injury Outcomes, Department of Neurology, Johns Hopkins University Medical Institutions, Baltimore, Maryland.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Stadnik', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Patricia Lynn', 'Initials': 'PL', 'LastName': 'Money', 'Affiliation': 'Department of Neurosurgery, University of Cincinnati Medical Center, Cincinnati, Ohio.'}, {'ForeName': 'Maged D', 'Initials': 'MD', 'LastName': 'Fam', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Koskimäki', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Romuald', 'Initials': 'R', 'LastName': 'Girard', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Lane', 'Affiliation': 'Division of Brain Injury Outcomes, Department of Neurology, Johns Hopkins University Medical Institutions, Baltimore, Maryland.'}, {'ForeName': 'Nichol', 'Initials': 'N', 'LastName': 'McBee', 'Affiliation': 'Division of Brain Injury Outcomes, Department of Neurology, Johns Hopkins University Medical Institutions, Baltimore, Maryland.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Ziai', 'Affiliation': 'Division of Brain Injury Outcomes, Department of Neurology, Johns Hopkins University Medical Institutions, Baltimore, Maryland.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Hao', 'Affiliation': 'Division of Brain Injury Outcomes, Department of Neurology, Johns Hopkins University Medical Institutions, Baltimore, Maryland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Dodd', 'Affiliation': 'Department of Neurosurgery, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Carlson', 'Affiliation': 'Department of Neurosurgery, University of New Mexico School of Medicine, Albuquerque, New Mexico.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Camarata', 'Affiliation': 'Department of Neurosurgery, University of Kansas School of Medicine, Kansas City, Kansas.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Caron', 'Affiliation': 'Department of Neurosurgery, University of Texas, San Antonio, Texas.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Harrigan', 'Affiliation': 'Division of Neurosurgery, Department of Surgery, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Gregson', 'Affiliation': 'Neurosurgical Trials Group, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'A David', 'Initials': 'AD', 'LastName': 'Mendelow', 'Affiliation': 'Neurosurgical Trials Group, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Zuccarello', 'Affiliation': 'Department of Neurosurgery, University of Cincinnati Medical Center, Cincinnati, Ohio.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hanley', 'Affiliation': 'Division of Brain Injury Outcomes, Department of Neurology, Johns Hopkins University Medical Institutions, Baltimore, Maryland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurosurgery,['10.1093/neuros/nyz077']
3279,31394131,JAAD Game Changers: Improved clinical outcome and biomarkers in adults with papulopustular rosacea treated with doxycycline modified-release capsules in a randomized trial.,,2020,,['adults with papulopustular rosacea treated with'],['doxycycline modified-release capsules'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1449853', 'cui_str': 'Papulopustular Rosacea'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C4544813', 'cui_str': 'Modified-release'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}]",[],,0.075804,,"[{'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Friedman', 'Affiliation': 'Washington, District of Columbia. Electronic address: ajfriedman@mfa.gwu.edu.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.07.090']
3280,31604630,Nasal Intermittent Positive Pressure Ventilation Versus Nasal Continuous Positive Airway Pressure to Prevent Primary Noninvasive Ventilation Failure in Extremely Low Birthweight Infants.,"Reducing the risk of primary noninvasive ventilation failure in extremely low birthweight infants is linked to reducing bronchopulmonary dysplasia. In a secondary analysis of randomized data, we identified that failure rates and time to failure were similar for nasal intermittent positive pressure ventilation vs nasal continuous positive airway pressure.",2020,"In a secondary analysis of randomized data, we identified that failure rates and time to failure were similar for nasal intermittent positive pressure ventilation vs nasal continuous positive airway pressure.","['extremely low birthweight infants', 'Extremely Low Birthweight Infants']","['nasal intermittent positive pressure ventilation vs nasal continuous positive airway pressure', 'Nasal Intermittent Positive Pressure Ventilation Versus Nasal Continuous Positive Airway Pressure']",['failure rates and time to failure'],"[{'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0021778', 'cui_str': 'IPPV'}, {'cui': 'C1258045', 'cui_str': 'Nasal Continuous Positive Airway Pressure'}]","[{'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0940758,"In a secondary analysis of randomized data, we identified that failure rates and time to failure were similar for nasal intermittent positive pressure ventilation vs nasal continuous positive airway pressure.","[{'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Bourque', 'Affiliation': 'Section of Neonatology, Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO. Electronic address: stephanie.bourque@childrenscolorado.org.'}, {'ForeName': 'Robin S', 'Initials': 'RS', 'LastName': 'Roberts', 'Affiliation': 'Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Clyde J', 'Initials': 'CJ', 'LastName': 'Wright', 'Affiliation': 'Section of Neonatology, Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Haresh', 'Initials': 'H', 'LastName': 'Kirpalani', 'Affiliation': ""Division of Neonatology, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Lemyre', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Millar', 'Affiliation': 'Department of Neonatology, Royal Maternity Hospital, Belfast, United Kingdom.'}, {'ForeName': 'Nicolas A', 'Initials': 'NA', 'LastName': 'Bamat', 'Affiliation': ""Division of Neonatology, Children's Hospital of Philadelphia, Philadelphia, PA.""}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.08.064']
3281,31646365,Author's Reply: Prophylactic Intraperitoneal Onlay Mesh Following Midline Laparotomy: Long-Term Results of a Randomized Controlled Trial.,,2020,,['Midline Laparotomy'],['Prophylactic Intraperitoneal Onlay Mesh'],[],"[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal (qualifier value)'}, {'cui': 'C0677511', 'cui_str': 'Onlay (qualifier value)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}]",[],,0.0719582,,"[{'ForeName': 'Philippe M', 'Initials': 'PM', 'LastName': 'Glauser', 'Affiliation': 'Surgical Department, Spital Dornach, Spitalweg 11, 4143, Dornach, Switzerland. philippe.glauser@spital.so.ch.'}]",World journal of surgery,['10.1007/s00268-019-05245-y']
3282,31782961,Sleepiness as motivation: a potential mechanism for how sleep deprivation affects behavior.,"STUDY OBJECTIVES


To determine how sleepiness and sleep deprivation drive the motivation to engage in different behaviors.
METHODS


We studied the sleepiness of 123 participants who had been randomized to sleep deprivation or normal sleep, and their willingness to engage in a range of everyday behaviors.
RESULTS


Self-reported sleepiness was a strong predictor of the motivation to engage in sleep-preparatory behaviors such as shutting one's eyes (OR = 2.78, 95% CI: 2.19-3.52 for each step up on the Karolinska Sleepiness Scale) and resting (OR = 3.20, CI: 2.46-4.16). Sleepiness was also related to the desire to be cared for by a loved one (OR = 1.49, CI: 1.22-1.82), and preparedness to utilize monetary and energy resources to get to sleep. Conversely, increased sleepiness was associated with a decreased motivation for social and physical activities (e.g. be with friends OR = 0.71, CI: 0.61-0.82; exercise OR = 0.65, CI: 0.56-0.76). Sleep deprivation had similar effects as sleepiness on these behaviors. Neither sleepiness nor sleep deprivation had strong associations with hunger, thirst, or food preferences.
CONCLUSIONS


Our findings indicate that sleepiness is a dynamic motivational drive that promotes sleep-preparatory behaviors and competes with other drives and desired outcomes. Consequently, sleepiness may be a central mechanism by which impaired alertness, for example, due to insufficient sleep, contributes to poor quality of life and adverse health. We propose that sleepiness helps organize behaviors toward the specific goal of assuring sufficient sleep, in competition with other needs and incentives. A theoretical framework on sleepiness and its behavioral consequences are likely to improve our understanding of several disease mechanisms.",2020,"Sleepiness was also related to the desire to be cared for by a loved one (OR=1.49, CI: 1.22-1.82), and preparedness to utilize monetary and energy resources to get to sleep.","['123 participants who had been randomized to sleep deprivation or normal sleep, and their willingness to engage in a range of everyday behaviors']",[],"['Sleepiness as motivation', 'increased sleepiness', 'Sleepiness', 'motivation for social and physical activities']","[{'cui': 'C0037316', 'cui_str': 'Sleep Deprivation'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",[],"[{'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",123.0,0.0440609,"Sleepiness was also related to the desire to be cared for by a loved one (OR=1.49, CI: 1.22-1.82), and preparedness to utilize monetary and energy resources to get to sleep.","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Axelsson', 'Affiliation': 'Stress Research Institute, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ingre', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Göran', 'Initials': 'G', 'LastName': 'Kecklund', 'Affiliation': 'Stress Research Institute, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Lekander', 'Affiliation': 'Stress Research Institute, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Kenneth P', 'Initials': 'KP', 'LastName': 'Wright', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, CO.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Sundelin', 'Affiliation': 'Stress Research Institute, Stockholm University, Stockholm, Sweden.'}]",Sleep,['10.1093/sleep/zsz291']
3283,31707068,Intention-to-Treat Analyses for Randomized Controlled Trials in Hospice/Palliative Care: The Case for Analyses to be of People Exposed to the Intervention.,"CONTEXT


Minimizing bias in randomized controlled trials (RCTs) includes intention-to-treat analyses. Hospice/palliative care RCTs are constrained by high attrition unpredictable when consenting, including withdrawals between randomization and first exposure to the intervention. Such withdrawals may systematically bias findings away from the new intervention being evaluated if they are considered nonresponders.
OBJECTIVES


This study aimed to quantify the impact within intention-to-treat principles.
METHODS


A theoretical model was developed to assess the impact of withdrawals between randomization and first exposure on study power and effect sizes. Ten reported hospice/palliative care studies had power recalculated accounting for such withdrawal.
RESULTS


In the theoretical model, when 5% of withdrawals occurred between randomization and first exposure to the intervention, change in power was demonstrated in binary outcomes (2.0%-2.2%), continuous outcomes (0.8%-2.0%), and time-to-event outcomes (1.6%-2.0%), and odds ratios were changed by 0.06-0.17. Greater power loss was observed with larger effect sizes. Withdrawal rates were 0.9%-10% in the 10 reported RCTs, corresponding to power losses of 0.1%-2.2%. For studies with binary outcomes, withdrawal rates were 0.3%-1.2% changing odds ratios by 0.01-0.22.
CONCLUSION


If blinding is maintained and all interventions are available simultaneously, our model suggests that excluding data from withdrawals between randomization and first exposure to the intervention minimizes one bias. This is the safety population as defined by the International Committee on Harmonization. When planning for future trials, minimizing the time between randomization and first exposure to the intervention will minimize the problem. Power should be calculated on people who receive the intervention.",2020,"For studies with binary outcomes, withdrawal rates were 0.3%-1.2% changing odds ratios by 0.01-0.22.
",[],['Palliative Care'],"['withdrawal rates', 'Withdrawal rates', 'time-to-event outcomes']",[],"[{'cui': 'C0700049', 'cui_str': 'Palliative care'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",,0.0793362,"For studies with binary outcomes, withdrawal rates were 0.3%-1.2% changing odds ratios by 0.01-0.22.
","[{'ForeName': 'Slavica', 'Initials': 'S', 'LastName': 'Kochovska', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, New South Wales, Australia.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'The University of Hull, Hull, UK.'}, {'ForeName': 'Miriam J', 'Initials': 'MJ', 'LastName': 'Johnson', 'Affiliation': 'The University of Hull, Hull, UK; Wolfson Palliative Care Research Centre, University of Hull, Hull, UK.'}, {'ForeName': 'Meera R', 'Initials': 'MR', 'LastName': 'Agar', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, New South Wales, Australia.'}, {'ForeName': 'Marie T', 'Initials': 'MT', 'LastName': 'Fallon', 'Affiliation': 'Cancer Research UK Edinburgh Centre, MRC Institute of Genetics and Molecular Medicine, The University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Stein', 'Initials': 'S', 'LastName': 'Kaasa', 'Affiliation': 'Institute of Cancer Research and Molecular Medicine, Faculty of Medicine, Norwegian University of Science and Technology, Trondheim (NTNU), Trondheim, Norway.'}, {'ForeName': 'Jamilla A', 'Initials': 'JA', 'LastName': 'Hussain', 'Affiliation': 'Wolfson Palliative Care Research Centre, University of Hull, Hull, UK.'}, {'ForeName': 'Russell K', 'Initials': 'RK', 'LastName': 'Portenoy', 'Affiliation': 'MJHS Institute for Innovation in Palliative Care, MJHS Hospice and Palliative Care, New York, New York, USA.'}, {'ForeName': 'Irene J', 'Initials': 'IJ', 'LastName': 'Higginson', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy & Rehabilitation, King's College London, London, UK.""}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Currow', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, New South Wales, Australia; The University of Hull, Hull, UK; Wolfson Palliative Care Research Centre, University of Hull, Hull, UK. Electronic address: david.currow@uts.edu.au.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2019.10.026']
3284,31914436,Immunotherapy-Induced Airway Disease: A New Pattern of Lung Toxicity of Immune Checkpoint Inhibitors.,"Immune checkpoint inhibitors (ICIs) have been shown to improve overall and progression-free survival in various cancers but have been associated with various immune-related adverse events (IRAEs), including interstitial lung disease, especially organizing pneumonia. We report 2 cases of isolated severe airway disease attributable to ICIs, a rarely reported pattern of lung toxicity. The first patient received nivolumab with or without ipilimumab in a randomized double-blind trial for locoregional metastatic melanoma. The second patient was treated with nivolumab for lung adenocarcinoma. An IRAE was suspected in both cases due to a temporal relationship between ICI initiation and symptom onset. ICIs were stopped, and high-dose prednisone, inhaled corticosteroids, and bronchodilators were administered, allowing a rapid clinical and functional improvement in Patient 1. In Patient 2, despite prolonged high-dose prednisone, only a stabilization of forced expiratory volume in 1 s could be achieved, and the disease course was complicated by respiratory infections resulting in further loss of lung function. The patient died 1 year later due to progression of metastatic disease. These 2 cases suggest that pulmonary IRAEs secondary to ICIs may present as isolated bronchitis or bronchiolitis, with variable outcomes following ICI withdrawal and systemic corticosteroids.",2020,"Immune checkpoint inhibitors (ICIs) have been shown to improve overall and progression-free survival in various cancers but have been associated with various immune-related adverse events (IRAEs), including interstitial lung disease, especially organizing pneumonia.",['Immunotherapy-Induced Airway Disease'],"['nivolumab', 'prednisone', 'nivolumab with or without ipilimumab', 'Immune checkpoint inhibitors (ICIs']",[],"[{'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]",[],,0.0967756,"Immune checkpoint inhibitors (ICIs) have been shown to improve overall and progression-free survival in various cancers but have been associated with various immune-related adverse events (IRAEs), including interstitial lung disease, especially organizing pneumonia.","[{'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Mitropoulou', 'Affiliation': 'Respiratory Medicine Department, Lausanne University Hospital (CHUV), Lausanne, Switzerland.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Daccord', 'Affiliation': 'Respiratory Medicine Department, Lausanne University Hospital (CHUV), Lausanne, Switzerland, cecile.daccord@chuv.ch.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Sauty', 'Affiliation': 'Division ofRespiratory Medicine, Cantonal Hospital, Neuchâtel, Switzerland.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Pasche', 'Affiliation': 'Division of Respiratory Medicine, Morges Hospital - EHC, Morges, Switzerland.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Egger', 'Affiliation': 'Center of Respiratory Medicine and Pulmonary Rehabilitation, Rolle Hospital - GHOL, Rolle, Switzerland.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Aedo Lopez', 'Affiliation': 'Department of Medical Oncology, Lausanne University Hospital (CHUV), Lausanne, Switzerland.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Letovanec', 'Affiliation': 'Institute of Pathology, Lausanne University Hospital (CHUV), Lausanne, Switzerland.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Beigelman-Aubry', 'Affiliation': 'Radiodiagnostic and Interventional Radiology, Lausanne University Hospital (CHUV), Lausanne, Switzerland.'}, {'ForeName': 'Laurent P', 'Initials': 'LP', 'LastName': 'Nicod', 'Affiliation': 'Respiratory Medicine Department, Lausanne University Hospital (CHUV), Lausanne, Switzerland.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Lazor', 'Affiliation': 'Respiratory Medicine Department, Lausanne University Hospital (CHUV), Lausanne, Switzerland.'}]",Respiration; international review of thoracic diseases,['10.1159/000504968']
3285,32067251,Randomized Controlled Trial of a Multilevel Intervention to Address Social Determinants of Refugee Mental Health.,"Understanding processes that support the well-being of the unprecedented numbers of forcibly displaced people throughout the world is essential. Growing evidence documents post-migration stressors related to marginalization as key social determinants of refugee mental health. The goal of this RCT was to rigorously test a social justice approach to reducing high rates of distress among refugees in the United States. The 6-month multilevel, strengths-based Refugee Well-being Project (RWP) intervention brought together university students enrolled in a 2-semester course and recently resettled refugees to engage in mutual learning and collaborative efforts to mobilize community resources and improve community and systems responsiveness to refugees. Data collected from 290 Afghan, Great Lakes African, Iraqi, and Syrian refugees at four time points over 12 months were used to test the effectiveness of RWP to reduce distress (depression and anxiety symptoms) and increase protective factors (English proficiency, social support, connection to home and American cultures). Intention-to-treat analyses using multilevel modeling revealed significant intervention effects for all hypothesized outcomes. Results provide evidence to support social justice approaches to improving refugee mental health. Findings have implications for refugees worldwide, and for other immigrant and marginalized populations who experience inequities in resources and disproportionate exposure to trauma/stress.",2020,Understanding processes that support the well-being of the unprecedented numbers of forcibly displaced people throughout the world is essential.,[],"['RWP', 'strengths-based Refugee Well-being Project (RWP) intervention', 'Multilevel Intervention']","['protective factors (English proficiency, social support, connection to home and American cultures', 'distress (depression and anxiety symptoms']",[],"[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}]","[{'cui': 'C0679688', 'cui_str': 'Protective Factors'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0037438'}, {'cui': 'C0449379', 'cui_str': 'Connection (attribute)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",,0.0395065,Understanding processes that support the well-being of the unprecedented numbers of forcibly displaced people throughout the world is essential.,"[{'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Goodkind', 'Affiliation': 'Department of Sociology, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Bybee', 'Affiliation': 'Department of Psychology, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Julia Meredith', 'Initials': 'JM', 'LastName': 'Hess', 'Affiliation': 'Department of Pediatrics, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Suha', 'Initials': 'S', 'LastName': 'Amer', 'Affiliation': 'Center for Social Policy, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Ndayisenga', 'Affiliation': 'Center for Social Policy, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'R Neil', 'Initials': 'RN', 'LastName': 'Greene', 'Affiliation': 'Department of Sociology, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Ryeora', 'Initials': 'R', 'LastName': 'Choe', 'Affiliation': 'Department of Sociology, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Isakson', 'Affiliation': 'Department of Psychiatry, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Baca', 'Affiliation': 'Center for Social Policy, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Mahbooba', 'Initials': 'M', 'LastName': 'Pannah', 'Affiliation': 'Center for Social Policy, University of New Mexico, Albuquerque, NM, USA.'}]",American journal of community psychology,['10.1002/ajcp.12418']
3286,31918936,Reply: Percutaneous Intervention in Bifurcations After the DKCRUSH-V Trial: Case Closed?,,2020,,[],[],[],[],[],[],,0.0347958,,"[{'ForeName': 'Shao-Liang', 'Initials': 'SL', 'LastName': 'Chen', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.11.014']
3287,31918935,Percutaneous Intervention in Bifurcations After the DKCRUSH-V Trial: Case Closed?,,2020,,[],['Percutaneous Intervention'],[],[],"[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}]",[],,0.036682,,"[{'ForeName': 'Iñigo', 'Initials': 'I', 'LastName': 'Lozano', 'Affiliation': ''}, {'ForeName': 'Jose Miguel', 'Initials': 'JM', 'LastName': 'Vegas', 'Affiliation': ''}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Rondan', 'Affiliation': ''}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Segovia', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.10.055']
3288,30815685,Original Antigenic Sin Shapes the Immunological Repertoire Evoked by Human Cytomegalovirus Glycoprotein B/MF59 Vaccine in Seropositive Recipients.,"A human cytomegalovirus (HCMV) vaccine is urgently needed to protect against primary infection and enhance existing immunity in HCMV-infected individuals (HCMV+). Using sera from HCMV+ glycoprotein B/MF59 vaccine recipients prior to transplant, we investigated the composition of the immune response. Vaccination boosted preexisting humoral responses in our HCMV+ cohort but did not promote de novo responses against novel linear epitopes. This suggests that prior natural infection has a profound effect on shaping the antibody repertoire and subsequent response to vaccination (""original antigenic sin""). Thus, vaccination of HCMV+ may require strategies of epitope presentation distinct from those intended to prevent primary infection.",2019,Vaccination boosted preexisting humoral responses in our HCMV+ cohort but did not promote de novo responses against novel linear epitopes.,['Seropositive Recipients'],['Human Cytomegalovirus Glycoprotein B/MF59 Vaccine'],[],"[{'cui': 'C0521143', 'cui_str': 'Seropositive (qualifier value)'}]","[{'cui': 'C0205725', 'cui_str': 'Human Herpesvirus 5 species'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0289787', 'cui_str': 'MF59'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]",[],,0.0259795,Vaccination boosted preexisting humoral responses in our HCMV+ cohort but did not promote de novo responses against novel linear epitopes.,"[{'ForeName': 'Ilona', 'Initials': 'I', 'LastName': 'Baraniak', 'Affiliation': 'Institute for Immunity and Transplantation, University College London, United Kingdom.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Kern', 'Affiliation': 'Clinical and Experimental Medicine, Brighton and Sussex Medical School, United Kingdom.'}, {'ForeName': 'Pavlo', 'Initials': 'P', 'LastName': 'Holenya', 'Affiliation': 'JPT Peptide Technologies GmbH, Berlin, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Griffiths', 'Affiliation': 'Institute for Immunity and Transplantation, University College London, United Kingdom.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Reeves', 'Affiliation': 'Institute for Immunity and Transplantation, University College London, United Kingdom.'}]",The Journal of infectious diseases,['10.1093/infdis/jiz089']
3289,31973633,Non-invasive home telemonitoring system for heart failure patients: A randomized clinical trial.,"INTRODUCTION


The low quality of life in heart failure patients is related to low self-care and treatment adherence. Consequently, innovative strategies are needed to improve them. The objective of this work is to determine the effectiveness of the use of a home telemonitoring system to improve the self-care and treatment adherence of heart failure patients.
METHODS


A randomized clinical trial that compares the efficacy of a home telemonitoring system -intervention group versus usual care control group - among heart failure outpatients over a 90-day monitoring period was carried out. The home telemonitoring system consists of an application that collects measurements of different parameters on a daily basis and provides health education to patients. The home telemonitoring system processes data gathered and generates an alert if a risky situation arises. The outcomes observed were significant changes in patients' self-care (European Heart Failure Self-care Behaviour Scale), treatment adherence (Morisky Modified Scale) and re-hospitalizations over the follow-up period.
RESULTS


104 heart failure patients were screened; 40 met the inclusion criteria; only 30 completed the study. After the follow-up, intragroup analysis of the control group indicated a decrease in treatment adherence ( p  = 0.02). The mean European Heart Failure Self-care Behaviour Scale overall score indicated an improved self-care in the intervention group patients ( p  = 0.03) and a worsened self-care in the control group ( p  = 0.04) with a  p  value of 0.004 in the intergroup analysis. Thanks to the home telemonitoring system alerts, two re-hospitalizations were avoided.
DISCUSSION


This study demonstrated that the proposed home telemonitoring system improves patient self-care when compared to usual care and has the potential to avoid re-hospitalizations, even considering patients with low literacy levels.  Trial Registration:  Home Telemonitoring System for Patients with Heart Failure. clinicaltrials.gov Identifier: NCT04071093.",2020,,['heart failure patients'],[],[],"[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],[],,0.115568,,"[{'ForeName': 'Lucía M', 'Initials': 'LM', 'LastName': 'Yanicelli', 'Affiliation': 'Instituto de Desarrollo y Diseño, CONICET & Universidad Tecnológica Nacional, Argentina.'}, {'ForeName': 'Carla B', 'Initials': 'CB', 'LastName': 'Goy', 'Affiliation': 'Laboratorio de Medios e Interfases, Universidad Nacional de Tucumán, Argentina.'}, {'ForeName': 'Viviana Del C', 'Initials': 'VDC', 'LastName': 'González', 'Affiliation': 'Hospital Centro de Salud Zenón J Santillán, Argentina.'}, {'ForeName': 'Gerardo N', 'Initials': 'GN', 'LastName': 'Palacios', 'Affiliation': 'Hospital Centro de Salud Zenón J Santillán, Argentina.'}, {'ForeName': 'Ernesto C', 'Initials': 'EC', 'LastName': 'Martínez', 'Affiliation': 'Instituto de Desarrollo y Diseño, CONICET & Universidad Tecnológica Nacional, Argentina.'}, {'ForeName': 'Myriam C', 'Initials': 'MC', 'LastName': 'Herrera', 'Affiliation': 'Laboratorio de Investigaciones Cardiovasculares Multidisciplinarias, Universidad Nacional de Tucumán, Argentina.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19899261']
3290,32198802,A Phase 2a Trial Investigating the Safety and Tolerability of the Novel Cortical Enhancer IRL752 in Parkinson's Disease Dementia.,"BACKGROUND


IRL752 is a novel small-molecule compound that acts to regioselectively enhance norepinephrine, dopamine, and acetylcholine neurotransmission in the cerebral cortex.
OBJECTIVE


The primary objective of the trial was to investigate the safety and tolerability of IRL752 in patients with Parkinson's disease and dementia.
METHODS


Patients with Parkinson's disease and dementia were randomized to IRL752 or placebo treatment (3:1 ratio) for 28 days. The study drug was given as an adjunct treatment to the patients' regular stable antiparkinsonian medication. Dosing was individually titrated for 14 days after which the dose was kept stable for an additional 14 days.
RESULTS


A total of 32 patients were randomized to treatment, and 29 patients completed the 4-week treatment. Adverse events were generally mild and transient and were mostly reported during the dose titration phase. There were 2 serious adverse events, and none of them were related to the experimental treatment. The average dose achieved in the stable dose phase was 600 mg daily, yielding a 2-hour postdose plasma concentration of about 4 μM on day 28. Exploratory assessment of secondary outcomes indicated efficacy for symptoms and signs known to be poorly responsive to levodopa.
CONCLUSIONS


IRL752 appears to be safe and well tolerated for a 4-week treatment in patients with Parkinson's disease and dementia. © 2020 International Parkinson and Movement Disorder Society.",2020,"There were 2 serious adverse events, and none of them were related to the experimental treatment.","[""Parkinson's Disease Dementia"", ""patients with Parkinson's disease and dementia"", ""patients' regular stable antiparkinsonian medication"", ""Patients with Parkinson's disease and dementia"", '32 patients']","['Novel Cortical Enhancer IRL752', 'IRL752', 'IRL752 or placebo']","['Adverse events', 'safety and tolerability', 'Safety and Tolerability', 'serious adverse events', 'safe and well tolerated']","[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0003405', 'cui_str': 'Antiparkinsonians'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",32.0,0.0512868,"There were 2 serious adverse events, and none of them were related to the experimental treatment.","[{'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Svenningsson', 'Affiliation': 'Section of Neurology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Odin', 'Affiliation': 'Division of Neurology, Department of Clinical Sciences Lund, Lund University, Lund, Sweden.'}, {'ForeName': 'Nil', 'Initials': 'N', 'LastName': 'Dizdar', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Johansson', 'Affiliation': 'Section of Neurology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Sotirios', 'Initials': 'S', 'LastName': 'Grigoriou', 'Affiliation': 'Division of Neurology, Department of Clinical Sciences Lund, Lund University, Lund, Sweden.'}, {'ForeName': 'Panagiota', 'Initials': 'P', 'LastName': 'Tsitsi', 'Affiliation': 'Section of Neurology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Klas', 'Initials': 'K', 'LastName': 'Wictorin', 'Affiliation': 'Department of Neurology, Helsingborg Hospital, Helsingborg, Sweden.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Bergquist', 'Affiliation': 'Department of Pharmacology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Dag', 'Initials': 'D', 'LastName': 'Nyholm', 'Affiliation': 'Department of Neuroscience, Neurology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Rinne', 'Affiliation': 'Clinical Research Services Turku Oy, Turku, Finland.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Hansson', 'Affiliation': 'Clinical Trial Consultants, Uppsala, Sweden.'}, {'ForeName': 'Clas', 'Initials': 'C', 'LastName': 'Sonesson', 'Affiliation': 'Integrative Research Laboratories AB, Göteborg, Sweden.'}, {'ForeName': 'Joakim', 'Initials': 'J', 'LastName': 'Tedroff', 'Affiliation': 'Section of Neurology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.28020']
3291,31047791,Adaptive Tutorials Versus Web-Based Resources in Radiology: A Mixed Methods Analysis of Efficacy and Engagement in Senior Medical Students.,"RATIONALE AND OBJECTIVES


Radiology education is suited to delivery via e-learning which may be used to fill gaps in knowledge and help prepare medical students for internship. There is limited evidence of effectiveness of adaptive tutorials, a form of e-learning in a senior medical student cohort.
MATERIALS AND METHODS


A randomized mixed methods crossover trial was performed to assess effectiveness of adaptive tutorials on engagement and understanding of appropriate use and interpretation of basic imaging studies. Eighty-one volunteer medical students from years 5 and 6 of a 6-year program were randomly allocated to one of two groups. In the first phase of the trial on head CT, one group received access to adaptive tutorials and the other to peer-reviewed web-based resources. A cross over was performed and the second phase of the trial addressing chest CT commenced. Examination style assessments were completed at the end of each phase. At the trial's conclusion, an online questionnaire was provided to evaluate student perceptions of engagement and efficacy of each educational resource.
RESULTS


Adaptive tutorial groups in both phases achieved higher mean scores than controls which were statistically significant in the first phase only. Students reported higher engagement and overall perceived value of the adaptive tutorials than controls.
CONCLUSION


Adaptive tutorials are overwhelmingly supported by senior medical students. Questionnaire responses suggest the engaging nature of the tutorials efficiently aids participation and knowledge retention which is in principle supported by test results.",2019,Questionnaire responses suggest the engaging nature of the tutorials efficiently aids participation and knowledge retention which is in principle supported by test results.,"['Eighty-one volunteer medical students from years 5 and 6 of a 6-year program', 'senior medical students', 'Radiology', 'Senior Medical Students']",[],"['Examination style assessments', 'mean scores']","[{'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0034599', 'cui_str': 'Radiology'}]",[],"[{'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",81.0,0.0548539,Questionnaire responses suggest the engaging nature of the tutorials efficiently aids participation and knowledge retention which is in principle supported by test results.,"[{'ForeName': 'Stuart W T', 'Initials': 'SWT', 'LastName': 'Wade', 'Affiliation': 'Prince of Wales Hospital, Sydney, Australia; School of Medical Sciences, Faculty of Medicine, The University of New South Wales, Kensington, Sydney 2052, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Moscova', 'Affiliation': 'School of Medical Sciences, Faculty of Medicine, The University of New South Wales, Kensington, Sydney 2052, Australia.'}, {'ForeName': 'Nicodemus', 'Initials': 'N', 'LastName': 'Tedla', 'Affiliation': 'School of Medical Sciences, Faculty of Medicine, The University of New South Wales, Kensington, Sydney 2052, Australia.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Moses', 'Affiliation': 'Prince of Wales Hospital, Sydney, Australia; Prince of Wales Clinical School, Faculty of Medicine, The University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Noel', 'Initials': 'N', 'LastName': 'Young', 'Affiliation': 'Westmead Hospital, Sydney, Australia.'}, {'ForeName': 'Merribel', 'Initials': 'M', 'LastName': 'Kyaw', 'Affiliation': 'Royal Prince Alfred Hospital, Sydney, Australia.'}, {'ForeName': 'Gary M', 'Initials': 'GM', 'LastName': 'Velan', 'Affiliation': 'School of Medical Sciences, Faculty of Medicine, The University of New South Wales, Kensington, Sydney 2052, Australia. Electronic address: g.velan@unsw.edu.au.'}]",Academic radiology,['10.1016/j.acra.2019.02.021']
3292,32107101,Lack of ECT effects on clozapine plasma levels in patients with treatment-resistant schizophrenia: Pharmacokinetic evidence from a randomized clinical trial.,,2020,,['patients with treatment-resistant schizophrenia'],[],['clozapine plasma levels'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3544321', 'cui_str': 'Treatment-resistant schizophrenia'}]",[],"[{'cui': 'C0009079', 'cui_str': 'Clozapine'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.268407,,"[{'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Schoretsanitis', 'Affiliation': 'The Zucker Hillside Hospital, Psychiatry Research, Northwell Health, Glen Oaks, NY, USA. Electronic address: george.schor@gmail.com.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Mendelowitz', 'Affiliation': 'The Zucker Hillside Hospital, Psychiatry Research, Northwell Health, Glen Oaks, NY, USA; The Hofstra Northwell School of Medicine, Hempstead, NY, USA; The Feinstein Institute for Medical Research, Manhasset, NY, USA.'}, {'ForeName': 'Chitra', 'Initials': 'C', 'LastName': 'Malur', 'Affiliation': 'The Zucker Hillside Hospital, Psychiatry Research, Northwell Health, Glen Oaks, NY, USA; The Hofstra Northwell School of Medicine, Hempstead, NY, USA; The Feinstein Institute for Medical Research, Manhasset, NY, USA.'}, {'ForeName': 'Raphael J', 'Initials': 'RJ', 'LastName': 'Braga', 'Affiliation': 'The Zucker Hillside Hospital, Psychiatry Research, Northwell Health, Glen Oaks, NY, USA; The Hofstra Northwell School of Medicine, Hempstead, NY, USA; The Feinstein Institute for Medical Research, Manhasset, NY, USA.'}, {'ForeName': 'Nina R', 'Initials': 'NR', 'LastName': 'Schooler', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, SUNY Downstate Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Majnu', 'Initials': 'M', 'LastName': 'John', 'Affiliation': 'The Zucker Hillside Hospital, Psychiatry Research, Northwell Health, Glen Oaks, NY, USA; The Hofstra Northwell School of Medicine, Hempstead, NY, USA; The Feinstein Institute for Medical Research, Manhasset, NY, USA.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'de Leon', 'Affiliation': 'University of Kentucky Mental Health Research Center at Eastern State Hospital, Lexington, KY, USA; Psychiatry and Neurosciences Research Group (CTS-549), Institute of Neurosciences, University of Granada, Granada, Spain; Biomedical Research Centre in Mental Health Net (CIBERSAM), Santiago Apostol Hospital, University of the Basque Country, Vitoria, Spain.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kane', 'Affiliation': 'The Zucker Hillside Hospital, Psychiatry Research, Northwell Health, Glen Oaks, NY, USA; The Hofstra Northwell School of Medicine, Hempstead, NY, USA; The Feinstein Institute for Medical Research, Manhasset, NY, USA.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Petrides', 'Affiliation': 'The Zucker Hillside Hospital, Psychiatry Research, Northwell Health, Glen Oaks, NY, USA; The Hofstra Northwell School of Medicine, Hempstead, NY, USA; The Feinstein Institute for Medical Research, Manhasset, NY, USA.'}]",Schizophrenia research,['10.1016/j.schres.2020.02.008']
3293,31988276,White blood cell and cell-free DNA analyses for detection of residual disease in gastric cancer.,"Liquid biopsies are providing new opportunities for detection of residual disease in cell-free DNA (cfDNA) after surgery but may be confounded through identification of alterations arising from clonal hematopoiesis. Here, we identify circulating tumor-derived DNA (ctDNA) alterations through ultrasensitive targeted sequencing analyses of matched cfDNA and white blood cells from the same patient. We apply this approach to analyze samples from patients in the CRITICS trial, a phase III randomized controlled study of perioperative treatment in patients with operable gastric cancer. After filtering alterations from matched white blood cells, the presence of ctDNA predicts recurrence when analyzed within nine weeks after preoperative treatment and after surgery in patients eligible for multimodal treatment. These analyses provide a facile method for distinguishing ctDNA from other cfDNA alterations and highlight the utility of ctDNA as a predictive biomarker of patient outcome to perioperative cancer therapy and surgical resection in patients with gastric cancer.",2020,"After filtering alterations from matched white blood cells, the presence of ctDNA predicts recurrence when analyzed within nine weeks after preoperative treatment and after surgery in patients eligible for multimodal treatment.","['gastric cancer', 'patients with gastric cancer', 'patients with operable gastric cancer']",[],[],"[{'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205188', 'cui_str': 'Operable (qualifier value)'}]",[],[],,0.0542167,"After filtering alterations from matched white blood cells, the presence of ctDNA predicts recurrence when analyzed within nine weeks after preoperative treatment and after surgery in patients eligible for multimodal treatment.","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Leal', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Nicole C T', 'Initials': 'NCT', 'LastName': 'van Grieken', 'Affiliation': 'Department of Pathology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands.'}, {'ForeName': 'Doreen N', 'Initials': 'DN', 'LastName': 'Palsgrove', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Phallen', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Jamie E', 'Initials': 'JE', 'LastName': 'Medina', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Hruban', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Mark A M', 'Initials': 'MAM', 'LastName': 'Broeckaert', 'Affiliation': 'Department of Pathology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands.'}, {'ForeName': 'Valsamo', 'Initials': 'V', 'LastName': 'Anagnostou', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Vilmos', 'Initials': 'V', 'LastName': 'Adleff', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Bruhm', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Jenna V', 'Initials': 'JV', 'LastName': 'Canzoniero', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Fiksel', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Nordsmark', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Fabienne A R M', 'Initials': 'FARM', 'LastName': 'Warmerdam', 'Affiliation': 'Department of Medical Oncology, Zuyderland Medical Centre, Sittard-Geleen/Heerlen, Netherlands.'}, {'ForeName': 'Henk M W', 'Initials': 'HMW', 'LastName': 'Verheul', 'Affiliation': 'Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands.'}, {'ForeName': 'Dick Johan', 'Initials': 'DJ', 'LastName': 'van Spronsen', 'Affiliation': 'Department of Hematology, Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'Laurens V', 'Initials': 'LV', 'LastName': 'Beerepoot', 'Affiliation': 'Department of Internal Medicine, St. Elisabeth-Tweesteden Ziekenhuis, Tilburg, Netherlands.'}, {'ForeName': 'Maud M', 'Initials': 'MM', 'LastName': 'Geenen', 'Affiliation': 'Department of Internal Medicine, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands.'}, {'ForeName': 'Johanneke E A', 'Initials': 'JEA', 'LastName': 'Portielje', 'Affiliation': 'Department of Internal Medicine, HAGA hospital, The Hague, Netherlands.'}, {'ForeName': 'Edwin P M', 'Initials': 'EPM', 'LastName': 'Jansen', 'Affiliation': 'Department of Radiation Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'van Sandick', 'Affiliation': 'Department of Surgery, Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Elma', 'Initials': 'E', 'LastName': 'Meershoek-Klein Kranenbarg', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Hanneke W M', 'Initials': 'HWM', 'LastName': 'van Laarhoven', 'Affiliation': 'Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Amsterdam, Netherlands.'}, {'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'van der Peet', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands.'}, {'ForeName': 'Cornelis J H', 'Initials': 'CJH', 'LastName': 'van de Velde', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Verheij', 'Affiliation': 'Department of Radiation Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Remond', 'Initials': 'R', 'LastName': 'Fijneman', 'Affiliation': 'Department of Pathology, Diagnostic Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Scharpf', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Gerrit A', 'Initials': 'GA', 'LastName': 'Meijer', 'Affiliation': 'Department of Pathology, Diagnostic Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Annemieke', 'Initials': 'A', 'LastName': 'Cats', 'Affiliation': 'Department of Gastrointestinal Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Victor E', 'Initials': 'VE', 'LastName': 'Velculescu', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA. velculescu@jhmi.edu.'}]",Nature communications,['10.1038/s41467-020-14310-3']
3294,28368681,Does change in readiness influence retention among African American women and men in substance abuse treatment?,"African Americans are less likely than other racial groups to engage in and complete outpatient substance abuse treatment. The current study, conducted as a secondary analysis of a multisite randomized clinical trial, examined whether readiness to change (RTC) over time influences retention and whether gender moderates the relationship between changes in RTC and retention among 194 African American women and men. Participants completed the University of Rhode Island Change Assessment at baseline and at the end of the 16-week study. Findings revealed a significant relationship between RTC over time and retention. Specifically, the more RTC increased throughout the 16-week study, the longer participants remained in treatment. In addition, gender moderated the relationship between changes in RTC and retention, with a stronger association between changes in RTC and retention among men relative to women. One approach to improving substance abuse treatment retention rates is to focus on increasing RTC during treatment, especially among African American men.",2017,African Americans are less likely than other racial groups to engage in and complete outpatient substance abuse treatment.,"['African Americans', 'African American men', 'African American women and men in substance abuse treatment', '194 African American women and men']",[],['RTC'],"[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0740858', 'cui_str': 'Substance Abuse'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],[],194.0,0.0191784,African Americans are less likely than other racial groups to engage in and complete outpatient substance abuse treatment.,"[{'ForeName': 'LaTrice', 'Initials': 'L', 'LastName': 'Montgomery', 'Affiliation': 'a University of Cincinnati , Cincinnati , Ohio.'}, {'ForeName': 'A Kathleen', 'Initials': 'AK', 'LastName': 'Burlew', 'Affiliation': 'a University of Cincinnati , Cincinnati , Ohio.'}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Korte', 'Affiliation': 'b Medical University of South Carolina , Charleston , South Carolina.'}]",Journal of ethnicity in substance abuse,['10.1080/15332640.2017.1300553']
3295,32133585,Baseline-dependent effect of dopamine's precursor L-tyrosine on working memory gating but not updating.,"Adaptive goal-directed behavior requires a dynamic balance between maintenance and updating within working memory (WM). This balance is controlled by an input-gating mechanism implemented by dopamine in the basal ganglia. Given that dopaminergic manipulations can modulate performance on WM-related tasks, it is important to gain mechanistic insight into whether such manipulations differentially affect updating (i.e., encoding and removal) and the closely-related gate opening/closing processes that respectively enable/prevent updating. To clarify this issue, 2.0 g of dopamine's precursor L-tyrosine was administered to healthy young adults (N = 45) in a double-blind, placebo-controlled, within-subjects study. WM processes were empirically distinguished using the reference-back paradigm, which isolates performance related to updating, gate opening, and gate closing. L-tyrosine had a selective, baseline-dependent effect only on gate opening, which was evidenced by markedly reduced variance across subjects in gate opening performance in the L-tyrosine compared with the placebo condition, whereas the whole-sample average performance did not differ between conditions. This indicates a pattern of results whereby low-performing subjects improved, whereas high-performing subjects were impaired on L-tyrosine. Importantly, this inverted U-shaped pattern was not explained by regression to the mean. These results are consistent with an inverted-U relationship between dopamine and WM, and they indicate that updating and gating are differentially affected by a dopaminergic manipulation. This highlights the importance of distinguishing these processes when studying WM, for example, in the context of WM deficits in disorders with a dopaminergic pathophysiology.",2020,"L-tyrosine had a selective, baseline-dependent effect only on gate opening, which was evidenced by markedly reduced variance across subjects in gate opening performance in the L-tyrosine compared with the placebo condition, whereas the whole-sample average performance did not differ between conditions.",['healthy young adults (N = 45'],"['placebo', 'dopaminergic manipulations', ""dopamine's precursor L-tyrosine""]",[],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0041485', 'cui_str': 'L-tyrosine'}]",[],45.0,0.0628613,"L-tyrosine had a selective, baseline-dependent effect only on gate opening, which was evidenced by markedly reduced variance across subjects in gate opening performance in the L-tyrosine compared with the placebo condition, whereas the whole-sample average performance did not differ between conditions.","[{'ForeName': 'Bryant J', 'Initials': 'BJ', 'LastName': 'Jongkees', 'Affiliation': 'Institute of Psychology & Leiden Institute for Brain and Cognition, Leiden University, Wassenaarseweg 52, 2333AK, Leiden, the Netherlands. b.j.jongkees@fsw.leidenuniv.nl.'}]","Cognitive, affective & behavioral neuroscience",['10.3758/s13415-020-00783-8']
3296,30374191,Opioid system modulation with buprenorphine/samidorphan combination for major depressive disorder: two randomized controlled studies.,"The endogenous opioid system is thought to play an important role in the regulation of mood. Buprenorphine/samidorphan (BUP/SAM) combination is an investigational opioid system modulator for adjunctive treatment of major depressive disorder (MDD). To confirm results from early studies, we report the efficacy and safety of BUP/SAM as adjunctive treatment in patients with MDD and an inadequate response to antidepressant therapy (ADT) in FORWARD-4 and FORWARD-5: two phase 3, randomized, double-blind, placebo-controlled studies that utilized the same sequential parallel-comparison design. Efficacy was measured using the Montgomery-Åsberg Depression Rating Scale (MADRS). FORWARD-5 achieved the primary endpoint and demonstrated that adjunctive BUP/SAM 2 mg/2 mg was superior to placebo (average difference change from baseline to week 3 through end of treatment [EOT] in MADRS-6 and -10 versus placebo: -1.5, P = 0.018; -1.9, P = 0.026, respectively). FORWARD-4 did not achieve the primary endpoint (change from baseline in MADRS-10 at week 5 versus placebo: -1.8, P = 0.109), although separate analyses showed significant treatment differences at other timepoints using traditional, regulatory-accepted endpoints such as reduction in MADRS-10 at EOT. The pooled analysis of the two studies demonstrated consistently greater reduction in MADRS-10 scores from baseline for BUP/SAM 2 mg/2 mg versus placebo at multiple timepoints including EOT and average change from baseline to week 3 through EOT (-1.8, P = 0.010; -1.8, P = 0.004, respectively). The overall effect size (Hedges' g) in the pooled analyses for MADRS-10 change from baseline to EOT was 0.22. Overall, BUP/SAM was generally well tolerated, with most adverse events (AEs) being mild or moderate in severity. The most common AEs, occurring in ≥5% of patients in the BUP/SAM 2 mg/2 mg treatment group, which was more frequently than the placebo group, included nausea, constipation, dizziness, vomiting, somnolence, fatigue, and sedation. There was minimal evidence of abuse, and no evidence of dependence or opioid withdrawal by AEs or objective measures. This report describes adjunctive BUP/SAM 2 mg/2 mg combination, a therapy with a novel opioidergic mechanism of action, as a potential new treatment option for patients with MDD who have an inadequate response to currently available ADT.",2020,,['major depressive disorder'],['buprenorphine/samidorphan combination'],[],"[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C4277369', 'cui_str': '3-carboxamido-4-hydroxynaltrexone'}]",[],,0.231079,,"[{'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (CTNI), Harvard Medical School, Boston, MA, USA. MFAVA@mgh.harvard.edu.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine and the Corporal Michael Crescenz Veterans Affairs Medical Center, Philadelphia, PA, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Ehrich', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Martin', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Asli', 'Initials': 'A', 'LastName': 'Memisoglu', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Narinder', 'Initials': 'N', 'LastName': 'Nangia', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Arielle D', 'Initials': 'AD', 'LastName': 'Stanford', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Pathak', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}]",Molecular psychiatry,['10.1038/s41380-018-0284-1']
3297,31898768,"Comparison of Electroacupuncture and Body Acupuncture on Gastrocnemius Muscle Tone in Children with Spastic Cerebral Palsy: A Single Blinded, Randomized Controlled Pilot Trial.","OBJECTIVE


To compare the immediate effects of electroacupuncture (EA) and body acupuncture (BA) on gastrocnemius muscle tone in children with spastic cerebral palsy (CP).
METHODS


Children with spastic CP, age from 24 to 60 months, who all received rehabilitation treatment in the Department of Developmental and Behavioral Pediatrics, the First Hospital of Jilin University from April 2016 to May 2017 were enrolled in this trial and assigned to EA group and BA group through a random number table. Both EA and BA therapies were performed on acupoints of Zusanli (ST 36), Shangjuxu (ST 37), Sanyinjiao (SP 6), and Xuanzhong (GB 39) for 30 min once. The root mean square (RMS), integrated electromyogram (iEMG) of the gastrocnemius of surface electromyography (sEMG), and Modified Tardieu Scale (MTS) of the two groups were evaluated before and after treatment. All adverse events were accurately recorded.
RESULTS


Thirty-six children with spastic CP completed the study (18 cases and 32 legs in the EA group; 18 cases and 31 legs in the BA group). There was no significant difference in RMS, iEMG and MTS between the two groups before treatment (P>0.05). After treatment, compared with before treatment, RMS and iEMG significantly reduced and MTS (R2-R1) significantly increased in both EA and BA groups (P<0.05), and EA was more effective than BA in RMS and MTS (P<0.05). However, the iEMG between the two groups were not statistically significant after treatment (P>0.05). There was no serious adverse event during this clinical trial.
CONCLUSION


Both EA and BA could significantly relieve the gastrocnemius muscle tone in spastic CP, and EA was more effective than BA. (Registration No. ChiCTRONC-15007633).",2020,"There was no significant difference in RMS, iEMG and MTS between the two groups before treatment (P>0.05).","['Children with spastic CP, age from 24 to 60 months, who all received rehabilitation treatment in the Department of Developmental and Behavioral Pediatrics, the First Hospital of Jilin University from April 2016 to May 2017 were enrolled in this trial and assigned to EA group and BA group through a random number table', 'Thirty-six children with spastic CP completed the study (18 cases and 32 legs in the EA group; 18 cases and 31 legs in the BA group', 'Children with Spastic Cerebral Palsy', 'children with spastic cerebral palsy (CP']","['Electroacupuncture and Body Acupuncture', 'electroacupuncture (EA) and body acupuncture (BA']","['RMS, iEMG and MTS', 'gastrocnemius muscle tone', 'root mean square (RMS), integrated electromyogram (iEMG) of the gastrocnemius of surface electromyography (sEMG), and Modified Tardieu Scale (MTS', 'Gastrocnemius Muscle Tone', 'MTS (R2-R1']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0443306', 'cui_str': 'Spastic'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0458003', 'cui_str': 'Developmental (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1706074', 'cui_str': 'Table'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy (disorder)'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0242691', 'cui_str': 'Gastrocnemius Muscle'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0430815', 'cui_str': 'Surface Electromyography'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0222045'}]",36.0,0.0460213,"There was no significant difference in RMS, iEMG and MTS between the two groups before treatment (P>0.05).","[{'ForeName': 'Li-Li', 'Initials': 'LL', 'LastName': 'Wang', 'Affiliation': 'Department of Developmental and Behavioral Pediatrics, the First Hospital of Jilin University, Changchun, 130021, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Shan', 'Affiliation': 'Department of Developmental and Behavioral Pediatrics, the First Hospital of Jilin University, Changchun, 130021, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Du', 'Affiliation': 'Department of Developmental and Behavioral Pediatrics, the First Hospital of Jilin University, Changchun, 130021, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Developmental and Behavioral Pediatrics, the First Hospital of Jilin University, Changchun, 130021, China.'}, {'ForeName': 'Fei-Yong', 'Initials': 'FY', 'LastName': 'Jia', 'Affiliation': 'Department of Developmental and Behavioral Pediatrics, the First Hospital of Jilin University, Changchun, 130021, China. erkekangfujia@163.com.'}]",Chinese journal of integrative medicine,['10.1007/s11655-019-3082-y']
3298,32098545,Link between body weight changes and metabolic parameters in drugs naïve subjects with type 2 diabetes treated with canagliflozin monotherapy.,"OBJECTIVES


The aim of this study is to investigate the correlations between the changes of body weight and metabolic parameters during canagliflozin treatment.
METHODS


Drug naïve subjects with T2DM (n = 84) received canagliflozin monotherapy for 3 months. The subjects were divided into three groups with equal numbers of subjects (n = 28 each) according to the reductions of BMI levels; highest (group A), intermediate (group B), and lowest (group C) reductions. Changes of the metabolic parameters were compared between group A and group C. These two groups acted as a control of each other.
RESULTS


Significant reductions of BMI levels (-4.1%, p < 0.00001) were observed in group A, while, surprisingly, significant increases (+1.5%, p < 0.00001) were seen in group C. In these two groups, similar reductions of HbA1c, FBG, or HOMA-R, and increases of HOMA-B levels were observed. Significant reductions of TG levels (-18.6%) were seen only in group A. At baseline, HbA1c levels were significantly lower in group A versus group C (p < 0.03). In group A, significant correlations between the changes of BMI and those of HbA1c (R = 0.496) were seen. By contrast, in group C, significant negative correlations were observed between these parameters (R = -0.463).
CONCLUSIONS


These results suggest that certain populations treated with canagliflozin gained weight, though similar glycemic and beta-cell/insulin sensitivity enhancing properties were observed in comparison to those with efficient weight reductions. Those who lost more weight had better glycemic efficacy in group A. By contrast, those who gained more weight had better glycemic efficacy in group C. Distinct glucose-lowering mechanisms might be operating between these two groups. Involvement of some factors including glucagons and free fatty acids is hypothesized.",2020,"At baseline, HbA1c levels were significantly lower in group A versus group C (p<0.03).","['naïve subjects with T2DM (n=84) received', 'drugs naïve subjects with type 2 diabetes treated with']","['canagliflozin monotherapy', 'canagliflozin treatment']","['TG levels', 'BMI levels', 'glycemic efficacy', 'HbA1c levels', 'HbA1c, FBG or HOMA-R, and increases of HOMA-B levels', 'body weight and metabolic parameters']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0120316,"At baseline, HbA1c levels were significantly lower in group A versus group C (p<0.03).","[{'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Kutoh', 'Affiliation': 'Division of Clinical Research, Biomedical Center , Tokyo, Japan.'}, {'ForeName': 'Asuka', 'Initials': 'A', 'LastName': 'Wada', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Gyoda General Hospital , Saitama, Japan.'}, {'ForeName': 'Alexandra N', 'Initials': 'AN', 'LastName': 'Kuto', 'Affiliation': 'Division of Clinical Research, Biomedical Center , Tokyo, Japan.'}, {'ForeName': 'Jyunka', 'Initials': 'J', 'LastName': 'Hayashi', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Gyoda General Hospital , Saitama, Japan.'}, {'ForeName': 'Rumi', 'Initials': 'R', 'LastName': 'Kurihara', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Gyoda General Hospital , Saitama, Japan.'}]",Hospital practice (1995),['10.1080/21548331.2020.1732098']
3299,32034969,Omega-3 fatty acid supplementation in pregnancy-baseline omega-3 status and early preterm birth: exploratory analysis of a randomised controlled trial.,"OBJECTIVE


To identify a polyunsaturated fatty acid (PUFA) biomarker able to detect which women with singleton pregnancies are most likely to benefit from omega-3 supplementation to reduce their risk of early preterm birth.
DESIGN


Exploratory analysis of a randomised controlled trial.
SETTING


Six Australian hospitals.
POPULATION


Women with a singleton pregnancy enrolled in the ORIP trial.
METHODS


Using maternal capillary whole blood collected ~14 weeks' gestation, the fatty acids in total blood lipids were quantified using gas chromatography. Interaction tests examined whether baseline PUFA status modified the effect of omega-3 supplementation on birth outcomes.
MAIN OUTCOME MEASURE


Early preterm birth (<34 weeks' gestation).
RESULTS


A low total omega-3 PUFA status in early pregnancy was associated with a higher risk of early preterm birth. Among women with a total omega-3 status ≤4.1% of total fatty acids, omega-3 supplementation substantially reduced the risk of early preterm birth compared with control (0.73 versus 3.16%; relative risk = 0.23, 95% confidence interval [CI] 0.07-0.79). Conversely, women with higher total omega-3 status in early pregnancy were at lower risk of early preterm birth. Supplementing women with a baseline status above 4.9% increased early preterm birth (2.20 versus 0.97%; relative risk = 2.27, 95% CI 1.13-4.58).
CONCLUSIONS


Women with singleton pregnancies and low total omega-3 PUFA status early in pregnancy have an increased risk of early preterm birth and are most likely to benefit from omega-3 supplementation to reduce this risk. Women with higher total omega-3 status are at lower risk and additional omega-3 supplementation may increase their risk.
TWEETABLE ABSTRACT


Low total omega-3 fat status helps identify which women benefit from extra omega-3 to reduce early prematurity.",2020,"Supplementing women with a baseline status above 4.9% increased early preterm birth (2.20% vs. 0.97%; relative risk=2.27, 95% CI 1.13-4.58).
","['Pregnancy - Baseline Omega-3 Status and Early Preterm Birth', 'women with singleton pregnancies', 'Six Australian hospitals', 'Women with singleton pregnancies', 'Women with a singleton pregnancy enrolled in the ORIP trial']","['Omega-3 Fatty Acid Supplementation', 'omega-3 supplementation', 'polyunsaturated fatty acid (PUFA) biomarker']","['early preterm birth', 'fatty acids in total blood lipids', 'higher risk of early preterm birth', ""Early preterm birth (<34 weeks' gestation"", 'risk of early preterm birth']","[{'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation (product)'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.2712,"Supplementing women with a baseline status above 4.9% increased early preterm birth (2.20% vs. 0.97%; relative risk=2.27, 95% CI 1.13-4.58).
","[{'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Simmonds', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute, Adelaide, SA, Australia.'}, {'ForeName': 'T R', 'Initials': 'TR', 'LastName': 'Sullivan', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute, Adelaide, SA, Australia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Skubisz', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute, Adelaide, SA, Australia.'}, {'ForeName': 'P F', 'Initials': 'PF', 'LastName': 'Middleton', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute, Adelaide, SA, Australia.'}, {'ForeName': 'K P', 'Initials': 'KP', 'LastName': 'Best', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute, Adelaide, SA, Australia.'}, {'ForeName': 'L N', 'Initials': 'LN', 'LastName': 'Yelland', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute, Adelaide, SA, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Quinlivan', 'Affiliation': 'The Institute of Health Research, University of Notre Dame, Fremantle, WA, Australia.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Zhou', 'Affiliation': 'The School of Agriculture, Food and Wine, The University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute, Adelaide, SA, Australia.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'McPhee', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute, Adelaide, SA, Australia.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Gibson', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute, Adelaide, SA, Australia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Makrides', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute, Adelaide, SA, Australia.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16168']
3300,32125555,Effect of Saccharomyces boulardii CNCM I-745 as complementary treatment of Helicobacter pylori infection on gut microbiome.,"Conventional therapy for H. pylori infection includes the combination of antibiotics and a proton-pump inhibitor. Addition of probiotics as adjuvants for H. pylori antibiotic treatment can increase eradication rate and decrease treatment side effects. Although many studies show the benefits of S. boulardii CNCM I-745 in the treatment of H. pylori infection, the mechanism by which those benefits are achieved is unknown. Here, we report clinical characteristics and fecal microbiota changes comparing conventional anti-H. pylori therapy versus conventional therapy supplemented with S. boulardii CNCM I-745. A total of 74 patients were included in the current study; patients positive for H. pylori (n = 63) were randomly assigned to 2 groups: 34 patients received conventional therapy and 29 antibiotic therapy plus 750 mg of S. boulardii CNCM I-745 daily, for 2 weeks. Eleven patients negative for H. pylori infection were also studied. Patients provided 3 fecal samples: before initiating the antibiotic treatment, upon its completion, and 1 month after treatment. Patients were contacted every 72 h to inquire about side effects and compliance. DNA was extracted, and 16S rRNA was amplified and sequenced on Illumina MiSeq. Bioinformatic analysis was performed using QIIME2. Patients who received the probiotic had a significantly lower frequency of associated gastrointestinal symptoms (P = 0.028); higher number of bacterial diversity evenness (P = 0.0156); higher abundance of Enterobacteria; and lower abundance of Bacteroides and Clostridia upon treatment completion. Addition of S. boulardii CNCM I-745 induced a lower frequency of gastrointestinal symptoms that could be related to changes in gut microbiota.",2020,Patients who received the probiotic had a significantly lower frequency of associated gastrointestinal symptoms (P = 0.028); higher number of bacterial diversity evenness (P = 0.0156); higher abundance of Enterobacteria; and lower abundance of Bacteroides and Clostridia upon treatment completion.,"['74 patients were included in the current study; patients positive for H. pylori (n\u2009=\u200963', 'Helicobacter pylori infection on gut microbiome', 'Eleven patients']","['conventional therapy and 29 antibiotic therapy plus 750\xa0mg of S. boulardii CNCM', 'conventional anti-H. pylori therapy versus conventional therapy supplemented with S. boulardii CNCM I-745', 'Saccharomyces boulardii CNCM I-745', 'boulardii CNCM', 'Conventional therapy']","['abundance of Enterobacteria', 'gastrointestinal symptoms', 'eradication rate', 'frequency of associated gastrointestinal symptoms', 'bacterial diversity evenness', 'negative for H. pylori infection']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0338237', 'cui_str': 'Antibiotic therapy (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0772093', 'cui_str': 'Saccharomyces boulardii'}]","[{'cui': 'C0014346', 'cui_str': 'Coliform Bacilli'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",74.0,0.0552547,Patients who received the probiotic had a significantly lower frequency of associated gastrointestinal symptoms (P = 0.028); higher number of bacterial diversity evenness (P = 0.0156); higher abundance of Enterobacteria; and lower abundance of Bacteroides and Clostridia upon treatment completion.,"[{'ForeName': 'Paúl A', 'Initials': 'PA', 'LastName': 'Cárdenas', 'Affiliation': 'Instituto de Microbiología, COCIBA, Universidad San Francisco de Quito, Quito, Ecuador. pacardenas@usfq.edu.ec.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Garcés', 'Affiliation': 'Instituto de Microbiología, COCIBA, Universidad San Francisco de Quito, Quito, Ecuador.'}, {'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Prado-Vivar', 'Affiliation': 'Centro de Bioinformática, Universidad San Francisco de Quito, Quito, Ecuador.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Flores', 'Affiliation': 'Centro de Investigación Biomédica, Facultad de Ciencias de la Salud Eugenio Espejo, Universidad UTE, Quito, Ecuador.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Fornasini', 'Affiliation': 'Centro de Investigación Biomédica, Facultad de Ciencias de la Salud Eugenio Espejo, Universidad UTE, Quito, Ecuador.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Cohen', 'Affiliation': 'Facultad de Medicina, Universidad de la República, Montevideo, Uruguay.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Salvador', 'Affiliation': 'Centro de Investigación Biomédica, Facultad de Ciencias de la Salud Eugenio Espejo, Universidad UTE, Quito, Ecuador.'}, {'ForeName': 'Oswaldo', 'Initials': 'O', 'LastName': 'Cargua', 'Affiliation': 'Centro de Investigación Biomédica, Facultad de Ciencias de la Salud Eugenio Espejo, Universidad UTE, Quito, Ecuador.'}, {'ForeName': 'Manuel E', 'Initials': 'ME', 'LastName': 'Baldeón', 'Affiliation': 'Centro de Investigación Biomédica, Facultad de Ciencias de la Salud Eugenio Espejo, Universidad UTE, Quito, Ecuador.'}]",European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology,['10.1007/s10096-020-03854-3']
3301,32128634,Health-related quality of life associated with trifluridine/tipiracil in heavily pretreated metastatic gastric cancer: results from TAGS.,"BACKGROUND


In TAGS, an international, double-blind, phase 3 trial, trifluridine/tipiracil significantly improved overall survival and progression-free survival compared with placebo in heavily pretreated metastatic gastric cancer patients. This paper reports pre-specified quality of life (QoL) outcomes for TAGS.
METHODS


Patients were randomized 2:1 to trifluridine/tipiracil (35 mg/m 2  twice daily on days 1-5 and 8-12 of each 28-day cycle) plus best supportive care (BSC) or placebo plus BSC. QoL was evaluated at baseline and at each treatment cycle, using the EORTC QLQ-C30 and EORTC QLQ-STO22 questionnaires; results were considered valid for analysis only if ≥ 10% of patients completed the questionnaires. Key QoL outcomes were mean changes from baseline and time to deterioration in QoL. A post hoc analysis assessed the association between QoL and time to deterioration of Eastern Cooperative Oncology Group performance score (ECOG PS) to ≥ 2.
RESULTS


Of 507 randomized patients, 496 had baseline QoL data available. The analysis cut-off was 6 cycles for trifluridine/tipiracil and 3 cycles for placebo. In both treatment groups, there were no clinically significant deteriorations in the mean QLQ-C30 Global Health Status (GHS) score, or in most subscale scores. In a sensitivity analysis including death and disease progression as events, there was a trend towards trifluridine/tipiracil reducing the risk of deterioration of QoL scores compared with placebo. Deterioration in the GHS score was associated with deterioration in ECOG PS.
CONCLUSION


QoL was maintained in TAGS, and there was a trend towards trifluridine/tipiracil reducing the risk of QoL deterioration compared with placebo. Trial registration ClinicalTrials.gov number: NCT02500043.",2020,"In both treatment groups, there were no clinically significant deteriorations in the mean QLQ-C30 Global Health Status (GHS) score, or in most subscale scores.","['heavily pretreated metastatic gastric cancer patients', 'Patients', 'Of 507 randomized patients, 496 had baseline QoL data available', 'heavily pretreated metastatic gastric cancer']","['placebo', 'trifluridine/tipiracil (35\xa0mg/m 2  twice daily on days 1-5 and 8-12 of each 28-day cycle) plus best supportive care (BSC) or placebo plus BSC', 'trifluridine/tipiracil']","['death and disease progression', 'QoL', 'risk of deterioration of QoL scores', 'overall survival and progression-free survival', 'mean QLQ-C30 Global Health Status (GHS) score, or in most subscale scores', 'pre-specified quality of life (QoL) outcomes']","[{'cui': 'C0278498', 'cui_str': 'Metastatic gastric cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450381', 'cui_str': '507'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0040987', 'cui_str': 'Trifluridine'}, {'cui': 'C4056441', 'cui_str': 'tipiracil'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}]",507.0,0.549219,"In both treatment groups, there were no clinically significant deteriorations in the mean QLQ-C30 Global Health Status (GHS) score, or in most subscale scores.","[{'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Tabernero', 'Affiliation': ""Vall d'Hebron University Hospital and Institute of Oncology (VHIO), UVic-UCC, IOB-Quiron, Barcelona, Spain. jtabernero@vhio.net.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Alsina', 'Affiliation': ""Vall d'Hebron University Hospital and Institute of Oncology (VHIO), UVic-UCC, IOB-Quiron, Barcelona, Spain.""}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Shitara', 'Affiliation': 'National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Doi', 'Affiliation': 'National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Dvorkin', 'Affiliation': 'Omsk Regional Clinical Centre of Oncology, Omsk, Russia.'}, {'ForeName': 'Wasat', 'Initials': 'W', 'LastName': 'Mansoor', 'Affiliation': 'The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Hendrik-Tobias', 'Initials': 'HT', 'LastName': 'Arkenau', 'Affiliation': 'Sarah Cannon Research Institute, London, UK.'}, {'ForeName': 'Aliaksandr', 'Initials': 'A', 'LastName': 'Prokharau', 'Affiliation': 'Minsk City Clinical Oncology Dispensary, Minsk, Belarus.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Ghidini', 'Affiliation': 'Azienda Ospedaliera di Cremona, Cremona, Italy.'}, {'ForeName': 'Catia', 'Initials': 'C', 'LastName': 'Faustino', 'Affiliation': 'Instituto Português de Oncologia do Porto Francisco Gentil, Porto, Portugal.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Gorbunova', 'Affiliation': 'N.N. Blokhin Russian Cancer Research Center, Moscow, Russia.'}, {'ForeName': 'Edvard', 'Initials': 'E', 'LastName': 'Zhavrid', 'Affiliation': 'Alexandrov National Cancer Centre of Belarus, Minsk, Belarus.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Nishikawa', 'Affiliation': 'Osaka National Hospital, Osaka, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Ando', 'Affiliation': 'University of Toyama, Toyama, Japan.'}, {'ForeName': 'Şuayib', 'Initials': 'Ş', 'LastName': 'Yalçın', 'Affiliation': 'Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'University Hospitals and KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Sabater', 'Affiliation': 'Market Access Department, Servier, Suresnes, France.'}, {'ForeName': 'Donia', 'Initials': 'D', 'LastName': 'Skanji', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Leger', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Amellal', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Ilson', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}]",Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association,['10.1007/s10120-020-01053-9']
3302,32125668,Effects of Autograft Types on Muscle Strength and Functional Capacity in Patients Having Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial.,"BACKGROUND


The effects of different autograft types for anterior cruciate ligament reconstruction (ACL-R) on muscle function are sparsely investigated in randomized controlled trials. Our aim was to investigate the effects of quadriceps tendon autograft (QTB) vs. semitendinosus-gracilis autograft (StG) on thigh muscle strength and functional capacity, and a patient-reported outcome 1 year after ACL-R, and to compare the results to healthy controls.
METHODS


ACL-R patients (n = 100) and matched controls (CON, n = 50) were recruited, with patients being randomly assigned to QTB (n = 50) or StG (n = 50) ACL-R. One year after ACL-R, bilateral knee extensor (KE) and flexor (KF) muscle strength (isometric, dynamic, explosive, limb symmetry index [LSI], hamstring:quadriceps ratio [HQ ratio]) were assessed by isokinetic dynamometry, along with functional capacity (single leg hop distance [SHD]) and a patient-reported outcome (International Knee Documentation Committee [IKDC] score).
RESULTS


KE muscle strength of the operated leg was lower (9-11%) in QTB vs. StG as was KE LSI, while KF muscle strength was lower (12-17%) in StG vs. QTB as was KF LSI. HQ ratios were lower in StG vs. QTB. Compared with the controls, KE and KF muscle strength were lower in StG (10-22%), while KE muscle strength only was lower in QTB (16-25%). Muscle strength in the StG, QTB, and CON groups was identical in the non-operated leg. While SHD and IKDC did not differ between StG and QTB, SHD in both StG and QTB was lower than CON. The IKDC scores improved significantly 1 year following ACL-R for both graft types.
CONCLUSION


One year after ACL-R, muscle strength is affected by autograft type, with StG leading to impairments of KE and KF muscle strength, while QTB results in more pronounced impairments of KE only. Functional capacity and patient-reported outcome were unaffected by autograft type, with the former showing impairment compared to healthy controls.
CLINICAL TRIALS REGISTRATION NUMBER


NCT02173483.",2020,"RESULTS


KE muscle strength of the operated leg was lower (9-11%) in QTB vs. StG as was KE LSI, while KF muscle strength was lower (12-17%) in StG vs. QTB as was KF LSI.","['Patients', 'Having Anterior Cruciate Ligament Reconstruction', 'ACL-R patients (n\u2009=\u2009100) and matched controls (CON, n\u2009=\u200950']","['quadriceps tendon autograft (QTB) vs. semitendinosus-gracilis autograft (StG', 'Autograft Types', 'QTB', 'StG (n\u2009=\u200950) ACL-R. One year after ACL-R, bilateral knee extensor (KE) and flexor (KF) muscle strength (isometric, dynamic, explosive, limb symmetry index [LSI], hamstring:quadriceps ratio [HQ ratio]) were assessed by isokinetic dynamometry, along with functional capacity (single leg hop distance [SHD', 'anterior cruciate ligament reconstruction (ACL-R']","['patient-reported outcome (International Knee Documentation Committee [IKDC] score', 'KE muscle strength of the operated leg', 'IKDC scores', 'KE and KF muscle strength', 'thigh muscle strength and functional capacity', 'Muscle Strength and Functional Capacity', 'KE muscle strength', 'Muscle strength', 'KF muscle strength', 'HQ ratios']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}, {'cui': 'C0224453', 'cui_str': 'Semitendinosus'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C1721090', 'cui_str': 'Explosives'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0332516', 'cui_str': 'Symmetry'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C4018995', 'cui_str': 'Hop'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}]","[{'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0039866', 'cui_str': 'Thigh'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0471684,"RESULTS


KE muscle strength of the operated leg was lower (9-11%) in QTB vs. StG as was KE LSI, while KF muscle strength was lower (12-17%) in StG vs. QTB as was KF LSI.","[{'ForeName': 'Kasper Staghøj', 'Initials': 'KS', 'LastName': 'Sinding', 'Affiliation': 'Department of Sports Traumatology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Torsten Grønbech', 'Initials': 'TG', 'LastName': 'Nielsen', 'Affiliation': 'Department of Sports Traumatology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Lars Grøndahl', 'Initials': 'LG', 'LastName': 'Hvid', 'Affiliation': 'Exercise Biology, Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lind', 'Affiliation': 'Department of Orthopedic Surgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Dalgas', 'Affiliation': 'Exercise Biology, Department of Public Health, Aarhus University, Aarhus, Denmark. dalgas@ph.au.dk.'}]","Sports medicine (Auckland, N.Z.)",['10.1007/s40279-020-01276-x']
3303,32097058,Auditory Perception and Ultrasound Biofeedback Treatment Outcomes for Children With Residual /ɹ/ Distortions: A Randomized Controlled Trial.,"Purpose This study evaluated whether outcomes from treatment, which includes ultrasound visual feedback (UVF), would be more or less effective when combined with auditory perception training for children with residual /ɹ/ errors. Method Children ages 8-16 years with /ɹ/ distortions participated in speech therapy that included real-time UVF of the tongue. Thirty-eight participants were randomized to speech therapy conditions that included a primary focus on articulation using UVF or a condition that included auditory perceptual training plus UVF (incorporating category goodness judgments and self-monitoring). Generalization of /ɹ/ production accuracy to untrained words was assessed before and after 14 hr of therapy. Additionally, the role of auditory perceptual acuity was explored using a synthetic /ɹ/-/w/ continuum. Results There was no difference between the treatment groups in rate of improvement of /ɹ/ accuracy (increase of 34% for each group;  p =  .95, η p 2  = .00). However, pretreatment auditory acuity was associated with treatment progress in both groups, with finer perceptual acuity corresponding to greater progress ( p  = .015, η p 2  = .182). Conclusion Similar gains in speech sound accuracy can be made with treatment that includes UVF with or without auditory perceptual training. Fine-grained perceptual acuity may be a prognostic indicator with treatment. Supplemental Material https://doi.org/10.23641/asha.11886219.",2020,"There was no difference between the treatment groups in rate of improvement of /ɹ/ accuracy (increase of 34% for each group;  p =  .95, η p 2  = .00).","['Thirty-eight participants', 'Method Children ages 8-16 years with /ɹ/ distortions participated in speech therapy that included real-time UVF of the tongue', 'Children With Residual /ɹ/ Distortions', 'children with residual /ɹ/ errors']","['Supplemental Material https://doi.org/10.23641/asha.11886219', 'ultrasound visual feedback (UVF', 'Auditory Perception and Ultrasound Biofeedback', 'auditory perception training', 'speech therapy conditions that included a primary focus on articulation using UVF or a condition that included auditory perceptual training plus UVF (incorporating category goodness judgments and self-monitoring']","['auditory perceptual acuity', 'rate of improvement of /ɹ/ accuracy', 'pretreatment auditory acuity']","[{'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332482', 'cui_str': 'Abnormal shape'}, {'cui': 'C0037831', 'cui_str': 'Speech Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0040408', 'cui_str': 'Tongue'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}]","[{'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0037831', 'cui_str': 'Speech Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0556503', 'cui_str': 'Perceptual training (regime/therapy)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0022423', 'cui_str': 'Judgment'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0679027', 'cui_str': 'Auditory acuity'}]",38.0,0.0281561,"There was no difference between the treatment groups in rate of improvement of /ɹ/ accuracy (increase of 34% for each group;  p =  .95, η p 2  = .00).","[{'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Preston', 'Affiliation': 'Department of Communication Sciences and Disorders, Syracuse University, NY.'}, {'ForeName': 'Elaine R', 'Initials': 'ER', 'LastName': 'Hitchcock', 'Affiliation': 'Department of Communication Sciences and Disorders, Montclair State University, NJ.'}, {'ForeName': 'Megan C', 'Initials': 'MC', 'LastName': 'Leece', 'Affiliation': 'Department of Communication Sciences and Disorders, Syracuse University, NY.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2019_JSLHR-19-00060']
3304,32011502,Comparison of the immediate analgesic effect of perpendicular needling and transverse needling at SP6 in patients with primary dysmenorrhea: Study protocol for a randomized controlled trial.,"BACKGROUND


Acupuncture has been widely used to treat primary dysmenorrhea (PD) with satisfactory outcomes. Sanyinjiao (SP6) is the most commonly used acupoint for PD. Different needling techniques may influence the effect of SP6, and its underlying mechanism needs to be explored. This randomized controlled parallel trial is designed to evaluate the immediate analgesic effect and hemodynamic responses in uterine arterial blood flow of perpendicular needling and transverse needling at SP6 in patients with PD of cold-dampness stagnation pattern using color doppler ultrasonography.
METHODS


Forty-eight patients who meet inclusion criteria will be randomized in a ratio of 1:1 to either perpendicular needling or transverse needling groups. Every participant will receive 1 session of acupuncture treatment for 10 minutes at bilateral SP6. In the perpendicular needling group, needles will be inserted vertically 1 to 1.2 cun and will be manipulated to achieve needling sensation. In transverse needling group, the needles will be inserted transversely 1 to 1.2 cun toward the abdomen without any manipulation to avoid needling sensation. Color doppler ultrasonography will be performed before, during, and after needling. The primary outcome measure is visual analog scale for pain. The secondary outcome measures include the uterine artery blood flow changes by measuring pulsatility index, resistance index values, and ratio of systolic peak and diastolic peak, the Hamilton anxiety scale, blood pressure, and heart rate. Adverse events in both groups also will be recorded.
DISCUSSION


This trial will be the first study protocol designed to explore the influence of needling techniques on the analgesia effect of solo acupoint and its hemodynamic responses for PD. It will promote more widespread awareness of the benefits of using suitable needling techniques in acupuncture clinical setting and provide a further explanation of the underlying hemodynamic mechanism.
TRIAL REGISTRATION


This study protocol was registered at the Chinese clinical trial registry (ChiCTR1900026051).",2020,"This randomized controlled parallel trial is designed to evaluate the immediate analgesic effect and hemodynamic responses in uterine arterial blood flow of perpendicular needling and transverse needling at SP6 in patients with PD of cold-dampness stagnation pattern using color doppler ultrasonography.
","['Forty-eight patients who meet inclusion criteria', 'patients with primary dysmenorrhea', 'patients with PD of cold-dampness stagnation pattern using color doppler ultrasonography']","['needles will be inserted transversely 1 to 1.2 cun toward the abdomen without any manipulation to avoid needling sensation', 'acupuncture', 'perpendicular needling and transverse needling at SP6', 'Acupuncture', 'solo acupoint', 'perpendicular needling or transverse needling groups']","['visual analog scale for pain', 'uterine artery blood flow changes by measuring pulsatility index, resistance index values, and ratio of systolic peak and diastolic peak, the Hamilton anxiety scale, blood pressure, and heart rate', 'Adverse events']","[{'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea (disorder)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0242844', 'cui_str': 'Ultrasonography, Doppler, Color'}]","[{'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0446380', 'cui_str': 'Transverse (qualifier value)'}, {'cui': 'C0450548', 'cui_str': 'SP6 (body structure)'}, {'cui': 'C0001302', 'cui_str': 'Acupoints'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0226378', 'cui_str': 'Uterine Artery'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0222045'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",48.0,0.145476,"This randomized controlled parallel trial is designed to evaluate the immediate analgesic effect and hemodynamic responses in uterine arterial blood flow of perpendicular needling and transverse needling at SP6 in patients with PD of cold-dampness stagnation pattern using color doppler ultrasonography.
","[{'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Afshari Fard', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Mohammadi', 'Affiliation': ''}, {'ForeName': 'Liang-Xiao', 'Initials': 'LX', 'LastName': 'Ma', 'Affiliation': ''}, {'ForeName': 'Jie-Dan', 'Initials': 'JD', 'LastName': 'Mu', 'Affiliation': ''}, {'ForeName': 'Wen-Yan', 'Initials': 'WY', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Jun-Xiang', 'Initials': 'JX', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Ying-Ying', 'Initials': 'YY', 'LastName': 'Gan', 'Affiliation': ''}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': ''}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Qian', 'Affiliation': ''}, {'ForeName': 'Tian-Yi', 'Initials': 'TY', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Iravani', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000018847']
3305,31394130,"Efficacy and safety of methotrexate versus placebo as add-on therapy to H1 antihistamines for patients with difficult-to-treat chronic spontaneous urticaria: A randomized, controlled trial.",,2020,,['patients with chronic spontaneous urticaria resistant to H1-antihistamines'],"['methotrexate', 'placebo']",['Efficacy and safety'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0578870', 'cui_str': 'Chronic idiopathic urticaria (disorder)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0019590', 'cui_str': 'Antihistamines'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.236275,,"[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Leducq', 'Affiliation': 'Department of Dermatology, University Hospital of Tours, Tours, France; Clinical Investigation Center, INSERM CIC 1415, University Hospital of Tours, Tours, France; Université de Tours, Université de Nantes, INSERM U1246-SPHERE, France. Electronic address: soleducq@gmail.com.'}, {'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Samimi', 'Affiliation': 'Department of Dermatology, University Hospital of Tours, Tours, France; ISP 1282 INRA, University of Tours, Tours, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Bernier', 'Affiliation': 'Department of Dermatology, University Hospital Center of Nantes, Nantes, France.'}, {'ForeName': 'Angèle', 'Initials': 'A', 'LastName': 'Soria', 'Affiliation': 'Department of Dermatology and Allergology, Hospital Tenon, Paris, Assistance Publique Hopitaux de Paris, Sorbonne Université, Paris, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Amsler', 'Affiliation': 'Department of Dermatology and Allergology, Hospital Tenon, Paris, Assistance Publique Hopitaux de Paris, Sorbonne Université, Paris, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Staumont-Sallé', 'Affiliation': 'CHU Lille, Service de dermatologie et vénérologie, F-59000 Lille, France, Univ. Lille, Inserm U995 - LIRIC - Lille Inflammation Research International Center, F-59000 Lille, France.'}, {'ForeName': 'Germaine', 'Initials': 'G', 'LastName': 'Gabison', 'Affiliation': 'Department of Dermatology, Assistance Publique Hôpitaux de Paris, Henri-Mondor Hospital, Créteil, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Chosidow', 'Affiliation': 'Department of Dermatology, Assistance Publique Hôpitaux de Paris, Henri-Mondor Hospital, Créteil, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Bénéton', 'Affiliation': 'Department of Dermatology, Hospital Center of le Mans, le Mans, France.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Bara', 'Affiliation': 'Department of Dermatology, Hospital Center of le Mans, le Mans, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Grange-Prunier', 'Affiliation': 'Department of Dermatology, Reims University Hospital, University of Reims-Champagne-Ardenne, Reims, France.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Wierzbicka-Hainaut', 'Affiliation': 'Department of Dermatology, University Hospital of Poitiers, Poitiers, France.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Brenaut', 'Affiliation': 'Department of Dermatology, University Hospital of Brest, Brest, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Droitcourt', 'Affiliation': 'Department of Dermatology, University Hospital of Rennes, Rennes, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Raison-Peyron', 'Affiliation': 'Department of Dermatology, University Hospital of Montpellier, Montpellier, France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Bourgoin', 'Affiliation': 'Department of Pharmacy, University Hospital of Tours, Tours, France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Cornillier', 'Affiliation': 'Department of Dermatology, University Hospital of Tours, Tours, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Machet', 'Affiliation': 'Department of Dermatology, University Hospital of Tours, Tours, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Giraudeau', 'Affiliation': 'Clinical Investigation Center, INSERM CIC 1415, University Hospital of Tours, Tours, France; Université de Tours, Université de Nantes, INSERM U1246-SPHERE, France.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Caille', 'Affiliation': 'Clinical Investigation Center, INSERM CIC 1415, University Hospital of Tours, Tours, France; Université de Tours, Université de Nantes, INSERM U1246-SPHERE, France.'}, {'ForeName': 'Annabel', 'Initials': 'A', 'LastName': 'Maruani', 'Affiliation': 'Department of Dermatology, University Hospital of Tours, Tours, France; Université de Tours, Université de Nantes, INSERM U1246-SPHERE, France.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.07.097']
3306,31313237,Impact of Exercise on Body Composition and Cardiometabolic Risk Factors in Patients Awaiting Bariatric Surgery.,"BACKGROUND


The role of exercise to achieve weight reductions in patients awaiting bariatric surgery has been little studied. The aim of this study was to describe the effects of an exercise program on body composition and cardiometabolic risk factors in patients awaiting bariatric surgery.
METHODS


Twenty-three patients awaiting bariatric surgery were divided into two groups: (a) an exercise group (EG, n = 12) and (b) a control group (CG, n = 11). Both groups received the usual care prior to surgery, but the EG also performed a 12-week exercise program which combined endurance and resistance training. Body composition, cardiometabolic risk factors, physical fitness, basal metabolic rate, and quality of life were assessed at baseline and at the end of the study.
RESULTS


After the exercise program, the EG achieved significant reductions in total weight (- 7.3 ± 4.1 kg, P < 0.01), fat mass (- 7.1 ± 4.7 kg, P < 0.01), and waist circumference (- 5.3 ± 2.1 cm, P < 0.01), while they maintained their fat-free mass and basal metabolic rate levels. Only the EG showed reductions in HbA1c (- 0.4 ± 0.45%, P < 0.05), systolic (- 10.5 ± 12.7 mmHg), and diastolic blood pressure (- 3.9 ± 5.2 mmHg, P < 0.05), as well as a decrease in waist-to-height ratio (- 0.032 ± 0.12, P < 0.01) and an improvement in quality of life.
CONCLUSIONS


The implementation of an exercise program prior to bariatric surgery reduces fat mass and central obesity and improves cardiometabolic risk factors and quality of life, especially in the physical scales.
TRIAL REGISTRATION


The study was registered at ClinicalTrials.gov (NCT03613766).",2019,"Only the EG showed reductions in HbA1c (- 0.4 ± 0.45%, P < 0.05), systolic (- 10.5 ± 12.7 mmHg), and diastolic blood pressure (- 3.9 ± 5.2 mmHg, P < 0.05), as well as a decrease in waist-to-height ratio (- 0.032 ± 0.12, P < 0.01) and an improvement in quality of life.
","['Twenty-three patients awaiting bariatric surgery', 'Patients Awaiting Bariatric Surgery', 'patients awaiting bariatric surgery']","['exercise program', 'Exercise', 'exercise program prior to bariatric surgery', 'usual care prior to surgery, but the EG also performed a 12-week exercise program which combined endurance and resistance training']","['waist-to-height ratio', 'Body composition, cardiometabolic risk factors, physical fitness, basal metabolic rate, and quality of life', 'fat mass and central obesity and improves cardiometabolic risk factors and quality of life', 'diastolic blood pressure', 'total weight', 'Body Composition and Cardiometabolic Risk Factors', 'quality of life', 'weight reductions', 'fat mass', 'systolic', 'waist circumference', 'body composition and cardiometabolic risk factors']","[{'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C1821269', 'cui_str': 'Height-Weight Ratio'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0678121', 'cui_str': 'Basal metabolic rate (observable entity)'}, {'cui': 'C0034380'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C4551560', 'cui_str': 'Central obesity (disorder)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}]",23.0,0.0221704,"Only the EG showed reductions in HbA1c (- 0.4 ± 0.45%, P < 0.05), systolic (- 10.5 ± 12.7 mmHg), and diastolic blood pressure (- 3.9 ± 5.2 mmHg, P < 0.05), as well as a decrease in waist-to-height ratio (- 0.032 ± 0.12, P < 0.01) and an improvement in quality of life.
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Marc-Hernández', 'Affiliation': 'Laboratory of Training Analysis and Optimization, Sport Research Center, Miguel Hernandez University, Elche, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ruiz-Tovar', 'Affiliation': 'Center of Excellence for the Diagnosis and Treatment of Obesity and Diabetes, Valladolid, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Aracil', 'Affiliation': 'Department of Sport Sciences, Sport Research Center, Miguel Hernandez University, Elche, Spain.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Guillén', 'Affiliation': 'Laboratory of Training Analysis and Optimization, Sport Research Center, Miguel Hernandez University, Elche, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Moya-Ramón', 'Affiliation': 'Laboratory of Training Analysis and Optimization, Sport Research Center, Miguel Hernandez University, Elche, Spain. mmoya@umh.es.'}]",Obesity surgery,['10.1007/s11695-019-04088-9']
3307,30784008,Intraoperative reduction of vasopressors using processed electroencephalographic monitoring in patients undergoing elective cardiac surgery: a randomized clinical trial.,"Intraoperative vasopressor and fluid application are common strategies against hypotension. Use of processed electroencephalographic monitoring (pEEG) may reduce vasopressor application, a known risk factor for organ dysfunction, in elective cardiac surgery patients. Randomized single-centre clinical trial at Jena University Hospital. Adult patients operated on cardiopulmonary bypass or off-pump coronary artery bypass grafting were randomised to receive anesthesia with visible or blinded pEEG using Narcotrend™. In blinded-Narcotrend (NT) depth of anesthesia was extrapolated from clinical signs, hemodynamic response and anesthetic concentration, supplemented by target indices between 37 and 64 in the visible-NT group. Intraoperative norepinephrine requirement (primary endpoint), fluid balance, extubation time, delirium occurrence and adverse events were evaluated. Patients of the intent-to-treat population (visible-NT: n = 123, blinded-NT: n = 122) had similar patient and procedural characteristics. Adjusted for type of surgery intraoperative Norepinephrine application was significantly reduced in visible-NT (n = 120, robust mean of cumulative dose 4.71 µg/kg bodyweight) compared to blinded-NT patients (n = 119, 6.14 µg/kg bodyweight) (adjusted robust mean difference 1.71 (95% CI 0.33-3.10) µg/kg bodyweight). Although reduction in patients operated on cardiopulmonary bypass was higher the interaction was not significant in post-hoc subgroup analysis. Intraoperative fluid balance was similar among both groups and strata. Extubation time was non-significantly lower in visible than in blinded-NT group. Overall postoperative delirium risk was 16.4% without differences among the groups. Adverse events-sudden movement/coughing, perspiration or hypertension-occurred more often with visible-NT, while one blinded-NT patient experienced intraoperative awareness. Titration of depth of anesthesia in elective cardiac surgery patients using pEEG allows to reduce application of norepinephrine.",2020,"Adverse events-sudden movement/coughing, perspiration or hypertension-occurred more often with visible-NT, while one blinded-NT patient experienced intraoperative awareness.","['elective cardiac surgery patients using', 'Adult patients operated on cardiopulmonary bypass or off-pump coronary artery bypass grafting', 'Patients of the intent-to-treat population (visible-NT: n\u2009', 'patients undergoing elective cardiac surgery', 'elective cardiac surgery patients']","['pEEG', 'anesthesia with visible or blinded pEEG using Narcotrend™', 'Intraoperative reduction of vasopressors using processed electroencephalographic monitoring', 'processed electroencephalographic monitoring (pEEG', 'Intraoperative vasopressor and fluid application']","['Overall postoperative delirium risk', 'visible-NT', 'surgery intraoperative Norepinephrine application', 'Extubation time', 'Intraoperative norepinephrine requirement (primary endpoint), fluid balance, extubation time, delirium occurrence and adverse events', 'Intraoperative fluid balance', 'Adverse events-sudden movement/coughing, perspiration or hypertension']","[{'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C1449706', 'cui_str': 'Coronary Artery Bypass, Off-Pump'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205379', 'cui_str': 'Visible (qualifier value)'}]","[{'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0205379', 'cui_str': 'Visible (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C1304879', 'cui_str': 'Electroencephalographic monitoring'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1319200', 'cui_str': 'Postoperative confusion'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205379', 'cui_str': 'Visible (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0016284', 'cui_str': 'Fluid Balance'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1276802', 'cui_str': 'Sudden onset'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0038990', 'cui_str': 'Sweating'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]",,0.485993,"Adverse events-sudden movement/coughing, perspiration or hypertension-occurred more often with visible-NT, while one blinded-NT patient experienced intraoperative awareness.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sponholz', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital, Jena, Germany. christoph.sponholz@med.uni-jena.de.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Schuwirth', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Koenig', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hoyer', 'Affiliation': 'Institute of Medical Statistics, Computer Sciences and Data Sciences, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Coldewey', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Schelenz', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Doenst', 'Affiliation': 'Department of Cardiothoracic Surgery, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kortgen', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bauer', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital, Jena, Germany.'}]",Journal of clinical monitoring and computing,['10.1007/s10877-019-00284-1']
3308,31592329,Effect of vitamin D on serum markers of bone turnover in SLE in a randomised controlled trial.,"Objective


Bone health in SLE is adversely affected by vitamin D deficiency, inflammatory cytokines and glucocorticoid use. We hypothesised that vitamin D supplementation would increase markers of bone formation and decrease markers of bone resorption in SLE subjects.
Methods


We studied 43 vitamin D-deficient SLE subjects who participated in a 12-week randomised controlled trial of 2000-4000 IU/day vitamin D supplementation versus placebo. Subjects had inactive SLE (SLE Disease Activity Index ≤4) and were taking <20 mg prednisone daily at baseline. We assayed baseline and week 12 serum 25-hydroxyvitamin D, N-terminal propeptide of type 1 collagen (P1NP) and C-telopeptide (CTX). We tested the effect of vitamin D versus placebo on change (Δ) in P1NP and ΔCTX in an intention-to-treat analysis. Secondary analyses evaluated whether vitamin D affected bone turnover among subjects achieving vitamin D repletion (≥30 ng/mL) or currently taking glucocorticoids.
Results


28 subjects were randomised to vitamin D and 15 to placebo. Mean age was 39 years and 40% were using glucocorticoids at enrolment. Repletion was achieved by 46% in the vitamin D group versus none in the placebo group. Changes in bone turnover markers were not significantly different in the vitamin D group versus placebo group (median ΔP1NP -0.2 vitamin D group vs -1.1 placebo group (p=0.83); median ΔCTX +3.5 vitamin D group vs -37.0 placebo group (p=0.50)). The effect of vitamin D did not differ based on achieving vitamin D repletion or baseline glucocorticoid use.
Conclusion


Vitamin D supplementation did not affect the 12-week change in bone turnover markers among SLE subjects in this trial.",2019,Changes in bone turnover markers were not significantly different in the vitamin D group versus placebo group (median ΔP1NP -0.2 vitamin D group vs -1.1 placebo group (p=0.83); median ΔCTX +3.5 vitamin D group vs -37.0 placebo group (p=0.50)).,"['Mean age was 39 years and 40% were using glucocorticoids at enrolment', 'Subjects had inactive SLE', '43 vitamin D-deficient SLE subjects who participated', '28 subjects']","['vitamin D versus placebo', 'vitamin D supplementation', 'placebo', 'P1NP and ΔCTX', 'Vitamin D supplementation', 'vitamin D', 'vitamin D supplementation versus placebo']","['bone formation', 'Repletion', 'bone resorption', 'serum markers of bone turnover', 'vitamin D affected bone turnover', 'bone turnover markers', 'serum 25-hydroxyvitamin D, N-terminal propeptide of type 1 collagen (P1NP) and C-telopeptide (CTX']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1141000', 'cui_str': 'Sled, device (physical object)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0029433', 'cui_str': 'Ossification'}, {'cui': 'C0005974', 'cui_str': 'Osteoclastic Bone Loss'}, {'cui': 'C0162491', 'cui_str': 'Serum Markers'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]",28.0,0.703605,Changes in bone turnover markers were not significantly different in the vitamin D group versus placebo group (median ΔP1NP -0.2 vitamin D group vs -1.1 placebo group (p=0.83); median ΔCTX +3.5 vitamin D group vs -37.0 placebo group (p=0.50)).,"[{'ForeName': 'Sara K', 'Initials': 'SK', 'LastName': 'Tedeschi', 'Affiliation': ""Division of Rheumatology, Inflammation, and Immunity, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Aranow', 'Affiliation': 'Center for Autoimmune, Musculoskeletal and Hematopoietic Diseases, Feinstein Institute for Medical Research, Manhasset, New York, USA.'}, {'ForeName': 'Diane L', 'Initials': 'DL', 'LastName': 'Kamen', 'Affiliation': 'Division of Rheumatology, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Meryl', 'Initials': 'M', 'LastName': 'LeBoff', 'Affiliation': 'Department of Medicine, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Diamond', 'Affiliation': 'Center for Autoimmune, Musculoskeletal and Hematopoietic Diseases, Feinstein Institute for Medical Research, Manhasset, New York, USA.'}, {'ForeName': 'Karen H', 'Initials': 'KH', 'LastName': 'Costenbader', 'Affiliation': ""Division of Rheumatology, Inflammation, and Immunity, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}]",Lupus science & medicine,['10.1136/lupus-2019-000352']
3309,32011496,"Efficacy of Phellinus linteus (sanghuang) extract for improving immune functions: Study protocol for a randomized, double-blinded, placebo-controlled pilot trial.","BACKGROUND


With the increase in the prevalence of chronic diseases, enhancing immunity has become an important challenge. Health functional foods, such as Phellitus linteus (PL), are known to improve immune function. In previous laboratory studies, it has been reported that PL has anticancer activities. In this study, we will evaluate if PL improves immune functions in adults with reduced immunity and identify its effects on immunity factors.
METHODS


This study will be a single-center, randomized, double-blinded, and placebo-controlled trial. Study participants will be randomly allocated to 3 experimental groups: those taking PL 1000 mg, PL 2000 mg, or placebo. Total duration of the clinical trial will be 8 to 10 weeks. Study participants will have follow-up visits every 4 weeks and the effect and safety will be assessed at the second and third visits. All participants will be asked to maintain a dosage schedule for this protocol. The primary outcome will be natural killer (NK) cell activity and the secondary outcomes will include peripheral white blood cell (WBC) count; levels of tumor necrosis factor (TNF)-α, interferon (IFN)-γ, and interleukin (IL)-1β, IL-2, IL-6, and IL-12 to assess autoimmune reactivity; and levels of immunoglobulin (Ig)G1, IgG2, and Immunoglobulin M (IgM) to assess allergic activity. Repeated measure analysis will be used to measure primary efficacy based on full analysis set.
DISCUSSION


This study has limited inclusion and exclusion criteria and a well-controlled intervention. It will be the first randomized controlled trial to assess the efficacy and safety of PL in adults with reduced immunity. This study will provide insights into the mechanisms underlying the immune-stimulating effects of PL and lay the groundwork for further studies.",2020,"Study participants will be randomly allocated to 3 experimental groups: those taking PL 1000 mg, PL 2000 mg, or placebo.",['adults with reduced immunity'],"['PL 1000\u200amg, PL 2000\u200amg, or placebo', 'placebo', 'PL', 'Phellinus linteus (sanghuang) extract']","['efficacy and safety', 'natural killer (NK) cell activity and the secondary outcomes will include peripheral white blood cell (WBC) count; levels of tumor necrosis factor (TNF)-α, interferon (IFN)-γ, and interleukin (IL)-1β, IL-2, IL-6, and IL-12 to assess autoimmune reactivity; and levels of immunoglobulin (Ig)G1, IgG2, and Immunoglobulin M (IgM) to assess allergic activity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020964', 'cui_str': 'Immunity'}]","[{'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2003783', 'cui_str': 'Phellinus linteus extract'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022688', 'cui_str': 'NK Cells'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0021756', 'cui_str': 'TCGF'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C0020855', 'cui_str': 'IgG1'}, {'cui': 'C0020856', 'cui_str': 'IgG2'}, {'cui': 'C0020861', 'cui_str': 'IgM'}]",,0.658059,"Study participants will be randomly allocated to 3 experimental groups: those taking PL 1000 mg, PL 2000 mg, or placebo.","[{'ForeName': 'Ga Hyeon', 'Initials': 'GH', 'LastName': 'Jung', 'Affiliation': 'Department of Acupuncture & Moxibustion Medicine, College of Korean Medicine, Daejeon University.'}, {'ForeName': 'Jae Hui', 'Initials': 'JH', 'LastName': 'Kang', 'Affiliation': 'Department of Acupuncture & Moxibustion Medicine, College of Korean Medicine, Daejeon University.'}]",Medicine,['10.1097/MD.0000000000018829']
3310,32011497,"Clinical study on concurrent use of electro-acupuncture or Chuna manual therapy with pregabalin for chemotherapy-induced peripheral neuropathy: safety and effectiveness (open-labeled, parallel, randomized controlled trial, assessor-blinded): A study protocol.","INTRODUCTION


Chemotherapy-induced peripheral neuropathy (CIPN) is one of the major side effects of chemotherapy. Its main symptoms are pain, paresthesia, and numbness. However, the mechanisms underlying the development of CIPN remain unclear and standard treatments have not been established. Recently, there has been a growing interest in various approaches to overcome the limitations of the existing treatments. This study aims to evaluate the efficacy and safety of the concurrent use of two complementary and alternative therapies: electroacupuncture (EA) and Chuna manual therapy (CMT), with pregabalin, which is the conventional pharmacotherapy for neuropathic pain.
METHODS/DESIGN


This is an open-label, parallel, assessor-blinded randomized controlled trial, which includes 90 patients with colorectal and breast cancer, who developed CIPN. After a 2-week preparation period, the patients are divided into three groups (pregabalin administration group, pregabalin + EA treatment group, and pregabalin + CMT treatment group), treated for approximately 5 weeks and followed-up 4 weeks after treatment. The primary outcome is assessed using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity subscale score (version 4.0) and the secondary outcome is measured using the Quality of Life Questionnaire-CIPN 20-Item Scale (version 3.0) and the quality of life questionnaire (version 3.0) developed by the European Organisation for Research and Treatment of Cancer. Moreover, exploratory efficacy and safety evaluations will be conducted based on the chemotherapy-completion rate and nerve conduction studies.",2020,"This study aims to evaluate the efficacy and safety of the concurrent use of two complementary and alternative therapies: electroacupuncture (EA) and Chuna manual therapy (CMT), with pregabalin, which is the conventional pharmacotherapy for neuropathic pain.
","['90 patients with colorectal and breast cancer, who developed CIPN']","['two complementary and alternative therapies: electroacupuncture (EA) and Chuna manual therapy (CMT), with pregabalin', 'pregabalin administration group, pregabalin + EA treatment group, and pregabalin + CMT', 'electro-acupuncture or Chuna manual therapy with pregabalin']","['Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity subscale score (version 4.0) and the secondary outcome is measured using the Quality of Life Questionnaire-CIPN 20-Item Scale (version 3.0) and the quality of life questionnaire (version 3.0) developed by the European Organisation for Research and Treatment of Cancer', 'pain, paresthesia, and numbness', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0949216', 'cui_str': 'Alternative Therapies'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0454525', 'cui_str': 'Manual Therapies'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0222045'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C0035168'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0020580', 'cui_str': 'Reduced Sensation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",90.0,0.0731318,"This study aims to evaluate the efficacy and safety of the concurrent use of two complementary and alternative therapies: electroacupuncture (EA) and Chuna manual therapy (CMT), with pregabalin, which is the conventional pharmacotherapy for neuropathic pain.
","[{'ForeName': 'Jin-Hyun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': ""Institute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital.""}, {'ForeName': 'Tae Jin', 'Initials': 'TJ', 'LastName': 'Cho', 'Affiliation': 'Department of Emergency Medicine.'}, {'ForeName': 'Min Geun', 'Initials': 'MG', 'LastName': 'Park', 'Affiliation': ""Department of Surgery, Catholic Kwandong University International St. Mary's Hospital, Catholic Kwandong University College of Medicine.""}, {'ForeName': 'Ji-Hoon', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': ""Department of Surgery, Catholic University of Korea, Incheon St. Mary's Hospital.""}, {'ForeName': 'Sung Kyu', 'Initials': 'SK', 'LastName': 'Song', 'Affiliation': ""Department of Surgery, Catholic Kwandong University International St. Mary's Hospital, Catholic Kwandong University College of Medicine.""}, {'ForeName': 'Shin-Young', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': ""Department of Surgery, Catholic Kwandong University International St. Mary's Hospital, Catholic Kwandong University College of Medicine.""}, {'ForeName': 'Yun-Young', 'Initials': 'YY', 'LastName': 'Sunwoo', 'Affiliation': 'Iksoodang Korean Medical Clinic, Incheon, South Korea.'}, {'ForeName': 'Ilkyun', 'Initials': 'I', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medicine.'}, {'ForeName': 'Tae-Yong', 'Initials': 'TY', 'LastName': 'Park', 'Affiliation': ""Institute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital.""}]",Medicine,['10.1097/MD.0000000000018830']
3311,31397866,Operative vs Nonoperative Treatment for Atraumatic Rotator Cuff Tears: A Trial Protocol for the Arthroscopic Rotator Cuff Pragmatic Randomized Clinical Trial.,"Importance


Rotator cuff disorders remain the most common cause of shoulder pain and are among the most common reasons for patients to seek care in primary and specialty settings. Although operative and nonoperative treatments are offered to patients with atraumatic rotator cuff tears, there is a lack of evidence to support operative vs nonoperative treatment. This paucity of evidence has been highlighted by several professional agencies and experts.
Objective


To perform a pragmatic randomized clinical trial, the Arthroscopic Rotator Cuff trial, comparing pain and functional outcomes in patients undergoing operative vs nonoperative treatment for atraumatic rotator cuff tears, and assessing heterogeneity of treatment effects by age and tear size.
Design, Setting, and Participants


Trial protocol of the Arthroscopic Rotator Cuff trial. This pragmatic randomized clinical trial of an estimated 700 patients is adequately powered to accomplish its aims with 488 patients. Primary analysis will be conducted on an intent-to-treat population in the context of a mixed model. The multicenter trial started recruitment in 2018 with a 1-year follow-up duration. Patients aged 50 years or older to younger than 85 years with magnetic resonance imaging-confirmed atraumatic rotator cuff tears that are suitable for either operative or nonoperative treatment will be enrolled. Block randomization will be performed and stratified by site, age, and tear size.
Intervention


Nonoperative treatment consists of an approximately 3-month standardized physical therapy program, whereas operative treatment consists of rotator cuff surgery followed by approximately 4 months of postoperative rehabilitation.
Main Outcomes and Measures


The primary outcome is patient-reported Shoulder Pain and Disability Index score, and the secondary outcome is American Shoulder and Elbow Surgeons Standardized Shoulder Form score measured at 1 year of follow-up.
Discussion


The Arthroscopic Rotator Cuff trial is ongoing, and 12 sites with more than 40 physicians are currently recruiting patients. Although there is variation by site, as of May 2, 2019, 13% of all patients screened (787 of 6293) were eligible for the trial, and 9% of eligible patients (74 of 787) were recruited. Results of this study may help patients, clinicians, and policy makers assess the comparative effectiveness of operative vs nonoperative treatment for atraumatic rotator cuff tears.
Trial Registration


ClinicalTrials.gov identifier: NCT03295994.",2019,"Results of this study may help patients, clinicians, and policy makers assess the comparative effectiveness of operative vs nonoperative treatment for atraumatic rotator cuff tears.
","['patients with atraumatic rotator cuff tears', 'Atraumatic Rotator Cuff Tears', '700 patients', 'atraumatic rotator cuff tears', 'patients undergoing operative vs nonoperative treatment for atraumatic rotator cuff tears', '2019, 13% of all patients screened (787 of 6293) were eligible for the trial, and 9% of eligible patients (74 of 787) were recruited', '488 patients', '2018 with a 1-year follow-up duration', 'Patients aged 50 years or older to younger than 85 years with']","['Arthroscopic Rotator Cuff trial', 'magnetic resonance imaging-confirmed atraumatic rotator cuff tears']","['patient-reported Shoulder Pain and Disability Index score, and the secondary outcome is American Shoulder and Elbow Surgeons Standardized Shoulder Form score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0263912', 'cui_str': 'Rotator Cuff Tears'}, {'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0085515', 'cui_str': 'Rotator Cuff'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0263912', 'cui_str': 'Rotator Cuff Tears'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0376315', 'cui_str': 'Form'}]",700.0,0.226756,"Results of this study may help patients, clinicians, and policy makers assess the comparative effectiveness of operative vs nonoperative treatment for atraumatic rotator cuff tears.
","[{'ForeName': 'Nitin B', 'Initials': 'NB', 'LastName': 'Jain', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Ayers', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, Tennessee.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Koudelková', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Kristin R', 'Initials': 'KR', 'LastName': 'Archer', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Dickinson', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Richardson', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Derryberry', 'Affiliation': 'Stakeholder advisory board, Boston, Massachusetts.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Kuhn', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA network open,['10.1001/jamanetworkopen.2019.9050']
3312,30396227,Does the RAM Cannula Provide Continuous Positive Airway Pressure as Effectively as the Hudson Prongs in Preterm Neonates?,"OBJECTIVE


To compare the level of continuous positive airway pressure (CPAP) delivered by the RAM cannula system (Neotech, Valencia, CA) with that delivered by a traditional CPAP nasal delivery interface (Hudson prongs; Hudson-RCI, Temecula, CA) in preterm infants with respiratory distress.
METHODS


This was a crossover intervention study in a convenience sample of preterm infants with respiratory distress requiring treatment with CPAP. We measured the mean intraoral (pharyngeal) pressure, which approximates the applied CPAP level, using both the RAM cannula and Hudson prongs. The primary outcome was a comparison of the differences between the set CPAP levels and the measured intraoral pressures of both delivery systems.
RESULTS


We analyzed data from 12 preterm infants with mean (standard deviation) birth weight of 1,225 (405) g and gestational age of 28.4 (2.1) weeks at a median postnatal age of 10 days. The mean difference (95% confidence interval) between the set CPAP level and measured intraoral pressure was -2.45 cm H 2 O (-3.36, -1.55) with the RAM cannula and +0.40 cm H 2 O (-0.30, 1.12) with Hudson prongs,  p  = 0.0002.
CONCLUSION


For given set CPAP pressure level in preterm infants, the RAM cannula system consistently delivers lower pharyngeal pressure (effective CPAP) levels than Hudson prongs.",2019,"For given set CPAP pressure level in preterm infants, the RAM cannula system consistently delivers lower pharyngeal pressure (effective CPAP) levels than Hudson prongs.","['preterm infants with respiratory distress', 'preterm infants', 'convenience sample of preterm infants with respiratory distress requiring treatment with CPAP', '12 preterm infants with mean (standard deviation) birth weight of 1,225 (405) g and gestational age of 28.4 (2.1) weeks at a median postnatal age of 10 days']","['continuous positive airway pressure (CPAP) delivered by the RAM cannula system (Neotech, Valencia, CA) with that delivered by a traditional CPAP nasal delivery interface (Hudson prongs; Hudson-RCI, Temecula, CA']","['set CPAP levels and the measured intraoral pressures of both delivery systems', 'mean intraoral (pharyngeal) pressure', 'CPAP level and measured intraoral pressure', 'pharyngeal pressure (effective CPAP) levels']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress (finding)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]","[{'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0442119', 'cui_str': 'Intraoral approach (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0449914', 'cui_str': 'Delivery system (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}]",12.0,0.0715918,"For given set CPAP pressure level in preterm infants, the RAM cannula system consistently delivers lower pharyngeal pressure (effective CPAP) levels than Hudson prongs.","[{'ForeName': 'Neetu', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'McNally', 'Affiliation': 'Department of Respiratory Therapy, Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Darnall', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire.'}]",American journal of perinatology,['10.1055/s-0038-1675330']
3313,32078392,Respiratory-Swallow Coordination Training and Voluntary Cough Skill Training: A Single-Subject Treatment Study in a Person With Parkinson's Disease.,"Purpose Airway protective disorders are common in Parkinson's disease (PD), yet effective methods to rehabilitate these life-threatening impairments are limited. This study examined the effects of two skill-based treatments aimed at improving swallowing and cough in a severely dysphagic person with PD: respiratory-swallow coordination training (RSCT) and voluntary cough skill training (VCST). It was hypothesized that (a) RSCT would improve respiratory-swallow coordination and swallowing safety and efficiency and (b) VCST would improve reflex and voluntary cough effectiveness. Method An 81-year-old man with midstage PD and severe dysphagia was recruited for study participation. The study utilized a multiple-baseline ABACA experimental design with a 2-month delayed retention assessment. Measures of respiratory-swallow coordination, swallowing safety and efficiency, and cough effectiveness were collected at each assessment using respiratory inductive plethysmography, flexible endoscopic evaluations of swallowing, and spirometry. Data were analyzed descriptively using baseline corrected tau and standard mean difference effect sizes ( d ). Results Large effect sizes were observed immediately following RSCT for respiratory-swallow coordination ( d  = 9.17), penetration-aspiration ( d  = 12.88), vallecular residue ( d  = 1.75), piriform residue ( d  = 4.15), and overall dysphagia severity ( d  = 1.83). Large effect sizes were also observed immediately following VCST for single voluntary cough ( d  = 4.30), sequential voluntary cough ( d  = 3.28), and reflex cough ( d  = 5.58). Improvements were maintained 2 months later for all outcome measures except single voluntary cough. Discussion This is the first study to examine the effects of RSCT and VCST in a person with PD. Robust improvements in respiratory-swallow coordination and swallowing safety and efficiency were achieved following four sessions of RSCT, and significant improvements in reflex and voluntary cough strength were seen following four sessions of VCST. Future work is needed to study these treatments in larger cohorts of people with PD.",2020,"Robust improvements in respiratory-swallow coordination and swallowing safety and efficiency were achieved following four sessions of RSCT, and significant improvements in reflex and voluntary cough strength were seen following four sessions of VCST.","['larger cohorts of people with PD', 'severely dysphagic person with PD: respiratory', 'person with PD', ""Parkinson's disease (PD"", ""Person With Parkinson's Disease"", '81-year-old man with midstage PD and severe dysphagia']","['Respiratory-Swallow Coordination Training and Voluntary Cough Skill Training', 'VCST', 'RSCT and VCST', 'swallow coordination training (RSCT) and voluntary cough skill training (VCST', 'RSCT']","['single voluntary cough', 'reflex cough', 'vallecular residue', 'respiratory-swallow coordination and swallowing safety and efficiency', 'penetration-aspiration', 'respiratory inductive plethysmography, flexible endoscopic evaluations of swallowing, and spirometry', 'reflex and voluntary cough strength', 'overall dysphagia severity', 'sequential voluntary cough', 'reflex and voluntary cough effectiveness', 'swallowing and cough', 'respiratory-swallow coordination, swallowing safety and efficiency, and cough effectiveness']","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205086', 'cui_str': 'Midstage (qualifier value)'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}]","[{'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0419112', 'cui_str': 'Coordination training'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C0032221', 'cui_str': 'Plethysmography'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C4708767', 'cui_str': 'Strength of cough (observable entity)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0011167', 'cui_str': 'Swallowing'}]",,0.0175754,"Robust improvements in respiratory-swallow coordination and swallowing safety and efficiency were achieved following four sessions of RSCT, and significant improvements in reflex and voluntary cough strength were seen following four sessions of VCST.","[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Curtis', 'Affiliation': 'Laboratory for the Study of Upper Airway Dysfunction, Department of Biobehavioral Sciences, Teachers College, Columbia University, New York, NY.'}, {'ForeName': 'Avery E', 'Initials': 'AE', 'LastName': 'Dakin', 'Affiliation': 'Laboratory for the Study of Upper Airway Dysfunction, Department of Biobehavioral Sciences, Teachers College, Columbia University, New York, NY.'}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Troche', 'Affiliation': 'Laboratory for the Study of Upper Airway Dysfunction, Department of Biobehavioral Sciences, Teachers College, Columbia University, New York, NY.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2019_JSLHR-19-00207']
3314,32112555,Music Therapy for Preterm Infants and Their Parents: A Cluster-Randomized Controlled Trial Protocol.,"Music therapy (MT) interventions and skin-to-skin care (SSC) both aim to address the varied needs of preterm infants, including sensory regulation and stress reduction, inclusion of parents in their infant's care, support of parents' emotional state, and enhancing the parent-infant attachment process. Few studies have investigated the combination of both modalities through randomized controlled trials. Evidence of longer-term effects is missing. This article presents a study protocol that will investigate the effects of combined family-centered MT intervention and SSC on preterm-infants' autonomic nervous system (ANS) stability, parental anxiety levels, and parent-infant attachment quality. 12 clusters with a total of 72 preterm infants, with their parents, will be randomized to one of two conditions: MT combined with SSC or SSC alone. Each parent-infant dyad will participate in 3 sessions (2 in the hospital and a 3-month follow-up). The primary outcome of preterm infants' ANS stability will be measured by the high frequency power of their heart rate variability. Secondary outcomes will be physiological measures and behavioral states in infants and anxiety and attachment levels of parents. This trial will provide important, evidence-based knowledge on the use of the ""First Sounds: Rhythm, Breath, and Lullaby"" model of MT in neonatal care, through an intervention that is in line with the Newborn Individualized Developmental Care and Assessment Program model for supportive developmental care of preterm infants and their parents. Ethical approval (no. 0283-15) was granted from the local Institutional Review Board in April 2017. This trial is registered in ClinicalTrials.gov, NCT03023267.",2020,"12 clusters with a total of 72 preterm infants, with their parents, will be randomized to one of two conditions: MT combined with SSC or SSC alone.","['12 clusters with a total of 72 preterm infants, with their parents', 'preterm infants and their parents', 'Preterm Infants and Their Parents']","['Music therapy (MT) interventions and skin-to-skin care (SSC', 'MT combined with SSC or SSC alone', 'combined family-centered MT intervention and SSC', 'Music Therapy']","['physiological measures and behavioral states in infants and anxiety and attachment levels of parents', ""preterm infants' ANS stability will be measured by the high frequency power of their heart rate variability"", ""preterm-infants' autonomic nervous system (ANS) stability, parental anxiety levels, and parent-infant attachment quality""]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C0026868', 'cui_str': 'Music Therapy'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0150773', 'cui_str': 'Skin Care'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0004388', 'cui_str': 'Visceral Nervous System'}, {'cui': 'C0577602', 'cui_str': 'Parental anxiety (finding)'}, {'cui': 'C0518098', 'cui_str': 'Parent-infant attachment'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",72.0,0.160944,"12 clusters with a total of 72 preterm infants, with their parents, will be randomized to one of two conditions: MT combined with SSC or SSC alone.","[{'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Yakobson', 'Affiliation': 'Department of Communication and Psychology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Shmuel', 'Initials': 'S', 'LastName': 'Arnon', 'Affiliation': 'Neonatal Department, Meir Medical Center, Kfar-Saba, IsraelTel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gold', 'Affiliation': 'GAMUT, Uni Research Health, Uni Research, Bergen, Norway.'}, {'ForeName': 'Cochavit', 'Initials': 'C', 'LastName': 'Elefant', 'Affiliation': 'School for Creative Arts Therapies, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Ita', 'Initials': 'I', 'LastName': 'Litmanovitz', 'Affiliation': 'Neonatal Department, Meir Medical Center, Kfar-Saba, IsraelTel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Bolette Daniels', 'Initials': 'BD', 'LastName': 'Beck', 'Affiliation': 'Department of Communication and Psychology, Aalborg University, Aalborg, Denmark.'}]",Journal of music therapy,['10.1093/jmt/thaa002']
3315,32037213,The James A. Rand Young Investigator's Award: Traditional Intravenous Fluid vs. Oral Fluid Administration in Primary Total Knee Arthroplasty: A Randomized Trial.,"BACKGROUND


Optimal perioperative fluid management has not been established in patients undergoing orthopedic surgical procedures. Our purpose was to investigate the effects of perioperative fluid management (ie, preoperative, intraoperative, and postoperative) on patients undergoing total knee arthroplasty (TKA).
METHODS


One hundred thirty patients who met inclusion criteria undergoing primary unilateral TKA were prospectively randomized into traditional (TFG) vs oral (OFG) perioperative fluid management groups. The primary outcome was change in body weight (BW). Secondary outcome measures included knee motion, leg girth, bioelectrical impendence, quadriceps activation, functional outcomes testing, Knee injury and Osteoarthritis Outcome Score JR, VR-12, laboratory values, vital signs, patient satisfaction, pain scores, and adverse events.
RESULTS


The TFG had increased BW the evening of surgery (7.0 ± 4.3 vs 3.0 ± 3.9, P < .0001), postoperative day (POD) #1 (9.1 ± 4.3 vs 4.7 ± 3.9, P < .0001), and POD #2 (6.2 ± 5.0 vs 4.4 ± 4.0, P = .032). Bioelectrical impedance showed less limb edema in the OFG (4.2 ± 29.7 vs 17.8 ± 30.3, P < .0001) on POD #1. Urine specific gravity differences were seen preoperatively between groups (OFG, more hydrated, P = .002). Systolic blood pressure decrease from the baseline was greater in the OFG on arrival to the floor (19.4 ± 13.5 vs 10.6 ± 12.8, P < .0001) and 8 (23.4 ± 13.3 vs 17.0 ± 12.9, P = .006) and 16 (25.8 ± 13.8 vs 25.8 ± 13.8, P = .046) hours after floor arrival. The TFG had more urine output on POD #1 (3369 mL ± 1343 mL vs 2435 mL ± 1151 mL, P < .0001). The OFG were more likely to go home on POD #1 than the TFG (63 vs 56, P = .02).
CONCLUSION


Oral fluid intake with IVF restriction in the perioperative period after TKA may offer short-term benefits with swelling and BW fluctuations. The authors continue to limit perioperative IVFs and encourage patient initiated fluid intake.",2020,"Urine specific gravity differences were seen preoperatively between groups (OFG, more hydrated, P = .002).","['patients undergoing total knee arthroplasty (TKA', 'One hundred thirty patients who met inclusion criteria undergoing primary unilateral TKA', 'patients undergoing orthopedic surgical procedures', 'Primary Total Knee Arthroplasty']","['traditional (TFG) vs oral (OFG) perioperative fluid management groups', 'Traditional Intravenous Fluid Versus Oral Fluid Administration', 'TFG', 'perioperative fluid management (ie, preoperative, intraoperative, and postoperative']","['knee motion, leg girth, bioelectrical impendence, quadriceps activation, functional outcomes testing, Knee injury and Osteoarthritis Outcome Score JR, VR-12, laboratory values, vital signs, patient satisfaction, pain scores, and adverse events', 'Systolic blood pressure decrease', 'limb edema', 'Urine specific gravity differences', 'postoperative day (POD', 'change in body weight (BW']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C1136201', 'cui_str': 'Orthopedic Surgical Procedures'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0553741', 'cui_str': 'Hydration control'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0518766'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0587361', 'cui_str': 'Specific gravity of urine (finding)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",130.0,0.196637,"Urine specific gravity differences were seen preoperatively between groups (OFG, more hydrated, P = .002).","[{'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Jennings', 'Affiliation': 'Colorado Joint Replacement, Porter Adventist Hospital, Denver, CO; Department of Mechanical and Materials Engineering, University of Denver, Denver, CO.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Mejia', 'Affiliation': 'US Anesthesia Partners, Denver, CO.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Williams', 'Affiliation': 'Porter Adventist Hospital, Denver, CO.'}, {'ForeName': 'Roseann M', 'Initials': 'RM', 'LastName': 'Johnson', 'Affiliation': 'Colorado Joint Replacement, Porter Adventist Hospital, Denver, CO.'}, {'ForeName': 'Charlie C', 'Initials': 'CC', 'LastName': 'Yang', 'Affiliation': 'Colorado Joint Replacement, Porter Adventist Hospital, Denver, CO.'}, {'ForeName': 'Douglas A', 'Initials': 'DA', 'LastName': 'Dennis', 'Affiliation': 'Colorado Joint Replacement, Porter Adventist Hospital, Denver, CO; Department of Mechanical and Materials Engineering, University of Denver, Denver, CO; Department of Orthopaedics, University of Colorado School of Medicine, Denver, CO; Department of Biomedical Engineering, University of Tennessee, Knoxville, TN.'}]",The Journal of arthroplasty,['10.1016/j.arth.2020.01.029']
3316,31405924,Distinct Roles of Dopamine and Noradrenaline in Incidental Memory.,"Episodic memory is sensitive to the influence of neuromodulators, such as dopamine and noradrenaline. These influences are considered important in the expression of several known memory biases, though their specific role in memory remains unclear. Using pharmacological agents with relatively high selectivity for either dopamine (400 mg amisulpride) or noradrenaline (40 mg propranolol) we examined their specific contribution to incidental memory. In a double-blind placebo-controlled human study (30 females, 30 males in total), we show that a memory selectivity bias was insensitive to propranolol but sensitive to amisulpride, consistent with a dominant influence from dopamine. By contrast, a putative arousal-induced memory boosting effect was insensitive to amisulpride but was sensitive to propranolol, consistent with a dominant noradrenaline effect. Thus, our findings highlight specific functional roles for dopamine and noradrenaline neurotransmission in the expression of incidental memory. SIGNIFICANCE STATEMENT  Why some information is preferentially encoded into memory while other information is not is a central question in cognitive neuroscience. The neurotransmitters dopamine and noradrenaline are often assumed critical in influencing this selectivity, but their specific contributions remain obscure. In this double-blind, placebo-controlled, between-subjects drug study, we investigate the contributions of noradrenaline and dopamine to episodic memory. Using an incidental memory task, we find that blocking dopamine (400 mg amisulpride) eliminates a neural-gain related memory selectivity bias. Blocking noradrenaline function (40 mg propranolol), in contrast, abolishes an arousal-related memory enhancement. In this assessment of dopamine and noradrenaline neuromodulatory effects we reveal their specific contributions to episodic memory.",2019,Using pharmacological agents with relatively high selectivity for either dopamine (400mg amisulpride) or noradrenaline (40mg propranolol) we examined their specific contribution to incidental memory.,"['incidental memory', 'controlled human study (30 females, 30 males in total']","['dopamine (400mg amisulpride) or noradrenaline (40mg propranolol', 'Blocking noradrenaline function (40mg propranolol', 'dopamine and noradrenaline', 'placebo', 'propranolol', 'blocking dopamine (400mg amisulpride', 'amisulpride']",['putative arousal-induced memory boosting effect'],"[{'cui': 'C0444507', 'cui_str': 'Incidental (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0103045', 'cui_str': 'Amisulpride'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.0524336,Using pharmacological agents with relatively high selectivity for either dopamine (400mg amisulpride) or noradrenaline (40mg propranolol) we examined their specific contribution to incidental memory.,"[{'ForeName': 'Tobias U', 'Initials': 'TU', 'LastName': 'Hauser', 'Affiliation': 'Max Planck University College London Centre for Computational Psychiatry and Ageing Research, London WC1B 5EH, United Kingdom, t.hauser@ucl.ac.uk.'}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Eldar', 'Affiliation': 'Max Planck University College London Centre for Computational Psychiatry and Ageing Research, London WC1B 5EH, United Kingdom.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Purg', 'Affiliation': 'Max Planck University College London Centre for Computational Psychiatry and Ageing Research, London WC1B 5EH, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Moutoussis', 'Affiliation': 'Max Planck University College London Centre for Computational Psychiatry and Ageing Research, London WC1B 5EH, United Kingdom.'}, {'ForeName': 'Raymond J', 'Initials': 'RJ', 'LastName': 'Dolan', 'Affiliation': 'Max Planck University College London Centre for Computational Psychiatry and Ageing Research, London WC1B 5EH, United Kingdom.'}]",The Journal of neuroscience : the official journal of the Society for Neuroscience,['10.1523/JNEUROSCI.0401-19.2019']
3317,32108253,"Immediate effects of an elastic patellar brace on pain, neuromuscular activity and knee kinematics in subjects with patellofemoral pain.","INTRODUCTION


The aim of this randomized controlled trial was to investigate immediate effects of a patellar brace on pain, neuromuscular activity, and knee kinematics in subjects with patellofemoral pain syndrome.
MATERIALS AND METHODS


Fifty subjects with a diagnosis of patellofemoral pain syndrome completed 6 activities each with and without a patellar brace in a randomized order. The subjects were asked to rate their perceived pain on a Visual Analog Scale after each activity. During the activities, neuromuscular activity of vastus medialis and vastus lateralis, as well as knee angles were measured.
RESULTS


Subjects showed a statistically significant pain reduction of 33-56% on the Visual Analog Scale during all activities while wearing the brace. Two groups with different onset patterns for vastus medialis and vastus lateralis were identified: one group who activated vastus medialis prior to vastus lateralis, and one who activated vastus medialis after vastus lateralis. In the subgroup of subjects activating vastus lateralis prior to vastus medialis, bracing resulted in a significantly (p = 0.048) earlier onset of vastus medialis by 56 ms. In all but one activity, the vastus medialis/vastus lateralis ratio without the patellar brace was < 1.0 and inverted with the patellar brace > 1.0. Knee angles in the sagittal plane increased significantly with the patellar brace in two activities.
CONCLUSION


Patellofemoral bracing results in an immediate decrease of pain, an earlier onset of vastus medialis and inverted vastus medialis/vastus lateralis ratio and altered knee kinematics.",2020,"RESULTS


Subjects showed a statistically significant pain reduction of 33-56% on the Visual Analog Scale during all activities while wearing the brace.","['Fifty subjects with a diagnosis of patellofemoral pain syndrome completed 6 activities each with and without a patellar brace in a randomized order', 'subjects with patellofemoral pain syndrome', 'subjects with patellofemoral pain']","['elastic patellar brace', 'patellar brace']","['rate their perceived pain on a Visual Analog Scale', 'pain reduction', 'vastus medialis/vastus lateralis ratio without the patellar brace', 'Visual Analog Scale', 'pain, an earlier onset of vastus medialis and inverted vastus medialis/vastus lateralis ratio and altered knee kinematics', 'pain, neuromuscular activity and knee kinematics', 'pain, neuromuscular activity, and knee kinematics']","[{'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0877149', 'cui_str': 'Patellofemoral Pain Syndrome'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0006086', 'cui_str': 'Braces'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0006086', 'cui_str': 'Braces'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0224445', 'cui_str': 'Vastus Medialis'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0006086', 'cui_str': 'Braces'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C4522321', 'cui_str': 'Inverted (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",50.0,0.0227973,"RESULTS


Subjects showed a statistically significant pain reduction of 33-56% on the Visual Analog Scale during all activities while wearing the brace.","[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Kölle', 'Affiliation': 'Institut für Rehabilitationsmedizinische Forschung an der Universität Ulm, Am Kurpark 1, 88422, Bad Buchau, Germany. theresa.koelle@ifr-ulm.de.'}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'Alt', 'Affiliation': 'Institut für Sport- und Bewegungswissenschaft, Universität Stuttgart, Allmandring 28, 70569, Stuttgart, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wagner', 'Affiliation': 'Hessingpark Clinic, Hessingstrasse 17, 86199, Augsburg, Germany.'}]",Archives of orthopaedic and trauma surgery,['10.1007/s00402-020-03378-7']
3318,32044651,Oxytocin modulates responsibility attribution and hypothetical Resource allocation during cooperation.,"Reasonable responsibility attribution and resource allocation in intragroup contexts benefit the evolution of group cooperation. Oxytocin (OT) has been shown to promote prosocial behavior; however, it remains unclear whether OT affects responsibility attribution and hypothetical resource allocation. In the present study, participants were intranasally administered OT or placebo (PLC) before a response task with a partner. The participant could win a certain amount of money depending on the group's performance, which was determined by the faster player. The contribution was manipulated to be similar in the first phase, while the participants could individually contribute more in the second phase. Our results show that both groups attributed more credit to the player who performed better in a trial. Moreover, reward magnitude only enhanced effort-based attribution in the OT group. Although both groups proposed to distribute money based on individual efforts, the PLC group increased their effort-based allocation when they contributed more, regardless of the fact that the money was eventually equally distributed. Our study demonstrates that OT modulates responsibility attribution and hypothetical resource allocation in different manners, suggesting that OT has different effects on a participant's perception of individual contribution and fairness when allocating a reward during social cooperation in a real effort task.",2020,"Moreover, reward magnitude only enhanced effort-based attribution in the OT group.",[],"['OT', 'OT or placebo (PLC', 'Oxytocin', 'Oxytocin (OT']",[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]",[],,0.0338998,"Moreover, reward magnitude only enhanced effort-based attribution in the OT group.","[{'ForeName': 'Shiyao', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Brain Function and Psychological Science Research Center, Shenzhen University, Shenzhen, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Xu', 'Affiliation': 'Brain Function and Psychological Science Research Center, Shenzhen University, Shenzhen, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Brain Function and Psychological Science Research Center, Shenzhen University, Shenzhen, China; Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, China. Electronic address: peng@szu.edu.cn.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104597']
3319,32091670,Musculoskeletal adaptations to strength training in frail elderly: a matter of quantity or quality?,"BACKGROUND


The improvement in muscle strength generally exceeds the increase in muscle size following strength training in frail elderly, highlighting the complex aetiology of strength deficit in aging. The aim of this study was to investigate the effect of heavy-load strength training on a broad number of factors related to specific strength in frail elderly.
METHODS


Thirty-four frail elderly men (n = 18) and women (n = 16) aged 67 to 98 (86 ± 7 years) were randomized to either a group performing strength training twice a week for 10 weeks (ST) or a non-exercising control group (CON). Knee extensor muscle strength was tested as one-repetition maximum (1RM) and isometric maximal voluntary contraction (MVC) torque. Muscle activation was assessed by the interpolated twitch technique, and muscle density [mean Hounsfield units (HU)] and intermuscular adipose tissue (IMAT) by computed tomography scans of the quadriceps femoris. Muscle biopsies from the vastus lateralis were obtained to investigate changes in intramyocellular lipids and single-fibre specific tension.
RESULTS


In ST, knee extension 1RM and MVC improved by 17 and 7%, respectively. Muscle cross-sectional area of the quadriceps femoris increased by 7%, accompanied by a 4% increase of muscle density. No changes in IMAT, voluntary activation level, single-fibre specific tension, or lipid content were observed.
CONCLUSIONS


In contrast to several previous reports, the improvements in isometric muscle strength and muscle area were in good agreement in the present study. The training-induced increase in muscle density was not due to changes in skeletal muscle lipid content. Instead, the increase in muscle density may reflect increased packing of contractile material or simply an increased ratio of muscle tissue relative to IMAT.",2020,"Muscle cross-sectional area of the quadriceps femoris increased by 7%, accompanied by a 4% increase of muscle density.","['frail elderly', 'Thirty-four frail elderly men (n = 18) and women (n = 16) aged 67 to 98 (86 ± 7 years']","['strength training twice a week for 10 weeks (ST) or a non-exercising control group (CON', 'heavy-load strength training', 'strength training']","['repetition maximum (1RM) and isometric maximal voluntary contraction (MVC) torque', 'Muscle activation', 'muscle density', 'interpolated twitch technique, and muscle density [mean Hounsfield units (HU)] and intermuscular adipose tissue (IMAT', 'Knee extensor muscle strength', 'skeletal muscle lipid content', 'IMAT, voluntary activation level, single-fibre specific tension, or lipid content', 'knee extension 1RM and MVC', 'isometric muscle strength and muscle area', 'Muscle cross-sectional area of the quadriceps femoris']","[{'cui': 'C0079377', 'cui_str': 'Frail Elders'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch (finding)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0233494', 'cui_str': 'Tension (finding)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}]",34.0,0.011672,"Muscle cross-sectional area of the quadriceps femoris increased by 7%, accompanied by a 4% increase of muscle density.","[{'ForeName': 'Sigve N', 'Initials': 'SN', 'LastName': 'Aas', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, Sognsveien, Oslo, Norway.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Breit', 'Affiliation': 'Department of Sport and Exercise Physiology, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Stian', 'Initials': 'S', 'LastName': 'Karsrud', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, Sognsveien, Oslo, Norway.'}, {'ForeName': 'Ole J', 'Initials': 'OJ', 'LastName': 'Aase', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, Sognsveien, Oslo, Norway.'}, {'ForeName': 'Simen H', 'Initials': 'SH', 'LastName': 'Rognlien', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, Sognsveien, Oslo, Norway.'}, {'ForeName': 'Kristoffer T', 'Initials': 'KT', 'LastName': 'Cumming', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, Sognsveien, Oslo, Norway.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Reggiani', 'Affiliation': 'Department of Biomedical Sciences, University of Padua, Padua, Italy.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Seynnes', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, Sognsveien, Oslo, Norway.'}, {'ForeName': 'Andrea P', 'Initials': 'AP', 'LastName': 'Rossi', 'Affiliation': 'Section of Geriatrics, Department of Medicine, University of Verona, Verona, Italy.'}, {'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Toniolo', 'Affiliation': 'Department of Biomedical Sciences, University of Padua, Padua, Italy.'}, {'ForeName': 'Truls', 'Initials': 'T', 'LastName': 'Raastad', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, Sognsveien, Oslo, Norway.'}]","Journal of cachexia, sarcopenia and muscle",['10.1002/jcsm.12543']
3320,32070797,Oxytocin alters the effect of payoff but not base rate in emotion perception.,"Emotion perception, inferring the emotional state of another person, can be formalized as decision under uncertainty: another person's scowling face may indicate anger or concentration and the optimal inference is contingent on the decision consequences (payoff) and how likely real anger is encountered (base rate). Although emerging evidence suggests that the neuropeptide oxytocin influences human perception of emotional facial expressions, whether such effect relates to the alternated process of payoff or base rate still remains unclear. In addition, little is known about oxytocin's effect on metacognitive process involved in emotion perception. One hundred and twenty-two healthy male adults (sixty-two in Experiment 1 and sixty in Experiment 2, respectively) received 24 international units (IU) of intranasal oxytocin or placebo (between-subjects) in a randomized and double-blind study. We independently and systematically manipulated the payoff and base rate levels in an emotion categorization task and measured participants' response bias via categorization choice and metacognitive sensitivity via confidence report. Compared to the placebo group, oxytocin specifically induced a categorization bias under the payoff, but not base rate manipulation. In contrast, oxytocin had no effect on subjects' confidence rating, indicating that the metacognitive sensitivity can be dissociated from emotion perception. Our results pinpoint the specific role of oxytocin in payoff evaluation, but not target likelihood estimation and provide a potential theoretical framework to bridge oxytocin research in emotion perception, social cognition and value-based decisions.",2020,"Compared to the placebo group, oxytocin specifically induced a categorization bias under the payoff, but not base rate manipulation.","['One hundred and twenty-two healthy male adults (sixty-two in Experiment 1 and sixty in Experiment 2, respectively) received 24 international units (IU) of']","['neuropeptide oxytocin', 'placebo', 'Oxytocin', 'intranasal oxytocin or placebo', 'oxytocin']","['Emotion perception', ""subjects' confidence rating"", 'emotional facial expressions', 'emotion perception']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0686751', 'cui_str': 'Well male adult (finding)'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0439453', 'cui_str': 'IU'}]","[{'cui': 'C0027895', 'cui_str': 'Neuropeptides'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}]","[{'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0015457', 'cui_str': 'Facial Expression'}]",122.0,0.143084,"Compared to the placebo group, oxytocin specifically induced a categorization bias under the payoff, but not base rate manipulation.","[{'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'School of Psychology and Beijing, Key Lab of Learning and Cognition, Capital Normal University, Beijing, China. Electronic address: qwu@cnu.edu.cn.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Mao', 'Affiliation': 'School of Psychological and Cognitive Sciences and Beijing, Key Laboratory of Behavior and Mental Health, Peking University, Beijing, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'School of Psychological and Cognitive Sciences and Beijing, Key Laboratory of Behavior and Mental Health, Peking University, Beijing, China. Electronic address: li.jian@pku.edu.cn.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104608']
3321,31989240,Acute and daily effects of repeated voluntary hyperpnea on pulmonary function in healthy adults.,"PURPOSE


Hyperpnea training has been used as a method for both improving exercise performance in healthy persons and improving ventilatory capacity in patients with pulmonary disease. However, voluntary hyperpnea causes acute declines in pulmonary function, but the effects of repeated days of hyperpnea on airway function are not known. The purpose of this study was to determine the effects of repeated normocapnic hyperpnea on daily and post-hyperpnea pulmonary function in healthy adults.
METHODS


Ten healthy adults (21 years; 170 cm; 66 kg) completed ten hyperpnea training sessions within 17-days (TR). Training sessions consisted of 20-minutes of normocapnic hyperpnea with gradually increased minute ventilation over the 10 days. Spirometry was assessed at baseline and serially following hyperpnea during each experimental day. A control group (24 years; 171 cm; 66 kg) completed 10 days of spirometry with no hyperpnea training (CON).
RESULTS


In both CON and TR subjects, baseline pulmonary function was unchanged during the 10 days. In TR subjects, pulmonary function was decreased at 5 mins after hyperpnea but thereafter increased to pre-hyperpnea values by 30 mins. Furthermore, these changes in pulmonary function were consistent during the 10 training days. In TR subjects, maximal voluntary ventilation decreased by 10.4 ± 8.9% (168-150 L min -1 ) over the 10 days (P < 0.05), whereas it was unchanged in CON subjects.
CONCLUSIONS


These findings demonstrate that voluntary hyperpnea acutely decreases airway function in healthy subjects. However, there does not appear to be a cumulative effect of repeated hyperpnea, as daily pulmonary function was unchanged.",2020,"In TR subjects, maximal voluntary ventilation decreased by 10.4 ± 8.9% (168-150 L min -1 ) over the 10 days (P < 0.05), whereas it was unchanged in CON subjects.
","['healthy adults', 'healthy persons', 'patients with pulmonary disease', 'healthy subjects', 'Ten healthy adults (21\xa0years; 170\xa0cm; 66\xa0kg) completed ten']","['repeated voluntary hyperpnea', 'repeated normocapnic hyperpnea', 'Hyperpnea training', 'spirometry with no hyperpnea training (CON', 'voluntary hyperpnea', 'hyperpnea training sessions within 17-days (TR']","['minute ventilation', 'maximal voluntary ventilation', 'exercise performance', 'pulmonary function', 'baseline pulmonary function', 'airway function']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024115', 'cui_str': 'Pulmonary Diseases'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0220854', 'cui_str': 'Hyperpnea (finding)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C1384388', 'cui_str': 'Maximum breathing capacity, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",10.0,0.0236597,"In TR subjects, maximal voluntary ventilation decreased by 10.4 ± 8.9% (168-150 L min -1 ) over the 10 days (P < 0.05), whereas it was unchanged in CON subjects.
","[{'ForeName': 'Eden', 'Initials': 'E', 'LastName': 'Towers', 'Affiliation': 'Department of Environmental and Health Sciences, Northern Vermont University-Johnson, 337 College Hill Road, Johnson, VT, 05405, USA.'}, {'ForeName': 'Adriane', 'Initials': 'A', 'LastName': 'Morrison-Taylor', 'Affiliation': 'Department of Environmental and Health Sciences, Northern Vermont University-Johnson, 337 College Hill Road, Johnson, VT, 05405, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Demar', 'Affiliation': 'Department of Environmental and Health Sciences, Northern Vermont University-Johnson, 337 College Hill Road, Johnson, VT, 05405, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Klansky', 'Affiliation': 'Department of Environmental and Health Sciences, Northern Vermont University-Johnson, 337 College Hill Road, Johnson, VT, 05405, USA.'}, {'ForeName': 'Kasie', 'Initials': 'K', 'LastName': 'Craig', 'Affiliation': 'Department of Environmental and Health Sciences, Northern Vermont University-Johnson, 337 College Hill Road, Johnson, VT, 05405, USA.'}, {'ForeName': 'Hans Christian', 'Initials': 'HC', 'LastName': 'Haverkamp', 'Affiliation': 'Department of Nutrition and Exercise Physiology, Elson S. Floyd College of Medicine, Washington State University, PO Box 1495, Spokane, WA, 99210-1495, USA. hans.haverkamp@wsu.edu.'}]",European journal of applied physiology,['10.1007/s00421-020-04302-y']
3322,32091400,Short-duration triple antithrombotic therapy for atrial fibrillation patients who require coronary stenting: results of the SAFE-A study.,"AIMS


We aimed to determine whether shortening the duration of P2Y12 inhibitor therapy can reduce the risk of bleeding without increasing the risk of major adverse cardiovascular events following coronary stenting in patients with atrial fibrillation (AF).
METHODS AND RESULTS


The SAFE-A is a randomised controlled trial that compared one-month and six-month P2Y12 inhibitor therapy, in combination with aspirin and apixaban for patients with AF who require coronary stenting. The primary endpoint was the incidence of any bleeding events, defined as Thrombolysis In Myocardial Infarction major/minor bleeding, bleeding with various Bleeding Academic Research Consortium grades, or bleeding requiring blood transfusion within 12 months after stenting. The study aimed to enrol 600 patients but enrolment was slow. Enrolment was terminated prematurely after enrolling 210 patients (72.7±8.2 years; 81% male). The incidence of the primary endpoint did not differ between the one-month and six-month groups (11.8% vs 16.0%; hazard ratio [HR] 0.70, 95% confidence interval [CI]: 0.33-1.47; p=0.35).
CONCLUSIONS


The study evaluated the safety of withdrawing the P2Y12 inhibitor from triple antithrombotic prescription one month after coronary stenting. However, enrolment was prematurely terminated because it was slow. Therefore, statistical power was not sufficient to assess the differences in the primary endpoint.",2020,"The incidence of the primary endpoint did not differ between the 1-month and 6-month groups (11.8% vs 16.0%; hazard ratio, 0.70; 95% confidence interval, 0.33-1.47; P = 0.35).
","['Atrial Fibrillation Patients', 'patients with atrial fibrillation (AF', 'patients with AF who require coronary stenting', 'enroll 600 patients, but enrollment was slow', 'Enrollment was terminated prematurely after enrolling 210 patients (72.7±8.2 years; 81% men']","['aspirin and apixaban', 'coronary stenting', 'Short-Duration Triple Antithrombotic Therapy', 'Coronary Stenting']","['incidence of any bleeding events, defined as Thrombosis in Myocardial Infarction with major/minor bleeding, bleeding with various Bleeding Academic Research Consortium grades, or bleeding requiring blood transfusion']","[{'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0035168'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}]",210.0,0.107523,"The incidence of the primary endpoint did not differ between the 1-month and 6-month groups (11.8% vs 16.0%; hazard ratio, 0.70; 95% confidence interval, 0.33-1.47; P = 0.35).
","[{'ForeName': 'Tomoya', 'Initials': 'T', 'LastName': 'Hoshi', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, University of Tsukuba, Tsukuba City, Ibaraki, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Sato', 'Affiliation': ''}, {'ForeName': 'Daigo', 'Initials': 'D', 'LastName': 'Hiraya', 'Affiliation': ''}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Watabe', 'Affiliation': ''}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Takeyasu', 'Affiliation': ''}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Nogami', 'Affiliation': ''}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Ohigashi', 'Affiliation': ''}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Gosho', 'Affiliation': ''}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Ieda', 'Affiliation': ''}, {'ForeName': 'Kazutaka', 'Initials': 'K', 'LastName': 'Aonuma', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-19-00920']
3323,32066460,"Effects of high vs moderate-intensity intermittent training on functionality, resting heart rate and blood pressure of elderly women.","BACKGROUND


The present study compared the effects of training and detraining periods of high-intensity interval training (HIIT), moderate-intensity interval training (MIIT) and moderate-intensity continuous training (MICT) on functional performance, body composition, resting blood pressure and heart rate in elderly women nursing home residents.
METHODS


Forty-six volunteers (age, 80.8 ± 5.2 y; body mass, 69.8 ± 5.2 kg, height, 164.2 ± 4.12 cm) were divided into groups that performed treadmill exercise twice-weekly HIIT (4 bouts of 4-min intervals at 85-95% of the maximal heart rate [HR max ], interspersed by 4 min at 65% HR max ), MIIT (4 bouts of 4 min intervals at 55-75% HR max , interspersed by 4 min at 45-50% HR max ) and MICT (30-min at 55-75% HR max ). Tests were performed before and after 8 weeks of training and 2 and 4 weeks of detraining. ANCOVA was used to analyze dependent variable changes.
RESULTS


After 8 weeks HIIT promoted greater reductions in body mass (HIIT = - 1.6 ± 0.1 kg; MICT = - 0.9 ± 0.1 kg; MIIT = - 0.9 ± 0.1 kg; p = 0.001), fat mass (HIIT = - 2.2 ± 0.1%; MICT = - 0.7 ± 0.1%; MIIT = - 1.2 ± 0.1%; p < 0.001) and resting heart rate (HIIT = - 7.3 ± 0.3%; MICT = - 3.6 ± 0.3%; MIIT = - 5.1 ± 0.3%; p < 0.001) and greater improvement in the chair stand test (HIIT = 3.4 ± 0.1 reps; MICT = 2.5 ± 0.1 reps; MIIT = 3.1 ± 0.1 reps; p < 0.001) when compared to MIIT and MICT. These improvements were sustained after 2 and 4 weeks of detraining only in the HIIT group.
CONCLUSION


HIIT promoted greater benefits for body composition and functional performance than MICT and MIIT and also showed less pronounced effects of detraining. This suggests that the intensity of physical exercise is an important factor to consider when prescribing exercise to the elderly.",2020,HIIT promoted greater benefits for body composition and functional performance than MICT and MIIT and also showed less pronounced effects of detraining.,"['elderly women nursing home residents', 'Forty-six volunteers (age, 80.8\u2009±\u20095.2 y; body mass, 69.8\u2009±\u20095.2\xa0kg, height, 164.2\u2009±\u20094.12\xa0cm', 'elderly women']","['high vs moderate-intensity intermittent training', 'training and detraining periods of high-intensity interval training (HIIT), moderate-intensity interval training (MIIT) and moderate-intensity continuous training (MICT', 'treadmill exercise twice-weekly HIIT', 'MICT']","['body mass', 'fat mass', 'resting heart rate', 'functionality, resting heart rate and blood pressure', 'body composition and functional performance', 'functional performance, body composition, resting blood pressure and heart rate']","[{'cui': 'C0524338', 'cui_str': 'Elderly woman (person)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517790', 'cui_str': '5.2 (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}]","[{'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate (observable entity)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C3853978'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",46.0,0.0294293,HIIT promoted greater benefits for body composition and functional performance than MICT and MIIT and also showed less pronounced effects of detraining.,"[{'ForeName': 'Victor Silveira', 'Initials': 'VS', 'LastName': 'Coswig', 'Affiliation': 'College of Physical Education, Federal University of Pará, Castanhal, Pará, Brazil.'}, {'ForeName': 'Matheus', 'Initials': 'M', 'LastName': 'Barbalho', 'Affiliation': 'College of Physical Education and Dance, Federal University of Goiás, Goiânia, Brazil. matheussmbarbalho@gmail.com.'}, {'ForeName': 'Rodolfo', 'Initials': 'R', 'LastName': 'Raiol', 'Affiliation': 'Center for Biological and Health Sciences, University Center of the State of Pará, Belém, Pará, Brazil.'}, {'ForeName': 'Fabrício Boscolo', 'Initials': 'FB', 'LastName': 'Del Vecchio', 'Affiliation': 'Superior School of Physical Education, Federal University of Pelotas, Pelotas, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Ramirez-Campillo', 'Affiliation': 'Department of Physical Activity Sciences, Research Nucleus in Health Physical Activity, and Sport, Laboratory of Measurement and Assessment in Sport, Universidad de Los Lagos, Osorno, Chile.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Gentil', 'Affiliation': 'College of Physical Education and Dance, Federal University of Goiás, Goiânia, Brazil.'}]",Journal of translational medicine,['10.1186/s12967-020-02261-8']
3324,32092190,"Randomized, Controlled Trial of Exercise on Objective and Subjective Sleep in Parkinson's Disease.","BACKGROUND


Sleep dysfunction is common and disabling in persons with Parkinson's Disease (PD). Exercise improves motor symptoms and subjective sleep quality in PD, but there are no published studies evaluating the impact of exercise on objective sleep outcomes. The goal of this study was to to determine if high-intensity exercise rehabilitation combining resistance training and body-weight interval training, compared with a sleep hygiene control improved objective sleep outcomes in PD.
METHODS


Persons with PD (Hoehn & Yahr stages 2-3; aged ≥45 years, not in a regular exercise program) were randomized to exercise (supervised 3 times a week for 16 weeks; n = 27) or a sleep hygiene, no-exercise control (in-person discussion and monthly phone calls; n = 28). Participants underwent polysomnography at baseline and post-intervention. Change in sleep efficiency was the primary outcome, measured from baseline to post-intervention. Intervention effects were evaluated with general linear models with measurement of group × time interaction. As secondary outcomes, we evaluated changes in other aspects of sleep architecture and compared the effects of acute and chronic training on objective sleep outcomes.
RESULTS


The exercise group showed significant improvement in sleep efficiency compared with the sleep hygiene group (group × time interaction: F = 16.0, P < 0.001, d = 1.08). Other parameters of sleep architecture also improved in exercise compared with sleep hygiene, including total sleep time, wake after sleep onset, and slow-wave sleep. Chronic but not acute exercise improved sleep efficiency compared with baseline.
CONCLUSIONS


High-intensity exercise rehabilitation improves objective sleep outcomes in PD. Exercise is an effective nonpharmacological intervention to improve this disabling nonmotor symptom in PD. © 2020 International Parkinson and Movement Disorder Society.",2020,"Other parameters of sleep architecture also improved in exercise compared with sleep hygiene, including total sleep time, wake after sleep onset, and slow-wave sleep.","['Persons with PD (Hoehn & Yahr stages 2-3; aged ≥45\u2009years, not in a regular exercise program', ""Parkinson's Disease"", 'PD', ""persons with Parkinson's Disease (PD""]","['Exercise', 'High-intensity exercise rehabilitation', 'sleep hygiene, no-exercise control', 'high-intensity exercise rehabilitation combining resistance training and body-weight interval training']","['total sleep time, wake after sleep onset, and slow-wave sleep', 'Objective and Subjective Sleep', 'sleep efficiency', 'motor symptoms and subjective sleep quality', 'objective sleep outcomes']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise (observable entity)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C4277672', 'cui_str': 'Sleep Hygiene'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0234451', 'cui_str': 'Sleep, Slow-Wave'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",,0.070578,"Other parameters of sleep architecture also improved in exercise compared with sleep hygiene, including total sleep time, wake after sleep onset, and slow-wave sleep.","[{'ForeName': 'Amy W', 'Initials': 'AW', 'LastName': 'Amara', 'Affiliation': 'Department of Neurology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Kimberly H', 'Initials': 'KH', 'LastName': 'Wood', 'Affiliation': 'Department of Neurology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Joop', 'Affiliation': 'Department of Neurology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Raima A', 'Initials': 'RA', 'LastName': 'Memon', 'Affiliation': 'Department of Neurology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Pilkington', 'Affiliation': 'Department of Neurology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'S Craig', 'Initials': 'SC', 'LastName': 'Tuggle', 'Affiliation': 'UAB Center for Exercise Medicine. Birmingham, Alabama, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Reams', 'Affiliation': 'UAB Center for Exercise Medicine. Birmingham, Alabama, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Barrett', 'Affiliation': 'Department of Neurology, University of Virginia, Charlottesville, Virginia, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Edwards', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, Virginia, USA.'}, {'ForeName': 'Arthur L', 'Initials': 'AL', 'LastName': 'Weltman', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, Virginia, USA.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Hurt', 'Affiliation': 'UAB Center for Exercise Medicine. Birmingham, Alabama, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Cutter', 'Affiliation': 'UAB Center for Exercise Medicine. Birmingham, Alabama, USA.'}, {'ForeName': 'Marcas M', 'Initials': 'MM', 'LastName': 'Bamman', 'Affiliation': 'Department of Neurology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.28009']
3325,32056537,Sleep intervention for children with asthma and their parents (SKIP Study): a novel web-based shared management pilot study.,"STUDY OBJECTIVES


The objective of this study was to describe the feasibility, acceptability, and preliminary efficacy of a novel Sleep Intervention for Kids and Parents (SKIP). Parent and child primary sleep outcomes were total sleep time, wake after sleep onset (WASO), sleep efficiency (SE), and bedtime range.
METHODS


Children 6-11 years of age with asthma and 1 parent, both with behavioral sleep disturbance, enrolled in this single-group pilot. The 8-week shared management intervention included weekly online educational modules, goal setting, and progress reporting. Feasibility was measured by the number of dyads who were eligible, enrolled, and retained. Acceptability was measured by survey and semistructured interview. Total sleep time, WASO, SE, and bedtime range were measured by actigraphy at baseline, after the intervention, and 12-week follow-up. Mixed-effects regression models were used to determine change in sleep outcomes from baseline.
RESULTS


Thirty-three of 39 eligible dyads enrolled; of 29 dyads that started the intervention, 25 (86%) completed all study visits. SKIP was acceptable for 61% of children and 92% of parents. Compared with baseline, at follow-up, children had significantly improved WASO (-37 minutes; 95% confidence interval [CI], -44.5 to -29.7; P < .001), SE (5.4%; 95% CI, 4.2-6.5; P < .001), and bedtime range (-35.2 minutes; 95% CI, -42.9 to -27.5; P < .001). Parents also had significantly improved WASO (-13.9 minutes; 95% CI, -19.5 to -8.2; P < .001), SE (2.7%; 95% CI, 1.7-.7; P < .001), and bedtime range (-35.3 minutes; 95% CI, -51.0 to -19.7; P < .001).
CONCLUSIONS


SKIP was feasible, acceptable, and we observed improved child and parent sleep outcomes except total sleep time. Following refinements, further testing of SKIP in a controlled clinical trial is warranted. Clinical Trial Registration: Registry: ClinicalTrials.gov; Name: Sleep Intervention for Kids and Parents: A Self-Management Pilot Study; URL: https://www.clinicaltrials.gov/ct2/show/study/NCT03144531; Identifier: NCT03144531.",2020,"Parents also had significantly improved WASO (-13.9 min [-19.5 to -8.2], p<.001), SE (2.7% [1.7 to 3.7], p<.001), and bedtime range (-35.3 min [-51.0 to -19.7], p<.001).
","['Thirty-three out of 39 eligible dyads enrolled; of 29 dyads that started the intervention, 25 (86%) completed all study visits', 'Children aged 6-11 years with asthma and one parent, both with behavioral sleep disturbance, enrolled in this single-group pilot', 'Kids and Parents (SKIP', 'Children with Asthma and their Parents (SKIP']","['Sleep Intervention', 'novel Sleep Intervention']","['Acceptability', 'WASO', 'total sleep time (TST), wake after sleep onset (WASO), sleep efficiency (SE), and bedtime range', 'TST, WASO, SE and bedtime range']","[{'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C0560435', 'cui_str': 'Does skip (finding)'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0521112', 'cui_str': 'Bedtime (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]",39.0,0.0932582,"Parents also had significantly improved WASO (-13.9 min [-19.5 to -8.2], p<.001), SE (2.7% [1.7 to 3.7], p<.001), and bedtime range (-35.3 min [-51.0 to -19.7], p<.001).
","[{'ForeName': 'Jennifer T', 'Initials': 'JT', 'LastName': 'Sonney', 'Affiliation': 'Department of Child, Family, and Population Health Nursing, University of Washington School of Nursing, Seattle, Washington.'}, {'ForeName': 'Hilaire J', 'Initials': 'HJ', 'LastName': 'Thompson', 'Affiliation': 'Department of Biobehavioral Nursing and Health Informatics, University of Washington School of Nursing, Seattle, Washington.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Landis', 'Affiliation': 'Department of Biobehavioral Nursing and Health Informatics, University of Washington School of Nursing, Seattle, Washington.'}, {'ForeName': 'Kenneth C', 'Initials': 'KC', 'LastName': 'Pike', 'Affiliation': 'Office of Nursing Research, University of Washington School of Nursing, Seattle, Washington.'}, {'ForeName': 'Maida L', 'Initials': 'ML', 'LastName': 'Chen', 'Affiliation': ""Pulmonary and Sleep Medicine, Seattle Children's Hospital, Seattle, Washington.""}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Garrison', 'Affiliation': 'Department of Health Services, University of Washington School of Public Health, Division of Child and Adolescent Psychiatry, University of Washington School of Medicine, Seattle, Washington.'}, {'ForeName': 'Teresa M', 'Initials': 'TM', 'LastName': 'Ward', 'Affiliation': 'Department of Child, Family, and Population Health Nursing, University of Washington School of Nursing, Seattle, Washington.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8374']
3326,31727428,Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 3 Years of Follow-up.,"PURPOSE


To report 3-year results of the Primary Tube Versus Trabeculectomy (PTVT) Study.
DESIGN


Unmasked multicenter randomized clinical trial.
PARTICIPANTS


Two hundred forty-two eyes of 242 patients with medically uncontrolled glaucoma and no previous incisional ocular surgery, including 125 in the tube group and 117 in the trabeculectomy group.
METHODS


Patients were enrolled at 16 clinical centers and were assigned randomly to treatment with a tube shunt (350-mm 2  Baerveldt glaucoma implant) or trabeculectomy with mitomycin C (MMC; 0.4 mg/ml for 2 minutes).
MAIN OUTCOME MEASURES


The primary outcome measure was the rate of surgical failure, defined as intraocular pressure (IOP) of more than 21 mmHg or reduced less than 20% from baseline, IOP of 5 mmHg or less, reoperation for glaucoma, or loss of light perception vision. Secondary outcome measures included IOP, glaucoma medical therapy, visual acuity, and surgical complications.
RESULTS


The cumulative probability of failure after 3 years of follow-up was 33% in the tube group and 28% in the trabeculectomy group (P = 0.17; hazard ratio, 1.39; 95% confidence interval, 0.9-2.2). Mean ± standard deviation IOP was 14.0±4.2 mmHg in the tube group and 12.1±4.8 mmHg in the trabeculectomy group at 3 years (P = 0.008), and the number of glaucoma medications was 2.1±1.4 in the tube group and 1.2±1.5 in the trabeculectomy group (P < 0.001). Serious complications requiring reoperation or producing loss of 2 or more Snellen lines developed in 3 patients (2%) in the tube group and 9 patients (8%) in the trabeculectomy group (P = 0.11).
CONCLUSIONS


There was no significant difference in the rate of surgical failure between the 2 surgical procedures at 3 years. Trabeculectomy with MMC achieved lower IOP with use of fewer glaucoma medications compared with tube shunt surgery after 3 years of follow-up in the PTVT Study. Serious complications producing vision loss or requiring reoperation occurred with similar frequency after both surgical procedures.",2020,Trabeculectomy with MMC achieved lower IOP with use of fewer glaucoma medications compared with tube shunt surgery after 3 years of follow-up in the PTVT Study.,"['Patients were enrolled at 16 clinical centers', 'Two hundred forty-two eyes of 242 patients with medically uncontrolled glaucoma and no previous incisional ocular surgery, including 125 in the tube group and 117 in the trabeculectomy group']","['tube shunt surgery', 'tube shunt (350-mm 2  Baerveldt glaucoma implant) or trabeculectomy with mitomycin C (MMC; 0.4 mg/ml for 2 minutes', 'Trabeculectomy with MMC', 'Primary Tube Versus Trabeculectomy (PTVT']","['Serious complications requiring reoperation or producing loss of 2 or more Snellen lines', 'Mean ± standard deviation IOP', 'cumulative probability of failure', 'rate of surgical failure', 'number of glaucoma medications', 'rate of surgical failure, defined as intraocular pressure (IOP) of more than 21 mmHg or reduced less than 20% from baseline, IOP of 5 mmHg or less, reoperation for glaucoma, or loss of light perception vision', 'IOP, glaucoma medical therapy, visual acuity, and surgical complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1705869', 'cui_str': 'Ophthalmic surgery (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0303409', 'cui_str': '117-In'}, {'cui': 'C3263686', 'cui_str': 'Ocular trabeculectomy'}]","[{'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C1442858', 'cui_str': 'Surgical fistula'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C3263686', 'cui_str': 'Ocular trabeculectomy'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1868733', 'cui_str': 'Surgical failure'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]",242.0,0.165416,Trabeculectomy with MMC achieved lower IOP with use of fewer glaucoma medications compared with tube shunt surgery after 3 years of follow-up in the PTVT Study.,"[{'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Gedde', 'Affiliation': 'Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida. Electronic address: sgedde@med.miami.edu.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Feuer', 'Affiliation': 'Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Kin Sheng', 'Initials': 'KS', 'LastName': 'Lim', 'Affiliation': 'St. Thomas Hospital, London, United Kingdom.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Barton', 'Affiliation': 'Moorfields Eye Hospital, London, United Kingdom.'}, {'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Goyal', 'Affiliation': ""Queen Mary's Hospital, Sidcup, United Kingdom.""}, {'ForeName': 'Iqbal I K', 'Initials': 'IIK', 'LastName': 'Ahmed', 'Affiliation': 'University of Toronto, Toronto, Canada.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Brandt', 'Affiliation': 'Department of Ophthalmology, University of California, Davis, Sacramento, California.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2019.10.002']
3327,31743136,Electrocardiographic Effects of Propofol versus Etomidate in Patients with Brugada Syndrome.,"BACKGROUND


Brugada Syndrome is an inherited arrhythmogenic disease, characterized by the typical coved type ST-segment elevation in the right precordial leads from V1 through V3. The BrugadaDrugs.org Advisory Board recommends avoiding administration of propofol in patients with Brugada Syndrome. Since prospective studies are lacking, it was the purpose of this study to assess the electrocardiographic effects of propofol and etomidate on the ST- and QRS-segments. In this trial, it was hypothesized that administration of propofol or etomidate in bolus for induction of anesthesia, in patients with Brugada Syndrome, do not clinically affect the ST- and QRS-segments and do not induce arrhythmias.
METHODS


In this prospective, double-blinded trial, 98 patients with established Brugada syndrome were randomized to receive propofol (2 to 3 mg/kg) or etomidate (0.2 to 0.3 mg/kg) for induction of anesthesia. The primary endpoints were the changes of the ST- and QRS-segment, and the occurrence of new arrhythmias upon induction of anesthesia.
RESULTS


The analysis included 80 patients: 43 were administered propofol and 37 etomidate. None of the patients had a ST elevation greater than or equal to 0.2 mV, one in each group had a ST elevation of 0.15 mV. An ST depression up to -0.15mV was observed eleven times with propofol and five with etomidate. A QRS-prolongation of 25% upon induction was seen in one patient with propofol and three with etomidate. This trial failed to establish any evidence to suggest that changes in either group differed, with most percentiles being zero (median [25th, 75th], 0 [0, 0] vs. 0 [0, 0]). Finally, no new arrhythmias occurred perioperatively in both groups.
CONCLUSIONS


In this trial, there does not appear to be a significant difference in electrocardiographic changes in patients with Brugada syndrome when propofol versus etomidate were administered for induction of anesthesia. This study did not investigate electrocardiographic changes related to propofol used as an infusion for maintenance of anesthesia, so future studies would be warranted before conclusions about safety of propofol infusions in patients with Brugada syndrome can be determined.",2020,"The primary endpoints were the changes of the ST- and QRS-segment, and the occurrence of new arrhythmias upon induction of anesthesia.
","['patients with Brugada syndrome', '98 patients with established Brugada syndrome', '80 patients: 43 were administered', 'Patients with Brugada Syndrome', 'n = 43) versus', 'n = 37) for induction of general anesthesia', 'patients with Brugada Syndrome']","['propofol and etomidate', 'etomidate', 'propofol and 37 etomidate', 'propofol or etomidate', 'Etomidate', 'propofol', 'propofol versus etomidate', 'Propofol']","['electrocardiographic changes', 'changes of the ST- and QRS-segment, and the occurrence of new arrhythmias upon induction of anesthesia', 'ST depression', 'electrocardiographic effects', 'Electrocardiographic Effects', 'ST elevation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1142166', 'cui_str': 'Sudden Unexplained Death Syndrome'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia (procedure)'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0015131', 'cui_str': 'Etomidate'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0853212', 'cui_str': 'Induction of anesthesia'}, {'cui': 'C0520887', 'cui_str': 'ST segment depression (finding)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation (finding)'}]",98.0,0.0321962,"The primary endpoints were the changes of the ST- and QRS-segment, and the occurrence of new arrhythmias upon induction of anesthesia.
","[{'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Flamée', 'Affiliation': 'From the Department of Anesthesiology and Perioperative Medicine (P.F., H.C., J.T.B., S.B., V.U., C.V., P.F., J.P.) the Heart Rhythm Management Center, Center of Heart and Vascular Disease (V.V., W.D., G-B.,C., P.B., C.d.A.), University Hospital Brussels the Interfaculty Center Data processing & Statistics (W.C.), Free University Brussels, Laarbeeklaan, Brussels, Belgium.'}, {'ForeName': 'Varnavas', 'Initials': 'V', 'LastName': 'Varnavas', 'Affiliation': ''}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Dewals', 'Affiliation': ''}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Carvalho', 'Affiliation': ''}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'Cools', 'Affiliation': ''}, {'ForeName': 'Jigme Tshering', 'Initials': 'JT', 'LastName': 'Bhutia', 'Affiliation': ''}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Beckers', 'Affiliation': ''}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Umbrain', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Verborgh', 'Affiliation': ''}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Forget', 'Affiliation': ''}, {'ForeName': 'Gian-Battista', 'Initials': 'GB', 'LastName': 'Chierchia', 'Affiliation': ''}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Brugada', 'Affiliation': ''}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Poelaert', 'Affiliation': ''}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'de Asmundis', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003030']
3328,31379213,The effect of tea tree oil on dry eye treatment after phacoemulsification cataract surgery: A randomized clinical trial.,"PURPOSE


To evaluate the effect of eyelid scrubbing with eye shampoo containing tea tree oil on dry eye disease following phacoemulsification cataract surgery.
METHODS


This prospective triple-blinded randomized clinical trial was performed on 62 eyes of 62 patients. Patients were randomly assigned to two groups-(1) treatment group: for 33 patients in the treatment group, artificial tears, topical steroid drops, and eye shampoos with tea tree oil and (2) for 29 patients in the control group, artificial tears, topical steroids, and eye shampoos without tea tree oil were used. In the first and second (after 1 month) follow-up visits, microscopic  Demodex  examination, refraction, corrected distance visual acuity, the ocular surface disease index score (by the questionnaire), Schirmer test, tear break-up time test, and osmolarity of tears (by TearLab) were recorded in treatment and control groups.
RESULTS


The mean age of patients was 66.37 ± 8.83 (range: 37-82) years, of which 49 (79%) were female and 13 (21%) were male. The results showed a significant improvement in tear break-up time test, corrected distance visual acuity, osmolarity, and ocular surface disease index score in both groups ( p  < 0.05). However, the number of  Demodex  decreases significantly only in the treatment group after treatment ( p  <0.001). Tear break-up time, osmolarity, and ocular surface disease index scores in the treatment group were significantly better than the control group ( p  < 0.05). However, there was no significant difference between the two groups in the pre- and post-Schirmer test results ( p  > 0.05).
CONCLUSION


Eyelid scrubbing with eye shampoo containing tea tree oil is recommended for dry eye treatment after cataract surgery, especially decrease in the number of  Demodex .",2019,"Tear break-up time, osmolarity, and ocular surface disease index scores in the treatment group were significantly better than the control group ( p  < 0.05).","['dry eye treatment after phacoemulsification cataract surgery', '62 eyes of 62 patients', 'The mean age of patients was 66.37\u2009±\u20098.83 (range: 37-82) years, of which 49 (79%) were female and 13 (21%) were male']","['eyelid scrubbing with eye shampoo containing tea tree oil', 'tea tree oil', 'artificial tears, topical steroid drops, and eye shampoos with tea tree oil and (2) for 29 patients in the control group, artificial tears, topical steroids, and eye shampoos without tea tree oil']","['microscopic  Demodex  examination, refraction, corrected distance visual acuity, the ocular surface disease index score (by the questionnaire), Schirmer test, tear break-up time test, and osmolarity of tears (by TearLab', 'tear break-up time test, corrected distance visual acuity, osmolarity, and ocular surface disease index score', 'number of  Demodex ', 'number of  Demodex  decreases', 'Tear break-up time, osmolarity, and ocular surface disease index scores']","[{'cui': 'C0314719', 'cui_str': 'Dry eyes (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0015426', 'cui_str': 'Eyelids'}, {'cui': 'C2946035', 'cui_str': 'Scrubs'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C1554936', 'cui_str': 'Shampoo - dosing instruction imperative'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0216194', 'cui_str': 'Tea Tree Oil'}, {'cui': 'C2608262', 'cui_str': 'Lubricating Eye Drops'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205288', 'cui_str': 'Microscopic (qualifier value)'}, {'cui': 'C0323683', 'cui_str': 'Demodex (organism)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0430943', 'cui_str': 'Refraction'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test (procedure)""}, {'cui': 'C3665774', 'cui_str': 'Tear break up time test'}, {'cui': 'C0029387', 'cui_str': 'Osmolarity'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0292142,"Tear break-up time, osmolarity, and ocular surface disease index scores in the treatment group were significantly better than the control group ( p  < 0.05).","[{'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Mohammadpour', 'Affiliation': 'Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Siamak', 'Initials': 'S', 'LastName': 'Maleki', 'Affiliation': 'Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Khorrami-Nejad', 'Affiliation': 'Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}]",European journal of ophthalmology,['10.1177/1120672119867642']
3329,32054507,Tianzhi granule improves cognition and BPSD of vascular dementia: a randomized controlled trial.,"BACKGROUND AND PURPOSE


Tianzhi granule (TZ) is usually used for patients with vascular dementia (VaD) in China. The aim was to assess the effect of TZ by a randomized clinical trial (RCT).
METHODS


A 24-week RCT was conducted in 16 centres. Participants were grouped into TZ, donepezil or placebo. The co-primary outcomes were the Vascular Dementia Assessment Scale-cognitive subscale (VADAS-cog) and Clinician's Interview-based Impression of Change-plus caregiver information (CIBIC-plus).
RESULTS


A total of 543 patients with mild to moderate VaD were enrolled, of whom 242 took TZ granules, 241 took donepezil, and 60 took placebo. The least-squares mean changes from baseline and 95% CI were 6.20 (5.31, 7.09) (TZ group), 6.53 (5.63, 7.42) (donepezil group) and 3.47 (1.76, 5.19) (placebo group), both TZ and donepezil showed small but significantly improvement compared with placebo group. The percent of improvement on the global impression which was measured by CIBIC-plus was 73.71% in TZ and 58.18% in placebo, there was significant different between TZ and placebo group (P = 0.004). No significant differences were observed between TZ and donepezil. No significant differences of adverse events were found.
CONCLUSIONS


TZ and donepezil could bring symptomatic benefit for mild to moderate VaD. Trial registration The protocol had retrospectively registered at clinical trial.gov, Unique identifier: NCT02453932, date of registration: May 27, 2015; https://www.clinicaltrials.gov/ct2/show/NCT02453932?term=NCT02453932&rank=1.",2020,"The percent of improvement on the global impression which was measured by CIBIC-plus was 73.71% in TZ and 58.18% in placebo, there was significant different between TZ and placebo group (P = 0.004).","['patients with vascular dementia (VaD) in China', '543 patients with mild to moderate VaD were enrolled, of whom 242 took TZ granules, 241 took donepezil, and 60 took', '16 centres']","['TZ', 'donepezil', 'placebo', 'TZ, donepezil or placebo', 'Tianzhi granule (TZ', 'TZ and donepezil', 'Tianzhi granule', 'TZ and placebo']","[""Vascular Dementia Assessment Scale-cognitive subscale (VADAS-cog) and Clinician's Interview-based Impression of Change-plus caregiver information (CIBIC-plus"", 'cognition and BPSD of vascular dementia', 'global impression', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011269', 'cui_str': 'Dementia, Vascular'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C3853573', 'cui_str': 'Granules'}, {'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3853573', 'cui_str': 'Granules'}]","[{'cui': 'C0011269', 'cui_str': 'Dementia, Vascular'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1868717', 'cui_str': 'BPSD'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",543.0,0.743368,"The percent of improvement on the global impression which was measured by CIBIC-plus was 73.71% in TZ and 58.18% in placebo, there was significant different between TZ and placebo group (P = 0.004).","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Neurology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100007, China.'}, {'ForeName': 'Mingqing', 'Initials': 'M', 'LastName': 'Wei', 'Affiliation': 'Department of Neurology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100007, China.'}, {'ForeName': 'Jingnian', 'Initials': 'J', 'LastName': 'Ni', 'Affiliation': 'Department of Neurology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100007, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': 'Zhongjing Wanxi Pharmaceutical Co., Ltd., Nanyang, 474550, Henan Province, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Department of Neurology, First Hospital of Jilin University, Changchun, 130031, Jilin Province, China.'}, {'ForeName': 'Junfu', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture, Kaifeng Hospital of Traditional Chinese Medicine, Kaifeng, 475000, Henan Province, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': 'Department of Acupuncture, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, First Affiliated Hospital of Anhui Medical University, Hefei, 230022, Anhui Province, China.'}, {'ForeName': 'Peiyuan', 'Initials': 'P', 'LastName': 'Lv', 'Affiliation': 'Department of Neurology, Hebei General Hospital, Shijiazhuang, 050051, Hebei Province, China.'}, {'ForeName': 'Yunfu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Taihe Hospital, Hubei University of Chinese Medicine, Shiyan, 442000, Hubei Province, China.'}, {'ForeName': 'Yulian', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300250, China.'}, {'ForeName': 'Xuguang', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': ""Department of Neurology, Peking University People's Hospital, Beijing, 100044, China.""}, {'ForeName': 'Xuanzhao', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Department of Neurology, Xinxiang Central Hospital, Xinxiang, 453700, Henan Province, China.'}, {'ForeName': 'Benyan', 'Initials': 'B', 'LastName': 'Luo', 'Affiliation': 'Department of Neurology, First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, 310003, Zhejiang Province, China.'}, {'ForeName': 'Shanping', 'Initials': 'S', 'LastName': 'Mao', 'Affiliation': 'Department of Neurology, Renmin Hospital of Wuhan University, Wuhan, 430072, Hubei Province, China.'}, {'ForeName': 'Baorong', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Second Affiliated Hospital of Zhejiang University, Hangzhou, 310009, Zhejiang Province, China.'}, {'ForeName': 'Xiangyang', 'Initials': 'X', 'LastName': 'Ren', 'Affiliation': 'Department of Neurology, Luoyang Central Hospital Affiliated to Zhengzhou University, Luoyang, 471009, Henan Province, China.'}, {'ForeName': 'Fengchun', 'Initials': 'F', 'LastName': 'Yu', 'Affiliation': 'Department of Neurology, Beijing Haidian Hospital, Beijing, 100080, China.'}, {'ForeName': 'Wenli', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': 'Department of Neurology, Beijing Chao-Yang Hospital Affiliated to Capital Medical University, Beijing, 100020, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Yin', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, Hubei Province, China.'}, {'ForeName': 'Nanjin', 'Initials': 'N', 'LastName': 'Wu', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, Hubei Province, China.'}, {'ForeName': 'Xianfeng', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Zhongjing Wanxi Pharmaceutical Co., Ltd., Nanyang, 474550, Henan Province, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Bi', 'Affiliation': 'Department of Neurology, Beijing Anzhen Hospital, Capital Medical University, Beijing, 100029, China.'}, {'ForeName': 'Yongyan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, 100700, China.'}, {'ForeName': 'Jinzhou', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Department of Neurology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100007, China. jztian@hotmail.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of translational medicine,['10.1186/s12967-020-02232-z']
3330,31356537,Alirocumab in Acute Myocardial Infarction: Results From the Virginia Commonwealth University Alirocumab Response Trial (VCU-AlirocRT).,"Alirocumab improves outcomes in patients with a history of recent acute coronary syndrome, but treatment acutely at the time of myocardial infarction is untested. We present the results of a randomized, placebo-controlled, double-blinded pilot study of alirocumab treatment at the time of non-ST elevation MI (NSTEMI). Twenty patients with type 1 NSTEMI and low-density lipoprotein cholesterol (LDL-C) >70 mg/dL despite high intensity statin therapy were randomized 1:1 to one dose of alirocumab 150 mg subcutaneously or placebo within 24 hours of presentation. LDL-C and inflammatory biomarkers-including C-reactive protein-were obtained at baseline, 72 hours, and 14 days. Median (interquartile range) and number (%) were: age 59 (49, 65) years, 7 (35%) men, 16 (80%) black; baseline characteristics were similar between groups. Alirocumab significantly reduced LDL-C from baseline to 14 days by 64 mg/dL (-96, -47) compared with placebo [+1 mg/dL (-25, +16)] (primary endpoint). There were no significant between-group differences in C-reactive protein changes at any time point (all P > 0.2) or serious adverse events attributable to the study treatment. In conclusion, alirocumab administration at the time of NSTEMI significantly reduced LDL-C levels at 14 days, was safe, and had neutral effects on inflammatory biomarkers. Further studies are warranted to explore the effects on clinical outcomes.",2019,There were no significant between-group differences in CRP changes at any time point (all p>0.2) or serious adverse events attributable to the study treatment.,"['Twenty patients with type 1 NSTEMI and low-density lipoprotein cholesterol (LDL-C', 'Acute Myocardial Infarction', 'patients with a history of recent acute coronary syndrome']","['Alirocumab', 'placebo', 'placebo (+1 mg/dL', 'alirocumab 150 mg subcutaneously or placebo', 'alirocumab']","['CRP changes', 'serious adverse events', 'LDL-C', 'LDL-C levels', 'Median (IQR', 'LDL-C and inflammatory biomarkers - including C-reactive protein (CRP) ']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4255010', 'cui_str': 'Non-ST-Elevation Myocardial Infarction'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}]","[{'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]",,0.520706,There were no significant between-group differences in CRP changes at any time point (all p>0.2) or serious adverse events attributable to the study treatment.,"[{'ForeName': 'Cory R', 'Initials': 'CR', 'LastName': 'Trankle', 'Affiliation': 'Division of Cardiology, VCU Pauley Heart Center, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Wohlford', 'Affiliation': 'Department of Pharmacotherapy and Outcomes Science, School of Pharmacy, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Leo F', 'Initials': 'LF', 'LastName': 'Buckley', 'Affiliation': ""Department of Pharmacy Services, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Kadariya', 'Affiliation': 'Division of Cardiology, VCU Pauley Heart Center, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Krishna', 'Initials': 'K', 'LastName': 'Ravindra', 'Affiliation': 'Division of Cardiology, VCU Pauley Heart Center, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Roshanak', 'Initials': 'R', 'LastName': 'Markley', 'Affiliation': 'Division of Cardiology, VCU Pauley Heart Center, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Tae Shik', 'Initials': 'TS', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, VCU Pauley Heart Center, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Potere', 'Affiliation': 'Division of Cardiology, VCU Pauley Heart Center, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Benjamin W', 'Initials': 'BW', 'LastName': 'Van Tassell', 'Affiliation': 'Department of Pharmacotherapy and Outcomes Science, School of Pharmacy, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Abbate', 'Affiliation': 'Division of Cardiology, VCU Pauley Heart Center, Virginia Commonwealth University, Richmond, VA.'}]",Journal of cardiovascular pharmacology,['10.1097/FJC.0000000000000706']
3331,32078815,"Comparison of shortened mosaic HIV-1 vaccine schedules: a randomised, double-blind, placebo-controlled phase 1 trial (IPCAVD010/HPX1002) and a preclinical study in rhesus monkeys (NHP 17-22).","BACKGROUND


Current efficacy studies of a mosaic HIV-1 prophylactic vaccine require four vaccination visits over one year, which is a complex regimen that could prove challenging for vaccine delivery at the community level, both for recipients and clinics. In this study, we evaluated the safety, tolerability, and immunogenicity of shorter, simpler regimens of trivalent Ad26.Mos.HIV expressing mosaic HIV-1 Env/Gag/Pol antigens combined with aluminium phosphate-adjuvanted clade C gp140 protein.
METHODS


We did this randomised, double-blind, placebo-controlled phase 1 trial (IPCAVD010/HPX1002) at Beth Israel Deaconess Medical Center in Boston, MA, USA. We included healthy, HIV-uninfected participants (aged 18-50 years) who were considered at low risk for HIV infection and had not received any vaccines in the 14 days before study commencement. We randomly assigned participants via a computer-generated randomisation schedule and interactive web response system to one of three study groups (1:1:1) testing different regimens of trivalent Ad26.Mos.HIV (5 × 10 10  viral particles per 0·5 mL) combined with 250 μg adjuvanted clade C gp140 protein. They were then assigned to treatment or placebo subgroups (5:1) within each of the three main groups. Participants and investigators were masked to treatment allocation until the end of the follow-up period. Group 1 received Ad26.Mos.HIV alone at weeks 0 and 12 and Ad26.Mos.HIV plus adjuvanted gp140 at weeks 24 and 48. Group 2 received Ad26.Mos.HIV plus adjuvanted gp140 at weeks 0, 12, and 24. Group 3 received Ad26.Mos.HIV alone at week 0 and Ad26.Mos.HIV plus adjuvanted gp140 at weeks 8 and 24. Participants in the control group received 0·5 mL of 0·9% saline. All study interventions were administered intramuscularly. The primary endpoints were Env-specific binding antibody responses at weeks 28, 52, and 72 and safety and tolerability of the vaccine regimens for 28 days after the injection. All participants who received at least one vaccine dose or placebo were included in the safety analysis; immunogenicity was analysed using the per-protocol population. The IPCAVD010/HPX1002 trial is registered with ClinicalTrials.gov, NCT02685020. We also did a parallel preclinical study in rhesus monkeys to test the protective efficacy of the shortened group 3 regimen.
FINDINGS


Between March 7, 2016, and Aug 19, 2016, we randomly assigned 36 participants to receive at least one dose of study vaccine or placebo, ten to each vaccine group and two to the corresponding placebo group. 30 (83%) participants completed the full study, and six (17%) discontinued it prematurely because of loss to follow-up, withdrawal of consent, investigator decision, and an unrelated death from a motor vehicle accident. The two shortened regimens elicited comparable antibody titres against autologous clade C Env at peak immunity to the longer, 12-month regimen: geometric mean titre (GMT) 41 007 (95% CI 17 959-93 636) for group 2 and 49 243 (29 346-82 630) for group 3 at week 28 compared with 44 590 (19 345-102 781) for group 1 at week 52). Antibody responses remained increased (GMT >5000) in groups 2 and 3 at week 52 but were highest in group 1 at week 72. Antibody-dependent cellular phagocytosis, Env-specific IgG3, tier 1A neutralising activity, and broad cellular immune responses were detected in all groups. All vaccine regimens were well tolerated. Mild-to-moderate pain or tenderness at the injection site was the most commonly reported solicited local adverse event, reported by 28 vaccine recipients (93%) and two placebo recipients (33%). Grade 3 solicited systemic adverse events were reported by eight (27%) vaccine recipients and no placebo recipients; the most commonly reported grade 3 systemic symptoms were fatigue, myalgia, and chills. The shortened group 3 regimen induced comparable peak immune responses in 30 rhesus monkeys as in humans and resulted in an 83% (95% CI 38·7-95, p=0·004 log-rank test) reduction in per-exposure acquisition risk after six intrarectal challenges with SHIV-SF162P3 at week 54, more than 6 months after final vaccination.
INTERPRETATION


Short, 6-month regimens of a mosaic HIV-1 prophylactic vaccine elicited robust HIV-specific immune responses that were similar to responses elicited by a longer, 12-month schedule. Preclinical data showed partial protective efficacy of one of the short vaccine regimens in rhesus monkeys. Further clinical studies are required to test the suitability of the shortened vaccine regimens in humans. Such shortened regimens would be valuable to increase vaccine delivery at the community level, particularly in resource-limited settings.
FUNDING


Ragon Institute (Massachusetts General Hospital, Massachusetts Institute of Technology, and Harvard University; Cambridge, MA, USA) and Janssen Vaccines & Prevention (Leiden, Netherlands).",2020,Antibody responses remained increased (GMT >5000) in groups 2 and 3 at week 52 but were highest in group 1 at week 72.,"['HIV (5', 'rhesus monkeys (NHP 17-22', 'All participants who received at least one vaccine dose or', 'healthy, HIV-uninfected participants (aged 18-50 years) who were considered at low risk for HIV infection and had not received any vaccines in the 14 days before study commencement', 'HIV expressing mosaic HIV-1', 'Between March 7, 2016, and Aug 19, 2016, we randomly assigned 36 participants to receive at least one dose of study', 'rhesus monkeys']","['placebo', '0·5 mL of 0·9% saline', 'aluminium phosphate-adjuvanted clade C gp140 protein', 'vaccine or placebo']","['Antibody-dependent cellular phagocytosis, Env-specific IgG3, tier 1A neutralising activity, and broad cellular immune responses', 'Mild-to-moderate pain or tenderness', 'tolerated', 'Grade 3 solicited systemic adverse events', 'grade 3 systemic symptoms were fatigue, myalgia, and chills', 'safety, tolerability, and immunogenicity', 'partial protective efficacy', 'Env-specific binding antibody responses', 'peak immune responses', 'safety and tolerability', 'Antibody responses', 'protective efficacy', 'safety analysis; immunogenicity']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439750', 'cui_str': 'Mosaic (qualifier value)'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0051519', 'cui_str': 'aluminium phosphate'}, {'cui': 'C0061830', 'cui_str': 'GP140'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0031308', 'cui_str': 'Phagocytosis'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0020859', 'cui_str': 'IgG3'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1817908', 'cui_str': 'Cellular Immune Response'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0085593', 'cui_str': 'Chills'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",36.0,0.574721,Antibody responses remained increased (GMT >5000) in groups 2 and 3 at week 52 but were highest in group 1 at week 72.,"[{'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Stephenson', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Wegmann', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Tomaka', 'Affiliation': 'Janssen Research & Development, Titusville, NJ, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Walsh', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'C Sabrina', 'Initials': 'CS', 'LastName': 'Tan', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Ludo', 'Initials': 'L', 'LastName': 'Lavreys', 'Affiliation': 'Janssen Research & Development, Titusville, NJ, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Ansel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Diane G', 'Initials': 'DG', 'LastName': 'Kanjilal', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jaegle', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Nkolola', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Peter', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Fogel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Bradshaw', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tyler', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Tatenda', 'Initials': 'T', 'LastName': 'Makoni', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Howe', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Darla', 'Initials': 'D', 'LastName': 'Quijada', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Abishek', 'Initials': 'A', 'LastName': 'Chandrashekar', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Esther A', 'Initials': 'EA', 'LastName': 'Bondzie', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Borducchi', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Yanosick', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Hendriks', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Nijs', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Truyers', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Tolboom', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Roland C', 'Initials': 'RC', 'LastName': 'Zahn', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Seaman', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Galit', 'Initials': 'G', 'LastName': 'Alter', 'Affiliation': 'Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Stieh', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Pau', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Hanneke', 'Initials': 'H', 'LastName': 'Schuitemaker', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Dan H', 'Initials': 'DH', 'LastName': 'Barouch', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA. Electronic address: dbarouch@bidmc.harvard.edu.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30001-1']
3332,31376858,The effect of food price changes on consumer purchases: a randomised experiment.,"BACKGROUND


Most evidence on health-related food taxes and subsidies relies on observational data and effects on single nutrients or foods instead of total diet. The aim of this study was to measure the effect of randomly assigned food price variations on consumer purchasing, where sets of prices emulated commonly discussed food tax and subsidy policies, including a subsidy on fruit and vegetables, a sweetened beverage tax, and taxes on foods according to sugar, sodium, and saturated fat content.
METHODS


In this study, adult participants (≥18 years) in New Zealand completed up to five weekly shops in a virtual supermarket. Each shopping occasion was randomly allocated to control (no change in prices) or one or more pricing options simulating the following: a fruit and vegetable subsidy (20%), a sweetened beverage tax (20% or 40%), a saturated fat tax (NZ$2 per 100 g or $4 per 100 g saturated fat), a salt tax ($0·02 per 100 mg or $0·04 per 100 mg sodium), or sugar tax ($0·40 per 100 g or $0·80 per 100 g sugar). The primary outcome was the healthiness of the total shopping basket for each weekly shop (% of total unit food items defined as healthy). Low and high price change options were combined in analyses (eg, results for a saturated fat tax are an average of $2 per 100 g or $4 per 100 g).
FINDINGS


Between Feb 1, and Dec 1, 2016, we randomly assigned 1132 shoppers, of whom 1038 (91·7%) completed at least one shop and 743 (71·6%) completed all five shops. Overall, data from 4258 shops were included in the analysis, including 645 control shops, 2545 shops where one policy was activated, and 1068 shops with two (or more) policies activated. In the control condition, 67·90% (SD 13·01) of food purchases were classified as healthy. Three of the five policies increased this proportion by a small, but significant amount (saturated fat tax mean absolute difference 1·77%, 95% CI 1·03 to 2·52, p<0·0001; sugar tax 1·09%, 0·26 to 1·91, p=0·0099; and salt tax 1·31%, 0·50 to 2·13, p=0·0016). The sweetened beverage tax and fruit and vegetable subsidy resulted in non-significant increases of 0·18% (95% CI -0·49 to 0·85, p=0·60) and 0·41% (-0·26 to 1·07, p=0·23), respectively. Both the saturated fat tax and salt tax resulted in the following important substitution effects: an increase in fruit and vegetable purchases as a percentage by weight of all food purchases (saturated fat tax 4·0%, 0·9 to 7·1; salt tax 4·3%, 0·9 to 7·7); but also an increase in sugar as a percentage of total energy (saturated fat tax 5·0%, 2·1 to 7·9; salt tax 3·2%, 0·0 to 6·5). Interaction terms for combined policies were mostly non-significant, consistent with additive effects of policy combinations.
INTERPRETATION


Price changes representing saturated fat, sugar, and salt taxes increased total healthy food purchases. As we observed important substitution effects, a combination of different tax and subsidy policies might be the most effective way to improve diets and decrease diet-related chronic diseases.
FUNDING


Health Research Council of New Zealand.",2019,"The sweetened beverage tax and fruit and vegetable subsidy resulted in non-significant increases of 0·18% (95% CI -0·49 to 0·85, p=0·60) and 0·41% (-0·26 to 1·07, p=0·23), respectively.",['adult participants (≥18 years) in New Zealand completed up to five weekly shops in a virtual supermarket'],"['control (no change in prices) or one or more pricing options simulating the following: a fruit and vegetable subsidy (20%), a sweetened beverage tax (20% or 40%), a saturated fat tax (NZ$2 per 100 g or $4 per 100 g saturated fat), a salt tax ($0·02 per 100 mg or $0·04 per 100 mg sodium), or sugar tax']","['consumer purchases', 'healthiness of the total shopping basket for each weekly shop (% of total unit food items defined as healthy']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0700383', 'cui_str': 'Shop (environment)'}, {'cui': 'C0557778', 'cui_str': 'Supermarket (environment)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0442739', 'cui_str': 'Id status quo'}, {'cui': 'C0080045', 'cui_str': 'Prices'}, {'cui': 'C0033118', 'cui_str': 'Pricing'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0039371', 'cui_str': 'Taxes'}, {'cui': 'C0597423', 'cui_str': 'Fatty Acids, Saturated'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0150768', 'cui_str': 'Shopping (observable entity)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0700383', 'cui_str': 'Shop (environment)'}, {'cui': 'C0439175', 'cui_str': '% of total (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}]",1132.0,0.0671576,"The sweetened beverage tax and fruit and vegetable subsidy resulted in non-significant increases of 0·18% (95% CI -0·49 to 0·85, p=0·60) and 0·41% (-0·26 to 1·07, p=0·23), respectively.","[{'ForeName': 'Wilma E', 'Initials': 'WE', 'LastName': 'Waterlander', 'Affiliation': 'National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand; Department of Public Health, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands. Electronic address: w.waterlander@amsterdamumc.nl.'}, {'ForeName': 'Yannan', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Nhung', 'Initials': 'N', 'LastName': 'Nghiem', 'Affiliation': 'Department of Public Health, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Eyles', 'Affiliation': 'National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Wilson', 'Affiliation': 'Department of Public Health, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Cleghorn', 'Affiliation': 'Department of Public Health, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Genç', 'Affiliation': 'Department of Economics, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Boyd', 'Initials': 'B', 'LastName': 'Swinburn', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Cliona Ni', 'Initials': 'CN', 'LastName': 'Mhurchu', 'Affiliation': 'National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Blakely', 'Affiliation': 'Department of Public Health, University of Otago, Wellington, New Zealand; Melbourne School of Population and Global Health, University of Melbourne, VIC, Australia.'}]",The Lancet. Public health,['10.1016/S2468-2667(19)30105-7']
3333,32059663,Study design of a stepped wedge cluster randomized controlled trial to evaluate the effect of a locally tailored approach for preconception care - the APROPOS-II study.,"BACKGROUND


In a previous feasibility study (APROPOS) in a single municipality of the Netherlands, we showed that a locally tailored preconception care (PCC) approach has the potential to positively affect preconceptional lifestyle behaviours. Therefore, we designed a second study (APROPOS-II) to obtain a more robust body of evidence: a larger group of respondents, more municipalities, randomization, and a more comprehensive set of (clinical) outcomes. The aim of this study is to assess the effectiveness and the implementation process of a local PCC-approach on preconceptional lifestyle behaviours, health outcomes and the reach of PCC among prospective parents and healthcare providers.
METHODS


This study is an effectiveness-implementation hybrid type 2 trial. This involves a stepped-wedge cluster randomized controlled trial design aiming to include over 2000 future parents from six municipalities in the Netherlands. The intervention has a dual-track approach, focusing on both the uptake of PCC among future parents and the provision of PCC by healthcare providers. The PCC-approach consists of 1) a social marketing strategy directed towards prospective parent(s) and 2) a local care pathway to improve interdisciplinary collaboration. Data will be collected before and after the introduction of the intervention through questionnaires and medical records in each of the participating municipalities. The primary outcome of this study is change in lifestyle behaviours (e.g. folic acid use, smoking and alcohol use). Secondary outcomes are pregnancy outcomes (e.g. miscarriage, preterm birth, gestational diabetes) and the uptake of PCC. Moreover, a process evaluation will be performed, providing information on the efficacy, feasibility, barriers and facilitators regarding the implementation of the intervention.
DISCUSSION


The APROPOS-II study introduces a locally tailored PCC-approach in six municipalities in the Netherlands that will contribute to the body of evidence regarding the effectiveness of PCC and its implementation. If this intervention has a positive effect on lifestyle behaviour changes, leading to improved pregnancy outcomes and the future health of prospective parents and their offspring, it could subsequently be upscaled to (inter)national implementation.
TRIAL REGISTRATION


Dutch Trial register: NL7784 (Registered June 6th, 2019).",2020,"If this intervention has a positive effect on lifestyle behaviour changes, leading to improved pregnancy outcomes and the future health of prospective parents and their offspring, it could subsequently be upscaled to (inter)national implementation.
",['2000 future parents from six municipalities in the Netherlands'],['local PCC-approach'],"['lifestyle behaviours (e.g. folic acid use, smoking and alcohol use', 'pregnancy outcomes (e.g. miscarriage, preterm birth, gestational diabetes) and the uptake of PCC']","[{'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0600182'}]","[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0044609', 'cui_str': '1-piperidinocyclohexanecarbonitrile'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0044609', 'cui_str': '1-piperidinocyclohexanecarbonitrile'}]",,0.0713438,"If this intervention has a positive effect on lifestyle behaviour changes, leading to improved pregnancy outcomes and the future health of prospective parents and their offspring, it could subsequently be upscaled to (inter)national implementation.
","[{'ForeName': 'Veronique Y F', 'Initials': 'VYF', 'LastName': 'Maas', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Medical Centre Rotterdam, Rotterdam, Doctor Molewaterplein 40, 3015, GD, the Netherlands.'}, {'ForeName': 'Maria P H', 'Initials': 'MPH', 'LastName': 'Koster', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Medical Centre Rotterdam, Rotterdam, Doctor Molewaterplein 40, 3015, GD, the Netherlands.'}, {'ForeName': 'Erwin', 'Initials': 'E', 'LastName': 'Ista', 'Affiliation': 'Department of Internal Medicine - Nursing Science, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, Doctor Molewaterplein 40, 3015, GD, the Netherlands.'}, {'ForeName': 'Kim L H', 'Initials': 'KLH', 'LastName': 'Vanden Auweele', 'Affiliation': 'HELLP foundation, Zwolle, Postbus 40126, 8004, DC, the Netherlands.'}, {'ForeName': 'Renate W A', 'Initials': 'RWA', 'LastName': 'de Bie', 'Affiliation': 'Department of Obstetrics, Diakonessenhuis hospital, Utrecht, Bosboomstraat 1, 3582, KE, the Netherlands.'}, {'ForeName': 'Denhard J', 'Initials': 'DJ', 'LastName': 'de Smit', 'Affiliation': 'MediClara Projects, Baambrugge, Prinses Beatrixstraat 7, 1396, KD, the Netherlands.'}, {'ForeName': 'Bianca C', 'Initials': 'BC', 'LastName': 'Visser', 'Affiliation': 'Geboorte Concortium Midden Nederland (GCMN), Utrecht, Oudlaan 4, 3515, GA, the Netherlands.'}, {'ForeName': 'Elsbeth H', 'Initials': 'EH', 'LastName': 'van Vliet-Lachotzki', 'Affiliation': 'Dutch Genetic Alliance, VSOP, Utrecht, Koninginnelaan 23, 3762 DA Soest, the Netherlands.'}, {'ForeName': 'Arie', 'Initials': 'A', 'LastName': 'Franx', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Medical Centre Rotterdam, Rotterdam, Doctor Molewaterplein 40, 3015, GD, the Netherlands.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Poels', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Medical Centre Rotterdam, Rotterdam, Doctor Molewaterplein 40, 3015, GD, the Netherlands. info@care2research.com.'}]",BMC public health,['10.1186/s12889-020-8329-1']
3334,32081633,Synthetic coracoclavicular ligament vs. coracoclavicular suspensory construct for treatment of acromioclavicular dislocation: a biomechanical study.,"BACKGROUND


A synthetic ligament (LockDown, Worcestershire, England) has become available to treat complete acromioclavicular dislocation with promising clinical results and potential benefit to avoid postoperative loss of reduction. We investigated the biomechanics of this synthetic ligament in a simulated immediate postoperative rehabilitation setting, hypothesizing that the synthetic ligament would demonstrate less superior coracoclavicular displacement to cyclic loading and higher ultimate load-to-failure values than a coracoclavicular suspensory construct.
METHODS


Seven matched-pair cadaveric shoulders (mean age at time of death, 79 years) were loaded cyclically and to failure. One specimen in each pair was randomly assigned to the synthetic ligament or coracoclavicular suspensory construct. Superiorly directed 70-N cyclic loading for 3000 cycles at 1.0 Hz was applied through the clavicle in a fixed scapula simulating physiologic states during immediate postoperative rehabilitation, followed by a load-to-failure test at 120 mm/min.
RESULTS


After 3000 cycles, the superior displacement of the clavicle in the synthetic ligament (9.2 ± 1.1 mm) was 225% greater than in the coracoclavicular suspensory construct (2.8 ± 0.4 mm, 95% confidence interval [CI] 3.4, 8.3; P < .001). Average stiffness of the synthetic ligament (32.8 N/mm) was 60% lower than that of the coracoclavicular suspensory construct (81.9 N/mm, 95% CI 43.3, 54.9; P < .001). Ultimate load-to-failure of the synthetic ligament was 23% (95% CI 37.9, 301.5; P = .016) lower than the coracoclavicular suspensory construct (580.5 ± 85.1 N and 750.2 ± 135.5 N, respectively).
CONCLUSION


In a simulated immediate postoperative cadaveric model, the synthetic ligament demonstrated poorer biomechanics than the coracoclavicular suspensory construct. These findings suggest that a coracoclavicular suspensory construct may be preferable to a synthetic ligament if early rehabilitation is intended.",2020,"Average stiffness of the synthetic ligament (32.8 N/mm) was 60% lower than that of the coracoclavicular suspensory construct (81.9 N/mm, 95% CI 43.3, 54.9; P < .001).","['Seven matched-pair cadaveric shoulders (mean age at time of death, 79 years', 'acromioclavicular dislocation']","['Synthetic coracoclavicular ligament vs. coracoclavicular suspensory construct', 'synthetic ligament or coracoclavicular suspensory construct']","['Average stiffness of the synthetic ligament', 'superior displacement of the clavicle in the synthetic ligament', 'Ultimate load-to-failure of the synthetic ligament']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1301931', 'cui_str': 'Time of death'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0012691', 'cui_str': 'Joint Dislocations'}]","[{'cui': 'C0225040', 'cui_str': 'Coracoclavicular ligament structure'}, {'cui': 'C0023685', 'cui_str': 'Ligaments'}]","[{'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0023685', 'cui_str': 'Ligaments'}, {'cui': 'C0333045', 'cui_str': 'Superior displacement (morphologic abnormality)'}, {'cui': 'C0008913', 'cui_str': 'Clavicle'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",7.0,0.0761913,"Average stiffness of the synthetic ligament (32.8 N/mm) was 60% lower than that of the coracoclavicular suspensory construct (81.9 N/mm, 95% CI 43.3, 54.9; P < .001).","[{'ForeName': 'Mario H', 'Initials': 'MH', 'LastName': 'Lobao', 'Affiliation': 'Department of Orthopaedic Surgery, MedStar Union Memorial Hospital, Baltimore, MD, USA.'}, {'ForeName': 'R Bruce', 'Initials': 'RB', 'LastName': 'Canham', 'Affiliation': 'Department of Orthopaedic Surgery, MedStar Union Memorial Hospital, Baltimore, MD, USA.'}, {'ForeName': 'Roshan T', 'Initials': 'RT', 'LastName': 'Melvani', 'Affiliation': 'Department of Orthopaedic Surgery, MedStar Union Memorial Hospital, Baltimore, MD, USA.'}, {'ForeName': 'Brent G', 'Initials': 'BG', 'LastName': 'Parks', 'Affiliation': 'Department of Orthopaedic Surgery, MedStar Union Memorial Hospital, Baltimore, MD, USA.'}, {'ForeName': 'Anand M', 'Initials': 'AM', 'LastName': 'Murthi', 'Affiliation': 'Department of Orthopaedic Surgery, MedStar Union Memorial Hospital, Baltimore, MD, USA. Electronic address: lyn.m.jones@medstar.net.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2019.11.017']
3335,31913927,Effects of Low-Dose Ketamine on the Antidepressant Efficacy and Suicidal Ideations in Patients Undergoing Electroconvulsive Therapy.,"OBJECTIVES


It remains controversial whether a subanesthetic dose of ketamine could modulate the antidepressant effect of electroconvulsive therapy (ECT) in patients with major depressive disorder. We investigated the effect of ketamine on accelerating the antidepressant efficacy of ECT.
METHODS


One hundred twenty-seven patients with major depressive disorder were included in this randomized, placebo-controlled, double-blind study. The study group received 0.3 mg/kg ketamine, and the control group received an isovolumetric dose of normal saline before undergoing ECT under propofol anesthesia. The main outcome was the Hamilton Depression Rating Scale score after each ECT session. Suicidal ideation (SI) was also evaluated using the Hamilton Depression Rating Scale. The response, remission, and recurrence rates were analyzed using time-to-event analysis.
RESULTS


No significant differences were found in the overall response, remission, and relapse rates between the groups (P > 0.05). The median number of ECT sessions for achieving response was 4.0 ± 0.41 in the study group and 7.0 ± 0.79 in the control group (P < 0.05). The median number of ECT sessions for achieving remission in the study and control groups was 8.0 ± 0.29 and 9.0 ± 0.48, respectively (P < 0.05). The median number of ECT sessions for achieving SI reduction in the study and control groups was 3.0 ± 0.75 and 6.0 ± 1.19, respectively (P < 0.05).
CONCLUSIONS


Low-dose ketamine (0.3 mg/kg) could modulate the antidepressant efficacy of ECT via accelerating the onset of its effects and reducing the number of ECT sessions required to obtain response, remission, and SI reduction, without influencing the relapse rates in remitting patients after ECT treatment.",2020,"No significant differences were found in the overall response, remission, and relapse rates between the groups (P > 0.05).","['Patients Undergoing Electroconvulsive Therapy', 'One hundred twenty-seven patients with major depressive disorder', 'patients with major depressive disorder']","['placebo', 'ketamine', 'isovolumetric dose of normal saline before undergoing ECT under propofol anesthesia', 'Low-Dose Ketamine', 'electroconvulsive therapy (ECT']","['median number of ECT sessions for achieving remission', 'Hamilton Depression Rating Scale score', 'Hamilton Depression Rating Scale', 'Antidepressant Efficacy and Suicidal Ideations', 'median number of ECT sessions for achieving SI reduction', 'Suicidal ideation (SI', 'overall response, remission, and relapse rates', 'relapse rates', 'response, remission, and SI reduction', 'median number of ECT sessions', 'response, remission, and recurrence rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",127.0,0.115329,"No significant differences were found in the overall response, remission, and relapse rates between the groups (P > 0.05).","[{'ForeName': 'Qibin', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'From the Department of Anesthesiology, The First Affiliated Hospital of Chongqing Medical University, Chongqing.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'From the Department of Anesthesiology, The First Affiliated Hospital of Chongqing Medical University, Chongqing.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'From the Department of Anesthesiology, The First Affiliated Hospital of Chongqing Medical University, Chongqing.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ren', 'Affiliation': 'From the Department of Anesthesiology, The First Affiliated Hospital of Chongqing Medical University, Chongqing.'}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Min', 'Affiliation': 'From the Department of Anesthesiology, The First Affiliated Hospital of Chongqing Medical University, Chongqing.'}, {'ForeName': 'Xuechao', 'Initials': 'X', 'LastName': 'Hao', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, Sichuan.'}, {'ForeName': 'Qinghua', 'Initials': 'Q', 'LastName': 'Luo', 'Affiliation': 'Department of Psychiatry, the First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Jianmei', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, the First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry, the First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}]",The journal of ECT,['10.1097/YCT.0000000000000636']
3336,31794512,"Influence of St. John's Wort on Intravenous Fentanyl Pharmacokinetics, Pharmacodynamics, and Clinical Effects: A Randomized Clinical Trial.","BACKGROUND


Patients often use complementary and alternative herbal medicines, hence, potential exists for adverse herb-drug interactions. Fentanyl is metabolized by hepatic CYP3A4 and considered transported by blood-brain barrier P-glycoprotein. Both disposition processes could be upregulated by the herbal St. John's wort. This investigation evaluated effects of St. John's wort on fixed-dose and apparent steady-state IV fentanyl pharmacokinetics, pharmacodynamics, and clinical effects.
METHODS


Healthy volunteers received a fentanyl fixed-dose infusion and an individually tailored target controlled infusion on separate days, before and after 30-day St. John's wort (300 mg thrice daily; n = 8) or placebo control (n = 8) in a randomized parallel-group design. Fentanyl plasma concentrations, pupil diameter, analgesic response to experimental pain (cold pressor), subjective side effects, and cognitive effects were measured. Plasma fentanyl concentrations and changes in pupil diameter were subjected to pharmacokinetic-pharmacodynamic modeling.
RESULTS


St. John's wort did not alter fentanyl pharmacokinetics. Clearance (l/min) before and after St. John's wort (1.13 ± 0.29 and 1.24 ± 0.26, respectively) or placebo (0.96 ± 0.28 and 1.12 ± 0.27, respectively) were not different. St. John's wort also did not affect fentanyl pharmacodynamics as measured by pupil constriction after fixed-dose and tailored fentanyl infusions. EC50 (ng/ml) was 1.1 ± 0.7 and 1.4 ± 0.9 before and after St. John's wort versus 1.2 ± 0.8 and 1.4 ± 1.7 before and after placebo. Effect site equilibration time, T½,ke0 (min), was 12.8 ± 5.3 and 11.3 ± 6.4 before and after St. John's wort versus 11.4 ± 6.4 and 11.1 ± 5.6 before and after placebo. St. John's wort had no influence on analgesia, cognitive performance, or somatic cognitive-affective effects of fentanyl.
CONCLUSIONS


St. John's wort did not alter fentanyl pharmacokinetics, pharmacodynamics or clinical effects, suggesting no effect on hepatic clearance or blood-brain barrier efflux. Patients taking St. John's wort will likely not respond differently to IV fentanyl for anesthesia or analgesia.",2020,"St. John's wort had no influence on analgesia, cognitive performance, or somatic cognitive-affective effects of fentanyl.
",['Healthy volunteers'],"['Fentanyl', 'placebo', 'fentanyl fixed-dose infusion and an individually tailored target controlled infusion', 'placebo control']","['clinical behavior of fentanyl', 'fentanyl pharmacokinetics', 'Fentanyl plasma concentrations, pupil diameter, analgesic response to experimental pain (cold pressor), subjective side effects, and cognitive effects', 'analgesia, cognitive performance, or somatic cognitive-affective effects', 'Clearance', 'Plasma fentanyl concentrations and changes in pupil diameter', 'hepatic clearance or blood-brain barrier efflux', 'fentanyl pharmacokinetics, pharmacodynamics or clinical effects']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test (procedure)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005854', 'cui_str': 'Hemato-Encephalic Barrier'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}]",,0.080582,"St. John's wort had no influence on analgesia, cognitive performance, or somatic cognitive-affective effects of fentanyl.
","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Loughren', 'Affiliation': 'From the Department of Anesthesia and Operative Services, Madigan Army Medical Center, Tacoma, Washington (M.J.L.) the Department of Anesthesiology, Duke University School of Medicine, Durham, North Carolina (E.D.K) the Department of Pharmaceutics, School of Pharmacy, University of Washington, Seattle, Washington (M.J.L., D.D.S.) the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington (M.C.K.-R., K.S., D.D.S.).'}, {'ForeName': 'Evan D', 'Initials': 'ED', 'LastName': 'Kharasch', 'Affiliation': ''}, {'ForeName': 'Megan C', 'Initials': 'MC', 'LastName': 'Kelton-Rehkopf', 'Affiliation': ''}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Syrjala', 'Affiliation': ''}, {'ForeName': 'Danny D', 'Initials': 'DD', 'LastName': 'Shen', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003065']
3337,31609300,Interval Exercise Lowers Circulating CD105 Extracellular Vesicles in Prediabetes.,"BACKGROUND


Extracellular vesicles (EV) are purported to mediate type 2 diabetes and CVD risk and development. Physical activity and a balanced diet reduce disease risk, but no study has tested the hypothesis that short-term interval (INT) training would reduce EV compared with continuous (CONT) exercise in adults with prediabetes.
METHODS


Eighteen obese adults (age, 63.8 ± 1.5 yr; body mass index, 31.0 ± 1.3 kg·m) were screened for prediabetes using American Diabetes Association criteria (75 g oral glucose tolerance test). Subjects were randomized to INT (n = 10, alternating 3-min intervals at 90% and 50% HRpeak, respectively) or CONT (n = 8, 70% HRpeak) training for 12 supervised sessions over 13 d for 60 min·d. Cardiorespiratory fitness (V˙ O2peak), weight (kg), as well as ad libitum dietary intake were assessed and arterial stiffness (augmentation index via applanation tonometry) was calculated using total AUC during a 75-g oral glucose tolerance test performed 24 h after the last exercise bout. Total EV, platelet EV (CD31/CD41), endothelial EV (CD105; CD31/ CD41), platelet endothelial cell adhesion molecule (PECAM) (CD31), and leukocyte EV (CD45; CD45/CD41) were analyzed via imaging flow cytometry preintervention/postintervention.
RESULTS


The INT exercise increased V˙O2peak (P = 0.04) compared with CONT training. Although training had no effect on platelet or leukocyte EV, INT decreased Annexin V- endothelial EV CD105 compared with CONT (P = 0.04). However, after accounting for dietary sugar intake, the intensity effect was lost (P = 0.18). Increased ad libitum dietary sugar intake after training was linked to elevated AV+ CD105 (r = 0.49, P = 0.06) and AV- CD45 (r = 0.59, P = 0.01). Nonetheless, increased V˙O2peak correlated with decreased AV+ CD105 (r = -0.60, P = 0.01).
CONCLUSIONS


Interval exercise training decreases endothelial-derived EV in adults with prediabetes. Although increased sugar consumption may alter EV after a short-term exercise intervention, fitness modifies EV count.",2020,"RESULTS


INT exercise increased VO2peak (P=0.04) compared to CONT training.","['Prediabetes', 'adults with prediabetes', 'Eighteen obese adults (age']","['INT', 'continuous (CONT) exercise', 'CONT', 'Interval exercise training', 'Interval Exercise']","['AV+ CD105', 'Cardiorespiratory fitness (VO2peak), weight (kg), as well as ad-libitum dietary intake', 'INT exercise increased VO2peak', 'platelet or leukocyte EVs, INT decreased Annexin V- endothelial EV CD105', 'arterial stiffness (augmentation index via applanation tonometry; AIx', 'sugar consumption', 'Total EVs, platelet EVs (CD31/CD41), endothelial EVs (CD105; CD31/ CD41), platelet endothelial cell adhesion molecule (PECAM) (CD31) and leukocyte EVs (CD45; CD45/CD41']","[{'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0059249', 'cui_str': 'Lipocortin-V'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0430862', 'cui_str': 'Applanation tonometry (procedure)'}, {'cui': 'C0999177', 'cui_str': 'Genus Aix (organism)'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0225336', 'cui_str': 'Endothelial Cells'}, {'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}, {'cui': 'C0567416', 'cui_str': 'Molecule (substance)'}]",18.0,0.0166246,"RESULTS


INT exercise increased VO2peak (P=0.04) compared to CONT training.","[{'ForeName': 'Natalie Z M', 'Initials': 'NZM', 'LastName': 'Eichner', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Gilbertson', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Heiston', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Musante', 'Affiliation': 'Division of Endocrinology and Metabolism, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'LA Salvia', 'Affiliation': 'Division of Endocrinology and Metabolism, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Weltman', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Uta', 'Initials': 'U', 'LastName': 'Erdbrugger', 'Affiliation': 'Division of Nephrology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Malin', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002185']
3338,32069068,Driving Pressure-limited Strategy for Patients with Acute Respiratory Distress Syndrome. A Pilot Randomized Clinical Trial.,"Rationale:  Evidence from observational studies suggests that driving pressure is strongly associated with pulmonary injury and mortality, regardless of positive end-expiratory pressure (PEEP) levels, tidal volume, or plateau pressure. Therefore, it is possible that targeting driving pressure may improve the safety of ventilation strategies for patients with acute respiratory distress syndrome (ARDS). However, the clinical effects of a driving pressure-limited strategy for ARDS has not been assessed in randomized controlled trials. Objectives:  To evaluate the feasibility of testing a driving pressure-limited strategy in comparison with a conventional lung-protective ventilation strategy in patients with ARDS and a baseline driving pressure of ≥13 cm H 2 O. Methods:  This was a randomized, controlled, nonblinded trial that included 31 patients with ARDS who were on invasive mechanical ventilation and had a driving pressure of ≥13 cm H 2 O. Patients allocated to the driving pressure-limited strategy were ventilated with volume-controlled or pressure-support ventilation modes, with tidal volume titrated to 4-8 ml/kg of predicted body weight (PBW), aiming at a driving pressure of 10 cm H 2 O, or the lowest possible. Patients in the control group were ventilated according to the ARDSNet (Acute Respiratory Distress Syndrome Network) protocol, using a tidal volume of 6 ml/kg PBW, which was allowed to be set down to 4 ml/kg PBW if the plateau pressure was >30 cm H 2 O. The primary endpoint was the driving pressure on Days 1-3. Results:  Sixteen patients were randomized to the driving pressure-limited group and 15 were randomized to the conventional strategy group. All patients were considered in analyses. Most of the patients had mild ARDS with a mean arterial oxygen tension/fraction of inspired oxygen ratio of 215 (standard deviation [SD] = 95). The baseline driving pressure was 15.0 cm H 2 O (SD = 2.6) in both groups. In comparison with the conventional strategy, driving pressure from the first hour to the third day was 4.6 cm H 2 O lower in the driving pressure-limited group (95% confidence interval [CI], 6.5 to 2.8;  P  < 0.001). From the first hour up to the third day, tidal volume in the driving pressure-limited strategy group was kept lower than in the control group (mean difference [ml/kg of PBW], 1.3; 95% CI, 1.7 to 0.9;  P  < 0.001). We did not find statistically significant differences in the incidence of severe acidosis (pH < 7.10) within 7 days (absolute difference -12.1; 95% CI, -41.5 to -17.3) or any clinical secondary endpoint. Conclusions:  In patients with ARDS, a trial assessing the effects of a driving pressure-limited strategy using very low tidal volumes versus a conventional ventilation strategy on clinical outcomes is feasible.Clinical trial registered with ClinicalTrials.gov (NCT02365038).",2020,"We did not find statistically significant differences in the incidence of severe acidosis (pH<7.10) within seven days (absolute difference, -12.1; 95% CI, -41.5 to -17.3]) or any clinical secondary endpoint.
","['Sixteen patients', 'Thirty-one patients with ARDS on invasive mechanical ventilation with driving pressure of 13 cmH2O or higher', 'acute respiratory distress syndrome (ARDS) patients with baseline driving pressure of 13 cmH2O or higher', 'ARDS patients', 'Patients with Acute Respiratory Distress Syndrome (ARDS']","['conventional lung protective ventilation strategy', 'conventional ventilation strategy', 'Driving Pressure-Limited Strategy', 'driving pressure-limited strategy were ventilated with volume-controlled or pressure support ventilation modes, tidal volume titrated to 4-8 mL/kg of predicted body weight (PBW']","['pulmonary injury and mortality, regardless of positive end-expiratory pressure (PEEP) levels, tidal volume or plateau pressure', 'incidence of severe acidosis', 'Baseline driving pressure']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0439476', 'cui_str': 'cmH2O'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0449972', 'cui_str': 'Volume control (attribute)'}, {'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C0040210', 'cui_str': 'Tidal Volume'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]","[{'cui': 'C0273115', 'cui_str': 'Pulmonary Injury'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C3494516', 'cui_str': 'Positive end expiratory pressure (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0040210', 'cui_str': 'Tidal Volume'}, {'cui': 'C0445176', 'cui_str': 'Plateau pressure (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0001122', 'cui_str': 'Acidosis'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",31.0,0.260551,"We did not find statistically significant differences in the incidence of severe acidosis (pH<7.10) within seven days (absolute difference, -12.1; 95% CI, -41.5 to -17.3]) or any clinical secondary endpoint.
","[{'ForeName': 'Marcelo Luz', 'Initials': 'ML', 'LastName': 'Pereira Romano', 'Affiliation': 'HCor Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Israel Silva', 'Initials': 'IS', 'LastName': 'Maia', 'Affiliation': 'Hospital Nereu Ramos, Florianópolis, Brazil.'}, {'ForeName': 'Ligia Nasi', 'Initials': 'LN', 'LastName': 'Laranjeira', 'Affiliation': 'HCor Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Lucas Petri', 'Initials': 'LP', 'LastName': 'Damiani', 'Affiliation': 'HCor Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Denise de Moraes', 'Initials': 'DM', 'LastName': 'Paisani', 'Affiliation': 'HCor Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Marcos de Carvalho', 'Initials': 'MC', 'LastName': 'Borges', 'Affiliation': 'Unidade de Emergência do Hospital das Clínicas da FMRP-USP, Ribeirão Preto, Brazil.'}, {'ForeName': 'Bruno Guimarães', 'Initials': 'BG', 'LastName': 'Dantas', 'Affiliation': 'Unidade de Emergência do Hospital das Clínicas da FMRP-USP, Ribeirão Preto, Brazil.'}, {'ForeName': 'Eliana Bernadete', 'Initials': 'EB', 'LastName': 'Caser', 'Affiliation': 'Hospital Unimed Vitória, Vitória, Brazil.'}, {'ForeName': 'Josué Almeida', 'Initials': 'JA', 'LastName': 'Victorino', 'Affiliation': 'Hospital Cristo Redentor, Porto Alegre, Brazil.'}, {'ForeName': 'Wilson de Oliveira', 'Initials': 'WO', 'LastName': 'Filho', 'Affiliation': 'Hospital e Pronto-Socorro 28 de Agosto, Manaus, Brazil; and.'}, {'ForeName': 'Marcelo Britto Passos', 'Initials': 'MBP', 'LastName': 'Amato', 'Affiliation': 'Cardio-Pulmonary Department, Pulmonary Division, Heart Institute, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alexandre Biasi', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'HCor Research Institute, São Paulo, Brazil.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201907-506OC']
3339,31636065,"A First-in-Human Trial of GLS4, a Novel Inhibitor of Hepatitis B Virus Capsid Assembly, following Single- and Multiple-Ascending-Oral-Dose Studies with or without Ritonavir in Healthy Adult Volunteers.","GLS4 is a novel inhibitor of the hepatitis B virus (HBV) capsid assembly with inhibitory activities against nucleot(s)ide-resistant HBV strains. This study investigated the pharmacokinetics, safety, and tolerability of GLS4 and the effects of food and ritonavir in healthy adults. GLS4 was administered in a single-ascending-dose study over 1 to 240 mg and multiple-ascending-dose study that ranged from 30 mg once daily to 180 mg three times daily. The drug interaction study included sequential design (day 1 for 120 mg GLS4 alone, day 5 for 100 mg ritonavir alone, followed by 9 days of both drugs) and a placebo control (9 days of both 240 mg GLS4 and 100 mg ritonavir). The results showed that the steady-state trough concentration of multiple dosing of GLS4 alone was significantly lower than the 90% effective concentration of 55.7 ng/ml, even with increasing dosing frequency and dosage. An initial dose of 100 mg ritonavir significantly boosted plasma concentration at 24 h of 120 mg GLS4 from 2.40 to 49.8 ng/ml (geometric mean ratio, 20.7; 90% confidence interval, 17.0 to 25.3), while a milder effect was observed on the area under the curve from 0 to 24 h, with a 7.42-fold increase, and on the maximum concentration, with a 4.82-fold increase. The pharmacokinetics change in GLS4 persisted after 9 days of chronic dosing, with a trough concentration of 182 ng/ml. Both single and multiple doses of GLS4 up to 240 mg with or without ritonavir were well tolerated. These results support the investigation of a novel HBV treatment regimen containing GLS4 with 100 mg ritonavir added solely to enhance GLS4 concentrations in plasma. (This study was registered at the China Platform for Registry and Publicity of Drug Clinical Trials [http://www.chinadrugtrials.org.cn] under numbers CTR20132137 and CTR20150230.).",2019,GLS4 is a novel inhibitor of the hepatitis B virus (HBV) capsid assembly with inhibitory activities against nucleot(s)ide-resistant HBV strains.,"['healthy adults', 'healthy adult volunteers']","['GLS4 and 100 mg ritonavir', 'food and ritonavir', 'ritonavir', 'placebo-control', 'GLS4']","['tolerated', 'pharmacokinetics, safety, and tolerability', 'plasma concentration', 'steady-state trough concentration', 'GLS4 concentrations']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}]",,0.032935,GLS4 is a novel inhibitor of the hepatitis B virus (HBV) capsid assembly with inhibitory activities against nucleot(s)ide-resistant HBV strains.,"[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Zhao', 'Affiliation': 'Department of Pharmacy, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Jia', 'Affiliation': 'Department of Pharmacy, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Infectious Diseases, Center for Liver Disease, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Junyu', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Pharmacy, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Sheng', 'Affiliation': 'Department of Pharmacy, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Luo', 'Affiliation': 'The State Key Laboratory of Anti-Infective Drug Development, HEC R&D Center, Sunshine Lake Pharma Co., Ltd., Dongguan, China.'}, {'ForeName': 'Zhangma', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'The State Key Laboratory of Anti-Infective Drug Development, HEC R&D Center, Sunshine Lake Pharma Co., Ltd., Dongguan, China.'}, {'ForeName': 'Xingan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The State Key Laboratory of Anti-Infective Drug Development, HEC R&D Center, Sunshine Lake Pharma Co., Ltd., Dongguan, China.'}, {'ForeName': 'Qingyun', 'Initials': 'Q', 'LastName': 'Ren', 'Affiliation': 'The State Key Laboratory of Anti-Infective Drug Development, HEC R&D Center, Sunshine Lake Pharma Co., Ltd., Dongguan, China.'}, {'ForeName': 'Yingjun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'The State Key Laboratory of Anti-Infective Drug Development, HEC R&D Center, Sunshine Lake Pharma Co., Ltd., Dongguan, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Pharmacy, Peking University First Hospital, Beijing, China zxyjk@126.com cui.pharm@pkufh.com.'}, {'ForeName': 'Yimin', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Department of Pharmacy, Peking University First Hospital, Beijing, China zxyjk@126.com cui.pharm@pkufh.com.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.01686-19']
3340,32077300,Development of a Wellness Committee Implementation Index for Workplace Health Promotion Programs in Small Businesses.,"PURPOSE


To construct a wellness committee (WC) implementation index and determine whether this index was associated with evidence-based intervention implementation in a workplace health promotion program.
DESIGN


Secondary data analysis of the  HealthLinks  randomized controlled trial.
SETTING


Small businesses assigned to the  HealthLinks  plus WC study arm.
SAMPLE


Small businesses (20-200 employees, n = 23) from 6 low-wage industries in King County, Washington.
MEASURES


Wellness committee implementation index (0%-100%) and evidence-based intervention implementation (0%-100%).
ANALYSIS


We used descriptive and bivariate statistics to describe worksites' organizational characteristics. For the primary analyses, we used generalized estimating equations with robust standard errors to assess the association between WC implementation index and evidence-based intervention implementation over time.
RESULTS


Average WC implementation index scores were 60% at 15 months and 38% at 24 months. Evidence-based intervention scores among worksites with WCs were 27% points higher at 15 months (64% vs 37%,  P  < .001) and 36% points higher at 24 months (55% vs 18%,  P  < .001). Higher WC implementation index scores were positively associated with evidence-based intervention implementation scores over time ( P  < .001).
CONCLUSION


Wellness committees may play an essential role in supporting evidence-based intervention implementation among small businesses. Furthermore, the degree to which these WCs are engaged and have leadership support, a set plan or goals, and multilevel participation may influence evidence-based intervention implementation and maintenance over time.",2020,"Higher WC implementation index scores were positively associated with evidence-based intervention implementation scores over time ( P  < .001).
","['Small Businesses', 'Small businesses assigned to the  HealthLinks  plus WC study arm', 'SAMPLE\n\n\nSmall businesses (20-200 employees, n = 23) from 6 low-wage industries in King County, Washington']",[],"['Average WC implementation index scores', 'Higher WC implementation index scores']","[{'cui': 'C2936313', 'cui_str': 'Microenterprise'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0036064', 'cui_str': 'Wages'}, {'cui': 'C0021267', 'cui_str': 'Industry'}, {'cui': 'C0454792', 'cui_str': 'Offaly (geographic location)'}, {'cui': 'C0043038', 'cui_str': 'Washington'}]",[],"[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",,0.0927082,"Higher WC implementation index scores were positively associated with evidence-based intervention implementation scores over time ( P  < .001).
","[{'ForeName': 'Meagan C', 'Initials': 'MC', 'LastName': 'Brown', 'Affiliation': 'Department of Health Services, School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Harris', 'Affiliation': 'Department of Health Services, School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Hammerback', 'Affiliation': 'Department of Health Services, School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Marlana J', 'Initials': 'MJ', 'LastName': 'Kohn', 'Affiliation': 'Department of Health Services, School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Amanda T', 'Initials': 'AT', 'LastName': 'Parrish', 'Affiliation': 'Department of Health Services, School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Gary K', 'Initials': 'GK', 'LastName': 'Chan', 'Affiliation': 'Department of Health Services, School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'India J', 'Initials': 'IJ', 'LastName': 'Ornelas', 'Affiliation': 'Department of Health Services, School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Christian D', 'Initials': 'CD', 'LastName': 'Helfrich', 'Affiliation': 'Department of Health Services, School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Peggy A', 'Initials': 'PA', 'LastName': 'Hannon', 'Affiliation': 'Department of Health Services, School of Public Health, University of Washington, Seattle, WA, USA.'}]",American journal of health promotion : AJHP,['10.1177/0890117120906967']
3341,31375458,Prediction of maximum oxygen uptake through incremental exercise testing using ventilometry: a cross-sectional study.,"BACKGROUND


Cardiopulmonary exercise testing is the main tool assessing cardiorespiratory fitness. However, cardiopulmonary exercise testing devices are expensive and often cannot be used.
OBJECTIVE


The present study sought to develop cardiopulmonary exercise testing equations for estimating maximum oxygen uptake from ergometric testing combined with ventilometry.
METHODS


181 volunteers of both sexes were submitted to cardiopulmonary exercise testing on treadmill using an incremental protocol. Volunteers were randomized into two groups: regression group: composed of 68 women with age 24.7±6.0 years and 54 men aged 21.5±3.9 years; and a cross-validation group composed of 29 women with mean age of 23.8±4.7 years and 30 men with a mean age of 23.1±4.4 years. The estimating equations were developed using multiple stepwise linear regressions; comparison of means was done using a t test and reliability assessed by Cronbach's alpha.
RESULTS


8 independent variables exhibited a significant result for estimating VO 2max : minute ventilation (E) at second ventilatory threshold (VT-II): (E _VT-II); heart rate at VT-II (HR_VT-II); body mass (BM); body mass index (BMI); fat percentage (F%); age; sex; velocity at VT-II (Vel_VT-II); test time of VT-II (T_VT-II) and final test velocity (Vel final ). Two equations presented more accurate results; for active subjects: Equation 2  = 33.08 + 2.41*(Vel final ) - 0.32*(F%) + 0.40*(VE_VT-II) - 0.26*(BM) - 0.09*(HR_VT-II); for sedentary subjects: Equation 3  for = 54.65 + 1.37*(T_VT-II) + 8.24*(sex) - 1.26*(BMI) + 0.37*(VE_VT-II) - 0.12*(HR_VT-II).
CONCLUSION


The present study demonstrated that the use of parameters collected during maximal ergometric test combined with ventilometry, improved the accuracy of equations for estimating maximum oxygen uptake.",2019,"Two equations presented more accurate results; for active subjects: Equation 2  = 33.08 + 2.41*(Vel final ) - 0.32*(F%) + 0.40*(VE_VT-II) - 0.26*(BM) - 0.09*(HR_VT-II); for sedentary subjects: Equation 3  for = 54.65 + 1.37*(T_VT-II) + 8.24*(sex) - 1.26*(BMI) + 0.37*(VE_VT-II) - 0.12*(HR_VT-II).
","['181 volunteers of both sexes', '68 women with age 24.7±6.0 years end 54 men aged 21.5±3.9 years; and cross-validation group: was composed 29 women with mean age 23.8±4.7 years and 30 men with mean 23.1±4.4 years']","['incremental exercise testing using ventilometry', 'Cardiopulmonary exercise testing on treadmill using an incremental protocol', 'Cardiopulmonary exercise testing equations']",['estimating VO 2max : minute ventilation (E) at second ventilatory threshold (VT-II): (E _VT-II); heart rate at VT-II (HR_VT-II); body mass (BM); body mass index (BMI); fat percentage (F%); age; sex; velocity at VT-II (Vel_VT-II); test time of VT-II (T_VT-II) and final test velocity (Vel final '],"[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0429928', 'cui_str': 'Test time (observable entity)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",181.0,0.0202251,"Two equations presented more accurate results; for active subjects: Equation 2  = 33.08 + 2.41*(Vel final ) - 0.32*(F%) + 0.40*(VE_VT-II) - 0.26*(BM) - 0.09*(HR_VT-II); for sedentary subjects: Equation 3  for = 54.65 + 1.37*(T_VT-II) + 8.24*(sex) - 1.26*(BMI) + 0.37*(VE_VT-II) - 0.12*(HR_VT-II).
","[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Policarpo Barbosa', 'Affiliation': 'Laboratory of Human Movement Biosciences, Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, RJ, Brazil. Electronic address: fernandopolicarpo65@gmail.com.'}, {'ForeName': 'Paulo Eugênio', 'Initials': 'PE', 'LastName': 'Silva', 'Affiliation': 'Post-Graduate Program in Science and Technology in Health, Universidade de Brasília (UnB), Brasília, DF, Brazil.'}, {'ForeName': 'Andréa Carmen', 'Initials': 'AC', 'LastName': 'Guimarães', 'Affiliation': 'Laboratory of Human Movement Biosciences, Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, RJ, Brazil; Department of Physical Education and Health Sciences, Universidade Federal de São João Del-Rei (UFSJ), São João del Rei, MG, Brazil.'}, {'ForeName': 'Carlos Soares', 'Initials': 'CS', 'LastName': 'Pernambuco', 'Affiliation': ""Doctor's Degree Program in Nursing and Biosciences - PPgEnfBio, Federal University of the State of Rio de Janeiro - UNIRIO, Rio de Janeiro, Brazil; Master and Doctor's Degree Program in Health and Environment - PSA, Tiradentes University - UNIT, Aracaju, Brazil.""}, {'ForeName': 'Estélio Henrique', 'Initials': 'EH', 'LastName': 'Dantas', 'Affiliation': ""Doctor's Degree Program in Nursing and Biosciences - PPgEnfBio, Federal University of the State of Rio de Janeiro - UNIRIO, Rio de Janeiro, Brazil; College of Physical Education, Universidade Tiradentes, Aracajú, SE, Brazil.""}]",Brazilian journal of physical therapy,['10.1016/j.bjpt.2019.07.002']
3342,31373696,Response to Glucocorticosteroids Predicts Olfactory Outcome After ESS in Chronic Rhinosinusitis.,"OBJECTIVES


Olfaction is frequently impaired in chronic rhinosinusitis with nasal polyps (CRSwNP) and often improves after endoscopic sinus surgery (ESS). Data about dynamics of olfactory changes after ESS are lacking, and little information is available concerning whether preoperatively administered glucocorticosteroids predict postoperative olfaction. Therefore, the aim of this study was to examine dynamics of olfaction after ESS in relation to the effect of preoperative administration of glucocorticosteroids in CRSwNP.
METHODS


This prospective study included 52 CRSwNP patients (30 men, 22 women, mean age 54 ± 14 years) divided into a control group (n = 31) subjected to ESS without preoperative steroids and a treatment group (n = 21) receiving orally administered glucocorticosteroids preoperatively. Self-ratings of olfaction and olfactory testing using the extended Sniffin' Sticks test battery (threshold, discrimination and identification [TDI] score) were performed. Olfaction was measured preoperatively; after termination of glucocorticosteroid treatment (only treatment group); and 2 weeks, 1 month, and 3 months postoperatively.
RESULTS


After glucocorticosteroids, TDI score significantly improved in 57% of patients, and olfactory function remained unchanged in 43%. In addition, improvement in TDI score after steroids and 3 months postoperatively were significantly correlated (r = 0.66, P = 0.01). Patients whose olfaction did not improve after glucocorticosteroids did not benefit from surgery. Regarding postoperative olfactory dynamics, TDI score reached its maximum 1 month postoperatively and decreased again approximately 3 months after surgery.
CONCLUSION


Glucocorticosteroids improved olfaction in CRSwNP comparable to surgery. In addition, changes in relation to steroids predicted olfactory outcome postoperatively. Regarding the olfactory dynamics, it could be demonstrated that olfactory function increased 1 month after surgery and decreased 3 months postoperatively.
LEVEL OF EVIDENCE


2 Laryngoscope, 130:1616-1621, 2020.",2020,"After glucocorticosteroids, TDI score significantly improved in 57% of patients, and olfactory function remained unchanged in 43%.","['52 CRSwNP patients (30 men, 22 women, mean age 54\u2009±\u200914\u2009years) divided into a control group (n = 31) subjected to', 'Chronic Rhinosinusitis', 'chronic rhinosinusitis with nasal polyps (CRSwNP']","['ESS without preoperative steroids and a treatment group (n = 21) receiving orally administered glucocorticosteroids preoperatively', 'Glucocorticosteroids', 'glucocorticosteroids', 'endoscopic sinus surgery (ESS']","[""extended Sniffin' Sticks test battery (threshold, discrimination and identification [TDI] score"", 'olfactory function', 'TDI score', 'Olfactory Outcome', 'Olfaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0149516', 'cui_str': 'Chronic sinusitis (disorder)'}, {'cui': 'C4524092', 'cui_str': 'Chronic rhinosinusitis with nasal polyps'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C4318418', 'cui_str': 'Stick'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439826', 'cui_str': 'Olfactory (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0037361', 'cui_str': 'Sense of Smell'}]",22.0,0.0370891,"After glucocorticosteroids, TDI score significantly improved in 57% of patients, and olfactory function remained unchanged in 43%.","[{'ForeName': 'Vasyl', 'Initials': 'V', 'LastName': 'Bogdanov', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, Technische Universität Dresden, Dresden.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Walliczek-Dworschak', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, Technische Universität Dresden, Dresden.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Whitcroft', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, Technische Universität Dresden, Dresden.'}, {'ForeName': 'Basile N', 'Initials': 'BN', 'LastName': 'Landis', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, Technische Universität Dresden, Dresden.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hummel', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, Technische Universität Dresden, Dresden.'}]",The Laryngoscope,['10.1002/lary.28233']
3343,31354330,General theory of inflammation: patient self-administration of hydrocortisone safely achieves superior control of hydrocortisone-responding disorders by matching dosage with symptom intensity.,"Objective:  To determine if patient self-administration of hydrocortisone will safely achieve superior symptom control for all hydrocortisone-responding disorders as it does for Addison's disease and rheumatoid arthritis.  Methods:  Two thousand four hundred and twenty-eight participants with hydrocortisone-responding disorders were brought to a minimum symptom state using daily administered hydrocortisone tablets in a 24-week, open study. Thereafter, participants used 5-day, low-dose hydrocortisone regimens to quench subsequent disorder exacerbations (flares) to maintain the minimum symptom state. Stressors such as emotional traumas, infections, allergies, and injuries were minimized to reduce disorder intensity, hydrocortisone consumption, and participant discomfort.  Results:  Two thousand fifteen participants, 601 with fibromyalgia, 579 with osteoarthritis, 246 with rheumatoid arthritis, 226 with undifferentiated arthritis, 75 with back pain, 51 with Parkinson's disease, 44 with polymyalgia rheumatica, 25 with neuropathy, 25 with chronic fatigue syndrome, 25 with dementia, 21 with migraine headache, 19 with multiple sclerosis, and 78 with other disorders completed the 24-week study to achieve a composite average symptom improvement of 76% with equal response rates. The participants averaged ingesting 12 mg of hydrocortisone per day. No significant adverse reactions were observed.  Conclusions:  Patient self-administration of hydrocortisone safely achieves superior symptom control for 38 hydrocortisone-responding disorders at equal rates and symptom improvements to confirm and amplify an earlier double-blind study finding on rheumatoid arthritis. These results are consistent with the body having an inflammation control system and chronic inflammation being a disorder unto itself with differing symptoms sets dependent on its location.  Clinical Trials Government Identifier:  NCT03558971.",2019,No significant adverse reactions were observed.  ,"[""Two thousand fifteen participants, 601 with fibromyalgia, 579 with osteoarthritis, 246 with rheumatoid arthritis, 226 with undifferentiated arthritis, 75 with back pain, 51 with Parkinson's disease, 44 with polymyalgia rheumatica, 25 with neuropathy, 25 with chronic fatigue syndrome, 25 with dementia, 21 with migraine headache, 19 with multiple sclerosis, and 78 with other disorders completed the 24-week study to achieve a composite average symptom improvement of 76% with equal response rates"", 'Two thousand four hundred and twenty-eight participants with hydrocortisone-responding disorders', 'General theory of inflammation']","['hydrocortisone', 'hydrocortisone tablets']","['disorder intensity, hydrocortisone consumption, and participant discomfort', 'adverse reactions']","[{'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0205618', 'cui_str': 'Undifferentiated (qualifier value)'}, {'cui': 'C3666006', 'cui_str': 'Arthritis (SMQ)'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0032533', 'cui_str': 'Forestier-Certonciny Syndrome'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0015674', 'cui_str': 'Systemic Exertion Intolerance Disease'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C4517656', 'cui_str': 'Two thousand four hundred'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]","[{'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}]",2015.0,0.100261,No significant adverse reactions were observed.  ,"[{'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Irwin', 'Affiliation': 'Private Practice, Tarrington, CT, USA.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Baldwin', 'Affiliation': 'Department of Physiology, School of Medicine, University of Arizona School of Medicine, Tucson, AZ, USA.'}, {'ForeName': 'Virgil I', 'Initials': 'VI', 'LastName': 'Stenberg', 'Affiliation': 'University of North Dakota, Grand Forks, ND, USA.'}]",Journal of inflammation research,['10.2147/JIR.S195165']
3344,31610549,Rivaroxaban Versus Vitamin K Antagonist in Antiphospholipid Syndrome: A Randomized Noninferiority Trial.,"Background


The potential role of new oral anticoagulants in antiphospholipid antibody syndrome (APS) remains uncertain.
Objective


To determine whether rivaroxaban is noninferior to dose-adjusted vitamin K antagonists (VKAs) for thrombotic APS.
Design


3-year, open-label, randomized noninferiority trial. (EU Clinical Trials Register: EUDRA [European Union Drug Regulatory Authorities] code 2010-019764-36).
Setting


6 university hospitals in Spain.
Participants


190 adults (aged 18 to 75 years) with thrombotic APS.
Intervention


Rivaroxaban (20 mg/d or 15 mg/d, according to renal function) versus dose-adjusted VKAs (target international normalized ratio, 2.0 to 3.0, or 3.1 to 4.0 in patients with a history of recurrent thrombosis).
Measurements


The primary efficacy outcome was the proportion of patients with new thrombotic events; the primary safety outcome was major bleeding. The prespecified noninferiority margin for risk ratio (RR) was 1.40. Secondary outcomes included time to thrombosis, type of thrombosis, changes in biomarker levels, cardiovascular death, and nonmajor bleeding.
Results


After 3 years of follow-up, recurrent thrombosis occurred in 11 patients (11.6%) in the rivaroxaban group and 6 (6.3%) in the VKA group (RR in the rivaroxaban group, 1.83 [95% CI, 0.71 to 4.76]). Stroke occurred more commonly in patients receiving rivaroxaban (9 events) than in those receiving VKAs (0 events) (corrected RR, 19.00 [CI, 1.12 to 321.9]). Major bleeding occurred in 6 patients (6.3%) in the rivaroxaban group and 7 (7.4%) in the VKA group (RR, 0.86 [CI, 0.30 to 2.46]). Post hoc analysis suggested an increased risk for recurrent thrombosis in rivaroxaban-treated patients with previous arterial thrombosis, livedo racemosa, or APS-related cardiac valvular disease.
Limitation


Anticoagulation intensity was not measured in the rivaroxaban group.
Conclusion


Rivaroxaban did not show noninferiority to dose-adjusted VKAs for thrombotic APS and, in fact, showed a non-statistically significant near doubling of the risk for recurrent thrombosis.
Primary Funding Source


Bayer Hispania.",2019,"Conclusion


Rivaroxaban did not show noninferiority to dose-adjusted VKAs for thrombotic APS and, in fact, showed a non-statistically significant near doubling of the risk for recurrent thrombosis.
","['Setting\n\n\n6 university hospitals in Spain', 'Participants\n\n\n190 adults (aged 18 to 75 years) with thrombotic APS', 'Antiphospholipid Syndrome']","['Rivaroxaban Versus Vitamin K Antagonist', 'vitamin K antagonists (VKAs', 'rivaroxaban', 'Rivaroxaban']","['risk ratio (RR', 'Major bleeding', 'Limitation\n\n\nAnticoagulation intensity', 'proportion of patients with new thrombotic events; the primary safety outcome was major bleeding', 'recurrent thrombosis', 'time to thrombosis, type of thrombosis, changes in biomarker levels, cardiovascular death, and nonmajor bleeding', 'Stroke']","[{'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C0085278', 'cui_str': 'Antiphospholipid Antibody Syndrome'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C3653316', 'cui_str': 'Vitamin K antagonists'}]","[{'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]",190.0,0.206485,"Conclusion


Rivaroxaban did not show noninferiority to dose-adjusted VKAs for thrombotic APS and, in fact, showed a non-statistically significant near doubling of the risk for recurrent thrombosis.
","[{'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Ordi-Ros', 'Affiliation': ""Vall d'Hebrón Research Institute, Barcelona, Spain (J.O., X.V., C.S., J.C.).""}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Sáez-Comet', 'Affiliation': 'Miguel Servet Hospital, Zaragoza, Spain (L.S., M.P.).'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Pérez-Conesa', 'Affiliation': 'Miguel Servet Hospital, Zaragoza, Spain (L.S., M.P.).'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Vidal', 'Affiliation': ""Vall d'Hebrón Research Institute, Barcelona, Spain (J.O., X.V., C.S., J.C.).""}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Riera-Mestre', 'Affiliation': 'Bellvitge University Hospital-IDIBELL, Barcelona, Spain (A.R.).'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Castro-Salomó', 'Affiliation': 'Sant Joan de Reus University Hospital, Reus, Spain (A.C.).'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Cuquet-Pedragosa', 'Affiliation': 'Granollers University Hospital, Granollers, Spain (J.C., V.O.).'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Ortiz-Santamaria', 'Affiliation': 'Granollers University Hospital, Granollers, Spain (J.C., V.O.).'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Mauri-Plana', 'Affiliation': 'Mataró Hospital, Mataró, Spain (M.M.).'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Solé', 'Affiliation': ""Vall d'Hebrón Research Institute, Barcelona, Spain (J.O., X.V., C.S., J.C.).""}, {'ForeName': 'Josefina', 'Initials': 'J', 'LastName': 'Cortés-Hernández', 'Affiliation': ""Vall d'Hebrón Research Institute, Barcelona, Spain (J.O., X.V., C.S., J.C.).""}]",Annals of internal medicine,['10.7326/M19-0291']
3345,31427788,Cognitive prostheses for goal achievement.,"Procrastination takes a considerable toll on people's lives, the economy and society at large. Procrastination is often a consequence of people's propensity to prioritize their immediate experiences over the long-term consequences of their actions. This suggests that aligning immediate rewards with long-term values could be a promising way to help people make more future-minded decisions and overcome procrastination. Here we develop an approach to decision support that leverages artificial intelligence and game elements to restructure challenging sequential decision problems in such a way that it becomes easier for people to take the right course of action. A series of four increasingly realistic experiments suggests that this approach can enable people to make better decisions faster, procrastinate less, complete their work on time and waste less time on unimportant tasks. These findings suggest that our method is a promising step towards developing cognitive prostheses that help people achieve their goals.",2019,"A series of four increasingly realistic experiments suggests that this approach can enable people to make better decisions faster, procrastinate less, complete their work on time and waste less time on unimportant tasks.",[],[],[],[],[],[],4.0,0.0270359,"A series of four increasingly realistic experiments suggests that this approach can enable people to make better decisions faster, procrastinate less, complete their work on time and waste less time on unimportant tasks.","[{'ForeName': 'Falk', 'Initials': 'F', 'LastName': 'Lieder', 'Affiliation': 'Max Planck Institute for Intelligent Systems, Tübingen, Germany. falk.lieder@tuebingen.mpg.de.'}, {'ForeName': 'Owen X', 'Initials': 'OX', 'LastName': 'Chen', 'Affiliation': 'Department of Electrical Engineering and Computer Science, University of California, Berkeley, CA, USA.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Krueger', 'Affiliation': 'Department of Computer Science, Princeton University, Princeton, NJ, USA.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Griffiths', 'Affiliation': 'Department of Computer Science, Princeton University, Princeton, NJ, USA.'}]",Nature human behaviour,['10.1038/s41562-019-0672-9']
3346,32011447,"The efficacy and safety of Chinese herbal medicine Shen-Qi Hua-Yu formula in patients with diabetic lower extremity artery disease: Study protocol of a multi-center, randomized, double-blind, placebo-controlled trial.","BACKGROUND


Lower extremity artery disease (LEAD) is greatly harmful to Type 2 Diabetes Mellitus patients. Traditional Chinese Medicine (TCM) is an alternative therapy to delay the development of macrovascular diseases, but the existing evidence of its efficacy, safety and mechanism of action is insufficient. We report a study protocol of a multi-center, randomized, double-blind, placebo-controlled trial that aims to use well-designed clinical trial to evaluate the efficacy and safety of Chinese herbal medicine (CHM) Shen-Qi Hua-Yu formula, and to explore efficacy mechanism of the TCM granules and the biomarkers of TCM syndrome.
METHODS


This is a multi-center, double-blind, randomized, and placebo-controlled study that randomized 120 participants into 2 groups. The treatment group will receive TCM granules and conventional medicine, while the control group will receive placebo in addition to conventional medicine. Two groups will receive 12-week treatment and 48-week follow-up, with a total of 13 visits. Primary efficacy outcomes included ankle brachial index. Secondary efficacy outcomes included fasting plasma glucose, blood lipid, hemorheology indexes, advanced glycation end products, the inner diameter, peak systolic velocity, end diastolic velocity and mean average velocity of the anterior tibial artery, posterior tibial artery and dorsalis pedis artery, and TCM syndrome score. The safety and endpoint outcomes will be evaluated in this trial. The study will explain the biological therapeutic mechanism of Shen-Qi Hua-Yu formula for diabetic LEAD, and try to use Isobaric tags for Relative and Absolute Quantitation (iTRAQ) and Western blot to screen biomarkers of characteristic diagnosis and clinical efficiency evaluation of the TCM syndrome.
DISCUSSION


This study is a multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of CHM in patients with diabetic LEAD, and to interpret the therapeutic mechanism of Shen-Qi Hua-Yu formula in treatment of diabetic LEAD through proteomics technology, and to screen biomarkers with characteristics of TCM diagnosis and clinical efficacy evaluation. On the other hand, to our knowledge, this study may be the first trial of CHM formulas to observe cardiovascular outcomes through long-term follow-up for the treatment of diabetic LEAD, which is of great value.
TRIAL REGISTRATION


This study is registered on the Chinese Clinical Trial Registry: ChiCTR1900026372.",2020,"The treatment group will receive TCM granules and conventional medicine, while the control group will receive placebo in addition to conventional medicine.","['Chinese Clinical Trial Registry', 'patients with diabetic lower extremity artery disease', 'patients with diabetic LEAD', 'Type 2 Diabetes Mellitus patients', '120 participants into 2 groups']","['Chinese herbal medicine Shen-Qi Hua-Yu formula', 'Chinese herbal medicine (CHM', 'TCM granules and conventional medicine', 'placebo', 'Traditional Chinese Medicine (TCM', 'CHM']","['ankle brachial index', 'fasting plasma glucose, blood lipid, hemorheology indexes, advanced glycation end products, the inner diameter, peak systolic velocity, end diastolic velocity and mean average velocity of the anterior tibial artery, posterior tibial artery and dorsalis pedis artery, and TCM syndrome score', 'efficacy and safety']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0003842', 'cui_str': 'Arteries'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1273412', 'cui_str': 'Chinese herbal medicine'}, {'cui': 'C3853573', 'cui_str': 'Granules'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025124', 'cui_str': 'Zhong Yi Xue'}]","[{'cui': 'C1328319', 'cui_str': 'Ankle Brachial Index'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0206502', 'cui_str': 'Hemorheology'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0162574', 'cui_str': 'Advanced Glycation Endproducts'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0085816', 'cui_str': 'Anterior Tibial Artery'}, {'cui': 'C0086835', 'cui_str': 'Posterior Tibial Artery'}, {'cui': 'C0226492', 'cui_str': 'Structure of dorsalis pedis artery'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",120.0,0.38616,"The treatment group will receive TCM granules and conventional medicine, while the control group will receive placebo in addition to conventional medicine.","[{'ForeName': 'Yulin', 'Initials': 'Y', 'LastName': 'Leng', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, PR China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Gao', 'Affiliation': ''}, {'ForeName': 'Xiaoxu', 'Initials': 'X', 'LastName': 'Fu', 'Affiliation': ''}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': ''}, {'ForeName': 'Zhipeng', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Xiaoke', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Xiujuan', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Ziyan', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': ''}, {'ForeName': 'Chunguang', 'Initials': 'C', 'LastName': 'Xie', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000018713']
3347,32011448,Fully covered self-expandable metal stent with an anti-migration system vs plastic stent for distal biliary obstruction caused by borderline resectable pancreatic cancer: A protocol for systematic review.,"BACKGROUND AND AIM


Biliary obstruction can impair the effectiveness of neo-adjuvant chemotherapy. This study was designed to compare biliary stenting with covered self-expandable metal stents (FCSEMS) and plastic stents (PS) in patients with biliary obstruction caused by borderline resectable pancreatic cancer (BRPC) who were undergoing neo-adjuvant chemotherapy during preoperative biliary drainage.
METHODS


This single-center, comparative, randomized, superiority study was designed to compare FCSEMS with PS for drainage of biliary obstruction of BRPC. Twenty two eligible patients providing informed consent will be randomized 1:1 by computer to either FCSEMS or PS for endoscopic retrograde biliary drainage (ERBD). All subsequent clinical interventions, including crossover to alternative procedures, will be at the discretion of the treating physician based on standard clinical care. The primary outcomes will be the rates and causes of stent dysfunction during preoperative biliary drainage. Other outcomes include time required for ERBD, adverse events related to ERBD, period from ERBD to surgery, percentage of patients able to undergo surgery, operation time, intraoperative bleeding volume, postoperative adverse events, and postoperative hospitalization. Subjects, treating clinicians, and outcome assessors will not be blinded to assignment.
DISCUSSION


This study is intended to determine whether FCSEMS or PS is the better biliary stent for ERBD for management of patients with biliary obstruction of BRPC, a common clinical dilemma that has not yet been investigated in randomized trials.
TRIALS REGISTRATION


UMIN-CTR, Identifier: UMIN000030473. Registered July 10, 2017, Wakayama Medical University Hospital.",2020,"This study was designed to compare biliary stenting with covered self-expandable metal stents (FCSEMS) and plastic stents (PS) in patients with biliary obstruction caused by borderline resectable pancreatic cancer (BRPC) who were undergoing neo-adjuvant chemotherapy during preoperative biliary drainage.
","['Twenty two eligible patients providing informed consent', 'Registered July 10, 2017, Wakayama Medical University Hospital', 'patients with biliary obstruction caused by borderline resectable pancreatic cancer (BRPC) who were undergoing neo-adjuvant chemotherapy during preoperative biliary drainage', 'patients with biliary obstruction of BRPC', 'borderline resectable pancreatic cancer']","['FCSEMS or PS for endoscopic retrograde biliary drainage (ERBD', 'Fully covered self-expandable metal stent with an anti-migration system vs plastic stent', 'FCSEMS', 'biliary stenting with covered self-expandable metal stents (FCSEMS) and plastic stents (PS']","['rates and causes of stent dysfunction during preoperative biliary drainage', 'time required for ERBD, adverse events related to ERBD, period from ERBD to surgery, percentage of patients able to undergo surgery, operation time, intraoperative bleeding volume, postoperative adverse events, and postoperative hospitalization']","[{'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0400745', 'cui_str': 'Biliary drainage (procedure)'}]","[{'cui': 'C0439784', 'cui_str': 'Retrograde direction (qualifier value)'}, {'cui': 'C0400745', 'cui_str': 'Biliary drainage (procedure)'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}, {'cui': 'C4042807', 'cui_str': 'Self Expandable Metal Stents'}, {'cui': 'C1533574', 'cui_str': 'Migration, function (observable entity)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0441289', 'cui_str': 'Plastic stent (physical object)'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0400745', 'cui_str': 'Biliary drainage (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",22.0,0.138468,"This study was designed to compare biliary stenting with covered self-expandable metal stents (FCSEMS) and plastic stents (PS) in patients with biliary obstruction caused by borderline resectable pancreatic cancer (BRPC) who were undergoing neo-adjuvant chemotherapy during preoperative biliary drainage.
","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Tamura', 'Affiliation': 'Second Department of Internal Medicine.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Yamaue', 'Affiliation': 'Second Department of Surgery.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Itonaga', 'Affiliation': 'Second Department of Internal Medicine.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Kawaji', 'Affiliation': 'Second Department of Internal Medicine.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Nuta', 'Affiliation': 'Second Department of Internal Medicine.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Hatamaru', 'Affiliation': 'Second Department of Internal Medicine.'}, {'ForeName': 'Yasunobu', 'Initials': 'Y', 'LastName': 'Yamashita', 'Affiliation': 'Second Department of Internal Medicine.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Kitahata', 'Affiliation': 'Second Department of Surgery.'}, {'ForeName': 'Motoki', 'Initials': 'M', 'LastName': 'Miyazawa', 'Affiliation': 'Second Department of Surgery.'}, {'ForeName': 'Seiko', 'Initials': 'S', 'LastName': 'Hirono', 'Affiliation': 'Second Department of Surgery.'}, {'ForeName': 'Ken-Ichi', 'Initials': 'KI', 'LastName': 'Okada', 'Affiliation': 'Second Department of Surgery.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Kawai', 'Affiliation': 'Second Department of Surgery.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Shimokawa', 'Affiliation': 'Clinical Study Support Center, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Kitano', 'Affiliation': 'Second Department of Internal Medicine.'}]",Medicine,['10.1097/MD.0000000000018718']
3348,31373648,Effect of First-line S-1 Plus Oxaliplatin With or Without Ramucirumab Followed by Paclitaxel Plus Ramucirumab on Advanced Gastric Cancer in East Asia: The Phase 2 RAINSTORM Randomized Clinical Trial.,"Importance


Ramucirumab, a human IgG 1 antibody against vascular endothelial growth factor receptor 2, has been shown to improve progression-free survival and overall survival in patients with advanced gastric cancer in the second-line setting.
Objective


To compare progression-free survival for S-1 and oxaliplatin plus ramucirumab with that for S-1 and oxaliplatin plus placebo in patients with advanced gastric cancer.
Design, Setting, and Participants


This phase 2, double-blind randomized clinical trial (RAINSTORM [First-line S-1 Plus Oxaliplatin With or Without Ramucirumab Followed by Paclitaxel Plus Ramucirumab in Patients With Advanced Gastric Cancer]) was conducted from October 12, 2015, to April 11, 2018, at 36 sites in Japan, South Korea, and Taiwan. Participants were chemotherapy-naive patients (n = 189) with metastatic gastric or gastroesophageal adenocarcinoma. Analyses of the full analysis set and safety population were conducted between November 27, 2017, and June 4, 2018.
Interventions


Patients randomized to the ramucirumab plus S-1 and oxaliplatin arm received S-1, 80 to 120 mg/d twice daily, on days 1 to 14 and oxaliplatin, 100 mg/m2, on day 1 with ramucirumab, 8 mg/kg, on days 1 and 8 in part A (21-day cycle). Patients randomized to the placebo plus S-1 and oxaliplatin arm received the same S-1 and oxaliplatin dosage as well as placebo on days 1 and 8 in part A. Eligible patients received second-line paclitaxel, 80 mg/m2, on days 1, 8, and 15 and ramucirumab, 8 mg/kg, on days 1 and 15 in part B (28-day cycle).
Main Outcomes and Measures


The primary end point was progression-free survival, analyzed using the stratified log-rank test; the hazard ratio (HR) was estimated using the stratified Cox proportional hazards regression model. Secondary end points included overall survival and adverse events.
Results


In total, 189 patients were randomized and received treatment: 96 to the ramucirumab plus S-1 and oxaliplatin arm and 93 to the placebo plus S-1 and oxaliplatin arm. Among the 189 patients, 121 (64.0%) were male, and the median (range) age was 62.0 (26-84) years. Median progression-free survival was not prolonged in the ramucirumab plus S-1 and oxaliplatin arm compared with the placebo plus S-1 and oxaliplatin arm (6.34 [80% CI, 5.65-6.93] vs 6.74 [80% CI, 5.75-7.13] months; HR, 1.07; 80% CI, 0.86-1.33; P = .70). Median overall survival was 14.65 (80% CI, 12.39-15.67) months in the ramucirumab plus S-1 and oxaliplatin arm and 14.26 (80% CI, 13.83-17.31) months in the placebo plus S-1 and oxaliplatin arm (HR, 1.11; 80% CI, 0.89-1.40; P = .55). The most commonly reported grade 3 or higher treatment-emergent adverse events in the ramucirumab plus S-1 and oxaliplatin arm in part A were decreased neutrophil count (14 patients [14.6%]), hypertension (10 patients [10.4%]), and anemia (10 patients [10.4%]).
Conclusions and Relevance


In this randomized clinical trial, the addition of ramucirumab to first-line S-1 and oxaliplatin treatment did not prolong progression-free survival or overall survival compared with S-1 and oxaliplatin alone among East Asian patients with advanced gastric cancer; no new safety signals for ramucirumab were identified.
Trial Registration


ClinicalTrials.gov identifier: NCT02539225.",2019,"Median progression-free survival was not prolonged in the ramucirumab plus S-1 and oxaliplatin arm compared with the placebo plus S-1 and oxaliplatin arm (6.34 [80% CI, 5.65-6.93] vs 6.74 [80% CI, 5.75-7.13] months; HR, 1.07; 80% CI, 0.86-1.33; P = .70).","['189 patients, 121 (64.0%) were male, and the median (range) age was 62.0 (26-84) years', '189 patients', 'patients with advanced gastric cancer in the second-line setting', 'East Asian patients with advanced gastric cancer', 'Advanced Gastric Cancer in East Asia', 'Participants were chemotherapy-naive patients (n\u2009=\u2009189) with metastatic gastric or gastroesophageal adenocarcinoma', 'Patients With Advanced Gastric Cancer]) was conducted from October 12, 2015, to April 11, 2018, at 36 sites in Japan, South Korea, and Taiwan', 'patients with advanced gastric cancer']","['S-1 and oxaliplatin', 'First-line S-1 Plus Oxaliplatin With or Without Ramucirumab Followed by Paclitaxel Plus Ramucirumab', 'Oxaliplatin With or Without Ramucirumab Followed by Paclitaxel Plus Ramucirumab', 'S-1 and oxaliplatin plus ramucirumab', 'placebo', 'ramucirumab to first-line S-1 and oxaliplatin', 'second-line paclitaxel', 'ramucirumab plus S-1 and oxaliplatin', 'S-1 and oxaliplatin plus placebo', 'oxaliplatin', 'placebo plus S-1 and oxaliplatin', 'S-1 and oxaliplatin alone']","['progression-free survival or overall survival', 'overall survival and adverse events', 'progression-free survival', 'hazard ratio (HR', 'Median overall survival', 'hypertension', 'Median progression-free survival', 'progression-free survival and overall survival', 'neutrophil count']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0015631', 'cui_str': 'East Asia'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}]","[{'cui': 'C0879262', 'cui_str': 'TS-1 cpd'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count (procedure)'}]",189.0,0.425559,"Median progression-free survival was not prolonged in the ramucirumab plus S-1 and oxaliplatin arm compared with the placebo plus S-1 and oxaliplatin arm (6.34 [80% CI, 5.65-6.93] vs 6.74 [80% CI, 5.75-7.13] months; HR, 1.07; 80% CI, 0.86-1.33; P = .70).","[{'ForeName': 'Takaki', 'Initials': 'T', 'LastName': 'Yoshikawa', 'Affiliation': 'Department of Gastrointestinal Surgery, Kanagawa Cancer Center Hospital, Yokohama, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Shitara', 'Affiliation': 'Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Do-Youn', 'Initials': 'DY', 'LastName': 'Oh', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Yoon-Koo', 'Initials': 'YK', 'LastName': 'Kang', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan, Seoul, South Korea.'}, {'ForeName': 'Hyun Cheol', 'Initials': 'HC', 'LastName': 'Chung', 'Affiliation': 'Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Kudo', 'Affiliation': 'Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Keisho', 'Initials': 'K', 'LastName': 'Chin', 'Affiliation': 'The Cancer Institute Hospital of the Japanese Foundation of Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Shigenori', 'Initials': 'S', 'LastName': 'Kadowaki', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Hamamoto', 'Affiliation': 'Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Hironaka', 'Affiliation': 'Chiba Cancer Center, Chiba, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': 'Graduate School of Medicine, Gifu University, Gifu, Japan.'}, {'ForeName': 'Chia-Jui', 'Initials': 'CJ', 'LastName': 'Yen', 'Affiliation': 'Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Omuro', 'Affiliation': 'Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan.'}, {'ForeName': 'Li-Yuan', 'Initials': 'LY', 'LastName': 'Bai', 'Affiliation': 'Division of Hematology and Oncology, China Medical University Hospital, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Kaijiro', 'Initials': 'K', 'LastName': 'Maeda', 'Affiliation': 'Eli Lilly Japan KK, Kobe, Japan.'}, {'ForeName': 'Akichika', 'Initials': 'A', 'LastName': 'Ozeki', 'Affiliation': 'Eli Lilly Japan KK, Kobe, Japan.'}, {'ForeName': 'Reigetsu', 'Initials': 'R', 'LastName': 'Yoshikawa', 'Affiliation': 'Eli Lilly Japan KK, Kobe, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Kitagawa', 'Affiliation': 'Keio University School of Medicine, Tokyo, Japan.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.8243']
3349,31371150,Comparison of effective phacoemulsification time and corneal endothelial cell loss using 2 ultrasound frequencies.,"PURPOSE


To compare 2 ultrasound (US) frequencies for phacoemulsification for moderate to hard cataract to determine a frequency that makes phacoemulsification safer and more efficacious.
SETTING


Post Graduate Institute of Medical Education and Research, New Delhi, India.
DESIGN


Randomized controlled trial.
METHODS


Patients with grade 4.0 to 6.9 senile cataract were randomized to 2 groups. Group A had lower frequency (28 kHz) phacoemulsification, and Group B had higher frequency (42 kHz) phacoemulsification. The effective phacoemulsification time (EPT) and estimated fluid usage (EFU) were compared intraoperatively. The endothelial parameters were assessed over 1 year.
RESULTS


Both groups comprised 80 patients. The groups were matched for age (P = .533), sex (P = .263), and nuclear grade (nuclear color, P = .496; nuclear opalescence, P = .622). Group B had significant reductions in EPT (P = .008) and EFU (P = .004) compared with Group A. Postoperatively, the endothelial cell density (ECD) was significantly higher in Group B at 1 month (P = .004), 3 months (P = .003), 6 months (P = .004), 9 months (P = .002), and 1 year (P = .003). The percentages of ECD loss were also significantly lower in Group B; the difference was statistically significant up to 1 year postoperatively even after adjustments for age, grade of cataract, EPT, and EFU.
CONCLUSION


Higher frequency phacoemulsification was associated with a lower EPT and EFU as well as better endothelial preservation than a lower frequency.",2019,"The percentages of ECD loss were also significantly lower in Group B; the difference was statistically significant up to 1 year postoperatively even after adjustments for age, grade of cataract, EPT, and EFU.
","['Post Graduate Institute of Medical Education and Research, New Delhi, India', 'Patients with grade 4.0 to 6.9 senile cataract']",[],"['corneal endothelial cell loss', 'endothelial parameters', 'ECD loss', 'EFU', 'endothelial cell density (ECD', 'effective phacoemulsification time (EPT) and estimated fluid usage (EFU', 'EPT']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0588053', 'cui_str': 'Graduate (person)'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0013631', 'cui_str': 'Education, Medical'}, {'cui': 'C0035168'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C0036646', 'cui_str': 'Age-related cataract (disorder)'}]",[],"[{'cui': 'C2717756', 'cui_str': 'Corneal Endothelial Cell Damage'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell count'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0039512', 'cui_str': 'Teniposide'}]",80.0,0.0299274,"The percentages of ECD loss were also significantly lower in Group B; the difference was statistically significant up to 1 year postoperatively even after adjustments for age, grade of cataract, EPT, and EFU.
","[{'ForeName': 'Taru', 'Initials': 'T', 'LastName': 'Dewan', 'Affiliation': 'Post Graduate Institute of Medical Education and Research, Dr. Ram Manohar Lohia Hospital, New Delhi, India. Electronic address: drtarudewan@gmail.com.'}, {'ForeName': 'Praveen Kumar', 'Initials': 'PK', 'LastName': 'Malik', 'Affiliation': 'Post Graduate Institute of Medical Education and Research, Dr. Ram Manohar Lohia Hospital, New Delhi, India.'}, {'ForeName': 'Ritu', 'Initials': 'R', 'LastName': 'Kumari', 'Affiliation': 'Post Graduate Institute of Medical Education and Research, Dr. Ram Manohar Lohia Hospital, New Delhi, India.'}]",Journal of cataract and refractive surgery,['10.1016/j.jcrs.2019.04.015']
3350,31354946,The effects of auditory spatial training on informational masking release in elderly listeners: a study protocol for a randomized clinical trial.,"Background:  Regarding the strong auditory spatial plasticity capability of the central auditory system and the effect of short-term and long-term rehabilitation programs in elderly people, it seems that an auditory spatial training can help this population in informational masking release and better track speech in noisy environments. The main purposes of this study are developing an informational masking measurement test and an auditory spatial training program.  Protocol:  This study will be conducted in two parts. Part 1: develop and determine the validity of an informational masking measurement test by recruiting two groups of young (n=50) and old (n=50) participants with normal hearing who have no difficulty in understanding speech in noisy environments. Part 2 (clinical trial): two groups of 60-75-year-olds with normal hearing, who complain about difficulty in speech perception in noisy environments, will participate as control and intervention groups to examine the effect of auditory spatial training. Intervention: 15 sessions of auditory spatial training. The informational masking measurement test and Speech, Spatial and Qualities of Hearing Scale will be compared before intervention, immediately after intervention, and five weeks after intervention between the two groups.  Discussion:  Since auditory training programs do not deal with informational masking release, an auditory spatial training will be designed, aiming to improve hearing in noisy environments for elderly populations.  Trial registration:  Iranian Registry of Clinical Trials ( IRCT20190118042404N1) on 25  th  February 2019.",2019,"two groups of 60-75-year-olds with normal hearing, who complain about difficulty in speech perception in noisy environments, will participate as control and intervention groups to examine the effect of auditory spatial training.","['two groups of young (n=50) and old (n=50) participants with normal hearing who have no difficulty in understanding speech in noisy environments', '25  th  February 2019', 'two groups of 60-75-year-olds with normal hearing, who complain about difficulty in speech perception in noisy environments', 'elderly listeners', 'elderly people']","['short-term and long-term rehabilitation programs', 'auditory spatial training']","['informational masking measurement test and Speech, Spatial and Qualities of Hearing Scale', 'informational masking release']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0563025', 'cui_str': 'Noisy environment (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037826', 'cui_str': 'Speech Perception'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0018767', 'cui_str': 'Audition'}, {'cui': 'C0222045'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]",,0.0363944,"two groups of 60-75-year-olds with normal hearing, who complain about difficulty in speech perception in noisy environments, will participate as control and intervention groups to examine the effect of auditory spatial training.","[{'ForeName': 'Farnoush', 'Initials': 'F', 'LastName': 'Jarollahi', 'Affiliation': 'Department of Audiology, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Amiri', 'Affiliation': 'Department of Audiology, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shohreh', 'Initials': 'S', 'LastName': 'Jalaie', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation Sciences, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyyed Jalal', 'Initials': 'SJ', 'LastName': 'Sameni', 'Affiliation': 'Department of Audiology, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.'}]",F1000Research,['10.12688/f1000research.18602.2']
3351,32067764,"Letter regarding ""Radiation exposure during direct versus indirect image acquisition during fluoroscopy-controlled internal fixation of a hip fracture: Results of a randomized controlled trial"".",,2020,,['a hip fracture'],"['Letter regarding ""Radiation exposure during direct versus indirect image acquisition during fluoroscopy-controlled internal fixation of']",[],"[{'cui': 'C0019557', 'cui_str': 'Hip Fractures'}]","[{'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation (event)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0439852', 'cui_str': 'Indirect (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}]",[],,0.0562403,,"[{'ForeName': 'Natsumi', 'Initials': 'N', 'LastName': 'Saka', 'Affiliation': 'Department of Orthopaedics, Teikyo University School of Medicine, 1-2-11, Kaga, Itabashi, Tokyo, Japan. Electronic address: natsumi613@gmail.com.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Banno', 'Affiliation': 'Department of Psychiatry, Seichiryo Hospital, Tsurumai 4-16-27, Showa-ku, Nagoya 466-0064, Japan; Department of Psychiatry, Nagoya University Graduate School of Medicine, Tsurumai-cho 65, Showa-ku, Nagoya 466-8560, Japan; Systematic Review Workshop Peer Support Group (SRWS-PSG), Japan. Electronic address: solvency@med.nagoya-u.ac.jp.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Tsujimoto', 'Affiliation': 'Systematic Review Workshop Peer Support Group (SRWS-PSG), Japan; Department of Nephrology and Dialysis, Kyoritsu Hospital, Chuo-cho 16-5, Kawanishi 666-0016, Japan; Department of Healthcare Epidemiology, School of Public Health in the Graduate School of Medicine, Kyoto University, Yoshida Konoe-cho, Sakyo-ku, Kyoto 606-8501, Japan. Electronic address: yssh0108@yahoo.co.jp.'}]",Injury,['10.1016/j.injury.2020.02.025']
3352,32064621,Mannuronic Acid in Low-Risk and Intermediate-1-Risk Myelodysplastic Syndromes.,"The discovery of hematologic improvement and bone marrow modification by the drug β-D mannuronic acid (M2000) during treatment of rheumatoid arthritis in phase 1/2/3 clinical trials prompted us to design a new trial to target hematologic deficits in myelodysplastic syndromes (MDS). In this open-label, randomized phase 2 clinical trial, the potential effect and tolerability of drug M2000 was assessed in patients with low- and intermediate-1-risk MDS. The primary efficacy end point was hematologic improvement after 12 weeks of β-D-mannuronic acid therapy. Among 34 enrolled patients, half received their conventional therapy plus β-D-mannuronic acid, and the other half received only conventional drugs. In the conventional + β-D mannuronic acid treatment group, hematologic improvement and development of transfusion independence and/or reduction in transfusion requirements were seen in 12 patients (92.3%) and 1 patient (7.7%), respectively. Moreover, 5 patients (38.5%), 2 patients (15.4%), and 1 patient (7.7%) in the β-D-mannuronic acid-treated group showed hematologic improvement of the major parameters of erythroid, neutrophil, and platelet responses, respectively, based on the International Working Group criteria), whereas in the conventional treatment group as control, no hematologic improvements including erythroid, neutrophil, and platelet response was seen. In this trial, the addition of β-D mannuronic acid to conventional treatment showed promising results in MDS patients with low and intermediate-1 risk with effects on hematologic improvements without significant adverse effect.",2020,"In the conventional + β-D mannuronic acid treatment group, hematologic improvement and development of transfusion independence and/or reduction in transfusion requirements were seen in 12 patients (92.3%) and 1 patient (7.7%), respectively.","['patients with low- and intermediate-1-risk MDS', '34 enrolled patients, half received their']","['Mannuronic Acid', 'conventional therapy plus β-D-mannuronic acid, and the other half received only conventional drugs']","['hematologic improvement of the major parameters of erythroid, neutrophil, and platelet responses', 'hematologic improvement', 'hematologic improvements including erythroid, neutrophil, and platelet response', 'hematologic improvement and development of transfusion independence and/or reduction in transfusion requirements']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}]","[{'cui': 'C0162988', 'cui_str': 'mannuronic acid'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",34.0,0.0192793,"In the conventional + β-D mannuronic acid treatment group, hematologic improvement and development of transfusion independence and/or reduction in transfusion requirements were seen in 12 patients (92.3%) and 1 patient (7.7%), respectively.","[{'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Ghaderi', 'Affiliation': 'Department of Internal Medicine, Hematology and Medical Oncology Ward, Cancer Research Centre, Cancer Institute, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sayyed Reza Safaee', 'Initials': 'SRS', 'LastName': 'Nodehi', 'Affiliation': 'Department of Internal Medicine, Hematology and Medical Oncology Ward, Cancer Research Centre, Cancer Institute, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Bakhtiari', 'Affiliation': 'Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Aslani', 'Affiliation': 'Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Aghazadeh', 'Affiliation': 'Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Matsuo', 'Affiliation': 'Nagasaki National Hospital, Nagasaki, Japan.'}, {'ForeName': 'Bernd H A', 'Initials': 'BHA', 'LastName': 'Rehm', 'Affiliation': 'Centre for Cell Factories and Biopolymers, Griffith Institute for Drug Discovery, Griffith University, Nathan, Queensland, Australia.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Cuzzocrea', 'Affiliation': 'Department of Chemical, Biological, Pharmaceutical and Environmental Sciences, University of Messina, Messina, Italy.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Mirshafiey', 'Affiliation': 'Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}]",Journal of clinical pharmacology,['10.1002/jcph.1587']
3353,32048278,Determining the effective pre-oxygenation interval in obstetric patients using high-flow nasal oxygen and standard flow rate facemask: a biased-coin up-down sequential allocation trial.,"Using biased-coin sequential allocation, we sought to determine the effective time interval in 90% of healthy parturients to achieve a target endpoint end-tidal oxygen of ≥ 90% using standard flow rate facemask and high-flow nasal oxygen. Eighty healthy parturients were randomly assigned to standard facemask (n = 40) or high-flow nasal oxygen (n = 40) groups; half of the parturients in the high-flow nasal oxygen group also used a simple no-flow facemask to minimise air entrainment. The effective time interval for 90% of parturients to achieve the target endpoint for standard facemask was 3.6 min (95%CI 3.3-6.7 min), but could not be estimated for the high-flow nasal oxygen groups with or without an additional simple facemask, as eight minutes was insufficient to achieve the target endpoint for 55% and 92% of parturients, respectively. Furthermore, after three minutes, the target endpoint was reached by 71% in the standard facemask group vs. 0% in the high-flow nasal oxygen groups. After four minutes, the target endpoint was reached by 100% in the standard facemask, 80% in the high-flow nasal oxygen with simple facemask and 67% in the high-flow nasal oxygen groups. Beyond four minutes, there was no improvement in pre-oxygenation success using high-flow nasal oxygen. In conclusion, under the conditions of our study, the effective time interval for 90% of parturients to achieve an end-tidal oxygen ≥ 90% for standard flow rate facemask was estimated to be 3.6 min, but could not be estimated for high-flow nasal oxygen groups even after eight minutes.",2020,"Beyond four minutes, there was no improvement in pre-oxygenation success using high-flow nasal oxygen.","['obstetric patients using high', 'Eighty healthy parturients']","['standard facemask (n\xa0=\xa040) or high-flow nasal oxygen (n\xa0=\xa040) groups; half of the parturients in the high-flow nasal oxygen group also used a simple no-flow facemask to minimise air entrainment', 'flow nasal oxygen and standard flow rate facemask', 'standard flow rate facemask and high-flow nasal oxygen']","['effective time interval', 'pre-oxygenation success']","[{'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0001861', 'cui_str': 'Air'}]","[{'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]",,0.0489449,"Beyond four minutes, there was no improvement in pre-oxygenation success using high-flow nasal oxygen.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Au', 'Affiliation': ""British Columbia Women's Hospital, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Shippam', 'Affiliation': ""British Columbia Women's Hospital, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': ""British Columbia Women's Hospital, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Albert', 'Affiliation': ""Women's Health Research Institute, Vancouver, BC, Canada.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Chau', 'Affiliation': ""British Columbia Women's Hospital, University of British Columbia, Vancouver, BC, Canada.""}]",Anaesthesia,['10.1111/anae.14995']
3354,31278808,Treatment for human visceral leishmaniasis: a cost-effectiveness analysis for Brazil.,"OBJECTIVE


To estimate the cost-effectiveness of strategies for the treatment of VL in Brazil.
METHODS


Cost-effectiveness study comparing three therapeutic options: meglumine antimoniate (MA), liposomal amphotericin B (LAMB) and a combination of LAMB plus MA (LAMB plus MA), from public health system and societal perspectives. An analytical decision-making model was used to compare strategies for the following outcomes: early therapeutic failure avoided at 30 days, days of hospitalisation avoided and VL cure at 180 days. The efficacy and safety parameters of the drugs came from a randomised, open-label trial and the cost data came from a cost-of-illness study, both carried out in Brazil.
RESULTS


For all outcomes analysed, the LAMB strategy was more effective. The MA strategy was inferior to the LAMB plus MA strategy for the outcomes early therapeutic failure avoided and cure. When only LAMB and MA were compared from a societal perspective, a cost of US$ 278.56 was estimated for each additional early therapeutic failure avoided, a cost of US$ 26.88 for each additional day of hospitalisation avoided and a cost of US$ 89.88 for each additional case of cured VL, for the LAMB strategy vs. MA.
CONCLUSION


In Brazil, the LAMB strategy proved to be cost-effective for treating VL, considering a GDP per capita as the willingness-to-pay threshold, for all of the outcomes analysed in comparison to MA.",2019,"An analytical decision-making model was used to compare strategies for the following outcomes: early therapeutic failure avoided at 30 days, days of hospitalisation avoided and VL cure at 180 days.",['human visceral leishmaniasis'],"['LAMB plus MA (LAMB plus MA', 'meglumine antimoniate (MA), liposomal amphotericin B (LAMB']",['efficacy and safety parameters'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0023290', 'cui_str': 'Black Fever'}]","[{'cui': 'C0452875', 'cui_str': 'Lamb - meat (substance)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1096768', 'cui_str': 'meglumine antimoniate'}, {'cui': 'C1145701', 'cui_str': 'amphotericin B liposomal'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0309565,"An analytical decision-making model was used to compare strategies for the following outcomes: early therapeutic failure avoided at 30 days, days of hospitalisation avoided and VL cure at 180 days.","[{'ForeName': 'Isis Polianna Silva Ferreira', 'Initials': 'IPSF', 'LastName': 'de Carvalho', 'Affiliation': 'Centre for Tropical Medicine, University of Brasilia, Brasilia, Brazil.'}, {'ForeName': 'Henry Maia', 'Initials': 'HM', 'LastName': 'Peixoto', 'Affiliation': 'Centre for Tropical Medicine, University of Brasilia, Brasilia, Brazil.'}, {'ForeName': 'Gustavo Adolfo Sierra', 'Initials': 'GAS', 'LastName': 'Romero', 'Affiliation': 'Centre for Tropical Medicine, University of Brasilia, Brasilia, Brazil.'}, {'ForeName': 'Maria Regina Fernandes', 'Initials': 'MRF', 'LastName': 'de Oliveira', 'Affiliation': 'Centre for Tropical Medicine, University of Brasilia, Brasilia, Brazil.'}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13284']
3355,30778518,A Case for Promoting Movement Medicine: Preventing Disability in the LIFE Randomized Controlled Trial.,"BACKGROUND


The movement profile of older adults with compromised function is unknown, as is the relationship between these profiles and the development of major mobility disability (MMD)-a critical clinical outcome. We first describe the dimensions of movement in older adults with compromised function and then examine whether these dimensions predict the onset of MMD.
METHODS


Older adults at risk for MMD (N = 1,022, mean age = 78.7 years) were randomized to receive a structured physical activity intervention or health education control. We assessed MMD in 6-month intervals (average follow-up of 2.2 years until incident MMD), with activity assessed at baseline, 6-, 12- and 24-month follow-up via accelerometry.
RESULTS


A principal components analysis of 11 accelerometer-derived metrics yielded three components representing lifestyle movement (LM), extended bouts of moderate-to-vigorous physical activity (MVPA), and stationary body posture. LM accounted for the greatest proportion of variance in movement (53%). Within health education, both baseline LM (HR = 0.74; 95% CI 0.62 to 0.88) and moderate-to-vigorous physical activity (HR = 0.69; 95% CI 0.54 to 0.87) were associated with MMD, whereas only LM was associated with MMD within physical activity (HR = 0.74; 95% CI 0.61 to 0.89). There were similar nonlinear relationships present for LM in both physical activity and health education (p < .04), whereby risk for MMD was lower among individuals with higher levels of LM.
CONCLUSIONS


Both LM and moderate-to-vigorous physical activity should be central in treatment regimens for older adults at risk for MMD.
TRIAL REGISTRATION


clinicaltrials.gov Identifier NCT01072500.",2019,"Within HE, both baseline LM (HR=0.74; 95% CI 0.62-0.88) and MVPA (HR=0.69; 95% CI 0.54-0.87) were associated with MMD, while only LM was associated with MMD within PA (HR=0.74; 95% CI 0.61-0.89).","['older adults at risk for MMD', 'older adults with compromised function', 'Older adults at risk for MMD (N=1,022, mean age=78.7', 'older adults']","['11 accelerometer-derived metrics yielded three components representing lifestyle movement (LM), extended bouts of moderate to vigorous physical activity (MVPA), and stationary body posture', 'structured physical activity (PA) intervention or health education control (HE', 'LM and MVPA', 'LM']","['risk for MMD', 'MVPA']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439835', 'cui_str': 'Stationary (qualifier value)'}, {'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C0018701'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.114822,"Within HE, both baseline LM (HR=0.74; 95% CI 0.62-0.88) and MVPA (HR=0.69; 95% CI 0.54-0.87) were associated with MMD, while only LM was associated with MMD within PA (HR=0.74; 95% CI 0.61-0.89).","[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Fanning', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, North Carolina.'}, {'ForeName': 'W Jack', 'Initials': 'WJ', 'LastName': 'Rejeski', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, North Carolina.'}, {'ForeName': 'Shyh-Huei', 'Initials': 'SH', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Nicklas', 'Affiliation': 'Department of internal medicine, section on gerontology and geriatric medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Walkup', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Axtell', 'Affiliation': 'Department of Exercise Science, Southern Connecticut State University, New Haven.'}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Fielding', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Nutrition, Exercise Physiology and Sarcopenia Laboratory, Tufts University, Boston, Massachusetts.'}, {'ForeName': 'Nancy W', 'Initials': 'NW', 'LastName': 'Glynn', 'Affiliation': 'Department of epidemiology, University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'Abby C', 'Initials': 'AC', 'LastName': 'King', 'Affiliation': 'Department of Health Research and Policy and Stanford Prevention Research Center, Palo Alto, California.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Manini', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'McDermott', 'Affiliation': 'Devision of General Internal medicine and Geriatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Newman', 'Affiliation': 'Department Epidemiology and Medicine, University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pahor', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville.'}, {'ForeName': 'Catrine', 'Initials': 'C', 'LastName': 'Tudor-Locke', 'Affiliation': 'Department of Kinesiology, University of Massachusetts Amherst, Amherst, Massachusetts.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Miller', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glz050']
3356,32048083,"Re-establishment of efficacy of tofacitinib, an oral JAK inhibitor, after temporary discontinuation in patients with rheumatoid arthritis.","INTRODUCTION/OBJECTIVE


Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). This post-hoc analysis evaluated the effect of temporary discontinuation and reinitiation of tofacitinib on disease control in patients with RA in the vaccine sub-study of the long-term extension (LTE) study ORAL Sequel (NCT00413699).
METHODS


The sub-study of ORAL Sequel was a randomized, parallel-group, open-label study. Patients who received tofacitinib 10 mg twice daily for ≥ 3 months in ORAL Sequel were randomized to receive continuous (tofacitinib monotherapy/with methotrexate) or interrupted (tofacitinib withdrawn for 2 weeks post-randomization then reinitiated as monotherapy/with methotrexate) treatment. Efficacy assessments included ACR20/50/70 response rates, change from baseline (∆) in C-reactive protein (CRP), Health Assessment Questionnaire-Disability Index (HAQ-DI), Disease Activity Score in 28 joints, erythrocyte sedimentation rate (DAS28-4 [ESR]), Clinical Disease Activity Index (CDAI), Patient Global Assessment of arthritis (PtGA), Pain (Visual Analog Scale [VAS]), and Physician Global Assessment of arthritis (PGA). Safety was assessed throughout.
RESULTS


The sub-study included 99 patients each in the continuous and interrupted treatment groups. ACR20/50 response rates, ∆CRP, ∆HAQ-DI (day 15), ∆DAS28-4 (ESR), ∆CDAI, ∆PtGA, ∆Pain (VAS), and ∆PGA were significantly worse in interrupted vs continuous patients during dose interruption, but were generally similar to pre-interruption/continuous treatment levels 28 days post-reinitiation. A numerically higher proportion of interrupted patients reported adverse events (49.5%) vs continuous patients (35.4%).
CONCLUSIONS


Tofacitinib efficacy can be re-established after temporary withdrawal and reinitiation. The safety profile of patients who temporarily discontinued tofacitinib in the sub-study was consistent with previous tofacitinib LTE studies over 9 years.
CLINICAL TRIAL REGISTRATION NUMBER


NCT00413699 Key Points • In this sub-study of the long-term extension (LTE) study, ORAL Sequel, the efficacy of tofacitinib was re-established after temporary withdrawal (2 weeks) and reinitation of treatment in patients with RA. • Patients with RA who temporarily discontinued tofacitinib had similar safety events to those reported in previous LTE studies. • The results of this sub-study were consistent with a post-hoc analysis of pooled data from two LTE studies, ORAL Sequel and A3921041, which assessed the efficacy of tofacitinib following a treatment discontinuation period of 14-30 days.",2020,"A numerically higher proportion of interrupted patients reported adverse events (49.5%) vs continuous patients (35.4%).
","['patients with rheumatoid arthritis', 'patients with RA in the vaccine sub-study of the long-term extension (LTE) study ORAL Sequel (NCT00413699', '3\xa0months in ORAL Sequel', 'patients with RA', 'patients who temporarily discontinued tofacitinib in the sub-study was consistent with previous tofacitinib LTE studies over 9\xa0years', '99 patients each in the continuous and interrupted treatment groups', 'rheumatoid arthritis (RA']","['tofacitinib', 'tofacitinib 10\xa0mg twice daily for ≥', 'continuous (tofacitinib monotherapy/with methotrexate) or interrupted (tofacitinib withdrawn for 2 weeks post-randomization then reinitiated as monotherapy/with methotrexate']","['safety events', 'ACR20/50 response rates, ∆CRP, ∆HAQ-DI (day 15), ∆DAS28-4 (ESR), ∆CDAI, ∆PtGA, ∆Pain (VAS), and ∆PGA', 'ACR20/50/70 response rates, change from baseline (∆) in C-reactive protein (CRP), Health Assessment Questionnaire-Disability Index (HAQ-DI), Disease Activity Score in 28 joints, erythrocyte sedimentation rate (DAS28-4 [ESR]), Clinical Disease Activity Index (CDAI), Patient Global Assessment of arthritis (PtGA), Pain (Visual Analog Scale [VAS]), and Physician Global Assessment of arthritis (PGA', 'adverse events', 'Safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0243089', 'cui_str': 'sequels'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0332290', 'cui_str': 'Consistent with (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C4704009', 'cui_str': 'tofacitinib 10 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0443239', 'cui_str': 'Interrupted (qualifier value)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire (assessment scale)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0102923', 'cui_str': 'HAQ'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C3666006', 'cui_str': 'Arthritis (SMQ)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",99.0,0.278829,"A numerically higher proportion of interrupted patients reported adverse events (49.5%) vs continuous patients (35.4%).
","[{'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Kaine', 'Affiliation': 'Independent Healthcare Associates Inc, Cullowhee, NC, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Tesser', 'Affiliation': 'Arizona Arthritis & Rheumatology Associates, Glendale, AZ, USA.'}, {'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'Takiya', 'Affiliation': 'Pfizer Inc, Collegeville, PA, USA. Liza.Takiya@pfizer.com.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'DeMasi', 'Affiliation': 'Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Lisy', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Snyder', 'Affiliation': 'Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Koshika', 'Initials': 'K', 'LastName': 'Soma', 'Affiliation': 'Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'Haiyun', 'Initials': 'H', 'LastName': 'Fan', 'Affiliation': 'Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Vara', 'Initials': 'V', 'LastName': 'Bandi', 'Affiliation': 'Eliassen Group Inc, New London, CT, USA.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Wollenhaupt', 'Affiliation': 'Rheumatology im Struenseehaus, Hamburg, Germany.'}]",Clinical rheumatology,['10.1007/s10067-020-04956-1']
3357,31362530,Metformin Use and Clinical Outcomes Among Patients With Diabetes Mellitus With or Without Heart Failure or Kidney Dysfunction: Observations From the SAVOR-TIMI 53 Trial.,"BACKGROUND


Metformin is first-line therapy for type 2 diabetes mellitus, although its effects on the cardiovascular system are unproved.
METHODS


In this post hoc analysis, patients in SAVOR-TIMI 53 (Saxagliptin and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus) with baseline biomarker samples (n=12 156) were classified as ever versus never taking metformin during the trial period. Associations between metformin exposure and outcomes were estimated with inverse probability of treatment weighting Cox modeling for the composite end point of cardiovascular death, myocardial infarction, or ischemic stroke, as well as cardiovascular death and all-cause mortality, with biomarkers included as covariates. Additional sensitivity analyses included propensity score matching and Cox multivariable models.
RESULTS


Of the 12 156 patients with baseline biomarker samples, 8971 (74%) had metformin exposure, 1611 (13%) had prior heart failure, and 1332 (11%) had at least moderate chronic kidney disease (estimated glomerular filtration rate ≤45 mL·min -1 ·1.73 m -2 ). Metformin use was associated with no difference in risk for the composite end point (hazard ratio for inverse probability of treatment weighting, 0.92 [95% CI, 0.76-1.11]) but lower risk of all-cause mortality (hazard ratio for inverse probability of treatment weighting, 0.75 [95% CI, 0.59-0.95]). There was no significant relationship between metformin use and these end points in patients with prior heart failure or moderate to severe chronic kidney disease.
CONCLUSIONS


In a cohort of 12 156 patients with type 2 diabetes mellitus and high cardiovascular risk, metformin use was associated with lower rates of all-cause mortality, including after adjustment for clinical variables and biomarkers, but not lower rates of the composite end point of cardiovascular death, myocardial infarction, or ischemic stroke. This association was most apparent in patients without prior heart failure or moderate to severe chronic kidney disease.
CLINICAL TRIAL REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT01107886.",2019,"Metformin use was associated with no difference in risk for the composite end point (HRIPTW 0.92; 95% CI 0.76-1.11), but lower risk of all-cause mortality (HR IPTW  0.75; 95% CI 0.59-0.95).","['12,156 patients with baseline biomarker samples, 8,971 (74%) had metformin exposure, 1,611 (13%) had prior HF, and 1,332 (11', 'patients without prior HF or moderate to severe CKD', 'Patients with Diabetes with or without Heart Failure or Kidney Dysfunction', 'type 2 diabetes mellitus (T2DM', 'patients in SAVOR-TIMI 53 with baseline biomarker samples (n=12,156) were classified as Ever versus Never taking', '12,156 patients with T2DM and high CV risk']","['Metformin', 'metformin']","['CV death, myocardial infarction (MI), or ischemic stroke as well as CV death', 'CV death, MI, or ischemic stroke', 'inverse probability of treatment weighting (IPTW']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0151746', 'cui_str': 'Abnormal renal function (finding)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0439850', 'cui_str': 'Inverse (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.085248,"Metformin use was associated with no difference in risk for the composite end point (HRIPTW 0.92; 95% CI 0.76-1.11), but lower risk of all-cause mortality (HR IPTW  0.75; 95% CI 0.59-0.95).","[{'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Bergmark', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group (B.A.B., D.L.B., K.I., E.K., Y.G., E.B., B.M.S.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group (B.A.B., D.L.B., K.I., E.K., Y.G., E.B., B.M.S.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (D.K.M.).'}, {'ForeName': 'Avivit', 'Initials': 'A', 'LastName': 'Cahn', 'Affiliation': 'Diabetes Unit, Division of Internal Medicine, Hadassah Medical Center, Hebrew University of Jerusalem, The Faculty of Medicine, Israel (A.C., O.M., I.R.).'}, {'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Diabetes Unit, Division of Internal Medicine, Hadassah Medical Center, Hebrew University of Jerusalem, The Faculty of Medicine, Israel (A.C., O.M., I.R.).'}, {'ForeName': 'Ph Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'FACT (French Alliance for Cardiovascular Clinical Trials), Département Hospitalo-Universitaire FIRE (Fibrosis, Inflammation, Remodelling), Université de Paris, Sorbonne Paris-Cité, France (P.G.S.).'}, {'ForeName': 'KyungAh', 'Initials': 'K', 'LastName': 'Im', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group (B.A.B., D.L.B., K.I., E.K., Y.G., E.B., B.M.S.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Estella', 'Initials': 'E', 'LastName': 'Kanevsky', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group (B.A.B., D.L.B., K.I., E.K., Y.G., E.B., B.M.S.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Yared', 'Initials': 'Y', 'LastName': 'Gurmu', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group (B.A.B., D.L.B., K.I., E.K., Y.G., E.B., B.M.S.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Itamar', 'Initials': 'I', 'LastName': 'Raz', 'Affiliation': 'Diabetes Unit, Division of Internal Medicine, Hadassah Medical Center, Hebrew University of Jerusalem, The Faculty of Medicine, Israel (A.C., O.M., I.R.).'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group (B.A.B., D.L.B., K.I., E.K., Y.G., E.B., B.M.S.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Scirica', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group (B.A.B., D.L.B., K.I., E.K., Y.G., E.B., B.M.S.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.119.040144']
3358,32067293,A mindful yoga intervention for young women with major depressive disorder: Design and baseline sample characteristics of a randomized controlled trial.,"OBJECTIVES


Despite the gains made by current first-line interventions for major depressive disorder (MDD), modest rates of treatment response and high relapse indicate the need to augment existing interventions. Following theory and initial research indicating the promise of mindful yoga interventions (MYIs), this study examines mindful yoga as a treatment of MDD.
METHODS/DESIGN


This randomized controlled trial uses a sample of young females (18-34 years) to examine the efficacy and cost-effectiveness of a 9-week manualized MYI added to treatment as usual (TAU) versus TAU alone. Primary outcome measures consist of clinician-administered (Hamilton Depression Rating Scale) and self-report (Depression-Anxiety-Stress Scales) measures of depression. Underlying mechanisms will be examined, including rumination, negative self-evaluation, intolerance of uncertainty, interoceptive awareness, and dispositional mindfulness. Assessments were conducted at preintervention and will be conducted at postintervention, 6-, and 12-month follow up.
RESULTS


The baseline sample consists of 171 females (88 were randomized into the MYI), reporting a baseline M age  = 25.08 years (SD age  = 4.64), M Hamilton-depression  = 18.39 (SD Hamilton  = 6.00), and a M DASS-depression  = 21.02 (SD DASS  = 9.36).
CONCLUSION


This trial will provide important information regarding the benefits of adding yoga-based interventions to TAU for young women with MDD and the mechanisms through which such benefits may occur.",2020,"Underlying mechanisms will be examined, including rumination, negative self-evaluation, intolerance of uncertainty, interoceptive awareness, and dispositional mindfulness.","['171 females (88 were randomized into the MYI), reporting a baseline M age  = 25.08\u2009years (SD age  = 4.64', 'young women with major depressive disorder', 'young females (18-34\u2009years', 'young women with MDD']","['manualized MYI added to treatment as usual (TAU) versus TAU alone', 'mindful yoga intervention']","['clinician-administered (Hamilton Depression Rating Scale) and self-report (Depression-Anxiety-Stress Scales) measures of depression', 'efficacy and cost-effectiveness']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.134211,"Underlying mechanisms will be examined, including rumination, negative self-evaluation, intolerance of uncertainty, interoceptive awareness, and dispositional mindfulness.","[{'ForeName': 'Nina K', 'Initials': 'NK', 'LastName': 'Vollbehr', 'Affiliation': 'Lentis Psychiatric Institute, Center for Integrative Psychiatry, Groningen, Netherlands.'}, {'ForeName': 'H J Rogier', 'Initials': 'HJR', 'LastName': 'Hoenders', 'Affiliation': 'Lentis Psychiatric Institute, Center for Integrative Psychiatry, Groningen, Netherlands.'}, {'ForeName': 'Agna A', 'Initials': 'AA', 'LastName': 'Bartels-Velthuis', 'Affiliation': 'Lentis Psychiatric Institute, Center for Integrative Psychiatry, Groningen, Netherlands.'}, {'ForeName': 'Maaike H', 'Initials': 'MH', 'LastName': 'Nauta', 'Affiliation': 'Department of Clinical Psychology and Experimental Psychopathology, University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Stynke', 'Initials': 'S', 'LastName': 'Castelein', 'Affiliation': 'Lentis Psychiatric Institute, Center for Integrative Psychiatry, Groningen, Netherlands.'}, {'ForeName': 'Maya J', 'Initials': 'MJ', 'LastName': 'Schroevers', 'Affiliation': 'Faculty of Medical Sciences, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'A Dennis', 'Initials': 'AD', 'LastName': 'Stant', 'Affiliation': 'Zovon, Enschede, Netherlands.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'de Jong', 'Affiliation': 'Department of Clinical Psychology and Experimental Psychopathology, University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Ostafin', 'Affiliation': 'Department of Clinical Psychology and Experimental Psychopathology, University of Groningen, Groningen, Netherlands.'}]",International journal of methods in psychiatric research,['10.1002/mpr.1820']
3359,32062791,Phase 3 Multicenter Study of Revusiran in Patients with Hereditary Transthyretin-Mediated (hATTR) Amyloidosis with Cardiomyopathy (ENDEAVOUR).,"PURPOSE


The Phase 3 ENDEAVOUR study evaluated revusiran, an investigational RNA interference therapeutic targeting hepatic transthyretin (TTR) production, for treating cardiomyopathy caused by hereditary transthyretin-mediated (hATTR) amyloidosis.
METHODS


Patients with hATTR amyloidosis with cardiomyopathy were randomized 2:1 to receive subcutaneous daily revusiran 500 mg (n = 140) or placebo (n = 66) for 5 days over a week followed by weekly doses. Co-primary endpoints were 6-min walk test distance and serum TTR reduction.
RESULTS


Revusiran treatment was stopped after a median of 6.71 months; the study Sponsor prematurely discontinued dosing due to an observed mortality imbalance between treatment arms. Eighteen (12.9%) patients on revusiran and 2 (3.0%) on placebo died during the on-treatment period. Most deaths in both treatment arms were adjudicated as cardiovascular due to heart failure (HF), consistent with the natural history of the disease. A post hoc safety investigation of patients treated with revusiran found that, at baseline, a greater proportion of those who died were ≥ 75 years and showed clinical evidence of more advanced HF compared with those who were alive throughout treatment. Revusiran pharmacokinetic exposures and TTR lowering did not show meaningful differences between patients who died and who were alive. Revusiran did not deleteriously affect echocardiographic parameters, cardiac biomarkers, or frequency of cardiovascular and HF hospitalization events.
CONCLUSIONS


Causes for the observed mortality imbalance associated with revusiran were thoroughly investigated and no clear causative mechanism could be identified. Although the results suggest similar progression of cardiac parameters in both treatment arms, a role for revusiran cannot be excluded.
CLINICAL TRIAL REGISTRATION


NCT02319005.",2020,"Revusiran did not deleteriously affect echocardiographic parameters, cardiac biomarkers, or frequency of cardiovascular and HF hospitalization events.
","['Patients with hATTR amyloidosis with cardiomyopathy', 'Patients with Hereditary Transthyretin-Mediated (hATTR) Amyloidosis with Cardiomyopathy (ENDEAVOUR']","['Revusiran', 'subcutaneous daily revusiran 500\xa0mg (n\u2009=\u2009140) or placebo']","['6-min walk test distance and serum TTR reduction', 'echocardiographic parameters, cardiac biomarkers, or frequency of cardiovascular and HF hospitalization events', 'mortality imbalance', 'Revusiran pharmacokinetic exposures and TTR lowering']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002726', 'cui_str': 'Amyloidosis'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0439660', 'cui_str': 'Hereditary (qualifier value)'}, {'cui': 'C0032923', 'cui_str': 'Transthyretin'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}]","[{'cui': 'C4505592', 'cui_str': 'revusiran'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C4505592', 'cui_str': 'revusiran'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",,0.0976805,"Revusiran did not deleteriously affect echocardiographic parameters, cardiac biomarkers, or frequency of cardiovascular and HF hospitalization events.
","[{'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Judge', 'Affiliation': 'Johns Hopkins Hospital, Baltimore, MD, USA.'}, {'ForeName': 'Arnt V', 'Initials': 'AV', 'LastName': 'Kristen', 'Affiliation': 'Department of Cardiology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Grogan', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Mathew S', 'Initials': 'MS', 'LastName': 'Maurer', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Rodney H', 'Initials': 'RH', 'LastName': 'Falk', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Mazen', 'Initials': 'M', 'LastName': 'Hanna', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Gillmore', 'Affiliation': 'National Amyloidosis Centre, Division of Medicine, UCL Medical School Royal Free Hospital Rowland Hill Street, NW3 2PF, London, UK.'}, {'ForeName': 'Pushkal', 'Initials': 'P', 'LastName': 'Garg', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Akshay K', 'Initials': 'AK', 'LastName': 'Vaishnaw', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Harrop', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Powell', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Karsten', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Marianne T', 'Initials': 'MT', 'LastName': 'Sweetser', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Vest', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Philip N', 'Initials': 'PN', 'LastName': 'Hawkins', 'Affiliation': 'National Amyloidosis Centre, Division of Medicine, UCL Medical School Royal Free Hospital Rowland Hill Street, NW3 2PF, London, UK. p.hawkins@ucl.ac.uk.'}]",Cardiovascular drugs and therapy,['10.1007/s10557-019-06919-4']
3360,30961875,The effect of the Preparing Pequeños small-group cognitive instruction program on academic and concurrent social and behavioral outcomes in young Spanish-speaking dual-language learners.,"Academic achievement for young dual language learners (DLL) is a critically acknowledged problem of national significance that has been understudied. To address this shortage, this study evaluated the effectiveness of Preparing Pequeños, an integrated small-group instruction program designed to promote increased learning for Spanish speaking DLL in language, literacy, and math. The DLL in the randomized Preparing Pequeños intervention classrooms were compared to control DLL with comparable Spanish language delays and in which the school district's core curriculum was being implemented. Intervention teachers and paraprofessionals, as part of Preparing Pequeños, implemented new classroom and time management systems in order to conduct 90 min of small-group instruction four days each week across the school year. In total, 51 control and 52 intervention classrooms participated; pre-test measures were completed with 829 children, with 777 of these children also completing post-test measures (7% attrition). Results showed that intervention teachers and paraprofessionals, as compared to control, showed greater increases in most of the targeted areas of cognitive instruction (d range = 0.60-2.38) and in the use of small groups (d range = 3.32-4.46), progress monitoring (d = 0.17) to inform instruction, and team teaching (d = 1.94). Intervention children, as compared to control, showed significantly greater gains in Spanish oral language, print knowledge, phonological awareness, and phonics with small to large effect sizes (d range = 0.14-0.52). Also, potentially as a result of greater attention to children's individual needs and support for managing their behavior, intervention children, as compared to control, showed greater decreases in school avoidance, anger, and aggression with small effect sizes (d range = -0.22 to -0.29). Results are discussed in relation to the need for greater attention in teachers' training in effective approaches for small-group instruction.",2019,"Intervention children, as compared to control, showed significantly greater gains in Spanish oral language, print knowledge, phonological awareness, and phonics with small to large effect sizes (d range = 0.14-0.52).","['young dual language learners (DLL', 'young Spanish-speaking dual-language learners']",['Preparing Pequeños small-group cognitive instruction program'],"['school avoidance, anger, and aggression with small effect sizes', 'targeted areas of cognitive instruction', 'gains in Spanish oral language, print knowledge, phonological awareness, and phonics with small to large effect sizes']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}]","[{'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]",,0.012336,"Intervention children, as compared to control, showed significantly greater gains in Spanish oral language, print knowledge, phonological awareness, and phonics with small to large effect sizes (d range = 0.14-0.52).","[{'ForeName': 'Susan H', 'Initials': 'SH', 'LastName': 'Landry', 'Affiliation': ""University of Texas Health Science Center at Houston, Department of Pediatrics, Children's Learning Institute, 7000 Fannin, Ste. 2300, Houston, TX 77030, United States of America. Electronic address: Susan.Landry@uth.tmc.edu.""}, {'ForeName': 'Mike A', 'Initials': 'MA', 'LastName': 'Assel', 'Affiliation': ""University of Texas Health Science Center at Houston, Department of Pediatrics, Children's Learning Institute, 7000 Fannin, Ste. 2300, Houston, TX 77030, United States of America. Electronic address: Michael.A.Assel@uth.tmc.edu.""}, {'ForeName': 'María S', 'Initials': 'MS', 'LastName': 'Carlo', 'Affiliation': ""University of Texas Health Science Center at Houston, Department of Pediatrics, Children's Learning Institute, 7000 Fannin, Ste. 2300, Houston, TX 77030, United States of America. Electronic address: mariacarlo@usf.edu.""}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Williams', 'Affiliation': ""University of Texas Health Science Center at Houston, Department of Pediatrics, Children's Learning Institute, 7000 Fannin, Ste. 2300, Houston, TX 77030, United States of America. Electronic address: Jwilliams32@usf.edu.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': ""University of Texas Health Science Center at Houston, Department of Pediatrics, Children's Learning Institute, 7000 Fannin, Ste. 2300, Houston, TX 77030, United States of America. Electronic address: wei.wu@uth.tmc.edu.""}, {'ForeName': 'Janelle J', 'Initials': 'JJ', 'LastName': 'Montroy', 'Affiliation': ""University of Texas Health Science Center at Houston, Department of Pediatrics, Children's Learning Institute, 7000 Fannin, Ste. 2300, Houston, TX 77030, United States of America. Electronic address: Janelle.j.montroy@uth.tmc.edu.""}]",Journal of school psychology,['10.1016/j.jsp.2019.01.001']
3361,31364474,Feasibility and efficacy of a web-based family telehealth nutrition intervention to improve child weight status and dietary intake: A pilot randomised controlled trial.,"INTRODUCTION


Innovative eHealth solutions that improve access to child weight management interventions are crucial to address the rising prevalence of childhood obesity globally. The study aimed to evaluate the feasibility and preliminary efficacy of a 12-week online telehealth nutrition intervention to improve child weight and dietary outcomes, and the impact of additional text messages (SMS) targeted to mothers and fathers.
METHODS


Families with children aged 4 to 11 were randomised across three groups: Telehealth, Telehealth+SMS, or Waitlist control. Telehealth and Telehealth+SMS groups received two telehealth consultations delivered by a dietitian, 12 weeks access to a nutrition website and a private Facebook group. The Telehealth+SMS group received additional SMS. Feasibility was assessed through recruitment, retention, and intervention utilisation. Efficacy was assessed through changes in measured child body mass index (BMI), waist circumference and diet.
RESULTS


Forty-four (96%) and 36 (78%) families attended initial and second telehealth consultations, respectively. Thirty-six families (78%) completed week 12 assessments. Child BMI and waist circumference changes from baseline to week 12 were not statistically different within or between groups. Children in Telehealth+SMS had significantly reduced percentage energy from energy-dense nutrient-poor food (95% CI -21.99 to -0.03%E;  p  = .038) and increased percentage energy from healthy core food (95% CI -0.21 to 21.89%E;  p  = .045) compared to Waitlist control.
DISCUSSION


A family-focused online telehealth nutrition intervention is feasible. While the modest sample size reduced power to detect between-group changes in weight status, some improvements in child dietary intakes were identified in those receiving telehealth and SMS.",2019,,[],['web-based family telehealth nutrition intervention'],"['Feasibility and efficacy', 'child weight status and dietary intake']",[],"[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}]",,0.0748469,,"[{'ForeName': 'Li Kheng', 'Initials': 'LK', 'LastName': 'Chai', 'Affiliation': 'School of Health Sciences, Faculty of Health and Medicine, The University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Clare E', 'Initials': 'CE', 'LastName': 'Collins', 'Affiliation': 'School of Health Sciences, Faculty of Health and Medicine, The University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'May', 'Affiliation': 'School of Health Sciences, Faculty of Health and Medicine, The University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Ashman', 'Affiliation': 'School of Health Sciences, Faculty of Health and Medicine, The University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Holder', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, Australia.'}, {'ForeName': 'Leanne J', 'Initials': 'LJ', 'LastName': 'Brown', 'Affiliation': 'University of Newcastle Department of Rural Health, The University of Newcastle, North Tamworth Australia.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Burrows', 'Affiliation': 'School of Health Sciences, Faculty of Health and Medicine, The University of Newcastle, Callaghan, Australia.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19865855']
3362,32044942,Effect of Incisional Negative Pressure Wound Therapy vs Standard Wound Dressing on Deep Surgical Site Infection After Surgery for Lower Limb Fractures Associated With Major Trauma: The WHIST Randomized Clinical Trial.,"Importance


Following surgery to treat major trauma-related fractures, deep wound infection rates are high. It is not known if negative pressure wound therapy can reduce infection rates in this setting.
Objective


To assess outcomes in patients who have incisions resulting from surgery for lower limb fractures related to major trauma and were treated with either incisional negative pressure wound therapy or standard wound dressing.
Design, Setting, and Participants


A randomized clinical trial conducted at 24 trauma hospitals representing the UK Major Trauma Network that included 1548 patients aged 16 years or older who underwent surgery for a lower limb fracture caused by major trauma from July 7, 2016, through April 17, 2018, with follow-up to December 11, 2018.
Interventions


Incisional negative pressure wound therapy (n = 785), which involved a specialized dressing used to create negative pressure over the wound, vs standard wound dressing not involving negative pressure (n = 763).
Main Outcomes and Measures


The primary outcome measure was deep surgical site infection at 30 days diagnosed according to the criteria from the US Centers for Disease Control and Prevention. A preplanned secondary analysis of the primary outcome was performed at 90 days. The secondary outcomes were patient-reported disability (Disability Rating Index), health-related quality of life (EuroQol 5-level EQ-5D), surgical scar assessment (Patient and Observer Scar Assessment Scale), and chronic pain (Douleur Neuropathique Questionnaire) at 3 and 6 months, as well as other local wound healing complications at 30 days.
Results


Among 1548 participants who were randomized (mean [SD] age, 49.8 [20.3] years; 561 [36%] were aged ≤40 years; 583 [38%] women; and 881 [57%] had multiple injuries), 1519 (98%) had data available for the primary outcome. At 30 days, deep surgical site infection occurred in 5.84% (45 of 770 patients) of the incisional negative pressure wound therapy group and in 6.68% (50 of 749 patients) of the standard wound dressing group (odds ratio, 0.87 [95% CI, 0.57 to 1.33]; absolute risk difference, -0.77% [95% CI, -3.19% to 1.66%]; P = .52). There was no significant difference in the deep surgical site infection rate at 90 days (11.4% [72 of 629 patients] in the incisional negative pressure wound therapy group vs 13.2% [78 of 590 patients] in the standard wound dressing group; odds ratio, 0.84 [95% CI, 0.59 to 1.19]; absolute risk difference, -1.76% [95% CI, -5.41% to 1.90%]; P = .32). For the 5 prespecified secondary outcomes reported, there were no significant differences at any time point.
Conclusions and Relevance


Among patients who underwent surgery for major trauma-related lower limb fractures, use of incisional negative pressure wound therapy, compared with standard wound dressing, resulted in no significant difference in the rate of deep surgical site infection. The findings do not support the use of incisional negative pressure wound therapy in this setting, although the event rate at 30 days was lower than expected.
Trial Registration


isrctn.org Identifier: ISRCTN12702354.",2020,"At 30 days, deep surgical site infection occurred in 5.84% (45 of 770 patients) of the incisional negative pressure wound therapy group and in 6.68% (50 of 749 patients) of the standard wound dressing group (odds ratio, 0.87 [95% CI, 0.57 to 1.33]; absolute risk difference, -0.77% [95% CI, -3.19% to 1.66%]; P = .52).","['1548 participants who were randomized (mean [SD] age, 49.8 [20.3] years; 561 [36%] were aged ≤40 years; 583 [38%] women; and 881 [57%] had multiple injuries), 1519 (98%) had data available for the primary outcome', 'patients who underwent surgery for major trauma-related lower limb fractures', 'Major Trauma', 'patients who have incisions resulting from surgery for lower limb fractures related to major trauma and were treated with either', 'Lower Limb Fractures', '24 trauma hospitals representing the UK Major Trauma Network that included 1548 patients aged 16 years or older who underwent surgery for a lower limb fracture caused by major trauma from July 7, 2016, through April 17, 2018, with follow-up to December 11, 2018']","['Incisional Negative Pressure Wound Therapy vs Standard Wound Dressing', 'incisional negative pressure wound therapy or standard wound dressing', 'Incisional negative pressure wound therapy (n\u2009=\u2009785), which involved a specialized dressing used to create negative pressure over the wound, vs standard wound dressing not involving negative pressure']","['patient-reported disability (Disability Rating Index), health-related quality of life (EuroQol 5-level EQ-5D), surgical scar assessment (Patient and Observer Scar Assessment Scale), and chronic pain (Douleur Neuropathique Questionnaire) at 3 and 6 months, as well as other local wound healing complications', 'Deep Surgical Site Infection', 'deep surgical site infection rate', 'infection rates', 'deep surgical site infection', 'rate of deep surgical site infection']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0026771', 'cui_str': 'Polytrauma'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1542178', 'cui_str': 'Fracture of lower leg'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178388', 'cui_str': 'Dressing of wound (procedure)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0205429', 'cui_str': 'Uninvolved (qualifier value)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0334150', 'cui_str': 'Surgical scar (morphologic abnormality)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",1548.0,0.156034,"At 30 days, deep surgical site infection occurred in 5.84% (45 of 770 patients) of the incisional negative pressure wound therapy group and in 6.68% (50 of 749 patients) of the standard wound dressing group (odds ratio, 0.87 [95% CI, 0.57 to 1.33]; absolute risk difference, -0.77% [95% CI, -3.19% to 1.66%]; P = .52).","[{'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Costa', 'Affiliation': 'Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford, England.'}, {'ForeName': 'Juul', 'Initials': 'J', 'LastName': 'Achten', 'Affiliation': 'Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford, England.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Knight', 'Affiliation': 'Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford, England.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bruce', 'Affiliation': 'Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, England.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Dutton', 'Affiliation': 'Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford, England.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Madan', 'Affiliation': 'Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, England.'}, {'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Dritsaki', 'Affiliation': 'Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford, England.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Parsons', 'Affiliation': 'Statistics and Epidemiology Unit, Warwick Medical School, University of Warwick, Coventry, England.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Fernandez', 'Affiliation': 'Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford, England.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Grant', 'Affiliation': 'Nuneaton, England.'}, {'ForeName': 'Jagdeep', 'Initials': 'J', 'LastName': 'Nanchahal', 'Affiliation': 'Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford, England.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.0059']
3363,32067261,"Brief Cognitive-based Psychosocial Intervention and Case Management for Suicide Attempters Discharged from the Emergency Department in Taipei, Taiwan: A Randomized Controlled Study.","OBJECTIVE


We examined the effectiveness of brief cognitive-based psychotherapy plus standard case management in the prevention of further suicide attempts, clinical severity, and treatment adherence in a randomized clinical trial compared with standard case management.
METHOD


Among five hundred and ninety-seven patients presenting with suicide attempts, 147 participants were included. They were randomized into two groups. After a 6-session intervention over four months, all participants were re-evaluated at the 6th and 12th months.
RESULTS


At a 6-month assessment, the intervention had approximately halved the odds of following suicide attempts and doubled the odds of outpatient visits in comparison with standard case management, although the differences did not attain statistical significance. At a 12-month assessment, the two groups did not differ significantly in any of the outcome variables. Generalized linear mixed models indicated that intervention did not significantly decrease the subsequent suicide risk and severity of clinical symptoms, but it did increase psychiatric outpatient treatment adherence. The subgroup analysis revealed that the intervention increased the outpatient clinic visits only for repetitive attempters, not for first-time attempters.
CONCLUSIONS


Further studies are needed to test whether more intensive psychotherapy sessions might be more effective in decreasing the probability of further attempt and the severity of symptoms.",2020,"The subgroup analysis revealed that the intervention increased the outpatient clinic visits only for repetitive attempters, not for first-time attempters.
","['five hundred and ninety-seven patients presenting with suicide attempts, 147 participants were included', 'Suicide Attempters']","['brief cognitive-based psychotherapy plus standard case management', 'Brief Cognitive-based Psychosocial Intervention and Case Management']","['psychiatric outpatient treatment adherence', 'outpatient clinic visits', 'subsequent suicide risk and severity of clinical symptoms']","[{'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0439073', 'cui_str': '97 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt (event)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0085971', 'cui_str': 'Case Management'}]","[{'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C4505265', 'cui_str': 'Treatment Adherence'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0563664', 'cui_str': 'Suicide risk'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",597.0,0.0364275,"The subgroup analysis revealed that the intervention increased the outpatient clinic visits only for repetitive attempters, not for first-time attempters.
","[{'ForeName': 'Yi-Chun', 'Initials': 'YC', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry, Mackay Memorial Hospital, Hsinchu, Taiwan.'}, {'ForeName': 'Shen-Ing', 'Initials': 'SI', 'LastName': 'Liu', 'Affiliation': 'Department of Psychiatry, Mackay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Shu-Chin', 'Initials': 'SC', 'LastName': 'Chen', 'Affiliation': 'Center of Suicide Prevention, Mackay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Fang-Ju', 'Initials': 'FJ', 'LastName': 'Sun', 'Affiliation': 'Department of Medical Research, Mackay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Hui-Chun', 'Initials': 'HC', 'LastName': 'Huang', 'Affiliation': 'Department of Medical Research, Mackay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chiu-Ron', 'Initials': 'CR', 'LastName': 'Huang', 'Affiliation': 'Department of Medical Research, Mackay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Yu-Chuan', 'Initials': 'YC', 'LastName': 'Chiu', 'Affiliation': 'Department of Psychiatry, Mackay Memorial Hospital, Taipei, Taiwan.'}]",Suicide & life-threatening behavior,['10.1111/sltb.12626']
3364,32049937,"Weekly Teriparatide Versus Bisphosphonate for Bone Union During 6 Months After Multi-Level Lumbar Interbody Fusion for Osteoporotic Patients: A Multicenter, Prospective, Randomized Study.","STUDY DESIGN


Multicenter, prospective randomized study.
OBJECTIVE


Evaluate the impact of weekly teriparatide (WT) and bone contact (BC) status of grafted bone in patients recovering from multilevel lumbar interbody fusion (M-LIF).
SUMMARY OF BACKGROUND DATA


WT has been reported to significantly improve bone fusion following posterior or transforaminal interbody fusion in osteoporosis patients.
METHODS


Patients older than 50 years and osteoporotic were recruited. We defined the fusion of two or more consecutive intervertebral levels as M-LIF. All patients were instrumented with pedicle, iliac, or S-2 alar iliac screws after transplanting cages and autogenous bone between vertebral bodies. After surgical indication for M-LIF, the subjects were randomly allocated to receive either subcutaneous WT from 1 week to 6 months postoperatively (WT arm, N = 50) or a bisphosphonate (BP; BP arm, N = 54). Blinded radiological evaluations were performed using computed tomography (CT). Evaluation of bone fusion was performed at the intervertebral disc located at the bottom of the fixed range. The degree of bone fusion was calculated as a score from 2 to 6 points, with 2 defined as complete fusion. Bone fusion rate was also compared at 6 months postoperatively based on BC status of the grafted bone on CT immediately after surgery.
RESULTS


Mean bone fusion score at 6 months postoperatively was 3.9 points in the WT group and 4.2 points in the BP group. The bone fusion rate at 6 months postoperatively tended to be higher in the WT group (46.8% vs. 32.7% in the BP group). The 6-month postoperative fusion rate of immediately postoperative of BC+ patients was significantly higher than that of BC- patients (47.4% vs. 9.5%).
CONCLUSION


In M-LIF, there were no significant differences in bone fusion score between WT- and BP-treated patients. In contrast, BC status immediately postoperatively had a major impact on 6-month bone fusion.
LEVEL OF EVIDENCE


1.",2020,"The 6-month postoperative fusion rate of immediately postoperative of BC+ patients was significantly higher than that of BC- patients (47.4% vs. 9.5%).
","['Osteoporotic Patients', 'patients recovering from multi-level lumbar interbody fusion (M-LIF', 'All patients were instrumented with pedicle, iliac, or S-2 alar iliac screws after transplanting cages and autogenous bone between vertebral bodies', 'Patients older than 50 years and osteoporotic were recruited']","['teriparatide (WT) and bone contact (BC) status of grafted bone', 'Teriparatide versus Bisphosphonate', 'bisphosphonate', 'subcutaneous WT', 'BC']","['bone fusion rate', '6-month postoperative fusion rate of immediately postoperative of BC+ patients', 'Mean bone fusion score', 'degree of bone fusion', 'bone fusion score', 'Bone fusion rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521108', 'cui_str': 'Recovering from (contextual qualifier) (qualifier value)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0456605', 'cui_str': 'Pedicle (substance)'}, {'cui': 'C2722359', 'cui_str': 'S-2'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0337189', 'cui_str': 'Cage, device (physical object)'}, {'cui': 'C0443145', 'cui_str': 'Autogenous (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0223084', 'cui_str': 'Structure of body of vertebra'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonates'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C0185364', 'cui_str': 'Repair or plastic operation on bone'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}]",,0.037528,"The 6-month postoperative fusion rate of immediately postoperative of BC+ patients was significantly higher than that of BC- patients (47.4% vs. 9.5%).
","[{'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Oba', 'Affiliation': 'Department of Orthopaedic Surgery, Shinshu University School of Medicine, Nagano, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Takahashi', 'Affiliation': 'Department of Orthopaedic Surgery, Shinshu University School of Medicine, Nagano, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yokomichi', 'Affiliation': 'Department of Health Sciences, University of Yamanashi School of Medicine, Yamanashi, Japan.'}, {'ForeName': 'Tomohiko', 'Initials': 'T', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Orthopaedic Surgery, Hamamatsu University School of Medicine, Shizuoka, Japan.'}, {'ForeName': 'Shigeto', 'Initials': 'S', 'LastName': 'Ebata', 'Affiliation': 'Department of Orthopaedic Surgery, University of Yamanashi School of Medicine, Yamanashi, Japan.'}, {'ForeName': 'Keijiro', 'Initials': 'K', 'LastName': 'Mukaiyama', 'Affiliation': 'Department of Orthopaedic Surgery, North Alps Medical Center Azumi Hospital, Nagano, Japan.'}, {'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Ohba', 'Affiliation': 'Department of Orthopaedic Surgery, University of Yamanashi School of Medicine, Yamanashi, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Ushirozako', 'Affiliation': 'Department of Orthopaedic Surgery, Hamamatsu University School of Medicine, Shizuoka, Japan.'}, {'ForeName': 'Shugo', 'Initials': 'S', 'LastName': 'Kuraishi', 'Affiliation': 'Department of Orthopaedic Surgery, Shinshu University School of Medicine, Nagano, Japan.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Ikegami', 'Affiliation': 'Department of Orthopaedic Surgery, Shinshu University School of Medicine, Nagano, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Uehara', 'Affiliation': 'Department of Orthopaedic Surgery, Shinshu University School of Medicine, Nagano, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Takizawa', 'Affiliation': 'Department of Orthopaedic Surgery, Shinshu University School of Medicine, Nagano, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Munakata', 'Affiliation': 'Department of Orthopaedic Surgery, Shinshu University School of Medicine, Nagano, Japan.'}, {'ForeName': 'Terue', 'Initials': 'T', 'LastName': 'Hatakenaka', 'Affiliation': 'Department of Orthopaedic Surgery, Shinshu University School of Medicine, Nagano, Japan.'}, {'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Matsuyama', 'Affiliation': 'Department of Orthopaedic Surgery, Hamamatsu University School of Medicine, Shizuoka, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Haro', 'Affiliation': 'Department of Orthopaedic Surgery, University of Yamanashi School of Medicine, Yamanashi, Japan.'}]",Spine,['10.1097/BRS.0000000000003426']
3365,31968351,"5-Year Survival after Endobronchial Coil Implantation: Secondary Analysis of the First Randomised Controlled Trial, RESET.","BACKGROUND


Lung volume reduction surgery is a proven treatment for emphysematous patients with hyperinflation, but the precarious health of candidates has prompted development of less invasive approaches. Bronchoscopic implanted endobronchial coils, shape-memory nitinol filaments, shrink emphysematous lung tissue to restore elastic recoil and to tether airways to maintain patency. Studies have demonstrated an acceptable safety profile and improvements in lung function, exercise capacity, and quality of life out to 3 years. Volume reduction is key. However, data for longer-term survival are limited.
OBJECTIVE


The aim of this study was to establish the 5-year overall and transplant-free survivals of subjects whose procedure in the first randomized controlled trial, RESET, achieved clinically meaningful reduction in residual volume (RV).
METHODS


Patients and their primary care doctors were contacted to confirm vital status and history of additional interventions. Death certificates were acquired via the General Registry Office. Survival time was calculated for responders achieving a reduction of ≥10% in RV compared to non-responders.
RESULTS


39 patients completed the planned bilateral sequential treatments. Six patients received unilateral implants. At 5 years, 22 patients had died. The overall survivals at 1, 2, 3, 4 and 5 years were 88.9, 88.9, 77.8, 64.4 and 50.6%, respectively. Two patients underwent lung transplantation at 52 and 59 months and were alive at 5 years. The transplant-free (TF) survivals at 1, 2, 3, 4 and 5 years were 88.9, 88.9, 77.8, 64.4 and 46.7%, respectively. Volume reduction responders (n = 18) at 3 months had a 5-year TF survival of 66.7% compared to 36.4% for non-responders (n = 22; p = 0.07). Higher baseline inspiratory capacity (HR 0.13, 95% CI 0.02-0.73; p = 0.02) and partial pressure of oxygen (pO2) (HR 0.57, 95% CI 0.38-0.86; p < 0.01) values were predictive of survival for the entire cohort and were not influenced by age.
CONCLUSIONS


Endobronchial coil implantation appears to confer a 5-year survival advantage for those who achieved a 10% reduction in RV at 3 months. Ongoing trials are designed to clarify the mechanisms of action of coils and to refine patient selection.",2020,Volume reduction responders (n = 18) at 3 months had a 5-year TF survival of 66.7% compared to 36.4% for non-responders (n = 22; p = 0.07).,"['Patients and their primary care doctors', '39 patients completed the planned bilateral sequential treatments', 'emphysematous patients with hyperinflation']","['unilateral implants', 'Endobronchial Coil Implantation', 'Endobronchial coil implantation']","['partial pressure of oxygen (pO2', '5-Year Survival', 'lung function, exercise capacity, and quality of life', 'transplant-free (TF) survivals', '5-year TF survival', '5-year overall and transplant-free survivals', 'died', 'overall survivals', '5-year survival advantage', 'residual volume (RV', 'Survival time', 'Higher baseline inspiratory capacity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0333159', 'cui_str': 'Emphysematous (qualifier value)'}, {'cui': 'C0020449', 'cui_str': 'Hyperdistention (morphologic abnormality)'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0444471', 'cui_str': 'Endobronchial (qualifier value)'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil (physical object)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1283004', 'cui_str': 'PO>2< measurement (procedure)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034380'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume (observable entity)'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0021610', 'cui_str': 'Inspiratory Capacity'}]",,0.0670127,Volume reduction responders (n = 18) at 3 months had a 5-year TF survival of 66.7% compared to 36.4% for non-responders (n = 22; p = 0.07).,"[{'ForeName': 'Justin L', 'Initials': 'JL', 'LastName': 'Garner', 'Affiliation': 'Royal Brompton Hospital, London, United Kingdom, J.Garner@rbht.nhs.uk.'}, {'ForeName': 'Samuel V', 'Initials': 'SV', 'LastName': 'Kemp', 'Affiliation': 'Royal Brompton Hospital, London, United Kingdom.'}, {'ForeName': 'Karthi', 'Initials': 'K', 'LastName': 'Srikanthan', 'Affiliation': 'Royal Brompton Hospital, London, United Kingdom.'}, {'ForeName': 'Cielito', 'Initials': 'C', 'LastName': 'Caneja', 'Affiliation': 'Royal Brompton Hospital, London, United Kingdom.'}, {'ForeName': 'Zaid', 'Initials': 'Z', 'LastName': 'Zoumot', 'Affiliation': 'Respiratory Institute, Cleveland Clinic Abu Dhabi, Abu Dhabi, United Arab Emirates.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Roberts', 'Affiliation': 'Royal Brompton Hospital, London, United Kingdom.'}, {'ForeName': 'Winston', 'Initials': 'W', 'LastName': 'Banya', 'Affiliation': 'Royal Brompton Hospital, London, United Kingdom.'}, {'ForeName': 'Rekha', 'Initials': 'R', 'LastName': 'Chaudhuri', 'Affiliation': 'Gartnavel General Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bicknell', 'Affiliation': 'Gartnavel General Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Ewen', 'Initials': 'E', 'LastName': 'Ross', 'Affiliation': 'Gartnavel General Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Adam S', 'Initials': 'AS', 'LastName': 'LaPrad', 'Affiliation': 'PneumRx, Inc., a BTG International Group Company, Santa Clara, California, USA.'}, {'ForeName': 'Pallav L', 'Initials': 'PL', 'LastName': 'Shah', 'Affiliation': 'Royal Brompton Hospital, London, United Kingdom.'}]",Respiration; international review of thoracic diseases,['10.1159/000505274']
3366,31359053,Cost-effectiveness of an Environmental Cleaning Bundle for Reducing Healthcare-associated Infections.,"BACKGROUND


Healthcare-associated infections (HAIs) remain a significant patient safety issue, with point prevalence estimates being ~5% in high-income countries. In 2016-2017, the Researching Effective Approaches to Cleaning in Hospitals (REACH) study implemented an environmental cleaning bundle targeting communication, staff training, improved cleaning technique, product use, and audit of frequent touch-point cleaning. This study evaluates the cost-effectiveness of the environmental cleaning bundle for reducing the incidence of HAIs.
METHODS


A stepped-wedge, cluster-randomized trial was conducted in 11 hospitals recruited from 6 Australian states and territories. Bundle effectiveness was measured by the numbers of Staphylococcus aureus bacteremia, Clostridium difficile infection, and vancomycin-resistant enterococci infections prevented in the intervention phase based on estimated reductions in the relative risk of infection. Changes to costs were defined as the cost of implementing the bundle minus cost savings from fewer infections. Health benefits gained from fewer infections were measured in quality-adjusted life-years (QALYs). Cost-effectiveness was evaluated using the incremental cost-effectiveness ratio and net monetary benefit of adopting the cleaning bundle over existing hospital cleaning practices.
RESULTS


Implementing the cleaning bundle cost $349 000 Australian dollars (AUD) and generated AUD$147 500 in cost savings. Infections prevented under the cleaning bundle returned a net monetary benefit of AUD$1.02 million and an incremental cost-effectiveness ratio of $4684 per QALY gained. There was an 86% chance that the bundle was cost-effective compared with existing hospital cleaning practices.
CONCLUSIONS


A bundled, evidence-based approach to improving hospital cleaning is a cost-effective intervention for reducing the incidence of HAIs.",2020,"Bundle effectiveness was measured by the numbers of Staphylococcus aureus bacteremia (SAB), Clostridium difficile infection (CDI) and vancomycin-resistant enterococci (VRE) infections prevented in the intervention phase, based on estimated reductions in the relative risk of infection.",['eleven hospitals recruited from six Australian states and territories'],['environmental cleaning bundle'],"['Cost-effectiveness', 'numbers of Staphylococcus aureus bacteremia (SAB), Clostridium difficile infection (CDI) and vancomycin-resistant enterococci (VRE) infections', 'incremental cost-effectiveness ratio', 'cost-effectiveness', 'Bundle effectiveness']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1301808', 'cui_str': 'State'}]",[],"[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1142423', 'cui_str': 'Bacteremia caused by Staphylococcus aureus'}, {'cui': 'C0343386', 'cui_str': 'Clostridium difficile infection (disorder)'}, {'cui': 'C1265175', 'cui_str': 'Vancomycin-Resistant Enterococci'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",,0.0429117,"Bundle effectiveness was measured by the numbers of Staphylococcus aureus bacteremia (SAB), Clostridium difficile infection (CDI) and vancomycin-resistant enterococci (VRE) infections prevented in the intervention phase, based on estimated reductions in the relative risk of infection.","[{'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'White', 'Affiliation': 'Australian Centre for Health Services Innovation, Institute of Health and Biomedical Innovation, Brisbane, Queensland, Western Australia.'}, {'ForeName': 'Adrian G', 'Initials': 'AG', 'LastName': 'Barnett', 'Affiliation': 'Australian Centre for Health Services Innovation, Institute of Health and Biomedical Innovation, Brisbane, Queensland, Western Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Hall', 'Affiliation': 'School of Public Healt, New South Wales,h and Social Work, Queensland University of Technology, Brisbane, Western Australia.'}, {'ForeName': 'Brett G', 'Initials': 'BG', 'LastName': 'Mitchell', 'Affiliation': 'Discipline of Nursing, Avondale College of Higher Education, Wahroonga, New South Wales, Western Australia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Farrington', 'Affiliation': 'Australian Centre for Health Services Innovation, Institute of Health and Biomedical Innovation, Brisbane, Queensland, Western Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Halton', 'Affiliation': 'School of Public Healt, New South Wales,h and Social Work, Queensland University of Technology, Brisbane, Western Australia.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Paterson', 'Affiliation': ""University of Queensland Centre for Clinical Research, Royal Brisbane and Women's Hospital, Crawley, Western Australia.""}, {'ForeName': 'Thomas V', 'Initials': 'TV', 'LastName': 'Riley', 'Affiliation': 'School of Biomedical Sciences, The University of Western Australia, Crawley, Western Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Gardner', 'Affiliation': 'School of Public Healt, New South Wales,h and Social Work, Queensland University of Technology, Brisbane, Western Australia.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Page', 'Affiliation': 'School of Public Healt, New South Wales,h and Social Work, Queensland University of Technology, Brisbane, Western Australia.'}, {'ForeName': 'Christian A', 'Initials': 'CA', 'LastName': 'Gericke', 'Affiliation': 'School of Clinical Medicine, University of Queensland, Cairns, Queensland, Brisbane, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Graves', 'Affiliation': 'Australian Centre for Health Services Innovation, Institute of Health and Biomedical Innovation, Brisbane, Queensland, Western Australia.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz717']
3367,31711969,A Stepped-Wedge Randomized Controlled Trial: Effects of eHealth Interventions for Pain Control Among Adults With Cancer in Hospice.,"CONTEXT


Unrelieved cancer pain at the end of life interferes with achieving patient-centered goals.
OBJECTIVE


To compare effects of usual hospice care and PAINRelieveIt® on pain outcomes in patients and their lay caregivers.
METHODS


In a five-step, stepped-wedge randomized, controlled study, 234 patients (49% male, 18% Hispanic, 51% racial minorities) and 231 lay caregivers (26% male, 20% Hispanic, 54% racial minorities) completed pre-pain/post-pain measures. They received usual hospice care with intervention components that included a summary of the patient's pain data, decision support for hospice nurses, and multimedia education tailored to the patient's and lay caregiver's misconceptions about pain.
RESULTS


The intervention effect on analgesic adherence (primary outcome) was not significant. Post-test worst pain intensity was significantly higher for the experimental group, but the difference (0.70; CI = [0.12, 1.27]) was not clinically meaningful. There was nearly universal availability of prescriptions for strong opioids and adjuvant analgesics for neuropathic pain in both groups. Lay caregivers' pain misconceptions (0-5 scale) were significantly lower in the experimental group than the usual care group (mean difference controlling for baseline is 0.38; CI = [0.08, 0.67]; P = 0.01).
CONCLUSION


This randomized controlled trial was a negative trial for the primary study outcomes but positive for a secondary outcome. The trial is important for clearly demonstrating the feasibility of implementing the innovative set of interventions.",2020,"Lay caregivers' pain misconceptions (0-5 scale) were significantly lower in the experimental group compared to the usual care group (mean difference controlling for baseline is 0.38; CI=[0.08, 0.67]; p=.01).
","['234 patients (49% male, 18% Hispanic, 51% racial minorities) and 231 lay caregivers (26% male, 20% Hispanic, 54% racial minorities', 'Adults with Cancer in Hospice', 'patients and their lay caregivers']","[""usual hospice care with intervention components that included a summary of the patient's pain data, decision support for hospice nurses, and multimedia education tailored to the patient's and lay caregiver's misconceptions about pain"", 'usual hospice care and PAINRelieveIt®', 'eHealth Interventions']","['analgesic adherence', 'pain outcomes', 'neuropathic pain', ""Lay caregivers' pain misconceptions"", 'Posttest worst pain intensity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0600261', 'cui_str': 'Lying'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0019947', 'cui_str': 'Hospices'}]","[{'cui': 'C0085555', 'cui_str': 'Hospice Care'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0019947', 'cui_str': 'Hospices'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0600261', 'cui_str': 'Lying'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027796', 'cui_str': 'Neurodynia'}, {'cui': 'C0600261', 'cui_str': 'Lying'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",234.0,0.251735,"Lay caregivers' pain misconceptions (0-5 scale) were significantly lower in the experimental group compared to the usual care group (mean difference controlling for baseline is 0.38; CI=[0.08, 0.67]; p=.01).
","[{'ForeName': 'Diana J', 'Initials': 'DJ', 'LastName': 'Wilkie', 'Affiliation': 'Department of Biobehavioral Nursing Science, College of Nursing, University of Florida, Gainesville, Florida, USA; University of Illinois at Chicago, Center for Palliative Care Research & Education (CPCRE), Chicago, Illinois, USA. Electronic address: diwilkie@ufl.edu.'}, {'ForeName': 'Yingwei', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Department of Biobehavioral Nursing Science, College of Nursing, University of Florida, Gainesville, Florida, USA; University of Illinois at Chicago, Center for Palliative Care Research & Education (CPCRE), Chicago, Illinois, USA.'}, {'ForeName': 'Miriam O', 'Initials': 'MO', 'LastName': 'Ezenwa', 'Affiliation': 'Department of Biobehavioral Nursing Science, College of Nursing, University of Florida, Gainesville, Florida, USA; University of Illinois at Chicago, Center for Palliative Care Research & Education (CPCRE), Chicago, Illinois, USA.'}, {'ForeName': 'Marie L', 'Initials': 'ML', 'LastName': 'Suarez', 'Affiliation': 'University of Illinois at Chicago, Center for Palliative Care Research & Education (CPCRE), Chicago, Illinois, USA.'}, {'ForeName': 'Brenda W', 'Initials': 'BW', 'LastName': 'Dyal', 'Affiliation': 'Department of Biobehavioral Nursing Science, College of Nursing, University of Florida, Gainesville, Florida, USA; University of Illinois at Chicago, Center for Palliative Care Research & Education (CPCRE), Chicago, Illinois, USA.'}, {'ForeName': 'Anayza', 'Initials': 'A', 'LastName': 'Gill', 'Affiliation': 'Rainbow Hospice and Palliative Care, Mount Prospect, Illinois, USA.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Hipp', 'Affiliation': 'Horizon Hospice & Palliative Care, Chicago, Illinois, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Shea', 'Affiliation': 'Rainbow Hospice and Palliative Care, Mount Prospect, Illinois, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': 'Horizon Hospice & Palliative Care, Chicago, Illinois, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Frank', 'Affiliation': 'Rainbow Hospice and Palliative Care, Mount Prospect, Illinois, USA.'}, {'ForeName': 'Nargis', 'Initials': 'N', 'LastName': 'Nardi', 'Affiliation': 'Rainbow Hospice and Palliative Care, Mount Prospect, Illinois, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Murray', 'Affiliation': 'Horizon Hospice & Palliative Care, Chicago, Illinois, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Glendenning', 'Affiliation': 'Horizon Hospice & Palliative Care, Chicago, Illinois, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Perez', 'Affiliation': 'Horizon Hospice & Palliative Care, Chicago, Illinois, USA.'}, {'ForeName': 'Jesus D', 'Initials': 'JD', 'LastName': 'Carrasco', 'Affiliation': 'University of Illinois at Chicago, Center for Palliative Care Research & Education (CPCRE), Chicago, Illinois, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shuey', 'Affiliation': 'University of Illinois at Chicago, Center for Palliative Care Research & Education (CPCRE), Chicago, Illinois, USA.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Angulo', 'Affiliation': 'University of Illinois at Chicago, Center for Palliative Care Research & Education (CPCRE), Chicago, Illinois, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'McCurry', 'Affiliation': 'Rainbow Hospice and Palliative Care, Mount Prospect, Illinois, USA.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'Horizon Hospice & Palliative Care, Chicago, Illinois, USA.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Butler', 'Affiliation': 'Horizon Hospice & Palliative Care, Chicago, Illinois, USA.'}, {'ForeName': 'Zaijie Jim', 'Initials': 'ZJ', 'LastName': 'Wang', 'Affiliation': 'Department of Biopharmaceutical Sciences, College of Pharmacy, University of Illinois at Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Molokie', 'Affiliation': 'Department of Biopharmaceutical Sciences, College of Pharmacy, University of Illinois at Chicago, Chicago, Illinois, USA; Department of Medicine, College of Medicine, University of Illinois at Chicago, Chicago, Illinois, USA; Jesse Brown VA Medical Center, Chicago, Illinois, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2019.10.028']
3368,31302514,One-year trajectories of mental health and work outcomes post return to work in patients with common mental disorders.,"BACKGROUND


We investigated one-year trajectories of symptom recovery, work functioning and the return to work percentage (RTW%) among patients with common mental disorders (CMDs).
METHODS


Data were used from a cluster-randomised controlled trial evaluating a problem-solving intervention for CMD patients (N = 158) who had returned to work. Information on anxiety and depressive symptoms, work functioning and RTW% was collected at baseline and 3, 6 and 12 months follow-up. Latent class growth analyses were used to identify trajectories for the four outcomes and investigate how these trajectories clustered in higher order latent classes. Additionally, we investigated the relation between patient characteristics and class membership.
RESULTS


We identified four trajectories for all four outcomes and derived three higher order latent classes: slow recovery (42% [66/158]) (high anxiety and depressive symptoms, moderate to low work functioning and fast RTW); fast recovery (25% [40/158]) (low anxiety and depressive symptoms, high work functioning and fast RTW); and gradual recovery (33% [52/158] (decreasing anxiety and depressive symptoms, increasing or low work functioning and fast RTW). Participants with a higher work engagement and readiness to stay at work were more likely to belong to the fast recovery class.
LIMITATIONS


Due to the relatively small sample size, some trajectories consisted of few participants. Symptom severity was self-reported.
CONCLUSIONS


Many CMD patients experience high levels of mental health symptoms and work functioning problems during the year post RTW. Creating realistic recovery expectations (for both patients and their environments) could be important for successful and sustainable recovery and work participation.",2019,Creating realistic recovery expectations (for both patients and their environments) could be important for successful and sustainable recovery and work participation.,"['patients with common mental disorders', 'CMD patients (N\u202f=\u202f158) who had returned to work', 'patients with common mental disorders (CMDs']",['problem-solving intervention'],"['anxiety and depressive symptoms, work functioning and RTW', 'anxiety and depressive symptoms, increasing or low work functioning and fast RTW', 'mental health symptoms and work functioning problems', 'anxiety and depressive symptoms, moderate to low work functioning and fast RTW); fast recovery (25% [40/158]) (low anxiety and depressive symptoms, high work functioning and fast RTW); and gradual recovery']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0425105', 'cui_str': 'Back to Work'}]","[{'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439833', 'cui_str': 'Gradual (qualifier value)'}]",,0.079662,Creating realistic recovery expectations (for both patients and their environments) could be important for successful and sustainable recovery and work participation.,"[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Arends', 'Affiliation': 'Department of Health Sciences, Community & Occupational Medicine, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands. Electronic address: i.arends@umcg.nl.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Almansa', 'Affiliation': 'Department of Health Sciences, Community & Occupational Medicine, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Stansfeld', 'Affiliation': 'Centre for Psychiatry, Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'B C', 'Initials': 'BC', 'LastName': 'Amick', 'Affiliation': 'Robert Stempel College of Public Health & Social Work, Department of Health Policy and Management, Florida International University, Miami, FL, USA; Institute for Work & Health, Toronto, Canada.'}, {'ForeName': 'J J L', 'Initials': 'JJL', 'LastName': 'van der Klink', 'Affiliation': 'School of Social and Behavioural Sciences, Tranzo, Tilburg University, Tilburg, the Netherlands.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Bültmann', 'Affiliation': 'Department of Health Sciences, Community & Occupational Medicine, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}]",Journal of affective disorders,['10.1016/j.jad.2019.07.018']
3369,32057490,Efficacy of BPPV diagnosis and treatment system for benign paroxysmal positional vertigo.,"OBJECTIVES


To evaluate the efficacy of automatic benign paroxysmal positional vertigo (BPPV) diagnosis and treatment system for BPPV compared with the manual repositioning group.
METHODS


Two hundred thirty patients diagnosed as idiopathic BPPV who were admitted from August 2018 to July 2019 in Zhejiang Hospital were included. Among them, 150 patients of posterior semicircular canal BPPV(pc-BPPV), 53 patients of horizontal semicircular canal BPPV(hc-BPPV), and 27 patients of horizontal semicircular canal calculus (hc-BPPV-cu) were randomly treated with BPPV diagnosis and treatment system(the experimental group) or manual repositioning (the control group). Resolution of vertigo and nystagmus on the Dix-Hallpike and Roll test on day 3,day 7,day 14 and day 28 follow-up after first treatment was the main outcome measure to assess the efficacy of treatment.
RESULTS


At 3-day and 7-day follow-up after treatment with BPPV diagnosis and treatment system, 79%, 91%had complete resolution of vertigo and nystagmus, the effective rate in the experimental group were significantly higher than those in the control group, the differences were statistically significant(P < .05). On day 14, the effective rate in the experimental group (96%) was slightly higher than that in the control group(91%), but there was no significant difference between the two groups. And at 28-day after the first treatment, the effective rate was 100% in the experimental group and the control group. The repositioning efficiency of pc-BPPV (the first, second, third treatment), hc-BPPV (the first, second, third treatment), hc-BPPV-cu(the first, second treatment) in the experimental group were higher than the control group, and the secondary reposition of pc-BPPV in the experimental group was significantly higher than the control group(96%vs.84%; P < .05). While for the hc-BPPV-cu patients, the effective rate of the third treatment in the experimental group was slightly lower than that of the control group, but the differences were not statistically significant.
CONCLUSIONS


BPPV diagnosis and treatment system is effective for the treatment of BPPV, with a better effective rate than those treated with manual maneuver, and is safe and easy to perform on patients.",2020,"On day 14, the effective rate in the experimental group (96%) was slightly higher than that in the control group(91%), but there was no significant difference between the two groups.","['150 patients of posterior semicircular canal BPPV(pc-BPPV), 53 patients of horizontal semicircular canal BPPV(hc-BPPV), and 27 patients of horizontal semicircular canal calculus (hc-BPPV-cu', 'Two hundred thirty patients diagnosed as idiopathic BPPV who were admitted from August 2018 to July 2019 in Zhejiang Hospital were included', 'benign paroxysmal positional vertigo']","['BPPV diagnosis', 'BPPV diagnosis and treatment system(the experimental group) or manual repositioning']","['effective rate', 'vertigo and nystagmus, the effective rate', 'Resolution of vertigo and nystagmus', 'repositioning efficiency of pc-BPPV', 'secondary reposition of pc-BPPV']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1288300', 'cui_str': 'Structure of posterior semicircular canal'}, {'cui': 'C0155502', 'cui_str': 'Vertigo, Benign Recurrent'}, {'cui': 'C0930838', 'cui_str': 'Structure of lateral semicircular canal'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0155502', 'cui_str': 'Vertigo, Benign Recurrent'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0556030', 'cui_str': 'Repositioning (procedure)'}]","[{'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0042571', 'cui_str': 'Spinning Sensation'}, {'cui': 'C0028738', 'cui_str': 'Nystagmus, Pathologic'}, {'cui': 'C0556030', 'cui_str': 'Repositioning (procedure)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0155502', 'cui_str': 'Vertigo, Benign Recurrent'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",230.0,0.0199149,"On day 14, the effective rate in the experimental group (96%) was slightly higher than that in the control group(91%), but there was no significant difference between the two groups.","[{'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Lou', 'Affiliation': 'Department of Neurology, Zhejiang Hospital, Hangzhou 310013, China.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Cai', 'Affiliation': 'Department of Neurology, Zhejiang Hospital, Hangzhou 310013, China.'}, {'ForeName': 'Liangguo', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Neurology, Zhejiang Hospital, Hangzhou 310013, China.'}, {'ForeName': 'Yanwen', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Zhejiang Hospital, Hangzhou 310013, China.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Zhuang', 'Affiliation': 'Department of Neurology, Zhejiang Hospital, Hangzhou 310013, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Zhejiang Hospital, Hangzhou 310013, China. Electronic address: liuxiaoli0907@126.com.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102412']
3370,31770148,Positive End-expiratory Pressure and Distribution of Ventilation in Pneumoperitoneum Combined with Steep Trendelenburg Position.,"BACKGROUND


Pneumoperitoneum and a steep Trendelenburg position during robot-assisted laparoscopic prostatectomy have been demonstrated to promote a cranial shift of the diaphragm and the formation of atelectasis in the dorsal parts of the lungs. However, neither an impact of higher positive end-expiratory pressure (PEEP) on preserving the ventilation in the dorsal region nor its physiologic effects have been fully examined. The authors hypothesized that PEEP of 15 cm H2O during robot-assisted laparoscopic prostatectomy might maintain ventilation in the dorsal parts and thus improve lung mechanics.
METHODS


In this randomized controlled study, 48 patients undergoing robot-assisted laparoscopic prostatectomy were included in the analysis. Patients were assigned to the conventional PEEP (5 cm H2O) group or the high PEEP (15 cm H2O) group. Regional ventilation was monitored using electrical impedance tomography before and after the establishment of pneumoperitoneum and 20° Trendelenburg position during the surgery. The primary endpoint was the regional ventilation in the dorsal parts of the lungs while the secondary endpoints were lung mechanics and postoperative lung function.
RESULTS


Compared to that in the conventional PEEP group, the fraction of regional ventilation in the most dorsal region was significantly higher in the high PEEP group during pneumoperitoneum and Trendelenburg position (mean values at 20 min after taking Trendelenburg position: conventional PEEP, 5.5 ± 3.9%; high PEEP, 9.9 ± 4.7%; difference, -4.5%; 95% CI, -7.4 to -1.6%; P = 0.004). Concurrently, lower driving pressure (conventional PEEP, 14.9 ± 2.5 cm H2O; high PEEP, 11.5 ± 2.8 cm H2O; P < 0.001), higher lung dynamic compliance, and better oxygenation were demonstrated in the high PEEP group. Postoperative lung function did not differ between the groups.
CONCLUSIONS


Application of a PEEP of 15 cm H2O resulted in more homogeneous ventilation and favorable physiologic effects during robot-assisted laparoscopic prostatectomy but did not improve postoperative lung function.",2020,"Compared to that in the conventional PEEP group, the fraction of regional ventilation in the most dorsal region was significantly higher in the high PEEP group during pneumoperitoneum and Trendelenburg position (mean values at 20 min after taking Trendelenburg position: conventional PEEP, 5.5 ± 3.9%; high PEEP, 9.9 ± 4.7%; difference, -4.5%; 95% CI, -7.4 to -1.6%; P = 0.004).","['48 patients undergoing', 'patients undergoing']","['conventional PEEP (5\u2009cm H2O) group or the high PEEP', 'robot-assisted laparoscopic prostatectomy, 15 but not 5\u2009cm H2O of positive end-expiratory pressure increased ventilation', 'Pneumoperitoneum Combined with Steep Trendelenburg Position', 'conventional PEEP', 'robot-assisted laparoscopic prostatectomy', 'Pneumoperitoneum and a steep Trendelenburg position during robot-assisted laparoscopic prostatectomy']","['Positive End-expiratory Pressure and Distribution of Ventilation', 'lower driving pressure', 'Postoperative lung function', 'normal lung mechanics and gas exchangeHigh positive end-expiratory pressure', 'postoperative lung function', 'homogeneous ventilation and favorable physiologic effects', 'higher lung dynamic compliance, and better oxygenation', 'Regional ventilation', 'higher positive end-expiratory pressure (PEEP', 'regional ventilation in the dorsal parts of the lungs while the secondary endpoints were lung mechanics and postoperative lung function', 'fraction of regional ventilation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0863179', 'cui_str': 'Peeping'}, {'cui': 'C3177469', 'cui_str': '(pipzH2)(cdo)H2O'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}, {'cui': 'C0419024', 'cui_str': 'Positive end expiratory pressure increased (procedure)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0277812', 'cui_str': 'Trendelenburg Position'}]","[{'cui': 'C3494516', 'cui_str': 'Positive end expiratory pressure (observable entity)'}, {'cui': 'C0231933', 'cui_str': 'Distribution of ventilation, function (observable entity)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0429680', 'cui_str': 'Dynamic compliance (observable entity)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0863179', 'cui_str': 'Peeping'}, {'cui': 'C0442054', 'cui_str': 'Dorsal part (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}]",48.0,0.0695563,"Compared to that in the conventional PEEP group, the fraction of regional ventilation in the most dorsal region was significantly higher in the high PEEP group during pneumoperitoneum and Trendelenburg position (mean values at 20 min after taking Trendelenburg position: conventional PEEP, 5.5 ± 3.9%; high PEEP, 9.9 ± 4.7%; difference, -4.5%; 95% CI, -7.4 to -1.6%; P = 0.004).","[{'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Shono', 'Affiliation': 'From the Department of Anesthesiology, Shimane University, Faculty of Medicine, Izumo, Japan (A.S., N.K., T.F., K.U., T.N., Y.S.) the Department of Anesthesiology and Intensive Care Medicine, Rostock University Medical Center, Rostock, Germany (S.H.B., A.D.W.).'}, {'ForeName': 'Nozomi', 'Initials': 'N', 'LastName': 'Katayama', 'Affiliation': ''}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Fujihara', 'Affiliation': ''}, {'ForeName': 'Stephan H', 'Initials': 'SH', 'LastName': 'Böhm', 'Affiliation': ''}, {'ForeName': 'Andreas D', 'Initials': 'AD', 'LastName': 'Waldmann', 'Affiliation': ''}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Ugata', 'Affiliation': ''}, {'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Nikai', 'Affiliation': ''}, {'ForeName': 'Yoji', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003062']
3371,32043533,[Constraint-induced movement therapy in the rehabilitation of hemineglect after a stroke].,"INTRODUCTION


Hemineglect produces a lower capacity for recovery after the stroke and so far there are no rehabilitation techniques that have proven to be effective at functional level.
AIMS


The main objective of this work was to assess whether the modified constraint-induced movement therapy (mCIMT)for hemineglect produces greater benefits than conventional therapy on functional hemineglect. Secondary objectives were to assess whether mCIMT produces greater benefits on upper and lower limb function as well as on the degree of autonomy and disability of patients with in relation to conventional therapy.
PATIENTS AND METHODS


We have recruited 30 patients with ischemic stroke and diagnosis of hemineglect randomly assigned to mCIMT group (n = 15) or conventional therapy group (n = 15). We used the Catherine Bergego Scale (CBS) for assessment hemineglect; Fugl-Meyer tests for the motor function of lower and upper limb, and Barthel index and modified Rankin scale for the rest of objectives.
RESULTS


We have found significant differences in favour of mCIMT group in the CBS after treatment and three months later once finished. We have not found differences between groups for the rest of variables.
CONCLUSIONS


mCIMT could be a more effective therapy than conventional therapy to improve the symptoms of hemineglect in the acute stroke. However, it may be clinically more recommended in patients with a certain motor function after stroke.",2020,"Secondary objectives were to assess whether mCIMT produces greater benefits on upper and lower limb function as well as on the degree of autonomy and disability of patients with in relation to conventional therapy.
","['We have recruited 30 patients with ischemic stroke and diagnosis of hemineglect randomly assigned to mCIMT group (n = 15) or', 'group (n = 15']","['conventional therapy', 'mCIMT', 'modified constraint-induced movement therapy (mCIMT)for hemineglect', 'Constraint-induced movement therapy']","['Catherine Bergego Scale (CBS', 'degree of autonomy and disability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy (regime/therapy)'}]","[{'cui': 'C0222045'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",30.0,0.0524868,"Secondary objectives were to assess whether mCIMT produces greater benefits on upper and lower limb function as well as on the degree of autonomy and disability of patients with in relation to conventional therapy.
","[{'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Marándola', 'Affiliation': 'Complejo Hospitalario Universitario de Santiago de Compostela, 15706 Santiago de Compostela, España.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Jiménez-Martín', 'Affiliation': 'Complejo Hospitalario Universitario de Santiago de Compostela, 15706 Santiago de Compostela, España.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rodríguez-Yáñez', 'Affiliation': 'Complejo Hospitalario Universitario de Santiago de Compostela, 15706 Santiago de Compostela, España.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Arias-Rivas', 'Affiliation': 'Complejo Hospitalario Universitario de Santiago de Compostela, 15706 Santiago de Compostela, España.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Santamaría-Calavid', 'Affiliation': 'Complejo Hospitalario Universitario de Santiago de Compostela, 15706 Santiago de Compostela, España.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Castillo', 'Affiliation': 'Complejo Hospitalario Universitario de Santiago de Compostela, 15706 Santiago de Compostela, España.'}]",Revista de neurologia,['10.33588/rn.7004.2019330']
3372,32057733,"Transverse, vertical, and anterior-posterior changes between tooth-anchored versus Dresden bone-anchored rapid maxillary expansion 6 months post-expansion: A CBCT randomized controlled clinical trial.","OBJECTIVE


The main aim of this randomized clinical trial was to determine 3 dimensional skeletal and dental changes six months after the use of bone-anchored versus tooth-anchored rapid maxillary expanders in adolescents. The secondary aim was to determine the symmetrical or asymmetrical expansion pattern between both appliances.
MATERIALS AND METHODS


Fifty adolescents with skeletally constricted maxilla (mean age 13-14 years) were randomly assigned into: Dresden B-RME, Hyrax T-RME, or untreated control groups. CBCT scans were taken at initial and expander removal (6 months). Three-dimensional references and treatment landmarks were identified. Orthogonal distances were calculated from those landmarks. The main outcome was to compare skeletal and dental changes in each group and the secondary outcome was to verify if these changes were symmetric or not. Data was analysed using descriptive statistics and repeated measure MANCOVA and MANOVA.
RESULTS


Both treatment groups showed significant skeletal and dental expansion compared to controls. T-RME group had greater mean inter-molar crown expansion (5.66mm) than the B-RME group (4.17mm). Both T-RME and B-RME groups showed significant skeletal maxillary expansion compared to controls (mean 1.27mm and 1.31mm respectively, both p<0.01), although no significant difference was found between both appliances. B-RME group showed a lower ratio of dental to skeletal expansion than T-RME group. T-RME showed a symmetrical expansion pattern, whereas the B-RME showed an asymmetrical pattern relative to mid-sagittal plane. The extent of molar crown expansion was 1.84mm greater on the TAD-side compared to the Implant-side. T-RME group showed significant anterior movement of the maxillary first premolar and molar (1.5mm, p<0.05), and vertical dental extrusion (1.8mm). No significant dental vertical or anterior-posterior changes were noted in the B-RME group.
CONCLUSIONS


T-RME and B-RME produced similar amounts of skeletal expansion. B-RME group produced a lower component of dental expansion. Due to the Dresden B-RME configuration, asymmetrical expansion was noted.",2020,T-RME group had greater mean inter-molar crown expansion (5.66mm) than the B-RME group (4.17mm).,"['Fifty adolescents with skeletally constricted maxilla (mean age 13-14 years', 'adolescents']","['tooth-anchored versus Dresden bone-anchored rapid maxillary expansion', 'bone-anchored versus tooth-anchored rapid maxillary expanders', 'Dresden B-RME, Hyrax T-RME, or untreated control groups']","['lower ratio of dental to skeletal expansion', 'Orthogonal distances', 'dental vertical or anterior-posterior changes', 'skeletal and dental expansion', 'molar crown expansion', 'skeletal maxillary expansion', 'skeletal and dental changes', 'mean inter-molar crown expansion']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1444778', 'cui_str': 'Constricting'}, {'cui': 'C0024947', 'cui_str': 'Maxillary Bone'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C1720978', 'cui_str': 'Bone Anchors'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0600288', 'cui_str': 'Maxillary Expansion'}, {'cui': 'C0020696', 'cui_str': 'Hyraxes'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C3853546', 'cui_str': 'Dental Crowns'}, {'cui': 'C0600288', 'cui_str': 'Maxillary Expansion'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}]",50.0,0.0824566,T-RME group had greater mean inter-molar crown expansion (5.66mm) than the B-RME group (4.17mm).,"[{'ForeName': 'Manuel O', 'Initials': 'MO', 'LastName': 'Lagravère', 'Affiliation': 'University of Alberta, Orthodontic Graduate Program, ECHA 5-524, Faculty of Medicine and Dentistry, 11405-87 Ave, Edmonton, AB, Canada. Electronic address: mlagravere@ualberta.ca.'}, {'ForeName': 'Connie P', 'Initials': 'CP', 'LastName': 'Ling', 'Affiliation': 'Private Practice, Toronto, ON, Canada; Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Woo', 'Affiliation': 'Computer Engineer, Toronto, ON, Canada.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Harzer', 'Affiliation': 'Technical University of Dresden, Department of Orthodontics, Fetscherstr. 72, 01307 Dresden, Germany.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Major', 'Affiliation': 'University of Alberta, Orthodontic Graduate Program, ECHA 5-524, Faculty of Medicine and Dentistry, 11405-87 Ave, Edmonton, AB, Canada.'}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Carey', 'Affiliation': 'University of Alberta, Donadeo Innovation Centre for Engineering, Department of Mechanical Engineering, Faculty of Engineering, T6G 10-265 Edmonton, AB, Canada.'}]",International orthodontics,['10.1016/j.ortho.2020.01.003']
3373,32055820,"Anti-inflammatory Diet In Rheumatoid Arthritis (ADIRA)-a randomized, controlled crossover trial indicating effects on disease activity.","BACKGROUND


Many patients with rheumatoid arthritis (RA) report symptom relief from certain foods. Earlier research indicates positive effects of food and food components on clinical outcomes in RA, but insufficient evidence exists to provide specific dietary advice. Food components may interact but studies evaluating combined effects are lacking.
OBJECTIVES


We aimed to investigate if an anti-inflammatory diet reduces disease activity in patients with RA.
METHODS


In this single-blinded crossover trial, 50 patients with RA were randomly assigned to an intervention diet containing a portfolio of suggested anti-inflammatory foods, or a control diet similar to the general dietary intake in Sweden, for 10 wk. After a 4-mo washout period the participants switched diet. Food equivalent to ∼50% of energy requirements was delivered weekly to their homes. For the remaining meals, they were encouraged to consume the same type of foods as the ones provided during each diet. Primary outcome was change in Disease Activity Score in 28 joints-Erythrocyte Sedimentation Rate (DAS28-ESR). Secondary outcomes were changes in the components of DAS28-ESR (tender and swollen joints, ESR, and visual analog scale for general health) and DAS28-C-reactive protein.
RESULTS


In the main analysis, a linear mixed ANCOVA model including the 47 participants completing ≥1 diet period, there was no significant difference in DAS28-ESR between the intervention and control periods (P = 0.116). However, in unadjusted analyses, DAS28-ESR significantly decreased during the intervention period and was significantly lower after the intervention than after the control period in the participants who completed both periods (n = 44; median: 3.05; IQR: 2.41, 3.79 compared with median: 3.27; IQR: 2.69, 4.28; P = 0.04, Wilcoxon's Signed Rank test). No significant differences in the components were observed.
CONCLUSIONS


This trial indicates positive effects of a proposed anti-inflammatory diet on disease activity in patients with RA. Additional studies are required to determine if this diet can cause clinically relevant improvements.This trial was registered at clinicaltrials.gov as NCT02941055.",2020,"However, in unadjusted analyses, DAS28-ESR significantly decreased during the intervention period and was significantly lower after the intervention than after the control period in the participants who completed both periods (n = 44; median: 3.05; IQR: 2.41, 3.79 compared with median: 3.27; IQR: 2.69, 4.28; P = 0.04, Wilcoxon's Signed Rank test).","['50 patients with RA', 'Rheumatoid Arthritis', 'patients with rheumatoid arthritis (RA', 'patients with RA']","['intervention diet containing a portfolio of suggested anti-inflammatory foods, or a control diet similar to the general dietary intake in Sweden, for 10 wk', 'anti-inflammatory diet', 'Anti-inflammatory Diet']","['DAS28-ESR', 'components of DAS28-ESR (tender and swollen joints, ESR, and visual analog scale for general health) and DAS28-C-reactive protein', 'disease activity', 'change in Disease Activity Score in 28 joints-Erythrocyte Sedimentation Rate (DAS28-ESR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0234234', 'cui_str': 'Tender (qualifier value)'}, {'cui': 'C0152031', 'cui_str': 'Joint swelling (finding)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}]",50.0,0.133574,"However, in unadjusted analyses, DAS28-ESR significantly decreased during the intervention period and was significantly lower after the intervention than after the control period in the participants who completed both periods (n = 44; median: 3.05; IQR: 2.41, 3.79 compared with median: 3.27; IQR: 2.69, 4.28; P = 0.04, Wilcoxon's Signed Rank test).","[{'ForeName': 'Anna K E', 'Initials': 'AKE', 'LastName': 'Vadell', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Linnea', 'Initials': 'L', 'LastName': 'Bärebring', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hulander', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Gjertsson', 'Affiliation': 'Department of Rheumatology and Inflammation Research, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Lindqvist', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Winkvist', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa019']
3374,31361535,"Pemetrexed, Bevacizumab, or the Combination As Maintenance Therapy for Advanced Nonsquamous Non-Small-Cell Lung Cancer: ECOG-ACRIN 5508.","PURPOSE


Pemetrexed or bevacizumab is used for maintenance therapy of advanced nonsquamous non-small-cell lung cancer (NSCLC). The combination of bevacizumab and pemetrexed has also demonstrated efficacy. We conducted a randomized study to determine the optimal maintenance therapy.
PATIENTS AND METHODS


Patients with advanced nonsquamous NSCLC and no prior systemic therapy received carboplatin (area under the curve, 6), paclitaxel (200 mg/m 2 ), and bevacizumab (15 mg/kg) for up to four cycles. Patients without progression after four cycles were randomly assigned to maintenance therapy with bevacizumab (15 mg/kg), pemetrexed (500 mg/m 2 ), or a combination of the two agents. The primary end point was overall survival, with bevacizumab serving as the control group.
RESULTS


Of the 1,516 patients enrolled, 874 (57%) were randomly assigned after induction therapy to one of the three maintenance therapy groups. With a median follow-up of 50.6 months, median survival with pemetrexed was 15.9 months, compared with 14.4 months with bevacizumab (hazard ratio [HR], 0.86;  P  = .12); median survival with pemetrexed and bevacizumab was 16.4 months (HR, 0.9;  P  = .28); median progression-free survival was 4.2, 5.1 (HR, 0.85;  P  = .06), and 7.5 months (HR, 0.67;  P  < .001) for the three groups, respectively. Incidence of worst grade 3 to 4 toxicity was 29%, 37%, and 51%, respectively, for bevacizumab, pemetrexed, and the combination regimen.
CONCLUSION


Single-agent bevacizumab or pemetrexed is efficacious as maintenance therapy for advanced nonsquamous NSCLC. Because of a lack of survival benefit and higher toxicity, the combination of bevacizumab and pemetrexed cannot be recommended.",2019,"Incidence of worst grade 3 to 4 toxicity was 29%, 37%, and 51%, respectively, for bevacizumab, pemetrexed, and the combination regimen.
","['Patients with advanced nonsquamous NSCLC and no prior systemic therapy received', 'advanced nonsquamous NSCLC', 'Patients without progression after four cycles', 'Advanced Nonsquamous Non-Small-Cell Lung Cancer', '1,516 patients enrolled, 874 (57', 'advanced nonsquamous non-small-cell lung cancer (NSCLC']","['bevacizumab and pemetrexed', 'bevacizumab', 'pemetrexed', 'maintenance therapy with bevacizumab', 'Pemetrexed or bevacizumab', 'bevacizumab, pemetrexed', 'bevacizumab or pemetrexed', 'Pemetrexed, Bevacizumab, or the Combination', 'carboplatin (area under the curve, 6), paclitaxel']","['median survival', 'overall survival', ' median progression-free survival', 'survival benefit and higher toxicity', 'Incidence of worst grade 3 to 4 toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]",1516.0,0.118515,"Incidence of worst grade 3 to 4 toxicity was 29%, 37%, and 51%, respectively, for bevacizumab, pemetrexed, and the combination regimen.
","[{'ForeName': 'Suresh S', 'Initials': 'SS', 'LastName': 'Ramalingam', 'Affiliation': 'Winship Cancer Institute of Emory University, Atlanta, GA.'}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Dahlberg', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Chandra P', 'Initials': 'CP', 'LastName': 'Belani', 'Affiliation': 'Penn State Health Milton S. Hershey Medical Center, Hershey, PA.'}, {'ForeName': 'Joel N', 'Initials': 'JN', 'LastName': 'Saltzman', 'Affiliation': 'University Hospitals Seidman Cancer Center, Cleveland, OH.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Pennell', 'Affiliation': 'Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Gopakumar S', 'Initials': 'GS', 'LastName': 'Nambudiri', 'Affiliation': ""St John's Hospital, Maplewood, MN.""}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'McCann', 'Affiliation': 'Baystate Health, Springfield, MA.'}, {'ForeName': 'Jerome D', 'Initials': 'JD', 'LastName': 'Winegarden', 'Affiliation': 'St Joseph Mercy Ann Arbor Hospital, Ann Arbor, MI.'}, {'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'Kassem', 'Affiliation': 'Sinai Cancer Care and Infusion Center, Chicago, IL.'}, {'ForeName': 'Mohamed K', 'Initials': 'MK', 'LastName': 'Mohamed', 'Affiliation': 'Moses H. Cone Memorial Hospital, Greensboro, NC.'}, {'ForeName': 'Jan M', 'Initials': 'JM', 'LastName': 'Rothman', 'Affiliation': 'Hillman Cancer Center, University Pittsburgh Medical Center, Pittsburgh, PA.'}, {'ForeName': 'Alan P', 'Initials': 'AP', 'LastName': 'Lyss', 'Affiliation': 'Missouri Baptist Medical Center, St Louis, MO.'}, {'ForeName': 'Leora', 'Initials': 'L', 'LastName': 'Horn', 'Affiliation': 'Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Stinchcombe', 'Affiliation': 'Duke University, Durham, NC.'}, {'ForeName': 'Joan H', 'Initials': 'JH', 'LastName': 'Schiller', 'Affiliation': 'Inova Schar Cancer Center, Fairfax, VA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01006']
3375,31524825,Moderate-Intensity Continuous Training or High-Intensity Interval Training with or without Resistance Training for Altering Body Composition in Postmenopausal Women.,"PURPOSE


This study aimed to compare body composition changes induced by moderate-intensity continuous training (MICT), high-intensity interval training (HIIT), or HIIT + resistance training (RT) programs (3 d·wk, 12 wk) in overweight/obese postmenopausal women, and to determine whether fat mass reduction is related to greater fat oxidation (FatOx).
METHODS


Participants (n = 27) were randomized in three groups: MICT (40 min at 55%-60% of peak power output), HIIT (60 × 8 s at 80%-90% of peak HR, 12 s active recovery), and HIIT + RT (HIIT + 8 whole-body exercises: 1 set of 8-12 repetitions). Dual-energy x-ray absorptiometry was used to measure whole-body and abdominal/visceral fat mass (FM) and fat-free mass. FatOx was determined at rest, during a moderate-intensity exercise (40 min at 50% of peak power output), and for 20 min postexercise, before and after training.
RESULTS


Overall, energy intake and physical activity levels did not vary from the beginning to the end of the intervention. Body weight and total FM decreased in all groups over time, but significant abdominal/visceral FM losses were observed only in HIIT and HIIT + RT groups. When expressed in percentage, total FM, fat-free mass, and muscle mass were significantly modified only by HIIT + RT training. FatOx did not change at rest but increased similarly in the three groups during and after exercise. Therefore, the HIIT-induced greater FM loss was not related to higher FatOx during or after exercise.
CONCLUSIONS


MICT or HIIT ± RT could be proposed to nondieting postmenopausal women who are overweight/obese to decrease weight and whole-body FM. The HIIT programs were more effective than MICT in reducing abdominal/visceral FM. RT addition did not potentiate this effect but increased the percentage of muscle mass.",2020,"When expressed in percentage, total FM, FFM, and muscle mass were significantly modified only by HIIT + RT training.","['Postmenopausal Women', 'Participants (n=27', 'postmenopausal women with overweight/obesity']","['MICT', 'MICT or HIIT ± RT', 'moderate-intensity continuous training (MICT), high-intensity interval training (HIIT), or HIIT + resistance training (RT) programs', 'MICT or HIIT ± RT Programs', 'DXA', 'HIIT + RT (HIIT + 8 whole-body exercises']","['FatOx', 'Overall, energy intake and physical activity levels', 'abdominal/visceral FM losses', 'FM loss', 'percentage, total FM, FFM, and muscle mass', 'abdominal/visceral FM', 'percentage of muscle mass', 'Body weight and total FM']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",,0.0238033,"When expressed in percentage, total FM, FFM, and muscle mass were significantly modified only by HIIT + RT training.","[{'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Dupuit', 'Affiliation': 'Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Université Clermont Auvergne, EA 3533, Clermont-Ferrand, FRANCE.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Rance', 'Affiliation': 'Center of Resources, Expertise and Performance in Sports (CREPS), Bellerive-sur-Allier, FRANCE.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Morel', 'Affiliation': 'Center of Resources, Expertise and Performance in Sports (CREPS), Bellerive-sur-Allier, FRANCE.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Bouillon', 'Affiliation': 'Department of Cardiology, Vichy Hospital, Vichy, FRANCE.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'Clermont-Ferrand University Hospital, Biostatistics Unit (DRCI), Clermont-Ferrand, FRANCE.'}, {'ForeName': 'Alban', 'Initials': 'A', 'LastName': 'Bonnet', 'Affiliation': 'Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Université Clermont Auvergne, EA 3533, Clermont-Ferrand, FRANCE.'}, {'ForeName': 'Florie', 'Initials': 'F', 'LastName': 'Maillard', 'Affiliation': 'Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Université Clermont Auvergne, EA 3533, Clermont-Ferrand, FRANCE.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Duclos', 'Affiliation': 'Department of Sport Medicine and Functional Explorations, Clermont-Ferrand University Hospital, G. Montpied Hospital, Clermont-Ferrand, FRANCE.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Boisseau', 'Affiliation': 'Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Université Clermont Auvergne, EA 3533, Clermont-Ferrand, FRANCE.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002162']
3376,31652232,Increasing Students' Activity in Physical Education: Results of the Self-determined Exercise and Learning For FITness Trial.,"PURPOSE


To examine the effects of the Self-determined Exercise and Learning For FITness (SELF-FIT) intervention on students' moderate-to-vigorous physical activity (MVPA) and motivation in physical education (PE).
METHODS


In a clustered randomized controlled trial, 667 students (mean age, 14.4 yr; SD, 0.78) from 26 schools (i.e., clusters) were randomized into either an experimental group or a waitlist control group. Students in the experimental group received the SELF-FIT intervention, a school-based intervention designed to infuse fitness and game-like elements into PE using self-determination theory principles, whereas those in the control continued their classes using usual practices. Intervention content was provided by teachers who received training from the research team. The primary outcome was percentage of time spent in MVPA during PE. Secondary outcomes included basic psychological need satisfaction, motivation toward PE, leisure-time MVPA, and mental well-being. Data were analyzed using multilevel regression analyses and prespecified interactions were tested (i.e., group-time-sex).
RESULTS


Positive intervention effects were found on MVPA during PE (B, 4.00; 95% confidence interval, 2.96-5.04; d = 0.36). Regarding the participants' competence and autonomy need satisfaction, and autonomous motivation, the intervention effects were stronger in girls, compared with boys.
CONCLUSIONS


Fitness infusion and game-like elements, used according to self-determination theory principles, can enhance students' physical activity and motivation toward PE. This low-cost intervention has the potential to be scaled up and disseminated in secondary schools.",2020,"Regarding the participants' competence and autonomy need satisfaction, and autonomous motivation, the intervention effects were stronger in girls, compared to boys.
","['667 students (mean age = 14.4 years, SD = 0.78) from 26 schools (i.e., clusters']","['wait-list control group', 'SELF-FIT intervention', 'SELF-FIT intervention, a school-based intervention designed to infuse fitness and game-like elements into PE using self-determination theory principles']","['basic psychological need satisfaction, motivation towards PE, leisure-time MVPA, and mental well-being', 'percentage of time spent in MVPA during PE', ""students' moderate-to-vigorous physical activity (MVPA) and motivation in physical education (PE""]","[{'cui': 'C4517851', 'cui_str': '667 (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517480', 'cui_str': 'Zero point seven eight'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4707055', 'cui_str': 'Infuse'}, {'cui': 'C0013879', 'cui_str': 'Elements'}, {'cui': 'C0036595', 'cui_str': 'Self Determination'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0424578', 'cui_str': 'Sense of well-being'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0031805', 'cui_str': 'Physical Education'}]",,0.0469037,"Regarding the participants' competence and autonomy need satisfaction, and autonomous motivation, the intervention effects were stronger in girls, compared to boys.
","[{'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Ha', 'Affiliation': 'Department of Sports Science and Physical Education, The Chinese University of Hong Kong, HONG KONG.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Lonsdale', 'Affiliation': 'Institute for Positive Psychology and Education, Australian Catholic University, Australia.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Lubans', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Education, University of Newcastle, AUSTRALIA.'}, {'ForeName': 'Johan Y Y', 'Initials': 'JYY', 'LastName': 'Ng', 'Affiliation': 'Department of Sports Science and Physical Education, The Chinese University of Hong Kong, HONG KONG.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002172']
3377,31652241,Effects of Exergaming on Cognition and Gait in Older Adults at Risk for Falling.,"PURPOSE


To test whether an 8-wk exergaming (EG) program would improve cognition and gait characteristics compared with a traditional physical exercise (TPE) program in older adults at risk for falling.
METHODS


A pilot quasi-experimental study was conducted in adults age ≥65 yr at risk for falls, living in senior communities. Participants enrolled (n = 35) in either exercise program offered twice weekly for 8 wk. Cognition and single-task and dual-task gait characteristics were measured before and after the 8-wk exercise intervention. For each outcome, a repeated-measures ANCOVA adjusted for age, gender, and exercise intensity (ratings of perceived exertion, RPE) was used to examine the group-time interaction.
RESULTS


Twenty-nine participants (age, 77 ± 7 yr) completed either the EG program (n = 15) or the TPE program (n = 14). Statistically significant group-time interactions were observed in Trail Making Test Part A (P < 0.05) and single-task gait speed, stride length, swing time percentage, and double support percentage (all P < 0.05), and marginal group differences were observed in Mini-Mental State Examination (P = 0.07), all favoring the EG program. There were no statistically significant group differences in dual-task gait measurements except for swing time percentage and double support percentage, favoring the EG program.
CONCLUSIONS


An 8-wk EG program for older adults at risk for falls contributed to modest improvements in a number of cognitive measures and single-task but limited improvements in dual-task gait measures, compared with TPE. These findings support the need for larger trials to determine cognitive and mobility benefits related to EG.",2020,"There were no statistically significant group differences in dual-task gait measurements except for swing time percentage and double support percentage, favoring the EG program.
","['Twenty-nine participants (aged 77±7 yrs', 'older adults', 'Older Adults at Risk for Falling', 'older adults at risk for falling', 'adults aged ≥ 65 years at risk for falls, living in senior communities', 'Participants enrolled (N=35) in either']","['8-week exergaming (EG) program', 'traditional physical exercise (TPE) program', 'exercise program', 'TPE program', 'EG program']","['Cognition and single-task and dual-task gait characteristics', 'dual-task gait measures', 'cognition and gait characteristics', 'Cognition and Gait', 'dual-task gait measurements', 'Trail Making Test Part A (TMT-A, p<0.05) and single-task gait speed, stride length, swing time percentage, and double support percentage', 'Mini-Mental State Examination', 'exercise intensity (ratings of perceived exertion, RPE']","[{'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1268740', 'cui_str': 'Fall risk'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0040604', 'cui_str': 'Trail Making Test'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0445208', 'cui_str': 'RPE'}]",29.0,0.0204178,"There were no statistically significant group differences in dual-task gait measurements except for swing time percentage and double support percentage, favoring the EG program.
","[{'ForeName': 'Elisa F', 'Initials': 'EF', 'LastName': 'Ogawa', 'Affiliation': 'Department of Exercise and Health Sciences, College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA.'}, {'ForeName': 'Haikun', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Computer Science, College of Science and Mathematics, University of Massachusetts Boston, Boston, MA.'}, {'ForeName': 'Lap-Fai', 'Initials': 'LF', 'LastName': 'Yu', 'Affiliation': 'Department of Computer Science, George Mason University, Fairfax, VA.'}, {'ForeName': 'Philimon N', 'Initials': 'PN', 'LastName': 'Gona', 'Affiliation': 'Department of Exercise and Health Sciences, College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Fleming', 'Affiliation': 'Department of Exercise and Health Sciences, College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA.'}, {'ForeName': 'Suzanne G', 'Initials': 'SG', 'LastName': 'Leveille', 'Affiliation': 'Department of Nursing, College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA.'}, {'ForeName': 'Tongjian', 'Initials': 'T', 'LastName': 'You', 'Affiliation': 'Department of Exercise and Health Sciences, College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002167']
3378,31351901,Isokinetic eccentric training is more effective than constant load eccentric training for quadriceps rehabilitation following anterior cruciate ligament reconstruction: a randomized controlled trial.,"OBJECTIVE


To compare the effects of conventional (constant load) eccentric training and isokinetic eccentric training on quadriceps muscle mass, strength and functional performance in recreational athletes following anterior cruciate ligament (ACL) reconstruction.
METHODS


Thirty recreational male athletes (25 years old) undergoing ACL reconstruction received a standard rehabilitation program. Volunteers were randomized to conventional group (CG; n = 15) or isokinetic group (IG; n = 15) to be engaged in a 6-week (2 sessions/week) quadriceps eccentric training program at the extensor chair or at the isokinetic dynamometer, respectively. Assessments of quadriceps muscle mass (through magnetic resonance imaging), strength (through isokinetic dynamometry) and self-aware functionality (through questionnaire) were performed before and after the training programs. Single leg hop test performance was assessed only at post-training evaluation.
RESULTS


IG had significantly higher improvements than CG (p < 0.05) for all muscle mass outcomes (+17-23% vs. +5-9%), as well as for isometric (+34% vs. +20%) and eccentric (+85% vs. +23%) peak torques. There was no between-group difference (p > 0.05) for concentric peak torque, Lysholm score, and single leg hop test.
CONCLUSION


Isokinetic eccentric training promotes greater responses than conventional eccentric training on quadriceps muscle mass and strength of recreational athletes following ACL reconstruction.",2019,"RESULTS


IG had significantly higher improvements than CG (p < 0.05) for all muscle mass outcomes (+17-23% vs. +5-9%), as well as for isometric (+34% vs. +20%) and eccentric (+85% vs. +23%) peak torques.","['anterior cruciate ligament reconstruction', 'recreational athletes following anterior cruciate ligament (ACL) reconstruction', 'Thirty recreational male athletes (˜25 years old) undergoing']","['conventional (constant load) eccentric training and isokinetic eccentric training', 'Isokinetic eccentric training', 'ACL reconstruction received a standard rehabilitation program', 'constant load eccentric training', 'conventional eccentric training', 'conventional group (CG; n\u202f=\u202f15) or isokinetic group (IG; n\u202f=\u202f15) to be engaged in a 6-week (2 sessions/week) quadriceps eccentric training program at the extensor chair or at the isokinetic dynamometer, respectively']","['strength (through isokinetic dynamometry) and self-aware functionality (through questionnaire', 'quadriceps muscle mass, strength and functional performance', 'concentric peak torque, Lysholm score, and single leg hop test', 'peak torques', 'quadriceps muscle mass and strength of recreational athletes']","[{'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer (physical object)'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C3853978'}, {'cui': 'C0439744', 'cui_str': 'Concentric (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C4018995', 'cui_str': 'Hop'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]",,0.0180957,"RESULTS


IG had significantly higher improvements than CG (p < 0.05) for all muscle mass outcomes (+17-23% vs. +5-9%), as well as for isometric (+34% vs. +20%) and eccentric (+85% vs. +23%) peak torques.","[{'ForeName': 'Marlon Francys', 'Initials': 'MF', 'LastName': 'Vidmar', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil; Hospital Ortopédico de Passo Fundo, Passo Fundo, RS, Brazil. Electronic address: marlonfrancys@msn.com.'}, {'ForeName': 'Bruno Manfredini', 'Initials': 'BM', 'LastName': 'Baroni', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Alexandre Fróes', 'Initials': 'AF', 'LastName': 'Michelin', 'Affiliation': 'Hospital Ortopédico de Passo Fundo, Passo Fundo, RS, Brazil.'}, {'ForeName': 'Márcio', 'Initials': 'M', 'LastName': 'Mezzomo', 'Affiliation': 'Hospital Ortopédico de Passo Fundo, Passo Fundo, RS, Brazil.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Lugokenski', 'Affiliation': 'Hospital Ortopédico de Passo Fundo, Passo Fundo, RS, Brazil.'}, {'ForeName': 'Gilnei Lopes', 'Initials': 'GL', 'LastName': 'Pimentel', 'Affiliation': 'Physical Therapy Department, Universidade de Passo Fundo (UPF), Passo Fundo, RS, Brazil.'}, {'ForeName': 'Marcelo Faria', 'Initials': 'MF', 'LastName': 'Silva', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}]",Brazilian journal of physical therapy,['10.1016/j.bjpt.2019.07.003']
3379,31918942,Fractional Flow Reserve or Optical Coherence Tomography to Guide Management of Angiographically Intermediate Coronary Stenosis: A Single-Center Trial.,"OBJECTIVES


The aim of this study was to compare optical coherence tomographic (OCT) guidance and fractional flow reserve (FFR) guidance in patients with angiographically intermediate coronary lesions (AICLs) in a single-center, prospective, 1:1 randomized trial.
BACKGROUND


FFR and OCT imaging may help both in the assessment of AICLs and in percutaneous coronary intervention optimization.
METHODS


Patients with AICLs were randomized to FFR or OCT imaging. In the FFR arm, PCI was performed if FFR was ≤0.80. In the OCT imaging arm, PCI was performed if area stenosis was ≥75% or 50% to 75% with minimal luminal area <2.5 mm 2  or plaque rupture. Angina (evaluated using the Seattle Angina Questionnaire), major adverse cardiac events, and cost were assessed at the end of follow-up. The pre-defined primary endpoint was the composite of major adverse cardiac events or significant angina (defined as Seattle Angina Questionnaire frequency scale score <90) at 13 months.
RESULTS


A total of 350 patients (with 446 AICLs) were enrolled (176 randomized to FFR and 174 to OCT imaging). The primary endpoint of major adverse cardiac events or significant angina at 13 months occurred in 14.8% of patients in the FFR arm and in 8.0% in the OCT imaging arm (p = 0.048). This result was driven by a statistically nonsignificant lower occurrence of all primary endpoint components. Up to 13 months, the rate of medically managed patients was significantly higher (p < 0.001) and total cost significantly lower (p < 0.001) with FFR in comparison with OCT imaging.
CONCLUSIONS


In patients with AICLs, OCT guidance is associated with lower occurrence of the composite of major adverse cardiac events or significant angina. FFR guidance is associated with a higher rate of medical management and lower costs. FFR or OCT Guidance to Revascularize Intermediate Coronary Stenosis Using Angioplasty [FORZA]; NCT01824030).",2020,"Up to 13 months, the rate of medically managed patients was significantly higher (p < 0.001) and total cost significantly lower (p < 0.001) with FFR in comparison with OCT imaging.
","['patients with angiographically intermediate coronary lesions (AICLs', 'Patients with AICLs', '350 patients (with 446 AICLs) were enrolled (176 randomized to FFR and 174 to OCT imaging']","['FFR or OCT imaging', 'optical coherence tomographic (OCT) guidance and fractional flow reserve (FFR) guidance', 'Fractional Flow Reserve or Optical Coherence Tomography']","['major adverse cardiac events or significant angina at 13\xa0months', 'composite of major adverse cardiac events or significant angina (defined as Seattle Angina Questionnaire frequency scale score', 'total cost', 'Angina (evaluated using the Seattle Angina Questionnaire), major adverse cardiac events, and cost']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}]","[{'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",176.0,0.0356894,"Up to 13 months, the rate of medically managed patients was significantly higher (p < 0.001) and total cost significantly lower (p < 0.001) with FFR in comparison with OCT imaging.
","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Burzotta', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy. Electronic address: francesco.burzotta@unicatt.it.'}, {'ForeName': 'Antonio Maria', 'Initials': 'AM', 'LastName': 'Leone', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Aurigemma', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Aniello', 'Initials': 'A', 'LastName': 'Zambrano', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Zimbardo', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Manfredi', 'Initials': 'M', 'LastName': 'Arioti', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Rocco', 'Initials': 'R', 'LastName': 'Vergallo', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Giovanni Luigi', 'Initials': 'GL', 'LastName': 'De Maria', 'Affiliation': 'Department of Cardiology, John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Cerracchio', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Romagnoli', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Trani', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Crea', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.09.034']
3380,31918944,Effect of Intravascular Ultrasound-Guided Drug-Eluting Stent Implantation: 5-Year Follow-Up of the IVUS-XPL Randomized Trial.,"OBJECTIVES


The goal of this study was to evaluate whether the beneficial effect of use of intravascular ultrasound (IVUS) is sustained for long-term follow-up.
BACKGROUND


The use of IVUS promoted favorable 1-year clinical outcome in the IVUS-XPL (Impact of Intravascular Ultrasound Guidance on the Outcomes of Xience Prime Stents in Long Lesions) trial. It is not known, however, whether this effect is sustained for long-term follow-up.
METHODS


The IVUS-XPL trial randomized 1,400 patients with long coronary lesions (implanted stent length ≥28 mm) to receive IVUS-guided (n = 700) or angiography-guided (n = 700) everolimus-eluting stent implantation. Five-year clinical outcomes were investigated in patients who completed the original trial. The primary outcome was the composite of major adverse cardiac events, including cardiac death, target lesion-related myocardial infarction, or ischemia-driven target lesion revascularization at 5 years, analyzed by intention-to-treat.
RESULTS


Five-year follow-up was completed in 1,183 patients (85%). Major adverse cardiac events at 5 years occurred in 36 patients (5.6%) receiving IVUS guidance and in 70 patients (10.7%) receiving angiographic guidance (hazard ratio: 0.50; 95% confidence interval: 0.34 to 0.75; p = 0.001). The difference was driven mainly by a lower risk for target lesion revascularization (31 [4.8%] vs. 55 [8.4%]; hazard ratio: 0.54; 95% confidence interval: 0.33 to 0.89; p = 0.007). By landmark analysis, major adverse cardiac events between 1 and 5 years occurred in 17 patients (2.8%) receiving IVUS guidance and in 31 patients (5.2%) receiving angiographic guidance (hazard ratio: 0.53; 95% confidence interval: 0.29 to 0.95; p = 0.031).
CONCLUSIONS


Compared with angiography-guided stent implantation, IVUS-guided stent implantation resulted in a significantly lower rate of major adverse cardiac events up to 5 years. Sustained 5-year clinical benefits resulted from both within 1 year and from 1 to 5 years post-implantation. (Impact of Intravascular Ultrasound Guidance on the Outcomes of Xience Prime Stents in Long Lesions [IVUS-XPL Study]: Retrospective and Prospective Follow-Up Study; NCT03866486).",2020,"By landmark analysis, major adverse cardiac events between 1 and 5 years occurred in 17 patients (2.8%) receiving IVUS guidance and in 31 patients (5.2%) receiving angiographic guidance (hazard ratio: 0.53; 95% confidence interval: 0.29 to 0.95; p = 0.031).
","['1,400 patients with long coronary lesions (implanted stent length\xa0≥28\xa0mm) to receive']","['intravascular ultrasound (IVUS', 'Intravascular Ultrasound Guidance', 'IVUS-guided (n\xa0=\xa0700) or angiography-guided (n\xa0=\xa0700) everolimus-eluting stent implantation', 'Intravascular Ultrasound-Guided Drug-Eluting Stent Implantation', 'angiography-guided stent implantation, IVUS-guided stent implantation']","['Major adverse cardiac events', 'adverse cardiac events', 'composite of major adverse cardiac events, including cardiac death, target lesion-related myocardial infarction, or ischemia-driven target lesion revascularization at 5 years, analyzed by intention-to-treat', 'lower risk for target lesion revascularization', 'rate of major adverse cardiac events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C1444754', 'cui_str': 'Length property'}]","[{'cui': 'C0442123', 'cui_str': 'Intravascular (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure (procedure)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0203108', 'cui_str': 'Pyelogram'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}]",1400.0,0.212133,"By landmark analysis, major adverse cardiac events between 1 and 5 years occurred in 17 patients (2.8%) receiving IVUS guidance and in 31 patients (5.2%) receiving angiographic guidance (hazard ratio: 0.53; 95% confidence interval: 0.29 to 0.95; p = 0.031).
","[{'ForeName': 'Sung-Jin', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Mintz', 'Affiliation': 'Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Chul-Min', 'Initials': 'CM', 'LastName': 'Ahn', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Jung-Sun', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Byeong-Keuk', 'Initials': 'BK', 'LastName': 'Kim', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Young-Guk', 'Initials': 'YG', 'LastName': 'Ko', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Tae-Soo', 'Initials': 'TS', 'LastName': 'Kang', 'Affiliation': 'Dankook University College of Medicine, Cheonan, Korea.'}, {'ForeName': 'Woong-Chol', 'Initials': 'WC', 'LastName': 'Kang', 'Affiliation': 'Gil Hospital, Gachon University College of Medicine, Incheon, Korea.'}, {'ForeName': 'Yong Hoon', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Kangwon National University School of Medicine, Chuncheon, Korea.'}, {'ForeName': 'Seung-Ho', 'Initials': 'SH', 'LastName': 'Hur', 'Affiliation': 'Keimyung University College of Medicine, Daegu, Korea.'}, {'ForeName': 'Bum-Kee', 'Initials': 'BK', 'LastName': 'Hong', 'Affiliation': 'Gangnam Severance Hospital, Seoul, Korea.'}, {'ForeName': 'Donghoon', 'Initials': 'D', 'LastName': 'Choi', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Hyuckmoon', 'Initials': 'H', 'LastName': 'Kwon', 'Affiliation': 'Gangnam Severance Hospital, Seoul, Korea.'}, {'ForeName': 'Yangsoo', 'Initials': 'Y', 'LastName': 'Jang', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Myeong-Ki', 'Initials': 'MK', 'LastName': 'Hong', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea. Electronic address: mkhong61@yuhs.ac.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.09.033']
3381,31918946,Randomized Comparison of Ridaforolimus-Eluting and Zotarolimus-Eluting Coronary Stents: 2-Year Clinical Outcomes From the BIONICS and NIREUS Trials.,"OBJECTIVES


This study sought to determine clinical outcomes between treatment groups over long-term follow-up.
BACKGROUND


The safety and efficacy of a ridaforolimus-eluting stent (RES) was evaluated in the BIONICS (BioNIR Ridaforolimus-Eluting Coronary Stent System in Coronary Stenosis) and NIREUS (BioNIR Ridaforolimus Eluting Coronary Stent System [BioNIR] European Angiography Study) trials, demonstrating noninferiority of RES in comparison with a zotarolimus-eluting stent (ZES) regarding 1-year target lesion failure (TLF) and 6-month angiographic late lumen loss, respectively.
METHODS


Patient-level data from the BIONICS (N = 1,919) and NIREUS (N = 302) randomized trials were pooled, and outcomes in patients implanted with RES and ZES compared. Broad inclusion criteria allowed enrollment of patients with acute coronary syndromes and complex lesions. The primary endpoint was the 2-year rate of TLF or clinically driven target lesion revascularization.
RESULTS


A total of 2,221 patients (age 63.2 ± 10.3 years; 79.7% men) undergoing percutaneous coronary intervention with RES (n = 1,159) or ZES (n = 1,062) were included. Clinical and angiographic characteristics were similar between groups. At 2 years, the primary endpoint of TLF was similar among patients implanted with RES and ZES (7.0% vs. 7.2%; p = 0.94). Rates of target lesion revascularization (4.8% RES vs. 4.1% ZES; p = 0.41) and target vessel-related myocardial infarction (3.1% RES vs. 3.8% ZES; p = 0.52) did not differ between groups. The overall rate of stent thrombosis was also similar (0.5% RES vs. 0.9% ZES; p = 0.39).
CONCLUSIONS


In a pooled analysis of 2 randomized trials, 2-year clinical outcomes were similar between patients undergoing percutaneous coronary intervention with RES and ZES. These results support the long-term safety and efficacy of RES for the treatment of a broad population of patients with coronary artery disease.",2020,Rates of target lesion revascularization (4.8% RES vs. 4.1% ZES; p = 0.41) and target vessel-related myocardial infarction (3.1% RES vs. 3.8% ZES; p = ,"['patients with acute coronary syndromes and complex lesions', 'Patient-level data from the BIONICS (N\xa0=\xa01,919) and NIREUS', '2,221 patients (age 63.2 ± 10.3 years; 79.7% men) undergoing percutaneous coronary intervention with RES (n\xa0=\xa01,159) or ZES (n\xa0=\xa01,062) were included', 'patients with coronary artery disease']","['Ridaforolimus Eluting Coronary Stent System ', 'ridaforolimus-eluting stent (RES', 'Ridaforolimus-Eluting and Zotarolimus-Eluting Coronary Stents', 'BioNIR', 'zotarolimus-eluting stent (ZES', 'percutaneous coronary intervention with RES and ZES', 'RES', 'NIREUS (BioNIR', 'RES and ZES']","['target vessel-related myocardial infarction', '2-year rate of TLF or clinically driven target lesion revascularization', 'overall rate of stent thrombosis', 'TLF', 'Rates of target lesion revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005549', 'cui_str': 'Bionics'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517519', 'cui_str': 'Ten point three'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C2713007', 'cui_str': 'ridaforolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1700035', 'cui_str': 'zotarilumus'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}]",2221.0,0.217054,Rates of target lesion revascularization (4.8% RES vs. 4.1% ZES; p = 0.41) and target vessel-related myocardial infarction (3.1% RES vs. 3.8% ZES; p = ,"[{'ForeName': 'Maayan', 'Initials': 'M', 'LastName': 'Konigstein', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Tel Aviv-Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Pieter C', 'Initials': 'PC', 'LastName': 'Smits', 'Affiliation': 'Maasstad Ziekenhuis, Rotterdam, the Netherlands.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Love', 'Affiliation': 'St. Boniface General Hospital, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Ben-Yehuda', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Melek Ozgu', 'Initials': 'MO', 'LastName': 'Ozan', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Mengdan', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Gidon Y', 'Initials': 'GY', 'LastName': 'Perlman', 'Affiliation': 'Hadassah Hebrew University Medical Center, Jerusalem, Israel; Medinol Ltd., Tel Aviv, Israel.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Leon', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kandzari', 'Affiliation': 'Piedmont Heart Institute, Atlanta, Georgia. Electronic address: david.kandzari@piedmont.org.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.08.019']
3382,32055640,Factor Xa Inhibition Reduces Coagulation Activity but Not Inflammation Among People With HIV: A Randomized Clinical Trial.,"Background


Coagulation activity among persons with HIV is associated with end-organ disease risk, but the pathogenesis is not well characterized. We tested a hypothesis that hypercoagulation contributes to disease risk, in part, via upregulation of inflammation.
Methods


Treatment effects of edoxaban (30 mg), a direct factor Xa inhibitor, vs placebo were investigated in a randomized, double-blind crossover trial among participants with HIV and viral suppression and D-dimer levels ≥100 ng/mL. During each 4-month crossover period, blood measures of coagulation, inflammation, and immune activation were assessed. Analyses of change on edoxaban vs change on placebo used linear mixed models.
Results


Forty-four participants were randomized, and 40 completed at least 1 visit during each study period. The mean age was 49 years, and the CD4+ count was 739 cells/mm 3 . Edoxaban treatment led to declines in D-dimer (44%) and thrombin-antithrombin complex (26%) but did not lower inflammatory or immune activation measures. More bruising or bleeding events occurred during edoxaban (n = 28) than during placebo or no drug periods (n = 15).
Conclusions


The direct factor Xa inhibitor edoxaban led to a substantial reduction in coagulation but no effect on inflammation or immune activation. These results do not support that hypercoagulation contributes to ongoing inflammation during chronic antiretroviral therapy-treated HIV disease.",2020,Edoxaban treatment led to declines in D-dimer (44%) and thrombin-antithrombin complex (26%) but did not lower inflammatory or immune activation measures.,"['persons with HIV', 'The mean age was 49 years, and the CD4+ count was 739 cells/mm 3 ', 'Forty-four participants were randomized, and 40 completed at least 1 visit during each study period', 'participants with HIV and viral suppression and D-dimer levels ≥100 ng/mL', 'People With HIV']","['edoxaban', 'Xa inhibitor edoxaban', 'placebo', 'Edoxaban', 'direct factor Xa inhibitor, vs placebo', 'Factor Xa Inhibition']","['Coagulation Activity', 'thrombin-antithrombin complex', 'bruising or bleeding events', 'blood measures of coagulation, inflammation, and immune activation']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0647859', 'cui_str': 'AM49'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0060323', 'cui_str': 'D-dimer fragments'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]","[{'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3653500', 'cui_str': 'Direct Factor Xa Inhibitors'}, {'cui': 'C0015520', 'cui_str': 'Factor 10A'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0052128', 'cui_str': 'AT III-protease complex'}, {'cui': 'C0009938', 'cui_str': 'Bruise'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0005768'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}]",44.0,0.57673,Edoxaban treatment led to declines in D-dimer (44%) and thrombin-antithrombin complex (26%) but did not lower inflammatory or immune activation measures.,"[{'ForeName': 'Jason V', 'Initials': 'JV', 'LastName': 'Baker', 'Affiliation': 'Hennepin Healthcare Research Institute, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Wolfson', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Tess', 'Initials': 'T', 'LastName': 'Peterson', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Micah', 'Initials': 'M', 'LastName': 'Mooberry', 'Affiliation': 'University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Gissel', 'Affiliation': 'University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Mystakelis', 'Affiliation': 'NIAID/NIH, Bethesda, Maryland, USA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Henderson', 'Affiliation': 'University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Garcia-Myers', 'Affiliation': 'Hennepin Healthcare Research Institute, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Frank S', 'Initials': 'FS', 'LastName': 'Rhame', 'Affiliation': 'Abbot Northwestern Hospital, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Schacker', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Kathleen E', 'Initials': 'KE', 'LastName': 'Brummel-Ziedins', 'Affiliation': 'University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Irini', 'Initials': 'I', 'LastName': 'Sereti', 'Affiliation': 'NIAID/NIH, Bethesda, Maryland, USA.'}, {'ForeName': 'Nigel S', 'Initials': 'NS', 'LastName': 'Key', 'Affiliation': 'University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Russell P', 'Initials': 'RP', 'LastName': 'Tracy', 'Affiliation': 'University of Vermont, Burlington, Vermont, USA.'}]",Open forum infectious diseases,['10.1093/ofid/ofaa026']
3383,31809325,Pain Response to Open Label Placebo in Induced Acute Pain in Healthy Adult Males.,"BACKGROUND


Open label placebos with patient education are effective in reducing chronic pain, and recent studies on their effect on pain have established interest in this field. Nevertheless, data on their effect on acute pain are scarce, and on hyperalgesia and allodynia, absent. This study assessed the effect of open label placebos on acute pain in healthy adult males and the influence of placebo education.
METHODS


Thirty-two healthy males were included in this prospective, randomized, assessor-blinded crossover, single-center study assessing pain intensities (via numeric rating scale), area of hyperalgesia (von Frey filament), and allodynia (dry cotton swab) in a pain model utilizing intracutaneous electrical stimulation. The authors compared the effect of intravenous open label placebo on pain compared to no treatment. The authors further examined the effect of placebo on hyperalgesia and allodynia, and the influence of education (short vs. detailed) before placebo application. Saliva cortisol concentrations were also measured.
RESULTS


Pain ratings (median, first to third quartile) were 21% lower during placebo treatment compared to no treatment, 4.0 (3.2 to 4.9) versus 5.1 (4.7 to 5.4), respectively (P = 0.001). The areas of hyperalgesia and allodynia were lower during placebo treatment compared to no treatment (hyperalgesia, 30 cm [17 to 47] vs. 55 cm [42 to 68], P = 0.003; allodynia, 24 cm [11 to 39] vs. 45 cm [31 to 62], P = 0.007). This corresponds to reductions of 47%. The extent of placebo education had no effect on pain. Saliva cortisol decreased significantly over time and was under the limit of detectability in the majority of participants in postbaseline measurements in both treatment branches. Baseline cortisol was not associated with the placebo effect or strength applied of current to reach defined pain ratings.
CONCLUSIONS


Open label placebos might play a role in multimodal analgesic concepts.",2020,"The areas of hyperalgesia and allodynia were lower during placebo treatment compared to no treatment (hyperalgesia, 30 cm [17 to 47] vs. 55 cm [42 to 68], P = 0.003; allodynia, 24 cm [11 to 39] vs. 45 cm [31 to 62], P = 0.007).","['healthy adult males', 'Healthy Adult Males', 'Thirty-two healthy males']","['placebo', 'Open Label Placebo', 'open label placebos', 'intravenous open label placebo']","['pain ratings', 'acute pain', 'Pain Response', 'Saliva cortisol concentrations', 'Saliva cortisol', 'hyperalgesia and allodynia', 'pain', 'pain intensities (via numeric rating scale), area of hyperalgesia (von Frey filament), and allodynia (dry cotton swab', 'Pain ratings']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184567', 'cui_str': 'Acute Pain'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesic Sensations'}, {'cui': 'C0458247', 'cui_str': 'Allodynia'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0222045'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C1095832', 'cui_str': 'Cotton - textile'}, {'cui': 'C1261188', 'cui_str': 'Swab (physical object)'}]",32.0,0.190986,"The areas of hyperalgesia and allodynia were lower during placebo treatment compared to no treatment (hyperalgesia, 30 cm [17 to 47] vs. 55 cm [42 to 68], P = 0.003; allodynia, 24 cm [11 to 39] vs. 45 cm [31 to 62], P = 0.007).","[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Schneider', 'Affiliation': 'From the Department for Anesthesia, Intensive Care Medicine, Prehospital Emergency Medicine and Pain Therapy, University Hospital of Basel, Basel, Switzerland.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Luethi', 'Affiliation': ''}, {'ForeName': 'Eckhard', 'Initials': 'E', 'LastName': 'Mauermann', 'Affiliation': ''}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Bandschapp', 'Affiliation': ''}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Ruppen', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003076']
3384,31526591,"Do Warmed Blankets Change Pain, Agitation, Mood or Analgesic Use Among Nursing Home Residents?","BACKGROUND


Pain, agitation, and thermal discomfort are common symptoms of older adults residing in nursing homes. Nonpharmacologic interventions are recognized as a best practice strategy for people living in nursing homes because of their low adverse effect profile and increased evidence of effectiveness. Warmed blankets have not been empirically tested for use in long-term care.
AIMS


The purpose of this quality improvement project was to describe the use of warmed blankets in a nursing home setting and determine if use was associated with changes in pain, agitation, mood, or analgesic use.
DESIGN


A pretest posttest design was used along with a comparison of intact groups.
SETTINGS


The setting was one 160-bed skilled long-term care facility.
PARTICIPANTS/SUBJECTS


There were 141 residents eligible since they did not have a condition that could be worsened by superficial heat.
METHODS


Warmed blankets were unfolded and placed over residents with pain, agitation, or thermal discomfort. Short-term pain measures included use of the Revised FACES Pain Scale, the PAINAD (Pain Assessment in Advanced Dementia) scale, and the Brief Agitation Rating Scale. Long-term measures were taken from the electronic medical record.
RESULTS


Of the 141 eligible residents, 24.1% (n = 34) received a warmed blanket over the 1- month study period. There were statistically significant decreases in both pain level and agitation among baseline, 20 minutes after application, and the subsequent shift assessments (p < .001). There were also long-term changes in the number of pain complaints (p = .040), severity of pain complaints (p = .009), and as-needed analgesic use (p = .011). There were no statistically significant differences between the treated group and comparison group on any long-term measures.
CONCLUSIONS


Warmed blankets are a low-cost intervention with a high potential for bringing comfort to nursing home residents.",2019,"There were statistically significant decreases in both pain level and agitation among baseline, 20 minutes after application, and the subsequent shift assessments (p < .001).","['Nursing Home Residents', '141 residents eligible since they did not have a condition that could be worsened by superficial heat', '141 eligible residents, 24.1% (n\xa0=\xa034', 'older adults residing in nursing homes']",['warmed blankets'],"['Revised FACES Pain Scale, the PAINAD (Pain Assessment in Advanced Dementia) scale, and the Brief Agitation Rating Scale', 'Pain, Agitation, Mood or Analgesic Use', 'pain level and agitation', 'severity of pain complaints', 'number of pain complaints', 'pain, agitation, mood, or analgesic use']","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}]","[{'cui': 'C0179330', 'cui_str': 'Blanket, device (physical object)'}]","[{'cui': 'C0015468', 'cui_str': 'Face Pain'}, {'cui': 'C0222045'}, {'cui': 'C0030198', 'cui_str': 'Nociception Tests'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",141.0,0.0625866,"There were statistically significant decreases in both pain level and agitation among baseline, 20 minutes after application, and the subsequent shift assessments (p < .001).","[{'ForeName': 'Christine R', 'Initials': 'CR', 'LastName': 'Kovach', 'Affiliation': 'Research Office, Ovation Communities, Milwaukee, Wisconsin. Electronic address: ckovach@Ovation.org.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Putz', 'Affiliation': 'Research Office, Ovation Communities, Milwaukee, Wisconsin.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Guslek', 'Affiliation': 'Research Office, Ovation Communities, Milwaukee, Wisconsin.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'McInnes', 'Affiliation': 'Research Office, Ovation Communities, Milwaukee, Wisconsin.'}]",Pain management nursing : official journal of the American Society of Pain Management Nurses,['10.1016/j.pmn.2019.07.002']
3385,32028458,Exercise Training Rapidly Increases Hepatic Insulin Extraction in NAFLD.,"PURPOSE


We aimed to determine the immediacy of exercise intervention on liver-specific metabolic processes in nonalcoholic fatty liver disease.
METHODS


We undertook a short-term (7-d) exercise training study (60 min·d treadmill walking at 80%-85% of maximal heart rate) in obese adults (N = 13, 58 ± 3 yr, 34.3 ± 1.1 kg·m, >5% hepatic lipid by H-magnetic resonance spectroscopy). Insulin sensitivity index was estimated by oral glucose tolerance test using the Soonthorpun model. Hepatic insulin extraction (HIE) was calculated as the molar difference in area under the curve (AUC) for insulin and C-peptide (HIE = 1 - (AUCInsulin/AUCC-Pep)).
RESULTS


The increases in HIE, V˙O2max, and insulin sensitivity index after the intervention were 9.8%, 9.8%, and 34%, respectively (all, P < 0.05). Basal fat oxidation increased (pre: 47 ± 6 mg·min vs post: 65 ± 6 mg·min, P < 0.05) and carbohydrate oxidation decreased (pre: 160 ± 20 mg·min vs post: 112 ± 15 mg·min, P < 0.05) with exercise training. After the intervention, HIE correlated positively with adiponectin (r = 0.56, P < 0.05) and negatively with TNF-α (r = -0.78, P < 0.001).
CONCLUSIONS


By increasing HIE along with peripheral insulin sensitivity, aerobic exercise training rapidly reverses some of the underlying physiological mechanisms associated with nonalcoholic fatty liver disease, in a weight loss-independent manner. This reversal could potentially act through adipokine-related pathways.",2020,"The increase in HIE, VO2max and ISI following the intervention was 9.8%, 9.8% and 34%, respectively (all P<0.05).","['obese adults (N=13, 58±3 years, 34.3±1.1 kg/m, >5% hepatic lipid by H-MR spectroscopy', 'Non-alcoholic fatty liver disease (NAFLD']","['Exercise Training', 'short-term (7-day) exercise training', 'carbohydrate oxidation', 'exercise intervention', 'exercise training', 'aerobic exercise training']","['Basal fat oxidation', 'Hepatic insulin extraction (HIE', 'HIE, VO2max and ISI', 'Insulin sensitivity (ISI', 'Hepatic Insulin Extraction']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0024487', 'cui_str': 'MR Spectroscopy'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}]",,0.0338532,"The increase in HIE, VO2max and ISI following the intervention was 9.8%, 9.8% and 34%, respectively (all P<0.05).","[{'ForeName': 'Adithya', 'Initials': 'A', 'LastName': 'Hari', 'Affiliation': 'Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'CiarÀn E', 'Initials': 'CE', 'LastName': 'Fealy', 'Affiliation': 'Nutrition and Movement Sciences, Maastricht University, Maastricht, The NETHERLANDS.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Axelrod', 'Affiliation': 'Integrated Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, Baton Rouge, LA.'}, {'ForeName': 'Jacob M', 'Initials': 'JM', 'LastName': 'Haus', 'Affiliation': 'Human Bioenergetics Laboratory, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Flask', 'Affiliation': 'Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'Arthur J', 'Initials': 'AJ', 'LastName': 'McCullough', 'Affiliation': 'Department of Gastroenterology and Hepatology, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Kirwan', 'Affiliation': 'Case Western Reserve University, Cleveland, OH.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002273']
3386,32034403,Pretreatment Prevotella-to-Bacteroides ratio and salivary amylase gene copy number as prognostic markers for dietary weight loss.,"BACKGROUND


The inconsistent link observed between salivary amylase gene copy number (AMY1 CN) and weight management is likely modified by diet and microbiome.
OBJECTIVE


Based on analysis of a previously published study, we investigated the hypothesis that interaction between diet, Prevotella-to-Bacteriodes ratio (P/B ratio), and AMY1 CN influence weight change.
METHODS


Sixty-two people with increased waist circumference were randomly assigned to receive an ad libitum New Nordic Diet (NND) high in dietary fiber, whole grain, intrinsic sugars, and starch or an Average Danish (Western) Diet (ADD) for 26 weeks. All foods were provided free of charge. Before subjects were randomly assigned to receive the NND or ADD diet, blood and fecal samples were collected, from which AMY1 CN and P/B ratio, respectively, were determined. Body weight change was described by using linear mixed models, including biomarker [log10(P/B ratio) and/or AMY1 CN] diet-group interactions.
RESULTS


Baseline means ± SDs of log10(P/B ratio) and AMY1 CN were -2.1 ± 1.8 and 6.6 ± 2.4, respectively. Baseline P/B ratio predicted a 0.99-kg/unit (95% CI: 0.40, 1.57; n = 54; P < 0.001) higher weight loss for those subjects on the NND compared with those on the ADD diet, whereas AMY1 CN was not found to predict weight loss differences between the NND and ADD groups [0.05 kg/CN (95% CI: -0.40, 0.51; n = 54; P = 0.83)]. However, among subjects with low AMY1 CN (<6.5 copies), baseline P/B ratio predicted a 2.12-kg/unit (95% CI: 1.37, 2.88; n = 30; P < 0.001) higher weight loss for the NND group than the ADD group. No such differences in weight loss were found among subjects in both groups with high AMY1 CN [-0.17 kg/unit (95% CI: -1.01, 0.66; n = 24; P = 0.68)].
CONCLUSIONS


The combined use of low AMY1 CN and pretreatment P/B ratio for weight loss prediction led to highly individualized weight loss results with the introduction of more fiber, whole grain, intrinsic sugars, and starch in the diet. These preliminary observations suggest that more undigested starch reaches the colon in individuals with low AMY1 CN, and that the fate of this starch depends on the gut microbiota composition. This trial was registered at clinicaltrials.gov as NCT01195610.",2020,"No such differences in weight loss were found among subjects in both groups with high AMY1 CN [-0.17 kg/unit (95% CI: -1.01, 0.66; n = 24; P = 0.68)].
",['Sixty-two people with increased waist circumference'],"['low AMY1 CN', 'ad libitum New Nordic Diet (NND) high in dietary fiber, whole grain, intrinsic sugars, and starch or an Average Danish (Western) Diet (ADD']","['weight loss', 'Body weight change', 'Baseline means\xa0±\xa0SDs of log10(P/B ratio) and AMY1 CN', 'weight loss differences']","[{'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0012173', 'cui_str': 'Dietary Fiber'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0439674', 'cui_str': 'Intrinsic (qualifier value)'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",62.0,0.040229,"No such differences in weight loss were found among subjects in both groups with high AMY1 CN [-0.17 kg/unit (95% CI: -1.01, 0.66; n = 24; P = 0.68)].
","[{'ForeName': 'Mads F', 'Initials': 'MF', 'LastName': 'Hjorth', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, Faculty of Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Christensen', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, Faculty of Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Larsen', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, Faculty of Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Henrik M', 'Initials': 'HM', 'LastName': 'Roager', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, Faculty of Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Lukasz', 'Initials': 'L', 'LastName': 'Krych', 'Affiliation': 'Food Science, Faculty of Science, University of Copenhagen, Denmark.'}, {'ForeName': 'Witold', 'Initials': 'W', 'LastName': 'Kot', 'Affiliation': 'Department of Plant and Environmental Sciences, Faculty of Science, University of Copenhagen, Denmark.'}, {'ForeName': 'Dennis S', 'Initials': 'DS', 'LastName': 'Nielsen', 'Affiliation': 'Food Science, Faculty of Science, University of Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ritz', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, Faculty of Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, Faculty of Sciences, University of Copenhagen, Denmark.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa007']
3387,32034849,STRAWB2 (Stress and Wellbeing After Childbirth): a randomised controlled trial of targeted self-help materials to prevent post-traumatic stress disorder following childbirth.,"OBJECTIVES


To test whether providing psychological self-help materials would significantly lower the incidence of post-traumatic stress disorder (PTSD) at 6-12 weeks postnatally.
DESIGN


Open-label randomised controlled trial, with blinded outcome assessment.
SETTING


Community midwifery services in two National Health Service (NHS) trusts in the North West.
SAMPLE


A cohort of 2419 women receiving normal NHS postnatal care.
METHODS


Midwives screened women for traumatic birth experience; 678 women who screened positively (28.1%) were randomly allocated to self-help with usual care (n = 336) or to usual care alone (n = 342). The self-help materials were a leaflet and online film designed to prevent the development of PTSD after trauma exposure through explaining how to manage early psychological responses.
MAIN OUTCOME MEASURE


The primary outcome was a composite of diagnostic and subdiagnostic PTSD at 6-12 weeks postnatally using the gold-standard Clinician-Administered PTSD Scale (CAPS-5) interview.
RESULTS


Of the 678 women correctly randomised plus the nine women randomised in error, 478 (70.5%) were followed up. Diagnostic or subdiagnostic PTSD rates at follow-up did not differ between groups who received self-help (26.7%, 65/243) or usual care alone (26.2%, 64/244) (intention-to-treat analysis: RR 1.02, 95% CI 0.68-1.53). Findings remained consistent in the per-protocol analysis (RR 1.04, 95% CI 0.85-1.27). Women viewed the materials very positively. There were no adverse effects. Health economic micro-costing indicated implementation would be very low cost.
CONCLUSIONS


Many women experience a traumatic birth and risk developing PTSD, but self-help strategies without professional support are insufficient and should not be routinely introduced.
TWEETABLE ABSTRACT


Self-help information alone does not reduce the number of women developing PTSD after a traumatic childbirth.",2020,"Diagnostic or sub-diagnostic PTSD rates at follow-up did not differ between groups who received self-help (26.7%, 65/243) or usual care alone (26.2%, 64/244) (ITT analysis: relative risk (RR) 1.02, 95% confidence interval (CI) 0.68 to 1.53).","['Community midwifery services in two North West NHS Trusts', '678 women who screened positive (28.1', 'Midwives screened women for traumatic birth experience', '478 of 678 (70.5%) correctly randomised women and 9 randomised in error were followed up', '2419 women receiving usual NHS postnatal care']",['self-help with usual care (n=336) or usual care alone'],"['composite of diagnostic and sub-diagnostic PTSD', 'adverse effects', 'Diagnostic or sub-diagnostic PTSD rates', 'gold standard Clinician Administered PTSD Interview (CAPS-5']","[{'cui': 'C4075525', 'cui_str': 'Community midwifery service (qualifier value)'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0026083', 'cui_str': 'Midwife'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0032782', 'cui_str': 'Postpartum Care'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}]",2419.0,0.17233,"Diagnostic or sub-diagnostic PTSD rates at follow-up did not differ between groups who received self-help (26.7%, 65/243) or usual care alone (26.2%, 64/244) (ITT analysis: relative risk (RR) 1.02, 95% confidence interval (CI) 0.68 to 1.53).","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Slade', 'Affiliation': 'Department of Psychological Sciences, Institute of Health and Life Sciences, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'West', 'Affiliation': 'Department of Psychological Sciences, Institute of Health and Life Sciences, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Thomson', 'Affiliation': 'School of Community Health and Midwifery, University of Central Lancashire, Preston, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lane', 'Affiliation': 'Centre for Medical Statistics and Health Evaluation, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Spiby', 'Affiliation': 'School of Health Sciences, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'R T', 'Initials': 'RT', 'LastName': 'Edwards', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Gwynedd, UK.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Charles', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Gwynedd, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Garrett', 'Affiliation': 'Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Flanagan', 'Affiliation': 'Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Treadwell', 'Affiliation': 'Birth Trauma Association, Winchester, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hayden', 'Affiliation': ""Liverpool Women's Hospital Foundation Trust, Liverpool, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Weeks', 'Affiliation': ""Department of Women's and Children's Health, University of Liverpool, Liverpool, UK.""}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16163']
3388,32030734,The impact of fluid optimisation before induction of anaesthesia on hypotension after induction.,"Intra-operative hypotension is a known predictor of adverse events and poor outcomes following major surgery. Hypotension often occurs on induction of anaesthesia, typically attributed to hypovolaemia and the haemodynamic effects of anaesthetic agents. We assessed the efficacy of fluid optimisation for reducing the incidence of hypotension on induction of anaesthesia. This prospective trial enrolled 283 patients undergoing radical cystectomy and randomly allocated them to goal-directed fluid therapy (n = 142) or standard fluid therapy (n = 141). Goal-directed fluid therapy patients received fluid optimisation based on stroke volume response to passive leg raise before induction; those with positive passive leg raise received intravenous crystalloid fluid boluses until stroke volume was optimised. Baseline mean arterial pressure was measured on the morning of surgery and on arriving in the operating theatre. This post-hoc analysis defined haemodynamic instability as either a > 30% relative drop in mean arterial pressure compared with baseline or absolute mean arterial pressure < 55 mmHg, within 15 min of induction. Forty-two (30%) goal-directed fluid therapy patients underwent fluid optimisation after finding an intravascular fluid deficit via passive leg raise testing; 106 (75%) goal-directed fluid therapy and 112 (79%) standard fluid therapy patients met criteria for haemodynamic instability. There was no significant difference in the incidence of haemodynamic instability between the goal-directed fluid therapy and standard fluid therapy groups using absolute mean arterial pressure drop below 55 mmHg (p = 0.58) or using pre-surgical testing or pre-surgical mean arterial pressure values as baseline (p = 0.21, p = 0.89, respectively); however, the difference in the incidence of haemodynamic instability was significant using the operating theatre baseline mean arterial pressure (p = 0.004). We conclude that fluid optimisation before induction of general anaesthesia did not significantly impact haemodynamic instability.",2020,There was no significant difference in the incidence of haemodynamic instability between the goal-directed fluid therapy and standard fluid therapy groups using absolute mean arterial pressure drop below 55 mmHg (p = 0.58) or using pre-surgical testing or pre-surgical mean arterial pressure values as baseline (,"['283 patients undergoing', 'patients met criteria for haemodynamic instability']","['goal-directed fluid therapy (n\xa0=\xa0142) or standard fluid therapy', 'radical cystectomy', 'standard fluid therapy']","['haemodynamic instability', 'Baseline mean arterial pressure', 'operating theatre baseline mean arterial pressure', 'mean arterial pressure']","[{'cui': 'C4708786', 'cui_str': 'Two hundred and eighty-three'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0948268', 'cui_str': 'Hemodynamic instability'}]","[{'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0016286', 'cui_str': 'Fluid Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0194401', 'cui_str': 'Total resection of urinary bladder (procedure)'}]","[{'cui': 'C0948268', 'cui_str': 'Hemodynamic instability'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0029064', 'cui_str': 'Operating Room'}]",283.0,0.125273,There was no significant difference in the incidence of haemodynamic instability between the goal-directed fluid therapy and standard fluid therapy groups using absolute mean arterial pressure drop below 55 mmHg (p = 0.58) or using pre-surgical testing or pre-surgical mean arterial pressure values as baseline (,"[{'ForeName': 'A I', 'Initials': 'AI', 'LastName': 'Khan', 'Affiliation': 'Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fischer', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, Memorial Sloan Kettering Cancer Centre, New York, NY, USA.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Pedoto', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, Memorial Sloan Kettering Cancer Centre, New York, NY, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Seier', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Centre, New York, NY, USA.'}, {'ForeName': 'K S', 'Initials': 'KS', 'LastName': 'Tan', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Centre, New York, NY, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Dalbagni', 'Affiliation': 'Department of Surgery, Urology Service, Memorial Sloan Kettering Cancer Centre, New York, NY, USA.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Donat', 'Affiliation': 'Department of Surgery, Urology Service, Memorial Sloan Kettering Cancer Centre, New York, NY, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Arslan-Carlon', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, Memorial Sloan Kettering Cancer Centre, New York, NY, USA.'}]",Anaesthesia,['10.1111/anae.14984']
3389,32030990,Sociodemographic Correlates of Food Insecurity Among New York City Tobacco Users.,"PURPOSE


To identify rates and sociodemographic correlates of food insecurity among low-income smokers.
DESIGN


Cross-sectional analysis of baseline survey data from a randomized controlled trial (N = 403) testing a smoking cessation intervention for low-income smokers.
SETTING


Two safety-net hospitals in New York City.
SAMPLE


Current smokers with annual household income <200% of the federal poverty level.
MEASURES


Food insecurity was measured using the United States Department of Agriculture 6-item food security module. Participant sociodemographics were assessed by self-reported survey responses.
ANALYSIS


We used frequencies to calculate the proportion of smokers experiencing food insecurity and multivariable logistic regression to identify factors associated with being food insecure.
RESULTS


Fifty-eight percent of participants were food insecure, with 29% reporting very high food insecurity. Compared to married participants, separated, widowed, or divorced participants were more likely to be food insecure (adjusted odds ratio [AOR] = 2.33, 95% confidence interval [CI]: 1.25-4.33), as were never married participants (AOR = 2.81, 95% CI: 1.54-5.14).
CONCLUSIONS


Health promotion approaches that target multiple health risks (eg, smoking  and  food access) may be needed for low-income populations. Interventions which seek to alleviate food insecurity may benefit from targeting socially isolated smokers.",2020,"Compared to married participants, separated, widowed, or divorced participants were more likely to be food insecure (adjusted odds ratio [AOR] =","['SAMPLE\n\n\nCurrent smokers with annual household income', 'low-income smokers', 'New York City Tobacco Users', 'Two safety-net hospitals in New York City']",['smoking cessation intervention'],['Sociodemographic Correlates of Food Insecurity'],"[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C3241966'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0557163', 'cui_str': 'Household income (observable entity)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C3853727', 'cui_str': 'Tobacco user (finding)'}, {'cui': 'C3661443', 'cui_str': 'Safety-net Hospitals'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C3494174', 'cui_str': 'Food Insecurity'}]",403.0,0.119324,"Compared to married participants, separated, widowed, or divorced participants were more likely to be food insecure (adjusted odds ratio [AOR] =","[{'ForeName': 'Christina N', 'Initials': 'CN', 'LastName': 'Wysota', 'Affiliation': 'New York University Grossman School of Medicine, New York, NY, USA.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Sherman', 'Affiliation': 'New York University Grossman School of Medicine, New York, NY, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Vargas', 'Affiliation': 'New York University Grossman School of Medicine, New York, NY, USA.'}, {'ForeName': 'Erin S', 'Initials': 'ES', 'LastName': 'Rogers', 'Affiliation': 'New York University Grossman School of Medicine, New York, NY, USA.'}]",American journal of health promotion : AJHP,['10.1177/0890117120904002']
3390,31470942,Clinical and experimental evaluation of new back-flow hydrodissection technique.,"PURPOSE


To assess the efficacy and safety of a new technique, back-flow hydrodissection.
SETTING


Hirota Eye Clinic, Yamaguchi, and Department of Ophthalmology, University of Tsukuba, Ibaraki, Japan.
DESIGN


Prospective case series and experimental study.
METHODS


For back-flow hydrodissection, the irrigation line was connected to the aspiration port of an irrigation/aspiration handpiece using a female-female connector with the irrigation port open. The balanced salt solution was irrigated from the aspiration tip opening with constant pressure, hydrodissection was performed, and the excess fluid was evacuated via the sleeve lumen. In a clinical study, 200 eyes were randomly assigned to conventional hydrodissection with an irrigation cannula or back-flow hydrodissection. In experimental studies, intraocular pressure (IOP) fluctuation and fluid dynamics in the anterior and posterior chamber were evaluated in porcine eyes.
RESULTS


The lens became freely mobile in the capsular bag in 99 (99%) of 100 eyes and in 96 (96%) of 100 eyes in the back-flow hydrodissection group and conventional hydrodissection group, respectively (P = .369). There were no between-group differences in any other surgery-related parameters, including surgical time and the complication rate. In porcine eyes, conventional hydrodissection induced a significantly larger increase in IOP than back-flow hydrodissection (P < .0001). Conventional hydrodissection immediately washed out fluorescein-stained ophthalmic viscosurgical device (OVD) from the anterior chamber, while there was little leakage of OVD from the eye with back-flow hydrodissection. The endoscopic view showed that conventional hydrodissection induced rapid and severe bulging of the posterior capsule; however, bulging was gentle and mild with back-flow hydrodissection.
CONCLUSION


Back-flow hydrodissection was safe and effective in disengaging the lens from the capsule, ensuring a freely mobile lens.",2019,"In porcine eyes, conventional hydrodissection induced a significantly larger increase in IOP than back-flow hydrodissection (P < .0001).","['Hirota Eye Clinic, Yamaguchi, and Department of Ophthalmology, University of Tsukuba, Ibaraki, Japan', 'For back-flow hydrodissection', '200 eyes']","['Back-flow hydrodissection', 'conventional hydrodissection with an irrigation cannula or back-flow hydrodissection', 'Conventional hydrodissection immediately washed out fluorescein-stained ophthalmic viscosurgical device (OVD']","['intraocular pressure (IOP) fluctuation and fluid dynamics', 'IOP', 'surgical time and the complication rate', 'efficacy and safety']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C1318787', 'cui_str': 'Fluorescein stain'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C2363846', 'cui_str': 'Intraocular pressure fluctuation'}, {'cui': 'C2936194', 'cui_str': 'Fluid Dynamics'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",200.0,0.0258306,"In porcine eyes, conventional hydrodissection induced a significantly larger increase in IOP than back-flow hydrodissection (P < .0001).","[{'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Hirota', 'Affiliation': 'Hirota Eye Clinic, Ibaraki, Japan.'}, {'ForeName': 'Kazuomi', 'Initials': 'K', 'LastName': 'Yasuda', 'Affiliation': 'Musashikoganei Sakura Eye Clinic, Ibaraki, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Tane Memorial Eye Hospital, Ibaraki, Japan.'}, {'ForeName': 'Fumiki', 'Initials': 'F', 'LastName': 'Okamoto', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Sujin', 'Initials': 'S', 'LastName': 'Hoshi', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Tomoya', 'Initials': 'T', 'LastName': 'Murakami', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Oshika', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan. Electronic address: oshika@eye.ac.'}]",Journal of cataract and refractive surgery,['10.1016/j.jcrs.2019.05.016']
3391,31003911,"Atezolizumab with or without cobimetinib versus regorafenib in previously treated metastatic colorectal cancer (IMblaze370): a multicentre, open-label, phase 3, randomised, controlled trial.","BACKGROUND


Microsatellite-stable metastatic colorectal cancer is typically unresponsive to immunotherapy. This phase 3 study was designed to assess atezolizumab plus cobimetinib in metastatic colorectal cancer. Here, we report the comparison of atezolizumab plus cobimetinib or atezolizumab monotherapy versus regorafenib in the third-line setting.
METHODS


IMblaze 370 is a multicentre, open-label, phase 3, randomised, controlled trial, done at 73 academic medical centres and community oncology practices in 11 countries. Patients aged at least 18 years with unresectable locally advanced or metastatic colorectal cancer, baseline Eastern Cooperative Oncology Group performance status of 0-1, and disease progression on or intolerance to at least two previous systemic chemotherapy regimens were enrolled. We used permuted-block randomisation (block size four) to assign patients (2:1:1) via an interactive voice and web response system to atezolizumab (840 mg intravenously every 2 weeks) plus cobimetinib (60 mg orally once daily for days 1-21 of a 28-day cycle), atezolizumab monotherapy (1200 mg intravenously every 3 weeks), or regorafenib (160 mg orally once daily for days 1-21 of a 28-day cycle). Stratification factors were extended RAS status (wild-type vs mutant) and time since diagnosis of first metastasis (<18 months vs ≥18 months). Recruitment of patients with high microsatellite instability was capped at 5%. The primary endpoint was overall survival in the intention-to-treat population. Safety was assessed in the population of patients who received at least one dose of their assigned treatment. IMblaze370 is ongoing and is registered with ClinicalTrials.gov, number NCT02788279.
FINDINGS


Between July 27, 2016, and Jan 19, 2017, 363 patients were enrolled (183 patients in the atezolizumab plus cobimetinib group, 90 in the atezolizumab group, and 90 in the regorafenib group). At data cutoff (March 9, 2018), median follow-up was 7·3 months (IQR 3·7-13·6). Median overall survival was 8·87 months (95% CI 7·00-10·61) with atezolizumab plus cobimetinib, 7·10 months (6·05-10·05) with atezolizumab, and 8·51 months (6·41-10·71) with regorafenib; the hazard ratio was 1·00 (95% CI 0·73-1·38; p=0·99) for the combination versus regorafenib and 1·19 (0·83-1·71; p=0·34) for atezolizumab versus regorafenib. Grade 3-4 adverse events were reported in 109 (61%) of 179 patients in the atezolizumab plus cobimetinib group, 28 (31%) of 90 in the atezolizumab group, and 46 (58%) of 80 in the regorafenib group. The most common all-cause grade 3-4 adverse events in the combination group were diarrhoea (20 [11%] of 179), anaemia (ten [6%]), increased blood creatine phosphokinase (12 [7%]), and fatigue (eight [4%]). Serious adverse events were reported in 71 (40%) of 179 patients in the combination group, 15 (17%) of 90 in the atezolizumab group, and 18 (23%) of 80 in the regorafenib group. Two treatment-related deaths occurred in the combination group (sepsis) and one in the regorafenib group (intestinal perforation).
INTERPRETATION


IMblaze370 did not meet its primary endpoint of improved overall survival with atezolizumab plus cobimetinib or atezolizumab versus regorafenib. The safety of atezolizumab plus cobimetinib was consistent with those of the individual drugs. These results underscore the challenge of expanding the benefit of immunotherapy to patients whose tumours have lower baseline levels of immune inflammation, such as those with microsatellite-stable metastatic colorectal cancer.
FUNDING


F Hoffmann-La Roche Ltd/Genentech Inc.",2019,"Median overall survival was 8·87 months (95% CI 7·00-10·61) with atezolizumab plus cobimetinib, 7·10 months (6·05-10·05) with atezolizumab, and 8·51 months (6·41-10·71) with regorafenib; the hazard ratio was 1·00 (95% CI 0·73-1·38; p=0·99) for the combination versus regorafenib and 1·19 (0·83-1·71; p=0·34) for atezolizumab versus regorafenib.","['73 academic medical centres and community oncology practices in 11 countries', 'Patients aged at least 18 years with unresectable locally advanced or metastatic colorectal cancer, baseline Eastern Cooperative Oncology Group performance status of 0-1, and disease progression on or intolerance to at least two previous systemic chemotherapy regimens were enrolled', 'Between July 27, 2016, and Jan 19, 2017, 363 patients were enrolled (183 patients in the atezolizumab plus cobimetinib group, 90 in the atezolizumab group, and 90 in the regorafenib group', 'metastatic colorectal cancer', 'previously treated metastatic colorectal cancer (IMblaze370']","['Atezolizumab with or without cobimetinib versus regorafenib', 'atezolizumab plus cobimetinib', 'IMblaze370', 'regorafenib', 'atezolizumab plus cobimetinib or atezolizumab monotherapy versus regorafenib', 'permuted-block randomisation (block size four) to assign patients (2:1:1) via an interactive voice and web response system to atezolizumab', 'atezolizumab versus regorafenib', 'cobimetinib', 'atezolizumab', 'atezolizumab monotherapy']","['anaemia', 'Grade 3-4 adverse events', 'blood creatine phosphokinase', 'diarrhoea', 'deaths', 'Median overall survival', 'overall survival', 'Safety', 'Serious adverse events']","[{'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4049146', 'cui_str': 'Cobimetinib'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C4049146', 'cui_str': 'Cobimetinib'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0853165', 'cui_str': 'Blood creatine phosphokinase'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",363.0,0.306777,"Median overall survival was 8·87 months (95% CI 7·00-10·61) with atezolizumab plus cobimetinib, 7·10 months (6·05-10·05) with atezolizumab, and 8·51 months (6·41-10·71) with regorafenib; the hazard ratio was 1·00 (95% CI 0·73-1·38; p=0·99) for the combination versus regorafenib and 1·19 (0·83-1·71; p=0·34) for atezolizumab versus regorafenib.","[{'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Eng', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Tae Won', 'Initials': 'TW', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, University of Ulsan, Seoul, Korea.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Bendell', 'Affiliation': 'Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN, USA.'}, {'ForeName': 'Guillem', 'Initials': 'G', 'LastName': 'Argilés', 'Affiliation': ""Vall d'Hebrón Institute of Oncology, Vall d'Hebrón University Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Niall C', 'Initials': 'NC', 'LastName': 'Tebbutt', 'Affiliation': 'Medical Oncology, Austin Health, Heidelberg, VIC, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Di Bartolomeo', 'Affiliation': 'Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': 'University Hospital of Pisa, Pisa, Italy.'}, {'ForeName': 'Marwan', 'Initials': 'M', 'LastName': 'Fakih', 'Affiliation': 'City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kozloff', 'Affiliation': 'University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Neil H', 'Initials': 'NH', 'LastName': 'Segal', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Sobrero', 'Affiliation': 'IRCCS Ospedale San Martino IST, Genova, Italy.'}, {'ForeName': 'Yibing', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Genentech Inc, South San Francisco, CA, USA.'}, {'ForeName': 'Ilsung', 'Initials': 'I', 'LastName': 'Chang', 'Affiliation': 'Genentech Inc, South San Francisco, CA, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Uyei', 'Affiliation': 'Genentech Inc, South San Francisco, CA, USA.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Roberts', 'Affiliation': 'Genentech Inc, South San Francisco, CA, USA.'}, {'ForeName': 'Fortunato', 'Initials': 'F', 'LastName': 'Ciardiello', 'Affiliation': 'Department of Precision Medicine, Università degli Studi della Campania Luigi Vanvitelli, Naples, Italy. Electronic address: fortunato.ciardiello@unicampania.it.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30027-0']
3392,31479068,"Effects of open-label placebo on pain, functional disability, and spine mobility in patients with chronic back pain: a randomized controlled trial.","Chronic back pain (CBP) is a major global health problem, while its treatment is hampered by a lack of efficacy and restricted safety profile of common frontline therapies. The present trial aims to determine whether a 3-week open-label placebo treatment reduces pain intensity and subjective and objective functional disability in patients with CBP. This randomized controlled trial, following a pretest-posttest design, enrolled 127 patients with CBP (pain duration >12 weeks) from the Back Pain Center, Neurology, University Hospital Essen, Germany. Patients randomized to the open-label placebo group received a 3-week open-label placebo treatment. Patients in the treatment as usual (TAU) group received no intervention. Both groups continued TAU. Primary outcome was the change in pain intensity. Secondary outcomes included patient-reported functional disability and objective measures of spine mobility and depression, anxiety, and stress. One hundred twenty two patients with CBP were randomized to the open-label placebo group (N = 63) or TAU group (N = 59). Open-label placebo application led to a larger reduction of pain intensity (-0.62 ± 0.23 vs 0.11 ± 0.17, all M ± SE, P = 0.001, d = -0.44) as well as patient-reported functional disability (3.21 ± 1.59 vs 0.65 ± 1.15, P = 0.020, d = -0.45) and depression scores (-1.07 ± 0.55 vs 0.37 ± 0.39, P = 0.010, d = -0.50) compared with TAU only. Open-label placebo treatment did not affect objective mobility parameters, anxiety and stress. Our study demonstrates that a 3-week open-label placebo treatment is safe, well tolerated and reduces pain, disability, and depressive symptoms in CBP. Trial registration: German Clinical Trials Register, DRKS00012712.",2019,"Open-label placebo application led to a larger reduction of pain intensity (-0.62±0.23 vs. 0.11±0.17, all M ± SE, p=.001, d=-0.44) as well as patient-reported functional disability (3.21±1.59 vs. 0.65±1.15, p=.020, d=-0.45) and depression scores (-1.07±0.55 vs. 0.37±0.39, p=.010, d=-0.50) compared to treatment as usual only.","['chronic back pain patients', '122 chronic back pain patients', 'chronic back pain', 'enrolled 127 chronic back pain patients (pain duration > 12 weeks) from the Back Pain Center, Neurology, University Hospital Essen, Germany']","['3-week open-label placebo treatment', 'Open-label placebo', 'open-label placebo', 'OLP']","['pain intensity, and subjective and objective functional disability', 'pain intensity', 'safe, well tolerated and reduces pain, disability and depressive symptoms', 'objective mobility parameters, anxiety and stress', 'change in pain intensity', 'patient-reported functional disability, objective measures of spine mobility and depression, anxiety and stress', 'functional disability', 'depression scores', 'pain, functional disability and spine mobility']","[{'cui': 'C0740418', 'cui_str': 'Chronic back pain (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1286140', 'cui_str': 'Measure of spine'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}]",127.0,0.298589,"Open-label placebo application led to a larger reduction of pain intensity (-0.62±0.23 vs. 0.11±0.17, all M ± SE, p=.001, d=-0.44) as well as patient-reported functional disability (3.21±1.59 vs. 0.65±1.15, p=.020, d=-0.45) and depression scores (-1.07±0.55 vs. 0.37±0.39, p=.010, d=-0.50) compared to treatment as usual only.","[{'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Kleine-Borgmann', 'Affiliation': ''}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Schmidt', 'Affiliation': ''}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hellmann', 'Affiliation': ''}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Bingel', 'Affiliation': ''}]",Pain,['10.1097/j.pain.0000000000001683']
3393,32019557,The effect of low central venous pressure on hepatic surgical field bleeding and serum lactate in patients undergoing partial hepatectomy: a prospective randomized controlled trial.,"BACKGROUND


This prospective randomized controlled study was designed to evaluate the effect of fluid restriction alone versus fluid restriction + low central venous pressure (CVP) on hepatic surgical field bleeding, intraoperative blood loss, and the serum lactate concentration in patients undergoing partial hepatectomy.
METHODS


One hundred forty patients undergoing partial hepatectomy with intraoperative portal triad clamping were randomized into a fluid restriction group (Group F) or fluid restriction + low CVP group (Group L). Both groups received limited fluid infusion before the liver lesions were removed. Ephedrine was administered if the systolic blood pressure (SBP) decreased to <90 mmHg for 1 min. When the urine output was <20 ml/h or the SBP was <90 mmHg for 1 min more than three times, an additional 200 ml of crystalline solution was quickly infused within 10 min. In addition to fluid restriction, patients in Group L received continuous nitroglycerin and esmolol infusion to maintain a low CVP. The duration of portal triad clamping, frequency of additional fluid infusion, frequency of ephedrine administration, intraoperative blood loss, extent of liver resection, and bleeding score of the hepatic surgical field were recorded. Arterial blood gas analysis was performed before anesthesia (T1), after liver dissection and immediately before liver resection (T2), 10 min after removal of the liver lesion (T3), and before the patient was discharged from the postanesthesia care unit (T4).
RESULTS


Being in the fluid restriction Group (Group F) (odds ratio = 5.04) and cirrhosis (odds ratio = 3.28) were risk factors for hepatic surgical field bleeding. Factors contributing to intraoperative blood loss were the operation time, duration of portal triad clamping, and extent of resection. No significant between-group difference was observed for blood loss or blood transfusion. The serum lactate concentration peaked at T3 in both groups.
CONCLUSIONS


Maintaining a lower CVP during hepatectomy provides an optimal surgical field but has no significant effect on intraoperative blood loss. Moreover, lower CVP does not increase the serum lactate concentration.
TRIAL REGISTRATION


""A comparative study of the effect fluid restriction and low CVP pressure on the oozing of blood in liver wounds and blood lactate in patients undergoing partial hepatectomy"" was prospectively registered as a trial (registration number: ChiCTR-INR-17014172, date of registration: 27 December 2017).",2020,"RESULTS


Being in the fluid restriction Group (Group F) (odds ratio = 5.04) and cirrhosis (odds ratio = 3.28) were risk factors for hepatic surgical field bleeding.","['One hundred forty patients undergoing partial hepatectomy with intraoperative portal triad clamping', 'patients undergoing partial hepatectomy']","['Ephedrine', 'nitroglycerin and esmolol', 'low central venous pressure', 'fluid restriction alone versus fluid restriction + low central venous pressure (CVP', 'fluid restriction and low CVP pressure', 'fluid restriction group (Group F) or fluid restriction + low CVP group (Group L']","['serum lactate concentration', 'Arterial blood gas analysis', 'systolic blood pressure (SBP', 'duration of portal triad clamping, frequency of additional fluid infusion, frequency of ephedrine administration, intraoperative blood loss, extent of liver resection, and bleeding score of the hepatic surgical field', 'intraoperative blood loss', 'blood loss or blood transfusion']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0193398', 'cui_str': 'Partial hepatectomy (procedure)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0227514', 'cui_str': 'Portal triad structure'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}]","[{'cui': 'C0014479', 'cui_str': 'Ephedrine'}, {'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}, {'cui': 'C0116569', 'cui_str': 'esmolol'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0428640', 'cui_str': 'Central venous pressure (observable entity)'}, {'cui': 'C0204700', 'cui_str': 'Fluid restriction (procedure)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441840', 'cui_str': 'Group F (qualifier value)'}, {'cui': 'C0441846', 'cui_str': 'Group L (qualifier value)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0150411', 'cui_str': 'Blood gases, arterial measurement (procedure)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0227514', 'cui_str': 'Portal triad structure'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0014479', 'cui_str': 'Ephedrine'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}]",140.0,0.133802,"RESULTS


Being in the fluid restriction Group (Group F) (odds ratio = 5.04) and cirrhosis (odds ratio = 3.28) were risk factors for hepatic surgical field bleeding.","[{'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, Beijing, 100142, China.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, Beijing, 100142, China.'}, {'ForeName': 'Huangmo', 'Initials': 'H', 'LastName': 'Jin', 'Affiliation': 'Department of Anesthesiology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, Beijing, 100142, China.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Tan', 'Affiliation': 'Department of Anesthesiology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, Beijing, 100142, China. maggitan@yeah.net.'}]",BMC surgery,['10.1186/s12893-020-0689-z']
3394,32044831,Efficacy and Safety of Carbon Dioxide Versus Air Insufflation for Colonoscopy in Deeply Sedated Pediatric Patients.,"OBJECTIVES


Studies have shown the advantages of carbon dioxide (CO2) over air insufflation in the adult population during colonoscopies. This study was designed to investigate the efficacy and safety of CO2 insufflation in deeply sedated children undergoing colonoscopy.
METHODS


This was a prospective, randomized, double-blind clinical trial. We recruited 100 consecutive pediatric patients who had colonoscopy under deep sedation for various indications. Patients were first randomized by history of abdominal pain and then randomly assigned to either CO2 or air insufflation. Postprocedural abdominal pain scores were registered on a 10-point visual analog rating scale and significant pain was defined as a score of 3 or higher. Abdominal circumferences and end tidal CO2 (ETCO2) levels were measured. Complications during and after the procedure were recorded.
RESULTS


We did not find statistically significant difference between CO2 and air insufflation on univariate analysis because of low number of children experiencing significant pain after colonoscopy. After adjusting for baseline pain, we found that pain was significantly lower in patients after CO2 versus air insufflation on multivariable analysis (P = 0.03). The significant factors related to pain were duration of the procedure (P = 0.006), history of abdominal pain (P = 0.002) and previous abdominal surgery (P = 0.02). CO2 insufflation was associated with decreased abdominal circumference after colonoscopy (P = 0.002). Girls were more likely to have pain regardless of intervention (P = .04).
CONCLUSIONS


Most children tolerate endoscopic procedures without significant pain. Our study was underpowered to show significant difference between air and CO2 on univariate analysis. CO2 insufflation during colonoscopy, however, may reduce postprocedural abdominal pain. Significant factors for increased pain on multivariate analysis included colonoscopy length over 30 minutes, history of abdominal pain, and previous abdominal surgery.",2020,We did not find statistically significant difference between CO2 and Air insufflation on univariate analysis due to low number of children experiencing significant pain after colonoscopy.,"['100 consecutive pediatric patients who had colonoscopy under deep sedation for various indications', 'adult population during colonoscopies', 'deeply sedated children undergoing colonoscopy', 'Deeply Sedated Pediatric Patients']","['Carbon Dioxide Versus Air Insufflation', 'CO2 insufflation', 'carbon dioxide (CO2', 'CO2 or air insufflation']","['Post-procedural abdominal pain scores', '10-point visual analog rating scale and significant pain', 'colonoscopy length over 30\u200amin, history of abdominal pain and previous abdominal surgery', 'efficacy and safety', 'history of abdominal pain', 'Efficacy and Safety', 'abdominal circumference', 'previous abdominal surgery', 'pain', 'CO2 insufflation', 'Abdominal circumferences and end tidal CO2 (ETCO2) levels']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C1956064', 'cui_str': 'Deep Sedation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4554317', 'cui_str': 'Deeply - dosing instruction fragment (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C1143776', 'cui_str': 'cobalt(II) bis(2,2,6,6-tetramethylheptane-3,5-dionate)'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference (observable entity)'}, {'cui': 'C1143776', 'cui_str': 'cobalt(II) bis(2,2,6,6-tetramethylheptane-3,5-dionate)'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C3267130', 'cui_str': 'End-tidal CO2'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",100.0,0.310231,We did not find statistically significant difference between CO2 and Air insufflation on univariate analysis due to low number of children experiencing significant pain after colonoscopy.,"[{'ForeName': 'Rajmohan', 'Initials': 'R', 'LastName': 'Dharmaraj', 'Affiliation': 'Division of Gastroenterology, University of New Mexico, Carrie Tingley Hospital, Albuquerque, NM.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Dunn', 'Affiliation': ""Division of Department of Gastroenterology, Peyton Manning Children's Hospital, Indianapolis, IN.""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Fritz', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Maine Medical Center, Portland, ME.'}, {'ForeName': 'Mahua', 'Initials': 'M', 'LastName': 'Dasgupta', 'Affiliation': 'Division of Quantitative Health Sciences, Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Pippa', 'Initials': 'P', 'LastName': 'Simpson', 'Affiliation': 'Division of Quantitative Health Sciences, Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Cabrera', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Miranda', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Diana G', 'Initials': 'DG', 'LastName': 'Lerner', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI.'}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002650']
3395,31842674,Joint sparing Kirschner-wire fixation for displaced proximal phalangeal neck fractures: randomized prospective comparative study.,"The aim of this study was to compare two joint sparing Kirschner-wire fixation techniques for displaced proximal phalangeal neck fractures. Forty-six patients with proximal phalangeal neck fractures managed by either percutaneous antegrade flexible intramedullary nailing (Group I) or crossed Kirschner-wires (Group II) were recruited for a randomized prospective comparative study. Clinical and radiological assessment of all patients was done in addition to the Kang scoring system, Disability of Arm, Shoulder and Hand score and total active motion. The mean time for radiological union for both groups was 5.8 weeks. The mean postoperative total active motion, Kang and the Disability of Arm, Shoulder and Hand scores were better in Group I patients, but without any statistically significant differences. Closed reduction and percutaneous Kirschner-wire fixation by a joint sparing approach will yield good functional results with no or minimal complications in proximal phalangeal neck fractures.  Level of evidence:  II.",2020,"The mean postoperative total active motion and the Disability of Arm, Shoulder and Hand Kang scores the mean postoperative total active motion, Kang and the Disability of Arm, Shoulder and Hand scores were better in Group I patients, but without any statistically significant differences.","['Forty-six patients with proximal phalangeal neck fractures managed by either', 'displaced proximal phalangeal neck fractures', 'proximal phalangeal neck fractures']","['percutaneous antegrade flexible intramedullary nailing (Group I) or crossed Kirschner-wires', 'percutaneous Kirschner-wire fixation by a joint sparing approach', 'joint sparing Kirschner-wire fixation techniques', 'Joint sparing Kirschner-wire fixation']","['mean time for radiological union', 'mean postoperative total active motion and the Disability of Arm, Shoulder and Hand Kang scores the mean postoperative total active motion, Kang and the Disability of Arm, Shoulder and Hand scores', 'Kang scoring system, Disability of Arm, Shoulder and Hand score and total active motion']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0677513', 'cui_str': 'Antegrade (qualifier value)'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0021885', 'cui_str': 'Intramedullary Nailing'}, {'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0086510', 'cui_str': 'Kirschner Wires'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0231481', 'cui_str': 'Active movement (observable entity)'}, {'cui': 'C1997924', 'cui_str': 'Disability of arm'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]",46.0,0.021017,"The mean postoperative total active motion and the Disability of Arm, Shoulder and Hand Kang scores the mean postoperative total active motion, Kang and the Disability of Arm, Shoulder and Hand scores were better in Group I patients, but without any statistically significant differences.","[{'ForeName': 'Ahmed Fathy', 'Initials': 'AF', 'LastName': 'Sadek', 'Affiliation': 'Orthopaedic Surgery Department, Minia University Hospital, Minia, Egypt.'}]","The Journal of hand surgery, European volume",['10.1177/1753193419894143']
3396,32023397,Synbiotics use for preventing sepsis and necrotizing enterocolitis in very low birth weight neonates: a randomized controlled trial.,"BACKGROUND


Probiotics and prebiotics have strain-specific effects on the host. Synbiotics, a mixture of probiotics and prebiotics, are proposed to have more beneficial effects on the host than either agent has alone.
PURPOSE


We performed a randomized controlled trial to investigate the effect of Lactobacillus and Bifidobacterium together with oligosaccharides and lactoferrin on the development of necrotizing enterocolitis (NEC) or sepsis in very low birth weight neonates.
METHODS


Neonates with a gestational age ≤32 weeks and birth weight ≤1,500 g were enrolled. The study group received a combination of synbiotics and lactoferrin, whereas the control group received 1 mL of distilled water as placebo starting with the first feed until discharge. The outcome measures were the incidence of NEC stage ≥2 or late-onset cultureproven sepsis and NEC stage ≥2 or death.
RESULTS


Mean birth weight and gestational age of the study (n=104) and the control (n=104) groups were 1,197±235 g vs. 1,151±269 g and 29±1.9 vs. 28±2.2 weeks, respectively (P>0.05). Neither the incidence of NEC stage ≥2 or death, nor the incidence of NEC stage ≥2 or late-onset culture-proven sepsis differed between the study and control groups (5.8% vs. 5.9%, P=1; 26% vs. 21.2%, P=0.51). The only significant difference was the incidence of all stages of NEC (1.9% vs. 10.6%, P=0.019).
CONCLUSION


The combination of synbiotics and lactoferrin did not reduce NEC severity, sepsis, or mortality.",2020,"Neither the incidence of stage ≥2 NEC or death nor the incidence of stage ≥2 NEC or late onset culture proven sepsis differed between the study and the control group (5.8% vs 5.9%, p = 1; 26% vs 21.2%, p=0.51).","['Methods\n\n\nNeonates with a gestational age of ≤32 weeks and birth weight of ≤1500 g were enrolled', 'very low birth weight neonates', 'Results\n\n\nBirth weight and gestational age of the study (n=104) and the control (n=104']","['ml distilled water as placebo', 'Lactobacillus and Bifidobacterium together with oligosaccharides and lactoferrin', 'Synbiotic', 'combination of synbiotic and lactoferrin', 'synbiotic and lactoferrin']","['incidence of stage ≥2 NEC or death nor the incidence of stage ≥2 NEC or late onset culture proven sepsis', 'severity of NEC, sepsis or mortality', 'incidence of all stages of NEC', 'necrotizing enterocolitis (NEC) or sepsis', 'incidence of stage ≥2 NEC or late onset culture proven sepsis and stage ≥2 NEC or death', 'sepsis and necrotizing enterocolitis']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharides'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0912341', 'cui_str': ""N'(OB)EC""}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0520459', 'cui_str': 'Necrotizing Enterocolitis'}]",,0.231798,"Neither the incidence of stage ≥2 NEC or death nor the incidence of stage ≥2 NEC or late onset culture proven sepsis differed between the study and the control group (5.8% vs 5.9%, p = 1; 26% vs 21.2%, p=0.51).","[{'ForeName': 'Ozge', 'Initials': 'O', 'LastName': 'Serce Pehlevan', 'Affiliation': ""Neonatology Unit, Zeynep Kamil Maternity and Children's Training and Research Hospital, University of Health Sciences, Istanbul, Turkey.""}, {'ForeName': 'Derya', 'Initials': 'D', 'LastName': 'Benzer', 'Affiliation': ""Neonatology Unit, Zeynep Kamil Maternity and Children's Training and Research Hospital, University of Health Sciences, Istanbul, Turkey.""}, {'ForeName': 'Tugba', 'Initials': 'T', 'LastName': 'Gursoy', 'Affiliation': 'Neonatology Unit, Koc University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Guner', 'Initials': 'G', 'LastName': 'Karatekin', 'Affiliation': ""Neonatology Unit, Zeynep Kamil Maternity and Children's Training and Research Hospital, University of Health Sciences, Istanbul, Turkey.""}, {'ForeName': 'Fahri', 'Initials': 'F', 'LastName': 'Ovali', 'Affiliation': ""Neonatology Unit, Zeynep Kamil Maternity and Children's Training and Research Hospital, University of Health Sciences, Istanbul, Turkey.""}]",Clinical and experimental pediatrics,['10.3345/cep.2019.00381']
3397,31977840,Prediction of Smoking Abstinence in Women Living With Human Immunodeficiency Virus Infection.,"BACKGROUND


This study examined whether baseline negative emotional states (depression and anxiety) would predict craving for cigarettes and other nicotine withdrawal symptoms in early abstinence and whether those emotional states and withdrawal symptoms would predict failure in quitting smoking at 3 months postquit among U.S. women living with the human immunodeficiency virus (HIV).
METHOD


The study is a secondary analysis of data from two smoking cessation studies of women living with HIV. Craving for cigarettes and other withdrawal symptoms were assessed weekly with a total of 229 observations during the first 4 weeks following quit day. Descriptive statistics were used to examine baseline characteristics of the participants. A random growth curve model was used to estimate between-person differences in a within-person trend of changes in the withdrawal symptoms. A binary logistic regression analysis was performed to identify predictors of short-term smoking abstinence.
RESULTS


Baseline anxiety was a predictor of postquit nicotine withdrawal symptoms but baseline depression was not. Neither baseline anxiety nor depression predicted postquit craving for cigarettes. Participants who received an HIV-tailored smoking cessation intervention showed a greater decline in craving symptom than those who received an attention-controlled intervention. HIV-tailored intervention and less craving predicted smoking abstinence at 3-month follow-up.
DISCUSSION


Compared to an attention-controlled intervention, an HIV-tailored intervention effectively decreased craving for cigarette smoking after quitting-which effectively increased the rate of short-term smoking abstinence in women living with HIV.",2020,"Compared to an attention-controlled intervention, an HIV-tailored intervention effectively decreased craving for cigarette smoking after quitting-which effectively increased the rate of short-term smoking abstinence in women living with HIV.","['women living with HIV', 'Women Living with Human Immunodeficiency Virus Infection']","['HIV-tailored smoking cessation intervention', 'HIV-tailored intervention']","['craving symptom', 'rate of short-term smoking abstinence', 'Craving for cigarettes and other withdrawal symptoms', 'Smoking Abstinence']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal Symptoms'}]",229.0,0.125838,"Compared to an attention-controlled intervention, an HIV-tailored intervention effectively decreased craving for cigarette smoking after quitting-which effectively increased the rate of short-term smoking abstinence in women living with HIV.","[{'ForeName': 'Sun S', 'Initials': 'SS', 'LastName': 'Kim', 'Affiliation': 'Sun S. Kim, PhD, RN, is Associate Professor, College of Nursing and Health Science, University of Massachusetts Boston. Mary E. Cooley, PhD, RN, FAAN, is Nurse Scientist, Phyllis F. Cantor Center, Dana-Farber Cancer Institute, Boston, Massachusetts. Sang A Lee, MS, RN, is Doctoral Student, College of Nursing and Health Science, University of Massachusetts Boston. Rosanna F. DeMarco, PhD, RN, FAAN, is Professor and Associate Dean for Academic Affairs, College of Nursing and Health Science, University of Massachusetts Boston.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Cooley', 'Affiliation': ''}, {'ForeName': 'Sang A', 'Initials': 'SA', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Rosanna F', 'Initials': 'RF', 'LastName': 'DeMarco', 'Affiliation': ''}]",Nursing research,['10.1097/NNR.0000000000000421']
3398,32037209,Effects of cold chemical (glutaraldehyde) versus autoclaving sterilization on the rate of coating loss of aesthetic archwires: A double-blind randomized clinical trial.,"OBJECTIVE


The effect of any sterilization methods (cold chemical, or hot) on film removal from coated archwires has not yet been investigated. Thus, we assessed it.
MATERIALS AND METHODS


This double-blind randomized clinical trial was performed on 120 observations: 40 macroscopically intact coated archwires from 4 brands were purchased (n=10 archwires/brand). Five wires from each brand underwent cold and 5 underwent hot sterilization. Wires were applied in 40 non-extractions patients at alignment phase of treatment (one month). Afterwards, 3 inter-bracket segments from each wire were examined microscopically, and the percentage of coating loss was recorded for each segment. Coating losses of the 4 brands and 2 sterilization methods were compared using a two-way ANOVA and a Welch t-test (α=0.05). Surfaces were also evaluated using scanning electron microscopy.
RESULTS


The mean surface coating loss of hot (autoclave) and cold (glutaraldehyde) sterilization methods was 25.6±28.7 and 28.1±30.8 percent respectively. The mean surface coating removal of the Ortho Organizers, American Orthodontics, SIA, and Gestenco brands were 24.1±28.4, 36.7±36.0, 23.0±24.4, and 23.6±28.0 percent, respectively. The two-way ANOVA indicated a lack of overall significant differences among wire brands (P=0.189) and between sterilization types (P=0.629). However, the interaction of sterilization and brands was significant (P=0.005).
CONCLUSIONS


Within the limitations of this 1-month clinical trial limited to 4 coated NiTi archwire brands only, the average coating removal of examined brands might not differ much, amounting to about 26% within a month. Glutaraldehyde and autoclave sterilization might not affect the average speed of coating loss in all brands, although each sterilization method might be favourable for certain brands.",2020,The mean surface coating loss of hot (autoclave) and cold (glutaraldehyde) sterilization methods was 25.6±28.7 and 28.1±30.8 percent respectively.,['120 observations: 40 macroscopically intact coated archwires from 4 brands were purchased (n=10 archwires/brand'],"['sterilization methods (cold chemical, or hot', 'Glutaraldehyde and autoclave sterilization', 'cold chemical (glutaraldehyde) versus autoclaving sterilization']","['average speed of coating loss', 'mean surface coating loss of hot (autoclave) and cold (glutaraldehyde) sterilization methods', 'percentage of coating loss', 'rate of coating loss of aesthetic archwires', 'mean surface coating removal', 'Coating losses']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}]","[{'cui': 'C0362065', 'cui_str': 'Sterilization'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0220806', 'cui_str': 'Chemical (substance)'}, {'cui': 'C0444519', 'cui_str': 'Hot sensation quality (qualifier value)'}, {'cui': 'C0017814', 'cui_str': 'Glutaral'}, {'cui': 'C0179177', 'cui_str': 'Autoclave, device (physical object)'}]","[{'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0444519', 'cui_str': 'Hot sensation quality (qualifier value)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0362065', 'cui_str': 'Sterilization'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}]",120.0,0.127952,The mean surface coating loss of hot (autoclave) and cold (glutaraldehyde) sterilization methods was 25.6±28.7 and 28.1±30.8 percent respectively.,"[{'ForeName': 'Seyed Mohammad', 'Initials': 'SM', 'LastName': 'Mousavi', 'Affiliation': 'Ahvaz Jundishapur University of Medical Sciences, Department of Orthodontics, Ahvaz, Iran.'}, {'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Shamohammadi', 'Affiliation': 'Ahvaz Jundishapur University of Medical Sciences, Department of Orthodontics, Ahvaz, Iran. Electronic address: milad.shamohammadi@yahoo.com.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Moradi', 'Affiliation': 'North Khorasan University of Medical Sciences, School of Dentistry, Department of Orthodontics, Bojnurd, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Hormozi', 'Affiliation': 'Isfahan University of Medical Sciences, School of Dentistry, Dental Research Center, Department of Orthodontics, Isfahan, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Rakhshan', 'Affiliation': 'Azad University, Department of Dental Anatomy, Faculty of Dentistry, Tehran, Iran.'}]",International orthodontics,['10.1016/j.ortho.2019.12.003']
3399,31599955,Adiposity and Fat-Free Mass of Children Born with Very Low Birth Weight Do Not Differ in Children Fed Supplemental Donor Milk Compared with Those Fed Preterm Formula.,"BACKGROUND


Many mothers of very-low-birth-weight (VLBW) infants (<1500 g) are unable to provide sufficient breast milk, and supplemental pasteurized donor human milk (donor milk) or preterm formula is required. The composition of donor milk differs from that of mother's milk and infants fed with donor milk often exhibit slower growth during hospitalization. The long-term impact of nutrient-enriched donor milk on growth, body composition, or blood pressure is unknown.
OBJECTIVE


We aimed to determine the effects of nutrient-enriched donor milk compared with preterm formula on growth, body composition, and blood pressure of children born preterm and with VLBW. Associations with in-hospital mother's milk intake were explored.
METHODS


This study was a follow-up of children at 5.5-y of age who participated in a randomized controlled trial evaluating the effect of nutrient-enriched donor milk (commencing at ≥120 mL·kg-1·d-1) or preterm formula fed as a supplement when mother's milk was unavailable. The trial intervention lasted 90 d or until hospital discharge, whichever occurred first. In this follow-up investigation, differences in total body fat percentage determined by using air displacement plethysmography (primary outcome), fat-free mass, skinfold thickness, waist circumference, BMI z scores, and blood pressure] were evaluated using linear regressions.
RESULTS


Of 316 surviving infants from the earlier trial, 158 (50%) participated in the current study (53% male). Mean ± SD birth weight and gestational age were 1013 ± 264 g and 27.9 ± 2.5 wk. The median (IQR) intervention period was 67.5 d (52.0-91.0 d). Mean ± SD age and BMI z score at follow-up were 5.7 ± 0.2 y and -0.3 ± 1.2. Supplemental nutrient-enriched donor milk, compared to preterm formula, was not associated with growth, body composition, or blood pressure. In-hospital mother's milk intake was positively associated with height z score at 5.5 y (β: 0.07; 95% CI: 0.004, 0.1; P = 0.04).
CONCLUSIONS


Supplemental nutrient-enriched donor milk and preterm formula during initial hospitalization results in comparable long-term growth and body composition in young children born VLBW. This trial was registered at clinicaltrials.gov as NCT02759809 and at isrctn.com as ISRCTN35317141.",2020,"Supplemental nutrient-enriched donor milk, compared to preterm formula, was not associated with growth, body composition, or blood pressure.","['Many mothers of very-low-birth-weight (VLBW) infants (<1500 g', 'SD birth weight and gestational age were 1013\xa0±', 'children at 5.5-y of age who participated', 'children born preterm and with VLBW', 'Children Born with Very Low Birth Weight', 'Children Fed Supplemental Donor Milk', 'young children born VLBW', '316 surviving infants from the earlier trial, 158 (50%) participated in the current study (53% male']","['Supplemental nutrient-enriched donor milk', 'nutrient-enriched donor milk compared with preterm formula', 'nutrient-enriched donor milk (commencing at ≥120 mL·kg-1·d-1) or preterm formula fed', 'Supplemental nutrient-enriched donor milk and preterm formula', 'nutrient-enriched donor milk']","['total body fat percentage determined by using air displacement plethysmography (primary outcome), fat-free mass, skinfold thickness, waist circumference, BMI z scores, and blood pressure', 'Adiposity and Fat-Free Mass', 'Mean\xa0±\xa0SD age and BMI z score', 'Mean\xa0±', 'height z score', 'growth, body composition, and blood pressure', 'growth, body composition, or blood pressure']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0282667', 'cui_str': 'Infant, Very Low Birth Weight'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0026131', 'cui_str': 'Milk'}]","[{'cui': 'C0424677', 'cui_str': 'Total body fat (observable entity)'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0032221', 'cui_str': 'Plethysmography'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0037302', 'cui_str': 'Skinfold Thickness'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}]",,0.143212,"Supplemental nutrient-enriched donor milk, compared to preterm formula, was not associated with growth, body composition, or blood pressure.","[{'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'McGee', 'Affiliation': 'Department of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Unger', 'Affiliation': 'Department of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Hamilton', 'Affiliation': 'Department of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Catherine S', 'Initials': 'CS', 'LastName': 'Birken', 'Affiliation': 'Department of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Zdenka', 'Initials': 'Z', 'LastName': 'Pausova', 'Affiliation': 'Department of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kiss', 'Affiliation': 'Institute for Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Bando', 'Affiliation': 'Translational Medicine Program, The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}]",The Journal of nutrition,['10.1093/jn/nxz234']
3400,32015461,"Double blind, two dose, randomized, placebo-controlled, cross-over clinical trial of the positive allosteric modulator at the alpha7 nicotinic cholinergic receptor AVL-3288 in schizophrenia patients.","Despite their theoretical rationale, nicotinic alpha-7 acetylcholine (nα 7 ) receptor agonists, have largely failed to demonstrate efficacy in placebo-controlled trials in schizophrenia. AVL-3288 is a nα 7  positive allosteric modulator (PAM), which is only active in the presence of the endogenous ligand (acetylcholine), and thus theoretically less likely to cause receptor desensitization. We evaluated the efficacy of AVL-3288 in a Phase 1b, randomized, double-blind, placebo-controlled, triple cross-over study. Twenty-four non-smoking, medicated, outpatients with schizophrenia or schizoaffective disorder and a Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) ≥62 were randomized. Each subject received 5 days of AVL-3288 (10, 30 mg) and placebo across three separate treatment weeks. The primary outcome measure was the RBANS total scale score, with auditory P50 evoked potential suppression the key target engagement biomarker. Secondary outcome measures include task-based fMRI (RISE task), mismatch negativity, the Scale for the Assessment of Negative Symptoms of Schizophrenia (SANS) and the Brief Psychiatric Rating Scale (BPRS). Twenty-four subjects were randomized and treated without any clinically significant treatment emergent adverse effects. Baseline RBANS (82 ± 17) and BPRS (41 ± 13) scores were consistent with moderate impairment. Primary outcomes were negative, with non-significant worsening for both active groups vs. placebo in the P50 and minimal between group changes on the RBANS. In conclusion, the results did not indicate efficacy of the compound, consistent with most prior results for the nα 7  target.",2020,"Primary outcomes were negative, with non-significant worsening for both active groups vs. placebo in the P50 and minimal between group changes on the RBANS.","['schizophrenia patients', 'Twenty-four non-smoking, medicated, outpatients with schizophrenia or schizoaffective disorder and a repeatable battery for the assessment of neuropsychological status (RBANS) ≥62 were randomized']","['placebo', 'AVL-3288']","['task-based fMRI (RISE task), mismatch negativity, the scale for the assessment of negative symptoms of schizophrenia (SANS) and the brief psychiatric rating scale (BPRS', 'RBANS total scale score, with auditory P50 evoked potential suppression the key target engagement biomarker']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective Disorder'}, {'cui': 'C4505412', 'cui_str': 'Repeatable Battery for the Assessment of Neuropsychological Status'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0449216', 'cui_str': 'aVL (body structure)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0222045'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0029941', 'cui_str': 'Overall and Gorham Brief Psychiatric Rating Scale'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C3850132', 'cui_str': 'P50 Wave'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",24.0,0.429793,"Primary outcomes were negative, with non-significant worsening for both active groups vs. placebo in the P50 and minimal between group changes on the RBANS.","[{'ForeName': 'Joshua T', 'Initials': 'JT', 'LastName': 'Kantrowitz', 'Affiliation': 'Columbia University, New York, USA. jk3380@cumc.columbia.edu.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Javitt', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Freedman', 'Affiliation': 'U Colorado, Denver, CO, USA.'}, {'ForeName': 'Pejman', 'Initials': 'P', 'LastName': 'Sehatpour', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Lawrence S', 'Initials': 'LS', 'LastName': 'Kegeles', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Carlson', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Sobeih', 'Affiliation': 'Nathan Kline Institute, Orangeburg, USA.'}, {'ForeName': 'Melanie M', 'Initials': 'MM', 'LastName': 'Wall', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Tse-Hwei', 'Initials': 'TH', 'LastName': 'Choo', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Blair', 'Initials': 'B', 'LastName': 'Vail', 'Affiliation': 'New York State Psychiatric Institute, New York, USA.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Grinband', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Lieberman', 'Affiliation': 'Columbia University, New York, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0628-9']
3401,31605616,The Effect of Maternal Multiple Micronutrient Supplementation on Female Early Infant Mortality Is Fully Mediated by Increased Gestation Duration and Intrauterine Growth.,"BACKGROUND


Maternal micronutrient supplementation in pregnancy (MMS) has been shown to improve birth weight among infants in low- and middle-income countries. Recent evidence suggests that the survival benefits of MMS are greater for female infants compared to male infants, but the mechanisms leading to differential effects remain unclear.
OBJECTIVE


The objective of this study was to examine the potential mechanisms through which MMS acts on infant mortality among Tanzanian infants.
METHODS


We used data collected from pregnant women and newborns in a randomized, double-blind, placebo-controlled trial of MMS conducted in Tanzania to examine mediators of the effect of MMS on 6-wk infant mortality (NCT00197548). Causal mediation analyses with the counterfactual approach were conducted to assess the contributions of MMS on survival via their effects on birth weight, gestational age, weight-for-gestational age, and the joint effect of gestational age and weight-for-gestational age. The weighting method allowed for interaction between gestational age and weight-for-gestational age.
RESULTS


Among 7486 newborns, the effect of MMS on 6-wk survival was fully mediated (100%) through the joint effect of gestational age and weight-for-gestational age. MMS was also found to have a significant natural indirect effect through increased birth weight (P-value < 0.001) that explained 75% of the total effect on 6-wk mortality. When analyses were stratified by sex, changes in gestational age and weight-for-gestational age fully mediated the mortality effect among female infants (n = 3570), but these mediators only explained 34% of the effect among males (n = 3833).
CONCLUSIONS


The potential sex-specific effects of MMS on mortality may be a result of differences in mechanisms related to birth outcomes. In the context of the Tanzanian trial, the observed effect of MMS on 6-wk mortality for female infants was entirely mediated by increased gestation duration and improved intrauterine growth, while these mechanisms did not appear to be major contributors among male infants.",2020,"When analyses were stratified by sex, changes in gestational age and weight-for-gestational age fully mediated the mortality effect among female infants (n = 3570), but these mediators only explained 34% of the effect among males (n = 3833).
","['female infants', 'male infants', 'pregnant women and newborns', 'Tanzanian infants', '7486 newborns']","['placebo', 'MMS', 'Maternal Multiple Micronutrient Supplementation', 'Maternal micronutrient supplementation']","['6-wk survival', 'Female Early Infant Mortality', 'birth weight', 'gestation duration and improved intrauterine growth', 'survival benefits of MMS']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0021278', 'cui_str': 'Infant Mortality'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]",,0.27157,"When analyses were stratified by sex, changes in gestational age and weight-for-gestational age fully mediated the mortality effect among female infants (n = 3570), but these mediators only explained 34% of the effect among males (n = 3833).
","[{'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Quinn', 'Affiliation': 'Department of Global Health and Population, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Smith', 'Affiliation': 'Department of Global Health and Population, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Paige L', 'Initials': 'PL', 'LastName': 'Williams', 'Affiliation': 'Department of Biostatistics, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Willy', 'Initials': 'W', 'LastName': 'Urassa', 'Affiliation': 'Department of Microbiology and Immunology, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Epidemiology, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Gernard', 'Initials': 'G', 'LastName': 'Msamanga', 'Affiliation': 'Department of Community Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Wafaie W', 'Initials': 'WW', 'LastName': 'Fawzi', 'Affiliation': 'Department of Global Health and Population, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Sudfeld', 'Affiliation': 'Department of Global Health and Population, Harvard TH Chan School of Public Health, Boston, MA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxz246']
3402,31938818,Effect of vitamin D on bone strength in older African Americans: a randomized controlled trial.,"There is controversy over whether African Americans have higher vitamin D requirements than recommended by the Institute of Medicine. We previously reported that maintaining serum 25(OH)D above 30 ng/mL does not prevent age-related bone loss. Herein, we report that bone strength is also unaffected by maintaining this level in this population.
INTRODUCTION


The role of vitamin D in bone strength has not been investigated in the African American (AA) population.
METHODS


A 3-year randomized controlled trial was designed to examine the effect of vitamin D supplementation on physical performance, bone loss, and bone strength in healthy older AA women. A total of 260 postmenopausal AA women, ages ≥ 60 years were randomized to a vitamin D 3  or placebo arm. Vitamin D 3  dose was adjusted to maintain serum 25OHD > 30 ng/mL. Bone mineral density, femoral axis length, and femoral neck (FN) width were measured by dual-energy X-ray absorptiometry. Composite indices of FN strength [compression strength index (CSI), bending strength index (BSI), and impact strength index (ISI)] were computed.
RESULTS


The mean age of participants was 68.2 ± 4.9 years. Baseline characteristics between groups were similar. The average dose of vitamin D 3  was 3490 ± 1465 IU/day in the active group. The mean serum 25OHD was 46.8 ± 1.2 ng/mL versus 20.7 ± 1.1 ng/mL in the active versus placebo group. Serum 25OHD did not correlate with any composite indices. The longitudinal differences observed in FN width, CSI, BSI, and ISI in both groups were not statistically significant (all p values > 0.05). Further, there was no group × time interaction effect for any of the composite indices (all p values > 0.05).
CONCLUSION


Maintaining serum 25OHD > 30 ng/mL (75 nmol/L) does not affect bone strength in older AA women. There is no evidence to support vitamin D intake greater than the recommended RDA by the Institute of Medicine in this population for bone strength.",2020,"The longitudinal differences observed in FN width, CSI, BSI, and ISI in both groups were not statistically significant (all p values > 0.05).","['African American (AA) population', '60\xa0years', 'healthy older AA women', 'The mean age of participants was 68.2\u2009±\u20094.9\xa0years', '30', 'African Americans', 'older African Americans', 'older AA women', '260 postmenopausal AA women, ages ≥']","['vitamin D supplementation', 'vitamin D', 'vitamin D 3  or placebo', 'placebo']","['bone strength', 'Bone mineral density, femoral axis length, and femoral neck ', 'FN strength [compression strength index (CSI), bending strength index (BSI), and impact strength index (ISI', 'FN width, CSI, BSI, and ISI', 'vitamin D requirements', 'physical performance, bone loss, and bone strength', 'Serum 25OHD', 'serum 25OHD', 'mean serum 25OHD']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4704755', 'cui_str': 'Flexural Properties'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C2607857'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",260.0,0.342175,"The longitudinal differences observed in FN width, CSI, BSI, and ISI in both groups were not statistically significant (all p values > 0.05).","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Dhaliwal', 'Affiliation': 'Metabolic Bone Disease Center, State University of New York Upstate Medical University, 750 East Adams Street, Syracuse, NY, 13210, USA. dhaliwar@upstate.edu.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Islam', 'Affiliation': 'Bone Mineral Research Center, NYU-Long Island School of Medicine, Mineola, NY, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mikhail', 'Affiliation': 'Bone Mineral Research Center, NYU-Long Island School of Medicine, Mineola, NY, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ragolia', 'Affiliation': 'Bone Mineral Research Center, NYU-Long Island School of Medicine, Mineola, NY, USA.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Aloia', 'Affiliation': 'Bone Mineral Research Center, NYU-Long Island School of Medicine, Mineola, NY, USA.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-019-05275-1']
3403,25735317,Effectiveness of bevacizumab added to standard chemotherapy in metastatic colorectal cancer: final results for first-line treatment from the ITACa randomized clinical trial.,"BACKGROUND


We report the results from a first-line phase III randomized clinical trial on metastatic colorectal cancer (mCRC) aimed at evaluating the effectiveness of adding bevacizumab (B) to standard first-line chemotherapy (CT).
PATIENTS AND METHODS


mCRC patients were randomized to receive first-line CT (FOLFIRI or FOLFOX4) plus B (arm A) or CT only (arm B). The primary end point was progression-free survival (PFS). Secondary end points included overall survival (OS), response rate (ORR) and safety. Three hundred and fifty patients and 310 events were required to have an 80% statistical power to detect a difference in PFS between the groups.
RESULTS


Between November 2007 and March 2012, 376 patients were randomized. About 60% of patients received FOLFOX4 and 40% FOLFIRI. After a median follow-up of 36 months, 343 progressions and 275 deaths had been observed in the overall population. The median PFS was 9.6 [95% confidence interval (CI) 8.2-10.3] and 8.4 (95% CI 7.2-9.0) months for arms A and B, respectively, with a hazard ratio of 0.86 (95% CI 0.70-1.07; P = 0.182). No statistically significant differences in OS or ORR were observed. B-containing regimens were associated with more frequent hypertension, bleeding, proteinuria and asthenia.
CONCLUSIONS


The addition of B to standard first-line CT for mCRC did not provide a benefit in terms of PFS, OS or ORR. Further research is warranted to better identify the target population.
CLINICAL TRIAL NUMBER


NCT01878422.",2015,"The addition of B to standard first-line CT for mCRC did not provide a benefit in terms of PFS, OS or ORR.","['mCRC patients', 'metastatic colorectal cancer (mCRC', 'Between November 2007 and March 2012, 376 patients were randomized', 'metastatic colorectal cancer']","['standard chemotherapy', 'bevacizumab', 'first-line CT (FOLFIRI or FOLFOX4) plus B (arm A) or CT', 'bevacizumab (B) to standard first-line chemotherapy (CT']","['median PFS', 'OS or ORR', 'PFS', 'overall survival (OS), response rate (ORR) and safety', 'frequent hypertension, bleeding, proteinuria and asthenia', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",376.0,0.253185,"The addition of B to standard first-line CT for mCRC did not provide a benefit in terms of PFS, OS or ORR.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Passardi', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori. Electronic address: alessandro.passardi@irst.emr.it.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Nanni', 'Affiliation': 'Unit of Biostatistics and Clinical Trials, IRST IRCCS, Meldola.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Tassinari', 'Affiliation': 'Department of Oncology, Per gli Infermi Hospital, Rimini.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Turci', 'Affiliation': 'Oncology Unit, S. Maria delle Croci Hospital, Ravenna.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Cavanna', 'Affiliation': 'Medical Oncology Unit, Guglielmo da Saliceto Hospital, Piacenza.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Fontana', 'Affiliation': 'Oncology Unit, University Hospital of Modena and Reggio Emilia, Modena.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ruscelli', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mucciarini', 'Affiliation': 'Medical Oncology Unit, Ramazzini Hospital, Carpi.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Lorusso', 'Affiliation': 'Medical Oncology Unit, Vito Fazzi Hospital, Lecce; Department of Medical Oncology, Istituto Tumori, Bari, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ragazzini', 'Affiliation': 'Unit of Biostatistics and Clinical Trials, IRST IRCCS, Meldola.'}, {'ForeName': 'G L', 'Initials': 'GL', 'LastName': 'Frassineti', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Amadori', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdv130']
3404,31686628,"Letter to the Editor regarding 'Relationships between the use of pharmacomechanical catheter-directed thrombolysis, sonographic findings, and clinical outcomes in patients with acute proximal DVT: Results from the ATTRACT Multicenter Randomized Trial'.",,2020,,['patients with acute proximal DVT'],['pharmacomechanical catheter-directed thrombolysis'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}]","[{'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}]",[],,0.0887038,,"[{'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Gwozdz', 'Affiliation': ""Academic Department of Vascular Surgery, School of Cardiovascular Medicine and Science, Guy's and St Thomas' Hospital, King's College London, London, UK.""}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Baekgaard', 'Affiliation': 'Vascular Clinic, Gentofte Hospital and Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Silver', 'Affiliation': 'OhioHealth Heart & Vascular, Columbus, OH, USA.'}, {'ForeName': 'Nicos', 'Initials': 'N', 'LastName': 'Labropoulos', 'Affiliation': 'Department of Surgery, Stony Brook University, Stony Brook, NY, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Black', 'Affiliation': ""Academic Department of Vascular Surgery, School of Cardiovascular Medicine and Science, Guy's and St Thomas' Hospital, King's College London, London, UK.""}]","Vascular medicine (London, England)",['10.1177/1358863X19882753']
3405,25722382,Tecemotide in unresectable stage III non-small-cell lung cancer in the phase III START study: updated overall survival and biomarker analyses.,"BACKGROUND


Tecemotide is a MUC1-antigen-specific cancer immunotherapy. The phase III START study did not meet its primary end point but reported notable survival benefit with tecemotide versus placebo in an exploratory analysis of the predefined patient subgroup treated with concurrent chemoradiotherapy. Here, we attempted to gain further insight into the effects of tecemotide in START.
PATIENTS AND METHODS


START recruited patients who did not progress following frontline chemoradiotherapy for unresectable stage III non-small-cell lung cancer. We present updated overall survival (OS) data and exploratory analyses of OS for baseline biomarkers: soluble MUC1 (sMUC1), antinuclear antibodies (ANA), neutrophil/lymphocyte ratio (NLR), lymphocyte count, and HLA type.
RESULTS


Updated OS data are consistent with the primary analysis: median 25.8 months (tecemotide) versus 22.4 months (placebo) (HR 0.89, 95% CI 0.77-1.03, P = 0.111), with ∼20 months additional median follow-up time compared with the primary analysis. Exploratory analysis of the predefined subgroup treated with concurrent chemoradiotherapy revealed clinically relevant prolonged OS with tecemotide versus placebo (29.4 versus 20.8 months; HR 0.81, 95% CI 0.68-0.98, P = 0.026). No improvement was seen with sequential chemoradiotherapy. High sMUC1 and ANA correlated with a possible survival benefit with tecemotide (interaction P = 0.0085 and 0.0022) and might have future value as biomarkers. Interactions between lymphocyte count, NLR, or prespecified HLA alleles and treatment effect were not observed.
CONCLUSION


Updated OS data support potential treatment benefit with tecemotide in patients treated with concurrent chemoradiotherapy. Exploratory biomarker analyses suggest that elevated sMUC1 or ANA levels correlate with tecemotide benefit.
CLINICALTRIALSGOV NUMBER


NCT00409188.",2015,High sMUC1 and ANA correlated with a possible survival benefit with tecemotide (interaction P = 0.0085 and 0.0022) and might have future value as biomarkers.,"['START recruited patients who did not progress following frontline chemoradiotherapy for unresectable stage III non-small-cell lung cancer', 'patients treated with concurrent chemoradiotherapy']","['concurrent chemoradiotherapy', 'placebo']","['lymphocyte count, NLR, or prespecified HLA alleles and treatment effect', 'notable survival benefit', 'overall survival (OS) data and exploratory analyses of OS for baseline biomarkers: soluble MUC1 (sMUC1), antinuclear antibodies (ANA), neutrophil/lymphocyte ratio (NLR), lymphocyte count, and HLA type']","[{'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}]","[{'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0200635', 'cui_str': 'Lymphocyte Number'}, {'cui': 'C0002085', 'cui_str': 'Allelomorphs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0587178', 'cui_str': 'ANA measurement'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]",,0.388161,High sMUC1 and ANA correlated with a possible survival benefit with tecemotide (interaction P = 0.0085 and 0.0022) and might have future value as biomarkers.,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Mitchell', 'Affiliation': 'Olivia Newton-John Cancer and Wellness Centre, Austin Hospital, Melbourne, Australia. Electronic address: paul.mitchell@austin.org.au.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Thatcher', 'Affiliation': 'Christie Hospital NHS Trust, Manchester, UK.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Socinski', 'Affiliation': 'UPMC Cancer Pavilion, Pittsburgh, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Wasilewska-Tesluk', 'Affiliation': 'University of Warmia and Mazury, Olsztyn, Poland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Horwood', 'Affiliation': 'Princess Alexandra Hospital, Woolloongabba, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Szczesna', 'Affiliation': 'Mazowieckie Centrum Leczenia Chorób Pluc i Gruzlicy, Otwock, Poland.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Martín', 'Affiliation': 'Division of Clinical Oncology, Instituto Especializado Alexander Fleming, Buenos Aires, Argentina.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Ragulin', 'Affiliation': 'Medical Radiological Research Center, Obninsk, Russia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zukin', 'Affiliation': 'Clinical Oncology, Instituto Nacional do Câncer-INCA, Rio de Janeiro, Brazil.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Helwig', 'Affiliation': 'Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Falk', 'Affiliation': 'Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Butts', 'Affiliation': 'Cancer Care, Cross Cancer Institute, Edmonton.'}, {'ForeName': 'F A', 'Initials': 'FA', 'LastName': 'Shepherd', 'Affiliation': 'University Health Network, Princess Margaret Cancer Centre, Toronto, Canada.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdv104']
3406,32003836,Sodium-glucose cotransporter 2 inhibitors: extending the indication to non-diabetic kidney disease?,"This year the medical community was pleasantly surprised by the results of the first large outcome trial that primarily examined the renal effects of the sodium-glucose cotransporter 2 (SGLT2) inhibitor canagliflozin (CANA) in subjects with diabetes and impaired kidney function. The Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic Nephropathy (CREDENCE) trial showed that CANA, relative to placebo, reduces the risk for end-stage renal disease, doubling of creatinine or renal death by 34% [hazard ratio 0.66 (95% confidence interval 0.53-0.81]. These effects were consistent across baseline estimated glomerular filtration rate (eGFR) and haemoglobin A1c subgroups. In this review we combine the results of the CREDENCE trial with those of several cardiovascular outcome trials with SGLT2 inhibitors and show that, unexpectedly, patients with lower eGFR levels may have greater benefit with respect to cardiovascular outcome than patients with normal kidney function. The cardio- and renoprotective effects of SGLT2 inhibitors seem to be independent of their glucose-lowering effects, as shown in several post hoc analyses. In this review we discuss the alleged mechanisms of action that explain the beneficial effects of this novel class of drugs. Moreover, we discuss whether these findings indicate that this class of drugs may also be beneficial in non-diabetic chronic kidney diseases.",2020,These effects were consistent across baseline estimated glomerular filtration rate (eGFR) and haemoglobin A1c subgroups.,"['patients with normal kidney function', 'subjects with diabetes and impaired kidney function', 'Participants With Diabetic Nephropathy']","['sodium-glucose cotransporter 2 (SGLT2) inhibitor canagliflozin (CANA', 'Canagliflozin', 'SGLT2 inhibitors', 'placebo', 'Sodium-glucose cotransporter 2 inhibitors']","['glomerular filtration rate (eGFR) and haemoglobin A1c subgroups', 'Renal and Cardiovascular Outcomes', 'creatinine or renal death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0011881', 'cui_str': 'Diabetic Nephropathy'}]","[{'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C3273807', 'cui_str': 'Gliflozins'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.0444605,These effects were consistent across baseline estimated glomerular filtration rate (eGFR) and haemoglobin A1c subgroups.,"[{'ForeName': 'Claire C J', 'Initials': 'CCJ', 'LastName': 'Dekkers', 'Affiliation': 'Departments of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Ron T', 'Initials': 'RT', 'LastName': 'Gansevoort', 'Affiliation': 'Division of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfz264']
3407,25739671,Postoperative irinotecan in resected stage II-III rectal cancer: final analysis of the French R98 Intergroup trial†.,"BACKGROUD


The R98 trial explores the addition of irinotecan to a 5-fluorouracil (5-FU) plus leucovorin (5-FU/LV) adjuvant regimen in optimally resected stages II-III rectal cancers. We report the updated long-term results. Disease-free survival (DFS) was the primary end point.
PATIENST AND METHODS


Between March 1999 and December 2005, 357 patients were randomized: 178 in 5-FU/LV and 179 in LV5-FU2 + irinotecan arm. The trial was stratified by control arm: Mayo Clinic regimen or LV5-FU2 regimen.
RESULTS


Three hundred and fifty-seven randomized patients were evaluable for efficacy. With a follow-up of 156 months, the DFS was in favour of experimental arm but did not reach statistical significance [hazard ratio (HR) = 0.80, P = 0.154]. The same was observed for overall survival (OS) (HR = 0.87, P = 0.433). The 5-year DFS was 58% in the control arm and 63% in the experimental arm. The 5-year OS was 74% in the control arm and 75% in the experimental arm. Patients allocated to the experimental arm had more grade 3-4 neutropenia when compared with the LV5-FU2 arm (33% versus 6%, P = 0.03), but not when compared with the Mayo Clinic arm (33% versus 36%, P = 0.84). Grade 3-4 diarrhoea tended to be higher in the experimental arm, but analyses stratified by control arm or by radiotherapy failed to show significant differences across strata (test for interaction P = 0.44).
CONCLUSION


Even though a benefit of irinotecan in subgroups of patients cannot be excluded, due to early termination and lack of power, the study does not support the addition of irinotecan to 5-FU/LV in routine in patients with resected stage II-III rectal cancer.",2015,"With a follow-up of 156 months, the DFS was in favour of experimental arm but did not reach statistical significance [hazard ratio (HR) = 0.80, P = 0.154].","['357 patients were randomized: 178 in', 'resected stage II-III rectal cancer', 'optimally resected stages II-III rectal cancers', 'Between March 1999 and December 2005', 'patients with resected stage II-III rectal cancer']","['Postoperative irinotecan', '5-FU/LV and 179 in LV5-FU2 + irinotecan arm', '5-fluorouracil (5-FU) plus leucovorin (5-FU/LV) adjuvant regimen', '5-FU/LV', 'irinotecan', 'LV5-FU2']","['grade 3-4 neutropenia', 'overall survival (OS', '5-year OS', 'Grade 3-4 diarrhoea', '5-year DFS', 'Disease-free survival (DFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C4517609', 'cui_str': '179 (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",357.0,0.0941184,"With a follow-up of 156 months, the DFS was in favour of experimental arm but did not reach statistical significance [hazard ratio (HR) = 0.80, P = 0.154].","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Delbaldo', 'Affiliation': 'Oncology Unit, Diaconesses Croix Saint Simon Hospital, Paris. Electronic address: cdelbaldo@hopital-dcss.org.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ychou', 'Affiliation': ""Digestive Oncology Unit, ICM Val D'Aurelle, Montpellier.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zawadi', 'Affiliation': 'Radiotherapy Unit, Departemental Hospital Center, La Roche Sur Yon.'}, {'ForeName': 'J Y', 'Initials': 'JY', 'LastName': 'Douillard', 'Affiliation': 'Oncology Unit, René Gauducheau Center, St-Herblain.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'André', 'Affiliation': 'Oncology Unit, Saint-Antoine Hospital, GERCOR, and UMPC University Paris VI, Paris.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Guerin-Meyer', 'Affiliation': 'Oncology Unit, Paul Papin Center, Angers.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Rougier', 'Affiliation': 'Hepatogastroenterology and Digestive Oncology Unit, Université Paris V, Europeen Georges Pompidou Hospital, Paris.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Dupuis', 'Affiliation': 'Radiotherapy Unit, Jean-Bernard Center, Le Mans.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Faroux', 'Affiliation': 'Digestive Unit, Departemental Hospital Center, La Roche sur Yon.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Jouhaud', 'Affiliation': 'Radiotherapy Unit, Henri Mondor Hospital, Créteil, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Quinaux', 'Affiliation': 'International Development Drug Institute (IDDI), Louvain-la-Neuve, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Buyse', 'Affiliation': 'International Development Drug Institute (IDDI), Louvain-la-Neuve, Belgium.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Piedbois', 'Affiliation': 'Oncology Unit, Paul Strauss Center, Strasbourg, France.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdv135']
3408,25858497,"A randomized, placebo-controlled phase III trial of masitinib plus gemcitabine in the treatment of advanced pancreatic cancer.","BACKGROUND


Masitinib is a selective oral tyrosine-kinase inhibitor. The efficacy and safety of masitinib combined with gemcitabine was compared against single-agent gemcitabine in patients with advanced pancreatic ductal adenocarcinoma (PDAC).
PATIENTS AND METHODS


Patients with inoperable, chemotherapy-naïve, PDAC were randomized (1 : 1) to receive gemcitabine (1000 mg/m(2)) in combination with either masitinib (9 mg/kg/day) or a placebo. The primary endpoint was overall survival (OS) in the modified intent-to-treat population. Secondary OS analyses aimed to characterize subgroups with poor survival while receiving single-agent gemcitabine with subsequent evaluation of masitinib therapeutic benefit. These prospectively declared subgroups were based on pharmacogenomic data or a baseline characteristic.
RESULTS


Three hundred and fifty-three patients were randomly assigned to receive either masitinib plus gemcitabine (N = 175) or placebo plus gemcitabine (N = 178). Median OS was similar between treatment-arms for the overall population, at respectively, 7.7 and 7.1 months, with a hazard ratio (HR) of 0.89 (95% CI [0.70; 1.13]. Secondary analyses identified two subgroups having a significantly poor survival rate when receiving single-agent gemcitabine; one defined by an overexpression of acyl-CoA oxidase-1 (ACOX1) in blood, and another via a baseline pain intensity threshold (VAS > 20 mm). These subgroups represent a critical unmet medical need as evidenced from median OS of 5.5 months in patients receiving single-agent gemcitabine, and comprise an estimated 63% of patients. A significant treatment effect was observed in these subgroups for masitinib with median OS of 11.7 months in the 'ACOX1' subgroup [HR = 0.23 (0.10; 0.51), P = 0.001], and 8.0 months in the 'pain' subgroup [HR = 0.62 (0.43; 0.89), P = 0.012]. Despite an increased toxicity of the combination as compared with single-agent gemcitabine, side-effects remained manageable.
CONCLUSIONS


The present data warrant initiation of a confirmatory study that may support the use of masitinib plus gemcitabine for treatment of PDAC patients with overexpression of ACOX1 or baseline pain (VAS > 20mm). Masitinib's effect in these subgroups is also supported by biological plausibility and evidence of internal clinical validation.
TRIAL REGISTRATION


ClinicalTrials.gov:NCT00789633.",2015,"Median OS was similar between treatment-arms for the overall population, at respectively, 7.7 and 7.1 months, with a hazard ratio (HR) of 0.89 (95% CI [0.70; 1.13].","['PDAC patients with overexpression of ACOX1 or baseline pain (VAS > 20mm', 'Patients with inoperable, chemotherapy-naïve, PDAC', 'advanced pancreatic cancer', 'Three hundred and fifty-three patients', 'patients with advanced pancreatic ductal adenocarcinoma (PDAC']","['masitinib combined with gemcitabine', 'gemcitabine', 'placebo', 'gemcitabine (1000 mg/m(2)) in combination with either masitinib', 'placebo plus gemcitabine', 'masitinib plus gemcitabine']","['toxicity', 'efficacy and safety', 'survival rate', 'overall survival (OS', 'Median OS', 'overexpression of acyl-CoA oxidase-1 (ACOX1) in blood, and another via a baseline pain intensity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205187', 'cui_str': 'Inoperable (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}]","[{'cui': 'C2351398', 'cui_str': '4-((4-methylpiperazin-1-yl)methyl)-N-(4-methyl-3-((4-(pyridin-3-yl)-1,3-thiazol-2-yl)amino)phenyl)benzamide'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0050690', 'cui_str': 'Fatty Acyl-Coenzyme A Oxidase'}, {'cui': 'C0005768'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",353.0,0.137316,"Median OS was similar between treatment-arms for the overall population, at respectively, 7.7 and 7.1 months, with a hazard ratio (HR) of 0.89 (95% CI [0.70; 1.13].","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Deplanque', 'Affiliation': 'Department of Medical Oncology, Saint Joseph Hospital, Paris. Electronic address: gdeplanque@hpsj.fr.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Demarchi', 'Affiliation': 'Department of Medical Oncology, University Hospital of Besançon, Besançon.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hebbar', 'Affiliation': 'Department of Medical Oncology, University Hospital, Lille, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Flynn', 'Affiliation': 'Metro-Minnesota Community Clinical Oncology Program, Park Nicollet Institute, Minneapolis, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Melichar', 'Affiliation': 'Department of Oncology, Palacký University Medical School & Teaching Hospital, Olomouc, Czech Republic.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Atkins', 'Affiliation': 'Southeastern Medical Oncology Center, Goldsboro, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Nowara', 'Affiliation': 'Department of Clinical and Experimental Oncology, Maria Skłodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice, Poland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Moyé', 'Affiliation': 'Department of Biostatistics, University of Texas School of Public Health, Houston, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Piquemal', 'Affiliation': 'Clinical Development, Acobiom, Montpellier.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ritter', 'Affiliation': 'Clinical Development, Acobiom, Montpellier.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Dubreuil', 'Affiliation': 'Signaling, Hematopoiesis and Mechanism of Oncogenesis, Inserm U1068, CRCM, Marseille; Institut Paoli-Calmettes, Marseille; Aix-Marseille University, UM 105, Marseille; CNRS, UMR7258, CRCM, Marseille; Clinical Development, AB Science, Paris.'}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Mansfield', 'Affiliation': 'Clinical Development, AB Science, Paris.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Acin', 'Affiliation': 'Clinical Development, AB Science, Paris.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Moussy', 'Affiliation': 'Clinical Development, AB Science, Paris.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Hermine', 'Affiliation': 'Clinical Development, AB Science, Paris; Department of Clinical Hematology, Necker Hospital, Paris; INSERM UMR 1163, Laboratory of Cellular and Molecular Mechanisms of Hematological Disorders and Therapeutic Implications, Paris; Paris Descartes - Sorbonne Paris Cité University, Imagine Institute, Paris; CNRS ERL 8254, Paris; Laboratory of Excellence GR-Ex, Paris; National Reference Center on Mastocytosis (CEREMAST), Paris.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hammel', 'Affiliation': 'Department of Gastroenterology, Hôpital Beaujon, Clichy, France.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdv133']
3409,25862439,Dynamic prediction in breast cancer: proving feasibility in clinical practice using the TEAM trial.,"BACKGROUND


Predictive models are an integral part of current clinical practice and help determine optimal treatment strategies for individual patients. A drawback is that covariates are assumed to have constant effects on overall survival (OS), when in fact, these effects may change during follow-up (FU). Furthermore, breast cancer (BC) patients may experience events that alter their prognosis from that time onwards. We investigated the 'dynamic' effects of different covariates on OS and developed a nomogram to calculate 5-year dynamic OS (DOS) probability at different prediction timepoints (tP) during FU.
METHODS


Dutch and Belgian postmenopausal, endocrine-sensitive, early BC patients enrolled in the TEAM trial were included. We assessed time-varying effects of specific covariates and obtained 5-year DOS predictions using a proportional baselines landmark supermodel. Covariates included age, histological grade, hormone receptor and HER2 status, T- and N-stage, locoregional recurrence (LRR), distant recurrence, and treatment compliance. A nomogram was designed to calculate 5-year DOS based on individual characteristics.
RESULTS


A total of 2602 patients were included (mean FU 6.2 years). N-stage, LRR, and HER2 status demonstrated time-varying effects on 5-year DOS. Hazard ratio (HR) functions for LRR, high-risk N-stage (N2/3), and HER2 positivity were HR = (8.427 × 0.583[Formula: see text], HR = (3.621 × 0.816[Formula: see text], and HR = (1.235 × 0.851[Formula: see text], respectively. Treatment discontinuation was associated with a higher mortality risk, but without a time-varying effect [HR 1.263 (0.867-1.841)]. All other covariates were time-constant.
DISCUSSION


The current nomogram accounts for elapsed time since starting adjuvant endocrine treatment and optimizes prediction of individual 5-year DOS during FU for postmenopausal, endocrine-sensitive BC patients. The nomogram can facilitate in determining whether further therapy will benefit an individual patient, although validation in an independent dataset is still needed.",2015,"Treatment discontinuation was associated with a higher mortality risk, but without a time-varying effect [HR 1.263 (0.867-1.841)].","['individual patients', 'Dutch and Belgian postmenopausal, endocrine-sensitive, early BC patients enrolled in the TEAM trial were included', 'breast cancer', 'A total of 2602 patients were included (mean FU 6.2 years']",[],"['5-year dynamic OS (DOS) probability', 'overall survival (OS', 'histological grade, hormone receptor and HER2 status, T- and N-stage, locoregional recurrence (LRR), distant recurrence, and treatment compliance', '5-year DOS', 'Hazard ratio (HR) functions for LRR, high-risk N-stage (N2/3), and HER2 positivity', 'higher mortality risk']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0337797', 'cui_str': 'Belgians (ethnic group)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0456201', 'cui_str': 'Histological grades (qualifier value)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0456532', 'cui_str': 'N category'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C4319828', 'cui_str': 'Therapeutic Compliance'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",2602.0,0.0691017,"Treatment discontinuation was associated with a higher mortality risk, but without a time-varying effect [HR 1.263 (0.867-1.841)].","[{'ForeName': 'D B Y', 'Initials': 'DBY', 'LastName': 'Fontein', 'Affiliation': 'Department of Surgery.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Klinten Grand', 'Affiliation': 'Department of Medical Statistics.'}, {'ForeName': 'J W R', 'Initials': 'JWR', 'LastName': 'Nortier', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Leiden.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Seynaeve', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Meershoek-Klein Kranenbarg', 'Affiliation': 'Department of Surgery.'}, {'ForeName': 'L Y', 'Initials': 'LY', 'LastName': 'Dirix', 'Affiliation': 'Department of Medical Oncology, Academisch Ziekenhuis Sint-Augustinus Antwerp, Antwerp, Belgium.'}, {'ForeName': 'C J H', 'Initials': 'CJH', 'LastName': 'van de Velde', 'Affiliation': 'Department of Surgery.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Department of Medical Statistics. Electronic address: h.putter@lumc.nl.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdv146']
3410,31990328,Changes in physical activity of adolescent girls in the context of their perception of the Healthy Me programme.,"BACKGROUND


An assumption was made that results of programme evaluation lead to better understanding for whom this intervention may work. The aim of the article is to compare the changes in physical activity of the intervention programme participants depending on subjective assessment of its impact.
METHODS


The data were obtained from 14- to15-year-old Polish girls (N = 1120) from 48 random selected secondary schools participating in the 1-year Healthy Me programme in the 2017/2018. Schools were randomly assigned to one of two types of intervention or to a control (null) group. Satisfaction with the programme according to 21 criteria was measured retrospectively just after the intervention. Change in MVPA (moderate-to-vigorous physical activity) during the programme implementation was assessed in relation to satisfaction level, and adjusted for initial MVPA.
RESULTS


In total, the MVPA did not change significantly comparing pre- and post-intervention surveys (3.94 ± 1.94 vs. 3.87 ± 1.93)-P = 0.093. However, the perceived notable improvement of functioning in 10 out of 21 areas was related to the unquestionable increase in MVPA (P ≤ 0.001). With respect to the four impact areas, an interaction was demonstrated between an intervention group and an improvement in the domain-specific functioning. The beneficial impact of the programme on these areas was associated with the improvement of physical activity only in case of full and null intervention.
CONCLUSIONS


Indicators related to the implementation process and the results obtained during the Healthy Me programme evaluation could represent a change in motivational and environmental factors that indirectly affects adolescent girl's physical activity.",2020,"The beneficial impact of the programme on these areas was associated with the improvement of physical activity only in case of full and null intervention.
","['14- to15-year-old Polish girls (N\u2009=\u20091120) from 48 random selected secondary schools participating in the 1-year Healthy Me programme in the 2017/2018', 'adolescent girls']",[],"['MVPA', 'physical activity']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0032377', 'cui_str': 'Polishes'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0036530', 'cui_str': 'Schools, Secondary'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.0196041,"The beneficial impact of the programme on these areas was associated with the improvement of physical activity only in case of full and null intervention.
","[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Mazur', 'Affiliation': 'Department of Humanization in Medicine and Sexology, University of Zielona Gora, Collegium Medicum, Zielona Gora, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Dzielska', 'Affiliation': 'Department of Child and Adolescent Health, Institute of Mother and Child, Warsaw, Poland.'}, {'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Kleszczewska', 'Affiliation': 'Foundation of the Institute of Mother and Child, Warsaw, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Oblacińska', 'Affiliation': 'Department of Child and Adolescent Health, Institute of Mother and Child, Warsaw, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Fijałkowska', 'Affiliation': 'Department of Cardiology, Institute of Mother and Child, Warsaw, Poland.'}]",European journal of public health,['10.1093/eurpub/ckz242']
3411,25712456,Early tumor shrinkage and depth of response predict long-term outcome in metastatic colorectal cancer patients treated with first-line chemotherapy plus bevacizumab: results from phase III TRIBE trial by the Gruppo Oncologico del Nord Ovest.,"BACKGROUND


Early tumor shrinkage (ETS) and depth of response (DoR) predict overall survival (OS) in first-line trials of chemotherapy ± anti-EGFR monoclonal antibodies in metastatic colorectal cancer (mCRC). These associations and the predictive accuracy of response measurements for survival parameters were investigated in the phase III TRIBE trial of FOLFOXIRI plus bevacizumab (bev) versus FOLFIRI plus bev.
PATIENTS AND METHODS


A landmark approach was adopted to define the assessable population. The distribution of RECIST response rate, ETS and DoR was compared in the two arms. Associations between response measurements and progression-free survival (PFS), post-progression survival (PPS) and OS were tested by univariate and multivariate Cox models. Prediction performance of each factor was estimated by C-index.
RESULTS


A significantly higher percentage of patients in the FOLFOXIRI plus bev arm achieved ETS ≥20%, when compared with the control arm (62.7% versus 51.9%, P = 0.025). Also the DoR was significantly higher in the triplet plus bev arm (43.4% versus 37.8%, P = 0.003). Both ETS and DoR were associated with PFS, PPS and OS at the univariate analyses and in the multivariate models stratified for other prognostic variables. Both ETS and DoR were able to predict survival as accurately as RECIST response.
CONCLUSION


FOLFOXIRI plus bev improves ETS and DoR when compared with FOLFIRI plus bev. Achieving rapid and deep tumor shrinkage consistently delays tumor progression and prolongs survival in patients treated with first-line chemotherapy plus bev. ETS is a promising and valuable end point for clinical trials' design deserving further investigation.",2015,"Both ETS and DoR were associated with PFS, PPS and OS at the univariate analyses and in the multivariate models stratified for other prognostic variables.","['metastatic colorectal cancer patients treated with', 'metastatic colorectal cancer (mCRC']","['first-line chemotherapy plus bevacizumab', 'bevacizumab', 'ETS']","['distribution of RECIST response rate, ETS and DoR', 'DoR', 'survival', 'progression-free survival (PFS), post-progression survival (PPS) and OS', 'ETS and DoR']","[{'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",,0.0772141,"Both ETS and DoR were associated with PFS, PPS and OS at the univariate analyses and in the multivariate models stratified for other prognostic variables.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cremolini', 'Affiliation': 'Unit of Medical Oncology 2, Polo Oncologico, Azienda Ospedaliero-Universitaria Pisana, Istituto Toscano Tumori, Pisa; Unit of Medical Oncology 2, University of Pisa, Pisa.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Loupakis', 'Affiliation': 'Unit of Medical Oncology 2, Polo Oncologico, Azienda Ospedaliero-Universitaria Pisana, Istituto Toscano Tumori, Pisa; Unit of Medical Oncology 2, University of Pisa, Pisa.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Antoniotti', 'Affiliation': 'Unit of Medical Oncology 2, Polo Oncologico, Azienda Ospedaliero-Universitaria Pisana, Istituto Toscano Tumori, Pisa; Unit of Medical Oncology 2, University of Pisa, Pisa.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Unit of Medical Oncology 1, Istituto Oncologico Veneto, IRCSS, Padova.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Masi', 'Affiliation': 'Unit of Medical Oncology 2, Polo Oncologico, Azienda Ospedaliero-Universitaria Pisana, Istituto Toscano Tumori, Pisa; Unit of Medical Oncology 2, University of Pisa, Pisa.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Salvatore', 'Affiliation': 'Unit of Medical Oncology 2, Polo Oncologico, Azienda Ospedaliero-Universitaria Pisana, Istituto Toscano Tumori, Pisa; Unit of Medical Oncology 2, University of Pisa, Pisa.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Cortesi', 'Affiliation': 'Department of Medical Oncology, University of Rome La Sapienza, Rome.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Tomasello', 'Affiliation': 'Division of Medicine and Medical Oncology, Azienda Istituti Ospitalieri, Cremona.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Spadi', 'Affiliation': 'Azienda Ospedaliero-Universitaria Città Della Salute e Della Scienza, Turin.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zaniboni', 'Affiliation': 'Department of Medical Oncology, Fondazione Poliambulanza, Brescia.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Tonini', 'Affiliation': 'Department of Medical Oncology, University Campus Biomedico, Rome.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Barone', 'Affiliation': 'Unit of Medical Oncology, Università Cattolica del Sacro Cuore, Rome.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Vitello', 'Affiliation': ""Unit of Oncology, Sant'Elia Hospital, Caltanissetta.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Longarini', 'Affiliation': 'Unit of Medical Oncology, San Gerardo Hospital, Monza.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bonetti', 'Affiliation': 'Unit of Medical Oncology, Mater Salutis Hospital, Legnago.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': ""D'Amico"", 'Affiliation': 'Unit of Medical Oncology, Galliera Hospital, Genoa.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Di Donato', 'Affiliation': 'Department of Medical Oncology Sandro Pitigliani, Prato Hospital, Istituto Toscano Tumori, Prato.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Granetto', 'Affiliation': 'Unit of Medical Oncology, Azienda Sanitaria Ospedaliera Santa Croce e Carle, Cuneo.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Boni', 'Affiliation': 'Clinical Trials Coordinating Center, Istituto Toscano Tumori, Firenze.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': 'Unit of Medical Oncology 2, Polo Oncologico, Azienda Ospedaliero-Universitaria Pisana, Istituto Toscano Tumori, Pisa; Unit of Medical Oncology 2, University of Pisa, Pisa. Electronic address: alfredo.falcone@med.unipi.it.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdv112']
3412,28673494,Partial Pulpotomy in Mature Permanent Teeth with Clinical Signs Indicative of Irreversible Pulpitis: A Randomized Clinical Trial.,"INTRODUCTION


This study aimed to assess the outcome of partial pulpotomy using mineral trioxide aggregate (MTA) compared with calcium hydroxide (CH) in mature cariously exposed permanent molars.
METHODS


Fifty permanent molar teeth with carious exposures in 50 patients >20 years old were included. Preoperative pulpal and periapical diagnosis was established based on a history of presenting pain, results of cold testing, and radiographic findings. After informed consent, the tooth was anesthetized, isolated via a dental dam, and disinfected with 5% sodium hypochlorite before caries excavation. Partial pulpotomy was performed by amputating 2 mm of the exposed pulp, hemostasis was achieved, and the tooth was randomly assigned for the placement of either white MTA (White ProRoot; Dentsply, Tulsa, OK) or CH (Dycal; Dentsply Caulk, Milford, DE) as the pulpotomy agent. Postoperative periapical radiographs were taken after placement of the permanent restoration. Clinical and radiographic evaluation was completed after 6 months and 1 and 2 years postoperatively. Statistical analysis was performed using the Fisher exact test.
RESULTS


Clinical signs and symptoms suggestive of irreversible pulpitis were established in all teeth. Immediate failure occurred in 4 teeth. At 1 year, MTA showed a higher tendency toward success compared with the CH group, and the difference was statistically significant after 2 years (83% vs 55%, P = .052 at 1 year; 85% vs 43%, P = .006 at 2 years). Sex did not have a statistically significant effect on the outcome.
CONCLUSIONS


MTA partial pulpotomy sustained a good success rate over the 2-year follow-up in mature permanent teeth clinically diagnosed with irreversible pulpitis. More than half of the CH cases failed within 2 years.",2017,"At 1 year, MTA showed a higher tendency toward success compared with the CH group, and the difference was statistically significant after 2 years (83% vs 55%, P = .052 at 1 year; 85% vs 43%, P = .006 at 2 years).","['mature cariously exposed permanent molars', 'Mature Permanent Teeth with Clinical Signs Indicative of Irreversible Pulpitis', '20\xa0years old were included', 'Fifty permanent molar teeth with carious exposures in 50 patients']","['Partial Pulpotomy', 'calcium hydroxide (CH', 'partial pulpotomy using mineral trioxide aggregate (MTA', 'CH']","['Immediate failure', 'Postoperative periapical radiographs', 'success rate']","[{'cui': 'C0205286', 'cui_str': 'Mature (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0348070', 'cui_str': 'Dentition, Adult'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0399406', 'cui_str': 'Irreversible pulpitis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0034104', 'cui_str': 'Pulpotomy'}, {'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}, {'cui': 'C0253527', 'cui_str': 'mineral trioxide aggregate'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0729269', 'cui_str': 'Periapical (qualifier value)'}]",50.0,0.0486561,"At 1 year, MTA showed a higher tendency toward success compared with the CH group, and the difference was statistically significant after 2 years (83% vs 55%, P = .052 at 1 year; 85% vs 43%, P = .006 at 2 years).","[{'ForeName': 'Nessrin A', 'Initials': 'NA', 'LastName': 'Taha', 'Affiliation': 'Department of Conservative Dentistry, Faculty of Dentistry, Jordan University of Science and Technology, Irbid, Jordan. Electronic address: n.taha@just.edu.jo.'}, {'ForeName': 'Mohammad A', 'Initials': 'MA', 'LastName': 'Khazali', 'Affiliation': 'Department of Conservative Dentistry, Faculty of Dentistry, Jordan University of Science and Technology, Irbid, Jordan.'}]",Journal of endodontics,['10.1016/j.joen.2017.03.033']
3413,32014581,Evaluation of the color change and tooth sensitivity in treatments that associate violet LED with carbamide peroxide 10 %: A randomized clinical trial of a split-mouth design.,"BACKGROUND


To evaluate the bleaching efficacy and post-operative sensitivity of 10 % carbamide peroxide (PC) with or without violet LED (VL).
METHODS


Thirty patients were selected and were instructed to perform home bleaching treatment using PC 10 %, for 8 h daily, for 21 days. All patients underwent in-office irradiation of only one hemiarch with VL for 30 min, twice per week for three weeks, totaling six clinical sessions of irradiation. The treatment used for each hemiarch was determined randomly. The analyses were performed at the initial time and 7, 14, and 21 days after the start of treatment and 7 and 14 days after the end of the bleaching treatment. For color analysis, digital spectrophotometry was done using the Visual Analog Scale and cold detection was performed using the thermo-sensory analysis II (TSA II) equipment. The ANOVA-two way with repeated measures and the Tukey test (α = 0.05) were used for the color and cold sensitivity analysis.
RESULTS


On analyzing the color change, it was observed that the hemiarch that was irradiated with VL presented the highest values compared with the side that did not receive irradiation. Regarding tooth sensitivity, there was no report of any patient experiencing discomfort during the bleaching protocol. Analysis of the dental thermal sensation threshold showed that the use of VL made the teeth more sensitive.
CONCLUSIONS


It can be concluded that the VL provided a positive effect on color alteration when used in conjunction with 10 % PC. However, the use of this new protocol made the teeth more sensitive.",2020,"Regarding tooth sensitivity, there was no report of any patient experiencing discomfort during the bleaching protocol.",['Thirty patients'],['10% carbamide peroxide (PC) with or without violet LED (VL'],['Visual Analog Scale and cold detection'],"[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0108342', 'cui_str': 'carbamide peroxide'}, {'cui': 'C0330463', 'cui_str': 'Violet'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}]",30.0,0.0270886,"Regarding tooth sensitivity, there was no report of any patient experiencing discomfort during the bleaching protocol.","[{'ForeName': 'Marjorie de Oliveira', 'Initials': 'MO', 'LastName': 'Gallinari', 'Affiliation': 'Department of Restorative Dentistry, Araçatuba School of Dentistry, São Paulo State University - UNESP, Araçatuba, SP, Brazil. Electronic address: marjo_oliveira@hotmail.com.'}, {'ForeName': 'Luciano Tavares Angelo', 'Initials': 'LTA', 'LastName': 'Cintra', 'Affiliation': 'Department of Restorative Dentistry, Araçatuba School of Dentistry, São Paulo State University - UNESP, Araçatuba, SP, Brazil. Electronic address: luciano.cintra@unesp.br.'}, {'ForeName': 'Ana Carolina Souza', 'Initials': 'ACS', 'LastName': 'Barboza', 'Affiliation': 'Department of Restorative Dentistry, Araçatuba School of Dentistry, São Paulo State University - UNESP, Araçatuba, SP, Brazil. Electronic address: anacarolinasbarboza@gmail.com.'}, {'ForeName': 'Lívia Maria Alves Valentim', 'Initials': 'LMAV', 'LastName': 'da Silva', 'Affiliation': 'Department of Restorative Dentistry, Araçatuba School of Dentistry, São Paulo State University - UNESP, Araçatuba, SP, Brazil. Electronic address: lliviaa@hotmail.com.'}, {'ForeName': 'Sibele', 'Initials': 'S', 'LastName': 'de Alcantara', 'Affiliation': 'Department of Restorative Dentistry, Araçatuba School of Dentistry, São Paulo State University - UNESP, Araçatuba, SP, Brazil. Electronic address: sibelealcantara@gmail.com.'}, {'ForeName': 'Paulo Henrique', 'Initials': 'PH', 'LastName': 'Dos Santos', 'Affiliation': 'Department of Dental Materials and Prosthodontics, Araçatuba School of Dentistry, São Paulo State University - UNESP, Araçatuba, SP, Brazil. Electronic address: Paulo.santos@unesp.br.'}, {'ForeName': 'Ticiane Cestari', 'Initials': 'TC', 'LastName': 'Fagundes', 'Affiliation': 'Department of Restorative Dentistry, Araçatuba School of Dentistry, São Paulo State University - UNESP, Araçatuba, SP, Brazil. Electronic address: ticiane.fagundes@unesp.br.'}, {'ForeName': 'André Luiz Fraga', 'Initials': 'ALF', 'LastName': 'Briso', 'Affiliation': 'Department of Restorative Dentistry, Araçatuba School of Dentistry, São Paulo State University - UNESP, Araçatuba, SP, Brazil. Electronic address: andre.briso@unesp.br.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101679']
3414,32015256,Mobile Electrocardiogram Monitoring and Health-Related Quality of Life in Patients With Atrial Fibrillation: Findings From the iPhone Helping Evaluate Atrial Fibrillation Rhythm Through Technology (iHEART) Study.,"BACKGROUND


Atrial fibrillation (AF) is associated with high recurrence rates and poor health-related quality of life (HRQOL) but few effective interventions to improve HRQOL exist.
OBJECTIVE


The aim of this study was to examine the impact of the ""iPhone Helping Evaluate Atrial Fibrillation Rhythm through Technology"" (iHEART) intervention on HRQOL in patients with AF.
METHODS


We randomized English- and Spanish-speaking adult patients with AF to receive either the iHEART intervention or usual care for 6 months. The iHEART intervention used smartphone-based electrocardiogram monitoring and motivational text messages. Three instruments were used to measure HRQOL: the Atrial Fibrillation Effect on Quality of Life (AFEQT), the 36-item Short-Form Health survey, and the EuroQol-5D. We used linear mixed models to compare the effect of the iHEART intervention on HRQOL, quality-adjusted life-years, and AF symptom severity.
RESULTS


A total of 238 participants were randomized to the iHEART intervention (n = 115) or usual care (n = 123). Of the participants, 77% were men and 76% were white. More than half (55%) had an AF recurrence. Both arms had improved scores from baseline to follow-up for AFEQT and AF symptom severity scores. The global AFEQT score improved 18.5 and 11.2 points in the intervention and control arms, respectively (P < .05). There were no statistically significant differences in HRQOL, quality-adjusted life-years, or AF symptom severity between groups.
CONCLUSIONS


We found clinically meaningful improvements in AF-specific HRQOL and AF symptom severity for both groups. Additional research with longer follow-up should examine the influence of smartphone-based interventions for AF management on HRQOL and address the unique needs of patients diagnosed with different subtypes of AF.",2020,"The global AFEQT score improved 18.5 and 11.2 points in the intervention and control arms, respectively (P < .05).","['Patients With Atrial Fibrillation', '238 participants', 'Spanish-speaking adult patients with AF to receive either the', 'n = 115) or usual care (n = 123', 'Of the participants, 77% were men and 76% were white', 'patients with AF']","['iHEART intervention', 'Technology"" (iHEART) intervention', 'smartphone-based electrocardiogram monitoring and motivational text messages', 'iHEART intervention or usual care for 6 months']","['HRQOL, quality-adjusted life-years, and AF symptom severity', 'AF recurrence', 'Mobile Electrocardiogram Monitoring and Health-Related Quality of Life', 'global AFEQT score', 'HRQOL, quality-adjusted life-years, or AF symptom severity', 'AF-specific HRQOL and AF symptom severity', 'HRQOL: the Atrial Fibrillation Effect on Quality of Life (AFEQT), the 36-item Short-Form Health survey, and the EuroQol-5D']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}]",238.0,0.0718041,"The global AFEQT score improved 18.5 and 11.2 points in the intervention and control arms, respectively (P < .05).","[{'ForeName': 'Billy A', 'Initials': 'BA', 'LastName': 'Caceres', 'Affiliation': 'Billy A. Caceres, PhD, RN, AGPCNP-BC Assistant Professor, Columbia University School of Nursing, New York, New York. Kathleen T. Hickey, EdD, FNP, ANP, FAHA, FAAN Professor of Nursing, Columbia University School of Nursing, New York, New York. Suzanne B. Bakken, PhD, RN, FAAN, FACMI Professor of Biomedical Informatics and Alumni Professor of the School of Nursing, Columbia University School of Nursing, New York, New York. Angelo B. Biviano, MD, MPH Associate Professor of Medicine, Columbia University Irving Medical Center, New York, New York. Hasan Garan, MD Dickinson W. Richards, Jr. Professor of Medicine, Columbia University Irving Medical Center, New York, New York. Isaac L. Goldenthal, MS Clinical Research Coordinator, Columbia University Irving Medical Center, New York, New York. Theresa A. Koleck, PhD, RN Associate Research Scientist, Columbia University School of Nursing, New York, New York. Ruth Masterson-Creber, PhD, MPH, RN, FAHA Assistant Professor of Healthcare Policy and Research, Weill Cornell Medical College, New York, New York. Meghan Reading Turchioe, PhD, MPH, RN Postdoctoral Researcher in Health Informatics, Weill Cornell Medical College, New York, New York. Haomiao Jia, PhD Professor of Biostatistics (in Nursing), Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Kathleen T', 'Initials': 'KT', 'LastName': 'Hickey', 'Affiliation': ''}, {'ForeName': 'Suzanne B', 'Initials': 'SB', 'LastName': 'Bakken', 'Affiliation': ''}, {'ForeName': 'Angelo B', 'Initials': 'AB', 'LastName': 'Biviano', 'Affiliation': ''}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Garan', 'Affiliation': ''}, {'ForeName': 'Isaac L', 'Initials': 'IL', 'LastName': 'Goldenthal', 'Affiliation': ''}, {'ForeName': 'Theresa A', 'Initials': 'TA', 'LastName': 'Koleck', 'Affiliation': ''}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Masterson-Creber', 'Affiliation': ''}, {'ForeName': 'Meghan Reading', 'Initials': 'MR', 'LastName': 'Turchioe', 'Affiliation': ''}, {'ForeName': 'Haomiao', 'Initials': 'H', 'LastName': 'Jia', 'Affiliation': ''}]",The Journal of cardiovascular nursing,['10.1097/JCN.0000000000000646']
3415,31519277,"The add-on effect of dengzhan shengmai capsules on secondary prevention of ischemic stroke: A multicentre, randomised, placebo-controlled clinical trial.","OBJECTIVE


The Dengzhan Shengmai (DZSM) capsule is a commercially available type of Chinese herbal medicine frequently administered to improve neurological impairment after stroke. Its ability to prevent recurrent stroke, however, has not been determined. This study therefore evaluated the ability of DZSM as an add-on to conventional secondary preventive agents to prevent recurrent ischemic stroke.
METHODS


In this randomised, double-blind, placebo-controlled trial, conducted at 83 hospitals in Mainland China, 3143 patients in 14-180 days after the initial onset of ischemic stroke, were randomly allocated to the DZSM (0.36 g, twice daily for 12 months) or the placebo group. All patients in both groups received standard secondary preventive medications. The primary outcome was the 1-year incidence of stroke. Between group differences were assessed using the Cox proportional hazards model.
RESULTS


Intent-to-treat analysis showed that 58 (3.8%) participants in the DZSM group and 82 (5.4%) in the placebo group experienced new stroke events (hazard ratio = 0.70, 95% confidence interval = 0.50-0.98, P = 0.036). The type and incidence of adverse events were similar in the DZSM and placebo groups.
CONCLUSIONS


The addition of DZSM capsules to standard secondary preventive agents provides additional benefits after the initial onset of ischemic stroke, reducing recurrent stroke without increasing severe adverse events. However, further study is needed to elucidate the role of DZSM on the updated practice of conventional secondary prevention for ischemic stroke.",2019,"The type and incidence of adverse events were similar in the DZSM and placebo groups.
","['83 hospitals in Mainland China, 3143 patients in 14-180 days after the initial onset of ischemic stroke']","['DZSM', 'standard secondary preventive medications', 'dengzhan shengmai capsules', 'placebo', 'Dengzhan Shengmai (DZSM) capsule']","['adverse events', '1-year incidence of stroke', 'new stroke events', 'ischemic stroke']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C3885966', 'cui_str': 'shengmai'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4506831', 'cui_str': 'dengzhan shengmai capsule'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}]",3143.0,0.706246,"The type and incidence of adverse events were similar in the DZSM and placebo groups.
","[{'ForeName': 'Yefeng', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': 'Guangdong Provincial Hospital of Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences, The Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou, 510120, China.'}, {'ForeName': 'Xiaoyun', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Guangdong Provincial Hospital of Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences, The Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou, 510120, China. Electronic address: gdszyyhy@163.com.'}, {'ForeName': 'Lixin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Guangdong Provincial Hospital of Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences, The Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou, 510120, China.'}, {'ForeName': 'Jingbo', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Guangdong Provincial Hospital of Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences, The Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou, 510120, China.'}, {'ForeName': 'Weixiong', 'Initials': 'W', 'LastName': 'Liang', 'Affiliation': 'Guangdong Provincial Hospital of Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences, The Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou, 510120, China.'}, {'ForeName': 'Aihua', 'Initials': 'A', 'LastName': 'Ou', 'Affiliation': 'Guangdong Provincial Hospital of Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences, The Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou, 510120, China.'}, {'ForeName': 'Baili', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': 'Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China.'}, {'ForeName': 'Jianwen', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Guangdong Provincial Hospital of Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences, The Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou, 510120, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Guangdong Provincial Hospital of Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences, The Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou, 510120, China.'}, {'ForeName': 'Xiaojia', 'Initials': 'X', 'LastName': 'Ni', 'Affiliation': 'Guangdong Provincial Hospital of Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences, The Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou, 510120, China.'}, {'ForeName': 'Shaohong', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China. Electronic address: chensh680@163.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2019.08.015']
3416,32016680,Changes in quality of life and sleep across the perinatal period in women with mood disorders.,"INTRODUCTION


The perinatal period represents a time of significant life changes associated with increases in sleep difficulties, depression, and potentially impaired quality of life (QoL). Associations between QoL and sleep among women with perinatal depression are poorly understood, and changes in QoL across the perinatal period have received little attention.
METHODS


Participants were the treatment-as-usual group (n = 23) from a clinical trial testing an intervention for perinatal mood disorders. They completed the WHOQOL-Bref, had depression assessed with the HAM-D-17, and wore wrist actigraphs to estimate sleep for 1 week during third trimester and at 6 weeks postpartum.
RESULTS


Higher education level was associated with better environmental QoL during pregnancy (p = .044) and presence of older children was associated with worse social QoL postpartum (p = .045). Psychological health QoL worsened (p = .014) across the perinatal period. Total sleep time (p = .001) and sleep efficiency (p = .008) decreased from third trimester to postpartum week 6, but sleep measures were not associated with QoL at either time point. Depressive symptoms decreased from pregnancy to postpartum week 6 and were inversely associated with postpartum physical and social QoL (p = .031 and .048).
DISCUSSION


Factors contributing to self-rated QoL are variable across multiple domains during the perinatal period. QoL among our participants was lower than population norms. In our sample of women with depression and/or anxiety, QoL was related to postpartum depressive symptoms, but not to objectively measured sleep quality, quantity, or timing. Links between QoL and sleep may be inherently complex in perinatal women.",2020,Total sleep time (p = .001) and sleep efficiency,"['women with perinatal depression', 'women with mood disorders', 'Participants were the treatment-as-usual group (n\u2009=\u200923) from a clinical trial testing an intervention for perinatal mood disorders']",[],"['sleep efficiency', 'environmental QoL', 'worse social QoL postpartum', 'sleep difficulties, depression, and potentially impaired quality of life (QoL', 'quality of life and sleep', 'Total sleep time', 'Psychological health QoL', 'Depressive symptoms', 'postpartum physical and social QoL']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4284586', 'cui_str': 'Perinatal depression'}, {'cui': 'C0525045', 'cui_str': 'Affective Disorders'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",[],"[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}]",,0.0500581,Total sleep time (p = .001) and sleep efficiency,"[{'ForeName': 'A W', 'Initials': 'AW', 'LastName': 'Kang', 'Affiliation': 'Brown University, Providence, RI, USA.'}, {'ForeName': 'T B', 'Initials': 'TB', 'LastName': 'Pearlstein', 'Affiliation': 'Brown University, Providence, RI, USA.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Sharkey', 'Affiliation': 'Brown University, Providence, RI, USA. Katherine_Sharkey@brown.edu.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-020-02437-1']
3417,19282468,Quality of life and disease-related symptoms in previously treated Japanese patients with non-small-cell lung cancer: results of a randomized phase III study (V-15-32) of gefitinib versus docetaxel.,"BACKGROUND


This report describes quality of life (QoL) findings of a randomized study comparing gefitinib with docetaxel in patients with advanced/metastatic pretreated non-small-cell lung cancer.
PATIENTS AND METHODS


This open-label, phase III study randomized 490 Japanese patients to gefitinib (250 mg/day) or docetaxel (60 mg/m(2)/3 weeks), with survival as the primary outcome. Preplanned QoL analyses included Functional Assessment of Cancer Therapy-Lung (FACT-L), Trial Outcome Index (TOI) and Lung Cancer Subscale (LCS) improvement rates, and mean change from baseline.
RESULTS


Gefitinib showed statistically significant benefits over docetaxel in QoL improvement rates (FACT-L 23% versus 14%, P = 0.023; TOI 21% versus 9%, P = 0.002) and mean change from baseline score [mean treatment difference: FACT-L 3.72 points, 95% confidence interval (CI) 0.55-6.89, P = 0.022; TOI 4.31 points, 95% CI 2.13-6.49, P < 0.001], although differences did not meet the clinically relevant six-point change. There were no significant differences between treatments in LCS improvement rates (23% versus 20%, P = 0.562) or mean change from baseline score (0.63 points, 95% CI -0.07 to 1.34, P = 0.077).
CONCLUSIONS


Gefitinib improved aspects of QoL over docetaxel, with superior objective response rate and a more favorable tolerability profile and no statistically significant difference in overall survival (although noninferiority was not statistically proven).",2009,"There were no significant differences between treatments in LCS improvement rates (23% versus 20%, P = 0.562) or mean change from baseline score (0.63 points, 95% CI -0.07 to 1.34, P = 0.077).
","['patients with advanced/metastatic pretreated non-small-cell lung cancer', 'previously treated Japanese patients with non-small-cell lung cancer', '490 Japanese patients to']","['gefitinib with docetaxel', 'gefitinib', 'gefitinib versus docetaxel', 'docetaxel']","['Functional Assessment of Cancer Therapy-Lung', 'LCS improvement rates', 'Quality of life and disease-related symptoms', 'overall survival', 'QoL improvement rates', 'Trial Outcome Index (TOI) and Lung Cancer Subscale (LCS) improvement rates, and mean change from baseline']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}]","[{'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0034380'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",490.0,0.122108,"There were no significant differences between treatments in LCS improvement rates (23% versus 20%, P = 0.562) or mean change from baseline score (0.63 points, 95% CI -0.07 to 1.34, P = 0.077).
","[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Sekine', 'Affiliation': 'Division of Internal Medicine and Thoracic Oncology, National Cancer Center Hospital, Tokyo. Electronic address: isekine@ncc.go.jp.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Ichinose', 'Affiliation': 'Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Nishiwaki', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital East, Chiba.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Tsuboi', 'Affiliation': 'Department of Thoracic Surgery and Oncology, Tokyo Medical University Hospital, Tokyo.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Medical Oncology, Kinki University School of Medicine, Osaka.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Shinkai', 'Affiliation': 'Department of Internal Medicine, Respiratory Division, NHO Shikoku Cancer Center, Ehime.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Negoro', 'Affiliation': 'Department of Thoracic Oncology, Hyogo Cancer Center, Hyogo.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Imamura', 'Affiliation': 'Department of Pulmonary Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Eguchi', 'Affiliation': 'Department of Internal Medicine and Medical Oncology, Teikyo University School of Medicine, Kanagawa.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Takeda', 'Affiliation': 'Department of Clinical Oncology, Osaka City General Hospital, Osaka.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Itoh', 'Affiliation': 'Clinical Division, Research and Development, AstraZeneca KK, Osaka, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Tamura', 'Affiliation': 'Division of Internal Medicine and Thoracic Oncology, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Saijo', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital East, Chiba.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fukuoka', 'Affiliation': 'Department of Medical Oncology, Kinki University School of Medicine, Osaka.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp031']
3418,32013568,Short-Term Intermittent Hypoxic Resistance Training Does Not Impair Osteogenic Response in Sea Level Residents.,"Background:  Osteogenic responses induced by training under hypoxia remain unclear. We aimed to investigate whether intermittent hypoxic resistance training affects osteogenic responses.  Materials and Methods:  Sixteen male participants underwent resistance training under normoxia (NRT;  n  = 7) or hypoxia (HRT; O 2  = 14.4%,  n  = 9), twice a week for 8 weeks. The HRT group exercised and rested for 30 minutes under hypoxia, with total hypoxic exposure time in one session of ∼60 minutes. At pre- and postexperiment, bone mineral density (BMD) of the whole body and right proximal femur was measured. At the first and last training sessions, bone alkaline phosphatase (BAP), osteocalcin (OC), cross-linked N-telopeptide of type I collagen (NTx), type I collagen cross-linked C-telopeptide (ICTP), interleukin-6 (IL-6), and blood lactate (La) concentration were analyzed at rest and postexercise.  Results:  BMD did not change with training and hypoxia. Although BAP, OC, and ICTP levels at rest significantly increased with training ( p  < 0.01, 0.05, and 0.05, respectively), they did not change with hypoxia. NTx and IL-6 did not change. Additionally, changing patterns of bone markers and La induced by a single bout of exercise were similar among groups in both training sessions.  Conclusions:  Short-term resistance training enhanced overall bone metabolism, regardless of the oxygen level. Hypoxia has no effects on osteogenic responses.",2020,"Although BAP, OC, and ICTP levels at rest significantly increased with training ( p  < 0.01, 0.05, and 0.05, respectively), they did not change with hypoxia.","['Sixteen male participants underwent', 'Sea Level Residents']","['resistance training under normoxia (NRT;  n \u2009=\u20097) or hypoxia (HRT', 'intermittent hypoxic resistance training', 'Short-Term Intermittent Hypoxic Resistance Training']","['I collagen (NTx), type I collagen cross-linked C-telopeptide (ICTP), interleukin-6 (IL-6), and blood lactate ', 'La) concentration', 'BMD', 'osteogenic responses', 'overall bone metabolism', 'bone mineral density (BMD) of the whole body and right proximal femur', 'BAP, OC, and ICTP levels', 'bone alkaline phosphatase (BAP), osteocalcin (OC', 'NTx and IL-6']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0036493', 'cui_str': 'Sea (environment)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy (procedure)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]","[{'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0908518', 'cui_str': '5-((76)Br)bromo-3-((2-azetidinyl)methoxy)pyridine'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1868883', 'cui_str': 'Bone alkaline phosphatase'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}]",16.0,0.0188146,"Although BAP, OC, and ICTP levels at rest significantly increased with training ( p  < 0.01, 0.05, and 0.05, respectively), they did not change with hypoxia.","[{'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Honda', 'Affiliation': 'Department of Health and Sport Sciences, School of Health Sciences, Asahi University, Mizuho, Japan.'}, {'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Kon', 'Affiliation': 'School of International Liberal Studies, Chukyo University, Nagoya, Japan.'}, {'ForeName': 'Takeo', 'Initials': 'T', 'LastName': 'Matsubayashi', 'Affiliation': 'Department of Sports Sciences, Japan Institute of Sports Sciences, Kita-ku, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Department of Sports Sciences, Japan Institute of Sports Sciences, Kita-ku, Japan.'}]",High altitude medicine & biology,['10.1089/ham.2019.0089']
3419,17442659,Oral ibandronate is as active as intravenous zoledronic acid for reducing bone turnover markers in women with breast cancer and bone metastases.,"BACKGROUND


Phase III study comparing the effect of oral ibandronate and intravenous zoledronic acid on bone markers.
PATIENTS AND METHODS


Breast cancer patients with bone metastases received ibandronate 50 mg/day (n = 137) or zoledronic acid 4 mg every 4 weeks (n = 138) for 12 weeks. The primary end point was mean percentage change in serum levels of cross-linked C-terminal telopeptide of type I collagen (S-CTX) at week 12. Urinary CTX (U-CTX), bone alkaline phosphatase (ALP), amino-terminal procollagen propeptide of type I collagen (PINP) and osteocalcin (OC) were also measured and bone pain and safety assessed.
RESULTS


Both bisphosphonates significantly reduced S-CTX (mean ibandronate 76% +/- 29 (SD) versus mean zoledronic acid 73% +/- 47; P < 0.001 for both versus baseline) and U-CTX (ibandronate 78% +/- 50 versus zoledronic acid 86% +/- 17; P < 0.001). The difference in S-CTX between treatments was 0.6% (confidence interval -1.7% to 3.0%), which was within the prespecified noninferiority margin. Bone ALP, PINP and OC decreased by 26%-47% compared with baseline with both bisphosphonates. Compared with zoledronic acid, ibandronate patients reported fewer adverse events overall (65.0% versus 75.9%), and on days 1-3 (8.0% versus 47.5%), including less pyrexia (overall incidence 0% versus 16.8%) and bone pain (5.8% versus 12.4%).
CONCLUSIONS


Oral ibandronate was well tolerated and statistically noninferior to zoledronic acid for percentage change in the bone resorption marker, S-CTX.",2007,"Bone ALP, PINP and OC decreased by 26%-47% compared with baseline with both bisphosphonates.","['Breast cancer patients with bone metastases received ibandronate 50 mg/day (n = 137) or', 'women with breast cancer and bone metastases']","['zoledronic acid', 'oral ibandronate and intravenous zoledronic acid', 'bisphosphonates']","['mean percentage change in serum levels of cross-linked C-terminal telopeptide of type I collagen (S-CTX', 'adverse events overall', 'Urinary CTX (U-CTX), bone alkaline phosphatase (ALP), amino-terminal procollagen propeptide of type', 'bone pain', 'bone turnover markers', 'I collagen (PINP) and osteocalcin (OC', 'bone pain and safety assessed', 'S-CTX', 'pyrexia', 'Bone ALP, PINP and OC']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0379199', 'cui_str': 'Ibandronate'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0379199', 'cui_str': 'Ibandronate'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C1101784', 'cui_str': 'COOH-terminal telopeptide of type I collagen'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1868883', 'cui_str': 'Bone alkaline phosphatase'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0151825', 'cui_str': 'Bone pain (finding)'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0262950', 'cui_str': 'Bones'}]",138.0,0.174116,"Bone ALP, PINP and OC decreased by 26%-47% compared with baseline with both bisphosphonates.","[{'ForeName': 'J-J', 'Initials': 'JJ', 'LastName': 'Body', 'Affiliation': 'Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium. jj.body@bordet.be'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lichinitser', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tjulandin', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Garnero', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bergström', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,[]
3420,15598948,Cologne high-dose sequential chemotherapy in relapsed and refractory Hodgkin lymphoma: results of a large multicenter study of the German Hodgkin Lymphoma Study Group (GHSG).,"BACKGROUND


We designed a dose- and time-intensified high-dose sequential chemotherapy regimen for patients with relapsed and refractory Hodgkin lymphoma (HD).
PATIENTS AND METHODS


Eligibility criteria included age 18-65 years, histologically proven primary progressive (PD) or relapsed HD. Treatment consisted of two cycles DHAP (dexamethasone, high-dose cytarabine, cisplatinum); patients with chemosensitive disease received cyclophosphamide followed by peripheral blood stem cell harvest; methotrexate plus vincristine, etoposide and BEAM plus peripheral blood stem cell transplantation (PBSCT).
RESULTS


A total of 102 patients (median age 34 years, range 18-64) were enrolled. The response rate was 80% (72% complete response, 8% partial response). With a median follow-up of 30 months (range 3-61 months), freedom from second failure (FF2F) and overall survival (OS) were 59% and 78% for all patients, respectively. FF2F and OS for patients with early relapse were 62% and 81%, for late relapse 65% and 81%; for PD 41% and 48%, and for multiple relapse 39% and 48%, respectively. In multivariate analysis response after DHAP (P <0.0001) and duration of first remission (PD and multiple relapse versus early and late relapse; P=0.0127) were prognostic factors for FF2F. Response after DHAP (P <0.0081), duration of first remission (P=0.0017) and anemia (P=0.019) were significant for OS.
CONCLUSION


Based on the promising results of this study, a prospective randomized European intergroup study was started comparing this intensified regimen with two courses of DHAP followed by BEAM (HD-R2 protocol).",2005,"In multivariate analysis response after DHAP (P <0.0001) and duration of first remission (PD and multiple relapse versus early and late relapse; P=0.0127) were prognostic factors for FF2F. Response after DHAP (P <0.0081), duration of first remission (P=0.0017) and anemia (P=0.019) were significant for OS.
","['relapsed and refractory Hodgkin lymphoma', 'patients with chemosensitive disease received', 'patients with relapsed and refractory Hodgkin lymphoma (HD', 'Eligibility criteria included age 18-65 years, histologically proven primary progressive (PD) or relapsed HD', '102 patients (median age 34 years, range 18-64) were enrolled', 'German Hodgkin Lymphoma Study Group (GHSG']","['cyclophosphamide followed by peripheral blood stem cell harvest; methotrexate plus vincristine, etoposide and BEAM plus peripheral blood stem cell transplantation (PBSCT', 'DHAP followed by BEAM (HD-R2 protocol', 'DHAP (dexamethasone, high-dose cytarabine, cisplatinum', 'Cologne high-dose sequential chemotherapy']","['freedom from second failure (FF2F) and overall survival (OS', 'response rate', 'FF2F and OS', 'duration of first remission (PD and multiple relapse', 'anemia', 'duration of first remission']","[{'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C1266193', 'cui_str': 'Hodgkin lymphoma - category (morphologic abnormality)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0457411', 'cui_str': 'Harvesting of peripheral blood stem cells'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0242602', 'cui_str': 'Peripheral Stem Cell Transplantation'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",102.0,0.039259,"In multivariate analysis response after DHAP (P <0.0001) and duration of first remission (PD and multiple relapse versus early and late relapse; P=0.0127) were prognostic factors for FF2F. Response after DHAP (P <0.0081), duration of first remission (P=0.0017) and anemia (P=0.019) were significant for OS.
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Josting', 'Affiliation': 'First Department of Internal Medicine, University Hospital Cologne, Germany. andreas.josting@uni-koeln.de'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rudolph', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mapara', 'Affiliation': ''}, {'ForeName': 'J-P', 'Initials': 'JP', 'LastName': 'Glossmann', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sieniawski', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sienawski', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sieber', 'Affiliation': ''}, {'ForeName': 'H H', 'Initials': 'HH', 'LastName': 'Kirchner', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Dörken', 'Affiliation': ''}, {'ForeName': 'D K', 'Initials': 'DK', 'LastName': 'Hossfeld', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kisro', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Metzner', 'Affiliation': ''}, {'ForeName': 'W E', 'Initials': 'WE', 'LastName': 'Berdel', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Diehl', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Engert', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,[]
3421,31313093,eHealth Interventions for Early Infant Diagnosis: Mothers' Satisfaction with the HIV Infant Tracking System in Kenya.,"The HIV Infant Tracking System (HITSystem) is an eHealth intervention to improve early infant diagnosis (EID) through alerts to providers and text messages to mothers. This study explored mothers' experiences receiving standard and HITSystem-enhanced EID services to assess perceived intervention benefits, acceptability, and opportunities for improvement. This qualitative study was embedded within a cluster-randomized control trial to evaluate the HITSystem at six Kenyan government hospitals (3 intervention, 3 control). We conducted semi-structured interviews with 137 mothers attending EID follow-up visits. Compared to control sites, participants at HITSystem sites described enhanced EID quality; HITSystem-generated texts informed them of result availability and retesting needs, provided cues-to-action for clinic attendance, and engendered opportunities for patient support. They described improved EID efficiency through shorter waiting periods for results and fewer hospital visits. Participants reported high satisfaction with EID and acceptability of text messages; however, modifications to ensure text delivery, increase repeat testing reminders, include low literacy content options, and provide encouraging messages were suggested. These user experience data suggest improvements in EID at HITSystem sites when compared with control sites.",2019,"Compared to control sites, participants at HITSystem sites described enhanced EID quality; HITSystem-generated texts informed them of result availability and retesting needs, provided cues-to-action for clinic attendance, and engendered opportunities for patient support.","[""Early Infant Diagnosis: Mothers' Satisfaction with the HIV Infant Tracking System in Kenya"", '137 mothers attending EID follow-up visits', ""mothers' experiences receiving""]",['standard and HITSystem-enhanced EID services'],['EID efficiency'],"[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1738334', 'cui_str': 'Tracking system'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit (procedure)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0013682', 'cui_str': 'Efficiency'}]",137.0,0.055461,"Compared to control sites, participants at HITSystem sites described enhanced EID quality; HITSystem-generated texts informed them of result availability and retesting needs, provided cues-to-action for clinic attendance, and engendered opportunities for patient support.","[{'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': 'Department of Family Medicine, University of Kansas Medical Center, 3901 Rainbow Blvd., Kansas City, KS, 66160, USA. mbrown38@kumc.edu.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Wexler', 'Affiliation': 'Department of Family Medicine, University of Kansas Medical Center, 3901 Rainbow Blvd., Kansas City, KS, 66160, USA.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Gautney', 'Affiliation': 'Global Health Innovations, Dallas, TX, USA.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Goggin', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Hurley', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Beryne', 'Initials': 'B', 'LastName': 'Odeny', 'Affiliation': 'Department of Family Medicine, University of Kansas Medical Center, 3901 Rainbow Blvd., Kansas City, KS, 66160, USA.'}, {'ForeName': 'May', 'Initials': 'M', 'LastName': 'Maloba', 'Affiliation': 'Global Health Innovations, Nairobi, Kenya.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Lwembe', 'Affiliation': 'Centre for Virus Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Sandbulte', 'Affiliation': 'Department of Family Medicine, University of Kansas Medical Center, 3901 Rainbow Blvd., Kansas City, KS, 66160, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Finocchario-Kessler', 'Affiliation': 'Department of Family Medicine, University of Kansas Medical Center, 3901 Rainbow Blvd., Kansas City, KS, 66160, USA.'}]",AIDS and behavior,['10.1007/s10461-019-02579-5']
3422,31994752,Advanced decision-making using patient-reported outcome measures in total joint replacement.,"Up to one-third of total joint replacement (TJR) procedures may be performed inappropriately in a subset of patients who remain dissatisfied with their outcomes, stressing the importance of shared decision-making. Patient-reported outcome measures capture physical, emotional, and social aspects of health and wellbeing from the patient's perspective. Powerful computer systems capable of performing highly sophisticated analysis using different types of data, including patient-derived data, such as patient-reported outcomes, may eliminate guess work, generating impactful metrics to better inform the decision-making process. We have created a shared decision-making tool which generates personalized predictions of risks and benefits from TJR based on patient-reported outcomes as well as clinical and demographic data. We present the protocol for a randomized controlled trial designed to assess the impact of this tool on decision quality, level of shared decision-making, and patient and process outcomes. We also discuss current concepts in this field and highlight opportunities leveraging patient-reported data and artificial intelligence for decision support across the care continuum.",2020,"Powerful computer systems capable of performing highly sophisticated analysis using different types of data, including patient-derived data, such as patient-reported outcomes, may eliminate guess work, generating impactful metrics to better inform the decision making process.",[],['total joint replacement (TJR) procedures'],"['capture physical, emotional and social aspects of health and wellbeing', 'Total Joint Replacement']",[],"[{'cui': 'C4279925', 'cui_str': 'Total Joint Replacement'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4279925', 'cui_str': 'Total Joint Replacement'}]",,0.0738654,"Powerful computer systems capable of performing highly sophisticated analysis using different types of data, including patient-derived data, such as patient-reported outcomes, may eliminate guess work, generating impactful metrics to better inform the decision making process.","[{'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Jayakumar', 'Affiliation': 'Department of Surgery and Perioperative Care, Dell Medical School, University of Texas at Austin, Austin, Texas.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Bozic', 'Affiliation': 'Department of Surgery and Perioperative Care, Dell Medical School, University of Texas at Austin, Austin, Texas.'}]",Journal of orthopaedic research : official publication of the Orthopaedic Research Society,['10.1002/jor.24614']
3423,19451183,"A prospective, randomised study on the use of well-fitting masks for prevention of invasive aspergillosis in high-risk patients.","The problem of inhalation of Aspergillus spores outside rooms with high-efficiency particulate air (HEPA) filtration has not been resolved as yet. Well-fitting masks are used in industrial and health care settings to protect from inhaling particles of 0.3-0.5 mum size. To investigate the efficacy and tolerability of well-fitting masks in high-risk patients, we conducted a prospective, randomised, multicentre study comparing standard hospital hygiene procedures with or without wearing masks in adults undergoing chemotherapy for acute leukaemia or allogeneic haematopoietic stem-cell transplantation (aHSCT). Forty-one patients were randomly assigned to wearing masks and 39 to the control group. In all, 76% of patients were treated in laminar airflow or HEPA-filtered rooms, 84% received oral polyenes, and three aHSCT recipients were given fluconazole. Duration of neutropenia was similar in both treatment groups. Invasive fungal infections were diagnosed in eight patients in either study arm. One patient in each arm died from proven invasive aspergillosis. There was no difference in the use of systemic antifungals. Of patients in the mask group, 65% described the comfort as acceptable, 26% as unpleasant, and 9% as intolerable. This first randomised study on the use of well-fitting masks failed to show a reduction of invasive fungal infections.",2009,Duration of neutropenia was similar in both treatment groups.,"['high-risk patients', 'Forty-one patients', 'adults undergoing chemotherapy for acute leukaemia or allogeneic haematopoietic stem-cell transplantation (aHSCT']","['aHSCT', 'well-fitting masks', 'standard hospital hygiene procedures with or without wearing masks', 'fluconazole']","['efficacy and tolerability', 'Duration of neutropenia', 'invasive fungal infections', 'Invasive fungal infections']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia, morphology, including blast cell OR undifferentiated leukemia (morphologic abnormality)'}, {'cui': 'C0018956', 'cui_str': 'Progenitor Cells, Hematopoietic'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C1262313', 'cui_str': 'Invasive Mycoses'}]",41.0,0.0274907,Duration of neutropenia was similar in both treatment groups.,"[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Maschmeyer', 'Affiliation': 'Department of Haematology and Oncology, Ernst-von-Bergmann Clinic, Potsdam. Electronic address: gmaschmeyer@klinikumevb.de.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Neuburger', 'Affiliation': 'Department of Haematology and Oncology, Charité University Medical School, Campus Virchow-Klinikum, Berlin.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Fritz', 'Affiliation': 'Department of Haematology and Oncology, Ernst-von-Bergmann Clinic, Potsdam.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Böhme', 'Affiliation': 'Department of Internal Medicine II, Johann-Wolfgang-Goethe-University Medical Centre, Frankfurt am Main.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Penack', 'Affiliation': 'Department of Haematology and Oncology, Charité University Medical School, Campus Benjamin Franklin, Berlin.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Schwerdtfeger', 'Affiliation': 'Centre for Bone Marrow and Stem Cell Transplantation, German Diagnostic Clinic DKD, Wiesbaden.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Buchheidt', 'Affiliation': 'Department of Internal Medicine III, University Medical School Mannheim, Ruprecht-Karls-University of Heidelberg, Mannheim.'}, {'ForeName': 'W-D', 'Initials': 'WD', 'LastName': 'Ludwig', 'Affiliation': 'Department of Haematology, Oncology and Tumour Immunology, Robert Roessle-Clinic, Helios Clinic Berlin-Buch, Charité University Medical School, Berlin, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp034']
3424,32006650,Could photodynamic therapy be utilized as a treatment modality for oral lichen planus?,"BACKGROUND


Oral lichen planus (OLP) is a chronic inflammatory disease. There is no standard treatment modality for OLP. Recently, photodynamic therapy (PDT) has been advocated as a new treatment modality for OLP.
AIM


The aim of the present study is to compare the effect of PDT using methylene blue (MB) as a photosensitizer to the effect of topical corticosteroids in the treatment of erosive OLP lesions.
MATERIALS AND METHODS


Our study included 20 patients with erosive OLP. Patients were divided into two groups. The study group included 10 patents which received MB-PDT. Patients were instructed to use MB as mouth path for 5 min. After 10 min, we applied focal red light on OLP lesions (wavelength 660 nm, Intensity 100-130 m W/cm2) for 2 min. The PDT was applied twice a week for four weeks. In the control group, 10 patients were instructed to apply topical betamethasone valerate ointment 100 mg on OLP lesion three times per day for four weeks. Subjective, objective scores and lesion size were recorded at time zero, after 2 weeks and after 4 weeks from the start of treatments.
RESULTS


Both groups showed statistically significant differences between time zero and the 4 th  week of treatment in subjective, objective scores and the area of the lesions. MB-PDT showed a higher degree of improvement than topical corticosteroids between time zero and the 4 th  week of treatment.
CONCLUSION


Photodynamic therapy can be used as a treatment for erosive OLP. PDT offers improvement of OLP subjective and objective scores without major side effects.",2020,"Both groups showed statistically significant differences between time zero and the 4 th  week of treatment in subjective, objective scores and the area of the lesions.",['20 patients with erosive OLP'],"['topical corticosteroids', 'photodynamic therapy (PDT', 'Photodynamic therapy', 'topical betamethasone valerate ointment', 'MB-PDT', 'PDT using methylene blue (MB']","['Subjective, objective scores and lesion size', 'OLP subjective and objective scores', 'subjective, objective scores and the area of the lesions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439679', 'cui_str': 'Erosive (qualifier value)'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0031740', 'cui_str': 'Photodynamic Therapy'}, {'cui': 'C0044588', 'cui_str': 'PDT'}, {'cui': 'C0750848', 'cui_str': 'Betamethasone valerate'}, {'cui': 'C0028912', 'cui_str': 'Salves'}, {'cui': 'C0025746', 'cui_str': 'methylthioninium chloride'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449453', 'cui_str': 'Lesion size'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]",20.0,0.0434184,"Both groups showed statistically significant differences between time zero and the 4 th  week of treatment in subjective, objective scores and the area of the lesions.","[{'ForeName': 'Wafaa', 'Initials': 'W', 'LastName': 'Saleh', 'Affiliation': 'Oral Medicine and Periodontology Department, Faculty of Dentistry, Mansoura University, 35516, Egypt. Electronic address: wafaasaid@mans.edu.eg.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Tageldin', 'Affiliation': 'College of Dentistry, Alexandria University, 21544, Egypt.'}, {'ForeName': 'Eman', 'Initials': 'E', 'LastName': 'Khashaba', 'Affiliation': 'Public Health and Community Medicine Department, College of Medicine, Mansoura University, 35516, Egypt.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Darwish', 'Affiliation': 'Oral Medicine and Periodontology Department, Faculty of Dentistry, Mansoura University, 35516, Egypt.'}, {'ForeName': 'Sherif', 'Initials': 'S', 'LastName': 'Elnagdy', 'Affiliation': 'Oral Pathology Department, Faculty of Dentistry, Mansoura University, Mansoura, 35516, Egypt.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Khashaba', 'Affiliation': 'Oral Medicine and Periodontology Department, Faculty of Dentistry, Mansoura University, 35516, Egypt.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101677']
3425,19474112,Bone fractures among postmenopausal patients with endocrine-responsive early breast cancer treated with 5 years of letrozole or tamoxifen in the BIG 1-98 trial.,"BACKGROUND


To compare the incidence and timing of bone fractures in postmenopausal women treated with 5 years of adjuvant tamoxifen or letrozole for endocrine-responsive early breast cancer in the Breast International Group (BIG) 1-98 trial.
METHODS


We evaluated 4895 patients allocated to 5 years of letrozole or tamoxifen in the BIG 1-98 trial who received at least some study medication (median follow-up 60.3 months). Bone fracture information (grade, cause, site) was collected every 6 months during trial treatment.
RESULTS


The incidence of bone fractures was higher among patients treated with letrozole [228 of 2448 women (9.3%)] versus tamoxifen [160 of 2447 women (6.5%)]. The wrist was the most common site of fracture in both treatment groups. Statistically significant risk factors for bone fractures during treatment included age, smoking history, osteoporosis at baseline, previous bone fracture, and previous hormone replacement therapy.
CONCLUSIONS


Consistent with other trials comparing aromatase inhibitors to tamoxifen, letrozole was associated with an increase in bone fractures. Benefits of superior disease control associated with letrozole and lower incidence of fracture with tamoxifen should be considered with the risk profile for individual patients.",2009,The wrist was the most common site of fracture in both treatment groups.,"['postmenopausal patients with endocrine-responsive early breast cancer treated with 5 years of', 'postmenopausal women treated with 5 years of adjuvant', '4895 patients allocated to 5 years of', 'for endocrine-responsive early breast cancer in the Breast International Group (BIG) 1-98 trial']","['tamoxifen', 'tamoxifen or letrozole', 'letrozole', 'letrozole or tamoxifen', 'tamoxifen, letrozole']","['Bone fractures', 'Bone fracture information (grade, cause, site', 'bone fractures', 'incidence of bone fractures']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}]","[{'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}]","[{'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",4895.0,0.0679758,The wrist was the most common site of fracture in both treatment groups.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rabaglio', 'Affiliation': 'IBCSG Coordinating Center and Inselspital, Bern, Switzerland. Electronic address: manuela.rabaglio@ibcsg.org.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'IBCSG Statistical Center, Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Price', 'Affiliation': 'IBCSG Statistical Center and Frontier Science and Technology Research Foundation, Boston, MA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Castiglione-Gertsch', 'Affiliation': 'IBCSG Coordinating Center, Bern.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hawle', 'Affiliation': 'IBCSG Coordinating Center, Bern.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Thürlimann', 'Affiliation': 'Senology Center of Eastern Switzerland and Swiss Group for Clinical Cancer Research (SAKK), Kantonsspital, St Gallen, Switzerland, Swiss Group for Clinical Cancer Research (SAKK).'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Mouridsen', 'Affiliation': 'Danish Breast Cancer Cooperative Group, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Campone', 'Affiliation': 'Institut du Cancer Nantes Atlantique, CLCC René Gauducheau, Saint Herblain, Fédération Nationale des Centres de Lutte Contre le Cancer, France.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Forbes', 'Affiliation': 'Australian New Zealand Breast Cancer Trials Group, University of Newcastle, Calvary Mater Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Paridaens', 'Affiliation': 'Department of Medical Oncology, University Hospital Gasthuisberg, Catholic University of Leuven, Leuven, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Colleoni', 'Affiliation': 'Research Unit in Medical Senology, Department of Medicine, European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Pienkowski', 'Affiliation': 'Cancer Center Maria Sklodowska-Curie Memorial Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'J-M', 'Initials': 'JM', 'LastName': 'Nogaret', 'Affiliation': 'Department of Mammary and Pelvic Surgery, Jules Bordet Institute; Brussels, Belgium.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Láng', 'Affiliation': 'Department of Medical Oncology, National Institute of Oncology, Budapest, Hungary.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Smith', 'Affiliation': 'Breast Unit, The Royal Marsden Hospital, London, UK.'}, {'ForeName': 'R D', 'Initials': 'RD', 'LastName': 'Gelber', 'Affiliation': 'IBCSG Statistical Center, Dana-Farber Cancer Institute, Harvard School of Public Health and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Goldhirsch', 'Affiliation': 'Department of Medicine, European Institute of Oncology, Milan, Italy; Oncology Institute of Southern Switzerland, Bellinzona, Switzerland.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Coates', 'Affiliation': 'International Breast Cancer Study Group and University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp033']
3426,32006264,Effect of CO 2  laser (10.6 μm) and Remin Pro on microhardness of enamel white spot lesions.,"This study investigated the combined effect of CO 2  laser irradiation and Remin Pro paste on microhardness of enamel white spot lesions (WSLs). Seventy-eight intact premolars were randomly assigned into six groups and then stored in a demineralizing solution to create WSLs. Afterwards, the teeth in group 6 (negative control) remained untreated, while groups 1 and 4 were exposed to CO 2  laser irradiation (20 Hz, 1 W, 30 s) and Remin Pro paste, respectively. In groups 2 and 3, the teeth were exposed to laser either before (group 2) or after (group 3) Remin Pro application. The teeth in groups 1 to 5 were then immersed in artificial saliva for 90 days while subjected to fluoride mouthwash and weekly brushing. Finally, the teeth were sectioned, and Vickers microhardness was measured at the enamel surface and at 50, 100, and 150 μm from the surface. One sample of each group was also examined with scanning electron microscope (SEM). Data were analyzed by two-way analysis of variance (ANOVA) and Tukey's test. The significance was set at 0.05. Laser irradiation followed by Remin Pro application (group 2) caused a significant increase in total WSLs' microhardness compared with laser alone (group 1) and control groups (P < 0.05). Microhardness at depths of 100 and 150 μm was also significantly greater in group 2 compared with those of group 3 and control groups (P < 0.05). Combined application of CO 2  laser with Remin Pro paste, when laser is irradiated before the paste, is suggested for re-hardening of WSLs in deep layers of enamel.",2020,Microhardness at depths of 100 and 150 μm was also significantly greater in group 2 compared with those of group 3 and control groups (P < 0.05).,['Seventy-eight intact premolars'],"['demineralizing solution to create WSLs', 'CO 2  laser irradiation and Remin Pro paste', 'Laser irradiation followed by Remin Pro application', 'CO 2  laser irradiation', 'scanning electron microscope (SEM', 'CO 2  laser with Remin Pro paste', 'CO 2  laser (10.6\xa0μm) and Remin Pro', 'fluoride mouthwash and weekly brushing']","['microhardness of enamel white spot lesions (WSLs', ""total WSLs' microhardness""]","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}]","[{'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0181845', 'cui_str': 'Electron microscope'}, {'cui': 'C0016327', 'cui_str': 'Fluorides'}, {'cui': 'C0026647', 'cui_str': 'Oral Rinse'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C0043154', 'cui_str': 'Dental White Spot'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.0130004,Microhardness at depths of 100 and 150 μm was also significantly greater in group 2 compared with those of group 3 and control groups (P < 0.05).,"[{'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Rafiei', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Pooya', 'Initials': 'P', 'LastName': 'Fadaei Tehrani', 'Affiliation': 'Dental Students Research Center, Faculty of Dentistry, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. pooya.fadaei@yahoo.com.'}, {'ForeName': 'Soghra', 'Initials': 'S', 'LastName': 'Yassaei', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Haerian', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}]",Lasers in medical science,['10.1007/s10103-020-02970-y']
3427,31539601,A Feasibility Study to Develop and Test a Cognitive Behavioral Stress Management Mobile Health Application for HIV-Related Fatigue.,"CONTEXT


Exacerbated by life stressors, fatigue is the most common symptom for people living with HIV.
OBJECTIVE


To adapt, develop, and assess the feasibility of a Cognitive Behavioral Stress Management Mobile Health (CBSM mHealth) application (app) for HIV-related fatigue.
METHODS


This study had two phases: app development with key informants (N = 5) and a randomized controlled trial (N = 30). Patients randomized to the intervention group completed 10 weekly CBSM modules; those in the control group received a generic healthy lifestyle app. Measures included HIV-related fatigue, depression, anxiety, stressful life events, CD4 count, HIV viral load, credibility and acceptability of the intervention, and barriers to treatment participation.
RESULTS


We were able to recruit participants for this study, and they were able to complete the required measures. They found the intervention to be credible and acceptable and reported few barriers to treatment participation. The direction of change in the primary outcome, a decrease in fatigue, is in the expected direction and provides evidence of the promise of the intervention, which still needs to be tested in an adequately powered trial. For completers (randomized to the intervention group and completed at least 80% of the modules), there were significant changes (95% CI; lower scores indicate improvement) in fatigue intensity (from 64.2 to 59.7) and overall fatigue-related functioning (from 6.6 to 4.2).
CONCLUSION


We have proof of concept as to the feasibility, acceptability, and initial signals of efficacy for an mHealth intervention to help people with HIV-related fatigue better cope with stress and reduce their fatigue.",2020,Patients randomized to the intervention group completed 10 weekly CBSM modules; those in the control group received a generic healthy lifestyle app.,"['HIV-related fatigue', 'people living with HIV']","['CBSM mHealth (cognitive behavioral stress management mobile health', 'generic healthy lifestyle app']","['overall fatigue-related functioning', 'fatigue intensity', 'HIV-related fatigue, depression, anxiety, stressful life events, CD4 count, HIV viral load, credibility and acceptability of the intervention, and barriers to treatment participation', 'fatigue']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0557155', 'cui_str': 'Life event observable'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.125942,Patients randomized to the intervention group completed 10 weekly CBSM modules; those in the control group received a generic healthy lifestyle app.,"[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Barroso', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, South Carolina, USA. Electronic address: barroso@musc.edu.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Madisetti', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Mueller', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, South Carolina, USA; Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2019.09.009']
3428,31992669,High-Flow Nasal Cannula May Not Reduce the Re-Intubation Rate Compared With a Large-Volume Nebulization-Based Humidifier.,"BACKGROUND


High-flow nasal cannula (HFNC) therapy may reduce the re-intubation rate compared with conventional oxygen therapy. However, HFNC has not been sufficiently compared with conventional oxygen therapy with a heated humidifier, even though heated humidification is beneficial for facilitating airway clearance.
METHODS


This study was a single-center, open-label, randomized controlled trial. We randomized subjects with respiratory failure after extubation to either HFNC group or to a large-volume humidified nebulization-based nebulizer. The primary end point was the re-intubation rate within 7 d after extubation.
RESULTS


We could not recruit enough subjects for the sample size we designed, therefore, we analyzed 69 subjects (HFNC group, 30 subjects; nebulizer group, 39 subjects). The re-intubation rate within 7 d was not significantly different between the HFNC and nebulizer groups (5/30 subjects [17%] and 6/39 subjects [15%], respectively;  P  > .99). [Formula: see text]/set [Formula: see text] at 24 h after extubation was also not significantly different between the respective groups (264 ± 105 mm Hg in the HFNC group vs 224 ± 53 mm Hg in the nebulizer group;  P  = .07).
CONCLUSIONS


Compared with a large-volume nebulization-based humidifier, HFNC may not reduce the re-intubation rate within 7 d. However, because of insufficient statistical power, further studies are needed to reach a conclusion.",2020,"The re-intubation rate within 7 d was not significantly different between the HFNC and nebulizer groups (5/30 subjects [17%] and 6/39 subjects [15%], respectively;  P  > .99).  ","['Respiratory Failure', '69 subjects (HFNC group, 30 subjects; nebulizer group, 39 subjects']","['HFNC', 'HFNC group or to a large-volume humidified nebulization-based nebulizer', 'conventional oxygen therapy', 'High-flow nasal cannula (HFNC) therapy']","['Re-Intubation Rate', 'P   aO', 're-intubation rate']","[{'cui': 'C3889105', 'cui_str': 'Respiratory failure (SMQ)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0027524', 'cui_str': 'Nebulizers'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0027524', 'cui_str': 'Nebulizers'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}]",,0.123253,"The re-intubation rate within 7 d was not significantly different between the HFNC and nebulizer groups (5/30 subjects [17%] and 6/39 subjects [15%], respectively;  P  > .99).  ","[{'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Matsuda', 'Affiliation': 'Department of Emergency Medicine and Critical Care, Center Hospital of the National Center for Global Health and Medicine, Shinjuku-ku, Tokyo, Japan. wmatsuda@hosp.ncgm.go.jp.'}, {'ForeName': 'Akiyoshi', 'Initials': 'A', 'LastName': 'Hagiwara', 'Affiliation': 'Department of Emergency Medicine, Niizashiki Chuo General Hospital, Niiza-shi, Saitama, Japan.'}, {'ForeName': 'Tatsuki', 'Initials': 'T', 'LastName': 'Uemura', 'Affiliation': 'Department of Emergency Medicine and Critical Care, Center Hospital of the National Center for Global Health and Medicine, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Takunori', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Department of Emergency Medicine and Critical Care, Center Hospital of the National Center for Global Health and Medicine, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Emergency Medicine and Critical Care, Center Hospital of the National Center for Global Health and Medicine, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Sasaki', 'Affiliation': 'Department of Emergency Medicine and Critical Care, Center Hospital of the National Center for Global Health and Medicine, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Okamoto', 'Affiliation': 'Department of Intensive Care Medicine, Center Hospital of the National Center for Global Health and Medicine, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Kimura', 'Affiliation': 'Department of Emergency Medicine and Critical Care, Center Hospital of the National Center for Global Health and Medicine, Shinjuku-ku, Tokyo, Japan.'}]",Respiratory care,['10.4187/respcare.07095']
3429,31346969,Effect of Vitamin D Supplementation in the Prevention of Recurrent Pneumonia in Under-Five Children.,"OBJECTIVE


To assess the effect of vitamin D supplementation in the prevention of recurrent pneumonia in under-five children.
METHODS


The present one year 8 months longitudinal, community-based randomized controlled study included a total of 100 under-five children with pneumonia. Children were divided into two groups: intervention group (Group I: standard treatment with vitamin D 300,000 IU; n = 50) and control group (Group C: standard treatment only; n = 50). As nine samples were hemolyzed, groups I and C comprised of 46 and 45 children, respectively. The children were followed up for 1 y and signs of upper respiratory tract infections (URTI), lower respiratory tract infections (LRTI), vitamin D deficiency, and vitamin D toxicity were recorded.
RESULTS


The male to female ratio in group C and I was 1.27:1 and 1.5:1, respectively (P = 0.420). Age, gender, birth, anthropometric and clinical characteristics, and feeding habits were not statistically significant (P > 0.05) between both the cohorts (Group C and I). Children with reduced vitamin D levels were high in group C (25) when compared to the group I (15). During all the follow-ups, the URTI and LRTI episodes, severity of pneumonia, number of hospital admissions, complications, mean episodes of LRTI, and mean duration of LRTI were comparable between group I and group C (P > 0.05).
CONCLUSIONS


Overall, the present study highlights that oral vitamin D (300,000 IU bolus dose quarterly) has some beneficial effect in the prevention of recurrent pneumonia in under-five children, although, not to a significant degree. Hence, it is recommended that further studies are required to demonstrate a significant effect of vitamin D in the prevention of pneumonia.",2019,Children with reduced vitamin D levels were high in group C (25) when compared to the group I (15).,"['Recurrent Pneumonia in Under-Five Children', 'recurrent pneumonia in under-five children', '100 under-five children with pneumonia']","['vitamin D supplementation', 'vitamin D', 'Vitamin D Supplementation', 'standard treatment with vitamin D 300,000\xa0IU; n\u2009=\u200950) and control group (Group C: standard treatment only; n\u2009=\u200950', 'oral vitamin D']","['URTI and LRTI episodes, severity of pneumonia, number of hospital admissions, complications, mean episodes of LRTI, and mean duration of LRTI', 'vitamin D levels', 'upper respiratory tract infections (URTI), lower respiratory tract infections (LRTI), vitamin D deficiency, and vitamin D toxicity']","[{'cui': 'C0694550', 'cui_str': 'Recurrent pneumonia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection (disorder)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C0242154', 'cui_str': 'Vitamin D toxicity'}]",,0.0370608,Children with reduced vitamin D levels were high in group C (25) when compared to the group I (15).,"[{'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': ""Department of Pediatrics, KAHER'S JN Medical College, Nehru Nagar, Belagavi, Karnataka, 590010, India. drnehasingh16@gmail.com.""}, {'ForeName': 'Dnyanesh', 'Initials': 'D', 'LastName': 'Kamble', 'Affiliation': ""Department of Pediatrics, KAHER'S JN Medical College, Nehru Nagar, Belagavi, Karnataka, 590010, India. drdnyaneshk@gmail.com.""}, {'ForeName': 'N S', 'Initials': 'NS', 'LastName': 'Mahantshetti', 'Affiliation': ""Department of Pediatrics, KAHER'S JN Medical College, Nehru Nagar, Belagavi, Karnataka, 590010, India.""}]",Indian journal of pediatrics,['10.1007/s12098-019-03025-z']
3430,31474281,Double jeopardy - Double remedy? The effectiveness of self-affirmation for improving doubly disadvantaged students' mathematical performance.,"This study examines the effectiveness of a self-affirmation intervention to improve academic achievement for students with a ""double-jeopardy status"" of belonging to two potentially disadvantaged groups at the same time: girls with a minority background. The method established in the U.S. is adapted to the German cultural context and evaluated for its immediate and medium-term efficacy on math achievement among girls as well as among ethnic minority youth after the transition to secondary school. We applied a double-blind pre-post experimental design with randomized treatment allocation in 11 schools (N = 820, seventh graders with various ethnic backgrounds). Following the intervention of a brief in-class writing assignment about their personal values, students performed a standardized mathematics test. A follow-up achievement test, but no intervention, was administered eight weeks later to assess the midterm effectiveness of the treatment. Between assessments students received a written feedback about their scores in the math test. The multi-level linear model results show that (1) double-jeopardy in math performance exists, as shown by independent negative effects of female gender and Turkish or Arab minority group membership; (2) Girls from all ethnic backgrounds and students with Turkish immigrant background in the intervention group performed significantly better in the mathematics test immediately after the intervention than their peers in the control group. (3) Eight weeks later, the intervention effect only persisted for students with minority ethnic backgrounds: Turkish and Arabic students in the intervention group scored significantly higher in the standardized mathematics test compared to their peers in the control group. (4) We found no support for a triple interaction effect of treatment, ethnic background, and gender. That is, girls with a Turkish or an Arabic background did not benefit more from the self-affirmation intervention than other minority or female students. Results are discussed in relation to self-affirmation theory and how such interventions can be applied in secondary school mathematics curricula.",2019,"(3) Eight weeks later, the intervention effect only persisted for students with minority ethnic backgrounds: Turkish and Arabic students in the intervention group scored significantly higher in the standardized mathematics test compared to their peers in the control group.","['girls with a Turkish or an Arabic background did not benefit more from the self-affirmation intervention than other minority or female students', 'students with a ""double-jeopardy status"" of belonging to two potentially disadvantaged groups at the same time: girls with a minority background', '11 schools (N\u202f=\u202f820, seventh graders with various ethnic backgrounds']",['self-affirmation intervention'],['standardized mathematics test'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0554967', 'cui_str': 'Turkish (NMO) (ethnic group)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205441', 'cui_str': 'Seventh (qualifier value)'}, {'cui': 'C0015031', 'cui_str': 'Ethnicity'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",,0.0181668,"(3) Eight weeks later, the intervention effect only persisted for students with minority ethnic backgrounds: Turkish and Arabic students in the intervention group scored significantly higher in the standardized mathematics test compared to their peers in the control group.","[{'ForeName': 'Mohini', 'Initials': 'M', 'LastName': 'Lokhande', 'Affiliation': 'Expert Council of German Foundations on Integration and Migration, Berlin, Germany. Electronic address: lokhande@svr-migration.de.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Müller', 'Affiliation': 'Expert Council of German Foundations on Integration and Migration, Berlin, Germany; Humboldt University Berlin, Berlin, Germany; Berlin Institute for Integration and Migration Research (BIM), Berlin, Germany.'}]",Journal of school psychology,['10.1016/j.jsp.2019.07.006']
3431,31630479,Apixaban and dalteparin in active malignancy-associated venous thromboembolism: The ADAM VTE trial.,"BACKGROUND


Low-molecular-weight heparin is the guideline-endorsed treatment for cancer-associated venous thromboembolism (VTE). While apixaban is approved for the treatment of acute VTE, limited data support its use in cancer patients.
OBJECTIVES


The primary outcome was major bleeding. Secondary outcomes included VTE recurrence and a composite of major plus clinically relevant non-major bleeding (CRNMB).
PATIENTS/METHODS


Patients with cancer-associated VTE were randomly assigned to receive either apixaban 10 mg twice daily for seven days followed by 5 mg twice daily for six months or subcutaneous dalteparin (200 IU/kg for one month followed by 150 IU/kg once daily).
RESULTS


Of 300 patients randomized, 287 were included in the primary analysis. Metastatic disease was present in 66% of subjects; 74% were receiving concurrent chemotherapy. Major bleeding occurred in 0% of 145 patients receiving apixaban, compared with 1.4% of 142 patients receiving dalteparin [P = .138; hazard ratio (HR) not estimable because of 0 bleeding event in apixaban group]. Recurrent VTE occurred in 0.7% of apixaban, compared to 6.3% of dalteparin patients [HR 0.099, 95% confidence interval [CI], 0.013-0.780, P = .0281). Major bleeding or CRNMB rates were 6% for both groups.
CONCLUSIONS


Oral apixaban was associated with low major bleeding and VTE recurrence rates for the treatment of VTE in cancer patients.",2020,"CONCLUSIONS


Oral apixaban was associated with low major bleeding and VTE recurrence rates for the treatment of VTE in cancer patients.","['Active Malignancy Associated Venous Thromboembolism', '300 patients randomized', 'cancer patients', 'Patients/Methods Patients with cancer-associated VTE']","['dalteparin', 'subcutaneous dalteparin', 'apixaban', 'Apixaban and Dalteparin']","['Metastatic disease', 'Recurrent VTE', 'Major bleeding or CRNMB rates', 'low major bleeding and VTE recurrence rates', 'Major bleeding', 'major bleeding', 'VTE recurrence and a composite of major plus clinically relevant non-major bleeding (CRNMB']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0630906', 'cui_str': 'triethoxyvinylsilane'}]","[{'cui': 'C0206461', 'cui_str': 'Dalteparin'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}]","[{'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0630906', 'cui_str': 'triethoxyvinylsilane'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]",287.0,0.287154,"CONCLUSIONS


Oral apixaban was associated with low major bleeding and VTE recurrence rates for the treatment of VTE in cancer patients.","[{'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'McBane', 'Affiliation': 'Vascular Medicine Division, Gonda Vascular Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Waldemar E', 'Initials': 'WE', 'LastName': 'Wysokinski', 'Affiliation': 'Vascular Medicine Division, Gonda Vascular Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jennifer G', 'Initials': 'JG', 'LastName': 'Le-Rademacher', 'Affiliation': 'Health Science Research Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Zemla', 'Affiliation': 'Health Science Research Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Aneel', 'Initials': 'A', 'LastName': 'Ashrani', 'Affiliation': 'Vascular Medicine Division, Gonda Vascular Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Tafur', 'Affiliation': 'NorthShore Medical Group, Evanston, Illinois.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Perepu', 'Affiliation': 'Medical Oncology, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Anderson', 'Affiliation': 'Department of Hematology, Oncology and Transplantation, University of Minnesota, Regions Hospital, St Paul, Minnesota.'}, {'ForeName': 'Krishna', 'Initials': 'K', 'LastName': 'Gundabolu', 'Affiliation': 'Department of Oncology and Hematology, University of Nebraska Medical Center, Omaha, Nebraska.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Kuzma', 'Affiliation': 'Department of Hematology and Oncology, First Health of the Carolinas, Pinehurst, North Carolina.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Perez Botero', 'Affiliation': 'Froedtert Cancer Center, Milwaukee, Wisconsin.'}, {'ForeName': 'Roberto A', 'Initials': 'RA', 'LastName': 'Leon Ferre', 'Affiliation': 'Medical Oncology Department, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Stanislav', 'Initials': 'S', 'LastName': 'Henkin', 'Affiliation': 'Department of Cardiology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.'}, {'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Lenz', 'Affiliation': 'Vascular Medicine Division, Gonda Vascular Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Damon E', 'Initials': 'DE', 'LastName': 'Houghton', 'Affiliation': 'Vascular Medicine Division, Gonda Vascular Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Vishnu', 'Affiliation': 'Department of Oncology and Hematology, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Loprinzi', 'Affiliation': 'Medical Oncology Department, Mayo Clinic, Rochester, Minnesota.'}]",Journal of thrombosis and haemostasis : JTH,['10.1111/jth.14662']
3432,31346621,Safety and Effectiveness of VYC-17.5L for Long-Term Correction of Nasolabial Folds.,"BACKGROUND


Juvéderm Vollure XC (VYC-17.5L; Allergan plc, Dublin, Ireland) belongs to a family of hyaluronic acid gels based on the Vycross technology platform.
OBJECTIVES


The authors sought to evaluate the safety and effectiveness of Vollure for correction of moderate to severe nasolabial folds (NLFs) over 18 months and after repeat treatment.
METHODS


In this prospective, randomized study, patients (N = 123) received initial/touch-up treatment with Vollure in 1 NLF and control filler in the contralateral NLF. Patients received optional repeat treatment with Vollure after month 12, 15, or 18. Assessments included investigator-rated NLF Severity Scale responder rates (≥1-point improvement vs baseline), patient-assessed Appraisal of Nasolabial Folds scale of the FACE-Q questionnaire, and patient satisfaction (11-point scale).
RESULTS


Median volume of Vollure injected was 1.7 mL for initial/touch-up treatment combined and 0.6 mL for repeat treatment. The NLF Severity Scale responder rates were 93%, 85%, and 59% at months 6, 9, and 18 after initial/touch-up treatment and increased to 94% at 1 month after repeat treatment. Mean patient-reported FACE-Q scores significantly improved from baseline at all timepoints. Most patients were very satisfied with treatment at all timepoints from day 3 (75%) through month 18 (68%) and at 1 month after repeat treatment (94%). Common injection site responses after initial/touch-up and repeat treatment were firmness, swelling, and tenderness to touch; most were mild/moderate.
CONCLUSIONS


Vollure was safe and effective for correction of moderate to severe NLFs, with results lasting 18 months in 59% of NLFs. Repeat treatment required one-third of the injection volume to achieve similar improvement in NLF severity as initial/touch-up treatment.
LEVEL OF EVIDENCE: 2


",2020,Most subjects were very satisfied with treatment at all timepoints from day 3 (75%) through month 18 (68%) and at 1 month after repeat treatment (94%).,['subjects (N=123) received'],"['initial/touch-up treatment with Vollure in 1 NLF and control filler in the contralateral NLF', 'VYC-17.5L']","['Safety and Effectiveness', 'NLFSS responder rate', 'Mean subject-reported FACE-Q scores', 'investigator-rated NLF Severity Scale (NLFSS) responder rates (≥1-point improvement vs baseline); subject-assessed Appraisal of Nasolabial Folds scale of the FACE-Q questionnaire; and subject satisfaction (11-point scale', 'NLF severity']",[],"[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0729441', 'cui_str': 'Filler (substance)'}, {'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0221328', 'cui_str': 'Nasolabial Fold'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0199834,Most subjects were very satisfied with treatment at all timepoints from day 3 (75%) through month 18 (68%) and at 1 month after repeat treatment (94%).,"[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Dayan', 'Affiliation': ''}, {'ForeName': 'Corey S', 'Initials': 'CS', 'LastName': 'Maas', 'Affiliation': ''}, {'ForeName': 'Pearl E', 'Initials': 'PE', 'LastName': 'Grimes', 'Affiliation': ''}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Beer', 'Affiliation': ''}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Monheit', 'Affiliation': ''}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Snow', 'Affiliation': ''}, {'ForeName': 'Diane K', 'Initials': 'DK', 'LastName': 'Murphy', 'Affiliation': ''}, {'ForeName': 'Vince', 'Initials': 'V', 'LastName': 'Lin', 'Affiliation': ''}]",Aesthetic surgery journal,['10.1093/asj/sjz200']
3433,31474280,Effects of a brief psychological intervention on students' sense of belonging and educational outcomes: The role of students' migration and educational background.,"Disadvantaged students who or whose parents immigrated (i.e., migration background) and first-generation students (i.e., non-academic background) have a higher risk of dropping out of school or university, earning poor grades, and facing mental health problems. This is likely in part a result of their impaired sense of belonging (e.g., feeling accepted and valued by peers and others) at educational institutions. In the current study, we tested the effectiveness of a belonging intervention that aims to reduce social disparities in sense of belonging-for the first time outside North America. Past research has demonstrated that the intervention supports disadvantaged students during the transition to middle school as well as to university. The intervention, at its core, is a brief reading-writing-exercise, which teaches that worries about belonging are common among freshmen and diminish over time. We conducted a pre-post-follow-up randomized control study with 86 freshmen (34.9% academic background, 44.2% non-academic background, 20.9% migration background). The intervention had differential effects on sense of belonging and self-reported grades after the first semester: For students without a migration background, the intervention had lasting positive effects on belonging; for students with a migration background, the positive effect diminished over time. Further, compared to students without a migration background, students with a migration background reported worse grades in the control condition and similar grades in the intervention condition. In addition, the intervention had positive-but no differential-effects on depression symptoms: students in the intervention group experienced less fluctuation and lower levels of depression symptoms than in the control group. The intervention had no significant effects on intentions to persist and emotional burden after six months. In sum, we found that the presented brief psychological intervention, adapted for the students with migration background, is effective but needs further customization to achieve positive and lasting outcomes.",2019,"In addition, the intervention had positive-but no differential-effects on depression symptoms: students in the intervention group experienced less fluctuation and lower levels of depression symptoms than in the control group.","[""students' sense of belonging and educational outcomes"", 'Disadvantaged students who or whose parents immigrated (i.e., migration background) and first-generation students (i.e., non-academic background) have a higher risk of dropping out of school or university, earning poor grades, and facing mental health problems', '86 freshmen (34.9% academic background, 44.2% non-academic background, 20.9% migration background']",['brief psychological intervention'],"['depression symptoms', 'intentions to persist and emotional burden']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0078516', 'cui_str': 'World Health Organization oral rehydration solution'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1533574', 'cui_str': 'Migration, function (observable entity)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}]",,0.0456694,"In addition, the intervention had positive-but no differential-effects on depression symptoms: students in the intervention group experienced less fluctuation and lower levels of depression symptoms than in the control group.","[{'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Marksteiner', 'Affiliation': 'University of Mannheim, Department of Educational Psychology, Germany. Electronic address: t.marksteiner@uni-mannheim.de.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Janke', 'Affiliation': 'University of Mannheim, Department of Educational Psychology, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Dickhäuser', 'Affiliation': 'University of Mannheim, Department of Educational Psychology, Germany.'}]",Journal of school psychology,['10.1016/j.jsp.2019.06.002']
3434,31973997,"Adjunctive sapropterin dihydrochloride treatment in schizophrenia: A positive proof-of-concept, rater-blind, randomized, multivitamin-controlled study.",,2020,,['schizophrenia'],['Adjunctive sapropterin dihydrochloride'],[],"[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}]","[{'cui': 'C1996349', 'cui_str': 'Sapropterin dihydrochloride'}]",[],,0.0833728,,"[{'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Clelland', 'Affiliation': ""Taub Institute for Research on Alzheimer's Disease and the Aging Brain, Columbia University Medical Center, 630 West 168th Street, New York, NY 10032, USA; Department of Pathology and Cell Biology, Columbia University Medical Center, 630 West 168th Street, New York, NY 10032, USA. Electronic address: cc2786@cumc.columbia.edu.""}, {'ForeName': 'Joshua T', 'Initials': 'JT', 'LastName': 'Kantrowitz', 'Affiliation': 'Department of Psychiatry, Columbia University Medical Center, 1051 Riverside Drive, New York, NY 10032, USA; New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY 10032, USA; Schizophrenia Research Center, The Nathan S. Kline Institute for Psychiatric Research, 140 Old Orangeburg Road, Orangeburg, NY 10962, USA.'}, {'ForeName': 'Tse', 'Initials': 'T', 'LastName': 'Choo', 'Affiliation': 'New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY 10032, USA.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Clelland', 'Affiliation': 'Clinical Research Department, The Nathan S. Kline Institute for Psychiatric Research, 140 Old Orangeburg Road, Orangeburg, NY 10962, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Lieberman', 'Affiliation': 'Department of Psychiatry, Columbia University Medical Center, 1051 Riverside Drive, New York, NY 10032, USA; New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY 10032, USA.'}]",Schizophrenia research,['10.1016/j.schres.2019.12.039']
3435,31345710,"Determinants of dihydroartemisinin-piperaquine treatment failure in Plasmodium falciparum malaria in Cambodia, Thailand, and Vietnam: a prospective clinical, pharmacological, and genetic study.","BACKGROUND


The emergence and spread of resistance in Plasmodium falciparum malaria to artemisinin combination therapies in the Greater Mekong subregion poses a major threat to malaria control and elimination. The current study is part of a multi-country, open-label, randomised clinical trial (TRACII, 2015-18) evaluating the efficacy, safety, and tolerability of triple artemisinin combination therapies. A very high rate of treatment failure after treatment with dihydroartemisinin-piperaquine was observed in Thailand, Cambodia, and Vietnam. The immediate public health importance of our findings prompted us to report the efficacy data on dihydroartemisinin-piperaquine and its determinants ahead of the results of the overall trial, which will be published later this year.
METHODS


Patients aged between 2 and 65 years presenting with uncomplicated P falciparum or mixed species malaria at seven sites in Thailand, Cambodia, and Vietnam were randomly assigned to receive dihydroartemisinin-piperaquine with or without mefloquine, as part of the TRACII trial. The primary outcome was the PCR-corrected efficacy at day 42. Next-generation sequencing was used to assess the prevalence of molecular markers associated with artemisinin resistance (kelch13 mutations, in particular Cys580Tyr) and piperaquine resistance (plasmepsin-2 and plasmepsin-3 amplifications and crt mutations). This study is registered with ClinicalTrials.gov, number NCT02453308.
FINDINGS


Between Sept 28, 2015, and Jan 18, 2018, 539 patients with acute P falciparum malaria were screened for eligibility, 292 were enrolled, and 140 received dihydroartemisinin-piperaquine. The overall Kaplan-Meier estimate of PCR-corrected efficacy of dihydroartemisinin-piperaquine at day 42 was 50·0% (95% CI 41·1-58·3). PCR-corrected efficacies for individual sites were 12·7% (2·2-33·0) in northeastern Thailand, 38·2% (15·9-60·5) in western Cambodia, 73·4% (57·0-84·3) in Ratanakiri (northeastern Cambodia), and 47·1% (33·5-59·6) in Binh Phuoc (southwestern Vietnam). Treatment failure was associated independently with plasmepsin2/3 amplification status and four mutations in the crt gene (Thr93Ser, His97Tyr, Phe145Ile, and Ile218Phe). Compared with the results of our previous TRACI trial in 2011-13, the prevalence of molecular markers of artemisinin resistance (kelch13 Cys580Tyr mutations) and piperaquine resistance (plasmepsin2/3 amplifications and crt mutations) has increased substantially in the Greater Mekong subregion in the past decade.
INTERPRETATION


Dihydroartemisinin-piperaquine is not treating malaria effectively across the eastern Greater Mekong subregion. A highly drug-resistant P falciparum co-lineage is evolving, acquiring new resistance mechanisms, and spreading. Accelerated elimination of P falciparum malaria in this region is needed urgently, to prevent further spread and avoid a potential global health emergency.
FUNDING


UK Department for International Development, Wellcome Trust, Bill & Melinda Gates Foundation, Medical Research Council, and National Institutes of Health.",2019,"Treatment failure was associated independently with plasmepsin2/3 amplification status and four mutations in the crt gene (Thr93Ser, His97Tyr, Phe145Ile, and Ile218Phe).","['Patients aged between 2 and 65 years presenting with uncomplicated P falciparum or mixed species malaria at seven sites in Thailand, Cambodia, and Vietnam', 'Between Sept 28, 2015, and Jan 18, 2018, 539 patients with acute P falciparum malaria were screened for eligibility, 292 were enrolled, and 140 received', 'Plasmodium falciparum malaria in Cambodia, Thailand, and Vietnam']","['dihydroartemisinin-piperaquine with or without mefloquine', 'dihydroartemisinin-piperaquine']","['plasmepsin2/3 amplification status and four mutations in the crt gene (Thr93Ser, His97Tyr, Phe145Ile, and Ile218Phe', 'efficacy, safety, and tolerability', 'PCR-corrected efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}, {'cui': 'C0006797', 'cui_str': 'Khmer Republic'}, {'cui': 'C0042658', 'cui_str': 'Viet Nam'}, {'cui': 'C0024535', 'cui_str': 'Plasmodium falciparum Malaria'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}]","[{'cui': 'C0058108', 'cui_str': 'quinghaosu, dihydro-'}, {'cui': 'C0071105', 'cui_str': ""Quinoline, 4,4'-(1,3-propanediyldi-4,1-piperazinediyl)bis(7-chloro-)""}, {'cui': 'C0025153', 'cui_str': 'Mefloquine'}]","[{'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}]",539.0,0.149168,"Treatment failure was associated independently with plasmepsin2/3 amplification status and four mutations in the crt gene (Thr93Ser, His97Tyr, Phe145Ile, and Ile218Phe).","[{'ForeName': 'Rob W', 'Initials': 'RW', 'LastName': 'van der Pluijm', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Mallika', 'Initials': 'M', 'LastName': 'Imwong', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Department of Molecular Tropical Medicine and Genetics, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Nguyen Hoang', 'Initials': 'NH', 'LastName': 'Chau', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nhu Thi', 'Initials': 'NT', 'LastName': 'Hoa', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nguyen Thanh', 'Initials': 'NT', 'LastName': 'Thuy-Nhien', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Ngo Viet', 'Initials': 'NV', 'LastName': 'Thanh', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Podjanee', 'Initials': 'P', 'LastName': 'Jittamala', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Department of Tropical Hygiene, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Borimas', 'Initials': 'B', 'LastName': 'Hanboonkunupakarn', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Kitipumi', 'Initials': 'K', 'LastName': 'Chutasmit', 'Affiliation': 'Phu Sing Hospital, Phu Sing, Thailand.'}, {'ForeName': 'Chalermpon', 'Initials': 'C', 'LastName': 'Saelow', 'Affiliation': 'Phu Sing Hospital, Phu Sing, Thailand.'}, {'ForeName': 'Ratchadaporn', 'Initials': 'R', 'LastName': 'Runjarern', 'Affiliation': 'Khun Han Hospital, Khun Han, Thailand.'}, {'ForeName': 'Weerayuth', 'Initials': 'W', 'LastName': 'Kaewmok', 'Affiliation': 'Khun Han Hospital, Khun Han, Thailand.'}, {'ForeName': 'Rupam', 'Initials': 'R', 'LastName': 'Tripura', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Peto', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Sovann', 'Initials': 'S', 'LastName': 'Yok', 'Affiliation': 'Pailin Provincial Health Department, Pailin, Cambodia.'}, {'ForeName': 'Seila', 'Initials': 'S', 'LastName': 'Suon', 'Affiliation': 'National Center for Parasitology, Entomology and Malaria Control, Phnom Penh, Cambodia.'}, {'ForeName': 'Sokunthea', 'Initials': 'S', 'LastName': 'Sreng', 'Affiliation': 'National Center for Parasitology, Entomology and Malaria Control, Phnom Penh, Cambodia.'}, {'ForeName': 'Sivanna', 'Initials': 'S', 'LastName': 'Mao', 'Affiliation': 'Sampov Meas Referral Hospital, Pursat, Cambodia.'}, {'ForeName': 'Savuth', 'Initials': 'S', 'LastName': 'Oun', 'Affiliation': 'Ratanakiri Referral Hospital, Ratanakiri, Cambodia.'}, {'ForeName': 'Sovannary', 'Initials': 'S', 'LastName': 'Yen', 'Affiliation': 'Ratanakiri Referral Hospital, Ratanakiri, Cambodia.'}, {'ForeName': 'Chanaki', 'Initials': 'C', 'LastName': 'Amaratunga', 'Affiliation': 'Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'Dysoley', 'Initials': 'D', 'LastName': 'Lek', 'Affiliation': 'National Center for Parasitology, Entomology and Malaria Control, Phnom Penh, Cambodia; School of Public Health, National Institute of Public Health, Phnom Penh, Cambodia.'}, {'ForeName': 'Rekol', 'Initials': 'R', 'LastName': 'Huy', 'Affiliation': 'National Center for Parasitology, Entomology and Malaria Control, Phnom Penh, Cambodia.'}, {'ForeName': 'Mehul', 'Initials': 'M', 'LastName': 'Dhorda', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom; WorldWide Antimalarial Resistance Network Asia Regional Centre, Bangkok, Thailand.'}, {'ForeName': 'Kesinee', 'Initials': 'K', 'LastName': 'Chotivanich', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Ashley', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom; Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit, Vientiane, Laos.'}, {'ForeName': 'Mavuto', 'Initials': 'M', 'LastName': 'Mukaka', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Waithira', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Phaik Yeong', 'Initials': 'PY', 'LastName': 'Cheah', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Maude', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom; Harvard T H Chan School of Public Health, Harvard University, Boston, MA, USA.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Amato', 'Affiliation': 'Wellcome Sanger Institute, Hinxton, United Kingdom.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Pearson', 'Affiliation': 'Wellcome Sanger Institute, Hinxton, United Kingdom; MRC Centre for Genomics and Global Health, Big Data Institute, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sónia', 'Initials': 'S', 'LastName': 'Gonçalves', 'Affiliation': 'Wellcome Sanger Institute, Hinxton, United Kingdom.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Jacob', 'Affiliation': 'Wellcome Sanger Institute, Hinxton, United Kingdom.'}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Hamilton', 'Affiliation': 'Wellcome Sanger Institute, Hinxton, United Kingdom.'}, {'ForeName': 'Rick M', 'Initials': 'RM', 'LastName': 'Fairhurst', 'Affiliation': 'Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Tarning', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Winterberg', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Dominic P', 'Initials': 'DP', 'LastName': 'Kwiatkowski', 'Affiliation': 'Wellcome Sanger Institute, Hinxton, United Kingdom; MRC Centre for Genomics and Global Health, Big Data Institute, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sasithon', 'Initials': 'S', 'LastName': 'Pukrittayakamee', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; The Royal Society of Thailand, Dusit, Bangkok, Thailand.'}, {'ForeName': 'Tran Tinh', 'Initials': 'TT', 'LastName': 'Hien', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom; Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nicholas Pj', 'Initials': 'NP', 'LastName': 'Day', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Olivo', 'Initials': 'O', 'LastName': 'Miotto', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom; Wellcome Sanger Institute, Hinxton, United Kingdom; MRC Centre for Genomics and Global Health, Big Data Institute, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'White', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Arjen M', 'Initials': 'AM', 'LastName': 'Dondorp', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom. Electronic address: arjen@tropmedres.ac.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30391-3']
3436,31989065,Dissecting the Contemporary Clerkship: Theory-based Educational Trial of Videos Versus Lectures in Medical Student Education.,"Background


Despite increasing use of the flipped classroom (FC) technique in undergraduate medical education, the benefit in learning outcomes over lectures is inconsistent. Best practices in preclass video design principles are rarely used, and it is unclear if videos can replace lectures in contemporary medical education.
Methods


We conducted a prospective quasi-experimental controlled educational study comparing theory-based videos to traditional lectures in a medical student curriculum. Medical students enrolled in an emergency medicine clerkship were randomly assigned to either a lecture group (LG) or a video group (VG). The slide content was identical, and the videos aligned with cognitive load theory-based multimedia design principles. Students underwent baseline (pretest), week 1 (posttest), and end-of-rotation (retention) written knowledge tests and an observed structured clinical examination (OSCE) assessment. We compared scores between both groups and surveyed student attitudes and satisfaction with respect to the two learning methods.
Results


There were 104 students who participated in OSCE assessments (49 LG, 55 VG) and 101 students who participated in knowledge tests (48 LG, 53 VG). The difference in OSCE scores was statistically significant 1.29 (95% confidence interval = 0.23 to 2.35, t(102) = 2.43, p = 0.017), but the actual score difference was small from an educational standpoint (12.61 for LG, 11.32 for VG). All three knowledge test scores for both groups were not significantly different.
Conclusions


Videos based on cognitive load theory produced similar results and could replace traditional lectures for medical students. Educators contemplating a FC approach should devote their valuable classroom time to active learning methods.",2020,"The difference in OSCE scores was statistically significant 1.29 (95% confidence interval = 0.23 to 2.35, t(102) = 2.43, p = 0.017), but the actual score difference was small from an educational standpoint (12.61 for LG, 11.32 for VG).","['104 students who participated in OSCE assessments (49 LG, 55 VG) and 101 students who participated in knowledge tests (48 LG, 53 VG', 'Medical students enrolled in an emergency medicine clerkship']","['flipped classroom (FC) technique', 'Contemporary Clerkship', 'lecture group (LG) or a video group (VG', 'theory-based videos to traditional lectures']",['OSCE scores'],"[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0013964', 'cui_str': 'Emergency Medicine'}]","[{'cui': 'C0540654', 'cui_str': 'FLICE-Inhibitory Protein'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",104.0,0.0319496,"The difference in OSCE scores was statistically significant 1.29 (95% confidence interval = 0.23 to 2.35, t(102) = 2.43, p = 0.017), but the actual score difference was small from an educational standpoint (12.61 for LG, 11.32 for VG).","[{'ForeName': 'Stella H M', 'Initials': 'SHM', 'LastName': 'Yiu', 'Affiliation': 'Department of Emergency Medicine The Ottawa Hospital University of Ottawa Ontario Canada.'}, {'ForeName': 'Alena M', 'Initials': 'AM', 'LastName': 'Spacek', 'Affiliation': 'Department of Emergency Medicine The Ottawa Hospital University of Ottawa Ontario Canada.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Pageau', 'Affiliation': 'Department of Emergency Medicine The Ottawa Hospital University of Ottawa Ontario Canada.'}, {'ForeName': 'Michael Y C', 'Initials': 'MYC', 'LastName': 'Woo', 'Affiliation': 'Department of Emergency Medicine The Ottawa Hospital University of Ottawa Ontario Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Curtis Lee', 'Affiliation': 'University of Newcastle Callaghan New South Wales Australia.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Frank', 'Affiliation': 'Royal College of Physicians and Surgeons of Canada Ottawa Ontario Canada.'}]",AEM education and training,['10.1002/aet2.10370']
3437,31348051,"Comparison of Macintosh Laryngoscopy in Bed-up-Head-Elevated Position With GlideScope Laryngoscopy: A Randomized, Controlled, Noninferiority Trial.","BACKGROUND


Approximately half of all difficult tracheal intubations (DTIs) are unanticipated; hence, proper positioning during intubation is critical to increase the likelihood of success. The bed-up-head-elevated (BUHE) intubation position has been shown to improve laryngeal view, reduce airway complications, and prolong safe apneic time during intubation. In this study, we sought to determine whether the BUHE intubation position is noninferior to Glidescope (GLSC)-assisted intubation with regard to laryngeal exposure.
METHODS


A total of 138 American Society of Anesthesiologists (ASA) I to III patients were randomly assigned into 2 groups and underwent baseline laryngoscopy in the sniffing position. Group BUHE patients (n = 69) were then intubated in the BUHE position, while group GLSC patients (n = 69) were intubated using GLSC laryngoscopy. Laryngeal exposure was measured using Percentage of Glottic Opening (POGO) score and Cormack-Lehane (CL) grading, and noninferiority will be declared if the difference in mean POGO scores between both groups do not exceed -15% at the lower limit of a 98% confidence interval (CI). Secondary outcomes measured included time required for intubation (TRI), number of intubation attempts, use of airway adjuncts, effort during laryngoscopy, and complications during intubation.
RESULTS


Mean POGO score in group BUHE was 80.14% ± 22.03%, while in group GLSC it was 86.45% ± 18.83%, with a mean difference of -6.3% (98% CI, -13.2% to 0.6%). In both groups, there was a significant improvement in mean POGO scores when compared to baseline laryngoscopy in the sniffing position (group BUHE, 25.8% ± 4.7%; group GLSC, 30.7% ± 6.8%) (P < .0001). The mean TRI was 36.23 ± 14.41 seconds in group BUHE, while group GLSC had a mean TRI of 44.33 ± 11.53 seconds (P < .0001). In patients with baseline CL 3 grading, there was no significant difference between mean POGO scores in both groups (group BUHE, 49.2% ± 19.6% versus group GLSC, 70.5% ± 29.7%; P = .054).
CONCLUSIONS


In the general population, BUHE intubation position provides a noninferior laryngeal view to GLSC intubation. The laryngeal views obtained in both approaches were superior to the laryngeal view obtained in the sniffing position. In view of the many advantages of the BUHE position for intubation, the lack of proven adverse effects, the simplicity, and the cost-effectiveness, we propose that clinicians should consider the BUHE position as the standard intubation position for the general population.",2020,"In both groups, there was a significant improvement in mean POGO scores when compared to baseline laryngoscopy in the sniffing position (group BUHE, 25.8% ± 4.7%; group GLSC, 30.7% ± 6.8%) (P < .0001).",['138 American Society of Anesthesiologists (ASA'],"['GlideScope Laryngoscopy', 'Glidescope (GLSC)-assisted intubation', 'baseline laryngoscopy in the sniffing position', 'Macintosh Laryngoscopy in Bed-up-Head-Elevated Position', 'GLSC laryngoscopy']","['mean POGO scores', 'Mean POGO score', 'time required for intubation (TRI), number of intubation attempts, use of airway adjuncts, effort during laryngoscopy, and complications during intubation', 'mean TRI', 'Percentage of Glottic Opening (POGO) score and Cormack-Lehane (CL) grading', 'safe apneic time', 'Laryngeal exposure']","[{'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}]","[{'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0018670', 'cui_str': 'Head'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0065404', 'cui_str': 'Tri (L)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0023078', 'cui_str': 'Larynx'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",138.0,0.151325,"In both groups, there was a significant improvement in mean POGO scores when compared to baseline laryngoscopy in the sniffing position (group BUHE, 25.8% ± 4.7%; group GLSC, 30.7% ± 6.8%) (P < .0001).","[{'ForeName': 'Samuel E H', 'Initials': 'SEH', 'LastName': 'Tsan', 'Affiliation': 'From the Department of Anaesthesiology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Siu M', 'Initials': 'SM', 'LastName': 'Lim', 'Affiliation': 'From the Department of Anaesthesiology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Mohd F Z', 'Initials': 'MFZ', 'LastName': 'Abidin', 'Affiliation': 'From the Department of Anaesthesiology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Shahmini', 'Initials': 'S', 'LastName': 'Ganesh', 'Affiliation': 'From the Department of Anaesthesiology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Chew Y', 'Initials': 'CY', 'LastName': 'Wang', 'Affiliation': 'From the Department of Anaesthesiology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004349']
3438,31987558,The effects of acute static and dynamic stretching on spring-mass leg stiffness.,"OBJECTIVE


This study investigated the effect of brief static and dynamic stretching on spring-mass leg stiffness in a vertical bilateral hopping task.
METHOD


38 men and 18 women were randomly assigned to either a natural (NAT; n = 27), or maximal (MAX; n = 29) hopping group. NAT bounced at their self-selected stiffness and MAX were instructed to bounce as stiffly as possible. Hopping was performed at 2.2 Hz on a force plate. After each of four treatment conditions (no stretch, 30 s stretch, multiple (4 × ) 30 s stretch, and dynamic stretch), subjects completed three × 30 s bouts (2 min rest periods) of hopping, in a counterbalanced crossover design. Stretches were performed on: gluteals, hamstrings, quadriceps and calves. Spring-mass leg stiffness was calculated as the ratio of peak vertical force to vertical displacement during ground contact.
RESULTS


The results revealed that men displayed greater leg stiffness than women (mean difference: 6.04 kN m -1 ; 95% likely range: 1.94-10.13 kN m -1 ), and that MAX produced higher stiffness values than NAT (mean difference: 10.93 kN m -1 ; 95% likely range: 6.84-15.03 kN m -1 ). Although there were no significant effects of treatment (p = 0.85) or time (p = 0.54) on leg stiffness, there was a significant treatment × time interaction (p = 0.015). Nevertheless, post hoc analyses were unable to identify where those differences were.
CONCLUSION


Relative to controls, the results of this study showed that brief static stretching or non task-specific dynamic stretching does not affect spring-mass leg stiffness during vertical bilateral hopping.",2020,"Although there were no significant effects of treatment (p = 0.85) or time (p = 0.54) on leg stiffness, there was a significant treatment × time interaction (p = 0.015).",['38 men and 18 women'],"['natural (NAT; n\u202f=\u202f27), or maximal (MAX; n\u202f=\u202f29) hopping group', 'kN', 'brief static and dynamic stretching', 'static stretching or non task-specific dynamic stretching', 'acute static and dynamic stretching']",['leg stiffness'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0067787', 'cui_str': 'TalANAc'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C4018995', 'cui_str': 'Hop'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C1720869', 'cui_str': 'Dynamic Stretching'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}]",,0.0316026,"Although there were no significant effects of treatment (p = 0.85) or time (p = 0.54) on leg stiffness, there was a significant treatment × time interaction (p = 0.015).","[{'ForeName': 'Jon E', 'Initials': 'JE', 'LastName': 'Goodwin', 'Affiliation': ""School of Sport, Health, and Applied Sciences, St Mary's University, Strawberry Hill, Twickenham, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Glaister', 'Affiliation': ""School of Sport, Health, and Applied Sciences, St Mary's University, Strawberry Hill, Twickenham, UK. Electronic address: mark.glaister@stmarys.ac.uk.""}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Lockey', 'Affiliation': ""School of Sport, Health, and Applied Sciences, St Mary's University, Strawberry Hill, Twickenham, UK.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Buxton', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.06.015']
3439,31987548,The effects of combined static and dynamic stretching of anti-gravitational muscles on body flexibility and standing balance: A preliminary study of healthy young participants.,"INTRODUCTION


Falling is a leading cause of injury-related death. Previous studies reported that an impairment of standing balance is one of the causative factors associated with falling. The combined use of static and dynamic stretching has been reported as a treatment method for improving standing balance. As one of the combined methods, stretching based on Mézières' concept, which has an efficacy on the improvement of body flexibility, has been used. However, it is not fully clear whether stretching based on Mézières' concept can improve standing balance. This study aimed to examine the effects of combined method of static and dynamic stretching of anti-gravitational muscles based on Mézières' concept on body flexibility and standing balance.
METHODS


This study employed a quasi-randomized controlled trial design. Thirteen subjects were assigned randomly to one of two groups: stretching or control. A sit and reach test (SRT), functional reach test (FRT), and total trajectory length of center of pressure (COP) during static standing were assessed at pre- and post-intervention. An independent t-test was used to compare the rate of improvement between both groups at each assessment.
RESULTS


The stretching group demonstrated a significantly larger rate of improvement in the total trajectory length of COP compared to the control group. In the SRT and FRT, the stretching group showed a trend toward improvement compared to the control group, but did not achieve statistical significance.
CONCLUSIONS


The combined use of static and dynamic stretching of anti-gravitational muscles might have the potential to improve the standing balance.",2020,"In the SRT and FRT, the stretching group showed a trend toward improvement compared to the control group, but did not achieve statistical significance.
","['Thirteen subjects', 'healthy young participants']","['stretching or control', 'static and dynamic stretching', 'static and dynamic stretching of anti-gravitational muscles', 'combined static and dynamic stretching of anti-gravitational muscles']","['body flexibility and standing balance', 'A sit and reach test (SRT), functional reach test (FRT), and total trajectory length of center of pressure (COP) during static standing', 'total trajectory length of COP']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C1720869', 'cui_str': 'Dynamic Stretching'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1998271', 'cui_str': 'Functional reach test (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}]",13.0,0.0186977,"In the SRT and FRT, the stretching group showed a trend toward improvement compared to the control group, but did not achieve statistical significance.
","[{'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Takeda', 'Affiliation': 'Department of Rehabilitation, Kawamura Hospital, Gifu, Japan.'}, {'ForeName': 'Masanobu', 'Initials': 'M', 'LastName': 'Iwai', 'Affiliation': 'Department of Rehabilitation, Kawamura Hospital, Gifu, Japan; Graduate School of Health Sciences, Fujita Health University, Toyoake, Japan.'}, {'ForeName': 'Shigeo', 'Initials': 'S', 'LastName': 'Tanabe', 'Affiliation': 'Faculty of Rehabilitation, School of Health Sciences, Fujita Health University, Toyoake, Japan. Electronic address: tanabes@fujita-hu.ac.jp.'}, {'ForeName': 'Soichiro', 'Initials': 'S', 'LastName': 'Koyama', 'Affiliation': 'Faculty of Rehabilitation, School of Health Sciences, Fujita Health University, Toyoake, Japan.'}, {'ForeName': 'Yui', 'Initials': 'Y', 'LastName': 'Hamauzu', 'Affiliation': 'Graduate School of Health Sciences, Fujita Health University, Toyoake, Japan.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Kumazawa', 'Affiliation': 'Faculty of Rehabilitation, School of Health Sciences, Fujita Health University, Toyoake, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Sakurai', 'Affiliation': 'Faculty of Rehabilitation, School of Health Sciences, Fujita Health University, Toyoake, Japan.'}, {'ForeName': 'Yoshikiyo', 'Initials': 'Y', 'LastName': 'Kanada', 'Affiliation': 'Faculty of Rehabilitation, School of Health Sciences, Fujita Health University, Toyoake, Japan.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.05.011']
3440,31987553,Program of therapeutic exercises associated with electrotherapy in patients with chronic neck pain: Protocol for a randomized controlled trial.,"Conservative treatment is the most common clinical management for the proper rehabilitation of patients with chronic neck pain, and there is a trend towards the use of therapeutic exercise. However, some uncertainty about the efficacy of therapeutic exercises remains, and it is necessary to conduct more studies with high methodological rigor, especially in regard to multimodal treatment, as in the combination of therapeutic exercises with electrotherapy. Thus, the objective of this study will be to evaluate the clinical effects of adding high- and low-frequency transcutaneous electrical nerve stimulation (TENS) in a program of specific therapeutic exercises for the treatment of patients with chronic neck pain. Sixty participants will be randomized into three groups: therapeutic exercise + placebo TENS group (n = 20), therapeutic exercise + high-frequency TENS group (n = 20), and therapeutic exercise + low-frequency TENS group (n = 20). Eight treatment sessions will be performed, and participants will be evaluated before and after the eight sessions and four weeks after the end of treatment. The Numerical Rating Pain Scale, Neck Disability Index, Pain-Related Catastrophizing Thoughts Scale, and Tampa Scale for Kinesiophobia will be used for participant evaluations. In the statistical analysis, a linear mixed model will be applied considering interaction between time and group factors. The addition of this electrotherapeutic modality to a therapeutic exercise program is expected to generate clinical improvements for patients with chronic neck pain, and if the results demonstrate benefits in the treatment group, this form of care could be used.",2020,"The Numerical Rating Pain Scale, Neck Disability Index, Pain-Related Catastrophizing Thoughts Scale, and Tampa Scale for Kinesiophobia will be used for participant evaluations.","['Sixty participants', 'patients with chronic neck pain']","['high- and low-frequency transcutaneous electrical nerve stimulation (TENS', 'therapeutic exercise\xa0+\xa0placebo TENS group (n\xa0=\xa020), therapeutic exercise\xa0+\xa0high-frequency TENS group (n\xa0=\xa020), and therapeutic exercise\xa0+\xa0low-frequency TENS group', 'therapeutic exercise program', 'electrotherapy']","['Numerical Rating Pain Scale, Neck Disability Index, Pain-Related Catastrophizing Thoughts Scale, and Tampa Scale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0014518', 'cui_str': ""Lyell's Syndrome""}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0013787', 'cui_str': 'Electrical Stimulation Therapy'}]","[{'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C0222045'}]",60.0,0.0340114,"The Numerical Rating Pain Scale, Neck Disability Index, Pain-Related Catastrophizing Thoughts Scale, and Tampa Scale for Kinesiophobia will be used for participant evaluations.","[{'ForeName': 'Paulo Henrique', 'Initials': 'PH', 'LastName': 'Martins-de-Sousa', 'Affiliation': 'Research Group in Rehabilitation, Exercise and Movement, Federal University of Maranhão, São Luís, MA, Brazil.'}, {'ForeName': 'Mariana Quixabeira', 'Initials': 'MQ', 'LastName': 'Guimarães Almeida', 'Affiliation': 'Research Group in Rehabilitation, Exercise and Movement, Federal University of Maranhão, São Luís, MA, Brazil.'}, {'ForeName': 'José Mariedson', 'Initials': 'JM', 'LastName': 'da Silva Junior', 'Affiliation': 'Research Group in Rehabilitation, Exercise and Movement, Federal University of Maranhão, São Luís, MA, Brazil.'}, {'ForeName': 'Alisson Sousa', 'Initials': 'AS', 'LastName': 'Santos', 'Affiliation': 'Research Group in Rehabilitation, Exercise and Movement, Federal University of Maranhão, São Luís, MA, Brazil.'}, {'ForeName': 'Gabriel Gardhel', 'Initials': 'GG', 'LastName': 'Costa Araújo', 'Affiliation': 'Research Group in Rehabilitation, Exercise and Movement, Federal University of Maranhão, São Luís, MA, Brazil.'}, {'ForeName': 'Flávio', 'Initials': 'F', 'LastName': 'de Oliveira Pires', 'Affiliation': 'Department of Physical Education, Federal University of Maranhão, São Luís, MA, Brazil.'}, {'ForeName': 'Cid André', 'Initials': 'CA', 'LastName': 'Fidelis-de-Paula-Gomes', 'Affiliation': 'Postgraduate Program in Rehabilitation Sciences, Nove de Julho University, São Paulo, SP, Brazil.'}, {'ForeName': 'Vânia Tie', 'Initials': 'VT', 'LastName': 'Koga Ferreira', 'Affiliation': 'Postgraduate Program in Health Sciences, Federal University of Amapá, Macapá, AP, Brazil.'}, {'ForeName': 'Almir Vieira', 'Initials': 'AV', 'LastName': 'Dibai-Filho', 'Affiliation': 'Postgraduate Program in Adult Health, Federal University of Maranhão, São Luís, MA, Brazil. Electronic address: dibaifilho@gmail.com.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.04.008']
3441,31997129,"The Relations Among Stress, Executive Functions, and Harsh Parenting in Mothers.","Stress is a common experience that can spillover into parenting, which in turn has important implications for child behavior. Parents' executive functioning (EF) may buffer the association between feelings of stress and parenting. However, using lower socioeconomic status (SES) and household chaos as indicators of stress, research has demonstrated inconsistent patterns with regard to this moderating role of EF. This study's first aim examined the moderating role of maternal EF on the associations between SES and household chaos, and harsh parenting. The second aim investigated the effects of experimentally induced stress on harsh parenting and whether maternal EF moderated these effects. A final sample of 101 mothers of 6 to 10-year-old children participated by completing measures of EF, household chaos, SES, and harsh parenting. Additionally, mothers were randomly assigned to either a stress group or a control group. Throughout the stress (or control) induction, mothers rated their harsh parenting in response to child misbehavior vignettes. Findings revealed that stronger EF reduced the association between household chaos and harsh parenting. There were no significant effects of SES or experimentally induced stress on harsh parenting, and EF was not a significant moderator for these stressors. These results highlight the buffering role of EF for more chronic stressors such as household chaos. SES and more acute stress, as manipulated by the TSST, at least in the current sample, may be less relevant.",2020,"There were no significant effects of SES or experimentally induced stress on harsh parenting, and EF was not a significant moderator for these stressors.","['in Mothers', '101 mothers of 6 to 10-year-old children participated by completing measures of EF, household chaos, SES, and harsh parenting']","['stress group or a control group', 'SES']","['harsh parenting, and EF', 'acute stress', 'Stress, Executive Functions, and Harsh Parenting']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C1194380', 'cui_str': 'Genus Chaos'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",101.0,0.0156263,"There were no significant effects of SES or experimentally induced stress on harsh parenting, and EF was not a significant moderator for these stressors.","[{'ForeName': 'Joanne L', 'Initials': 'JL', 'LastName': 'Park', 'Affiliation': 'Department of Psychology, The University of British Columbia, 2136 West Mall, Vancouver, BC, V6T 1Z4, Canada. j.park@psych.ubc.ca.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Johnston', 'Affiliation': 'Department of Psychology, The University of British Columbia, 2136 West Mall, Vancouver, BC, V6T 1Z4, Canada.'}]",Journal of abnormal child psychology,['10.1007/s10802-020-00622-x']
3442,31987561,Vojta Therapy versus transcutaneous electrical nerve stimulation for lumbosciatica syndrome: A quasi-experimental pilot study.,"BACKGROUND


Lumbosciatica is a common condition that affects patients' quality of life.
OBJECTIVE


To determine the efficacy of Vojta Therapy and transcutaneous electrical nerve stimulation (TENS) in the treatment of lumbosciatica.
METHODS


A ""pre-post"" quasi-experimental pilot study was carried out on 12 patients between 31 and 74 years of age who had been diagnosed with lumbosciatica and referred to the Physiotherapy Unit of the Quintanar de la Orden Health Center. Subjects were prescribed either TENS or Vojta, assigned alternately (6:6). All patients received one session of 30 min per day for 15 days. Tests to evaluate pain, disability, functionality, and radiculopathy were performed.
RESULTS


The differences between pre-post measures and improvement after both treatments were analyzed with nonparametric tests. Significant improvements were noted after both treatments in indices for pain, disability, and flexibility, with the exception of disability after TENS, according to the Roland-Morris test (p = 0.066). Improvements in radiculopathy (Làsegue sign) were only observed with Vojta (p = 0.031). An overall decrease in scores obtained after Vojta was observed with respect to those obtained after TENS (difference V-T): pain according to the Visual Analog Scale (V-T = 2.84; p = 0.033) or Oswestry back pain (V-T = 2.67; p = 0.030) and leg pain tests (V-T = 3.25; p = 0.063); disability according to Oswestry (V-T = 28.33; p = 0.005) and Roland-Morris (V-T = 5.67; p = 0.044); flexibility according to Schöber (average gain V-T = 0.43; p = 0.292) and the fingertips to floor distance test (V-T = 7.5; p = 0.016).
CONCLUSIONS


Vojta Therapy led to significantly greater improvements in pain, disability, flexibility, and radiculopathy than TENS. Future studies will require larger samples to confirm these findings.",2020,"pain according to the Visual Analog Scale (V-T = 2.84; p = 0.033) or Oswestry back pain (V-T = 2.67; p = 0.030) and leg pain tests (V-T = 3.25; p = 0.063); disability according to Oswestry (V-T = 28.33; p = 0.005) and Roland-Morris (V-T = 5.67; p = 0.044); flexibility according to Schöber (average gain V-T = 0.43; p = 0.292) and the fingertips to floor distance test (V-T = 7.5; p = 0.016).
","['12 patients between 31 and 74 years of age who had been diagnosed with lumbosciatica and referred to the Physiotherapy Unit of the Quintanar de la Orden Health Center', 'lumbosciatica syndrome']","['Vojta Therapy and transcutaneous electrical nerve stimulation (TENS', 'Vojta Therapy versus transcutaneous electrical nerve stimulation', 'TENS']","['pain, disability, functionality, and radiculopathy', 'fingertips to floor distance test', 'leg pain tests', 'pain', 'pain, disability, flexibility, and radiculopathy than TENS', 'Visual Analog Scale', 'pain, disability, and flexibility', 'Oswestry back pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0700594', 'cui_str': 'Radiculopathy'}, {'cui': 'C0016249', 'cui_str': 'Floors'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0014518', 'cui_str': ""Lyell's Syndrome""}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0004604', 'cui_str': 'Backache'}]",12.0,0.0208038,"pain according to the Visual Analog Scale (V-T = 2.84; p = 0.033) or Oswestry back pain (V-T = 2.67; p = 0.030) and leg pain tests (V-T = 3.25; p = 0.063); disability according to Oswestry (V-T = 28.33; p = 0.005) and Roland-Morris (V-T = 5.67; p = 0.044); flexibility according to Schöber (average gain V-T = 0.43; p = 0.292) and the fingertips to floor distance test (V-T = 7.5; p = 0.016).
","[{'ForeName': 'María Lidia', 'Initials': 'ML', 'LastName': 'Juárez-Albuixech', 'Affiliation': 'Quintanar de la Orden Health Centre, Mancha Centro Hospital, Alcázar de San, Ciudad Real, Spain. Electronic address: lijual@gmail.com.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Redondo-González', 'Affiliation': 'Preventive Medicine and Public Health Service, University Hospital of Guadalajara, C/ Donantes de sangre S/N, 19002, Guadalajara, Spain. Electronic address: oredgon@gmail.es.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Tello', 'Affiliation': 'Autónoma University, Ctra. Colmenar Km15, 28049, Madrid, Spain. Electronic address: inmaculada.tello@uam.es.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Collado-Vázquez', 'Affiliation': 'Rey Juan Carlos University, C/ Tulipán S/N, 28933, Móstoles, Madrid, Spain. Electronic address: Susana.collado@urjc.es.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Jiménez-Antona', 'Affiliation': 'Rey Juan Carlos University, C/ Tulipán S/N, 28933, Móstoles, Madrid, Spain. Electronic address: carmen.jimenez@urjc.es.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.05.015']
3443,31987562,Investigation of different application techniques for Kinesio Taping® with an accompanying exercise protocol for improvement of pain and functionality in patients with patellofemoral pain syndrome: A pilot study.,"BACKGROUND


Patellofemoral pain syndrome (PFPS), characterized by retropatellar and peripatellar pain, is a common disorder affecting young women. Treatment has included exercise-based therapy and taping techniques for rapid reduction of symptoms and pain. Although Kinesio Taping® (KT) has been studied as adjunctive therapy, evidence on its effectiveness is limited and conflicting.
OBJECTIVE


To determine the feasibility of performing a double-blind randomized controlled trial (RCT) using KT® for PFPS treatment and to determine an ideal sample size.
DESIGN


Double-blind, randomized, controlled pilot study.
METHOD


Forty-three women (aged 18-45 years) with at least a 3-month history of PFPS were randomized based on the mechanical correction techniques: using KT® for patellar medialization (KT-PM), using KT® for lateral rotation of the femur and tibia (KT-LRFT), and the control group (CG). All groups underwent the same muscle strengthening and motor control procedures for 12 weeks. Knee pain and function were evaluated at baseline, at 6 weeks, at treatment completion (12 weeks), and during the 12-week follow-up using the numerical pain rating scale (NPRS) at rest and during effort, Anterior Knee Pain Scale (AKPS), and single jump hop test.
RESULTS


There were clinically significant differences between the KT-LRFT and the CG in terms of AKPS and NPRS scores during effort at the 6-week and 12-week follow-ups. All groups (within group) showed a significant improvement in pain and function.
CONCLUSIONS


A complete RCT using KT® for the treatment of PFPS is feasible with some changes regarding outcome measures and treatment protocols.",2020,There were clinically significant differences between the KT-LRFT and the CG in terms of AKPS and NPRS scores during effort at the 6-week and 12-week follow-ups.,"['young women', 'patients with patellofemoral pain syndrome', 'Patellofemoral pain syndrome (PFPS', 'Forty-three women (aged 18-45 years) with at least a 3-month history of PFPS']","['exercise-based therapy and taping techniques', 'Kinesio Taping® with an accompanying exercise protocol', 'KT®', 'Kinesio Taping® (KT', 'mechanical correction techniques: using KT® for patellar medialization (KT-PM), using KT® for lateral rotation of the femur and tibia (KT-LRFT']","['Knee pain and function', 'AKPS and NPRS scores', 'pain and function', 'numerical pain rating scale (NPRS) at rest and during effort, Anterior Knee Pain Scale (AKPS', 'pain and functionality']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877149', 'cui_str': 'Patellofemoral Pain Syndrome'}, {'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0231462', 'cui_str': 'Lateral rotation - action (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0040184', 'cui_str': 'Tibia'}]","[{'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0222045'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0409326', 'cui_str': 'Anterior knee pain (finding)'}]",43.0,0.0729503,There were clinically significant differences between the KT-LRFT and the CG in terms of AKPS and NPRS scores during effort at the 6-week and 12-week follow-ups.,"[{'ForeName': 'Lucas Simões', 'Initials': 'LS', 'LastName': 'Arrebola', 'Affiliation': 'Federal University of São Paulo (UNIFESP), Human Movement Sciences Department, Campus Baixada Santista, Santos, São Paulo, Brazil; State Public Servant Institute of São Paulo (IAMSPE), Physical Therapy Department, São Paulo, São Paulo, Brazil. Electronic address: lucasarrebola@gmail.com.'}, {'ForeName': 'Rogério', 'Initials': 'R', 'LastName': 'Teixeira de Carvalho', 'Affiliation': 'State Public Servant Institute of São Paulo (IAMSPE), Orthopaedics and Trauma Department, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Paloma Yan', 'Initials': 'PY', 'LastName': 'Lam Wun', 'Affiliation': 'State Public Servant Institute of São Paulo (IAMSPE), Physical Therapy Department, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Rizzi de Oliveira', 'Affiliation': 'Federal University of São Paulo (UNIFESP), Human Movement Sciences Department, Campus Baixada Santista, Santos, São Paulo, Brazil; State Public Servant Institute of São Paulo (IAMSPE), Physical Therapy Department, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Firmo Dos Santos', 'Affiliation': 'State Public Servant Institute of São Paulo (IAMSPE), Physical Therapy Department, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Vanessa Gonçalves', 'Initials': 'VG', 'LastName': 'Coutinho de Oliveira', 'Affiliation': 'Federal University of São Paulo (UNIFESP), Human Movement Sciences Department, Campus Baixada Santista, Santos, São Paulo, Brazil; State Public Servant Institute of São Paulo (IAMSPE), Physical Therapy Department, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Carlos Eduardo', 'Initials': 'CE', 'LastName': 'Pinfildi', 'Affiliation': 'Federal University of São Paulo (UNIFESP), Human Movement Sciences Department, Campus Baixada Santista, Santos, São Paulo, Brazil.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.05.022']
3444,31987565,Continuous shortwave diathermy with exercise reduces pain and improves function in Lateral Epicondylitis more than sham diathermy: A randomized controlled trial.,"INTRODUCTION


Lateral epicondylitis or tennis elbow, causes significant pain and disability in the upper extremity. Conservative approaches include using thermal and electrical agents. The aim of this study was to explore the effectiveness of shortwave diathermy on pain, function and grip strength of patients with chronic lateral epicondylitis. A randomized placebo-controlled design with concealed allocation, assessor blinding and intention-to-treat analysis was conducted.
METHODS


Fifty patients suffering from lateral epicondylitis for more than 3 months, without any systemic diseases or history of other pathologies, were divided into two groups. In both groups, the patients were instructed to perform specific stretching and strengthening exercises. In addition, the patients in the experimental group, received 15 min of 40-60 W, continuous short wave diathermy while sham diathermy was applied for the control group. The primary outcome measure was pain and the secondary outcome measures were functional ability and pain free grip strength. Outcomes were assessed at the base line, after the 5th and the 10th session of treatment as well as after 3 months.
RESULTS


Mixed ANOVA analysis showed significant improvement in both groups. Meanwhile, there was a significant interaction effect of time and group on all outcome measures implying the greater improvement in pain, function and grip strength in the group receiving real diathermy.
CONCLUSIONS


Adding continuous short wave diathermy to a specific regimen of exercises, reduces pain and improves function in patients suffering from chronic lateral epicondylitis more than sham diathermy and exercise.
TRIAL REGISTRATION


IRCT2016042321139N4.",2020,"RESULTS


Mixed ANOVA analysis showed significant improvement in both groups.","['Fifty patients suffering from lateral epicondylitis for more than 3 months, without any systemic diseases or history of other pathologies', 'patients suffering from chronic lateral epicondylitis more than sham diathermy and exercise', 'patients with chronic lateral epicondylitis']","['shortwave diathermy', '15\u202fmin of 40-60\u202fW, continuous short wave diathermy while sham diathermy', 'specific stretching and strengthening exercises', 'sham diathermy', 'placebo', 'Continuous shortwave diathermy with exercise']","['pain', 'pain, function and grip strength', 'functional ability and pain free grip strength', 'pain and improves function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039516', 'cui_str': 'Lateral Epicondylitis'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0442893', 'cui_str': 'Systemic illness (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0012002', 'cui_str': 'Diathermy'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0012002', 'cui_str': 'Diathermy'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0204027', 'cui_str': 'Short wave diathermy (procedure)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise (regime/therapy)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",50.0,0.196015,"RESULTS


Mixed ANOVA analysis showed significant improvement in both groups.","[{'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Babaei-Ghazani', 'Affiliation': 'Neuromusculoskeletal Research Center, Iran University of Medical Sciences, Tehran, Iran; Department of Physical Medicine and Rehabilitation, School of Medicine, Iran University of Medical Sciences, Tehran, Iran. Electronic address: arashbabaie@gmail.com.'}, {'ForeName': 'Banafsheh', 'Initials': 'B', 'LastName': 'Shahrami', 'Affiliation': 'Neuromusculoskeletal Research Center, Iran University of Medical Sciences, Tehran, Iran; Department of Physical Medicine and Rehabilitation, School of Medicine, Iran University of Medical Sciences, Tehran, Iran. Electronic address: banafsheh.shahrami@gmail.com.'}, {'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Fallah', 'Affiliation': 'Department of Orthopedics, School of Medicine, AJA University of Medical Sciences, Tehran, Iran. Electronic address: dr.ehsan.fallah@gmail.com.'}, {'ForeName': 'Tannaz', 'Initials': 'T', 'LastName': 'Ahadi', 'Affiliation': 'Neuromusculoskeletal Research Center, Iran University of Medical Sciences, Tehran, Iran; Department of Physical Medicine and Rehabilitation, School of Medicine, Iran University of Medical Sciences, Tehran, Iran. Electronic address: tannaz.ahadi@yahoo.com.'}, {'ForeName': 'Bijan', 'Initials': 'B', 'LastName': 'Forough', 'Affiliation': 'Neuromusculoskeletal Research Center, Iran University of Medical Sciences, Tehran, Iran; Department of Physical Medicine and Rehabilitation, School of Medicine, Iran University of Medical Sciences, Tehran, Iran. Electronic address: bijanfr@gmail.com.'}, {'ForeName': 'Safoora', 'Initials': 'S', 'LastName': 'Ebadi', 'Affiliation': 'Neuromusculoskeletal Research Center, Iran University of Medical Sciences, Tehran, Iran; Department of Physical Medicine and Rehabilitation, School of Medicine, Iran University of Medical Sciences, Tehran, Iran. Electronic address: ebadi.s@iums.ac.ir.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.05.025']
3445,31987569,Effects of glycerin oil and lavender oil massages on hemodialysis patients' restless legs syndrome.,"OBJECTIVES


To determine the effects of glycerin oil and lavender oil massages on hemodialysis patients' restless legs syndrome (RLS).
METHODS


Ninety hemodialysis patients with RLS were randomly allocated into two intervention groups and one control group, each consisting of 35 participants. The control group received routine care, and the intervention groups received effleurage massage with lavender and glycerin oil in addition to routine care for one month. RLS intensity was measured among the three groups using the Restless Legs Syndrome Rating Scale.
RESULTS


At the beginning of the study, the results showed no significant difference among the three groups' scores. At the end of the study, the mean RLS scores were significantly lower in the intervention groups compared to the control group (F = 63.4, p ≤ 0.001). This difference was not significant between the two intervention groups; nonetheless, the differences between the control and lavender oil groups, as well as the control and glycerin oil groups, were significant (p < 0.05).
CONCLUSION


The findings showed the effectiveness of the oils through the effleurage massage for reducing RLS in a sample of hemodialysis patients.",2020,"At the end of the study, the mean RLS scores were significantly lower in the intervention groups compared to the control group (F = 63.4, p ≤ 0.001).","['Ninety hemodialysis patients with RLS', ""hemodialysis patients' restless legs syndrome"", ""hemodialysis patients' restless legs syndrome (RLS""]","['glycerin oil and lavender oil massages', 'routine care, and the intervention groups received effleurage massage with lavender and glycerin oil']","['mean RLS scores', 'Restless Legs Syndrome Rating Scale', 'RLS intensity']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035258', 'cui_str': 'Wittmaack Ekbom Syndrome'}]","[{'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0064694', 'cui_str': 'lavender oil'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0203907', 'cui_str': 'Effleurage (regime/therapy)'}, {'cui': 'C0524903', 'cui_str': 'Lavender'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3887611', 'cui_str': 'Restlessness (finding)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0222045'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",90.0,0.0145496,"At the end of the study, the mean RLS scores were significantly lower in the intervention groups compared to the control group (F = 63.4, p ≤ 0.001).","[{'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Mirbagher Ajorpaz', 'Affiliation': 'Autoimmune Diseases Research Center, Department of Nursing and Midwifery, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Rahemi', 'Affiliation': 'Clemson University School of Nursing, SC, USA.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Aghajani', 'Affiliation': 'Infectious Diseases Research Center, Kashan University of Medical Sciences, Kashan, Iran. Electronic address: Aghajani_m@kaums.ac.ir.'}, {'ForeName': 'Sayyed Hossein', 'Initials': 'SH', 'LastName': 'Hashemi', 'Affiliation': 'Kashan University of Medical Sciences, Trauma Nursing Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.06.012']
3446,31988257,' Immunising' physicians against availability bias in diagnostic reasoning: a randomised controlled experiment.,"BACKGROUND


Diagnostic errors have often been attributed to biases in physicians' reasoning. Interventions to 'immunise' physicians against bias have focused on improving reasoning processes and have largely failed.
OBJECTIVE


To investigate the effect of increasing physicians' relevant knowledge on their susceptibility to availability bias.
DESIGN, SETTINGS AND PARTICIPANTS


Three-phase multicentre randomised experiment with second-year internal medicine residents from eight teaching hospitals in Brazil.
INTERVENTIONS


Immunisation: Physicians diagnosed one of two sets of vignettes (either diseases associated with chronic diarrhoea or with jaundice) and compared/contrasted alternative diagnoses with feedback. Biasing phase (1 week later): Physicians were biased towards either inflammatory bowel disease or viral hepatitis. Diagnostic performance test: All physicians diagnosed three vignettes resembling inflammatory bowel disease, three resembling hepatitis (however, all with different diagnoses). Physicians who increased their knowledge of either chronic diarrhoea or jaundice 1 week earlier were expected to resist the bias attempt.
MAIN OUTCOME MEASUREMENTS


Diagnostic accuracy, measured by test score (range 0-1), computed for subjected-to-bias and not-subjected-to-bias vignettes diagnosed by immunised and not-immunised physicians.
RESULTS


Ninety-one residents participated in the experiment. Diagnostic accuracy differed on subjected-to-bias vignettes, with immunised physicians performing better than non-immunised physicians (0.40 vs 0.24; difference in accuracy 0.16 (95% CI 0.05 to 0.27); p=0.004), but not on not-subjected-to-bias vignettes (0.36 vs 0.41; difference -0.05 (95% CI -0.17 to 0.08); p=0.45). Bias only hampered non-immunised physicians, who performed worse on subjected-to-bias than not-subjected-to-bias vignettes (difference -0.17 (95% CI -0.28 to -0.05); p=0.005); immunised physicians' accuracy did not differ (p=0.56).
CONCLUSIONS


An intervention directed at increasing knowledge of clinical findings that discriminate between similar-looking diseases decreased physicians' susceptibility to availability bias, reducing diagnostic errors, in a simulated setting. Future research needs to examine the degree to which the intervention benefits other disease clusters and performance in clinical practice.
TRIAL REGISTRATION NUMBER


68745917.1.1001.0068.",2020,"Diagnostic accuracy differed on subjected-to-bias vignettes, with immunised physicians performing better than non-immunised physicians (0.40 vs 0.24; difference in accuracy 0.16 (95% CI 0.05 to 0.27); p=0.004), but not on not-subjected-to-bias vignettes (0.36 vs 0.41; difference -0.05 (95% CI -0.17 to 0.08); p=0.45).","['Ninety-one residents participated in the experiment', 'Three-phase multicentre randomised experiment with second-year internal medicine residents from eight teaching hospitals in Brazil']",[],"['Diagnostic accuracy', 'inflammatory bowel disease or viral hepatitis', 'Diagnostic performance test', 'knowledge of either chronic diarrhoea or jaundice', 'chronic diarrhoea or with jaundice']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]",[],"[{'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C0042721', 'cui_str': 'Viral hepatitis (disorder)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0401151', 'cui_str': 'Chronic diarrhea (disorder)'}, {'cui': 'C0022346', 'cui_str': 'Icterus'}]",91.0,0.0645214,"Diagnostic accuracy differed on subjected-to-bias vignettes, with immunised physicians performing better than non-immunised physicians (0.40 vs 0.24; difference in accuracy 0.16 (95% CI 0.05 to 0.27); p=0.004), but not on not-subjected-to-bias vignettes (0.36 vs 0.41; difference -0.05 (95% CI -0.17 to 0.08); p=0.45).","[{'ForeName': 'Sílvia', 'Initials': 'S', 'LastName': 'Mamede', 'Affiliation': 'Institute of Medical Education Research Rotterdam, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands s.mamede@erasmusmc.nl.'}, {'ForeName': 'Marco Antonio', 'Initials': 'MA', 'LastName': 'de Carvalho-Filho', 'Affiliation': 'Internal Medicine, State University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Rosa Malena Delbone', 'Initials': 'RMD', 'LastName': 'de Faria', 'Affiliation': 'Propeudeutics, Federal University of Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Franci', 'Affiliation': 'Internal Medicine, State University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Maria do Patrocinio Tenorio', 'Initials': 'MDPT', 'LastName': 'Nunes', 'Affiliation': 'Internal Medicine, Universidade de São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Ligia Maria Cayres', 'Initials': 'LMC', 'LastName': 'Ribeiro', 'Affiliation': 'Department of Medical Education Development, UNIFENAS Medical School, Belo Horizonte, Brazil.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Biegelmeyer', 'Affiliation': 'Internal Medicine, Universidade de São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Zwaan', 'Affiliation': 'Institute of Medical Education Research Rotterdam, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Henk G', 'Initials': 'HG', 'LastName': 'Schmidt', 'Affiliation': 'Institute of Medical Education Research Rotterdam, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}]",BMJ quality & safety,['10.1136/bmjqs-2019-010079']
3447,31986899,Development and Evaluation of a Cancer Literacy Intervention to Promote Mammography Screening Among Navajo Women: A Pilot Study.,"PURPOSE


Develop and evaluate a mammography intervention that provides hope about cancer prevention and treatment.
DESIGN


Pilot randomized controlled trial.
SETTING


Two communities on the Navajo Nation.
PARTICIPANTS


Navajo women and support persons.
INTERVENTION


Both groups received standard care: one home visit discussing mammography pros/cons and barriers. The treatment group received an intervention based on Navajo language via an additional home visit with health education materials (written and oral) in English and Navajo, including a Navajo Cancer Glossary with a new descriptive phrase for cancer.
ANALYSIS


Between control and intervention conditions, we compared baseline sociodemographics; changes from baseline to 3 months on mammography completion and breast cancer literacy scores.
MEASURES


(1) intervention feasibility; (2) self- and clinic-reported mammography screening completion; (3) breast cancer literacy.
RESULTS


A total of 25 participants were randomly assigned (13 treatment, 12 control), with 7 support persons in each arm. Mean age was 53 years, 90% had a high school degree or higher, 86% spoke Navajo and English. At 3 months, 44% had a clinically verified mammogram. Mammography completion was 57% among those with a support person and 27% among those without ( P  = .14). Intervention women reported more breast cancer beliefs consistent with mammography ( P  = .015).
CONCLUSIONS


Increases in breast cancer beliefs consistent with mammography show promise. Findings highlight a need to tailor education materials to Navajo culture/language and focus on enhancing support.",2020,Mammography completion was 57% among those with a support person and 27% among those without ( P  = .14).,"['Two communities on the Navajo Nation', 'A total of 25 participants', 'Mean age was 53 years, 90% had a high school degree or higher, 86% spoke Navajo and English', 'Navajo Women', 'Navajo women and support persons']","['standard care: one home visit discussing mammography pros/cons and barriers', 'intervention based on Navajo language via an additional home visit with health education materials (written and oral) in English and Navajo, including a Navajo Cancer Glossary with a new descriptive phrase for cancer', 'Cancer Literacy Intervention', 'mammography intervention']","['1) intervention feasibility; (2) self- and clinic-reported mammography screening completion; (3) breast cancer literacy', 'Mammography completion', 'mammography completion and breast cancer literacy scores', 'breast cancer beliefs']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0574545', 'cui_str': 'Navajo language (qualifier value)'}, {'cui': 'C0018701'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0681470', 'cui_str': 'Glossary'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0600665', 'cui_str': 'Phrase'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",25.0,0.040073,Mammography completion was 57% among those with a support person and 27% among those without ( P  = .14).,"[{'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Sinicrope', 'Affiliation': 'Department of Psychiatry and Psychology and Behavioral Health Research Program, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Bauer', 'Affiliation': 'Diné College, Tsaile, AZ, USA.'}, {'ForeName': 'Christi A', 'Initials': 'CA', 'LastName': 'Patten', 'Affiliation': 'Department of Psychiatry and Psychology and Behavioral Health Research Program, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Austin-Garrison', 'Affiliation': 'Diné College, Tsaile, AZ, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Garcia', 'Affiliation': 'Diné College, Tsaile, AZ, USA.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Hughes', 'Affiliation': 'Department of Psychiatry and Psychology and Behavioral Health Research Program, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Martha J', 'Initials': 'MJ', 'LastName': 'Bock', 'Affiliation': 'Department of Psychiatry and Psychology and Behavioral Health Research Program, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Decker', 'Affiliation': 'Department of Health Sciences Research, Biomedical Statistics and Behavioral Health Research Program, Rochester, MN, USA.'}, {'ForeName': 'Kathleen J', 'Initials': 'KJ', 'LastName': 'Yost', 'Affiliation': 'Department of Health Sciences Research, Survey Research Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Wesley O', 'Initials': 'WO', 'LastName': 'Petersen', 'Affiliation': 'Department of Psychiatry and Psychology and Behavioral Health Research Program, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Lydia P', 'Initials': 'LP', 'LastName': 'Buki', 'Affiliation': 'Department of Educational and Psychological Studies, University of Miami, Coral Gables, FL, USA.'}, {'ForeName': 'Edward R', 'Initials': 'ER', 'LastName': 'Garrison', 'Affiliation': 'Diné College, Tsaile, AZ, USA.'}]",American journal of health promotion : AJHP,['10.1177/0890117119900592']
3448,31987567,Acupuncture can be beneficial for exercise-induced muscle soreness: A randomised controlled trial.,"INTRODUCTION


Strenuous physical exercise may cause acute muscle soreness (AMS), which occurs directly after exercise, as well as delayed onset muscle soreness (DOMS), which occurs about 24 h after exercise. Studies of acupuncture's effect on DOMS have had contradictory results, whereas its effect on AMS has not been extensively studied. The main goal of this study was to evaluate acupuncture's effects on AMS and DOMS and on the prevention of DOMS.
METHOD


45 volunteers were randomised into a verum acupuncture group, a sham acupuncture group and a control group. After exercise-induced muscle damage was elicited, muscle soreness and pressure pain threshold were assessed at different time points. The outcome assessments were performed before (T1) and 20 min after the first acupuncture treatment (T2); then, 24 h later, they were performed before (T3) and 20 min after the second acupuncture treatment (T4). In the verum and sham acupuncture groups, acupuncture was performed for 2 min, immediately after T1 and T3 assessments, whereas subjects in the control group simply rested for 2 min without treatment. Verum acupuncture was given at ST34, ST36 and LR3, whereas sham acupuncture was given at three nontraditional points.
RESULTS


We found that verum acupuncture can reduce the occurrence of AMS by one-half and DOMS by one-third. We also found specific and nonspecific acupuncture effects in AMS and DOMS.
CONCLUSION


The uneven induction of muscle damage identified by our study, as shown by heterogeneity in pressure pain threshold values, may have led to the contradictory results in published studies on DOMS.",2020,"In the verum and sham acupuncture groups, acupuncture was performed for 2 min, immediately after T1 and T3 assessments, whereas subjects in the control group simply rested for 2 min without treatment.",['45 volunteers'],"['verum acupuncture', 'Strenuous physical exercise', 'acupuncture', 'sham acupuncture', 'Acupuncture', 'Verum acupuncture was given at ST34, ST36 and LR3, whereas sham acupuncture']","['occurrence of AMS', 'muscle soreness and pressure pain threshold']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0450531', 'cui_str': 'ST34 (body structure)'}, {'cui': 'C0450533', 'cui_str': 'ST36 (body structure)'}, {'cui': 'C0450768', 'cui_str': 'LR3 (body structure)'}]","[{'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}]",45.0,0.110874,"In the verum and sham acupuncture groups, acupuncture was performed for 2 min, immediately after T1 and T3 assessments, whereas subjects in the control group simply rested for 2 min without treatment.","[{'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Cardoso', 'Affiliation': 'Institute of Biomedical Sciences Abel Salazar, University of Porto, Rua de Jorge Viterbo Ferreira No. 228, 4050-313, Porto, Portugal; Transdisciplinary Center of Consciousness Studies of Fernando Pessoa University, Porto, Portugal; Faculty of Health Sciences, Fernando Pessoa University, Rua Carlos da Maia, 296 4200-150, Porto, Portugal. Electronic address: rcardoso@ufp.edu.pt.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Lumini-Oliveira', 'Affiliation': 'Faculty of Health Sciences, Fernando Pessoa University, Rua Carlos da Maia, 296 4200-150, Porto, Portugal; Research Centre in Physical Activity, Health and Leisure (CIAFEL), University of Porto, Rua Dr. Plácido Costa 91, 4200-450, Porto, Portugal.'}, {'ForeName': 'Maria João', 'Initials': 'MJ', 'LastName': 'Santos', 'Affiliation': 'Institute of Biomedical Sciences Abel Salazar, University of Porto, Rua de Jorge Viterbo Ferreira No. 228, 4050-313, Porto, Portugal; Heidelberg School of Chinese Medicine, Karlsruher Strasse 12, 69126, Heidelberg, Germany.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Ramos', 'Affiliation': 'Institute of Biomedical Sciences Abel Salazar, University of Porto, Rua de Jorge Viterbo Ferreira No. 228, 4050-313, Porto, Portugal.'}, {'ForeName': 'Luís Carlos', 'Initials': 'LC', 'LastName': 'Matos', 'Affiliation': 'Faculdade de Engenharia da Universidade do Porto, Rua Dr. Roberto Frias, s/n 4200-465, Porto, Portugal.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Machado', 'Affiliation': 'Institute of Biomedical Sciences Abel Salazar, University of Porto, Rua de Jorge Viterbo Ferreira No. 228, 4050-313, Porto, Portugal; Porto Biomechanics Laboratory (LABIOMEP), University of Porto, Rua Dr. Plácido Costa 91, 4200-450, Porto, Portugal.'}, {'ForeName': 'Henry Johannes', 'Initials': 'HJ', 'LastName': 'Greten', 'Affiliation': 'Institute of Biomedical Sciences Abel Salazar, University of Porto, Rua de Jorge Viterbo Ferreira No. 228, 4050-313, Porto, Portugal; Heidelberg School of Chinese Medicine, Karlsruher Strasse 12, 69126, Heidelberg, Germany.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Franconi', 'Affiliation': 'Institute of Biomedical Sciences Abel Salazar, University of Porto, Rua de Jorge Viterbo Ferreira No. 228, 4050-313, Porto, Portugal; Department of Systems Medicine, Tor Vergata University, Via Montpellier 1, 00133, Rome, Italy.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.03.015']
3449,31987545,Effects of training with a custom-made visual feedback device on balance and functional lower-extremity strength in older adults: A randomized controlled trial.,"INTRODUCTION


Training with a slow and sustained mechanical load, such as standing on one leg, is an effective method for improving balance and increasing lower-extremity strength. Also, visual feedback during motor learning is important in facilitating efficient postural responses and balance skills. In this study, a custom-made visual feedback device was invented to provide the training modality and program based on single-leg standing combined with augmented visual feedback training. This study aimed to investigate the effects of visual feedback training using the custom-made visual feedback device on balance and functional lower-extremity strength in older adults.
METHODS


Thirty-four independent older adults were randomly allocated to a training group (TG) and a control group (CG). The participants in the TG received training with the custom-made visual feedback device. The training duration was three sessions per week, for four weeks. The participants in the CG continued their routine activities. Balance (static and dynamic balances, and balance confidence) and functional lower-extremity strength were assessed pre- and post-training.
RESULTS


Improvements in static balance (sway velocity and limit of balance during one-leg standing with eyes open) and dynamic balance (directional control of limits of stability in the backward direction) were found after training in the TG compared with the CG. No significant differences in balance confidence or functional lower-extremity strength were found between groups after training.
CONCLUSION


In older adults, training with a custom-made visual feedback device could be used to improve both static and dynamic balances, but not balance confidence and functional lower-extremity strength.",2020,"No significant differences in balance confidence or functional lower-extremity strength were found between groups after training.
","['Thirty-four independent older adults', 'older adults']","['training modality and program based on single-leg standing combined with augmented visual feedback training', 'training with the custom-made visual feedback device', 'training group (TG) and a control group (CG', 'custom-made visual feedback device', 'training with a custom-made visual feedback device', 'visual feedback training']","['Balance (static and dynamic balances, and balance confidence) and functional lower-extremity strength', 'balance confidence or functional lower-extremity strength', 'static balance (sway velocity and limit of balance', 'balance and functional lower-extremity strength']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}]",,0.0157901,"No significant differences in balance confidence or functional lower-extremity strength were found between groups after training.
","[{'ForeName': 'Tanyarut', 'Initials': 'T', 'LastName': 'Oungphalachai', 'Affiliation': 'Human Movement Performance Enhancement Research Unit, Department of Physical Therapy, Faculty of Allied Health Sciences, Chulalongkorn University, Thailand.'}, {'ForeName': 'Akkradate', 'Initials': 'A', 'LastName': 'Siriphorn', 'Affiliation': 'Human Movement Performance Enhancement Research Unit, Department of Physical Therapy, Faculty of Allied Health Sciences, Chulalongkorn University, Thailand. Electronic address: akkradate.s@chula.ac.th.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.03.018']
3450,31987546,Moderate volume of sprint bouts does not induce muscle damage in well-trained athletes.,"INTRODUCTION


Understanding the recovery in response to different sprint protocols is important for optimizing neuromuscular gains and organizing training sessions in sports. The current study aimed to investigate acute neuromuscular changes following a moderate volume of sprint protocols with and without change-of-direction.
METHODS


26 well-trained male collegiate athletes from different sports were randomly allocated into straight-line group (SLG) or change-of-direction group (CODG). The protocols were 1 × 15 repetitions of 20-meter sprints in line (SLG) or with two changes in each repetition (CODG). Knee extension maximal and explosive strength, jump performance, serum creatine kinase, and quadriceps and hamstrings echo intensity were collected pre-, post- 0, 24, 48, and 72 h post-exercise.
RESULTS


There were no significant changes in any of the variables at any time point after the exercise protocols in comparison with pre-exercise values (p > 0.05).
CONCLUSIONS


The present study suggests that sprint training with moderate volume with or without change of direction does not induce neuromuscular or physiological changes during 72 h post-exercise. This information is especially important for sports staff in order to optimize training prescription and frequency.",2020,"There were no significant changes in any of the variables at any time point after the exercise protocols in comparison with pre-exercise values (p > 0.05).
",['26 well-trained male collegiate athletes from different sports'],"['straight-line group (SLG) or change-of-direction group (CODG', 'sprint training']","['Knee extension maximal and explosive strength, jump performance, serum creatine kinase, and quadriceps and hamstrings echo intensity']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0038039', 'cui_str': 'Sports'}]","[{'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439755', 'cui_str': 'Directions (qualifier value)'}, {'cui': 'C0454374', 'cui_str': 'Sprint training (regime/therapy)'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C1721090', 'cui_str': 'Explosives'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0858112', 'cui_str': 'Serum creatine'}, {'cui': 'C4521566', 'cui_str': 'Kinase'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",,0.0276729,"There were no significant changes in any of the variables at any time point after the exercise protocols in comparison with pre-exercise values (p > 0.05).
","[{'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Grazioli', 'Affiliation': 'Exercise Research Laboratory, Physical Education School, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil. Electronic address: rafael.grazioli@ufrgs.br.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Lopez', 'Affiliation': 'Exercise Research Laboratory, Physical Education School, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Carlos L F', 'Initials': 'CLF', 'LastName': 'Machado', 'Affiliation': 'Exercise Research Laboratory, Physical Education School, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Juliano B', 'Initials': 'JB', 'LastName': 'Farinha', 'Affiliation': 'Exercise Research Laboratory, Physical Education School, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Alex O', 'Initials': 'AO', 'LastName': 'Fagundes', 'Affiliation': 'Exercise Research Laboratory, Physical Education School, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Rogério', 'Initials': 'R', 'LastName': 'Voser', 'Affiliation': 'Exercise Research Laboratory, Physical Education School, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Reischak-Oliveira', 'Affiliation': 'Exercise Research Laboratory, Physical Education School, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Setuain', 'Affiliation': 'Department of Health Sciences, Public University of Navarra, Tudela, Navarra, Spain.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Department of Health Sciences, Public University of Navarra, Tudela, Navarra, Spain.'}, {'ForeName': 'Ronei S', 'Initials': 'RS', 'LastName': 'Pinto', 'Affiliation': 'Exercise Research Laboratory, Physical Education School, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Eduardo L', 'Initials': 'EL', 'LastName': 'Cadore', 'Affiliation': 'Exercise Research Laboratory, Physical Education School, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.05.019']
3451,31987547,"Effects of Dance/Movement Training vs. Aerobic Exercise Training on cognition, physical fitness and quality of life in older adults: A randomized controlled trial.","INTRODUCTION


It is generally accepted that physical activity promotes healthy aging. Recent studies suggest dance could also benefit cognition and physical health in seniors, but many styles and approaches of dance exist and rigorous designs for intervention studies are still scarce. The aim of this study was to compare the effects of Dance/Movement Training (DMT) to Aerobic Exercise Training (AET) on cognition, physical fitness and health-related quality of life in healthy inactive elderly.
METHODS


A single-center, randomized, parallel assignment, open label trial was conducted with 62 older adults (mean age = 67.48 ± 5.37 years) recruited from the community. Participants were randomly assigned to a 12-week (3x/week, 1hr/session) DMT program, AET program or control group. Cognitive functioning, physical fitness and health-related quality of life were assessed at baseline (T-0), and post-training (T-12 weeks).
RESULTS


41 participants completed the study. Executive and non-executive composite scores showed a significant increase post-training (F (1,37)  = 4.35, p = .04; F (1,37)  = 7.01, p = .01). Cardiovascular fitness improvements were specific to the AET group (F (2,38)  = 16.40, p < .001) while mobility improvements were not group-dependent (10 m walk: F (1,38)  = 11.67, p = .002; Timed up and go: F (1,38)  = 22.07, p < .001).
CONCLUSIONS


Results suggest that DMT may have a positive impact on cognition and physical functioning in older adults however further research is needed. This study could serve as a model for designing future RCTs with dance-related interventions. REGISTRATION: clinicaltrials. gov Identifier NCT02455258.",2020,"Cardiovascular fitness improvements were specific to the AET group (F (2,38)  = 16.40, p < .001) while mobility improvements were not group-dependent (10 m walk: F (1,38)  = 11.67, p = .002; Timed up and go: F (1,38)  = 22.07, p < .001).
","['41 participants completed the study', 'older adults', '62 older adults (mean age\u202f=\u202f67.48\u202f±\u202f5.37 years) recruited from the community', 'healthy inactive elderly']","['Dance/Movement Training vs. Aerobic Exercise Training', 'DMT', 'Dance/Movement Training (DMT) to Aerobic Exercise Training (AET']","['cognition and physical functioning', 'mobility improvements', 'Executive and non-executive composite scores', 'Cognitive functioning, physical fitness and health-related quality of life', 'Cardiovascular fitness improvements', 'cognition, physical fitness and health-related quality of life', 'cognition, physical fitness and quality of life']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}]","[{'cui': 'C0010963', 'cui_str': 'Dancing'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0027183', 'cui_str': 'Dimethyltryptamine'}, {'cui': 'C0629582', 'cui_str': 'AETS'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",62.0,0.0441,"Cardiovascular fitness improvements were specific to the AET group (F (2,38)  = 16.40, p < .001) while mobility improvements were not group-dependent (10 m walk: F (1,38)  = 11.67, p = .002; Timed up and go: F (1,38)  = 22.07, p < .001).
","[{'ForeName': 'Alida', 'Initials': 'A', 'LastName': 'Esmail', 'Affiliation': 'School of Rehabilitation, Faculty of Medicine, Université de Montréal, Montreal, Canada; Institut Universitaire sur La Réadaptation en Déficience Physique de Montréal, Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal, Montreal, Canada.'}, {'ForeName': 'Tudor', 'Initials': 'T', 'LastName': 'Vrinceanu', 'Affiliation': 'Research Centre, Montreal Heart Institute, Montreal, Canada; Research Centre, Institut Universitaire de Gériatrie de Montréal, Montreal, Canada; Department of Medicine, Université de Montréal, Montreal, Canada.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Lussier', 'Affiliation': 'School of Rehabilitation, Faculty of Medicine, Université de Montréal, Montreal, Canada; Research Centre, Institut Universitaire de Gériatrie de Montréal, Montreal, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Predovan', 'Affiliation': 'Research Centre, Institut Universitaire de Gériatrie de Montréal, Montreal, Canada; Department of Psychology, Université Du Québec à Montréal, Montreal, Canada.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Berryman', 'Affiliation': ""Research Centre, Institut Universitaire de Gériatrie de Montréal, Montreal, Canada; Department of Sports Studies, Bishop's University, Sherbrooke, Canada.""}, {'ForeName': 'Janie', 'Initials': 'J', 'LastName': 'Houle', 'Affiliation': 'Department of Psychology, Université Du Québec à Montréal, Montreal, Canada; Research Centre, Institut Universitaire en Santé Mentale de Montréal, Montreal, Canada.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Karelis', 'Affiliation': 'Research Centre, Institut Universitaire de Gériatrie de Montréal, Montreal, Canada; Department of Exercise Science, Université Du Québec à Montréal, Montreal, Canada.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Grenier', 'Affiliation': 'Research Centre, Institut Universitaire de Gériatrie de Montréal, Montreal, Canada; Department of Psychology, Université de Montréal, Montreal, Canada.'}, {'ForeName': 'Thien Tuong', 'Initials': 'TT', 'LastName': 'Minh Vu', 'Affiliation': ""Department of Medicine, Université de Montréal, Montreal, Canada; Centre Hospitalier de L'Université de Montréal, Montreal, Canada.""}, {'ForeName': 'Juan Manuel', 'Initials': 'JM', 'LastName': 'Villalpando', 'Affiliation': 'Research Centre, Institut Universitaire de Gériatrie de Montréal, Montreal, Canada.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Bherer', 'Affiliation': 'Research Centre, Montreal Heart Institute, Montreal, Canada; Research Centre, Institut Universitaire de Gériatrie de Montréal, Montreal, Canada; Department of Medicine, Université de Montréal, Montreal, Canada; PERFORM Centre and Department of Psychology, Concordia University, Montreal, Canada. Electronic address: louis.bherer@umontreal.ca.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.05.004']
3452,31990350,Neonatal BCG Vaccination Reduces Interferon-γ Responsiveness to Heterologous Pathogens in Infants From a Randomized Controlled Trial.,"BACKGROUND


BCG vaccination has beneficial nonspecific (heterologous) effects that protect against nonmycobacterial infections. We have previously reported that BCG vaccination at birth alters in vitro cytokine responses to heterologous stimulants in the neonatal period. This study investigated heterologous responses in 167 infants in the same trial 7 months after randomization.
METHODS


A whole-blood assay was used to interrogate in vitro cytokine responses to heterologous stimulants (killed pathogens) and Toll-like receptor (TLR) ligands.
RESULTS


Compared to BCG-naive infants, BCG-vaccinated infants had increased production of interferon gamma (IFN-γ) and monokine induced by gamma interferon (MIG) (CXCL9) in response to mycobacterial stimulation and decreased production of IFN-γ in response to heterologous stimulation and TLR ligands. Reduced IFN-γ responses were attributable to a decrease in the proportion of infants who mounted a detectable IFN-γ response. BCG-vaccinated infants also had increased production of MIG (CXCL9) and interleukin-8 (IL-8), and decreased production of IL-10, macrophage inflammatory protein-1α (MIP-1α), and MIP-1β, the pattern of which varied by stimulant. IL-1Ra responses following TLR1/2 (Pam3CYSK4) stimulation were increased in BCG-vaccinated infants. Both sex and maternal BCG vaccination status influenced the effect of neonatal BCG vaccination.
CONCLUSIONS


BCG vaccination leads to changes in IFN-γ responsiveness to heterologous stimulation. BCG-induced changes in other cytokine responses to heterologous stimulation vary by pathogen.",2020,"BCG-vaccinated infants also had increased production of MIG and IL-8, and decreased production of IL-10, MIP-1α and MIP-1ß, the pattern of which varied by stimulant.",['167 infants in the same trial seven months after randomisation'],"['Neonatal BCG vaccination', 'Bacille Calmette-Guérin (BCG) vaccination', 'heterologous stimulants (killed pathogens) and Toll-like receptor (TLR) ligands']","['IL-1Ra responses following TLR1/2 (Pam3CYSK4) stimulation', 'IFN-γ responses', 'production of MIG and IL-8, and decreased production of IL-10, MIP-1α and MIP-1ß', 'production of MIG and IFN-γ', 'IFN-γ responsiveness']","[{'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0199804', 'cui_str': 'BCG immunization'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0439860', 'cui_str': 'Heterologous (qualifier value)'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C4521763', 'cui_str': 'Killed'}, {'cui': 'C0670896'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}]","[{'cui': 'C1704264', 'cui_str': 'IL-1 Inhibitor, Urine'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0033268'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]",,0.105443,"BCG-vaccinated infants also had increased production of MIG and IL-8, and decreased production of IL-10, MIP-1α and MIP-1ß, the pattern of which varied by stimulant.","[{'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Freyne', 'Affiliation': ""Infectious Diseases and Microbiology Group, Murdoch Children's Research Institute, Royal Children's Hospital Melbourne, Parkville, Australia.""}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Messina', 'Affiliation': ""Infectious Diseases and Microbiology Group, Murdoch Children's Research Institute, Royal Children's Hospital Melbourne, Parkville, Australia.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Donath', 'Affiliation': 'Department of Paediatrics, The University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Susie', 'Initials': 'S', 'LastName': 'Germano', 'Affiliation': ""Infectious Diseases and Microbiology Group, Murdoch Children's Research Institute, Royal Children's Hospital Melbourne, Parkville, Australia.""}, {'ForeName': 'Rhian', 'Initials': 'R', 'LastName': 'Bonnici', 'Affiliation': ""Infectious Diseases and Microbiology Group, Murdoch Children's Research Institute, Royal Children's Hospital Melbourne, Parkville, Australia.""}, {'ForeName': 'Kaya', 'Initials': 'K', 'LastName': 'Gardiner', 'Affiliation': ""Infectious Diseases and Microbiology Group, Murdoch Children's Research Institute, Royal Children's Hospital Melbourne, Parkville, Australia.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Casalaz', 'Affiliation': 'Department of Paediatrics, Mercy Hospital for Women, Heidelberg, Australia.'}, {'ForeName': 'Roy M', 'Initials': 'RM', 'LastName': 'Robins-Browne', 'Affiliation': ""Infectious Diseases and Microbiology Group, Murdoch Children's Research Institute, Royal Children's Hospital Melbourne, Parkville, Australia.""}, {'ForeName': 'Mihai G', 'Initials': 'MG', 'LastName': 'Netea', 'Affiliation': 'Department of Internal Medicine, Radboud Institute for Molecular Life Sciences, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Flanagan', 'Affiliation': 'University of Tasmania, Launceston, Australia.'}, {'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Kollmann', 'Affiliation': 'Department of Experimental Medicine, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Curtis', 'Affiliation': ""Infectious Diseases and Microbiology Group, Murdoch Children's Research Institute, Royal Children's Hospital Melbourne, Parkville, Australia.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of infectious diseases,['10.1093/infdis/jiaa030']
3453,31892668,Intermittent theta burst stimulation applied during early rehabilitation after stroke: study protocol for a randomised controlled trial.,"INTRODUCTION


Intermittent theta burst stimulation (iTBS) applied to primary motor cortex (M1) has been shown to modulate both the excitability and connectivity of the motor system. A recent proof-of-principle study, based on a small group of hospitalised patients with acute ischemic stroke, suggested that iTBS applied to the ipsilesional M1 combined with physical therapy early after stroke can amplify motor recovery with lasting after effects. A randomised controlled clinical trial using a double-blind design is warranted to justify the implementation of iTBS-assisted motor rehabilitation in neurorehabilitation from an acute ischaemic stroke.
METHODS/DESIGN


We investigate the effects of daily iTBS on early motor rehabilitation after stroke in an investigator-initiated, longitudinal randomised controlled trial. Patients (n=150) with hemiparesis receive either iTBS (600 pulses) applied to the ipsilesional motor cortex (M1) or a control stimulation (ie, coil placement over the parieto-occipital vertex in parallel to the interhemispheric fissure and with a tilt of 45°). On 8 consecutive workdays, a 45 min arm-centred motor training follows the intervention . The relative grip strength, defined as the grip force ratios of the affected and unaffected hands, serves as the primary outcome parameter. Secondary outcome parameters are measures of arm function (Action Research Arm Test, Fugl-Meyer Motor Scale), stroke severity (National Institutes of Health Stroke Scale), stroke-induced disability (modified Rankin Scale, Barthel Index), duration of inpatient rehabilitation, quality of life (EuroQol 5D), motor evoked potentials and the resting motor threshold of the ipsilesional M1.
ETHICS AND DISSEMINATION


The study was approved by the Ethics Commission of the Medical Faculty, University of Cologne, Germany (reference number 15-343). Data will be disseminated through peer-reviewed publications and presentations at conferences. Study title: Theta-Burst Stimulation in Early Rehabilitation after Stroke (acronym: TheSiReS). Study registration at German Registry for Clinical Trials (DRKS00008963) and at ClinicalTrials.gov (NCT02910024).",2019,"Secondary outcome parameters are measures of arm function (Action Research Arm Test, Fugl-Meyer Motor Scale), stroke severity (National Institutes of Health Stroke Scale), stroke-induced disability (modified Rankin Scale, Barthel Index), duration of inpatient rehabilitation, quality of life (EuroQol 5D), motor evoked potentials and the resting motor threshold of the ipsilesional M1.
","['hospitalised patients with acute ischemic stroke', 'Patients (n=150) with hemiparesis receive either']","['iTBS-assisted motor rehabilitation', 'daily iTBS', 'Intermittent theta burst stimulation (iTBS', 'iTBS (600 pulses) applied to the ipsilesional motor cortex (M1) or a control stimulation (ie, coil placement over the parieto-occipital vertex in parallel to the interhemispheric fissure and with a tilt of 45°', 'Intermittent theta burst stimulation']","['measures of arm function (Action Research Arm Test, Fugl-Meyer Motor Scale), stroke severity (National Institutes of Health Stroke Scale), stroke-induced disability (modified Rankin Scale, Barthel Index), duration of inpatient rehabilitation, quality of life (EuroQol 5D), motor evoked potentials and the resting motor threshold of the ipsilesional M1', 'relative grip strength']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0457436', 'cui_str': 'Left hemiparesis (disorder)'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0026607', 'cui_str': 'Somatomotor Areas'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0230003', 'cui_str': 'Vertex structure'}, {'cui': 'C0228186', 'cui_str': 'Structure of longitudinal cerebral fissure'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C4720875', 'cui_str': 'Action research arm test'}, {'cui': 'C0222045'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0034380'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0282617', 'cui_str': 'Evoked Potentials, Motor'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}]",600.0,0.112785,"Secondary outcome parameters are measures of arm function (Action Research Arm Test, Fugl-Meyer Motor Scale), stroke severity (National Institutes of Health Stroke Scale), stroke-induced disability (modified Rankin Scale, Barthel Index), duration of inpatient rehabilitation, quality of life (EuroQol 5D), motor evoked potentials and the resting motor threshold of the ipsilesional M1.
","[{'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Hensel', 'Affiliation': 'Department of Neurology, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Grefkes', 'Affiliation': 'Department of Neurology, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Tscherpel', 'Affiliation': 'Department of Neurology, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Ringmaier', 'Affiliation': 'Department of Neurology, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Daria', 'Initials': 'D', 'LastName': 'Kraus', 'Affiliation': 'Clinical Trials Center Cologne, University of Cologne, Cologne, Germany, Cologne, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Hamacher', 'Affiliation': 'Institute of Medical Statistics and Computational Biology, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Lukas J', 'Initials': 'LJ', 'LastName': 'Volz', 'Affiliation': 'Department of Neurology, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Gereon R', 'Initials': 'GR', 'LastName': 'Fink', 'Affiliation': 'Department of Neurology, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany g.r.fink@fz-juelich.de.'}]",BMJ open,['10.1136/bmjopen-2019-034088']
3454,31987536,Phonophoresis of Phyllanthus amarus nanoparticle gel improves functional capacity in individuals with knee osteoarthritis: A randomized controlled trial.,"OBJECTIVE


This study examined the effects of treatment with Phyllanthus amarus nanoparticle gel applied by phonophoresis (PP) and ultrasound therapy (UT) in patients with symptomatic knee osteoarthritis (OA) using a randomized, double-blind, controlled trial.
METHODS


Patients with knee OA (n = 40; mean age ± SD, 64.30 ± 9.71 years), who had visual analogue scale (VAS) scores for knee pain intensity of 68.00 ± 9.58 (UT group) and 71.00 ± 8.74 (PP group, respectively) before treatment, were randomly allocated into two groups. Both groups were treated with an ultrasound program in continuous mode, 1.0 W/cm 2 , 10 min per session, for 10 sessions. Nanoparticles of P. amarus were used in the PP group, whereas a nondrug coupling gel was used in the UT group. The 6-min walk test (6-MWT) was performed to evaluate functional capacity. The VAS and the 6-MWT were evaluated before and after 10 treatment sessions in both groups using a double-blind procedure.
RESULTS


VAS and 6-MWT showed significant improvement after treatment in both groups (p < 0.05). The PP group showed more significant effects than the UT group, in terms of both reducing the VAS pain score (p < 0.05) and improving 6-MWT (p < 0.05).
CONCLUSIONS


PP is suggested as an effective method for the treatment of symptomatic knee OA for reducing pain and improving functional capacity.",2020,"The PP group showed more significant effects than the UT group, in terms of both reducing the VAS pain score (p < 0.05) and improving 6-MWT (p < 0.05).
","['Patients with knee OA (n\u202f=\u202f40; mean age\u202f±\u202fSD, 64.30\u202f±\u202f9.71 years), who had visual analogue scale (VAS) scores for knee pain intensity of 68.00\u202f±\u202f9.58 (UT group) and 71.00\u202f±\u202f8.74 (PP group, respectively) before treatment', 'individuals with knee osteoarthritis', 'patients with symptomatic knee osteoarthritis (OA']","['Phyllanthus amarus nanoparticle gel applied by phonophoresis (PP) and ultrasound therapy (UT', 'ultrasound program', 'Phonophoresis of Phyllanthus amarus nanoparticle gel']","['6-min walk test (6-MWT', 'functional capacity', '6-MWT', 'VAS pain score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}]","[{'cui': 'C0950041', 'cui_str': 'Phyllanthus amarus'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0031582', 'cui_str': 'Phonophoresis'}, {'cui': 'C0041620', 'cui_str': 'Ultrasonic Therapy'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",40.0,0.0437677,"The PP group showed more significant effects than the UT group, in terms of both reducing the VAS pain score (p < 0.05) and improving 6-MWT (p < 0.05).
","[{'ForeName': 'Decha', 'Initials': 'D', 'LastName': 'Pinkaew', 'Affiliation': 'Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand. Electronic address: decha303@gmail.com.'}, {'ForeName': 'Kanokwan', 'Initials': 'K', 'LastName': 'Kiattisin', 'Affiliation': 'Department of Pharmaceutical Sciences. Faculty of Pharmacy, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Khanittha', 'Initials': 'K', 'LastName': 'Wonglangka', 'Affiliation': 'Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Pisittawoot', 'Initials': 'P', 'LastName': 'Awoot', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.04.013']
3455,31987540,Can Qigong improve attention in adolescents? A prospective randomised controlled trial.,"INTRODUCTION


The ability to direct and maintain attention is a prerequisite for learning. Qigong exercises are already commonly practiced in many developed countries to increase attention and memory. The main goal of this study was to examine whether Qigong would improve the attention levels of adolescents (12-14 years of age) when practiced as part of their physical education course.
METHOD


Three groups of 22 individuals were considered: the verum group, which performed true Qigong; the control group, which performed sham, or placebo Qigong; and the waiting list group. In order to evaluate Qigong effects, attention tests (d2) were applied to all groups before the intervention period (t1) and after two and four weeks of practice (t2 and t3, respectively).
RESULTS


At t1, there was no significant difference between the verum, control and waiting list groups in all measurable features. After 4 weeks of exercise, the verum group was significantly superior in all measurable features in comparison to the control group and the waiting list group. Values in the waiting list group were generally worse than in the control group (placebo Qigong), but there was no significant difference between the control and waiting list group, showing that the placebo offered an effect that was not significantly greater than the effect of no intervention at all.
CONCLUSION


'White Ball' Qigong was able to improve attention in adolescents after 4 weeks of practice, leading us to conclude that it may be a useful tool when integrated into physical education classes.",2020,"After 4 weeks of exercise, the verum group was significantly superior in all measurable features in comparison to the control group and the waiting list group.","['Three groups of 22 individuals', 'adolescents (12-14 years of age) when practiced as part of their physical education course']","['placebo', 'Qigong exercises', 'placebo Qigong; and the waiting list group']",[],"[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0031805', 'cui_str': 'Physical Education'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0282077', 'cui_str': ""Ch'i Kung""}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],22.0,0.0324212,"After 4 weeks of exercise, the verum group was significantly superior in all measurable features in comparison to the control group and the waiting list group.","[{'ForeName': 'Leonel', 'Initials': 'L', 'LastName': 'Duarte', 'Affiliation': 'ICBAS - Institute of Biomedical Sciences, University of Porto, 4099-030, Porto, Portugal.'}, {'ForeName': 'Mário', 'Initials': 'M', 'LastName': 'Gonçalves', 'Affiliation': 'ICBAS - Institute of Biomedical Sciences, University of Porto, 4099-030, Porto, Portugal; DGTCM - German Society of Traditional Chinese Medicine, 69126, Heidelberg, Germany; HSCM - Heidelberg School of Chinese Medicine, 69126, Heidelberg, Germany.'}, {'ForeName': 'Patrícia', 'Initials': 'P', 'LastName': 'Mendes', 'Affiliation': 'UM-EP University of Minho - School of Psychology, 4710 - 057, Braga, Portugal.'}, {'ForeName': 'Luís Carlos', 'Initials': 'LC', 'LastName': 'Matos', 'Affiliation': 'Faculdade de Engenharia da Universidade do Porto, Rua Dr. Roberto Frias, s/n, 4200-465, Porto, Portugal.'}, {'ForeName': 'Henry Johannes', 'Initials': 'HJ', 'LastName': 'Greten', 'Affiliation': 'ICBAS - Institute of Biomedical Sciences, University of Porto, 4099-030, Porto, Portugal; DGTCM - German Society of Traditional Chinese Medicine, 69126, Heidelberg, Germany; HSCM - Heidelberg School of Chinese Medicine, 69126, Heidelberg, Germany.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Machado', 'Affiliation': 'ICBAS - Institute of Biomedical Sciences, University of Porto, 4099-030, Porto, Portugal; LABIOMEP - Biomechanics Laboratory of Porto, University of Porto, 4200-450, Porto, Portugal. Electronic address: jmachado@icbas.up.pt.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.05.005']
3456,31567872,FADS1 and FADS2 polymorphism are associated with changes in fatty acid concentrations after calorie-restricted Central European and Mediterranean diets.,"OBJECTIVE


In the present study, we tested whether calorie-restricted diets differing in their percentage of energy derived from monounsaturated fatty acids and carbohydrates can affect the metabolism of fatty acids (FAs) in postmenopausal women. Moreover, we examined whether polymorphisms of FADS1 and FADS2 are associated with these changes.
METHODS


Postmenopausal women (the mean age: 60.5 ± 5.0 y) were randomized for 16 weeks to two different calorie-restricted diets: a Central European diet (CED) or a Mediterranean diet (MED).
RESULTS


After the intervention, levels of most FAs in red blood cells decreased in both groups. The delta values for the 20:1n-9 and the 20:2n-6 levels differed between the CED and the MED (-1.55 ± 4.02 μg/mL vs 0.39 ± 4.11 μg/mL and -0.62 ± 10.93 μg/mL vs 3.06 ± 8.75 μg/mL; P < 0.05). Women in the CED group with at least one minor allele of FADS genes had greater decreases of α-linolenic acid, dihomo-γ-linolenic acid, total n-6, and total PUFA (by approximately 70%, 40%, 35%, and 35%, respectively) than did women with the major alleles. After the intervention, the change in the lipid accumulation product index was -28.28 ± 27.84 and -32.00 ± 78.55 in the CED and the MED group, respectively.
CONCLUSIONS


The effect of the dietary intervention on FA metabolism seems to depend mostly on calorie restriction, but not on type of diet. FADS1 and FADS2 gene polymorphisms can modify the response to the CED.",2019,"After the intervention, the change in the lipid accumulation product index was -28.28 ± 27.84 and -32.00 ± 78.55 in the CED and the MED group, respectively.
","['postmenopausal women', 'Postmenopausal women (the mean age: 60.5 ± 5.0 y']","['CED', 'calorie-restricted diets: a Central European diet (CED) or a Mediterranean diet (MED', 'dietary intervention', 'FADS1 and FADS2']","['α-linolenic acid, dihomo-γ-linolenic acid, total n-6, and total PUFA', 'levels of most FAs in red blood cells', 'fatty acid concentrations', 'delta values', 'lipid accumulation product index']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}]","[{'cui': 'C0125903', 'cui_str': 'Linolenic Acid'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C3658347', 'cui_str': 'Lipid Accumulation Product'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0622075,"After the intervention, the change in the lipid accumulation product index was -28.28 ± 27.84 and -32.00 ± 78.55 in the CED and the MED group, respectively.
","[{'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Muzsik', 'Affiliation': 'Institute of Human Nutrition and Dietetics, Poznań University of Life Sciences, Poznań, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Bajerska', 'Affiliation': 'Institute of Human Nutrition and Dietetics, Poznań University of Life Sciences, Poznań, Poland.'}, {'ForeName': 'Henryk H', 'Initials': 'HH', 'LastName': 'Jeleń', 'Affiliation': 'Institute of Food Technology of Plant Origin, Poznań University of Life Sciences, Poznań, Poland.'}, {'ForeName': 'Jarosław', 'Initials': 'J', 'LastName': 'Walkowiak', 'Affiliation': 'First Subdepartment of Pediatrics, Department of Pediatric Gastroenterology and Metabolism, Poznań University of Medical Sciences, Poznań, Poland.'}, {'ForeName': 'Patrycja', 'Initials': 'P', 'LastName': 'Krzyżanowska-Jankowska', 'Affiliation': 'First Subdepartment of Pediatrics, Department of Pediatric Gastroenterology and Metabolism, Poznań University of Medical Sciences, Poznań, Poland.'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Chmurzynska', 'Affiliation': 'Institute of Human Nutrition and Dietetics, Poznań University of Life Sciences, Poznań, Poland.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001409']
3457,31987528,The effect of treatment regimens on salivary cortisol levels in patients with chronic musculoskeletal disorders.,"BACKGROUND


Increased levels of circulating cortisol have been associated with pain severity in patients with chronic musculoskeletal disorders (CMD). Little is known about the potential association between pain management and salivary cortisol alterations in CPM patients treated with different regimens.
OBJECTIVES


This prospective feasibility study aimed to determine the effect of two treatment regimens in comparison with sham therapy on pain intensity and disability and salivary cortisol concentration (SCC) in patients with CMD.
METHODS


Thirty patients were randomly assigned to 3 groups of 10: two experimental groups (A and B) and a control group (C). The experimental groups followed physiotherapy treatment (A) or acupuncture (B), while the control group (C) followed a sham therapy for 10 sessions. Pain data were collected using the Chronic Pain Grade (CPG) questionnaire and SCC was measured by enzyme-linked immunosorbent assay at pre- and posttreatment.
RESULTS


Repeated-measures analysis of variance showed that patients treated with acupuncture experienced greater decreases in pain intensity/pain disability (P < 0.05) than the physiotherapy and sham therapy groups. No statistical differences were found between the three groups for the SCC outcome variable. Bonferroni adjustments showed that the mean values of SCC were significantly decreased at posttreatment (P < 0.05) across the three groups.
CONCLUSION


There was a significant decrease in both pain and cortisol outcomes at posttreatment in patients with CMD. Because of the limitations of this study, we cannot draw conclusions regarding whether the lower SCC could be an indication of pain reduction in patients with CMD.",2020,"RESULTS


Repeated-measures analysis of variance showed that patients treated with acupuncture experienced greater decreases in pain intensity/pain disability (P < 0.05) than the physiotherapy and sham therapy groups.","['patients with chronic musculoskeletal disorders (CMD', 'patients with CMD', 'Thirty patients', 'patients with chronic musculoskeletal disorders']","['physiotherapy treatment (A) or acupuncture (B), while the control group (C) followed a sham therapy', 'acupuncture']","['salivary cortisol levels', 'pain intensity and disability and salivary cortisol concentration (SCC', 'mean values of SCC', 'pain intensity/pain disability', 'pain management and salivary cortisol alterations', 'Pain data', 'pain and cortisol outcomes', 'Chronic Pain Grade (CPG) questionnaire and SCC']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1290136', 'cui_str': 'Chronic musculoskeletal disorder'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",30.0,0.0359962,"RESULTS


Repeated-measures analysis of variance showed that patients treated with acupuncture experienced greater decreases in pain intensity/pain disability (P < 0.05) than the physiotherapy and sham therapy groups.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Papandreou', 'Affiliation': 'Physiotherapy Department, Athens University of West Attica, Greece. Electronic address: mpapand@uniwa.gr.'}, {'ForeName': 'Anastassios', 'Initials': 'A', 'LastName': 'Philippou', 'Affiliation': 'Department of Physiology, Faculty of Medicine, National and Kapodistrian University of Athens, Greece. Electronic address: tfilipou@med.uoa.gr.'}, {'ForeName': 'Orjona', 'Initials': 'O', 'LastName': 'Taso', 'Affiliation': 'Department of Physiology, Faculty of Medicine, National and Kapodistrian University of Athens, Greece. Electronic address: orjona.taso.17@ucl.ac.uk.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Koutsilieris', 'Affiliation': 'Department of Physiology, Faculty of Medicine, National and Kapodistrian University of Athens, Greece. Electronic address: mkoutsil@med.uoa.gr.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kaperda', 'Affiliation': 'Anaesthetology Department, ""Sotiria"" Thoracic Diseases Hospital, Athens, Greece. Electronic address: katath04@yahoo.gr.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.10.010']
3458,31987542,Effectiveness of traditional Thai self-massage combined with stretching exercises for the treatment of patients with chronic non-specific low back pain: A single-blinded randomized controlled trial.,"INTRODUCTION


The aim of this study was to determine the effects of traditional Thai self-massage combined with home stretching exercises (TSMSE) on pain, back flexibility and disability in patients with chronic non-specific low back pain (NSLBP).
METHODS


Twenty-two patients from 18 to 60 years old were randomly allocated to receive 30-min sessions of TSMSE or 12 sessions of self-care education (SCE) over a period of 4 weeks. The pain intensity using a visual analog scale (VAS), back flexibility using a sit-and-reach test, and disability using the Oswestry Low Back Pain Disability questionnaire, were measured before and after the treatment period.
RESULTS


The results indicated that the TSMSE group showed significant improvements in all of the parameters after the 4-week treatment period (p < 0.05). However, the SCE group only showed significant improvement in the pain intensity (p < 0.05). Moreover, the TSMSE group demonstrated a greater improvement in back flexibility than the SCE group at the end of the treatment period (p < 0.05).
CONCLUSION


These results suggest that the TSMSE treatment was an effective intervention for decreasing pain and disability and increasing back flexibility among the NSLBP patients.",2020,The results indicated that the TSMSE group showed significant improvements in all of the parameters after the 4-week treatment period (p < 0.05).,"['Twenty-two patients from 18 to 60 years old', 'patients with chronic non-specific low back pain', 'patients with chronic non-specific low back pain (NSLBP']","['traditional Thai self-massage combined with stretching exercises', 'TSMSE or 12 sessions of self-care education (SCE', 'traditional Thai self-massage combined with home stretching exercises (TSMSE', 'SCE', 'TSMSE']","['pain intensity', 'pain, back flexibility and disability', 'pain intensity using a visual analog scale (VAS), back flexibility using a sit-and-reach test, and disability using the Oswestry Low Back Pain Disability questionnaire', 'back flexibility', 'pain and disability and increasing back flexibility']","[{'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0337910', 'cui_str': 'Thai'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",22.0,0.0331864,The results indicated that the TSMSE group showed significant improvements in all of the parameters after the 4-week treatment period (p < 0.05).,"[{'ForeName': 'Vitsarut', 'Initials': 'V', 'LastName': 'Buttagat', 'Affiliation': 'Department of Physical Therapy, School of Health Science, Mae Fah Luang University, Chiang Rai, 57100, Thailand. Electronic address: vitsarutbut@hotmail.com.'}, {'ForeName': 'Palida', 'Initials': 'P', 'LastName': 'Techakhot', 'Affiliation': 'Department of Physical Therapy, School of Health Science, Mae Fah Luang University, Chiang Rai, 57100, Thailand.'}, {'ForeName': 'Waraporn', 'Initials': 'W', 'LastName': 'Wiriya', 'Affiliation': 'Department of Physical Therapy, School of Health Science, Mae Fah Luang University, Chiang Rai, 57100, Thailand.'}, {'ForeName': 'Mailusie', 'Initials': 'M', 'LastName': 'Mueller', 'Affiliation': 'Department of Physical Therapy, School of Health Science, Mae Fah Luang University, Chiang Rai, 57100, Thailand.'}, {'ForeName': 'Pattanasin', 'Initials': 'P', 'LastName': 'Areeudomwong', 'Affiliation': 'Department of Physical Therapy, School of Health Science, Mae Fah Luang University, Chiang Rai, 57100, Thailand.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.03.017']
3459,31987543,"High-velocity, low-amplitude manipulation (HVLA) does not alter three-dimensional position of sacroiliac joint in healthy men: A quasi-experimental study.","The impact of high-velocity, low-amplitude (HVLA) manipulations on the behavior of sacroiliac joint (SIJ) mobility in individuals submitted to an osteopathic intervention has not been sufficiently investigated. Furthermore, there is no standard agreement on the description of the acute effects of HLVA with regards to the mobility of the SIJ through three-dimensional motion analysis. The purpose of this study was to analyse possible alterations in the mobility of the SIJ pre- and post-manipulation of the ilium bone in healthy men. Thirty healthy male patients aged between 18 and 35 years were examined and divided into two groups: manipulation (MN) and placebo (PL) groups. SIJ movement was assessed through a three-dimensional motion analysis system before and after osteopathic manipulation of the anterior ilium bone, during hip flexion. Statistical analysis was performed using the Kolmogorov-Smirnov normality test, and Fisher's exact test was used to observe associations of interest in the mobility of the SIJ. Finally, the t-test was used to analyse values of mobility of the SIJ pre- and post-manipulation (p < 0.05). Non-significant differences were observed in SIJ mobility. In MN the means were pre-manipulation right SIJ 39.98 mm ± 10.82 [CI - 29.16-50.8] and post- 42.85 mm ± 27.17 [CI - 15.68-70.02] with p = 0.61. Pre-manipulation left SIJ 41.73 mm ± 15.34 [CI 10.89-82.99] and post- 39.97 mm ± 14.70 [CI - 24.67-54.07] with p = 0.39. HVLA does not alter the mobility of SIJ under these conditions. Further studies under different conditions, with patients that report pain, are required to fully understand the behavior of the SIJ after HVLA manipulation.",2020,"SIJ movement was assessed through a three-dimensional motion analysis system before and after osteopathic manipulation of the anterior ilium bone, during hip flexion.","['healthy men', 'Thirty healthy male patients aged between 18 and 35 years']","['manipulation (MN) and placebo (PL', 'High-velocity, low-amplitude manipulation (HVLA', 'high-velocity, low-amplitude (HVLA) manipulations', 'HVLA']","['values of mobility of the SIJ pre- and post-manipulation', 'mobility of SIJ', 'SIJ mobility', 'behavior of sacroiliac joint (SIJ) mobility']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0036036', 'cui_str': 'Sacroiliac Joint'}]",30.0,0.0601789,"SIJ movement was assessed through a three-dimensional motion analysis system before and after osteopathic manipulation of the anterior ilium bone, during hip flexion.","[{'ForeName': 'Danielle de Faria Alvim', 'Initials': 'DFA', 'LastName': 'de Toledo', 'Affiliation': 'Rehabilitation Sciences Postgraduate Program, Augusto Motta University Center (UNISUAM), Rio de Janeiro, Brazil.'}, {'ForeName': 'Frederico Barreto', 'Initials': 'FB', 'LastName': 'Kochem', 'Affiliation': 'Rehabilitation Science PhD Program, Augusto Motta University Center (UNISUAM), Rio de Janeiro, Brazil.'}, {'ForeName': 'Julio Guilherme', 'Initials': 'JG', 'LastName': 'Silva', 'Affiliation': 'Rehabilitation Science Master and PhD Program, Augusto Motta University Center (UNISUAM), Rio de Janeiro, Brazil; Physical Therapy Department - Federal University of Rio de Janeiro (UFRJ), Brazil; Research group at Manual Therapies (GETEM-UFRJ), Brazil. Electronic address: jgsilva@hucff.ufrj.br.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.05.020']
3460,31987544,Upper limb robot-assisted rehabilitation versus physical therapy on subacute stroke patients: A follow-up study.,"This study aims to analyse the long-term effects (6 months follow-up) of upper limb Robot-assisted Therapy (RT) compared to Traditional physical Therapy (TT), in subacute stroke patients. Although the literature on upper-limb rehabilitation with robots shows increasing evidence of its effectiveness in stroke survivors, the length of time for which the re-learned motor abilities could be maintained is still understudied. A randomized controlled follow-up study was conducted on 48 subacute stroke patients who performed the upper-limb therapy using a planar end-effector robotic system (Experimental Group-EG) or TT (Control Group-CG). The clinical assessments were collected at T0 (baseline), T1 (end of treatment) and T2 (6 months follow-up): Upper Limb part of Fugl-Meyer assessment (FM-UL), total passive Range Of Motion (pROM), Modified Ashworth Scale Shoulder (MAS-S) and Elbow (MAS-E). At T1, the intra-group analysis showed significant gain of FM-UL in both EG and CG, while significant improvement in MAS-S, MAS-E, and pROM were found in the EG only. At T2, significant increase in MAS-S were revealed only in the CG. In FM-UL, pROM and MAS-E the improvements obtained at the end of treatment seem to be maintained at 6 months follow-up in both groups. The inter-groups analysis of FM-UL values at T1 and T2 demonstrated significant differences in favour of EG. In conclusion, upper limb Robot-assisted Therapy may lead a greater reduction of motor impairment in subacute stroke patients compared to Traditional Therapy. The gains observed at the end of treatment persisted over time. No serious adverse events related to the study occurred.",2020,The inter-groups analysis of FM-UL values at T1 and T2 demonstrated significant differences in favour of EG.,"['subacute stroke patients', '48 subacute stroke patients who performed the']","['upper-limb therapy using a planar end-effector robotic system (Experimental Group-EG) or TT (Control Group-CG', 'Traditional physical Therapy (TT', 'upper limb Robot-assisted Therapy (RT', 'Upper limb robot-assisted rehabilitation versus physical therapy']","['MAS-S, MAS-E, and pROM', 'Upper Limb part of Fugl-Meyer assessment (FM-UL), total passive Range Of Motion (pROM), Modified Ashworth Scale Shoulder (MAS-S) and Elbow (MAS-E', 'motor impairment', 'MAS-S', 'FM-UL values', 'gain of FM-UL']","[{'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C4543203', 'cui_str': 'Effector (disposition)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0015944', 'cui_str': 'Premature Rupture of Membrane (Pregnancy)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0079991', 'cui_str': 'Passive Range of Motion'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale (assessment scale)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]",48.0,0.013801,The inter-groups analysis of FM-UL values at T1 and T2 demonstrated significant differences in favour of EG.,"[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Franceschini', 'Affiliation': 'Department of Neurorehabilitation, IRCCS San Raffaele Pisana, Via della Pisana, 235, 00163, Rome, Italy; San Raffaele University, Rome, Italy. Electronic address: marco.franceschini@sanraffaele.it.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Mazzoleni', 'Affiliation': ""The BioRobotics Institute, Scuola Superiore Sant'Anna, V.le R. Piaggio 34, 56025, Pisa, Italy; Rehabilitation Bioengineering Laboratory, Volterra, Italy. Electronic address: stefano.mazzoleni@santannapisa.it.""}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Goffredo', 'Affiliation': 'Department of Neurorehabilitation, IRCCS San Raffaele Pisana, Via della Pisana, 235, 00163, Rome, Italy. Electronic address: michela.goffredo@sanraffaele.it.'}, {'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Pournajaf', 'Affiliation': 'Department of Neurorehabilitation, IRCCS San Raffaele Pisana, Via della Pisana, 235, 00163, Rome, Italy. Electronic address: sanaz.pournajaf@sanraffaele.it.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Galafate', 'Affiliation': 'Department of Neurorehabilitation, IRCCS San Raffaele Pisana, Via della Pisana, 235, 00163, Rome, Italy. Electronic address: daniele.galafate@gmail.com.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Criscuolo', 'Affiliation': 'Department of Neurorehabilitation, IRCCS San Raffaele Pisana, Via della Pisana, 235, 00163, Rome, Italy. Electronic address: simone.criscuolo@sanraffaele.it.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Agosti', 'Affiliation': 'Department of Geriatrics and Rehabilitation, University Hospital Parma, Via Gramsci 14, 43126, Parma, Italy. Electronic address: magosti@gmail.com.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Posteraro', 'Affiliation': 'Rehabilitation Bioengineering Laboratory, Volterra, Italy; Rehabilitation Department - Versilia Hospital - AUSL Tuscany North West, Via Aurelia 335, Camaiore - Lucca, Italy. Electronic address: federico.posteraro@uslnordovest.toscana.it.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.03.016']
3461,31342247,Impact of ureteral access sheath on renal stone treatment: prospective comparative non-randomised outcomes over a 7-year period.,"PURPOSE


To compare the outcomes (stone free rate and complications) of renal stone treatment with and without the use of ureteral access sheath (UAS). The worldwide use of UAS has risen over the last decade; however, questions still remain on the safety and outcomes with its use. We wanted to look at the role of UAS for treatment of consecutive renal stones over a 7-year period.
METHODS


The outcomes of flexible ureteroscopy and stone treatment (FURS) for renal stones with and without the use of UAS was prospectively compared from March 2012 to July 2018. Patients were divided into two groups: group-1 where UAS was used for stone treatment and group-2 where a UAS was not used. Data were collected prospectively on consecutive patients for demographics, stone size, location and number, pre and post-operative stent usage, operative time duration, stone free rate (SFR), length of stay and complications.
RESULTS


During the study period, 338 patients underwent FURS for renal stones, of which a UAS was used for 203 (60%) patients. The mean age of patients was 56 years (range 2-89 years) with a male:female ratio of 204:134. The mean cumulative stone size and the mean number of stones was 16.5 ± 10.8 mm and 11.37 ± 8.08 mm (P < 0.001), and 2.17 ± 1.99 and 1.66 ± 1.50 (P = 0.009) for groups 1 and 2 respectively. The pre and post-operative stent insertion rates were similar in the two groups. The procedural time was longer in group-1 (54.8 ± 25.8 min) compared to group-2 (41.3 ± 22.2 min) (P < 0.001). The SFR for group-1 (88%) was slightly lower than group-2 (94%) although this was not statistically significant (P = 0.07). There were no intra-operative complications in either of the groups. Post-operative complications were seen in eight patients in group-1 (7 Clavien I/II and 1 Clavien IVa) and two patients in group-2 (Clavien I) (P = 0.19).
CONCLUSION


The use of UAS for renal stones is safe with no intra-operative complications noted in our series. Good stone-free rates were obtained for large and multiple renal stones with a small risk of minor complications post-operatively.",2020,Good stone-free rates were obtained for large and multiple renal stones with a small risk of minor complications post-operatively.,"['mean age of patients was 56\xa0years (range 2-89\xa0years) with a male:female ratio of 204:134', '338 patients underwent FURS for renal stones, of which a UAS was used for 203 (60%) patients']","['ureteral access sheath', 'UAS', 'flexible ureteroscopy and stone treatment (FURS', 'renal stone treatment with and without the use of ureteral access sheath (UAS']","['operative time duration, stone free rate (SFR), length of stay and complications', 'procedural time', 'Good stone-free rates', 'mean cumulative stone size and the mean number of stones', 'Post-operative complications', 'intra-operative complications']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0022650', 'cui_str': 'Kidney Stones'}]","[{'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0022650', 'cui_str': 'Kidney Stones'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}, {'cui': 'C0449790', 'cui_str': 'Number of stones (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}]",338.0,0.0282439,Good stone-free rates were obtained for large and multiple renal stones with a small risk of minor complications post-operatively.,"[{'ForeName': 'Ashleigh', 'Initials': 'A', 'LastName': 'Lima', 'Affiliation': 'Department of Urology, University Hospital Southampton NHS Foundation Trust, Wessex Clinical Research Network and Simulation Lead for Urology, Tremona Road, Southampton, SO16 6YD, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Reeves', 'Affiliation': 'Department of Urology, University Hospital Southampton NHS Foundation Trust, Wessex Clinical Research Network and Simulation Lead for Urology, Tremona Road, Southampton, SO16 6YD, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Geraghty', 'Affiliation': 'Department of Urology, University Hospital Southampton NHS Foundation Trust, Wessex Clinical Research Network and Simulation Lead for Urology, Tremona Road, Southampton, SO16 6YD, UK.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Pietropaolo', 'Affiliation': 'Department of Urology, University Hospital Southampton NHS Foundation Trust, Wessex Clinical Research Network and Simulation Lead for Urology, Tremona Road, Southampton, SO16 6YD, UK.'}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Whitehurst', 'Affiliation': 'Department of Urology, University Hospital Southampton NHS Foundation Trust, Wessex Clinical Research Network and Simulation Lead for Urology, Tremona Road, Southampton, SO16 6YD, UK.'}, {'ForeName': 'Bhaskar K', 'Initials': 'BK', 'LastName': 'Somani', 'Affiliation': 'Department of Urology, University Hospital Southampton NHS Foundation Trust, Wessex Clinical Research Network and Simulation Lead for Urology, Tremona Road, Southampton, SO16 6YD, UK. b.k.somani@soton.ac.uk.'}]",World journal of urology,['10.1007/s00345-019-02878-5']
3462,31915166,Rationale and design for studying organisation of care for intra-arterial thrombectomy in the Netherlands: simulation modelling study.,"INTRODUCTION


The introduction of intra-arterial thrombectomy (IAT) challenges acute stroke care organisations to provide fast access to acute stroke therapies. Parameters of pathway performance include distances to primary and comprehensive stroke centres (CSCs), time to treatment and availability of ambulance services. Further expansion of IAT centres may increase treatment rates yet could affect efficient use of resources and quality of care due to lower treatment volume. The aim was to study the organisation of care and patient logistics of IAT for patients with ischaemic stroke in the Netherlands.
METHODS AND ANALYSES


Using a simulation modelling approach, we will quantify performance of 16 primary and CSCs offering IAT in the Netherlands. Patient data concerning both prehospital and intrahospital pathway logistics will be collected and used as input for model validation. A previously validated simulation model for intravenous thrombolysis (IVT) patients will be expanded with data of the MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands) Registry and trials performed in the Collaboration for New Treatments in Acute Stroke consortium to represent patient logistics, time delays and outcomes in IAT patients. Simulation experiments aim to assess effectiveness and efficiency of alternative network topologies, that is, IAT with or without IVT at the nearest primary stroke centre (PSC) versus centralised care at a CSC. Primary outcomes are IAT treatment rates and clinical outcome according to the modified Rankin Scale. Secondary outcomes include onset-to-treatment time and resource use. Mann-Whitney U and Fisher's exact tests will be used to estimate differences for continuous and categorical variables. Model and parameter uncertainty will be tested using sensitivity analyses.
ETHICS AND DISSEMINATION


This will be the first study to examine the organisation of acute stroke care for IAT delivery on a national scale using discrete event simulation. There are no ethics or safety concerns regarding the dissemination of information, which includes publication in peer-reviewed journals and (inter)national conference presentations.
TRIAL REGISTRATION NUMBER


ISRCTN99503308, ISRCTN76741621, ISRCTN19922220, ISRCTN80619088, NCT03608423; Pre-results.",2020,The introduction of intra-arterial thrombectomy (IAT) challenges acute stroke care organisations to provide fast access to acute stroke therapies.,"['IAT patients', 'Acute Ischemic Stroke in the Netherlands', 'patients with ischaemic stroke in the Netherlands']","['intravenous thrombolysis (IVT', 'IAT with or without IVT']","['pathway performance include distances to primary and comprehensive stroke centres (CSCs), time to treatment and availability of ambulance services', 'IAT treatment rates and clinical outcome according to the modified Rankin Scale', 'onset-to-treatment time and resource use']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}]","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C3494202', 'cui_str': 'Time-to-Treatment'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0002422', 'cui_str': 'Ambulances'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",,0.0859053,The introduction of intra-arterial thrombectomy (IAT) challenges acute stroke care organisations to provide fast access to acute stroke therapies.,"[{'ForeName': 'Maarten M H', 'Initials': 'MMH', 'LastName': 'Lahr', 'Affiliation': 'Health Technology Assessment, Department of Epidemiology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands m.m.h.lahr@umcg.nl.'}, {'ForeName': 'Willemijn J', 'Initials': 'WJ', 'LastName': 'Maas', 'Affiliation': 'Health Technology Assessment, Department of Epidemiology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Durk-Jouke', 'Initials': 'DJ', 'LastName': 'van der Zee', 'Affiliation': 'Department of Operations, Faculty of Economics & Business, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Uyttenboogaart', 'Affiliation': 'Department of Neurology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Buskens', 'Affiliation': 'Health Technology Assessment, Department of Epidemiology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2019-032754']
3463,31900274,Levofloxacin versus placebo for the treatment of latent tuberculosis among contacts of patients with multidrug-resistant tuberculosis (the VQUIN MDR trial): a protocol for a randomised controlled trial.,"INTRODUCTION


Treatment of latent tuberculosis infection (LTBI) plays a substantial role in the prevention of drug-susceptible tuberculosis (TB). However, clinical trials to evaluate the efficacy of preventive therapy for presumed multidrug-resistant (MDR) LTBI are lacking. This trial aims to evaluate the efficacy of the antibiotic levofloxacin in preventing the development of active TB among latently infected contacts of index patients with MDR-TB.
METHODS AND ANALYSIS


A double-blind placebo-controlled parallel group randomised controlled trial will be conducted in 10 provinces of Vietnam. Household contacts living with patients with bacteriologically confirmed rifampicin-resistant or MDR-TB will be eligible for recruitment if they have a positive tuberculin skin test or are known to be immunosuppressed, and do not have active TB. Participants will be randomised to receive either levofloxacin or placebo tablets once per day for 6 months. Screening for incident TB will be performed at 6 months intervals. The primary study outcome is the incidence of bacteriologically confirmed TB within 30 months after randomisation. Analysis will be by intention to treat, using Poisson regression.
ETHICS


Ethical approval from the University of Sydney Human Research Ethics Committee was obtained on 29 April 2015 (2014/929), and from the Vietnam Ministry of Health Institutional Review Board on 30 September 2015 (4040/QD-BYT).
DISSEMINATION


Findings of the study will be published in peer-reviewed publications and conference presentations.
TRIAL REGISTRATION NUMBER


ACTRN12616000215426.",2020,"However, clinical trials to evaluate the efficacy of preventive therapy for presumed multidrug-resistant (MDR) LTBI are lacking.","['29 April 2015 (2014/929), and from the Vietnam Ministry of Health Institutional Review Board on 30 September 2015 (4040/QD-BYT', '10 provinces of Vietnam', 'latently infected contacts of index patients with MDR-TB', 'Household contacts living with patients with bacteriologically confirmed rifampicin-resistant or MDR-TB', 'latent tuberculosis among contacts of patients with multidrug-resistant tuberculosis (the VQUIN MDR trial']","['placebo', 'antibiotic levofloxacin', 'Levofloxacin', 'levofloxacin or placebo']",['incidence of bacteriologically confirmed TB'],"[{'cui': 'C0042658', 'cui_str': 'Viet Nam'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0086911', 'cui_str': 'Institutional Review Boards'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C1609538', 'cui_str': 'Latent Tuberculosis Infection'}, {'cui': 'C0206526', 'cui_str': 'Tuberculosis, Multi-Drug Resistant'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0282386', 'cui_str': 'Levofloxacin'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}]",,0.766046,"However, clinical trials to evaluate the efficacy of preventive therapy for presumed multidrug-resistant (MDR) LTBI are lacking.","[{'ForeName': 'Greg J', 'Initials': 'GJ', 'LastName': 'Fox', 'Affiliation': 'Central Clinical School, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia greg.fox@sydney.edu.au.'}, {'ForeName': 'Cam Binh', 'Initials': 'CB', 'LastName': 'Nguyen', 'Affiliation': 'Woolcock Institute of Medical Research, Glebe, New South Wales, Australia.'}, {'ForeName': 'Thu Anh', 'Initials': 'TA', 'LastName': 'Nguyen', 'Affiliation': 'Woolcock Institute of Medical Research, Glebe, New South Wales, Australia.'}, {'ForeName': 'Phuong Thuy', 'Initials': 'PT', 'LastName': 'Tran', 'Affiliation': 'Woolcock Institute of Medical Research, Glebe, New South Wales, Australia.'}, {'ForeName': 'Ben J', 'Initials': 'BJ', 'LastName': 'Marais', 'Affiliation': 'The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia.'}, {'ForeName': 'Steve M', 'Initials': 'SM', 'LastName': 'Graham', 'Affiliation': 'Murdoch Childrens Research Institute, Parkville, Victoria, Australia.'}, {'ForeName': 'Binh Hoa', 'Initials': 'BH', 'LastName': 'Nguyen', 'Affiliation': 'The National Lung Hospital, Hanoi, Vietnam.'}, {'ForeName': 'Kavi', 'Initials': 'K', 'LastName': 'Velen', 'Affiliation': 'Woolcock Institute of Medical Research, Glebe, New South Wales, Australia.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dowdy', 'Affiliation': 'Department of Epidemiology, John Hopkins Bloomberg, Baltimore, Maryland, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Mason', 'Affiliation': 'Taronga Institute of Science and Learning, Taronga Conservation Society, Sydney, New South Wales, Australia.'}, {'ForeName': 'Warwick J', 'Initials': 'WJ', 'LastName': 'Britton', 'Affiliation': 'The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia.'}, {'ForeName': 'Marcel A', 'Initials': 'MA', 'LastName': 'Behr', 'Affiliation': 'Department of Medicine, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Benedetti', 'Affiliation': 'Departments of Medicine and of Epidemiology, Biostatistics & Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Dick', 'Initials': 'D', 'LastName': 'Menzies', 'Affiliation': 'McGill International Tuberculosis Centre, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Viet Nhung', 'Initials': 'VN', 'LastName': 'Nguyen', 'Affiliation': 'The National Lung Hospital, Hanoi, Vietnam.'}, {'ForeName': 'Guy B', 'Initials': 'GB', 'LastName': 'Marks', 'Affiliation': 'Woolcock Institute of Medical Research, Glebe, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-033945']
3464,31911526,Targeted and tailored pharmacist-led intervention to improve adherence to antihypertensive drugs among patients with type 2 diabetes in Indonesia: study protocol of a cluster randomised controlled trial.,"INTRODUCTION


Current intervention programme to improve drug adherence are either too complex or expensive for implementation and scale-up in low-middle-income countries. The aim of this study is to assess the process and effects of implementing a low-cost, targeted and tailored pharmacist intervention among patients with type 2 diabetes who are non-adherent to antihypertensive drugs in a real-world primary care Indonesian setting.
METHODS AND ANALYSIS


A cluster randomised controlled trial with a 3-month follow-up will be conducted in 10 community health centres (CHCs) in Indonesia. Type 2 diabetes patients aged 18 years and older who reported non-adherence to antihypertensive drugs according to the Medication Adherence Report Scale (MARS) are eligible to participate. Patients in CHCs randomised to the intervention group will receive a tailored intervention based on their personal adherence barriers. Interventions may include reminders, habit-based strategies, family support, counselling to educate and motivate patients, and strategies to address other drug-related problems. Interventions will be provided at baseline and at a 1-month follow-up. Simple question-based flowcharts and an innovative adherence intervention wheel are provided to support the pharmacy staff. Patients in CHCs randomised to the control group will receive usual care based on the Indonesian guideline. The primary outcome is the between-group difference in medication adherence change from baseline to 3-month follow-up assessed by MARS. Secondary outcomes include changes in patients' blood pressure, their medication beliefs assessed by the Beliefs about Medicines Questionnaire (BMQ)-specific, as well as process characteristics of the intervention programme from a pharmacist and patient perspective.
ETHICS AND DISSEMINATION


Ethical approval was obtained from the Ethical Committee of Universitas Padjadjaran, Indonesia (No. 859/UN6.KEP/EC/2019) and all patients will provide written informed consent prior to participation. The findings of the study will be disseminated through international conferences, one or more peer-reviewed journals and reports to key stakeholders.
TRIAL REGISTRATION NUMBER


NCT04023734.",2020,"Secondary outcomes include changes in patients' blood pressure, their medication beliefs assessed by the Beliefs about Medicines Questionnaire (BMQ)-specific, as well as process characteristics of the intervention programme from a pharmacist and patient perspective.
","['10 community health centres (CHCs) in Indonesia', 'patients with type 2 diabetes in Indonesia', 'Type 2 diabetes patients aged 18 years and older who reported non-adherence to antihypertensive drugs according to the Medication Adherence Report Scale (MARS) are eligible to participate', 'patients with type 2 diabetes who are non-adherent to antihypertensive drugs in a real-world primary care Indonesian setting']","['implementing a low-cost, targeted and tailored pharmacist intervention', 'usual care based on the Indonesian guideline', 'tailored intervention based on their personal adherence barriers']","['medication adherence change', ""changes in patients' blood pressure, their medication beliefs assessed by the Beliefs about Medicines Questionnaire (BMQ)-specific, as well as process characteristics of the intervention programme from a pharmacist and patient perspective""]","[{'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0021247', 'cui_str': 'East Indies'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0457432', 'cui_str': 'Non-compliant (qualifier value)'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0222045'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0337900', 'cui_str': 'Indonesians (ethnic group)'}]","[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0337900', 'cui_str': 'Indonesians (ethnic group)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]","[{'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",,0.0954938,"Secondary outcomes include changes in patients' blood pressure, their medication beliefs assessed by the Beliefs about Medicines Questionnaire (BMQ)-specific, as well as process characteristics of the intervention programme from a pharmacist and patient perspective.
","[{'ForeName': 'Sofa D', 'Initials': 'SD', 'LastName': 'Alfian', 'Affiliation': 'Unit of Pharmaco-Therapy, -Epidemiology & -Economics, Department of Pharmacy, Groningen Research Institute of Pharmacy, University of Groningen, Groningen, The Netherlands sofa.alfian@unpad.ac.id.'}, {'ForeName': 'Rizky', 'Initials': 'R', 'LastName': 'Abdulah', 'Affiliation': 'Department of Pharmacology and Clinical Pharmacy, Faculty of Pharmacy, Universitas Padjadjaran, Jatinangor, Indonesia.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Denig', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Job F M', 'Initials': 'JFM', 'LastName': 'van Boven', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Eelko', 'Initials': 'E', 'LastName': 'Hak', 'Affiliation': 'Unit of Pharmaco-Therapy, -Epidemiology & -Economics, Department of Pharmacy, Groningen Research Institute of Pharmacy, University of Groningen, Groningen, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2019-034507']
3465,31915160,Lithium for Fracture Treatment (LiFT): a double-blind randomised control trial protocol.,"INTRODUCTION


Fracture healing can fail in up to 10% of cases despite appropriate treatment. While lithium has been the standard treatment for bipolar disorder, it may also have a significant impact to increase bone healing in patients with long bone fractures. To translate this knowledge into clinical practice, a randomised clinical trial (RCT) is proposed.
METHODS AND ANALYSIS


A multicentre double blind, placebo-controlled RCT is proposed to evaluate the efficacy of lithium to increase the rate and predictability of long bone fracture healing in healthy adults compared to lactose placebo treatment. 160 healthy individuals from 18 to 55 years of age presenting with shaft fractures of the femur, tibia/fibula, humerus or clavicle will be eligible. Fractures will be randomised to placebo (lactose) or treatment (300 mg lithium carbonate) group within 2 weeks of the injury. The primary outcome measure will be radiographic union defined as visible callus bridging on three of the four cortices at the fracture site using a validated radiographic union score. Secondary outcome measures will include functional assessment and pain scoring.
ETHICS AND DISSEMINATION


Participant confidentiality will be maintained with publication of results. Research Ethics Board Approval: Sunnybrook Research Institute (REB # 356-2016). Health Canada Approval (HC6-24-C201560). Results of the main trial and secondary endpoints will be submitted for publication in a peer-reviewed journal and presented at conferences.
TRIAL REGISTRATION NUMBER


NCT02999022.",2020,Fractures will be randomised to placebo (lactose) or treatment (300 mg lithium carbonate) group within 2 weeks of the injury.,"['160 healthy individuals from 18 to 55 years of age presenting with shaft fractures of the femur, tibia/fibula, humerus or clavicle will be eligible', 'healthy adults', 'patients with long bone fractures']","['lactose placebo', 'placebo-controlled RCT', 'lithium', 'placebo (lactose) or treatment (300\u2009mg lithium carbonate', 'Lithium']","['functional assessment and pain scoring', 'bone healing', 'rate and predictability of long bone fracture healing', 'radiographic union defined as visible callus bridging on three of the four cortices at the fracture site using a validated radiographic union score']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0337141', 'cui_str': 'Shaft (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0040184', 'cui_str': 'Tibia'}, {'cui': 'C0016068', 'cui_str': 'Fibula'}, {'cui': 'C0020164', 'cui_str': 'Humerus'}, {'cui': 'C0008913', 'cui_str': 'Clavicle'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0222647', 'cui_str': 'Structure of long bone'}]","[{'cui': 'C0022949', 'cui_str': 'Lactose'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3540800', 'cui_str': 'Lithium'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0085217', 'cui_str': 'Lithium Carbonate'}]","[{'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0222647', 'cui_str': 'Structure of long bone'}, {'cui': 'C0162542', 'cui_str': 'Fracture Healing'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205379', 'cui_str': 'Visible (qualifier value)'}, {'cui': 'C0376154', 'cui_str': 'Callosities'}, {'cui': 'C0456378', 'cui_str': 'Type of bridge (attribute)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",160.0,0.522837,Fractures will be randomised to placebo (lactose) or treatment (300 mg lithium carbonate) group within 2 weeks of the injury.,"[{'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Nam', 'Affiliation': 'Division of Orthopaedic Surgery, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada diane.nam@sunnybrook.ca.'}, {'ForeName': 'Phumeena', 'Initials': 'P', 'LastName': 'Balasuberamaniam', 'Affiliation': 'Division of Orthopaedic Surgery, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Milner', 'Affiliation': 'Division of Orthopaedic Surgery, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Kunz', 'Affiliation': 'Division of Orthopaedic Surgery, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Kathak', 'Initials': 'K', 'LastName': 'Vachhani', 'Affiliation': 'Orthopaedic Biomechanics Lab, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kiss', 'Affiliation': 'Research Design and Biostatistics, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Cari', 'Initials': 'C', 'LastName': 'Whyne', 'Affiliation': 'Orthopaedic Biomechanics Lab, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}]",BMJ open,['10.1136/bmjopen-2019-031545']
3466,31915163,Efficacy of adjunctive azithromycin versus single-dose cephalosporin prophylaxis for caesarean scar defect: study protocol for a randomised controlled trial.,"INTRODUCTION


Perioperative infections may be considered predictors of caesarean scar defect (CSD), and multidose antibiotics have a protective effect against CSD. However, the ability of adjunctive azithromycin combined with cephalosporin to reduce the prevalence of CSD remains unclear. The planned study aims to clarify the protective effect of antibiotics against CSD and to assess the effectiveness of adjunctive azithromycin prophylaxis for CSD.
METHODS AND ANALYSIS


This study is a double-blind, parallel-control randomised clinical trial that will be carried out at the International Peace Maternity and Child Health Hospital. A total of 220 eligible patients will be randomised (1:1) to receive either adjunctive azithromycin or single-dose cephalosporin 30 min before the incision. The evaluation criteria are the prevalence and characteristics of CSD as assessed by transvaginal ultrasound (TVU) and saline infusion sonohysterography (SIS) at 42 days, 6 months and 12 months after delivery. The primary outcome will be the prevalence of CSD, and the characteristics of CSD will be assessed by TVU and SIS 42 days after delivery; all other outcomes are secondary.
ETHICS AND DISSEMINATION


This protocol received authorisation from the Medical Research Ethics Committee of International Peace Maternity and Child Health Hospital on 25 April 2018 (approval no. GKLW2017-84). The findings will be reported in peer-reviewed publications and presentations at international scientific meetings.
TRIAL REGISTRATION NUMBER


ChiCTR-INR-17013272.",2020,A total of 220 eligible patients will be randomised (1:1) to receive either adjunctive azithromycin or single-dose cephalosporin 30 min before the incision.,"['International Peace Maternity and Child Health Hospital', 'caesarean scar defect', '220 eligible patients']","['adjunctive azithromycin', 'azithromycin', 'antibiotics against CSD', 'cephalosporin prophylaxis', 'azithromycin prophylaxis', 'adjunctive azithromycin or single-dose cephalosporin 30\u2009min before the incision', 'cephalosporin']","['prevalence of CSD, and the characteristics of CSD']","[{'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C4706514', 'cui_str': 'Cephalosporin product'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}]",220.0,0.334947,A total of 220 eligible patients will be randomised (1:1) to receive either adjunctive azithromycin or single-dose cephalosporin 30 min before the incision.,"[{'ForeName': 'Yanqing', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': 'Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, Shanghai, China.'}, {'ForeName': 'Hongjie', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': 'Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, Shanghai, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, Shanghai, China.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, Shanghai, China.'}, {'ForeName': 'Yiru', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, Shanghai, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zeng', 'Affiliation': 'Ultrasound, International Peace Maternity and Child Health Hospital, Shanghai, China.'}, {'ForeName': 'Liye', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Ultrasound, International Peace Maternity and Child Health Hospital, Shanghai, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, Shanghai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, Shanghai, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, Shanghai, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': 'Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, Shanghai, China.'}, {'ForeName': 'Ben W', 'Initials': 'BW', 'LastName': 'Mol', 'Affiliation': 'Obstetrics and Gynecology, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': 'Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, Shanghai, China dingding123hos@163.com.'}]",BMJ open,['10.1136/bmjopen-2019-032379']
3467,31900273,Effects of tai chi on postural control during dual-task stair negotiation in knee osteoarthritis: a randomised controlled trial protocol.,"INTRODUCTION


Stair ascent and descent require complex integration between sensory and motor systems; individuals with knee osteoarthritis (KOA) have an elevated risk for falls and fall injuries, which may be in part due to poor dynamic postural control during locomotion. Tai chi exercise has been shown to reduce fall risks in the ageing population and is recommended as one of the non-pharmocological therapies for people with KOA. However, neuromuscular mechanisms underlying the benefits of tai chi for persons with KOA are not clearly understood. Postural control deficits in performing a primary motor task may be more pronounced when required to simultaneously attend to a cognitive task. This single-blind, parallel design randomised controlled trial (RCT) aims to evaluate the effects of a 12-week tai chi programme versus balance and postural control training on neuromechanical characteristics during dual-task stair negotiation.
METHODS AND ANALYSIS


Sixty-six participants with KOA will be randomised into either tai chi or balance and postural control training, each at 60 min per session, twice weekly for 12 weeks. Assessed at baseline and 12 weeks (ie, postintervention), the primary outcomes are attention cost and dynamic postural stability during dual-task stair negotiation. Secondary outcomes include balance and proprioception, foot clearances, self-reported symptoms and function. A telephone follow-up to assess symptoms and function will be conducted at 20 weeks. The findings will help determine whether tai chi is beneficial on dynamic stability and in reducing fall risks in older adults with KOA patients in community.
ETHICS AND DISSEMINATION


Ethics approval was obtained from the Ethics Committee of the Affiliated Rehabilitation Hospital of Fujian University of Traditional Chinese Medicine (#2018KY-006-1). Study findings will be disseminated through presentations at scientific conferences or publications in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


ChiCTR1800018028.",2020,Assessed at baseline and 12 weeks,"['people with KOA', 'Sixty-six participants with KOA', 'persons with KOA', 'individuals with knee osteoarthritis (KOA', 'older adults with KOA patients in community', 'Ethics approval was obtained from the Ethics Committee of the Affiliated Rehabilitation Hospital of Fujian University of Traditional Chinese Medicine (#2018KY-006-1', 'knee osteoarthritis']","['Tai chi exercise', 'tai chi programme versus balance and postural control training', 'dual-task stair negotiation', 'tai chi', 'tai chi or balance and postural control training', 'Stair ascent and descent require complex integration between sensory and motor systems']","['balance and proprioception, foot clearances, self-reported symptoms and function', 'attention cost and dynamic postural stability during dual-task stair negotiation']","[{'cui': 'C4517841', 'cui_str': 'Sixty-six'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0085546', 'cui_str': 'Ethics Committees'}, {'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0025124', 'cui_str': 'Zhong Yi Xue'}]","[{'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0680727', 'cui_str': 'Negotiation'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0680727', 'cui_str': 'Negotiation'}]",66.0,0.108125,Assessed at baseline and 12 weeks,"[{'ForeName': 'Xiangbin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Meijin', 'Initials': 'M', 'LastName': 'Hou', 'Affiliation': 'Key Laboratory of Orthopedics & Traumatology of Traditional Chinese Medicine and Rehabilitation (FuJian University of Traditional Chinese Medicine), Ministry of Education, Fuzhou, China.'}, {'ForeName': 'Shaoqing', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Dalu', 'Initials': 'D', 'LastName': 'Qi', 'Affiliation': 'College of Sports, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Yanxin', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Sport and Exercise Science, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xiong', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Shengxing', 'Initials': 'S', 'LastName': 'Fu', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Zhenhui', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Fengjiao', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Chang', 'Affiliation': 'Department of Physical Therapy and Human Movement Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Anmin', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'School of Health and Society, University of Salford, Salford, UK.'}, {'ForeName': 'Xuerong', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': ""Rehabilitation Department of the Affiliated 3rd Peoples' Hospital, Fujian University of Traditional Chinese Medicine, Fuzhou, China 384098067@qq.com.""}]",BMJ open,['10.1136/bmjopen-2019-033230']
3468,31911516,Study protocol for the road to hierarchical diabetes management at primary care (ROADMAP) study in China: a cluster randomised controlled trial.,"INTRODUCTION


Diabetes management in primary care remains suboptimal in China, despite its inclusion in the essential public health service (EPHS). We aimed to evaluate the effectiveness of a mobile health (mHealth) based and three-tiered diabetes management system in diverse Chinese contexts.
METHODS AND ANALYSIS


This is a cluster randomised controlled trial, named road to hierarchical diabetes management at primary care (ROADMAP). 19 008 patients with type 2 diabetes (T2D) were recruited from primary care clinics in 864 communities across 144 counties/districts of 24 provinces. Eligible participants were adult patients diagnosed with T2D and registered for diabetes management in communities. Patients within the same communities (clusters) were randomly allocated into the intervention or control arm for 1 year in a 2:1 ratio. The control arm patients received usual care as EPHS packaged: at least four blood glucose (BG) and blood pressure (BP) tests, and lifestyle and medication instruction, yearly, from primary care providers. The intervention arm patients received at least two BG and one BP tests, monthly, and lifestyle and treatment instruction from a three-tiered contracted team. A mHealth platform,  Graded ROADMAP,  enabled test results uploading and sharing, and patient referral within the team. The intervention participants will be further divided into basic or intensive intervention group according to whether they were actively using the  Your Doctor  App. The primary outcome is the BG control rate with glycated haemoglobin (HbA1c)<7.0%. Secondary outcomes include control rates and changes of ABC (HbA1c, BP and low-density lipoprotein cholesterol) and fasting BG, hypoglycaemia episodes and health-related quality of life (EuroQol (EQ-5D)).
ETHICS AND DISSEMINATION


The trial has been approved by the Institutional Review Board at Shanghai Sixth People's Hospital. Findings on the intervention effectiveness will be disseminated through peer-reviewed journals, conference presentations and other relevant mechanisms.
TRIAL REGISTRATION NUMBER


ChiCTR-IOC-17011325.",2020,"Secondary outcomes include control rates and changes of ABC (HbA1c, BP and low-density lipoprotein cholesterol) and fasting BG, hypoglycaemia episodes and health-related quality of life (EuroQol (EQ-5D)).
","['road to hierarchical diabetes management at primary care (ROADMAP) study in China', 'diverse Chinese contexts', 'Patients within the same communities (clusters', 'Eligible participants were adult patients diagnosed with T2D and registered for diabetes management in communities', '19\u2009008 patients with type 2 diabetes (T2D) were recruited from primary care clinics in 864 communities across 144 counties/districts of 24 provinces']","['usual care as EPHS packaged: at least four blood glucose (BG) and blood pressure (BP) tests, and lifestyle and medication instruction, yearly, from primary care providers', 'mobile health (mHealth) based and three-tiered diabetes management system']","['BG control rate with glycated haemoglobin', 'control rates and changes of ABC (HbA1c, BP and low-density lipoprotein cholesterol) and fasting BG, hypoglycaemia episodes and health-related quality of life (EuroQol (EQ-5D']","[{'cui': 'C0442650', 'cui_str': 'Road (environment)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}]","[{'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider (occupation)'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}]",,0.151849,"Secondary outcomes include control rates and changes of ABC (HbA1c, BP and low-density lipoprotein cholesterol) and fasting BG, hypoglycaemia episodes and health-related quality of life (EuroQol (EQ-5D)).
","[{'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Jia', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiaotong University Affiliated Sixth People's Hospital, Shanghai, China wpjia@sjtu.edu.cn.""}, {'ForeName': 'Puhong', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Diabetes Group, The George Institute at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Nadila', 'Initials': 'N', 'LastName': 'Duolikun', 'Affiliation': 'Diabetes Group, The George Institute at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Dalong', 'Initials': 'D', 'LastName': 'Zhu', 'Affiliation': 'Department of Endocrinology, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Yuqian', 'Initials': 'Y', 'LastName': 'Bao', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiaotong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'School of Computing, Beihang University, Beijing, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-032734']
3469,31915170,Rationale and design of the Web-basEd soCial media tecHnology to improvement in Adherence to dual anTiplatelet Therapy following Drug-Eluting Stent Implantation (WECHAT): protocol for a randomised controlled study.,"BACKGROUND


Dual antiplatelet therapy (DAPT) is frequently discontinued after drug-eluting stent (DES) implantation, which could increase the risk of major adverse cardiovascular events (MACEs). Few studies have attempted to improve DAPT adherence through web-based social media.
OBJECTIVE


To explore the effect of social media on DAPT adherence following DES implantation.
METHODS/DESIGN


The WeChat trial is a multicentre, single-blind, randomised study (1:1). It will recruit 760 patients with DES who require 12 months of DAPT. The control group will only receive usual care and general educational messages on medical knowledge. The intervention group will receive a personalised intervention, including interactive responses and medication and follow-up reminders beyond the general educational messages. The primary endpoint will be the discontinuation rate which is defined as the cessation of any dual antiplatelet drug owing to the participants' discretion within 1 year of DES implantation. The secondary endpoints will include medication adherence and MACEs. Both groups will receive messages or reminders four times a week with follow-ups over 12 months.
ETHICS AND DISSEMINATION


Ethical approval was granted by Ethics Committee of Guangdong Provincial People's Hospital (GDREC2018327H). Results will be disseminated via peer-reviewed publications and presentations at international conferences.
TRIAL REGISTRATION NUMBER


NCT03732066.",2020,"The intervention group will receive a personalised intervention, including interactive responses and medication and follow-up reminders beyond the general educational messages.",['760 patients with DES who require 12 months of DAPT'],"['personalised intervention, including interactive responses and medication and follow-up reminders beyond the general educational messages', 'social media', 'usual care and general educational messages on medical knowledge', 'antiplatelet therapy (DAPT']","['DAPT adherence', 'medication adherence and MACEs', ""discontinuation rate which is defined as the cessation of any dual antiplatelet drug owing to the participants' discretion within 1\u2009year of DES implantation""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]","[{'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0085826', 'cui_str': 'Antiplatelet Agents'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]",760.0,0.11816,"The intervention group will receive a personalised intervention, including interactive responses and medication and follow-up reminders beyond the general educational messages.","[{'ForeName': 'Guo-Li', 'Initials': 'GL', 'LastName': 'Sun', 'Affiliation': ""Department of Cardiology, Guangdong Provincial People's Hospital affiliated with South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Lei', 'Affiliation': ""Department of Cardiology, Guangdong Provincial People's Hospital affiliated with South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Liwei', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, Guangdong Provincial People's Hospital affiliated with South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, Guangdong Provincial People's Hospital affiliated with South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Yibo', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': ""Department of Cardiology, Guangdong Provincial People's Hospital affiliated with South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Zhaodong', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': ""Department of Cardiology, Guangdong Provincial People's Hospital affiliated with South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Xiaohua', 'Initials': 'X', 'LastName': 'Dai', 'Affiliation': 'School of Pharmacy, Guangdong Pharmaceutical University, Guangzhou, China.'}, {'ForeName': 'Lihao', 'Initials': 'L', 'LastName': 'He', 'Affiliation': ""Department of Cardiology, Guangdong Provincial People's Hospital affiliated with South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Shi-Qun', 'Initials': 'SQ', 'LastName': 'Chen', 'Affiliation': ""Department of Cardiology, Guangdong Provincial People's Hospital affiliated with South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Department of Cardiology, Maoming General Hospital, Guangzhou, China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': ""Department of Cardiology, Dongguan People's Hospital, Dongguan, China.""}, {'ForeName': 'Yunzhao', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': ""Department of Cardiology, First People's Hospital, Shunde, China.""}, {'ForeName': 'Guoqin', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Guangzhou Panyu Central Hospital, Guangzhou, China.'}, {'ForeName': 'Ji-Yan', 'Initials': 'JY', 'LastName': 'Chen', 'Affiliation': ""Department of Cardiology, Guangdong Provincial People's Hospital affiliated with South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, Guangdong Provincial People's Hospital affiliated with South China University of Technology, Guangzhou, China liuyong2099@126.com.""}]",BMJ open,['10.1136/bmjopen-2019-033017']
3470,31915173,"Adjusting Early Warning Score by clinical assessment: a study protocol for a Danish cluster-randomised, multicentre study of an Individual Early Warning Score (I-EWS).","INTRODUCTION


Track and trigger systems (TTSs) based on vital signs are implemented in hospitals worldwide to identify patients with clinical deterioration. TTSs may provide prognostic information but do not actively include clinical assessment, and their impact on severe adverse events remain uncertain. The demand for prospective, multicentre studies to demonstrate the effectiveness of TTSs has grown the last decade. Individual Early Warning Score (I-EWS) is a newly developed TTS with an aggregated score based on vital signs that can be adjusted according to the clinical assessment of the patient. The objective is to compare I-EWS with the existing National Early Warning Score (NEWS) algorithm regarding clinical outcomes and use of resources.
METHOD AND ANALYSIS


In a prospective, multicentre, cluster-randomised, crossover, non-inferiority study. Eight hospitals are randomised to use either NEWS in combination with the Capital Region of Denmark NEWS Override System (CROS) or implement I-EWS for 6.5 months, followed by a crossover. Based on their clinical assessment, the nursing staff can adjust the aggregated score with a maximum of -4 or +6 points. We expect to include 150 000 unique patients. The primary endpoint is all-cause mortality at 30 days. Coprimary endpoint is the average number of times per day a patient is NEWS/I-EWS-scored, and secondary outcomes are all-cause mortality at 48 hours and at 7 days as well as length of stay.
ETHICS AND DISSEMINATION


The study was presented for the Regional Ethics committee who decided that no formal approval was needed according to Danish law (J.no. 1701733). The I-EWS study is a large prospective, randomised multicentre study that investigates the effect of integrating a clinical assessment performed by the nursing staff in a TTS, in a head-to-head comparison with the internationally used NEWS with the opportunity to use CROS.
TRIAL REGISTRATION NUMBER


NCT03690128.",2020,Individual Early Warning Score (I-EWS) is a newly developed TTS with an aggregated score based on vital signs that can be adjusted according to the clinical assessment of the patient.,"['150 000 unique patients', 'patients with clinical deterioration']","['NEWS in combination with the Capital Region of Denmark NEWS Override System', 'TTSs', 'Track and trigger systems (TTSs']","['average number of times per day a patient is NEWS', 'length of stay', 'cause mortality']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4505323', 'cui_str': 'Clinical Deterioration'}]","[{'cui': 'C0282425', 'cui_str': 'News'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}]","[{'cui': 'C0449809', 'cui_str': 'Number of times (qualifier value)'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0282425', 'cui_str': 'News'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.070485,Individual Early Warning Score (I-EWS) is a newly developed TTS with an aggregated score based on vital signs that can be adjusted according to the clinical assessment of the patient.,"[{'ForeName': 'Pernille B', 'Initials': 'PB', 'LastName': 'Nielsen', 'Affiliation': 'Department of Emergency Medicine, Herlev-Gentofte Hospital, University of Copenhagen, Herlev, Denmark pernille.brok.nielsen@regionh.dk.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schultz', 'Affiliation': 'Department of Emergency Medicine, Herlev-Gentofte Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Caroline Sophie', 'Initials': 'CS', 'LastName': 'Langkjaer', 'Affiliation': 'Department of Emergency Medicine, Nordsjaellands Hospital, Hillerod, Denmark.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Kodal', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Nordsjaellands Hospital, Hillerod, Denmark.'}, {'ForeName': 'Niels Egholm', 'Initials': 'NE', 'LastName': 'Pedersen', 'Affiliation': 'Department of Anaesthesia, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'John Asger', 'Initials': 'JA', 'LastName': 'Petersen', 'Affiliation': 'Department of Day Surgery, Amager and Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark.'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'Department of Public Health, Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Michael Dan', 'Initials': 'MD', 'LastName': 'Arvig', 'Affiliation': 'Department of Emergency Medicine, Slagelse Hospital, Slagelse, Denmark.'}, {'ForeName': 'Christian Sahlholt', 'Initials': 'CS', 'LastName': 'Meyhoff', 'Affiliation': 'Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Bestle', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Nordsjaellands Hospital, Hillerod, Denmark.'}, {'ForeName': 'Bibi', 'Initials': 'B', 'LastName': 'Hølge-Hazelton', 'Affiliation': 'Research Support Unit, Zealand University Hospital Roskilde, Roskilde, Denmark.'}, {'ForeName': 'Gitte', 'Initials': 'G', 'LastName': 'Bunkenborg', 'Affiliation': 'Department of Anesthesiology, Holbaek Hospital, Holbaek, Denmark.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Lippert', 'Affiliation': 'Copenhagen Academy for Medical Education and Simulation, Herlev, Denmark.'}, {'ForeName': 'Ove', 'Initials': 'O', 'LastName': 'Andersen', 'Affiliation': 'Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lars Simon', 'Initials': 'LS', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Anaesthesia, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Kasper Karmark', 'Initials': 'KK', 'LastName': 'Iversen', 'Affiliation': 'Department of Emergency Medicine, Herlev-Gentofte Hospital, University of Copenhagen, Herlev, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-033676']
3471,31718842,Spectral-Domain OCT-Based Prevalence and Progression of Macular Atrophy in the HARBOR Study for Neovascular Age-Related Macular Degeneration.,"PURPOSE


Previous studies of macular atrophy (MA) in HARBOR analyzed color fundus photography and fluorescein angiography image data. This study performed a longitudinal assessment of monthly spectral-domain (SD) OCT scans to determine MA prevalence, incidence, and progression in HARBOR.
DESIGN


Post hoc analysis of SD OCT images from HARBOR (ClincalTrials.gov identifier, NCT00891735), a phase 3 multicenter, prospective, randomized, double-blind, active treatment-controlled clinical trial.
PARTICIPANTS


Patients (n = 1097) with subfoveal choroidal neovascularization secondary to neovascular age-related macular degeneration (nAMD) treated with ranibizumab 0.5 mg monthly (n = 275), 0.5 mg pro re nata (PRN) after 3 loading doses (n = 275), 2.0 mg monthly (n = 274), or 2.0 mg PRN (n = 273).
METHODS


Evaluable SD OCT macular cube scans from patients with 24 months of follow-up (N = 941) were examined by masked reading center-trained graders monthly from baseline to month 24. Atrophy diagnosis criteria were consistent with those proposed by the Classification of Atrophy Meetings (CAM) group: hypertransmission of light into the choroid, retinal pigment epithelium loss, and loss of outer retinal layers. Macular atrophy was considered Definite if all 3 criteria were met and Questionable if 2 were met. Study arms were compared for time to MA detection (log-rank test) and enlargement rates (time × arm interaction test).
MAIN OUTCOME MEASURES


Prevalence, incidence, and enlargement rates of MA.
RESULTS


At baseline, imbalance in MA rates across ranibizumab arms was evident (0.5 mg monthly, 19.1%; 0.5 mg PRN, 16.1%; 2.0 mg monthly, 10.1%; 2.0 mg PRN, 10.5%). At month 24, new MA development rates in eyes without baseline MA were similar between ranibizumab doses (0.5 mg, 25.9%; 2.0 mg, 25.4%) and treatment regimens (monthly, 26.4%; PRN, 25.0%). No significant differences in enlargement rate of new atrophy area (P = 0.479, square-root transformed) or time to detection of new MA (P = 0.997) were evident among study arms.
CONCLUSIONS


In this analysis of a major nAMD trial using CAM atrophy criteria, no differences were observed in incidence or progression rates of new MA among study arms, ranibizumab doses, or treatment regimens. Monthly versus PRN treatment did not influence MA incidence or progression.",2020,"No significant differences in enlargement rate of new atrophy area (P = 0.479, square-root transformed) or time to detection of new MA (P = 0.997) were evident among study arms.
","['Evaluable SD-OCT macular cube scans from patients with 24 months of follow-up', 'Patients (n\xa0= 1097) with subfoveal choroidal neovascularization secondary to neovascular age-related macular degeneration (nAMD) treated with']","['ranibizumab', 'monthly spectral-domain (SD) OCT scans', 'ranibizumab 0.5 mg monthly (n\xa0= 275), 0.5 mg pro re nata (PRN']","['Macular atrophy', 'enlargement rate of new atrophy area', 'MA incidence or progression', 'Prevalence, incidence, and enlargement rates of MA', 'new MA development rates', 'time to MA detection (log-rank test) and enlargement rates (time\xa0× arm interaction test', 'MA rates']","[{'cui': 'C0441633'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0442185', 'cui_str': 'Subfoveal (qualifier value)'}, {'cui': 'C0600518', 'cui_str': 'Neovascularization, Choroid'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0441633'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0067792', 'cui_str': 'NATA'}, {'cui': 'C0558288', 'cui_str': 'prn'}]","[{'cui': 'C1288283', 'cui_str': 'Anetoderma'}, {'cui': 'C1293134', 'cui_str': 'Enlargement procedure'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0699794', 'cui_str': 'Rank (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]",1097.0,0.142077,"No significant differences in enlargement rate of new atrophy area (P = 0.479, square-root transformed) or time to detection of new MA (P = 0.997) were evident among study arms.
","[{'ForeName': 'Shamika', 'Initials': 'S', 'LastName': 'Gune', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Nizar Saleh', 'Initials': 'NS', 'LastName': 'Abdelfattah', 'Affiliation': 'Doheny Eye Institute, Los Angeles, California; Department of Ophthalmology, David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Ayesha', 'Initials': 'A', 'LastName': 'Karamat', 'Affiliation': 'Doheny Eye Institute, Los Angeles, California.'}, {'ForeName': 'Siva', 'Initials': 'S', 'LastName': 'Balasubramanian', 'Affiliation': 'Doheny Eye Institute, Los Angeles, California.'}, {'ForeName': 'Kenneth M', 'Initials': 'KM', 'LastName': 'Marion', 'Affiliation': 'Doheny Eye Institute, Los Angeles, California.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Morgenthien', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'SriniVas R', 'Initials': 'SR', 'LastName': 'Sadda', 'Affiliation': 'Doheny Eye Institute, Los Angeles, California; Department of Ophthalmology, David Geffen School of Medicine at UCLA, Los Angeles, California. Electronic address: ssadda@doheny.org.'}]",Ophthalmology,['10.1016/j.ophtha.2019.09.030']
3472,32134977,Heterogeneous treatment effects of a text messaging smoking cessation intervention among university students.,"INTRODUCTION


Despite tobacco being an important preventable factor with respect to ill health and death, it is a legal substance that harms and kills many of those who use it. Text messaging smoking cessation interventions have been evaluated in a variety of contexts, and are generally considered to have a positive effect on smoking cessation success. In order for text messaging interventions to continue to be useful as prevalence of smoking decreases, it may be necessary to tailor the interventions to specific individuals. However, little is known with regard to who benefits the most and least from existing interventions.
METHODS


In order to identify heterogenous treatment effects, we analyzed data from a randomized controlled trial of a text messaging smoking cessation intervention targeting university students in Sweden. We used a Bayesian hierarchical model where the outcome was modelled using logistic regression, and so-called horseshoe priors were used for coefficients. Predictive performance of the model, and heterogeneous treatment effects, were calculated using cross-validation over the trial data.
RESULTS


Findings from the study of heterogenous treatment effects identified less effect of the intervention among university students with stronger dependence of nicotine and students who smoke a greater quantity of cigarettes per week. No heterogeneity was found with respect to sex, number of years smoking, or the use of snuff.
DISCUSSION


Results emphasize that individuals with a more developed dependence of nicotine may have a harder time quitting smoking even with support. This questions the dissemination and development of text messaging interventions to university students in the future, as they may not be the optimal choice of intervention for those with a more developed dependence. On the other hand, text messaging interventions may be useful to disseminate among university students that are at risk of developing a strong dependence.
TRIAL REGISTRATION


International Standard Randomized Controlled Trial Number (ISRCTN): 75766527; http://www.controlled-trials.com/ISRCTN75766527.",2020,"RESULTS


Findings from the study of heterogenous treatment effects identified less effect of the intervention among university students with stronger dependence of nicotine and students who smoke a greater quantity of cigarettes per week.","['targeting university students in Sweden', 'university students']",['text messaging smoking cessation intervention'],[],"[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]",[],,0.0621369,"RESULTS


Findings from the study of heterogenous treatment effects identified less effect of the intervention among university students with stronger dependence of nicotine and students who smoke a greater quantity of cigarettes per week.","[{'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Bendtsen', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.'}]",PloS one,['10.1371/journal.pone.0229637']
3473,32182274,Prevalence and risk factors for latent tuberculosis infection among household contacts of index cases in two South African provinces: Analysis of baseline data from a cluster-randomised trial.,"INTRODUCTION


Household contacts of patients with active pulmonary tuberculosis (TB) often have latent TB infection, and are at risk of progression to disease. We set out to investigate whether index TB case HIV status was linked to a higher probability of latent TB infection among household contacts.
MATERIALS AND METHODS


Data were collected prospectively from participants in the intervention arm of a household cluster-randomised trial in two South Africa provinces (Mangaung, Free State, and Capricorn, Limpopo). In intervention group households, TB contacts underwent HIV testing and tuberculin skin testing (TST). TST induration was estimated at two cut-offs (≥5mm, ≥10mm). Multilevel Bayesian regression models estimated posterior distributions of the percentage of household contacts with TST induration ≥5mm and ≥10mm by age group, and compared the odds of latent TB infection by key risk factors including HIV status index case age and study province.
RESULTS


A total of 2,985 household contacts of 924 index cases were assessed, with most 2,725 (91.3%) undergoing TST. HIV prevalence in household contacts was 14% and 10% in Mangaung and Capricorn respectively. Overall, 16.8% (458/2,725) had TST induration of ≥5mm and 13.1% (359/2,725) ≥10mm. In Mangaung, children aged 0-4 years had a high TST positivity prevalence compared to their peers in Capricorn (22.0% vs. 7.6%, and 20.5% vs. 2.3%, using TST thresholds of ≥5mm and ≥10mm respectively). Compared to contacts from Capricorn, household contacts living in Mangaung were more likely to have TST induration ≥5mm (odds ratio [OR]: 3.08, 95% credibility interval [CI]: 2.13-4.58) and ≥10mm (OR: 4.52, 95% CI: 3.03-6.97). There was a 90% and 92% posterior probability that the odds of TST induration ≥5mm (OR: 0.79, 95% CI: 0.56-1.14) and ≥10mm (OR: 0.77, 95% CI: 0.53-1.10) respectively were lower in household contacts of HIV-positive compared to HIV-negative index cases.
CONCLUSIONS


High TST induration positivity, especially among young children and people living in Mangaung indicates considerable TB transmission despite high antiretroviral therapy coverage. Household contact of HIV-positive index TB cases were less likely to have evidence of latent TB infection than contacts of HIV-negative index cases.",2020,Household contact of HIV-positive index TB cases were less likely to have evidence of latent TB infection than contacts of HIV-negative index cases.,"['patients with active pulmonary tuberculosis (TB', 'Data were collected prospectively from participants in the intervention arm of a household cluster-randomised trial in two South Africa provinces (Mangaung, Free State, and Capricorn, Limpopo', 'household contacts of index cases in two South African provinces']",['HIV testing and tuberculin skin testing (TST'],"['TST induration', 'TST positivity prevalence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary Phthisis'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0041289', 'cui_str': 'Tuberculin'}, {'cui': 'C1123023', 'cui_str': 'Skin'}]","[{'cui': 'C0332534', 'cui_str': 'Induration (morphologic abnormality)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",2.0,0.214704,Household contact of HIV-positive index TB cases were less likely to have evidence of latent TB infection than contacts of HIV-negative index cases.,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'MacPherson', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, England, United Kingdom.'}, {'ForeName': 'Limakatso', 'Initials': 'L', 'LastName': 'Lebina', 'Affiliation': 'SA MRC Soweto Matlosana Collaborating Centre for HIV/AIDS and TB, Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Kegaugetswe', 'Initials': 'K', 'LastName': 'Motsomi', 'Affiliation': 'SA MRC Soweto Matlosana Collaborating Centre for HIV/AIDS and TB, Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Zama', 'Initials': 'Z', 'LastName': 'Bosch', 'Affiliation': 'SA MRC Soweto Matlosana Collaborating Centre for HIV/AIDS and TB, Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Minja', 'Initials': 'M', 'LastName': 'Milovanovic', 'Affiliation': 'SA MRC Soweto Matlosana Collaborating Centre for HIV/AIDS and TB, Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ratsela', 'Affiliation': 'Department of Internal Medicine, University of Limpopo, and Limpopo Department of Health, Polokwane, South Africa.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Lala', 'Affiliation': 'Department of Paediatrics and Child Health, Chris Hani Baragwanath Academic Hospital and University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Variava', 'Affiliation': 'Department of Internal Medicine, Klerksdorp Tshepong Hospital Complex, North West Department of Health and University of the Witwatersrand, Polokwane, South Africa.'}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Golub', 'Affiliation': 'Johns Hopkins University Center for TB Research, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Webb', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, England, United Kingdom.'}, {'ForeName': 'Neil A', 'Initials': 'NA', 'LastName': 'Martinson', 'Affiliation': 'Department of Paediatrics and Child Health, Chris Hani Baragwanath Academic Hospital and University of the Witwatersrand, Johannesburg, South Africa.'}]",PloS one,['10.1371/journal.pone.0230376']
3474,32005561,Efficacy of Repeat Selective Laser Trabeculoplasty in Medication-Naive Open-Angle Glaucoma and Ocular Hypertension during the LiGHT Trial.,"PURPOSE


To determine the efficacy of repeat selective laser trabeculoplasty (SLT) in medication-naive open-angle glaucoma (OAG) and ocular hypertensive (OHT) patients requiring repeat treatment for early to medium-term failure during the Laser in Glaucoma and Ocular Hypertension (LiGHT) trial.
DESIGN


Post hoc analysis of SLT treatment arm of a multicenter prospective randomized controlled trial.
PARTICIPANTS


Treatment-naive OAG or OHT requiring repeat 360-degree SLT within 18 months. Retreatment was triggered by predefined IOP and disease-progression criteria (using objective individualized target IOPs).
METHODS


After SLT at baseline, patients were followed for a minimum of 18 months after second (repeat) SLT. A mixed-model analysis was performed with the eye as the unit of analysis, with crossed random effects to adjust for correlation between fellow eyes and repeated measures within eyes. Kaplan-Meier curves plot the duration of effect.
MAIN OUTCOME MEASURES


Initial (early) IOP lowering at 2 months and duration of effect after initial and repeat SLT.
RESULTS


A total of 115 eyes of 90 patients received repeat SLT during the first 18 months of the trial. Pretreatment IOP before initial SLT was significantly higher than before retreatment IOP of repeat SLT (mean difference, 3.4 mmHg; 95% confidence interval [CI], 2.6-4.3 mmHg; P < 0.001). Absolute IOP reduction at 2 months was greater after initial SLT compared with repeat SLT (mean difference, 1.0 mmHg; 95% CI, 0.2-1.8 mmHg; P = 0.02). Adjusted absolute IOP reduction at 2 months (adjusting for IOP before initial or repeat laser) was greater after repeat SLT (adjusted mean difference, -1.1 mmHg, 95% CI, -1.7 to -0.5 mmHg; P = 0.001). A total of 34 eyes were early failures (retreatment 2 months after initial SLT) versus 81 later failures (retreatment >2 months after initial SLT). No significant difference in early absolute IOP reduction at 2 months after repeat SLT was noted between early and later failures (mean difference, 0.3 mmHg; 95% CI, -1.1 to 1.8 mmHg; P = 0.655). Repeat SLT maintained drop-free IOP control in 67% of 115 eyes at 18 months, with no clinically relevant adverse events.
CONCLUSIONS


These exploratory analyses demonstrate that repeat SLT can maintain IOP at or below target IOP in medication-naive OAG and OHT eyes requiring retreatment with at least an equivalent duration of effect to initial laser.",2020,"Adjusted absolute IOP reduction at 2 months (adjusting for IOP before initial or repeat laser) was greater after repeat SLT (adjusted mean difference, -1.1 mmHg, 95% CI, -1.7 to -0.5 mmHg; P = 0.001).","['Treatment-naive OAG or OHT requiring repeat 360-degree SLT within 18 months', 'A total of 115 eyes of 90 patients received', 'medication-naive open-angle glaucoma (OAG) and ocular hypertensive (OHT) patients requiring repeat treatment for early to medium-term failure during the Laser in Glaucoma and Ocular Hypertension (LiGHT) trial']","['Repeat Selective Laser Trabeculoplasty', 'repeat selective laser trabeculoplasty (SLT', 'repeat SLT']","['early absolute IOP reduction', 'Adjusted absolute IOP reduction', 'Initial (early) IOP lowering at 2 months and duration of effect after initial and repeat SLT', 'Repeat SLT maintained drop-free IOP control', 'Absolute IOP reduction']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017612', 'cui_str': 'Glaucoma, Compensated'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0851409', 'cui_str': 'Glaucoma and ocular hypertension'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1271447', 'cui_str': 'SLT - selective laser trabeculoplasty'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",34.0,0.108816,"Adjusted absolute IOP reduction at 2 months (adjusting for IOP before initial or repeat laser) was greater after repeat SLT (adjusted mean difference, -1.1 mmHg, 95% CI, -1.7 to -0.5 mmHg; P = 0.001).","[{'ForeName': 'Anurag', 'Initials': 'A', 'LastName': 'Garg', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Vickerstaff', 'Affiliation': 'Marie Curie Palliative Care Research Department, UCL Division of Psychiatry, University College London, London, United Kingdom; The Research Department of Primary Care and Population Health, University College London, London, United Kingdom.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Nathwani', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Garway-Heath', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom.'}, {'ForeName': 'Evgenia', 'Initials': 'E', 'LastName': 'Konstantakopoulou', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Ambler', 'Affiliation': 'Department of Statistical Science, University College London, London, United Kingdom.'}, {'ForeName': 'Catey', 'Initials': 'C', 'LastName': 'Bunce', 'Affiliation': ""NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom; School of Population Health and Environmental Sciences, Faculty of Life Sciences and Medicine, King's College London, London, United Kingdom; London School of Hygiene and Tropical Medicine, London, United Kingdom.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Wormald', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom; London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Barton', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom.'}, {'ForeName': 'Gus', 'Initials': 'G', 'LastName': 'Gazzard', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom. Electronic address: gusgazzard@gmail.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2019.10.023']
3475,32001003,Long-term effectiveness of two models of brief psychotherapy for depression: A three-year follow-up randomized clinical trial.,"Major depressive disorder (MDD) is a disease that severely impairs psychosocial functioning and decreases the subject's quality of life. Patients who received psychotherapy have a better long-term therapeutic response than those who have only been treated with antidepressants or have not been treated. There are few studies in the literature that follow the outcomes of psychotherapeutic treatments for depression for more than two years. The aim of this study is to compare the therapeutic response of two models of brief psychotherapy for MDD treatment (Cognitive Behavioral Therapy and Short-term Psychodynamic Psychotherapy) with naturalistic controls who received treatment as usual in a three-year follow-up. This is a sample of 75 outpatients, mostly women (82.7%), with a median age of 33 (27-44). The interventions took place in 50-minute sessions once a week for 14 to 16 weeks. Outcomes were assessed at baseline and three years after the intervention. Regarding depressive symptoms, the therapeutic response was maintained three years after the conclusion of the brief models of psychotherapy. Functional capacity long-term maintenance depended not only on the intervention but also on the education level, the work situation and the severity of depressive symptoms at the beginning of the treatment.",2020,Patients who received psychotherapy have a better long-term therapeutic response than those who have only been treated with antidepressants or have not been treated.,"['75 outpatients, mostly women (82.7%), with a median age of 33 (27-44', 'Major depressive disorder (MDD', 'depression']","['psychotherapy for MDD treatment (Cognitive Behavioral Therapy and Short-term Psychodynamic Psychotherapy', 'psychotherapy']","['severity of depressive symptoms', 'Functional capacity long-term maintenance', 'better long-term therapeutic response']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1261382', 'cui_str': 'Psychotherapy, Psychodynamic'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0521982', 'cui_str': 'Therapeutic response, function (observable entity)'}]",75.0,0.0368115,Patients who received psychotherapy have a better long-term therapeutic response than those who have only been treated with antidepressants or have not been treated.,"[{'ForeName': 'Érico Nobre', 'Initials': 'ÉN', 'LastName': 'Dos Santos', 'Affiliation': 'Programa de Pós-Graduação em Saúde e Comportamento, Universidade Católica de Pelotas (UCPel), Rua Gonçalves Chaves, 373, sala 424 C, Pelotas 96015-560 RS, Brazil. Electronic address: ericons@gmail.com.'}, {'ForeName': 'Mariane Lopez', 'Initials': 'ML', 'LastName': 'Molina', 'Affiliation': 'Programa de Pós-Graduação em Saúde e Comportamento, Universidade Católica de Pelotas (UCPel), Rua Gonçalves Chaves, 373, sala 424 C, Pelotas 96015-560 RS, Brazil; Faculdade Anhanguera do Rio Grande, Av. Rheingantz, 91 - Pq. Residencial Coelho, Rio Grande 96202-110 RS, Brazil.'}, {'ForeName': 'Thaise', 'Initials': 'T', 'LastName': 'Mondin', 'Affiliation': 'Programa de Pós-Graduação em Saúde e Comportamento, Universidade Católica de Pelotas (UCPel), Rua Gonçalves Chaves, 373, sala 424 C, Pelotas 96015-560 RS, Brazil; Pró-Reitoria de Assuntos Estudantis - Universidade Federal de Pelotas (UFPel), Rua Almirante Barroso, 1202, Centro, Pelotas 96010-280 RS, Brazil.'}, {'ForeName': 'Taiane de Azevedo', 'Initials': 'TA', 'LastName': 'Cardoso', 'Affiliation': 'Programa de Pós-Graduação em Saúde e Comportamento, Universidade Católica de Pelotas (UCPel), Rua Gonçalves Chaves, 373, sala 424 C, Pelotas 96015-560 RS, Brazil; Department of Psychiatry and Behavioural Neurosciences, McMaster University, 100 West 5th Street, Research Office G110 ON L8N 3K7 Hamilton, Canada.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Silva', 'Affiliation': 'Programa de Pós-Graduação em Saúde e Comportamento, Universidade Católica de Pelotas (UCPel), Rua Gonçalves Chaves, 373, sala 424 C, Pelotas 96015-560 RS, Brazil.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Souza', 'Affiliation': 'Programa de Pós-Graduação em Saúde e Comportamento, Universidade Católica de Pelotas (UCPel), Rua Gonçalves Chaves, 373, sala 424 C, Pelotas 96015-560 RS, Brazil.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Jansen', 'Affiliation': 'Programa de Pós-Graduação em Saúde e Comportamento, Universidade Católica de Pelotas (UCPel), Rua Gonçalves Chaves, 373, sala 424 C, Pelotas 96015-560 RS, Brazil.'}]",Psychiatry research,['10.1016/j.psychres.2020.112804']
3476,32150584,A simulation based difficult conversations intervention for neonatal intensive care unit nurse practitioners: A randomized controlled trial.,"BACKGROUND


Neonatal nurse practitioners are often the front line providers in discussing unexpected news with parents. This study seeks to evaluate whether a simulation based Difficult Conversations Workshop for neonatal nurse practitioners leads to improved skills in conducting difficult conversations.
METHODS


We performed a randomized controlled study of a simulation based Difficult Conversations Workshop for neonatal nurse practitioners (n = 13) in a regional level IV neonatal intensive care unit to test the hypothesis that this intervention would improve communication skills. A simulated test conversation was performed after the workshop by the intervention group and before the workshop by the control group. Two independent blinded content experts scored each conversation using a quantitative communication skills performance checklist and by assigning an empathy score. Standard statistical analysis was performed.
RESULTS


Randomization occurred as follows: n = 5 to the intervention group, n = 7 to the control group. All participants were analyzed in each group. Participation in the simulation based Difficult Conversations Workshop increases participants' empathy score (p = 0.015) and the use of communication skills (p = 0.013) in a simulated clinical encounter.
CONCLUSIONS


Our study demonstrates that a lecture and simulation based Difficult Conversations Workshop for neonatal nurse practitioners improves objective communication skills and empathy in conducting difficult conversations.",2020,"Participation in the simulation based Difficult Conversations Workshop increases participants' empathy score (p = 0.015) and the use of communication skills (p = 0.013) in a simulated clinical encounter.
","['neonatal intensive care unit nurse practitioners', 'neonatal nurse practitioners', 'neonatal nurse practitioners (n = 13) in a regional level IV neonatal intensive care unit']","['A simulation based difficult conversations intervention', 'lecture and simulation based Difficult Conversations Workshop', 'simulation based Difficult Conversations Workshop']","[""participants' empathy score"", 'communication skills']","[{'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0028657', 'cui_str': 'Nurse practitioner (occupation)'}, {'cui': 'C0600089', 'cui_str': 'Nurses, Neonatal'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332218', 'cui_str': 'With difficulty'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}]","[{'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}]",13.0,0.0744612,"Participation in the simulation based Difficult Conversations Workshop increases participants' empathy score (p = 0.015) and the use of communication skills (p = 0.013) in a simulated clinical encounter.
","[{'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Bowen', 'Affiliation': 'Department of Neonatology, Women & Infants Hospital, Providence, RI, United States of America.'}, {'ForeName': 'Kate M', 'Initials': 'KM', 'LastName': 'Lally', 'Affiliation': 'Program in Palliative Care, Care New England Health System, Providence, RI, United States of America.'}, {'ForeName': 'Francine R', 'Initials': 'FR', 'LastName': 'Pingitore', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, United States of America.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Tucker', 'Affiliation': 'Department of Neonatology, Women & Infants Hospital, Providence, RI, United States of America.'}, {'ForeName': 'Elisabeth C', 'Initials': 'EC', 'LastName': 'McGowan', 'Affiliation': 'Department of Neonatology, Women & Infants Hospital, Providence, RI, United States of America.'}, {'ForeName': 'Beatrice E', 'Initials': 'BE', 'LastName': 'Lechner', 'Affiliation': 'Department of Neonatology, Women & Infants Hospital, Providence, RI, United States of America.'}]",PloS one,['10.1371/journal.pone.0229895']
3477,32162392,Efficacy of noncultured melanocyte-keratinocyte cell suspension vs hair follicular cell suspension transfer in stable vitiligo: A randomized controlled trial.,,2020,,['stable vitiligo'],['noncultured melanocyte-keratinocyte cell suspension vs hair follicular cell suspension transfer'],[],"[{'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}]","[{'cui': 'C0025201', 'cui_str': 'Melanocyte (cell)'}, {'cui': 'C0022567', 'cui_str': 'Keratinocyte (cell)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}, {'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0439682', 'cui_str': 'Follicular (qualifier value)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}]",[],,0.0992653,,"[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Moosavi', 'Affiliation': 'Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Miramin Mohammadi', 'Affiliation': 'Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Khadijeh', 'Initials': 'K', 'LastName': 'Tavakkoli', 'Affiliation': 'Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Vijaya T', 'Initials': 'VT', 'LastName': 'Daniel', 'Affiliation': 'Department of Dermatology, University of Massachusetts, Worcester, Massachusetts, USA.'}, {'ForeName': 'Zeynab', 'Initials': 'Z', 'LastName': 'Variji', 'Affiliation': 'Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Javadi', 'Affiliation': 'Department of Social Sciences, School of Medicine, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Leili', 'Initials': 'L', 'LastName': 'Feizi Konjini', 'Affiliation': 'Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Firooz', 'Affiliation': 'Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences, Tehran, Iran.'}]",Dermatologic therapy,['10.1111/dth.13309']
3478,31925605,A Cluster Randomized Trial of a Community-Based Intervention Among African-American Adults: Effects on Dietary and Physical Activity Outcomes.,"Evidence of the effectiveness of community-based lifestyle behavior change interventions among African-American adults is mixed. We implemented a behavioral lifestyle change intervention, Heart Matters, in two rural counties in North Carolina with African-American adults. Our aim was to evaluate the effect of Heart Matters on dietary and physical activity behaviors, self-efficacy, and social support. We used a cluster randomized controlled trial to compare Heart Matters to a delayed intervention control group after 6 months. A total of 143 African-American participants were recruited and 108 completed 6-month follow-up assessments (75.5%). We used mixed regression models to evaluate changes in outcomes from baseline to 6-month follow-up. The intervention had a significant positive effect on self-reported scores of encouragement of healthy eating, resulting in an increase in social support from family of 6.11 units (95% CI [1.99, 10.22]) (p < .01). However, intervention participants also had an increase in discouragement of healthy eating compared to controls of 5.59 units (95% CI [1.46, 9.73]) among family (p < .01). There were no significant differences in changes in dietary behaviors. Intervention participants had increased odds (OR = 2.86, 95% CI [1.18, 6.93]) of increased frequency of vigorous activity for at least 20 min per week compared to control participants (p < .05). Individual and group lifestyle behavior counseling can have a role in promoting physical activity levels among rural African-American adults, but more research is needed to identify the best strategies to bolster effectiveness and influence dietary change. Trial Registration: Clinical Trials, NCT02707432. Registered 13 March 2016.",2020,"Intervention participants had increased odds (OR = 2.86, 95% CI [1.18, 6.93]) of increased frequency of vigorous activity for at least 20 min per week compared to control participants (p < .05).","['two rural counties in North Carolina with African-American adults', 'African-American Adults', 'African-American adults', '143 African-American participants were recruited and 108 completed 6-month follow-up assessments (75.5', 'rural African-American adults']","['community-based lifestyle behavior change interventions', 'Community-Based Intervention', 'Individual and group lifestyle behavior counseling']","['discouragement of healthy eating', 'self-reported scores of encouragement of healthy eating', 'physical activity levels', 'dietary and physical activity behaviors, self-efficacy, and social support', 'dietary behaviors', 'frequency of vigorous activity', 'social support']","[{'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0037438'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",143.0,0.0579481,"Intervention participants had increased odds (OR = 2.86, 95% CI [1.18, 6.93]) of increased frequency of vigorous activity for at least 20 min per week compared to control participants (p < .05).","[{'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Frerichs', 'Affiliation': 'Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, 1102C McGavran-Greenberg Hall, Campus Box 7411, Chapel Hill, NC, 27599-7411, USA. leahf@unc.edu.'}, {'ForeName': 'Kiana', 'Initials': 'K', 'LastName': 'Bess', 'Affiliation': 'Center for Health Equity Research, Department of Social Medicine, University of North Carolina at Chapel Hill, Chapel Hill, USA.'}, {'ForeName': 'Tiffany L', 'Initials': 'TL', 'LastName': 'Young', 'Affiliation': 'The North Carolina Translational Research and Clinical Sciences Institute, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Hoover', 'Affiliation': 'Center for Health Equity Research, Department of Social Medicine, University of North Carolina at Chapel Hill, Chapel Hill, USA.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Calancie', 'Affiliation': 'Center for Health Equity Research, Department of Social Medicine, University of North Carolina at Chapel Hill, Chapel Hill, USA.'}, {'ForeName': 'Mysha', 'Initials': 'M', 'LastName': 'Wynn', 'Affiliation': 'Project Momentum, Inc., Rocky Mount, USA.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'McFarlin', 'Affiliation': 'James McFarlin Community Development, Inc., Rocky Mount, USA.'}, {'ForeName': 'Crystal W', 'Initials': 'CW', 'LastName': 'Cené', 'Affiliation': 'Department of Medicine, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, USA.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Dave', 'Affiliation': 'Center for Health Equity Research, Department of Social Medicine, University of North Carolina at Chapel Hill, Chapel Hill, USA.'}, {'ForeName': 'Giselle', 'Initials': 'G', 'LastName': 'Corbie-Smith', 'Affiliation': 'Center for Health Equity Research, Department of Social Medicine, University of North Carolina at Chapel Hill, Chapel Hill, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-019-01067-5']
3479,31216215,Pain Management in Corneal Collagen Crosslinking for Keratoconus: A Comparative Case Series.,"Purpose:  To compare management of postoperative pain after corneal collagen crosslinking (CXL) with oral gabapentin or ketorolac.  Methods:  Prospective interventional comparative case series in a single center. Patients undergoing epithelium-off (epi-off) or epithelium-on (epi-on) techniques performed by a single surgeon for progressive keratoconus were enrolled and randomly assigned to the ketorolac (10-mg tablets every 8 h) or the gabapentin (300-mg capsules every 8 h) group and instructed to take the medication for the first 3 postoperative days. Using a numeric scale of pain, scores were assessed for current pain (at the time of applying the questionnaire), and average pain over the preceding 24 h. Eye symptoms and systemic adverse events related to oral medication were also assessed.  Results:  Thirty-seven patients were included, with 22 (10 epi-on and 12 epi-off) assigned to the ketorolac group and 15 (7 epi-on and 8 epi-off) to the gabapentin group. No statistically significant differences were noted on the pain scale between groups at any point of the study, in the median pain scores of patients at the time of applying the questionnaire, nor in the severity of pain during the 24-h period before the assessment. Also, no differences were found among groups for the eye symptoms and the systemic adverse events. The median regression analysis showed no effect of the type of surgery or gender in the severity of pain.  Conclusions:  Both oral ketorolac and oral gabapentin can be used with similar results for pain and symptomatic control after epi-on or epi-off CXL procedures.",2019,"No statistically significant differences were noted on the pain scale between groups at any point of the study, in the median pain scores of patients at the time of applying the questionnaire, nor in the severity of pain during the 24-h period before the assessment.","['Thirty-seven patients were included, with 22 (10 epi-on and 12 epi-off) assigned to the', 'Patients undergoing epithelium-off (epi-off) or epithelium-on (epi-on) techniques performed by a single surgeon for progressive keratoconus', 'Corneal Collagen Crosslinking for Keratoconus']","['Pain Management', 'corneal collagen crosslinking (CXL) with oral gabapentin or ketorolac', 'ketorolac', 'gabapentin', 'ketorolac and oral gabapentin']","['eye symptoms and the systemic adverse events', 'current pain', 'pain scale', 'average pain', 'pain and symptomatic control', 'median pain scores', 'severity of pain']","[{'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0267963', 'cui_str': 'Pancreatic Insufficiency'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0014609', 'cui_str': 'Epithelial Tissue'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}]","[{'cui': 'C0586406', 'cui_str': 'Eye symptom'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",37.0,0.0282549,"No statistically significant differences were noted on the pain scale between groups at any point of the study, in the median pain scores of patients at the time of applying the questionnaire, nor in the severity of pain during the 24-h period before the assessment.","[{'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Serna-Ojeda', 'Affiliation': '1Department of Cornea and Refractive Surgery, Instituto de Oftalmologia ""Conde de Valenciana,"" Mexico City, Mexico.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Santana-Cruz', 'Affiliation': '1Department of Cornea and Refractive Surgery, Instituto de Oftalmologia ""Conde de Valenciana,"" Mexico City, Mexico.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Quiroz-Casian', 'Affiliation': '1Department of Cornea and Refractive Surgery, Instituto de Oftalmologia ""Conde de Valenciana,"" Mexico City, Mexico.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'González-Mendoza', 'Affiliation': '1Department of Cornea and Refractive Surgery, Instituto de Oftalmologia ""Conde de Valenciana,"" Mexico City, Mexico.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Mercado-Orozco', 'Affiliation': '1Department of Cornea and Refractive Surgery, Instituto de Oftalmologia ""Conde de Valenciana,"" Mexico City, Mexico.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Navas', 'Affiliation': '1Department of Cornea and Refractive Surgery, Instituto de Oftalmologia ""Conde de Valenciana,"" Mexico City, Mexico.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Lichtinger', 'Affiliation': '1Department of Cornea and Refractive Surgery, Instituto de Oftalmologia ""Conde de Valenciana,"" Mexico City, Mexico.'}, {'ForeName': 'Enrique O', 'Initials': 'EO', 'LastName': 'Graue-Hernandez', 'Affiliation': '1Department of Cornea and Refractive Surgery, Instituto de Oftalmologia ""Conde de Valenciana,"" Mexico City, Mexico.'}]",Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics,['10.1089/jop.2019.0021']
3480,32041881,Cannabis increases susceptibility to false memory.,"With the growing global acceptance of cannabis and its widespread use by eyewitnesses and suspects in legal cases, understanding the popular drug's ramifications for memory is a pressing need. In a double-blind, randomized, placebo-controlled trial, we examined the acute and delayed effects of Δ9-tetrahydrocannabinol (THC) intoxication on susceptibility to false memory in 64 healthy volunteers. Memory was tested immediately (encoding and retrieval under drug influence) and 1 wk later (retrieval sober). We used three different methods (associative word lists and two misinformation tasks using virtual reality). Across all methods, we found evidence for enhanced false-memory effects in intoxicated participants. Specifically, intoxicated participants showed higher false recognition in the associative word-list task both at immediate and delayed test than controls. This yes bias became increasingly strong with decreasing levels of association between studied and test items. In a misinformation task, intoxicated participants were more susceptible to false-memory creation using a virtual-reality eyewitness scenario and virtual-reality perpetrator scenario. False-memory effects were mostly restricted to the acute-intoxication phase. Cannabis seems to increase false-memory proneness, with decreasing strength of association between an event and a test item, as assessed by different false-memory paradigms. Our findings have implications for how and when the police should interview suspects and eyewitnesses.",2020,"In a misinformation task, intoxicated participants were more susceptible to false-memory creation using a virtual-reality eyewitness scenario and virtual-reality perpetrator scenario.",['64 healthy volunteers'],"['placebo', 'Δ9-tetrahydrocannabinol (THC) intoxication']","['False-memory effects', 'false recognition']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0728899', 'cui_str': 'Intoxication'}]","[{'cui': 'C0561845', 'cui_str': 'False memories (finding)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0233798', 'cui_str': 'False recognition (finding)'}]",64.0,0.0937391,"In a misinformation task, intoxicated participants were more susceptible to false-memory creation using a virtual-reality eyewitness scenario and virtual-reality perpetrator scenario.","[{'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Kloft', 'Affiliation': 'Faculty of Psychology and Neuroscience, Maastricht University, 6229 ER Maastricht, The Netherlands; l.kloft@maastrichtuniversity.nl eloftus@uci.edu j.ramaekers@maastrichtuniversity.nl.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Otgaar', 'Affiliation': 'Faculty of Psychology and Neuroscience, Maastricht University, 6229 ER Maastricht, The Netherlands.'}, {'ForeName': 'Arjan', 'Initials': 'A', 'LastName': 'Blokland', 'Affiliation': 'Faculty of Psychology and Neuroscience, Maastricht University, 6229 ER Maastricht, The Netherlands.'}, {'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Monds', 'Affiliation': 'Faculty of Medicine and Health, The University of Sydney, Sydney, NSW 2006, Australia.'}, {'ForeName': 'Stefan W', 'Initials': 'SW', 'LastName': 'Toennes', 'Affiliation': 'Department of Forensic Toxicology, Institute of Legal Medicine, Goethe University of Frankfurt, 60323 Frankfurt, Germany.'}, {'ForeName': 'Elizabeth F', 'Initials': 'EF', 'LastName': 'Loftus', 'Affiliation': 'Department of Psychological Science, University of California, Irvine, CA 92697 l.kloft@maastrichtuniversity.nl eloftus@uci.edu j.ramaekers@maastrichtuniversity.nl.'}, {'ForeName': 'Johannes G', 'Initials': 'JG', 'LastName': 'Ramaekers', 'Affiliation': 'Faculty of Psychology and Neuroscience, Maastricht University, 6229 ER Maastricht, The Netherlands; l.kloft@maastrichtuniversity.nl eloftus@uci.edu j.ramaekers@maastrichtuniversity.nl.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.1920162117']
3481,32171278,"Assertive outreach treatment versus care as usual for the treatment of high-need, high-cost alcohol related frequent attenders: study protocol for a randomised controlled trial.","BACKGROUND


Alcohol-related hospital admissions have doubled in the last ten years to > 1.2 m per year in England. High-need, high-cost (HNHC) alcohol-related frequent attenders (ARFA) are a relatively small subgroup of patients, having multiple admissions or attendances from alcohol during a short time period. This trial aims to test the effectiveness of an assertive outreach treatment (AOT) approach in improving clinical outcomes for ARFA, and reducing resource use in the acute setting.
METHODS


One hundred and sixty ARFA patients will be recruited and following baseline assessment, randomly assigned to AOT plus care as usual (CAU) or CAU alone in equal numbers. Baseline assessment includes alcohol consumption and related problems, physical and mental health comorbidity and health and social care service use in the previous 6 months using standard validated tools, plus a measure of resource use. Follow-up assessments at 6 and 12 months after randomization includes the same tools as baseline plus standard measure of patient satisfaction. Outcomes for CAU + AOT and CAU at 6 and 12 months will be compared, controlling for pre-specified baseline measures. Primary outcome will be percentage of days abstinent at 12 months. Secondary outcomes include emergency department (ED) attendance, number and length of hospital admissions, alcohol consumption, alcohol-related problems, other health service use, mental and physical comorbidity 6 and 12 months post intervention. Health economic analysis will estimate the economic impact of AOT from health, social care and societal perspectives and explore cost-effectiveness in terms of quality adjusted life years and alcohol consumption at 12-month follow-up.
DISCUSSION


AOT models piloted with alcohol dependent patients have demonstrated significant reductions in alcohol consumption and use of unplanned National Health Service (NHS) care, with increased engagement with alcohol treatment services, compared with patients receiving CAU. While AOT interventions are costlier per case than current standard care in the UK, the rationale for targeting HNHC ARFAs is because of their disproportionate contribution to overall alcohol burden on the NHS. No previous studies have evaluated the clinical and cost-effectiveness of AOT for HNHC ARFAs: this randomized controlled trial (RCT) targeting ARFAs across five South London NHS Trusts is the first.
TRIAL REGISTRATION


International standard randomized controlled trial number (ISRCTN) registry: ISRCTN67000214, retrospectively registered 26/11/2016.",2020,"This trial aims to test the effectiveness of an assertive outreach treatment (AOT) approach in improving clinical outcomes for ARFA, and reducing resource use in the acute setting.
",['One hundred and\xa0sixty ARFA patients'],"['AOT plus care as usual (CAU) or CAU alone', 'Assertive outreach treatment', 'assertive outreach treatment (AOT) approach']","['percentage of days abstinent at 12\u2009months', 'emergency department (ED) attendance, number and length of hospital admissions, alcohol consumption, alcohol-related problems, other health service use, mental and physical comorbidity', 'alcohol consumption and related problems, physical and mental health comorbidity and health and social care service use', 'alcohol consumption and use of unplanned National Health Service (NHS) care']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0444892', 'cui_str': 'CAU'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0419189', 'cui_str': 'Social care (regime/therapy)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}]",160.0,0.137917,"This trial aims to test the effectiveness of an assertive outreach treatment (AOT) approach in improving clinical outcomes for ARFA, and reducing resource use in the acute setting.
","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Blackwood', 'Affiliation': ""National Addiction Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. rosalind.blackwood@kcl.ac.uk.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wolstenholme', 'Affiliation': ""National Addiction Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kimergård', 'Affiliation': ""National Addiction Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Fincham-Campbell', 'Affiliation': ""National Addiction Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Khadjesari', 'Affiliation': ""National Addiction Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Coulton', 'Affiliation': 'University of Kent, Kent, Canterbury, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Byford', 'Affiliation': ""King's Health Economics, Institute of Psychiatry, Psychology & Neuroscience at King's College London, London, UK.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Deluca', 'Affiliation': ""National Addiction Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Jennings', 'Affiliation': ""National Addiction Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Currell', 'Affiliation': ""National Addiction Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dunne', 'Affiliation': ""National Addiction Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': ""O'Toole"", 'Affiliation': 'NIHR Collaborations for Leadership in Applied Health Research and Care South London, London, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Winnington', 'Affiliation': 'South London and the Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Finch', 'Affiliation': 'South London and the Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Drummond', 'Affiliation': ""National Addiction Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]",BMC public health,['10.1186/s12889-020-8437-y']
3482,31751782,Risk factors for reporting adverse events and for study withdrawal in a population-based trial of vitamin D supplementation.,"With increasing numbers of randomized controlled trials (RCTs) investigating potential health events of vitamin D supplementation, a better understanding is required of the risk factors for adverse events and for study withdrawals. This analysis aimed to identify baseline risk factors of reporting an adverse event in a multi-year randomized double-blinded placebo-controlled trial of vitamin D supplementation. The secondary aim was to investigate if adverse events were associated with study withdrawals. We analyzed data from the Vitamin D Assessment (ViDA) study: 5110 adults, aged 50-84 years, living in Auckland, New Zealand. Monthly doses of 100,000 IU vitamin D3 or placebo were mailed to participants homes, with a questionnaire to collect data on adverse events and adherence to the study capsule (initially monthly, then 4-monthly). Median follow-up was 3.3 years. Data were analysed using multivariable log-binomial regression and Cox-regression. During the follow-up period, 818 people reported adverse events and 412 withdrew or stopped returning questionnaires. Vitamin D was not associated with reporting of adverse events. Of sociodemographic factors, ethnicity was associated with reporting adverse events: compared to European participants, Maori and Pacific Islander people were more likely to report an adverse event. Non-smokers were more likely to report an adverse event, compared to smokers (adjusted hazard ratio (HR) = 1.80; 95%CI = 1.24, 2.62); as were those who had reported a history of depression (adjusted HR = 1.27; 95%CI = 1.01, 1.60) or a recent cough or cold (adjusted HR = 1.22; 95%CI = 1.03, 1.44) at baseline. Reporting of adverse events was not associated with withdrawals (adjusted HR = 1.12; 95%CI = 0.86, 1.46). These data did not identify any clear pattern in the factors associated with self-reported adverse events, which themselves did not increase risk of withdrawals.",2020,"Of sociodemographic factors, ethnicity was associated with reporting adverse events: compared to European participants, Maori and Pacific Islander people were more likely to report an adverse event.","['5,110 adults, aged 50-84 years, living in Auckland, New Zealand']","['placebo', 'vitamin D supplementation', 'vitamin D3 or placebo', 'Vitamin D']","['history of depression', 'adverse events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]","[{'cui': 'C0455503', 'cui_str': 'H/O: depression'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",818.0,0.556737,"Of sociodemographic factors, ethnicity was associated with reporting adverse events: compared to European participants, Maori and Pacific Islander people were more likely to report an adverse event.","[{'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Malihi', 'Affiliation': 'School of Population Health, University of Auckland, New Zealand.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'School of Population Health, University of Auckland, New Zealand.'}, {'ForeName': 'Cmm', 'Initials': 'C', 'LastName': 'Lawes', 'Affiliation': 'School of Population Health, University of Auckland, New Zealand.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sluyter', 'Affiliation': 'School of Population Health, University of Auckland, New Zealand.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Waayer', 'Affiliation': 'School of Population Health, University of Auckland, New Zealand.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Toop', 'Affiliation': 'Department of Public Health & General Practice, The University of Otago, New Zealand.'}, {'ForeName': 'K-T', 'Initials': 'KT', 'LastName': 'Khaw', 'Affiliation': 'Department of Public Health, University of Cambridge, England, United Kingdom.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Camargo', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Scragg', 'Affiliation': 'School of Population Health, University of Auckland, New Zealand. Electronic address: r.scragg@auckland.ac.nz.'}]",The Journal of steroid biochemistry and molecular biology,['10.1016/j.jsbmb.2019.105546']
3483,31750676,Small sustainable monetary donation-based incentives to promote physical activity: A randomized controlled trial.,"OBJECTIVE


To pilot test two low-cost and thus financially sustainable incentive programs to promote physical activity (PA) among low-active adults in a community setting.
METHOD


In a three-arm randomized controlled trial the effects of small monetary incentives (cash incentives $1/day;  n  = 25) were compared to charitable donations (donation $1/day;  n  = 25) and a control group ( n  = 25) on PA behavior over the course of 12 months in insufficiently active, otherwise healthy adults. Incentives were based on attendance at a local YMCA. Electronic swipe card data from the YMCA was the primary outcome, with self-reported minutes of PA as a secondary outcome.
RESULTS


Quantile regression models showed promising effects of treatment allocation on the primary outcome (attendance) adjusted for age and employment. There was a difference between cash incentives and control conditions such that median attendance in the cash incentives condition was 19.24 visits more over 12 months ( b  = 19.24;  SE  = 8.26, 95% CI [2.75, 35.72]). There was a similar though only marginally significant trend for the donation condition showing that participants in the donation condition made 11.88 additional visits to the YMCA over 12 months relative to the control condition ( b  = 11.88,  SE  = 8.41,95% CI [-0.91, 28.67]). There was a significant correlation between objectively verified YMCA attendance and self-reported moderate-to-vigorous PA at the YMCA (ρ = 0.587) over 12 months.
CONCLUSIONS


These promising findings provide early support for small monetary incentives and charitable donations for promoting PA in community settings. Further research on the efficacy of using financially sustainable incentive programs, including charitable donations, for PA through community organizations (e.g., YMCAs) seems warranted. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,"Further research on the efficacy of using financially sustainable incentive programs, including charitable donations, for PA through community organizations (e.g., YMCAs) seems warranted.",['low-active adults in a community setting'],"['YMCA', 'small monetary incentives (cash incentives $1/day;  n  = 25) were compared to charitable donations (donation $1/day;  n  = 25) and a control group ( n  = 25) on PA behavior']","['physical activity (PA', 'YMCA attendance and self-reported moderate-to-vigorous PA']","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4049936', 'cui_str': 'Donation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]",2019.0,0.179817,"Further research on the efficacy of using financially sustainable incentive programs, including charitable donations, for PA through community organizations (e.g., YMCAs) seems warranted.","[{'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Galárraga', 'Affiliation': 'Department of Health Services, Policy and Practice.'}, {'ForeName': 'Lauren Connell', 'Initials': 'LC', 'LastName': 'Bohlen', 'Affiliation': 'Department of Kinesiology.'}, {'ForeName': 'Shira I', 'Initials': 'SI', 'LastName': 'Dunsiger', 'Affiliation': 'Department of Behavioral and Social Sciences.'}, {'ForeName': 'Harold H', 'Initials': 'HH', 'LastName': 'Lee', 'Affiliation': 'Department of Behavioral and Social Sciences.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Emerson', 'Affiliation': 'Department of Behavioral and Social Sciences.'}, {'ForeName': 'Holly K', 'Initials': 'HK', 'LastName': 'Boyle', 'Affiliation': 'Department of Behavioral and Social Sciences.'}, {'ForeName': 'Kelley', 'Initials': 'K', 'LastName': 'Strohacker', 'Affiliation': 'Department of Kinesiology, Recreation, and Sport Studies.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Williams', 'Affiliation': 'Department of Behavioral and Social Sciences.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000818']
3484,32176364,Additional postdilatation using noncompliant balloons after everolimus-eluting stent implantation: Results of the PRESS trial.,"BACKGROUND


There are limited data on the clinical value of routine postdilatation using noncompliant balloons after contemporary drug-eluting stent implantation.
HYPOTHESIS


Additional postdilatation using noncompliant balloons after everolimus-eluting stent implantation could provide better clinical outcomes.
METHODS


We randomly assigned 1774 patients with coronary artery disease to undergo additional high-pressure postdilatation using noncompliant balloons and moderate-pressure dilatation using stent balloons after everolimus-eluting stent implantation. The primary endpoint was a composite of death, myocardial infarction (MI), stent thrombosis, and target vessel revascularization (TVR) 2 years after randomization.
RESULTS


The study was discontinued early owing to slow enrollment. In total, 810 patients (406 patients in the high pressure group and 404 in the moderate pressure group) were finally enrolled. At 2 years, the primary endpoint occurred in 3.6% of patients in the high pressure group and in 4.4% of those in the moderate pressure group (P = .537). In addition, no significant differences were observed between the two groups in the occurrence of an individual end point of death (0.8% in the high pressure group vs 1.5% in the moderate group, P = .304), MI (0.2% vs 0.5%, P = .554), stent thrombosis (0% vs 0.2%, P = .316), or TVR (2.8% vs 2.6%, P = .880).
CONCLUSIONS


The strategy of routine postdilatation using noncompliant balloons after everolimus-eluting stent implantation did not provide incremental clinical benefits.",2020,"The primary endpoint was a composite of death, myocardial infarction (MI), stent thrombosis, and target vessel revascularization (TVR) 2 years after randomization.
","['810 patients (406 patients in the high pressure group and 404 in the moderate pressure group) were finally enrolled', '1774 patients with coronary artery disease to undergo additional high-pressure postdilatation using noncompliant balloons and moderate-pressure dilatation using stent balloons after everolimus-eluting stent implantation']",['everolimus-eluting stent implantation'],"['TVR', 'MI', 'occurrence of an individual end point of death', 'composite of death, myocardial infarction (MI), stent thrombosis, and target vessel revascularization (TVR) 2\u2009years after randomization', 'stent thrombosis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]",1774.0,0.0811106,"The primary endpoint was a composite of death, myocardial infarction (MI), stent thrombosis, and target vessel revascularization (TVR) 2 years after randomization.
","[{'ForeName': 'Gyung-Min', 'Initials': 'GM', 'LastName': 'Park', 'Affiliation': 'Department of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea.'}, {'ForeName': 'Jae-Hwan', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Cardiology, Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon, South Korea.'}, {'ForeName': 'Si Wan', 'Initials': 'SW', 'LastName': 'Choi', 'Affiliation': 'Department of Cardiology, Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon, South Korea.'}, {'ForeName': 'Jin-Ok', 'Initials': 'JO', 'LastName': 'Jeong', 'Affiliation': 'Department of Cardiology, Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon, South Korea.'}, {'ForeName': 'Eun-Seok', 'Initials': 'ES', 'LastName': 'Shin', 'Affiliation': 'Department of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea.'}, {'ForeName': 'Jang-Whan', 'Initials': 'JW', 'LastName': 'Bae', 'Affiliation': 'Department of Internal Medicine, Chungbuk National University College of Medicine, Cheongju, South Korea.'}, {'ForeName': 'Hyuck-Jun', 'Initials': 'HJ', 'LastName': 'Yoon', 'Affiliation': 'Department of Cardiology, Keimyung University Dongsan Medical Center, Daegu, South Korea.'}, {'ForeName': 'Kyung Tae', 'Initials': 'KT', 'LastName': 'Jung', 'Affiliation': 'Department of Cardiology, Eulji University Hospital, Daejeon, South Korea.'}, {'ForeName': 'Ju Yeol', 'Initials': 'JY', 'LastName': 'Baek', 'Affiliation': ""Department of Cardiology, Cheongju St. Mary's Hospital, Cheongju, South Korea.""}, {'ForeName': 'Woong Gil', 'Initials': 'WG', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Konkuk University, Chungju, South Korea.'}, {'ForeName': 'Rak Kyeong', 'Initials': 'RK', 'LastName': 'Choi', 'Affiliation': 'Department of Cardiology, Mediplex Sejong Hospital, Bucheon, South Korea.'}, {'ForeName': 'Sung-Ho', 'Initials': 'SH', 'LastName': 'Her', 'Affiliation': ""Department of Cardiology, Daejeon St. Mary's Hospital, The Catholic University of Korea, Seoul, South Korea.""}, {'ForeName': 'Jin Bae', 'Initials': 'JB', 'LastName': 'Lee', 'Affiliation': 'Department of Cardiology, Daegu Catholic University Medical Center, Daegu, South Korea.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Suh', 'Affiliation': 'Department of Cardiology, Soonchunhyang University Bucheon Hospital, Bucheon, South Korea.'}, {'ForeName': 'Jae Beom', 'Initials': 'JB', 'LastName': 'Lee', 'Affiliation': 'Department of Cardiology, Anyang Sam Hospital, Anyang, South Korea.'}, {'ForeName': 'Se-Whan', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': 'Department of Cardiology, Soonchunhyang University Cheonan Hospital, Cheonan, South Korea.'}, {'ForeName': 'In-Ho', 'Initials': 'IH', 'LastName': 'Chae', 'Affiliation': 'Department of Cardiology, Seoul National University Bundang Hospital, Bundang, South Korea.'}, {'ForeName': 'So-Yeon', 'Initials': 'SY', 'LastName': 'Choi', 'Affiliation': 'Department of Cardiology, Ajou University Hospital, Suwon, South Korea.'}, {'ForeName': 'In-Whan', 'Initials': 'IW', 'LastName': 'Seong', 'Affiliation': 'Department of Cardiology, Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon, South Korea.'}]",Clinical cardiology,['10.1002/clc.23355']
3485,31332524,Home-based parent training for school-aged children with attention-deficit/hyperactivity disorder and behavior problems with remaining impairing disruptive behaviors after routine treatment: a randomized controlled trial.,"The objective is to investigate the effectiveness of home-based behavioral parent training for school-aged children with attention-deficit/hyperactivity disorder (ADHD) and behavior problems with remaining impairing disruptive behaviors after routinely offered treatments in clinical practice. In a randomized controlled study including 73 referred children with ADHD and impairing disruptive symptoms after routine clinical pharmacotherapy and/or clinic-based parent training had been tried or, at least, offered, home-based behavioral parent training (n = 26) was compared to a waiting list (n = 23) and a care-as-usual home-based treatment (n = 24). It was unknown to families which of the home-based treatments that they received. Using mixed models for repeated measures, we examined the effectiveness on the primary outcome measure of children's severity of disruptive behaviors and on a number of secondary outcome measures [the degree to which parents experienced the disruptive behaviors as troublesome, ADHD symptoms, oppositional-defiant disorder (ODD) symptoms, and internalizing problems]. Compared to the waiting list, children receiving home-based parent training improved significantly more regarding severity of disruptive behaviors (ES = 0.75), ADHD symptoms (ES = 0.89), ODD symptoms (ES = 0.65), and internalizing problems (ES = 0.60). Compared to care-as-usual, home-based parent training was more effective in reducing disruptive behaviors (ES = 0.57), ADHD symptoms (ES = 0.89), and ODD symptoms (ES = 0.88). Significantly more reduction of children's internalizing problems was not found. In conclusion, children with ADHD and residual behavioral problems after routine treatment may benefit from home-based behavioral parent training.",2020,"Compared to care-as-usual, home-based parent training was more effective in reducing disruptive behaviors (ES = 0.57), ADHD symptoms (ES = 0.89), and ODD symptoms (ES = 0.88).","['73 referred children with ADHD and impairing disruptive symptoms after routine clinical pharmacotherapy and/or clinic-based parent training had been tried or, at least, offered', 'school-aged children with attention-deficit/hyperactivity disorder and behavior problems with remaining impairing disruptive behaviors after routine treatment', 'school-aged children with attention-deficit/hyperactivity disorder (ADHD) and behavior problems with remaining impairing disruptive behaviors after routinely offered treatments in clinical practice', 'children with ADHD and residual behavioral problems']","['care-as-usual home-based treatment', 'home-based behavioral parent training', 'Home-based parent training']","['disruptive behaviors', 'ODD symptoms', 'severity of disruptive behaviors', 'ADHD symptoms', ""children's internalizing problems"", ""children's severity of disruptive behaviors"", 'disruptive behaviors as troublesome, ADHD symptoms, oppositional-defiant disorder (ODD) symptoms, and internalizing problems']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0474416', 'cui_str': 'Disruptive Behavior'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0233514', 'cui_str': 'Behavioral Problem'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0474416', 'cui_str': 'Disruptive Behavior'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0029121', 'cui_str': 'Oppositional Defiant Disorder'}]",73.0,0.0706845,"Compared to care-as-usual, home-based parent training was more effective in reducing disruptive behaviors (ES = 0.57), ADHD symptoms (ES = 0.89), and ODD symptoms (ES = 0.88).","[{'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Nobel', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Medical Center Groningen, University of Groningen, Hanzeplein 1 XA10, NL-9713 GZ, Groningen, The Netherlands.'}, {'ForeName': 'Pieter J', 'Initials': 'PJ', 'LastName': 'Hoekstra', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Medical Center Groningen, University of Groningen, Hanzeplein 1 XA10, NL-9713 GZ, Groningen, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Agnes Brunnekreef', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Medical Center Groningen, University of Groningen, Hanzeplein 1 XA10, NL-9713 GZ, Groningen, The Netherlands.'}, {'ForeName': 'Dieneke E H', 'Initials': 'DEH', 'LastName': 'Messink-de Vries', 'Affiliation': 'Department of Youth Mental Health, GGZ In de Bres, Drachten, The Netherlands.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Fischer', 'Affiliation': 'Jonx, Department of Youth Mental Health and Autism, Lentis Psychiatric Institute, Groningen, The Netherlands.'}, {'ForeName': 'Paul M G', 'Initials': 'PMG', 'LastName': 'Emmelkamp', 'Affiliation': 'Department of Clinical Psychology, Netherlands Institute for Advanced Study, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'van den Hoofdakker', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Medical Center Groningen, University of Groningen, Hanzeplein 1 XA10, NL-9713 GZ, Groningen, The Netherlands. e.nobel@me.com.'}]",European child & adolescent psychiatry,['10.1007/s00787-019-01375-9']
3486,32022771,One-year Results of a Factorial Randomized Trial of Aspirin versus Placebo and Clonidine versus Placebo in Patients Having Noncardiac Surgery.,"BACKGROUND


The authors previously reported that perioperative aspirin and/or clonidine does not prevent a composite of death or myocardial infarction 30 days after noncardiac surgery. Moreover, aspirin increased the risk of major bleeding and clonidine caused hypotension and bradycardia. Whether these complications produce harm at 1 yr remains unknown.
METHODS


The authors randomized 10,010 patients with or at risk of atherosclerosis and scheduled for noncardiac surgery in a 1:1:1:1 ratio to clonidine/aspirin, clonidine/aspirin placebo, clonidine placebo/aspirin, or clonidine placebo/aspirin placebo. Patients started taking aspirin or placebo just before surgery; those not previously taking aspirin continued daily for 30 days, and those taking aspirin previously continued for 7 days. Patients were also randomly assigned to receive clonidine or placebo just before surgery, with the study drug continued for 72 h.
RESULTS


Neither aspirin nor clonidine had a significant effect on the primary 1-yr outcome, a composite of death or nonfatal myocardial infarction, with a 1-yr hazard ratio for aspirin of 1.00 (95% CI, 0.89 to 1.12; P = 0.948; 586 patients [11.8%] vs. 589 patients [11.8%]) and a hazard ratio for clonidine of 1.07 (95% CI, 0.96 to 1.20; P = 0.218; 608 patients [12.1%] vs. 567 patients [11.3%]), with effect on death or nonfatal infarction. Reduction in death and nonfatal myocardial infarction from aspirin in patients who previously had percutaneous coronary intervention at 30 days persisted at 1 yr. Specifically, the hazard ratio was 0.58 (95% CI, 0.35 to 0.95) in those with previous percutaneous coronary intervention and 1.03 (95% CI, 0.91to 1.16) in those without (interaction P = 0.033). There was no significant effect of either drug on death, cardiovascular complications, cancer, or chronic incisional pain at 1 yr (all P > 0.1).
CONCLUSIONS


Neither perioperative aspirin nor clonidine have significant long-term effects after noncardiac surgery. Perioperative aspirin in patients with previous percutaneous coronary intervention showed persistent benefit at 1 yr, a plausible sub-group effect.",2020,"There was no significant effect of either drug on death, cardiovascular complications, cancer, or chronic incisional pain at 1 yr (all P > 0.1).
","['Patients Having Noncardiac Surgery', 'patients who previously had percutaneous coronary intervention at 30 days persisted at 1 yr', '10,010 patients with or at risk of atherosclerosis and scheduled for noncardiac surgery in a 1:1:1:1 ratio to', 'patients with previous percutaneous coronary intervention']","['Placebo', 'aspirin or placebo', 'Aspirin', 'clonidine/aspirin, clonidine/aspirin placebo, clonidine placebo/aspirin, or clonidine placebo/aspirin placebo', 'Perioperative aspirin', 'clonidine or placebo', 'clonidine', 'aspirin and/or clonidine', 'Placebo and Clonidine', 'aspirin']","['hazard ratio', 'risk of major bleeding and clonidine caused hypotension and bradycardia', 'death, cardiovascular complications, cancer, or chronic incisional pain', 'nonfatal myocardial infarctions and/or deaths', 'composite of death or nonfatal myocardial infarction, with a 1-yr hazard ratio for aspirin', 'death or nonfatal infarction', 'death and nonfatal myocardial infarction', 'perioperative bleeding, and clonidine provoked hypotension and bradycardia', '30-day composite of nonfatal myocardial infarction or death', 'infarctions or deaths', 'nonfatal myocardial infarction or death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",10010.0,0.539866,"There was no significant effect of either drug on death, cardiovascular complications, cancer, or chronic incisional pain at 1 yr (all P > 0.1).
","[{'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': ""From the Department of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, Ohio (D.I.S., A.K., A.T.) Population Health Research Institute (D.I.S., D.C., S.Y., Y.L.M., A.L., K.B., S.P., P.J.D.) Department of Medicine (D.C., S.Y., G.G., P.J.D.) Department of Health Research Methods, Evidence, and Impact (D.C., S.Y., G.G., Y.L.M., A.L., P.J.D.) Faculty of Health Sciences, Department of Anesthesia (Y.L.M.) Department of Surgery (R.W., A.L.), McMaster University, Hamilton, Ontario, Canada Department of Anaesthesia and Pain Management, Royal Melbourne Hospital and Centre for Integrated Critical Care, University of Melbourne, Melbourne, Australia (K.L.) Public Health and Clinical Epidemiology-Iberoamerican Cochrane Centre, Barcelona, Spain (E.P.) University of Alberta and Mazankowski Alberta Heart Institute, Edmonton, Alberta, Canada (M.G.) Department of Research, Foundation for Pediatric Cardiology, Institute of Cardiology and Faculty of Health Sciences (Departamento de Investigaciones, Fundación Cardioinfantil-Instituto de Cardiología and Facultad de Ciencias de la Salud), Universidad Autónoma de Bucaramanga, Colombia (J.C.V.) University of Western Ontario, London, Ontario, Canada (M.M.) Department of Clinical Research, Narayana Hrudayalaya Limited, Bangalore, India (A.S.) University of Cape Town and Groote Schuur Hospital, Cape Town, South Africa (B.M.B.) Department of Anaesthesia and Intensive Care, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark (C.S.M.) Department of Anesthesiology and Perioperative Medicine, Kingston Health Sciences Centre and Queen's University, Kingston, Canada (J.L.P., I.G.) St. John's Medical College and Research Institute, Bangalore, Karnataka, India (D.X.) Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Hong Kong (M.T.V.C.) University of North Carolina School of Medicine, Chapel Hills, North Carolina (P.A.K.) NHS Grampian and the University of Aberdeen, Aberdeen, United Kingdom (P.F.) Knowledge and Evidence Unite (Unidad de Conocimiento y Evidencia), Universidad Peruana Cayetano Heredia, Lima, Peru (G.M.) Department of Anaesthesia, Intensive Care, and Pain Medicine, Medical University of Vienna, Vienna, Austria (E.F.) Shifa International Hospitals, Islamabad, Pakistan (M.A.) University of the Andes and Santa Maria Clinic (Universidad de Los Andes and Clinica Santa María), Santiago, Chile (D.T.) Department of Anesthesiology, University of Malaya, Kuala Lumpur, Malaysia (C.Y.W.) Biomedical Research Institute (IIB - Sant Pau), Barcelona, Spain (P.P.) Hospital Israelita Albert Einstein, São Paulo, Brazil (O.B.) Department of Surgery, University of Manitoba, Winnipeg, Manitoba, Canada (S.S.) Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute and Vita-Salute University, Milan, Italy (G.L.).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Conen', 'Affiliation': ''}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Leslie', 'Affiliation': ''}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': ''}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Popova', 'Affiliation': ''}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Graham', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Kurz', 'Affiliation': ''}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Villar', 'Affiliation': ''}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Mrkobrada', 'Affiliation': ''}, {'ForeName': 'Alben', 'Initials': 'A', 'LastName': 'Sigamani', 'Affiliation': ''}, {'ForeName': 'Bruce M', 'Initials': 'BM', 'LastName': 'Biccard', 'Affiliation': ''}, {'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Meyhoff', 'Affiliation': ''}, {'ForeName': 'Joel L', 'Initials': 'JL', 'LastName': 'Parlow', 'Affiliation': ''}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Guyatt', 'Affiliation': ''}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Xavier', 'Affiliation': ''}, {'ForeName': 'Matthew T V', 'Initials': 'MTV', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'Priya A', 'Initials': 'PA', 'LastName': 'Kumar', 'Affiliation': ''}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Forget', 'Affiliation': ''}, {'ForeName': 'German', 'Initials': 'G', 'LastName': 'Malaga', 'Affiliation': ''}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Fleischmann', 'Affiliation': ''}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Amir', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Torres', 'Affiliation': ''}, {'ForeName': 'C Y', 'Initials': 'CY', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Paniagua', 'Affiliation': ''}, {'ForeName': 'Otavio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': ''}, {'ForeName': 'Sadeesh', 'Initials': 'S', 'LastName': 'Srinathan', 'Affiliation': ''}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Landoni', 'Affiliation': ''}, {'ForeName': 'Yannick Le', 'Initials': 'YL', 'LastName': 'Manach', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Whitlock', 'Affiliation': ''}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Lamy', 'Affiliation': ''}, {'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Balasubramanian', 'Affiliation': ''}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Gilron', 'Affiliation': ''}, {'ForeName': 'Alparslan', 'Initials': 'A', 'LastName': 'Turan', 'Affiliation': ''}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Pettit', 'Affiliation': ''}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Devereaux', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003158']
3487,31618466,Immediate skin-to-skin contact is feasible for very preterm infants but thermal control remains a challenge.,"AIM


Current care of very preterm infants in an incubator implies separation of the mother-infant dyad. The aim of this study was to determine whether skin-to-skin contact (SSC) between parent and very preterm infant from birth and during the first postnatal hour is feasible.
METHODS


Infants born in 2014-16 in Stockholm at gestational age 28 + 0-33 + 6 weeks were randomised to care provided in SSC with a parent or on a resuscitaire and later in an incubator or bed during the first postnatal hour. Infant body temperature was measured on admission to the neonatal unit and at one postnatal hour. Data on respiratory support and breastfeeding were prospectively collected.
RESULTS


We studied 55 infants at 32 + 0 ± 1.4 weeks (range 28 + 2-33 + 6), with birthweight 1760 g ± 449 g (range 885-2822). 60% were boys. Mean body temperature in the SSC group was 0.3°C lower 1 hour after birth, 36.3°C ± 0.52 (range 34.4-37.2) vs 36.6°C ± 0.42 (range 36.0-37.4, P = .03). No differences between groups were seen in respiratory support or breastfeeding.
CONCLUSION


Stabilisation of very preterm infants can be performed while in SSC with a parent, but caution needs to be paid to maintain normothermia.",2020,"No differences between groups were seen in respiratory support or breastfeeding.
","['very preterm infants in an incubator implies separation of the mother-infant dyad', 'Infants born in 2014-16 in Stockholm at gestational age 28+0-33+6 weeks', '55 infants at 32+0 ± 1.4 weeks (range 28+2-33+6), with birth weight 1760 g ± 449 g (range 885-2822']","['care provided in skin-to-skin contact with a parent or on a resuscitaire and later in an incubator or bed during the first postnatal hour', 'skin-to-skin contact (SSC', 'Immediate skin-to-skin contact']","['Infant body temperature', 'Mean body temperature', 'respiratory support or breastfeeding']","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0021178', 'cui_str': 'Incubators'}, {'cui': 'C0237868', 'cui_str': 'Separation'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with (contextual qualifier) (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0021178', 'cui_str': 'Incubators'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]",,0.0607447,"No differences between groups were seen in respiratory support or breastfeeding.
","[{'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Linnér', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Stina', 'Initials': 'S', 'LastName': 'Klemming', 'Affiliation': 'Neonatal Unit, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Sundberg', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Siri', 'Initials': 'S', 'LastName': 'Lilliesköld', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Westrup', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Wibke', 'Initials': 'W', 'LastName': 'Jonas', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Béatrice', 'Initials': 'B', 'LastName': 'Skiöld', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15062']
3488,31822212,"The Long-Term Benefits of a Multicomponent Physical Activity Program to Body Composition, Muscle Strength, Cardiorespiratory Capacity, and Bone Mineral Density in a Group of Nonagenarians.","Promotion of physical activity among older adults is considered to be one of the main actions that can result in more successful aging. Currently, there are few studies focusing on the effects of long-duration physical activity interventions in older adults. This study examined the effects of an 8-month multicomponent intervention on cardiorespiratory capacity (6-minute walking test), body composition (body-mass index), muscle strength (handgrip and knee extension), and bone mineral density (femoral neck) in a group of nonagenarians. A secondary aim was to determine the impact of the program according to the participant's way of life (institutionalized vs. community dwelling). A total of 14 institutionalized nonagenarians (years: 93.1 ± 1.6; female: 100%) and 16 community-dwelling nonagenarians (years: 93.1 ± 1.6; female: 75%) participated in this study. Our analysis suggested that the multicomponent program significantly improved the levels of strength in handgrip and leg extension in all participants. Intergroup analysis showed that the changes experienced were greater in community-dwelling people. Improvements in the cardiorespiratory capacity of older adults-more distance walked in 6 minutes-who were living in the nursing home (mean distance traveled: 238.5 ± 96.0 vs. 250.7 ± 99.0 m) were observed. Our findings found that an 8-month, multicomponent intervention program results in significant improvements in the levels of strength (handgrip and knee extension) in nonagenarians. This effect is greater in community-dwelling people.",2020,Our analysis suggested that the multicomponent program significantly improved the levels of strength in handgrip and leg extension in all participants.,"['A total of 14 institutionalized nonagenarians (years: 93.1\u2009±\u20091.6; female: 100%) and 16 community-dwelling nonagenarians (years: 93.1\u2009±\u20091.6; female: 75%) participated in this study', 'older adults', 'community-dwelling people', ""participant's way of life (institutionalized vs. community dwelling""]","['Multicomponent Physical Activity Program', 'multicomponent intervention']","['Body Composition, Muscle Strength, Cardiorespiratory Capacity, and Bone Mineral Density', 'levels of strength in handgrip and leg extension', 'cardiorespiratory capacity (6-minute walking test), body composition (body-mass index), muscle strength (handgrip and knee extension), and bone mineral density (femoral neck', 'levels of strength (handgrip and knee extension']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517508', 'cui_str': '1.6 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0028296', 'cui_str': 'Nonagenarians'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0562359', 'cui_str': 'Institutionalized (finding)'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}]",,0.0207811,Our analysis suggested that the multicomponent program significantly improved the levels of strength in handgrip and leg extension in all participants.,"[{'ForeName': 'Jose Maria', 'Initials': 'JM', 'LastName': 'Cancela', 'Affiliation': 'HealthyFit Research Group, Department of Special Didactics, Faculty of Education and Sport Sciences, University of Vigo, Pontevedra, Spain.'}, {'ForeName': 'Carlos Ayán', 'Initials': 'CA', 'LastName': 'Perez', 'Affiliation': 'HealthyFit Research Group, Department of Special Didactics, Faculty of Education and Sport Sciences, University of Vigo, Pontevedra, Spain.'}, {'ForeName': 'Luis Paulo', 'Initials': 'LP', 'LastName': 'Rodrigues', 'Affiliation': 'Escola Superior Desporto e Lazer de Melgaço, Instituto Politécnico de Viana do Castelo, Viana do Castelo, Portugal.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Bezerra', 'Affiliation': 'Research Center in Sports Sciences Health and Human Development (CIDESD), Vila Real, Portugal.'}]",Rejuvenation research,['10.1089/rej.2019.2195']
3489,32169887,"Dietary Advanced Glycation End-products (AGE) and Risk of Breast Cancer in the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO).","Advanced glycation end-products (AGEs) are implicated in the pathogenesis of several chronic diseases including cancer. AGEs are produced endogenously but can also be consumed from foods. AGE formation in food is accelerated during cooking at high temperatures. Certain high fat or highly processed foods have high AGE values. The objective of the study was to assign and quantify N ϵ -carboxymethyl-lysine (CML)-AGE content in food and investigate the association between dietary AGE intake and breast cancer risk in the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial. The study included women enrolled in the intervention arm who were cancer-free at baseline and completed a baseline questionnaire and food frequency questionnaire (DQX). CML-AGE values were assigned and quantified to foods in the DQX using a published AGE database. Cox proportional hazards models were used to estimate the hazard ratios (HR) and 95% confidence intervals (CI) of breast cancer among all women, and stratified by race/ethnicity, invasiveness of disease, and hormone receptor status. After a median 11.5 years of follow-up, 1,592 women were diagnosed with breast cancer. Higher CML-AGE intake was associated with increased risk of breast cancer among all women (HR Q5VSQ1 , 1.30; 95% CI, 1.04-1.62;  P   trend  = 0.04) and in non-Hispanic white women (HR T3VST1 , 1.21; 95% CI, 1.02-1.44). Increased CML-AGE intake was associated with increased risk of  in situ  (HR T3VST1 , 1.49; 95% CI, 1.11-2.01) and hormone receptor-positive (HR T3VST1 , 1.24; 95% CI, 1.01-1.53) breast cancers. In conclusion, high intake of dietary AGE may contribute to increased breast cancer.",2020,"Higher CML-AGE intake was associated with increased risk of breast cancer among all women (HRQ5 VS Q1:1.30, 95% CI: 1.04-1.62; P-trend: 0.04) and in non-Hispanic white women (HRT3 VS T1: 1.21, 95% CI: 1.02-1.44).","['1,592 women were diagnosed with breast cancer', 'women enrolled in the intervention arm who were cancer-free at baseline and completed a']",[],"['hormone receptor positive (HRT3 VS T1', 'Increased CML-AGE intake', 'risk of breast cancer', 'baseline questionnaire and food frequency questionnaire (DQX']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",[],"[{'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",1592.0,0.0530889,"Higher CML-AGE intake was associated with increased risk of breast cancer among all women (HRQ5 VS Q1:1.30, 95% CI: 1.04-1.62; P-trend: 0.04) and in non-Hispanic white women (HRT3 VS T1: 1.21, 95% CI: 1.02-1.44).","[{'ForeName': 'Omonefe O', 'Initials': 'OO', 'LastName': 'Omofuma', 'Affiliation': 'Department of Epidemiology and Biostatistics, Arnold School of Public Health, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Turner', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Lindsay L', 'Initials': 'LL', 'LastName': 'Peterson', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Anwar T', 'Initials': 'AT', 'LastName': 'Merchant', 'Affiliation': 'Department of Epidemiology and Biostatistics, Arnold School of Public Health, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'Jiajia', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology and Biostatistics, Arnold School of Public Health, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Steck', 'Affiliation': 'Department of Epidemiology and Biostatistics, Arnold School of Public Health, University of South Carolina, Columbia, South Carolina. stecks@mailbox.sc.edu.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-19-0457']
3490,32128938,"Illness uncertainty, coping, and quality of life among patients with prostate cancer.","OBJECTIVE


Illness uncertainty is a significant source of psychological distress that affects cancer patients' quality of life (QOL). Mishel's uncertainty in illness theory (UIT) proposes that illness uncertainty influences an individual's use of coping strategies, and directly and indirectly influences their QOL. This study tested the relationships depicted in the adapted UIT in cancer patients.
METHODS


This cross-sectional study is a secondary analysis of the baseline data from a randomized clinical trial (N = 263 prostate cancer patients). Patients were diagnosed with localized (64.6%), biochemical recurrent (12.6%), or advanced (22.8%) prostate cancer. Uncertainty, coping (avoidant and active coping strategies), and QOL (physical and mental well-being) were measured using the Mishel's uncertainty of illness scale, Brief COPE, and the Medical Outcomes Study 12-item short form (SF-12), respectively. We used path analysis to achieve the research aim.
RESULTS


Patients' illness uncertainty directly, negatively influenced their physical well-being (P < .001) and mental well-being (P < .05). Patients' illness uncertainty was positively related to their avoidant coping strategies (P < .001). Patients' active and avoidant coping strategies influenced their mental well-being (P < .001). Uncertainty also negatively influenced mental well-being through avoidant coping strategies. The model had excellent fit to the data.
CONCLUSIONS


Our findings have indicated the potential of improving QOL by decreasing illness uncertainty and reducing avoidant coping strategies. Future research is needed to better understand the complex relationships between illness uncertainty, coping strategies, and domains of QOL among patients with different types of cancer using longitudinal research.",2020,"RESULTS


Patients' illness uncertainty directly, negatively influenced their physical well-being (P < .001) and mental well-being (P < .05).","['patients with prostate cancer', 'Patients were diagnosed with localized (64.6%), biochemical recurrent (12.6%), or advanced (22.8%) prostate cancer', 'cancer patients', '263 prostate cancer patients']",[],"['Uncertainty, coping (avoidant and active coping strategies), and QOL (physical and mental well-being', 'Illness uncertainty, coping, and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C4517545', 'cui_str': 'Twelve point six'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C4517671', 'cui_str': '263'}]",[],"[{'cui': 'C0087130', 'cui_str': 'Uncertainty'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0424578', 'cui_str': 'Sense of well-being'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0034380'}]",263.0,0.0364443,"RESULTS


Patients' illness uncertainty directly, negatively influenced their physical well-being (P < .001) and mental well-being (P < .05).","[{'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Guan', 'Affiliation': 'School of Social Work, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Sheila Judge', 'Initials': 'SJ', 'LastName': 'Santacroce', 'Affiliation': 'School of Nursing, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Ding-Geng', 'Initials': 'DG', 'LastName': 'Chen', 'Affiliation': 'School of Social Work, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Lixin', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'School of Nursing, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}]",Psycho-oncology,['10.1002/pon.5372']
3491,31270506,Investigation of the role of typhoid toxin in acute typhoid fever in a human challenge model.,"Salmonella Typhi is a human host-restricted pathogen that is responsible for typhoid fever in approximately 10.9 million people annually 1 . The typhoid toxin is postulated to have a central role in disease pathogenesis, the establishment of chronic infection and human host restriction 2-6 . However, its precise role in typhoid disease in humans is not fully defined. We studied the role of typhoid toxin in acute infection using a randomized, double-blind S. Typhi human challenge model 7 . Forty healthy volunteers were randomized (1:1) to oral challenge with 10 4  colony-forming units of wild-type or an isogenic typhoid toxin deletion mutant (TN) of S. Typhi. We observed no significant difference in the rate of typhoid infection (fever ≥38 °C for ≥12 h and/or S. Typhi bacteremia) between participants challenged with wild-type or TN S. Typhi (15 out of 21 (71%) versus 15 out of 19 (79%); P = 0.58). The duration of bacteremia was significantly longer in participants challenged with the TN strain compared with wild-type (47.6 hours (28.9-97.0) versus 30.3(3.6-49.4); P ≤ 0.001). The clinical syndrome was otherwise indistinguishable between wild-type and TN groups. These data suggest that the typhoid toxin is not required for infection and the development of early typhoid fever symptoms within the context of a human challenge model. Further clinical data are required to assess the role of typhoid toxin in severe disease or the establishment of bacterial carriage.",2019,The duration of bacteremia was significantly longer in participants challenged with the TN strain compared with wild-type (47.6 hours (28.9-97.0) versus 30.3(3.6-49.4); P ≤ 0.001).,['Forty healthy volunteers'],"['oral challenge with 10 4  colony-forming units of wild-type or an isogenic typhoid toxin deletion mutant (TN) of S. Typhi', 'typhoid toxin']","['rate of typhoid infection', 'duration of bacteremia']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit (qualifier value)'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0041466', 'cui_str': 'Salmonella typhi Infection'}, {'cui': 'C4522020', 'cui_str': 'Toxin'}, {'cui': 'C1442161', 'cui_str': 'Deletion (morphologic abnormality)'}]","[{'cui': 'C0041466', 'cui_str': 'Salmonella typhi Infection'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}]",40.0,0.136122,The duration of bacteremia was significantly longer in participants challenged with the TN strain compared with wild-type (47.6 hours (28.9-97.0) versus 30.3(3.6-49.4); P ≤ 0.001).,"[{'ForeName': 'Malick M', 'Initials': 'MM', 'LastName': 'Gibani', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK. malick.gibani@paediatrics.ox.ac.uk.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Jones', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Barton', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Celina', 'Initials': 'C', 'LastName': 'Jin', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Meek', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Camara', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Ushma', 'Initials': 'U', 'LastName': 'Galal', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Clinical Trials Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Heinz', 'Affiliation': 'Wellcome Sanger Institute, Wellcome Genome Campus, Hinxton, UK.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Rosenberg-Hasson', 'Affiliation': 'Human Immune Monitoring Center, Institute for Immunity, Transplantation and Infection, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Gerlinde', 'Initials': 'G', 'LastName': 'Obermoser', 'Affiliation': 'Human Immune Monitoring Center, Institute for Immunity, Transplantation and Infection, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Campbell', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Black', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Thomaides-Brears', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Darlow', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Dold', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Silva-Reyes', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Blackwell', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Lara-Tejero', 'Affiliation': 'Department of Microbial Pathogenesis, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Xuyao', 'Initials': 'X', 'LastName': 'Jiao', 'Affiliation': 'Department of Microbial Pathogenesis, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Stack', 'Affiliation': 'Department of Microbial Pathogenesis, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Christoph J', 'Initials': 'CJ', 'LastName': 'Blohmke', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hill', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Angus', 'Affiliation': 'Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Dougan', 'Affiliation': 'Wellcome Sanger Institute, Wellcome Genome Campus, Hinxton, UK.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Galán', 'Affiliation': 'Department of Microbial Pathogenesis, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Pollard', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}]",Nature medicine,['10.1038/s41591-019-0505-4']
3492,32011334,"Intraabdominal Pressure Targeted Positive End-expiratory Pressure during Laparoscopic Surgery: An Open-label, Nonrandomized, Crossover, Clinical Trial.","BACKGROUND


Pneumoperitoneum for laparoscopic surgery is associated with a rise of driving pressure. The authors aimed to assess the effects of positive end-expiratory pressure (PEEP) on driving pressure at varying intraabdominal pressure levels. It was hypothesized that PEEP attenuates pneumoperitoneum-related rises in driving pressure.
METHODS


Open-label, nonrandomized, crossover, clinical trial in patients undergoing laparoscopic cholecystectomy. ""Targeted PEEP"" (2 cm H2O above intraabdominal pressure) was compared with ""standard PEEP"" (5 cm H2O), with respect to the transpulmonary and respiratory system driving pressure at three predefined intraabdominal pressure levels, and each patient was ventilated with two levels of PEEP at the three intraabdominal pressure levels in the same sequence. The primary outcome was the difference in transpulmonary driving pressure between targeted PEEP and standard PEEP at the three levels of intraabdominal pressure.
RESULTS


Thirty patients were included and analyzed. Targeted PEEP was 10, 14, and 17 cm H2O at intraabdominal pressure of 8, 12, and 15 mmHg, respectively. Compared to standard PEEP, targeted PEEP resulted in lower median transpulmonary driving pressure at intraabdominal pressure of 8 mmHg (7 [5 to 8] vs. 9 [7 to 11] cm H2O; P = 0.010; difference 2 [95% CI 0.5 to 4 cm H2O]); 12 mmHg (7 [4 to 9] vs.10 [7 to 12] cm H2O; P = 0.002; difference 3 [1 to 5] cm H2O); and 15 mmHg (7 [6 to 9] vs.12 [8 to 15] cm H2O; P < 0.001; difference 4 [2 to 6] cm H2O). The effects of targeted PEEP compared to standard PEEP on respiratory system driving pressure were comparable to the effects on transpulmonary driving pressure, though respiratory system driving pressure was higher than transpulmonary driving pressure at all intraabdominal pressure levels.
CONCLUSIONS


Transpulmonary driving pressure rises with an increase in intraabdominal pressure, an effect that can be counterbalanced by targeted PEEP. Future studies have to elucidate which combination of PEEP and intraabdominal pressure is best in term of clinical outcomes.",2020,"The effects of targeted PEEP compared to standard PEEP on respiratory system driving pressure were comparable to the effects on transpulmonary driving pressure, though respiratory system driving pressure was higher than transpulmonary driving pressure at all intraabdominal pressure levels.
","['patients undergoing', 'Thirty patients were included and analyzed']","['positive end-expiratory pressure (PEEP', 'Laparoscopic Surgery', 'laparoscopic cholecystectomy. ', 'standard PEEP', 'PEEP']","['transpulmonary driving pressure between targeted PEEP and standard PEEP at the three levels of intraabdominal pressure', 'Intraabdominal Pressure', 'median transpulmonary driving pressure at intraabdominal pressure', 'intraabdominal pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C3494516', 'cui_str': 'Positive end expiratory pressure (observable entity)'}, {'cui': 'C0863179', 'cui_str': 'Peeping'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0442377', 'cui_str': 'Transpulmonary artery approach (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0863179', 'cui_str': 'Peeping'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0231901', 'cui_str': 'Intraabdominal pressure (observable entity)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",30.0,0.141456,"The effects of targeted PEEP compared to standard PEEP on respiratory system driving pressure were comparable to the effects on transpulmonary driving pressure, though respiratory system driving pressure was higher than transpulmonary driving pressure at all intraabdominal pressure levels.
","[{'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Mazzinari', 'Affiliation': 'From the Research Group in Perioperative Medicine (G.M., O.D-C., N.G-G., B.A-M., M.P.A.N.) the Department of Anaesthesiology (G.M., O.D-C., J.M.A.-I., N.G-G., B.A-M., M.P.A.N.) the Department of Hepatobiliopancreatic Surgery (J.L.I., J.M.), Hospital Universitario y Politécnico la Fe, Valencia, Spain the Department of Critical Care Medicine, Hospital Israelita Albert Einstein, São Paulo, Brazil (A.S.N.) the Cardio-Pulmonary Department, Pulmonary Division, Instituto do Coração, Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil (A.S.N.) the Department of Intensive Care and Laboratory of Experimental Intensive Care and Anesthesiology (LEICA), Academic Medical Center, Amsterdam, The Netherlands (A.S.N., M.J.S.) Policlinico San Martino Hospital - Istituto di Ricovero e Cura a Carattere Scientifico for Oncology and Neurosciences, Genoa, Italy (L.B., P.P.) the Department of Surgical Sciences and Integrated Diagnostics, University of Genoa Italy (L.B., P.P.) the Department of Anesthesiology and Intensive Care Therapy, Pulmonary Engineering Group, Technische Universität Dresden, Dresden, Germany (M.G.d.A.) the Mahidol-Oxford Tropical Medicine Research Unit, Mahidol University, Bangkok, Thailand (M.J.S.) the Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom (M.J.S.).'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Diaz-Cambronero', 'Affiliation': ''}, {'ForeName': 'Jose Miguel', 'Initials': 'JM', 'LastName': 'Alonso-Iñigo', 'Affiliation': ''}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Garcia-Gregorio', 'Affiliation': ''}, {'ForeName': 'Begoña', 'Initials': 'B', 'LastName': 'Ayas-Montero', 'Affiliation': ''}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Ibañez', 'Affiliation': ''}, {'ForeName': 'Ary', 'Initials': 'A', 'LastName': 'Serpa Neto', 'Affiliation': ''}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Ball', 'Affiliation': ''}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Gama de Abreu', 'Affiliation': ''}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pelosi', 'Affiliation': ''}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Maupoey', 'Affiliation': ''}, {'ForeName': 'Maria Pilar', 'Initials': 'MP', 'LastName': 'Argente Navarro', 'Affiliation': ''}, {'ForeName': 'Marcus J', 'Initials': 'MJ', 'LastName': 'Schultz', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003146']
3493,32130261,Meropenem vs standard of care for treatment of neonatal late onset sepsis (NeoMero1): A randomised controlled trial.,"BACKGROUND


The early use of broad-spectrum antibiotics remains the cornerstone for the treatment of neonatal late onset sepsis (LOS). However, which antibiotics should be used is still debatable, as relevant studies were conducted more than 20 years ago, recruited in single centres or countries, evaluated antibiotics not in clinical use anymore and had variable inclusion/exclusion criteria and outcome measures. Moreover, antibiotic-resistant bacteria have become a major problem in many countries worldwide. We hypothesized that efficacy of meropenem as a broad-spectrum antibiotic is superior to standard of care regimens (SOC) in empiric treatment of LOS and aimed to compare meropenem to SOC in infants aged <90 days with LOS.
METHODS AND FINDINGS


NeoMero-1 was a randomized, open-label, phase III superiority trial conducted in 18 neonatal units in 6 countries. Infants with post-menstrual age (PMA) of ≤44 weeks with positive blood culture and one, or those with negative culture and at least with two predefined clinical and laboratory signs suggestive of LOS, or those with PMA >44 weeks meeting the Goldstein criteria of sepsis, were randomized in a 1:1 ratio to receive meropenem or one of the two SOC regimens (ampicillin+gentamicin or cefotaxime+gentamicin) chosen by each site prior to the start of the study for 8-14 days. The primary outcome was treatment success (survival, no modification of allocated therapy, resolution/improvement of clinical and laboratory markers, no need of additional antibiotics and presumed/confirmed eradication of pathogens) at test-of-cure visit (TOC) in full analysis set. Stool samples were tested at baseline and Day 28 for meropenem-resistant Gram-negative organisms (CRGNO). The primary analysis was performed in all randomised patients and in patients with culture confirmed LOS. Proportions of participants with successful outcome were compared by using a logistic regression model adjusted for the stratification factors. From September 3, 2012 to November 30th 2014, total of 136 patients (instead of planned 275) in each arm were randomized; 140 (52%) were culture positive. Successful outcome at TOC was achieved in 44/136 (32%) in the meropenem arm vs. 31/135 (23%) in the SOC arm (p = 0.087). The respective numbers in patients with positive cultures were 17/63 (27%) vs. 10/77 (13%) (p = 0.022). The main reason of failure was modification of allocated therapy. Treatment emergent adverse events occurred in 72% and serious adverse events in 17% of patients, the Day 28 mortality was 6%. Cumulative acquisition of CRGNO by Day 28 occurred in 4% of patients in the meropenem and 12% in the SOC arm (p = 0.052).
CONCLUSIONS


Within this study population, we found no evidence that meropenem was superior to SOC in terms of success at TOC, short term hearing disturbances, safety or mortality were similar in both treatment arms but the study was underpowered to detect the planned effect. Meropenem treatment did not select for colonization with CRGNOs. We suggest that meropenem as broad-spectrum antibiotic should be reserved for neonates who are more likely to have Gram-negative LOS, especially in NICUs where microorganisms producing extended spectrum- and AmpC type beta-lactamases are circulating.",2020,"Within this study population, we found no evidence that meropenem was superior to SOC in terms of success at TOC, short term hearing disturbances, safety or mortality were similar in both treatment arms but the study was underpowered to detect the planned effect.","['neonatal late onset sepsis (LOS', 'neonatal late onset sepsis (NeoMero1', '18 neonatal units in 6 countries', 'From September 3, 2012 to November 30th 2014, total of 136 patients (instead of planned 275) in each arm were randomized; 140 (52%) were culture positive', 'Infants with post-menstrual age (PMA) of ≤44 weeks with positive blood culture and one, or those with negative culture and at least with two predefined clinical and laboratory signs suggestive of LOS, or those with PMA >44 weeks meeting the Goldstein criteria of sepsis', 'infants aged <90 days with LOS']","['meropenem or one of the two SOC regimens (ampicillin+gentamicin or cefotaxime+gentamicin', 'meropenem', 'Meropenem']","['serious adverse events', 'hearing disturbances, safety or mortality', 'TOC', 'adverse events', 'treatment success (survival, no modification of allocated therapy, resolution/improvement of clinical and laboratory markers, no need of additional antibiotics and presumed/confirmed eradication of pathogens) at test-of-cure visit (TOC', 'Cumulative acquisition of CRGNO']","[{'cui': 'C1096721', 'cui_str': 'Neonatal Late-Onset Sepsis'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0159125', 'cui_str': 'Culture positive'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0740299', 'cui_str': 'Blood culture positive for microorganism'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0332299', 'cui_str': 'Suggestive of (attribute)'}, {'cui': 'C0048451', 'cui_str': 'p-methoxy-alpha-methylphenethylamine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0439087', 'cui_str': '<90 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0066005', 'cui_str': 'meropenem'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018767', 'cui_str': 'Audition'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0162490', 'cui_str': 'Markers, Laboratory'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",136.0,0.46864,"Within this study population, we found no evidence that meropenem was superior to SOC in terms of success at TOC, short term hearing disturbances, safety or mortality were similar in both treatment arms but the study was underpowered to detect the planned effect.","[{'ForeName': 'Irja', 'Initials': 'I', 'LastName': 'Lutsar', 'Affiliation': 'Institute of Translational Medicine, University of Tartu, Tartu, Estonia.'}, {'ForeName': 'Corine', 'Initials': 'C', 'LastName': 'Chazallon', 'Affiliation': 'INSERM SC10-US19, Villejuif, France.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Trafojer', 'Affiliation': ""Women's and Children's Health Department, Neonatal Intensive Care Unit, Azienda Ospedaliera-University of Padua, Padua, Italy.""}, {'ForeName': 'Vincent Meiffredy', 'Initials': 'VM', 'LastName': 'de Cabre', 'Affiliation': 'INSERM SC10-US19, Villejuif, France.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Auriti', 'Affiliation': ""Department of Neonatology, Neonatal Intensive Care Unit, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.""}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Bertaina', 'Affiliation': ""University Department of Paediatrics, Immunological and Infectious Disease Unit, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.""}, {'ForeName': 'Francesca Ippolita', 'Initials': 'FI', 'LastName': 'Calo Carducci', 'Affiliation': ""University Department of Paediatrics, Immunological and Infectious Disease Unit, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.""}, {'ForeName': 'Fuat Emre', 'Initials': 'FE', 'LastName': 'Canpolat', 'Affiliation': 'Sağlık Bilimleri Üniversitesi, Zekai Tahir Burak Kadın Sağlığı Eğitim ve Araştırma Hastanesi, Neonatoloji Kliniği, Ankara, Turkey.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Esposito', 'Affiliation': ""Pediatric Highly Intensive Care Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy.""}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Fournier', 'Affiliation': 'INSERM SC10-US19, Villejuif, France.'}, {'ForeName': 'Maarja', 'Initials': 'M', 'LastName': 'Hallik', 'Affiliation': ""Department of Intensive Care, Tallinn Children's Hospital, Tallinn, Estonia.""}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Heath', 'Affiliation': ""Paediatric Infectious Disease Research Group, Institute for Infection and Immunity, St George's University of London, London, United Kingdom.""}, {'ForeName': 'Mari-Liis', 'Initials': 'ML', 'LastName': 'Ilmoja', 'Affiliation': 'Institute of Translational Medicine, University of Tartu, Tartu, Estonia.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Iosifidis', 'Affiliation': '3rd Department of Pediatrics, Faculty of Medicine, Infectious Diseases Unit, Aristotle University School of Health Sciences, Hippokration Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Kuznetsova', 'Affiliation': 'Tartu University Hospital, Clinic of Anaesthesiology and Intensive Care, Tartu, Estonia.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Meyer', 'Affiliation': 'INSERM SC10-US19, Villejuif, France.'}, {'ForeName': 'Tuuli', 'Initials': 'T', 'LastName': 'Metsvaht', 'Affiliation': 'Institute of Translational Medicine, University of Tartu, Tartu, Estonia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Mitsiakos', 'Affiliation': '2nd Department of Neonatology, Faculty of Medicine, Aristotle University School of Health Sciences, Papageorgiou Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Zoi Dorothea', 'Initials': 'ZD', 'LastName': 'Pana', 'Affiliation': '3rd Department of Pediatrics, Faculty of Medicine, Infectious Diseases Unit, Aristotle University School of Health Sciences, Hippokration Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Mosca', 'Affiliation': ""Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy.""}, {'ForeName': 'Lorenza', 'Initials': 'L', 'LastName': 'Pugni', 'Affiliation': ""Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy.""}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Roilides', 'Affiliation': '3rd Department of Pediatrics, Faculty of Medicine, Infectious Diseases Unit, Aristotle University School of Health Sciences, Hippokration Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Rossi', 'Affiliation': ""University Department of Paediatrics, Immunological and Infectious Disease Unit, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.""}, {'ForeName': 'Kosmas', 'Initials': 'K', 'LastName': 'Sarafidis', 'Affiliation': '1st Department of Neonatology, Faculty of Medicine, Aristotle University School of Health Sciences, Hippokration Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Sanchez', 'Affiliation': 'Hospital Universitario Infantil LA PAZ- H. Carlos III, Madrid, Spain.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sharland', 'Affiliation': ""Paediatric Infectious Disease Research Group, Institute for Infection and Immunity, St George's University of London, London, United Kingdom.""}, {'ForeName': 'Vytautas', 'Initials': 'V', 'LastName': 'Usonis', 'Affiliation': 'Faculty of Medicine, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Adilia', 'Initials': 'A', 'LastName': 'Warris', 'Affiliation': 'MRC Centre for Medical Mycology, Institute of Medical Sciences, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Aboulker', 'Affiliation': 'INSERM SC10-US19, Villejuif, France.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Giaquinto', 'Affiliation': ""Department of Women's and Children's Health, University of Padova, Padova, Italy.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0229380']
3494,32165251,"A randomized, placebo-controlled, phase II study of obeticholic acid for primary sclerosing cholangitis.","BACKGROUND & AIMS


Primary sclerosing cholangitis (PSC) is a rare, cholestatic liver disease with no currently approved therapies. Obeticholic acid (OCA) is a potent farnesoid X receptor (FXR) agonist approved for the treatment of primary biliary cholangitis. We investigated the efficacy and safety of OCA in patients with PSC.
METHODS


AESOP was a phase II, randomized, double-blind, placebo-controlled, dose-finding study. Eligible patients were 18 to 75 years of age with a diagnosis of PSC and serum alkaline phosphatase (ALP) ≥2× the upper limit of normal (ULN) and total bilirubin <2.5× ULN. Patients were randomized 1:1:1 to receive placebo, OCA 1.5-3.0 mg, or OCA 5-10 mg once daily for a 24-week, double-blind phase followed by a 2-year, long-term safety extension (LTSE). Primary endpoints were change in ALP from baseline to week 24, and safety.
RESULTS


The intent-to-treat population comprised 76 patients randomized to placebo (n = 25), OCA 1.5-3.0 mg (n = 25), and OCA 5-10 mg (n = 26). At week 24, serum ALP was significantly reduced with OCA 5-10 mg vs. placebo (least-square [LS] mean difference = -83.4 [SE = 40.3] U/L; 95% CI -164.28 to -2.57; p = 0.043). Serum ALP was not significantly reduced with OCA 1.5-3.0 mg vs. placebo at week 24 (LS mean [SE] difference = -78.29 [41.81] U/L; 95% CI -162.08 to 5.50; p = 0.067). Total bilirubin remained comparable to baseline in all groups. The most common treatment-emergent adverse event was dose-related pruritus (placebo 46%; OCA 1.5-3.0 mg 60%; OCA 5-10 mg 67%). Reductions in ALP were maintained during the LTSE, and no new safety signals emerged.
CONCLUSIONS


Treatment with OCA 5-10 mg reduced serum ALP in patients with PSC. Mild to moderate dose-related pruritus was the most common adverse event.
REGISTRATION


ClinicalTrials.gov: NCT02177136; EudraCT: 2014-002205-38.
LAY SUMMARY


Primary sclerosing cholangitis (PSC) is a long-term disease that damages the bile ducts in the liver over time. In the AESOP clinical study in patients with PSC, obeticholic acid reduced serum alkaline phosphatase (a potential marker of disease severity) during an initial 24-week treatment period. The result was sustained during the 2-year, long-term extension of the study. The most common side effect of obeticholic acid in the study was itchy skin, which is consistent with earlier clinical studies.",2020,"At week 24, serum ALP was significantly reduced with OCA 5-10 mg vs. placebo: least-square (LS) mean difference = ‒83.4","['primary biliary cholangitis', 'primary sclerosing cholangitis', 'Eligible patients were 18 to 75 years of age with a diagnosis of PSC and serum alkaline phosphatase (ALP', 'patients with PSC']","['Obeticholic acid (OCA', 'OCA 1.5-3 mg (n=25), and OCA', 'obeticholic acid', 'placebo, OCA 1.5-3 mg, or OCA 5-10 mg once daily for a 24-week double-blind phase followed by a 2-year, long-term safety extension (LTSE', 'placebo', 'OCA']","['Serum ALP', 'serum ALP', 'efficacy and safety', 'change in ALP from baseline to week 24, and safety', 'Reductions in ALP', 'Total bilirubin']","[{'cui': 'C0008312', 'cui_str': 'Primary Billiary Cholangitis'}, {'cui': 'C0566602', 'cui_str': 'Primary sclerosing cholangitis (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0036776', 'cui_str': 'Serum alkaline phosphatase measurement'}]","[{'cui': 'C1143018', 'cui_str': 'obeticholic acid'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0201913', 'cui_str': 'Bilirubin, total measurement (procedure)'}]",,0.685916,"At week 24, serum ALP was significantly reduced with OCA 5-10 mg vs. placebo: least-square (LS) mean difference = ‒83.4","[{'ForeName': 'Kris V', 'Initials': 'KV', 'LastName': 'Kowdley', 'Affiliation': 'Liver Institute Northwest, Seattle, WA, USA. Electronic address: kkowdley@liverinstitutenw.org.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Vuppalanchi', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Levy', 'Affiliation': 'Division of Hepatology, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Annarosa', 'Initials': 'A', 'LastName': 'Floreani', 'Affiliation': 'Università di Padova, Padova, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Andreone', 'Affiliation': 'SMECHIMAI Department, Università di Modena e Reggio-Emilia, Modena, Italy.'}, {'ForeName': 'Nicholas F', 'Initials': 'NF', 'LastName': 'LaRusso', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Roshan', 'Initials': 'R', 'LastName': 'Shrestha', 'Affiliation': 'Department of Transplantation, Piedmont Transplant Institute, Atlanta, GA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Trotter', 'Affiliation': 'Division of Transplant Hepatology, Baylor University, Dallas, TX, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Goldberg', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Rushbrook', 'Affiliation': 'Faculty of Medicine and Health Sciences, Norwich Medical School, Norwich, UK.'}, {'ForeName': 'Gideon M', 'Initials': 'GM', 'LastName': 'Hirschfield', 'Affiliation': 'Toronto Centre for Liver Disease, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schiano', 'Affiliation': 'Recanati/Miller Transplantation Institute/Division of Liver Diseases, The Mount Sinai Medical Center, New York, NY, USA.'}, {'ForeName': 'Yuying', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'Intercept Pharmaceuticals, Inc., San Diego, CA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pencek', 'Affiliation': 'Intercept Pharmaceuticals, Inc., San Diego, CA, USA.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'MacConell', 'Affiliation': 'Intercept Pharmaceuticals, Inc., San Diego, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shapiro', 'Affiliation': 'Intercept Pharmaceuticals, Inc., San Diego, CA, USA.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Bowlus', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of California, Davis, Sacramento, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of hepatology,['10.1016/j.jhep.2020.02.033']
3495,31959609,"HEV study protocol : design of a cluster-randomised, blinded trial to assess the safety, immunogenicity and effectiveness of the hepatitis E vaccine HEV 239 (Hecolin) in women of childbearing age in rural Bangladesh.","INTRODUCTION


Hepatitis E virus (HEV) is a leading cause of acute viral hepatitis in the developing world and is a public health problem, in particular among pregnant women, where it may lead to severe or fatal complications. A recombinant HEV vaccine, 239 (Hecolin; Xiamen Innovax Biotech, Xiamen, China), is licensed in China, but WHO calls for further studies to evaluate the safety and immunogenicity of this vaccine in vulnerable populations, and to evaluate protection in pregnancy. We are therefore conducting a phase IV trial to assess the effectiveness, safety and immunogenicity of the HEV 239 vaccine when given in women of childbearing age in rural Bangladesh, where HEV infection is endemic.
METHODS AND ANALYSIS


Enrolment of a target of approximately 20 000 non-pregnant women, aged 16-39 years, started on 2 October 2017 in Matlab, Bangladesh. Sixty-seven villages were randomised by village at a 1:1 ratio to receive either the HEV vaccine or the control vaccine (hepatitis B vaccine). A 3-dose vaccination series at 0, 1 and 6 months is ongoing, and women are followed up for 24 months. The primary outcome is confirmed HEV disease among pregnant women. After vaccination, participants are requested to report information about clinical hepatitis symptoms. Participants who become pregnant are visited at their homes every 2 weeks to collect information about pregnancy outcome and to screen for clinical hepatitis. All suspected hepatitis cases undergo laboratory testing for diagnostic evaluation. The incidence of confirmed HEV disease among pregnant and non-pregnant women will be compared between the HEV vaccinated and control groups, safety and immunogenicity of the vaccine will also be evaluated.
ETHICS AND DISSEMINATION


The protocol was reviewed and approved by the International Centre for Diarrhoeal Disease Research, Bangladesh Research Review Committee and Ethical Review Committee, and the Directorate General of Drug Administration in Bangladesh, and by the Regional Ethics Committee in Norway. This article is based on the protocol version 2.2 dated 29 June 2017. We will present the results through peer-reviewed publications and at international conferences.
TRIAL REGISTRATION NUMBER


The trial is registered at clinicaltrials.gov with the registry name ""Effectiveness Trial to Evaluate Protection of Pregnant Women by Hepatitis E Vaccine in Bangladesh"" and the identifier NCT02759991.",2020,"The incidence of confirmed HEV disease among pregnant and non-pregnant women will be compared between the HEV vaccinated and control groups, safety and immunogenicity of the vaccine will also be evaluated.
","['pregnant women', 'Sixty-seven villages', 'Enrolment of a target of approximately 20\u2009000 non-pregnant women, aged 16-39 years, started on 2 October 2017 in Matlab, Bangladesh', 'pregnant and non-pregnant women', 'Pregnant Women by Hepatitis E Vaccine in Bangladesh"" and the identifier NCT02759991', 'women of childbearing age in rural Bangladesh', 'women of childbearing age in rural Bangladesh, where HEV infection is endemic']","['hepatitis E vaccine HEV 239 (Hecolin', 'HEV vaccine or the control vaccine (hepatitis B vaccine', 'recombinant HEV vaccine', 'HEV 239 vaccine']","['effectiveness, safety and immunogenicity', 'safety, immunogenicity and effectiveness', 'HEV disease', 'safety and immunogenicity']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0085293', 'cui_str': 'Hepatitis, Water-Borne'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0243130', 'cui_str': 'endemics'}]","[{'cui': 'C0085293', 'cui_str': 'Hepatitis, Water-Borne'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C3529764', 'cui_str': 'HEV 239'}, {'cui': 'C3529763', 'cui_str': 'hecolin'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0062527', 'cui_str': 'Hepatitis B Surface Antigen Vaccine'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",67.0,0.228392,"The incidence of confirmed HEV disease among pregnant and non-pregnant women will be compared between the HEV vaccinated and control groups, safety and immunogenicity of the vaccine will also be evaluated.
","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Zaman', 'Affiliation': 'International Centre for Diarhoeal Disease Resaerch, Dhaka, Bangladesh kzaman@icddrb.org.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Dudman', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Kathrine', 'Initials': 'K', 'LastName': 'Stene-Johansen', 'Affiliation': 'Division of Infection Control and Environmental Health, Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Firdausi', 'Initials': 'F', 'LastName': 'Qadri', 'Affiliation': 'International Centre for Diarhoeal Disease Resaerch, Dhaka, Bangladesh.'}, {'ForeName': 'Md', 'Initials': 'M', 'LastName': 'Yunus', 'Affiliation': 'International Centre for Diarhoeal Disease Resaerch, Dhaka, Bangladesh.'}, {'ForeName': 'Synne', 'Initials': 'S', 'LastName': 'Sandbu', 'Affiliation': 'Division of Infection Control and Environmental Health, Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Gurley', 'Affiliation': 'International Centre for Diarhoeal Disease Resaerch, Dhaka, Bangladesh.'}, {'ForeName': 'Joakim', 'Initials': 'J', 'LastName': 'Overbo', 'Affiliation': 'Division of Infection Control and Environmental Health, Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Cathinka Halle', 'Initials': 'CH', 'LastName': 'Julin', 'Affiliation': 'Division of Infection Control and Environmental Health, Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Jennifer Lynn', 'Initials': 'JL', 'LastName': 'Dembinski', 'Affiliation': 'Division of Infection Control and Environmental Health, Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Quamrun', 'Initials': 'Q', 'LastName': 'Nahar', 'Affiliation': 'International Centre for Diarhoeal Disease Resaerch, Dhaka, Bangladesh.'}, {'ForeName': 'Anisur', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'International Centre for Diarhoeal Disease Resaerch, Dhaka, Bangladesh.'}, {'ForeName': 'Taufiqur R', 'Initials': 'TR', 'LastName': 'Bhuiyan', 'Affiliation': 'International Centre for Diarhoeal Disease Resaerch, Dhaka, Bangladesh.'}, {'ForeName': 'Mustafizur', 'Initials': 'M', 'LastName': 'Rahman', 'Affiliation': 'International Centre for Diarhoeal Disease Resaerch, Dhaka, Bangladesh.'}, {'ForeName': 'Warda', 'Initials': 'W', 'LastName': 'Haque', 'Affiliation': 'International Centre for Diarhoeal Disease Resaerch, Dhaka, Bangladesh.'}, {'ForeName': 'Jahangir', 'Initials': 'J', 'LastName': 'Khan', 'Affiliation': 'International Centre for Diarhoeal Disease Resaerch, Dhaka, Bangladesh.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Aziz', 'Affiliation': 'International Centre for Diarhoeal Disease Resaerch, Dhaka, Bangladesh.'}, {'ForeName': 'Mahbuba', 'Initials': 'M', 'LastName': 'Khanam', 'Affiliation': 'International Centre for Diarhoeal Disease Resaerch, Dhaka, Bangladesh.'}, {'ForeName': 'Peter Kim', 'Initials': 'PK', 'LastName': 'Streatfield', 'Affiliation': 'International Centre for Diarhoeal Disease Resaerch, Dhaka, Bangladesh.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Clemens', 'Affiliation': 'International Centre for Diarhoeal Disease Resaerch, Dhaka, Bangladesh.'}]",BMJ open,['10.1136/bmjopen-2019-033702']
3496,31964659,Interprofessional education in geriatric medicine: towards best practice. A controlled before-after study of medical and nursing students.,"OBJECTIVES


To investigate nursing and medical students' readiness for interprofessional learning before and after implementing geriatric interprofessional education (IPE), based on problem-based learning (PBL) case scenarios. To define the optimal number of geriatric IPE sessions, the size and the ratio of participants from each profession in the learner groups, the outcomes related to the Kirkpatrick four-level typology of learning evaluation, students' concerns about joint learning and impact of geriatric IPE on these concerns. The study looked at the perception of roles and expertise of the 'other' profession in interprofessional teams, and students' choice of topics for future sessions. Students' expectations, experience, learning points and the influence on the understanding of IP collaboration, as well as their readiness to participate in such education again were investigated.
DESIGN


A controlled before-after study (2014/2015, 2015/2016) with data collected immediately before and after the intervention period. Study includes additional comparison of the results from the intervention with a control group of students. Outcomes were determined with a validated 'Readiness for Interprofessional Learning' questionnaire, to which we added questions with free comments, combining quantitative and qualitative research methods. The teaching sessions were facilitated by experienced practitioners/educators, so each group had both, a clinician (either geratology consultant or registrar) and a senior nurse.
PARTICIPANTS


300 medical, 150 nursing students.
SETTING


Tertiary care university teaching hospital.
RESULTS


Analysis of the returned forms in the intervention group had shown that nursing students scored higher on teamwork and collaboration post-IPE (M=40.78, SD=4.05) than pre-IPE (M=34.59, SD=10.36)-statistically significant. On negative professional identity, they scored lower post-IPE (M=7.21, SD=4.2) than pre-IPE (M=8.46, SD=4.1)-statistically significant. The higher score on positive professional identity post-IPE (M=16.43, SD=2.76) than pre-IPE (M=14.32, SD=4.59) was also statistically significant. Likewise, the lower score on roles and responsibilities post-IPE (M=5.41, SD=1.63) than pre-IPE (M=6.84, SD=2.75).Medical students scored higher on teamwork and collaboration post-IPE (M=36.66, SD=5.1) than pre-IPE (M=32.68, SD=7.4)-statistically significant. Higher positive professional identity post-IPE (M=14.3, SD=3.2) than pre-IPE (M=13.1, SD=4.31)-statistically significant. The lower negative professional identity post-IPE (M=7.6, SD=3.17) than pre-IPE (M=8.36, SD=2.91) was not statistically significant. Nor was the post-IPE difference over roles and responsibilities (M=7.4, SD=1.85), pre-IPE (M=7.85, SD=2.1).In the control group, medical students scored higher for teamwork and collaboration post-IPE (M=36.07, SD=3.8) than pre-IPE (M=33.95, SD=3.37)-statistically significant, same for positive professional identity post-IPE (M=13.74, SD=2.64), pre-IPE (M=12.8, SD=2.29), while negative professional identity post-IPE (M=8.48, SD=2.52), pre-IPE (M=9, SD=2.07), and roles and responsibilities post-IPE (M=7.89, SD=1.69), pre-IPE (M=7.91, SD=1.51) shown no statistically significant differences. Student concerns, enhanced understanding of collaboration and readiness for future joint work were addressed, but not understanding of roles.
CONCLUSIONS


Educators with nursing and medical backgrounds delivered geriatric IPE through case-based PBL. The optimal learner group size was determined. The equal numbers of participants from each profession for successful IPE are not necessary. The IPE delivered by clinicians and senior nurses had an overall positive impact on all participants, but more markedly on nursing students. Surprisingly, it had the same impact on medical students regardless if it was delivered to the mixed groups with nursing students, or to medical students alone. Teaching successfully addressed students' concerns about joint learning and communication and ethics were most commonly suggested topics for the future.",2020,"RESULTS


Analysis of the returned forms in the intervention group had shown that nursing students scored higher on teamwork and collaboration post-IPE (M=40.78, SD=4.05) than pre-IPE (M=34.59, SD=10.36)-statistically significant.","[""nursing and medical students' readiness for interprofessional learning before and after implementing geriatric interprofessional education (IPE"", 'Tertiary care university teaching hospital', 'geriatric medicine', 'medical and nursing students', '300 medical, 150 nursing students']",['Interprofessional education'],"['teamwork and collaboration post-IPE', 'lower negative professional identity post-IPE', 'positive professional identity post-IPE', 'negative professional identity post-IPE', 'pre-IPE', 'higher score on positive professional identity post-IPE']","[{'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",300.0,0.025762,"RESULTS


Analysis of the returned forms in the intervention group had shown that nursing students scored higher on teamwork and collaboration post-IPE (M=40.78, SD=4.05) than pre-IPE (M=34.59, SD=10.36)-statistically significant.","[{'ForeName': 'Sanja', 'Initials': 'S', 'LastName': 'Thompson', 'Affiliation': 'Geratology department, John Radcliffe Hospital, Oxford, UK sanja@doctors.org.uk.'}, {'ForeName': 'Kiloran', 'Initials': 'K', 'LastName': 'Metcalfe', 'Affiliation': 'Medical Sciences Division, University of Oxford, Oxford, UK.'}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Boncey', 'Affiliation': 'Geratology department, John Radcliffe Hospital, Oxford, UK.'}, {'ForeName': 'Clair', 'Initials': 'C', 'LastName': 'Merriman', 'Affiliation': 'Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK.'}, {'ForeName': 'Lorna Catherine', 'Initials': 'LC', 'LastName': 'Flynn', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Gaggandeep Singh', 'Initials': 'GS', 'LastName': 'Alg', 'Affiliation': 'Geratology department, John Radcliffe Hospital, Oxford, UK.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Bothwell', 'Affiliation': 'Geratology department, John Radcliffe Hospital, Oxford, UK.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Forde-Johnston', 'Affiliation': 'Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Puffett', 'Affiliation': 'Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Hardy', 'Affiliation': 'Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Wright', 'Affiliation': 'Geratology department, John Radcliffe Hospital, Oxford, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Beale', 'Affiliation': 'Geratology department, John Radcliffe Hospital, Oxford, UK.'}]",BMJ open,['10.1136/bmjopen-2017-018041']
3497,32057631,Prospective Double-Blinded Randomized Field-Based Clinical Trial of Metoclopramide and Ibuprofen for the Treatment of High Altitude Headache and Acute Mountain Sickness.,"INTRODUCTION


High altitude headache (HAH) and acute mountain sickness (AMS) are common pathologies at high altitudes. There are similarities between AMS and migraine headaches, with nausea being a common symptom. Several studies have shown ibuprofen can be effective for AMS prophylaxis, but few have addressed treatment. Metoclopramide is commonly administered for migraine headaches but has not been evaluated for HAH or AMS. We aimed to evaluate metoclopramide and ibuprofen for treatment of HAH and AMS.
METHODS


We performed a prospective, double-blinded, randomized, field-based clinical trial of metoclopramide and ibuprofen for the treatment of HAH and AMS in 47 adult subjects in the Mount Everest region of Nepal. Subjects received either 400 mg ibuprofen or 10 mg metoclopramide in a 1-time dose. Lake Louise Score (LLS) and visual analog scale of symptoms were measured before and at 30, 60, and 120 min after treatment.
RESULTS


Subjects in both the metoclopramide and ibuprofen arms reported reduced headache severity and nausea compared to pretreatment values at 120 min. The ibuprofen group reported 22 mm reduction in headache and 6 mm reduction in nausea on a 100 mm visual analog scale at 120 min. The metoclopramide group reported 23 mm reduction in headache and 14 mm reduction in nausea. The ibuprofen group reported an average 3.5-point decrease on LLS, whereas the metoclopramide group reported an average 2.0-point decrease on LLS at 120 min.
CONCLUSIONS


Metoclopramide and ibuprofen may be effective alternative treatment options in HAH and AMS, especially for those patients who additionally report nausea.",2020,"RESULTS


Subjects in both the metoclopramide and ibuprofen arms reported reduced headache severity and nausea compared to pretreatment values at 120 min.","['High Altitude Headache and Acute Mountain Sickness', '47 adult subjects in the Mount Everest region of Nepal']","['Metoclopramide and ibuprofen', 'Metoclopramide', 'metoclopramide', 'metoclopramide and ibuprofen', 'Metoclopramide and Ibuprofen', 'ibuprofen', '400 mg ibuprofen']","['LLS', 'headache', 'headache severity and nausea', 'nausea', 'Lake Louise Score (LLS) and visual analog scale of symptoms']","[{'cui': 'C0238617', 'cui_str': 'High altitude (physical force)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0238284', 'cui_str': 'Acute mountain sickness (disorder)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0181909', 'cui_str': 'Mount (physical object)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0027689', 'cui_str': 'Federal Democratic Republic of Nepal'}]","[{'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}]","[{'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0337049', 'cui_str': 'Lakes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",47.0,0.0540356,"RESULTS


Subjects in both the metoclopramide and ibuprofen arms reported reduced headache severity and nausea compared to pretreatment values at 120 min.","[{'ForeName': 'Hillary R', 'Initials': 'HR', 'LastName': 'Irons', 'Affiliation': 'University of Massachusetts, Emergency Medicine, Worcester, MA. Electronic address: Hillary.irons@umassmemorial.org.'}, {'ForeName': 'Renee N', 'Initials': 'RN', 'LastName': 'Salas', 'Affiliation': 'Massachusetts General Hospital, Emergency Medicine / Harvard Medical School, Boston, MA.'}, {'ForeName': 'Salman F', 'Initials': 'SF', 'LastName': 'Bhai', 'Affiliation': ""Brigham and Women's Hospital, Neurology, Boston, MA.""}, {'ForeName': 'W Douglas', 'Initials': 'WD', 'LastName': 'Gregorie', 'Affiliation': 'University of Tennessee, Erlanger Hospital, Emergency Medicine, Chattanooga, TN.'}, {'ForeName': 'N Stuart', 'Initials': 'NS', 'LastName': 'Harris', 'Affiliation': 'University of Massachusetts, Emergency Medicine, Worcester, MA.'}]",Wilderness & environmental medicine,['10.1016/j.wem.2019.11.005']
3498,32077207,"A safety and pharmacodynamics study of temelimab, an antipathogenic human endogenous retrovirus type W envelope monoclonal antibody, in patients with type 1 diabetes.","AIM


To report the first study of temelimab, a monoclonal antibody neutralizing the pathogenic human endogenous retrovirus type W envelope, in patients with type 1 diabetes (T1D).
MATERIALS AND METHODS


This double-blind, placebo-controlled, randomized clinical trial recruited adult patients with T1D within 4 years postdiagnosis and remaining C-peptide secretion. Sixty-four patients were randomized (2:1) to monthly temelimab 6 mg/kg or placebo during 24 weeks followed by a 24-week, open-label extension, during which all patients received temelimab. The primary objective was the safety and tolerability of temelimab. The secondary objective was to assess the pharmacodynamics response such as C-peptide levels, insulin use, HbA1c, hypoglycaemia and autoantibodies.
RESULTS


Temelimab was well tolerated without any group difference in the frequency or severity of adverse events. Concerning exploratory endpoints, there was no difference in the levels of C-peptide, insulin use or HbA1c between treatment groups at weeks 24 and 48. The frequency of hypoglycaemia events was reduced with temelimab (P = 0.0004) at week 24 and the level of anti-insulin antibodies was lower with temelimab (P < 0.01); the other autoantibodies did not differ between groups.
CONCLUSIONS


Temelimab appeared safe in patients with T1D. Pharmacodynamics signals (hypoglycaemia and anti-insulin antibodies) under temelimab were observed. Markers of β-cell functions were not modified by treatment. These results need to be further explored in younger patients with T1D with earlier disease onset.",2020,"The frequency of hypoglycemia events was reduced with temelimab (p=0.0004) at Week 24 and the level of anti-insulin antibodies was lower with temelimab (p<0.01), the other auto-antibodies did not differ between groups.
","['Type 1 Diabetes Patients', 'younger T1D patients with earlier disease onset', 'T1D patients within 4\u2009years post-diagnosis and remaining C-peptide secretion', 'T1D patients']","['Temelimab', 'temelimab', 'placebo', 'temelimab 6 mg/kg or placebo']","['frequency or severity of adverse events', 'level of anti-insulin antibodies', 'levels of C-peptide, insulin use or HbA1c', 'pharmacodynamics (PD) response such as C-peptide levels, insulin use, glycated hemoglobin (HbA1c), hypoglycemia and auto-antibodies', 'frequency of hypoglycemia events', 'Pharmacodynamics signals (hypoglycemia and anti-insulin antibodies', 'safety and tolerability of temelimab']","[{'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0919752', 'cui_str': 'Anti-insulin antibody'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0240016', 'cui_str': 'Insulin used (attribute)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0202100', 'cui_str': 'Insulin C-peptide measurement (procedure)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",64.0,0.0960603,"The frequency of hypoglycemia events was reduced with temelimab (p=0.0004) at Week 24 and the level of anti-insulin antibodies was lower with temelimab (p<0.01), the other auto-antibodies did not differ between groups.
","[{'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Curtin', 'Affiliation': 'GeNeuro SA, Geneva, Switzerland.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Champion', 'Affiliation': 'Department of Clinical Medicine, Faculty of Medicine and Health Sciences, Macquarie University, Macquarie Park, New South Wales, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Davoren', 'Affiliation': 'Gold Coast Hospital, Diabetes and Endocrinology, Southport, Queensland, Australia.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Duke', 'Affiliation': 'Department of Diabetes Endocrinology and Metabolism, Royal North Shore Hospital, St Leonards, New South Wales, Australia.'}, {'ForeName': 'Elif I', 'Initials': 'EI', 'LastName': 'Ekinci', 'Affiliation': 'Department of Medicine, Austin Health and The University of Melbourne, Heidelberg Heights, Victoria, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Gilfillan', 'Affiliation': 'Eastern Clinical Research Unit, Eastern Health and Monash University, Box Hill, Victoria, Australia.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Morbey', 'Affiliation': 'AIM Centre, Merewether, New South Wales, Australia.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Nathow', 'Affiliation': 'Ipswich Research Institute, Ipswich, Queensland, Australia.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': ""O'Moore-Sullivan"", 'Affiliation': 'Mater Hospital, South Brisbane, Queensland, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': ""O'Neal"", 'Affiliation': ""St. Vincent's Hospital, Department of Medicine, Fitzroy, Victoria, Australia.""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Roberts', 'Affiliation': 'Barwon Health, Department of Endocrinology, Geelong, Victoria, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Stranks', 'Affiliation': 'Southern Adelaide Diabetes & Endocrine Services, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Bronwyn', 'Initials': 'B', 'LastName': 'Stuckey', 'Affiliation': 'Keogh Institute for Medical Research, Queen Elizabeth II Medical Centre, Nedlands,, Western Australia, Australia.'}, {'ForeName': 'Parind', 'Initials': 'P', 'LastName': 'Vora', 'Affiliation': 'Division of Medicine, Lyell McEwin Hospital, Elizabeth Vale, South Australia, Australia.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Malpass', 'Affiliation': 'Southern Star Research, Gordon, New South Wales, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lloyd', 'Affiliation': 'Southern Star Research, Gordon, New South Wales, Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Maëstracci-Beard', 'Affiliation': 'GeNeuro SA, Geneva, Switzerland.'}, {'ForeName': 'Bénédicte', 'Initials': 'B', 'LastName': 'Buffet', 'Affiliation': 'GeNeuro SA, Geneva, Switzerland.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Kornmann', 'Affiliation': 'GeNeuro SA, Geneva, Switzerland.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Bernard', 'Affiliation': 'GeNeuro SA, Geneva, Switzerland.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Porchet', 'Affiliation': 'GeNeuro SA, Geneva, Switzerland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Simpson', 'Affiliation': 'Eastern Clinical Research Unit, Eastern Health and Monash University, Box Hill, Victoria, Australia.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14010']
3499,32149854,Abdominoplasty With Scarpa Fascia Preservation: Prospective Comparative Study of Suction Drain Number.,"BACKGROUND


Abdominoplasty is becoming increasingly more common, with seroma being the most frequent complication. Suction drains are used very often as a method to prevent seroma formation, and it has been suggested that techniques using Scarpa fascia preservation and closed-suction drains have lower seroma rates than other approaches. However few studies have addressed parameters that may affect drain efficiency. A prospective comparative study was conducted to determine if applying 2 or 3 closed-suction drains, after an abdominoplasty with Scarpa fascia preservation, has any effect on several outcomes.
METHODS


This was a single-center study conducted from September 2016 to March 2019. Patients were allocated according to choice to 1 of the 2 surgeons involved in the study, each responsible for 1 group: abdominoplasty with Scarpa fascia preservation with 2 closed-suction drains placed postoperatively (group A) or with 3 closed-suction drains (group B). A comparative analysis of selected variables was done between both groups, including time to drain removal, total and daily drain output, duration of hospital stay, emergency department visit, readmission to the hospital, secondary surgical procedure, and incidence of postoperative local and systemic complications.
RESULTS


A total of 73 abdominoplasties with Scarpa fascia preservation were performed in women (group A, 33 patients; group B, 40 patients). General characteristics of group A and B were similar. There were no statistically significant differences between groups in any of the determined variables, namely, main outcomes (total and daily drain output, time to drain removal) or complications (local or systemic).
CONCLUSIONS


Our results suggest that using 3 closed-suction drains postabdominoplasty with Scarpa fascia preservation has no advantages in total and daily drain output, time to drain removal, or complications when compared with the usual 2 drains approach.",2020,"There were no statistically significant differences between groups in any of the determined variables, namely, main outcomes (total and daily drain output, time to drain removal) or complications (local or systemic).
","['73 abdominoplasties with Scarpa fascia preservation were performed in women (group A, 33 patients; group B, 40 patients']","['3 closed-suction drains', 'Suction drains', 'abdominoplasty with Scarpa fascia preservation with 2 closed-suction drains placed postoperatively (group A) or with 3 closed-suction drains', 'Suction Drain Number']","['main outcomes (total and daily drain output, time to drain removal) or complications (local or systemic', 'total and daily drain output, time to drain removal, or complications', 'seroma rates', 'time to drain removal, total and daily drain output, duration of hospital stay, emergency department visit, readmission to the hospital, secondary surgical procedure, and incidence of postoperative local and systemic complications']","[{'cui': 'C0198542', 'cui_str': 'Abdominoplasty'}, {'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}]","[{'cui': 'C0441139', 'cui_str': 'Suction drain (physical object)'}, {'cui': 'C0198542', 'cui_str': 'Abdominoplasty'}, {'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]","[{'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0411815', 'cui_str': 'Removal of drain (procedure)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",73.0,0.0598204,"There were no statistically significant differences between groups in any of the determined variables, namely, main outcomes (total and daily drain output, time to drain removal) or complications (local or systemic).
","[{'ForeName': 'Andreia', 'Initials': 'A', 'LastName': 'Pisco', 'Affiliation': 'From the Department of Surgery and Physiology, Porto University Medical School.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Rebelo', 'Affiliation': 'Plastic Surgery Department, IPO Porto.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Peres', 'Affiliation': 'Interdisciplinary Centre of Marine and Environmental Research (CIIMAR) and Science Faculty, Porto University.'}, {'ForeName': 'António', 'Initials': 'A', 'LastName': 'Costa-Ferreira', 'Affiliation': 'Department of Plastic, Reconstructive and Aesthetic Surgery, São João Hospital.'}]",Annals of plastic surgery,['10.1097/SAP.0000000000002349']
3500,32143666,Factors associated with loss-to-follow-up of HIV-positive mothers and their infants enrolled in HIV care clinic: A qualitative study.,"BACKGROUND


In Malawi, loss to follow-up (LTFU) of HIV-positive pregnant and postpartum women on Option B+ regimen greatly contributes to sub-optimal retention, estimated to be 74% at 12 months postpartum. This threatens Malawi's efforts to eliminate mother-to-child transmission of HIV. We investigated factors associated with LTFU among Mother-Infant Pairs.
METHODS


We conducted a qualitative study, nested within the ""Promoting Retention Among Infants and Mothers Effectively (PRIME)"" study, a 3-arm cluster randomized trial assessing the effectiveness of strategies for improving retention of mother-infant pairs in HIV care in Salima and Mangochi districts, Malawi. From July to December 2016, we traced and interviewed 19 LTFU women. In addition, we interviewed 30 healthcare workers from health facilities where the LTFU women were receiving care. Recorded interviews were transcribed, translated and then analysed using deductive content analysis.
RESULTS


The following reasons were reported as contributing to LTFU: lack of support from husbands or family members; long distance to health facilities; poverty; community-level stigma; ART side effects; perceived good health after taking ART and adoption of other alternative HIV treatment options.
CONCLUSION


Our study has found multiple factors at personal, family, community and health system levels, which contribute to poor retention of mother-infant pairs in HIV care.",2020,"Option B+ regimen greatly contributes to sub-optimal retention, estimated to be 74% at 12 months postpartum.","['mother-infant pairs in HIV care in Salima and Mangochi districts, Malawi', 'Infants and Mothers', 'From July to December 2016, we traced and interviewed 19 LTFU women', 'HIV-positive pregnant and postpartum women on', '30 healthcare workers from health facilities where the LTFU women were receiving care']",[],[],"[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C0018704', 'cui_str': 'Health Facilities'}]",[],[],19.0,0.0434363,"Option B+ regimen greatly contributes to sub-optimal retention, estimated to be 74% at 12 months postpartum.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mpinganjira', 'Affiliation': 'College of Medicine, University of Malawi, Private Bag 360; Chichiri, Blantyre, 3, Malawi. samlawrent@gmail.com.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Tchereni', 'Affiliation': 'Clinton Health Access Initiative, Boston, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gunda', 'Affiliation': 'Clinton Health Access Initiative, Boston, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Mwapasa', 'Affiliation': 'College of Medicine, University of Malawi, Private Bag 360; Chichiri, Blantyre, 3, Malawi.'}]",BMC public health,['10.1186/s12889-020-8373-x']
3501,31969362,Direct and indirect healthcare costs of lung cancer CT screening in Denmark: a registry study.,"INTRODUCTION


A study based on the Danish Randomised Controlled Lung Cancer Screening Trial (DLCST) calculated the healthcare costs of lung cancer screening by comparing costs in an intervention group with a control group. Participants in both groups, however, experienced significantly increased negative psychosocial consequences after randomisation. Substantial participation bias has also been documented: The DLCST participants reported fewer negative psychosocial aspects and experienced better living conditions compared with the random sample.
OBJECTIVE


To comprehensively analyse the costs of lung cancer CT screening and to determine whether invitations to mass screening alter the utilisation of the healthcare system resulting in indirect costs. Healthcare utilisation and costs are analysed in the primary care sector (general practitioner psychologists, physiotherapists, other specialists, drugs) and the secondary care sector (emergency room contacts, outpatient visits, hospitalisation days, surgical procedures and non-surgical procedures).
DESIGN


To account for bias in the original trial, the costs and utilisation of healthcare by participants in DLCST were compared with a new reference group, selected in the period from randomisation (2004-2006) until 2014.
SETTING


Four Danish national registers.
PARTICIPANTS


DLCST included 4104 current or former heavy smokers, randomly assigned to the CT group or the control group. The new reference group comprised a random sample of 535 current or former heavy smokers in the general Danish population who were never invited to participate in a cancer screening test.
MAIN OUTCOME MEASURES


Total healthcare costs including costs and utilisation of healthcare in both the primary and the secondary care sector.
RESULTS


Compared with the reference group, the participants in both the CT group (offered annual CT screening, lung function test and smoking counselling) and the control group (offered annual lung function test and smoking counselling) had significantly increased total healthcare costs, calculated at 60% and 48% respectively. The increase in costs was caused by increased use of healthcare in both the primary and the secondary sectors.
CONCLUSION


CT screening leads to 60% increased total healthcare costs. Such increase would raise the expected annual healthcare cost per participant from EUR 2348 to EUR 3756. Cost analysis that only includes costs directly related to the CT scan and follow-up procedures most likely underestimates total costs. Our data show that the increased costs are not limited to the secondary sector.
TRIAL REGISTRATION NUMBER


NCT00496977.",2020,"Substantial participation bias has also been documented: The DLCST participants reported fewer negative psychosocial aspects and experienced better living conditions compared with the random sample.
","['DLCST included 4104 current or former heavy smokers', 'Denmark', 'Four Danish national registers', '535 current or former heavy smokers in the general Danish population who were never invited to participate in a cancer screening test', 'primary care sector (general practitioner psychologists, physiotherapists, other specialists, drugs) and the secondary care sector (emergency room contacts, outpatient visits, hospitalisation days, surgical procedures and non-surgical procedures']","['CT screening', 'CT', 'lung cancer CT screening']","['annual CT screening, lung function test and smoking counselling', 'Total healthcare costs including costs and utilisation of healthcare in both the primary and the secondary care sector', 'total healthcare costs', 'costs', 'healthcare costs of lung cancer screening', 'negative psychosocial consequences']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0857118', 'cui_str': 'Heavy smoker'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C2717746', 'cui_str': 'Cancer Screening Tests'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}]","[{'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0281477', 'cui_str': 'Lung cancer screening (procedure)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]",,0.0330338,"Substantial participation bias has also been documented: The DLCST participants reported fewer negative psychosocial aspects and experienced better living conditions compared with the random sample.
","[{'ForeName': 'Manja Dahl', 'Initials': 'MD', 'LastName': 'Jensen', 'Affiliation': 'The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark madj@sund.ku.dk.'}, {'ForeName': 'Volkert', 'Initials': 'V', 'LastName': 'Siersma', 'Affiliation': 'The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jakob Fraes', 'Initials': 'JF', 'LastName': 'Rasmussen', 'Affiliation': 'The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Brodersen', 'Affiliation': 'The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-031768']
3502,31969368,Infant TB Infection Prevention Study (iTIPS): a randomised trial protocol evaluating isoniazid to prevent  M. tuberculosis  infection in HIV-exposed uninfected children.,"INTRODUCTION


HIV-exposed uninfected (HEU) infants in tuberculosis (TB) endemic settings are at high risk of  Mycobacterium tuberculosis  (Mtb) infection and TB disease, even in the absence of known Mtb exposure. Because infancy is a time of rapid progression from primary infection to active TB disease, it is important to define when and how TB preventive interventions exert their effect in order to develop effective prevention strategies in this high-risk population.
METHODS AND ANALYSIS


We designed a non-blinded randomised controlled trial to determine efficacy of isoniazid (INH) to prevent primary Mtb infection among HEU children. Target sample size is 300 (150 infants in each arm). Children are enrolled at 6 weeks of age from maternal and child health clinics in Kenya and are randomised to receive 12 months of daily INH ~10 mg/kg plus pyridoxine or no INH. The primary endpoint is Mtb infection, assessed by interferon-gamma release assay QuantiFERON-TB Gold Plus (QFT-Plus) or tuberculin skin test after 12 months post-enrolment. Secondary outcomes include severe adverse events, expanded Mtb infection definition using additional QFT-Plus supernatant markers and determining correlates of Mtb infection. Exploratory analyses include a combined outcome of TB infection, disease and mortality, and sensitivity analyses excluding infants with baseline TB-specific responses on flow cytometry.
ETHICS AND DISSEMINATION


An external and independent Data and Safety Monitoring Board monitors adverse events. Results will be disseminated through peer-reviewed journals, presentations at local and international conferences to national and global policy-makers, the local community and participants.
TRIAL REGISTRATION NUMBER


NCT02613169; Pre-results.",2020,We designed a non-blinded randomised controlled trial to determine efficacy of isoniazid (INH) to prevent primary Mtb infection among HEU children.,"['300 (150 infants in each arm', 'HIV-exposed uninfected children', 'HEU children', 'Children are enrolled at 6 weeks of age from maternal and child health clinics in Kenya and are randomised to receive 12 months of daily INH ~10']","['pyridoxine or no INH', 'isoniazid (INH', 'isoniazid']","['Mtb infection, assessed by interferon-gamma release assay QuantiFERON-TB Gold Plus (QFT-Plus) or tuberculin skin test', 'TB infection, disease and mortality, and sensitivity analyses excluding infants with baseline TB-specific responses on flow cytometry', 'severe adverse events, expanded Mtb infection definition using additional QFT-Plus supernatant markers and determining correlates of Mtb infection']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0208681', 'cui_str': 'factor XIIa inhibitor'}]","[{'cui': 'C0034272', 'cui_str': 'pyridoxine'}, {'cui': 'C0208681', 'cui_str': 'factor XIIa inhibitor'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}]","[{'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C3178802', 'cui_str': 'Interferon-gamma Release Assays'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0041289', 'cui_str': 'Tuberculin'}, {'cui': 'C0037296', 'cui_str': 'Skin Tests'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0016263', 'cui_str': 'Flow Microfluorimetry'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}]",,0.474935,We designed a non-blinded randomised controlled trial to determine efficacy of isoniazid (INH) to prevent primary Mtb infection among HEU children.,"[{'ForeName': 'Sylvia M', 'Initials': 'SM', 'LastName': 'LaCourse', 'Affiliation': 'Department of Medicine, Division of Allergy and Infectious Diseases, University of Washington, Seattle, Washington, USA sylvial2@uw.edu.'}, {'ForeName': 'Barbra A', 'Initials': 'BA', 'LastName': 'Richardson', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kinuthia', 'Affiliation': 'Research and Programs, Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Warr', 'Affiliation': 'Department of Pediatrics, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Maleche-Obimbo', 'Affiliation': 'Department of Pediatrics and Child Health, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Matemo', 'Affiliation': 'Research and Programs, Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Cranmer', 'Affiliation': 'Department of Pediatrics, Division of Infectious Diseases, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Jaclyn N', 'Initials': 'JN', 'LastName': 'Escudero', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Hawn', 'Affiliation': 'Department of Medicine, Division of Allergy and Infectious Diseases, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Grace C', 'Initials': 'GC', 'LastName': 'John-Stewart', 'Affiliation': 'Department of Medicine, Division of Allergy and Infectious Diseases, University of Washington, Seattle, Washington, USA.'}]",BMJ open,['10.1136/bmjopen-2019-034308']
3503,31969369,"Randomised, double-blind, placebo-controlled clinical trial investigating the effects of inorganic nitrate in hypertension-induced target organ damage: protocol of the NITRATE-TOD study in the UK.","INTRODUCTION


Arterial stiffness and left ventricular (LV) hypertrophy are the key markers of hypertensive target organ damage (TOD) associated with increased cardiovascular morbidity and mortality. We have previously shown that dietary inorganic nitrate supplementation lowers blood pressure (BP) in hypertension, however, whether this approach might also improve markers of hypertensive TOD is unknown. In this study, we will investigate whether daily dietary inorganic nitrate administration reduces LV mass and improves measures of arterial stiffness.
METHODS AND DESIGN


NITRATE-TOD is a double-blind, randomised, single-centre, placebo-controlled phase II trial aiming to enrol 160 patients with suboptimal BP control on one or more antihypertensives. Patients will be randomised to receive 4 months once daily dose of either nitrate-rich beetroot juice or nitrate-deplete beetroot juice (placebo). The primary outcomes are reduction in LV mass and reduction in pulse wave velocity (PWV) and central BP.The study has a power of 95% for detecting a 9 g LV mass change by cardiovascular MRI (~6% change for a mildly hypertrophied heart of 150 g). For PWV, we have a power of >95% for detecting a 0.6 m/s absolute change. For central systolic BP, we have a>90% power to detect a 5.8 mm Hg difference in central systolic BP.Secondary end points include change in ultrasound flow-mediated dilation, change in plasma nitrate and nitrite concentration and change in BP.
ETHICS AND DISSEMINATION


The study was approved by the London-City and East Research Ethics Committee (10/H0703/98). Trial results will be published according to the Consolidated Standards of Reporting Trials statement and will be presented at conferences and reported in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT03088514.",2020,"For PWV, we have a power of >95% for detecting a 0.6 m/s absolute change.",['160 patients with suboptimal BP control on one or more antihypertensives'],"['dietary inorganic nitrate supplementation', 'inorganic nitrate', 'daily dietary inorganic nitrate', 'placebo', 'nitrate-rich beetroot juice or nitrate-deplete beetroot juice (placebo']","['reduction in LV mass and reduction in pulse wave velocity (PWV', 'cardiovascular morbidity and mortality', 'LV mass', 'cardiovascular MRI', 'blood pressure (BP', 'plasma nitrate and nitrite concentration and change in BP', 'central systolic']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}]","[{'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0453112', 'cui_str': 'Beetroot (substance)'}, {'cui': 'C1268568', 'cui_str': 'Juice'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass (finding)'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0427757', 'cui_str': 'Dipstick test of nitrite concentration'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",160.0,0.654798,"For PWV, we have a power of >95% for detecting a 0.6 m/s absolute change.","[{'ForeName': 'Clement Wai Zhen', 'Initials': 'CWZ', 'LastName': 'Lau', 'Affiliation': 'William Harvey Research Institute, Barts & The London, Queen Mary University of London, London, UK.'}, {'ForeName': 'Alexander Jozua Pedro', 'Initials': 'AJP', 'LastName': 'Hamers', 'Affiliation': 'William Harvey Research Institute, Barts & The London, Queen Mary University of London, London, UK.'}, {'ForeName': 'Krishnaraj Sinhji', 'Initials': 'KS', 'LastName': 'Rathod', 'Affiliation': 'William Harvey Research Institute, Barts & The London, Queen Mary University of London, London, UK.'}, {'ForeName': 'Asad', 'Initials': 'A', 'LastName': 'Shabbir', 'Affiliation': 'William Harvey Research Institute, Barts & The London, Queen Mary University of London, London, UK.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Cooper', 'Affiliation': 'William Harvey Research Institute, Barts & The London, Queen Mary University of London, London, UK.'}, {'ForeName': 'Christopher Peter', 'Initials': 'CP', 'LastName': 'Primus', 'Affiliation': 'William Harvey Research Institute, Barts & The London, Queen Mary University of London, London, UK.'}, {'ForeName': 'Ceri', 'Initials': 'C', 'LastName': 'Davies', 'Affiliation': 'William Harvey Research Institute, Barts & The London, Queen Mary University of London, London, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Mathur', 'Affiliation': 'William Harvey Research Institute, Barts & The London, Queen Mary University of London, London, UK.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Moon', 'Affiliation': 'Department of Cardiology, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Kapil', 'Affiliation': 'William Harvey Research Institute, Barts & The London, Queen Mary University of London, London, UK.'}, {'ForeName': 'Amrita', 'Initials': 'A', 'LastName': 'Ahluwalia', 'Affiliation': 'William Harvey Research Institute, Barts & The London, Queen Mary University of London, London, UK a.ahluwalia@qmul.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2019-034399']
3504,31988226,Referral to Slimming World in UK Stop Smoking Services (SWISSS) versus stop smoking support alone on body weight in quitters: results of a randomised controlled trial.,"INTRODUCTION


Most people who stop smoking gain weight. Dietary modification may seem an obvious solution, but food restriction may increase cigarette craving and smoking relapse.
TRIAL DESIGN


An unblinded parallel randomised controlled trial.
METHODS


Participants were adult smokers with a body mass index greater or equal to 23 kg/m 2 . Setting was National Health Service commissioned Stop Smoking Services, interventions were referral to a commercial weight management programme, plus stop smoking support (treatment group), compared with stop smoking support alone (control group). Objective was to compare weight change between interventions in smoking abstainers and not abstinent rates in all. Primary outcome was change in weight (kg) at 12 weeks. Randomisation sequence was computer generated and concealed until allocation.
RESULTS


Seventy-six participants were recruited, 37 were randomised to the treatment group and 39 to the control group. Change in weight was analysed in long-term abstainers (13 treatment, 14 control) only because the aim was to prevent weight gain associated with smoking cessation. Abstinence was analysed on an intention-to-treat basis (37 treatment, 39 control). At 12 weeks weight gain was less in the treatment than the control group with an adjusted mean difference of -2.3 kg 95% CI (-4.4 to -0.1). Craving scores were lower (Mood and Physical Symptoms Scale craving domain -1.6 (-2.7 to -0.5)) and quit rates were higher in the treatment than the control group (32% vs 21%), although the trial was not powered to superiority in cravings and quit rates. No adverse events or side effects were reported.
CONCLUSION


In people who are obese and want to quit smoking, these data provide modest encouragement that providing weight management at the time of quitting may be helpful. Those who are not obese, but who are informed about potential weight gain during their quit attempt, were uninterested in a weight management programme.
TRIAL REGISTRATION NUMBER


ISRCTN65705512.",2020,Craving scores were lower (Mood and Physical Symptoms Scale craving domain,"['Participants were adult smokers with a body mass index greater or equal to 23\u2009kg/m 2 ', 'people who stop smoking gain weight', 'Seventy-six participants were recruited, 37 were randomised to the treatment group and 39 to the control group', 'on body weight in quitters']","['stop smoking support alone (control group', 'Referral to Slimming World in UK Stop Smoking Services (SWISSS) versus stop smoking support alone']","['cigarette craving and smoking relapse', 'change in weight (kg', 'adverse events or side effects', 'Change in weight', 'lower (Mood and Physical Symptoms Scale craving domain', 'Craving scores', 'quit rates', 'weight gain', 'cravings and quit rates', 'weight change']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4319622', 'cui_str': 'Seventy-six'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]","[{'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0425310', 'cui_str': 'Stopped smoking (finding)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0222045'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}]",76.0,0.127858,Craving scores were lower (Mood and Physical Symptoms Scale craving domain,"[{'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Lycett', 'Affiliation': 'Faculty of Health and Life Sciences, Coventry University, Coventry, West Midlands, UK deborah.lycett@coventry.ac.uk.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Farmer', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Lewis', 'Affiliation': 'Population Health Sciences Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Munafò', 'Affiliation': 'School of Experimental Psychology, University of Bristol, Bristol, UK.'}]",BMJ open,['10.1136/bmjopen-2019-032271']
3505,31988233,"Pharmacodynamics effects of CDK4/6 inhibitor LEE011 (ribociclib) in high-risk, localised prostate cancer: a study protocol for a randomised controlled phase II trial (LEEP study: LEE011 in high-risk, localised Prostate cancer).","INTRODUCTION


Despite the development of new therapies for advanced prostate cancer, it remains the most common cause of cancer and the second leading cause of cancer death in men. It is critical to develop novel agents for the treatment of prostate cancer, particularly those that target aspects of androgen receptor (AR) signalling or prostate biology other than inhibition of androgen synthesis or AR binding. Neoadjuvant pharmacodynamic studies allow for a rational approach to the decisions regarding which targeted therapies should progress to phase II/III trials. CDK4/6 inhibitors have evidence of efficacy in breast cancer, and have been shown to have activity in preclinical models of hormone sensitive and castrate resistant prostate cancer. The LEEP trial aims to assess the pharmacodynamic effects of LEE011 (ribociclib), an orally bioavailable and highly selective CDK4/6 inhibitor, in men undergoing radical prostatectomy for high-risk, localised prostate cancer.
METHODS AND ANALYSIS


The multicentre randomised, controlled 4:1 two-arm, phase II, open label pharmacodynamic study will recruit 47 men with high risk, localised prostate cancer who are planned to undergo radical prostatectomy. Participants who are randomised to receive the study treatment will be treated with LEE011 400 mg daily for 21 days for one cycle. The primary endpoint is the frequency of a 50% reduction in Ki-67 proliferation index from the pretreatment prostate biopsy compared to that present in prostate cancer tissue from radical prostatectomy. Secondary and tertiary endpoints include pharmacodynamic assessment of CDK4/6 cell cycle progression via E2F levels, apoptotic cell death by cleaved caspase-3, changes in serum and tumour levels of Prostate Specific Antigen (PSA), pathological regression, safety via incidence of adverse events and exploratory biomarker analysis.
ETHICS AND DISSEMINATION


The protocol was approved by a central ethics review committee (St Vincent's Hospital HREC) for all participating sites (HREC/17/SVH/294). Results will be disseminated in peer-reviewed journals and at scientific conferences.
DRUG SUPPLY


Novartis.
PROTOCOL VERSION


2.0, 30 May 2019 TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12618000354280).",2020,Neoadjuvant pharmacodynamic studies allow for a rational approach to the decisions regarding which targeted therapies should progress to phase II/III trials.,"['2.0, 30', 'advanced prostate cancer', '47 men with high risk, localised prostate cancer who are planned to undergo radical prostatectomy', 'high-risk, localised prostate cancer', 'men undergoing radical prostatectomy for high-risk, localised prostate cancer']","['CDK4/6 inhibitors', 'LEE011 (ribociclib), an orally bioavailable and highly selective CDK4/6 inhibitor', 'CDK4/6 inhibitor LEE011 (ribociclib', 'LEE011']","['pharmacodynamic assessment of CDK4/6\u2009cell cycle progression via E2F levels, apoptotic cell death by cleaved caspase-3, changes in serum and tumour levels of Prostate Specific Antigen (PSA), pathological regression, safety via incidence of adverse events and exploratory biomarker analysis', 'frequency of a 50% reduction in Ki-67 proliferation index']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2987342', 'cui_str': 'LEE011'}, {'cui': 'C0935763', 'cui_str': 'Bioavailable'}, {'cui': 'C4045494', 'cui_str': 'ribociclib'}]","[{'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0007586', 'cui_str': 'Cell Division Cycle'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0007587', 'cui_str': 'Cell Death'}, {'cui': 'C0205242', 'cui_str': 'Cleaved (qualifier value)'}, {'cui': 'C0291573', 'cui_str': 'CASP3'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0334094', 'cui_str': 'Proliferation (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",47.0,0.0928258,Neoadjuvant pharmacodynamic studies allow for a rational approach to the decisions regarding which targeted therapies should progress to phase II/III trials.,"[{'ForeName': 'Tahlia', 'Initials': 'T', 'LastName': 'Scheinberg', 'Affiliation': ""Medical Oncology, Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kench', 'Affiliation': 'School of Medicine, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Stockler', 'Affiliation': ""Medical Oncology, Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia.""}, {'ForeName': 'Kate L', 'Initials': 'KL', 'LastName': 'Mahon', 'Affiliation': ""Medical Oncology, Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia.""}, {'ForeName': 'Lucille', 'Initials': 'L', 'LastName': 'Sebastian', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Stricker', 'Affiliation': 'Cancer Research, Garvan Institute of Medical Research, Darlinghurst, New South Wales, Australia.'}, {'ForeName': 'Anthony M', 'Initials': 'AM', 'LastName': 'Joshua', 'Affiliation': 'Cancer Research, Garvan Institute of Medical Research, Darlinghurst, New South Wales, Australia.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Woo', 'Affiliation': 'School of Medicine, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Ruban', 'Initials': 'R', 'LastName': 'Thanigasalam', 'Affiliation': 'School of Medicine, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Nariman', 'Initials': 'N', 'LastName': 'Ahmadi', 'Affiliation': ""Urology, Chris O'Brien Lifehouse, Camperdown, NSW, Australia.""}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Centenera', 'Affiliation': 'Prostate Cancer Research Group, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Butler', 'Affiliation': 'Prostate Cancer Research Group, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.'}, {'ForeName': 'Lisa G', 'Initials': 'LG', 'LastName': 'Horvath', 'Affiliation': ""Medical Oncology, Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia lisa.horvath@lh.org.au.""}]",BMJ open,['10.1136/bmjopen-2019-033667']
3506,31992604,Is telehealthcare for heart failure patients cost-effective? An economic evaluation alongside the Danish TeleCare North heart failure trial.,"OBJECTIVE


This study aimed to assess the cost-effectiveness of telehealthcare in heart failure patients as add-on to usual care.
DESIGN


A cost-utility analysis was conducted from a public payer perspective alongside the randomised controlled TeleCare North trial.
SETTING


The North Denmark Region, Denmark.
PARTICIPANTS


The study included 274 heart failure patients with self-reported New York Heart Association class II-IV.
INTERVENTIONS


Patients in the intervention group were provided with a Telekit consisting of a tablet, a digital blood pressure monitor, and a scale and were instructed to perform measurements one to two times a week. The responsibility of the education, instructions and monitoring of the heart failure (HF) patients was placed on municipality nurses trained in HF and telemonitoring. Both groups received usual care.
OUTCOME MEASURES


Cost-effectiveness was reported as incremental net monetary benefit (NMB). A micro-costing approach was applied to evaluate the derived savings in the first year in the public health sector. Quality-adjusted life-years (QALY) gained were estimated using the EuroQol 5-Dimensions 5-Levels questionnaire at baseline and at a 1-year follow-up.
RESULTS


Data for 274 patients were included in the main analysis. The telehealthcare solution provided a positive incremental NMB of £5164. The 1-year adjusted QALY difference between the telehealthcare solution and the usual care group was 0.0034 (95% CI: -0.0711 to 0.0780). The adjusted difference in costs was -£5096 (95% CI: -8736 to -1456) corresponding to a reduction in total healthcare costs by 35%. All sensitivity analyses showed the main results were robust.
CONCLUSIONS


The TeleCare North solution for monitoring HF was highly cost-effective. There were significant cost savings on hospitalisations, primary care contacts and total costs.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov: NCT02860013.",2020,The 1-year adjusted QALY difference between the telehealthcare solution and the usual care group was 0.0034 (95% CI: -0.0711 to 0.0780).,"['heart failure patients', '274 heart failure patients with self-reported New York Heart Association class II-IV', 'The North Denmark Region, Denmark', '274 patients were included in the main analysis']","['telehealthcare', 'usual care']","['1-year adjusted QALY difference', 'cost savings on hospitalisations, primary care contacts and total costs', 'total healthcare costs', 'incremental net monetary benefit (NMB', 'cost-effectiveness', 'Quality-adjusted life-years (QALY', 'Cost-effectiveness']","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",[],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0085550', 'cui_str': 'Saving, Cost'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",274.0,0.102219,The 1-year adjusted QALY difference between the telehealthcare solution and the usual care group was 0.0034 (95% CI: -0.0711 to 0.0780).,"[{'ForeName': 'Anne Sig', 'Initials': 'AS', 'LastName': 'Vestergaard', 'Affiliation': 'Danish Center for Healthcare Improvements, Department of Business and Management, Aalborg University, Aalborg Oest, Denmark.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Hansen', 'Affiliation': 'Danish Center for Healthcare Improvements, Department of Business and Management, Aalborg University, Aalborg Oest, Denmark.'}, {'ForeName': 'Sabrina Storgaard', 'Initials': 'SS', 'LastName': 'Sørensen', 'Affiliation': 'Danish Center for Healthcare Improvements, Department of Business and Management, Aalborg University, Aalborg Oest, Denmark.'}, {'ForeName': 'Morten Berg', 'Initials': 'MB', 'LastName': 'Jensen', 'Affiliation': 'Aarhus Business School, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Lars Holger', 'Initials': 'LH', 'LastName': 'Ehlers', 'Affiliation': 'Danish Center for Healthcare Improvements, Department of Business and Management, Aalborg University, Aalborg Oest, Denmark lehlers@dcm.aau.dk.'}]",BMJ open,['10.1136/bmjopen-2019-031670']
3507,32001493,PERCEPT myeloma: a protocol for a pilot randomised controlled trial of exercise prehabilitation before and during autologous stem cell transplantation in patients with multiple myeloma.,"INTRODUCTION


Myeloma, a blood cancer originating from plasma cells, is the most common indication for autologous stem cell transplantation (SCT). Patients with myeloma undergoing autologous SCT (ASCT) experience treatment-related morbidity and reduction in function and well-being for many months post-treatment. Interventions targeting physical functioning delivered prior to and during SCT have shown promising results in mixed haematological populations and may offer a non-pharmacological solution to physically optimising and preparing patients for SCT. The aim of this study is to investigate the feasibility of a physiotherapist-led exercise intervention as an integral part of the myeloma ASCT pathway at a UK tertiary centre.
METHODS AND ANALYSIS


PERCEPT is a single-site, pilot randomised controlled trial of an exercise intervention embedded within the myeloma ASCT pathway, compared with usual care. The primary study end points will be feasibility measures of study and intervention delivery including recruitment rates, acceptability of intervention, study completion rate and any adverse events. Secondary end points will evaluate differences between the exercise intervention group and the usual care control group in cancer-related fatigue, quality of life, functional capacity (6 min walk test; handheld dynamometry; a timed sit-to-stand test) and objective and self-reported physical activity. Outcomes will be assessed at four time points, approximately 6-8 weeks prior to SCT, on/around day of SCT, on discharge from SCT hospital admission and 12 weeks post-discharge. The exercise intervention comprises of partly supervised physiotherapist-led aerobic and resistance exercise including behaviour change techniques to promote change in exercise behaviour. The primary outcomes from the trial will be summarised as percentages or mean values with 95% CIs. Group differences for secondary outcomes at each time point will be analysed using appropriate statistical models.
ETHICS AND DISSEMINATION


This study has NHS REC approval (Camden and Kings Cross, 19/LO/0204). Results will be disseminated through publication and presentations at haematology and rehabilitation-related meetings.
TRIAL REGISTRATION NUMBER


ISRCTN15875290.",2020,"Secondary end points will evaluate differences between the exercise intervention group and the usual care control group in cancer-related fatigue, quality of life, functional capacity (6 min walk test; handheld dynamometry; a timed sit-to-stand test) and objective and self-reported physical activity.","['Patients with myeloma undergoing', 'patients with multiple myeloma']","['exercise intervention', 'autologous stem cell transplantation', 'physiotherapist-led exercise intervention', 'exercise intervention comprises of partly supervised physiotherapist-led aerobic and resistance exercise including behaviour change techniques', 'autologous SCT (ASCT']","['feasibility measures of study and intervention delivery including recruitment rates, acceptability of intervention, study completion rate and any adverse events', 'cancer-related fatigue, quality of life, functional capacity (6\u2009min walk test; handheld dynamometry; a timed sit-to-stand test) and objective and self-reported physical activity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4274302', 'cui_str': 'Fatigue associated with malignant neoplastic disease'}, {'cui': 'C0034380'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.162006,"Secondary end points will evaluate differences between the exercise intervention group and the usual care control group in cancer-related fatigue, quality of life, functional capacity (6 min walk test; handheld dynamometry; a timed sit-to-stand test) and objective and self-reported physical activity.","[{'ForeName': 'Orla', 'Initials': 'O', 'LastName': 'McCourt', 'Affiliation': 'Therapies & Rehabilitation, University College London Hospitals NHS Foundation Trust, London, UK o.mccourt@nhs.net.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Fisher', 'Affiliation': 'Research Department of Behavoural Science and Health, University College London, London, UK.'}, {'ForeName': 'Gita', 'Initials': 'G', 'LastName': 'Ramdharry', 'Affiliation': 'Queen Square Centre for Neuromuscular Diseases, University College London, London, UK.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Roberts', 'Affiliation': 'Research Department of Behavoural Science and Health, University College London, London, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Land', 'Affiliation': 'Research Department of Behavoural Science and Health, University College London, London, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Rabin', 'Affiliation': 'Department of Haematology, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Kwee', 'Initials': 'K', 'LastName': 'Yong', 'Affiliation': 'Research Department of Haematology, Cancer Institute, University College London, London, UK.'}]",BMJ open,['10.1136/bmjopen-2019-033176']
3508,31363946,Examining the Differential Effects of a Universal SEL Curriculum on Student Functioning Through the Dual Continua Model of Mental Health.,"Social-emotional learning (SEL) curricula, such as Second Step, are increasingly being adopted and implemented as universal supports in schools in order to prevent social-emotional and behavioral problems and promote wellbeing and success. Notwithstanding the empirical support for SEL as a universal prevention strategy, a closer look at the literature indicates that students display differential responses to SEL based on their behavioral functioning at baseline; those students with the highest need benefit the most from SEL. The primary purpose of this study was to evaluate whether a widely-adopted SEL program produces significant effects for different theoretically-constructed groups of students who are representative of the full spectrum of students in a school. Using data from a large-scale randomized controlled trial evaluating Second Step, analyses examined the extent to which group membership according to the dual continua model of mental health differentially changed based on whether the student was in the intervention or control condition. Overall, results evidenced significant effects favoring the intervention condition across groups in line with our general hypotheses, although both conditions experienced transitions in membership. As expected, those in the intervention condition experienced greater transition between groups, which was indicative of either treatment or prevention effects. Implications, limitations, and future directions of the findings for SEL programming in schools are discussed.",2019,"As expected, those in the intervention condition experienced greater transition between groups, which was indicative of either treatment or prevention effects.","['Student Functioning Through the Dual Continua Model of Mental Health', 'students who are representative of the full spectrum of students in a school']","['Universal SEL Curriculum', 'Social-emotional learning (SEL) curricula']",[],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1532530', 'cui_str': 'Full spectrum'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0582589', 'cui_str': 'Emotional learning (observable entity)'}, {'cui': 'C0010478', 'cui_str': 'Curriculum'}]",[],,0.0241842,"As expected, those in the intervention condition experienced greater transition between groups, which was indicative of either treatment or prevention effects.","[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Thayer', 'Affiliation': 'Department of Educational Psychology, University of Minnesota, Twin Cities, 56 East River Road, Minneapolis, MN, 55455, USA. thaye053@umn.edu.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Campa', 'Affiliation': 'University of Washington College of Education, 2012 Skagit Lane, Miller Hall, Box 353600, Seattle, WA, 98195-3600, USA.'}, {'ForeName': 'Mollie R', 'Initials': 'MR', 'LastName': 'Weeks', 'Affiliation': 'Department of Educational Psychology, University of Minnesota, Twin Cities, 56 East River Road, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Buntain-Ricklefs', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, 2815 Eastlake Ave E #200, Seattle, WA, 98102, USA.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Low', 'Affiliation': 'T Denny Sanford School of Social and Family Dynamics, Arizona State University, Tempe, USA.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Larson', 'Affiliation': 'Department of Educational Psychology, University of Minnesota, Twin Cities, 56 East River Road, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Clayton R', 'Initials': 'CR', 'LastName': 'Cook', 'Affiliation': 'Department of Educational Psychology, University of Minnesota, Twin Cities, 56 East River Road, Minneapolis, MN, 55455, USA.'}]",The journal of primary prevention,['10.1007/s10935-019-00557-0']
3509,31932387,Bluebelle pilot randomised controlled trial of three wound dressing strategies to reduce surgical site infection in primary surgical wounds.,"OBJECTIVE


Surgical site infection (SSI) affects up to 25% of primary surgical wounds. Dressing strategies may influence SSI risk. The Bluebelle study assessed the feasibility of a multicentre randomised controlled trial (RCT) to evaluate the effectiveness and cost-effectiveness of different dressing strategies to reduce SSI in primary surgical wounds.
DESIGN


A pilot, factorial RCT.
SETTING


Five UK hospitals.
PARTICIPANTS


Adults undergoing abdominal surgery with a primary surgical wound.
INTERVENTIONS


Participants were randomised to 'simple dressing', 'glue-as-a-dressing' or 'no dressing', and to the time at which the treatment allocation was disclosed to the surgeon (disclosure time, before or after wound closure).
PRIMARY AND SECONDARY OUTCOME MEASURES


Feasibility outcomes focused on recruitment, adherence to randomised allocations, reference assessment of SSI and response rates to participant-completed and observer-completed questionnaires to assess SSI (proposed primary outcome for main trial), wound experience and symptoms, and quality of life (EQ-5D-5L).
RESULTS


Between March and November 2016, 1115 patients were screened; 699 (73.4%) were eligible and approached, 415 (59.4%) consented and 394 (35.3%) were randomised (simple dressing=133, glue=129 and 'no dressing'=132). Non-adherence to dressing allocation was 2% (3/133), 6% (8/129) and 15% (20/132), respectively. Adherence to disclosure time was 99% and 86% before and after wound closure, respectively. The overall rate of SSI (reference assessment) was 18.1% (51/281). Response rates to the Wound Healing Questionnaire and other questionnaires ranged from >90% at 4 days to 68% at 4-8 weeks.
CONCLUSIONS


A definitive RCT of dressing strategies including 'no dressing' is feasible. Further work is needed to optimise questionnaire response rates.
TRIAL REGISTRATION NUMBER


49328913; Pre-results.",2020,"Response rates to the Wound Healing Questionnaire and other questionnaires ranged from >90% at 4 days to 68% at 4-8 weeks.
","[' 1115 patients were screened; 699 (73.4%) were eligible and approached, 415 (59.4%) consented and 394 (35.3', 'primary surgical wounds', 'Five UK hospitals', 'Adults undergoing abdominal surgery with a primary surgical wound', 'Between March and November 2016']","[""simple dressing', 'glue-as-a-dressing' or 'no dressing""]","['wound experience and symptoms, and quality of life (EQ-5D-5L', 'overall rate of SSI (reference assessment', 'adherence to dressing allocation', 'Adherence to disclosure time', 'effectiveness and cost-effectiveness', 'recruitment, adherence to randomised allocations, reference assessment of SSI and response rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C4517772', 'cui_str': 'Four hundred and fifteen'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0332803', 'cui_str': 'Surgical Incision'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C0017780', 'cui_str': 'Glues'}]","[{'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C4321376', 'cui_str': 'Dressing'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}]",1115.0,0.193773,"Response rates to the Wound Healing Questionnaire and other questionnaires ranged from >90% at 4 days to 68% at 4-8 weeks.
","[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Blazeby', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK j.m.blazeby@bristol.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-030615']
3510,32005781,Non-inferiority and cost-effectiveness trial of isolated biceps tenotomy versus tenotomy with rotator cuff repair in patients with stage 2-3 Goutallier fatty degenerative cuff lesions (TenCuRe study): protocol of a multicentre randomised controlled trial.,"INTRODUCTION


For patients who are diagnosed with lesions of the rotator cuff that present advanced levels of fatty degeneration, arthroscopic repair of the rotator cuff remains controversial. This controversy can be attributed to the frequently reported high failure rate of the tendon fixation and the fact that it remains unclear why repair for these tears results in significant clinical improvement independent of the occurrence of such a re-tear. Recent publications have reported comparable clinical improvements when merely a tenotomy of the long head of the biceps tendon was performed and the rotator cuff tear was left untreated. These observations raise questions on the value of performing the more extensive cuff repairs in degenerative cuff tears. Even more, rehabilitation after an isolated tenotomy is much less cumbersome as compared with rehabilitation after rotator cuff repair and, therefore, might result in improved patient satisfaction. The goal of this trial is to study function and quality-of-life of patients undergoing arthroscopic biceps tenotomy with or without an additional cuff repair and to include an economic evaluation.
METHODS AND ANALYSIS


This multicentre randomised controlled non-inferiority trial, including an economic evaluation, is designed to compare the short-term and long-term outcome of patients who underwent an arthroscopic tenotomy of the long head of the biceps tendon with or without a cuff repair. We will include 172 patients with stage 2-3 Goutallier fatty infiltration cuff tears and with clinical symptoms of biceps pathology. Primary outcome is the rotator cuff specific quality-of-life (Western Ontario Rotator Cuff index) on the short term (6 months postoperatively). Secondary outcomes are quality-of-life 1, 2 and 5 year postoperatively and function (Constant-Murley score, glenohumeral range of motion), recovery status, pain (visual analogue scale), economic evaluation, satisfaction of treatment on the short-term and long-term and re-tear rate at 6 months determined with an ultrasound.
ETHICS AND DISSEMINATION


This trial has been approved by the Medical Research Ethics Committees United (MEC-U), Nieuwegein, the Netherlands (NL54313.100.15) and will be performed in accordance with the Declaration of Helsinki with the Medical Research Involving Human Subjects Act (WMO). The results of this study will be reported in peer-reviewed journals and at (inter)national conferences. Furthermore, we will share our findings with the appropriate guideline committees.
TRIAL REGISTRATION NUMBER


The Dutch Trial Registry (NL4010).",2020,Primary outcome is the rotator cuff specific quality-of-life (Western Ontario Rotator Cuff index) on the short term (6 months postoperatively).,"['patients who underwent an arthroscopic tenotomy of the long head of the biceps tendon with or without a cuff repair', 'patients with stage 2-3 Goutallier fatty degenerative cuff lesions (TenCuRe study', '172 patients with stage 2-3 Goutallier fatty infiltration cuff tears and with clinical symptoms of biceps pathology', 'patients undergoing']","['arthroscopic biceps tenotomy with or without an additional cuff repair', 'isolated biceps tenotomy versus tenotomy with rotator cuff repair']","['quality-of-life 1, 2 and 5\u2009year postoperatively and function (Constant-Murley score, glenohumeral range of motion), recovery status, pain (visual analogue scale), economic evaluation, satisfaction of treatment on the short-term and long-term and re-tear rate at 6 months determined with an ultrasound', 'rotator cuff specific quality-of-life (Western Ontario Rotator Cuff index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0856438', 'cui_str': 'Tenotomy (psoas)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C0333575', 'cui_str': 'Fatty infiltration (morphologic abnormality)'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}]","[{'cui': 'C0856438', 'cui_str': 'Tenotomy (psoas)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder (procedure)'}]","[{'cui': 'C0034380'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0150099', 'cui_str': 'Economic Evaluation'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0085515', 'cui_str': 'Rotator Cuff'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",172.0,0.104764,Primary outcome is the rotator cuff specific quality-of-life (Western Ontario Rotator Cuff index) on the short term (6 months postoperatively).,"[{'ForeName': 'Freek', 'Initials': 'F', 'LastName': 'Hollman', 'Affiliation': 'Orthopedic Surgery, St. Antonius Ziekenhuis, Nieuwegein, The Netherlands.'}, {'ForeName': 'Nienke', 'Initials': 'N', 'LastName': 'Wolterbeek', 'Affiliation': 'Orthopedic Surgery, St. Antonius Ziekenhuis, Nieuwegein, The Netherlands n.wolterbeek@antoniusziekenhuis.nl.'}, {'ForeName': 'Gie', 'Initials': 'G', 'LastName': 'Auw Yang', 'Affiliation': 'Orthopedic Surgery, St. Antonius Ziekenhuis, Nieuwegein, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2019-032936']
3511,30878017,"Association of Patisiran, an RNA Interference Therapeutic, With Regional Left Ventricular Myocardial Strain in Hereditary Transthyretin Amyloidosis: The APOLLO Study.","Importance


Patients with cardiac amyloidosis demonstrate reduced myocardial strain with associated sparing of the cardiac apex. In the APOLLO randomized clinical trial, patisiran, an RNA interference therapeutic that inhibits transthyretin synthesis, improved left ventricular (LV) global longitudinal strain (LV GLS) compared with placebo in patients with hereditary transthyretin-mediated (hATTR) amyloidosis with polyneuropathy and evidence of cardiac involvement.
Objective


To evaluate the treatment association of patisiran with regional LV myocardial strain in cardiac manifestation in hATTR amyloidosis.
Design, Setting, and Participants


This exploratory analysis of APOLLO, a randomized, double-blind, placebo-controlled, phase 3, multicenter international clinical trial that was conducted from December 2013 to January 2016, included patients with hATTR amyloidosis with polyneuropathy who were randomized 2:1 to receive patisiran or placebo. The prespecified cardiac subpopulation (126 of 225 [56%]) comprised patients with a baseline LV wall thickness of 13 mm or more and no history of hypertension or aortic valve disease. This post hoc data analysis was performed between September 2018 and January 2019.
Intervention


Placebo or patisiran, 0.3 mg/kg, via intravenous infusion once every 3 weeks for 18 months.
Main Outcomes and Measures


The association of patisiran with LV regional longitudinal strain at 18 months.
Results


Of the 126 patients included in the prespecified cardiac subpopulation, 36 patients (28.6%) received placebo (median [interquartile range] age, 62 [57-72] years) and 90 patients (71.4%) received patisiran (median [interquartile range] age, 60 [54-66] years); 98 (77.8%) were men, 28 (22.2%) were from North America, and 43 (34.1%) were from Western Europe. At baseline, LV GLS was impaired and regional longitudinal strains were lowest in the basal segments with apical sparing. There were no differences in regional longitudinal strains between the treatment groups at baseline. Patisiran improved the absolute GLS (least-squares mean [SE] difference, 1.4% [0.6%]; 95% CI, 0.3%-2.5%; P = .02) compared with placebo at 18 months, with the greatest differential increase observed in the basal region (overall least-squares mean [SE] difference, 2.1% [0.8%]; 95% CI, 0.6%-3.6%; P = .006) and no significant differences in the mid and apical regions among groups.
Conclusions and Relevance


Patisiran prevented the deterioration of LV GLS over 18 months, driven primarily by attenuating disease progression in the basal region, suggesting that basal longitudinal strain may be a more sensitive marker of treatment associations with the cardiac manifestation in hATTR amyloidosis and that basal region may be influenced by disease-modifying therapies more than other ventricular regions.
Trial Registration


ClinicalTrials.gov identifier: NCT01960348.",2019,There were no differences in regional longitudinal strains between the treatment groups at baseline.,"['Importance\n\n\nPatients with cardiac amyloidosis', 'Hereditary Transthyretin Amyloidosis', 'December 2013 to January 2016, included patients with hATTR amyloidosis with polyneuropathy', '126 patients included in the prespecified cardiac subpopulation, 36 patients (28.6%) received', 'median [interquartile range] age, 62 [57-72] years) and 90 patients (71.4%) received patisiran (median [interquartile range] age, 60 [54-66] years); 98 (77.8%) were men, 28 (22.2%) were from North America, and 43 (34.1%) were from Western Europe', 'patients with hereditary transthyretin-mediated (hATTR) amyloidosis with polyneuropathy and evidence of cardiac involvement']","['patisiran or placebo', 'placebo', 'Placebo', 'patisiran with regional LV myocardial strain']","['hypertension or aortic valve disease', 'association of patisiran with LV regional longitudinal strain at 18 months', 'regional longitudinal strains', 'basal region', 'absolute GLS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0268407', 'cui_str': 'Senile cardiac amyloidosis (disorder)'}, {'cui': 'C0439660', 'cui_str': 'Hereditary (qualifier value)'}, {'cui': 'C2751492', 'cui_str': 'Familial Transthyretin Cardiac Amyloidosis'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0002726', 'cui_str': 'Amyloidosis'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C4517679', 'cui_str': '28.6'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3896714', 'cui_str': 'patisiran'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0043129', 'cui_str': 'Western Europe'}, {'cui': 'C0032923', 'cui_str': 'Transthyretin'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}]","[{'cui': 'C3896714', 'cui_str': 'patisiran'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C1868749', 'cui_str': 'Myocardial strain'}]","[{'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1260873', 'cui_str': 'Aortic valve disorder'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C3896714', 'cui_str': 'patisiran'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}]",,0.391681,There were no differences in regional longitudinal strains between the treatment groups at baseline.,"[{'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Minamisawa', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Claggett', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Adams', 'Affiliation': 'National Reference Center for FAP/Assitance Publique-Hôpitaux de Paris/ Inserm U 1195/ CHU Bicêtre, Le Kremlin- Bicêtre, France.'}, {'ForeName': 'Arnt V', 'Initials': 'AV', 'LastName': 'Kristen', 'Affiliation': 'Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Giampaolo', 'Initials': 'G', 'LastName': 'Merlini', 'Affiliation': 'Scientific Institute for Research and Healthcare, Policlinico San Matteo Hospital, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Michel S', 'Initials': 'MS', 'LastName': 'Slama', 'Affiliation': 'National Reference Center for FAP/Assitance Publique-Hôpitaux de Paris/ Inserm U 1195/ CHU Bicêtre, Le Kremlin- Bicêtre, France.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Dispenzieri', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Amil M', 'Initials': 'AM', 'LastName': 'Shah', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Rodney H', 'Initials': 'RH', 'LastName': 'Falk', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Karsten', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, Massachusetts.'}, {'ForeName': 'Marianne T', 'Initials': 'MT', 'LastName': 'Sweetser', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, Massachusetts.'}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, Massachusetts.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Riese', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, Massachusetts.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Vest', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, Massachusetts.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}]",JAMA cardiology,['10.1001/jamacardio.2019.0849']
3512,31974091,Circular pOlyethylene drape in preVEntion of suRgical site infection (COVER trial): study protocol for a randomised controlled trial.,"INTRODUCTION


Surgical site infection (SSI) after abdominal surgery remains a significant cause of morbidity and is associated with an increased socioeconomic burden and a reduced quality of life. Circular wound protectors have been expected to reduce the risk of SSI, but previous studies reported conflicting results on their protective effects. The purpose of this study was to evaluate the efficacy of circular wound protectors in reducing SSI in open abdominal surgery.
METHODS AND ANALYSIS


The circular pOlyethylen drape in preVEntion of suRgical site infection (COVER) trial investigates whether the application of a dual-ring circular plastic wound protector reduces the rate of SSI in patients undergoing elective or emergent open abdominal surgery related to the gastrointestinal tract, regardless of the type of wound classified by the Centers for Disease Control. The COVER trial is a multicentre, randomised controlled clinical trial with two parallel arms-one using a dual-ring wound protector with circular polyethylene drape and the other using conventional surgical dressing gauze. The primary outcome will measure the rate of SSI within 30 days after surgery in two groups. Statistical analysis of the primary end point will be based on the intention-to-treat population. The sample size was determined to achieve a study power of 80% with 95% two-sided confidence limits. Considering a dropout rate of up to 5%, a total of 458 patients, 229 patients in each group, will be enrolled in this study.
ETHICS AND DISSEMINATION


The trial protocol and informed consent document have been reviewed and approved by the institutional review board at each participating centre. Written informed consent will be obtained from each study participant. The clinical outcomes of this trial will be submitted to an international peer-reviewed journal and presented at international conferences.
TRIAL REGISTRATION NUMBER


NCT03170843.",2020,"The purpose of this study was to evaluate the efficacy of circular wound protectors in reducing SSI in open abdominal surgery.
","['patients undergoing elective or emergent open abdominal surgery related to the gastrointestinal tract, regardless of the type of wound classified by the Centers for Disease Control', 'suRgical site infection (COVER trial']","['Circular pOlyethylene drape', 'circular wound protectors', 'dual-ring wound protector with circular polyethylene drape and the other using conventional surgical dressing gauze']",['rate of SSI'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal Tract'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0007670', 'cui_str': 'CDC'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}]","[{'cui': 'C1282913', 'cui_str': 'Circular (qualifier value)'}, {'cui': 'C0137914', 'cui_str': 'Polythene'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C1260969', 'cui_str': 'Ring, device (physical object)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C3653515', 'cui_str': 'SURGICAL DRESSINGS'}, {'cui': 'C0590323', 'cui_str': 'Gauzes (physical object)'}]",[],458.0,0.25555,"The purpose of this study was to evaluate the efficacy of circular wound protectors in reducing SSI in open abdominal surgery.
","[{'ForeName': 'Ri Na', 'Initials': 'RN', 'LastName': 'Yoo', 'Affiliation': ""Surgery, St. Vincent's Hospital, The Catholic University of Korea, Suwon, The Republic of Korea.""}, {'ForeName': 'Hyung Jin', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': ""Surgery, St. Vincent's Hospital, The Catholic University of Korea, Suwon, The Republic of Korea.""}, {'ForeName': 'Jae Im', 'Initials': 'JI', 'LastName': 'Lee', 'Affiliation': ""Surgery, Uijeongbu St. Mary's Hospital. The Catholic University of Korea, Uijeongbu, The Republic of Korea.""}, {'ForeName': 'Won-Kyung', 'Initials': 'WK', 'LastName': 'Kang', 'Affiliation': ""Surgery, Yeouido St. Mary's Hospital, The Catholic University of Korea, Seoul, The Republic of Korea.""}, {'ForeName': 'Bong-Hyeon', 'Initials': 'BH', 'LastName': 'Kye', 'Affiliation': ""Surgery, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, The Republic of Korea.""}, {'ForeName': 'Chang Woo', 'Initials': 'CW', 'LastName': 'Kim', 'Affiliation': 'Surgery, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, Seoul, The Republic of Korea.'}, {'ForeName': 'Sung Uk', 'Initials': 'SU', 'LastName': 'Bae', 'Affiliation': 'Surgery, School of Medicine, Keimyung University and Dongsan Medical Center, Daegu, The Republic of Korea.'}, {'ForeName': 'Soomin', 'Initials': 'S', 'LastName': 'Nam', 'Affiliation': 'Surgery, National Health Insurance Service Ilsan Hospital, Goyang, The Republic of Korea.'}, {'ForeName': 'Byung Mo', 'Initials': 'BM', 'LastName': 'Kang', 'Affiliation': 'Surgery, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, Chuncheon, The Republic of Korea kbm0728@yahoo.co.kr.'}]",BMJ open,['10.1136/bmjopen-2019-034687']
3513,31980514,"Atorvastatin for prevention of disease progression and hospitalisation in liver cirrhosis: protocol for a randomised, double-blind, placebo-controlled trial.","INTRODUCTION


Patients with liver cirrhosis are often diagnosed late and once complications are present, the 2-year survival is 50%. Increasing evidence supports systemic inflammation and metabolic dysfunction in the hepatic stellate cell as key drivers of progression of cirrhosis. However, there is no registered medication, that targets inflammation and cellular dysfunction in the liver.
METHODS AND ANALYSIS


In a randomised double-blind and placebo-controlled trial with atorvastatin for liver cirrhosis, we aim to investigate clinical endpoints of survival, hospitalisations and safety, but also exploratory endpoints of genomics and protein functions in the liver.
ETHICS AND DISSEMINATION


There is no registered medication that actively prevents development of complications or systemic inflammation in liver cirrhosis. All patients continue regular clinical management during the trial period. Atorvastatin has been on the market for several years with a safety profile that is acceptable even in patients with liver disease. A beneficial effect of atorvastatin on clinical outcomes in cirrhosis will provide cheap and effective causal treatment for chronic liver disease. The trial is registered by the Danish Data Protection Agency (P-2019-635) and approved by the Danish Medicines Agency (EudraCT 2019-001806-40) and the Scientific Ethics Committee of the Capital Region of Denmark (H-19030643) before initiation. Reporting of the trial will follow the Consolidated Standards of Reporting Trials guidelines for reporting of randomised clinical trials.
TRIAL REGISTRATION NUMBER


The trial is registered in clinicaltrials.gov (NCT04072601) and in clinicaltrialsregister.eu (EudraCT 2019-001806-40) (Pre-results).",2020,A beneficial effect of atorvastatin on clinical outcomes in cirrhosis will provide cheap and effective causal treatment for chronic liver disease.,"['liver cirrhosis', 'patients with liver disease']","['placebo', 'atorvastatin', 'Atorvastatin']","['survival, hospitalisations and safety', '2-year survival']","[{'cui': 'C0023890', 'cui_str': 'Hepatic Cirrhosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023895', 'cui_str': 'Disorder of liver (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",,0.620214,A beneficial effect of atorvastatin on clinical outcomes in cirrhosis will provide cheap and effective causal treatment for chronic liver disease.,"[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Kimer', 'Affiliation': 'Gastro Unit, Medical Division, Hvidovre Hospital, Hvidovre, Denmark Nina.kimer@regionh.dk.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Grønbæk', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Rikard Gøran', 'Initials': 'RG', 'LastName': 'Fred', 'Affiliation': 'Novo Nordisk Foundation Centre for Basic Metabolic Research, University of Copenhagen Faculty of Health and Medical Sciences, Kobenhavn, Denmark.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Hansen', 'Affiliation': 'Novo Nordisk Foundation Centre for Basic Metabolic Research, University of Copenhagen Faculty of Health and Medical Sciences, Kobenhavn, Denmark.'}, {'ForeName': 'Atul Shahaji', 'Initials': 'AS', 'LastName': 'Deshmukh', 'Affiliation': 'Clinical Proteomics Group, Proteomics Program, Novo Nordisk Foundation Center for Protein Research, University of Copenhagen, 2200 Copenhagen, Denmark.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Mann', 'Affiliation': 'Clinical Proteomics Group, Proteomics Program, Novo Nordisk Foundation Center for Protein Research, University of Copenhagen, 2200 Copenhagen, Denmark.'}, {'ForeName': 'Flemming', 'Initials': 'F', 'LastName': 'Bendtsen', 'Affiliation': 'Gastro Unit, Medical Division, Hvidovre Hospital, Hvidovre, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-035284']
3514,31959601,Cost-effectiveness of a patient-centred approach to managing multimorbidity in primary care: a pragmatic cluster randomised controlled trial.,"OBJECTIVE


Patients with multiple chronic health conditions are often managed in a disjointed fashion in primary care, with annual review clinic appointments offered separately for each condition. This study aimed to determine the cost-effectiveness of the 3D intervention, which was developed to improve the system of care.
DESIGN


Economic evaluation conducted alongside a pragmatic cluster-randomised trial.
SETTING


General practices in three centres in England and Scotland.
PARTICIPANTS


797 adults with three or more chronic conditions were randomised to the 3D intervention, while 749 participants were randomised to receive usual care.
INTERVENTION


The 3D approach: comprehensive 6-monthly general practitioner consultations, supported by medication reviews and nurse appointments.
PRIMARY AND SECONDARY OUTCOME MEASURES


The primary economic evaluation assessed the cost per quality-adjusted life year (QALY) gained from the perspective of the National Health Service (NHS) and personal social services (PSS). Costs were related to changes in a range of secondary outcomes (QALYs accrued by both participants and carers, and deaths) in a cost-consequences analysis from the perspectives of the NHS/PSS, patients/carers and productivity losses.
RESULTS


Very small increases were found in both QALYs (adjusted mean difference 0.007 (-0.009 to 0.023)) and costs (adjusted mean difference £126 (£-739 to £991)) in the intervention arm compared with usual care after 15 months. The incremental cost-effectiveness ratio was £18 499, with a 50.8% chance of being cost-effective at a willingness-to-pay threshold of £20 000 per QALY (55.8% at £30 000 per QALY).
CONCLUSIONS


The small differences in costs and outcomes were consistent with chance, and the uncertainty was substantial; therefore, the evidence for the cost-effectiveness of the 3D approach from the NHS/PSS perspective should be considered equivocal.
TRIAL REGISTRATION NUMBER


ISCRTN06180958.",2020,Very small increases were found in both QALYs (adjusted mean difference 0.007 (-0.009 to 0.023)) and costs (adjusted mean difference £126 (£-739 to £991)) in the intervention arm compared with usual care after 15 months.,"['General practices in three centres in England and Scotland', 'Patients with multiple chronic health conditions', '797 adults with three or more chronic conditions were randomised to the 3D intervention, while 749 participants', 'primary care']","['usual care', 'patient-centred approach']","['cost-effectiveness', 'Cost-effectiveness', 'incremental cost-effectiveness ratio', 'cost per quality-adjusted life year (QALY) gained from the perspective of the National Health Service (NHS) and personal social services (PSS']","[{'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0037440', 'cui_str': 'Social Welfare'}]",797.0,0.180359,Very small increases were found in both QALYs (adjusted mean difference 0.007 (-0.009 to 0.023)) and costs (adjusted mean difference £126 (£-739 to £991)) in the intervention arm compared with usual care after 15 months.,"[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Thorn', 'Affiliation': 'Centre for Academic Primary Care, Bristol Medical School, University of Bristol, Bristol, UK joanna.thorn@bristol.ac.uk.'}, {'ForeName': 'Mei-See', 'Initials': 'MS', 'LastName': 'Man', 'Affiliation': 'Centre for Academic Primary Care, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Chaplin', 'Affiliation': 'Centre for Academic Primary Care, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bower', 'Affiliation': 'NIHR School for Primary Care Research, Centre for Primary Care and Health Services Research, University of Manchester, Manchester, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Brookes', 'Affiliation': 'Bristol Randomised Trials Collaboration, Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Gaunt', 'Affiliation': 'Bristol Randomised Trials Collaboration, Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Bridie', 'Initials': 'B', 'LastName': 'Fitzpatrick', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Gardner', 'Affiliation': 'NIHR School for Primary Care Research, Centre for Primary Care and Health Services Research, University of Manchester, Manchester, UK.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Guthrie', 'Affiliation': 'Population Health Sciences Division, Medical Research Institute, University of Dundee, Dundee, UK.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Hollinghurst', 'Affiliation': 'Centre for Academic Primary Care, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Lee', 'Affiliation': 'NIHR School for Primary Care Research, Centre for Primary Care and Health Services Research, University of Manchester, Manchester, UK.'}, {'ForeName': 'Stewart W', 'Initials': 'SW', 'LastName': 'Mercer', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Salisbury', 'Affiliation': 'Centre for Academic Primary Care, Bristol Medical School, University of Bristol, Bristol, UK.'}]",BMJ open,['10.1136/bmjopen-2019-030110']
3515,32072735,Dapagliflozin plus saxagliptin add-on to metformin reduces liver fat and adipose tissue volume in patients with type 2 diabetes.,"AIM


To assess the effects of dapagliflozin plus saxagliptin plus metformin versus glimepiride plus metformin on liver fat (proton density fat fraction) and visceral and subcutaneous adipose tissue volumes over 52 weeks of treatment.
MATERIALS AND METHODS


This was a magnetic resonance imaging substudy of a 52-week, multicentre, randomized, double-blind, parallel-group trial that evaluated the efficacy and safety of dapagliflozin 10 mg/day plus saxagliptin 5 mg/day versus titrated glimepiride 1-6 mg (1, 2, 3, 4 or 6 mg) in 82 patients with type 2 diabetes (HbA1c 7.5%-10.5%) on metformin ≥1500 mg/day background. Analyses were exploratory and not controlled for multiplicity; P-values are nominal.
RESULTS


Magnetic resonance imaging was performed on 59 patients; liver fat and adipose tissue volumes were analysed for 59 and 57 patients, respectively. There was a significant >30% reduction from baseline in liver fat (P = 0.007) and >10% reduction in adipose tissue volumes (P < 0.01) with dapagliflozin plus saxagliptin plus metformin at week 52 versus glimepiride plus metformin. In the full-study population, dapagliflozin plus saxagliptin plus metformin decreased body weight and serum alanine aminotransferase and aspartate aminotransferase levels over 52 weeks.
CONCLUSIONS


Dapagliflozin plus saxagliptin significantly decreased liver fat and adipose tissue volume versus glimepiride, and reduced serum liver enzyme levels, indicating a favourable metabolic profile of dapagliflozin plus saxagliptin in patients with type 2 diabetes on metformin therapy.",2020,There was a significant >30% reduction from baseline in liver fat (P=0.007) and >10% reduction in adipose tissue volumes (P<0.01) with dapagliflozin plus saxagliptin plus metformin at week 52 versus glimepiride plus metformin.,"['adult patients with type 2 diabetes (T2D', 'patients with T2D on metformin therapy', 'patients with type 2 diabetes', '82 patients with T2D (HbA1c 7.5%-10.5%) on']","['metformin', 'metformin ≥1,500 mg/day background', 'sodium-glucose cotransporter-2 inhibitor dapagliflozin and the dipeptidyl peptidase-4 inhibitor saxagliptin', 'dapagliflozin 10 mg/day plus saxagliptin', 'Magnetic resonance imaging (MRI', 'glimepiride plus metformin', 'glimepiride', 'dapagliflozin plus saxagliptin plus metformin', 'Dapagliflozin plus saxagliptin', 'dapagliflozin plus saxagliptin']","['adipose tissue volumes', 'body weight and serum alanine aminotransferase and aspartate aminotransferase levels', 'efficacy and safety', 'liver fat (proton density fat fraction [PDFF]) and visceral and subcutaneous adipose tissue volumes', 'liver fat and adipose tissue volumes', 'liver fat', 'serum liver enzyme levels', 'liver fat and adipose tissue volume']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C4517521', 'cui_str': '10.5'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl-Peptidase 4 Inhibitors'}, {'cui': 'C1611934', 'cui_str': 'saxagliptin'}, {'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}]","[{'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0428339', 'cui_str': 'Aspartate transaminase level (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0033727', 'cui_str': 'Hydrogen Ions'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C1287351', 'cui_str': 'Finding of liver enzyme levels (finding)'}]",82.0,0.0592902,There was a significant >30% reduction from baseline in liver fat (P=0.007) and >10% reduction in adipose tissue volumes (P<0.01) with dapagliflozin plus saxagliptin plus metformin at week 52 versus glimepiride plus metformin.,"[{'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Johansson', 'Affiliation': 'Antaros Medical AB, BioVenture Hub, Mölndal, Sweden.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Hockings', 'Affiliation': 'Antaros Medical AB, BioVenture Hub, Mölndal, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Johnsson', 'Affiliation': 'Global Medicines Development, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Nalina', 'Initials': 'N', 'LastName': 'Dronamraju', 'Affiliation': 'Global Medicines Development, AstraZeneca, Gaithersburg, Maryland, United States.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Maaske', 'Affiliation': 'Global Medicines Development, AstraZeneca, Gaithersburg, Maryland, United States.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Garcia-Sanchez', 'Affiliation': 'Global Medicines Development, AstraZeneca, Gaithersburg, Maryland, United States.'}, {'ForeName': 'John P H', 'Initials': 'JPH', 'LastName': 'Wilding', 'Affiliation': 'Obesity and Endocrinology Research Group, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, United Kingdom.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14004']
3516,31470798,Comparison of disinfection effect between benzalkonium chloride and povidone iodine in nasotracheal intubation: a randomized trial.,"BACKGROUND


Nasotracheal intubation can potentially result in microbial contamination from the upper respiratory tract to the lower respiratory tracts. However, an ideal nasotracheal disinfection method is yet to be determined. Therefore, we compared the disinfection effects between benzalkonium chloride and povidone iodine in nasotracheal intubation.
METHODS


Overall, this study enrolled 53 patients aged 20-70 years who were classified into classes 1 and 2 as per American Society of Anesthesiologists-physical status and were scheduled to undergo general anesthesia with NTI. Patients who did not give consent (n = 2) and who has an allergy for BZK or PVI were excluded from the study. The patients were randomly divided into two groups on the basis of the disinfection method: BZK (n = 26, one patient was discontinued intervention) and PVI (n = 25). 50 patients were assessed finally. The subjects' nasal cavities were swabbed both before (A) and after disinfection (B), and the internal surface of the endotracheal tube was swabbed after extubation (C). The swabs were cultured on Brain heart infusion agar and Mannitol salt agar. The number of bacteria per swab was determined and the rates of change in bacterial count (B/A, C/B) were calculated. The growth inhibitory activity of the disinfectants on Staphylococcus aureus were also investigated in vitro.
RESULTS


Although the initial disinfection effects (B/A) were inferior for benzalkonium chloride compared with those for povidone iodine, the effects were sustained for benzalkonium chloride (C/B). In the in vitro growth inhibitory assay against S. aureus, benzalkonium chloride showed higher inhibitory activity than povidone iodine.
CONCLUSION


Although both disinfectants were inactivated or diffused/diluted over time, benzalkonium chloride maintained the threshold concentration and displayed antimicrobial effects longer than povidone iodine; therefore, benzalkonium chloride appeared to show a better sustained effect. Benzalkonium chloride can be used for creating a hygienic nasotracheal intubation environment with sustained sterilizing effects.
TRIAL REGISTRATION


UMIN-CTR (Registration No. UMIN000029645 ). Registered 21 Oct 2017.",2019,"In the in vitro growth inhibitory assay against S. aureus, benzalkonium chloride showed higher inhibitory activity than povidone iodine.
","['Patients who did not give consent (n\u2009=\u20092) and who has an allergy for BZK or PVI were excluded from the study', 'nasotracheal intubation', '50 patients were assessed finally', '53 patients aged 20-70\u2009years who were classified into classes 1 and 2 as per American Society of Anesthesiologists-physical status and were scheduled to undergo general anesthesia with NTI']","['Benzalkonium chloride', 'benzalkonium chloride and povidone iodine', 'benzalkonium chloride', 'povidone iodine']","['inhibitory activity', 'number of bacteria per swab']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0002111', 'cui_str': 'Allergy Specialty'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation (procedure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0441885', 'cui_str': 'Class 1 (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}]","[{'cui': 'C0005026', 'cui_str': 'Benzalkonium Chloride'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}, {'cui': 'C1261188', 'cui_str': 'Swab (physical object)'}]",53.0,0.0597403,"In the in vitro growth inhibitory assay against S. aureus, benzalkonium chloride showed higher inhibitory activity than povidone iodine.
","[{'ForeName': 'Aiji', 'Initials': 'A', 'LastName': 'Sato-Boku', 'Affiliation': 'Department of Anesthesiology, Aichi Gakuin University School of Dentistry, 2-11 Suemori-dori, Chikusa-ku, Nagoya, 464-8651, Japan. bokuaiji@dpc.agu.ac.jp.'}, {'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Nagano', 'Affiliation': 'Department of Oral microbiology, School of Dentistry Health Sciences University of Hokkaido 757 Kanazawa, Ishikari-Tobetsu, Hokkaido, 061-0293, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Microbiology, Aichi Gakuin University School of Dentistry, 1-100 Kusumotocho, Chikusa-ku, Nagoya, 464-8650, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Kamimura', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Sento', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.'}, {'ForeName': 'MinHye', 'Initials': 'M', 'LastName': 'So', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.'}, {'ForeName': 'Eisuke', 'Initials': 'E', 'LastName': 'Kako', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Okuda', 'Affiliation': 'Department of Anesthesiology, Aichi Gakuin University School of Dentistry, 2-11 Suemori-dori, Chikusa-ku, Nagoya, 464-8651, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Tachi', 'Affiliation': 'Department of Anesthesiology, Aichi Gakuin University School of Dentistry, 2-11 Suemori-dori, Chikusa-ku, Nagoya, 464-8651, Japan.'}, {'ForeName': 'Hidekazu', 'Initials': 'H', 'LastName': 'Ito', 'Affiliation': 'Department of Anesthesiology, Aichi Developmental Disability Center Central Hospital, 713-8 Kagiya-cho, Kasugai-city, Aichi, 480-0392, Japan.'}, {'ForeName': 'Yushi', 'Initials': 'Y', 'LastName': 'Adachi', 'Affiliation': 'Department of Anesthesiology, Nagoya University Graduate School of Medicine, 65 Tsurumaicho, Showaku, Nagoya, 466-8550, Japan.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Sobue', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.'}]",BMC anesthesiology,['10.1186/s12871-019-0839-y']
3517,31470813,Multimodal analgesia with ropivacaine wound infiltration and intravenous flurbiprofen axetil provides enhanced analgesic effects after radical thyroidectomy: a randomized controlled trial.,"BACKGROUND


Thyroidectomy is a common procedure that causes mild trauma. Nevertheless, postoperative pain remains a major challenge in patient care. Multimodal analgesia comprising a combination of analgesics and analgesic techniques has become increasingly popular for the control of postoperative pain. The present study tested the hypothesis that multimodal analgesia with combined ropivacaine wound infiltration and intravenous flurbiprofen axetil after radical thyroidectomy provided better analgesia than a single dosage of tramadol.
METHODS


This randomized controlled trial was conducted in a tertiary hospital. Forty-four patients (age, 18-75 years; American Society of Anesthesiologists status I or II; BMI < 32 kg/m 2 ) scheduled for radical thyroidectomy were randomly assigned to a multimodal analgesia group (Group M) or a control group (Group C) by random numbers assignments, and 40 patients completed the study. All participants and the nurse in charge of follow-up observations were blinded to group assignment. Anesthesia was induced with sufentanil, propofol, and cisatracurium. After tracheal intubation, Group M received pre-incision wound infiltration with 5 ml of 0.5% ropivacaine mixed with epinephrine at 1:200,000 (5 μg/ml); Group C received no wound infiltration. Anesthesia was maintained with target-controlled infusion of propofol, remifentanil, sevoflurane, and intermittent cisatracurium. Twenty minutes before the end of surgery, Group M received 100 mg flurbiprofen axetil while Group C received 100 mg tramadol. Postoperative pain was evaluated with the numerical rating scale (NRS) pain score. Remifentanil consumption, heart rate, and noninvasive blood pressure were recorded intraoperatively. Adverse events were documented. The primary outcome was analgesic effect according to NRS scores.
RESULTS


NRS scores at rest were significantly lower in Group M than in Group C before discharge from the postoperative anesthetic care unit (P = 0.003) and at 2 (P = 0.008), 4 (P = 0.020), and 8 h (P = 0.016) postoperatively. Group M also had significantly lower NRS scores during coughing/swallowing at 5 min after extubation (P = 0.017), before discharge from the postoperative anesthetic care unit (P = 0.001), and at 2 (P = 0.002) and 4 h (P = 0.013) postoperatively. Compared with Group C, NRS scores were significantly lower throughout the first 24 h postoperatively in Group M at rest (P = 0.008) and during coughing/swallowing (P = 0.003). No serious adverse events were observed in either group.
CONCLUSION


Multimodal analgesia with ropivacaine wound infiltration and intravenous flurbiprofen axetil provided better analgesia than tramadol after radical thyroidectomy.
TRIAL REGISTRATION


Chinese Clinical Trial Registry (registration number # ChiCTR1800020290 ; date of registration: 22/12/2018).",2019,"RESULTS


NRS scores at rest were significantly lower in Group M than in Group C before discharge from the postoperative anesthetic care unit (P = 0.003) and at 2 (P = 0.008), 4 (P = 0.020), and 8 h (P = 0.016) postoperatively.","['radical thyroidectomy', 'Forty-four patients (age, 18-75\u2009years', 'American Society of Anesthesiologists status I or II; BMI\u2009<\u200932\u2009kg/m 2 ) scheduled for radical thyroidectomy']","['flurbiprofen', 'multimodal analgesia group (Group M) or a control group', 'propofol, remifentanil, sevoflurane, and intermittent cisatracurium', 'sufentanil, propofol, and cisatracurium', 'ropivacaine', 'flurbiprofen axetil', 'pre-incision wound infiltration with 5\u2009ml of 0.5% ropivacaine mixed with epinephrine', 'axetil', 'tramadol']","['analgesic effect according to NRS scores', 'serious adverse events', 'numerical rating scale (NRS) pain score', 'Postoperative pain', 'Adverse events', 'Remifentanil consumption, heart rate, and noninvasive blood pressure', 'NRS scores', 'analgesic effects']","[{'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0016377', 'cui_str': 'Flurbiprofen'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441847', 'cui_str': 'Group M (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C1096766', 'cui_str': 'Cisatracurium'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C1610514', 'cui_str': 'flurbiprofen axetil'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0394871', 'cui_str': 'Wound infiltration (procedure)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}]","[{'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0222045'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",44.0,0.190827,"RESULTS


NRS scores at rest were significantly lower in Group M than in Group C before discharge from the postoperative anesthetic care unit (P = 0.003) and at 2 (P = 0.008), 4 (P = 0.020), and 8 h (P = 0.016) postoperatively.","[{'ForeName': 'Xiaoxi', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Anesthesiology, Peking University Cancer Hospital & Institute, #52 Fucheng Street, Haidian District, Beijing, 100142, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Anesthesiology, Peking University Cancer Hospital & Institute, #52 Fucheng Street, Haidian District, Beijing, 100142, China.'}, {'ForeName': 'Jiaonan', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Anesthesiology, Peking University Cancer Hospital & Institute, #52 Fucheng Street, Haidian District, Beijing, 100142, China.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Tan', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Anesthesiology, Peking University Cancer Hospital & Institute, #52 Fucheng Street, Haidian District, Beijing, 100142, China. maggitan@163.com.'}]",BMC anesthesiology,['10.1186/s12871-019-0835-2']
3518,31757774,"Safety and immunogenicity of the oral, inactivated, enterotoxigenic Escherichia coli vaccine ETVAX in Bangladeshi children and infants: a double-blind, randomised, placebo-controlled phase 1/2 trial.","BACKGROUND


Enterotoxigenic Escherichia coli causes diarrhoea, leading to substantial mortality and morbidity in children, but no specific vaccine exists. This trial tested an oral, inactivated, enterotoxigenic E coli vaccine (ETVAX), which has been previously shown to be safe and highly immuongenic in Swedish and Bangladeshi adults. We tested the safety and immunogenicity of ETVAX, consisting of four E coli strains overexpressing the most prevalent colonisation factors (CFA/I, CS3, CS5, and CS6) and a toxoid (LCTBA) administered with or without a double-mutant heat-labile enterotoxin (dmLT) as an adjuvant, in Bangladeshi children.
METHODS


We did a randomised, double-blind, placebo-controlled, dose-escalation, age-descending, phase 1/2 trial in Dhaka, Bangladesh. Healthy children in one of three age groups (24-59 months, 12-23 months, and 6-11 months) were eligible. Children were randomly assigned with block randomisation to receive either ETVAX, with or without dmLT, or placebo. ETVAX (half [5·5 × 10 10  cells], quarter [2·5 × 10 10  cells], or eighth [1·25 × 10 10  cells] adult dose), with or without dmLT adjuvant (2·5 μg, 5·0 μg, or 10·0 μg), or placebo were administered orally in two doses 2 weeks apart. Investigators and participants were masked to treatment allocation. The primary endpoint was safety and tolerability, assessed in all children who received at least one dose of vaccine. Antibody responses to vaccine antigens, defined as at least a two-times increase in antibody levels between baseline and post-immunisation, were assessed as secondary endpoints. This trial is registered with ClinicalTrials.gov, NCT02531802.
FINDINGS


Between Dec 7, 2015, and Jan 10, 2017, we screened 1500 children across the three age groups, of whom 430 were enrolled and randomly assigned to the different treatment groups (130 aged 24-59 months, 100 aged 12-23 months, and 200 aged 6-11 months). All participants received at least one dose of vaccine. No solicited adverse events occurred that were greater than moderate in severity, and most were mild. The most common solicited event was vomiting (ten [8%] of 130 patients aged 24-59 months, 13 [13%] of 100 aged 12-23 months, and 29 [15%] of 200 aged 6-11 months; mostly of mild severity), which appeared related to dose and age. The addition of dmLT did not modify the safety profile. Three serious adverse events occurred but they were not considered related to the study drug. Mucosal IgA antibody responses in lymphocyte secretions were detected against all primary vaccine antigens (CFA/I, CS3, CS5, CS6, and the LCTBA toxoid) in most participants in the two older age groups, whereas such responses to four of the five antigens were less frequent and of lower magnitude in infants aged 6-11 months than in older children. Faecal secretory IgA immune responses were recorded against all vaccine antigens in infants aged 6-11 months. 78 (56%) of 139 infants aged 6-11 months who were vaccinated developed mucosal responses against at least three of the vaccine antigens versus 14 (29%) of 49 of the infants given placebo. Addition of the adjuvant dmLT enhanced the magnitude, breadth, and kinetics (based on number of responders after the first dose of vaccine) of immune responses in infants.
INTERPRETATION


The encouraging safety and immunogenicity of ETVAX and benefit of dmLT adjuvant in young children support its further assessment for protective efficacy in children in enterotoxigenic E coli-endemic areas.
FUNDING


PATH (Bill & Melinda Gates Foundation and the UK's Department for International Development), the Swedish Research Council, and The Swedish Foundation for Strategic Research.",2020,Mucosal IgA antibody responses in lymphocyte secretions were detected against all primary vaccine antigens (,"['Swedish and Bangladeshi adults', '78 (56%) of 139 infants aged 6-11 months', 'Bangladeshi children and infants', 'Healthy children in one of three age groups (24-59 months, 12-23 months, and 6-11 months) were eligible', 'Bangladeshi children', 'infants', 'young children', 'Between Dec 7, 2015, and Jan 10, 2017, we screened 1500 children across the three age groups, of whom 430 were enrolled and randomly assigned to the different treatment groups (130 aged 24-59 months, 100 aged 12-23 months, and 200 aged 6-11 months', 'children in enterotoxigenic E coli-endemic areas']","['ETVAX, with or without dmLT, or placebo', 'enterotoxigenic Escherichia coli vaccine ETVAX', 'dmLT adjuvant', 'ETVAX', 'placebo', 'dmLT adjuvant (2·5 μg, 5·0 μg, or 10·0 μg), or placebo', 'vaccine', 'toxoid (LCTBA) administered with or without a double-mutant heat-labile enterotoxin (dmLT', 'inactivated, enterotoxigenic E coli vaccine (ETVAX']","['mucosal responses', 'solicited adverse events', 'Safety and immunogenicity', 'magnitude, breadth, and kinetics', 'vomiting', 'antibody levels', 'Faecal secretory IgA immune responses', 'Mucosal IgA antibody responses', 'serious adverse events', 'safety and tolerability']","[{'cui': 'C0422784', 'cui_str': 'Bangladeshi'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0580797', 'cui_str': 'E coli, Enterotoxigenic'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0580797', 'cui_str': 'E coli, Enterotoxigenic'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0040555', 'cui_str': 'Toxoids'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0014372', 'cui_str': 'Enterotoxins'}]","[{'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0020838', 'cui_str': 'Secretory IgA'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}]",1500.0,0.671173,Mucosal IgA antibody responses in lymphocyte secretions were detected against all primary vaccine antigens (,"[{'ForeName': 'Firdausi', 'Initials': 'F', 'LastName': 'Qadri', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Marjahan', 'Initials': 'M', 'LastName': 'Akhtar', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Taufiqur R', 'Initials': 'TR', 'LastName': 'Bhuiyan', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Mohiul I', 'Initials': 'MI', 'LastName': 'Chowdhury', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Tasnuva', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Tanzeem A', 'Initials': 'TA', 'LastName': 'Rafique', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Arifuzzaman', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Sadia I A', 'Initials': 'SIA', 'LastName': 'Rahman', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Farhana', 'Initials': 'F', 'LastName': 'Khanam', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lundgren', 'Affiliation': 'Gothenburg University Vaccine Research Institute, Department of Microbiology and Immunology, Institute of Biomedicine, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Wiklund', 'Affiliation': 'Gothenburg University Vaccine Research Institute, Department of Microbiology and Immunology, Institute of Biomedicine, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Kaim', 'Affiliation': 'Gothenburg University Vaccine Research Institute, Department of Microbiology and Immunology, Institute of Biomedicine, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Löfstrand', 'Affiliation': 'Gothenburg University Vaccine Research Institute, Department of Microbiology and Immunology, Institute of Biomedicine, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Carlin', 'Affiliation': 'Scandinavian Biopharma, Solna, Sweden.'}, {'ForeName': 'A Louis', 'Initials': 'AL', 'LastName': 'Bourgeois', 'Affiliation': 'PATH, Washington DC, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Maier', 'Affiliation': 'PATH, Washington DC, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Fix', 'Affiliation': 'PATH, Washington DC, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wierzba', 'Affiliation': 'PATH, Washington DC, USA; Wake Forest School of Medicine, Section on Infectious Diseases, Department of Internal Medicine, Winston Salem, NC, USA.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Walker', 'Affiliation': 'PATH, Washington DC, USA.'}, {'ForeName': 'Ann-Mari', 'Initials': 'AM', 'LastName': 'Svennerholm', 'Affiliation': 'Gothenburg University Vaccine Research Institute, Department of Microbiology and Immunology, Institute of Biomedicine, University of Gothenburg, Gothenburg, Sweden. Electronic address: ann-mari.svennerholm@microbio.gu.se.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30571-7']
3519,32113008,Force stability training decreased force variability of plantar flexor muscles without reducing postural sway in female older adults.,"BACKGROUND


Previous studies reported a relationship between postural sway and force variability of the plantar flexor muscles (PFM), such that less force variability related to lower postural sway; however, this association does not seem to exist in older adults.
RESEARCH QUESTION


This study investigated the effect of force stability training of the PFM on force variability (FV) of these muscles and postural sway in female older adults.
METHODS


Thirty female older adults were divided into three groups: TG5 (n = 10), who trained at 5% of maximum voluntary isometric contraction (MVIC) of the PFM; TG10 (n = 10), who trained at 10 % of MVIC of the PFM; and CG (n = 10) who did not perform any specific training for the PFM. Postural sway was evaluated during upright bipodal posture. Postural sway and FV of the PFM were assessed before and after the training period. Participants trained once a week for four weeks.
RESULTS


After the training period, the FV decreased significantly for both TG5 (pre = 3.26 ± 0.83; post = 2.53 ± 0.60 N) and TG10 (pre = 3.50 ± 0.72; post = 2.85 ± 0.86 N), but the mean sway amplitude increased for both TG5 (pre = 0.017 ± 0.03; post = 0.19 ± 0.04 cm) and TG10 (pre = 0.14 ± 0.04; post = 0.16 ± 0.04 cm).
SIGNIFICANCE


The force stability training decreased the FV of the PFM, but this decrease was insufficient to reduce postural sway in female older adults.",2020,"The force stability training decreased the FV of the PFM, but this decrease was insufficient to reduce postural sway in female older adults.","['Thirty female older adults', 'female older adults', 'older adults']","['TG5', 'PFM', 'maximum voluntary isometric contraction (MVIC) of the PFM; TG10 (n\u2009=\u200910), who trained at 10 % of MVIC of the PFM; and CG (n\u2009=\u200910) who did not perform any specific training for the PFM', 'Force stability training']","['Postural sway', 'Postural sway and FV of the PFM', 'mean sway amplitude', 'postural sway']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0022205', 'cui_str': 'Isometric Contraction'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0591126', 'cui_str': 'AT 10'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}]","[{'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",30.0,0.0482629,"The force stability training decreased the FV of the PFM, but this decrease was insufficient to reduce postural sway in female older adults.","[{'ForeName': 'Roberto N', 'Initials': 'RN', 'LastName': 'Barbosa', 'Affiliation': 'School of Physical Education and Sport of Ribeirão Preto, University of São Paulo, São Paulo, Brazil. Electronic address: robertonegri@usp.br.'}, {'ForeName': 'Nilson R S', 'Initials': 'NRS', 'LastName': 'Silva', 'Affiliation': 'School of Physical Education and Sport of Ribeirão Preto, University of São Paulo, São Paulo, Brazil. Electronic address: nilsonribeiro@usp.br.'}, {'ForeName': 'Daniel P R', 'Initials': 'DPR', 'LastName': 'Santos', 'Affiliation': 'School of Physical Education and Sport of Ribeirão Preto, University of São Paulo, São Paulo, Brazil. Electronic address: danielpeterossi@usp.br.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Moraes', 'Affiliation': 'School of Physical Education and Sport of Ribeirão Preto, University of São Paulo, São Paulo, Brazil. Electronic address: renatomoraes@usp.br.'}, {'ForeName': 'Matheus M', 'Initials': 'MM', 'LastName': 'Gomes', 'Affiliation': 'School of Physical Education and Sport of Ribeirão Preto, University of São Paulo, São Paulo, Brazil. Electronic address: mmgomes@usp.br.'}]",Gait & posture,['10.1016/j.gaitpost.2020.02.015']
3520,32142501,"What Is the Effect of Vitamin C on Finger Stiffness After Distal Radius Fracture? A Double-blind, Placebo-controlled Randomized Trial.","BACKGROUND


It is proposed that vitamin C administration can reduce disproportionate pain and stiffness after distal radius fracture; however, randomized trials that tested this hypothesis have had inconsistent results.
QUESTIONS/PURPOSES


(1) Is administering vitamin C after distal radius fracture associated with better ROM, patient-reported upper extremity function, and pain scores? (2) What factors are associated with post-fracture finger stiffness and worse upper extremity function?
METHODS


This is a double-blind, randomized, placebo-controlled, noncrossover study. Between August 2014 and July 2017, we approached 204 consecutive patients, of which 195 were eligible, and 134 chose to participate. Participants were randomized to receive once-daily 500 mg vitamin C (67 participants) or placebo (67 participants) within 2 weeks after distal radius fracture. All patients received usual care at the discretion of their surgeon. The mean age of participants was 49 ± 17 years, 99 patients (74%) were women, and 83 (62%) were treated nonoperatively. The primary outcome was the distance between the fingertip and distal palmar crease 6 weeks after fracture. This measure is easy to obtain and previously has been shown to correlate with aggregate ROM of all finger joints. The secondary outcomes were total active finger motion, total active thumb motion, upper extremity-specific limitations, and pain intensity.An a priori power analysis suggested 126 patients would provide 80% power to detect a difference of 2 cm (SD 4.0) fingertip distance to palmar crease with α set at 0.05 using a two-tailed Student's t-test. Accounting for 5% lost to followup, we included 134 patients.All analyses were intention-to-treat. Ten participants of the intervention group and five of the placebo group were lost to followup. Their missing data were addressed by multiple imputation, after which we performed linear regression analysis for our outcome variables.
RESULTS


Administration of vitamin C was not associated with ROM, function, or pain scores at 6 weeks (distance to palmar crease: β -0.23; 95% CI -1.7 to 1.2; p = 0.754; finger ROM: β 4.9; 95% CI, -40 to 50; p = 0.829; thumb ROM: β 0.98; 95% CI, -18 to 20; p = 0.918, Patient-Reported Outcomes Measurement Information System [PROMIS] score: β 0.32; 95% CI, -2.6 to 3.2; p = 0.828; pain score: β -0.62; 95% CI, -0.62 to 0.89; p = 0.729) nor at 6 months (PROMIS score: β -0.21; 95% CI, -3.7 to 3.3; p = 0.904; pain score: β 0.31; 95% CI, -0.74 to 1.4; p = 0.559). At 6 weeks, we found that more finger stiffness was mildly associated with greater age (β -1.5; 95% CI, -2.8 to -0.083; p = 0.038). Thumb stiffness was mildly associated with greater age (β -0.72; 95% CI, -1.3 to -0.18; p = 0.009) and strongly associated with operative treatment (β -32; 95% CI, -50 to -13; p = 0.001). Greater pain interference was modestly associated with greater functional limitations at 6 weeks (β -0.32; 95% CI, -0.52 to -0.12; p = 0.002) and 6 months (β -0.36; 95% CI, -0.60 to -0.11; p = 0.004).
CONCLUSIONS


Vitamin C does not seem to facilitate recovery after distal radius fracture, but amelioration of maladaptation to nociception (pain interference) merits greater attention.
LEVEL OF EVIDENCE


Level I, therapeutic study.",2019,"Thumb stiffness was mildly associated with greater age (β -0.72; 95% CI, -1.3 to -0.18; p = 0.009) and strongly associated with operative treatment (","['The mean age of participants was 49 ± 17 years, 99 patients (74%) were women, and 83 (62%) were treated nonoperatively', '134 patients', 'Between August 2014 and July 2017, we approached 204 consecutive patients, of which 195 were eligible, and 134 chose to participate']","['Vitamin C', 'Placebo', 'placebo', 'vitamin C administration', 'vitamin C']","['Greater pain interference', 'ROM, function, or pain scores', 'Thumb stiffness', 'finger stiffness', 'total active finger motion, total active thumb motion, upper extremity-specific limitations, and pain intensity', 'distance between the fingertip and distal palmar crease 6 weeks after fracture', 'Finger Stiffness']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0647859', 'cui_str': 'AM49'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0040067', 'cui_str': 'Thumb'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0239596'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0016129', 'cui_str': 'Fingers'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0424730', 'cui_str': 'Finding of palmar crease'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}]",204.0,0.596166,"Thumb stiffness was mildly associated with greater age (β -0.72; 95% CI, -1.3 to -0.18; p = 0.009) and strongly associated with operative treatment (","[{'ForeName': 'Sezai', 'Initials': 'S', 'LastName': 'Özkan', 'Affiliation': 'S. Özkan, Hand and Upper Extremity Service, Department of Orthopedic Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA; Department of Trauma Surgery, VU University Medical Center, Amsterdam, the Netherlands T. Teunis, Department of Plastic Surgery, University Medical Center Utrecht, Utrecht, the Netherlands D. C. Ring, Department of Surgery and Perioperative Care, Dell Medical School, The University of Texas at Austin, Austin, TX, USA N. C. Chen, Hand and Upper Extremity Service, Department of Orthopedic Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Teun', 'Initials': 'T', 'LastName': 'Teunis', 'Affiliation': ''}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Ring', 'Affiliation': ''}, {'ForeName': 'Neal C', 'Initials': 'NC', 'LastName': 'Chen', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000000807']
3521,31376501,The Differential Contribution of the Components of Parent-Child Interaction Therapy Emotion Development for Treatment of Preschool Depression.,"OBJECTIVE


An adaptation of Parent-Child Interaction Therapy (PCIT) with a novel Emotion Development (ED) module has shown efficacy for the treatment of early childhood depression. Children who received PCIT-ED also showed healthy alterations in neural response to reward. We investigated whether the novel ED module made a unique contribution to the treatment of depression and neural response to reward, and whether child-directed intervention (CDI) and parent-directed intervention (PDI) modules (standard elements of PCIT) were also effective.
METHOD


Dyads who participated in a randomized controlled trial of PCIT that compared the active PCIT-ED to a wait list (WL) condition were assessed at the completion of each module of PCIT-ED (CDI, PDI, ED) or WL time equivalent for child depression and other symptoms, parenting styles, stress, and depression. Event-related potentials during a reward task were obtained at the end of standard PCIT and after the novel ED module.
RESULTS


Study findings showed that the ED module as well as some elements of standard PCIT were effective in reducing child depression and other forms of psychopathology. Changes in the child's neural response to reward and parental response to child emotional expression were specific to the ED module.
CONCLUSION


Study findings suggest that the novel ED module has added efficacy for the treatment of early childhood depression, as well as unique efficacy in changing neural responses to reward and parenting response to child emotional expression. These findings can inform clinical uses of this treatment in a modular fashion. Future studies are needed that control for session number and order of PCIT-ED modules.
CLINICAL TRIAL REGISTRATION INFORMATION


A Randomized Controlled Trial of PCIT-ED for Preschool Depression; https://clinicaltrials.gov/; NCT02076425.",2019,"Changes in the child's neural response to reward and parental response to child emotional expression were specific to the ED module.
","['Dyads who participated in a randomized controlled trial of', 'Preschool Depression']","['Parent Child Interaction Therapy (PCIT) with a novel Emotion Development(ED', 'PCIT', 'child directed intervention (CDI) and parent directed intervention (PDI) modules (standard elements of PCIT', 'active PCIT-ED', 'PCIT-ED']","['Event related potentials (ERPs', 'child depression', 'PCIT-ED (CDI, PDI, ED) or WL time equivalent for child depression and other symptoms, parenting styles, stress, and depression']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013879', 'cui_str': 'Elements'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0282171', 'cui_str': 'Potentials, Event-Related'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]",,0.0574789,"Changes in the child's neural response to reward and parental response to child emotional expression were specific to the ED module.
","[{'ForeName': 'Joan L', 'Initials': 'JL', 'LastName': 'Luby', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO. Electronic address: lubyj@wustl.edu.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Gilbert', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Whalen', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Tillman', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Deanna M', 'Initials': 'DM', 'LastName': 'Barch', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.07.937']
3522,30824961,Prophylactic Intraperitoneal Onlay Mesh Following Midline Laparotomy-Long-Term Results of a Randomized Controlled Trial.,"OBJECTIVES


Incisional hernia, a serious complication after laparotomy, is associated with high morbidity and costs. This trial examines the value of prophylactic intraperitoneal onlay mesh to reduce the risk of incisional hernia after a median follow-up time of 5.3 years.
METHODS


We conducted a parallel group, open-label, single center, randomized controlled trial (NCT01003067). After midline incision, the participants were either allocated to abdominal wall closure according to Everett with a PDS-loop running suture reinforced by an intraperitoneal composite mesh strip (Group A) or the same procedure without the additional mesh strip (Group B).
RESULTS


A total of 276 patients were randomized (Group A = 131; Group B = 136). Follow-up data after a median of 5.3 years after surgery were available from 183 patients (Group A = 95; Group B = 88). Incisional hernia was diagnosed in 25/95 (26%) patients in Group A and in 46/88 (52%) patients in Group B (risk ratio 0.52; 95% CI 0.36-0.77; p < 0.001). Eighteen patients with asymptomatic incisional hernia went for watchful waiting instead of hernia repair and remained free of symptoms after of a median follow-up of 5.1 years. Between the second- and fifth-year follow-up period, no complication associated with the mesh could be detected.
CONCLUSION


The use of a composite mesh in intraperitoneal onlay position significantly reduces the risk of incisional hernia during a 5-year follow-up period.
TRIAL REGISTRATION NUMBER


Ref. NCT01003067 (clinicaltrials.gov).",2019,Eighteen patients with asymptomatic incisional hernia went for watchful waiting instead of hernia repair and remained free of symptoms after of a median follow-up of 5.1 years.,"['Eighteen patients with asymptomatic incisional hernia went for watchful waiting instead of hernia repair and remained free of symptoms after of a median follow-up of 5.1\xa0years', '276 patients']","['prophylactic intraperitoneal onlay mesh', 'composite mesh in intraperitoneal onlay position', 'abdominal wall closure according to Everett with a PDS-loop running suture reinforced by an intraperitoneal composite mesh strip (Group A) or the same procedure without the additional mesh strip', 'Prophylactic Intraperitoneal Onlay Mesh']","['risk of incisional hernia', 'Incisional hernia']","[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0267716', 'cui_str': 'Postoperative Hernia'}, {'cui': 'C0700325', 'cui_str': 'Waitings, Watchful'}, {'cui': 'C0019328', 'cui_str': 'Hernia Repair'}, {'cui': 'C0436342', 'cui_str': 'Free of symptoms'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal (qualifier value)'}, {'cui': 'C0677511', 'cui_str': 'Onlay (qualifier value)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C1542047', 'cui_str': 'Abdomen closure'}, {'cui': 'C0445022', 'cui_str': 'Loop (qualifier value)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C1321564', 'cui_str': 'Strip'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0267716', 'cui_str': 'Postoperative Hernia'}]",276.0,0.265185,Eighteen patients with asymptomatic incisional hernia went for watchful waiting instead of hernia repair and remained free of symptoms after of a median follow-up of 5.1 years.,"[{'ForeName': 'Philippe M', 'Initials': 'PM', 'LastName': 'Glauser', 'Affiliation': 'Department of Surgery, Hospital of Baselland, University of Basel, Liestal, Switzerland.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Brosi', 'Affiliation': 'Department of Surgery, Hospital of Baselland, University of Basel, Liestal, Switzerland.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Speich', 'Affiliation': 'Department of Surgery, Hospital of Baselland, University of Basel, Liestal, Switzerland.'}, {'ForeName': 'Samuel A', 'Initials': 'SA', 'LastName': 'Käser', 'Affiliation': 'Department of Surgery, Hospital of Baselland, University of Basel, Liestal, Switzerland.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Heigl', 'Affiliation': 'Department of Surgery, Hospital of Baselland, University of Basel, Liestal, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Rosenberg', 'Affiliation': 'Department of Surgery, Hospital of Baselland, University of Basel, Liestal, Switzerland.'}, {'ForeName': 'Christoph A', 'Initials': 'CA', 'LastName': 'Maurer', 'Affiliation': 'Department of Surgery, Hospital of Baselland, University of Basel, Liestal, Switzerland. christoph.maurer@hin.ch.'}]",World journal of surgery,['10.1007/s00268-019-04964-6']
3523,32128909,Cancer worry and empathy moderate the effect of a survivorship-focused intervention on quality of life.,"OBJECTIVE


This study examined the impact of a survivorship planning consultation (SPC) for patients with Hodgkin's lymphoma and diffuses large B-cell lymphoma on quality of life (QOL). We specifically assessed two potential moderators, cancer worry and perceived empathy, of the intervention effects on QOL.
METHODS


This cluster randomized, four-site trial examined the efficacy of a SPC; physicians received communication skills training and applied these skills in a survivorship-focused office visit using a care plan vs a control arm in which physicians were trained to and subsequently provided a time-controlled, manualized wellness rehabilitation consultation focused only on discussion of healthy nutrition and exercise. We examined the effect of the intervention on patients' QOL and examined potential moderators-cancer worry and perceived physician empathy.
RESULTS


Forty-two physicians and 198 patients participated. There was no main effect of the intervention on any of the QOL dimensions (ps > 0.10). However, cancer worry was a significant moderator of the effects of the intervention on three QOL domains (physical P = .04; social P = .04; spiritual P = .01) and perceived empathy was a significant moderator of QOL (physical P = .004; psychological P = .04; social P = .01). Specifically, the beneficial effects of the intervention were more pronounced among patients who initially reported higher levels of cancer worry and lower levels of physician empathy.
CONCLUSIONS


This study identified two factors, perceived empathy and cancer worry, that were found to impact the QOL of patients who participated in this communication-based survivorship intervention.",2020,There was no main effect of the intervention on any of the QOL dimensions (ps > 0.10).,"['Forty-two physicians and 198 patients participated', ""patients with Hodgkin's lymphoma (HL) and diffuse large B-cell lymphoma (DLBCL"", 'patients who participated in this communication-based survivorship intervention']","['manualized Wellness Rehabilitation Consultation (WRC) focused only on discussion of healthy nutrition and exercise', 'survivorship planning consultation (SPC', 'communication skills training']","['QOL dimensions', 'quality of life', 'cancer worry and lower levels of physician empathy', 'quality of life (QOL']","[{'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1266193', 'cui_str': 'Hodgkin lymphoma - category (morphologic abnormality)'}, {'cui': 'C0079744', 'cui_str': 'Diffuse Large-Cell Lymphoma'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038955'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0038955'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C4521398', 'cui_str': 'US Military enlisted E4'}, {'cui': 'C0588407', 'cui_str': 'Communication skills training (procedure)'}]","[{'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}]",198.0,0.0188331,There was no main effect of the intervention on any of the QOL dimensions (ps > 0.10).,"[{'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Parker', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Smita C', 'Initials': 'SC', 'LastName': 'Banerjee', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Matasar', 'Affiliation': 'Department of Medicine, Weill Cornell Medical College, New York, New York, USA.'}, {'ForeName': 'Carma L', 'Initials': 'CL', 'LastName': 'Bylund', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Schofield', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Yuelin', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Jacobsen', 'Affiliation': 'Division of Cancer Control & Population Sciences, National Cancer Institute, Bethesda, Maryland, USA.'}, {'ForeName': 'Alan B', 'Initials': 'AB', 'LastName': 'Astrow', 'Affiliation': 'Department of Medicine, New York Methodist Hospital, Hematology and Oncology, Weill Cornell Medical College, New York, New York, USA.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Leventhal', 'Affiliation': 'Department of Psychology, Rutgers University, New Brunswick, New Jersey, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Horwitz', 'Affiliation': 'Department of Medicine, Weill Cornell Medical College, New York, New York, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kissane', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.'}]",Psycho-oncology,['10.1002/pon.5371']
3524,31219517,Safety and Efficacy of the Addition of Lapatinib to Perioperative Chemotherapy for Resectable HER2-Positive Gastroesophageal Adenocarcinoma: A Randomized Phase 2 Clinical Trial.,"Importance


Perioperative chemotherapy and surgery are a standard of care for operable gastroesophageal adenocarcinoma. Anti-HER2 therapy improves survival in patients with advanced HER2-positive disease. The safety and feasibility of adding lapatinib to perioperative chemotherapy should be assessed.
Objectives


To assess the safety of adding lapatinib to epirubicin, cisplatin, and capecitabine (ECX) chemotherapy and to establish a recommended dose regimen for a phase 3 trial.
Design, Setting, and Participants


Phase 2 randomized, open-label trial comparing standard ECX (sECX: 3 preoperative and 3 postoperative cycles of ECX with modified ECX plus lapatinib (mECX+L). This multicenter national trial was conducted in 29 centers in the United Kingdom in patients with histologically proven, HER2-positive, operable gastroesophageal adenocarcinoma. Registration for ERBB/HER2 testing took place from February 25, 2013, to April 19, 2016, and randomization took place between May 24, 2013, and April 21, 2016. Data were analyzed May 10, 2017, to May 25, 2017.
Interventions


Patients were randomized 1:1 open-label to sECX (3 preoperative and 3 postoperative cycles of 50 mg/m2 of intravenous epirubicin on day 1, 60 mg/m2 intravenous cisplatin on day 1, 1250 mg/m2 of oral capecitabine on days 1 through 21) or mECX+L (ECX plus lapatinib days 1 through 21 in each cycle and as 6 maintenance doses). The first 10 patients in the mECX+L arm were treated with 1000 mg/m2 of capecitabine and 1250 mg of lapatinib per day, after which preoperative toxic effects were reviewed according to predefined criteria to determine doses for subsequent patients.
Main Outcomes and Measures


Proportion of patients experiencing grade 3 or 4 diarrhea with mECX+L. A rate of 20% or less was considered acceptable. No formal comparison between arms was planned.
Results


Between February 2013, and April 2016, 441 patients underwent central HER2 testing and 63 (14%) were classified as HER2 positive. Forty-six patients were randomized; 44 (24 sECX, 20 mECX+L) are included in this analysis. Two of the first 10 patients in the mECX+L arm reported preoperative grade 3 diarrhea; thus, no dose increase was made. The primary endpoint of preoperative grade 3 or 4 diarrhea rates were 0 of 24 in the sECX arm (0%) and 4 of 20 in the mECX+L arm (21%). One of 24 in the sECX arm and 3 of 20 in the mECX+L arm stopped preoperative treatment early, and for 4 of 19 in the mECX+L arm, lapatinib dose was reduced. Postoperative complication rates were similar in each arm.
Conclusions and Relevance


Administration of 1250 mg of lapatinib per day in combination with ECX chemotherapy was feasible with some increase in toxic effects, which did not compromise operative management.
Trial Registration


ISRCTN.org identifier: 46020948; clinicaltrialsregister.eu identifier: 2006-000811-12.",2019,"Postoperative complication rates were similar in each arm.
","['Forty-six patients were randomized; 44 (24 sECX, 20 mECX+L', '29 centers in the United Kingdom in patients with histologically proven, HER2-positive, operable gastroesophageal adenocarcinoma', 'operable gastroesophageal adenocarcinoma', 'patients with advanced HER2-positive disease', 'Results\n\n\nBetween February 2013, and April 2016, 441 patients underwent central HER2 testing and 63 (14%) were classified as HER2 positive', 'Resectable HER2-Positive Gastroesophageal Adenocarcinoma']","['standard ECX (sECX', 'oral capecitabine', 'Anti-HER2 therapy', 'cisplatin', 'ECX with modified ECX plus lapatinib (mECX+L', 'sECX', 'Lapatinib to Perioperative Chemotherapy', 'lapatinib to epirubicin, cisplatin, and capecitabine (ECX) chemotherapy', 'mECX+L (ECX plus lapatinib', 'sECX (3 preoperative and 3 postoperative cycles of 50 mg/m2 of intravenous epirubicin', 'ECX chemotherapy', 'capecitabine and 1250 mg of lapatinib', 'lapatinib', 'mECX+L']","['preoperative grade 3 diarrhea', 'survival', 'Postoperative complication rates', 'toxic effects', 'preoperative grade 3 or 4 diarrhea rates', 'Measures\n\n\nProportion of patients experiencing grade 3 or 4 diarrhea with mECX+L. A rate', 'Safety and Efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205188', 'cui_str': 'Operable (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4517554', 'cui_str': 'One thousand two hundred and fifty'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",46.0,0.154437,"Postoperative complication rates were similar in each arm.
","[{'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Smyth', 'Affiliation': 'Department of Gastrointestinal Oncology and Lymphoma, Royal Marsden Hospital, London and Surrey, United Kingdom.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Rowley', 'Affiliation': 'Medical Research Council, Clinical Trials Unit, University College London, United Kingdom.'}, {'ForeName': 'Fay H', 'Initials': 'FH', 'LastName': 'Cafferty', 'Affiliation': 'Medical Research Council, Clinical Trials Unit, University College London, United Kingdom.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Allum', 'Affiliation': 'Department of Surgery, Royal Marsden Hospital, London and Surrey, United Kingdom.'}, {'ForeName': 'Heike I', 'Initials': 'HI', 'LastName': 'Grabsch', 'Affiliation': 'Department of Pathology, GROW School for Oncology and Developmental Biology, Maastricht University Medical Center+, Maastricht, the Netherlands.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Stenning', 'Affiliation': 'Medical Research Council, Clinical Trials Unit, University College London, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wotherspoon', 'Affiliation': 'Department of Pathology, Royal Marsden Hospital, London and Surrey, United Kingdom.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Alderson', 'Affiliation': 'Department of Surgery, Queen Elizabeth Hospital, Birmingham, United Kingdom.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Crosby', 'Affiliation': 'Velindre Cancer Centre, Cardiff, United Kingdom.'}, {'ForeName': 'Was', 'Initials': 'W', 'LastName': 'Mansoor', 'Affiliation': 'Department of Medical Oncology, Christie Hospital, Manchester, United Kingdom.'}, {'ForeName': 'Justin S', 'Initials': 'JS', 'LastName': 'Waters', 'Affiliation': 'Kent Oncology Centre, Maidstone Hospital, Kent, United Kingdom.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Neville-Webbe', 'Affiliation': 'Clatterbridge Cancer Centre, Wirral, United Kingdom.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Darby', 'Affiliation': 'Department of Oncology, Weston Park Hospital, Sheffield, United Kingdom.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Dent', 'Affiliation': 'Department of Oncology, Huddersfield Royal Infirmary, Huddersfield, United Kingdom.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Seymour', 'Affiliation': 'Leeds Institute of Cancer and Pathology, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'Heart of England NHS Trust, Birmingham, United Kingdom.'}, {'ForeName': 'Sharmila', 'Initials': 'S', 'LastName': 'Sothi', 'Affiliation': 'Department of Oncology,University Hospitals, Coventry, United Kingdom.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Blazeby', 'Affiliation': 'Bristol Centre for Surgical Research, Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Langley', 'Affiliation': 'Medical Research Council, Clinical Trials Unit, University College London, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'Department of Gastrointestinal Oncology and Lymphoma, Royal Marsden Hospital, London and Surrey, United Kingdom.'}]",JAMA oncology,['10.1001/jamaoncol.2019.1179']
3525,32147962,Nutritional training in a humanitarian context: Evidence from a cluster randomized trial.,"Behavioural change communication interventions have been shown to be effective at improving infant and young child nutrition knowledge and practices. However, evidence in humanitarian response contexts is scarce. Using data on secondary outcomes of breastfeeding, water treatment, and knowledge from a cluster randomized control trial of the Yemen Cash for Nutrition programme's impact on child nutritional status, this paper shows that the programme significantly improved knowledge and practices for poor women with young children in the pilot districts. The intervention consisted of cash transfers and monthly group nutrition education sessions led by locally recruited community health volunteers. Data are based on self-reports by participants. Estimating impacts among all 1,945 women in 190 clusters randomly assigned to treatment versus control and controlling for baseline levels and community characteristic and adjusting for noncompliance with randomization, the programme increased the probability of breastfeeding initiation within the first hour after delivery by 15.6% points (p < .05; control = 74.4% and treatment = 83.6%), the probability of exclusive breastfeeding during the first 6 months by 14.4% points (control = 13.5% and treatment = 25.3%), the probability of households treating water consumed by adults by 16.7% points (p < .01; control = 13.9% and treatment = 23.4%), and treating water consumed by children under two by 10.3% points (p < .10; control = 31.2% and treatment = 37.9%). Impacts on knowledge and breastfeeding are similar for both literate and illiterate women, and water treatment impacts are significantly larger for literate women. This study was registered at 3ie (RIDIE-STUDY-ID-5b4eff881b29a) and funded by the Nordic Trust Fund and Consultative Group on International Agricultural Research programme on Policies, Institutions, and Markets.",2020,"Impacts on knowledge and breastfeeding are similar for both literate and illiterate women, and water treatment impacts are significantly larger for literate women.","['1,945 women in 190 clusters', 'poor women with young children in the pilot districts']","['Nutritional training', 'Behavioural change communication interventions', 'cash transfers and monthly group nutrition education sessions led by locally recruited community health volunteers']","['knowledge and breastfeeding', 'probability of breastfeeding initiation', 'probability of households treating water consumed', 'knowledge and practices', 'probability of exclusive breastfeeding']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1274143', 'cui_str': 'Communication treatments and procedures'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}]",,0.0644721,"Impacts on knowledge and breastfeeding are similar for both literate and illiterate women, and water treatment impacts are significantly larger for literate women.","[{'ForeName': 'Sikandra', 'Initials': 'S', 'LastName': 'Kurdi', 'Affiliation': 'DSG, International Food Policy Research Institute.'}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Figueroa', 'Affiliation': 'National Institute of Public Health of Mexico.'}, {'ForeName': 'Hosam', 'Initials': 'H', 'LastName': 'Ibrahim', 'Affiliation': 'DSG, International Food Policy Research Institute.'}]",Maternal & child nutrition,['10.1111/mcn.12973']
3526,32062403,Comparison of gait patterns and functional measures between Charcot-Marie-Tooth disease type I and II in children to young adults.,"INTRODUCTION


Charcot-Marie-Tooth (CMT) disease is an inherited peripheral neuropathy that causes progressive distal extremity nerve degeneration and muscle atrophy which can negatively impact function, gait and quality of life. The purpose of this study was to determine if differences exist in gait patterns, clinical examination and functional measures between CMT type I (CMT1) and type II (CMT2) in childhood to young adults. It was hypothesized that individuals with CMT2 would present with greater ankle weakness, increased and/or prolonged ankle dorsiflexion in stance during gait and demonstrate greater disease severity on the CMT Pediatric Scale (CMTPedS) compared to CMT1.
METHODS


Twenty-seven individuals diagnosed with CMT1 or CMT2 underwent three-dimensional gait analysis, clinical examination and evaluation of disease severity using the CMTPedS. Subjects groups were divided based on CMT type: CMT1 (n = 20) and CMT2 (n = 7).
RESULTS


CMT2 group presented with a trend towards increased plantar flexion weakness compared to CMT1 of 61.1 ± 58.1 N to 137.9 ± 51.4 N (p < 0.012), respectively. CMT2 presented with significantly decreased dorsiflexion strength, 31.9 ± 30.9 N, compared to CMT1, 80.4 ± 37.4 N, (p < 0.0052) which negatively influenced gait patterns in CMT2. Associated gait findings demonstrated CMT2 group with significantly decreased peak ankle power generation in stance compared to CMT1 (1.46 ± 0.39 W/kg to 3.13 ± 0.98 W/kg respectively) (p < 0.0001). CMT1 was more likely to demonstrate a dorsiflexion moment in loading response than CMT2. There was a consistent trend of a higher score and therefore greater disease severity for CMT2 based on CMTPedS.
CONCLUSION


Study results suggest that at a given age, individuals with CMT2 have greater limitations in terms of gait function and disease severity than individuals with CMT1. Overall the CMT2 was shown to have greater gait limitations at the ankle during stance and swing with associated compensatory mechanisms at the knee and hip in swing.",2020,Overall the CMT2 was shown to have greater gait limitations at the ankle during stance and swing with associated compensatory mechanisms at the knee and hip in swing.,"['Twenty-seven individuals diagnosed with CMT1 or CMT2 underwent three-dimensional gait analysis, clinical examination and evaluation of disease severity using the CMTPedS. Subjects groups were divided based on CMT type', 'children to young adults', 'childhood to young adults']","['CMT1', 'CMT type I (CMT1) and type II (CMT2', 'CMT2']","['peak ankle power generation', 'gait function and disease severity', 'dorsiflexion strength', 'gait limitations', 'ankle weakness', 'plantar flexion weakness']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C0558820', 'cui_str': 'Gait Analysis'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}]","[{'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C3714552', 'cui_str': 'Weakness - general'}, {'cui': 'C0231784', 'cui_str': 'Plantar flexion, function (observable entity)'}]",27.0,0.0340518,Overall the CMT2 was shown to have greater gait limitations at the ankle during stance and swing with associated compensatory mechanisms at the knee and hip in swing.,"[{'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Pogemiller', 'Affiliation': ""Connecticut Children's, 399 Farmington Ave, Farmington, CT 06032, United States; Univesity of Hartford, 200 Bloomfield Ave, West Harford, CT 06117, United States. Electronic address: kpogemiller@connecticutchildrens.org.""}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Garibay', 'Affiliation': ""Connecticut Children's, 399 Farmington Ave, Farmington, CT 06032, United States.""}, {'ForeName': 'Kristan', 'Initials': 'K', 'LastName': 'Pierz', 'Affiliation': ""Connecticut Children's, 399 Farmington Ave, Farmington, CT 06032, United States.""}, {'ForeName': 'Gyula', 'Initials': 'G', 'LastName': 'Acsadi', 'Affiliation': ""Connecticut Children's, 399 Farmington Ave, Farmington, CT 06032, United States.""}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Õunpuu', 'Affiliation': ""Connecticut Children's, 399 Farmington Ave, Farmington, CT 06032, United States.""}]",Gait & posture,['10.1016/j.gaitpost.2020.01.027']
3527,31794928,"Concurrent cisplatin or cetuximab with radiotherapy for HPV-positive oropharyngeal cancer: Medical resource use, costs, and quality-adjusted survival from the De-ESCALaTE HPV trial.","BACKGROUND


The De-ESCALaTE HPV trial confirmed the dominance of cisplatin over cetuximab for tumour control in patients with human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma (OPSCC). Here, we present the analysis of health-related quality of life (HRQoL), resource use, and health care costs in the trial, as well as complete 2-year survival and recurrence.
MATERIALS AND METHODS


Resource use and HRQoL data were collected at intervals from the baseline to 24 months post treatment (PT). Health care costs were estimated using UK-based unit costs. Missing data were imputed. Differences in mean EQ-5D-5L utility index and adjusted cumulative quality-adjusted life years (QALYs) were compared using the Wilcoxon signed-rank test and linear regression, respectively. Mean resource usage and costs were compared through two-sample t-tests.
RESULTS


334 patients were randomised to cisplatin (n = 166) or cetuximab (n = 168). Two-year overall survival (97·5% vs 90·0%, HR: 3.268 [95% CI 1·451 to 7·359], p = 0·0251) and recurrence rates (6·4% vs 16·0%, HR: 2·67 [1·38 to 5·15]; p = 0·0024) favoured cisplatin. No significant differences in EQ-5D-5L utility scores were detected at any time point. At 24 months PT, mean difference was 0·107 QALYs in favour of cisplatin (95% CI: 0·186 to 0·029, p = 0·007) driven by the mortality difference. Health care costs were similar across all categories except the procurement cost and delivery of the systemic agent, with cetuximab significantly more expensive than cisplatin (£7779 [P < 0.001]). Consequently, total costs at 24 months PT averaged £13517 (SE: £345) per patient for cisplatin and £21064 (SE: £400) for cetuximab (mean difference £7547 [95% CI: £6512 to £8582]).
CONCLUSIONS


Cisplatin chemoradiotherapy provided more QALYs and was less costly than cetuximab bioradiotherapy, remaining standard of care for nonsurgical treatment of HPV-positive OPSCC.",2020,"At 24 months PT, mean difference was 0·107 QALYs in favour of cisplatin","['HPV-positive oropharyngeal cancer', '334 patients', 'patients with human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma (OPSCC']","['Cisplatin chemoradiotherapy', 'cetuximab', 'Concurrent cisplatin or cetuximab with radiotherapy', 'cisplatin over cetuximab', 'cisplatin']","['total costs', 'mean EQ-5D-5L utility index and adjusted cumulative quality-adjusted life years (QALYs', 'Mean resource usage and costs', 'health-related quality of life (HRQoL), resource use, and health care costs', 'EQ-5D-5L utility scores', 'overall survival', 'Health care costs', 'recurrence rates', '2-year survival and recurrence']","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C2349952', 'cui_str': 'Cancer of Oropharnyx'}, {'cui': 'C4517729', 'cui_str': '334'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0280313', 'cui_str': 'Cancer of oropharynx, squamous cell'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",334.0,0.224792,"At 24 months PT, mean difference was 0·107 QALYs in favour of cisplatin","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Jones', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Mistry', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Dalby', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Fulton-Lieuw', 'Affiliation': 'Institute of Head and Neck Studies and Education, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Anthony H', 'Initials': 'AH', 'LastName': 'Kong', 'Affiliation': 'Institute of Head and Neck Studies and Education, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Dunn', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Hisham M', 'Initials': 'HM', 'LastName': 'Mehanna', 'Affiliation': 'Institute of Head and Neck Studies and Education, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Alastair M', 'Initials': 'AM', 'LastName': 'Gray', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK. Electronic address: alastair.gray@dph.ox.ac.uk.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.10.025']
3528,31760314,"Erythrocyte-encapsulated asparaginase (eryaspase) combined with chemotherapy in second-line treatment of advanced pancreatic cancer: An open-label, randomized Phase IIb trial.","PURPOSE


This Phase IIb (NCT02195180) open-label study evaluated erythrocyte-encapsulated asparaginase (eryaspase) in combination with chemotherapy in second-line advanced pancreatic adenocarcinoma.
METHODS


Eligible patients were randomized 2:1 to either eryaspase in combination with gemcitabine or mFOLFOX6 (eryaspase arm), or to gemcitabine or mFOLFOX6 alone (control arm). Co-primary endpoints were overall survival (OS) and progression-free survival (PFS) in patients with low asparagine synthetase (ASNS) expression. Secondary endpoints included OS and PFS in the entire population.
RESULTS


141 patients were randomized (eryaspase arm, n = 95; control arm, n = 46). Median OS and PFS in patients with low ASNS expression were 6.2 months (95% CI, 5.1-8.8) in the eryaspase arm versus 4.9 months (3.1-7.1) in the control arm (HR, 0.63; 95% CI, 0.39-1.01; P = 0.056) and 2.0 months (95% CI, 1.8-3.4) in the eryaspase arm versus 1.8 months (1.4-3.8) in the control arm (HR, 0.67; 95% CI, 0.40-1.12; P = 0.127), respectively. In the entire population, median OS and PFS for the eryaspase arm versus control were 6.0 months versus 4.4 months (HR, 0.60; P = 0.008) and 2.0 months versus 1.6 months (HR, 0.56; 95% CI, 0.37-0.84; P = 0.005), respectively. The combination of eryaspase and chemotherapy was well tolerated. The most frequent Grade 3/4 adverse events in the eryaspase arm (n = 93) were gamma-glutamyltransferase increase (16 [17.2%]), neutropenia (12 [12.9%]), and physical health deterioration (12 [12.9%]).
CONCLUSION


Eryaspase in combination with chemotherapy is associated with improvements in OS and PFS, irrespective of ASNS expression in second-line advanced pancreatic adenocarcinoma. A Phase III trial is underway.",2020,"In the entire population, median OS and PFS for the eryaspase arm versus control were 6.0 months versus 4.4 months (HR, 0.60; P = 0.008) and 2.0 months versus 1.6 months (HR, 0.56; 95% CI, 0.37-0.84; P = 0.005), respectively.","['141 patients', 'Eligible patients', 'patients with low asparagine synthetase (ASNS) expression', 'advanced pancreatic cancer', 'second-line advanced pancreatic adenocarcinoma']","['eryaspase in combination with gemcitabine or mFOLFOX6 (eryaspase arm), or to gemcitabine or mFOLFOX6 alone (control arm', 'erythrocyte-encapsulated asparaginase (eryaspase) in combination with chemotherapy', 'Erythrocyte-encapsulated asparaginase (eryaspase) combined with chemotherapy']","['tolerated', 'overall survival (OS) and progression-free survival (PFS', 'gamma-glutamyltransferase increase', 'median OS and PFS', 'Median OS and PFS', 'OS and PFS in the entire population', 'physical health deterioration', 'neutropenia']","[{'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0003997', 'cui_str': 'Asparagine Synthase'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0281361', 'cui_str': 'Adenocarcinoma of pancreas'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0205223', 'cui_str': 'Encapsulated (qualifier value)'}, {'cui': 'C0003993', 'cui_str': 'ASPARAGINASE'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0151662', 'cui_str': 'Gamma-glutamyl transferase raised (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439751', 'cui_str': 'Entire (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}]",141.0,0.0757815,"In the entire population, median OS and PFS for the eryaspase arm versus control were 6.0 months versus 4.4 months (HR, 0.60; P = 0.008) and 2.0 months versus 1.6 months (HR, 0.56; 95% CI, 0.37-0.84; P = 0.005), respectively.","[{'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Hammel', 'Affiliation': 'Digestive and Medical Oncology Unit, Hôpital Beaujon, Assistance Publique - Hôpitaux de Paris, University Denis Diderot Paris VII, 92110 Clichy, France. Electronic address: pascal.hammel@aphp.fr.'}, {'ForeName': 'Portales', 'Initials': 'P', 'LastName': 'Fabienne', 'Affiliation': 'Parc Euromedecine, 208 Rue Des Apothicaires, 34070 Montpellier, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Mineur', 'Affiliation': 'Institut Sainte Catherine, Gastrointestinal and Liver Cancer Unit, Chemin de Baigne Pieds, 84000 Avignon, France.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Metges', 'Affiliation': 'CHRU de Brest - Hôpital Morvan, 2 Avenue Foch, 29609 Brest, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Andre', 'Affiliation': 'Hôpital Saint-Antoine, 184 Rue du Faubourg Saint-Antoine, 75012 Paris, and Sorbonne Universités, France.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'De La Fouchardiere', 'Affiliation': 'Medical Oncology Department, Centre Leon Berard, Lyon, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Louvet', 'Affiliation': 'Department of Medical Oncology, Institut Mutualiste Montsouris, 42 Boulevard Jourdan, 75014 Paris, France.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'El Hajbi', 'Affiliation': 'Centre Oscar Lambret, 3 Rue Frédéric Combemale, 59000 Lille, France.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Faroux', 'Affiliation': 'Les Oudairies, Hospital La Roche-Sur-Yon, Boulevard Stephane Moreau, 85000 La Roche Sur Yon, France.'}, {'ForeName': 'Rosine', 'Initials': 'R', 'LastName': 'Guimbaud', 'Affiliation': 'Institut Universitaire du Cancer, Avenue Hubert Curien, 31100 Toulouse, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tougeron', 'Affiliation': 'Gastroenterology Department and Medical Oncology Department, Poitiers University Hospital, Faculty of Medicine of Poitiers, 86000 Poitiers, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bouche', 'Affiliation': 'Service Oncologie Digestive, CHU Reims, Avenue Général Koenig, 51092 Reims Cede, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lecomte', 'Affiliation': 'Department of Hepatogastroenterology and Digestive Oncology, CHU de Tours, 37044 Tours Cedex, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Rebischung', 'Affiliation': 'Groupe Hospitalier Mutualiste de Grenoble, 8 Rue Docteur Calmette, 38100 Grenoble, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Tournigand', 'Affiliation': ""Service d'Oncologie médicale, Hôpital Henri Mondor, AP-HP, Université Paris-Est, 94010 Créteil, France.""}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Cros', 'Affiliation': 'Beaujon University Hospital, Department of Pathology-INSERM U1149, 100 Bvd Gal Lerclerc, 92110 Clichy, France.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kay', 'Affiliation': 'RK Statistics Ltd, St Giles View, Main Street, Great Longstone, Bakewell, DE45 1TZ, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Hamm', 'Affiliation': 'Cytel Inc., 675 Massachusetts Ave Cambridge, MA 02139, USA.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'ERYTECH, One Main Street, Suite 1150, Cambridge, MA 02142, USA.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Bachet', 'Affiliation': 'Sorbonne Universités, UPMC Université, Gastroenterology and Digestive Oncology Department, Pitié Salpêtrière Hospital, 75013 Paris, France.'}, {'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'El Hariry', 'Affiliation': 'ERYTECH, One Main Street, Suite 1150, Cambridge, MA 02142, USA.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.10.020']
3529,30847753,"Should We Activate Risk Perceptions in the Context of Suicide Prevention? Examining Fear Appeals, Help-Seeking Determinants, and Help-Seeking Sources Among University Employees Who Suffer from Depression.","Health promotion strategies have largely focused on activating risk perceptions for health conditions in resistant at-risk populations in order to induce behavior change. Yet, doing so remains a questionable approach when promoting help-seeking behaviors among individuals who suffer from depression because clinical symptoms can negatively affect interpretations and responses to such efforts. This study sought to test the effects and effectiveness of risk-based health messaging utilizing fear appeals on help-seeking determinants, intentions, and sources. One hundred seventeen university employees affected by symptoms of depression were recruited to participate in a lab-based experimental setting. Participants were randomly assigned to one of three message conditions that differed in strength of fear appeal (low, moderate, high) when inducing suicide risk perceptions and promoting help-seeking. Consistent with previous research, participants indicated high stigma perceptions and low intentions to seek help. Risk-based messaging strategies such as fear appeals did not have an effect on help-seeking intentions in this sample. Intentions were largely determined by positive outcome expectations and social norms, whereas efficacy perceptions were positive and not a predictor of help-seeking intentions. Participants were most likely to seek help from intimate partners and friends and least likely to utilize a help-line. Health promotion messages should contain cues that activate, rather than change, the already positive outcome expectations of seeking help when targeting at-risk populations. Future research should explore possibilities for health promotion and education among support networks of those who suffer from depression and anxiety.",2019,Risk-based messaging strategies such as fear appeals did not have an effect on help-seeking intentions in this sample.,"['University Employees', 'One hundred seventeen university employees affected by symptoms of depression were recruited to participate in a lab-based experimental setting']",['risk-based health messaging utilizing fear appeals'],[],"[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]",[],,0.0239916,Risk-based messaging strategies such as fear appeals did not have an effect on help-seeking intentions in this sample.,"[{'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Lueck', 'Affiliation': 'Department of Communication, Texas A&M University, 4234 TAMU, College Station, TX, 77843-4234, USA. jlueck@tamu.edu.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-019-0979-9']
3530,31948665,Usefulness of Postprocedural Electrophysiological Confirmation Upon Totally Thoracoscopic Ablation in Persistent Atrial Fibrillation.,"Little information is available concerning the usefulness of electrophysiological confirmation followed by totally thoracoscopic ablation. This study aimed to examine whether postprocedural electrophysiological confirmation is always necessary after totally thoracoscopic ablation (TTA) in patients with isolated persistent atrial fibrillation. Forty-five patients with isolated persistent atrial fibrillation were randomized into 2 groups those who received routine electrophysiological confirmation and additional catheter ablation after totally thoracoscopic ablation (the hybrid group [n = 22]) and those who did not (the TTA group [n = 23]). Electrophysiological study was performed 4 or 5 days after surgery. No early or late mortality occurred. In the hybrid group, 5 patients (23%, 5/22) required additional ablation due to residual potential in the left atrium. At a year postoperatively, normal sinus rhythm was observed in 89% of patients (40/45) and similar in both groups (Odds ratio 0.80, 95% confidence interval 0.32 to 1.99). During follow-up, sinus rhythm was maintained in 16 patients (70%) in the TTA group without additional catheter ablation, which was similar (p = 0.920) to the results in the hybrid group (n = 15, 68.2%). Event-free survival rate at 12 months did not differ between groups (TTA group vs hybrid group, 78% vs 77%; p = 0.633). In simple Cox regression analysis, preoperative left atrium volume index was associated with atrial arrhythmia (p = 0.030, hazards ratio 1.087, 95% confidence interval 1.01-1.18). In conclusion, thoracoscopic ablation provided good 1-year durability in patients with isolated persistent AF irrespective of postprocedural electrophysiological confirmation. Seventy-percent of the TTA group did not need additional catheter ablation.",2020,"Event-free survival rate at 12 months did not differ between groups (TTA group vs hybrid group, 78% vs 77%; p = 0.633).","['Forty-five patients with isolated persistent atrial fibrillation', 'patients with isolated persistent AF irrespective of postprocedural electrophysiological confirmation', 'Persistent Atrial Fibrillation', 'patients with isolated persistent atrial fibrillation']","['TTA group without additional catheter ablation', 'totally thoracoscopic ablation (TTA', 'Postprocedural Electrophysiological Confirmation Upon Totally Thoracoscopic Ablation', 'thoracoscopic ablation', 'routine electrophysiological confirmation and additional catheter ablation after totally thoracoscopic ablation (the hybrid group [n\u202f=\u202f22]) and those who did not (the TTA', 'TTA']","['atrial arrhythmia', 'preoperative left atrium volume index', 'need additional catheter ablation', 'normal sinus rhythm', '1-year durability', 'Event-free survival rate', 'late mortality']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}]","[{'cui': 'C1627773', 'cui_str': 'Tissue texture abnormality'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0162563', 'cui_str': 'Catheter Ablation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C0085611', 'cui_str': 'Atrial arrhythmia (disorder)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0225860', 'cui_str': 'Left Atrium'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0162563', 'cui_str': 'Catheter Ablation'}, {'cui': 'C0232202', 'cui_str': 'Normal sinus rhythm (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",45.0,0.0331554,"Event-free survival rate at 12 months did not differ between groups (TTA group vs hybrid group, 78% vs 77%; p = 0.633).","[{'ForeName': 'Min Suk', 'Initials': 'MS', 'LastName': 'Choi', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Dongguk University Ilsan Hospital, Dongguk University School of Medicine, Goyang, Gyeonggi, South Korea.'}, {'ForeName': 'Young Keun', 'Initials': 'YK', 'LastName': 'On', 'Affiliation': 'Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Dong Seop', 'Initials': 'DS', 'LastName': 'Jeong', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea. Electronic address: opheart1@gmail.com.'}, {'ForeName': 'Kyoung-Min', 'Initials': 'KM', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Seung-Jung', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'June Soo', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Keumhee C', 'Initials': 'KC', 'LastName': 'Carriere', 'Affiliation': 'Biostatistics and Clinical Epidemiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}]",The American journal of cardiology,['10.1016/j.amjcard.2019.12.046']
3531,31203240,Does a simple web-based intervention facilitate the articulation of patients' unvoiced agenda for a consultation with their diabetologists? A qualitative study.,"OBJECTIVE


To explore whether a preconsultation web-based intervention enables patients with diabetes to articulate their agenda in a consultation in the hospital outpatient clinic with their diabetologist.
METHODS AND DESIGN


A qualitative study embedded in a pragmatic pilot randomised controlled trial.
SETTING


Two city outpatient departments in England.
PARTICIPANTS


25 patients attending a follow-up consultation and 6 diabetologists.
INTERVENTION


The PACE-D, a web-based tool adapted for patients with diabetes to use before their consultation to generate an agenda of topics to discuss with their diabetologist.
DATA COLLECTION


25 participants had their consultation with their diabetologist audio-recorded: 12 in the control arm and 13 in the intervention arm; 12 of the latter also had their PACE-D intervention session and a consultation recorded. Semi-structured interviews with 6 diabetologists, and 12 patients (6 in the intervention group and 6 in the control group).
ANALYSIS


Thematic discourse analysis undertaken with patient representatives trained in qualitative data analysis techniques.
RESULTS


We identified four consultation types: diabetologist facilitated; patient identified; consultant facilitated and patient initiated and patient ignored. We also identified three critical aspects that explained the production and utilisation of the agenda form: existing consultative style; orientation to the use of the intervention and impact on the consultation. Where patients and diabetologists have a shared preference for a consultant-led or patient-led consultation, the intervention augments effective communication and shared decision making. However, where preferences diverge (eg, there is a mismatch in patients' and diabetologists' preferences and orientations), the intervention does not improve the potential for shared decision making.
CONCLUSION


A simple web-based intervention facilitates the articulation of patients' unvoiced agenda for a consultation with their diabetologist, but only when pre-existing consultation styles and orientations already favour shared decision making. More needs to be done to translate patient empowerment in the consultation setting into genuine self-efficacy.
TRIAL REGISTRATION NUMBER


ISRCTN75070242.",2019,"A simple web-based intervention facilitates the articulation of patients' unvoiced agenda for a consultation with their diabetologist, but only when pre-existing consultation styles and orientations already favour shared decision making.","['patients with diabetes', 'Two city outpatient departments in England', '25 patients attending a follow-up consultation and 6 diabetologists', '25 participants had their consultation with their diabetologist audio-recorded: 12 in the control arm and 13 in the intervention arm; 12 of the latter also had their PACE-D intervention session and a consultation recorded', 'patients with diabetes to articulate their agenda in a consultation in the hospital outpatient clinic with their diabetologist']",['preconsultation web-based intervention'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0422322', 'cui_str': 'Follow-up consultation (procedure)'}, {'cui': 'C0586863', 'cui_str': 'Diabetologist (occupation)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0029916', 'cui_str': 'Ambulatory Care Facilities, Hospital'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",[],25.0,0.0573629,"A simple web-based intervention facilitates the articulation of patients' unvoiced agenda for a consultation with their diabetologist, but only when pre-existing consultation styles and orientations already favour shared decision making.","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Frost', 'Affiliation': 'Medical School, University of Exeter, Exeter, UK.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Gibson', 'Affiliation': 'Health and Social Sciences, University of the West of England, Bristol, Bristol, UK.'}, {'ForeName': 'Obioha', 'Initials': 'O', 'LastName': 'Ukoumunne', 'Affiliation': 'NIHR CLAHRC South West Peninsula (PenCLAHRC), University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Bijay', 'Initials': 'B', 'LastName': 'Vaidya', 'Affiliation': 'Macleod Diabetes Centre, Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'Nicky', 'Initials': 'N', 'LastName': 'Britten', 'Affiliation': 'Institute for Health Service Research, University of Exeter Medical School, Exeter, UK.'}]",BMJ open,['10.1136/bmjopen-2018-026588']
3532,31065914,An Anti-hyperventilation Instruction Decreases the Drop in End-tidal CO 2  and Symptoms of Hyperventilation During Breathing at 0.1 Hz.,"Breathing at a frequency of around 0.1 Hz is widely used in basic research and in applied psychophysiology because it strongly increases fluctuations in the cardiovascular system and affects psychological functioning. Volitional control of breathing often leads to hyperventilation among untrained individuals, which may produce aversive symptoms and alter the psychological and physiological effects of the paced breathing. The present study investigated the effectiveness of a brief anti-hyperventilation instruction during paced breathing at a frequency of 0.1 Hz. Forty-six participants were randomly assigned to one of two groups: a group given an anti-hyperventilation instruction and a control group without such an instruction. The instruction asked participants to avoid excessively deep breathing and to breathe shallowly and naturally. Participants performed the breathing task for 10 min. Hyperventilation was measured by partial pressure of end-tidal CO 2  (PetCO 2 ); furthermore, symptoms of hyperventilation, feeling of air hunger, task difficulty, and affective state were measured by self-report. The results showed that paced breathing without instruction decreased PetCO 2  by 5.21 mmHg and that the use of the anti-hyperventilation instruction reduced the drop in PetCO 2  to 2.7 mmHg. Symptoms of hyperventilation were lower in the group with the anti-hyperventilation instruction. Neither the feeling of air hunger nor task difficulty were affected by the instruction. There were no significant effects of the instruction on affective state. The present study indicates that a brief anti-hyperventilation instruction may be used to decrease drop in PetCO 2  and symptoms of hyperventilation during breathing at 0.1 Hz and that the instruction is well tolerated.",2019,Neither the feeling of air hunger nor task difficulty were affected by the instruction.,"['untrained individuals', 'Forty-six participants']","['instruction asked participants to avoid excessively deep breathing and to breathe shallowly and naturally', 'anti-hyperventilation instruction and a control group without such an instruction', 'brief anti-hyperventilation instruction']","['feeling of air hunger nor task difficulty', 'Hyperventilation', 'Symptoms of hyperventilation', 'affective state', 'partial pressure of end-tidal CO 2  (PetCO 2 ); furthermore, symptoms of hyperventilation, feeling of air hunger, task difficulty, and affective state', 'End-tidal CO 2  and Symptoms of Hyperventilation']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C1321587', 'cui_str': 'Excessively deep breathing (finding)'}, {'cui': 'C0020578', 'cui_str': 'Hyperventilation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}]","[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0231848', 'cui_str': 'Air hunger (finding)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0020578', 'cui_str': 'Hyperventilation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C1272693', 'cui_str': 'Ended'}]",46.0,0.0169101,Neither the feeling of air hunger nor task difficulty were affected by the instruction.,"[{'ForeName': 'Mikołaj Tytus', 'Initials': 'MT', 'LastName': 'Szulczewski', 'Affiliation': 'Faculty of Psychology, University of Warsaw, Stawki 5/7, 00-183, Warsaw, Poland. mikolaj.szulczewski@psych.uw.edu.pl.'}]",Applied psychophysiology and biofeedback,['10.1007/s10484-019-09438-y']
3533,31606278,CYP2D6 Genotype-guided Metoprolol Therapy in Cardiac Surgery Patients: Rationale and Design of the Pharmacogenetic-guided Metoprolol Management for Postoperative Atrial Fibrillation in Cardiac Surgery (PREEMPTIVE) Pilot Study.,"OBJECTIVES


The Preemptive Pharmacogenetic-guided Metoprolol Management for Atrial Fibrillation in Cardiac Surgery (PREEMPTIVE) pilot trial aims to use existing institutional resources to develop a process for integrating CYP2D6 pharmacogenetic test results into the patient electronic health record, to develop an evidence-based clinical decision support tool to facilitate CYP2D6 genotype-guided metoprolol administration in the cardiac surgery setting, and to determine the impact of implementing this CYP2D6 genotype-guided integrated approach on the incidence of postoperative atrial fibrillation (AF), provider, and cost outcomes.
DESIGN


One-arm Bayesian adaptive design clinical trial.
SETTING


Single center, university hospital.
PARTICIPANTS


The authors will screen (including CYP2D6 genotype) up to 600 (264 ± 144 expected under the adaptive design) cardiac surgery patients, and enroll up to 200 (88 ± 48 expected) poor, intermediate, and ultrarapid CYP2D6 metabolizers over a period of 2 years at a tertiary academic center.
INTERVENTIONS


All consented and enrolled patients will receive the intervention of CYP2D6 genotype-guided metoprolol management based on CYP2D6 phenotype classified as a poor, intermediate, extensive (normal), or ultrarapid metabolizer.
MEASUREMENTS AND MAIN RESULTS


The primary outcome will be the incidence of postoperative AF. Secondary outcomes relating to rates of CYP2D6 genotype-guided prescription changes, costs, lengths of stay, and implementation metrics also will be investigated.
CONCLUSIONS


The PREEMPTIVE pilot study is the first perioperative pilot trial to provide essential information for the design of a future, large-scale trial comparing CYP2D6 genotype-guided metoprolol management with a nontailored strategy in terms of managing AF. In addition, secondary outcomes regarding implementation, clinical benefit, safety, and cost-effectiveness in patients undergoing cardiac surgery will be examined.",2020,"Secondary outcomes relating to rates of CYP2D6 genotype-guided prescription changes, costs, lengths of stay, and implementation metrics also will be investigated.
","['Cardiac Surgery Patients', 'Single center, university hospital', 'The authors will screen (including CYP2D6 genotype) up to 600 (264 ± 144 expected under the adaptive design) cardiac surgery patients, and enroll up to 200 (88 ± 48 expected) poor, intermediate, and ultrarapid CYP2D6 metabolizers over a period of 2 years at a tertiary academic center', 'patients undergoing cardiac surgery']","['CYP2D6 genotype-guided metoprolol management', 'CYP2D6 genotype-guided metoprolol management based on CYP2D6 phenotype classified as a poor, intermediate, extensive (normal), or ultrarapid metabolizer', 'CYP2D6 Genotype-guided Metoprolol Therapy', 'Metoprolol Management']","['implementation, clinical benefit, safety, and cost-effectiveness', 'rates of CYP2D6 genotype-guided prescription changes, costs, lengths of stay, and implementation metrics also will be investigated', 'incidence of postoperative AF']","[{'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C3812881', 'cui_str': 'Writer (occupation)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0057223', 'cui_str': 'CYP2D6'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}]","[{'cui': 'C0057223', 'cui_str': 'CYP2D6'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0025859', 'cui_str': 'Metoprolol'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0057223', 'cui_str': 'CYP2D6'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",,0.092156,"Secondary outcomes relating to rates of CYP2D6 genotype-guided prescription changes, costs, lengths of stay, and implementation metrics also will be investigated.
","[{'ForeName': 'Wills C', 'Initials': 'WC', 'LastName': 'Dunham', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Weinger', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA; Center for Research and Innovation in System Safety, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Slagle', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA; Center for Research and Innovation in System Safety, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Mias', 'Initials': 'M', 'LastName': 'Pretorius', 'Affiliation': 'Department of anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Ashish S', 'Initials': 'AS', 'LastName': 'Shah', 'Affiliation': 'Department of Cardiac Surgery, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Tarek S', 'Initials': 'TS', 'LastName': 'Absi', 'Affiliation': 'Department of Cardiac Surgery, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Shotwell', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA; Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Beller', 'Affiliation': 'Center for Precision Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Thomas', 'Affiliation': 'Department of Pharmaceutical Services, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Cindy L', 'Initials': 'CL', 'LastName': 'Vnencak-Jones', 'Affiliation': 'Department of Pathology, Microbiology and Immunology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Freundlich', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Wanderer', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA; Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Warren S', 'Initials': 'WS', 'LastName': 'Sandberg', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA; Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Miklos D', 'Initials': 'MD', 'LastName': 'Kertai', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA. Electronic address: miklos.kertai@vumc.org.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2019.09.003']
3534,30128163,Self Help Plus: study protocol for a cluster-randomised controlled trial of guided self-help with South Sudanese refugee women in Uganda.,"Background


Exposure to armed conflict and forced displacement constitute significant risks for mental health. Existing evidence-based psychological interventions have limitations for scaling-up in low-resource humanitarian settings. The WHO has developed a guided self-help intervention, Self Help Plus (SH+), which is brief, implemented by non-specialists, and designed to be delivered to people with and without specific mental disorders. This paper outlines the study protocol for an evaluation of the SH+ intervention in northern Uganda, with South Sudanese refugee women.
Methods


A two-arm, single-blind cluster-randomised controlled trial will be conducted in 14 villages in Rhino Camp refugee settlement, with at least 588 women experiencing psychological distress. Villages will be randomly assigned to receive either SH+ with enhanced usual care (EUC), or EUC alone. SH+ is a five-session guided self-help intervention delivered in workshops with audio-recorded materials and accompanying pictorial guide. The primary outcome is reduction in overall psychological distress over time, with 3 months post-treatment as the primary end-point. Secondary outcomes are self-defined psychosocial concerns, depression and post-traumatic stress disorder symptoms, hazardous alcohol use, feelings of anger, interethnic relations, psychological flexibility, functional impairment and subjective wellbeing. Psychological flexibility is a hypothesised mediator, and past trauma history and intervention attendance will be explored as potential moderators.
Discussion


This trial will provide important information on the effectiveness of a scalable, guided self-help intervention for improving psychological health and wellbeing among people affected by adversity.
Trial Registration


ISRCTN50148022; registered 13/03/2017.",2018,SH+ is a five-session guided self-help intervention delivered in workshops with audio-recorded materials and accompanying pictorial guide.,"['with South Sudanese refugee women in Uganda', '14 villages in Rhino Camp refugee settlement, with at least 588 women experiencing psychological distress', 'mental health', 'northern Uganda, with South Sudanese refugee women']","['SH', 'SH+ intervention', 'Plus (SH', 'SH+ with enhanced usual care (EUC), or EUC alone', 'guided self-help']","['self-defined psychosocial concerns, depression and post-traumatic stress disorder symptoms, hazardous alcohol use, feelings of anger, interethnic relations, psychological flexibility, functional impairment and subjective wellbeing', 'overall psychological distress']","[{'cui': 'C0241297', 'cui_str': 'Sudanese (ethnic group)'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0012054', 'cui_str': ""N',O'-Dibutyryl-cAMP""}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",588.0,0.0945444,SH+ is a five-session guided self-help intervention delivered in workshops with audio-recorded materials and accompanying pictorial guide.,"[{'ForeName': 'F L', 'Initials': 'FL', 'LastName': 'Brown', 'Affiliation': 'War Child Holland, Amsterdam, The Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Carswell', 'Affiliation': 'Department of Mental Health and Substance Abuse, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Augustinavicius', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Adaku', 'Affiliation': 'HealthRight International, New York, NY.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Leku', 'Affiliation': 'HealthRight International, New York, NY.'}, {'ForeName': 'R G', 'Initials': 'RG', 'LastName': 'White', 'Affiliation': 'Institute of Psychology Health and Society, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ventevogel', 'Affiliation': 'Public Health Section, United Nations High Commissioner for Refugees, Geneva, Switzerland.'}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Kogan', 'Affiliation': 'School of Psychology, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'García-Moreno', 'Affiliation': 'Department of Reproductive Health & Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Bryant', 'Affiliation': 'University of New South Wales, Sydney, Australia.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Musci', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van Ommeren', 'Affiliation': 'Department of Mental Health and Substance Abuse, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'W A', 'Initials': 'WA', 'LastName': 'Tol', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}]","Global mental health (Cambridge, England)",['10.1017/gmh.2018.17']
3535,31622733,Three-Year Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC-Update from PACIFIC.,"INTRODUCTION


In the phase 3 PACIFIC study of patients with unresectable stage III NSCLC without progression after chemoradiotherapy, durvalumab demonstrated significant improvements versus placebo in the primary end points of progression-free survival (hazard ratio [HR] = 0.52, 95% confidence interval [CI]: 0.42-65, p < 0.0001) and overall survival (OS) (HR = 0.68, 95% CI: 0.53-0.87, p = 0.00251), with manageable safety and no detrimental effect on patient-reported outcomes. Here, we report 3-year OS rates for all patients randomized in the PACIFIC study.
METHODS


Patients, stratified by age, sex, and smoking history, were randomized (2:1) to receive durvalumab, 10 mg/kg intravenously every 2 weeks, or placebo for up to 12 months. OS was analyzed by using a stratified log-rank test in the intention-to-treat population. Medians and rates at 12, 24, and 36 months were estimated by the Kaplan-Meier method.
RESULTS


As of January 31, 2019, 48.2% of patients had died (44.1% and 56.5% in the durvalumab and placebo groups, respectively). The median duration of follow-up was 33.3 months. The updated OS remained consistent with that previously reported (stratified HR = 0.69 [95% CI: 0.55-0.86]); the median OS was not reached with durvalumab but was 29.1 months with placebo. The 12-, 24- and 36-month OS rates with durvalumab and placebo were 83.1% versus 74.6%, 66.3% versus 55.3%, and 57.0% versus 43.5%, respectively. All secondary outcomes examined showed improvements consistent with previous analyses.
CONCLUSIONS


Updated OS data from PACIFIC, including 3-year survival rates, demonstrate the long-term clinical benefit with durvalumab after chemoradiotherapy and further establish the PACIFIC regimen as the standard of care in this population.",2020,"The 12-, 24- and 36-month OS rates with durvalumab and placebo were 83.1% versus 74.6%, 66.3% versus 55.3%, and 57.0% versus 43.5%, respectively.","['patients with unresectable, Stage III NSCLC without progression after chemoradiotherapy (CRT', 'Stage III NSCLC - Update from PACIFIC', 'Patients, stratified by age, sex and smoking history']","['placebo', 'durvalumab 10 mg/kg intravenously every 2 weeks or placebo', 'durvalumab and placebo', 'durvalumab after chemoradiotherapy']","['3-year OS rates', 'died', 'progression-free survival', 'median OS', 'overall survival', '3-year survival rates', 'Median duration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",,0.557291,"The 12-, 24- and 36-month OS rates with durvalumab and placebo were 83.1% versus 74.6%, 66.3% versus 55.3%, and 57.0% versus 43.5%, respectively.","[{'ForeName': 'Jhanelle E', 'Initials': 'JE', 'LastName': 'Gray', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida. Electronic address: Jhanelle.Gray@moffitt.org.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Villegas', 'Affiliation': 'Cancer Specialists of North Florida, Jacksonville, Florida.'}, {'ForeName': 'Davey', 'Initials': 'D', 'LastName': 'Daniel', 'Affiliation': 'Tennessee Oncology, Chattanooga, Tennessee; Sarah Cannon Research Institute, Nashville, Tennessee.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Vicente', 'Affiliation': 'University Hospital Virgen Macarena, Seville, Spain.'}, {'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Murakami', 'Affiliation': 'Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Hui', 'Affiliation': 'Westmead Hospital, Sydney, New South Wales, Australia; University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Takayasu', 'Initials': 'T', 'LastName': 'Kurata', 'Affiliation': 'Kansai Medical University Hospital, Hirakata, Japan.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Chiappori', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.'}, {'ForeName': 'Ki Hyeong', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Republic of Korea.'}, {'ForeName': 'Byoung Chul', 'Initials': 'BC', 'LastName': 'Cho', 'Affiliation': 'Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Planchard', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Paz-Ares', 'Affiliation': 'University Hospital October 12, CiberOnc, Complutense University of Madrid, Madrid, Spain; National Cancer Research Center, Madrid, Spain.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Faivre-Finn', 'Affiliation': 'The University of Manchester and The Christie National Health Service Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Johan F', 'Initials': 'JF', 'LastName': 'Vansteenkiste', 'Affiliation': 'University Hospitals KU Leuven, Leuven, Belgium.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Spigel', 'Affiliation': 'Sarah Cannon Research Institute, Nashville, Tennessee.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Wadsworth', 'Affiliation': 'AstraZeneca, Alderley Park, United Kingdom.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Taboada', 'Affiliation': 'AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Phillip A', 'Initials': 'PA', 'LastName': 'Dennis', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Özgüroğlu', 'Affiliation': 'Istanbul University-Cerrahpasa, Cerrahpasa School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Antonia', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2019.10.002']
3536,31034045,Effect of Gastric Residual Evaluation on Enteral Intake in Extremely Preterm Infants: A Randomized Clinical Trial.,"Importance


Evaluating prefeed gastric residuals is considered routine care but has little supporting evidence.
Objective


To determine the effect of omitting prefeed gastric residual evaluation on nutritional outcomes in extremely preterm infants.
Design, Setting, and Participants


This single-center randomized clinical trial compared the omission of gastric residual evaluation with prefeed gastric residual evaluation. Infants were recruited from a level 4 neonatal intensive care unit and were enrolled from October 17, 2013, to October 8, 2016, and then followed up for 6 weeks after birth. Eligible participants were infants born at 32 or fewer weeks' gestation with a birth weight of 1250 g or less; they were enrolled within 72 hours after birth and within 24 hours after feeding initiation. All participants (N = 143) were included in the modified intent-to-treat analysis, which was conducted from March to July 2018.
Interventions


The residual group underwent prefeed gastric residual evaluation; the no residual group did not. Feeding decisions were made according to nutritional guidelines, and infants received only human milk.
Main Outcomes and Measures


The primary outcome was weekly enteral nutrition intake in mL/kg for 6 weeks after birth.
Results


Of 143 infants, 74 (51.7%) were randomized to undergo gastric residual evaluation (residual group) and 69 (48.3%) to omitted gastric residual evaluation (no residual group). The residual group comprised an even number of male and female infants (37 [50.0%]) with a mean (SD) gestational age of 27.1 (2.4) weeks and a mean (SD) birth weight of 888.8 (206.6) grams, whereas the no residual group had more male infants (36 [52.17%]), a mean (SD) gestational age of 27 (1.2) weeks, and a mean (SD) birth weight of 915.2 (180) grams. The no residual group had feedings that advanced more quickly compared with the residual group (mean weekly increase, 20.7 mL/kg/d vs 17.9 mL/kg/d; P = .02) and consumed more feedings at weeks 5 (137.2 [95% CI, 128.6-145.8]; P = .03) and 6 (141.6 [95% CI, 133.2-150.0]; P = .03). Among the secondary outcomes, the no residual group had higher mean estimated log weights (7.01 [95% CI, 6.99-7.02] vs 6.98 [95% CI, 6.97-7.00]; P = .03), had fewer episodes of abdominal distention (0.59 [95% CI, 0.34-1.01] vs 1.79 [95% CI, 1.27-2.53]; P = .001), and were discharged 8 days earlier (4.21 [95% CI, 4.14-4.28] vs 4.28 [95% CI, 4.19-4.36]; P = .01). Odds for necrotizing enterocolitis (0.058 [95% CI, 0.018-0.190] vs 0.026 [95% CI, 0.006-0.109]), death (0.004 [95% CI, 0.0003-0.046] vs 0.012 [95% CI, 0.001-0.131]), late-onset sepsis (0.970 [95% CI, 0.67-1.40] vs 1.38 [95% CI, 0.97-1.94]), and ventilator-associated pneumonia (0.084 [95% CI, 0.033-0.214] vs 0.056 [95% CI, 0.019-0.168]) were similar between groups.
Conclusions and Relevance


Among extremely preterm infants, the omission of gastric residual evaluation increased the delivery of enteral nutrition as well as improved weight gain and led to earlier hospital discharge; these results may translate into evidence-based practice.
Trial Registration


ClinicalTrials.gov identifier: NCT01863043.",2019,"Odds for necrotizing enterocolitis (0.58 [95% CI, 0.18-0.19] vs 0.026 [95% CI, 0.006-0.109]), death (0.004 [95% CI, 0.0003-0.046] vs 0.012 [95% CI, 0.001-0.131]), late-onset sepsis (0.970 [95% CI, 0.67-1.40] vs 1.38 [95% CI, 0.97-1.94]), and ventilator-associated pneumonia (0.084 [95% CI, 0.033-0.214] vs 0.056 [95% CI, 0.019-0.168]) were similar between groups.
","['Extremely Preterm Infants', 'male and female infants (37 [50.0%]) with a mean (SD) gestational age of 27.1 (2.4) weeks and a mean (SD) birth weight of 888.8 (206.6) grams, whereas the no residual group had more male infants (36 [52.17%]), a mean (SD) gestational age of 27 (1.2) weeks, and a mean (SD) birth weight of 915.2 (180) grams', 'All participants (N\u2009=\u2009143) were included in the modified intent-to-treat analysis, which was conducted from March to July 2018', 'Infants were recruited from a level 4 neonatal intensive care unit and were enrolled from October 17, 2013, to October 8, 2016, and then followed up for 6 weeks after birth', ""Eligible participants were infants born at 32 or fewer weeks' gestation with a birth weight of 1250 g or less; they were enrolled within 72 hours after birth and within 24 hours after feeding initiation"", 'extremely preterm infants', '143 infants, 74 (51.7%) were randomized to undergo gastric residual evaluation (residual group) and 69 (48.3%) to omitted gastric residual evaluation (no residual group']","['Gastric Residual Evaluation', 'omitting prefeed gastric residual evaluation']","['necrotizing enterocolitis', 'Enteral Intake', 'death', 'weekly enteral nutrition intake in mL/kg for 6 weeks after birth', 'late-onset sepsis', 'ventilator-associated pneumonia', 'weight gain', 'episodes of abdominal distention', 'nutritional outcomes', 'mean estimated log weights']","[{'cui': 'C3494262', 'cui_str': 'Extremely Preterm Infants'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0456950', 'cui_str': 'Level 4 (qualifier value)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C4517554', 'cui_str': 'One thousand two hundred and fifty'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C1292423', 'cui_str': '72 hours (qualifier value)'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C3665864', 'cui_str': 'Gastric residuals'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C3665864', 'cui_str': 'Gastric residuals'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0520459', 'cui_str': 'Necrotizing Enterocolitis'}, {'cui': 'C1304890', 'cui_str': 'Enteral (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",,0.376587,"Odds for necrotizing enterocolitis (0.58 [95% CI, 0.18-0.19] vs 0.026 [95% CI, 0.006-0.109]), death (0.004 [95% CI, 0.0003-0.046] vs 0.012 [95% CI, 0.001-0.131]), late-onset sepsis (0.970 [95% CI, 0.67-1.40] vs 1.38 [95% CI, 0.97-1.94]), and ventilator-associated pneumonia (0.084 [95% CI, 0.033-0.214] vs 0.056 [95% CI, 0.019-0.168]) were similar between groups.
","[{'ForeName': 'Leslie A', 'Initials': 'LA', 'LastName': 'Parker', 'Affiliation': 'College of Nursing, University of Florida, Gainesville.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weaver', 'Affiliation': 'College of Nursing, University of Florida, Gainesville.'}, {'ForeName': 'Roberto J', 'Initials': 'RJ', 'LastName': 'Murgas Torrazza', 'Affiliation': 'Sistema Nacional de Investigacion de Panama, Secretaria Nacional de Ciencia Tecnologia e Innovacion, Punta Pacifica, Panama.'}, {'ForeName': 'Jonathon', 'Initials': 'J', 'LastName': 'Shuster', 'Affiliation': 'Department of Health Outcomes and Policy, University of Florida, Gainesville.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Pediatrics, University of Florida, Gainesville.'}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'Krueger', 'Affiliation': 'College of Nursing, University of Florida, Gainesville.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Neu', 'Affiliation': 'Department of Pediatrics, University of Florida, Gainesville.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2019.0800']
3537,30964381,Mucociliary Clearance in Former Tobacco Smokers with Both Chronic Obstructive Pulmonary Disease and Chronic Bronchitis and the Effect of Roflumilast.,"Background:  Little is known of the repeatability and reliability of mucociliary clearance (MCC) in former tobacco smokers who have both chronic obstructive pulmonary disease (COPD) and chronic bronchitis (CB). Less is known of the effect of roflumilast, a selective inhibitor of PDE4, on MCC in these patients.  Methods:  Former tobacco smokers with COPD and CB were treated for 4 weeks with either roflumilast, or placebo, in a randomized, crossover trial. The following were measured on two baseline and two posttreatment visits: MCC values through 90 minutes, following inhalation of  99m technetium sulfur colloid and gamma camera imaging; outer:inner (O:I) deposition ratio; forced expiratory volume in 1 second (FEV 1 ); and symptom scores. Comparisons included: MCC measures through 30 minutes (MCC30), 60 minutes (MCC60), and 90 minutes (MCC90) on the two baseline visits ( n  = 9) and mean change [(roflumilast - baseline)-(placebo - baseline)] for MCC30, MCC60, MCC90, and FEV 1  ( n  = 8). Associations between MCC measurements, FEV 1  and O:I ratio with symptom scores were also examined.  Results:  Pearson correlation tests indicated good repeatability for baseline measures of MCC30, MCC60, and MCC90 and intraclass correlation coefficients indicated good reliability. Only FEV 1  (percent predicted) improved significantly following roflumilast treatment. There were no statistically significant correlations between MCC measures and symptom scores. Lower FEV 1  values were significantly associated with increased shortness of breath (dyspnea), and lower O:I ratios (more inner region deposition) were significantly associated with increased cough and sputum.  Conclusions:  Measurements of MCC30, MCC60, and MCC90 are repeatable and reliable in former tobacco smokers with both COPD and CB. One month of treatment with roflumilast did not improve MCC in this limited study. Airway narrowing in the larger, central airways of these subjects could lead to decreased FEV 1 , increased inner region deposition of the radiolabeled particles, and the associated increase in symptoms of dyspnea, cough, and sputum.",2019,"Lower FEV 1  values were significantly associated with increased shortness of breath (dyspnea), and lower O:I ratios (more inner region deposition) were significantly associated with increased cough and sputum.
","['Former Tobacco Smokers with Both Chronic Obstructive Pulmonary Disease and Chronic Bronchitis', 'Former tobacco smokers with COPD and CB', 'former tobacco smokers who have both chronic obstructive pulmonary disease (COPD) and chronic bronchitis (CB']","['Roflumilast', 'roflumilast', 'roflumilast, or placebo', 'mucociliary clearance (MCC']","['cough and sputum', 'technetium sulfur colloid and gamma camera imaging; outer:inner (O:I) deposition ratio; forced expiratory volume in 1 second (FEV 1 ); and symptom scores', 'shortness of breath (dyspnea), and lower O:I ratios (more inner region deposition', 'Mucociliary Clearance', 'MCC measures through 30 minutes (MCC30), 60 minutes (MCC60), and 90 minutes (MCC90) on the two baseline visits (n\u2009=\u20099) and mean change [(roflumilast - baseline)-(placebo - baseline)] for MCC30, MCC60, MCC90, and FEV 1  (n\u2009=\u20098', 'symptoms of dyspnea, cough, and sputum', 'MCC measurements, FEV 1  and O:I ratio with symptom scores', 'MCC', 'MCC measures and symptom scores']","[{'cui': 'C4505217', 'cui_str': 'Smokers, Tobacco'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0008677', 'cui_str': 'Bronchitis, Chronic'}]","[{'cui': 'C0965618', 'cui_str': 'Roflumilast'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026687', 'cui_str': 'Mucociliary Transport'}]","[{'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0039419', 'cui_str': 'technetium (99mTc) sulfur colloid'}, {'cui': 'C0034606', 'cui_str': 'Gamma Camera Imaging'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0333562', 'cui_str': 'Deposition (morphologic abnormality)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0026687', 'cui_str': 'Mucociliary Transport'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes (qualifier value)'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0965618', 'cui_str': 'Roflumilast'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",,0.114997,"Lower FEV 1  values were significantly associated with increased shortness of breath (dyspnea), and lower O:I ratios (more inner region deposition) were significantly associated with increased cough and sputum.
","[{'ForeName': 'Beth L', 'Initials': 'BL', 'LastName': 'Laube', 'Affiliation': '1Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Carson', 'Affiliation': '2Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Sharpless', 'Affiliation': '1Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Paulin', 'Affiliation': '3Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Nadia N', 'Initials': 'NN', 'LastName': 'Hansel', 'Affiliation': '1Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}]",Journal of aerosol medicine and pulmonary drug delivery,['10.1089/jamp.2018.1459']
3538,31888565,The impact of depression and anxiety treatment on biological aging and metabolic stress: study protocol of the MOod treatment with antidepressants or running (MOTAR) study.,"BACKGROUND


Depressive and anxiety disorders have shown to be associated to premature or advanced biological aging and consequently to adversely impact somatic health. Treatments with antidepressant medication or running therapy are both found to be effective for many but not all patients with mood and anxiety disorders. These interventions may, however, work through different pathophysiological mechanisms and could differ in their impact on biological aging and somatic health. This study protocol describes the design of an unique intervention study that examines whether both treatments are similarly effective in reducing or reversing biological aging (primary outcome), psychiatric status, metabolic stress and neurobiological indicators (secondary outcomes).
METHODS


The MOod Treatment with Antidepressants or Running (MOTAR) study will recruit a total of 160 patients with a current major depressive and/or anxiety disorder in a mental health care setting. Patients will receive a 16-week treatment with either antidepressant medication or running therapy (3 times/week). Patients will undergo the treatment of their preference and a subsample will be randomized (1:1) to overcome preference bias. An additional no-disease-no-treatment group of 60 healthy controls without lifetime psychopathology, will be included as comparison group for primary and secondary outcomes at baseline. Assessments are done at week 0 for patients and controls, and at week 16 and week 52 for patients only, including written questionnaires, a psychiatric and medical examination, blood, urine and saliva collection and a cycle ergometer test, to gather information about biological aging (telomere length and telomerase activity), mental health (depression and anxiety disorder characteristics), general fitness, metabolic stress-related biomarkers (inflammation, metabolic syndrome, cortisol) and genetic determinants. In addition, neurobiological alterations in brain processes will be assessed using structural and functional Magnetic Resonance Imaging (MRI) in a subsample of at least 25 patients per treatment arm and in all controls.
DISCUSSION


This intervention study aims to provide a better understanding of the impact of antidepressant medication and running therapy on biological aging, metabolic stress and neurobiological indicators in patients with depressive and anxiety disorders in order to guide a more personalized medicine treatment.
TRIAL REGISTRATION


Trialregister.nl Number of identification: NTR3460, May 2012.",2019,Treatments with antidepressant medication or running therapy are both found to be effective for many but not all patients with mood and anxiety disorders.,"['160 patients with a current major depressive and/or anxiety disorder in a mental health care setting', 'patients with mood and anxiety disorders', '60 healthy controls without lifetime psychopathology', 'patients with depressive and anxiety disorders in order to guide a more personalized medicine treatment']","['antidepressant medication or running therapy', 'Antidepressants or Running (MOTAR', 'antidepressant medication and running therapy', 'MOod treatment with antidepressants or running (MOTAR']","['biological aging (telomere length and telomerase activity), mental health (depression and anxiety disorder characteristics), general fitness, metabolic stress-related biomarkers (inflammation, metabolic syndrome, cortisol) and genetic determinants', 'biological aging, metabolic stress and neurobiological indicators', 'reversing biological aging (primary outcome), psychiatric status, metabolic stress and neurobiological indicators (secondary outcomes']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C2718059', 'cui_str': 'Personalized Medicine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]","[{'cui': 'C0085759', 'cui_str': 'Biological Aging'}, {'cui': 'C0085187'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0087071', 'cui_str': 'Telomerase Reverse Transcriptase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C2350024', 'cui_str': 'Metabolic Stress'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",60.0,0.0499851,Treatments with antidepressant medication or running therapy are both found to be effective for many but not all patients with mood and anxiety disorders.,"[{'ForeName': 'Bianca A', 'Initials': 'BA', 'LastName': 'Lever-van Milligen', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit, Psychiatry, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands. b.lever@ggzingeest.nl.'}, {'ForeName': 'Josine E', 'Initials': 'JE', 'LastName': 'Verhoeven', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit, Psychiatry, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Lianne', 'Initials': 'L', 'LastName': 'Schmaal', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit, Psychiatry, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'van Velzen', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit, Psychiatry, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Dóra', 'Initials': 'D', 'LastName': 'Révész', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit, Psychiatry, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Catherine N', 'Initials': 'CN', 'LastName': 'Black', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit, Psychiatry, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Laura K M', 'Initials': 'LKM', 'LastName': 'Han', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit, Psychiatry, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Melany', 'Initials': 'M', 'LastName': 'Horsfall', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit, Psychiatry, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Neeltje M', 'Initials': 'NM', 'LastName': 'Batelaan', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit, Psychiatry, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Anton J L M', 'Initials': 'AJLM', 'LastName': 'van Balkom', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit, Psychiatry, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Digna J F', 'Initials': 'DJF', 'LastName': 'van Schaik', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit, Psychiatry, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'van Oppen', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit, Psychiatry, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Brenda W J H', 'Initials': 'BWJH', 'LastName': 'Penninx', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit, Psychiatry, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}]",BMC psychiatry,['10.1186/s12888-019-2404-0']
3539,31157598,Behavioral intention to perform risk compensation behaviors after receiving HPV vaccination among men who have sex with men in China.,"Men who have sex with men (MSM) are recommended to take up human papillomavirus (HPV) vaccination. There are concerns that MSM would increase sexual risk behaviors after taking up HPV vaccination, a phenomenon known as risk compensation. This study investigated the prevalence of and factors associated with behavioral intention to reduce the frequency of condom use with men after receiving the HPV vaccination. The study was based on the baseline sample of an ongoing randomized controlled trial promoting HPV vaccination among MSM in Hong Kong. Hong Kong Chinese-speaking MSM who have never vaccinated against HPV were recruited from multiple sources. A total of 624 participants completed the baseline survey during July to December 2017. The prevalence of behavior intention to reduce the frequency of condom use with regular and non-regular male sex partners after receiving HPV vaccination was 6.9% and 4.0%; 8.0% of them intended to reduce condom use with either type of male partners after receiving the HPV vaccination. Adjusting for significant background variables (education level and condomless anal intercourse with men in the last six months), two constructs of the pre-intentional phase of Health Action Process Approach model were significantly associated with the dependent variable in the expected direction. They were (1) positive outcome expectancies of condomless anal intercourse after receiving HPV vaccination (adjusted odds ratios [AOR]: 1.29, 95% confidence interval [CI]: 1.12, 1.48,  p  < 0.001) and (2) perceived self-efficacy of consistent condom use after receiving HPV vaccination (AOR: 0.83, 95% CI: 0.70, 0.92,  p  = 0.001). Risk compensation may not be a major concern when promoting HPV vaccination among MSM. The results should be assuring health-care providers and policymakers.",2019,The prevalence of behavior intention to reduce the frequency of condom use with regular and non-regular male sex partners after receiving HPV vaccination was 6.9% and 4.0%; 8.0% of them intended to reduce condom use with either type of male partners after receiving the HPV vaccination.,"['624 participants completed the baseline survey during July to December 2017', 'men who have sex with men in China', 'Hong Kong Chinese-speaking MSM who have never vaccinated against HPV', 'Men who have sex with men (MSM']","['MSM', 'Behavioral intention', 'HPV vaccination among MSM', 'HPV vaccination']","['sexual risk behaviors', 'self-efficacy', 'positive outcome expectancies of condomless anal intercourse']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0556628', 'cui_str': 'Anal penetration (finding)'}]",624.0,0.140025,The prevalence of behavior intention to reduce the frequency of condom use with regular and non-regular male sex partners after receiving HPV vaccination was 6.9% and 4.0%; 8.0% of them intended to reduce condom use with either type of male partners after receiving the HPV vaccination.,"[{'ForeName': 'Terence', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'a JC School of Public Health and Primary Care, Faculty of Medicine, The Chinese University of Hong Kong , Hong Kong , China.'}, {'ForeName': 'Shuyu', 'Initials': 'S', 'LastName': 'Qu', 'Affiliation': 'b School of Public Health, Shanghai University of Traditional Chinese Medicine , Shanghai , China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': 'a JC School of Public Health and Primary Care, Faculty of Medicine, The Chinese University of Hong Kong , Hong Kong , China.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Ip', 'Affiliation': 'a JC School of Public Health and Primary Care, Faculty of Medicine, The Chinese University of Hong Kong , Hong Kong , China.'}, {'ForeName': 'Zixin', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'a JC School of Public Health and Primary Care, Faculty of Medicine, The Chinese University of Hong Kong , Hong Kong , China.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2019.1622975']
3540,30979409,Usefulness of a Positive Psychology-Motivational Interviewing Intervention to Promote Positive Affect and Physical Activity After an Acute Coronary Syndrome.,"Most patients are not able to achieve recommended levels of physical activity following an acute coronary syndrome (ACS). Existing interventions to promote activity have not focused on promoting psychological well-being, which is independently linked to superior cardiac health. To address this gap, we developed and tested a combined positive psychology-motivational interviewing (PP-MI) intervention in post-ACS patients to assess its feasibility and explore potential benefits in an initial randomized trial. We compared a 12-week, phone-delivered, PP-MI intervention to an attention-matched, MI-based health education control condition among 47 post-ACS patients with low baseline health behavior adherence. Feasibility/acceptability were assessed through rates of session completion and participant session ratings; we also explored between-group differences in positive affect, other self-reported outcomes, and accelerometer-measured physical activity, through mixed effects regression models, at 12 and 24 weeks. PP-MI participants completed a mean of 10.0 (standard deviation 2.2) sessions (84%), and mean participant ratings of sessions' ease/utility were >8/10, above a priori thresholds for success. Compared with the control condition, PP-MI was associated with greater improvements in positive affect at 12 and 24 weeks (12 weeks: estimated mean difference [EMD] = 3.90 [SE = 1.95], p = 0.045, effect size [ES] = 0.56; 24 weeks: EMD = 7.34 [SE = 2.16], p <0.001, ES = 1.12). PP-MI was also associated with more daily steps at 12 weeks (EMD = 1842.1 steps/day [SE = 849.8], p = 0.030, ES = 0.76) and greater moderate-vigorous activity at 24 weeks (EMD = 15.1 minutes/day [SE = 6.8], p = 0.026, ES = 0.81). In conclusion, PP-MI was feasible in post-ACS patients and showed promising effects on well-being and physical activity; additional studies are needed to confirm these findings.",2019,"Compared with the control condition, PP-MI was associated with greater improvements in positive affect at 12 and 24 weeks (12 weeks: estimated mean difference [EMD] = 3.90 [SE = 1.95], p = 0.045, effect size [ES] = 0.56; 24 weeks: EMD = 7.34 [SE = 2.16], p <0.001, ES = 1.12).",['among 47 post-ACS patients with low baseline health behavior adherence'],"['Positive Psychology-Motivational Interviewing Intervention', 'combined positive psychology-motivational interviewing (PP-MI) intervention', 'phone-delivered, PP-MI intervention to an attention-matched, MI-based health education control condition']","['Physical Activity', 'rates of session completion and participant session ratings', 'moderate-vigorous activity', 'Feasibility/acceptability', 'PP-MI']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0018687'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018701'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.0548853,"Compared with the control condition, PP-MI was associated with greater improvements in positive affect at 12 and 24 weeks (12 weeks: estimated mean difference [EMD] = 3.90 [SE = 1.95], p = 0.045, effect size [ES] = 0.56; 24 weeks: EMD = 7.34 [SE = 2.16], p <0.001, ES = 1.12).","[{'ForeName': 'Jeff C', 'Initials': 'JC', 'LastName': 'Huffman', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts; Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts. Electronic address: jhuffman@partners.org.'}, {'ForeName': 'Emily H', 'Initials': 'EH', 'LastName': 'Feig', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts; Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Millstein', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts; Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Freedman', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Healy', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts; Department of Neurology, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Wei-Jean', 'Initials': 'WJ', 'LastName': 'Chung', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts; Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Hermioni L', 'Initials': 'HL', 'LastName': 'Amonoo', 'Affiliation': ""Harvard Medical School, Boston, Massachusetts; Department of Psychiatry, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Malloy', 'Affiliation': 'Benson Henry Institute for Mind-Body Medicine, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Slawsby', 'Affiliation': 'Benson Henry Institute for Mind-Body Medicine, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Januzzi', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts; Division of Cardiology, Department of Medicine, Massachusetts General Hospital and Cardiometabolic Trials, Baim Institute for Clinical Research, Boston, Massachusetts.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Celano', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts; Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}]",The American journal of cardiology,['10.1016/j.amjcard.2019.03.023']
3541,29998740,The impact of implementation support on the use of a social engagement intervention for children with autism in public schools.,"Several interventions have demonstrated efficacy in improving social outcomes for children with autism; however, few have been successfully implemented in schools. This study compared two implementation strategies to improve the use of a social engagement intervention for children with autism in public schools. In total, 31 children with autism in grades K-5 and 28 school personnel participated in a randomized controlled trial. Schools were randomized to (1) training in Remaking Recess, a social engagement intervention, or (2) training in Remaking Recess with implementation support. Linear regression with random effects was used to test the intervention effects on implementation fidelity and social outcomes (peer engagement, social network inclusion, and friendship nominations). In both groups, implementation fidelity improved after training but remained low. Children in the Remaking Recess with implementation support condition had significantly higher social network inclusion and received more friendship nominations than children in the Remaking Recess-only condition (p = 0.03). Children in both groups experienced reduced solitary engagement (p < 0.001) and increased joint engagement (p < 0.001). The results suggest that implementation supports may have an effect on outcomes above and beyond the intervention, and that further research is needed into the active intervention mechanisms.",2019,Children in both groups experienced reduced solitary engagement (p < 0.001) and increased joint engagement (p < 0.001).,"['children with autism in public schools', 'children with autism', '31 children with autism in grades K-5 and 28 school personnel']","['social engagement intervention', 'training in Remaking Recess, a social engagement intervention, or (2) training in Remaking Recess with implementation support']","['implementation fidelity and social outcomes (peer engagement, social network inclusion, and friendship nominations', 'implementation fidelity', 'joint engagement', 'reduced solitary engagement', 'friendship nominations', 'social network inclusion']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0557800', 'cui_str': 'Public school (environment)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0108311', 'cui_str': 'polysaccharide K5, E coli'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0178647', 'cui_str': 'Friendship'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]",31.0,0.0562731,Children in both groups experienced reduced solitary engagement (p < 0.001) and increased joint engagement (p < 0.001).,"[{'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Locke', 'Affiliation': '1 University of Washington, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Shih', 'Affiliation': '2 Loma Linda University, USA.'}, {'ForeName': 'Christina D', 'Initials': 'CD', 'LastName': 'Kang-Yi', 'Affiliation': '3 University of Pennsylvania, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Caramanico', 'Affiliation': '3 University of Pennsylvania, USA.'}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Shingledecker', 'Affiliation': '3 University of Pennsylvania, USA.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Gibson', 'Affiliation': '3 University of Pennsylvania, USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Frederick', 'Affiliation': '1 University of Washington, USA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Mandell', 'Affiliation': '3 University of Pennsylvania, USA.'}]",Autism : the international journal of research and practice,['10.1177/1362361318787802']
3542,31891312,To chase or not to chase: A study on the role of mentalization and alcohol consumption in chasing behavior.,"BACKGROUND AND AIMS


Chasing is a behavioral marker and a diagnostic criterion for gambling disorder. Although chasing has been recognized to play a central role in gambling disorder, research on this topic is relatively scarce. This study investigated the association between chasing, alcohol consumption, and mentalization among habitual gamblers.
METHOD


A total of 132 adults took part in the study. Participants were administered the South Oaks Gambling Screen, the Alcohol Use Disorders Identification Test, the Reflective Functioning Questionnaire, and a laboratory task assessing chasing behavior. Participants were randomly assigned to three experimental conditions (Control, Loss, and Win). To deeply investigate chasing behavior, participants were requested to indicate the reasons for stopping or continuing playing at the end of the experimental session.
RESULTS


Logistic regression analysis showed that the choice to stop or continue playing depended on experimental condition and alcohol use. Hierarchical linear regression indicated that chasing propensity was affected by experimental condition, alcohol consumption, and deficit in mentalization. The results of path analysis showed that hypermentalizing predicts chasing not only directly, but also indirectly via alcohol consumption.
CONCLUSIONS


Overall, these results for the first time showed that hypermentalization plays a key role in chasing behavior over and above gambling severity. Since these findings support the idea that chasers and non-chasers are different subtypes of gamblers, clinical interventions should consider the additive role of chasing in gambling disorder.",2019,"The results of path analysis showed that hypermentalizing predicts chasing not only directly, but also indirectly via alcohol consumption.
","['habitual gamblers', '132 adults took part in the study']",[],[],"[{'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0858352', 'cui_str': 'Gambler'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],[],132.0,0.0174562,"The results of path analysis showed that hypermentalizing predicts chasing not only directly, but also indirectly via alcohol consumption.
","[{'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Nigro', 'Affiliation': 'Department of Psychology, Università degli Studi della Campania ""Luigi Vanvitelli"", Caserta, Italy.'}, {'ForeName': 'Olimpia', 'Initials': 'O', 'LastName': 'Matarazzo', 'Affiliation': 'Department of Psychology, Università degli Studi della Campania ""Luigi Vanvitelli"", Caserta, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ciccarelli', 'Affiliation': 'Department of Psychology, Università degli Studi della Campania ""Luigi Vanvitelli"", Caserta, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': ""D'Olimpio"", 'Affiliation': 'Department of Psychology, Università degli Studi della Campania ""Luigi Vanvitelli"", Caserta, Italy.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Cosenza', 'Affiliation': 'Department of Psychology, Università degli Studi della Campania ""Luigi Vanvitelli"", Caserta, Italy.'}]",Journal of behavioral addictions,['10.1556/2006.8.2019.67']
3543,32074419,A Community-Based Intervention for Managing Hypertension in Rural South Asia.,"BACKGROUND


The burden of hypertension is escalating, and control rates are poor in low- and middle-income countries. Cardiovascular mortality is high in rural areas.
METHODS


We conducted a cluster-randomized, controlled trial in rural districts in Bangladesh, Pakistan, and Sri Lanka. A total of 30 communities were randomly assigned to either a multicomponent intervention (intervention group) or usual care (control group). The intervention involved home visits by trained government community health workers for blood-pressure monitoring and counseling, training of physicians, and care coordination in the public sector. A total of 2645 adults with hypertension were enrolled. The primary outcome was reduction in systolic blood pressure at 24 months. Follow-up at 24 months was completed for more than 90% of the participants.
RESULTS


At baseline, the mean systolic blood pressure was 146.7 mm Hg in the intervention group and 144.7 mm Hg in the control group. At 24 months, the mean systolic blood pressure fell by 9.0 mm Hg in the intervention group and by 3.9 mm Hg in the control group; the mean reduction was 5.2 mm Hg greater with the intervention (95% confidence interval [CI], 3.2 to 7.1; P<0.001). The mean reduction in diastolic blood pressure was 2.8 mm Hg greater in the intervention group than in the control group (95% CI, 1.7 to 3.9). Blood-pressure control (<140/90 mm Hg) was achieved in 53.2% of the participants in the intervention group, as compared with 43.7% of those in the control group (relative risk, 1.22; 95% CI, 1.10 to 1.35). All-cause mortality was 2.9% in the intervention group and 4.3% in the control group.
CONCLUSIONS


In rural communities in Bangladesh, Pakistan, and Sri Lanka, a multicomponent intervention that was centered on proactive home visits by trained government community health workers who were linked with existing public health care infrastructure led to a greater reduction in blood pressure than usual care among adults with hypertension. (Funded by the Joint Global Health Trials scheme; COBRA-BPS ClinicalTrials.gov number, NCT02657746.).",2020,"Hg greater in the intervention group than in the control group (95% CI, 1.7 to 3.9).","['2645 adults with hypertension were enrolled', 'adults with hypertension', 'In rural communities in Bangladesh, Pakistan, and Sri Lanka, a multicomponent intervention that was centered on proactive home visits by trained government community health workers', 'Managing Hypertension in Rural South Asia', 'rural districts in Bangladesh, Pakistan, and Sri Lanka', 'A total of 30 communities']","['home visits by trained government community health workers for blood-pressure monitoring and counseling, training of physicians, and care coordination in the public sector', 'multicomponent intervention (intervention group) or usual care (control group', 'Community-Based Intervention']","['systolic blood pressure', 'mean systolic blood pressure', 'Cardiovascular mortality', 'diastolic blood pressure', 'Blood-pressure control', 'All-cause mortality', 'mean systolic blood pressure fell', 'blood pressure', 'mean reduction']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C0038088', 'cui_str': 'Ceylon'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0026426', 'cui_str': 'Blood pressure monitoring'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0034035', 'cui_str': 'Public Sector'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",2645.0,0.0921861,"Hg greater in the intervention group than in the control group (95% CI, 1.7 to 3.9).","[{'ForeName': 'Tazeen H', 'Initials': 'TH', 'LastName': 'Jafar', 'Affiliation': 'From the Program in Health Services and Systems Research (T.H.J., E.A.F., L.F.) and the Center for Quantitative Medicine (M.G.), Duke-NUS Medical School, the Department of Renal Medicine, Singapore General Hospital (T.H.J.), and the Department of Biostatistics, Singapore Clinical Research Institute (M.G., P.N.A.) - all in Singapore; the Duke Global Health Institute (T.H.J., E.A.F., E.L.T.) and the Department of Biostatistics and Bioinformatics, Duke University (E.L.T.) - both in Durham, NC; the Center for Child Health Research, Tampere University, Tampere, Finland (M.G.); the Clinical Trials Unit, Department of Pharmacology (H.A.S.), and the Department of Public Health (A.K.), Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka; the Department of Community Health Sciences (I.J.) and the Section of Cardiology, Department of Medicine (A.H.K.), Aga Khan University, Karachi, Pakistan; the International Center for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh (A.N., J.D.C.); the UCLA Fielding School of Public Health, Department of Community Health Sciences, Los Angeles (D.M.); and the London School of Hygiene and Tropical Medicine, London (S.E.).'}, {'ForeName': 'Mihir', 'Initials': 'M', 'LastName': 'Gandhi', 'Affiliation': 'From the Program in Health Services and Systems Research (T.H.J., E.A.F., L.F.) and the Center for Quantitative Medicine (M.G.), Duke-NUS Medical School, the Department of Renal Medicine, Singapore General Hospital (T.H.J.), and the Department of Biostatistics, Singapore Clinical Research Institute (M.G., P.N.A.) - all in Singapore; the Duke Global Health Institute (T.H.J., E.A.F., E.L.T.) and the Department of Biostatistics and Bioinformatics, Duke University (E.L.T.) - both in Durham, NC; the Center for Child Health Research, Tampere University, Tampere, Finland (M.G.); the Clinical Trials Unit, Department of Pharmacology (H.A.S.), and the Department of Public Health (A.K.), Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka; the Department of Community Health Sciences (I.J.) and the Section of Cardiology, Department of Medicine (A.H.K.), Aga Khan University, Karachi, Pakistan; the International Center for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh (A.N., J.D.C.); the UCLA Fielding School of Public Health, Department of Community Health Sciences, Los Angeles (D.M.); and the London School of Hygiene and Tropical Medicine, London (S.E.).'}, {'ForeName': 'H Asita', 'Initials': 'HA', 'LastName': 'de Silva', 'Affiliation': 'From the Program in Health Services and Systems Research (T.H.J., E.A.F., L.F.) and the Center for Quantitative Medicine (M.G.), Duke-NUS Medical School, the Department of Renal Medicine, Singapore General Hospital (T.H.J.), and the Department of Biostatistics, Singapore Clinical Research Institute (M.G., P.N.A.) - all in Singapore; the Duke Global Health Institute (T.H.J., E.A.F., E.L.T.) and the Department of Biostatistics and Bioinformatics, Duke University (E.L.T.) - both in Durham, NC; the Center for Child Health Research, Tampere University, Tampere, Finland (M.G.); the Clinical Trials Unit, Department of Pharmacology (H.A.S.), and the Department of Public Health (A.K.), Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka; the Department of Community Health Sciences (I.J.) and the Section of Cardiology, Department of Medicine (A.H.K.), Aga Khan University, Karachi, Pakistan; the International Center for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh (A.N., J.D.C.); the UCLA Fielding School of Public Health, Department of Community Health Sciences, Los Angeles (D.M.); and the London School of Hygiene and Tropical Medicine, London (S.E.).'}, {'ForeName': 'Imtiaz', 'Initials': 'I', 'LastName': 'Jehan', 'Affiliation': 'From the Program in Health Services and Systems Research (T.H.J., E.A.F., L.F.) and the Center for Quantitative Medicine (M.G.), Duke-NUS Medical School, the Department of Renal Medicine, Singapore General Hospital (T.H.J.), and the Department of Biostatistics, Singapore Clinical Research Institute (M.G., P.N.A.) - all in Singapore; the Duke Global Health Institute (T.H.J., E.A.F., E.L.T.) and the Department of Biostatistics and Bioinformatics, Duke University (E.L.T.) - both in Durham, NC; the Center for Child Health Research, Tampere University, Tampere, Finland (M.G.); the Clinical Trials Unit, Department of Pharmacology (H.A.S.), and the Department of Public Health (A.K.), Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka; the Department of Community Health Sciences (I.J.) and the Section of Cardiology, Department of Medicine (A.H.K.), Aga Khan University, Karachi, Pakistan; the International Center for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh (A.N., J.D.C.); the UCLA Fielding School of Public Health, Department of Community Health Sciences, Los Angeles (D.M.); and the London School of Hygiene and Tropical Medicine, London (S.E.).'}, {'ForeName': 'Aliya', 'Initials': 'A', 'LastName': 'Naheed', 'Affiliation': 'From the Program in Health Services and Systems Research (T.H.J., E.A.F., L.F.) and the Center for Quantitative Medicine (M.G.), Duke-NUS Medical School, the Department of Renal Medicine, Singapore General Hospital (T.H.J.), and the Department of Biostatistics, Singapore Clinical Research Institute (M.G., P.N.A.) - all in Singapore; the Duke Global Health Institute (T.H.J., E.A.F., E.L.T.) and the Department of Biostatistics and Bioinformatics, Duke University (E.L.T.) - both in Durham, NC; the Center for Child Health Research, Tampere University, Tampere, Finland (M.G.); the Clinical Trials Unit, Department of Pharmacology (H.A.S.), and the Department of Public Health (A.K.), Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka; the Department of Community Health Sciences (I.J.) and the Section of Cardiology, Department of Medicine (A.H.K.), Aga Khan University, Karachi, Pakistan; the International Center for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh (A.N., J.D.C.); the UCLA Fielding School of Public Health, Department of Community Health Sciences, Los Angeles (D.M.); and the London School of Hygiene and Tropical Medicine, London (S.E.).'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Finkelstein', 'Affiliation': 'From the Program in Health Services and Systems Research (T.H.J., E.A.F., L.F.) and the Center for Quantitative Medicine (M.G.), Duke-NUS Medical School, the Department of Renal Medicine, Singapore General Hospital (T.H.J.), and the Department of Biostatistics, Singapore Clinical Research Institute (M.G., P.N.A.) - all in Singapore; the Duke Global Health Institute (T.H.J., E.A.F., E.L.T.) and the Department of Biostatistics and Bioinformatics, Duke University (E.L.T.) - both in Durham, NC; the Center for Child Health Research, Tampere University, Tampere, Finland (M.G.); the Clinical Trials Unit, Department of Pharmacology (H.A.S.), and the Department of Public Health (A.K.), Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka; the Department of Community Health Sciences (I.J.) and the Section of Cardiology, Department of Medicine (A.H.K.), Aga Khan University, Karachi, Pakistan; the International Center for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh (A.N., J.D.C.); the UCLA Fielding School of Public Health, Department of Community Health Sciences, Los Angeles (D.M.); and the London School of Hygiene and Tropical Medicine, London (S.E.).'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Turner', 'Affiliation': 'From the Program in Health Services and Systems Research (T.H.J., E.A.F., L.F.) and the Center for Quantitative Medicine (M.G.), Duke-NUS Medical School, the Department of Renal Medicine, Singapore General Hospital (T.H.J.), and the Department of Biostatistics, Singapore Clinical Research Institute (M.G., P.N.A.) - all in Singapore; the Duke Global Health Institute (T.H.J., E.A.F., E.L.T.) and the Department of Biostatistics and Bioinformatics, Duke University (E.L.T.) - both in Durham, NC; the Center for Child Health Research, Tampere University, Tampere, Finland (M.G.); the Clinical Trials Unit, Department of Pharmacology (H.A.S.), and the Department of Public Health (A.K.), Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka; the Department of Community Health Sciences (I.J.) and the Section of Cardiology, Department of Medicine (A.H.K.), Aga Khan University, Karachi, Pakistan; the International Center for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh (A.N., J.D.C.); the UCLA Fielding School of Public Health, Department of Community Health Sciences, Los Angeles (D.M.); and the London School of Hygiene and Tropical Medicine, London (S.E.).'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Morisky', 'Affiliation': 'From the Program in Health Services and Systems Research (T.H.J., E.A.F., L.F.) and the Center for Quantitative Medicine (M.G.), Duke-NUS Medical School, the Department of Renal Medicine, Singapore General Hospital (T.H.J.), and the Department of Biostatistics, Singapore Clinical Research Institute (M.G., P.N.A.) - all in Singapore; the Duke Global Health Institute (T.H.J., E.A.F., E.L.T.) and the Department of Biostatistics and Bioinformatics, Duke University (E.L.T.) - both in Durham, NC; the Center for Child Health Research, Tampere University, Tampere, Finland (M.G.); the Clinical Trials Unit, Department of Pharmacology (H.A.S.), and the Department of Public Health (A.K.), Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka; the Department of Community Health Sciences (I.J.) and the Section of Cardiology, Department of Medicine (A.H.K.), Aga Khan University, Karachi, Pakistan; the International Center for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh (A.N., J.D.C.); the UCLA Fielding School of Public Health, Department of Community Health Sciences, Los Angeles (D.M.); and the London School of Hygiene and Tropical Medicine, London (S.E.).'}, {'ForeName': 'Anuradhani', 'Initials': 'A', 'LastName': 'Kasturiratne', 'Affiliation': 'From the Program in Health Services and Systems Research (T.H.J., E.A.F., L.F.) and the Center for Quantitative Medicine (M.G.), Duke-NUS Medical School, the Department of Renal Medicine, Singapore General Hospital (T.H.J.), and the Department of Biostatistics, Singapore Clinical Research Institute (M.G., P.N.A.) - all in Singapore; the Duke Global Health Institute (T.H.J., E.A.F., E.L.T.) and the Department of Biostatistics and Bioinformatics, Duke University (E.L.T.) - both in Durham, NC; the Center for Child Health Research, Tampere University, Tampere, Finland (M.G.); the Clinical Trials Unit, Department of Pharmacology (H.A.S.), and the Department of Public Health (A.K.), Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka; the Department of Community Health Sciences (I.J.) and the Section of Cardiology, Department of Medicine (A.H.K.), Aga Khan University, Karachi, Pakistan; the International Center for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh (A.N., J.D.C.); the UCLA Fielding School of Public Health, Department of Community Health Sciences, Los Angeles (D.M.); and the London School of Hygiene and Tropical Medicine, London (S.E.).'}, {'ForeName': 'Aamir H', 'Initials': 'AH', 'LastName': 'Khan', 'Affiliation': 'From the Program in Health Services and Systems Research (T.H.J., E.A.F., L.F.) and the Center for Quantitative Medicine (M.G.), Duke-NUS Medical School, the Department of Renal Medicine, Singapore General Hospital (T.H.J.), and the Department of Biostatistics, Singapore Clinical Research Institute (M.G., P.N.A.) - all in Singapore; the Duke Global Health Institute (T.H.J., E.A.F., E.L.T.) and the Department of Biostatistics and Bioinformatics, Duke University (E.L.T.) - both in Durham, NC; the Center for Child Health Research, Tampere University, Tampere, Finland (M.G.); the Clinical Trials Unit, Department of Pharmacology (H.A.S.), and the Department of Public Health (A.K.), Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka; the Department of Community Health Sciences (I.J.) and the Section of Cardiology, Department of Medicine (A.H.K.), Aga Khan University, Karachi, Pakistan; the International Center for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh (A.N., J.D.C.); the UCLA Fielding School of Public Health, Department of Community Health Sciences, Los Angeles (D.M.); and the London School of Hygiene and Tropical Medicine, London (S.E.).'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Clemens', 'Affiliation': 'From the Program in Health Services and Systems Research (T.H.J., E.A.F., L.F.) and the Center for Quantitative Medicine (M.G.), Duke-NUS Medical School, the Department of Renal Medicine, Singapore General Hospital (T.H.J.), and the Department of Biostatistics, Singapore Clinical Research Institute (M.G., P.N.A.) - all in Singapore; the Duke Global Health Institute (T.H.J., E.A.F., E.L.T.) and the Department of Biostatistics and Bioinformatics, Duke University (E.L.T.) - both in Durham, NC; the Center for Child Health Research, Tampere University, Tampere, Finland (M.G.); the Clinical Trials Unit, Department of Pharmacology (H.A.S.), and the Department of Public Health (A.K.), Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka; the Department of Community Health Sciences (I.J.) and the Section of Cardiology, Department of Medicine (A.H.K.), Aga Khan University, Karachi, Pakistan; the International Center for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh (A.N., J.D.C.); the UCLA Fielding School of Public Health, Department of Community Health Sciences, Los Angeles (D.M.); and the London School of Hygiene and Tropical Medicine, London (S.E.).'}, {'ForeName': 'Shah', 'Initials': 'S', 'LastName': 'Ebrahim', 'Affiliation': 'From the Program in Health Services and Systems Research (T.H.J., E.A.F., L.F.) and the Center for Quantitative Medicine (M.G.), Duke-NUS Medical School, the Department of Renal Medicine, Singapore General Hospital (T.H.J.), and the Department of Biostatistics, Singapore Clinical Research Institute (M.G., P.N.A.) - all in Singapore; the Duke Global Health Institute (T.H.J., E.A.F., E.L.T.) and the Department of Biostatistics and Bioinformatics, Duke University (E.L.T.) - both in Durham, NC; the Center for Child Health Research, Tampere University, Tampere, Finland (M.G.); the Clinical Trials Unit, Department of Pharmacology (H.A.S.), and the Department of Public Health (A.K.), Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka; the Department of Community Health Sciences (I.J.) and the Section of Cardiology, Department of Medicine (A.H.K.), Aga Khan University, Karachi, Pakistan; the International Center for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh (A.N., J.D.C.); the UCLA Fielding School of Public Health, Department of Community Health Sciences, Los Angeles (D.M.); and the London School of Hygiene and Tropical Medicine, London (S.E.).'}, {'ForeName': 'Pryseley N', 'Initials': 'PN', 'LastName': 'Assam', 'Affiliation': 'From the Program in Health Services and Systems Research (T.H.J., E.A.F., L.F.) and the Center for Quantitative Medicine (M.G.), Duke-NUS Medical School, the Department of Renal Medicine, Singapore General Hospital (T.H.J.), and the Department of Biostatistics, Singapore Clinical Research Institute (M.G., P.N.A.) - all in Singapore; the Duke Global Health Institute (T.H.J., E.A.F., E.L.T.) and the Department of Biostatistics and Bioinformatics, Duke University (E.L.T.) - both in Durham, NC; the Center for Child Health Research, Tampere University, Tampere, Finland (M.G.); the Clinical Trials Unit, Department of Pharmacology (H.A.S.), and the Department of Public Health (A.K.), Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka; the Department of Community Health Sciences (I.J.) and the Section of Cardiology, Department of Medicine (A.H.K.), Aga Khan University, Karachi, Pakistan; the International Center for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh (A.N., J.D.C.); the UCLA Fielding School of Public Health, Department of Community Health Sciences, Los Angeles (D.M.); and the London School of Hygiene and Tropical Medicine, London (S.E.).'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': 'From the Program in Health Services and Systems Research (T.H.J., E.A.F., L.F.) and the Center for Quantitative Medicine (M.G.), Duke-NUS Medical School, the Department of Renal Medicine, Singapore General Hospital (T.H.J.), and the Department of Biostatistics, Singapore Clinical Research Institute (M.G., P.N.A.) - all in Singapore; the Duke Global Health Institute (T.H.J., E.A.F., E.L.T.) and the Department of Biostatistics and Bioinformatics, Duke University (E.L.T.) - both in Durham, NC; the Center for Child Health Research, Tampere University, Tampere, Finland (M.G.); the Clinical Trials Unit, Department of Pharmacology (H.A.S.), and the Department of Public Health (A.K.), Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka; the Department of Community Health Sciences (I.J.) and the Section of Cardiology, Department of Medicine (A.H.K.), Aga Khan University, Karachi, Pakistan; the International Center for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh (A.N., J.D.C.); the UCLA Fielding School of Public Health, Department of Community Health Sciences, Los Angeles (D.M.); and the London School of Hygiene and Tropical Medicine, London (S.E.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1911965']
3544,31132546,New vaccines and antiviral drugs for cytomegalovirus.,"The natural history of cytomegalovirus (CMV) infection in transplant patients has been well established. This virus may originate from the recipient, the donor or both. When pre-transplant IgG antibodies in the recipient are taken into account, three types of infection are possible: primary, reactivation or reinfection. The risks of high viral load and end-organ disease are highest after primary infection and lowest after reactivation. Serial monitoring of patients by quantitative polymerase chain reaction for CMV DNA allows antiviral drugs to be deployed for pre-emptive therapy or an antiviral drug may be given prophylactically. Both of these strategies are effective, but pre-emptive therapy has the advantage that randomised allocation of a new drug or placebo given prophylactically may show a reduced need for pre-emptive valganciclovir. In this review, I will consider what has been learned from use of ganciclovir and valganciclovir and apply this information to clinical trials that have evaluated maribavir, brincidofovir and letermovir. In addition, pre-emptive therapy has the advantage of facilitating the discovery of vaccines against CMV using a pharmacodynamic approach. Briefly, patients awaiting transplantation are given vaccine or placebo pre-transplant. When they proceed to transplantation, various parameters of viral load can be compared to determine if the vaccine has an effect against CMV when compared to patients randomised to receive placebo. If there is evidence of control of CMV, this can be related to immune responses induced by the vaccine to define a correlate of protection. This review will summarise the published evidence available.",2019,The risks of high viral load and end-organ disease are highest after primary infection and lowest after reactivation.,"['transplant patients', 'patients awaiting transplantation are given vaccine or placebo pre-transplant']","['ganciclovir and valganciclovir', 'placebo']",[],"[{'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]","[{'cui': 'C0017066', 'cui_str': 'Ganciclovir'}, {'cui': 'C0909381', 'cui_str': 'valganciclovir'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.126768,The risks of high viral load and end-organ disease are highest after primary infection and lowest after reactivation.,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Griffiths', 'Affiliation': 'Institute for Immunity & Transplantation, Royal Free Campus, UCL, London, NW3 2PF, United Kingdom. Electronic address: p.griffiths@ucl.ac.uk.'}]",Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology,['10.1016/j.jcv.2019.04.007']
3545,31838406,A multicentric randomized phase II clinical trial evaluating high-dose thiotepa as adjuvant treatment to standard chemotherapy in patients with resectable relapsed osteosarcoma.,"BACKGROUND


The role of high-dose chemotherapy in relapsing osteosarcomas has not been established. We evaluated the efficacy and tolerance of high-dose thiotepa (HDTp) after standard chemotherapy (SCT) in patients with relapsed osteosarcoma.
PATIENTS AND METHODS


This randomised open-label phase II study enrolled patients 1-50 years, with local or metastatic relapse of a high-grade osteosarcoma, not progressive after two cycles of SCT, for whom a complete surgery can be achievable following treatment. The trial assigned enrolled patients in a 1:1 ratio to receive two additional courses of SCT + HDTp and autologous transplantation (Arm A), or SCT alone (Arm B). Surgery for complete resection was scheduled as soon as feasible. Primary endpoint was overall survival (OS). Secondary objectives included progression-free survival (PFS) and safety.
RESULTS


From September 2009 to November 2016, 44 patients were randomised (A:22; B:22). In total, 54.5% were males, and the median age was 16 years (9-32years). The two-year OS rate was 66.7% (95% CI 42.5-82.5) (SCT + HDTp, Arm A) versus 50.0% (95% CI 28.2-68.4) for SCT alone (Arm B). Median OS was 27.4 and 24.8 months, respectively (hazard ratio [HR] 0.826, 95% CI 0.393-1.734; p = 0.6123). Median PFS was 15.6 (8.9-24.9) months in Arm A versus 7.2 (4.8-33.3) months in Arm B, p = 0.3845. Among the 22 patients treated with SCT + HDTp, 16 (72.7%) experienced at least one grade ≥3 adverse events versus 18/22 (81.8%) patients treated with SCT. No toxic death occurred.
CONCLUSION


Adjuvant HDTp failed to significantly improve OS and PFS in resectable relapsed osteosarcomas. Despite a trend of prolonged survival and an acceptable toxicity, thiotepa cannot be recommended.
KEY MESSAGE


HDTp and autologous transplantation added to SCT did not improve OS and PFS in patients with resectable relapsed osteosarcomas. Despite a trend of prolonged survival, thiotepa cannot be recommended.",2020,"The two-year OS rate was 66.7% (95% CI 42.5-82.5) (SCT + HDTp, Arm A) versus 50.0% (95% CI 28.2-68.4) for SCT alone (Arm B).","['patients with resectable relapsed osteosarcoma', 'From September 2009 to November 2016, 44 patients', 'In total, 54.5% were males, and the median age was 16 years (9-32years', 'patients with relapsed osteosarcoma', 'patients with resectable relapsed osteosarcomas', 'enrolled patients 1-50 years, with local or metastatic relapse of a high-grade osteosarcoma, not progressive after two cycles of SCT, for whom a complete surgery can be achievable following treatment']","['standard chemotherapy', 'SCT', 'SCT\xa0+\xa0HDTp and autologous transplantation (Arm A), or SCT alone', 'high-dose thiotepa (HDTp) after standard chemotherapy (SCT']","['prolonged survival', 'efficacy and tolerance', 'grade ≥3 adverse events', 'OS and PFS', 'progression-free survival (PFS)\xa0and safety', 'overall survival (OS', 'toxic death', 'Median OS', 'Median PFS', 'OS rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0029463', 'cui_str': 'Sarcoma, Osteogenic'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0039871', 'cui_str': 'Thiotepa'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",44.0,0.152844,"The two-year OS rate was 66.7% (95% CI 42.5-82.5) (SCT + HDTp, Arm A) versus 50.0% (95% CI 28.2-68.4) for SCT alone (Arm B).","[{'ForeName': 'Perrine', 'Initials': 'P', 'LastName': 'Marec-Berard', 'Affiliation': 'Paediatric Department, Hematology and Oncology Pediatric Institute, Centre Léon Bérard, Lyon, France. Electronic address: perrine.marec-berard@ihope.fr.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Dalban', 'Affiliation': 'Department of Clinical Research and Innovation, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Gaspar', 'Affiliation': 'Department of Pediatrics and Adolescents Oncology, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Brugieres', 'Affiliation': 'Department of Pediatrics and Adolescents Oncology, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Gentet', 'Affiliation': 'Department of Pediatric Hematology and Oncology, La Timone Hospital, Marseille, France.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Lervat', 'Affiliation': 'Department of Pediatric Oncology, Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'Nadège', 'Initials': 'N', 'LastName': 'Corradini', 'Affiliation': 'Department of Pediatric Hematology and Oncology, CHU Nantes, Nantes, France.'}, {'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'Castex', 'Affiliation': 'Paediatric Department, Hospital Centre, Toulouse, France.'}, {'ForeName': 'Claudine', 'Initials': 'C', 'LastName': 'Schmitt', 'Affiliation': 'Pediatric Hospital, CHU Nancy, Vandoeuvre-les-Nancy, France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Pacquement', 'Affiliation': 'Pediatric Oncology Department, Institut Curie, Paris, France.'}, {'ForeName': 'Marie-Dominique', 'Initials': 'MD', 'LastName': 'Tabone', 'Affiliation': 'Department of Pediatric Hematology and Oncology, A.Trousseau Hospital, APHP, Paris, France.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Brahmi', 'Affiliation': 'Department of Medical Oncology, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Séverine', 'Initials': 'S', 'LastName': 'Metzger', 'Affiliation': 'Department of Clinical Research and Innovation, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Blay', 'Affiliation': 'Department of Medical Oncology & Claude Bernard University, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pérol', 'Affiliation': 'Department of Clinical Research and Innovation, Centre Léon Bérard, Lyon, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.11.007']
3546,30576539,Gonadotrophins versus clomiphene citrate with or without IUI in women with normogonadotropic anovulation and clomiphene failure: a cost-effectiveness analysis.,"STUDY QUESTION


Are six cycles of ovulation induction with gonadotrophins more cost-effective than six cycles of ovulation induction with clomiphene citrate (CC) with or without IUI in normogonadotropic anovulatory women not pregnant after six ovulatory cycles with CC?
SUMMARY ANSWER


Both gonadotrophins and IUI are more expensive when compared with CC and intercourse, and gonadotrophins are more effective than CC.
WHAT IS KNOWN ALREADY


In women with normogonadotropic anovulation who ovulate but do not conceive after six cycles with CC, medication is usually switched to gonadotrophins, with or without IUI. The cost-effectiveness of these changes in policy is unknown.
STUDY DESIGN, SIZE, DURATION


We performed an economic evaluation of ovulation induction with gonadotrophins compared with CC with or without IUI in a two-by-two factorial multicentre randomized controlled trial in normogonadotropic anovulatory women not pregnant after six ovulatory cycles with CC. Between December 2008 and December 2015 women were allocated to six cycles with gonadotrophins plus IUI, six cycles with gonadotrophins plus intercourse, six cycles with CC plus IUI or six cycles with CC plus intercourse. The primary outcome was conception leading to a live birth achieved within 8 months of randomization.
PARTICIPANTS/MATERIALS, SETTING, METHODS


We performed a cost-effectiveness analysis on direct medical costs. We calculated the direct medical costs of ovulation induction with gonadotrophins versus CC and of IUI versus intercourse in six subsequent cycles. We included costs of medication, cycle monitoring, interventions, and pregnancy leading to live birth. Resource use was collected from the case report forms and unit costs were derived from various sources. We calculated incremental cost-effectiveness ratios (ICER) for gonadotrophins compared to CC and for IUI compared to intercourse. We used non-parametric bootstrap resampling to investigate the effect of uncertainty in our estimates. The analysis was performed according to the intention-to-treat principle.
MAIN RESULTS AND THE ROLE OF CHANCE


We allocated 666 women in total to gonadotrophins and IUI (n = 166), gonadotrophins and intercourse (n = 165), CC and IUI (n = 163), or CC and intercourse (n = 172). Mean direct medical costs per woman receiving gonadotrophins or CC were €4495 versus €3006 (cost difference of €1475 (95% CI: €1457-€1493)). Live birth rates were 52% in women allocated to gonadotrophins and 41% in those allocated to CC (relative risk (RR) 1.24:95% CI: 1.05-1.46). The ICER was €15 258 (95% CI: €8721 to €63 654) per additional live birth with gonadotrophins. Mean direct medical costs per woman allocated to IUI or intercourse were €4497 versus €3005 (cost difference of €1510 (95% CI: €1492-€1529)). Live birth rates were 49% in women allocated to IUI and 43% in those allocated to intercourse (RR = 1.14:95% CI: 0.97-1.35). The ICER was €24 361 (95% CI: €-11 290 to €85 172) per additional live birth with IUI.
LIMITATIONS, REASONS FOR CAUTION


We allowed participating hospitals to use their local protocols for ovulation induction and IUI, which may have led to variation in costs, but which increases generalizability. Indirect costs generated by transportation or productivity loss were not included. We did not evaluate letrozole, which is potentially more effective than CC.
WIDER IMPLICATIONS OF THE FINDINGS


Gonadotrophins are more effective, but more expensive than CC, therefore, the use of gonadotrophins in women with normogonadotropic anovulation who have not conceived after six ovulatory CC cycles depends on society's willingness to pay for an additional child. In view of the uncertainty around the cost-effectiveness estimate of IUI, these data are not sufficient to make recommendations on the use of IUI in these women. In countries where ovulation induction regimens are reimbursed, policy makers and health care professionals may use our results in their guidelines.
STUDY FUNDING/COMPETING INTEREST(S)


This trial was funded by the Netherlands Organization for Health Research and Development (ZonMw number: 80-82310-97-12067). The Eudract number for this trial is 2008-006171-73. The Sponsor's Protocol Code Number is P08-40. CBLA reports unrestricted grant support from Merck and Ferring. BWM is supported by a NHMRC Practitioner Fellowship (GNT1082548) and reports consultancy for Merck, ObsEva and Guerbet.
TRIAL REGISTRATION NUMBER


NTR1449.",2019,The ICER was €15 258 (95% CI: €8721 to €63 654) per additional live birth with gonadotrophins.,"['women with normogonadotropic anovulation', '666 women in total to gonadotrophins and IUI (n = 166), gonadotrophins and intercourse (n = 165), CC and IUI (n = 163), or CC and intercourse (n = 172', 'normogonadotropic anovulatory women not pregnant after six ovulatory cycles with CC', ""women with normogonadotropic anovulation who have not conceived after six ovulatory CC cycles depends on society's willingness to pay for an additional child"", 'women with normogonadotropic anovulation and clomiphene failure', 'Between December 2008 and December 2015 women']","['gonadotrophins compared with CC with or without IUI', 'gonadotrophins versus CC and of IUI', 'Gonadotrophins versus clomiphene citrate with or without IUI', 'gonadotrophins plus IUI, six cycles with gonadotrophins plus intercourse, six cycles with CC plus IUI or six cycles with CC plus intercourse', 'clomiphene citrate (CC', 'letrozole', 'gonadotrophins']","['incremental cost-effectiveness ratios (ICER', 'ICER', 'Live birth rates', 'Mean direct medical costs', 'costs of medication, cycle monitoring, interventions, and pregnancy leading to live birth', 'conception leading to a live birth achieved within 8 months of randomization', 'Mean direct medical costs per woman allocated to IUI or intercourse', 'cost-effectiveness', 'additional live birth with IUI']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0003128', 'cui_str': 'Anovulation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0009253', 'cui_str': 'Sexual Intercourse'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C0429468', 'cui_str': 'Anovulatory (finding)'}, {'cui': 'C0232973', 'cui_str': 'Not pregnant (finding)'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory (finding)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009008', 'cui_str': 'Clomiphene'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]","[{'cui': 'C0546642', 'cui_str': 'Gonadotrophins'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene Citrate'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0009253', 'cui_str': 'Sexual Intercourse'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0009253', 'cui_str': 'Sexual Intercourse'}]",666.0,0.208092,The ICER was €15 258 (95% CI: €8721 to €63 654) per additional live birth with gonadotrophins.,"[{'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Bordewijk', 'Affiliation': 'Center for Reproductive Medicine, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'N S', 'Initials': 'NS', 'LastName': 'Weiss', 'Affiliation': 'Center for Reproductive Medicine, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Nahuis', 'Affiliation': 'Center for Reproductive Medicine, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Bayram', 'Affiliation': 'Department of Obstetrics and Gynaecology, Zaans Medisch Centrum, Zaandam, The Netherlands.'}, {'ForeName': 'M H A', 'Initials': 'MHA', 'LastName': 'van Hooff', 'Affiliation': 'Department of Obstetrics and Gynaecology, Sint Franciscus Gasthuis, Rotterdam, The Netherlands.'}, {'ForeName': 'D E S', 'Initials': 'DES', 'LastName': 'Boks', 'Affiliation': 'Department of Obstetrics and Gynaecology, Spaarne Gasthuis, Hoofddorp, The Netherlands.'}, {'ForeName': 'D A M', 'Initials': 'DAM', 'LastName': 'Perquin', 'Affiliation': 'Department of Obstetrics and Gynaecology, Medical Center Leeuwarden, Leeuwarden, The Netherlands.'}, {'ForeName': 'C A H', 'Initials': 'CAH', 'LastName': 'Janssen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Groene Hart Ziekenhuis, Gouda, The Netherlands.'}, {'ForeName': 'R J T', 'Initials': 'RJT', 'LastName': 'van Golde', 'Affiliation': 'Department of Obstetrics and Gynecology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'C B', 'Initials': 'CB', 'LastName': 'Lambalk', 'Affiliation': 'Center for Reproductive Medicine, VU Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Goddijn', 'Affiliation': 'Center for Reproductive Medicine, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Hompes', 'Affiliation': 'Center for Reproductive Medicine, VU Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'van der Veen', 'Affiliation': 'Center for Reproductive Medicine, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'B W J', 'Initials': 'BWJ', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Melbourne, Australia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van Wely', 'Affiliation': 'Center for Reproductive Medicine, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Human reproduction (Oxford, England)",['10.1093/humrep/dey359']
3547,31704050,Paradoxical Response of Parathyroid Hormone to Vitamin D-Calcium Supplementation in Indian Children.,"OBJECTIVES


To investigate the effect of oral vitamin D-calcium supplementation on serum intact parathyroid hormone (PTH), calcium, phosphorous, and alkaline phosphatase (ALK-P) concentrations in children with habitually low calcium intakes.
STUDY DESIGN


In this follow-up study to a randomized controlled trial that aimed to assess the effect of vitamin D-calcium supplementation on immunity, data related to dietary intake, anthropometry, and biochemistry [serum 25(OH)D and bone profile] were collected from 178 children-79 in the vitamin D group and 99 in the non-vitamin D group.
RESULTS


Dietary calcium to phosphorus intake ratio was 0.4:1. Baseline serum 25(OH)D concentration was 58.2 ± 10.9 nmol/L; 66% children were vitamin D sufficient and none deficient. After supplementation, vitamin D group, compared with the non-vitamin D group, had significantly (P < .05) greater 25(OH)D (83.9 ± 30.1 nmol/L vs 58.3 ± 15.7 nmol/L), significantly greater PTH (6.7 ± 3.6 pmol/L vs 5.5 ± 3.2 pmol/L), and positive correlation (r s  = 0.24) between serum 25(OH)D and PTH (vs negative correlation [r s  = -0.1] in non-vitamin D group). Mean concentrations of serum bone measures in the vitamin D group were calcium (2.2 ± 0.1 mmol/L), phosphorus (1.7 ± 0.2 mmol/L), and ALK-P (178.7 ± 40.7 IU/L). At follow-up, 1-year post-supplementation, in the vitamin D group, PTH concentrations continued to remain high (but not significantly different from levels at 6 months), with low normal serum calcium, high normal phosphate, and ALK-P in reference range.
CONCLUSIONS


In children who are vitamin D sufficient but with habitually low dietary calcium intake, vitamin D-calcium supplementation paradoxically and significantly increased serum PTH concentrations with no apparent effect on other bone biochemistry. Chronic low dietary calcium to phosphorus ratio is likely to have caused this paradoxical response.",2020,"After supplementation, vitamin D group, compared with the non-vitamin D group, had significantly (P < .05) greater 25(OH)D (83.9 ± 30.1 nmol/L vs 58.3 ± 15.7 nmol/L), significantly greater PTH (6.7 ± 3.6 pmol/L vs 5.5 ± 3.2 pmol/L), and positive correlation","['children with habitually low calcium intakes', '178 children-79 in the vitamin D group and 99 in the non-vitamin D group', 'Indian Children']","['oral vitamin D-calcium supplementation', 'vitamin D', 'vitamin D-calcium supplementation', 'Parathyroid Hormone to Vitamin D-Calcium Supplementation']","['serum PTH concentrations', 'serum intact parathyroid hormone (PTH), calcium, phosphorous, and alkaline phosphatase (ALK-P) concentrations', 'serum 25(OH)D and PTH', 'Baseline serum 25(OH)D concentration', 'Mean concentrations of serum bone measures', 'immunity, data related to dietary intake, anthropometry, and biochemistry [serum 25(OH)D and bone profile']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0489458', 'cui_str': 'Calcium intake (observable entity)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy (regime/therapy)'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0002059', 'cui_str': 'Orthophosphoric-monoester phosphohydrolase (alkaline optimum)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0020964', 'cui_str': 'Immunity'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0430041', 'cui_str': 'Bone profile (procedure)'}]",,0.119588,"After supplementation, vitamin D group, compared with the non-vitamin D group, had significantly (P < .05) greater 25(OH)D (83.9 ± 30.1 nmol/L vs 58.3 ± 15.7 nmol/L), significantly greater PTH (6.7 ± 3.6 pmol/L vs 5.5 ± 3.2 pmol/L), and positive correlation","[{'ForeName': 'Rubina M', 'Initials': 'RM', 'LastName': 'Mandlik', 'Affiliation': 'Hirabai Cowasji Jehangir Medical Research Institute, Jehangir Hospital, Maharashtra, India; Interdisciplinary School of Health Sciences, Savitribai Phule Pune University, Maharashtra, India.'}, {'ForeName': 'Zulf M', 'Initials': 'ZM', 'LastName': 'Mughal', 'Affiliation': ""Department of Pediatric Endocrinology & Metabolic Bone Diseases, Royal Manchester Children's Hospital, Manchester, UK; Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.""}, {'ForeName': 'Anuradha V', 'Initials': 'AV', 'LastName': 'Khadilkar', 'Affiliation': 'Hirabai Cowasji Jehangir Medical Research Institute, Jehangir Hospital, Maharashtra, India; Interdisciplinary School of Health Sciences, Savitribai Phule Pune University, Maharashtra, India. Electronic address: anuradhavkhadilkar@gmail.com.'}, {'ForeName': 'Veena H', 'Initials': 'VH', 'LastName': 'Ekbote', 'Affiliation': 'Hirabai Cowasji Jehangir Medical Research Institute, Jehangir Hospital, Maharashtra, India.'}, {'ForeName': 'Neha A', 'Initials': 'NA', 'LastName': 'Kajale', 'Affiliation': 'Hirabai Cowasji Jehangir Medical Research Institute, Jehangir Hospital, Maharashtra, India.'}, {'ForeName': 'Vivek G', 'Initials': 'VG', 'LastName': 'Patwardhan', 'Affiliation': 'Hirabai Cowasji Jehangir Medical Research Institute, Jehangir Hospital, Maharashtra, India.'}, {'ForeName': 'Vaman V', 'Initials': 'VV', 'LastName': 'Khadilkar', 'Affiliation': 'Hirabai Cowasji Jehangir Medical Research Institute, Jehangir Hospital, Maharashtra, India.'}, {'ForeName': 'Raja', 'Initials': 'R', 'LastName': 'Padidela', 'Affiliation': ""Department of Pediatric Endocrinology & Metabolic Bone Diseases, Royal Manchester Children's Hospital, Manchester, UK; Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.""}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.09.028']
3548,30907291,Changing the perception of premenstrual dysphoric disorder - An online-experiment using the Stereotype Content Model.,"Women with Premenstrual Dysphoric Disorder (PMDD) are often faced with prejudices about the premenstrual phase. The aim of this study was to investigate whether providing information (psychoeducation) could improve study participants' perception of a PMDD-patient and whether experimentally-induced prejudices about PMDD resulted in stigmatization. Two hundred sixteen students (50% female; aged 18-42 years) from Philipps University Marburg participated in January 2014. Participants were randomly assigned to one of two experimental groups (EG1, EG2) or to a control group (CG). EG1 read a text informing about PMDD. EG2 read a text with stereotypic PMDD-information. CG received a text with information unrelated to PMDD. Then, all participants watched a video of a woman reporting about her PMDD. Finally, participants appraised the woman on the cognitive dimensions warmth and competence as well as on PMDD-related attributes (depressive symptoms, emotional regulation). Participants of EG1 rated the woman as warmer ( p  <  .001), more competent ( p  =  .006), and with less depressive symptoms ( p  < .001) than the CG. The results by study group did not differ by gender. Stereotypic information did not differ significantly among the study groups. Psychoeducation can facilitate the understanding of PMDD-patients and should be integrated in future research on PMDD-treatments.",2019,"Participants of EG1 rated the woman as warmer (p <  .001), more competent (p =  .006), and with less depressive symptoms (p < .001) than the CG.","['Women with Premenstrual Dysphoric Disorder (PMDD', 'Two hundred sixteen students (50% female; aged 18-42\xa0years) from Philipps University Marburg participated in January 2014']","['providing information (psychoeducation', 'control group (CG']","['cognitive dimensions warmth and competence as well as on PMDD-related attributes (depressive symptoms, emotional regulation', 'depressive symptoms', 'Stereotypic information']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0520676', 'cui_str': 'Premenstrual Dysphoric Syndrome'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]","[{'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0449234', 'cui_str': 'Attribute (attribute)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}]",,0.0377329,"Participants of EG1 rated the woman as warmer (p <  .001), more competent (p =  .006), and with less depressive symptoms (p < .001) than the CG.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Janda', 'Affiliation': 'Department of Psychology, Division of Clinical Psychology and Psychotherapy, Philipps University Marburg , Marburg , Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Asbrock', 'Affiliation': 'Department of Psychology, Technische Universität Chemnitz , Chemnitz , Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Herget', 'Affiliation': 'Department of Psychology, Division of Clinical Psychology and Psychotherapy, Philipps University Marburg , Marburg , Germany.'}, {'ForeName': 'J N', 'Initials': 'JN', 'LastName': 'Kues', 'Affiliation': 'Department of Psychology, Division of Clinical Psychology and Psychotherapy, Philipps University Marburg , Marburg , Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Weise', 'Affiliation': 'Department of Psychology, Division of Clinical Psychology and Psychotherapy, Philipps University Marburg , Marburg , Germany.'}]",Women & health,['10.1080/03630242.2019.1584599']
3549,31033046,"Flushing of peripheral intravenous catheters: A pilot, factorial, randomised controlled trial of high versus low frequency and volume in paediatrics.","AIM


To test the feasibility of an efficacy trial comparing different flushing frequencies and volumes to reduce peripheral intravenous cannula (PIVC) failure in paediatric inpatients.
METHODS


Pilot, 2 × 2 factorial, randomised controlled trial comparing PIVC flushing techniques in intervention pairs: (i) low volume (3 mL) versus high volume (10 mL); and (ii) low frequency (24 hourly) versus high frequency (6 hourly). Patients were excluded if: fluids were restricted, weight < 5 kg, PIVC already in situ for >24 h or continuous infusion. The primary end-point was feasibility (eligibility, recruitment, retention, protocol adherence, missing data and sample size estimates) of a large trial. Secondary end-points were PIVC failure (composite and individual), bloodstream infection and mortality.
RESULTS


A total of 919 children were screened from April to November 2015, with 55 enrolled. Screening feasibility criteria were not met, mainly due to continuous infusions and PIVCs in situ >24 h or planned for imminent removal. However, 80% of eligible participants consented, 2% withdrew, protocol adherence was 100%, and there was no missing primary end-point data. PIVC failure was significantly higher (hazard ratio = 2.90, 95% confidence interval: 1.11-7.54) in the 3 mL compared to the 10 mL group. There was no difference in failure between frequency groups (hazard ratio = 0.91, 95% confidence interval: 0.36-2.33). There was no interaction effect (P = 0.22).
CONCLUSION


Trial feasibility proved challenging due to eligibility criteria, which could be improved with additional recruiting staff. Firm conclusions cannot be made based on this small sample, but flush volume may impact PIVC failure.",2020,"PIVC failure was significantly higher (hazard ratio = 2.90, 95% confidence interval: 1.11-7.54) in the 3 mL compared to the 10 mL group.","['Patients were excluded if: fluids were restricted, weight\u2009<\u20095 kg, PIVC already in situ for >24\u2009h or continuous infusion', 'paediatrics', 'paediatric inpatients', '919 children were screened from April to November 2015, with 55 enrolled']",['peripheral intravenous catheters'],"['PIVC failure', 'failure', 'feasibility (eligibility, recruitment, retention, protocol adherence, missing data and sample size estimates', 'PIVC failure (composite and individual), bloodstream infection and mortality', 'peripheral intravenous cannula (PIVC) failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0444498', 'cui_str': 'In situ (qualifier value)'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C0179768', 'cui_str': 'Peripheral intravenous catheter, device (physical object)'}]","[{'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}]",919.0,0.493885,"PIVC failure was significantly higher (hazard ratio = 2.90, 95% confidence interval: 1.11-7.54) in the 3 mL compared to the 10 mL group.","[{'ForeName': 'Tricia M', 'Initials': 'TM', 'LastName': 'Kleidon', 'Affiliation': ""Department of Anaesthetics, Queensland Children's Hospital, Brisbane, Queensland, Australia.""}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Keogh', 'Affiliation': 'Alliance for Vascular Access Teaching and Research (AVATAR), Menzies Heath Institute Queensland, Griffith University, Brisbane, Queensland, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Flynn', 'Affiliation': 'Alliance for Vascular Access Teaching and Research (AVATAR), Menzies Heath Institute Queensland, Griffith University, Brisbane, Queensland, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Schults', 'Affiliation': ""Department of Anaesthetics, Queensland Children's Hospital, Brisbane, Queensland, Australia.""}, {'ForeName': 'Gabor', 'Initials': 'G', 'LastName': 'Mihala', 'Affiliation': 'Alliance for Vascular Access Teaching and Research (AVATAR), Menzies Heath Institute Queensland, Griffith University, Brisbane, Queensland, Australia.'}, {'ForeName': 'Claire M', 'Initials': 'CM', 'LastName': 'Rickard', 'Affiliation': 'Alliance for Vascular Access Teaching and Research (AVATAR), Menzies Heath Institute Queensland, Griffith University, Brisbane, Queensland, Australia.'}]",Journal of paediatrics and child health,['10.1111/jpc.14482']
3550,31690831,Randomised Phase 2 study of lapatinib and vinorelbine vs vinorelbine in patients with HER2 + metastatic breast cancer after lapatinib and trastuzumab treatment (KCSG BR11-16).,"BACKGROUND


The continuum of anti-HER2 agents is a standard treatment of HER2 + metastatic breast cancer (MBC). This study evaluated the efficacy of lapatinib plus vinorelbine in patients progressed on both trastuzumab and lapatinib treatments.
METHODS


A total of 149 patients were randomly assigned to lapatinib with vinorelbine (LV) (n = 75; lapatinib, 1000 mg daily; vinorelbine 20 mg/m 2  D1, D8 q3w) or vinorelbine (V) (n = 74; 30 mg/m 2  D1, D8 q3w). The primary endpoint was progression-free survival (PFS) rate at 18 weeks.
RESULTS


The median number of previous anti-HER2 therapies was 2 (range 2-5). There was no significant difference in PFS rate at 18 weeks between LV and V arms (45.9% vs 38.9%, p = 0.40). ORR was 19.7% in LV arm, and 16.9% in V arm (p = 0.88). PFS and OS did not differ between two arms (LV vs V; median PFS, 16 vs 12 weeks, HR = 0.86, 95% CI 0.61-1.22; median OS, 15.0 vs 18.9 months, HR = 1.07, 95% CI 0.72-1.58). Toxicity profiles were similar in both arms and all were manageable.
CONCLUSIONS


Lapatinib plus vinorelbine treatment was tolerable; however, it failed to demonstrate the clinical benefits over vinorelbine alone in patients with HER2 + MBC after progression on both trastuzumab and lapatinib.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov number NCT01730677.",2019,"PFS and OS did not differ between two arms (LV vs V; median PFS, 16 vs 12 weeks, HR = 0.86, 95% CI 0.61-1.22; median OS, 15.0 vs 18.9 months, HR = 1.07, 95% CI 0.72-1.58).","['patients progressed on both trastuzumab and lapatinib treatments', 'A total of 149 patients', 'patients with HER2\u2009+\u2009metastatic breast cancer after lapatinib and trastuzumab treatment (KCSG BR11-16']","['Lapatinib plus vinorelbine', 'lapatinib with vinorelbine (LV) (n\u2009=\u200975; lapatinib, 1000\u2009mg daily; vinorelbine 20\u2009mg/m 2  D1, D8 q3w) or vinorelbine (V', 'lapatinib and vinorelbine vs vinorelbine', 'vinorelbine', 'lapatinib plus vinorelbine']","['ORR', 'median number of previous anti-HER2 therapies', 'Toxicity profiles', 'progression-free survival (PFS) rate', 'PFS and OS', 'PFS rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}]","[{'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",149.0,0.125427,"PFS and OS did not differ between two arms (LV vs V; median PFS, 16 vs 12 weeks, HR = 0.86, 95% CI 0.61-1.22; median OS, 15.0 vs 18.9 months, HR = 1.07, 95% CI 0.72-1.58).","[{'ForeName': 'Sung Hoon', 'Initials': 'SH', 'LastName': 'Sim', 'Affiliation': 'Center for Breast Cancer, Research Institute, National Cancer Center, Goyang, Korea.'}, {'ForeName': 'In Hae', 'Initials': 'IH', 'LastName': 'Park', 'Affiliation': 'Center for Breast Cancer, Research Institute, National Cancer Center, Goyang, Korea. parkih@ncc.re.kr.'}, {'ForeName': 'Kyung Hae', 'Initials': 'KH', 'LastName': 'Jung', 'Affiliation': 'Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sung-Bae', 'Initials': 'SB', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jin-Hee', 'Initials': 'JH', 'LastName': 'Ahn', 'Affiliation': 'Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Korea.'}, {'ForeName': 'Kyung-Hun', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Seoul National University Hospital, Cancer Research Institute, Seoul National University, College of Medicine, Seoul, Korea.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Seoul National University Hospital, Cancer Research Institute, Seoul National University, College of Medicine, Seoul, Korea.'}, {'ForeName': 'Young-Hyuck', 'Initials': 'YH', 'LastName': 'Im', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea.'}, {'ForeName': 'Yeon Hee', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea.'}, {'ForeName': 'Joohyuk', 'Initials': 'J', 'LastName': 'Sohn', 'Affiliation': 'Yonsei University, College of Medicine, Yonsei Cancer Center, Seoul, Korea.'}, {'ForeName': 'Yu Jung', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Division of Hematology and Medical Oncology, Department of Internal medicine, Seoul National University Bundang Hospital, Bundang, Korea.'}, {'ForeName': 'Suee', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Internal medicine, Dong-A University, College of Medicine, Busan, Korea.'}, {'ForeName': 'Hee-Jun', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Chung-Ang University, College of Medicine, Seoul, Korea.'}, {'ForeName': 'Yee Soo', 'Initials': 'YS', 'LastName': 'Chae', 'Affiliation': 'Kyungpook National University, College of Medicine, Daegu, Korea.'}, {'ForeName': 'Kyong Hwa', 'Initials': 'KH', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Division of Oncology/Hematology, Korea University, Seoul, Korea.'}, {'ForeName': 'Byung-Ho', 'Initials': 'BH', 'LastName': 'Nam', 'Affiliation': 'Biometric Research Branch, Division of Cancer Epidemiology and Prevention, Research Institute & Hospital, National Cancer Center, Goyang, Korea.'}, {'ForeName': 'Keun Seok', 'Initials': 'KS', 'LastName': 'Lee', 'Affiliation': 'Center for Breast Cancer, Research Institute, National Cancer Center, Goyang, Korea.'}, {'ForeName': 'Jungsil', 'Initials': 'J', 'LastName': 'Ro', 'Affiliation': 'Center for Breast Cancer, Research Institute, National Cancer Center, Goyang, Korea. jungsro@ncc.re.kr.'}]",British journal of cancer,['10.1038/s41416-019-0618-z']
3551,30776393,An examination of the moderating effects of neurophysiology on treatment outcomes from cognitive training in schizophrenia-spectrum disorders.,"BACKGROUND


Impairments in neurocognition and community functioning are core features of schizophrenia and cognitive training techniques have been developed with the aim of improving these impairments. While cognitive training has produced reliable improvements in neurocognition and functioning, little is known about factors that moderate treatment response. Electroencephalographic (EEG) measures provide a neurophysiological indicator of cognitive functions that may moderate treatment outcomes from cognitive training.
METHODS


Data from a clinical trial comparing two cognitive training approaches in schizophrenia-spectrum disorders were utilized in the current report. Cluster analysis was conducted to identify participant clusters based on baseline P300, mismatch negativity (MMN), and theta power during an n-back task, and the EEG measures were also examined as continuous predictors of treatment response.
RESULTS


Three clusters were identified based on the baseline EEG variables; however, there were no significant differences in treatment response across the three clusters. Higher P300 amplitude and theta power during the n-back at baseline were significantly associated with greater improvements in a cognitive composite score post-treatment. None of the EEG measures were significantly associated with treatment outcomes in specific cognitive domains or community functioning. Change in EEG measures from baseline to post-treatment was not significantly associated with durability of cognitive or functional change at 12-week follow-up.
CONCLUSIONS


Clusters derived from the EEG measures were not significantly associated with either neurocognitive or functional outcomes. P300 and n-back theta power may be associated with learning-related processes, which are important for acquisition and retention of skills during cognitive training programs. Future research should aim to identify at an individual level who is likely to respond to specific forms of cognitive enhancement.",2020,Higher P300 amplitude and theta power during the n-back at baseline were significantly associated with greater improvements in a cognitive composite score post-treatment.,['schizophrenia-spectrum disorders'],"['neurophysiology', 'cognitive training approaches', 'Electroencephalographic (EEG', 'cognitive training']","['durability of cognitive or functional change', 'cognitive composite score', 'baseline P300, mismatch negativity (MMN), and theta power during an n-back task, and the EEG measures', 'Change in EEG measures', 'Higher P300 amplitude and theta power', 'specific cognitive domains or community functioning']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0027901', 'cui_str': 'Neurophysiology'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0013819', 'cui_str': 'EEG'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444781', 'cui_str': 'P300 (P3) (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0009462', 'cui_str': 'Community'}]",3.0,0.04658,Higher P300 amplitude and theta power during the n-back at baseline were significantly associated with greater improvements in a cognitive composite score post-treatment.,"[{'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Best', 'Affiliation': ""Department of Psychology, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Milanovic', 'Affiliation': ""Department of Psychology, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Shamblaw', 'Affiliation': ""Department of Psychology, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Abi', 'Initials': 'A', 'LastName': 'Muere', 'Affiliation': ""Department of Psychology, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Lambe', 'Affiliation': ""Department of Psychology, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Irene K', 'Initials': 'IK', 'LastName': 'Hong', 'Affiliation': ""Department of Psychology, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Mashal K', 'Initials': 'MK', 'LastName': 'Haque', 'Affiliation': ""Department of Psychology, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Bowie', 'Affiliation': ""Department of Psychology, Queen's University, Kingston, Ontario, Canada; Centre for Addiction and Mental Health, Toronto, Ontario, Canada. Electronic address: bowiec@queensu.ca.""}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2019.02.004']
3552,31707049,Effect of Zataria multiflora on serum cytokine levels and pulmonary function tests in sulfur mustard-induced lung disorders: A randomized double-blind clinical trial.,"ETHNOPHARMACOLOGICAL RELEVANCE


Zataria multiflora (Z. multiflora) belongs to the Lamiaceae family and has several traditional uses owing to its antiseptic, aesthetic, antispasmodic, analgesic, and antidiarrheal properties.
AIM OF THE STUDY


We aimed to investigate the effect of Z. multiflora on serum cytokine levels and pulmonary function tests (PFT) in patients exposed to sulfur mustard (SM) for a long term (27-30 years).
MATERIALS AND METHODS


Thirty-five patients were randomly assigned to the placebo group (P) and two experimental groups treated with Z. multiflora extracts, i.e., 5 and 10 mg/kg/day (Z5 and Z10). Serum levels of cytokines including IL (2, 4, 6, 8, and 10) and IFN-γ as well as PFT indices such as maximum mid-expiratory flow (MMEF) and maximum expiratory flow at 25, 50, and 75% of vital capacity (VC) (MEF25, 50, and 75) were assessed at the beginning (phase 0) and at the end of 4 and 8 weeks (phases I and II, respectively) after starting the treatment.
RESULTS


Serum levels of IL-2, IL-6, and IL-8 were significantly decreased, while serum levels of IL-10 and IFN-γ were significantly increased in the Z5 and Z10 treatment groups in phases I and II as compared to those in phase 0 (p < 0.05 to p < 0.001). MMEF and MEF25, 50, and 75 values were significantly increased in the Z5 group in phase II and in the Z10 group in phases I and II compared to those in phase 0 (p < 0.05 to p < 0.001). The percent change in serum cytokine levels and the change in MEF25, 50, and 75 during the two-month treatment period were significantly higher in the treatment groups than in the placebo group.
CONCLUSIONS


Two months of treatment with Z. multiflora reduced inflammation, while it enhanced anti-inflammatory cytokines and improved PFT indices in SM-exposed patients.",2020,"MMEF and MEF25, 50, and 75 values were significantly increased in the Z5 group in phase II and in the Z10 group in phases","['Thirty-five patients', 'patients exposed to sulfur mustard (SM) for a long term (27-30 years', 'sulfur mustard-induced lung disorders']","['placebo', 'Zataria multiflora']","['serum cytokine levels and pulmonary function tests (PFT', 'vital capacity (VC) (MEF25, 50, and 75', 'serum cytokine levels and pulmonary function tests', 'serum levels of IL-10 and IFN-γ', 'enhanced anti-inflammatory cytokines and improved PFT indices', 'Serum levels of cytokines including IL (2, 4, 6, 8, and 10) and IFN-γ as well as PFT indices such as maximum mid-expiratory flow (MMEF) and maximum expiratory flow', 'serum cytokine levels', 'Serum levels of IL-2, IL-6, and IL-8']","[{'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0026874', 'cui_str': 'Yperite'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0024115', 'cui_str': 'Pulmonary Diseases'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test (procedure)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0021756', 'cui_str': 'TCGF'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}]",35.0,0.0586169,"MMEF and MEF25, 50, and 75 values were significantly increased in the Z5 group in phase II and in the Z10 group in phases","[{'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Khazdair', 'Affiliation': 'Cardiovascular Diseases Research Center, Birjand University of Medical Sciences, Birjand, Iran; Pharmaceutical Research Center and Department of Physiology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: m.khazdair@yahoo.com.'}, {'ForeName': 'Vahideh', 'Initials': 'V', 'LastName': 'Ghorani', 'Affiliation': 'Department of Physiology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: ghoranisv921@mums.ac.ir.'}, {'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Alavinezhad', 'Affiliation': 'Department of Physiology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: alavina901@mums.ac.ir.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Boskabady', 'Affiliation': 'Department of Physiology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran; Neurogenic Inflammation Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: boskabadymh@mums.ac.ir.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2019.112325']
3553,30516393,Perioperative Safety in Patient Under Oral Anticoagulation During Holmium Laser Enucleation of the Prostate.,"INTRODUCTION AND OBJECTIVES


To evaluate the safety of holmium laser enucleation of the prostate (HoLEP) in patients on oral anticoagulation (OA) with respect to intra- and postoperative bleeding complications.
METHODS


Between January 2013 and October 2016, 2178 patients were included in this study, of whom 94 received direct oral anticoagulants (DOACs) and 151 received vitamin K antagonists (VKAs) before HoLEP. All patients either ceased OA (DOACs) or were bridged subtherapeutically (VKAs, international normalized ratio <2) during surgery. These patients were compared to a sample size of 1933 nonanticoagulated patients.
RESULTS


A significant longer postoperative stay was noted for the patients on DOACs (5.2 [4-6] days) and VKAs (5.3 [4-5] days) compared to the control group (4.5 [4-4] days). The mean drop in hemoglobin was significantly higher in the VKA group compared to the DOAC and control group. There was a significantly higher rate of postoperative bladder tamponades/secondary coagulation in patients on OA with 6 (7.9%)/3 (3.9%) patients in the DOAC group, 10 (7.4%)/6 (4.4%) patients in the VKA group compared to 37 (2.2%)/21 (2.1%) patients in the control group, respectively (p < 0.001). Eight patients required blood transfusions with a distribution of 1 (1.3%), 3 (2.2%), and 4 (0.2%) patients in the DOAC, VKA, and control group, respectively (p < 0.001).
CONCLUSIONS


Our findings indicate that bridged patients who's DOACs and VKAs were ceased before HoLEP are at higher risk of intra- and postoperative bleeding complications. Nonetheless, HoLEP appears to be a safe and effective procedure in those patients.",2019,The mean drop in hemoglobin was significantly higher in the VKA group compared to the DOAC and control group.,"['patients on oral anticoagulation (OA) with respect to intra- and postoperative bleeding complications', 'Patient Under Oral Anticoagulation', 'Between January 2013 and October 2016, 2178 patients were included in this study, of whom 94 received', '1933 nonanticoagulated patients']","['VKA', 'direct oral anticoagulants (DOACs) and 151 received vitamin K antagonists (VKAs) before HoLEP', 'HoLEP', 'holmium laser enucleation of the prostate (HoLEP', 'Holmium Laser Enucleation of the Prostate']","['rate of postoperative bladder tamponades/secondary coagulation', 'Perioperative Safety', 'mean drop in hemoglobin', 'blood transfusions', 'postoperative stay']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C3653316', 'cui_str': 'Vitamin K antagonists'}, {'cui': 'C1955839', 'cui_str': 'Holmium Lasers'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1328289', 'cui_str': 'Bladder tamponade'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}]",2178.0,0.027051,The mean drop in hemoglobin was significantly higher in the VKA group compared to the DOAC and control group.,"[{'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Becker', 'Affiliation': '1 Department of Urology, Asklepios Hospital Barmbek, Hamburg, Germany.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Netsch', 'Affiliation': '1 Department of Urology, Asklepios Hospital Barmbek, Hamburg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Hansen', 'Affiliation': '2 Department of Urology, Auguste Viktoria Hospital, Berlin, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Böhme', 'Affiliation': '2 Department of Urology, Auguste Viktoria Hospital, Berlin, Germany.'}, {'ForeName': 'Andreas J', 'Initials': 'AJ', 'LastName': 'Gross', 'Affiliation': '1 Department of Urology, Asklepios Hospital Barmbek, Hamburg, Germany.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Zacharias', 'Affiliation': '2 Department of Urology, Auguste Viktoria Hospital, Berlin, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Lehrich', 'Affiliation': '2 Department of Urology, Auguste Viktoria Hospital, Berlin, Germany.'}]",Journal of endourology,['10.1089/end.2018.0693']
3554,32056539,"Effects of saffron on sleep quality in healthy adults with self-reported poor sleep: a randomized, double-blind, placebo-controlled trial.","STUDY OBJECTIVES


Herbal medicines are frequently used by adults with sleep difficulties. However, evidence of their efficacy is limited. Therefore, the goal of this study was to examine the sleep-enhancing effects of a standardized saffron extract (affron).
METHODS


This was a 28-day, parallel-group, double-blind, randomized controlled trial. Sixty-three healthy adults aged 18-70 with self-reported sleep problems were recruited and randomized to receive either saffron extract (affron; 14 mg twice daily) or a placebo. Outcome measures included the Insomnia Severity Index (ISI; primary outcome measure) collected at baseline and days 7, 14, 21, and 28 and the Restorative Sleep Questionnaire (RSQ) and the Pittsburgh Sleep Diary (PSD) collected on days -1, 0, 3, 7, 14, 27, and 28.
RESULTS


Based on data collected from 55 participants, saffron was associated with greater improvements in ISI total score (P = .017), RSQ total score (P = .029), and PSD sleep quality ratings (P = .014) than the placebo. Saffron intake was well tolerated with no reported adverse effects.
CONCLUSIONS


Saffron intake was associated with improvements in sleep quality in adults with self-reported sleep complaints. Further studies using larger samples sizes, treatment periods, objective outcome measures, and volunteers with varying demographic and psychographic characteristics are required to replicate and extend these findings.
CLINICAL TRIAL REGISTRATION


Registry: Australian New Zealand Clinical Trials Registry; Name: Effects of Saffron on Sleep Quality in Healthy Adults with Self-Reported Unsatisfactory Sleep; URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377781; Identifier: ACTRN12619000863134.",2020,", saffron was associated with greater improvements in ISI total score (p=.017), RSQ total score (p=.029), and PSD sleep quality ratings (p=.014) than the placebo.","['adults with self-reported sleep complaints', 'Healthy Adults', 'adults with sleep difficulties', '55 participants', 'Sixty-three healthy adults aged 18 to 70 with self-reported sleep problems']","['Saffron', 'placebo', 'standardised saffron extract (affron', 'saffron extract', 'Placebo']","['RSQ total score (p=.029), and PSD sleep quality ratings', 'adverse effects', 'Sleep Quality', 'Insomnia Severity Index (ISI) (primary outcome measure) collected at baseline, days 7, 14, 21, and 28; Restorative Sleep Questionnaire (RSQ) and Pittsburgh Sleep Diary (PSD', 'ISI total score', 'sleep quality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}]","[{'cui': 'C2348128', 'cui_str': 'Saffron'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3696061', 'cui_str': 'Saffron Extract'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0376660', 'cui_str': 'Diary'}]",63.0,0.705588,", saffron was associated with greater improvements in ISI total score (p=.017), RSQ total score (p=.029), and PSD sleep quality ratings (p=.014) than the placebo.","[{'ForeName': 'Adrian L', 'Initials': 'AL', 'LastName': 'Lopresti', 'Affiliation': 'College of Science, Health, Engineering, and Education, Murdoch University, Perth, Western Australia, Australia.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Smith', 'Affiliation': 'College of Science, Health, Engineering, and Education, Murdoch University, Perth, Western Australia, Australia.'}, {'ForeName': 'Alexandra P', 'Initials': 'AP', 'LastName': 'Metse', 'Affiliation': 'College of Science, Health, Engineering, and Education, Murdoch University, Perth, Western Australia, Australia.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Drummond', 'Affiliation': 'College of Science, Health, Engineering, and Education, Murdoch University, Perth, Western Australia, Australia.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8376']
3555,31433259,A Smartphone App to Facilitate Remote Patient-Provider Communication in Hearing Health Care: Usability and Effect on Hearing Aid Outcomes.,"Background:   Patients often need multiple fine-tuning appointments with their hearing health care provider to achieve satisfactory hearing aid outcomes. A smartphone app that enables patients to remotely request and receive new hearing aid settings could improve hearing health care access and efficiency.   Introduction:   We assessed the usability of ReSound Assist™, (ReSound America, Bloomington, MN) the remote communication feature of a hearing aid app, and investigated whether hearing aid outcomes are influenced by app-based versus in-person patient-provider communication.   Materials and Methods:   Thirty adults were fit bilaterally with hearing aids and randomized to intervention and control groups. During a 6-week field trial, participants reported hearing aid problems via ReSound Assist (intervention) or at a scheduled face-to-face follow-up appointment (control). Usability of ReSound Assist was assessed with a questionnaire and interview. Hearing aid performance, benefit, satisfaction, and daily usage were compared for both groups.   Results:   ReSound Assist was rated as highly usable. Participants identified specific aspects of effectiveness and efficiency that could be improved. Similar problems were reported by intervention and control participants regardless of communication mode (app-based vs. in-person). However, almost half the requests received via ReSound Assist were for problems that required advice from the provider or physical modifications to the hearing aids rather than fine-tuning, highlighting the continued importance of in-person hearing health care. There was no significant difference in hearing aid outcomes between intervention and control participants.   Conclusions:   Apps enabling remote patient-provider communication are a viable method for hearing aid users to seek and receive help with hearing aid problems that can be addressed through fine-tuning.",2020,A smartphone app that enables patients to remotely request and receive new hearing aid settings could improve hearing health care access and efficiency.   ,"['participants reported hearing aid problems via ReSound Assist (intervention) or at a scheduled face-to-face follow-up appointment (control', 'Thirty adults']",[],"['Hearing aid performance, benefit, satisfaction, and daily usage', 'hearing aid outcomes']","[{'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1272118', 'cui_str': 'Hearing aid problem'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0018768', 'cui_str': 'Hearing Aids'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}]",30.0,0.033924,A smartphone app that enables patients to remotely request and receive new hearing aid settings could improve hearing health care access and efficiency.   ,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Convery', 'Affiliation': 'National Acoustic Laboratories, Sydney, Australia.'}, {'ForeName': 'Gitte', 'Initials': 'G', 'LastName': 'Keidser', 'Affiliation': 'National Acoustic Laboratories, Sydney, Australia.'}, {'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'McLelland', 'Affiliation': 'National Acoustic Laboratories, Sydney, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Groth', 'Affiliation': 'GN Hearing, Glenview, Illinois, USA.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2019.0109']
3556,31519441,The Effect of Extended Continuous Positive Airway Pressure on Changes in Lung Volumes in Stable Premature Infants: A Randomized Controlled Trial.,"OBJECTIVE


To compare changes in lung volumes, as measured by functional residual capacity (FRC), through to discharge in stable infants randomized to 2 weeks of extended continuous positive airway pressure CPAP (eCPAP) vs CPAP discontinuation (dCPAP).
STUDY DESIGN


Infants born at ≤32 weeks of gestation requiring ≥24 hours of CPAP were randomized to 2 weeks of eCPAP vs dCPAP when meeting CPAP stability criteria. FRC was measured with the nitrogen washout technique. Infants were stratified by gestational age (<28 and ≥ 28 weeks) and twin gestation. A linear mixed-effects model was used to evaluate the change in FRC between the 2 groups. Data were analyzed blinded to treatment group allocation.
RESULTS


Fifty infants were randomized with 6 excluded, for a total of 44 infants. Baseline characteristics were similar in the 2 groups. The infants randomized to eCPAP vs dCPAP had a greater increase in FRC from randomization through 2 weeks (12.6 mL vs 6.4 mL; adjusted 95% CI, 0.78-13.47; P = .03) and from randomization through discharge (27.2 mL vs 17.1 mL; adjusted 95% CI, 2.61-17.59; P = .01).
CONCLUSIONS


Premature infants randomized to eCPAP had a significantly greater increase in FRC through discharge compared with those randomized to dCPAP. An increased change in FRC may lead to improved respiratory health.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT02249143.",2020,"CONCLUSIONS


Premature infants randomized to eCPAP had a significantly greater increase in FRC through discharge compared with those randomized to dCPAP.","['Infants were stratified by gestational age (<28 and\xa0≥\xa028\xa0weeks) and twin gestation', 'Fifty infants were randomized with 6 excluded, for a total of 44 infants', 'Stable Premature Infants', 'Infants born at ≤32\xa0weeks of gestation requiring ≥24\xa0hours of CPAP']","['extended continuous positive airway pressure CPAP (eCPAP) vs CPAP discontinuation (dCPAP', 'eCPAP vs dCPAP', 'eCPAP', 'Extended Continuous Positive Airway Pressure']","['Lung Volumes', 'FRC', 'FRC through discharge']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}]","[{'cui': 'C0231953', 'cui_str': 'Lung volume, function (observable entity)'}, {'cui': 'C0016815', 'cui_str': 'Functional Residual Capacity'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]",50.0,0.394834,"CONCLUSIONS


Premature infants randomized to eCPAP had a significantly greater increase in FRC through discharge compared with those randomized to dCPAP.","[{'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Lam', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Schilling', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Scottoline', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Platteau', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Meike', 'Initials': 'M', 'LastName': 'Niederhausen', 'Affiliation': 'Biostatistics and Design Program, Oregon Health & Science University-Portland State University School of Public Health, Portland, OR.'}, {'ForeName': 'Kelli C', 'Initials': 'KC', 'LastName': 'Lund', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Schelonka', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Kelvin D', 'Initials': 'KD', 'LastName': 'MacDonald', 'Affiliation': 'Division of Pediatric Pulmonology, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Cindy T', 'Initials': 'CT', 'LastName': 'McEvoy', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Oregon Health & Science University, Portland, OR. Electronic address: mcevoyc@ohsu.edu.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.07.074']
3557,31665385,"Daily Supplementation With Egg, Cow Milk, and Multiple Micronutrients Increases Linear Growth of Young Children with Short Stature.","BACKGROUND


Childhood stunting is the most prevalent public health nutrition problem in low- and middle-income countries.
OBJECTIVE


This study aimed to determine whether daily supplementation in 12-18-mo-old undernourished Bangladeshi children with egg, cow milk, and multiple micronutrients improves linear growth.
METHODS


In the Bangladesh Environmental Enteric Dysfunction (BEED) study, a community-based intervention study, 12-18-mo-old children with length-for-age z score (LAZ) <1 were supplemented daily with an egg and 150 mL of milk for 90 feeding days, and 1 sachet of multiple micronutrient powder was provided daily for 60 feeding days. The change in LAZ over this period was compared with that in children of the same age and same baseline LAZ who were enrolled in the recently completed Etiology, Risk Factors, and Interactions of Enteric Infections and Malnutrition and the Consequences for Child Health (MAL-ED) Dhaka birth cohort study conducted in the same community where no nutrition intervention was provided. Difference-in-difference (DID) analysis was done and the effect size was adjusted for other possible covariates using a generalized estimating equation in a regression model.
RESULTS


A total of 472 children with LAZ <1 completed the intervention and data were available for 174 children in the comparison group. Compared with the comparison group, adjusted DID analysis revealed a change in LAZ in the intervention group of +0.23 (95% CI: 0.18, 0.29; P < 0.05). In a subgroup analysis, the changes were +0.27 (95% CI: 0.18, 0.35; P < 0.05) in stunted (LAZ <2) children and +0.19 (95% CI: 0.12, 0.27; P < 0.05) in children at risk of stunting (LAZ -1 to -2). No allergic reactions or other adverse events related to milk and egg consumption were observed.
CONCLUSIONS


Daily directly observed milk, egg, and multiple micronutrient supplementation may improve linear growth of stunted children. A randomized controlled trial with longer duration of supplementation coupled with an additional intervention aimed at reducing pathogen burden is warranted to confirm these results. This trial was registered at clinicaltrials.gov as NCT02812615.",2020,A total of 472 children with LAZ <1 completed the intervention and data were available for 174 children in the comparison group.,"['12-18-mo-old undernourished Bangladeshi children with egg, cow milk, and multiple micronutrients improves linear growth', '12-18-mo-old children with length-for-age z score (LAZ) <1 were', 'Young Children with Short Stature', '472 children with LAZ <1 completed the intervention and data were available for 174 children in the comparison group']","['Daily Supplementation With Egg, Cow Milk, and Multiple Micronutrients', 'daily supplementation', 'LAZ', 'supplemented daily with an egg and 150\xa0mL of milk for 90 feeding days, and 1 sachet of multiple micronutrient powder']",['change in LAZ'],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0422784', 'cui_str': 'Bangladeshi'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0029974', 'cui_str': 'Egg, Unfertilized'}, {'cui': 'C0349374', 'cui_str': ""Cow's milk (substance)""}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0013336', 'cui_str': 'Nanism'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0029974', 'cui_str': 'Egg, Unfertilized'}, {'cui': 'C0349374', 'cui_str': ""Cow's milk (substance)""}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4319662', 'cui_str': 'Sachet'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}]",472.0,0.290079,A total of 472 children with LAZ <1 completed the intervention and data were available for 174 children in the comparison group.,"[{'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Mahfuz', 'Affiliation': 'icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Mohammed Ashraful', 'Initials': 'MA', 'LastName': 'Alam', 'Affiliation': 'icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Subhasish', 'Initials': 'S', 'LastName': 'Das', 'Affiliation': 'icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Shah Mohammad', 'Initials': 'SM', 'LastName': 'Fahim', 'Affiliation': 'icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Md Shabab', 'Initials': 'MS', 'LastName': 'Hossain', 'Affiliation': 'icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Petri', 'Affiliation': 'University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ashorn', 'Affiliation': 'Faculty of Medicine and Life Sciences, University of Tampere, Finland.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Ashorn', 'Affiliation': 'Faculty of Medicine and Life Sciences, University of Tampere, Finland.'}, {'ForeName': 'Tahmeed', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'icddr,b, Dhaka, Bangladesh.'}]",The Journal of nutrition,['10.1093/jn/nxz253']
3558,31149930,Prolonged Perioperative Use of Pregabalin and Ketamine to Prevent Persistent Pain after Cardiac Surgery.,"BACKGROUND


Persistent postsurgical pain is common and affects quality of life. The hypothesis was that use of pregabalin and ketamine would prevent persistent pain after cardiac surgery.
METHODS


This randomized, double-blind, placebo-controlled trial was undertaken at two cardiac surgery centers in the United Kingdom. Adults without chronic pain and undergoing any elective cardiac surgery patients via sternotomy were randomly assigned to receive either usual care, pregabalin (150 mg preoperatively and twice daily for 14 postoperative days) alone, or pregabalin in combination with a 48-h postoperative infusion of intravenous ketamine at 0.1 mg · kg · h. The primary endpoints were prevalence of clinically significant pain at 3 and 6 months after surgery, defined as a pain score on the numeric rating scale of 4 or higher (out of 10) after a functional assessment of three maximal coughs. The secondary outcomes included acute pain, opioid use, and safety measures, as well as long-term neuropathic pain, analgesic requirement, and quality of life.
RESULTS


In total, 150 patients were randomized, with 17 withdrawals from treatment and 2 losses to follow-up but with data analyzed for all participants on an intention-to-treat basis. The prevalence of pain was lower at 3 postoperative months for pregabalin alone (6% [3 of 50]) and in combination with ketamine (2% [1 of 50]) compared to the control group (34% [17 of 50]; odds ratio = 0.126 [0.022 to 0.5], P = 0.0008; and 0.041 [0.0009 to 0.28], P < 0.0001, respectively) and at 6 months for pregabalin alone (6% [3 of 50]) and in combination with ketamine 0% (0 of 5) compared to the control group (28% [14 of 50]; odds ratio = 0.167 [0.029 to 0.7], P = 0.006; and 0.000 [0 to 0.24], P < 0.0001). Diplopia was more common in both active arms.
CONCLUSIONS


Preoperative administration of 150 mg of pregabalin and postoperative continuation twice daily for 14 days significantly lowered the prevalence of persistent pain after cardiac surgery.",2019,"The prevalence of pain was lower at 3 postoperative months for pregabalin alone (6% [3 of 50]) and in combination with ketamine (2% [1 of 50]) compared to the control group (34% [17 of 50]; odds ratio = 0.126 [0.022 to 0.5], P = 0.0008; and 0.041 [0.0009 to 0.28], P < 0.0001, respectively) and at 6 months for pregabalin alone (6% [3 of 50]) and in combination with ketamine 0% (0 of 5) compared to the control group (28% [14 of 50]; odds ratio = 0.167 [0.029 to 0.7], P = 0.006; and 0.000 [0 to 0.24], P < 0.0001).","['Adults without chronic pain and undergoing any elective cardiac surgery patients via sternotomy', '150 patients', 'two cardiac surgery centers in the United Kingdom']","['pregabalin and ketamine', 'ketamine', 'placebo', 'pregabalin', 'usual care, pregabalin (150\u2009mg preoperatively and twice daily for 14 postoperative days) alone, or pregabalin in combination with a 48-h postoperative infusion of intravenous ketamine', 'Pregabalin and Ketamine']","['pain score on the numeric rating scale', 'chronic postoperative pain', 'prevalence of persistent pain', 'prevalence of pain', 'persistent pain', 'acute pain, opioid use, and safety measures, as well as long-term neuropathic pain, analgesic requirement, and quality of life', 'prevalence of clinically significant pain']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0185792', 'cui_str': 'Sternotomy'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}]","[{'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0222045'}, {'cui': 'C2074900', 'cui_str': 'Chronic postoperative pain (finding)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184567', 'cui_str': 'Acute Pain'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0027796', 'cui_str': 'Neurodynia'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0034380'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]",150.0,0.329842,"The prevalence of pain was lower at 3 postoperative months for pregabalin alone (6% [3 of 50]) and in combination with ketamine (2% [1 of 50]) compared to the control group (34% [17 of 50]; odds ratio = 0.126 [0.022 to 0.5], P = 0.0008; and 0.041 [0.0009 to 0.28], P < 0.0001, respectively) and at 6 months for pregabalin alone (6% [3 of 50]) and in combination with ketamine 0% (0 of 5) compared to the control group (28% [14 of 50]; odds ratio = 0.167 [0.029 to 0.7], P = 0.006; and 0.000 [0 to 0.24], P < 0.0001).","[{'ForeName': 'Sibtain', 'Initials': 'S', 'LastName': 'Anwar', 'Affiliation': ""From the Department of Perioperative Medicine, Barts Heart Centre, London, United Kingdom (S.A.) National Institutes of Health Research Biomedical Research Centre at Barts, London, United Kingdom (S.A., J.C.) Pain and Anaesthesia Research Centre, St. Bartholomew's Hospital, London, United Kingdom (S.A., J.R., C.S., R.L.).""}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Cooper', 'Affiliation': ''}, {'ForeName': 'Junia', 'Initials': 'J', 'LastName': 'Rahman', 'Affiliation': ''}, {'ForeName': 'Chhaya', 'Initials': 'C', 'LastName': 'Sharma', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Langford', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000002751']
3559,31838405,Patient-reported outcomes from FLAURA: Osimertinib versus erlotinib or gefitinib in patients with EGFR-mutated advanced non-small-cell lung cancer.,"BACKGROUND


In the FLAURA trial, osimertinib demonstrated superior progression-free survival and a favorable toxicity profile to erlotinib or gefitinib as initial therapy in patients with EGFR-mutated advanced non-small-cell lung cancer. Patient-reported outcomes from FLAURA are discussed here.
METHODS


Patients (N = 556) completed the EORTC QLQ-LC13 weekly for 6 weeks, then every 3 weeks, and the QLQ-C30 every 6 weeks. Prespecified key symptoms were cough, dyspnea, chest pain, appetite loss, and fatigue. Score changes from baseline to randomized treatment discontinuation were assessed using a mixed-effects model. A ≥10-point change was considered clinically relevant. Odds of improvement and time to deterioration were investigated. QLQ-C30 functioning scores were assessed post hoc.
RESULTS


Questionnaire completion rates were >70% at most time points. Baseline mean scores were similar in the osimertinib and erlotinib/gefitinib arms. Scores improved in both arms, but none reached clinical relevance at 5% significance level. A statistically significant difference favoring osimertinib for chest pain was not clinically relevant (-6.84 vs -3.88; p = 0.021). Odds of improvement and time to deterioration were similar between treatments. In post hoc analyses, improvements favored osimertinib for emotional functioning (8.79 vs 4.91; p = 0.004) and social functioning (7.66 vs 1.74; p < 0.001). Cognitive functioning remained stable with osimertinib but deteriorated with erlotinib/gefitinib (0.03 vs -3.91; p = 0.005).
CONCLUSIONS


Key symptoms improved from baseline in both treatment arms in FLAURA. Key symptom improvements that were both statistically significant and clinically relevant were not observed in favor of either treatment arm.
CLINICAL TRIAL REGISTRATION


NCT02296125.",2020,"In post hoc analyses, improvements favored osimertinib for emotional functioning (8.79 vs 4.91; p = 0.004) and social functioning (7.66 vs 1.74; p < 0.001).","['Patients (N\xa0=\xa0556) completed the', 'patients with EGFR-mutated advanced non-small-cell lung cancer']","['FLAURA', 'EORTC QLQ-LC13', 'Osimertinib versus erlotinib or gefitinib', 'erlotinib/gefitinib', 'erlotinib or gefitinib']","['osimertinib for emotional functioning', 'Questionnaire completion rates', 'Cognitive functioning', 'chest pain', 'Baseline mean scores', 'cough, dyspnea, chest pain, appetite loss, and fatigue', 'social functioning', 'time to deterioration', 'QLQ-C30 functioning scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517811', 'cui_str': 'Five hundred and fifty-six'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C4058811', 'cui_str': 'osimertinib'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}]","[{'cui': 'C4058811', 'cui_str': 'osimertinib'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0031843', 'cui_str': 'function'}]",556.0,0.200839,"In post hoc analyses, improvements favored osimertinib for emotional functioning (8.79 vs 4.91; p = 0.004) and social functioning (7.66 vs 1.74; p < 0.001).","[{'ForeName': 'Natasha B', 'Initials': 'NB', 'LastName': 'Leighl', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Karaseva', 'Affiliation': 'City Clinical Oncology Dispensary, St. Petersburg, Russia.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Medical Oncology, Kindai University Faculty of Medicine, Osakasayama, Japan.'}, {'ForeName': 'Byoung-Chul', 'Initials': 'BC', 'LastName': 'Cho', 'Affiliation': 'Division of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jhanelle E', 'Initials': 'JE', 'LastName': 'Gray', 'Affiliation': 'Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Hovey', 'Affiliation': 'PHASTAR, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Walding', 'Affiliation': 'AstraZeneca R&D, Cambridge, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rydén', 'Affiliation': 'AstraZeneca Gothenburg, Mölndal, Sweden.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Novello', 'Affiliation': 'Department of Oncology, University of Turin, Azienda Ospedaliero-Universitaria San Luigi Gonzaga, Turin, Italy. Electronic address: silvia.novello@unito.it.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.11.006']
3560,31112383,Early Neuromuscular Blockade in the Acute Respiratory Distress Syndrome.,"BACKGROUND


The benefits of early continuous neuromuscular blockade in patients with acute respiratory distress syndrome (ARDS) who are receiving mechanical ventilation remain unclear.
METHODS


We randomly assigned patients with moderate-to-severe ARDS (defined by a ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen of <150 mm Hg with a positive end-expiratory pressure [PEEP] of ≥8 cm of water) to a 48-hour continuous infusion of cisatracurium with concomitant deep sedation (intervention group) or to a usual-care approach without routine neuromuscular blockade and with lighter sedation targets (control group). The same mechanical-ventilation strategies were used in both groups, including a strategy involving a high PEEP. The primary end point was in-hospital death from any cause at 90 days.
RESULTS


The trial was stopped at the second interim analysis for futility. We enrolled 1006 patients early after the onset of moderate-to-severe ARDS (median, 7.6 hours after onset). During the first 48 hours after randomization, 488 of the 501 patients (97.4%) in the intervention group started a continuous infusion of cisatracurium (median duration of infusion, 47.8 hours; median dose, 1807 mg), and 86 of the 505 patients (17.0%) in the control group received a neuromuscular blocking agent (median dose, 38 mg). At 90 days, 213 patients (42.5%) in the intervention group and 216 (42.8%) in the control group had died before hospital discharge (between-group difference, -0.3 percentage points; 95% confidence interval, -6.4 to 5.9; P = 0.93). While in the hospital, patients in the intervention group were less physically active and had more adverse cardiovascular events than patients in the control group. There were no consistent between-group differences in end points assessed at 3, 6, and 12 months.
CONCLUSIONS


Among patients with moderate-to-severe ARDS who were treated with a strategy involving a high PEEP, there was no significant difference in mortality at 90 days between patients who received an early and continuous cisatracurium infusion and those who were treated with a usual-care approach with lighter sedation targets. (Funded by the National Heart, Lung, and Blood Institute; ROSE ClinicalTrials.gov number, NCT02509078.).",2019,"While in the hospital, patients in the intervention group were less physically active and had more adverse cardiovascular events than patients in the control group.","['Acute Respiratory Distress Syndrome', 'patients with moderate-to-severe ARDS', 'patients with acute respiratory distress syndrome (ARDS', 'We randomly assigned patients with moderate-to-severe ARDS (defined by a ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen of <150 mm Hg with a positive end-expiratory pressure [PEEP] of ≥8 cm of water) to a', '1006 patients early after the onset of moderate-to-severe ARDS (median, 7.6 hours after onset']","['neuromuscular blocking agent', '48-hour continuous infusion of cisatracurium with concomitant deep sedation (intervention group) or to a usual-care approach without routine neuromuscular blockade and with lighter sedation targets (control group']","['mortality', 'hospital death', 'died before hospital discharge', 'adverse cardiovascular events']","[{'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C3494516', 'cui_str': 'Positive end expiratory pressure (observable entity)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}]","[{'cui': 'C0027866', 'cui_str': 'Neuromuscular Blockers'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion (qualifier value)'}, {'cui': 'C1096766', 'cui_str': 'Cisatracurium'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C1956064', 'cui_str': 'Deep Sedation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0235062', 'cui_str': 'Neuromuscular Block'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",1006.0,0.269122,"While in the hospital, patients in the intervention group were less physically active and had more adverse cardiovascular events than patients in the control group.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Moss', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Departments of Medicine (M.M.) and Emergency Medicine (A.A.G.), University of Colorado School of Medicine, Aurora; the Departments of Critical Care Medicine (D.T.H., D.C.A.) and Emergency Medicine (D.M.Y.), University of Pittsburgh School of Medicine, Pittsburgh; the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Interdepartmental Division of Critical Care Medicine, Department of Medicine, University Health Network and Sinai Health System, University of Toronto, Toronto (N.D.F.); the Department of Medicine, Montefiore Hospital, New York (M.N.G.); the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (S.G., C.L.H.); the Biostatistics Center (D.H.), the Department of Medicine (B.T.T.), and the PETAL Network Clinical Coordinating Center (C.A.U.), Massachusetts General Hospital, the Department of Emergency Medicine, Division of Emergency Critical Care Medicine, Brigham and Women's Hospital (P.C.H.), and the Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center (D.T.) - all in Boston; the Department of Critical Care, Respiratory Institute, Cleveland Clinic, Cleveland (R.D.H.); the Department of Medicine, University of Michigan and Veterans Affairs Center for Clinical Research, Ann Arbor (T.J.I.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); and the Departments of Medicine and Anesthesia, University of California, San Francisco, San Francisco (K.D.L.).""}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Huang', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Departments of Medicine (M.M.) and Emergency Medicine (A.A.G.), University of Colorado School of Medicine, Aurora; the Departments of Critical Care Medicine (D.T.H., D.C.A.) and Emergency Medicine (D.M.Y.), University of Pittsburgh School of Medicine, Pittsburgh; the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Interdepartmental Division of Critical Care Medicine, Department of Medicine, University Health Network and Sinai Health System, University of Toronto, Toronto (N.D.F.); the Department of Medicine, Montefiore Hospital, New York (M.N.G.); the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (S.G., C.L.H.); the Biostatistics Center (D.H.), the Department of Medicine (B.T.T.), and the PETAL Network Clinical Coordinating Center (C.A.U.), Massachusetts General Hospital, the Department of Emergency Medicine, Division of Emergency Critical Care Medicine, Brigham and Women's Hospital (P.C.H.), and the Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center (D.T.) - all in Boston; the Department of Critical Care, Respiratory Institute, Cleveland Clinic, Cleveland (R.D.H.); the Department of Medicine, University of Michigan and Veterans Affairs Center for Clinical Research, Ann Arbor (T.J.I.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); and the Departments of Medicine and Anesthesia, University of California, San Francisco, San Francisco (K.D.L.).""}, {'ForeName': 'Roy G', 'Initials': 'RG', 'LastName': 'Brower', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Departments of Medicine (M.M.) and Emergency Medicine (A.A.G.), University of Colorado School of Medicine, Aurora; the Departments of Critical Care Medicine (D.T.H., D.C.A.) and Emergency Medicine (D.M.Y.), University of Pittsburgh School of Medicine, Pittsburgh; the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Interdepartmental Division of Critical Care Medicine, Department of Medicine, University Health Network and Sinai Health System, University of Toronto, Toronto (N.D.F.); the Department of Medicine, Montefiore Hospital, New York (M.N.G.); the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (S.G., C.L.H.); the Biostatistics Center (D.H.), the Department of Medicine (B.T.T.), and the PETAL Network Clinical Coordinating Center (C.A.U.), Massachusetts General Hospital, the Department of Emergency Medicine, Division of Emergency Critical Care Medicine, Brigham and Women's Hospital (P.C.H.), and the Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center (D.T.) - all in Boston; the Department of Critical Care, Respiratory Institute, Cleveland Clinic, Cleveland (R.D.H.); the Department of Medicine, University of Michigan and Veterans Affairs Center for Clinical Research, Ann Arbor (T.J.I.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); and the Departments of Medicine and Anesthesia, University of California, San Francisco, San Francisco (K.D.L.).""}, {'ForeName': 'Niall D', 'Initials': 'ND', 'LastName': 'Ferguson', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Departments of Medicine (M.M.) and Emergency Medicine (A.A.G.), University of Colorado School of Medicine, Aurora; the Departments of Critical Care Medicine (D.T.H., D.C.A.) and Emergency Medicine (D.M.Y.), University of Pittsburgh School of Medicine, Pittsburgh; the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Interdepartmental Division of Critical Care Medicine, Department of Medicine, University Health Network and Sinai Health System, University of Toronto, Toronto (N.D.F.); the Department of Medicine, Montefiore Hospital, New York (M.N.G.); the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (S.G., C.L.H.); the Biostatistics Center (D.H.), the Department of Medicine (B.T.T.), and the PETAL Network Clinical Coordinating Center (C.A.U.), Massachusetts General Hospital, the Department of Emergency Medicine, Division of Emergency Critical Care Medicine, Brigham and Women's Hospital (P.C.H.), and the Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center (D.T.) - all in Boston; the Department of Critical Care, Respiratory Institute, Cleveland Clinic, Cleveland (R.D.H.); the Department of Medicine, University of Michigan and Veterans Affairs Center for Clinical Research, Ann Arbor (T.J.I.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); and the Departments of Medicine and Anesthesia, University of California, San Francisco, San Francisco (K.D.L.).""}, {'ForeName': 'Adit A', 'Initials': 'AA', 'LastName': 'Ginde', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Departments of Medicine (M.M.) and Emergency Medicine (A.A.G.), University of Colorado School of Medicine, Aurora; the Departments of Critical Care Medicine (D.T.H., D.C.A.) and Emergency Medicine (D.M.Y.), University of Pittsburgh School of Medicine, Pittsburgh; the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Interdepartmental Division of Critical Care Medicine, Department of Medicine, University Health Network and Sinai Health System, University of Toronto, Toronto (N.D.F.); the Department of Medicine, Montefiore Hospital, New York (M.N.G.); the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (S.G., C.L.H.); the Biostatistics Center (D.H.), the Department of Medicine (B.T.T.), and the PETAL Network Clinical Coordinating Center (C.A.U.), Massachusetts General Hospital, the Department of Emergency Medicine, Division of Emergency Critical Care Medicine, Brigham and Women's Hospital (P.C.H.), and the Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center (D.T.) - all in Boston; the Department of Critical Care, Respiratory Institute, Cleveland Clinic, Cleveland (R.D.H.); the Department of Medicine, University of Michigan and Veterans Affairs Center for Clinical Research, Ann Arbor (T.J.I.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); and the Departments of Medicine and Anesthesia, University of California, San Francisco, San Francisco (K.D.L.).""}, {'ForeName': 'M N', 'Initials': 'MN', 'LastName': 'Gong', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Departments of Medicine (M.M.) and Emergency Medicine (A.A.G.), University of Colorado School of Medicine, Aurora; the Departments of Critical Care Medicine (D.T.H., D.C.A.) and Emergency Medicine (D.M.Y.), University of Pittsburgh School of Medicine, Pittsburgh; the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Interdepartmental Division of Critical Care Medicine, Department of Medicine, University Health Network and Sinai Health System, University of Toronto, Toronto (N.D.F.); the Department of Medicine, Montefiore Hospital, New York (M.N.G.); the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (S.G., C.L.H.); the Biostatistics Center (D.H.), the Department of Medicine (B.T.T.), and the PETAL Network Clinical Coordinating Center (C.A.U.), Massachusetts General Hospital, the Department of Emergency Medicine, Division of Emergency Critical Care Medicine, Brigham and Women's Hospital (P.C.H.), and the Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center (D.T.) - all in Boston; the Department of Critical Care, Respiratory Institute, Cleveland Clinic, Cleveland (R.D.H.); the Department of Medicine, University of Michigan and Veterans Affairs Center for Clinical Research, Ann Arbor (T.J.I.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); and the Departments of Medicine and Anesthesia, University of California, San Francisco, San Francisco (K.D.L.).""}, {'ForeName': 'Colin K', 'Initials': 'CK', 'LastName': 'Grissom', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Departments of Medicine (M.M.) and Emergency Medicine (A.A.G.), University of Colorado School of Medicine, Aurora; the Departments of Critical Care Medicine (D.T.H., D.C.A.) and Emergency Medicine (D.M.Y.), University of Pittsburgh School of Medicine, Pittsburgh; the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Interdepartmental Division of Critical Care Medicine, Department of Medicine, University Health Network and Sinai Health System, University of Toronto, Toronto (N.D.F.); the Department of Medicine, Montefiore Hospital, New York (M.N.G.); the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (S.G., C.L.H.); the Biostatistics Center (D.H.), the Department of Medicine (B.T.T.), and the PETAL Network Clinical Coordinating Center (C.A.U.), Massachusetts General Hospital, the Department of Emergency Medicine, Division of Emergency Critical Care Medicine, Brigham and Women's Hospital (P.C.H.), and the Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center (D.T.) - all in Boston; the Department of Critical Care, Respiratory Institute, Cleveland Clinic, Cleveland (R.D.H.); the Department of Medicine, University of Michigan and Veterans Affairs Center for Clinical Research, Ann Arbor (T.J.I.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); and the Departments of Medicine and Anesthesia, University of California, San Francisco, San Francisco (K.D.L.).""}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Gundel', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Departments of Medicine (M.M.) and Emergency Medicine (A.A.G.), University of Colorado School of Medicine, Aurora; the Departments of Critical Care Medicine (D.T.H., D.C.A.) and Emergency Medicine (D.M.Y.), University of Pittsburgh School of Medicine, Pittsburgh; the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Interdepartmental Division of Critical Care Medicine, Department of Medicine, University Health Network and Sinai Health System, University of Toronto, Toronto (N.D.F.); the Department of Medicine, Montefiore Hospital, New York (M.N.G.); the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (S.G., C.L.H.); the Biostatistics Center (D.H.), the Department of Medicine (B.T.T.), and the PETAL Network Clinical Coordinating Center (C.A.U.), Massachusetts General Hospital, the Department of Emergency Medicine, Division of Emergency Critical Care Medicine, Brigham and Women's Hospital (P.C.H.), and the Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center (D.T.) - all in Boston; the Department of Critical Care, Respiratory Institute, Cleveland Clinic, Cleveland (R.D.H.); the Department of Medicine, University of Michigan and Veterans Affairs Center for Clinical Research, Ann Arbor (T.J.I.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); and the Departments of Medicine and Anesthesia, University of California, San Francisco, San Francisco (K.D.L.).""}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Hayden', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Departments of Medicine (M.M.) and Emergency Medicine (A.A.G.), University of Colorado School of Medicine, Aurora; the Departments of Critical Care Medicine (D.T.H., D.C.A.) and Emergency Medicine (D.M.Y.), University of Pittsburgh School of Medicine, Pittsburgh; the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Interdepartmental Division of Critical Care Medicine, Department of Medicine, University Health Network and Sinai Health System, University of Toronto, Toronto (N.D.F.); the Department of Medicine, Montefiore Hospital, New York (M.N.G.); the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (S.G., C.L.H.); the Biostatistics Center (D.H.), the Department of Medicine (B.T.T.), and the PETAL Network Clinical Coordinating Center (C.A.U.), Massachusetts General Hospital, the Department of Emergency Medicine, Division of Emergency Critical Care Medicine, Brigham and Women's Hospital (P.C.H.), and the Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center (D.T.) - all in Boston; the Department of Critical Care, Respiratory Institute, Cleveland Clinic, Cleveland (R.D.H.); the Department of Medicine, University of Michigan and Veterans Affairs Center for Clinical Research, Ann Arbor (T.J.I.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); and the Departments of Medicine and Anesthesia, University of California, San Francisco, San Francisco (K.D.L.).""}, {'ForeName': 'R Duncan', 'Initials': 'RD', 'LastName': 'Hite', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Departments of Medicine (M.M.) and Emergency Medicine (A.A.G.), University of Colorado School of Medicine, Aurora; the Departments of Critical Care Medicine (D.T.H., D.C.A.) and Emergency Medicine (D.M.Y.), University of Pittsburgh School of Medicine, Pittsburgh; the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Interdepartmental Division of Critical Care Medicine, Department of Medicine, University Health Network and Sinai Health System, University of Toronto, Toronto (N.D.F.); the Department of Medicine, Montefiore Hospital, New York (M.N.G.); the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (S.G., C.L.H.); the Biostatistics Center (D.H.), the Department of Medicine (B.T.T.), and the PETAL Network Clinical Coordinating Center (C.A.U.), Massachusetts General Hospital, the Department of Emergency Medicine, Division of Emergency Critical Care Medicine, Brigham and Women's Hospital (P.C.H.), and the Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center (D.T.) - all in Boston; the Department of Critical Care, Respiratory Institute, Cleveland Clinic, Cleveland (R.D.H.); the Department of Medicine, University of Michigan and Veterans Affairs Center for Clinical Research, Ann Arbor (T.J.I.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); and the Departments of Medicine and Anesthesia, University of California, San Francisco, San Francisco (K.D.L.).""}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Hou', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Departments of Medicine (M.M.) and Emergency Medicine (A.A.G.), University of Colorado School of Medicine, Aurora; the Departments of Critical Care Medicine (D.T.H., D.C.A.) and Emergency Medicine (D.M.Y.), University of Pittsburgh School of Medicine, Pittsburgh; the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Interdepartmental Division of Critical Care Medicine, Department of Medicine, University Health Network and Sinai Health System, University of Toronto, Toronto (N.D.F.); the Department of Medicine, Montefiore Hospital, New York (M.N.G.); the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (S.G., C.L.H.); the Biostatistics Center (D.H.), the Department of Medicine (B.T.T.), and the PETAL Network Clinical Coordinating Center (C.A.U.), Massachusetts General Hospital, the Department of Emergency Medicine, Division of Emergency Critical Care Medicine, Brigham and Women's Hospital (P.C.H.), and the Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center (D.T.) - all in Boston; the Department of Critical Care, Respiratory Institute, Cleveland Clinic, Cleveland (R.D.H.); the Department of Medicine, University of Michigan and Veterans Affairs Center for Clinical Research, Ann Arbor (T.J.I.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); and the Departments of Medicine and Anesthesia, University of California, San Francisco, San Francisco (K.D.L.).""}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Hough', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Departments of Medicine (M.M.) and Emergency Medicine (A.A.G.), University of Colorado School of Medicine, Aurora; the Departments of Critical Care Medicine (D.T.H., D.C.A.) and Emergency Medicine (D.M.Y.), University of Pittsburgh School of Medicine, Pittsburgh; the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Interdepartmental Division of Critical Care Medicine, Department of Medicine, University Health Network and Sinai Health System, University of Toronto, Toronto (N.D.F.); the Department of Medicine, Montefiore Hospital, New York (M.N.G.); the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (S.G., C.L.H.); the Biostatistics Center (D.H.), the Department of Medicine (B.T.T.), and the PETAL Network Clinical Coordinating Center (C.A.U.), Massachusetts General Hospital, the Department of Emergency Medicine, Division of Emergency Critical Care Medicine, Brigham and Women's Hospital (P.C.H.), and the Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center (D.T.) - all in Boston; the Department of Critical Care, Respiratory Institute, Cleveland Clinic, Cleveland (R.D.H.); the Department of Medicine, University of Michigan and Veterans Affairs Center for Clinical Research, Ann Arbor (T.J.I.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); and the Departments of Medicine and Anesthesia, University of California, San Francisco, San Francisco (K.D.L.).""}, {'ForeName': 'Theodore J', 'Initials': 'TJ', 'LastName': 'Iwashyna', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Departments of Medicine (M.M.) and Emergency Medicine (A.A.G.), University of Colorado School of Medicine, Aurora; the Departments of Critical Care Medicine (D.T.H., D.C.A.) and Emergency Medicine (D.M.Y.), University of Pittsburgh School of Medicine, Pittsburgh; the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Interdepartmental Division of Critical Care Medicine, Department of Medicine, University Health Network and Sinai Health System, University of Toronto, Toronto (N.D.F.); the Department of Medicine, Montefiore Hospital, New York (M.N.G.); the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (S.G., C.L.H.); the Biostatistics Center (D.H.), the Department of Medicine (B.T.T.), and the PETAL Network Clinical Coordinating Center (C.A.U.), Massachusetts General Hospital, the Department of Emergency Medicine, Division of Emergency Critical Care Medicine, Brigham and Women's Hospital (P.C.H.), and the Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center (D.T.) - all in Boston; the Department of Critical Care, Respiratory Institute, Cleveland Clinic, Cleveland (R.D.H.); the Department of Medicine, University of Michigan and Veterans Affairs Center for Clinical Research, Ann Arbor (T.J.I.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); and the Departments of Medicine and Anesthesia, University of California, San Francisco, San Francisco (K.D.L.).""}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Departments of Medicine (M.M.) and Emergency Medicine (A.A.G.), University of Colorado School of Medicine, Aurora; the Departments of Critical Care Medicine (D.T.H., D.C.A.) and Emergency Medicine (D.M.Y.), University of Pittsburgh School of Medicine, Pittsburgh; the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Interdepartmental Division of Critical Care Medicine, Department of Medicine, University Health Network and Sinai Health System, University of Toronto, Toronto (N.D.F.); the Department of Medicine, Montefiore Hospital, New York (M.N.G.); the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (S.G., C.L.H.); the Biostatistics Center (D.H.), the Department of Medicine (B.T.T.), and the PETAL Network Clinical Coordinating Center (C.A.U.), Massachusetts General Hospital, the Department of Emergency Medicine, Division of Emergency Critical Care Medicine, Brigham and Women's Hospital (P.C.H.), and the Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center (D.T.) - all in Boston; the Department of Critical Care, Respiratory Institute, Cleveland Clinic, Cleveland (R.D.H.); the Department of Medicine, University of Michigan and Veterans Affairs Center for Clinical Research, Ann Arbor (T.J.I.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); and the Departments of Medicine and Anesthesia, University of California, San Francisco, San Francisco (K.D.L.).""}, {'ForeName': 'Kathleen D', 'Initials': 'KD', 'LastName': 'Liu', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Departments of Medicine (M.M.) and Emergency Medicine (A.A.G.), University of Colorado School of Medicine, Aurora; the Departments of Critical Care Medicine (D.T.H., D.C.A.) and Emergency Medicine (D.M.Y.), University of Pittsburgh School of Medicine, Pittsburgh; the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Interdepartmental Division of Critical Care Medicine, Department of Medicine, University Health Network and Sinai Health System, University of Toronto, Toronto (N.D.F.); the Department of Medicine, Montefiore Hospital, New York (M.N.G.); the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (S.G., C.L.H.); the Biostatistics Center (D.H.), the Department of Medicine (B.T.T.), and the PETAL Network Clinical Coordinating Center (C.A.U.), Massachusetts General Hospital, the Department of Emergency Medicine, Division of Emergency Critical Care Medicine, Brigham and Women's Hospital (P.C.H.), and the Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center (D.T.) - all in Boston; the Department of Critical Care, Respiratory Institute, Cleveland Clinic, Cleveland (R.D.H.); the Department of Medicine, University of Michigan and Veterans Affairs Center for Clinical Research, Ann Arbor (T.J.I.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); and the Departments of Medicine and Anesthesia, University of California, San Francisco, San Francisco (K.D.L.).""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Talmor', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Departments of Medicine (M.M.) and Emergency Medicine (A.A.G.), University of Colorado School of Medicine, Aurora; the Departments of Critical Care Medicine (D.T.H., D.C.A.) and Emergency Medicine (D.M.Y.), University of Pittsburgh School of Medicine, Pittsburgh; the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Interdepartmental Division of Critical Care Medicine, Department of Medicine, University Health Network and Sinai Health System, University of Toronto, Toronto (N.D.F.); the Department of Medicine, Montefiore Hospital, New York (M.N.G.); the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (S.G., C.L.H.); the Biostatistics Center (D.H.), the Department of Medicine (B.T.T.), and the PETAL Network Clinical Coordinating Center (C.A.U.), Massachusetts General Hospital, the Department of Emergency Medicine, Division of Emergency Critical Care Medicine, Brigham and Women's Hospital (P.C.H.), and the Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center (D.T.) - all in Boston; the Department of Critical Care, Respiratory Institute, Cleveland Clinic, Cleveland (R.D.H.); the Department of Medicine, University of Michigan and Veterans Affairs Center for Clinical Research, Ann Arbor (T.J.I.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); and the Departments of Medicine and Anesthesia, University of California, San Francisco, San Francisco (K.D.L.).""}, {'ForeName': 'B Taylor', 'Initials': 'BT', 'LastName': 'Thompson', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Departments of Medicine (M.M.) and Emergency Medicine (A.A.G.), University of Colorado School of Medicine, Aurora; the Departments of Critical Care Medicine (D.T.H., D.C.A.) and Emergency Medicine (D.M.Y.), University of Pittsburgh School of Medicine, Pittsburgh; the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Interdepartmental Division of Critical Care Medicine, Department of Medicine, University Health Network and Sinai Health System, University of Toronto, Toronto (N.D.F.); the Department of Medicine, Montefiore Hospital, New York (M.N.G.); the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (S.G., C.L.H.); the Biostatistics Center (D.H.), the Department of Medicine (B.T.T.), and the PETAL Network Clinical Coordinating Center (C.A.U.), Massachusetts General Hospital, the Department of Emergency Medicine, Division of Emergency Critical Care Medicine, Brigham and Women's Hospital (P.C.H.), and the Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center (D.T.) - all in Boston; the Department of Critical Care, Respiratory Institute, Cleveland Clinic, Cleveland (R.D.H.); the Department of Medicine, University of Michigan and Veterans Affairs Center for Clinical Research, Ann Arbor (T.J.I.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); and the Departments of Medicine and Anesthesia, University of California, San Francisco, San Francisco (K.D.L.).""}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Ulysse', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Departments of Medicine (M.M.) and Emergency Medicine (A.A.G.), University of Colorado School of Medicine, Aurora; the Departments of Critical Care Medicine (D.T.H., D.C.A.) and Emergency Medicine (D.M.Y.), University of Pittsburgh School of Medicine, Pittsburgh; the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Interdepartmental Division of Critical Care Medicine, Department of Medicine, University Health Network and Sinai Health System, University of Toronto, Toronto (N.D.F.); the Department of Medicine, Montefiore Hospital, New York (M.N.G.); the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (S.G., C.L.H.); the Biostatistics Center (D.H.), the Department of Medicine (B.T.T.), and the PETAL Network Clinical Coordinating Center (C.A.U.), Massachusetts General Hospital, the Department of Emergency Medicine, Division of Emergency Critical Care Medicine, Brigham and Women's Hospital (P.C.H.), and the Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center (D.T.) - all in Boston; the Department of Critical Care, Respiratory Institute, Cleveland Clinic, Cleveland (R.D.H.); the Department of Medicine, University of Michigan and Veterans Affairs Center for Clinical Research, Ann Arbor (T.J.I.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); and the Departments of Medicine and Anesthesia, University of California, San Francisco, San Francisco (K.D.L.).""}, {'ForeName': 'Donald M', 'Initials': 'DM', 'LastName': 'Yealy', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Departments of Medicine (M.M.) and Emergency Medicine (A.A.G.), University of Colorado School of Medicine, Aurora; the Departments of Critical Care Medicine (D.T.H., D.C.A.) and Emergency Medicine (D.M.Y.), University of Pittsburgh School of Medicine, Pittsburgh; the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Interdepartmental Division of Critical Care Medicine, Department of Medicine, University Health Network and Sinai Health System, University of Toronto, Toronto (N.D.F.); the Department of Medicine, Montefiore Hospital, New York (M.N.G.); the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (S.G., C.L.H.); the Biostatistics Center (D.H.), the Department of Medicine (B.T.T.), and the PETAL Network Clinical Coordinating Center (C.A.U.), Massachusetts General Hospital, the Department of Emergency Medicine, Division of Emergency Critical Care Medicine, Brigham and Women's Hospital (P.C.H.), and the Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center (D.T.) - all in Boston; the Department of Critical Care, Respiratory Institute, Cleveland Clinic, Cleveland (R.D.H.); the Department of Medicine, University of Michigan and Veterans Affairs Center for Clinical Research, Ann Arbor (T.J.I.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); and the Departments of Medicine and Anesthesia, University of California, San Francisco, San Francisco (K.D.L.).""}, {'ForeName': 'Derek C', 'Initials': 'DC', 'LastName': 'Angus', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Departments of Medicine (M.M.) and Emergency Medicine (A.A.G.), University of Colorado School of Medicine, Aurora; the Departments of Critical Care Medicine (D.T.H., D.C.A.) and Emergency Medicine (D.M.Y.), University of Pittsburgh School of Medicine, Pittsburgh; the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Interdepartmental Division of Critical Care Medicine, Department of Medicine, University Health Network and Sinai Health System, University of Toronto, Toronto (N.D.F.); the Department of Medicine, Montefiore Hospital, New York (M.N.G.); the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (S.G., C.L.H.); the Biostatistics Center (D.H.), the Department of Medicine (B.T.T.), and the PETAL Network Clinical Coordinating Center (C.A.U.), Massachusetts General Hospital, the Department of Emergency Medicine, Division of Emergency Critical Care Medicine, Brigham and Women's Hospital (P.C.H.), and the Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center (D.T.) - all in Boston; the Department of Critical Care, Respiratory Institute, Cleveland Clinic, Cleveland (R.D.H.); the Department of Medicine, University of Michigan and Veterans Affairs Center for Clinical Research, Ann Arbor (T.J.I.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); and the Departments of Medicine and Anesthesia, University of California, San Francisco, San Francisco (K.D.L.).""}]",The New England journal of medicine,['10.1056/NEJMoa1901686']
3561,31654697,Brain functional connectivity after cognitive-bias modification and behavioral changes in abstinent alcohol-use disorder patients.,"The use of the cognitive-bias modification (CBM) method has emerged as a therapeutic complement in the treatment of alcoholism, producing changes at behavioral and brain level. Nevertheless, the impact of the CBM procedure could be improved by the memory retrieval-extinction process (REP). Different studies have demonstrated that the retrieval of drug memories before extinction training later reduced the reinstatement of drug-seeking behavior. The main aim of this work was to study the effect of the CBM procedure itself, as well as in combination with the activation of alcohol-related memories, on the brain oscillatory activity of abstinent patients with alcohol-use disorder. The study sample comprised 33 patients divided into three groups: A-CBM (alcohol-related memory activation + CBM), N-CBM (neutral memory activation + CBM) and N-INT (no-intervention) groups. A resting-state EEG was obtained before and after each protocol, along with the assessment of the automatic action tendencies. A-CBM group showed a general alpha synchronization increase after the protocol, while the other groups did not show any significant change. Besides, A-CBM group showed significant intra and inter-group differences in the automatic action tendencies after the protocol, reflected in higher avoidance bias toward appetitive, aversive and without context alcohol-related stimuli. The alpha phase synchronization increase could be the neural manifestation of the conditioning produced between the alcohol-related stimuli and the automatic avoidance response. Moreover, the activation of the alcohol-related memories favors this conditioning with those alcohol-related stimuli associated with the activated memories, because it increases their threat level for the abstinence maintenance.",2020,"Besides, A-CBM group showed significant intra and inter-group differences in the automatic action tendencies after the protocol, reflected in higher avoidance bias toward appetitive, aversive and without context alcohol-related stimuli.","['abstinent alcohol-use disorder patients', '33 patients divided into three groups: A', 'abstinent patients with alcohol-use disorder']","['CBM (alcohol-related memory activation\u202f+\u202fCBM), N-CBM (neutral memory activation\u202f+\u202fCBM) and N-INT (no-intervention', 'cognitive-bias modification (CBM']","['general alpha synchronization increase', 'higher avoidance bias toward appetitive, aversive and without context alcohol-related stimuli', 'automatic action tendencies']","[{'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0005346', 'cui_str': 'Bias'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0449255', 'cui_str': 'Context (attribute)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}]",,0.0159507,"Besides, A-CBM group showed significant intra and inter-group differences in the automatic action tendencies after the protocol, reflected in higher avoidance bias toward appetitive, aversive and without context alcohol-related stimuli.","[{'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Martínez-Maldonado', 'Affiliation': 'Biomedical Research Institute Hospital 12 de Octubre, Cordoba Ave., s/n, 28041 Madrid, Spain; Psychology Department, Education and Health Science Faculty, Camilo José Cela University, Villafranca del Castillo Urb., Castillo de Alarcón St., 49, 28692 Villanueva de la Cañada, Madrid, Spain. Electronic address: andresmartinezmaldonado.imas12@h12o.es.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Jurado-Barba', 'Affiliation': 'Biomedical Research Institute Hospital 12 de Octubre, Cordoba Ave., s/n, 28041 Madrid, Spain; Psychology Department, Education and Health Science Faculty, Camilo José Cela University, Villafranca del Castillo Urb., Castillo de Alarcón St., 49, 28692 Villanueva de la Cañada, Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Sion', 'Affiliation': 'Biomedical Research Institute Hospital 12 de Octubre, Cordoba Ave., s/n, 28041 Madrid, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Domínguez-Centeno', 'Affiliation': 'Biomedical Research Institute Hospital 12 de Octubre, Cordoba Ave., s/n, 28041 Madrid, Spain; Psychology Department, Education and Health Science Faculty, Camilo José Cela University, Villafranca del Castillo Urb., Castillo de Alarcón St., 49, 28692 Villanueva de la Cañada, Madrid, Spain.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Castillo-Parra', 'Affiliation': 'Psychology Department, Education and Health Science Faculty, Camilo José Cela University, Villafranca del Castillo Urb., Castillo de Alarcón St., 49, 28692 Villanueva de la Cañada, Madrid, Spain.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Prieto-Montalvo', 'Affiliation': 'Department of Clinical Neurophysiology, Hospital Gregorio Marañon, Dr Esquerdo St., 46, 28007 Madrid, Spain.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Rubio', 'Affiliation': 'Biomedical Research Institute Hospital 12 de Octubre, Cordoba Ave., s/n, 28041 Madrid, Spain; Medicine Faculty, Complutense de Madrid University, Ramón y Cajal Sq., s/n, 28040 Madrid, Spain; Addictive Disorders Network, Carlos III Institute, Sinesio Delgado St., 4, 28029 Madrid, Spain.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2019.10.004']
3562,31698290,Effects of pressure ulcer prevention training among nurses in long-term care hospitals.,"BACKGROUND


Nurses caring for elderly patients with a high risk of pressure ulcer at long-term care hospitals require the necessary knowledge, behaviors, and attitudes regarding preventing pressure ulcers.
OBJECTIVES


To identify the effects of pressure ulcer prevention training on nurses' knowledge, behaviors, and attitudes regarding pressure ulcer prevention.
DESIGN


A comparison group pretest-posttest design.
SETTINGS


Long-term care hospitals in a metropolitan area of the Republic of Korea.
PARTICIPANTS


Participants were conveniently assigned to team-based learning (n = 30) or lecture-based learning (n = 30) groups.
METHODS


We examined pre-post differences in the scores for pressure ulcer prevention knowledge, behaviors, and attitudes in each group using the paired t-test. Additionally, pre-post difference scores were compared between the two groups using the independent samples t-test.
RESULTS


Both groups exhibited significant increases in scores for pressure ulcer prevention knowledge, behaviors, and attitudes after the intervention as compared before it. However, we found no significant differences in the pre-post difference scores for any of the variables between the two groups.
CONCLUSIONS


Pressure ulcer prevention training, regardless of whether it utilizes team-based or lecture-based learning, is useful for enhancing nurses' pressure ulcer prevention knowledge, behaviors, and attitudes. Further study is needed to verify the longitudinal effects of pressure ulcer prevention training on nurses' actual performance and the incidence of pressure ulcers among patients.",2020,"Both groups exhibited significant increases in scores for pressure ulcer prevention knowledge, behaviors, and attitudes after the intervention as compared before it.","['elderly patients with a high risk of pressure ulcer at long-term care hospitals', 'patients', 'nurses in long-term care hospitals', 'Long-term care hospitals in a metropolitan area of the Republic of Korea', 'Participants were conveniently assigned to']","['pressure ulcer prevention training', 'team-based learning (n\u202f=\u202f30) or lecture-based learning']","['scores for pressure ulcer prevention knowledge, behaviors, and attitudes', 'pressure ulcer prevention knowledge, behaviors, and attitudes']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0011127', 'cui_str': 'Pressure Ulcer'}, {'cui': 'C0557850', 'cui_str': 'Long term care hospital (environment)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0150315', 'cui_str': 'Pressure sore protection'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0150315', 'cui_str': 'Pressure sore protection'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.0140272,"Both groups exhibited significant increases in scores for pressure ulcer prevention knowledge, behaviors, and attitudes after the intervention as compared before it.","[{'ForeName': 'Yukyeong', 'Initials': 'Y', 'LastName': 'Seo', 'Affiliation': 'Graduate School of Nursing and Health Professions, Chung-Ang University, Seoul, Republic of Korea.'}, {'ForeName': 'Young Sook', 'Initials': 'YS', 'LastName': 'Roh', 'Affiliation': 'Red Cross College of Nursing, Chung-Ang University, 84 Heukseok-ro Dongjak-gu, Seoul 06974, Republic of Korea. Electronic address: aqua@cau.ac.kr.'}]",Nurse education today,['10.1016/j.nedt.2019.104225']
3563,31630538,Cryoballoon or Radiofrequency Ablation for Atrial Fibrillation Assessed by Continuous Monitoring: A Randomized Clinical Trial.,"BACKGROUND


Advanced generation ablation technologies have been developed to achieve more effective pulmonary vein isolation (PVI) and minimize arrhythmia recurrence after atrial fibrillation (AF) ablation.
METHODS


We randomly assigned 346 patients with drug-refractory paroxysmal AF to contact force-guided radiofrequency ablation (CF-RF; n=115), 4-minute cryoballoon ablation (Cryo-4; n=115), or 2-minute cryoballoon ablation (Cryo-2; n=116). Follow-up was 12 months. The primary outcome was time to first documented recurrence of symptomatic or asymptomatic atrial tachyarrhythmia (AF, atrial flutter, or atrial tachycardia) between days 91 and 365 after ablation or a repeat ablation procedure at any time. Secondary end points included freedom from symptomatic arrhythmia and AF burden. All patients received an implantable loop recorder.
RESULTS


One-year freedom from atrial tachyarrhythmia defined by continuous rhythm monitoring was 53.9%, 52.2%, and 51.7% with CF-RF, Cryo-4, and Cryo-2, respectively ( P =0.87). One-year freedom from symptomatic atrial tachyarrhythmia defined by continuous rhythm monitoring was 79.1%, 78.2%, and 73.3% with CF-RF, Cryo-4, and Cryo-2, respectively ( P =0.26). Compared with the monitoring period before ablation, AF burden was reduced by a median of 99.3% (interquartile range, 67.8%-100.0%) with CF-RF, 99.9% (interquartile range, 65.3%-100.0%) with Cryo-4, and 98.4% (interquartile range, 56.2%-100.0%) with Cryo-2 ( P =0.36). Serious adverse events occurred in 3 patients (2.6%) in the CF-RF group, 6 patients (5.3%) in the Cryo-4 group, and 7 patients (6.0%) in the Cryo-2 group, with no significant difference between groups ( P =0.24). The CF-RF group had a significantly longer procedure duration but significantly shorter fluoroscopy exposure ( P <0.001 vs cryoballoon groups).
CONCLUSIONS


In this multicenter, randomized, single-blinded trial, CF-RF and 2 different regimens of cryoballoon ablation resulted in no difference in 1-year efficacy, which was 53% by time to first recurrence but >98% burden reduction as assessed by continuous cardiac rhythm monitoring.
CLINICAL TRIAL REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT01913522.",2019,The CF-RF group had a significantly longer procedure duration but significantly shorter fluoroscopy exposure (P<0.001 vs. cryoballoon groups).  ,['346 patients with drug-refractory paroxysmal AF to'],"['Cryoballoon or Radiofrequency Ablation', 'cryoballoon ablation', 'contact-force RF ablation', 'implantable loop recorder', 'contactforce guided RF ablation (CF-RF ablation, 115), 4-minute cryoballoon ablation (CRYO-4, 115), or 2-minute cryoballoon ablation']","['freedom from symptomatic arrhythmia, and AF burden', 'AF burden', 'time to first documented recurrence of symptomatic or asymptomatic atrial tachyarrhythmia (AF, atrial flutter, or atrial tachycardia', 'repeat ablation procedure at any time', 'atrial tachyarrhythmia defined by continuous rhythm monitoring', 'procedure duration', 'Serious adverse events', 'symptomatic atrial tachyarrhythmia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0205311', 'cui_str': 'Paroxysmal (qualifier value)'}]","[{'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C4552498', 'cui_str': 'Implantable loop recorder'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]","[{'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0003811', 'cui_str': 'Arrhythmia'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0080203', 'cui_str': 'Tachyarrhythmia'}, {'cui': 'C0004239', 'cui_str': 'Auricular Flutter'}, {'cui': 'C0546959', 'cui_str': 'Atrial tachycardia (disorder)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",346.0,0.267623,The CF-RF group had a significantly longer procedure duration but significantly shorter fluoroscopy exposure (P<0.001 vs. cryoballoon groups).  ,"[{'ForeName': 'Jason G', 'Initials': 'JG', 'LastName': 'Andrade', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Montreal, Canada (J.G.A., M.D., L.M., P.K.).'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Champagne', 'Affiliation': 'Université Laval, Quebec City, Canada (J.C., C.S.).'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Dubuc', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Montreal, Canada (J.G.A., M.D., L.M., P.K.).'}, {'ForeName': 'Marc W', 'Initials': 'MW', 'LastName': 'Deyell', 'Affiliation': 'Heart Rhythm Services, Department of Medicine, University of British Columbia, Vancouver, Canada (J.G.A., M.W.D., M.T.B.).'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Verma', 'Affiliation': 'Southlake Regional Health Center, Newmarket, Canada (A.V.).'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Macle', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Montreal, Canada (J.G.A., M.D., L.M., P.K.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Leong-Sit', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Canada (P.L.-S., A.S.L.T.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Novak', 'Affiliation': 'Royal Jubilee Hospital, Victoria, Canada (P.N.).'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Badra-Verdu', 'Affiliation': 'Centre Hospitalier Universitaire de Sherbrooke, Canada (M.B.-V.).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sapp', 'Affiliation': 'Queen Elizabeth II Health Sciences Centre and Dalhousie University, Halifax, Canada (J.S.).'}, {'ForeName': 'Iqwal', 'Initials': 'I', 'LastName': 'Mangat', 'Affiliation': ""Department of Medicine, St Michael's Hospital, Toronto, Canada (I.M.).""}, {'ForeName': 'Clarence', 'Initials': 'C', 'LastName': 'Khoo', 'Affiliation': 'University of Winnipeg, Canada (C.K.).'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Steinberg', 'Affiliation': 'Université Laval, Quebec City, Canada (J.C., C.S.).'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Bennett', 'Affiliation': 'Heart Rhythm Services, Department of Medicine, University of British Columbia, Vancouver, Canada (J.G.A., M.W.D., M.T.B.).'}, {'ForeName': 'Anthony S L', 'Initials': 'ASL', 'LastName': 'Tang', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Canada (P.L.-S., A.S.L.T.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Khairy', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Montreal, Canada (J.G.A., M.D., L.M., P.K.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.119.042622']
3564,31752977,"Tamoxifen in Duchenne muscular dystrophy (TAMDMD): study protocol for a multicenter, randomized, placebo-controlled, double-blind phase 3 trial.","BACKGROUND


Duchenne muscular dystrophy (DMD) is an inherited neuromuscular disorder of childhood with a devastating disease course. Several targeted gene therapies and molecular approaches have been or are currently being tested in clinical trials; however, a causative therapy is still not available and best supportive care is limited to oral glucocorticoids with numerous long-term side effects. Tamoxifen is a selective estrogen receptor regulator, and shows antioxidant actions and regulatory roles in the calcium homeostasis besides its antitumor activity. In a mouse model of DMD, oral tamoxifen significantly improved muscle strength and reduced muscle fatigue. This multicenter, randomized, double-blind, placebo-controlled phase III trial aims to demonstrate safety and efficacy of tamoxifen over placebo in pediatric patients with DMD. After completion of the double-blind phase, an open-label extension of the study will be offered to all participants.
METHODS/DESIGN


At least 71 ambulant and up to 20 nonambulant patients with DMD are planned to be enrolled at multiple European sites. Patients will be randomly assigned to receive either tamoxifen 20 mg or placebo daily over 48 weeks. In the open-label extension phase, all patients will be offered tamoxifen for a further 48 weeks. The primary endpoint of the double-blind phase is defined as the change of the D1 domain of the motor function measure in ambulant patients or a change of the D2 domain in nonambulant patients under tamoxifen compared to placebo. Secondary outcome measures include change in timed function tests, quantitative muscle testing, and quantitative magnetic resonance imaging of thigh muscles. Laboratory analyses including biomarkers of tamoxifen metabolism and muscle dystrophy will also be assessed.
DISCUSSION


The aim of the study is to investigate whether tamoxifen can reduce disease progression in ambulant and nonambulant patients with DMD over 48 weeks. Motor function measures comprise the primary endpoint, whereas further clinical and radiological assessments and laboratory biomarkers are performed to provide more data on safety and efficacy. An adjacent open-label extension phase is planned to test if earlier initiation of the treatment with tamoxifen (verum arm of double-blind phase) compared to a delayed start can reduce disease progression more efficiently.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03354039. Registered on 27 November 2017.",2019,"In a mouse model of DMD, oral tamoxifen significantly improved muscle strength and reduced muscle fatigue.","['ambulant and nonambulant patients with DMD over 48\u2009weeks', '20 nonambulant patients with DMD are planned to be enrolled at multiple European sites', 'pediatric patients with DMD']","['placebo', 'Tamoxifen', 'Duchenne muscular dystrophy (DMD', 'tamoxifen', 'tamoxifen 20\u2009mg or placebo']","['muscle strength and reduced muscle fatigue', 'disease progression', 'change in timed function tests, quantitative muscle testing, and quantitative magnetic resonance imaging of thigh muscles', 'change of the D1 domain of the motor function measure', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0013264', 'cui_str': 'Cardiomyopathy, Dilated, X-Linked'}, {'cui': 'C1126289', 'cui_str': 'Tamoxifen 20 MG'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0242979', 'cui_str': 'Muscular Fatigue'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0412713', 'cui_str': 'Magnetic resonance imaging of thigh'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.722199,"In a mouse model of DMD, oral tamoxifen significantly improved muscle strength and reduced muscle fatigue.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Nagy', 'Affiliation': ""Division of Developmental- and Neuropaediatrics, University Children's Hospital Basel (UKBB), University of Basel, Spitalstrasse 33, Postfach, 4031, Basel, Switzerland. sara.nagy@ukbb.ch.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Hafner', 'Affiliation': ""Division of Developmental- and Neuropaediatrics, University Children's Hospital Basel (UKBB), University of Basel, Spitalstrasse 33, Postfach, 4031, Basel, Switzerland.""}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': ""Division of Developmental- and Neuropaediatrics, University Children's Hospital Basel (UKBB), University of Basel, Spitalstrasse 33, Postfach, 4031, Basel, Switzerland.""}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Rubino-Nacht', 'Affiliation': ""Division of Developmental- and Neuropaediatrics, University Children's Hospital Basel (UKBB), University of Basel, Spitalstrasse 33, Postfach, 4031, Basel, Switzerland.""}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schädelin', 'Affiliation': 'Clinical Trial Unit, University of Basel, Schanzenstrasse 55, 4056, Basel, Switzerland.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Bieri', 'Affiliation': 'Department of Radiology, Division of Radiological Physics, University Hospital Basel, University of Basel, Petersgraben 4, 4031, Basel, Switzerland.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Fischer', 'Affiliation': ""Division of Developmental- and Neuropaediatrics, University Children's Hospital Basel (UKBB), University of Basel, Spitalstrasse 33, Postfach, 4031, Basel, Switzerland.""}]",Trials,['10.1186/s13063-019-3740-6']
3565,31707069,Multisymptom Profile Predicts Increased Risk of Poor Outcomes After Initial Placement of Implantable Cardioverter Defibrillator.,"CONTEXT


Patients with implantable cardioverter defibrillators (ICDs) are at risk for multiple physical and psychological symptoms. Identification of specific symptom profiles associated with poor outcomes may elucidate novel strategies to enhance symptom management.
OBJECTIVES


The objectives were to determine common symptoms after initial ICD implantation, identify classes of individuals with similar symptom profiles, describe patient characteristics associated with different symptom profiles, and determine if symptom profiles at hospital discharge predicted outcomes three and 12 months after implantation.
METHODS


This was a secondary data analysis of a randomized controlled trial that compared patient + partner versus patient-only interventions designed to help patients manage symptoms, prepare for ICD shocks, and resume daily activities. Symptoms were measured with the Patient Concerns Assessment. Latent class regression analysis was used to identify symptom classes at baseline, three-month, and 12-month follow-up. Associations between patient characteristics, class membership, and outcomes were examined using chi-square, analysis of variance, and Poisson regression.
RESULTS


The study included 301 patients (74% male, mean age 64 ± 11.9 years). Three classes were identified: Multi-Symptom (N = 119, 40%), Tired-Rundown (N = 130, 43%), and Mostly Asymptomatic (N = 52, 17%). Patients in the Multi-Symptom class were younger (59.9 years, P < 0.001) and reported more anxiety (P < 0.001) and depression (P < 0.01) than the other classes. Membership in the Multi-Symptom class predicted lower quality of life and resulted in nearly double the rate of hospitalizations after 12 months (P = 0.02, IRR 1.9).
CONCLUSION


Evaluation of symptom profiles after ICD implantation offers a promising strategy for identifying patients at risk for poor health outcomes.",2020,"Membership in the Multi-Symptom class predicted lower quality of life and nearly double the rate of hospitalizations after 12 months (p = 0.02, IRR 1.9).
","['301 patients (74% male, mean age 64±11.9 years']","['Patient+Partner', 'implantable cardioverter defibrillators (ICD', 'Implantable Cardioverter Defibrillator', 'ICD implantation']","['rate of hospitalizations', 'anxiety', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0162589', 'cui_str': 'Implantable Cardioverter-Defibrillators'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0034380'}]",301.0,0.0785381,"Membership in the Multi-Symptom class predicted lower quality of life and nearly double the rate of hospitalizations after 12 months (p = 0.02, IRR 1.9).
","[{'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Streur', 'Affiliation': 'Biobehavioral Nursing and Health Informatics, School of Nursing, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Elaine A', 'Initials': 'EA', 'LastName': 'Thompson', 'Affiliation': 'Biobehavioral Nursing and Health Informatics, School of Nursing, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Dougherty', 'Affiliation': 'Biobehavioral Nursing and Health Informatics, School of Nursing, University of Washington, Seattle, Washington, USA. Electronic address: cindyd@uw.edu.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2019.10.024']
3566,32091953,The Effects of Deep Brain Stimulation on Speech Intelligibility in Persons With Essential Tremor.,"Purpose The aim of this study was to investigate how deep brain stimulation (DBS) of the caudal zona incerta (cZi) affects speech intelligibility in persons with essential tremor. Method Thirty-five participants were evaluated: off stimulation, on chronic stimulation optimized to alleviate tremor, and during unilateral stimulation at increasing amplitude levels. At each stimulation condition, the participants read 10 unique nonsense sentences from the Swedish Test of Intelligibility. Two listeners, blinded to stimulation condition, transcribed all recorded sentences orthographically in a randomized procedure. A mean speech intelligibility score for each patient and stimulation condition was computed, and comparisons were made between scores off and on stimulation. Results Chronic cZi-DBS had no significant effect on speech intelligibility, and there was no difference in outcome between bilateral and unilateral treatments. During unilateral stimulation at increasing amplitudes, nine participants demonstrated deteriorating speech intelligibility. These nine participants were on average older and had more superior contacts activated during the evaluation compared with the participants without deterioration. Conclusions Chronic cZi-DBS, optimized for tremor suppression, does not generally affect speech intelligibility in persons with essential tremor. Furthermore, speech intelligibility may be preserved in many individuals, even when stimulated at high amplitudes. Adverse effects of high-amplitude unilateral stimulation observed in this study were associated with stimulation originating from a more superior location, as well as with the participants' age. These results, highlighting age and stimulation location as contributing to speech intelligibility outcomes, were, however, based on a limited number of individuals experiencing adverse effects with high-amplitude stimulation and should, therefore, be interpreted with caution.",2020,"Results Chronic cZi-DBS had no significant effect on speech intelligibility, and there was no difference in outcome between bilateral and unilateral treatments.","['persons with essential tremor', 'Persons With Essential Tremor']","['Deep Brain Stimulation', 'deep brain stimulation (DBS) of the caudal zona incerta (cZi']","['mean speech intelligibility score', 'deteriorating speech intelligibility', 'Speech Intelligibility', 'speech intelligibility']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0270736', 'cui_str': 'Benign Essential Tremor'}]","[{'cui': 'C0394162', 'cui_str': 'Deep Brain Stimulation'}, {'cui': 'C3852973', 'cui_str': 'Caudal Zona Incerta'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",35.0,0.0267334,"Results Chronic cZi-DBS had no significant effect on speech intelligibility, and there was no difference in outcome between bilateral and unilateral treatments.","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Sandström', 'Affiliation': 'Division of Speech and Language Pathology, Department of Clinical Sciences, Umeå University, Sweden.'}, {'ForeName': 'Patric', 'Initials': 'P', 'LastName': 'Blomstedt', 'Affiliation': 'Division of Clinical Neuroscience, Department of Clinical Sciences, Umeå University, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Karlsson', 'Affiliation': 'Division of Speech and Language Pathology, Department of Clinical Sciences, Umeå University, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Hartelius', 'Affiliation': 'Division of Speech and Language Pathology, Department of Health and Rehabilitation, Sahlgrenska Academy at the University of Gothenburg, Sweden.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2019_JSLHR-19-00014']
3567,29725191,Sistas Inspiring Sistas Through Activity and Support (SISTAS): Study Design and Demographics of Participants.,"Introduction


Recruiting racial, ethnic, and other underserved minorities into conventional clinic-based and other trials is known to be challenging. The Sistas Inspiring Sistas Through Activity and Support (SISTAS) Program was a one-year randomized controlled trial (RCT) to promote physical activity and healthy eating among AA women in SC to reduce inflammatory biomarkers, which are linked to increased breast cancer (BrCa) risk and mortality. This study describes the development, recruitment, and implementation of the SISTAS clinical trial and provides baseline characteristics of the study participants.
Methods


SISTAS was developed using community-based participatory research (CBPR) approaches. At baseline, study participants completed assessments and underwent clinical measurements and blood draws to measure C-reactive protein (CRP) and interleukin-6 (IL-6). Participants randomized to the intervention received 12 weekly classes followed by nine monthly booster sessions. Post-intervention measurements were assessed at 12-week and 12-month follow-ups.
Results


We recruited a total of 337 women who tended to: be middle-aged (mean age 48.2 years); have some college education; be employed full-time; have Medicare as their primary insurance; be non-smokers; and perceive their personal health as good. On average, the women were pre-hypertensive at baseline (mean systolic blood pressure = 133.9 mm Hg; mean diastolic blood pressure = 84.0 mm Hg) and morbidly obese (mean BMI >40.0 kg/m 2 ); the mean fat mass and fat-free mass among participants were 106.4 lb and 121.0 lb, respectively.
Conclusion


The SISTAS RCT addresses some of the gaps in the literature with respect to CBPR interventions targeting AA women, such as implementing diet and physical activity in CBPR-based studies to decrease BrCa risk.",2018,The Sistas Inspiring Sistas Through Activity and Support (SISTAS),"['study participants', '133.9 mm Hg; mean diastolic blood pressure = 84.0 mm Hg) and morbidly obese (mean', '337 women who tended to: be middle-aged (mean age 48.2 years']",['Sistas Inspiring Sistas Through Activity and Support (SISTAS'],"['mean fat mass and fat-free mass', 'clinical measurements and blood draws to measure C-reactive protein (CRP) and interleukin-6 (IL-6', 'breast cancer (BrCa) risk and mortality']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0190979', 'cui_str': 'Venesection'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",337.0,0.130722,The Sistas Inspiring Sistas Through Activity and Support (SISTAS),"[{'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Bevel', 'Affiliation': 'Cancer Prevention and Control Program, Arnold School of Public Health, University of South Carolina.'}, {'ForeName': 'Oluwole A', 'Initials': 'OA', 'LastName': 'Babatunde', 'Affiliation': 'Cancer Prevention and Control Program, Arnold School of Public Health, University of South Carolina.'}, {'ForeName': 'Sue P', 'Initials': 'SP', 'LastName': 'Heiney', 'Affiliation': 'College of Nursing, University of South Carolina.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Brandt', 'Affiliation': 'Cancer Prevention and Control Program, Arnold School of Public Health, University of South Carolina.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Wirth', 'Affiliation': 'Cancer Prevention and Control Program, Arnold School of Public Health, University of South Carolina.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Hurley', 'Affiliation': 'Cancer Prevention and Control Program, Arnold School of Public Health, University of South Carolina.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'Cancer Prevention and Control Program, Arnold School of Public Health, University of South Carolina.'}, {'ForeName': 'Hiluv', 'Initials': 'H', 'LastName': 'Johnson', 'Affiliation': 'Cancer Prevention and Control Program, Arnold School of Public Health, University of South Carolina.'}, {'ForeName': 'Cassandra M', 'Initials': 'CM', 'LastName': 'Wineglass', 'Affiliation': 'Cancer Prevention and Control Program, Arnold School of Public Health, University of South Carolina.'}, {'ForeName': 'Tatiana Y', 'Initials': 'TY', 'LastName': 'Warren', 'Affiliation': 'Community Works, Bon Secours Baltimore Health Systems; Baltimore, Maryland.'}, {'ForeName': 'E Angela', 'Initials': 'EA', 'LastName': 'Murphy', 'Affiliation': 'Department of Pathology, Microbiology, and Immunology, School of Medicine, University of South Carolina.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Sercy', 'Affiliation': 'Cancer Prevention and Control Program, Arnold School of Public Health, University of South Carolina.'}, {'ForeName': 'Amanda S', 'Initials': 'AS', 'LastName': 'Thomas', 'Affiliation': 'Cancer Prevention and Control Program, Arnold School of Public Health, University of South Carolina.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Hébert', 'Affiliation': 'Cancer Prevention and Control Program, Arnold School of Public Health, University of South Carolina.'}, {'ForeName': 'Swann Arp', 'Initials': 'SA', 'LastName': 'Adams', 'Affiliation': 'Cancer Prevention and Control Program, Arnold School of Public Health, University of South Carolina.'}]",Ethnicity & disease,['10.18865/ed.28.2.75']
3568,31125266,Healthcare resource utilization and associated cost analysis of the PROCLAIM study in patients with stage III non-small-cell lung cancer.,"Objective:  To analyze patient-reported swallowing difficulties, healthcare resource utilization and associated costs during the PROCLAIM study.  Methods:  Patients with stage III non-squamous non-small cell lung cancer received pemetrexed-cisplatin (PemCis) combined with concurrent thoracic radiotherapy followed by consolidation pemetrexed, or concurrent chemoradiotherapy with etoposide-cisplatin (EtoCis) followed by standard consolidation chemotherapy. Patient - reported swallowing function was measured using diaries. Resource utilization (hospitalizations, transfusions, concomitant medications) was compared between treatment arms using Fisher's exact test and independent  t -test. Medical resource use costs were analyzed using nonparametric Wilcoxon rank sum test.  Results:  Patient-reported difficulty in swallowing function (diary score ≥4) was 33.8% in the PemCis arm and 29% in the EtoCis arm. Overall resource use, including hospitalizations, was similar between treatment arms; however, fewer patients in the PemCis arm received transfusions and selected concomitant medications. Concurrent phase analyses were consistent with the overall study. A significantly lower percentage of patients (31.1% vs. 40.8%) were hospitalized in the PemCis arm. Total costs were significantly higher in the PemCis arm. Other medical costs (excluding study treatment costs) during the concurrent phase were lower for patients in the PemCis arm, due to significantly lower hospitalization costs and lower use of concomitant medications. Subgroup analysis yielded similar results.  Conclusions:  Patient-reported difficulty in swallowing post-baseline and resource utilization were consistent with previously reported safety outcomes. In the overall study, higher total costs for PemCis were driven by study drug cost. When adjusting for treatment duration, other monthly medical costs were favorable to PemCis. Patients on pemetrexed remained longer on therapy, suggesting better tolerability.  ClinicalTrials.gov identifier:  NCT00686959.",2019,"Overall resource use, including hospitalizations, was similar between treatment arms; however, fewer patients in the PemCis arm received transfusions and selected concomitant medications.","['Patients with stage III non-squamous non-small cell lung cancer received', 'patients with stage III non-small-cell lung cancer']","['pemetrexed', 'pemetrexed-cisplatin (PemCis) combined with concurrent thoracic radiotherapy followed by consolidation pemetrexed, or concurrent chemoradiotherapy with etoposide-cisplatin (EtoCis) followed by standard consolidation chemotherapy']","['Resource utilization (hospitalizations, transfusions, concomitant medications', 'Overall resource use, including hospitalizations', 'swallowing function (diary score ≥4', 'Total costs', 'hospitalization costs', 'swallowing function', 'tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C4324656', 'cui_str': 'Non-squamous non-small cell lung cancer'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3179017', 'cui_str': 'Consolidation Chemotherapy'}]","[{'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.0563373,"Overall resource use, including hospitalizations, was similar between treatment arms; however, fewer patients in the PemCis arm received transfusions and selected concomitant medications.","[{'ForeName': 'Ramaswamy', 'Initials': 'R', 'LastName': 'Govindan', 'Affiliation': 'Department of Medical Oncology, Washington University School of Medicine , Saint Louis , MO , USA.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Senan', 'Affiliation': 'Department of Radiation Oncology, VU University Medical Center , Amsterdam , The Netherlands.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Dickgreber', 'Affiliation': 'Department of Pulmonology, Mathias - Spital Rheine , Rheine , Germany.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Provencio', 'Affiliation': 'Department of Medical Oncology, Hospital Puerta de Hierro , Madrid , Spain.'}, {'ForeName': 'Yi-Long', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': 'Department of Lung Cancer, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences , Guangzhou , China.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Syrigos', 'Affiliation': 'Department of Medicine, National and Kapodistrian University of Athens , Athens , Greece.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Parente', 'Affiliation': 'Department of Pulmonology, Hospital CUF Porto , Porto , Portugal.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Wilson', 'Affiliation': 'Department of Health Economics, RTI Health Solutions , Research Triangle Park , NC , USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Ziemiecki', 'Affiliation': 'Department of Biostatistics, RTI Health Solutions, Research Triangle Park , NC , USA.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Chouaki', 'Affiliation': 'Eli Lilly and Company , Neuilly-sur-Seine , France.'}, {'ForeName': 'Anwar', 'Initials': 'A', 'LastName': 'Hossain', 'Affiliation': 'Eli Lilly and Company , Indianapolis , IN , USA.'}, {'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'San Antonio', 'Affiliation': 'Lilly España , Madrid , Spain.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Winfree', 'Affiliation': 'Eli Lilly and Company , Indianapolis , IN , USA.'}, {'ForeName': 'Everett E', 'Initials': 'EE', 'LastName': 'Vokes', 'Affiliation': 'Department of Medicine, University of Chicago , Chicago , IL , USA.'}]",Current medical research and opinion,['10.1080/03007995.2019.1623185']
3569,31022066,Literature Commentary: Take Two!,"In this section of Journal of Neuro-Ophthalmology, M. Tariq Bhatti, MD and Mark L. Moster, MD will discuss the following 6 articles:1. Brownlee WJ, Miszkiel KA, Tur C, Barkhof F, Miller DH, Ciccarelli O. Inclusion of optic nerve involvement in dissemination in space criteria for multiple sclerosis. Neurology. 2018;91:e1130-e1134.2. Cossack M, Nabrinsky E, Turner H, Abraham A, Gratton S. Timolol eyedrops in the treatment of acute migraine attacks: a randomized crossover study. JAMA Neurol. 2018;75:1024-1025.3. Rotenstein LS, Torre M, Ramos MA, Rosales RC, Guille C, Sen S, Mata DA. Prevalence of burnout among physicians: a systematic review. JAMA. 2018;320:1131-1150.4. Shosha E, Dubey D, Palace J, Nakashima I, Jacob A, Fujihara K, Takahashi T, Whittam D, Leite MI, Misu T, Yoshiki T, Messina S, Elsone L, Majed M, Flanagan E, Gadoth A, Huebert C, Sagen J, Greenberg BM, Levy M, Banerjee A, Weinshenker B, Pittock SJ. Area postrema syndrome: Frequency, criteria, and severity in AQP4-IgG-positive NMOSD. Neurology. 2018;91:e1642-e1651.5. Raynowska J, Miskin DP, Pramanik B, Asiry S, Anderson T, Boockvar J, Najjar S, Harel A. Retinal vasculopathy with cerebral leukoencephalopathy (RVCL): a rare mimic of tumefactive MS. Neurology. 2018;91:e1423-e1428.6. O'Bryhim BE, Apte RS, Kung N, Coble D, Van Stavern GP. Association of preclinical Alzheimer disease with optical coherence tomographic angiography findings. JAMA Ophthalmol. 2018;136:1242-1248.",2019,"Raynowska J, Miskin DP, Pramanik B, Asiry S, Anderson T, Boockvar J, Najjar S, Harel A. Retinal vasculopathy with cerebral leukoencephalopathy (RVCL): a rare mimic of tumefactive MS.","['acute migraine attacks', 'Area postrema syndrome']","['optical coherence tomographic angiography findings', 'Timolol eyedrops']","['Shosha E, Dubey D, Palace J, Nakashima I, Jacob A, Fujihara K, Takahashi T, Whittam D, Leite MI, Misu T, Yoshiki T, Messina S, Elsone L, Majed M, Flanagan E, Gadoth A, Huebert C, Sagen J, Greenberg BM, Levy M, Banerjee A, Weinshenker B, Pittock SJ', 'Rotenstein LS, Torre M, Ramos MA, Rosales RC, Guille C, Sen S, Mata DA', 'Raynowska J, Miskin DP, Pramanik B, Asiry S, Anderson T, Boockvar J, Najjar S, Harel A. Retinal vasculopathy with cerebral leukoencephalopathy (RVCL']","[{'cui': 'C1740836', 'cui_str': 'Acute migraine'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0228530', 'cui_str': 'Chemoreceptor Trigger Zone'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0040233', 'cui_str': 'Timolol'}, {'cui': 'C0015399', 'cui_str': 'Ophthalmic Drops'}]","[{'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0270612', 'cui_str': 'White Matter Diseases'}]",,0.0237,"Raynowska J, Miskin DP, Pramanik B, Asiry S, Anderson T, Boockvar J, Najjar S, Harel A. Retinal vasculopathy with cerebral leukoencephalopathy (RVCL): a rare mimic of tumefactive MS.",[],Journal of neuro-ophthalmology : the official journal of the North American Neuro-Ophthalmology Society,['10.1097/WNO.0000000000000803']
3570,30219772,Safety Profile of Baricitinib in Patients with Active Rheumatoid Arthritis with over 2 Years Median Time in Treatment.,"OBJECTIVE


Baricitinib is an oral, once-daily selective Janus kinase (JAK1/JAK2) inhibitor for adults with moderately to severely active rheumatoid arthritis (RA). We evaluated baricitinib's safety profile through 288 weeks (up to September 1, 2016) with an integrated database [8 phase III/II/Ib trials, 1 longterm extension (LTE)].
METHODS


The ""all-bari-RA"" group included patients who received any baricitinib dose. Placebo comparison was based on the 6 studies with 4 mg and placebo up to Week 24 (""placebo-4 mg"" dataset). Dose response assessment was based on 4 studies with 2 mg and 4 mg including LTE data (""2 mg-4 mg-extended""). The uncommon events description used the non-controlled all-bari-RA.
RESULTS


There were 3492 patients who received baricitinib for 6637 total patient-years (PY) of exposure (median 2.1 yrs, maximum 5.5 yrs). No differences in rates of death, adverse events leading to drug discontinuation, malignancies, major adverse cardiovascular event (MACE), or serious infections were seen for 4 mg versus placebo or for 4 mg versus 2 mg. Infections including herpes zoster were significantly more frequent for 4 mg versus placebo. Deep vein thrombosis/pulmonary embolism were reported with 4 mg but not placebo [all-bari-RA incidence rate (IR) 0.5/100 PY]; the IR did not differ between doses (0.5 vs 0.6/100 PY, 2 mg vs 4 mg, respectively) or compared to published RA rates. All-bari-RA had 6 cases of lymphoma (IR 0.09/100 PY), 3 gastrointestinal perforations (0.05/100 PY), 10 cases of tuberculosis (all in endemic areas; 0.15/100 PY), and 22 all-cause deaths (0.33/100 PY). IR for malignancies (0.8/100 PY) and MACE (0.5/100 PY) were low and did not increase with prolonged exposure.
CONCLUSION


In this integrated analysis of patients with moderate to severe active RA with exposure up to 5.5 years, baricitinib has an acceptable safety profile in the context of demonstrated efficacy. Trial registration numbers: NCT01185353, NCT00902486, NCT01469013, NCT01710358, NCT01721044, NCT01721057, NCT01711359, and NCT01885078 at clinicaltrials.gov.",2019,"No differences in rates of death, adverse events leading to drug discontinuation, malignancies, major adverse cardiovascular event (MACE), or serious infections were seen for 4 mg versus placebo or for 4 mg versus 2 mg.","['The ""all-bari-RA"" group included patients who received any baricitinib dose', '3492 patients who received baricitinib for 6637 total patient-years (PY) of exposure (median 2.1 yrs, maximum 5.5 yrs', 'adults with moderately to severely active rheumatoid arthritis (RA', 'Patients with Active Rheumatoid Arthritis with over 2 Years Median Time in Treatment']","['selective Janus kinase (JAK1/JAK2) inhibitor', 'placebo', 'Placebo', 'Baricitinib']","['Infections including herpes zoster', 'rates of death, adverse events leading to drug discontinuation, malignancies, major adverse cardiovascular event (MACE), or serious infections', 'Deep vein thrombosis/pulmonary embolism']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0597721', 'cui_str': 'JAK Kinases'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4044947', 'cui_str': 'baricitinib'}]","[{'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0019360', 'cui_str': 'Shingles'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}]",,0.0924926,"No differences in rates of death, adverse events leading to drug discontinuation, malignancies, major adverse cardiovascular event (MACE), or serious infections were seen for 4 mg versus placebo or for 4 mg versus 2 mg.","[{'ForeName': 'Josef S', 'Initials': 'JS', 'LastName': 'Smolen', 'Affiliation': 'From the Division of Rheumatology, Department of Medicine, Medical University of Vienna, Vienna, Austria; Division of Immunology and Rheumatology, Stanford University Medical Center, Palo Alto, California, USA; Division of Rheumatology, Department of Internal Medicine, Keio University, Tokyo, Japan; Lilly Research Laboratories, Eli Lilly and Co., Indianapolis, Indiana, USA; Lilly Research Laboratories, Eli Lilly and Co., Kobe, Japan; Oregon Health Sciences University, Portland, Oregon, USA. josef.smolen@meduniwien.ac.at.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Genovese', 'Affiliation': 'From the Division of Rheumatology, Department of Medicine, Medical University of Vienna, Vienna, Austria; Division of Immunology and Rheumatology, Stanford University Medical Center, Palo Alto, California, USA; Division of Rheumatology, Department of Internal Medicine, Keio University, Tokyo, Japan; Lilly Research Laboratories, Eli Lilly and Co., Indianapolis, Indiana, USA; Lilly Research Laboratories, Eli Lilly and Co., Kobe, Japan; Oregon Health Sciences University, Portland, Oregon, USA.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'From the Division of Rheumatology, Department of Medicine, Medical University of Vienna, Vienna, Austria; Division of Immunology and Rheumatology, Stanford University Medical Center, Palo Alto, California, USA; Division of Rheumatology, Department of Internal Medicine, Keio University, Tokyo, Japan; Lilly Research Laboratories, Eli Lilly and Co., Indianapolis, Indiana, USA; Lilly Research Laboratories, Eli Lilly and Co., Kobe, Japan; Oregon Health Sciences University, Portland, Oregon, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Hyslop', 'Affiliation': 'From the Division of Rheumatology, Department of Medicine, Medical University of Vienna, Vienna, Austria; Division of Immunology and Rheumatology, Stanford University Medical Center, Palo Alto, California, USA; Division of Rheumatology, Department of Internal Medicine, Keio University, Tokyo, Japan; Lilly Research Laboratories, Eli Lilly and Co., Indianapolis, Indiana, USA; Lilly Research Laboratories, Eli Lilly and Co., Kobe, Japan; Oregon Health Sciences University, Portland, Oregon, USA.'}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Macias', 'Affiliation': 'From the Division of Rheumatology, Department of Medicine, Medical University of Vienna, Vienna, Austria; Division of Immunology and Rheumatology, Stanford University Medical Center, Palo Alto, California, USA; Division of Rheumatology, Department of Internal Medicine, Keio University, Tokyo, Japan; Lilly Research Laboratories, Eli Lilly and Co., Indianapolis, Indiana, USA; Lilly Research Laboratories, Eli Lilly and Co., Kobe, Japan; Oregon Health Sciences University, Portland, Oregon, USA.'}, {'ForeName': 'Terence', 'Initials': 'T', 'LastName': 'Rooney', 'Affiliation': 'From the Division of Rheumatology, Department of Medicine, Medical University of Vienna, Vienna, Austria; Division of Immunology and Rheumatology, Stanford University Medical Center, Palo Alto, California, USA; Division of Rheumatology, Department of Internal Medicine, Keio University, Tokyo, Japan; Lilly Research Laboratories, Eli Lilly and Co., Indianapolis, Indiana, USA; Lilly Research Laboratories, Eli Lilly and Co., Kobe, Japan; Oregon Health Sciences University, Portland, Oregon, USA.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'From the Division of Rheumatology, Department of Medicine, Medical University of Vienna, Vienna, Austria; Division of Immunology and Rheumatology, Stanford University Medical Center, Palo Alto, California, USA; Division of Rheumatology, Department of Internal Medicine, Keio University, Tokyo, Japan; Lilly Research Laboratories, Eli Lilly and Co., Indianapolis, Indiana, USA; Lilly Research Laboratories, Eli Lilly and Co., Kobe, Japan; Oregon Health Sciences University, Portland, Oregon, USA.'}, {'ForeName': 'Christina L', 'Initials': 'CL', 'LastName': 'Dickson', 'Affiliation': 'From the Division of Rheumatology, Department of Medicine, Medical University of Vienna, Vienna, Austria; Division of Immunology and Rheumatology, Stanford University Medical Center, Palo Alto, California, USA; Division of Rheumatology, Department of Internal Medicine, Keio University, Tokyo, Japan; Lilly Research Laboratories, Eli Lilly and Co., Indianapolis, Indiana, USA; Lilly Research Laboratories, Eli Lilly and Co., Kobe, Japan; Oregon Health Sciences University, Portland, Oregon, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Riddle Camp', 'Affiliation': 'From the Division of Rheumatology, Department of Medicine, Medical University of Vienna, Vienna, Austria; Division of Immunology and Rheumatology, Stanford University Medical Center, Palo Alto, California, USA; Division of Rheumatology, Department of Internal Medicine, Keio University, Tokyo, Japan; Lilly Research Laboratories, Eli Lilly and Co., Indianapolis, Indiana, USA; Lilly Research Laboratories, Eli Lilly and Co., Kobe, Japan; Oregon Health Sciences University, Portland, Oregon, USA.'}, {'ForeName': 'Tracy E', 'Initials': 'TE', 'LastName': 'Cardillo', 'Affiliation': 'From the Division of Rheumatology, Department of Medicine, Medical University of Vienna, Vienna, Austria; Division of Immunology and Rheumatology, Stanford University Medical Center, Palo Alto, California, USA; Division of Rheumatology, Department of Internal Medicine, Keio University, Tokyo, Japan; Lilly Research Laboratories, Eli Lilly and Co., Indianapolis, Indiana, USA; Lilly Research Laboratories, Eli Lilly and Co., Kobe, Japan; Oregon Health Sciences University, Portland, Oregon, USA.'}, {'ForeName': 'Taeko', 'Initials': 'T', 'LastName': 'Ishii', 'Affiliation': 'From the Division of Rheumatology, Department of Medicine, Medical University of Vienna, Vienna, Austria; Division of Immunology and Rheumatology, Stanford University Medical Center, Palo Alto, California, USA; Division of Rheumatology, Department of Internal Medicine, Keio University, Tokyo, Japan; Lilly Research Laboratories, Eli Lilly and Co., Indianapolis, Indiana, USA; Lilly Research Laboratories, Eli Lilly and Co., Kobe, Japan; Oregon Health Sciences University, Portland, Oregon, USA.'}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Winthrop', 'Affiliation': 'From the Division of Rheumatology, Department of Medicine, Medical University of Vienna, Vienna, Austria; Division of Immunology and Rheumatology, Stanford University Medical Center, Palo Alto, California, USA; Division of Rheumatology, Department of Internal Medicine, Keio University, Tokyo, Japan; Lilly Research Laboratories, Eli Lilly and Co., Indianapolis, Indiana, USA; Lilly Research Laboratories, Eli Lilly and Co., Kobe, Japan; Oregon Health Sciences University, Portland, Oregon, USA.'}]",The Journal of rheumatology,['10.3899/jrheum.171361']
3571,31947205,Comparison of Visual and Auditory Modalities for Upper-Alpha EEG-Neurofeedback .,"Electroencephalography (EEG) neurofeedback (NF) training has been shown to produce long-lasting effects on the improvement of cognitive function as well as the normalization of aberrant brain activity in disease. However, the impact of the sensory modality used as the NF reinforcement signal on training effectiveness has not been systematically investigated. In this work, an EEG-based NF-training system was developed targeting the individual upper-alpha (UA) band and using either a visual or an auditory reinforcement signal, so as to compare the effects of the two sensory modalities. Sixteen healthy volunteers were randomly assigned to the Visual or Auditory group, where a radius-varying sphere or a volume-varying sound, respectively, reflected the relative amplitude of UA measured at EEG electrode Cz. Each participant underwent a total of four NF sessions, of approximately 40 min each, on consecutive days. Both groups showed significant increases in UA at Cz within sessions, and also across sessions. Effects subsequent to NF training were also found beyond the target frequency UA and scalp location Cz, namely in the lower-alpha and theta bands and in posterior brain regions, respectively. Only small differences were found on the EEG between the Visual and Auditory groups, suggesting that auditory reinforcement signals may be as effective as the more commonly used visual signals. The use of auditory NF may potentiate training protocols conducted under mobile conditions, which are now possible due to the increasing availability of wireless EEG systems.",2019,"Effects subsequent to NF training were also found beyond the target frequency UA and scalp location Cz, namely in the lower-alpha and theta bands and in posterior brain regions, respectively.",['Sixteen healthy volunteers'],"['Electroencephalography (EEG) neurofeedback (NF) training', 'NF training']","['UA', 'target frequency UA and scalp location Cz']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0036270', 'cui_str': 'Scalp'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}]",16.0,0.0188559,"Effects subsequent to NF training were also found beyond the target frequency UA and scalp location Cz, namely in the lower-alpha and theta bands and in posterior brain regions, respectively.","[{'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Bucho', 'Affiliation': ''}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Caetano', 'Affiliation': ''}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Vourvopoulos', 'Affiliation': ''}, {'ForeName': 'Floriana', 'Initials': 'F', 'LastName': 'Accoto', 'Affiliation': ''}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Esteves', 'Affiliation': ''}, {'ForeName': 'Sergi Bermudez', 'Initials': 'SB', 'LastName': 'I Badia', 'Affiliation': ''}, {'ForeName': 'Agostinho', 'Initials': 'A', 'LastName': 'Rosa', 'Affiliation': ''}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Figueiredo', 'Affiliation': ''}]",Conference proceedings : ... Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual Conference,['10.1109/EMBC.2019.8856671']
3572,27634921,Altered Sagittal- and Frontal-Plane Kinematics Following High-Intensity Stepping Training Versus Conventional Interventions in Subacute Stroke.,"BACKGROUND


Common locomotor deficits observed in people poststroke include decreased speeds and abnormal kinematics, characterized by altered symmetry, reduced sagittal-plane joint excursions, and use of compensatory frontal-plane behaviors during the swing phase of gait. Conventional interventions utilized to mitigate these deficits often incorporate low-intensity, impairment-based or functional exercises focused on normalizing kinematics, although the efficacy of these strategies is unclear. Conversely, higher-intensity training protocols that provide only stepping practice and do not focus on kinematics have demonstrated gains in walking function, although minimal attention toward gait quality may be concerning and has not been assessed.
OBJECTIVE


The present study evaluated changes in spatiotemporal and joint kinematics following experimental, high-intensity stepping training compared with conventional interventions.
DESIGN


Kinematic data were combined from a randomized controlled trial comparing experimental and conventional training and from a pilot experimental training study.
METHODS


Individuals with gait deficits 1 to 6 months poststroke received up to 40 sessions of either high-intensity stepping training in variable contexts or conventional lower-intensity interventions. Analyses focused on kinematic changes during graded treadmill testing before and following training.
RESULTS


Significant improvements in speed, symmetry, and selected sagittal-plane kinematics favored experimental training over conventional training, although increases in compensatory strategies also were observed. Changes in many kinematic patterns were correlated with speed changes, and increased compensatory behaviors were associated with both stride length gains and baseline impairments.
LIMITATIONS


Limitations include a small sample size and use of multiple statistical comparisons.
CONCLUSIONS


Improved speeds and selected kinematics were observed following high-intensity training, although such training also resulted in increased use of compensatory strategies. Future studies should explore the consequences of utilizing these compensatory strategies despite the observed functional gains.",2017,"RESULTS


Significant improvements in speed, symmetry, and selected sagittal-plane kinematics favored experimental training over conventional training, although increases in compensatory strategies also were observed.","['Subacute Stroke', 'Individuals with gait deficits 1 to 6 months poststroke received']","['up to 40 sessions of either high-intensity stepping training in variable contexts or conventional lower-intensity interventions', 'conventional training', 'high-intensity stepping training', 'High-Intensity Stepping Training Versus Conventional Interventions']","['compensatory behaviors', 'Altered Sagittal- and Frontal-Plane Kinematics', 'speed, symmetry, and selected sagittal-plane kinematics', 'compensatory strategies', 'spatiotemporal and joint kinematics']","[{'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205129', 'cui_str': 'Sagittal (qualifier value)'}, {'cui': 'C4551585', 'cui_str': 'Frontal plane'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0332516', 'cui_str': 'Symmetry'}, {'cui': 'C0935598', 'cui_str': 'Sagittal plane'}, {'cui': 'C0022417', 'cui_str': 'Joints'}]",,0.0353847,"RESULTS


Significant improvements in speed, symmetry, and selected sagittal-plane kinematics favored experimental training over conventional training, although increases in compensatory strategies also were observed.","[{'ForeName': 'Gordhan B', 'Initials': 'GB', 'LastName': 'Mahtani', 'Affiliation': 'G.B. Mahtani, MS, Sensory Motor Performance Program, Rehabilitation Institute of Chicago, Chicago, Illinois.'}, {'ForeName': 'Catherine R', 'Initials': 'CR', 'LastName': 'Kinnaird', 'Affiliation': 'C.R. Kinnaird, MS, Sensory Motor Performance Program, Rehabilitation Institute of Chicago.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Connolly', 'Affiliation': 'M. Connolly, BS, Sensory Motor Performance Program, Rehabilitation Institute of Chicago.'}, {'ForeName': 'Carey L', 'Initials': 'CL', 'LastName': 'Holleran', 'Affiliation': 'C.L. Holleran, DHS, Sensory Motor Performance Program, Rehabilitation Institute of Chicago.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Hennessy', 'Affiliation': 'P.W. Hennessy, PT, MPT, Sensory Motor Performance Program, Rehabilitation Institute of Chicago.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Woodward', 'Affiliation': 'J. Woodward, PT, DPT, Sensory Motor Performance Program, Rehabilitation Institute of Chicago.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Brazg', 'Affiliation': 'G. Brazg, PT, DPT, Sensory Motor Performance Program, Rehabilitation Institute of Chicago.'}, {'ForeName': 'Elliot J', 'Initials': 'EJ', 'LastName': 'Roth', 'Affiliation': 'E.J. Roth, MD, Department of Physical Medicine and Rehabilitation, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'T George', 'Initials': 'TG', 'LastName': 'Hornby', 'Affiliation': 'T.G. Hornby, PT, PhD, Sensory Motor Performance Program, Rehabilitation Institute of Chicago; Department of Physical Medicine and Rehabilitation, Feinberg School of Medicine, Northwestern University; and Department of Physical Medicine and Rehabilitation, Indiana University School of Medicine, 355 W 16th St, Indianapolis, IN 46202 (USA).'}]",Physical therapy,['10.2522/ptj.20160281']
3573,30589607,Salbutamol Nebulization During Noninvasive Ventilation in Exacerbated Chronic Obstructive Pulmonary Disease Patients: A Randomized Controlled Trial.,"Background:  Although nebulizing beta 2-agonists during noninvasive ventilation (NIV) could prove helpful, this administration route has to date never been studied in unstable chronic obstructive pulmonary disease (COPD) patients. We sought to demonstrate that salbutamol could be nebulized through an NIV circuit in COPD exacerbation and improve forced expiratory volume in 1 second (FEV1) as compared with placebo.  Patient and Methods:  This is a bench study to determine the optimal pattern of nebulization followed by a randomized double-blind parallel-group trial comparing salbutamol and placebo aerosols delivered during NIV to 43 intensive care unit patients. Aerosols were generated by a vibrating mesh nebulizer positioned just after the Y-piece. Spirometry was performed immediately before and at several predetermined time points after nebulization. Clinical and biological safety parameters were recorded.  Results:  We failed to demonstrate a difference between salbutamol and placebo when changes in FEV1 were assessed immediately after nebulization (-20 vs. -35 mL,  p  = 0.66). However, FEV1 increased significantly from baseline to 40 minutes after the end of salbutamol nebulization, as compared with placebo (+30 vs. -50 mL,  p  = 0.04). Nebulization was well tolerated.  Conclusion:  When assessing FEV1 changes 40 minutes after the end of 5 mg salbutamol nebulization in patients undergoing NIV, we observed a slight improvement that was statistically significant compared with the changes observed with an equivalent saline volume.",2019,"We failed to demonstrate a difference between salbutamol and placebo when changes in FEV1 were assessed immediately after nebulization (-20 vs. -35 mL,  p  = 0.66).","['unstable chronic obstructive pulmonary disease (COPD) patients', 'Exacerbated Chronic Obstructive Pulmonary Disease Patients', '43 intensive care unit patients']","['salbutamol and placebo aerosols', 'placebo', 'Noninvasive Ventilation', 'salbutamol and placebo', 'salbutamol', 'noninvasive ventilation (NIV', 'Salbutamol Nebulization']","['forced expiratory volume', 'tolerated', 'FEV1']","[{'cui': 'C0443343', 'cui_str': 'Unstable status (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1444749', 'cui_str': 'Exacerbated (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]","[{'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001712', 'cui_str': 'Aerosol (substance)'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}]","[{'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}]",,0.735671,"We failed to demonstrate a difference between salbutamol and placebo when changes in FEV1 were assessed immediately after nebulization (-20 vs. -35 mL,  p  = 0.66).","[{'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Bodet-Contentin', 'Affiliation': '1 Université de Tours, Tours, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Guillon', 'Affiliation': '1 Université de Tours, Tours, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Boulain', 'Affiliation': '4 Réanimation Médicale, Hôpital de la Source, Orléans, France.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Frat', 'Affiliation': '5 Réanimation Médicale, Hôpital Jean Bernard, Poitiers, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Garot', 'Affiliation': '2 Médecine Intensive-Réanimation, CHRU Tours, Tours, France.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Le Pennec', 'Affiliation': '1 Université de Tours, Tours, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Vecellio', 'Affiliation': '1 Université de Tours, Tours, France.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Ehrmann', 'Affiliation': '1 Université de Tours, Tours, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Giraudeau', 'Affiliation': ""6 Centre d'Investigation Clinique Inserm CIC 1415, Tours, France.""}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Tavernier', 'Affiliation': ""6 Centre d'Investigation Clinique Inserm CIC 1415, Tours, France.""}, {'ForeName': 'Pierre-François', 'Initials': 'PF', 'LastName': 'Dequin', 'Affiliation': '1 Université de Tours, Tours, France.'}]",Journal of aerosol medicine and pulmonary drug delivery,['10.1089/jamp.2018.1484']
3574,31395176,Effects of Preoperative Virtual Reality Magnetic Resonance Imaging on Preoperative Anxiety in Patients Undergoing Arthroscopic Knee Surgery: A Randomized Controlled Study.,"PURPOSE


To assess the effect of a preoperative virtual reality (VR) experience of 3-dimensional (3D) reconstructed magnetic resonance images (MRIs) on anxiety reduction in patients undergoing arthroscopic knee surgery.
METHODS


Patients in the VR group watched a 3D model of their own MRI through a VR headset describing the anatomy of the knee as well as their own lesion of interest for an arthroscopic procedure. Patients in the non-VR (NR) group received standard preoperative information about their MRI. The primary outcome for analysis was the Amsterdam Preoperative Anxiety and Information Scale score to measure level of anxiety and the need for information in patients undergoing arthroscopic knee surgery. Secondary outcomes were rated with visual analog scale (VAS) scores measuring patient pain, preparedness, satisfaction, and stress.
RESULTS


Regarding the Amsterdam Preoperative Anxiety and Information Scale score, the sum S (surgery-related anxiety) and sum C (combined anxiety component) subscales showed significantly better outcomes in the VR group (median [interquartile range] for sum S = 2.0 [2.0-4.0], median [quartile 1-quartile 3] sum C = 4.0 [4.0-8.5]) than in the NR group (median [interquartile range] for sum S = 4.9 [3.0-5.0], median [quartile 1-quartile 3] sum C = 8.0 [5.3-9.8]) (P = .014 and P = .005, respectively). Regarding VAS scores, preoperative measures showed significantly better outcomes in satisfaction among VR group patients (95 [90.0-100.0]) in comparison to NR group patients (85 [70.0-96.0]) (P = .010). For postoperative VAS measures, the VR group (satisfaction score = 95 [90.0-100.0], stress score = 15 [2.5-37.5]) showed significantly better outcomes in satisfaction and stress in comparison to the NR group (satisfaction score = 85 [70.0-97.5], stress score = 30 [30.0-50.0]).
CONCLUSIONS


Application of preoperative VR experience of 3D reconstructed knee MRIs in patients undergoing arthroscopic knee surgery reduces anxiety around surgical encounters. The VR patient group was more satisfied overall and less stressed postoperatively. However, perioperative pain and preparedness were not affected by VR exposure.
LEVEL OF EVIDENCE


Level I, randomized controlled trial.",2019,", the sum S (surgery-related anxiety) and sum C (combined anxiety component) subscales showed significantly better outcomes in the VR group (median [interquartile range] for sum S ","['patients undergoing arthroscopic knee surgery', 'Patients Undergoing Arthroscopic Knee Surgery', 'patients undergoing arthroscopic knee surgery reduces anxiety around surgical encounters', 'Patients in the VR group watched a 3D model of their own MRI through a VR headset describing the anatomy of the knee as well as their own lesion of interest for an arthroscopic procedure']","['preoperative VR experience of 3D reconstructed knee MRIs', 'preoperative virtual reality (VR) experience of 3-dimensional (3D) reconstructed magnetic resonance images (MRIs', 'Preoperative Virtual Reality Magnetic Resonance Imaging', 'standard preoperative information about their MRI']","['sum S (surgery-related anxiety) and sum C (combined anxiety component) subscales', 'Amsterdam Preoperative Anxiety and Information Scale score', 'Preoperative Anxiety', 'anxiety reduction', 'perioperative pain and preparedness', 'Amsterdam Preoperative Anxiety and Information Scale score to measure level of anxiety and the need for information', 'rated with visual analog scale (VAS) scores measuring patient pain, preparedness, satisfaction, and stress', 'satisfaction and stress']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0187769', 'cui_str': 'Operative procedure on knee'}, {'cui': 'C0150135', 'cui_str': 'Reducing anxiety'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0332273', 'cui_str': 'Through (qualifier value)'}, {'cui': 'C0003904', 'cui_str': 'Arthroscopy'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]","[{'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0150135', 'cui_str': 'Reducing anxiety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]",,0.0562537,", the sum S (surgery-related anxiety) and sum C (combined anxiety component) subscales showed significantly better outcomes in the VR group (median [interquartile range] for sum S ","[{'ForeName': 'Jae-Hyuk', 'Initials': 'JH', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopaedic Surgery, Hanyang University Guri Hospital, Guri, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Jae Joon', 'Initials': 'JJ', 'LastName': 'Ryu', 'Affiliation': 'Department of Orthopaedic Surgery, Hanyang University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Eunwoo', 'Initials': 'E', 'LastName': 'Nam', 'Affiliation': 'Biostatistical Consulting and Research Laboratory, Hanyang University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hee-Suk', 'Initials': 'HS', 'LastName': 'Lee', 'Affiliation': 'VRAD Inc., Seoul, Republic of Korea.'}, {'ForeName': 'Jin Kyu', 'Initials': 'JK', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedic Surgery, Hanyang University Hospital, Seoul, Republic of Korea. Electronic address: jklee77@hanyang.ac.kr.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2019.02.037']
3575,30689476,Ultrasound Guidance Enhances the Efficiency of Brachial Plexus Block and Ameliorates the Vascular Injury Compared with Nerve Stimulator Guidance in Hand Surgery Patients.,"Background : Nerve stimulation guidance and ultrasound guidance are two major methods that have been widely accepted and applied in axillary brachial plexus block. However, the differences between the effects of these two types of guidance still need to be further elucidated for clinical usage.  Materials and Methods : Overall, 208 patients undergoing elective upper limb surgeries and receiving axillary brachial plexus block were recruited in our study. The patients were randomly assigned to receive either ultrasound guidance (group U,  n  = 112) or nerve stimulation (group N,  n  = 96). Pinprick test was performed for assessing the sensory blockades. The pain was evaluated by visual analog scale (VAS). Reactive oxygen species (ROS) levels were measured by dichloro-dihydro-fluorescein diacetate staining and serum levels of nitric oxide (NO), nitric oxide synthases (NOS), tumor necrosis factor (TNF)-α, and monocyte chemoattractant protein 1 (MCP1) were evaluated by ELISA.  Results : Ultrasound guidance significantly enhanced the quality of the sensory blockade and reduced the VAS scores when compared with the nerve stimulator guidance. In addition, the production of ROS, NO, NOS, TNF-α, and MCP-1 were significantly alleviated by ultrasound guidance.  Conclusion : Ultrasound-guided brachial plexus block relieves pain during operation, provides higher success rates in the nerve block, causes less vascular damage and results in lower levels of inflammatory cytokines secretion when compared with neurostimulator-directed brachial plexus blockage.",2020,"RESULTS


Ultrasound guidance significantly enhanced the quality of the sensory blockade and reduced the VAS scores when compared with the nerve stimulator guidance.","['Hand Surgery Patients', '208 patients undergoing elective upper limb surgeries and receiving axillary brachial plexus block were recruited in our study']","['Nerve Stimulator Guidance', 'nerve stimulation', 'ultrasound guidance', 'Ultrasound Guidance', 'Ultrasound-guided brachial plexus block']","['quality of the sensory blockade', 'pain', 'production of ROS, NO, NOS, TNF-α, and MCP-1', 'visual analog scale (VAS', 'Efficiency of Brachial Plexus Block and Ameliorates the Vascular Injury', 'VAS scores', 'dichloro-dihydro-fluorescein diacetate staining and serum levels of nitric oxide (NO), nitric oxide synthases (NOS), tumor necrosis factor (TNF)-α, and monocyte chemoattractant protein 1 (MCP1', 'Reactive oxygen species (ROS) levels', 'inflammatory cytokines secretion']","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0394701', 'cui_str': 'Brachial plexus block by axillary approach (procedure)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0582124', 'cui_str': 'Neurostimulator, device (physical object)'}, {'cui': 'C0027740', 'cui_str': 'Nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure (procedure)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0394697', 'cui_str': 'Brachial Plexus Anesthesia'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033268'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0394697', 'cui_str': 'Brachial Plexus Anesthesia'}, {'cui': 'C0178324', 'cui_str': 'Vascular Injuries'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0046771', 'cui_str': ""3',6'-diacetylfluorescein""}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0132555', 'cui_str': 'Nitric Oxide Synthase'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0128897', 'cui_str': 'Chemokine (C-C Motif) Ligand 2'}, {'cui': 'C0162772', 'cui_str': 'Active Oxygen'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}]",208.0,0.0223691,"RESULTS


Ultrasound guidance significantly enhanced the quality of the sensory blockade and reduced the VAS scores when compared with the nerve stimulator guidance.","[{'ForeName': 'Liandi', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'The Second Affiliated Hospital of Mudanjiang Medical University, Mudanjiang, Heilongjiang Province, China.'}, {'ForeName': 'Yanjing', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'The Second Affiliated Hospital of Mudanjiang Medical University, Mudanjiang, Heilongjiang Province, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'The Second Affiliated Hospital of Mudanjiang Medical University, Mudanjiang, Heilongjiang Province, China.'}, {'ForeName': 'Xie', 'Initials': 'X', 'LastName': 'Lv', 'Affiliation': 'Xingtai Medical College, Xingtai, Hebei Province, China.'}, {'ForeName': 'Guanghao', 'Initials': 'G', 'LastName': 'Yu', 'Affiliation': 'Medical Imaging Department of Mudanjiang Medical University, Mudanjiang, Heilongjiang Province, China.'}]",Journal of investigative surgery : the official journal of the Academy of Surgical Research,['10.1080/08941939.2018.1539792']
3576,31268524,"A Randomized Feasibility Trial of a Novel, Integrative, and Intensive Virtual Rehabilitation Program for Service Members Post-Acquired Brain Injury.","INTRODUCTION


Acquired Brain Injury, whether resulting from Traumatic brain injury (TBI) or Cerebral Vascular Accident (CVA), represent major health concerns for the Department of Defense and the nation. TBI has been referred to as the ""signature"" injury of recent U.S. military conflicts in Iraq and Afghanistan - affecting approximately 380,000 service members from 2000 to 2017; whereas CVA has been estimated to effect 795,000 individuals each year in the United States. TBI and CVA often present with similar motor, cognitive, and emotional deficits; therefore the treatment interventions for both often overlap. The Defense Health Agency and Veterans Health Administration would benefit from enhanced rehabilitation solutions to treat deficits resulting from acquired brain injuries (ABI), including both TBI and CVA. The purpose of this study was to evaluate the feasibility of implementing a novel, integrative, and intensive virtual rehabilitation system for treating symptoms of ABI in an outpatient clinic. The secondary aim was to evaluate the system's clinical effectiveness.
MATERIALS AND METHODS


Military healthcare beneficiaries with ABI diagnoses completed a 6-week randomized feasibility study of the BrightBrainer Virtual Rehabilitation (BBVR) system in an outpatient military hospital clinic. Twenty-six candidates were screened, consented and randomized, 21 of whom completed the study. The BBVR system is an experimental adjunct ABI therapy program which utilizes virtual reality and repetitive bilateral upper extremity training. Four self-report questionnaires measured participant and provider acceptance of the system. Seven clinical outcomes included the Fugl-Meyer Assessment of Upper Extremity, Box and Blocks Test, Jebsen-Taylor Hand Function Test, Automated Neuropsychological Assessment Metrics, Neurobehavioral Symptom Inventory, Quick Inventory of Depressive Symptomatology-Self-Report, and Post Traumatic Stress Disorder Checklist- Civilian Version. The statistical analyses used bootstrapping, non-parametric statistics, and multilevel/hierarchical modeling as appropriate. This research was approved by the Walter Reed National Military Medical Center and Uniformed Services University of the Health Sciences Institutional Review Boards.
RESULTS


All of the participants and providers reported moderate to high levels of utility, ease of use and satisfaction with the BBVR system (x- = 73-86%). Adjunct therapy with the BBVR system trended towards statistical significance for the measure of cognitive function (ANAM [x- = -1.07, 95% CI -2.27 to 0.13, p = 0.074]); however, none of the other effects approached significance.
CONCLUSION


This research provides evidence for the feasibility of implementing the BBVR system into an outpatient military setting for treatment of ABI symptoms. It is believed these data justify conducting a larger, randomized trial of the clinical effectiveness of the BBVR system.",2020,"Adjunct therapy with the BBVR system trended towards statistical significance for the measure of cognitive function (ANAM [x̄ = -1.07, 95% CI -2.27 to 0.13, p = 0.074]); however, none of the other effects approached significance.
","['outpatient military hospital clinic', 'Walter Reed National Military Medical Center and Uniformed Services University of the Health Sciences Institutional Review Boards', 'Military healthcare beneficiaries with ABI diagnoses', 'Twenty-six candidates were screened, consented and randomized, 21 of whom completed the study', 'Service Members Post-Acquired Brain Injury']",['BrightBrainer Virtual Rehabilitation (BBVR) system'],"['Fugl-Meyer Assessment of Upper Extremity, Box and Blocks Test, Jebsen-Taylor Hand Function Test, Automated Neuropsychological Assessment Metrics, Neurobehavioral Symptom Inventory, Quick Inventory of Depressive Symptomatology-Self-Report, and Post Traumatic Stress Disorder Checklist', 'cognitive function', 'moderate to high levels of utility, ease of use and satisfaction with the BBVR system']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0020012', 'cui_str': 'Military Hospitals'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0086911', 'cui_str': 'Institutional Review Boards'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0270611', 'cui_str': 'Brain Injuries'}]","[{'cui': 'C4042802', 'cui_str': 'Tele-rehabilitation'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0562230', 'cui_str': 'Hand functions (observable entity)'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology (assessment scale)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]",26.0,0.0366565,"Adjunct therapy with the BBVR system trended towards statistical significance for the measure of cognitive function (ANAM [x̄ = -1.07, 95% CI -2.27 to 0.13, p = 0.074]); however, none of the other effects approached significance.
","[{'ForeName': 'Kiara H', 'Initials': 'KH', 'LastName': 'Buccellato', 'Affiliation': 'The Henry M. Jackson Foundation for the Advancement of Military Medicine, 6720 A Rockledge Dr, Bethesda, MD 20817.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Nordstrom', 'Affiliation': 'The Henry M. Jackson Foundation for the Advancement of Military Medicine, 6720 A Rockledge Dr, Bethesda, MD 20817.'}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Murphy', 'Affiliation': 'The Henry M. Jackson Foundation for the Advancement of Military Medicine, 6720 A Rockledge Dr, Bethesda, MD 20817.'}, {'ForeName': 'Grigore C', 'Initials': 'GC', 'LastName': 'Burdea', 'Affiliation': 'Bright Cloud International Corp, 675 US Hwy 1, North Brunswick, NJ 08902.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Polistico', 'Affiliation': 'Bright Cloud International Corp, 675 US Hwy 1, North Brunswick, NJ 08902.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'House', 'Affiliation': 'Bright Cloud International Corp, 675 US Hwy 1, North Brunswick, NJ 08902.'}, {'ForeName': 'Nam', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': 'Bright Cloud International Corp, 675 US Hwy 1, North Brunswick, NJ 08902.'}, {'ForeName': 'Namrata', 'Initials': 'N', 'LastName': 'Grampurohit', 'Affiliation': 'Bright Cloud International Corp, 675 US Hwy 1, North Brunswick, NJ 08902.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Sorensen', 'Affiliation': 'The Henry M. Jackson Foundation for the Advancement of Military Medicine, 6720 A Rockledge Dr, Bethesda, MD 20817.'}, {'ForeName': 'Brad M', 'Initials': 'BM', 'LastName': 'Isaacson', 'Affiliation': 'The Center for Rehabilitation Sciences Research 4301 Jones Bridge Rd, Bethesda, MD 20814.'}, {'ForeName': 'Paul F', 'Initials': 'PF', 'LastName': 'Pasquina', 'Affiliation': 'Department of Rehabilitation Medicine, Uniformed Services University of Health Sciences, 4301 Jones Bridge Rd, Bethesda, MD 20814.'}]",Military medicine,['10.1093/milmed/usz150']
3577,31688793,Severity of hemorrhage and the survival benefit associated with plasma: Results from a randomized prehospital plasma trial.,"BACKGROUND


Recent randomized clinical trial evidence demonstrated a survival benefit with the use of prehospital plasma in patients at risk of hemorrhagic shock. We sought to characterize the survival benefit associated with prehospital plasma relative to the blood transfusion volume over the initial 24 hours. We hypothesized that the beneficial effects of prehospital plasma would be most robust in those with higher severity of hemorrhage.
METHODS


We performed a prespecified secondary analysis using data derived from a prospective randomized prehospital plasma trial. Blood component transfusion volumes were recorded over the initial 24 hours. Massive transfusion (MT) was defined a priori as receiving ≥10 units of red cells in 24 hours. We characterized the 30-day survival benefit of prehospital plasma and the need for MT and overall 24-hour red cell transfusion volume utilizing Kaplan-Meier survival analysis and Cox proportional hazard regression.
RESULTS


There were 501 patients included in this analysis with 230 randomized to prehospital plasma with 104 patients requiring MT. Mortality in patients who received MT were higher compared with those that did not (MT vs. NO-MT, 42% vs. 26%, p = 0.001). Kaplan-Meier survival curves demonstrated early separation in the NO-MT subgroup (log rank p = 0.008) with no survival benefit found in the MT group (log rank p = 0.949). Cox regression analysis verified these findings. When 24-hour red cell transfusion was divided into quartiles, there was a significant independent association with 30-day survival in patients who received 4 to 7 units (hazard ratio, 0.33, 95% confidence interval, 0.14-0.80, p = 0.013).
CONCLUSION


The survival benefits of prehospital plasma was demonstrated only in patients with red cell requirements below the transfusion level of MT. Patients who received 4 to 7 units of red cells demonstrated the most robust independent survival benefit attributable to prehospital plasma transfusion. Prehospital plasma may be most beneficial in those patients with moderate transfusion requirements and mortality risk.
LEVEL OF EVIDENCE


Therapeutic, Level I.",2020,"Mortality in patients who received MT were higher compared to those that did not (MT vs. NO-MT, 42% vs 26%, p=0.001).","['501 patients included in this analysis with 230 randomized to prehospital plasma with 104 patients requiring MT', 'patients at risk of hemorrhagic shock']",['Massive transfusion (MT'],"['Mortality', '30-day survival', '30-day survival benefit of prehospital plasma', 'Blood component transfusion volumes', 'survival benefits of prehospital plasma', 'survival benefit']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0036982', 'cui_str': 'Shock, Hemorrhagic'}]","[{'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0085430', 'cui_str': 'Blood Component Transfusion'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",501.0,0.481917,"Mortality in patients who received MT were higher compared to those that did not (MT vs. NO-MT, 42% vs 26%, p=0.001).","[{'ForeName': 'Vincent P', 'Initials': 'VP', 'LastName': 'Anto', 'Affiliation': 'From the Department of Surgery (V.P.A., J.B., M.N., R.F., B.Z., J.S.), Department of Emergency Medicine (F.X.G.), University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Surgery (B.D.), University of Tennessee Health Science Center, Knoxville; Department of Surgery (R.M.), Vanderbilt University Medical Center, Nashville, Tennessee; Department of Surgery, University of Louisville, Louisville (B.H.), Kentucky; Department of Surgery, MetroHealth Medical Center (J.C.), Case Western Reserve University, Cleveland, Ohio; and Department of Surgery (H.P.), University of Texas Southwestern, Parkland Memorial Hospital, Dallas, Texas.'}, {'ForeName': 'Frank X', 'Initials': 'FX', 'LastName': 'Guyette', 'Affiliation': ''}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Daley', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Miller', 'Affiliation': ''}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Harbrecht', 'Affiliation': ''}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Claridge', 'Affiliation': ''}, {'ForeName': 'Herb', 'Initials': 'H', 'LastName': 'Phelan', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Neal', 'Affiliation': ''}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Forsythe', 'Affiliation': ''}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Zuckerbraun', 'Affiliation': ''}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Sperry', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002530']
3578,31530227,"Treatment of Persistent Post-Traumatic Headache and Post-Concussion Symptoms Using Repetitive Transcranial Magnetic Stimulation: A Pilot, Double-Blind, Randomized Controlled Trial.","Persistent post-traumatic headache (PTH) after mild traumatic brain injury is one of the most prominent and highly reported persistent post-concussion symptoms (PPCS). Non-pharmacological treatments, including non-invasive neurostimulation technologies, have been proposed for use. Our objective was to evaluate headache characteristics at 1 month after repetitive transcranial magnetic stimulation (rTMS) treatment in participants with PTH and PPCS. A double-blind, randomized, sham-controlled, pilot clinical trial was performed on 20 participants (18-65 years) with persistent PTH (International Classification of Headache Disorders, 3rd edition) and PPCS (International Classification of Diseases, Tenth Revision). Ten sessions of rTMS therapy (10 Hz, 600 pulses, 70% resting motor threshold amplitude) were delivered to the left dorsolateral pre-frontal cortex. The primary outcome was a change in headache frequency or severity at 1 month post-rTMS. Two-week-long daily headache diaries and clinical questionnaires assessing function, PPCS, cognition, quality of life, and mood were completed at baseline, post-treatment, and at 1, 3, and 6 months post-rTMS. A two-way (treatment × time) mixed analyisis of variance indicated a significant overall time effect for average headache severity ( F (3,54)  = 3.214;  p  = 0.03) and a reduction in headache frequency at 1 month post-treatment (#/2 weeks, REAL -5.2 [standard deviation {SD} = 5.8]; SHAM, -3.3 [SD = 7.7]). Secondary outcomes revealed an overall time interaction for headache impact, depression, post-concussion symptoms, and quality of life. There was a significant reduction in depression rating in the REAL group between baseline and 1 month post-treatment, with no change in the SHAM group (Personal Health Questionnaire - 9; REAL, -4.3 [SD = 3.7[  p  = 0.020]; SHAM, -0.7 [SD = 4.7;  p  = 1.0]; Bonferroni corrected). In the REAL group, 60% returned to work whereas only 10% returned in the SHAM group ( p  = 0.027). This pilot study demonstrates an overall time effect on headache severity, functional impact, depression, PPCS, and quality of life after rTMS treatment in participants with persistent PTH; however, findings were below clinical significance thresholds. There was a 100% response rate, no dropouts, and minimal adverse effects, warranting a larger phase II study. Clinicaltrials.gov: NCT03691272.",2020,"Secondary outcomes revealed an overall time interaction for headache impact, depression, post-concussion symptoms, and quality of life.","['mild traumatic brain injury (mTBI', 'participants with PTH and PPCS', 'twenty participants (18-65 years) with persistent PTH (ICHD-3) and PPCS (ICD-10', 'participants with persistent PTH']","['rTMS', 'repetitive transcranial magnetic stimulation (rTMS', 'rTMS therapy (10Hz, 600 pulses, 70% resting motor threshold amplitude']","['headache frequency', 'daily headache diaries and clinical questionnaires assessing function, PPCS, cognition, quality of life, and mood', 'depression rating', 'average headache severity', 'overall time interaction for headache impact, depression, post-concussion symptoms, and quality of life', 'change in headache frequency or severity', 'headache characteristics', 'headache severity, functional impact, depression, PPCS, and quality of life']","[{'cui': 'C3508472', 'cui_str': 'Mild Traumatic Brain Injury'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}]","[{'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C3661947', 'cui_str': 'Daily headache'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0034380'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0546983', 'cui_str': 'Post-Concussion Symptoms'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",600.0,0.570685,"Secondary outcomes revealed an overall time interaction for headache impact, depression, post-concussion symptoms, and quality of life.","[{'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Stilling', 'Affiliation': 'University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Paxman', 'Affiliation': 'University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Mercier', 'Affiliation': 'University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Liu Shi', 'Initials': 'LS', 'LastName': 'Gan', 'Affiliation': 'University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Farnaz', 'Initials': 'F', 'LastName': 'Amoozegar', 'Affiliation': 'University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Dukelow', 'Affiliation': 'University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Oury', 'Initials': 'O', 'LastName': 'Monchi', 'Affiliation': 'University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Chantel', 'Initials': 'C', 'LastName': 'Debert', 'Affiliation': 'University of Calgary, Calgary, Alberta, Canada.'}]",Journal of neurotrauma,['10.1089/neu.2019.6692']
3579,31823379,Can I join in? Multiple case study investigation of play performance generalisation for children with autism spectrum disorder from dyad to triad.,"INTRODUCTION


Children with autism spectrum disorder (ASD) have difficulties with play, social interaction with peers and generalisation of intervention outcomes. The Ultimate Guide to Play, Language and Friendship (PLF) has demonstrated effectiveness in improving play performance of children with ASD and their typically developing (TD) peers. The aim of this investigation was to examine the changes in play performance when an additional TD child is added to an existing dyad of a child with ASD and a TD playmate to inform future delivery and adaptations of the intervention.
METHODS


Participants in this multiple case study design were five children with ASD and their TD peer who completed a dyad intervention as part of a randomised control trial investigation of the PLF and an additional TD peer who joined the play dyad. A trained occupational therapist delivered an adapted version of the PLF to the triad over four clinic sessions. An independent rater scored each child (N = 15) on The Test of Playfulness at pre- and post-triad intervention. Line graphs were used to examine case data and compare to dyad play performance and patterns of interaction.
RESULTS


Four of the five children with ASD generalised their play performance from the dyad to the triad social environment. However, the triad intervention did not demonstrate improvements in play performance. The play performance scores for the children with ASD and their TD peers were variable and demonstrated changes in their play pattern from the dyad to the triad.
CONCLUSION


This investigation delivered preliminary evidence of play performance generalisation from a dyad to a triad with TD peers for children with ASD. Careful consideration of characteristics of all playmates is recommended for delivering the intervention to support play performance of children with ASD.",2020,"The Ultimate Guide to Play, Language and Friendship (PLF) has demonstrated effectiveness in improving play performance of children with ASD and their typically developing (TD) peers.","['Participants in this multiple case study design were five children with ASD and their TD peer who completed a dyad intervention as part of a randomised control trial investigation of the PLF and an additional TD peer who joined the play dyad', 'children with ASD', 'children with ASD and their TD peers', 'Children with autism spectrum disorder (ASD', 'children with autism spectrum disorder from dyad to triad', 'children with ASD and their typically developing (TD) peers']","['Language and Friendship (PLF', 'play performance generalisation']","['play performance', 'play performance scores']","[{'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0085973', 'cui_str': 'Case Study'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]","[{'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0178647', 'cui_str': 'Friendship'}, {'cui': 'C0032214', 'cui_str': 'Play'}]","[{'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0356023,"The Ultimate Guide to Play, Language and Friendship (PLF) has demonstrated effectiveness in improving play performance of children with ASD and their typically developing (TD) peers.","[{'ForeName': 'Cally', 'Initials': 'C', 'LastName': 'Kent', 'Affiliation': 'School of Occupational Therapy and Social Work, Curtin University, Perth, WA, USA.'}, {'ForeName': 'Reinie', 'Initials': 'R', 'LastName': 'Cordier', 'Affiliation': 'School of Occupational Therapy and Social Work, Curtin University, Perth, WA, USA.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Joosten', 'Affiliation': 'School of Allied Health, Australian Catholic University, Melbourne, Vic., Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Wilkes-Gillan', 'Affiliation': 'Faculty of Health Sciences, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Bundy', 'Affiliation': 'Department of Occupational Therapy, Colorado State University, Fort Collins, CO, USA.'}]",Australian occupational therapy journal,['10.1111/1440-1630.12635']
3580,31935109,Time to exhaustion during cycling is not well predicted by critical power calculations.,"Three to 5 cycling tests to exhaustion allow prediction of time to exhaustion (TTE) at power output based on calculation of critical power (CP). We aimed to determine the accuracy of CP predictions of TTE at power outputs habitually endured by cyclists. Fourteen endurance-trained male cyclists underwent 4 randomized cycle-ergometer TTE tests at power outputs eliciting ( i ) mean Wingate anaerobic test (WAnT mean ), ( ii ) maximal oxygen consumption, ( iii ) respiratory compensation threshold (VT 2 ), and ( iv ) maximal lactate steady state (MLSS). Tests were conducted in duplicate with coefficient of variation of 5%-9%. Power outputs were 710 ± 63 W for WAnT mean , 366 ± 26 W for maximal oxygen consumption, 302 ± 31 W for VT 2  and 247 ± 20 W for MLSS. Corresponding TTE were 00:29 ± 00:06, 03:23 ± 00:45, 11:29 ± 05:07, and 76:05 ± 13:53 min:s, respectively. Power output associated with CP was only 2% lower than MLSS (242 ± 19 vs. 247 ± 20 W;  P  < 0.001). The CP predictions overestimated TTE at WAnT mean  (00:24 ± 00:10 mm:ss) and MLSS (04:41 ± 11:47 min:s), underestimated TTE at VT 2  (-04:18 ± 03:20 mm:ss;  P  < 0.05), and correctly predicted TTE at maximal oxygen consumption. In summary, CP accurately predicts MLSS power output and TTE at maximal oxygen consumption. However, it should not be used to estimate time to exhaustion in trained cyclists at higher or lower power outputs (e.g., sprints and 40-km time trials).  Novelty  CP calculation enables to predict TTE at any cycling power output. We tested those predictions against measured TTE in a wide range of cycling power outputs. CP appropriately predicted TTE at maximal oxygen consumption intensity but err at higher and lower cycling power outputs.",2020,Power-output associated with CP was only 2% lower than MLSS (242±19 vs. 247±20 W; P<0.001).,['Fourteen endurance-trained male cyclists'],['• Critical power (CP) calculation'],"['mean Wingate anaerobic test (WAnTmean), ii) VO2max, iii) respiratory compensation threshold (VT2) and iv) maximal lactate steady state (MLSS', 'Novelty bullets']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0152058', 'cui_str': 'Compensation (finding)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0336699', 'cui_str': 'Bullet, device (physical object)'}]",14.0,0.0296645,Power-output associated with CP was only 2% lower than MLSS (242±19 vs. 247±20 W; P<0.001).,"[{'ForeName': 'Jesus G', 'Initials': 'JG', 'LastName': 'Pallarés', 'Affiliation': 'Human Performance and Sports Science Laboratory. University of Murcia, 30720, Murcia, Spain.'}, {'ForeName': 'Jose R', 'Initials': 'JR', 'LastName': 'Lillo-Bevia', 'Affiliation': 'Human Performance and Sports Science Laboratory. University of Murcia, 30720, Murcia, Spain.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Morán-Navarro', 'Affiliation': 'Human Performance and Sports Science Laboratory. University of Murcia, 30720, Murcia, Spain.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Cerezuela-Espejo', 'Affiliation': 'Human Performance and Sports Science Laboratory. University of Murcia, 30720, Murcia, Spain.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Mora-Rodriguez', 'Affiliation': 'Exercise Physiology Laboratory at Toledo. University of Castilla-La Mancha, Avda Carlos III, s/n, 47051, Toledo, Spain.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0637']
3581,31964203,Contribution of diet to gut microbiota and related host cardiometabolic health: diet-gut interaction in human health.,"Obesity and cardiometabolic diseases in both developed and developing counties in a state of nutrition transition are often related to diet, which also play a major role in shaping human gut microbiota. The human gut harbors diverse microbes that play an essential role in the well-being of their host. Complex interactions between diet and microorganisms may lead to beneficial or detrimental outcomes to host cardiometabolic health. Despite numerous studies using rodent models indicated that high-fat diet may disrupt protective functions of the intestinal barrier and contribute to inflammatory processes, evidence from population-based study is still limited. In our recent study of a 6-month randomized controlled-feeding trial, we showed that high-fat, low-carbohydrate diet was associated with unfavorable changes in gut microbiota, fecal microbial metabolites, and plasma proinflammatory factors in healthy young adults. Here, we provide an overview and extended discussion of our key findings, and outline important future directions.",2020,"Obesity and cardiometabolic diseases in both developed and developing counties in a state of nutrition transition are often related to diet, which also play a major role in shaping human gut microbiota.","['human health', 'healthy young adults']","['high-fat, low-carbohydrate diet']","['gut microbiota, fecal microbial metabolites, and plasma proinflammatory factors', 'Obesity and cardiometabolic diseases']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0259836', 'cui_str': 'Diet, Carbohydrate-Restricted'}]","[{'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.0199388,"Obesity and cardiometabolic diseases in both developed and developing counties in a state of nutrition transition are often related to diet, which also play a major role in shaping human gut microbiota.","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wan', 'Affiliation': 'Department of Food Science and Nutrition, Zhejiang University , Hangzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Department of Food Science and Nutrition, Zhejiang University , Hangzhou, China.'}, {'ForeName': 'Jiaomei', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Institute of Nutrition and Health, Qingdao University , Qingdao, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""No. 1 Department of Nutrition, Chinese People's Liberation Army General Hospital , Beijing, China.""}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': ""No. 1 Department of Nutrition, Chinese People's Liberation Army General Hospital , Beijing, China.""}, {'ForeName': 'Fenglei', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Food Science and Nutrition, Zhejiang University , Hangzhou, China.'}, {'ForeName': 'Duo', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Institute of Nutrition and Health, Qingdao University , Qingdao, China.'}]",Gut microbes,['10.1080/19490976.2019.1697149']
3582,31985275,Positional Changes in Arterial Oxygen Saturation and End-Tidal Carbon Dioxide at High Altitude: Medex 2015.,"Background:  Body position alters aspects of pulmonary function in health and disease. Although studies have assessed positional effects on the heart and lungs, little is known about positional changes in gas exchange parameters at high altitude. We hypothesized that following ascent, supine positioning would cause lower oxygen saturation than sitting, partially due to decreased ventilation and increased partial pressure of end-tidal carbon dioxide (Petco 2 ).  Materials and Methods:  Twenty-eight healthy subjects were studied at sea level and following gradual ascent to 5150 m. After 10 minutes of sitting rest, subjects were studied for 5 minutes each in the sitting, supine, and prone positions with the order randomly assigned. Pulse oximeter oxygen saturation (SpO 2 ), minute ventilation (V E ), end-tidal O 2  (Peto 2 ) and Petco 2 , oxygen consumption, and CO 2  production were continuously measured. Alveolar ventilation (V A ) was calculated from the measured parameters.  Results:  At high altitude, V E  was not affected by body position (12.96 ± 3.09 and 11.54 ± 3.45 L/min in the sitting and supine positions, respectively,  p  = 0.255). Petco 2  increased from sitting to supine (22.8 ± 3.1 to 23.5 ± 3.3 mm Hg,  p  < 0.005), but V E  and Petco 2  were not different between the supine and prone positions. Calculated V A  was not significantly affected by body position at either sea level or high altitude. SpO 2  decreased from 81.3% ± 4.4% sitting to 78.8% ± 6.0% supine ( p  = 0.025), with a mean positional SpO 2  difference of 2.5% ± 4.9% (95% confidence interval 0.6%-4.4%). SpO 2  was not different between the supine and prone positions. Twenty-two of 28 subjects had lower SpO 2  supine compared with sitting.  Conclusions:  These results extend earlier low-altitude studies and demonstrate the importance of postural regulation in different environments. As 79% of subjects had lower SpO 2  while supine than sitting, control of body position is necessary for SpO 2  comparisons at altitude to be meaningful.",2020,"SpO 2  decreased from 81.3% ± 4.4% sitting to 78.8% ± 6.0% supine ( p  = 0.025), with a mean positional SpO 2  difference of 2.5% ± 4.9% (95% confidence interval 0.6%-4.4%).","['Twenty-eight healthy subjects were studied at sea level and following gradual ascent to 5150\u2009m', 'pulmonary function in health and disease']",[],"['Alveolar ventilation (V A ', 'Petco 2  increased from sitting to supine', 'Pulse oximeter oxygen saturation (SpO 2 ), minute ventilation (V E ), end-tidal O 2  (Peto 2 ) and Petco 2 , oxygen consumption, and CO 2  production', 'Arterial Oxygen Saturation and End-Tidal Carbon Dioxide at High Altitude', 'partial pressure of end-tidal carbon dioxide (Petco 2 ', 'SpO 2']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0036493', 'cui_str': 'Sea (environment)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439833', 'cui_str': 'Gradual (qualifier value)'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",[],"[{'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V), function (observable entity)'}, {'cui': 'C0231966', 'cui_str': 'Alveolar gas volume, function (observable entity)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0182109', 'cui_str': 'Pulse oximeter (physical object)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0231963', 'cui_str': 'Volume of expired gas (observable entity)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0033268'}, {'cui': 'C2711000', 'cui_str': 'SaO2 - Arterial oxygen saturation'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0238617', 'cui_str': 'High altitude (physical force)'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}]",28.0,0.0256855,"SpO 2  decreased from 81.3% ± 4.4% sitting to 78.8% ± 6.0% supine ( p  = 0.025), with a mean positional SpO 2  difference of 2.5% ± 4.9% (95% confidence interval 0.6%-4.4%).","[{'ForeName': 'Arlena', 'Initials': 'A', 'LastName': 'Kuenzel', 'Affiliation': 'Department of Anaesthesia, Royal Infirmary of Edinburgh, NHS Lothian, Edinburgh, Scotland.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Marshall', 'Affiliation': 'Sheffield Teaching Hospitals, NHS Foundation Trust, Sheffield, United Kingdom.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Verges', 'Affiliation': 'INSERM U1042 and HP2 Laboratory, Grenoble Alpes University, Grenoble, France.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Anholm', 'Affiliation': 'Division of Pulmonary, Critical Care, Hyperbaric and Sleep Medicine, Department of Medicine, Loma Linda University School of Medicine, Loma Linda, California, USA.'}]",High altitude medicine & biology,['10.1089/ham.2019.0066']
3583,31416637,"An open-label, prospective, randomized, controlled, multicenter, phase 1b study of StrataGraft skin tissue versus autografting in patients with deep partial-thickness thermal burns.","OBJECTIVE


This open-label, controlled, randomized study assessed the safety, tolerability, and efficacy of StrataGraft tissue compared to autograft in the treatment of deep partial-thickness (DPT) burns.
METHODS


Thirty subjects with DPT thermal burns (3%-43% total body surface area) were treated with StrataGraft tissue as follows: cohort 1, ≤220 cm 2  refrigerated tissue; cohort 2, ≤440 cm 2  refrigerated tissue; and cohort 3, ≤440 cm 2  cryopreserved tissue. On each subject, two comparable areas of DPT burn were randomized to receive StrataGraft tissue or autograft. Coprimary end points were the percent area of the StrataGraft tissue treatment site undergoing salvage autografting by Day 28 and wound closure of treatment sites by 3 months.
RESULTS


By Day 28, no StrataGraft tissue treatment sites underwent autografting. By 3 months, 93% and 100% of the StrataGraft tissue and autograft treatment sites achieved complete wound closure, respectively. No significant differences in observer total and overall opinion POSAS scores between StrataGraft tissue and autograft treatment sites were observed at any timepoint. The most common adverse event was pruritus (17%).
CONCLUSIONS


StrataGraft tissue treatment of DPT thermal burns reduced the need for autograft, resulted in wound closure and treatment-site cosmesis comparable to that of autograft, and was well tolerated.",2019,No significant differences in observer total and overall opinion POSAS scores between StrataGraft tissue and autograft treatment sites were observed at any timepoint.,"['patients with deep partial-thickness thermal burns', 'deep partial-thickness (DPT) burns', 'Thirty subjects with DPT thermal burns (3%-43% total body surface area) were treated with StrataGraft tissue as follows: cohort 1, ≤220\u2009cm 2  refrigerated tissue; cohort 2, ≤440\u2009cm 2  refrigerated tissue; and cohort 3, ≤440\u2009cm 2  cryopreserved tissue']","['StrataGraft tissue or autograft', 'StrataGraft skin tissue versus autografting']","['tolerated', 'observer total and overall opinion POSAS scores', 'percent area of the StrataGraft tissue treatment site undergoing salvage autografting by Day 28 and wound closure of treatment sites', 'complete wound closure', 'safety, tolerability, and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0443275', 'cui_str': 'Partial thickness (qualifier value)'}, {'cui': 'C0701836', 'cui_str': 'Thermal burn (morphologic abnormality)'}, {'cui': 'C0433405', 'cui_str': 'Deep partial thickness burn (morphologic abnormality)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0636923', 'cui_str': 'phenyl benzenethiosulfinate'}, {'cui': 'C0439175', 'cui_str': '% of total (qualifier value)'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}, {'cui': 'C0684084', 'cui_str': 'Skin tissue'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0871010', 'cui_str': 'Opinions'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0337950', 'cui_str': 'Site of care'}, {'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",30.0,0.0204084,No significant differences in observer total and overall opinion POSAS scores between StrataGraft tissue and autograft treatment sites were observed at any timepoint.,"[{'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Holmes', 'Affiliation': 'Department of Surgery, Wake Forest University School of Medicine, Winston-Salem, NC, United States. Electronic address: jholmes@wakehealth.edu.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Schurr', 'Affiliation': 'Department of Surgery, University of Colorado Hospital Burn Center, Denver, CO, United States.'}, {'ForeName': 'Booker T', 'Initials': 'BT', 'LastName': 'King', 'Affiliation': 'Clinical Division, United States Army Institute of Surgical Research, Joint Base, San Antonio, TX, United States.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Foster', 'Affiliation': 'Department of Surgery, The Arizona Burn Center Valleywise Health, Phoenix, AZ, United States.'}, {'ForeName': 'Lee D', 'Initials': 'LD', 'LastName': 'Faucher', 'Affiliation': 'Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, WI, United States.'}, {'ForeName': 'Mary A', 'Initials': 'MA', 'LastName': 'Lokuta', 'Affiliation': 'Stratatech, A Mallinckrodt Company, Madison, WI, United States.'}, {'ForeName': 'Allen R', 'Initials': 'AR', 'LastName': 'Comer', 'Affiliation': 'Stratatech, A Mallinckrodt Company, Madison, WI, United States.'}, {'ForeName': 'Peggy J', 'Initials': 'PJ', 'LastName': 'Rooney', 'Affiliation': 'Stratatech, A Mallinckrodt Company, Madison, WI, United States.'}, {'ForeName': 'Kelly F', 'Initials': 'KF', 'LastName': 'Barbeau', 'Affiliation': 'Stratatech, A Mallinckrodt Company, Madison, WI, United States.'}, {'ForeName': 'Stuart T', 'Initials': 'ST', 'LastName': 'Mohoney', 'Affiliation': 'Stratatech, A Mallinckrodt Company, Madison, WI, United States.'}, {'ForeName': 'Angela L F', 'Initials': 'ALF', 'LastName': 'Gibson', 'Affiliation': 'Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, WI, United States.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Lynn Allen-Hoffmann', 'Affiliation': 'Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, WI, United States; Stratatech, A Mallinckrodt Company, Madison, WI, United States; Department of Pathology and Laboratory Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, United States.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2019.07.021']
3584,31769585,"""A Multi-center, randomized, double blinded, comparative study of two hyaluronic acid fillers for temporary restoration of mid-face volume in Asians"".","BACKGROUND


There have been few studies using hyaluronic acid fillers to restore mid-face volume deficit especially in Asians.
AIMS


This study compared the efficacy and safety of two highly cohesive hyaluronic acid fillers, Neuramis® Volume Lidocaine and Juvederm® Voluma® with Lidocaine (VYC-20L), for temporary restoration of mid-face volume in Asians.
PATIENTS/METHODS


A total of 88 subjects with moderate to severe age-related mid-face volume deficit on the Mid-Face Volume Deficit Scale (MFVDS) received Neuramis® Volume Lidocaine on one side and VYC-20L on the other side of the face. Response was defined as a ≥1 point reduction in MFVDS at 24 weeks after the injection by photographic assessment. Secondary end points included photographic and live assessments of MFVDS and its changes at week 4, 12, and 24; global aesthetic improvements, as assessed by the investigators and the subjects at each visit; and the proportion of subjects who received touch-up treatment.
RESULTS


The response rates of the sides treated with Neuramis® Volume Lidocaine and VYC-20L were identical (96.39%) at week 24, demonstrating that Neuramis® Volume Lidocaine was noninferior to VYC-20L. Photographic and live assessments of MFVDS and its changes, global aesthetic improvement, and the proportion of subjects who received touch-up treatment did not differ significantly during follow-up.
CONCLUSIONS


Neuramis® Volume Lidocaine was not inferior to VYC-20L in temporarily restoring mid-face volume at 24 weeks after treatment. Both of these highly cohesive hyaluronic acid fillers can be used effectively and safely for the correction of mid-face volume loss in Asians.",2020,"CONCLUSIONS


Neuramis® Volume Lidocaine was not inferior to VYC-20L in temporarily restoring mid-face volume at 24 weeks after treatment.","['88 subjects with moderate to severe age-related mid-face volume deficit on the Mid-Face Volume Deficit Scale (MFVDS) received', 'temporary restoration of mid-face volume in Asians']","['Lidocaine (VYC-20L', 'Neuramis® Volume Lidocaine', 'cohesive hyaluronic acid fillers, Neuramis® Volume Lidocaine', 'hyaluronic acid fillers', 'Lidocaine']","['photographic and live assessments of MFVDS and its changes at week 4, 12, and 24; global aesthetic improvements', 'efficacy and safety', 'response rates']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",88.0,0.0275443,"CONCLUSIONS


Neuramis® Volume Lidocaine was not inferior to VYC-20L in temporarily restoring mid-face volume at 24 weeks after treatment.","[{'ForeName': 'Joon Min', 'Initials': 'JM', 'LastName': 'Jung', 'Affiliation': 'Department of Dermatology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Woo Shun', 'Initials': 'WS', 'LastName': 'Lee', 'Affiliation': 'Medytox Inc., Seoul, Korea.'}, {'ForeName': 'Hak Tae', 'Initials': 'HT', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Young Seon', 'Initials': 'YS', 'LastName': 'Moon', 'Affiliation': 'Department of Dermatology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Seung Hwan', 'Initials': 'SH', 'LastName': 'Paik', 'Affiliation': 'Department of Dermatology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Woo Jin', 'Initials': 'WJ', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sung Eun', 'Initials': 'SE', 'LastName': 'Chang', 'Affiliation': 'Department of Dermatology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Mi Woo', 'Initials': 'MW', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Chong Hyun', 'Initials': 'CH', 'LastName': 'Won', 'Affiliation': 'Department of Dermatology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Beom Joon', 'Initials': 'BJ', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13218']
3585,31917172,Comparison of Neoadjuvant and Adjuvant Chemotherapy in Muscle-invasive Bladder Cancer.,"BACKGROUND


We use observational methods to compare impact of perioperative chemotherapy timing (ie, neoadjuvant and adjuvant) on overall survival (OS) in muscle-invasive bladder cancer because there is no head-to-head randomized trial, and patient factors may influence decision-making.
PATIENTS AND METHODS


Using Surveillance, Epidemiology, and End Results-Medicare data, we identified patients receiving cystectomy for muscle-invasive bladder cancer diagnosed between 2004 and 2013. Patients were classified as receiving neoadjuvant or adjuvant chemotherapy. Propensity of receiving neoadjuvant chemotherapy was determined using gradient boosted models. Inverse probability of treatment weighted survival curves were adjusted for 13 demographic, socioeconomic, temporal, and oncologic covariates.
RESULTS


We identified 1342 patients who received neoadjuvant (n = 676) or adjuvant chemotherapy (n = 666) with a median follow-up of 23 months (interquartile range, 9-55 months). Inverse probability of treatment weighted adjustment allows comparison of the groups head-to-head as well as counterfactual scenarios (eg, effect if those getting one treatment were to receive the other). The average treatment effect (ie, ""head-to-head"" comparison) of adjuvant compared with neoadjuvant on OS was not significant (hazard ratio, 1.14; 95% confidence interval, 0.99-1.31). However, the average treatment effect of the treated (ie, the effect if the neoadjuvant patients were to receive adjuvant instead) was associated with a 33% increase in risk of mortality if they were given adjuvant therapy instead (hazard ratio, 1.33; 95% confidence interval, 1.12-1.57).
CONCLUSION


Significant treatment selection bias was noted in peri-cystectomy timing, which limits the ability to discriminate differential efficacy of these 2 approaches with observational data. However, patients with higher propensity to receive neoadjuvant therapy were predicted to have increased OS with approach, in keeping with existing paradigms from trial data.",2020,"The average treatment effect (ie, ""head-to-head"" comparison) of adjuvant compared with neoadjuvant on OS was not significant (hazard ratio, 1.14; 95% confidence interval, 0.99-1.31).","['1342 patients who received neoadjuvant (n\xa0= 676) or', 'muscle-invasive bladder cancer', 'patients receiving cystectomy for muscle-invasive bladder cancer diagnosed between 2004 and 2013', 'Muscle-invasive Bladder Cancer']","['neoadjuvant chemotherapy', 'Neoadjuvant and Adjuvant Chemotherapy', 'perioperative chemotherapy timing (ie, neoadjuvant and adjuvant', 'neoadjuvant or adjuvant chemotherapy', 'adjuvant chemotherapy']","['overall survival (OS', 'risk of mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}, {'cui': 'C0010651', 'cui_str': 'Cystectomy'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",1342.0,0.241733,"The average treatment effect (ie, ""head-to-head"" comparison) of adjuvant compared with neoadjuvant on OS was not significant (hazard ratio, 1.14; 95% confidence interval, 0.99-1.31).","[{'ForeName': 'Liam C', 'Initials': 'LC', 'LastName': 'Macleod', 'Affiliation': 'Department of Urology, University of Pittsburgh Medical Center, Pittsburgh, PA; Department of Urology, Asante Rogue Regional Medical Center, Medford, OR. Electronic address: liamcmacleod@gmail.com.'}, {'ForeName': 'Mina M', 'Initials': 'MM', 'LastName': 'Fam', 'Affiliation': 'Department of Urology, Jersey Shore University Medical Center, Neptune, NJ.'}, {'ForeName': 'Jonathan G', 'Initials': 'JG', 'LastName': 'Yabes', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Nathan E', 'Initials': 'NE', 'LastName': 'Hale', 'Affiliation': 'Department of Urology, Charleston Area Medical Center, Charleston, WV.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Turner', 'Affiliation': 'Department of Urology, University of Pittsburgh Medical Center, Pittsburgh, PA.'}, {'ForeName': 'Samia H', 'Initials': 'SH', 'LastName': 'Lopa', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Gingrich', 'Affiliation': 'Division of Urology, Department of Surgery, Duke University, Durham, NC.'}, {'ForeName': 'Tudor', 'Initials': 'T', 'LastName': 'Borza', 'Affiliation': 'Department of Urology, University of Wisconsin, Madison, WI.'}, {'ForeName': 'Ted A', 'Initials': 'TA', 'LastName': 'Skolarus', 'Affiliation': 'Division of Oncology, Department of Urology, University of Michigan, Ann Arbor, MI; Dow Division for Urologic Health Service Research, Department of Urology, University of Michigan, Ann Arbor, MI; VA Health Services Research & Development, Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Davies', 'Affiliation': 'Department of Urology, University of Pittsburgh Medical Center, Pittsburgh, PA.'}, {'ForeName': 'Bruce L', 'Initials': 'BL', 'LastName': 'Jacobs', 'Affiliation': 'Department of Urology, University of Pittsburgh Medical Center, Pittsburgh, PA.'}]",Clinical genitourinary cancer,['10.1016/j.clgc.2019.12.011']
3586,31953736,"Comparison of the effectiveness of fractional 1550-nm erbium fiber laser and 0.05% tretinoin cream in the treatment of acanthosis nigricans: a prospective, randomized, controlled trial.","Acanthosis nigricans is a common dermatological problem. There are currently limited clinical trials to determine the efficacy and safety of laser treatments. To compare the efficacy of fractional 1550-nm erbium fiber laser versus 0.05% tretinoin cream for the treatment of acanthosis nigricans at neck, a randomized, controlled, assessor-blinded study was conducted in 18 subjects with acanthosis nigricans at the neck. All patients were treated with both fractional 1550-nm erbium fiber laser and 0.05% tretinoin cream on each side of the neck. The laser side was treated with three treatment sessions, with a 4-week interval of 1550-nm fractional erbium laser. Another side was treated with 0.05% tretinoin cream daily at bedtime for 12 weeks. We evaluated at baseline, with a 4-week interval until 4 weeks after the last treatment. The efficacy was assessed by skin color ratio, melanin index, average roughness, photographic evaluation, patients' satisfaction, and the adverse effects. At the study endpoint, week 12, the mean Visiometer-average roughness showed greater reduction in laser-treated side (24.65%) than tretinoin side (22.94%) (p = 0.004). Laser-treated side also showed greater percentage of skin color ratio reduction, melanin index reduction, and better mean of photographic-based evaluation percentage change from the baseline than tretinoin side with no significant different (p = 0.331, p = 0.116, p = 0.327, respectively). The study showed one post-inflammatory hyperpigmentation in tretinoin side. Regarding to the average roughness, fractional 1550-nm erbium fiber laser was superior to 0.05% tretinoin cream for treatment of neck-acanthosis nigricans with less side effect. Fractional 1550-nm erbium fiber laser could be considered as an alternative treatment for acanthosis nigricans.",2020,"At the study endpoint, week 12, the mean Visiometer-average roughness showed greater reduction in laser-treated side (24.65%) than tretinoin side (22.94%) (p = 0.004).","['acanthosis nigricans at neck', '18 subjects with acanthosis nigricans at the neck', 'acanthosis nigricans']","['fractional 1550-nm erbium fiber laser and 0.05% tretinoin cream', 'fractional 1550-nm erbium fiber laser versus 0.05% tretinoin cream', 'tretinoin cream', 'Fractional 1550-nm erbium fiber laser']","['percentage of skin color ratio reduction, melanin index reduction', ""skin color ratio, melanin index, average roughness, photographic evaluation, patients' satisfaction, and the adverse effects""]","[{'cui': 'C0221270', 'cui_str': 'Acanthosis (morphologic abnormality)'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0000889', 'cui_str': 'Acanthosis Nigrican'}]","[{'cui': 'C0014688', 'cui_str': 'Erbium'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0040845', 'cui_str': 'retinoic acid'}, {'cui': 'C1378128', 'cui_str': 'Cream'}]","[{'cui': 'C0037290', 'cui_str': 'Skin Tone'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0025196', 'cui_str': 'Melanins'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",18.0,0.0225464,"At the study endpoint, week 12, the mean Visiometer-average roughness showed greater reduction in laser-treated side (24.65%) than tretinoin side (22.94%) (p = 0.004).","[{'ForeName': 'Pannika', 'Initials': 'P', 'LastName': 'Leerapongnan', 'Affiliation': 'Skin Center, Srinakharinwirot University, Bangkok, 10110, Thailand.'}, {'ForeName': 'Natthachat', 'Initials': 'N', 'LastName': 'Jurairattanaporn', 'Affiliation': 'Skin Center, Srinakharinwirot University, Bangkok, Thailand.'}, {'ForeName': 'Silada', 'Initials': 'S', 'LastName': 'Kanokrungsee', 'Affiliation': 'Skin Center, Srinakharinwirot University, Bangkok, Thailand.'}, {'ForeName': 'Montree', 'Initials': 'M', 'LastName': 'Udompataikul', 'Affiliation': 'Skin Center, Srinakharinwirot University, Bangkok, Thailand. umontree@yahoo.com.'}]",Lasers in medical science,['10.1007/s10103-019-02944-9']
3587,30637907,Magnetic stimulation of carotid sinus as a treatment for hypertension.,"Previously, we reported that magnetic stimulation of carotid sinus (MSCS) could lower arterial pressure in rabbits. In this randomized, sham-controlled pilot study, we evaluated the effects of MSCS on blood pressure in pre-hypertensive and hypertensive subjects. A total of 15 subjects with blood pressure higher than 130/80 mm Hg were randomized to receive sham or 1Hz MSCS. The changes of systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MAP) during treatment were compared between groups. The heart rate variability (HRV) and baroreflex sensitivity (BRS) before, during, and after treatments were analyzed. Reduction of SBP was significantly greater in subjects with MSCS than those with sham stimulation (6.6 ± 0.4 vs -2.5 ± 0.4 mm Hg, P < 0.001). Reduction of DBP was significantly greater in subjects with MSCS than those with sham stimulation (1.2 ± 0.2 vs -2.8 ± 0.2 mm Hg, P < 0.001). Reduction of MAP was significantly greater in subjects with MSCS than those with sham stimulation (1.4 ± 0.3 mm Hg vs -4.0 ± 0.3 mm Hg, P < 0.001). Reduction of HR was significantly greater in subjects with MSCS than those with sham stimulation (0.5 ± 0.5 vs -1.9 ± 0.3 beats/min, P = 0.002). BRS increased from 6.85 ± 0.77 to 8.79 ± 0.95 ms/mm Hg after MSCS compared with that at baseline (P = 0.027). Thus, MSCS can lower blood pressure and heart rate in pre-hypertensive and hypertensive subject, warranting further study for establishing MSCS as a treatment for hypertension.",2019,"Reduction of MAP was significantly greater in subjects with MSCS than those with sham stimulation (1.4 ± 0.3 mm Hg vs -4.0 ± 0.3 mm Hg, P ","['pre-hypertensive and hypertensive subjects', '15 subjects with blood pressure higher than 130/80\xa0mm', 'rabbits', 'hypertension']","['sham or 1Hz MSCS', 'magnetic stimulation of carotid sinus (MSCS', 'MSCS']","['Reduction of MAP', 'blood pressure', 'Reduction of HR', 'blood pressure and heart rate', 'systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MAP', 'BRS', 'heart rate variability (HRV) and baroreflex sensitivity (BRS', 'Reduction of SBP', 'Reduction of DBP']","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0020538', 'cui_str': 'Blood Pressure, High'}, {'cui': 'C3887509', 'cui_str': 'Rabbits'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0190568', 'cui_str': 'Stimulation of carotid sinus (procedure)'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0206162', 'cui_str': 'Reflex, Baroreceptor'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}]",15.0,0.0571718,"Reduction of MAP was significantly greater in subjects with MSCS than those with sham stimulation (1.4 ± 0.3 mm Hg vs -4.0 ± 0.3 mm Hg, P ","[{'ForeName': 'Rongrong', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Zhengze', 'Initials': 'Z', 'LastName': 'Dai', 'Affiliation': 'Department of Neurology, Jinling Clinical College of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Ruidong', 'Initials': 'R', 'LastName': 'Ye', 'Affiliation': 'Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Xinfeng', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Zhengkun', 'Initials': 'Z', 'LastName': 'Xia', 'Affiliation': 'Department of Pediatrics, Jinling Hospital, Medical School of Nanjing University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Gelin', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, Jiangsu, China.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13470']
3588,31863406,One-Day Acceptance and Commitment Therapy Compared to Support for Depressed Migraine Patients: a Randomized Clinical Trial.,"In patients with migraine, depression is associated with poorer medical prognosis, decreased quality of life, and increased risk of suicidality and disability; yet, behavioral interventions have rarely been investigated. The current study compared the efficacy of two 1-day (5- to 6-h) interventions for co-occurring migraine and depression: (1) acceptance and commitment therapy plus migraine education (ACT-ED), and (2) support plus migraine education (S-ED). One hundred and thirty-six patients with comorbid depression and migraine were randomized to a treatment. One hundred and three (76%) completed the ACT-ED (N = 56) or S-ED (N = 47) workshop. Primary outcomes were depression diagnosis and symptoms. Secondary outcomes were anxiety symptoms, headache-related disability and general functioning, and quality of life. Assessments were completed at baseline and 3 and 6 months following the workshop. At the 6-month follow-up, on categorical outcomes, a significantly greater number of people in the ACT-ED condition no longer met criteria for a major depressive episode and exhibited a > 50% drop in symptoms on the Hamilton Rating Scale of Depression. Similarly, though, weaker results were found when examining depressive symptoms dimensionally. On secondary outcomes, people in the ACT-ED condition exhibited significantly greater improvements in anxiety, headache-related disability, and quality of social relationships, compared to S-ED, No differences between groups were observed in general functioning. A 1-day (5- to 6-h) ACT workshop can deliver substantial and lasting benefits to depressed migraineurs, over and above those provided by group support and education. This approach is an attractive alternative to weekly psychotherapy. Clinicaltrials.gov # NCT02108678.",2020,"On secondary outcomes, people in the ACT-ED condition exhibited significantly greater improvements in anxiety, headache-related disability, and quality of social relationships, compared to S-ED, No differences between groups were observed in general functioning.","['Depressed Migraine Patients', 'One hundred and thirty-six patients with comorbid depression and migraine']","['two 1-day (5- to 6-h) interventions for co-occurring migraine and depression: (1) acceptance and commitment therapy plus migraine education (ACT-ED), and (2) support plus migraine education']","['anxiety, headache-related disability, and quality of social relationships', 'quality of life, and increased risk of suicidality and disability', 'depression diagnosis and symptoms', 'anxiety symptoms, headache-related disability and general functioning, and quality of life', 'general functioning', 'Hamilton Rating Scale of Depression']","[{'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0222045'}]",136.0,0.0886674,"On secondary outcomes, people in the ACT-ED condition exhibited significantly greater improvements in anxiety, headache-related disability, and quality of social relationships, compared to S-ED, No differences between groups were observed in general functioning.","[{'ForeName': 'Lilian N', 'Initials': 'LN', 'LastName': 'Dindo', 'Affiliation': 'Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center, Holcombe, Houston, TX, 77030, USA. lilian.dindo@bcm.edu.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Recober', 'Affiliation': ""University of Pennsylvania & the Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Chadi A', 'Initials': 'CA', 'LastName': 'Calarge', 'Affiliation': 'Department of Internal Medicine, Section of Health Services Research, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Bridget M', 'Initials': 'BM', 'LastName': 'Zimmerman', 'Affiliation': 'Department of Biostatistics, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Aliza', 'Initials': 'A', 'LastName': 'Weinrib', 'Affiliation': 'Department of Anesthesia and Pain Management, Toronto General Hospital, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Marchman', 'Affiliation': 'Department of Psychology, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Turvey', 'Affiliation': 'Department of Psychiatry, University of Iowa, Iowa City, IA, USA.'}]",Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics,['10.1007/s13311-019-00818-0']
3589,31444884,"Effects of vorapaxar on clot characteristics, coagulation, inflammation, and platelet and endothelial function in patients treated with mono- and dual-antiplatelet therapy.","BACKGROUND


Vorapaxar is indicated with standard antiplatelet therapy (APT) in patients with a history of myocardial infarction (MI) or peripheral arterial disease (PAD).
OBJECTIVES


To evaluate the comparative effects of vorapaxar on platelet-fibrin clot characteristics (PFCC), coagulation, inflammation, and platelet and endothelial function during treatment with daily 81 mg aspirin (A), 75 mg clopidogrel (C), both (C + A), or neither.
METHODS


Thrombelastography, conventional platelet aggregation (PA), ex vivo endothelial function by ENDOPAT, coagulation, platelet activation/inflammation marked by urinary 11-dehydrothromboxane B 2  (UTxB 2  ) and safety were determined in patients who were APT naïve (n = 21), on C (n = 8), on A (n = 29), and on A + C (n = 23) during 1 month of vorapaxar therapy and 1 month of offset.
RESULTS


Vorapaxar had no effect on PFCC, ADP- or collagen-induced PA, thrombin time, fibrinogen, PT, PTT, von Willebrand factor (vWF), D-dimer, or endothelial function (P > .05 in all groups). Inhibition of SFLLRN (PAR-1 activating peptide)-stimulated PA by vorapaxar was accelerated by A + C at 2 hours (P < .05 versus other groups) with nearly complete inhibition by 30 days that persisted through 30 days after discontinuation in all groups (P < .001). SFLLRN-induced PA during offset was lower in APT patients versus APT-naïve patients (P < .05). Inhibition of UTxB 2  was observed in APT-naive patients treated with vorapaxar (P < .05). Minor bleeding was only observed in C-treated patients.
CONCLUSION


Vorapaxar had no influence on PFCC measured by thrombelastography, coagulation, or endothelial function irrespective of APT. Inhibition of protease activated receptor (PAR)-1 mediated platelet aggregation by vorapaxar was accelerated by A + C and offset was prolonged by concomitant APT. Vorapaxar-induced anti-inflammatory effects were observed in non-aspirin-treated patients.",2020,SFLLRN-induced PA during offset was lower in APT patients versus APT-naïve patients (P < .05).,"['patients who were APT naïve (n\xa0=\xa021', 'patients treated with mono- and dual-antiplatelet therapy', 'patients with a history of myocardial infarction (MI) or peripheral arterial disease (PAD']","['vorapaxar', 'vorapaxar therapy', 'standard antiplatelet therapy (APT', 'aspirin (A), 75\xa0mg clopidogrel (C), both (C\xa0+\xa0A), or neither']","['conventional platelet aggregation (PA), ex vivo endothelial function by ENDOPAT, coagulation, platelet activation/inflammation marked by urinary 11-dehydrothromboxane B 2  (UTxB 2  ) and safety', 'platelet-fibrin clot characteristics (PFCC), coagulation, inflammation, and platelet and endothelial function', 'Minor bleeding', 'PFCC measured by thrombelastography, coagulation, or endothelial function irrespective of APT', 'Vorapaxar-induced anti-inflammatory effects', 'PFCC, ADP- or collagen-induced PA, thrombin time, fibrinogen, PT, PTT, von Willebrand factor (vWF), D-dimer, or endothelial function', 'clot characteristics, coagulation, inflammation, and platelet and endothelial function', 'Inhibition of UTxB 2']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003645', 'cui_str': 'APT'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C1275835', 'cui_str': 'Past history of myocardial infarction'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}]","[{'cui': 'C2974521', 'cui_str': 'vorapaxar'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0003645', 'cui_str': 'APT'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0677599', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0032173', 'cui_str': 'Platelet Activation'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0045550', 'cui_str': 'sodium 2,5-dichloro-4-bromophenol'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0015982', 'cui_str': 'Fibrin'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0040017', 'cui_str': 'Thromboelastography'}, {'cui': 'C0003645', 'cui_str': 'APT'}, {'cui': 'C2974521', 'cui_str': 'vorapaxar'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0001459', 'cui_str': ""Adenosine 5'-Pyrophosphate""}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0677634', 'cui_str': 'Reptilase Time'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0060323', 'cui_str': 'D-dimer fragments'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]",,0.0244454,SFLLRN-induced PA during offset was lower in APT patients versus APT-naïve patients (P < .05).,"[{'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Bliden', 'Affiliation': 'Inova Center for Thrombosis Research and Drug Development, Inova Heart and Vascular Institute, Fairfax, VA, USA.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Chaudhary', 'Affiliation': 'Division of Hospital Internal Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Athan', 'Initials': 'A', 'LastName': 'Kuliopulos', 'Affiliation': 'Center for Hemostasis and Thrombosis Research, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Tran', 'Affiliation': 'Inova Center for Thrombosis Research and Drug Development, Inova Heart and Vascular Institute, Fairfax, VA, USA.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Taheri', 'Affiliation': 'Inova Center for Thrombosis Research and Drug Development, Inova Heart and Vascular Institute, Fairfax, VA, USA.'}, {'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Tehrani', 'Affiliation': 'Inova Center for Thrombosis Research and Drug Development, Inova Heart and Vascular Institute, Fairfax, VA, USA.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Rosenblatt', 'Affiliation': 'Inova Center for Thrombosis Research and Drug Development, Inova Heart and Vascular Institute, Fairfax, VA, USA.'}, {'ForeName': 'Eliano', 'Initials': 'E', 'LastName': 'Navarese', 'Affiliation': 'Inova Center for Thrombosis Research and Drug Development, Inova Heart and Vascular Institute, Fairfax, VA, USA.'}, {'ForeName': 'Udaya S', 'Initials': 'US', 'LastName': 'Tantry', 'Affiliation': 'Sinai Center for Thrombosis Research, Sinai Hospital of Baltimore, Baltimore, MD, USA.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Gurbel', 'Affiliation': 'Inova Center for Thrombosis Research and Drug Development, Inova Heart and Vascular Institute, Fairfax, VA, USA.'}]",Journal of thrombosis and haemostasis : JTH,['10.1111/jth.14616']
3590,31924631,'Not clinically effective but cost-effective' - paradoxical conclusions in randomised controlled trials with 'doubly null' results: a cross-sectional study.,"OBJECTIVES


Randomised controlled trials in healthcare increasingly include economic evaluations. Some show small differences which are not statistically significant. Yet these sometimes come to paradoxical conclusions such as: 'the intervention is not clinically effective' but 'is probably cost-effective'. This study aims to quantify the extent of non-significant results and the types of conclusions drawn from them.
DESIGN


Cross-sectional retrospective analysis of randomised trials published by the UK's National Institute for Health Research (NIHR) Health Technology Assessment programme. We defined as 'doubly null' those trials that found non-statistically significant differences in both primary outcome and cost per patient. Paradoxical was defined as concluding in favour of an intervention, usually compared with placebo or usual care. No human participants were involved. Our sample was 226 randomised trial projects published by the Health Technology Assessment programme 2004 to 2017. All are available free online.
RESULTS


The 226 projects contained 193 trials with a full economic evaluation. Of these 76 (39%) had at least one 'doubly null' comparison. These 76 trials contained 94 comparisons. In these 30 (32%) drew economic conclusions in favour of an intervention. Overall report conclusions split roughly equally between those favouring the intervention (14), and those favouring either the control (7) or uncertainty (9).
DISCUSSION


Trials with 'doubly null' results and paradoxical conclusions are not uncommon. The differences observed in cost and quality-adjustedlife year were small and non-statistically significant. Almost all these trials were also published in leading peer-reviewed journals. Although some guidelines for reporting economic results require cost-effectiveness estimates regardless of statistical significance, the interpretability of paradoxical results has nowhere been addressed.
CONCLUSIONS


Reconsideration is required of the interpretation of cost-effectiveness analyses in randomised controlled trials with 'doubly null' results, particularly when economics favours a novel intervention.",2020,The differences observed in cost and quality-adjustedlife year were small and non-statistically significant.,"[""UK's National Institute for Health Research (NIHR""]",['placebo'],['cost and quality-adjustedlife year'],"[{'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035168'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",226.0,0.147697,The differences observed in cost and quality-adjustedlife year were small and non-statistically significant.,"[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Raftery', 'Affiliation': 'Faculty of Medicine, Southampton University, Southampton, UK j.p.raftery@soton.ac.uk.'}, {'ForeName': 'H C', 'Initials': 'HC', 'LastName': 'Williams', 'Affiliation': 'University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Aileen', 'Initials': 'A', 'LastName': 'Clarke', 'Affiliation': 'Division of Health Sciences, University of Warwick, Coventry, UK.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Thornton', 'Affiliation': 'University of Nottingham, Nottingham, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh No. 9, Bioquarter, Edinburgh, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Snooks', 'Affiliation': 'Medicine, Swansea University, Swansea, UK.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Stein', 'Affiliation': 'PenTAG, University of Exeter Medical School, Exeter, UK.'}]",BMJ open,['10.1136/bmjopen-2019-029596']